id|nct_id|outcome_type|title|description|time_frame|population|anticipated_posting_month_year|units|units_analyzed|dispersion_type|param_type
1|NCT02987374|Other Pre-specified|Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.|Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.|Day -5 to 180 post-immunization||||||
2|NCT02987374|Secondary|Number of Participants With Related Adverse Events||Day 0 to 180 post-immunization|Number of participants with related adverse events up to 180 days post immunization||Participants|||Count of Participants
3|NCT02987374|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 180 post-immunization|10 participants received the 2011-2012 Fluzone IIV3 vaccine||Participants|||Count of Participants
4|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases By Dose of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and >=50001 mg.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.The unexposed arm was not planned to be analyzed for this outcome measure.||Cases|||Number
5|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
6|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases by Duration of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.||Cases|||Number
7|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
8|NCT02958956|Secondary|Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone|Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.||Cases|||Number
9|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. The various times since initiation include <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
10|NCT02958956|Primary|Number of 10 Most Common Cancers Associated Cases|Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Cases|||Number
11|NCT02958956|Primary|Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. Cox proportional hazards regression modeling was used to provide point and interval estimates of the relative hazard of the 10 most common cancers associated with ever use of pioglitazone. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.||Ratio||95% Confidence Interval|Number
12|NCT02920749|Secondary|Costs of Anaesthesia|total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros|1 hour|||euros|total cost of anaesthesia|Standard Deviation|Mean
13|NCT02920749|Primary|Drug Consumption|drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams|at induction one dose and during anaesthesia mg/1 hour|||mg||Standard Deviation|Mean
684|NCT02615717|Secondary|Beck Anxiety Inventory (BAI)|Self-report measure of 20 symptoms of anxiety Range: 0-60 all items summed Higher score indicates higher severity|within three days|||units on a scale||Standard Deviation|Mean
14|NCT02919657|Primary|Weekly Blood Draws to Measure Blood Protein Levels|"Each week the 20 participants will have blood drawn to measure their blood protein levels.~Each participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable.~10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6.~10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6.~These measurements will read in g/dl"|6 weeks per intervention|||grams per deciliter||Standard Deviation|Mean
15|NCT02882152|Secondary|Postoperative Bleeding|Postoperative bleeding volume (ml)|baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours|||mL||Standard Deviation|Mean
16|NCT02882152|Primary|Analgesic Efficacy|Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).|baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours|||units on a scale||Standard Deviation|Mean
17|NCT02862106|Secondary|Change From Baseline by Vsit for HBeAg Titer.|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|week95,108,120,144|intend to treat population||IU/ML||Standard Deviation|Mean
18|NCT02862106|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;||week95,108,120,144|intent to treat population||percentage of participants|||Number
19|NCT02862106|Secondary|Change From Baseline by Visit for Serum HBV DNA||week95,108,120,144|intention to treat population||log_10 IU/mL||Standard Deviation|Mean
20|NCT02862106|Secondary|The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit||week95,108,120,144|intention to treat population||percentage of participants|||Number
21|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBsAg and HBsAb.||week95,108,120,144|intent-to-treat population||percentage of participants|||Number
22|NCT02862106|Secondary|The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 96,108,120,144||week95,108,120,144|intention to treat population||percentage of participants|||Number
23|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb.||week95,108,120,144|intention to treat population||percentage of paricipants|||Number
24|NCT02862106|Secondary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144||week95,108,120,144|Intention to treat population||percentage of paricipant|||Number
25|NCT02862106|Primary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint|Intent-to-treat population||percentage of participants|||Number
26|NCT02840916|Secondary|Body Fat Percentage (BFP)|The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks|||% of body weight||Standard Deviation|Mean
27|NCT02840916|Secondary|Waist-to-buttock Ratio (WBR)|The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks|||ratio||Standard Deviation|Mean
28|NCT02840916|Primary|Body Mass Index (BMI)|The BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion.|up to 3 weeks, 3 months after study completion|||kg/m^2||Standard Deviation|Mean
29|NCT02839772|Secondary|Amharic Dermatology Life Quality Index (DLQI)|The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.||units on a scale||Standard Deviation|Mean
30|NCT02839772|Secondary|Change in Largest Foot Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||Centimetres|Foot circumference|Standard Deviation|Mean
31|NCT02839772|Secondary|Change in Largest Lower Leg Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||Centimetres|Legs|Standard Deviation|Mean
32|NCT02839772|Secondary|Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds|Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.|From baseline monthly for 3 months|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be collected and analysed for all participants in a single group.||Spearman's correlation coefficient|||Number
33|NCT02839772|Secondary|Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)|Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be analysed for all participants as a single group.||Number of work days lost.|||Number
34|NCT02839772|Secondary|Number of Wounds on Lower Legs/Feet of Participants.|"Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse.~Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data was pre-specified to be analysed for all participants as a single group.||Wounds|Feet/legs||Number
35|NCT02839772|Secondary|Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.|Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.||Participants|||Number
36|NCT02839772|Secondary|Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit|Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.||Trophic skin changes|||Number
37|NCT02839772|Secondary|Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit|Podoconiosis Staging System (1-5) used with 5 the most severe stage. This staging system was specifically designed for those with podoconiosis. Legs with stages 1, 2 or 3 were categorised with mild/moderate disease and those with stages 4,5 with severe disease.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants as a single group.||Legs/feet|Legs||Number
38|NCT02839772|Primary|Change in Stratum Corneum Hydration at Top of Feet|Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left foot in the control group and one left and one right foot in the experimental group were not affected by podoconiosis so they were not included in the study.||Arbitrary units|Feet|Standard Deviation|Mean
39|NCT02839772|Primary|Change in Stratum Corneum Hydration at Base of Outer Lower Leg|Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.||Arbitrary units|Legs|Standard Deviation|Mean
40|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.|SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.||Arbitrary units|Legs|Standard Deviation|Mean
41|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs|Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||Arbitrary units|Legs|Standard Deviation|Mean
42|NCT02839772|Primary|Change in TEWL at Top of Feet|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.~TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group. One left foot leg in the control group and one right and one left foot in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Feet|Standard Deviation|Mean
336|NCT02717754|Secondary|Half-Life (t1/2) of Oseltamivir and RO0640802|t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||hour||Standard Deviation|Mean
43|NCT02839772|Primary|Change in TEWL at Base of Outer Lower Legs|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.~TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post-intervention data was missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Legs|Standard Deviation|Mean
44|NCT02839772|Primary|Change in TEWL at Mid-point Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Legs|Standard Deviation|Mean
45|NCT02839772|Primary|Change in TEWL at Top of Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data was missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.||g/m2/h|Legs|Standard Deviation|Mean
46|NCT02829775|Secondary|Number of Participants With Overall Tumor Response|Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.|Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)|All participants who were recruited in the study.||participants|||Number
47|NCT02829775|Primary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.|Baseline up to approximately 3 years|All participants who were recruited in the study.||participants|||Number
48|NCT02829463|Primary|Infrapatellar Fat Pad Volume in MRI||immediately after the subjects did the MRI|||mm*mm*mm||Standard Deviation|Median
49|NCT02828137|Primary|Index of Microcirculatory Resistance|IMR in low NLR group : 21.94 ± 12.87 IMR in intermediate NLR group : 23.22 ± 12.73 IMR in high NLR group : 32.95 ± 20.60|3 months|||IMR||Standard Deviation|Mean
50|NCT02823080|Other Pre-specified|Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy|-severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6.|0-6 days|||GI manifestations|||Number
51|NCT02823080|Secondary|Daily Total Leucocytic Count|TLC(x 1ooo cells/ml)|0 -8days.|||1000 cells/ml||Standard Deviation|Mean
52|NCT02823080|Secondary|Ultrasound Detected Severity Grades of Ascites From Days 0-8|-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8.|0-8 days|||US detected ascitis|||Number
53|NCT02823080|Secondary|Daily Hematocrits Value|Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%)|0-8 days.|||percentge||Standard Deviation|Mean
54|NCT02823080|Secondary|Daily Numerical Pain Visual Analogue Scale Score|-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain .|8 days.|||units on a scale||Standard Deviation|Mean
55|NCT02823080|Primary|Daily Maximal Ovarian Diameter|MOD (maximal ovarian diameter in mm) were evaluated daily.|8 days|||mm||Standard Deviation|Mean
56|NCT02823080|Primary|Daily Serum E2 Levels|Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.|8 days|||picograms/ml||Standard Deviation|Mean
57|NCT02822287|Secondary|Local Oral Tolerability|Local oral tolerability was assessed by performing oropharyngeal examination as follows: Results of oropharyngeal examination (Normal and abnormal); If abnormal, any signs of lesion on oral mucosa or irritation of oral mucosa.|Day 1 (at screening and end of study)|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Participants|||Number
58|NCT02822287|Secondary|Number of Participants With Overall Opinion of Oral Solution|Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.|1 hour post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Number of Participants|||Number
95|NCT02809833|Primary|VAS Score of Participant-Assessed Disease Activity at Baseline|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
59|NCT02822287|Secondary|Number of Participants With Overall Opinion of Warming Sensation|Overall opinion of warming sensation was measured by scale: 9= Like extremely; 8= Like very much; 7= Like moderately; 6= Like slightly; 5= Neither like nor dislike; 4= Dislike slightly; 3= Dislike moderately; 2= Dislike very much; 1= Dislike extremely|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Number of Participants|||Number
60|NCT02822287|Secondary|Number of Participants With Acceptability of Warming Sensation|Acceptability of strength of warming sensation was measured by a scale: 5= Much too strong; 4=Too strong (too warming); 3= Just about right (pleasant warming); 2= Too weak (not warming enough); 1= Much too weak|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Number of Participants|||Number
61|NCT02822287|Primary|Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose|Warming Sensation Intensity was measured on 100 mm visual analogue scale (VAS), marked as “no warming sensation” on the left hand side (= 0 mm) and “strongest possible warming sensation” at the right hand side (=100 mm) at pre-dose.|Pre-dose and 60 sec post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Millimeters (mm)||Standard Deviation|Mean
62|NCT02822287|Primary|Duration of Warming Sensation|Duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset of warming sensation occurred within 10 minutes of dosing but had not ended by the end of 10 minutes following dosing, then the duration was censored at 10 minutes minus the time to onset|10 minutes post-dose|The safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint and safety analysis. Of the 57 subjects in the Safety Population, 53 reported an onset of a warming sensation within10 minutes after dosing.||Minutes||Full Range|Median
63|NCT02822287|Primary|Onset of Warming Sensation|Onset and duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset had not occurred by 10 minutes then time to onset was censored at 10 minutes. 53 of the 57 participants had onset within 10 minutes after dosing.|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.||Minutes||Full Range|Median
64|NCT02809911|Primary|Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). 16 tests favored Sham. 4 tests favored Provant.|4 weeks|Includes subjects in the Initial Treatment Group (Those subjects treated with either Provant or Sham at the Enrollment Visit)||Number of tests favoring arm/group|||Number
65|NCT02809911|Primary|Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). 6 tests favored Sham. 14 tests favored Provant.|4 weeks|Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.||Number of tests favoring arm/group|||Number
66|NCT02809833|Secondary|Percentage of Participants With AEs Considered Causally Related to Tocilizumab|"An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of tocilizumab. Worsened pre-existing conditions and laboratory or clinical tests that resulted in change or discontinuation of treatment were reported as AEs. The percentage of participants with treatment-related AEs (also known as adverse drug reactions) was reported as a separate endpoint and included both serious and non-serious AEs. Those AEs with a causal relationship reported as definite, probably, possible, or unlikely were considered to be related to tocilizumab. If the causal relationship was reported as unrelated, the AE was considered not related to tocilizumab treatment. Terms were reported verbatim as coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 12.0. The most common treatment-related AEs were reported, using those from the 10 highest incidence rate levels."|Baseline to end of treatment (up to 12 months)|All Enrolled Population||percentage of participants|||Number
338|NCT02717754|Secondary|Cmax of Oseltamivir and RO0640802|Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.||ng/mL||Standard Deviation|Mean
67|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 52.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
68|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 36.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
69|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 24.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
70|NCT02809833|Primary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 12.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
71|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
72|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
73|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
74|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
75|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
76|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
77|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
78|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
79|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
80|NCT02809833|Primary|Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
81|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 52|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 52 visit and the DAS28 change from Baseline to Week 52. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
82|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 36|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 36 visit and the DAS28 change from Baseline to Week 36. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
83|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 24|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 24 visit and the DAS28 change from Baseline to Week 24. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
84|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 12|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 12 visit and the DAS28 change from Baseline to Week 12. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
85|NCT02809833|Primary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 4 visit and the DAS28 change from Baseline to Week 4. Participants with a score less than or equal to (≤) 3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
86|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
87|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
88|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
89|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
90|NCT02809833|Primary|VAS Score of Physician-Assessed Disease Activity at Baseline|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
91|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
92|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
93|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
94|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||mm||Standard Deviation|Mean
465|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)|ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up||dB||Standard Error|Mean
96|NCT02809833|Primary|Change in SJC From Baseline to Week 52|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
97|NCT02809833|Primary|Change in SJC From Baseline to Week 36|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
98|NCT02809833|Primary|Change in SJC From Baseline to Week 24|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
99|NCT02809833|Primary|Change in SJC From Baseline to Week 12|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
100|NCT02809833|Primary|SJC at Baseline|A total of 28 joints were assessed for swollenness. The number of swollen joints at Baseline was reported and could range from 0 to 28, where higher values represented more swollen joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||swollen joints||Standard Deviation|Mean
101|NCT02809833|Primary|Change in TJC From Baseline to Week 52|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
102|NCT02809833|Primary|Change in TJC From Baseline to Week 36|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
103|NCT02809833|Primary|Change in TJC From Baseline to Week 24|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
104|NCT02809833|Primary|Change in TJC From Baseline to Week 12|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
105|NCT02809833|Primary|TJC at Baseline|A total of 28 joints were assessed for tenderness. The number of tender joints at Baseline was reported and could range from 0 to 28, where higher values represented more tender joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||tender joints||Standard Deviation|Mean
106|NCT02809833|Primary|Change in DAS28 From Baseline to Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
107|NCT02809833|Primary|Change in DAS28 From Baseline to Week 48|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 48 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
190|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) in Factor VII Activity|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.||kIU/L||Full Range|Mean
4456|NCT02259400|Secondary|Intraventricular Hemorrhage (IVH)||1 month of life|||participants|||Number
108|NCT02809833|Primary|Change in DAS28 From Baseline to Week 44|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 44 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
109|NCT02809833|Primary|Change in DAS28 From Baseline to Week 40|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 40 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
110|NCT02809833|Primary|Change in DAS28 From Baseline to Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
111|NCT02809833|Primary|Change in DAS28 From Baseline to Week 32|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 32 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
112|NCT02809833|Primary|Change in DAS28 From Baseline to Week 28|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 28 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
113|NCT02809833|Primary|Change in DAS28 From Baseline to Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
114|NCT02809833|Primary|Change in DAS28 From Baseline to Week 20|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 20 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
115|NCT02809833|Primary|Change in DAS28 From Baseline to Week 16|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 16 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
220|NCT02755805|Secondary|Differences in Apathy Symptoms Between Groups Over Time|"Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models.~The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point."|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
116|NCT02809833|Primary|Change in DAS28 From Baseline to Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
117|NCT02809833|Primary|Change in DAS28 From Baseline to Week 8|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 8 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
118|NCT02809833|Primary|Change in DAS28 From Baseline to Week 4|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 4 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
119|NCT02809833|Primary|28-Joint Disease Activity Score (DAS28) at Baseline|The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||units on a scale||Standard Deviation|Mean
120|NCT02809833|Primary|Percentage of Participants With Tocilizumab Dose Adjustments by Reason|"The percentage of participants with any tocilizumab dose adjustment during the study was reported among all reasons given for tocilizumab dose adjustments, as provided in the CRF. The sum of all reasons may add up to >100 percent (%) because more than one reason could be given for each dose change. In the table presented, Other Reasons refers to any reason other than those specified in categories. Similarly, Other Laboratory Change refers to a change in any laboratory parameter other than those specified in categories."|Baseline to end of treatment (up to 12 months)|"All Enrolled Population. The Number of Participants Analyzed reflects the number of participants who had at least one tocilizumab dose adjustment during the study."||percentage of participants|||Number
121|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 52."|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
122|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 48."|Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
147|NCT02806505|Secondary|Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)|Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.|EOT (Week 48)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
4457|NCT02259400|Secondary|Pneumothorax (PNX)||10 days|||participants|||Number
123|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 44."|Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
124|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 40."|Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
125|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 36."|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
126|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 32."|Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
127|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 28."|Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
128|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 24."|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
689|NCT02614924|Primary|Total Time Taken to Complete the Procedure of Awake Intubation||up to 20 minutes|||seconds||Inter-Quartile Range|Median
129|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 20."|Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
130|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 16."|Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
131|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 12."|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
132|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 8."|Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
133|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values greater than (>) 1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC less than (<) 0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 4."|Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."||percentage of participants|||Number
134|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 52|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 52 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
189|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in Factor VII Activity (Tmax)|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.||hours||Full Range|Median
135|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 24|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 24 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percentage of participants|||Number
136|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Baseline|SmPC recommendations were specified in the collection of routine laboratory samples for alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), absolute neutrophil count (ANC), and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific upper limit of normal (ULN). Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells per liter (cells/L) for ANC and 50 to 100 × 10^3 cells per microliter (cells/μL) for platelet count. The percentage of participants with greater than or equal to (≥) 1 documented/evaluable laboratory value at Baseline was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Baseline|All Enrolled Population.||percentage of participants|||Number
137|NCT02808130|Primary|Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status|Contrary to oxidant mediators, TAOC provides an extensive overview of the antioxidant status of the individuals and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of TAOC can provide a more accurate and extensive assessment of antioxidant status rather than the separate measurement of individual antioxidant molecules|8-10 am on the day following periodontal status assessment.|||pg/ml||Standard Error|Mean
138|NCT02808130|Primary|Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation|Protein carbonylation is another nonenzymatic oxidative post-translational modification and assesed by protein carbonyl tissue content that is often used as a biomarker of oxidative stress.|8-10 am on the day following periodontal status assessment.|||pg/ml||Standard Error|Mean
139|NCT02808130|Primary|Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.|Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipid. Malondialdehyde (MDA) is the most specific and the most often used molecule in the measurement of biological lipid oxidation|8-10 am on the day following periodontal status assessment.|||pg/ml||Standard Error|Mean
140|NCT02806544|Secondary|Breast Conserving Therapy|"The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)."|4-6 months|This outcome measure was analyzed in patients who were treated with 4 months of neoadjuvant tamoxifen||participants|||Number
141|NCT02806544|Secondary|Pathologic Complete Response|Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.|4-6 months|This Outcome Measure was only assessed among patients who had undergone surgery.||participants|||Number
142|NCT02806544|Secondary|Overall Clinical Response Rate|Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.|4-6 months|This Outcome Measure was only assessed among patients undergoing surgery and is a unique outcome measure.||participants|||Number
143|NCT02806544|Secondary|Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy|Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.|4-6 weeks|32 of the 35 patients underwent an on-treatment biopsy; 3 patients did not follow-up and were not included in the number of participants analyzed for this measure.||participants|||Number
144|NCT02806544|Secondary|Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen|"Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)"|4-6 months|||participants|||Number
145|NCT02806544|Primary|Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility|Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.|4-6 months|The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study.||participants|||Number
146|NCT02806505|Secondary|Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24|Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.|Weeks 12 and 24|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
486|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
148|NCT02806505|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment|SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.|24 weeks after end of treatment (Week 72)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
149|NCT02796092|Secondary|Need for Re-embolization|Scheduled re-embolization due to incomplete occlusion|12 months|||participants|||Number
150|NCT02796092|Secondary|Complications|Toral number of events related to the procedure in the follow-up (1 year)|12 months|||events|||Number
151|NCT02796092|Secondary|Complications|Total number of events during the procedure|intraoperative|||minor events|||Number
152|NCT02796092|Secondary|Procedure Radiation Dose (AK)|AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment|Intraoperative|||mGy||Standard Deviation|Mean
153|NCT02796092|Secondary|Procedure Radiation Dose (DAP)|DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment|Intraoperative|||mGy*cm^2||Standard Deviation|Mean
154|NCT02796092|Secondary|Fluoroscopy Time|Total fluoroscopy time, recorded by the equipment (in minutes)|Intraoperative|||minutes||Standard Deviation|Mean
155|NCT02796092|Secondary|Total Intervention Duration|Total time length of the procedure, from puncture to compression (in minutes)|Intraoperative|||minutes||Standard Deviation|Mean
156|NCT02796092|Secondary|Cost of Treatment|Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.|Intraoperative|||US Dollars||Standard Deviation|Mean
157|NCT02796092|Secondary|Number of Devices Used|Number of coils and number of vascular plugs used in each procedure|intraoperative|||devices||Standard Deviation|Mean
158|NCT02796092|Secondary|Satisfaction With the Procedure|"Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9).~Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem."|12 months|||units on a scale||Standard Deviation|Mean
159|NCT02796092|Secondary|Improvement of Dysmenorrhea|Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dysmenorrhea||participants|||Number
160|NCT02796092|Secondary|Improvement of Urinary Urgency|Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment urinary urgency||participants|||Number
161|NCT02796092|Secondary|Improvement of Dyspareunia|Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dyspareunia||participants|||Number
162|NCT02796092|Primary|Change in Pain Scale|"Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9).~VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)"|12 months|Population presenting pre-treatment pain (more than 1 in VAS)||participants|||Number
163|NCT02792049|Secondary|Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)|Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM.|Within 10 minutes of study completion|||participants|||Number
164|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation|Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use).|Within 10 minutes of study completion|||Units on a scale||Inter-Quartile Range|Median
165|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Better Seal Formation|Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation).|Within 10 minutes of study completion|||Units on a scale||Inter-Quartile Range|Median
166|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Ease of Use|Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5).|Within 10 minutes of study completion|||Units on a scale||Inter-Quartile Range|Median
167|NCT02792049|Primary|Mean Received Tidal Volume|Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters|3 minutes|||milliliters||Standard Deviation|Mean
168|NCT02791269|Secondary|Number of Participants With HBeAg Seroconversion|HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Only HBeAg positive participants was planned to be reported. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
169|NCT02791269|Secondary|Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level|ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
487|NCT02663232|Secondary|Median Time Since Diagnosis of Melanoma|Median time from the diagnosis of primary melanoma to advanced disease was determined in years.|Day 1|All participants enrolled in the study were included in the analysis except for one participant with missing data.||years||Full Range|Median
170|NCT02791269|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
171|NCT02791269|Secondary|Number of Participants With HBV-DNA <400 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."||participants|||Number
172|NCT02791269|Primary|Number of Participants With HBV-DNA <20,000 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|End of 24-weeks follow-up (Week 72)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||participants|||Number
173|NCT02791269|Primary|Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)|HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.|End of 24-weeks follow-up (Week 72)|"Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had one subsequent post baseline assessment. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||participants|||Number
174|NCT02788097|Primary|Biochemical Pregnancy|>30IU/L of serum βhCG on day 14 of cycle|1 year|||percentage of participants|||Number
175|NCT02780622|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 26|All enrolled participants.||percentage of participants|||Number
176|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL/mg||Standard Deviation|Mean
177|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL||Standard Deviation|Mean
178|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL/mg||Standard Deviation|Mean
179|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 and 24 hours post-dose on Day 5|All enrolled participants.||h*ng/mL||Standard Deviation|Mean
180|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the Cmax values (nanograms per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||Nanogram/milliliter/milligram (ng/mL/mg)||Standard Deviation|Mean
181|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
182|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||liters per hour (L/h)||Standard Deviation|Mean
183|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for Oseltamivir||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||liters per hour (L/h)||Standard Deviation|Mean
184|NCT02780622|Secondary|Terminal Half-life (t½) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||hours||Standard Deviation|Mean
185|NCT02780622|Secondary|Terminal Half-life (t½) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||hours||Standard Deviation|Mean
186|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.||hours||Full Range|Median
187|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.||hours||Full Range|Median
188|NCT02780622|Primary|Change From Baseline in Plasma Concentration of Vitamin K1|Vitamin K1 is required by proteins involved in blood clotting. Food interaction with warfarin can lead to decreases in Vitamin K1 in plasma. An increase in vitamin K1 signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1 and 24 hours post-dose on Day 5|All enrolled participants.||nanogram per liter (ng/L)||Full Range|Mean
488|NCT02663232|Secondary|Percentage of Participants Categorized By LDH Level|Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
6049|NCT02179398|Secondary|Hospitalization Rate||at PED presentation|||participants|||Number
191|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for Factor VII Activity|Factor VIIa is a protein that causes blood to clot, and low levels in the blood can cause excessive or prolonged bleeding after an injury or surgery. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.||hours*kIU/L||Full Range|Mean
192|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in International Normalized Ratio (INR) (Tmax)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.||hours||Full Range|Median
193|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) of International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.||ratio||Full Range|Mean
194|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.||hours*ratio||Full Range|Mean
195|NCT02774278|Secondary|Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST|Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.||percentage of participants||95% Confidence Interval|Number
196|NCT02774278|Secondary|Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.||percentage of participants||95% Confidence Interval|Number
197|NCT02774278|Primary|Number of KRAS Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had KRAS mutation at baseline were included in this analysis.||participants|||Number
198|NCT02774278|Primary|Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had EGFR mutation at baseline were included in this analysis.||participants|||Number
221|NCT02755805|Secondary|Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)|"Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models.~The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
199|NCT02774278|Primary|Number of Differentially Expressed Genes Associated With Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Primary analysis set (PAS) included all participants who provided evaluable tissue samples and were included in the primary Affymetrix efficacy analysis.||genes|||Number
200|NCT02773758|Secondary|Change From Baseline in Tactile Threshold at Day 7 and Day 14|A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.|Baseline, Day 7 and Day 14|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.||gram (g)||Standard Deviation|Mean
201|NCT02773758|Secondary|Change From Baseline in Schiff Sensitivity Score at Day 7|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant’s response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 7|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
202|NCT02773758|Primary|Change From Baseline in Schiff Sensitivity Score at Day 14|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant’s response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 14|Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.||score on a scale||Standard Deviation|Mean
203|NCT02772666|Primary|Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)|"The instrument illuminated the eyes alternatively and took images and recorded pupillary reflex to this light stimulation.~All of 44 patients were examined with two methods, SFT and O Glass. SFT method: The well known manual method to diagnose RAPD. O glass method:The device consists of camera and light sources.The red light was on and off for a 5 second interval. Then the white light was on for right eye and 3 seconds later the system captured an image. After 0.5 second the right light was off and the left light turned on, 3 seconds later the image was captured. The images were processed and analyzed using computerized software."|up to 6 months|||participants|||Number
204|NCT02766400|Primary|Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time.~The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses."|Baseline, rehab discharge, month 3, month 6, month 12|||units on a scale||Standard Error|Mean
205|NCT02766244|Primary|Perfusion of Burned Area|Perfusion as measured by ICG Fluorescence|5 days|||% perfusion compared to normal skin|||Number
206|NCT02765269|Secondary|Karnofsky Performance Score Evaluation|"The Karnofsky performance score runs from 100 to 0, where 100 is perfect health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group."|2 weeks|||scores on a scale||Standard Deviation|Mean
207|NCT02765269|Secondary|Users' Satisfaction (Questionnaire)|Patients will be asked to complete a questionnaire after patients use it for 2 weeks.|2 weeks|||participants|||Number
208|NCT02765269|Secondary|Pain Management|"Numerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where 0 means no pain and 10 means pain as bad as it could be. Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period."|2 weeks|||scores on a scale||Standard Deviation|Mean
209|NCT02765269|Primary|Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients|The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.|2 weeks|||pain assessments per day||Standard Deviation|Mean
311|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 24 Months|A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).|24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
210|NCT02761629|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories|ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), >1-2 Upper Normal Limit (ULN), >2-5 ULN, >5-10 ULN, and >10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96|Safety analysis population: all randomized participants who receive >/=1 dose of any study medication and had >/=1 post-baseline safety assessment. Number of participants analyzed= overall participants who were evaluable for this outcome at any time-point and “n” = participants who were evaluable at specified time-point; for each arm, respectively.||percentage of participants|||Number
211|NCT02761629|Secondary|Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."||Ratio||Standard Deviation|Mean
212|NCT02761629|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
213|NCT02761629|Secondary|Serum Human Immunodeficiency Virus (HIV) RNA Levels|HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants with detectable HIV RNA levels and n = participants with detectable HIV RNA levels at specified time-point; for each arm, respectively."||Log10 copies per milliliter||Standard Deviation|Mean
214|NCT02761629|Secondary|Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment|SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm).|24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|ITT analysis population. Here, number of participants analyzed signifies participants with undetectable HCV RNA at the end of treatment.||percentage of participants|||Number
215|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders.|12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 84 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|ITT analysis population||percentage of participants||95% Confidence Interval|Number
216|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for ‘Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks’ arm and Week 72 for ‘Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks’ arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, and 48; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, and 72|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for this outcome at specified time-point; for each arm, respectively."||percentage of participants||95% Confidence Interval|Number
217|NCT02761629|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter [IU/mL]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.|24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|Intent-to-treat (ITT) analysis population||percentage of participants||95% Confidence Interval|Number
218|NCT02756351|Secondary|Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study.||18 hours|||Adverse Events|||Number
219|NCT02756351|Primary|Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.||18 hours|||fold change in log value||Standard Deviation|Mean
312|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 12 Ponths|A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.|12 months|Full Analysis Set (all enrolled participants)||percentage of participants||95% Confidence Interval|Number
222|NCT02755805|Secondary|Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)|"Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models.~The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
223|NCT02755805|Primary|Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models.~The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point."|Baseline, rehabilitation discharge, month 3, month 6|||units on a scale||Standard Error|Mean
224|NCT02753699|Secondary|Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.|Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.|at Week 48|Full analysis set. In the categories, n is the number of subjects in FAS in the appropriate study group with normal ALT at visit; for Overall - at all available visits.||percentage of participants|||Number
225|NCT02753699|Primary|Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48||up to 120 Weeks|Full analysis set (FAS), defined as all participants who enrolled into this study and had at least one HCV RNA assessment, unless excluded due to protocol deviations.||percentage of participants|||Number
226|NCT02750943|Secondary|Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12|Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood ‘Present’ (Trace or Substantial) or ‘absent’ in expectorate was analyzed.|Week 4, Week 12|Analysis for this outcome was conducted on ITT population which included all the participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.||number of participants|||Number
227|NCT02750943|Secondary|Modified Gingival Index (MGI) at Week 4 and Week 12|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.|Week 4, Week 12|Analysis for this outcome was conducted on ITT population which included all the participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. n= number of participants analyzed for this outcome.||unit on score||Standard Error|Least Squares Mean
228|NCT02750943|Secondary|Bleeding Index (BI) at Week 4 and Week 12|BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Week 4, Week 12|Analysis for this outcome was conducted on ITT population which included all the participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. n= number of participants analyzed for this outcome.||unit on score||Standard Error|Least Squares Mean
229|NCT02750943|Secondary|Number of Bleeding Sites at Week 4|Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 4|Analysis for this outcome was conducted on ITT population which included all the participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.||number of bleeding sites||Standard Error|Least Squares Mean
230|NCT02750943|Primary|Number of Bleeding Sites at Week 12|Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 12|Analysis for this outcome was conducted on intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.||number of bleeding sites||Standard Error|Least Squares Mean
337|NCT02717754|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802|Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||hour||Standard Deviation|Mean
231|NCT02750709|Secondary|Apparent Terminal Half-life (t1/2)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Geometric Coefficient of Variation|Geometric Mean
232|NCT02750709|Secondary|Terminal Elimination Rate Constant (λz)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||1/hr||Geometric Coefficient of Variation|Geometric Mean
233|NCT02750709|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Full Range|Median
234|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
235|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 72 Hours Post-dose (AUC(0-72))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
236|NCT02750709|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 120 Hours Post-dose (AUC(0-120))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
237|NCT02750709|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
238|NCT02750345|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.||hr||Geometric Coefficient of Variation|Geometric Mean
239|NCT02750345|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study||1/hr||Geometric Coefficient of Variation|Geometric Mean
240|NCT02750345|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical analysis for the study.||hr||Full Range|Median
241|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
242|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods must be the reference product), and who had no major protocol deviations thought to impact on the analysis of the pk data were included in the statistical pk analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
243|NCT02750345|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary Pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment includes the reference product), and who had no major protocol deviations thought to impact the analysis of the pk data were included for the statistical pk analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
244|NCT02750345|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least two treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1854|NCT02462291|Secondary|Systolic Blood Pressure (mmHg)|Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment|||(mmHg)||Standard Deviation|Mean
245|NCT02750332|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Geometric Coefficient of Variation|Geometric Mean
246|NCT02750332|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||1/hr||Geometric Coefficient of Variation|Geometric Mean
247|NCT02750332|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr||Full Range|Median
248|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
249|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
250|NCT02750332|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
251|NCT02750332|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
252|NCT02748213|Secondary|Duration of Response (DOR) According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|"FAS Population. The Number of Participants Analyzed reflects the number of participants with a best overall response of CR or PR who provided evaluable data for the analysis."||months||Full Range|Median
253|NCT02748213|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.||months||95% Confidence Interval|Median
254|NCT02748213|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.||percentage of participants|||Number
255|NCT02748213|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.||months||95% Confidence Interval|Median
256|NCT02748213|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.||percentage of participants|||Number
324|NCT02731131|Secondary|Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.|Week 48|ITT Population.||participants|||Number
257|NCT02748213|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|Full Analysis Set (FAS) Population.||percentage of participants||95% Confidence Interval|Number
258|NCT02746679|Secondary|The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
259|NCT02746679|Secondary|The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
260|NCT02746679|Secondary|The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
261|NCT02746679|Secondary|The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
262|NCT02746679|Secondary|The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
263|NCT02746679|Secondary|The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
264|NCT02746679|Secondary|The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
265|NCT02746679|Secondary|The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks|||units on a scale(t scores)||Standard Deviation|Mean
685|NCT02615717|Secondary|Patient Health Questionnaire (PHQ-9)|Self-report measure of 9 symptoms related to depression Range: 0-27, all items summed Higher score indicates higher severity|within three days|||units on a scale||Standard Deviation|Mean
266|NCT02746679|Secondary|The Zung Self-Rating Depression Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).|Baseline and 8 weeks|||units on a scale(raw scores)||Standard Deviation|Mean
267|NCT02746679|Secondary|Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery||3 months|||participants|||Number
268|NCT02746679|Secondary|Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation||3 months|||units on a scale||Standard Deviation|Mean
269|NCT02746679|Secondary|Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.||3 months|||mm||Standard Deviation|Mean
270|NCT02746679|Primary|The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).|Baseline and 8 weeks|||units on a scale(raw scores)||Standard Deviation|Mean
271|NCT02746406|Primary|Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.|Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group|Through study completion, an average of 4 days|||participants|||Number
272|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score|The proportion of OAC prescription for the range 1-5 of CHA2D2s-VASC scores. CHA2D2S-VASC risk score ranges from 1-5, with higher scores indicating a greater risk of stroke.|5 min|||participants|||Number
273|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)|the participant physicians were randomized to prescribe to virtual patients or to imagine that the risk seen in the diagram was that of themselves|5 min|||participants|||Number
274|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)|the proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years|5 minutes|||participants|||Number
275|NCT02746107|Primary|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams|after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment|after seeing the decision aid (5 min)|||participants|||Number
276|NCT02743936|Secondary|Patient Discomfort (Verbal Numerical Rating Scale)|Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)|After study completion (approximately 2 minutes after study start)|||Scores on verbal numerical rating scale||Inter-Quartile Range|Median
277|NCT02743936|Primary|Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine|Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine|2 minutes after mask placement|||Liters per minute||Inter-Quartile Range|Median
278|NCT02743702|Primary|Change From Baseline Vital Capacity at One Year.|Change from Baseline vital capacity at one year evaluated by spirometer.|At baseline and at 1 year|||percentage of Change of vital capacity||Inter-Quartile Range|Median
279|NCT02739594|Secondary|Percent Change From Baseline in CrCl|CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as [Week 44 or 92 CrCl minus Baseline CrCl] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who provided data within the specified timeframe for each analysis (n) is shown in the table."||percent change||Standard Deviation|Mean
280|NCT02739594|Secondary|Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline|Elevation in SCr was defined as an increase greater than (>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (<) 1.4 mg/dL, or an increase >1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.|Baseline and Weeks 44, 92|ITT Population.||percentage of participants||95% Confidence Interval|Number
281|NCT02739594|Secondary|Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)|The percent change in GGT was calculated as [Week 44 or 92 GGT minus Baseline GGT] divided by Baseline GGT, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percent change||Full Range|Median
282|NCT02739594|Secondary|Percent Change From Baseline in Alpha (A) 1-Microglobulin|The percent change in A1-microglobulin was calculated as [Week 44 or 92 A1-microglobulin minus Baseline A1-microglobulin] divided by Baseline A1-microglobulin, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percent change||Full Range|Median
283|NCT02739594|Secondary|Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)|The percent change in B-NAG was calculated as [Week 44 or 92 B-NAG minus Baseline B-NAG] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."||percent change||Full Range|Median
284|NCT02739594|Secondary|Number of Zoledronate Dose Reductions for Each Participant|The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.||dose reductions||Standard Deviation|Mean
285|NCT02739594|Secondary|Percentage of Participants With Zoledronate Dose Reduction|The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.||percentage of participants||95% Confidence Interval|Number
286|NCT02739594|Secondary|Number of Events of Osteonecrosis of Jaw for Each Participant|The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.|From Baseline to end of study (up to Week 96)|ITT Population.||events of osteonecrosis of jaw||Standard Deviation|Mean
287|NCT02739594|Secondary|Percentage of Participants With Osteonecrosis of Jaw|The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.||percentage of participants||95% Confidence Interval|Number
288|NCT02739594|Secondary|Number of SREs for Each Participant|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.|From Baseline to end of study (up to Week 96)|ITT Population.||SREs||Standard Deviation|Mean
289|NCT02739594|Secondary|Time to First SRE|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. Time to first SRE was defined as the time from first dose of study drug to the time of SRE during the study. The median time to first SRE was estimated by Kaplan-Meier analysis and expressed in days.|From Baseline to end of study (up to Week 96)|ITT Population.||days||Full Range|Median
290|NCT02739594|Secondary|Percentage of Participants With Skeletal-Related Events (SREs)|SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.||percentage of participants||95% Confidence Interval|Number
291|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported.|Baseline, Week 92|ITT Population.||percentage of participants||95% Confidence Interval|Number
292|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.|Baseline, Week 44|Intent-to-Treat (ITT) Population.||percentage of participants||95% Confidence Interval|Number
293|NCT02736721|Primary|Time to Loss of Previous MR|Time to loss of previous MR was defined as the interval between the first day of treatment in the study and the first day of loss of previous MR. MR was assessed using BCR-ABL transcript levels measured by RT-PCR from peripheral blood.|Up to approximately 7 years|Analysis population included all enrolled participants.||years||95% Confidence Interval|Median
294|NCT02736721|Primary|Number of Participants With Molecular Response (MR)|MR was assessed using breakpoint cluster region - Abelson (BCR-ABL) proto-oncogene transcript levels measured by RT-PCR from peripheral blood. Number of participants with BCR-ABL/ABL ratio less than or equal to 10 (%) was reported.|Up to approximately 7 years|Analysis population included all enrolled participants.||participants|||Number
295|NCT02736721|Primary|Time to Loss of Previous CyR|Time to loss of previous CyR was defined as the interval between the first day of treatment in the study and the first day of loss of previous CyR. CyR is based on the prevalence of Ph+ bone marrow cells in metaphase. Major CyR was categorized as either CCyR or PCyR. CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34% of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.||years||95% Confidence Interval|Median
335|NCT02717754|Secondary|Volume of Distribution (Vd) of Oseltamivir and RO0640802|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||Liter||Standard Deviation|Mean
296|NCT02736721|Primary|Number of Participants With Major Cytogenetic Response (CyR)|CyR was based on the prevalence of Philadelphia chromosome-positive (Ph+) bone marrow cells in metaphase determined from reverse transcriptase polymerase chain reaction (RT-PCR). Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34 percent (%) of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.||participants|||Number
297|NCT02736721|Primary|Time to Loss of Previous Hematologic Response|Time to loss of previous hematologic response was defined as the interval between the first day of treatment in the study and the first day of loss of previous hematologic response during elapsed time of study. Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to <10*10^9/L with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.||months||95% Confidence Interval|Median
298|NCT02736721|Primary|Number of Participants With Complete Hematologic Response|Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to less than (<) 10*10^9 per liter (/L) with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.||participants|||Number
299|NCT02732639|Secondary|Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72|Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
300|NCT02732639|Secondary|Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72|Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
301|NCT02732639|Secondary|Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels|Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.|At Screening and at Weeks 48 and 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||participants|||Number
302|NCT02732639|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72|Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
303|NCT02732639|Secondary|Percentage of Participants With Negative HDV RNA at Week 48|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
304|NCT02732639|Secondary|Percentage of Participants With Normal ALT at Week 48|Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
305|NCT02732639|Primary|Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
306|NCT02732639|Primary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72|Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.||percentage of participants||95% Confidence Interval|Number
307|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 24 Months|Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.|24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
308|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 12 Months|Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.|12 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
309|NCT02732210|Secondary|Number of Prolia® Injections Received|The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.|24 months|Full analysis set||prolia injections||Inter-Quartile Range|Median
310|NCT02732210|Secondary|Time to Non-persistence|For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).|24 months|Full analysis set with non-persistence at 24 months||months||Inter-Quartile Range|Median
313|NCT02731313|Secondary|Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The weighted kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by IHC 4B5 and SISH. The weighted kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens' population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of specimens with available data for this outcome measure.||weighted kappa coefficient|Participants|95% Confidence Interval|Number
314|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages|The TNM stage system includes information about the size of the primary tumor (T), whether the cancer has spread to nearby lymph nodes (N) and whether the cancer has metastasized to other parts of the body (M). In the T classification TX indicates that the main tumor cannot be measured, T1, T2, T3 and T4 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. In the N classification NX indicates that the cancer in nearby lymph nodes cannot be measured, N0 indicates that there is no cancer in nearby lymph nodes, N1, N2 and N3 refer to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. In the M classification MX indicates that the metastasis cannot be measured, M0 indicates that the cancer has not spread to other parts of the body and M1 indicates that the cancer has spread to other parts of the body.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.||percentage of participants|||Number
315|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed|The Lauren classification is based on examination of histologic specimens under the microscope and divides adenocarcinoma of the stomach into 3 types: 1) Diffuse type: tumor cells are poorly differentiated, behave aggressively and tend to scatter throughout the stomach (rather than form glands). This type metastasizes to other parts of the body much quicker than intestinal type tumors, 2) Intestinal type: tumor cells are well differentiated, grow slowly and tend to form glands, 3) Mixed type: this type is made up of both intestinal and diffuse types.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.||percentage of participants|||Number
316|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location||At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.||percentage of participants|||Number
317|NCT02731313|Primary|Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using the pathologist’s choice of IHC and ISH techniques in local laboratories, and using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by local and centralized laboratories. The kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens’ population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion.||kappa coefficient|Participants|95% Confidence Interval|Number
318|NCT02731300|Secondary|Number of Epileptic Discharge After Treatment by tDCS||Baseline, 4 Weeks|||epileptic discharges/30 mins||Standard Deviation|Mean
319|NCT02731300|Primary|Number of Seizure After Treatment by tDCS||Baseline, 4 Weeks|||seizures||Standard Deviation|Mean
320|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.|Week 48|ITT Population.||participants|||Number
321|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.|Week 96|ITT Population.||participants|||Number
322|NCT02731131|Secondary|Number of Participants With ALT Normalization at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.|Week 48|ITT Population.||participants|||Number
323|NCT02731131|Secondary|Number of Participants With ALT Normalization at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.|Week 96|ITT Population.||participants|||Number
686|NCT02615717|Secondary|PTSD Checklist (PCL-5)|Self-report of PTSD symptom severity Scale range: 0-80 Total score utilized, all items summed. Higher score indicates higher severity.|within three days|||units on a scale||Standard Deviation|Mean
325|NCT02731131|Primary|Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.|Week 96|ITT Population.||participants|||Number
326|NCT02730260|Primary|Smoking Abstinence for 7 Days at Last Contact|By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.|6-12 months|These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.||participants|||Number
327|NCT02726022|Primary|Change From Baseline in SF-36 MCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
328|NCT02726022|Primary|Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
329|NCT02726022|Primary|Change From Baseline in SF-36 PCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
330|NCT02726022|Primary|Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
331|NCT02726022|Primary|Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
332|NCT02726022|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.||units on a scale||Standard Deviation|Mean
333|NCT02717754|Secondary|Minimum Plasma Concentration (Cmin) of RO0640802|Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5|PK analysis population. Only participants who received oseltamivir were analyzed.||ng/mL||Standard Deviation|Mean
334|NCT02717754|Secondary|Clearance (CL) of Oseltamivir and RO0640802|CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||Liters/hour||Standard Deviation|Mean
339|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||ng*hour/mL||Standard Deviation|Mean
340|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.||ng*hour/mL||Standard Deviation|Mean
341|NCT02717754|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State|Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.||ng/mL||Standard Deviation|Mean
342|NCT02717754|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State|AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed.||ng*hour/mL||Standard Deviation|Mean
343|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of GPT|Tmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||days||95% Confidence Interval|Median
344|NCT02716779|Secondary|Maximum Concentration (Cmax) of GPT|Cmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||U/L||95% Confidence Interval|Median
345|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT)||From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||(Units/liter)*day ([U/L]*d)||95% Confidence Interval|Median
346|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of PEG-IFN|Tmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||weeks||95% Confidence Interval|Median
347|NCT02716779|Secondary|Maximum Concentration (Cmax) of PEG-IFN|Cmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||ng/ml||95% Confidence Interval|Median
348|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of PEG-IFN|Evaluation of PEG-IFN arm after Day 0. Evaluation of ribavirin and placebo arms after Day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||(nanogram/milliliter)*day ([ng/ml]*d)||95% Confidence Interval|Median
349|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of Ribavirin|Tmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||weeks||95% Confidence Interval|Median
350|NCT02716779|Secondary|Maximum Concentration (Cmax) of Ribavirin|Cmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||mcg/ml||95% Confidence Interval|Median
351|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Ribavirin|Evaluation of ribavirin arm after Day 0. Evaluation of placebo and PEG-IFN arms after Day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.||(microgram/milliliter)*day ([mcg/ml]*d)||95% Confidence Interval|Median
363|NCT02708524|Primary|Comfort Each and Everyday Individual Item|Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
364|NCT02708524|Primary|Comfort at the End of the Day Individual Item|Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
352|NCT02716779|Secondary|Percentage of Participants With Treatment Response|HCV-RNA level was measured at each visit by a central laboratory. Treatment response was estimated applying the following definitions of response/non-response: 1) Adequate first phase decline: HCV RNA decline ≥ 0.5 log10 International Units/milliliter (IU/mL) from time 0 to 48 hours of PEG-IFN treatment (PEG-IFN arm: day 0 – day 2; placebo and ribavirin arm: day 42-day 44), 2) Rapid virologic response: HCV RNA < 15 IU/mL (=detection limit) on day 70, 3) Complete early virologic response: HCV RNA < 15 IU/mL on day 126, 4) Partial early virologic response (log decrease): HCV RNA decrease ≥ 2 log10 IU/mL from day 0 to day 126, 5) Partial early virologic response (cut off): HCV RNA <30000 IU/mL on day 126, 6) Non-response: HCV RNA decrease <2 log10 IU/mL from day 0 to day 126, 7) Null-response: HCV RNA decrease <1 log10 IU/mL from day 0 to day 28 and from day 0 to day 70 for PEG-IFN arm and placebo / ribavirin arm, respectively.|Up to Day 126|All evaluable participants of the Intent-to-Treat (ITT) population, who were documented for a total of 126 days of the treatment period.||percentage of participants|||Number
353|NCT02716779|Secondary|Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire|SF-36 is a psychometric scale to quantify health conditions. This psychometric scale has 8 dimensions of the subjective health status and consists of 36 individual items that have a varying number of related item scores (ranging from “yes/no” up to a 6-point scale). At first the raw scores were determined by summation over all items and weighted accordingly. Afterwards the raw scores were transformed to ranges of 0-100 with 100 being the highest level of health and compared to published reference scales. The following eight dimensions of subjective health conditions were considered: physical functioning index, role physical index, pain, general health perception, vitality, social functioning index, role emotional index and mental health index. The SF36 questionnaire had to be answered by the patients at screening before monotherapy, after monotherapy and at the end of the study (=end of combination therapy).|At screening (Days -56 to -1), at end of monotherapy (Week 6) and at end of combination therapy (Week 18)|Intent-to-treat (ITT) population includes all randomized participants who received at least one dose of study drug. Here, 'n' is the number of evaluable participants.||units on a scale||Standard Deviation|Mean
354|NCT02716779|Primary|Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action|To investigate possible action mechanisms, three different models were fitted to viruskinetic data and evaluated using related log-likelihood function values. These models were designed assuming individual effects with respect to infectiousness (model 1), virus production (model 2) or degradation of infected cells rate (model 3). The following viruskinetic parameters were fitted in each model: initial viral load, loss rate of infected cells (delta), effectivity of interferon with respect to a pharmacokinetic-pharmacodynamic model. A lower log likelihood function value indicates a lesser fit for the model.|Up to Day 126|Per Protocol (PP) population: participants with 6 weeks of monotherapy and at least 4 weeks combination therapy as well as three quantitative HCV-RNA measurements (baseline, period 1, period 2), no major protocol violations, no treatment interruption and no dose reduction below 80% of the planned medication within the first 10 therapy weeks.||log likelihood function value||95% Confidence Interval|Median
355|NCT02709577|Secondary|Absolute Weight Change||24 weeks or 52 weeks|||kg||Standard Deviation|Mean
356|NCT02709577|Primary|Change in HbA1c Values From Baseline Measurement|"Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline.~Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline."|Baseline to 24 weeks or 52 weeks|||percentage of HbA1c||Standard Deviation|Mean
357|NCT02708524|Secondary|Overall Opinion Individual Item|Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
358|NCT02708524|Secondary|Overall Quality of Vision Individual Item|Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
359|NCT02708524|Secondary|Subjective Overall Quality of Vision Composite Score|Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
360|NCT02708524|Primary|Making Your Eyes Feel Moist Throughout the Day Individual Item|Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
361|NCT02708524|Primary|Frequency of Experiencing Dryness Individual Item|Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
362|NCT02708524|Primary|Frequency of Lens Awareness Individual Item|Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
365|NCT02708524|Primary|Overall Comfort Individual Item|Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month follow-up|Subjects that completed all study visits without a major protocol deviation.||percentage of participants|||Number
366|NCT02708524|Primary|Subjective Overall Comfort Composite Score|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|All subjects that completed all study visits without a major protocol deviation.||average clue score||Standard Deviation|Mean
367|NCT02708277|Secondary|Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||Within the first 3 months after surgery|||participants|||Number
368|NCT02708277|Secondary|Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound||Within the first 3 months after surgery|||mm||Standard Deviation|Mean
369|NCT02708277|Secondary|Menstruation Pattern(Improvement or No Significant Change) of All Participants|Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients|Within the first 3 months after surgery|||participants|||Number
370|NCT02708277|Primary|Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||three years|||participants|||Number
371|NCT02708238|Secondary|Number of Responders|Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline|28 days of treatment|||number of responders|||Number
372|NCT02708238|Primary|Median Daily Crying Time at the End of the Treatment|Median daily crying at the end of treatment (day 28).|28 days of treatment|||minutes||Full Range|Median
373|NCT02708212|Secondary|Overall Duration of BDE Examinations|The overall duration of both EGD and colonoscopy examinations was recorded and compared.|On the day of bidirectional endoscopy|||minutes||Standard Deviation|Mean
374|NCT02708212|Primary|Sedative Doses of Midazolam|During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.|On the day of bidirectional endoscopy procedures|||mg/kg||Standard Deviation|Mean
375|NCT02708212|Primary|Sedative Doses of Fentanyl|During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.|On the day of endoscopic procedures.|||mcg/kg||Standard Deviation|Mean
376|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
377|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Deaths of All Causes||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
378|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
379|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
380|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Until 28 days from last dose of study treatment (Week 28)|mITT Population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
381|NCT02707640|Primary|Percentage of Participants With Early Treatment Discontinuations|Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
382|NCT02707640|Primary|Percentage of Participants With Dose Reductions|Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).||percentage of participants|||Number
393|NCT02694718|Secondary|Percentage of Participants With Sphincter-preservation|Percentage of participants with sphincter-preservation is reported.|Up to Week 16|ITT population included all participants, who received at least one dose of study drug. Two participants from the ITT population did not undergo surgery (one died, one withdrew consent).||Percentage of participants|||Number
426|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.||percentage of participants|||Number
383|NCT02701387|Primary|Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone|"Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows:~Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8)"|Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)|Seven participants, each missing at least two posterior teeth in the same arch, were enrolled, resulting in 10 matched pairs for analysis. Outcome was assessed per implant, not per individual participant;||units on a scale|implants|Standard Deviation|Mean
384|NCT02701270|Secondary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood insulin measurements were available.||min*mmol/L||Standard Deviation|Mean
385|NCT02701270|Primary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood glucose measurements were available.||min*mmol/L||Standard Deviation|Mean
386|NCT02699892|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant’s disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: (0.56*√TJC)+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28</=3.2; reduction of DAS28 >1.2.|Baseline, Weeks 24, 48 and 72|"ITT Population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point."||Percentage of participants|||Number
387|NCT02699892|Primary|Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion|DAS28 score is a measure of participant’s disease activity calculated using tender joint count [28 joints] (TJC28), swollen joint count [28 joints] (SJC28), participant’s global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: [0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of greater than (>) 3.2 to </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.|Baseline, 24 weeks after first rituximab infusion (Week 24)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||Percentage of participants|||Number
388|NCT02694718|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.||Participants|||Number
389|NCT02694718|Secondary|Percentage of Participants With Pathological Incomplete Tumor Response|Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.|Up to Week 16|ITT population included all participants, who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
390|NCT02694718|Secondary|Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes|Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).|From screening to Week 16|ITT population included all participants, who received at least one dose of study drug.||Percentage of participants|||Number
391|NCT02694718|Secondary|Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer|R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.|Up to Week 16|The ITT consists of all included participants, who received at least one dose of study drug. Five participants from ITT population with T4 rectal cancer underwent surgery.||Percentage of participants|||Number
392|NCT02694718|Secondary|Number of Participants With Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities is reported.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.||Participants|||Number
2095|NCT02441218|Secondary|Hospitalisation for Any Cause||From the date of randomisation to the date of first documented hospitalisation, up to 42 months|||participants|||Number
394|NCT02694718|Primary|Percentage of Participants With Pathological Complete Tumor Response|Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).|Up to Week 16|The intent to treat (ITT) population included all participants, who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
395|NCT02694536|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||months||95% Confidence Interval|Median
396|NCT02694536|Secondary|Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||percentage of participants|||Number
397|NCT02694536|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||months||95% Confidence Interval|Median
398|NCT02694536|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported to the nearest integer.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."||percentage of participants|||Number
399|NCT02694536|Secondary|European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores|"The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 (no/not at all) to 4 (very much) where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 (very poor) to 7 (excellent) where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available."|Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table."||units on a scale||Standard Deviation|Mean
400|NCT02694536|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.|Up to approximately 40 months (assessed continuously during treatment)|Safety Population||percentage of participants|||Number
401|NCT02694315|Primary|Bishop Score Prior to Induction of Labor|"median Bishop score assessed by digital vaginal examination as follows:~Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion.~Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more.~Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more.~Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft.~Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.~Note that a score more than 10 means patient is in labor not needing induction of labor."|72 hours|||units on a scale||Inter-Quartile Range|Median
402|NCT02694315|Primary|Cervical Length Prior to Labor Induction|median cervical length measured by transvaginal ultrasound in centimetres|24 hours|||centimetres||Inter-Quartile Range|Median
403|NCT02694198|Primary|Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion|Difference between women who expulsed the fetus within 24 hours and women who expulsed the fetus in more than 24 hours as regarding cervicovaginal fetal fibronectin level (ng/ml)|72 hours|||nanogram per milliliter||Standard Deviation|Mean
404|NCT02694198|Primary|Cervicovaginal Fetal Fibronectin Level|mean cervicovaginal fetal fibronectin level in women undergoing midtrimesteric induction of abortion|72 hours|Depending on Francesco et al., 2005 who found that Fetal fibronectin test positive in 19 among 270 (7.0%) women undergoing mid-trimester abortion. Assuming α=0.05 and confidence interval (CI)= 10.0% and by using PASS 11th release the minimal sample size is 120. With a possible 10% drop out of cases, the enrolled cases would be 135 cases.||nanogram per milliliter||Standard Deviation|Mean
405|NCT02693704|Primary|Listener's Subjective Preference|Listeners compare two audiovisual stimuli (diotic and spatialized) and Indicate their preference between binaural diotic (no spatialization), spatialized stimuli, or no preference. Results are given as the percentage of participant for the 3 possible answers in each group.|1 day of the experiment|||Percentage of participants|||Number
406|NCT02693704|Primary|Speaker's Localization|"Localization error (in number of spatial sectors)~For each group: average localization error over all subjects in the group. It is the difference between the actual spatial sector and the one reported by the listeners. There were 5 spatial sectors, and 9 possible locations. For instance: if the stimuli is played in sector 4, and the listener perceives it in 2, then the localization error is |4-2| = 2. The goal is to compare the localization error in 3 conditions: 1/ with no hearing aids (reference of natural localization) and no spatialization 2/ with hearing aids and standard fittings and no spatialization, and 3/ with spatialization applied."|1 day of the experiment|||Localization error (# spatial sectors)||Standard Deviation|Mean
407|NCT02693704|Primary|Speech Intelligibility|Speech recognition score (%) For each group: average of the SRS over all subjects in the group. The SRS correspond to the number of understood words in a sequence of sentences (French HINT database) mixed with several level of masking noise (speech-shaped noise). Some are played diotically, the other are spatialized in various directions. The goal is to ensure that the spatialization processing does not degrade the understanding of the speech.|1 day of the experiment|||Percentage of understood word||Standard Deviation|Mean
408|NCT02691416|Secondary|Montreal Cognitive Assessment (MoCA)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery|||units on a scale||Standard Deviation|Mean
409|NCT02691416|Secondary|Mini Mental State Examination (MMSE)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery|||units on a scale||Standard Deviation|Mean
410|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges|Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery|||number of nucleoplasmic bridges/1000 BN||Standard Deviation|Mean
411|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nuclear Buds|Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery|||number of nuclear buds/1000 BN cells||Standard Deviation|Mean
412|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography|Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.|before induction,after clamping removal ,operation ending ,1,3,7days post surgery|||ug/ml||Standard Deviation|Mean
413|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress:Micronuclei|Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery|||number of micronuclei/1000 BN cells||Standard Deviation|Mean
414|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA|Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation|before induction, after clamping removal,operation ending,1,3,7days post surgery|||pg/ml||Standard Deviation|Mean
415|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit|Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical|before induction,after clamping removal ,operation ending ,1,3,7days post surgery|||U/ml||Standard Deviation|Mean
416|NCT02687217|Secondary|Number of Patients Requiring Additional Treatment|Requirement of antipyretics; increased dose/ duration of antibiotic usage other than standard protocol; need for change to higher antibiotics; requirement of drainage procedures for pus/ wound infections; requirement for additional dressing sessions|14 days|||participants|||Number
417|NCT02687217|Secondary|Number of Patients Requiring Additional Investigations|Sonography; Pus culture; blood culture; Total Leucocyte Count.|14 days|||participants|||Number
418|NCT02687217|Primary|ASEPSIS Score|"ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection.~Category of infection:~Total score of 0–10 satisfactory healing; 11–20 disturbance of healing; 21–30 minor wound infection; 31–40 moderate wound infection; > 40 severe wound infection."|14 days|||participants|||Number
419|NCT02684604|Primary|Quantitative Helicobacter Pylori IgG Assay in Serum|calculation of quantitative Helicobacter pylori IgG assay in serum|24 hours|||arbitrary unit per millilitre||Inter-Quartile Range|Median
420|NCT02684396|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
421|NCT02684396|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
422|NCT02684396|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||hours||Full Range|Median
423|NCT02684396|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
424|NCT02684396|Primary|Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.||percentage of participants|||Number
425|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose|Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.||percentage of participants|||Number
8444|NCT02093702|Primary|Mean Change in HDL-C||Baseline and 12 months|||mmol/L||Full Range|Mean
427|NCT02684396|Primary|Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
428|NCT02683954|Primary|Serum Nesfatin 1|"Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay ELISA technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals."|24 hours|In the endometriosis group, two patients were stage I, one was stage II, 12 were stage III and 15 were stage IV according to the revised ASRM scoring system. In the control group, 13 had polycystic varies, 11 had variable pelvic peritoneal adhesions, 4 had tubal block , one had unilateral ovarian cyst and one patient had atrophic ovaries.||picogram/millilitre||Inter-Quartile Range|Median
429|NCT02681458|Primary|The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users||up to two months|||participants|||Number
430|NCT02679976|Primary|Intermediate Binocular LogMAR Visual Acuity|intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.||-10*LogMAR||Standard Deviation|Mean
431|NCT02679976|Primary|Near Binocular LogMAR Visual Acuity|Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.||-10*LogMAR||Standard Deviation|Mean
432|NCT02679976|Primary|Distance Binocular LogMAR Visual Acuity|Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.||-10*LogMAR||Standard Deviation|Mean
433|NCT02678676|Secondary|Incidences With Malignancies|Percentage of participants with incidences of at least 1 malignancy was reported. All malignancies included adrenal, biliary, bladder, brain, breast, cervix, colon/rectal, gastric, hematological, hepatic, lung, mesothelioma, metastases, oesophageal, oropharyngeal, ovarian/uterine, pancreas, prostate, renal, skin and others.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).||percentage of participants|||Number
434|NCT02678676|Primary|Percentage of Participants With First Occurrence of Macro-vascular Event or Death|The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).||percentage of participants|||Number
435|NCT02677779|Secondary|Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis|proportion of patients with bleeding necessitating haemostasis|during procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.||participants|||Number
436|NCT02677779|Secondary|Granulation: Percent of Ulcer Area Covered by Granulation.|Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.|Baseline and immediately after procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.||Percent change from baseline||Inter-Quartile Range|Median
437|NCT02677779|Secondary|Fibrin: Percent of Ulcer Area Covered by Fibrin|Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure|Baseline and immediately after the end of procedure|||Percent change from baseline||Inter-Quartile Range|Median
438|NCT02677779|Secondary|Pain: Scores of Brief Pain Inventory|Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.|During procedure.|ITT analysis: patients with no detectable bacterial load at baseline were included.||cm for a VAS scale.||Inter-Quartile Range|Median
439|NCT02677779|Primary|Bacterial Load|Percent change in bacterial colonies from baseline.|Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.|Per-protocol analysis: patients with no detectable bacterial load at baseline were excluded.||Percent change from baseline||Inter-Quartile Range|Median
440|NCT02677493|Secondary|Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28||||||
441|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28||||||
442|NCT02677493|Secondary|Difference in Seroconversion Rate||Day 28||||||
443|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).||Day 28||||||
444|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.||Day 28||12/2016||||
445|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroconversion, Respectively.|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28||12/2016||||
2096|NCT02441218|Secondary|Death From Heart Failure|Component of cardiovascular death|From the date of randomisation to death, up to 42 months.|||participants|||Number
446|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroprotection|Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.||percentage of subjects||95% Confidence Interval|Number
447|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroconversion|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.||percentage of subjects||95% Confidence Interval|Number
448|NCT02673944|Primary|Accurate Vesical PRessure|To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.|During a routine urodynamic study (1 hr approx)|||cm H2O||Standard Deviation|Mean
449|NCT02670811|Secondary|Triglycerides Measurements|Triglycerides measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
450|NCT02670811|Secondary|High Density Lipoproteins|High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
451|NCT02670811|Secondary|Low Density Lipoproteins Measurements|Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
452|NCT02670811|Secondary|Total Cholesterol Measurements|Total cholesterol in baseline and after 8 weeks of treatment (Intake period).|Baseline and 8th week|||mg/dL||Standard Deviation|Mean
453|NCT02670811|Secondary|Diastolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks post-treatment.|Baseline to 10 weeks|||mmHg||Standard Deviation|Mean
454|NCT02670811|Primary|Systolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.|Baseline to 10 weeks|||mmHg||Standard Deviation|Mean
455|NCT02666560|Secondary|Time Spent in Single Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||percentage of time||Standard Deviation|Mean
456|NCT02666560|Secondary|Time Spent in Double Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||percentage of time||Standard Deviation|Mean
457|NCT02666560|Secondary|Cadence as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of cadence was recorded in steps per minute.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||steps per minute||Standard Deviation|Mean
458|NCT02666560|Secondary|Step Time as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of step time was recorded in seconds.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||seconds||Standard Deviation|Mean
459|NCT02666560|Secondary|Velocity as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of velocity was recorded in cm's per second.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||cm/s||Standard Deviation|Mean
460|NCT02666560|Primary|Step Length as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of length was recorded in centimetres.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.|||cm||Standard Deviation|Mean
461|NCT02666222|Secondary|Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire|"APHAB results were obtained from baseline aided condition through Year 5 of follow up. The APHAB responses are in terms of percent of time an individual experiences problems, on a scale of 0-100%; lower scores indicate fewer problems.Compared scores with Esteem to scores in baseline aided condition, calculated as APHAB Global score at baseline minus APHAB Global score at Year 5, giving a difference in benefit score. The Global Score is the mean of the scores (% of problems) for Ease of Communication (EC), Reverberation (RV), and Background Noise (BN) subscales of the APHAB. A positive difference in benefit score indicates more benefit with Esteem."|Baseline through Year 5 of Follow Up|5 Year Follow-up||difference score in units on a scale||Full Range|Mean
462|NCT02666222|Primary|Bone Conduction Stability|ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.|Baseline through 5 Year Follow-Up|Difference between Baseline and 5 Year PTA (average of 500, 1000, 2000 Hz thresholds)||dB||Standard Error|Mean
463|NCT02666222|Primary|Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.|ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.|SADEs, PAS phase through Year 5 of Follow Up|Cumulative through 5-Year Follow-up||participants|||Number
464|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL|ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up Visit||percentage of correct responses||Standard Error|Mean
466|NCT02664987|Secondary|Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale|"The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 4:~0- Fully active, able to carry on all pre-disease performance without restriction~Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work~Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours~Capable of only limited self-care, confined to bed or chair more than 50% of waking hours~Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair~A higher score indicates greater functional impairment."|Day 1|||percentage of patients|||Number
467|NCT02664987|Secondary|Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient|"Patients answered yes or no to the following question:~Have you had trouble sleeping due to your cancer pain within the last 7 days?"|Past 7 days up to Day 1|||percentage of patients|||Number
468|NCT02664987|Primary|Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient|"Patients indicated their pain intensity using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).~Their current pain intensity and pain in the last 24 hours were indicated on separate scales. A higher score indicates higher pain intensity."|Past 1 day up to Day 1|||units on a scale||Standard Deviation|Mean
469|NCT02664987|Primary|Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient|EQ-5D-3L summary indices were calculated using the algorithm developed based on the valuation of EQ-5D-3L health states from an adult Thai population (Tongsiri & Cairns, 2011). Applying the Thai algorithm, EQ-5D-3L summary indices range from -0.45 to 0.80, with an EQ-5D-3L summary index of 0.80 indicating the best overall health-related quality of life.|Day 1|||units on a scale||Standard Deviation|Mean
470|NCT02664987|Primary|Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators|"The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:~Very satisfied~Satisfied~Acceptable~Dissatisfied~Very dissatisfied~Patients and Investigators will each indicate their opinion on separate scales."|Day 1|||percentage of patients|||Number
471|NCT02664987|Primary|Prescription Pattern of Analgesics (Opioid or Non-opioid)|At Visit 1 (Day 1) which was the only visit in the study, data was collected on whether each patient was receiving only opioid, only non-opioid or both opioid and non-opioid analgesic treatments for pain control.|Day 1|||percentage of patients||95% Confidence Interval|Number
472|NCT02664532|Secondary|Total Laryngoscopy Duration in Seconds|The duration of intubation was defined as the time taken from placement of the laryngoscope in the mouth to the time taken to remove the laryngoscope from the mouth following intubation.|180 seconds|||Seconds||Standard Deviation|Mean
473|NCT02664532|Secondary|Number of Intubation Attempts|An intubation attempt is defined as “intubation activities occurring during a single continuous laryngoscopy maneuver”. Thus, even if several attempts were made to place an endotracheal tube during the course of a single laryngoscopy, this would be counted as a single intubation attempt.|180 seconds|||participants|||Number
474|NCT02664532|Secondary|Cormack Lehane Grading|Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible|60 seconds|||participants|||Number
475|NCT02664532|Primary|Ease of Intubation or Degree of Difficulty With Intubation|Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope|60 seconds|||participants|||Number
476|NCT02663232|Secondary|Percentage of Participants With Adequate Quality/Quantity of Tumor Sample||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
477|NCT02663232|Secondary|Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique|The samples were classified based on the percentage of tumor cells referred to the technique as follows: <60 percent (%), 60-80%, >80% and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
478|NCT02663232|Secondary|Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
479|NCT02663232|Secondary|Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
480|NCT02663232|Secondary|Percentage of Participants With Vascular Invasion|Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
481|NCT02663232|Secondary|Percentage of Participants With Regression|Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
482|NCT02663232|Secondary|Percentage of Participants With Ulceration||Day 1|All participants enrolled in the study were included in the analysis||percentage of participants|||Number
483|NCT02663232|Secondary|Percentage of Participants Categorized by Breslow Thickness|Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
484|NCT02663232|Secondary|Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
485|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
489|NCT02663232|Secondary|Percentage of Participants Categorized by Primary Tumor Location|Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
490|NCT02663232|Secondary|Percentage of Participants With Sun Exposure|Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
491|NCT02663232|Secondary|Percentage of Participants With Family History of Melanoma||Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
492|NCT02663232|Secondary|Percentage of Participants Categorized by Melanoma Stage|Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.|Day 1|All participants enrolled in the study were included in the analysis.||percentage of participants|||Number
493|NCT02663232|Primary|Percentage of Participants With V600 BRAF Mutation Status|Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.|Day 1|All enrolled participants were included in the analysis.||percentage of participants||95% Confidence Interval|Number
494|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
495|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
496|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
497|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion: All observations of an episode of care with trastuzumab IV infusion that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
498|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab SC Injection: All observations of an episode of care with trastuzumab SC injection that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
499|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab Single-Use Injection Device: All observations of an episode of care with trastuzumab single-use injection device that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.||consumables|Participants|Standard Deviation|Mean
500|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
501|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
502|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
503|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample||minutes|Participants|Standard Deviation|Mean
504|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
505|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
506|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
507|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.||minutes|Participants|Standard Deviation|Mean
508|NCT02658461|Secondary|Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample||pounds|Participants|Standard Deviation|Mean
509|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample||pounds|Participants|Standard Deviation|Mean
510|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample: All observations of an episode of care for the given treatment route.||pounds|Participants|Standard Deviation|Mean
511|NCT02657629|Primary|Weight Gain in Grams Per Day||Daily until hospital discharge (up to maximum of 3 months of age)|||grams/day||Standard Deviation|Mean
512|NCT02657538|Secondary|Lesion Activity|active lesions: 1; inactive lesions: 0|One year|The data were not collected and the Outcome will never be analyzed because of the study population. The participants are all low risk in the analysis of caries, with low amount of gingivitis and good oral hygiene what means that no progression/ change in caries activity will be detectable in any patient. So it doesn't make sense to analyze it.|||||
525|NCT02645760|Primary|Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7|The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)|baseline an week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group.||units on a scale||Standard Deviation|Mean
526|NCT02644109|Primary|Serum LDL Cholesterol||1 month|||mg/dl||Standard Deviation|Mean
513|NCT02657538|Primary|Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)|"The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine~Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions.~Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them"|One year|||weighted Kappa|Participants|95% Confidence Interval|Mean
514|NCT02653560|Primary|24-hour Average Systolic Blood Pressure|Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.|4 weeks|||mmHg||Standard Deviation|Mean
515|NCT02650219|Secondary|Number of Patients With : Antinuclear and/or Anti-SSa and/or Anti-SSb and/or Anti-RNP and/or Anti-DNA and/or Anti-Sm and/or Anticardiolipid and/or Anti β2Gp1 and/or Antiganglioside Autoantibodies (Genetics Analyses From Blood Samples)|data available from biological analyses (blood samples)|baseline|antinuclear autoantibodies||participants|||Number
516|NCT02650219|Secondary|Number of Patients With : Photosensitivity and/or Raynaud Phenomenon and/or Sicca Syndrome and/or Arthralgia and/or Arthritis and/or Thrombosis (Medical History and Questionnaire)|Features usually associated with auto immune disease- data available from medical record of the patients|Baseline||||||
517|NCT02650219|Secondary|Number of Patients With : Splenectomy and/or Bone Events and/or Pulmonary Hypertension and/or Specific Treatment and Non-specific (Medical History,Physiological Parameters and Questionnaire)|data available from medical record of the patients|Baseline|splenectomy testing||participants|||Number
518|NCT02650219|Primary|Number of Patients With GD Diagnosis Confirmed by : Enzyme Testing of acidβ-glucosidase Activity Activity <15% in Blood Leucocytes Completed When Necsssary by GB1 Mutation Analyses (Analyses From Samples)|"acidβ-glucosidase enzyme testing : a lower than 15% of mean normal activity is considered to be diagnostic.~Decreased enzyme levels will often be confirmed by genetic testing. Numerous different mutations occur; GB1 mutation analyses is sometimes necessary to confirm the diagnosis."|baseline|||participant|||Number
519|NCT02648022|Secondary|Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%|Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks|||percentage of participants|||Number
520|NCT02648022|Secondary|Percentage of Participants With Treatment Initiation and Completion|The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks|||percentage of Particpants|||Number
521|NCT02648022|Primary|Sustained Viral Response (SVR)|The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.|up to 24 weeks|||percentage of Participants|||Number
522|NCT02645760|Secondary|Change From Baseline in Repositioning Error on Repositioning Test at Week 7|This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group||centimeter||Standard Deviation|Mean
523|NCT02645760|Secondary|Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober’s Test at Week 7|Modified-modified Schober’s test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group||centimeter||Standard Deviation|Mean
524|NCT02645760|Secondary|Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7|This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group||units on a scale||Standard Deviation|Mean
2097|NCT02441218|Secondary|All-cause Mortality||From the date of randomisation to death, up to 42 months.|||participants|||Number
527|NCT02644096|Primary|Change in Physical Dimensions in Health Status of Elderly Patients From 4 Weeks Pre Operatively to 9 Months Post Operatively After THR. Health Status is Measured by the Questionnaire Short-form 36 (SF-36).|"The health status was assessed by Short-Form 36 (SF-36) which is a self-administered generic questionnaire that has been shown to be reliable and valid for measuring functioning, well-being and general health status. The instrument measures the eight health dimensions listed in figure 3. Reflecting the impact of both dysfunctions and general health perception the questionnaire measures: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score).~All patients who had been consecutively admitted for THR were mailed an introduction letter together with a questionnaire containing a number and a prepaid return envelope. In the questionnaire they were asked to give demographic data and assess their health status"|Four weeks preoperatively and nine moths after discharge.|Patients who have completed the study and contributed with answers on the SF-36 questionnaire.||Scores on SF-36 questionnaires||95% Confidence Interval|Mean
528|NCT02643225|Primary|The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)|The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.|at birth|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.||participants|||Number
529|NCT02643225|Secondary|Interventricular Septum Thickness|The interventricular septum thickness will be measured by ultrasound examination|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.||mm||Standard Deviation|Mean
530|NCT02643225|Secondary|Prediction of Fetal Macrosomia by Measuring HbA1C in Participants|Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee||percentage of glycosolated hemoglobin||Standard Deviation|Mean
531|NCT02643225|Secondary|Umbilical Cordcross-sectional Area|the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee||cm^2||Standard Deviation|Mean
532|NCT02641912|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events on administration of investigational product from screening (Day 1) to 5 days after last administration of the product on Day 8. Number of participants with TEAEs were reported.|up to 13 days|Analysis for this outcome was conducted on safety population which included all participants who were randomized and received at least one dose of study treatment during the study.||Number of participants|||Number
533|NCT02641912|Secondary|Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8|Participants answered 4 questions on PPUSQ as follows: Q1:Which of the following statements best describes how much you liked the product overall?(rated on scale of 1-6, 1=Did not like it at all; 2=Did not like it that much; 3=Like it slightly; 4=Like it somewhat; 5=Like it very much; 6=Like it extremely), Q2:How pleasant would you say the flavor of the product was?(rated on scale of 1-5, 1=Not pleasant at all; 2=Slightly pleasant; 3=Moderately pleasant; 4=Very pleasant; 5=Extremely pleasant), Q3:How gentle would you say the product was?(rated on a scale of 1-7, 1=Not gentle at all; 2=Barely gentle; 3=Slightly gentle; 4=Moderately gentle; 5=Very gentle; 6=Extremely gentle; 7=The most gentle product imaginable), Q4:How fresh would you say your mouth felt after using the product?(rated on a scale of 1-5; 1=Not at all fresh; 2=Not very fresh; 3=Somewhat fresh; 4=Very fresh; 5=Extremely fresh) & response to these questions was reported. Scale score was averaged to calculate the response|Day 1, Day 3, Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||score on a scale||Standard Error|Least Squares Mean
534|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It’s a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life. Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1:Uncomfortable; M2:Bad taste; M3:Loss of Taste; M4:Lips sticking to roof of mouth; M5:Tongue sticking to roof of mouth; M6: Throat dry; M7:No moisture; M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
576|NCT02641379|Secondary|Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)|End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
8901|NCT02075073|Primary|Maximum Serum Concentration (Cmax)||57 days|||µg/mL||Standard Deviation|Mean
535|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8|Number of participants were reported who answered following questions, these questions are about how you have coped with your dry mouth over last week. Please tell us whether you agree or disagree with each of the statements. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, There are other things that help some people with dry mouth. Please tell us how often over last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
536|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8|Number of participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people’s moods and emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over the last week Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, and How much do you agree or disagree that your dry mouth has affected your time with other people over last week? Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
537|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8|Number of participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem?; Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, and How much do you recognize yourself in following statements, based on last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
538|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It’s a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life; Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1: Uncomfortable; M2: Bad taste; M3:Loss of Taste; M4: Lips sticking to roof of mouth; M5: Tongue sticking to roof of mouth; M6: Throat dry; M7: No moisture M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
539|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1|Number of participants were reported who answered following questions, these questions were about how participants had coped with their dry mouth over the last week with respect to agree or disagree with each of the following questions. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to the toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, and There are other things that help some people with dry mouth. Please tell us how often over the last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
566|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)|The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed for a given time point.||scores on a scale||Standard Deviation|Mean
2098|NCT02441218|Secondary|Hospitalisation for Worsening Heart Failure||From the date of randomization to the date of first documented hospitalisation, up to 42 months|||participants|||Number
540|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1|Number of Participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people’s moods & emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over last week; Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, How much do you agree or disagree that your dry mouth has affected your time with other people over the last week?; Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone; Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
541|NCT02641912|Secondary|Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1|Number of Participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem? Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, How much do you recognize yourself in following statements, based on the last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||Number of participants|||Number
542|NCT02641912|Secondary|Mean Response to SAoP QoL 2 Prior to Treatment on Day 8|Participants answered to the 6 questions in SAoP QoL 2 as follows: Q1= Looking back over the last 7 days, has your dry mouth caused discomfort?; Q2= Looking back over the last 7 days, has your dry mouth made it uncomfortable to speak?; Q3= Looking back over the last 7 days, has your dry mouth interrupted your sleep?; Q4= Looking back over the last 7 days, has your dry mouth affected your social interactions?; Q5= Looking back over the last 7 days, has your dry mouth caused you to avoid certain foods?; Q6= Looking back over the last 7 days, has your dry mouth interfered with your daily activities? These questions were rated on scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||score on a scale||Standard Deviation|Mean
543|NCT02641912|Secondary|Mean Response to Subjective Assessment of Patient’s Quality of Life (SAoP QoL1) Prior to Treatment on Day 1|Participants answered to the 6 questions in SAoP QoL as follows: Q1= Does your dry mouth cause discomfort?; Q2= Does your dry mouth make it uncomfortable to speak?; Q3= Does your dry mouth interrupt your sleep?; Q4= Does your dry mouth affect your social interactions?; Q5= Does your dry mouth cause you to avoid certain foods?; Q6= Does your dry mouth interfere with your daily activities? These questions were rated on a scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.||score on a scale||Standard Deviation|Mean
544|NCT02641912|Secondary|Mean Response to PPAQ4 Prior to Treatment on Day 3|Participants answered to the 9 questions in PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|Prior to treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
545|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
589|NCT02630563|Secondary|Time to Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|Tmax is the amount of time after dosing to when the maximum concentration of MPA and MPAG was achieved.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.||hour||Full Range|Median
546|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
547|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3|Participants answered the 14 questions of PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
548|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3|Participants answered to the 11 questions in PPAQ2 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
549|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3|Participants answered to the 3 questions in PPAQ1 as follows: Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
550|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
551|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
590|NCT02630563|Secondary|Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was obtained directly from the measured plasma concentration-time curves.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.||mcg/mL||Standard Deviation|Mean
36227|NCT01504867|Secondary|Hospital Mortality||28 days|Intention-to-Treat||participants|||Number
552|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
553|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1|Participants answered to the 11 question in PPAQ2. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
554|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1|Participants answered to the 3 question in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
555|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8|Participants answered the 9 questions of PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
556|NCT02641912|Secondary|Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
557|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
575|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)|The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
558|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
559|NCT02641912|Secondary|Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8|Participants answered questions, Q2-Q11 in PPAQ2. Q2=Feeling comfortable in the mouth; Q3=Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q=9 Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on a scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
560|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8|Participants answered 3 questions in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
561|NCT02641912|Secondary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8|Participants answered to the question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 and 240 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.||score on a scale||Standard Deviation|Mean
562|NCT02641912|Secondary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8|Participants answered to the question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ2 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.||score on a scale||Standard Deviation|Mean
563|NCT02641912|Primary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8|Participants answered question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 8|Intent-to-treat (ITT) population which included all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.||score on a scale||Standard Deviation|Mean
564|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 2)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.||Number of participants|||Number
565|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)|Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.|Baseline (Day 1)|The ITT population included all participants randomized and allocated to receive treatments.||Number of participants|||Number
2099|NCT02441218|Secondary|Cardiovascular Death|Component of the primary composite endpoint|From the date of randomization until the date of death, up to 42 months|||participants|||Number
567|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)|The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.||scores on a scale||Standard Deviation|Mean
568|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)|The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
569|NCT02641379|Secondary|Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)|ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
570|NCT02641379|Secondary|Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)|Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.||Percentage of participants||95% Confidence Interval|Number
571|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 1)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.||Number of participants|||Number
572|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)|Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.|Baseline (Day 1)|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.||Number of participants|||Number
573|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)|The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.||scores on a scale||Standard Deviation|Mean
574|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)|The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.||scores on a scale||Standard Deviation|Mean
619|NCT02619799|Secondary|Onset of Sensory Blockade|the onset time of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..|||time in minutes||Standard Deviation|Mean
37711|NCT01481740|Primary|Incidence of Nausea and Vomiting||intraoperative|||participants|||Number
577|NCT02641379|Primary|Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)|The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.||Percentage of participants||95% Confidence Interval|Number
578|NCT02641379|Primary|Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)|Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.||Percentage of participants||95% Confidence Interval|Number
579|NCT02638051|Secondary|Quality of Life (QoL)|"Karnofsky Performance Score Improvement Rate (KPS IR)~Improvement: increase of KPS for ≥10% after treatment.~Worsening: reduction of KPS for ≥10% after treatment.~NC: change of KPS for <10%."|8 weeks after start of treatment (4 weeks on completion of treatment)|||percentage of participants|||Number
580|NCT02638051|Secondary|Adverse Events Rate (AER)|Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.|During 4 weeks of treatment course and 4 weeks after treatment|||participants|||Number
581|NCT02638051|Primary|Objective Response Rate (ORR)|"Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR)~WHO criteria of therapeutic effect evaluation at malignant ascites:~Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month.~Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month.~No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention."|8 weeks after start of treatment (4 weeks on completion of treatment)|||percentage of participants|||Number
582|NCT02635425|Primary|Number of Participants of Severe Ovarian Hyperstimulation Syndrome||2 weeks|||participants|||Number
583|NCT02633787|Primary|Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster, 28 Days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
584|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
585|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days, and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
586|NCT02630563|Secondary|Plasma Concentration of Mycophenolic Acid and Its Metabolite Mycophenolic Acid Glucuronide at Each Time Point|Mycophenolic Acid Glucuronide (MPAG) is an active metabolite of Mycophenolic Acid (MPA).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol.||mcg/mL||Standard Deviation|Mean
587|NCT02630563|Primary|Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours of Mycophenolic Acid Normalized for Dose And for Body Surface Area|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC0-12h was normalized to 600 milligram per square meter (mg/m^2) and 1.5 gram. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The pharmacokinetic (PK) population included all randomized and replaced participants adherent to the PK section of the protocol.||mcg*h/mL||Standard Deviation|Mean
588|NCT02630563|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Day 32|The safety population included all participants who were enrolled in the trial||participants|||Number
591|NCT02630563|Secondary|Area Under the Plasma Concentration Time Curve From 0-12 Hours for Mycophenolic Acid and Mycophenolic Acid Glucuronide Phenolic Glucuronide of Mycophenolic Acid|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol||mcg*h/mL||Standard Deviation|Mean
592|NCT02628418|Secondary|The Costs Involved in Using Gloreha in the Rehabilitation|Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.|Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.|||Euros/patient|||Number
593|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.|"The Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.~The Quick-DASH is a 19-item ordinal scale with a 5-level rating of items from 1 (no difficulty) to 5 (unable to do).~Quick-Dash can be divided into an 11-item (abilities and symptoms) and an 8-item optional work module and sports/performing arts module. In the 11-item sub-scale, the subject defines the ability to perform some actions (8 items) and the intensity of some symptoms (3 items), referring to the previous week. The total score range is from 19 (no disability) to 95 (full disability)."|Baseline and end of the study after 30 sessions, an average of 6 weeks|||units on a scale||95% Confidence Interval|Mean
594|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.|The Pinch test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks|||kg / (kg / m ^ 2||95% Confidence Interval|Mean
595|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.|The Grip test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks|||kg / (kg / m ^ 2)||95% Confidence Interval|Mean
596|NCT02628418|Secondary|The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)|The feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult). This outcome was measured only in the Gloreha Group in which patients were treated with device.|Baseline and end of the study after 30 sessions, an average of 6 weeks|||units on a scale||Standard Deviation|Mean
597|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.|Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.|Baseline and end of the study after 30 sessions, an average of 6 weeks|||pegs/sec||95% Confidence Interval|Mean
598|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation|"Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction.~The total upper extremity score involved adding one to the sum of the three actions.~The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100."|Baseline and end of the study after 30 sessions, an average of 6 weeks|||units on a scale||95% Confidence Interval|Mean
599|NCT02628418|Primary|Side Effects Using Gloreha Device|The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);|Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.|||side effects|||Number
600|NCT02628418|Primary|Number of Patients Who Completed the Hand Rehabilitation Program||Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.|||participants|||Number
601|NCT02628938|Secondary|Self-assessment of Mouth Odor After 7 Days of Use|"Participants were asked to score their own halitosis on a continuous 10-cm visual analogue scale that is marked as no odor on the 0-cm end, and as extremely foul odor on the 10-cm end"|After 7 days of first use|||units on a scale||Standard Deviation|Mean
602|NCT02628938|Secondary|Volatile Sulfur Compound Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect)|Scores using breath checker device (Tanita FitScan HC-212SF Breath Checker) were recorded (0=no odor, 1=slight odor, 2=moderate odor, 3=heavy odor, 4=strong odor, 5=intense odor).|After the first use of the prescribed method by 15 minutes, and after 7 days of use|||units on a scale||Standard Deviation|Mean
620|NCT02619799|Primary|Duration of Postoperative Analgesia|pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.|first 12 hours after completion of surgery.|||time in minutes||Standard Deviation|Mean
2834|NCT02368314|Secondary|Frequency of Clinically Significant Bleedings||During the treatment period (14 days)||||||
603|NCT02628938|Primary|Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).|"The Organoleptic scores were obtained by a calibrated judge who first tested her ability to detect and distinguish odors even at low concentrations using the Smell Identification Test (Sensonics Inc., Haddon Heights, NJ, USA).~To obtain the score, the patient was asked to close her mouth for approximately 3 minutes while breathing only from the nose. Then he/she was asked to release air from the mouth slowly. The judge kept a distance of about 10 cm between her nose and the patient's mouth to determine the score based on the intensity of the odor.~The intensity ratings of 0 to 5 score was used where Score 0 stands for No odor present, score 1 stands barely noticeable odor, score 2 stands slight but clearly noticeable odor, score 3 stands moderate odor, score 4 stands strong offensive odor and a Score 5 stands extremely foul odor."|After the first use of the prescribed method by 15 minutes, and after 7 days of use|||units on a scale||Standard Deviation|Mean
604|NCT02628106|Primary|the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI|the R2* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue|baseline and after 14days of lipo-PGE1 intravenously|A random sample, west China hospital, in accord with a standard 21 people,age > 18 years||1/ms||Standard Deviation|Mean
605|NCT02627144|Primary|Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine||Up to 52 weeks|FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically.|||||
606|NCT02627144|Primary|Overall Survival (OS) Time|OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS||months||95% Confidence Interval|Median
607|NCT02627144|Primary|Progression-free Survival (PFS) Time|PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS||months||95% Confidence Interval|Median
608|NCT02627144|Primary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|FAS. ‘Number of participants analyzed’ indicate participants who were evaluable for this measure.||percentage of participants|||Number
609|NCT02627144|Primary|Percentage of Participants With Best Overall Tumor Response|Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data.||percentage of participants|||Number
610|NCT02627001|Primary|Received Minute Volume (Liters) as Measured by Wright Respirometer|An Impact 731 Ventilator will be attached to a mask. Subjects will hold a mask seal on a cadaver for 100 seconds. The Impact 731 Ventilator will then deliver standardized tidal volumes of 750 cc (delivered tidal volume) 10 times at six second intervals. A Wright respirometer will then measure received tidal volume for each of these 10 breaths.|1 Minute|||Liters||Inter-Quartile Range|Median
611|NCT02625844|Primary|Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs)|Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs)|Up to 3 months|||hours/year|||Number
612|NCT02621034|Primary|Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval||72 hours|||units on a scale||Standard Deviation|Mean
613|NCT02621034|Primary|Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals||72 hours|||units on a scale||Standard Deviation|Mean
614|NCT02621034|Primary|Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval|The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10).|6 hours|||units on a scale||Standard Deviation|Mean
615|NCT02619799|Secondary|Perioperative Side Effects|through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.|through out the intraoperative period and first 12 postoperative hours.|||participants|||Number
616|NCT02619799|Secondary|Duration of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.|||time in minutes||Standard Deviation|Mean
617|NCT02619799|Secondary|Onset of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.|||time in minutes||Standard Deviation|Mean
618|NCT02619799|Secondary|Duration of Sensory Blockade|the duration of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..|||time in minutes||Standard Deviation|Mean
621|NCT02619591|Primary|Pneumothorax (Positive or Negative)|The presence of a pneumothorax at the time of the ultrasound|up to 20 minutes|||participants|||Number
622|NCT02618772|Other Pre-specified|Guardian/Parent's Prediction is Respect to Intervention Drug|This is a measure how how many times the parent/guardian was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: parent asked immediately after procedure complete|||Times correct|||Number
623|NCT02618772|Other Pre-specified|Physician's Prediction is Respect to Intervention Drug|This is a measure how how many times the physician was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: physician asked immediately after procedure finished|||Times correct|||Number
624|NCT02618772|Other Pre-specified|Length of Procedure (Mins)|This is a measure of the length of the procedure (suturing) in minutes.|Day 1|||minutes||Standard Deviation|Mean
625|NCT02618772|Other Pre-specified|Time That the Participant Remained in Hospital After Procedure (Mins)|Length of stay in the emergency department, measured from the end of the procedure to the time of discharge.|Day 1: at discharge from emergency department (i.e. same day)|||minutes||Standard Deviation|Mean
626|NCT02618772|Secondary|Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.~FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
627|NCT02618772|Secondary|Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.~FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
628|NCT02618772|Secondary|Per-Protocol: Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
629|NCT02618772|Secondary|Intention to Treat (ITT): Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
630|NCT02618772|Secondary|Per-Protocol: State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
631|NCT02618772|Secondary|Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
640|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
687|NCT02615717|Primary|Clinician-Administered PTSD Scale (CAPS-5)|Assesses symptoms and severity of Posttraumatic Stress Disorder Range: 0-80; total score utilized. Higher values indicate higher severity Subscales are summed to create a total score; subscales made up of different facets of PTSD.|within three days|||units on a scale||Standard Deviation|Mean
632|NCT02618772|Secondary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: Baseline, Intervention & Lidocaine|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
633|NCT02618772|Secondary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During Baseline, Intervention & Lidocaine|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
634|NCT02618772|Primary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.||units on a scale||Standard Deviation|Mean
635|NCT02618772|Primary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.||units on a scale||Standard Deviation|Mean
636|NCT02617888|Primary|Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging|The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA.|Change from baseline double strand DNA breaks at 30 minutes post-imaging|Female patients 18 years or older who were clinically referred to undergo coronary CT angiography between August 2012 and July 2014 at Walter Reed National Military Medical Center (Bethesda, Maryland) were eligible for enrollment.||gamma-H2AX foci in blood lymphocytes||Standard Deviation|Mean
637|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
638|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
639|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
641|NCT02617784|Secondary|CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
642|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
643|NCT02617784|Secondary|CLr of Oseltamivir in CAPD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
644|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose|PK Analysis Population.||L/h||Standard Deviation|Mean
645|NCT02617784|Secondary|CL/F of Oseltamivir in CAPD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose|PK Analysis Population.||L/h||Standard Deviation|Mean
646|NCT02617784|Secondary|Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.||hours||Standard Deviation|Mean
647|NCT02617784|Secondary|Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h).|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.||1/h||Standard Deviation|Mean
648|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||hours||Standard Deviation|Mean
649|NCT02617784|Secondary|Tmax of Oseltamivir in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||hours||Standard Deviation|Mean
650|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||ng/mL||Standard Deviation|Mean
651|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.||ng/mL||Standard Deviation|Mean
652|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants|Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population.||ng/mL||Standard Deviation|Mean
653|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of osteltamivir dose||Standard Deviation|Mean
654|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||percentage of oseltamivir dose||Standard Deviation|Mean
655|NCT02617784|Secondary|Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population; n = number of participants included in the specific dose analysis.||L/h||Standard Deviation|Mean
656|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
657|NCT02617784|Secondary|Renal Clearance (CLr) of Oseltamivir in HD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||L/h||Standard Deviation|Mean
658|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||L/h||Standard Deviation|Mean
659|NCT02617784|Secondary|Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||L/h||Standard Deviation|Mean
660|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||hours||Standard Deviation|Mean
661|NCT02617784|Secondary|Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.||hours||Standard Deviation|Mean
662|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; n = number of participants included at specified timepoints in the analysis.||ng/mL||Standard Deviation|Mean
663|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; number (n) equals (=) number of participants included at specified timepoints in the analysis.||ng/mL||Standard Deviation|Mean
664|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
665|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
666|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
688|NCT02614924|Secondary|Intubation Time||up to 10 minutes|||seconds||Inter-Quartile Range|Median
667|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
668|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).||ng/mL||Standard Deviation|Mean
669|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng/mL||Standard Deviation|Mean
670|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose|PK Analysis Population (Second Dose Subpopulation).||ng/mL||Standard Deviation|Mean
671|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng/mL||Standard Deviation|Mean
672|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
673|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
674|NCT02617784|Primary|AUC of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
675|NCT02617784|Primary|Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng*h/mL||Standard Deviation|Mean
676|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).||ng/mL||Standard Deviation|Mean
677|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).||ng/mL||Standard Deviation|Mean
678|NCT02617784|Primary|Cmax of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose|PK Analysis Population (Second Dose Subpopulation): All participants who completed treatment and provided evaluable data during the second dose assessment period.||ng/mL||Standard Deviation|Mean
679|NCT02617784|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose|Pharmacokinetic (PK) Analysis Population (First Dose Subpopulation): All participants who completed treatment and provided evaluable data during the first dose assessment period.||ng/mL||Standard Deviation|Mean
680|NCT02616523|Other Pre-specified|Complication|complications such as obstipation in the postoperative period|up to two weeks||||||
681|NCT02616523|Secondary|Neuropathic Pain (Pain Questionnaire) dn4|Pain questionnaire dn4 will be send to participants after two months of surgery to evaluate the neuropathic pain. There are minimum 0 points and maximum 10 points. If the score is 4 or higher then the pain is likely to be neuropathic pain.|two months after the surgery|||units on a scale||Standard Deviation|Mean
682|NCT02616523|Secondary|Consumption of Piritramide|consumption of piritramide (mg) in the recovery room|one hour after the operation|||mg||Standard Deviation|Mean
683|NCT02616523|Primary|Consumption of Fentanyl|consumption of fentanyl (mg) during the procedure|time of the operation|||mg||Standard Deviation|Mean
690|NCT02612077|Secondary|Quality of Life - Global Health Status|Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).|Baseline, 6 and 12 months|Participants in the efficacy analysis set who filled out the questionnaire at inclusion||units on a scale||Inter-Quartile Range|Median
691|NCT02612077|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.|Up to 36 months|Efficacy analysis set receiving bevacizumab at inclusion||Months||95% Confidence Interval|Median
692|NCT02612077|Primary|Progression-free Survival|Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively|within 36 months|Efficacy analysis set receiving bevacizumab at inclusion||Months||95% Confidence Interval|Median
693|NCT02611765|Primary|Treatment Success Defined as a Decrease in Rapid Plasma Reagin (RPR) Titer of >= 2 Dilutions (4-fold)|Number of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.|12 months|||participants|||Number
694|NCT02610634|Other Pre-specified|Geriatric Depression Scale (GDS-15)|This involves 15 questions about the mood of the subjects. Scores of 0 to 4 to be in the normal range, 5 to 9 to indicate mild depression, and 10 to 15 to indicate moderate to severe depression.|Session 1 (full session lasts approx. 3 hours)||||||
695|NCT02610634|Other Pre-specified|Addenbrookes Cognitive Examination (ACE-R)|The ACE-R involves testing of attention, orientation, memory, fluency, language and visuospatial abilities.|Session 1 (full session lasts approx. 3 hours)||||||
696|NCT02610634|Other Pre-specified|Montreal Cognitive Assessment (MoCA)|Different cognitive domains are assessed (attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation).|Session 1 (full session lasts approx. 3 hours)||||||
697|NCT02610634|Other Pre-specified|Falls Efficacy Scale – International (FES-I)|Fear of falling will be measured using the falls efficacy scale – international version. This is a short and valid measure of fear of falling in older adults, which assesses basic and demanding activities (both physical and social). It consists of 16 scenarios (e.g. cleaning the house) and subjects must rate their fear of falling on a scale from 1 (Not at all concerned) to 4 (Very concerned).|Session 1 (full session lasts approx. 3 hours)||||||
698|NCT02610634|Other Pre-specified|Freezing of Gait (FOG) Questionnaire|This is a 10 item questionnaire intended to classify freezing of gait. The questionnaire has 3 parts; distinction of freezers from non-freezers, Freezing severity, frequency and duration and impact of freezing on daily life.|Session 1 (full session lasts approx. 3 hours)||||||
699|NCT02610634|Other Pre-specified|Hoehn & Yahr (H & Y) Scale|The Hoehn and Yahr rating scale is a widely used clinical rating scale, which defines broad categories of motor function in Parkinson’s disease (PD). All participants’ will be tested who are in H &Y stages I-III.|Session 1 (full session lasts approx. 3 hours)||||||
700|NCT02610634|Other Pre-specified|The Unified Parkinson's Disease Rating Scale (UPDRS)|The Unified Parkinson's Disease Rating Scale will be used to assess motor and non-motor features of PD and disease severity. The UPDRS is scored from a total of 195 points; higher scores reflect worsening disability.|Session 1 (full session lasts approx. 3 hours)||||||
701|NCT02610634|Other Pre-specified|Contrast Sensitivity|CS will be measured using the Mars CS sheets placed on an adjustable holder. The sheet consists of 48 Latin letters of uniform height; the contrast from the white background decreases with subsequent letters. Room illumination is adjusted so that average CS sheet luminance is between 80 and 120cd/m² (measured via a luminance meter). Assessment is done binocularly with the average distance from the patients eyes being 50cm. Participants read aloud down the sheet starting at the top left. Errors are recorded on the pre-set score sheet and testing is terminated after 2 consecutive errors.|Session 1 (full session lasts approx. 3 hours)||||||
702|NCT02610634|Other Pre-specified|Visual Acuity|VA is measured binocularly used a standard LogMAR chart. Participants will be seated at a distance of 4m from the chart. Participants will be instructed to read aloud down the chart starting from the top left.|Session 1 (full session lasts approx. 3 hours)||||||
703|NCT02610634|Other Pre-specified|Visual Object and Space Perception Battery (VOSP)|This study will use a selection of these tests; incomplete letters, dot counting and position discrimination.|Session 1 (full session lasts approx. 3 hours)||||||
704|NCT02610634|Other Pre-specified|Clock Copying (CLOX 1 and 2)|Participants are required to draw a clock with the numbers and arrows pointed at a particular time. Then the subjects have to copy a clock drawn by the researcher.|Session 1 (full session lasts approx. 3 hours)||||||
705|NCT02610634|Other Pre-specified|Benton’s Judgement of Line Orientation (JLO) Test|JLO is a test of visuospatial ability, which involves a subject viewing a set of numbered lines and then being shown two lines of the same orientation. Participants then have to name the numbers that the shown lines correspond to.|Session 1 (full session lasts approx. 3 hours)||||||
706|NCT02610634|Other Pre-specified|CDR Attention Battery (Cognitive Drug Research – CDR, United Biosource Corporation, UK)|The Attention CDR involves a series of computerised tests, which the subjects respond to by pressing one of two buttons. Scores for sub-sections of Simple reaction time, Digit vigilance and Choice reaction time will be obtained.|Session 1 (full session lasts approx. 3 hours)||||||
707|NCT02610634|Secondary|Visual Sampling Parameter: Number of Blinks During Gait|Number of blinks observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)||||||
708|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Duration During Gait|Duration (ms) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
991|NCT02567188|Primary|Mean Hb Value at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
709|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Duration During Gait|Duration (ms) of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
710|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Number During Gait|Number of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
711|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Acceleration During Gait|Acceleration (degrees per second squared) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
712|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Amplitude During Gait|Distance (degrees) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
713|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Velocity During Gait|Velocity (degrees per second) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
714|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Number During Gait|Number of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)||||||
715|NCT02610634|Secondary|Gait Parameter: Double Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
716|NCT02610634|Secondary|Gait Parameter: Single Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
717|NCT02610634|Secondary|Gait Parameter: Step Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)||||||
718|NCT02610634|Secondary|Gait Parameter: Step Length|Measured in meters recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
719|NCT02610634|Secondary|Gait Parameter: Gait Speed|Measured in meters per second observed when walking recorded via Vicon 3D motion capture. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||||
720|NCT02610634|Primary|Visual Sampling Parameter: Saccade Frequency During Gait|Number of fast eye movements made per second observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||Saccade frequency (sacc/sec)||Inter-Quartile Range|Median
721|NCT02609178|Primary|△DT Value|"Disocclusion time (DT) is defined as the time from maximum intercuspation to complete disocclusion during lateral movement. DT related tooth contacts with muscle activity. Abnormities in DT would result in change of muscle activity, thus facilitate the occurrence of temporomandibular joint disorders.~In the study, the DT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.~△DT was calculated for minimizing individual difference among participants. The equation for △DT was: △DT(FGP/ AVR/ CON)= DT (FGP/ AVR/ CON)-DT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||seconds||Standard Deviation|Mean
722|NCT02609178|Secondary|Likert's Scale|"The questionaire was designed to evaluate participants' feeling towards the occlusal interference. It would be given to the subject after immediately try-in the crowns. In the questionaire:~Score 0 = No interference (feel comfortable while biting on the artificial crown) Score 1 = Moderate interference(could feel the artificial crown is higher when biting on the artificial crown, but when firmly clenched, the upper teeth could bite on the lower ones) Score 2 = High interference(the artificial teeth is higher that the upper teeth couldn't bite on all the lower teeth when firmly clenched)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||participants|||Number
723|NCT02609178|Secondary|Occlusal Adjusting Time for Crowns|Try-in procedure would be finished by the same clinician. The occlusal adjusting time would be counted using a timer and recorded.|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||minutes||Standard Deviation|Mean
744|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)|Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
2835|NCT02368314|Secondary|Frequency of Clinically Significant “Small” Bleedings||During the treatment period (14 days)||||||
724|NCT02609178|Primary|△OT Value|"Occlusion time (OT) is defined as the time from the first contact of occluding teeth to maximum intercuspation. OT is directly related with patients’ occlusal contact pattern; and some have considered it as a capable description of occlusion.~In the study, the OT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.~△OT was calculated for minimizing individual difference among participants. The equation for △OT was:△OT(FGP/ AVR/ CON)= OT (FGP/ AVR/ CON)-OT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.||seconds||Standard Deviation|Mean
725|NCT02608489|Secondary|Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort|Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.|12 weeks|Overall, 1 of 31 patients (3.22%), a 64-year-old man who underwent bilateral sequential same-day cataract surgery, stopped using the study eye drops owing to severe irritation in the D group.||participants|||Number
726|NCT02608489|Secondary|Grades of Anterior Chamber Cells.|"Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.~grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam"|12 weeks|||grade|Participants|Standard Deviation|Mean
727|NCT02608489|Primary|Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).~0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)"|12 weeks|||Scores on a scale|Participants|Standard Deviation|Mean
728|NCT02608489|Primary|Corneal Fluorescein Staining That is Related to Dry Eye Severity.|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).~0 : best score (no corneal damage) 15 : worst score (severe corneal damages)"|12 weeks|||scores|Participants|Standard Deviation|Mean
729|NCT02608489|Primary|Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.|TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.|12 weeks|||seconds|Participants|Standard Deviation|Mean
730|NCT02608489|Primary|Changes in HOAs After Blinking That is Related to Dry Eye Severity.|Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.|12 weeks|||microns|Participants|Standard Deviation|Mean
731|NCT02608489|Primary|Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.|Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.|12 weeks|||mm|Participants|Standard Deviation|Mean
732|NCT02608489|Primary|an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.|The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.|12 weeks|||scores on a scale|Participants|Standard Deviation|Mean
733|NCT02606734|Primary|Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure|The subject is exited from the study once they are discharged.|1 Day|||percent of contrast media saved||Standard Deviation|Mean
734|NCT02603666|Primary|Elastographic Value in kPa Measured by Fibroscan|Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.|Within 28 days in connection with their annual evaluation at a single point of time|||kPa||95% Confidence Interval|Mean
735|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with a radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3.5(±0.5)-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. Initial relative crest iRC will be determined as described above from the initial CBCT. In the second CBCT, vertical distance from the iRC from initial CBCT will be used to recreate the iRC. New relative crest will be determined for each of the three planes (nRC) as above. The difference between iRC and nRC indicates change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.|3-4 months|Change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.||millimeters||Standard Deviation|Mean
799|NCT02590562|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population||tender joint count||Standard Deviation|Mean
2836|NCT02368314|Secondary|Frequency of “Big” Bleedings||During the treatment period (14 days)||||||
736|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. The initial relative crest (iRC) reference point will be determined. The buccal and lingual crests at the central plane of site will be marked and distances from this crest to RRP will be measured in mm. The average distance of the buccal crest height and the lingual crest height will be calculated and that value will be used to determine the iRC for that site. Initial Bucco-lingual (iRBL) measurements will be recorded at 1 mm, 3 mm and 7 mm from iRC in all five planes. The final bucco-lingual (fRBL) measurements will be recorded on the second CBCT, using the same method as described before and using the iRC reference. Differences between iRBL and the fRBL reflect change in horizontal ridge width (RΔHD).|3-4 months|Change in horizontal ridge width (RΔHD).||millimeters||Standard Deviation|Mean
737|NCT02602223|Primary|Post Operative Pain|A visual Analog score (VAS) pain scale form (scale of 1 to 10) will be provided with instructions to record pain levels on both surgical sites every day for 2-weeks post-surgery. VAS score of 10 indicates highest level of pain and 0 indicates no pain. Subjects will also asked to log any pain medications taken in that 2-week period. Subjects will be seen at 1&2 weeks for post-operative evaluation and VAS forms will be collected. Data will be reported as Average VAS score.|0-2 weeks|VAS score at 24 hours post operative||Units on a scale of 10||Standard Deviation|Mean
738|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3.5(±0.5)-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. Cores will be process and embedded in polymethylmethacrylate and sectioned to 5μm thickness and sections will be stained with Goldener’s Trichrome. With the Goldener’s trichrome, mineralized bone appears as green or blue regions, osteoid appears orange–red, nuclei appears blue-grey and graft remnants appear grey. Additional differentiation between graft and new bone will be achieved by morphologically assessing each sample individually. A slide scanner will be used to image the sample (20x magnification), and a software program will be used for the histomorphometric analysis, to quantify the amount of total mineralized bone, new bone / osteoid, soft tissue, and residual graft remnants in percentages .|3-4 months|New bone/osteoid Percentages||Percentage of New bone||Standard Deviation|Mean
739|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. A high-resolution microtomographic scanner will be used and images will be scanned at a voxel size of 8µm3. Moist bone cores will be wrapped in paraffin and scanned in air. Cores will be rotated in 0.7 degree increments with 450milli second time exposition. A 0.5m aluminum filter will be used to remove image noise. After scanning, 3D microstructural image data will be reconstructed using software. Structural indices will be calculated using a software. The micro-architectural variables; bone volume density (BV/TV), and bone surface density (BS/BV); will be quantified and reported as percentages.|3-4 month|The micro-architectural variable; bone volume density (BV/TV),was quantified and is reported as percentages.||Percentage of BV/TV||Standard Deviation|Mean
740|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures|A radiographic stent will be fabricated with reproducible access holes ≈5 mm apical to the mid-facial and mid-lingual gingival margin of the teeth to be extracted. On day of surgery, a calibrated examiner masked to treatment allocation, will record initial clinical bucco-lingual (iCBL) ridge measurements in millimeters (mm), through the access holes in the stent, using calipers. Approximately 3.5(±0.5)-months post extractions, the calibrated examiner masked to treatment allocation, will record the final clinical bucco-lingual (fCBL) ridge measurements in mm using the calipers as described earlier. The difference between fCBL and iCBL will be calculated as change in clinical horizontal ridge width dimensions in mm (cΔHD).|3-4 months|change in clinical horizontal ridge width dimensions in mm - cΔHD||millimeters|Participants|Standard Deviation|Mean
741|NCT02598934|Secondary|"Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6"|The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from ‘Not At All Confident’ to ‘Very Confident.’ A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.|Month 6|ITT population||percentage of participants|||Number
742|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)|Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
743|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
800|NCT02590562|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population||swollen joint count||Standard Deviation|Mean
43221|NCT01413516|Secondary|Nicotine Withdrawal and Urges to Smoke||4 weeks||12/2016||||
745|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)|Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
746|NCT02598934|Primary|Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)|Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.||percent change||Standard Deviation|Mean
747|NCT02598622|Primary|Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.||Days 1 - 21|Only 2 out of 8 participants were able to complete protocol related therapy and therefore no data were collected for analysis.|||||
748|NCT02598128|Other Pre-specified|Ease of Use of RELiZORB (Per-Protocol Population)|Effect of enteral nutrition on select activities of daily living. Patients judged the size of breakfast after overnight enteral tube feeding with the following choices: No breakfast; Small breakfast; Normal breakfast; Big breakfast; Other.|Period C: Single assessment on Day 19 or 20|Per Protocol Population.||Participants|||Count of Participants
749|NCT02598128|Primary|Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)|AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours|Day 1 first intervention and Day 9 second intervention.|||ug*h/mL||Standard Deviation|Mean
750|NCT02598128|Primary|Number of Patients With Adverse Events and Unanticipated Adverse Device Effects|1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)|27 days|Safety Population||Participants|||Count of Participants
751|NCT02597855|Secondary|Best Corrected Visual Acuity|Best corrected visual acuity assessed at baseline, 3 months, and 6 months|baseline, 3 months, and 6 monthsc|Participants who were finished 6 months follow up period.||LogMAR||Standard Deviation|Mean
752|NCT02597855|Primary|Regression Rate of Polyp on Indocyanine Green Angiography|Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%.|3 months|Participants who were finished 6 months follow up period.||participants|||Number
753|NCT02597582|Secondary|Postoperative Injected Analgesic Amount|The amount of injected form analgesic used (Meperidine 50 mg/ampule)|2 weeks|||Ampule||Standard Deviation|Mean
754|NCT02597582|Secondary|Postoperative Oral Analgesic Consumption|The amount of analgesic consumption via oral ingestion after operation|2 weeks|||capsules||Standard Deviation|Mean
755|NCT02597582|Secondary|Postoperative Subjective Pain Status|Visual analogue scale of subjective pain status after operation|2 weeks|Pain visual analogue scale (VAS) (no pain: 0, intolerable pain: 10)||units on a scale||Standard Deviation|Mean
756|NCT02597582|Secondary|Postoperative Drainage Amount|The amount of drainage from closed system drainage tube|2 weeks|||ml||Standard Deviation|Mean
757|NCT02597582|Secondary|Intraoperative Blood Loss|Intraoperative blood loss was estimated by the sum of the volume in the suction bottle and the increased weight of wet gauzes containing blood after neck dissection.|1 day|||ml||Standard Deviation|Mean
758|NCT02597582|Primary|Opreation Duration|The duration from incision of cervial skin till the completion of lymph node dissection|1 day|||minutes||Standard Deviation|Mean
759|NCT02596958|Secondary|Overall Survival|Overall survival was defined as the time (months) between the start of therapy and the date of death.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here 'number of participants analyzed' = participants assessed for this outcome measure.||months||Standard Deviation|Mean
760|NCT02596958|Secondary|Percentage of Participants Who Died||Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
761|NCT02596958|Secondary|Progression Free Survival (PFS)|PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non­target lesions) or death. Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. PFS was estimated using Kaplan-Meier method.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||months||95% Confidence Interval|Median
762|NCT02596958|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion. PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
801|NCT02590562|Secondary|Number of Participants With Abnormal Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
5256|NCT02217878|Secondary|Time to Maximum Concentration (Cmax) for Ticagrelor and AR-C124910XX||12 hours||||||
763|NCT02596958|Secondary|Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades|ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
764|NCT02596958|Secondary|Percentage of Participants With Best Tumor Response Over Time|Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent [%] decrease in the sum of the longest diameter [LD] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD], in addition to no new target lesions). PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.||percentage of participants|||Number
765|NCT02596958|Secondary|Number of Cycles of Systemic Therapy|Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.||cycles||Standard Deviation|Mean
766|NCT02596958|Secondary|Percentage of Participants Who Withdrew or Modified Treatment|Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.||percentage of participants|||Number
767|NCT02596958|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs|ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it or not.||percentage of participants|||Number
768|NCT02596945|Secondary|Average Duration in Days Mircera Was Administered at a Stable Dose||Up to 9 months|MES population.||days||Standard Deviation|Mean
769|NCT02596945|Secondary|Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|MES population.||percentage of participants|||Number
770|NCT02596945|Primary|Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9).||percentage of participants|||Number
771|NCT02596620|Primary|Percentage of Participants With Successful Eradication of H. Pylori|Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.|Negative results of H.pylori 4 weeks after eradication|||percentage of eradication||95% Confidence Interval|Number
772|NCT02595502|Primary|Overall Comfort|Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|1 Week|The analysis population consists of subjects that completed the study without a major protocol deviation.||units on a scale|Participants|Standard Deviation|Mean
773|NCT02595450|Secondary|Overall Survival (OS) Time|Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.|Up to 6 years|As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.||months||Full Range|Median
802|NCT02590562|Secondary|Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mmol/L||Standard Deviation|Mean
803|NCT02590562|Secondary|Number of Participants With Abnormal Triglyceride Values|Normal range for triglyceride is <1.7 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
804|NCT02590562|Secondary|Triglyceride Values|Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mmol/L||Standard Deviation|Mean
5257|NCT02217878|Secondary|Maximum Concentration (Cmax) of Ticagrelor and AR-C124910XX||12 hours||||||
774|NCT02595450|Primary|Percentage of Participants With Best Overall Response|Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported.||percentage of participants|||Number
775|NCT02595450|Primary|Progression-free Survival (PFS) Time|Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles.||months||95% Confidence Interval|Median
776|NCT02594826|Secondary|Knowledge About Cervical Cancer|"Women's knowledge will be measured using a true/false scale. Responses will be combined to form a knowledge score.~Analysis of secondary outcome data is ongoing."|12 months||10/2017||||
777|NCT02594826|Primary|Number of Women Who Receive a Pap Smear Test|Number of women who receive a Pap smear test in each group|12 months|||participants|||Number
778|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.||Three months.|Bellow concentration data of LDL-C was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
779|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.||Three months.|Bellow concentration data of TG was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
780|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.||Three months.|Bellow concentration data of TC was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
781|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.||Three months.|Below concentration data of FFA was after treatment with oral melatonin 2 weeks.||umol/L||Standard Deviation|Mean
782|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.||Three months.|Bellow concentration data of Glu was after treatment with oral melatonin 2 weeks.||mmol/L||Standard Deviation|Mean
783|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.||Three months|Bellow concentration data of Fbg was after treatment with oral melatonin 2 weeks.||g/L||Standard Deviation|Mean
784|NCT02591056|Primary|Change in Combined Circumference Measurements|Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.|Baseline and 6 Weeks|||inches||Standard Deviation|Mean
785|NCT02590562|Secondary|Participant's Pain Assessment|Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||cm||Standard Deviation|Mean
786|NCT02590562|Secondary|Participant’s Fatigue Assessment|Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||cm||Standard Deviation|Mean
787|NCT02590562|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from “no difficulty” to “unable to do”, corresponding to scores from 0 to 3. HAQ total score = sum of each of the 20 items' scores, with a summary score ranging from 0 to 60, where higher score indicates greater disability.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
788|NCT02590562|Secondary|Patient’s Global Assessment (PtGA) of Disease Activity|PtGA of disease activity was measured on a 0 to 10 cm VAS, with 0 cm = very well controlled and 10 cm = very poorly controlled.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||cm||Standard Deviation|Mean
789|NCT02590562|Secondary|Physician’s Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 10 centimeter (cm) VAS, with 0 cm = no disease activity and 10 cm = extreme disease activity.|Day 1 (enrollment visit)|Overall Population||cm||Standard Deviation|Mean
805|NCT02590562|Secondary|Number of Participants With Positive Rheumatoid Factor (RF)|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Central lab was not used in this study; the definitions of positive RF followed participating hospitals’ standardized criteria. CRF collected data as “positive” or “negative” directly.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
2837|NCT02368314|Secondary|Frequency of “Big” and Clinically Significant “Small” Bleedings||During the treatment period (14 days)||||||
790|NCT02590562|Secondary|DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
791|NCT02590562|Secondary|DAS28 by Duration of Treatment of Biological Agent|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure in respective arms.||units on a scale||Standard Deviation|Mean
792|NCT02590562|Secondary|Number of Participants With Duration of Treatment of Biological Agent|Number of participants with duration of treatment of biological agent <3 months, >= 3 to <6 months, >= 6 to <12 months, and >= 12 months.|Day 1 (enrollment visit)|Overall Population||participants|||Number
793|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
794|NCT02590562|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
795|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
796|NCT02590562|Secondary|Clinical Disease Activity Index (CDAI) Scores|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician’s Global Assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
797|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
798|NCT02590562|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and Patient’s Global Assessment (PtGA) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
992|NCT02567188|Primary|Mean Hb Value at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
806|NCT02590562|Secondary|Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody|ACCP antibodies are important markers of bone erosion in RA. Central lab was not used in this study; the definitions of positive ACCP followed participating hospitals’ standardized criteria. CRF collected data as “positive” or “negative” directly.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
807|NCT02590562|Secondary|Number of Participants With Anemia|Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
808|NCT02590562|Secondary|Hemoglobin Values|Hemoglobin levels were measured in gram per liter (g/L). Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||g/L||Standard Deviation|Mean
809|NCT02590562|Secondary|Number of Participants With Abnormal ESR Values|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. Central lab was not used in this study; the definitions of abnormal ESR followed participating hospitals’ standardized criteria. CRF collected data as directly “normal” or “abnormal”.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
810|NCT02590562|Secondary|Erythrocyte Sedimentation Rate (ESR) Values|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mm/hr||Standard Deviation|Mean
811|NCT02590562|Secondary|Number of Participants With Abnormal CRP Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Central lab was not used in this study; the definitions of abnormal CRP followed participating hospitals’ standardized criteria. Case report form (CRF) collected data as directly “normal” or “abnormal”.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
812|NCT02590562|Secondary|C-Reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
813|NCT02590562|Secondary|Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
814|NCT02590562|Secondary|Number of Participants With Concurrent RA Extra-articular Symptoms|Number of participants with concurrent RA extra-articular symptoms including RA subcutaneous nodule, RA vasculitis, interstitial pneumonia, Felty’s syndrome, and other symptoms were presented. One participant could have more than one concurrent RA extra-articular symptoms.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
815|NCT02590562|Secondary|Number of Participants With RA Duration|Number of participants with RA duration of <= 6 months, >6 months and <= 3 years, >3 years and <= 10 years, and 10 years.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
816|NCT02590562|Secondary|RA Duration Since Diagnosis|RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||years||Standard Deviation|Mean
817|NCT02590562|Secondary|Number of RA Related Operations|RA related operations also included prosthesis.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||RA related operations||Standard Deviation|Mean
818|NCT02590562|Secondary|Height||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||centimeters (cm)||Standard Deviation|Mean
819|NCT02590562|Secondary|Weight||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||kilograms||Standard Deviation|Mean
820|NCT02590562|Secondary|Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage||Day 1 (enrollment visit)|Overall Population||participants|||Number
821|NCT02590562|Primary|Average Daily Dose of Each Previously Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||mg/day||Standard Deviation|Mean
822|NCT02590562|Primary|Average Daily Dose of Each Currently Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||mg/day||Standard Deviation|Mean
823|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||weeks||Standard Deviation|Mean
824|NCT02590562|Primary|Average Weekly Dose of Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||mg/week||Standard Deviation|Mean
2838|NCT02368314|Secondary|Frequency of Venous Thromboembolism (PATE and/or DTV)||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
825|NCT02590562|Primary|Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs|Number of participants using one concomitant csDMARD, two concomitant csDMARDs (methotrexate + hydroxychloroquine [HCQ], methotrexate + salazosulfapyridine [SASP], methotrexate+ leflunomide, SASP + HCQ, and other combinations), or three (or more) concomitant csDMARDs (methotrexate + SASP + HCQ, and other combinations) are presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
826|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant External Medicine||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.||weeks||Standard Deviation|Mean
827|NCT02590562|Primary|Average Weekly Dose of Each Concomitant Glucocorticoid|Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone [BMZ] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified concomitant glucocorticoid treatment.||mg/week||Standard Deviation|Mean
828|NCT02590562|Primary|Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past|Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
829|NCT02590562|Primary|Number of Participants With Previous Use of the Same Biological Agent|Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment.|Day 1 (enrollment visit)|Overall Population||participants|||Number
830|NCT02590562|Primary|Average Duration of Treatment for Each Biological Agent|Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. n = participants with specified treatment of biological agent.||weeks||Standard Deviation|Mean
831|NCT02590562|Primary|Average Weekly Dose of Treatment for Each Biological Agent|Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified treatment of biological agent.||milligrams (mg) per week||Standard Deviation|Mean
832|NCT02590562|Primary|Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents|Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
833|NCT02590562|Primary|Number of Participants Receiving a Biological Agent Concomitant With Other Drugs|Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine.|Day 1 (enrollment visit)|Overall Population||participants|||Number
834|NCT02590562|Primary|Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs [NSAIDs], and biological agent + glucocorticoid + NSAIDs.|Day 1 (enrollment visit)|Overall Population||participants|||Number
835|NCT02588599|Secondary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 6 months after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 6 Months|Each participant in this study had only one great toenail treated.||millimeters|Participants|Standard Deviation|Mean
836|NCT02588599|Primary|Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|6 Months|Each participant had only one great toenail treated in this study.||Percent of Toenails|Participants||Number
837|NCT02587819|Post-Hoc|Change in Lesion Size.|BCC lesion area was measured at Baseline and after 28 days treatment. Percantage change in lesion area was caculated.|28 days|Final area of lesion was not recorded for one subject.||percentage change in tumour area||Standard Error|Mean
838|NCT02587819|Primary|Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.|The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).|8 weeks|Anti sheep IgG antibody titres were measured from 21 subjects at screening and baseline, 20 subjects at Visit 6 (Day 29 EOT) and 19 subjects at Visit 8 (Day 57 follow up). The percentage of patients with detectable anti sheep antibodies is reported.||percentage of subjects|||Number
849|NCT02584686|Secondary|SEP-Q3 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) after treatment.~This analysis compares the number of patients who were able to maintain their erection long enough to complete sexual intercourse after treatment in the (BTX) A group versus the Saline group."|1 month|||participants|||Number
2839|NCT02368314|Secondary|Frequency of Death From Other Causes||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
839|NCT02587819|Primary|Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.|To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.|28 days|At all timepoints, the serum concentration of sheep IgG was too low to be quantified in most of the subjects. One subject had measurable sheep IgG at 1 hr post dose at Visit 6 (EOT) and 3 other subjects had measurable sheep IgG at predose timepoints. In outcome measure below NA represents readings less than lower limit of quantification.||ng/ml||Full Range|Median
840|NCT02587819|Primary|Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)|Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.|8 weeks|All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.||participants|||Number
841|NCT02587117|Secondary|Burning Sensation or Pain by Using NRS (Numerical Rating Scale)|Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score.|8 weeks minus baseline|||Scores on a scale||Standard Deviation|Mean
842|NCT02587117|Primary|Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score|Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion <1 cm2; score 2: lesion 1-3 cm2; score 3= lesion >3 cm2. Ulceration: score 0= no lesion; score 1= lesion <1 cm2; score 2= lesion 1-3 cm2; score 3= lesion >3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 & 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome & zero value represent no lesion.|8 weeks minus baseline|||Scores on a scale||Standard Deviation|Mean
843|NCT02586506|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study|Participants’ ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 28|mITT Population||Percentage||95% Confidence Interval|Number
844|NCT02586506|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study|Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 28|mITT Population||Percentage||95% Confidence Interval|Number
845|NCT02586506|Primary|The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study.|Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution.|Day 28|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2.||Percentage||95% Confidence Interval|Number
846|NCT02586493|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study.|Participants’ ability to correctly use the ELLIPTA inhaler was assessed at Visit 1 and Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 30|mITT Population||Percentage of Participants||95% Confidence Interval|Number
847|NCT02586493|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study.|Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 30|mITT Population||Percentage of Participants||95% Confidence Interval|Number
848|NCT02586493|Primary|Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate Correct Use of the Inhaler at the End of the Study.|Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised).|Day 30|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2. Only participants with data available at the analysis time point were analyzed.||Percentage||95% Confidence Interval|Number
850|NCT02584686|Secondary|SEP-Q3 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) before treatment."|Baseline|||participants|||Number
851|NCT02584686|Secondary|SEP-Q2 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?) after treatment.~This analysis compares the number of patients who were able to perform vaginal intromission (insert the penis into the partner’s vagina) after treatment in the (BTX) A group versus the Saline group."|1 month|||participants|||Number
852|NCT02584686|Secondary|SEP-Q2 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?)"|Baseline|||participants|||Number
853|NCT02584686|Secondary|Global Assessment Question (GAQ)|"Assessment of the effect of treatment by asking Has the treatment you have been taking improved your erectile function?. The number answering Yes in both the treatment and control groups are calculated."|1 month|||participants|||Number
854|NCT02584686|Secondary|SHIM Score After Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|1 month|||units on SHIM scale||Standard Deviation|Mean
855|NCT02584686|Secondary|SHIM Score Before Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|Baseline|||units on the SHIM scale||Standard Deviation|Mean
856|NCT02584686|Secondary|EHS After Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI after 2 weeks.~The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).~0 – Penis does not enlarge.~– Penis is larger, but not hard.~– Penis is hard, but not hard enough for penetration.~– Penis is hard enough for penetration, but not completely hard.~– Penis is completely hard and fully rigid. The average score is reported for each group."|2 weeks|||units on EHS scale||Standard Deviation|Mean
857|NCT02584686|Secondary|EHS Before Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI at baseline.~The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).~0 – Penis does not enlarge.~– Penis is larger, but not hard.~– Penis is hard, but not hard enough for penetration.~– Penis is hard enough for penetration, but not completely hard.~– Penis is completely hard and fully rigid. The average score is reported for each group."|Baseline|||units on EHS scale||Standard Deviation|Mean
858|NCT02584686|Primary|Cavernosal Artery Mean PSV After Treatment|Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.|2 weeks|||cm/s||Standard Deviation|Mean
859|NCT02584686|Primary|Cavernosal Artery Mean PSV Before Treatment|Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups, before treatment.|Baseline|||cm/s||Standard Deviation|Mean
860|NCT02582983|Primary|Number of Participants With Premature Withdrawal Due to Adverse Events||Up to 96 weeks|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.||participants|||Number
861|NCT02582983|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe."|Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.||participants|||Number
862|NCT02581475|Secondary|Adenomas Per Patient in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.|||adenomas per patient||Standard Deviation|Mean
863|NCT02581475|Secondary|Duration of the Total Colonoscopy Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.|||minute||Standard Deviation|Mean
864|NCT02581475|Secondary|Withdrawal Time in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.|||minute||Standard Deviation|Mean
865|NCT02581475|Primary|Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.|Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.|During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.|||proportion of participants||95% Confidence Interval|Number
866|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population.||kappa coefficient|||Number
877|NCT02580799|Secondary|Percentage of Participants With Pathological Grade|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular, Nuclear and Mitosis scoring pattern was discussed in outcome 11, each score was added to give a final total score ranging from 3-9. Tumors with 3, 4 or 5 points are classified as being of low malignancy or Grade I, those with 6 or 7 points of intermediate malignancy or Grade II, and those with 8 or 9 points of high malignancy or Grade III.|Up to 70 days|FAS population.||percentage of participants|||Number
867|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. n included the number of participants evaluable for the specified category."||percentage of participants|||Number
868|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||kappa coefficient|||Number
869|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
870|NCT02580799|Secondary|Percentage of Participants With Different IHC Results|"The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it’s called “HER2 negative.” If the score is 2+, it's called borderline. A score of 3+ is called “HER2 positive.” Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells."|Up to 70 days|FAS population.||percentage of participants|Participants||Number
871|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Primary Antibody|The primary antibodies included; Biocabe EP 10454, Cerb B2 (SP3 clone), Her2 Neu (SP3) Cell marque, Neomarkers (thermo) cerb B2-Ab-17 and Thermo SP3.|Up to 70 days|FAS population.||percentage of participants|Participants||Number
872|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Antigen Retrieval|Fixation of tissue samples cross-link proteins and masks antigenic sites; antigen retrieval process was performed before IHC staining in order to reverse the masking of antigenic sites. Antigen retrieval process was performed in this study using the following solutions: 1 hour Cell Conditioning 1 (CC1), 30 minutes (min) CC1 mild, 64 min CC1, CC1 Ethylenediaminetetraacetic acid (EDTA) standard, and Cell Conditioning 2 (CC2) 30 min.|Up to 70 days|FAS population.||percentage of participants|Participants||Number
873|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Different Automated Slide Stainers|Different slide stainers like Ventana, Ventana Benchmark 4XT, Ventana Benchmark Ultra and Ventana Benchmark XT were used to report HER2 test results on data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site).|Up to 70 days|FAS population.||percentage of participants|Participants||Number
874|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Country|Reference site was considered as Abroad and the tests were performed in a laboratory in Amsterdam, Netherlands. A total of 150 data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site) were collected.|Up to 70 days|FAS population.||percentage of participants|Participants||Number
875|NCT02580799|Secondary|Percentage of Participants With Specified Density of Hormone Receptors|The specific density of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||percentage of participants|||Number
876|NCT02580799|Secondary|Percentage of Participants With Different Hormone Receptors|Presence of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||percentage of participants|||Number
899|NCT02576535|Primary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms||10 years|||participants|||Number
878|NCT02580799|Secondary|Percentage of Participants With Pathological Score|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular score (TS) 1: >75 percent (%) of tumor area forming tubular structures, TS 2: 10% to 75% of tumor area forming tubular structures, TS 3: <10% of tumor area forming tubular structures. Nuclear score (NS) 1: nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size, NS 2: cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape, NS 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. Mitosis score (MS) 1: ≤7 mitoses per 10 high power fields, MS 2: 8-14 mitoses per 10 high power fields and MS 3: ≥15 mitoses per 10 high power fields.|Up to 70 days|FAS population.||percentage of participants|||Number
879|NCT02580799|Secondary|Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision|TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastasis (M). T1: tumor ≤20 millimeters (mm), T2: tumor >20 mm to ≤50 mm, T3: >50 mm and TX: tumor cannot be assessed. N0: no lymph node metastasis, N1: metastasis to ipsilateral level I, II axillary lymph nodes, N2: N1 metastasis that is clinically fixed/matted or in clinically detected ipsilateral internal mammary nodes, N3: metastases in ipsilateral infraclavicular lymph nodes, with/without level I, II axillary node involvement, or in clinically detected ipsilateral internal mammary lymph nodes and clinically evident level I, II axillary lymph node metastasis; or metastasis in ipsilateral supraclavicular lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastasis, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm, and MX: metastases cannot be assessed.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
880|NCT02580799|Secondary|Percentage of Participants With Diagnosis of Primary Tumor|Primary tumor diagnosis was classified into invasive ductal carcinoma, invasive ductal carcinoma + integrin linked kinase (ILK) antibody and mixed (invasive ductal + lobular) and reported.|Up to 70 days|FAS population.||percentage of participants|||Number
881|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Site B and Others (Sites C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||kappa coefficient|||Number
882|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
883|NCT02580799|Primary|Kappa Coefficient (K) as a Measure of Agreement Between Site A and Others (Sites B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values were interpreted as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.||kappa coefficient|||Number
884|NCT02580799|Primary|Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."||percentage of participants|||Number
885|NCT02578992|Secondary|Visual Analog Scale of Sore Throat|"All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.~Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome."|after anesthesia emergence 30 minutest, at post-anesthesia care unit|||units on a scale||Full Range|Mean
886|NCT02578992|Secondary|Mean Arterial Pressure|compare the mean arterial pressure between two groups.|before and after intubation, up to 5 minutes|||mmHg||Standard Deviation|Mean
900|NCT02576535|Secondary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms||10 years|||participants|||Number
2840|NCT02368314|Secondary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
887|NCT02578992|Secondary|Modified Cormack–Lehane Grade|"The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.~Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome."|during intubation, after epiglottis was identified on the video monitor|||units on a scale||Full Range|Mean
888|NCT02578992|Primary|Intubation Time|the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.|from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts|||seconds||Inter-Quartile Range|Median
889|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
890|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
891|NCT02577315|Primary|Maximum Measured Concentration of the Metformin in Plasma (Cmax)|Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
892|NCT02577315|Primary|Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)|Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
893|NCT02577315|Primary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.||nanogram (ng)*h /millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
894|NCT02577315|Primary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from treated set (TS) who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Subject was included, even if he/she contributed only 1 PK value for one period.||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
895|NCT02576535|Post-Hoc|Number of Participants Experiencing Seizures||10 years|||participants|||Number
896|NCT02576535|Primary|Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography||10 years|||participants|||Number
897|NCT02576535|Primary|Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)||10 years|||participants|||Number
898|NCT02576535|Primary|Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities||10 years|||participants|||Number
901|NCT02576145|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to Month 12|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
902|NCT02576145|Secondary|Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization|DTH skin reactions were assessed 48 hours after each KLH immunization given on Day 1 and on Day 29. A positive response was defined as an induration >=5 mm.|Day 1 and Day 29|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
903|NCT02576145|Secondary|Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response|Nonresponders (participants who failed to mount antibody responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive antibody response to KLH was defined as at least a 2-fold increase in antibody concentration at any time point up to Day 252 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH Antibody nonresponders were evaluated.||participants|||Number
904|NCT02576145|Secondary|Percentage of Participants With Positive Antibody Response to KLH Immunization at Month 6|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on Month 6 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA). Due to the small number of participants enrolled in the study, percentage of participants with positive antibody response to KLH immunization at Month 6 was not reported.|Month 6||||||
905|NCT02576145|Secondary|Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+|Blood samples were obtained for flow activated cell sorter (FACS) analyses of HLA-DR+, CD45RO+ and CD45RA+ on Days 1, 29, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 29 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.Only participants with data available at a particular time point were analyzed.||Percent expression||Standard Deviation|Mean
906|NCT02576145|Secondary|Mean Percent Expression of CD3, CD4, and CD8|Blood samples were obtained for flow activated cell sorter (FACS) analyses of T cell subsets (CD3, CD4, and CD8) on Days 1, 22, 29, 43, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 22, 29, 43 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.||Percent expression||Standard Deviation|Mean
907|NCT02576145|Secondary|Mean Percent Expression of 2A3/CD25+ Antibody|CD25 is an antigen that is present on a subset of peripheral blood lymphocytes. The expression of CD25+ on T cell was investigated using antibody 2A3. Blood samples were drawn for evaluation of CD25+ at screening and on Days 29, 57, and 168.|Screening, Day 29, Day 57 and Day 168|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.||Percent expression||Standard Deviation|Mean
908|NCT02576145|Secondary|Geometric Mean Antibody Concentrations for KLH (IgM and IgG) and TT (IgG)|Due to the small number of participants enrolled in the study, geometric means at Baseline and on Days 22, 29, 43 and 57 were not reported.|Screening, Day 22, Day 29, Day 43 and Day 57||||||
909|NCT02576145|Secondary|Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response|Nonresponders (participants who mount humoral responses but no cellular responses to tetanus vaccination) were rechallenged with TT 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to TT was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, at any time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were tetanus cellular nonresponders were evaluated.||participants|||Number
910|NCT02576145|Secondary|Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization|Nonresponders (participants who failed to mount cellular responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to KLH was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH cellular nonresponders were evaluated.||participants|||Number
911|NCT02576145|Secondary|Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
912|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)|Positive cellular response was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
913|NCT02576145|Secondary|Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)|Humoral response to TT was defined as >=1.5 fold increase in antibody concentration from baseline in participants with protective anti-TT IgG level >=0.1 IU/mL. All humoral responses were assessed by ELISA.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
914|NCT02576145|Secondary|Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
915|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to KLH Immunization|Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43, and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.||participants|||Number
916|NCT02576145|Primary|Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 43 or Day 57|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses and had Day 43 and 57 assessments were included in this population.||participants|||Number
917|NCT02576041|Secondary|Time to Reaction Evaluated During the F1 Simulator|During the test, at different times, the patient will be requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions will be registered.|7±3 days of active treatment|Adult outpatient of eighter sex affected by Allergic Rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).||msec||Standard Deviation|Mean
918|NCT02576041|Secondary|Maintenance of Constant Speed Evaluated During the F1 Simulator|Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.|7±3 days of active treatment|The study included adult outpatient of either sex,affected by Allergic Rhinitis (seasonal or perennial) and/or Chronic Urticaria (induced or not induced),able to perform a preliminary driving test on F1-high speed simulator without experiencing signs or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness, etc).||Km/h||Standard Deviation|Mean
919|NCT02576041|Primary|Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test|SDLP (mainly assessing attention capacities). This is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered.|7+3 days of active treatment|The study included adult outpatient of either sex affected by allergic rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).||meters||Standard Deviation|Mean
920|NCT02574845|Secondary|Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞)|This outcome measure presents area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
921|NCT02574845|Primary|Maximum Concentration of Rosuvastatin (Cmax)|This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
922|NCT02574845|Primary|Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)|This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|The pharmacokinetic (PK) parameter set (PKS) includes all randomised subjects who took at least one dose of study medication and provided at least one primary or secondary PK parameter that was not excluded from analysis due to non-evaluability or protocol violation relevant for the evaluation of the pharmacokinetics.||nanomol (nmol) * hour (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
923|NCT02574260|Secondary|Number of Participants Alive at the Time of Study Discontinuation or Completion||At end of study, median duration of treatment was 267 days|||participants|||Number
924|NCT02574260|Secondary|Number of Participants With an Objective Response|"Objective response is defined as participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST).~Responses must have been confirmed two visits not less than 4 weeks apart.~Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:~Complete response (CR): zero tumor burden~Partial response (PR): a 30% or greater decrease in tumor burden~Progressive disease (PD): a 20% or greater increase in tumor burden~Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|Every 12 weeks from the start of therapy in this extension protocol, or 12 weeks from the last assessment in the 002/03 protocol (whichever date is later) through 30 days after administration of the last dose; median duration of treatment was 267 days.|||participants|||Number
925|NCT02574260|Primary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).~Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From the first dose of talimogene laherparepvec in Study 002-03-E and within 30 days of the last dose; median duration of treatment was 267 days.|||participants|||Number
926|NCT02572752|Secondary|AUC0-inf|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
927|NCT02572752|Primary|Cmax|Maximum measured concentration of the analyte in plasma (Cmax). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
928|NCT02572752|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference treatment 1 (R1) and Reference treatment 2 (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|Pharmacokinetic Set (PKS) : This analysis set included all treated subjects who provided at least 1 observation for at least 1 primary endpoint, and who had no important protocol violations impacting statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
929|NCT02572609|Primary|AUC0-t|Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ).|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|PK set||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
930|NCT02572609|Primary|Cmax|Maximum plasma concentration achieved|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|The pharmacokinetic set (PK Set): 36 subjects provided 1 evaluable value of reference product and 1 evaluable value of test product for the primary PK endpoints (Cmax and AUC0-t) without important protocol violations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
931|NCT02572427|Secondary|Knowledge Concerning Intubation of Neonates|Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).|30 minutes|||scores on a scale||Standard Deviation|Mean
932|NCT02572427|Primary|Skill in Intubating Neonatal Manikin|Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab|Up to two minutes|||seconds||Standard Deviation|Mean
933|NCT02571634|Secondary|Sedation Level Assessed by POSS Tool|At baseline, 15 minutes post medication receipt, 30 minutes , 45 minutes and at discharge a Pasero-Opioid Sedation Scale Score was obtained. This scale is to measure alertness and amount of sedation. POSS was the abbreviated term used for this scale. The guidelines for that scale include: S= sleeping easily aroused 1= alert and awake; 2= slightly drowsy easily aroused; 3= frequently drowsy, drifts off to sleep during conversation; 4= somnolent, minimal or no response|Baseline, 15 min, 30 min, 45 min, discharge|||POSS sedation scores||Standard Error|Mean
934|NCT02571634|Secondary|Adverse Events|Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.|24 hours|All 23 subjects were monitored with blood pressure, heart rate, oxygen saturation and sedation scores to determine any adverse events.||number of adverse events|||Number
935|NCT02571634|Secondary|Patient Satisfaction Using a Likert Satisfaction Survey|At 24 hour after the procedure a call was made asking the volunteer to provide a number on a scale to describe their satisfaction with their pain control and their overall satisfaction. A 5 point likert scale was used 1 = very satisfied, 2 satisfied, 3 neither satisfied nor dis-satisfied, 4 not satisfied and 5 very unsatisfied.|24 hours|Subjects were asked about pain control satisfaction and overall satisfaction using a 5 point likert scale. 1 = very satisfied, 2= satisfied, 3= neither satisfied nor dis-satisfied, 4= not satisfied and 5 = very unsatisfied||Units on scale||Standard Deviation|Mean
993|NCT02567188|Primary|Mean Hb Value at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
936|NCT02571634|Secondary|Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.|DVPRS pain scores will be recorded baseline and at 15 minutes post dosing, 30 minutes, 45 minutes and discharge. The DVPRS is a pain scale utilizing color coding descriptive terms and faces to describe pain levels from 0 meaning no pain and 10 the most excruciating pain ever.|Baseline, 15 min, 30 min, 45 min, and discharge|||pain score||Standard Error|Mean
937|NCT02571634|Primary|Safety and Tolerability as Measured by the Number of Adverse Events|Adverse events will be recorded by a yes or no as to their occurence|24 hours|||adverse events|||Number
938|NCT02570425|Secondary|Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score|8 weeks|||percent of participants|||Number
939|NCT02570425|Secondary|Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score|4 weeks|||percent of participants|||Number
940|NCT02570425|Secondary|Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score|0 weeks (Visit 1)|||percent of participants|||Number
941|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants||8 weeks|||errors|||Number
942|NCT02570425|Secondary|Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants||4 weeks|||errors|||Number
943|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants||0 weeks (Visit 1)|||errors|||Number
944|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants|8 weeks|||errors|||Number
945|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants|4 weeks|||errors|||Number
946|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants|Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor|0 weeks (Visit 1)|||errors|||Number
947|NCT02570425|Secondary|The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor|Number of levels required to achieve device mastery out of a 6 level training processrequired by each patient at each visit as assessed by expert assessor|4 weeks|||levels||Standard Deviation|Mean
948|NCT02570425|Secondary|Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 8 weeks from baseline visit as assessed by expert assessor|8 weeks|||participants|||Number
949|NCT02570425|Secondary|Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 4 weeks from baseline visit as assessed by expert assessor|0 weeks (Visit 1)|||participants|||Number
950|NCT02570425|Secondary|Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process at baseline visit as assessed by expert assessor|0 weeks (Visit 1)|||participants|||Number
951|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks|||percent of participants|||Number
952|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks|||percent of participants|||Number
953|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks|||percent of participants|||Number
954|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks|||percent of participants|||Number
990|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Pre-baseline (Month -6) to Baseline|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between pre-baseline (Month -6) and baseline.||percentage of participants|||Number
955|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)|||percent of participants|||Number
956|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)|||percent of participants|||Number
957|NCT02570425|Primary|Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor|"Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices.~The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate."|4 weeks|||percent of participants|||Number
958|NCT02570022|Secondary|Morphine Equivalents|Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.|four days postoperatively|||mg of morphine equivalent||Standard Deviation|Mean
959|NCT02570022|Primary|Pain Levels|Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.|four days postoperatively|||units on a scale||Standard Deviation|Mean
960|NCT02569996|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis.||months||95% Confidence Interval|Mean
961|NCT02569996|Secondary|Duration of Response (DR)|Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis||months||95% Confidence Interval|Mean
962|NCT02569996|Secondary|Time to Next Anti-lymphoma Treatment (TTNLT)|Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
963|NCT02569996|Secondary|Time to Progression (TTP)|Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
964|NCT02569996|Secondary|Overall Survival (OS)|Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From randomization until death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
965|NCT02569996|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death|Up to 27 months|Safety population: All participants who received at least one dose of study medication and had safety data after the first dose of study drug.||participants|||Number
988|NCT02567188|Secondary|Percentage of Participants With Changes in Immunosuppressive Treatment|Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
966|NCT02569996|Primary|Event-free Survival|Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.|From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.||months||95% Confidence Interval|Mean
967|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
968|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
969|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
970|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
971|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
972|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
973|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||mg/L||Standard Deviation|Mean
974|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.||mg/L||Standard Deviation|Mean
975|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||mg/L||Standard Deviation|Mean
976|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
977|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 1st hour|||seconds||Standard Deviation|Mean
978|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||seconds||Standard Deviation|Mean
979|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 24th hour|All patients have gall bladder disease who are between 18-80 years old.||mg/dL||Full Range|Median
980|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 1 st hour|All patients have gall bladder disease who are between 18-80 years old.||mg/dL||Full Range|Mean
981|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.||mg/dL||Full Range|Mean
982|NCT02568852|Primary|Duration of Operation|group1 and group 2(Duration of Operation)|up to 2 hours|All patients have gall bladder disease who are between 18-80 years old.||minutes||Full Range|Mean
983|NCT02568345|Primary|Sugammadex ED90|"Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion.~The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion."|8 minutes|||mg/kg||99% Confidence Interval|Number
984|NCT02567188|Secondary|Percentage of Participants Who Required Renal Replacement Therapy|Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
985|NCT02567188|Secondary|Percentage of Participants Who Required Blood Transfusion||Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
986|NCT02567188|Secondary|Number of Participants With Different Medication Treatment|Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.|Pre-baseline (Month -6) to Month 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure.||participants|||Number
987|NCT02567188|Secondary|Percentage of Participants With Changes in AntihypertensiveTreatment|Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
989|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Baseline to Month 12|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between baseline and Month 12.||percentage of participants|||Number
994|NCT02567188|Primary|Mean Hb Value at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
995|NCT02567188|Primary|Mean Hb Value at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
996|NCT02567188|Primary|Mean Hb Value at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
997|NCT02567188|Secondary|Percentage of Participants With Changes in Iron Supplement|Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.||percentage of participants|||Number
998|NCT02567188|Secondary|Correlation of Hb Levels With Levels of Inflammation||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.|||||
999|NCT02567188|Secondary|Correlation of Hb Levels With Underlying Disease||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.|||||
1000|NCT02567188|Secondary|Percentage of Participants With Number of MIRCERA Dose Changes||Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with available data for this outcome measure.||percentage of participants|||Number
1001|NCT02567188|Secondary|Percentage of Participants With Change in MIRCERA Treatment|Change in MIRCERA treatment included changes in dose, frequency, and route of administration.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure. n = number of participants evaluable at the specified time frame.||percentage of participants|||Number
1002|NCT02567188|Primary|Mean Hb Value at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||gm/L||Standard Deviation|Mean
1003|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
1004|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
1005|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
1006|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
1007|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
1008|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
1009|NCT02567188|Primary|Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.||percentage of participants|||Number
1010|NCT02563834|Secondary|Myocardial Perfusion Rate|PET measure of total myocardial perfusion (blood flow)|4 Hours|||ml/min/100g||Standard Error|Mean
1011|NCT02563834|Secondary|Myocardial Oxidation Rate|PET measure of total oxidation rate|4 Hours|||ml/min/100g||Standard Error|Mean
1012|NCT02563834|Primary|Myocardial Fatty Acid Uptake Rate|PET measure of fatty acid uptake rate|4 Hours|||umol/min/100g||Standard Error|Mean
1013|NCT02563093|Secondary|Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
1014|NCT02563093|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Participants|||Number
1015|NCT02563093|Secondary|Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination.|Day 0 (Pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Participants|||Number
1016|NCT02563093|Secondary|Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1017|NCT02563093|Primary|Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|"Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.~A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set."|Day 0 up to Day 7 post-vaccination|The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to < 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) group in the Safety Analysis Set.||Participants|||Number
1018|NCT02561572|Secondary|Pain Score||24 h postop|Unable to collect data on wards after PACU discharge.|||||
1019|NCT02561572|Secondary|Pain Score in the Postanaesthetic Care Unit (PACU)|The number of patients experiencing moderate/severe pain in PACU.|Immediately postop|||Participants|||Count of Participants
1020|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV)||24 h postop|Unable to collect data on wards after discharge from PACU|||||
1021|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)||Immediately postop|||Participants|||Count of Participants
1022|NCT02561572|Secondary|Amsterdam Preoperative Anxiety and Information Scale Scores|The Amsterdam Pre-operative Anxiety and Information Scale has four questions relating to anxiety (APAISa, Table 2) and has been shown to correlate well with the full version of the State-Trait Anxiety Inventory. The scores from the anxiety elements of the questionnaire are added together giving a possible of total score of 4 (low anxiety) to 20 (high anxiety).|30 minutes after intervention|||units on a scale||Inter-Quartile Range|Median
1023|NCT02561572|Primary|State-Trait Anxiety Inventory Score|Patients completed the six item short form of the State-Trait Anxiety Inventory (STAI-S6) in order to assess baseline anxiety levels prior to any intervention. The STAI-S6 is a standardised short form of the 40-item Spielberger State-Trait Anxiety Inventory that has three anxiety-present and three anxiety-absent questions (Table 1). Scores from the STAI-S6 are prorated up to allow comparison with the full version of the questionnaire, with scores ranging from 20 (low anxiety) to 80 (high anxiety). The STAI-S6 has been shown to correlate well with the full version, [12] but is much quicker for participants to complete.|30 minutes after intervention|||units on a scale||Inter-Quartile Range|Median
1024|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
1025|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
1026|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.|Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
1048|NCT02555618|Secondary|Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)|Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.||percentage of participants|||Number
1027|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
1028|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.||percentage of participants|||Number
1029|NCT02557646|Secondary|Percentage of Participants With SVR According to IL-28B Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1030|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1031|NCT02557646|Secondary|Percentage of Participants With SVR According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1032|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population.||percentage of participants|||Number
1033|NCT02557646|Secondary|Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1034|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1108|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1035|NCT02557646|Secondary|Percentage of Participants With SVR According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1036|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1037|NCT02557646|Secondary|Percentage of Participants With Virologic Response|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.|Week 4, 12, 24 and at EOT (maximum up to 72 weeks)|ITT Population.||percentage of participants|||Number
1038|NCT02557646|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin|Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||percentage of participants|||Number
1039|NCT02556307|Secondary|Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin||Up to 99.6 Weeks|All treated participants were included.||weeks||Standard Deviation|Mean
1040|NCT02556307|Secondary|Hemoglobin Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for hemoglobin. Here, n specifies number of participants with data available for specified category."||gram per liter||Standard Deviation|Mean
1041|NCT02556307|Secondary|Leukocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for leukocyte value. Here, n specifies number of participants with data available for specified category."||billion cells per liter||Standard Deviation|Mean
1042|NCT02556307|Secondary|Thrombocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for thrombocyte value. Here, n specifies number of participants with data available for specified category."||billion cells per liter||Standard Deviation|Mean
1043|NCT02556307|Secondary|HCV RNA Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for HCV RNA. Here, n specifies number of participants with data available for specified category."||IU/mL||Standard Deviation|Mean
1044|NCT02556307|Secondary|Percentage of Participants With Undetectable HCV RNA|Undetectable HCV RNA=a single last HCV RNA <20 IU/mL|Weeks 4, 12 and at end of treatment (up to 99.6 weeks)|All treated participants were included in the analysis.||percentage of participants|||Number
1045|NCT02556307|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment|SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).|6 months after the last study drug administration (up to 123.6 weeks)|All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).||percentage of participants|||Number
1046|NCT02555618|Secondary|Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs|The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.||percentage of participants|||Number
1047|NCT02555618|Secondary|Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|22 days|Safety Analysis Set included all participants who received vaccination with study vaccine.||percentage of participants|||Number
1109|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1049|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
1050|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1051|NCT02555618|Secondary|GMT of SRH Antibody Titer (Vero-Derived Antigen)|GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||titer||95% Confidence Interval|Geometric Mean
1052|NCT02555618|Secondary|Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1053|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
1054|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1055|NCT02555618|Secondary|GMT of HI Antibody Titer (Vero-Derived Antigen)|GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||titer||95% Confidence Interval|Geometric Mean
1056|NCT02555618|Secondary|Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of <10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1057|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
1058|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1059|NCT02555618|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||mm^2||95% Confidence Interval|Geometric Mean
1060|NCT02555618|Secondary|Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1110|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1061|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||fold increase||95% Confidence Interval|Geometric Mean
1062|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1063|NCT02555618|Primary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||titer||95% Confidence Interval|Geometric Mean
1064|NCT02555618|Primary|Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|"Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.~Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10."|Baseline and Day 22|Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.||percentage of participants||95% Confidence Interval|Number
1065|NCT02555228|Secondary|Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution||Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours|||number of events|||Number
1066|NCT02555228|Secondary|Volume of Additional Manual Flushes Required During Endoscopy in Mls|The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.|||mls||Standard Deviation|Mean
1067|NCT02555228|Secondary|Mucosal Visibility Score Per Area as Determined by Mc Nally Score:|"Area E: esophagus~Area D: duodenum~Area A: antrum and angularis~Area B: body and fundus~Mc Nally score per area:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.|||units on a scale||Standard Deviation|Mean
1068|NCT02555228|Primary|Total Cumulative Mucosal Visibility Score|"Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured~Total areas covered:~(E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.|||units||Standard Deviation|Mean
1069|NCT02553629|Secondary|Mean Arterial Blood Pressure|"Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit.~The data will be averaged per subject and the mean of the mean values are reported."|2 hours postoperative|||millimeters of mercury||Standard Deviation|Mean
1070|NCT02553629|Secondary|Respiration|"Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged.~The data were averaged per subject and the mean of the mean data are reported."|2 hours postoperative|||breaths per minute||Standard Deviation|Mean
1071|NCT02553629|Secondary|Pain|pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.|postoperative, for up to 2 hours|||units on a scale||Standard Deviation|Mean
1072|NCT02553629|Secondary|Extubation|The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).|intraoperative|||minutes||Inter-Quartile Range|Mean
1073|NCT02553629|Primary|Surgical Rating|"During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated.~The rating scale will be averaged for each subject and the mean values will be reported."|intraoperative|||units on a scale||Standard Deviation|Mean
1074|NCT02553421|Primary|Notification Rate of ivWatch Device|The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is a combination of both false and true notifications – the false notification rate cannot be accurately determined with no gold standard available for comparison. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|||Notifications per day||95% Confidence Interval|Number
1111|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1075|NCT02553421|Primary|Infiltration Sensitivity|The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician’s diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician’s diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|||percentage of infiltrations detected||95% Confidence Interval|Number
1076|NCT02553421|Primary|Time Infiltration Detected by Nurse|The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician’s diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|||hours||95% Confidence Interval|Mean
1077|NCT02552810|Secondary|Percentage of Patients With Bleeding on Probing|Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.|At 5 years.|||percentage of participants|||Number
1078|NCT02552810|Secondary|Percentage of Patients With Plaque Index|Modified Plaque Index (mPI) was evaluated as the amount of plaque at the cervical part of the implant-supported crown, scored by running a probe along the implant-supported crown surface. Measured as Yes or Not.|At 5 years.|||percentage of participants|||Number
1079|NCT02552810|Secondary|Esthetic Parameters Measured as the Changes in Mesial and Distal Papilla Height (PH) and Buccal Peri-implant Mucosa Changes at the Zenith (REC), Expressed in mm.|"A customized millimeter tubular support (stent) was placed temporarily around each dental implant. For each site, mesial and distal soft tissue dimensions (papilla height, PH), and buccal peri-implant mucosa dimension at the zenith (REC) were measured, and reported in millimeters. Two measurements were recorded. The first at definitive crown delivery (baseline), and the second at the 5 years follow-up examination. Changes in PH and REC were reported in millimeters as the difference between values recorded at the 5-year follow-up and the baseline.~The full procedure was published in:~Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clinical Oral Implants Research [Internet]. 2009 Apr;20(4):414–20."|At 5 years.|||mm||Standard Deviation|Mean
1080|NCT02552810|Secondary|Peri-implant Marginal Bone Level Changes (Express in mm).|At the time of loading with the provisional crown (T0), periapical standardized digital or analogical radiographs were taken in order to control the perfect adaptation of the abutment on the implant and control peri-implant bone level. The customized film holder was made using an hard silicone on the bite of film holders (Rinn XCP; Dentsply Rinn, Elgin, IL, USA) and the parallel technique was used. Radiographs were also taken at 12 (T1), 24 (T2), 48 (T4), and 60 months (T5) after the final restoration delivery, to evaluate marginal bone level changes.|At 5 years.|||mm||Standard Deviation|Mean
1081|NCT02552810|Secondary|Any Biological or Technical Complications.|Complications: any biological (pain, swelling, suppuration, etc) and/or mechanical complications (fracture of the framework and/or the veneering material, screw loosening, etc) were considered.|During all the follow-up (5 years)|||participants|||Number
1082|NCT02552810|Primary|Success Rate of the Implants and Prostheses (Participants).|"An implant was considered a failure if it presented any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, and/or any signs of radiolucency, progressive marginal bone loss or infection, and any mechanical complications (e.g. implant fracture) rendering the implant unusable, though still mechanically stable in the bone. This was evaluated on an intraoral radiograph taken with a paralleling technique strictly perpendicular to the implant-bone interface. The implant stability was assessed at initial loading and following 3 years of application, with the prostheses removed.~A prosthesis was considered a failure if it needed to be replaced by an alternative prosthesis."|During all the follow-up (5 years)|||percentage of participants|||Number
1083|NCT02551887|Secondary|Second Dose HPV Vaccine Uptake|The rate of second dose of HPV vaccine uptake, is recorded as the number of patients who receive the second dose of HPV vaccine.|Nine Months|Number in the control condition who were eligible for 2 doses of vaccine.||Participants|||Number
1084|NCT02551887|Primary|First Dose HPV Vaccine Uptake|The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.|Nine Months|Number of patients that received the first dose of HPV vaccine.||Participants|||Number
1085|NCT02550197|Primary|Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.|Day 0 up Day 7 post-vaccination|Solicited injection-site and systemic reactions were analyzed in the Safety Analysis Set.||Percentage of Participants|||Number
1086|NCT02550197|Primary|Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature >38.0˚C for at least 1 day), Malaise, and Shivering (rigors).|Day 0 up Day 3 post-vaccination|Solicited reactions were analyzed in the Safety Analysis Set.||Percentage of Participants|||Number
1087|NCT02550197|Primary|Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titer ratios of influenza antibodies were assessed in the Immunogenicity Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
1112|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1088|NCT02550197|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.|Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.||Percentage of Participants|||Number
1089|NCT02550197|Primary|Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.||Percentage of Participants|||Number
1090|NCT02550197|Primary|Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Immunogenicity Analysis Set.||Percentage of Participants|||Number
1091|NCT02550197|Primary|Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers of influenza antibodies were assessed in the Immunogenicity Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1092|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1093|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1094|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1095|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1096|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1097|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1098|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1099|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1100|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1101|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1102|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1103|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||cm||Standard Error|Mean
1104|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1105|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1106|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1107|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1217|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
1113|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1114|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1115|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1116|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1117|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1118|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1119|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset|||ratio||Standard Error|Mean
1120|NCT02549027|Secondary|Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)||milliseconds||95% Confidence Interval|Mean
1121|NCT02549027|Secondary|Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4||milliseconds||95% Confidence Interval|Mean
1122|NCT02549027|Secondary|WASO Following Single Doses of MK-6096 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)||minutes||95% Confidence Interval|Geometric Mean
1123|NCT02549027|Secondary|Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4||minutes||95% Confidence Interval|Geometric Mean
1124|NCT02549027|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.||participants|||Number
1125|NCT02549027|Primary|Number of Participants With Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.||participants|||Number
1126|NCT02549027|Primary|LPS Following Single Doses of MK-6096 and Placebo|LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)||minutes||95% Confidence Interval|Geometric Mean
1127|NCT02549027|Primary|Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo|LPS is measured during overnight sleep laboratory (polysomnography [PSG]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4||minutes||95% Confidence Interval|Geometric Mean
1128|NCT02549014|Secondary|Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064|t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||hr||Standard Deviation|Geometric Mean
1129|NCT02549014|Secondary|Time to Cmax (Tmax) Following Single Doses of MK-1064|Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||hr||Full Range|Median
1130|NCT02549014|Secondary|Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064|Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||µmol/L||Standard Deviation|Geometric Mean
1131|NCT02549014|Secondary|Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064|AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.||µmol*hr/L||Standard Deviation|Geometric Mean
1132|NCT02549014|Primary|Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064|AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.|Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose|All participants who received ≥1 dose of MK-1064.||µmol*hr/L||Standard Deviation|Geometric Mean
1133|NCT02549014|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.||Participants|||Number
1134|NCT02549014|Primary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.||Participants|||Number
1135|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||ppm||Standard Deviation|Mean
1136|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||ppm||Standard Error|Least Squares Mean
1137|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||ppm||Standard Error|Mean
1156|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1138|NCT02548156|Primary|Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.||parts per million(ppm)||Standard Error|Least Squares Mean
1139|NCT02547454|Secondary|Percentage of Participants With Iron Replacement|Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.|Up to 36 Months|Analysis population included all enrolled participants.||Percentage of participants|||Number
1140|NCT02547454|Secondary|Percentage of Participants With Dose 0|Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.|Up to 36 Months|Analysis population included all enrolled participants.||Percentage of participants|||Number
1141|NCT02547454|Secondary|Number of Dose Adaptations|Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).|Up to 36 Months|Analysis population included all enrolled participants.||Events|||Number
1142|NCT02547454|Secondary|Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.|Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months|Analysis population included all enrolled participants. Here, n signifies participants with available data at specified time-point.||microgram||Full Range|Median
1143|NCT02547454|Secondary|Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline|Baseline|Analysis population included all enrolled participants.||microgram||Standard Deviation|Mean
1144|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L||Up to 36 Months|Analysis population included all enrolled participants.||Months||Full Range|Median
1145|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L||Up to 36 Months|Analysis population included all enrolled participants.||Months||Full Range|Median
1146|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1147|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1148|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1149|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1150|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1151|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1152|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1153|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1154|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1155|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1157|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1158|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1159|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1160|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1161|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1162|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1163|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.||Percentage of participants|||Number
1164|NCT02543918|Primary|Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations|"Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of >=1.0 (International Unit (IU) and a >=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is <=1.0 at baseline OR a >=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is > 1.0 IU at baseline.~Responder to the pneumococcal vaccine is defined as a >=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against >50% of the 23 serotypes."|Week 6|All randomized participants who completed the study.||percentage of participants|||Number
1165|NCT02542280|Primary|Clinical Pregnancy Rate|Ultrasound detection of an intrauterine positive fetal heart pulsations|six weeks|||participants|||Number
1166|NCT02542280|Primary|Chemical Pregnancy Rate|Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.|two weeks after intrauterine insemination|||participants|||Number
1167|NCT02543437|Secondary|Wear Rate(%)|Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.|1 year, 2 years, 3 years and 5 years after surgery||||||
1168|NCT02543437|Primary|Lift Off Distance in Dislocation Maneuver(mm)|Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|participants with available data : 100 hips in 100 participants.||mm|Participants|Standard Deviation|Mean
1169|NCT02543437|Primary|Range of Motion(ROM) (Degree)|Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants.||Degree|Participants|Standard Deviation|Mean
1170|NCT02540850|Secondary|Consistency (the Overall Ratio of True Positive and True Negative)|The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases|1 year|||percentage of true pos&negs in all cases|||Number
1171|NCT02540850|Secondary|Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population)|the ratio of positive cases in all cases|1 year|||percentage of positives in each group|||Number
1172|NCT02540850|Secondary|NPV (the Negative Predictive Value of mSEPT9 Assay in the Population)|the ratio of true negative in all negative cases|1 year|||percentage of true negs in all neg cases|||Number
1173|NCT02540850|Secondary|PPV (the Positive Predictive Value of mSEPT9 Assay in the Population)|the ratio of true positive in all positive cases|1 year|||percentage of true pos in all pos cases|||Number
1174|NCT02540850|Secondary|Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases))|the ratio of negative cases in all non-CRC or NED cases|1 year|||percentage of true negs in non-CRC group|||Number
1175|NCT02540850|Secondary|Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer)|the ratio of positive cases in all CRC cases|1 year|||Percentage of positives in disease group|||Number
1176|NCT02540850|Primary|Ct Value (Ct Values From PCR Reaction)|the number of PCR cycles where the amplification signal starts to be observed|1 year|||Ct||95% Confidence Interval|Mean
1192|NCT02540213|Primary|Change From Baseline in Pain Sensation Using Visual Analogue Scale|Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)’ minus ‘pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application.|Baseline, Months 1-9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure and n = participants evaluable for specified timeframe.||units on a scale||Standard Deviation|Mean
2841|NCT02368314|Secondary|Frequency of Symptomatic Nonlethal PATE||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
1177|NCT02540772|Secondary|Number of Errors in Source Attribution|"After the recall of the material, patients were also asked to remember which modality corresponded to each recall (i.e., seen, heard or imagined), and who had presented the material during the learning session (i.e., the therapist or themselves).~Scores ranged from 0 (if all answers were non-responses) to unlimited number (depending on number of confabulations produced by patients).~The values in the table represent the mean of errors in source attribution for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).||Errors in source attribution||Standard Deviation|Mean
1178|NCT02540772|Primary|Number of Non-responses|"Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).~The values in the table represent the mean of non-responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).||Non-responses||Standard Deviation|Mean
1179|NCT02540772|Primary|Number of Correct Responses|"Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).~The values in the table represent the mean of correct responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of previous outcome measure data, i.e., confabulations).||Correct responses||Standard Deviation|Mean
1180|NCT02540772|Primary|Number of Confabulations|"The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses.~Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the baseline. The values in the table represent the mean of confabulations for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|We used preliminary data from the first 5 patients using the G*Power software to calculate the sample size. From them, to detect differences through a Student t-test considering the significance level is 5%, the sample size was estimated in 7 subjects per group with an alpha of 0.95. We expanded to 10 to ensure greater power.||Confabulations||Standard Deviation|Mean
1181|NCT02540447|Secondary|3 Months Mortality|mortality within first 3 post-operative months|3 Months|||participants|||Number
1182|NCT02540447|Secondary|Post-operative Infectious Complications||30 days|||participants|||Number
1183|NCT02540447|Secondary|Ischemia Reperfusion Injury|incidence of ischemia reperfusion injury in the transplanted graft|7 days|||participants|||Number
1184|NCT02540447|Secondary|Biliary Complications (Participants)|Participants who developed biliary complications in three months period (Participant)|3 months|||participants|||Number
1185|NCT02540447|Primary|Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure|The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping|5 minutes post-reperfusion|||mmHg||Standard Deviation|Mean
1186|NCT02540213|Primary|Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment|Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Participant Satisfaction Set. Here, n = participants evaluable for specified timeframe.||percentage of participants|||Number
1187|NCT02540213|Primary|Mean Monthly Administrations of MIRCERA||9 months|Efficiency Set included all participants who had at least one MIRCERA application, without any major protocol violation and had prescription and application data available for 2 months before start of MIRCERA and first 2 months of study. Here N = participants who were evaluable for this outcome measure.||MIRCERA administrations per month||Standard Deviation|Mean
1188|NCT02540213|Primary|Number of MIRCERA Dose Adaptations||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||dose adaptations||Standard Deviation|Mean
1189|NCT02540213|Primary|Average Monthly Dose of MIRCERA||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||grams||Standard Deviation|Mean
1190|NCT02540213|Primary|Percentage of Participants Who Continued Treatment After End of Study||End of observation period (Month 9)|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1191|NCT02540213|Primary|Percentage of Participants Who Reported Easement of Therapy With MIRCERA||9 months|Participant Satisfaction Set.||percentage of participants|||Number
1216|NCT02538107|Primary|Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment||Up to 50 months|Efficacy analysis set. Participants with non-missing values were included.||months||Standard Deviation|Mean
4458|NCT02259400|Secondary|Bronchopulmonary Dysplasia (BPD)||36 weeks of postconceptional age or time of discharge|2 newborns died in bipap group||participants|||Number
1193|NCT02540213|Secondary|Change From Baseline in Hemoglobin (Hb) Concentration||Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Secondary endpoint set included all participants who had at least one MIRCERA application, without any major protocol violation and had at least 6 months documentation and minimum 2 of the 3 visits non-missing Hb and dosing data from Month 7 to 9 visits. N=participants evaluable for this outcome and n=participants evaluable for specified timeframe.||g/dL||Standard Deviation|Mean
1194|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1195|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 8|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1196|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 7|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1197|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 6|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1198|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 5|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1199|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 4|Participant Satisfaction Set. Here N = participants who were available for this outcome measure.||percentage of participants|||Number
1200|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 3|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1201|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 2|Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure.||percentage of participants|||Number
1202|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 1|Participant Satisfaction Set.||percentage of participants|||Number
1203|NCT02540213|Primary|Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.|Baseline|Participant Satisfaction Set included all participants who had at least one MIRCERA application, without any major protocol violation and had satisfaction rating documented for previous ESA and MIRCERA.||percentage of participants|||Number
1204|NCT02539992|Secondary|Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
1205|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
2842|NCT02368314|Secondary|Frequency of Distal DVT|Frequency of distal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)||||||
1206|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).|"The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by no problem in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
1207|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.|The FJS consists of 12 questions and focuses on the patients’ awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
1208|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.|KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
1209|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test|"Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.~One source suggests that scores of ten seconds or less indicate normal mobility, 11 – 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls."|1 year|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.||seconds||Standard Deviation|Mean
1210|NCT02539992|Primary|Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.|To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.|6 months|Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.||Degrees||Standard Deviation|Mean
1211|NCT02539108|Secondary|Geometric Mean Titer Ratios of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
1212|NCT02539108|Secondary|Number of Participants Who Achieved Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-final vaccination titer.|28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.||Participants|||Number
1213|NCT02539108|Secondary|Number of Participants Who Achieved Seroprotection to Influenza Virus Antigens Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as a pre-vaccination or post-vaccination influenza antibody titer of ≥ 1:40 (1/dilutions).|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.||Participants|||Number
1214|NCT02539108|Secondary|Geometric Mean Titers of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1215|NCT02539108|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine.|"Solicited injection-site reactions for 6 to < 36 months: Tenderness, Erythema, and Swelling. For 3 to < 9 years: Pain, Erythema, and Swelling. Solicited systemic reactions for 6 to < 36 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. For 3 to < 9 years: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 for 6 to < 36 months: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Vomiting, 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.~Grade 3 for 3 to < 9 years: Pain, Incapacitating; Erythema and Swelling, ≥ 50 mm; Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, prevents daily activity."|Day 0 up to Day 7 post any vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
2843|NCT02368314|Secondary|Frequency of Proximal DVT|Frequency of proximal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)||||||
1218|NCT02538107|Secondary|Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)|GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
1219|NCT02538107|Secondary|Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study|Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
1220|NCT02538107|Secondary|Hemoglobin Level Based on the Etiology of Chronic Kidney Disease|Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
1221|NCT02538107|Secondary|Hemoglobin Level Based on the Presence of Inflammatory Diseases|Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
1222|NCT02538107|Secondary|Hemoglobin Level Based on the Type of Kidney Transplantation Performed|Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.||g/dL||Standard Deviation|Mean
1223|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
1224|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
1225|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.||percentage of participants|||Number
1226|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set.||percentage of participants|||Number
1227|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits [Visits 7-9]).||percentage of participants|||Number
1228|NCT02537730|Secondary|Stinging and Burning Sensation|Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.|Baseline|||units on a scale||Standard Deviation|Mean
1229|NCT02537730|Secondary|Dryness|Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week|||units on a scale||Standard Deviation|Mean
1230|NCT02537730|Secondary|Comfort|Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week|||units on a scale||Standard Deviation|Mean
1231|NCT02537730|Primary|Ocular Health - Corneal Staining|Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.|1 week|||Eyes|Participants||Number
1241|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up||||||
1232|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Corneal Diameter|Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.||Pearson Correlation|||Number
1233|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Keratometry|CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.||Pearson Correlation|||Number
1234|NCT02536664|Secondary|Percentage of Participants With Initiation of New Therapy|Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants|||Number
1235|NCT02536664|Secondary|Percentage of Participants With Best Overall Response|The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants||95% Confidence Interval|Number
1236|NCT02536664|Secondary|Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy|CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants|||Number
1237|NCT02536664|Secondary|Median Overall Survival (OS) Time|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||months||95% Confidence Interval|Median
1238|NCT02536664|Secondary|Percentage of Participants Who Were Alive|Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants||95% Confidence Interval|Number
1239|NCT02536664|Secondary|Median Progression Free Survival (PFS) Time|PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||months||95% Confidence Interval|Median
1240|NCT02536664|Primary|Percentage of Participants Who Were Alive and Free From Progressive Disease|Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.||percentage of participants||95% Confidence Interval|Number
1349|NCT02519595|Secondary|Adverse Events|Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them|Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,|||participants|||Number
1242|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire|The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up||||||
1243|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up||||||
1244|NCT02535741|Secondary|Investigation of Patient Outcome With Radiographic Analysis|Plain radiographs will be obtained for assessment of fixation of the device.|Pre-operative, 3 months, 1, 2 and 5 years follow-up||||||
1245|NCT02535741|Primary|Comparison of the Active Range of Motion (ROM) Values Between Triathlon CR and Active ROM Values of Scorpio CR From the Literature|Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.|2 years follow-up|134 cases at 2 years follow-up of the Triathlon CR study have been compared to 40 cases from a historical Scorpio CR study.||degree||Standard Deviation|Mean
1246|NCT02534324|Secondary|Systolic Blood Pressure at Follow-up|Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.|3 to 7 days|||mmHg||Standard Deviation|Mean
1247|NCT02534324|Secondary|Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department|Participants who had major hypertensive-related events defined by those who had one or more of the followings: acute chest pain, heart failure, acute coronary syndromes, acute aortic syndromes, retinal/vitreous hemorrhage, hypertensive retinopathy, seizure, acute cerebrovascular diseases, hypertensive encephalopathy, which occurred within 7 days after discharge from emergency department.|7 days|||participants|||Number
1248|NCT02534324|Primary|Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department|Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.|7 days|||participants|||Number
1249|NCT02533401|Primary|Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)|Treatment response was monitored throughout the study and assessed using standardized criteria. CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values. Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR. The percentage of participants with each level of best overall response was calculated.|Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)|All Participants Enrolled.||percentage of participants|||Number
1250|NCT02533401|Primary|Overall Survival (OS)|Participants were followed for survival throughout the study. OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis|Up to 5 years (from Baseline until death)|All Participants Enrolled.||months||95% Confidence Interval|Mean
1251|NCT02533401|Primary|Percentage of Participants Who Died|Participants were followed for survival throughout the study. The percentage of participants who died of any cause during the study was calculated.|Up to 5 years (from Baseline until death)|All Participants Enrolled.||percentage of participants|||Number
1252|NCT02533401|Primary|Progression-Free Survival (PFS)|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.||months||95% Confidence Interval|Mean
1253|NCT02533401|Primary|Percentage of Participants With Death or Disease Progression|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. The percentage of participants with death or documented disease progression at any time during the study was calculated.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.||percentage of participants|||Number
1254|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.||units on a scale|images|Standard Error|Mean
4459|NCT02259400|Secondary|Death||2 month|||participants|||Number
1255|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.||units on a scale|images|Standard Error|Mean
1256|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 month|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for DT Investigational - Scout & DT Volume.||units on a scale|images|Standard Error|Mean
1257|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 2 - PA and LAT Chest arm above.||units on a scale|images|Standard Error|Mean
1258|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 1 - PA Chest arm above.||units on a scale|images|Standard Error|Mean
1259|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|||units on a scale|images|Standard Error|Mean
1260|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|||units on a scale|images|Standard Error|Mean
1261|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|||units on a scale|images|Standard Error|Mean
1288|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|2 years Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
1262|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|224 image ratings from 7 radiologist readers (32 images rated x 7 readers) for Predicate & Invest. DE - Human Subjects arm above.||units on a scale|images|Standard Error|Mean
1263|NCT02531308|Primary|Progression Free Survival|rate of progression in patients 2 years after diagonosis|2 year|Study terminated prematurely.|||||
1264|NCT02530671|Secondary|Comparison of BSI Between Periods||0-3, 9-12 months|||percentage of the original bristle field||Standard Deviation|Mean
1265|NCT02530671|Primary|Bristle Splay Index (BSI) After a Specific Time-of-use|A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).|3, 6, 9 and 12 months|||percentage of the original bristle field||Standard Deviation|Mean
1266|NCT02530671|Secondary|Pocket Probing Depths at 12months||12 months|||mm||Standard Deviation|Mean
1267|NCT02530671|Secondary|Percentage of Recession Sites Demonstrating a Change of ≥1mm||12 months|||percentage of sites|||Number
1268|NCT02530671|Secondary|Recession at All Buccal Sites||12 months|||mm||Standard Deviation|Mean
1269|NCT02530671|Primary|Gingival Recession at Sites With Preexisting Recessions ≥2mm||12 months|||mm||Standard Deviation|Mean
1270|NCT02530450|Secondary|% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia||3 months and 6 months||||||
1271|NCT02530450|Primary|The Primary Outcome Measure Was Change in HgbA1c||0 months, 3 months and 6 months|||HbgA1c %||Inter-Quartile Range|Median
1272|NCT02528331|Secondary|Percentage of Adverse Events||6 weeks|||percentage of adverse events|||Number
1273|NCT02528331|Secondary|Partial Response Rate, as Measured by Y-BOCS|Partial response is defined as a reduction of greater than 25%.|6 weeks|||percentage of participants|||Number
1274|NCT02528331|Secondary|Complete Response, as Measured by Y-BOCS|Complete response is defined as a reduction of Y-BOCS score greater than 35%.|6 weeks|||percentage of participants|||Number
1275|NCT02528331|Primary|Remission Rate, as Measured by Y-BOCS|Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.|6 weeks|||percentage of participants|||Number
1276|NCT02528097|Other Pre-specified|Administration of Albumin|The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)|Throughout Study (72 hours)||||||
1277|NCT02528097|Secondary|All Cause Mortality||At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.|||||
1278|NCT02528097|Primary|Renal Failure|Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours|At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.|||||
1279|NCT02527161|Secondary|Pain|Measured by Visual analogue scale (VAS)|5 years Post-Operatively||||||
1280|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|2 years Post-Operatively|Participants with available data. Participants = knees. 87 knees had VAS pain during mobilization measurements and 86 knees had VAS pain at rest measurements.||centimeters||Standard Deviation|Mean
1281|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|12 months Post-Operatively|Participants with available data. Participants=knees.||centimeters||Standard Deviation|Mean
1282|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|6 months Post-Operatively|Participants with available data. Participants=knees.||centimeters||Standard Deviation|Mean
1283|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)||5 years Post-Operatively||||||
1284|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|2 years Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
1285|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|12 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
1286|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|6 months Post-Operatively|Participants with available data. Participants = knees.||units on a scale||Standard Deviation|Mean
1287|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)||5 years Post-Operatively||||||
1289|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|12 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
1290|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|6 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
1291|NCT02527161|Secondary|Revision Rate||5 years Post-Operatively||||||
1292|NCT02527161|Secondary|Mechanical Alignment|AnteroPosterior Long Leg X-rays: Alignment measured to mechanical axis at zero degrees.The mechanical axis is defined by lines joining the centre of the femoral head, centre of the knee joint and the centre of the ankle. A negative value = knee varus and a positive value = knee valgus.|12 months Post-Operatively|Participants with available data. Participants=knees.||degrees||Full Range|Mean
1293|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|5 years Post-Operatively||||||
1294|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|2 years Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
1295|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|12 months Post-Operatively|Participants with available data. Participants=knees||units on a scale||Standard Deviation|Mean
1296|NCT02527161|Primary|Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|6 months Post-Operatively|Participants with available data. Participants=knees.||units on a scale||Standard Deviation|Mean
1297|NCT02527161|Primary|Implant Location/Assessment of Alignment|Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.|3 months Post-Operatively|Participants with available data. Participants=knees.||degrees||Standard Deviation|Mean
1298|NCT02527148|Secondary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated at 2 years and 5 years post-operatively. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|2 and 5 years||||||
1299|NCT02527148|Secondary|Perth CT Protocol|The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (–) value = varus.|3 months|Participants=knees||degrees||Standard Deviation|Mean
1300|NCT02527148|Secondary|The International Knee Society Score (IKSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively||||||
1301|NCT02527148|Secondary|The Forgotten Joint Score (FJS-12)|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|6-week, 6-month,12 month visits, 2 years and 5 years||||||
1302|NCT02527148|Secondary|Health-related Quality of Life (EQ-5D-3L)|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1= the value for full health.~The EQ VAS records the participant’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 =‘Best imaginable health state’ to 0= ‘Worst imaginable health state’."|Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years||||||
1303|NCT02527148|Secondary|The Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively||||||
1304|NCT02527148|Secondary|Knee Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively||||||
1305|NCT02527148|Secondary|Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L|A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores.|12 months|"Shapematch preoperative N=49, 12 month N=48.~Navigation preoperative N=50, 12 month N-49."||QALY life year||Standard Deviation|Mean
1306|NCT02527148|Secondary|Cost Effectiveness: Length of Stay in Hospital|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported..|14 days|||days||Standard Deviation|Mean
1307|NCT02527148|Secondary|Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|Cost effectiveness data is not available.|||||
1308|NCT02527148|Secondary|Cost Effectiveness: Wound Length|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|||millimeters||Standard Deviation|Mean
1309|NCT02527148|Secondary|Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)|Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|||minutes||Standard Deviation|Mean
1310|NCT02527148|Primary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months and 12 months. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|Preoperatively, 6-week, 6-months,and 12 months postoperatively|"Shapematch: 49 had preoperative and 6 month scores,48 had 6 week and 12 month scores.~Navigation: 50 had preoperative, and 6 month scores, 47 had 6 week, and 37 had 12 month scores~Participants=knees"||units on a scale||Standard Deviation|Mean
1311|NCT02526550|Secondary|Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™|Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.|Up to 28 days post booster vaccination|||percentage of participants|||Number
1312|NCT02526550|Secondary|Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (Baseline) and Day 28 (post-vaccination)|||percentage of participants|||Number
1313|NCT02526550|Primary|Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).|Day 0 (Baseline) and Day 28 (post-vaccination)|Per-protocol analysis||titers||95% Confidence Interval|Geometric Mean
1314|NCT02525536|Primary|Accumulation Ratio (AR) for AMG 386|Accumulation ratio (AR) was calculated by dividing the individual AUC (0-tau) value at Week 4 by the corresponding individual AUC (0-tau) value at Week 1.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose, Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||ratio||Standard Deviation|Mean
1348|NCT02519595|Secondary|Sedation Satisfaction|Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3|At the end of the procedure. Approximately 1 hour|consultant satisfaction missing in 6 participants||participants|||Number
1350|NCT02519595|Secondary|Additional Dose|Number of participants to whom additional doses of ketamine administered apart from the study dose|Patients will be assessed during procedure . Approximately 1 hours|||participants|||Number
1315|NCT02525536|Primary|Systemic Clearance at Steady State (CLss) for AMG 386|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Systemic clearance at steady state (CLss) was calculated as the ratio of dose administered to AUC (0 – tau), where AUC (0 – tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen). CLss was normalized to participant’s body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96 and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||milliliter/hour/kilogram(mL/hr/kg)||Standard Deviation|Mean
1316|NCT02525536|Primary|Terminal Phase Elimination Half-life (T1/2) for AMG 386|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||hr||Standard Deviation|Mean
1317|NCT02525536|Primary|Vss: Volume of Distribution at Steady State for AMG 386|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state, estimated as: Vss = MRTinf *CLss, where MRTinf is mean residence time of drug extrapolated to infinity and CLss is the systemic clearance at the steady state. Vss was normalized to participant’s body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
1318|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 4 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 4: 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||mcg/mL||Standard Deviation|Mean
1319|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 1 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||mcg/mL||Standard Deviation|Mean
1320|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 4 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||mcg*hr/mL||Standard Deviation|Mean
1321|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 1 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
1322|NCT02525536|Secondary|Number of Participant With Anti-AMG 386 Antibody|The immunogenicity of AMG 386 was evaluated with an immunoassay that detects anti-AMG 386 binding antibodies. Antibody formation reported at any of the time points was summarized.|Week 1: predose,1,2,6,24,48 and 98 hours after infusion end, Week 3: predose, Week 4: predose, 1,2,6,24,48,96,168 and 264 hours after infusion end, thereafter predose every 4 weeks starting from Week 8 up to 8 weeks after last dose (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
1323|NCT02525536|Secondary|Percent Change From Baseline to Post-baseline in the Sum of the Longest Diameters of Tumor|The percent change from baseline to post-baseline is the largest percent reduction from baseline among all post-dose measures of the sum of the longest diameter of the tumor burden.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0 and valid post-baseline tumor lesion assessment available. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.||percent change||Standard Deviation|Mean
1324|NCT02525536|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of first administration of study treatment to the date of first documentation of PD or death caused by progression. For participants who did not have a documented PD or died owing to causes other than progression, TTP was censored at the time of last response assessment. PD is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG386.||Days||Full Range|Median
1325|NCT02525536|Secondary|Percentage of Participants With Objective Response|Objective response rate defined as the rate of participants with CR or PR based on RECIST 1.0 criteria. CR: disappearance of all target lesions, non-target lesions and normalization of tumor marker level. PR: at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.||Percentage of participants||95% Confidence Interval|Number
2844|NCT02368314|Secondary|Frequency of DTV|Frequency of DTV (proximal and/or distal; symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)||||||
1326|NCT02525536|Secondary|Number of Participants With Best Overall Response|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above the normal limits. PD: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the full analysis set (FAS) with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.||participants|||Number
1327|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 4 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||hr||Full Range|Median
1328|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 1 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||hour (hr)||Full Range|Median
1329|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 4 Dose|Cmax is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.||mcg/mL||Standard Deviation|Mean
1330|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 1 Dose|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1331|NCT02525536|Primary|Number of Participants With Abnormal Laboratory Values|The number of participants with any abnormal standard safety laboratory values collected throughout study. Parameters assessed were hematology, chemistry, coagulation and urinalysis. Abnormal laboratory values observed at any time point was summarized and reported.|Week 1: predose, 24, 48 and 96 hours after infusion end, Week 2 and 3: predose, Week 4: predose and 1 hour after infusion end, thereafter every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
1332|NCT02525536|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, diastolic and systolic blood pressure, and pulse (beats per minutes). clinically significant change in vital signs observed at any time point was summarized and reported.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after infusion end, Week 2, 3, 4: predose and 1 hour after infusion end, thereafter predose of every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
1333|NCT02525536|Primary|Number of Participants With Significant Change From Baseline in Electrocardiogram (ECG)|Change relative to baseline in electrocardiogram measured throughout study. Significant change in ECG observed at any time point was summarized and reported.|Week 1: predose, 1, 6 hours after end of infusion, Week 4: predose, 1 hour after end of infusion, Week 8, 16: predose, thereafter predose of every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
1334|NCT02525536|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (AEs) and Serious Adverse Event (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.||participants|||Number
1335|NCT02525536|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is defined as any treatment-related, grade 4 or higher hematologic or grade 3 or higher non-hematologic toxicity (according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0; hematologic toxicity means any toxicities which are categorized in blood/bone marrow category of CTCAE), except for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and infusion reaction, occurred during the first 28 days after the initial administration (before examination on Study Day 29). DLT also includes AST or ALT: >10*upper limit of normal (ULN) international units per liter (IU/L).|Day 1 up to Day 28|DLT analysis set: all participants who experience at least 1 DLT in the first 28 days of treatment, or who received all planned AMG 386 dose and are followed until the day before the treatment on Study Day 29.||participants|||Number
1336|NCT02522624|Secondary|Intended Choice Metal Level|Participants indicated the plan they would choose that day. We categorized plans by governmental classifications of metal level (catastrophic, bronze, silver, gold).|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|Intended plan choice metal level data were not available for 2 participants in SMHP (Show Me My Health Plans decision aid) condition (n=162) and for 11 participants in healthcare.gov (Control) condition (n=152)||participants|||Number
1337|NCT02522624|Secondary|Improvements in HILM 2 (Health Insurance Literacy Measure)|Assessed confidence understanding terms.Improvement in HILM was defined as moving from “not confident” pre-intervention to “a little confident” or “very confident” post-intervention, or from “a little confident” pre-intervention to “very confident” post-intervention.|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)||participants|||Number
1338|NCT02522624|Secondary|Improvements in HILM 1 (Health Insurance Literacy Measure)|Assessed confidence estimating costs of care.Improvement in HILM was defined as moving from “not confident” pre-intervention to “a little confident” or “very confident” post-intervention, or from “a little confident” pre-intervention to “very confident” post-intervention.|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)||participants|||Number
1339|NCT02522624|Primary|Confidence in Choice|The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) decisional conflict scale assessed confidence in plan choice. Each item could be answered dichotomously (1=yes; 0=no). Responses were summed and a group average was obtained. Higher SURE values indicate more confidence in choice.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|||units on a scale||Standard Deviation|Mean
1340|NCT02522624|Primary|Decision Self-efficacy|The decision self-efficacy (DSE) scale measured participants' perceived ability to understand insurance info and resist unwanted decision pressure. The 6 items on the DSE scale were each rated on a 3-point scale (0=Not confident; 2=A little confident; 4=Very confident). The sum of the DSE items was divided by 6 and multiplied by 25 to obtain a score on a 0-100 scale. Higher values indicate more confidence in one’s decision-making ability.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|||units on a scale||Standard Deviation|Mean
1341|NCT02522624|Primary|Knowledge Score (% Correct)|8 questions developed in researchers' past work. Assessed health insurance knowledge.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|||percentage of 8 items correctly answered||Standard Deviation|Mean
1342|NCT02519855|Primary|Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody|Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
1343|NCT02519855|Primary|Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody|Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
1344|NCT02519855|Primary|Geometric Mean Titers of H3N2-specific Influenza Virus Antibody|Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
1345|NCT02519855|Primary|Geometric Mean Titers of H1N1-specific Influenza Virus Antibody|Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Titer||95% Confidence Interval|Geometric Mean
1346|NCT02519855|Primary|Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||Ratio of titers (Week 4 / Baseline)||95% Confidence Interval|Geometric Mean
1347|NCT02519855|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1351|NCT02519595|Secondary|Sedation Duration|Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution.|Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours|||Minutes||Inter-Quartile Range|Median
1352|NCT02519595|Primary|Pain|"Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, No hurt to a crying face at 10 Hurts worst. The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4)."|Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes|||units on a scale||Inter-Quartile Range|Median
1353|NCT02519595|Primary|Sedation Efficacy|Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.|Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours|||units on a scale||Inter-Quartile Range|Median
1354|NCT02519387|Secondary|Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events||3 months|This is the intent-to-treat population.||participants|||Number
1355|NCT02519387|Secondary|Physicians’ and Patients’ Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|3 months|||units on a scale||Standard Deviation|Mean
1356|NCT02519387|Secondary|Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage|Patients will record any other pain medication used in a patient home diary|3 months|||participants|||Number
1357|NCT02519387|Secondary|Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)|"Subjects will evaluate the degree of their sleep disturbance due to pain and improvement in quality of sleep using the GSQA questionnaire comprising of 8 questions, at baseline (Visit 1) and Visit 6 (3 months from baseline visit).~The scores at baseline and Visit 6 are calculated for the following 8 items with scores of:~Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always~Need for pain medication to sleep -- as above~Need for sleep medication to sleep -- as above~Awakened by pain at night -- as above~Awakened by pain in the morning -- as above~Pain affecting partner's sleep -- as above~Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor~Number of hours of sleep per night in last 7 days"|Baseline, 3 months|||units on a scale||Standard Deviation|Mean
1358|NCT02519387|Primary|Change in Box Scale-11 (BS-11) Pain Score|"The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported.~BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Baseline,3 months|These patients were eligible and included in the intent-to-treat efficacy population.||units on a scale||Standard Deviation|Mean
1359|NCT02516163|Primary|Repeatability of Cutting Guide Position|Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|||intraclass correlation coefficient (ICC)|Participants|95% Confidence Interval|Number
1360|NCT02516098|Secondary|Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product (AUCReftmax)|Area under the concentration-time curve of hyoscine butylbromide, for the test product (Buscapina®), to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1361|NCT02516098|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).|The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1362|NCT02516098|Primary|AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)|Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population||hour (h)*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1376|NCT02512679|Primary|Number of Participants With Disease Recurrence at 1 Year Post-transplant|assess rate of disease recurrence (“late relapse”) due to autologous recovery of recipient hematopoiesis at one year post-HSCT.|1 year|All subjects who received dose level 1 of Cyclophosphamide did not experience re-occurrence of disease.||participants|||Number
1363|NCT02516098|Primary|Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)|The maximum measured concentration of hyoscine butylbromide in plasma.|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|All subjects who had evaluable pharmacokinetic (PK) data for at least one of the treatment periods were included in the PK population.||picogram (pg)/millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1364|NCT02515994|Secondary|Average Wear Time|Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.|3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||Hours per day||Standard Deviation|Mean
1365|NCT02515994|Secondary|Symptoms|"Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item Experienced Eye Symptoms or Problems? were reported."|Up to 3 month Follow-up|All subjects that were dispensed a study lens.||Eyes|Participants||Number
1366|NCT02515994|Primary|Visual Acuity|Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.|Up to 3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.||LogMAR|Participants|Standard Deviation|Mean
1367|NCT02515994|Primary|Slit Lamp Findings|Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.|Up to 3 Month Follow-up|All subjects that were dispensed a study lens.||Eyes|Participants||Number
1368|NCT02515279|Primary|Percentage of Participants With Sustained Virologic Response 24 (SVR24)|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.|18 months|All participant who were enrolled in the study. N=number of participants evaluable for this measure.||percentage of participants|||Number
1369|NCT02515279|Primary|Percentage of Participants With End of Treatment Response|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.|12 months|All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.||percentage of participants|||Number
1370|NCT02515279|Primary|Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|Up to 6 years|All participants who were enrolled in the study.||percentage of participants|||Number
1371|NCT02512783|Secondary|Parental Assessment of Child's Pain on a Visual Analog Scale||Immediately following propofol injection|This data was not collected.|||||
1372|NCT02512783|Primary|Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score|The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.|1 minute before propofol induction compared to 1 minute following propofol induction|||units on a scale||Standard Deviation|Mean
1373|NCT02512679|Secondary|Number of Participants Who Were Disease Progression-Free and Death-Free at 1 Year Post-transplant|Evaluation for engraftment, correction of the disease, transplant related complications and event-free survival and overall survival of the subjects post-transplant was undertaken by standard measures and evaluation of disease with disease-specific testing.|1 yr|Subjects receiving dose level 1 of Cyclophosphamide event free survival post transplant at 100 days was 95% and 90% 1 year.||participants|||Number
1374|NCT02512679|Secondary|Number of Participants Who Developed Graft-Versus-Host-Disease (GVHD) as Determined by the Glucksberg Scale|Clinical evaluation on a daily basis during hospitalization and at each post transplant clinical visit, up to one year, to determine incidence of acute and chronic graft-versus-host disease using Glucksberg grading scale. Acute graft-versus-host disease (aGVHD) develops within the first three months after transplantation and appears as a skin rash, often accompanied by hyperbilirubenemia, abnormal liver enzymes and gastrointestinal symptoms, as diarrhea, nausea and vomiting. Level of aGVHD is graded from 1-4. Chronic GVHD, typically a late complication of Blood and Marrow Transplantation (BMT) characterized by skin changes, sometimes sclerotic changes, with joint contractures, liver function abnormality, gastrointestinal symptoms and sometime other organ involvement such as eyes, lungs, and obliterative bronchiolitis (OB). Chronic GVHD is graded as absent, limited, or extensive.|1 yr|Subjects who received dose level 1 of Cyclophosphamide were revaluated for graft-versus-host disease (GVHD) post transplantation.||participants|||Number
1375|NCT02512679|Primary|Number of Participants Who Developed Severe Mucositis, Veno-occlusive Disease (VOD), Toxicity of the Kidney, Liver, or Gastrointestinal (GI) Tract up to 1 Year Post-transplant|Assessment of conditioning regimen related toxicity was evaluated and documented with daily assessment during hospitalization and post-transplant follow-up up to one year. None of the subjects developed VOD necessitating any therapeutic intervention, severe mucositis, or toxicity of the Kidney, Liver or Gastrointestinal.|1 year|Subjects who received dose level 1 of Cyclophosphamide did not experience veno-occlusive disease, organ failure or severe mucositis.||participants|||Number
6050|NCT02179398|Secondary|Presence of Serious Bacterial Infection||at 72 hours from PED presentation|||participants|||Number
1377|NCT02512679|Primary|Number of Participants With Neutrophil Engraftment (=/>500 Cells/uL) and Platelet Engraftment (>20K Cell/uL) at 30 Days|Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20,000 per cubic milimeter (20K) - evaluation by Chimerism Study (STR or FISH) at day +30|30 days|Subject enrolled and received Dose Level 1 of Cyclophosphamide and engrafted with Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20k - evaluation by Chimerism Study (STR or FISH) at day +30.||participants|||Number
1378|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 30 Days||30 days after the start of the procedure|||participants|||Number
1379|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 14 Days||14 days after the start of the procedure|||Participants|||Number
1380|NCT02512224|Secondary|Re-admission 30 Days||re-admission within 30 days of discharge.|||Participants|||Number
1381|NCT02512224|Secondary|Post-procedural Sepsis||the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.|||Participants|||Number
1382|NCT02512224|Secondary|Post-procedural Pneumonia||the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.|||Participants|||Number
1383|NCT02512224|Primary|Mortality Calculated From Outcome Section From DPC Database at 90 Days||90 days after the start of the procedure|||Participants|||Number
1384|NCT02510820|Primary|Overall Score|Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.|1 week, 2 weeks, 4 weeks|Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue).||units on a scale||Standard Deviation|Mean
1385|NCT02510820|Primary|Ease of Use of Solution|Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy|1 week, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
1386|NCT02510820|Primary|Ease of Lens Removal|Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1387|NCT02510820|Primary|Ease of Lens Insertion|Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1388|NCT02510820|Primary|Ocular Redness|Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1389|NCT02510820|Primary|Burning/Stinging|Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.|1 week, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
1390|NCT02510820|Primary|Dryness|Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.|1 week, 2 weeks, 4 weeks|||units on a scale||Standard Deviation|Mean
1391|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1392|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|2 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1393|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|1 week|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1394|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1395|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|2 weeks|The difference in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1396|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|1 week|||units on a scale||Standard Deviation|Mean
1397|NCT02510820|Primary|Papillary Conjunctivitis|Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1398|NCT02510820|Primary|Corneal Staining|Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1399|NCT02510820|Primary|Limbal Hyperaemia|Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1400|NCT02510820|Primary|Conjunctival Hyperaemia|Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.||units on a scale||Standard Deviation|Mean
1401|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24.|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Week 12 and 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.||Percentage||95% Confidence Interval|Number
1402|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire.||Percentage||95% Confidence Interval|Number
1403|NCT02507752|Secondary|Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular domain of SF-36.||scores on a scale||Standard Error|Mean
1404|NCT02507752|Secondary|Change in SF-36 Physical and Mental Component Scores From Screening to Week 12|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular component of SF-36.||scores on a scale||Standard Error|Mean
1405|NCT02507752|Secondary|Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24|Visual Analogue Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from Screening=scores at observation minus score at Screening. An increase in score from Screening represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. The change in pain scale was analyzed for the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
1443|NCT02504320|Primary|Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat|AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
1406|NCT02507752|Secondary|Change in HAQ Score From Screening to Weeks 12 and 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The number of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
1407|NCT02507752|Secondary|Mean Change From Baseline in Patient Global Assessment (100 mm VAS)|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = scores at observation minus score at Baseline. An increase in score from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
1408|NCT02507752|Secondary|Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Units on a scale||Standard Error|Mean
1409|NCT02507752|Secondary|Mean Change From Baseline in Tender Joint Count (TJC)|A tender joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It is associated more with the level of pain.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Number of tender joints||Standard Error|Mean
1410|NCT02507752|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC)|A swollen joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It reflects the amount of inflamed synovial tissue.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||Number of swollen joints||Standard Error|Mean
1411|NCT02507752|Secondary|Mean Change From Baseline in C-reactive Protein (CRP).|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||mg/L||Standard Error|Mean
1412|NCT02507752|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate is an acute phase reactant and a measure of inflammation.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.||mm/hr||Standard Error|Mean
1413|NCT02507752|Secondary|Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.|An infusion reaction is defined as an adverse event that occurs during infusion or within 24 hours after infusion of Rituximab. All infectious events, whether considered related or not to Rituximab, were collected for the safety analysis of the study. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Up to 24 Weeks|The ITT population included all screened participants who answered at least one SF-36 questionnaire.||participants|||Number
1414|NCT02507752|Primary|Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline and Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.||scores on a scale||Standard Error|Mean
1441|NCT02504775|Primary|Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]|AUC(0-t) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 hours (h) after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||hours*microgram/millilitre (h*μg/mL)||Standard Deviation|Mean
1537|NCT02495831|Secondary|Lamda z||24 hours|||1/hours||Standard Deviation|Mean
1538|NCT02495831|Secondary|Tmax and T1/2||24 hours|||hours||Standard Deviation|Least Squares Mean
1415|NCT02507752|Primary|Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire.||Percentage||95% Confidence Interval|Number
1416|NCT02507375|Secondary|Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Steady-state volume of distribution of a drug is an estimate of drug distribution independent of elimination processes. It is most useful for predicting the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state (pseudo-equilibrium). It is a calculated measure.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset||Liters||Standard Deviation|Mean
1417|NCT02507375|Secondary|Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|A fundamental concept in pharmacokinetics is drug clearance (CL), that is, elimination of drugs from the body. The clearance is simply the ratio of the dose to the area under the curve (AUC), so that the higher the AUC for a given dose, the lower the clearance. If a drug is administered by continuous infusion and a steady state is achieved, the clearance can be estimated from a single measurement of the plasma drug concentration.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK subset||L/day||Standard Deviation|Mean
1418|NCT02507375|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC)|Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person’s bloodstream from time 0 (pre-dose) to a given time point (t) for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug’s blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL), which equates to mg.day/L. Bioavailability Extrapolated to Infinity [AUC (0-inf)] is a calculated measure of how much of the drug will ever reach the person’s bloodstream for the body to use. AUC (0-inf) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-inf).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset with appropriate data available||mg*day/L||Standard Deviation|Mean
1419|NCT02507375|Secondary|Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset with adequate data for this analysis||days||Standard Deviation|Mean
1420|NCT02507375|Secondary|Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|The time at which maximum concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, is reached (Tmax).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset||days||Standard Deviation|Mean
1421|NCT02507375|Secondary|Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, typically measured in nanograms/milliliter (ng/mL), reported as mg/L.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset, defined as all participants from either cohort with adequate data for performing PK analysis||mg/L||Standard Deviation|Mean
1422|NCT02507375|Secondary|Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6|Complete and partial responses were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A complete response was defined as the disappearance of all target and non-target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.|From baseline to the end of the study (up to 42 weeks)|||Percentage of participants|||Number
1423|NCT02507375|Secondary|Percentage of Participants Classified as Responders|"Responders are participants who achieved either a complete response or a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 18 weeks|Full analysis set||percentage of participants|||Number
1442|NCT02504320|Primary|Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat|AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
3072|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 6 hours|||mean number of doses used||Standard Deviation|Mean
1424|NCT02507375|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|A DLT was defined as: Any non-hematological toxicity ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events, version 3.0, except for fever, chills, and flu-like symptoms, which occurred despite adequate participant management. The following Grade 1-3 toxicities were exempt: Grade 1-3 skin and/or epithelial toxicities consistent with erlotinib single agent therapy, unless they did not respond to treatment or dose reduction or interruption (Grade 4 skin and/or epithelial toxicities were considered to be a DLT); Grade 4 neutropenia occurring for > 7 days; febrile neutropenia which occurred despite adequate participant management; Grade 4 thrombocytopenia or any thrombocytopenia requiring platelet transfusion; and any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From baseline to end of the study (up to 42 weeks)|||Percentage of participants|||Number
1425|NCT02506881|Secondary|Cl|Serum clearance of of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||hours*kg||Inter-Quartile Range|Median
1426|NCT02506881|Secondary|Tmax|Time to achieve maximum serum concentration of darbepoetin alfa after single sc of iv administration|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||hours||Inter-Quartile Range|Median
1427|NCT02506881|Secondary|T1/2|Serum half-life of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||hours||Inter-Quartile Range|Median
1428|NCT02506881|Primary|AC-Emax|"Maximum elevation of absolute reticulocyte count from the baseline from the Moment of Drug Administration Until 504 hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for analysis of pharmacodynamics included patients who received at least one study drug injection.||reticulocytes * 10^9/l||Inter-Quartile Range|Median
1429|NCT02506881|Primary|AUEC|"Area Under Effect Curve (AUEC) of reticulocytes count from the Moment of Drug Administration Until 504 hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for pharmacokinetics analysis included patients who received at least one study drug injection.||(reticulocytes * 10^9/l)*hour||Inter-Quartile Range|Median
1430|NCT02506881|Primary|Cmax|"Maximal concentration of darbepoetin alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis included patients who received at least one study drug injection.||pg/ml||Inter-Quartile Range|Median
1431|NCT02506881|Primary|AUC|Area Under Concentration-time Curve (AUC) of Darbepoetin Alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) Hours and to Infinity(AUC(0-336)/AUC(0-72) and AUC(0-∞) Respectively Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.||(pg/ml)*hour||Inter-Quartile Range|Median
1432|NCT02506257|Other Pre-specified|Conjunctival Examination|Change from baseline conjunctival staining at Day 14. Staining with lissamine green was used. The density of staining was graded with the Oxford Score. Score range was between 0-15. An increase in the score after treatment represent a negative outcome|Baseline and Day 14|||scores on a scale||Standard Deviation|Mean
1433|NCT02506257|Other Pre-specified|Ocular Surface Disease Index-OSDI|Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.|Baseline and Day 14|||scores on a scale||Standard Deviation|Mean
1434|NCT02506257|Other Pre-specified|Visual Acuity|Change from baseline Visual acuity. Best corrected visual acuity was reported in decimal fraction. A decrease of visual acuity during treatment was considered a negative safety outcome.|Baseline and Day 14|||decimals||Standard Deviation|Mean
1435|NCT02506257|Other Pre-specified|Systolic Blood Pressure|Change from baseline systolic blood pressure|Baseline and Day 14|||mmHg||Standard Deviation|Mean
1436|NCT02506257|Secondary|Plasma Concentration of PHMB||Day14|||micrograms/ml||Standard Deviation|Mean
1437|NCT02506257|Primary|Number of Subjects With Dose-limiting Adverse Events||up to 21 days from date of randomization|||participants|||Number
1438|NCT02504775|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||Hours (h)||Standard Deviation|Mean
1439|NCT02504775|Primary|Maximum Plasma Concentration (Cmax)|Cmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||micogram per mililitre (μg/mL)||Standard Deviation|Mean
1440|NCT02504775|Primary|Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]|AUC(0-inf) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis||h*μg/mL||Standard Deviation|Mean
1444|NCT02504320|Primary|Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
1445|NCT02503982|Primary|Area Under the Curve (AUC)|Valganciclovir|drug levels measured at 2, 5 and 10 h following administration of the dose on day 4 creating a 24 hours curve|||mcg∙h/mL||Inter-Quartile Range|Median
1446|NCT02503865|Secondary|Immunoassay Cortisole in Blood|Immunoassay Cortisole in the blood (nmole/L) was measured|up to 12 weeks|||nmol/L||Standard Error|Mean
1447|NCT02503865|Secondary|Immunoassay Hormones in Blood|Immunoassay Insulin in the blood (in nU/L) was investigated|up to 12 weeks|||nU/L||Standard Error|Mean
1448|NCT02503865|Secondary|Lipid Profile|Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured|up to 12 weeks|||mmole/L||Standard Error|Mean
1449|NCT02503865|Primary|Systolic/ Diastolic Blood Pressures (mm Hg)|Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery|up to 12 weeks|||mm Hg||Standard Error|Mean
1450|NCT02503865|Primary|Blood Glucose Level|Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.|up to 12 weeks|||mmole/L||Standard Error|Mean
1451|NCT02503215|Secondary|Change in Fluid Distribution From Baseline|Segmental and total body water will be non-invasively assessed before sleeping and after awakening by a bioimpedance device (InBody S10 Analyser™, Biospace, South Korea), which will provide information regarding nighttime fluid shift at baseline and after compression stocking use. The amount of water, expressed in liters, is assessed in both extra and intracellular components.|1 week|"Volume distribution evaluated by bioimpedance analysis evaluated fluid shift from the legs at baseline and after wearing compression stockings. The amount overnight fluid that moved rostrally from the legs is depicted below (results expressed as mean ± standard deviation):~Baseline: 571.4 ± 389.6 ml~Compression stockings: 517.9 ± 452.2 ml"||mililiters||Standard Deviation|Mean
1452|NCT02503215|Secondary|Change of Heart Rate Variability Change From Baseline|Electrocardiogram performed during polysomnography examination will be downloaded to a specific software for heart rate variability assessment (Kubius HRV™, University of Eastern Finland, Finland), which provides spectral assessment of heart rate variability in its both components: low frequency (LF) and high frequency (HF). Patients who present higher LF/HF during the night compared to the beggining of the polysomnography exam have, by definition, increased sympathetic activity during the night. Such evaluation will be accessed in both baseline and after compression stockings use.|1 week|Overnight increase in LF/HF ratio at baseline: 11/12 patients (92%) Overnight increase in LF/HF ratio after compression stockings use: 7/12 patients (58%)||percentage of participants|||Number
1453|NCT02503215|Primary|Change of Obstructive Apnea Severity Index Score From Baseline|"Apnea/Hypopnea index (AIH) was assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use. The observed results are expressed as median and interquartile range (25,75 percentiles):~AIH at baseline: 20.8 (14.2; 39.6) events/hour;~AIH after compression stockings use: 16.7 (3.5; 28.9) events/hour"|1 week|Apnea/Hypopnea Index||events/hour||Inter-Quartile Range|Median
1454|NCT02502487|Secondary|Breath Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope|||times per minute||Standard Deviation|Mean
1455|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||times per minute||Standard Deviation|Mean
1456|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar Urthra|||times per minute||Standard Deviation|Mean
1457|NCT02502487|Secondary|Breath Rate Before Gel Administration||before gel administration|||times per minute||Standard Deviation|Mean
1458|NCT02502487|Secondary|Oxygen Saturation by Pulse After Withdrawal of Cystoscope||after withdrawal of cystoscope|||percentage||Inter-Quartile Range|Median
1459|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||percentage||Inter-Quartile Range|Median
1460|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra|||percentage||Inter-Quartile Range|Median
1461|NCT02502487|Secondary|Oxygen Saturation by Pulse Before Gel Administration||before gel administration|||percentage||Inter-Quartile Range|Median
1462|NCT02502487|Secondary|Mean Arterial Pressure After Withdrawal of Cystoscope||after withdrawal of cystoscope|||mmHg||Standard Deviation|Mean
1463|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||mmHg||Standard Deviation|Mean
1464|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra|||mmHg||Standard Deviation|Mean
1465|NCT02502487|Secondary|Mean Arterial Pressure Before Gel Administration||before gel administration|||mmHg||Standard Deviation|Mean
1466|NCT02502487|Secondary|Heart Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope|||Beats per minute||Standard Deviation|Mean
1467|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter|||Beats per minute||Standard Deviation|Mean
1468|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urethra|||Beats per minute||Standard Deviation|Mean
1469|NCT02502487|Secondary|Heart Rate Before Gel Administration||before gel administration|||Beats per minute||Standard Deviation|Mean
1470|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|after withdrawal of cystoscope|||units on a scale||Inter-Quartile Range|Median
5072|NCT02226198|Secondary|TG (mmol/L)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
1471|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of prostate and bladder|||units on a scale||Inter-Quartile Range|Median
1472|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of penile and bulbar urethra|||units on a scale||Inter-Quartile Range|Median
1473|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|before gel administration|||units on a scale||Inter-Quartile Range|Median
1474|NCT02502487|Primary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of external sphincter|||units on a scale||Inter-Quartile Range|Median
1475|NCT02502734|Secondary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Number of participants with AEs and SAEs have been presented. Two participants randomized to Sequence 1 (Placebo/FF), were treated with placebo in Period 1; however, neither received FF in Period 2, due to premature withdrawal.|From the start of study treatment until follow-up (assessed up to 54 days)|ITT Population||Participants|||Number
1476|NCT02502734|Primary|Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.|Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medications that may affect short term growth, prior to randomization and during the study; protocol deviations defined in exclusion criteria for growth population. ITT Population consists of all randomized participants who received at least one dose of study drug.|Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.|Growth Population||millimeter per week||Standard Deviation|Least Squares Mean
1477|NCT02500368|Secondary|Conjunctival Staining|Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1478|NCT02500368|Secondary|Conjunctival Indentation|Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|Baseline and 1 week.|||units on a scale||Standard Deviation|Mean
1479|NCT02500368|Secondary|Corneal Staining (Extent)|"Corneal staining extent, grade as % of each zone:~C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior"|Baseline and 1 week|||percentage of cornea||Standard Deviation|Mean
1480|NCT02500368|Secondary|Corneal Dehydration Staining|Corneal Staining: Dehydration Staining: Yes/No|1 week|||participants|||Number
1481|NCT02500368|Secondary|Limbal Hyperemia|Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1482|NCT02500368|Secondary|Bulbar Hyperemia|Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1483|NCT02500368|Secondary|Overall Lens Fit|"Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);~Poor (lens could be worn with supervision only);~Fair (would prefer to refit, but clinically acceptable);~Good (fit could be slightly improved);~Very good (optimal)"|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1484|NCT02500368|Secondary|Ease of Lens Removal|Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.|1 week|||units on a scale||Standard Deviation|Mean
1485|NCT02500368|Secondary|Ease of Lens Insertion|Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1486|NCT02500368|Secondary|Visual Quality|Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1487|NCT02500368|Secondary|Lens Tightness|Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.|Baseline and 1 week|||percentage of tightness||Standard Deviation|Mean
1488|NCT02500368|Secondary|Post-blink Movement|Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)|Baseline and 1 week|||mm steps||Standard Deviation|Mean
1489|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.~(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|1 week|||eyes|Eyes||Number
1490|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.~(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline|||eyes|Eyes||Number
1491|NCT02500368|Secondary|Lens Problems|Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.|Baseline and 1 week|||Lenses|Lenses||Number
1492|NCT02500368|Secondary|Lens Deposition|Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1493|NCT02500368|Secondary|High Contrast Acuity at High Room Illumination|Logarithm of the Minimum Angle or Resolution (LogMAR) Chart|Baseline and 1 week|||LogMAR||Standard Deviation|Mean
1494|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|1 week|||Eyes|Eyes||Number
1495|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|Baseline|||Eyes|Eyes||Number
1496|NCT02500368|Secondary|Lens Wettability|Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1497|NCT02500368|Primary|Dryness|Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1498|NCT02500368|Primary|Comfort|Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
1499|NCT02499692|Secondary|Myocardial Infarction (MI, Q-wave and Non–Q-wave) Rate||30 days|||percentage of participants|||Number
1500|NCT02499692|Secondary|Target Vessel Failure (TVF) Rate||30 days|||percentage of participants|||Number
1501|NCT02499692|Secondary|Target Vessel Revascularization (TVR) Rate||30 days|||percentage of participants|||Number
1502|NCT02499692|Secondary|Target Lesion Failure (TLF) Rate||30 days|||percentage of participants|||Number
1503|NCT02499692|Secondary|Target Lesion Revascularization (TLR) Rate||30 days|||percentage of participants|||Number
1504|NCT02499692|Primary|Technical Success Rate|Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|1 day|||percentage of participants|||Number
1505|NCT02498678|Secondary|Monitor Settings - Sensitivity|Sensitivity calculated by the monitor calibration, It is a numeric value that ranges from 1 to 512, but there is no measurement unit provided. Using the default CAL 2 function, the TOF-Watch® SX monitor automatically determines the sensitivity for a specific patient. The sensitivity can be adjusted between 1 and 512, where 512 represents the most sensitive setting. A sensitivity setting of 157 is the default value. This value represents how the monitor measures motor response of the patient to electrical stimulation of train of four (TOF). If the patient has intense motor response, the monitor reduces its sensitivity. If the patient has poor motor response, the monitor increase your sensitivity.|An expected average of 60 minutes|||units on a scale from 1 to 512||Standard Deviation|Mean
1506|NCT02498678|Secondary|Monitor Settings - Electric Current|Electric current (milliampere) calculated by the monitor calibration|An expected average of 60 minutes|||milliampere||Standard Deviation|Mean
1507|NCT02498678|Secondary|Time to Obtain T1 Height Stability|Time, in minutes, for the stabilization T1 height (maximum acceptable variation of up to 5%) before administration of neuromuscular blocking agent. According to the guidelines for good clinical research practice in pharmacodynamics studies of neuromuscular blocking agents, the monitor must present a stable response of T1 height (baseline) for a period of 2–5 min before administration of an neuromuscular blocking agents.|An expected average of 60 minutes|||seconds||Standard Deviation|Mean
1508|NCT02498678|Primary|T1 Height|T1 height documentation when train of four reaches 0,9 (90%)|An expected average of 60 minutes|||percentage of T1 height||Standard Deviation|Mean
1509|NCT02498678|Primary|Train of Four 0,9 (90%)|Time to recovery to train of four 0,9 (90%). When the fourth stimulus value (T4) divided by the first stimulus (T1) reaches the ratio of 0.9 (T4 / T1)|An expected average of 60 minutes|||minutes||Standard Deviation|Mean
1510|NCT02498522|Primary|Miscarriage Rate||6 months|||participants||95% Confidence Interval|Number
1511|NCT02496533|Secondary|Change in Pulse Rate|A trained clinician will measure and record the subject's radial pulse rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||beats per minute||Standard Deviation|Mean
1512|NCT02496533|Secondary|Change in Respiration Rate in Breaths Per Minute|A trained clinician will measure and record the subject's respiration rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||breaths per minute||Standard Deviation|Mean
1513|NCT02496533|Secondary|Change in Blood Pressure in mmHg|A trained clinician will measure and record the subject's blood pressure using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||mmHg||Standard Deviation|Mean
1514|NCT02496533|Primary|Change in Anxiety as Measured by Visual Analog Scale|Subjects self-reported their perceived anxiety by marking a visual analog scale (VAS). The VAS covers the range 0 to 10. Higher values indicate greater anxiety (worse outcome). Analysis based on difference reported anxiety score between Baseline and after imaging.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.||units on a scale||Standard Deviation|Mean
3073|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population||24 hours|||mean number of tablets taken||Standard Deviation|Mean
1515|NCT02496221|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|Urine dipstick test was carried out on Day -1 and at Follow-up. Urinalysis parameters assessed were glucose, ketones, nitrite and protein. Dipstick results were categorized as Normal (glucose), Negative or Trace (ketones), and Negative (nitrite and protein). Only participants available at the indicated time points (as represented by n=X, X, X in the category titles) were analyzed. The resultant fields with no available data have been represented by 'NA'.|Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects||Participants|||Number
1516|NCT02496221|Secondary|Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgement. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)|All Subjects||Participants|||Number
1517|NCT02496221|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters|Single 12-lead ECG was obtained in a semi-supine position after 5 minutes of rest at each indicated time point using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT, and QT corrected by Fridericia's formula (QTcF) intervals. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)|All Subjects||Milliseconds (msec)||Standard Deviation|Mean
1518|NCT02496221|Secondary|Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance|The following parameters were measured through blood sampling. Hematology: Hematocrit, Hemoglobin, Lymphocytes, Neutrophil Count, Platelet Count, While Blood Cell Count (WBC); Clinical Chemistry: Albumin, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Potassium, Sodium, Total carbon dioxide; Liver Function Tests: Alanine transaminase (ALT), Aspartate transaminase, Alkaline Phosphatase, Total Bilirubin, Total Bilirubin + ALT. Values were considered to be of potential clinical importance if they had a 'low' or 'high' flag with respect to a pre-defined clinical concern range. Only participants starting each period (represented by n=X) with a particular treatment were analyzed. The follow-up time point is not restricted to a treatment or treatment period.|Day -1 in each treatment period and Follow-up (at approximately Week 12)|All Subjects||Participants|||Number
1519|NCT02496221|Secondary|Change From Baseline in Heart Rate|Baseline is defined as Day 1 (pre-dose) visit. Heart rate was measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)|All Subjects||Beats per minute (bpm)||Standard Deviation|Mean
1520|NCT02496221|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline is defined as Day 1 (pre-dose) visit. SBP and DBP were measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 1 (pre-dose), Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1521|NCT02496221|Primary|Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion|Common bile duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable for Bile: Participants with Baseline and post-Baseline common bile duct diameter values for both periods||Centimetre (cm)||Standard Error|Mean
1522|NCT02496221|Primary|Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion|Pancreatic duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error are presented. Baseline was calculated as the value at the indicated time point minus the Baseline value. Only those participants available at the indicated time points were analyzed.|Day 4 in each treatment period|Evaluable for Pancreatic: Participants with Baseline and post-Baseline pancreatic duct diameter values for both periods||Centimetre (CM)||Standard Error|Mean
1523|NCT02496221|Primary|Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects||Minutes||Standard Deviation|Mean
1524|NCT02496221|Primary|Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.|Day 4 in each treatment period|Evaluable Subjects||Millilitre (mL)||Standard Error|Mean
1525|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Volume (AUEC VL)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error is presented.|Day 4 in each treatment period|Evaluable Subjects||mL*min||Standard Error|Mean
1526|NCT02496221|Primary|Maximum Gallbladder Ejection Fraction Value During CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 1 and Day 4 in each treatment period|Evaluable Subjects||Percentage||Standard Error|Mean
1527|NCT02496221|Primary|Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects||Minutes||Standard Deviation|Mean
1528|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects||%*min||Standard Error|Mean
1529|NCT02496221|Primary|Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect|Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects: Participants in the ‘All Subjects’ population who had gallbladder ultrasonography assessment pre-treatment and post-Baseline (during CCK infusion) for both periods. 'All Subjects' population comprised participants who received at least one dose of Investigational product.||Percent of gallbladder EF||Standard Error|Least Squares Mean
1530|NCT02496000|Secondary|The Effect of ORMD-0801 on Changes in HbA1c|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on percent changes from baseline to Wk 4 in HbA1c|Study day 1 (± 1 day) through Study day 29 (± 1 day)||09/2017||||
1531|NCT02496000|Secondary|Effect of ORMD-0801 on Mean Daytime Glucose|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on changes from baseline to Wk 4 of Continuous Glucose Monitoring (CGM) of mean daytime glucose, measured in mg/dL|Study day 1 (±1 day) through Study day 29 (± 1 day)||09/2017||||
1532|NCT02496000|Secondary|The Difference of Mean (mg/dL) Fasting Glucose From Baseline to Week 4|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on absolute changes from baseline to Wk 4 in fasting morning blood glucose.|Study day 1 (± 1 day) through Study day 29 (± 1 day)||09/2017||||
1533|NCT02496000|Secondary|The Effect of ORMD-0801 on Mean 24-hour Glucose|The effect of ORMD-0801 (Dose 1 and Dose 2 individually and pooled) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups measured in mg/dL|Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)||09/2017||||
1534|NCT02496000|Primary|Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.|The Effect of ORMD-0801 (Doses 1 & 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.|Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)|Intend-to-Treat Population, 80% trimming. The mean values will be analyzed using a one-way analysis of variance (ANOVA) model. The residuals from the ANOVA will be analyzed to verify that they are normally distributed. If not normally distributed, then a Kruskal-Wallis test (one-way analysis of variance on the ranks) will be performed.||mg/dL||Standard Deviation|Mean
1535|NCT02495948|Primary|Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear|The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.|Day 30, each product|Intent-to-Treat analysis set||micrograms|Lenses|Standard Deviation|Mean
1536|NCT02495831|Secondary|Relative Bioavailability (Frel)|calculated as ratio between AUC0-t (test) / AUC0-t (reference)|24 hours|||ratio||Standard Deviation|Mean
1539|NCT02495831|Secondary|Evaluate Diclofenac Rate of Absorption Reported as Plasma Cmax After Single Administration of 50 mg Diclofenac With and Without 200 mg of Safinamide.|Cmax, of plasma diclofenamic acid after T2 single dose, with and without T1 co-administration. The parametric point estimators (PE) for the ratios of T2 treatment with T1 co-administration / T2 treatment without T1 co-administration for the PK parameters under consideration, and the two-sided 90% confidence interval (CI), were calculated using the adjusted least squares means (LSMEANS) from the ANOVA. LSmeans differences obtained in the log scale for Cmax were back-transformed to obtain the PE (i.e. geometric mean ratio) and the two-sided 90% CI as percentages.|24 hours|||ng/mL||Standard Deviation|Least Squares Mean
1540|NCT02495831|Primary|To Evaluate Plasma Diclofenamic Acid Extent of Exposure Reported as Plasma AUC After Single Administration of 50 mg Diclofenac Sodium, With and Without Co-administration of a Single 200 mg Dose of Safinamide.|Plasma diclofenamic acid AUC0-t after T2 single dose, with and without T1 co-administration. To measure AUC plasma samples were taken by the participants at different time points, and the concentrations of diclofenac and safinamide were measured. AUC0-t is the area under the concentration-time curve from administration to the last observed concentration time t; PK parameters AUC0-t were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.|24 hours|healthy volunteers||h X ng per mL||Standard Deviation|Mean
1541|NCT02494596|Secondary|Time to Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population||hours||Standard Deviation|Mean
1542|NCT02494596|Secondary|Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is an oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety 5-FU in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5'-DFCR, 5'-DFUR, and FBAL. Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL).|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population||ng/mL||Standard Deviation|Mean
1543|NCT02494596|Secondary|Plasma Half-Life of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). The biological half-life or terminal half-life is the time in days it takes for it to lose half of its pharmacologic activity.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population||hours||Standard Deviation|Mean
1544|NCT02494596|Secondary|Apparent Total Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||mL/day||Standard Deviation|Mean
1545|NCT02494596|Secondary|Apparent Volume of Distribution of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Vss was measured in mL|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||mL||Standard Deviation|Mean
1546|NCT02494596|Secondary|AUC From Time Zero to Infinity (AUC 0-infinity) of Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as nanograms times days per milliliter (ng*day/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||ng*day/mL||Standard Deviation|Mean
1547|NCT02494596|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC was measured as ng*day/mL.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||ng*day/mL||Standard Deviation|Mean
1548|NCT02494596|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. Tmax was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||days||Standard Deviation|Mean
1549|NCT02494596|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and was measured as nanograms per milliliter (ng/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population||ng/mL||Standard Deviation|Mean
1550|NCT02494596|Secondary|Plasma Half-Life (t1/2) of Pertuzumab|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity. t1/2 was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and Predose on Days 8, 15 and 22|ITT population||days||Standard Deviation|Mean
1551|NCT02494596|Secondary|Percentage of Participants With DLTs|DLTs were defined as follows: 1)Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT.|Cycle 1 (3 Weeks)|Safety population||percentage of participants|||Number
1552|NCT02494596|Primary|Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine|MTD was defined as the highest tolerated dose combination of capecitabine (825 mg, 1000 mg or 1250 mg) and pertuzumab, without causing Dose Limiting Toxicities (DLTs). DLTs were defined as follows: 1) Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT. MTD was measured in mg/m^2.|Cycle 1 (3 Weeks)|The Safety Population included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.||mg/m^2|||Number
1553|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound|"The femur length at Five-Dimensional Ultrasound: To obtain 3D volume data, the entire bone length of the femur was identified on the screen, as in the 2D-ultrasound measurement, and the long axis of the femur was placed in the direction of the x axis in the image in which the ultrasound beam was perpendicular to the bone. The 5D LB set key was pressed on the system, wherein the system automatically analyzed the 3D volume data, reconstructed the 3D image of the long bones, and displayed the measured length of the femur length on the screen was measured by pressing 5D LB Button to extract Fetal Long Bones automatically.~then, gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria||weeks||Standard Deviation|Mean
1554|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound|"The femur length at Two-Dimensional Ultrasound (Gold standard) was made from the center of the 'U' shape at each end of the bone. After the long axis of the fetus was identified, the transducer was turned 90 degrees to produce a cross sectional image of fetal trunk, maintaining the 90 degrees angle until the lower spine and iliac crest were identified, then the transducer was rotated until a full femur was imaged. The femur length was measured from the center of the U shape at each end of the bone; this represented the length of the metaphysis).~then , Gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria||weeks||Standard Deviation|Mean
1555|NCT02494440|Primary|Gestational Age Calculated by Accurate Dates of the Last Menstrual Period|"The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy.~Gestational age calculated by the last menstrual period"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria||weeks||Standard Deviation|Mean
1556|NCT02494323|Secondary|Benefit Satisfaction Willingness to Continue (BSW) Questionnaire|Number of subjects who benefited or not benefited from the dual channel electrode was counted, number of patients who were satisfied or not satisfied with the dual channel electrode was counted, number of subjects who were willing to continue or who were unwilling to continue with the dual channel electrode was counted|7 months|Five subjects were excluded from filling up the BSW questionnaire, since the Segmented Electrode (SE) did not produce motor reaction in the ankle||participants|||Number
1557|NCT02494323|Primary|Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE|Subjects were fitted with the L300 Cuff that houses the single channel QFE and then the modified cuff that houses the dual channel segmented electrode. Subjects were stimulated first sitting and then after optimal ankle elevation was achieved, they walked with the stimulation. The clinician documented ankle movement on a 5 point scale: 1-inverted dorsiflexion, 2-slightly inverted dorsiflexion, 3-neutral dorsiflexion,4- slightly everted dorsiflexion, 5- everted dorsiflexion. The clinician documented the number of subjects who achieved each movement with each electrode according to the 5 point scale.|7 months|All subjects suffer from foot drop due to upper motor neuron lesion||units on a scale||Standard Deviation|Mean
1558|NCT02492451|Primary|Pregnancy Rate|ongoing pregnancy rates|12 weeks|||percentage of ongoing pregnancies|||Number
1559|NCT02492165|Primary|Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.||Titers (1/dil)||95% Confidence Interval|Geometric Mean
1560|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
5073|NCT02226198|Secondary|TG (mg/dL)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
1561|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
1562|NCT02492165|Primary|Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|"Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia.~Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years).~Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity."|Day 0 up to Day 14 post-vaccination|Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
1563|NCT02491944|Secondary|CL for [14C]AZD9291|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of total body clearance of drug from plasma after intravascular administration (CL) for [14C]AZD9291.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||L/h||Standard Deviation|Mean
1564|NCT02491944|Secondary|t1/2,λz for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the elimination half life (t1/2,λz) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Standard Deviation|Mean
1565|NCT02491944|Secondary|Tmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the the time to maximum observed plasma concentration (Tmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Full Range|Median
1566|NCT02491944|Secondary|Cmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq||Geometric Coefficient of Variation|Geometric Mean
1567|NCT02491944|Secondary|AUC(0-t) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
1568|NCT02491944|Secondary|AUC(0-120) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
1569|NCT02491944|Secondary|AUC(0-24) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
8445|NCT02093702|Primary|Mean Change in Serum Total Cholesterol||Baseline and 12 months|||mmol/L||Full Range|Mean
1570|NCT02491944|Secondary|AUC for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
1571|NCT02491944|Secondary|CL/F for AZD9291|PK profile of the oral dose of AZD9291 in terms of apparent total body clearance of drug from plasma after extravascular administration(CL/F) for AZD9291.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||L/h||Standard Deviation|Mean
1572|NCT02491944|Secondary|t1/2,λz for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the elimination half life (t1/2,λz) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Standard Deviation|Mean
1573|NCT02491944|Secondary|Tmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the time to maximum observed plasma concentration (Tmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||hours||Full Range|Median
1574|NCT02491944|Secondary|Cmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM||Geometric Coefficient of Variation|Geometric Mean
1575|NCT02491944|Secondary|AUC(0-t) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
1576|NCT02491944|Secondary|AUC(0-120) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
1577|NCT02491944|Secondary|AUC(0-24) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
1578|NCT02491944|Secondary|AUC for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||nM*h||Geometric Coefficient of Variation|Geometric Mean
1579|NCT02491944|Primary|Absolute Oral Bioavailability|Absolute bioavailability of AZD9291 will be calculated from area under the plasma concentration versus time curve (AUC) of the oral dose of AZD9291 / AUC of the IV dose of [14C]AZD9291 x IV dose/Oral dose x 100|Samples taken at pre-dose, 1, 2, 3, 4, 5:45, 5:52, 6, 6:05, 6:10, 6:20, 6:25, 6:30, 7, 8, 9, 10, 12, 14, 16, 18, 24, 30, 48, 72, 120, 168, 216, 336 and 504 hours relative to the oral dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.||Percentage||90% Confidence Interval|Geometric Mean
1580|NCT02491892|Secondary|Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%|Echocardiography was performed to determine LVEF, defined as the volume of blood pumped from the left ventricle as a percentage of end-diastolic volume. Theoretically, LVEF may range from 0 to 100%. The number of participants experiencing a drop in LVEF greater than or equal to (≥) 10 or 15 percentage points to a final LVEF of less than (<) 50% is reported here.|Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion)|Safety Population.||participants|||Number
1581|NCT02491892|Secondary|Mean Residence Time (MRT) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the MRT by non-compartmental analysis. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||days||Standard Deviation|Mean
1582|NCT02491892|Secondary|Volume of Distribution at Steady State (Vss) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the Vss by non-compartmental analysis, defined as the theoretical volume at which the total amount of pertuzumab would be uniformly distributed to produce the desired concentration. The derived value was averaged among all participants and expressed in milliliters (mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||mL||Standard Deviation|Mean
1583|NCT02491892|Secondary|Systemic Clearance (CL) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine CL by non-compartmental analysis, defined as the rate at which pertuzumab was removed from the body. The derived value was averaged among all participants and expressed in milliliters per day (mL/day).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||mL/day||Standard Deviation|Mean
1584|NCT02491892|Secondary|Area Under the Concentration-Time Curve (AUC) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine AUC to the last measurable observation (AUClast) and AUC extrapolated to infinity (AUCinf) by non-compartmental analysis. The derived values were averaged among all participants and expressed in days by micrograms per milliliter (days*mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis, and the number of participants analyzed (n) is presented here.||days*mcg/mL||Standard Deviation|Mean
1585|NCT02491892|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The time of maximum observed pertuzumab concentration across all collection points was documented. Tmax was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||days||Full Range|Median
1586|NCT02491892|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The maximum observed pertuzumab concentration across all collection points was documented. Cmax was averaged among all participants and expressed in micrograms per milliliter (mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||mcg/mL||Standard Deviation|Mean
1587|NCT02491892|Secondary|Apparent Half-Life (t1/2) of Pertuzumab|Serum samples were obtained for pharmacokinetic (PK) assessment using a receptor-binding, enzyme-linked immunosorbent assay (ELISA). Pertuzumab concentrations at each collection point were used to determine the apparent t1/2 by non-compartmental analysis, defined as the time elapsed for pertuzumab concentrations to decrease by 50%. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.||days||Standard Deviation|Mean
1588|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of SD|Objective tumor response was assessed using RECIST. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD. The percentage of participants achieving a best overall response of SD was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
1589|NCT02491892|Secondary|Overall Survival|Overall survival was defined as the time from treatment start to death. Participants who did not die during follow-up were to be censored from the last known alive date. Overall survival was to be estimated using Kaplan-Meier.|Up to approximately 2 years (from start of treatment until death)|Median survival was not reached because the study program was terminated early. Analysis of the incomplete data set was not performed because it could potentially produce skewed or statistically irrelevant data.|||||
1590|NCT02491892|Secondary|Percentage of Participants Who Died|The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 2 years (from start of treatment until death)|Safety Population: All randomized participants who received at least one dose of pertuzumab and had at least one post-baseline safety assessment.||percentage of participants|||Number
1591|NCT02491892|Secondary|Time to Treatment Failure|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Time to treatment failure was defined as the time from treatment start to PD or early withdrawal from the study for death, toxicity, refusal/noncompliance, insufficient therapeutic response, or failure to return. Participants who did not experience PD or who did not withdraw from the study early were censored from the last tumor assessment. Time to treatment failure was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
1655|NCT02483611|Secondary|HR - M7d (Heart Rate in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of heart rate was performed 60 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
1592|NCT02491892|Secondary|Number of Participants Who Experienced PD or Withdrew From the Study Early|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||participants|||Number
1593|NCT02491892|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
1594|NCT02491892|Secondary|Number of Participants Who Experienced PD or Death|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||participants|||Number
1595|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR) to PD or death. Participants who did not experience PD or death were to be censored from the last tumor assessment. Duration of response was to be estimated using Kaplan-Meier.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
1596|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
1597|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR or PR) to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Duration of response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
1598|NCT02491892|Secondary|Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Time to response was defined as the time from treatment start to first documented response (ie, CR or PR). Participants with stable disease (SD) were censored from the last tumor assessment, and those with progressive disease (PD) or death were assigned an artificial censoring time of 1000 days. Time to response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||weeks||Full Range|Median
1599|NCT02491892|Primary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30 percent (%) decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
1600|NCT02490670|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose||Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.||Microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1601|NCT02490670|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose||Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.||hour*microgram per milliliter (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1602|NCT02490475|Secondary|Number of Participants With DLTs|DLTs were defined as any of the following: 1) Any non-hematological toxicity greter than or equal to (≥) Grade 3 according t0 CTCAE version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From Baseline until 4 weeks after the end of treatment|Safety Population||number of participants|||Number
1603|NCT02490475|Secondary|CL for Docetaxel Alone and in Combination With Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per hour per meter squared (mL/h/m^2). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||mL/h/m^2||Standard Deviation|Mean
1604|NCT02490475|Secondary|Vss for Docetaxel Alone and in Combination With Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||mL/m^2||Standard Deviation|Mean
1605|NCT02490475|Secondary|AUC(0-∞) for Docetaxel Alone and in Combination With Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as ng*h/mL. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||ng*h/mL||Standard Deviation|Mean
1606|NCT02490475|Secondary|Cmax for Docetaxel Alone and in Combination With Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||ng/mL||Standard Deviation|Mean
1607|NCT02490475|Secondary|Tmax for Docetaxel Alone and in Combination With Pertuzumab|"Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. When the rate of absorption equals the rate of elimination. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||days||Full Range|Median
1608|NCT02490475|Secondary|t1/2 for Docetaxel Alone and in Combination With Pertuzumab|"The biological half-life or terminal half-life of docetaxel is the time in hours it takes for it to lose half of its pharmacologic activity. Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.||days||Full Range|Median
1609|NCT02490475|Secondary|Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) by Category of Decrease and Timepoint|Ejection fraction (EF) is the fraction of outbound blood pumped from the heart with each heartbeat. It is commonly measured by echocardiogram and serves as a general measure of a person's cardiac function. Changes in LVEF were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. The decrease in LVEF has been categorized as follows: A) Increase, no change, decrease from baseline less than (<) 10%; B) Absolute value <50% and decrease from baseline greater than or equal to (≥) 10%; C) Absolute value <50% and decrease from baseline≥15% ; D) Other. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Baseline, Weeks 7(Cycle 2), 13 (Cycle 4) and Final Visit Up to Week 22|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm, respectively.||percentage of participants|||Number
1656|NCT02483611|Secondary|HR - M7c (Heart Rate in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of heart rate was performed 45 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
1610|NCT02490475|Secondary|Percentage of Participants by Best Overall Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Best Overall response was evaluated as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). CR: complete disappearance of all target lesions. PR: at least a 30 percent (%) decrease in the sum of the longest diameters. SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameters since the treatment started. PD: at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Weeks 7 (Cycle 2),13 (Cycle 4) and Final Visit Up to 22 weeks|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm respectively.||percentage of participants|||Number
1611|NCT02490475|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."||days||Standard Deviation|Mean
1612|NCT02490475|Secondary|Volume of Distribution (Vz) at Steady State of Pertuzumab in Combination With Docetaxel|The volume of distribution at steady state (Vz), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."||mL||Standard Deviation|Mean
1613|NCT02490475|Secondary|Clearance (Cl) of Pertuzimab in Combination With Docetaxel|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."||mL/day||Standard Deviation|Mean
1614|NCT02490475|Secondary|AUC From Time Zero to Infinity (AUC [0-infinity]) for Pertuzumab in Combination With Docetaxel|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as μg*day/mL.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."||μg*day/mL||Standard Deviation|Mean
1615|NCT02490475|Secondary|Area Under the Concentration Curve From Time Zero to the Last Visit (AUC [0-last]) for Pertuzumab in Combination With Docetaxel|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (μg*day/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."||μg*day/mL||Standard Deviation|Mean
1616|NCT02490475|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pertuzumab in Combination With Docetaxel|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as micrograms per milliliter (μg/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. n = number of participants analyzed at the specified timepoint for each arm, respectively.||μg/mL||Standard Deviation|Mean
1617|NCT02490475|Secondary|Plasma Decay Half Life (t1/2) for Pertuzumab in Combination With Docetaxel|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. number (n) equals (=) number of participants analyzed at the specified timepoint for each arm, respectively.||days||Full Range|Median
1628|NCT02485483|Primary|BDI-II Summary Score: VADERA II|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Full analysis set of VADERA II population. Number of participants analyzed = participants with BDI-II summary score assessment at baseline.||scores on a scale||Standard Deviation|Mean
2845|NCT02368314|Primary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.||participants|||Number
1618|NCT02490475|Primary|Maximum Tolerated Dose (MTD) of Docetaxel in Combination of Pertuzumab|A prior dose level was defined as an MTD if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs). If there were no DLTs or DLTs were seen in less than (<) 2 participants in the highest dose level, that was considered as MTD. Participants received escalating doses of docetaxel and pertuzumab until DLTs were observed. DLTs were defined as any of the following: 1) Any non-hematological toxicity ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|Cycle 1 Up to Day 15|Safety Population: included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.||mg/m^2|||Number
1619|NCT02488317|Primary|Preparation for Decision Making|Measured using Bennett, Carol, “Validation of a Preparation for Decision Making Scale.” Patient Education and Counseling 78, no. 1: 130–33 10 item scale, each item scored from 1 (not at all) to 5 (a great deal). items are summed and scored, converted to a 0-100 scale by subtracting 1 from the summed score and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making.|6 months|This was a comparison of the intervention group before and after using the decision aid to assess its impact on preparing the participant for decision making. The question was therefore not administered to the control group since a similar pre/post comparison could not be tested in this group that was not exposed to the intervention.||units on a scale||Standard Deviation|Mean
1620|NCT02488317|Primary|Knowledge|Measured using scale from Cavanaugh K“Patient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis.” Clinical Journal of the American Society of Nephrology 4, no. 5: 950–56) Multiple choice questions with one correct answer per questions. Number of correct questions reported as a percentage of total number of questions (23).|6 months|||scores on a scale||Standard Deviation|Mean
1621|NCT02488317|Primary|Decision Self-efficacy|"Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf O’Connor 1995 Items are scored 0(not at all confident) to 4 (very confident). Scores are summed across 10 items, divided by 10 and multiplied by 25. Scores range from 0-100. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy."|6 months|All participants were included in the analysis.||scores on a scale||Standard Deviation|Mean
1622|NCT02488317|Primary|Decisional Conflict|Measured using the scale from O’Connor, Annette M. “Validation of a Decisional Conflict Scale.” Medical Decision Making 15, no. 1 (February 1, 1995): 25–30. 16 item scale, responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. Mean score per participant is calculated across all items, subtract by 1 and multiplied by 25. Score range= 0-100. Mean scores across all participants in each arm are reported.|6 months|All participants were included in the analysis.||scores on a scale||Standard Deviation|Mean
1623|NCT02488317|Primary|Preference for Shared Decision Making|Measured using the scale from Degner, L. F., Sloan, J. A., & Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43. The CPS is a clinically relevant, easily administered, valid, and reliable measure of preferred roles in health-care decision-making. A pick-one approach was used to identify patient preference for an active, passive or collaborative role in dialysis treatment decision making.|6 months|||participants|||Number
1624|NCT02488018|Primary|Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects|Ten healthy individuals consumed monofloral honeys (25g of available carbohydrate in 250 mL water) after fasting for 11 hours. Blood glucose levels (mmol/L) were recorded at 0, 15, 30, 45, 60, 90 and 120 minutes. Time (0, 15, 30, 45, 60, 90 and 120 minutes) verse blood glucose levels (mmol/L) used to establish the area under the curve (AUC) for the honeys and reference glucose. This was used to calculate the glycemic index of honey each honey (GI= AUC for honey/AUC for reference glucose*100). All 10 participants took eight different honeys and reference glucose on nine different days (with randomized allocation of samples).|36 days (9 tests in 4 days interval)|All 10 participants took, 25g available carbohydrate of eight different honeys and reference glucose, on nine different days in 4 days interval. Blood was taken from finger prick using automatic lancet at 0, 15, 30, 45, 60, 90 and 120 minutes; glucose levels were recorded and area under the blood glucose curve was calculated.||Index||Standard Deviation|Mean
1625|NCT02486952|Secondary|Percentage of Participants Who Were Alive|Percentage of participants with survival was calculated 41 months after the first dose of study treatment.|Up to 41 months|Full analysis population.||percentage of participants|||Number
1626|NCT02486952|Primary|Probability of Event Free Survival (EFS)|EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.|Up to 41 months|Full analysis population.||probability of EFS||95% Confidence Interval|Number
1627|NCT02485483|Primary|Percentage of Participants With Prevalence of Depressive Symptomatology Based on a BDI-II Score Greater Than or Equal to (≥)14 or PHQ-9 Score ≥5: VADERA II|PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a 9-item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27; with 0-4 indicating no depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. BDI-II Scale is a 21-item self-reported questionnaire measuring existence and severity of depression symptoms. Symptoms are each scored on a 4-point scale of 0 (no symptom) to 3 (severe symptom). Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe depression. Participants with a BDI-II score ≥14 or a PHQ-9 score ≥5 were classified as having depressive symptomatology. Participants were evaluated by positive depressive symptomatology for each questionnaire as well as being positive for both questionnaires combined or at least one of the questionnaires.|Baseline|Full analysis set of VADERA II population.||percentage of participants||95% Confidence Interval|Number
5258|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)||prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||||
1629|NCT02485483|Primary|PHQ-9 Summary Score: VADERA II|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Full analysis set of VADERA II population defined as all study participants diagnosed with RA, who had given informed consent, and had completed at least one of the depression questionnaires. Number of participants analyzed = participants with PHQ-9 summary score assessment at baseline.||scores on a scale||Standard Deviation|Mean
1630|NCT02485483|Primary|MADRS at Week 12 ± 2: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging between 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
1631|NCT02485483|Primary|MADRS at Baseline: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging from 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at baseline.||scores on a scale||Standard Deviation|Mean
1632|NCT02485483|Primary|WHO-5 Index at Week 12 ± 2: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
1633|NCT02485483|Primary|WHO-5 Index at Baseline: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at baseline.||scores on a scale||Standard Deviation|Mean
1634|NCT02485483|Primary|BDI-II Score at Week 12 ± 2: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
1635|NCT02485483|Primary|BDI-II Score at Baseline: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at baseline.||scores on a scale||Standard Deviation|Mean
1636|NCT02485483|Primary|PHQ-9 Score at Week 12 ± 2: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with PHQ-9 score assessment at specified time-point.||scores on a scale||Standard Deviation|Mean
1637|NCT02485483|Primary|PHQ-9 Score at Baseline: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Validation analysis set of VADERA I population defined as all study participants diagnosed with RA, who had given informed consent, and had no documented depression at baseline. Number of participants analyzed = participants with PHQ-9 score assessment at baseline.||scores on a scale||Standard Deviation|Mean
1654|NCT02483611|Secondary|HR - M7e (Heart Rate in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of heart rate was performed 75 minutes after the traqueal intubation|||beats/min||Inter-Quartile Range|Median
5893|NCT02188849|Secondary|Twelve Minutes Walk|Measurement of the distance that a participant can walk during 12 minutes|Twelve weeks|||meters||Standard Deviation|Mean
1638|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1639|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1640|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1641|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1642|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1643|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
3074|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population||Cumulative through 12 hours|||mean number of tablets taken||Standard Deviation|Mean
1644|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1645|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1646|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1647|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1648|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1649|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1650|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1651|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions||units on a scale||Standard Deviation|Mean
1652|NCT02484898|Primary|Diagnostic Yield of the SEEQ™ MCT/ECM System||120 Days|Subjects prescribed the SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias||percentage of subjects with CRA||95% Confidence Interval|Number
1653|NCT02483611|Secondary|HR - M7f (Heart Rate in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of heart rate was performed 90 minutes after the traqueal intubation|||beats/min||Inter-Quartile Range|Median
3171|NCT02343380|Secondary|Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
1657|NCT02483611|Secondary|HR - M7b (Heart Rate in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of heart rate was performed 30 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
1658|NCT02483611|Secondary|HR - M7a (Heart Rate in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'.|This measure of heart rate was performed 15 minutes after the traqueal intubation|||beats/min||Standard Deviation|Mean
1659|NCT02483611|Secondary|MAP - M7f (Mean Arterial Pressure in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of average blood pressure was performed 90 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
1660|NCT02483611|Secondary|MAP - M7e (Mean Arterial Pressure in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of average blood pressure was performed 75 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
1661|NCT02483611|Secondary|MAP - M7d (Mean Arterial Pressure in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of average blood pressure was performed 60 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
1662|NCT02483611|Secondary|MAP - M7c (Mean Arterial Pressure in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of average blood pressure was performed 45 minutes after the traqueal intubation|||mmHg||Standard Deviation|Mean
1663|NCT02483611|Secondary|MAP - M7b (Mean Arterial Pressure in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of average blood pressure was performed 30 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
1664|NCT02483611|Secondary|MAP - M7a (Mean Arterial Pressure in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'.|This measure of average blood pressure was performed 15 minutes after the traqueal intubation|||mmHg||Inter-Quartile Range|Median
1665|NCT02483611|Secondary|HR - M6 (Heart Rate in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of heart rate was performed one minute after the tracheal intubation|||beats/min||Standard Deviation|Mean
1666|NCT02483611|Secondary|HR - M5 (Heart Rate in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of heart rate was performed immediately before the tracheal intubation|||beats/min||Standard Deviation|Mean
1667|NCT02483611|Secondary|HR - M4 (Heart Rate in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'.|This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)|||beats/min||Standard Deviation|Mean
1668|NCT02483611|Secondary|HR - M3 (Heart Rate in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)|||beats/min||Standard Deviation|Mean
1669|NCT02483611|Secondary|HR - M2 (Heart Rate in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of heart rate was performed immediately before induction of anesthesia|||beats/min||Standard Deviation|Mean
1670|NCT02483611|Secondary|HR - M1 (Heart Rate in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of heart rate was performed when the patient arrived in the operating room|||beats/min||Standard Deviation|Mean
1671|NCT02483611|Secondary|MAP - M6 (Mean Arterial Pressure in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of average blood pressure was performed one minute after the tracheal intubation|||mmHg||Inter-Quartile Range|Median
3172|NCT02343380|Secondary|Intra-individual Variations in the Values of Leptin After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
1672|NCT02483611|Secondary|MAP - M5 (Mean Arterial Pressure in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of average blood pressure was performed immediately before the tracheal intubation|||mmHg||Inter-Quartile Range|Median
1673|NCT02483611|Secondary|MAP - M4 (Mean Arterial Pressure in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'.|This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)|||mmHg||Inter-Quartile Range|Median
1674|NCT02483611|Secondary|MAP - M3 (Mean Arterial Pressure in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)|||mmHg||Standard Deviation|Mean
1675|NCT02483611|Secondary|MAP - M2 (Mean Arterial Pressure in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of average blood pressure was performed immediately before induction of anesthesia|||mmHg||Standard Deviation|Mean
1676|NCT02483611|Secondary|MAP - M1 (Mean Arterial Pressure in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of average blood pressure was performed when the patient arrived in the operating room|||mmHg||Standard Deviation|Mean
1677|NCT02483611|Primary|Spontaneous Recovery (T4/T1=90%)|"Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium.~This outcome measure was presented in minutes."|The participants were followed during the anesthetic - surgical procedure|||minutes||Standard Deviation|Mean
1678|NCT02483611|Primary|Total Duration (Dur95%)|"The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium.~This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||minutes||Standard Deviation|Mean
1679|NCT02483611|Primary|Final Recovery Index|"The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium.~This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||minutes||Standard Deviation|Mean
1680|NCT02483611|Primary|Recovery Index|"The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium.~This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||minutes||Standard Deviation|Mean
1681|NCT02483611|Primary|Clinical Duration|"The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium.~This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by Kruskal-Wallis test. When differences were found between the groups, we used the Dunn test for multiple comparisons (p value < 0.05)||minutes||Inter-Quartile Range|Median
1682|NCT02483611|Primary|Latency|"The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium.~This outcome meansure was presented in seconds."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)||seconds||Standard Deviation|Mean
1683|NCT02481934|Secondary|Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization|Efficacy will be assessed monthly during NKAE treatment (4 months) by peripheral blood monoclonal protein monitoring. During follow-up, efficacy will be evaluated monthly the first 6 months. After that, quarterly until one year of follow-up.|16 months|||participants|||Number
1684|NCT02481934|Primary|Number of Participants With Adverse Events During NKAE Treatment|Toxicity will be assessed by adverse events count during NKAE treatment monitoring peripheral blood absolute neutrophil count (cells/μl). Toxicity will be evaluated monthly during NKAE treatment (4 months). During follow-up, it will be assessed monthly the first 6 months. After that, quarterly until one year of follow-up, based on Common Toxicity Criteria for Adverse Events of the National Cancer Institute (CTCAE) to v.4.03.|16 months|Analysis per protocol||participants|||Number
1685|NCT02481219|Secondary|Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable CRF|Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.|Full analysis set||percentage of participants with >1 AE|||Number
1686|NCT02481219|Secondary|Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable case report form (CRF)|an expected average of 3 weeks from study procedure|PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake <1h and > 2.15h, Morning PEG intake <1h and >2:15 h, Capsule ingestion l<45 min or >75 min after PEG intake , Overall PEG intake volume is less than 3 liters||percentage of participants|||Number
1687|NCT02481219|Secondary|Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|Per protocol analysis set||percentage of participants|||Number
1688|NCT02481219|Secondary|Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE|Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.||hours||Full Range|Median
1689|NCT02481219|Secondary|Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.||percentage of participants|||Number
1690|NCT02481219|Primary|Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)|The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).|Within two weeks of study procedure|this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.||percentage of particpants|||Number
1691|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute [bpm]).|First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
1692|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose||First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
1693|NCT02480439|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
1694|NCT02480439|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.||ng*hr/mL||Standard Deviation|Mean
1695|NCT02480439|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.||ng*hr/mL||Standard Deviation|Mean
1696|NCT02480439|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.||mg/mL||Standard Deviation|Mean
1697|NCT02480010|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
1698|NCT02480010|Secondary|Volume of Distribution at Steady State of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||mL||Geometric Coefficient of Variation|Geometric Mean
1699|NCT02480010|Secondary|Serum Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||mL/day||Geometric Coefficient of Variation|Geometric Mean
1700|NCT02480010|Secondary|Terminal Elimination Half-Life (t1/2) of Pertuzumab|t1/2 is the time in days required for the concentration of the drug to reach half of its original value|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
1701|NCT02480010|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Cmax refers to the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. tmax is the time at which the Cmax is observed.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1 and on Days 8 and 15, Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population||days||Geometric Coefficient of Variation|Geometric Mean
1702|NCT02480010|Secondary|Maximum Plasma Concentration of Pertuzumab|Cmax is the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. Cmax is measured as micrograms per mL (μg/mL).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1703|NCT02480010|Secondary|AUC to Last Measurable Concentration (AUC0-last) of Pertuzumab|The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
1704|NCT02480010|Secondary|Area Under the Concentration Curve Extrapolated to Infinity (AUC0-Inf) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (µg*day/mL)|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
1705|NCT02480010|Secondary|Change From Baseline in N-Telopeptide|In bone physiology, the N-terminal telopeptide (or more formally, amino-terminal collagen crosslinks, and known by the acronym NTX) is a telopeptide that can be used as a biomarker to measure the rate of bone turnover. NTX can be measured in the urine (uNTX) or serum (serum NTX).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.|||||
1706|NCT02480010|Secondary|Change From Baseline in Bone Alkaline Phosphatase|Bone alkaline phosphatase (BAP) is the bone-specific isoform of alkaline phosphatase. Serum Bone alkaline phosphatase is used to measure osteoporosis and is measured as units per liter (u/L).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.|||||
1707|NCT02480010|Secondary|Time to Treatment Failure|Time to Treatment Failure was time to the first documentation of progressive disease, day of death while on study (or 30 days after withdrawing from the trial) or day of early discontinuation due to toxicity (adverse events or abnormal laboratory value), refusal of treatment/refusing to cooperate/withdrawing consent, insufficient therapeutic response, or failure to return, whichever is earliest, after the start of treatment. Participants who did not experience any of the above events while on study were censored on the day of their last PSA or tumor measurement, whichever was later.|Every 3 weeks up to a maximum of 18 weeks|ITT Population||days||Full Range|Median
1708|NCT02480010|Secondary|Overall Survival|Overall survival was defined as the interval of time in weeks between start of treatment and day of death. Participants who did not die while being followed were censored at the last time that they were known to be alive.|Screening, Every 3 weeks up to a maximum of 18 months|Data were not analyzed due to early termination of the study.|||||
1709|NCT02480010|Secondary|Time to Prostate Cancer Pain Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events: 1) Opioid therapy, 2) Radiation therapy, 3) Glucocorticoid therapy, 4) Radionuclide therapy or 5) Chemotherapy.|Every 3 weeks up to a maximum of 18 weeks|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
1710|NCT02480010|Secondary|Percentage of Participants Without Progression|Disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Non-progression included participants who had responded plus those who had not responded and not progressed within the first 3 cycles.|Screening, Weeks 3, 6, 9 and 12|ITT population||percentage of participants|||Number
1711|NCT02480010|Secondary|Duration of Response According to RECIST Criteria|For participants with measurable disease, duration of response was defined as first documentation of tumor response, either a PR or CR, to first documentation of PD or death. Participants who never progressed or died were censored at their last tumor measurement.|Baseline, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
1712|NCT02480010|Secondary|Duration of Response According to PSA Levels|Duration of PSA Response was measured from first 50% decline in PSA compared to baseline until the time at which there was an increase of ≥50% from the PSA nadir, provided the absolute increase was at least 5 nanograms per milliliter (ng/ml). The increase must have been confirmed by a second consecutive measurement that was at least 50% above the nadir.|Baseline, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
1713|NCT02480010|Secondary|Time to Response|Time to response was the date of the first documentation of PSA response.|Screening, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
1714|NCT02480010|Secondary|Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall objective response by RECIST criteria (CR or PR) was to be defined for participants who had measurable disease at baseline or developed new lesions post-baseline. The longest diameter only for all target lesions was measured and the following responses recorded: CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter as compared to the baseline sum longest diameter.|Screening, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.|||||
1715|NCT02480010|Secondary|Time to Disease Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events. 1) PSA progression as defined by the PSAWG, 2) Evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 3) One bone scan at least 6 months subsequent to baseline demonstrating 2 or more new skeletal lesions and 4) An event due to metastatic prostate cancer requiring intervention.|Screening, Every 3 weeks up to a maximum of 18 months|ITT population||weeks||Full Range|Median
1716|NCT02480010|Primary|Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab|Objective PSA response rate was determined according to Prostate Specific Antigen Working Group (PSAWG) guidelines. All participants achieving a drop in PSA of greater than or equal to (≥) 50 percent (%) from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria of a PSA response. The confirmatory second value had to be at least 50% lower than baseline, but could be higher than the first drop in PSA. Confirmatory value could not be 50% higher compared to first drop in PSA. The date of response was the date the first 50% (or greater) decline was observed. Progressive disease (PD) was defined by a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which documented progressively increasing values. Non-response was defined as neither PD nor Response.|Screening, Every 3 weeks up to Week 24|ITT population||percentage of participants|||Number
1717|NCT02479763|Primary|Percentage of Patients With Successful Epidural Blocks|Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.|up to 15 minutes after the procedure|||percentage of patients|||Number
1718|NCT02478671|Secondary|Hand Perfusion as Measured by Pulse Oxymetry Waveform|pulse oxymetry waveform will be used to measure arterial perfusion|Subjects will be followed up to one week post procedure|||percent saturated||Full Range|Mean
1719|NCT02478671|Primary|MRI Based Radial Artery Measurement|Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.|Subjects will be followed up to one week post procedure|||millimeters||Full Range|Mean
1720|NCT02478580|Secondary|The Ramsey Sedation Score|The Ramsey score at 30 min, 1 hour and 2 after extubation|30 min, 1 hour and 2 hours after extubation||||||
1721|NCT02478580|Primary|Postoperative Care Unit (PACU) Recovery Time|Participants will be followed for the duration of PACU stay, an expected average of 3 hours.|Immediate postoperative period (up to 3 hours)|Patient with obstructive sleep apnea undergoing surgery||Minutes||Standard Deviation|Mean
1722|NCT02478372|Secondary|Total Number of Reported Participants With Complications and/or Adverse Events|The composite number of adverse events reported per group at 30 days and then one year post surgery|30 days and one year post-surgery|||participants|||Number
1723|NCT02478372|Secondary|Patient Reported Outcome Measure - Oxford Knee Score|Units measured on old Oxford Score (12-60) from a 12 point questionnaire. Where in 60 is poor and lower scores are better patient reported outcome scores|one week prior to surgery, 6 weeks post-surgery , one year post-surgery|||units on a scale||Full Range|Median
1724|NCT02478372|Secondary|Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation||On day of discharge from rehabilitation in-patient care (average 96 hours post surgery)|||angle of flexion (degree)||Inter-Quartile Range|Median
1725|NCT02478372|Secondary|Day of Ambulation|Proportion of patients per day to ambulate for the first time with the physiotherapist > 3 Metres|theatre day, day 1 post-surgery, day two post-surgery|||percentage of patients|||Number
1726|NCT02478372|Secondary|Post-operative Nausea and Vomiting Scores|percentage of patients reporting either symptoms of nausea or vomiting over the first 72 hours following surgery. Scale 0-2 wherein 0=no nausea and vomiting, 1=nausea and 2= nausea and vomiting|24hours, 48 hours and 72 hours post-surgery|||percentage of patients reporting PONV|||Number
1727|NCT02478372|Secondary|Post-operative Urinary Catheterisation Rates|% of patients requiring catheterisation for urinary retention post-surgery|72 hours post-surgery|||percentage of patients catheterised|||Number
1728|NCT02478372|Secondary|Verbal Rating Score (VRS) Pain Scores|Summary 24 hour Verbal rated numerical pain scores were gathered each day. Scale range 0-10 where 0 is no pain and 10 is worst imaginable pain|24hours, 48 hours and 72 hours post-surgery|||units on a scale||Standard Deviation|Mean
1729|NCT02478372|Secondary|Average Post-operative Length of Stay|Participants will be followed for the duration of hospital stay, an expected average of 5 days|Average number of days spent in hospital follwoing surgery, an expected average of 5 days|||days||Inter-Quartile Range|Median
1730|NCT02478372|Primary|Proportion of Patients Discharged From Rehabilitation by Day Four|"% of patients meeting predetermined discharge criteria at 96 Hours post-surgery.~The discharge criteria were: self dependent (dress, personal care); in and out of bedd independently; up and down stairs; walk with crutches/stick; 80 degrees knee flexion; able to straight leg raise operated limb."|96 hours|Patients included following randomisation||percentage of patients|||Number
1731|NCT02476422|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death|Treatment emergent adverse events are reported in the below data table.|time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)|Safety analyses were performed on the safety set, which included all randomized subjects who were exposed to study drug.||Participants|||Number
3720|NCT02304926|Secondary|Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration|E-selectin was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||ng/ml||Standard Deviation|Mean
1732|NCT02476422|Secondary|Number of Patients With Different Responses Based on Patient’s Global Assessment of Response to Treatment (PGART)|PGART was measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement was taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period).|At 8 hour postdose prior to use of rescue medication|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.||Participants|||Number
1733|NCT02476422|Secondary|Number of Patients Needing Rescue Medication|The number of patients needing rescue medication within the 8 hour treatment period was evaluated.|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.||Participants|||Number
1734|NCT02476422|Secondary|Duration of Analgesia|Duration of analgesia (time to first use of rescue medication) was evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. Censored observations were included in calculating this endpoint. Censored subjects include any subject who did not take rescue medication prior to the end of the assessment period of 480 minutes (8 hours).|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
1735|NCT02476422|Secondary|Peak Analgesic Effect|"Peak analgesic relief is represented through highest pain intensity difference (PID), highest VASPI reduction, and highest pain relief scores. Pain intensity was measured on a verbal rating scale (VRS) ranging from 0 to 3 (none to severe, with higher score for higher pain intensity). PID represents difference in this score at baseline and specific time points, larger change indicating larger reduction in pain, with highest PID representing the largest difference. Pain relief was recorded on a scale ranging from 0 to 4 (none to complete, with higher score for higher pain relief), with highest pain relief representing maximum relief obtained. Pain intensity was also measured through a 100 mm visual analogue scale (VASPI), ranging from no pain (0 mm) to worst possible pain (100 mm). A positive change in VASPI indicates reduction in pain, with highest VASPI reduction representing highest change."|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Deviation|Mean
1736|NCT02476422|Secondary|Summed Total Pain Relief (TOTPAR) at Different Time Points|"After the administration of the single dose of the assigned study treatment, at the defined study time points, the clinical site staff captured pain relief information from each subject.~The subject was asked “What is the amount of pain relief as compared to the starting pain?” and the response was recorded as 0 = none, 1 = a little, 2 = some, 3 = a lot, or 4 = complete.~Total pain relief (TOTPAR) was the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours were calculated. The weights used for these values (evaluation time points) were 0.25 for the 15-, 30-, 45-, and 60-minute observations, 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Error|Least Squares Mean
1737|NCT02476422|Secondary|Sum of Pain Intensity Difference (SPID)|"At baseline and at each defined study time point, the clinical site staff captured pain intensity information from each subject using the 4-point categorical VRS. The subject was asked~“What is your pain level at this time?” and the response was recorded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Pain intensity difference (PID) was the difference between the baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations were also be done at 1 (SPID1), 2 (SPID2), 4 (SPID4) and 6 (SPID6) hours post dose. The weights used for these values were 0.25 for the 15-, 30-, 45-, and 60-minute observations, and 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Error|Least Squares Mean
1738|NCT02476422|Secondary|Time to Onset of First Perceptible Pain Relief (FPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the first stopwatch as soon as he/she first began to feel 'any' relief from pain. The time elapsed was recorded as the FPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
1739|NCT02476422|Secondary|Time to Onset of Meaningful Pain Relief (MPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the second stopwatch as soon as he/she began to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
1740|NCT02476422|Secondary|Time to Confirmed First Perceptible Pain Relief|Time to onset of first perceptible pain relief (FPR), provided the FPR was subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant started two stopwatches at dosing, and recorded FPR by stopping the first stopwatch when he/she first experienced 'any' pain relief. FPR is ‘confirmed’ only if the participant also stopped the second stopwatch indicating ‘meaningful pain relief’.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.||minutes||Inter-Quartile Range|Median
1741|NCT02476422|Secondary|Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their pain intensity using the 100 mm VASPI to indicate their current level of pain intensity on the 100 mm VASPI labeled “no pain” (0 mm) as the left anchor and~“worst possible pain” (100 mm) as the right anchor. A positive change shows reduction in pain.~AUC of VASPI reduction from baseline for each time point was calculated using the trapezoidal rule."|15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale*hours||Standard Error|Least Squares Mean
1742|NCT02476422|Secondary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||Units on a scale||Standard Error|Least Squares Mean
1743|NCT02476422|Primary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|60 minutes postdose|The efficacy analyses were performed on the full analysis set (FAS) which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.||units on a scale||Standard Error|Least Squares Mean
1744|NCT02475980|Secondary|Follow-up Adherence|Proportion of girls who present for follow-up appointment after referral to Adolescent Gynecology outpatient clinic|4 weeks after enrollment|Number of participants given a referral to Adolescent Gynecology in PED||participants|||Number
1745|NCT02475980|Secondary|Descriptive Statistics of Participants|Frequencies and descriptive statistics of participant demographics, comorbidities associated with unintended adolescent pregnancy, and contraceptive use|At conclusion of study data collection, approximately 8 weeks after enrollment|Participants consented for project||participants|||Number
1746|NCT02475980|Primary|Contraceptive Initiation|Proportion of participants who report initiating contraception or changing to a more effective method of contraception|4 weeks after enrollment|Of the 13 girls consented to the study, 1 initiated a new contraception method following the intervention.||participants|||Number
1747|NCT02475980|Primary|Participant Satisfaction|Participant ratings of acceptability of contraceptive counseling in the emergency department and satisfaction with counseling|4 weeks after enrollment|Number of girls available for follow-up at 4-week phone call.||participants|||Number
1748|NCT02475980|Primary|Proportion of Eligible Girls Offered Counseling Intervention|Proportion of girls eligible to participate in study who were offered contraceptive counseling|Approximately 4 weeks after enrollment|||participants|||Number
1749|NCT02475980|Primary|Length of Stay|Emergency department length of stay for participants|Measured at time of chart review for patient follow-up, approximately 4 weeks after enrollment.|||minutes||Full Range|Median
1750|NCT02475564|Secondary|Serum Prolactin Levels at 42 Days|Serum levels of prolactin will be measured after 42 days of treatment. Median levels of prolactin were compared between both groups on day 42.|42 days|one of the subjects in the placebo group decided to leave the study after randomization, thus n = 21||ng/mL||Full Range|Median
1751|NCT02475564|Secondary|Serum CA125 Levels at 42 Days|Serum levels of CA125 will be measured after 42 days of treatment in UI/mL. Median levels of CA125 were compared between both groups on day 42, and to baseline values (day 1).|42 days|One of subjects from the placebo group decided to leave the study after randomization, thus the n = 21 in the CA125 levels.||UI/mL||Full Range|Median
1752|NCT02475564|Primary|Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.|Pain will be measured by VAS (visual analog scale) as baseline and at the end of the study, considering the last 7 days. VAS was used to measuring pain intensity, ranging continuously from 0 (no pain) to 10 (worst imaginable pain). The main outcome compared median pain levels between both arms on day 42.|42 days|Intention to treat analysis, patients who were lost on follow-up had their last registry on pain values or plasma levels measurements repeated in the following consultations.||units on a scale||Full Range|Median
1753|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 29 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.|Day 29|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||participants|||Number
1754|NCT02475278|Secondary|Percentage of Participants Experiencing Serious Adverse Events|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 183|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
1791|NCT02471755|Secondary|Change of E2 From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||pmol/l||Inter-Quartile Range|Median
1755|NCT02475278|Secondary|Percentage of Participants With Unsolicited Adverse Events (AEs) by Maximum Severity|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Unsolicited AEs are presented as the percentage of participants experiencing at least one AE, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 28|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
1756|NCT02475278|Secondary|Percentage of Participants With Elevated Daily Oral Temperature|Safety assessment included measurement of body temperature for 7 days following vaccination (including the day of vaccination) by using diary cards. Participants recorded the highest body temperature observed each day in a daily diary. The highest body temperature measurement per participant across Day 1 to Day 7 was categorized as fever present (≥100.4ºF, ≥38ºC) or fever absent (<100.4ºF, <38ºC).|Days 1 to 7 days after vaccination|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
1757|NCT02475278|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited systemic AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting and diarrhea and are summarized as either none or any, where ‘any’ will be broken down into the following severity categories: mild, moderate, severe. Solicited systemic AEs are presented as the percentage of participants experiencing a solicited systemic AE, by AE, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
1758|NCT02475278|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited local AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited local injection site AEs are defined as pain, erythema (redness), induration and swelling. Pain is summarized as either none or any, where ‘any’ will be broken down into the following severity categories: mild, moderate, severe. Erythema, swelling and induration are recorded as yes or no, where the definition of ‘yes’ is any area ≥2.5 cm; and ‘yes’ is further broken down into the following severity categories: ≥2.5 cm - ≤5.0 cm (mild intensity), >5.0 cm - ≤ 10.0 cm (moderate intensity), >10.0 cm severe intensity). Injection site AEs are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||percentage of participants|||Number
1759|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 15 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.|Day 15|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||participants|||Number
1760|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.|Day 8|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).||participants|||Number
1761|NCT02473510|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Percentage of Participants|||Number
1762|NCT02473510|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported within 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and 181|The ITT population included all participants that were randomized and treated with investigational product.||Participants|||Number
1763|NCT02473510|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported within 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Participants|||Number
1792|NCT02471755|Secondary|Change of FSH/LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||ratio||Inter-Quartile Range|Median
3774|NCT02300129|Primary|Total Number of Flushes for Each 2-week Period||Day 22 and Day 36/Early termination|Per protocol population of Period 2, N= 31||Flushes count||Standard Deviation|Mean
1764|NCT02473510|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 8 days after vaccination and all solicited symptoms within 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.||Percentage of Participants|||Number
1765|NCT02473510|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.||Percentage of Participant|||Number
1766|NCT02473367|Primary|Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Least Squares Mean
1767|NCT02473367|Primary|Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Least Squares Mean
1768|NCT02473367|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.||hr*µM||95% Confidence Interval|Least Squares Mean
1769|NCT02472847|Primary|BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean BOLD hippocampal signal during extinction learning and retention task in brain responsebetween the placebo (PBO) and the dronabinol (THC) group. Target areas are analyzed from fMRI scans. The scans were completed on days 1, 2, 3, and 9. Participants were randomized to the PBO and THC condition and received either placebo or dronabinol on day 2, 2 hours prior to extinction learning. Data from days 1, 2, 3, & 9 was combined and a single value was averaged for each group.|Day 1, 2, 3, & 9|The number of participants analyzed is 22 in the placebo group and 18 in the dronabinol group. The total number of participants who completed all 4 scanning sessions is 44. 4 participants were excluded from data analysis due to having poor quality fMRI data from any of the four sessions.||parameter estimates (arbitrary units)||Standard Deviation|Mean
1770|NCT02472756|Primary|Percentage of Participants Who Were Alive at Year 2||Year 2|ITT population.||percentage of participants|||Number
1771|NCT02472756|Primary|Percentage of Participants With Complete Remission (CR)|Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline).|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
1793|NCT02471755|Secondary|Change of LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||mIU/ml||Inter-Quartile Range|Median
1794|NCT02471755|Secondary|Change of FSH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20|||mIU/ml||Inter-Quartile Range|Median
1772|NCT02472756|Primary|Percentage of Participants With Objective Response|Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD.|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|Intent-to treat (ITT) population. Number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
1773|NCT02472522|Post-Hoc|Percentage of Patients Needing Rescue Analgesic|Percentage of patients needing rescue analgesic. Rescue analgesia was provided with 6 mg of intravenous morphine and additional doses of 3 mg at 10 minutes interval till VAS was less than 3 or the development of adverse effects such as nausea and/or vomiting, respiratory depression (SpO2 <92%, ventilatory frequency rate <10), or occurrence of deep sedation (eyes closed >3 min, Ramsay Score RS >2).|24 hours|||percentage needing rescue analgesic|||Number
1774|NCT02472522|Other Pre-specified|Short Assessment of Patient Satisfaction Score (SAPS)|"Short assessment of patient satisfaction score(SAPS) was assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. where:~highly dissatisfied~dissatisfied~neither dissatisfied nor satisfied~satisfied~highly satisfied"|24 hours|||Units on a scale||Standard Deviation|Mean
1775|NCT02472522|Other Pre-specified|Visual Analogue Scale on Coughing (VAS-C)|Visual Analogue Scale on Coughing (VAS-C) Was Used to Assess Post-operative Pain on Coughing. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours|||Units on a scale||Standard Deviation|Mean
1776|NCT02472522|Other Pre-specified|Visual Analogue Scale at Rest (VAS-R)|Visual Analogue Scale at rest (VAS-R) was used to assess Post-operative Pain at rest. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours|||Units on a scale||Standard Deviation|Mean
1777|NCT02472522|Other Pre-specified|Heart Rate: Postoperative|The Heart Rate of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours|||beats/minute||Standard Deviation|Mean
1778|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Postoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1779|NCT02472522|Other Pre-specified|Duration of Sensory Loss at T10 Level|The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes.|24 hours|||minutes||Standard Deviation|Mean
1780|NCT02472522|Other Pre-specified|Time to Complete Disappearance of Motor Block|"During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles~= able to move knees, unable to raise extended legs~= able to flex ankles, unable to flex knees~= unable to move any part of the lower limb The time from subarachnoid block to complete disappearance of motor block (Bromage 0) was recorded in minutes."|24 hours|||minutes||Standard Deviation|Mean
1781|NCT02472522|Other Pre-specified|Heart Rate: Intraoperative Period|The Heart Rate of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|60 minutes|||beats/minute||Standard Deviation|Mean
1782|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Intraoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|Upto 60 minutes|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1783|NCT02472522|Secondary|Adverse Effects Like Pruritus, Nausea and Vomiting||24 hours|||participants|||Number
1784|NCT02472522|Secondary|Total Dose of Required Morphine in 24 Hours Postoperatively||24 hours|Only the mentioned number of patients needed analgesia within the first 24 hours postoperatively||Milligrams||Standard Deviation|Mean
1785|NCT02472522|Primary|The Time After the TAP Block When Rescue Analgesia Was First Sought||24 hours|Number of patients who sought rescue analgesic within the first 24 hours postoperatively. Rest of the studied patients needed no rescue analgesic within the first 24 hours postoperatively.||Hours||Standard Deviation|Mean
1786|NCT02472366|Post-Hoc|Change in Best Corrected Visual Acuity From Baseline|A subgroup analysis was performed in which only pseudophakic subjects were included. Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
1787|NCT02472366|Secondary|Changes in Macular Volume||Change from Baseline to 12 months post ILUVIEN administration|"For laser arm group, 6 patients were enrolled with 7 eyes receiving ILUVIEN"||mm^3|Participants|Standard Deviation|Mean
1788|NCT02472366|Secondary|Changes in Central Subfield Thickness||Change from Baseline to 12 months post ILUVIEN administration|"For Laser arm group, there were 6 patients enrolled but 7 eyes treated"||microns|Participants|Standard Deviation|Mean
1789|NCT02472366|Secondary|Changes in Intraocular Pressure (IOP)||Change from Baseline to 12 months post ILUVIEN administration|"for laser arm group, 6 patients enrolled with 7 eyes receiving ILUVIEN"||mmHg|Participants|Standard Deviation|Mean
1790|NCT02472366|Primary|Changes in Best Corrected Visual Acuity From Baseline|Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
5382|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1795|NCT02471755|Secondary|Change of MRS (Menopause Rating Scale) From Baseline|MRS(Menopause Rating Scale) was designed to measure MT symptoms and to explore the influences on life qualities in a standardized way. In MRS, symptoms such as impaired memory, depression, insomnia, sweating, hot flashes, nervousness, joints complaints, lack of concentration were evaluated and calculated in numbers to describe the situation of patient. Scores on MRS range from 0 to 44, with higher scores indicating more severe symptoms.|week8;wee4,20,32|||Scores on a scale||Inter-Quartile Range|Median
1796|NCT02471755|Primary|Change of Average 24 h Hot Flash Score From Baseline|Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.|week8;wee4,20,32|||Scores on a scale||Inter-Quartile Range|Median
1797|NCT02471612|Secondary|Patients Needing Re-exploration|Number of patients needing return to the operation theater for surgery for the same pathology or any other complication arising out of the initial surgery|30 days|||participants|||Number
1798|NCT02471612|Secondary|Number of Participants With Acute Kidney Injury (AKI)|"Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines~Increase in Serum Creatinine (S. Cr) by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR~Increase in S. Cr to ≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR~Urine volume <0.5 ml/kg/h for 6 hours"|30 days|||participants|||Number
1799|NCT02471612|Secondary|Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)|Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment|30 days|||participants|||Number
1800|NCT02471612|Secondary|Need for Post Operative Inotropic Support|Number of patients needing post-operative inotropic support|30 days|||participants|||Number
1801|NCT02471612|Secondary|Need for Postoperative Ventilator Support|Number of patients needing post-operative ventilatory support|30 days|||participants|||Number
1802|NCT02471612|Secondary|Length of Stay (LOS)|The mean duration of hospital stay or Length of Stay was recorded|30 days|||Days||Standard Deviation|Mean
1803|NCT02471612|Primary|Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality|Participants will be followed for the duration of hospital stay (expected average of 30 days) and mortality was noted.All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II and P-POSSUM scoring systems on the day of surgery. Area under the curve (AUC) is used to measure the “size” of the prediction composed by the graphic display between the ‘sensitivity’ and the ‘1–specificity’ relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value > 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value < 0.60 is regarded as poor. For APACHE-II, a cut off score of >/=24 was determined; for P-POSSUM, a cut off score of >/= 63 was determined.|30 days|All patients undergoing emergency laparotomy at Tata Main Hospital form December 2013 to November 2014 were scored with APACHE II & P-POSSUM scoring systems on the day of surgery. The patients were followed up till at least 30 days after discharge or death (during admission or within 30 days after discharge).||probability of accurate prediction||95% Confidence Interval|Number
1804|NCT02470949|Primary|Percent of Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart|||percent||Standard Deviation|Mean
1805|NCT02470949|Primary|The Macronutrient Composition of Foods Consumed|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart|||grams||Standard Deviation|Mean
1806|NCT02470949|Primary|Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 20 minutes following the completion of their manipulated social status condition.|Administered 30 days apart|||kcal||Standard Deviation|Mean
1807|NCT02469961|Secondary|Total Narcotic Used by Each Participant|the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|||Microgram||Standard Deviation|Mean
1808|NCT02469961|Secondary|Number of Participants That Have Either Bradycardia or Hypotension|Number of participants observed with Bradycardia or Hypotension who required intervention|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|Number of patients who had Bradycardia or hypotension||participants|||Number
1809|NCT02469961|Secondary|Post Anesthesia Care Unit (PACU) Length of Stay|length of stay in minutes in the Post Anesthesia Care Unit before discharge|Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation|||Minutes||Standard Deviation|Mean
1810|NCT02469961|Primary|Number of Participants That Need an Airway Intervention.|airway manipulation or repositioning: apnea, oral airway, adjust head|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|||participants|||Number
1811|NCT02469597|Secondary|Length of Hospital Stay||Participants will be followed for the duration of hospital stay up to 1 week|||Days||Standard Error|Least Squares Mean
1812|NCT02469597|Secondary|Patient Needing Endotracheal Intubation||Within 72 hours of medication administration|||participants|||Number
1813|NCT02469597|Primary|Oxygen Saturation||4 hours after medication adminstration|||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
1814|NCT02469597|Primary|Oxygen Saturation||2 hours after medication adminstration|||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
1815|NCT02469597|Primary|Respiratory Rate||4 hours after medication adminstration|||Percentage change in respiratory rate||Standard Error|Least Squares Mean
1816|NCT02469597|Primary|Respiratory Rate||2 hours after medication adminstration|||Percentage change in respiratory rate||Standard Error|Least Squares Mean
1817|NCT02469116|Other Pre-specified|Adverse Events as Measured by Number of Events Experienced by All Participants||30 days after completion of treatment (approximately 22 weeks)|||events|||Number
1818|NCT02469116|Secondary|Quality of Life (QoL) as Measured by FACT-O Assessment Tool|"The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section~Answers range from Not at all to Very Much with 0 = not at all and 4 = very much"|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
1819|NCT02469116|Secondary|Progression-free Survival (PFS)|-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
1820|NCT02469116|Secondary|Overall Survival (OS)|Overall Survival is the observed length of life from entry into the study to death or the date of last contact|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
1821|NCT02469116|Secondary|Time to Progression (TTP)|Progressive disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Unequivocal progression of existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, in the opinion of the treating physician within 8 weeks of study entry is also considered increasing disease (in this circumstance an explanation must be provided). In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in the LD is required.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.|||||
1822|NCT02469116|Secondary|Efficacy of Regimen as Measured by CA-125 Response|"Progression is defined as one of the following:~Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 ≥ twice the upper limit of normal on two occasions at least one week apart~Patients with elevated CA-125 pretreatment which never normalizes must show evidence of CA-125 ≥ 2 times the nadir value OR > 50% increase from the nadir on two occasions at least one week apart,~Patients with CA-125 in the normal range pretreatment must show evidence of CA-125 ≥ two times the upper limit of normal on two occasions at least one week apart.~Complete response is defined as a CA-125 value <13 confirmed on two occasions at least 2 weeks apart.~Partial Response is defined as a reduction of at least 50% from the original elevated CA-125 value (original value must have been > 50), confirmed on two occasions at least 2 weeks apart.~Stable Disease is defined as not meeting one of the above criteria."|Completion of treatment (approximately 18 weeks)|||participants|||Number
1823|NCT02469116|Primary|Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3||Through 30 days after completion of treatment (approximately 22 weeks)|||participants|||Number
1824|NCT02468154|Secondary|Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10|The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived|one time at cast removal (expected average of 30 days).|||units on a scale||Standard Deviation|Mean
1825|NCT02468154|Secondary|Health Staff/Caregiver Interventions|daily number of interventions by health staff /caregiver to maintain the cast in an off-loaded position, marked on a form given daily to the family/caregiver|up to the first 2 days during hospitalization|||daily number of interventions||Standard Deviation|Mean
1826|NCT02468154|Secondary|Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel –N.P.U.A.P.||one time at cast removal (expected average of 30 days).|||participants|||Number
1827|NCT02468154|Primary|"Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group"|All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain|up to the first 2 days during hospitalization and at cast removal (maximum 30 days).|||units on a scale||Standard Deviation|Mean
1828|NCT02467491|Secondary|Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in 4 weeks to 3 months|||units on a scale||Standard Deviation|Mean
1829|NCT02467491|Secondary|Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in baseline to 4 weeks|||units on a scale||Standard Deviation|Mean
1830|NCT02467491|Primary|Global Appreciation Score|"The global appreciation score is a measure of feasibility.~This score will be derived from each participant's answer to the first question of a 9-item acceptability questionnaire. The second question of the questionnaire is :How much did you like Jintronix?, participants' answer may be:~I didn't like it (0 point)~A little (1 points)~Moderate (2 points)~A lot (3 points). The global appreciation score is the sum of the points obtained by each participants.~The global appreciation score for 12 participants may range from 0 (no appreciation) to 36 (a lot of appreciation).~In order to say that Jintronix is feasible we expected a global appreciation score for 12 participant after 4 weeks of intervention to be > 24."|4 weeks|||units on a scale|||Number
1831|NCT02467491|Primary|Global Difficulty Score|"The global difficulty score was another measure of acceptability.~The global difficulty score will be derived from each participant's answer to the second question of a 9-item feasibility questionnaire. The second question of the questionnaire is :How difficult did you find the Jintronix?, participants' answer may be:~Very difficult (3 point)~Quite difficult (2 points)~Not at all (1 points)~No difficulty (0 points). This means that the global difficulty score for 12 participants may range from 0 (no difficult) to 36 (very difficult).~We expected to find a global difficulty score < to 15 in order to say that Jintronix was acceptable."|4 weeks|||units on a scale|||Number
1852|NCT02462291|Secondary|Blood Glucose (mg/dl)|A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.|PRE and POST 6 months of treatment|||(mg/dl)||Standard Deviation|Mean
1853|NCT02462291|Secondary|Diastolic Blood Pressure (mmHg)|Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment|||(mmHg)||Standard Deviation|Mean
1832|NCT02467491|Primary|Total Average Time in Performing Exercises With Jintronix.|"Each participant has to perform the exercise program with Jintronix for 30 minutes per session, for 2 times/week for a total of 4 weeks.~This means that each participant has to be able to perform a maximum of 240 minutes of exercises for 4 weeks.~Jintronix calculated automatically the time (minutes) in performing the exercises for each participant at the end of the 4 weeks of intervention.~As a measure of acceptability we calculated the total average time in performing the exercises for the 12 participants for 4 weeks by summing the minutes in performing the exercises for each participants for 4 week and dividing it for 12.~We expected to find an average total time in performing the exercises for 12 participants > 192 minutes (3.2 hours) out of a total of 240 minutes (4 hours) in order to say that Jintronix was acceptable."|4 weeks|||minutes||Standard Deviation|Mean
1833|NCT02467491|Primary|Quality of Movements' Total Average Score|"The quality of movements’ score is a measure of feasibility. The quality of movement's score is automatically calculated by Jintronix for each participant at the end of the intervention program with Jintronix.~A quality of movement's score of 100% means that the participant performed the exercise perfectly.~To calculate the quality of movements' total average score for the Group (made of 12 participants), we summed the quality of movements' score for each participants and divided it for 12. We expected to find a total average quality movements' score>80% in order to say that Jintronix was feasible."|4 weeks|||percentage of quality of movements||Standard Deviation|Mean
1834|NCT02465489|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 36 or early termination)|The safety population included all subjects who received at least one of the investigational products under study||participants|||Number
1835|NCT02465489|Primary|AUC0-∞for Serum Deferiprone|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose.|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods||ug*h/mL||Standard Deviation|Mean
1836|NCT02465489|Primary|Tmax for Serum Deferiprone|Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods||Hour||Standard Deviation|Mean
1837|NCT02465489|Primary|Cmax for Serum Deferiprone|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods.||μg/mL||Standard Deviation|Mean
1838|NCT02465073|Primary|The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care||Percentage after 4 weeks|||percentage of participants|||Number
1839|NCT02463331|Secondary|Histopathological Response to Therapy|Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.|liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response|The histological response was only evaluated in the patients with biochemical remission, since in the patients without biochemical response it was already known that there would be activity in the liver tissue.||Participants|||Count of Participants
1840|NCT02463331|Primary|Biochemical Response to Therapy|The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.|six months|||Participants|||Count of Participants
1841|NCT02462291|Secondary|Number of Patients Treated With Ticlopidin||PRE and POST 6 months of treatment|||Participants|||Number
1842|NCT02462291|Secondary|Number of Patients Treated With Memantine||PRE and POST 6 months of treatment|||Participants|||Number
1843|NCT02462291|Secondary|Number of Patients Treated With Donepezil||PRE and POST 6 months of treatment|||Participants|||Number
1844|NCT02462291|Secondary|Number of Patients Treated With Citalopram||PRE and POST 6 months of treatment|||Participants|||Number
1845|NCT02462291|Secondary|Number of Patients Treated With Quetiapine||PRE and POST 6 months of treatment|||Participants|||Number
1846|NCT02462291|Secondary|Number of Medications||PRE and POST 6 months of treatment|||Number of Medications||Standard Deviation|Mean
1847|NCT02462291|Secondary|Salivary Cortisol (Nmol/l)|Levels of cortisol was measured via saliva samples using plain Sarstedt Salivette collection devices (Nümbrecht, Germany). Samples will be collected at 6.30 AM, 11.30 AM, and 6.30 PM. Immediately after collecting the saliva samples, were centrifuged for 2 min at 1,000 rpm. Purified saliva was stored in a freezer at -20 °C, and subsequently analyzed. Cortisol levels was determined by a time-resolved immunoassay with fluorometric detection.|PRE and POST 6 months of treatment|||(nmol/L)||Standard Deviation|Mean
1848|NCT02462291|Secondary|Evaluation of Activity of Daily Life|Independence and level of activities of daily life (ADL) were evaluated with the Barthel index. Levels of ADL was measured by observing each resident’s daily activities (eating, bathing, grooming, dressing, transfers from bed to chair, mobility on level planes, stairs, and getting on/off the toilet). The total score of the Barthel index is 0-100, and higher values represent a better outcome.|PRE and POST 6 months of treatment|||Scores on a scale||Standard Deviation|Mean
1849|NCT02462291|Secondary|Daily Energy Expenditure (Kcal/Day)|Daily energy expenditure was measured with an Actiheart device (CamNtech, Cambridge, UK) allowing heart rate and acceleration data to be simultaneously recorded for 24 h/day for 7 consecutive days.|PRE and POST 6 months of treatment|||(Kcal/day)||Standard Deviation|Mean
1850|NCT02462291|Secondary|Blood Cholesterol LDL (mg/dl)|A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment|||(mg/dl)||Standard Deviation|Mean
1851|NCT02462291|Secondary|Blood Cholesterol HDL (mg/dl)|A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment|||(mg/dl)||Standard Deviation|Mean
1855|NCT02462291|Secondary|Body Composition (Kilograms of Fat Free Mass)|Body mass and skin-fold measurements were measured three times a day by the same experienced operator. The average value of the three measurements was calculated. Kilograms of fat free mass was estimated using a validated equation.|PRE and POST 6 months of treatment|||kg||Standard Deviation|Mean
1856|NCT02462291|Primary|Evaluation of Cognitive Status (Score 0-30)|Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome.|PRE and POST 6 months of treatment|||Scores on a scale||Standard Deviation|Mean
1857|NCT02462291|Primary|Evaluations of Behavioral Disorders|Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome.|PRE and POST 6 months of treatment|||Scores on a scale||Standard Deviation|Mean
1858|NCT02461992|Other Pre-specified|Number of Participants With Positive FVIII Inhibitor Activity at Day 4|As with all FVIII products, participants using Xyntha were monitored for the development of FVIII inhibitors. Values >= 0.6 Bethesda Unit (BU) per mL were considered positive results.|Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
1859|NCT02461992|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <50 beats per minute (bpm), >=30 bpm increase from baseline, or >25 bpm decrease from baseline; systolic blood pressure (SBP) <90 milliliters of mercury (mmHg), >=30 mmHg increase from baseline, or >=30 mmHg decrease from baseline; diastolic blood pressure (DBP) <50 mmHg, >=20 mmHg increase from baseline, or >=20 mmHg decrease from baseline.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
1860|NCT02461992|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, RBC morphology, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine drug screening, FVIII inhibitor assay, FVIII activity, prothrombin time [PT], activated partial thromboplastin time [APTT], anti-human immunodeficiency virus [HIV] 1, hepatitis C virus antibody [HCVAb], HAVAb, HBsAg, HBsAb, HBcAb). Only parameters which met abnormality criteria are reported.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
1861|NCT02461992|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 28|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
1862|NCT02461992|Primary|Incremental Recovery (INCREC)|Incremental recovery is the increase in circulating FVIII activity for every IU of Xyntha administered per kilogram of body weight.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU/deciliter (dL) per IU/kg||Geometric Coefficient of Variation|Geometric Mean
1863|NCT02461992|Primary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||hour||Geometric Coefficient of Variation|Geometric Mean
1864|NCT02461992|Primary|Terminal Elimination Half-Life (t1/2)|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||hour||Standard Deviation|Mean
1865|NCT02461992|Primary|Terminal Phase Rate Constant (Kel)|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural­-logarithm transformed concentration-­time profile.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||1/hour||Geometric Coefficient of Variation|Geometric Mean
1866|NCT02461992|Primary|Volume of Distribution at Steady-State (Vss)|Volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the volume of distribution at steady-state.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2100|NCT02441218|Primary|Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.|Number of patients having experienced the Primary Composite Endpoint.|All over the study (up to 42 months).|||participants|||Number
1867|NCT02461992|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||mL/hour/kg||Geometric Coefficient of Variation|Geometric Mean
1868|NCT02461992|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||hour||Full Range|Median
1869|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1870|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1871|NCT02461992|Primary|Maximum Plasma FVIII Activity (Cmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.||IU/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1872|NCT02461290|Secondary|Percentage of Participants Alive at 1, 2, and 3 Years|Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as [number of participants alive divided by the number analyzed] multiplied by 100.|At 1, 2, and 3 years|ITT Population.||percentage of participants|||Number
1873|NCT02461290|Secondary|Percentage of Participants With CR According to International Working Group Response Criteria for NHL|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population.||percentage of participants|||Number
1874|NCT02461290|Secondary|Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population: All enrolled participants who provided complete and evaluable outcome data.||percentage of participants|||Number
1875|NCT02461290|Primary|Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE|The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.|Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|ITT Population.||participants|||Number
1876|NCT02460458|Primary|Type of VWF/FVIII-containing Concentrates in Use|Record of any VWF/FVIII-containing concentrates used and currently in use, including the current schedule type of treatment.|24 months (prospective phase)||||||
1877|NCT02460458|Primary|Adverse Events|Record of all adverse events occurred during the prospective phase of the study.|24 months (prospective phase)||||||
1878|NCT02460458|Primary|Record of Bleeding Episodes|Bleeding: severity, start date, stop date; Treatment: Product name, start date, stop date, Total IU, Total ED.|24 months (prospective phase)||||||
1879|NCT02460458|Primary|Allergic Reactions During Use of VWF-containing Concentrates|Record of any allergic and anaphilactic reactions occurred in the past due to the use of any VWF concentrate and the date of onset.|24 months (retrospective)|||participants|||Number
1880|NCT02460458|Primary|Previous Use of Blood Products|Record of any product used in the previous 24 months (collected type of blood products/VWF concentrate, year of first exposure, units used).|24 months (retrospective)|||participants|||Number
1881|NCT02460458|Primary|Molecular Diagnosis of VWF in DNA|Evaluation of the presence of VWF gene defects (confirmation or screening for the first time).|36 months (retrospective + confirmatory phase)||||||
1882|NCT02460458|Primary|Test for Anti-VWF Antibodies|Evaluation of the titre of Anti-VWF Antibodies through Bethesda test (BU).|36 months (retrospective + confirmatory phase)||||||
1883|NCT02460458|Primary|General Laboratory Tests for VWD3 Diagnosis (Composite)|Hemoglobin: (mmol/L), HT(%), MVC (fl); Leucocytes: (E9/L); Neutrophil (%); Basophil (%); Eosinophil (%); Lymphocyte (%); Platelet count: (E9/L), MPV (fl); Prothrombin Time (sec); PTT (sec); PTT mix 50:50 (sec); Ferritin (ug/l); Bleeding Time (min:sec); Closure Time (Sec); Collagen/ADP (sec); Collagen/Epinephrine (sec); FVIII:C (IU/mL); VWF:RCo (IU/mL); VWF:Ag (IU/mL).|36 months (retrospective + confirmatory phase)||||||
1884|NCT02460458|Primary|Bleeding Severity Score (BSS)|The range of measurement is from -1 to +4 for each symptom considered (12 symptoms, total range from -12 to 48). For each symptom: 0=no symptom, 1=referred by the patient, 2=brought to medical attention, 3=major intervention. For spontaneous hemorrhagic symptoms, scores equal or greater than two require that the patient has specifically addressed that hemorrhagic symptom with a physician, whatever has been the diagnosis and therapy subsequently proposed. Score 0 and 1 are attributed to symptoms referred by the patient, hence without any precise medical intervention. Score 0 is for negligible or absent symptoms; 1 otherwise. For surgical procedures, it is considered important to differentiate between patients that have never bled because they never underwent surgery and those that did not bled after a surgery. These latter receive a negative score, indicating that the probability of VWD diminishes if you don’t bleed after surgery.|24 months (retrospective phase)|||Score on a scale||Full Range|Median
1885|NCT02458768|Primary|Number of Retrieved Oocytes||36 hrs (±3 hrs) after administration of the ovulation stimulant|Per-Protocol Set||Oocytes||Standard Deviation|Mean
1886|NCT02458365|Other Pre-specified|Number of Participants Experiencing Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment experienced during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
1887|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment perpetrated during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
1888|NCT02458365|Other Pre-specified|Number of Participants Experiencing Physical Peer Violence During Follow-up|"See above. Cronbach's Alphas for the three victimization scales were .89 for emotional mistreatment, .89 for physical violence, and .93 for sexual coercion. One or more incidents of physical peer violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
1889|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Physical Peer Violence During Follow-up|"Among participants not exposed to risk for dating violence, an 18-item measure assessed three types of peer violence perpetration and victimization (Levesque, 2007). Alphas for the three 3-item perpetrator scales are: .89 for emotional mistreatment, .89 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed peer violence experienced and perpetrated since January 1, 2010. Given the hierarchical structure of the perpetration measure, the physical violence and sexual coercion scales were combined to represent physical perpetration. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents coded as no."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.||participants|||Number
1890|NCT02458365|Secondary|Number of Participants Experiencing Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
1891|NCT02458365|Secondary|Number of Participants Perpetrating Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence perpetration during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
1892|NCT02458365|Secondary|Number of Participants Experiencing Physical Dating Violence During Follow-up|"See above. Cronbach's Alphas for the five victimization scales were .87 for emotional mistreatment, .86 for controlling behavior, .83 for threats, .76 for physical violence, and .90 for sexual coercion. One or more incidents of physical dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
1893|NCT02458365|Primary|Number of Participants Perpetrating Physical Dating Violence During Follow-up|"A 30-item measure assessing five types of dating violence perpetration and victimization was developed to meet specific needs of this research (Levesque, 2007). Alphas for the five 3-item perpetrator scales are: .88 for emotional mistreatment, .87 for controlling behavior, .91 for threats, .92 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed dating violence perpetrated and experienced since January 1, 2010. Given the hierarchical structure of the perpetration measure, the emotional mistreatment and controlling behavior scales were combined to represent emotional dating violence perpetration, and the threats, physical violence, and sexual coercion scales were combined to represent physical perpetration. Given extreme non-normal distributions, the two measures were then dichotomized. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents as no."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.||participants|||Number
5383|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
1894|NCT02457728|Primary|Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.|Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.|During hospitalization and 6 weeks after surgery.|||participants|||Number
1895|NCT02457247|Secondary|Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 28|The Safety Analysis Set included all randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
1896|NCT02457247|Secondary|Product Acceptability After Each 14 Day Dosing Period Within Each Test Group|Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect.|Day 14 and Day 28|The FAS included all randomized participants.||mm||Standard Error|Least Squares Mean
1897|NCT02457247|Primary|Percentage of Participants With a Preference for Each Treatment Within Each Test Group|Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D.|Day 28|All randomized participants from the Full Analysis Set (FAS) who received at least 1 dose of study medication and responded to the preference questionnaire.||percentage of participants|||Number
1898|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
1899|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||score on a scale||Standard Deviation|Mean
1900|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 2|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||seconds||Standard Deviation|Mean
1901|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 1|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||seconds||Standard Deviation|Mean
1902|NCT02455050|Secondary|Distance Visual Acuity in Period 2|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||Letters Read Correctly||Standard Deviation|Mean
1903|NCT02455050|Secondary|Distance Visual Acuity in Period 1|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||Letters Read Correctly||Standard Deviation|Mean
2089|NCT02442310|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest||Hour||Standard Deviation|Mean
1904|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 6 participants.||percentage of participants|||Number
1905|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 3 participants.||percentage of participants|||Number
1906|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
1907|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||score on a scale||Standard Deviation|Mean
1908|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||percentage of participants|||Number
1909|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||percentage of participants|||Number
1910|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
1911|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.||score on a scale||Standard Deviation|Mean
1951|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-II|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-II will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||percent of dose||Standard Deviation|Mean
2122|NCT02439138|Secondary|Percentage of Participants With Adverse Events|Assess the safety and tolerability of idelalisib|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with AEs|||Number
1912|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.||score on a scale||Standard Deviation|Mean
1913|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Participants enrolled in Period 1.||score on a scale||Standard Deviation|Mean
1914|NCT02454608|Other Pre-specified|Diastolic Blood Pressure||Mean change between baseline and week 8 measurements|||mmHg||Standard Deviation|Mean
1915|NCT02454608|Other Pre-specified|Systolic Blood Pressure||Mean change between baseline and week 8 measurements|||mmHg||Standard Deviation|Mean
1916|NCT02454608|Other Pre-specified|Heart Rate||Mean change between baseline and week 8 measurements.|||beats per minute||Standard Deviation|Mean
1917|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-McKay Score(LMS)|Minimum Score: 0 Maximum Score: 24 Higher value represents worse outcome.|Week 8|Intention-to-treat analysis||units on a scale||Standard Deviation|Mean
1918|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-Kennedy Score(LKS)|Minimum Score: 0 Maximum Score: 12 Higher value represents worse outcome.|baseline to week 8|Intention-to-treat analysis||units on a scale||Standard Error|Least Squares Mean
1919|NCT02454608|Primary|Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)|Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.|baseline to week 8|Intention-to-treat analysis||units on a scale||Standard Error|Least Squares Mean
1920|NCT02454608|Primary|Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)|Minimun Score: 0 Maximum Score: 110 A higher score indicates a worse outcome|baseline to week 8|Intention-to-treat analysis||units on a scale||Standard Error|Least Squares Mean
1921|NCT02454283|Secondary|Length of Stay (From Time of Study Drug Administration)||8 days|||days||Standard Deviation|Mean
1922|NCT02454283|Primary|Conversion to Sinus Rhythm|Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.|24 hours|||participants|||Number
1923|NCT02454127|Secondary|C-reactive Protein|Change from baseline high-sensitivity CRP at 1 year, measured in mg/L|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||mg/L||Standard Deviation|Mean
1924|NCT02454127|Secondary|Insulin|Change from baseline insulin at 1 year, measured in microIU/mL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values||microIU/ml||Standard Deviation|Mean
1925|NCT02454127|Secondary|Glucose|Change from baseline glucose at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||mg/dL||Standard Deviation|Mean
1926|NCT02454127|Secondary|Triglycerides|Change from baseline triglycerides at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values||mg/dL||Standard Deviation|Mean
1927|NCT02454127|Secondary|HDL Cholesterol|Change from baseline HDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||mg/dL||Standard Deviation|Mean
1928|NCT02454127|Secondary|LDL Cholesterol|Change from baseline LDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values||mg/dL||Standard Deviation|Mean
1929|NCT02454127|Secondary|Total Cholesterol|Change in total cholesterol from baseline at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline data.||mg/dL||Standard Deviation|Mean
1930|NCT02454127|Primary|Weight Loss|Change from baseline body weight at 1 year, measured in kilograms|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.||kg||Standard Deviation|Mean
1931|NCT02454101|Secondary|Duration of Third Stage of Labor|number of minutes from delivery of the baby till delivery of the placenta|immediatly after delivery|||minutes||Standard Deviation|Mean
1932|NCT02454101|Secondary|Maternal Additional Need for Therapeutic Uterotonics|number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery|1st 24 hours of delivery|||participants|||Number
1933|NCT02454101|Secondary|Maternal Need for Blood Transfusion.|number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion|1st 24 hours after delivery|||participants|||Number
1952|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-I|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-I will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||percent of dose||Standard Deviation|Mean
1934|NCT02454101|Secondary|Neonatal Apgar Score (After 5 Minutes of Delivery).|"The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's:~Breathing effort~Heart rate~Muscle tone~Reflexes~Skin color~Each category is scored with 0, 1, or 2, depending on the observed condition.~The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.~A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.~Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs"|5 minutes of delivery|Number of Infants Analyzed||Scores on a Scale from 1 to 10||Standard Deviation|Mean
1935|NCT02454101|Secondary|Neonatal Intensive Care Unit (NICU) Admission|number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery|1st 24 hours after delivery|Number of Infants Analyzed||participants|||Number
1936|NCT02454101|Secondary|Neonatal Intubation|number of newborns requirng intubation in the first 2 hours after delivery|1st 2 hours after delivery|Number of Infants Analyzed||participants|||Number
1937|NCT02454101|Secondary|Severe Postpartum Haemorrage|(measured blood loss 1000 mL or more|24 hours after labor|||participants|||Number
1938|NCT02454101|Secondary|Jundice Requring Phtotherapy|number of infants requiring phtotherapy for jundice in the first 2 weeks|two weks|Number of Infants Analyzed||participants|||Number
1939|NCT02454101|Primary|Neonatal Hemoglobin Level|neonatal 6 weeks hemoglobin measured in gram %|6 weeks after labor|Number of Infants Analyzed||gram%||Standard Deviation|Mean
1940|NCT02453581|Primary|500mg Cohort Mean Parasite Reduction Ratio (PRR)|OZ439 500mg individual subject PRR and corresponding 95% CI were used to calculate the OZ439 500mg cohort specific PRR and the corresponding 95% CI: the weighted average slope estimate and corresponding SE were calculated by the inverse-variance method.|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3. With a p value of 0.0046, Subject S036 was excluded from this calculation||none (ratio)||95% Confidence Interval|Mean
1941|NCT02453581|Secondary|OZ439 AUC(0-144)|OZ439 Area under the curve to 144 hours|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1942|NCT02453581|Secondary|OZ439 Cmax|OZ439 Maximum concentration (Cmax)|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1943|NCT02453581|Primary|Individual Parasite Reduction Ratio (PRR)|"PRR estimates the efficacy of an anti-malarial treatment and is the ratio of the parasite density between admission and 48 hours post-treatment.~Individual subject PRR and corresponding 95% CI were calculated using the slope and corresponding standard error of mean (SE) of the optimal regression model."|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3.||none (ratio)||95% Confidence Interval|Number
1944|NCT02452944|Secondary|Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease|We checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.|up to 8 weeks|||participants|||Number
1945|NCT02452944|Primary|Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group|"We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients.~In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a ‘fail’."|up to 8 weeks|||participants|||Number
1946|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Laboratory Test Results|Laboratory test results are defined as serum chemistry, hematology and urinalysis.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
1947|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Resting 12-Lead Electrocardiogram (ECG)|A resting 12-lead ECG was recorded. The investigator or subinvestigator (or a qualified physician at the study site) interpreted the ECG results.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
1948|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Body Weight||Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
1949|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Vital Signs|Vital signs are defined as sitting blood pressure, sitting pulse rate and temperature.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.||percentage of participants|||Number
1950|NCT02451150|Primary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Up to 15 Days|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
1982|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)||Baseline to 15 days post-treatment|||Percentage of Parabasal Cells||Standard Error|Least Squares Mean
1953|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan)|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||percent of dose||Standard Deviation|Mean
1954|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-II|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Standard Deviation|Mean
1955|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-II|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Full Range|Median
1956|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
1957|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-II|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
1958|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
1959|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-I|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Standard Deviation|Mean
1960|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-I|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Full Range|Median
1961|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
1962|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-I|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
1963|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
1964|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan)|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Standard Deviation|Mean
1965|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||hours||Full Range|Median
1966|NCT02451150|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
1967|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
1968|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
1969|NCT02450799|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit|Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.|Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)|This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).||logMAR||Standard Deviation|Mean
1970|NCT02450747|Primary|Average Corneal Staining Area Grade|Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.|Baseline to 4- Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Average Percentage of Staining|Subject Eyes|Standard Deviation|Mean
1971|NCT02450747|Primary|Upper Lid Margin Staining Score|Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||percentage of eyes|Subject Eyes||Number
1972|NCT02450747|Primary|The Total Grade of Conjunctival Hyperemia|Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis is conducted on subject eyes.||units on a scale|Subject Eyes|Standard Deviation|Mean
1973|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Secretions)|Outcome was measured by using a severity scale. No Atrophy has normal clear secretions noted on vaginal walls(0). Mild atrophy has superficial coating of secretions, difficulty with speculum insertion(1). Moderate atrophy is scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain(2). Severe atrophy has none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
1974|NCT02449902|Primary|Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Surface Thickness)|Outcome was measured by using a severity scale. No Atrophy has rogation and elasticity of vault(0). Mild atrophy has poor rogation with some elasticity noted of vaginal vault(1). Moderate atrophy is smooth, some elasticity of vaginal vault(2). Severe atrophy is smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
1975|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Integrity)|Outcome was measured by using a severity scale. No Atrophy=normal(0). Mild atrophy=vaginal surface bleeds with scraping(1). Moderate atrophy=vaginal surface bleeds with light contact(2). Severe atrophy=vaginal surface has petechiae before contact and bleeds with light contact(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
1976|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Color)|Outcome was measured by using a severity scale. No Atrophy is pink in color (0). Mild atrophy is lighter in color (1). Moderate atrophy is pale in color (2). Severe atrophy is transparent, either no color or inflamed (3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.||units on a scale||Standard Error|Least Squares Mean
1977|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.|Baseline to 15 days post-treatment|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.||participants|||Number
1978|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Severity of the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom|The severity of the most bothersome VVA symptom was self-assessed by each subject using a VVA questionnaire. The questionnaire has a 4-point scoring scale with: None=0, Mild=1, Moderate=2, and Severe=3. The lower the score, the least bothersome it is to the subject.|Baseline to 15 days post-treatment|||units on a scale||Standard Error|Least Squares Mean
1979|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal pH||Baseline to 15 days post-treatment|||pH||Standard Error|Least Squares Mean
1980|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Intermediate Cells)||Baseline to 15 days post-treatment|||Percentage of Intermediate Cells||Standard Error|Least Squares Mean
1981|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Superficial Cells)||Baseline to 15 days post-treatment|||Percentage of Superficial Cells||Standard Error|Least Squares Mean
1983|NCT02449044|Secondary|Change From Baseline in the Hyponatremia Disease-specific Survey|Analysis of individual items of Hyponatremia Disease-specific Survey was not conducted, because the analysis of Hyponatremia Disease-specific Survey was focused on the PCS and MCS summary scores since these 2 scores were developed. Subgroup analyses of Hyponatremia Disease-specific Survey were also not conducted.|Baseline to Week 214|The Hyponatremia Disease-specific Survey PCS and MCS scores evaluated during the trial were variable with only nominal changes from baseline observed. The data were collected under 2 different datasets, so the number of participants in each dataset was reduced that limited analysis of this endpoint.|||||
1984|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS)|The MCS assess the physical and mental dimensions of health-related quality of life. The MCS is equal to the sum of the items of concentration activities, calculating activities, language activities, and memory activities. The MCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale’s publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||Units on a scale||Standard Deviation|Mean
1985|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS)|The PCS assess the physical and mental dimensions of health-related quality of life. The PCS is equal to the sum of the items of endurance activities, strength activities, gross coordination activities, and fine coordination activities. The PCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale’s publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||Units on a scale||Standard Deviation|Mean
1986|NCT02449044|Secondary|Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline|Body weight at each visit (assessed only for those with clinical evidence of hypervolemia at Baseline) and was summarized using descriptive statistics.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. The observed cases (OC) dataset consisted of only data points obtained from participants who were evaluated at the visit, without missing study drug consecutively for 14 days.||kg||Standard Deviation|Mean
1987|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Other Medicines|Percentage of participants requiring prescription of other medicines for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring other medicines such as demeclocycline or urea was not analyzed.||percentage of participants|||Number
1988|NCT02449044|Secondary|Number of Participants Requiring Prescription of Hypertonic Saline|Percentage of participants requiring prescription of hypertonic saline for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring prescription of hypertonic saline was not analyzed due to a low number of participants who received the treatment.||participants|||Number
1989|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Fluid Restriction|Percentage of participants requiring prescription of fluid restriction for the express purpose of treating hyponatremia during each period of the trial. Assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
1990|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Normal Sodium Levels|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
1991|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Mild Hyponatremia|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
2001|NCT02448914|Secondary|Number of Adverse Events||Patients will be followed for the duration of the hospital stay, an expected average of 3 days|||adverse events|||Number
2002|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for Carbidopa||During 14 h infusion on 2 consecutive days|||h*ng/mL/mg||Full Range|Least Squares Mean
3824|NCT02297308|Secondary|Bleeding Complications at the Access Site|VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding|within 30 days of TAVI procedure|||participants|||Number
1992|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Severe Hyponatremia|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||percentage of participants|||Number
1993|NCT02449044|Secondary|Mean Change From Baseline in Serum Sodium Measurements|Sodium measurements obtained at designated intervals were compared to each participant's Baseline sodium level at the beginning of placebo-controlled therapy in their original trial and from Baseline on initiation of therapy in the open-label trial.|Baseline of parent trial to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.||mEq/L||Standard Deviation|Mean
1994|NCT02449044|Primary|Participants With Body Weight Abnormalities Reported as TEAEs|The body weight evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Every effort was made to ensure that body weight measurements were performed in a reproducible and consistent manner. The pre-defined criteria was change of ≥7% in body weight for both male and female. Participants were to wear the same type of clothes at each measurement, preferably a gown and no shoes. All body weight measurements were to have been taken post-void.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
1995|NCT02449044|Primary|Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Criteria for identifying vital signs of potential clinical relevance included: Heart rate, supine: >= 120 beats per minute (bpm) + increase of ≥15 bpm from Baseline and <=50 bpm + decrease of >= 15 bpm; Diastolic Blood Pressure, Supine: >=105 mmHg + increase of >=15 mmHg and <=50 mmHg + decrease of >=15 mmHg; Systolic Blood Pressure, Supine: >=180 mmHg + increase of >=20 mmHg and <= 90 mmHg + decrease of >=20 mmHg; Temperature (degree C): Increase of >=1.1 to >=38.3C. The vital sign abnormalities were reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The intent-to-treat (ITT) dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
1996|NCT02449044|Primary|Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs|The ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in HR outliers, PR outliers, QRS outliers, QT, QTcB, QTcF that were identified based on pre-defined criteria. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: For QTcB and QTcF: baseline mean of QTcB and QTcF interval was new onset >500 msec, 30 - 60 msec, >60 msec; For QT: new onset >500 msec; For QRS outliers: >=25% change from baseline when QRS >100 msec; PR outliers: >=25% change from baseline when PR>200 msec; HR outliers: 25% decrease from baseline and HR <50 bpm or 25% increase from baseline and HR >100 bpm. New onset (>500 msec) in QT, QTcB, or QTcF means a participant who attained a value >500 msec during treatment period but not at each baseline visit. The ECG-related abnormalities are reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
1997|NCT02449044|Primary|Participants With Laboratory Values Abnormalities Reported as TEAEs|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant for identifying laboratory values of potential clinical relevance. Participants noted with abnormal laboratory values are reported below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
1998|NCT02449044|Primary|Participants With Adverse Events (AEs)|A TEAE was an AE that began after the first injection or was continuous from Baseline and was defined as any new medical problem, or exacerbation of an existing problem, whether or not it was considered drug-related by the study physician. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-subject hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent the outcomes mentioned above.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.||participants|||Number
1999|NCT02448914|Other Pre-specified|Treatment Response Scale (ON/OFF Effect) - Mean % of Time Patients Were in Functional ON State During 3-14 h|Dyskinesia and parkinsonism symptoms were evaluated throughout the study period as an assessment of the clinical response. To assess the ON/OFF effect the Treatment Response Scale (TRS) was used. The TRS ranges from -3 (severe “OFF”) to +3 (“ON” with severe dyskinesia). Results from the TRS recordings are presented as the mean percentage of time patients were in functional ON state (TRS: -1 to +1) during the time interval 3-14 h.|TRS assessments were made every 30 minutes from start of study drug administration until 3 h, every hour between 3 and 14 h and every 30 minutes between 14 and 17 h.|||Mean % of time||Full Range|Mean
2000|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for 3-O-Methyldopa||During 14 h infusion on 2 consecutive days|||h*ng/mL/mg||Full Range|Least Squares Mean
8446|NCT02093702|Primary|Mean Change in Body Mass Index||Baseline and 12 months|||kg/m^2||Full Range|Mean
2003|NCT02448914|Secondary|Intra-individual Coefficient of Variation (3-14h) for Levodopa|The individual patient’s coefficient of variation (CV) of levodopa plasma concentration during administration of TRIGEL and Duodopa respectively between 3 and 14 h after start of study drug. CV=100*sqrt (exp (SDlog*SDlog)-1) were SDlog denotes the standard deviation computed on logged plasma concentrations.|During 3-14h infusion on 2 consecutive days|||percentage of variability||Full Range|Least Squares Mean
2004|NCT02448914|Primary|Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa||During 14 h infusion on 2 consecutive days|||h*ng/mL/mg||Full Range|Least Squares Mean
2005|NCT02448862|Secondary|Incidence of Dizziness or Headaches|The percentage of participants who had headache and dizziness|Postoperative 48 hours|||percentage of participants|||Number
2006|NCT02448862|Secondary|Incidence of Nausea and Vomiting|The percentage of participants who had nausea and vomiting during postoperative 48 hours|Postoperative 48 hours|||percentage of participants|||Number
2007|NCT02448862|Secondary|Postoperative Pain in Numeric Pain Scale|The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0~6, 6~12, 12~18, 18~24, 24~48 hours)|Postoperative 48 hours|||Scores on a scale||Standard Deviation|Mean
2008|NCT02448862|Primary|Incidence of Rescue Antiemetics Requirement|The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period|Postoperative 48 hours|||Percentage of Participants|||Number
2009|NCT02448862|Primary|Incidence of Rescue Analgesics Requirement|The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period|Postoperative 48 hours|||Percentage of Participants|||Number
2010|NCT02447458|Secondary|Renal Clearance (CLr) of MLN3126 and Metabolite M-I|Renal clearance was calculated as CLr=Ae(0-96)/AUC (0-96).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.||mL/min||Standard Deviation|Mean
2011|NCT02447458|Secondary|Fe: Fraction of MLN3126 Excreted in the Urine|Fe is the Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.||Percentage||Standard Deviation|Mean
2012|NCT02447458|Secondary|Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine|Ae (0-96) is the total amount of drug excreted in urine from time 0 to time 96 hours.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.||ng||Standard Deviation|Mean
2013|NCT02447458|Secondary|T ½: Half-life of MLN3126 and Metabolite M-I|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||Hours||Standard Deviation|Mean
2014|NCT02447458|Secondary|CL/F: Oral Clearance of MLN3126|CL/F is apparent clearance of the drug from the plasma, after extravascular administration.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||L/hr||Standard Deviation|Mean
2015|NCT02447458|Secondary|AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity|AUC(0-inf) is measure of area under the curve from time 0 to infinity.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2016|NCT02447458|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2017|NCT02447458|Secondary|Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Tmax is the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||Hours||Full Range|Median
2018|NCT02447458|Secondary|Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|Pharmacokinetic (PK) analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.||ng/mL||Standard Deviation|Mean
2019|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
2020|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose|Vital signs included oral body temperature measurement, blood pressure, respiration rate, and pulse rate [beats per minute (bpm) or heart rate]. The percentage of participant with markedly abnormal vital signs findings during the study. OBP=Orthostatic Blood Pressure. All OBP measurements were standing.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
2021|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose|Clinical safety laboratory tests included clinical chemistry, hematology and urinalysis. The percentage of participants with any markedly abnormal laboratory finding during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
2090|NCT02442310|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest||μg/mL||Standard Deviation|Mean
2022|NCT02447458|Primary|Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 22|Safety population included all enrolled participants who received at least 1 dose of study drug.||Participants|||Number
2023|NCT02447133|Primary|TopQ Cut Off|To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.|1 hour|use of 12 subjects for 3 different scan patterns||microns|||Number
2024|NCT02446990|Secondary|Secondary Composite Endpoint|Non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2025|NCT02446990|Secondary|Secondary Composite Endpoint|Coronary death, non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2026|NCT02446990|Secondary|Secondary Composite Endpoint|Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2027|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2028|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2029|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2030|NCT02446990|Secondary|Coronary Revascularisation (Elective or Not)|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2031|NCT02446990|Secondary|Elective Coronary Revascularisation|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2032|NCT02446990|Secondary|Non-fatal Myocardial Infarction|Component of the primary composite endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months|||participants|||Number
2033|NCT02446990|Secondary|Fatal Myocardial Infarction|Non-composite secondary endpoint|From the date of randomisation to death, up to 48 months|||participants|||Number
2034|NCT02446990|Secondary|Coronary Mortality|Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death|From the date of randomisation to death, up to 48 months|||participants|||Number
2035|NCT02446990|Secondary|Cardiovascular Mortality|Component of the primary composite endpoint|From the date of randomisation to death, up to 48 months|||participants|||Number
2036|NCT02446990|Secondary|All-cause Mortality||From the date of randomisation to death, up to 48 months|||participants|||Number
2037|NCT02446990|Primary|Primary Composite Endpoint|First event among cardiovascular death or non-fatal myocardial infarction|The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.|||participants|||Number
2038|NCT02446171|Secondary|Taste Test Assessment.|A standardized questionnaire was provided to participants and were asked to complete the questionnaire for the liquid formulations tested, i.e., Naloxegol crushed tablet, oral (Treatment A) and Naloxegol oral solution (Treatment C), without assistance or influence from site personnel. For each formulation, the questionnaire was identical and required the participant's opinion. Sweet, salty, sour, bitter, metallic, hot/spicy were rated on a scale of 0 to 10, where 0 means not at all and 10 means extreme. The overall rating of the taste was rated on a scale of 0 to 10, where 0 means “I dislike it extremely much” and 10 means “I like it extremely much”. The smell of the medicine was based on a scale of 0 to 10, where 0 means extremely bad and 10 means extremely nice. The question on whether the participants would consider ever taking the medicine again was based on a scale of 0 to 10, where 0 means “Never – under no circumstances” and 10 means “Yes, definitely”.|Within 1 hour after dosing (Treatments A and C only).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||units on a scale||Full Range|Median
2039|NCT02446171|Secondary|Participants With Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening and at the final follow-up visit (maximum 9 weeks apart); in addition, for the first and third treatment period at pre-dose.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
2040|NCT02446171|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening, first admission to the clinical unit (Visit 2, Day -1), 1.25 hours after each dose (Visits 2-5, Day 1), as well as at the final follow-up visit (up to 9 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
8447|NCT02093702|Primary|Mean Change in Waist Circumference||Baseline and 12 months|||cm||Full Range|Mean
2041|NCT02446171|Secondary|Participants With Significant Findings in Columbia-Suicide Severity Rating Scale (C-SSRS).|The C-SSRS is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events, and provided a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation and deterrents), all of which are significantly predictive of completed suicide. The C-SSRS was performed to determine the presence of suicidality.|At Baseline and Days 1-4 of each treatment period.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
2042|NCT02446171|Secondary|Participants With Significant Findings in Physical Examination.|A complete physical examination included an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, mouth and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. Physical examination was performed to check for any significant abnormality in participants.|A full physical examination at screening and the final follow-up visit (maximum 9 weeks apart). Abbreviated physical examination on admission (on Day -1 of each treatment period) and at 48-hours post-dose to each treatment period (for up to 4 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||participants|||Number
2043|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Pulse rate: the measurement of vital signs for pulse rate is presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||beats per minute (bpm)||Standard Deviation|Mean
2044|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs of Supine Systolic and Diastolic Blood Pressure.|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: Systolic Blood Pressure (SBP) and Diastolic BP. The measurement of vital signs for SBP and DBP are presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||mmHg||Standard Deviation|Mean
2045|NCT02446171|Secondary|Percentage of Participants With Adverse Events (AE).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.The term AE is used generally to include any AE whether serious or non-serious. An serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|For up to 9 weeks (starting with screening).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.||percentage of participants|||Number
2046|NCT02446171|Secondary|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F).|This was one of the PK parameters to determine the apparent volume of distribution during the terminal phase after extravascular administration.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||L||Geometric Coefficient of Variation|Geometric Mean
2047|NCT02446171|Secondary|Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F).|This was one of the PK parameters to determine the apparent total body clearance after extravascular administration estimated as dose divided by AUC. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||L/h||Geometric Coefficient of Variation|Geometric Mean
2048|NCT02446171|Secondary|Mean Residence Time (MRT).|This was one of the PK parameters to determine MRT. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h||Standard Deviation|Mean
2049|NCT02446171|Secondary|Mean Dissolution Time (MDT).|This was one of the PK parameters to determine MDT (whole tablet only) (calculated as MRT Treatment D [Reference] - MRT Treatment C [Test]). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point. There were zero participants analyzed in Treatment A, B and C, hence data was not determined.||h||Standard Deviation|Mean
2091|NCT02441218|Secondary|Secondary Composite Endpoint|CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction|From the date of randomisation to the date of the first event, up to 42 months|||participants|||Number
2050|NCT02446171|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz).|This was one of the PK parameters to determine λz of a t½λz. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h||Standard Deviation|Mean
2051|NCT02446171|Secondary|Time to Reach Maximum Plasma Concentration (Tmax).|This was one of the PK parameters to determine the time to reach maximum plasma concentration (tmax). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h||Full Range|Median
2052|NCT02446171|Primary|Observed Maximum Plasma Concentration (Cmax).|Observed maximum plasma concentration (Cmax) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2053|NCT02446171|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC 0-t).|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2054|NCT02446171|Primary|Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-infinity).|Area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to administration of the investigational medicinal product (IMP)]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The Pharmacokinetic (PK) analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2055|NCT02445755|Primary|In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.||12 to 48 hours|||mg/dL||Standard Deviation|Mean
2056|NCT02445573|Other Pre-specified|Adverse Events|Number of participants who experienced Adverse Events was collected.|weeks 1-30|||participants|||Number
2057|NCT02445573|Secondary|Patient Self-evaluation of Therapeutic Effect|"Participants were asked to rate the extent of help that they received from treatment as no help, little help. moderate help or great help.~Number of participants reporting different extent of help was collected."|weeks 6, 18 and 30|||participants|||Number
2058|NCT02445573|Secondary|Change From Baseline of the Total ICIQ-SF Scores|The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.It was used to assess the influence of urinary incontinence on quality of life during the past 4 weeks retrospectively. It contained three items on frequency, amount of leakage, and overall impact on quality of life, and a fourth, non-scored item for the assessment of type of incontinence. A total score was summed by the scores of the first three items, ranging from 0 to 21. A higher value indicates increased severity.|Baseline, and weeks 6, 18 and 30|||units on a scale||Standard Error|Mean
2059|NCT02445573|Secondary|Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)|"Data of IEF was from 72-hour bladder diary recorded by participants over the last 72 hours of weeks 0 (baseline), weeks 2, 4, 6 (treatment period) and weeks 15-18,and 27-30 (follow-up period).~The 72-hour IEF of weeks 1-6 equaled the sum of 72h IEF at weeks 2, 4 and 6 divided by 3; The 72-hour IEF of weeks 15-18 equaled the sum of 72h IEF at weeks 15-18 divided by 4; The 72-hour IEF of weeks 27-30 equaled the sum of 72h IEF at weeks 27-30 divided by 4."|Baseline, weeks 1-6, weeks 15-18 and weeks 27-30|||episodes||Inter-Quartile Range|Median
2060|NCT02445573|Primary|Change From Baseline of Urine Leakage Measured by 1-hour Pad Test||Baseline and week 6|||g||Inter-Quartile Range|Median
2069|NCT02444715|Secondary|Change in Whole Grain Food Consumption|"Self-reported weekly portions of whole grain food consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of whole grain food and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on whole grain food consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||portions||Inter-Quartile Range|Median
2092|NCT02441218|Secondary|Unplanned Hospitalisation for CV Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months.|||participants|||Number
2093|NCT02441218|Secondary|Unplanned Hospitalisation for Any Cause||From the date of randomisation to the first documented hospitalisation, up to 42 months|||participants|||Number
2061|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images SND|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-SND arm above.||units on a scale|images|Standard Error|Mean
2062|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-FDK arm above.||units on a scale|images|Standard Error|Mean
2063|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-High Resolution arm above.||units on a scale|images|Standard Error|Mean
2064|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 2D Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 total image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for each of the above two arms.||units on a scale|images|Standard Error|Mean
2065|NCT02444715|Other Pre-specified|Usability: SUS Score|"The usability of the intervention was assessed based on the standardised System Usability Scale (SUS).~SUS scores were not collected in the SC group because the SC participants were not using CAPSYS and hence were not able to assess its usability.~The System Usability Scale (SUS) provides a “quick and dirty”, reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.~The total SUS score computed based on the responses provided to each of the 10 items can range from 0 (worst) to 100 (best). Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average."|6 months|SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires.||units on a scale (total SUS score)||Standard Deviation|Mean
2066|NCT02444715|Secondary|Change in Quality of Life|"The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group.~In this context, the health value was specified by the participants on a subjective scale ranging from 0 (The worst health you can imagine) to 100 (The best health you can imagine)."|baseline and 6 months|Data on quality of life was retrieved from final questionnaires. Hence, QoL data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||units on a scale (health value)||Inter-Quartile Range|Median
2067|NCT02444715|Secondary|Change in Duration of Physical Activity|Self-reported weekly duration of physical activity of medium or high intensity|baseline and 6 months|Data on physical activity was retrieved from final questionnaires. Hence, physical activity data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||minutes||Inter-Quartile Range|Median
2068|NCT02444715|Secondary|Change in Sweets Consumption|"Self-reported weekly portions of sweets consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of sweets and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on sweets consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||portions||Inter-Quartile Range|Median
2094|NCT02441218|Secondary|Hospitalisation for Cardiovascular Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months|||participants|||Number
2070|NCT02444715|Secondary|Change in Fruits and Vegetables Consumption|"Self-reported weekly portions of fruits and vegetables consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of fruits or vegetables and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on fruits and vegetables consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.||portions||Inter-Quartile Range|Median
2071|NCT02444715|Primary|Change in BMI Value||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Weight data is missing for 9 of the 46 SC and 15 of the 48 IC participants who started the study.||kg/m^2||Standard Deviation|Mean
2072|NCT02444715|Primary|Change in Glycaemia Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Glycaemia data is missing for 6 of the 46 SC and 13 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
2073|NCT02444715|Primary|Change in HbA1c Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HbA1c data is missing for 21 of the 46 SC and 21 of the 48 IC participants who started the study.||percent HbA1c||Inter-Quartile Range|Median
2074|NCT02444715|Primary|Change in Triglyceride Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Triglyceride data is missing for 16 of the 46 SC and 16 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
2075|NCT02444715|Primary|Change in LDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. LDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
2076|NCT02444715|Primary|Change in HDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.||mg/dl||Inter-Quartile Range|Median
2077|NCT02444715|Primary|Change in Systolic Blood Pressure||baseline and 6 months|Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.||mmHg||Standard Deviation|Mean
2078|NCT02444182|Primary|Plaque Index|"A modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque~= separate flecks of plaque at the cervical margin of the tooth~= a thin continuous band of plaque at the cervical margin~= a band of plaque wider than 1 mm but covering less than 1/3 of the crown~= plaque covering at least 1/3 but less than 2/3 of the crown~= plaque covering 2/3 or more of crown~An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined.~** Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)"|four weeks|||units on a scale||Standard Deviation|Mean
2079|NCT02444182|Primary|Gingival Health|"The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered.~The criteria are:~0 = no inflammation~= mild inflammation, slight change in color, slight edema, no bleeding on probing~= moderate inflammation, moderate glazing, redness, bleeding on probing~= severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding~The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four.~The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined~A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation"|Four weeks|||units on a scale||Standard Deviation|Mean
2080|NCT02443792|Secondary|Infection|Proportion experiencing post-op infection, determined clinically (treated with antibiotics)|Up to 4 weeks|||participants|||Number
2081|NCT02443792|Secondary|Wound Dehiscence|Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)|Up to 4 weeks|||participants|||Number
2082|NCT02443792|Secondary|Completely Healed at 4 Weeks|Number of participants who were completely healed at 4 weeks|At the 4-week followup visit|||participants|||Number
2083|NCT02443792|Secondary|Surgical Pain 0=no Pain; 10=Worst Pain Ever|Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever|Up to 30 minutes|||units on a scale||Standard Deviation|Mean
2084|NCT02443792|Primary|Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing|Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing|Up to 30 minutes|||Minutes||Inter-Quartile Range|Median
2085|NCT02442700|Secondary|Safety of Pitavastatin in HIV-infected Patients|"Safety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event.~Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo."|12 weeks|||U/L||95% Confidence Interval|Mean
2086|NCT02442700|Primary|Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir|Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.|12 weeks|||mg/dL||95% Confidence Interval|Mean
2087|NCT02442310|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)|The safety population included all subjects who received at least one of the investigational products under study.||participants|||Number
2088|NCT02442310|Primary|AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest||ug*h/mL||Standard Deviation|Mean
2101|NCT02441179|Secondary|Learning and Memory With the Complutense Verbal Learning Test (TAVEC)|"The TAVEC is the Spanish version of the California Verbal Learning Test and is used for the assessment of episodic verbal memory.~Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.~Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic verbal memory at week 4.|"Analysis per protocol"||Z scores||Inter-Quartile Range|Median
2102|NCT02441179|Secondary|Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test|"The ROCF is a neuropsychological instrument used for assessment of episodic visual memory.~Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.~Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic visual memory at week 4.|"Analysis per protocol"||Z scores||Inter-Quartile Range|Median
2103|NCT02441179|Secondary|"Percentage of Subjects With Worsening Pain Perception on the The Visual Analog Test"|The visual analog test assess general pain intensity. It is a 10-score scale ranging from no pain (score 0) to unbearable pain (score 10).|Pain perception at week 4|"Analysis per protocol"||percentage of subjects|||Number
2104|NCT02441179|Secondary|Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale|The Ashworth Scale assess muscle tone. It is a 5-points scale ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension).|Muscle tone at week 4.|"Analysis per protocol"||percentage of subjects|||Number
2105|NCT02441179|Secondary|Gait Speed With the Timed up and go Test|The timed up and go test measures the time (in seconds) it takes the patient to stand-up from a seated position in a chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down.|Change from baseline in gait speed five days after daily IH.|"The analysis was per protocol"||seconds||Standard Error|Mean
2106|NCT02441179|Secondary|Gait Endurance With the 6-Minute Walk Test|The 6-Minute Walk Test measures the distance (in meters) a patient is able to walk over 6 minutes.|Change from baseline in gait indurance five days after daily IH.|"The analysis was per protocol"||meters||Standard Error|Mean
2107|NCT02441179|Primary|Gait Speed With 10-Meter Walk Test|The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.|Change from baseline in gait speed five days after daily IH.|"Analysis was per protocol"||seconds||Standard Error|Mean
2108|NCT02441114|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3||pg/mL||Standard Deviation|Mean
2109|NCT02441114|Secondary|Time to Maximum Concentration (Tmax)|Time to maximum concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3||h||Full Range|Median
2110|NCT02441114|Primary|Area Under the Concentration Versus Time Curve (AUClast)|Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3||h*pg/mL||Standard Deviation|Mean
2111|NCT02440659|Primary|Patient's Quality of Life|% of patients very much or extremely affected by dialysis|Baseline|||% of patients|||Number
2112|NCT02440633|Primary|AUC of OPS-2071 in Plasma|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.|||μg·h/L||Standard Deviation|Mean
2113|NCT02440633|Primary|Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.|||μg eq.·h/L||Standard Deviation|Mean
2114|NCT02440633|Primary|The Amounts of Radioactivity Excreted in Urine and Faeces|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.|up to144-168h postdose.|||percentage of administered dose||Standard Deviation|Mean
2115|NCT02439879|Primary|Total Symptoms Score|Total symptoms score is a summation of presence, severity, and duration of the four main positive neuropathic sensory symptoms: lancinating/stabbing pain, burning pain, paresthesia, and asleep numbness|20 weeks|||units on a scale||Standard Error|Mean
2116|NCT02439138|Secondary|Rate of Progressive Disease|Progressive disease measured by an 25% increase in serum IgM level with an absolute increase of at least 500mg/dL from the lowest attained IgM on therapy.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with PD|||Number
2117|NCT02439138|Secondary|Rate of Stable Disease|Stable disease measured by serum IgM levels <25% reduced from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with SD|||Number
2118|NCT02439138|Secondary|Rate of Minimal Response|Minimal response measured by decrease in serum IgM levels of between 25% and 50%.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with MR|||Number
2119|NCT02439138|Secondary|Rate of Partial Response (PR)|PR measured by decrease in serum IgM levels of between 25% and 50% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with PR|||Number
2120|NCT02439138|Secondary|Rate of Very Good Partial Response (VGPR)|VGPR measured by decrease in serum IgM levels of at least 90% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with VGPR|||Number
2121|NCT02439138|Secondary|Rate of Complete Response (CR)|CR measured by decrease in serum IgM levels to normal range, disappearnace of monoclonal protein by immunofixation, no evidence of bone marrow involvement, and resolution of any extramedullary disease by CT scan.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|||percentage of participants with CR|||Number
8448|NCT02093702|Primary|Mean Change in Systolic Blood Pressure||Baseline and 12 months|||mm Hg||Full Range|Mean
2123|NCT02439138|Primary|Overall Response Rate (ORR)|ORR measured by decrease in serum IgM level by at least 25% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|4 of 5 participants returned for at least 1 follow-up to assess disease response.||percentage of participants with response|||Number
2124|NCT02438540|Secondary|HOMA-IR|Changes of IR was calculated by the homeostasis model (HOMA-IR), proposed by Matthews et al. HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22•5. Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||units on a scale||Standard Deviation|Mean
2125|NCT02438540|Secondary|Body Mass Index (BMI)|change of BMI. Body height was measured to an accuracy of +/-0.1cm. BMI was calculated by dividing weight (kg) into height (squared m²).|baseline, week 3|||Kg/m²||Standard Deviation|Mean
2126|NCT02438540|Primary|Serotonin|changes in Serotonin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||ng/ml||Standard Deviation|Mean
2127|NCT02438540|Primary|Resistin|Changes in Resistin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||ng/ml||Standard Deviation|Mean
2128|NCT02438540|Primary|Glucagon-like Peptide-1 (GLP-1)|changes in GLP-1 blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
2129|NCT02438540|Primary|Adiponectin|Changes in Adiponectin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||µg/ml||Standard Deviation|Mean
2130|NCT02438540|Primary|Leptin|changes in Leptin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||ng/ml||Standard Deviation|Mean
2131|NCT02438540|Primary|Ceramides|Changes in ceramides blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||g/dl||Standard Deviation|Mean
2132|NCT02438540|Primary|High Density Lipoprotein Cholesterol (HDLc)|HDLc changes, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
2133|NCT02438540|Primary|Low Density Lipoprotein Cholesterol (LDLc)||baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
2134|NCT02438540|Primary|Triglyceride (TG)||baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
2135|NCT02438540|Primary|Free Fatty Acids (FFAs)|Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
2136|NCT02438540|Primary|C-reaction Protein (CRP)|CRP blood markers changes; Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mg/dl||Standard Deviation|Mean
2150|NCT02437305|Primary|Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention|The subject will complete 3 questionnaires: one pre-intervention, one post-intervention, and one 2 months post-intervention. Several questions will assess the participants knowledge of general melanoma, what it looks like and what are its risk factors. To determine participant retention, the pre-intervention and 2 month post-intervention questionnaires will be evaluated.|2 months post-intervention|||participants|||Number
2137|NCT02438540|Primary|Tumor Necrosis Factor-α (TNF-α)|Blood markers changes in TNF α, were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||Pg/ml||Standard Deviation|Mean
2138|NCT02438540|Primary|Interleukin-6 (IL-6)|IL-6 changes, IL-6 were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||Pg/dl||Standard Deviation|Mean
2139|NCT02438540|Primary|Fasting Insulin (FINS)|change of FINS,Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||µIU/ml||Standard Deviation|Mean
2140|NCT02438540|Primary|Fasting Blood Sugar (FBS)|changes FBS, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3|||mmol/L||Standard Deviation|Mean
2141|NCT02438540|Primary|Body Weight|The effect of Metformin and acupuncture combined therapy on weight loss (Change from baseline in body weight), body weight was measured while the subjects were dressed in light clothing after an overnight fasting and by a standard scale to an accuracy of +/-0.1 kg. All measures were recorded by one assessment, at baseline before the first time treatment, and before the last time treatment at week 3.|baseline, week 3|||kg||Standard Deviation|Mean
2142|NCT02437409|Secondary|No. of Passages Needed to Reach the Final TICI Score With pREset||while treatment (an expected average of 1h)|100 patients harboured 109 vessel occlusions||vessel occlusions|Participants||Number
2143|NCT02437409|Secondary|Recanalization of the Target Vessel|Thrombolysis in Cerebral Infarction (TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. The scale ranges from 0-3, 3 being the best mark. Grade 0 = no perfusion, Grade 1 = Penetration with Minimal Perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion.|after final recanalization (an expected average of 1h)|100 patients harboured 109 vessel occlusions||vessel occlusions|Participants||Number
2144|NCT02437409|Secondary|Time From Groin Puncture to Recanalization||during treatment (an expected average of 1h)|All Patients||minutes||Inter-Quartile Range|Median
2145|NCT02437409|Secondary|Patient Safety|Intracranial Hemorrhage|24 hr after treatment|All Patients||participants|||Number
2146|NCT02437409|Secondary|Neurological Condition of the Patient|"The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are:~Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2)~Best Gaze (0-2)~Visual (0-3)~Facial palsy (0-3)~Motor arm (0-4)~Motor leg (0-4)~Limb ataxia (0-2)~Sensory (0-2)~Best Language (0-3)~Dysarthria (0-2)~Extinction and Inattention (0-2)"|24 hr after treatment|All Patients||units on a scale||Inter-Quartile Range|Median
2147|NCT02437409|Secondary|Neurological Condition of the Patient|"modified Rankin Scale (mRS) Neurological Condition is measured by the Modified Rankin Scale (mRS). This scale ranges from 0 - 6, where 0 = No symptoms at all; 1 = able to carry out all usual duties and activities; 2 = unable to carry out all previous activities, but able to look after own affairs without assistance; 3 = requiring some help, but able to walk without assistance; 4 = unable to walk without assistance and unable to attend to own bodily needs without assistance; 5 = bedridden, incontinent and requiring constant nursing care and attention; 6 = dead"|24 - 72 hr after treatment and at discharge (an expected average of 7 days)|All Patients||participants|||Number
2148|NCT02437409|Secondary|Recanalization of the Target Vessel|Thrombolysis in Cerebral Infarction (TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. The scale ranges from 0-3, 3 being the best mark. Grade 0 = no perfusion, Grade 1 = Penetration with Minimal Perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion.|immediately after treatment, an expected average of 1 hour|100 patients harboured 109 vessel occlusions.||percentage of vessels with TICI 2b/3|Participants||Number
2149|NCT02437409|Primary|Neurological Condition of the Patient|"modified Rankin Scale (mRS) Neurological Condition is measured by the Modified Rankin Scale (mRS). This scale ranges from 0 - 6, where 0 = No symptoms at all; 1 = able to carry out all usual duties and activities; 2 = unable to carry out all previous activities, but able to look after own affairs without assistance; 3 = requiring some help, but able to walk without assistance; 4 = unable to walk without assistance and unable to attend to own bodily needs without assistance; 5 = bedridden, incontinent and requiring constant nursing care and attention; 6 = dead"|90 days after treatment|All Patients||participants|||Number
2254|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2||Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2151|NCT02437305|Primary|Number of Participants That Performed Regular Self-Skin Examinations|The subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 5 questions will assess whether or not the patient has completed skin-self examinations and knows which areas of the skin to pay attention to. The pre-intervention and 2 month post-intervention questionnaire will be evaluated to determine the number of participants that performed regular self-skin examinations.|2 months post-intervention|||participants|||Number
2152|NCT02436811|Primary|Changes in the Knowledge Score|The knowledge score was assessed by nine statements developed and tested in a pilot study including items related to breastfeeding, supplemental feeding, sugar intake, bottle use, oral hygiene, and use of fluoride toothpaste. These statements were rated on a three-level Likert scale, under the following options: “agree,” “neither agree nor disagree,” and “disagree,” in addition to “I don’t know.” Each correct answer received score 1 whereas incorrect answers such as “neither agree nor disagree” and “I don’t know” were assigned score 0. The final scores ranged from 0 to 9. Higher values indicate better outcomes.|The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.|||units on a scale||Standard Deviation|Mean
2153|NCT02436577|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
2154|NCT02436577|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
2155|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs i.e. Pulse (beats per minute [bpm]) were collected after the participant has rested in the supine position for at least 5 minutes.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart) and during treatment periods at pre-dose and post-dose at 2, 4 and 24 hours.|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||bpm||Standard Deviation|Mean
2156|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP)|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (pre dose, 2 hours, and 4 hours post dose) and Day 2 (24 hours post dose).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||mmHg||Standard Deviation|Mean
2157|NCT02436577|Secondary|Elimination Rate Constant (Kel) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of kel (elimination rate constant) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||1/hour||Standard Deviation|Geometric Mean
2158|NCT02436577|Secondary|Number of Participants With Adverse Events (AEs)|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|From the date of randomization (Day 1 of the first treatment period) until the final follow-up visit (5 to 10 days after last administration of IMP).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.||Participants|||Number
2159|NCT02436577|Secondary|Ratio of Metabolite AUC to Parent AUC, Adjusted for Differences in Molecular Weights (MRAUC) of Active Metabolite AR-C124910XX|Assessment of MRAUC (Ratio of metabolite AUC to parent AUC, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
2160|NCT02436577|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC [0-t]) of Active Metabolite AR-C124910XX|Assessment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
2161|NCT02436577|Secondary|MRCmax (Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights) of Active Metabolite AR-C124910XX|Assessment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
2162|NCT02436577|Secondary|Mean Residence Time (MRT) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of MRT (mean residence time) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||hours||Standard Deviation|Geometric Mean
2163|NCT02436577|Secondary|Terminal Elimination Rate Constant (λz) of Ticagrelor and Its Active Metabolite, AR-C124910XX.|Comparison of terminal elimination rate constant (λz) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||1/hour||Standard Deviation|Mean
2164|NCT02436577|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of t½λz (half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||hours||Standard Deviation|Mean
2165|NCT02436577|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of tmax (Time to reach maximum observed concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||hours||Full Range|Median
2176|NCT02436330|Secondary|Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of vegetable servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily vegetable intake. Analysis was completed on the available data.||servings||Standard Deviation|Mean
2166|NCT02436577|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC (Area under plasma concentration-time curve from zero to infinity) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2167|NCT02436577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration AUC (0-t) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC(0-t) (Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2168|NCT02436577|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of Cmax (maximum observed plasma concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the orodispersible (OD) tablet - when administered with and without water - and ticagrelor immediate-release (IR) tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The pharmacokinetic (PK) analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2169|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed again by participants in the Experimental group at 1 year. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from 6 month shuttle run at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Shuttle run was completed by 20/35 participants in the Experimental group at both 6 months and 1 year. Available data was analyzed."||number of runs||95% Confidence Interval|Mean
2170|NCT02436330|Secondary|Heart Rate Change||Change from 6 month Heart rate at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Heart rate data was collected at 6 month and 1 year for 27/35 of the participants. Available data was analyzed."||beats per minute||95% Confidence Interval|Mean
2171|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from 6 month Systolic BP at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Systolic blood pressure was only documented at 6 months and 1 year for 27/35 of the participants. Available data is what was analyzed."||mmHg||95% Confidence Interval|Mean
2172|NCT02436330|Secondary|Waist Circumference Change||Change from 6 month waist circumference at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Only 25/35 participants had waist measurements collected at both 6 months and 1 year. Available data was analyzed."||cm||95% Confidence Interval|Mean
2173|NCT02436330|Secondary|Exergaming Program Component Influence on Attendance|"The experimental group will answer a questionnaire at the end of the 6 month study period, measuring the importance of specific components of the curriculum and motivators which influenced enrollment and compliance with participation. Of interest is measuring the influence of the exergaming curriculum as compared to these other factors. This is a 16-item, 3-point Likert-scale (1 = least important and 3 = most important) questionnaire created specifically for this study. Results were reported based on % of participants rating 3 ,most important, for each curriculum component."|6 months|||percentage of subjects|||Number
2174|NCT02436330|Secondary|Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of sugar sweetened beverages per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 27/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding sugar sweetened beverage daily intake. Analysis was completed on the available data.||servings||Standard Deviation|Mean
2175|NCT02436330|Secondary|Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of fruit servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily fruit intake. Analysis was completed on the available data.||Servings||Standard Deviation|Mean
2177|NCT02436330|Secondary|Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total % dietary carbohydrates is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding %carbohydrates in their daily diet. Analysis was completed on the available data.||percentage of carbohydrates||Standard Deviation|Mean
2178|NCT02436330|Secondary|Change in Dietary Intake: % Fat (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total %dietary fat intake per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding the %fat in their daily diet. Analysis was completed on the available data.||percentage of fat||Standard Deviation|Mean
2179|NCT02436330|Secondary|Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total kcal/kg/day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response. Analysis was completed on the available data.||kcal/day||Standard Deviation|Mean
2180|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Global Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline to 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.||scores on a scale||Standard Deviation|Mean
2181|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Physical Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline at 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.||scores on a scale||Standard Deviation|Mean
2182|NCT02436330|Secondary|Activity Levels Measured by Pedometers (Weekly Steps)|Activity will be measured by pedometers (number of steps) during week 1 and week 24 for both groups. Subjects used the Yamax 200 pedometer to count the steps they took over 1 weeks time.|Change from week 1 to week 24|Missing data: Data was not available from all participants from pedometer use at both the 1 week and 24 week mark, therefore, this analysis only includes 13/35 participant data from the Experimental group and 10/13 participant data collected from the Active comparator group.||steps||Standard Deviation|Mean
2183|NCT02436330|Secondary|Saturday Screen Time as Assessed by Questionnaire|Change in Saturday screen time (reported out as fraction of an hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. Saturday screen time was defined as the amount of time spent on any screen, on an average Saturday, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change in hours from baseline at 6 months|"Missing Data: Survey data regarding Saturday screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."||hours||Standard Deviation|Mean
2184|NCT02436330|Secondary|After School Screen Time as Reported on Questionnaire|Change in after school screen time (reported out as fraction of 1 hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. After school screen time was defined as the amount of time spent on any screen, on the average weekday afternoon/evening, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change from baseline at 6 months|"Missing Data: Survey data regarding after school screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."||hours||Standard Deviation|Mean
2185|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed by participants at baseline (session 1) and at 6 months. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from baseline shuttle run at 6 months|Missing Data: Shuttle run was completed by participants at baseline and at 6 months to document the change in number of runs. Not all participants attended the 6 month measurement visit, therefore, complete data was only available on 24/35 of the Experimental group and 13/13 of the Active comparator group. Available data was analyzed.||number of runs||Standard Deviation|Mean
2186|NCT02436330|Secondary|Heart Rate Change From Baseline to 6 Months||Change from baseline at 6 months|Missing Data: Heart rate measurements at baseline and at 6 months was only available for 33/35 Experimental group participants and 12/13 Active comparator group participants. Not all participants attended the 6 month measurement/data collection visit.||beats per minute||Standard Deviation|Mean
2187|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from baseline Systolic BP at 6 months|Incomplete data available for analysis. Blood pressure was taken and documented at baseline and at 6 months, however, not all participants were in attendance. Complete data was only available for 33/35 Experimental group participants and 12/13 from the Active comparator group. Available data was analyzed.||mmHg||Standard Deviation|Mean
2188|NCT02436330|Secondary|Waist Circumference Change||Change from baseline at 6 months|Incomplete data available for analysis. Change in waist circumference from baseline to 6 month measurements was only collected on 34/35 of the Experimental group and 8/13 of the Active comparator group. The other participants did not show up for the 6 month measurements.||cm||Standard Deviation|Mean
2189|NCT02436330|Primary|BMI Z-score Change|Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).|Change from baseline BMI z-score at 1 year|Complete data was not available for all 35 subjects for this outcome measure. BMI z-score change from baseline to 1 year was only collected on 28 of the 35 participants.||z-score||95% Confidence Interval|Mean
2190|NCT02436330|Primary|BMI Z-score Change|All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).|Change from baseline at 6 months|||z-score||Standard Deviation|Mean
2191|NCT02435966|Secondary|Change in the Neck Disability Index Questionnaire||Pre-intervention (Day 1); after 2nd intervention (7 days)||||||
2192|NCT02435966|Secondary|Change in the Cervical Range of Motion Measured by Goniometer|Measured by goniometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)||||||
2193|NCT02435966|Secondary|Change in the Pressure Pain Threshold Measured by Algometer|Measured by algometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)||||||
2194|NCT02435966|Primary|Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days|The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)|||units on a scale||Standard Deviation|Mean
2195|NCT02435836|Primary|Percentage of Participants With Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Percentage of participants|||Number
2196|NCT02435836|Primary|Percentage of Participants With ECG Measurements of Potential Clinical Relevance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Percentage of participants|||Number
2197|NCT02435836|Primary|Percentage of Participants With Vital Signs of Potential Clinical Relevance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||percentage of participants|||Number
2198|NCT02435836|Primary|Number of Participants With Adverse Events (AEs)|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial.|Baseline to Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Participants|||Number
2199|NCT02435836|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2222|NCT02432040|Secondary|Percentage of Patients Achieving PASI-50 at the End of 3 Months|PASI-50 means at least a 50% reduction from baseline PASI score|3 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||percentage of participants|||Number
2223|NCT02432040|Secondary|Monthly Mean Changes in PASI Scores|PASI scores were measured monthly and mean changes from baseline for each month for the whole 6-month duration of the study recorded.|Monthly from baseline to 6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||units on a scale||Standard Deviation|Mean
2200|NCT02435836|Primary|Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week|BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2201|NCT02435836|Primary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week|The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2202|NCT02435836|Primary|Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, >34 = severe depression.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2203|NCT02435836|Primary|Mean Clinical Global Impression of Improvement (CGI-I) by Week|"The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5~=minimally worse; 6 = much worse; and 7 = very much worse."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2204|NCT02435836|Primary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2205|NCT02435836|Primary|Mean Change From Baseline in PANSS Negative Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2206|NCT02435836|Primary|Mean Change From Baseline in PANSS Positive Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2224|NCT02432040|Primary|Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months|Percentage of patients in each arm who will achieve 50% reduction in PASI scores at the end of 6 months will be compared|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||percentage of participants|||Number
2255|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1||Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2207|NCT02435836|Primary|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.||Units on a scale||Standard Deviation|Mean
2208|NCT02434939|Secondary|Incidence of Treatment Failure by Treatment Group.|Requiring more than two doses of the study medication provided for adequate pain control|120 minutes|||participants|||Number
2209|NCT02434939|Secondary|Incidence of Side Effects, Including Outlying Vital Signs|The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), Ramsay Sedation Scale (RSS) score at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. outlying vital signs recorded.( systolic Blood pressure less than 90mmHg or greater than 150mmHg, Heart rate less than 50bpm or greater than 150bpm, oxygen saturation below 90%, respiratory rate below 9breaths/minute or greater than 40breaths/minute and RSS of 1 or greater than 3) The RSS was used to asses the level of agitation or sedation caused by the intervention .the scale ranges from 1(anxious/agitated) to 6( no response to stimulus-deep sedation) with 2 being the optimal (cooperative, oriented and tranquil).A checklist for side effects like airway problems, allergic reactions, salivation, dysphoria,nystagmus, respiratory/cardiac arrest, awakening hallucinations, nausea/vomiting was used|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration|||participants|||Number
2210|NCT02434939|Secondary|Time to Maximal Analgesic Effect and Duration of Action of Ketamine|"Following dosage with study medication, the amount of time taken to demonstrate the maximal change in the patient's NRS pain score.~Maximal change in NRS pain score is to be defined as the largest change from patient's baseline pain score. Duration of maximal change is how long the patient's pain score remained at this level."|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration|||minutes||Standard Deviation|Mean
2211|NCT02434939|Primary|Maximal Change in NRS Pain Scores as a Percentage of Baseline NRS Pain Score.|Our primary outcome measurement was the maximum change on the verbal NRS pain scale compared with their initial score (baseline). The NRS was used to measure a patient's subjective level of pain on a scale from 0 (representing no pain at all) to 10 (the worst pain imaginable) using whole numbers. The NRS score was documented just prior to the administration of the study drug (time zero). After infusion of the study drug was complete, NRS scores were documented at 5, 10, 20, and then every 20 minutes thereafter up to 120 minutes. We stopped recording NRS scores prior to 120 minutes if the patient requested a third dose of the study drug, withdrew consent or developed a severe adverse effect.|5, 10, 20,25,30, 40,45,50 60, 80, 100, 120 minutes post drug adminstration|3 patients in ketamine arm withdrew consent after 20 minutes in to the study while 1 patient in morphine arm was discontinued due to urticarial for fear of a worsened reaction if reexposed to the drug as he required a second dose||percent change from baseline NRS score.||Standard Deviation|Mean
2212|NCT02434523|Secondary|Lost to Follow up||8 weeks|number of subjects in each arm who were lost to follow up||participants|||Number
2213|NCT02434523|Secondary|Side Effects|number of patients with side effects, type of side effects|8 weeks|||participants|||Number
2214|NCT02434523|Secondary|Voice Handicap Index|Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes|8 weeks|||units on a scale||Standard Deviation|Mean
2215|NCT02434523|Primary|Reflux Symptom Index|Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes|8 weeks|Patients who completed treatment and post-treatment questionnaire||units on a scale||Standard Deviation|Mean
2216|NCT02433366|Primary|Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)|The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.|Day 1|AF patients on treatment with Pradaxa®.||Percentage of Participants|||Number
2217|NCT02433366|Primary|Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)|"The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.~This Outcome measure is applicable only for the Physicians group."|Day 1|Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)||Percentage of Participants|||Number
2218|NCT02432040|Secondary|Adverse Events||6 months|||participants|||Number
2219|NCT02432040|Secondary|Mean Change in hsCRP Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included since they were the only ones who had another hsCRP reading after baseline.||nmol/L||Standard Deviation|Mean
2220|NCT02432040|Secondary|Mean Change in Lipid Profile Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included.||mg/dL||Standard Deviation|Mean
2221|NCT02432040|Secondary|Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months||6 months|The number of patients analyzed were the ones who completed the study. Intention-to-treat analysis was done.||units on a scale||Standard Deviation|Mean
3825|NCT02297308|Primary|Vascular Access Site Complications|Rate of VARC-2 defined vascular complications within 30 days of TAVI.|withn 30 days of TAVI procedure|||participants|||Number
2225|NCT02432040|Primary|Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months|Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 – none, 1 – slight, 2 – moderate, 3 – severe, and 4 – very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 – 0% involvement, 1 - <10%, 2 – 10-<30%, 3 – 30-<50%, 4 – 50-<70%, 5 – 70-<90%, 6 – 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.||units on a scale||Standard Deviation|Mean
2226|NCT02431741|Primary|Infection in the Wound (Signs of Clinical Infection)|Weekly Visual inspection of the wounds by the investigators, over 5 weeks|weekly|ITT population||participants|||Number
2227|NCT02431455|Secondary|Postoperative Respiratory Complication|atelectasis found on chest imaging, pneumonia, or re intubation|entire inpatient say, usually 1 to 7 days|||participants|||Number
2228|NCT02431455|Primary|Hypoxia 24 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.|24 hours postoperative|||participants|||Number
2229|NCT02431455|Primary|Hypoxia 12 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.|12 hours postoperative|||participants|||Number
2230|NCT02431455|Primary|Hypoxia 6 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.|6 hours postoperative|||participants|||Number
2231|NCT02431299|Secondary|Brief COPE Maladaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2232|NCT02431299|Secondary|UNCOPE Measure|"This meThis measure is a consumer rated substance abuse screener consisting of 6 yes or no questions. A response of yes is assigned a value of 1. The total number of yes responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues)."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2233|NCT02431299|Secondary|Medication Adherence Rating Scale|"This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as yes or no. A yes is assigned a value of 1. The scale ranges from 0 (no yes responses) to 10 (all yes responses endorsed). The total number of yes responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2234|NCT02431299|Secondary|Brief COPE Adaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2235|NCT02431299|Secondary|Adult State Hope Scale|"This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being Definitely False and 4 being Definitely True). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2236|NCT02431299|Secondary|Multidimensional Scale of Perceived Social Support|This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2237|NCT02431299|Secondary|Working Alliance Inventory Short Form|This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2238|NCT02431299|Primary|Illness Management and Recovery Treatment Integrity Scale|Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR.|3-Months|||units on a scale||Standard Deviation|Mean
2239|NCT02431299|Primary|Illness Management and Recovery Scale|Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.||units on a scale||Standard Deviation|Mean
2240|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2241|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2242|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2243|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2244|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2245|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2246|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||hr||Full Range|Median
2247|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||hours (hr)||Full Range|Median
2248|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.||mg/mL||Standard Deviation|Mean
2249|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The Pharmacokinetic (PK) Set included all participants in the safety set with at least 1 measurable plasma concentration.||ng/mL||Standard Deviation|Mean
2250|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2251|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2252|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2253|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2256|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 26|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2257|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 34|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
2258|NCT02430389|Secondary|Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations||10 minute window after head fixation|||participants|||Number
2259|NCT02430389|Primary|Mean Arterial Blood Pressure After Head Fixation||Ten minute window after head fixation|||mm Hg||Standard Deviation|Mean
2260|NCT02430090|Secondary|Number of Participants With Pain Scores on the Visual Analog Scale|Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement were recorded.|Up to 4 months||||||
2261|NCT02430090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.|Up to 4 months|||participants|||Number
2262|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration|For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]|1 hour post-operative recovery period|||minutes||Inter-Quartile Range|Median
2263|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time|For MAX-WAG measurements obtained every 30 seconds, we calculated the percentage of time in MAX-WAG [>2ppm] relative to the total collection period.|1 hour post-operative recovery period|||percentage of time||Inter-Quartile Range|Median
2264|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions|The measurement of Waste Anesthetic Gas in parts per million emanating from the patient between the standard oxygen mask and the ISO-Gard oxygen mask.|1 hour post-operative recovery period|||parts per million||Standard Deviation|Mean
2265|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients|The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.|1 hour post-operative recovery period|A study size of 100 randomized subjects will be used. Aforementioned sample size was determined to be able to detect an effect size of 0.57 that would provide 80% power and 5% type I error (95% confidence interval and p-0.05 level of significance). Two sample student t-test will be used to do data analysis.||parts per million||Standard Deviation|Mean
2266|NCT02427984|Secondary|Number of Participants Who Scored Positive for ALVAL|"Histological score defined by the valuation of staining It was possible to valuate this outcome only for 29 out of 40 patients MoM (due to the availability of periprosthetic tissues).~The arms CoC and controls were not studied for this issue because ALVAL could occur only in presence of Metals"|3 years|positive for ALVAL is +, negative for ALVAL is -||participants|||Number
2267|NCT02427984|Primary|Amplitude of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in amplitude (decibel) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years|||decibel||Full Range|Mean
2268|NCT02427984|Primary|Frequency of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in frequency (Hz) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years|||Hz||Full Range|Mean
2269|NCT02427984|Primary|Duration of Articular Noise Produced During Level Walking|"Measured by fast Fourier transform (FFT) expressed in duration (milliseconds)~This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)"|3 years|||milliseconds||Full Range|Mean
2270|NCT02427984|Primary|Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l|"Measured by Inductively coupled plasma mass spectrometry (ICP-MS), equipped with dynamic cell reaction (ELAN DRC II) and expressed in micrograms/liter.~Will be counted the number of patients with level os metals above 7micrograms/liter~This outcome is valuable only for MoM arm and Control arm (as comparison), because CoC arm patients don't wear device releasing this kind of metals."|3 years|the population was evaluated as number of patients with ions level above 7ug/l (attention limit)||participants above limit|||Number
2271|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one vaccination of TIV is reported.|Day 1 to Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data||Number of Subjects|||Number
2272|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.|Day 1 to Day 4 post vaccination|Analysis was done on the unsolicited safety set population i.e., all subjects who have post vaccination unsolicited adverse event data.||Number of Subjects|||Number
2273|NCT02427750|Primary|Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination (including 30 mins)|Analysis was done on the solicited safety set population i.e. all subjects who have post vaccination solicited local and systemic adverse event data.||Number of Subjects|||Number
8449|NCT02093702|Primary|Mean Change in Hemoglobin A1c (HbA1c) Levels||Baseline and 12 months|||mmol/mol||Full Range|Mean
2274|NCT02427750|Primary|GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.|"The antibody responses following one vaccination of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/Day 1 post vaccination|The analysis was performed on the PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
2275|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 post vaccination|The analysis was performed on the PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
2276|NCT02427750|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
2277|NCT02427750|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22/ Day1 post vaccination|The analysis was performed on the PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
2278|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm^2 achieving a post vaccination SRH area ≥ 25mm^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area > 4mm^2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination SRH areas."|Day 22 post vaccination|The analysis was performed on the PP dataset||Percentages of subjects||95% Confidence Interval|Number
2279|NCT02427750|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm^2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the per-protocol population (PP).||Percentages of subjects||95% Confidence Interval|Number
2280|NCT02427477|Primary|Subjective Overall Vision|Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).||units on a scale|Participants|Standard Deviation|Mean
2281|NCT02427477|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).||units on a scale|Participants|Standard Deviation|Mean
2297|NCT02423447|Secondary|PRO (Patient-reported Outcome)|Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.|End of study visit per intervention|Patients rated comfort on a scale of 1 (most comfortable) to 10 (most un-comfortable)||units on a scale||Full Range|Mean
2298|NCT02423447|Secondary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
2282|NCT02424565|Primary|Time to Significant Increase in Local Surface Temperature|Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant.|Every minute from baseline to 10 minutes|Intent-to-treat (ITT) population included all participants of safety population with any post-treatment assessment. Since no significant increase in surface temperature was observed in subjects for either treatment, therefore, number of subjects analyzed for this outcome is zero.|||||
2283|NCT02424149|Secondary|Trial of Void Results|Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.|Day of hospital discharge|For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void.||participants who failed trial of void|||Number
2284|NCT02424149|Secondary|Post-operative Urethral Discomfort Measured by Pain Scales|Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.|post operative day 1|||units on a scale||Standard Deviation|Mean
2285|NCT02424149|Secondary|Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR|this is a composite measure and will be reported as a single value for each arm as number of additional interventions|day of surgery (day 0)|||interventions|||Number
2286|NCT02424149|Secondary|Physician Confidence Measured by a Survey|"Surgeon response to the question: I am confident that ureteral injury was ruled out in this patient on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree"|day of surgery (day 0)|||units on a scale||Standard Deviation|Mean
2287|NCT02424149|Primary|Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room|Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.|Day of surgery|||seconds||Standard Deviation|Mean
2288|NCT02423993|Secondary|Quality of Life (SF36 Questionnaire)|"We assessed QoL changes during the study and differences of these changes between groups.~SF-36 questionnaire enabling evaluation of patient’s satisfaction with his health status and certain emotional characteristics. 36 items of the Questionnaire are grouped in 8 scales. Each scale ranges from 0 to 100, the latter representing full health."|4 months after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.||units on a scale||Inter-Quartile Range|Median
2289|NCT02423993|Secondary|Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)|Treatment compliance evaluation was based on frequency of SMBG and bolus calculator use as one of the factors mediating achievement of target plasma glucose level.|within 4 month of the study|||events||Standard Deviation|Mean
2290|NCT02423993|Secondary|Glycaemic Variability|"Several glucose variability scores was assessed: SD, MAGE, MODD, LI, HBGI, LBGI, MAG. For SAP users glucose variability scores were calculated from CGM data. For CSII users with SMBG only glucose variability scores were calculated from bolus calculator (Bolus Wizard) data."|within 4 month of the study||11/2015||||
2291|NCT02423993|Secondary|Nonsevere Hypoglycaemia Frequency|Nonsevere hypoglycemia is defined аs an episode of a blood glucose value of less than 70 mg per deciliter (3.9 mmol per liter). All hypoglycaemia episodes was reported in patients dairies and then will be assessed and compared between groups.|within 4 month of the study|||events per day||Standard Deviation|Mean
2292|NCT02423993|Secondary|Quality of Life (ADDQoL Questionnaire)|"Will be assessed QoL changes during the study and differences of these changes between groups.~ADDQoL Questionnaire includes 2 general scales and 18 specific scales. 2 general scales represent the general QoL and diabetes – dependent QoL (scales varies from -3 (worse) to +3 (better)). 18 specific scales represent the impact of diabetes on certain QoL parameters: working life, family life, social life, sex life, physical appearance, do physically, leisure, travel, confidence in ability, motivation, society reaction, future, finances, dependence, living conditions, freedom to eat, other’s , freedom to drink. All scales varies from -9 (worse) to +9 (better)."|4 month after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.||units on a scale||Standard Deviation|Mean
2293|NCT02423993|Secondary|Severe Hypoglycaemia Frequency|Severe hypoglycemia is defined аs an episode requiring assistance and will be confirmed by documentation of a blood glucose value of less than 50 mg per deciliter (2.8 mmol per liter) or recovery with restoration of plasma glucose.|within 4 month of the study|||events per month||Standard Deviation|Mean
2294|NCT02423993|Primary|HbA1c|HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.|4 month after CSII initiation|"The analysis was per protocol. Patients from group education groups were on MDI regymen and from standart education group were on insulin pump therapy during previously 4 months"||percentage||Inter-Quartile Range|Median
2295|NCT02423447|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
2296|NCT02423447|Primary|Dry Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention|||gram||Full Range|Mean
2299|NCT02423447|Primary|Wet Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention|||gram||Full Range|Mean
2300|NCT02423408|Secondary|Proportion of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders)|The Carvalho Responders refers to subjects with at least 2 categories of improvement in the VAS severity category.|2 hours|||Participants|||Count of Participants
2301|NCT02423408|Secondary|Proportion of Subjects Using Rescue Medication During the 24-hour Post-dose Period||24-hour post-dose period|||Participants|||Count of Participants
2302|NCT02423408|Secondary|Proportion of Subjects Pain Free at 15, 30, 60, 90 Minutes and 4 Hours Post-dose (Pain Will be Assessed by 4-point NRS, VAS, and Binary Yes/no Question)||15, 30, 60, 90 minutes and 4 hours post-dose|LOCF Analysis||Participants|||Count of Participants
2303|NCT02423408|Primary|Proportion of Subjects Pain Free|Proportion of subjects pain free at 2 hours post-dose (Pain will be assessed by 4-point NRS, VAS, and binary yes/no question)|2 hours|LOCF Analysis||Participants|||Count of Participants
2304|NCT02423317|Secondary|Number of Participants With Airway Trauma|Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.|5 minutes|||participants|||Number
2305|NCT02423317|Secondary|Number of Esophageal Intubation.|Insertion of tracheal tube inside the esophagus|5 minutes|||esophageal intubation|||Number
2306|NCT02423317|Secondary|Overall Intubation Success Rate.|It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.|5 minutes|||participants|||Number
2307|NCT02423317|Secondary|Percentage of Glottic Opening Scoring.|The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch|5 minutes|||percentage of glottic opening||Inter-Quartile Range|Median
2308|NCT02423317|Secondary|Ease of Intubation.|The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.|5 minutes|||scores on visual analogue scale||Inter-Quartile Range|Median
2309|NCT02423317|Secondary|Number of Intubation in First Attempts;|A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.|5 minutes|||Intubations|||Number
2310|NCT02423317|Primary|Time to Intubation|It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform|5 minutes|||seconds||Standard Deviation|Mean
2311|NCT02421211|Secondary|Number of Participants Not Achieving Sustained Virologic Response (SVR) Showing Emerging Mutation in HCV Nonstructural Protein 3/4A (NS3/4A), Nonstructural Protein 5A (NS5A), and Nonstructural Protein 5B (NS5B) Sequence||Up to end of follow-up phase (Week 12 of follow-up phase) in Panel 1 and Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Since the data was to be analysed in the participants who did not achieve SVR, but all the participants achieved SVR in the study. Therefore the data was not collected for this outcome measure.|||||
2312|NCT02421211|Secondary|Percentage of Participants With Viral Relapse|Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.|Up to Week 12 follow-up phase after EOT|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
2313|NCT02421211|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been <LLOQ while on treatment; 2) Other with confirmed detectable HCV RNA at the actual end of treatment (example, completed, discontinued due to AEs, withdrawal of consent).|Day 70 in Panel 1 and Day 56 in Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
2314|NCT02421211|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12)|SVR4 or SVR12 is defined as sustained virologic response 4 or 12 weeks after the actual EOT the participant has HCV RNA <LLOQ detectable or undetectable.|4 weeks after EOT (Week 4 of follow-up phase in Panel 1 and Panel 2) and 12 weeks after EOT (Week 12 of follow-up phase in Panel 1 and Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
2315|NCT02421211|Secondary|Percentage of Participants With On-treatment Virologic Response|"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: less than (<) lower limit of quantification (LLOQ) undetectable, <LLOQ detectable and <LLOQ undetectable/detectable."|Week 1, up to EOT (Week 10 in Panel 1 and Week 8 in Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||percentage of participants|||Number
2316|NCT02421211|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 10 Weeks for Panel 1 and 8 Weeks for Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||number of participants|||Number
2317|NCT02421211|Secondary|Fluctuation Index (FI) of Ledipasvir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||percentage fluctuation||Standard Deviation|Mean
2351|NCT02419001|Primary|Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.||2 weeks|||ng/mL||Standard Deviation|Mean
2318|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||ng/mL||Standard Deviation|Mean
2319|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||Hour||Full Range|Median
2320|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Ledipasvir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||ng/mL||Standard Deviation|Mean
2321|NCT02421211|Secondary|Fluctuation Index (FI) of Simeprevir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||percentage fluctuation||Standard Deviation|Mean
2322|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||ng/mL||Standard Deviation|Mean
2323|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||hour (H)||Full Range|Median
2324|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Simeprevir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The Intent-to-treat (ITT) analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
2325|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir|AUCtau is defined as area under the analyte concentration versus time curve during dosing interval tau, calculated by linear-linear trapezoidal summation.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||ng*h/mL||Standard Deviation|Mean
2326|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Ledipasvir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||ng/mL||Standard Deviation|Mean
2327|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||ng/mL||Standard Deviation|Mean
2328|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir|The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||nanogram hour per Milliliters (ng*h/mL)||Standard Deviation|Mean
2329|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Simeprevir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here 'N' signifies number of participants analysed for this outcome measure.||ng/mL||Standard Deviation|Mean
2330|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Simeprevir (SMV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
2331|NCT02420093|Primary|Change in Numeric Pain Rating Scale|"This questionnaire measures subjective perception of pain levels on a 0-10 (11 point) scale, with 0 being no pain and 10 being the worst pain imaginable."|Change from Baseline after 3 Weeks|||units on a scale||Standard Error|Mean
2332|NCT02420093|Primary|Change in Fingertip to Floor Flexibility Test|This test measures subjects flexibility in forward trunk bending while subject is standing on a block 20 cm high. Measurement is in centimeters from fingertip to edge of step, above or below the step edge.|Baseline and 3 Weeks|||centimeters||Standard Error|Mean
2333|NCT02420093|Primary|Change in Sorenson Test for Lumbar Muscle Endurance|This test measures a persons back strength in 1 repetition of holding a back posture in neutral as long as can while lying on their stomach, legs stabilized on a treatment table.|Baseline and 3 Weeks|||time in seconds||Standard Deviation|Mean
5894|NCT02188849|Secondary|Quadriceps Isometric Strength|Measurement of quadriceps isometric force using a quadriceps table|Twelve weeks|||Newtons||Standard Deviation|Mean
2334|NCT02420093|Primary|Change in Left and Right Hamstring Length Testing|This test measures left and right hamstring length of the subject while they are lying on their back. The angle between the femur and tibia/fibula were measured when the hip angle held constant at 90 degrees and knee in full amount of available knee extension. This measure will use inclinometers for measurement.|Baseline and 3 Weeks|||degrees||Standard Error|Mean
2335|NCT02420093|Primary|Change in Modified Oswestry Low Back Pain Disability Index|This questionnaire measures the impact subject's low back pain on functional tolerance levels. Scale range is 0-100 with the lower score indicating a higher functional / activity level as it relates to Low Back Pain.|Baseline and 3 Weeks|||units on a scale||Standard Error|Mean
2336|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale of satisfaction||Full Range|Mean
2337|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale of satisfaction||Full Range|Mean
2338|NCT02420041|Secondary|Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
2339|NCT02420041|Secondary|Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
2340|NCT02420041|Secondary|Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
2341|NCT02420041|Secondary|Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.||units on a scale||Full Range|Mean
2342|NCT02420041|Primary|Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|3 months post-procedure minus baseline|numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study||units on a scale||Full Range|Mean
2343|NCT02420041|Primary|Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|2 weeks post-procedure minus baseline|||units on a scale||Full Range|Mean
2344|NCT02420041|Primary|Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|30 minutes pre-procedure minus baseline|||units on a scale||Full Range|Mean
2345|NCT02420041|Primary|Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy|during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin|difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes|||minutes||Full Range|Mean
2346|NCT02419313|Secondary|Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale|This scale measures the amplitude of the tremor. For instance tremor of more than 4cm oscillation is grade 4. UPDRS tremor scale is 0-4 , 4 being severe tremor. Significant improvement for this protocol considered two grades of improvement .|4 Weeks|||participants|||Number
2347|NCT02419313|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks|||participants|||Number
2348|NCT02419313|Primary|Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale|The primary outcome measure in this protocol is significant improvement of tremor (equal or over 2 grade improvement) of the Unified Parkinson's Disease Rating Scale 4 weeks after Xeomin injection. The score is 0 to 4 , ) being no tremor and 4 severe tremor. The higher the score, the more severe the tremor.|4 weeks|||participants|||Number
2349|NCT02419001|Primary|Ceftriaxone PK Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) With (Period 2) and Without (Period 1) SYN-004.||2 weeks|||h*ng/mL||Standard Deviation|Mean
2350|NCT02419001|Primary|Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.||2 weeks|||hours||Standard Deviation|Mean
2352|NCT02418676|Secondary|Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients|Dosages were provided four times daily (04h, 10h, 16h and 22h) to each patient during the 15-day study period, giving a total of 60 doses. To obtain these dosages, a drop of blood of patients was placed on a colorimetric strip and blood glucose was measured with the use of an Accu Check Active® glucose meter. The mean of 60 dosages was calculated for each patient at the end of 15 days. For each group assessed, it was calculated the mean of the measurements of the five patients, resulting in a single value.|Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study.||mg/dL||95% Confidence Interval|Mean
2353|NCT02418676|Primary|Efficacy Index (%EI)|Every three days the pressure ulcers (PUs) of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos were evaluated for measurement of PUs and any kind of irritation. At the end of this stage, the properly gathered study data was interpreted using the analysis software Mobile Wound Analyzer® (MOWA). Healing efficacy indices (% EI) were calculated as percentage reduction in the wound size at days 3, 6, 9, 12 and 15 from treatment beginning (d0). The % EI of the wound size was calculated by the following equation: %EI= ((Vsp.day-Vi)/Vi))x100. Vsp.day refers to the diameter (mm) values measured at day 3, 6, 9,12 and 15, while Vi refers to the baseline value measured before treatment (d0). The most representative result of treatment efficacy was observed on day 15, therefore it was used to calculate the % EI. For each group assessed, it was calculated the mean % EI of the five patients, resulting in a single value.|Measured every 3 days for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with little tissue loss, and allow easy visualization of healing.||percentage (%)||95% Confidence Interval|Mean
2354|NCT02418234|Secondary|Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure|The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years|||percentage of total ctDNA||Full Range|Median
2355|NCT02418234|Secondary|Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure|The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years|||participants|||Number
2356|NCT02418234|Primary|Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient|The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.|up to 2 years|||percentage of total ctDNA||Full Range|Median
2357|NCT02418234|Primary|Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay|The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).|up to 2 years|||participants|||Number
2358|NCT02417532|Secondary|Timed up and go Test- Ability to Stand From Chair|Walk 3 m and turn around and walk back to the chair. (Functional test)|1 Day|Subjects who met all inclusion/exclusion criteria||Participants|||Count of Participants
2359|NCT02417532|Secondary|Participant Satisfaction Questionnaire|overall user satisfaction with the device|1 Day|All subjects meeting inclusion criteria||percentage of patients|||Number
2360|NCT02417532|Secondary|Competency of User, in First Use, in Autonomous Control of the Device in <10 Minutes|Competent ability of user to use device within the first 10 Minutes without assistance|1 Day|All patients meeting inclusion criteria||Participants|||Count of Participants
2361|NCT02417532|Secondary|User Transfer, in First Use|Ability to transfer to Rex in first use of device|1 day|All subjects meeting inclusion criteria||Participants|||Count of Participants
2362|NCT02417532|Primary|Adverse Events|absence of unexpected serious adverse events|1 day|||Participants|||Count of Participants
2363|NCT02417532|Primary|Completion of REXercise 2|Lateral Trunk Extension|1 day|All Subjects meeting inclusion criteria||Participants|||Count of Participants
2364|NCT02417532|Primary|Completion of REXercise 1|Bilateral Shoulder Abduction|1 day|All subjects meeting inclusion criteria||Participants|||Count of Participants
2365|NCT02417532|Primary|Completion of Transfer|Completion of transfer from wheelchair or bed to REX device|1 day|All subjects meeting inclusion criteria. Physically able to properly fit in REX.||participants|||Number
2366|NCT02417129|Secondary|Immunogenicity at Week 30|"Immunogenicity (rate of anti-drug antibodies) at Week 30 presented as the number of participants having Immunogenicity at Week 30.~This endpoint was not summarized for arm ' rituximab ', as two patient were randomized and treated with BI 695500, thus no patient was treated with rituximab in this trial."|Day 204 or end of study|Safety Analysis Set (SAF). As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.||participants|||Number
2367|NCT02417129|Secondary|Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)|Extrapolated area under the concentration-time curve of BI 695500 or rituximab in plasma at steady state over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ, ss) established by population pharmacokinetics.|Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.|||||
2377|NCT02415959|Secondary|Coefficient of Nitrogen Absorption (CNA)|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||percentage of nitrogen intake||Standard Deviation|Mean
2368|NCT02417129|Primary|Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab|"The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL).~The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment.~Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial."|From first administration of study medication until 30 weeks thereafter.|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.||participants|||Number
2369|NCT02416973|Primary|Percent Change From Baseline in Pain Scores|Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable).|60 days|Per protocol population results displayed. This results in a discrepancy in the number of participants provided above. Baseline characteristics include the entire intent to treat population.||Percent Difference||Standard Deviation|Mean
2370|NCT02416180|Secondary|Time Taken to Correctly Completing Inhaler Use at Day 14|If a participant made a critical error during the initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The HCP could have demonstrated the use of the inhaler a maximum of three times. Any errors made after this final demonstration were recorded. The time taken for the HCP to train the participant in the correct technique was recorded as T1: the time from when the participants started their demonstration of MDI use until they had completed their demonstration of MDI use (i.e., with no HCP support), T2: the time from when the HCP started to demonstrate/instruct device use until correct use was demonstrated by the participant (up to a maximum of three attempts only). T3 is defined as T1+T2, which is the time from when the participant started to demonstrate MDI use until correct use was demonstrated by the subject (up to a maximum of three attempts following demonstration by HCP).|Day 14|ITT Population||Minutes||Full Range|Median
2371|NCT02416180|Secondary|Number of Health Care Professional (HCP) Instructions Required on Day 14|Participant's inhaler use was assessed on Day 14 by the HCP against a predefined list of critical errors. If a participant made a critical error during this initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The participant was then asked to demonstrate inhaler use. Any errors were recorded by the HCP. If the participant made a critical error then the HCP repeated the demonstration of inhaler use to the participant for a second time. If the participant continued to make a critical error in the use of the inhaler, the HCP demonstrated the correct use of the inhaler and gave verbal instructions one more time and the participant was then asked to demonstrate inhaler use. Instructions are only given to subjects who make a critical error. Any errors made after this final demonstration were recorded.|Day 14|ITT Population||Participants|||Number
2372|NCT02416180|Secondary|Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14.|Inhaler use was assessed on Day 14 for overall errors. Overall errors included CEs or N-CEs. Demonstration of usage was with MDI and placebo, CE or N-CEs and even no errors were recorded. CEs were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. N-CEs were defined as: failure to inhale within 5 seconds of shaking the device; no exhalation before an inhalation; the inhalation manoeuvre was not slow and/or was not deep; dose coordination was sub-optimal but patient likely to have received some dose; more than one actuation during an inhalation manoeuvre; did not hold breath. The exact 95% confidence interval is for percent of participants making at least one CE after the first assessment of the MDI technique, and was calculated using exact binomial distribution.|Day 14|ITT population||Percentage of participants||95% Confidence Interval|Number
2373|NCT02416180|Primary|Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14|Participant's inhaler use was assessed on Day 14 by the health care professional (HCP) against a predefined list of critical errors (CEs). Critical errors were defined as errors that were most likely to result in no or only minimal medication being inhaled. The participants were asked to demonstrate their usage of the MDI using a placebo demonstration MDI by HCP, critical or non-critical errors (N-CEs) and even no errors made by the participants while using the MDI were recorded. Critical errors in using the MDI were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. 95% confidence interval (CI) is for the % of participants making at least one critical error after the first assessment of the MDI technique, and was calculated using the exact binomial distribution.|Day 14|Intent to Treat (ITT) population: comprised of all participants who were screened and received at least one dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
2374|NCT02415959|Other Pre-specified|Treatment Emergent Adverse Events|Treatment emergent adverse events will be summarized per treatment group|From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days|||participants|||Number
2375|NCT02415959|Secondary|Stool Weight|Total amount of stool weight during the collection period in grams|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||gram per 72 hours||Standard Deviation|Mean
2376|NCT02415959|Secondary|Stool Fat Content|Total amount of fat excreted during the stool collection period in grams.|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||gram per 72 hours||Standard Deviation|Mean
2398|NCT02413593|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
2378|NCT02415959|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).||percentage of fat intake||Standard Deviation|Mean
2379|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days|||(ng/mL)||Standard Deviation|Mean
2380|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days|||(hr*ng/mL)||Standard Deviation|Mean
2381|NCT02415439|Primary|Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days|||participants|||Number
2382|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days|||(ng/mL)||Standard Deviation|Mean
2383|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days|||(hr*ng/mL)||Standard Deviation|Mean
2384|NCT02415439|Primary|Number of Subjects With Adverse Effects After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days|||participants|||Number
2385|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
2386|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
2387|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
2388|NCT02414828|Primary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Maximum number of subjects with deterioration >15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)|182 Days|Subjects who were evaluated.||participants|||Number
2389|NCT02414828|Primary|Forced Vital Capacity (FVC)|Maximum number of subjects with deterioration >10% from baseline, at any time point, in forced vital capacity (FVC)|182 days|Subjects who were evaluated.||participants|||Number
2390|NCT02414828|Primary|Forced Expiratory Volume in One Second (FEV1)|Maximum number of subjects with deterioration >10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)|182 days|Subjects who were evaluated.||participants|||Number
2391|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose|||percentage of T Cell response||95% Confidence Interval|Median
2392|NCT02414828|Primary|Number of Participants With Solicited and Unsolicited AEs|All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.|182 days|||participants|||Number
2393|NCT02414152|Primary|Response to Anakinra in Corticosteroid Resistant Patients With SSNHL|Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.|120 days|Zero subjects were analyzed because both enrolled subjects were withdrawn after receiving 56 days of anakinra because no hearing improvement was noted. They did not complete the entire study.|||||
2394|NCT02413593|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
2395|NCT02413593|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
2396|NCT02413593|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
2397|NCT02413593|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
2399|NCT02413593|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
2400|NCT02413333|Secondary|Mean Osmolality in Lens Cases at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations||milliosmoles/kg (mOsm/kg)|Participants|Standard Deviation|Mean
2401|NCT02413333|Primary|Mean Residual Peroxide at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations||parts per million (ppm)|Participants|Standard Deviation|Mean
2402|NCT02413034|Primary|Sonication Cultures|Number of positive Sonication cultures (7)|14 days|||cultures|||Number
2403|NCT02413034|Primary|Positive Cultures|Number of positive Tissue Cultures (7)|14 days|||cultures|||Number
2404|NCT02412657|Secondary|Patients Overall Satisfaction|categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others|48 hours||||||
2405|NCT02412657|Secondary|Sleep Disturbance|Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)|24 hours and 48 hours||||||
2406|NCT02412657|Secondary|Residual Motor Block|Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)|24 hours and 48 hours||||||
2407|NCT02412657|Secondary|Pain Scores|On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)|every 6 hours during the first 48 hours after surgery||||||
2408|NCT02412657|Secondary|Total Opioid Consumption (mg)||48 hours after surgery||12/2017||||
2409|NCT02412657|Primary|Duration of Analgesia|Defined as the time between the performance of the block and the first analgesic request|48 hours after surgery|||hours||Inter-Quartile Range|Median
2410|NCT02411929|Secondary|Number of Participants Discontinuing Study Drug Due to Adverse Events (Periods 1 and 2)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 16 days|The Safety Population included all participants who received at least one dose of study drug.||Participants|||Number
2411|NCT02411929|Secondary|Number of Participants Who Experienced an Adverse Event (Periods 1 and 2)|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 33 days|The Safety Population included all participants who received at least one dose of study drug.||Participants|||Number
2412|NCT02411929|Secondary|Pharmacokinetic Parameter: Fraction Absorbed (Fa, Radioactivity in Urine) (Periods 1 and 2) (Dose Normalized)|Fraction absorbed is the fraction of the total ertugliflozin dose absorbed, regardless of the fate of that dose after absorption (i.e., metabolism, degradation, etc). Fraction Absorbed was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time zero to the time of last measurable concentration) following oral and IV administration of 14^C-ertugliflozin. Fraction of 14^C dose recovered in urine = 14^C total in urine in dpm/14^C total in dose in dpm|Part 1: pre- IV dose, 0-11 and 11-23 hrs. post IV dose, and 23 – 47, 47 – 71 and 71 – 95 hrs. until Day 5; Part 2: predose, 0-12 and 12-24 hrs. post dose, and then 24-hour intervals until Day 5|The estimated Fa Population included only the 6 participants with complete urine data for both treatments.||Fraction of 14^C dose recovered in urine||Geometric Coefficient of Variation|Geometric Mean
2413|NCT02411929|Secondary|Pharmacokinetic Parameter: Steady-State Volume of Distribution (Vss) Following IV Infusion - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Steady-State Volume of Distribution is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Liters||Geometric Coefficient of Variation|Geometric Mean
2420|NCT02411929|Secondary|Pharmacokinetic Parameter: (AUC Inf) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the dose. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
13069|NCT01945944|Secondary|ICU Length of Stay||during hospitalization (typically 4 days - 2 weeks)|||days||Inter-Quartile Range|Median
2414|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Volume of Distribution (Vz/F) Following Oral Administration - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug intravneous arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Liters||Geometric Coefficient of Variation|Geometric Mean
2415|NCT02411929|Secondary|Pharmacokinetic Parameter: Systemic IV Total Plasma Clearance (CL) - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Systemic clearance is a calculation of the rate at which a drug is removed from plasma via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||mL/min.||Geometric Coefficient of Variation|Geometric Mean
2416|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Oral Total Plasma Clearance (CL/F) - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Apparent clearance is a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug IV arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||mL/min.||Geometric Coefficient of Variation|Geometric Mean
2417|NCT02411929|Secondary|Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Hours||Standard Deviation|Mean
2418|NCT02411929|Secondary|Pharmacokinetic Parameter: Time for Cmax (Tmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. The confidence intervals displayed are minimums to maximums.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||Hours||Full Range|Median
2419|NCT02411929|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1) (Dose Normalized to 1 mg)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2442|NCT02406586|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 6 Weeks|Blood samples were collected for measurement of free fatty acids at baseline and 6 weeks after the Intralipid 20% infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 6-week FFA levels from baseline FFA levels.|Baseline, 6 weeks||||||
2469|NCT02406495|Secondary|Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
2421|NCT02411929|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV (Period 1) (Dose Not Normalized to 1 mg)|AUC0-last is a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2422|NCT02411929|Primary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) (Dose Normalized to 1 mg) and Absolute Oral Bioavailability (F) (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the drug dose. An absolute bioavailability provides information on the amount of a drug reaching the systemic circulation and can be determined by comparing the plasma concentration-time-curves (area under the curve) of a compound after oral application of that compound to that after intravenous application of the same compound.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The pharmacokinetic (PK) Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.||AUCinf(dn), ng•hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2423|NCT02411747|Primary|Global Rating Scale|The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale. A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures. GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure. Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25. At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.|Two to four weeks after day of simulation training|Two cystoscopies performed on patients by each participant||units on a scale|Participants|Standard Deviation|Mean
2424|NCT02406937|Secondary|Body Mass Index (BMI)|BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2 (kilogram per square meter).|Baseline, Week 4, Week 8, Week 12|||kg/m^2||Standard Deviation|Mean
2425|NCT02406937|Secondary|Sleeping Time|Questionnaire recorded by parents. Average sleeping time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12|||hours/day||Standard Deviation|Mean
2426|NCT02406937|Secondary|Milk Feeding Quantity|Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.|Baseline, Week 4, Week 8, Week 12|||ml/day||Standard Deviation|Mean
2427|NCT02406937|Secondary|Milk Regurgitation Frequency|Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.|Baseline, Week 4, Week 8, Week 12|||Times/day||Standard Deviation|Mean
2428|NCT02406937|Secondary|Chest Circumference||Baseline, Day 28, Day 56, Day 84|||cm||Standard Deviation|Mean
2429|NCT02406937|Secondary|Head Circumference||Baseline, Day 28, Day 56, Day 84|||cm||Standard Deviation|Mean
2430|NCT02406937|Secondary|Body Weight||Baseline, Day 28, Day 56, Day 84|||g||Standard Deviation|Mean
2431|NCT02406937|Secondary|Eczema Duration||Throughout the study period (84 days)|||Days||Standard Deviation|Mean
2432|NCT02406937|Secondary|Fecal Bacterium Concentration|bifidobacterium, lactobacillus, clostridium perfringens|Baseline, Day 21|||log (colony forming units)||Standard Deviation|Mean
2433|NCT02406937|Secondary|Fecal Laboratory Detection for sIgA||Baseline, Day 84|||ug/ml||Standard Deviation|Mean
2434|NCT02406937|Secondary|Number of Participants With Eczema||Throughout the study period (84 days)|||participants|||Number
2435|NCT02406937|Secondary|Body Length|Body length|Baseline, Day 28, Day 56, Day 84|||cm||Standard Deviation|Mean
2436|NCT02406937|Secondary|Fecal Concentration of Short Chain Fatty Acid|fecal concentration of acetate, propionate and butyrate acid|Baseline, Day 21|||mg/g||Standard Deviation|Mean
2437|NCT02406937|Secondary|Crying Time|Questionnaire recorded by parents. Average crying time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12|||minutes/day||Standard Deviation|Mean
2438|NCT02406937|Secondary|Stool Consistency|"Average Bristol Score during the measurement week. The seven types of stool are:~= Separate hard lumps, like nuts (difficult to pass)~= Sausage-shaped but lumpy~= Like a sausage but with cracks in its surface~= Like a sausage or snake, smooth and soft~= Soft blobs with clear-cut edges (passed easily)~= Fluffy pieces with ragged edges; a mushy stool~= Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing excess liquid, and 5, 6 and 7 tending towards diarrhoea."|Baseline, Week 4, Week 8, Week 12|||units on a scale||Standard Deviation|Mean
2439|NCT02406937|Secondary|Number of Participants With Gastrointestinal Symptoms|Number of participants with symptom of bloating and abdominal pain|Weekly (Baseline to Day 84)|||participants|||Number
2440|NCT02406937|Primary|Stool Frequency|Average daily stool frequency during the measurement week|Baseline, Week 4, Week 8, Week 12|||Times per day||Standard Deviation|Mean
2441|NCT02406586|Secondary|Change in Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in milliseconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Baseline, 6 weeks||||||
7872|NCT02108223|Secondary|Number of Mature Oocyte|median number of mature oocytes retrieved per participant|up to 9 month|||oocytes||Standard Deviation|Median
2443|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||percent change in diameter||Standard Deviation|Mean
2444|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||percent change in diameter||Standard Deviation|Mean
2445|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject on the salsalate arm withdrew from the study was not included in the baseline analysis population.||percent change in diameter||Standard Deviation|Mean
2446|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||percent change in diameter||Standard Deviation|Mean
2447|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
2448|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Week 6), within 20 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
2449|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Week 6), within 16 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
2450|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
2451|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure from at Week 6 from pre-dosing with Intralipid to 8 hours during Intralipid infusion.|Pre-dose (Week 6), within 8 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
2452|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Week 6), within 4 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.||mmHg||Standard Deviation|Mean
2467|NCT02406495|Secondary|Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D|Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
2468|NCT02406495|Secondary|Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.|1 Week|||percentage of participants|||Number
2453|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
2454|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Baseline), within 20 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
2455|NCT02406586|Secondary|Change in Expression of Inflammatory Biomarkers (Interleukin-1 (IL-1), Interleukin-6 (IL-6), Interleukin-12 (IL-12), Tumor Necrosis Factor Alpha (TNF-alpha), and C-Reactive Protein (CRP))|IL-1, IL-6, IL-12, TNF-alpha, and CRP are inflammatory biomarkers. Each was measured by using microsphere-based flow cytometric immunoassay. Change is the difference between 6-week inflammatory biomarkers from baseline inflammatory biomarkers.|Baseline, 6 weeks||||||
2456|NCT02406586|Secondary|Change in Augmentation Index (AIx)|AIx is a surrogate measure of peripheral arterial resistance and is measured by analysis of the pulse wave at the radial artery. The AIx is calculated as the ratio of the pulse pressure at the second systolic peak to that at the first systolic peak. Change is the difference between 6-week AIx from baseline AIx.|Baseline, 6 weeks||||||
2457|NCT02406586|Secondary|Change in Oxidative Stress Markers|Oxidative stress was measured by using liquid chromatography to collect plasma glutathione and glutathione disulfide. Change is the difference between 6-week plasma glutathione and glutathione disulfide from baseline plasma glutathione and glutathione disulfide.|Baseline, 6 weeks||||||
2458|NCT02406586|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Weeks|Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 6-week diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 6 weeks||||||
2459|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Baseline), within 16 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
2460|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
2461|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. from Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 8 hours during Intralipid.|Pre-dose (Baseline), within 8 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
2462|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Baseline), within 4 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.||mmHg||Standard Deviation|Mean
2463|NCT02406495|Secondary|Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D|Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
2464|NCT02406495|Secondary|Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D|Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
2465|NCT02406495|Secondary|Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D|Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
2466|NCT02406495|Secondary|Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D|Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week|||percentage of participants|||Number
2470|NCT02406495|Secondary|Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
2471|NCT02406495|Secondary|Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
2472|NCT02406495|Primary|Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D|Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.|Baseline and 1 Week|||percentage of eyes|||Number
2473|NCT02406495|Primary|Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D|"Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.~Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement"|Baseline and 1 Week|||percentage of mean lens tightness||Standard Deviation|Mean
2474|NCT02406495|Primary|Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D|"Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.~(Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)."|Baseline and 1 Week|||percentage of eyes|||Number
2475|NCT02406495|Primary|Lens Fit, Centration - Filcon IV 1 and Ocufilcon D|Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable|Baseline and 1 Week|||percentage of eyes|||Number
2476|NCT02406495|Secondary|Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).|Baseline and 1 Week|||units on a scale||Standard Deviation|Mean
2477|NCT02406495|Secondary|Visual Acuity - Filcon IV 1 and Ocufilcon D|Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).|Baseline and 1 Week|||LogMAR||Standard Deviation|Mean
2478|NCT02404649|Secondary|To Assess Implant Survival||2 years||||||
2479|NCT02404649|Secondary|Evaluate Crestal Bone Levels||2 years||||||
2480|NCT02404649|Secondary|Level of Bone Maturation||2 years||||||
2481|NCT02404649|Primary|Resonance Frequency Values of Dental Implants|Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.|8 months|||units on a scale||Standard Deviation|Mean
2482|NCT02403180|Secondary|Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.|Day 5, each product|Intention to treat participants with non-missing observations||diopter*logMar||Standard Deviation|Mean
2483|NCT02403180|Primary|Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear|Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.|Day 5, each product|Intention to treat participants with non-missing observations||arcsec||Standard Deviation|Mean
2484|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-100)||Standard Deviation|Mean
2485|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
2486|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
7873|NCT02108223|Secondary|the Number of Oocytes Retrieved|median number of oocytes retrieved per participant|up to 9 month|||oocytes||Standard Deviation|Median
2487|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
2488|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-10)||Standard Deviation|Mean
2489|NCT02402322|Secondary|Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.|Beck Depression Inventory-II (BDI-II), Spanish adaptation (38, 39). This 21-item self-reported instrument evaluates symptoms of depression. Score range:0- 63, with 3 levels of severity, 10-18 mild depression, 19-29 moderate depression and >30 severe depression.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-63)||Standard Deviation|Mean
2490|NCT02402322|Secondary|Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.|Beck Anxiety Inventory (BAI), Spanish adaptation . This 21-item self-reported instrument evaluates the cognitive and physical symptoms of anxiety. Score range:0- 63, with 3 levels of severity 0-21 mild anxiety, 22-35 moderate anxiety and 36-63 severe anxiety.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-63)||Standard Deviation|Mean
2491|NCT02402322|Primary|Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.|This 18-item scale evaluates sensitivity to anxiety symptoms on 3 dimensions: physical, cognitive, and social.There are 3 subscales, physical, cognitive, and social. For both the subscales (which range from 0 to 24) and the total scale (which range from 0 to 72), higher scores correspond to greater anxiety sensitivity.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-72)||Standard Deviation|Mean
2492|NCT02402322|Primary|Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.|Panic Disorder Severity Scale Self-Report (PDSS-SR). This 7-item scale assesses the severity of PD through questions about the frequency of panic attacks, associated distress, anticipatory anxiety, agoraphobic and interoceptive avoidance, and social and work impairment. Score range: 0-28. Scores up to 10 correspond with ‘‘mild,’’ those between 11 and 15 with ‘‘moderate,’’ and those at or above 16 with ‘‘severe’’ panic disorder.|Baseline, 8 weeks, 6 months.|||units on a scale (range= 0-28)||Standard Deviation|Mean
2493|NCT02402296|Secondary|Matrix Metallo-proteinase (MMP-1&9)|Their immuno-expression was assessed in the gingival samples harvested from the gingiva adjacent to hopeless teeth (planned to be extracted for dento-periodontal causes)|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.||percentage of change||Standard Deviation|Mean
2494|NCT02402296|Secondary|Gingival Index (GI)|"Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing~delayed bleeding on probing~immediate bleeding on probing~spontaneous bleeding"|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.||percentage of change||Standard Deviation|Mean
2495|NCT02402296|Secondary|Pocket Depth (PD)|It is the distance from the base of the pocket till the gingival margin using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings||percentage of change||Standard Deviation|Mean
2496|NCT02402296|Primary|Assessment of Change in Clinical Attachment Level (CAL)|It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis (LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings measurements||percentage of change||Standard Deviation|Mean
2497|NCT02402127|Secondary|Average Coefficient of Friction of Unworn Lenses|Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.|Day 1 (each product)|Intention to treat participants with non-missing observations||unitless|Participants|Standard Deviation|Mean
2498|NCT02402127|Primary|Average Coefficient of Friction of Worn Lenses at 16 Hours|Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1, Hour 16, each product|Intention to treat participants with non-missing observations||unitless||Standard Deviation|Mean
2499|NCT02401529|Secondary|Average Frequency of Meals Per Day|average frequency of meals (1 meal, 2 meals, if more specify)|average number of meals consumed per day for the 1st three days post-surgery|||participants|||Number
2500|NCT02401529|Secondary|Average Amount of Meal Per Day|adequacy of meals (inadequate, adequate)|3 days|||participants|||Number
2501|NCT02401529|Secondary|Onset of 1st Post-operative Oral Intake|feeding onset (1st day i. surgery day, 2nd day, 3rd day)|Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery|||participants|||Number
5895|NCT02188849|Primary|Rectus Femoris Cross Sectional Height|Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound|Twelve weeks|||cm||Standard Deviation|Mean
2502|NCT02401529|Primary|Total Number of Post-operative Vomiting Episodes|Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)|total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery|||participants|||Number
2503|NCT02401529|Primary|Occurence of Postoperative Vomiting|Postoperative vomiting occurrence (yes, no)|7 days|||participants|||Number
2504|NCT02401529|Primary|Duration of Post-operative Nausea|Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)|7 days|||participants|||Number
2505|NCT02401529|Primary|Onset of Post-operative Nausea|Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)|onset of 1st ocurence of nausea attack within the 1st week post-surgery|||participants|||Number
2506|NCT02401529|Primary|Occurence of Post-operative Nausea|Postoperative nausea occurence (yes, no)|7 days|||participants|||Number
2507|NCT02401529|Primary|Duration of Post-operative Pain|4 selections (1 day, 2 days, 3 days, if more specify)|number of days at which pain was experienced within the the 1st sevn days post -surgery|||participants|||Number
2508|NCT02401529|Primary|Maximum Severity of Post-operative Pain|5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)|The severest pain grade felt within a week|||participants|||Number
2509|NCT02401464|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
2510|NCT02401464|Secondary|Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
2511|NCT02401464|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
2512|NCT02401464|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
2513|NCT02401464|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.||participants|||Number
2514|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
2515|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
2516|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2517|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2518|NCT02400996|Primary|Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms|Of the 40 patients operated for Pancreatic Endocrine Neoplasms, using clinical criteria, histopathological analysis and preoperative imaging as gold standard, nonfunctioning and functioning tumours were identified. Similarly the number of benign and malignant lesions identified were recorded as per the WHO Classification of pancreatic endocrine tumours.|Each participant was followed up for a period of 5 years|||participants|||Number
2519|NCT02400710|Secondary|Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record|Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.|16 weeks|||participants|||Number
2520|NCT02400710|Primary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.|8 weeks|||units on a scale||Standard Deviation|Mean
2521|NCT02400333|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening, at admission on Day -1 to each treatment period and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
2522|NCT02400333|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||participants|||Number
2523|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs were collected after the participant has rested in the supine position for at least 5 minutes.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||bpm||Standard Deviation|Mean
2524|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||mmHg||Standard Deviation|Mean
2525|NCT02400333|Secondary|Percentage of Participants With Adverse Events (AEs).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.||percentage of participants|||Number
2526|NCT02400333|Secondary|Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX.|Assesssment of MRAUC [0-∞] (Ratio of metabolite AUC [0-∞] to parent AUC [0-∞], adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
2527|NCT02400333|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX.|Assesssment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
2528|NCT02400333|Secondary|Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX.|Assesssment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ratio||Geometric Coefficient of Variation|Geometric Mean
2529|NCT02400333|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h||Standard Deviation|Mean
2530|NCT02400333|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h||Full Range|Median
2531|NCT02400333|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
2638|NCT02389361|Secondary|Neuropathic Pain|Difference between groups in term of neuropathic pain (as measured by the DN4 score). The DN4 score is a score based on the answer to 10 items. 1 point by item. Thus DN4 Score range are between 0 and 10. A worse outcome is defined as a score > 3.|at 6 months||||||
2532|NCT02400333|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
2533|NCT02400333|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2534|NCT02399345|Secondary|Percentage of Subjects With Post-treatment Relapse|Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment|Up to 12 weeks after last actual dose of active study drug|ITT population||percentage of participants|||Number
2535|NCT02399345|Secondary|Percentage of Subjects With On-treatment Virologic Failure|Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).|6 weeks|ITT population||percentage of participants|||Number
2536|NCT02399345|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
2537|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline up to Day 14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||μg/mL||Standard Deviation|Mean
2538|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline to Day14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||microgram per mililitre(μg/mL )||Standard Deviation|Mean
2539|NCT02399163|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||microgram per square centimeter(μg/cm^2)||Standard Deviation|Mean
2540|NCT02399163|Secondary|Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||% SMHR||Standard Deviation|Mean
2580|NCT02396147|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2581|NCT02396147|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2541|NCT02399163|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|Per-protocol (PP) population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.||% SMHR||Standard Deviation|Mean
2542|NCT02399111|Secondary|Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation|This study was terminated prior to collection of data.|30 days||||||
2543|NCT02399111|Primary|Incidence of Wound Infection With Szilagyi Grade|This study was terminated prior to gathering of data.|30 days||||||
2544|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 12, “How likely to comply if prescribed?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2545|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 11, “How satisfied with product?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2546|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 10, “How bothersome was nasal irritation?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
2547|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 9, “Did product cause nasal irritation?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2548|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 8, “Did product feel soothing?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2582|NCT02396147|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2549|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 7, “Did medicine run out of nose?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2550|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 6, “Did medicine run down throat?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2551|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 5, “How satisfied with aftertaste?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
2552|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 4, “Did product have an aftertaste?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2553|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 3, “How satisfied not to have scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
2554|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 2, “How satisfied with scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
2583|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All volunteers who received one adalimumab injection.||(ng/ml)*hour||Inter-Quartile Range|Median
2704|NCT02380287|Secondary|Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days||||||
2555|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.|Delayed attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 1, “Did product have a scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population||Participants|||Number
2556|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes using immediate attributes questionnaire, Question 9, “Did product make want to sneeze?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no urgency; 1: very slightly urgency; 2: slightly urgency; 3: neither slightly nor moderately urgency; 4: moderately urgency; 5; markedly urgency; 6: very markedly urgency. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
2557|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Soothing|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 8, “Did product feel soothing?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
2558|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 7, “Did medicine run out of nose?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
2559|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 6, “Did medicine run down throat?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
2560|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 5, “How satisfied with immediate taste?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
2584|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received adalimumab injection.||(ng/ml)*hour||Inter-Quartile Range|Median
2585|NCT02395055|Primary|Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received one injection of adalimumab.||ng/ml||Inter-Quartile Range|Median
2561|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 4, “Did product have an immediate taste?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
2562|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 3, “How satisfied not to have scent/odor?” are summarized. The immediate’ attributes questionnaire was completed immediately following each trt in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
2563|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor|Immediate attributes questionnaire (ques) was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes ques, Question 2, “How satisfied with scent/odor?” are summarized. The immediate’ attributes ques was completed immediately following each treatment (trt) in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.||Participants|||Number
2564|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 1, “Did product have a scent/odor?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance (ANOVA) mixed model with participant as a random effect, and country, treatment, period, and Baseline (BL) rhinitis symptomatology subgroup (subgrp), and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population||Participants|||Number
2565|NCT02397915|Secondary|Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire|An overall preference questionnaire (OPQ) was used to evaluate participants’ attribute preference for nasal spray therapy for the given treatment. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. Products attributes included scent/odor, immediate taste, after taste, less drip through throat (LDTT), less run out of nose (LRON), more soothing, less irritating and urge to sneeze (UTS). The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment (tmt) in Period 2. Overall participant preferences were analyzed using Prescott’s test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country (ctry) and symptomatology (sym). All preference p-values were also adjusted for multiplicity using Hochberg’s method.|Approximately four minutes after the administration of the second treatment|PP Population||Participants|||Number
2566|NCT02397915|Primary|Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.|An overall preference questionnaire (OPQ) was used to evaluate participants’ preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott’s test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg’s method.|Approximately four minutes after the administration of the second treatment|Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them.||Participants|||Number
2611|NCT02393677|Secondary|Onset of Sensory Block||20 minutes||||||
2612|NCT02393677|Primary|Duration of Analgesia||upto 8 hours|||minutes||Standard Deviation|Mean
2637|NCT02389452|Primary|Change From Baseline in WOMAC A1 Subscore at Week 26|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).|ITT population.||units on a scale||Standard Deviation|Mean
2567|NCT02397655|Primary|Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography|"By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion.~By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion.~Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree."|30 days after subjects recruitment|We provide the vessel numbers with its stenosis degree ≥50% stenosis (including occlusion).||artery numbers|||Number
2568|NCT02396160|Secondary|Stress Incontinence Frequency|Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being stress incontinence frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||Number of stress incontinence episodes||95% Confidence Interval|Mean
2569|NCT02396160|Primary|Nocturia Frequency|Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being nocturnal frequency ≥2 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of nocturnal micturitions||95% Confidence Interval|Mean
2570|NCT02396160|Secondary|Urge Incontinence Frequency|Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urge incontinent frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of urge incontinence episodes||95% Confidence Interval|Mean
2571|NCT02396160|Secondary|Urinary Urgency Frequency|Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urgency urination frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of urgency episodes||95% Confidence Interval|Mean
2572|NCT02396160|Primary|Day Urinary Frequency|Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being day urination frequency ≥10 daytime micturitions per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.||number of diurnal micturitions per day||95% Confidence Interval|Mean
2573|NCT02396147|Secondary|Oral Clearance (CL/F) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||liters (L)/hr||Geometric Coefficient of Variation|Geometric Mean
2574|NCT02396147|Secondary|Terminal Phase Elimination Half-Life (T1/2) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||hours||Standard Deviation|Mean
2575|NCT02396147|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.||hours||Full Range|Median
2576|NCT02396147|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|From Day 1 to Day 26|Safety population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
2577|NCT02396147|Secondary|Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant|A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Days 1, 11, 21 and 26|Safety population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
2578|NCT02396147|Secondary|Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant|Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range.|Baseline and Days 4, 10, 14, 20, 24 and 26|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
2579|NCT02396147|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)|Safety population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
2705|NCT02380287|Primary|Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1320 Hours After the Single Subcutaneous Injection of BCD-085||57 days|||(ng/ml)*hour||Inter-Quartile Range|Median
2586|NCT02394665|Secondary|Patterns of Failure in Study Participants Post-Protocol Therapy|Patterns of Failure will be assessed by determining the number of failures that arise in-field compared to the number that arise out–of-field. In-field failure will be defined as those where greater than 80% of the recurrence volume was encompassed by the 95% prescription isodose line. In addition, we will also describe failures by three types: unifocal, multifocal and diffuse (multicentric including leptomeningeal dissemination).|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
2587|NCT02394665|Secondary|Change in Quality of Life From Baseline in Study Participants|Change in quality of life during radiation and across the longitudinal progression-free interval compared to baseline. Change of quality of life will be assessed and scored via the FACT-Br behavioral questionnaire.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
2588|NCT02394665|Secondary|Rate of Grade 3 or Higher Toxicity as a a Consequence of Study Therapy.|Rate of Grade 3 of Higher Toxicity in study participants as a consequence of study therapy.|2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
2589|NCT02394665|Secondary|Rate of Progression-Free Survival (PFS) in Study Patients|Rate of progression-free survival in study participants. Progression-free survival (PFS) is defined as the time elapsed from the start of study treatment to the date of documented progression events. For progression-free patients (without progression events), PFS will be censored at the last date of documented PF status.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
2590|NCT02394665|Primary|Rate of Overall Survival (OS) in Study Patients|The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.|||||
2591|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|7 day post procedure|||units on a scale||Standard Deviation|Mean
2592|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|3 day post procedure|||units on a scale||Standard Deviation|Mean
2593|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete activities of daily living (ADLs)|1 day post procedure|||units on a scale||Standard Deviation|Mean
2594|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|7 days post procedure|||units on a scale||Standard Deviation|Mean
2595|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|3 days post procedure|||units on a scale||Standard Deviation|Mean
2596|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|1 day post procedure|||units on a scale||Standard Deviation|Mean
2597|NCT02393950|Secondary|Quantitative EEG|Quantitative analysis of EEG|Pre-dose and at 1, 6 and 10 h post dose at each dose level||||||
2598|NCT02393950|Secondary|Dexterity and Reaction Times|Selected battery of psychomotor tests|Pre-dose and at 1 and 6h post dose at each dose level||||||
2599|NCT02393950|Secondary|Sedation Scores on a Visual Analogue Scale (VAS)|Assessment of sedation by subject|Pre-dose and at 1, 6 and 10.5h post dose at each dose level||||||
2600|NCT02393950|Secondary|Effect of ODM-106 on Growth Hormone Levels|Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.|Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.|Only timepoints 2 - 6h evaluated.||ng/ml||Standard Deviation|Geometric Mean
2601|NCT02393950|Secondary|Metabolite Screening in Plasma and Urine|Metabolite screening in plasma and urine after single dosing|Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level||||||
2602|NCT02393950|Secondary|Elimination Half-life of ODM-106|Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.|||h||Standard Deviation|Mean
2603|NCT02393950|Secondary|Time to Peak Plasma Concentration (Tmax) of ODM-106|tmax of ODM-106 after single oral dosing of Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level|||h||Full Range|Mean
2604|NCT02393950|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106|AUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level|||h*ng/ml||Standard Deviation|Mean
2605|NCT02393950|Secondary|Peak Plasma Concentration (cMax) of ODM-106|cMax of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.|||ng/ml||Standard Deviation|Mean
2606|NCT02393950|Primary|Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.|Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.|From screening up to 16 weeks|||subjects affected|||Number
2607|NCT02393677|Other Pre-specified|Complications||2 hours||||||
2608|NCT02393677|Other Pre-specified|Haemodynamic Changes||8 hours||||||
2609|NCT02393677|Secondary|Duration of Motor Block||6 hours||||||
2610|NCT02393677|Secondary|Onset of Motor Block||30minutes||||||
2613|NCT02392767|Other Pre-specified|Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase|"Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the percentage of the standard Quick value. In a person not receiving oral anticoagulation the normal Quick value is between 70 and 100%. The longer the patient's coagulation time, the lower the Quick value"|Intervention period of 4 weeks|||Percentage of the standard Quick value||95% Confidence Interval|Mean
2614|NCT02392767|Secondary|Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.|Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.|After intervention period of 4 weeks|||percentage of total hemoglobin||95% Confidence Interval|Mean
2615|NCT02392767|Secondary|Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.|ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test|After intervention period of 4 weeks|||µmol/l||95% Confidence Interval|Mean
2616|NCT02392767|Secondary|Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.|"Homocystein level in µmol/l was determined on the final day of the 4 week intervention period.~The first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)"|After intervention period of 4 weeks|||μmol/l||95% Confidence Interval|Mean
2617|NCT02392767|Secondary|Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.|The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.|Intervention period of 4 weeks|||mmHg||95% Confidence Interval|Mean
2618|NCT02392767|Primary|"Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta lnRHI)"|"Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index (lnRHI) which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side.~Normal lnRHI > 0.51, Abnormal lnRHI < 0.51"|Intervention period of 4 weeks|||Delta lnRHI [Index]||95% Confidence Interval|Mean
2619|NCT02392247|Primary|Clot Stiffness|Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) for each patient at each of 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU]||hPa|Participants|Standard Deviation|Mean
2620|NCT02392247|Primary|Clot Time|Coagulation Function assessed at 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU] over the course of cardiac surgery until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) obtained from each patient at each sampling time (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU)||min|Participants|Standard Deviation|Mean
2621|NCT02391714|Secondary|Baseline Mean Pain Scores|Baseline pain scores prior to IUD insertion is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|Before the IUD insertion procedure|||units on a scale||Standard Deviation|Mean
2622|NCT02391714|Secondary|Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS|Satisfaction will be measured using a 100mm Visual Analog Scale (VAS), with anchors 0mm for very satisfied and 100mm for very dissatisfied.|Prior to clinic discharge, which is an average of 15 minutes after the procedure|||units on a scale||Standard Deviation|Mean
2623|NCT02391714|Primary|Mean Maximum Procedural Pain Scores|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|2 minutes after the procedure.|||units on a scale||Standard Deviation|Mean
2624|NCT02389452|Secondary|Change From Baseline in WOMAC C Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant’s ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.||units on a scale||Standard Deviation|Mean
2625|NCT02389452|Secondary|Change From Baseline in WOMAC B Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.||units on a scale||Standard Deviation|Mean
7452|NCT02121860|Secondary|Levels of cCK18/M30|Caspase-cleaved cytokeratin levels (cCK18M30)|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose|||U/L||Inter-Quartile Range|Median
2626|NCT02389452|Secondary|Change From Baseline in WOMAC A Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.||units on a scale||Standard Deviation|Mean
2627|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.||units on a scale||Standard Deviation|Mean
2628|NCT02389452|Secondary|Time Between Initial and Repeat Synvisc-One Treatment|Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection.|Baseline up to Week 52|ITT population. Number of participants analysed = participants from ITT population who received repeat injection.||weeks||Standard Deviation|Mean
2629|NCT02389452|Secondary|Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported.|Baseline up to Week 52|ITT population. Number of participants analysed = participants with baseline and Week 52 data.||participants|||Number
2630|NCT02389452|Secondary|12-Item Short Form Health Survey (SF-12)|SF-12 health survey is a self-reported questionnaire to measure participant’s profile of functional health and well–being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported.|Baseline, Week 26, 52|ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively.||participants|||Number
2631|NCT02389452|Secondary|Clinician Observer Global Assessment (COGA) Score at Week 52|COGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant’s osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF).|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||participants|||Number
2632|NCT02389452|Secondary|Patient Global Assessment (PTGA) Score at Week 52|PTGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||participants|||Number
2633|NCT02389452|Secondary|Change From Baseline in WOMAC C Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant’s ability to move around and perform usual activities of daily living.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
2634|NCT02389452|Secondary|Change From Baseline in WOMAC B Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
2635|NCT02389452|Secondary|Change From Baseline in WOMAC A Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
2636|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.||units on a scale||Standard Deviation|Mean
8493|NCT02092649|Secondary|Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days||Baseline, 6 weeks, 12 weeks|||percent variability||Standard Deviation|Mean
2639|NCT02389361|Primary|Acute Pain|Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale.|In recovery room|||units on a scale||Standard Deviation|Median
2640|NCT02389088|Primary|Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II|Testosterone, Androstenedione and 17-OH Progesterone (nmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||nmol/L||Standard Deviation|Mean
2641|NCT02389088|Primary|LH and FSH During Phase I and Phase II|LH and FSH (IU/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||IU/L||Standard Deviation|Mean
2642|NCT02389088|Primary|Inhibin B During Phase I and Phase II|Inhibin B (ng/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||ng/L||Standard Deviation|Mean
2643|NCT02389088|Primary|Estradiol During Phase I and Phase II|Estradiol (pmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.||pmol/L||Standard Deviation|Mean
2644|NCT02388815|Primary|Point Accuracy|"Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.~The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences.~Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100."|14 days|One subject withdrew prior to having a sensor applied, another did not perform any blood glucose tests on the FreeStyle Libre. Neither subject could be included in the accuracy analysis, both are included in the safety analysis.||percentage of glucose results in zone A||95% Confidence Interval|Number
2645|NCT02388763|Secondary|High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat Subjects||VA unit||Standard Deviation|Mean
2646|NCT02388763|Primary|High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat||VA unit||Standard Deviation|Mean
2647|NCT02388074|Primary|Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants|"The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®.~Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed."|2 months|22 participants were evaluated by a cytopathologist. Of these 22, PAP-stained slides of 3 participants were unreadable, 14 participants had provided samples that were confirmed by PAP as inadequate and only 5 slides were confirmed by PAP as adequate deep lung sputum samples. These 5 samples were evaluated for the presence of RFCs.||number of RFCs per participant||Standard Deviation|Mean
2648|NCT02387801|Secondary|Time to at Least a 2 Point Improvement on the PatGA Score|The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.|Baseline though Week 12|All randomized participants.||Days||90% Confidence Interval|Median
2649|NCT02387801|Secondary|Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.|Baseline, Week 12|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
2650|NCT02387801|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA)|The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant’s hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction|Baseline, Week 12|All randomized participants.||percentage of body surface area||Standard Error|Least Squares Mean
35687|NCT01512745|Secondary|Percentage of Participants With Adverse Events||30 months|||percentage of participants|||Number
2651|NCT02387801|Secondary|Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)|"The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “Not at all,” “A little,” A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of “Not relevant” which is scored as “0”. For all questions, if unanswered the question is scored as “0”. Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint."|Baseline, Week 12|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
2652|NCT02387801|Secondary|Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score|The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint.|Baseline, Week 12|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
2653|NCT02387801|Primary|Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score|The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.|Baseline through Week 12|All randomized participants.||Days||90% Confidence Interval|Median
2654|NCT02387580|Primary|Piperaquine AUC(0–168 h)|PQP Area under the plasma concentration versus time curve|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2655|NCT02387580|Primary|Piperaquine Cmax|Piperaquine Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2656|NCT02387580|Primary|OZ439 AUC(0–168 h)|OZ439 Area under the plasma concentration (AUC) versus time curve|pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657|NCT02387580|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2658|NCT02387554|Other Pre-specified|Number of Paticipants With Adverse Events||3 months||||||
2659|NCT02387554|Secondary|Vz/F|Vz/F(Apparent volume of distribution)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
2660|NCT02387554|Secondary|CL/F|CL/F(Apparent clearance)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
2661|NCT02387554|Secondary|T1/2|T1/2(Terminal elimination half-life),|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
2662|NCT02387554|Secondary|Tmax|Tmax(Time to maximum concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
2663|NCT02387554|Secondary|AUCinf|AUCinf(Area under the curve to infinity)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
2664|NCT02387554|Primary|Cmax|Cmax(maxium concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||||
2665|NCT02387554|Primary|AUClast|AUClast(Area under the curve to the last measurable concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||Ratio(Comb/Alone)||90% Confidence Interval|Geometric Mean
2666|NCT02387502|Primary|Time of Intubation|Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.|up to 10 minutes|||seconds||Standard Deviation|Mean
2667|NCT02387268|Secondary|Percentage of Participants in Whom the Cecum Was Reached|A procedure was considered complete when the cecum was reached and visualized.|During the colonoscopy procedure|||percentage of participants||95% Confidence Interval|Number
2668|NCT02387268|Primary|Safety as Measured by Number of Serious Adverse Events and Major Complications.||Max of 9 days||||||
2669|NCT02387268|Primary|Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )|"Scale ranges- Min-0, Max-3 where:~0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.~= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.~= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.~= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy."|During the colonoscopy procedure withdrawal phase (10 min in average)|||percentage of participants||95% Confidence Interval|Number
2670|NCT02384070|Secondary|Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure||48 hours post procedure|||participants|||Number
2706|NCT02380261|Primary|Number of Participants With Ocular Clinical Signs and Discomfort Sensations|Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.||participants|||Number
2671|NCT02384070|Secondary|TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores|"Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding.~Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention"|Hospital Stay and after 30 days post PCI|||Patients|||Number
2672|NCT02384070|Primary|Thrombotic Complications||Hospital Stay and after 30 days post PCI|||Number of Patients|||Number
2673|NCT02383719|Primary|Clinician Assessment of Use With a Questionnaire|"With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes.~The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree"|During non-invasive ventilation with the oro-nasal mask|||units on a scale||Inter-Quartile Range|Median
2674|NCT02383420|Secondary|Pair Preference Rating Scale|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects||units on a scale|Participants|Standard Error|Mean
2675|NCT02383420|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 177 image pairs were included for the reader study. Of the 177 pairs, 160 were cadaver image pairs. A total of seventeen (17) adult live human subject pairs were included in the reader study.||units on a scale|Participants|Standard Error|Mean
2676|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 FHA and PRN was 33, 28, 28, 32 respectively.||Ratios||95% Confidence Interval|Geometric Mean
2677|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set||Ratios||95% Confidence Interval|Geometric Mean
2678|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 PT, FHA and PRN was 27, 32, 31, 32 respectively.||Ratios||95% Confidence Interval|Geometric Mean
2679|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.||IU/mL||95% Confidence Interval|Geometric Mean
2771|NCT02370615|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
2680|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.||IU/mL||95% Confidence Interval|Geometric Mean
2681|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|"Analysis were done on per protocol set (PPS) i.e., All subjects in the all enrolled set who provided immunogenicity data at V113_01E1 visit 1 and:~correctly received the vaccine in the V113_01 parent study~had no major protocol deviations leading to exclusion or were not excluded due to other reasons as defined prior to analysis"||IU/mL||95% Confidence Interval|Geometric Mean
2682|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
2683|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
2684|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
2685|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
2686|NCT02382640|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.||participants|||Number
2687|NCT02382640|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
2688|NCT02382640|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2689|NCT02382640|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat||Days 1 at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2690|NCT02381678|Primary|The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography|This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography|7-15 years after heart valve replacement surgery (during 2001-2007)|||Percentage of all subjects|||Number
2691|NCT02381418|Secondary|Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.||up to 3 weeks post vaccination|||participants|||Number
2692|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.||fold change||95% Confidence Interval|Mean
2693|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.||percentage of subjects||95% Confidence Interval|Number
2694|NCT02380287|Other Pre-specified|Frequency of Binding Antibodies to BCD-85 Formation||day 57||||||
2695|NCT02380287|Other Pre-specified|Frequency of Early Discontinuation Due to AE||57 days||||||
2696|NCT02380287|Other Pre-specified|Frequency of Grade 3-4 AEs||57 days||||||
2697|NCT02380287|Other Pre-specified|Frequency of Local Reactions||57 days||||||
2698|NCT02380287|Other Pre-specified|Total Frequency of AE/SAE||57 days||||||
2699|NCT02380287|Other Pre-specified|Mean Pain Score by VAS Assessment During Injection of BCD-085||day 1||||||
2700|NCT02380287|Other Pre-specified|Clearance of BCD-085 After Single Subcutaneous Injection||57 days||||||
2701|NCT02380287|Other Pre-specified|Constant of Elimination of BCD-085 After Single Subcutaneous Injection||57 days||||||
2702|NCT02380287|Other Pre-specified|Half-life of BCD-085 After Single Subcutaneous Injection||57 days||||||
2703|NCT02380287|Other Pre-specified|Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days||||||
2707|NCT02380261|Primary|Number of Participants With a Contact-dermatitis Adverse Reaction|Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.||participants|||Number
2708|NCT02379637|Secondary|Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)|Number of patients with adverse advents|7 Days|||participants|||Number
2709|NCT02379637|Primary|Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)|Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours|72 hours|Full Analysis set||log-transformed total cough count||Standard Deviation|Mean
2710|NCT02376998|Primary|Number of Participants With Major Adverse Events|Evaluation of mortality, renal failure, cerebrovascular accident.|from hospital discharge to 1 month after the procedure|No serious adverse events recorded||number of serious adverse events|||Number
2711|NCT02375373|Primary|Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.|Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.|Change from Day 31, Day 62, and Day 93|Due to the rate of withdrawal from this study only one participant completed and this data was used for the outcome measures.||sequences||97.5% Confidence Interval|Mean
2712|NCT02375347|Primary|Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.|"Compare the gut microbiota composition and overall diversity of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products, using 16S ribosomal RNA (rRNA) sequencing of fecal samples.~The use of Operational Taxonomic Units (OTUs) are used to classify clusters of similar bacterial groups. OTUs are species or group of species often used when only DNA sequence data is available.~This measure is the average amount of OTUs found for each time point."|Change in Baseline (Day 1, Day 7-9, and Day 14)|||Avg. Operational Taxonomic Units||Standard Error|Mean
2713|NCT02374398|Secondary|Adverse Events|Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA)|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||participants|||Number
2714|NCT02374398|Secondary|Cost Analysis|Charges per case.|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||Dollars||Standard Deviation|Mean
2715|NCT02374398|Secondary|Post Operative Blood Loss|"The estimated blood loss was determined with the Gross formula [23]. According to a review article published in 2013, Gross’s formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below:~Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV [Hematocritinitial – Hematocritfinal ] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two."|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||ml||Standard Deviation|Mean
2716|NCT02374398|Primary|The Change in Hematocrit (Ht) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.~iv TXA plus regular electrocautery.~iv placebo plus Aquamantys system and regular electrocautery.~iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||Volume % of RBC in blood||Standard Deviation|Mean
2717|NCT02374398|Primary|The Change in Hemoglobin (Hb) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.~iv TXA plus regular electrocautery.~iv placebo plus Aquamantys system and regular electrocautery.~iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups|||g/dl||Standard Deviation|Mean
2718|NCT02374346|Secondary|Factors Associated With Postoperative Headache|Demographic, anaesthetic and surgical factors associated with postoperative headache|6 months|||participants|||Number
2719|NCT02374346|Primary|Frequency of Postoperative Headache in Elective Surgery Patients|The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.|6 months|"Frequency of postoperative headache in total sample (n=446), Post-op Headache, no History of Headache (n=229), Post-op Headache, History of Headache (n=217), where n= number of participants analyzed"||participants|||Number
2720|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 40 mg (Regimen B) and Febuxostate XR 80 mg (Regimen C) in Fasted States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.||ng*hr/mL||Standard Deviation|Mean
2721|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.||ng*hr/mL||Standard Deviation|Mean
2722|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUCt) Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.||ng*hr/mL||Standard Deviation|Mean
2723|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.||ng*hr/mL||Standard Deviation|Mean
2724|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple time points (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration who received a single dose of study drug in Regimen B and C.||ng/mL||Standard Deviation|Mean
2725|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the Pharmacokinetic population (PK), all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.||ng/mL||Standard Deviation|Mean
2726|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (AUC0-72) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to 72 hours [AUC0-72]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.||mg⋅h/mL||Geometric Coefficient of Variation|Geometric Mean
2727|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (Cmax) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (maximum plasma concentration [Cmax]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.||microgram/millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2728|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on Pharmacokinetics (PK; AUC) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to infinity [AUC]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.||milligram x hour /millilitre (mg⋅h/mL)||Geometric Coefficient of Variation|Geometric Mean
2729|NCT02372097|Secondary|Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|Baseline up to 7 days after the last dose of study drug (Day 8) in each period|The safety analysis set included all participants who received study drug.||participants|||Number
2730|NCT02372097|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
2731|NCT02372097|Secondary|Number of Participants With TEAEs Related to Body Weight||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
2732|NCT02372097|Secondary|Number of Participants With TEAEs Related to Vital Signs||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
2733|NCT02372097|Secondary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)|Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29).|Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.||participants|||Number
2734|NCT02372097|Secondary|Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||per hour(hr-1)||Standard Deviation|Geometric Mean
2735|NCT02372097|Secondary|MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||hr||Standard Deviation|Geometric Mean
2736|NCT02372097|Secondary|Tmax: Time to Reach the Cmax for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||hour(hr)||Full Range|Median
2737|NCT02372097|Secondary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||ng*hr/mL||Standard Deviation|Geometric Mean
2738|NCT02372097|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||nanogram per milliliter(ng/mL)||Standard Deviation|Geometric Mean
2739|NCT02372097|Primary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.||nanogram hour per milliliter(ng*hr/mL)||Standard Deviation|Geometric Mean
2740|NCT02372071|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)|||mg/dL||Standard Deviation|Mean
2741|NCT02372058|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)|||mg/dL||Standard Deviation|Mean
2742|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'No Answer or Not Applicable'. The percents (of subjects who responded) that were 'Strongly Agree','Agree','Neutral' about views/behaviors related to self-monitoring blood glucose were calculated.|1 hour|Percent (of those who responded) who 'Strongly Agree', 'Agree', 'Neutral' was calculated for each statement. Abbreviations used: 'HCP' is HealthCare Professional and 'Acc' is Accuracy||Percentage of Participants Who Responded|||Number
2743|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree','Agree','Neutral' about each statement was calculated.|1 hour|||Percentage of Participants Who Responded|||Number
2744|NCT02371876|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) and +/- 12.5% (>= 100mg/dL YSI capillary plasma).|1 hour|||Percentage of BG Results|||Number
2745|NCT02371876|Secondary|Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI venous plasma) and +/- 15% (>= 100mg/dL YSI venous plasma).|1 hour|132 (134-2) Blood glucose results were analyzed. Venipunctures were unsuccessful for two subjects.||Percentage of BG Results|||Number
2746|NCT02371876|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|||Percentage of BG Results|||Number
2747|NCT02371876|Secondary|Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|126 (134-8) Blood glucose results were analyzed. Four subjects with low blood sugar did not attempt palm testing per protocol. Four subjects had low blood sugar; their palm results were not evaluable per protocol.||Percentage of BG Results|||Number
2748|NCT02371876|Primary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|||Percentage of BG Results|||Number
2749|NCT02370121|Secondary|Area Under the Curve of Insulin (AUCI)|The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.|week 12|||pmol/L/min||Standard Deviation|Mean
2750|NCT02370121|Secondary|Area Under the Curve of Glucose (AUCG)|The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.|week 12|||mmol/L/min||Standard Deviation|Mean
2751|NCT02370121|Secondary|2-hour Postload Plasma Glucose (2-h PG)|The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
2752|NCT02370121|Secondary|Very-low Density Lipoprotein (VLDL)|The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
2753|NCT02370121|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)|The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.|Week 12|||mmol/L||Standard Deviation|Mean
2754|NCT02370121|Secondary|Total Cholesterol (TC)|The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
2755|NCT02370121|Secondary|Body Mass Index (BMI)|The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.|week 12|||kg/m^2||Standard Deviation|Mean
2756|NCT02370121|Secondary|Body Weight (BW)|The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.|week 12|||kg||Standard Deviation|Mean
2757|NCT02370121|Primary|Insulin Sensitivity|The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].|week 12|||unitless||Standard Deviation|Mean
2758|NCT02370121|Primary|First Phase of Insulin Secretion|The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').|week 12|||unitless||Standard Deviation|Mean
2759|NCT02370121|Primary|Total Insulin Secretion|The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).|Week 12|||unitless||Standard Deviation|Mean
2760|NCT02370121|Primary|Diastolic Blood Pressure (DBP)|The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.|week 12|||mmHg||Standard Deviation|Mean
2761|NCT02370121|Primary|Systolic Blood Pressure (SBP)|The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.|week 12|||mmHg||Standard Deviation|Mean
2762|NCT02370121|Primary|Fasting Plasma Glucose (FPG)|The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
2763|NCT02370121|Primary|High-density Lipoprotein Cholesterol (HDL-C)|The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.|Week 12|||mmol/L||Standard Deviation|Mean
2764|NCT02370121|Primary|Triglycerides (TGs)|The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12|||mmol/L||Standard Deviation|Mean
2765|NCT02370121|Primary|Waist Circumference (WC)|The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.|Week 12|All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).||cm||Standard Deviation|Mean
2766|NCT02370615|Primary|Number of Participants With Clinically Significant Change From Baseline in Continuous Pulse Oximetry (SpO2) in Cohort 2||Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
2767|NCT02370615|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
2768|NCT02370615|Primary|Number of Participants Who Had Clinically Significant Changes From Baseline in 12-lead Electrocardiograms|Number of participants who had ECG findings changed from “within normal limit” or “abnormal, clinically significant” to “abnormal and clinically significant” after study drug administration.|Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
2769|NCT02370615|Primary|Number of Participants With TEAEs Related to Body Weight||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
2770|NCT02370615|Primary|Number of Participants With TEAEs Related to Vital Signs||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.||participants|||Number
4110|NCT02281422|Primary|Cmax - Peak Plasma Concentration|BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.|||ng/mL||Standard Deviation|Mean
2772|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
2773|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
2774|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng/mL||Standard Deviation|Geometric Mean
2775|NCT02370615|Primary|Urinary Excretion Ratio of Digoxin From 0 to 48 Hours Postdose in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
2776|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
2777|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
2778|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng/mL||Standard Deviation|Geometric Mean
2779|NCT02370615|Primary|Cumulative Urinary Excretion Ratio of TAK 272F and TAK 272-M-I From 0 to 72 Hours Postdose in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
2780|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||ng*hr/mL||Standard Deviation|Geometric Mean
2781|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2782|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for TAK 272F and TAK 272-Metabolite (M-I) in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2783|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data is not available for the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
2784|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data was not available for participants in the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
2785|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
2786|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
2787|NCT02370602|Secondary|Ratio of TAK-063 Metabolite M-I AUC( 0-24) to TAK-063 AUC (0-24)|AUC Ratio is the ratio of AUC values of the metabolite compared to the parent calculated by dividing AUC values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ratio||Standard Deviation|Mean
2788|NCT02370602|Secondary|Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Ratio is the ratio of Cmax values of the metabolite compared to the parent calculated by dividing Cmax values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ratio||Standard Deviation|Mean
2789|NCT02370602|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||liter/hour||Standard Deviation|Mean
2790|NCT02370602|Secondary|Average Plasma Concentration on Day 1 (Cavg) for TAK-063 and TAK-063 Metabolite M-I|Cavg is the average plasma concentration on Day 1, calculated as AUC(0-24)/24.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
2791|NCT02370602|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
2792|NCT02370602|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng*hr/mL||Standard Deviation|Mean
2793|NCT02370602|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||hour||Standard Deviation|Mean
2794|NCT02370602|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
2795|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters|"The percentage of participants with any markedly abnormal standard 12-lead ECG measurements.~QTc - Bazett's Interval (msec) is ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec"|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
2796|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study. BL=baseline. bpm=beats per minute.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
2797|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
2798|NCT02370602|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose of study drug (up to 46 days)|Safety analysis set included all participants who received at least one dose of study drug.||percentage of participants|||Number
2799|NCT02370602|Secondary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 23 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Data was not available for participants in the pilot cohort. Occupancy is reported for putamen only.|23 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis.||Percent||Standard Deviation|Mean
2846|NCT02368314|Primary|Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.||participants|||Number
36459|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
2800|NCT02370602|Primary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 3 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Occupancy is reported for putamen only.|3 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis..||Percent||Standard Deviation|Mean
2801|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
2802|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2803|NCT02370537|Primary|Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2804|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.||h*nanomole/mL (h*nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
2805|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2806|NCT02370537|Primary|Part B: Baseline Corrected Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) for Total Eicosapentaenoic Acid (EPA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The Pharmacokinetic (PK) Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.||hours*mcg per millilitre (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2807|NCT02370537|Primary|Part A: Serum TG Level.|For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).|7 days after enrollment.|The Per Protocol Analysis Set included all enrolled patients without an important protocol deviation.||millimole per litre (mmol/L)||Standard Deviation|Mean
2808|NCT02369341|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
2828|NCT02368457|Primary|Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).|"Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).~Intraoral bone exposure is measured in mm2."|From baseline to 1, 3, 6, and 9 months of starting treatment|mean of intraoral bone exposure (measured in mm2) from baseline to 1, 3, 6, 9, 12 and 18 months of starting treatment||mm2||Full Range|Mean
2809|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
2810|NCT02369341|Secondary|Duration of Solicited General Symptoms|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||days||Full Range|Median
2811|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAE was defined as at least one MAE experienced. Grade 3 was defined as MAEs that prevented normal activities and related was defined as MAEs assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject).|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||subjects|||Number
2812|NCT02369341|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||days||Full Range|Median
2813|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were Arthralgia, Fatigue, Gastrointestinal symptoms, Headache, Myalgia, Shivering, Sweating and Temperature (Oral). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
2814|NCT02369341|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
2815|NCT02369341|Secondary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2816|NCT02369341|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2817|NCT02369341|Secondary|MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Mean
2818|NCT02369341|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2829|NCT02368314|Secondary|Frequency of Other AE SAE||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
2830|NCT02368314|Secondary|Frequency of Strokes, Myocardial Infarction, Unstable Angina and Cardiovascular Death||During the treatment period (14 days) and follow-up period (till 60-th day)||||||
2831|NCT02368314|Secondary|Frequency of Heparin Induced Thrombocytopenia||During the treatment period (14 days)||||||
2832|NCT02368314|Secondary|Frequency of All Bleedings||During the treatment period (14 days)||||||
2819|NCT02369341|Secondary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2820|NCT02369341|Secondary|Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.|Antibody titers were expressed as GMTs. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
2821|NCT02369341|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
2822|NCT02369341|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|"SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2823|NCT02369341|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2824|NCT02369341|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2825|NCT02369341|Primary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
2826|NCT02369341|Primary|Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
2827|NCT02368457|Secondary|Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale|"Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).~To examine the LENT/SOMA scale prospectively using interviews and questionnaires~Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.~Maximum score: 36 Minimum score: 0~Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.~Scale categories:~Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings."|From baseline to 1,3, 6, 9 months of starting treatment|||units on a scale||Full Range|Mean
2833|NCT02368314|Secondary|Frequency of Other “Small” Bleedings||During the treatment period (14 days)||||||
2847|NCT02368314|Primary|Frequency of DVT.|Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).|During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.||participants|||Number
2848|NCT02368093|Primary|Good European League Against Rheumatism (EULAR) Therapeutic Response Rate||6 months|||participants|||Number
2849|NCT02367885|Secondary|GMT of SRH Antibody Titer (Vero Antigen)|GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
2850|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||fold increase||95% Confidence Interval|Geometric Mean
2851|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)|Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2), or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
2852|NCT02367885|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2|Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
2853|NCT02367885|Secondary|GMT of HI Antibody Titer (Vero Antigen)|GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
2854|NCT02367885|Secondary|GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||fold increase||95% Confidence Interval|Geometric Mean
2855|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)|Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
2856|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40|Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
2993|NCT02359877|Primary|AUC(0-∞), AUC(0-last) of Neopterin|Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration|0 to 672 hours|||(nmol/L)*hour||Inter-Quartile Range|Median
2857|NCT02367885|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
2858|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||fold increase||95% Confidence Interval|Geometric Mean
2859|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2) or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
2860|NCT02367885|Secondary|Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)|Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.||percentage of participants||95% Confidence Interval|Number
2861|NCT02367885|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|GMT of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in FAS (all participants who received at least 1 dose of study vaccination) who had available data for specified strain at specified post-baseline time points.||titer||95% Confidence Interval|Geometric Mean
2862|NCT02367885|Secondary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||fold increase||95% Confidence Interval|Geometric Mean
2863|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
2864|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
2865|NCT02367885|Primary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||fold increase||95% Confidence Interval|Geometric Mean
4460|NCT02259400|Primary|Failure of NIV Support|NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.|10 days|||participants|||Number
2866|NCT02367885|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years.|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||fold increase||95% Confidence Interval|Geometric Mean
2867|NCT02367885|Primary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
2868|NCT02367885|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
2869|NCT02367885|Primary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
2870|NCT02367885|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination)|All participants included in the full analysis set (FAS) (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.||percentage of participants||95% Confidence Interval|Number
2871|NCT02367885|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.||participants|||Number
2872|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.||participants|||Number
2873|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.||participants|||Number
2874|NCT02367170|Secondary|A Change in the Urinary Excretion Markers of Muscle Catabolism From Baseline|Investigators will determine the effects of IMST on urinary excretion markers of muscle catabolism in patients with CCI. Investigators hypothesize that exercise will decrease urinary markers of catabolism compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21||||||
2875|NCT02367170|Secondary|A Change in the Results of the Biomarkers of Inflammation From Baseline|Investigators will determine the effects of IMST on biomarkers of inflammation in patients with CCI. Investigators hypothesize that exercise will decrease markers of inflammation compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21||||||
2876|NCT02367170|Primary|A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients|In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will lead to improvements in all three measures. This study will provide information about possible effective respiratory muscle rehabilitation techniques that are likely to lead to reduced time patients will require mechanical ventilation and improved MIP and weaning outcome in long-term, failure to wean patients|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28||||||
2877|NCT02367066|Secondary|Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||L/h||Standard Deviation|Mean
2878|NCT02367066|Secondary|Plasma AZD1981 AUC(0-24h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2879|NCT02367066|Secondary|Plasma AZD1981 AUC(0-12h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2880|NCT02367066|Secondary|Plasma AZD1981 AUC(0-4h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2881|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mmol/L||Standard Deviation|Geometric Mean
2882|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
2883|NCT02367066|Secondary|Plasma Paracetamol AUC(0-t)||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||h*ng/ML||Geometric Coefficient of Variation|Geometric Mean
2884|NCT02367066|Secondary|Time of Maximum Plasma Paracetamol Concentration, t_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||h||Full Range|Median
2885|NCT02367066|Secondary|Plasma Paracetamol Maximum Concentration, C_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2886|NCT02367066|Secondary|Plasma AZD1981 AUC(1-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2887|NCT02367066|Secondary|Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2888|NCT02367066|Secondary|Plasma AZD1981 AUC(0-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2889|NCT02367066|Secondary|Plasma AZD1981 AUC(0-1h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2890|NCT02367066|Secondary|Time of Maximum Plasma AZD1081 Concentration, t_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||h||Full Range|Median
2891|NCT02367066|Secondary|Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2892|NCT02367066|Secondary|Fasting Insulin at Endpoint||Day 3 and Day 9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.||UIU/ML||Standard Error|Least Squares Mean
2893|NCT02367066|Secondary|Change From Baseline to Endpoint Fasting Beta-cell Responsiveness||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||10^-9*(L/kg)*min||Standard Error|Least Squares Mean
36460|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
2894|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mmol/L||Standard Deviation|Geometric Mean
2895|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mmol/L||Standard Deviation|Geometric Mean
2896|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mU/L||Standard Deviation|Geometric Mean
2897|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mU/L||Standard Deviation|Geometric Mean
2898|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
2899|NCT02367066|Secondary|Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
2900|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*mU/L||Standard Deviation|Geometric Mean
2901|NCT02367066|Primary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide|GGI=Glucose and GLP1 infusion AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*pmol/L||Standard Deviation|Geometric Mean
2902|NCT02367066|Primary|Change From Baseline to Endpoint MMTT C_max for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||nmol/L||Standard Deviation|Geometric Mean
2903|NCT02367066|Primary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose|MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.||h*nmol/L||Standard Deviation|Geometric Mean
2904|NCT02366923|Primary|Moisture Retention (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Full Range|Median
2905|NCT02366923|Primary|Moisture Retention (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Standard Deviation|Mean
2906|NCT02366923|Primary|Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Full Range|Median
2907|NCT02366923|Secondary|Subjective Comfort of Stenfilcon A and Delefilcon A|Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)|Up to 12 Hours of Wear|||units on a scale||Standard Deviation|Mean
2908|NCT02366923|Primary|Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Standard Deviation|Mean
2909|NCT02366910|Primary|Moisture Retention (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Full Range|Median
2910|NCT02366910|Primary|Moisture Retention (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||percentage of dehyrdation||Standard Deviation|Mean
2911|NCT02366910|Primary|Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Full Range|Median
2912|NCT02366910|Primary|Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.||absolute WC change||Standard Deviation|Mean
2913|NCT02366767|Secondary|Efficacy of Hybrid Closed-loop System in Comparison With Control|As measured by overall mean sensor glucose percent time in range 70-180 mg/dL.|6 days|Including only sensor data where the daily median ARD <15%.||Percent time||Standard Error|Mean
2914|NCT02366767|Secondary|Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the system initiating and operating properly for at least 75% of the time for 75% of subjects.~As measure by the completion of study enrollment procedures and education on system use within 2 hours for 75% of the subjects."|6 days|||participants|||Number
2915|NCT02366767|Primary|Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects~As measured by the number of events of system alerts of plasma glucose values >300 mg/dL lasting for more than one hour in all subjects.~As measured by number of events of serum ketones >3 mmol/L in all subjects~As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects"|6 days|10 subjects who completed study||Events|||Number
2916|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months|||units on a scale||Standard Deviation|Mean
2917|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months|||units on a scale||Standard Deviation|Mean
2918|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
2919|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months|||units on a scale||Standard Deviation|Mean
2920|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months|||units on a scale||Standard Deviation|Mean
2921|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
2922|NCT02366637|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct and indirect bilirubin, gamma-glutamyl transpeptidase [GGT], alkaline phosphatase, uric acid, albumin, total protein, high sensitivity C-reactive protein [CRP]); urinalysis (specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [only if urine dipstick was positive for blood or protein]).|Baseline up to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.||participants|||Number
2923|NCT02366637|Other Pre-specified|Change From Baseline in Pulse Rate|Pulse rate was evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||beats per minute (bpm)||Standard Deviation|Mean
2994|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin|Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively|||nmol/L*hour||Inter-Quartile Range|Median
2924|NCT02366637|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure|Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||millimeters of mercury (mmHg)||Standard Deviation|Mean
2925|NCT02366637|Other Pre-specified|Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to 200 msec; QRS interval >=200 msec or >=25/50% increase from baseline; QT interval >=500 msec; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.||participants|||Number
2926|NCT02366637|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.||participants|||Number
2927|NCT02366637|Secondary|Trough Plasma Concentration (Ctrough) of PF-03715455|Ctrough is the concentration prior to study drug administration.|Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As PK was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.|||||
2928|NCT02366637|Secondary|Maximum Observed Plasma Concentrations (Cmax) of PF-03715455||Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As pharmacokinetics (PK) was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.|||||
2929|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.|Baseline, Week 1 to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||liters||Standard Deviation|Mean
2930|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||liters||Standard Deviation|Mean
2931|NCT02366637|Secondary|Change From Baseline in Sputum Cell Counts Over 4 Weeks|Sputum cell counts included total neutrophils counts and differential (percent [%]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.|Baseline, Week 1 to Week 4|It was not meaningful to summarize sputum cell counts as there were too few participants in the sputum sub-study and, of those, too few adequate sputum specimens to be meaningfully summarized.|||||
2932|NCT02366637|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Baseline (Day 1), Day 29 (Week 4)|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.||liters||Standard Deviation|Mean
2933|NCT02366338|Primary|Number of Patients With at Least One Inappropriate MAI Criterion|Appropriateness of oral anticoagulants was evaluated by adapted versions of the MAI|1 day|||participants|||Number
2934|NCT02365688|Primary|Dynamic Hemodynamic Response to Fluid Resuscitation|Physiological parameters compared before and after fluid bolus for fluid resuscitation.|Up to 6 hours but not to exceed duration of surgical procedure|Reference devices were in disagreement so the algorithm could not be verified|||||
2935|NCT02364778|Secondary|Diameter Stenosis (DS)|Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS).|day 1|||percentage of 100||Standard Error|Mean
2936|NCT02364778|Secondary|SB Ostial Involvement|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD)|day 1|||mm||Standard Error|Mean
2937|NCT02364778|Secondary|SB Angle|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA)|day 1|||degree||Standard Error|Mean
2938|NCT02364778|Primary|MLD SB Diameter|Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)|day 1|||mm||Standard Error|Mean
2939|NCT02363478|Secondary|Changes in the Severity of Esophageal Symptoms at Week 4|Severity of esophageal symptoms (dysphagia, heartburn, regurgitation and chest pain) was measured on a 100-point visual analogue scale (VAS) ranging from 0 (absent) to 100 (very severe). Even minor decrease in the VAS score for each symptom at week 4 considered as improvement.|before and after 4 weeks buspirone administration|||units on a scale||Standard Deviation|Mean
2940|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration|||cm/sec||Standard Deviation|Mean
2941|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration|||sec||Standard Deviation|Mean
2942|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: i) Amplitude of Contractions at the Distal Part of the Esophagus and ii) Resting and Residual (Lower Esophageal Pressure) LES Pressure and IRP (Integrated Relaxation Pressure) at Week 4||before and after 4 weeks buspirone administration|||mmHg||Standard Deviation|Mean
2943|NCT02362373|Secondary|Number of Participants Continuing With IUD|Women continuing the IUD for contraception at 6 months|6 months|||participants|||Number
2944|NCT02362373|Secondary|Change in Seizure Frequency|Number of participants with increased, unchanged or decreased mean monthly seizure frequency.|baseline to 6 months|||participants|||Number
2945|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|3 out of 20 participants received oxcarbazepine while on IUD.||percentage of participants|||Number
2946|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.|from baseline to 6 months after LNG IUS insertion|5 out of 20 participants received levetiracetam while on IUD.||percentage of participants|||Number
2947|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|13 out of 20 participants received lamotrigine while on IUD.||percentage of participants|||Number
2948|NCT02362360|Primary|"Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good."|"Subjects will evaluate the fit to body for each product by answering the question How was the baseplates ability to fit to the body contours in the area around the stoma?. The question is answered with a 5-point scale ranging from very poor to very good."|21 +/- 3 days|||percentage of subjects answering|||Number
2949|NCT02362321|Primary|Rate of Need for Surgery Drainage|The rate of success of conservative management was defined as the number of patients not requiring surgery in each treatment group during the 6 months following enrollment.|Within 6 months|||participants|||Number
2950|NCT02361736|Secondary|Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point|ACR is calculated by the urine trace albumin divided by the urine creatinine|-1d, 0d, 1d, 3d, 5d after surgery|||ratio||Standard Deviation|Mean
2951|NCT02361736|Primary|Concentration of NGAL in Plasma on 5 Time Point.|concentration of NGAL in plasma on 5 time point. Biomarkers are measured by ELISA.|-1d, 0d, 1d, 3d, 5d after surgery|||ng/ml||Standard Deviation|Mean
2952|NCT02361736|Secondary|Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point|eGFR is calculated by concentration of creatinine and CKD-EPI2009|-1d, 0d, 1d, 3d, 5d after surgery|||mL/min/1.73m2||Standard Deviation|Mean
2953|NCT02361736|Secondary|Concentration of β2 Microglobulin in Urine||-1d, 0d, 1d, 3d, 5d after surgery|||mg/L||Standard Deviation|Mean
2954|NCT02361736|Primary|Concentration of IL-18 in Plasma on 5 Time Point||-1d, 0d, 1d, 3d, 5d after surgery|||μg/L||Standard Deviation|Mean
2955|NCT02361736|Primary|Concentration of IL-18 in Urine on 5 Time Point|IL-18 is mainly created from proximal kidney tubules which is a proinflammatory factor that can be detected in earlier urine of AKI animal models.|-1d, 0d, 1d, 3d, 5d after surgery|||μg/L||Standard Deviation|Mean
2956|NCT02361736|Primary|Concentration of NGAL in Urine on 5 Time Point|Neutrophil gelatinase–associated lipocalin (NGAL) is a small protein, which is filtered via the glomeruli and reabsorbed in the proximal tubules, and thus low concentrations of NGAL can be measured in the blood and urine.|-1d, 0d, 1d, 3d, 5d after surgery|||ng/ml||Standard Deviation|Mean
2957|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks|||units on a scale||Standard Error|Mean
2958|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks|||units on a scale||Standard Error|Mean
2959|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
2960|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||units on a scale||Standard Error|Mean
3006|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 14|Percentage of adults and babies with scaling on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
2961|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks|||units on a scale||Standard Error|Mean
2962|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
2963|NCT02360124|Secondary|Proportion of Inactive Root Caries Lesions|the proportion of active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination will be calculated. The calculation is to divide the number of caries lesions that have changed status from active to inactive (assessed in clinical examination) by the number of active caries lesions found at baseline|30 months|The participants were the active root caries lesions found at baseline in each group.||percentage of inactive root caries|||Number
2964|NCT02360124|Primary|Number of New Tooth Root Caries Lesions|the number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination|30 months|||new carious root surfaces||Standard Error|Mean
2965|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration, duration here is reporteds the average value from 20 chewing strokes in units of millisecond."|three month|||millisecond||Standard Deviation|Mean
2966|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration,amplitude is reported here as the average value from 20 chewing strokes in units of microvolts."|three months|||microvolts||Standard Deviation|Mean
2967|NCT02359955|Secondary|Masticatory Efficiency Index|the masticatory efficiency is tested after patient wears complete denture for three months,each patient was given 4 gram dry peanuts, chewed for 20 seconds, then spat in the receptacle and rinsed mouth residue. The peanut particles were diluted to 1000 ml with distilled water, stirred for 1 minutes and standing for 2 minutes to suspension. Absorbance values(av) were measured at the wavelength of 590nm in a spectrophotometer. The higher the masticatory efficiency, the smaller the peanut particles, then the higher the av value, vice versa. Value of av was used to represent masticatory efficiency. For each patient, the test was conducted three times, and the average value of av was taken as the final result. A lower masticatory efficiency index indicates larger peanut particle size observed.|three months|||index score||Standard Deviation|Mean
2968|NCT02359903|Other Pre-specified|Area Under the Plasma Concentration-time Curve at Steady State Phase||28 weeks||12/2016||||
2969|NCT02359903|Other Pre-specified|Maximum Concentration at Steady State||28 weeks||12/2016||||
2970|NCT02359903|Secondary|Frequency of Early Withdrawal Due to AE/SAE||30 weeks||||||
2971|NCT02359903|Secondary|Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected||screening / 14 weeks / 30 weeks||||||
2972|NCT02359903|Secondary|Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study||30 weeks||||||
2973|NCT02359903|Secondary|Total Frequency of AE/SAE Within the Whole Time of the Study||30 weeks||||||
2974|NCT02359903|Secondary|Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade||2 weeks||||||
2975|NCT02359903|Secondary|Mean Change of Chest Expansion Compared With Baseline||14 weeks / 30 weeks||||||
2976|NCT02359903|Secondary|Mean Change of SF36 Score Compared With Baseline||14 weeks / 30 weeks||||||
2977|NCT02359903|Secondary|Mean Change of MASES Score Compared With Baseline||14 weeks / 30 weeks||||||
2978|NCT02359903|Secondary|Mean Change of BASFI Score Compared With Baseline||14 weeks / 30 weeks||||||
2979|NCT02359903|Secondary|Mean Change of BASMI Score Compared With Baseline||14 weeks / 30 weeks||||||
2980|NCT02359903|Secondary|Mean Change of BASDAI Score Compared With Baseline||14 weeks / 30 weeks||||||
2981|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS40||14 weeks / 30 weeks||||||
2982|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS20||14 weeks / 30 weeks||||||
2983|NCT02359903|Secondary|Average Concentration of Infliximab at Steady State Phase||28 weeks||||||
2984|NCT02359903|Secondary|Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade||2 weeks / 28 weeks||||||
2985|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks||||||
2986|NCT02359903|Secondary|Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks||||||
2987|NCT02359903|Secondary|Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks||||||
2988|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade||2 weeks||||||
2989|NCT02359903|Secondary|Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.|2 weeks|||ng/ml||Inter-Quartile Range|Median
2990|NCT02359903|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade||2 weeks|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.||(ng/ml)*hour||Inter-Quartile Range|Median
2991|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM|Stage 2 BCD-054 - 180 mcg - SC/IM|4 weeks|||participants|||Number
2992|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Stage 1|4 weeks|||participants|||Number
2995|NCT02359877|Primary|AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM|Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration|0 to 672 hours|||(pg/ml)*hour||Inter-Quartile Range|Median
2996|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a|Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively|||(pg/ml)*hour||Inter-Quartile Range|Median
2997|NCT02359435|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy|Intention to treat||participants|||Number
2998|NCT02358876|Primary|Percentage of Kinesia One Assessments Performed|Percentage of Kinesia One assessments performed as directed|Two weeks|||percentage of home assessments completed||Standard Deviation|Mean
2999|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy.|4 weeks after end of all therapy (Study Week 16)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
3000|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)||12/2017||||
3001|NCT02358044|Secondary|Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days|Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
3002|NCT02358044|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.~The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial."|Up to Week 12|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
3003|NCT02358044|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|All Subjects as Treated (ASaT) population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
3004|NCT02358044|Primary|Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)|Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study was that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was non-inferior to the percentage in the SOF plus PR arm. A secondary statistical analysis was performed to determine whether the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was superior to the percentage in the SOF plus PR arm.|12 weeks after end of all therapy (Study Week 24)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.||percentage of participants|||Number
3005|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 14|Percentage of adults and babies with scaling on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3007|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 14|Percentage of adults and babies with scaling on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3008|NCT02357940|Primary|Percentage With Scaling on the Face at Day 14|Percentage of adults and babies with scaling on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3009|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 7|Percentage of adults and babies with scaling on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3010|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 7|Percentage of adults and babies with scaling on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3011|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 7|Percentage of adults and babies with scaling on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3012|NCT02357940|Primary|Percentage With Scaling on the Face at Day 7|Percentage of adults and babies with scaling on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3013|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 1|Percentage of adults and babies with scaling on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3014|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 1|Percentage of adults and babies with scaling on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3015|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 1|Percentage of adults and babies with scaling on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3016|NCT02357940|Primary|Percentage With Scaling on the Face at Day 1|Percentage of adults and babies with scaling on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3017|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3018|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3019|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3020|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3021|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3022|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3023|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3024|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3025|NCT02357940|Primary|Percentage With Edema on the Torso at Day 14|Percentage of adults and babies with edema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3026|NCT02357940|Primary|Percentage With Edema on the Legs at Day 14|Percentage of adults and babies with edema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3027|NCT02357940|Primary|Percentage With Edema on the Arms at Day 14|Percentage of adults and babies with edema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3028|NCT02357940|Primary|Percentage With Edema on the Face at Day 14|Percentage of adults and babies with edema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3029|NCT02357940|Primary|Percentage With Edema on the Torso at Day 7|Percentage of adults and babies with edema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3030|NCT02357940|Primary|Percentage With Edema on the Legs at Day 7|Percentage of adults and babies with edema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3031|NCT02357940|Primary|Percentage With Edema on the Arms at Day 7|Percentage of adults and babies with edema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3032|NCT02357940|Primary|Percentage With Edema on the Face at Day 7|Percentage of adults and babies with edema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3033|NCT02357940|Primary|Percentage With Edema on the Torso at Day 1|Percentage of adults and babies with edema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3034|NCT02357940|Primary|Percentage With Edema on the Legs at Day 1|Percentage of adults and babies with edema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3035|NCT02357940|Primary|Percentage With Edema on the Arms at Day 1|Percentage of adults and babies with edema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3036|NCT02357940|Primary|Percentage With Edema on the Face at Day 1|Percentage of adults and babies with edema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3037|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3038|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3039|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3040|NCT02357940|Primary|Percentage With Edema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3041|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3042|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3043|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3044|NCT02357940|Primary|Percentage With Edema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3045|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 14|Percentage of adults and babies with erythema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3046|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 14|Percentage of adults and babies with erythema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3047|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 14|Percentage of adults and babies with erythema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3048|NCT02357940|Primary|Percentage With Erythema on the Face at Day 14|Percentage of adults and babies with erythema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3049|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 7|Percentage of adults and babies with erythema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3050|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 7|Percentage of adults and babies with erythema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3051|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 7|Percentage of adults and babies with erythema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3052|NCT02357940|Primary|Percentage With Erythema on the Face at Day 7|Percentage of adults and babies with erythema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3053|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 1|Percentage of adults and babies with erythema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3054|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 1|Percentage of adults and babies with erythema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3055|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 1|Percentage of adults and babies with erythema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3056|NCT02357940|Primary|Percentage With Erythema on the Face at Day 1|Percentage of adults and babies with erythema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3057|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3058|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3059|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3060|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3061|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3062|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3063|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3064|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.||Percentage of participants|||Number
3065|NCT02357485|Secondary|Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).|Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.|baseline to 3 months|||seconds||Standard Deviation|Mean
3066|NCT02357485|Secondary|Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion|Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.|Baseline to 3 months|||degrees|Participants|Standard Deviation|Mean
3067|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain|Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).|Baseline to 1 year|||units on a scale|Participants|Standard Deviation|Mean
3068|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|"Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment).~WOMAC score: 0 (best) to 100 (worst)"|Baseline to 1 year|||units on a scale|Participants|Standard Deviation|Mean
3069|NCT02357485|Primary|Safety as Measured by Adverse Events|Adverse Events were recorded during the entirety of the study.|Entire Study (1 year)|All 6 participants were included in the analysis||percentage of participants|||Number
3070|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 24 hours|||mean number of doses used||Standard Deviation|Mean
3071|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 12 hours|||mean number of doses used||Standard Deviation|Mean
3075|NCT02356588|Secondary|Summed Pain Intensity Difference|"The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour.~The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|1 hour|||units on a scale||Standard Error|Least Squares Mean
3076|NCT02356588|Secondary|Healthcare Professional Global Assessment|Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours|||Percentage of HCPs||95% Confidence Interval|Number
3077|NCT02356588|Secondary|Patient Global Assessment|Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours|||Percentage of patients||95% Confidence Interval|Number
3078|NCT02356588|Secondary|Time-weighted SPRID24|Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|24 hours|||units on a scale||Standard Error|Least Squares Mean
3079|NCT02356588|Secondary|Time-weighted SPRID12|Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|12 hours|||units on a scale||Standard Error|Least Squares Mean
3080|NCT02356588|Secondary|TOTPAR24|Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief.|24 Hours|||units on a scale||Standard Error|Least Squares Mean
3081|NCT02356588|Secondary|TOTPAR12|Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief.|12 hours|||units on a scale||Standard Error|Least Squares Mean
3082|NCT02356588|Secondary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).|The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|24 hours|||units on a scale||Standard Error|Least Squares Mean
3083|NCT02356588|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).|"The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.~The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|12 hours|||units on a scale||Standard Error|Least Squares Mean
3084|NCT02355977|Secondary|Bacterial Load|Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.|7 days|The analyzed units of the gene load of bacteria are log10.||log10 (copies/ml)||Standard Deviation|Mean
3085|NCT02355977|Secondary|Bleeding on Probing|BOP is evaluated for the treated tooth using the sulcus bleeding index (SBI) by Muhlemann with a range of 0 (no bleeding) to 5 (profuse bleeding)|7 days|||units on a scale||Standard Deviation|Mean
3086|NCT02355977|Primary|Pocket Depth|PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.|7 days|||mm||Standard Deviation|Mean
3087|NCT02355275|Secondary|Numeric Pain Rating Scale|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain. This was measured at baseline (T1) and 4 weeks (T2)|4 weeks|||units on a scale||Full Range|Mean
3088|NCT02355275|Primary|Oswestry Disability Index|Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The score is calculated by totaling the values marked, divided by 50 x 100. The greater the score the greater the disability. For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound. This outcome measure was reported at baseline (T1) and 4 weeks later (T2).|4 weeks|||units on a scale||Full Range|Mean
3089|NCT02354833|Primary|Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP||At time of surgery, up to 2 hours|||mcg||Full Range|Median
3090|NCT02354833|Primary|Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP||At time of surgery, up to 2 hours|||mg||Full Range|Median
3091|NCT02354833|Secondary|Percentage of Participants Experiencing Both Nausea and Emesis||At time of surgery, up to 2 hours|||percentage of participants||95% Confidence Interval|Number
3092|NCT02354833|Primary|Number of Rescue Boluses to Maintain SBP|Number of rescue boluses to maintain the SBP within 100-120% of baseline|At time of surgery, up to 2 hours|||rescue boluses|||Number
3093|NCT02354599|Secondary|Number of Participants With Positive Response for Anti MT203 Antibody||Baseline, Hour 168, 336, Day 42, 84|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
3094|NCT02354599|Secondary|Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration||Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84|The pharmacodynamic analysis set was defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacodynamic data.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
3095|NCT02354599|Secondary|Terminal Elimination Half-Life (T1/2) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||day||Full Range|Median
3096|NCT02354599|Secondary|Maximum Observed Serum Concentrations (Cmax) of MT203||Predose and at multiple time points (up to Day 84) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
3097|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||ng*day/mL||Standard Deviation|Mean
3098|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Mean
3099|NCT02354599|Primary|Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
3100|NCT02354599|Primary|Number of Participants With TEAEs Related to Lung Functioning Monitoring||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
3101|NCT02354599|Primary|Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
3102|NCT02354599|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
3103|NCT02354599|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
3104|NCT02354599|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.||participants|||Number
3105|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 48 hours|||MUEs||Standard Deviation|Mean
3106|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 6 participants who received rescue medication|Through 24 hours|||MUEs||Standard Deviation|Mean
3107|NCT02353754|Primary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 72 hours postdose|||MUEs||Standard Deviation|Mean
3108|NCT02353572|Primary|Maximally Tolerable Dose (MTD) of Both Melphalan and Bortezomib as Combination|MTD is defined as one dose below that which 33% of patients within cohort experienced dose limiting toxicity. Unacceptable toxicity is defined as intractable veno-occlusive disorder, new onset of renal failure requiring dialysis, acute heart failure of New York Heart Association class III/IV, or interstitial pneumonia requiring ventilator management for longer than 3 days or grade 4 neuropathy. A 100-day mortality/toxicity rate of 3% or more is considered unacceptable. Will consider as evidence an observed 100-day mortality/toxicity rate whose lower one-sided 90% confidence bound exceeds 3%.|100 days|The study was terminated, study endpoints were not reached.|||||
3109|NCT02353468|Primary|Event Free Survival Rates by Land-mark Analysis|A Kaplan-Meier curve would have been used to describe the distribution.|up to 5 years|The study was terminated, study endpoints were not reached.|||||
3110|NCT02353442|Secondary|Pain and Function at 4weeks (Pre and Post Treatment)|For these measures, the SPADI (Shoulder Pain and Disabilities Index) questionnaire was used, pre and post treatment. The is a self-assessment questionnaire with 5 questions about pain and 8 about functional activities. The final score (0-100) of the questionnaire is provided in percentage and a maximum score of 100 implies the worst possible condition.|4 weeks|||scores on a scale||Standard Deviation|Mean
3111|NCT02353442|Secondary|Pressure Pain Threshold at 4weeks (Pre and Post Treatment).|It was measured by a digital algometer in kPa pre and post treatment.|4 weeks|||kPa||Standard Deviation|Mean
3112|NCT02353442|Secondary|Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).|The strength was evaluated with digital dynamometer in Newton pre and post treatment.|4 weeks|||Newton||Standard Deviation|Mean
3113|NCT02353442|Primary|Humeral Translations at 4weeks (Pre and Post Treatment).|It was assessed in millimeters with 3D system pre and post treatment.|4 weeks|||Millimeters||Standard Error|Mean
3114|NCT02353442|Primary|Scapular Kinematics at 4weeks (Pre and Post Treatment)|It was assessed in degrees with 3D system pre and post treatment.|4 weeks|||degrees||Standard Error|Mean
3115|NCT02351817|Primary|Product Acceptance|"Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products.~There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate.~The result presented below shows how many subjects preferred Test A/Test B over own product"|7 days per test period|One subject did not answer the preference question.||participants|||Number
3562|NCT02315989|Secondary|Percentage of System Errors|During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly.|Average 100 days after treatment.|||percentage of system errors|||Number
3116|NCT02351505|Secondary|Proportion of Patients Who go Off Treatment Due to Adverse Reactions or Even Those Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
3117|NCT02351505|Secondary|Tolerability of the Regimen Assessed Through Number of Patients Who Required Dose Modifications and/or Dose Delays||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
3118|NCT02351505|Secondary|Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0|The incidence of severe (grade 3+) adverse events or toxicities will be described.|Up to 4 years|||percentage of patients|||Number
3119|NCT02351505|Secondary|Frequency of Adverse Events Defined as Adverse Events That Are Classified as Either Not Related, Possibly, Probably, or Definitely Related to Study Treatment as Per NCI CTCAE v4.0|Summarized by descriptive statistics for each of the disease cohorts. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, review all adverse event data that is graded as 3, 4, or 5 and classified as either “unrelated” or “unlikely to be related” to study treatment in the event of an actual relationship developing.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
3120|NCT02351505|Secondary|Overall Survival|Kaplan-Meier curves will be used to estimate overall survival. Consider Cox proportional hazards models to explore a limited set of confounding factors.|Date of study registration to the date of event (i.e., death) or the date of last follow-up if no event has occurred at their last evaluation assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
3121|NCT02351505|Secondary|Disease Control Rate (CR, PR, and Stable Disease)|Estimates will be accompanied by exact binomial confidence intervals.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
3122|NCT02351505|Secondary|Objective Response Rate (Complete Response [CR] or Partial Response [PR]) by RECIST|The overall response rate will be calculated as the number of PRs and CRs divided by the total number of evaluable patients. Estimates will be accompanied by exact binomial confidence intervals as well.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
3123|NCT02351505|Primary|Progression Free Survival|Estimated by the method of Kaplan and Meier for each cohort. Appropriate one-sided 90% confidence boundary will also be calculated for the final test Kaplan–Meyer test statistic at 12 weeks.|Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study|||||
3124|NCT02350881|Secondary|Survival of the Implant.|The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||percentage of implants|Participants||Number
3125|NCT02350881|Primary|Pain at Rest|"Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
3126|NCT02350881|Primary|Pain During Walking|"Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
3127|NCT02350881|Primary|Walking Perimeter|"Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : improved, same, worsened."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
3128|NCT02350881|Primary|Pain at Pressure of MTP1|Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
3129|NCT02350881|Secondary|Bone Resorption|Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort||percentage of implants|Participants||Number
3130|NCT02350881|Secondary|Osteolysis|Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort||percentage of implants|Participants||Number
3131|NCT02350881|Primary|Pain at Passive Motion of MTP1|Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||Number of Implants|Participants||Number
3132|NCT02350881|Primary|AOFAS Hallux-MTP-IP - PAIN Score|Pain is a sub-score of the AOFAS Hallux-MTP-IP score and is measured on a scale of 40 points - the higher value represents a minimal pain.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort||units on a scale|Participants|Standard Deviation|Mean
3133|NCT02350881|Primary|AOFAS Hallux-MTP-IP Score - Overall|"AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points. The AOFAS total score is then ranging from 0 to 100 points. A result over 80 points is considered good, below 20 points as bad."|mean 6.9 years follow-up (range 5.2 - 9.5)|number of implants analyzed (70 implants in 64 patients)||units on a scale|Participants|Standard Deviation|Mean
3134|NCT02349711|Secondary|Regulatory T Cells (Tregs)|Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry|baseline and week 6|||percentage of CD4+ T lymphocytes||Standard Error|Least Squares Mean
3135|NCT02349711|Secondary|Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire|Symptoms included in this score are constipation, hard stools, and feeling of incomplete evacuation reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire. Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.|weeks 0, 1, 2, 3, 4, 5, 6, 7|||units on a scale||Standard Error|Mean
3136|NCT02349711|Secondary|Serum Total Immunoglobulin E (IgE)|Serum total immunoglobulin E (IgE) was quantified via ELISA|baseline and week 6|||ng/mL||Standard Error|Mean
3137|NCT02349711|Primary|Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ|MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)|up to 8 weeks from date of randomization|||units on a scale||Standard Error|Least Squares Mean
3138|NCT02349685|Secondary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.~The eradication rate was evaluated by per-protocol analysis (PP)"|6 weeks after completion of eradication|||participants|||Number
3139|NCT02349685|Primary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.~The eradication rate was evaluated by intention to treat (ITT)"|6 weeks after completion of eradication|||participants|||Number
3140|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.||microns||Standard Deviation|Mean
3141|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.||microns||Standard Deviation|Mean
3142|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.||microns||Standard Deviation|Mean
3143|NCT02348658|Secondary|Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.|Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
3144|NCT02348658|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
3145|NCT02348658|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
3146|NCT02348658|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
3147|NCT02348658|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.||participants|||Number
3148|NCT02348658|Primary|Urinary Excretion Ratio of AML|Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||percentage of dose|||Number
3149|NCT02348658|Primary|Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ|Urinary excretion ratio (percent [%] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||percentage of dose|||Number
3150|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
3151|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
3152|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
41434|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 24 months|||mmHg||Standard Deviation|Mean
3153|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
3154|NCT02348658|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML|AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng*hr/mL||Standard Deviation|Mean
3155|NCT02348658|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
3156|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)||Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||ng/mL||Standard Deviation|Mean
3157|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)||Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
3158|NCT02347488|Secondary|Potentially High Extubation Risk|Number of participants experiencing ETT movement >4cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)|||Participants|||Count of Participants
3159|NCT02347488|Secondary|Clinically Significant Movement|Number of participants experiencing ETT movement >1cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)|||Participants|||Count of Participants
3160|NCT02347488|Secondary|Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device|The patients were examined after surgery (both immediately after surgery and at the end of the recovery room period) to determine if the patient suffered any irritation or minor injury to the face and oral structures. The patients were asked to fill out a questionnaire after recovery with questions about their overall experience with specific relation to any irritation and/or minor trauma to their face, oral structures, throat, jaw, and temporomandibular joint.|Immediately after surgery and 1-3 days following surgery, before discharge.|29 patients returned the survey (one patient was aphasic post-op and could not compete the survey)||Participants|||Count of Participants
3161|NCT02347488|Primary|Change in ETT Position|The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the supine position was measured. The endotracheal tube, once secured with either tape or the Haider airway device, encountered an axial force to simulate the endotracheal tube being pulled from the mouth. The force increased over approximately 5 seconds until the target of 15 N was reached or until the principal investigator deemed that the force be aborted to prevent possible tracheal extubation. The change in position, measured in cm, was recorded.|5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).|||centimeters||Standard Deviation|Mean
3162|NCT02345720|Primary|Corneal Staining|The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.|30 Days Post Wear|The analysis population consists of all subjects that were dispensed a study lens.||percentage of upper corneal quadrant||Standard Deviation|Mean
3163|NCT02345720|Primary|Limbal Staining|Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.|30 Days Post Wear|The analysis population consist of all subjects that were dispensed a study lens.||percentage of limbal area||Standard Deviation|Mean
3164|NCT02345720|Primary|Upper Eye Lid Margin Staining|Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.|30 days Post wear|The analysis population consists of all subjects that were dispensed a study lens.||mm^2||Standard Deviation|Mean
3165|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|15 min after removal of the urodynamics catheters|||units on a scale||Full Range|Median
3166|NCT02344745|Secondary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|15 min after removal of the urodynamics catheters|||cm||Full Range|Median
3167|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|At the time of catheter placement|||units on a scale||Full Range|Median
3168|NCT02344745|Primary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|At the time of catheter placement|||cm||Full Range|Median
3169|NCT02343380|Secondary|Intra-individual Variations in the Values of Glucagon-like Peptide-1 After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
3170|NCT02343380|Secondary|Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||||
3173|NCT02343380|Secondary|Variation in Morning Triglyceride and Free Fatty Acid (FFA) Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Triglycerides and FFA values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.~FFA concentrations were measured by a fluorometric assay. Plasma triglycerides were assayed by enzymatic colorimetric method.~Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min|||mmol/l*h||95% Confidence Interval|Mean
3174|NCT02343380|Secondary|Variation in Morning Glucose and Insulin Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Glucose and insulin values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.~Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min|||ug/ml*h||95% Confidence Interval|Mean
3175|NCT02343380|Primary|Intra-individual Variation in Morning Diet-induced Thermogenesis (DIT) Evaluated by Calorimetric Exam After the Consumption of a Meal at 8:00 am Compared With Evening DIT Evaluated by Calorimetric Exam After the Consumption of the Same Meal at 8:00 pm|Indirect calorimetry by Deltatrac II (DATEX, Division of Instruments Corp. Helsinki, Finland) is used to measure the rate of energy expenditure before- and after- the meal.Diet-induced thermogenesis is considered as the difference between average after-meal and basal energy expenditure.|Before and 180-min from the beginning of the meal|||kcal/min||95% Confidence Interval|Mean
3176|NCT02343081|Primary|AUC0-∞|Extent of absorption of Temozolomide from time (0) to infinity (∞) will be measured after oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.||mcg*h/mL||Standard Deviation|Mean
3177|NCT02343081|Primary|AUC0-t|Extent of absorption of Temozolomide from time (0) to the last quantifiable concentration (t) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough)|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.||mcg*h/mL||Standard Deviation|Mean
3178|NCT02343081|Other Pre-specified|T1/2|Time required for Temozolomide plasma concentration to decrease by 50%|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|||hours||Standard Deviation|Mean
3179|NCT02343081|Other Pre-specified|Kel|Rate at which Temozolomide is removed from the body.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|||1/h||Standard Deviation|Mean
3180|NCT02343081|Secondary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs and SAEs will be collected from the start of study treatment and until two weeks post last dose. If AEs or SAEs extend in time and are not resolved before the end of the 2-week follow up period, this period shall last until the event/s are resolved.|Up to two weeks post last dose||||||
3181|NCT02343081|Primary|Cmax|Rate of absorption of Temozolomide (Cmax) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.||mcg/mL||Standard Deviation|Mean
3182|NCT02342561|Secondary|Description of Bacterial Skin Flora|Macroscopically unique colonies are isolated and analysed using Matrix-Assisted Laser Desorption/Ionization Time Of Flight analysis (MALDI-TOF). Finding are reported as prevalence of unique organism growth in the study population|Samples collected 75 minutes after drape application are analysed|||No. of cases|||Number
3183|NCT02342561|Primary|Bacterial Quantity|The bacterial quantity of the skin in sampled using the cylinder sampling method and incubated for 36-48 hours. Manually counted growth is reported as log10 Colony forming units (CFU)/cm^2|Measured after skin disinfection and 75 minutes after drape application|||Log10 CFU/cm^2||Inter-Quartile Range|Median
3184|NCT02342288|Secondary|Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients|The secondary outcome is to evaluate factors (age, gender, duration of procedure, blood loss, intraoperative fluids, blood pressure, and carbon dioxide levels) looking for correlations with intraocular pressure changes.|prone; every 15 minutes; 1 hr until end of surgery||||||
3185|NCT02342288|Primary|Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position|The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP – two eye average baseline IOP obtained at first prone measurement).|Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery|Subjects who were undergoing elective lumbar spine surgery.||mm Hg||95% Confidence Interval|Mean
3203|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline|||participants|||Number
4313|NCT02271477|Secondary|Total Amount of IV Fluid at the End of the Procedure|To assess if there is a difference between all treatments in the total quantity of fluids amount|30 minutes after spinal anesthesia|||milliliters (mL)||Inter-Quartile Range|Median
3186|NCT02342223|Secondary|Dermatology Life Quality Index (DLQI)|To evaluate the effects of Voluma injections on the subject’s quality of life (QOL) using the Dermatology Life Quality Index (DLQI). The DLQI is a validated 10-item questionnaire encompassing six different domains of QOL, including symptoms and feelings, daily activities, leisure, work/school, personal relationships, and treatment. Each question has four possible responses: “not at all/not relevant,” “a little,” “a lot,” and “very much” that corresponds to scores of 0, 1, 2, and 3, respectively, and a higher score suggests a higher level of QOL impairment. DLQI total score may range between 0 to 30.|Baseline to 12 months|||scores on a scale||Standard Deviation|Mean
3187|NCT02342223|Secondary|Subject Satisfaction Questionnaire (SSQ)|To evaluate the benefits and effects of Voluma injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.|12 months|||percentage of total participants|||Number
3188|NCT02342223|Secondary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post- treatment photography by participants.|Baseline to 12 months|||Participants|||Number
3189|NCT02342223|Secondary|Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated lipoatrophy over 12 months by assessing changes in the Carruthers Lipoatrophy Severity Scale (CLSS) based on pre/post intervention photography by principal investigator (PI). CLSS is a 4-point grading scale (1 to 4, with a greater number indicating higher severity of HIV FLA). Grade 1: mild and localized facial lipoatrophy. Grade 2: deeper and longer atrophy, with the facial muscles beginning to show through. Grade 3: atrophic area is even deeper and wider, with the muscles clearly showing. Grade 4: lipoatrophy covers a wide area, extending up toward the eye sockets, and the facial skin lies directly on the muscles.|Baseline to 12 months|||Participants|||Number
3190|NCT02342223|Primary|Percentage of Participants With Device or Procedure Related Adverse Events|To evaluate the safety of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by monitoring the incidence of adverse events (patient will keep a daily diary for initial 1 month and weekly phone calls will be made by study coordinator for initial 1 month to document possible adverse events, including injection site reactions, redness, bruising, swelling, and induration).|12 months|Common, transient adverse events reported in subject diaries include as follows.||percentage of total participants|||Number
3191|NCT02342223|Primary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator|"To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post-treatment photography by principal investigator (PI). GAIS is a 5-point rating scale, ranging from worse, no change, improved, much improved, and very much improved."|Baseline to 12 months|||participants|||Number
3192|NCT02342197|Primary|Number of Oocytes Retrieved||12 months|||oocytes||Standard Deviation|Mean
3193|NCT02341859|Secondary|Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)|6 hours|Preference is missing for 1 participant in the stenfilcon A/delefilcon A group whom did not answer preference question of which lens is preferred.||participants|||Number
3194|NCT02341859|Secondary|Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).|6 hours|||units on a scale||Standard Deviation|Mean
3195|NCT02341859|Secondary|Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).|Baseline, 3 hours, 6 hours|||units on a scale||Standard Deviation|Mean
3196|NCT02341859|Secondary|Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).|Baseline and 6 hours|||units on a scale||Standard Deviation|Mean
3197|NCT02341859|Secondary|Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).|Baseline, 3 hours, 6 hours|||units on a scale||Standard Deviation|Mean
3198|NCT02341859|Secondary|Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).|Baseline, 3 hours, 6 hours|||units on a scale||Standard Deviation|Mean
3199|NCT02341859|Secondary|Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours|||participants|||Number
3200|NCT02341859|Secondary|Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours|||participants|||Number
3201|NCT02341859|Secondary|Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline|||participants|||Number
3202|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours|||participants|||Number
3204|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|6 hours|||participants|||Number
3205|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|Baseline|||participants|||Number
3206|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)|6 hours|||participants|||Number
3207|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)|Baseline|||participants|||Number
3208|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)|6 hours|||participants|||Number
3209|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)|Baseline|||participants|||Number
3210|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)|6 hours|||participants|||Number
3211|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)|Baseline|||participants|||Number
3212|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)|6 hours|||participants|||Number
3213|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)|Baseline|||participants|||Number
3214|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.|6 hours|||participants|||Number
3215|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.|Baseline|||participants|||Number
3216|NCT02341859|Primary|Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)|6 hours|||microns||Standard Deviation|Mean
3217|NCT02341859|Primary|Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)|6 hours|||mm||Standard Deviation|Mean
3218|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
3219|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
3220|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
3221|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
3222|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
3223|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
4363|NCT02264821|Primary|Duration of Effective Analgesia|T0 until first request of morphine PCAIV|30 hours after spinal injection T0|||minutes||Inter-Quartile Range|Median
3224|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
3225|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|"Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe)~N - nasal, T - temporal, S - superior, I - interior"|Baseline|||units on a scale||Standard Deviation|Mean
3226|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
3227|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
3228|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours|||units on a scale||Standard Deviation|Mean
3229|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline|||units on a scale||Standard Deviation|Mean
3230|NCT02341482|Secondary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3231|NCT02341482|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3232|NCT02341482|Secondary|Number of Participants With Significant Change in Physical Examination From Previous Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3233|NCT02341482|Secondary|Number of Participants With Significant Change in Neurological Examination From Previous Examination|The extended neurological examination, performed by a board certified neurologist, included observations for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3234|NCT02341482|Secondary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) interval, beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, QT interval corrected for heart rate (QTc) interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline; and QTcF >=450 to <480, 480 to <500 and >=500 msec or >=30 to 60 msec increase and also >=60 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3264|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
41435|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 18 months|||mmHg||Standard Deviation|Mean
3235|NCT02341482|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate more than (<)40 or less than (>)120 beats per minute (bpm); systolic blood pressure (SBP) more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3236|NCT02341482|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], urine cotinine, and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3237|NCT02341482|Secondary|Apparent Oral Clearance (CL/F) of PF-04958242|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
3238|NCT02341482|Secondary|Predose Concentration (Ctrough) of PF-04958242||0 hour at Day 1,Day 2,Day 3,Day 4,Day 7,Day 10,Day 13,Day 16,and Day 17 (pre-dose)|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
3239|NCT02341482|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-04958242||Day 1 to Day 17|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
3240|NCT02341482|Secondary|Time for Cmax (Tmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.||hours||Full Range|Median
3241|NCT02341482|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
3242|NCT02341482|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval, Where Tau = 12 Hours (AUCtau) of PF-04958242|AUCtau = area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau = 12 hours. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.||picogram*hours per milliliter pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
3243|NCT02340338|Secondary|Number of Participants With Seroconversion|ELISA IgG against rTSST-1|through day 70|||participants|||Number
3244|NCT02340338|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Clinical observations and clinical laboratory values|through day 70|||participants with any solicited AE|||Number
3245|NCT02339246|Primary|Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate AUC(0-24).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.||hr*ng/mL||Standard Deviation|Mean
3246|NCT02339246|Primary|Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate C(max).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.||ng/mL||Standard Deviation|Mean
3282|NCT02335710|Primary|Kinematics Translations During Ramp up Activity|AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity|3 months post-operative|||mm||Standard Deviation|Mean
3283|NCT02335710|Primary|Kinematics During Squat to Stand (S2S) Activity|Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S|3 months post-operative|||degrees||Standard Deviation|Mean
3247|NCT02339246|Primary|Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate T(max).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.||hour||95% Confidence Interval|Median
3248|NCT02338336|Primary|Incidence of Zero Lesion Measurement|Percent of participants with lesion measurement either equal to 0 or greater than 0|6 weeks|ITT||percentage of participants|||Number
3249|NCT02338336|Primary|Lesion Assessment|Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data|6 weeks|Intent-to-treat||millimeters||Standard Deviation|Mean
3250|NCT02337959|Secondary|Pair Preference Rating|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects||units on a scale|Participants|Standard Error|Mean
3251|NCT02337959|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 139 image pairs were included for the reader study. Of the 139 pairs, 122 were cadaver image pairs. Fifty-two (52) of the cadaver image pairs were from pediatric cadavers and seventy (70) pairs were from adult cadavers. A total of seventeen (17) adult live human subject pairs were included in the reader study.||units on a scale|Participants|Standard Error|Mean
3252|NCT02336958|Primary|Amount (ml) of Local Anesthetic Supplemented by Surgeon||during the intraoperative period|||ml||95% Confidence Interval|Mean
3253|NCT02336958|Primary|Number of Patients With Required Supplementation of Local Anesthetic by Surgeon||during the intraoperative period|||participants|||Number
3254|NCT02336763|Secondary|Disease-specific Survival|Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
3255|NCT02336763|Secondary|Distant Failure Rates|Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
3256|NCT02336763|Secondary|Overall Survival||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
3257|NCT02336763|Secondary|Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4||More than 3 months after study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
3258|NCT02336763|Secondary|Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4||Within 3 months of study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
3259|NCT02336763|Primary|Reduction in Liver Metastasis||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.|||||
3260|NCT02336763|Primary|Progression-free Survival||Up to 5 years|Study terminated early no analysis conducted. Subjects would need to be followed for up to 5 years to answer this objective. Subject 1 was followed 5 months and subject 2 was followed 2 months. Therefore, data was not collected from any subject for this Outcome Measure.|||||
3261|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone|The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.|2 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
3262|NCT02336607|Secondary|The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of The change of pulse wave velocity at baseline and from at least one visit after randomization.||m/s||Standard Deviation|Mean
3263|NCT02336607|Secondary|The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||m/s||Standard Deviation|Mean
3323|NCT02331589|Secondary|Adiponectin|enzyme-linked immunosorbent assay|3 weeks of KRG|||pg/mL||Standard Deviation|Mean
3265|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
3266|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
3267|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
3268|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
3269|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||mmHg||Standard Deviation|Mean
3270|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||Percentage||95% Confidence Interval|Number
3271|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||Percentage||95% Confidence Interval|Number
3272|NCT02336607|Primary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.||14 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.||Percentage||95% Confidence Interval|Number
3273|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 60 minutes post meal.|60 minutes post-meal|||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
3274|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 30 minutes post meal.|30 minutes post-meal|||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
3275|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)|Difference score (trt-control) of blood glucose at 120 minutes post meal.|120 minutes post-meal|||Difference score, trt-control (mg/dL)||Standard Deviation|Mean
3276|NCT02336438|Secondary|Difference Score: Percent of Time With Elevated Blood Glucose|Percent of time within hyperglycemic blood glucose range (bg>140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg>140 in treatment condition minus % time with bg>140 in control condition.|10 days|||Difference score, trt-control (percent)||Standard Deviation|Mean
3277|NCT02336438|Secondary|Difference Score: Percent of Time Within Normal Blood Glucose Limits|Percent of time within normal blood glucose limits (bg 70-140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time within normal limits in treatment condition minus % time within normal limits in control condition.|10 days|||Difference score, trt-control (percent)||Standard Deviation|Mean
3278|NCT02336438|Primary|Difference Score: Percent of Time Spent in Hypoglycemic State|Percent of time within hypoglycemic blood glucose range (bg<70) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg<70 in treatment condition minus % time with bg<70 in control condition.|10 days|||Difference score, trt-control (percent)||Standard Deviation|Mean
3279|NCT02335710|Primary|Kinematics During Ramp Down Activity|AR of the femur during ramp down activity|3 months post-operative|||degrees||Standard Deviation|Mean
3280|NCT02335710|Primary|Kinematics Translations During Ramp Down Activity|AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity|3 months post-operative|||mm||Standard Deviation|Mean
3281|NCT02335710|Primary|Kinematics During Ramp up Activity|AR of the femur during Ramp Up activity|3 months post-operative|||degrees||Standard Deviation|Mean
3284|NCT02335710|Primary|Kinematics Translations During Squat to Stand (S2S) Activity|Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S|3 months post-operative|||mm||Standard Deviation|Mean
3285|NCT02335710|Primary|Kinematics During Deep Knee Bend (DKB) Activity|Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB|3 months post-operative|||degrees||Standard Deviation|Mean
3286|NCT02335710|Primary|Kinematics Translations During Deep Knee Bend (DKB) Activity|Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB|3 months post-operative|||mm||Standard Deviation|Mean
3287|NCT02334982|Secondary|Renal Clearance (CLr) for TAK-137|CLr is a measure of apparent clearance of the drug from the urine, calculated as CLr=Ae(0-t)/AUC(0-96).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||liters/hour||Standard Deviation|Mean
3288|NCT02334982|Secondary|Fraction of TAK-137 Excreted in Urine (Fe)|Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||percent excreted||Standard Deviation|Mean
3289|NCT02334982|Secondary|Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t])|Total amount of drug excreted in urine from time 0 to time t, calculated as Sum (Cu*Vu), where Cu is the concentration of drug excreted in urine and Vu is the volume of urine excreted.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||mg||Standard Deviation|Mean
3290|NCT02334982|Secondary|Apparent Volume of Distribution (Vz/F) for TAK-137_101|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||liters||Standard Deviation|Mean
3291|NCT02334982|Secondary|Apparent Clearance (CL/F) for TAK-137_101|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-inf), expressed in liters per hour (L/hr).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||liters/hour||Standard Deviation|Mean
3292|NCT02334982|Secondary|Terminal Elimination Half-life (T1/2) for TAK-137_101|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||hours||Standard Deviation|Mean
3293|NCT02334982|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||ng*hr/mL||Standard Deviation|Mean
3294|NCT02334982|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||ng*hr/mL||Standard Deviation|Mean
3295|NCT02334982|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||hours||Full Range|Median
3296|NCT02334982|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.||ng/mL||Standard Deviation|Mean
3297|NCT02334982|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|Day 1 to 14 days after the last dose of study medication|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.||percentage of participants|||Number
3298|NCT02334982|Primary|Percentage of Participants With Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|Day 1 to 14 days after the last dose of study medication (Up to 30 Days)|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.||percentage of participants|||Number
3299|NCT02334982|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to 14 days after the last dose of study medication(Up to 30 days)|Safety population included all participants who received at least one dose of study medication. 8 of the 47 enrolled participants participated in Cohort 4 fed.||percentage of participants|||Number
3324|NCT02331589|Secondary|Pro-inflammatory Cytokine|tumor necrosis factor-alpha, interleukin-6|3 weeks of KRG|||pg/mL||Standard Deviation|Mean
3300|NCT02334787|Secondary|AUC12h of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14|||ng･h/mL||Standard Deviation|Mean
3301|NCT02334787|Secondary|AUC12h of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs|||ng･h/mL||Standard Deviation|Mean
3302|NCT02334787|Primary|Cmax of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14|||ng/mL||Standard Deviation|Mean
3303|NCT02334787|Primary|Cmax of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the Cmax of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr|||ng/mL||Standard Deviation|Mean
3304|NCT02332798|Primary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3305|NCT02332798|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3306|NCT02332798|Primary|Number of Participants With Abnormalities in Physical Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3307|NCT02332798|Primary|Number of Participants With Abnormalities in Neurological Examination|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3308|NCT02332798|Primary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, and QTc using Fridericia’s formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and and QTcF >=450 to <480, 480 to <500 and >=500 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3309|NCT02332798|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<) 40 or greater than (>) 120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3310|NCT02332798|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were reported: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, phosphorus, cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), bicarbonate, uric acid, albumin, and total protein); urinalysis (color, appearance, specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.||participants|||Number
3311|NCT02332798|Primary|Peak-to-Trough Ratio at Steady State (PTR)|PTR was calculated as Cmax divided by Cmin (that is defined as lowest concentration observed during the dosing interval). PTR steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Ratio||Geometric Coefficient of Variation|Geometric Mean
3312|NCT02332798|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax) (Steady State)|Accumulation ratio based on Cmax was calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose. Rac, Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Ratio||Geometric Coefficient of Variation|Geometric Mean
3313|NCT02332798|Primary|Observed Accumulation Ratio (Rac) (Steady State)|Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1). Rac steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 (ie. X = 14) were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Ratio||Geometric Coefficient of Variation|Geometric Mean
3314|NCT02332798|Primary|Terminal Half-Life (t1/2) (Steady State)|Terminal half-life is the time measured for the plasma concentration to decrease by one half. t1/2 steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||hours||Standard Deviation|Mean
3315|NCT02332798|Primary|Apparent Volume of Distribution (Vz/F) (Steady State)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
3316|NCT02332798|Primary|Apparent Oral Clearance (CL/F) (Steady State)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
3317|NCT02332798|Primary|AUCτ (Steady State)|AUCτ steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
3318|NCT02332798|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
3319|NCT02332798|Primary|Tmax (Steady State)|Tmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||hours||Full Range|Median
3320|NCT02332798|Primary|Time for Cmax (Tmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.||hours||Full Range|Median
3321|NCT02332798|Primary|Cmax (Steady State)|Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3322|NCT02332798|Primary|Maximum Observed Plasma Concentration (Cmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The pharmacokinetic (PK) concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
3325|NCT02331589|Secondary|Fatigue as Measured by KRUPP’s Fatigue Severity Scale|"KRUPP’s fatigue severity scale.~The survey has nine questions as following:~my motivation is lower, when I am fatigued~exercise brings on my fatigue~I am easily fatigued~fatigue interferes with my physical functioning~fatigue causes frequent problems for me~my fatigue prevents sustained physical functioning~fatigue interferes with carrying out certain duties and responsibilities~fatigue is among my 3 most disabling symptoms~fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree).~Scores range from 9 to 63, with higher scores indicating higher fatigue"|3 weeks of KRG|||scores on a scale||Standard Deviation|Mean
3326|NCT02331589|Primary|Liver Enzymes|aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase|3 weeks of KRG|||U/L||Standard Deviation|Mean
3327|NCT02331446|Primary|Change in Superoxide Dismutase Activity||Weeks 0, 6 and 12|||U/mg protein||Standard Deviation|Mean
3328|NCT02331446|Other Pre-specified|Chronic Use of Medication|Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||participants|||Number
3329|NCT02331446|Other Pre-specified|Age|The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||years||Inter-Quartile Range|Median
3330|NCT02331446|Other Pre-specified|Household Income|Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||US$||Inter-Quartile Range|Median
3331|NCT02331446|Other Pre-specified|Educational Level|Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0|||participants|||Number
3332|NCT02331446|Other Pre-specified|Change in Calories Intake|Measured by a 24-hour food recall and quantified in calories|Weeks 0 and 12|||cal||Standard Deviation|Mean
3333|NCT02331446|Other Pre-specified|Change in Minutes Per Week of Physical Activity Out of Intervention|Measured by the commuting and leisure sections of the International Physical Activity Questionnaire|Week 0 and 12|||minutes per week||Inter-Quartile Range|Median
3334|NCT02331446|Other Pre-specified|Change in Body Mass Index||Weeks 0 and 12|||kg/m²||Inter-Quartile Range|Median
3335|NCT02331446|Secondary|Change in Handgrip Strength|Measured using a handgrip dynamometer and quantified in kilogram-force|Weeks 0 and 12|||kgf||Standard Deviation|Mean
3336|NCT02331446|Secondary|Change in Performance in the Six-minute Walk Test||Weeks 0 and 12|||Meters||Standard Deviation|Mean
3337|NCT02331446|Primary|Change in Glutathione Peroxidase Activity||Weeks 0, 6 and 12|||U/mg protein||Standard Deviation|Mean
3338|NCT02331446|Primary|Change in Total Thiol Content||Weeks 0, 6 and 12|||nmol TNB/mg protein||Standard Deviation|Mean
3339|NCT02331446|Primary|Change in Thiobarbituric Acid Reactive Substances||Weeks 0, 6 and 12|||nmol TBARS/mg protein||Standard Deviation|Mean
3340|NCT02331446|Primary|Change in Butyrylcholinesterase Activity||Weeks 0, 6 and 12|||µmol BuSCh/h/mg of protein||Standard Deviation|Mean
3341|NCT02331446|Primary|Change in Adenosine Deaminase Activity||Weeks 0, 6 and 12|||U/L||Standard Deviation|Mean
3342|NCT02331446|Primary|Change in Interleukin-6||Weeks 0, 6 and 12|||pg/mL||Inter-Quartile Range|Median
3343|NCT02330523|Secondary|Wound Closure at 4-weeks|Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.|4-weeks|||mm||Standard Deviation|Median
3344|NCT02330523|Secondary|New Bone Plus Graft Content at 6-months|"New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the new healing area."|Six Months|||percentage of total area||Standard Deviation|Mean
3345|NCT02330523|Primary|Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months|The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.|Six Months|||mm||Standard Deviation|Mean
3346|NCT02329964|Secondary|Time to Eye Opening|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.|from end of surgery to opening of the eyes to verbal commands|||seconds||Inter-Quartile Range|Median
3347|NCT02329964|Secondary|Time to First Spontaneous Breath|time from end of surgery to first spontaneous breaths|from end of surgery to first spontaneous breaths|||seconds||Inter-Quartile Range|Median
3348|NCT02329964|Primary|Recovery of T1 to 10%|we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes|||seconds||Inter-Quartile Range|Median
3349|NCT02329964|Other Pre-specified|Anesthesia Time|time from propofol injection to extubation|from the anesthesia start to end|||minutes||Standard Deviation|Mean
4461|NCT02259400|Primary|Duration of NIV Support|DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT|10 days|||HOURS||Inter-Quartile Range|Median
3350|NCT02329964|Other Pre-specified|Length of Stay in te Operating Room|LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.|time from in to out of the operating room|||minutes||Standard Deviation|Mean
3351|NCT02329964|Secondary|Time to Extubation|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation|from the end of surgery to extubate a tracheal tube|||seconds||Inter-Quartile Range|Median
3352|NCT02329964|Primary|Addition of Neuromuscular Blocking Agents|"Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed.~In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery.~We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery"|during surgery|||participants|||Number
3353|NCT02329964|Primary|Surgical Rating Score|"describe by surgeon under his subjective opinion.~1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions"|during surgery|||score||Inter-Quartile Range|Median
3354|NCT02329964|Primary|Recovery of T1 to 90%|we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes|||seconds||Inter-Quartile Range|Median
3355|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .||participants|||Number
3356|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .||participants|||Number
3357|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|72 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .||participants|||Number
3358|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.~The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10"|72 hours after intradermal injection|||participants|||Number
3359|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10.||participants|||Number
3360|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .||participants|||Number
3361|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|24 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .||participants|||Number
3362|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours before injection with drug.The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in in TB participants.|144 hours after injection|||participants|||Number
3584|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|one hour postoperatively|||units on a scale||Standard Deviation|Mean
3363|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours after injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|144 hours after injection|||participants|||Number
3364|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 72 hours after injection with drug.The percentage of positive(positivenumber/total number*100%) is the sensitivity of IFN-γ in in TB participants.|72 hours after injection|||participants|||Number
3365|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|72 hours after injection|||participants|||Number
3366|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug. The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in TB Participants.|4 hours before injection and after signed ICF(informed consent forms)|||participants|||Number
3367|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|before injection and after signed ICF(informed consent forms)|||participants|||Number
3368|NCT02329730|Secondary|the Number of Participants With Adverse Events|"evaluate specific time point of vital signs, skin test reaction, blood routine, urine routine, liver and kidney function, electrocardiogram and adverse events as the incidence of adverse events in the participants .~Skin test reaction observation time: at the end of the skin test, skin test after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours; Vital signs evaluation time: 0 minutes before the subjects were intradermal injection, intradermal injection after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours, 144 hours.~Blood routine, urine routine, liver and kidney function, electrocardiogram (ecg) evaluation time: skin test before and 144 h after injection; adverse events evaluation time: participants signed a written informed consent to finish all the follow-up."|before injection to 144 hours (plus or minus 2 hours) after injection|||participants|||Number
3369|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.~The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 ."|24 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .||participants|||Number
3370|NCT02329600|Secondary|Salivary Total Oxidative Capacity|total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment|one month after treatment|||umol/L||Standard Deviation|Mean
3371|NCT02329600|Primary|Pain|pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment|one month after treatment|||units on a scale||Standard Deviation|Mean
3372|NCT02329223|Secondary|Percentage of Participants With Production of Anti-omalizumab Antibody|Serum samples were collected for anti-omalizumab antibody testing.|Week 24|The safety analysis set, which included all participants who received their assigned study treatment, were considered for the analysis. Only participants, who had antibody results (conclusive or inconclusive), were analyzed.||Percentage of participants|||Number
3373|NCT02329223|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement.|Baseline to Week 12|Only participants from the FAS, who were greater than age 16, were analyzed. The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
3374|NCT02329223|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|Complete responders are defined as participants who achieved UAS7 = 0.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Percentage of participants|||Number
3375|NCT02329223|Secondary|Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12|Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Percentage of participants|||Number
3376|NCT02329223|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
3377|NCT02329223|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Percentage of participants|||Number
3378|NCT02329223|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
3379|NCT02329223|Secondary|Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
3380|NCT02329223|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria(CSU) and received the assigned study treatment.||Units on a scale||Standard Error|Least Squares Mean
3381|NCT02329015|Other Pre-specified|Teacher Report Behavior Rating Inventory of Executive Function|Teacher reported 87 item questionnaire on students executive function and self regulation. The BRIEF for teachers measures 8 non-overlapping theoretically and empirically derived clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|One year|3 subjects missing from experimental group and 5 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
3382|NCT02329015|Other Pre-specified|Student Self-Report Behavior Rating Inventory of Executive Function|An 80 item self-report questionnaire assessing executive function and self regulation. The BRIEF-SR measures 8 non-overlapping clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis. Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|1 year|9 subjects missing from experimental group and 9 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
3383|NCT02329015|Other Pre-specified|Self Report Questionnaire (Child and Adolescent Mindfulness Measure)|A 10 item self-report measure assessing mindfulness skills (Scale 1-4). Items are reverse scored and summed (not mean). Higher scores mean more positive mindfulness skills. Min and maximum scores are 0-40.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
3384|NCT02329015|Secondary|Warwick Edinburgh Mental Well Being Scale|A 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group||units on a scale||Standard Deviation|Mean
3405|NCT02325856|Secondary|Complications During DW Adjustment|we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator).|1 year|||% of months in which compli|Participants||Number
3406|NCT02325856|Primary|All-cause Hospitalization||1 year|||hospitalizations per patient-year||95% Confidence Interval|Number
3385|NCT02329015|Secondary|Response to Stress Questionnaire (RSQ)|A 57-item self-report questionnaire that was used as a measure of emotional regulation We examined two of the five constructs (24 of the 57 items) within the RSQ as these were most directly theoretically relevant to expected changes due to yoga practice: voluntary engagement and involuntary engagement. Higher values represent higher levels of negative stress responses. Values for the voluntary engagement subscale represent the mean value across 9 questions on the survey and values for the involuntary subscale represent the mean value across 15 questions on the survey. Values for each item range from 0-3, trherefore the total mean values reported as outcomes range from 0-3.|1 year|Missing data: 2 from experimental group, none from control group||units on a scale||Standard Deviation|Mean
3386|NCT02329015|Primary|Academic Performance: Grade Point Averages|GPA was calculated as the numeric average of course scores of all courses taken by the student weighted by credit load of each course using a standard process within NYC public schools.|1 year|Intent to treat analysis. Data from all participants was available at baseline and at end of study.||per cent||Standard Deviation|Mean
3387|NCT02328937|Secondary|Limbal Redness|Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.|6-8 hours post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of this study.||units on a scale||Standard Deviation|Mean
3388|NCT02328937|Primary|Central Corneal Swelling|Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.|6-8 Hours Post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of the study.||um||Standard Deviation|Mean
3389|NCT02328404|Primary|Sex Hormone Binding Globulin Concentration|"Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms.~One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration.~In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||nmol/L||Standard Deviation|Mean
3390|NCT02328404|Primary|Free Androgen Index|"Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG).~In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index.~One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||Ratio||Standard Deviation|Mean
3391|NCT02328404|Primary|Total Testosterone Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment.~In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol.~One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms.~the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||nmol/L||Standard Deviation|Mean
3392|NCT02328404|Primary|Serum Progesterone Level|"The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms.~The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level.~One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||nmol/L||Standard Error|Mean
3393|NCT02328404|Secondary|Serum C-Reactive Protien Concentration|"Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment.~In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||mg/L||Standard Error|Mean
3394|NCT02328404|Primary|Hirsutism Score|"The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth).~In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms."|3 months|||units on a scale||Standard Error|Mean
3585|NCT02313766|Secondary|Discomfort of the Preoxygenation Phase Self Reported by the Patient|discomfort of the preoxygenation phase evaluated on a visual analogue scale (0 no discomfort - 100 maximal discomfort) just before PACU leaving|Before PACU leaving|||millimeters||Inter-Quartile Range|Median
3395|NCT02328404|Secondary|Serum Phosphorous Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||mmol/L||Standard Error|Mean
3396|NCT02328404|Secondary|Serum Calcium Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||mmol/L||Standard Error|Mean
3397|NCT02328404|Primary|Menstrual Regularity|"Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level > 4 ng/mL.~One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity.~In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol.~The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||participants|||Number
3398|NCT02328404|Secondary|Serum Parathyroid Hormone Concentration|"Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period.~In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months|||Pg/ml||Standard Error|Mean
3399|NCT02328404|Secondary|Body Mass Index|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be <25-30 kg/m^2.~Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms.~In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months)."|3 months|||kg/m^2||Standard Error|Mean
3400|NCT02328404|Secondary|Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame.~In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI)."|3 months|||mmol/L||Standard Error|Mean
3401|NCT02328404|Secondary|Serum Chromium Concentration|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be > 0.05 and < 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3.~In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months|||ppm||Standard Error|Mean
3402|NCT02328404|Secondary|Serum 25-Hydroxy Vitamin D3 Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D > 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment .~In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms."|3 months|||ng/ml||Standard Error|Mean
3403|NCT02328404|Primary|Ultrasound Examination of Number of Follicles and Ovarian Volume|"Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination.~In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic.~An improvement in PCOS prognosis clinically by ultrasound examination is defined by:~decreasing the number of follicles to < 12 follicles measuring 2-9 mm in diameter~decreasing ovarian volume to < 10 cm3"|3 months|The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value</= 0.05)||participants|||Number
3404|NCT02327117|Primary|Hb Level 48 Hours After Total Knee Arthroplasty||48 hours after TKA|||gr/dL||Standard Deviation|Mean
3407|NCT02325518|Secondary|Least Squares Mean Change From Baseline in IOP at 9 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 9 AM|Per Protocol Set (PPS)||mmHg||95% Confidence Interval|Least Squares Mean
3408|NCT02325518|Primary|Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 11 AM|This analysis population includes all subjects who received study medication and met inclusion/exclusion criteria prior to randomization (Per Protocol Set).||mmHg||95% Confidence Interval|Least Squares Mean
3409|NCT02322788|Primary|Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)||4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods|Efficacy analysis set||mg/mL||95% Confidence Interval|Least Squares Mean
3410|NCT02322775|Secondary|Peripheral Blood Eosinophil Levels|"Peripheral blood eosinophil levels assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit.~Changes at Week 12 (respectively at Week 20) were calculated based on patients with both baseline and Week 12 (respectively Week 20)."|Baseline, Week 12 and Week 20|The safety analysis set comprised all patients who received at least one dose of IP. Patients were classified according to the treatment they actually received. A patient who has on one or several occasions received active treatment was classified as active.||Cells/µL||Full Range|Median
3411|NCT02322775|Secondary|Serum Concentrations (ng/mL)|Blood samples (processed to serum) for pharmacokinetic assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit. Serum concentrations of benralizumab were determined using a validated electrochemiluminescent (ECL) immunoassay.|Baseline, Week 12 and Week 20|The pharmacokinetic (PK) analysis set comprised all patients who received benralizumab and from whom PK blood samples were obtained are assumed not to be affected by factors such as protocol violations. Those patients who had at least 1 quantifiable serum PK observation post first dose were included in the PK analysis dataset.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3412|NCT02322775|Secondary|Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12|"The asthma quality of life questionnaire for 12 years and older, AQLQ(S)+12, consists of 32 questions; all assessed on a 7-point scale from 7 to 1, where 7 represents no impairment and 1 represents severe impairment. The 4 individual domain scores (symptoms, activity limitations, emotional function, and environmental stimuli) are the means of the responses to the questions in each of the domains. The overall score is calculated as the mean response to all questions. The changes from baseline of AQLQ(S)+12 score are compared between benralizumab 30 mg Q4W and placebo by using the analyse of covariance (ANCOVA) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL) and region (Europe or North America) as fixed effects and baseline AQLQ(S)+12 score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Scores on a scale||Standard Deviation|Mean
3413|NCT02322775|Secondary|Asthma Exacerbations|An asthma exacerbation was defined as a worsening of asthma that led to use of systemic corticosteroids for at least 3 days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids) or an emergency room or urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above) or an inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. Number of patients experiencing an event included in the definition of asthma exacerbation was presented.|Up to Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Patients per number of exacerbations|||Number
3414|NCT02322775|Secondary|Change From Baseline in Mean ACQ-6 Score at Week 12|"The asthma control questionnaire, ACQ-6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions. The changes from baseline of ACQ-6 score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline ACQ-6 score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Scores on a scale||Standard Deviation|Mean
3415|NCT02322775|Secondary|Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12|"Nocturnal awakenings due to asthma symptoms and requiring rescue medication use was recorded by the patient in the asthma daily diary each morning. Proportion of nights with nocturnal awakenings was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data for awakening due to asthma. The outcome variable for proportion of nights with nocturnal awakenings was the change from baseline at Week 12 in weekly proportion of nights with nocturnal awakenings. The changes are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline proportion of nights with nocturnal awakenings as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Proportion of nights||Standard Deviation|Mean
3416|NCT02322775|Secondary|Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12|"The number of rescue medication inhalations and nebulizer treatments taken were recorded by the patient in the asthma daily diary twice daily. The number of inhalations (puffs) per day was calculated as [number of night inhaler puffs] + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times]. The changes from baseline in weekly total asthma rescue medication use (puffs) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma rescue medication use (puffs) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Puffs per day||Standard Deviation|Mean
3417|NCT02322775|Secondary|Change From Baseline in Total Asthma Symptom Score at Week 12|"Asthma symptoms were recorded by the patient each morning and evening in the asthma daily diary. Symptoms were recorded using a scale of 0-3, where 0 indicates no asthma symptoms. The daily asthma symptom total score was calculated by taking the sum of the daytime score recorded in the evening and the nighttime score recorded the following morning. The weekly total asthma score was averaged from the daily scores over a 7 day period, with score ranging from 0 to 6, where 0 indicates no asthma symptoms. The changes from baseline of weekly total asthma score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Scores on a scale||Standard Deviation|Mean
3418|NCT02322775|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of evening PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline evening PEF (L/min) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||L/min||Standard Deviation|Mean
3419|NCT02322775|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of morning PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline morning PEF (L/min) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||L/min||Standard Deviation|Mean
3420|NCT02322775|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12|"The FEV1 (L) change from baseline are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) analysis with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline pre-bronchodilator FEV1 (L) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.||Litre||Standard Deviation|Mean
3421|NCT02322749|Secondary|The PK of N-desmethyl Selumetinib by Assessment of the AUC(0-t)|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the AUC(0-t) of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
3422|NCT02322749|Secondary|The PK of the Metabolite N-desmethyl Selumetinib by Assessment of Cmax|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the Cmax of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3468|NCT02319148|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
3423|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC[0-t] of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
3424|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The relative bioavailability of the TPGS capsules variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
3425|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the Cmax of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3426|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
3427|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||ng * hour per mL (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
3428|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the maximum observed plasma concentration (Cmax) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The Pharmacokinetic (PK) analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.||nanograms per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
3429|NCT02322528|Primary|Visual Quality|Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.|baseline, 30 minutes, week 1, week 2|||microns||Standard Deviation|Mean
3430|NCT02322528|Primary|Ocular Surface Temperature of Both Eyes|Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.|baseline, 30 minutes, week 1, week 2|||degrees celcius||Standard Deviation|Mean
3431|NCT02322216|Primary|Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14|Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.|Baseline, Day 14|Per Protocol Set with non-missing data||units on a scale||Standard Error|Mean
3432|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 8|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 8|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.||units on a scale||Standard Deviation|Mean
3433|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 1|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 1|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.||units on a scale||Standard Deviation|Mean
3586|NCT02313766|Secondary|Time Until SpO2=93%|time until SpO2=93% after endotracheal tube placement has been confirmed|up to 10 min|||seconds||Inter-Quartile Range|Median
3434|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and one minute after investigational product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation at one minute after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to one minute after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.||units on a scale||Standard Deviation|Mean
3435|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and immediately after product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation immediately after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to immediately after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.||units on a scale||Standard Deviation|Mean
3436|NCT02320396|Secondary|Percentage of Participants With Impression Assessments of “Better” or “Much Better” as Assessed Participants at Week 2|The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The percentage of participants with assessments of “Better” and “Much better” graded by the participant (Participant’s Impression Rate) was reported and analyzed using Odds Ratio analysis.|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.||percentage of participants|||Number
3437|NCT02320396|Secondary|Percentage of Participants With Impression Assessments of “Better” or “Much Better” as Assessed by the Investigator at Week 2|The investigator assessed the participant’s symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant’s symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The evaluation result and reason for judgment (if needed) was recorded in the participant’s case report form. The investigator’s impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant’s own impression at Week 2. The percentage of participants with assessments of “Better” and “Much better” graded by the investigator (Investigator’s Impression Rate) was reported and analyzed using Odds Ratio analysis.|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.||percentage of participants|||Number
3438|NCT02320396|Secondary|Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy|Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible. Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3439|NCT02320396|Secondary|Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3446|NCT02320396|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.|Up to 2 weeks|APaT; all participants who received ≥1 dose of study treatment.||participants|||Number
41436|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 12 months|||mmHg||Standard Deviation|Mean
3440|NCT02320396|Secondary|Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 8 to 13 (Week 2) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3441|NCT02320396|Secondary|Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3442|NCT02320396|Secondary|Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3443|NCT02320396|Secondary|Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3444|NCT02320396|Secondary|Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3445|NCT02320396|Secondary|Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment|The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant’s diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.||units on a scale||95% Confidence Interval|Least Squares Mean
3548|NCT02316613|Secondary|Number of Participants Who Used MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||participants|||Number
3447|NCT02320396|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|All Participants as Treated (APaT); all participants who received ≥1 dose of study treatment.||participants|||Number
3448|NCT02320396|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy|The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant’s diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The Full Analysis Set (FAS); all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation (average score of 2 weeks).||units on a scale||95% Confidence Interval|Least Squares Mean
3449|NCT02320227|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 days|||participants|||Number
3450|NCT02320227|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed local erythema by OB/GYN examination.|14 Days|||participants|||Number
3451|NCT02320214|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 Days|female only||participants|||Number
3452|NCT02320214|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed erythema by OB/GYN examination.|14 Days|female only||participants|||Number
3453|NCT02319525|Secondary|Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication|This was done by analyzing the audio-recorded patient-physician discussion in patients with current lupus nephritis flare. The APCC is a validated instrument to measure ‘active patient participation.’ APCC assesses indicators and facilitators of patient participation. The unit of coding is the utterance, the oral analogue of a sentence. The range is 0 to unlimited. Patient participation is measured by the number of questions, number of concerns expressed, and act of assertiveness (e.g., preferences, introducing topics, making requests). These are ‘active’ forms of participation because of their influence on clinician behavior and the structure and content of the consultation. The APPC also assess clinician behaviors that facilitate and support patient participation, partnership-building and supportive talk (e.g., reassurance, empathy). We present doctor patient-centered communication. higher scores indicates better patient participation and communication.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication, who also agreed for an audio-recorded conversation.||units on a scale||Standard Deviation|Mean
3454|NCT02319525|Secondary|Patient Physician Communication (Interpersonal Processes of Care (IPC)|This was assessed using the interpersonal processes of care (IPC), an 18-item validated patient-reported measure of patient-physician communication and care processes. The score ranges from 18 (worst) to 90 (best) and the scale is a patient-reported measure of patient-physician communication and care processes.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.||units on a scale||Standard Deviation|Mean
3455|NCT02319525|Secondary|Control Preferences Scale: Patient Participation in Decision-making|This scale assessed how much decision-making control they would like to have versus actually experienced. There are 5 responses for 5 control options: active, active shared, collaborative, passive shared and passive, which were collapsed into active (active, active shared), collaborative, and passive (passive shared and passive), as previously (and pre-specified). Concordance was assessed between desired and actual role played by each patient. We present these data for patients with current flare only, since only they were making a decision about the immunosuppressive drugs; patients with past lupus flare were not included in the denominator.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication.||participants|||Number
3456|NCT02319525|Primary|Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)|Concordance between values related (for or against starting) immunosuppressive drugs with patients’ decision (to start or not start) immunosuppressive drugs, in those with adequate knowledge about benefits/harms of immunosuppressive drugs, assessed using validated instruments for values regarding immunosuppressive drugs, knowledge about immunosuppressive drugs, and treatment decision-making (patient’s decision to start immunosuppressive drug).|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.||participants|||Number
3587|NCT02313766|Primary|Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%|Time measured form face mask positioning until FEO2 reached 90% on the gas monitor|up to 5 min|||seconds||Inter-Quartile Range|Median
41437|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 24 months|||mmHg||Standard Deviation|Mean
3457|NCT02319525|Primary|Change From Baseline in Decisional Conflict Scale Scores|Patient self-administered, validated measure of decisional conflict, most commonly used as the primary outcome in RCTs of decision aids (change score). The score ranges from 0 (no decisional conflict) to 100 (extreme decisional conflict). Decisional conflict represents a state of uncertainty about a choice or course of action and is more likely in situations involving high-stakes choices with important potential gains and losses, value tradeoffs in selecting a choice or a course of action (vs. the alternative) or uncertain outcomes.|Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet||units on a scale||Standard Deviation|Mean
3458|NCT02319486|Primary|Event Free Survival Rate|measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis|18 months|||participants|||Number
3459|NCT02319148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.||participants|||Number
3460|NCT02319148|Secondary|Number of Participants Who Used at Least 1 Concomitant Medication|Participants were to abstain from all concomitant treatments, except for the treatment of AEs. Treatments taken after the first dose of study treatment were documented as concomitant treatments.|Baseline up to Day 15 (final study evaluation)|The safety analysis population included all participants who received the study medication.||participants|||Number
3461|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.||participants|||Number
3462|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to Day 9|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.||participants|||Number
3463|NCT02319148|Secondary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.||participants|||Number
3464|NCT02319148|Secondary|Terminal Elimination Half-Life (t1/2) of PF-00489791|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hour||Standard Deviation|Mean
3465|NCT02319148|Secondary|Apparent Oral Clearance (CL/F) of PF-00489791|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
3466|NCT02319148|Secondary|Apparent Volume of Distribution (Vz/F) of PF-00489791|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||liter||Geometric Coefficient of Variation|Geometric Mean
3467|NCT02319148|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hour||Full Range|Median
5259|NCT02217878|Primary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)||prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose|||ng*h/mL||Standard Deviation|Mean
3469|NCT02319148|Primary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
3470|NCT02319148|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The pharmacokinetic (PK) analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
3471|NCT02319031|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities|Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.|Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)|All treated participants: Enrolled participants who received at least 1 dose of study drug||participants|||Number
3472|NCT02319031|Secondary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)|SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Weeks 4 and 24|All treated participants: Enrolled participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
3473|NCT02319031|Primary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)|SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Week 12|All treated participants: Enrolled participants who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
3474|NCT02318940|Secondary|Arterial Puncture|Arterial puncture aspiration involves pulsatile arterial blood|intraoperative|||percentage|||Number
3475|NCT02318940|Secondary|Number of Attempts|considered attempt the passage of the needle without removing or redirect moving forward. Each successive removal or redirection with a forward motion is considered more a try|intraoperative||||||
3476|NCT02318940|Secondary|Successful Installation|is considered successful installation when the guide is installed without difficulty in femoral vein|intraoperative|||percentage|||Number
3477|NCT02318940|Primary|Installation on the First Try|Is considered successful when installing the CVC is accomplished by first transcutaneous passage to the glass needle|intraoperative|||percentage|||Number
3478|NCT02318693|Secondary|Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)|Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose <70, <60, <50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||Percent change||95% Confidence Interval|Least Squares Mean
3479|NCT02318693|Secondary|Change From Baseline in 24-hour Mean Glucose Level|The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
3480|NCT02318693|Secondary|Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal|The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
8494|NCT02092649|Secondary|Change in Whole Body Resting Carbohydrate Oxidation From Baseline||Baseline, 6 weeks, 12 weeks|||percent change||Standard Deviation|Mean
3481|NCT02318693|Secondary|Change From Baseline in the Standard Deviation of Blood Glucose Levels|SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
3482|NCT02318693|Primary|Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13|MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
3483|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Titers for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Data could not be collected as there were no subjects with positive results for ADAs and NAbs.|||||
3484|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Titers for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods||08/2017||||
3485|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
3486|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods.||08/2017||||
3487|NCT02317809|Secondary|Pain Visual Analogue Scale (VAS) Score|The severity of pain was evaluated by the subject and recorded using a 100 millimeter (mm) visual analogue scale (VAS) ranging from 0 to 100, where 0 mm = no pain and 100 mm = worst possible pain.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified time point in each arm, respectively.||mm||Standard Deviation|Mean
3488|NCT02317809|Secondary|Number of Subjects With Local Tolerability/Injection Site Reactions (ISRs)|Injection site was assessed by the study site staff for any local reaction (redness, swelling, bruising, and itching). Redness and bruising were scaled as None (no visible redness or bruising); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising); Severe (>5.0 cm redness or bruising). Swelling was scaled as None (no swelling detected); Mild (palpable ‘firmness’ only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Itching was scaled as None (no itching); Mild itching; Moderate itching and Severe itching. Only those scale categories which report at least 1 subject were presented.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified injection site reaction at the specified time point for each arm, respectively.||Subjects|||Number
3489|NCT02317809|Secondary|Serum Estradiol Levels|Data was planned to be presented as per the sequence of treatment received.|Screening (up to 28 days), Day 1 (pre-dose) and Day 8 in Period 1, Day 1 (pre-dose), Day 8 and follow-up (Day 18) in Period 2|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||nanogram per liter (ng/L)||Standard Deviation|Mean
3490|NCT02317809|Secondary|Number of Subjects With Follicle Size Greater Than (>)13 Millimeter|Transvaginal ultrasound (TVUS) was performed to determine the follicle size and number.|Day 1 (pre-dose) up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
3491|NCT02317809|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Laboratory Assessments, Vital Signs or Electrocardiogram Findings||Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
3492|NCT02317809|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a subject, regardless of causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs and non-serious AEs.|Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).||Subjects|||Number
3493|NCT02317809|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration. Apparent volume of distribution (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
3494|NCT02317809|Secondary|Apparent Serum Clearance (CL/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained is influenced by the fraction of the dose absorbed and was expressed as volume (Liter) per unit of time (hour).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
3495|NCT02317809|Secondary|Apparent Terminal Half-life (t1/2) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Terminal half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
3496|NCT02317809|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||Hour (h)||Full Range|Median
3497|NCT02317809|Secondary|Apparent Terminal Elimination Rate Constant (Lambda[z]) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|The elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||Per Hour (1/hour)||Geometric Coefficient of Variation|Geometric Mean
3498|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time Tlast Extrapolated to Infinity (%AUCextra,Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Area under the serum concentration-time curve from Tlast extrapolated to infinity given as a percentage of AUC0-inf. Data was not planned to be summarized if AUCextra,adj was less than 20%.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|As per statistical analysis plan, data was not planned to be summarized because AUCextra,adj was below 20% for all the participants.|||||
3499|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC0-inf, Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
3500|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Luteinizing Hormone (LH)|Baseline-corrected Cmax (Cmax,adj) = Cmax – baseline concentration.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
3501|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Follicle-Stimulating Hormone (FSH)|Baseline-corrected Cmax (Cmax,adj) = Cmax – baseline concentration|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
3502|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-t,Adj) for Luteinizing Hormone (LH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t – (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
3503|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC 0-t,Adj) for Follicle-Stimulating Hormone (FSH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t – (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: All randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully down regulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
3504|NCT02317510|Secondary|Headache|Group 1 and Group 2 Headache|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old.||participants|||Number
3505|NCT02317510|Secondary|Nausea/Vomiting|Group 1 and group 2 nausea/vomiting|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old.||participants|||Number
3506|NCT02317510|Secondary|Urinary Retention|Group 1 and Group 2 Urinary retention|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old||participants|||Number
3507|NCT02317510|Secondary|Intra-operative Shoulder Pain|Group 1 and Group 2 Intra-operative shoulder pain|during operation time, up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.||participants|||Number
3508|NCT02317510|Primary|Post-operative Shoulder Pain|Group 1 and Group 2 Post-operative shoulder pain|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old||participants|||Number
3509|NCT02317510|Secondary|Post-operative Abdominal Pain 24th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 24th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
3510|NCT02317510|Secondary|Post-operative Abdominal Pain 12th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 12th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
3511|NCT02317510|Secondary|Post-operative Abdominal Pain 6th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 6th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
3512|NCT02317510|Secondary|Post-operative Abdominal Pain 4th Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 4th hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
3513|NCT02317510|Secondary|Post-operative Abdominal Pain 2nd Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 2nd hour|All patients have gall bladder disease who are between 18-90 years old.||units on a scale||Standard Deviation|Least Squares Mean
3514|NCT02317510|Secondary|Duration of Anaesthesia|Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.||minutes||Standard Deviation|Mean
3515|NCT02317510|Primary|Duration of Operation|group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.||minutes||Standard Deviation|Mean
3516|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of AUCtau (MRAUCtau) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRAUCtau for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
3517|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of Css,Max (MRCss,Max) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRCss,max for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
3518|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance at Steady State (CLss/F) for AZD9291 Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291 by assessment of CLss/F after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||L/h||Geometric Coefficient of Variation|Geometric Mean
3519|NCT02317016|Secondary|Assessment of Minimum Plasma Concentration at Steady State (Css,Min) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,min over the dosing interval. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
3520|NCT02317016|Secondary|Assessment of Time to Reach Maximum Plasma Concentration at Steady State (Tss,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of tss,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
3521|NCT02317016|Secondary|Assessment of Maximum Plasma Concentration at Steady State (Css,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
3522|NCT02317016|Secondary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUCtau) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of AUCtau. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanomolar * h (nM*h)||Geometric Coefficient of Variation|Geometric Mean
3523|NCT02317016|Secondary|Assessment of Terminal Elimination Half-life (t1/2[lambda_z]) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of t1/2(lambda_z). Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Geometric Coefficient of Variation|Geometric Mean
3524|NCT02317016|Secondary|Assessment of Apparent Volume of Distribution (Vz/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Vz/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||L||Geometric Coefficient of Variation|Geometric Mean
3525|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance (CL/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of CL/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Litre / h (L/h)||Geometric Coefficient of Variation|Geometric Mean
3526|NCT02317016|Secondary|Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration at Time “t” (AUC0-t) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of AUC0-t. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
3673|NCT02308787|Other Pre-specified|Procedure Duration||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||minutes|Participants|Standard Deviation|Mean
3527|NCT02317016|Secondary|Assessment of Time to Maximum Plasma Concentration (Tmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of tmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
3528|NCT02317016|Primary|Assessment of AUC From Time Zero Extrapolated to Infinity for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of AUC from time zero extrapolated to infinity. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng * h o u r per mL (ng*h/mL )||Geometric Coefficient of Variation|Geometric Mean
3529|NCT02317016|Primary|Assessment of Maximum Plasma Concentration (Cmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Cmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1 [Period 1] and Day 32 [Period 3], respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
3530|NCT02316769|Secondary|Time to Intubation|Number of patients intubated in less than 90 seconds|Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.|||participants|||Number
3531|NCT02316769|Primary|Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide||participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.|||participants|||Number
3532|NCT02316613|Secondary|Number and Type of Hospitalization Associated With MabThera Perfusion|Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.|Up to 6 years|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||hospitalizations|Participants||Number
3533|NCT02316613|Secondary|Function Assessment of Chronic Illness Therapy–General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score|"The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0–28; social well-being, scored 0–28; functional well-being, scored 0–28; emotional well-being, scored 0–24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, Not at all to 4, Very much). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items."|Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. n=number of evaluable questionnaires for each category.||score on scale|Participants|Standard Deviation|Mean
3534|NCT02316613|Secondary|Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase||Maintenance phase : 67.8 months|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one MabThera infusion over the maintenance therapy period. n=number of evaluable participants for each category.||percentage of participants|||Number
3535|NCT02316613|Secondary|MabThera Regimen: Time Between Cycles||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.||days||Standard Deviation|Mean
3536|NCT02316613|Secondary|MabThera Regimen: Number of Cycles of MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.||number of cycles||Standard Deviation|Mean
3537|NCT02316613|Secondary|MabThera Regimen: Infusion Duration||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.||minutes (mn)||Standard Deviation|Mean
3538|NCT02316613|Secondary|MabThera Regimen: Dose of MabThera|All participants who received MabThera treatment before the first disease progression were reported.|Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.||milligram (mg)||Standard Deviation|Mean
3549|NCT02316613|Secondary|Overall Survival (OS)|The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||months||95% Confidence Interval|Median
41438|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 18 months|||mmHg||Standard Deviation|Mean
3539|NCT02316613|Primary|Number of Participants With Therapeutic Management After the First Study Disease Progression|After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.||participants|||Number
3540|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression|The therapeutic management of participants was decided by either “pluri-disciplinary consultation meeting,” “Only the physician in charge of the participant,” “Discussion between physicians,” or “Punctual consultation of an external physician.” Percentage of participants with each of these modalities of therapeutic decision was reported.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.||percentage of participants|||Number
3541|NCT02316613|Primary|Percentage of Participants With Injection Prophylaxis Treatment|Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number participants analyzed= all participants having had maintenance/observation period before the first study disease progression and received infection prophylaxis treatment.||percentage of participants|||Number
3542|NCT02316613|Primary|Percentage of Participants With Prescription of Injection Prophylaxis|Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed=all participants having had maintenance/observation period before the first study disease progression.||percentage of participants|||Number
3543|NCT02316613|Primary|Duration of MabThera Maintenance Therapy When Associated With Observation|Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one infusion of MabThera and completed maintenance therapy with MabThera when associated with observation period.||months||Full Range|Median
3544|NCT02316613|Primary|Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase|After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one MabThera infusion over the maintenance therapy period.||percentage of participants|||Number
3545|NCT02316613|Primary|Percentage of Participants With MabThera as Maintenance Therapy|During the maintenance period participants received four weekly infusion of MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those who entered in maintenance/observation after the first induction and before the first disease progression over the study.||percentage of participants||95% Confidence Interval|Number
3546|NCT02316613|Primary|Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase|Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||percentage of participants|||Number
3547|NCT02316613|Primary|Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase|Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin’s lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||percentage of participants|||Number
8495|NCT02092649|Secondary|Change in Whole Body Resting Fat Oxidation From Baseline||Baseline, 6 weeks, 12 weeks|||percent change||Standard Deviation|Mean
3550|NCT02316613|Secondary|Time to Next Treatment|Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||months||95% Confidence Interval|Median
3551|NCT02316613|Secondary|Progression Free Survival (PFS)|The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.||months||95% Confidence Interval|Median
3552|NCT02316613|Secondary|Percentage of Participants With Disease Characteristics at First Study Disease Progression|Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. n=number of evaluable participant for each disease characteristics.||percentage of participants|||Number
3553|NCT02316613|Secondary|Percentage of Participants With Number of Disease Progressions|Participants with at least one disease progression after the first study induction period were reported.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those participants who entered in maintenance/observation after the first induction and before the first disease progression over the study.||percentage of participants|||Number
3554|NCT02316613|Secondary|Percentage of Participants With Last Induction Treatment Response|Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter’s syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed (N)=number of participants evaluable for this outcome measure.||percentage of participants|||Number
3555|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase|At study inclusion, the therapeutic management of participants was decided by either “pluri-disciplinary consultation meeting,” “Only the physician in charge of the participant,” “Discussion between physicians,” or “Punctual consultation of an external physician.” Percentage of participants with each of these modalities of therapeutic decision was reported.|Baseline|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
3556|NCT02316366|Secondary|Global Comfort|Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay|4 hours||||||
3557|NCT02316366|Secondary|Amount of Narcotic Administered|The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient|4 hours|||mg/kg||95% Confidence Interval|Mean
3558|NCT02316366|Secondary|Time to Disposition|The amount of time spent in the ED was recorded for each patient|4 hours|||minutes||95% Confidence Interval|Mean
3559|NCT02316366|Secondary|Pain Score|During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided.|4 hours||||||
3560|NCT02316366|Primary|Rate of Hospital Admission|After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.|4 hours|||percentage of participants||95% Confidence Interval|Number
3561|NCT02315989|Secondary|Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable|Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).|Average 100 days after treatment.|||percentage of participants|||Number
3563|NCT02315989|Primary|Rate and Severity of Adverse Reactions|After enrollment, each patient has to receive physical examination, laboratory tests, and image studies as baseline. During the course of radiotherapy, patients will have weekly evaluations in physicals and laboratory tests. Image studies are optional during treatment. In the follow-up periods, monthly exams, including regular physicals, markers in serum and urine and image studies to evaluation treatment responses, will be scheduled till 90 days after the end of treatment.|Average 90 days after treatment.|||participants|||Number
3564|NCT02314689|Secondary|Nitric Oxide|Unposted|2 years||12/2018||||
3565|NCT02314689|Primary|Number of Participants With Grade 2 or Higher Adverse Event According to NCI Criteria||2 years|||participants|||Number
3566|NCT02314637|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||mg/dL||Standard Deviation|Mean
3567|NCT02314637|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||percent||Standard Deviation|Mean
3568|NCT02314637|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.||participants|||Number
3569|NCT02314546|Secondary|Verbal Complaints|Recorded by the administering RN at one minute post-administration|1 minute post-administration|||participants|||Number
3570|NCT02314546|Secondary|Verbal Complaint|Recorded by the administering RN at the time of administration.|At time of administration|||participants|||Number
3571|NCT02314546|Secondary|RN Observed Behavioral Distress Score|Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration|||units on a scale||Standard Deviation|Mean
3572|NCT02314546|Secondary|Parental Observed Behavioral Distress Score|Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration|||units on a scale||Standard Deviation|Mean
3573|NCT02314546|Primary|Time From Administration to Discharge||Minutes from administration to discharge|||minutes||Standard Deviation|Mean
3574|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|15 minutes post-sedation|participants with available data at this time point||participants|||Number
3575|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|10 minutes post-sedation|participants with available data at this time point||participants|||Number
3576|NCT02314260|Secondary|Cut Off Value for Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% & specificity was 73% to failed induction||probability|||Number
3577|NCT02314260|Secondary|Cut Off Value for The Modified Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% and a specificity of 87% for failed induction.||probability|||Number
3578|NCT02314260|Secondary|Area Under Curve for The Bishop Score|to predict failed induction and comparing it to the area under curve for modified bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section. The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity), So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction of labour fails, the Y-axis of the curve is (sensitivity) and the x- axis is (1-specificity).||probability||95% Confidence Interval|Number
3579|NCT02314260|Primary|Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score|to predict failed induction and comparing it to the area under curve for bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section.The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity). So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|the area under the modified bishop score was 0.916 (95% [confidence interval ] 0.85–0.97). The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).||probability||95% Confidence Interval|Number
3580|NCT02314104|Secondary|Total Narcotic Usage in Morphine Equivalents||up to twenty-four hours postoperatively|||mg||Standard Deviation|Mean
3581|NCT02314104|Secondary|Time Until First Request for Pain Medication||up to twenty-four hours postoperatively|||minutes||Inter-Quartile Range|Median
3582|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|twenty-four hours postoperatively|Arm 1: one subject discharged prior to obtaining 24 hour pain score Arm 2: one subject discharged prior to obtaining 24 hour pain score Arm 3: four subjects discharged prior to obtaining 24 hour pain score||units on a scale||Standard Deviation|Mean
3583|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|six hours postoperatively|Arm 2: 6 hour pain score not obtained on one subject Arm 3: 6 hour pain score not obtained on one subject||units on a scale||Standard Deviation|Mean
3588|NCT02313558|Primary|Gingivitis Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
3589|NCT02313558|Primary|Plaque Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
3590|NCT02313558|Primary|Gingivitis Assessment After 6 Weeks of Dentifrice Use|After 6 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.|6 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
3591|NCT02313558|Primary|Plaque Assessment After 6 Weeks of Dentifrice Use|"After 6 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|6 weeks after dentifrice use|||units on a scale||Standard Deviation|Mean
3592|NCT02313233|Primary|Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge|The Quality of Life (QoL) is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.||units on a scale||Standard Deviation|Mean
3593|NCT02313233|Primary|International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months.||units on a scale||Standard Deviation|Mean
3594|NCT02313233|Primary|Quality- Of- Life Index (QoL)|The QoL index is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Hatnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment||units on a scale||Standard Deviation|Mean
3595|NCT02313233|Secondary|Prostate-specific Antigen (PSA) Level|Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||ng/ml||Standard Deviation|Mean
3596|NCT02313233|Secondary|Prostate Volume|It's related to progression of benign prostatic hyperplasia (BPH).|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||cm^3||Standard Deviation|Mean
3597|NCT02313233|Secondary|Postvoid Residual Volume (PVR)|The PVR urine test measures the amount of urine left in the bladder after urination.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receivingHarnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||ml||Standard Deviation|Mean
3598|NCT02313233|Secondary|Maximum Flow Rate (Qmax)|It's used to determine the degree of urinary difficulty.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment.||ml/ sec||Standard Deviation|Mean
3599|NCT02313233|Primary|International Prostate Symptom Score (IPSS)|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|For all subjects' medical histories in this study, there are one subject receiving Hatnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.||units on a scale||Standard Deviation|Mean
3600|NCT02313155|Secondary|GMT in SRH Antibody Titer (Cell Derived Antigen)|GMT in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
3601|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
3602|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3603|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with a SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3604|NCT02313155|Secondary|GMT in HI Antibody Titer (Cell Derived Antigen)|GMT in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
3605|NCT02313155|Secondary|GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
3606|NCT02313155|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline HI <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3607|NCT02313155|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40|Seroprotection rate as measured by HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with an HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3608|NCT02313155|Secondary|GMT in SRH Antibody Titer (Egg-derived Antigen)|GMT in SRH antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
3609|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (egg-derived antigen) as compared to baseline pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days after vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
3610|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3611|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) was defined as percentage of participants with an SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3674|NCT02308787|Other Pre-specified|Average Inlet Flow Rate||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||mL/min|Participants|Standard Deviation|Mean
3612|NCT02313155|Secondary|Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)|GMT in HI antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||titer||95% Confidence Interval|Geometric Mean
3613|NCT02313155|Secondary|Change From Baseline in Body Temperature|Change from baseline in body temperature (oral) was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.||degree celsius||Standard Deviation|Mean
3614|NCT02313155|Secondary|Change From Baseline in Pulse|Change from baseline in pulse was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.||beats per minute||Standard Deviation|Mean
3615|NCT02313155|Secondary|Change From Baseline in Blood Pressure|Change from baseline in systolic and diastolic blood pressure was reported|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.||millimeter mercury (mmHg)||Standard Deviation|Mean
3616|NCT02313155|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|Laboratory values included hematology, biochemistry and urinalysis tests.|Baseline,up to 21 Days after drug administration (Day 22)|Safety analysis set was defined as all participants who received vaccination with the study drug.||participants|||Number
3617|NCT02313155|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (egg-derived antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||fold increase||95% Confidence Interval|Geometric Mean
3618|NCT02313155|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3619|NCT02313155|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.|Seroprotection rate as measured by HI antibody titer (egg-derived antigen) was defined as percentage of participants with the HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.||percentage of participants||95% Confidence Interval|Number
3620|NCT02313155|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.||participants|||Number
3621|NCT02313155|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.||participants|||Number
3622|NCT02312739|Secondary|Provider Ease of Insertion (0-100mm VAS)|Physician who did the procedure will complete a 0-100mm VAS on ease of insertion of the sterilization devices with anchors 0 equals no difficulty and 100 equals very difficult.|Within 5 minutes after the Essure® procedure|||units on a scale||Standard Deviation|Mean
3623|NCT02312739|Secondary|Patient Satisfaction (5-point Likert Scale)|Patients were asked to rate their overall satisfaction with the procedure using a 5-point Likert scale (Very unsatisfied, Unsatisfied, Neutral, Satisfied, Very satisfied). Results were analyzed to portray the percentage of participants who felt satisfied at the listed interval levels.|Prior to discharge from clinic, approximately 30-45 minutes post-procedure|||percentage of participants|||Number
3624|NCT02312739|Secondary|Change From Baseline in Patient Anxiety Scale After the Procedure|Participants were asked to complete a validated short form of the Spielberger State-Trait Anxiety Inventory (STAI) at baseline and at 3-5 minutes after the in-office sterilization procedure. On the STAI scale, participants rated five statements (I feel calm, I am tense, I feel upset, I am relaxed, I am worried) on a 1 - 4 scale (Not at all, Somewhat, Moderately, Very Much, totaling in a score from 0-20 (0 being least anxious, 20 being the most anxious).|At baseline before the procedure and at 3-5 minutes after the Essure® procedure|||units on a scale||Standard Deviation|Mean
3625|NCT02312739|Primary|Pain Scale Measurement - Maximum Pain Experienced|The maximum pain that was experienced during the procedure is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at 3 to 5 minutes following completion of the procedure.|At 3-5 minutes after the procedure|||units on a scale||Standard Deviation|Mean
3626|NCT02312739|Primary|Change From Baseline in Pain Scale Measurement During and After the Procedure|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at baseline, after paracervical block injection and after placement of second Essure® coil. A final pain assessment is done prior to discharge.|At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)|||units on a scale||Standard Deviation|Mean
3627|NCT02312726|Other Pre-specified|Provider Ease-of-insertion|The provider who inserts the IUD will be asked to complete a 4-item Likert scale rating perceived difficultly of insertion: 1 = easy; 2 = somewhat easy; 3 = somewhat difficult, 4 = difficult.|Within 5 minutes following postpartum IUD insertion|||participants|||Number
3628|NCT02312726|Secondary|Pain Score: Verbal Rating Scale (VRS)|This is a 4-item ordinal pain scale which has been used for pain level assessment. When prompted, patients will be asked to indicate which level of pain most accurately represents their pain level; 0 = No pain, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery. Women who undergo a postpartum interview will be asked to perform a recal VRS pain assessment|||participants|||Number
3629|NCT02312726|Secondary|Pain Score: Visual Analog Scale (VAS)|This is a validated instrument used extensively in the assessment of acute pain. When prompted, patients will be asked to mark the continuous 100 mm VAS line at the point which most accurately represents their pain level; 0 = no pain, 100 = pain as bad as it could be.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery; women who undergo a postpartum interview will be asked to perform a recall VAS pain assessment|||units on a scale||Standard Deviation|Mean
3630|NCT02312726|Primary|Assessment of Women’s Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews|A semi-structured interview guide(available in both English and Spanish) which was developed in consultation with an expert in qualitative methodology at the UNM Clinical & Translational Science Center (CTSC), and UNMH family planning experts, will be administered to all participants. The interview will incorporate the following domains of women’s perceptions of the postplacental IUD insertion experience: decisional influence, experience during the procedure, decisional regret, prior knowledge/ awareness of the method and postpartum contraception in general. The interview will conclude with an overall patient satisfaction score measured on a five-point Likert scale: 1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, 5 = very satisfied.|Within 24-48 hours after vaginal delivery, prior to hospital discharge|21 participants (out of the 68 included in the study) consented to an interview regarding their experience. We conducted 21 interviews; 9 with women who did not have an epidural and 12 with women who had an epidural.||participants|||Number
3631|NCT02312154|Primary|Global Aesthetic Improvement Scale (Subject)|The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse|12 weeks|||scores on a scale||Standard Deviation|Mean
3632|NCT02312154|Primary|Global Aesthetic Improvement Scale (Investigator)|The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.|12 weeks|||scores on a scale||Standard Deviation|Mean
3633|NCT02312154|Primary|Erythema Index|"We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany).~The range of erythema index is 0~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) ~999 AU (most erythematous possible)"|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
3634|NCT02312154|Primary|Melanin Index|"We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany).~The range of melanin index was 0 (as bright as possible) ~999 AU (Arbitrary Unit) (most dark possible)."|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
3635|NCT02312154|Primary|Elasticity|"We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany).~The range of elasticity was 0 (most elastic possible as) ~400 AU(Arbitrary Unit) (inelastic as possible)"|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
3636|NCT02312154|Primary|Hydration Level|"We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany).~The range of hydration level was 0 (as dry as possible) ~120 AU (Arbitrary Unit)(most moist possible)"|12 weeks|||AU (arbitrary unit)||Standard Deviation|Mean
3637|NCT02311309|Secondary|Lowest Hemoglobin|lowest peroperative hemoglobin concentration|one day||||||
3638|NCT02311309|Secondary|Preoperative Anemia|proportion of patients with preoperative anemia|one day||||||
3639|NCT02311309|Secondary|Transfusions|transfusion pattern in the whole cohort|one day|||number of participants|||Number
3640|NCT02311309|Primary|Unanticipated Bleeding|From arrival in operating room until the patients leave post anesthesia care unit|one day|||percentage of participants|||Number
3641|NCT02310776|Primary|Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)|Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians|Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.|Each participant was evaluated based on Breast Imaging-Reporting and Data System (BI-RADS) assessment for Automated and Handheld breast ultrasound exams. If participant had more than one lesion, each lesion was assessed and listed separately and if a participant did not have a lesion, she was entered once.||Detection ratio of lesions|Participants|95% Confidence Interval|Number
3642|NCT02310646|Other Pre-specified|Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2|Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel)|Baseline to Week 2|In total 103 preferred foam and 105 preferred gel. 4 subjects ...||percentage of subjects|||Number
3643|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments|The VPM questionnaire was analysed the same way as the TPUQ. Numeric scores were calculated by assigning the following values to each response category: -3 = Extremely unappealing, -2 = Moderately unappealing, -1 = Slightly unappealing, 0 = Neutral, 1 = Slightly appealing, 2 = Moderately appealing, 3 = Extremely appealing. A summary score was defined as the sum of all questions and could range from -21 to 21.|At Week 1 and Week 2|||units on a scale||Standard Deviation|Mean
3675|NCT02308787|Other Pre-specified|Whole Blood Processed (mL)|Volume of patients blood processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||mL|Participants|Standard Deviation|Mean
3644|NCT02310646|Other Pre-specified|Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)|"Subjects in both arms (foam-gel; gel-foam) indicated whether they preferred latest topical treatment, LEO 90100 aerosol foam, Daivobet® gel, or did not have any preference.~The subjects compared the trial treatment used the previous week with the latest topical treatment (used within 3 months prior to baseline; CLTT analysis set). Each item was scored with either ‘prefer latest treatment’, ‘no preference’, or ‘prefer trial medication (foam or gel)’. A subject could prefer both study treatments over the latest topical treatment. The percentage is given for the number of subjects preferring foam and number of subjects preferring gel."|At Week 1 and Week 2|CLTT analysis set was defined by including all randomised subjects who had used topical anti-psoriatic medication on the treatment area (trunk and/or limbs) within 3 months prior to Baseline.||percentage of subjects|||Number
3645|NCT02310646|Other Pre-specified|Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments|"The TPUQ tool was used to evaluate the subject’s latest topical treatment at Baseline (used within 3 months prior to baseline). TPUQ assessments of trial treatments at Week 1 and Week 2.~Each response category (item 1 to 25) was assigned a numeric score from-2=strongly disagree to 2=strongly agree. For item 26 the assigned scores were from -2=very dissatisfied to 2=very satisfied.~Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6).~For each subject and each item, the latest topical treatment score was compared with each study treatment by calculating the difference between the scores, i.e., by subtracting the latest topical treatment score from each study medication score. The higher score signifies higher preference in that domain."|Baseline to Week 2|||units on a scale||Standard Deviation|Mean
3646|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments|"Each response category (item 1 to 25) was assigned a numeric score (-2=strongly disagree, -1=slightly disagree, 0=neither agree nor disagree, 1=slightly agree, 2=strongly agree). For item 26, the assigned score were from -2=very dissatisfied to 2=very satisfied.~Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). Positive scores indicate agreement with domains’ items.~A total TPUQ summary score (item 1-25; score range -50 to +50) was also calculated. The summary scores were analysed in the same way as the individual questions. The higher score signifies higher preference in that domain."|2 weeks|||units on a scale||Standard Deviation|Mean
3647|NCT02310646|Primary|Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics|"The SPA questionnaire was completed at Week 2 and consisted of 2 parts:~(i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from ‘very important factor’ to ‘not at all important factor’.~The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website."|2 weeks|||percentage of subjects|||Number
3648|NCT02310568|Secondary|Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores|Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8|Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a <50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of >= 16 at Week 4.||percentage of participants|||Number
3649|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
3650|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
3676|NCT02308787|Other Pre-specified|Patient's WBC Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||cells x 10^9/L|Participants|Standard Deviation|Mean
3651|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 2|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8|Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||ng/mL||Standard Deviation|Mean
3652|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 1|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||ng/mL||Standard Deviation|Mean
3653|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, “Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?” Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
3654|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
3655|NCT02310568|Secondary|Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2|A responder was defined as a participant with >= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
3656|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 1, 2, 3|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
3657|NCT02310568|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
3658|NCT02310568|Secondary|Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
3677|NCT02308787|Other Pre-specified|Patients WBC Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure|||cells x 10^9/L|Participants|Standard Deviation|Mean
3678|NCT02308787|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||cells x 10^3/L|Participants|Standard Deviation|Mean
3659|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 5, 6, 7, 8|Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) < 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of >=16 at Week 4. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
3660|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
3661|NCT02310568|Primary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 4|Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
3662|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (>=)16 at Week 4.||units on a scale||Standard Deviation|Mean
3663|NCT02310126|Primary|Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.|CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|15 minutes post Contact Lens Insertion|The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.||units on a scale||Standard Deviation|Mean
3664|NCT02309294|Primary|Number of Subjects That Showed no Significant Irritation|Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).|14 days|||participants|||Number
3665|NCT02309112|Secondary|Patient Adherence Rate to Yoga Intervention|% of patients who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||percentage of participants|||Number
3666|NCT02309112|Other Pre-specified|Patient's Health-related Quality of Life|Assessed via an online survey of a validated, cancer-specific survey instrument measuring health-related quality of life (QOL-CA/CS), (0 worst; 10 best possible). The QOL-CA/CS score was assessed pre and post yoga intervention.|6 weeks|Male (n=3) and female (n=9) adults undergoing conventional treatment for cancer diagnosis in Vancouver, Canada.||units on quality of life scale||Full Range|Mean
3667|NCT02309112|Other Pre-specified|Financial Cost of Delivering Yoga Intervention in a Clinical Setting|Calculation of the per participant cost of three types of yoga interventions (Group A, B and C). The financial data included cost of in-person instruction, cost of materials and time to design and implement intervention per participant in each yoga group.|10 weeks|Male (n=3) and female (n=10) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||dollars (USD)|||Number
3668|NCT02309112|Other Pre-specified|Patient Acceptability of Yoga Intervention|Amount of satisfaction for adult cancer patients assessed via Likert-scale surveys; on scale of 1 to 10, 1 being not satisfied; 10 being extremely satisfied (i.e higher number, better outcome).|6 weeks|Adult male (n=3) and female (n=9) cancer patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||units on satisfaction scale||Full Range|Mean
3669|NCT02309112|Secondary|Patient Adherence to Yoga Intervention|Number of participants who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada||participants|||Number
3670|NCT02309112|Primary|Feasibility of Patient Recruitment to Yoga Intervention|Number of participants eligible for randomization to yoga intervention during cancer treatment|10 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment in Vancouver, Canada for a cancer diagnosis; who have not participated in yoga the past month.||participants|||Number
3671|NCT02308787|Other Pre-specified|Total Blood Volume (TBV) Processed|The number of times the patient's total blood volume is processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||Number of TBVs processed|Participants|Standard Deviation|Mean
3672|NCT02308787|Other Pre-specified|Waste Bag Volume||Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||mL|Participants|Standard Deviation|Mean
3679|NCT02308787|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||cells x 10^3/L|Participants|Standard Deviation|Mean
3680|NCT02308787|Primary|Adverse Events||during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.||Number of subjects with at least 1 AE|||Number
3681|NCT02308787|Primary|Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.|(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)|on average this will be within 15 minutes after the end of the procedure|At Site 2, percent processed platelets could only be calculated for 1 procedure in Subject 214; no waste bag (depletion product) platelet counts were available for the other 9 procedures performed at Site 2.||% of processed platelets|Participants|Standard Deviation|Mean
3682|NCT02308787|Primary|Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure|(PLTpre - PLTpost) / PLTpre x 100%|on average this will be within 15 minutes after the end of the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.||% change in PLT count in subject blood|Participants|Standard Deviation|Mean
3683|NCT02308748|Secondary|Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day.|Evening dose (moxifloxacin+diltiazem) versus afternoon dose (diltiazem alone).|5 weeks|All study participants that completed placebo, moxifloxacin and moxifloxacin + diltiazem||ms||95% Confidence Interval|Mean
3684|NCT02308748|Primary|Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day|After 3rd dose of mexiletine or lidocaine (evening dose) on treatment day when combined with dofetilide to evening dose on dofetilide alone day.|5 weeks|All study participants that completed placebo and dofetilide alone as well as dofetilide + mexiletine and/or dofetilide + lidocaine||ms||95% Confidence Interval|Mean
3685|NCT02308371|Secondary|Number of Days in the PICU|Number of days for admission pediatric critical care unit (admission during which subject was enrolled into the study)|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)|||days||Standard Deviation|Mean
3686|NCT02308371|Secondary|Number of Days on Ventilatory Support|Number of days subject was on ventilatory support (during time of subject enrollment) to the pediatric critical care unit. This included subjects that were intubated or was on a ventilator with a tracheotomy|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)|||days||Standard Deviation|Mean
3687|NCT02308371|Secondary|Number of Hours on Vasopressors|Hours that a subject remained intubated during pediatric intensive care admission during subject recruitment|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)|||hours||Standard Deviation|Mean
3688|NCT02308371|Primary|Total Fluid Bolused|Total fluid bolused within 48 hours after enrollment.|48 hours after enrollment|||ml/kg||Standard Deviation|Mean
3689|NCT02308371|Primary|Total Fluid (ml/kg/Day) Given|Total fluid (ml/kg/day) given during the first 48 hours of enrollment|First 48 hours after enrollment|||ml/kg/day||Standard Deviation|Mean
3690|NCT02307318|Secondary|Incidence of Hematoma and/or Ecchymosis|Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.|Day1|||Participants|||Count of Participants
3691|NCT02307318|Secondary|Changes in Circulation, Movement and Sensation|Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.|Day1|||Participants|||Count of Participants
3692|NCT02307318|Primary|Incidence of Thrombosis|Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.|4 hours post-surgery|||Participants|||Count of Participants
3693|NCT02307318|Primary|Incidence of Arterial Bleeding|Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.|Day1|||Participants|||Count of Participants
3694|NCT02307266|Primary|Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)|"To prevent bias, treatment adherence was assessed without subject’s knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100.~Analysis was performed on the worst-case population: Missing data were considered as non-adherence."|week 12|Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population.||percentage of adherence||Standard Deviation|Mean
3695|NCT02307188|Primary|Atrial Fibrillation Dominant Frequency|Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.|1 year|Because the quality of intracardiac electrogram data for the one patient to complete the study was not sufficient for analysis, this outcome measure was not analyzed.|||||
3696|NCT02307123|Secondary|Glasgow Outcome Score (GOS)|GOS 1 = Death GOS 2 = Poor neurological outcome GOS 3 = Good neurological outcome Modified from the original 5 - step classification.|1 year|||percentage of good neurological outcome|||Number
3697|NCT02307123|Primary|Mortality||1 year|||percentage of one year mortality|||Number
3719|NCT02305017|Primary|Cmax - Maximum Plasma Concentration|Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||ng/mL||Standard Deviation|Mean
41439|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 12M|||mmHg||Standard Deviation|Mean
3698|NCT02306928|Primary|50% fT>4xMIC: Free Piperacillin Concentration Maintained at a Level Fourfold the MIC for at Least 50% of the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||participants|||Number
3699|NCT02306928|Secondary|Trough Piperacillin Plasma Concentration (Cmin)|Trough plasma concentration (Cmin) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||mg/L||Inter-Quartile Range|Median
3700|NCT02306928|Secondary|The Area Under the Plasma-concentration Time Curve Concentration-time Curve From 0-8 Hours After the Studied Dose (AUC 0-8)|Area under the free plasma concentration-time curve (fAUC0-8) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||mg.hr/L||Inter-Quartile Range|Median
3701|NCT02306928|Secondary|The Maximum Concentration of Piperacillin (Cmax)|Maximum plasma concentration was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||mg/L||Inter-Quartile Range|Median
3702|NCT02306928|Primary|100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.|||participants|||Number
3703|NCT02305446|Other Pre-specified|Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.|The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.|Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.|The analysis was performed on the all enrolled dataset.||Participants|||Number
3704|NCT02305446|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.|From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)|Analysis were evaluated on the Unsolicited Safety Set||Subjects|||Number
3705|NCT02305329|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||h.ng/mL||Standard Deviation|Mean
3706|NCT02305329|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t||before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||h.ng/mL||Standard Deviation|Mean
3707|NCT02305329|Secondary|Tmax - Time of Occurrence of Cmax of 9-1067|tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||hours||Full Range|Median
3708|NCT02305329|Primary|Cmax - Maximum Observed Plasma Concentration of 9-1067|Cmax - maximum observed plasma concentration of 9-1067.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose|||ng/mL||Standard Deviation|Mean
3709|NCT02305316|Secondary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity|AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||ng.h/mL||Standard Deviation|Mean
3710|NCT02305316|Secondary|Tmax - Time of Occurrence of Cmax of BIA 9-1067|tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||hours||Full Range|Mean
3711|NCT02305316|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration|AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||ng.h/mL||Standard Deviation|Mean
3712|NCT02305316|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.|||ng/mL||Standard Deviation|Mean
3713|NCT02305277|Secondary|Tmax - Time of Occurrence of Cmax||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose|||hours||Full Range|Median
3714|NCT02305277|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067|Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration|before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose|||ng.h/mL||Standard Deviation|Mean
3715|NCT02305277|Primary|Cmax - Maximum Observed Plasma Concentration||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose|||ng/mL||Standard Deviation|Mean
3716|NCT02305017|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.|AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||ng.h/mL||Standard Deviation|Mean
3717|NCT02305017|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification|AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||ng.h/mL||Standard Deviation|Mean
3718|NCT02305017|Secondary|Tmax - Time of Occurrence of Cmax|Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose|||hours||Full Range|Mean
3721|NCT02304926|Secondary|Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration|The intercellular adhesion molecule 1 (ICAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||ng/ml||Standard Deviation|Mean
3722|NCT02304926|Secondary|Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration|The vascular cell adhesion molecule 1 (VCAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||ng/ml||Standard Deviation|Mean
3723|NCT02304926|Primary|Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration|Levels of apolipoprotein B were determined by inmunonephelometry|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
3724|NCT02304926|Secondary|Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy.The rolling velocity in the field of focus was determined by measuring the time required by 20 consecutive leukocytes to cover a distance of 100 μm.|Baseline, 4 weeks and 8 weeks|||micrometer/second||Standard Deviation|Mean
3725|NCT02304926|Secondary|Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Adhesion was evaluated by counting the number of polymorphonuclear cells that maintained stable contact with human umbilical vein endothelial cells (HUVEC) for 30 seconds.|Baseline, 4 weeks and 8 weeks|||polymorphonuclear cells/mm2||Standard Deviation|Mean
3726|NCT02304926|Primary|Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration|LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.|Baseline, 4 weeks and 8 weeks|||Angström||Standard Deviation|Mean
3727|NCT02304926|Primary|Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration|Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
3728|NCT02304926|Secondary|Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Leukocyte rolling was estimated as the number of leukocytes rolling over 100 μm2 of the endothelial monolayer during a 1-min period.|Baseline, 4 weeks and 8 weeks|||polymorphonuclear cells/min||Standard Deviation|Mean
3729|NCT02304926|Secondary|Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (levels of glutathione (GSH)) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks|||Fluorescence Units||Standard Deviation|Mean
3730|NCT02304926|Secondary|Membrane Potential Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (membrane potential) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks|||Fluorescence Units||Standard Deviation|Mean
3731|NCT02304926|Secondary|Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (Reactive oxygen species (ROS) production) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks|||Fluorescence Units||Standard Deviation|Mean
3732|NCT02304926|Secondary|Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (mitochondrial oxygen (O2) consumption) was measured at baseline and after treatment by Clark electrode|Baseline, 4 weeks and 8 weeks|||Nmol O2/min/million cells||Standard Deviation|Mean
3733|NCT02304926|Primary|Triglycerides Before and After Simvastatin/Ezetimibe Administration|Triglyceride concentration were measured by enzymatic assay|Baseline, 4 weeks and 8 weeks|||mg/dl||Inter-Quartile Range|Median
3734|NCT02304926|Primary|High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration|High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
3735|NCT02304926|Secondary|Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (tumor necrosis factor α (TNF-α)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||pg/ml||Standard Deviation|Mean
3736|NCT02304926|Secondary|Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (interleukin-6 (IL-6)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks|||pg/ml||Standard Deviation|Mean
3737|NCT02304926|Secondary|Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration|Levels of high-sensitive C-reactive protein (hsCRP) were analysed by a latex-enhanced inmunonephelometric assay|Baseline, 4 weeks and 8 weeks|||mg/l||Standard Deviation|Mean
3738|NCT02304926|Primary|Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration|Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald.|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
3739|NCT02304926|Primary|Total Cholesterol Before and After Simvastatin/Ezetimibe Administration|Total cholesterol concentration was measured by enzymatic assay|Baseline, 4 weeks and 8 weeks|||mg/dl||Standard Deviation|Mean
3740|NCT02303743|Secondary|Patient Satisfaction Were Assessed With a Specific Questionnaire|Patient satisfaction were assessed with a specific questionnaire before colonoscopy. Patients were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers. The items read as follows: (1) “Do you have experience with a previous colonoscopy?”; (2) “Have you used the phone application?”; (3) “How easy was the preparation for colonoscopy?”; (4) “Which is your level of satisfaction with the bowel preparation?”; (5) “Would you like to repeat the same preparation in the future?”; (6) “Did you have any difficulty with the preparation?”. Patient responses to the questionnaire were categorical (yes or no; questions 1, 2, 5, and 6) or numerical scale answers (0 to 10), from very difficult or very bad (0 or close to 0) to very easy or very good (10 or close to 10) (items 3 and 4).|Day 1|||units on a scale||Standard Deviation|Mean
3917|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting|Data not collected at this time point.|||||
3741|NCT02303743|Primary|Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure|The quality of bowel cleansing is evaluated after colonoscopy (Day 1). Baseline the patients initiated low fiber diet in the 24 hours prior to colonoscopy. The HCS uses a 5-point qualitative scale in 5 separate colon segments. HCS is the sum of 5 segments, ranging from 0 (worst possible outcome) to 20 (best possible outcome). Global score assesses the quality of bowel cleansing: Successful (A or B) / unsuccessful (C or D). A: All segments scored 3 or 4; B: One or more segments scored 2; C: One or more segments scored 1; and D: One or more segments scored 0.|Day 1|||units on a scale||Standard Deviation|Mean
3742|NCT02303704|Secondary|Operative Mortality|Deaths due to surgical complication during or after surgery.|Within 30 days after surgical Procedure|all patients who underwent surgery and monitored for death due to surgical complication.||participants|||Number
3743|NCT02303704|Secondary|Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support|The need of IABPC (mechanical support) before surgery or during weaning from Cardiopulmonary bypass and in ICU to assist in maintaining hemodynamics of the patient.|24 hours before surgery and upto 1 week of surgical procedure.|All patients who underwent surgery and for whom IABP support was required.||participants|||Number
3744|NCT02303704|Secondary|Pharamacological Inotropic Support (Dobutamine)|The Need, Dose and duration of Dobutamine to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Dobutamine was used to wean off the patients from Cardiopulmonary Bypass.||ug/kg/min||Standard Deviation|Mean
3745|NCT02303704|Secondary|Pharmacological Inotropic Support (Nor-adrenaline)|The need, dose and duration of Nor-adrenaline infusion to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Nor-adrenaline was used to wean off the patients from Cardiopulmonary Bypass.||ug/kg/min||Standard Deviation|Mean
3746|NCT02303704|Secondary|Pharmacologic Inotropic Support (Adrenaline)|The need, dose and duration of adrenaline infusion to maintain hemodynamic stability after surgery were noted.|Upto 1 week after sugery|All patients in whom Adrenaline was used to wean off the patients from Cardiopulmonary Bypass.||ug/kg/min||Standard Deviation|Mean
3747|NCT02303704|Primary|Post-op CK-MB Levels|CK-MB is a marker of Myocardial Damage.|36 hours after surgery.|All patients in whom Peak CKMB levels were noted within 24 hours after surgery||IU/L||Standard Deviation|Mean
3748|NCT02302365|Other Pre-specified|Waste Bag Volume|Volume of the depletion product|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets||mL|Participants|Standard Deviation|Mean
3749|NCT02302365|Other Pre-specified|Platelet Change (% Change)|% change in patient's pre and post-depletion procedure platelet counts|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.||percent change|Participants|Standard Deviation|Mean
3750|NCT02302365|Other Pre-specified|Procedure Duration||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets||minutes|Participants|Standard Deviation|Mean
3751|NCT02302365|Other Pre-specified|Average Inlet Flow Rate||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Set||mL/min|Participants|Standard Deviation|Mean
3752|NCT02302365|Post-Hoc|Total Blood Volumes (TBV) Processed|Number of times the patient's TBV was processed during the apheresis procedure based on the patient's estimated TBV (Estimated by Nadler's formula for total blood volume of a human being based on gender, height, and weight).|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets||TBV|Participants|Standard Deviation|Mean
3753|NCT02302365|Other Pre-specified|Whole Blood Processed (mL)|volume of patient's blood processed during the apheresis procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets||mL|Participants|Standard Deviation|Mean
3754|NCT02302365|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.||cells x 10^3/L|Participants|Standard Deviation|Mean
3755|NCT02302365|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure||Prior to Each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets.||cells x 10^3/L|Participants|Standard Deviation|Mean
3756|NCT02302365|Other Pre-specified|Patient's WBC Count Post-depletion Procedure||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.||cells x 10^9/L|Participants|Standard Deviation|Mean
3757|NCT02302365|Other Pre-specified|Patient's WBC Count Pre-depletion Procedure||Prior to Each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets.||cells x 10^9/L|Participants|Standard Deviation|Mean
3758|NCT02302365|Primary|Adverse Events||Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, < 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%).||Number of subjects with at least 1 AE|||Number
3759|NCT02302365|Primary|Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.|(WBC/µL product x product volume) / ((WBCpre + WBCpost) / 2) x total processed blood volume)|immediately: on average this will be within 15minutes after the end of the procedure|The CE of the WBCD procedures as measured from the waste bag (depletion product) contents was 58.7% (SD: 16.1%) across Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1.||percent of processed WBCs|Participants|Standard Deviation|Mean
3918|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to injection of “deep” anesthesia in the breast parenchyma, within approximately 4 minutes of starting|Data not collected at this time point.|||||
3760|NCT02302365|Primary|Percent Change in White Blood Cell Count in Patient Following Apheresis Procedure|(WBCpre - WBCpost) / WBCpre x 100%|immediately after procedure: on average this will be within 15minutes after the end of the procedure|Full and Safety Analysis Sets. Data were collected for 43 subjects who underwent a total of 58 WBCD procedures. One subject terminated her first procedure prematurely and therefore did not have post-procedure data. Percent decrease in white blood cell count in patient following apheresis procedure measured for 57 procedures in 43 subjects.||% change in subject's WBC count|Participants|Standard Deviation|Mean
3761|NCT02301429|Primary|All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.|All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.|1 month|all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis||Adverse Events|||Number
3762|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)|Response of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months|3 months|||units on a scale||Standard Deviation|Mean
3763|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)|Response of the participants to the treatment burden domain of the CFQ-R at the end of 3 months|3 months|||units on a scale||Standard Deviation|Mean
3764|NCT02301377|Primary|Medication Adherence|Overall adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins based on prescription refill data. The actual number of prescriptions of each of the three medications filled in the 3-month period was divided by the number that should have been filled based on the prescribed amount of each medication and that value was multiplied by a 100 to generate a percentage.|3 months|||Percent Adherence||Standard Deviation|Mean
3765|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).|"Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.~Lower values represent a better outcome"|Time zero equals baseline (Day 1) up to Day 28|||units on a scale||Standard Deviation|Mean
3766|NCT02301169|Secondary|Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period|11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.|Time zero equals baseline (Day 1) up to Day 28|||units on a scale||Standard Deviation|Mean
3767|NCT02301169|Secondary|Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)|IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.|Time zero equals baseline (Day 1) up to Day 28|||units on a scale||Standard Deviation|Mean
3768|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)|11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42|||units on a scale||Standard Deviation|Mean
3769|NCT02301169|Primary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment|11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42|||units on a scale||Standard Deviation|Mean
3770|NCT02300311|Secondary|Patient's Assessment of the Efficacy on the Last Individual Treatment Day|Patients were asked to rate the effect of the study medication for relieving their low back pain using a 4-point verbal rating scale (1=Poor, 2= Fair, 3=Good, 4=Very Good).|1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||percentage of participants|||Number
3771|NCT02300311|Secondary|Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day|"Difference of average pain intensity from pre-dose baseline on the last individual treatment day (The last individual treatment day was the last day on which the patient had recorded the study drug applications within the patient diary). Pain intensity was assessed by the patient using 0-10 numerical rating scale (NRS).~Patients were given two 0-10 numerical rating scales (NRS) - to self-report of pain intensity at given time points for the period 0-8 hours post first dose and to self-report of average pain intensity they had at each treatment day. The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’. APIDtime point = APItime point - PI baseline (time point is the last individual treatment day (either Day 1, 2, 3 or 4 after drug administration)).~Means reported are the adjusted means."|Baseline and 1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||points on a scale||Standard Error|Mean
3772|NCT02300311|Secondary|Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after trial medication application. The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’. PID4h= PI(4h) - PI(baseline). Means reported are the adjusted means.|Baseline and 4 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||points on a scale||Standard Error|Mean
3773|NCT02300311|Primary|Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)|"Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after trial medication application.~The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’.~PID8h= Pain intensity (PI)8h - PI(baseline).~Means reported are the adjusted means."|Baseline and 8 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.||points on a scale||Standard Error|Mean
3775|NCT02300025|Primary|Apparent Volume of Distribution (Vz/F)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F after the oral dose is influenced by the fraction absorbed.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||Liter||Standard Deviation|Mean
3776|NCT02300025|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||Liter per hr (L/hr)||Standard Deviation|Mean
3777|NCT02300025|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration of cobimetinib to decrease by one half.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||hr||Standard Deviation|Mean
3778|NCT02300025|Primary|Apparent Terminal Elimination Rate Constant (λZ)|λZ was defined as the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||1 per hr (1/hr)||Standard Deviation|Mean
3779|NCT02300025|Primary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC% extrapolated was defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as [AUC (0-∞) minus AUC(0-t]*100/ AUC (0-∞), where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-t) is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||% extrapolated||Standard Deviation|Mean
3780|NCT02300025|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) was defined as AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t- ∞).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.||ng*hr/mL||Standard Deviation|Mean
3781|NCT02300025|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t) was defined as area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK Population.||ng*hr/mL||Standard Deviation|Mean
3782|NCT02300025|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population.||hrs||Full Range|Median
3783|NCT02300025|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|Pharmacokinetic (PK) population included all participants who received at least one dose of cobimetinib and had evaluable PK data.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
3784|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|20 minutes|||participants|||Number
3785|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|Baseline|||participants|||Number
3786|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|20 minutes|||units on a scale||Standard Deviation|Mean
3787|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|Baseline|||units on a scale||Standard Deviation|Mean
3788|NCT02299869|Primary|Cosmetic Appearance Preference|Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference|20 minutes|||participants|||Number
3789|NCT02299635|Secondary|Number of Notch Genomic Alterations in Participants With NA+ mTNBC|Number of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
3790|NCT02299635|Secondary|Number of Participants With Laboratory Test (Urinalysis) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 urinalysis test abnormalities for urine protein.|Day 1 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
3791|NCT02299635|Secondary|Number of Participants With Laboratory Test (Chemistry) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 chemistry test abnormalities|Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
3792|NCT02299635|Secondary|Number of Participants With Laboratory Test (Hematology) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 hematological test abnormalities.|Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles.|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
3793|NCT02299635|Secondary|Number of Participants With Treatment-Emergent AEs by CTCAE Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AEs were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
3794|NCT02299635|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as all deaths, regardless of cause, from treatment start until 28 days after the last dose and non-fatal events occurring after treatment start regardless of cause, up until 28 days after the last dose or until start of new anti-cancer treatment, whichever was first.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.||participants|||Number
3795|NCT02299635|Secondary|Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood.|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.|||||
3796|NCT02299635|Secondary|Pharmacodynamic (PD) Effects of PF‑03084014 in Tumor Specimens and Peripheral Blood|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.|||||
3797|NCT02299635|Secondary|Pre-dose Serum Concentration (Ctrough) for PF-03084014||Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PK analyses were performed for this study.|||||
3798|NCT02299635|Secondary|Type of Notch Genomic Alterations in Participants With NA+ mTNBC|Type of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
3799|NCT02299635|Secondary|Overall Survival (OS) in Participants With NA+ or NA mTNBC|OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
3800|NCT02299635|Secondary|One-Year Survival Probability in Participants With NA+ or NA mTNBC|Overall survival (OS) status (alive or not) at 1 year after study entry. The the survival probability at 1 year was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events.|1 year|Data for this outcome measure was not collected due to early termination of this study.|||||
3801|NCT02299635|Secondary|Duration of Response (DR) in Participants With NA+ or NA mTNBC|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
3802|NCT02299635|Secondary|Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC|The period from study entry until disease progression, death, whichever occurred first as per RECIST version 1.1.|2 years|Data for this outcome measure was not collected due to early termination of this study.|||||
3803|NCT02299635|Secondary|OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)|OR status based on assessment of confirmed CR or confirmed PR according to RECIST 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis <10 mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.|||||
3804|NCT02299635|Primary|Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+)|OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than [<]10 millimeter [mm]). PR: Greater than or equal to (>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.|||||
3805|NCT02299427|Primary|Simulated Behavior With Dogs on Standardized Objective Scale|Coded behavior in dollhouse simulation. Specifically, in 7 simulated scenarios using a dollhouse that included child and dog characters, furniture, yard, etc., children heard a scene and explained/used the dolls to act what would happen next. For example, the experimenter acted a child doll playing in the kitchen near dog food and the doll dog entered, saw the child, and approached the food bowl. The experimenter said, “[Child’s Name] is playing around in the kitchen near [Dog name’s] food. [Dog’s name] comes into the kitchen and sees [Child’s Name] near his/her food bowl making him/her upset and start to growl. What will happen next?” The task was coded using objective coding criteria to score the child’s response as safe (1 point), safe but not optimal (0.5 points), or unsafe (0 points). Scores across the 7 scenarios were summed to yield a single score; possible range = 0=7. Higher scores indicate better safety. Inter-rater reliability on 30% of the sample was good; kappa = .90.|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure||units on a scale||Standard Deviation|Mean
5384|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
3806|NCT02299427|Primary|Children's Behavior With Dogs on Standardized Objective Scale|Coded behavior using objective criteria during a semi-structured interaction with a live therapy dog. Specifically, we examined behavioral patterns for 15 tasks/activities/decisions the child made with the live dog. Sample tasks were when and how the child touched the dog, the extent to which the child was close or intimate to the dog, whether the child handled the dog’s toys, and whether the child interrupted the dog during its “rest time”. 7 of those hung together in factor analysis. Those 7 were standardized and then averaged to create the scale. It was transformed with linear transformation so all values are positive. Higher numbers indicate higher risk-taking. Theoretically the scale is 0-infinity; in practice most children scored between 0-4. The individual items had an average intercorrelation of .50 and Cronbach's alpha of .65.|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure||units on a scale||Standard Deviation|Mean
3807|NCT02299349|Secondary|MS04 Equivalent Consumption|in hospital total MS04 equivalent consumption|1 day following surgery|||mg||Inter-Quartile Range|Median
3808|NCT02299349|Primary|Pain Scores (Visual Analog Pain Scores)|visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)|1 day following surgery|||units on a scale||Standard Deviation|Mean
3809|NCT02299258|Secondary|Adverse Events|bleeding, abdominal pain|up to 5 years|||participants|||Number
3810|NCT02299258|Primary|Efficiency of Stents|number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study|up to 5 years|||participants|||Number
3811|NCT02298868|Secondary|Change in Severity of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured severity on a 0-10 analog scale (0 is no pain, 10 is most severe pain) and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess severity of muscle cramps. This was then compared to the end of therapy severity to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)|||units on a scale||Standard Deviation|Mean
3812|NCT02298868|Secondary|Change in Frequency of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess frequency of muscle cramps. This was then compared to the end of therapy frequency to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)|||days/week||Standard Deviation|Mean
3813|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)|Proportion of patients with somnolence at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
3814|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)|Proportion of patients with endephalopathy at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
3815|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)|Proportion of patients with dizziness at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
3816|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)|Proportion of patients with nausea at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
3817|NCT02298868|Secondary|Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured severity in a 0-10 analog scale (0 is no pain and 10 is most severe pain). These measures were repeated after 4 weeks of therapy and the difference was assessed (4 weeks of therapy-Baseline).|Baseline to end of 4 weeks of therapy|||units on a scale||Standard Deviation|Mean
3818|NCT02298868|Secondary|Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps. This measures was repeated after 4 weeks of therapy and reported as the mean decrease in frequency of muscle cramps (4 weeks of therapy-Baseline).|Baseline to 4 weeks of therapy|||days/week||Standard Deviation|Mean
3819|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)|Proportion of patients with headache at any time during the 4 weeks of therapy|4 weeks of active therapy|||participants|||Number
3820|NCT02298361|Primary|Proportion of Patients Who Lost Medicaid Coverage|Proportion of participants who lost Medicaid coverage after a period of insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to lose coverage).|6 months pre- through 16 months post-tool implementation|||participants|||Number
3821|NCT02298361|Primary|Proportion of Patients Who Gained Medicaid Coverage|Proportion of participants who gained Medicaid coverage after a period of uninsurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to gain coverage).|6 months pre- through 16 months post-tool implementation|||participants|||Number
3822|NCT02298361|Primary|Percent of Study Period Covered by Medicaid|Percent of total days in 22-month assessment period that each child was covered by Medicaid insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources).|6 months pre- through 16 months post-tool implementation|||participants|||Number
3823|NCT02297841|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24, 48, and 72 hours after patch application|||participants|||Number
3826|NCT02296931|Primary|Error in the Total Volume Dispensed and Flow Rate|This is the error value for the volume dispensed by the AutoSyp device relative to the volume intended to be dispensed. Preeclamptic subjects received an initial loading dose followed by a maintenance dose. The loading dose had a flow rate of 60 mL/hr and delivered 20 mL in a single 20 mL syringe. The maintenance dose was 5 mL/hr and dispensed 120 mL total through two 60 mL syringes. The healthy subjects experienced variable flow rates and dispensed volumes, so they do not have the same variables as the pre-eclamptic pregnant women in the outcome data tables below. Because of these differences in dosing the two arms of the study, healthy women and preeclamptic women have different outcome measure data.|1 day visit|||percentage of error||Full Range|Mean
3827|NCT02295774|Primary|Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy|Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.|2 weeks|FAS = 10||number of positive biopsies|||Number
3828|NCT02295644|Primary|Intraoral Muscle Temperature|Using digital thermometer on buccal mucosa, degrees celsius.|Immediately before and after the intervention, difference used.|||degrees Celsius, post minus pre||Standard Deviation|Mean
3829|NCT02295644|Primary|Pressure Pain Threshold of the Masseter Muscle|Measuring pressure pain threshold using digital algometer|Immediately before and after the intervention, difference used.|||Kpa/Cm^2||Standard Deviation|Mean
3830|NCT02295644|Primary|Self Report of Pain|Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever|Immediately before and after the intervention, difference used.|||Scores on pain intensity scale||Standard Deviation|Mean
3831|NCT02295020|Primary|Visual Analog Scale|identifies pain level|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.|||||
3832|NCT02295020|Primary|WOMAC|assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.|||||
3833|NCT02295020|Primary|Oxford Knee Score||Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.|||||
3834|NCT02295020|Primary|Synovial Fluid Analysis (MCP - 1)|Monocyte chemotactic protein-1 - 1|Week 8 -day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
3835|NCT02295020|Primary|Synovial Fluid Analysis (MIP - 1alpha)|Macrophage Inflammatory Proteins - 1alpha|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
3836|NCT02295020|Primary|Synovial Fluid Analysis (TNF-alpha)|Tumor necrosis factor - alpha in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
3837|NCT02295020|Primary|Synovial Fluid Analysis (IL-8)|Interleukine 8 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
3838|NCT02295020|Primary|Synovial Fluid Analysis (IL-6)|Interleukine 6 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.||pg/mL||Full Range|Median
3839|NCT02295020|Primary|KOOS - QOL|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||pg/mL||95% Confidence Interval|Least Squares Mean
3840|NCT02295020|Primary|KOOS - Sport/Rec|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
3841|NCT02295020|Primary|KOOS - ADL|Value at 8 weeks - value at day 0|week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
3842|NCT02295020|Primary|KOOS - Symptoms|Value at 8 weeks - value at day 0|Week 8 - Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
3843|NCT02295020|Primary|KOOS - Pain|Value at 8 weeks - value at day 0|Week 8- Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.||units on a scale||95% Confidence Interval|Least Squares Mean
3844|NCT02294773|Other Pre-specified|Pregnancy Rate Per Body Mass Index Category||Up to cycle day 35|||pregnancies per cycle|||Number
3845|NCT02294773|Other Pre-specified|Pregnancy Rate Per Semen Morphology Score|Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores.|Up to cycle day 35|||pregnancies per cycle|||Number
3846|NCT02294773|Other Pre-specified|Pregnancy Rate Per Female Partner Age|Pregnancy rate will be compared between patients <35 and >35 at time of study entry.|Up to cycle day 35|||pregnancies per cycle|||Number
3847|NCT02294773|Other Pre-specified|Per Cycle Pregnancy Rate Based on Infertility Diagnosis||Up to cycle day 35|||pregnancies per cycle|||Number
3848|NCT02294773|Primary|Number of Pregnancies Achieved Per Menstrual Cycle.||Up to 3 months|||pregnancies per cycle|||Number
3849|NCT02294604|Secondary|Duration of Hand Washing|The secondary outcome is the duration of hand washing|Immediately|||Minute||Standard Error|Mean
3850|NCT02294604|Secondary|Microorganisms on Hands After Surgery|The secondary outcomes is the colonies grown on bacterial culture plate|2 days after sampling|||colony forming unit||Standard Error|Mean
3851|NCT02294604|Secondary|Microorganisms on Hands After Scrubbing|The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling|||colony forming unit||Standard Error|Mean
3852|NCT02294604|Primary|Microorganisms on Hands Before Scrubbing|The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling|||colony forming unit||Standard Error|Mean
3853|NCT02294019|Secondary|Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview.|Day1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.||percentage of participants||95% Confidence Interval|Number
3854|NCT02294019|Primary|Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.|Day 1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.||percentage of participants||95% Confidence Interval|Number
3855|NCT02293538|Secondary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 14, after 2 hours of lens wear|Intention to treat participants with non-missing observations||ICU||Standard Deviation|Mean
3856|NCT02293538|Secondary|Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations||hours||Standard Deviation|Mean
3857|NCT02293538|Secondary|Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses|Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations||percentage of participants|||Number
3858|NCT02293538|Secondary|Mean Comfortable Lens Wear Time (Time Uncomfortable – Time Insertion) at Baseline and Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations||hours||Standard Deviation|Mean
3859|NCT02293538|Primary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 1, after 2 hours of lens wear|Intention to treat participants with non-missing observations||ICU||Standard Deviation|Mean
3860|NCT02292433|Secondary|Change From Baseline in Pre-Meal C-Peptide at Day 7|Time-matched change from baseline in pre-meal serum C-peptide on Day 7 of each period was analyzed. Pre-meal C-peptide levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||ng/mL||Standard Deviation|Mean
3861|NCT02292433|Secondary|Change From Baseline in Pre-Meal Insulin at Day 7|Time-matched change from baseline in pre-meal serum insulin on Day 7 of each period was analyzed. Pre-meal insulin levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||micro international unit per milliliter||Standard Deviation|Mean
3919|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting|Data not collected at this time point.|||||
3862|NCT02292433|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment|FPG was defined as plasma glucose measurements taken pre-breakfast, in the fasted state, and prior to dosing with study drug. Baseline was defined as the average of Hour 0 measurements taken on Day 0 and Day 1 in each intervention period. The measurement on the last day of treatment was defined as the average of Hour 0 measurements taken on Day 7 and Day 8 in each period.|Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||mg/dL||Standard Deviation|Mean
3863|NCT02292433|Secondary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7|WMDG was defined as time-weighted mean daily glucose. WMDG was calculated by as the time-weighted mean of glucose levels at actual time points for glucose sampling, for Day 0 (Baseline) and Day 7.|Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7|The pharmacodynamic (PD) analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.||mg/dL||Standard Deviation|Mean
3864|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
3865|NCT02292433|Secondary|Accumulation Ratio (Rac) on Day 7 for PF-06455349|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
3866|NCT02292433|Secondary|Terminal Half-Life (t1/2) on Day 7 for PF-06455349|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) * 2/k el, where ‘k el’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.||hour||Standard Deviation|Mean
3867|NCT02292433|Secondary|Average Plasma Concentration (Cav) on Day 7 for PF­-06455349|Cav is the average plasma concentration during the 0 to 24 hour time period. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3868|NCT02292433|Secondary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF­-06455349|Ctrough is the concentration prior to study drug administration. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3869|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-­06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
3870|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
3871|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF­-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3872|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
4988|NCT02229864|Secondary|Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 37 days|||percentage of participants|||Number
3873|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF­-06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
3874|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
3875|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3876|NCT02292433|Primary|Accumulation Ratio (Rac) on Day 7 for PF-04937319|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
3877|NCT02292433|Primary|Apparent Volume of Distribution on Day 7 for PF-04937319|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||liter||Geometric Coefficient of Variation|Geometric Mean
3878|NCT02292433|Primary|Terminal Half-Life (t1/2) on Day 7 for PF-04937319|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where ‘k el’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Standard Deviation|Mean
3879|NCT02292433|Primary|Apparent Oral Clearance on Day 7 for PF-04937319|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
3880|NCT02292433|Primary|Average Plasma Concentration (Cav) on Day 7 for PF-04937319|Cav is the average plasma concentration during the 0 to 24 hour time period.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3881|NCT02292433|Primary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319|Ctrough is the concentration prior to study drug administration.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
3882|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
3883|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
3884|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5385|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
3885|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
3886|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||hour||Full Range|Median
3887|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|Pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
3888|NCT02292433|Primary|Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.||participants|||Number
3889|NCT02292433|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.||participants|||Number
3890|NCT02291510|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the first dose of study medication administration (0 h) to the time of the last quantifiable concentration following dose administration. Doses were administered 1 min prior to 0 h (standardized dinner) for qPM and BID dosing and 1 min prior to 12 h (standardized breakfast) for qAM and BID dosing.|Time points to create Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng/mL||Standard Error|Mean
3891|NCT02291510|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration after the standardized dinner. Doses were administered 1 min prior to 0 h (standardized dinner) for once daily in the evening (qPM) and twice daily (BID) dosing and 1 min prior to 12 h (standardized breakfast) for once daily in the morning (qAM) and BID dosing.|Time points to create AUC (0-t) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng*h/mL||Standard Error|Mean
3892|NCT02291419|Other Pre-specified|The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions||up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
3893|NCT02291419|Secondary|Non-fatal Stroke|Time to first occurence of Non-fatal stroke. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
3894|NCT02291419|Secondary|All-cause Death|Time to first occurence of All-cause death. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
3895|NCT02291419|Secondary|Non-fatal Myocardial Infarction or Coronary Revascularization|Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
3896|NCT02291419|Secondary|Cardiovascular Death|Time to first occurence of Cardiovascular death. The number of patients with events was reported.|Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
3897|NCT02291419|Primary|Major Adverse Cardiovascular Events|Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.|||Participants|||Count of Participants
3920|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the biopsy, within approximately 20 minutes of starting|||units on a scale||Standard Deviation|Mean
3921|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting|||units on a scale||Standard Deviation|Mean
3898|NCT02290509|Primary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.|Day 0 and Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.||titer||95% Confidence Interval|Geometric Mean
3899|NCT02290509|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)||Six months post-vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.||participants|||Number
3900|NCT02290509|Secondary|Number of Participants With Systemic and Injection Site Reactogenicity||Days 0-7|The Reactogenicity Population includes subjects who recorded any systemic reaction data and injection site reaction data following administration of study vaccine. This was two subjects less than the Safety Population.||participants|||Number
3901|NCT02290509|Primary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.||percentage of participants||95% Confidence Interval|Number
3902|NCT02289755|Secondary|Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion|Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%|7 days|All Participants (N=16) were included in the analysis.||percentage change||Standard Deviation|Mean
3903|NCT02289755|Primary|Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion|Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).|7 days|All Participants (N=16) completed treatment and were included in the analysis population.||mg/day||Standard Deviation|Mean
3904|NCT02289742|Secondary|Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 8, each product|This analysis population includes all randomized and exposed subjects with data at visit.||percentage of subjects|||Number
3905|NCT02289742|Primary|Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 12, each product|This analysis population includes all randomized and exposed subjects with data at visit.||percentage of subjects|||Number
3906|NCT02289105|Other Pre-specified|Participant Selections on ADs and Declination Forms||Baseline - up to 1 year||||||
3907|NCT02289105|Secondary|Proportion of Participants Who Return a Signed AD|This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.|Baseline - up to 1 year|||proportion of participants||95% Confidence Interval|Number
3908|NCT02289105|Secondary|Proportion of Participants Who Already Have ADs||Baseline - up to 1 year|||proportion of participants|||Number
3909|NCT02289105|Primary|Proportion of Participants That Select to Complete an Advance Directive|We will analyze the effects of the active choice intervention on rates of completion.|Baseline - up to 1 year|||proportion of participants||95% Confidence Interval|Number
3910|NCT02289079|Secondary|Patient Satisfaction as Assessed Via Patient Survey|To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.|assessed at 72 hours after injection|||participants satisfied with pain control|||Number
3911|NCT02289079|Secondary|Post Operative Length of Stay|To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block|up to 30 days after surgery|||Hours||Standard Deviation|Mean
3912|NCT02289079|Secondary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours|||scores on a scale||Full Range|Median
3913|NCT02289079|Primary|Post Operative Opioid Use|To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block|0-72 hours after injection|||micrograms of fentanyl equivalents||Full Range|Median
3914|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting|Data not collected at this time point.|||||
3915|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.|||||
3916|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.|||||
3922|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the skin, within approximately 1 minute of starting|||units on a scale||Standard Deviation|Mean
3923|NCT02288364|Primary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to anesthetizing, within approximately 1 minute of starting|||units on a scale||Standard Deviation|Mean
3924|NCT02288312|Secondary|AUC0-∞ (BIA 2-005)|AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||ng.h/mL||Standard Deviation|Mean
3925|NCT02288312|Secondary|Tmax (BIA 2-005)|tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||hours||Standard Deviation|Mean
3926|NCT02288312|Secondary|AUC0-t (BIA 2-005)|AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||ng.h/mL||Standard Deviation|Mean
3927|NCT02288312|Primary|Cmax (BIA 2-005)|Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.|||ng/mL||Standard Deviation|Mean
3928|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10|||% times patients had specific CGM/24-hr||Standard Error|Least Squares Mean
3929|NCT02288273|Secondary|Change in HbA1c From Baseline to Day 22 and Baseline to Day 70||Day 22 and Day 70|||% Alc||Standard Error|Least Squares Mean
3930|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10|||mg/dL||Standard Error|Least Squares Mean
3931|NCT02288273|Secondary|Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)||Day 22 and Day 64|||mg/dL||Standard Error|Least Squares Mean
3932|NCT02288273|Secondary|Change From Baseline (Day1) to Day 70 and Day 22 in FPG||Day 22/Day70|||mg/dL||Standard Error|Least Squares Mean
3933|NCT02288273|Secondary|Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient||Day 64/65|||mg/dL||Standard Error|Least Squares Mean
3934|NCT02288273|Primary|Change in 24-hour Mean Weighted Glucose|Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).|Day 27/28|||(mg/dL)|(mg/dL)|Standard Deviation|Mean
3935|NCT02287779|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626)||Day 1 to Day 14|Pharmacokinetic set. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.|||||
3936|NCT02287779|Secondary|Maximum Observed Plasma Concentration (Cmax) of Volixibat||Day 1 to Day 14|Pharmacokinetic set consisted of all participants in the safety analysis set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.|||||
3937|NCT02287779|Secondary|Number of Participants With Stool Hardness Using Bristol Stool Chart|Stool hardness was assessed after each evacuation using the bristol stool chart, a medical aid designed to classify the form of human feces into 7 categories where type 1 is the hardest and type 7 is the softest.|Day -2 to Day 14|Pharmacodynamic set.||participants|||Number
3938|NCT02287779|Secondary|Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration|Serum 7- alpha-hydroxy-4-cholesten-3-one (C4) concentrations were reported.|Day -1 to Day 15|Pharmacodynamic set.||nanogram per milliliter||Standard Deviation|Mean
3939|NCT02287779|Secondary|Average Total Fecal Bile Acid (FBA) Concentration|Stool samples for the determination of total FBA were collected in 48-hour windows from 48 hours before dosing on Day 1 through Day 14. The average of daily total FBA excretion is calculated before (Day -1 and Day -2) as the first pre dose of IMP and after (Day 1-12) as the first post-dose of IMP. The FBA is calculated as Total FBA (micromoles) = FBA (micromol per liter) * weight (grams) divided by 10^3. Participants with fecal bile acid concentration and their average pre-first dose and average post-first dose were reported.|Day -2 up to Day 14|Pharmacodynamic set consisted of all participant in the safety analysis set for whom the primary pharmacodynamic data were considered sufficient and interpretable.||nanomoles*gram per liter||Standard Deviation|Mean
3940|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3941|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3951|NCT02287623|Secondary|Post Operative Opioid Use|Post operative opioid use from 0-24 hours after surgery.|0-24 hours|||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
3952|NCT02287623|Secondary|Postoperative Opioid Use|Use of opioids during 24-48 hours after surgery|24-48 hours|||Micrograms of fentanyl equivalents||Inter-Quartile Range|Median
3953|NCT02287623|Secondary|Post Operative Length of Stay||up to 30 days after surgery|||HOURS||Inter-Quartile Range|Median
3954|NCT02287623|Secondary|Number of Patients With Post Operative Nausea/Vomiting||0-72 hours|||participants|||Number
3942|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Twelve lead electrocardiogram parameters [(heart rate (HR), PR, RR, QRS and QT intervals and information on T-wave morphology (normal/abnormal) and U-wave morphology (absent/normal or abnormal)] were assessed.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3943|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Vital signs parameter included evaluation of orthostatic blood pressure, respiratory rate and body temperature.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3944|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Urinalysis parameters included evaluation of pH, glucose, protein, nitrites, leukocyte esterase, occult blood, ketones, bilirubin and specific gravity levels.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3945|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Standard chemistry parameters included evaluation of sodium, potassium, glucose, blood urea nitrogen, creatinine, calcium, chloride, thyrotropin, thyroxine, tri-iodothyronine, phosphorus, protein, bicarbonate or carbon dioxide, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, total bilirubin, urate, beta-human chorionic gonadotropin and follicle-stimulating hormone levels. Participant with TEAE related to standard chemistry were reported with hepatic enzyme increase.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set||participants|||Number
3946|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Coagulation included international normalized ratio, activated partial thromboplastin time and prothrombin time.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3947|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Thyroid hormone panel parameters included evaluation of thyroid hormones (TSH [thyroid stimulating hormone]; T3 [triiodothyronine] and T4 [thyroxine]).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3948|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Lipid panel parameters included evaluation of total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and low-density lipoprotein (LDL) cholesterol.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3949|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Fat soluble vitamin included vitamin A (serum retinol), vitamin D (serum 25-hydroxycholecalciferol) and vitamin E (serum alfa-tocopherol).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.||participants|||Number
3950|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology|TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white blood cell count; total and differential, neutrophils (absolute), eosinophils (absolute), monocytes (absolute), basophils (absolute) and lymphocytes (absolute).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set included all participants for whom a randomization number was assigned and who had taken >= 1 dose of IMP.||participants|||Number
3955|NCT02287623|Secondary|Post Operative Opioid Use||48-72 hours|||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
3956|NCT02287623|Primary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours after injection|||scores on a scale||Inter-Quartile Range|Median
3957|NCT02287610|Other Pre-specified|Correlation Between Vectra DA and DAS28 at Each Assessed Time Point|Vectra DA and DAS28 data were collected, however not analyzed or correlated.|Baseline to Last Follow up visit (up to 18.7 weeks)|Analysis and correlations were not completed for this outcome measure.|||||
3958|NCT02287610|Secondary|Assessment of Unsolicited Serious Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)|||Participants|||Count of Participants
3959|NCT02287610|Secondary|Assessment of Unsolicited Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)|||Participants|||Count of Participants
3960|NCT02287610|Secondary|Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)|The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants.|Baseline to Last Follow up visit (up to 18.7 weeks)|||milligrams||Standard Deviation|Mean
3961|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked “Yes” (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – recent medical history was calculated for participants who had both baseline and follow-up recent medical history data. For this measure, the mean change from baseline is based on 33 participants.||number of items checked||Standard Deviation|Mean
3962|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to “Fatigue is no problem” and 10 to “Fatigue is a major problem” over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – fatigue (FAT) was calculated for participants who had both baseline and follow-up FAT data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3963|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)|The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: “3 or more times a week” (3), “1-2 times per week” (2), “1-2 times per month” (1), “Do not exercise regularly” (0), “Cannot exercise due to disability/handicap” (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – exercise (EX) was calculated for participants who had both baseline and follow-up EX data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3964|NCT02287610|Secondary|"Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)"|The Multidimensional Health Assessment Questionnaire (MDHAQ) – how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in “How do you feel” measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire - How do you feel today (compared to 1wk ago) from Baseline to Final Visit was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Error|Mean
3965|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – morning stiffness, minutes (past week) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 30 participants.||minutes||Standard Deviation|Mean
3996|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
3966|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – review of symptoms (ROS) was calculated for participants who had both baseline and follow-up ROS data. For this measure, the mean change from baseline is based on 33 participants.||number of symptoms||Standard Deviation|Mean
3967|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – patient global assessment (PTGL) was calculated for participants who had both baseline and follow-up PTGL data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3968|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)|For the Multidimensional Health Assessment Questionnaire (MDHAQ) – neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as “None” (score of 0), “Mild” (score of 1), “Moderate” (score of 2) or “Severe” (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – neck and back (NB) was calculated for participants who had both baseline and follow-up NB data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3969|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)|For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as “None” (score of 0), “Mild” (score of 1), “Moderate” (score of 2) or “Severe” (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – RADAI patient self-report joint count (PTJT) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3970|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to “No Pain” and 10 to “Pain as bad as it could be” because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Pain (PN) was calculated for participants who had both baseline and follow-up PN data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3971|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)|The change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as “without any difficulty” (score of 0), “with some difficulty” (score of 1.1), “with much difficulty” (score of 2.2) or “unable to do” (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Psychological status (PS) was calculated for participants who had both baseline and follow-up PS data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3997|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
3972|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)|The change in Multidimensional Health Assessment Questionnaire (MDHAQ) – function (FN) was assessed by asking participants to score the performance of multiple activities as “without any difficulty” (score of 0), “with some difficulty” (score of 1), “with much difficulty” (score of 2) or “unable to do” (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Function (FN) was calculated for participants who had both baseline and follow-up FN data. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3973|NCT02287610|Secondary|Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)|"Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up.~RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Routine Assessment of Patient Index Data (RAPID3) was calculated for participants who had both baseline and follow-up data required to calculate RAPID3. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3974|NCT02287610|Secondary|ACR-N From Baseline to Final Visit (Final Follow-up Visit)|ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set–Patient’s global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician’s global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR-N scores and 5 participants have only baseline data. ACR-N calculations were performed on data from 24 participants.||percent change||Standard Deviation|Mean
3975|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 70 a patient must demonstrate a >= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR70 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.||percentage of particpants|||Number
3976|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 50, a patient must demonstrate a >= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only Baseline data. The percentages were calculated based on 56 participants.||percentage of participants|||Number
3977|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 20, a patient must demonstrate a >= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.||percentage of participants|||Number
3978|NCT02287610|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)|"European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), >3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 >5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined.~DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity)."|Baseline to Last Follow up visit (up to 18.7 weeks)|||percentage of participants|||Number
3979|NCT02287610|Secondary|Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)|Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Simple Disease Activity Index (SDAI) was calculated for participants who had both baseline and follow-up data required to calculate SDAI. For this measure, the mean change from baseline is based on 25 participants.||units on a scale||Standard Deviation|Mean
3980|NCT02287610|Secondary|Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)|"Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition.~As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Clinical Disease Activity Index (CDAI) was calculated for participants who had both baseline and follow-up data required to calculate CDAI. For this measure, the mean change from baseline is based on 33 participants.||units on a scale||Standard Deviation|Mean
3981|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.36 * the natural logarithm (ln) of (CRP + 1)] + [0.014 * PGA in mm] + 0.96. A negative change from baseline indicated improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Disease Activity Score in 28 Joints calculated with C-reactive protein (DAS28-CRP) was calculated for participants who had both baseline and follow-up data required to calculate DAS28-CRP. For this measure, the mean change from baseline is based on 25 participants.||units on a scale||Standard Deviation|Mean
3982|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * PGA in mm]. A negative change from baseline indicates improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in DAS28-ESR was calculated for participants who had both baseline and follow-up data required to calculate DAS28-ESR. For this measure, the mean change from baseline is based on 15 participants.||units on a scale||Standard Deviation|Mean
3998|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to progression to type 2 diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
8496|NCT02092649|Secondary|Change in Maximum Oxygen Consumption From Baseline||Baseline, 12 weeks|||percent change||Standard Deviation|Mean
3983|NCT02287610|Secondary|Change in Physician’s Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|Physician’s Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to “Very Well’ and 10 to “Very Poor”. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician’s Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow-up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Physician’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Physician’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 37 participants.||units on a scale||Standard Deviation|Mean
3984|NCT02287610|Secondary|Change in Patient’s Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|Patient’s Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient’s Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Patient’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Patient’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 36 participants.||units on a scale||Standard Deviation|Mean
3985|NCT02287610|Secondary|Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. The change in duration of morning stiffness (minutes) was calculated for participants who had both baseline and follow-up morning stiffness data. For duration of morning stiffness, the mean change from baseline is based on 41 participants.||minutes||Standard Deviation|Mean
3986|NCT02287610|Primary|Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit|Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to “Not Severe at All” and 100 to “Extremely Severe”. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Mean change in severity of morning stiffness was calculated for participants who had both baseline and follow-up severity of morning stiffness data. For severity of morning stiffness, the mean change from baseline is based on 38 participants.||units on a scale||Standard Deviation|Mean
3987|NCT02287415|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.|||ng.h/mL||Standard Deviation|Mean
3988|NCT02287415|Secondary|Tmax - Time of Occurrence of Cmax||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.|||hours||Full Range|Median
3989|NCT02287415|Primary|Cmax - Maximum Steady-state Plasma Concentration||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.|||ng/mL||Standard Deviation|Mean
3990|NCT02287402|Secondary|Body Weight at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||kg||Standard Deviation|Mean
3991|NCT02287402|Secondary|Body Weight|"Summary statistics were calculated at each assessment time point for the body weight in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||kg||Standard Deviation|Mean
3992|NCT02287402|Secondary|HbA1c at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||percent||Standard Deviation|Mean
3993|NCT02287402|Secondary|Hemoglobin A1c (HbA1c)|"Summary statistics were calculated at each assessment time point for the HbA1c in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percent||Standard Deviation|Mean
3994|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g OGTT at Follow-up|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the Full Analysis Set."|Follow-up at week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||mg/dL||Standard Deviation|Mean
3995|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the Full Analysis Set."|Week 0, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||mg/dL||Standard Deviation|Mean
4013|NCT02286518|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
3999|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to progression to Type 2 Diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||percentage of participants|||Number
4000|NCT02287402|Primary|Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)|"Frequency tabulations of the assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.||participants|||Number
4001|NCT02287402|Primary|Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)|"Frequency tabulations of the assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in the Full Analysis Set."|Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.||participants|||Number
4002|NCT02286518|Secondary|Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1|Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected.|Day 1: 0 to 48 hours postdose|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||percentage of dose||Standard Deviation|Mean
4003|NCT02286518|Secondary|Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3|Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||ratio||Standard Deviation|Mean
4004|NCT02286518|Secondary|Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3|Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||ratio||Standard Deviation|Mean
4005|NCT02286518|Secondary|Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114||Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||hour||Standard Deviation|Mean
4006|NCT02286518|Secondary|AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3||Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||pg*hr/mL||Standard Deviation|Mean
4007|NCT02286518|Secondary|AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2||Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||picogram*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
4008|NCT02286518|Secondary|Cmax - Maximum Observed Plasma Concentration for TAK-114||Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
4009|NCT02286518|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
4010|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1|The safety analysis set includes all participants who received the study drug.||participants|||Number
4011|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)|Number of participants who had ECG shifts from “within normal limit” at baseline to “abnormal, clinically significant” after study drug administration were reported.|Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
4012|NCT02286518|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.||participants|||Number
5386|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
4014|NCT02286518|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)|The safety analysis set includes all participants who received the study drug.||participants|||Number
4015|NCT02286193|Secondary|Number of Participants Setting a Goal With Their CRS|Number of patients who completed at least one visit with the CRS and set a specific action-based goal with their CRS. Patients could meet with the CRS and receive referrals to resources without setting specific action-based goals. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months|||participants|||Number
4016|NCT02286193|Primary|Number of Participants Receiving a Resource for Community Services|Number of patients who completed at least one visit with the CRS and were given a referral for at least one resource, service, or organization. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months|||participants|||Number
4017|NCT02285998|Secondary|Number of Participants With Systemic Reactogenicity|Solicited events of systemic reactogenicity reported during Day 0-7.|Days 0 through 7|Solicited systemic reactogenicity events include subjects who recorded any systemic reaction data.||participants|||Number
4018|NCT02285998|Secondary|Measure of Post-vaccination HAI GMTs|GMT titers for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.||titer||95% Confidence Interval|Geometric Mean
4019|NCT02285998|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)|"Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination).~A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment."|Day 0 through and up to 32 weeks post vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.||participants|||Number
4020|NCT02285998|Secondary|Number of Participants With Unsolicited Adverse Events|Unsolicited adverse events reported in the 28 days following vaccine administration.|Days 0 through 28|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.||participants|||Number
4021|NCT02285998|Secondary|Number of Participants With Local Injection Site Reactogenicity|"Solicited events of injection site reactogenicity reported during Day 0-7.~Participants reported the following solicited events:~Local Pain Local Tenderness Local Redness (measurement in mm) Local Firmness/Swelling (measurement in mm)"|Days 0 through 7|Solicited local reactogenicity events include subjects who recorded any injection site reaction data.||participants|||Number
4022|NCT02285998|Secondary|Percentage of Participants With Seroconversion|Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.||percentage of participants||95% Confidence Interval|Number
4023|NCT02285998|Secondary|Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness|rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
4024|NCT02285998|Secondary|Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness|"Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines.~CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat."|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
4025|NCT02285998|Secondary|Number of Participants With Culture-confirmed Influenza-Like Illness|"Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines.~Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms:~Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)"|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
4026|NCT02285998|Primary|Number of Participants With rtPCR-confirmed Influenza-Like Illness|rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.||participants|||Number
4027|NCT02285270|Secondary|Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.|||||
4028|NCT02285270|Secondary|Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.|||||
4029|NCT02285270|Primary|Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.|||||
4093|NCT02282605|Secondary|The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests.||Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.|||participants|||Number
4030|NCT02284880|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|"Reference - MF - marketed formulation Test - TBM - to-be-marketed~BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period|||ng.hr/ml||Standard Deviation|Mean
4031|NCT02284880|Primary|Tmax - Time of Occurrence of Cmax|"Reference - MF - marketed formulation Test - TBM - to-be-marketed~BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period|||hours||Full Range|Median
4032|NCT02284880|Primary|Cmax - Maximum Plasma Concentration|Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period|||ng/ml||Standard Deviation|Mean
4033|NCT02284867|Secondary|Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups|CD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.|2 years|||participants|||Number
4034|NCT02284867|Primary|Uterine Natural Killer Cells In Preterm Labor|Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample|2 years|||participants|||Number
4035|NCT02284854|Primary|AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg~CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35|||ng*h/mL||Standard Deviation|Mean
4036|NCT02284854|Primary|AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35|||ng*h/mL||Standard Deviation|Mean
4037|NCT02284854|Primary|AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35|||ng*h/mL||Standard Deviation|Mean
4038|NCT02284854|Primary|Cmax (CBZE) - the Maximum Plasma Concentration|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily~CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35|||ng/mL||Standard Deviation|Mean
4039|NCT02284854|Primary|Cmax (CBZ) - the Maximum Plasma Concentration|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35|||ng/mL||Standard Deviation|Mean
4040|NCT02284854|Primary|Cmax (BIA 2-093) - the Maximum Plasma Concentration|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35|||ng/mL||Standard Deviation|Mean
4041|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
4042|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
4043|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
4044|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
4045|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
4046|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose|||miliseconds||Standard Deviation|Mean
4047|NCT02284555|Secondary|The Number of Subjects With Adverse Events and Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up at 7 and 14 Days Relative to the First Dose.||5 day treatment period and follow-up at 7 and 14 days|||participants|||Number
4048|NCT02284555|Primary|Apparent Eradication of Nasal Carriage of SA|Apparent eradication demonstrated by a semi-quantitative score of negative or zero using a broth enriched culture microbial assay.|48 hours after the last dose of mupirocin 2%|||participants|||Number
4049|NCT02284386|Primary|The Apparent Terminal Elimination Half-life (t1/2el)||Baseline through Day 14|||hours||Standard Deviation|Mean
4050|NCT02284386|Primary|The Apparent Terminal Elimination Rate Constant (λz)||Baseline through Day 14|||1/hours||Standard Deviation|Mean
4051|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)||Baseline through Day 14|||hours x ng/mL||Standard Deviation|Mean
4052|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)||Baseline through Day 14|||hours x ng/mL||Standard Deviation|Mean
4053|NCT02284386|Primary|Time to Peak Plasma Concentration (Tmax)||Baseline through Day 14|||hours||Full Range|Median
4054|NCT02284386|Primary|Maximum Plasma Concentration (Cmax)||Baseline through Day 14|Of 15 subjects, one subject was removed as an outlier||ng/mL||Standard Deviation|Mean
4055|NCT02284347|Secondary|Device Safety Profile as Measured by the Overall Adverse Event Rate|Overall adverse event rate|2 weeks|||Percentage of participants with an AE|||Number
4056|NCT02284347|Primary|Device-related Adverse Event Point Estimate|The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.|2 weeks|Participants||Adverse Events||95% Confidence Interval|Number
4057|NCT02284347|Primary|Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium|Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium|At time of surgery|All patients that completed the study||Number of sinuses|||Number
4058|NCT02284165|Secondary|Number of Participants Who Died Within 12 Months of Stroke Hospitalization|Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.||participants|||Number
4059|NCT02284165|Secondary|Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.|All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.||participants|||Number
4060|NCT02284165|Secondary|Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.|Institutionalization (primary living location in a nursing home for long-term care and not for rehabilitation or short-term skilled stay) as measured by patient or proxy family member report on 12-month follow-up phone call.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 patients met these criteria.||participants|||Number
4061|NCT02284165|Secondary|Quality of Life (QOL)|EuroQOL-5 Dimensions (EQ-5D) to assess health-related quality of life by asking and scoring the level of severity (1 = no problems, 2 = some problems, 3 = extreme problems) in 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score for each question is added together to provide total score, which is converted to provide a range from 1 (maximum and highest health state for quality of life) down to 0 (lowest health state and quality of life).|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 323 patients met these criteria.||units on a scale||Inter-Quartile Range|Median
4062|NCT02284165|Secondary|Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge|12-month functional status as measured by modified Rankin scale scores ranging between 0 (no symptoms) and 6 (death), among patients discharged to inpatient rehabilitation or skilled nursing facility. Outcome measure reports number of participants with Rankin score of 3-6. The outcome was not assessed among patients discharged home.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 participants met these criteria.||participants|||Number
4063|NCT02284165|Primary|Home-time|Number of days alive and living outside of inpatient care|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehab or skilled nursing care and without survival limitations identified in-hospital. 69,212 patients met these criteria.||days||Standard Deviation|Mean
4064|NCT02284165|Primary|Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services|Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.|discharge through 90 days|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, analyzed as one cohort rather than by arm to differentiate the different types of rehabilitation services within the full patient population.||participants|||Number
4065|NCT02283840|Primary|Tmax BIA 2-005 - Time of Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration|||hours||Standard Deviation|Median
4066|NCT02283840|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration|||ng.h/mL||Standard Deviation|Mean
4067|NCT02283840|Primary|Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration|||ng/mL||Standard Deviation|Mean
4068|NCT02283827|Secondary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration|||hours||Standard Deviation|Median
4069|NCT02283827|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|"AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time~BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate"|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration|||ng*h/mL||Standard Deviation|Mean
4070|NCT02283827|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration|||ng/mL||Standard Deviation|Mean
4071|NCT02283814|Secondary|AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.||Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h|||ng.h/mL||Standard Deviation|Mean
4072|NCT02283814|Primary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h|||hours||Standard Deviation|Mean
41440|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 6M|||mmHg||Standard Deviation|Mean
4073|NCT02283814|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h|||ng/mL||Standard Deviation|Mean
4074|NCT02283788|Secondary|QTcF - QT Interval Corrected Using Fridericia’s Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose||||||
4075|NCT02283788|Secondary|QTcB - QT Interval Corrected for Heart Rate Using Bazett’s Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose||||||
4076|NCT02283788|Primary|QTcI - QT Interval Individually Corrected for Heart Rate - Day 5||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose|||msec||Standard Deviation|Mean
4077|NCT02282982|Secondary|Proportion of Participants With a Particular Co-morbidity|The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
4078|NCT02282982|Secondary|Median Duration of Oxygen Administration During Hospitalizations|The median duration of mechanical oxygen administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
4079|NCT02282982|Secondary|Median Duration of Mechanical Ventilation Administration During Hospitalizations|The median duration of mechanical ventilation administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
4080|NCT02282982|Secondary|Proportion of Participants With Co-morbidities During Hospitalizations|The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
4081|NCT02282982|Secondary|Proportion of Participants With Missed Doses of Palivizumab|The proportion of participants with missed or delayed doses of palivizumab was documented.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
4082|NCT02282982|Secondary|Proportion of Participants Who Received Mechanical Ventilation While Hospitalized|The proportion of participants who received mechanical ventilation while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
4083|NCT02282982|Secondary|Proportion of Participants Who Received Supplemental Oxygen While Hospitalized|The proportion of participants who received supplemental oxygen while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
4084|NCT02282982|Secondary|Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)|The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
4085|NCT02282982|Secondary|Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants|The number of hospitalized participants admitted to the Intensive Care Unit was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||participants|||Number
4086|NCT02282982|Secondary|Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test|The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test||days||Full Range|Median
4087|NCT02282982|Primary|Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection|Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
4088|NCT02282982|Primary|Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test|Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season||participants|||Number
4089|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Per protocol||participants|||Number
4090|NCT02282813|Secondary|Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Intent to treat||participants|||Number
4091|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Per protocol||participants|||Number
4092|NCT02282813|Primary|Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Intent to treat||participants|||Number
4094|NCT02282605|Secondary|AUC of the Semi-quantitative SA Scores From Nasal Swabs|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Mean changes from baseline (0h) to each timepoint (Day 1,12 h; Day 2, 24 h: Day 3, 48h; Day 4, 84h; Day 7, 144h; Day 14, 312h) were calculated by treatment for the semi-quantitative SA scores. The AUC of the semi-quantitative SA scores were calculated for the two-day treatment period (AUC Day1- Day2); through the two day treatment period and up to discharge (AUC Day 1- Day4); and over the two-day treatment period, discharge and follow-up (AUC Day1- Day14). AUC was calculated by means of a trapezoidal rule using a standard algorithm. A higher AUC is indicative of a higher bacterial growth.|2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up|A comparison between treatment groups was performed separately for each AUC with an ANCOVA model with AUC as dependent variable, treatment as fixed effect and baseline SA (0 hours) as covariate. The AUC is a cumulative measure, comparison could be performed only within the same time period therefore data was normalised over time.||units on a scale||Standard Deviation|Mean
4095|NCT02282605|Secondary|Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score|The number of subjects with absence of SA from nasal swabs at the specified time-points..|Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose)|||participants|||Number
4096|NCT02282605|Secondary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14.|Exploratory comparisons between active groups versus placebo of the percentage of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.||participants|||Number
4097|NCT02282605|Primary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).|Exploratory comparisons between active groups versus placebo of the number of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.||participants|||Number
4098|NCT02281591|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
4099|NCT02281591|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
4100|NCT02281591|Primary|Tmax - the Time of Occurrence of Cmax||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||hours||Standard Deviation|Mean
4101|NCT02281591|Primary|Cmax - the Maximum Plasma Concentration||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|||ng/mL||Standard Deviation|Mean
4102|NCT02281526|Secondary|Cmax - Peak Plasma Concentration|Day 1 - Cmax Peak plasma concentration|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
4103|NCT02281526|Primary|Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).|"Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast).~BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites."|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.|||h·ng/mL||Standard Deviation|Mean
4104|NCT02281448|Secondary|AUC0-t|AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.|||pg.h/mL||Standard Deviation|Mean
4105|NCT02281448|Secondary|Tmax|Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.|||h||Standard Deviation|Mean
4106|NCT02281448|Secondary|Cmax|Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.|||pg/mL||Standard Deviation|Mean
4107|NCT02281448|Primary|Cmax - Maximum Observed Plasma BIA 2-194 Concentration|Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.|Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.|||ng/mL||Standard Deviation|Mean
4108|NCT02281422|Primary|AUC(0-12h) - AUC From Time Zero to 12h|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites~AUC - area under the plasma concentration versus time curve"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.|||ng*h/mL||Standard Deviation|Mean
4109|NCT02281422|Secondary|Tmax (hr) - Time at Which Cmax Occurred|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites~Cmax - maximum observed plasma drug concentration"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.|||hours||Standard Deviation|Mean
4111|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4|||participants|||Number
4112|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
4113|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|||participants|||Number
4114|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4|||participants|||Number
4115|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
4116|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|||participants|||Number
4117|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Week 4|||participants|||Number
4118|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
4119|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 Minutes after PDT|||participants|||Number
4120|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT|||participants|||Number
4121|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|||participants|||Number
4122|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4|||participants|||Number
4123|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
4124|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT|||participants|||Number
4125|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|||participants|||Number
4126|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4|||participants|||Number
4127|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 hours after PDT #1|One subject did not have assessment performed||participants|||Number
4128|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT|||participants|||Number
4129|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|||participants|||Number
4130|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4|||participants|||Number
4131|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24 hours post PDT#1|One subject did not have assessment performed||participants|||Number
4132|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|||participants|||Number
4133|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4|||participants|||Number
4134|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 hours after PDT|One subject did not have assessment performed||participants|||Number
4135|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|||participants|||Number
4136|NCT02281136|Primary|The Terminal Exponential Half-life (T1/2,z)|The terminal slope will be calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.|1 day|T1/2,z could not be determined in 4 subjects||hours||Geometric Coefficient of Variation|Geometric Mean
4137|NCT02281136|Primary|AUCt|AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
4138|NCT02281136|Primary|Time at Which Cmax is Attained (Tmax) for ALA|Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day|||hours||Full Range|Median
4139|NCT02281136|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA|Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples wiere taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.|1 day|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
4140|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at 24 Hours After Transfusion|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter −24 hour diameter)/24 hour diameter × 100.|24 hours after transfusion|||percentage of brachial artery diameter||Standard Deviation|Mean
4192|NCT02276274|Secondary|Number of Participants With Significant Change From Baseline in Electrocardiograms|Clinically significant change in electrocardiograms observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
4141|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at Baseline|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline|||percentage of brachial artery diameter||Standard Deviation|Mean
4142|NCT02280499|Secondary|ASES Shoulder Score Index|The American Shoulder and Elbow Surgeon's (ASES) evaluation is used to document the improvement in pain, function and range of motion after shoulder injury. The ASES Shoulder Score Index is calculated from the ASES patient related questionnaire and ranges from 0-100 with a higher score indicating improvement in pain and function.|10Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The ASES Shoulder Score Index was calculated for 27 participants. As the score is a patient reported outcome the score could be completed at home increasing the number of available scores.||units on a scale||Standard Deviation|Mean
4143|NCT02280499|Secondary|Constant Murley Score|The Constant Murley Score is a shoulder outcome score to determine the functionality of the shoulder after the treatment of a shoulder injury. The score ranges from 0 to 100 with a higher score indicating better shoulder function.|10 Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The Constant Murley Score was incomplete for 3 participants and therefore the number of participants analyzed is 23.||units on a scale||Standard Deviation|Mean
4144|NCT02280499|Primary|Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components|The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.|up to 10 years|||Percentage survivorship||95% Confidence Interval|Number
4145|NCT02280187|Secondary|Fusion Rates in Subgroups|Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.|12 months|||percentage of participants|||Number
4146|NCT02280187|Secondary|Fusion Status at the Last Assessment Performed by 12 Months|According to the study protocol, fusion status was determined to be either success or no success based on the images. If fusion failed at 1 level, the fusion was considered to be failed for the patient. The fusion rate at the last assessment is reported.|12 months|The subjects with the image that unable to determine fusion status and the assessment not done” were not taken into account.||percentage of participants|||Number
4147|NCT02280187|Secondary|The Number of Unplanned Secondary Spine Interventions in Subgroups|The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).|12 months|||participants|||Number
4148|NCT02280187|Secondary|The Number of Subjects Having Secondary Spine Surgical Intervention|The number of subjects who had secondary spine surgical intervention at index level treated with InductOs and other level (either never treated or treated without InductOs) through 12 months is reported.|12 months|||participants|||Number
4149|NCT02280187|Secondary|AEI Categorisation|The number of AEIs is presented by the categories predefined in the study protocol. The AEI MedDRA coded terms are presented in Section of serious adverse event.|12 months|||events|adverse event||Number
4150|NCT02280187|Secondary|The Number of Adverse Events of Interest|An adverse event was considered an event of interest (AEI) if an adverse event was considered important to follow. These included reactions described in the EU product label, events monitored in the EU Risk Management Plan, events that were considered possible related to the treatment by the investigator, and events that had serious health consequences for patients (e.g. hospitalization).|12 months|||events|||Number
4151|NCT02280187|Primary|Instrumentations Used for Stabilization|The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.|during surgery|The total levels in the summary are higher than total amount of levels because multiple answers are possible.||spine level|Spine level||Number
4152|NCT02280187|Primary|Supplemental Fixation|The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).|During surgery|The total levels across all the rows are higher than total number of levels analyzed because some levels may be represented in more than one rows.||spine level|Spine level||Number
4153|NCT02280187|Primary|Placement of the Matrix Wetted With InductOs|The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.|During surgery|The total levels across all the rows are higher than total number of levels analyzed because multiple answers are possible.||spine level|Spine level||Number
4154|NCT02280187|Primary|The Interbody Device Brand/Generic Names Used With InductOs|The number of spine levels with InductOs is presented by interbody brand/generic names.|during surgery|||spine level|Spine level||Number
4155|NCT02280187|Primary|Primary Surgical Approaches Used for Implantation of InductOs|The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.|During surgery|||spine level|Spine level||Number
4156|NCT02280187|Primary|Spine Levels Treated|The number of spine levels from the occiput to S1 is presented.|During surgery|||spine level|Spine level||Number
4157|NCT02280187|Primary|The Primary Diagnostic Indication for InductOs Use|The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.|Baseline|||percentage of participants|||Number
4193|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Body Weight|Clinically significant change participant's body weight observed at any time point are reported.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
4292|NCT02273752|Secondary|Frequency of Treatments for Stomatitis|Frequency of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
4158|NCT02280122|Primary|Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)|First off all patients rinsed with tap water for 30 seconds. Then they spat out the water and waited for 1 min. Now patients rinsed with 5ml of purified water for 30 seconds and spat this sample back into the test cup. Approximately 2 ml of the sampled saliva was now sampled with a syringe. After a filter was put onto the syringe 3 drops of the saliva were pressed through the filter into the ELISA kit. After 5 to 10 min the result was read from the test kit [21]. If both the control and test stripes were visible the respective test was positive (i.e. ≥ 25 ng aMMP 8 per ml). The clinical examiner (SIB) judged the results by simple visual inspection. Already a faint test stripe was judged as positive test. All test results were photographed with 2fold magnification. All images of the test were then evaluated by a second examiner (PE) who was blinded for the clinical diagnoses.|5 minutes|||percentage of true cases (sens./spec.)||95% Confidence Interval|Number
4159|NCT02279667|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||ng*h/mL||Standard Deviation|Mean
4160|NCT02279667|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||ng*h/mL||Standard Deviation|Mean
4161|NCT02279667|Primary|Tmax - the Time of Occurrence of Cmax|Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||hours||Full Range|Median
4162|NCT02279667|Primary|Cmax - the Maximum Plasma Concentration|Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
4163|NCT02279407|Secondary|Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)|To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind treatment.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.||ratio of % liver fat||95% Confidence Interval|Geometric Mean
4164|NCT02279407|Primary|Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)|To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.||ratio of % liver fat||95% Confidence Interval|Geometric Mean
4165|NCT02278783|Secondary|Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response)|To determine the frequency of clinical benefit (stable disease, partial, and complete response) according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria|Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months|Study was terminated early, no analysis performed.|||||
4166|NCT02278783|Secondary|Estimate Progression Free Survival|To estimate progression free survival for patients treated with this regimen|At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months|Study was terminated early, no analysis performed.|||||
4167|NCT02278783|Primary|Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported.|Patients will remain on treatment for approximately 4-6 months on average.|||participants|||Number
4168|NCT02278783|Primary|6 Month Progression Free Survival (PFS)|To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers|Patients will be checked for PFS after 6 months on treatment|||participants|||Number
4169|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.||percentage of participants||95% Confidence Interval|Number
4170|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.||percentage of participants||95% Confidence Interval|Number
4271|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24||Week 24|Participants with available antibody response data at week 24||percentage of participants||95% Confidence Interval|Number
4171|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.||percentage of participants||95% Confidence Interval|Number
4172|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.||percentage of participants||95% Confidence Interval|Number
4173|NCT02278614|Primary|Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye|the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye|Day 84|||mm Hg||Standard Error|Least Squares Mean
4174|NCT02278484|Secondary|Number of Subjects Who Undergo a Revision or Additional Surgery During the Study|Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported|Procedure-6 month follow up|All participants||Participants|||Count of Participants
4175|NCT02278484|Secondary|Change in Quality of Life From Baseline Through Completion|Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers).|Baseline to 6 month follow-up|All participants||Units on a scale: 1 (best) to 7 (worst)||Standard Deviation|Mean
4176|NCT02278484|Primary|Complications|Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.|Index procedure through 3-month follow-up|All participants||participants|||Number
4177|NCT02278484|Primary|Technical Success: Sinuses Successfully Treated With Balloon Dilation|Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.|Index procedure|All sinus dilations attempted in all participants||sinus dilation attempts|Sinuses||Number
4178|NCT02278146|Secondary|Overactive Bladder Arm|Percentage of participants with less daily voids from baseline to 3 weeks.|up to 3 weeks|||percentage of participants|||Number
4179|NCT02278146|Secondary|Stress Incontinence Arm|Percentage of participants with less daily leaks from baseline to 3 weeks.|up to 3 weeks|||percentage of subjects|||Number
4180|NCT02278146|Primary|Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study|Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.|up to 3 weeks|||participants|||Number
4181|NCT02277626|Primary|Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest|Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)|End of study visit per intervention|||units on a scale||Full Range|Mean
4182|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
4183|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention|||percentage of predicted value||Full Range|Mean
4184|NCT02277626|Secondary|Dry Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry|End of study visit per intervention|||gram||Full Range|Mean
4185|NCT02277626|Primary|Wet Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion|End of study visit per intervention|||grams||Full Range|Mean
4186|NCT02277249|Primary|Patient Discomfort With Digoxin Injection (Pain Score)|"Pain score (indicated by patient reporting pain level from 0 (no hurt) to 5 (hurts worst) at time of digoxin injection)"|At time of study (immediate)|||Units on a scale||Standard Deviation|Mean
4187|NCT02277119|Primary|Optic Disc Measurement (Cup Size)|Reporting of the Cup size difference between the Maestro and iVue|1 Hour|||Microns cubed||Standard Deviation|Mean
4188|NCT02277119|Primary|Full Retinal Thickness Measurement|Full Retinal Thicknesses Measurement|1 Hour|Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.||Microns||Standard Deviation|Mean
4189|NCT02277119|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Measurements|RNFL thickness measured|1 Hour|||Microns||Standard Deviation|Mean
4190|NCT02277119|Primary|Optic Disc Measurements (Optic Disc Size)|Reporting of the Optic Disc Size difference between the Maestro and iVue|1 Hour|||Mircrons squared||Standard Deviation|Mean
4191|NCT02276274|Secondary|Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)|Laboratory assessments included hematology, serum chemistry and urinalysis. Any laboratory-related TEAE reported at any time point were reported in this measure.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
4194|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (infra-axillary), supine blood pressure resting more than 5 minutes (systolic and diastolic [Millimeters of mercury]), respiratory rate and pulse (beats per minute). Clinically significant change in vital signs observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
4195|NCT02276274|Secondary|Number of Participants Reporting 1 or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to the day of discharge (Day 4) in the second intervention period|Safety analysis set: All participants who receive at least one dose of study medication.||participants|||Number
4196|NCT02276274|Secondary|Tmax: Time to Reach Emax|Time to reach Emax for the first time was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||hour||Full Range|Median
4197|NCT02276274|Secondary|Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity|Maximum inhibition rate of plasma DPP-4 activity was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||percentage of inhibition||Standard Deviation|Mean
4198|NCT02276274|Secondary|AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours|Area under the inhibition rate of plasma DPP-4 activity-time curve from time 0 to 24 hours was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||percentage of inhibition*hour||Standard Deviation|Mean
4199|NCT02276274|Secondary|DPP-4 Activity|DPP-4 activity was assessed from the plasma samples collected from the participants.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||nanomole/minute/milliliter (nmoL/min/mL)||Standard Deviation|Mean
4200|NCT02276274|Secondary|Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity|DPP-4 activity and inhibition rate of DPP-4 activity was assessed from the plasma samples collected from the participants. Inhibition of DPP-4 enzyme was used to determine the antihyperglycemic activity of the investigational product.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.||percentage of inhibition||Standard Deviation|Mean
4201|NCT02276274|Primary|CLr: Renal Clearance of Metformin|CLr is a measure of apparent clearance of the drug from the urine.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
4202|NCT02276274|Primary|CLr: Renal Clearance of SYR-322Z|CLr is a measure of apparent clearance of the drug from the urine. The clearance is the rate at which waste substances are cleared from the blood.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
4203|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4204|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4205|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4206|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4293|NCT02273752|Secondary|Dose Interruptions and Adjustments|Dose interruptions and adjustments will be made on a per subject basis and total for the population.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
4207|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4208|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 24 hours post dose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4209|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4210|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4211|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4212|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4213|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||percentage of dose||Standard Deviation|Mean
4214|NCT02276274|Primary|Mean Residence Time (MRT) for Metformin|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
4215|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
4216|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for Metformin|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
4217|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for Metformin|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr^-1||Standard Deviation|Mean
4218|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
4219|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Metformin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Full Range|Median
4220|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for Metformin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
4221|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: Subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
4222|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
4223|NCT02276274|Primary|AUC (0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin|AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
4224|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Standard Deviation|Mean
4225|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Standard Deviation|Mean
4226|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr^-1||Standard Deviation|Mean
4227|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng*hr/mL||Standard Deviation|Mean
4228|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Full Range|Median
4229|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng/mL||Standard Deviation|Mean
4230|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||hr||Standard Deviation|Mean
4231|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng*hr/mL||Standard Deviation|Mean
4232|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.||ng*hr/mL||Standard Deviation|Mean
4233|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
4234|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322Z|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). (AUMC [0-inf]) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
4235|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).|3 hours prior to administration, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours after administration|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||L/hr||Standard Deviation|Mean
4236|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322Z|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr||Standard Deviation|Mean
4237|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hr^-1||Standard Deviation|Mean
4238|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
4239|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||hour (hr)||Full Range|Median
4240|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322Z|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng/mL||Standard Deviation|Mean
4241|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||ng*hr/mL||Standard Deviation|Mean
4242|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.||nanogram*milliliter per hour (ng*hr/mL)||Standard Deviation|Mean
4243|NCT02275767|Secondary|% Residual Graft Material (Histological)|histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation|||percentage of total area||Standard Deviation|Mean
4244|NCT02275767|Primary|% Vital Bone Formation (Histological)|histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation|||percentage of total area||Standard Deviation|Mean
4245|NCT02275546|Primary|Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion|Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.|Up to 48 hours after vaginal ring insertion|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
4246|NCT02275546|Primary|Percentage of Participants With Successful Ring Insertion|Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.|Day 1 (immediately after vaginal ring insertion)|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
4247|NCT02275364|Secondary|VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 2 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.||Units on a scale||Standard Deviation|Mean
4248|NCT02275364|Secondary|Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 30 minutes|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.||Units on a scale||Standard Deviation|Mean
4249|NCT02275364|Secondary|Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)|"Regional measures of breathing-related cortical activity were derived by determining Functional Connectivity and Event-related percentage signal change.~Functional connectivity analyzes of fMRI data where spontaneous (i.e. while the participant is at rest) signal changes in one brain region are regressed against other regions, to identify regions sharing similar functional properties.~Event-related functional magnetic resonance imaging (efMRI) detects changes in the BOLD hemodynamic response to neural activity associated with certain event. In this case, the events were pre-defined by collecting additional data during the scan; participant respiration was determined using a simple pressure-sensitive respiration belt. Events time-locked to peak inspiration and expiration were defined separately, and regressed against brain activity, showing brain regions that were more or less active during each event type."|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was prespecified to evaluate the effect on nasal strips on the breathing related brain activity without the use of nasal decongestant||% signal change||Standard Deviation|Mean
4250|NCT02275364|Primary|Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)|Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to evaluate the effect on nasal strips on the measure of brain activity without the use of nasal decongestant.||% signal change||Standard Deviation|Mean
4251|NCT02275364|Primary|Anatomical Measures: Volume (Multiple Volume Reading)|Determination of averaged volume reading during the MRI (Average of 8 sub-regions)|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.||mm^3||Standard Deviation|Mean
4252|NCT02275364|Primary|Cerebral Blood Flow (CBF)|CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject’s whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject’s T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not evaluated in this outcome measure as it was pre-specified to to analyze effect of nasal strips on the cerebral blood without the use of nasal decongestant.||ml/100g/min||Standard Deviation|Mean
4253|NCT02275364|Primary|Anatomical Measure: Volume (Single Volume Reading)|Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.||mm^3||Standard Deviation|Mean
4254|NCT02275364|Primary|Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task|Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to analyze effect on nasal strips on the brain activity without the use of nasal decongestant||% Signal||Standard Deviation|Mean
4294|NCT02273752|Secondary|Percentage of Days on Therapy|Percentage of days on therapy will be calculated using the formula: (expected - actual days)/expected x 100.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
4255|NCT02275364|Primary|Anatomical Measures : Cross Sectional Area|Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.||mm^2||Standard Deviation|Mean
4256|NCT02275156|Secondary|Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)|"Serum PCSK9 concentrations were determined using a qualified ELISA. The LLOQ of the assay was 15 ng/mL.~Log-transformed baseline PCSK9 was included in the model as a covariate and participant as a random effect."|Baseline and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set||percent change||95% Confidence Interval|Geometric Mean
4257|NCT02275156|Secondary|Area Under the Effect Curve From Baseline to Day 57 (AUECday1-57) for Low-density Lipoprotein Cholesterol (LDL-C)|The derived log-transformed AUECday1-57 for direct LDL-C was analyzed using a mixed-effect analysis of variance model. Log-transformed baseline LDL-C was the covariate.|4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set||mg/dL*day||95% Confidence Interval|Geometric Mean
4258|NCT02275156|Secondary|Number of Participants With Anti-evolocumab Antibodies|Blood samples were tested using an electrochemiluminescence-based bridging immunoassay to detect antibodies capable of binding to evolocumab.|57 days|Safety analysis set||participants|||Number
4259|NCT02275156|Secondary|Number of Participants With Clinically Relevant Vital Sign or Clinical Laboratory Changes|The investigator reviewed vital signs and laboratory test results and determined whether an abnormal value in an individual participant represented a clinically significant change from the participant’s baseline values.|57 days|Safety analysis set||participants|||Number
4260|NCT02275156|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal;~life threatening (places the participant at immediate risk of death);~requires in patient hospitalization or prolongation of existing hospitalization;~results in persistent or significant disability/incapacity;~congenital anomaly/birth defect;~other medically important serious event.~The investigator assessed whether each adverse event was possibly related to the study drug."|From the first dose of study drug up until Day 57|Safety analysis set (all participants who received at least 1 dose of study drug)||participants|||Number
4261|NCT02275156|Primary|Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) for Evolocumab||Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|PK analysis set||day*μg/mL||Standard Deviation|Mean
4262|NCT02275156|Primary|Maximum Observed Serum Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.|Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Pharmacokinetic (PK) analysis set (all participants for whom at least 1 PK parameter could be adequately estimated)||μg/mL||Standard Deviation|Mean
4263|NCT02274948|Secondary|Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo|ALT was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||Iu/l||95% Confidence Interval|Mean
4264|NCT02274948|Secondary|Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo|Triglyceride was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||mmol/l||95% Confidence Interval|Mean
4265|NCT02274948|Secondary|Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo|"HOMA IR (Homeostatic model -Insulin Resistance) was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.~Homeostatic model (HOMA-IR = fasting blood sugar(mmol/l) × fasting insulin(mmol/l) ÷ 22.5)"|One year|||units on a scale||95% Confidence Interval|Mean
4266|NCT02274948|Secondary|Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo|Fasting insulin was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||pmol/l||95% Confidence Interval|Mean
4267|NCT02274948|Primary|Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo|BMI and Percentage Fat Mass SDS was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year|||Z score||95% Confidence Interval|Mean
4268|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 12|Participants with a positive anti-etanercept antibody binding response at week 12||percentage of participants||95% Confidence Interval|Number
4269|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 24|Participants with a positive anti-etanercept antibody binding response at week 24||percentage of participants||95% Confidence Interval|Number
4270|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12||Week 12|Participants with available antibody response data at week 12||percentage of participants||95% Confidence Interval|Number
8902|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)||57 days|||µg·h/mL||Standard Deviation|Mean
4272|NCT02274792|Primary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study|Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.|Primary Antibody Analysis Set included all enrolled participants who received ≥ 1 dose of investigational product and had both a baseline and ≥ 1 post-baseline serum obtained for anti-etanercept antibody assessment, excluding participants with a negative antibody response at week 12 and missing antibody assessment at week 24.||percentage of participants||95% Confidence Interval|Number
4273|NCT02274675|Secondary|Wrist's Active Range of Motion|"Introduction: Wrist's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in by moving with their own effort.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized AROM for normal wrist flexion-extension is about 144 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The wrist's AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the subject will move their wrist to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
4274|NCT02274675|Secondary|Wrist's Passive Range of Motion|"Introduction: Wrist's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in flexion-extension directed by a person manually.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized PROM for normal wrist flexion-extension is about 164 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The wrist PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the wrist will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and store as report in its software."|Passive range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
4275|NCT02274675|Secondary|Forearm's Passive Range of Motion|"Introduction: Forearm's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition.The normalized forearm pronation-supination is about 169 angular degree, a person who is able to achieve or over this range is considered normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The forearm PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the forearm will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and stored as report in its software."|Passive range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
4276|NCT02274675|Secondary|Forearm's Active Range of Movement|"Introduction: Forearm's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The normalized AROM for normal forearm pronation-supination is about 157 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree will be 0.~Procedure: The forearm AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the subject will move their forearm to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.||Angular degree||Standard Deviation|Mean
4277|NCT02274675|Secondary|Spasticity Level of Wrist|"Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale.~Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed.~Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch."|Spasticity level of wrist at week 6|Stroke subjects in rehabilitation centre.||Scores||Standard Deviation|Mean
4278|NCT02274675|Secondary|Motor Function Assessment of Hand Movement|"Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement.~Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.~Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor function of hand function at week 6|Stroke subjects in rehabilitation centre.||Scores||Standard Deviation|Mean
4290|NCT02273752|Secondary|Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Response rate will be measured at different time points, e.g. 8, 16, and 24 weeks, and will be summarized as percentage of stable disease, complete remission or partial remission along with 95% confidence interval.|Up to 24 weeks|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
4279|NCT02274675|Primary|Motor Impairment of Wrist and Forearm|"Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.~Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.~Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor impairment of wrist and forearm at week 6|Stroke subjects in rehabilitation centre.||Scores||Standard Deviation|Mean
4280|NCT02273908|Other Pre-specified|Number of Patients With Adverse Events||Visit2(week4),Final Visit(Week8 or discontinuation)|Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.||participants of related AEs|||Number
4281|NCT02273908|Secondary|Work Productivity and Activity Impairment Scale (WPAI:LBP)|"The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline.~In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities."|Final Visit (Week8 or discontinuation)|Full Analysis Set||percentage of time missed||Standard Deviation|Mean
4282|NCT02273908|Secondary|Patient Global Improvement of Change (PGIC)|The PGIC is a subject-rated instrument that measures change in the subject’s overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set||participants|||Number
4283|NCT02273908|Secondary|Clinical Global Impression of Change (CGIC)|The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set||participants|||Number
4284|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -|"The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together.~The Visual Analogue Scale (VAS) is designed to rate the subject’s current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||units on a scale||Standard Error|Least Squares Mean
4285|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-|The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject’s level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, “confined to bed”). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||units on a scale||Standard Error|Least Squares Mean
4286|NCT02273908|Secondary|Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)|The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||scores on a scale||Standard Error|Least Squares Mean
4287|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||scores on a scale||Standard Error|Least Squares Mean
4288|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set||scores on a scale||Standard Error|Least Squares Mean
4289|NCT02273908|Primary|Change From Baseline in Pain Related Sleep Interference Scale (PRSIS – Past Week Recall)|The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.|Baseline, Final Visit (Week 8)|Full Analysis Set; consisted of subjects who had at least one evaluable observation from any of the patient-reported outcomes, and only evaluable subjects who contributed to the particular outcome were evaluated in each analysis. 'n' signifies number of participants who were evaluable for specified categories at different time points||scores on a scale||Standard Error|Least Squares Mean
4291|NCT02273752|Secondary|Type of Treatments for Stomatitis|Type of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
42584|NCT01424813|Other Pre-specified|Percent of Symptom Free Days on the Patient Diary||Treatment days 1 through 85||||||
4295|NCT02273752|Secondary|Downstream Markers of Mammalian Target of Rapamycin (mTOR) Function Measured in Peripheral Blood Mononuclear Cells|Pharmacodynamics will be evaluated for phosphorylated and non-phosphorylated ribosomal protein S6 kinase, protein kinase B, and eukaryotic translation initiation factor 4E-binding protein 1.|Up to day 15 of course 1|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
4296|NCT02273752|Secondary|Progression Free Survival (PFS)|PFS will be evaluated based on rates of cancer progression and time to progression in the population. Progression will be determined using standard RECIST criteria. The median PFS for this study will be estimated by Kaplan-Meier method along with 95% confidence interval.|6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
4297|NCT02273752|Primary|Incidence of Stomatitis|Stomatitis graded rates and severity will be evaluated and recorded per World Health Organization and Common Terminology Criteria for Adverse Events criteria in the study population.|Day 29|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.|||||
4298|NCT02273323|Secondary|Diastolic Blood Pressure Sitting|Diastolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
4299|NCT02273323|Secondary|Systolic Blood Pressure Sitting|Systolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
4300|NCT02273323|Secondary|Diastolic Blood Pressure Supine|Diastolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
4301|NCT02273323|Secondary|Systolic Blood Pressure Supine|Systolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits||mmHg||Standard Deviation|Least Squares Mean
4302|NCT02273323|Secondary|Endothelium-independent Vasodilation|Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter|2.5 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits||percentage of change in diameter||95% Confidence Interval|Least Squares Mean
4303|NCT02273323|Primary|Flow Mediated Dilation|"Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:~1 minute baseline scan to measure the baseline diameter of artery~5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter"|Before and 2 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits||percentage of change in diameter||Standard Deviation|Least Squares Mean
4304|NCT02273310|Secondary|Acceptability of Intervention|Families in the FTC group rated acceptability of participating in the intervention workshop. This measure was completed at the workshop (between baseline and 6 month assessments). This measure utilized a 5-point Likert-type scale (with the possible range of scores as 1-5), with higher scores indicating more positive feedback. Individual item scores are presented here. Participant results indicated a range of scores from from 2-5.|post intervention|||units on a scale||Standard Deviation|Mean
4305|NCT02273310|Secondary|Number of Accommodations Provided to Families by Schools|Number of Accommodations Provided to Families by Schools As reported by caregivers|6 months|||Number of Accommodations||Standard Deviation|Mean
4306|NCT02273310|Secondary|School Functioning-Absences|School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences.|6 months|||Weeks (1 week = 7 days)||Standard Deviation|Mean
4307|NCT02273310|Primary|Child-Reported Health Related Quality of Life-School Functioning Subscale|Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.|6 months|||units on a scale||Standard Deviation|Mean
4308|NCT02271854|Secondary|Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.|"Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome.~Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i."|48 hours|||units on a scale (NRS)||Standard Deviation|Mean
4309|NCT02271854|Primary|Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.|The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.|24 hours|||units on a scale (NRS)||Standard Deviation|Mean
4310|NCT02271529|Primary|Mean Percent Change in Stent Length Upon Deployment||Immediately following completion of the stent placement procedure|There were 63 implanted stents, an assessment of stent length change was not available for 2 stents.||percentage of change in stent length|Participants|Standard Deviation|Mean
4311|NCT02271477|Secondary|Time of Procedures|Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure|From time 0 to 30 minutes after spinal anesthesia|||minutes||Standard Deviation|Mean
4312|NCT02271477|Secondary|Percentage of Participants Administered Vasoactive Drug|"Total amount of vasoactive drug administered for each group; for vasoactive drug we intended the use both of atropine than vascular amine"|30 minutes after spinal anesthesia|||percentage of participants|||Number
4314|NCT02271477|Primary|Rate of Arterial Hypotension|To compare rates of arterial hypotension (previously define by international standard) after spinal anesthesia in patients who have undergone volemic optimization according to Trans-thoracic Echocardiography with patients who have been treated according to the current standard on the intention to treat population.|30 minute after spinal anesthesia|Rate of arterial hypotension after standardized spinal anesthesia||percentage of participants|||Number
4315|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. Images were only recorded during the wall and clavicle position, not during the natural standing position. Pressure mat parameters were recorded for both arm positions and compared to the natural standing position (arms hanging on either side).|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions and pressure mat recording in the two positions and the natural standing position.||percentage of pressure under||Standard Deviation|Mean
4316|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
4317|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
4318|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
4319|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.||degrees||Standard Deviation|Mean
4320|NCT02269488|Primary|Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250|"Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number.~Solicited symptoms are events that are considered likely to occur post dosing. For this study, solicited symptoms include Fever ≥ 100.4°F (38.0°C) by any route, Runny/stuffy nose, Sore throat, Cough, Headache, Generalized muscle aches, Decreased activity level (lethargy) or tiredness/weakness, Decreased appetite and Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) will be omitted when, according to the judgment of the investigator, the subject is too young to reliably report a particular symptom"|14 days post vaccination|||subjects|||Number
4321|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population||Participants|||Number
4322|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|||Participants|||Number
4323|NCT02269475|Primary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population||Participants|||Number
4324|NCT02269098|Other Pre-specified|ED Visits and Hospitalizations|number ED visits and hospitalizations pre and post intervention as self-reported by participants|12 weeks|Self reported Number of ED visits and hospitalizations 3 months prior to and 3 months after the intervention||number of ED visits and hospitlizations|||Number
4325|NCT02269098|Secondary|Hypoglycemia|Hypoglycemia was defined as BG < 70mg/dL. Severe hypoglycemia was defined as BG <40mg/dL and/or requiring assistance to treat. We tracked the total number of hypoglycemia episodes in each group.|4 weeks|we collected data on the total number of hypoglycemia episodes in each group, not the number or participants with hypoglycemia as some participants had more than 1 episode and we wanted to capture those as separate incidents.||total incidents of hypoglycemia|||Number
4326|NCT02269098|Secondary|Blood Glucose < 180mg/dL|Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline|4 weeks|||participants|||Number
4327|NCT02269098|Primary|Medication Adherence|Score on 8 item Modified Morisky Medication Scale used to assess medication adherence. This scale is a structured and widely used self reported questionnaire used to assess medication taking behaviors.The total score ranges from 0 to 8. A score of 0 is considered “high”adherence, 1 to 2 is considered “medium” adherence, and >2 is considered “low” adherence.|4 weeks|33 patients in the intervention group and 30 in the control group completed the scale at baseline and at 4 weeks and their data was analyzed for this outcome measure.||units on a scale||Standard Deviation|Mean
4328|NCT02269098|Primary|Hemoglobin A1C at 4 Weeks|Hemoglobin A1C at index/baseline visit in the ED and at 4 weeks. A1C was measured using the Bayer A1C-Now+ point of care test system device. If the reading was over 13%, the upper limit of the assay, a venous sample A1C was sent to the hospital lab for analysis.|4 weeks|Participants who completed the full 4 week study period were included in the primary outcomes analysis.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
4364|NCT02264249|Secondary|Procedure Complications (Decrease in Oxygen Saturation)|The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.|1 day|||participants|||Number
4329|NCT02268864|Secondary|Number of Participants With Viral Relapse|Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA <LLOQ (undetectable) at EOT and had HCV RNA >=LLOQ during the follow-up period.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||participants|||Number
4330|NCT02268864|Secondary|Number of Participants With Viral Breakthrough|Participants were considered to have had viral breakthrough if they had a confirmed greater than (>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA >100 IU/mL while previously having achieved HCV RNA <LLOQ when on study treatment.|Up to Week 24|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||participants|||Number
4331|NCT02268864|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie, <LLOQ detectable or greater than equal to (>=) LLOQ at EOT.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage of participants|||Number
4332|NCT02268864|Secondary|Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24)|Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 24 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage of participants||95% Confidence Interval|Number
4333|NCT02268864|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4)|Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 4 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage pf participants||95% Confidence Interval|Number
4334|NCT02268864|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (<LLOQ) (detectable or undetectable).|At 12 weeks after end of treatment|The intent-to-treat (ITT) analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.||percentage of participants||95% Confidence Interval|Number
4335|NCT02268396|Secondary|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage of correct advances|||Number
4336|NCT02268396|Secondary|Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)|Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount)|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage|||Number
4337|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage|||Number
4338|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage of devices|||Number
4339|NCT02268396|Secondary|Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage of Devices|||Number
4340|NCT02268396|Primary|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population||Percentage|||Number
4341|NCT02268058|Other Pre-specified|Number of Headaches a Day|the patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period.|one week|||headaches per day||Full Range|Median
4342|NCT02268058|Other Pre-specified|Headache Intensity Per Day for One Week|The Numerical Rating Scale (NRS) will be used to capture the intensity of the headache experience. The NRS was initially developed for acute post procedural pain and is now a common measure for headache and disease related pain with well established reliability and validity as a self report measure in this age group. Children meeting the inclusion criteria also meet the criteria for self report. The numerical rating scale includes indicators from 0 to 10 with 0 being the ‘no pain’ and 10 being ‘the worst pain ever’. The child when diarizing the headaches will report a pain intensity score for each headache type in their one week headache diary. Study participants and their parent will be given instruction regarding reporting the headache instruction. The headache intensity scores were averaged for the day per participant.|one week|||units on a scale||Full Range|Median
4343|NCT02268058|Secondary|Percentage of Study Participants That Returned to School at One Week Post Concussion|patients/family were asked if the child returned to school one week after their injury|one week|||percentage of participants|||Number
4344|NCT02268058|Primary|Number of Headache Days|study participants completed a one week diary at home stating if they had headaches.|one week|||number of headache days||Full Range|Mean
4451|NCT02259400|Secondary|Newborns Who Received Multiple Surfactant Doses||10 days|||participants|||Number
4452|NCT02259400|Secondary|Necrotizing Enterocolitis (NEC)||1 month|||participants|||Number
4345|NCT02267837|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.|||millimeters per week (mm/wk)|Participants|Standard Deviation|Mean
4346|NCT02267824|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.|||millimeters per week (mm/wk)||Standard Deviation|Mean
4347|NCT02266797|Secondary|Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.|The outcomes of surgery will be examined through the 1 year post-operative appointment.|12 months|Data not available due to premature halting of study|||||
4348|NCT02266797|Secondary|Examine the Impact of Dexamethasone on Radicular Pain.|This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.|12 months|Data not available due to premature halting of study|||||
4349|NCT02266797|Secondary|Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.|This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.|Immediate post-operatively|Data not available due to premature halting of study|||||
4350|NCT02266797|Secondary|The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.|Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.|12 months|Data not available due to premature halting of study|||||
4351|NCT02266797|Primary|The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.|Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.|12 months|Data not available due to premature halting of study|||||
4352|NCT02266797|Primary|Intravenous Corticosteroids Effect on Post-operative Dysphagia|The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.|12 months|Data not available due to premature halting of study|||||
4353|NCT02266381|Secondary|Change in Hemoglobin Concentration|Change in hemoglobin concentration is assessed by comparing the preoperative hemoglobin level with 24-hour postoperative hemoglobin level.|within 24 hours after MPCNL|||g/L||Standard Deviation|Mean
4354|NCT02266381|Secondary|Operation Time|Operation time is defined as the time from puncture to the placement of the nephrostomy tube.|intraoperatively|||min||Standard Deviation|Mean
4355|NCT02266381|Secondary|Perioperative Complications|Complication is defined as any adverse event occurred intraoperatively or ≤ 30 days postoperatively. Complications included fever, systemic Inflammatory Response Syndrome, septic shock, extravasations, bleeding necessitating transfusion, and sever bleeding necessitating selective renal artery embolization.|intraoperatively or ≤ 30 days postoperatively|||Participants|||Number
4356|NCT02266381|Primary|Stone Free Rate|Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter >4 mm.|one day after MPCNL|||Participants|||Number
4357|NCT02265848|Other Pre-specified|Preferability|At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one.|End of treatment visit on visit 4|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||participants|||Number
4358|NCT02265848|Secondary|Patient's Global Impression of Change (PGIC)|PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||units on a scale||Full Range|Mean
4359|NCT02265848|Secondary|Oswestry Disability Index Questionnaire (ODI).|ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||units on a scale||Full Range|Mean
4360|NCT02265848|Primary|Numeric Pain Rating Scale (NPRS)|Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.||units on a scale||Full Range|Mean
4361|NCT02264821|Primary|Morphine Consumption|Morphine consumption with PCAIV|30 hours after spinal injection T0|||milligrammes||Inter-Quartile Range|Median
4362|NCT02264821|Secondary|Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.|Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?|30 hours after spinal injection||||||
4365|NCT02264249|Secondary|pH of Gastric Fluid of Different Bowel Preparation Regimens|The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day|||pH||Standard Deviation|Mean
4366|NCT02264249|Primary|Residual Gastric Volumes of Different Bowel Preparation Regimens|The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day|||mL||Standard Deviation|Mean
4367|NCT02263833|Other Pre-specified|Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL||Up to 4 years||||||
4368|NCT02263833|Other Pre-specified|Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion||Up to 4 years||||||
4369|NCT02263833|Primary|Percentage of Participants With an Adverse Drug Reaction (ADR)|ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as “definitely related”,“probably related”, “possibly related”, and “unknown” by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as “Unexpected”. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.||percentage of participants|||Number
4370|NCT02263833|Primary|Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event|An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.||percentage of participants|||Number
4371|NCT02263131|Secondary|Percentage of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, and a Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer||Day28(+7)||||||
4372|NCT02263131|Secondary|GMR of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)||||||
4373|NCT02263131|Secondary|GMT of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)||||||
4374|NCT02263131|Secondary|Physical Examination Finding, Vital Signs||Day28(+7)||||||
4375|NCT02263131|Primary|Percentage of Subjects Achieving Seroconversion and Seroprotection for HI Antibody After Administration of the Study Vaccine|Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2), * Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40|up to Day28(+7)|||percentage of participants||95% Confidence Interval|Number
4376|NCT02263131|Primary|Solicited Local & General Adverse Event, Unsolicited Adverse Event|Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia|up to Day28(+7)|||percentage of paticipants||95% Confidence Interval|Number
4377|NCT02263118|Secondary|Mean Change in Weight-for-Age Z-score|"We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.~We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies."|Baseline at December 2013 and 23 weeks later in May 2014|||z-score||95% Confidence Interval|Mean
4378|NCT02263118|Secondary|Number of Text-messages Exchanged in Virtual Communities|We were interested in the activity of virtual communities in terms of sent text-messages.|December 2013 - May 2014, 23 weeks|"In virtual communities, participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the hybrid setup, participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional."||Number of text messages|||Number
4379|NCT02263118|Secondary|Qualitative Nature of Health-related Text-messages|Specifically, we were interested in classifying individual text-messages as social support or health related.|December 2013 - May 2014, 23 weeks|||Number of text messages|Participants||Number
4380|NCT02263118|Primary|Number of Participants With Changes in Knowledge|Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).|December 2013 - May 2014, 23 weeks|||participants|||Number
4381|NCT02262754|Secondary|Plasma Concentration of Naproxen|Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||ng/mL||Standard Deviation|Mean
4382|NCT02262754|Secondary|Plasma Concentration of PF-06372865|Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||ng/mL||Standard Deviation|Mean
4383|NCT02262754|Secondary|Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4|Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.|Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||participants|||Number
4384|NCT02262754|Secondary|Patient Global Impression of Change (PGI-C) Score|PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||90% Confidence Interval|Least Squares Mean
4385|NCT02262754|Secondary|Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4|Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||90% Confidence Interval|Least Squares Mean
4386|NCT02262754|Secondary|Chronic Low Back Pain (CLBP) Responder Index Analysis|Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.|Week 1, 2, 3, 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
4387|NCT02262754|Secondary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4|This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.|Baseline, Week 2, Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||Standard Deviation|Mean
4388|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||units on a scale||90% Confidence Interval|Mean
4389|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 1, 2, 3|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||Standard Deviation|Mean
4390|NCT02262754|Secondary|Amount of Rescue Medication Used by the Participants|The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||mg||Standard Deviation|Mean
4391|NCT02262754|Secondary|Number of Days Participants Used the Rescue Medication|The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||days||Standard Deviation|Mean
4392|NCT02262754|Secondary|Number of Participants Using Rescue Medication|Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||participants|||Number
4393|NCT02262754|Secondary|Time to Withdrawal Due to Lack of Efficacy|"Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as Insufficient Clinical Response. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization."|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||days||90% Confidence Interval|Median
4394|NCT02262754|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy|Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
4395|NCT02262754|Secondary|Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
4396|NCT02262754|Secondary|Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||percent change||Standard Deviation|Mean
4397|NCT02262754|Secondary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."||units on a scale||90% Confidence Interval|Least Squares Mean
4398|NCT02262754|Primary|Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit|PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.|End of treatment (Day 30), follow-up (Day 44)|Safety analysis set included all participants who received at least 1 dose of study treatment.||units on a scale||90% Confidence Interval|Least Squares Mean
4399|NCT02262754|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior =3 (“Yes” on “preparatory acts or behavior”), suicidal ideation =4 (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Screening, Baseline, Week 1, 2, 3, 4|Data was not collected for this outcome measure as per study team’s decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.|||||
4400|NCT02262754|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Follow-up (44 days)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, n signifies the number of participants evaluable for the specific category."||participants|||Number
4401|NCT02262754|Primary|Number of Participants With Vital Sign Abnormalities|Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Baseline up to Follow-up (44 days)|Safety analysis set included all participants who received at least 1 dose of study treatment.||participants|||Number
4402|NCT02262754|Primary|Number of Participants With Laboratory Abnormalities|Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).|Baseline up to 28 days after the last dose of study treatment (Day 56)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."||participants|||Number
4403|NCT02262754|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 28 days after the last dose of study treatment (Day 56)|Safety analysis set included all participants who received at least 1 dose of study treatment.||participants|||Number
4404|NCT02262754|Primary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4|Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.||units on a scale||90% Confidence Interval|Mean
4405|NCT02262728|Secondary|Percentage of Participants With SVR12 Who Maintain to Have HCV RNA <LLOQ Until the End of 5 Years Follow up|Percentage of participants with SVR12 who continue to have HCV RNA <LLOQ (15 IU/mL) will be reported after the completion of the follow-up phase.|Week 24 up to Week 276||01/2021||||
4406|NCT02262728|Secondary|Percentage of Participants With Viral Relapse|Viral relapse is defined as participants who do not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ (15 IU/mL) at Week 16, 24 or 36.|Week 16, 24 and 36|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint (viral relapse) analysis was zero.|||||
4407|NCT02262728|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
4408|NCT02262728|Secondary|Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The C0h is the pre-dose plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
4409|NCT02262728|Secondary|Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmin is the minimum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||ng/mL||Standard Deviation|Mean
4410|NCT02262728|Secondary|Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmax is the maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||nanogram per Millilieters (ng/mL)||Standard Deviation|Mean
4411|NCT02262728|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||ng.h/mL||Standard Deviation|Mean
4412|NCT02262728|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|Tmax is the time to reach maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.||Hours||Full Range|Median
4413|NCT02262728|Secondary|Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)||Follow-up Week 24 (Week 36)|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units per Liter (U/L)||Standard Deviation|Mean
4414|NCT02262728|Secondary|Percentage of Participants With HCV NS3/4A Sequence, NS5A and NS5B After End of Treatment in Participants Not Achieving SVR|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. All subjects in this study achieved SVR12. Therefore, reasons for not achieving SVR12 are not applicable.|Baseline, Day 3, Week 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and Year 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 after end of treatment|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint analysis was zero.|||||
4453|NCT02259400|Secondary|Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)||first week of life|||participants|||Number
4454|NCT02259400|Secondary|Retinopathy of Prematurity (ROP)||3 month of life|||participants|||Number
4415|NCT02262728|Secondary|Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)|Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was <LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.|Week 16 and Week 36|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here , 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Percentage of Participants||95% Confidence Interval|Number
4416|NCT02262728|Secondary|Percentage of Participants With On-Treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: <LLOQ undetectable, <LLOQ detectable, and <LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment.|Week 1, 2, 4, 6, 8, 10, 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Percentage of Participants|||Number
4417|NCT02262728|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.|Week 24|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
4418|NCT02262078|Primary|Change in Pulmonary Capillary Wedge Pressure During Exercise|Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured in millimeters of mercury (mmHg)|Baseline, after study drug dosing, approximately 4 minutes after starting exercise|||millimeters of mercury||Standard Deviation|Mean
4419|NCT02262039|Secondary|Mean ETCO2|mean End-tidal carbon dioxide concentration in the expired air|intraoperative|||mmHg||Standard Deviation|Mean
4420|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|12 hours post-op|||units on a scale||Standard Deviation|Mean
4421|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.|6 hours post-op|||units on a scale||Standard Deviation|Mean
4422|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|1 hour post-op|||units on a scale||Standard Deviation|Mean
4423|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalent - mean in mg|Operative and Post-operative|||mg||Standard Deviation|Mean
4424|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Post-operative|||mg||Standard Deviation|Mean
4425|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Intra-Operative on day of surgery|||mg||Standard Deviation|Mean
4426|NCT02261948|Secondary|Change in DLCO (Diffusion Lung CO)|Levosimendan induced changes on DLCO ( Diffusion Lung CO). DLCO is measured by the single breath-constant expiratory flow technique (Sensor Medics 2200, Yorba Linda, CA) and we calculate also the DLCO adjusted for hemoglobin. Dilution of CH4 is used to measure alveolar volume.|48 hours|||ml/mmHg/min||Standard Deviation|Mean
4427|NCT02261948|Secondary|Changes in VE/VCO2|Levosimendan induced changes on VE/VCO2 (VE: Expired Volume - VCO2: carbon dioxide production) relationship|48 hours|||VE/VCO2 Slope||Standard Deviation|Mean
4428|NCT02261948|Primary|Change in Peak VO2 (Oxygen Consumption )|Primary endpoints: Levosimendan induced changes in peak VO2 (Oxygen consumption )|48 hours|||ml/kg/min||Standard Deviation|Mean
4429|NCT02261428|Secondary|Presence of Blood on Catheter Immediately After Each Intervention|Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).|Within 2 seconds after catheter withdrawal.|||Catheters with presence of blood|||Number
4430|NCT02261428|Secondary|Diastolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the diastolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.|||mmHg||Standard Deviation|Mean
4431|NCT02261428|Secondary|Systolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the systolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.|||mmHg||Standard Deviation|Mean
4432|NCT02261428|Secondary|Heart Rate Immediately After Intervention|Immediately after each intervention recorded the heart rate (beats per minute).|Within 2 seconds after catheter withdrawal.|||Βeats per minute||Standard Deviation|Mean
4433|NCT02261428|Secondary|Respiratory Rate Immediately After Intervention|Recorded the respiratory rate (breaths per minute), immediately after intervention|Within 2 seconds after catheter withdrawal.|||Βreaths per minute||Standard Deviation|Mean
4434|NCT02261428|Secondary|Time to Entering Trachea|We count the required time needed to insert catheter into trachea (seconds).|An average of 15 seconds|The 19 interventions with each catheter was used randomly||Sec||Standard Deviation|Mean
4435|NCT02261428|Primary|Number of Attempts Before Entering Trachea|We count the required attempts to insert catheter into trachea (number of attempts)|An average of 15 seconds|||Attempts||Standard Deviation|Mean
4436|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Fatigue|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4455|NCT02259400|Secondary|Periventricular Leukomalacia (PVL)||3 month of life|||participants|||Number
4437|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Headache|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4438|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Arthralgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4439|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Myalgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4440|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Pyrexia|Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4441|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Pain|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4442|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Swelling|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4443|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Erythema|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.||Percentage of participants|||Number
4444|NCT02260882|Secondary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after primary vaccination|Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
4445|NCT02260882|Primary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after revaccination|Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window.||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
4446|NCT02259608|Secondary|Cytokine Production Measured by ELISA Compared to Baseline|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens|0 weeks and 2 weeks|||ratio||Full Range|Mean
4447|NCT02259608|Primary|Cytokine Production Measured by ELISA Compared to Baseline|"Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination.~Baseline is set as 1."|0 weeks and 3 months|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens||ratio||Full Range|Mean
4448|NCT02259400|Secondary|Death||1 month|||participants|||Number
4449|NCT02259400|Secondary|Late Onset Sepsis||after fifth days of life up 2 month of life|||participants|||Number
4450|NCT02259400|Secondary|Early Onset Sepsis||5days from birth|||participants|||Number
4462|NCT02259348|Post-Hoc|Median Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation|||days||Full Range|Median
4463|NCT02259348|Post-Hoc|Mean of Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation|||days||Standard Deviation|Mean
4464|NCT02259348|Secondary|Rate of Transplant-related Mortality (TRM)|The cumulative incidence of transplant related mortality will be estimated using Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the competing risk events.|100 days post transplantation|All six participants who received the protocol-defined treatment were evaluable for this analysis. One participant died of a non-transplant related cause (leukemia) prior to day 100. Although this participant did not complete the study to Day 100 post-transplantation, they were still evaluable for TRM.||participants|||Number
4465|NCT02259348|Secondary|Incidence and Severity of Chronic GvHD|"The cumulative incidence of chronic GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of chronic GvHD will be described. Chronic GvHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with incidence by severity is given."|one year post transplantation|||participants|||Number
4466|NCT02259348|Secondary|Incidence and Severity of Acute GvHD|The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|100 days post transplantation|Two of six participants did not experience any acute GvHD.||participants|||Number
4467|NCT02259348|Secondary|Overall Survival (OS)|The Kaplan-Meier estimate of OS along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) – date of transplant and all participants surviving at the time of analysis without events will be censored. The number of participants surviving to one-year post-transplantation is given.|one year post transplantation|||participants|||Number
4468|NCT02259348|Secondary|Event-free Survival (EFS)|The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) – date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.|one year post transplantation|||participants|||Number
4469|NCT02259348|Secondary|Incidence of Malignant Relapse|The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The number of participants with incidence of malignant relapse is given. Relapse was evaluated using standard WHO criteria for each disease.|one year post transplantation|||participants|||Number
4470|NCT02259348|Primary|Percentage of Participants Engrafted by Day 42 Post-transplant|To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation|||percentage of participants|||Number
4471|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.|Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.|4 weeks|33 subjects completed the 4 week study.||percentage of days in a week||Standard Deviation|Mean
4472|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.|"Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.~Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose."|4 weeks|33 subjects completed the 4 week study.||percentage of days in a week||Standard Deviation|Mean
4473|NCT02258477|Primary|Responses to the Control of Eating Questionnaire|"Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked what one food makes it most difficult for you to control eating? and question #10 asked  What time are you particularly vulnerable to this one food. Higher ratings are consistent with a more significant or more frequent outcome.~Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order)."|4 weeks|33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.||units on a scale||Standard Deviation|Mean
4508|NCT02256072|Secondary|Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months|Overall satisfaction with the intervention or attention control as measured by the “Satisfaction with Intervention Tool.” Tests will be performed at a two-sided 5% significance level.|baseline, post-intervention, 1 month, and 3 months|Due to errors in the data collection method, it is not possible to summarize the data for reporting.|||||
4474|NCT02258334|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine|Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.||Titer ratios||95% Confidence Interval|Geometric Mean
4475|NCT02258334|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
4476|NCT02258334|Secondary|Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
4477|NCT02258334|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.|Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
4478|NCT02258334|Primary|Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
4479|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
4480|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
4481|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.|||||
4482|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
4483|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
4484|NCT02257918|Secondary|Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.||µg/mL||Full Range|Median
4485|NCT02257918|Secondary|The Proportion of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
4486|NCT02257918|Secondary|The Proportion of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
4487|NCT02257918|Secondary|The Proportion of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 6|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
4488|NCT02257918|Secondary|The Proportion of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 1 (Baseline)|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.||Participants|||Count of Participants
4489|NCT02257918|Secondary|The Proportion of Participants With Clinical Cure in Each Study Arm|A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator’s assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator’s assessment was the final adjudicator.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.||Participants|||Count of Participants
4490|NCT02257918|Secondary|The Proportion of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.||Participants|||Count of Participants
6209|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
4491|NCT02257918|Secondary|The Proportion of Participants With Microbiological Cure at Rectal Sites in Each Study Arm|Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.||Participants|||Count of Participants
4492|NCT02257918|Primary|The Proportion of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.|Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.|Day 1 through Day 31|All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.||Participants|||Count of Participants
4493|NCT02257918|Primary|The Proportion of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.||Participants|||Count of Participants
4494|NCT02257385|Secondary|Change From Baseline in Weighted Mean (WM) FEV1 Over 0-6 Hour Post-dose at Day 84|BL FEV1 was the mean of the 2 assessments made 30 and 5 min PD on Day 1. WM FEV1 derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1 and 84 using the 0-6 hr post-dose FEV1 measurements collected on that day, which included PD FEV1 (taken 30 and 5 min prior to dosing on Day 1 and the 30 and 5 min reading prior to dosing on Day 84) and post-dose FEV1 measurements at 1, 3 and 6 hr post-dose.WM change from BL was the WM at at the visit minus the BL value. Analysis was performed using a RM model with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1) center group, day, day by BL and day by trt interaction, where day was nominal. Only par with data available at the specified TP were analyzed but all par w/o missing covariate information and with >=1 post-BL measurement were included in the analysis.|Baseline and Day 84|ITT Population||Liters||Standard Error|Least Squares Mean
4495|NCT02257385|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the 2 assessments made 30 and 5 minutes (min) pre-dose (PD) on Day 1. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after dosing on Day 84 (at Week 12 + 1 day). Analysis was performed using mixed model repeated measures (RM) with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1), center group, day, day by BL interaction and day by trt interaction, where day was nominal.|Baseline (BL) and Day 85|Per Protocol (PP) Pop: all ITT Pop par who were not full protocol deviators considered to impact efficacy. Only par with data available at the specified time points (TP) were analyzed but all par without (w/o) missing covariate information and with >= 1 post BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
4496|NCT02257372|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated by performing six-hour serial spirometry from the pre-dose FEV1 and post-dose FEV1 measurements at 15 minutes, 30 minutes, 1 hour, 3 hours and 6 hours. Baseline FEV1 is the mean of the two assessments made 30 and 5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as weighted mean value on Day 84 minus the Baseline value. Analysis was performed using mixed model repeated measures with covariates of treatment, baseline FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA , smoking status, Day, Day by baseline interaction and Day by treatment interaction, where Day is nominal.|Baseline and Day 84|ITT population||Liter||Standard Error|Least Squares Mean
4497|NCT02257372|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 was measured using spirometry. BL FEV1 is the mean of the two assessments made 30 and 5 minutes (min) pre-dose on Day 1.Change from BL was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis was performed using mixed model repeated measures with covariates of treatment, BL FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA, smoking status, Day, Day by BL interaction and Day by treatment interaction, where Day is nominal.|Baseline (BL) and Day 85|Intent-to-treat (ITT) population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only participants with data available at specific timepoint were analyzed.||Liter||Standard Error|Least Squares Mean
4498|NCT02256982|Primary|Number of Participants Post Operative/Radiation Therapy Complications|Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.|90 Days|||participants|||Number
11610|NCT01976806|Secondary|Serum High-sensitivity Interleukin-6|Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.|Baseline and 3 months||||||
4499|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
4500|NCT02256553|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, was also an AE.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
4501|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
4502|NCT02256553|Primary|Percentage of Participants Who Experienced at Least One Event of Local Swelling|Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
4503|NCT02256488|Secondary|Number of Subjects With Unsolicited Adverse Events|Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.|Day 1 through day 22|Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination.||Subjects|||Number
4504|NCT02256488|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.|Day 1 through day 7 (without 30 min)|Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination||Subjects|||Number
4505|NCT02256488|Secondary|Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.|"Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).~Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.~HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.~According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%."|Day 22|FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed “as randomized” (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).||percentages of subjects||95% Confidence Interval|Number
4506|NCT02256488|Primary|Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.|Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.|Day 22|Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis.||Titers||95% Confidence Interval|Geometric Mean
4507|NCT02256358|Primary|Emergence Agitation|The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.|During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes|||participants|||Number
4509|NCT02256072|Secondary|Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months|Knowledge of home services score at all follow-up time points as measured by “Understanding of Home Services” assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.||units on a scale||Standard Deviation|Mean
4510|NCT02256072|Secondary|Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months|Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.||units on a scale||Standard Deviation|Mean
4511|NCT02256072|Secondary|Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months|Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the “Planning Perception” assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning perception score at post-intervention, one and three months while controlling for baseline planning perception score. All analyses will assume a type I error rate of 5%.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.||units on a scale||Standard Deviation|Mean
4512|NCT02256072|Primary|Planning Behavior Score at 1-month|The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the “Planning Implementation (Behavior)” assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.|baseline and 1 month|All randomized participants with a complete planning behavior score at baseline and one-month.||units on a scale||Standard Deviation|Mean
4513|NCT02255279|Secondary|Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.||Percentage of subjects||95% Confidence Interval|Number
4514|NCT02255279|Secondary|Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to <72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.||Ratios||95% Confidence Interval|Geometric Mean
4515|NCT02255279|Secondary|Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.||Percentages of subjects||95% Confidence Interval|Number
4516|NCT02255279|Primary|Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.|"Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.~The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007)."|Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination|Analysis performed on the Per Protocol Set.||Titers||95% Confidence Interval|Geometric Mean
4517|NCT02255279|Primary|Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22|Number of non-naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.|From Day 1 to Day 22|Analysis performed on the Unsolicited Safety Set.||Participants|||Number
4518|NCT02255279|Primary|Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.|Number of naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.|From Day 1 to Day 50|Analysis performed on the Unsolicited Safety Set.||Participants|||Number
4519|NCT02255279|Primary|Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of non-naive subjects ≥36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.||Participants|||Number
6237|NCT02170077|Primary|"The Proportion of Patients With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as Responders) in a Treatment Period Compared to the Baseline Period"||baseline, week 12|||percentage of responders|||Number
4520|NCT02255279|Primary|Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects ≥ 36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.||Participants|||Number
4521|NCT02255279|Primary|Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.|Number of non-naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.||Participants|||Number
4522|NCT02255279|Primary|Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.||Participants|||Number
4523|NCT02255149|Primary|Bone Height|Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.|5 months|||millimeters||Full Range|Mean
4524|NCT02254551|Secondary|Overall Response|Number of patients with confirmed Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Progressive Disease (PD) or Stable Disease (SD) according to International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=5% or less plasma cells in bone marrow, disappearance of soft tissue plasmacytoma, negative immunofixation on serum and urine. VGPR=Serum and urine M-protein detectable by immunofixation but not by electrophoresis, disappearance of any soft tissue plasmacytomas that were present at baseline. PR= at least 50% reduction from baseline in serum M-protein and at least 90% reduction from baseline in 24hr urinary M-protein. PD=Increase of 25% or more from nadir in serum or urine proteins. SD= not meeting criteria for CR, VGPR, PR or PD.|Every 3 weeks up to 48 weeks|Of 7 enrolled patients, 1 was deemed ineligible and was excluded from efficacy analyses. At a median follow-up of 6 weeks, 3 patients in Cohort 1 had progressive disease and 3 had stable disease. Study was terminated after reviewing data from this first lead-in cohort.||Participants|||Count of Participants
4525|NCT02254551|Primary|Time to Disease Progression|Time to progression (TTP) is measured from Day 1 of study drug administration to disease progression using International Myeloma Working Group (IMWG) Uniform Response Criteria.|every 3 weeks up to 48 weeks, then every 3 months thereafter up to 3 years from initiation of study treatment.|This outcome measure was to be assessed during the expansion phase of the study. The study closed early and did not proceed to this phase of the study. There is no data to report for this outcome measure.|||||
4526|NCT02254551|Primary|Maximum Tolerated Dose (MTD) of LDE225 Plus Bortezomib|During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.|every 3 weeks up to 48 weeks||||||Number
4527|NCT02254252|Secondary|Side-effects|Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications|1 month||||||
4528|NCT02254252|Primary|Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris|One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient’s description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).|1 month|||participants|||Number
4529|NCT02254252|Primary|Angina Episode Intensity|One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.|1 month|||units on a scale||Standard Deviation|Mean
4530|NCT02254252|Primary|Angina Episode Frequnecy|One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.|1 month|||episodes per week||Standard Deviation|Mean
4531|NCT02253160|Secondary|MNC Product Contamination/Purity - RBC Concentration (10^6/µL)||within 5 minutes upon completion of procedure|||RBC*10^6/µL||Standard Deviation|Mean
4532|NCT02253160|Secondary|MNC Collection Efficiency (CE2%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|||percent||Standard Deviation|Mean
4533|NCT02253160|Other Pre-specified|Post-collection Platelet Loss in Subject|The percent change from pre-collection platelet count to post-collection subject platelet count.|24-hours after last collection procedure|||percent change||Standard Deviation|Mean
4534|NCT02253160|Other Pre-specified|Device Deficiencies|Any time a device or disposable does not function as described in the Operator’s Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.|24-hours after last collection procedure|All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.||events|||Number
4535|NCT02253160|Secondary|Procedure Time (Minutes)||within 5 minutes upon completion of procedure|||minutes||Standard Deviation|Mean
12427|NCT01958346|Primary|Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.||At Intubation|||participants|||Number
4536|NCT02253160|Secondary|Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)|A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.|within 5 minutes upon completion of procedure|Five collections also collected plasma for this sub-study.||cells*10^3/µL||Standard Deviation|Mean
4537|NCT02253160|Secondary|MNC Blood Product Volume (mL)|The produced unit of MNCs collected into the blood bag.|within 5 minutes upon completion of procedure|||mL||Standard Deviation|Mean
4538|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.||percent||Standard Deviation|Mean
4539|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)||within 5 minutes upon completion of procedure|||cells*10^3/µL||Standard Deviation|Mean
4540|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)||within 5 minutes upon completion of procedure|||cells*10^3/mL||Standard Deviation|Mean
4541|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Hematocrit (%)||within 5 minutes upon completion of procedure|||% of red blood cells||Standard Deviation|Mean
4542|NCT02253160|Secondary|CD34+ Per kg of Body Weight||within 5 minutes upon completion of procedure|||cells/kg||Standard Deviation|Mean
4543|NCT02253160|Secondary|MNC Collection Efficiency (CE1%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.||percent||Standard Deviation|Mean
4544|NCT02253160|Secondary|CD34+ Collection Efficiency (CE2 %)|Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|||percent||Standard Deviation|Mean
4545|NCT02253160|Primary|CD34+ Collection Efficiency (CE1 %)|The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|||percent||Standard Deviation|Mean
4546|NCT02252965|Secondary|Percentage of Subjects Who Are Compliant to Treatment|Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects|||Number
4547|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)|Percentage of subjects with HbA1c <7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.||percentage of subjects||95% Confidence Interval|Number
4548|NCT02252965|Secondary|Percentage of Subjects Who Are Totally Intolerant to the Treatment|Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
4549|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7%||Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.||percentage of subjects||95% Confidence Interval|Number
4550|NCT02252965|Secondary|Percentage of Subjects With Marked Hyperglycemia|Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.||percentage of subjects||95% Confidence Interval|Number
4551|NCT02252965|Secondary|Percentage of Subjects With Hypoglycemia|Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter [mmol/L]).|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
4552|NCT02252965|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16|The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.|Baseline, Week 8 and 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.||mmol/L||Standard Deviation|Mean
13737|NCT01936662|Secondary|OR to Discharge (Min)|Overall time from arrival in the OR to discharge home (in minutes)|OR to discharge|||Minutes||Standard Deviation|Mean
4553|NCT02252965|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16||Baseline, Week 1, 2, 4, 8, 12,16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.||Millimole Per Liter (mmol/L)||Standard Deviation|Mean
4554|NCT02252965|Secondary|Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
4555|NCT02252965|Primary|Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.||percentage of subjects||95% Confidence Interval|Number
4556|NCT02252965|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16||Baseline, Week 16|"Per-protocol (PP) population included all subjects who were randomly allocated to a treatment based on intent to treat and were compliant with protocol (absence of any major protocol violations). Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||Percentage of HbA1c||Standard Error|Least Squares Mean
4557|NCT02252744|Primary|Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease||1 day|||participants|||Number
4558|NCT02252445|Secondary|Analgesics|The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients infused with tramadol were counted.||participants|||Number
4559|NCT02252445|Secondary|Dizziness|Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dizziness were counted.||participants|||Number
4560|NCT02252445|Secondary|Blurred Vision|Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with blurred vision were counted.||participants|||Number
4561|NCT02252445|Secondary|Flushing|Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with flushing were counted.||participants|||Number
4562|NCT02252445|Secondary|Dry Mouth|Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dry mouth were counted.||participants|||Number
4563|NCT02252445|Secondary|Vomiting|Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with vomiting were counted.||participants|||Number
4564|NCT02252445|Secondary|Nausea|Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with nausea were counted.||participants|||Number
4565|NCT02252445|Secondary|Hemodynamic Parameters|Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.|0, 1, 5, 10 minute postoperatively|||mmHg||Standard Deviation|Mean
4566|NCT02252445|Secondary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|0, 6 and 24 hour postoperatively|Patients with score >0 will be counted.||participants|||Number
4567|NCT02252445|Primary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|1 hour postoperatively|Patients with score >0 were counted.||participants|||Number
4568|NCT02252354|Secondary|Part 2: Clearance (CL) for [14C]-TAK-385|CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L/hr||Standard Deviation|Mean
4569|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 72 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4570|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 48 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4571|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 36 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4572|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 24 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4573|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 12 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4574|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 8 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4575|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 4 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4576|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 2 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4577|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 1 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose|||Number
4578|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose||Standard Deviation|Mean
4579|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of dose||Standard Deviation|Mean
4580|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of recovered radioactivity||Standard Deviation|Mean
4581|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage of recovered radioactivity||Standard Deviation|Mean
4582|NCT02252354|Secondary|Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.|Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percent recovery of radioactivity||Standard Deviation|Mean
4583|NCT02252354|Secondary|Part 2: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L||Standard Deviation|Mean
4584|NCT02252354|Secondary|Part 1: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||Liter (L)||Standard Deviation|Mean
4585|NCT02252354|Secondary|Part 2: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L/hr||Standard Deviation|Mean
4648|NCT02249052|Primary|Reduction in Visible Surface Area of the Lipoma|"The primary efficacy outcome is lipoma visible surface area defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit."|6 months post injection|All 19 subjects enrolled with 2 lipomas. All received study drug in one lipoma and placebo in the other lipoma.||percentage change from baseline||Standard Deviation|Mean
4586|NCT02252354|Secondary|Part 1: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||L/hr||Standard Deviation|Mean
4587|NCT02252354|Primary|Part 2: Absolute Bioavailability for the Oral Tablet Formulation|Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percentage bioavailability||Standard Deviation|Mean
4588|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
4589|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
4590|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng*hr/mL||Standard Deviation|Geometric Mean
4591|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
4592|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng*hr/mL||Standard Deviation|Geometric Mean
4593|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
4594|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng/mL||Standard Deviation|Geometric Mean
4595|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq/mL||Standard Deviation|Geometric Mean
4596|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
4597|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
4598|NCT02252354|Primary|Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).|Day 1 pre-dose and various time-points (up to Day 288) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||percent recovery of radioactivity||Standard Deviation|Mean
4599|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
4600|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Standard Deviation|Mean
4601|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng*hr/mL||Standard Deviation|Geometric Mean
4602|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
4603|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
4604|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq*hr/mL||Standard Deviation|Geometric Mean
4605|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
4606|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||ng eq/mL||Standard Deviation|Geometric Mean
4607|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
4608|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration.||hours||Full Range|Median
4666|NCT02248766|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 week, 2 week, 4 week|||logMar||Standard Deviation|Mean
4609|NCT02252133|Primary|Success Rate of Lens Centration After 7 ± 2 Days of Wear|Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as “optimal” or “slight decentration. One eye (study eye) was analyzed.|Day 7, each product|This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.||percentage of subjects|||Number
4610|NCT02252016|Secondary|Percentage of Participants in the Immediate Treatment Group Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|The percentage of participants in the Immediate Treatment arm achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|24 weeks after completing study therapy (Week 36)|Analysis of SVR24 data is ongoing. Results will be presented in a future report.|||||
4611|NCT02252016|Primary|Number of Participants Discontinuing From Study Treatment Due to an AE(s)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.||Participants|||Number
4612|NCT02252016|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All-Participants-as-Treated (APaT) population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.||Participants|||Number
4613|NCT02252016|Primary|Percentage of Participants in the Immediate Treatment Group Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|The percentage of participants in the Immediate Treatment arm achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|12 weeks after completing study therapy (Week 24)|The modified Full Analysis Set (mFAS) consists of all treated participants in the Immediate Treatment arm other than those who discontinued with reasons unrelated to the treatment regimen or HCV response.||Percentage of participants||95% Confidence Interval|Number
4614|NCT02251886|Primary|Version of Fetal Breech Position to Cephalic Position|Number of Participants with Version of Fetal Breech Position to Cephalic|4 weeks|||participants with fetus in breech|||Number
4615|NCT02251613|Secondary|Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).|Day 1, 20 minutes post-CAC|This analysis population includes all randomized participants.||units on a scale|Participants|Standard Deviation|Mean
4616|NCT02251613|Primary|Mean Ocular Itching at 7 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).|Day 1, 7 minutes post-CAC|This analysis population includes all randomized participants.||units on a scale|Participants|Standard Deviation|Mean
4617|NCT02251561|Secondary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.||percentage of participants|||Number
4618|NCT02251561|Primary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.||percentage of participants|||Number
4619|NCT02250807|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ.|Up to follow-up week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
4620|NCT02250807|Secondary|Percentage of Participants With Viral Breakthrough|Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ.|Up to follow-up Week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
4621|NCT02250807|Secondary|Percentage of Participants With On-Treatment Failure|Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., <LLOQ detectable or >=LLOQ.|through 12 weeks (EOT)|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
4622|NCT02250807|Secondary|Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed.|Week 2, 3, 4, 12 and EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants|||Number
4623|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)|Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable.|At 24 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants||95% Confidence Interval|Number
4624|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)|SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT.|4 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants||95% Confidence Interval|Number
4625|NCT02250807|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)|SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.|12 weeks after EOT|Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).||percentage of participants||95% Confidence Interval|Number
4626|NCT02250274|Secondary|Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)||Day 7|There were too few samples collected within each group to conduct a reasonable analysis of this outcome. The samples collected are being stored for potential future use.|||||
4627|NCT02250274|Secondary|Antibody Dependent Cellular Cytotoxicity (ADCC) Titers||Change from Baseline to 28 days||12/2016||||
4628|NCT02250274|Secondary|Polymerase Chain Reaction (PCR) Confirmed Influenza Illness||Onset >13 days after vaccination and before April 1, 2015|||participants|||Number
4629|NCT02250274|Primary|Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza||Change from Baseline to 28 days|||Titers||95% Confidence Interval|Geometric Mean
4630|NCT02249728|Secondary|Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)|area under the plasma concentration vs time curve to the last timepoint|0 to 72 hours|PK Population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
4631|NCT02249728|Secondary|Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours|Ratio of whole blood, plasma [14C] PBT2 at 24 hours|0 to 24 hours|PK population||ratio [14C] PBT2||Geometric Coefficient of Variation|Geometric Mean
4632|NCT02249728|Secondary|Safety and Tolerability of PBT2|As assessed by the number of participants with adverse events|72 h post oral dose|Safety Population||participants|||Number
4633|NCT02249728|Secondary|Oral PK Profile of PBT2 as Assessed by AUC(0-last)|Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .|72 h post oral dose|||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
4634|NCT02249728|Secondary|IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)|Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .|0 to 72 h post oral dose|PK Population||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
4635|NCT02249728|Primary|Mass Balance|Amount excreted as a percentage of the administered dose (%Ae)|168 h (7 days) post dose|PK Population||percentage of administered dose||Standard Deviation|Geometric Mean
4636|NCT02249728|Primary|Absolute Bioavailability of PBT2 (F%)|Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).|0 to 72 hours post oral dose|PK Population||percentage of absolute bioavailability||Standard Deviation|Mean
4637|NCT02249104|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks|||Percent change||Standard Deviation|Mean
4638|NCT02249104|Secondary|Percent Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks|||Percent change||Standard Deviation|Mean
4639|NCT02249104|Secondary|Mean Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks|||Lesions counted||Standard Deviation|Mean
4640|NCT02249104|Secondary|Mean Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks|||Lesions counted||Standard Deviation|Mean
4641|NCT02249104|Secondary|Percent Change From Baseline in Total Lesion Count||Baseline and 8 weeks|||Percent change||Standard Deviation|Mean
4642|NCT02249104|Primary|Mean Change From Baseline in Total Lesion Count||Baseline and 8 weeks|||Lesions counted||Standard Deviation|Mean
4643|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|3 month post injection|All 19 subjects enrolled with 2 lipomas. All received study drug in one lipoma and placebo in the other lipoma.||percentage of reduction from baseline||Standard Deviation|Mean
4644|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|1 Month post injection|All 19 subjects enrolled with 2 lipomas. All received study drug in one lipoma and placebo in the other lipoma.||percentage of reduction from baseline||Standard Deviation|Mean
4645|NCT02249052|Secondary|Subject Satisfaction|Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire|6 months|1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants||participants satisfied|||Number
4646|NCT02249052|Secondary|Greatest Dimension (Length) of Lipoma|Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with study drug and the lipoma treated with placebo.|6 months|All study participants||Percent change from baseline||Standard Deviation|Mean
4647|NCT02249052|Secondary|Responder Analysis|The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline|6 months|All 19 participants||participants|||Number
6278|NCT02169115|Secondary|To Assess the Safety of Omalizumab in UF Patients|Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|112 days||||||
4649|NCT02248818|Other Pre-specified|EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction|EEG parameter (DAY 12) - Gamma - Change from baseline (pre 1st dose of investigational product) in Total Area of the Brain (eyes closed) Cohort 5 & 7 , Cohort 6 did not reach Day 12|8 hours after dose|Safety population||uV2||Standard Deviation|Mean
4650|NCT02248818|Other Pre-specified|EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 6) - Gamma - Change from baseline (pre 1st dose of investigational product) in Total Area of the Brain (eyes closed) Cohort 5 & 7, Cohort 6 did not reach Day 6|8 hours after dose|Safety population||uV2||Standard Deviation|Mean
4651|NCT02248818|Other Pre-specified|EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 1) - Gamma - Change from baseline (pre 1st dose of investigational product) in Total Area of the Brain (eyes closed|8 hours after dose|Safety population||uV2||Standard Deviation|Mean
4652|NCT02248818|Secondary|Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD|Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 & 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]|Day 12 compared to Day 1|Pharmacokinetic population, MAD Cohorts 5 & 7||ratio||Standard Deviation|Mean
4653|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose|Pharmacokinetic population (subjects dosed with AZD8108)||hours||Full Range|Median
4654|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed||Percent||Geometric Coefficient of Variation|Geometric Mean
4655|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)|Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed||Percent|Participants with urine volume data|Geometric Coefficient of Variation|Geometric Mean
4656|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic population (subjects dosed with AZD8108)||hours||Full Range|Median
4657|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7||ng/mL||Geometric Coefficient of Variation|Geometric Mean
4658|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7||ng/mL||Geometric Coefficient of Variation|Geometric Mean
4659|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
4660|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 & 7, Cohort 6 dod not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
4661|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
4662|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
4663|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108|Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
4664|NCT02248818|Primary|Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal|Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal|Day -1 to 7 days after last dose|Safety population||Participants|||Number
4665|NCT02248766|Primary|Subjective Assessments- Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)|Baseline, 1 week, 2 week, 4 week|||units on a scale||Standard Deviation|Mean
4667|NCT02248727|Primary|Subjective Assessments. - Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)|Baseline, 1 Week, 2 Week, 4 Week|||units on a scale||Standard Deviation|Mean
4668|NCT02248727|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 Week, 2 Week, 4 Week|||logMar||Standard Deviation|Mean
4669|NCT02248558|Secondary|Cost-effectiveness of Developing HIV Testing Promotional Videos|Cost-effectiveness of developing the crowdsourced video compared to the conventional video|Up to one year|||USD|||Number
4670|NCT02248558|Secondary|Likelihood of HIV Testing|"All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be very unlikely, 1 will be unlikely, 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported."|Up to one day|||Participants|||Count of Participants
4671|NCT02248558|Primary|First-Time HIV Testing|All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.|Up to 4 weeks following the video intervention|||Participants|||Count of Participants
4672|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4673|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4674|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4675|NCT02248480|Secondary|Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria|A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||percentage of participants|||Number
4676|NCT02248480|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||percentage of participants|||Number
4677|NCT02248480|Secondary|Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4903|NCT02231918|Secondary|Number of Patients With Drug Related Adverse Events|Number of patients with adverse events due to study drug.|From first drug administration until 24 hours after last study drug administration, upto 48 days|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.||participants|||Number
4678|NCT02248480|Secondary|Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.|Baseline,Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||percentage of participants|||Number
4679|NCT02248480|Secondary|Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4680|NCT02248480|Secondary|Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
4681|NCT02248480|Secondary|Change From Baseline on the Patient Global Assessment Illness (PGAI) Score||Baseline, Week 14|Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced.|||||
4682|NCT02248480|Secondary|Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4683|NCT02248480|Secondary|Percentage of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
4684|NCT02248480|Secondary|Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score|Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach’ including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
4685|NCT02248480|Secondary|Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)|36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) − min{raw score}] / (max {raw score} − min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
4686|NCT02248480|Secondary|Change From Baseline on the Clinical Global Impression of Severity (CGI-S)|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4972|NCT02229864|Secondary|All Target Vessel Revascularization (TVR)||0 to 208 Days|||percentage of participants|||Number
4687|NCT02248480|Secondary|Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)|Patient’s Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4688|NCT02248480|Primary|Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4689|NCT02248246|Secondary|Percentage of Participants With Hemostasis at the IMV|Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). “Yes” is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.|Intraoperatively|Safety Set - all subjects in whom the procedure was started.||percentage of participants||95% Confidence Interval|Number
4690|NCT02248246|Primary|Percentage of Participants With Hemostasis at the IMA|Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). “Yes” is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.|Intraoperatively|Safety Set - all subjects in whom the procedure was started.||percentage of subjects||95% Confidence Interval|Number
4691|NCT02248103|Secondary|Bone Defect Area|linear measurements collected from a digital radiography program to estimate percentage of defect fill.|Baseline and 6 months|||"mm^2"||Standard Deviation|Mean
4692|NCT02248103|Secondary|Pocket Depth|Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months|||mm||Standard Deviation|Mean
4693|NCT02248103|Primary|Clinical Attachment Level|Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months|defects||mm||Standard Deviation|Mean
4694|NCT02247011|Primary|Serum Creatinine|Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.|5 years|||umol/l||Standard Error|Mean
4695|NCT02247011|Primary|Serum Alkaline Phosphatase|Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.|5 years|||U/L||Standard Deviation|Mean
4696|NCT02247011|Primary|Biochemical Markers|Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.|5 year|||mmol/L||Standard Deviation|Mean
4697|NCT02247011|Primary|Bone Turnover Markers and 25(OH)D|C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)|5 year|||ng/ml||Inter-Quartile Range|Median
4698|NCT02247011|Primary|Bone Mineral Density|bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)|5 year|||g/cm^2||Inter-Quartile Range|Median
4699|NCT02247011|Primary|Vertebral Fracture Incidence|Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)|5 year|||participants|||Number
4700|NCT02247011|Primary|Non-vertebral Fracture Incidence|Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).|5 year|In 1100 participants, 975 of them finished the questionnaire||participants|||Number
4701|NCT02246582|Secondary|Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)|Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.||percentage||Standard Deviation|Mean
4702|NCT02246582|Secondary|Retrospective Re-Analysis (MARD With 1 Additional Calibration)|Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.||percentage||Standard Deviation|Mean
4712|NCT02246166|Secondary|Global Assessment of Treatment|After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: “How well did the test medication control your symptoms?” (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Participants|||Number
4703|NCT02246582|Primary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)|Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.||percentage||Standard Deviation|Mean
4704|NCT02246166|Secondary|Body Temperature Reduction|Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||°C (degree Celsius)||Standard Error|Least Squares Mean
4705|NCT02246166|Secondary|Cough Severity Assessment|Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4706|NCT02246166|Secondary|Sneezing Severity Assessment|Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4707|NCT02246166|Secondary|Runny Nose Severity Assessment|Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4708|NCT02246166|Secondary|Nasal Congestion Severity Assessment|Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4709|NCT02246166|Secondary|Extremities Pain Severity Assessment|Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4710|NCT02246166|Secondary|Headache Severity Assessment|Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4711|NCT02246166|Secondary|Sore Throat Severity Assessment|Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4973|NCT02229864|Secondary|All Target Lesion Revascularization (TLR)||0 to 208 Days|||percentage of participants|||Number
4974|NCT02229864|Secondary|All Myocardial Infarction (MI)||0 to 208 Days|||percentage of participants|||Number
4713|NCT02246166|Primary|Symptom Severity Assessment at 4 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use."|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4714|NCT02246166|Primary|Symptom Severity Assessment at 3 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use."|3 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4715|NCT02246166|Primary|Symptom Severity Assessment at 2 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use."|2 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4716|NCT02246166|Primary|Symptom Severity Assessment at 1 Hour|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use."|1 hour|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4717|NCT02246166|Primary|Symptom Severity Assessment at 30 Minutes|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use."|30 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4718|NCT02246166|Primary|Symptom Severity Assessment at 15 Minutes|"Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use."|15 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
4719|NCT02246114|Primary|Primary Outcome of Serum Cotinine Levels|The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.|1 year|Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.|||||
4720|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before induction of anesthesia|||units on a scale m-YPAS||Standard Deviation|Mean
4721|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before entering operation room|||units on a scale m-YPAS||Standard Deviation|Mean
4975|NCT02229864|Secondary|All Death||0 to 208 Days|||percentage of participants|||Number
4722|NCT02246062|Primary|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (< 30).|24 hours before surgery|||units on a scale m-YPAS||Standard Deviation|Mean
4723|NCT02245360|Secondary|Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment|measurement of IgE in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.||UA/ml||Standard Deviation|Mean
4724|NCT02245360|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum|measurement of IgG4 in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.||mgA/L||Standard Deviation|Mean
4725|NCT02244840|Secondary|Convenience|Questionnaires|3 minute||||||
4726|NCT02244840|Primary|Anal Resting Pressure Change|before and after bidet/sitz bath for 3 minute|3 minute|||mmHg||Standard Deviation|Mean
4727|NCT02244580|Secondary|Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS|Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS|5 years|||Hazard ratio||95% Confidence Interval|Number
4728|NCT02244580|Secondary|Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)|High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)|5 years|||Hazard ratio||95% Confidence Interval|Number
4729|NCT02244580|Primary|5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™|Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))|5 year from the date of patient randomisation|||percentage of analyzed participants|||Number
4730|NCT02243943|Secondary|Sedation|using the Leiden observer alertness score (1 alert - 5 sedated)|45 minutes post surgery|||sedation scale (1 alert - 5 sedated)||95% Confidence Interval|Mean
4731|NCT02243943|Secondary|Pain|using the 1-10 numeric rating scale|45 minutes post surgery|||Numeric rating scale. 1(low)-10(maximum)||95% Confidence Interval|Mean
4732|NCT02243943|Primary|Mean Lowest Saturation|Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery|45 minutes post surgery|||percentage of oxygen saturation||95% Confidence Interval|Mean
4733|NCT02243202|Other Pre-specified|Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26|Percentage of participants with weight loss >= 10 percent at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.||Percentage of Participants|||Number
4734|NCT02243202|Other Pre-specified|Change From Baseline in Pulse Rate at Week 26|Change from baseline in pulse rate at week 26|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Beats Per Minute (Beats/Min)||Standard Error|Least Squares Mean
4735|NCT02243202|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Change from baseline in diastolic blood pressure (DBP) at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
4736|NCT02243202|Secondary|Absolute Change From Baseline in Body Weight at Week 26|Absolute change from baseline in body weight was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Kilogram (Kg)||Standard Error|Least Squares Mean
4737|NCT02243202|Secondary|Change From Baseline in Systolic Blood Pressure at Week 26|Change from baseline in systolic blood pressure was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
4738|NCT02243202|Secondary|Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26|Percentage of participants with weight loss >= 5 percent were analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||percentage of participants|||Number
4739|NCT02243202|Primary|Percent Change From Baseline in Body Weight at Week 26|The percent change from baseline in body weight at Week 26 was analysed.|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Percent Change||Standard Error|Least Squares Mean
4740|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months (from Baseline)|||units on a scale||Standard Deviation|Mean
4741|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months (from Baseline)|||units on a scale||Standard Deviation|Mean
4742|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
4743|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months (from Baseline)|||units on a scale||Standard Deviation|Mean
4744|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months (from Baseline)|||units on a scale||Standard Deviation|Mean
4745|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
4746|NCT02242994|Secondary|Error Rate of Communication|Amount of typing errors per sentence|At time of experiment|||errors||Standard Deviation|Mean
4747|NCT02242994|Primary|Speed of Communication|Measure time (in minutes) to type 3 pre-set sentences|Immediately|||minutes||Standard Error|Mean
4748|NCT02242643|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
4749|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
4750|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
4751|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
4752|NCT02242643|Secondary|Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.|"Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature < 38.0°C but with missing values for at least one day during the solicited period.~Grade 3 fever was defined as temperature greater than (>) 39.0°C."|During a 2-day (Days 0-1) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
4753|NCT02242643|Secondary|Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) follow-up period after each vaccination.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Days||Full Range|Median
4785|NCT02239692|Secondary|Ascending Colon Cleansing Responder Status (ITT)|Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.||percentage of subjects|||Number
4976|NCT02229864|Secondary|All Revascularization||0 to 37 Days|||percentage of participants|||Number
4977|NCT02229864|Secondary|All Target Vessel Revascularization (TVR)||0 to 37 Days|||percentage of participants|||Number
4754|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
4755|NCT02242643|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting ‘Yes’ for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day (Day 0 – Day 6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.||Subjects|||Number
4756|NCT02242643|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
4757|NCT02242643|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
4758|NCT02242643|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
4759|NCT02242643|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Mean
4760|NCT02242643|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
4808|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage|Percentage of participants by convenience of syringe usage was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
4761|NCT02242643|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains|"Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria)."|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
4762|NCT02242630|Other Pre-specified|Safety|Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.|6 weeks||||||
4763|NCT02242630|Secondary|Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale|Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.|6 weeks|||units on a scale||95% Confidence Interval|Mean
4764|NCT02242630|Primary|Change in Shoulder Function, as Measured by the QuickDASH ®|The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)|6 weeks|||units on a scale||95% Confidence Interval|Mean
4765|NCT02242019|Primary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 36 Weeks|Some subjects had multiple toenails with onychomycosis disease involvement that were treated and analyzed, resulting in a total of 139 study toenails being analyzed.||millimeters (mm)|Participants|Standard Deviation|Mean
4766|NCT02242019|Secondary|Change in Percent (%) of Onychomycosis Disease Involvement|The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.|Baseline and 36 Weeks|||percentage of disease involvement|Participants|Standard Deviation|Mean
4767|NCT02242019|Primary|Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|Baseline and 36 Weeks|||toenails|Participants||Number
4768|NCT02240628|Secondary|Pain Intensity|"A blinded independent observer will rate pain on Propofol injection according to a pain scale.~No pain.~Mild pain(associated with facial expression of pain).~Moderate Pain(Pulling/withdrawal of arm).~Severe Pain(Screaming)."|During Propofol injection.|||participants|||Number
4769|NCT02240628|Primary|Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.||During propofol injection.|||participants|||Number
4770|NCT02240368|Secondary|Entropy Awaking|In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia|||units on a scale||Inter-Quartile Range|Median
4771|NCT02240368|Secondary|BISPECTRAL Index Awaking|In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia|||units on a scale||Inter-Quartile Range|Median
4772|NCT02240368|Primary|Entropy|"The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.~Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours|||units on a scale||95% Confidence Interval|Number
4807|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage by ESA Type|Percentage of participants by convenience of syringe usage by ESA type was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4978|NCT02229864|Secondary|All Target Lesion Revascularization (TLR)||0 to 37 Days|||percentage of participants|||Number
4773|NCT02240368|Primary|BISPECTRAL Index|"The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.~Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours|||units on a scale||95% Confidence Interval|Number
4774|NCT02240329|Primary|Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution|The total cough count (CTot) was determined by counting all cough events that occurred following each presentation of capsaicin solution. CTot was made, in real time, by two investigators and confirmed via review of the recorded cough airflow signal. Capsaicin concentration necessary to elicit a two cough threshold response (C2) within 30 seconds of presentation, on at least two (out of three) trials of that concentration, was identified from the cough count record. An average across all measurements was performed for the analysis.|Day 1|||cough events following stimulation||Standard Deviation|Mean
4775|NCT02240329|Primary|Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration|Following 30 seconds of tidal breathing (to allow for acclimation to the facemask), participants were instructed to “take a sharp breath in” whereupon the nebulized capsaicin solution was automatically administered by the dosimeter. Following each aerosol presentation, the participant was instructed to rate their UTC using a modified Borg Rating Scale where 1 = no UTC and 10 = maximum UTC. Between presentations, participants were given a minimum of a one-minute rest period where they were offered water. An average across all measurements was performed for the analysis.|Day 1|||Units on a Borg scale||Standard Error|Mean
4776|NCT02239926|Secondary|Mean Abdominal Pain|Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.|||||
4777|NCT02239926|Primary|Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).|BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.|||||
4778|NCT02239744|Secondary|Fractional Exhaled Nitric Oxide|FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.|within 1 hour after the two-day intervention|||ppb||Standard Deviation|Geometric Mean
4779|NCT02239744|Primary|Lung Function|A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers’ recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.|Within 1 hour after the end of the two-day intervention|Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time.||L||Standard Deviation|Geometric Mean
4780|NCT02239744|Secondary|Blood Pressure|After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.|Within one hour after the 2-day intervention|||mmHg||Standard Deviation|Geometric Mean
4781|NCT02239744|Primary|Circulating Biomarkers|Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.|Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days|||ng/ml||Standard Deviation|Geometric Mean
4782|NCT02239692|Secondary|Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)|Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.||subjects|||Number
4783|NCT02239692|Secondary|Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)|Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.||subjects|||Number
4784|NCT02239692|Secondary|Frequency and Intensity of Adverse Events||From baseline (screening) up to day 10 after colonoscopy|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.||subjects|||Number
4786|NCT02239692|Primary|Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.||score on a scale||Standard Deviation|Mean
4787|NCT02239692|Primary|Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.||score on a scale||Standard Deviation|Mean
4788|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 4|||Degrees||Standard Deviation|Mean
4789|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 3|||Degrees||Standard Deviation|Mean
4790|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 2|||Degrees||Standard Deviation|Mean
4791|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4|||Units on a scale||Full Range|Mean
4792|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3|||Units on a scale||Full Range|Mean
4793|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4|||Units on a scale||Full Range|Mean
4794|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2|||Units on a scale||Full Range|Mean
4795|NCT02239289|Secondary|Fear of Movement Level|Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.|Week 4|||units on a scale||Full Range|Mean
4796|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3|||Units on a scale||Full Range|Mean
4797|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2|||Units on a scale||Full Range|Mean
4798|NCT02239289|Secondary|Disability Level|Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.|Week 4|||units on a scale||Full Range|Mean
4799|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 1|||Degrees||Standard Deviation|Mean
4800|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 4|||ratio||Standard Deviation|Mean
4801|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 3|||ratio||Standard Deviation|Mean
4802|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 2|||ratio||Standard Deviation|Mean
4803|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 1|||Ratio||Standard Deviation|Mean
4804|NCT02238782|Primary|Absolute Bioavailability|To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100|0 to 72 hours post-dose|||% of bioavailability||90% Confidence Interval|Geometric Mean
4805|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain by ESA Type|Percentage of participants by injection site pain by ESA type was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4806|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain|Percentage of participants by injection site pain was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
4831|NCT02238028|Primary|Blood Pressure|The blood pressure were measured by automatic blood pressure monitor during the intervention study.|up to 24 hours|||mmHg||Standard Deviation|Mean
4979|NCT02229864|Secondary|All Myocardial Infarction (MI)||0 to 37 Days|||percentage of participants|||Number
4980|NCT02229864|Secondary|All Death||0 to 37 Days|||percentage of participants|||Number
4809|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types|Percentage of participants by limitation of daily life due to ESA refrigeration requirements by ESA types was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4810|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements|Percentage of participants by limitation of daily life due to ESA refrigeration requirements was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
4811|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency|"Percentage of participants by preferred treatment frequency by baseline ESA frequency was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked for their preference of treatment frequency and baseline ESA frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Percentage of participants by preferred treatment frequency (once a month [O/M], twice a month [B/M], once a week [O/W], twice a week [B/W], three times a week [T/W] or other [any other frequency]) and by frequency of baseline ESA use (three times a week, twice a week, once a week, every 2 weeks [Q2W], every 4 weeks [Q4W] or other [any other frequency]) was reported."|Baseline, Month 6|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4812|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by ESA Type|"Percentage of participants by Preferred treatment frequency by ESA type was Assessed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and their preference of treatment frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency)."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4813|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency|"Percentage of participants by preferred treatment frequency was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency)."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
4814|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type|Percentage of participants by need for improvement in treatment frequency by ESA type was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their need for improvement in the frequency of each treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'improvement is very necessary'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4815|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency|Percentage of participants by need for improvement in treatment frequency was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their need for improvement in the frequency of treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'Improvement is very necessary'.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
4816|NCT02238067|Secondary|Percentage of Participants With Interest in Learning to Inject Independently|Percentage of participants with interest in learning to inject independently was assessed by physician via a satisfaction survey on anemia treatment. Participants responded 'yes' or 'no' to the question: 'Would you be interested in learning to inject independently?' ’ Percentage of participants who responded ‘yes’, was reported.|Baseline, Month 6|All enrolled participants who did not inject independently. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants||95% Confidence Interval|Number
4817|NCT02238067|Secondary|Percentage of Participants by Different Injection Administration Modes|Percentage of participants according to different injection administration modes was assessed by physician via a satisfaction survey on anemia treatment. Participants were asked: 'How do you currently inject the anemia treatment?' and reported any of the 5 possible answers: Independently, by a family member, nurse at home, nurse at the clinic or other.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
4818|NCT02238067|Secondary|Percentage of Participants by Different CKD Stages|Percentage of participants according to different CKD stages was assessed by physician via a satisfaction survey on anemia treatment. CKD stages were based on participant’s answer to the survey question. No specific method of assessment for CKD stage was specified.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
4981|NCT02229864|Secondary|All Revascularization||≤ 7 days post index procedure (In-hospital )|||percentage of participants|||Number
4982|NCT02229864|Secondary|All Target Vessel Revascularization (TVR)||≤ 7 days post index procedure (In-hospital )|||percentage of participants|||Number
4819|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Month 6|Percentage of participants according to frequency and different types of ESA use was assessed by physician via a satisfaction survey on anemia treatment. Percentage of participants by frequency of ESA use (three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other [any other frequency]) and by different ESA types (Mircera, Recormon, Eprex or Aranesp) was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6. Here 'n' signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4820|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Baseline|Percentage of participants according to frequency and different types of ESA use was assessed by physician via a satisfaction survey on anemia treatment. Percentage of participants by frequency of ESA use (three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other [any other frequency]) and by different ESA types (Mircera, Recormon, Eprex or Aranesp) was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here ‘n’ signifies number of participants evaluable for specified categories.||percentage of participants|||Number
4821|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Month 6|Percentage of participants according to frequency of ESA use was assessed by physician via a satisfaction survey on anemia treatment. Percentage of participants by frequency of ESA use (three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other [any other frequency]) was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6||percentage of participants||95% Confidence Interval|Number
4822|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Baseline|Percentage of participants according to frequency of ESA use was assessed by physician via a satisfaction survey on anemia treatment. Percentage of participants by frequency of ESA use (three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other [any other frequency]) was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
4823|NCT02238067|Primary|Percentage of Participants by ESA Types at Month 6|Percentage of participants according to usage of different ESA types was assessed by physician via a satisfaction survey on anemia treatment. Percentage of participants by different ESA types (Mircera, Recormon, Eprex or Aranesp) was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6||percentage of participants||95% Confidence Interval|Number
4824|NCT02238067|Primary|Percentage of Participants by ESA Types at Baseline|Percentage of participants according to usage of different ESA types was assessed by physician via a satisfaction survey on anemia treatment. Percentage of participants by different ESA types (Mircera, Recormon, Eprex or Aranesp) was reported.|Baseline|All enrolled participants||percentage of participants||95% Confidence Interval|Number
4825|NCT02238028|Primary|Circulating Biomarkers——ET-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.|Up to 24 hours|||pg/ml||Standard Deviation|Geometric Mean
4826|NCT02238028|Primary|Circulating Biomarkers——P- Selectin,VCAM-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours|||ng/ml||Standard Deviation|Geometric Mean
4827|NCT02238028|Primary|Circulating Biomarkers——Fibrinogen，vWF|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours|||µg/ml||Standard Deviation|Geometric Mean
4828|NCT02238028|Primary|Heart Rate Variability—pNN50|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.|Up to 24 hours|||percentage of ms||Standard Deviation|Geometric Mean
4829|NCT02238028|Primary|Heart Rate Variability—LF/HF|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|Up to 24 hours|||ratio||Standard Deviation|Geometric Mean
4830|NCT02238028|Primary|Heart Rate Variability-SDNN,SDANN, rMSSD|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.|Up to 24 hours|||ms||Standard Deviation|Geometric Mean
4832|NCT02238028|Primary|Heart Rate Variability-LF Power,HF Power,VLF Power|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|up to 24 hours|||ms^2||Standard Deviation|Geometric Mean
4833|NCT02237092|Secondary|Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg||After spinal anesthesia, average 20 minutes.|||Number of pregnants with Blocks = > Th4|||Number
4834|NCT02237092|Secondary|The Level of IAP|The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks|After spinal anesthesia, average 20 minutes.|||mm Hg||Standard Error|Median
4835|NCT02237092|Primary|Obesity and IAP|Effect of obesity on the level of IAP|Before spinal anesthesia, average 10 minutes.|||mm Hg||Standard Error|Median
4836|NCT02237092|Secondary|Level of Sensory Blocks|Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra|After spinal anesthesia, average 20 minutes.|||Block level level of thoracic vertebrae||Standard Error|Median
4837|NCT02237092|Primary|Classification Grade of Intra-abdominal Hypertension (IAH)|Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)|Before spinal anesthesia, average 10 minutes.|||mm Hg||Standard Error|Median
4838|NCT02237092|Primary|The Level of Intra-abdominal Pressure (IAP)|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.|Before spinal anesthesia, average 10 minutes.|||mm Hg||Standard Error|Median
4839|NCT02236767|Primary|The Saving Inventory-Revised (SI-R) Total Score|The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.|Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up|||units on a scale|||Number
4840|NCT02236611|Primary|Change From Baseline in Trough FEV1 on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis||Liter||Standard Error|Least Squares Mean
4841|NCT02236130|Secondary|Patient/Family Satisfaction With Pain Management|Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.|one week after the surgery|||Participants|||Count of Participants
4842|NCT02236130|Primary|Total Hydrocodone Dose (mg/kg)||day 2 and day 8 after the surgery|||mg/kg||Standard Deviation|Mean
4843|NCT02235831|Primary|Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.|Day 5, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).||diopter*logMar|||Number
4844|NCT02235493|Secondary|Performance-Oriented Mobility Assessment-Gait Subtest (POMA-G) - Change From Baseline to Last Overall|The POMA-G is a 7-component assessment that is used to evaluate gait performance. The second component has 4 sub-components. Scores of 0, 1 or 2 are assigned to 2 components while scores of 0 or 1 are assigned to the rest of the 4 components and 4 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients’ aged 5 to 15 years, inclusive.|||units on a scale||Inter-Quartile Range|Median
4864|NCT02233647|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4845|NCT02235493|Primary|Modified Performance-Oriented Mobility Assessment-Gait Subtest (MPOMA-G) - Change From Baseline to Last Overall|The MPOMA-G is a 5-component assessment that is used to evaluate gait performance. The first component has 4 sub-components. For 2 components and 2 sub-components, scores of 0 or 1 are assigned while scores of 0, 1 or 2 are assigned to the rest of the 2 components and 2 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients’ aged 5 to 15 years, inclusive.|||units on a scale||Inter-Quartile Range|Median
4846|NCT02235285|Primary|Post Surgical Complications and Reoperation Rate During Breast Augmentation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.|5 years|||percentage of participants||Standard Deviation|Mean
4847|NCT02234479|Primary|Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy|The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.|12 months|Participants were analyzed for skin changes (during weekly visits with physician) during radiation treatment. Only 15 participants from each group completed the study, 1 subject from Group A and 3 subjects from Group B withdrew.||participants|||Number
4848|NCT02234427|Primary|Differential Gene Expression|Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area|2-weeks|The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.||FPKM for HBG1 Gene||Standard Error|Mean
4849|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of PI scores of >= 2||Standard Deviation|Mean
4850|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of PI scores of >= 3||Standard Deviation|Mean
4851|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of MGI scores of >= 3||Standard Deviation|Mean
4852|NCT02233998|Secondary|Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of BI scores of 0||Standard Deviation|Mean
4983|NCT02229864|Secondary|All Target Lesion Revascularization (TLR)||≤ 7 days post index procedure (In-hospital )|||percentage of participants|||Number
4853|NCT02233998|Secondary|Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of PI scores of 0 or 1||Standard Deviation|Mean
4854|NCT02233998|Secondary|Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||percentage of MGI scores of 0 or 1||Standard Deviation|Mean
4855|NCT02233998|Secondary|Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4856|NCT02233998|Primary|Whole Mouth Mean Plaque Index (PI) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4857|NCT02233998|Primary|Whole Mouth Mean Modified Gingival Index (MGI) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
4858|NCT02233842|Primary|Time From Cancer Diagnosis to the Date of the Interview|Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).|up to 24 years|||years||Full Range|Median
4859|NCT02233842|Primary|Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis|Current and former smokers who were smoking at the time of their cancer diagnosis.|Day 1 of interview|||participants|||Number
4860|NCT02233842|Primary|Number of Smokers at the Time of the Interview|Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.|Day 1 of interview|||participants|||Number
4861|NCT02233842|Primary|Number of Participants to Achieve Saturation in an English-language Paper Questionnaire|Saturation is defined as satisfactory measurement of performance without need of further review.|Last subject interviewed, an average of 5 months|||participants|||Number
4862|NCT02233647|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4863|NCT02233647|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4865|NCT02233647|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4866|NCT02233647|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4867|NCT02233647|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4868|NCT02233647|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4869|NCT02233647|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4870|NCT02233647|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4871|NCT02233647|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4872|NCT02233647|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4873|NCT02233647|Secondary|"Peak Ratings of Nauseated/Queasy/Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated/Queasy/Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4874|NCT02233647|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4875|NCT02233647|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4876|NCT02233647|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4984|NCT02229864|Secondary|All Myocardial Infarction (MI)||≤ 7 days post index procedure (In-hospital )|||percentage of participants|||Number
4877|NCT02233647|Secondary|"Peak Ratings of Good Effect on the Visual Analog Scale"|"Subjects rated their feelings of Good Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4878|NCT02233647|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4879|NCT02233647|Secondary|"Peak Ratings of Bad Effect on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4880|NCT02233647|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4881|NCT02233647|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4882|NCT02233647|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 stimulant items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4883|NCT02233647|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
4884|NCT02233647|Primary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||Degrees Fahrenheit||Standard Error|Mean
4885|NCT02233647|Primary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||Beats per Minute||Standard Error|Mean
4886|NCT02233647|Primary|Peak Diastolic Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
4887|NCT02233647|Primary|Peak Systolic Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
4888|NCT02233309|Primary|Pressure in the Caudal Epidural Space|After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.|Immediately post bolus|Due to errors in data collection or protocol violations, 5 patients were excluded leaving 31 patients for analysis.||mmHg||Standard Deviation|Mean
4901|NCT02231918|Secondary|Vital Signs (Pulse Rate)|Vital signs (Pulse rate (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h|Safety analysis set||bpm||Standard Deviation|Mean
4902|NCT02231918|Secondary|Vital Signs (Systolic and Diastolic Blood Pressure)|Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.||mmHg||Standard Deviation|Mean
4889|NCT02233296|Primary|Pharmacokinetics - AUC0-inf (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"||ng.h/mL||Standard Deviation|Mean
4890|NCT02233296|Primary|Pharmacokinetics - AUC0-t (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"||ng.h/mL||Standard Deviation|Mean
4891|NCT02233296|Secondary|Tolerability|Tolerability was defined as the number of subjects that did not withdraw from the study early due to adverse events.|15 days|All the subjects included in the study who received at least one dose of lasmiditan (n=30). Subject disposition was considered for all subjects under the fed condition and then all subjects under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).||participants|||Number
4892|NCT02233296|Secondary|Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).|Safety was evaluated in all subjects (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.|Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days|All the subjects included in the study who received at least one dose of lasmiditan (n=30). Adverse events were considered in all subjects under the fed condition and then in all subjects under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).||participants with adverse events|||Number
4893|NCT02233296|Primary|Pharmacokinetics - Tmax (Hours)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"||hours||Standard Deviation|Mean
4894|NCT02233296|Primary|Pharmacokinetics - Cmax (ng/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all subjects with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"||ng/mL||Standard Deviation|Mean
4895|NCT02232880|Secondary|Change in Inflammatory Markers|changes in plasma and T cell markers of activation and T cell cytokine production from randomization to end of 24 weeks of treatment|6 months|No patients received treatment prior to study termination|||||
4896|NCT02232880|Secondary|Change in Brachial Artery Reactivity|change in brachial artery reactivity measured at randomization and after 24 weeks of treatment|6 months|No patients received treatment prior to study termination|||||
4897|NCT02232880|Secondary|Change in Blood Pressure|Changes in the rate of change of blood pressure estimated by automated in office cuff measurements and ambulatory blood pressure at 12 weeks after randomization|6 months|No patients received treatment prior to study termination.|||||
4898|NCT02232880|Primary|Change in Systolic Blood Pressure From Randomization to End of Treatment|Ambulatory blood pressure monitoring will be used at the end of the 4 weeks standardized treatment and at the end of 6 months randomized treatment with abatacept or placebo. The change in systolic blood pressure from these 2 recordings will be the primary endpoint.|6 months|No patients received treatment prior to study termination|||||
4899|NCT02232126|Secondary|30-day Readmission Among Intervention Participants|The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.|30-days|Analysis among Intervention group ONLY for this outcome||30-day hospital readmissions|||Number
4900|NCT02232126|Primary|30-day Hospital Readmission|The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.|30-days post hospitalization|||30-day hospital readmissions|||Number
4904|NCT02231918|Primary|PTF|Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||% of PTF||Geometric Coefficient of Variation|Geometric Mean
4905|NCT02231918|Primary|CLR,ss|Renal clearance of the analyte at steady state (CLR(0-12),ss ).|12h after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||mL/min||Geometric Coefficient of Variation|Geometric Mean
4906|NCT02231918|Primary|fe 0-12,ss|Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).|12 hours after last study drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||% of PPX excreted||Geometric Coefficient of Variation|Geometric Mean
4907|NCT02231918|Primary|Ae 0-12,ss|Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).|12 hours after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng||Geometric Coefficient of Variation|Geometric Mean
4908|NCT02231918|Primary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||L||Geometric Coefficient of Variation|Geometric Mean
4909|NCT02231918|Primary|CL/F,ss|Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||mL/min||Geometric Coefficient of Variation|Geometric Mean
4910|NCT02231918|Primary|MRTpo,ss|Mean residence time of the analyte in the body at steady state (MRTpo,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||h||Geometric Coefficient of Variation|Geometric Mean
4911|NCT02231918|Primary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||hours||Geometric Coefficient of Variation|Geometric Mean
4912|NCT02231918|Primary|λz,ss|Terminal rate constant in plasma at steady state (λz,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||1/h||Geometric Coefficient of Variation|Geometric Mean
4913|NCT02231918|Primary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).|0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
4914|NCT02231918|Primary|Tmin,ss|Time from dosing to minimum concentration at steady state (Tmin,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||hours||Full Range|Median
4915|NCT02231918|Primary|Tmax,ss|Time from dosing to maximum concentration at steady state (Tmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||hours||Full Range|Median
4916|NCT02231918|Primary|Cavg|Average concentration of the analyte in plasma at steady state (Cavg).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
4917|NCT02231918|Primary|Cpre,N|Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
4918|NCT02231918|Primary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Standard Deviation|Geometric Mean
4919|NCT02231918|Primary|Cmax,ss|Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
4920|NCT02231177|Secondary|Clinical Relevant Abnormalities in Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinically relevant abnormalities in vital signs (blood pressure and pulse rate), physical examination, blood chemistry, haematology, urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Any adverse events which occurred within 14 days following the last drug administration were assigned to the last study treatment administered.|From drug administration until 14 days following the last drug administration|Treated Set. All randomised patients who received at least one dose of trial medication were included in the treated set.||participants|||Number
4921|NCT02231177|Secondary|FEV1 Change From Baseline|"Mean change from baseline in forced expiratory volume in one second (FEV1). Pulmonary function test.~The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.||L||Standard Deviation|Mean
4922|NCT02231177|Secondary|FVC Change From Baseline|"Mean change from baseline in forced vital capacity (FVC). Pulmonary function test.~The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.||L||Standard Deviation|Mean
4923|NCT02231177|Secondary|Concentration of Tiotropium in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
4924|NCT02231177|Secondary|Concentration of Olodaterol in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
4925|NCT02231177|Secondary|Tmin,ss of Tiotropium|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
4926|NCT02231177|Secondary|Tmin,ss of Olodaterol|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
4927|NCT02231177|Secondary|Cmin,ss of Tiotropium|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
4928|NCT02231177|Secondary|Cmin,ss of Olodaterol|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
4929|NCT02231177|Secondary|fe(0-24,ss) of Tiotropium|"Fraction of Tiotropium eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||percentage of tiotropium dose||Geometric Coefficient of Variation|Geometric Mean
4930|NCT02231177|Secondary|fe(0-24,ss) of Olodaterol|"Fraction of Olodaterol eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||percentage of olodaterol dose||Geometric Coefficient of Variation|Geometric Mean
4931|NCT02231177|Secondary|Tmax,ss of Tiotropium|Time from dosing to the maximum concentration of Tiotropium in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
4932|NCT02231177|Secondary|Tmax,ss of Olodaterol|Time from dosing to the maximum concentration of Olodaterol in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||h||Full Range|Median
4985|NCT02229864|Secondary|All Death||≤ 7 days post index procedure (In-hospital )|||percentage of participants|||Number
4933|NCT02231177|Secondary|AUC(0-tz,ss) of Tiotropium|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Tiotropium.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
4934|NCT02231177|Secondary|AUC(0-tz,ss) of Olodaterol|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Olodaterol.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
4935|NCT02231177|Secondary|AUC(0-4h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=4 h at steady state (AUC(0-4h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
4936|NCT02231177|Secondary|AUC(0-2h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval 0 to 2 hours at steady state (AUC(0-2h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
4937|NCT02231177|Secondary|Cmax,ss of Tiotropium|"Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
4938|NCT02231177|Secondary|AUC(0-6h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=6 h at steady state (AUC(0-6h,ss)).~As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Tiotropium. Based on the given definition AUC(0-6h,ss) was selected as secondary endpoint.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
4939|NCT02231177|Secondary|Ae(0-24h,ss) of Olodaterol|"Amount of Olodaterol that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||ng||Geometric Coefficient of Variation|Geometric Mean
4940|NCT02231177|Primary|Ae(0-24h,ss) of Tiotropium|"Amount of Tiotropium that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||ng||Geometric Coefficient of Variation|Geometric Mean
4941|NCT02231177|Primary|Cmax,ss of Olodaterol|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
4942|NCT02231177|Primary|AUC(0-1h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval t1=0 to t2=1 hour at steady state (AUC(0-1h,ss)).~As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Olodaterol. Based on the given definition AUC(0-1h,ss) was selected as primary endpoint.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic (PK) set which included all patients in the treated set who provided at least one of the PK parameters in at least one treatment period and completed the trial without any important protocol violations, it is however restricted to patients with evaluable data for this endpoint.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
4943|NCT02231164|Primary|Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1|This outcome measure presents number of patients with disease control according to RECIST, version 1.1.|Up to 6 months.|Randomised Set: The randomised set included all randomised patients.||Percentage of participants|||Number
8497|NCT02092649|Primary|Change in Resting Metabolic Rate From Baseline|Percent change in resting metabolic rate|Baseline, 6 weeks, 12 weeks|||percent change||Standard Deviation|Mean
4944|NCT02230904|Secondary|Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||units on a scale||Standard Deviation|Mean
4945|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2|"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
4946|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1|"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
4947|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
4948|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
4949|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group “less than or equal to 70 % adhered or patch detachment” which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
4986|NCT02229864|Secondary|Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 393 Days|||percentage of participants|||Number
4987|NCT02229864|Secondary|Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 208 Days|||percentage of participants|||Number
4950|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group “less than or equal to 70 % adhered or patch detachment” which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||percentage of patches|Participants||Number
4951|NCT02230904|Primary|Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = > 95 - 100 % of the patch area adheres~1 = > 90 - 95 % of the patch adheres~2 = > 85 - 90 % of the patch adheres~3 = > 80 - 85 % of the patch adheres~4 = > 75 - 80 % of the patch adheres~5 = > 70 - 75 % of the patch adheres~6 = ≥ 50 - 70 % of the patch adheres~7 = < 50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline.~The average of patches 1 and 2 is presented by Treatment Arm below."|Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.||units on a scale||Standard Deviation|Mean
4952|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 2 (PSS2)|Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21.|11 weeks|intention-to-treat||units on a scale||Standard Deviation|Mean
4953|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 1 (PSS1)|Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60.|0-11 weeks|intention-to-treat||units on a scale||Standard Deviation|Mean
4954|NCT02230761|Primary|Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported|Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.|11 weeks|intention-to-treat||participants|||Number
4955|NCT02230683|Secondary|Concentration of Caspase 3/7 RLU|Median change of concentration of Caspase 3/7 Relative Light Units from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT|||RLU||Full Range|Median
4956|NCT02230683|Secondary|Change in Aspartate Aminotransferase (AST)|Median change of AST from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT|||U/L||Full Range|Median
4957|NCT02230683|Secondary|Change in Alanine Aminotransferase (ALT)|Median change of ALT from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT|||U/L||Full Range|Median
4958|NCT02230683|Primary|Change in cCK18/M30|Median change of caspase-cleaved cytokeratin serum levels (cCK18/M30) from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)|||U/L||Full Range|Median
4959|NCT02230683|Primary|cCK18/M30|Absolute Mean Change of caspase-cleaved cytokeratin serum levels (cCK18/M30); the statistical analysis is based on the mean change in log-transformed cCK18/M30 from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Change from Baseline to Day 28/EOT|||U/L||Standard Deviation|Mean
4960|NCT02230683|Primary|Hepatic Venous Pressure Gradient (HVPG)|Mean change of HVPG [mmHg] from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)|23 subjects were enrolled, of whom 22 were evaluable for the HVPG endpoint. 1 subject discontinued at day 1.||mmHg||Standard Deviation|Mean
4961|NCT02230540|Primary|Residual Volume Less Than 100ml|"The primary endpoint was “Residual volume less than 100 ml (Yes/No)” assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.~Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.~Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from “300ml – collected volume <100ml” to “collected volume > 200ml”, were used to interpret the primary endpoint."|2-4 hours|||Subjects with successful catheterization|||Number
4962|NCT02230085|Primary|CPAP Therapy Adherence||90 days|||participants|||Number
4963|NCT02229864|Secondary|Late Stent/Scaffold Thrombosis (Definite/Probable)||31 to 393 days|||percentage of participants|||Number
4964|NCT02229864|Secondary|Subacute Stent/Scaffold Thrombosis (Definite/Probable)||>1 to 30 days|||percentage of participants|||Number
4965|NCT02229864|Secondary|Acute Stent/Scaffold Thrombosis (Definite/Probable)||≤ 1 day|||percentage of participants|||Number
4966|NCT02229864|Secondary|All Revascularization||0 to 393 Days|||percentage of participants|||Number
4967|NCT02229864|Secondary|All Target Vessel Revascularization (TVR)||0 to 393 Days|||percentage of participants|||Number
4968|NCT02229864|Secondary|All Target Lesion Revascularization (TLR)||0 to 393 Days|||percentage of participants|||Number
4969|NCT02229864|Secondary|All Myocardial Infarction (MI)||0 to 393 Days|||percentage of participants|||Number
4970|NCT02229864|Secondary|All Death||0 to 393 Days|||percentage of participants|||Number
4971|NCT02229864|Secondary|All Revascularization||0 to 208 Days|||percentage of participants|||Number
4989|NCT02229864|Secondary|Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|≤ 7 days post index procedure (In-hospital )|||percentage of participants|||Number
4990|NCT02229864|Primary|Drug Clearance (CL)|"The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~Calculated as: CL = Dose/AUC0 - ∞ ."|0 to 30 days|||Liter/hour||Full Range|Median
4991|NCT02229864|Primary|Terminal Elimination Half-life (t1/2term)|"The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~calculated as: t1/2term = 0.693/λz."|0 to 30 days|||Hours||Full Range|Median
4992|NCT02229864|Primary|Terminal Elimination Rate Constant (λz)|The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.|0 to 30 days|||1/hour||Full Range|Median
4993|NCT02229864|Primary|AUC 0-infinity|"AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~calculated as: AUC0-∞ = AUClast + (Clast/λz)~The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:~%AUC0-∞ex = (AUC0-∞ – AUClast)/ AUC0-∞ * 100"|0 to 30 days|||ng*h/mL||Full Range|Median
4994|NCT02229864|Primary|AUClast|Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.|0 to 30 days|||ng*h/mL||Full Range|Median
4995|NCT02229864|Primary|AUC24h|Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.|0 to 30 days|||ng*h/mL||Full Range|Median
4996|NCT02229864|Primary|Time of Maximum (Tmax)|Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days|||Hours||Full Range|Median
4997|NCT02229864|Primary|Maximum Concentration (Cmax)|Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days|||nanograms per milliliter||Full Range|Median
4998|NCT02229513|Secondary|Requirement of Cesarean Hysterectomy||During surgery and in the PACU (approximately 3 total hours)|||participants|||Number
4999|NCT02229513|Secondary|Total Blood Loss Greater Than 1000 cc||Intra-op, Post-Op|||participants|||Number
5000|NCT02229513|Secondary|Requirement of Blood Products||During surgery and in the PACU (approximately 3 total hours)|||participants|||Number
5001|NCT02229513|Secondary|Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions||Intraoperatively|||participants|||Number
5002|NCT02229513|Secondary|Bakri Bulb Placement||Intraoperatively|||participants|||Number
5003|NCT02229513|Secondary|Use of Cytotec||Intraoperatively|||participants|||Number
5004|NCT02229513|Secondary|Use of Hemabate||Intraoperatively|||participants|||Number
5005|NCT02229513|Secondary|Use of Methergine||Intraoperatively|||participants|||Number
5006|NCT02229513|Other Pre-specified|Uterine Temperature After Wrap Removed||Immediately following hysterotomy repair|||degrees Fahrenheit||Standard Deviation|Mean
5007|NCT02229513|Other Pre-specified|Total Time Uterus Wrapped||During hysterotomy repair|||minutes||Standard Deviation|Mean
5008|NCT02229513|Other Pre-specified|Patient Temperature||Pre-op, Intra-op, Post-Op|||degrees Fahrenheit||Standard Deviation|Mean
5009|NCT02229513|Secondary|Use of Extra Oxytocin||Intraoperatively|||participants|||Number
5010|NCT02229513|Secondary|Use of Uterotonic Medications||During surgery and in the PACU (approximately 3 total hours)|||participants|||Number
5011|NCT02229513|Secondary|Change in Pre- vs Post-operative Hematocrit||48 hours post operative period|||percent||Standard Deviation|Mean
5012|NCT02229513|Primary|Blood Loss|At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.|During surgery and in the PACU (approximately 3 total hours)|||cc||Standard Deviation|Mean
5013|NCT02229461|Secondary|Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 1 at time point Day 7/1 Hour, Day 7/3 Hour, Day 7/6 Hour, Day 7/12 Hour was 12.||percentage||95% Confidence Interval|Mean
5065|NCT02226198|Secondary|Physical Exam Abnormalitites|Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.|Screening, Week 0, week 6, week 12 and week 18, week 24|||participants|||Number
5066|NCT02226198|Secondary|ECG Abnormalities|Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)|Week 0|||participants|||Number
5014|NCT02229461|Secondary|Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 4 at time point Day 7/1 Hour was 12; 11 in group 6, 7 in Group 5, 12 in Group 6 at Day 16/1 Hour.||percentage||95% Confidence Interval|Mean
5015|NCT02229461|Secondary|Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)|Percentages are based on the number of participants in the Evaluable Population in each treatment group.||percentage||95% Confidence Interval|Mean
5016|NCT02229461|Primary|Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.|At hour 24 on Day 16 post treatment|Percentages are based on the number of participants in the Evaluable Population in each treatment group.||percentage||95% Confidence Interval|Mean
5017|NCT02229318|Secondary|Ease of Preparation of FruitiVits|"Ease of preparation of FruitiVits was rated on a scale of 1-5:~(very easy)~(moderately easy)~(neither easy nor difficult)~(moderately difficult)~(very difficult).~Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients"|Day 8 of trial|Children aged 4 to 8 years.||participants|||Number
5018|NCT02229318|Primary|Acceptability of FruitiVits|"The study product was rated on a scale of 1-5:~(liked very much)~(liked moderately)~(neither liked nor disliked)~(disliked moderately)~(disliked very much)."|Day 8 of trial|Children aged 4 to 8 years.||participants|||Number
5019|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|||percent of participants|||Number
5020|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment||Baseline, end of treatment|||percent of participants|||Number
5021|NCT02229214|Secondary|Change in Cystatin C From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment cystatin C measurements.||mg/L||Standard Error|Mean
5022|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR"|Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after treatment iGFR measurements.||mL/min/1.73 m^2||Standard Error|Mean
5023|NCT02229214|Secondary|Change in Cystatin C From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment cystatin C measurements.||mg/L||Standard Error|Mean
5024|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment serum creatinine measurements.||mg/dL||Standard Error|Mean
5025|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment serum creatininine measurements||mg/dL||Standard Error|Mean
5026|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR."|Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment iGFR measurements.||mL/min/1.73 m^2||Standard Error|Mean
5027|NCT02228980|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine|"Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).~Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever >39.5˚C; Crying abnormal - >3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)"|Day 0 up to Day 7 post any vaccination|Solicited injection site and systemic reactions were assessed in the Safety Population.||Participants|||Number
5067|NCT02226198|Secondary|Urinalysis Abnormalitites|Safety and tolerability will be described in terms of abnormal urine laboratory values|Week 0, week 6, week 12 and week 18|||participants|||Number
5068|NCT02226198|Secondary|ApoB/ApoA|Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
5069|NCT02226198|Secondary|Non-HDL C/HDL C|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
5028|NCT02228980|Other Pre-specified|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
5029|NCT02228980|Other Pre-specified|Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
5030|NCT02228980|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
5031|NCT02228395|Secondary|Dose Normalized AUCinf (AUCinf[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
5032|NCT02228395|Secondary|Dose Normalized AUClast (AUClast[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
5033|NCT02228395|Secondary|Dose Normalized Cmax (Cmax[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||mg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
5034|NCT02228395|Secondary|Terminal Elimination Half-Life (t1/2)|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hours||Standard Deviation|Mean
5035|NCT02228395|Secondary|Apparent Volume of Distribution (Vz/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||liters||Geometric Coefficient of Variation|Geometric Mean
5036|NCT02228395|Secondary|Apparent Clearance (CL/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
5037|NCT02228395|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5038|NCT02228395|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
5039|NCT02228395|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hours||Full Range|Median
5040|NCT02228395|Secondary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
5041|NCT02228395|Primary|Number of Participants With Abnormal Neurological Examination Findings|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA)|Baseline up to Day 10|||participants|||Number
5042|NCT02228395|Primary|Number of Participants With Abnormal Physical Examination Findings|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 10|||participants|||Number
8498|NCT02092610|Secondary|Implant Survival||60 months|"These data are already presented in the Longterm Survival of Implant section."|||||
5043|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.||participants|||Number
5044|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.||participants|||Number
5045|NCT02228395|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.||participants|||Number
5046|NCT02228395|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration.|The safety analysis population included all participants who received the study medication.||participants|||Number
5047|NCT02228395|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.||participants|||Number
5048|NCT02227485|Primary|Modified Gingival Index|"0= Absence of inflammation~Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary~Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary~moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary~severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||units on a scale||Standard Deviation|Mean
5049|NCT02227485|Primary|Pocket Depth|It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||mm||Standard Deviation|Mean
5050|NCT02227485|Secondary|Satisfaction of Patients|"We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.~This VAS ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:~Not satisfied at all~Not satisfied adequately~Not good-Not bad (So So)~Mostly Satisfied~Fully satisfied"|Up to 2 week|||participants|||Number
5051|NCT02227485|Secondary|Number of Participants With Adverse Events||Up to 2 weeks|||participants|||Number
5052|NCT02227485|Primary|Bleeding Index|"presence of bleeding of the gum when probing it: 0= No bleeding~1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||units on a scale||Standard Deviation|Mean
5070|NCT02226198|Secondary|TC/HDL C|Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
5071|NCT02226198|Secondary|LDL C/HDL C|Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||ratio||Standard Deviation|Mean
5053|NCT02227485|Primary|Plaque Index|"0 No plaque~A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.~Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.~Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.||units on a scale||Standard Deviation|Mean
5054|NCT02227121|Primary|Defibrillation Outcome|Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.|Day of procedure|Only subjects with ventricular fibrillation successfully induced were eligible for analysis||Participants|||Count of Participants
5055|NCT02226562|Secondary|Mean Change From Baseline in VRS at Week 4|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Score on scale||Standard Deviation|Mean
5056|NCT02226562|Secondary|Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Score on scale||Standard Deviation|Mean
5057|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Gram (g)||Standard Deviation|Mean
5058|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Gram(g)||Standard Deviation|Mean
5059|NCT02226562|Secondary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Scores on scale||Standard Deviation|Mean
5060|NCT02226562|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.||Score on scale||Standard Error|Least Squares Mean
5061|NCT02226549|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set||percentage of participants|||Number
5062|NCT02226549|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug.||percentage of participants|||Number
5063|NCT02226549|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
5064|NCT02226198|Secondary|Abnormal Vital Signs|Safety and tolerability will be described in terms of abnormal vital signs|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||participants|||Number
5074|NCT02226198|Secondary|Tanner Stage|"Stages for fem (Pubic hair, Breasts):~(Preadol,Preadol)~(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)~(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)~(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)~(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)~1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred."|Week 0 (start of cross-over)|||stage||Standard Deviation|Mean
5075|NCT02226198|Secondary|Weight|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18|||kg||Standard Deviation|Mean
5076|NCT02226198|Secondary|Height Z-score|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18|||ratio||Standard Deviation|Mean
5077|NCT02226198|Secondary|Height|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18|||cm||Standard Deviation|Mean
5078|NCT02226198|Secondary|Abnormal Serum Levels|Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||participants|||Number
5079|NCT02226198|Secondary|AE's Leading to Discontinuation|Safety and tolerability will be described in terms of rate of discontinuations due to adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||adverse events|||Number
5080|NCT02226198|Secondary|Adverse Events|Safety and tolerability will be described in terms of frequency and severity of adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)|||adverse events|||Number
5081|NCT02226198|Secondary|Trough Concentrations|Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.|Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)|||ng/mL||Standard Deviation|Mean
5082|NCT02226198|Secondary|LDL-C From End of Placebo (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)|||mmol/L||Standard Deviation|Mean
5083|NCT02226198|Secondary|LDL-C From End of Placebo (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)|||mg/dL||Standard Deviation|Mean
5084|NCT02226198|Secondary|LDL-C, Not on Apheresis (mmol/L)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis||mmol/L||Standard Deviation|Mean
5085|NCT02226198|Secondary|LDL-C, Not on Apheresis (mg/dL)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis||mg/dL||Standard Deviation|Mean
5086|NCT02226198|Secondary|HDL-C (mmol/L)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
5087|NCT02226198|Secondary|HDL-C (mg/dL)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
5088|NCT02226198|Secondary|ApoB (g/L)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||g/L||Standard Deviation|Mean
5089|NCT02226198|Secondary|ApoB (mg/dL)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
5090|NCT02226198|Secondary|Non-HDL C (mmol/L)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
5091|NCT02226198|Secondary|Non-HDL C (mg/dL)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
5092|NCT02226198|Secondary|TC (mmol/L)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mmol/L||Standard Deviation|Mean
5093|NCT02226198|Secondary|TC (mg/dL)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)|||mg/dL||Standard Deviation|Mean
5094|NCT02226198|Primary|LDL-Cholesterol (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH||mmol/L||Standard Deviation|Mean
5095|NCT02226198|Primary|LDL-Cholesterol (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH||mg/dL||Standard Deviation|Mean
5096|NCT02224820|Secondary|Pharmacokinetics|IdeS T1/2 in alpha phase. One patient who interrupted dose was excluded.|Up to 21 days|||h||Inter-Quartile Range|Mean
5097|NCT02224820|Secondary|Immunogenicity|Presence of Anti-Drug Antibodies formation in serum throughout a 64 day period|Up to 64 days|||participants|||Number
5098|NCT02224820|Secondary|Pharmacodynamics|IgG cleavage and regeneration measured by ELISA|Up to day 64|||µg/mL||Standard Deviation|Mean
5099|NCT02224820|Secondary|Safety|Adverse events (all clinical laboratory tests, vital signs and ECG jugded as clinically significant were reported as AEs)|9 weeks|||Adverse events|||Number
5100|NCT02224820|Primary|Efficacy|Efficacy was defined as the IdeS dosing scheme in the majority of the patients resulting in human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as mean fluorescent intensity (MFI) of less than 1100, within 24 hours from dosing. MFI was determined by single antigen bead (SAB) assay and detection of complement fixating ability (CIq Screen) in serum.|24 hours|||MFI||Inter-Quartile Range|Mean
5101|NCT02224625|Primary|Grading Scale for Visual Evaluation of Skin Condition|"Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.~Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.~Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading"|21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)|Participants received more than one product at a time.||Scores Ranging (0-7)||Full Range|Mean
5102|NCT02224404|Secondary|Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance|This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm|6 weeks|Pain during product removal at week 6, measured by Visual Analog scale.||units on a scale||Inter-Quartile Range|Median
5103|NCT02224404|Primary|Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)|the subjects will be measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and presence of residual from study product on the skin|6 weeks|||participants|||Number
5104|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 AUC|Assessment of the PK of AZ5104 and AZ7550 AUC using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Ratio||Full Range|Geometric Mean
5105|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 Cmax|Assessment of the PK of AZ5104 and AZ7550 Cmax using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Ratio||Full Range|Geometric Mean
5106|NCT02224053|Secondary|AUC of AZ5104 and AZ7550|Area under the plasma concentration-time curve from zero to infinity of AZ5104 and AZ7550 (metabolites to AZD9291)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
5107|NCT02224053|Secondary|Cmax of AZ5104 and AZ7550|Assessment of the PK of AZ5104 and AZ7550 (metabolites to AZD9291) using the maximum plasma concentration, Cmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM||Full Range|Geometric Mean
5108|NCT02224053|Secondary|Vz/F of AZD9291|Assessment of the PK of AZD9291 using the apparent volume of distribution, Vz/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L||Full Range|Geometric Mean
5109|NCT02224053|Secondary|CL/F of AZD9291|Assessment of the PK of AZD9291 using the apparent plasma clearance, CL/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L/h||Full Range|Geometric Mean
5110|NCT02224053|Secondary|λz|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal rate constant, λz|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||1/h||Full Range|Geometric Mean
5111|NCT02224053|Secondary|t(1/2)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal half-life, t(1/2)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||h||Full Range|Geometric Mean
5112|NCT02224053|Secondary|Tlag|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using lag time before observation of quantifiable analyte concentrations in plasma, tlag|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||h||Full Range|Median
5113|NCT02224053|Secondary|Tmax|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using time to reach maximum plasma concentration, tmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||h||Full Range|Median
5114|NCT02224053|Secondary|AUC(0-72)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from time zero to 72 hours, AUC(0-72)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
5115|NCT02224053|Secondary|AUC(0-t)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from zero extrapolated to o the time of the last quantifiable concentration, AUC(0-t)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
5116|NCT02224053|Primary|Cmax of AZD9291|Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma concentration (Cmax).|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM||Full Range|Geometric Mean
5117|NCT02224053|Primary|AUC of AZD9291|Area under the plasma concentration-time curve from zero to infinity for AZD9291|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM.h||Full Range|Geometric Mean
5118|NCT02223871|Post-Hoc|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a New Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated following the data-driven method by Marquart et al. (2015), removing potential lag and tail phases prior to log-linear regression modeling."|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 8 with the method described by Marquart et al., 2015)||Ratio||95% Confidence Interval|Mean
5119|NCT02223871|Secondary|Change From Baseline in Respiratory Rate to End of Study (EOS)||Day 28 (EOS)|||Breaths/min||Full Range|Median
5120|NCT02223871|Secondary|Change From Baseline in Body Temperature up to End of Study (EOS)|Body temperature was measured orally|Day 28 (EOS)|||Degree Celsius||Full Range|Median
5121|NCT02223871|Secondary|Change From Baseline in Blood Pressure to End of Study (EOS)|Vital signs, including diastolic and systolic blood pressure (DBP/SBP), were measured at each outpatient visit up to 7 days after ACT-451840 administration, every day during confinement or when malaria symptoms were presented and at the end of study visit (EOS). Other measures were performed if required.|Day 28 (EOS)|||mmHg||Full Range|Median
5122|NCT02223871|Secondary|Terminal Half-life [t(1/2)]|Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose|From pre-dose to144 hours after study drug adminsitration|Per protocol set||Hours||95% Confidence Interval|Geometric Mean
5123|NCT02223871|Secondary|Areas Under the Plasma Concentration-time Curve of ACT-451840|"Two AUCs were calculated using non-compartmental analysis: AUC(0-t) from pre-dose to last time-point of measure and AUC(0-inf) from pre-dose and extrapolated to infinity.~Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose"|From pre-dose to144 hours after study drug administration|||ng*h/mL||95% Confidence Interval|Geometric Mean
5124|NCT02223871|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840|tmax was directly derived from the plasma concentration-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to144 hours after study drug administration|||Hours||Full Range|Median
5125|NCT02223871|Secondary|Maximum Plasma Concentration (Cmax) of ACT-451840|Cmax was directly derived from the plasma concentrations-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to 144 hours after study drug adminsitration|||ng/mL||95% Confidence Interval|Geometric Mean
5126|NCT02223871|Primary|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated using an objective standardized approach (observed data over 48 h)"|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 5)||Ratio||95% Confidence Interval|Mean
5127|NCT02223754|Primary|Contact Lens Fitting|Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percentage of Subject Eyes|Participants||Number
5128|NCT02223754|Primary|Limbal Conjunctival Injection|The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percentage of Subject Eyes|Participants||Number
5129|NCT02223754|Primary|Bulbar Conjunctival Injection|The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||Percentage of Subject Eyes|Participants||Number
5130|NCT02223754|Primary|Corneal Staining|Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject’s inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8 - 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.||percentage of Subject Eyes|Participants||Number
5131|NCT02223754|Primary|Near Binocular Visual Acuity (LogMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
5132|NCT02223754|Primary|Intermediate Binocular Visual Acuity (LogMAR)|Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
5133|NCT02223754|Primary|Distance Binocular Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.|8- 12 Days post wear|The analysis population consists of subjects that have completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
5134|NCT02223754|Primary|Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8 -12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||units on a scale||Standard Deviation|Mean
5135|NCT02223715|Secondary|Recurrence or Not After 2 Months Follow-up|"The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment.~Unknown includes patient lost, data missing"|From the time of CDI diagnosis to 2 months follow-up|||participants|||Number
5136|NCT02223715|Secondary|Clinical Complication|This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected.|From the time of CDI diagnosis to recovery or recurrence|||participants|||Number
5137|NCT02223715|Primary|Status at the End of CDI Episode|The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.|From the time of CDI diagnosis to the end of the treatment|||participants|||Number
5138|NCT02223715|Primary|Patient Demographics|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.|At the study at the time of CDI diagnosis enrollment|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.||participants|||Number
5139|NCT02223650|Secondary|Proportion of Subjects With Near Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks|||participants|||Number
5140|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|||participants|||Number
5141|NCT02223650|Secondary|Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).||participants|||Number
5142|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|||participants|||Number
5143|NCT02223650|Secondary|Binocular Near Visual Acuity|Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.|8 weeks|||prism diopters||Standard Deviation|Mean
5144|NCT02223650|Secondary|Distance Visual Acuity|Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance|8 weeks|||prism diopters||Standard Deviation|Mean
5145|NCT02223650|Secondary|Stereoacuity|Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.|8 weeks|||log arcsecond||Standard Deviation|Mean
5146|NCT02223650|Secondary|Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).||participants|||Number
5147|NCT02223650|Secondary|Proportion of Subjects With Distance Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks|||participants|||Number
5148|NCT02223650|Secondary|Distribution of Near Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks|||participants|||Number
5149|NCT02223650|Secondary|Distribution of Distance Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks|||participants|||Number
5150|NCT02223650|Secondary|Mean Near Exotropia Control Score|"At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a triple control score, which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control."|8 weeks|||points on control score scale||Standard Deviation|Mean
5151|NCT02223650|Primary|Mean Distance Exotropia Control Score|"At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a “triple control score,” which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.~*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50."|8 weeks|||points on control score scale||Standard Deviation|Mean
5152|NCT02223260|Secondary|Global Assessment of Acceptability and Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability and acceptability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set||percentage of participants|||Number
5153|NCT02223260|Secondary|Incidence of All AEs During the Treatment Period|Percentage of patients with all adverse events (AEs) during the treatment period (including REP).|Within two days after the administration of trial medication, up to 3 days|Treated set||percentage of participants|||Number
5168|NCT02223065|Primary|Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
8745|NCT02083107|Other Pre-specified|Change in Hematocrite Value||24 hours postoperative from baseline hematocrite value|||Percentage Hematocrit||Standard Deviation|Mean
5154|NCT02223260|Secondary|Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.|"Percentage of patients with Incidence of all bleeding events(major, clinically relevant non-major (CRNM) & minor) during the treatment period (including the residual effect period).Bleeding events were classified as follow:~Major bleeding: 1) Fatal bleeding 2) Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL (20 g/L) in 24-h-period 3) Bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system 4) Bleeding that required surgical intervention in an operating suite. CRNM bleeding: 1) Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition 2) Bleeding that required medical or surgical intervention to restore haemostasis, other than in an operating suite. Minor bleeding defined as any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding."|Within two days after the administration of trial medication, up to 3 days|Treated set||Percentage of participants|||Number
5155|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters dTT (AntiFactor IIa activity) values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||R-Square|||Number
5156|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters ECT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||R-Square|||Number
5157|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters APTT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||R-Square|||Number
5158|NCT02223260|Primary|Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||ratio||Standard Deviation|Mean
5159|NCT02223260|Primary|Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||Ratio||Standard Deviation|Mean
5160|NCT02223260|Primary|Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS||ratio||Standard Deviation|Mean
5161|NCT02223260|Primary|Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS||second||Standard Deviation|Mean
5162|NCT02223260|Primary|Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS||second||Standard Deviation|Mean
5163|NCT02223260|Primary|Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS||second||Standard Deviation|Mean
5164|NCT02223260|Primary|Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate|Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate.|2 hours (h) and 12h after drug administration on day 1|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least 1 PK/PD observation and had no important Protocol violations (PVs) with respect to statistical analysis of Pharmacokinetic (PK) or Pharmacodynamic (PD ) endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5165|NCT02223065|Primary|Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
5166|NCT02223065|Primary|Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
5167|NCT02223065|Primary|Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng.h/mL||90% Confidence Interval|Geometric Mean
5169|NCT02223065|Primary|Dapagliflozin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1 to 3 (Period 1) and Day 8 to 10 (Period 2)|Evaluable PK Population||ng/mL||90% Confidence Interval|Geometric Mean
5170|NCT02223065|Primary|Saxagliptin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population||ng/mL||90% Confidence Interval|Geometric Mean
5171|NCT02222870|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 28 post-final vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
5172|NCT02222870|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 28 post-final vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
5173|NCT02222870|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
5174|NCT02222870|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
5175|NCT02222870|Primary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|"Solicited Injection-site: 6 to < 36 months - Tenderness, Erythema, and Swelling; 3 to < 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to < 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to < 9 years - Fever, Headache, Malaise, and Myalgia.~Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-any injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
5176|NCT02222818|Secondary|Percentage of Effective CRT Pacing During AF (Superiority Test)|The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.||percentage of effective CRT pacing||Standard Deviation|Mean
5177|NCT02222818|Primary|Percentage of Effective CRT Pacing During AF (Non-inferiority Test)|The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.||percentage of effective CRT pacing||Standard Deviation|Mean
5178|NCT02222558|Primary|Percentage of Responders|Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.|Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24|Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.||percentage of subjects|||Number
5179|NCT02222207|Secondary|Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.||percentage of participants|||Number
5180|NCT02222207|Secondary|Percentage of Participants With Individual Changes in BCVA of Greater Than Equal to (>=) 0 Letters of Vision From Study Week 4 to Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Week 4, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.||percentage of participants|||Number
5181|NCT02222207|Primary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A|Participants were assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS protocol. ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.||Score on scale||Standard Deviation|Mean
5260|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Five-year Period From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)|||participants|||Number
5182|NCT02222207|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A|Participants will be assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS. The participant’s ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 4|Full Analysis Set (FAS): included participants who received at least one dose of study medication.||Score on scale||Standard Deviation|Mean
5183|NCT02222181|Secondary|Diastolic Blood Pressure|Diastolic pressure <90 mmHg|weekly|||mmHg||Standard Deviation|Mean
5184|NCT02222181|Secondary|Glycemia|Normal levels: 70-99mg/dL; diabetic: >121mg/dL.|two months|||mg/dL||Standard Deviation|Mean
5185|NCT02222181|Secondary|Triglycerides|Normal level: 150mg/dL|three months|||mg/dL||Standard Deviation|Mean
5186|NCT02222181|Secondary|Total Cholesterol|Total Cholesterol <200 mg/dL|Total Cholesterol|||mg/dL||Standard Deviation|Mean
5187|NCT02222181|Secondary|Systolic Blood Pressure|Systolic pressure <140 mmHg|weekly|||mmHg||Standard Deviation|Mean
5188|NCT02222181|Primary|Clinical Dementia Rating (CDR)|CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)|six months|||score||Standard Deviation|Mean
5189|NCT02222181|Primary|Mini-mental State Examination (MMEE)|MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)|six months|||score||Standard Deviation|Mean
5190|NCT02222129|Secondary|Time to First Opioid Use.|Time to first opioid use.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||||
5191|NCT02222129|Secondary|Length of Hospital Stay.|Length of hospital stay.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||||
5192|NCT02222129|Secondary|Visual Analog Pain Scores.|Visual analog pain scores.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||||
5193|NCT02222129|Primary|Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay|Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||mg (morphine equivalents)||Inter-Quartile Range|Median
5194|NCT02221947|Other Pre-specified|Pharmacokinetic Parameters (Cmax, Tmax, AUClast, AUCinf, λz, T1/2, CL, Vz) of Bryostatin.|Preliminary evaluation of pharmacokinetics, pharmacodynamics and to correlate the changes in protein kinase C (PKC) with plasma levels of bryostatin and with improvement in cognitive function in patients with AD. PBMC PKC activity at baseline (within 30 minutes prior to study drug infusion), during the infusion (30 and 60 min post the start of study drug infusion), and at 80 min, 2, 3, 6, 24, 48, 72 hrs and 2 weeks post start of study drug infusion. Blood will be drawn at baseline (within 30 minutes prior to study drug infusion), during the infusion (15, 30, and 60 min post start of study drug infusion), and at 80 min, 2, 3, 6, 12, 24, 36, 48, 72 hrs and 2 weeks post start of study drug infusion to assess pharmacokinetic parameters (Cmax, Tmax, AUClast, AUCinf, λz, T1/2, CL, Vz) of bryostatin.|Within 2 weeks of study drug dosing||||||
5195|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|MMSE-2 (Mini-Mental® State Examination, 2nd Edition) at 3 and 72 hours, and 2 weeks post start of study drug infusion|within 2 weeks of study drug dosing||||||
5196|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|CDR, Clinical Dementia Rating Sum of Boxes (CDR-SB) and individual items at 2 weeks post start of study drug infusion|within 2 weeks of study drug dosing||||||
5197|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|Digit Symbol Coding at 3, 24 and 48 hours and 2 weeks post start of study drug infusion|within 2 weeks of study drug dosing||||||
5198|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|HVLT-R (Hopkins Verbal Learning Test–Revised™ (HVLT-R™) delayed free recall, HVLT-R delayed cued recall, HVLT-R delayed recognition recall, RBANS figure recall at 48 hour post start of study drug infusion. HVLT-R delayed free recall, HVLT-R delayed cued recall, HVLT-R delayed recognition recall, RBANS figure recall at 24 hours and 2 weeks post start of study drug infusion HVLT-R delayed free recall, HVLT-R delayed cued recall, HVLT-R delayed recognition recall of stimuli presented 48 hours post study drug infusion, as assessed 72 hours post start of study drug infusion.|Within 2 weeks of study drug dosing||||||
5199|NCT02221947|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Evaluate the safety and tolerability of bryostatin 1 (hereinafter referred to as bryostatin) in patients with Alzheimer's Disease (AD) following a single intravenous (IV) dose.|Within 2 weeks of study drug dosing|||event|||Number
5200|NCT02221648|Secondary|Number of Subjects Showing Improvement on Quality of Life Scale for Pain|The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.|6 weeks|||participants|||Number
5201|NCT02221648|Secondary|Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment"|6 weeks|||participants|||Number
5202|NCT02221648|Primary|Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)|The primary outcome measure in this protocol is the proportion of subjects that have VAS <4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by “no pain” (score of 0) and “worst imaginable pain” (score of 10).|6 weeks|||participants|||Number
5203|NCT02220998|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
5204|NCT02220998|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
5205|NCT02220998|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|||percentage of participants||95% Confidence Interval|Number
5206|NCT02220998|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
5207|NCT02220998|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
5208|NCT02220998|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
5209|NCT02220920|Secondary|"Percentage of Participants With Adverse Events and Hypoglycemia and Blood Glucose Decreased"||Week 16|"Safety analysis set. Safety Population reflects the as treated population, and one Canagliflozin (TA-7284) + Insulin participant actually received Placebo + Insulin."||percentage of participants|||Number
5210|NCT02220920|Secondary|Change in Blood Pressure||baseline and Week 16|Full analysis set, last observation carried forward||mmHg||Standard Error|Least Squares Mean
5211|NCT02220920|Secondary|Percent Change in Body Weight||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of body weight at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."||percent change||Standard Error|Least Squares Mean
5212|NCT02220920|Secondary|Change in Fasting Plasma Glucose||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of fasting plasma glucose at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."||mg/dL||Standard Error|Least Squares Mean
5213|NCT02220920|Primary|Change in HbA1c From Baseline||baseline and Week 16|Full analysis set, last observation carried forward||Percent||Standard Error|Least Squares Mean
5214|NCT02220764|Other Pre-specified|Number of of Fixed Dental Prostheses (FDPs) With Rough Surface|Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.|3 years|||FDPs with rough surface|||Number
5215|NCT02220764|Secondary|Number of Fixed Dental Prostheses (FDPs) With Chip/s|Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.|3 years|||FDPs with chip/s|||Number
5216|NCT02220764|Primary|Number of Fixed Dental Prostheses (FDPs) With Failure|"Failure was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period."|3 years|||FDPs with failure|||Number
5217|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.||seconds||Standard Deviation|Mean
5218|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.||seconds||Standard Deviation|Mean
5237|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
5219|NCT02219997|Primary|Change in Braking Reaction Time From No-glare to Glare|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, up to Day 30|This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).||seconds||Standard Deviation|Mean
5220|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring the extent of negative attitudes about the future (pessimism) as perceived by adolescents and adults. The BHS consists of 20 true-false statements. Each of the 20 statements is scored 1 or 0. Of the 20 true-false statements, 9 are keyed FALSE, and 11 are keyed TRUE to indicate endorsement of pessimism about the future. The item scores are summed to yield a total score that can range from 0 to 20 with higher scores indicating greater hopelessness.|Baseline; Posttreatment Weeks 4 and 24|Full Analysis Set||units on a scale||Standard Deviation|Mean
5221|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-report instrument for measuring the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The item scores are summed to yield a derived total score that can range from 0 to 63 with lower values indicating less depression.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
5222|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment|Activity impairment was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall activity impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from performing regular activities).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
5223|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment|Impairment in overall work productivity was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall work impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from working).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
5224|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
5225|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)|The CLDQ-HCV is a disease-specific questionnaire measuring health-related quality of life. CLDQ-HCV scores are calculated using participant responses to 29 questions divided into 4 domains: Activity/Energy, Emotion, Worry, and Systemic. An overall CLDQ-HCV score is calculated by taking the mean of all domain scores. Overall CLDQ-HCV scores range between 1 and 7, with higher scores representing better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
5226|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.|Baseline; Posttreatment (PT) Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
5227|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
5253|NCT02217878|Secondary|P2Y12 Reaction Units (PRU) Assessed by VerifyNow|It will be assessed in at least 30% of study participants (with 1:1 ratio between morphine and placebo arms) in all predefined time points. Measurements will not be performed in patients treated with GP IIb/IIIa receptor inhibitors.|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||||
5228|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
5229|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
5230|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
5231|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
5232|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."||units on a scale||Standard Deviation|Mean
5233|NCT02219685|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4, 12, and 24 weeks after stopping study treatment with LDV/SOF, respectively.|Posttreatment Weeks 4, 12, and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
5234|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
5235|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
5236|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
5254|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units/Min Assessed by Multiple Electrode Aggregometry|It will be assessed in all predefined time points in all study participants except those treated with GP IIb/IIIa receptor inhibitors.|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||||
5238|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
5239|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal myoinositol was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set||ratio||Standard Deviation|Mean
5240|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal choline was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set||ratio||Standard Deviation|Mean
5241|NCT02219685|Primary|Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal N-acetylaspartate (NAA) + N-acetylaspartylglutamate (NAAG) was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.||ratio||Standard Deviation|Mean
5242|NCT02219503|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
5243|NCT02219503|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
5244|NCT02219503|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|"Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.~The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis."|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
5245|NCT02218268|Primary|Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.|Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.|From baseline to one hour then 2 hours|||Percent of Pulse Pressure||95% Confidence Interval|Mean
5246|NCT02217982|Other Pre-specified|Number of Participants With Pre-Existing GI Conditions|The tertiary objective is to gather further data regarding pre-existing conditions (GE reflex, gastric bypass, stomach ulcer, etc) and their possible relationship to GI symptoms when initiating DMF.|7 Weeks||||||
5247|NCT02217982|Secondary|Diarrhea Reduction|The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.|7 Weeks||||||
5248|NCT02217982|Primary|Reported GI Symptoms|The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.|7 Weeks|Trial was shut down early as not enough patients qualified with GI symptoms their first 2 weeks after initiating DMF therapy||Participants|||Count of Participants
5249|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VASP, MEA and VerifyNow||12 hours||||||
5250|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VASP, MEA and VerifyNow||2 hours||||||
5251|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6)||prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose||||||
5252|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h)||prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose||||||
5255|NCT02217878|Secondary|Platelet Reactivity Index (PRI) Assessed by VASP Assay|It will be assessed in all study participants in all predefined time points.|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||||
5261|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Age Group From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)|||participants|||Number
5262|NCT02216695|Primary|Incidence of AKI-D From 1998-9 to 2012-13|The population incidence of acute kidney injury requiring dialysis (AKI-D) was calculated using mid-year population of England in each year from 1998 to 2013 and expressed as people per million population. This was calculated by dividing number of cases by mid year population of England and multiplying by million.|15-years|||cases per million population|||Number
5263|NCT02216695|Primary|Secular Trends in the Mortality After Acute Kidney Injury From 1998 to 2013|A retrospective cohort study of patients with acute kidney injury in England over a period of fifteen years, describing the trends in the mortality of acute kidney injury.|Participants will be followed for the duration of hospital stay (average of 15 days)|||participants|||Number
5264|NCT02216422|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
5265|NCT02216422|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
5266|NCT02216422|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants||95% Confidence Interval|Number
5267|NCT02216097|Secondary|Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were QTc absolute value >=450 milliseconds (msec) or QTc absolute change >=30 msec.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
5268|NCT02216097|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
5269|NCT02216097|Secondary|Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); chemistry (glucose); urinalysis (dipstick) (urine pH, urine glucose, urine protein, urine blood, urine ketones, urine bilirubin, urine nitrite, urine leukocyte esterase); urinalysis microscopy (urine red blood cell, urine white blood cell, urine bacteria). Only parameters with abnormal values were reported.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
5270|NCT02216097|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration that were absent before treatment or that worsened relative to pretreatment state. AEs included non-serious AEs and SAEs.|Baseline up to 28 days after last study drug administration (Day 35)|The safety analysis population included all participants who received study medication.||participants|||Number
5271|NCT02216097|Secondary|Number of Participants With Abnormal Physical Examination Findings|The full physical examination included head, ears, eyes, nose, mouth, skin, heart, and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline to up to Day 18|The safety analysis population included all participants who received study medication.||participants|||Number
5272|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left Amygdala|Difference measured in BOLD fMRI percent signal change in the left amygdala in fearful versus neutral faces during face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.|||||
5292|NCT02214186|Other Pre-specified|Urine Output During Cesarean Section in Severe Pre-eclampsia|Urine output during cesarean section in severe pre-eclampsia under two different regimes of hydration (restrictive and liberal)|urine output during cesarean section (an average of 60 minutes)|||ml/h||Standard Deviation|Mean
8746|NCT02083107|Secondary|Incidence of Adverse Effects||24 hours|||no. of cases experiencing side effects|||Number
5273|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right Amygdala|Difference measured in BOLD fMRI percent signal change in the right amygdala in fear versus neutral faces during the emotional face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.|||||
5274|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)|Difference measured in BOLD fMRI percent activation in the bilateral vmPFC during the fear extinction recall phase of the fear extinction paradigm.|Baseline, Day 2|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.|||||
5275|NCT02216097|Primary|Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral Amygdala|Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance that resulted in data integrity and quality issues.|||||
5276|NCT02214225|Secondary|The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.|The number of participants reporting Serious Adverse Events for 6 months following vaccination.|For 6 months following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
5277|NCT02214225|Secondary|The Frequency and Severity of Unsolicited AEs.|The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
5278|NCT02214225|Secondary|The Frequency of Cellulitis-like Reaction and Cellulitis.|The number of subjects experiencing at least one episode of each event.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
5279|NCT02214225|Secondary|The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).|The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.|For 7 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.||participants|||Number
5280|NCT02214225|Secondary|Seroconversion Rates|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants||95% Confidence Interval|Number
5281|NCT02214225|Secondary|Seroprotection Rates Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants||95% Confidence Interval|Number
5282|NCT02214225|Secondary|Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Fold Change Titer (GMFI)||95% Confidence Interval|Geometric Mean
5283|NCT02214225|Secondary|Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||95% Confidence Interval|Geometric Mean
5329|NCT02212977|Secondary|Healing-incision Cosmesis Score by Visual Analogue Scale|To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.|3 months|Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.||units on a scale||Standard Deviation|Mean
5284|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants analyzed|||Number
5285|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).|"Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.~(GMT dispersion values are based on unadjusted GMT values.)"|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||Full Range|Geometric Mean
5286|NCT02214225|Secondary|The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).|Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants analyzed|||Number
5287|NCT02214225|Secondary|Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).|"Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.~Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint."|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||Full Range|Geometric Mean
5288|NCT02214225|Primary|The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.|SCR (defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||percentage of participants|||Number
5289|NCT02214225|Primary|Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).|Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.||Titer||Full Range|Geometric Mean
5290|NCT02214186|Primary|Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index|Renal dysfunction was stratified by the Acute Kidney Injury Network (AKIN) index in three stages, in terms of creatinine increase from baseline: stage 1 included an interval of 150–200%, stage 2 200%–300%, and stage 3 more than 300% or hemodialysis|Postoperative renal dysfunction|||participants|||Number
5291|NCT02214186|Secondary|Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare activated partial thromboplastin time (APPT) and relation with control (R) in the restrictive and liberal groups.~APPT is a laboratory test that evaluates the efficiency of the intrinsic pathway of coagulation. The unit of measure is seconds and the results are presented as relation (R) with control."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (R) with control patients.||ratio||Standard Deviation|Mean
6279|NCT02169115|Secondary|To Assess Long-term Effects of Omalizumab in UF Patients|To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed|112 days||||||
5293|NCT02214186|Secondary|International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare International Normalized Ratio (INR) of Prothrombin Time (PT) in the restrictive and liberal groups in preoperative, first and second day postoperative.~PT is expressed in seconds and the entered values represented the INR of PT among study participants and a control population."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (INR) with control patients.||ratio||Standard Deviation|Mean
5294|NCT02214186|Secondary|Platelets in Restrictive Fluid Management of Severe Preeclampsia|Compare platelets count in the restrictive and liberal groups during the first and second post-operative days.|preoperative, first and second day postoperative|||thrombocytes/mm3||Standard Deviation|Mean
5295|NCT02214186|Secondary|Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration|Proteinuria in severe pre-eclampsia submitted to cesarean section under different regimes of hydration. Analyses in pre-operative and post-operative period.|Proteinuria in severe pre-eclampsia in in pre-operative and post-operative period|||g/dl||Standard Deviation|Mean
5296|NCT02214186|Secondary|Cystatin C as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (Cystatin C) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative|||mg/L||Standard Deviation|Mean
5297|NCT02214186|Secondary|Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (NGAL) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative|||mg/L||Standard Deviation|Mean
5298|NCT02214186|Primary|Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy|Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.|preoperative, first and second day postoperative|||mg/dl||Standard Deviation|Mean
5299|NCT02213510|Secondary|Patient Incision Pain|Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).|3 months|||units on a scale||Standard Deviation|Mean
5300|NCT02213510|Secondary|Patient Incision Pain|At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).|2 weeks|||units on a scale||Standard Deviation|Mean
5301|NCT02213510|Secondary|Patient Incision Pain|At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).|1 day (discharge)|||units on a scale||Standard Deviation|Mean
5302|NCT02213510|Secondary|Patient Rating of Scar|"At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months|||units on a scale||Standard Deviation|Mean
5303|NCT02213510|Secondary|Patient Satisfaction With Scar|"Patient will complete questionnaires that includes assessments of the following:~Pain~Closure Method Comfort~Closure Method Satisfaction~Scar Satisfaction~Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months|||units on a scale||Standard Deviation|Mean
5304|NCT02213510|Secondary|Patient Comfort|At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).|2 weeks|||units on a scale||Standard Deviation|Mean
5305|NCT02213510|Secondary|Surgeon Satisfaction With Scar|"At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months|||units on a scale||Standard Deviation|Mean
5306|NCT02213510|Secondary|Surgeon Evaluation Based on the Wound Evaluation Scale (WES)|"The surgeon will complete an assessment of the following:~Closure Method Satisfaction~Scar Satisfaction~Wound Healing as judged by Wound Evaluation Scale~Scale rated on 1 (least favorable) to 6 (most favorable)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 Months|||units on a scale||Standard Deviation|Mean
5307|NCT02213510|Secondary|Surgeon Wound Evaluation Scale (WES)|At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).|2 weeks|||units on a scale||Standard Deviation|Mean
5308|NCT02213510|Primary|Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)|Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).|3 Months|Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.||mm||Standard Deviation|Mean
5309|NCT02213510|Primary|Overall Closure Time|Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)|2 weeks|||seconds||Standard Deviation|Mean
5310|NCT02213250|Secondary|Number of Subjects With Thrombogenicity||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
5311|NCT02213250|Secondary|Number of Participants With Allergic Reactions||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
5312|NCT02213250|Secondary|Number of Participants With Inhibitor Development||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
5313|NCT02213250|Secondary|Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)||Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
5314|NCT02213250|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)|Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.|Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.||Participants|||Number
5315|NCT02213250|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.|From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis set was defined as all participants who received at least 1 dose of BeneFIX.||Particpants|||Number
5316|NCT02213250|Primary|Incremental Recovery|Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.|Pre-dose, 0.25, 0.5 and 1 hour post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||(IU/dL)/(IU/Kg)||Geometric Coefficient of Variation|Geometric Mean
5317|NCT02213250|Primary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
5318|NCT02213250|Primary|Plasma Decay Half-Life (t½)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||hours||Standard Deviation|Mean
5319|NCT02213250|Primary|Mean Residence Time (MRT)|AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||hours||Geometric Coefficient of Variation|Geometric Mean
5320|NCT02213250|Primary|Terminal Phase Rate Constant (Kel)|Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||1/hr||Geometric Coefficient of Variation|Geometric Mean
5321|NCT02213250|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||milliliter/kilogram (mL/kg)||Geometric Coefficient of Variation|Geometric Mean
5322|NCT02213250|Primary|Time to Reach Cmax (Tmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||hours||Full Range|Median
5323|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||IU*hr/ml||Geometric Coefficient of Variation|Geometric Mean
5324|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||IU*hour/milliliter (IU*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
5325|NCT02213250|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.||IU/milliliter (IU/mL)||Geometric Coefficient of Variation|Geometric Mean
5326|NCT02213055|Primary|Number of Participants Free of Live Head Lice and Free of Viable Eggs|"A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.~At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice."|Day after first treatment and Day 14 of study|There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.||Participants|||Number
5327|NCT02212977|Secondary|Closure Materials Cost|Per unit cost for suture and octylcyanoacrylate|Baseline|||dollars|||Number
5328|NCT02212977|Secondary|Closure Time|To compare closure time and associated costs between these two methods of skin closure.|Baseline|||minutes||Standard Deviation|Mean
8747|NCT02083107|Secondary|Incidence of Wound Sepsis||upto one week|||no. of cases experiencing wound sepsis|||Number
5330|NCT02212977|Primary|Number of Participants With Complication of Infection|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months|||participants|||Number
5331|NCT02212977|Primary|Number of Participants With Complication of Wound Dehiscence|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months|||participants|||Number
5332|NCT02212834|Primary|Number of Breast Cancers Detected|Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI|12 months post surveillance exam|||cancers detected|exams||Number
5333|NCT02212301|Primary|Time Controlled Visual Acuity|The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17” LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3” LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.|8 hours post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).||LogMAR||Standard Deviation|Mean
5334|NCT02212301|Primary|Tear Film Kinetics|The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.|8 hour post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.||Seconds||Standard Deviation|Mean
5335|NCT02212197|Secondary|Mean Prostate Specific Antigen (PSA) Concentration||Days 0-126|||ng/mL||Inter-Quartile Range|Median
5336|NCT02212197|Secondary|Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)||Days 0-126|||ng/dL||Inter-Quartile Range|Median
5337|NCT02212197|Secondary|Time (Days) to Testosterone Recovery After Dose 3||Days 56-126|||days||Standard Deviation|Mean
5338|NCT02212197|Primary|Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3||Days 0-28 and Days 56-84|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
5339|NCT02212197|Primary|Apparent Terminal Half-life (t½) for Dose 1 and Dose 3||Days 0-28 and Days 56-84|||hour||Standard Deviation|Mean
5340|NCT02212197|Primary|Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3||84 days|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5341|NCT02212106|Secondary|The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The number of subjects experiencing at least one SAE.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Number of subjects|||Number
5342|NCT02212106|Secondary|The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
5343|NCT02212106|Secondary|The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
5344|NCT02212106|Secondary|The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
5345|NCT02212106|Secondary|The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.|Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.||Percentage of subjects|||Number
5346|NCT02212106|Secondary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.||Percentage of subjects|||Number
5347|NCT02212106|Primary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.||Percentage of subjects|||Number
5348|NCT02212028|Secondary|Platelet Reactivity Index (PRI)|The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.||PRI||95% Confidence Interval|Least Squares Mean
5349|NCT02212028|Primary|P2Y12 Reaction Units (PRU)|The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.||PRU||95% Confidence Interval|Least Squares Mean
5350|NCT02210091|Post-Hoc|Pharmacokinetics (PK): Plasma Half-life Ratio of BAX 855 to ADVATE|This is a descriptive summary of the ratio of plasma half-life in the same subject for BAX 855 compared to ADVATE based on the final covariate model (first observation tabulation).|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||hours (hr)||Full Range|Mean
5351|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - Chromogenic Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.~For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category Chromogenic assay - BAX 855~For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.~Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 Exposure Days [EDs], whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6.||IU/dL : IU/kg||Standard Deviation|Mean
5352|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - One Stage Clotting Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.~For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category One stage clotting assay - BAX 855~For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.~Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 EDs, whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6||IU/dL : IU/kg||Standard Deviation|Mean
5353|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A non-compartmental model approach was implemented to analyze IR data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||IU/dL : IU/kg||Standard Deviation|Mean
5360|NCT02210091|Secondary|Positive Post-baseline Binding Antibodies to Factor VIII (FVIII), Polyethylene Glycol-Factor VIII (PEG-FVIII), PEG and Chinese Hamster Ovary (CHO) Proteins|"Binding antibodies to FVIII and PEG-FVIII, as well as to PEG, were measured using enzyme-linked immunosorbent assay (ELISA). Both immunoglobulin G (IgG) and immunoglobulin M (IgM) binding antibodies for FVIII, BAX 855, and PEG were tested at each study visit. Testing for binding antibodies to CHO was performed on citrate-anti-coagulated plasma using an ELISA employing polyclonal anti-human IgG antibodies.~This outcome measure includes antibodies that were transient (antibody developed after exposure to BAX 855 but not present at study termination/completion) and pre-existent (antibody originally present before exposure to BAX 855)."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set: Data not available for 1 participant in the 6 to <12 years group as participant was prematurely withdrawn from study.||participants|||Number
8748|NCT02083107|Secondary|Need for Postoperative Blood Transfusion||average 24 hours|||participants|||Number
5354|NCT02210091|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||litre (L)||Standard Deviation|Mean
5355|NCT02210091|Secondary|Pharmacokinetics (PK): Plasma Half-life (T1/2)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||hours (hr)||Standard Deviation|Mean
5356|NCT02210091|Secondary|Pharmacokinetics (PK): Clearance (CL)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||L/hr||Standard Deviation|Mean
5357|NCT02210091|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set||hours (hr)||Standard Deviation|Mean
5358|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion Per Dose, (AUC0-∞/Dose)||(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|The PK parameters were derived using a non-compartmental estimation approach using a flexible sampling design to provide point and interval estimates for summary PK parameter using a batch method. AUC/Dose is not a standard output parameter so this calculation was not done.|||||
5359|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion (AUC0-∞)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set.||IU•hr/L||Standard Deviation|Mean
5378|NCT02209766|Primary|Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)|Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)|from first dosing (Day1) until follow-up (Day25)|||subjects|||Number
5379|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
5380|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
5361|NCT02210091|Secondary|Number of Clinically Significant Changes in Clinical Laboratory Parameters (Hematology, Clinical Chemistry, Lipids)|"The HEMATOLOGY PANEL consisted of complete blood count: hemoglobin, hematocrit, erythrocytes (ie, red blood cell count), leukocytes (ie, white blood cell count) with differential (ie, basophils, eosinophils, lymphocytes, monocytes, and neutrophils), mean corpuscular volume, mean corpuscular hemoglobin concentration, and platelet count.~The CLINICAL CHEMISTRY PANEL consisted of sodium, potassium, chloride, bicarbonate, total protein, albumin, ALT, aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, and glucose.~The LIPID PANEL consisted of cholesterol, very low density lipoprotein, low density lipoprotein, high density lipoprotein, and triglycerides.~Only clinically significant (CS) changes are provided for the individual laboratory parameters."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||clinically significant findings|||Number
5362|NCT02210091|Secondary|Number of Clinically Significant Changes in Vital Signs|"Vital signs: body temperature (°C), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (mmHg). For each abnormal vital sign value, the investigator had to decide if he/she deemed this to be an adverse event.~Category abbreviation CS = Clinically Significant"|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||clinically signficant vital signs|||Number
5363|NCT02210091|Secondary|Non-serious Adverse Events Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||adverse events|||Number
5364|NCT02210091|Secondary|Serious Adverse Events (SAEs) Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.||serious adverse events|||Number
5365|NCT02210091|Secondary|Hemostatic Efficacy Rating for Bleeding Episodes Treated With BAX 855 at Resolution of Bleed|"Rating Scale for Treatment of Bleeding Episodes (BEs) (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the Full Analysis Set who had treated bleeding episodes.||bleeding episodes|bleeding episodes||Number
5366|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.||IU/kg|bleeding episodes|Standard Deviation|Mean
5367|NCT02210091|Secondary|Consumption of BAX 855: Number of Infusions Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.||infusions||Standard Deviation|Mean
5368|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||IU/kg||Standard Deviation|Mean
5369|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||IU/kg||Standard Deviation|Mean
5370|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||infusions per year||Standard Deviation|Mean
5371|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.||infusions per month||Standard Deviation|Mean
5372|NCT02210091|Secondary|Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during the prophylaxis period was assessed based upon each individual bleeding episode, spontaneous or traumatic, recorded in the participant´s diary and/or recorded in the physician/nurse/study site notes.~The annualized bleeding rate was analyzed using a generalized linear model framework assuming a negative binomial distribution with a logarithmic link function and presence or absence of target joints and age cohort as covariates and duration of the observation period in years as offset. Point estimates for the mean and 95% confidence intervals are presented."|During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Full Analysis Set: All participants who received at least 1 dose of BAX 855 in either PK or prophylaxis part of study||bleeding episodes per year||95% Confidence Interval|Mean
5373|NCT02210091|Primary|Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)|Inhibitory antibodies to FVIII were measured using the Nijmegen modification of the Bethesda assay. Incidence of an FVIII inhibitory antibody was defined as an inhibitor level ≥0.6 Bethesda units [BU].|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the BAX 855 Safety Analysis Set who developed an inhibitor at any time plus participants who did not develop an inhibitor, had 50 or more exposure days (EDs) to BAX 855 and had FVIII Inhibitory test results after 50 EDs.||participants|||Number
5374|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
5375|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
5376|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
5377|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
5381|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25|||h||Full Range|Median
5387|NCT02209506|Secondary|CLr: Renal Clearance of MLN3126 and Its Metabolite|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr). M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.|||||
5388|NCT02209506|Secondary|Fe (0-4): Fraction of Dose of MLN3126 and Its Metabolite Excreted Unchanged in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.|||||
5389|NCT02209506|Secondary|Ae (0-4): Amount of MLN3126 and Its Metabolite Excreted in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.|||||
5390|NCT02209506|Secondary|Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ratio||Standard Deviation|Mean
5391|NCT02209506|Secondary|Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ratio||Standard Deviation|Mean
5392|NCT02209506|Secondary|Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ratio||Standard Deviation|Mean
5393|NCT02209506|Secondary|Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15|M-I is the inactive metabolite of MLN3126.|Day 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng/mL||Standard Deviation|Mean
5394|NCT02209506|Secondary|Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1|M-I is the inactive metabolite of MLN3126.|Day 1: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng/mL||Standard Deviation|Mean
5395|NCT02209506|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||hours||Standard Deviation|Mean
5396|NCT02209506|Secondary|CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)|M-I is the inactive metabolite of MLN3126.|Day 1: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||liter per hour (L/hr)||Standard Deviation|Mean
5397|NCT02209506|Secondary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng*hr/mL||Standard Deviation|Mean
5398|NCT02209506|Secondary|AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng*hr/mL||Standard Deviation|Mean
5399|NCT02209506|Secondary|AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||ng*hr/mL||Standard Deviation|Mean
5400|NCT02209506|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||nanogram*hour per milliliter (ng*hr/mL||Standard Deviation|Mean
5401|NCT02209506|Secondary|Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||hours||Full Range|Median
5610|NCT02201940|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
5402|NCT02209506|Secondary|Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
5403|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by Takeda Global Research and Development Center, Inc. (TGRD). Criteria for markedly abnormal vital signs included body temperature, systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
5404|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistry, and urinalysis, during the treatment period.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
5405|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Electrocardiogram Measurements at Least Once Post Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
5406|NCT02209506|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)|A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
5407|NCT02209454|Secondary|t1/2|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h||95% Confidence Interval|Geometric Mean
5408|NCT02209454|Secondary|Tmax|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h||Full Range|Median
5409|NCT02209454|Primary|AUC(0-t)|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 125.00% for AUC(0-t).|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h*ng/mL||95% Confidence Interval|Geometric Mean
5410|NCT02209454|Secondary|AUC(0-∞)|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||h*ng/mL||95% Confidence Interval|Geometric Mean
5411|NCT02209454|Primary|Cmax|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 133.00% for Cmax.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).||ng/mL||95% Confidence Interval|Geometric Mean
5412|NCT02209181|Secondary|Subject Global Evaluation|How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).|Completed at hour 12 or at time of the first rescue medication (hours post dose).|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||percentage of participants|||Number
5413|NCT02209181|Secondary|Duration of Pain Relief After Dosing (Time to Rescue Medication)|Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given.|Completed at time of the first rescue medication (hours post dose), estimated up through Day 2|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||minutes||95% Confidence Interval|Median
5414|NCT02209181|Secondary|Pain Relief (PAR) Scores at 24 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5415|NCT02209181|Secondary|Pain Relief (PAR) Scores at 16 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
8749|NCT02083107|Secondary|Need for Extra Analgesics||average 24 hours|||participants|||Number
5416|NCT02209181|Secondary|Pain Relief (PAR) Scores at 12 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5417|NCT02209181|Secondary|Pain Relief (PAR) Scores at 11 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5418|NCT02209181|Secondary|Pain Relief (PAR) Scores at 10 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5419|NCT02209181|Secondary|Pain Relief (PAR) Scores at 9 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5420|NCT02209181|Secondary|Pain Relief (PAR) Scores at 8 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5421|NCT02209181|Secondary|Pain Relief (PAR) Scores at 7 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5422|NCT02209181|Secondary|Pain Relief (PAR) Scores at 6 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5423|NCT02209181|Secondary|Pain Relief (PAR) Scores at 5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5424|NCT02209181|Secondary|Pain Relief (PAR) Scores at 4 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5425|NCT02209181|Secondary|Pain Relief (PAR) Scores at 3 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5426|NCT02209181|Secondary|Pain Relief (PAR) Scores at 2 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5427|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1.5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5428|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1 Hour Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5429|NCT02209181|Secondary|Pain Relief (PAR) Scores at 45 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5430|NCT02209181|Secondary|Pain Relief (PAR) Scores at 30 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5431|NCT02209181|Secondary|Pain Relief (PAR) Scores at 15 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5432|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5433|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5434|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
6532|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Day 89-90|||minutes||Standard Deviation|Least Squares Mean
5435|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5436|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5437|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5438|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5439|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5440|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5441|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5442|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5443|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5444|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5445|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5446|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5447|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5448|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5449|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
8750|NCT02083107|Secondary|Time to Resume Bowel Habits||average 24 hours|||hours||Standard Deviation|Mean
5450|NCT02209181|Primary|Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)|Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).|6 Hours|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
5451|NCT02209064|Other Pre-specified|Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System|Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey|Access through end of procedure|||participants|||Number
5452|NCT02209064|Secondary|Percentage of Participants With a Pericardial Effusion of >80ml|Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.|Access through discharge/approximately 4 days|||percentage of participants|||Number
5453|NCT02209064|Secondary|Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System|EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.|access through procedure completion|||percentage of patients|||Number
5454|NCT02209064|Primary|Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System|EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.|Through discharge / approx 4 days|Percentage of patients in whom epicardial access was successful using the EpiAccess system. Successful access is defined as the ability to introduce a guide wire into the epicardial space.||percentage of patients|||Number
5455|NCT02207907|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.|The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth|6,12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Mean
5456|NCT02207907|Secondary|Bleeding Index at 6, 12 and 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|6, 12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a Scale||Standard Error|Mean
5457|NCT02207907|Secondary|Modified Gingival Index (MGI) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Mean
5458|NCT02207907|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks.|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||number of gingival bleeding sites||Standard Error|Mean
5468|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.|During a 3 day (Days 0-2) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
8779|NCT02081079|Secondary|Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12||Baseline; Weeks 2, 4, 8, and 12|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
5459|NCT02207907|Primary|Modified Gingival Index (MGI) at 24 Weeks|The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Mean
5460|NCT02207907|Primary|Number of Gingival Bleeding Sites at 24 Weeks|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.||number of gingival bleeding sites||Standard Error|Mean
5461|NCT02207829|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis||Liter||Standard Error|Least Squares Mean
5462|NCT02207608|Primary|Visual Analogue Scale for Pain|1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)|Before and after six weeks of treatment (end of induction course)|||units on a scale||Standard Deviation|Mean
5463|NCT02207478|Secondary|The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone|Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.|Up to half year|||seconds||Standard Deviation|Mean
5464|NCT02207478|Primary|The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB|The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.|Up to half year|||participants|||Number
5465|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
5466|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
5467|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
5469|NCT02207413|Secondary|Duration of Solicited General AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Days||Full Range|Median
11252|NCT01989195|Secondary|Significant Cardiovascular Event|Hospitalization and procedures for chest pain, arrhythmias, and all-cause mortality|1 year|||participants|||Number
5470|NCT02207413|Secondary|Duration of Solicited Local AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Days||Full Range|Median
5471|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>)39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
5472|NCT02207413|Secondary|Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF.~Data of 2 independent groups were pooled."|During the 2 days (Day 0-Day 1) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to <5 years, with at least one vaccine administration documented.||Subjects|||Number
5473|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
5474|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.~Fever = temperature of ≥ 38°C/100.4°F by any route"|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
5475|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Fold increase||95% Confidence Interval|Geometric Mean
5476|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
5477|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
5478|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Titers||95% Confidence Interval|Geometric Mean
6869|NCT02144259|Primary|Weight|Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups|6 months from postpartum (baseline)|||percent weight lost||Standard Deviation|Mean
5479|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Fold increase||95% Confidence Interval|Geometric Mean
5480|NCT02207413|Secondary|Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
5481|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Subjects|||Number
5482|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|The analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were avail||Titers||95% Confidence Interval|Geometric Mean
5483|NCT02207413|Secondary|Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses.|Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
5484|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0).~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Fold increase||95% Confidence Interval|Geometric Mean
5485|NCT02207413|Secondary|Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
5486|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Subjects|||Number
5538|NCT02204748|Primary|Femoro-tibial Kinematics - Ramp Down|Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative|||degrees||Standard Deviation|Mean
5539|NCT02204748|Primary|Femoro-tibial Kinematics - Gait|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative|||degrees||Standard Deviation|Mean
5487|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.||Titers||95% Confidence Interval|Geometric Mean
5488|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 to 35 months, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Titers||95% Confidence Interval|Geometric Mean
5489|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available||Titers||95% Confidence Interval|Geometric Mean
5490|NCT02207413|Primary|Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
5491|NCT02207413|Primary|Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days)|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
5492|NCT02207413|Primary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses.|Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.||Subjects|||Number
5493|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to 17 years, with at least one vaccine administration documented.||Subjects|||Number
5494|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
5495|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) .|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
5496|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|"Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling.~Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination."|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
5497|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 5-17 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.||Days||Full Range|Median
5498|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 3-4 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.||Days||Full Range|Median
5499|NCT02207413|Primary|Duration of Solicited Local AEs in Subjects Aged 3-17 Years.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Days||Full Range|Median
5500|NCT02207413|Primary|Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
5501|NCT02207413|Primary|Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.||Subjects|||Number
5502|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. >50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.||Subjects|||Number
5503|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days following vaccination)|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~1 subject withdrew consent in the Influsplit Tetra_LP Adult Group and did not complete the study but was administered a study vaccine dose."||Subjects|||Number
5504|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
5505|NCT02207413|Primary|Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years.|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) post-vaccination period|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~N = Number of subjects with the symptom and without the missing confirmed grade"||Days||Full Range|Median
5506|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
5507|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.||Subjects|||Number
5508|NCT02207400|Secondary|Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks|Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).|Baseline, 6, 12, 24 and 32 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||colony forming units per sample||Standard Deviation|Mean
5509|NCT02207400|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.|The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
5510|NCT02207400|Secondary|Bleeding Index (BI) at 6, 12 and 24 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a Scale||Standard Deviation|Mean
5511|NCT02207400|Secondary|Modified Gingival Index (MGI)) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
5512|NCT02207400|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Baseline, 6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Number of bleeding sites||Standard Deviation|Mean
5513|NCT02207400|Primary|Modified Gingival Index (MGI) at 24 Weeks|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
5540|NCT02204748|Primary|Femoro-tibial Kinematics - Deep Knee Bend|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative|||degrees||Standard Deviation|Mean
5514|NCT02207400|Primary|Number of Gingival Bleeding Sites at 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.||Number of bleeding sites||Standard Deviation|Mean
5515|NCT02206607|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration in Period 4|The safety analysis population included all participants who received at least 1 dose of open-label, sponsor-provided metformin.||participants|||Number
5516|NCT02206607|Secondary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||hour||Standard Deviation|Mean
5517|NCT02206607|Secondary|Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
5518|NCT02206607|Secondary|Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||hours||Full Range|Median
5519|NCT02206607|Secondary|Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)|Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ratio||Geometric Coefficient of Variation|Geometric Mean
5520|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/dL||Geometric Coefficient of Variation|Geometric Mean
5521|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5522|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5523|NCT02206607|Secondary|Maximum Observed PF-04937319 Plasma Concentration (Cmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5524|NCT02206607|Primary|Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1|MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose|The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
5525|NCT02206607|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
5526|NCT02205814|Secondary|Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate|Response based on change ≥ 20 % from baseline for EQ-5D-5L index value|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT-population (n=431).||percentage of responders|||Number
6870|NCT02144220|Secondary|Percentage of Patients Who Felt That the Recommendations Improved Their Health||6 months|||percentage of participants|||Number
5527|NCT02205814|Secondary|Responder Rate According to OMERACT-OARSI Criteria|Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.|from baseline up to 6 weeks after randomisation|The secondary efficacy variables were analysed in the ITT population (n=431).||percentage of responders|||Number
5528|NCT02205814|Secondary|Change in WOMAC INDEX|The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT population (n=431).||units on a scale||Standard Deviation|Mean
5529|NCT02205814|Primary|Change in WOMAC A|The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.|from baseline up to 2 weeks after randomisation|The primary efficacy analysis was performed on the ITT-population (n=431).||units on a scale||Standard Deviation|Mean
5530|NCT02205476|Other Pre-specified|Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit|Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.|52 weeks after initial scar revision surgery in study B5301001|The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.|||||
5531|NCT02205476|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|||||
5532|NCT02205476|Primary|Part B: Number of Participants With Clinical Laboratory Abnormalities|Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|||||
5533|NCT02205476|Primary|Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|||||
5534|NCT02205476|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
5535|NCT02205476|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
5536|NCT02205476|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
5537|NCT02205476|Primary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.||units on scale||Standard Deviation|Mean
6871|NCT02144220|Secondary|Feasibility (Descriptive)|Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.|6 months|||percentage of visits|||Number
5541|NCT02204748|Secondary|Max Ground Reaction Force - Ramp Down|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative|||percentage of body weight||Standard Deviation|Mean
5542|NCT02204748|Secondary|Max Ground Reaction Force - Gait|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative|||percentage of body weight||Standard Deviation|Mean
5543|NCT02204748|Secondary|Max Ground Reaction Force - Deep Knee Bend|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative|||percentage of body weight||Standard Deviation|Mean
5544|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative|||mm||Standard Deviation|Mean
5545|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Gait|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative|||mm||Standard Deviation|Mean
5546|NCT02204748|Primary|Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative|||mm||Standard Deviation|Mean
5547|NCT02204657|Secondary|Hypoglycemia||28 weeks until delivery|||episodes per patient||Inter-Quartile Range|Median
5548|NCT02204657|Primary|Glycemic Control by Measurement of HbA1c||From 28 weeks until delivery|||mean percentage||Standard Deviation|Mean
5549|NCT02204579|Secondary|Change From Baseline in Fractional Excretion of Calcium (FECa) at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here n=number of participants analysed for specified category at the specified time points in each arm respectively.||Fraction of excretion||Standard Deviation|Mean
5550|NCT02204579|Secondary|Elimination Half-life (t1/2) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.||hour||Standard Deviation|Mean
5551|NCT02204579|Secondary|Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all randomized participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least one day of infusion.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
5552|NCT02204579|Secondary|Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.||nanogram*hour per milliliter(ng·h/mL)||Standard Deviation|Mean
5553|NCT02204579|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795||Baseline (Predose), and 15, 30 Minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment pharmacokinetic (PK) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.||nanogram*hour per millilitre (ng·h/mL)||Standard Deviation|Mean
5554|NCT02204579|Primary|Change From Baseline in Serum Parathyroid Hormone (PTH) at Specified Time Point||Baseline (Predose), 5.5 Hours, 8 Hours Postdose|Post amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||nanogram/liter (ng/L)||Standard Deviation|Mean
5555|NCT02204579|Primary|Change From Baseline in Urinary Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||millimole/liter (mmol/L)||Standard Deviation|Mean
5556|NCT02204579|Primary|Change From Baseline in Serum Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||millimole/liter (mmol/L)||Standard Deviation|Mean
5557|NCT02204579|Primary|Change From Baseline in Ionised Calcium at Specified Timepoint||Baseline (Predose), 4 Hours and 8 Hours Postdose|Post-amendment pharmacodynamic (PD) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.||millimole/liter (mmol/L)||Standard Deviation|Mean
6872|NCT02144220|Secondary|Acceptability|- The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal >80%)|6 months|||percentage of participants|||Number
5558|NCT02204579|Primary|Number of Participants With Clinically Significant Abnormalities Related to Physical Examination||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).||participants|||Number
5559|NCT02204579|Primary|Number of Participants With Potentially Clinically Important Laboratory Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).||participants|||Number
5560|NCT02204579|Primary|Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).||participants|||Number
5561|NCT02204579|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).||participants|||Number
5562|NCT02204449|Other Pre-specified|Cardiac Rehabilitation Enrollment in Site Closer to Home|A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.|8 weeks after patient is discharged from hospital|||participants|||Number
5563|NCT02204449|Secondary|Cardiac Rehabilitation Referral|A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.|12 weeks after patient has been discharged from hospital|||participants|||Number
5564|NCT02204449|Primary|Cardiac Rehabilitation Enrollment|A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.|12 weeks after patient is discharged from hospital|||participants|||Number
5565|NCT02203916|Secondary|Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6|Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
5566|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic SBP Response at Week 6|SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
5567|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic DBP Response at Week 6|Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
5568|NCT02203916|Secondary|Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)|The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
5569|NCT02203916|Primary|Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)|The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).||mmHg||Standard Error|Least Squares Mean
5570|NCT02203786|Secondary|Winnings on Slot Machine Upon Completion of Game|Credits|15-minutes|||credits||Standard Deviation|Mean
5571|NCT02203786|Secondary|Speed of Play on Slot Machine Game|Number of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager.|15-minutes|||individual spins/15-minutes||Standard Deviation|Mean
5572|NCT02203786|Secondary|Betting Behaviour in Laboratory-based Slot Machine Game|Risk taking was operationally defined as credits wagered per spin (mean computed for total spins)|1x per test session (total of 4 test sessions) for duration of the study: 4 weeks (1 session/week)|||credits/spin on slot machine||Standard Deviation|Mean
5573|NCT02203786|Secondary|Cognitive Task Performance|Response time to words (gambling, alcohol, positive affect, negative affect) as a percentage of neutral categorized words (parts of a building). This provides an index of the relative salience of stimuli from these four categories against a baseline of reaction to words with no clinical relevance or emotional valence. Smaller scores indicate faster relative response time to the test stimuli vs. neutral stimuli (i.e., greater salience)|At key points during testing: immediately after the slot machine, at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)|||percentage of neutral categorized words||Standard Deviation|Mean
5574|NCT02203786|Secondary|Diastolic Blood Pressure (DBP)|Measure changes from baseline, especially physiologic reactivity to the slot machine and amphetamine.|At key points in testing: immediately after the slot machine game (change from session baseline), and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)(change from session baseline).|||mm Hg||Standard Deviation|Mean
5575|NCT02203786|Primary|Subjective Reinforcement Self-report Scales|Self-reported Confidence to Refrain from Gambling (0 - 10) was assessed at test session baseline, before the slot machine and after the slot machine (Phase 1); and before amphetamine and at peak amphetamine (Phase 2). The maximum score (10) denotes complete confidence to refrain from gambling (i.e., NO urge or compulsion to gamble); the minimum score (0) denotes complete lack of confidence to refrain from gambling (i.e., overwhelming urge to gamble). Scores between 10 and 0 denote intermediate confidence to refrain from gambling with LOWER scores denoting less confidence to refrain from gambling -- i.e., GREATER urge or compulsive motivation to gamble. Scores shown are based on single item visual analogue ratings 0-10 from each participant at the specified time point. The mean (SD) of these single item ratings is presented for each sub-group.|At key points in testing: immediately after the slot machine game, and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration).|||units on a scale||Standard Deviation|Mean
5576|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|1 week|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval)."||rating of visual distortion symptoms||Standard Deviation|Mean
5577|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|Baseline|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion)."||rating of visual distortion symptoms||Standard Deviation|Mean
5578|NCT02203721|Primary|Uncorrected Intermediate Visual Acuity|Uncorrected Intermediate Visual Acuity at 6 months.|6 months|Intent to Treat population||LogMAR||Standard Error|Mean
5579|NCT02203721|Primary|Distance Corrected Intermediate Visual Acuity|FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.|At 6 months|Intent to Treat Population||LogMAR||Standard Error|Mean
5580|NCT02203162|Primary|Change in Cough Reflex Sensitivity (Log C5)|Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|Baseline, 15 minutes, and 24 hours post-exposure to e-cig.|||log C5||95% Confidence Interval|Mean
5581|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
5582|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
5607|NCT02201953|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
16565|NCT01854593|Secondary|Endolaser Photocoagulation|Number of intraoperative endolaser photocoagulation.|End of surgery.|||photocoagulation||Standard Deviation|Mean
5583|NCT02203149|Primary|Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to Study Week 12 in Part 2|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 12. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants|||Number
5584|NCT02203149|Primary|Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 16. Data for participants in Part 1 were analyzed and reported separately.||percentage of participants|||Number
5585|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
5586|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants||95% Confidence Interval|Number
5587|NCT02203149|Primary|Part 1: Percentage of Participants That Discontinued Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.|Up to Study Week 12 in Part 1|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants|||Number
5588|NCT02203149|Primary|Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).|Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.||percentage of participants|||Number
5608|NCT02201940|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
5609|NCT02201940|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
5589|NCT02203149|Primary|Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.|12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)|The primary efficacy analysis was assessed in all treatment-naïve participants randomized to the Part 2 Immediate Treatment Arm who received ≥1 dose of study treatment and had any follow-up efficacy measurement. No other arms were analyzed for this outcome measure.||percentage of participants||95% Confidence Interval|Number
5590|NCT02202538|Secondary|Borg Rating of Perceived Exertion (BRPE) for Walking Indoors|6: no exertion at all 7: extremely light 8 9: very light 10 11: light 12 13: somewhat hard 14 15: hard (heavy) 16 17: very hard 18 19: extremely hard 20: maximal exertion|8 weeks|||units on a scale||Standard Deviation|Mean
5591|NCT02202538|Secondary|Functional Independence Measure (FIM) Score for Walking Indoors|"7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance~1: total assistance~Reference: rehabmeasures.org"|8 weeks|||units on a scale||Standard Deviation|Mean
5592|NCT02202538|Secondary|Walking Index for Spinal Cord Injury (WISCI-II) Assessment|"0: unable~parallel bars, braces, help of 2 persons, less than 10m~parallel bars, braces, help of 2 persons, 10m~parallel bars, braces, help of 1 person, 10m~parallel bars, no braces, help of 1 person, 10m~parallel bars, braces, no help, 10m~walker, braces, help of 1 person, 10m 7:2 crutches, braces, help of 1 person, 10m~8:walker, no braces, help of 1 person, 10m 9:walker, braces, no help, 10m 10:1 cane/crutch, braces, help of 1 person, 10m 11:2 crutches, no braces, help of 1 person, 10m 12:2 crutches, braces, no help, 10m 13:walker, no braces/help, 10m 14:1 cane/crutch, no braces, help of 1 person, 10m 15:1 cane/crutch, braces, no help, 10m 16:2 crutches, no braces/help, 10m 17:no devices/braces, help of 1 person, 10m 18: no devices, braces, no help, 10m 19:1cane/crutch, no braces/help, 10m 20:no devices/braces/help, 10m~Reference: rehabmeasures.org"|8 weeks|||units on a scale||Standard Deviation|Mean
5593|NCT02202538|Primary|Percentage of Subjects That Could Don/Doff the Device Independently||8 weeks|||percentage|||Number
5594|NCT02202538|Primary|Average Time to Don/Doff Device||8 weeks|||minutes||Standard Deviation|Mean
5595|NCT02202538|Primary|Timed Up and Go (TUG) Test||8 weeks|||seconds||Standard Deviation|Mean
5596|NCT02202538|Primary|Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study||8 weeks|||meters/second||Standard Deviation|Mean
5597|NCT02202538|Primary|Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)||8 weeks|||percentage|||Number
5598|NCT02202252|Other Pre-specified|Length of Hospital Stay||Participants will be followed for the duration of hospital stay, an expected average of 5 days|||days||Full Range|Median
5599|NCT02202252|Secondary|Seroma Formation|Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..|Twenty-four hours after removal of the drains up to 4 weeks|||participants|||Number
5600|NCT02202252|Primary|Patient Comfort Scale|Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).|Postoperative 5 days|||units on a scale||Full Range|Median
5601|NCT02202135|Primary|Clinical Response at TOC|Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose.|7 to 20 days after last dose of study drug|Randomized||Participant|||Number
5602|NCT02201953|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
5603|NCT02201953|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
5604|NCT02201953|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
5605|NCT02201953|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
5606|NCT02201953|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
7312|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Insertion|Surveyed after insertion Pair #3 (2 hours). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).|2 hours insertion|||units on a scale||Standard Deviation|Mean
5611|NCT02201940|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
5612|NCT02201940|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
5613|NCT02201940|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
5614|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
5615|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
5616|NCT02201901|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
5617|NCT02201901|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
5618|NCT02201901|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
5619|NCT02201901|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
5620|NCT02201901|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks plus 30 days|Safety Analysis Set||percentage of participants|||Number
5621|NCT02201901|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|The Full Analysis Set (FAS): participants who were randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
5622|NCT02201784|Other Pre-specified|Pulse Rate, Mean Arterial Pressure, SpO2|Intragroup and intergroup variation compared|8 hours||||||
5623|NCT02201784|Secondary|Duration of Motor Block|Time when the Bromage score will be back to zero|8 hours|||minutes||Standard Deviation|Mean
5624|NCT02201784|Secondary|Onset of Motor Block to Bromage3|Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).|8 hours|||minutes||Standard Deviation|Mean
5625|NCT02201784|Secondary|Time to Maximum Cephalic Spread of Sensory Block||8 hours|||minutes||Standard Deviation|Mean
5626|NCT02201784|Secondary|Median Maximum Level of Sensory Blockade|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|8 hours||||||
5627|NCT02201784|Secondary|Onset of Sensory Block at T10|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|30 minutes|||minutes||Standard Deviation|Mean
5628|NCT02201784|Primary|Duration of Analgesia|Defined as time for first analgesic request by the patient|8 hours|||minutes||Standard Deviation|Mean
5629|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters|ECG change data was reported as qualitative results, as per change in planned analysis. It was categorized as: normal; abnormal, not clinically significant or abnormal, clinically significant.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
5630|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate||Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||bpm|||Number
5631|NCT02201524|Secondary|Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||degree celsius||Standard Deviation|Mean
5632|NCT02201524|Secondary|Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||respiration per minute (resp/min)||Standard Deviation|Mean
5633|NCT02201524|Secondary|Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||beats per minute (bpm)||Standard Deviation|Mean
5634|NCT02201524|Secondary|Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
5635|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values|HSV DNA samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
5636|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values|CMV samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
5637|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values|EBV samples were collected and changes from baseline were evaluated by the principal investigator (PI) for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in adverse event (AEs) or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
5638|NCT02201524|Secondary|Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Reference range for measurements is 0-0.5 mg/dL and lower limit of detection is less than (<) 0.015 mg/dL. Any value <0.015 mg/dL is imputed as 0.0075 mg/dL.|Baseline, Week 1, 2, 3, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||mg/dL||Standard Deviation|Mean
5639|NCT02201524|Secondary|Change From Baseline in Lipid Ratios at Week 2, 4 and 8|The ratio of LDL-C/HDL-C was reported.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||ratio||Standard Deviation|Mean
5640|NCT02201524|Secondary|Change From Baseline in Fasting Lipids at Week 2, 4 and 8|Participants were required to fast 9 hours prior to sampling for lipid profile which included following parameters: low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), cholesterol, triglycerides.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
5641|NCT02201524|Secondary|Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8|The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicating more severity. Participants with response of clear and almost clear were reported. 90 percent confidence intervals were calculated using clopper-pearson (exact) method.|Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
5647|NCT02201524|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 4|The modified intent to treat (mITT) analysis set included all randomized participants who received at least 1 dose of the randomized study drug (PF-04965842 or placebo). Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
5648|NCT02201446|Secondary|MIF||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed||ng/ml||Standard Deviation|Mean
5642|NCT02201524|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 90 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
5643|NCT02201524|Secondary|Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 75 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
5644|NCT02201524|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 50 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of participants||90% Confidence Interval|Number
5645|NCT02201524|Secondary|Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
5646|NCT02201524|Secondary|Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percent change||Standard Deviation|Mean
5649|NCT02201446|Secondary|IL-6||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed||pg/ml||Standard Deviation|Mean
5650|NCT02201446|Secondary|TNF-α||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed||pg/ml||Standard Deviation|Mean
5651|NCT02201446|Secondary|Death||up to 28 days|||participants|||Number
5652|NCT02201446|Secondary|Days of Unassisted Ventilation||1 year|||days||Inter-Quartile Range|Mean
5653|NCT02201446|Secondary|Length of Hospital Stay||1 year|||days||Inter-Quartile Range|Mean
5654|NCT02201446|Secondary|Length of Stay in the ICU||1 year|not collected for healthy volunteers||days||Inter-Quartile Range|Mean
9190|NCT02063230|Primary|Dose Normalized Cmax, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
5655|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed.||ng/ml||Standard Deviation|Mean
5656|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 1|||ng/ml||Standard Deviation|Mean
5657|NCT02201446|Primary|Acute Physiology and Chronic Health Evaluation (APACHE) II Scores|APACHE II scores range from 0 to 71. A higher values represent a worse outcome.|up to 28 days|not collected for healthy volunteers||Scores on a scale||Standard Deviation|Mean
5658|NCT02201446|Primary|Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)||up to 28 days|not collected for healthy volunteers||ratio||Standard Deviation|Mean
5659|NCT02201446|Primary|Number of Participants Receiving Mechanical Ventilation||up to 28 days|not collected for healthy volunteers||participants|||Number
5660|NCT02201420|Secondary|Time to Localization|Number of Participants with Localization at One Hour|1 hour|||participants localizing in 1 hour|||Number
5661|NCT02201420|Primary|Localization|Count of subjects with a localization by Tc 99m tilmanocept by imaging. Localization is based on the use of SPECT imaging and defined as the accumulation of radioactivity at intensity greater than background.|Up to 4 days|||participants|||Number
5662|NCT02201056|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||ng*hr/mL||Standard Deviation|Mean
5663|NCT02201056|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||ng*hr/mL||Standard Deviation|Mean
5664|NCT02201056|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.||ng/mL||Standard Deviation|Mean
5665|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
5666|NCT02201056|Primary|Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
5667|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
5668|NCT02201056|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.|Day 1 to Day 30|Safety set included all participants who were enrolled and received study drug.||percentage of participants|||Number
5669|NCT02200536|Secondary|Change in Mother's Reported Bottle-feeding Practice.|Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.|Baseline (T0) and after one month (T1)|||percentage of mothers|||Number
5670|NCT02200536|Primary|Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.|Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.|Baseline (T0) and after one month (T1)|||percentage of mothers|||Number
5671|NCT02200458|Primary|Number of Participants for Whom Successful Visualization of Vasculature Was Achieved||One day|||participants|||Number
5672|NCT02200328|Secondary|Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.|||||
5673|NCT02200328|Primary|The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.|||||
5719|NCT02197234|Primary|Cmax of Simvastatin|Pharmacokinetics of simvastatin by assessment of maximum plasma simvastatin concentration|Blood samples are collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng/mL||Full Range|Geometric Mean
5674|NCT02199717|Primary|Sedentary Time|To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.||minutes per day||Standard Deviation|Mean
5675|NCT02199717|Primary|MVPA|To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.||minutes per day||Standard Deviation|Mean
5676|NCT02199574|Primary|The Apparent Terminal Elimination Rate Constant (λz)||From time of study drug administration through Day 7 postdose|||1/hours||Standard Deviation|Mean
5677|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))||From time of study drug administration through Day 7 postdose|||hours*ng/mL||Standard Deviation|Mean
5678|NCT02199574|Primary|Apparent Terminal Elimination Half-life||From time of study drug administration through Day 7 postdose|||hours||Standard Deviation|Mean
5679|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))||From time of study drug administration through Day 7 postdose|||hours*ng/mL||Standard Deviation|Mean
5680|NCT02199574|Primary|Time to Maximum Plasma Concentration (Tmax)||From time of study drug administration through Day 7 postdose|||hours||Full Range|Median
5681|NCT02199574|Primary|Maximum Plasma Concentration (Cmax)||From time of study drug administration through Day 7 postdose|||ng/mL||Standard Deviation|Mean
5682|NCT02198963|Primary|Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin|"Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.~Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study."|21 days|Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites||units on a scale||Standard Deviation|Mean
5683|NCT02198430|Secondary|Measure of Weight|Measure of weight|Screening visit (pretreatment assessment)|||Kg||Standard Deviation|Mean
5684|NCT02198430|Secondary|Assessment of Clinical Patient Variables|Hemophilia type measuring (A or B)|Screening visit|||Percentage of Participants with Hemophil|||Number
5685|NCT02198430|Primary|Assess the Perception of Quality of Life|Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).|Screening visit|The score ranges from 0 (poor QoL) to 100 points (good perception of QoL).||points||Standard Deviation|Mean
5686|NCT02198430|Primary|Assess the Joint Damage|Measurement with Haemophilia Joint Health Score 2.1 (HJHS)|Screening visit|Haemophilia Joint Health Score assesses joint health in patients with hemophilia. It consists of eight dimensions: swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. The higher the score, the higher).||points||Standard Deviation|Mean
5687|NCT02198235|Secondary|Median Time to Requiring Oral Opioids|Did patient have pain requiring oral opioids?|24 hours after the popliteal block is given|||hours||95% Confidence Interval|Median
5688|NCT02198235|Secondary|Numeric Rating Scale (NRS) Pain Score at Rest|Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given|||units on a scale||Standard Error|Mean
5689|NCT02198235|Secondary|Block Duration|When did the nerve block entirely wear off?|24 hours and 48 hours after the popliteal block is given|||hours||95% Confidence Interval|Median
5690|NCT02198235|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given|||units on a scale||Standard Deviation|Mean
5691|NCT02197806|Primary|Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye|UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.|Baseline, Day 3|Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA||Percentage of Patients|||Number
5692|NCT02197273|Secondary|Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days||Date of discharge through 30 days following discharge|||participants|||Number
5693|NCT02197273|Secondary|Time to Post-operative Rescue Opioids (Hours)||Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days|||hours||Full Range|Median
5694|NCT02197273|Primary|Length of Stay in Hospital (Days)||Participants were followed for the duration of hospital stay, an expected average of 3 days|||days||Full Range|Median
5720|NCT02196766|Primary|Ocular Health - Papillary Conjunctivitis|Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
5721|NCT02196766|Primary|Ocular Health - Limbal Redness|Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
5695|NCT02197247|Secondary|Assessment of the Metabolic Ratios of AUCtau for AZ5104 and AZ7550 (MRAUCtau)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for AUCtau (MRAUCtau). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
5696|NCT02197247|Secondary|Assessment of the Metabolic Ratios of Css,Max for AZ5104 and AZ7550 (MRCss,Max)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for Css,max (MRCss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||Ratio||Geometric Coefficient of Variation|Geometric Mean
5697|NCT02197247|Secondary|Assessment of CLss/F for Rifampicin|Rate and extent of absorption of rifampicin by assessment of CLss/F. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|||L/h||Geometric Coefficient of Variation|Geometric Mean
5698|NCT02197247|Secondary|Assessment of CLss/F for AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apparent plasma clearance following oral administration and multiple dosing (CLss/F). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|||Litre per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
5699|NCT02197247|Secondary|Assessment of Css,Min for Rifampicin|Rate and extent of absorption of rifampicin by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5700|NCT02197247|Secondary|Assessment of Css,Min for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
5701|NCT02197247|Secondary|Assessment of Tss,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of tss,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
5702|NCT02197247|Secondary|Assessment of Tss,Max for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of time to reach maximum plasma concentration at steady state (tss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||h||Full Range|Median
5703|NCT02197247|Secondary|Assessment of AUCtau for Rifampicin|Rate and extent of absorption of rifampicin by assessment of AUCtau. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5704|NCT02197247|Secondary|Assessment of AUCtau for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM*h||Geometric Coefficient of Variation|Geometric Mean
5705|NCT02197247|Secondary|Assessment of AUCtau for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM*h||Geometric Coefficient of Variation|Geometric Mean
5706|NCT02197247|Secondary|Assessment of AUCtau for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM*h||Geometric Coefficient of Variation|Geometric Mean
5707|NCT02197247|Secondary|Assessment of Css,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of Css,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
5708|NCT02197247|Secondary|Assessment of Css,Max for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
5709|NCT02197247|Secondary|Assessment of Css,Max for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
5710|NCT02197247|Secondary|Assessment of Css,Max for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of Css,max. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM||Geometric Coefficient of Variation|Geometric Mean
5711|NCT02197247|Primary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval for AZD9291 After Dosing Alone and in Combination With Rifampicin (AUCtau)|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 following AZD9291 and rifampicin at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nM * hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
5712|NCT02197247|Primary|Assessment of Maximum Plasma Concentration for AZD9291 After Dosing Alone and in Combination With Rifampicin (Css,Max)|Rate and extent of absorption of AZD9291 by assessment of maximum plasma concentration at steady state (Css,max). AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
5713|NCT02197234|Secondary|AUC(0-t) of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by assessment of area under the plasma concentration time curve from time zero to last quantifiable dose|Blood samples are collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng.h/mL||Full Range|Geometric Mean
5714|NCT02197234|Secondary|AUC of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples are collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng.h/mL||Full Range|Geometric Mean
5715|NCT02197234|Secondary|Cmax of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of maximum plasma simvastatin acid concentration|Blood samples are collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng/mL||Full Range|Geometric Mean
5716|NCT02197234|Secondary|CL/F of Simvastatin|Rate and extent of absorption of simvastatin by assessment of apparent clearance following oral administration|Blood samples are collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||L/h||Full Range|Geometric Mean
5717|NCT02197234|Secondary|Tmax of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by time to Cmax|Blood samples are collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||hours||Full Range|Median
5718|NCT02197234|Primary|AUC of Simvastatin|Pharmacokinetics of simvastatin by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples are collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.||ng.h/mL||Full Range|Geometric Mean
5722|NCT02196766|Primary|Ocular Health - Conjunctival Redness|Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
5723|NCT02196766|Secondary|Burning Sensation Right After Insertion (Subjective Rating)|Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline|||units on a scale||Standard Deviation|Mean
5724|NCT02196766|Secondary|Stinging Sensation Right After Insertion (Subjective Rating)|Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline|||units on a scale||Standard Deviation|Mean
5725|NCT02196766|Primary|Ocular Health - Corneal Staining|Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week|||Eyes|Participants||Number
5726|NCT02196675|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||days||Standard Deviation|Mean
5727|NCT02196675|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||milliliters||Standard Deviation|Mean
5728|NCT02196675|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.||days||Standard Deviation|Mean
5729|NCT02196675|Secondary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|ll subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
5730|NCT02196675|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
5731|NCT02195713|Primary|Urine Output of SOC Device Versus Accuryn|Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.|2 - 5 days|||Patients with airlocks||95% Confidence Interval|Number
5732|NCT02195687|Secondary|Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
5733|NCT02195687|Secondary|Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire|Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.|Baseline, Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline||Percentage of Subjects|||Number
5734|NCT02195687|Secondary|Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)|Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
5735|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
5736|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
5737|NCT02195687|Primary|Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug||Percentage of Subjects|||Number
5738|NCT02195583|Secondary|Percentage Comparative Acid Resistance (% CAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||Percentage of CAR||Standard Error|Least Squares Mean
5739|NCT02195583|Secondary|Percentage Net Acid Resistance (% NAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||Percentage of NAR||Standard Error|Least Squares Mean
5740|NCT02195583|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||microgram per square centimeter(μg/cm^2)||Standard Error|Least Squares Mean
5741|NCT02195583|Primary|Percentage Surface Microhardness Recovery (% SMHR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.|Baseline to 4 hours|The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.||Percentage of SMHR||Standard Error|Least Squares Mean
5742|NCT02195414|Secondary|MSCT Endpoint||3 years||10/2018||||
5743|NCT02195414|Secondary|MSCT Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|1 year||10/2016||||
5744|NCT02195414|Secondary|IVUS Endpoint||5 years||10/2020||||
5745|NCT02195414|Secondary|IVUS Endpoint||2 years||10/2017||||
5746|NCT02195414|Secondary|IVUS Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|6 months||04/2016||||
5747|NCT02195414|Secondary|OCT Endpoint||5 years||10/2020||||
5748|NCT02195414|Secondary|OCT Endpoint||2 years||10/2017||||
5749|NCT02195414|Secondary|OCT Endpoint|proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.|6 months||04/2016||||
5750|NCT02195414|Secondary|Angiographic Endpoint||5 years||10/2020||||
5751|NCT02195414|Secondary|Angiographic Endpoint||2 years||10/2016||||
5752|NCT02195414|Secondary|Angiographic Endpoint|In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).|6 months||04/2016||||
5753|NCT02195414|Secondary|Scaffold Thrombosis||5 years||10/2020||||
5754|NCT02195414|Secondary|Scaffold Thrombosis||4 years||10/2019||||
5755|NCT02195414|Secondary|Scaffold Thrombosis||3 years||10/2018||||
5756|NCT02195414|Secondary|Scaffold Thrombosis||2 years||10/2017||||
5757|NCT02195414|Secondary|Scaffold Thrombosis||1 year||10/2016||||
5758|NCT02195414|Secondary|Scaffold Thrombosis||6 months||04/2016||||
5759|NCT02195414|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤1day), subacute (>1day ≤30 days) and late (>30 days).~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days."|30days|||participants|||Number
5783|NCT02193828|Secondary|Percent Change From Baseline in Hardness of the Treated Nodule at Day 57|A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.||percentage of change||Standard Deviation|Mean
20573|NCT01763905|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
5760|NCT02195414|Secondary|Acute Success (Clinical Device and Clinical Procedure)|"Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).~Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success."|acute|||participants|||Number
5761|NCT02195414|Secondary|Patient Oriented Composite Endpoint||5 years||10/2019||||
5762|NCT02195414|Secondary|Patient Oriented Composite Endpoint||4 years||10/2018||||
5763|NCT02195414|Secondary|Patient Oriented Composite Endpoint||3 years||10/2017||||
5764|NCT02195414|Secondary|Patient Oriented Composite Endpoint||2 years||10/2016||||
5765|NCT02195414|Secondary|Patient Oriented Composite Endpoint||1 year||10/2016||||
5766|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|6 months||04/2016||||
5767|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|30 days|||participants|||Number
5768|NCT02195414|Secondary|Target Lesion Failure||5 years||10/2020||||
5769|NCT02195414|Secondary|Target Lesion Failure||4 years||10/2019||||
5770|NCT02195414|Secondary|Target Lesion Failure||3 years||10/2018||||
5771|NCT02195414|Secondary|Target Lesion Failure||2 years||10/2017||||
5772|NCT02195414|Secondary|Target Lesion Failure||1 year||10/2016||||
5773|NCT02195414|Secondary|Target Lesion Failure|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|6 months||04/2016||||
5774|NCT02195414|Primary|Target Lesion Failure(TLF)|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|30 days|||participants|||Number
5775|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|12 hours|||colony forming units||Standard Error|Mean
5776|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|Baseline|||colony forming units||Standard Deviation|Mean
5777|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|12 hours|||colony forming units||Standard Error|Mean
5778|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|Baseline|||colony forming units||Standard Deviation|Mean
5779|NCT02193828|Secondary|Composite Responder Analysis|A composite responder is a subject who had an improved assessment [values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)] on the investigator global assessment and had a satisfied assessment [values of 1 (very satisfied) or 2 (quite satisfied)] on the subject assessment.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.||participants|||Number
5780|NCT02193828|Secondary|Subject Satisfaction With Treatment|Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.||units on a scale||Standard Deviation|Mean
5781|NCT02193828|Secondary|Investigator Global Assessment of Improvement With Treatment|Investigators were asked to determine the degree of improvement in the subject’s treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.||units on a scale||Standard Deviation|Mean
5782|NCT02193828|Secondary|Change From Baseline in Nodular Pain of the Treated Nodule at Day 57|After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.||units on a scale||Standard Deviation|Mean
5794|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
5784|NCT02193828|Secondary|Change From Baseline in Consistency of the Treated Nodules at Day 57|Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.||units on a scale||Standard Deviation|Mean
5785|NCT02193828|Secondary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound|Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.||percentage of change||Standard Deviation|Mean
5786|NCT02193828|Primary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements|Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on Modified Intent-to-Treat (mITT) population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.||percentage of change||Standard Deviation|Mean
5787|NCT02193815|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg.|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.||participants|||Number
5788|NCT02193815|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.||participants|||Number
5789|NCT02193815|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.|Baseline up to 28 days after last study drug administration (Day 21)|The safety population included all enrolled participants who received at least 1 dose of investigational product.||participants|||Number
5790|NCT02193815|Secondary|Global Clinical Assessment at Day 1, 8 and 12|"Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as 0 (unchanged)."|Day 1, Day 8, Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||participants|||Number
5791|NCT02193815|Secondary|Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB|The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.|Day 1 (baseline) up to Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers*day||Standard Deviation|Mean
5792|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8||Day 1 (Baseline), Day 8|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
5793|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
6930|NCT02142153|Secondary|Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities|Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit|Single dose|||participants|||Number
5795|NCT02193815|Primary|Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12|Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.|Day 1 (Baseline), Day 12|The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.||micrometers||Standard Deviation|Mean
5796|NCT02193178|Primary|Investigator Acceptability|Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.|Baseline and 2 weeks|||percentage of subjects|||Number
5797|NCT02193178|Primary|Overall Preference|Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|||percentage of subjects|||Number
5798|NCT02193178|Primary|Preference - Handling|Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|Missing data for handling preference for one participant.||percentage of subjects|||Number
5799|NCT02193178|Primary|Preference - Vision|Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|||percentage of subjects|||Number
5800|NCT02193178|Primary|Subjective Preference - Comfort|Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|||percentage of subjects|||Number
5801|NCT02193178|Primary|Visual Acuity|Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||LogMAR||Standard Deviation|Mean
5802|NCT02193178|Primary|Anterior Ocular Health - Conjunctival Staining and Indentation|Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
5803|NCT02193178|Primary|Anterior Ocular Health - Corneal Staining|Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
5804|NCT02193178|Primary|Anterior Ocular Health - Bulbar and Limbal Redness|Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
5805|NCT02193178|Primary|Anterior Ocular Health - Palpebral Hyperemia and Roughness|Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks|||units on a scale|eyes|Standard Deviation|Mean
5806|NCT02193178|Primary|Lens Fit Acceptance|General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.||units on a scale|eyes|Standard Deviation|Mean
5807|NCT02193178|Primary|Lens Fit - Overall Stability|Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.||units on a scale|eyes|Standard Deviation|Mean
5808|NCT02193178|Primary|Lens Fit - Rotation|Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.||percentage of eyes|eyes||Number
5809|NCT02193178|Primary|Overall Satisfaction|Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
5810|NCT02193178|Primary|Handling|Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
5811|NCT02193178|Primary|Overall Vision|Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.|2 weeks prior to baseline, Baseline, 2 weeks post|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
5812|NCT02193178|Primary|Overall Comfort|Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.||units on a scale||Standard Deviation|Mean
5813|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks|||units on a scale||Standard Deviation|Mean
5814|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks|||units on a scale||Standard Deviation|Mean
5815|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline|||units on a scale||Standard Deviation|Mean
5816|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||units on a scale||Standard Deviation|Mean
5817|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks|||units on a scale||Standard Deviation|Mean
5818|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline|||units on a scale||Standard Deviation|Mean
5819|NCT02193087|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set|Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.|Days 8, 15, 91, 97 and 104|"The Safety Laboratory Sub-Set included randomly chosen participants from each treatment group for whom samples for clinical safety lab tests were collected and who received at least one vaccination dose. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
5820|NCT02193087|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Up to 6 Months after the last dose (9 months)|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
5821|NCT02193087|Secondary|Percentage of Participants With Any Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|Up to Day 28 after each vaccination|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
5822|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity|The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
5823|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity|The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.||percentage of participants|||Number
5824|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs)|Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
5839|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
6931|NCT02142153|Primary|Number of Subjects With Adverse Events|Adverse events will be collected from the time of screening until the final study visit|Single dose|Full analytical set||participants|||Number
5825|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)|Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the Safety Set (SS) with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.||percentage of participants|||Number
5826|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Months 1 and 4|PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. “n” in each of the categories is the number of participants with data available at the given time-point.||percentage of participants||95% Confidence Interval|Number
5827|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1, and have no major protocol violations. Participants seropositive at Baseline are not included.||percentage of participants||95% Confidence Interval|Number
5828|NCT02193087|Secondary|Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B|Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.|Months 1 and 4|"PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. n in each of the categories is the number of participants with data available at the given time-point."||titer||90% Confidence Interval|Least Squares Mean
5829|NCT02193087|Primary|Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined|"Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.~A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis."|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included.||titer||90% Confidence Interval|Least Squares Mean
5830|NCT02192879|Other Pre-specified|Serious Adverse Events Associated With Regional Catheter Placement|Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored|postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days|only patients who had a catheter||serious adverse events|||Number
5831|NCT02192879|Secondary|Highest VAS Pain Scores With Coughing|Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days|||units on a scale||Standard Deviation|Mean
5832|NCT02192879|Secondary|Incidence of Major Postoperative Complication|Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise|||complications|||Number
5833|NCT02192879|Secondary|Cumulative Postoperative Opioid Requirement|Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.|postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days|||mg||Standard Deviation|Mean
5834|NCT02192879|Secondary|Gastrointestinal Recovery|Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.|postoperatively until return of bowel function, up to 7 days|||days||Standard Deviation|Mean
5835|NCT02192879|Secondary|Hospital Length of Stay|Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise|||days||Standard Deviation|Mean
5836|NCT02192879|Primary|Highest VAS Pain Score at Rest|Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days|||units on a scale||Standard Deviation|Mean
5837|NCT02192814|Other Pre-specified|The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5|No descriptive statistics have been calculated for this exploratory Outcome Measure.|From Day -1 to Day 5||||||
5838|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
5840|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
5841|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
5842|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
5843|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
5844|NCT02192814|Primary|The Total Number of Subject Withdrawal Due to Adverse Events During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||participants|||Number
5845|NCT02192814|Primary|The Total Number of Subjects Experiencing at Least One Adverse Event During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.||participants|||Number
5846|NCT02191865|Secondary|Number (%) of Subjects With Drug-related Adverse Events (AEs)|Number (%) of subjects with drug-related Adverse events (AEs)|(AEs) during the 'on-treatment' period (from administration of trial medication until the end of the 28-day residual effect period); Up to 29 days|TS||percentage of participants|||Number
5847|NCT02191865|Secondary|AUC (0-tz) of Nintedanib|AUC (0-tz) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5848|NCT02191865|Primary|Cmax of Nintedanib|Cmax (Maximum measured concentration of the Nintedanib in plasma)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5849|NCT02191865|Primary|AUC (0-inf) of Nintedanib|AUC (0-inf) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 extrapolated to infinity)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5850|NCT02191046|Secondary|the Contamination in Nasal Irrigation Devices|compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism|at second week after treatment||||||
5851|NCT02191046|Primary|the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children|For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment|compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment|The S5- score is the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).||units on a scale||Standard Deviation|Mean
5852|NCT02190591|Other Pre-specified|Third and Fourth Degree Lacerations|Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery|within the last 15-30 minutes of birth|participants with vaginal delivery only||3rd or 4th degree lacerations|||Number
5853|NCT02190591|Secondary|Dilation to Second Stage Labor|Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation|thirty minutes after epidural given to birth of baby|Included participants with vaginal delivery only||minutes||Standard Deviation|Mean
5854|NCT02190591|Primary|Delivery Rate|Rate of patients who deliver by cesarean section|.5-72 hours|||participants|||Number
5891|NCT02189122|Primary|Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
5855|NCT02189954|Secondary|Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour|The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour|Postoperative 24.hour|Chi Square Test for categorical variables, for constant variables t test when suitable for normal distribution and when unsuitable for normal distrubition Mann Whitney U have been used for analysis. p < 0.05 was considered significant.||units on a scale||Full Range|Median
5856|NCT02189954|Primary|Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour|The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour|Postoperative 1.hour|||units on a scale||Full Range|Median
5857|NCT02189941|Secondary|Safety and Tolerability of Deferiprone Sustained Release Tablets|The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests|From time of dose until 24 hours post dose|All subjects who received at least one dose of study medication and had at least one safety assessment||participants|||Number
5858|NCT02189941|Primary|Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide|Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||h||Standard Deviation|Mean
5859|NCT02189941|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||h||Standard Deviation|Mean
5860|NCT02189941|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||mcg/mL||Standard Deviation|Mean
5861|NCT02189941|Primary|AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||mcg*h/mL||Standard Deviation|Mean
5862|NCT02189941|Primary|AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data||mcg*h/mL||Standard Deviation|Mean
5863|NCT02189915|Secondary|Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy|Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless.|8 weeks|||Phosphocreatine levels (unitless)||Standard Deviation|Mean
5864|NCT02189915|Primary|Depression Rating Scores|Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.|8-week|||units on a scale||Standard Deviation|Mean
5865|NCT02189863|Secondary|Standard Deviation of Lateral Positioning|The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).||meters||Standard Deviation|Mean
5866|NCT02189863|Primary|Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)|Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).||seconds||Standard Deviation|Mean
5867|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein(a) Production Rate||Baseline and Day 50||03/2017||||
5868|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein(a) Fractional Catabolic Rate (FCR)||Baseline and Day 50||03/2017||||
5869|NCT02189837|Secondary|Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)|The production rate of apolipoprotein B-100 in LDL was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate the production rate.|Baseline and Day 50|Efficacy Analysis Set||percent change||Standard Error|Least Squares Mean
5870|NCT02189837|Secondary|Percent Change From Baseline in LDL-C at Day 50|LDL-C was measured using ultrcentrifugation.|Baseline and Day 50|Efficacy Analysis Set with available data at both time points||percent change||Standard Error|Least Squares Mean
5892|NCT02188849|Other Pre-specified|Serum Creatinine|Serum creatinine levels|Twelve weeks|||mg/dl||Standard Deviation|Mean
5871|NCT02189837|Primary|Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR)|The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particiles were isolated from plasma by sequential ultracentrifugation and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.|Efficacy Analysis Set including all randomized and dosed participants who completed baseline and Day 50 measurements.||percent change||Standard Error|Least Squares Mean
5872|NCT02189317|Secondary|Difference in Time to First Opioid Use|The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."||hours||Standard Deviation|Mean
5873|NCT02189317|Secondary|Change in Home Opioid Use|The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."||miligrams||Standard Deviation|Mean
5874|NCT02189317|Primary|Change in Numerical Rating Scale (NRS) Pain Score|The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to “no pain” and ten is equal to “worst possible” pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."||units on a scale||Standard Deviation|Mean
5875|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||ug/mL||Geometric Coefficient of Variation|Geometric Mean
5876|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
5877|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DHA||This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.|PK Population||ug/mL||Geometric Coefficient of Variation|Geometric Mean
5878|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DHA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
5879|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||ug/mL||Geometric Coefficient of Variation|Geometric Mean
5880|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
5881|NCT02189252|Primary|Baseline-adjusted Cmax for Plasma Total EPA + Total DHA|Cmax: Maximum measured plasma concentration over the time span specified|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
5882|NCT02189252|Primary|Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA|AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population||hr*nmol/mL||Geometric Coefficient of Variation|Geometric Mean
5883|NCT02189161|Secondary|Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition|Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)|0-2 weeks Prior RFA and after 9-12 months post RFA|||units on a scale||Full Range|Median
5884|NCT02189161|Secondary|Subject Tolerability: Post -Ablation Anal Pain|Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)|within 4 weeks post RFA|||units on a scale||Full Range|Median
5885|NCT02189161|Primary|Related Adverse Events|Adverse event : Device relationship - Definite, Probable, Possible|Within 12 months post RFA|||number of participants|||Number
5886|NCT02189122|Primary|Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection|Data are given for 162.5 mg study day||ng/mg creatinine||Inter-Quartile Range|Median
5887|NCT02189122|Primary|Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
5888|NCT02189122|Primary|Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
5889|NCT02189122|Primary|Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
5890|NCT02189122|Primary|Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose||24 hour collection|||ng/mg creatinine||Inter-Quartile Range|Median
5896|NCT02188589|Secondary|Secondary Efficacy Endpoint|"Degree of nasal patency assessed by validated NOSE (Nasal Obstruction Symptom Evaluation) Questionnaire (Stewart, et al., “Development and Validation of the Nasal Obstruction Septoplasty Effectiveness (NOSE) Scale,” Otolaryngology - Head and Neck Surgery, Volume 130, Issue 2, February 2004, pp. 157-163.) The NOSE score uses a 0 to 20-point scale to capture severity of breathing symptoms, with higher scores indicating more severe symptoms than lower scores."|6 months|||percent change from baseline||95% Confidence Interval|Least Squares Mean
5897|NCT02188589|Primary|Implant Related Adverse Events|Implant related adverse events|6 months|||implant related adverse events|Participants||Number
5898|NCT02187809|Secondary|Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.|||||
5899|NCT02187809|Secondary|Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.|||||
5900|NCT02187809|Secondary|Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures||Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.|||||
5901|NCT02187809|Primary|Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.|||||
5902|NCT02187809|Primary|Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years||Baseline and from Day 0 to Day 360|At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.|||||
5903|NCT02187809|Primary|Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study||participants|||Number
5904|NCT02187809|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.||participants|||Number
5905|NCT02187029|Secondary|Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg||Standard Deviation|Mean
5906|NCT02187029|Secondary|Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary xanthine cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg||Standard Deviation|Mean
5907|NCT02187029|Secondary|Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary uric acid cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg||Standard Deviation|Mean
5908|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up||Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mcg/mL||Standard Deviation|Mean
5909|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up|Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.|Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
5910|NCT02187029|Secondary|Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14|PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).|Day 1, Day 7, and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||ng/mL||Standard Deviation|Mean
5911|NCT02187029|Secondary|Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14|Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).|0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14|All participants randomized and treated who have at least 1 measureable concentration; n=number of participants analyzed in each respective arm.||ng/mL||Standard Deviation|Mean
5912|NCT02187029|Secondary|Duration of Gout Flare Attacks|Duration of gout flare attacks with participants who developed gout flare attacks.|Baseline up to Day 42|Participants who developed gout flare attacks (Duration was not assessed as no participant developed gout flare attacks).|||||
5913|NCT02187029|Secondary|Incidence and Severity of Gout Flare Attacks||Baseline up to Day 42|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.||participants|||Number
5914|NCT02187029|Secondary|Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14|Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation.|24 hours post dose on Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.||participants|||Number
5915|NCT02187029|Secondary|Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up||Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.||mg/dL||Standard Deviation|Mean
5916|NCT02187029|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to < 480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec from baseline.|Baseline up to Day 16|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
5917|NCT02187029|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
5918|NCT02187029|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
5919|NCT02187029|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events.|Baseline up to 28 days after last study drug administration (Day 42)|The safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
5920|NCT02187029|Primary|Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14||Day 14 Hour 24|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to “Cohort 2: PF-06743649 5 mg” termination after 2 days of dosing.||percent (%)||Standard Deviation|Mean
5921|NCT02187029|Primary|Baseline of Serum Uric Acid|An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.|Baseline (pre-dose Day 1)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.||milligram per deciliter(mg/dL)||Standard Deviation|Mean
5922|NCT02187016|Secondary|Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|28 days|||units on a scale||Standard Error|Least Squares Mean
5923|NCT02187016|Secondary|Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|14 days|||units on a scale||Standard Error|Least Squares Mean
5924|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|28 days|||units on a scale||Standard Error|Least Squares Mean
5925|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|14 days|||units on a scale||Standard Error|Least Squares Mean
5926|NCT02187016|Secondary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28|MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).|28 days|||units on a scale||Standard Error|Least Squares Mean
5927|NCT02187016|Primary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14|MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).|14 days|||units on a scale||Standard Error|Least Squares Mean
5928|NCT02186808|Secondary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.|prosthesis delivery, 5 years|5 year data. Not all initially treated patients could be followed over the 5 years.||percentage of successful implants|Participants||Number
21688|NCT01738971|Other Pre-specified|Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties||12 months||||||
5929|NCT02186808|Primary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.|prosthesis delivery, 1 year|78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.||percentage of successful implants|Participants||Number
5930|NCT02186587|Primary|Distance Measured During 6-minute Walk Test|Subjects will walk for 6 minutes and the distance covered will be measured in feet.|6 months|||feet||Standard Deviation|Mean
5931|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 24 hour diameter)/24 hour diameter × 100.|24 hours after infusion|||percentage of brachial artery diameter||Standard Error|Mean
5932|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 4 hour diameter)/4 hour diameter × 100.|4 hours after infusion|||percentage of brachial artery diameter||Standard Error|Mean
5933|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline|||percentage of brachial artery diameter||Standard Error|Mean
5934|NCT02185534|Secondary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))|Comparison of the pharmacokinetic profile in terms of the area under the plasma concentration-curve from time zero to the time of last quantifiable clopidogrel or SR26334 concentration, AUC(0-last), of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
5935|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)|Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5936|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))|Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of clopidogrel sourced in Europe and Japan.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US). AUC(0-inf) could not be reliably calculated for many of these subjects.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5937|NCT02185339|Other Pre-specified|Postoperative Pain|"Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by “no pain” (score of 0) and “pain as bad as it could be” (score of 10).~Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h."|Postoperative 2 days|||Scores on a scale||Standard Deviation|Mean
5938|NCT02185339|Other Pre-specified|Surgical Condition|Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)|At completion of pneumoperitoneum surgery|||Participants|||Number
5939|NCT02185339|Other Pre-specified|Cardiac Index|"Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative|||L/min/m^2||Standard Deviation|Mean
5940|NCT02185339|Other Pre-specified|Stroke Volume Variation|"Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative|||% of mean stroke volume||Standard Deviation|Mean
5941|NCT02185339|Secondary|Pulmonary Shunt|"Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative|||% of shunt||Standard Deviation|Mean
5942|NCT02185339|Secondary|Estimated Dead Space|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative|||% of respiratory dead space||Standard Deviation|Mean
5943|NCT02185339|Secondary|Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative|||mmHg||Standard Deviation|Mean
5944|NCT02185339|Secondary|Arterial Oxygen Tension/Inspired Oxygen Fraction|Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative|||mmHg||Standard Deviation|Mean
6051|NCT02179398|Primary|Antibiotic Prescription Rate||at PED (Pediatric Emergency Department) presentation|children 7 days – 36 months old presenting to the PED with fever without source (FWS) ≥38.0°C (≥ 100.4°F) after a thorough history and careful examination||participants|||Number
5945|NCT02185339|Primary|Thoracopulmonary Compliance|"Was measured with a patient spirometry monitor through a flow sensor.~Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP)."|intraoperative|||ml/cmH2O||Standard Deviation|Mean
5946|NCT02185183|Primary|Number of Participants With Improved in Disease Activity||15 weeks|||participants|||Number
5947|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Inferior)|Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
5948|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Superior)|Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
5949|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Nasal)|Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
5950|NCT02185105|Primary|Anterior Ocular Health - CornealStaining (Superior)|Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
5951|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Temporal)|Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
5952|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Nasal)|Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
5953|NCT02185105|Primary|Lens Fitting - Rotation/Mislocation|Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).|Baseline, 15min & 6hrs|||degrees||Standard Deviation|Mean
5954|NCT02185105|Primary|General Lens Fit - Fit Acceptance|Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
5955|NCT02185105|Primary|Investigator's Assessment of Stability|Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.|15min & 6hrs|||degrees||Standard Deviation|Mean
5956|NCT02185105|Primary|Subjective Rating For Handling - Removal|Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)|1 min|||units on a scale||Standard Deviation|Mean
5957|NCT02185105|Primary|Subjective Rating For Handling - Insertion|Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)|1 min|||units on a scale||Standard Deviation|Mean
5958|NCT02185105|Primary|Subjective Rating For Comfort Preference|Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)|1min, 15min, 3hrs, 6hrs|||percentage of subjects|||Number
5959|NCT02185105|Primary|Subjective Rating For Comfort - Comfort Since Last Visit|Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)|15min, 3hrs, 6hrs|||units on a scale||Standard Deviation|Mean
5960|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Central)|Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs|||units on a scale||Standard Deviation|Mean
5961|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Acceptance|Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
5962|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Deposits|Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
5963|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Wettability|Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)|15min & 6hrs|||units on a scale||Standard Deviation|Mean
5964|NCT02184494|Other Pre-specified|Fatigue/Depression Assessment|"Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.~Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms."|Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus unable to be added to analysis.||units on a scale||Standard Deviation|Mean
5987|NCT02181517|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit.||letters||Standard Deviation|Mean
5965|NCT02184494|Other Pre-specified|Health and Activity Questionnaire|"Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant’s degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.~Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant’s ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence."|Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus, clearly unable to be added to analysis.||units on a scale||Standard Deviation|Mean
5966|NCT02184494|Other Pre-specified|Neurological Function|Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.|Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.|The MS and healthy, older adults populations were not required to be assessed with the UPDRS because the assessment materials were for PD populations, specifically.||units on a scale||Standard Deviation|Mean
5967|NCT02184494|Secondary|Resting Energy Expenditure|Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.|Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.|"1 of the 12 PD participants had severe claustrophobia, and could not tolerate the breathing mask on their face.~1 of the 12 PD participants, and 1 of the 8 healthy, older adults participants: dysfunctional equipment, and thus invalid results."||kcal||Standard Deviation|Mean
5968|NCT02184494|Primary|Blood Lactate Response|Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise|Before, immediately after, and 10 minutes after the squatting exercise protocol|"2 of the 8 participants in the healthy, older adults group did not return for this visit, and thus, were not included in analysis.~1 of the 12 MS participants did not return for this visit, and thus, were not included in analysis."||mmol/L||Standard Deviation|Mean
5969|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for HCTZ|Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5970|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for HCTZ|Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5971|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Amlodipine|Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5972|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Amlodipine|Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5973|NCT02183675|Secondary|Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours|Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state|0-6 hours (h), 6-12h and 12-24h after drug administration on day 10|PK set||mg||Geometric Coefficient of Variation|Geometric Mean
5974|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Telmisartan|Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
5975|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Telmisartan|Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
5976|NCT02181530|Secondary|Time to OZURDEX® Re-Injection in the Study Eye||Up to 17 Months|All participants who had OZURDEX® re-injection.||days||Standard Deviation|Mean
5988|NCT02181140|Secondary|Complication Rates|Complication rates of EUS FNA|day 0 and day 14|||participants|||Number
9191|NCT02063230|Primary|Dose Normalized AUC, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
5977|NCT02181530|Secondary|Time to Improvement of 3 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported.|Baseline, Up to 17 Months|All participants with improvement of 3 lines or more in BCVA.||days||Standard Deviation|Mean
5978|NCT02181530|Secondary|Time to Improvement of 2 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported.|Baseline, Up to 17 Months|All participants with improvement of 2 lines or more in BCVA.||days||Standard Deviation|Mean
5979|NCT02181530|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the given time-point.||μm||Standard Deviation|Mean
5980|NCT02181530|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 17 Months|All participants.||percentage of participants|||Number
5981|NCT02181530|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 17 Months|All participants.||percentage of participants|||Number
5982|NCT02181530|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the time-point.||units on a scale||Standard Deviation|Mean
5983|NCT02181517|Secondary|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 16, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||microns||Standard Deviation|Mean
5984|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||percentage of participants|||Number
5985|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||percentage of participants|||Number
5986|NCT02181517|Secondary|Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.||letters||Standard Deviation|Mean
5989|NCT02181140|Secondary|EUS Pro Core FNA: Histology Samples|Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples|day 0 and day 14|Histology (not cytology) samples for Pro-core Needle||participants|||Number
6181|NCT02171247|Primary|Attenuation of the Ascending Aorta and Coronary Arteries|The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.|during scan, approximately 3 hours|||CNR||Standard Deviation|Mean
5990|NCT02181140|Primary|Diagnostic Accuracy|"Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts.~The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard."|up to 1 year|||Diagnostic accuracy (%)|||Number
5991|NCT02181127|Secondary|Documented Episodes of Nausea and Fraction on Glucagon vs. Placebo Days||2 weeks||||||
5992|NCT02181127|Secondary|Total Glucagon Dosing (mcg/kg/24 Hours)||2 weeks||||||
5993|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM – 7:00 AM)||2 weeks||||||
5994|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM – 7:00 AM)||2 weeks||||||
5995|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM – 11:00 PM)||2 weeks||||||
5996|NCT02181127|Secondary|• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM – 11:00 PM)||2 weeks||||||
5997|NCT02181127|Secondary|Insulin Total Daily Dose||2 weeks||||||
5998|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia||2 weeks||||||
5999|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia||2 weeks||||||
6000|NCT02181127|Secondary|• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise||2 weeks||||||
6001|NCT02181127|Secondary|Mean BG During Exercise||2 weeks||||||
6002|NCT02181127|Secondary|Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl||2 weeks||||||
6003|NCT02181127|Secondary|Percentage of Study Days With Mean BG < 154 mg/dl||2 weeks||||||
6004|NCT02181127|Secondary|Percentage of All BG Values Less Than 70 mg/dl||2 weeks||||||
6005|NCT02181127|Secondary|Percentage of the Above Subset of BG Values Less Than 70 mg/dl||2 weeks||||||
6006|NCT02181127|Secondary|Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime||2 weeks||||||
6007|NCT02181127|Secondary|Number of Hypoglycemic Events as Determined From BG Measurements||2 weeks||||||
6008|NCT02181127|Secondary|MARD vs. All BG Measurements||2 weeks||||||
6009|NCT02181127|Secondary|Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime||2 weeks||||||
6010|NCT02181127|Secondary|Mean CGMG During Exercise||2 weeks||||||
6011|NCT02181127|Secondary|Percentage of Subjects With Mean CGMG < 154mg/dl||2 weeks||||||
6012|NCT02181127|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements.|"Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean):~< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl"|2 weeks||||||
6013|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 70 mg/dl||2 weeks||||||
6014|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 60 mg/dl||2 weeks||||||
6015|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 50 mg/dl||2 weeks||||||
6016|NCT02181127|Secondary|Time With CGM Glucose Less Than 70 mg/dl Overnight and During Daytime||2 weeks||||||
6017|NCT02181127|Primary|Continuous Glucose Monitor (CGM) Glucose Area Over the Curve and Less Than 60 mg/dl||2 weeks|||mg/dl/min||Standard Deviation|Mean
6018|NCT02180893|Secondary|Participant Satisfaction Score|Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)|48 hours|||units on a scale||Standard Deviation|Mean
6019|NCT02180893|Secondary|Participant Satisfaction|Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)|48 hours|||"percentage of yes responders"|||Number
6020|NCT02180893|Primary|Visual Analog Scale (VAS) Pain Scores|Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain|24 hours|||units on a scale||Standard Deviation|Mean
6021|NCT02180893|Primary|Postoperative Fentanyl||24 hours|||microgram/kilogram||Standard Deviation|Mean
6022|NCT02180828|Secondary|Total Adverse Events|Total adverse events(cases)|at day 7-14 follow up|||participants|||Number
6023|NCT02180828|Secondary|Adverse Events 4|Skin sensitivity, urticaria rash, erythematous rash, irritation|at day 7-14 follow up|||participants|||Number
6024|NCT02180828|Secondary|Adverse Events 3|Gastrointestinal tract: abdominal pain, diarrhoea, nausea|at day 7-14 follow up|||participants|||Number
6025|NCT02180828|Secondary|Adverse Events 2|Vulvovaginal pruritus, burning, irritation, and bleeding|at day 7-14 follow up|||participants|||Number
6026|NCT02180828|Secondary|Adverse Events 1|Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.|at day 7-14 follow up|||participants|||Number
6027|NCT02180828|Primary|Therapeutic Efficacy 4|Mycological cure of clotrimazole group and fluconazole group|at days30-35 follow-up|||participants|||Number
6028|NCT02180828|Primary|Therapeutic Efficacy 3|Mycological cure of clotrimazole group and fluconazole group|at days 7-14 follow-up|||participants|||Number
6029|NCT02180828|Primary|Therapeutic Efficacy 2|The clinical cure rates of clotrimazole and fluconazol|at days 30-35 follow-up|||participants|||Number
6030|NCT02180828|Primary|Therapeutic Efficacy 1|The clinical cure rates of clotrimazole and fluconazol|7-14 days after treatment (=visit 2)|PPS||participants|||Number
6031|NCT02180646|Other Pre-specified|Post-meal Glucagon-like Peptide-1 (GLP-1) Level||Baseline and 32 times at 5-30 minute intervals over 4 hours.||||||
6032|NCT02180646|Other Pre-specified|Post-meal Insulin Level||Baseline and 32 times at 5-30 minute intervals over 4 hours.|||min*pg/ml||Standard Error|Mean
6033|NCT02180646|Secondary|Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP)||Baseline and 32 times at 5-30 minute intervals over 4 hours.|||min*pg/ml||Standard Error|Mean
6034|NCT02180646|Primary|Plasma Glucose Level Post-meal||Baseline and 32 times at 5-30 minute intervals over 4 hours.|||min*pg/ml||Standard Error|Mean
6035|NCT02180230|Secondary|Cumulative Survival Rates of the Implants|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|implant insertion to follow-up visits (6, 12, 36 and 60 months)|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.||percentage of surviving implants|Participants||Number
6036|NCT02180230|Primary|Marginal Bone Remodeling|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.~Missing data was not imputed and not included in evaluation."|from implant insertion to 6, 12, 36 and 60 months|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.||mm|Participants|Standard Deviation|Mean
6037|NCT02180061|Secondary|ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC)|The ORR, using irRC, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (irCR; complete disappearance of all tumor lesions, whether measureable or not, and no new lesions) or a Partial Response (irPR; decrease in sum of the products of the 2 largest perpendicular diameters of 50% or greater) at any time during the study, based on central radiology review.|Up to 24 months|The FAS population consisted of all allocated participants who had irRC measurable lesions at the Baseline scan as assessed by central independent radiology review and received at least one dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
6038|NCT02180061|Secondary|ORR Per Investigator Assessment Using RECIST 1.1|The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.|Up to 24 months|The FAS population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by Investigator review and received at least one dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
6039|NCT02180061|Primary|Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Up to 24 months|The Full Analysis Set (FAS) population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
6040|NCT02180061|Primary|Number of Participants Discontinuing Treatment Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to last dose of study drug (Up to 24 months)|The APaT population consisted of all participants who received at least one dose of study drug.||Participants|||Number
6041|NCT02180061|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
6042|NCT02179424|Secondary|Smoking Reduction|Reduced at least 50% of cigarette consumption|6 month follow-up and 12 month follow-up|||participants|||Number
6043|NCT02179424|Primary|Smoking Quit Rate|smoking quit rate was defined as the self-reported 7-day point prevalence abstinence|6 month follow-up and 12 month follow-up|In Phase 2, a sample of 642 employees enrolled in the study and chose 1 among the 4 conditions for smoking cessation.||participants|||Number
6044|NCT02179424|Primary|Employers' KAP|"A questionnaire aimed to examine the employers'/ managerial staff’s knowledge, attitudes and practices in promoting smoking cessation in the workplace.~The questionnaires consist of three parts:~Employers's knowledge was assessed by measuring the average number of correct answers on questions about smoking and quitting (Scale 1-7).~Employers' attitude was assessed by measuring the average number agreeing items about their willingness to support employees to quit which included implementation of measures to show support for smoking cessation in the workplace or participation in smoking cessation programme (Scale 1-17).~Employers' practice was assessed by the level of smoking ban in the workplace as reported by the employer. (Scale 1-4; 1: not prohibited, 2: prohibited by not strictly, 3: Strictly prohibited and 4: absolutely strictly prohibited)."|Before the health talk|In Phase 1, questionnaires were sent out to 580 companies and 292 of the company employers returned the complete questionnaire. These 292 employers were not participating in the Phase 2 of this study.||units on a scale||Standard Deviation|Mean
6045|NCT02179398|Secondary|Specificity of Standard Biological Marker for SBI|Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation|||percentage of patients (specificity)||95% Confidence Interval|Number
6046|NCT02179398|Secondary|Sensitivity of Standard Biological Marker for SBI|Sensitivity of standard biological marker for SBI: WBC ≥ 15’000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation|||percentage of patients (sensitivity)||95% Confidence Interval|Number
6047|NCT02179398|Secondary|Specificity of a Lab-score ≥ 3||at 72 hours from PED presentation|||percentage of patients (specificity)||95% Confidence Interval|Number
6048|NCT02179398|Secondary|Sensitivity of a Lab-score ≥ 3||at 72 hours from PED presentation|||percentage of patients (sensitivity)||95% Confidence Interval|Number
6052|NCT02178995|Post-Hoc|Hit Reaction Time (Open-Label)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.|||Milliseconds||Standard Deviation|Mean
6053|NCT02178995|Post-Hoc|Hit Reaction Time (Double Blind)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.|||ms||Standard Deviation|Mean
6054|NCT02178995|Post-Hoc|Remaining CPT Variables (Double-blind Portion)|"Remaining CPT variables are automatically calculated by the program. They were not pre-specified variables of interest nor intentional post-hoc analyses. They are included ONLY for completeness of data submission.~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Placebo vs 10mg vs 20mg (visits 2, 3, 4)|||Units||Standard Deviation|Mean
6055|NCT02178995|Post-Hoc|Remaining CPT Variables (Open-label)|"These are automatically-calculated CPT variables which were not pre-specified variables of interest or intentional post-hoc analyses. They are included ONLY for completeness of data. They include hit reaction time (HRT), variability (VAR), and perseverations (PRS).~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Baseline vs end of open-label (week 8)|Note: One participant's CPT data was invalid||Units||Standard Deviation|Mean
6056|NCT02178995|Post-Hoc|QOLIE-89 Additional Subscales (Open-label)|"These are the remaining subscales of the QOLIE-89. These were not pre-specified variables of interest or intentional post-hoc analyses, but are automatically calculated in scoring the QOLIE-89 and are included ONLY for completeness of data submission.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Visit 1 (baseline) vs end of open-label (week 8)|||Points||Standard Deviation|Mean
6057|NCT02178995|Other Pre-specified|Neuropsychiatric Questionnaires|"Beck Depression Inventory, Beck Anxiety Inventory, Apathy Evaluation Scale. These were not primary or secondary variables of interest given methylphenidate's primary expected action being on cognition. Included given one author's interest, as other studies suggesting psychiatric improvements (particularly apathy and depression) with methylphenidate.~BDI is a common clinical and research measure of depression. It has 21 questions and is scored 0 (no depression) to 63 (most severe depression). A higher score is worse.~BAI is a measure of anxiety, which also has 21 questions and is scored 0 (no anxiety) to 63 (most severe anxiety). A higher score is worse.~AES is a measure of clinical apathy, and is an 18-item scale. It rates symptoms as not at all, slightly, somewhat, or a lot, which are then converted to numerical values 1 (least apathy) to 4 (most apathy). Scores range from 18 (no apathy) to 72 (most apathy)."|Baseline (Visit 1) vs end of Open-label (week 8)|||Points||Standard Deviation|Mean
6058|NCT02178995|Other Pre-specified|Stimulant Side-effects Checklist|"This is a questionnaire covering common stimulant side-effects, intended to help monitor for any significant or common adverse effects.~The scale lists 16 common stimulant side effects rated 0 (absent) to 9 (serious). Minimum score is 0, maximum is 144. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)|||Points||Standard Deviation|Mean
6059|NCT02178995|Other Pre-specified|Adverse Events Profile (Open-Label)|"This is a side-effects reporting scale for anti-epileptic medications. Because it encompasses cognitive and non-cognitive side effects, it was not considered one of our main cognitive/quality of life outcomes of interest. It is used in other studies of AED side effects, however, so was included.~The scale consists of 19 symptoms rated 1 (Never a problem) to 4 (Always or often a problem). Minimum score is 19, maximum score is 76. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)|||Points||Standard Deviation|Mean
6060|NCT02178995|Secondary|CPT Outcomes (Secondary Variables) (Open-label Portion)|"Omissions, commissions, and hits~Hits” represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions” are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions” are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Baseline (Visit 1) vs end of Open-label (week 8)|Note: one epilepsy participant's CPT data was invalid/unusable due to pressing the wrong button during the trial.||Points||Standard Deviation|Mean
6061|NCT02178995|Secondary|QOLIE-89 Selected Cognitive Subscales (Open-label)|"Pre-selected secondary variables were cognitive subscales on the QOLIE-89 felt likely to be affected by MPH: attention/concentration; memory; language; energy/fatigue.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Comparing baseline (visit 1) to end of open-label (end of week 8)|||Points||Standard Deviation|Mean
11611|NCT01976806|Secondary|Serum High-sensitivity C-reactive Protein|Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.|Baseline and 3 months||||||
6062|NCT02178995|Secondary|Seizure Frequency/Severity (Double-blind Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Seizure rate during 28 days prior to study compared to during randomized, single-dose portion, rate adjusted to seizures per 28 patient days.|Only participants who were present in both groups are included here.||Seizures per 28 at-risk days||Standard Deviation|Mean
6063|NCT02178995|Secondary|CPT Scores (Double-blind Portion) (Secondary Variables)|"Secondary variables in CPT: hits, omissions, commissions~Hits” represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions” are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions” are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Difference between scores on MPH 20mg, 10mg, or placebo during randomized visits weeks 2, 3, or 4|||Units||Standard Deviation|Mean
6064|NCT02178995|Primary|QOLIE-89 Aggregate Score|"QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects. The aggregate score is the overall calculated score. Note: most of its questions are specific to patients with epilepsy, and therefore the questionnaire cannot be validly completed by healthy controls. Therefore, only participants with epilepsy completed the questionnaire.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Change from baseline to end of methylphenidate open label treatment (end month 2)|||Points||Standard Deviation|Mean
6065|NCT02178995|Primary|Seizure Frequency (Open-label Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Randomized portion is followed by 1-month open-label portion.|This analysis only compares the 28 participants who were present in both groups. Participants who participated only in the double-blind portion are represented in that analysis.||Seizures per 28 at-risk days||Standard Deviation|Mean
6066|NCT02178995|Primary|MCG (Open-label Portion)|MCG paragraph memory test is a measure verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.|||Points||Standard Deviation|Mean
6067|NCT02178995|Primary|Symbol-digit Matching Test (Open Label Phase)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.|||points||Standard Deviation|Mean
6068|NCT02178995|Primary|Conners CPT Outcomes (Primary Variables) (Open-Label Portion)|"Within-groups comparison (between visit 1 and visit 5 within patients with epilepsy, comparing scores at baseline to scores on methylphenidate) as well as a comparison against healthy controls who repeated the cognitive measures an equal number of times (to assess and control for test/retest and placebo improvements).~D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|Difference between scores at baseline (visit 1) and on methylphenidate open-label (visit 5), compared to untreated healthy controls|PLEASE NOTE: One participant with epilepsy did not record any usable data for Conners CPT due to pressing the wrong key throughout large portions of the trial. Therefore, he is not included in CPT variables (but is included in other analyses).||Units||Standard Deviation|Mean
6069|NCT02178995|Primary|MCG Paragraph Memory Test (Double-blind Portion)|MCG paragraph memory test is a measure of verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo, randomized to be given at weeks 2, 3, or 4|||Points||Standard Deviation|Mean
6070|NCT02178995|Primary|Symbol-digit Matching Test (Double-blind Portion)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo during double-blind portion during which medication was randomized to weeks 2, 3, or 4.|||points||Standard Deviation|Mean
6071|NCT02178995|Primary|Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables)|"Scores on this test measure attentiveness/vigilance and response time. Primary measures are: D', HRTSD D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|difference in scores on specific variables between MPH 20mg, 10mg, and placebo (randomized to administration at weeks 2, 3, or 4)|||Units||Standard Deviation|Mean
6072|NCT02178540|Primary|The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device|Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU.|1 Day|The Full Analysis Set (FAS) included all enrolled patients who completed an HF assessment as defined by completion of inhalation of the contents of at least one capsule and related HF assessment.||Patients failing to understand IFU|||Number
6073|NCT02178059|Primary|Maximum Observed Plasma Concentration (Cmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.||nmol/L||95% Confidence Interval|Geometric Mean
6074|NCT02178059|Secondary|Terminal Half-life (t1/2)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||hour||Geometric Coefficient of Variation|Geometric Mean
6075|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
6076|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||nmol*h/L||95% Confidence Interval|Geometric Mean
6077|NCT02178059|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|||hour||95% Confidence Interval|Median
6078|NCT02178059|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.||nmol*h/L||95% Confidence Interval|Geometric Mean
6079|NCT02177201|Primary|Postoperative Vomiting|Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition|First 24 hours postoperative|||participants|||Number
6080|NCT02176525|Secondary|Body Temperature|The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint.|Visit 1, Visit 7|Treated set.||degree (°C)||Standard Deviation|Mean
6081|NCT02176525|Secondary|Assessment of Global Tolerability on a 4-point Scale|The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator.|day 6|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
6082|NCT02176525|Secondary|Number of Patients With Abnormal Findings in Physical Examination|The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study.|up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
6083|NCT02176525|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse event (AE)|up to 14 days|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
6084|NCT02176525|Secondary|Number of Patients With Abnormal Changes in Laboratory Tests|Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events.|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
6085|NCT02176525|Secondary|Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)|Number of patients with a new onset of an abnormal finding by central assessment are presented.|up to 14 days|Treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation. Only patients included having no missing ECG measurements .||participants|||Number
6086|NCT02176525|Secondary|Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).|Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.||participants|||Number
6182|NCT02171247|Primary|Motion Artifact|The outcome will be measured by individual scores. The scores from multiple readers will be averaged.|during scan, approximately 3 hours|Data was not collected and therefore not analysed|||||
23167|NCT01714492|Secondary|Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative|||mm^2|Participants|Standard Deviation|Mean
6087|NCT02176525|Secondary|Plasma Concentration Time Profiles|Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated.|up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6088|NCT02176525|Secondary|Vz/F,ss|"Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||Litre (L)||Geometric Coefficient of Variation|Geometric Mean
6089|NCT02176525|Secondary|CL/F,ss|"Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||Millilitre per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
6090|NCT02176525|Secondary|t1/2,ss|"Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||h||Full Range|Median
6091|NCT02176525|Secondary|λz,ss|"Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||1/h||Full Range|Median
6092|NCT02176525|Secondary|AUC0-∞,ss|"Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
6093|NCT02176525|Secondary|AUCτ,ss|"Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
6094|NCT02176525|Secondary|Tmax,ss|Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||h||Full Range|Median
6095|NCT02176525|Secondary|Cmin,ss|"The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss).~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6096|NCT02176525|Secondary|Cmax,ss|"The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss).~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)"|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6097|NCT02176525|Secondary|AUC0-τ|Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS||Nanogram*hours/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
6098|NCT02176525|Secondary|Tmax|Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS||hours (h)||Full Range|Median
6099|NCT02176525|Secondary|Cmin|Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6100|NCT02176525|Secondary|Cmax|Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|The PK set (PKS) included all patients in the full analysis set (FAS) with evaluable PK data. FAS included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
6101|NCT02176525|Secondary|Time Dependent Change From Baseline in Viral Load (VL)|Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint.|Baseline, up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||log10 (U/L)||Standard Deviation|Mean
6102|NCT02176525|Primary|Virologic Response (VR)|Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented.|Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
6103|NCT02176421|Secondary|Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)|Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject’s overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse).|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
6104|NCT02176421|Secondary|Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure||Percentage of Subjects|||Number
6105|NCT02176421|Secondary|Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure||Percentage of Subjects|||Number
6106|NCT02176421|Secondary|Injector Ease of Use on an 11-Point Scale|The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy).|Day 0|All subjects with data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
6183|NCT02171247|Primary|Image Quality|Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.|during scan, approximately 3 hours|||% of coronary branches visualized|||Number
6107|NCT02176421|Secondary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12|All subjects with data for this outcome measure||Percentage of Subjects|||Number
6108|NCT02176421|Primary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Month 1|All subjects with data for this outcome measure||Percentage of Subjects|||Number
6109|NCT02176356|Secondary|Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area|Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ). Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6110|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant's Perioral Lines Severity|The investigator assessed the participant’s perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) [best], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)[worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6111|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Oral Commissures Severity|The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6112|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Nasolabial Folds Severity|The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) [best], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle). A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6113|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Overall Mid-Face Volume Deficit Using the 6-Point MFVDS|The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) [best], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6114|NCT02176356|Secondary|Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)|The investigator assessed the participant’s eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6115|NCT02176356|Secondary|Change From Baseline in Investigator’s Assessment of the Severity of Crow’s Feet Lines (CFLs) at Maximum Smile Using the FWS|The investigator assessed the severity of the participant’s CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6116|NCT02176356|Secondary|Change From Baseline in Investigator’s Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)|The investigator assessed the severity of the participant’s GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||score on a scale||Standard Deviation|Mean
6117|NCT02176356|Secondary|Participant's Self- Perception of Age (SPA)|Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today? Participants recorded how many years younger or older they thought their facial appearance made them look. A negative result indicates improvement (a younger appearance).|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||years||Standard Deviation|Mean
6118|NCT02176356|Secondary|Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire|Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
6119|NCT02176356|Secondary|Change From Baseline in Social Confidence Using an 8-item Questionnaire|Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
6120|NCT02176356|Secondary|Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)|Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.||years||Standard Deviation|Mean
6121|NCT02176356|Secondary|Change From Baseline in Aging Appearance Using a 7-item Questionnaire|Participants rated how they look now using a 7-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
6122|NCT02176356|Primary|Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire|Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Modified Intent-to-Treat (mITT) population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.||score on a scale||Standard Deviation|Mean
6123|NCT02175212|Secondary|Late Toxicity|"Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.~Scoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer–Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.~CV events were defined according to the World Health Organization criteria"|5 years|||percentage of patients|||Number
6124|NCT02175212|Secondary|Cause-specific Survival|Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse|5 years|||participants|||Number
6125|NCT02175212|Secondary|Overall Survival: Estimated Percentage of Participants Alive at 5 Years|Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.|5 years|||percentage of patients||95% Confidence Interval|Number
6126|NCT02175212|Secondary|Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years|Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).|5 years|||percentage of participants||95% Confidence Interval|Number
6127|NCT02175212|Primary|Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years|Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).|5 years|||percentage of patients||95% Confidence Interval|Number
6128|NCT02175199|Secondary|Lens Comfort 1-10 Scale Response|"Subject was instructed, Please rate your comfort with the study lenses, using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together."|Day 30|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||units on a scale||Standard Deviation|Mean
6129|NCT02175199|Secondary|Lens Comfort Likert Response at Day 14|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only."|Day 14|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||percentage of subjects|||Number
6130|NCT02175199|Primary|Lens Comfort Likert Response at Day 30|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only."|Day 30|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||percentage of subjects|||Number
6131|NCT02175121|Secondary|Apparent Clearance (CL/F)|Apparent oral clearance of PF-06291874.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||L/hr||Geometric Coefficient of Variation|Geometric Mean
6184|NCT02171247|Primary|Contrast to Noise Ratio|Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation − myocardium attenuation) / SD of mean noise attenuation.|during scan, approximately 3 hours|||CNR||Standard Deviation|Mean
6132|NCT02175121|Secondary|Minimum Plasma Concentration (Cmin)|Minimum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6133|NCT02175121|Secondary|Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours)|Area under the PF-06291874 plasma concentration-time profile from time zero to time tau, the dosing interval, where tau=24 hours.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
6134|NCT02175121|Secondary|Time to Reach Cmax (Tmax)|Time to maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||hour (hr)||Full Range|Median
6135|NCT02175121|Secondary|Maximum Plasma Concentration (Cmax)|Maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6136|NCT02175121|Secondary|Percent Change From Baseline in Lipoprotein A|The Lipoprotein A percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6137|NCT02175121|Secondary|Percent Change From Baseline in Apolipoprotein B100|The Apolipoprotein B100 was calculated as the difference between total Apolipoprotein B and Apolipoprotein B48 and analyzed the percent change from baseline (defined as mean of Day 0 and Day 1) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6138|NCT02175121|Secondary|Percent Change From Baseline in LDL Size|The LDL size percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6139|NCT02175121|Secondary|Percent Change From Baseline in Total LDL Particles|Total LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6140|NCT02175121|Secondary|Percent Change From Baseline in Very Small LDL Particles|Very small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6141|NCT02175121|Secondary|Percent Change From Baseline in Small LDL Particles|Small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6142|NCT02175121|Secondary|Percent Change From Baseline in Medium Small LDL Particles|Medium small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6143|NCT02175121|Secondary|Percent Change From Baseline in Large LDL Particles|Large LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6144|NCT02175121|Secondary|Percent Change From Baseline in Oxidized LDL|Oxidized LDL percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6185|NCT02171234|Primary|Total Number of Adverse Events|Total Number of Adverse Events.|up to 20 weeks|||Total Number of AE|||Number
6145|NCT02175121|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6146|NCT02175121|Secondary|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6147|NCT02175121|Secondary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)|LDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6148|NCT02175121|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6149|NCT02175121|Secondary|Percent Change From Baseline in Triglycerides|Triglycerides percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||% (percent change)||Standard Deviation|Mean
6150|NCT02175121|Secondary|Change From Baseline in Fasting Plasma Glucose|Fasting plasma glucose response change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in change from Baseline when different, represents the available number of participants for analysis at post-baseline days.||mg/dL||Standard Deviation|Mean
6151|NCT02175121|Secondary|Change From Baseline in Mean Daily Glucose|The mean daily glucose was determined from the area under the concentration (AUC) of the glucose concentrations measured at nominal times 0, 0.5, 1, 1.5, 2, 4, 6, 10, 12, 15 and 24 hours post dose. Mean daily glucose change from baseline (defined as Day 0) on Day 28.|Baseline and Day 28|The full analysis set (FAS) was used in the analysis of the pharmacodynamic (PD) parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.||mg/dL||Standard Deviation|Mean
6152|NCT02175121|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 msec; >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 milliseconds (msec); >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
6153|NCT02175121|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern|Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
6154|NCT02175121|Primary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
6169|NCT02172755|Secondary|Tmax - Time of Maximum Observed Concentration|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p|||hours||Standard Deviation|Mean
11889|NCT01969435|Primary|Treatment-related Mortality (TRM)|TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant|100 days|||percentage of participants|||Number
6155|NCT02175121|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.||participants|||Number
6156|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Handling of Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available handling of inhaler satisfaction data||Percentage of participants|||Number
6157|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available inhaler satisfaction data||Percentage of participants|||Number
6158|NCT02173769|Secondary|Patient Satisfaction: Overall Satisfaction|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available satisfaction data||Percentage of participants|||Number
6159|NCT02173769|Secondary|General Health of the Patient After 4-6 Weeks|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks.~The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|4-6 weeks|FAS including patients with available PGE score at end of study visit||Percentage of participants|||Number
6160|NCT02173769|Secondary|General Health of the Patient at Baseline|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination.~The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|Baseline|FAS including patients with available PGE score at baseline||Percentage of participants|||Number
6161|NCT02173769|Secondary|Absolute Changes in the PF-10 Score|"Absolute changes in the PF-10 score.~The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|4-6 weeks|FAS||Units on a scale||Standard Deviation|Mean
6162|NCT02173769|Primary|"Percentage of Participants With Therapeutic Success"|"Percentage of participants with therapeutic success defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks.~The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|Baseline and 4-6 weeks|Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.||Percentage of participants|||Number
6163|NCT02173054|Secondary|Reduction of Severity of Acne: Acne Severity Index (ASI)|"The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)~Decrease of ASI score are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week|||units on a scale||Standard Deviation|Mean
6164|NCT02173054|Primary|Skin Tolerability: Transepidermal Water Loss (TEWL)|Skin tolerability was assessed by measuring TEWL with the Tewameter TM300|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.|||g/m^2h||Standard Deviation|Mean
6165|NCT02173054|Primary|Skin Tolerability: Skin Sebum Content and Skin Hydration|Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.|||µg/cm^2||Standard Deviation|Mean
6166|NCT02173054|Secondary|Reduction of Severity of Acne|"Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks~Total acne lesions = inflammatory + noninflammatory acne lesions~Reduction of lesions counts are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week|||Lesions||Standard Deviation|Mean
6167|NCT02173054|Primary|Reduction of Undesirable Effects|"Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.~The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown."|2nd week, 4th week, and 8th week|The reasons for drop out were lack of compliance (n=1, group A: adapalene gel alone) and consent withdrawal at patient's request (n=1, group C: adapalene with Eucerin)||participants|||Number
6168|NCT02172755|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p|||ng.h/mL||Standard Deviation|Mean
6170|NCT02172755|Primary|Maximum Drug Concentration (Cmax)|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p|||ng/mL||Standard Deviation|Mean
6171|NCT02172742|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h|Steady-state Area Under the Plasma Concentration-time Profile Over 24 h of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose|||ng*h/mL||Standard Deviation|Mean
6172|NCT02172742|Secondary|Tmax - Time of Occurrence of Cmax at Steady-state|Time of Occurrence of Cmax Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose|||hours||Full Range|Median
6173|NCT02172742|Primary|Cmax - Maximum Steady-state Plasma Concentration|Cmax - Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
6174|NCT02172625|Secondary|Superoxide Dismutase (SOD)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. This is another protective antioxidant enzyme measured from whole blood. The SOD enzymatic assay from Genova Diagnostics is designed to measure the activity of the SOD enzyme in the cytosol. The SOD assay is designed to measure the activity of SOD enzyme from whole blood. The SOD activity is determined spectrophotometrically based on the ability of the SOD compound to reduce reactive oxygen species in an enzymatic reaction necessary for the produc tion of an optically active compound.|Baseline, 30 days, 57 days, and 88 days|||U/g Hb x 1000||Standard Deviation|Mean
6175|NCT02172625|Secondary|Whole Blood Glutathione Content (GSH)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. The total whole blood glutathione assay is designed to measure the level of glutathione in whole blood. The samples is first completely lysed and proteins are precipitated. The supernatant is then reduced and combined with a spectrophotometrically reactive compound which generates a detectable absorption peak. When compared to known concentrations of glutathione under the same reaction conditions a determination of glutathione levels in blood is determined.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community||umol/L x 10||Standard Deviation|Mean
6176|NCT02172625|Secondary|Total Antioxidant Capacity (TAC)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Total antioxidant capacity (TAC). The TAC measures the overall collective power of the blood to neutralize free radicals. Specifically, the TAC assay measures the antioxidant capacity of a serum sample via the ability of the antioxidants within the sample to neutralize a spectrophotometrically active compound that is optically active when oxidized. The decrease in color intensity of the compound when compared to the standard, Trolox, under the same reaction conditions is equivalent to the serum antioxidant capacity of the serum sample.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community||mmol/L||Standard Deviation|Mean
6177|NCT02172625|Secondary|Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)|"This is a questionnaire that assessed quality of life across 4 domains over the supplementation period.~Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable).~Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable).~Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable).~Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable)."|Baseline, 30 days, 57 days, and 88 days|Healthy community runners.||units on a scale||Standard Deviation|Mean
6178|NCT02172625|Secondary|Glutathione Peroxidase (GPX)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Glutathione peroxidase (GPX). This is a measure of glutathione peroxidase activity in red blood cell lysates sampled fromwhole blood. The level of GPX in the sample is determined spectrophotometrically based on the ability of the compound to catalyze a reduction reac- tion in the presence of glutathione. The change in the absorption level of the substrate is then utilized to determine the level of GPX present in the sample. The result is expressed as units of GPX relative to the gram amount of hemoglobin in the sample.|Baseline, 30 days, 57 days, and 88 days|||U/g Hb||Standard Deviation|Mean
6179|NCT02172625|Primary|Lipid Peroxides (TBARS)|Lipid peroxides (TBARS) is a measure of oxidative damage in the blood. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline, 30 days, 57 days, and 88 days|The values reported here are the values in a fasted state. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559||umol/L||Standard Deviation|Mean
6180|NCT02172625|Primary|5-km Running Time|5-km running performance time was measured twice at the beginning of the study, and then once post-supplementation. The best 5 km time from both initial sessions was counted as the baseline 5-km time. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline and 88 (SD 4) days|Runners from the Louisville, KY, USA, community||minutes||Standard Deviation|Mean
6186|NCT02171234|Secondary|AUC0-τ|"AUC0-τ - Area under the plasma concentration time curve to last measurable time point~Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose"|Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose|||ng.h/ml||Standard Deviation|Mean
6187|NCT02171234|Secondary|Cmax|Cmax - Maximum observed plasma concentration|Day 1 and Day 8|||ng/ml||Standard Error|Mean
6188|NCT02171195|Primary|Total Number of Adverse Events|An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product|up to 20 weeks|||Number of Adverse Events|||Number
6189|NCT02170688|Primary|Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU)|Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement.|baseline, post-dose imaging (approximately 1hr)|||Hounsfield units (HU)||Standard Deviation|Mean
6190|NCT02170688|Secondary|Difference in Volume of Contrast Used, Measured in Milliliters||baseline, post-dose imaging (approximately 1hr)|||Milliliters||Standard Deviation|Mean
6191|NCT02170662|Secondary|Percent Change in Hair Diameter|The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.|Baseline to week 17; Week 17 to week 34|Data not analyzed, and therefore not reported.|||||
6192|NCT02170662|Secondary|Percent Change in the Target Area Vellus Hair Count|Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness|Baseline to week 17; and week 17 to week 34|||Percent change of vellus hair count||Full Range|Mean
6193|NCT02170662|Secondary|Percent Change in the Target Area Terminal Hair Count|Terminal hairs are those which grow beyond a cm and contribute to overall hair density.|Baseline to week 17; and week 17 to week 34|||percent change of terminal hair count||Full Range|Mean
6194|NCT02170662|Primary|Percent Change in Target Area Total Hair Count|The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.|Baseline to week 17; and week 17 to week 34|intention to treat (ITT)||percentage change in total hair count||Full Range|Mean
6195|NCT02170649|Secondary|the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo)||pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||ng.h/mL||Standard Deviation|Mean
6196|NCT02170649|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t)||pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||ng.h/mL||Standard Deviation|Mean
6197|NCT02170649|Secondary|Time of Occurrence of Cmax (Tmax)||pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||hours||Full Range|Median
6198|NCT02170649|Primary|Maximum Observed Plasma Concentration (Cmax)||pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|||ng/mL||Standard Deviation|Mean
6199|NCT02170532|Secondary|Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.|||||
6200|NCT02170532|Secondary|Change in Tremor Assessment Measured by a Scale|Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).|Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.|||||
6201|NCT02170532|Secondary|Change in Heart Rate||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.|||||
6202|NCT02170532|Secondary|Change in 8 Hour Area-under-the-curve FEV1||0 to 8 hours post dose|||percentage of change||Standard Deviation|Mean
6203|NCT02170532|Primary|Change in Maximum Forced Expiratory Volume at One Second (FEV1)||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|The same 10 subjects received each of the 5 treatments in the same order. Subjects 1-5 were not included in 6 and 8 hour time points.||percentage of change||Standard Deviation|Mean
6204|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
6205|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline|SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.||percent change||Standard Deviation|Mean
6206|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
6207|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter.||percent change||Standard Deviation|Mean
6208|NCT02170519|Primary|Number of Treatment Failures|"Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:~Cardiac Index (CI) >/= 1.8 L/min/m2~Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine~MAP </= 50 mmHg (or as appropriate for age in pediatrics).~SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}"|as long as subject was on drug up to approximately 24 hours|||participants|||Number
6210|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.||percent change||Standard Deviation|Mean
6211|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
6212|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects||percent change||Standard Deviation|Mean
6213|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects||percent change||Standard Deviation|Mean
6214|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline|Readings were taken from the medical record and the data may not have been present at the exact time frames.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects||percent change||Standard Deviation|Mean
6215|NCT02170376|Primary|t1/2 - Terminal Plasma Half-life|t1/2 - Terminal plasma half-life of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||Hours||Standard Deviation|Mean
6216|NCT02170376|Primary|AUC0-5 - AUC Over 5 Hours|AUC0-5 - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng.h/mL||Standard Deviation|Mean
6217|NCT02170376|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.|AUC0-t - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng.h/mL||Standard Deviation|Mean
6218|NCT02170376|Primary|AUC0-∞ - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase|AUC0-∞ of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng.h/mL||Standard Deviation|Mean
6219|NCT02170376|Primary|Tmax - Time of Occurrence of Maximum Plasma Concentration|Tmax - Time to Reach maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||hours||Standard Deviation|Mean
6220|NCT02170376|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration|||ng/mL||Standard Deviation|Mean
6221|NCT02170220|Primary|Cmaxu: Maximum Observed Unbound Plasma Concentration for Vortioxetine|Maximum Observed Unbound Plasma Concentration (Cmaxu) is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
6222|NCT02170220|Primary|AUC(0-inf)u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf)u is a measure of total unbound plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
6223|NCT02170220|Primary|AUC(0-tlqc)u: Area Under the Unbound Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|AUC(0-tlqc)u is a measure of total unbound plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]u).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
6224|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA39835|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
6261|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||hours||Full Range|Median
23168|NCT01714492|Primary|Range of Motion During Flexion of Deep Knee Bend Activity||10 yrs post-operative|||degrees|Participants|Standard Deviation|Mean
6225|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA34443|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
6226|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng/mL||Standard Deviation|Mean
6227|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine Metabolite Lu AA34443|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
6228|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
6229|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA39835|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
6230|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA34443|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
6231|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|Pharmacokinetic (PK) Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.||ng*hr/mL||Standard Deviation|Mean
6232|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 17 (8 weeks after the last dose of study drug)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6233|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6234|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6235|NCT02170207|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6236|NCT02170207|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
6238|NCT02170064|Secondary|Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase|"The efficacy variables were the percentage change in seizure frequency during each 4-week treatment period compared to the baseline phase.~Seizures were recorded in the patient’s diary during the baseline phase and during the following 4-week treatment periods.~Seizure frequency for each patient was standardised to a frequency per 28 days period (i.e., mean daily frequency multiplied by 28). Changes in seizure frequency were analysed for each age group separately."|Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).|||percent change||95% Confidence Interval|Median
6239|NCT02170064|Primary|Time of Occurrence of Cmax (Tmax).||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose|||hours||Standard Deviation|Mean
6240|NCT02170064|Primary|Maximum Observed Plasma Drug Concentration (Cmax) Post-dose||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose|||ng/mL||Standard Deviation|Mean
6241|NCT02169895|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|AUC0-t - area under the plasma concentration-time curve of benserazide.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|||ng.h/mL||Standard Deviation|Mean
6242|NCT02169895|Primary|Tmax - Time of Occurrence of Cmax|tmax - time of occurrence of Cmax of benserazide|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||hours||Full Range|Median
6243|NCT02169895|Primary|Maximum Observed Plasma Drug Concentration (Cmax)|Cmax - Maximum observed plasma drug concentration of benserazide|pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng/mL||Standard Deviation|Mean
6244|NCT02169479|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Area under the plasma concentration-time curve for levodopa|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng.h/mL||Standard Deviation|Mean
6245|NCT02169479|Primary|Tmax - Time of Occurrence of Cmax of Levodopa|Tmax - time of occurrence of Cmax of levodopa.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||hours||Full Range|Median
6246|NCT02169479|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng/mL||Standard Deviation|Mean
6247|NCT02169466|Primary|Tmax - Time to Cmax|Primary pharmacokinetic parameter: tmax - time to Cmax|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||hours||Full Range|Mean
6248|NCT02169466|Primary|AUC0-∞ - AUC From Time Zero to Infinity|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||ng.h/mL||Standard Deviation|Mean
6249|NCT02169466|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||ng.h/mL||Standard Deviation|Mean
6250|NCT02169466|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.||ng/mL||Standard Deviation|Mean
6251|NCT02169453|Primary|AUEC0-24 - Area Under the Effect-time Curve From t=0h to t=24h||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||pmol/mg Hb/h.h||Standard Deviation|Mean
6252|NCT02169453|Primary|tEmax - Time of Occurrence of Emax||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||hours||Standard Deviation|Mean
6253|NCT02169453|Primary|Emax - Maximum Inhibition of COMT Activity|Emax - Maximum inhibition of Catechol-O-Methyltransferase (COMT) activity|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||pmol/mg Hb/h||Standard Deviation|Mean
6254|NCT02169453|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng.h/mL||Standard Deviation|Mean
6255|NCT02169453|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - Area under the plasma concentration-time curve to last measurable time point for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng.h/mL||Standard Deviation|Mean
6256|NCT02169453|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose|||ng/mL||Standard Deviation|Mean
6257|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng.h/mL||Standard Deviation|Mean
6258|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||hours||Full Range|Median
6259|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng/mL||Standard Deviation|Mean
6260|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng.h/mL||Standard Deviation|Mean
12655|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
6262|NCT02169440|Primary|Cmax = Maximum Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng/mL||Standard Deviation|Mean
6263|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng.h/mL||Standard Deviation|Mean
6264|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||hours||Full Range|Median
6265|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.|||ng/mL||Standard Deviation|Mean
6266|NCT02169427|Secondary|Tmax - Time to Attain Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29|||hours||Standard Deviation|Mean
6267|NCT02169427|Secondary|Cmax - Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29|||ng [eq]/mL||Standard Deviation|Mean
6268|NCT02169427|Primary|Cumulative Recovery of [14C]-Radioactivity|"AEurine: Cumulative Recovery of [14C]-Radioactivity in urine AEfaeces: Cumulative Recovery of [14C]-Radioactivity in urine AEair: Cumulative Recovery of [14C]-Radioactivity in urine AEtotal: Cumulative Recovery of [14C]-Radioactivity in urine~Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards"|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29|||Recovery % of dose||Standard Deviation|Mean
6269|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|||ng.h/mL||Standard Deviation|Mean
6270|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
6271|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||hours||Standard Deviation|Mean
6272|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide )|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
6273|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa)|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
6274|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng.h/mL||Standard Deviation|Mean
6275|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||hours||Standard Deviation|Median
6276|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
6277|NCT02169336|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48).|Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|48 hours|||units on a scale||Standard Deviation|Mean
6280|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity|Change in patient global assessment of disease severity assessed by visual analogue scale by the patient from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days||||||
6281|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity|Change in physician global assessment of disease severity assessed by visual analogue scale by a physician from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days||||||
6282|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days|Change in number of symptom free days as assessed by a patient diary from baseline to day 70 after treatment with omalizumab compared to placebo|70 days||||||
6283|NCT02169115|Secondary|To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life|Change in quality of life scores assessed by Dermatology Life Quality Index (DLQI) and UF specific life quality questions from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days||||||
6284|NCT02169115|Primary|Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo|Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.|70 days|||wheal development up to four pins||Standard Deviation|Mean
6285|NCT02168478|Primary|Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)|"ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). 0= no visible erythema; 0.5= slight, barely perceptible erythema; 1= mild erythema; 2= moderate erythema; 3= marked erythema; 4= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization."|48, 96 and 168 Hours|||percentage of patients w allergic rxn|||Number
6286|NCT02168387|Secondary|Change in Quantity and Quality of Suctioned Mucus||baseline and 48 hours|These data were not obtained due to technical difficulties.|||||
6287|NCT02168387|Secondary|Change in Capnography (Vd/Vt)|The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement.|baseline and 48 hours|||ratio||Standard Deviation|Mean
6288|NCT02168387|Primary|Improvement of Atelectasis|"An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows:~0 Complete resolution of collapse~Partial collapse of 1 segment or lobe~Partial collapse of ≥ 2 segments or lobes~Complete collapse of 1 segment or lobe~Complete collapse of ≥ 2 segments or lobes~In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation)."|after 48 hours of therapy|||participants|||Number
6289|NCT02168361|Secondary|Serum HCV RNA Level||4 and 12 weeks into therapy|All participants that received at least a single dose of medication||IU/ml||Full Range|Median
6290|NCT02168361|Primary|Proportion of Participants With Sustained Virologic Response 12 (SVR-12)|Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy|12 weeks post-therapy|All participants that received at least a single dose of medication||participants|||Number
6291|NCT02167867|Primary|Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6|Circumference in inches for the waist, hips and both thighs were measured and added together to give a total circumference measurement at baseline and at the end of the 2 weeks of treatment. The change in the total circumference measurement from baseline to the end of treatment was calculated. A decrease (-) in circumference measurement suggests study success and an increase (+) in circumference measurement suggests study failure. A decrease (-) of 3.52 inches (-3.52 inches) or more is positive for study success based on prior published results.|Baseline and 2 weeks|||inches||Standard Deviation|Mean
6292|NCT02167867|Primary|Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions.|The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated|two weeks|||participants|||Number
6293|NCT02167867|Primary|Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments|The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated.|Baseline|||participants|||Number
6294|NCT02167815|Secondary|Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.||16 weeks|the way to collect data differed to much betwen the sites, no analysis could be done.|||||
6295|NCT02167815|Secondary|Users Feedback After Handling or Use as a Measure of Performance.|"Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor~1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition."|16 weeks|||participants|||Number
6296|NCT02167815|Secondary|Pain Scores on the Visual Analog Scale|Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.|16 weeks|||units on a scale (VAS)||Standard Deviation|Mean
6297|NCT02167815|Primary|Changes From Baseline in Condition of the Peri Wound Skin|Deteriorationin of skin condition , Mepilex XT and Standard care (%)|16 weeks|Intention to treat, change from baseline in condition of the peri-wound skin.||percentage of subjects|||Number
6298|NCT02167139|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 24, Week 52||||||
6299|NCT02167139|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52|||percentage of participants|||Number
6300|NCT02167139|Secondary|ACR20||Week 52|||percentage of participants|||Number
6301|NCT02167139|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24|||percentage of participants|||Number
6302|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events/1,000 person-years|||Number
6303|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events/1,000 person-years|||Number
6304|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events/1,000 person-years|||Number
6305|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events|Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||Number of events per 1,000 person-years|||Number
6306|NCT02166697|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)|SADR are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.||Participants|||Number
6307|NCT02166697|Primary|Number of Participants Reporting One or More Adverse Drug Reactions (ADR)|ADR are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.||Participants|||Number
6308|NCT02165462|Secondary|Age of Patients With Haemophilia||Screening visit|||years||Standard Deviation|Mean
6309|NCT02165462|Secondary|Body Mass Index of Patients With Haemophilia|The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit|||kg/m2||Standard Deviation|Mean
6310|NCT02165462|Secondary|Height of the Patients With Haemophilia|The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit|||cm||Standard Deviation|Mean
6311|NCT02165462|Secondary|Joint Bleeding Before the Assessment||Screening visit|||participants|||Number
6312|NCT02165462|Secondary|Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)|Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).|Screening visit|||participants|||Number
6313|NCT02165462|Secondary|Weight of the Patients With Haemophilia|The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)|Screening visit|||Kg||Standard Deviation|Mean
6314|NCT02165462|Primary|Assessment of Maximal Velocity of Movement|Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum speed (Vmax) was calculated as the maximum value of the first integral of the force-time curve for bilateral contractions, left-sided and right-sided||m/s||Standard Deviation|Mean
6315|NCT02165462|Primary|Assessment of Rate of Development During the Acceleration Phase|Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|||N/s||Standard Deviation|Mean
6432|NCT02159040|Secondary|Rate of Infection|Median number of infections (positive bacterial, viral or fungal culture, or infection requiring IV antimicrobial, or infection resulting in hospitalization or death) in patients treated with azacitidine alone vs. azacitidine + deferasirox|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6316|NCT02165462|Primary|Change of Joint Condition Based on Clinical Assessment|"Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage).~The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4)"|Screening visit|||Units on a scale (range 0-24)||Standard Deviation|Mean
6317|NCT02165462|Primary|Assessment of Rate of Development During the Preparation Phase|Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|||N/s||Standard Deviation|Mean
6318|NCT02165462|Primary|Assessment of Maximal Peak Force|Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum peak force (MPF) is defined as the maximum achieved in the force-time curve during the dynamic test plantar flexion for both bilateral conditions as right and left unilateral, normalized to body weight of the participants (N / kg value)||N/kg||Standard Deviation|Mean
6319|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Acceleration Phase|Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"||percentage||Standard Deviation|Mean
6320|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Preparation Phase|Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the preparation phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"||percentage||Standard Deviation|Mean
6321|NCT02165462|Primary|Assessment of Bilateral Index of Maximal Peak Force|Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).|Screening visit|"Bilateral rates was calculated during the preparation phase and during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions. Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"||percentage||Standard Deviation|Mean
6322|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the VAS for Pain.|A secondary outcome of this study is pain as measured by the validated visual-analog scale (VAS) for pain. The VAS pain instrument measures pain on a scale from 0 cm (no pain) to 10 cm (extreme pain)|Measured at one month post-injection.|||centimeters measured on a visual scale||Standard Deviation|Mean
6323|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.|A secondary outcome of this study is the patient-reported sensitivity to coldness as measured by the McCabe Cold Sensitivity score. Patients' answers on this validated instrument are scored on a scale from 0 (no sensitivity) to 400 (extreme sensitivity), where a higher number represents a worse outcome.|Measured at one month post-injection.|||Units on a scale||Standard Deviation|Mean
6324|NCT02165111|Secondary|Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.|A secondary outcome of this study is severity of Raynaud's symptoms as measured by the self-reported Quick-DASH score. The Quick-DASH scores measures the degree of hand and upper extremity function on a scale of 0 (not limited) to 100 (severely limited) where a higher value represents a worse outcome.|Measured at one month post-injection.|||Units on a scale||Standard Deviation|Mean
6325|NCT02165111|Secondary|Number of Ulcers as Measure of Digital Ulcer Healing|A secondary outcome of this study is the number of digital ulcers as determined by clinical examination. Mean number of ulcers was calculated as total number of ulcers / total number of hands in each group.|Measured at one month post-injection.|||Number of ulcers||Standard Deviation|Mean
6326|NCT02165111|Secondary|Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.|"Raynaud's Condition Score is a patient-reported, validated outcomes scale that measures the severity of Raynaud's phenomenon on a scale of 0 (No difficulty) to 10 (Extreme difficulty), where higher values represent a worse outcome.~Data from each weekly report were combined using a statistical model (generalized linear population-average model) to calculate a weekly rate of change for each participant's hand, where a negative value represents a improvement over time and a positive value represents worsening over time."|Weekly rate of change over the four-month study period.|||change in RCS/week||95% Confidence Interval|Mean
6327|NCT02165111|Primary|Change in Digital Blood Flow From Pre- to Post-injection.|The primary outcome measure is change in blood flow to the fingers, from a pre-injection baseline to post-injection follow-up visit as measured by non-invasive laser Doppler imaging.|Measured pre-injection and at one month post-injection.|||Blood flow, measured in LDI flux units,||95% Confidence Interval|Mean
6328|NCT02165072|Primary|Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters.|Day 1 of ICU admission|||Percent change||Standard Deviation|Mean
6329|NCT02165072|Primary|Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury.|Day 1 of ICU admission|||cm||Standard Deviation|Mean
6379|NCT02160990|Secondary|Buffet Meal Intake (kcal)|"Five hours after the standard egg meal ingested to measure gastric emptying, subjects were invited to eat, over a 30 minute period, a standard all you can eat meal. This meal consisted of either meat or vegetable lasagna, vanilla pudding, and skim milk. Personnel from the study team weighed the food servings post-meal and reported the amount of food left from single portions partially consumed. The total kcal of the food consumed was analyzed by using validated software."|"Visit 4, approximately 30 minutes after start of all you can eat meal"|||kcal||Inter-Quartile Range|Median
6330|NCT02164539|Secondary|Change in Clinic FEV1 Following 2 Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment Dose at Visit 5/Day 28|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Reversibility was measured at Visit 1 and Visit 2 for study eligibility by change in clinic FEV1 within 20 to 60 minutes following 4 inhalations of albuterol/salbutamol and again measured 3 hours after dosing at Visit 5 by change in clinic FEV1 30 minutes following 2 inhalations of albuterol/salbutamol. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-albuterol/salbutamol FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.||Liters (L)||Standard Error|Least Squares Mean
6331|NCT02164539|Secondary|Change From Trough in Clinic Forced Expiratory Volume (FEV1) at 3 Hours Post-study Treatment at Visit 5/Day 28|FEV1 was measured in the morning by spirometry. At Visit 5, after trough FEV1 is measured, subject received investigational product. 3 hours post-dose, spirometry was repeated and subject then received 2 puffs of albuterol/salbutamol. After 30 minutes,spirometry was repeated.. Change from Baseline in clinic trough (pre-dose) FEV1 is the difference in the trough value at 3 hours post-dose peak FEV1 and the Baseline value. If the trough value or the Baseline was missing, then change from Baseline was considered as missing. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis done using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-dose trough FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.||Liters (L)||Standard Error|Least Squares Mean
6332|NCT02164539|Secondary|Change From Baseline in Daily Morning (AM) PEF (Pre-dose and Pre-rescue Bronchodilator) Measured at Home and Averaged Over the Last 21 Days of Treatment Phase A|Peak expiratory flow (PEF) stability limit was calculated from AM PEF measurements on the 7 days preceding Visit 3 as mean AM PEF from the available 7 days preceding Visit 3 x 80%. PEF stability limit serves as a benchmark of the participants run-in COPD status and used for comparison during the treatment phase to assess subject safety. Change from Baseline over the last 21 days of Treatment Phase A is the difference between the last 21 days of Treatment Phase A and the appropriate Baseline week. The last 21 days of Treatment Phase A include the AM assessments on the date of Visit 6. AM assessments include the date of Visit 6 and the 20 consecutive days preceding the date of Visit. Analysis performed using analysis of covariance with covariates of treatment, age, sex, Baseline AM PEF, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and from Day 8 through Day 29|ITT Population. Only those participants available at the specified time point were analyzed.||Liters per minute (L/min)||Standard Error|Least Squares Mean
6333|NCT02164539|Secondary|Mean Change From Baseline in E-RS Total Scores at the End of Treatment Phase A|A daily symptoms score for exacerbations of chronic pulmonary disease tool - Respiratory Symptoms (E-RS) is derived by summing the 11 item-level E-RS scores and has a theoretical range of 0-40, with higher values indicating more severe respiratory symptoms. The Baseline E-RS score is defined as the mean within-subject daily score over the 7 days prior to randomization, with data present for a minimum of 4 of the 7 days. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate Baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline score, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.||Score on scale||Standard Error|Least Squares Mean
6334|NCT02164539|Secondary|Mean Change From Baseline in Rescue Medication Use at the End of Treatment Phase A|All participants received the albuterol/salbutamol via MDI as a rescue medication on an as-needed basis. Total daily rescue medication use for a given day is the sum of daytime albuterol/salbutamol use recorded in PM and nighttime albuterol/salbutamol use recorded in AM the next day. The number of puffs of albuterol (salbutamol) MDI used in the last 12 hours for relief of symptoms were recorded morning and evening in the eDiary by the participants. End of Treatment Phase A is the last 7 days of Treatment Phase A. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline rescue medication use, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.||Puffs||Standard Error|Least Squares Mean
6335|NCT02164539|Primary|Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29)|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 value obtained at Visit 6, approximately 24 hours after morning dosing on Visit 5. ITT population is comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and Day 29|ITT Population. Only those participants available at the specified time point were analyzed.||Liters||Standard Deviation|Mean
6336|NCT02164396|Primary|Lid-Parallel Conjunctival Folds (LIPCOF)|LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade).|Baseline, 2-, 4-, 8- and 12-Week Follow-up|The analysis population consists of all subjects that completed the study without a major protocol deviation.||Score|Participants|Standard Deviation|Mean
6337|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
6338|NCT02163915|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
6339|NCT02163915|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||hours||Full Range|Median
6340|NCT02163915|Secondary|Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137|Maximum observed steady-state plasma concentration during a dosing interval.|Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||ng/mL||Standard Deviation|Mean
6341|NCT02163915|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
6342|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
6343|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
6344|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
6345|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
6346|NCT02163915|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 up to Day 14|Safety analysis set was defined as all participants who received at least one dose of study drug.||percentage of participants|||Number
6347|NCT02163733|Secondary|t1/2 of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of the terminal half-life|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||h||Full Range|Geometric Mean
6348|NCT02163733|Secondary|Tmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of time to Cmax|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||h||Full Range|Median
6349|NCT02163733|Secondary|AUC(0-120) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 120 hours|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM*h||Full Range|Geometric Mean
6433|NCT02159040|Secondary|Incidence of Adverse Events|Incidence of adverse events (AEs) overall and by severity, and serious adverse events (SAEs).|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6350|NCT02163733|Secondary|AUC(0-t) of AZ5104 and AZ7550|Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291)|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM*h||Full Range|Geometric Mean
6351|NCT02163733|Secondary|Cmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM||Full Range|Geometric Mean
6352|NCT02163733|Secondary|AUC(0-72) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).||nM*h||Full Range|Geometric Mean
6353|NCT02163733|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||L||Full Range|Geometric Mean
6354|NCT02163733|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||L/h||Full Range|Geometric Mean
6355|NCT02163733|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||h||Full Range|Geometric Mean
6356|NCT02163733|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||h||Full Range|Median
6357|NCT02163733|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
6358|NCT02163733|Secondary|AUC(0-t) of AZD9291|Area under the plasma concentration curve from time zero to last quantifiable dose|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
6359|NCT02163733|Secondary|AUC of AZD9291|Area under the plasma concentration curve from zero extrapolated to infinity|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
6360|NCT02163733|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose|All patients had at least 1 dose AZD9291 and had sufficient postdose PK to determine parameter without important protocol deviations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax). Note 1 patient missing key 8 hour sample so not included in Cmax analysis.||nM||Full Range|Geometric Mean
6361|NCT02163733|Primary|AUC(0-72) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours|Blood samples are collected on Day 1 & Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).||nM*h||Full Range|Geometric Mean
6362|NCT02163421|Primary|Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration|Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis.|Day 1: predose and on multiple time points (up to Day 127)|The pharmacokinetic analysis set included all randomized participants who received study treatment and who had at least 1 measurable pharmacokinetic concentration.||percentage of drug||95% Confidence Interval|Number
6363|NCT02163395|Secondary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at Week 26, Month 24 and Month 36|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.||percentage of participants||95% Confidence Interval|Number
6364|NCT02163395|Secondary|Mean Bone Level Changes (Distal and Mesial)|A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.|Measured at Week 26, Month 12, Month 24 and Month 36|Standardised bone level measurements provided for the ITT population. Missing data were not imputed.||mm||Standard Deviation|Mean
6365|NCT02163395|Secondary|The Implant Success|"According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply.~Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics)~Absence of implant mobility on manual palpation~Absence of any continuous peri-implant radiolucency"|Measured at Week 26, Month 12, Month 24 and Month 36|Implant success rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.||percentage of participants||95% Confidence Interval|Number
6366|NCT02163395|Primary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at 12 months +/- 4 weeks after implant placement|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.||percentage of participants||95% Confidence Interval|Number
6367|NCT02162979|Secondary|Change in Dose of Anti-parkinsonian Medications||7 weeks||||||
6368|NCT02162979|Secondary|"Percent Change in on Time"|"on time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change."|4 weeks||||||
6369|NCT02162979|Primary|Change in Duration of Dyskinesia.||2 weeks||||||
6370|NCT02162680|Primary|Differences in Patients' Perceptions of Pain Between Treatment Methods|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.|at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute|||units on a scale||Standard Deviation|Mean
6371|NCT02161146|Secondary|Conjunctival Hyperemia Score|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.||score on a scale|Participants|Standard Deviation|Mean
6372|NCT02161146|Primary|Ocular Itching Score|Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.||score on a scale|Participants|Standard Deviation|Mean
6373|NCT02161016|Other Pre-specified|Time to Full Weight-bearing|This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.|up to 24 months||||||
6374|NCT02161016|Secondary|CT Scan|A CT scan will be done at 6 months in order to assess bone fusion.|6 months||||||
6375|NCT02161016|Secondary|Foot Ankle Disability Index|The Foot Ankle Disability Index (FADI) is a self-report of function that assesses activities of daily living, with scores ranging from 0 to 100.|24 months||||||
6376|NCT02161016|Secondary|SF-36 Score|The SF-36 is a survey for health and well-being.|24 months||||||
6377|NCT02161016|Primary|AOFAS Foot-and-Ankle Score|The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.|24 months||||||
6378|NCT02160990|Secondary|Aggregate Satiation Symptom Score|"Postprandial fullness, nausea, bloating, and pain were measured 30 minutes after the liquid meal using 100 mm horizontal visual analog scales (VAS). The subscale scores could each range from none(0) to worst ever (100) at the left and right ends of the lines for each symptom. These satiation symptom scores (postprandial fullness, nausea, bloating, and pain) were combined to generate a total scale score with a different total scale range (0 - 400 mm) with 0 mm indicating none and 400 indicating worst ever."|Visit 3, approximately 30 min after ingestion of nutrient drink test|||mm||Inter-Quartile Range|Median
6406|NCT02159547|Primary|Visual Analogue Scale Change|Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.|45 minutes|||units on a scale||95% Confidence Interval|Median
6380|NCT02160990|Secondary|Maximum Tolerated Volume|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 5.|Visit 3, approximately 30 minutes after liquid meal|||mL||Inter-Quartile Range|Median
6381|NCT02160990|Secondary|Satiation Expressed as Volume to Fullness|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Visit 3, approximately 30 minutes after liquid meal|||mL||Inter-Quartile Range|Median
6382|NCT02160990|Secondary|Change in Body Weight||baseline, day 30|||kg||Inter-Quartile Range|Median
6383|NCT02160990|Secondary|Percentage of Gastric Contents Emptied at 1 Hour|Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 1 hour.|Visit 4, approximately 1 hours after radiolabeled meal was ingested|||percentage of meal emptied||Inter-Quartile Range|Median
6384|NCT02160990|Primary|Gastric Emptying Half-time (T 1/2) of Solids|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).|time frame is 30 days after the initiation of dose.|||minutes||Inter-Quartile Range|Median
6385|NCT02160977|Secondary|VAS(Visual Analogue Scale/Score) of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a worse outcome|6 months|||units on a scale||Standard Deviation|Mean
6386|NCT02160977|Secondary|HSS(Hospital for Special Surgery) Score of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a better outcome|6 months|||units on a scale||Standard Deviation|Mean
6387|NCT02160977|Primary|Proprioception of the Knee Post Operation|"Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation.~Scale Name:degree scale range:0~180 degree,and a higher values represent a worse outcome"|six months|||units on a scale||Standard Error|Mean
6388|NCT02160314|Primary|Treatment-emergent Serious Adverse Event|proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event|3 month|Intent-to-treat (ITT)||participants|||Number
6389|NCT02159950|Other Pre-specified|Effects of Tasquinimod on the Inhibition of Immune Cells||Up to week 50|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6390|NCT02159950|Secondary|Time to PSA Progression||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6391|NCT02159950|Secondary|Progression-free Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6392|NCT02159950|Secondary|Overall Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6393|NCT02159950|Secondary|Objective Response Rates (Partial or Complete)||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6394|NCT02159950|Secondary|Immune Response (Arm 2 Only)||Week 0|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6395|NCT02159950|Secondary|Immune Response||Week 50|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6396|NCT02159950|Secondary|Immune Response||Week 26|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6397|NCT02159950|Secondary|Immune Response||Week 10|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6398|NCT02159950|Secondary|Immune Response||Week 6|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6399|NCT02159950|Secondary|Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4|The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.|Up to 3 years|All treated and eligible patients.||participants|||Number
6400|NCT02159950|Secondary|Duration of PSA Response||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6401|NCT02159950|Secondary|Change in PSA Response|PSA doubling time, PSA slope|Baseline to up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6402|NCT02159950|Primary|Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024||Baseline up to 50 weeks|Due a Lack of funding data was not collected and no patients were analyzed.|||||
6403|NCT02159768|Secondary|Transmission of Airtraq View of Larynx|The view of the larynx will be captured by the handphone attached to the Airtraq layryngoscope, and then transmitted to a second investigator.|Intra operative measurement, time frame within 5 minutes|The larynx could be visualized in all 30 patients using the handphone attached to the Airtraq. The images of the larynx could be transmitted to a remote assistant in all 30 patients.||participants|||Number
6404|NCT02159768|Primary|Visualization of Larynx With the Airtraq Laryngoscope and Handphone|The efficacy of viewing the larynx via the handphone attached to the Airtraq laryngoscope will be assessed.|Intra operative|Study participants in whom the Airtraq handphone visualization system was studied||participants|||Number
6405|NCT02159547|Secondary|Adverse Effects|The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.|45th minutes|||participants|||Number
6431|NCT02159040|Secondary|Prevalence of MDS/AML Related Gene Mutations|Prevalence of the following mutations in the study population (TP53, EZH2, ETV6, RUNX1, ASXL1, other mutation that is present in ≥ 5% of patients)|Baseline|Only one patient in trial. No analysis will ever be done.|||||
6407|NCT02159482|Secondary|Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response|The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis.|4 weeks|Five subjects analysed due to one subject not completing blood draws.||percentage of participants|||Number
6408|NCT02159482|Primary|Proportion of Clinical Responders (Complete Response + Partial Response)|Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.|4 weeks|||percentage of participants|||Number
6409|NCT02159365|Secondary|Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period|An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Date of first dose up to 60 days post last dose (approximately 4 years)||08/2018||||
6410|NCT02159365|Primary|Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 at Primary Endpoint|Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|From Day 1 to End of cycle 2 treatment (approximately 56 days)|All Treated Participants||participants||95% Confidence Interval|Number
6411|NCT02159352|Secondary|Number of Participants With Abnormalities in Urinalysis and Other Chemistry Testing Results|Criteria for marked abnormalities on laboratory test results: urinary dipstick blood: ≥2 if pretreatment (PreRx) <1, ≥2 if PreRx is missing or ≥2*PreRx if PreRx ≥1. Urinary microscopic red blood cell (RBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Urinary microscopic white blood cell (WBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Lactate dehydrogenase >1.25*upper limit of normal (ULN) if PreRx ≤ULN, >1.25*ULN if PreRx is missing and >1.5*PreRx if PreRx >ULN.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.||participants|||Number
6412|NCT02159352|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test Results|Criteria for marked abnormalities in test results: Platelet count >1.5*upper limits of normal (ULN) value, >1.5*ULN if pretreatment (PreRx) value is missing, <0.85*lower limit of normal (LLN) if PreRx ≥LLN, <0.85*LLN if PreRx is missing, <0.85*PreRx if PreRx <LLN. Leukocytes >1.2*ULN if LLN ≤PreRx ≤ULN, >1.2*ULN if PreRx is missing, >1.5*PreRx if PreRx >ULN, >ULN if PreRx <LLN, <0.85*PreRx if PreRx <LLN, <0.9*LLN if LLN ≤PreRx ≤ULN, <0.9*LLN if PreRx is missing and <LLN if PreRx >ULN. Lymphocytes >7.5*10^3 c/uL and <0.75*10^3 c/uL. Neutrophils <0.85*PreRx if PreRx <1.5*ULN, <1.5*ULN if PreRx ≥1.5*ULN and <1.5*ULN if PreRx is missing.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.||participants|||Number
6413|NCT02159352|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|Abnormalities in ECG findings included: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, and second- or third-degree heart block.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All participants who received at least 1 dose of study drug||participants|||Number
6414|NCT02159352|Secondary|Number of Participants With Abnormalities in Vital Sign Measurements|Criteria for abnormalities in vital sign measurements: Diastolic blood pressure: Value >90 and change from baseline > 0 or value < 55 and change from baseline <-10. Systolic blood pressure: Value >140 and change from baseline >20 or value <90 and change from baseline <-20. Heart rate: Value >100 and change from baseline >30 or value <55 and change from baseline <-15. Respiration: Value >16 or change from baseline >10. Temperature: Value >38.3°C or change from baseline >1.6°C.|From start of study treatment (Day 1) to study discharge (up to 15 days)|Participants who received at least 1 dose of study drug||participants|||Number
6415|NCT02159352|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (Day 1) to study discharge for AEs (up to 15 days); Day 1 to 30 days after last dose of study treatment for SAEs (up to 44 days)|All participants who received at least 1 dose of study drug||participants|||Number
6416|NCT02159352|Secondary|Dose-normalized Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]/D) of Daclatasvir|AUC(TAU)/D was obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
6417|NCT02159352|Secondary|Dose-normalized Maximum Observed Plasma Concentration (Cmax/D) and Dose-normalized Plasma Concentration Observed at 24 Hours Postdose (C24/D) of Daclatasvir|Cmax/D and C24/D are obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile.||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
6418|NCT02159352|Secondary|Plasma Concentration Observed at 24 Hours Postdose (C24) of Daclatasvir|C24 was obtained from concentration time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6419|NCT02159352|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was obtained from concentration-time plot of daclatasvir by using non-compartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.||hours||Full Range|Median
6420|NCT02159352|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]) for Daclatasvir|AUC(TAU) was the area under the curve from time zero to end of dosing interval. AUC(TAU) was obtained from concentration-time plot of daclatasvir using noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles. Number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
6421|NCT02159352|Primary|Maximum Observed Plasma Concentration (Cmax) for Daclatasvir|Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6422|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||seconds||Standard Deviation|Mean
6423|NCT02159118|Secondary|Operator Satisfaction With Manual Device and Powered Device|Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.|Within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the requires sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||units on a scale||Standard Deviation|Mean
6424|NCT02159118|Secondary|Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device|Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.|within 4 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||units on a scale||Standard Deviation|Mean
6425|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||seconds||Standard Deviation|Mean
6426|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device|number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||needle passes|Participants|Standard Deviation|Mean
6427|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||mm3||Standard Deviation|Mean
6428|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||mm||Standard Deviation|Mean
6429|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.||mm||Standard Deviation|Mean
6430|NCT02159118|Primary|Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device|Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.|within 24 hours of bone marrow sampling procedure|All participants enrolled in the study were included in analysis, as the required sample size for the study was met. No subjects were excluded from analysis. Analysis was made per protocol.||% Hematopoetic tissue present||Standard Deviation|Mean
6434|NCT02159040|Secondary|Change in Serum Ferritin|Change in Serum Ferritin|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6435|NCT02159040|Secondary|Time to AML Transformation|Time to AML transformation is defined as time from the date of the first dose of study treatment to the date of the first documented bone marrow blast count ≥ 20% per WHO classification 1999.|Up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6436|NCT02159040|Secondary|Overall Survival|Overall survival is defined as time from the date of the first dose of study treatment to the date of death from any cause.|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6437|NCT02159040|Secondary|Progression Free Survival|Progression free survival is defined as time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse per IWG 2006 criteria.|Up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6438|NCT02159040|Secondary|Duration of Response|Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse per IWG 2006 criteria.|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6439|NCT02159040|Secondary|Time to Response|Time to response is defined as time from the date of the first dose of study treatment to the date of the first documented hematologic improvement.|up to 24 months|Only one patient in trial. No analysis will ever be done.|||||
6440|NCT02159040|Primary|Overall Response Rate Per IWG 2006 Criteria|ORR (inclusive of CR, PR and HI) per IWG 2006 criteria including erythroid response, platelet response and neutrophil response over the course of one year. Hematologic improvement must be maintained for at least 8 weeks in order to count as HI.|1 year|Only one patient in trial. No analysis will ever be done.|||||
6441|NCT02158442|Primary|Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.|Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the efficacy of Timentin delivered by PILP procedure (Treatment Group) versus intravenous delivery (Control Group) at reducing microbiological load in subjects with diabetes, and significant wound infection of the lower limb.|Day 3|"Treatment Group: 5 of the 5 analyzable microbiological loads resulted in a reduction. 1 was not analyzable.~Control Group: 3 of the 3 analyzable microbiological loads resulted in a reduction. 4 were not analyzable."||participants|||Number
6442|NCT02158247|Primary|Airway Length vs Height in Female||Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
6443|NCT02158247|Primary|Airway Length vs Height in Male||Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
6444|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 23cm.~Conventional method : depth of intubation is 21cm at the medial incisor for female.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
6445|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female|"Risk group is defined as the patients whose airway length from medial incisor to carina is below 23cm.~Conventional method : depth of intubation is 21cm at the medial incisor for female.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
6446|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 25cm.~Conventional method : depth of intubation is 23cm at the medial incisor for male.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
6447|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is below 25cm.~Conventional method : depth of intubation is 23cm at the medial incisor for male.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
6448|NCT02158247|Primary|Comparison of Airway Length Between Male and Female|Airway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.|Endotracheal intubation time|||Centimeters||Standard Deviation|Mean
6449|NCT02158039|Primary|Number of Subjects With Complete or Partial Ablation of the Treated Cyst|Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)|1 year after final treatment|||participants|||Number
6450|NCT02158039|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability|1 year after final treatment|||participants|||Number
6451|NCT02157909|Primary|Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes|With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of “no re-fit,” an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.|Dispense (Day 0), Week 1|This analysis population includes all randomized and treated subjects.||percentage of subjects|||Number
6512|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Second Dose||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.||ng/mL||Standard Deviation|Mean
6452|NCT02157883|Secondary|AUC of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations, where AUC possible to calculate, and including Period 2 data (all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).||nM*h||Full Range|Geometric Mean
6453|NCT02157883|Secondary|Cmax of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of maximum plasma AZ7550 concentration|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and including Period 2 data (since all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).||nM||Full Range|Geometric Mean
6454|NCT02157883|Secondary|AUC of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).||nM*h||Full Range|Geometric Mean
6455|NCT02157883|Secondary|Cmax of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of maximum plasma AZ5104 concentration|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).||nM||Full Range|Geometric Mean
6456|NCT02157883|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||L||Full Range|Geometric Mean
6457|NCT02157883|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||L/h||Full Range|Geometric Mean
6458|NCT02157883|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||hours||Full Range|Geometric Mean
6459|NCT02157883|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||hours||Full Range|Median
6460|NCT02157883|Secondary|AUC(0-t) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration curve from time zero to last quantifiable dose|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM*h||Full Range|Geometric Mean
6461|NCT02157883|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM*h||Full Range|Geometric Mean
6462|NCT02157883|Primary|AUC of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples are collected on Day 1 & Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM*h||Full Range|Geometric Mean
6463|NCT02157883|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration|Blood samples are collected on Day 1 & Day 10 atpre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).||nM||Full Range|Geometric Mean
6464|NCT02157376|Secondary|Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase|"Criteria for a significant upper GI bleeding as described in primary outcome measure or,~Criteria for a non-significant upper GI bleeding as:~Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or,~Persistent gastroccult- positive coffee ground material~During IMP treatment Day 1-2:~Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline.~During IMP treatment Day 3-14:~Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or,~Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.||% of participants|||Number
6465|NCT02157376|Primary|The Proportion of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase|"Criteria for a clinically significant upper GI bleeding as:~Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or,~Persistent gastroccult- positive coffee ground material~During IMP treatment Day 1-2:~Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline.~During IMP treatment Day 3-14:~Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.||% of participants|||Number
6466|NCT02157298|Secondary|Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%|Proportion of participants with mean daily insulin dose reduction greater than or equal 10% from baseline to week 16 (LOCF) between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) value||percentage of participants||95% Confidence Interval|Least Squares Mean
6467|NCT02157298|Secondary|Total Mean Daily Insulin Dose|Mean change in calculated mean daily insulin dose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||IU/Day||95% Confidence Interval|Least Squares Mean
6468|NCT02157298|Secondary|Total Body Weight|Mean change in total body weight from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||kg||95% Confidence Interval|Least Squares Mean
6469|NCT02157298|Secondary|Fasting Plasma Glucose|Mean change in fasting plasma glucose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||mg/dL||95% Confidence Interval|Least Squares Mean
6470|NCT02157298|Primary|Adjusted Mean Change in HbA1c Levels|Mean change in HbA1c levels from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16||percentage of hemoglobin glycosylated||95% Confidence Interval|Least Squares Mean
6471|NCT02157116|Secondary|Overall Survival||Approximately 10 years|Due to insufficient accrual, the study was stopped prior to completing the 10 year followup for survival.|||||
6472|NCT02157116|Secondary|Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction||During induction, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.|||||
6473|NCT02157116|Secondary|Number of Grade III/IV Non-hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.|||||
6474|NCT02157116|Secondary|Number of Grade III/IV Hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.|||||
6475|NCT02157116|Primary|Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy||at the end of the study, estimated 2.5 years|Due to insufficient accrual, gene analysis was not performed.|||||
6476|NCT02157116|Primary|Induction Response|Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.|Between 2 and 3 weeks after induction|Due to insufficient accrual, data analysis was not performed.|||||
6477|NCT02156466|Secondary|Percentage of Subjects With Exacerbation of Psoriasis|Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit >=125% of baseline PASI).|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
6478|NCT02156466|Secondary|Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85|The BSA is the physician’s evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district.|Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85|"Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). Here n signifies those subjects who were evaluable for this outcome measure at the specified time points."||percent change||Standard Deviation|Mean
6499|NCT02156466|Primary|Average Concentration (Cav) Post First Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6479|NCT02156466|Secondary|Percentage of Subjects With Static Physician’s Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline|The static Physician’s Global Assessment (sPGA) scale rated the investigator’s overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported.|Day 8, 15, 22, 29, 36, 43, 50, 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
6480|NCT02156466|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline, Day 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).||units on a scale||Standard Deviation|Mean
6481|NCT02156466|Secondary|Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
6482|NCT02156466|Primary|Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841|The observed serum concentration immediately before second dose.|Pre-dose (0 hours) on Day 15|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6483|NCT02156466|Primary|Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6484|NCT02156466|Primary|Accumulation Ratio of AUC (Racc(AUC))|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
6485|NCT02156466|Primary|Accumulation Ratio of Cmax (Racc (Cmax))|Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
6486|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
6487|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
10605|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
6488|NCT02156466|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||Liters||Geometric Coefficient of Variation|Geometric Mean
6489|NCT02156466|Primary|Apparent Clearance (CL/f) Post Third Dose of MSB0010841|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||L/day||Geometric Coefficient of Variation|Geometric Mean
6490|NCT02156466|Primary|Terminal Rate Constant (λz) Post Third Dose of MSB0010841|Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||1/hour||Geometric Coefficient of Variation|Geometric Mean
6491|NCT02156466|Primary|Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where ‘λz’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
6492|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||hour||Full Range|Median
6493|NCT02156466|Primary|Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||hour||Full Range|Median
6494|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||hour||Full Range|Median
6495|NCT02156466|Primary|Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841|Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
6496|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
6497|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post First Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day||Geometric Coefficient of Variation|Geometric Mean
6498|NCT02156466|Primary|Average Concentration (Cav) Post Third Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6500|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6501|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6502|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
6503|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
6504|NCT02156466|Primary|Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the third dose.|Pre-dose (0 hours) on Day 29|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
6505|NCT02156466|Primary|Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the first dose.|Pre-dose (0 hours) on Day 1|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
6506|NCT02156466|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841|Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*ug/mL||Geometric Coefficient of Variation|Geometric Mean
6507|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6508|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6509|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6510|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||day*microgram per milliliter (day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
6511|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Third Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.||ng/mL||Standard Deviation|Mean
6513|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After First Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received first dose of MSB0010841 without protocol deviations affecting PK, and who provide evaluable PK data. Here “n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
6514|NCT02156466|Primary|Levels of Pre-existing Anti-MSB0010841 Antibody Titers||Pre-dose on Day 1|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.||log10titer|||Number
6515|NCT02156466|Primary|Levels of Anti-MSB0010841 Antibody Titers||Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.||log10titer|||Number
6516|NCT02156466|Primary|Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])|Data were presented for MSB0010841 combined group and placebo.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).||percentage of subjects|||Number
6517|NCT02156466|Primary|Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)|Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value > 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.|Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “Number of subjects analyzed” signifies those subjects who were evaluable for this endpoint and “n” signifies those subjects who were evaluable at the specified time point.||mm|||Number
6518|NCT02156466|Primary|Number of Subjects With Local Injection Site Reactions (ISRs)|The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising area); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising area); Severe (>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable ‘firmness’ only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.|Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “n” signifies those subjects who were evaluable for the specified injection site reaction. Subjects may be represented in more than 1 category.||subjects|||Number
6519|NCT02156466|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).||subjects|||Number
6520|NCT02156271|Secondary|Interleukin 6 (IL-6)||Baseline|||pg/mL||Standard Deviation|Mean
6521|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Baseline|||HOMA-IR value||Standard Deviation|Mean
6522|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Baseline|||mg/L||Standard Deviation|Mean
6523|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.|Baseline|||minutes||Standard Deviation|Mean
6524|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Baseline|||minutes||Standard Deviation|Mean
6525|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|day 89 - 90|||units on a scale||Standard Deviation|Least Squares Mean
6526|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Day 89-90|||HOMA-IR value||Standard Deviation|Least Squares Mean
6527|NCT02156271|Secondary|Interleukin 6 (IL-6)||Day 89-90|||pg/mL||Standard Deviation|Least Squares Mean
6528|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Day 89-90|||ng/mL||Standard Deviation|Least Squares Mean
6529|NCT02156271|Secondary|Change in Total Sleep Time|Change in sleep time will be determined by PSG.|Day -1-0, Day 89-90|Data was not collected, and therefore not analyzed.|||||
6530|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|baseline|||units on a scale||Standard Deviation|Mean
6531|NCT02156271|Primary|Change in Metabolic Syndrome (MetSyn)||Baseline, Day 30, Day 60, Day 89-90|Data was not collected, and therefore not analyzed.|||||
6533|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset.|Day 89-90|||minutes||Standard Deviation|Least Squares Mean
6534|NCT02156167|Primary|Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test|"The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions.~Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810)."|3 months after initial upgraded fitting|One subject did not visit the clinic for the 3 months follow-up, a second subject did not perform the speech in noise test at the 3 months follow-up due to tiredness||dB SNR||Standard Deviation|Mean
6535|NCT02155985|Secondary|Change in Brachial Artery FMD From Baseline to Week 12||12 weeks||||||
6536|NCT02155985|Secondary|Change in 11-dehydrothromboxane B2 From Baseline to Week 12||12 weeks||||||
6537|NCT02155985|Secondary|Change in Serum Thromboxane B2 From Baseline to Week 12||12 weeks||||||
6538|NCT02155985|Secondary|Change in Kynurenine to Tryptophan Ratio From Baseline to Week 12||12 weeks||||||
6539|NCT02155985|Secondary|Change in D-dimer From Baseline to Week 12||12 weeks||||||
6540|NCT02155985|Secondary|Change in IL-6 From Baseline to Week 12||12 weeks||||||
6541|NCT02155985|Secondary|Change in Expression of CTLA-4 on CD8+ From Baseline to Week 12||12 weeks||||||
6542|NCT02155985|Secondary|Change in Expression of CTLA-4 on CD4+ From Baseline to Week 12||12 weeks||||||
6543|NCT02155985|Secondary|Change in Expression of PD-1 on CD8+ From Baseline to Week 12||12 weeks||||||
6544|NCT02155985|Secondary|Change in Expression of PD-1 on CD4+ From Baseline to Week 12||12 weeks||||||
6545|NCT02155985|Secondary|Change in CD8+HLA-DR+ Cell Proportion From Baseline to Week 12||12 weeks||||||
6546|NCT02155985|Secondary|Change in CD8+CD38+ Cell Proportion From Baseline to Week 12||12 weeks||||||
6547|NCT02155985|Secondary|Change in CD4+HLA-DR+ Cell Proportion From Baseline to Week 12||12 weeks||||||
6548|NCT02155985|Secondary|Change in CD4+CD38+ Cell Proportion From Baseline to Week 12||12 weeks||||||
6549|NCT02155985|Secondary|Change in CD69 From Baseline to Week 12||12 weeks||||||
6550|NCT02155985|Secondary|Change in CD16 From Baseline to Week 12||12 weeks||||||
6551|NCT02155985|Secondary|Change in CD14 From Baseline to Week 12||12 weeks||||||
6552|NCT02155985|Secondary|Change in sCD163 From Baseline to Week 12||12 weeks||||||
6553|NCT02155985|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality|16 weeks||||||
6554|NCT02155985|Primary|Change in sCD14 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. Differences between arms are expressed as the percent difference between mean fold changes."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population. Participants 1) without baseline AND week 11/12 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) with a serious bacterial infection while on treatment, or 4) with <70% self-reported adherence (based on all available days of recall) to study treatment were excluded.||fold change||95% Confidence Interval|Mean
6555|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
6556|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
10606|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set||Percentage of participants|||Number
6557|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
6558|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
6559|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores|The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
6560|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
6561|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores|The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.||scores on a scale||Standard Deviation|Mean
6577|NCT02154425|Primary|The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable. Measurement on day 28 applies to subjects on a CZP 400mg Q4W dosing regimen only.||mg/kg/day||Full Range|Median
6578|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14|Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6562|NCT02155881|Primary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
6563|NCT02155543|Primary|Maximal Plasma Concentration (Cmax) of AGN-223575|Concentrations of AGN-223575 were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 24 hours post-dose. The Cmax is reported.|Day 15|Pharmacokinetic Population: AGN-223575-treated subjects in cohorts with pharmacokinetic samples (i.e., Cohorts 2 to 5)||Nanograms/Milliliters (ng/mL)||Standard Deviation|Mean
6564|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 14 (2 weeks post injections)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire||Percentage of Participants|||Number
6565|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 0 (post last injection)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire||Percentage of Participants|||Number
6566|NCT02155283|Other Pre-specified|Change in Amount of Pain Determined by the NRS at the 1-week Follow-up After the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|4 weeks|||units on a scale||Standard Deviation|Mean
6567|NCT02155283|Secondary|Change in Heart Rate Variability (and the Autonomic System)|"Gather information regarding:~Autonomic nervous system activity by measuring heart rate variability (HRV)."|3 weeks, 4 weeks||||||
6568|NCT02155283|Secondary|Change in Symmetry of Muscle Function on Either Side of the Spine|"Gather information regarding:~Symmetry of muscle function about the spine using static surface electromyography (SEMG)"|3 weeks, 4 weeks||||||
6569|NCT02155283|Secondary|Change in Functional Health Status by ODI|Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)|3 weeks, 4 weeks||||||
6570|NCT02155283|Secondary|Change in Proprioception and Vestibular Function.|"Gather information regarding:~Balance and Fall Prevention using digital posturography"|3 weeks, 4 weeks||||||
6571|NCT02155283|Primary|Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|3 weeks|Completers per protocol||units on a scale||Standard Deviation|Mean
6572|NCT02155010|Secondary|Patient's Anxiety|We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.|up to 3 days|||points||Standard Deviation|Mean
6573|NCT02155010|Primary|Incidence of Hypotension|We compare incidence rate of hypotension during infusion of dexmedetomidine|up to 3 hours|||participants|||Number
6574|NCT02154906|Secondary|Change in Radiographic Bone Level|measurement of radiographic bone level at the time of surgical intervention will be compared with measurement of bone level 6 months after surgery|baseline and 6 months after surgery|||mm||Standard Deviation|Mean
6575|NCT02154906|Primary|Change in Clinical Attachment Level (CAL)|measurement of CAL at the time of surgical intervention will be compared with measurement of CAL and bone level 6 months after surgery|baseline and 6 months after surgery|||mm||Standard Deviation|Mean
6576|NCT02154425|Primary|The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)|Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.|From Day 0 to Day 14 or 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6596|NCT02154386|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|after removal of bone core from site of dental implant placement at 18-20 weeks following tooth extraction and grafting|||percentage of vital bone||Standard Deviation|Mean
6579|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6580|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6581|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6582|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6583|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6584|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||mg/kg/day||Full Range|Median
6585|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6586|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14|Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Mean
6587|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6588|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6589|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6590|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6591|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6592|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6593|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0|Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.|Day 0|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.||µg/mL||Full Range|Median
6594|NCT02154386|Secondary|Change in Buccal Ridge Height|Ridge height measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge height are determined (negative number signifies loss of ridge height)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting|||change in bone height (mm)||Standard Deviation|Mean
6595|NCT02154386|Secondary|Change in Ridge Width|Ridge width measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge width are determined (negative number signifies loss of ridge width)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting|||ridge width change (mm)||Standard Deviation|Mean
10607|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set||Percentage of participants|||Number
6597|NCT02154139|Secondary|Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy|Recurrence-free survival was determined in participants who were treated with the drug as adjuvant therapy, and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
6598|NCT02154139|Secondary|Percentage of Participants With Progression Free Survival|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
6599|NCT02154139|Secondary|Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions greater than or equal to (>=) 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of >= 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Week 24, 48,96|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants||95% Confidence Interval|Number
6600|NCT02154139|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.||participants|||Number
6601|NCT02154139|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.||participants|||Number
6602|NCT02154087|Primary|Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247|The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects’ quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).|Wound fluid samples were to be collected one week after the initial dose of HP802-247.|Due to the failure of HP802-247-09-029 to show superiority over its vehicle in study 802-247-09-029, this study was terminated after enrollment of one of the proposed 25 subjects. No data was collected.|||||
6603|NCT02154048|Primary|Time to First Analgesic Dose||48 hours|one subject in the Local Anesthetic (LA) Control Group was not analyzed because subject did not return the data sheet||hours||Standard Deviation|Mean
6604|NCT02153827|Secondary|Upper Quarter Y Balance Test|Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.|6 months|||cm of reach divided by limb length||Standard Deviation|Mean
6605|NCT02153827|Secondary|Shoulder Active Range of Motion|Degrees of shoulder elevation with 0 being the least and 180 being the greatest.|6 months|||Degrees||Standard Deviation|Mean
6606|NCT02153827|Secondary|Numeric Pain Rating Scale|0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.|6 months|||units on a scale 0-10||Standard Deviation|Mean
6607|NCT02153827|Secondary|Global Rating of Change|Global rating of change is a single item questionnaire asking about total change since beginning treatment. The scale ranges from -7 (a great deal worse) to +7 (a great deal better). The unit of measure is scores on a scale.|6 months|||units on a scale||Standard Deviation|Mean
6608|NCT02153827|Primary|Change in Western Ontario Rotator Cuff Index|shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.|6 months|||units on a scale derived from 100cm vas||Standard Deviation|Mean
6745|NCT02150460|Primary|Complications of Local Anaesthetic Injection|"Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc~Local complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc"|0,10 and 15 minutes|||participants|||Number
23681|NCT01706588|Secondary|Rescue Medication Consumption||consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery||||||
6609|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
6610|NCT02153788|Secondary|Mean Change in the Distress Thermometer|A clinical tool that has been validated widely especially in cancer patients, to detect clinically significant emotional distress. This is a one-item scale that asks participants to rate their distress on scale from 0-100. Lower scores represent less distress and higher scores indicate greater distress.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
6611|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
6612|NCT02153788|Secondary|Mean Change in Piper Fatigue Score|A multidimensional scale for measuring fatigue, whose validity and reliability have been established across many patient populations including cancer patients, HIV, pregnancy, and myocardial infarction. There are 22 questions, in 3 subscales that measure behavioral, affective meaning, sensory and cognitive/mood aspects of fatigue, each scored on an 11-point likhert scale with a score of 0-10, 0 indicating no fatigue and 10 indicating the most severe fatigue. The Piper Fatigue Scale can range from 0 to 220 with higher scores indicating greater fatigue.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
6613|NCT02153788|Secondary|Mean Change in Self-reported Total Sleep Time|Mean change in self-reported total sleep time from randomization to the end of the open label phase|Randomization to the end of the open label phase, approximately 1 week|Data not collected, and therefore not analyzed.|||||
6614|NCT02153788|Secondary|Mean Change in Self Reported Total Sleep Time|Mean change in self reported Total Sleep Time from Randomization to Final Study Visit in the placebo-controlled phase.|Randomization to final study visit, approximately 12 weeks|Data not collected, and therefore not analyzed.|||||
6615|NCT02153788|Primary|Mean Change in the Insomnia Severity Index|Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.|Randomization to final study visit, approximately 12 weeks|||units on a scale||Standard Deviation|Mean
6616|NCT02153489|Other Pre-specified|Change From Baseline in Number of Steps Per Day||Week 3 of treatment|||Number of steps per day||Standard Error|Least Squares Mean
6617|NCT02153489|Other Pre-specified|Change From Baseline in Duration of at Least Moderate Activity|Moderate activity was defined as any physical activity >3 metabolic equivalents|Week 3 of treatment|||Minutes||Standard Error|Least Squares Mean
6618|NCT02153489|Other Pre-specified|Change From Baseline in Total Sleep Time||Week 3 of treatment|||Minutes||Standard Error|Least Squares Mean
6619|NCT02153489|Other Pre-specified|Change From Baseline in Sleep Efficiency|Sleep efficiency is calculated as the total sleep time as a proportion of total time in bed|Week 3 of treatment|||Percentage of total time in bed||Standard Error|Least Squares Mean
6620|NCT02153489|Other Pre-specified|Change From Baseline in Proportion of Sleep Stage REM as a Percentage of Total Sleep Time||Week 3 of treatment|||Percentage of total sleep time||Standard Error|Least Squares Mean
6621|NCT02153489|Other Pre-specified|Change From Baseline in Oxygen Desaturation Index (ODI) Per Hour of Total Sleep Time|The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. In this study, any event with a 4% decrease in blood oxygen levels counted towards the total|Week 3 of treatment|||Events/hr||Standard Error|Least Squares Mean
6622|NCT02153489|Other Pre-specified|Change From Baseline in Apnea-hypopnea Index (AHI) Per Hour of Total Sleep Time|The Apnea Hypopnea Index (AHI) is used to indicate the severity of obstructive sleep apnea. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep|Week 3 of treatment|||Events/hr||Standard Error|Least Squares Mean
6623|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Evening Activities|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
6624|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Early Morning Activities|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
6746|NCT02150460|Primary|Supplementary Injection(s)|After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later|5 minutes|||participants|||Number
6625|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Night-time COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
6626|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Evening COPD Symptom Severity|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
6627|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Early Morning COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment|||Score on a scale||Standard Deviation|Mean
6628|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC12-24hr||12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment|||L/sec*hr||Standard Error|Least Squares Mean
6629|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC0-12hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment|||L/sec*hr||Standard Error|Least Squares Mean
6630|NCT02153489|Other Pre-specified|Change From Baseline in Peak FEV1||Week 3 of treatment|||Liters/sec||Standard Error|Least Squares Mean
6631|NCT02153489|Other Pre-specified|Change From Baseline in Morning Trough FEV1||Week 3 of treatment|||Liters/sec||Standard Error|Least Squares Mean
6632|NCT02153489|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment|||L/sec*hr||Standard Error|Least Squares Mean
6633|NCT02153398|Secondary|Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||L||Standard Deviation|Mean
6634|NCT02153398|Secondary|Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||L/h||Standard Deviation|Mean
6635|NCT02153398|Secondary|Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||hour||Standard Deviation|Mean
6636|NCT02153398|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||hour||Full Range|Median
6637|NCT02153398|Secondary|Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||μmol/L||Standard Deviation|Mean
6638|NCT02153398|Secondary|AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.||μmol*h/L||Standard Deviation|Mean
6639|NCT02153398|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the pharmacokinetics (PK).||μmol*h/L||Standard Deviation|Mean
6640|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6796|NCT02147691|Primary|Investigator Global Assessment (IGA) at Baseline|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Baseline|Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis.||units on a scale||Standard Deviation|Mean
13477|NCT01940120|Secondary|Endocarditis|Clinical Event Committee (CEC)-adjudicated diagnosis of endocarditis based on the Duke criteria.|12 months|||participants|||Number
6641|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6642|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6643|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6644|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6645|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6646|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6647|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.||Participants|||Number
6648|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Patient Diaries|"The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
6649|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
6650|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Patient Diaries|"The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
6651|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Patient Diaries|"The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no heartburn at pre-dose in patient diary and obtained available diary data at Week 8.||participants|||Number
6652|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Patient Diaries|"The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
6797|NCT02147561|Secondary|Physician Global Assessment of Outcome on a 3-Point Scale|Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment||Patients|||Number
16177|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Size||Baseline, Week 8|||nm||95% Confidence Interval|Least Squares Mean
6653|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
6654|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Patient Diaries|"The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
6655|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Patient Diaries|"The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8.||Participants|||Number
6656|NCT02153099|Secondary|Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for ENV8058 (TAK-058)|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK population included all enrolled participants.||hours||Standard Deviation|Mean
6657|NCT02153099|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for ENV8058 (TAK-058)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.||ng*hr/mL||Standard Deviation|Mean
6658|NCT02153099|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ENV8058 (TAK-058)|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.||ng*hr/mL||Standard Deviation|Mean
6659|NCT02153099|Secondary|Cmax: Maximum Observed Plasma Concentration for ENV8058 (TAK-058)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|Pharmacokinetic (PK) Population included all enrolled participants.||ng/mL||Standard Deviation|Mean
6660|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse [beats per minute (bpm)], and resting blood pressure and after standing.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
6661|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
6662|NCT02153099|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|Baseline up to Day 30|Safety population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
6663|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function|"Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
6664|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence|"Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
6683|NCT02152371|Secondary|Number of Participants With Dulaglutide Anti-Drug Antibodies|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 12 and 28. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline, Week 12 and Week 28|All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.||participants|||Number
6665|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning|"Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
6666|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening|"Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
6667|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality|"Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
6668|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration|"Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
6669|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset|"Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
6670|NCT02153086|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||number of awakenings||Standard Deviation|Mean
6671|NCT02153086|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||hours||Standard Deviation|Mean
6672|NCT02153086|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||minutes||Standard Deviation|Mean
6673|NCT02153086|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
6684|NCT02152371|Secondary|Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||participants|||Number
6685|NCT02152371|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of cases of acute pancreatitis confirmed by adjudication. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||participants|||Number
6686|NCT02152371|Secondary|Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
6674|NCT02152605|Secondary|Change From Baseline (BL) in Mean Number of Puffs of Rescue Medication Per Day Used Over Weeks 1-12|Albuterol/salbutamol(A/S) was used as rescue medication and was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout treatment periods. The number of puffs of rescue medication (A/S) per day over the entire 12 week treatment period was recorded and analyzed. For rescue use, ‘day’ is referred as the period between one record of rescue use and the next. Total puffs of rescue for each day = number of salbutamol puffs + (2 x number of salbutamol nebules). Analysis performed using mixed model repeated measures with covariates of BL(mean number of total puffs over the duration from First Day; defined as Latest of [7 days before Visit 2 and day after Visit 1] to Last Day(defined as Day before Visit 2)), smoking status, centre group, four-week period, treatment and period by BL interaction. Change from BL used weeks 1-4, 5-8, and 9-12 as covariates in the model and the overall least squares mean change for weeks 1-12 is estimated.|Week 1 amd Week 12|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents all par. in the ITT population without missing covariate information and with at least one post BL measurement.||puffs per day||Standard Error|Least Squares Mean
6675|NCT02152605|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 28, 56 and 84. Baseline is defined as the assessment taken pre-dose on Treatment Day 1. Trough FEV1 is defined as the FEV1 value obtained 24 hours after the previous morning's dosing. Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liter||Standard Error|Least Squares Mean
6676|NCT02152605|Primary|Change From Baseline in Mean St.George’s Respiratory Questionnaire (SGRQ) Total Score at Day 84|The SGRQ is a disease-specific questionnaire, self-completed by participants(par), used to evaluate the effect of UMEC/VI on health-related quality of life as compared to placebo in par with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Analysis was performed using mixed model repeated measures with covariates of Baseline (scores recorded prior to dosing on Day 1) SGRQ total score, centre group, smoking status, Day, treatment(trt), Day by Baseline interaction and Day by trt interaction, where Day is nominal. Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Score on scale||Standard Error|Least Squares Mean
6677|NCT02152566|Primary|Treatment Efficacy|The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.|During 1 night of Sleep on PSG|Out of 6 patient enrolled, 2 withdrew before participating in the study, 1 did not turn up to his appointment. From 3 participants who took part in the study,1 had a positive diagnosis of Cheyne-Stokes Respiration (CSR). The 1 patient who underwent treatment found the device too uncomfortable therefore no outcome measure data were available.|||||
6678|NCT02152371|Secondary|Rate of Hypoglycemic Events up to 28 Weeks|The rate of total hypoglycemic events any type per 30 days is presented. The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||rate of hypoglycemic events per 30 days||Standard Deviation|Mean
6679|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)||28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
6680|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants achieving target HbA1c of <7.0% at 28 weeks without documented symptomatic hypoglycemia are presented. Documented symptomatic hypoglycemia is defined as any time a participant experienced symptoms and or signs associated with hypoglycemia and had a plasma glucose of <=70 mg/dL.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values||percentage of participants|||Number
6681|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants who achieved a target HbA1c target of <7%, without weight gain and without documented symptomatic hypoglycemia at 28 weeks were analyzed using regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data.Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
6682|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%|Percentage of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had a baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
23682|NCT01706588|Secondary|Amount of Rescue Medication||consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery||||||
6687|NCT02152371|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The percentage of participants with self-reported hypoglycemic events is presented.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
6688|NCT02152371|Secondary|Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events|Cardiovascular (CV) adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the sponsor. Deaths occurring during the study treatment period and nonfatal CV AEs were to be adjudicated. Nonfatal CV events that were to be adjudicated were myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (CVA/stroke), and transient ischemic attack (TIA).|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study.||participants|||Number
6689|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose|Least Square (LS) Means of the insulin dose change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline insulin dose as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who one dose of study drug and had evaluable baseline and post-baseline insulin glargine data.||units (u)||Standard Error|Least Squares Mean
6690|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Body Weight|LS means of the body weight change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline body weight as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data.||kilogram(kg)||Standard Error|Least Squares Mean
6691|NCT02152371|Secondary|Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)|The LS means of the 7-point SMPG change from baseline to primary endpoint at week 28 was measured using a MMRM analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline SMPG as covariate.|Baseline, 28 Weeks|All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline SMPG data.||mg/dL||Standard Error|Least Squares Mean
6692|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)|FSG is a test to determine glucose levels after an overnight fast. LS means FSG change from baseline to primary endpoint at week 28 was calculated using a mixed effects model for repeated measures (MMRM) analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline FSG as covariate.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline FSG data.||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
6693|NCT02152371|Primary|Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post- baseline HbA1c.||percentage of change||Standard Error|Least Squares Mean
6694|NCT02152007|Other Pre-specified|Standardized Photographs|An expert in the disease who is blinded to the study treatment will read the photographs of the callus area taken at each study visit. The reader will assess changes to the calluses based on criteria such as blisters, cracks, small/large size, and red or bloody spots on the callus. Change in calluses will be reported for both the right and left foot.|Each study visit over 39 weeks||||||
6695|NCT02152007|Other Pre-specified|Investigator Assessment of Local Tolerability|Investigator assessment of local tolerability at the application sites on the plantar surfaces will be evaluated by the Investigator according to a 4-point scale (0, 1, 2, or 3; none to severe) with regard to: erythema, pruritis, stinging/burning, and crusting/erosion|Prior to application of study drug and within 15-45 minutes after application of study drug at each visit for 39 weeks|||units on a scale||Standard Deviation|Mean
6696|NCT02152007|Secondary|Daily Assessments Recording in the PC Measurement Diary||Weekly for 39 weeks||||||
6697|NCT02152007|Secondary|Weekly Assessments Recorded in the PC Quality of Life Index|Patient-reported weekly assessment in the PC Quality of Life Index|Weekly for 39 weeks||||||
6698|NCT02152007|Primary|Evaluation of Systemic Absorption Through Measurement of Serum Sirolimus Trough Levels|The primary outcome measure for this Phase 1b safety study is evaluation of system absorption through measurement of serum sirolimus trough levels. The limit of detection of the assay was 2.0 ng/mL.|Two weeks and every 1-2 months for 24 weeks or within 2 weeks after the last dose of study drug|Starting at week 13, visit 4, there were only 14 participants with available data.||participants|||Number
6699|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Food Effect (FE)|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|||% of subject with TEAEs related to SM|||Number
6700|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Multiple Ascending Dose (MAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|No drug-related TEAEs were reported for the dose levels of 50 mg md and 400 mg md.||% of subject with TEAEs related to SM|||Number
6701|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Single Ascending Dose (SAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|||% of subject with TEAEs related to SM|||Number
6702|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6703|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6704|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6705|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6706|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6707|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of participants|||Number
6708|NCT02151786|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
23683|NCT01706588|Secondary|Time to First Use of Rescue Medication.||measured from end of surgery up to 1 week postsurgery||||||
6709|NCT02151786|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
6710|NCT02151773|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.||participants|||Number
6711|NCT02151773|Primary|Number of Participants With Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, adverse drug reactions were assessed as endpoint.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.||participants|||Number
6712|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6713|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6714|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6715|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6716|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6717|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6718|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 8|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6719|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 4|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6742|NCT02150460|Secondary|Total Number of Injections|Total number of injections required to achieve an akinesia score of <4|15 minutes|||injections||Standard Deviation|Mean
6743|NCT02150460|Secondary|Volume of Anaesthetic Drug (ml)|Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery|10 and 15 minutes|||milliliters||Standard Deviation|Mean
6744|NCT02150460|Primary|Pain Score for Local Anaesthetic Injection|Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes|||units on a scale||Standard Deviation|Mean
6720|NCT02151058|Primary|Lobene Stain Index Composite Score at Day 15|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
6721|NCT02150954|Secondary|Neonatal Outcome: Late Fetal Heart Rate Decelerations|Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.|during admission for delivery, up to approximately 4 days|||neonates|||Number
6722|NCT02150954|Secondary|Neonatal Outcome: Placental Abruption|number of participants with placental abruption|during admission for delivery, up to approximately 4 days|||participants|||Number
6723|NCT02150954|Secondary|Neonatal Outcome: Birthweight||at time of birth (0 to 1 hour)|||gram||Standard Deviation|Mean
6724|NCT02150954|Secondary|Incidence of Uterine Hyperstimulation|Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.|during admission for delivery, up to approximately 4 days|||participants|||Number
6725|NCT02150954|Secondary|Time to Foley Expulsion or Removal|Time from foley balloon placement until the expulsion or removal of the foley balloon.|foley bulb placement until removal, up to 10 hours|||hours||Inter-Quartile Range|Median
6726|NCT02150954|Secondary|Time to Active Labor|Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.|during admission for delivery, up to approximately 4 days|||hours||Inter-Quartile Range|Median
6727|NCT02150954|Secondary|Rate of Cesarean Delivery|Number of participants having a cesarean delivery|during admission for delivery, up to approximately 4 days|||participants|||Number
6728|NCT02150954|Primary|Time to Delivery|Time from foley balloon placement until neonate delivery|foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)|||hours||Inter-Quartile Range|Median
6729|NCT02150954|Primary|Time to the Second Stage of Labor|The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.|foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)|||hours||Inter-Quartile Range|Mean
6730|NCT02150499|Secondary|Number and Percentage of Subjects Determined to be Stabilized After Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1||||||
6731|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes||||||
6732|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes||||||
6733|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1||||||
6734|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1||||||
6735|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1|||Number of Discontinuations|||Number
6736|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1|||Number of Serious Adverse Events|||Number
6737|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1|||Number of Adverse Events|||Number
6738|NCT02150460|Primary|Pain Score for Cataract Surgery|Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes|||units on a scale||Standard Deviation|Mean
6739|NCT02150460|Secondary|Duration of Cataract Surgery (Minutes)|Time interval from conjunctival incision to application of eye pad|At the end of surgery|||minutes||Standard Deviation|Mean
6740|NCT02150460|Secondary|Acceptability of the Anaesthetic Block to the Subject|Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye|25 minutes|||participants|||Number
6741|NCT02150460|Secondary|Surgeon Satisfaction Score for Local Anaesthetic Block|Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)|20 minutes|||units on a scale||Full Range|Median
6747|NCT02150460|Primary|Time Taken to Achieve Adequate Akinesia|Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of <4 and was evaluated at 10 and 15 minutes.|10 minutes and 15 minutes|||participants|||Number
6748|NCT02150213|Primary|Incidence of Uterine Endometrial Stromal Sarcomas|Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)||Participants|||Number
6749|NCT02150213|Primary|Incidence of Adrenal Cortical Adenomas|Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full analysis Set: included all patients who signed informed consent to enter the study||Particpants|||Number
6750|NCT02150109|Secondary|Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from subjects WITH and WITHOUT diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour|||Number who strongly agree,agree,neutral|||Number
6751|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.||Blood glucose results within +/- 20%|||Number
6752|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.||Blood glucose results within +/- 20%|||Number
6753|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.||Blood glucose results within +/- 20%|||Number
6754|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.||Blood glucose results within +/- 15%|||Number
6755|NCT02150109|Secondary|Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from persons WITH diabetes (329) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour|||number who strongly agree,agree,neutral|||Number
6756|NCT02150109|Secondary|Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|326 (329-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. One subject had no BG result obtained by study staff. One subject's staff-obtained BG result was not evaluable due to protocol deviation.||Blood glucose results within 15mg/dL/15%|||Number
6798|NCT02147561|Secondary|Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment||Scores on a Scale||Standard Deviation|Mean
6757|NCT02150109|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|318 (329-11) Blood glucose results were analyzed. Eleven (11) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.||Blood glucose results within 15mg/dL/15%|||Number
6758|NCT02150109|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|324 (329-5) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Three subjects did not obtain meter BG result after three attempts.||Blood glucose results within 15mg/dL/15%|||Number
6759|NCT02150044|Secondary|Tube Retention|Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|1 week|||ears|Participants||Number
6760|NCT02150044|Secondary|Procedure Success|Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)|||participants|||Number
6761|NCT02150044|Primary|Ear Outcome Success|Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)|||ears|Participants||Number
6762|NCT02149875|Secondary|Barthel Index Score|Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence|At 11-day and 21-day after therapy|||units on a scale||Standard Deviation|Mean
6763|NCT02149875|Primary|National Institutes of Health Stroke Scale Score|Scores range from 0 to 42, with higher scores indicating increasing severity|At 11-day and 21-day after therapy|||units on a scale||Standard Deviation|Mean
6764|NCT02149342|Other Pre-specified|Clearance of Field Cancerization in Hyperspectral Images|Data not collected|3 months||||||
6765|NCT02149342|Secondary|Pain Assesment (Visual Analog Scale)|Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed.|12 hours|||Mean maximal pain VAS score||Full Range|Mean
6766|NCT02149342|Secondary|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe.|One week|||participants|||Number
6767|NCT02149342|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|Baseline, 3 months|||percentage of lesions in complete respon|Participants|Full Range|Mean
6768|NCT02149342|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|Baseline, 3 months|One patient was excluded from the histological analysis because one biopsied lesion clinically taken as an AK appeared histologically to be seborrheic eczema.||percentage of complete histological clea|Participants|Full Range|Mean
6769|NCT02149303|Primary|Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization|"Proportion of Index events by anatomic location and type are presented. The categories of Unknown and Other presented below correspond to, Unknown: Unknown location of bleeding met the criteria for major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).~Other: Other types of bleeding represent a combined category of all other locations of bleeding whose incidence was <1.7%."|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites||Percentage of events|||Number
6770|NCT02149303|Primary|Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release|Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites||Percentage of participants|||Number
6771|NCT02149303|Primary|Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.|Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites||Percentage of participants|||Number
7310|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort|Surveyed after 1 hour post settling (2 hours) for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).|2 hours post settling|||units on a scale||Standard Deviation|Mean
6772|NCT02148107|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
6773|NCT02148107|Secondary|AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
6774|NCT02148107|Secondary|Cmax (Maximum Measured Concentration of the Analyte Inplasma)|"Cmax (maximum measured concentration of the analyte inplasma).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
6775|NCT02148107|Secondary|AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)|"AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.|||||
6776|NCT02148107|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related Adverse events (AEs)|From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days|Treated set||Percentage of participants|||Number
6777|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 12|||units on a scale||Standard Deviation|Mean
6778|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 8|||units on a scale||Standard Deviation|Mean
6779|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 4|||units on a scale||Standard Deviation|Mean
6780|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 12|||units on a scale||Standard Deviation|Mean
6781|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 8|||units on a scale||Standard Deviation|Mean
6782|NCT02147691|Secondary|Visual Analog Scale (VAS)|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 4|||units on a scale||Standard Deviation|Mean
6783|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 12|||units on a scale||Standard Deviation|Mean
6784|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 8|||units on a scale||Standard Deviation|Mean
6785|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 4|||units on a scale||Standard Deviation|Mean
6786|NCT02147691|Secondary|Lesion Counts||Week 12|||lesions||Standard Deviation|Mean
6787|NCT02147691|Secondary|Lesion Counts||Week 8|||lesions||Standard Deviation|Mean
6788|NCT02147691|Secondary|Lesion Count||Week 4|||lesions||Standard Deviation|Mean
6789|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 12|||units on a scale||Standard Deviation|Mean
6790|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 8|||units on a scale||Standard Deviation|Mean
6791|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 4|||units on a scale||Standard Deviation|Mean
6792|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.|Baseline|||units on a scale||Standard Deviation|Mean
6793|NCT02147691|Secondary|Erythema Visual Analog Scale (VAS) Assessment (Subject)|Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)|Baseline|||units on a scale||Standard Deviation|Mean
6794|NCT02147691|Secondary|Clinician's Erythema Assessment|Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.|Baseline|||units on a scale||Standard Deviation|Mean
6795|NCT02147691|Secondary|Lesion Counts|The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line|Baseline|||lesions||Standard Deviation|Mean
23684|NCT01706588|Secondary|Peak Pain Intensity||measured from end of surgery up to 12 hours postsurgery||||||
6799|NCT02147561|Primary|Percentage of Patients With Adverse Events|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|28 Days|Safety Population: patients enrolled in the study who received study drug||Percentage of Patients|||Number
6800|NCT02147288|Primary|Post-operative Seroma Formation|Quantitative assessment of fluid collection in pre-defined anatomic regions will be performed via ultrasound examination approximately two weeks following removal of drains (either JP or NPWT-associated)|Two weeks following drain removal|Among 21 completers (standard of care group); one outlier was excluded from the analysis; 20 subjects were analyzed. Among 22 completers (experimental group), one outlier and 1 who did not have an ultrasound (i.e., fluid was not measured) were excluded, leaving 20 subjects for analysis.||cm^3||Full Range|Mean
6801|NCT02147093|Primary|Near LogMAR Visual Acuity|Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
6802|NCT02147093|Primary|Distance LogMAR Visual Acuity|Distance time controlled LogMAR Visual Acuity was carried out binocularly, at 4m under 250 cd/m^2 and 2.5 cd/m^2 luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
6803|NCT02146599|Primary|Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery|Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.|Baseline and 1 week|Of the 295 participants who provided data for this analysis (monofocal participants , n=138; accommodating participants, n=34; and multifocal participants, n=123), corrective visual aids (i.e., spectacles, contact lenses) post intraocular lens (IOL) surgery were required by 88 participants.||participants|||Number
6804|NCT02146482|Secondary|Change in Pain in Other Body Parts|The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function.|At the conclusion of each work day for 12 weeks and 8 weeks later||12/2016||||
6805|NCT02146482|Primary|Change in Back Pain|The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to agree or disagree with 24 different statements related to their back pain. The end score is the sum of the agreed statements. The score ranges from 0 (no disability) to 24 (maximum disability).|Baseline (Week 1) and Follow-Up (Week 18)|||units on a scale||Full Range|Median
6806|NCT02146352|Secondary|Technical Success Outcome Measure 2|Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps|30 or 60 Day Post-procedure|Per Protocol||percentage of patients|||Number
6807|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 6|Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
6808|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 5|Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent was removed and tissue at site of stent implant was observed at time of removal||percentage of patients|||Number
6809|NCT02146352|Primary|Safety/Adverse Event Outcome 4|Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent migration/dislodgement could be assessed||percentage of patients|||Number
6810|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 3|Freedom from surgery for access-site related perforation|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
6811|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 2|Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
6812|NCT02146352|Secondary|Clinical Success Outcome Measure|Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days|30 or 60 days post-procedure|Entire patient cohort||percentage of patients|||Number
6813|NCT02146352|Secondary|Technical Success Outcome Measure 1|Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System|Index Procedure|Per Protocol||percentage of patients|||Number
6814|NCT02146352|Secondary|Lumen Patency Outcome Measure|Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.|30 and/or 60 days post-procedure|Per Protocol||percentage of patients|||Number
6815|NCT02146352|Secondary|Stent Retention Outcome Measure|Stent Retention: The stent must remain in place for up to 60 days|30 or 60 days post-procedure|Per Protocol Population||percentage of patients|||Number
6816|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 1|Freedom from access site-related bleeding requiring transfusion|Index procedure through 1-week post-stent removal|Entire patient cohort||percentage of patients|||Number
6817|NCT02146105|Secondary|Change in Biomechanical Outcomes|Participants will be asked to partake in a complete kinematic, kinetic, and electromyographic analysis of gait and static postures using floor-embedded force plates, a 9-camera motion capture system, and a wireless electromyography system. Knee adduction moment (KAM; Nm/kg), normalized electromyography to a percentage of their maximal effort (%MVIC), and muscular co-activation (%) are the variables of interest.|Week 1 and Week 13||||||
6818|NCT02146105|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness is assessed using a sub maximal oxygen consumption cycle ergometer test. Heart rate is monitored using a Polar Heart Rate monitor and the test is terminated upon one of two conditions: a) volitional fatigue, or b) within 10 beats of 85% of the age-predicted maximum heart rate is achieved. Values are recorded in mL/kg/min.|Week 1 and Week 13||||||
6929|NCT02142153|Other Pre-specified|Pharmacokinetics|Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples).|Single dose||||||
6819|NCT02146105|Secondary|Change in Subjective Scales|The Centre of Epidemiologic Studies Depression Scale (19-items), the Athens Insomnia Scale (8-items), and the Perceived Stress Scale (10-items) will be given to the participants to gather information on feelings of depression, sleeping patterns, and perceived stress, respectively.|Week 1 and Week 13||||||
6820|NCT02146105|Secondary|Change in Stair Ascent and Descent|Participants are asked to climb a standard flight of 9 stairs as quickly and safely as possible without compromising safety. Stair ascent and descent are assessed individually. Time to climb the stairs are recorded (in seconds) and averaged over two trials.|Week 1 and Week 13||||||
6821|NCT02146105|Secondary|Change in Timed Up and Go (TUG)|Participants are asked to raise from a standard chair, walk forward 3-metres until an orange cone is reached, walk around the cone, then walk back to the chair and sit down. The test is to be completed as quickly and safely as possible without running. The trial is repeated a second time and the quickest time (in seconds) is recorded.|Week 1 and Week 13||||||
6822|NCT02146105|Secondary|Change in 30-second Chair Stand|Participants are asked to cross their arms over their chest and rise and sit back down in a chair as many times as possible in 30 seconds.|Week 1 and Week 13||||||
6823|NCT02146105|Secondary|Change in Six Minute Walk Test (6MWT)|Participants are asked to walk as far as possible for a total of six minutes at a self-selected pace in an obstruction-free rectangular hallway. Distance traveled is recorded in metres (m).|Week 1 and Week 13||||||
6824|NCT02146105|Primary|Change in Knee Pain|Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.|Week 1 and Week 13||||||
6825|NCT02146105|Primary|Change in Knee Extensor Torque|Knee extensor torque (Nm) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.|Week 1 and Week 13|||Nm||Standard Deviation|Mean
6826|NCT02146001|Secondary|Change in Objectively-monitored Moderate-to-vigorous Physical Activity|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period.|Change from baseline to 12 weeks|||bouted minutes/week||Standard Error|Least Squares Mean
6827|NCT02146001|Secondary|Change in Physical Function (Short Physical Performance Battery [SPPB])|Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best).|Change from baseline to 12 weeks|||points||Standard Error|Mean
6828|NCT02146001|Primary|Change in Objectively Monitored Sedentary Behavior|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.|Change from baseline to 12 weeks|||hours/day||Standard Error|Least Squares Mean
6829|NCT02145754|Primary|Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)|number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field|weekly examination during 9 weeks of cultivating for individual specimen|Each participant provided two skin samples for analysis, one sample was cultivated in MKP, the other in BSK-H media.||culture-positive skin samples|||Number
6830|NCT02145676|Secondary|Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
6831|NCT02145676|Secondary|Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
6832|NCT02145676|Secondary|Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
6833|NCT02145676|Secondary|Change From Baseline in Pain on an 11-Point Scale|The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = “no pain” to 10 = “pain as bad as can be imagined”. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
6867|NCT02144259|Other Pre-specified|Contraceptive Satisfaction|"Satisfaction will be measured in response to the question, How satisfied are you with your current birth control method? This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from Very Good to Very Poor. Good or Very Good responses will be analyzed as having been satisfied with the method."|1 year|||percentage of women satisfied w. method|||Number
6834|NCT02145676|Secondary|Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
6835|NCT02145676|Primary|Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
6836|NCT02145299|Secondary|Angiographic Perforation Classification and Rate|"Evaluated in-hospital. The occurrence of any extravasation of contrast during the procedure (detected by the physician performing the procedure, or preferentially the Angiographic Core Laboratory) will be tabulated according to the standard Type 1-3 classification. Type 1 – Extraluminal crater without contrast extravasation~Type 2 – Perivascular blush without contrast jet extravasation~Type 3 – Contrast jet extravasation through frank (≥1 mm) perforation"|Day of operation|These data were not fully captured and summarized as the study was terminated.|||||
6837|NCT02145299|Secondary|Target Vessel Revascularization|A repeat revascularization procedure (percutaneous or surgical) of the index procedure target vessel. TVR is classified as clinically-driven if the repeat intervention is driven by clinical findings (ischemic symptoms).|30 days post operation|||percentage of participants|||Number
6838|NCT02145299|Secondary|Ankle-brachial Index (ABI)|The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm|baseline to 30 days post operation|||ratio||Standard Deviation|Mean
6839|NCT02145299|Secondary|Target Lesion Revascularization|Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis.|30 days post operation|||percentage of participants|||Number
6840|NCT02145299|Secondary|Index Limb Amputation|Need for limb amputation|Day of Operation through 30 days post operation|||participants|||Number
6841|NCT02145299|Secondary|Walking Capacity|"Change in walking capacity from baseline to 30 days, measured by the Walking Impairment Questionnaire. The questionaire is a subjective measure of patient-perceived walking performance developed for individuals with peripheral arterial disease. Used to evaluate the change in walking capacity study endpoint."|Baseline and 30 days post operation|These data were not fully captured and summarized as the study was terminated.|||||
6842|NCT02145299|Secondary|Symptomatic Improvement|Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days|Baseline, and 30 days post operation|||percentage of participants|||Number
6843|NCT02145299|Secondary|Clinical Success|Clinical Success defined as procedure success in the absence of in-hospital all-cause death, index limb amputation above the ankle, and TLR.|Day of operation|These data were not fully captured and summarized as the study was terminated.|||||
6844|NCT02145299|Secondary|Procedural Success|Procedural success, defined as technical success and (1) residual stenosis <50% in the treated segment (2) and improved distal flow by angiography following the procedure|Day of operation|Due to early study termination for reason unrelated to safety, rather enrollment challenges, part the Procedural Success definition required % residual stenosis which was going to be a Core Laboratory assessment to eliminate bias and maintain consistency in the analysis. With only 8 subjects enrolled, laboratory analysis was not undertaken.|||||
6845|NCT02145299|Primary|In-hospital Safety|In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR)|Operation through 30 day follow up|||percentage of participants|||Number
6846|NCT02145299|Primary|Technical Success|Technical success, defined as the ability to facilitate complete intraluminal crossing of a CTO into the true distal lumen with a TruePath or a CROSSER device and/or any subsequent conventional guidewire, as confirmed by IVUS imaging|Day of operation|||percentage of participants|||Number
6847|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
6848|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
6849|NCT02145156|Primary|Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
16178|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Concentration||Baseline, Week 8|||mmol/L||95% Confidence Interval|Least Squares Mean
6850|NCT02145156|Primary|Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.||participants|||Number
6851|NCT02145156|Primary|Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.||participants|||Number
6852|NCT02145156|Primary|Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.||participants|||Number
6853|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
6854|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
6855|NCT02145156|Primary|Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.||participants|||Number
6856|NCT02145156|Primary|Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.||participants|||Number
6857|NCT02145156|Primary|Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.||participants|||Number
6858|NCT02145156|Primary|Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.||participants|||Number
6859|NCT02144337|Primary|Feasibility: Number of Participants With Adverse Events|Number of participants experiencing and/or reporting adverse events.|Participants were followed from baseline to research completion|||number of participants|||Number
6860|NCT02144337|Secondary|Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)||0 months (baseline) and 6 months (follow-up)||||||
6861|NCT02144337|Secondary|Change in Clinical Outcome Measures (Hba1c, Height, Weight)|Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up.|0 months (baseline) and 6 months (follow-up)||||||
6862|NCT02144337|Secondary|Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)||0 months (baseline) and 6 months (follow-up)||||||
6863|NCT02144337|Secondary|Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self‐Perceptions of Adequacy in and Predilection for Physical Activity)||0 months (baseline) and 6 months (follow-up)||||||
6864|NCT02144337|Primary|Feasibility: Rate of Adherence to the Intervention|Attendance at physical activity sessions and completion of activity diary Intervention group only as the Control group were not exposed to any intervention.|Participants were monitored for the duration of the STAK programme (6 weeks)|||percentage of the intervention group|||Number
6865|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T3|Response rate at T3|||Number of participants|||Number
6866|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T2|Response rate at T2|||number of participants|||Number
6868|NCT02144259|Secondary|Pregnancy Rate|The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.|1 year|||number of pregnancies|||Number
18964|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 7 to 9 months post-vaccination||||||
6873|NCT02144220|Primary|Change in Quality of Life as Measured by the PDQ-39 Assessment Tool|The impact on Quality of life (QoL) as measured by the change in PDQ-39 score from baseline to 6 months. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality over the last month. 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.|6 months|||units on a scale||95% Confidence Interval|Number
6874|NCT02144220|Primary|Feasibility|The percent of telemedicine visits completed as scheduled. (Goal >80%)|6 months|||percentage of visits|||Number
6875|NCT02143947|Secondary|Maximum First Ray Complex Plantarflexion During Stance|The first ray complex plantarflexion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum first ray complex plantarflexion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||Degrees||Standard Deviation|Mean
6876|NCT02143947|Secondary|Maximum Forefoot Inversion During Stance|The forefoot inversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum forefoot inversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||Degrees||Standard Deviation|Mean
6877|NCT02143947|Secondary|Maximum Electromyographic Activity of Lower Leg Muscles|The maximum electromyographic activity of the lower leg muscles is with respect to the barefoot condition. The electromyographic activity of the lower extremity muscles were recorded during the stance phase of walking while barefoot and while wearing their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization). All electromyographic measurements were taken at the 5 week time point. The peak electromyographic activity during the stance phase of barefoot walking was determined. The electromyographic activity during the orthotic condition was amplitude normalized to the barefoot condition by dividing the electromyographic activity of the orthotic condition by the peak barefoot electromyographic activity and multiplying by 100. The stance phase of walking was then divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the peak amplitude normalized electromyographic activity of each subphase det|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||percentage of maximum electromyo actvity||Standard Deviation|Mean
6878|NCT02143947|Primary|Maximum Rearfoot Eversion Motion During Stance|The rearfoot eversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum rearfoot eversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.||Degrees||Standard Deviation|Mean
6879|NCT02143583|Secondary|Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season|"The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms).~For each question the answer is quoted from 0: no troubled to 6: extremely troubled; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case"|between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : patients having received at least 4 injections of AllerT or placebo in AN004T||units on a scale||Standard Deviation|Mean
6880|NCT02143583|Primary|Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season|"The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3).~The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows:~0 = no medication~= subject took topical antihistamine~= subject took oral antihistamine~= subject took oral corticosteroids"|from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : participants having received at least 4 injections of AllerT or placebo in AN004T||units on a scale||Standard Deviation|Mean
6881|NCT02142712|Other Pre-specified|CT or MRI of Head Without Contrast|MRI of head or CT head done as part of your follow up care at 3 months. This will give us the information about the effect of dextromethorphan effect on the final brain damage from stroke.|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.|||||
6896|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
18965|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 9 months post-vaccination||||||
6882|NCT02142712|Primary|Barthel Index|"It is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. It yields a score of 0-20.~The ten variables addressed in the Barthel scale are:~presence or absence of fecal incontinence~presence or absence of urinary incontinence~help needed with grooming~help needed with toilet use~help needed with feeding~help needed with transfers (e.g. from chair to bed)~help needed with walking~help needed with dressing~help needed with climbing stairs~help needed with bathing"|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.|||||
6883|NCT02142712|Primary|Glasgow Coma Scale (GCS)|Glasgow Coma Scale (GCS) is assessed by physical neurological examination of the subject by a qualified neurologist. GSC is a common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. The initial score correlates with the severity of brain injury and prognosis. It estimates Coma severity based on Eye (4), Verbal (5), and Motor (6) criteria with the following total score of between 3 (indicating deep unconsciousness) and 15 (indicating no issues).|Baseline|Data was collected only for the baseline visit, since the participants did not come back for follow-ups.||Glasgow Coma Scale|||Number
6884|NCT02142712|Primary|National Institutes of Health Stroke Severity (NIHSS) Scale|NIHSS is a tool used by healthcare providers to objectively quantify the degree of impairment caused by a stroke. It is composed of 11 items. Each item scores a specific ability between a score of 0-4. Usually, for each item, a score of 0 indicates normal function in that specific ability, while a higher score indicates some level of impairment. The individual scores from each item are added together to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|Baseline|NIHSS data was only collected for the baseline visit, since the participants did not come back for follow-ups.||NIHSS scale|||Number
6885|NCT02142712|Primary|Modified Rankin Score|"The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke.It is one of the most widely used clinical outcome measure for stroke clinical trials. The score is given according to following scale.~0- No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|8 days and 3 months from the baseline|The data was not collected since the participants did not come back for follow-ups.|||||
6886|NCT02141867|Secondary|Duration of Critical Care Stay||Upto 30 days|||Days||Inter-Quartile Range|Median
6887|NCT02141867|Secondary|Admission to Critical Care After Surgery||Upto 30 days|||participants|||Number
6888|NCT02141867|Secondary|Duration of Hospital Stay||Upto 30 days|||Days||Inter-Quartile Range|Median
6889|NCT02141867|Primary|Mortality|In hospital mortality|Upto 30 days|||participants|||Number
6890|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6891|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||degrees|Participants|Standard Deviation|Mean
6892|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||degrees|Participants|Standard Deviation|Mean
6893|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6894|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6895|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6897|NCT02142361|Primary|Clinicians Assessment Corneal Coverage-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6898|NCT02142361|Primary|Clinician's Assessment Corneal Coverage-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6899|NCT02142361|Primary|Clinician's Assessment Lens Centration- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6900|NCT02142361|Primary|Clinician's Assessment Lens Centration-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6901|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6902|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6903|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6904|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6905|NCT02142361|Primary|Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||LogMAR||Standard Deviation|Mean
6906|NCT02142361|Primary|Clinician's Objective Assessment Monocular High Contrast Distance Visual|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||LogMAR||Standard Deviation|Mean
6907|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Overall|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6908|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Lens Fit|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6909|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Vision|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
18966|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 7 to 9 months post-vaccination||||||
6910|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Handling|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm.~Sum of percentage for the Study Lens Arm=101 as, Category title-  Somewhat dissatisfied- 1.7 was rounded to 2."||percentage of eyes|Participants||Number
6911|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."||percentage of eyes|Participants||Number
6912|NCT02142361|Primary|Participant's Subjective Rating for Lens Pair Preference|Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.|1 week|"All 60 paticipants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm. Vision category data for one participant was not collected."||Percentage of eyes|Participants||Number
6913|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at End of Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6914|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6915|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6916|NCT02142361|Primary|Participant's Subjective Rating for Night Vision Quality|Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6917|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality End of the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6918|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6919|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6920|NCT02142361|Primary|Participant's Subjective Rating for Overall Vision Satisfaction|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6921|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Fit Stability|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6922|NCT02142361|Primary|Participant's Subjective Rating for Lens Handling - Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6923|NCT02142361|Primary|Participant's Subjective Rating for Overall Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6924|NCT02142361|Primary|Participant's Subjective Rating for Dryness Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6925|NCT02142361|Primary|Participant's Subjective Rating for Dryness During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6926|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6927|NCT02142361|Primary|Participant's Subjective Rating for Lens Comfort Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
6928|NCT02142361|Primary|Participant's Subjective Rating for Lens Initial Comfort|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week|||units on a scale||Standard Deviation|Mean
7939|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Placebo|Duration of anesthesia of patients receiving intranasal placebo Duration from anesthesia intubation to anesthesia ending|1 day|||minutes|||Number
6932|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
6933|NCT02141997|Secondary|Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score from 2.8 to ≤ 10 at Week 12. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
6934|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
6935|NCT02141997|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. LDA is defined as a DAS28 (hsCRP) score from 2.6 to < 3.2 at Week 12. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
6936|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12|Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
6937|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12|Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value||percentage of participants|||Number
6938|NCT02141997|Secondary|Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. A negative change from baseline represents improvement. n=the number of participants with evaluable data at each time point. LOCF was used (only post-baseline values were carried forward).|Baseline, Weeks 2, 4, 6, 8, and 12|Subjects in the FAS with a baseline value and at least 1 post-baseline value||units on a scale||95% Confidence Interval|Least Squares Mean
6939|NCT02141997|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire – Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Full analysis set (FAS) defined as all randomized participants with at least 1 dose of study drug.||percentage of participants|||Number
6940|NCT02141633|Secondary|Echocardiogram|to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers|MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers|||ΔMPAP (mmHg)||Standard Error|Mean
6941|NCT02141633|Primary|Airway Blood Flow|compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers|before and 15 minutes after albuterol inhalation|||ΔQaw (ul/min/ml)||Standard Error|Mean
6942|NCT02141620|Secondary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||degrees Fahrenheit||Standard Error|Mean
8712|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>2 to <= 5 Years)|Artefenomel concentration on Day 7 in African Patients >2 to <= 5 years. All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
6943|NCT02141620|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||beats per minute||Standard Error|Mean
6944|NCT02141620|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
6945|NCT02141620|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||mm Hg||Standard Error|Mean
6946|NCT02141620|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6947|NCT02141620|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6948|NCT02141620|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6949|NCT02141620|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6950|NCT02141620|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6951|NCT02141620|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6952|NCT02141620|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6953|NCT02141620|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6954|NCT02141620|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
7061|NCT02138097|Secondary|Persistence at 12 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in United Healthcare cohort||Percentage of participants|||Number
6955|NCT02141620|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6956|NCT02141620|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6957|NCT02141620|Secondary|"Peak Ratings of Nauseous on the Visual Analog Scale"|"Subjects rated their feelings of Nauseous on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6958|NCT02141620|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6959|NCT02141620|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6960|NCT02141620|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6961|NCT02141620|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6962|NCT02141620|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6963|NCT02141620|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6964|NCT02141620|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6965|NCT02141620|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
7032|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)|Skin temperature(Ts) was measured at four different points within the cutaneous innervation areas of the musculocutaneous(lateral skin of forearm), ulnar(hypothenar region), radial (thumb-index web) and median(thenar) Specific points were located with skin marker to provide consistency of measurement.|baseline, 30 min after specific nerve block, 30 min after brachial plexus block|||℃||Standard Deviation|Mean
6966|NCT02141620|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6967|NCT02141620|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.|||units on a scale||Standard Error|Mean
6968|NCT02141620|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.|||Number of Cocaine Choices||Standard Deviation|Mean
6969|NCT02141516|Primary|Number Of Subjects With Unsolicited Adverse Events (AEs).|Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).|At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)|Analysis was done on the Unsolicited Safety Set (all subjects in the exposed set with postvaccination unsolicited AE records).||participants|||Number
6970|NCT02141516|Secondary|Number of Subjects Reporting Solicited Local and Systemic AEs.|Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.|From Day 1 until Day 7 after any vaccination.|Analysis was done on Solicited Safety Set (all subjects in the exposed set with any solicited AE data).||participants|||Number
6971|NCT02141516|Primary|Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Percentage of Subjects||95% Confidence Interval|Number
6972|NCT02141516|Primary|ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
6973|NCT02141516|Primary|Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||IU/mL||95% Confidence Interval|Geometric Mean
6974|NCT02141516|Primary|Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Percentage of Subjects||95% Confidence Interval|Number
6975|NCT02141516|Primary|Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
6976|NCT02141516|Primary|Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
6977|NCT02141516|Primary|Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set||Percentage of Subjects||95% Confidence Interval|Number
7033|NCT02139982|Primary|Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)|"These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX), resistance index (RI), and pulsatility index (PI),The cross-sectional area of the artery imaging.Blood flow (BF) = TAMAX× CSA×60s.~Relative ratio of hemodymanic parameter=30 min after brachial plexus block divide by baseline"|baseline, 30 min after brachial plexus block|||ratio||Inter-Quartile Range|Median
11612|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-1 Beta|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.|Baseline and 3 months||||||
6978|NCT02141516|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine)|Analysis was done on Full Analysis Set (all subjects in the enrolled set who: received a study vaccination and provided an evaluable serum sample at 1 month after the second dose of rMenB+OMV NZ, with assay result available for at least one of the serogroup B indicator strains or M10713 strain or ELISA).||Percentage of Subjects||95% Confidence Interval|Number
6979|NCT02141217|Secondary|Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.||Scores on a scale||95% Confidence Interval|Least Squares Mean
6980|NCT02141217|Secondary|Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.||Scores on a scale||95% Confidence Interval|Least Squares Mean
6981|NCT02141217|Secondary|Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5|CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but ‘no change’ or ‘worsening from BL’ in other s/sx (like increased leucocyte count/tooth mobility), the inv’s opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with ‘no change’ or ‘worsening from BL’ in these other s/sx were considered as cl failures and termed ‘Without Considering Cl Jdg of Inv’, even though main s/sx are 'cured' or 'improved'. .|Day 5|ITT-E Population||Participants|||Number
6982|NCT02141217|Secondary|Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5|ITT-E Population. Only the participants with Day 5 assessments were considered for analysis.||Participants|||Number
6983|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-to-Treat (ITT) Population (randomized as per treatment allocation): all randomized participants who received at least one dose of study medication. If the post-Baseline assessment of clinical success response was missing then “Clinical Success” is considered as “No” i.e. the participant was treated as “Clinical Failure”.||Percentage of participants|||Number
6984|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-To-Treat-Efficacy (ITT-E) Population: all participants in the ITT participants who had at least one post-Baseline assessment of clinical success response (clinical response based on assessment on odontogenic infection and VAS Score).||Percentage of participants|||Number
7062|NCT02138097|Secondary|Persistence at 6 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in United Healthcare cohort||Percentage of participants|||Number
6985|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Per-Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (defined as all randomized participants who received at least one dose of study medication) who were without major protocol violations and had end of treatment clinical response assessment available.||Percentage of participants|||Number
6986|NCT02140957|Secondary|Current Nighttime Bottle Use|Current nighttime bottle use.|2 years|||participants|||Number
6987|NCT02140957|Secondary|Current Bottle Use|Current daytime bottle use.|2 years|||participants|||Number
6988|NCT02140957|Primary|Change in Iron Depletion|Iron depletion (serum ferritin < 10 μg/L).|Baseline, 2 years|||percentage of participants|||Number
6989|NCT02140788|Secondary|Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items|The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization.|baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
6990|NCT02140788|Secondary|Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
6991|NCT02140788|Secondary|Changes in C-reactive Protein and Sedimentation Rates||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
6992|NCT02140788|Secondary|Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
6993|NCT02140788|Primary|Change in Weight||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.|||||
6994|NCT02140645|Primary|Binary EMR Characteristic: Pancreatitis|"The missing EMR characteristic pancreatitis defined as participants with any note of prior pancreatitis.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic pancreatitis was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
6995|NCT02140645|Primary|Binary EMR Characteristic: Retinopathy|"The missing EMR characteristic retinopathy defined as participants with any note of diabetic retinopathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic retinopathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
6996|NCT02140645|Primary|Binary EMR Characteristic: Nephropathy|"The missing EMR characteristic nephropathy defined as participants with any note of diabetic nephropathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic nephropathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
6997|NCT02140645|Primary|Binary EMR Characteristic: Neuropathy|"The missing EMR characteristic neuropathy defined as participants with any note of diabetic neuropathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic neuropathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
6998|NCT02140645|Primary|Missing EMR Characteristic: Diastolic BP|"The missing EMR characteristic diastolic BP defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic diastolic BP was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||mmHg||Standard Deviation|Mean
18967|NCT01797029|Secondary|Safety Profile of LAIV: Immediate Reactions||30 minutes post-vaccination|||participants|||Number
6999|NCT02140645|Primary|Missing EMR Characteristic: Systolic BP (Blood Pressure)|"The missing EMR characteristic systolic BP defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic systolic BP was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||mmHg||Standard Deviation|Mean
7000|NCT02140645|Primary|Missing EMR Characteristic: Total Cholesterol|"The missing EMR characteristic total cholesterol defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic total cholesterol was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||mg/dl||Standard Deviation|Mean
7001|NCT02140645|Primary|Missing EMR Characteristic: eGFR (Glomerular Filtration Rate)|"The missing EMR characteristic eGFR defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic eGFR was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||ml/min per 1.73 m^2||Standard Deviation|Mean
7002|NCT02140645|Primary|Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin))|"The missing EMR characteristic HbA1c defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic HbA1c was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage||Standard Deviation|Mean
7003|NCT02140645|Primary|Missing EMR Characteristic: BMI (Continuous)|"The missing EMR characteristic BMI is BMI value. Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics BMI as continuous outcomes.~The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Kg/m^2||Standard Deviation|Mean
7004|NCT02140645|Primary|Missing EMR Characteristic: BMI (Body Mass Index)|"The missing EMR characteristic BMI defined as not obese, overweight, obese, severe obesity.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic BMI was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
7005|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes (Continuous)|"The missing EMR characteristic duration of diabetes defined as starting year/starting age of diabetes.~Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics duration of diabetes as continuous outcomes.~The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Months||Standard Deviation|Mean
7006|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes|"The missing EMR characteristic duration of diabetes defined as >7, 5-6, 3-5, 1-3, <1 (in years) in duration.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic duration of diabetes was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
7034|NCT02139982|Primary|Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX),and was measured by Pulsed-wave Doppler(PWD) ultrasound.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)|||cm/s||Standard Deviation|Mean
7035|NCT02139943|Primary|Percentage of Participants With Adverse Events||Up to 22 Weeks|Safety Analysis Set included all randomized participants who took at least 1 dose of double-blind study drug.||percentage of participants|||Number
7007|NCT02140645|Primary|Missing EMR (Electronic Medical Record) Characteristic: Smoking|"The missing EMR characteristic smoking defined as current, unknown, versus past/never smoker.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic smoking was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.||Percentage of participants|||Number
7008|NCT02140372|Secondary|Platelet Adhesion: 2 Hours||2 hours|||percentage of adhered platelets||Inter-Quartile Range|Median
7009|NCT02140372|Secondary|Platelet Adhesion: Baseline||Baseline|||percentage of adhered platelets||Inter-Quartile Range|Median
7010|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine epinephrine|2 hours|||percentage of max platelet aggregation||Inter-Quartile Range|Median
7011|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine epinephrine|baseline|||percentage of max platelet aggregation||Inter-Quartile Range|Median
7012|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine diphosphate|2 hours|||percentage of max platelet aggregation||Inter-Quartile Range|Median
7013|NCT02140372|Primary|Monocyte Platelet Aggregate: 2 Hours||2 Hours|||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
7014|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine diphosphate|Baseline|||percentage of max platelet aggregation||Inter-Quartile Range|Median
7015|NCT02140372|Primary|Monocyte Platelet Aggregate: Baseline||Baseline|||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
7016|NCT02140164|Secondary|Number of Severe Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.||adverse events|||Number
7017|NCT02140164|Secondary|Number of Non-ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.||adverse events|||Number
7018|NCT02140164|Secondary|Number of Ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.||adverse events|||Number
7019|NCT02140164|Secondary|Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline||Baseline and 12 Months|||eyes|eyes||Number
7020|NCT02140164|Secondary|Changes in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values||12 Months||06/2017||||
7021|NCT02140164|Secondary|Changes in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values||6 Months||06/2017||||
7022|NCT02140164|Secondary|Changes in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values||12 Months||06/2017||||
7023|NCT02140164|Secondary|Changes in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values||6 Months||06/2017||||
7024|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported, as patients had non-recordable ERGs. Therefore, changes could not be measured.|12 Months||||||
7025|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported, as patients had non-recordable ERGs. Therefore, changes could not be measured.|6 Months||||||
7026|NCT02140164|Secondary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to Pre-treatment Values|This secondary endpoint of the study was change in central subfield thickness (CST) at 12 months compared to pre-treatment values. Pre-treatment measurements were analyzed to measure the natural variability of the CME.|12 Months|||microns||Standard Deviation|Mean
7027|NCT02140164|Primary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to Pre-treatment Values|The primary endpoint of the study was change in central subfield thickness (CST) at 6 months compared to pre-treatment values. Pre-treatment measurements were analyzed to measure the natural variability of the CME.|6 Months|Participants receiving investigational product (IP) at the Month 6 visit were included in the primary efficacy analysis.||microns||Standard Deviation|Mean
7028|NCT02140060|Primary|Mean IOP at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.|Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM|"This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, n is the number of subjects with non-missing values at the specific time point for each arm, respectively."||mmHg||Standard Error|Mean
7029|NCT02139982|Primary|Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|The cross-sectional area(CSA, cm2) of Radial/ulnar Artery was assessed with B-mode imaging. Probe was kept perpendicular to the long axis of the artery to obtain the largest oval arterial section. The image at end diastole was chosen and measured with the cine loop.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)|||cm^2||Standard Deviation|Mean
7030|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)|Skin temperature was measured at the thenar. change= 30min after brachial plexus block minus baseline|Baseline,30 min after brachial plexus block|||℃||Standard Deviation|Mean
7031|NCT02139982|Secondary|Success of Brachial Plexus Block ( Phase 2)|Success of Brachial Plexus Block(BPB) was defined as the absence of sensation to in all innervation areas of above four nerves (musculocutaneous, ulnar, radial, and median nerves) 30min. after the BPB and no pain during the surgery.|30 min after brachial plexus block|||participants|||Number
7036|NCT02139943|Primary|Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight|Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.|Week 18|Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug. 'N (Number of Participants Analyzed)’ signifies participants who were evaluable for this outcome measure.||percentage of participants|||Number
7037|NCT02139878|Secondary|Glucose|Plasma blood glucose concentrations|Up to 4 weeks|||mmol/L||Standard Error|Mean
7038|NCT02139878|Primary|Blood Pressure|Systolic blood pressure|Up to 4 weeks|||mm Hg||Standard Error|Mean
7039|NCT02139228|Secondary|Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as the percentages of subjects with Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS) (i.e. All subjects in the All Enrolled Set with no reportable protocol deviations).||Percentage of subjects||95% Confidence Interval|Number
7040|NCT02139228|Primary|Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS)-All subjects in the All Enrolled Set with no reportable protocol deviations.||Concentration in μg/mL||95% Confidence Interval|Geometric Mean
7041|NCT02139046|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
7042|NCT02139046|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.||percentage of participants|||Number
7043|NCT02139046|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
7044|NCT02138747|Secondary|Number of Participants With Adverse Events|Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug.|Baseline to EOT (Week 18) and follow up (Week 20)|Safety Analysis Set consisted of all participants who received at least 1 dose of double-blind study drug (SAF).||Participants|||Number
7045|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|"Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit.~Last observation carried forward imputation (LOCF) was utilized."||Micturitions||Standard Error|Least Squares Mean
7046|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|Full Analysis Set Incontinence (FAS I) consisted of all participants in the FAS who had at least 1 incontinence episode in the baseline 3-day micturition diary and at least 1 postbaseline diary during period 1.Last observation carried forward imputation (LOCF) was utilized.||Incontinence Episodes||Standard Error|Least Squares Mean
7047|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication|Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
7048|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication|Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
7060|NCT02138097|Secondary|Persistence at 3 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in MarketScan cohort||Percentage of participants|||Number
7128|NCT02137785|Primary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|ITT||participants|||Number
7049|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication|Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
7050|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB|Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Unit on a Scale||Standard Error|Mean
7051|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant’s Fulfillment of OAB Medication Expectations|The final item score for overall assessment of patient’s fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
7052|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control|Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
7053|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control|OAB control was scored from 0 to 100, with higher scores indicating better OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
7054|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.|Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Mean
7055|NCT02138747|Secondary|Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.|"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (“strong preference for period 1,” “mild preference for period 1,” “no preference,” “mild preference for period 2,” “strong preference for period 2”). Participants who selected either a “mild preference” or “strong preference” were considered as having a preference for a specific study drug and participants who selected “no preference” were considered as having no preference for one study drug over the other study drug."|Week 18 (End of Period 2)|Full Analysis Set (FAS-PNP [Preference/No Preference]) consisted of all randomized participant who took at least 14 days of double-blind study drug in each treatment period and had filled out the patient preference form.||Percentage of participants|||Number
7056|NCT02138747|Primary|Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)|The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).|Week 8 (End of Period 1) and Week 18 (End of Period 2)|The Full Analysis Set (FAS) comprised of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.||Units on a Scale||Standard Error|Least Squares Mean
7057|NCT02138461|Primary|Tolerability of Medications as Measured by the COMTOL Validated Instrument|Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.|at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study|||percentage of patients|||Number
7058|NCT02138097|Secondary|Persistence at 12 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in MarketScan cohort||Percentage of participants|||Number
7059|NCT02138097|Secondary|Persistence at 6 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in MarketScan cohort||Percentage of participants|||Number
7063|NCT02138097|Secondary|Persistence at 3 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in United Healthcare cohort||Percentage of participants|||Number
7064|NCT02138097|Secondary|Proportion of Days Covered for MarketScan Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in MarketScan cohort||days covered||Standard Deviation|Mean
7065|NCT02138097|Secondary|Proportion of Days Covered for United Healthcare Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in United Healthcare cohort||days covered||Standard Deviation|Mean
7066|NCT02138097|Secondary|Treatment Discontinuation for Marketscan Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in Marketscan cohort||participants/1000 participant years|||Number
7067|NCT02138097|Secondary|Treatment Discontinuation for United Healthcare Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in United Healthcare cohort||participants/1000 participant years|||Number
7068|NCT02138097|Primary|Subsequent Insulin Initiation for MarketScan Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in MarketScan cohort||participants/1000 participant years|||Number
7069|NCT02138097|Primary|Subsequent Insulin Initiation for United Healthcare Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in United Healthcare cohort||participants/1000 participant years|||Number
7070|NCT02138097|Primary|Treatment Augmentation for MarketScan Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in MarketScan cohort||participants/1000 participant years|||Number
7071|NCT02138097|Primary|Treatment Augmentation for United Healthcare Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in United Healthcare cohort||participants/1000 participant years|||Number
7072|NCT02138097|Primary|Treatment Switching for MarketScan Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in MarketScan cohort||participants/1000 participant years|||Number
7073|NCT02138097|Primary|Treatment Switching for United Healthcare Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in United Healthcare cohort||participants/1000 participant years|||Number
7074|NCT02138097|Primary|Proportion of Initiators for MarketScan Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in MarketScan cohort||Percentage of participants|||Number
7075|NCT02138097|Primary|Proportion of Initiators for United Healthcare Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in the United Healthcare cohort||Percentage of participants|||Number
7076|NCT02138006|Secondary|Morbidity of Cardiovascular Complications|Morbidity of: coronary heart disease, stroke and renal failure|Up to 28 years|||participants|||Number
7077|NCT02138006|Primary|Cardiovascular Mortality|All cause mortality and composite mortality from myocardial infarction, stroke and renal failure|Up to 28 years|||participants|||Number
7078|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT||participants|||Number
7079|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT||participants|||Number
7080|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|4 Weeks after PDT #1|ITT||participants|||Number
7081|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|2 Weeks after PDT #1|ITT||participants|||Number
7129|NCT02137603|Secondary|Thirty Day Complication Rate|Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation|Thirty days|||participants|||Number
7082|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|ITT||participants|||Number
7083|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT||participants|||Number
7084|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|ITT||participants|||Number
7085|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks after PDT #1|ITT||participants|||Number
7086|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|4 Weeks after PDT #1|ITT||participants|||Number
7087|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks after PDT #1|ITT||participants|||Number
7088|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|ITT||participants|||Number
7089|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT||participants|||Number
7090|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT||participants|||Number
7091|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT||participants|||Number
7092|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|4 Weeks after PDT #1|ITT||participants|||Number
7093|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT||ITT|||Number
7094|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 Hours after PDT #1|ITT||participants|||Number
7095|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT||participants|||Number
7096|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT||participants|||Number
7097|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT||participants|||Number
7130|NCT02137603|Primary|Post Operative Length of Stay||Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours|||Hours||Standard Deviation|Mean
7131|NCT02137512|Other Pre-specified|Reported Adverse Events|Reported adverse events during the 5-month extension phase.|Extension phase 5-month period||08/2016||||
7098|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT||participants|||Number
7099|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT||participants|||Number
7100|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|4 Weeks after PDT #1|ITT||participants|||Number
7101|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 weeks after PDT #1|ITT||participants|||Number
7102|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|ITT||participants|||Number
7103|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1|ITT||participants|||Number
7104|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT||participants|||Number
7105|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT||participants|||Number
7106|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT||participants|||Number
7107|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|4 Weeks after PDT #1|ITT||participants|||Number
7108|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT||participants|||Number
7109|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|ITT||participants|||Number
7110|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1|ITT||participants|||Number
7111|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT||participants|||Number
7112|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT||participants|||Number
7113|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT||participants|||Number
7114|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT||participants|||Number
7115|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT||participants|||Number
7116|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT||participants|||Number
7117|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|ITT||participants|||Number
7118|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT||participants|||Number
7119|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT||participants|||Number
7120|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT||participants|||Number
7121|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT||participants|||Number
7122|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT||participants|||Number
7123|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT||participants|||Number
7124|NCT02137785|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|ITT||participants|||Number
7125|NCT02137785|Secondary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8|ITT||participants|||Number
7126|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 8|ITT using observed data only||percentage of baseline lesions cleared||Standard Deviation|Mean
7127|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 12|ITT using observed data only||percentage of baseline lesions cleared||Standard Deviation|Mean
7132|NCT02137512|Other Pre-specified|Episodes of Severe Hypoglycemia Events|Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|Extension phase 5-month period||08/2016||||
7133|NCT02137512|Other Pre-specified|Episodes of DKA Events|Episodes of DKA events that occurred during the 5-month extension phase.|Extension phase 5-month period||08/2016||||
7134|NCT02137512|Other Pre-specified|Glucose Coefficient of Variation (CV)|Glucose coefficient of variation in CGM measured glucose values over the course of the 5-month extension phase.|Extension phase 5-month period||08/2016||||
7135|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >300 mg/dL|Percentage of CGM measured glucose values >300 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
7136|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >250 mg/dL|Percentage of CGM measured glucose values >250 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
7137|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >180 mg/dL|Percentage of CGM measured glucose values >180 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
7138|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values 70-180 mg/dL|Percentage of CGM measured glucose values 70-180 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
7139|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <70 mg/dL|Percentage of CGM measured glucose values <70 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
7140|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <60 mg/dL|Percentage of CGM measured glucose values <60 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
7141|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <50 mg/dL|Percentage of CGM measured glucose values <50 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||08/2016||||
7142|NCT02137512|Other Pre-specified|Mean CGM Sensor Glucose|Mean glucose during study system use at home during the extension phase in day+night closed-loop configuration|Extension phase 5-month period||08/2016||||
7143|NCT02137512|Other Pre-specified|Change in HbA1c|Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase.|Extension phase 5-month period||08/2016||||
7144|NCT02137512|Secondary|High Blood Glucose Index (HBGI)|High blood glucose index (HBGI) in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period. HBGI is a metric specifically designed to calculate the risk for hyperglycemia as reflected by blood glucose data. The HBGI is a non-negative quantity that increases when the number and/or extent of high blood glucose readings increases.|2-weeks|One participant was excluded due to missing baseline CGM data.||[ln(mg/dL)]^1.084||Inter-Quartile Range|Median
7145|NCT02137512|Secondary|Area Under the Curve (AUC) Glucose >180 mg/dL|Area under the Curve (AUC) glucose >180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||mg/dL * hours||Inter-Quartile Range|Median
7146|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values >180 mg/dL|Percentage of time CGM measured glucose values >180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage of sensor hours||Inter-Quartile Range|Median
7147|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values >250 mg/dL|Percentage of time CGM measured glucose values >250 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage of sensor hours||Inter-Quartile Range|Median
7148|NCT02137512|Secondary|Low Blood Glucose Index (LBGI)|Low blood glucose index (LBGI) in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period. LBGI is a metric specifically designed to calculate the risk for hypoglycemia as reflected by blood glucose data. The LBGI is a non-negative quantity that increases when the number and/or extent of low blood glucose readings increases.|2-weeks|One participant was excluded due to missing baseline CGM data.||[ln(mg/dL)]^1.084||Inter-Quartile Range|Median
7149|NCT02137512|Secondary|Area Under the Curve (AUC) Under 180 mg/dL|Area under the Curve (AUC) under 180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||mg/dL * hours||Inter-Quartile Range|Median
7150|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values <50 mg/dL|Percentage of time CGM measured glucose values <50 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage of sensor hours||Inter-Quartile Range|Median
7151|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values <60 mg/dL|Percentage of time CGM measured glucose values <60 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of sensor hours||Inter-Quartile Range|Median
7152|NCT02137512|Secondary|Glucose Coefficient of Variation|Measure of CGM glucose variability in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||percentage||Inter-Quartile Range|Median
7153|NCT02137512|Secondary|Percentage of Time Sensor Glucose Values 70 to 180 mg/dL|Percentage of time sensor glucose values 70 to 180 mg/dL during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of sensor hours||Inter-Quartile Range|Median
7154|NCT02137512|Secondary|Mean Glucose|Mean glucose during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.||mg/dl||Standard Deviation|Mean
7155|NCT02137512|Secondary|Time Spent in Hypoglycemia- Overnight Closed-loop Only|Percent median time spent with sensor glucose ≤70 mg/dl during study system use at home in closed-loop configuration at night only when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of hours||Inter-Quartile Range|Median
7156|NCT02137512|Primary|Time Spent in Hypoglycemia- 24 Hour Closed Loop|Percent median time spent with sensor glucose ≤70 mg/dl during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data||percentage of hours||Inter-Quartile Range|Median
7157|NCT02137382|Secondary|Percentage of Days With Formed/Normal Stools|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/ number of days recorded in diary).|5 days|Per protocol||percentage of days||Standard Deviation|Mean
7158|NCT02137382|Secondary|Percentage of Days With no Abdominal Pain|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain/ number of days recorded in diary).|5 days|Per protocol||percentage of days||Standard Deviation|Mean
7159|NCT02137382|Secondary|Percentage of Days With no Flatulence|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary).|5 days|Per protocol||percentage of days||Standard Deviation|Mean
7160|NCT02137382|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period|5 days|Per protocol||number of stools per day||Standard Deviation|Mean
7161|NCT02137382|Secondary|Total Fat Excretion|Total amount of fat excreted during the stool collection period in grams.|5 days|Per protocol||Grams||Standard Deviation|Mean
7162|NCT02137382|Secondary|Coefficient of Nitrogen Absorption (CNA).|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|5 days|Per protocol||percentage of nitrogen intake||Standard Deviation|Mean
7163|NCT02137382|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|5 days|Per protocol||percentage of fat intake||Standard Deviation|Mean
7164|NCT02136498|Secondary|Number of Days of Varenicline Use|Number of days varenicline was used|5 mo follow-up|||Mean number of days||Standard Deviation|Mean
7165|NCT02136498|Primary|Point Prevalence Abstinence|Self-report of no-smoking, even a puff during the last 7 days.|5 month follow-up|Intent to treat analyses with missing cases imputed as smokers.||Percentage of people not smoking|||Number
7166|NCT02136238|Primary|Physical Function Performance 10 Test Score|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.|||units on a scale||Standard Deviation|Mean
7167|NCT02136238|Primary|Sternal Displacement During Towel Folding Task|Distance sternum is displaced while folding a towel was measured in meters.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.|||meters||Standard Deviation|Mean
7168|NCT02136134|Secondary|Overall Survival (OS)|Overall Survival was measured from the date of randomization to the date of the participant's death.|Up to the end of the study (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
7169|NCT02136134|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.||percentage of participants|||Number
7181|NCT02136004|Primary|Time to Hemostasis|Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis|procedural, usually within 15 minutes of enrollment|All subjects enrolled||minutes||95% Confidence Interval|Mean
7182|NCT02135900|Primary|Mean Oxygen Saturation (M SO2)|Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Percentage of oxygen saturation||95% Confidence Interval|Mean
7183|NCT02135900|Primary|Lowest Oxygen Saturation (L SO2)|Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Percentage of oxygen saturation||95% Confidence Interval|Mean
7170|NCT02136134|Secondary|Overall Response Rate (ORR)|The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Up to disease progression (approximately of 3 years)|The response-evaluable analysis set is defined as participants who have confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment and had at least 1 post baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
7171|NCT02136134|Secondary|Percentage of Participants With a Very Good Partial Response (VGPR) or Better|Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The response evaluable analysis set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment, and had at least 1 post baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
7172|NCT02136134|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
7173|NCT02136134|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
7174|NCT02136004|Secondary|Procedure Success|Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days|through 30 days +/- 7 days|All subjects enrolled.||Participants|||Count of Participants
7175|NCT02136004|Secondary|Rate of Combined Minor Access Site Closure-related Complications|Secondary safety endpoint - rate of combined minor access site closure-related complications|through 30 +/- 7 days|All subjects enrolled||Participants|||Count of Participants
7176|NCT02136004|Secondary|Device Success|Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression|procedural, usually within 15 minutes of enrollment|All subjects enrolled||Participants|||Count of Participants
7177|NCT02136004|Secondary|Time to Hospital Discharge|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward|through hospital discharge, usually within 24 hours|All subjects enrolled||hours||95% Confidence Interval|Mean
7178|NCT02136004|Secondary|Time to Discharge Eligibility|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)|prior to hospital discharge, usually within 24 hours|All subjects enrolled||hours||95% Confidence Interval|Mean
7179|NCT02136004|Secondary|Time to Ambulation|Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site|prior to hospital discharge, usually within 24 hours|All subjects enrolled||hours||95% Confidence Interval|Mean
7180|NCT02136004|Primary|Rate of Combined Major Access Site Closure-related Complications|Primary safety endpoint - rate of combined major access site closure-related complications|Through 30 days +/- 7 days|All subjects enrolled||Participants|||Count of Participants
7251|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge|Hospital discharge|||participants|||Number
7184|NCT02135900|Primary|Apnea Index (AI)|Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Number of apneas per hour sleep||95% Confidence Interval|Mean
7185|NCT02135900|Primary|Apnea Hypopnea Index|Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography||Apneas or hypopneas per hour sleep||95% Confidence Interval|Mean
7186|NCT02135016|Secondary|The Block Level of Epidural Anesthesia|The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).|20 mins after epidural anesthesia|||units on a scale||Standard Deviation|Mean
7187|NCT02135016|Secondary|The Heart Rate|The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||beats per minute||Standard Deviation|Mean
7188|NCT02135016|Secondary|The Mean Blood Pressure|The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||mmHg||Standard Deviation|Mean
7189|NCT02135016|Secondary|The Bispectral Index|The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||units on a scale||Standard Deviation|Mean
7190|NCT02135016|Primary|The Effect-site Concentration of Propofol|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour|||µg/ml||Standard Deviation|Mean
7191|NCT02134977|Secondary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event was occurred in breast cancer female.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.||participants|||Number
7192|NCT02134977|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.||participants|||Number
7193|NCT02134977|Secondary|Percentage of Participants With Positive Change in Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was the change in agents good? and the options of the answers were very good, somewhat good, whether or not the change in agents was good cannot be determined, somewhat bad, very bad."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
7194|NCT02134977|Secondary|Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in pain at the time of injection due to the change in agents? and the options of the answers were significantly relieved, slightly relieved, whether or not the pain worsened or was relieved cannot be determined, worsened slightly, and worsened significantly."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
7195|NCT02134977|Secondary|Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in adverse drug reactions (e.g., menopausal-like symptoms such as hot flushes, injection-site abnormalities) due to the change in agents? and the options of the answers were events became much less severe, events became less severe, whether or not the events became severe cannot be determined, events became slightly more severe, and events became very severe."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
7252|NCT02132767|Secondary|Time to Conversion to Sustained, Stable Non-AF Rhythm||Up to index hospital discharge or 7 days post surgery, whichever came first|All randomized patients (intent to treat)||days||Inter-Quartile Range|Median
7253|NCT02132767|Primary|Total Number of Days in Hospital|The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.|Within 60 days of randomization|All randomized patients (intent to treat)||days||Inter-Quartile Range|Median
7196|NCT02134977|Secondary|Percentage of Participants Who Worried About the Effect of the Medicinal Agent|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you worry about the effect? and the options of the answers were not at all worried, not too worried, no thought either way, somewhat worried, and very worried."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
7197|NCT02134977|Secondary|Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did you feel relief from financial burden (example, 3 months’ drug costs and transportation fee) due to the change in agents? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief. The sum of all the categories is not 100% because of rounding error."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
7198|NCT02134977|Secondary|Percentage of Participants Who Felt Relief From Physical and Emotional Burden|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you feel relief from physical and emotional burden? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
7199|NCT02134977|Secondary|Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did the change in agents reduce the frequency of your medical visits? and the answers were categorized as very much reduced, somewhat reduced, unchanged. Change in medicinal agents means participants with a historical diagnosis of premenopausal breast cancer who switched to leuprorelin acetate sustained-release 11.25 mg injection kit from a 4-week adjuvant therapy with a LH-RHa 1 month depot preparation as part of daily medical practice."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||percentage of participants|||Number
7200|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 48|Efficacy assessment population where Week 48 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7201|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 12|Efficacy assessment population where Week 12 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7202|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Baseline|Efficacy assessment population where baseline assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7203|NCT02134977|Primary|Score of QOL-ACD-B at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7254|NCT02132611|Secondary|Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours|||percentage of procedures||95% Confidence Interval|Number
8713|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (> 5 Years)|Artefenomel concentration on Day 7 in African Patients > 5 years. All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
7204|NCT02134977|Primary|Score of QOL-ACD-B at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7205|NCT02134977|Primary|QOL-ACD Breast (QOL-ACD-B) Score at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score was calculated over score range 0-100 for item 1 to 18 as ((a sum of 18 items)/18-1)*25). Score for physical condition and pain was calculated over score range 0-100 for item 1 to 6 as ((a sum of 6 items)/6-1)*25)). Score for health-care and illness satisfaction was calculated over score range 0-100 for item 7 to 10 as ((a sum of 4 items)/4-1)*25)), where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7206|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 48|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7207|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 12|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale:5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7208|NCT02134977|Primary|Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.||units on a scale||Standard Deviation|Mean
7209|NCT02134587|Secondary|Quality of ADE Reports|Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form.|Two days|The subjects were assessed regarding pharmacovigilance´s skills prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in contribute on the improvement of the quality of information inserted on the form.||percent of correctly filled forms||Full Range|Median
7311|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort|Surveyed after 1 hour post settling (1 hour) for Pair #1. Rated by questionnaires (0-100, 0- Can't be worn and causes pain, 100= can't feel).|1 hour post settling|||units on a scale||Standard Deviation|Mean
7210|NCT02134587|Secondary|Knowledge (Awareness) Regarding Pharmacovigilance|Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals.|Two days|The subjects were assessed regarding pharmacovigilance´s knowledge prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in aware health professionals to report adverse drug events.||percentage of right answers||Full Range|Median
7211|NCT02134587|Primary|Absolute Number of ADE Reporting (Change Behavior of Health Professionals)|Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.|12 months|Before educational intervention, health professionals reported only three adverse drug events, related to therapeutic failure. However, after the study, the number of reports rise 70-fold, since subjects reported 165 medication errors, 26 adverse drug reactions, 18 quality deviations, 5 therapeutic failure and one off-label use.||absolute number of adverse drug events|||Number
7212|NCT02134184|Other Pre-specified|To Compare the T- and B-cell Response to Licensed IM TIV in Elderly Individuals Dependent on the Presence and Duration of CMV Infection by Analyses of Vaccine-induced Plasmablasts, Antibodies and Antigen-specific T Cells||Day 0 to Day 28||||||
7213|NCT02134184|Secondary|Number of Participants With Related Adverse Events||Day 0 to Day 28|||Participants|||Count of Participants
7214|NCT02134184|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to Day 28|||Participants|||Count of Participants
7215|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||g/dL||Standard Deviation|Mean
7216|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||g/dL||Standard Deviation|Mean
7217|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||g/dL||Standard Deviation|Mean
7218|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||percent of red blood cells in blood||Standard Deviation|Mean
7219|NCT02134119|Secondary|Hematological Measures -Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||percent of red blood cells in blood||Standard Deviation|Mean
7220|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||percent of red blood cells in blood||Standard Deviation|Mean
7221|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||ng/mL||Standard Deviation|Mean
7222|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||ng/mL||Standard Deviation|Mean
7223|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||ng/mL||Standard Deviation|Mean
7224|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||mU/mL||Standard Deviation|Mean
7225|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||mU/mL||Standard Deviation|Mean
7226|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||mU/mL||Standard Deviation|Mean
7227|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days|||M/uL||Standard Deviation|Mean
7228|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)|||M/uL||Standard Deviation|Mean
7229|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)|||M/uL||Standard Deviation|Mean
7230|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|35-days|||ml/kg/min||Standard Deviation|Mean
7287|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)|Baseline (insertion)|||LogMAR||Standard Deviation|Mean
7231|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|0-days (baseline)|||ml/kg/min||Standard Deviation|Mean
7232|NCT02133534|Primary|Improved Counts of Endothelial Progenitor Cells|Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.|baseline, 30 days|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
7233|NCT02133235|Primary|Time Required for Proper Placement of the Endobronchial Blocker||10-15 minutes|||seconds||Standard Deviation|Mean
7234|NCT02133235|Primary|Surgical Grading for Lung Isolation|A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement|10-15 minutes|||participants|||Number
7235|NCT02133131|Secondary|Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)|The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 16 weeks|Analysis of SVR4 is ongoing and results will be indicated in a future report.|||||
7236|NCT02133131|Primary|Number of Participants Discontinuing Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population consists of all participants who received ≥1 dose of study drug.||Number of participants|||Number
7237|NCT02133131|Primary|Number of Participants Experiencing at Least 1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All Participants as Treated (APaT) population consists of all participants who received ≥1 dose of study drug.||Number of participants|||Number
7238|NCT02133131|Primary|Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)|The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 24 weeks|The Per Protocol (PP) population includes all randomized and treated participants who did not have protocol deviations that may substantially affect the results of the primary and secondary endpoints.||Percentage of participants||95% Confidence Interval|Number
7239|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4; Baseline to Week 8|||units on a scale||95% Confidence Interval|Mean
7240|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4|||units on a scale||95% Confidence Interval|Mean
7241|NCT02132936|Secondary|Time to ‘Treatment Success’ According to PGA.|"Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.~‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline."|From Baseline to Week 12|||weeks||Inter-Quartile Range|Median
7242|NCT02132936|Secondary|Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.|Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.|Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel|||percentage of subjects|||Number
7243|NCT02132936|Primary|Treatment Success According to the PGA|"To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.~Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician’s Global Assessment of Disease Severity (PGA).~‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline."|4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel|||percentage of subjects|||Number
7244|NCT02132767|Secondary|Cost (Hospital)|Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups|Within 60 days of randomization||||||
7245|NCT02132767|Secondary|AF- or Treatment-related Events||Within 60 days of randomization||||||
7246|NCT02132767|Secondary|Outpatient Interventions|Compare frequency of outpatient visits between groups for any cause and AF-related causes|Within 60 days of randomization|||hospital stays < 24 hours|||Number
7247|NCT02132767|Secondary|Length of Stay (Rehospitalization, Including ED Visits)|Compare frequency of readmissions between groups for any cause and AF-related hospitalizations|Within 60 days of randomization|||days||Inter-Quartile Range|Median
7248|NCT02132767|Secondary|Length of Stay (Index Hospitalization)|Overall length of stay for the index hospitalization|Within 60 days post surgery|||days||Inter-Quartile Range|Median
7249|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization|60 days after randomization|||participants|||Number
7250|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization|30 days after randomization|||participants|||Number
7255|NCT02132611|Primary|Major Adverse Cardiac Event (MACE)|"A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.~30-Day MACE is composed of:~Cardiac death~Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave~Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure"|30 Days|||Percent Probability of Freedom from MACE||95% Confidence Interval|Number
7256|NCT02132572|Primary|Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant|Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.|3 to 10 years|Per Protocol: Subjects who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants 3 to 10 years prior to data collection||Percentage of Subjects|||Number
7257|NCT02132117|Secondary|Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement.|Baseline, Day 1 (Hour 1)|ITT Population included all randomized participants.||percentage of participants|||Number
7258|NCT02132117|Secondary|Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29|Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: “Right now, how much does your face burn because of your facial redness?” using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants, with data available for analysis at the given time-point. Only participants who had a SA-RFR score of 1-4 at Baseline are included in the Analysis.||score on a scale||Standard Deviation|Mean
7259|NCT02132117|Secondary|Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29|Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: “Right now, how satisfied are you with the effect your study medication had on your facial redness?” using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported.|Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants with data available for analysis.||percentage of participants|||Number
7260|NCT02132117|Secondary|Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29|DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.||percent change in area of redness||Full Range|Median
7261|NCT02132117|Secondary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.||percentage of participants|||Number
7262|NCT02132117|Primary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales|The investigator assessed the participant’s overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Intent-to-treat (ITT) Population included all randomized participants.||percentage of participants|||Number
7263|NCT02131636|Secondary|Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 1 (Hour 1)|Intent-to-Treat: all randomized patients||Percentage of Pateints|||Number
7264|NCT02131636|Secondary|Change From Baseline on the SA-RFR Questionnaire Item #4|The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
7265|NCT02131636|Secondary|Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9|The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as “very satisfied” or “satisfied” are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.|Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
7266|NCT02131636|Secondary|Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)|Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients with data at the time point||Percent Change||Standard Deviation|Mean
7267|NCT02131636|Secondary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
7268|NCT02131636|Primary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales|The investigator assessed the patient’s overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
7269|NCT02131532|Primary|Feasibility of Follow-up Assessment at Three Months After the End of Treatment|Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.|3 months after the end of treatment|||participants|||Number
7270|NCT02131532|Primary|Feasibility of Telephone-delivered Booster Sessions|Numbers of participants who attended the booster session as planned and those who rearranged the session|3 months after the end of treatment|||participants|||Number
7271|NCT02131532|Primary|Attendance of Treatment Sessions|Number of participants who completed all treatment sessions.|3 months after the end of treatment|||participants|||Number
7272|NCT02131532|Primary|Feasibility of Recruitment Process|The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.|3 months after the end of treatment|||participants|||Number
7273|NCT02131532|Secondary|SIS - Social Activity|The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7274|NCT02131532|Secondary|SIS - Hand Function|The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7275|NCT02131532|Secondary|SIS - Mobility|The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7276|NCT02131532|Secondary|SIS - Daily Activities|The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7277|NCT02131532|Secondary|SIS - Communication|The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7278|NCT02131532|Secondary|SIS - Emotion|The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7279|NCT02131532|Secondary|SIS - Memory and Thinking|The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7280|NCT02131532|Secondary|SIS - Physical Strength|The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7281|NCT02131532|Secondary|Stroke Impact Scale (SIS) - General Rating of Recovery|The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7282|NCT02131532|Secondary|Nottingham Extended Activities of Daily Living (NEADL)|The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7283|NCT02131532|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7284|NCT02131532|Secondary|Fatigue Assessment Scale (FAS)|"This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study).~The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity."|3 months after the end of treatment|||units on a scale||Standard Deviation|Mean
7285|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)|2 hour at insertion|||LogMAR||Standard Deviation|Mean
7286|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)|1 hour at insertion|||LogMAR||Standard Deviation|Mean
7288|NCT02131402|Primary|Participants Subjective Rating for Stinging/Burning|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)|1 hour post settling|||units on a scale||Standard Deviation|Mean
7289|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning|Surveyed after 1 hour post settling (3 hours) for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).|3 hours post settling|||units on a scale||Standard Deviation|Mean
7290|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning|Surveyed after 1 hour post settling (2 hours) for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).|2 hours post settling|||units on a scale||Standard Deviation|Mean
7291|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning|Surveyed after insertion of each lens Pair #2 (1 hour at insertion). Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)|1 hour at insertion|||units on a scale||Standard Deviation|Mean
7292|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning|Surveyed after insertion of each lens for Pair #3 (2 hours) . Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)|2 hours at insertion|||units on a scale||Standard Deviation|Mean
7293|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning|Surveyed after insertion of each lens for Pair #1 at (Baseline visit). Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).|Baseline|||units on a scale||Standard Deviation|Mean
7294|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration|Assessed after 1 hour post settling (3 hours) for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|3 hours post settling|||percentage of eyes|Participants||Number
7295|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration|Assessed after 1 hour post settling (2 hours) for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|2 hours post settling|||percentage of eyes|Participants||Number
7296|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration|Assessed after 1 hour post settling (1 hour) of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|1 hour post settling|||percentage of eyes|Participants||Number
7297|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test|Assessed after 1 hour post settling (3 hours) for Pair #3. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)|3 hours post settling|||units on a scale||Standard Deviation|Mean
7298|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test|Assessed after 1 hour post settling (2 hours) for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)|2 hours post settling|||units on a scale||Standard Deviation|Mean
7299|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test|Assessed after 1 hour post settling (1 hour) of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)|1 hour post settling|||units on a scale||Standard Deviation|Mean
7300|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag|Assessed after 1 hour post settling (3 hours) for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|3 hours post settling|||units on a scale||Standard Deviation|Mean
7301|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag|Assessed after 1 hour post settling (1 hour) of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling|||units on a scale||Standard Deviation|Mean
7302|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag|Assessed after 1 hour post settling (2 hours) for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|2 hours post settling|||units on a scale||Standard Deviation|Mean
7303|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference|Surveyed after 1 hour post settling (3 hours) for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|3 hours post settling|||percentage of eyes|Participants||Number
7304|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference|Surveyed after 1 hour post settling (2 hours) for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|2 hours post settling|||percentage of eyes|Participants||Number
7305|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference|Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|1 hour post settling|||percentage of eyes|Participants||Number
7306|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference|Surveyed after insertion of each lens Pair #2 (1 hour at insertion) by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|1 hour at insertion|||percentage of eyes|Participants||Number
7307|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference|Surveyed after insertion of each lens for Pair #3 (2 hours). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|2 hours at insertion|||percentage of eyes|Participants||Number
7308|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference|Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|Baseline|||percentage of eyes|Participants||Number
7309|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort|Surveyed after 1 hour post settling (3 hours) for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).|3 hours post settling|||units on a scale||Standard Deviation|Mean
7313|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Insertion|Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).|Baseline|||units on a scale||Standard Deviation|Mean
7314|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort-Insertion|Surveyed after insertion of each lens Pair #2 (1 hour at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).|1 hour at insertion|||units on a scale||Standard Deviation|Mean
7315|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3 at (3 hours). Rated by questionnaires (0-100 0=Very difficult, 100= very easy).|3 hours post settling|||units on a scale||Standard Deviation|Mean
7316|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling|Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (2 hours). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).|2 hours post settling|||units on a scale||Standard Deviation|Mean
7317|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).|1 hour post settling|||units on a scale||Standard Deviation|Mean
7318|NCT02131311|Secondary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||percentage of subjects|||Number
7319|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of a 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||grams/usage period||Inter-Quartile Range|Median
7320|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||number of episodes/usage period||Inter-Quartile Range|Median
7321|NCT02131311|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = ‘Not at all,’ 1= ‘Slightly,’ 2 = ‘Moderately,’ or 3 ‘Greatly.’ The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at end of treatment"||units on a scale||Inter-Quartile Range|Median
7322|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||grams/usage period||Inter-Quartile Range|Median
7323|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||episodes/usage period||Inter-Quartile Range|Median
7324|NCT02131311|Primary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||percentage of subjects|||Number
7325|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 96||12/2017||||
7326|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE at Week 96|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician will evaluate whether or not a SAE is drug-related.|Up to Week 96||12/2017||||
7327|NCT02131233|Secondary|Percentage of Participants With a SAE at Week 96|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 96||12/2017||||
7339|NCT02130999|Other Pre-specified|Number of Participants That Reported Suicidal Ideation, Suicidal Behavior, or Suicide Attempts.|Number of Participants that reported suicidal ideation, suicidal behavior, or suicide attempts per treatment arm and overall.|Baseline to End of Study Day 5 (± 2 days).|||participants|||Number
7340|NCT02130999|Secondary|Number of Participants With Adverse Events|Number of participants with treatment-emergent adverse event per treatment arm and overall.|From Baseline to End of Study; Day 5 (± 2 days).|||participants|||Number
7328|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE at Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 96||12/2017||||
7329|NCT02131233|Secondary|Percentage of Participants With an AE at Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 96||12/2017||||
7330|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
7331|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE at Week 48|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
7332|NCT02131233|Secondary|Percentage of Participants With a Serious Adverse Event (SAE) at Week 48|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
7333|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
7334|NCT02131233|Secondary|Percentage of Participants With an Adverse Event (AE) at Week 48|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 48|All randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
7335|NCT02131233|Secondary|Change From Baseline in CD4 Cell Count at Week 96|CD4 cells will be counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values.|Baseline and Week 96||12/2017||||
7336|NCT02131233|Secondary|Percentage of Participants Achieving <40 Copies/mL HIV-1 RNA at Week 96|From blood samples collected at week 96, HIV-1 RNA levels will be determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL.|Week 96||12/2017||||
7337|NCT02131233|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values.|Baseline and Week 48|All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.||cells/mm^3||95% Confidence Interval|Mean
7338|NCT02131233|Primary|Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48|From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA “snapshot” approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.|Week 48|All randomized participants who received at least one dose of study treatment||Percentage of participants||95% Confidence Interval|Number
7341|NCT02130999|Secondary|Metabolite-to-parent AUC(Inf) Ratios After Oral Administration of a Single 20 mg Dose and IV Administration of a Single 2 mg Dose of Tasimelteon|Comparison of the metabolite-to-parent AUC(inf) ratios for the oral and IV routes.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||metabolite to parent AUC (inf) ratios||Standard Deviation|Mean
7342|NCT02130999|Secondary|AUC(Inf) of Tasimelteon’s Metabolites After a Single Oral and I.V. Dose|The mean +/- SD for the AUC(inf) of tasimelteon’s metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|Only 11 subjects could be analyzed for M11.||h*ng/mL||Standard Deviation|Mean
7343|NCT02130999|Secondary|Cmax of Tasimelteon's Metabolites After an Oral and I.V. Dose of Tasimelteon|The mean +/- SD for the Cmax of tasimelteon’s metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||ng/mL||Standard Deviation|Mean
7344|NCT02130999|Secondary|Total Clearance of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|CL of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||(mL/min)||Standard Deviation|Mean
7345|NCT02130999|Secondary|T1/2 of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|T1/2 of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours pos-dose|||hour||Standard Deviation|Mean
7346|NCT02130999|Secondary|AUC (Inf) of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|AUC (inf) of Tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||(h*ng/mL)||Standard Deviation|Mean
7347|NCT02130999|Secondary|Cmax of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|Cmax of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||ng/mL||Standard Deviation|Mean
7348|NCT02130999|Primary|Absolute Bioavailability After a Single Oral Dose of Hetlioz™(Tasimelteon) 20mg|The absolute bioavailability (F) of tasimelteon will be estimated from the dose-corrected AUC(inf) after oral and I.V. administration using an analysis of variance (ANOVA) model with treatment, period, sequence, and subject within sequence as the classification variables, using natural log-transformed data. The geometric mean ratio (GMR), oral-to-I.V., and its associated 90% confidence interval (CI) will be used as the estimate of F and its variability.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|||Geometric Mean Ratio (%)||90% Confidence Interval|Geometric Mean
7349|NCT02129608|Primary|Change in Weight|The change in weight from baseline to 3 months|3 months|||kg||Standard Deviation|Mean
7350|NCT02129608|Primary|Change in Waist Circumference|The change in waist circumference from baseline to 3 months|3 months|||cm||Standard Deviation|Mean
7351|NCT02129062|Primary|Overall Survival Time|The time measurement from beginning treatment to recurrent or progressive disease is objectively documented. Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups such as age groups, or Philadelphia chromosome-positive versus Philadelphia chromosome-negative B-ALL. Progressive disease is defined as a doubling of the peripheral blasts and an absolute increase of > 5 x 10^9/L.|Up to thirty days after after completion of study treatment anticipated to be 12 weeks for total of 16 weeks|Study terminated early due to slow enrollment, insufficient data . One participant was not evaluable due to early death, other two participants were removed from the study within 30 days of study start due to disease progression prior to scheduled treatment evaluations.|||||
7352|NCT02129062|Primary|Objective Response Rate (ORR)|ORR is defined as the proportion of participants with complete or partial response. Response definitions of Complete Response (CR): disappearance of leukemia as indicated by <5% marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) >1000/μL & platelets >100,000/μL. C1 extramedullary disease status required. CR with incomplete count recovery (CRi): CR except with ANC <1000/μL and/or platelets <100,000/μL. Partial response (PR): improved or no worsening of ALL as indicated by no peripheral blood blasts, neutrophils >1000/μL, platelets >100,000μL, and either or both of the following: >50% decrease in marrow blast percentage, compared to pretreatment value, & marrow blast percentage ≥ 5% and ≤ 25%. C2 extramedullary disease status. Treatment failures are defined as participants who fail to achieve CR, CRi or PR.|3 months after treatment|One of three participants was not evaluable for response.||percentage of participants|||Number
7353|NCT02128867|Other Pre-specified|Sa02|SaO2 will be measured during 15 minutes of treatment time|15 minutes||||||
7354|NCT02128867|Other Pre-specified|Heartrate|heartrate will be measured during 15 min of treatment time|15 minutes||||||
7355|NCT02128867|Secondary|Duration of Reflux Episodes|duration of reflux episodes will be measured during 15 min of treatment time|15 minutes||||||
7356|NCT02128867|Primary|Number of Refluxes|number of refluxes will be counted over a period of 15 minutes ( treatment time )|15 minutes|||number of refluxes||Standard Deviation|Mean
7357|NCT02128542|Secondary|Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment|Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L.|Pretreatment and Posttreatment Week 12|Participants who relapsed and qualified for sequencing analysis were analyzed.||participants|||Number
7358|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.|Up to Posttreatment Week 12|Participants in the Full Analysis Set with available data were analyzed||Percentage of participants|||Number
7359|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Breakthrough|"Viral breakthrough was defined as either:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment~HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values"|Up to Posttreatment Weak 12|Full Analysis Set||Percentage of participants|||Number
7360|NCT02128542|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.|Posttreatment Week 4|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
7361|NCT02128542|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug||Percentage of participants|||Number
7362|NCT02128542|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
7363|NCT02128490|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
7364|NCT02128490|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.||percentage of participants|||Number
7365|NCT02128490|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.||percentage of participants|||Number
7366|NCT02127567|Secondary|Average Score for Completeness of Reporting of Essential Elements|Completeness of reporting scores calculated based on essential elements to report, on a scale from 0 to 10, 0 being the lowest and10 the highest|one time four hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7367|NCT02127567|Secondary|The Score for Completeness of Reporting for Trial Design|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7368|NCT02127567|Secondary|The Score for Completeness of Reporting for Outcomes|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7369|NCT02127567|Secondary|The Score for Completeness of Reporting for Interventions|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7370|NCT02127567|Secondary|The Score for Completeness of Reporting for Participants|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7371|NCT02127567|Secondary|The Score for Completeness of Reporting for Blinding|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7372|NCT02127567|Secondary|The Score for Completeness of Reporting for Randomization|The score for completeness of reporting (0-10) for the manuscript section randomization, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7373|NCT02127567|Primary|The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.|Completeness of reporting will be determined according to a grading rubric individualized to each study protocol, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session|||units on a scale|Participants|Standard Deviation|Mean
7374|NCT02127372|Primary|Phase II - Radiographic Response|"The percentage of patients with a complete or partial response.~Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|After Cycle 6, approximately 18 weeks.|||percentage of participants||95% Confidence Interval|Number
7375|NCT02127372|Secondary|Change in Gd-MRI Measurement|The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.|Day 7|Because the study was terminated prior to completion, correlative studies were not run.|||||
7376|NCT02127372|Secondary|Phase 2: 1 Year Survival|Phase II: Percentage of patients alive 1 year from the start of protocol treatment.|1 year|||percentage of participants||95% Confidence Interval|Number
7377|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.||mg/m2|||Number
7378|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of STI571|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.||mg|||Number
7453|NCT02121860|Primary|AUC|Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);|48 Hours|The analyzed sample size was 36 subjects: 12 subjects with mild, and 8 subjects each with moderate and severe hepatic impairment, and with normal hepatic function.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
7379|NCT02126839|Secondary|Summary of Participants With Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).~Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|6 Months|Safety Analysis set includes all participants who receive at least 1 dose of study drug. In this population, treatment is assigned based upon the treatment participants actually receive, regardless of the treatment to which they were randomized.||participants|||Number
7380|NCT02126839|Secondary|Baseline Adjusted Peak Expiratory Flow (PEF) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Serial PEF measurements were obtained via spirometry. PEF measures for purpose of serial PEF assessment (pre and postdose) were collected from the spirometer assessed PEF, utilizing the values from the efforts selected based on the highest of 3 acceptable FEV1 maneuvers.|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|Full analysis set||Liters/min*hour||Standard Error|Least Squares Mean
7381|NCT02126839|Primary|Baseline Adjusted Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Following measurement of the baseline FEV1 and dose administration on Days 1 and 22, FEV1 values (highest of 3 acceptable maneuvers) will be obtained at 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±10), 120 (±10), 240 (±10), and 360 (±10) minutes after the completion of dosing. Predicted FEV1 values were computed and adjusted for age, height, and gender according to Eigen et al (Eigen et al 2001) for participants 4 to 5 years of age and to Quanjer et al (Quanjer et al 1995) for participants aged 6 to 11 years using ATS criteria (American Thoracic Society/European Respiratory Society Statement 2007).|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|The full analysis set (FAS) includes all participants in the ITT population who receive at least 1 dose of study medication and have at least 1 postbaseline assessment of the primary endpoint.||% predicted FEV1/hour||Standard Error|Least Squares Mean
7382|NCT02126748|Secondary|Oxygen Saturation (SaO2)|oxygen saturation (SaO2) measured by pulse -oximetry|before, after and 1h after treatment||||||
7383|NCT02126748|Secondary|Heartrate||before, after and 1h after intervention||||||
7384|NCT02126748|Secondary|Wang Score||before treatment, immediately after treatment and 1h after treatment||||||
7385|NCT02126748|Primary|Length of Hospital Stay|Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)|6 days|||days||Standard Deviation|Mean
7386|NCT02126670|Secondary|Irritation Score|Percentage of participants with moderate or severe overall irritation at end of treatment.|up to Day 57|Overall irritation||percentage of participants|||Number
7387|NCT02126670|Primary|Treatment Success at End of Study Visit|Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions|up to Day 57|Per protocol||percentage of participants||95% Confidence Interval|Number
7388|NCT02126306|Primary|Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol|"Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made.~Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included."|Total score from baseline compared with week 40.|||participants|||Number
7389|NCT02125877|Secondary|Dererasirox Plasma Concentration|Blood samples were collected to assess deferasirox concentration. Dose-adjusted calculations are presented: (concentration/actual dose)*20 for participants on DFX-DT and (concentration/actual dose)*14 for participants on DFX-FCT.|Week 3, day 1, pre-dose (0 hour (h)) and 2 h post-dose; week 13, day 1, pre-dose (0 hour (h)) and 2 h post-dose; and week 21, day 1, pre-dose (0 hour (h)) and 2 h post-dose|The Pharmacokinetic analysis set for all participants was considered for this analysis, but only participants with non-missing values were included in the analysis.||umol/L||Standard Deviation|Mean
7390|NCT02125877|Secondary|Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)|Blood samples were collected to assess Tmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed||hour||Full Range|Median
7391|NCT02125877|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax)|Blood samples were collected to assess Cmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed||umol/L||Standard Deviation|Mean
7392|NCT02125877|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|Blood samples were collected to assess AUClast.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed.||umol/L*h||Standard Deviation|Mean
8714|NCT02083380|Other Pre-specified|Artefenomel Cday7 Asian Patients (All Ages)|Artefenomel concentration on Day 7 in Asian Patients (all ages). All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
7393|NCT02125877|Secondary|Weekly Dose Violation Rate|The dose violation is defined as a dose either missed completely or not taken in accordance with the timing instruction (no later than 12:00 pm. The rate was calculated as [number of dose violations/drug exposure (days)] x 100.|weeks 1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||percent dose violation||Standard Deviation|Mean
7394|NCT02125877|Secondary|Number of Participants With Weekly Average Compliance of Medication Consumption|A compliance questionnaire assessed whether the medication was taken. Weekly average compliance was calculated when there were at least four non-missing daily responses.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Participants|||Number
7395|NCT02125877|Secondary|Weekly Average of Daily Scores of the Gastrointestinal (GI) Symptom Diary|The GI symptom diary consisted of 6 items, five which were scored using a 0 - 10 rating scale with item appropriate anchors to rate the symptom, for example, Pain in your belly: 0 = no pain and 10 = worst pain. The GI diary summary score was created using the 10 point response scale for the 5 items. The GI symptom daily diary had a minimum score of 0 and a maximum score of 50. The weekly average score for the 7 days was calculated for each individual item and the GI summary score was created from these weekly averages. Higher scores indicated worse symptoms. A meaningful difference between two treatment arms was determined to be 0.3 point.|weeks -1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||score on a scale||Standard Deviation|Mean
7396|NCT02125877|Secondary|Palatability Questionnaire Score|"The palatability questionnaire consisted of 4 items. The first item measured the taste and aftertaste of the medication and were scored a on a 5-point response scale. The second item offered an additional response option of no aftertaste. The last 2 items referred to whether the medication was taken, i.e. swallowed or vomited, and how the participant perceived the amount of medication to be taken. The palatability summary score was calculated using a scoring matrix from items 1, 3 and 4 scores and the score ranges from 0 - 11. Higher scores indicated the best palatability. A meaningful difference between two treatment arms was determined to be 1 point."|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||score on a scale||Standard Deviation|Mean
7397|NCT02125877|Secondary|Mean Domain Scores of the Modified Satisfaction With Iron Chelation Therapy (Modified SICT)|The modified SICT consisted of 13 items that represent 3 domains: adherence, satisfaction and concerns. The adherence domain consisted of 7 items, 6 which were measured using a 5-point response scale and was calculated by summing the 6 items. The score range from 6 to 30 and higher scores indicated worse adherence. The satisfaction domain consisted of 3 items, 2 which were measured using a 5-point response scale and was calculated by summing the 2 items. The score range from 2 to 10 and higher scores indicated worse satisfaction. The concerns domain consisted of 3 items to address any concerns or worries with his/her medication. All 3 items were measured on a 5-point response scale and were calculated by summing the 3 items. The score range from 3 to 15 and higher scores indicated fewer concerns. For all three domains, the meaningful difference between two treatment arms was determined to be 1 point.|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.||score on a scale||Standard Deviation|Mean
7398|NCT02125877|Secondary|Frequency of Selected Gastro-intestinal (GI) Adverse Events|The percentage of participants with any GI adverse event, diarrhea, constipation, nausea, vomiting, abdominal pain was assessed.|28 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
7399|NCT02125877|Primary|Overall Safety as Measured by Changes in Laboratory Values From Baseline|The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.|baseline (BL), 30 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
7400|NCT02125877|Primary|Overall Safety as Measured by Frequency of Adverse Events|The percentage of participants with adverse events, serious adverse events and deaths was assessed.|30 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.||Percentage of participants|||Number
7401|NCT02125734|Secondary|Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.|The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. One patient with missing data for this analysis.||Participants|||Number
7402|NCT02125734|Secondary|Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.|Patient preference after experiencing both treatments. The patient’s preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Three patients were missing data for the patient preference analysis.||Participants|||Number
7403|NCT02125734|Primary|Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation|Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.|week 4|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period||Liters||95% Confidence Interval|Least Squares Mean
23685|NCT01706588|Secondary|Trismus||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery||||||
7404|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results|Subjects underwent a standard 12-lead ECG 6 hours post-dose. The investigator assessed if the ECG tracing was normal or abnormal; if abnormal, the investigator made a determination of whether or not the abnormality was clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
7405|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Vital Signs|Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements, all measured 6 hours post-dose. Study personnel used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
7406|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Laboratory Results|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters, all measured 6 hours post-dose. All clinical laboratory assays were performed according to the laboratory’s normal procedures. Reference ranges were supplied by the laboratory and were used to assess the clinical laboratory data for clinical significance and out-of-range pathological changes. The investigator assessed out-of-range clinical laboratory values for clinical significance and indicated whether or not the values were clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
7407|NCT02125292|Secondary|Number of Participants Who Experienced an Adverse Event|Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.|4 days|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||participants|||Number
7408|NCT02125292|Primary|Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis|"The participants were asked to answer Yes or No to the following question: Would you be willing to take medicine this way on a regular basis if necessary? The number of participants who answered Yes is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
7409|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement The aftertaste (if present) was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
7410|NCT02125292|Primary|Number of Participants Who Detected an Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered Yes or No to the following question: Was there an aftertaste? The number of participants who answered Yes is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
7411|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine|"A taste assessment was completed immediately after investigational product was administered to assess the subject’s taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement The taste was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.||participants|||Number
7412|NCT02124863|Primary|Number of Refluxes|Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV|during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.|All patients receiving IPV were their own controls||number of refluxes||Standard Deviation|Mean
7413|NCT02124603|Secondary|Eradication Rate|Number of participants having positive culture at the screening visit with bacterial eradication before surgery|Day of surgery|Number of participants with positive culture at the screening visit||partecipants|||Number
7414|NCT02124603|Secondary|Antibiotic Susceptibility|Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.|At least 14 days before surgery|Percentage of isolates susceptibility to antibiotics||percentage of susceptible isolates|Participants||Number
7415|NCT02124603|Primary|Positive Culture in Subjects Scheduled for Cataract Surgery|Number of participants with positive culture at the screening visit|At least 14 days before surgery|Number of participants with positive culture||subjects|||Number
7416|NCT02123472|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Microgram per milliliter(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
7417|NCT02123472|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hours||Standard Deviation|Median
8715|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>=0.5 to <= 2 Years)|Piperaquine concentration at Day7 in African patients >= 0.5 and <= 2 years|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
7418|NCT02123472|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||hour*microgram per milliliter (h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
7419|NCT02123459|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hours||Standard Deviation|Median
7420|NCT02123459|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
7421|NCT02123459|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hours*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
7422|NCT02123446|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable PK data.||hours||Standard Deviation|Median
7423|NCT02123446|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
7424|NCT02123446|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Hour*microgram per milliliter(h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
7425|NCT02124304|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. Participants were asked to rate the intensity of an exercise on a scale from 0 to 10, 0 being no resistance and 10 being the maximum resistance.|12 exercises during one 1 hour session|||units on a scale, ranging from 0 to 10||Full Range|Mean
7426|NCT02124304|Primary|Percent of Peak Activation (%PA)|8 muscles during 12 exercises were analyzed in 30 subjects, totaling 2880 data points. At the beginning of the study, peak activation (PA) was assessed for each muscle during full flexion-extension, used as a reference exercise. For each subject, the EMG signals of the muscles during the 12 exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the PA for each muscle was determined, it was compared to the PA of the reference exercise for the respective muscle group, and expressed as a percent of the peak activation (%PA). In some cases the %PA is greater than 100%. This is possible as the PA was assessed during a full flexion-extension movement. During an exercise some muscles generated greater PA and therefore when the calculations were performed the %PA was greater than 100%. Due to the extensive amount of data, we have provided the Left Cervical Paraspinals %PA results for each exercise.|One 1 hour session|||Percentage of Peak Activation (%PA)||Full Range|Mean
7427|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1|"Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, number of participants analyzed signifies participants with valid and determinate assay results for specified strain at both the specified blood draws."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||fold rise||95% Confidence Interval|Geometric Mean
7428|NCT02124161|Secondary|Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers|"Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than <1:10 and after Vaccination 1 (post-vaccination 1) HAI titer >=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer >=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||percentage of participants||95% Confidence Interval|Number
7435|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 1|Safety population included all participants who received at least 1 dose of vaccination.||percentage of participants|||Number
7429|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, number of participants analyzed signifies total participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed."|Immediately before Vaccination 2, 1 month after Vaccination 2|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||fold rise||95% Confidence Interval|Geometric Mean
7430|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||fold rise||95% Confidence Interval|Geometric Mean
7431|NCT02124161|Secondary|Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)|"Percentage of participants achieving predefined OPA antibody titer >= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results to the specified serotype."|1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||percentage of participants||95% Confidence Interval|Number
7432|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 168 to 196 days after Vaccination 2|Safety population included all participants who received at least 1 dose of vaccination.||percentage of participants|||Number
7433|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."||percentage of participants|||Number
7434|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."||percentage of participants|||Number
7449|NCT02122406|Primary|Hospital Anxiety and Depression Scale (HADS)|Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.|1 day of enrollement|||participants|||Number
7450|NCT02121860|Primary|Cmax|Maximum concentration (Cmax)|48 Hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
7436|NCT02124161|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)|"HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies participants with a determinate HAI titer to the given strain."|1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||titer||95% Confidence Interval|Geometric Mean
7437|NCT02124161|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes|"Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with a determinate OPA titer to the given serotype."|1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.||titer||95% Confidence Interval|Geometric Mean
7438|NCT02123745|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.|After each participant has been infiltrated, an expected average of 1 hour|||participants|||Number
7439|NCT02123745|Secondary|Infiltrated Volume When Yellow Notification Issued|The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour|||mL|Participants|Standard Deviation|Mean
7440|NCT02123745|Secondary|Infiltrated Volume When Red Notification Issued|The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour|||mL|Participants|Standard Deviation|Mean
7441|NCT02123745|Secondary|Yellow Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour|||percentage of infiltrations|Participants|95% Confidence Interval|Number
7442|NCT02123745|Primary|Red Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour|||percentage of infiltrations|Participants|95% Confidence Interval|Number
7443|NCT02123017|Secondary|Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant|Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable|1 day post last consumption|||units on a VAS scale||Standard Deviation|Mean
7444|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity|Safety determined by the severity of treatment emergent adverse events.|1 day post last consumption|||Percentage of subjects|||Number
7445|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence|Safety determined by the incidence of treatment emergent adverse events.|1 day post last consumption|||% of patients with adverse events|||Number
7446|NCT02123017|Primary|Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.|Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.|10-14 hours post last consumption|||units on a scale||Standard Deviation|Mean
7447|NCT02122445|Secondary|Perceived Exertion|The amount of perceived exertion was reported for each of the 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), by 20 subjects, totaling 240 data points. This was measured using the TheraBand(R) Resistance Intensity Scale for Exercise (RISE Scale). Participants were asked to rate their perceived exertion on a scale of 0 to 10, 0 being no resistance and 10 being maximum resistance. The results of the 20 subjects were averaged for each exercise at each time point.|Perceived Exertion|||units on a scale, from 0 to 10||Full Range|Mean
7448|NCT02122445|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.|% Maximal Voluntary Isometric Contracion (%MVIC)|||% of Max Voluntary Isometric Contraction||Full Range|Mean
7451|NCT02121860|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose|||RLU||Inter-Quartile Range|Median
23686|NCT01706588|Secondary|Postsurgical Extra-oral Swelling||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery||||||
7454|NCT02121847|Secondary|Change From Baseline in Conjunctival Redness in the Worse Eye|Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
7455|NCT02121847|Secondary|Change From Baseline in the Interblink Interval in the Worse Eye|The interblink interval measures the time (seconds) between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Seconds||Standard Deviation|Mean
7456|NCT02121847|Secondary|Change From Baseline in Tear Film Break-up Time in the Worse Eye|TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Seconds||Standard Deviation|Mean
7457|NCT02121847|Secondary|Change From Baseline in Ocular Discomfort on a 4-point Scale|Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6|||Scores on a Scale||Standard Deviation|Mean
7458|NCT02121847|Secondary|Change From Baseline in OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
7459|NCT02121847|Primary|Change From Baseline in Font Size|The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Size||Standard Deviation|Mean
7460|NCT02121847|Primary|Change From Baseline in Words Read Incorrectly|The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Words||Standard Deviation|Mean
7461|NCT02121847|Primary|Change From Baseline in Reading Rate|Reading speed is assessed as the number of words read correctly in 2 minutes.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Words/Minute||Standard Deviation|Mean
7462|NCT02121847|Primary|Change From Baseline in Watching TV on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
7463|NCT02121847|Primary|Change From Baseline in Working With a Computer or Bank Machine on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
7464|NCT02121847|Primary|Change From Baseline in Driving at Night on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure||Scores on a Scale||Standard Deviation|Mean
7465|NCT02121847|Primary|Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
7466|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye|Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
8099|NCT02104830|Secondary|The Incidence of Severe Neutropenia (Grade 3-4)||16 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||participants|||Number
7467|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye|Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
7468|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye|Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
7469|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye|Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug||Scores on a Scale||Standard Deviation|Mean
7470|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96||||||
7471|NCT02121795|Secondary|Percent Change From Baseline in Hip and Spine BMD at Week 96||Baseline; Week 96||||||
7472|NCT02121795|Secondary|Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis||Week 96||||||
7473|NCT02121795|Secondary|Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis||Week 96||||||
7474|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.||cells/μL||Standard Deviation|Mean
7475|NCT02121795|Secondary|Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis||Week 48|Full Analysis Set||percentage of participants|||Number
7476|NCT02121795|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
7477|NCT02121795|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Hip DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.||percentage of change in hip BMD (g/cm^2)||Standard Deviation|Mean
7478|NCT02121795|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis||Week 48|Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug||Percentage of participants|||Number
7479|NCT02121522|Secondary|Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29|Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing.|Baseline and day 29|Treated set (OC). Observed Case (OC): This method analysed only available data that were observed while patients were on treatment, ie., missing data were not imputed.||mm²||Standard Deviation|Mean
7480|NCT02121522|Primary|Change From Baseline in CRT as Measured by SD-OCT on Day 29|Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.|Baseline (day 1) and day 29|Treated set (WOCF). Missing values are imputed by the worst observation carried forward (WOCF) measurement (including baseline).||μm||Standard Deviation|Mean
7481|NCT02121509|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
7482|NCT02121509|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
8514|NCT02092168|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration|AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration|Day 1 and Day 7|||ng.h/mL||Standard Deviation|Mean
7483|NCT02121509|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
7484|NCT02121509|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
7485|NCT02121509|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
7486|NCT02121509|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS1500 Fast and PKS1500 Fed, included all treated subjects in Part 1 and Part 2, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
7487|NCT02121483|Secondary|Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake|"Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1).~For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as fixed effect and ‘MDG at baseline’ as continuous covariate.~Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with plasma glucose profile data on both visits||mg/dL||Standard Error|Mean
7488|NCT02121483|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake|"Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake.~For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘FPG at baseline’ as continuous covariate.~Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with FPG data on both visits||mg/dL||Standard Error|Mean
7489|NCT02121483|Secondary|Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake|"Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake.~For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘UGE at baseline’ and ‘FPG at baseline’ as continuous covariates. Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with UGE data on both visits||g/24h||Standard Error|Mean
7490|NCT02121483|Primary|t1/2|Terminal half-life in plasma (t1/2).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||hours||Geometric Coefficient of Variation|Geometric Mean
7491|NCT02121483|Primary|Tmax|Maximum measured concentration in plasma (tmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||hours||Full Range|Median
7492|NCT02121483|Primary|Cmax|Maximum measured concentration in plasma (Cmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
7493|NCT02121483|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
7688|NCT02117050|Secondary|Change From Baseline in Number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24||Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7494|NCT02121483|Primary|AUC0-inf|Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
7495|NCT02121041|Primary|24 Hour Blood Pressure Average at the End of 4 Month Participation.||Participants will be on study average of 4 months.|||mm Hg||Standard Deviation|Mean
7496|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – I Would Recommend This Product to Another Parent.|Questions were answered immediately post-treatment by participant’s caregiver. Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7497|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7498|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7499|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7500|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7501|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7502|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7503|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7504|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7505|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7506|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7729|NCT02114892|Primary|Total Insulin Secretion at Week 12.|The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||unitless||Standard Deviation|Mean
7507|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7508|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7509|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7510|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7511|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7512|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7513|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7514|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7515|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7516|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7517|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7518|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7519|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7520|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7521|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7522|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7523|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7524|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7525|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7526|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7527|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7528|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7529|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7530|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7531|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7567|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7532|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7533|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7534|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7535|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7536|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7537|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7538|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7539|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7540|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7541|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7542|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7543|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
8515|NCT02092168|Primary|Tmax - Time to Reach Cmax|Tmax - Time to reach maximum plasma concentration of BIA 9-1067|Day 1 and Day 7|||hours||Full Range|Median
8516|NCT02092168|Primary|Cmax - Maximum Plasma Concentration|Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067|Day 1 and Day 7|||ng/mL||Standard Deviation|Mean
7544|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7545|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7546|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7547|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7548|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7549|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7550|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7551|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7552|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Soft|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7553|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Healthy|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7554|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||participants|||Number
7555|NCT02120833|Secondary|Corneometer Measurement on Day 14 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
8539|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
7556|NCT02120833|Secondary|Corneometer Measurement on Day 7 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
7557|NCT02120833|Secondary|Corneometer Measurement on Day 3 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
7558|NCT02120833|Secondary|Corneometer Measurement on Day 2 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
7559|NCT02120833|Secondary|Corneometer Measurement on Day 1 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
7560|NCT02120833|Secondary|Corneometer Measurement on Day 0 – Post-Treatment - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3.|Baseline to Post -Treatment on Day 0|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||arbitrary units||Standard Deviation|Mean
7561|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7562|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7563|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7564|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7565|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7566|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7629|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate|Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of participant demographics could not be analyzed as the SVR24 rate was based on one participant.|||||
7568|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7569|NCT02120833|Primary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7570|NCT02120833|Primary|Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
7571|NCT02120443|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.|24 hours|Three participants were excluded for significant protocol deviations.||IV sites||95% Confidence Interval|Number
7572|NCT02120443|Secondary|Normal Tissue Yellow Notification Rate|The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method.|24 hours|Three participants were excluded due to significant protocol deviations.||yellow notifications per day||95% Confidence Interval|Mean
7573|NCT02120443|Primary|Normal Tissue Red Notification Rate|The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method.|24 hours|Three subjects were excluded from analysis due to significant protocol deviations.||red notifications per day||95% Confidence Interval|Mean
7574|NCT02120300|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)||Baseline; Weeks 12, 24, and Posttreatment Week 12|Participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
7575|NCT02120300|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)||Weeks 4, 8, 12, 16, 20, and 24|Only the participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
7576|NCT02120300|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
7577|NCT02120300|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
7578|NCT02120300|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
7579|NCT02120300|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
7580|NCT02120300|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
7581|NCT02120300|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
7582|NCT02120027|Secondary|Sustained Analysis of Response for Abdominal Pain AND Stool Consistency Over First 24-week Double-blind Treatment Period|Weekly response for abdominal pain intensity AND stool consistency over the first 24 weeks of treatment applying the 50% rule with at least 2 weeks of response in the last 4 weeks of treatment (week 21 to 24). The patient will be considered a weekly responder as defined for the primary endpoint.|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
8540|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
7583|NCT02120027|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over the First 24 Weeks of Treatment in at Least 50% of the Weeks (12 Out of 24)|"The patient was considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
7584|NCT02120027|Secondary|Weekly Response for Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient was considered a weekly stool consistency responder if she met the following criterion:~Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
7585|NCT02120027|Secondary|Weekly Response for Abdominal Pain Intensity Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:~Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
7586|NCT02120027|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:~Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline (patients reported their worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain);~Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline (patients reported their stool consistency response using the Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea)."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.||Participants|||Count of Participants
7587|NCT02119325|Secondary|Tmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
7588|NCT02119325|Secondary|AUC for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU*min/mL||Standard Deviation|Mean
7589|NCT02119325|Secondary|Cmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU/mL||Standard Deviation|Mean
7590|NCT02119325|Secondary|Tmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
7591|NCT02119325|Secondary|AUC for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU*min/mL||Standard Deviation|Mean
7592|NCT02119325|Secondary|Cmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||µIU/mL||Standard Deviation|Mean
8541|NCT02091414|Secondary|Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
7593|NCT02119325|Secondary|Tmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
7594|NCT02119325|Secondary|AUC for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole*min/L||Standard Deviation|Mean
7595|NCT02119325|Secondary|Cmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole/L||Standard Deviation|Mean
7596|NCT02119325|Secondary|Tmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
7597|NCT02119325|Secondary|AUC for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole*min/L||Standard Deviation|Mean
7598|NCT02119325|Secondary|Cmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mmole/L||Standard Deviation|Mean
7599|NCT02119325|Secondary|Tmax for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
7600|NCT02119325|Secondary|AUC for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg*min/dL||Standard Deviation|Mean
7601|NCT02119325|Secondary|Cmax for Triglyceride in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
7602|NCT02119325|Secondary|Tmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||minutes||Standard Deviation|Mean
7603|NCT02119325|Secondary|AUC for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg*min/dL||Standard Deviation|Mean
7731|NCT02114892|Primary|Systolic Blood Pressure at Week 12.|The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mmHg||Standard Deviation|Mean
7604|NCT02119325|Secondary|Cmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
7605|NCT02119325|Primary|Cmax for Triglyceride in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
7606|NCT02119325|Primary|Cmax for Glucose in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.||mg/dL||Standard Deviation|Mean
7607|NCT02119286|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
7608|NCT02119286|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
7609|NCT02118961|Secondary|Percentage of Participants With Adverse Events||28-42 days following vaccination|||percentage of participants|||Number
7610|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||titer ratio||95% Confidence Interval|Geometric Mean
7611|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination|||titer ratio||95% Confidence Interval|Geometric Mean
7612|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies||28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||EU/mL||95% Confidence Interval|Geometric Mean
7613|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies||28-42 days after vaccination|||IU/mL||95% Confidence Interval|Geometric Mean
7614|NCT02118961|Secondary|Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 10 EU/mL.|28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||percentage of Participants||95% Confidence Interval|Number
7615|NCT02118961|Secondary|Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.|28-42 days after vaccination|||percentage of Participants||95% Confidence Interval|Number
7616|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies|Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.|pre-vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.||percentage of Participants||95% Confidence Interval|Number
7617|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies|Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.|pre-vaccination and 28-42 days after vaccination|||percentage of Participants||95% Confidence Interval|Number
7730|NCT02114892|Primary|First Phase of Insulin Secretion at Week 12.|The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||unitless||Standard Deviation|Mean
7618|NCT02118896|Post-Hoc|Efficacy Failure|Efficacy failure was defined as BCAR, graft loss, death, or an unknown outcome at the end of the study period. Start, event and censor times for the Kaplan-Meier analyses of efficacy failure were (Event time: onset of first episode of BCAR, graft loss, or death after study start, Censor Time: day of withdrawal (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study). No Kaplan-Meier estimates for PMR-EC-1210 due to the short subject participation period and the low number of subjects|Up to 5.75 years ((69 months (phase II) and 33 months (phase III)).|The study analysis population for this endpoint consisted of participants with efficacy failure.||participants with efficacy failure|||Number
7619|NCT02118896|Secondary|Number of Participants With Adverse Events|An AE was defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have a causal relationship with treatment. An AE was, therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the study drug, whether or not related to the study drug. Causally-related is defined as a highly probably, probably, possible, not assessable or missing relationship as assessed by the investigator. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life threatening: did not refer to event which hypothetically might have caused death if more severe); resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; required inpatient hospitalization/led to prolongation of hospitalization (treatment/observation/examination caused by AE was considered serious); other medically important events.|From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).|FAS population.||participants with adverse events|||Number
7620|NCT02118896|Secondary|Time to First BCAR Episode|The time to first acute rejection episode was defined as the number of days from day 1 (defined as the day of study enrollment) to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.|Up to 1344 days (3.75 years).|The study analysis population for this endpoint consisted of subjects with biopsy confimed acute rejection.||days||Standard Deviation|Mean
7621|NCT02118896|Secondary|Biopsy-confirmed Acute Rejection (BCAR) Episodes|FAS population. Evaluation of biopsy specimens performed by local histopathologist following “Histological Grading of Biopsies for Rejection” using grading relevant to type of organ allograft. Spontaneously resolving AR defined as episode not treated with new/increased corticosteroid medication, antibodies/any other medication and resolved irrespective of any MR4/MMF/azathioprine dose changes; corticosteroid sensitive AR was an episode which was treated with new/increased corticosteroid medication only and resolved, irrespective of any MR4, MMF or azathioprine dose changes; corticosteroid resistant AR was an episode which did not resolve following treatment with corticosteroids, if it was not treated with corticosteroids first but only with antibodies, it was included in this category; corticosteroid resistant AR episodes were further classified into episodes which resolved with further treatment and those which did not respond to further treatment/were ongoing at EOS/withdrawal.|Up to 6 years.|FAS population.||participants with with BCAR episodes|||Number
7622|NCT02118896|Primary|Graft Survival|Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood’s formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).|Study analysis population for this primary endpoint consisted of the FAS.||survival probability||95% Confidence Interval|Number
7623|NCT02118896|Primary|Participant Survival|Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood’s formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years (66 months (phase II) and 24 months (phase III)).|The population for analysis was the Full Analysis Set (FAS) which included all subjects who received at least one dose of study drug, MR4, while participating in one of the phase II Pharmacokinetics (PK) or phase III studies and at least one dose of MR4 during this study.||survival probability||95% Confidence Interval|Number
7624|NCT02118831|Secondary|Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)|Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).|baseline and month 4|||pg/mL||95% Confidence Interval|Mean
7625|NCT02118831|Primary|Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses|Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.|Up to 4 months|||nM||Standard Deviation|Mean
7626|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)|Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.|Up to 72 weeks|Predictive values of previous virological response could not be analyzed as the SVR24 rate was based on one participant.|||||
7627|NCT02118597|Secondary|Predictive Value of HCV Disease Characteristics|HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.|Screening (before Week 1)|Predictive values of HCV disease characteristics could not be analyzed as the SVR24 rate was based on one participant.|||||
7628|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Liver Fibrosis|The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of sub-categories of liver fibrosis could not be analyzed as the SVR24 rate was based on one participant.|||||
7630|NCT02118597|Secondary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 72 weeks|ITT population included all enrolled participants.||participants|||Number
7631|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation|Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.||participants|||Number
7632|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation Due to Futility|Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.||participants|||Number
7633|NCT02118597|Secondary|Number of Participants With Virological Relapse|Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.|Week 49 up to Week 72|ITT population included all enrolled participants.||participants|||Number
7634|NCT02118597|Secondary|Number of Participants With Virological Breakthrough|Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.|Up to Week 48|ITT population included all enrolled participants.||participants|||Number
7635|NCT02118597|Secondary|Percentage of Participants With Virological Response|Virological response is defined as HCV RNA <15 IU/mL.|Weeks 4, 8, 12, and 24|Intent to treat (ITT) population included all enrolled participants. Here, 'n' indicated number of participants with virological response data at evaluated time points.||percentage of participants|||Number
7636|NCT02118597|Primary|Sustained Virological Response 24 (SVR24) Rate|The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.|24 weeks after end of treatment (EOT) at Week 72|Due to the early termination of the study follow-up of the vast majority of the participants was not possible and data were not collected. Therefore, results for this outcome measure are based on one participant.||percentage of participants|||Number
7637|NCT02118441|Secondary|Complication Rate (Hematoma)|A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization|up to 5 minutes|||percentage of participants|||Number
7638|NCT02118441|Secondary|Number of Re-directions|A re-direct was defined as the needle being purposefully withdrawn at least 5 mm and re-directed (but not removed from the skin entirely).|up to 5 minutes|||number of re-directs||Inter-Quartile Range|Median
7639|NCT02118441|Secondary|Number of Attempts|An attempt was defined as a new purposeful penetration of the skin with the needle (i.e., following complete withdrawal of the needle from the skin).|up to 5 minutes|||number of attempts||Inter-Quartile Range|Median
7640|NCT02118441|Primary|Time to Successful Radial Arterial Catheterization|The time to successful radial arterial catheterization was defined as time zero to time of placement. Time zero for the DP group began when the anesthesiologist’s fingers were placed on the patient with the purpose of palpating the artery. Time zero for the US group began when the US transducer was first placed on the patient’s skin for the purpose of identifying the radial artery. Time to placement was defined as the interval from time zero until the time at which an arterial tracing was viewed on the monitor.|up to 5 minutes|||seconds||Inter-Quartile Range|Median
7641|NCT02117687|Secondary|Study Product Use|The number of times the study product is administered per day is recorded.|Day 8, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Number of Times/Day||Standard Deviation|Mean
7642|NCT02117687|Secondary|Conjunctival Hyperaemia in the Study Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
7643|NCT02117687|Secondary|Change From Baseline in Conjunctival Staining in the Study Eye|The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
7644|NCT02117687|Secondary|Change From Baseline in Corneal Staining in the Study Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
7689|NCT02117050|Secondary|Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24|WPAI-GH questionnaire is a subject reported quantitative assessment of general health conditions on productivity. The Total WPAI-GH score assessment was to be done on an 11-point scale ranging 0 to 10, with 0 indicating that health problems had no effect on work and 10 indicating that health problems completely prevented from working.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7645|NCT02117687|Secondary|Work Productivity and Activity Impairment Questionnaire Score|The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, who did not adhere to a pre-defined list of protocol violation criteria, and who had data for this data point||Scores on a Scale||Standard Deviation|Mean
7646|NCT02117687|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Seconds||Standard Deviation|Mean
7647|NCT02117687|Secondary|Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale|Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).|Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
7648|NCT02117687|Secondary|Subject Assessment of Treatment Acceptability on a 5-Point Scale|Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).|Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
7649|NCT02117687|Secondary|Subject Global Assessment of Treatment Efficacy on a 5-Point Scale|Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
7650|NCT02117687|Secondary|Subject Assessment of Dry Eye Symptoms on a 5-Point Scale|Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Subjects|||Number
7651|NCT02117687|Secondary|Change From Baseline in the Schirmer Test in the Study Eye|The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Millimeters (mm)/5 Minutes||Standard Deviation|Mean
7652|NCT02117687|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. Scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement and a positive number change from baseline represents a worsening.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
7653|NCT02117687|Secondary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
7654|NCT02117687|Primary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria||Scores on a Scale||Standard Deviation|Mean
7712|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA levels <LLoQ 24 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 36|The FAS consists of all randomized participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
7655|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 65 to 85 who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
7656|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
7657|NCT02117570|Primary|Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
7658|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
7659|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
7660|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
7661|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine.||Percentage of participants||95% Confidence Interval|Number
7669|NCT02117544|Secondary|Low Contrast Visual Acuity (LCVA) Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
7662|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine||Participants||95% Confidence Interval|Number
7663|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
7664|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
7665|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
7666|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.||Percentage of participants||95% Confidence Interval|Number
7667|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine||Percentage of participants||95% Confidence Interval|Number
7668|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days after Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine||Percentage of participants||95% Confidence Interval|Number
7687|NCT02117050|Secondary|Annualized Relapse Rate (ARR)|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Episodes indicated by neurologist as “relapse” in the subjects chart were to be recorded.|Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7670|NCT02117544|Secondary|HCVA Intermediate Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
7671|NCT02117544|Secondary|HCVA Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
7672|NCT02117544|Primary|High Contrast Visual Acuity (HCVA) Near Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).||logMAR|Participants|Standard Error|Least Squares Mean
7673|NCT02117414|Secondary|Atrial Sensing Amplitude|Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.|MRI/waiting visit to 1-month post-MRI/Waiting visit|Only subjects with measured atrial sensing amplitude values at both the pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.||Successful participants|||Number
7674|NCT02117414|Secondary|Atrial Pacing Capture Threshold (APCT)|Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid APCT measurements pre-MRI/waiting period and post-MRI/waiting period.||Successful participants|||Number
7675|NCT02117414|Secondary|Superior Vena Cava (SVC) Defibrillation Impedance|Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured SVC defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.||Successful participants|||Number
7676|NCT02117414|Secondary|RV Defibrillation Impedance|Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured RV defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an RV defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.||Successful participants|||Number
7677|NCT02117414|Secondary|System-related Complications|Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.|Implant to 4 months post-implant|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.||Successful participants|||Number
7678|NCT02117414|Primary|Ventricular Sensing Amplitude (R-wave)|Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.||Successful participants|||Number
7679|NCT02117414|Primary|Ventricular Pacing Capture Threshold (VPCT)|Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid VPCT measurements pre-MRI/waiting period and post-MRI/waiting period.||Successful participants|||Number
7680|NCT02117414|Primary|MRI-related Events|Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.|MRI procedure to 1-month post-MRI|A total of 156 subjects underwent an MRI scan at the MRI/waiting period visit; of them 147 were followed through the one month post-MRI visit or later and are included in the analysis.||Participants free of MRI-related events|||Number
7681|NCT02117193|Secondary|Breath Alcohol||6 months||||||
7682|NCT02117193|Secondary|Profile of Mood States||6 months||||||
7683|NCT02117193|Secondary|Hydration Status|Urine Specific Gravity|After each sequence, up to 8 hours|||g/ml||Standard Deviation|Mean
7684|NCT02117193|Primary|Biochemical Responses|Glucose after each situation in the morning|After each sequence, up to 8 hours|||mg/dl||Standard Deviation|Mean
7685|NCT02117193|Primary|Neuromuscular Performance|knee extensor isometric torque|After each sequence, up to 8 hours|||Nm||Standard Deviation|Mean
7686|NCT02117193|Primary|Aerobic Performance|Aerobic performance will be determined through the subject's heart rate|After each sequence, up to 8 hours|||bpm||Standard Deviation|Mean
7806|NCT02111252|Secondary|GMT of Single Radial Hemolysis (SRH) Antibody Titer|GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.||mm^2||95% Confidence Interval|Geometric Mean
7690|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects, convenience and global satisfaction sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects, convenience and global satisfaction, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7691|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects and convenience sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects and convenience, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7692|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24|The TSQM (Version II) is an 11-item validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Total TSQM score was the average of individual sub-scale scores (effectiveness, side effects, convenience and global satisfaction) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12 and Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7693|NCT02117050|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24|The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. MSQoL-54 is a 54 item questionnaire which covers 12 sub-scales along with two summary scores, and two additional single-item measures. The 12 sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The 2 summary scores are the physical health composite summary and the mental health composite summary. The 2 additional single item measures are satisfaction with sexual function and change in health. Each of the 12 sub-scale scores, the 2 summary scores and 2 single item measures were to be converted into an overall Total Score ranging from 0-100, where higher scores indicated better health status.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7694|NCT02117050|Secondary|Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24|PDDS questionnaire was to be used to assess the walking ability of subjects. Subjects were to describe their walking ability on scale ranging from 0 to 8, where 0 indicated normal walking and 8 indicated subject’s condition as bedridden. Lesser score indicated better walking ability.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.|||||
7695|NCT02117050|Primary|Change From Baseline in Treatment Satisfaction Score Determined by the Global Satisfaction Sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Global satisfaction sub-scale of TSQM was to be used to measure overall satisfaction with medication using a 100-point scale. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for primary endpoint was not collected.|||||
7696|NCT02115984|Primary|The Quantity of Leukocytes and Neutrophils in the Blood of Patients||Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)|||10^9 cells/L||Inter-Quartile Range|Median
7697|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline|Day 8|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.||percentage of participants||95% Confidence Interval|Number
7698|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."||fold rise||95% Confidence Interval|Geometric Mean
7699|NCT02115815|Secondary|Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Baseline (Day 1), Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."||spot forming counts per 10^6 PBMCs||95% Confidence Interval|Geometric Mean
7700|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.||percentage of participants||95% Confidence Interval|Number
7701|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||fold rise||95% Confidence Interval|Geometric Mean
7702|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||titer||95% Confidence Interval|Geometric Mean
7703|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.||percentage of participants||95% Confidence Interval|Number
7704|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||fold rise||95% Confidence Interval|Geometric Mean
7705|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."||titer||95% Confidence Interval|Geometric Mean
7706|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving investigational product and was assessed by investigator as medically significant.|From Day 1 to Day 361|As-treated Population (ATP) included participants who received any study investigational product.||participants|||Number
7707|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state.|From Day 1 to Day 28|As-treated Population (ATP) included participants who received any study investigational product.||participants|||Number
7708|NCT02115815|Primary|Number of Participants With Solicited Symptoms|Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (>=) 100.4 degrees F by any route from Day 1 to Day 7.|Day 1 to Day 7|As-treated Population (ATP) included participants who received any study investigational product.||participants|||Number
7709|NCT02115581|Primary|Improvement in Left Ventricular Filling Abnormality|Doppler-derived transmitral blood flow and pulmonary venous blood flow data were used for grading of the severity of diastolic filling abnormality in patients before and after the intervention. Diastolic filling abnormality was categorized as: 1- normal 2- abnormal relaxation 3- pseudonormal 4- restricted pattern based on echo data. The proportion of patients who showed improvement in the diastolic function grading was compared between the study groups.|6 months|||Percentage|||Number
7710|NCT02115581|Primary|Improvement in Left Ventricular Ejection Fraction|Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography|6 months|||Percentage||Standard Deviation|Mean
7711|NCT02115581|Secondary|Adverse Events|Number of patients with evidence of adverse reaction to coenzyme Q10 including nausea, vomiting, changes in blood pressure, neurological signs or any abnormal behavior like disquiet in young children.|6 months|||Participants|||Number
7807|NCT02111252|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer|Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination|Day 22|The full analysis set was used.||titer||95% Confidence Interval|Geometric Mean
7713|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA levels <LLoQ 4 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 16|The FAS consists of all randomized participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
7714|NCT02115321|Secondary|Percentage of Participants With HCV RNA <LLoQ at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Weeks 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.|||||
7715|NCT02115321|Secondary|Percentage of Participants With HCV RNA Undetectable at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.|||||
7716|NCT02115321|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores in CP-B Participants|The MELD score provides an objective and granular assessment of liver improvement as a continuous variable. The calculation of MELD score is based on three biochemical variables (serum bilirubin, creatinine and international normalized ratio [INR] of prothrombin time). The MELD equation is as follows: 9.57 x ln(creatinine mg/dL) +3.78 x ln(bilirubin mg/dL) +11.2 x ln (INR) + 6.43. Scores are multiplied by 10 and rounded to the nearest whole number and range from 6 (less ill) to 40 (gravely ill). MELD scores were determined at Baseline (Day 1) and again at Week 12, Follow-up (FU) Week 12 (Week 24), and FU Week 24 (Week 36). Change from baseline in MELD score = Post-baseline MELD score - baseline MELD score.|Baseline and Weeks 12, 24, and 36|All CP-B participants in the FAS (all randomized participants who received at least one dose of study medication) with available data.||Units on a scale||Standard Deviation|Mean
7717|NCT02115321|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|The APaT population consisted of all randomized participants who received at least one dose of study medication.||Number of participants|||Number
7718|NCT02115321|Primary|Number of Participants Experiencing an Adverse Event (AE) During Treatment and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 weeks|The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one dose of study medication.||Number of participants|||Number
7719|NCT02115321|Primary|Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 24|The Full Analysis Set (FAS) consists of all randomized participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
7720|NCT02114892|Primary|Diastolic Blood Pressure at Week 12|The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mmHg||Standard Deviation|Mean
7721|NCT02114892|Primary|Waist Circumference at Week 12|Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||cm||Standard Deviation|Mean
7722|NCT02114892|Secondary|Uric Acid at Week 12.|The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12|Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||µmol/l||Standard Deviation|Mean
7723|NCT02114892|Secondary|Creatinine at Week 12.|The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12|Baseline. Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||µmol/l||Standard Deviation|Mean
7724|NCT02114892|Secondary|Low Density Lipoproteins (c-LDL) at Week 12|The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
7725|NCT02114892|Secondary|Total Cholesterol at Week 12|The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
7726|NCT02114892|Secondary|Body Mass Index at Week 12|The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||kg/m2||Standard Deviation|Mean
7727|NCT02114892|Secondary|Weight at Week 12.|The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||kg||Standard Deviation|Mean
7728|NCT02114892|Primary|Total Insulin Sensitivity at Week 12.|The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||unitless||Standard Deviation|Mean
7732|NCT02114892|Primary|Fasting Glucose Levels at Week 12.|The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mmol/L||Standard Deviation|Mean
7733|NCT02114892|Primary|High Density Lipoprotein (c-HDL) Levels at Week 12.|The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
7734|NCT02114892|Primary|Triglycerides Levels at Week 12|The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)||mg/dL||Standard Deviation|Mean
7735|NCT02114268|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.|Predose and Day 15, 31, 91, 181, 271 and 361|The As-treated Population included participants who receive any study investigational product.||participants|||Number
7736|NCT02114268|Secondary|Volume of Distribution (Vz) for MEDI8897|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||milliliter (ml)||Standard Deviation|Mean
7737|NCT02114268|Secondary|Systemic Clearance (CL) for MEDI8897|Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||ml per day||Standard Deviation|Mean
7738|NCT02114268|Secondary|Terminal Phase Elimination Half Life (t1/2) for MEDI8897|The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||Day||Standard Deviation|Mean
7739|NCT02114268|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897|The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||Day*microgram per milliliter||Standard Deviation|Mean
7740|NCT02114268|Secondary|Maximum Observed Serum Concentration (Cmax) for MEDI8897|The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
7741|NCT02114268|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897|The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.||Day||Standard Deviation|Mean
7742|NCT02114268|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.|From start of study drug administration up to Day 391 (Day 361 +/- 30 days)|The As-treated population included participants who receive any study investigational product.||participants|||Number
7840|NCT02108977|Primary|Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment|Subjects will be asked 8 True/False genetics-related questions before and after counseling to assess improvement and retention of genetic counseling knowledge and information|Pre- and post- (within 2 weeks) genetic counseling|||Number of correct answers (out of 8)||Standard Deviation|Mean
7743|NCT02114216|Secondary|PAR2 and IL-8 Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers’ instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks|||Fold change||Standard Error|Mean
7744|NCT02114216|Primary|TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers’ instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks|||Fold change||Standard Error|Mean
7745|NCT02114177|Secondary|Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale|"The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening."|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
7746|NCT02114177|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores|The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
7747|NCT02114177|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
7748|NCT02114177|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)|HCVSIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||units on a scale||Standard Error|Mean
7749|NCT02114177|Secondary|Percentage of Participants With Viral Relapse|Percentage of participants who did not achieve sustained virologic response 12, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of participants|||Number
7750|NCT02114177|Secondary|Percentage of Participants With Viral Breakthrough|Percentage of participants with greater than 1 log10 IU/mL increase in plasma Hepatitis C virus ribonucleic acid level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been less than 25 IU/mL.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants|||Number
7841|NCT02108691|Secondary|Changes in LDLc/HDLc|LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||ratio||Standard Deviation|Mean
7842|NCT02108691|Secondary|Changes in Non-HDLc|Non-HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||mg/dl||Standard Deviation|Mean
7751|NCT02114177|Secondary|Percentage of Participants Achieving a On-treatment Virologic Response|Ontreatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Day 14, Day 28, End of treatment (Week 8 or Week 12)|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of participants|||Number
7752|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|Participants considered to have achieved SVR24, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 24 weeks after the Actual end of study drug treatment.|24 weeks after the end of treatment (EOT) (Week 32 or Week 36)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
7753|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)|Participants considered to have achieved SVR4, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 4 weeks after the actual end of study drug treatment.|4 weeks after the end of treatment (EOT) (Week 12 or Week 16)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
7754|NCT02114177|Primary|Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.|12 weeks after the end of treatment (EOT) (Week 20 or Week 24)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
7755|NCT02114151|Secondary|Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants.|Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Participants|||Number
7756|NCT02114151|Secondary|Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24|"The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health)."|Baseline, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a Scale||Standard Error|Mean
7757|NCT02114151|Secondary|Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of Participants|||Number
7758|NCT02114151|Secondary|Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a Scale||Standard Error|Mean
7759|NCT02114151|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12|The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline, Week 4, Week 12 and Follow-Up Week 12|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a Scale||Standard Error|Mean
7760|NCT02114151|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period.|During the Follow-up (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
7761|NCT02114151|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL).|Up to End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants|||Number
7762|NCT02114151|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|Intent-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Percentage of Participants|||Number
7763|NCT02114151|Secondary|Percentage of Participants With On-treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Week 2, 4 and End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of Participants|||Number
7764|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment.|Week 36|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants||95% Confidence Interval|Number
7765|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment.|Week 16|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants||95% Confidence Interval|Number
7766|NCT02114151|Primary|Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment.|Week 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.||Percentage of Participants||95% Confidence Interval|Number
7767|NCT02113579|Secondary|Global Subjective VAS Score at Week 4|At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:“Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.” The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
7768|NCT02113579|Secondary|Global Subjective VAS Score at Week 2|At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:“Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.” The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
7769|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
7770|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
7843|NCT02108691|Secondary|Changes in LDLc|LDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||mg/dl||Standard Deviation|Mean
7844|NCT02108691|Secondary|Changes in BMI(Body Mass Index)|BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).|8 weeks|||kg/m^2||Standard Deviation|Mean
7771|NCT02113579|Secondary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||percentage of participants|||Number
7772|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||grams||Standard Error|Least Squares Mean
7773|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
7774|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||grams||Standard Error|Least Squares Mean
7775|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.||units on a scale (mm)||Standard Error|Least Squares Mean
7776|NCT02113579|Primary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|4 Weeks|Analysis was based on Full Analysis Set, which included all randomized subjects.||percentage of participants|||Number
7777|NCT02113449|Primary|Provide a Score From 1-7 to Some Statements, Depending on How Much You Think Each Statement Applies or Does Not Apply to the Spray Product That You Used|A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it. You can use any score from 1 to 7 to indicate how much or how little you think the statement applies to this product|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7778|NCT02113449|Primary|How Often do You Think This Spray Product Would Last for You Personally?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7779|NCT02113449|Primary|Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7780|NCT02113449|Primary|How Many Packages Would You Buy?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience.This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7845|NCT02108691|Secondary|Changes in Weight|Weight was measured in study visit 1(0 week)and visit 3(8 week).|8 weeks|||kg||Standard Deviation|Mean
7846|NCT02108691|Secondary|Changes in Percent Body Fat|Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks|||percentage||Standard Deviation|Mean
7781|NCT02113449|Primary|If the Product You Just Tried (After At-home Use) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7782|NCT02113449|Primary|Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option. It was done to compare the spray with the product selected by the participant in Q1. There were 11 points between the two products that participants could divide anyways thet wanted (11-0, 10-1, 9-2, 8-3, 7-4 or 6-5 etc). The more the participant liked a product compared to other, the higher the number of points were to be given to that product.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7783|NCT02113449|Primary|Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7784|NCT02113449|Primary|Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7785|NCT02113449|Primary|If the Product You Just Tried (After First Dose) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7786|NCT02113449|Primary|Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first use. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7787|NCT02113449|Primary|Which One Product That Relieves Nasal Congestion do You Buy Most Often?|"There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked as part of screening survey prior to concept viewing. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that didnot perform well), and therefore 133 participants were included in PP population.||Participants|||Number
7788|NCT02113124|Primary|Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating|5 ml of blood will be acquired following a 8-hour fasting period to determine baseline concentrations of amino acids. A meal will then be provided and another blood sample will be acquired 90 minutes after completing the meal to examine the change in amino acid concentration. These samples will be used to determine the levels of each essential amino acid present.|Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal|||µM||Standard Error|Mean
7789|NCT02113007|Secondary|Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.|Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.|up to 4 weeks|||participants|||Number
7790|NCT02113007|Secondary|Progression Free Survival (PFS)|Six and twelve-month CNS progression-free survival rate.|6 and 12 months|The study closed early due to slow accrual; outcome measure not reached.|||||
7791|NCT02113007|Primary|Overall Response Rate|Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.|approximately 32 weeks|The study closed early due to slow accrual. This outcome measure was not reached.|||||
7792|NCT02111603|Secondary|Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA)|"Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Relative composition of the main individual bile acids (cholic acid (CA), chenodeoxycholic acid (CDCA), deoxycholic acid (DCA), lithocholic acid (LCA) and ursodeoxycholic acid (UDCA)) in 48 hour stool collection after colesevelam treatment were compared to baseline values.~The concordance correlation coefficient (rc) measures agreement between two variables. The concordance correlation satisfies -1 ≤ rc ≤ +1. A value of rc = +1 corresponds to perfect agreement. A value of rc = -1 corresponds to perfect negative agreement, and a value of rc = 0 corresponds to no agreement."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||concordance correlation coefficient||Standard Error|Mean
7793|NCT02111603|Secondary|Change in Stool Frequency (Number of Stools Per Week)|Change in stool frequency from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||Number of stools per week||Standard Error|Mean
7794|NCT02111603|Secondary|Change in Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Form Scale. The Bristol Stool Form Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||units on a scale||Standard Error|Mean
7795|NCT02111603|Secondary|Change in Fecal Fat Excretion|Change in fecal fat excretion from baseline in response to treatment with colesevelam|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||g/day||Standard Error|Mean
7796|NCT02111603|Secondary|Change in Fasting Serum C4|Change in fasting serum C4 from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||ng/mL||Standard Error|Mean
7797|NCT02111603|Primary|Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam|Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.||uM||Standard Error|Mean
7798|NCT02111369|Primary|Change in Acoustic Spectrograms|"Objective Voice Assessment~• Using the Computerized Speech Laboratory speech and voice analysis system (KayPENTAX, Montvale, NJ)"|baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.|||||
7799|NCT02111369|Primary|Change in Global Voice Rating|"Patient-Reported Measure~• 0-7 ranking"|Baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.|||||
7800|NCT02111369|Primary|Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score|"The CAPE-V is a clinically validated perceptual voice assessment tool that is used to describe the severity of auditory-perceptual attributes of a voice problem, in a way that can be communicated among clinicians. Participant's speech is recorded and evaluated by trained listeners. Listeners indicate overall tremor severity by making a tick mark on a 1 to 100 mm visual analog scale. Total scores range from 0 to 100 where 0 is the best score and 100 is the worst score."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).||units on a scale||Standard Deviation|Mean
7801|NCT02111369|Primary|Change in Voice-Related Quality Of Life (VRQOL) Questionnaire Score|"The VRQOL is a ten question self-reported measure that asks patients to rate responses from 1-5 (1=none, not a problem, 2=a small amount, 3=a moderate (medium) amount, 4=a lot, 5=problem is as bad as it can be). Total scores range from 0 to 100. A higher score indicates more problems interfering with day to day activities."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).||units on a scale||Standard Deviation|Mean
7802|NCT02111369|Primary|Change in Quality of Life in Essential Tremor (QUEST) Questionnaire Score|The QUEST questionnaire is a 30 item self-reported essential tremor-specific quality of life scale that asks participants to rate responses (never/no, rarely, sometimes, frequently, always/yes, or not applicable). Total scores range between 0 to 100 where 0 is the best score and 100 is the worst score. A higher score indicates a lower quality of life.|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).||units on a scale||Standard Deviation|Mean
7803|NCT02111252|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer|Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22|||Fold Change||95% Confidence Interval|Geometric Mean
7804|NCT02111252|Secondary|Seroconversion Rate of SRH Antibody Titer|Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|||percentage of participants||95% Confidence Interval|Number
7805|NCT02111252|Secondary|Seroprotection Rate of SRH Antibody Titer|Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.||percentage of participants||95% Confidence Interval|Number
7847|NCT02108691|Primary|Changes in Body Fat Mass|Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks|||g||Standard Deviation|Mean
7808|NCT02111252|Secondary|Change From Baseline in Safety Electrocardiogram (ECG) Parameters|The ECG data will be analyzed into 3 categories, `normal`, `abnormal but not clinically significant` and `abnormal clinically significant`. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).|Day 1 and Day 22|||participants|||Number
7809|NCT02111252|Secondary|Change From Baseline in Blood Pressure|For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.|Day 1 (Baseline), Day 8, Day 22|||mmHg||Standard Deviation|Mean
7810|NCT02111252|Primary|Geometric Mean Fold Increase in HI Antibody Titer|Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22|The full analysis set was used.||Fold Change||95% Confidence Interval|Geometric Mean
7811|NCT02111252|Primary|Seroconversion Rate of HI AntibodyTiter|Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22|||Percentage of participants||95% Confidence Interval|Number
7812|NCT02111252|Primary|Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer|Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22|The full analysis set was used.||Percentage of participants||95% Confidence Interval|Number
7813|NCT02111252|Primary|Number of Participants With Solicited Injection Site and Systemic Adverse Events|Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.|For 22 days|The safety analysis set, comprised the volunteers who received a single dose of 0.5 mL TAK-850, was used.||participants|||Number
7814|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Curve(AUC)||Zero to infinity [AUC(0-∞)]|All participants who had at least one study treatment and had evaluable PK data.||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
7815|NCT02111083|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.||hours||Geometric Coefficient of Variation|Geometric Mean
7816|NCT02111083|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
7817|NCT02111083|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|Day1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacodynamic(PD) data.||grams (g)||Geometric Coefficient of Variation|Geometric Mean
7818|NCT02111083|Secondary|Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PK data.||hours||Full Range|Median
7819|NCT02111083|Primary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)||Day 1, predose through 8 hours post dose in each period|All participants who had at least one study treatment and had evaluable PK data.||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
7820|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
7821|NCT02110238|Primary|WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.|Change from Baseline (CFB) over Weeks 3, 6, and 12|Per Protocol: All subjects with at least 1 post baseline primary outcome measure and no important protocol deviations.||millimeter||95% Confidence Interval|Least Squares Mean
7822|NCT02109731|Primary|Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG)|The pre-study AHI (before the NAP treatment was applied) was measured and quantified and compared to the post study AHI (after three months of NAP treatment) and the difference between pre and post therapy is reported. The AHI is an hourly rate of breathing disturbance (apneas and hypopneas per hour) that is calculated while subjects are evaluated during an overnight sleep study, with polysomnography applied (PSG). For example, while a subject is spending the night in the PSG laboratory sleeping, his/her breathing is evaluated for evidence of apneas and hypopneas during various stages of sleep. Sleep is measured with electroencephalography. And breathing is measure with respiratory excursions via chest/abdominal plethysmography recordings and airflow from the nose/mouth.|three months|subjects with a diagnosis of OSA||events per hour||Standard Deviation|Mean
7823|NCT02109497|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event||Up to 19 days after first dose of caffeine|Safety population||participants|||Number
7868|NCT02108288|Primary|Cmax of Latanoprost Acid||Day 1 and Day 7|||pg/mL||Standard Deviation|Mean
7869|NCT02108288|Primary|Cmax of Carteolol||Day 1 and Day 7|||ng/mL||Standard Deviation|Mean
7824|NCT02109497|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg|PK Per Protocol Population, as defined as all participants who received scheduled doses of both caffeine and PBT2 and had sufficient samples collected to determine PK parameters from plasma concentrations of caffeine on Day 1 and Day 12.|prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48 hours post each dose.|||ng*hr/mL||Standard Deviation|Mean
7825|NCT02109172|Primary|Weighted Mean (0-24hr) FEV1 (Forced Expiratory Volume in 1 Second)||Following the Day 7 AM dose|||mL||Standard Error|Least Squares Mean
7826|NCT02109159|Secondary|Number of Access to the Video Generated as a Result of Video Sharing by Each Participant|The distribution of the numbers of access to the video that each participant generated will be compared using the data collected with the computer programme to track access to the videos.|After 14 days of sending the online videos|||Number of views||95% Confidence Interval|Mean
7827|NCT02109159|Primary|Number of Participants Who Forwarded the Video|A computer programme to track the access to the videos has been made. The number of people who forwarded the video will be analysed based on the data collected with this programme.|After 14 days of sending the online videos|||participants|||Number
7828|NCT02109133|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 24hours after operation|||participants|||Number
7829|NCT02109133|Other Pre-specified|Post-operative Nausea||During 24hours after operation|||events|||Number
7830|NCT02109133|Secondary|Overall Surgical Condition|overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.|At the end of the Steep trendelenburg position, an average of 1 hour|||units on a scale||Inter-Quartile Range|Median
7831|NCT02109133|Primary|Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade|maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade|Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position|||mmHg||Standard Deviation|Mean
7832|NCT02109107|Secondary|Subject Satisfaction With Study Outcome Rating|At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?”, using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied|6 weeks|||participants|||Number
7833|NCT02109107|Secondary|Change in Body Mass Index (BMI)|Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.|Baseline and 6 weeks|||kg/m2||Standard Deviation|Mean
7834|NCT02109107|Secondary|Change in Body Weight|Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.|Baseline and 6 weeks|||pounds||Standard Deviation|Mean
7835|NCT02109107|Primary|Change in Combined Circumference Measurements|"Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success.~A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success."|Baseline and 6 weeks|||inches||Standard Deviation|Mean
7836|NCT02108977|Primary|Cost Analysis|Labor (including training) and non-labor (e.g., equipment cost) inputs required to provide counseling via telephone versus videoconferencing. Patient travels costs will be included via self-report.|Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)|||US Dollars||Full Range|Mean
7837|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS|Five counselors agreed to be interviewed. We asked them to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within 4 weeks after study data collection was completed||||||
7838|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS|We asked the subjects to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within six weeks of receiving genetic counseling|A subsample of patients in each modality was interviewed to qualitatively assess the satisfaction with the counseling they received, and the benefits and limitations of the modality, whether it was by phone or video.||participants|||Number
7839|NCT02108977|Primary|Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale|6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5)|Within two weeks of receiving genetic counseling|||points on a scale of 30 (most satisfied)||Standard Deviation|Mean
7870|NCT02108223|Secondary|Implantation Rates|Implantation rate is the percentage of embryos which successfully undergo implantation|up to 9 months|||percentage of embryo implantation|||Number
7848|NCT02108652|Secondary|Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab||Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.||percentage of participants|||Number
7849|NCT02108652|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)|Cohort 2 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.||mcg/mL||Standard Deviation|Mean
7850|NCT02108652|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)|Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.||microgram(s)/milliliter (mcg/mL)||Standard Deviation|Mean
7851|NCT02108652|Secondary|Percentage of Participants Alive at 1-year||1-year|Cohort 2 ITT Population||percentage of participants||95% Confidence Interval|Number
7852|NCT02108652|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to the time of death from any cause on study.|Baseline until death (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
7853|NCT02108652|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline until death (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||percentage of participants|||Number
7854|NCT02108652|Secondary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 objective response-evaluable population.||percentage of participants||95% Confidence Interval|Number
7855|NCT02108652|Secondary|PFS as Assessed by the Investigator According to Modified RECIST|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
7856|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||percentage of participants|||Number
7857|NCT02108652|Secondary|PFS as Assessed by the Investigator According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
7858|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||percentage of participants|||Number
7859|NCT02108652|Secondary|Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||months||95% Confidence Interval|Median
7871|NCT02108223|Secondary|Fertilization Rate|fertilization rate used to measure how many oocytes become fertilized by sperm cells|up to 9 month|||percentage of fertilized oocytes|||Number
7860|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 ITT population||percentage of participants|||Number
7861|NCT02108652|Secondary|Duration of Response as Assessed by the Investigator According to Modified RECIST|Duration of response was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 objective response-evaluable population.||months||Full Range|Median
7862|NCT02108652|Secondary|Duration of Response as Assessed by the Investigator According to RECIST v1.1|Duration of response was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 objective response-evaluable population.||months||Full Range|Median
7863|NCT02108652|Secondary|Duration of Response as Assessed by the IRF According to RECIST v1.1|Duration of response was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 objective response-evaluable population.||months||Full Range|Median
7864|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 objective response-evaluable population.||percentage of participants||95% Confidence Interval|Number
7865|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.|Baseline, every 9 weeks for the first 12 months, thereafter every 12 weeks until confirmed disease progression or death, whichever occurred first (data cutoff date 14 September 2015, up to maximum length of follow-up of 15.24 months)|Cohort 2 objective response-evaluable population included Intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 2 ITT population included all participants from Cohort 2 who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
7866|NCT02108288|Secondary|Tmax of Latanoprost Acid||Day 1 and Day 7|||min||Full Range|Median
7867|NCT02108288|Secondary|Tmax of Carteolol||Day 1 and Day 7|||h||Full Range|Median
7874|NCT02108223|Primary|Pregnancy Rate|percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)|Up to 9 month|In Group 1, transfer procedure could not be performed one patient. In Group 2, the cycle was cancelled in two patients. Oocyte could not be obtained in one patient during OPU. In other 2 patients, transfer couldn’t be done. In Group 3 transfer procedure could not be performed in one patient. The pregnancy rates per embryo transfer were calculated.||percentage of pregnant participants|||Number
7875|NCT02108171|Secondary|Perioperative Hypertonsion Episodes|Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.|1 day|||participant|||Number
7876|NCT02108171|Secondary|Perioperative Hypotension Episodes|Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.|1 day|||participant|||Number
7877|NCT02108171|Secondary|Perioperative Tachycardia Episodes|Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s.|1 day|||participant|||Number
7878|NCT02108171|Secondary|Perioperative Bradycardia Episodes|Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s.|1 day|||participant|||Number
7879|NCT02108171|Secondary|Number of Participants With Satisfaction Score <2|"Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU).~Satisfaction score <2 was considered to be better for the patient"|1 day|||participant|||Number
7880|NCT02108171|Secondary|Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine|Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine.|1 day|||mmHg||Standard Deviation|Mean
7881|NCT02108171|Secondary|Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine|"4-point anxiety score:~= combative~= anxious~= calm~= amiable. Anxiety score >2 was considered to be better for the preoperative patients."|1 day|||units on a scale||Inter-Quartile Range|Median
7882|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Dexmedetomidine (DEX) Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day|||units on a scale|||Number
7883|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Placebo Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day|||units on a scale|||Number
7884|NCT02108171|Other Pre-specified|Patients With Intra-operative Awareness in Two Groups|Patients With intra-operative awareness in Two Groups. patients receiving intranasal placebo or dexmedetomidine|1 day|||participants|||Number
7885|NCT02108171|Other Pre-specified|Patients With Postoperative Shivering in Two Groups|Patients With postoperative shivering in Two Groups. the occurrence of postoperative shivering|1 day|||participants|||Number
7886|NCT02108171|Other Pre-specified|Patients With Postoperative Vomiting in Two Groups|Patients With postoperative vomiting in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day|||participants|||Number
7887|NCT02108171|Other Pre-specified|Patients With Postoperative Nausea in Two Groups|Patients With postoperative nausea in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day|||participants|||Number
7888|NCT02108171|Other Pre-specified|Number of Participants With VAS >50|Patients with postoperative analgesia in two groups. analgesic requests within 2 h after extubation were recorded. An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day|||Number of Participants with VAS >50|||Number
7889|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group at Pre-induction|HR in the dexmedetomidine group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
7890|NCT02108171|Other Pre-specified|HR in the Placebo Group at Pre-induction|HR in the placebo group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
7891|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group Before Intranasal Drugs|HR in the dexmedetomidine group Before Intranasal Drugs . HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
7892|NCT02108171|Other Pre-specified|HR in the Placebo Group Before Intranasal Drugs|HR in the placebo group Before Intranasal Drugs HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day|||bpm|||Number
7893|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at extubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7894|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at extubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7906|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of propofol after intranasal placebo at extubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7895|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at emergence.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7896|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal placebo at emergence.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7897|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at return of spontaneous breathing.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7898|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal placebo at return of spontaneous breathing.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7899|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine on removal of operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7900|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo on removal of operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7901|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine before inserting operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7902|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo before inserting operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7903|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at tracheal intubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7904|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at tracheal intubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml–1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg–1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day|||ng/ml|||Number
7905|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at extubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7907|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at emergence.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7908|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of propofol after intranasal placebo at emergence.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7909|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at return of spontaneous breathing.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7910|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal placebo at return of spontaneous breathing.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||ug/ml|||Number
7911|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine on removal of operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7912|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo on removal of operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7913|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine before inserting operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7914|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo before inserting operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day|||µg/ml|||Number
7915|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at tracheal intubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml–1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml–1 at 2-min intervals to maintain the Narcotrend index between ‘D0’ and ‘E1’ until the end of surgery."|1 day|||µg/ml|||Number
7916|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal placebo at tracheal intubation.~Propofol was infused intraoperatively to a target-controlled infusion (TCI) plasma concentration of 2.5μg∙ml–1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml–1 at 2-min intervals to maintain the Narcotrend index between ‘D0’ and ‘E1’ until the end of surgery."|1 day|||µg/ml|||Number
7917|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Dexmedetomidine|Time to extubation of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and extubation|1 day|||minutes|||Number
7918|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Placebo|Time to extubation of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and extubation|1 day|||minutes|||Number
7919|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Dexmedetomidine|Time to consciousness of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and consciousness.|1 day|||minutes|||Number
7920|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Placebo|Time to consciousness of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and consciousness.|1 day|||minutes|||Number
7921|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Dexmedetomidine|Time to spontaneous breathing of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day|||minutes|||Number
7922|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Placebo|Time to spontaneous breathing of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day|||minutes|||Number
7923|NCT02108171|Secondary|Number of Participants With Anxiety Score >2|"satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction.~Anxiety score >2 was considered to be better for the patient."|1 day|||participant|||Number
7924|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Dexmedetomidine|Satisfaction scores of patients receiving intranasal dexmedetomidine. Satisfaction used a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day|||units on a scale|||Number
7925|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Placebo|Satisfaction scores of patients receiving intranasal placebo. satisfaction was assessed using a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day|||units on a scale|||Number
7926|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Anxiety score of Patients Receiving Intranasal dexmedetomidine at Pre-induction.~The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day|||units on a scale|||Number
7927|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo at Pre-induction|Anxiety score of Patients Receiving Intranasal Placebo at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day|||units on a scale|||Number
7928|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Anxiety score of Patients Receiving Intranasal dexmedetomidine Before Intranasal Drugs.~The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day|||units on a scale|||Number
7929|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|Anxiety score of Patients Receiving Intranasal Placebo Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day|||units on a scale|||Number
7930|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine After Extubation|"Modified OAA/S score of patients receiving intranasal dexmedetomidine after extubation.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
7931|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo After Extubation|"Modified OAA/S score of patients receiving intranasal placebo After extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
7932|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Modified OAA/S score of patients receiving intranasal dexmedetomidine at Pre-induction.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
7933|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo at Pre-induction|"Modified OAA/S score of patients receiving intranasal placebo at Pre-induction.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
7934|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal dexmedetomidine Before intranasal drugs Modified Observer’s Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
7935|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal placebo Before intranasal drugs Modified Observer’s Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day|||units on a scale|||Number
7936|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Dexmedetomidine|Duration of surgery of patients receiving intranasal dexmedetomidine. Duration from surgery beginning to anesthesia ending|1 day|||minutes|||Number
7937|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Placebo|Duration of surgery of patients receiving intranasal placebo Duration from surgery beginning to anesthesia ending|1 day|||minutes|||Number
7938|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Dexmedetomidine|Duration of anesthesia of patients receiving intranasal dexmedetomidine Duration from anesthesia intubation to anesthesia ending|1 day|||minutes|||Number
7940|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Dexmedetomidine|Duration of minutes From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal dexmedetomidine surgical data of Patients Receiving Intranasal dexmedetomidine.|1 day|||minutes|||Number
7941|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to anesthesia intubation of Patients Receiving Intranasal Placebo surgical data of patients receiving intranasal placebo|1 day|||minutes|||Number
7942|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Dexmedetomidine|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal dexmedetomidine surgical data of patients receiving intranasal dexmedetomidine|1 day|||minutes|||Number
7943|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to arrival at operating room of patients receiving intranasal placebo surgical data of patients receiving intranasal placebo|1 day|||minutes|||Number
7944|NCT02108171|Other Pre-specified|Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine|"American Society of Anesthesiologists (ASA) status of patients receiving intranasal placebo or dexmedetomidine.~ASA I: No organic, physiologic, biochemical or psychiatric disturbance ASA II: A patient with mild systemic disease that results in no functional limitation.~ASA III: A patient with severe systemic disease that results in functional impairment.~ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund condition in a patient who is not expected to survive with or without the operation.~ASA VI: Declared brain death patient whose organs are being harvested for transplantation."|1 day|||participant|||Number
7945|NCT02108171|Other Pre-specified|Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine|Baseline characteristics (sex)of patients receiving intranasal placebo or dexmedetomidine The sex of 81 adult patients receiving intranasal placebo or dexmedetomidine|1 day|||participants|||Number
7946|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The heights of 40 adult patients receiving intranasal placebo|1 day|||cm|||Number
7947|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The heights of 41 adult patients receiving intranasal placebo|1 day|||cm|||Number
7948|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The weights of 40 adult patients receiving intranasal dexmedetomidine|1 day|||kg|||Number
7949|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The weights of 41 adult patients receiving intranasal placebo|1 day|||kg|||Number
7950|NCT02108171|Secondary|Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine|Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.|1 day|||bpm||Standard Deviation|Mean
7951|NCT02108171|Secondary|Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine|"Modified Observer’s Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine.~Modified Observer’s Assessment of Alertness/Sedation Scale:~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus."|1 days|||units on a scale||Inter-Quartile Range|Median
7952|NCT02108171|Primary|Extubation Time After Intranasal Dexmedetomidine Premedication|The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration|1 days|||min||Standard Deviation|Mean
7953|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||Percent change||Standard Error|Least Squares Mean
7954|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||Percent change||Standard Error|Least Squares Mean
7955|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A1 ITT population.||percent change||Standard Error|Least Squares Mean
7956|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
7957|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
7958|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
8716|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>2 to <= 5 Years)|Piperaquine concentration at Day7 in African patients > 2 and <= 5years|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
7959|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).||percent change||Standard Error|Least Squares Mean
7960|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
7961|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
7962|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
7963|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|mITT population.||percentage of participants|||Number
7964|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis|"Calculated LDL-C goal was defined as:~<100 mg/dL (2.59 mmol/L) for heFH or non-FH participants who had a history of documented congestive heart disease (CHD), or~<120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases (ischemic stroke, peripheral artery disease, chronic kidney disease or diabetes) or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.~Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in imputation model."|Up to Week 24|ITT population.||percentage of participants|||Number
7965|NCT02107898|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
7966|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
7967|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
7968|NCT02107898|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
7969|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
7970|NCT02107898|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
7971|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
7972|NCT02107898|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
7973|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
7974|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
7975|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
7976|NCT02107898|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
7977|NCT02107599|Secondary|Change in Scan Interpretation Reliability After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.~NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative~Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection|||Fleiss Kappa||95% Confidence Interval|Number
7978|NCT02107599|Primary|Change in Reader Accuracy After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.~NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative~Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection|||Net Reclassification Index|||Number
7979|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|12 months after surgery||||||
7980|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|6 months after surgery||||||
7981|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|3 months after surgery||||||
7982|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|One month after surgery||||||
7983|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postoperative day 3|||units on a scale||Inter-Quartile Range|Median
7984|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|postoperative day 2|||units on a scale||Inter-Quartile Range|Median
7985|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postopertive day 1|||units on a scale||Inter-Quartile Range|Median
7986|NCT02107339|Secondary|Pain Scores Postoperative Day 3|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 72 hours after PACU admission|||units on a scale||Inter-Quartile Range|Median
7987|NCT02107339|Secondary|Pain Scores on Postoperative Day 2|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 48 hours after PACU admission|||units on a scale||Inter-Quartile Range|Median
7988|NCT02107339|Secondary|Pain Scores on Postoperative Day One|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores one day after PACU admission|||units on a scale||Inter-Quartile Range|Median
7989|NCT02107339|Secondary|Pain Scores 2 Hours After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 120 minutes after PACU admission|||units on a scale||Inter-Quartile Range|Median
7990|NCT02107339|Secondary|Pain Scores 1 Hour After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 60 minutes after PACU admission|||units on a scale||Inter-Quartile Range|Median
7991|NCT02107339|Secondary|Pain Scores Postanesthesia Care Unit (PACU) Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|First 5 minutes after PACU arrival|||units on a scale||Inter-Quartile Range|Median
7992|NCT02107339|Secondary|Hydromorphone Use Third 24 Hours||48-72 hours after surgery|||milligrams||Inter-Quartile Range|Median
7993|NCT02107339|Secondary|Hydromorphone Use Second 24 Hours||24-48 hours after surgery|||milligrams||Inter-Quartile Range|Median
7994|NCT02107339|Primary|Hydromorphone Use at 24 Hours||Use of hydromorphone at 24 hours|||milligrams||Inter-Quartile Range|Median
7995|NCT02107313|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events||Up to 15 days after the first dose of PBT2|Safety Population, as defined as all participants who received at least one dose of study drug||participants|||Number
8542|NCT02091414|Secondary|Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants||95% Confidence Interval|Number
7996|NCT02107313|Primary|Area Under the Concentration-Time Curve (AUC 0-t)||prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose|PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters.||h*ng/mL||Standard Deviation|Mean
7997|NCT02107274|Secondary|Spirometric Values: Forced Vital Capacity (FVC)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), Iong acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|||Litres||Standard Deviation|Mean
7998|NCT02107274|Secondary|Spirometry Value; Forced Expiratory Volume at 1 Second (FEV1)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), long acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|||Litres||Standard Deviation|Mean
7999|NCT02107274|Secondary|Health Status: St George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire is to be administered at visits 3, 6 and 8 inclusive. It should be administered in a quiet room where the participant can answer the questions without interruption, prior to any other protocol related procedures|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|||Units||Standard Deviation|Mean
8000|NCT02107274|Primary|24 Hour Sputum Volume|Each participant must be instructed and enabled to collect 24 hour sputum volumes over the 24 hours prior to visits 3, 6 and 8, inclusive. As this is the primary endpoint of the study, it is critical that 24 hour sputum volumes are measured and recorded accurately, observing the following protocol: The subject should be given a sterile jar to collect the sputum, which has been weighed previously for convenience. Each jar will be labelled with subject name, start and finish time/date The collection should commence on rising in the morning and complete 24 hours later. Ensure that the sputum sample has minimal saliva in the collection Instruct subject to collect all sputum produced spontaneously or after coughing over a single daytime 24 hour period. The sample should come from the lungs and should not be salivary. Encourage subject not to swallow sputum, but to collect. Each 24 hour collection period should be as similar as possible in terms of physiotherapy and exercise regimens|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|A total of 90 subjects were recruited. Among them, 78 subjects fulfilled the inclusion criteria and were randomized. Only 68 subjects completed the study and were subjected for analysis. We targeted to recruit 80 subjects and a dropout rate of 20% was anticipated as stated in the protocol.||gram||Standard Deviation|Mean
8001|NCT02107196|Secondary|Evaluation of Rebound Effects|"Comparison between average abdominal pain intensity (worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain) and average stool consistency score (the patients reported Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea) during the 4-week RW presented as change to baseline.~The analysis only included the patients randomised to ibodutant in the 12-week treatment period and re-randomised to placebo for the 4-week RW period. Baseline was considered as the average abdominal pain intensity/stool consistency in the 2-week Run-in period."|4 weeks|modified RW population: only patients randomised to ibodutant in the 12-week treatment period and re-randomized to placebo for the 4-week RW period (excluding patients from one site, where a potential serious breach of GCP was reported, and another site, where disqualification proceedings against the Investigator were confirmed by FDA).||units on a scale||Standard Deviation|Mean
8002|NCT02107196|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||percentage of responders|||Number
8003|NCT02107196|Secondary|Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly stool consistency responder if she meets the following criterion:~Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stool Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||percentage of responders|||Number
8016|NCT02106403|Primary|Participant-perceived Cooling Sensation at 5 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application.|At 5 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
8004|NCT02107196|Secondary|Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:~Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||percentage of responders|||Number
8005|NCT02107196|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:~Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;~Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stoll Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The primary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.||Percentage of Responders|||Number
8006|NCT02106728|Secondary|Change in Caregiver Functioning|EDSIS measures impact of ED.Subscales:Nutrition:0-32;Guilt:0-20;Dysregulated Behaviour:0-28;Social Isolation:0-16;Total: 0-96.Higher scores mean more negative appraisals of caregiving.Scores are summed.2)FQ measures criticism in families. Subscales:Critical Comments: 10-40;Emotional over-involvement: 10-40;Total:20-80.Higher scores mean higher perceived criticism.Scores are summed.3)SPS measures perceived social support. Attachment:4-16;Social Integration:4-16;Reassurance of Worth:4-16;Reliable Alliance Guidance:4-16;Opportunity for Nurturance:4-16;Total:24-96.Higher scores indicate higher social support.Scores are summed.4)Devaluation of consumers and consumer families measures perceived discrimination and stigma. Two subscales are:devaluation of consumers(8-32);devaluation of consumer’s families (7-28).Higher scores indicate higher levels of perceived discrimination and stigma. Subscales are summed separately.5)BDI, scored from 0-63:higher scores indicate higher levels of depression|Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment|||units on a scale||Standard Deviation|Mean
8007|NCT02106728|Primary|Change in Weight|Change in weight is measured to gauge if there has been a loss, gain, or maintenance.|Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)|||pounds||Standard Deviation|Mean
8008|NCT02106728|Primary|Dropout|3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)|3 months post enrollment|||participants|||Number
8009|NCT02106494|Secondary|Rate of No Emetic Episodes|To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
8010|NCT02106494|Secondary|Overall Complete Control Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
8011|NCT02106494|Secondary|Delayed Complete Control (CC) Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
8012|NCT02106494|Secondary|Overall Complete Response Rate|To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
8013|NCT02106494|Primary|Delayed Phase Complete Response (CR) Rate|Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.||percentage of participants|||Number
8014|NCT02106403|Secondary|Overall Sensory Liking of Study Products|Overall sensory liking of the study products was assessed immediately, 3min, 5 min and 15 min after products application. The assessment was done on a 9 point categorical scale where 1= Dislike it extremely, 2= Dislike it very much, 3= Dislike it moderately, 4= Dislike it slightly, 5= Neither like it nor dislike it, 6= Like it slightly, 7= Like it moderately, 8= Like it very much, 9= Like it extremely.|Immediatey, 3 min, 5 min and 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
8015|NCT02106403|Primary|Participant-perceived Cooling Sensation at 15 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application.|At 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
8096|NCT02104830|Secondary|Duration From ANC Nadir to ANC < 2.0 x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
8017|NCT02106403|Primary|Participant-perceived Cooling Sensation at 3 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application.|At 3 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
8018|NCT02106403|Primary|Participant-perceived Cooling Sensation Immediately Post Product Application|The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling).|Immediately after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population||Score on a scale||Standard Error|Least Squares Mean
8019|NCT02106156|Secondary|Percentage of Participants With the Most Frequent Concomitant Medications|Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.|At Baseline (Day 1)|Only main analysis set had evaluable data for this outcome measure.||percentage of participants|||Number
8020|NCT02106156|Secondary|Duration of Peginterferon Alfa-2a Therapy|Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.||weeks||Full Range|Median
8021|NCT02106156|Secondary|Percentage Cumulative Dose of Ribavirin Received|Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.||percentage of cumulated dose||Full Range|Median
8022|NCT02106156|Secondary|Percentage Cumulative Dose of Peginterferon Alfa-2a Received|Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.||percentage of cumulated dose||Full Range|Median
8023|NCT02106156|Primary|Percentage of Participants With Serious Adverse Drug Reactions (SADR)||Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.||percentage of participants|||Number
8024|NCT02106156|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.||percentage of participants|||Number
8025|NCT02106156|Primary|Percentage of Participants With End of Treatment (EOT) Response|EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.||percentage of participants|||Number
8026|NCT02106156|Primary|Percentage of Participants With Early Virologic Response (EVR)|EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.|At Week 12|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 12.||percentage of participants|||Number
8027|NCT02106156|Primary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.|At Week 4|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.||percentage of participants|||Number
8028|NCT02105987|Secondary|Number of Participants With Incidence of Genotypic and Phenotypic Resistance Meeting Confirmed Virologic Withdrawal Criteria Over 24 Weeks|Genotypic and phenotypic testing was conducted for participants who met the confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 c/mL any time after Day 1. The sample from the “suspected virologic withdrawal criterion” visit was tested for HIV-1 PRO and RT genotype and phenotype and HIV-1 integrase genotype and phenotype (i.e., the first of the two consecutive results >=400 c/mL). At the time of the data cut-off for this Week 24 analysis, no participants met the confirmed virologic withdrawal criteria over 24 weeks; therefore, the virologic analyses were not assessed.|Baseline and up to 24 weeks|Viral Genotypic and Phenotypic Populations: Comprised of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time confirmed virologic withdrawal criterion was met.|||||
8029|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Glucose at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
8717|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (> 5 Years)|Piperaquine concentration at Day7 in African patients > 5 years|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8030|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Soluble CD163 at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
8031|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Insulin at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
8032|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Homostat Model Assess of Insulin Resistance at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
8033|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, D-Dimer at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
8034|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, C-reactive Protein at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Percent||95% Confidence Interval|Geometric Mean
8035|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Percent||95% Confidence Interval|Geometric Mean
8036|NCT02105987|Secondary|Percent Change From Baseline in Bone Marker Analytes at Week 24|Outcome Measure Description: Bone biomarkers analytes include bone specific alkaline phosphatase, osteocalcin, procollagen 1 n-terminal propeptide, type I collagen c-telopeptides and were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, age, sex (male or female), body mass index (BMI) (<25 kilogram per meter [kg/m] or >=25 kg/m), smoking status (never smoked or former smoker or current smoker), Baseline vitamin D (no vitamin D use at Baseline or vitamin D use at Baseline), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Percent||95% Confidence Interval|Geometric Mean
8037|NCT02105987|Secondary|Change From Baseline in Urine Albumin/Creatinine Ratio at Week 24|Renal markers included urine albumin/creatinine ratioand summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Gram per mole (G/mol) creatinine||95% Confidence Interval|Least Squares Mean
8038|NCT02105987|Secondary|Change From Baseline in Urea at Week 24|Renal markers included urea and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
8039|NCT02105987|Secondary|Change From Baseline in GFR From Creatinine Adjusted Using MDRD Enzymatic Equation at Week 24|Renal markers included GFR from creatinine adjusted using modification of diet in renal disease (MDRD) enzymatic equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||mL/second/1.73 meter square||95% Confidence Interval|Least Squares Mean
8040|NCT02105987|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) From Creatinine Adjusted Using CKD-EPI Equation at Week 24|Renal markers included GFR from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI) equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||mL/second||95% Confidence Interval|Least Squares Mean
18968|NCT01797029|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through one week post-vaccination||||||
8041|NCT02105987|Secondary|Change From Baseline in Creatinine at Week 24|Renal markers included creatinine and summarized based on an observed case (OC) data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.||Micromoles per liter (umol/L)||95% Confidence Interval|Least Squares Mean
8042|NCT02105987|Secondary|Change From Baseline in Treatment Satisfaction at Week 4 and Week 24|The HIV treatment satisfaction questionnaire (TSQ) is a 10 item self-reported scale. Individual item scores range from 6 (very satisfied) to 0 (very dissatisfied). The treatment satisfaction total score (range 0-60) is the sum of all the 10 individual items. The general satisfaction/Clinical subscale (range 0-30) is the sum of the 5 clinical items and the lifestyle/ease subscale (range 0-30) is the sum of the remaining 5 lifestyle items. Last observation carried forward (LOCF) were used for the analysis. If a participant had a missing value at Week 24, his previous non-missing available value while on the same treatment was carried forward (ie the Week 4 or withdrawal value is used in the Week 24 summary for participants in the ABC/DTG3TC with missing Week 24 value). Data were analyzed using an ANCOVA model with factors including treatment, Baseline score and stratification factor. Treatment group difference (ABC/DTG/3TC-cART) estimate and 95% CI were presented.|Baseline, Week 4 and Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Units on a scale||Standard Error|Mean
8043|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Total Cholesterol/HDL Cholesterol Ratio) at Week 24|Change from Baseline for fasting lipid parameter total cholesterol/HDL cholesterol ratio. Adjusted mean is the estimated mean change from Baseline at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points.||Ratio||95% Confidence Interval|Least Squares Mean
8044|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24|Change from Baseline for each fasting lipid parameters included cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Adjusted mean is the estimated mean change from Baseline in each parameter at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
8045|NCT02105987|Secondary|Number of Participants With AEs Leading to Withdrawal Over 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia.|Baseline and up to 24 weeks|Safety Population||Participants|||Number
8046|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent hematology toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population||Participants|||Number
8047|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent chemistry toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population||Participants|||Number
8048|NCT02105987|Secondary|Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS estimates the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population: all participants who received at least one dose of study drug.||Participants|||Number
8049|NCT02105987|Secondary|Number of Participants in the Virologic Non-response Category From the Snapshot Analysis at Week 24|Virologic non-responders were defined as the participants with a viral load >=50 c/mL in the Week 24 analysis window. Virologic non-response includes participants who had HIV-1 RNA >=50 c/mL, who discontinued for lack of efficacy, who discontinued for other reasons while not suppressed, data in window but not <50 c/mL, and who changed ART regimen at Week 24. Difference is calculated as the proportion on ABC/DTG/3TC - proportion on current ART regimen.|Week 24|ITT-E Population||Participants|||Number
8050|NCT02105987|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24|Change from Baseline in CD4+ cell counts were assessed at Baseline, Weeks 4, 8, 16 and 24. No imputation for missing data or premature discontinuation was performed and the observed values were used. Baseline value is defined as the last pre-treatment value observed. Change from Baseline was calculated as the observed value minus the Baseline value. The Week 24 data were summarized.|Baseline and Week 24|ITT-E Population. Only participants with non-missing CD4 data at Week 24 are included.||Cells per cubic millimeter (cells/mm^3)||Inter-Quartile Range|Median
8051|NCT02105987|Primary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm|The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a “virology first” hierarchy. Virologic Success (e.g., <50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use HIV-1 RNA data from the late switch phase, even if such data is within the Week 24 analysis window). A virologic failure occurs when a participant changes to their ART regimen (e.g., addition of other ARTs to the study-specified regimens, or switches in components of the current ART regimen).|Week 24|Intent-to-Treat Exposed (ITT-E) Population: all participants randomized to ABC/DTG/3TC and receive at least one dose of study drug or randomized to remain on current ART regimen and continue in the study past Day 1.||Participants|||Number
8052|NCT02105974|Secondary|Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation|Time to first on-treatment exacerbation was analysed using a Cox proportional hazards model with terms for treatment, reversibility status and percent predicted FEV1 at screening. Exacerbation of COPD is defined by a worsening of symptoms requiring additional treatment. Moderate COPD exacerbation is worsening symptoms of COPD that require treatment with antibiotics and/or systemic corticosteroids. Severe COPD exacerbation is worsening symptoms of COPD that require treatment with in-patient hospitalization. The number of participants with On-Treatment moderate or severe COPD exacerbations are presented.|From the start of double blind study medication until visit 7 (week 12)/Early withdrawal|ITT Population||Participants|||Number
8053|NCT02105974|Secondary|Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 12 (Visit 7) each morning and prior prior to taking study medication (i.e., single-blind and double-blind study medication), supplemental medication (albuterol [salbutamol] if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) or oxitropium bromide (applicable sites in Japan) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Rescue-free 24-hour periods are defined as the 24-hour periods in which the rescue medication (albuterol [salbutamol]) was not used. The percentage of 24-hour periods are summarized for the entire treatment period (12 weeks). Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, reversibility status (stratum), baseline (week -1) and region.|BL (Week -1), Week 1 to Week 12|ITT Population, all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.||Percentage of rescue-free periods||Standard Error|Least Squares Mean
8054|NCT02105974|Primary|Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, reversibility status (stratum), BL, region, day, day by BL and day by treatment interactions.|Baseline to Day 84|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liter||Standard Error|Least Squares Mean
8055|NCT02105701|Secondary|Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|24 weeks after the end of all study treatment (up to 40 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
8056|NCT02105701|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.||Number of participants|||Number
8057|NCT02105701|Primary|Number of Participants Experiencing Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.||Number of participants|||Number
8718|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Asia (All Ages)|Piperaquine concentration at Day7 in Asian patients all ages|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8058|NCT02105701|Primary|Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|12 weeks after the end of all study treatment (up to 28 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
8059|NCT02105688|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24): Immediate Treatment Arm|Blood is drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 is defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method is used to construct 95% confidence intervals for the SVR24 rate. As pre-specified in the protocol, the Deferred Treatment Arm will not be included in the secondary efficacy analysis.|24 weeks after end of all therapy (Study Week 36)||05/2019||||
8060|NCT02105688|Primary|Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. For this study, the primary safety analysis compared the safety data in the Immediate Treatment Arm during the double-blinded treatment period to those of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period (up to 12 weeks)|APaT Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
8061|NCT02105688|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. For this study, the primary safety analysis compared the safety data in the Immediate Treatment Arm during the double-blinded treatment period to those of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period plus first 14 follow-up days (up to 14 weeks)|All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
8062|NCT02105688|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12): Immediate Treatment Arm|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. As pre-specified in the protocol, the Deferred Treatment Arm was not included in the primary efficacy analysis.|12 weeks after end of all therapy (Study Week 24)|Modified FAS (mFAS): All randomized participants in the Immediate Treatment Arm receiving ≥1 dose of study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. Deferred Treatment Arm was not included in primary efficacy analysis.||percentage of participants||95% Confidence Interval|Number
8063|NCT02105662|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)|FAS; all allocated participants who received at least 1 dose of study treatment.||percentage of participants|||Number
8064|NCT02105662|Primary|Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Treatment Period (up to 12 weeks)|APaT Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
8065|NCT02105662|Primary|Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Treatment Period plus first 14 follow-up days (up to 14 weeks)|All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.||percentage of participants|||Number
8066|NCT02105662|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.|12 weeks after end of all therapy (Study Week 24)|Full Analysis Set (FAS); all allocated participants who received at least 1 dose of study treatment.||percentage of participants|||Number
8067|NCT02105636|Other Pre-specified|Number of Participants With Death, Study Drug-Related Death, Serious Adverse Events (SAEs), and Study Drug-Related SAEs in All Treated Participants at Primary Endpoint|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Date of first dose of study drug to 30 days post last dose of study drug, approximately 18 months|All Treated Participants: All randomized participants who received at least one dose of study drug||participants|||Number
8068|NCT02105636|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Best overall response (BOR) was defined as the best response designation, recorded between the date of randomization and the date of progression, as assessed by the investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response assessments will contribute to the BOR assessment. For participants who continue treatment beyond progression, the BOR was determined based on response assessments up to the time of initial RECIST 1.1 progression.|Randomization to disease progression or study drug is discontinued, whichever occurs first; Approximately 5 years||09/2019||||
8069|NCT02105636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria), or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants without any on study tumor assessments and did not die were censored on their date of randomization. Participants who received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.|Randomization to disease progression or death, whichever occurs first; Approximately 5 years||09/2019||||
8070|NCT02105636|Primary|Overall Survival (OS) Rate in All Randomized Participants at Primary Endpoint|The overall survival rate is the probability that a participant will be alive at 3, 6, 9, and 12 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 3, 6, 9, and 12 months|All randomized participants||percent probability of OS||95% Confidence Interval|Number
8071|NCT02105636|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) occurred at 218 deaths.|From date of randomization to date of death, approximately 18 months|All randomized participants.||months||95% Confidence Interval|Median
8072|NCT02105467|Secondary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks After the End of Treatment (SVR24)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR24 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 24 weeks after the end of all study therapy.|Week 36 (24 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.||Percentage of participants||95% Confidence Interval|Number
8073|NCT02105467|Other Pre-specified|Percentage of Participants Achieving Sustained Virologic Response at 4 Weeks After the End of Treatment (SVR4)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR4 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 4 weeks after the end of all study therapy.|Week 16 (4 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.||Percentage of participants||95% Confidence Interval|Number
8074|NCT02105467|Primary|Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 12 (end of Blinded Treatment)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.||Percentage of participants|||Number
8097|NCT02104830|Secondary|Neutropenia Duration, Any Grade||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
8075|NCT02105467|Primary|Percentage of Participants Experiencing at Least One Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 14 (14 days after the Blinded Treatment was completed)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.||Percentage of participants|||Number
8076|NCT02105467|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA <Lower Limit of Quantification (<15 IU/mL) 12 weeks after the end of all study therapy.|Week 24 (12 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.||Percentage of participants||95% Confidence Interval|Number
8077|NCT02105454|Secondary|Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy|SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
8078|NCT02105454|Primary|Percentage of Participants Discontinuing Study Drug Due to an Adverse Event|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 12 weeks|All participants as treated population defined as all participants who received at least one dose of study medication.||Percentage of participants|||Number
8079|NCT02105454|Primary|Percentage of Participants Experiencing Adverse Events|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)|All participants as treated population defined as all participants who received at least one dose of study medication.||Percentage of participants|||Number
8080|NCT02105454|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.||Percentage of participants||95% Confidence Interval|Number
8081|NCT02105285|Secondary|Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 8 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
8082|NCT02105285|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
8083|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration|||mmHg||Standard Error|Mean
8098|NCT02104830|Secondary|Low Level (Nadir) ANC x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||cells x 10^9/L||Standard Deviation|Mean
8084|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration|||mmHg||Standard Error|Mean
8085|NCT02105285|Secondary|Intraocular Pressure at Week 8 Predose|"Comparison of each group in intraocular pressure at Week 8 Predose. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 Predose|||mmHg||Standard Error|Mean
8086|NCT02105285|Primary|Decrease From Baseline in Intraocular Pressure at Week 8 Predose|"Comparison of each group in change from baseline in intraocular pressure. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group."|Baseline, Week 8 Predose|||mmHg||95% Confidence Interval|Mean
8087|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
8088|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration|||mmHg||95% Confidence Interval|Mean
8089|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration|||mmHg||Standard Error|Mean
8090|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration|||mmHg||Standard Error|Mean
8091|NCT02105272|Secondary|Intraocular Pressure at Week 8 Predose|Comparison of each group in intraocular pressure at Week 8 Predose. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.|Week 8 Predose|||mmHg||Standard Error|Mean
8092|NCT02105272|Primary|Decrease From Baseline in Intraocular Pressure||Baseline, week 8 predose|||mmHg||95% Confidence Interval|Mean
8093|NCT02104895|Secondary|Excellent Cosmesis|Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects|5 years|||percentage of participants|||Number
8094|NCT02104895|Secondary|Acute Skin Toxicity|"Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced Acute skin toxicity ≥ grade 2"|5 years|||percentage of participants|||Number
8095|NCT02104895|Primary|Ipsilateral Breast Tumor Recurrence|"We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced Ipsilateral Breast Tumor Recurrence"|5-year|||percentage of participants|||Number
8100|NCT02104830|Secondary|The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);||2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
8101|NCT02104830|Primary|Duration of Neutropenia CTCAE Grade 4|The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).|3 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.||days||Standard Deviation|Mean
8102|NCT02104219|Other Pre-specified|Rickets Severity Sale - RSS|The RSS is a 10-point scale, developed for nutritional rickets, that evaluates the degree of metaphyseal cupping and fraying and the proportion of growth plate affected (10 points = severe cupping/fraying, 0 points = absence of cupping/fraying).|Any available data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment value during the period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.||units on a scale||Inter-Quartile Range|Median
8103|NCT02104219|Secondary|Change in Weight Z-score From Baseline to Last Assessment|Weight measurements were assigned a Z-score which was calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while Post baselines are time points after Baseline during the defined age period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.||Z-score||Inter-Quartile Range|Median
8104|NCT02104219|Secondary|Change in Height Z-score From Baseline to Last Assessment|Height measurements were assigned to Z-scores which were calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while post baselines are time points after Baseline during the defined age period.|||Z-score||Inter-Quartile Range|Median
8105|NCT02104219|Primary|Radiographic Global Impression of Change - RGI-C|The RGI-C scale is a 7-point ordinal scale that is used to evaluate musculoskeletal characteristics of HPP (eg, metaphyseal fraying, demineralization of distal metaphyses). The scores range from -3 (severe worsening) to +3 (complete or near-complete healing).|Between Baseline (earliest available, complete, and readable x-ray set) and all available, readable post-Baseline x-ray sets during the period of patients' aged 5 to 15 years, inclusive.|Patients diagnosed with juvenile-onset HPP.||units on a scale||Inter-Quartile Range|Median
8106|NCT02103439|Secondary|Biochemical Response|Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy|12 weeks|||percentage of patients|||Number
8107|NCT02103439|Primary|Early Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving early virologic response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks|||percentage of patients|||Number
8108|NCT02103439|Secondary|Viral Breakthrough|Proportion of patients in each groups with level of Hepatitis C Virus ribonucleic acid > 15 IU/ml after Hepatitis C Virus ribonucleic acid was not present or Hepatitis C Virus ribonucleic acid was increased by more than 1log10 from baseline at 4 or 12 weeks of treatment|screening data and at 4 or 12 weeks of treatment.|||percentage of patients|||Number
8109|NCT02103439|Secondary|Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving rapid virological response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks|||percentage of patients|||Number
8110|NCT02103439|Secondary|Rapid Virological Response|Proportion of randomized patients achieving rapid virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks|||percentage of patients|||Number
8111|NCT02103439|Primary|Early Virological Response|Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks|||percentage of patients|||Number
8112|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)|The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. “Overall Vision” was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
8113|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Handling and Overall Vision)|The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
8114|NCT02103309|Secondary|Mean Investigator-Rated Lens Fit|Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
8543|NCT02091414|Secondary|Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
8115|NCT02103309|Primary|Mean Investigator-Rated Lens Centration|Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.||units on a scale||Standard Deviation|Mean
8116|NCT02103062|Other Pre-specified|Kaplan Meier Estimate of PFS by Investigator Assessment|PFS was measured as time from the date of first dose to the date of disease progression according to RECIST 1.1 or death from any cause, whichever was earlier.|Up to 241 days|Intent-to-treat Population defined as participants who received treatment and met all eligibility criteria||weeks||95% Confidence Interval|Median
8117|NCT02103062|Secondary|Number of Participants With Adverse Events|A treatment emergent adverse events (TEAE) was defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and Severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Lifethreatening; Grade 5-Fatal;|Time of the first dose of study treatment to 28 days after the last dose of study drug; maximum treatment duration was 24 weeks|Safety population includes all participants who received at least one dose of study treatment||participants|||Number
8118|NCT02103062|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion was met to the date of disease progression based on investigational assessment following RECIST 1.1.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. Duration of response was not analyzed as there were no responders observed in the study.|||||
8119|NCT02103062|Secondary|Percentage of Participants With Stable Disease for ≥ 8 Weeks, or Complete or Partial Response According to RECIST Version 1.1; Disease Control Rate (DCR)|DCR was defined as the combined incidence of stable disease confirmed CR or PR and stable disease (SD) measured at the Week 8 assessment or later.|At week 8 and later; up to day 241|ITT Population defined as participants who received treatment and met all eligibility criteria||Percentage of participants||95% Confidence Interval|Number
8120|NCT02103062|Secondary|Overall Response Rate (ORR)|"ORR was defined as the combined incidence of Complete Response (CR) and Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met based on RECIST 1.1. Tumor responses were assessed every 2 cycles using RECIST 1.1 and defined as:~Complete response-disappearance of all target lesions~Partial response- At least a 30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)~Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir."|Up to 241 days|ITT population defined as participants who received treatment and met all eligibility criteria.||percentage of participants||95% Confidence Interval|Number
8121|NCT02103062|Secondary|Overall Survival|Overall Survival was the time from the first dose of study drug to patient death from any cause.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. The study was stopped early and the analysis of overall survival was not performed.|||||
8122|NCT02103062|Primary|Progression Free Survival (PFS) Rate as Measured at Week 8|PFS rate was measured by Investigator Assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the start of study treatment to disease progression or death from any cause, whichever occurred first.|At week 8 assessment period; up to 56 days|Per the Simon 2-stage design, only 30 participants from Stage 1 (the first 15 participants in the Intent to Treat (ITT) population from each cohort) were included. The ITT population was defined as those who received treatment and met all eligibility criteria; four ineligible participants were excluded based on the protocol deviations/violations||percentage of participants||95% Confidence Interval|Number
8123|NCT02102932|Secondary|AUC(0-tz) of Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
8124|NCT02102932|Secondary|AUC(0-tz) of Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
8125|NCT02102932|Primary|Cmax for Metformin|Maximum measured concentration of the metformin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8126|NCT02102932|Primary|Cmax for Empagliflozin|Maximum measured concentration of the empagliflozin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||nmol/L||Geometric Coefficient of Variation|Geometric Mean
8127|NCT02102932|Primary|AUC(0-∞) for Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
8128|NCT02102932|Primary|AUC(0-∞) for Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
8129|NCT02102399|Secondary|Post-treatment Questionnaire (Compliance With Intervention)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their degree of compliance on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). It was considered compliance the answers moderate and a lot in comparison of not at all/somewhat, considered as no compliance. The results were presented in frequency/percentage of subjects in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of subjects|||Number
8130|NCT02102399|Secondary|Post-treatment Questionnaire (Easier to Talk)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of subjects|||Number
8131|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Clearer)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of subjects|||Number
8132|NCT02102399|Primary|Change in GNE|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||Decibel (dB)||Standard Deviation|Mean
8133|NCT02102399|Primary|Change in Noise|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||Decibel (dB)||Standard Deviation|Mean
8134|NCT02102399|Primary|Change in Shimmer|Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%|Baseline, 6 weeks|||percentage of shimmer||Standard Deviation|Mean
8135|NCT02102399|Primary|Change in Jitter|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||percentage of jitter||Standard Deviation|Mean
8136|NCT02102399|Primary|Change in Fundamental Frequency|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||Hertz (Hz)||Standard Deviation|Mean
8137|NCT02102399|Primary|Change in Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)||units on a scale||Standard Deviation|Mean
8138|NCT02102399|Primary|Acoustic Analysis (GNE) 2|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
8139|NCT02102399|Primary|Acoustic Analysis (Noise) 2|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
8140|NCT02102399|Primary|Acoustic Analysis (Shimmer) 2|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.~Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of shimmer||Standard Deviation|Mean
8141|NCT02102399|Primary|Acoustic Analysis (Jitter) 2|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of jitter||Standard Deviation|Mean
8142|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency) 2|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Hertz (Hz)||Standard Deviation|Mean
8143|NCT02102399|Primary|Voice Handicap Index (VHI-10) 2|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||units on a scale||Standard Deviation|Mean
8144|NCT02102399|Primary|Acoustic Analysis (GNE)|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
8145|NCT02102399|Primary|Acoustic Analysis (Noise)|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Decibel (dB)||Standard Deviation|Mean
8146|NCT02102399|Primary|Acoustic Analysis (Shimmer)|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.~Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of shimmer||Standard Deviation|Mean
8147|NCT02102399|Primary|Acoustic Analysis (Jitter)|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||percentage of jitter||Standard Deviation|Mean
8148|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Symptoms Improvement)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis||percentage of participants|||Number
8149|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency)|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||Hertz (Hz)||Standard Deviation|Mean
8150|NCT02102399|Primary|Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)||units on a scale||Standard Deviation|Mean
8151|NCT02101359|Primary|The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.||Day 0|Modified ITT (mITT) Set: All randomised patients for whom there was evidence they used the study medication, and who satisfied the non-inclusion criterion concerning unauthorized previous and concomitant medications. Patients were assigned to the treatment group as treated.||percentage of responders|||Number
8152|NCT02101294|Secondary|Measurement of Increase in Wrist Swelling Following FingerRelief Typing|Before and after the typing session, the subject's wrist was measured. The mean change score of all participants is reported here.|Pre and Post|||centimeters||Standard Deviation|Mean
8153|NCT02101294|Primary|Length of Time Typing FingerRelief Prior to Experiencing Symptoms of CTS|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure, averaged across the two typing sessions that were FingerRelief.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside|||minutes||Standard Deviation|Mean
8544|NCT02091414|Secondary|Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
8154|NCT02101294|Secondary|Measurement of Wrist Swelling Following Cessation of QWERTY Typing|Before and after typing, the subject's wrists were measured with a tape measure. The change score is reported here.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside|||centimeters||Standard Deviation|Mean
8155|NCT02101294|Primary|Length of Time Typing QWERTY Prior to Experiencing Symptoms of CTS (Carpal Tunnel Syndrome)|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure. Length of time typing at each QWERTY session was averaged across the two sessions to determine Length of time typing QWERTY.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside|||minutes||Standard Deviation|Mean
8156|NCT02101190|Primary|Area Under the Curve (AUC0-t)|BIA 9-1067 AUC0-t following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose|||ng.hr/mL||Standard Deviation|Mean
8157|NCT02101190|Primary|Tmax - Time to Reach Cmax|BIA 9-1067 Tmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose|||hours||Full Range|Median
8158|NCT02101190|Primary|Cmax - Maximum Plasma Concentration of BIA 9-1067|BIA 9-1067 Cmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
8159|NCT02101112|Secondary|Relative Bioavailability (Frel) of Apixaban|Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet).|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ratio||Geometric Coefficient of Variation|Geometric Mean
8160|NCT02101112|Secondary|Terminal Plasma Half-life (T-HALF) of Apixaban|Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body.|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||hours||Standard Deviation|Mean
8161|NCT02101112|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Time of maximum observed plasma concentration (Tmax) measured in hours (h)|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||hours||Full Range|Median
8162|NCT02101112|Secondary|Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion|Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to May 2014; approximately 6 weeks|All randomized and treated participants||participants|||Number
8163|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration [AUC (0-T)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ng*h/mL||90% Confidence Interval|Geometric Mean
8164|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) [AUC (INF)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ng*h/mL||90% Confidence Interval|Geometric Mean
8165|NCT02101112|Primary|Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban||ng/mL||90% Confidence Interval|Geometric Mean
8166|NCT02101008|Secondary|Progression Free Survival||Every 56 days - for up to two years|||days||Standard Deviation|Mean
8167|NCT02101008|Primary|Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Response to treatment will be measured by RECIST evaluation at disease assessment time-points from date of randomization until the date of first documented progression or death from any cause whichever came first (up to five years).|||participants|||Number
8168|NCT02100839|Secondary|Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change|Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.|Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57|||Max % Change Versus Baseline||Standard Deviation|Mean
8193|NCT02099838|Other Pre-specified|Change of AST From Baseline at Week 12|Measuring venous level of AST at the start of the trail and at week 12 in all subjects, then analyzing the change in AST from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||U/L||Standard Deviation|Mean
8169|NCT02100839|Primary|Number of Participants Who Incurred Moderate Treatment Emergent Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57|||Number of Participants|||Number
8170|NCT02100839|Primary|Number of Participants Who Incurred Mild Treatment Emergent Adverse Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57|||Number of Participants|||Number
8171|NCT02100839|Primary|Number of Participants Who Incurred at Least One Treatment Emergent Event|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57|||participants|||Number
8172|NCT02100826|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
8173|NCT02100826|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data||Hours||Standard Deviation|Median
8174|NCT02100826|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||hour*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
8175|NCT02100644|Secondary|Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation of the Investigational Product and/or Withdrawal From the Study, Drug-related AEs, Deaths and Serious Adverse Events (SAEs) Throughout the Study|An AE is defined as untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgement and all events of possible drug-induced liver injury.|From the start of study treatment until follow-up (up to 50 weeks)|Safety Population: comprised of participants who received at least one dose of the investigational product during the LTG Escalation Phase.||Participants|||Number
8176|NCT02100644|Secondary|Percentage of Participants Who Completed or Discontinued From the Study|Following cases were considered for participants to have completed a part of or whole of the study. For whole period completion: participants who completed the last LTG and VPA Maintenance Phase visit (M5) in the LTG and VPA Maintenance Phase and follow-up examination. For LTG Escalation Phase completion: participants who reached 200 mg/d of LTG (or 100-200 mg/d of LTG if there were safety concerns) within 8-18 weeks of the phase. For VPA Reduction Phase completion: participants who completed the last fixed dose of VPA Reduction Phase visit (0 mg/d) (FR4) of the phase. For LTG and VPA Maintenance Phase completion: participants who completed M5 of the phase. Participants who met any of the withdrawal criteria after the start of investigational product were considered to have discontinued the study. Percentage of participants who completed or discontinued/withdrawn from the study is presented.|Up to 50 weeks|Enrolled Population: comprised of all participants who had a Baseline (Week 0) visit.||Percentage of participants|||Number
8177|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) in Participants Aged 15-17 Years|QOLIE-AD-48 is a questionnaire analyzed according to the scoring manual at Baseline, at the end of the LTG/VPA Maintenance Phase and withdrawals for participants aged 15-17 years (n=6). Particpants who has started by QOLIE-AD-48 were using the same questionnaire even after 18 years old. Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-AD-48 has 8 subscale items (epilepsy impact, memory/concentration, physical fuctioning, stigma, social support, school behavior, attitudes towards epilepsy and health perceptions). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-AD-48 is world widely used for the QOL assessment of non-adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).||Units on a scale||Standard Deviation|Mean
8194|NCT02099838|Other Pre-specified|Change of ALT From Baseline at Week 12|Measuring venous level of ALT at the start of the trail and at week 12 in all subjects, then analyzing the change in ALT from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||U/L||Standard Error|Mean
8178|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy-31-P (QOLIE-31-P) in Participants Aged 18 Years and Older|QOLIE-31-P is a questionnaire analyzed according to the scoring manual at Baseline, at the end of LTG/VPA Maintenance Phase and withdrawals for the participants aged 18 years and older (n=26, excluding 1 participant withdrawn due to protocol violation). Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-31-P has 7 subscale items (energy, mood, daily activities, cognition, medication effect, seizure worry and overall QOL). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-31-P is world widely used for the QOL assessment of adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).||Scores on a scale||Standard Deviation|Mean
8179|NCT02100644|Secondary|Number of Days in Total That Epileptic Seizures Occurred up to the LTG and VPA Maintenance Phase|The participants with no seizure, had no record in seizure dairy. Only those participants with more than one seizure were assessed for this Outcome Measure.|Baseline and up to 46 weeks|FAS Population||Days|||Number
8180|NCT02100644|Primary|Percent Change in the VPA Dose|Percent change in VPA dose is calculated as (pre-dose - post-dose) / pre-dose x 100. Pre-dose is the VPA dose at the Baseline visit and post-dose is the last VPA dose during the LTG and VPA Maintenance Phase.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|FAS Population||Percentage of reduction||Standard Deviation|Mean
8181|NCT02100644|Primary|Percentage of Participants Who Achieved Reduction in Daily VPA Dose|The VPA dose reduction from Baseline is defined as post VPA dose minus the Baseline VPA dose < 0. Baseline VPA dose is the dose at the Baseline visit (Week 0) and the post VPA dose is the last VPA dose during the LTG and VPA Maintenance Phase. Percentage of participants with dose reduction during the LTG and VPA Maintenance Phase is presented.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|Full analysis set (FAS): comprised of all participants in the Safety Population who provided at least one efficacy data after the first dose of the investigational product during the LTG Escalation Phase.||Percentage of participants||95% Confidence Interval|Number
8182|NCT02100579|Secondary|Length of Hospitalization|The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.|0 to 192 hours|||hours||95% Confidence Interval|Mean
8183|NCT02100579|Secondary|Visual Analog Scale Pain Score|Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.|Pain burden at 36hr|||score times hours||Inter-Quartile Range|Median
8184|NCT02100579|Primary|Opioid Consumption (mg morEq)|Opioid consumption (morphine equivalents)|36 hours|||Morphine Equivalents||Inter-Quartile Range|Median
8185|NCT02100475|Secondary|Number of Treatment-emergent Confirmed Hypoglycaemic Episodes|Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL).|Week 0 - 26|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (31 subjects). Confirmed hypoglycaemic episodes were reported by 2 subjects in IDegLira arm and 2 subjects in IDegLira + IAsp arm.||Number of episodes|||Number
8186|NCT02100475|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|FAS included all randomised subject (31 subjects). Missing data were imputed using the LOCF method.||Kilograms||Standard Deviation|Mean
8187|NCT02100475|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|Full analysis set (FAS) included all randomised subjects (31 subjects). Missing data were imputed using the last observation carried forward (LOCF) method.||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
8188|NCT02100410|Secondary|Handling on Removal|Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.||units on a scale||Standard Deviation|Mean
8189|NCT02100410|Secondary|Lens Awareness|Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.||units on a scale||Standard Deviation|Mean
8190|NCT02100410|Primary|Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear|Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.||percentage of lenses|||Number
8191|NCT02099838|Other Pre-specified|Change of DBil From Baseline at Week 12|Measuring venous level of DBil(direct bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in DBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||mmol/L||Standard Deviation|Mean
8192|NCT02099838|Other Pre-specified|Change of TBil From Baseline at Week 12|Measuring venous level of TBil(total bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in TBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.||mmol/L||Standard Deviation|Mean
8270|NCT02097108|Secondary|Total Cholesterol Baseline and After 24 Weeks||baseline to week 24|||mg/dl||Standard Deviation|Mean
8195|NCT02099838|Secondary|Change of LDL From Baseline at Week 12|Measuring venous level of LDL(Low-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of LDL to analyze the change in LDL from baseline at week 12 and compare that between experiment group and control group, since the LDL wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mmol/L)||Standard Deviation|Mean
8196|NCT02099838|Secondary|Change of HDL From Baseline at Week 12|Measuring venous level of HDL(High-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then analyzing the change in HDL from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
8197|NCT02099838|Secondary|Change of TG From Baseline at Week 12|Measuring venous level of TG(Triglyceride) at the start of the trail and at week 12 in all subjects, then analyzing the change in TG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
8198|NCT02099838|Secondary|Change of TC From Baseline at Week 12|Measuring venous level of TC(Total Cholesterol) at the start of the trail and at week 12 in all subjects, then analyzing the change in TC from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
8199|NCT02099838|Secondary|Change of 2-hour Postprandial Insulin From Baseline at Week 12|Measuring venous level of 2-hour postprandial insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of 2-hour postprandial insulin to analyze the change in 2-hour postprandial insulin from baseline at week 12 and compare that between experiment group and control group, since the 2-hour postprandial insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mU/L)||Standard Deviation|Mean
8200|NCT02099838|Secondary|Change of Fasting Insulin From Baseline at Week 12|Measuring venous level of fasting insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of fasting insulin to analyze the change in fasting insulin from baseline at week 12 and compare that between experiment group and control group, since the fasting insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mU/L)||Standard Deviation|Mean
8201|NCT02099838|Secondary|Change of 2hPPG From Baseline at Week 12|Measuring venous level of 2hPPG(2-hour postprandial glucose) at the start of the trail and at week 12 in all subjects, then analyzing the change in 2hPPG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||mmol/L||Standard Deviation|Mean
8202|NCT02099838|Secondary|Change of FPG From Baseline at Week 12|Measuring venous level of FPG(fasting plasma glucose) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of FPG to analyze the change in FPG from baseline at week 12 and compare that between experiment group and control group, since the FPG wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.||ln(mmol/L)||Standard Deviation|Mean
8203|NCT02099838|Primary|Change of HbA1c From Baseline at Week 12|Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then using the natural logarithm of HbA1c to analyze the change in HbA1c from baseline at week 12 and compare that between experiment group and control group, since the HbA1c wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. Intention to treat analysis and last observational carried forward(LOCF) imputation method.||ln(percent)||Standard Deviation|Mean
8204|NCT02099708|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
8205|NCT02099708|Secondary|Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|"Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.~Participants could be counted in more than 1 treatment category."|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
8206|NCT02099708|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
8207|NCT02099708|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
8208|NCT02099708|Secondary|Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
8209|NCT02099708|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcer.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||Participants|||Number
8210|NCT02099708|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.||participants|||Number
8211|NCT02099708|Primary|Frequency of Adverse Drug Reactions|Frequency was defined as the number of participants for each adverse event Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set (SAS) - All participants who received at least 1 dose of open-label study drug.||participants|||Number
8212|NCT02099682|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
8213|NCT02099682|Secondary|Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
8214|NCT02099682|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
8215|NCT02099682|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
8216|NCT02099682|Secondary|Presence of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
8217|NCT02099682|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcers.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
8218|NCT02099682|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of endoscopic examinations.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.||participants|||Number
8219|NCT02099682|Primary|Frequency of Adverse Drug Reactions|Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set - All participants who received at least 1 dose of lansoprazole.||participants|||Number
8220|NCT02099461|Primary|Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells|Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.|Baseline and Day 28|Pharmacodynamic analysis set with non-missing data||log ratio||Standard Deviation|Mean
8221|NCT02099344|Secondary|Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft|Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.|12 months||||||
8222|NCT02099344|Primary|Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft|The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.|12 months|Data not collected due to early study termination|||||
8223|NCT02099084|Other Pre-specified|Urine Volume at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. Urine was collected twice: from the start of the ingestion of the meal to 2 hours, and 2-8 hours. The total volume of urine collected was the sum of these two collections.|Start of the ingestion of the radiolabeled meal until 8 hours after the meal|||mL||Standard Deviation|Mean
8224|NCT02099084|Other Pre-specified|Stool Weight at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. After 8 hours a stool collection was taken.|approximately 8 hours after ingestion of radiolabeled meal|||g||Standard Deviation|Mean
8225|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal|||ratio||Standard Deviation|Mean
8226|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal|||mg||Standard Deviation|Mean
8227|NCT02099084|Primary|Overall Gut Transit|Given the variable extent of the residual length of the small intestine and colon, the proportion emptied from the body at 6 hours was assessed as an overall estimate of the whole gut transit. The 6-hour values for intra-abdominal counts were then compared with the 100% reference values of counts (at time zero, which is immediately after ingestion of the radiolabeled meal) to determine the percentage of isotope retained in the abdomen. 100% minus the percentage of retained isotope reflected the amount emptied from the GI tract.|baseline, approximately 6 hours after ingestion of radiolabeled meal|||Percentage of isotope emptied||Standard Deviation|Mean
8228|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal|||mg||Standard Error|Mean
8229|NCT02099084|Primary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested|||minutes||Standard Deviation|Mean
8230|NCT02099006|Secondary|Reduction in Tampon Test Pain|"Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of 0 was defined as no pain, and a score of 10 was defined as worst imaginable pain."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.||units on a scale||Standard Deviation|Mean
8231|NCT02099006|Primary|Reduction in Daily Genital Pain.|"Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of 0 was defined as no pain and a score of 10 was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.||units on a scale||Standard Deviation|Mean
8232|NCT02098746|Primary|Frequency of Serious Adverse Drug Reactions|Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).||participants|||Number
8233|NCT02098746|Secondary|Change From Baseline in Fasting Insulin Level|Tabulation of fasting insulin level and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.||μU/dL||Standard Deviation|Mean
8234|NCT02098746|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulation of fasting blood glucose level and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.||mg/dL||Standard Deviation|Mean
8235|NCT02098746|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of HbA1c values and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.||percent||Standard Deviation|Mean
8236|NCT02098746|Primary|Frequency of Adverse Drug Reactions|Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).||participants|||Number
8237|NCT02098733|Secondary|Fasting Insulin Level|Tabulated fasting insulin level at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||μU/dL||Standard Deviation|Mean
8238|NCT02098733|Secondary|Change From Baseline in Fasting Insulin Level|Tabulated the changes from baseline at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||μU/dL||Standard Deviation|Mean
8239|NCT02098733|Secondary|Fasting Blood Glucose Level|Tabulated fasting blood glucose level from baseline at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||mg/dL||Standard Deviation|Mean
8240|NCT02098733|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||mg/dL||Standard Deviation|Mean
8241|NCT02098733|Secondary|Glycosylated Hemoglobin (HbA1c)|Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
8242|NCT02098733|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
8243|NCT02098733|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|For 12 months|All enrolled participants with available data.||participants|||Number
8244|NCT02098395|Secondary|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes|Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.|Weeks 0-26|Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.||episodes|||Number
8245|NCT02098395|Secondary|Change From Baseline in Body Weight|Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.||kg||Standard Deviation|Mean
8246|NCT02098395|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
8247|NCT02098304|Secondary|User Experience|Completion of User Questionnaires after imaging with the Calcivis System|0 day|User Questionnaires comprised nine questions and users were asked to tick the most appropriate response i.e. extremely easy, easy etc. No numerical values were assigned to the responses.||User questionnaires|||Number
8248|NCT02098304|Secondary|Patient Experience|Completion of Patient Questionnaires after imaging with the Calcivis System|Day 0|Patient Questionnaires comprised five questions and the patient was asked to tick the most appropriate response i.e very good, good etc. No numerical values were assigned to the responses||Patient Questionnaires|Participants||Number
8249|NCT02098304|Primary|Measure Safety of the Calcivis Caries Imaging System|Collection of all adverse events recorded and reported throughout the duration of the study|Day 0 and Day 7|Adverse events||adverse events|||Number
8250|NCT02098304|Primary|Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System|% agreement calculated as no. of teeth where ICDAS assessment & Calcivis System assessment is in agreement/total number of teeth assessed multiplied by 100. Agreement defined as a sound tooth without luminescence & an unsound tooth with luminescence.|Day 0|All 42 patients recruited are included in the Safety Population, which included any subjects on whom the Calcivis System was used. 31 patients are included in the Agreement Population which included all subjects with at least one tooth with an eligible image. From the 31 patients, 65 teeth were analysed; in some patients multiple teeth were imaged.||percentage agreement|Participants|95% Confidence Interval|Number
8251|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
8252|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score joint space narrowing of 0-4 (9 gradations) is assigned to 13 joints in each hand and 6 joints in each foot. The maximum joint space narrowing score is 38 x 4.0 = 152 which is normalized to a score of 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
8253|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
8254|NCT02097745|Secondary|Change From Baseline in the Total Genant-modified Sharp Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Units on a scale||Standard Deviation|Mean
8255|NCT02097745|Secondary|Percentage of Participants With no Radiographic Progression From Baseline to Year 5|Radiographic progression was defined as a change of ≤ 0 in the total Genant-modified Sharp score. The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
8256|NCT02097745|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT-F is a 13-item participant self-reporting questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
8257|NCT02097745|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
8258|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
8362|NCT02094885|Secondary|Hemostasis at the TBS at 3 and 6 Minutes Following the Completion of Treatment Application||Intra-operative, 3 and 6 minutes following randomization|||percentage of participants||95% Confidence Interval|Number
8259|NCT02097745|Secondary|Change From Baseline in the American College of Rheumatology n (ACRn) Response|The ACRn response was defined as each participant’s least favorable percentage change from Baseline in 3 measures, tender joint count, swollen joint count (28 assessed joints), and improvement score achieved in at least 3 of the 5 remaining ACR parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity, right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain, right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). A higher change percentage indicates greater improvement from Baseline. The ACRn response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage change||Standard Deviation|Mean
8260|NCT02097745|Secondary|Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage of participants|||Number
8261|NCT02097745|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity was defined as a DAS28 score ≤ 3.2. DAS28 remission was defined as a DAS28 score < 2.6. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage of participants|||Number
8262|NCT02097745|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28)|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score represents higher disease activity. A negative change score indicates improvement. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Units on a scale||Standard Deviation|Mean
8263|NCT02097745|Primary|Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.||Percentage of participants|||Number
8264|NCT02097719|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication with data at the noted time point||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
8265|NCT02097537|Secondary|The Summary Statistic of PC20, the Concentration of Methacholine Causing 20% Fall in FEV1||Visit 1 (Day 1)|||mg/mL||Standard Deviation|Mean
8266|NCT02097537|Secondary|The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation||Visit 1 (Day 1)|||percentage of the subjects|||Number
8267|NCT02097537|Primary|The Rate of Subjects Whose PC20, the Concentration of Methacholine Causing 20% Fall in FEV1, is Less Than 8 mg/mL||Visit 1 (Day 1)|||percentage of the subjects|||Number
8268|NCT02097108|Secondary|High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks||baseline to week 24|||mg/dl||Standard Deviation|Mean
8269|NCT02097108|Secondary|Triglycerides Baseline and After 24 Weeks||baseline to week 24|||mg/dl||Standard Deviation|Mean
8271|NCT02097108|Primary|Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction|A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.|baseline to week 12|all patients||percentage of participants||95% Confidence Interval|Number
8272|NCT02097056|Secondary|Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores|The NPI-Q assessed twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient’s caregiver who was asked if the behavior described is present in the patient. If “Yes”, the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.|Baseline, Week 12, and Week 24 (Follow up visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.||Scores on a scale||Standard Deviation|Mean
8273|NCT02097056|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. The mean change was analyzed by Wilcoxon’s signed rank test.|Baseline, Week 12, and Week 24 (Final visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.||Scores on a scale||Standard Deviation|Mean
8274|NCT02097056|Primary|Overall Summary of Adverse Events (AEs)|Safety of study drug was assessed by clinical laboratory assessments, vital signs, weight, 12-lead electrocardiogram (ECG), physical and neurological examination. Treatment-Emergent Adverse Events (TEAEs) were defined as any event not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Serious adverse events were defined as AEs that led to or were life-threatening, resulted in or prolonged hospitalization, caused important or long-lasting disability, caused congenital abnormality or malformation, or resulted in death. Adverse drug reactions were defined as any harmful or unintended reaction to study treatment and were considered possibly related or probably related to study drug. Specific AEs and SAEs due to changes in clinical laboratory assessments, vital signs, weight, ECG, and physical and neurological exam are listed in the safety section.|Baseline (Day 1) up to Week 24|Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment.||Percentage of participants|||Number
8275|NCT02097030|Secondary|Ocular Health - Biomicroscopy|The investigator’s objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)|3 Days Follow-up|Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study.||units on a scale||Standard Deviation|Mean
8276|NCT02097030|Secondary|Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up|||units on a scale||Standard Deviation|Mean
8277|NCT02097030|Secondary|Lens Fit and Performance - Fit Acceptance|The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up|||units on a scale||Standard Deviation|Mean
8278|NCT02097030|Secondary|Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).|Baseline and 3 days follow-up|||units on a scale||Standard Deviation|Mean
8279|NCT02097030|Secondary|Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)|Baseline and 3 day follow-up|||units on a scale||Standard Deviation|Mean
8280|NCT02097030|Secondary|Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);|Baseline and 3 days follow-up|||units on a scale||Standard Deviation|Mean
8281|NCT02097030|Secondary|Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).|Baseline and 3 days follow-up|||units on a scale||Standard Deviation|Mean
8282|NCT02097030|Secondary|Overall Satisfaction|Participant’s subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
8283|NCT02097030|Secondary|Overall Satisfaction, Dryness|Participant’s subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
8284|NCT02097030|Secondary|Overall Satisfaction, Handling|Participant’s subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
8285|NCT02097030|Secondary|Overall Satisfaction, Comfort|Participant’s subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
8286|NCT02097030|Secondary|Overall Satisfaction, Vision|Participant’s subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
8287|NCT02097030|Secondary|Subjective Response for Dryness|Participant’s subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
8288|NCT02097030|Secondary|Subjective Response for Handling (Insertion and Removal)|Participant’s subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|3 days follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
8289|NCT02097030|Secondary|Subjective Response for Insertion|Participant’s subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|Baseline|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
8290|NCT02097030|Secondary|Subjective Response for Vision|Participant’s subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
8291|NCT02097030|Secondary|Subjective Response for Comfort|Participant’s subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||units on a scale||Standard Deviation|Mean
8292|NCT02097030|Primary|Overall Lens Preference - Hydrogel vs. Filcon II 3|Participant’s subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|30 subjects||participants|||Number
8293|NCT02097030|Primary|Overall Lens Preference - All Study Lenses|Participant’s subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.||participants|||Number
8294|NCT02096835|Other Pre-specified|Need of Postoperative Metoclopramide|the number of patients who needed metoclopramide as a rescue medicine postoperatively|within 48h after operation|||participants|||Number
8295|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively|including retching and vomiting|within 24h after operation|||participants|||Number
8296|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively||within 24h after the operation|||participants|||Number
8297|NCT02096835|Primary|Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively|the total number including nausea, retching and vomiting within 24h after operation|within 24h after operation|||participants|||Number
8298|NCT02096744|Secondary|Cmax (Maximum Concentration of Clonidine in Plasma)|Cmax (maximum concentration of clonidine in plasma) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
8299|NCT02096744|Secondary|AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity)|AUC 0-inf(area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
26918|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)||Days 1-169|||nmol/L||95% Confidence Interval|Geometric Mean
8300|NCT02096744|Primary|Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7)|Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
8301|NCT02096744|Primary|AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h)|AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
8302|NCT02096731|Primary|Community Acquired Pneumonia|"The community acquired pneumonia rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.~Pt. = Patient"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.||No.of incident Pneumonia/1000 pt./year|||Number
8303|NCT02096731|Primary|Cardiac Arrhythmia|The cardiac arrhythmia (CA) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.||No. of incident CA/1000patients /year|||Number
8304|NCT02096731|Primary|Heart Failure|The heart failure (HF) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.||No. of incident HF/1000patients/year|||Number
8305|NCT02096731|Primary|Stroke|The stroke rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.||No. of incident stroke/1000patients/year|||Number
8306|NCT02096731|Primary|Myocardial Infarction|"The acute myocardial infarction (MI) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.~No. = Number"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.||No. of incident MI/1000patients/ year|||Number
8307|NCT02096718|Secondary|AUC 0-inf of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8308|NCT02096718|Primary|Cmax of Afatinib (BIBW 2992)|Maximum measured concentration of the analyte in plasma|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8309|NCT02096718|Primary|AUC 0-tz of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8310|NCT02096692|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|All participants who had measurable R-waves at both pre-MRI and and 1 Month Post-MRI.||percentage of participants||95% Confidence Interval|Number
8311|NCT02096692|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
8312|NCT02096692|Primary|MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
8363|NCT02094885|Primary|Hemostasis at the TBS at 10 Minutes Following the Completion of Treatment Application.||Intra-operative, 10 minutes following randomization|||percentage of patients||95% Confidence Interval|Number
8743|NCT02083263|Secondary|Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).|After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.|1 month||||||
8313|NCT02096679|Secondary|Pharmacokinetics of AZD9291 and Urine [14C] Total Radioactivity by Assessment of Percentage (or Fraction) of Actually Administered Dose / Radioactivity (Feu)|Pharmacokinetics of AZD9291 and urine [14C] total radioactivity by assessment of percentage (or fraction) of actually administered dose / radioactivity (feu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Percentage of administered dose||Standard Deviation|Mean
8314|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Urine [14C] Total Radioactivity by Assessment of Urine Concentration or Concentration Equivalent x Urine Volume (Aeu)|Pharmacokinetics of AZD9291, its metabolites and urine [14C] total radioactivity by assessment of urine concentration or concentration equivalent x urine volume (Aeu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nmol||Standard Deviation|Mean
8315|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve AUC|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve AUC, derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
8316|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of WBR to PR (AUC(WBR)/AUC(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of WBR to PR (AUC(WBR)/AUC(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
8317|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of Plasma AZD9291, AZD7550 or AZD5104 (PL) to Plasma Radioactivity (PR) AUC(PL)/AUC(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of plasma AZD9291, AZD7550 or AZD5104 (PL) to plasma radioactivity (PR) AUC(PL)/AUC(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
8318|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Whole Blood Radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of whole blood radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
8319|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Plasma AZD9291, AZ7550 or AZ5104 (PL) to Plasma Radioactivity (Cmax(PL)/Cmax(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of plasma AZD9291, AZ7550 or AZ5104 (PL) to plasma radioactivity (Cmax(PL)/Cmax(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
8320|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Metabolite to Parent Ratio, AZ7550 or AZ5104 (M/PCmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax metabolite to parent ratio, AZ7550 or AZ5104 (M/PCmax), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||ratio||Full Range|Geometric Mean
8321|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Metabolite to Parent Ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC Adjusted for Differences in Molecular Weight (M/PAUC)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC metabolite to parent ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC adjusted for differences in molecular weight (M/PAUC), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Ratio||Full Range|Geometric Mean
8322|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Rate Constant (λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination rate constant (λz), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||1/h||Full Range|Geometric Mean
8323|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Half-life (t1/2,λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination half-life (t1/2,λz), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||hour||Full Range|Mean
8324|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Volume of Distribution (Vz/F)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of apparent volume of distribution (Vz/F), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L||Full Range|Mean
8325|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Oral Clearance (CL/F)|Pharmacokinetics of AZD9291 plasma, whole blood and plasma [14C] radioactivity by assessment of apparent oral clearance (CL/F), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||L/h||Full Range|Mean
8326|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Lag Time Before Observation of Quantifiable Analyte Concentrations (Tlag)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of lag time before observation of quantifiable analyte concentrations (tlag), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||hours||Inter-Quartile Range|Median
8327|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Time to Cmax (Tmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of by assessment of time to Cmax (tmax), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||hours||Inter-Quartile Range|Median
8328|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Maximum Plasma Concentration (Cmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of maximum plasma concentration (Cmax), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM||Full Range|Geometric Mean
8329|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to 24 Hours AUC(0-24)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 24 hours AUC(0-24), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
8330|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of 72 Hours AUC(0-72)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 72 hours AUC(0-72), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
8364|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||units on a scale||Standard Deviation|Mean
8331|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration AUC(0-t)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-t), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||nM*h||Full Range|Geometric Mean
8332|NCT02096679|Primary|Percentage of Radioactive Dose of [14C] Radiolabelled AZD9291 Recovered in Urine, Faeces, and in Total.|The percentage of radioactive dose of [14C] radiolabelled AZD9291 recovered in urine, faeces, and in total, up to Day 85.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992. Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016. Faeces: 0-24h and then as per urine.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product||Percentage radioactive dose recovered||Standard Deviation|Mean
8333|NCT02096575|Secondary|Visual Analog Scale to Measure Anticipated Pain.|Anticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Anticipated pain assessed on average within 30 minutes before procedure|||units on a scale||Standard Deviation|Mean
8334|NCT02096575|Secondary|Pain Management Satisfaction|Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.|||units on a scale||Standard Deviation|Mean
8335|NCT02096575|Secondary|Visual Analog Scale for Post-procedure Pain|A quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale administered on average 20 minutes after procedure completed|||units on a scale||Standard Deviation|Mean
8336|NCT02096575|Secondary|Visual Analog Scale Score for Baseline Pain|A quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Baseline pain assessment on average within 30 minutes before procedure|||units on a scale||Standard Deviation|Mean
8337|NCT02096575|Primary|Visual Analog Pain Score for Mean Maximum Procedural Pain|"The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed.~Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain"|Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure|||units on a scale||Full Range|Mean
8338|NCT02096458|Primary|Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets|The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.|Day 1|The populations consisted of all enrolled participants.||Seconds||Full Range|Mean
8339|NCT02095691|Secondary|Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.||percentage of participants|||Number
8340|NCT02095691|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.||percentage of participants|||Number
8341|NCT02095691|Secondary|Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.||mmHg||Standard Deviation|Mean
8342|NCT02095691|Secondary|Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The safety analysis population consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
8365|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||units on a scale||Standard Deviation|Mean
26997|NCT01654276|Primary|Ambulatory Diastolic Blood Pressure|Diastolic BP by ambulatory blood pressure monitor.|6 months|||mmHg||Standard Deviation|Mean
8343|NCT02095691|Primary|Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.|Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
8344|NCT02095561|Secondary|HPV Positivity|Calculated as the percentage of women with positive HPV test over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within 6 months after the CHW visits|Population included in the HPV self-testing group to calculate positivity includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.||percentage of positive tests/tested wome|||Number
8345|NCT02095561|Secondary|CIN2+ Detection Rate|calculated as the percentage of women with histologically confirmed CIN2+ over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within one year after the CHW visits|Population included in the HPV self-testing group to calculate CIN2+ detection rate includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.||percentage of CIN2+/ women screened|||Number
8346|NCT02095561|Secondary|Acceptability|Defined as the proportion of women from the intervention group who were offered self-testing and accepted, as documented in the questionnaire, independently of if they ended up with a test in the information system.|within 6 months|||participants|||Number
8347|NCT02095561|Primary|Screening Uptake|The primary outcome was screening uptake, defined as: a) the proportion of participant women with any HPV test (self-test or HPV at health centers) in the information system, in the 6 months after the CHW visit, and b) the proportion of women in the intervention group with a self-test in SITAM, in the same 6 month period.|within 6 months after the intervention|||participants|||Number
8348|NCT02095223|Secondary|Change From Baseline in Quadriceps Hoffmann Reflex|We will record muscle reflex activity by delivering a short percutaneous (through the skin) electrical stimulation to femoral nerve located in the inguinal fold. We will measure the reflex response of the quadriceps with surface electromyography. Subjects will be positioned comfortably in a lying-down position on a treatment table. Stimuli will be delivered to the femoral nerve by increasing the intensity in small increments with a 10-sec rest interval after each stimulus, until the maximum H-reflex amplitude is recorded (Hmax). The H-reflex represents the proportion of the quadriceps motor neuron pool that is available for voluntary contraction and the M-wave represents the total volume of the quadriceps motor neuron pool and will be used to normalize the H-reflex recordings as H:M ratio. This measurement will be performed bilaterally.|Baseline and 14 days|This measure was exclude from the study protocol due to an issue with the equipment utilized to generate the electical pulse. No participants of this study completed the Hoffmann reflex testing protocol at baseline or follow-up visits.|||||
8349|NCT02095223|Primary|Change From Baseline in Quadriceps Central Activation Ratio|Subjects will be secured to a chair (Biodex multi-mode dynamometer) with their knees and hips bent to approximately 90-degrees. Subjects will perform a maximal, voluntary isometric knee extension contraction (MVIC) with continuous verbal encouragement from the tester. Once the MVIC reaches a plateau (representing subjects' maximal effort) an electrical stimulus will be manually triggered and delivered directly to the quadriceps through 2 stimulating electrodes which will be secured to the subjects' anterior thigh. The stimulus will cause the quadriceps to twitch resulting in a temporary increase in force production which we will measure. A ratio between the MVIC force and the highest force achieved due to the electrical stimulation will be calculated - this is called the central activation ratio.|Baseline and 14 days|||percentage change from baseline||Standard Deviation|Mean
8350|NCT02095158|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales|The investigator assessed the participant’s overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 6-hour evaluation period (hours 3 and 6) post-dose.|Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose|Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement.||percentage of participants|||Number
8351|NCT02095158|Primary|Percentage of Participants With Treatment-Related Adverse Events|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.|56 Weeks|Safety population included all participants who received at least 1 dose of study medication.||percentage of participants|||Number
8352|NCT02094937|Secondary|Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20)|Asthma control test is a five item questionnaire with each response rating from 1 to 5 (1 is severe and 5 is no event) of asthma events over previous 4-weeks. The questions were designed to be self-completed by the participant. The percentage of participants with ACT score >=20 at the end of the Period 2 were analyzed using a logistic regression model including covariates for baseline ACT score, gender, age and treatment group.|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.||Percentage of participants||95% Confidence Interval|Number
8395|NCT02094443|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment|4 weeks|Full Analysis Set||percentage of participants|||Number
26998|NCT01654276|Primary|Ambulatory Systolic Blood Pressure|Systolic BP by ambulatory blood pressure monitor.|6 months|||mmHg||Standard Deviation|Mean
8353|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2|The total ACT score is the sum of the scores attributed to the five questions, ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >=20 indicates well-controlled asthma. The questions were designed to be self-completed by the participant. Mean change from Baseline was calculated as ACT score at the end of Period 2 (Week 20) minus Baseline value. The Baseline value was the predose value at randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean(LSM)].|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.||Score on scale||Standard Error|Least Squares Mean
8354|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2|The time during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Participants who did not require inhalation of salbutamol (rescue medication) for 24-hours were captured with the help of a daily dairy, all participants were required to record use of rescue medication daily for day and night time separately on e-diary. Mean change from Baseline was calculated as percentage of rescue free 24 hour period during Period 2 (Week 9 to Week 20) minus Baseline value. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
8355|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2|Participants who were symptom free for 24-hours were assessed with the help of a daily Dairy. It included the details on daily asthma symptom scores ranging from 0 (no symptoms) to 5-symptoms so severe that participant could not perform normal activity [morning] or to 4-symptoms so severe that participants could not sleep at all [nightly]. Mean change from Baseline was calculated as percentage of symptom free 24 hours during Period 2 (Week 9 to Week 20) minus Baseline. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed||Percentage of symptom-free 24-h period||Standard Error|Least Squares Mean
8356|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2|Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter which determines person's ability to breathe out air. PEF was measured each morning and evening prior to study medication or any rescue salbutamol inhalation aerosol use, using an electronic peak flow meter. Mean change from Baseline was calculated as PEF value averaged during Period 2 (Week 9 to Week 20) minus Baseline. Data is presented separately for morning(AM) and evening(PM) assessments. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8) separately for morning and evening. Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified timepoints were analyzed||Liter per minute (L/min)||Standard Error|Least Squares Mean
8357|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2|FEV measures amount of air a person can exhale during a forced breath. The amount of air exhaled in one second of the forced breath is FEV1. Trough FEV1 was measured between 3pm and 11pm excluding Visit 1. Highest value from the three acceptable measurements were recorded. Change from Baseline was calculated as adjusted mean FEV1 value during Period 2 minus Baseline. The Baseline value was the predose value at the randomization (Visit 5: Week 8). Analysis of covariance (ANCOVA) Model was used with covariates of baseline FEV1, gender, age and treatment group. The adjusted mean from this model is presented [least square mean (LSM)].|Week 20|ITT population. Number of participants available for the last post-baseline value during Period 2 were used for analysis.||Liter||Standard Error|Least Squares Mean
8358|NCT02094937|Primary|Proportion of Participants With 'Well-controlled Asthma' at the End of Period 2|Asthma symptom scores(SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity[morning] or to 4-symptoms so severe that par could not sleep at all[nightly]. “Well-controlled asthma” was defined as having no exacerbation/asthma worsening, no night-time symptoms, a best pre-bronchodilator forced expiratory volume in 1 second ≥80% at clinic, and ≥2 per week of: daytime symptoms on ≤1 day, rescue use on ≤1 day, or morning peak expiratory flow ≥80% of the best effort value. “Well-controlled asthma” at the end of period 2 was assessed in the week prior to Visit 11 (Week 20). Proportion of participants were calculated as the number of participants with “well-controlled asthma” divided by total number participants excluding withdrawals prior to visit 11 (end of period 2) other than asthma worsening/exacerbation. A Logistic Regression Model was used with covariates of Baseline FEV1, gender, age and treatment group.|Week 20|ITT population. Participants who withdrew prior to Visit 11 for the reasons other than exacerbation were excluded.||Percentage of Participants||95% Confidence Interval|Number
8359|NCT02094937|Primary|"Percentage of Participants (Par) Withdrawn From the Study Due to Poorly-controlled Asthma During Period 2"|Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity [morning] or to 4-symptoms so severe that par could not sleep at all [nightly]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF <80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) < 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced.|From Week 9 to Week 20|Intent-to-treat (ITT) population defined as participants randomized to treatment and who received at least one dose of randomized study medication in Period 2.||Percentage of Participants||95% Confidence Interval|Number
8360|NCT02094885|Secondary|Incidence of Potential Bleeding-related Adverse Events.||30-days follow-up|||percentage of participants||95% Confidence Interval|Number
8361|NCT02094885|Secondary|Incidence of Treatment Failures.||Intra-operative, 10 minutes following randomization|||participants|||Number
8366|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) – Filcon II 3 and Nelfilcon A|"The ophthalmologist’s objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).~N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||percentage of the area of each zone||Standard Deviation|Mean
8367|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) – Filcon II 3 and Etafilcon A|"The ophthalmologist’s objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).~N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||percentage of the area of each zone||Standard Deviation|Mean
8368|NCT02094677|Secondary|High Contrast Visual Acuity – Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||logMAR||Standard Deviation|Mean
8369|NCT02094677|Secondary|High Contrast Visual Acuity – Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||logMAR||Standard Deviation|Mean
8370|NCT02094677|Secondary|Lens Surface Deposition – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||units on a scale||Standard Deviation|Mean
8371|NCT02094677|Secondary|Lens Surface Deposition – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||units on a scale||Standard Deviation|Mean
8372|NCT02094677|Secondary|Lens Fit, Tightness – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||percentage of tightness||Standard Deviation|Mean
8373|NCT02094677|Secondary|Lens Fit, Tightness – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||percentage of tightness||Standard Deviation|Mean
8374|NCT02094677|Secondary|Lens Fit, Post-Blink Movement – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||mm steps||Standard Deviation|Mean
8375|NCT02094677|Secondary|Lens Fit, Post-Blink Movement – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||mm steps||Standard Deviation|Mean
8376|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|After 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||participants|||Number
8377|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|Baseline|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||participants|||Number
8378|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||participants|||Number
8379|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|"The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).~N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||participants|||Number
8396|NCT02094443|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment|2 weeks|Full Analysis Set||percentage of participants|||Number
26999|NCT01654276|Primary|Serum Creatinine||6 months|||mg/dl||Standard Deviation|Mean
8380|NCT02094677|Secondary|Lens Wettability – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.||units on a scale||Standard Deviation|Mean
8381|NCT02094677|Secondary|Lens Wettability – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.||units on a scale||Standard Deviation|Mean
8382|NCT02094677|Secondary|Lens Handling (Removal) – Filcon II 3 and Nelfilcon A|Participant’s subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8383|NCT02094677|Secondary|Lens Handling (Removal) – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8384|NCT02094677|Secondary|Lens Handling – Filcon II 3 and Nelfilcon A|Participant’s subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8385|NCT02094677|Secondary|Lens Handling – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8386|NCT02094677|Secondary|Lens Dryness - Filcon II 3 and Nelfilcon A|Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8387|NCT02094677|Secondary|Lens Dryness – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8388|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Nelficon A|Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8389|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Etafilcon A|Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.||units on a scale||Standard Deviation|Mean
8390|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|6 hours|||participants|||Number
8391|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|3 hours|||participants|||Number
8392|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|"Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.~(5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A)."|Baseline visit|||participants|||Number
8393|NCT02094443|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End|ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
8394|NCT02094443|Secondary|Percentage of Participants With End of Treatment Response (ETR)|ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued).|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
8397|NCT02094443|Secondary|Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment|SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.|Up to 24 weeks posttreatment|Full Analysis Set||percentage of participants|||Number
8398|NCT02094443|Primary|Change From Baseline in Alanine Aminotransferase (ALT) at Week 12|ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.|Baseline, Week 12|Participants in the safety set with available data at the given time point||U/L||Standard Deviation|Mean
8399|NCT02094443|Primary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12|The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.|Baseline, Week 12|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
8400|NCT02094326|Secondary|Exposure Time of Methotrexate|methotrexate|6 years|||months||Standard Deviation|Mean
8401|NCT02094326|Secondary|Percentage of Patients Who Receive Subcutaneous Methotrexate||6 years|||percentage of participants||95% Confidence Interval|Number
8402|NCT02094326|Secondary|Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment||6 years|||percentage of participants||95% Confidence Interval|Number
8403|NCT02094326|Secondary|Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal||6 years|||percentage of participants||95% Confidence Interval|Number
8404|NCT02094326|Secondary|Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question||6 years|||percentage of participants||95% Confidence Interval|Number
8405|NCT02094326|Primary|Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice||6 years|||percentage of participants||95% Confidence Interval|Number
8406|NCT02094300|Primary|Number of Patients With Major Complications|Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.|30 days|There were 8 patients experienced 30-day major complications.||participants|||Number
8407|NCT02094261|Secondary|Progression-Free Survival (PFS)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment.||months||95% Confidence Interval|Median
8408|NCT02094261|Secondary|Disease Control Rate (DCR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.||% of participants||95% Confidence Interval|Number
8409|NCT02094261|Secondary|Duration of Response (DoR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.||months||Full Range|Median
8410|NCT02094261|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.||% of participants||95% Confidence Interval|Number
8440|NCT02093702|Primary|Mean Change in Diastolic Blood Pressure||Baseline and 12 months|||mm Hg||Full Range|Mean
8441|NCT02093702|Primary|Mean Change in Total Cholesterol: HDL-C Ratio||Baseline and 12 months|||mmol/L:mmol/L||Full Range|Mean
8442|NCT02093702|Primary|Mean Change in Triglycerides (TGs)||Baseline and 12 months|||mmol/L||Full Range|Mean
8411|NCT02093923|Other Pre-specified|HAE Attack Rate Per Week|The pre-specified, primary efficacy analysis was based on subjects in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Days 8 to 50; predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and subject is a random effect in the GEE model with independence working correlation structure.|Baseline, Day 8 to Day 50|Only subjects who had a baseline attack rate of at least 2 attacks in the last 3 months prior to enrollment are included.||attacks/week||Standard Error|Mean
8412|NCT02093923|Secondary|Terminal Elimination Half-life (t1/2)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||days||Standard Deviation|Mean
8413|NCT02093923|Secondary|Apparent Volume of Distribution (Vd/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||liters||Standard Deviation|Mean
8414|NCT02093923|Secondary|Apparent Clearance (CL/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||liters/day||Standard Deviation|Mean
8415|NCT02093923|Secondary|Area Under the Plasma Concentration-time Curve (AUC)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||day*ng/mL||Standard Deviation|Mean
8416|NCT02093923|Secondary|Time to Maximum Plasma Concentration (Tmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||days||Standard Deviation|Mean
8417|NCT02093923|Secondary|Maximum Plasma Concentration (Cmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.||ng/mL||Standard Deviation|Mean
8418|NCT02093923|Primary|Proportion of Patients With Serious Adverse Events|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening experience: “life-threatening” referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.~Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.~Resulted in persistent or significant disability or incapacity.~Was a congenital anomaly or birth defect.~Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with serious adverse events.||percentage of participants|||Number
8419|NCT02093923|Primary|Number of Patients With Serious Adverse Events (SAEs)|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening experience: “life-threatening” referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.~Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.~Resulted in persistent or significant disability or incapacity.~Was a congenital anomaly or birth defect.~Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with serious adverse events||participants|||Number
8420|NCT02093923|Primary|Proportion of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with Treatment-Emergent Adverse Events (TEAE)||percentage of participants|||Number
8421|NCT02093923|Primary|Number of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with Treatment-Emergent Adverse Events (TEAE).||participants|||Number
8443|NCT02093702|Primary|Mean Change in LDL-C||Baseline and 12 months|||mmol/L||Full Range|Mean
8422|NCT02093897|Secondary|Number of Subjects With Inhibitor Formation to rVIII-SingleChain|The number of subjects who develop inhibitors to rVIII-SingleChain, defined as a rVIII-SingleChain antibody titer of at least 0.6 Bethesda Units (BU) per mL after receiving study drug.|At screening, then after dosing at approximately monthly intervals for 6 months, then every 3 months until reaching 50 EDs, and at the end of study visit (up to approximately 12 months).|||participants|||Number
8423|NCT02093897|Secondary|Clearance (Cl) of rVIII-SingleChain|Clearance (Cl) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population||mL/h/kg||Standard Deviation|Mean
8424|NCT02093897|Secondary|Area Under the Concentration Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUC0–t), baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population||IU*h/dL||Standard Deviation|Mean
8425|NCT02093897|Secondary|Half-life (t1/2) of rVIII-SingleChain|Half-life (t1/2) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population||hour||Standard Deviation|Mean
8426|NCT02093897|Secondary|Incremental Recovery|Incremental recovery expressed as (IU/dL)/(IU/kg) corrected for subject's predose plasma FVIII activity measured using the chromogenic substrate assay.|At 1 hour after the start of infusion|PK Population||(IU/dL)/(IU/kg)||Standard Deviation|Mean
8427|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Year||Up to 1 year|Subjects assigned to the on-demand treatment regimen.||number of infusions per subject per year||Full Range|Median
8428|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Month||Up to 1 year|Subjects assigned to the on-demand treatment regimen.||number of infusion per subject per month||Full Range|Median
8429|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Bleeding Event||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||IU/kg per event||Full Range|Median
8430|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Year||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||IU/kg per subject per year||Full Range|Median
8431|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Month||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||IU/kg per subject per month||Full Range|Median
8432|NCT02093897|Secondary|Percentage of Bleeding Episodes Requiring 1, 2, 3, or More Than 3 Infusions of rVIII-SingleChain to Achieve Hemostasis.||Up to 1 year|Efficacy Population||Percentage (%) of bleeding episodes|Number of Treated Bleeds||Number
8433|NCT02093897|Secondary|Annualized Bleeding Rate|The annualized bleeding rate was defined as the number of bleeding episodes requiring treatment divided by the efficacy evaluation period in days, x 365.25, and is presented separately for the on-demand regimen and the prophylaxis regimens.|Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).||Treated bleeding episodes per year||Inter-Quartile Range|Median
8434|NCT02093897|Primary|Treatment Success|"Rate of treatment success where treatment success of a bleeding episode is defined as a rating of excellent or good based on the investigator's overall clinical assessment of hemostatic efficacy (using a 4-point scale of excellent, good, moderate or poor/no response) on the on-demand and prophylaxis regimens combined. The rate of success was based on the number of treated bleeding events; there were 347 treated bleeding events in the Efficacy Population."|Up to 1 year|Efficacy Population||Percentage of treated bleeding events|Treated bleeding events|95% Confidence Interval|Number
8435|NCT02093819|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
8436|NCT02093819|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax (maximum measured concentration of the analyte in plasma)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
8437|NCT02093819|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events|AEs were recorded throughout the trial|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.||percentage of participants|||Number
8438|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.|Baseline and 12 months|||sessions/week||Full Range|Mean
8439|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.|Baseline and 12 months|||minutes/week||Full Range|Mean
8450|NCT02093390|Secondary|Plasma Trough Concentrations for Atorvastatin|Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
8451|NCT02093390|Secondary|Plasma Trough Concentrations for Fluconazole|Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
8452|NCT02093390|Secondary|Fraction Excreted Unchanged (Fe) of TAK-385|Fraction of TAK-385 excreted in the urine unchanged.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||percent of TAK-385||Standard Deviation|Mean
8453|NCT02093390|Secondary|Apparent Total Body Clearance (CL/F) of TAK-385||Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||liters/hour||Standard Deviation|Mean
8454|NCT02093390|Secondary|Terminal Disposition Half-life (t1/2) of TAK-385|Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||hours||Standard Deviation|Mean
8455|NCT02093390|Secondary|AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385|Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
8456|NCT02093390|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385|Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||hours||Full Range|Median
8457|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Laboratory Tests|Blood samples were collected for analysis of clinical chemistry and hematological parameters and urine samples were obtained for urinalysis. Clinical laboratory evaluations were performed at central and /local laboratories.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.||participants|||Number
8458|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings|A 12-lead ECG was administered on Days 1,9,10,11,15.|Baseline and First dose of study drug through Day 15|||participants|||Number
8459|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Vital Signs|Vital sign measurements included oral temperature, heart rate, supine (after 3 to 5 minutes in this position) and standing (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.||participants|||Number
8460|NCT02093390|Secondary|Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.||participants|||Number
8461|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10|Area under the plasma concentration-time curve from time 0 to infinity.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
8462|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1|Area under the plasma concentration-time curve from time 0 to infinity.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
8463|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
8464|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng*hr/mL||Standard Deviation|Mean
8490|NCT02092662|Secondary|Muscle Co-activation Index.|Assessed by surface electromyography device. Indicate for the level by which muscles contract at the same time and amplitude. It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.||||||
8465|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
8466|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 (Predose and multiple time points up to 120 hours postdose)|Pharmacokinetic (PK)-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.||ng/mL||Standard Deviation|Mean
8467|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
8468|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - AUC0-τ|Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
8469|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
8470|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - AUC0-τ|Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
8471|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
8472|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ|Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||microgram x hour/millilitre (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
8473|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
8474|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - Cmax ss|Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
8475|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
8476|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - Cmax ss|Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||micrograms per millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
8477|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
8478|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - Cmax ss|Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
8491|NCT02092662|Primary|Fugl-Meyer Assessment.|zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|||units on a scale||Standard Deviation|Mean
8479|NCT02092961|Other Pre-specified|DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
8480|NCT02092961|Other Pre-specified|OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS erosions score was based on 25 joints and ranged from 0 to 250 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
8481|NCT02092961|Other Pre-specified|Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|Joint space narrowing score was based on 20 joints, scored from MRI images and ranged from 0 to 80 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, JSN = joint space narrowing, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
8482|NCT02092961|Other Pre-specified|OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS osteitis score was based on 25 joints, scored from MRI images, and ranged from 0 to 75 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
8483|NCT02092961|Primary|OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.||Units on a scale||Inter-Quartile Range|Median
8484|NCT02092857|Primary|Number of Antigen-presenting B Cells||10 weeks|||percentage of CD20+ B cells|||Number
8485|NCT02092662|Secondary|Handwriting Off-paper Time.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The time the pen is on air is measured. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...||||||
8486|NCT02092662|Secondary|Handwriting Pressure.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...||||||
8487|NCT02092662|Secondary|% Maximum Voluntary Contraction.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.||||||
8488|NCT02092662|Primary|Muscle Onset Time.|Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.|the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1|||seconds||Standard Deviation|Mean
8489|NCT02092662|Secondary|Handwriting Velocity|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.|T1 at the beginning of the hospital stay and follow up at T2 one month later.||||||
8492|NCT02092649|Secondary|Change in Fasted Blood Triglyceride Concentration From Baseline||Baseline, 12 weeks|||percent change||Standard Deviation|Mean
8499|NCT02092610|Secondary|Soft Tissue Status|"To evaluate the status of the soft tissue at the implant site.~The scale Holgers Index 4 is designed to capture signs and symptoms of inflammation or infection at the site of implantation. The scale should be completed at the visit.~The scale consists of the following steps:~0. No irritation. Epidermal debris removed, if present~Slight redness. Local temporary treatment, if needed~Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated~Reddish and moist; sometimes granulations tissue, revision surgery is indicated~Removal of the abutment/implant necessary due to infection R. Removal of abutment/implant for reasons not related to skin problems"|At the single 60 months visit|Five year follow up population||% of participants|||Number
8500|NCT02092610|Secondary|Longterm Survival of Implant|"To compare the long term survival of the novel implant and abutment and the standard implant and abutment in the Baha system.~All patients will be asked if they have experienced any implant osseointegration problems which would have made the implant to get loose. The time from implant implantation until implant loss or removal will be collected. In case of implant removal, reason for removal shall be recorded."|At the single 60 months visit|Survival population, all patients in the ITT population in the original study CAG5173 (all randomized patients who get surgery).||% survival rate of implants|||Number
8501|NCT02092610|Primary|Implant Stability|To show superiority of the novel implant compared to standard implants regarding stability of the implants measured as ISQ values at the abutment level. The ISQ value ranges from 1 to 100, the higher ISQ value, the higher the implant stabilty. Mean AUC 0-60 months ISQ represents a weighted average of the implant stability during the 60 months from start of the CAG5173 study to the measurement in this study CBAS5562. The ISQ 5 years value represents the single ISQ measurment at 5 years.|At the single 60 months visit|The 5 year follow up population consisted of the patients in the ITT population (all randomized subjects who received surgery) in the CAG5173 study who attended this study which was a 5-year follow up visit.||ISQ scores||Standard Deviation|Mean
8502|NCT02092441|Other Pre-specified|Satisfaction Measured on a 5-point Likert Scale|"Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 (completely unsatisfied) to 5 (completely satisfied)"|10 minutes post intervention|||5 point Likert Scale||Inter-Quartile Range|Median
8503|NCT02092441|Secondary|Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention|"Scale ranges from 0 (no pain) to 10 (worst pain imaginable)"|10 minutes post intervention|||VNRS||Inter-Quartile Range|Median
8504|NCT02092441|Primary|Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention|"Primary outcome is nausea and vomiting measured on a scale from 0 (no nausea) to 10 (worst nausea imaginable) Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention."|10 minutes post intervention|||VNRS||Inter-Quartile Range|Median
8505|NCT02092415|Primary|Muscle Perfusion|Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.|baseline and 1 min post occlusion|||IU/s||Standard Error|Mean
8506|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA <LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.||Percentage of participants||95% Confidence Interval|Number
8507|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA <LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.||Percentage of participants||95% Confidence Interval|Number
8508|NCT02092350|Primary|Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 12|The APaT population includes all enrolled participants who received at least one dose of study drug.||Participants|||Number
8509|NCT02092350|Primary|Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 14|The All Participants as Treated (APaT) population includes all enrolled participants who received at least one dose of study drug.||Participants|||Number
8510|NCT02092350|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)|The modified Full Analysis set (mFAS) includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.||Percentage of participants||95% Confidence Interval|Number
8511|NCT02092311|Other Pre-specified|Post-varicocelectomy Testicular Atrophy|development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery|6months|||Participants|||Number
8512|NCT02092311|Secondary|Post-varicocelectomy Hydrocele|Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery|6months|||Participants|||Number
8513|NCT02092311|Primary|Recurrent Varicocele|post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery|6 months|||participants|||Number
9630|NCT02041520|Secondary|Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||copies/ml||95% Confidence Interval|Mean
8517|NCT02091856|Primary|Beck Depression Inventory II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents the measure of depression at 6 month after the intervention."|Absolute values (average score) of BDI-II at 37 weeks (follow-up)|Only 10 participants from the C-CBT and 9 participants from the R-CBT completed the follow-up assessment questionnaires. Participants from the Wailt-List Control Group were lost at follow-up.||units on a scale||Standard Deviation|Mean
8518|NCT02091856|Secondary|Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR)|"The Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents a secondary outcome measure for depression taken immediately after the intervention."|Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
8519|NCT02091856|Secondary|Quality of Life Inventory (QOLI)|"The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality.~This represents the post-intervention assessment."|Absolute values (average score) of QOLI at 11 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
8520|NCT02091856|Secondary|Beck Anxiety Inventory (BAI)|"The Beck Anxiety Inventory (BAI) was designed to measure participant’s level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.~This represent the post-intervention assessment."|Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
8521|NCT02091856|Primary|Beck Depression Inventory-II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents the post-intervention assessment."|Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
8522|NCT02091778|Primary|Change in Peri-wound Skin|Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin|12 weeks|number of patients with healthy/intact peri-wound skin that increased from baseline to final visit. (From 6 to 14)||participants|||Number
8523|NCT02091752|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores||Baseline, Day 1, Week 8, Week 12, Week 16, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8524|NCT02091752|Secondary|Patient Global Impression of Change (PGIC) Score||Week 1, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8525|NCT02091752|Secondary|Change From Baseline in MPN-SAF TSS Score||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8526|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS)||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8527|NCT02091752|Secondary|Change From Baseline in Spleen Length and Spleen Volume||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8528|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8529|NCT02091752|Secondary|Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8530|NCT02091752|Primary|Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.|||||
8531|NCT02091726|Secondary|Participant Fully Satisfied and Would Recommend to Friends and Family|Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?|4 weeks|104 men came for their 4-week followup, but 1 man did not complete the satisfaction questions.||participants|||Number
8532|NCT02091726|Secondary|Cosmetic Result Excellent|Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line|4 weeks|104 men came for their 4-week followup but the doctor(s) failed to note the cosmetic result in 2 men.||participants|||Number
8533|NCT02091726|Secondary|Wound Separation|Wound separation caused by adhesive failure (minor --requires no treatment)|4 weeks|Wound dehiscence < 2 cm. None required treatment. There were no participants with wound dehiscence > 2 cm.||participants|||Number
8534|NCT02091726|Secondary|Completely Healed at 4 Weeks|Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present|4 weeks|||participants|||Number
8535|NCT02091726|Primary|Time for Procedure|Intraoperative time, total|1 hour|||Min||Inter-Quartile Range|Median
8536|NCT02091466|Primary|Maternal Hypothermia|Hypothermia was measured by means of tympanic temperatures.|60 minutes|Sample size was calculated to be 20 subjects in each group to ensure that a difference of 0.5ºC at 60 minutes could be detected at significance level of 5% with a statistical power of 90%, assuming the standard deviation of differences to be 0.5ºC, considering a temperature below 36.0ºC could be considered hypothermia||Centigrades||Standard Deviation|Mean
8537|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
8538|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants|||Number
27000|NCT01654276|Primary|Serum Uric Acid||6 months|||mg/dl||Standard Deviation|Mean
8545|NCT02091414|Primary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week|Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.|Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population||percentage of participants||95% Confidence Interval|Number
8546|NCT02090855|Secondary|Specificity Percentage of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.||Percentage of Specificity|||Number
8547|NCT02090855|Primary|Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.||Percent of Sensitivity|||Number
8548|NCT02090855|Secondary|Number of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.||Number of Blinded Image Intrepretations|||Number
8549|NCT02090855|Primary|The Number of Abnormal Blinded Visual PET Image Interpretations.|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.||Number of Blinded Image Interpretations|||Number
8550|NCT02090777|Primary|Glaucoma Medication Adherence|Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage. The average of the participants percentage of time they adhered to using the medication will be reported.|6 Months|||percentage of adherence time||Standard Deviation|Mean
8551|NCT02090764|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.~Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.~The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain."|Visit 3 (Day 6-7)|"Intent-to-treat clinical (ITTC) population was defined as all randomized patients.~The % of clinical success for the treatment comparison were calculated excluding the unable to determine: OZN (112/203), PLB (78/199)"||percentage of Participants|||Number
8552|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS|For the EQ-VAS, the participant was instructed to draw a line on a 20-cm vertical scale at the point that best describes his or her own health, where 0 represents the “worst imaginable health state” and 100 represents the “best imaginable health state.”|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8553|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8554|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8597|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the Last Acute Intravenous (iv) Administration That Occurred Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.|||||
27001|NCT01654276|Primary|BMI||6 months|||kg/m^2||Standard Deviation|Mean
8555|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8556|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8557|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8558|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8559|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or early termination (ET)|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
8560|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
8561|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
8562|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
11613|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-6|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.|Baseline and 3 months||||||
8563|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
8564|NCT02090413|Secondary|Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48|Participant-reported flushing events (which include redness, warmth, tingling, and/or itching of the skin) during Weeks 13 to 48 of treatment were recorded in the CRF.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||participants|||Number
8565|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). For participants with more than 1 flushing event during a visit interval, the average duration for the visit interval was used.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||hours||Standard Deviation|Mean
8566|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MGFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 12|Although designated as a secondary endpoint, the duration of flushing events based on MGFSS could not be calculated because specific flushing events with start and end times was not captured in the MGFSS.|||||
8567|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||units on a scale||Standard Deviation|Mean
8568|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||units on a scale||Standard Deviation|Mean
8569|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
8570|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.||percentage of participants|||Number
8571|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||units on a scale||Standard Deviation|Mean
8572|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||units on a scale||Standard Deviation|Mean
8573|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
8574|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the first 4 weeks treatment, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants evaluable at given time point.||percentage of participants|||Number
8575|NCT02090088|Secondary|Number of Participants With Adverse Events||Throughout pregnancy and for up to 6 weeks after delivery|All enrolled participants||participants|||Number
8576|NCT02090088|Secondary|Number of Infants With Adverse Events|In the first year of life, the incidence of all serious adverse events, as well as of nevi (birthmarks) and angiomata (benign tumors with blood vessels or lymph vessels), among infants whose mothers received Nplate® therapy at any time during the pregnancy.|12 months from birth|Children born to enrolled participants during the study||infants|||Number
8577|NCT02090088|Secondary|Number of Children Born With Intrauterine Growth Restriction|Number of children born with intrauterine growth restriction (weight, length or head circumference less than tenth percentile for sex and gestational age) among mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study||children|||Number
8578|NCT02090088|Secondary|Number of Children With Preterm Birth or Low Birth Weight|Number of children with preterm birth (<37 weeks gestation) or low birth weight (<2,500 grams) among children born to mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study||children|||Number
8579|NCT02090088|Secondary|Number of Participants With Spontaneous and Elective Abortions or Stillbirths|Number of each of spontaneous abortions, elective abortions, and stillbirths among mothers who received Nplate® therapy at any time during the pregnancy.|9 months (during pregnancy)|All enrolled participants||participants|||Number
8580|NCT02090088|Secondary|Number of Children Born With a Specific Pattern of Minor Birth Defects|Only those infants who have received medical evaluation and who have three or more minor defects will be considered “affected” for purposes of the evaluation of a pattern of minor defects.|At birth|Children born with 3 or more minor birth defects|||||
8581|NCT02090088|Secondary|Number of Children Born With Any 3 or More Minor Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A minor structural defect is defined as a defect which occurs in less than 4% of the population but which has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes).|At birth|Children born to enrolled participants during the study||children|||Number
8582|NCT02090088|Primary|Number of Children Born With Major Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (eg, a cleft lip), require surgery, or are life-limiting).|At birth|Children born to enrolled participants during the study||children|||Number
8583|NCT02089347|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT BIK® Vaccine|Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling >100 mm. Grade 3 systemic reactions: Fever, >39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed in the Safety Analysis Set.||Percentage of Participants|||Number
8584|NCT02089347|Secondary|Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT BIK® Vaccine|Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration was assessed in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
8607|NCT02087774|Primary|Change From Baseline to After Intervention for After-Exercise Heart Rate|"Immediate cool-down, after-exercise heart rate was taken.~Difference in heart rate from baseline measurements is reported"|Baseline to 12 weeks later|||beats per minute||95% Confidence Interval|Mean
8585|NCT02089347|Secondary|Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT BIK® Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).~Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population||Percentage of Participants|||Number
8586|NCT02089347|Secondary|Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT BIK® Vaccine|Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration were assessed in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
8587|NCT02089347|Secondary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT BIK® Vaccine|"Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
8588|NCT02089347|Secondary|Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT BIK® Vaccine|"Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Pre-vaccination (Day 0)|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
8589|NCT02089347|Primary|Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT BIK® Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).~Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population||Percentage of Participants|||Number
8590|NCT02089347|Primary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT BIK® Vaccine|"Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
8591|NCT02089347|Primary|Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT BIK®|"Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Post-vaccination booster response was determined in the per-protocol population||Percentage of Participants|||Number
8592|NCT02089191|Secondary|Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.|Hour 12|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.||percent distortion per second||Standard Deviation|Mean
8593|NCT02089191|Primary|Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.|Day 1, Hour 12, each period|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.||seconds||Standard Deviation|Mean
8594|NCT02089113|Primary|Absence of Cells in Anterior Chamber of the Study Eye||Day 14|||percentage of participants|||Number
8595|NCT02088957|Secondary|Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration|This variable was not analyzed and no results are available.|||||
8596|NCT02088957|Secondary|Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration||Between 15 minutes to 12 hours after first acute iv administration|This variable was not analyzed and no results are available.|||||
8799|NCT02081001|Secondary|Glucose AUC|Area under the plasma concentration time curve for glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||(mg/dl)*minutes||Standard Deviation|Mean
8598|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration on Day 1|This variable was not analyzed and no results are available.|||||
8599|NCT02088957|Secondary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.|||||
8600|NCT02088957|Primary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.|||||
8601|NCT02087943|Secondary|Number of Participants With TEAEs During the Apremilast Exposure Period|A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg|Safety population includes all participants who received at least one dose of IP. These were Apremilast participants as treated.||participants|||Number
8602|NCT02087943|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period|A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 12|Safety population includes all participants who received at least one dose of IP.||participants|||Number
8603|NCT02087943|Secondary|The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4|The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 (“no pruritus”) to 10 (“the worst pruritus imaginable”). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.|Baseline to Week 4|All participants who were randomized as specified in the protocol and who received at least one dose of IP with a baseline and at least 1 postbaseline value at or before Week 4 were included. LOCF.||percent change||Standard Error|Least Squares Mean
8604|NCT02087943|Secondary|Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12|The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.|Baseline to Week 12|ITT includes all participants who were randomized as specified in the protocol and received at least one dose of IP. LOCF.||percentage of participants|||Number
8605|NCT02087943|Secondary|Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician’s Global Assessment of Acute Signs (sPGA-A) at Week 12.|The sPGA-A is intended to assess the global severities (ie, a “visual average” integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4).|Baseline to Week 12|ITT includes all participants who were randomized as specified per protocol and received at least one dose of IP. LOCF for missing data handling.||percentage of participants|||Number
8606|NCT02087943|Primary|Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.|EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.|Baseline to Week 12|All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12.||percent change||Standard Error|Least Squares Mean
8854|NCT02079519|Secondary|Overall Survival|Overall survival was defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 1 year)||||||
8608|NCT02087774|Primary|Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes|"Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed.~Difference in laps completed from baseline was taken."|Baseline to 12 weeks later|||Difference in Laps Completed||95% Confidence Interval|Mean
8609|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores while standing in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.~Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days|||units on a scale||Standard Deviation|Mean
8610|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores at rest in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.~Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days|||units on a scale||Standard Deviation|Mean
8611|NCT02087748|Primary|Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours|"The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days|||units on a scale||Standard Deviation|Mean
8612|NCT02087670|Secondary|Oxygen Consumption||8 weeks|||ml/min||Standard Deviation|Mean
8613|NCT02087670|Primary|Natriuretic Brain Pro-peptid||8 weeks|||pg/ml||Full Range|Median
8614|NCT02087176|Primary|Objective Response Rate|Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.|Up to 20 months|Thirty-two (32) subjects were enrolled in Part A, but the study was terminated early. Patients on-study at the time the study was terminated have been censored.||Percentage of Participants||90% Confidence Interval|Number
8615|NCT02087176|Secondary|Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel|Venous blood samples taken for determination of AZD1775, metabolites of 1775 on Cycle 1, Day 1 pre-dose and 2 hours post dose, Cycle 2 Day 1 pre-dose and 2 hours post dose, and Cycle 4 pre-dose and 2 hours post dose. However, the study was terminated early by the sponsor; therefore, pharmacokinetic data were not collected.|Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity|The study was terminated early by the sponsor. Pharmacokinetic data have not been analyzed.|||||
8616|NCT02087059|Secondary|Summary of Summary of EORTC QLQ-C30 Responses by Time|The QLQ-C30 version 1.0 (QLQ-C30) incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|24 weeks|FAS||units on a scale||Standard Deviation|Mean
8617|NCT02087059|Secondary|Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time|The modified MFSAF v2.0 diary captures a patient's symptom severity on a scale of 0 (absent) to 10 (worst imaginable),with a maximal summary score of 60|24 weeks|||score on a scale||Standard Deviation|Mean
8618|NCT02087059|Secondary|Charge in Spleen Size From Baseline up to the Specified Week|Number of patients with spleen length reduced by ≥ 50% up to specified week|Baseline, 24 weeks|||particiapants|||Number
8619|NCT02087059|Secondary|Charge in Spleen Size From Baseline at Specified Week|Number of patients with spleen length reduced by ≥ 50% at specified week|Baseline, 24 weeks|||particiapants|||Number
8620|NCT02087059|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24 weeks|||Participants|||Number
8621|NCT02086708|Primary|Measure Liver Elasticity Value Using Sonoelastography.|Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).|Day one|||kPa||95% Confidence Interval|Mean
8855|NCT02079519|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of study drug to disease progression or death due to progression.|Baseline to the end of the study (up to 1 year)||||||
8622|NCT02086591|Other Pre-specified|Exploratory Objective|To investigate change in plasma matrix metalloproteinase 9 (MMP9) levels as a biomarker of treatment response; to assess plasma matrix metalloproteinase 9 (MMP9) expression by immunohistochemistry (IHC) and correlate to response in order to test the hypothesis that elevated intratumoral levels of plasma matrix metalloproteinase 9 (MMP9) can predict response to doxycycline. To assess activation/expression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kb) and Signal transducer and activator of transcription 3 (STAT 3) pathways in archived tumor by immunohistochemistry (IHC) to predict response or resistance to doxycycline.|One year|No data displayed because Outcome Measure has zero total participants analyzed|||||
8623|NCT02086591|Secondary|Percentage of Patients With Progression Free Survival|Progression free survival is defined as the percentage of patients with stable disease or no death. Stable disease is defined as less than a partial response but is not progressive disease. Partial Response (PR)-At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses as determined byFDG-PET for CT scan. No increase should be observed in the size of other nodes, liver, or spleen. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients should be considered partial responders.|One year|Data was collected on all patients who were enrolled.||percentage of participants|||Number
8624|NCT02086591|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of patients with disease progression. Progression is defined as:~Appearance of a new lesion on fluorodeoxyglucose (FDG)-positron emission tomography or computerized tomography~≥50% increase in sum of the product of the node dimensions (SPD) of more than one node or in greatest diameter of any previously identified node >1 cm in its short axis from nadir.~To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Three months|||percentage of participants|||Number
8625|NCT02085720|Secondary|Sleep and Health Questionnaire Result||1 year|||% of participants|||Number
8626|NCT02085720|Secondary|AHI Result||1 year|||% of participants|||Number
8627|NCT02085720|Secondary|CPAP Compliance Among Chinese Elderly|Elderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).|1 year|||hours||Standard Deviation|Mean
8628|NCT02085720|Secondary|Prevalence of Restless Leg Syndrome (RLS)|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.|3 years|||% of participants|||Number
8629|NCT02085720|Primary|Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly|Subjects who have completed the questionnaires and consented for sleep study are invited to undergo a portable at-home sleep study (EMBLETTA). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea hypopnea index (AHI) based on recording time. AHI is the average number of events per hour while 5-15 events per hour denotes mild OSA, 16-30 events moderate OSA, and >30 events severe OSA. Obstructive sleep apnea syndrome is defined as AHI 15 events or above or AHI being 5 or above pulus ESS 10 or more. This measure is reporting the percentage of participants with OSAS.|3 years|||% of participants|||Number
8630|NCT02085161|Secondary|Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment|Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Liter||Standard Error|Least Squares Mean
8631|NCT02085161|Secondary|One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment|One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Liter||Standard Error|Least Squares Mean
8632|NCT02085161|Secondary|One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment|One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Liter||Standard Error|Least Squares Mean
8633|NCT02085161|Secondary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Second||Standard Error|Geometric Mean
9452|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 13|Participants with usable data included in the results||pg/mL||Standard Deviation|Mean
8634|NCT02085161|Secondary|Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12|Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don’t do because of health reasons - 0, and don’t do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Units on a scale||Standard Error|Least Squares Mean
8635|NCT02085161|Secondary|Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment|Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Multiple of 9.8*(meters / (second^2))||Standard Error|Least Squares Mean
8636|NCT02085161|Secondary|Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12|Average daily walking time measured by the activity monitor in the week prior to Week 12.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Second||Standard Error|Least Squares Mean
8637|NCT02085161|Primary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 8|Full analysis set (FAS): This patient set included all patients in the Treated set (TS) who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.||Second||Standard Error|Geometric Mean
8638|NCT02084797|Other Pre-specified|Fluid Intake|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)||||||
8639|NCT02084797|Other Pre-specified|Performance|To determine if exercise performance, as determined by overall exercise time, was affected in response to the V2R antagonist, agonist and placebo conditions.|4 trials (4 weeks)||||||
8640|NCT02084797|Other Pre-specified|Sodium Palatability Ratings|To determine if sodium preference ratings were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)||||||
8641|NCT02084797|Other Pre-specified|Thirst Rating|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 trials (4 weeks)||||||
8642|NCT02084797|Other Pre-specified|Core Temperature|Measurement of core temperature using an ingestible CorTemp sensor during the V2R antagonist, agonist and placebo trials will allow researchers to assess if fluid homeostasis and thermoregulation were intertwined in response to each pharmacological intervention.|4 trials (4 weeks)||||||
8643|NCT02084797|Other Pre-specified|Body Weight|Changes in body weight during the V2R antagonist, agonist and placebo conditions will provide researchers with an additional measure of overall fluid balance (fluid in versus fluid out) as well as an estimate of overall sweat water losses.|4 trials (4 weeks)||||||
8644|NCT02084797|Secondary|Saliva Sodium Concentration|Measurement of salivary sodium concentration will allow us to determine if the V2R antagonist, agonist and placebo interventions activate aquaporin-5 (AQP5) water channels that are also located in sweat glands. If the V2R acts on the sweat glands through AQP5, there should be parallel changes in sweat, urine and saliva sodium concentrations with each pharmaceutical intervention.|4 trials (4 weeks)|||mEq/L||Standard Deviation|Mean
8645|NCT02084797|Secondary|Blood Sodium Concentration|Measurement of blood sodium concentration will determine if normonatremia (blood sodium concentrations within the normal physiological range of 135-145mmol/L) were maintained throughout the trial with appropriate fluid intake during the V2R antagonist, agonist and placebo intervention trials.|4 study trials (4 weeks)|||mEq/L||Standard Deviation|Mean
8646|NCT02084797|Secondary|Urine Sodium Concentration After the Steady-state Portion of the Trial|Changes in urine sodium concentration after use of the V2R antagonist, agonist and placebo interventions will verify whether or not pharmacologic activation or inhibition was successfully induced.|4 study trials (4 weeks)|||mEq/L||Standard Deviation|Mean
9631|NCT02041520|Secondary|Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM/ml||Standard Deviation|Mean
8647|NCT02084797|Primary|Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial|Changes in sweat sodium concentration will parallel changes in urine sodium concentration with use of the V2R antagonist, agonist and placebo if the primary hypothesis is true (sweat sodium is regulated by the V2R, similar to how urine sodium is regulated by principle cells located within in the kidney collecting duct)|4 study trials (4 weeks)|||mEq/L||Standard Deviation|Mean
8648|NCT02084706|Primary|Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection|Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced.|Our outcome measure was collected within the 60 seconds before and following the steroid injection.|||units on a scale||Standard Deviation|Mean
8649|NCT02084628|Secondary|Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question|Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).|Images were taken pre-injection and post-injection (within about 15 minutes)|||number of responses|||Number
8650|NCT02084628|Secondary|Change in Diagnosis for the Combined Images Compared With Precontrast Images|Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.|Images were taken pre-injection and post-injection (within about 15 minutes)|||participants|||Number
8651|NCT02084628|Secondary|Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)|||participants|||Number
8652|NCT02084628|Secondary|Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question|"Biliary system included~Gall bladder~Cystic duct~Common bile duct~Right main bile duct~Left main bile duct"|Images were taken pre-injection and post-injection (within about 15 minutes)|||number of responses|||Number
8653|NCT02084628|Secondary|Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)|||number of responses|||Number
8654|NCT02084628|Secondary|Number of Lesions Detected for the Combined Images||Images were taken pre-injection and post-injection (within about 15 minutes)|||number of lesions|||Number
8655|NCT02084628|Secondary|Number of Lesions Detected for the Pre-contrast Images||Images were taken pre-injection|||number of lesions|||Number
8656|NCT02084628|Primary|Number of Subjects With Serious Adverse Events|An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|From the signing of the informed consent form until the 6 month post MRI follow-up|||participants|||Number
8657|NCT02084628|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.|From the signing of the informed consent form until the 6 month post MRI follow-up|||participants|||Number
8658|NCT02084628|Primary|Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images|Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.|Images were taken pre-injection and post-injection (within about 15 minutes)|||participants|||Number
8659|NCT02084238|Secondary|Safety Assessment|Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.|up to Day 180||11/2015||||
8660|NCT02084238|Secondary|Number of Relapses|Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months.|24 weeks||11/2015||||
8661|NCT02084238|Secondary|SELENA SLEDAI Score|"Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points, score> 8 means the disease is moderate-to-severe active."|week 0, week 10|||score||Standard Deviation|Median
8662|NCT02084238|Secondary|The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients|Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.|week 0 and week 10|||g/L||Full Range|Median
8663|NCT02084238|Secondary|Immunological Responses|Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study.|week 0 and week 10|regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells||Percentage of CD4+ T cells||Full Range|Median
8664|NCT02084238|Primary|Number of Participants Who Were SLE Responders (SRI)|SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.|week 2，week 4，week 6，week 8，week 10|||paticipants|||Number
8674|NCT02084056|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8665|NCT02084082|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
8666|NCT02084082|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
8667|NCT02084082|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8668|NCT02084082|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
8669|NCT02084082|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
8670|NCT02084082|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
8671|NCT02084069|Primary|Atrial Fibrillation Incidence After Open Cardiac Valve Repair||Within 5 days after open cardiac valve repair|||participants|||Number
8672|NCT02084056|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 2000 fast and PKS 2000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8673|NCT02084056|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
8709|NCT02083406|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation||ng/mL||Geometric Coefficient of Variation|Geometric Mean
19164|NCT01789775|Secondary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.|D1||||||
8675|NCT02084056|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8676|NCT02084056|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
8677|NCT02084056|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
8678|NCT02083965|Secondary|Development of Inhibitor as Measured by the Nijmegen-Modified Bethesda Assay|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the proportion of subjects with a confirmed inhibitor was calculated using the Clopper-Pearson method for a binomial proportion.|up to Month 6 (26 ± 2 weeks) or Early Withdrawal|The Safety Analysis Set included participants who received at least 1 dose of rFVIIIFc.||percentage of participants||95% Confidence Interval|Number
8679|NCT02083965|Secondary|Vz as Measured by Two-Stage Chromogenic Clotting Assay|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
8680|NCT02083965|Secondary|DNAUC as Measured by Two-Stage Chromogenic Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
8681|NCT02083965|Secondary|AUCext as Measured by Two-Stage Chromogenic Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
8682|NCT02083965|Secondary|Lambda Z as Measured by Two-Stage Chromogenic Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z).|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||1/h||95% Confidence Interval|Geometric Mean
8683|NCT02083965|Secondary|AUClast as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
8684|NCT02083965|Secondary|Tmax as Measured by Two-Stage Chromogenic Clotting Assay|Time at which maximum activity (Cmax) is observed.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
8685|NCT02083965|Secondary|MRT as Measured by Two-Stage Chromogenic Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
8710|NCT02083406|Primary|OZ439 AUC(0-168h)|OZ439 Area under the plasma concentration (AUC) versus time curve|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for pharmacokinetics (PK) parameter estimation||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8686|NCT02083965|Secondary|Vss as Measured by Two-Stage Chromogenic Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
8687|NCT02083965|Secondary|CL as Measured by Two-Stage Chromogenic Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/h/kg||95% Confidence Interval|Geometric Mean
8688|NCT02083965|Secondary|t½ as Measured by Two-Stage Chromogenic Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
8689|NCT02083965|Secondary|Cmax as Measured by Two-Stage Chromogenic Clotting Assay|Maximum measured concentration of rFVIIIFc.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL||95% Confidence Interval|Geometric Mean
8690|NCT02083965|Secondary|IR, K Value as Measured by Two-Stage Chromogenic Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
8691|NCT02083965|Secondary|AUCinf as Estimated From the FVIII Activity Data as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
8692|NCT02083965|Secondary|Terminal Exponential Volume of Distribution (Vz) as Measured by aPTT|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
8693|NCT02083965|Secondary|Dose Normalized Area Under the Curve (DNAUC) as Measured by aPTT Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
8694|NCT02083965|Secondary|Percentage of AUCinf From the Last Data Point to Infinity (AUCext) as Measured by aPTT Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
8695|NCT02083965|Secondary|Terminal Exponential Rate Constant (Lambda Z) as Measured by aPTT Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z) .|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||1/h||95% Confidence Interval|Geometric Mean
8696|NCT02083965|Secondary|Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
8697|NCT02083965|Secondary|Time of Cmax (Tmax) as Measured by aPTT Clotting Assay|Time at which maximum activity (Cmax) is observed.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
8711|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>=0.5 to <= 2 Years)|Artefenomel concentration on Day 7 in African Patients >= 0.5 to <=2 years. All Treatment arms.|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
27686|NCT01643525|Secondary|Determine the Location to Left, Right, Deep, and/or Back of the Cranium||At study completion- approximately 8 months||||||
8698|NCT02083965|Secondary|Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
8699|NCT02083965|Secondary|Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/kg||95% Confidence Interval|Geometric Mean
8700|NCT02083965|Secondary|Clearance (CL) as Measured by the aPTT Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||mL/h/kg||95% Confidence Interval|Geometric Mean
8701|NCT02083965|Secondary|Half-life (t½) as Measured by aPTT Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||hours||95% Confidence Interval|Geometric Mean
8702|NCT02083965|Secondary|Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay|Maximum measured concentration of rFVIIIFc.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL||95% Confidence Interval|Geometric Mean
8703|NCT02083965|Primary|Incremental Recovery (IR, K Value) as Estimated From the FVIII Activity Data Measured by aPTT Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU/dL||95% Confidence Interval|Geometric Mean
8704|NCT02083965|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by Activated Partial Thromboplastin Time (aPTT) Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Up to 96 hours (±60 minutes) after each of 2 injections|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.||IU*h/dL||95% Confidence Interval|Geometric Mean
8705|NCT02083679|Secondary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the first trial treatment given (Sym004 or one of the individual Platinum-Doublet therapies) or if they worsened after receiving first dose of treatment.|Day 1 up to 28 days after last dose of study drug (up to 53 weeks)|The safety analysis set included all 15 subjects who were administered any dose of the trial medication.||subjects|||Number
8706|NCT02083679|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not >5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not >5 days; fatigue/headache lasting < 7 days; nausea/vomiting/diarrhoea lasting not >3 days; asymptomatic Grade 3 increase in liver function tests that resolve to baseline within 7 days; Mucositis >= Grade 3 lasting < 7 days; Grade 3 hyperglycemia that resolves in < 7 days; any laboratory values >Grade 3 without any clinical correlate (resolve within 5 days); Grade 3 skin toxicities that resolve to Grade 2 within 7 days; Grade 3/4 hypomagnesemia that resolves within 5 days. Subjects with DLTs presented based on investigator and SMC decision.|Day 1 to Day 21 of Cycle 1|The dose limiting toxicity set included all 15 subjects in the safety analysis set (SAF) who received all planned trial medication doses during the first 21 days following the first dose of Sym004.||Subjects|||Number
8707|NCT02083406|Secondary|PQ Cmax|PQ Maximum observed concentration|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8708|NCT02083406|Secondary|Piperaquine (PQ) AUC(0-168h)|PQ Area under the plasma concentration versus time curve|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8719|NCT02083380|Secondary|PRR48|Parasite reduction ratio at 48 hours post dose|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. Subjects with sufficient data points to determine PRR48||ratio||Inter-Quartile Range|Median
8720|NCT02083380|Secondary|Fever Clearance Time|Time to fever clearance (hours)|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||hours||95% Confidence Interval|Median
8721|NCT02083380|Secondary|Parasite Clearance Time|Time post dose to parasite clearance|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||hours||95% Confidence Interval|Median
8722|NCT02083380|Secondary|Kaplan-Meier Estimate of New Infection Rate|Kaplan-Meier estimate of number of patients with new infections|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% population with new infection|||Number
8723|NCT02083380|Secondary|Kaplan-Meier Estimate of Recrudescence|Kaplan-Meier estimate of number of patients with recrudescence|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% patients with recrudescence|||Number
8724|NCT02083380|Secondary|Kaplan-Meier Estimate of Recurrence|Kaplan-Meier estimate of number of recurrent infections (either recrudescence or new infection)|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% population recurring|||Number
8725|NCT02083380|Secondary|Crude ACPR at Day 63 in the ITT Population|Crude adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
8726|NCT02083380|Secondary|Crude ACPR at Day 42 in the ITT Population|Crude adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
8727|NCT02083380|Secondary|Crude ACPR at Day 28 in the ITT Population|Crude adequate clinical and parasitological response at Day 28 in the ITT population|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
8728|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8729|NCT02083380|Secondary|PCR-adjusted ACPR at Day 42 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8730|NCT02083380|Secondary|PCR-adjusted ACPR at Day 28 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 28. Intent to Treat ( ITT) population.|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8731|NCT02083380|Secondary|Crude ACPR at Day 63 in the PP Population|Crude adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
8732|NCT02083380|Secondary|Crude ACPR at Day 42 in the PP Population|Crude adequate clinical and parasitological response at Day 42|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR unajusted (crude)||95% Confidence Interval|Number
8733|NCT02083380|Secondary|Crude ACPR at Day 28 in the PP Population|Crude adequate clinical and parasitological response at Day 28|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.||% ACPR unadjusted (crude)||95% Confidence Interval|Number
8744|NCT02083263|Primary|Lung Function: Lung Clearance Index|Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.|up to 3 months|||lung clearance index||Standard Deviation|Mean
8734|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the PP Population|PCR-adjusted adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8735|NCT02083380|Secondary|PCR - Adjusted ACPR at Day 42 in the PP Population|PCR - adjusted adequate clinical and parasitological response at Day 42|Days 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8736|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8737|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8738|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8739|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8740|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8741|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8742|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population (All Patients)|"Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP).~95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.||% ACPR PCR-adjusted||95% Confidence Interval|Number
8751|NCT02083107|Secondary|APGAR Score|The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).|1minute and 5 minutes from delivery of the fetus|||units on a scale||Standard Deviation|Mean
8752|NCT02083107|Other Pre-specified|Change in Hemoglobin Concentration||24 hours postoperative from baseline hemoglobin|||gram/dL||Standard Deviation|Mean
8753|NCT02083107|Secondary|Need for Extra Ecbolics (Oxytocin).||from start of cesarean section till the end of operation (average one hour)|||participants|||Number
8754|NCT02083107|Primary|Intraoperative Blood Loss||from start of cesarean section till the end of operation (average one hour)|||millilitres||Standard Deviation|Mean
8755|NCT02082912|Secondary|Change in Functional Motor Task Performance||Baseline and at end of 3 weeks of treatment||||||
8756|NCT02082912|Secondary|Change in Memory and Information Processing Speed||Baseline and at end of 3 weeks of treatment||||||
8757|NCT02082912|Secondary|Change in Depressive Symptoms||Baseline and at end of 3 weeks of treatment||||||
8758|NCT02082912|Secondary|Change in Stroke Impact Scale Score||Baseline and at end of 3 weeks of treatment||||||
8759|NCT02082912|Primary|Mean Change in Grip Strength of Affected Hand|Hand-grip strength was assessed using the whole hand and defined as the average of 3 trials using a calibrated Jamar dynamometer (Jamar Dynamometer, Asimow Engineering Co., Santa Monica, CA), with the elbow flexed to 90º and the forearm in a neutral position. This is the standardized method for measuring hand-grip strength with a Jamar dynamometer recommended by the American Society of Hand Therapists. Change was calculated by subtracting baseline from outcome at week 3.|Baseline, 3 weeks (end of treatment)|||Newton||Standard Deviation|Mean
8760|NCT02082769|Other Pre-specified|Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline||Baseline and Final Visit (up to 26 weeks)|||umol/l||Standard Deviation|Mean
8761|NCT02082769|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit||Final Visit (up to 26 weeks)|||percentage of participants|||Number
8762|NCT02082769|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)||Last 3 visits (any last 3 visits up to week 26)|||percentage of participants|||Number
8763|NCT02082288|Primary|Clinical Pregnancy|A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.|6 weeks|||participants|||Number
8764|NCT02082262|Primary|Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale|Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Day 70|Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score||Scores on a Scale||Standard Deviation|Mean
8765|NCT02082158|Secondary|To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs|Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.||units on a scale||Standard Deviation|Mean
8766|NCT02082158|Primary|To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs|Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.||units on a scale||Standard Deviation|Mean
8767|NCT02081599|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg/dL||Standard Error|Least Squares Mean
8778|NCT02081183|Primary|Creatinine Clearance|Creatinine clearance in an indicator of kidney function. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult values are 97 to 137 milliliters per minute (mL/min) for males and 88 to 128 mL/min for females.|18 months|Data were not analyzed because the study was terminated early.|||||
8768|NCT02081599|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*hr/dL||Standard Error|Least Squares Mean
8769|NCT02081599|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.||mg/dL||Standard Error|Least Squares Mean
8770|NCT02081599|Primary|Change From Baseline in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.||percentage of HbA1c||Standard Error|Least Squares Mean
8771|NCT02081365|Secondary|Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment|||units on a scale||Standard Error|Mean
8772|NCT02081365|Secondary|Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment|||units on a scale||Standard Error|Mean
8773|NCT02081365|Secondary|Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before dental appointment to one-month after dental appointment|||units on a scale||Standard Error|Mean
8774|NCT02081365|Primary|Change in Modified Dental Anxiety Scale|The Modified Dental Anxiety Scale a five-item self-report measure that assesses fear of dental procedures, including drilling, scaling and polishing (i.e., cleaning), and local anesthetic injections. Sample items include, “If you went to your dentist for treatment tomorrow, how would you feel?” and “If you were about to have your tooth drilled, how would you feel?” Items are rated on a five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored > 19 on the MDAS at baseline or endorsed at least two MDAS items > 4 to have high dental anxiety.|Change from one week before dentist appointment to 1 month after dentist appointment|||units on a scale||Standard Error|Mean
8775|NCT02081183|Primary|Serum Albumin|Albumin is a protein made by the liver. A serum albumin test measures the amount of this protein in the clear liquid portion of the blood. Decreased serum albumin levels can be an indicator of liver and/or kidney disease, The normal range is 3.4 - 5.4 grams (g)/dL.|18 months|Data were not analyzed because the study was terminated early.|||||
8776|NCT02081183|Primary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly participants typically have smaller muscle mass.|18 months|Data were not analyzed because the study was terminated early.|||||
8777|NCT02081183|Primary|Urinary Protein|Protein in urine is an indicator of kidney function. An increased urinary protein level indicates decreased kidney function. Normal values are approximately 0 to 8 milligrams per deciliter (mg/dL).|18 months|Data were not analyzed because the study was terminated early.|||||
8780|NCT02081079|Secondary|Percentage of Patients With Virologic Failure|"Virologic failure was defined as either:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or~Relapse:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment"|Up to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
8781|NCT02081079|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
8782|NCT02081079|Primary|Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
8783|NCT02081079|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 or 5 HCV infection who were enrolled and received at least on dose of study drug.||percentage of participants|||Number
8784|NCT02081014|Secondary|Glucose Tmax (Post-insulin)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
8785|NCT02081014|Secondary|Glucose Tmax (Fasting)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
8786|NCT02081014|Secondary|Glucose AUC (Post-insulin)|Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(mg/dl)*minutes||Standard Error|Mean
8787|NCT02081014|Secondary|Glucose AUC (Fasting)|Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(mg/dl)*minutes||Standard Error|Mean
8788|NCT02081014|Secondary|Glucose Cmax (Post-insulin)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||mg/dl||Standard Error|Mean
8789|NCT02081014|Secondary|Glucose Cmax (Fasting)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||mg/dl||Standard Error|Mean
8790|NCT02081014|Secondary|Glucagon Tmax (Post-insulin)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
8791|NCT02081014|Secondary|Glucagon Tmax (Fasting)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||minutes||Standard Error|Mean
8792|NCT02081014|Secondary|Glucagon AUC (Post-insulin)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(pg/ml)*hour||Standard Error|Mean
8793|NCT02081014|Secondary|Glucagon Area Under the Curve (AUC) (Fasting)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug||(pg/ml)*hour||Standard Error|Mean
8794|NCT02081014|Secondary|Glucagon Cmax (Post-insulin)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subject who received at least one dose of study drug||pg/ml||Standard Error|Mean
8795|NCT02081014|Secondary|Glucagon Cmax (Fasting)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug||pg/ml||Standard Error|Mean
8796|NCT02081014|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment|From first dose until follow-up call, up to 7 weeks per subject|All randomized subjects who received at least one dose of study drug||participants|||Number
8797|NCT02081001|Secondary|Infusion Site Discomfort Score at 30 Minutes|Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 30 minutes post-dosing|All treated subjects||mm||Standard Deviation|Mean
8798|NCT02081001|Secondary|Infusion Site Discomfort Score at 10 Minutes|Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 10 minutes post-dosing|All treated subjects||mm||Standard Deviation|Mean
8800|NCT02081001|Secondary|Glucagon AUC|Area under the plasma concentration time curve for glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||(pg/dl)*minutes||Standard Deviation|Mean
8801|NCT02081001|Secondary|Glucose Tmax|Time to maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.||minutes||Standard Deviation|Mean
8802|NCT02081001|Secondary|Glucagon Tmax|Time to maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||minutes||Standard Deviation|Mean
8803|NCT02081001|Secondary|Glucose Cmax|Maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||mg/dl||Standard Deviation|Mean
8804|NCT02081001|Secondary|Glucagon Cmax|Maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||pg/dl||Standard Deviation|Mean
8805|NCT02081001|Primary|Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)|The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.||minutes||Standard Deviation|Mean
8806|NCT02081001|Primary|Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)|The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.||minutes||Standard Deviation|Mean
8807|NCT02080780|Primary|Peak Plasma Concentration (Cmax) of 2% Diltiazem|To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.|9 days|||ng / mL||Standard Deviation|Mean
8808|NCT02080546|Secondary|Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing|a difference between arms in the proportion of patients who have at least one of the following post-operatively: vaginal vault granulation tissue, vaginal cuff separation/dehiscence, or vaginal apex infection|4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination|This secondary objective was not evaluated||participants||95% Confidence Interval|Number
8809|NCT02080546|Primary|Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy|"distance in millimeters over which thermal tissue injury extends (henceforth referred to as injury)."|up to 36 months|49 participants were included in the cut/coag arm and 52 participants in the V mode arm. Thermal injury was assessed at the anterior margin in 91 specimens and at the posterior margin in 93 specimens.||mm|Participants|Full Range|Mean
8810|NCT02080312|Secondary|Extension of Contrast From Perilymph to CSF|The fundus of the internal auditory canal (IAC) was visually inspected to determine if there was conspicuous, subtle, or no enhancement extending in the setting of prior IT contrast injection, indicating permeability of the cochlear modiolus.|24 hours post injection|||participants|||Number
8811|NCT02080312|Primary|"Cochlear Endolymphatic Hydrops (EH)"|The relative volume of the scala media of the basal turn of the cochlea (non-enhancing endolymph) was visually assessed relative to the scala tympani and scala vestibuli (enhancing perilymph) on delayed post-IT contrast FLAIR MRI sequences. Cases were characterized as: No Cochlear EH (no perceptible distention of the scala media), Cochlear EH (perceptible distention of the scala media), or Absent enhancement (no contrast in the cochlear perilymph)|24 hours post injection|||participants|||Number
8812|NCT02080312|Primary|"Vestibular Endolymphatic Hydrops (EH)"|The relative volume of the non-enhancing endolymphatic space was visually assessed relative to the enhancing perilymphatic space on delayed post-IT contrast FLAIR MRI sequences and characterized as <34%, 34-50% or >50% of endolymphatic/perilymphatic volume.|24 hours post injection|||participants|||Number
8813|NCT02080091|Secondary|Retinal Center Subfield Thickness|Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.|24 months|23 Patients received ILUVIEN, one patient was treated bilaterally||microns|Participants|Standard Deviation|Mean
8814|NCT02080091|Primary|Number of Patients With Ocular Adverse Events||24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally||participants|Participants||Number
8815|NCT02080091|Primary|Visual Acuity|Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.|24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally||LogMAR|Participants|Standard Error|Mean
8816|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurement|Vital signs were oral body temperature, respiration rate, supine blood pressure (after 5 minutes resting), and pulse rate.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the vital sign tests on Day 8 of each treatment period.||percentage of participants|||Number
8817|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests|Percentage of participants with markedly abnormal safety laboratory tests (Hematology, Serum Chemistry and Urinalysis) collected throughout the study.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the laboratory tests during treatment.||percentage of participants|||Number
8903|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8818|NCT02079844|Secondary|Percentage of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 until Day 63|Safety population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
8819|NCT02079844|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Positive subscale consists of 7 items which assesses the positive symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. General psychopathology subscale consists of 16 items which assesses the general symptoms of schizophrenia with subscale score ranging from 16 to 96, where higher score indicates greater severity. A negative change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||score on a scale||Standard Error|Least Squares Mean
8820|NCT02079844|Secondary|Change From Baseline in Frontal Theta Power (EEG) During N-Back Working Memory Task|EEG, a test that measures brain electrical activity, was performed during the n-back task. In the n-back task participants are required to monitor a series of letters and report when the current letter matches the letter n integers back, where n=1 (1-back) or n=2 (2-back), the latter requiring a greater working memory resources. The task requires continuous updating of information stores. In the 0-back condition (which does not require manipulation of material in working memory), participants respond to the appearance of a pre-specified letter. The task consists of alternating 30-second (s) blocks of 0-back with 1-back, and 2-back conditions, with letters displayed every 2 s for 1 s within each block. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||μV||Standard Error|Least Squares Mean
8821|NCT02079844|Secondary|Change From Baseline in High Beta/Low Gamma Power During Resting EEG|Participants are asked to open and close their eyes in 30 second alternating blocks to maintain an approximately constant level of arousal. The eyes closed EEG, a test that measures brain electrical activity, is dominated by alpha (8-14Hz) and the eyes open EEG dominated by beta (14-30Hz eyes open) with the two states analyzed separately to increase sensitivity to drug effects in these bands. Ratio is calculated as High Beta/Low Gamma Power. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||ratio||Standard Error|Least Squares Mean
8822|NCT02079844|Secondary|Change From Baseline in Amplitude of the C1 Component of the Visual Evoked Potentials at the Midline Occipital Electrode (Oz)|EEG, a test that measures brain electrical activity was used. Participants had a baseline Visual Evoked Potentials (VEP) recording (2 minute checkerboard VEP) followed by a period of high frequency stimulation (2 minutes 9 Hz checkerboard stimulation). The VEP was repeated 2 minutes after the end of high frequency stimulation. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||μV||Standard Error|Least Squares Mean
8823|NCT02079844|Secondary|Change From Baseline in Mismatch Negativity (MMN) Amplitude at the Midline Frontal Electrode (Fz)|EEG, a test that measures brain electrical activity was performed during the MMN. The MMN is an auditory event related potential that is elicited by any discriminable change in auditory stimulation irrespective of the participant or participant's attention. The response to stimuli is being recorded by EEG electrodes while participants read a book. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||μV||Standard Error|Least Squares Mean
8824|NCT02079844|Secondary|Change From Baseline in P300 Amplitude at the Midline Parietal Electrode (Pz)|"Brain electrical activity changes were quantified with electroencephalogram (EEG) battery tests. The P300 occurs after the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli. It reflects allocation of attention and activation of immediate memory.~The amplitude of P300 indexes brain actions when the mental representation of the stimulus environment is updated, while its latency indexes stimulus classification speed unrelated to response selection processes. The participants are instructed to push a button when hearing the target stimulus, but not when hearing the standard. They are asked to press the button as fast as possible. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.||microvolts (μV)||Standard Error|Least Squares Mean
8825|NCT02079844|Secondary|Ventral Striatum Activation During the Reward Trials|"BOLD fMRI, a test that measures brain activity, was used during the Reward Task (Monetary Incentive Delay Test). Participants were instructed to respond as quickly as possible to a light-flash on the display screen. The flash was preceded by an arrow icon that informed participants about the consequences of their response to the flash stimulus. Four conditions were included in the paradigm, as follows:~Win condition (arrow up): win 2 pound sterling if the response was sufficiently fast.~Avoidance of loss condition (arrow down: lose 2 pound sterling if the response was too slow.~Verbal control (vertical double arrow): no gain or loss of money.~Passive control condition (horizontal double arrow): No response was required. Each of the above conditions was presented at least 10 times in a random order. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||unitless parameter estimates||Standard Error|Least Squares Mean
8826|NCT02079844|Secondary|Ventrolateral Prefrontal (VLPF) Cortex and Orbitofrontal (OFX) Cortex Activation During the Shift Trials|BOLD fMRI, a test that measures brain activity, was used during the Shifting Task at VLPF and OFX. Participants worked out which pair in a stimulus set consisting of a face and a building; transparent and overlapping, was the target. 1 pair appeared on the left of the screen, the other on the right. In each trial, participants indicated using a button box which side of the screen they thought the target was located on. Every second response, feedback was presented on the screen for 0.6 seconds, indicating whether or not the stimulus chosen was the target. If both of the last 2 choices were correct, the feedback was the word ‘‘correct’’ in green; otherwise, the feedback was the word ‘‘incorrect’’ in red. After 3 positive feedback events, a change of target occurred. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||unitless parameter estimates||Standard Error|Least Squares Mean
8827|NCT02079844|Secondary|Change From Baseline in Category Fluency Animal Naming Scores|The Category Fluency test assesses the participant's speed of processing. The test is administered orally, with the participant naming as many animals as he can in 1 minute. The key outcome variable for the test is the total number of correct, valid category words in 60 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||correct words||Standard Error|Least Squares Mean
8828|NCT02079844|Secondary|Change From Baseline in Brief Assessment of Cognition in Schizophrenia: Symbol-Coding|The Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding assesses the participant's speed of processing. The test is a timed paper-and-pencil test in which the participant uses a key to write digits that correspond to nonsense symbols. The key outcome variable for this task is the total number of correct, valid symbols in 90 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||correct symbols||Standard Error|Least Squares Mean
8829|NCT02079844|Secondary|Change From Baseline in the Continuous Performance Test (CPT)|The CPT is a computerized test that assesses the participant’s attention and vigilance. The participant was asked to attend to digits flashing on a computer screen and to click the mouse when the same string of digits flashed consecutively. The test consisted of 3 trials: the first contained 2-digit sequences, the second contained 3-digit sequences, and the third contained 4-digit sequences. Scoring was based the number of correct hits. The total score was an average of the 3 trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||correct hits||Standard Error|Least Squares Mean
8830|NCT02079844|Primary|Dorsolateral Prefrontal Cortex Activation During the Rewarded Delayed Response Working Memory|BOLD Functional magnetic resonance imaging (fMRI) changes in the blood-oxygen-level-dependent (BOLD) - signal, which changes in response to neural activity. Baseline fMRI measurements will be followed by rewarded delayed response Working Memory (WM) task measurements in which participants are required to remember the spatial location of a target stimulus (a dot) relative to a fixation cross. Participants are given feedback indicating success or failure. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.||unitless parameter estimates||Standard Error|Least Squares Mean
8831|NCT02079844|Primary|Change From Baseline in Hopkins Verbal Learning Test (HVLT) Score|The HVLT assesses the participant's verbal learning. The test consists of a list of 12 words from three taxonomic categories which are presented orally, and the participant is asked to recall as many as possible after each of three learning trials. The key outcome variable for this task is the total correct responses in the three learning trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.||correct responses||Standard Error|Least Squares Mean
8832|NCT02079844|Primary|Change From Baseline in Spatial Span Test Score|The Spatial Span test assesses the participant’s working memory. During this task, participants are presented with a board containing blue blocks randomly arranged. The rater first taps out a pattern of blocks, beginning with two blocks and increasing with participant proficiency, and the participant is tasked with tapping the same pattern. After discontinuation of this part of the subtest, the participant is then tasked with tapping out the reverse pattern after the rater's demonstration. These patterns also begin with two blocks and increase with participant proficiency. The total score for this subtest ranges from 0 (worst) to 32 (best). A positive change from Baseline indicates improvement. Analysis of Variance (ANOVA) with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.||score on a scale||Standard Error|Least Squares Mean
8833|NCT02079649|Secondary|Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline].|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.||hours x units on a scale||Standard Error|Mean
8834|NCT02079649|Primary|Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline]. Both eyes contributed to the analysis.|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.||hours x units on a scale||Standard Error|Mean
8835|NCT02079532|Secondary|Rheumatoid Factor (RF)|Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||IU/mL||Standard Deviation|Mean
8836|NCT02079532|Secondary|Erythrocyte Sedimentation Rate (ESR)|Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm/hr||Standard Deviation|Mean
8837|NCT02079532|Secondary|C-Reactive Protein (CRP)|Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mg/dL||Standard Deviation|Mean
8838|NCT02079532|Secondary|Patient's Assessment of Pain|Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no pain” and the right-hand (100 mm) as “unbearable pain”.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm||Standard Deviation|Mean
8839|NCT02079532|Secondary|Patient's Assessment of Disease Activity|Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as “maximum disease activity” (maximum arthritis disease activity).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm||Standard Deviation|Mean
8840|NCT02079532|Secondary|Physician's Global Assessment of Disease Activity|Physicians assessed the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as “maximum disease activity” (maximum arthritis disease activity).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||mm||Standard Deviation|Mean
8841|NCT02079532|Secondary|Tender Joint Count (TJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||tender joints||Standard Deviation|Mean
8842|NCT02079532|Secondary|Swollen Joint Count (SJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||swollen joints||Standard Deviation|Mean
8843|NCT02079532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit.|Weeks 8, 16, and 24|ITT population||percentage of participants|||Number
8904|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8844|NCT02079532|Secondary|SF-36 Domain Scores|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
8845|NCT02079532|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
8846|NCT02079532|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
8847|NCT02079532|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
8848|NCT02079532|Secondary|Percentage of Participants Achieving a Response By EULAR Category|Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score of >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Weeks 8, 16, and 24|ITT population||percentage of participants|||Number
8849|NCT02079532|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24|Percentage of participants with remission defined as DAS28 <2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population||percentage of participants|||Number
8850|NCT02079532|Secondary|Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24|Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).|Week 24|ITT population||percentage of participants|||Number
8851|NCT02079532|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate|The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of >1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1.|Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit||percentage of participants|||Number
8852|NCT02079532|Secondary|DAS28 Score|The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening and Weeks 8, 16, and 24|ITT population; n (number) = number of participants assessed at a given visit.||scores on a scale||Standard Deviation|Mean
8853|NCT02079532|Primary|Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient’s Global Assessment of Disease Activity (participant-ated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|Intent to Treat (ITT) population: all participants who signed informed consent, received at least 1 dose of study drug, and where DAS28 was measured at least once under study medication (Weeks 8, 16, or 24 or unscheduled or withdrawal visit up to Week 24); those with no RA or no DAS28 score at screening were excluded, regardless if treated or not.||scores on a scale||Standard Deviation|Mean
8856|NCT02079519|Primary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of the original monoclonal protein from the blood and urine on at least 2 determinations 6 weeks apart; < 5% plasma cells in the bone marrow on at least 2 determinations 6 weeks apart; if a skeletal survey is available, no increase in the size or number of lytic bone lesions; and the disappearance of soft tissue plasmacytomas for at least 6 weeks. A partial response was defined as a ≥ 50% reduction of monoclonal protein in the blood on at least 2 determinations 6 weeks apart; if present, reduction in 24-hour urinary light chain excretion by either ≥ 90% or to < 200 mg for at least 2 determinations 6 weeks apart; ≥ 50% reduction in the size of tissue plasmacytomas for at least 6 weeks; and if a skeletal survey is available, no increase in the size or number of lytic bone lesions.|Baseline to the end of the study (up to 1 year)|Intent-to-treat population: All participants who received at least 1 dose of study drug.||Percentage of participants|||Number
8857|NCT02079311|Primary|The Difference in Core Body Temperature in the Two Treatment Groups.|Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.|Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.|||degree celsius||Standard Deviation|Mean
8858|NCT02077374|Secondary|Levels of flCK18/M65|Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Full Range|Median
8859|NCT02077374|Secondary|Levels of Caspase 3/7 RLU|Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||RLU||Full Range|Median
8860|NCT02077374|Secondary|Levels of cCK18/M30|Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Full Range|Median
8861|NCT02077374|Secondary|Change in Aspartate Aminotransferase (AST)|Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo.|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Full Range|Median
8862|NCT02077374|Primary|Relative Percent Change in Alanine Aminotransferase (ALT)|Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Baseline to Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||Relative percent change||Standard Deviation|Mean
8863|NCT02077374|Primary|Change in Alanine Aminotransferase (ALT)|Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.||U/L||Standard Deviation|Mean
8864|NCT02076919|Secondary|Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.||mmHg||Standard Error|Least Squares Mean
8865|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.||mmHg||Standard Error|Least Squares Mean
8866|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.||mmHg||Standard Error|Least Squares Mean
8867|NCT02076919|Secondary|Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.||mmHg||Standard Error|Least Squares Mean
19283|NCT01787591|Primary|Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)||0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal|||umol/L x h||Standard Error|Mean
8868|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.||mmHg||Standard Error|Least Squares Mean
8869|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part 2|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.||participants|||Number
8870|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part I|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.||participants|||Number
8871|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.||mmHg||Standard Error|Least Squares Mean
8872|NCT02076919|Secondary|The Terminal Elimination Half-life [Time] (T1/2), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||hour||Standard Deviation|Mean
8873|NCT02076919|Secondary|The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||ng*h/mL||Standard Deviation|Mean
8874|NCT02076919|Secondary|The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||hour||Standard Deviation|Mean
8875|NCT02076919|Secondary|The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.||ng/mL||Standard Deviation|Mean
8876|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.||participants|||Number
8877|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.||participants|||Number
9453|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 7|Participants with usable data included in the results||pg/mL||Standard Deviation|Mean
8878|NCT02076009|Secondary|Duration of Response (DOR)|DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to the date of first documented evidence of PD until 3 years|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.||months||95% Confidence Interval|Median
8879|NCT02076009|Secondary|Time to Response|Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.|From randomization up to first documented CR or PR until 3 years|Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.||months||95% Confidence Interval|Median
8880|NCT02076009|Secondary|Overall Survival (OS)|Overall survival was measured from the date of randomization to the date of the participant's death.|Up to approximately 5 years (anticipated) after the last participant is randomized|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.||months||95% Confidence Interval|Median
8881|NCT02076009|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.||percentage of participants|||Number
8882|NCT02076009|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^- 4 threshold.|From randomization to the date of first documented evidence of PD until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.||percentage of participants|||Number
8883|NCT02076009|Secondary|Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better|VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
8884|NCT02076009|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From randomization to disease progression until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.||months||95% Confidence Interval|Median
8898|NCT02075125|Primary|Number of Participants With High Platelet Reactivity|Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
8885|NCT02076009|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to either disease progression or death whichever occurs first until 3 years|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.||months||95% Confidence Interval|Median
8886|NCT02075632|Secondary|Number of Days of Use|The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.|Day 1-Day 14|A subject was evaluable for summaries of number of days of use, if he or she used the study medication at least once and provided use information at Visit 2. Data for 4 subjects was not available for this analysis.||Days||Standard Deviation|Mean
8887|NCT02075632|Secondary|Number of Times Per Day Participants Used the Product|The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects.|Day1-Day14|A subject was evaluable for average number of applications per day and maximum number of applications per day if he or she used the study medication at least once and provided use information at Visit 2. Data for four subjects was not available for this analysis.||Applications||Standard Deviation|Mean
8888|NCT02075632|Primary|Number of Participants With Incorrect Duration of Use of the Medication|Incorrect duration of use was defined as the use of study medication for more than 7 consecutive days and/or more than three times in a day. Participants were asked the reasons of doing so and they were allowed to select multiple reasons also, if applicable.|Day1-Day 14|A participant was evaluable for analysis of the rate of incorrect use if he or she used the study medication at least once and provided use information at least 8 days after the enrollment visit.||Participants|||Number
8889|NCT02075411|Other Pre-specified|Failure of Nerve Block Procedures|We will determine the proportion of failure of the nerve block procedures as assessed by absence of a sensory block in the distribution of the femoral or sciatic nerves. The analysis will be of the numerical rating scale (NRS) scores immediately on arrival (baseline) in the recovery room and then every 6 hours over the first 72 hours post-op in the 2 groups.|72 hours post-operatively|Sample size was too small to conduct outcome analysis|||||
8890|NCT02075411|Secondary|Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group|Determine the duration of analgesia in the 2 groups. Analgesic duration will be the time interval between the end of the operation and the time of first administration of opioid for pain relief|72 hours post-operatively|Sample size was too small to conduct outcome analysis|||||
8891|NCT02075411|Primary|Opioid Pain Medication|total postoperative opioid pain medication used during the first 72 hours after the procedure|72 hours post-operatively|Sample size was too small to conduct outcome analysis|||||
8892|NCT02075125|Secondary|Pre-procedure Platelet Reactivity Index (PRI)|Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).||percentage||Inter-Quartile Range|Median
8893|NCT02075125|Secondary|Number of Participants With Low Platelet Reactivity|Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
8894|NCT02075125|Secondary|Pre-procedure P2Y12 Reaction Units (PRU)|Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).||PRU units||Inter-Quartile Range|Median
8895|NCT02075125|Secondary|Adverse Drug Reaction|Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number, compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
8896|NCT02075125|Secondary|Bleeding Event|Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
8897|NCT02075125|Secondary|Major Adverse Cardiac and Cerebrovascular Events|Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.||participants|||Number
8899|NCT02075073|Secondary|Time to Cmax (Tmax)||57 days|||hour||Standard Deviation|Mean
8900|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)||57 days|||µg·h/mL||Standard Deviation|Mean
8905|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8906|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8907|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8908|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life||Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8909|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8910|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8911|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8912|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8913|NCT02074995|Primary|Efficacy Measure by Change in Lean Body Mass (LBM)|Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.|Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided|||||
8914|NCT02074995|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with adverse events as a measure of safety and tolerability|Over 1 year|||Participants|||Number
8915|NCT02074709|Primary|Postoperative Pain Score on Coughing at 6 hr|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at 6 hr after surgery|||units on a scale||Standard Deviation|Mean
8916|NCT02074553|Secondary|Time to Reach Last Quantifiable Plasma Concentration (Tlast) of Alectinib and RO5468924|Tlast is the time from alectinib administration to reach last quantifiable concentration of alectinib and its major pharmacologically active metabolite RO5468924.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Full Range|Median
8917|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ratio||Standard Deviation|Geometric Mean
8918|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for AUC(0-last)|AUC(0-last) is the area under the plasma concentration versus time curve from time zero to the time of last measured concentration. AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-last) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ratio||Standard Deviation|Geometric Mean
8919|NCT02074553|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ratio||Standard Deviation|Geometric Mean
8920|NCT02074553|Secondary|Adjusted r^2 Value (Rsq) for Regression Estimation of Kel for Alectinib and RO5468924||Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||no units||Standard Deviation|Mean
8921|NCT02074553|Secondary|Percent Extrapolated AUC(0-inf) (AUC%Extrap[0-inf]) for Alectinib and RO5468924|The AUC%extrap(0-inf), that is, area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUC%extrap(0-inf) = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf); where AUC(0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time and AUC(0-last) is area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration. The function of this parameter is to provide information about what percentage of the theoretical curve AUC(0-inf) was possible to determine experimentally (AUC0-last).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||percent AUC||Standard Deviation|Mean
8922|NCT02074553|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||liters||Standard Deviation|Mean
20559|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
8923|NCT02074553|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||liters/hour||Standard Deviation|Mean
8924|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-last)|AUC(0-last) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib + RO5468924. AUC(0-last) is presented in nmol*hour/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||nmol*hour/L||Standard Deviation|Mean
8925|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||nmol/L||Standard Deviation|Mean
8926|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||nmol*hour/L||Standard Deviation|Mean
8927|NCT02074553|Secondary|Elimination Rate Constant (Kel) of Alectinib and RO5468924|First-order terminal elimination rate constant (Kel) was calculated as the negative slope of the linear regression of the terminal phase in plasma alectinib and RO5468924 concentration versus time profile using appropriate time points. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||1/hour||Standard Deviation|Mean
8928|NCT02074553|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Standard Deviation|Mean
8929|NCT02074553|Secondary|AUC(0-last) of RO5468924|AUC(0-last) is the area under the RO5468924 plasma concentration versus time curve from time zero to the time of last measured concentration of RO5468924. RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng*hour/mL||Standard Deviation|Mean
8930|NCT02074553|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng*hour/mL||Standard Deviation|Mean
8931|NCT02074553|Secondary|Tmax of RO5468924|Tmax is the time from alectinib administration to reach Cmax for RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Full Range|Median
8932|NCT02074553|Secondary|Cmax of RO5468924|Cmax is the maximum observed plasma RO5468924 concentration, presented in ng/mL. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng/mL||Standard Deviation|Mean
8933|NCT02074553|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib|Tmax is the time from alectinib administration to reach Cmax for alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||hours||Full Range|Median
8934|NCT02074553|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed plasma alectinib concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng/mL||Standard Deviation|Mean
8935|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib|AUC(0-last) is the area under the alectinib plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set||ng*hour/mL||Standard Deviation|Mean
8936|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|The Pharmacokinetic (PK) analysis set included all participants who received the reference formulation 50% SLS alectinib (Treatment A) and at least 1 test formulation (Treatments B, C, or D) and provided adequate PK assessments.||ng*hour/mL||Standard Deviation|Mean
8979|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24||Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||percentage of participants||95% Confidence Interval|Number
8937|NCT02074514|Secondary|Percentage of Participants With Virologic Failure and Viral Relapse|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
8938|NCT02074514|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
8939|NCT02074514|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
8940|NCT02074514|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
8941|NCT02074384|Primary|Portion of Study Participants Reporting Greater Utility From AGP vs. Traditional Glucose Data Reports|Patients will use either SMBG or CGM for a two week period following their screening visit. At the end of the two week period they will return to the study site to download their device and have an AGP report printed. They will then complete a preference and utility survey.|At the end of the two week SMBG or CGM period|||participants|||Number
8942|NCT02074358|Secondary|Mean Change From Baseline Temperature on Day 4 and Day 7|Temperature was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period and was measured in degrees centigrade (C). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had temperature data at baseline and post baseline were analyzed.||C||Standard Deviation|Mean
8943|NCT02074358|Secondary|Mean Change From Baseline in Respiration Rate on Day 4 and Day 7|Respiration Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Respiration Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in respirations (breaths) per minute. Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had respiration rate data at baseline and post baseline were analyzed.||breaths per minute||Standard Deviation|Mean
8944|NCT02074358|Secondary|Mean Change From Baseline in Heart Rate on Day 4 and Day 7|Heart Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Heart Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in beats per minute (bpm). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had heart rate data at baseline and post baseline were analyzed.||bpm||Standard Deviation|Mean
8945|NCT02074358|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7|Blood pressures were recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Blood pressure was measured after the participant had been seated quietly for at least 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had blood pressure data at baseline and post baseline were analyzed.||mmHg||Standard Deviation|Mean
8946|NCT02074358|Secondary|Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF|Single 12-lead ECGs were obtained at screening, Day -1 of Period 1, and Days 4 and 7 of each treatment period after the participant had been supine for at least 5 minutes. Pulse Rate (PR), Complex of Q, R, S waves (QRS), and contraction of ventricle between the beginning of the Q wave and end of the T wave (QT) were measured in milliseconds (msec). QT was corrected by the Fridericia method (QTcF) and measured in msec. Baseline was Day -1 of first treatment period. Crossover study: same participant with out of range ECG intervals could be reported in multiple arms.|Day -1 first treatment period, Days 4 and 7 each treatment period|Those participants who received any study medication and had available ECG data at baseline and Days 4 and 7 in each treatment period were analyzed.||participants|||Number
8947|NCT02074358|Secondary|Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population|Blood, urine samples obtained at screening, Days -1, 4, and 7 of each treatment period, and study discharge (Day 11 of Treatment Period 3). MA: Leukocyte White Blood Cells (WBC) *10^3 cells per microliter (c/µL); High (H): > 1.2*upper limits normal (ULN) if lower limits normal (LLN) <= pre-therapy (PreRx) <= ULN; > 1.2*ULN if PreRx = Missing; > 1.5*PreRx if PreRx > ULN; > ULN if PreRx < LLN. Alanine Aminotransferase (ALT) units per liter (U/L); H: > 1.25*PreRx if PreRx > ULN; > 1.25*ULN if PreRx <= ULN; > 1.25*ULN if PreRx = Missing. Total and Direct Bilirubin in milligrams/deciliter (mg/dL) H: > 1.1*ULN if PreRx <= ULN;> 1.1*ULN if PreRx = Missing; > 1.25*PreRx if PreRx > ULN. Blood in Urine H: >= 2*PreRx if PreRx >= 1; >= 2 if PreRx < 1; >= 2 if PreRx = Missing. Urine Red Blood Cells (RBC) and Urine WBC/ high powered field (hpf) H: >= 2 if PreRx = Missing; >= 2 if PreRx < 2; >= 4 if PreRx >= 2. Crossover study: same participant with MA could be reported in multiple arms.|Day 1 (first dose) to Day of Study Discharge (Day 11 of Treatment Period 3)|All participants who received any study medication and had available laboratory test data were analyzed. n=number of participants evaluated.||participants|||Number
8980|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||percentage of participants||95% Confidence Interval|Number
8948|NCT02074358|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Medical Dictionary for Regulatory Activities (MedDRA) version 17.0 was used.|Day 1 to 30 days Post Last Dose|Treated population: All participants who received at least one dose of study medication were analyzed.||participants|||Number
8949|NCT02074358|Secondary|Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. T-HALF was measured in hours|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||hours||Standard Deviation|Mean
8950|NCT02074358|Secondary|Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Cmin was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8951|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
8952|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-24) was measured in ng*h/mL.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8953|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
8954|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-12) was measured in ng*hours/mL (ng*h/mL)|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
8955|NCT02074358|Secondary|Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Tmax was measured in hours.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||hours||Full Range|Median
8981|NCT02073656|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24||Baseline; Week 12, Posttreatment Weeks 12 and 24|Participants in the Safety Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
8982|NCT02073656|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment||Weeks 4, 8, and 12|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
8956|NCT02074358|Secondary|Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) assay within the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
8957|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||fraction||95% Confidence Interval|Mean
8958|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, pre-apixaban dose. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||seconds||95% Confidence Interval|Mean
8959|NCT02074358|Primary|PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. A dedicated software program (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting “thrombogram” curve. Pre-dose Apixaban baseline was Day 1 pre-dose (0 hour). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period.|Day 1 pre-dose apixaban (pre-apixaban Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM*minute||95% Confidence Interval|Mean
8960|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour (pre-dose apixaban). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA velocity index was measured in nM/min.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM/min||95% Confidence Interval|Mean
8961|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM||95% Confidence Interval|Mean
9089|NCT02067728|Secondary|BMI Z-score Change for Ages 4-10 Years||Baseline and 6 months post encounter|||BMI z-score||Standard Deviation|Mean
8962|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||minutes||95% Confidence Interval|Mean
8963|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Anti-FXa activity was measured using a validated method at Esoterix Coagulation Laboratory (Englewood, CO) using the Diagnostica Stago Rotachrom (Registered) Heparin assay on a STA-Compact (Registered) analyzer. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. The results of this chromogenic assay were reported in low molecular weight heparin (LMWH) activity units per milliliter (U/mL), which are equivalent to international units per milliliter (IU/mL) with assay reportable range: 0.1 to 18.4 IU/mL.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||U/mL||95% Confidence Interval|Mean
8964|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||fraction||95% Confidence Interval|Mean
8965|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. PT (Neoplastin CT+), PT (Recombiplastin 2G) and activated partial thromboplastin time (aPTT) parameters were measured in seconds.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||seconds||95% Confidence Interval|Mean
8966|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Velocity Index parameter was measured in nM per minute (nM/min).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM/min||95% Confidence Interval|Mean
8977|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||percentage of participants|||Number
8978|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.||log10 IU/mL||Standard Deviation|Mean
8967|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Peak height parameter was measured in nanomolar (nM).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM||95% Confidence Interval|Mean
8968|NCT02074358|Secondary|PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Lag Time and Time to Peak parameters were measured in minutes.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||minutes||95% Confidence Interval|Mean
8969|NCT02074358|Primary|Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. Dedicated software (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting “thrombogram” curve. Pre-infusion baseline= sample on Day 4, 3 hours post apixaban dose (just prior to IV infusion of PCC or placebo). Samples on Day 4 were obtained at 0 (pre-dose), 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. ETP was measured as nanomolar*minute (nM*min).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.||nM*min||95% Confidence Interval|Mean
8970|NCT02074345|Secondary|Geometric Mean Titer (GMT) of Anti-PRP Antibody|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.||μg/mL||95% Confidence Interval|Geometric Mean
8971|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.||percentage of participants||95% Confidence Interval|Number
8972|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.||percentage of participants||95% Confidence Interval|Number
8973|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Systemic Reactions|Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.||participants|||Number
8974|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Local Reactions|Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.||participants|||Number
8975|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)|Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.||participants|||Number
8976|NCT02074345|Primary|Number of Participants With Adverse Events|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.|For 64 Weeks|Full Analysis Set (FAS) included all participants who received at least 1 dose of the study vaccination.||participants|||Number
30293|NCT01600287|Other Pre-specified|Induction Dose of Propofol|Dose of propofol needed for induction|10 minutes|||mg per kg body weight||Standard Deviation|Mean
8983|NCT02073656|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
8984|NCT02073656|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8||Baseline; Weeks 1, 2, 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
8985|NCT02073656|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
8986|NCT02073656|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
8987|NCT02073656|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
8988|NCT02073656|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who enrolled and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
8989|NCT02073461|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8990|NCT02073461|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8991|NCT02073461|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8992|NCT02073461|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8993|NCT02073461|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8994|NCT02073461|Secondary|Percent of Subjects With Adverse Events|Adverse events which were observed in 5% or more patients with either group are listed.|up to 12 weeks|||percentage of participants|||Number
8995|NCT02073461|Primary|Changes From Baseline in Total Lesion Counts|Median percent reductions from Baseline in total lesion count (ITT-LOCF)|Baseline - Week 12|||percentage of reduction||Full Range|Median
8996|NCT02073448|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8997|NCT02073448|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8998|NCT02073448|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
8999|NCT02073448|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
9000|NCT02073448|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks|||participants|||Number
9001|NCT02073448|Secondary|Percent of Subjects With Adverse Events||up to 12 weeks|||percentage of participants|||Number
9002|NCT02073448|Primary|Changes From Baseline in Total Lesion Counts||Baseline - Week12|||percentage of reduction||Full Range|Median
9003|NCT02072980|Secondary|Average Coefficient of Friction at 15 Minutes|Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 15 minutes|This analysis population includes all participants who completed the study.||unitless||Standard Deviation|Mean
9004|NCT02072980|Primary|Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn|Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 16 hours|This analysis population includes all participants who completed the study.||unitless||Standard Deviation|Mean
9005|NCT02072421|Secondary|Major Vascular Complications|Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure.|30 days|||participants|||Number
9006|NCT02072421|Secondary|Revascularization|Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure|30 days|||participants|||Number
9007|NCT02072421|Secondary|Stroke|Stroke through 30 days post-procedure|30 days|||participants|||Number
9008|NCT02072421|Secondary|All-Cause Mortality|all-cause mortality through 30 days post-procedure|30 days|||participants|||Number
9009|NCT02072421|Primary|Major Adverse Cardiac Event (MACE)|MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days.|30-days|||participants|||Number
9010|NCT02072200|Secondary|Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12|Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects.|12 weeks|ITT set was 145 patients, but 11 patients data was not assessed except baseline score.||scores on a scale||Standard Deviation|Mean
9011|NCT02072200|Secondary|Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale|The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking.|Baseline and 12 weeks|ITT population was 145, but 3 patients were not assessed for primary efficacy parameter of morning stiffness severity. So, Last Observation Carried Forward (LOCF) was not done for these 3 patients after baseline . Other patients' missing data were handled using LOCF method.||mm||Standard Deviation|Mean
9012|NCT02072200|Primary|Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary|"Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.~Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure."|Baseline and 12 weeks|ITT set = 145 patients. Missing data was handled as LOCF.||minutes||Standard Deviation|Mean
9013|NCT02072096|Other Pre-specified|Change From Baseline in Mini-mental State Examination (MMSE) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.|||||
9014|NCT02072096|Other Pre-specified|Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.|||||
9015|NCT02072096|Other Pre-specified|Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.|||||
9016|NCT02072096|Secondary|Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)|The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline eGFR data.||milliliter per minute/1.73 square meter||Standard Deviation|Mean
9017|NCT02072096|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline BMI data.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
9018|NCT02072096|Secondary|Change From Baseline of Urinary Albumin to Creatinine Ratio|The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline urinary albumin to creatinine ratio.||milligram per millimole (mg/mmol)||Standard Deviation|Mean
9019|NCT02072096|Secondary|Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.||Participants|||Number
9020|NCT02072096|Secondary|Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.||percentage of participants|||Number
9021|NCT02072096|Primary|Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia|Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c > upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c > upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose <3.0 mmol/L. Success is defined as lacking of failure.|Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
9022|NCT02071823|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067|Day 1|||ng·h/mL||Standard Deviation|Mean
9023|NCT02071823|Primary|AUCt - Cumulative Area Under the Plasma Concentration Time Curve|AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067|Day 1|||ng·h/mL||Standard Deviation|Mean
9024|NCT02071823|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of BIA 9-1067|Day 1|||ng/mL||Standard Deviation|Mean
9025|NCT02071810|Primary|Number of Patients With at Least One Adverse Event||participants will be followed for the duration of hospital stay, an expected average of 6 weeks|||Number of patients|||Number
9026|NCT02071771|Secondary|Lens Oscillation at Blink at Day 10|Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.|Day 10, each product|This analysis group includes all randomized subjects at the UK site with data at visit who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.||degrees||Standard Deviation|Mean
9027|NCT02071771|Primary|High Contrast Time Controlled Visual Acuity (TCVA) at Day 10|TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.||VA units||Standard Deviation|Mean
9028|NCT02071108|Other Pre-specified|Exploratory Endpoint|The clinical protocol provided for an Exploratory Secondary Endpoint to assess the ability of the device to achieve ≤30% residual stenosis without adjunctive PTA as assessed by the investigator via visual estimate.|Day of Procedure|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|Participants||Number
9029|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||Rutherford Clinical Category||95% Confidence Interval|Mean
9030|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Improvement of Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Lithoplasty treatment was successfully completed||Ankle Brachial Index||95% Confidence Interval|Mean
9031|NCT02071108|Secondary|Patency|Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|Participants|95% Confidence Interval|Number
9032|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 6 months|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|Participants||Number
9033|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 6 months|6 months|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of participants|||Number
9034|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||change in RCC from baseline||95% Confidence Interval|Mean
9035|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Improvement of Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed. Four subjects were not included in the analysis because ABI could not be measured due to non-compressible disease that inhibited accurate ABI measurement.||change in ABI score from baseline||95% Confidence Interval|Mean
9036|NCT02071108|Secondary|Patency|Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5).|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted. Due to device malfunctions, one subject received partial treatment. To provide a more accurate account of actual device usage, the subject was omitted from the analysis of device usage only.||percentage of lesions|Participants|95% Confidence Interval|Number
9037|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 30 days|30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed||percentage of lesions|Participants||Number
9038|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 30 days.|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of participants|||Number
9039|NCT02071108|Secondary|Technical Success:|The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of lesions|Participants|95% Confidence Interval|Number
9040|NCT02071108|Secondary|Clinical Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted||percentage of participants||95% Confidence Interval|Number
9041|NCT02071108|Secondary|Device Success|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment attempted||percentage of lesions|Participants|95% Confidence Interval|Number
9042|NCT02071108|Primary|Procedural Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted.||percentage of lesions|Participants|95% Confidence Interval|Number
9043|NCT02071108|Primary|Composite of New-onset Major Adverse Events (MAE)|Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.|30 days|||participants|||Number
9044|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 48|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Inter-Quartile Range|Median
9045|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 24|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Inter-Quartile Range|Median
9046|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBe at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
9047|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
9048|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBs at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
9049|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.||percentage of participants|||Number
9050|NCT02071082|Secondary|Percentage of Participants With Normalized ALT at Week 48|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 48|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.||percentage of participants|||Number
9051|NCT02071082|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 24|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.||percentage of participants|||Number
9052|NCT02071082|Secondary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.|Week 48|Full Analysis Set||percentage of participants|||Number
9053|NCT02071082|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set||percentage of participants|||Number
9054|NCT02071082|Primary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.|Week 24|Full Analysis set||percentage of participants|||Number
9055|NCT02071082|Primary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, had at least 1 post-Day 1 plasma HBV DNA or HIV-1 RNA result while on study, and had no major protocol violations from the eligibility criteria.||percentage of participants|||Number
9056|NCT02070640|Secondary|Time to Complete NIRF-C and IOC|The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.|Intraoperative|||minutes||Full Range|Mean
9057|NCT02070640|Secondary|Incidence of Anatomic Identification With NIRF-C|Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.|Intraoperative|||percentage of biliary anatomy observatio|||Number
9058|NCT02070640|Primary|Complications Related to ICG|A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.|From time of injection to 1st post-op follow-up|||% of Participants with Complications|||Number
9059|NCT02070380|Secondary|Lesion-brain Contrast-to-noise Ratio|"The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is the mean difference in CNR (MultiHance - Dotarem)"|5-10 minutes Postdose|||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
9105|NCT02066727|Secondary|Complication Related With Nerve Block|Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively|during operation, 0.5,24hour postoperatively||||||
12656|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
9060|NCT02070380|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is “the mean difference in LBR postdose (MultiHance – Dotarem)”|5-10 minutes Postdose|||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
9061|NCT02070380|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||Participant Exams|||Number
9062|NCT02070380|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||participant exams|||Number
9063|NCT02070380|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||participant exams|||Number
9064|NCT02070380|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|||participant exams|||Number
9065|NCT02070380|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations||participant exams|||Number
9066|NCT02070237|Secondary|Supraprophylactic Range Anti Xa Level|We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).|3.5-4 hours after the third dose of Lovenox (enoxaparin)|||participants|||Number
9067|NCT02070237|Primary|Anti Xa Level|Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.|3.5-4 hours after the third dose of Lovenox (enoxaparin)|||IU/mL||95% Confidence Interval|Mean
9068|NCT02069093|Secondary|Blood Concentration of Everolimus and Exemestane|Blood samples were collected and analyzed.|28 days (pre-dose)|The PK analysis set, which was a subset of the FAS, was considered for the analysis. However, only participants who had evaluable data were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9069|NCT02069093|Secondary|Dose Intensity of Everolimus and Exemestane|The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||mg/day||Full Range|Median
9070|NCT02069093|Secondary|Number of Participants With All Grades of Stomatitis|The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|The FAS, consisting of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash), was considered for the analysis. However, only those participants, who were evaluable for stomatitis grade, were analyzed.||Participants|||Number
9071|NCT02069093|Secondary|Median Number of Mouthwashes Per Day|The median number of mouthwashes per day was assessed.|56 days|FAS: The FAS set consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||Number of mouthwashes||Full Range|Median
9072|NCT02069093|Secondary|Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less|The number of days to achieve resolution of stomatitis from grade 2 or greater to grade 1 or less was assessed. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||Days||Full Range|Median
9073|NCT02069093|Primary|Number of Participants With Stomatitis Grade ≥ 2|The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|Full analysis set (FAS): The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).||Participants|||Number
9074|NCT02068443|Secondary|Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings|Number of participants who had ECG findings changed from “normal” or “abnormal but not clinically relevant” at Baseline to “abnormal and clinically relevant”.|Baseline and Weeks 12 and 24|"Safety Analysis Set, all participants who received at least 1 dose of study drug, with ECG values normal or abnormal not clinically significant at Baseline."||participants|||Number
9075|NCT02068443|Secondary|Percentage of Participants With TEAEs Related to Vital Signs|Vital signs included sitting systolic and diastolic blood pressures (mmHg) (measured after resting for ≥ 5 minutes) and pulse rate (beats per minute [bpm]).|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
9076|NCT02068443|Secondary|Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis|The percentage of participants with any clinically relevant safety laboratory changes (chemistry, hematology and urinalysis) collected throughout study and recorded as AEs.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
9077|NCT02068443|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
9078|NCT02068443|Secondary|Fasting Blood Glucose|The value of the fasting plasma glucose collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||mg/dL||Standard Deviation|Mean
9079|NCT02068443|Secondary|Change From Baseline in Fasting Blood Glucose|The change in the value of the fasting plasma glucose collected at Weeks 2, 4, 8, 12, 16, 20 and 24 relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||mg/dL||Standard Deviation|Mean
9080|NCT02068443|Secondary|Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period|HbA1c (NGSP) is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The percentage of participants with HbA1c levels of ≥6.0, ≥7.0 and ≥8.0 at the end of Screening (Baseline) with change to target values <6.0, <7.0 and <8.0 respectively at EOT.|Baseline and EOT (Up to Week 24)|FAS included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
9081|NCT02068443|Secondary|HbA1c (NGSP)|The value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||percent||Standard Deviation|Mean
9082|NCT02068443|Secondary|Change From Baseline in HbA1c (NGSP)|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 2, 4, 8, 12, 16, 20, 24, and EOT relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.||percent||Standard Deviation|Mean
9083|NCT02068443|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses.|Baseline and End of Treatment (EOT) (Up to Week 24)|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.||percent||Standard Error|Least Squares Mean
9084|NCT02068222|Secondary|The Percentage of Subjects With Post-Treatment Relapse|Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.|Within 12 weeks after the last dose of study drug|||percentage of participants||95% Confidence Interval|Number
9085|NCT02068222|Secondary|The Percentage of Subjects With Virologic Failure During Treatment|Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.|Up to Treatment Week 12|||percentage of participants||95% Confidence Interval|Number
9086|NCT02068222|Secondary|The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)|SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.|24 weeks after last dose of study drug|||percentage of participants||95% Confidence Interval|Number
9087|NCT02068222|Primary|The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)|SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.|12 weeks after last dose of study drug|||percentage of participants||95% Confidence Interval|Number
9088|NCT02067728|Secondary|BMI Z-score Change for Ages 11-17 Years||Baseline and 6 months post encounter|||BMI z-score||Standard Deviation|Mean
9090|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 6 months post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 6 months post encounter.||percentage of participants|||Number
9091|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 1 month post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 1 month post encounter.||percentage of participants|||Number
9092|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 6 months post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|6 months post encounter|This analysis population only includes those participants who initially set an obesiogenic focused goal at their well child check and then responded to the survey 6 months after to rate their success level in achieving that goal.||percentage of participants|||Number
9093|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 1 month post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|1 month post encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 1 month after the medical encounter to rate their level of success in achieving that goal.||percentage of participants|||Number
9094|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 6 months after the encounter. Success defined as response of 2-4 on survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months after encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 6 months after the medical encounter when goal was set.||percentage of participants|||Number
9095|NCT02067728|Other Pre-specified|Obesity Follow-up Adherence|Subjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter|6 months after the encounter|This analysis population only includes the subjects who were identified as obese at their initial appointment and had a 6 month follow up appointment scheduled at that time.||percentage of participants|||Number
9096|NCT02067728|Other Pre-specified|Perception of Patient Centeredness of Encounter|Patient centeredness survey which measures the parent's and patient's (if 12 years and older) perception of how patient centered the communication was with the provider. Survey Coding for Patient Centeredness: 1=Not at all; 2=A little; 2.5=Can't say; 3=Somewhat; 4=A lot|1 month after the encounter|||units on a scale||Standard Deviation|Mean
9097|NCT02067728|Other Pre-specified|BMI Z-score Change for All|Anthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter.|Baseline and 6 months after the encounter|The number of participants analyzed is low because returning for measurement checks was optional at 6 months & only 28% usual care and 27% intervention group attended. We also included chart abstraction measurements for those who had a return clinic visit with measurements within 6 months +/- 2 months from initial encounter.||BMI z-score||Standard Deviation|Mean
9098|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 1 month after the encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month after the encounter|This analysis population only includes the participants who set an obesiogenic goal at the initial appointment and completed the 1 month post survey to rate their success level in achieving that goal.||percentage of participants|||Number
9099|NCT02067728|Primary|Percentage of Patients With Documented Goal Setting|Health behavior change goal documented in charting of well-child visits.|2 weeks from encounter|Manual chart review of the electronic medical record (EMR) was completed by the Research Team for all enrolled subjects in both study groups. Goal documentation was defined as any type of goal consisting of an active verb written either on the FNPA Tool which was completed during the well child visit or in Physician notes in the EMR for the visit.||percentage of participant charts|||Number
9100|NCT02067533|Primary|Knee Range of Motion (ROM)|in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.|1 year after total knee arthroplasty|||degree||Standard Deviation|Mean
9101|NCT02066922|Secondary|Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1|Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject’s current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.|Baseline, Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.||Eyes|||Number
9102|NCT02066922|Primary|Change in Average Central Corneal Curvature From Dispense at Week 1|Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.|Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.||diopters||Standard Deviation|Mean
9103|NCT02066740|Primary|Successful Stent Deployment|Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.|Procedure|||percentage - successful stent deployment|Participants||Number
9104|NCT02066740|Primary|Absence of Stent Elongation|Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length|Intra operative|||percentage absence of stent elongation|Participants||Number
9106|NCT02066727|Primary|Median Effective Concentration(EC50)|"Median effective concentration(EC50) was not calculated per-participants, the up-and-down sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration.~For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows."|10min|||mg/ml(the concentration of lidocaine)||95% Confidence Interval|Number
9107|NCT02066051|Secondary|Number of Participants Who Experienced Adverse Events|Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.|12 months|||participants|||Number
9108|NCT02066051|Primary|Number of Participants Who Responded to Intense Pulsed Light (IPL)|Participants received treatment over 4 months and were monitored for safety and response for an additional 8 months. The symptoms were scored with the Standard Patient Evaluation of Eye Dryness (SPEED2) questionnaire. The SPEED questionnaire presents the four most commonly experienced dry eye symptom groups and asks patients to tick a box for all symptoms that apply to them. The frequency section ratings run from 0 (never) to 3 (constant), and the severity section ratings run from 0 (no problems) to 4 (intolerable), for a total score ranging from 0 (no problem) to 28 (severe problems). Over a 30% improvement in the SPEED2 score equated a response. None of the subjects were expected to get a complete response due to the nature of the damage to their ocular surface from GVHD.|12 months|||participants|||Number
9109|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)|To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
9110|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)|To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
9111|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Bicarbonate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Bicarbonate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
9112|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Blood Urea Nitrogen"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
9113|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Protein|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Protein"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||g/L||Standard Deviation|Mean
9114|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Albumin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Albumin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||g/L||Standard Deviation|Mean
9115|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Phosphate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Phosphate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
9116|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Chloride|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Chloride"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
9117|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Potassium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Potassium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
9118|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Sodium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Sodium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
9119|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Total Bilirubin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Total Bilirubin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||umol/L||Standard Deviation|Mean
9120|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Creatinine|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Creatinine"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||umol/L||Standard Deviation|Mean
9121|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alkaline Phosphatase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ukat/L||Standard Deviation|Mean
9122|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Aspartate Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ukat/L||Standard Deviation|Mean
9123|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alanine Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ukat/L||Standard Deviation|Mean
9124|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Glucose|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Glucose"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmol/L||Standard Deviation|Mean
9125|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Platelets|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Platelets"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||10^9/L||Standard Deviation|Mean
9126|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Leukocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Leukocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||10^9/L||Standard Deviation|Mean
9127|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Hemoglobin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Hemoglobin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||g/L||Standard Deviation|Mean
9128|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Erythrocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Erythrocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||10^12/L||Standard Deviation|Mean
9129|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Geometric Coefficient of Variation|Geometric Mean
9130|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
9131|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
9132|NCT02064985|Secondary|Safety---Vital Signs Over Time---Pulse Rate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Pulse Rate)"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||BEATS/MIN||Standard Deviation|Mean
9133|NCT02064985|Secondary|Safety---Vital Signs Over Time---Weight|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Weight)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||kg||Standard Deviation|Mean
12657|NCT01953328|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
9134|NCT02064985|Secondary|Safety---Vital Signs Over Time---Height|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Height)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||cm||Standard Deviation|Mean
9135|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(4)|Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Geometric Coefficient of Variation|Geometric Mean
9136|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(3)|Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
9137|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(1)|The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9138|NCT02064985|Secondary|Safety---Causally Related Adverse Events by System Organ Class and Preferred Term|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Assessment of adverse events"|Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||Participants|||Number
9139|NCT02064985|Secondary|Safety---All Allowed Concomitant Medications During Study Treatment|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Concomitant medications"|All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||Participants|||Number
9140|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---hematocrit|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---hematocrit"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||ratio||Standard Deviation|Mean
9141|NCT02064985|Secondary|Safety---Physical Examination, Summary of Abnormalities|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Physical examination"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||Participants|||Number
9142|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax|To determine Cmax ratio of metabolite to that of the parent compound on Day 7|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
9143|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax|To determine Cmax ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ratio||Standard Deviation|Mean
9144|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
9145|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9146|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
9186|NCT02063516|Secondary|Anatomic Position|This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O.|5 min|"Fiber-optic scoring system:~1, clear view of vocal cord 2, Only arytenoids visible 3, Only epiglottis visible 4, No laryngeal structures visible"||participants|||Number
9147|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9148|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(2)|The pharmacokinetics parameters of ticagrelor on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
9149|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(2)|The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
9150|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(3)|The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||hour||Full Range|Median
9151|NCT02064985|Secondary|AUEC(Final Extent) on Day 7|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||%*h||Standard Deviation|Mean
9152|NCT02064985|Secondary|AUEC(Final Extent) on Day 1|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||%*h||Standard Deviation|Mean
9153|NCT02064985|Secondary|TIPA(Max)---Day 7|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||hour||Inter-Quartile Range|Median
9154|NCT02064985|Secondary|TIPA(Max)---Day 1|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||hour||Inter-Quartile Range|Median
9155|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 7|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||% change from baseline||Standard Deviation|Mean
9156|NCT02064985|Primary|IPA on Day 7|"The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||% IPA||Standard Deviation|Mean
9157|NCT02064985|Secondary|Safety---Vital Signs Over Time---Blood Pressure|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (seated blood pressure [BP])"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.||mmHg||Standard Deviation|Mean
9158|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(1)|Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9159|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 1|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (e.g., non-compliance with study drug) will be included in the PD analysis set.||% change from baseline||Standard Deviation|Mean
9160|NCT02064985|Primary|IPA on Day 1|"The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).||% IPA||Standard Deviation|Mean
9161|NCT02064907|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5|AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
9162|NCT02064907|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1|AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
9163|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
9164|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng*hr/mL||Standard Deviation|Mean
9165|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng/mL||Standard Deviation|Mean
9166|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.||ng/mL||Standard Deviation|Mean
9167|NCT02064231|Primary|Degree of Leakage|Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).|14 days|||units on a scale|Participants|Standard Deviation|Mean
9168|NCT02064205|Secondary|Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.|"The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between.~The satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B).~Area under the curves were calculated of the time curves."|Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.|Only in condition A and B blood was drawn and satiety hormones were analyzed.||(mcg*min)/mL||Standard Deviation|Mean
9169|NCT02064205|Secondary|The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)|The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)|one day|||mm*min||Standard Deviation|Mean
9170|NCT02064205|Primary|Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.|Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.|Four hours or 1.5 hour after consumption of a pre-load at up to day 22|Energy intake||kJ||Standard Deviation|Mean
9171|NCT02063737|Secondary|Intentions Subscale of the SFAB|An individual’s intent to engage in behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work with higher scores indicating greater intent. Range is 0 (strongly agree) to 100 (strongly disagree).|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9172|NCT02063737|Secondary|Habits Subscale of the SFAB|Endorsement of behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work ranging from 0 (strongly agree) to 100 (strongly disagree). Strongly agree (lower score) is associated with high level of endorsement of behaviors (habits) that promote improved alertness.|end of study at the 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9187|NCT02063516|Primary|Oropharyngeal Seal Pressure|This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.|5 min|||cmH2O||Standard Deviation|Mean
9188|NCT02063230|Primary|Dose Normalized Cmax, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
9173|NCT02063737|Secondary|Environmental Constraints Three Subscale of the SFAB|Degree of importance of personal/work-life barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her responsibilities unrelated to the organization as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9174|NCT02063737|Secondary|Environmental Constraints Two Subscale of the SFAB|Degree of importance of employer policies that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer’s policies and organizational related procedures/protocols as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9175|NCT02063737|Secondary|Environmental Constraints One Subscale of the SFAB|Degree of importance of employer based barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer’s policies and organizational related procedures/protocols as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9176|NCT02063737|Secondary|Importance Subscale of SFAB|Level of importance an individual places on the need to maintain alertness and reduce feelings of fatigue and/or sleepiness while at work ranging from 0 (strongly disagree) to 100 (strongly agree). Strongly agree (higher score) is associated with high level of importance (endorsement) placed on the need to maintain alertness and reduce feelings of fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9177|NCT02063737|Secondary|Knowledge-two Subscale of the SFAB|Perceived degree of evidence that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9178|NCT02063737|Secondary|Knowledge-one Subscale of SFAB|Perception that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9179|NCT02063737|Secondary|Self Efficacy Subscale of the SFAB|Degree of confidence from 0 (cannot do at all) to 100 (highly certain can do) for completing activities. Higher scores indicate the individual has a high-level of self-confidence he/she can perform select behaviors that may improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9180|NCT02063737|Secondary|Normative Beliefs Scale Two Subscale of the SFAB|Belief of people's views if they thought you were very fatigued mentally or physically while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9181|NCT02063737|Secondary|Normative Beliefs Scale One Subscale of the SFAB|Belief of people's views if they thought you were sleepy and fighting the urge to sleep while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9182|NCT02063737|Secondary|Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work on future shifts. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9183|NCT02063737|Secondary|Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|Assessed at the end of 90-day study period|Intention to treat among participants with 90 day data (completers)||units on a scale||Standard Deviation|Mean
9184|NCT02063737|Primary|Self-Reported Fatigue at End of Shift Work|Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).|At the end of scheduled work shifts during a 90 day study period|Analysis using intention to treat.||units on a scale|Participants|Standard Error|Least Squares Mean
9185|NCT02063516|Other Pre-specified|Amount of Air Added to Keep Cuff Pressure 60cmH20.|The accuracy of the intrinsic cuff pressure indicator is assessed by documenting which colour band the indicator is displaying when inflated according to manufacturers instructions, and measuring the numeric cuff pressure at the same time with a standard analogue cuff pressure gauge. The manufacturer has documented what pressure range is meant to be indicated by each of three colour ranges.|30 minutes, 60 minutes, 90 minutes and 120 minutes|||ml||Standard Deviation|Mean
9189|NCT02063230|Primary|Dose Normalized AUC, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
9192|NCT02063230|Primary|Cmax of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised Cmax outcome measure||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9193|NCT02063230|Primary|AUC (0 to Infinity) of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised AUC outcome measure||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
9194|NCT02062905|Secondary|Conjunctival Redness|"Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; 0 = no redness)"|14 days post insertion|||units on a scale (0 - 4)||Standard Deviation|Mean
9195|NCT02062905|Primary|Ocular Itching|"Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; 0 = no itching)"|14 days post insertion|||units on a scale (0 -4)||Standard Deviation|Mean
9196|NCT02062801|Secondary|Urgent Cesarean Delivery|Incidence of urgent cesarean delivery|Within 30 minutes of combined spinal epidural (CSE) placement|||participants|||Number
9197|NCT02062801|Secondary|Tetanic (Sustained) Uterine Contraction (TUC)|Incidence of Tetanic (sustained) Uterine Contraction (TUC)|Within 30 minutes of combined spinal epidural (CSE) placement|||participants|||Number
9198|NCT02062801|Primary|Early Profound Fetal Bradycardia|Incidence of early profound fetal bradycardia|Within 30 minutes of combined spinal epidural (CSE) placement|||participants|||Number
9199|NCT02062710|Primary|Change in Cough Reflex Sensitivity to Capsaicin|increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|2 hours after study drug administration|||log C5 (uM)||Standard Error|Mean
9200|NCT02062658|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|2 weeks|||participants|||Number
9201|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2||Up to 5 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2.||Percentage of participants|||Number
9202|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1||Up to 5 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.||Percentage of participants|||Number
9203|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2||Up to 42 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2||Percentage of participants|||Number
9204|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1||Up to 42 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.||Percentage of participants|||Number
9205|NCT02062502|Secondary|Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)||Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)|The analysis population is All Subjects as Treated with temperature data at the time of assessment.||Percentage of participants|||Number
9206|NCT02062502|Primary|Geometric Mean Titer of VZV Antibodies|Antibody titers were measured with gpELISA.|6 weeks (43 days) after vaccination 1|The analysis population is participants with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
9207|NCT02062502|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL||6 weeks (43 days) after vaccination 1|The analysis population is participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.||Percentage of participants|||Number
9208|NCT02062450|Primary|Implant Survivorship|Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.|2-year postoperative|||percentage of implants|||Number
9209|NCT02062450|Secondary|Clinical Performance - HARRIS Score|The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered “excellent”, between 80 and 90 “good”, between 70 and 80 “mediocre” and less than 70 “poor”.|2-year postoperative|||percentage of partipants|||Number
9210|NCT02062450|Secondary|Clinical Performance - HOOS Score|The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.|2 years postoperative|||units on a scale of 100||Standard Deviation|Mean
9211|NCT02062450|Secondary|Clinical Performance - PMA Score|"Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician.~It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) :~a score between 15 and 18 points is defined as good,~a score between 12 and 14 points is defined as average,~a score inferior to 12 is defined as bad"|2 years postoperative|||units on a scale||Standard Deviation|Mean
9212|NCT02062450|Primary|Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative|||percentage of participants|||Number
32659|NCT01560260|Secondary|Failure-free Survival|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks||||||
9213|NCT02062450|Primary|Number of Participants With an Implant Dislocation After Surgery|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative|2 implants dislocations were reported in the 379 patients making up the Total Safety Population, of which 1 concerned a Primary surgery and the other concerned a Revision surgery. In both cases, orthopaedic reduction was performed without changing the implant.||participants|||Number
9214|NCT02062437|Other Pre-specified|General Performance: Radiological Assessment.|"Radiological assessment is based on :~Cup radiological signs of osteolysis or radiolucencies.~Stem radiological signs of osteolysis or radiolucencies.~Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification)~Other Radiological signs"|2-year Follow-up visit|Patients with X-ray data available||participants|||Number
9215|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|2-year follow-up visit|Wthin per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.||score on a scale||Standard Deviation|Mean
9216|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).~Normal values (usually observed range of motions) are:~extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).~Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|2-year Follow-up visit|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities||Degrees||Standard Deviation|Mean
9217|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|Baseline|Wthin per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.||score on a scale||Standard Deviation|Mean
9218|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).~Normal values (usually observed range of motions) are:~extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).~Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|Baseline|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilites||Degrees||Standard Deviation|Mean
9219|NCT02062437|Primary|Number of Participants With Adverse Events|"Surgical incidents.~Post-operative complications.~Failure and revisions analysis."|2-year follow-up visit|The total of 80 patients were seen for their 2-Year follow-up visit.||participants|||Number
9220|NCT02062385|Secondary|Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens|The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers >=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers >=0.1 IU/mL, 3) antipertussis toxin antibody titers >=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers >=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI.|Baseline and between 28 and 51 days after the third DTaP vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.||Percentage of participants||95% Confidence Interval|Number
9221|NCT02062385|Secondary|Percentage of Participants With Any Adverse Event|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor’s product, is also an adverse event.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up||Percentage of participants|||Number
9222|NCT02062385|Secondary|Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3|The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer >=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV.|Baseline and between 28 and 56 days after the third OPV vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.||Percentage of participants||95% Confidence Interval|Number
9223|NCT02062385|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis|The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as >=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.||Participants|||Number
20574|NCT01763905|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
9224|NCT02062385|Secondary|Percentage of Participants With Intussusception|Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed.|Up to 15 months|All Subjects as Treated with safety follow-up||Percentage of participants|||Number
9225|NCT02062385|Secondary|Percentage of Participants With Vomiting or Diarrhea|Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up||Percentage of participants|||Number
9226|NCT02062385|Secondary|Percentage of Participants With Elevated Temperature|Elevated temperature (temperature >=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature >=37.5 °C or an adverse event of pyrexia was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with follow-up specific to the endpoint||Percentage of participants|||Number
9227|NCT02062385|Primary|Number of Participants With Any Severity of Rotavirus Gastroenteritis|The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.||Participants|||Number
9228|NCT02062359|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 months|||participants|||Number
9229|NCT02062359|Secondary|Persistence of Genetically Engineered, Adoptively Transferred Cluster of Differentiation 62L (CD62L) + Derived Lymphocytes|Estimate the persistence of cells via enzyme linked immunosorbent spot (ELISPOT) and tetramer analysis by fluorescence activated cell sorting (FACS).|3 months|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 22 subjects was needed to perform an analysis.|||||
9230|NCT02062359|Primary|Objective Response (Complete Response (CR) + Partial Response (PR)) of Melanoma Tumors|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 months|None of the participants achieved a complete response or partial response and no data were collected for this assessment.|||||
9231|NCT02062294|Secondary|Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|6 months|Safety Analysis population (SAP) comprised all 14 participants which entered study.||participants|||Number
9232|NCT02062294|Primary|Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis|Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.|6 months|Per Protocol (PP) population comprised all 14 participants receiving Valganciclovir within 10 days post-transplantation for at least 70 days and for whom source data from the time period between liver transplantation until 6 months post-transplantation was available.||participants|||Number
9233|NCT02062177|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)|one day||||||
9234|NCT02062177|Secondary|Time (Minutes) to Dischargeability of Patient From Endoscopic Unit|After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.|one day||||||
9235|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure|Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)|at 24-72 hours after procedure|||units on a scale||Standard Deviation|Mean
9236|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge|When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)|before discharge|||units on a scale||Standard Deviation|Mean
9237|NCT02062177|Primary|Endoscopist's Satisfaction (Visual Analog Scale) About Sedation|Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist|at the end of the exam|||units on a scale||Standard Deviation|Mean
12658|NCT01953328|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
9238|NCT02061683|Secondary|Percentage of Patients With an Adverse Event of Conjunctival Hyperemia|Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|3 Months|Safety population defined as all enrolled patients who completed at least 1 follow-up visit||Percentage of Patients|||Number
9239|NCT02061683|Primary|Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).|Month 3|All enrolled patients with data available for analysis||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
9240|NCT02061592|Primary|Monocular logMar Visual Acuity - Standard Low Contrast Bright|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1- week Follow-up|Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.||LogMar|Participants|Standard Deviation|Mean
9241|NCT02061592|Primary|Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1-week follow-up|Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.||LogMar|Participants|Standard Deviation|Mean
9242|NCT02061592|Primary|Overall Vision|Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1- week Follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.||units on a scale||Standard Deviation|Mean
9243|NCT02061592|Primary|Overall Comfort|Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1-week follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.||units on a scale||Standard Deviation|Mean
9244|NCT02061358|Secondary|CLr by Treatment Group: UV-4|CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing.L/h||L/h||Geometric Coefficient of Variation|Geometric Mean
9245|NCT02061358|Secondary|Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group|fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||percentage of dose||Standard Deviation|Mean
9246|NCT02061358|Secondary|Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group|Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.||mg||Standard Deviation|Mean
9247|NCT02061358|Secondary|t(1/2) by Treatment Group: UV-4|t(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||hours||Full Range|Median
9286|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
9248|NCT02061358|Secondary|Vz/F by Treatment Group: UV-4|Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by [λ(z) × AUC(0-inf)].|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||L||Geometric Coefficient of Variation|Geometric Mean
9249|NCT02061358|Secondary|CL/F by Treatment Group: UV-4|CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||L/h||Geometric Coefficient of Variation|Geometric Mean
9250|NCT02061358|Secondary|AUC(0-inf) by Treatment Group: UV-4|AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
9251|NCT02061358|Secondary|AUC(0-last) by Treatment Group: UV-4|AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
9252|NCT02061358|Secondary|Tmax by Treatment Group: UV-4|Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||hours||Full Range|Median
9253|NCT02061358|Secondary|Cmax by Treatment Group: UV-4|Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9254|NCT02061358|Primary|Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group|Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.|Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Participants|||Number
9255|NCT02061358|Primary|Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group|Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||participants|||Number
9256|NCT02061358|Primary|Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)|Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Participants|||Number
9257|NCT02061358|Primary|Subjects With Serious Adverse Event (SAEs) by Treatment Group|Subjects with AEs considered serious by the investigator|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Subjects with at least 1 SAE|||Number
9258|NCT02061358|Primary|Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group|TEAEs are those AEs occurring only after administration of investigational product|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo||Subjects with at least 1 TEAE|||Number
9259|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained at 2 weeks."|2 Weeks|||hours||Standard Deviation|Mean
9260|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained for habitual lens at baseline."|Baseline|||hours||Standard Deviation|Mean
9261|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.|2 Weeks|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.||units on a scale|Participants|Standard Deviation|Mean
9262|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.|Baseline|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.||units on a scale|Participants|Standard Deviation|Mean
9263|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.|2 Weeks|||logMar||Standard Deviation|Mean
9264|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||logMar||Standard Deviation|Mean
9265|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.|Baseline|||logMar||Standard Deviation|Mean
9266|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.|2 Weeks|||units on a scale|Participants|Standard Deviation|Mean
9267|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale|Participants|Standard Deviation|Mean
9268|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.|Baseline|||units on a scale|Participants|Standard Deviation|Mean
9269|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.|2 Weeks|||units on a scale|Participants|Standard Deviation|Mean
9270|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale|Participants|Standard Deviation|Mean
9271|NCT02060539|Secondary|Lens Movement - Habitual Lenses|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.|Baseline|||units on a scale|Participants|Standard Deviation|Mean
9272|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.|2 Weeks|||percentage of lenses|Participants||Number
9273|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.|Dispense|||percentage of lenses|Participants||Number
9274|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
9275|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||percentage of participants|||Number
9276|NCT02060539|Primary|Handling Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
9277|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
9278|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||percentage of participants|||Number
9279|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks|||percentage of participants|||Number
9280|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||percentage of participants|||Number
9281|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
9282|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
9283|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
9284|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 weeks|||units on a scale||Standard Deviation|Mean
9285|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
9287|NCT02060539|Primary|Vision Quality (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
9288|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
9289|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
9290|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
9291|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
9292|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
9293|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
9294|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
9295|NCT02060539|Primary|Comfort (Insertion)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
9296|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
9297|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.|2 Weeks|||units on a scale||Standard Deviation|Mean
9298|NCT02060539|Primary|Dryness (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense|||units on a scale||Standard Deviation|Mean
9299|NCT02060539|Secondary|Lens Centration - Habitual Lenses|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.|Baseline|||percentage of lenses|Participants||Number
9300|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
9301|NCT02059993|Primary|Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment||baseline and follow-up at 36 months|4 participants withdrew before the end of study. Two subjects were lost to follow-up in the control group, and 4 patients (all of them had no SCCE) with very poor CPAP compliance were also excluded.||mm Hg||Standard Deviation|Mean
9302|NCT02059993|Other Pre-specified|Cardiovascular and Cerebrovascular Events||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month||||||
9303|NCT02059993|Secondary|Change in Epworth Sleepiness Scale (ESS)||1 month，3 month，6 month，12 month，18 month，24 month，30 month，36 month||||||
9304|NCT02059993|Secondary|Change in Glucose and Lipid Metabolism||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month||||||
9305|NCT02059070|Secondary|Post-operative Oxycodone Use (mg)|The total amount of oxycodone medication (mg) that the patient consumed in the 24 hours post surgery.|The 24 hour period following surgery|||mg||Standard Deviation|Mean
9306|NCT02059070|Other Pre-specified|Highest Patient Pain Level|The Visual analog pain scale ranges from 0 to 10, with higher scores indicating higher pain|Within 36 hours of surgery|||VAS units on a scale||Standard Deviation|Mean
9307|NCT02059070|Secondary|Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test|For ultrasonographic evaluation if caudad movement of the hemidiaphragm was observed, the distance was measured recorded and assigned a positive (+) value. If paradoxical cephalad movement of the diaphragm was observed, the distance was given a negative value (-). Each measurement was performed 3 times and the best value was recorded.|Within 36hrs following surgery|||percentage of baseline change||Standard Deviation|Mean
9308|NCT02059070|Primary|Forced Expiratory Volume at 1 Second (% Change From Baseline)||Within the first 4 days following surgery|||percentage of change from baseline||Standard Deviation|Mean
9323|NCT02058290|Primary|Health Economic Benefits - Length of Stay (LOS)|Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||days||Full Range|Median
9632|NCT02041520|Secondary|Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM||95% Confidence Interval|Mean
9309|NCT02058992|Secondary|Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4|"PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition."|Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||percentage of participants|||Number
9310|NCT02058992|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||number of awakenings||Standard Deviation|Mean
9311|NCT02058992|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||hours||Standard Deviation|Mean
9312|NCT02058992|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.||minutes||Standard Deviation|Mean
9313|NCT02058992|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 weeks|SAS was defined as participants who were enrolled and completed the study.||participants|||Number
9314|NCT02058992|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 6 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.||participants|||Number
9315|NCT02058537|Other Pre-specified|Change From Baseline Composite Vital Signs to Day 7|Vital signs include temperature, heart rate, breathing rate, and blood pressure. This variables will be measured during the study in order to assess any negative systemic effects of the study drug. These measurements are assessed as a composite and not individually therefore are grouped together as one outcome measure.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.|||||
9316|NCT02058537|Secondary|Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7|This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.|||||
9317|NCT02058537|Primary|Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7|The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.|||||
9318|NCT02058498|Secondary|Number of Patients Who Document Their Physical Activity|8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.|Baseline to 6 weeks, repeated measure at 4 months|||participants|||Number
9319|NCT02058498|Secondary|Quality of Life at Baseline, 6 Weeks, and 4 Months|Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.|Baseline, 6 weeks, 4 months|||units on a scale||Standard Deviation|Mean
9320|NCT02058498|Primary|Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)|The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).|Baseline, 6 weeks|||MET||Full Range|Median
9321|NCT02058290|Secondary|Patient Satisfaction With Pain Treatment After Surgery|Responses to question pertaining to patient satisfaction with pain treatment|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||participants|||Number
9322|NCT02058290|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||participants|||Number
9324|NCT02058290|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||dollars||Standard Deviation|Mean
9325|NCT02058290|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.||mg||Standard Deviation|Mean
9326|NCT02058160|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.||percentage of participants|||Number
9327|NCT02058160|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.||percentage of participants|||Number
9328|NCT02058160|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.||events per subject-year|||Number
9329|NCT02058160|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.||percentage of participants|||Number
9330|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.||percentage of participants|||Number
9331|NCT02058160|Secondary|Change in 2-hour PPG From Baseline to Week 30|Change in PPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline PPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
9332|NCT02058160|Secondary|Change in FPG From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline FPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
9333|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
9334|NCT02058160|Secondary|Change in Daily Insulin Glargine Dose From Baseline to Week 30||Baseline, Week 30|mITT population. The analysis included scheduled measurements obtained up to the date of last injection of IMP. Here, number of participants analyzed= participants with insulin glargine dose assessment during study period.||Units (U)||Standard Error|Least Squares Mean
9335|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
9336|NCT02058160|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline 7-point SMPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
9337|NCT02058160|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.||kg||Standard Error|Least Squares Mean
12659|NCT01953328|Secondary|Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
9338|NCT02058160|Secondary|Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period. Missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
9339|NCT02058160|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30||Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.||percentage of participants|||Number
9340|NCT02058160|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.||percentage of HbA1c||Standard Error|Least Squares Mean
9341|NCT02058147|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not have been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk of injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.||percentage of participants|||Number
9342|NCT02058147|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.||percentage of participants|||Number
9343|NCT02058147|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.||Events per subject-year|||Number
9344|NCT02058147|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) was performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.||percentage of participants|||Number
9345|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication.|Baseline up to Week 30|mITT population. Participants without Week 30 value for HbA1c were counted as non-responders.||percentage of participants|||Number
9346|NCT02058147|Secondary|Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 2-hour PPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
9347|NCT02058147|Secondary|Average Daily Insulin Glargine Dose at Week 30|The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy.|Week 30|mITT population. Here, number of participants analyzed = participants with insulin glargine dose assessment during study period. Data of this endpoint was planned to be analyzed for Insulin Glargine/Lixisenatide FRC and Insulin glargine arms only, not for lixisenatide arm.||Units (U)||Standard Error|Least Squares Mean
9348|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
9349|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.||percentage of participants|||Number
9350|NCT02058147|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here,number of participants analyzed = participants with baseline and at least one post baseline 7-point SMPG assessment during study period.||mmol/L||Standard Deviation|Least Squares Mean
32660|NCT01560260|Secondary|Clinical Benefit Rate Defined as SD >= 9 Months, PR or CR||Up to 2 years||||||
9351|NCT02058147|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analysed = participants with baseline and at least one post-baseline FPG assessment during study period.||mmol/L||Standard Error|Least Squares Mean
9352|NCT02058147|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.||kg||Standard Error|Least Squares Mean
9353|NCT02058147|Secondary|Change in Plasma Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF).|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period.||mmol/L||Standard Error|Least Squares Mean
9354|NCT02058147|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30|Participants without Week 30 value for HbA1c were counted as non-responders.|Week 30|mITT population.||percentage of participants|||Number
9355|NCT02058147|Primary|Change in HbA1c From Baseline to Week 30|"Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine.~Change in HbA1c was calculated by subtracting baseline value from Week 30 value."|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.||percentage of hemoglobin||Standard Error|Least Squares Mean
9356|NCT02058069|Other Pre-specified|Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)|"The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes.~The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment."|Pre-Op, 3 Month Post Op [change assessed between the two time periods]|participants = knees.||units on a scale||Standard Deviation|Mean
9357|NCT02058069|Secondary|Radiographic Assessment of Post-operative Limb Alignment.|Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.|3 Month Post Op|Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes).||degrees||Standard Deviation|Mean
9358|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|3 Month Post Op|participants = knees.||intra-operative complications|||Number
9359|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.|participants = knees.||intra-operative complications|||Number
9360|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.|participants = knees.||intra-operative complications|||Number
9361|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2) - Overall|Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
9362|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2)|Terminal half-life (T1/2) of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
9376|NCT02057237|Primary|The Primary Endpoint is the Proportion of Patients Maintained on Mitotane After 12 Consecutive Weeks of Therapy. A Positive Outcome Would be Seeing 50% or More Patients Maintained on Therapy. Secondary Endpoint Include Proportion of Adverse Events||maintain 50% of the patients on Mitotane at the 12 week mark|As only 1 patient was accrued to this trial, no data analysis was performed.|||||
9363|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
9364|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
9365|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
9366|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
9367|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Full Range|Median
9368|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax)|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||hours||Full Range|Median
9369|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax) - Overall|Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
9370|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax)|Maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
9371|NCT02057835|Primary|Percentage of Participants With Drug Related Adverse Events|Percentage of participants with drug related adverse events (AEs)|From drug administration until 31 days after drug administration, 31 days|Treated set||Percentage of participants|||Number
9372|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 12 weeks after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.|||||
9373|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 7 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.|||||
9374|NCT02057276|Primary|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 3 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.|||||
9375|NCT02057237|Secondary|Prostate Specific Antigen (PSA) Response Rate|"Continue increase of serum PSA beyond 8 weeks indicate PSA progression. Response and progression will be primarily evaluated in this study using PSA response criteria from the Prostate Cancer Working Group 2. Criteria used to define response include: at least a 50% decline in PSA, confirmed by a second measurement ≥4 weeks later. PSA progression is defined by a >25% increase from baseline in patients whose PSA did not decrease, and of 50% from the nadir value in patients whose PSA decreased. This increase in PSA must be >5 ng/ml, and confirmed by a second measurement, at least 1 week later; PSA nadir is defined as the minimum PSA value that was confirmed by a second measurement.~PSA progression free survival is defined as the time between the randomization date and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first."|PSA progression free survival and excessive toxicity. Plan to keep the patients on Mitotane for atleast 8 weeks, despite increasing level of PSA as other trials shown early increase in PSA followed by a subsequent decline.||||||
9377|NCT02056834|Primary|Mean Time to Union|Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function|12 months|||months||Standard Deviation|Mean
9378|NCT02056834|Secondary|Lysholm Knee Scale|The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The survey was administered to subject at follow-up visits and comprises 8 subscales related to limp, support, stair climbing, squatting, walking, running and jumping as well as a question related to the atrophy of the thigh. The responses to these 8 questions are graded to provide a maximum result of 100 points.|12 months|||participants|||Number
9379|NCT02056834|Secondary|VAS Leg Pain Frequency|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain frequency was rated on a 100-mm visual analog scale where zero indicated no pain at all and 100 represented pain always.|12 months|||units on a scale||Standard Deviation|Mean
9380|NCT02056834|Secondary|VAS Leg Pain Intensity|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain intensity was rated on a 100-mm visual analog scale where zero indicated no pain at all, and 100 represented the worst possible pain.|12 months|||units on a scale||Standard Deviation|Mean
9381|NCT02056834|Secondary|SF-12 Short Form Health Survey Mental Composite Score (MCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and at follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months|||units on a scale||Standard Deviation|Mean
9382|NCT02056834|Secondary|SF-12 Short Form Health Survey Physical Composite Score (PCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and all follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months|||units on a scale||Standard Deviation|Mean
9383|NCT02056834|Secondary|Peri-operative Complications||12 months|||participants|||Number
9384|NCT02056834|Secondary|Extension Ability and Stability|"The following was assessed:~extension ability of the knee~stability of the knee in extension"|12 months|||participants|||Number
9385|NCT02056834|Secondary|Surgeon’s Satisfaction With the Product|Satisfaction with product was assessed by the surgeon post-operatively, where surgeons indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated absolutely unacceptable, while a score of 100 indicated very satisfying.|Post-surgery|||units on a scale||Standard Deviation|Mean
9386|NCT02056834|Secondary|Patient’s Satisfaction|Satisfaction with treatment was assessed by the subjects, where subjects indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|12 months|||units on a scale||Standard Deviation|Mean
9387|NCT02056834|Secondary|Anatomical Gradings Assessed Radiographically|"The following was assessed:~depression of knee joint: presence or absence~condylar widening (enlargement of the knee joint): presence or absence~angulation; valgus/varus (abnormal outward/inward turning of the knee): presence or absence"|12 months|||participants|||Number
9388|NCT02056834|Secondary|Total Range of Motion||12 months|||participants|||Number
9389|NCT02056834|Secondary|Patients Who Reached Full Weight Bearing||12 months|||participants|||Number
9390|NCT02056834|Secondary|Absorption Rate of Calcium Phosphate Cement|Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.|12 months|||percentage of absorption at 12 months||Standard Deviation|Mean
9391|NCT02056834|Primary|Articular Subsidence|Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators|12 months|||participants|||Number
9392|NCT02056834|Primary|Fracture Union|Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays|12 months|||participants|||Number
9393|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 24 hours (msec)|24 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9394|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 12 hours (msec)|12 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9395|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 8 hours (msec)|8 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9396|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 6 hours (msec)|6 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9397|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 4 hours (msec)|4 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9398|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 3 hours (msec)|3 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9399|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 2 hours (msec)|2 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9400|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour 30 min (msec)|1 hour 30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9401|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour (msec)|1 hour|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9402|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 30 minutes (msec)|30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set||msec|Participants|95% Confidence Interval|Least Squares Mean
9403|NCT02055430|Other Pre-specified|Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)|"age, site of stones, size of stones, degree of hydronephrosis~they were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week||||||
9404|NCT02055430|Secondary|The Number of Subsequent Interventions Needed for Clearance of Stones .|The number of subsequent interventions needed for clearance of stones after normalization of serum creatinine in relation to initial urinary drainage method using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure|6 months||||||
9405|NCT02055430|Primary|Complications of Each Drainage Method|"complications of initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure (mucosal complications, failure of insertion, slippage, fever and infection, hematuria, leakage)~complications were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week||||||
9406|NCT02055430|Primary|Period to Return to Normal Creatinine|"period required for normalization of serum creatinine after initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with obstructive calcular anuria and Acute Renal Failure~serum creatinine was compared to normal values in matched healthy children"|1 week|||days||Standard Deviation|Mean
9407|NCT02055404|Primary|Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)|"Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: N/A; Not visible; Slightly visible, not acceptable; Slightly visible, acceptable; Clearly visible; More visible than necessary. Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. Visibility of Rotation Mark is reported as the percentage of assessments rating the rotation mark as Clearly visible or Slightly visible, acceptable."|Day 1|The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.||Percentage of assessments|||Number
9408|NCT02054754|Other Pre-specified|Pharmacodynamic Biomarker Assessment|Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.|Pre-dose, 1, 6 and 24 hours post dose||||||
9409|NCT02054754|Secondary|Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose|Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.|Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose|||ng.h/mL||Standard Deviation|Mean
9410|NCT02054754|Primary|Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters|"Safety and tolerability based on the number of participants with adverse events. Assessment and comparison to baseline of the following:~Physical exam~Safety bloods and urinalysis~12-lead ECG~Vital signs"|Participants will be followed until follow up visit, 6-11 days after dosing|||participants|||Number
9411|NCT02054702|Secondary|Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score|The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||Units on a scale||95% Confidence Interval|Least Squares Mean
9412|NCT02054702|Secondary|Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score|"The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject’s quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 not well at all to 5 very well. The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant."|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||Units on a scale||95% Confidence Interval|Least Squares Mean
9413|NCT02054702|Secondary|Response Rate by Study Week|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||percentage of participants|||Number
9432|NCT02054325|Primary|Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.|Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.|Mean Percent of reticular vein disappearance two months after treatment|||% of Reticular Veins that Disappeared||Standard Deviation|Mean
9414|NCT02054702|Secondary|Mean Change in Clinical Global Impression–Improvement (CGI-I) Score at Week 6|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.||Units on a scale||Standard Deviation|Mean
9415|NCT02054702|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||Units on a scale||Standard Error|Least Squares Mean
9416|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
9417|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Identification Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
9418|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Detection Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
9419|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment.||z-score||Standard Error|Least Squares Mean
9450|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|11-12 weeks|Participants with usable data included in the results||Hours/day||Standard Deviation|Mean
9718|NCT02038075|Other Pre-specified|Structured Clinical Interview for DSM-IV, Axis I and II (SCID)|The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.|Intake||||||
9420|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery of Early Phase Battery Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
9421|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Composite Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.||z-score||Standard Error|Least Squares Mean
9422|NCT02054702|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a mixed model repeated measures (MMRM) analysis with an unstructured variance covariance structure.||Units on a scale||Standard Error|Least Squares Mean
9423|NCT02054481|Secondary|Time to Loss of PASI50 Response|Time to loss of PASI50 response.|From first drug administration until end of follow-up period, up to 48 weeks|FAS||Days||95% Confidence Interval|Median
9424|NCT02054481|Secondary|Achievement of sPGA Clear or Almost Clear at Week 12|"Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12.~sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe)."|Week 12|FAS||Percentage of participants||95% Confidence Interval|Number
9425|NCT02054481|Secondary|Percentage Change in PASI Score From Baseline at Week 12|"Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS including patients with available data.||Percentage of PASI score||Standard Deviation|Mean
9426|NCT02054481|Secondary|Achievement of PASI90 at Week 24|"Percentage of participants who achieved PASI90 at Week 24.~PASI score ranges from 0 (best) to 72 (worst)."|Week 24|FAS||Percentage of participants||95% Confidence Interval|Number
9427|NCT02054481|Secondary|Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12|"Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS||Percentage of participants||95% Confidence Interval|Number
9428|NCT02054481|Secondary|Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12|"Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS||Percentage of participants||95% Confidence Interval|Number
9429|NCT02054481|Secondary|Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24|"Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline, Week 12 and Week 24|FAS||Percentage of participants||95% Confidence Interval|Number
9430|NCT02054481|Primary|Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12|"Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|Full Analysis Set (FAS) which included all randomised patients who received at least 1 dose of trial medication and was based on the randomised treatment.||Percentage of participants||95% Confidence Interval|Number
9431|NCT02054325|Secondary|The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment|"Skin hyperpigmentation was defined as a brownish hue stain superimposing the previous treated vein site (by visual photographic analyses). Skin hyperpigmentation was firstly evaluated according to its occurence and labeled as Yes or No. Afterwards, when there was stain in the previous treated area, a line was drawn on the stain with Image J software , and the Mean Percent of Skin Hyperpigmentation was proportionaly compared with length of vein treated, previuos mesuread (mean and SD)."|Two months after treatment.|||Percent of Skin Hyperpigmentation||Standard Deviation|Mean
9451|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|5-6 weeks|Participants with usable data included in the results||Hours/day||Standard Deviation|Mean
9433|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.||unit on a scale||Standard Deviation|Mean
9434|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|The EORTC Quality of Life Questionnaire (QLQ-C30) was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.||unit on a scale||Standard Deviation|Mean
9435|NCT02053610|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants who were reported as not having started re-treatment or new anti−leukemic therapy were censored at the last visit date they were assessed with regard to start of new treatment or the date of death.||months||95% Confidence Interval|Median
9436|NCT02053610|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
9437|NCT02053610|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with response.||months||95% Confidence Interval|Median
9438|NCT02053610|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants who were not reported as having died at the time of the analysis were censored at the date when they were last known to be alive.||months||95% Confidence Interval|Median
9439|NCT02053610|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants were censored at the date of last tumor assessment. In cases where no tumor assessment is available, participants were censored at the date of randomization plus one day.||months||95% Confidence Interval|Median
9440|NCT02053610|Secondary|Percentage of Participants With Best Overall Response [Time Frame: Randomization to Clinical Cutoff (Median Observation 14.2 Months)]|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi, PR or nodular Partial Response (nPR). CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
9719|NCT02038075|Secondary|Beck Anxiety Inventory|The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.|24 months||||||
9441|NCT02053610|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. Complete Response (CR) required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. Partial Response (PR) required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
9442|NCT02053610|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff (median observation 14.2 months)|ITT participants included all randomized participants.||percentage of participants|||Number
9443|NCT02053610|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 18.8 months GClb and 18.6 months RClb)|Intent-to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.||months||95% Confidence Interval|Median
9444|NCT02053610|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants.||percentage of participants|||Number
9445|NCT02053610|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 39 months)|Intent--to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.||months||95% Confidence Interval|Median
9446|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|9-12 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
9447|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|3-6 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
9448|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|9-12 weeks|Participants with usable data included in the results||accelerometry units/day||Standard Deviation|Mean
9449|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|3-6 weeks|Participants with usable data included in the results||accelerometry units/day||Standard Deviation|Mean
9454|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase II)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|11-12 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
9455|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values.|Week 13|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
9456|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).|Week 7|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
9457|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 13|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
9458|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 7|Participants with usable data included in the results||units on a scale||Standard Deviation|Mean
9459|NCT02053493|Secondary|Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.|Self reported participant preference for study period 1 vs. study period 2.|Week 13|Participants with usable data included in the results||participants|||Number
9460|NCT02053493|Secondary|Six Minute Walk Distance (Phase II)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 13|Participants with usable data included in the results||meters||Standard Deviation|Mean
9461|NCT02053493|Secondary|Six Minute Walk Distance (Phase I)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 7|Participants with usable data included in the results||meters||Standard Deviation|Mean
9462|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase I)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|5-6 weeks|Participants with usable data included in the results||accelerometry units||Standard Deviation|Mean
9463|NCT02052895|Primary|Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis|For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.|Up to 7 days|Out of 196 Sepsis/SIRS patients, 6 were excluded due to inclusion/exclusion criteria violation and 4 were excluded due to insufficient data for Sepsis/SIRS adjudication||probability||95% Confidence Interval|Least Squares Mean
9464|NCT02052752|Secondary|To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Units on a scale||Standard Deviation|Mean
9465|NCT02052752|Secondary|To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Units on a scale||Standard Deviation|Mean
9466|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion’s diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion’s widest or highest points.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Percentage change||Standard Deviation|Mean
34563|NCT01528332|Secondary|Change From Baseline in VAS Pain Intensity at Follow up||Baseline (day -7 to 1) to Follow-up (up to day +42)||||||
9467|NCT02052752|Secondary|To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Units on a scale||Standard Deviation|Mean
9468|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion’s swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion’s highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant|Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Percentage change||Standard Deviation|Mean
9469|NCT02052752|Primary|To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.|The Investigator assessed and score each target lesion’s swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion’s highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure|Baseline to Day 4|The analysis population consists of the intent-to-treat (ITT) population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.||Percentage change||Standard Error|Mean
9470|NCT02052661|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
9471|NCT02052661|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0–30) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
9472|NCT02052661|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
9473|NCT02052661|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subject|||Number
9474|NCT02052661|Secondary|Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix™-B Kinder Vaccine.|The amnestic response to the challenge dose was defined as: for initially seronegative subjects, antibody concentration ≥ 10mIU/mL; for initially seropositive subjects, antibody concentration at least four times the pre-challenge antibody concentration.|One month after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subject|||Number
9475|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|1 month after the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subject|||Number
9476|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|Before the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix™ hexa during first two years of life, for whom the serological results were available.||Subject|||Number
9720|NCT02038075|Secondary|Beck Hopelessness Scale (BHS)|The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.|24 months||||||
9477|NCT02052661|Secondary|Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix™ Hexa.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.|Before (PRE) and 1 month after (POST) the single challenge dose of Engerix™-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix™ hexa during first two years of life, for whom the serological results were available.||mIU/mL||95% Confidence Interval|Geometric Mean
9478|NCT02052661|Primary|Anti-HBs Immune Response|Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.|One month after the single challenge dose of Engerix™-B Kinder vaccine (Month 1)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subject|||Number
9479|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose|PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|1 hour post loading dose|10 patients were included in the PD analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. Out of the 10 patients in the PD analysis, 1 patient in Ticagrelor group does not have PRU value at 1 hour post loading dose.||PRUs||Standard Deviation|Mean
9480|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose|PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|0.5 hours post loading dose|10 patients were included in the pharmacodynamic (PD) analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. 3 out 13 randomized pateints are excluded (1 patient without any PRU data, 2 pateints with protocol deviations)||PRUs||Standard Deviation|Mean
9481|NCT02052544|Primary|Overall Sensitivity and Specificity of Pefakit and Hemosil.|Sensitivity is the proportion of positive cases identified as positive. Specificity is the proportion of negative cases identified as negative. The Sensitivity and Specificity of Pefakit and Hemosil were calculated for the overall study population and separately for each of the three medical centers. Sensitivity and Specificity of Pefakit and Hemosil were each assessed relative to the reference method (Biophen)|within 2 - 4 days|AVS (all valid subjects) population: All valid subjects with no major deviation affecting outcome.413 samples total analyzed||percentage of cases||95% Confidence Interval|Number
9482|NCT02052414|Other Pre-specified|Patient Global Impression of Change (PGIC)|Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|15 Weeks.|||units on a scale||Standard Deviation|Mean
9483|NCT02052414|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status.|15 weeks.|FM patients who took study medication.||units on a scale||Standard Deviation|Mean
9484|NCT02052414|Secondary|Self Reported Side Effects.|Side / adverse effects were assessed at each follow up visits and resulted are as follows.|15 Weeks|Subject who experienced pain, acute delirium, symptoms related to adhesions due to prior surgical procedures, extremity swelling, and possible drug interactions discontinued medications. Other reported side effects dissipated after subjects reached therapeutic dose of 1800mg of study medication taken at bedtime.||participants|||Number
9485|NCT02052414|Secondary|Medical Outcome Study (MOS) Sleep Questionnaires|"Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas.~Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5)."|15 weeks|||Hours||Standard Error|Mean
9486|NCT02052414|Primary|Numeric Pain Rating System (NPRS)|Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable).|15 weeks|All subjects had diagnosis of fibromyalgia and met the inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
9487|NCT02051790|Primary|Agreement Between Expert Panel and Clinical Practice Reads|Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.|Scan acquired 50-60 minutes post injection|||Weighted Kappa statistic||95% Confidence Interval|Number
9488|NCT02051595|Primary|Circulating Vancomycin Concentration|Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.|Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)|||µg/mL||Standard Deviation|Mean
9507|NCT02050048|Primary|Development of Post-ERCP Pancreatitis|Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.|Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure|||participants|||Number
9508|NCT02049931|Secondary|the Progression of Body Compression Ratio Over All Follow-up Assessments||at the initial enrollment, 2 weeks, 6 weeks, and 12 weeks after compression fracture||||||
9489|NCT02051426|Primary|Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours|RAVLT measures short term verbal memory, verbal learning, susceptibility to (proactive and retroactive) interference, retention of information after a certain period of time during which other activities are performed and recognition memory. The test consists of a list of 15 common nouns, which are read to the subject in five consecutive trials (trials 1 through 5); each reading is followed by a free-recall task. In trial 6, an interface list of 15 new common nouns is presented, followed by free recall of these new nouns. In trial 7, without additional reading, subjects are again asked to recall the first list. Twenty minutes later, without an additional reading, subjects are asked to recall once more the first list (trial 8). The RAVLT score range from 0-90 correctly recalled words. For trial 7 the score ranges from 0 to 15 correctly recalled words.|Baseline, 2 hours post intervention|||units on a scale||Standard Deviation|Mean
9490|NCT02051426|Primary|Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours|"The d-prime score is a score given to each participant on a scale of 0.0 - 1.0 in which discrimination sensitivity is measured. A score of 0 equates to no sensitivity whereas a score of 1.0 equates to perfect sensitivity."|Baseline, 2 hours post intervention|||units on a scale||Standard Deviation|Mean
9491|NCT02051426|Primary|Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours|The subject was asked to point on the VAS scale according to his anxiety level. VAS anxiety scale 0 to 10 ( 0 [no anxiety] to 10 [maximum anxiety] ).|Baseline, 2 hours post intervention|||units on a scale||Standard Deviation|Mean
9492|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-Dose|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan=abnormal clinically significant.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
9493|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
9494|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis. LLN=lower limit of normal. ULN=upper limit of normal.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
9495|NCT02051335|Secondary|Percentage of Participants Who Experience at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any adverse event, regardless of relationship to study drug that occurs or worsens after the first dose of study drug and no more than 14 days after the last dose of study drug.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.||percentage of participants|||Number
9496|NCT02051335|Secondary|Change From Baseline in the Spatial Working Memory (SWM) Total Number of Between Errors at the 10-Box Stage and the 12-Box Stage at All Time-points Assessed After Scopolamine Administration|SWM assesses the ability to retain spatial information and manipulate it in working memory. In this task, colored boxes are shown on the screen, and participants must search for blue tokens by touching the colored boxes to open them. When the blue token has been found the participant has to place the token in the black column (‘home’) on the right-hand side of the screen by touching this area. The participant must not return to a box where a token has previously been found. The task becomes more difficult as the number of boxes increases (one trial at each of 6-box and 8-box stages; three trials at each of 10-box and 12-box stages). Between Errors is the total number of times the participant revisits a box in which a token has previously been found in the same problem. The possible range of errors is 0 (best) to 1040 (worst). Lower number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||errors||Standard Deviation|Mean
9497|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) Median Latency at All Time-points Assessed After Scopolamine Administration|RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. Assessment will be based on a median latency. The possible range for RVP median latency is 100 (worst) to 1900 (best). Higher number in the test indicates a better outcome. “Median latency” is a measure captured by computerized test measure and given as “one” time value (between 100 and 1900). The “mean” of these values is presented.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||msec||Standard Deviation|Mean
9509|NCT02049931|Secondary|General Health Status|The general health status was assessed with use of the Short Form-36 (SF-36) at the initial enrollment and 12 weeks after compression fracture.|at the initial enrollment and 12 weeks after compression fracture||||||
9510|NCT02049931|Secondary|Oswestry Disability Index (ODI)||at 2 weeks, 6 weeks, and 12 weeks after compression fracture.||||||
9511|NCT02049931|Secondary|Visual Analog Pain Scale (VAS) for Back Pain|The VAS for back pain comprised a 10-cm line with “none” (0) on one end and “disabled pain” (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.|2 weeks, 6 weeks, 12 weeks after injury||||||
9498|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) A Prime Signal Detection at All Time-points Assessed After Scopolamine Administration|RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. A prime (A′) is a signal detection measure that reflects target sensitivity regardless of the participant’s tendency, or bias, to respond. Detection sensitivity for RVP A’ prime: 0 to 1. Lower numbers in the test indicates worsening in the performance.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||unitless||Standard Deviation|Mean
9499|NCT02051335|Secondary|Change From Baseline in the Paired Associates Learning (PAL) Total Number of Errors Adjusted at All Time-points Assessed After Scopolamine Administration|PAL assesses visuospatial associative learning and memory. Boxes are displayed on the screen and open in a randomised order to reveal a number of patterns. The patterns are then displayed in the middle of the screen, one at a time, and the participant must touch the box where the pattern was originally located. If the participant makes an error, the patterns are re-presented to remind the participant of their locations. If the participant has not responded correctly within six attempts, ie, one presentation and five re-presentations, the task is terminated. As the task progresses the difficulty level increases with the number of patterns to be remembered. For participants who fail to complete all levels, an adjusted total is calculated that takes into account errors predicted in the stages that were not attempted. The possible range for total errors is 0 (best) to 91 (worst). Fewer number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||errors||Standard Deviation|Mean
9500|NCT02051335|Secondary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate and Delayed Recall at 2 and 4 Hours After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||correct responses||Standard Deviation|Mean
9501|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.||correct responses||Standard Deviation|Mean
9502|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Delayed Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period. Baseline is defined as the assessment 1 hour before roflumilast/donepezil administration (3 hours before scopolamine administration).|Participants from the Full Analysis Set with data available for analysis at the given time-point.||correct responses||Standard Deviation|Mean
9503|NCT02050334|Secondary|Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.||hours||Standard Error|Mean
9504|NCT02050334|Secondary|Pharmacokinetics (PK)|Time to Reach Maximum Observed Plasma Concentration (Tmax)|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.||hours||Standard Error|Mean
9505|NCT02050334|Primary|Unsolicited Adverse Event Reports|Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.|Minimum of 24 hours after each dose.|All 18 subjects analyzed, per protocol.||Unsolicited Adverse Event Reports|||Number
9506|NCT02050048|Secondary|Number of Participants With Adverse Events Related to Fluid Overload|A portion of the study will assess whether there is a significant risk of adverse events related to fluid overload states in the high volume (HV) intervention arm. We anticipate the rate of adverse events in patients randomized to the HV arm to be small. By using more modest, weight based regimens, we aim to optimize benefit while eliminating overly aggressive fluid administration and causing undue harm.|Phase II portion (~1 year)||||||
9512|NCT02049931|Primary|Oswestry Disability Index (ODI) at 12 Weeks|The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).|12 weeks after injury|||units on a scale||95% Confidence Interval|Mean
9513|NCT02048891|Secondary|Patients Comfort During the Luteal Phase||During 2 weeks from day of oocyte retrieval||||||
9514|NCT02048891|Primary|Fetal Heart Activity 1 Month After Oocyte Retrieval|Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval|1 month after oocyte retrieval|||participants with fetal heart activity|||Number
9515|NCT02048072|Primary|RMSSD Normal Breathing|"Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR or pulse intervals.~It is calculated as the square root of the mean of the squares of the successive differences between adjacent RR intervals or pulse intervals.~In this study pulse intervals were measured non-invasively during five minutes, while subjects were supine, breathing regularly.~Measurements were done at two timepoints t=0 and t=4,5hours. RMSSD was compared between these two timepoints."|t-4,5 hours|||milliseconds||95% Confidence Interval|Mean
9516|NCT02047747|Secondary|Treatment-emergent Adverse Events||End of Treatment (4-6 weeks after permanent discontinuation of study treatment for any reason)|The study was terminated due to slow enrollment. Please see adverse event section for additional information.|||||
9517|NCT02047747|Primary|Intra-cranial Objective Response Rate|Intra-cranial objective response rate at 2 months as assessed by the Response Assessment in Neuro-oncology (RANO) criteria|2 months|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data not available.|||||
9518|NCT02047227|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.|15 to 20 days post r-hCG administration (Day 132)|MITT Analysis Set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
9519|NCT02047227|Secondary|Clinical Pregnancy Rate|Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.|35-42 days post r-hCG administration (Day 154)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
9520|NCT02047227|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|35-42 days post r-hCG administration (Day 154)|"MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."||percent sacs per embryo|||Number
9521|NCT02047227|Secondary|Live Birth Rate|Live birth rate was defined as the percentage of subjects with at least one live-born neonate.|Approximately 180 days following ongoing pregnancy determination (Day 365)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
9522|NCT02047227|Secondary|Ongoing Pregnancy Rate|Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).|70 days after embryo transfer (Day 185)|Modified intent-to-treat (MITT) analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.||percentage of subjects|||Number
9523|NCT02047227|Primary|Number of Oocytes Retrieved|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|At approximately 34 to 38 hours after r-hCG administration (Day 113)|Intent-to-treat (ITT) analysis set included all subjects randomized who received at least 1 dose of GONAL-f or Pergoveris.||oocytes||Standard Deviation|Mean
9524|NCT02046993|Primary|Comparison Between Mean Home Systolic and Diastolic Blood Pressure HSBP and HDBP Readings at 6 Months Between the Smartphone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|6 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected||mmHg||Standard Deviation|Mean
9525|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings at 3 Months Between Smart Phone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|3 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected||mmHg||Standard Deviation|Mean
9526|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|baseline|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected||mmHg||Standard Deviation|Mean
9527|NCT02046993|Secondary|Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention|This is a 6-items scale for measuring confidence of patients in self management of their chronic disease. Each item has a likert scale from 1 to 10 with 10 as most confident. Higher score indicating higher self-efficacy|6 months|||units on a scale||Standard Deviation|Mean
9528|NCT02046993|Primary|Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline|At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will meaure blood pressure after 15 minutes rest with validated electronic automated sphygmanometer ( ) . Four blood pressure readings taken at 1 minute interval will done for each subject and the mean of the second and third reading would be used for the primary outcome ,|baseline, 3rd month and 6 month|Intention to treat analysis was used and the last known data were carried forward to replace missing values for drop-outs.||mmHg||Standard Deviation|Mean
9529|NCT02046993|Primary|Percentage of Subjects Doing Home BP Monitoring|Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week|Baseline, 3rd month, 6th month|||percentage of subjects doing HBPM|||Number
9530|NCT02046980|Primary|Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus||2 days|217 patients enrolled in the study but 8 retracted their agreements.||participants|||Number
9531|NCT02046863|Primary|Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming|Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.|Within two days of standard clinical DBS programming session|||Percentage change||Standard Deviation|Mean
9532|NCT02046772|Secondary|Time of Hospitalization|To see if the hospitalization time is shortened or not by the experimental treatment.|Up to 72 hours after the intervention|||participants|||Number
9533|NCT02046772|Secondary|Number of Adverse Events|To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.|Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge|||participants|||Number
9534|NCT02046772|Secondary|Greater and Earlier Mobilization Measured by Bromage Scale.|"To assess whether the administration of morphine chloride in addition to a low dose solution of local intradural anaesthetic (bupivacaine) improves the mobilization of the patients after surgery more than the single intradural administration of bupivacaine.~Total Score in the Bromage Scale goes from 1 to 5, where:~1: complete motor blocking - 2: capable to move the feet - 3: moves the feet and bends the knee - 4: raise the leg straight more or less than 30 degrees but no against resistance - 5: raise the leg straight more than 30 degrees against resistance (no motor blocking)"|During the first 24 hours after surgery and at the entry and exit of the resuscitation unit|||units on a scale||Standard Deviation|Mean
9535|NCT02046772|Primary|Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.|To compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.|Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge|||units on a scale||Standard Deviation|Mean
9536|NCT02046772|Primary|Measurement of Time to Start the Anaesthetic Effect|To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.|First 20 minutes between administration and beginning of surgery|||minutes||Standard Deviation|Mean
9537|NCT02046226|Secondary|Incidence of Complete Wound Closure|number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks.|3 months|Study subjects were not available to provide data when the secondary outcome was to be reported, and thus there are no secondary outcome data to report.|||||
9538|NCT02046226|Primary|Rate of Wound Healing|Percentage reduction in target wound area (length x width).|3 months|Study subjects were not available to provide data when the primary outcome was to be reported, and thus there are no primary outcome data to report.|||||
9539|NCT02045732|Secondary|Concentration of PF-06342674||Baseline through Day 127/Early Termination|Participants in the placebo arm did not receive PF-06342674. Due to the early termination of the study, the small enrollment number and minimal data, concentration data were listed but not summarized, and pharmacokinetic (PK) parameters were not calculated for the PF-06342674 0.25 mg/kg arm.||nanogram/milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
9540|NCT02045732|Primary|Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)|Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32.|Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
20610|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
9541|NCT02045732|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug. The QTcF interval of the participant in the placebo arm was in this range of 450 to <480 msec at Baseline. This participant experienced a decrease in QTcF of 30 to <60 msec on Day 30, which then returned to baseline levels on Day 57.||participants|||Number
9542|NCT02045732|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
9543|NCT02045732|Primary|Number of Participants With Clinical Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
9544|NCT02045732|Primary|Number of Treatment-Emergent AEs and SAEs by Severity|AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||adverse events|||Number
9545|NCT02045732|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.||participants|||Number
9546|NCT02045264|Secondary|Change From Baseline in Pulse Rate||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||beats per minute||Standard Deviation|Mean
9547|NCT02045264|Secondary|Change From Baseline in Systolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||mmHg||Standard Deviation|Mean
9548|NCT02045264|Secondary|Change From Baseline in Diastolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||mmHg||Standard Deviation|Mean
9549|NCT02045264|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Icatibant and Metabolites|AUC0-t is the area under the plasma concentration versus time curve extrapolated from time 0 to to the last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
9550|NCT02045264|Secondary|Safety Evaluation Measured by Percentage of Subjects With Not Clinically Significant Abnormalities in ECG Results||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||percentage of participants|||Number
9551|NCT02045264|Secondary|The Percentage of Subjects With Any Injection Site Reactions.||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||percentage of participants|||Number
9552|NCT02045264|Secondary|The Total Number of Treatment-Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were those that started after the single dose of icatibant.|TEAEs were collected after the single dose of icatibant until follow up, 5-7 days after icatibant administration|The Safety Set consisted of all subjects who had taken the single dose of icatibant.||Treatment Emergent Adverse Events|||Number
9553|NCT02045264|Primary|Total Body Clearance (CL/F) of Icatibant|The rate at which a drug is removed from the body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||mL/hr||Standard Deviation|Mean
9554|NCT02045264|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Icatibant and Metabolites|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
9555|NCT02045264|Primary|Drug Concentration Half-Life (T1/2) of Icatibant and Metabolites|The time it takes for the blood plasma concentration of a substance to halve.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||hr||Standard Deviation|Mean
40753|NCT01445951|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point glucose at baseline|Baseline|Full analysis set||mg/dL||Standard Deviation|Mean
9556|NCT02045264|Primary|Time to Peak Plasma Concentration (Tmax) of Icatibant and Metabolites|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||hr||Standard Deviation|Mean
9557|NCT02045264|Primary|Peak Plasma Concentration (Cmax) of Icatibant and Metabolites|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
9558|NCT02045238|Secondary|Incidence of Adverse Effects|Any adverse effects directly attributable to treatment shall be noted. Mere lack of improve or worsening of symptoms attributable to the disease clinical course will not be considered as adverse effects.|24 hours|Number of patients too small to achieve statistical significance||participants|||Number
9559|NCT02045238|Secondary|Rate of Readmission After Discharge|The mere attendance to the Emergency Department will not be isolately considered, as it may be due to a scheduled reevaluation.|5 days||||||
9560|NCT02045238|Secondary|Time to Discharge|Actual time to discharge was considered of secondary importance as it can be influenced by individual considerations like patient age or time of the day.|24 hours||||||
9561|NCT02045238|Primary|Time to Attain Discharge Criteria|Discharge criteria are: Room air saturation >94% AND respiratory rate < 60 AND Respiratory Distress Assessment Instrument (RDAI) score inferior than 4, maintained over a 4 hour period.|24 hours||||||
9562|NCT02045238|Primary|Rate of Admission|Patients staying longer than 24h are considered to be admitted to ward.|24 hours|Number of participants analyzed was too small to obtain statistic significance||participants|||Number
9563|NCT02044848|Primary|Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test|Study was terminated and no data were collected for the Outcome Measure.|Week 52|Study was terminated and no data were collected for the Outcome Measure|||||
9564|NCT02044458|Other Pre-specified|Failure Rates of the Placement of a Foley Catheter|To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette|Followed throughout patient's hospital stay, approximately 10 days|||failed attempt|||Number
9565|NCT02044458|Secondary|Pain Assessed by Visual Analog Scale (VAS)|To compare the pain assessed by visual analogue scale(VAS), in women randomly allocated to ridged stylette or no ridged stylette. Patient-assessed pain level was determined by verbally asking patients to assess their pain (on a scale from 0-10 [no pain-worst pain]) following taping of the catheter tail. Pain was only assessed once.|Followed throughout patient's hospital stay, approximately 10 days|The pain level of one successful attempt with stylette was not recorded.||units on a scale||95% Confidence Interval|Mean
9566|NCT02044458|Primary|Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.|Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).|Followed throughout patient's hospital stay, approximately 10 days|The insertion time of two failed attempts with no stylette were not recorded.||minutes||Inter-Quartile Range|Median
9567|NCT02044393|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)|AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity).|from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
9568|NCT02044393|Primary|Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)|Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).|From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
9569|NCT02044393|Primary|AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)|AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.|from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|Pharmacokinetic Set (PKS): included all subjects from the TS who provided at least one primary or secondary pharmacokinetic endpoint in any period that is judged as evaluable for pharmacokinetics and is not affected by protocol violations relevant to the statistical evaluation of bioavailability||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
9570|NCT02044367|Secondary|Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Palatability question: How do you rank the taste? with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.||participants|||Number
9571|NCT02044367|Secondary|Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Acceptability question: Would you accept to take this medication for chronic use? with 3 possible answers: Yes - No - I am not sure."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.||participants|||Number
12660|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
9572|NCT02044367|Secondary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9573|NCT02044367|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
9574|NCT02044367|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9575|NCT02044367|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
9576|NCT02043808|Secondary|Death|"Event rate of death, due to any cause.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9577|NCT02043808|Secondary|Pulmonary Embolism|"Event rate of pulmonary embolism.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9578|NCT02043808|Secondary|Deep Vein Thrombosis|"Event rate of deep vein thrombosis.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9579|NCT02043808|Secondary|Venous Thromboembolism|"Event rate of venous thromboembolism.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9580|NCT02043808|Secondary|Myocardial Infarction|"Event rate of myocardial infarction.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9581|NCT02043808|Secondary|Transient Ischemic Attack|"Event rate of transient ischemic attacks.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9582|NCT02043808|Secondary|Major Other Bleeding|"Event rate of major other bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9583|NCT02043808|Secondary|Major Urogenital Bleeding|"Event rate of major urogenital bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9584|NCT02043808|Secondary|Major Lower GI Bleeding|"Event rate of major lower gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9585|NCT02043808|Secondary|Major Upper GI Bleeding|"Event rate of major upper gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
10678|NCT02007434|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and Day 84|Safety analysis set with available data at both time points||mm||Standard Deviation|Mean
9586|NCT02043808|Secondary|Major GI Bleeding|"Event rate of major gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9587|NCT02043808|Secondary|Major Extracranial Bleeding|"Event rate of major extracranial bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9588|NCT02043808|Secondary|Major Intracranial Bleeding|"Event rate of major intracranial bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9589|NCT02043808|Secondary|Hemorrhagic Stroke|"Event rate of hemorrhagic stroke.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9590|NCT02043808|Secondary|Ischemic Stroke|"Event rate of ischemic stroke.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9591|NCT02043808|Primary|Major Bleeding|"Event rate of major bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9592|NCT02043808|Primary|Stroke (Hemorrhagic, Ischemic)|"Event rate of stroke (hemorrhagic, ischemic).~Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65–74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort||Events per 1000 person-years||95% Confidence Interval|Number
9593|NCT02043782|Primary|Degree of Leakage|The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.|14 +/- 3 days|||units on a scale|Participants|Standard Deviation|Mean
9594|NCT02043366|Secondary|Normalized Area of Hyperalgesia Around the Incision|The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a ‘painful’, ‘sore’ or ‘sharper’ feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.|24 hours after surgery|||cm^2||Standard Deviation|Mean
9595|NCT02043366|Secondary|Cumulative Sufentanyl Consumption|Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively|24 hours||||||
9596|NCT02043366|Secondary|Total Dose of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour after surgery||||||
9597|NCT02043366|Secondary|Occurrence of Side Effects|Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus|24 hours||||||
9598|NCT02043366|Secondary|Time of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour post surgery||||||
9599|NCT02043366|Secondary|Pain Score (NRS)|The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.|3h, 6h, 12h, and 24h after surgery||||||
9600|NCT02043366|Primary|Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm|The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively|24 hours after surgery|||g||Standard Deviation|Mean
9601|NCT02043145|Primary|Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale|The Investigator assessed the severity of the patient’s glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.||score on a scale||Standard Deviation|Mean
9629|NCT02041520|Secondary|Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM||95% Confidence Interval|Mean
9602|NCT02043145|Primary|Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale|The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.||score on a scale||Standard Deviation|Mean
9603|NCT02043145|Primary|Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale|Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.||score on a scale||Standard Deviation|Mean
9604|NCT02043145|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)|An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event.|4 Years|Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.||participants|||Number
9605|NCT02042911|Secondary|Number of Subjects With Clinically Significant Physical Examination Values|Number of subjects with abnormal or severe values of vital signs, electrocardiogram, and physical examination including ECOG performance status|Up to 30 months|||participants|||Number
9606|NCT02042911|Secondary|Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to adverse event|Up to 30 months|||participants|||Number
9607|NCT02042911|Secondary|Adverse Events|All undesirable medical events experienced by the subject treated with the investigational product (including abnormal changes in laboratory values) are treated as adverse events and evaluated for safety.|Up to 30 months|||participants|||Number
9608|NCT02042911|Secondary|Overall Survival (OS)|The period from the date of patient registration to the date of death.|Up to 30 months|||months||95% Confidence Interval|Median
9609|NCT02042911|Secondary|Duration of Remission|The period from the day of CR or PR confirmation to recurrence/relapse.|Up to 30 months|||months||95% Confidence Interval|Median
9610|NCT02042911|Secondary|Progression-free Survival (PFS)|The period from the first day of the study drug administration (Day1) to progressive disease (PD), recurrence/relapse, or death.|Up to 30 months|||months||95% Confidence Interval|Median
9611|NCT02042911|Secondary|Complete Remission Rate (CR+CRi) Based on IWCLL Guideline||Up to 30 months|||Percentage of participants||95% Confidence Interval|Number
9612|NCT02042911|Secondary|National Cancer Institute-sponsored Working Group (NCI-WG) Response Rate (CR+nPR+PR) Based on IWCLL Guideline|"The criteria for nPR and PR based on IWCLL guideline are shown below.~nPR: Fulfills all CR criteria other than residual lymphoid nodules confirmed by bone marrow examination.~PR: Fulfills two or more items from Group A and one or more items from Group B for a minimal duration of 8 weeks.~Group A;~50% or greater reduction in lymphocyte count in peripheral blood from baseline~50% or greater reduction (size reduction) in Sum of the products of the greatest diameters (SPD) and no new lesion emergence or no new enlarged lymph node~A decrease in the size of the liver and/or spleen by 50% more~A decrease in marrow infiltration or lymphoid nodules by 50% more Group B;~1) Neutrophil count ＞1.5×10^9/L or 50% improvement from baseline 2) Platelet count ＞100×10^9/L or 50% improvement from baseline 3) Hemoglobin 11.0 g/dL or 50% improvement from baseline without transfusions"|Up to 30 months|||Percentage of participants||95% Confidence Interval|Number
9613|NCT02042911|Primary|Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline|"The criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR).~CR: Assessment should be made at least 8 weeks after completion of administration.~Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter)~No hepatomegaly or splenomegaly~Absence of B symptoms~Meet the following laboratory test values;~lymphocyte count in peripheral blood: ＜4.0×10^9/L~neutrophil count: ＞1.5×10^9/L~platelet count: 100×10^9/L~hemoglobin: 11.0 g/dL without transfusions~less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules).~No new lesion emergence~CRi: Fulfills all of the following criteria~Delayed anemia, thrombocytopenia, or neutropenia is observed.~Fulfills all CR criteria other than 4).~Delayed symptoms are all judged to be caused by drug."|Up to 30 months|||Percentage of participants||95% Confidence Interval|Number
9614|NCT02042872|Secondary|Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the total hip.|Baseline and 12 months|||g/cm2||Standard Deviation|Mean
12661|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
9615|NCT02042872|Primary|Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the distal femur and proximal tibia by using a customized research software program supplied by the manufacturer. This measurement will be the primary determinant (dependent measure) of difference among the treatment and control groups, and they will be followed over time at the previously specified time points.|Baseline and 12 months|||g/cm2||Standard Deviation|Mean
9616|NCT02042534|Secondary|Number of Participants With Modified Rankin Score of 0 or 1 at Week 4|"modified Rankin Score~0 : No symptoms at all~: No significant disability despite symptoms; able to carry out all usual duties and activities~: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~: Moderate disability; requiring some help, but able to walk without assistance~: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~: Severe disability; bedridden, incontinent and requiring constant nursing care and attention~: Dead"|at 1 month|Modified ITT (mRS 0,1 at Week 4, n(%)||participants|||Number
9617|NCT02042534|Secondary|Length of Hospitalization|Time to event will be calculated|at 1month|||days||Standard Deviation|Mean
9618|NCT02042534|Secondary|The Number of Patients With Recurrent Ischemic Lesion|Recurrent ischemic lesion confirmed by relevant neuroimagings|at 1 month|Modified ITT||Participants|||Number
9619|NCT02042534|Secondary|The Number of Patients With Intracranial Bleeding|Intracranial bleeding confirmed by relevant neuroimagings|at 1 month|Modified ITT||Participants|||Number
9620|NCT02042534|Primary|Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging|"Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month~Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 1 month"|1 month after randomization|"modified Intention to treat: 95 / 88 (Rivaroxaban/Warfarin)~Per protocol: 93 / 87 (Rivaroxaban/Warfarin)~Safety: 98 / 90 (Rivaroxaban/Warfarin)"||Participants|||Number
9621|NCT02042404|Other Pre-specified|Determine the Incidence of Serious Device- and Procedure-related Adverse Events.|The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.|120 days|Both Primary Cohort and Roll-in Cohort were included in all safety analyses.||serious device- or procedure-related AEs|||Number
9622|NCT02042404|Secondary|Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.|Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.||dB difference in HINT scores||Standard Deviation|Mean
9623|NCT02042404|Secondary|Functional Gain Over the Frequency Range From 2000 to 10,000 Hz|10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.||dB difference in Soundfield Hearing||Standard Deviation|Mean
9624|NCT02042404|Primary|Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment|"The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of No Hearing Change for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less."|Baseline and 120 days|43 subjects available for analysis between enrollment/treatment and 120 day measurement.||dB difference in Unaided Hearing||Standard Deviation|Mean
9625|NCT02042404|Primary|Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.|Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.||percentage of words correctly identified||Standard Deviation|Mean
9626|NCT02041520|Secondary|Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||UI/L||95% Confidence Interval|Mean
9627|NCT02041520|Secondary|Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||UI/L||95% Confidence Interval|Mean
9628|NCT02041520|Secondary|Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||µM||95% Confidence Interval|Mean
9633|NCT02041520|Primary|Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value|||nM/mg protein||95% Confidence Interval|Mean
9634|NCT02041377|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour|||participants|||Number
9635|NCT02041377|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|133 (134-1) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol.||Blood glucose results|||Number
9636|NCT02041377|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|129 (134-5) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had low blood sugar and AST result was not evaluable per protocol. One subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.||Blood glucose results|||Number
9637|NCT02041377|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|131 (134-3) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.||Blood glucose results|||Number
9638|NCT02041377|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|132 (134-2)Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had no fingerstick result.||Blood glucose results|||Number
9639|NCT02041325|Secondary|Phenotypic Changes|Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.|6 weeks|||cells/cmm||Full Range|Median
9640|NCT02041325|Secondary|Quantity of Subjects With a T-cell Response|Participants who displayed a T cell responses against HbSAg following vaccination|6 weeks|||participants|||Number
9641|NCT02041325|Secondary|Safety|Number of participants with adverse events as a measure of safety and tolerability|6 weeks|||participants|||Number
9642|NCT02041325|Primary|Positive for Hepatitis B Surface Antigen|The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).|6 weeks|||participants|||Number
9643|NCT02041286|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour|||participants|||Number
9644|NCT02041286|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE.||Blood glucose results|||Number
9645|NCT02041286|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|130 (136-6) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for one (1) subject. Three (3) subjects had low blood sugar; AST results were not evaluable per protocol.||Blood glucose results|||Number
9721|NCT02038075|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.|24 months||||||
9646|NCT02041286|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|132 (136-4) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject lab reference replicates were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.||Blood glucose results|||Number
9647|NCT02041286|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available.||Blood glucose results|||Number
9648|NCT02041221|Primary|Number of Subjects With Adverse Events|The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients|Two (2) Weeks|||participants|||Number
9649|NCT02040792|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)||Baseline to 28 days|||mL||Standard Error|Least Squares Mean
9650|NCT02040623|Primary|Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.|Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.|Baseline to 12 weeks|The per-protocol (PP) population excludes subjects with significant protocol deviations or with early study termination||units on a scale||Standard Deviation|Mean
9651|NCT02039817|Primary|Cmax|Maximum concentration (Cmax)|48 hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9652|NCT02039817|Secondary|Levels of cCK18|Biomarker cCK18 (Cleaved cytokeratin 18) PK evaluations from pre-dose to 48 hours|48 hours|||U/L||Inter-Quartile Range|Median
9653|NCT02039817|Primary|AUC|Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast|48 hours|7 subjects were used in the calculation of AUC0-inf for the healthy volunteer group as one subject had no identifiable terminal log-linear phase.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
9654|NCT02039687|Secondary|• Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters||16 weeks||||||
9655|NCT02039687|Secondary|• Change in the Scores of the Small Fiber Neuropathy Screening List, BPI, NPSI, RAND-36, and FAS Questionnaires|Patient reported pain level, function, and quality of life questionnaires|16 weeks||||||
9656|NCT02039687|Secondary|Change in Intra-epidermal Nerve Fiber Density (IENFD)|Measurement of small fiber density in skin biopsies. Density is reduced in sarcoidosis patients, an indication of neuropathy.|28 days|||fibers/mm||Standard Deviation|Mean
9657|NCT02039687|Secondary|Change in the 6 Minute Walk Test|Measurement of the distance a patient can walk in 6 minutes|28 days|||meters||Standard Deviation|Mean
9658|NCT02039687|Primary|Change in Corneal Nerve Fiber Area|Measurement of corneal nerve fiber area is a non-invasive procedure performed at baseline and at the end of dosing and at 12 weeks follow-up. The nerve fiber area in sarcoidosis patients is reduced compared to normal humans, a measurement of small fiber loss.|28 days|||µm2||Standard Deviation|Mean
9659|NCT02039414|Secondary|Maternal Lipid Oxidation|The investigators will measure maternal lipid oxidation rate using indirect calorimetry (True One 2400, Parvo Medics, Sandy, UT) before, during, and after acute exercise. This will involve placing a hoodlike device over the subject's head as they lay supine (rest).During exercise, this involved using a mouthpiece and noseclips. Using both techniques, The investigators will be able to calculate lipid oxidation rates from the volumes of CO2 produced and volumes of O2 used.The reported measure is lipid oxidation rate during exercise. The equation used to calculate lipid oxidation is: lipid oxidation (g/min) = 1.695 VO2- 1.701 VCO2 .|Visit 2 (32-37 weeks gestation)- reported lipid oxidation is the average of lipid oxidation over the course of the 30min exercise bout (i.e. data collected at minutes 8-10, minutes 18-20, and minutes 28-30 of exercise, all averaged together).|Of the 40 women consented, only 32 (16 per group) completed all study visits and have lipid oxidation data.||g/min||Standard Deviation|Mean
9660|NCT02039414|Secondary|Maternal Inflammation|High-Sensitivity C-reactive protein was measured.|This was taken while fasted and under resting conditions at the beginning of visit 2 (between 32 and 37 weeks gestation). This value was only measured at baseline (i.e. one timepoint).|Of the 40 women consented, only 32 (16 in each group, completed the study visits). Thus, these 32 have CRP data.||mg/L||Standard Deviation|Mean
9661|NCT02039414|Primary|Neonatal Insulin Resistance|Infant HOMA-IR will be determined by measuring umbilical cord plasma glucose and insulin concentrations at parturition vis cord blood collection. Cord blood will be collected within 30 min of delivery, centrifuged for 10 min at 3000rpm to remove plasma, and stored at -80.|Immediately after delivery|We could not obtain cord blood on all infants (thus, specimens were obtained fro 14 obese active and 12 obese inactive women). Due to medical emergencies or lack-of cord blood available, there were several instances where these specimens could not be obtained by the study team.||HOMA_IR, unitless measure||Standard Deviation|Mean
9662|NCT02039414|Primary|Neonatal Adiposity|Within 48 hours of delivery, neonatal body composition (% fat mass) will be measured by skin fold thickness measurement and by air displacement plethysmography (Pea Pod, Life Measurement, Inc., Concord, CA) in the CRU at WUSM.|24-48 hr after delivery|Several babies were not able to be measured for this part of the study- the primary reason being a weekend delivery that was discharged before measurements could be obtained by the study team. Our clinical research unit was not open on weekends to the the Peapod scans. This explains why there were only 15 babies per group for this outcome.||% fat||Standard Deviation|Mean
9931|NCT02030535|Secondary|QTcB Change From Patient Baseline at Individual Post-dose Time Points|QTcB change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9663|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
9664|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 9 participants from the usual care arm and 9 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
9665|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 12 participants from the usual care arm and 7 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
9666|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 11 participants from the usual care arm and 7 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
9667|NCT02038959|Secondary|Minutes Spend on Last Parkinson's Disease Provider Visit||One year|Data was not collected on 10 participants in the usual care arm and 28 participants in the virtual visits arm.||minutes||Inter-Quartile Range|Median
9668|NCT02038959|Secondary|Change in Patient Assessment of Chronic Illness Care|We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team.|baseline to one year|Data was not collected in 16 participants from the usual care arm and 12 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
9669|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 8 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
9670|NCT02038959|Secondary|Change in Montreal Cognition Assessment|We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition.|baseline to one year|Data was not collected on 6 participants in the usual care arm and 9 participants in the virtual visits arm.||units on a scale||Standard Error|Mean
9671|NCT02038959|Secondary|Change in EQ-5D Index Value|EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.||units on a scale||Standard Error|Mean
9672|NCT02038959|Primary|Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39|Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson’s Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.|Baseline to One year|Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm.||units on a scale||Standard Error|Mean
9673|NCT02038959|Primary|Feasibility of Virtual Visits for Parkinson Disease|Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.|One year|||participants|||Number
9674|NCT02038907|Secondary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participants is unwilling to continue because of the AE.|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9675|NCT02038907|Secondary|Percentage of Participants With Significant New Medical Conditions|"Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder.~Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment."|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9676|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
9677|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
9678|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
9679|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9680|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9681|NCT02038907|Secondary|GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays|"GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.||titer||Standard Deviation|Geometric Mean
9682|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9683|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9684|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9685|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9686|NCT02038907|Secondary|Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9687|NCT02038907|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Baseline (Day 1) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9688|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9689|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9690|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9691|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
9692|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
9693|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9694|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9695|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9696|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9697|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9698|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
9699|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||ratio||Standard Deviation|Geometric Mean
9700|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9701|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||titer||Standard Deviation|Geometric Mean
9722|NCT02038075|Secondary|Scale for Suicide Ideation (SSI)|The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient’s specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.|24 months||||||
9702|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9703|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9704|NCT02038907|Secondary|Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)|"Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."||percentage of participants||95% Confidence Interval|Number
9705|NCT02038907|Primary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 393|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9706|NCT02038907|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Day 1 up to Day 56|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9707|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 2|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.||degrees Celsius||Standard Deviation|Mean
9708|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 1|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.||degrees Celsius||Standard Deviation|Mean
9709|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9710|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9711|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9712|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.||percentage of participants|||Number
9713|NCT02038907|Primary|Percentage of Participants With a Seroresponse (Pan-Ig ELISA)|Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 56|Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.||percentage of participants||95% Confidence Interval|Number
9714|NCT02038075|Other Pre-specified|Post Treatment Health Interview (PTHI)|Frequency, intensity, and location of each patient’s accessing of medical services will be assessed via medical record review.|24 months||||||
9715|NCT02038075|Other Pre-specified|Suicide Cognitions Scale (SCS)|The SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness).|24 months||||||
9716|NCT02038075|Other Pre-specified|Interpersonal Needs Questionnaire (INQ)|The INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness).|24 months||||||
9717|NCT02038075|Other Pre-specified|Suicide Intent Scale|The SIS is a 15-item, interviewer-administered assessment of the intensity of an individual’s intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters’ perceptions of the attempt.|24 months||||||
9723|NCT02038075|Primary|Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up|The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).|24 months|intent to treat||estimated percentage w/ suicide attempt|||Number
9724|NCT02037477|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with markedly abnormal laboratory values for Chemistry, Hematology and Urinalysis during the study is reported.|At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
9725|NCT02037477|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings||At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
9726|NCT02037477|Secondary|Number of Participants With Abnormal Changes From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
9727|NCT02037477|Secondary|Frequency of Adverse Events|The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.|31 days|Safety analysis set - All participants who received at least 1 dose of study drug.||participants|||Number
9728|NCT02037477|Primary|Intragastric pH Time Course Over 24 Hours|Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.|At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)|Pharmacodynamic (PD) Analysis Set - Participants receiving study medication who completed protocol procedures without serious violation of the protocol were eligible for PD analysis. All 10 subjects from Cohort 1 were included. Three subjects in Cohort 2 were excluded from the PD analysis set, which therefore consisted of 7 subjects.||percentage of time||Standard Deviation|Mean
9729|NCT02037425|Other Pre-specified|Neuronal Regrowth|Compare neuronal regrowth in the skin biopsies with duration of benefit of onabotulinumtoxinA in Groups A, B, C from baseline to 12 weeks post randomization. Neuronal regrowth change was scored on a 0-3 point scale with 0 being no change from baseline in regrowth and 3 being significant change from baseline.|Baseline & Week 12 Post Randomization|Only a subset of subjects (n = 14) completed this endpoint for the trial based on the protocol design.||units on a scale||Standard Deviation|Mean
9730|NCT02037425|Secondary|Duration of onabotulinumtoxinA Over 3 Injection Cycles|Compare duration of benefit of onabotulinumtoxinA response through 3 injection cycles as measured by headache days per week (including the last 4 weeks of every injection cycle). A percent of responders was calculated using a 30% reduction of the number of headache days compared to average number of headache per week during baseline.|Weeks 9, 10, 11, 12, 21, 22, 23, 24, 33, 34, 35, 36 Post Randomization|||percentage of responders|||Number
9731|NCT02037425|Secondary|Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles|Compare the consistency of duration of onabotulinumtoxinA response by the group assignment at 12 weeks to assessments at 24, and 36 weeks evaluations as measured by the number of responders. A responder is defined as a 30% reduction from baseline in the number of headache days.|Weeks 12, 24, and 36 Post Randomization|||participants|||Number
9732|NCT02037425|Secondary|Acute Medication Usage|Comparison of acute medication usage between Groups A, B, and C during baseline, Treatment Period 1, 2, and 3.|From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days|||number of medications used||Standard Deviation|Mean
9733|NCT02037425|Secondary|Sleep Quality Question|Comparison between Group A, B, and C for sleep quality scores measured at baseline and weeks 12, 24, and 36 post-randomization. A single sleep quality question was asked indicating quality of sleep over the past four weeks. The scale ranged from 1-5, with 1 being very poor quality and 5 being very good quality of sleep.|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
9734|NCT02037425|Secondary|State-Trait Anxiety Inventory (STAI)|Comparison between Group A, B, and C for STAI scores measured at baseline and weeks 12, 24, and 36. Scores range from 20-80, with 20 indicating lower levels of anxiety most generally, and 80 indicating higher levels of anxiety most generally.|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
9735|NCT02037425|Secondary|Beck Depression Inventory II (BDI-II)|Comparison between Group A, B, and C for BDI-II scores measured at baseline and weeks 12, 24, and 36. A total score of 0-10 = these ups and downs are considered normal, 11-16 = mild mood disturbance,17-20 = borderline clinical depression, 21-30 = moderate depression, 31-40 = severe depression, over 40 = extreme depression|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
9736|NCT02037425|Secondary|Physician Global Impression of Change (PGIC)|Comparison between Group A, B, and C for PGIC scores measured at weeks 12, 24, and 36. the PGIC scale scores range from 0-7 with 0 being Very Much Worse and 7 being Very Much Improved. A higher score indicates a greater impression of change.|Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
9753|NCT02036775|Secondary|Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)|Metric which characterises the rate of absorption at steady state (Cmax ss/AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||1/h||Geometric Coefficient of Variation|Geometric Mean
9737|NCT02037425|Secondary|Social Readjustment Rating Scale (SRRS)|Comparison between Group A, B, and C for SRRS scores (impact of common stressors) measured at baseline and weeks 12, 24, and 36. Scores can range from 0 to an undetermined amount, as subjects are allowed to rate unlisted events according to their own sense of stress. A total lower than 150 suggests a low level of stress and a low probability of developing a stress-related disorder. Scores greater than 150 suggest higher levels of stress and higher probabilities of developing stress-related disorders.|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
9738|NCT02037425|Secondary|Migraine Disability Assessment Scale (MIDAS)|"Comparison between Group A, B, and C for MIDAS total scores (effect migraine headaches have on subjects daily function) measured at baseline and weeks 12, 24, and 36.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline, Week 12, Week 24, and Week 36 Post Randomization|||units on a scale||Standard Deviation|Mean
9739|NCT02037425|Secondary|Headache Days|Comparison of headache days per month over each injection cycle between Groups A, B, and C (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Subjects will remain in their assigned groups based on assessment at 12 weeks.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days|||number of headache days||Standard Deviation|Mean
9740|NCT02037425|Primary|Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C|Compare the duration of onabotulinumtoxinA response through the 3 injection cycles of the study for Groups A, B, and C as measured by headache days during each period (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Duration of response is defined as a 30% reduction in the number of headache days compared to baseline.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days|||percentage of responders|||Number
9741|NCT02037425|Primary|Subject Global Impression of Change|Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C. Subject global impression of change was measured on a 7 point scale with 0 being Very Much Worse and 7 Very Much Improved.|Weeks 12, 24, and 36 Post Randomization|Subjects included in this outcome measure analysis include those completing treatment period 1 injection cycle and returning at visit 3.||units on a scale||Standard Deviation|Mean
9742|NCT02037347|Secondary|Time-to-cessation of Epidermal Necrosis||The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days|||days|||Number
9743|NCT02037347|Secondary|Time-to-mucosal Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days|Adverse event experienced by participant precluded measuring this outcome.|||||
9744|NCT02037347|Primary|Time-to-cutaneous Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days|||days|||Number
9745|NCT02036840|Primary|Number of Subjects With Antibiotic Related Adverse Event||24 hours|||participants|||Number
9746|NCT02036775|Secondary|Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss|Plateau time during which concentration of the analyte in plasma exceeds 75% of Cmax ss (T(C>75% Cmax ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||hours||Full Range|Median
9747|NCT02036775|Secondary|Time Period When Concentration of the Analyte Exceeds Cav ss|Time period when the concentration of the analyte exceeds Cav ss (T (C>Cav ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||hours||Full Range|Median
9748|NCT02036775|Secondary|Peak-trough Swing|Peak-trough swing (PTS) calculated as ((Cmax,ss - Cmin,ss / Cav,ss)*100)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||percentage of ng/mL||Standard Deviation|Mean
9749|NCT02036775|Secondary|Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma|Peak-trough fluctuation between minimum and maximum concentration of the analyte in plasma (PTF)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng/mL||Standard Deviation|Mean
9750|NCT02036775|Secondary|Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State|Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax ss). For Lasolvan 30mg and Lasolvan 60mg, tmax ss was determined as tmax ss 0-12 and tmax ss 12-24.|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||hours||Full Range|Median
9751|NCT02036775|Secondary|Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State|Average concentration of the analyte in plasma in the time interval of 0 to 24 h at steady state (Cav ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9752|NCT02036775|Secondary|Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval|Steady state concentration of the analyte in plasma at the end of dosing interval (Cmin ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9950|NCT02029911|Secondary|Procedure Time|Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal.|< 1 hour|Subjects completing treatment||Minutes||Standard Deviation|Mean
9754|NCT02036775|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg|Area under the concentration-time curve of the analyte in plasma at steady state during 0-24 h, adjusted to a daily dose of 60 mg (AUCss 0-24 norm)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
9755|NCT02036775|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State|Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
9756|NCT02036775|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|Pharmacokinetic (PK) set relative bioavailability set (PK-BA set) which includes all subjects in the treated set who completed 3 periods and for whom the PK profiles in 3 periods could be adequately characterized in respect to at least 1 of the PK parameters of primary interest without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
9757|NCT02036424|Primary|Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven|Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.|baseline to month seven|||microns|Participants|Standard Deviation|Mean
9758|NCT02036424|Primary|Mean Visual Acuity Change|Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.|baseline to month 7|||ETDRS letters|Participants|Standard Deviation|Mean
9759|NCT02035332|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat||participants|||Number
9760|NCT02035332|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.|Day of procedure|Subjects completing treatment||Minutes||Standard Deviation|Mean
9761|NCT02035332|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12-months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75. A score of 0 represents no bleeding.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)||participants|||Number
9762|NCT02036320|Primary|"Lens Does Not Exhibit Hula Hoop Effect"|"The number of subjects that did not exhibit a hula hoop effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp."|15 mins post insertion|The analysis population consists of subjects that completed all study visits, without a major protocol deviation||Subject|||Number
9763|NCT02036320|Primary|Cosmetic Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Eyes|Participants||Number
9764|NCT02036320|Primary|Mechanical Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Eyes|Participants||Number
9765|NCT02035748|Secondary|Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)|Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 180|Full Analysis Set. Missing data is imputed using LOCF. CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.||micrometers||Standard Deviation|Mean
9766|NCT02035748|Secondary|Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180|Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.|Day 180|Full Analysis Set||percentage of subjects|||Number
9767|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis.|Baseline, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after the timepoint of vitrectomy.||percentage of subjects|||Number
9785|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
9768|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline|The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis.|Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after MH closure were considered as 'no MH closure' after the timepoint of vitrectomy.||percentage of subjects|||Number
9769|NCT02035748|Secondary|Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance|BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. BCVA values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.||letters||Standard Deviation|Mean
9770|NCT02035748|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD‐OCT) Evaluation|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.|Baseline, Day 28|This analysis population includes all subjects who received treatment with IP and had at least one post-treatment measurement of SD-OCT (FAS). Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after timepoint of vitrectomy.||percentage of subjects|||Number
9771|NCT02035475|Secondary|Surgical Complications|Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include “no complications” (0), “minor complications” (1), and “major complications” (2).|4 months|||participants|||Number
9772|NCT02035475|Primary|Incidence of Lymphoceles|Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis.|4 months|Lymphoceles were identified by CT scan at 3 months post surgery.||participants|||Number
9773|NCT02035345|Primary|Number of Patients With Carboplatin Reactions of Different Severity|To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.|2 Years|Among the 15 patients enrolled, the HSR rate was 40% which occurred after a median of 2 protocol treatments, which prompted early termination of this study.||participants|||Number
9774|NCT02035345|Primary|Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program|To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program|2 Years|Total number of patients in the study that received carboplatin via slowed infusion.||participants|||Number
9775|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Percentage of participants||95% Confidence Interval|Number
9776|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Percentage of participants||95% Confidence Interval|Number
9786|NCT02034591|Secondary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng/mL||90% Confidence Interval|Geometric Mean
20855|NCT01759251|Secondary|Overall Clinical Response Assessed by Physician|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
9777|NCT02034877|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination|GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination, 1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Fold rise||95% Confidence Interval|Geometric Mean
9778|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Titers||95% Confidence Interval|Geometric Mean
9779|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.||Titers||95% Confidence Interval|Geometric Mean
9780|NCT02034877|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Within 1 month after 13vPnC vaccination|Safety population included all participants who received 1 dose of 13vPnC vaccination.||Percentage of participants|||Number
9781|NCT02034708|Primary|Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent|"Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale:~0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion."|Up to 15 days after randomization|Patients with at least one valid assessment of the primary outcome and without major protocol deviation||percentage of patients|||Number
9782|NCT02034591|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes >1.2* upper limits of normal (ULN) , Basophils >3%, Eosinophils >1.5*ULN, Blood Urine >=2, Red Blood Cell (RBC) Urine >=2, White Blood Cell (WBC) Urine >=2|Day 1 to 30 days after last dose of study drug|All randomized participants||participants|||Number
9783|NCT02034591|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0|Day 1 to 30 days after last dose of study drug|All randomized participants||participants|||Number
9784|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
9990|NCT02029521|Primary|Height Percentile|The subjects were measured over the course of the study to determine if treatment improved height percentile.|6 Months|All participants.||Percentile adjusted for age and sex||Standard Deviation|Mean
9787|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
9788|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data||ng*h/mL||90% Confidence Interval|Geometric Mean
9789|NCT02034591|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available pharmacokinetic (PK) data||ng/mL||90% Confidence Interval|Geometric Mean
9790|NCT02034578|Secondary|Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests|Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX.|Screening, Day -1, Day 4 of Periods, 1, 2, and 3|Participants who received study drug were analyzed.||participants|||Number
9791|NCT02034578|Secondary|Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings|12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge.|Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3|All participants who received study drug were analyzed.||participants|||Number
9792|NCT02034578|Secondary|Mean Plasma Elimination Half-Life (T-HALF) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||h||Standard Deviation|Mean
9793|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL.|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
9794|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||ng*h/mL||90% Confidence Interval|Geometric Mean
9795|NCT02034578|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. Maximum observed plasma concentration (Tmax) was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|||h||Full Range|Median
9796|NCT02034578|Primary|Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.||ng/mL||90% Confidence Interval|Geometric Mean
9797|NCT02034578|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 12|All participants who received study drug were analyzed.||participants|||Number
9991|NCT02029521|Primary|Weight Percentile|Weight percentile, adjusted for sex and age|6 months|All participants.||Percentile adjusted for age and sex||Standard Deviation|Mean
9798|NCT02034565|Secondary|Number of Participants With Marked Laboratory Abnormalities|Clinical laboratory tests were performed pre-study and at selected times throughout the study. Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes < 0.9* lower limits of normal (LLN), absolute neutrophils + bands <= 1.500 10*3 cells/microliter, white blood cells (WBC) urine value >= 2+. These laboratory abnormalities were not considered clinically significant and therefore not adverse events.|Pre-study screen (Day -1) to Day 8 or day of study discharge|All treated participants||participants|||Number
9799|NCT02034565|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related Adverse Events (AEs), Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v13).|Day 1 to 30 days after last dose of study drug|All treated participants||participants|||Number
9800|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data||ng*h/mL||90% Confidence Interval|Geometric Mean
9801|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data||ng*h/mL||90% Confidence Interval|Geometric Mean
9802|NCT02034565|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pharmacokinetic (pk) data||ng/mL||90% Confidence Interval|Geometric Mean
9803|NCT02034162|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole|The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||ng*h/mL||Standard Deviation|Mean
9804|NCT02034162|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole|The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||nanogram hour per Milliliters(ng*h/mL)||Standard Deviation|Mean
9805|NCT02034162|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole|The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||hours||Full Range|Mean
9806|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)|The open-label follow-up safety analysis set consisted of all randomized participants who received a 500-mg chewable tablet of mebendazole at Visit 3. Here 'N' signifies number of participants analysed for this outcome measure.||participants|||Number
9807|NCT02034162|Secondary|Maximum Plasma Concentration (Cmax) of Mebendazole|The Cmax is the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|Pharmacokinetic (PK) population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
9808|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percent change in egg count|||Number
9859|NCT02032758|Primary|Mean Dynamic Change of Rotation at Impact|“Dynamic change of rotation at impact” is the velocity of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.||degrees/sec||Standard Deviation|Mean
9809|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percent change in egg count|||Number
9810|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Visit 3 (Day 19 +/-2)|The safety analysis set consisted of all randomized participants who received 1 dose of study agent (mebendazole or placebo) at baseline. Here 'N' signifies number of participants analysed for this outcome measure.||participants|||Number
9811|NCT02034162|Primary|Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percentage of participants||95% Confidence Interval|Number
9812|NCT02034162|Primary|Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The intent-to-treat (ITT) analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.||percentage of participants||95% Confidence Interval|Number
9813|NCT02033317|Primary|Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)||Day -7 Through Day -1 and Day 1 Through Day 7|||mg/Day||Standard Deviation|Mean
9814|NCT02033317|Primary|Change in Serum Potassium (Day 1 to Day 8)||Day 1 and Day 8|||mmol/L||Standard Deviation|Mean
9815|NCT02033213|Secondary|Total Volume of Administered Intraoperative Fluid|Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.|End of surgery|||milliliters||Standard Deviation|Mean
9816|NCT02033213|Secondary|Duration of Surgery|Total time of Lewis-Tanner procedure will be measured and compared between two groups.|End of surgery.|||minutes||Standard Deviation|Mean
9817|NCT02033213|Primary|Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).|10 minutes, 6 hours|||mmol/L||Standard Deviation|Mean
9818|NCT02033213|Primary|Lactate Values During and After Esophageal Carcinoma Surgery|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.|10 minutes, 6 hours|||mmol/L||Standard Deviation|Mean
9819|NCT02033213|Primary|Creatinine Values During and After Esophageal Carcinoma Surgery|At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.|10 minutes, 6 hours|||μmol/L||Standard Deviation|Mean
9820|NCT02033213|Primary|Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)|At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.|10 minutes, 6 hours|||mmHg||Standard Deviation|Mean
9821|NCT02033200|Secondary|Change From Baseline in Intraocular Pressure 24 Hour Post Dosing|Intraocular pressure was measuring using the Goldman applanation tonometry|24 hours|||mm Hg||Standard Deviation|Mean
9822|NCT02033200|Secondary|Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing||24 hours|||total error score||Standard Deviation|Mean
9823|NCT02033200|Secondary|Change From Baseline in Pupil Dilation 24 Hour Post Dosing||24 hour|||mm||Standard Deviation|Mean
9824|NCT02033200|Secondary|Change From Baseline in Visual Acuity 24 Hours Post Dosing||24 hours|||LogMar||Standard Deviation|Mean
9825|NCT02033200|Primary|Change From Baseline in Intraocular Pressure 1 Hour Post Dosing|Intraocular Pressure was measured using the Goldman applanation tonometry|1 hour|||mm Hg||Standard Deviation|Mean
9826|NCT02033200|Primary|Change From Baseline in Pupil Dilation 1 Hour Post Dosing|Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.|1 hour|||millimeter||Standard Deviation|Mean
9827|NCT02033200|Primary|Change From Baseline in Visual Acuity 1 Hour Post Dosing|Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read.|1 hour|||LogMar||Standard Deviation|Mean
9828|NCT02033200|Primary|Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing|Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced.|1 hour|||total error score||Standard Deviation|Mean
9829|NCT02033174|Primary|Change of Baseline in Concentrations of Antioxidant Profile After Red Wine Intake|In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R&D Systems, Inc. Minneapolis, USA) was conducted.|Baseline and 5 days|||percentage of change in TAC||Inter-Quartile Range|Median
9992|NCT02029521|Secondary|Vitamin E|Serum Vitamin E levels were measured to determine if treatment affected this test.|6 months|All participants.||milligrams per liter||Standard Deviation|Mean
9830|NCT02032901|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Day 1 first dose to last dose plus 7 days|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Participants|||Number
9831|NCT02032901|Primary|Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||percentage of participants||95% Confidence Interval|Number
9832|NCT02032901|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, ''n'' signifies number of participants evaluable for the specified category.||Percentage of participants||95% Confidence Interval|Number
9833|NCT02032901|Secondary|Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.|Baseline, Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies the number of evaluable participants with or without cirrhosis in the reporting arm and time point, respectively.||Percentage of participants||95% Confidence Interval|Number
9834|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
9835|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 6, 8 (treatment period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
9836|NCT02032901|Secondary|Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)|EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Up to the end of treatment (up to 24 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||percentage of participants||95% Confidence Interval|Number
9837|NCT02032901|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)|cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
9838|NCT02032901|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)|RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
9839|NCT02032901|Primary|Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||Percentage of participants||95% Confidence Interval|Number
9840|NCT02032888|Secondary|Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results|Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1–3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9–1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1–10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6–5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1–5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4.|From screening up to week 24 of post treatment follow­-up|All participants who received at least 1 dose of study drug||Participants|||Number
9841|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.|All participants who received at least 1 dose of study drug||Participants|||Number
9842|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)|All participants who received at least 1 dose of study drug.||Participants|||Number
9843|NCT02032888|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR is defined as hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.|At Follow-up Week 12|All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype.||Percentage of participants||95% Confidence Interval|Number
9844|NCT02032888|Secondary|Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants with HCV RNA levels <LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment|All participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
9845|NCT02032888|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24|Participants with hepatitis C virus CV) levels to be <lower limit of quantitation, TD or TND at each visit. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24|All participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
9846|NCT02032888|Secondary|Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA levels <lower limit of quantitation, target detected or target not detected. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
9847|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-experienced participants coinfeted with HCV/HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
9848|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA<lower limit of quantitation, target detected, or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-naive participants coinfected with genotype 1 HCV and HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
9849|NCT02032888|Primary|Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All genotype 1 treatment-naive participants who received at least 1 dose of study therapy. Here, 'number of participants analyzed' (N) signifies the number of participants evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
9860|NCT02032706|Secondary|Assess the Accuracy of Night Shift Measurement of Sleep Efficiency|Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device|one night|Studies included 35 baseline comparisons and 30 comparisons at follow-up||% studies|||Number
9850|NCT02032875|Secondary|Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities|Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50–7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9–50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1–3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9–1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109–0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6–5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1–5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9–3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4.|From start of study treatment up to 7 days post last dose of study treatment|All treated participants.||participants|||Number
9851|NCT02032875|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks)|All treated participants.||participants|||Number
9852|NCT02032875|Secondary|Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be <lower limit of quantitation ie, 25 IU/mL or below target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.||Percentage of participants||95% Confidence Interval|Number
9853|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit.|Week 1, 2, 4, 6, 8, 12, End of treatment|All treated participants.||Percentage of participants||95% Confidence Interval|Number
9854|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit.|Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24|All treated participants.||Percentage of participants||95% Confidence Interval|Number
9855|NCT02032875|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants who took at least 1 dose of study medication. Here, ‘n’ signifies participants evaluable for SVR12 at the specified time point in each group, respectively.||Percentage of participants||95% Confidence Interval|Number
9856|NCT02032875|Primary|Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All genotype 1 cirrhotic participants who received at least 1 dose of study therapy.||Percentage of participants||95% Confidence Interval|Number
9857|NCT02032875|Primary|Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All HCV genotype 1 infected post-transplant participants who received at least 1 dose of study therapy.||Percentage of participants||95% Confidence Interval|Number
9858|NCT02032758|Secondary|Mean Total Putter Face Rotation Before Impact|“Total putter face rotation before impact” is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.||degrees||Standard Deviation|Mean
9926|NCT02030535|Secondary|Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9861|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Measurement of Total Sleep Time|Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.|one night|Comparisons included 35 studies at baseline and 30 follow-up studies||% of studies|||Number
9862|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake|Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.|baseline and follow-up|||percentage of epochs||Standard Deviation|Mean
9863|NCT02032706|Secondary|Evaluate Impact of Positional Therapy on Quality of Life Scores|Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate >2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.|four weeks|||Percentage of participants|||Number
9864|NCT02032706|Secondary|Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA|The percentage of compliant participants who show an improved Epworth Sleepiness Score of >= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.|baseline and followup|||percentage of participants|||Number
9865|NCT02032706|Secondary|Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback|Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use|four weeks|||% participants averaged < 15% supine|||Number
9866|NCT02032706|Secondary|Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant|Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.|four weeks|||Percent of nights||Full Range|Median
9867|NCT02032706|Secondary|Confirmation That Night Shift Accurately Detects Supine Position|Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).|baseline and 4-weeks later at follow up|35 subjects completed the baseline polysomnography (PSG) while wearing the device. One subject's PSG study was conducted prior to enrollment but qualified as a baseline. 30 subjects completed a follow-up PSG.||percentage of participants|||Number
9868|NCT02032706|Primary|Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy|Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.|30-days|||percentage of participants|||Number
9869|NCT02032706|Primary|Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events|Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.|Four weeks|||Percentage of participants|||Number
9870|NCT02032641|Secondary|Hair Loss|After each laser session, subjects were asked to rate perceived amount of hair loss from both the treated and control scars on a 1-10 scale, with 1 being none at all and 10 being extremely significant|within 1 hour after final treatment|Within 1 hour after treatment, subjects were given a mirror and asked to rate perceived hair loss for each side on a 1-10 scale, with 1 representing none and 10 representing very significant||units on a scale|BROW|Standard Deviation|Mean
9871|NCT02032641|Secondary|Overall Appearance|Subjects were asked to rate overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent, as rated by participant|10 minutes before first treatment and at the final visit|Patients were asked to grade overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent. Grading was done 10 minutes prior to each laser treatment and 4 weeks after final treatment||units on a scale|BROW|Standard Deviation|Mean
9872|NCT02032641|Primary|Relative Improvement|Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs|1 month after final treatment|3 graders masked to treatments were asked to judge side-by-side photographs of first and final visits for which scar improved more. Each pair of before-and-after photos was graded twice by each examiner. Results are percentage of times treated scar was chosen by examiners as most improved (an analysis of 6 results per pair of photos).||percentage of times treated scar chosen|BROW|Standard Deviation|Mean
9873|NCT02032420|Post-Hoc|Inability to Complete Assigned Task at All in Three Attempts|Some participants found the task too difficult to complete.|Immediately after training|||participants|||Number
9874|NCT02032420|Secondary|Performer Fatigue|Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue|During task|||units on a scale||Inter-Quartile Range|Median
9875|NCT02032420|Secondary|Needle-not-seen Time|Median percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm|During attempt|||percentage of attempt time||Inter-Quartile Range|Median
9876|NCT02032420|Primary|Task Completion Time|Median time taken to complete 3 iterations of the assigned task, across participants within a study arm|Immediately after training|||seconds||Inter-Quartile Range|Median
9877|NCT02032407|Secondary|ASIS Impact Domain Score|The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available for analysis at the given time-point.||score on a scale||Standard Deviation|Mean
9993|NCT02029521|Secondary|White Blood Cell Count|White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.|6 months|All participants.||1000 cells/mm^3||Standard Deviation|Mean
9878|NCT02032407|Secondary|Acne Symptom and Impact Scale (ASIS) Sign Domain Score|The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data at the given time-point.||score on a scale||Standard Deviation|Mean
9879|NCT02032407|Secondary|Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.|Weeks 2, 6 and 12|Participants from the mITT, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percentage of participants|||Number
9880|NCT02032407|Secondary|Percent Change From Baseline in Non-Inflammatory Lesion Counts|The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percent change||Standard Deviation|Mean
9881|NCT02032407|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts|The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percent change||Standard Deviation|Mean
9882|NCT02032407|Secondary|Percent Change From Baseline in Total Lesion Counts|The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.||percent change||Standard Deviation|Mean
9883|NCT02032407|Secondary|Change From Baseline in the GAAS|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Weeks 2 and 6|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
9884|NCT02032407|Primary|Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
9885|NCT02032212|Secondary|Nicotine Craving|Craving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as “I have a desire for a cigarette right now”, by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette.|30 minutes after the third product use|||score on a scale||Standard Deviation|Mean
9886|NCT02032212|Secondary|Nicotine Withdrawal Symptoms|Withdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject’s part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60.|30 minutes after the third product use|||score on a scale||Standard Deviation|Mean
9887|NCT02032212|Secondary|Exhaled Carbon Monoxide|Measured with a Smokerlyser device|25 minutes|||ppm||Standard Deviation|Mean
9888|NCT02032212|Primary|Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)||1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours|||min*ng/ml||Geometric Coefficient of Variation|Geometric Mean
9889|NCT02032212|Primary|Nicotine Plasma Concentration|Maximum plasma nicotine concentration (Cmax)|1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
9890|NCT02031471|Secondary|Safety: Percentage of Participants With Anti-tocilizumab Antibodies||Baseline, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
9927|NCT02030535|Secondary|Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9891|NCT02031471|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 52 weeks|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
9892|NCT02031471|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM ) Scores|The abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) derived from the TSQM Version 1.4 but without the five items of the side effects domain, is a reliable and valid measure to assess participants’ satisfaction with treatment. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Domains included are effectiveness, convenience and global satisfaction.|Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9893|NCT02031471|Secondary|Change From Baseline in Work Instability Scale for Rheumatoid Arthritis (RA-WIS)|The 23-item RA-WIS is a simple, validated screening tool for work instability, i.e., the consequences of a mismatch between an individual’s functional ability and their work tasks. This self-administered questionnaire covers a broad range of specific work-related issues and enables monitoring the risk of work disability in rheumatoid arthritis patients. The RA-WIS is scored by summing responses from all 23 scale items. The scale ranges from 0 to 23. Cut points have been established to differentiate levels of work instability: low < 10, moderate 10-17 and high > 17. A negative change from baseline indicates an improvement.|From Baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9894|NCT02031471|Secondary|Change From Baseline in Patient Satisfaction VAS|The Patient Satisfaction VAS assessment represents the participant’s assessment of his/her current satisfaction with treatment on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no satisfaction” and the extreme right end 100=“extremely satisfied”. A positive change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9895|NCT02031471|Secondary|Change From Baseline in Patient Fatigue VAS|The Patient Fatigue VAS assessment represents the participant’s assessment of his/her current level of fatigue on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no fatigue” and the extreme right end 100=“extreme fatigue”. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9896|NCT02031471|Secondary|Change From Baseline in Arthritis Impact Measurement Scale-Short Form (AIMS-SF)|The AIMS-SF is a reduced version of the validated AIMS2 questionnaire. The Short Form has been developed using a comprehensive expert-based approach and supported by psychometric testing. The AIMS-SF is a self-administered questionnaire to measure changes in global health, pain, mobility and social function in adult patients with arthritis and reports scores for physical, symptoms, affect, social and work assessments. Scores range from 0 to 10, higher scores indicating higher impact of arthritis on the assessments. A negative change from baseline indicates an improvement.|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9897|NCT02031471|Secondary|Change From Baseline in Patient Quality of Sleep VAS|The Patient Quality of Sleep VAS assessment represents the participant’s assessment of his/her current quality of sleep on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no difficulty to sleep” and the extreme right end 100=“extreme sleeping difficulties”. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9898|NCT02031471|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over 1-month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The participant self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. Global scores range from 0 to 21 and a global sum of “5” or greater indicates a “poor” sleeper. Although there are several questions that request the evaluation of the participant’s bed mate or roommate, these are not scored. A negative change from baseline indicates an improvement.|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9928|NCT02030535|Secondary|PR Change From Patient Baseline at Individual Post-dose Time Points|PR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9929|NCT02030535|Secondary|Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
10102|NCT02026141|Other Pre-specified|VAS Scores|Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark.|6, 12 and 24 hour marks.||||||
9899|NCT02031471|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The symptom-specific measure FACIT-F was developed to assess chronic illness therapy with special emphasis on fatigue in the past 7 days. In this study, only the FACIT-F short questionnaire, which is a shorter version of the initial FACIT-F questionnaire, was used. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. The 13 items included in the FACIT-F short can be used to calculate the brief score for FACIT-F scale (score range: 0-52). A positive change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9900|NCT02031471|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9901|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in ESR|A negative change from baseline in ESR indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||millimeters per hour (mm/hr)||Standard Deviation|Mean
9902|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in CRP|A negative change from baseline in CRP level indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||milligrams per liter (mg/L)||Standard Deviation|Mean
9903|NCT02031471|Secondary|Change From Baseline in Patient’s Assessment of Pain VAS|Patient’s Assessment of Pain VAS represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no pain” and the extreme right end 100=“unbearable pain”. A negative change from baseline indicates an improvement.|From Baseline to Week 2 and Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9904|NCT02031471|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity VAS|PGA VAS represents the participant’s overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end 100=“maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9905|NCT02031471|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity VAS|Physician’s Global Assessment of disease activity VAS represents the physician’s assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end 100= “maximum disease activity”. This was completed by the Treating Physician (or designee). A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9906|NCT02031471|Secondary|Percentage of Participants Achieving a Clinically Significant Improvement in DAS28|The DAS28 score is a measure of the participant’s disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
9907|NCT02031471|Secondary|Percentage of Participants Achieving DAS28-ESR Remission, DAS28-ESR LDA, Moderate Disease Activity and High Disease Activity|The DAS28 score is a measure of the participant’s disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. Clinical remission = score <2.6; Low disease activity = score ≥2.6 and ≤3.2; Moderate disease activity = score > 3.2 and ≤5.1; High disease activity = score >5.1.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
10103|NCT02026141|Secondary|Time of First Analgesia Request||time of first analgesia request from closure of skin up to 24 hours.||||||
9908|NCT02031471|Secondary|Percentage of Participants Achieving SDAI Remission, SDAI LDA, Moderate Disease Activity and High Disease Activity|SDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total SDAI score ranges from 0 to 86 with higher scores indicating increased disease activity. Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; high disease activity = score > 26.0.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
9909|NCT02031471|Secondary|Percentage of Participants Achieving CDAI Remission, CDAI Low Disease Activity, Moderate Disease Activity and High Disease Activity|CDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total CDAI score ranges from 0 to 76 with higher scores indicating increased disease activity. Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; High disease activity = score > 22.0.|Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
9910|NCT02031471|Secondary|Percentage of Participants With Corticosteroid Dose Reduction/Discontinuation||Up to Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
9911|NCT02031471|Secondary|Change in Total Tender/Swollen Joint Counts (TJC/SJC)|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure||Joint Counts||Standard Deviation|Mean
9912|NCT02031471|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI)|SDAI is a similar index to DAS28 but has the advantage of not needing a complicated mathematical formula for its determination, but a simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. CDAI does not incorporate an acute response, therefore it can be used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. SDAI scores ranged from 0 to 86, CDAI from 0 to 76 with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9913|NCT02031471|Secondary|Percentage of Participants With Responses According to European League Against Rheumatism (EULAR ) Criteria|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of <=3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to <=1.2 with a DAS28 score of <=5.1; non-responders = decrease from baseline <=0.6 or decrease from baseline >0.6 and <=1.2 with a DAS28 score of >5.1.|From Baseline to Week 2, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
9914|NCT02031471|Secondary|Percentage of Participants With Positive American College of Rheumatology (ACR) Response Scores|The ACR core set of outcome measures and their definition of improvement includes a >= 20% improvement (ACR20) compared to Baseline in both SJC and TJC as well as in three out of five additional parameters: Physician’s Global Assessment of disease activity VAS, PGA VAS, patient’s assessment of pain VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and acute phase reactant (CRP or ESR). VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Achievement of an ACR50 requires a >= 50% improvement in the same parameters and an ACR70 requires a >= 70% improvement.|From Baseline to Week 2, Week 24, and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
9915|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Per Protocol Set (PPS)|The DAS28 score is a measure of the participant’s disease activity calculated using the TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS and acute phase reactant (ESR or CRP) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The PPS consisted of all participants of the FAS having a value at baseline and at Week 24 for the endpoint DAS28-ESR, excluding sponsor defined deviation(s) which could have affected the evaluation of the primary endpoint (DAS28-ESR). Here, n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9930|NCT02030535|Secondary|Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9916|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Full Analysis Set (FAS)|The DAS28 score is a measure of the participant’s disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient’s global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.||Units on a scale||Standard Deviation|Mean
9917|NCT02030600|Secondary|FPG (Fasting Plasma Glucose)|Fasting plasma glucose values at week 32 and week 64.|week 32, week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.||mg/dL||Standard Deviation|Mean
9918|NCT02030600|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64.|Week 32, Week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
9919|NCT02030600|Secondary|Incidence of Treatment Emergent Adverse Events|Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|During 32 weeks of treatment for each treatment period|Safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator (Total number of subjects analysed for this endpoint: 713).||events|||Number
9920|NCT02030600|Secondary|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period|Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set. Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on subjects in full analysis set with exposure in both maintenance periods.||percentage of subjects|||Number
9921|NCT02030600|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period|Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set||events|||Number
9922|NCT02030600|Primary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set||events|||Number
9923|NCT02030574|Secondary|Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer|Toxicities assessed while patients are on treatments|Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)|||participants|||Number
9924|NCT02030574|Primary|Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.|Response will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 [Eur J Cancer. 2009;45:228-247.].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficie|at approximately 6 months|||participants|||Number
9925|NCT02030535|Secondary|QRS Change From Patient Baseline at Individual Post-dose Time Points|QRS change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9932|NCT02030535|Secondary|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9933|NCT02030535|Secondary|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9934|NCT02030535|Secondary|QT Change From Patient Baseline at Individual Post-dose Time Points|QT change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9935|NCT02030535|Secondary|Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9936|NCT02030535|Secondary|Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9937|NCT02030535|Secondary|RR Change From Patient Baseline at Individual Post-dose Time Points|RR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9938|NCT02030535|Secondary|Peak RR Change From Patient Baseline Over All Post-dose Time Points|Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9939|NCT02030535|Secondary|Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9940|NCT02030535|Secondary|Heart Rate Change From Patient Baseline at Individual Post-dose Time Points|Heart rate change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||bpm||Standard Deviation|Mean
9941|NCT02030535|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration|"The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).~For patients who did not complete all periods, patient baseline was the average of the available period baselines.~The means presented are the adjusted means."|1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose|Full Analysis Set (FAS): This patient set included all patients in the TS who had at least 1 visit (Visit 2(Day1), Visit 3(Day22), or Visit 4(Day43)) with both the period baseline value plus any evaluable post-dose spirometry measurement from the same visit.||Litres||Standard Error|Mean
9942|NCT02030535|Secondary|Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||bpm||Standard Deviation|Mean
9943|NCT02030535|Secondary|Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||bpm||Standard Deviation|Mean
9944|NCT02030535|Secondary|Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9945|NCT02030535|Secondary|Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)||ms||Standard Deviation|Mean
9946|NCT02029989|Secondary|Sustainability of Cholestech LDX ® Glucose/Lipid and Glycosylated Hemoglobin A1c Now® Testing|Assess sustainability by comparing third party payor reimbursements for Cholestech LDX ® glucose/lipid and glycosylated hemoglobin A1c Now® tests to the actual cost of laboratory testing over a 12 month duration in community mental health clinic settings.|12 months||||||
9947|NCT02029989|Secondary|Comprehensive Medication Management (CMM) Service|Evaluate pharmacist provided comprehensive medication management (CMM) services ability to: (a) identify and reduce the number of drug therapy related problems (i.e., need for additional medications, non-adherence, unnecessary drug therapy problems, etc.) and increase primary care follow-up visits in the past 12 months compared to controls; (b) Reduce the odds of metabolic syndrome by increasing the number of subjects achieving treatment goals for dyslipidemia, hypertension, and diabetes based POCT analyses and the criteria established by the American Diabetes Association (ADA) 2013, National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III, and Joint National Committee 7 (JNC-7) at the end of 12-months compared to controls.|Baseline, 6 months, and 12 months||||||
9948|NCT02029989|Primary|Metabolic Syndrome (MetS)|Detect the percentage of subjects on antipsychotic agents who met MetS criteria established by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP-III) and National Heart Lung and Blood Institute (NHLBI) using glucose/lipid and glycosylated A1c capillary blood testing and compare test results in subjects with or without pre-existing MetS and/or related metabolic conditions at baseline.|Baseline|||percentage of participants|||Number
9949|NCT02029911|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat||participants|||Number
9951|NCT02029911|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat populations (all subjects in whom the experimental device was attempted to be placed)||participants|||Number
9952|NCT02029755|Secondary|Number of Participants With Intervention-related Complication|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
9953|NCT02029755|Secondary|Length of Hospital Stay|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
9954|NCT02029755|Secondary|Time to Flatus|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
9955|NCT02029755|Secondary|Heart Rate Variability||preoperative, postoperative 1 hour and 1 day||||||
9956|NCT02029755|Secondary|Quality of Recovery 40||postoperative 48 hour||||||
9957|NCT02029755|Secondary|Pruritus||postoperative 1, 6, 24, 48 hour||||||
9958|NCT02029755|Secondary|Time to the First Request of Analgesics|participants will be followed for the duration of hospital stay|an expected average of 5 days||||||
9959|NCT02029755|Secondary|Rescue Antiemetics Use||postoperative 1, 6, 12, 24, 36, 48 hour||||||
9960|NCT02029755|Secondary|Rescue Analgesic Use||postoperative 1, 6, 12, 24, 36, 48 hour||||||
9961|NCT02029755|Secondary|Nausea and Vomiting Categorical Score||postoperative 1, 6, 24, 48 hour||||||
9962|NCT02029755|Secondary|Sedation Scale||postoperative 1, 6, 24, 48 hour||||||
9963|NCT02029755|Primary|Opioid Consumption|opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).|postoperative 48 hour|||mg||Standard Deviation|Mean
9964|NCT02029755|Primary|Pain Score (NRS: Numerical Rating Scale)|"pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours).~(NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome."|postoperative 24 hour dynamic|||units on a scale||Standard Error|Mean
9965|NCT02029521|Secondary|Severity of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9966|NCT02029521|Secondary|Frequency of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9967|NCT02029521|Secondary|Severity of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9968|NCT02029521|Secondary|Frequency of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9969|NCT02029521|Secondary|Severity of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9970|NCT02029521|Secondary|Frequency of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9971|NCT02029521|Secondary|Severity of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9972|NCT02029521|Secondary|Frequency of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9973|NCT02029521|Secondary|Severity of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9974|NCT02029521|Secondary|Frequency of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9975|NCT02029521|Secondary|Severity of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9976|NCT02029521|Secondary|Frequency of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9977|NCT02029521|Secondary|Severity of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9978|NCT02029521|Secondary|Frequency of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9979|NCT02029521|Secondary|Severity of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9980|NCT02029521|Secondary|Frequency of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9981|NCT02029521|Secondary|Severity of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9982|NCT02029521|Secondary|Frequency of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9983|NCT02029521|Secondary|Severity of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9984|NCT02029521|Secondary|Frequency of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9985|NCT02029521|Secondary|Severity of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months|||participants|||Number
9986|NCT02029521|Secondary|Frequency of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months|||participants|||Number
9987|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|6 Months|||participants|||Number
9988|NCT02029521|Secondary|Alanine Aminotransferase (ALT)|ALT was measured to determine if liver function was affected by treatment over the course of the study.|6 Months|All participants.||units per liter||Standard Deviation|Mean
9989|NCT02029521|Primary|Fecal Calprotectin|Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.|6 months|All participants.||Micrograms/gram feces||Standard Deviation|Mean
20856|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period||From 2 months to 4 months||||||
9994|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.|6 months|All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age||Percentile adjusted for age and sex||Standard Deviation|Mean
9995|NCT02029521|Secondary|C-Reactive Protein (CRP)|CRP was measured to determine if this test fell during the course of treatment.|6 months|All participants.||milligrams per liter||Standard Deviation|Mean
9996|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted.|6 months|PFT's not done on children under age of 5.||Percent predicted||Standard Deviation|Mean
9997|NCT02029521|Secondary|Forced Vital Capacity|Percent predicted of forced vital capacity.|6 months|PFT's not done on children under age of 5.||Percent Predicted||Standard Deviation|Mean
9998|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|3 months|||participants|||Number
9999|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5||Percent predicted||Standard Deviation|Mean
10000|NCT02029521|Secondary|Forced Vital Capacity|Forced vital capacity percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5||percent predicted||Standard Deviation|Mean
10001|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age|3 months|BMI percentile not available for children under 2 years of age.||Percentile adjusted for age and sex||Standard Deviation|Mean
10002|NCT02029521|Primary|Height Percentile|Height Percentile adjusted for sex and age|3 months|All participants.||Percentile adjusted for age and sex||Standard Deviation|Mean
10003|NCT02029521|Primary|Weight Percentile at 3 Months|Weight Percentile at 3 months adjusted for sex and age|3 months|All participants.||Weight Percentile, sex and age adjusted||Standard Deviation|Mean
10004|NCT02029417|Primary|Frequency of Adverse Events, Graded According to NCI CTCAE v4.0|Maximum grade per participant of any AE.|Up to 30 days after last dose of study drugs|All treated and eligible patients.||participants|||Number
10005|NCT02029417|Primary|Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups|Defined as recovery of morphologically normal bone marrow (< 5% blasts) and blood counts (absolute neutrophil count >= 1x10^9/L, platelet counts >= 100x10^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated.|Up to 4 years|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
10006|NCT02028780|Secondary|AUEC2-12|"Area under the effect curve over the time interval from 2 to 12h, AUEC2-12 on Days 4 and 11 for diluted thrombin time (dTT).~For dose groups 5 to 7(day4-Part-II): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h on day 4. For dose groups 5 to 7(day11-Part-II): 242h, 242.083h, 242.167h, 242.5h, 243h, 244h, 246h, 248h, 250h, 252h. For dose groups 8(day4-Part-II): 74.5 h, 78 h, 84 h on day 4. For dose groups 8(day11-Part-II): 242h, 242.083h,242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h on day 11.~AUEC is calculated by multiplying the ratio (Value at each time point/Ebase, unit of Vaue is [s] and Ebase is value [s] at baseline) by time. Therefore, Unit for AUEC2-12 is [h]."|Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section|Pharmacodynamic set (PDS): The PDS comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment pharmacodynamic observation.||h||Standard Deviation|Mean
10007|NCT02028780|Secondary|Ae0-73 for the Dose Group 4 in the Part I|Amount of the analyte excreted in urine over the time interval 0-73|For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h|PKS set. The results from dose group 4 has been disclosed, because only dose group 4 had 1hr infusion, Ae 0-73 was reported, instead of Ae0-72.||μmol||Geometric Coefficient of Variation|Geometric Mean
10008|NCT02028780|Secondary|Ae0-72 for Idarucizumab in the Part I & Part II.|Amount of idarucizumab eliminated in urine over the time interval 0-72. Time frame: For dose groups 1 to 3 (day1 to day4-Part-1):0–4 h, 4–8 h, 8–12 h, 12–24 h, 24–48 h, 48–72 h. For dose groups 5 to 7 (day 11 to day14-Part-II): 0-4 h, 4–8 h, 8–10 h, 10–12 h,12–24 h, 24–48 h, and 48–72 h. For dose groups 8 (day11 to day14-Part-II): 0-4h, 4–8 h, 8–10 h, 10–24 h, 24–48 h, 48–72 h.|Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section|PKS set. Ae 0-72 data is not available for BI8000mg_1h (Dose group 4 - Part I) due to longer infusion time resulting different urine collection interval. Instead, Ae 0-73 is presented for BI8000mg_1h as separate endpoint.||μmol||Geometric Coefficient of Variation|Geometric Mean
10009|NCT02028780|Secondary|AUC0-inf for Idarucizumab in the Part I & Part II.|"Area under the concentration-time curve of the analyte in plasma for idarucizumab over the time interval from 0 extrapolated to infinity.~Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h."|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
10010|NCT02028780|Secondary|Cmax for Idarucizumab in the Part I & Part II.|Maximum measured concentration of the analyte in plasma for idarucizumab Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h.|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
10011|NCT02028780|Secondary|AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).|"Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours.~Time Frame: For dose group 5 to 7 (Day 1 to 3-Part-I):74hours (h), 74.5h, 75h, 76h, 78h, 80h, 82h, 84h, For dose group 8 (Day 1 to 3-Part-I): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h and For dose group 5-7 (Day11 to Day13-Part II):242h, 242.167h, 242.5h, 243h, 244h,246h, 248h, 250h, 252h. For dose group 8 (Day11 to Day13-Part II):242h, 242.083h, 242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h."|Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section|PKS set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10012|NCT02028780|Secondary|Ae0−74,ss on Days 4 and 11 for Sum Dabigatran (Part II)|Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours.|0–2 h, 2–6 h, 6–10 h, 10–12 h,12–14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.|PKS set: This subject set included all subjects who received the idarucizumab and who had at least one pharmacokinetic parameter. For the Part 2, subjects who had the emesis with onset at or before twice the median tmax of dabigatran were not included in this set.||μg||Geometric Coefficient of Variation|Geometric Mean
10013|NCT02028780|Primary|Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2|Percentage of subjects with drug-related adverse events in Part 1 and Part 2.|From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)|Treated set (TS)||Percentage of participants|||Number
10014|NCT02028767|Secondary|AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-infinity) (Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10015|NCT02028767|Primary|Cmax (Maximum Measured Concentration of Metformin in Plasma)|Cmax (maximum measured concentration of metformin in plasma)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10016|NCT02028767|Primary|AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)|AUC (0-tz) (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10017|NCT02028754|Secondary|Subjective Symptom Total Score in the Study Eye|The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst).|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
10018|NCT02028754|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
10019|NCT02028754|Secondary|Results of Schirmer I Test With Anesthetics in the Study Eye|The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms.|Day 7, Day 30|All patients with data at this time point||Millimeters||Standard Deviation|Mean
10020|NCT02028754|Secondary|Lissamine Green Staining Score in the Study Eye|Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
10021|NCT02028754|Secondary|Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point||Scores on a Scale||Standard Deviation|Mean
10022|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 30|All patients with data at this time point||Seconds||Standard Deviation|Mean
10023|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 7|All patients with data at this time point||Seconds||Standard Deviation|Mean
10024|NCT02028676|Secondary|Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||% of visits reporting missed pills||Standard Deviation|Mean
10025|NCT02028676|Secondary|Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10026|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants aged >5 years at randomization to stop versus continue alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
10027|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%||percentage of total lymphocytes||Standard Deviation|Mean
10028|NCT02028676|Secondary|Cotrimoxazole: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||age-adjusted z-score||Standard Deviation|Mean
10029|NCT02028676|Secondary|Cotrimoxazole: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||age-adjusted z-score||Standard Deviation|Mean
10030|NCT02028676|Secondary|Cotrimoxazole: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||age-adjusted z-score||Standard Deviation|Mean
10031|NCT02028676|Secondary|Cotrimoxazole: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10032|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10033|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea|Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10034|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10035|NCT02028676|Secondary|Cotrimoxazole: New Severe Pneumonia|Number of participants with a new severe pneumonia, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10036|NCT02028676|Secondary|Cotrimoxazole: New Clinical and Diagnostic Positive Malaria|Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT)|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10037|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||% of visits reporting missed pills||Standard Deviation|Mean
10038|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks.|96 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire||participants|||Number
10039|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks.|48 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire||participants|||Number
10040|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
10041|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
10042|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||age-adjusted z-score||Standard Deviation|Mean
10043|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||age-adjusted z-score||Standard Deviation|Mean
10044|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||age-adjusted z-score||Standard Deviation|Mean
10045|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
10046|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
10047|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
10048|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Randomisation to once vs twice daily, week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
10049|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Baseline, week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
10050|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Randomisation to once vs twice daily, week 48|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured||cells per mm3||Standard Deviation|Mean
10051|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96||Randomisation to once vs twice daily, week 96|All participants alive in follow-up with CD4%||percentage of lymphocytes||Standard Deviation|Mean
10052|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%||percentage of total lymphocytes||Standard Deviation|Mean
10053|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48||Randomisation to once vs twice daily, week 48|All participants alive in follow-up with CD4%||percentage of total lymphocytes||Standard Deviation|Mean
10054|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|96 weeks|All participants with viral load assayed in stored specimens (98% of those randomized)||participants|||Number
10055|NCT02028676|Secondary|LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||% of visits reporting missed pills||Standard Deviation|Mean
10056|NCT02028676|Secondary|LCM vs CDM, Induction ART: New ART-modifying Adverse Event|Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
20857|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period||From Day 0 to 2 months||||||
10057|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse events not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10058|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART|Number of participants with a new grade 3 or 4 adverse event definitely/probably or uncertainly related to ART, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10059|NCT02028676|Secondary|LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure|Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10060|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|144 weeks|Viral load was assayed retrospectively at week 144 on a random subset of participants, plus all those aged <5 years at enrolment||participants|||Number
10061|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|72 weeks|Viral loads were assayed retrospectively in a random subset of children||participants|||Number
10062|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 144|All participants alive in follow-up with CD4||absolute cells per mm3||Standard Error|Mean
10063|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants alive in follow-up with CD4||absolute cells per mm3||Standard Error|Mean
10064|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 144||Baseline, week 144|All participants alive in follow-up with CD4% (95% completeness)||percentage of total lymphocytes||Standard Error|Mean
10065|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4% (97% completeness)||percentage of total lymphocytes||Standard Error|Mean
10066|NCT02028676|Secondary|LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)|||age-adjusted z-score||Standard Deviation|Mean
10067|NCT02028676|Secondary|LCM vs CDM, Induction ART: Height-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)|||age-adjusted z-score||Standard Deviation|Mean
10068|NCT02028676|Secondary|LCM vs CDM, Induction ART: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)|||age-adjusted z-score||Standard Deviation|Mean
10069|NCT02028676|Secondary|LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death|Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10070|NCT02028676|Secondary|LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10071|NCT02028676|Secondary|Induction ART: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10072|NCT02028676|Secondary|LCM vs CDM, Induction ART: All-cause Mortality|Number of participants who died from any cause, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10073|NCT02028676|Primary|Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10074|NCT02028676|Primary|Cotrimoxazole: New Hospitalisation or Death|Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)|||participants|||Number
10104|NCT02026141|Primary|Morphine Consumption|Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.|24 hours|||milligrams||Standard Deviation|Mean
12662|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
10075|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)|||participants|||Number
10076|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression.|48 weeks|All randomized participants with VL result from stored plasma specimen (available for 661/669, 99%, randomized participants)||participants|||Number
10077|NCT02028676|Primary|Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10078|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation||Baseline, 144 weeks|All participants alive in follow-up with CD4% (95% completeness)||percentage of total lymphocytes||Standard Error|Mean
10079|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation||Baseline, 72 weeks|All participants alive at 72 weeks with CD4 measured (completeness in those in follow-up was 96.6%).||percentage of total lymphocytes||Standard Error|Mean
10080|NCT02028676|Primary|LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|||participants|||Number
10081|NCT02028676|Primary|LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death|Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|All randomized participants (time-to-event)||participants|||Number
10082|NCT02028325|Primary|Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging|We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.|up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation.|||participants|||Number
10083|NCT02028065|Secondary|Percentage of Participants With Adjudicated Anaphylaxis|The investigator or designated clinician performed a THA in each participant at 0.5, 4 and 24 hours after each dose. The THA could also be performed at other times if possible hypersensitivity signs were observed. Each potential hypersensitivity case identified by presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of anaphylaxis (yes/no) using Sampson Criterion 1 - Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure or associated symptoms of end-organ dysfunction (J Allergy Clin Immunol 2006;117:391-397). All AEs occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.||percentage of participants||95% Confidence Interval|Number
10084|NCT02028065|Primary|Percentage of Participants With Adjudicated Symptoms of Hypersensitivity|The investigator or designated clinician performed a targeted hypersensitivity assessment (THA) in each participant at 0.5, 4 and 24 hours after each dose for each dosing period. The THA could also be performed at other times if possible hypersensitivity signs were observed. The THA included elicitation of symptoms as well as examination of the participant, covering neurologic, pulmonary, cardiovascular, gastrointestinal and dermatologic domains. Each potential hypersensitivity case identified by the presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of hypersensitivity (yes/no). In addition, all adverse events (AEs) occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.||percentage of participants||95% Confidence Interval|Number
10085|NCT02027883|Other Pre-specified|Safety Monitoring|Number of participants that were monitored for safety issues, including increased heart rate, blood pressure, decreased oximetry levels, and stable rhythm during the entire procedure.|2 hours|||participants|||Number
10086|NCT02027883|Secondary|Factors|Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.|2 hours|||participants|||Number
10087|NCT02027883|Primary|Sustained Ventricular Fibrillation|The primary endpoint is the successful induction of sustained ventricular fibrillation.|2 hours|||participants|||Number
10105|NCT02025907|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
10088|NCT02027844|Other Pre-specified|Postoperative Behavioral Changes|"The investigators measure negative postoperative behavioral change of children after discharge of postanesthetic care unit using posthospital behavioral questionnaires( PHBQ ) at postoperative day (POD) 1 by visiting and followed at POD 14 by phone interview.~The PHBQ consists of 27 items concerning sleep, eating, anxiety, aggressive behaviour, etc.~The subscales were: general anxiety and regression, separation anxiety, anxiety about sleep, eating disturbance, aggression towards authority, and withdrawal.~Negative behavior change was evaluated in 6 subscales categories. If more than one negative behavior change developed, the investigators calculated number of children who developed new-onset negative behavior change."|1. postoperative 2 days, 2 postoperative 14 days|If more than one negative behavior change in children developed, the investigators calculated number of the children who developed new-onset negative behavior change.||participants|||Number
10089|NCT02027844|Other Pre-specified|Postoperative Emergence Delirium|"The investigators measure postoperative emergence delirium of children after recovery of anesthesia using Children's Hospital of Eastern Ontario Pain(CHEOP) Scale at 20 minute in postanesthetic care unit~The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort.~CHEOPS pain score = SUM(points for all 6 parameters) : Cry, facila, Child verbal, Torso, Touch, legs~Interpretation:~minimum score: 4 = no pain~maximum score: 13 = the worst pain~When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present."|at 20 minute in postanesthetic care unit|When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.||participants|||Number
10090|NCT02027844|Secondary|Change From Baseline Parental Anxiety at Postinduction of Anesthesia|"The investigators measure change of parental anxiety using State-Trait Anxiety Inventory (STAI)~The State-Trait Anxiety Inventory (STAI) is a psychological inventory and consists of 40 questions on a self-report basis.~The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.~Higher scores are positively correlated with higher levels of anxiety.~Each type of anxiety has its own scale of 20 different questions that are scored.~Scores range from 20 to 80, with higher scores correlating with greater anxiety."|1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia|||units on a scale||Inter-Quartile Range|Median
10091|NCT02027844|Primary|Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction|"The investigators measure change in anxiety of children using Modified Yale Preoperative Anxiety scale (m-YPAS): Scale changes from Activities, Vocalization, Expressing emotions, State of arousal, Interaction with family members.~Each domain received a partial score based on the punctuation observed divided by the number of categories of that domain. The score of each domain is added to the others~Total scores ranged from 23.4 to 100 The scores considered “cut points” to determine whether a patient had/had not anxiety were 23~Without anxiety: 23.4 e 30~With anxiety: greater than 30."|1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane|||units on a scale||Inter-Quartile Range|Median
10092|NCT02027402|Secondary|Postoperative Pain Score|Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.|6hr after operation - 24hr after operation - 48hr after operation|||units on a scale||Standard Deviation|Mean
10093|NCT02027402|Secondary|Postoperative Hospital Stay||2weeks|||day||Standard Deviation|Mean
10094|NCT02027402|Secondary|Operative Time||1day|||minutes||Standard Deviation|Mean
10095|NCT02027402|Primary|Complication|complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.|2 weeks|||participants|||Number
10096|NCT02027311|Secondary|Event of Hypoxia|Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%|Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase|||Hypoxia events|||Number
10097|NCT02027311|Primary|Number of Intervention|The frequency of intervention which was defined as any restraint of the patient’s head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.|Throughout the whole ERCP procedure|||Number of intervention||Standard Deviation|Mean
10098|NCT02027272|Primary|Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery|To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.|36 months|Logistic hurdles caused to stop the study after the first participant and not proceed further. No analysis was undertaken.|||||
10099|NCT02026206|Secondary|Quality of Life|The secondary outcome measures were quality of life as assessed by the EQ-5D (minimun 0.00, maximum 1.00). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to EQ-5D equation formula. The higher values represent a better outcome.All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity and quality of life after the next menstruation started (pre-treatment score) using the EQ-5D questionnaire. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of quality of life after the next menstruation started (post-treatment score) using the EQ-5D questionnaire.|within 3 months after treatment|||units on a scale||Standard Deviation|Mean
10100|NCT02026206|Primary|Dysmenorrheal Pain Severity|The primary outcome was menstrual pain intensity described using a 0-10 VAS scale (minimum 0, maximum 10). The higher values represent a worse outcome. All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity after the next menstruation started (pre-treatment score) using the VAS. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of pain intensity after the next menstruation started (post-treatment score) using the VAS.|within 3 months after treatment|||units on a scale||Standard Deviation|Mean
10101|NCT02026193|Primary|Fetal Heart Activity 1 Month Post Embryo Transfer|Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer|1 month after embryo transfer|||participants with fetal heart activity|||Number
10106|NCT02025907|Secondary|Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26||Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
10107|NCT02025907|Secondary|Percent Change From Baseline in Body Weight at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percent change||Standard Error|Least Squares Mean
10108|NCT02025907|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||millimoles per liter||Standard Error|Least Squares Mean
10109|NCT02025907|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
10110|NCT02025647|Post-Hoc|Mental Health Prevalence Rates Comparison|"What is the percentage of subjects where the provider was unaware of any mental health concerns yet Innerview identified them as having hit a rule out or diagnostic consideration for a mental health disorder vs the US 12 Month Prevalence Rate?~US 12 Month Prevalence Rate = 26.2% (http://www.ncbi.nlm.nih.gov/pubmed/15939839)"|Study Duration|104 subjects had no known mental health concerns||percentage of subjects|||Number
10111|NCT02025647|Other Pre-specified|Completion Times|On average, the number of minutes taken to complete both the narrative and rating modules?|Study Duration|||minutes||Inter-Quartile Range|Median
10112|NCT02025647|Secondary|Subject Survey (Question 10)|It took an acceptable amount of time to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10113|NCT02025647|Secondary|Subject Survey (Question 9)|The demonstration showed me how to use the system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10114|NCT02025647|Secondary|Subject Survey (Question 8)|Telling my story helped me prepare for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10115|NCT02025647|Secondary|Subject Survey (Question 7)|Q7. I would encourage other doctors to use this system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10116|NCT02025647|Secondary|Subject Survey (Question 6)|"I was able to select words and phrases that I normally use to talk about my symptoms.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate|||units on a scale||Standard Deviation|Mean
10117|NCT02025647|Secondary|Subject Survey (Question 5)|The program included all of the symptoms I wanted to share with my doctor. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10118|NCT02025647|Secondary|Subject Survey (Question 4)|This tool will contribute positively to my health care. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10119|NCT02025647|Secondary|Subject Survey (Question 3)|The program was easy to use. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10120|NCT02025647|Secondary|Subject Survey (Question 2)|"Compared to other health care questionnaires I have taken, I would rate this system highly.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate|||units on a scale||Standard Deviation|Mean
10121|NCT02025647|Secondary|Subject Survey (Question 1)|I am satisfied with how I was able to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate|||units on a scale||Standard Deviation|Mean
10122|NCT02025647|Secondary|Provider Survey (Question 11)|On average, how much extra time do you estimate that you spent with your patients evaluating and discussing the information collected through Innerview?|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||minutes||Full Range|Mean
10123|NCT02025647|Secondary|Provider Survey (Question 10)|The benefits of Innerview will outweigh the effort to implement and operate it. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10124|NCT02025647|Secondary|Provider Survey (Question 9)|In my opinion, incorporating Innerview into my practice would require an acceptable amount of time and effort from myself and staff Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10209|NCT02022085|Secondary|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm|Visit 2 (surgery)|Intention-to-Treat (ITT) population; all patients who received surgical intervention.||participants|||Number
10125|NCT02025647|Secondary|Provider Survey (Question 8)|My patients reacted positively to Innerview. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10126|NCT02025647|Secondary|Provider Survey (Question 7)|Innerview will function well within my current work flow Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects, one investigator did not respond to this item.||units on a scale||Full Range|Mean
10127|NCT02025647|Secondary|Provider Survey (Question 6)|"Innerview will help me better identify patients who suffer from a mental health concern.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10128|NCT02025647|Secondary|Provider Survey (Question 5)|"In my opinion, the Innerview narrative process will help prepare patients for treatment.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10129|NCT02025647|Secondary|Provider Survey (Question 4)|The information provided by Innerview was well communicated in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10130|NCT02025647|Secondary|Provider Survey (Question 3)|The information provided by Innerview was well organized in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10131|NCT02025647|Secondary|Provider Survey (Question 2)|"The information provided by Innerview was consistent with my previous observations of my patients.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10132|NCT02025647|Secondary|Provider Survey (Question 1)|"The information provided by Innerview is valuable in understanding and treating my patients.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.||units on a scale||Full Range|Mean
10133|NCT02025647|Primary|Standard Error of Measure for the Individualized Rating Scale (Rating Module)|What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale|approximate 5 minutes between ratings|||units on a scale|||Number
10134|NCT02025647|Primary|Reliability of the Narrative Module|What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?|24-48 hours|||percentage of agreement||Standard Deviation|Mean
10135|NCT02025647|Primary|Accuracy of the Narrative Module|Out of 139 subjects using Innerview for the first time, how many subjects approved their initial version of their narrative versus chose to start over?|Immediate|||participants|||Number
10136|NCT02024971|Secondary|Change From Baseline in Fasting Insulin|Tabulation of fasting insulin test values and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).||μU/dL||Standard Deviation|Mean
10137|NCT02024971|Secondary|Change From Baseline in Fasting Blood Glucose|Tabulation of fasting blood glucose test values and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).||mg/dL||Standard Deviation|Mean
10138|NCT02024971|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of the HbA1c test value and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).||percentage of HbA1c||Standard Deviation|Mean
10210|NCT02022085|Secondary|Time to Perform Surgery|Time of first incision to time of last suture|Visit 2 (Surgery)|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||Minutes||Standard Deviation|Mean
10139|NCT02024971|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety Analysis Set, all patients for whom data was collected in case report forms, except those who were treated before the contract period, those who were enrolled after Day 15 of the start of treatment with Metact Combination Tablets, and those with missing data after treatment (missed visits).||participants|||Number
10140|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage|||participants|||Number
10141|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage|||participants|||Number
10142|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage|||participants|||Number
10143|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage|||participants|||Number
10144|NCT02024867|Secondary|Recurrent Skin Infections|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage|||participants|||Number
10145|NCT02024867|Primary|Treatment Failures|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage|||participants|||Number
10146|NCT02024698|Primary|Overall Satisfaction for Lens|"Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall? (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||participants|||Number
10147|NCT02024698|Primary|Overall Sensation of Smoothness (Subjective Assessment)|"Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear? (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||participants|||Number
10148|NCT02024698|Primary|Eye Whiteness/Redness (Subjective Assessment)|Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
10149|NCT02024698|Primary|Handling (Subjective Assessment)|Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
10150|NCT02024698|Primary|Dryness (Subjective Assessment)|Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
10151|NCT02024698|Primary|Vision Satisfaction (Subjective Assessment)|Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
10152|NCT02024698|Primary|Vision Quality (Subjective Assessment)|Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)|Baseline|||units on a scale||Standard Deviation|Mean
10153|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
10154|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|Baseline|||units on a scale||Standard Deviation|Mean
10806|NCT02004236|Secondary|Commission Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||number of errors during ECPT task||Standard Deviation|Mean
10155|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.||units on a scale||Standard Deviation|Mean
10156|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|Baseline|||units on a scale||Standard Deviation|Mean
10157|NCT02024165|Primary|Fetal Heart Rate Interpretability|The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices|2 hours|||percentage of time the signals are inter||Standard Deviation|Mean
10158|NCT02023801|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 months|Protocol Intent-to-treat||participants|||Number
10159|NCT02023801|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal|< 1 hour|Subjects completing treatment||Minutes||Standard Deviation|Mean
10160|NCT02023801|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)||participants|||Number
10161|NCT02023268|Primary|Global Ocular Staining (With Oxford Scale - Ranges : 0-15)|"Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)~Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed)."|Baseline and Day 35|14 patients with major protocol deviations were excluded of the analysed population.||score on a scale||Standard Deviation|Mean
10162|NCT02023125|Secondary|Vz/F for Alectinib: Group 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||Liters||Standard Deviation|Mean
10163|NCT02023125|Secondary|Apparent Volume of Distribution (Vz/F) for Alectinib: Group 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||Liters||Standard Deviation|Mean
10164|NCT02023125|Secondary|CL/F for Alectinib: Group 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||L/h||Standard Deviation|Mean
10165|NCT02023125|Secondary|Apparent Oral Clearance (CL/F) for Alectinib: Group 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||Liters per hour (L/h)||Standard Deviation|Mean
10166|NCT02023125|Secondary|t1/2 of RO5468924: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Standard Deviation|Mean
10167|NCT02023125|Secondary|t1/2 of RO5468924: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Group 1]||hours||Standard Deviation|Mean
10168|NCT02023125|Secondary|t1/2 of Alectinib: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Standard Deviation|Mean
10169|NCT02023125|Secondary|Terminal Half-life (t1/2) of Alectinib: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours||Standard Deviation|Mean
10170|NCT02023125|Secondary|Tmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Full Range|Median
10171|NCT02023125|Secondary|Tmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours||Full Range|Median
10172|NCT02023125|Secondary|Tmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||hours||Full Range|Median
10173|NCT02023125|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours||Full Range|Median
10174|NCT02023125|Secondary|AUClast of RO5468924: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
10175|NCT02023125|Secondary|AUClast of RO5468924: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||h*ng/mL||Standard Deviation|Mean
10176|NCT02023125|Secondary|AUClast of Alectinib: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
10177|NCT02023125|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||h*ng/mL||Standard Deviation|Mean
10178|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||ratio||Standard Deviation|Geometric Mean
10179|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||ratio||Standard Deviation|Geometric Mean
10180|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
10181|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||h*ng/mL||Standard Deviation|Mean
10182|NCT02023125|Secondary|Cmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||ng/mL||Standard Deviation|Mean
10183|NCT02023125|Secondary|Cmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||ng/mL||Standard Deviation|Mean
10184|NCT02023125|Primary|AUC0-inf of Alectinib: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]||h*ng/mL||Standard Deviation|Mean
10185|NCT02023125|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Alectinib: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
10186|NCT02023125|Primary|Cmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||ng/mL||Standard Deviation|Mean
10187|NCT02023125|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|Pharmacokinetic (PK) Analysis Population [Group 1] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
10188|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse Within Different Subpopulations|"The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm."|within 12 weeks after the last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation.||percentage of participants|||Number
10189|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations|"The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment)."|12 or 16 weeks (end of treatment period)|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.||percentage of participants|||Number
10190|NCT02023112|Secondary|Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations|The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.|12 weeks after last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.||percentage of participants||95% Confidence Interval|Number
10191|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse|Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.|within 12 weeks after the last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug) with HCV RNA < LLOQ at the final treatment visit who completed treatment.||percentage of participants|||Number
10192|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period|On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).|12 or 16 weeks (end of treatment period)|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
10193|NCT02023112|Primary|Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug).||percentage of participants|||Number
10194|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA < 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A); n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).||percentage of participants||95% Confidence Interval|Number
10195|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).||percentage of participants||95% Confidence Interval|Number
10196|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation|"Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT.~Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method."|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).||percentage of participants||95% Confidence Interval|Number
10211|NCT02022085|Secondary|Speech, Spatial and Qualities of Hearing Scale (SSQ)|"Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pe-operative unaided situation. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing."|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.||units on scale||Standard Deviation|Mean
10807|NCT02004236|Secondary|Ommision Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||12/2016||||
10197|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Post-treatment Relapse|Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method.|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).||percentage of participants||95% Confidence Interval|Number
10198|NCT02023099|Secondary|Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation|On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method.|up to 12 weeks|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A).||percentage of participants||95% Confidence Interval|Number
10199|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment|"On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following:~confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point during treatment after HCV RNA < LLOQ (rebound), or~confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during treatment (rebound), or~HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment (failure to suppress).~The 95% confidence interval was calculated using the Wilson's score method."|up to 12 weeks|Intent-to-treat (ITT) population: randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).||percentage of participants||95% Confidence Interval|Number
10200|NCT02023099|Primary|Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment|The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution.|12 weeks after the last dose of study drug|Primary Efficacy Population: randomized non-cirrhotic treatment-naïve participants who are eligible for interferon-based therapy and who have high viral load and received at least one dose of double-blind ABT-450/r/ABT-267.||percentage of participants||95% Confidence Interval|Number
10201|NCT02022670|Secondary|Baseline and Week 10 Aortic Pulse Wave Velocity||Baseline (Week 0), Week 10|||cm/sec||Standard Error|Mean
10202|NCT02022670|Secondary|Baseline and Week 10 Plasma Nitrite Concentrations||Baseline (Week 0), Week 10|||micromolar||Standard Error|Mean
10203|NCT02022670|Primary|Baseline and Week 10 Flow-Mediated Dilation|Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.|Baseline (Week 0), Week 10|||%Change||Standard Error|Mean
10204|NCT02022085|Secondary|Numbness|Degree of numbness when tested with a pin|Day 10, Week 4, Week 6, Week 12, Month 6|Safety population; includes all patients who received the surgical intervention.||percentage of total polulation|||Number
10205|NCT02022085|Secondary|Pain|Degree of pain and discomfort.|Week 6, Week 12, Month 6|Safety population; includes all patients who received the surgical intervention.||percentage of total population|||Number
10206|NCT02022085|Secondary|Sound Processor Magnet Choice|To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.|4, 6, 12 weeks, 6 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6 one patient had left the study.||participants|||Number
10207|NCT02022085|Secondary|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|4, 6, 12 weeks, 6 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention.||Newton||Standard Deviation|Mean
10208|NCT02022085|Secondary|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability|Visit 2 (surgery)|Intention-to-treat (ITT) population; includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
12663|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
10212|NCT02022085|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pe-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||units on scale||Standard Deviation|Mean
10213|NCT02022085|Secondary|Health Utility Index (HUI)|Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||units on a scale||Standard Deviation|Mean
10214|NCT02022085|Secondary|Speech in Quiet, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||Change of % correct words at the dB leve||Standard Deviation|Mean
10215|NCT02022085|Secondary|Adaptive Speech Recognition in Noise, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive speech recognition in noise measured as signal to noise ratio|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.||dB||Standard Deviation|Mean
10216|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry Individual Frequencies, Sound Processor on Softband Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a softband before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies"|Baseline before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
10217|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry PTA4, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
10218|NCT02022085|Secondary|Speech in Quiet, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.||Change of % correct words at the dB leve||Standard Deviation|Mean
10219|NCT02022085|Secondary|Adaptive Speech Recognition in Noise, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.||dB||Standard Deviation|Mean
10220|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry Individual Frequencies, Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies"|Baseline before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
10221|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 24 months after surgery||||||
10222|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 12 months after surgery||||||
10223|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) at 6 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.||dB||Standard Deviation|Mean
10224|NCT02022020|Primary|Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation|Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).||Percentage of participants|||Number
10225|NCT02022020|Primary|Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge|Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).||Percentage of participants|||Number
10226|NCT02022020|Primary|Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge|"Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release.~Emergency Department/Room (ED/ER).~Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:~Ongoing, if symptoms of bleeding not completely resolved at time of discharge;~Deceased in case of death;~Resolved otherwise."|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).||Percentage of participants|||Number
10227|NCT02021461|Primary|Assessment of Taste Preference|Subject preference for 3 flavours of the ESL oral suspension was assessed based on a measured score using a 0-10 cm (minimum and maximum measured values) Visual Analogue Scale (VAS). Higher values represent the stronger preference.|single Study Day|||units on a scale (0-10 cm VAS)||Standard Deviation|Mean
10228|NCT02021071|Secondary|Fluoroscopy Time|Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone.|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest|||Minutes||Full Range|Median
10229|NCT02021071|Primary|System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness|"Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures.~The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability.~The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average"|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest|SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning)||Scores on a scale||Standard Deviation|Mean
10230|NCT02020941|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Up to 30 days after completion of study treatment, up to 2 years|All patients enrolled and received treatment.||participants|||Number
10231|NCT02020941|Secondary|Duration of Response (DOR)|Analysis will be performed using Kaplan-Meier estimates. Time from date of first confirmed response of partial response or better to date of progression or death. Only patients who had a response of partial response or better will be included in this analysis.|Time from first evidence of PR or better to disease progression or death, assessed up to 2 years|All patients who had a response of partial response or better||months||95% Confidence Interval|Median
10232|NCT02020941|Secondary|Time to Progression (TTP)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression. The observations of patients who died or remained alive and progression free were censored at date of death or last disease evaluation, respectively.|Time from first dose to disease progression, assessed up to 2 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
10233|NCT02020941|Secondary|Progression-free Survival (PFS)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at date of last disease evaluation.|Time from first dose to first observed disease progression or death, assessed up to 2 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
10234|NCT02020941|Secondary|Overall Response Rate (ORR) After 4 Courses of Treatment|Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 16 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit||percentage of participants||95% Confidence Interval|Number
10235|NCT02020941|Primary|Overall Response Rate (ORR) After 8 Courses of Treatment|: Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 32 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit||percentage of participants||95% Confidence Interval|Number
10236|NCT02020863|Primary|Fluid Status During Surgery|The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.|Duration of Surgery, up to 8 hours|Closed Loop Study population at Stroke Volume Variation (SVV) ≤12%||percentage of case time||Standard Deviation|Mean
10237|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Cetuximab).|Maximum Tolerated Dose (MTD) of cetuximab based on DLTs during the first treatment cycle (Dose escalation part).|First treatment cycle|Dose finding cohort treated set||mg/m2|||Number
10238|NCT02020577|Primary|Dose Limiting Toxicities|Number of Patients With Dose Limiting Toxicity (DLT) Occurring During Cycle 1.|First 21-day treatment cycle|Dose finding cohort treated set||Participants|||Number
10239|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).|Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on DLTs during the first treatment cycle (Dose escalation part). The MTD is defined as the highest dose level at which less than 33% of the patients experience DLT in first treatment cycle.|First treatment cycle|Dose finding cohort treated set: This patient set includes all patients enrolled in part A of the trial who were documented to have taken at least one dose of study medication.||mg|||Number
10240|NCT02020512|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 5|Intent-to-Treat: all treated patients||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
10241|NCT02020031|Primary|Mean Concentration of Vancomycin in Bone Samples|During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|baseline to 24 hours|||µg/g||Standard Deviation|Mean
10242|NCT02020031|Primary|Mean Concentration of Vancomycin in Subcutaneous Fat|During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|Baseline to 24 hours|||µg/g||Standard Deviation|Mean
10243|NCT02019563|Secondary|MTA/FS Pulpotomy and RCT Treated Incisor Survival|Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups. One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations. The log-rank test was used to statistically compare survival of incisors.|12 and 18 months|Four participants in the MTA/FS and two participants in the RCT group did not have data collected due to lost to follow-up. Remaining participants were censored if lost to follow-up, exfoliated, lost to trauma or had a non-occurrence of a failure before the trial end.||Proportion of participants|||Number
10244|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.|18 months after the procedure|||Proportion of incisors|Participants||Number
10245|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes. Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher’s Exact test.|12 months after the procedure|||Proportion of incisors|Participants||Number
10246|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|18 months after the procedure|||Proportion of incisors|Participants||Number
10247|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|12 months after the procedure|||Proportion of incisors|Participants||Number
10248|NCT02017574|Secondary|EEG Derived High Alpha Power|Brain electrophysiology measure of attentional processes as indexed by high alpha power (10-13 Hz). The unit of measurement is a percentage as the amount of power (microvolts squared) in the high alpha band was divided by the total power in the spectrum (i.e. 1-50 Hz). This method is commonly employed to normalize the power of a particular frequency if the statistical design includes a between subjects factor.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.||percentage of the total power||Standard Error|Mean
10249|NCT02017574|Primary|Quality of Motor Performance|Quality of motor behavior was indexed by the percentage of samples in which the participants were within the trained (i.e. optimal) trajectory. The trained trajectory was a 2cm wide channel in the shape of a half circle between two targets which were 25cm apart from each other. Therefore, the scale measure is a percentage which can range between 0 and 100%.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.||percentage of samples not 'on' task||Standard Deviation|Mean
10250|NCT02017093|Primary|Fugl-Meyer Assessment Score|The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.|The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).|||units on a scale||Standard Deviation|Mean
10251|NCT02017093|Primary|Improvement in Average Movement Trajectory Error From T1 to T2|While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.|The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).|||cm||Standard Deviation|Mean
10252|NCT02017015|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time from the date of first treatment to the date of death. Participants who did not die at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cut-off date, whichever was earlier.|From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks|ITT population includes all enrolled participants||months||95% Confidence Interval|Median
10808|NCT02004236|Secondary|Reaction Time After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||Milliseconds||Standard Deviation|Mean
10253|NCT02017015|Secondary|Duration of Response (DoR) Based on IRR According to RECIST Guidelines|DoR was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion is met to the date of disease progression based on IRR following RECIST 1.0. Only for those participants with a confirmed CR/PR. If a participant had disease progression, then the date of disease progression was the event date. For a participant who did not develop disease progression or disease progression occurred after 2 or more missing tumor assessments, the participant was censored on the date of last tumor assessment where the participant was documented to be progression free. If a participant died prior to disease progression, the participant was censored on the date of death. If patient started new anti-cancer therapy, the patient was censored on the last tumor assessment date on or prior to the start date of new anti-cancer therapy|Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks|Includes participants with a Confirmed Complete or Partial Response||months||95% Confidence Interval|Median
10254|NCT02017015|Primary|Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)|ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) based on independent radiological review per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Using RECIST Version 1.0, participants were to achieve either a complete response defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the independent radiological review of best overall response during study treatment.|Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks|Intent to Treat (ITT) population included all participants enrolled into the study||percentage of participants||95% Confidence Interval|Number
10255|NCT02017015|Secondary|Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as adverse events (AEs) that began or worsened in severity on or after the date of the first dose of study drug and within 30 days of the last dose of study drug. A Serious AE (SAE) = any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect; constitutes an important medical event. Treatment-related AEs (TRAEs) were any TEAEs considered to be related to the study drug. A TRAE is a TEAE with relationship as suspected to either ABI-007 or gemcitabine The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Other AEs not described in the CTCAE criteria, the intensity will be assessed by the investigator as mild grade (Gr 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Study drug initiation through 30 days after the last dose of study drug or End Of Study, whichever is later; maximum treatment duration was 54.9 weeks|Safety population includes all enrolled participants who received at least 1 dose of study drug||participants|||Number
10256|NCT02016963|Secondary|Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose|Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. Serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics|From the date of the dose administration of study agent for this study (Day 0) until Day 56|As-treated population||Micrograms/milliliter (µg/mL)||Standard Deviation|Mean
10257|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10258|NCT02016963|Secondary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10259|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10809|NCT02004236|Secondary|P3b Wave Amplitude Before tRNS|ERP and behaviour Changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
10260|NCT02016963|Secondary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10261|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10262|NCT02016963|Secondary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10263|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10264|NCT02016963|Secondary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10265|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10266|NCT02016963|Secondary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10810|NCT02004236|Secondary|Commission Errors Before tRNS|ERP and Behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions|||number of errors during ECPT task||Standard Deviation|Median
10267|NCT02016963|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population||Participants|||Number
10268|NCT02016963|Primary|Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response|Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population : all participants who received 1 dose of study treatment.||Participants|||Number
10269|NCT02016690|Secondary|Mean Duration of Respiratory Support|The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab|Participants with available data||days||Standard Deviation|Mean
10270|NCT02016690|Secondary|Number of Hospitalized Participants Requiring Respiratory Support|The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab|Participants with available data||Participants|||Count of Participants
10271|NCT02016690|Secondary|Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection|The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab|Participants with available data||days||Standard Deviation|Mean
10272|NCT02016690|Secondary|Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection|Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab|Participants with available data||Participants|||Count of Participants
10273|NCT02016690|Secondary|Change in Lower Respiratory Tract Infection (LRI) Score During the Study|The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab|Participants with available data||units on a scale||Standard Deviation|Mean
10274|NCT02016690|Primary|Number of Participants With Adverse Drug Reactions|"An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: Related, Causality cannot be ruled out, or Not assessable as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: Death, Life-threatening condition, Hospitalization or prolonged hospitalization, Persistent or significant disability, or Other medically important condition. Information about AEs and ADRs was documented on the case report form (CRF)."|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.||Participants|||Count of Participants
10275|NCT02016690|Primary|Number of Participants With Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.||Participants|||Count of Participants
10276|NCT02016690|Primary|Number of Participants With Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.||Participants|||Count of Participants
10277|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10278|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first tac administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10279|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first tac administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10280|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Tac in Plasma)|"Cmax (maximum measured concentration of the tac in plasma).~PK sampling (relative to the first tac administration [h:min]):~Period 1:~for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10281|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the tac in plasma over the time interval from 0 to the last quantifiable point).~PK sampling (relative to the first tac administration [h:min]):~Period 1: for tac~0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h~Period 2 For tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10282|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the tac in plasma over the time interval from 0 extrapolated to infinity).~PK sampling (relative to the first tac administration):~Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h period 2 for tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|pharmacokinetic set of tac (PKS tac): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of tac in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10283|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10284|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10285|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by cyclo treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10633|NCT02009865|Secondary|Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL|This first secondary endpoint in subjects with at least 1 qualifying triglyceride >885 mg/dL was tested in parallel together with the primary endpoint, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
10286|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Cyclo in Plasma)|"Cmax (maximum measured concentration of the cyclo in plasma).~PK sampling (relative to the first cyclo administration [h:min]):~Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10287|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 to the last quantifiable point).~PK sampling (relative to the first cyclo administration [h:min]):~Period 1:~for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS cyclo||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10288|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity).~PK sampling (relative to the first cyclo administration [h:min])~Period 1:~for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h.~period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|pharmacokinetic set of cyclo (PKS cyclo): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of cyclo in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10289|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26|Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10290|NCT02016482|Secondary|Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study|The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.|up to Week 26|ITT Population in Period A: all participants who were randomized at Baseline and did not have PsA at Baseline. Observed cases.||percentage of participants|||Number
10291|NCT02016482|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26|Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with a given assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10292|NCT02016482|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26|The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10293|NCT02016482|Secondary|Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26|The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from –0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10294|NCT02016482|Secondary|Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26|"The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating fingernail psoriasis had no effect on this and 10 indicating fingernail psoriasis completely prevented me from this. A decrease in the WPAI:NPSO score indicates improvement."|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with given assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10295|NCT02016482|Secondary|Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||percentage of participants|||Number
10296|NCT02016482|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10297|NCT02016482|Secondary|Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
10298|NCT02016482|Secondary|Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10299|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.||percent change||Standard Error|Least Squares Mean
10300|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.||percent change||Standard Error|Least Squares Mean
10301|NCT02016482|Secondary|Percent Change From Baseline in Total BSA at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
10302|NCT02016482|Secondary|Change From Baseline in Total Body Surface Area (BSA) at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of affected BSA||Standard Error|Least Squares Mean
10303|NCT02016482|Secondary|Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26|The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had Baseline inverse psoriasis score ≥ 6. Inverse psoriasis was assessed for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.||percentage of participants|||Number
10304|NCT02016482|Secondary|"Percentage of Participants Achieving PGA-S of Clear at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10305|NCT02016482|Secondary|"Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) Clear or Minimal at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) or minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10634|NCT02009865|Primary|Percent Change in Triglyceride for All Subjects|This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|Full Analysis Set (FAS)||Percentage of change (%)||Inter-Quartile Range|Median
10306|NCT02016482|Secondary|Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline PASI score ≥ 5. Multiple imputation.||percentage of participants|||Number
10307|NCT02016482|Secondary|Percent Change From Baseline in PASI Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
10308|NCT02016482|Secondary|Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10309|NCT02016482|Secondary|Change From Baseline in Total Fingernail NAPSI Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10310|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
10311|NCT02016482|Secondary|Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10312|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10313|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10314|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
10315|NCT02016482|Secondary|Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
10316|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percent change||Standard Error|Least Squares Mean
10317|NCT02016482|Secondary|Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||units on a scale||Standard Error|Least Squares Mean
12664|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
10318|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10319|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10320|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10321|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Matrix Component of the PGA-F At Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail matrix component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail matrix component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail matrix component of moderate or worse. Multiple imputations."||percentage of participants|||Number
10322|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Bed Component of the PGA-F at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail bed component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail bed component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail bed component of moderate or worse. Multiple imputation."||percentage of participants|||Number
10323|NCT02016482|Secondary|Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26|The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Scalp psoriasis was assessed by B-SNIPI at Week 26 for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.||percentage of participants|||Number
10324|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.||units on a scale||Standard Error|Least Squares Mean
10325|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.||percent change||Standard Error|Least Squares Mean
10326|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10327|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.||percent change||Standard Error|Least Squares Mean
10328|NCT02016482|Primary|"For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of Clear or Minimal at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of “clear” (0) or “minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.||percentage of participants|||Number
10329|NCT02016482|Primary|Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.|Week 26|Intent-to-treat (ITT) Population in Period A: all participants who were randomized at Baseline.||percentage of participants|||Number
10330|NCT02016170|Secondary|Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP).|The secondary hypothesis of our study was that after 1 week of randomized treatment PRI levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel. VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies.|7 days|||PRI||Standard Deviation|Least Squares Mean
10331|NCT02016170|Primary|Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay|The primary hypothesis of our study was that after 1 week of randomized treatment PRU levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel.|7 days|Analysis was conducted in patients who received the randomized treatment and had a valid primary end point value (PRU at 1 week).||PRU||Standard Error|Least Squares Mean
10332|NCT02015910|Primary|Percent Wounds Healed|Compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.|12 weeks|Data analysis not completed due to insufficient enrollment.|||||
10333|NCT02015793|Other Pre-specified|Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations >2 μg/mL.|Baseline (Week 0) to Week 8|ITT population.|||||
10334|NCT02015793|Secondary|Fecal Calprotectin: Change From Baseline (Week 0) to Week 8|Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.|Baseline (Week 0) and Weeks 4 and 8|ITT population.||μg/g||Full Range|Median
10335|NCT02015793|Secondary|High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26|hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26|ITT population.||mg/L||Full Range|Median
10336|NCT02015793|Secondary|CDAI: Mean Change From Baseline to Each Visit|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.||units on a scale||Standard Deviation|Mean
10337|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.||percentage of participants||95% Confidence Interval|Number
10338|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.||percentage of participants||95% Confidence Interval|Number
10339|NCT02015793|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.~For more details on adverse events please see the AE section below."|35 weeks|Safety Analysis Set.||participants|||Number
10340|NCT02015793|Secondary|Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab|Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively.|26 weeks|Safety Analysis Set.||participants|||Number
10341|NCT02015793|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.|From Week 0 to Week 26|Safety Analysis Set.||participants|||Number
10342|NCT02015793|Secondary|Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|26 weeks|Safety Analysis Set: all participants who received at least 1 dose of study drug.||participants|||Number
10343|NCT02015793|Primary|Mean Serum Adalimumab Concentration at Week 8|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.|Week 8|All participants in the intent-to-treat (ITT) population, defined as all randomized participants who received at least 1 dose of double-blind study drug, who had evaluable data.||μg/mL||Standard Deviation|Mean
10344|NCT02015676|Secondary|Overall Survival|The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||Standard Error|Mean
10345|NCT02015676|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
10346|NCT02015676|Secondary|Time to Therapy Failure|The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
10347|NCT02015676|Secondary|Time to Therapy Failure - Percentage of Participants With an Event|Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
10348|NCT02015676|Secondary|Duration of Response|The median time, in months, from enrollment to duration of response event to Week 52.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
10349|NCT02015676|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|Only participants with a response were included in the analysis.||percentage of participants|||Number
10350|NCT02015676|Secondary|Time to Treatment Response|The median time, in months, from the start of treatment to treatment response event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
10351|NCT02015676|Secondary|Time to Treatment Response - Percentage of Participants With an Event|Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage participants|||Number
10352|NCT02015676|Secondary|Time to Disease Progression|The median time, in months, from the start of treatment to disease progression event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||months||95% Confidence Interval|Median
10353|NCT02015676|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
10354|NCT02015676|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment|For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.|Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.||percentage of participants|||Number
10355|NCT02015546|Secondary|MADRS Remission|MADRS remission is defined as MADRS score < 10|Week 8|||participants|||Number
10356|NCT02015546|Secondary|MADRS Response|Number of subjects who had a ≥ 50% decrease in MADRS score from baseline|Baseline, Week 8|||participants|||Number
10357|NCT02015546|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, 8 week|||units on a scale||Standard Deviation|Mean
10358|NCT02015546|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Baseline, Week 8|||units on a scale||Standard Deviation|Mean
10359|NCT02015546|Secondary|Change in Sheehan Disability Scale (SDS)|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline, 8 week|||units on a scale||Standard Deviation|Mean
10360|NCT02015546|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks|||units on a scale||Standard Deviation|Mean
10361|NCT02015546|Primary|Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Baseline, Weeks 8|||units on a scale||Standard Deviation|Mean
10362|NCT02015546|Primary|Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary.~Total possible range is 0 to 172. A higher score indicates more symptoms."|Baseline, week 9|||units on a scale||Standard Deviation|Mean
10363|NCT02015546|Primary|Change in Total MADRS Scores From Baseline to Week 8|The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline, Week 8|||units on a scale||Standard Deviation|Mean
10364|NCT02015221|Primary|Ease of Use and Comfort for Subjects Using the ACTitouch System.|Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.|30 days|||Percent of participants|Participants|95% Confidence Interval|Number
10365|NCT02015195|Primary|Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours|"Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with 0 representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a scale from -20 to +20 with 0 being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the treatment arm was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20)."|30 minutes, 1 hour, and 24 hours|||units on a scale||95% Confidence Interval|Mean
10366|NCT02015195|Primary|Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours|"Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The mean change for the treatment arm was then compared with the mean change for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group."|24 hours|one participant excluded because of adverse local skin reaction to household ammonia||units on a scale||95% Confidence Interval|Mean
10374|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Volume at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle volume was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Femtoliter (FL)||Standard Deviation|Mean
10635|NCT02009722|Secondary|Treatment for Pruritus|The number of patients needing medical treatment for pruritus in first 24 hours after surgery|First 24 hours after spinal|only patients receiving most commonly used doses of IT hydromorphone (50,75,100 mcg) and morphine (100,150 mcg)||participants|||Number
10367|NCT02014480|Secondary|Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 81)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
10368|NCT02014480|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 85)|ITT Population. Only those participants available at the indicated time point were assessed.||participants|||Number
10369|NCT02014480|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC or, VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.’s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 66)|ITT Population||participants|||Number
10370|NCT02014480|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP.|Baseline and Day 14 of each treatment period (up to study day 85)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
10371|NCT02014467|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, serious non-fatal AEs, serious fatal AEs have been presented.|From start of IP through the Study Phase (6 months post-dose) (assessed up to 12 months)|Safety Population. Two participants randomized to placebo group received denosumab by mistake.||Participants|||Number
10372|NCT02014467|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Baseline and Month 12|Anti-denosumab antibody formation was assessed at Baseline (Visit 3) and Month 12. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody.|Baseline and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
10373|NCT02014467|Secondary|Change From Baseline in Red Blood Cell Count at Month 6 and Month 12|Baseline value was obtained at screening (visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as: Value at Indicated visit minus Baseline value. Blood samples were collected for measurement. Red blood cell count was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Trillion cells per liter (TI/L)||Standard Deviation|Mean
10375|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle hemoglobin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Picograms (PG)||Standard Deviation|Mean
10376|NCT02014467|Secondary|Change From Baseline in Hematocrit at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Hematocrit was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Ratio||Standard Deviation|Mean
10377|NCT02014467|Secondary|Change From Baseline in Creatinine and Uric Acid at Month 6 and Month 12|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatinine and uric acid were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
10378|NCT02014467|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Direct bilirubin and total bilirubin were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
10379|NCT02014467|Secondary|Change From Baseline in Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen (BUN) at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Chloride, cholesterol, glucose, magnesium, inorganic phosphorous, potassium, sodium, triglycerides and urea/BUN were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
10380|NCT02014467|Secondary|Change From Baseline in Calcium (Corrected), Calcium at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Calcium (corrected) and calcium were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
10381|NCT02014467|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils-total Absolute Neutrophil Count (ANC), White Blood Cell Count at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils-total ANC and white blood cell count were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Giga per liter (GI/L)||Standard Deviation|Mean
10382|NCT02014467|Secondary|Change From Baseline in Hemoglobin and Total Protein at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Hemoglobin and total protein were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Grams per liter (G/L)||Standard Deviation|Mean
10383|NCT02014467|Secondary|Change From Baseline in Globulin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Globulin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Grams per liter (G/L)||Standard Deviation|Mean
10384|NCT02014467|Secondary|Change From Baseline in Albumin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Albumin was assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Gram per liter (G/L)||Standard Deviation|Mean
10385|NCT02014467|Secondary|Change From Baseline in Creatine Kinase, Lactate Dehydrogenase at Month 6 and Month 12.|Baseline values was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatine kinase and lactate dehydrogenase were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||International unit per liter (IU/L)||Standard Deviation|Mean
10386|NCT02014467|Secondary|Change From Baseline in Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Month 1, Month 6 and Month 12|Baseline values were obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Alanine amino transferase, alkaline phosphatase, aspartate amino transferase, and gamma glutamyl transferase were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6, and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||International unit per liter (IU/L)||Standard Deviation|Mean
10387|NCT02014467|Secondary|Change From Baseline in Heart Rate at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in heart rate was assessed at Baseline, Month 1, Month 3, Month 6 and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Beats per minute||Standard Deviation|Mean
10388|NCT02014467|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in SBP and DBP was assessed at Baseline, Month 1, Month 3, Month 6, and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population: all participants who received at least one dose of study medication. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Millimeters of mercury (mmHg)||Standard Deviation|Mean
10389|NCT02014467|Secondary|Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline to Month 6 and Month 12|s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in serum CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6, Month 12|ITT Population: Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).||Percentage change||Inter-Quartile Range|Median
10390|NCT02014467|Secondary|Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline to Month 6 and Month 12|s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in s-CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6 and Month 12|ITT Population. Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).||Percentage change||Inter-Quartile Range|Median
10391|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10392|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10636|NCT02009722|Secondary|Treatment for Nausea|number of patients needing medication treatment for nausea in first 24 hours|First 24 hours|patients receiving most commonly used doses of IT medication (50,75,100 mcg for hydromorphone; 100, 150 mcg for morphine)||participants|||Number
10393|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10394|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10395|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10396|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10397|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Lumbar Spine at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10398|NCT02014467|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12|Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|Intent-to-Treat (ITT) Population: all safety Population participants (consisting of all participants who received at least one dose of study medication) who had a Baseline and at least one valid post-Baseline efficacy measure. Participants with values at Baseline and Month 12 were included in the analysis.||Percentage change||Standard Error|Least Squares Mean
10408|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment.||percentage of participants|||Number
10811|NCT02004236|Secondary|Omission Errors Before tRNS|ERP and behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions|||number of errors during ECPT task||Standard Deviation|Mean
10399|NCT02014441|Secondary|Number of Participants With Adverse Events (AEs)|The Common Terminology Criteria for Adverse Events version 3.0 was used to grade severity of adverse events, based on the following general guideline: Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. A serious adverse event was defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event Treatment-related adverse events (TRAEs) are defined as adverse events possibly caused by talimogene laherparepvec, as assessed by the investigator.|From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median treatment duration was 21.1 weeks.|All participants who received at least 1 dose of talimogene laherparepvec.||participants|||Number
10400|NCT02014441|Secondary|Overall Survival|Overall Survival (OS) was defined as the interval from first dose of talimogene laherparepvec to death from any cause; participants still alive were censored at the last known alive date.|From first dose of talimogene laherparepvec up to the data cut-off date. The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||months||95% Confidence Interval|Median
10401|NCT02014441|Secondary|Durable Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Durable response rate is defined as the percentage of participants with a complete response or partial response maintained continuously for at least 6 months (183 days).~Complete response: disappearance of all index and non-index lesions. Partial Response:≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||percentage of participants||95% Confidence Interval|Number
10402|NCT02014441|Secondary|Duration of Response|Duration of response (DOR) was calculated only for those participants with an objective response and defined as the longest interval from an initial objective response (complete response or partial response) to disease progression per the modified WHO criteria or death, whichever occurred earlier; otherwise, DOR was censored at the last evaluable tumor assessment for participants who did not die or progress.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec and had an objective response.||months||95% Confidence Interval|Median
10403|NCT02014441|Secondary|Time to Response|Time to response was defined as the interval from the first dose of talimogene laherparepvec to the first event of complete response or partial response per modified WHO criteria; participants who did not respond were censored at the last evaluable tumor assessment.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||months||95% Confidence Interval|Median
10404|NCT02014441|Secondary|Objective Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Objective response rate is defined as the percentage of participants with either a complete response or partial response. Subsequent confirmation was not required.~Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and thenat least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||percentage of participants||95% Confidence Interval|Number
10405|NCT02014441|Secondary|Best Overall Response|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound of the chest, abdomen, and pelvis and all other sites of disease).~Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions.~Stable disease: Neither sufficient tumor shrinkage of index lesion to qualify for response nor sufficient tumor increase of index lesion to qualify for progressive disease, assessed a minimum interval of 77 days from the first dose of study drug.~Progressive Disease: ≥ 25% increase in size of index lesions or appearance of one or more non-index lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.||participants|||Number
10406|NCT02014441|Secondary|Number of Samples With Detectable Talimogene Laherparepvec in Lesions Suspected to be Herpetic in Origin|Any lesion such as a cold sore or vesicle thought to be herpetic in origin was evaluated by the investigator and swabbed if HSV infection was suspected. Quantitative PCR was performed on the swab sample to evaluate whether talimogene laherparepvec DNA was detectable in the sample.|From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions suspected to be herpetic in origin during the study.||samples|samples||Number
10407|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.|||||
10409|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.|||samples||
10410|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after end of treatment.||percentage of samples|samples||Number
10411|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa after the end of treatment treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.|||||
10412|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs taken from oral mucosa after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.||percentage of participants|||Number
10413|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.|||samples||
10414|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.||percentage of samples|samples||Number
10415|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. Results for TCID50 for swabs of the anogenital area were not available as of the data cutoff date.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.|||||
10416|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.||percentage of participants|||Number
10417|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. Results for TCID50 for swabs of the anogenital area were not available as of the data cutoff date.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.|||samples||
10418|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA at any time during treatment (cycles 1 - 37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.||percentage of samples|samples||Number
10437|NCT02014272|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.||hour||Full Range|Median
10419|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.||percentage of participants|||Number
10420|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.||percentage of participants|||Number
10421|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus at any time during treatment (cycles 1-37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.||percentage of samples|samples||Number
10422|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA at any time during treatment (cycles 1 - 37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.||percentage of samples|Samples||Number
10423|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Surface of Injected Lesions|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.||percentage of participants|||Number
10424|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Surface of Injected Lesions|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.||percentage of participants|||Number
10425|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec Virus|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from the surface of injected lesions with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.||percentage of samples|samples||Number
10426|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the surface of injected lesions with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.||percentage of samples|Samples||Number
10427|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.||percentage of participants|||Number
10450|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants Progression-free at 12 Months|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.||percentage of participants||95% Confidence Interval|Number
10428|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.||percentage of participants|||Number
10429|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.||percentage of samples|samples||Number
10430|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.||percentage of samples|samples||Number
10431|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine|A participant was defined as having cleared talimogene laherparepvec if a negative urine sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose urine samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.||percentage of participants||95% Confidence Interval|Number
10432|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood|A participant was defined as having cleared talimogene laherparepvec if a negative blood sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants must have received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose blood samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.||percentage of participants||95% Confidence Interval|Number
10433|NCT02014441|Primary|Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least 1 dose of talimogene laherparepvec, and had at least 1 postdose blood/urine sample collected.||percentage of participants||95% Confidence Interval|Number
10434|NCT02014363|Primary|Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment.|The mean difference in baseline-adjusted MADRS score at the end of treatment in the per protocol population using the last observation carried forward (LOCF) method. MADRS is used to assess the range of symptoms that are most frequently observed in patients with major depression. The MADRS test includes 10 items and uses a 0 to 6 severity scale, with higher scores indicating increasing depressive symptoms. The total MADRS score is derived by adding all the scores from the 10 items, meaning the lowest possible score is 0 and the highest possible is 60.|Baseline (start of randomized treatment) and 8 weeks post start of treatment|Per protocol population (all subjects of the full analysis set for whom no relevant protocol deviations were documented).||Scores on a scale||Standard Error|Least Squares Mean
10435|NCT02014272|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/ greater than [>] 1.5*limit of reference range [LRR]); platelets (<0.5/>1.75*LRR); neutrophils, lymphocytes (<0.8/>1.2*LRR); eosinophils, basophils, monocytes (>1.2*upper LN [ULN]); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN); creatinine, urea (>1.3*ULN); fasting glucose (<0.6 />1.5*LRR); uric acid (>1.2*ULN); sodium (<0.95/>1.05*LRR); potassium, calcium, chloride, bicarbonate (<0.9/>1.1*LRR); albumin, total protein (<0.8/>1.2*LRR); creatine kinase (>2.0*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs) (>=20 high-powered field). Total number of participants with any laboratory abnormalities was reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
10436|NCT02014272|Other Pre-specified|Number of Participants With Clinically Significant Changes in Vital Signs|Criteria for clinical significant change in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or greater than (>) 120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum change from baseline in systolic BP >=30 mmHg, maximum change from baseline in diastolic BP >=20 mmHg. Participants who met the criteria were reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication.||participants|||Number
10438|NCT02014272|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half life (t1/2) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable t½ values, respectively.||hour||Standard Deviation|Mean
10439|NCT02014272|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) was reported for rifampicin and isoniazid. It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable AUC (0 - ∞) values, respectively.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
10440|NCT02014272|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10441|NCT02014272|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.||(nanogram*hour) per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
10442|NCT02014051|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 18 weeks||||||Number
10443|NCT02014051|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)|"Definition~Hematologic Improvement Erythrocyte (HI-E):~Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation~Hematologic Improvement Platelet (HI-P):~Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%~Hematologic Improvement Neutrophil (HI-N):~At least 100% increase and an absolute increase > 0.5×10^9/L~Progressive disease / Relapse:~At least 1 of the following:~At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 18 weeks|||participants|||Number
10444|NCT02014051|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)|"Definition~Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%~Partial remission (PR) Same as CR except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%~Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR~Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 weeks Disease progression~Patients with:~Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts~Any of the following:~At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks|||participants|||Number
10445|NCT02014051|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 1. DLTs were also assessed in the Efficacy and Safety Assessment Committee.~Criteria~Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhoea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhoea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)~Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 21 days|||participants|||Number
10446|NCT02014051|Primary|Adverse Events|Total Number Affected by Any Adverse Event (Details are presented in Adverse Event section)|Up to 18 weeks|||participants|||Number
10447|NCT02013830|Secondary|Overall Survival - Percentage of Participants Event Free at 12 Months|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.||percentage of participants||95% Confidence Interval|Number
10448|NCT02013830|Secondary|Overall Survival|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT Population.||months||95% Confidence Interval|Median
10449|NCT02013830|Secondary|Overall Survival - Percentage of Participants With an Event|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.||percentage of participants|||Number
10812|NCT02004236|Secondary|Reaction Time in ECPT Before tRNS|ERP & Behaviour changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||Milliseconds||Standard Deviation|Mean
10451|NCT02013830|Secondary|Time to Disease Progression|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Intent-To-Treat (ITT) Population included all enrolled participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
10452|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|ITT population.||percentage of participants|||Number
10453|NCT02013830|Secondary|Percentage of Participants With Disease Control|The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|PP population.||percentage of participants||95% Confidence Interval|Number
10454|NCT02013830|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Per Protocol (PP) Population included participants who: received greater than or equal to (≥) 1 dose of study medication, ≥6 weeks of treatment (unless excluded for allowed reasons), did not severely violate inclusion/exclusion criteria, had tumor assessment, greater than (>) 50% of first 6 weeks of treatment, and were not replaced.||percentage of participants||95% Confidence Interval|Number
10455|NCT02013817|Secondary|Percentage of Participants With Adverse Events (AEs)|AEs were recorded from the date of first medication administration until 28 days after the last trial medication.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.|ITT population||percentage of participants|||Number
10456|NCT02013817|Secondary|Time to Next Treatment - Time to Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months|||days||Standard Deviation|Mean
10457|NCT02013817|Secondary|Time to Next Treatment - Percentage of Participants With an Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months|||percentage of participants|||Number
10458|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population||percentage of participants||95% Confidence Interval|Number
10459|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population||percentage of participants||95% Confidence Interval|Number
10480|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||milliseconds||Standard Deviation|Mean
12665|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
10460|NCT02013817|Primary|Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)|Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
10461|NCT02013765|Primary|Percentage of Participants Progression Free at 12 and 24 Months||Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
10462|NCT02013765|Secondary|Percentage of Participants by Best Overall Response to Treatment|Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD).|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS||percentage of participants|||Number
10463|NCT02013765|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first study drug treatment to a PFS event.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS||months||95% Confidence Interval|Median
10464|NCT02013765|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
10465|NCT02013765|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to an OS event.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS||months||95% Confidence Interval|Median
10466|NCT02013765|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS||percentage of participants|||Number
10467|NCT02013765|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS||percentage of participants|||Number
10468|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), showing ≥80% reduction of oocysts in Anopheles mosquito gut in ≥50% of the subjects with Study Day 196 sera (one month after the third vaccination) (Study Day 196) in either the 30 μg or 100 μg dose groups.|196 days|||% TRA||95% Confidence Interval|Mean
10469|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.|84 days|||% TRA||95% Confidence Interval|Mean
10470|NCT02013687|Secondary|Assessment of Anti-Pfs25 IgG Following the Third Immunization.|Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.|196 days|||Antibody Titer||95% Confidence Interval|Geometric Mean
10471|NCT02013687|Primary|Subjects With Solicited Local Adverse Events||336 days|||Participants|||Count of Participants
10472|NCT02013687|Primary|Subjects With Solicited Systemic Adverse Events||336 days|||Participants|||Count of Participants
10473|NCT02013687|Primary|Subjects With at Least One Adverse Event||336 days|||Participants|||Count of Participants
10474|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. It took 10 to 15 minutes to complete the BIS-11. The BIS-11 was administered at the following visits: Baseline and Week 16/ET.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10481|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||failures||Standard Deviation|Mean
10637|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
10475|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10476|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10477|NCT02013622|Secondary|Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Number of Impulsive Choices||Standard Deviation|Mean
10478|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores|Delay discounting measures the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ with completion of an Experiential Discounting task (EDT). The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher Probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10479|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10580|NCT02010684|Secondary|Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months|The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
10482|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score|The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). The effectiveness domain was rated on a 7-point scale from “extremely satisfied” to “extremely dissatisfied.” The side effects domain provided an option to skip questions 5 to 8 if the subject provided a negative response to item number 4, ie, “As a result of taking this medication, do you currently experience any side effects at all?” Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10483|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI was a self-rated questionnaire that assessed sleep quality and disturbances over a 1-month time interval. Seven domains were measured: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if 1 is available). Only self-rated questions are included in the scoring.The 19 self-rated items are combined to form 7 “component” scores, each of which has a range of 0 - 3 points. In all cases, a score of “0” indicates no difficulty, while a score of “3” indicates severe difficulty. The 7 component scores are then added to yield 1 “global” score, with a range of 0 - 21 points, “0” indicating no difficulty and “21” indicating severe difficulties in all areas.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10484|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score|The SLOF questionnaire used in this trial consists of 30 items grouped into 4 areas: social functioning, social acceptability, activities, and work skill. The SLOF scale correlates with a participant's quality of life. Total SLOF scale is sum of these 4 areas score. Each of the questions in the above domains is rated on a 5-point Likert scale. Scores on the instrument range from 30 to 150 with higher scores indicating the better the overall functioning of the patient.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10485|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score|The PSP was used to measure personal and social functioning in 4 domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the study physician's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees, and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10486|NCT02013622|Secondary|CGI-I Response Rate|The CGI-I response rate was defined as percentage of participants with CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 4, 8, 12, and 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||percentage of participants|||Number
10487|NCT02013622|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Week 1 to Week 16|All participants who took one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment, the last observation carried forward (LOCF) dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10488|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10489|NCT02013622|Secondary|Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10490|NCT02013622|Primary|Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The observed case (OC) data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10491|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Barratt Impulsiveness Scale 11-Item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10492|NCT02013609|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
10493|NCT02013609|Secondary|Mean Change From Baseline in Food Delay Discounting Task (DDT)|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
10494|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Delay and Probability Discounting Task (DPDT)|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases.The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
10495|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||Number of Impulsive Choices||Standard Deviation|Mean
10496|NCT02013609|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) k Value|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||unitless||Standard Deviation|Mean
10497|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||milliseconds||Standard Deviation|Mean
10498|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (P-inhibition Failure)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||failures||Standard Deviation|Mean
10499|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Kellner Symptom Questionnaire (KSQ) Total Score|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23.The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place. A higher score indicates more distress than a lower score.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10500|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10509|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Total Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
10501|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Social Adaptation Self-evaluation Scale (SASS) Total Score|The SASS was a self-rated instrument to assess the social motivation and behavior in participants with depression. It contained 21 items covering the different aspects of social interactions, global social attitude, and self-perception. The SASS total score will be un-evaluable if less than 16 of the 20 items (for item number 1 and item number 2, participant is to answer either one of these) are recorded. If 16 to 19 of the 20 items are recorded, the SASS total score will be the mean of the recorded items multiplied by 20 and then rounded to the first decimal place.Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range of 0 to 60 (higher scores, indicating worse outcome).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10502|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) Single Item Sub-scores|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10503|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) 3-item Total/Summed Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10504|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.||Units on a scale||Standard Error|Least Squares Mean
10505|NCT02013609|Secondary|Percentage of Participants With MADRS Remission|MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||percentage of participants|||Number
10506|NCT02013609|Secondary|Percentage of Participants With MADRS Response|MADRS response rate was defined as ≥ 50% reduction in respective total scores from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.||percentage of particpants|||Number
10507|NCT02013609|Secondary|Number of Participants With CGI-I Response|The CGI-I response rate was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 1, 2, 3, 4, 6, 8 ,10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit||participants|||Number
10508|NCT02013609|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 12|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Weeks 1, 2, 3, 4, 5, 6, 8, 10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit||Units on a scale||Standard Deviation|Mean
10533|NCT02013388|Primary|Pharmacokinetics: Day 1 AUClast|Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration|Day 1|All patients that had plasma samples collected were included in the analysis||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
10534|NCT02013388|Primary|Safety and Tolerability of N91115|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|21 Days|All patients enrolled in the study were evaluated for safety endpoints||participants|||Number
10510|NCT02013609|Primary|Mean Change From Baseline to Week 12 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). Detailed instructions for administration of this structured interview was provided in the SIGMA. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
10511|NCT02013531|Secondary|Mean Change From Baseline in Barratt Impulsiveness Scale 11-item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. The BIS-11 was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10512|NCT02013531|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10513|NCT02013531|Secondary|Mean Change From Baseline in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10514|NCT02013531|Secondary|Mean Change From Baseline to Week 6 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Number of Impulsive Choices||Standard Deviation|Mean
10515|NCT02013531|Secondary|Mean Change From Baseline in Delay and Probability Discounting Task (DPDT) Scores|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value: value = A / (1 + hO) p is probability of reward and O is odds against. The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10516|NCT02013531|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Score|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||unitless||Standard Deviation|Mean
10517|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for Mean Reaction Time|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||milliseconds||Standard Deviation|Mean
10518|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for P-inhibition Failures|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||failures||Standard Deviation|Mean
10519|NCT02013531|Secondary|Mean Change From Baseline in Kellner Symptom Questionnaire (KSQ)|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23. A higher score indicates more distress than a lower score. The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10520|NCT02013531|Secondary|Mean Change From Baseline in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42, with higher scores indicative of a worse outcome. The MGH-CPFQ was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10521|NCT02013531|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10522|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score|The HAM-A was utilized for the evaluation of anxiety symptoms and was administered using the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). Detailed instructions for administration of this structured interview were provided in the SIGH-A. The HAM-A was administered at the following visits: screening, Baseline, Weeks 1, 2, 3, 4, and 6/ET. HAM-A is a 14-item scale with each item is scored on a scale from 0 (not present) to 4 (very severe) with a total score of 0 to 56, with higher scores indicating severe anxiety symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.||Units on a scale||Standard Error|Least Squares Mean
10603|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
10523|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. The HAM-D17 was administered at the following visits: screening, Baseline, and Week 6/ Early termination (ET). HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10524|NCT02013531|Secondary|Percentage of Participants With a MADRS Remission|MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Percentage of participants|||Number
10525|NCT02013531|Secondary|Percentage of Participants With a MADRS Response|MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Percentage of participants|||Number
10526|NCT02013531|Secondary|Percentage of Participants With CGI-I Response Rate|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Week 1 to Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||percentage of participants|||Number
10527|NCT02013531|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.||Units on a scale||Standard Deviation|Mean
10528|NCT02013531|Secondary|Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.||Units on a scale||Standard Error|Least Squares Mean
10529|NCT02013531|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid Baseline and Post-Baseline efficacy assessment. A mixed model repeated measures (MMRM) analysis was performed.||Units on a scale||Standard Error|Least Squares Mean
10530|NCT02013388|Primary|Pharmacokinetics: Plasma Cmax Values on Day 14|Plasma Cmax values from Day 14 subjects with repeat administration of N91115|Day 14|All subjects completing plasma collection sampling for N91115||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10531|NCT02013388|Primary|Pharmacokinetics: Day 1 Plasma Cmax Values|All subjects who completed sample collections for Day 1 plasma N91115|Day 1|All subjects that completed the plasma collection sampling were included in the analysis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10532|NCT02013388|Primary|Pharmacokinetics: AUCtau Day 14|Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115|Day 14|All patients that completed the required days of dosing to study end||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
10604|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
10535|NCT02013206|Secondary|Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to 2 years|Safety Population included all registered participant who received at least one study treatment and had at least one safety follow-up.||participants|||Number
10536|NCT02013206|Secondary|Overall Survival|Overall survival was defined as the time in months from the start of treatment to the date of death irrespective of the cause of death.|Up to 2 years|Safety Population included all participants with at least one study treatment and had at least one safety follow-up. Patients who had not died at the time of the final analysis were censored at the date of last contact.||months||95% Confidence Interval|Median
10537|NCT02013206|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was defined as the time in months from the start of treatment until the first date criteria for Progressive Disease (PD) were met (taking as reference the smallest measurements recorded since the treatment started), or the date of death for any reason in the absence of PD. Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.|Up to 2 years|Safety Population included all registered participants who received at least one study treatment and had at least one safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.||months||95% Confidence Interval|Median
10538|NCT02013206|Secondary|Time to Progression|Time to progression was defined as the time from start of treatment until the first date criteria for Progressive Disease (PD) was met (taking as reference the smallest measurements recorded since the treatment started). Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Safety Population included all registered patients who received at least 1 dose of study treatment and had at least 1 safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.||months||95% Confidence Interval|Median
10539|NCT02013206|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) until the first date Progressive Disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until the date of death. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Participants from the Intent-to-Treat (ITT) Population, that included all participants, with CR or PR. Patients still responding to treatment at the time of analysis were treated as censored observations for duration of response on the date of the last tumour assessment.||months||95% Confidence Interval|Median
10540|NCT02013206|Secondary|Disease Control Rate|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Up to 2 years|Intent-to-Treat Population included all registered participants.||percentage of participants||95% Confidence Interval|Number
10541|NCT02013206|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST). The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). The patient's best response assignment depended on the achievement of both measurement and confirmation criteria. To be assigned the status of PR or CR, changes in tumour measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met.~CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD."|Up to 2 years|Intent-to-Treat Population included all registered participants.||percentage of participants||95% Confidence Interval|Number
10570|NCT02011113|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||weeks||95% Confidence Interval|Median
20894|NCT01757561|Secondary|the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia||before anesthesia,after extubation,1 day after operation||||||
10542|NCT02013206|Primary|Non-Progression Rate (NPR) at 8 Weeks|Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 8|Intent-to-Treat Population included all registered participants.||percentage of participants||95% Confidence Interval|Number
10543|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|48 hours after thyroidectomy|||scores on a scale||Full Range|Median
10544|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|24 hours after thyroidectomy|||scores on a scale||Inter-Quartile Range|Median
10545|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|6 hours after thyroidectomy|||scores on a scale||Inter-Quartile Range|Median
10546|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|0.5 hours after thyroidectomy|||scores on a scale||Full Range|Median
10547|NCT02012582|Primary|Safety and Tolerability of VAS203 in Patients With Moderate and Severe TBI|"Tolerability (good, satisfactory, sufficient, poor) of VAS203 in patients with moderate and severe TBI, as judged by the investigators at day 14.~Safety outcome measure description see safety section"|14 days|||participants|||Number
10548|NCT02012582|Post-Hoc|Extended Glasgow Outcome Score (eGOS)|"Scoring: Range from 1 (worst outcome) to 8 (good outcome). The patient´s overall rating is based on the lowest outcome category indicated on the scale.~Score Description~Dead~Vegetative State~Lower Severe Disability~Upper Severe Disability~Lower Moderate Disability~Upper Moderate Disability~Lower Good Recovery~Upper Good Recovery"|6 months after start of treatment|||units on a scale||Full Range|Median
10549|NCT02012582|Secondary|Therapy Intensity Level Score|"Therapy Intensity Level Score: Total Score calculated daily as the sum of all individual measures, range from 3 (good outcome) to 50 (worst outcome):~Scores:~0-2 Head elevation 0-8 Sedation 0-1 Paralysis 1-3 Hyperventilation 0-2 Increased Oxygenation 1-3 Cooling 0-2 Osmotherapy 0-3 CSF Drainage 0-1 Red Blood Cell Transfusion 1-3 Cerebral perfusion pressure 0-1 Surgery for mass lesion 0/5/10 none/unilateral/bilateral Decompressive Craniectomy 0/10 Laparatomy to treat intracranial hypertension due to abdominal hypertension"|Daily from day 1 to day 6|||units on a scale||Standard Deviation|Mean
10550|NCT02012582|Secondary|Duration (Number of Hours) of Cerebral Perfusion Pressure (CPP) < 60 mmHg|Duration (number of hours) of cerebral perfusion pressure (CPP) < 60 mmHg calculated from ICP and mean arterial blood pressure (MAP): CPP = MAP - ICP)|Hourly from start of infusion to 144 hours|||hours||Standard Deviation|Mean
10551|NCT02012582|Secondary|Duration (Number of Time-points) of Intracranial Pressure (ICP) > 20 mmHg||Hourly from start of infusion to 144 hours|||hours||Standard Deviation|Mean
10552|NCT02012452|Secondary|Percent Abstinent From Tobacco Use|biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples|end of treatment|If participants did not come the follow-up visit they were assumed to be smokers. If they attended a later follow-up visit, tobacco use was retroactively assessed.||percent abstinent|||Number
10553|NCT02012452|Primary|Clinician Administered PTSD Scale|posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)|end of 6 week PTSD treatment|||units on a scale||Standard Deviation|Mean
10554|NCT02012218|Primary|Mean Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, with 0 being the “best” rating and 6 being the “worst” rating). The MADRS total score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below.|Baseline and Week 6|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid post-baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
10555|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Rate Constant (λz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||1/hr||Geometric Coefficient of Variation|Geometric Mean
10556|NCT02011490|Primary|Geometric Mean Effective Half-life (t1/2eff) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. t½eff was calculated as ln(2)*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Geometric Coefficient of Variation|Geometric Mean
10557|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Half-life (t1/2) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase, calculated as the natural log of 2 (ln[2])/λz.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Geometric Coefficient of Variation|Geometric Mean
10558|NCT02011490|Primary|Median Time of the Last Measurable Plasma Concentration (Tlast) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tlast was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Full Range|Median
10559|NCT02011490|Primary|Median Time to Maximum Observed Plasma Concentration (Tmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tmax was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Full Range|Median
10560|NCT02011490|Primary|Geometric Mean Apparent Volume of Distribution Estimated at Steady-state (Vss) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state, calculated as CL*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||L||Geometric Coefficient of Variation|Geometric Mean
10561|NCT02011490|Primary|Geometric Mean of Mean Residence Time (MRT) of Unchanged Drug in the Systemic Circulation Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||hr||Geometric Coefficient of Variation|Geometric Mean
10562|NCT02011490|Primary|Geometric Mean Volume of Distribution During the Terminal Elimination Phase (Vz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vz was calculated as Dose/(AUC0-∞*λz).|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||L||Geometric Coefficient of Variation|Geometric Mean
10563|NCT02011490|Primary|Geometric Mean Total Clearance (CL) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as Dose/AUC0-∞.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||L/hr||Geometric Coefficient of Variation|Geometric Mean
10571|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||weeks||95% Confidence Interval|Median
10564|NCT02011490|Primary|Geometric Mean Percent of AUC0-∞ That Was Extrapolated (AUC%Extrap) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC%extrap represents the percentage of the AUC0-∞ obtained by extrapolation, calculated as (1 - [AUC0-last/AUC0-∞]) multiplied by 100.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||Percent extrapolated||Geometric Coefficient of Variation|Geometric Mean
10565|NCT02011490|Primary|Geometric Least Squares Mean Maximum Observed Plasma Concentration (Cmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Cmax was determined from the observed plasma concentration-time data. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of Cmax. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||ug/mL||95% Confidence Interval|Least Squares Mean
10566|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-last was determined by trapezoidal method. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of AUC0-last. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||ug*hr/mL||95% Confidence Interval|Least Squares Mean
10567|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Drug Concentration-time Curve From Time Zero to Infinity (AUC0-∞) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-∞ was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC0-last, determined by trapezoidal method) and the extrapolated area given by Cest,last/λz, where Cest,last is the estimated concentration corresponding to the time of the last measurable concentration and λz is the apparent first-order terminal elimination rate constant. For each subject, λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the analysis of variance (ANOVA) linear fixed-effect model performed on natural log-transformed values of AUC0-∞. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.||ug*hr/mL||95% Confidence Interval|Least Squares Mean
10568|NCT02011113|Secondary|Number of Participants With Adverse Events|Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.|From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks|Safety population includes all participants who took at least one dose of study medication.||participants|||Number
10569|NCT02011113|Secondary|Kaplan-Meier Estimates of PFS (Later Cut-off Date)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||weeks||95% Confidence Interval|Median
10572|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks|Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed.|||||
10573|NCT02011113|Secondary|Time to Response (Later Cut-off Date)|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment.||weeks||Full Range|Median
10574|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
10575|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population (EEP) includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
10576|NCT02011113|Secondary|Time to Response|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks.|Included participants with at least a PR or better based on Assessment using IMWG criteria.||weeks||Full Range|Median
10577|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
10578|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.||percentage of participants responding||95% Confidence Interval|Number
10579|NCT02010996|Primary|Early Complications of Vascular Zone||2 weeks|||participants|||Number
10581|NCT02010684|Secondary|Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months|The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
10582|NCT02010684|Secondary|Change From Baseline in EQ-5D at 6 Months|"The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.~The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale."|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
10583|NCT02010684|Secondary|Change From Baseline in Low Density Lipoprotein-C at 6 Months||Baseline and 6 months|||mg/dL||Standard Deviation|Mean
10584|NCT02010684|Secondary|Change From Baseline in Blood Pressure at 6 Months||Baseline and 6 months|||mm Hg||Standard Deviation|Mean
10585|NCT02010684|Primary|Change From Baseline in Depression Measures at 6 Months|"The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.~The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression."|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
10586|NCT02010684|Primary|Change From Baseline in Hemoglobin A1c at 6 Months|Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.|Baseline and 6 months|||percentage of glycated hemoglobin||Standard Deviation|Mean
10587|NCT02010632|Secondary|Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||||
10588|NCT02010632|Secondary|Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||||
10589|NCT02010632|Secondary|Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||||
10590|NCT02010632|Primary|Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)||Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||percent inhibition*hour||Standard Deviation|Mean
10591|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
10592|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
10593|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
10594|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
10595|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
10596|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
10597|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
10598|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
10599|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||Percentage of participants|||Number
10600|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||Percentage of participants|||Number
10601|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||Percentage of participants|||Number
10602|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.||Percentage of participants|||Number
10608|NCT02010255|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttreatment Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.||Percentage of participants|||Number
10609|NCT02010255|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.||Percentage of participants|||Number
10610|NCT02010255|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A and 1 participant in Cohort B who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.||Percentage of participants|||Number
10611|NCT02010255|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.||Percentage of participants|||Number
10612|NCT02010255|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.||Percentage of participants|||Number
10613|NCT02010255|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.||percentage of participants|||Number
10614|NCT02010255|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
10615|NCT02010255|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.||percentage of participants|||Number
10616|NCT02010216|Primary|Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|12 weeks|Safety population included all participants who received study drug.||participants|||Number
10617|NCT02010216|Primary|Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved|American College of Rheumatology (ACR) ACR20, ACR50 or ACR70 response is defined as a ≥ 20% or 50% or 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 12|Intent-to-treat population included all participants.||percentage of participants|||Number
10618|NCT02010216|Primary|Change From Baseline in Disease Activity 28 (DAS28) Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 12|Intent-to-treat population included all participants.||score on a scale||Standard Deviation|Mean
10619|NCT02009982|Secondary|Incidence of Serious Adverse Events|The secondary endpoint for this study will be the incidence of serious adverse events related to the study procedure within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.|||||
10620|NCT02009982|Primary|Syncope Recurrence Rate|The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.|||||
10638|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
10621|NCT02009878|Secondary|Change From Baseline in Cumulative Urine Volume at 0-6 Hours, 0-12 Hours and 0-24 Hours.|Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4, to 6, 6, to 8, 8, to 12, and 12 to 24 hours relative to Day 1 dosing time. Urine was collected on Day 1 at intervals of 0 to 2,2 to 4, 4 to 6, 6 to 8, 8 to 12, and 12 to 24 hours postdose. For the start of the urine collection on Day 0, a window of 15 to 40 minutes prior to the assigned dosing time was acceptable, with the 0 to 24 hour collection period on Day 1 starting 24 hours after the start time on Day 0. Participants were asked to void immediately prior to the end of the collection interval. The volume of individual voids were measured and recorded prior to refrigerating. All voids in a collection interval were pooled at the end of the collection interval, at which time the volume was determined, recorded and an aliquot taken for osmolality, sodium, potassium, and creatinine assessments.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mL||Standard Deviation|Mean
10622|NCT02009878|Secondary|Change From Baseline in Fluid Balance (Fluid Intake Minus Urine Output) From 0-6 Hours, 0-12 Hours and 0-24 Hours.|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12 hours, and 12 to 24 hours relative to the Day 1 dosing time. Fluid balance was determined as fluid intake minus urine output.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mL||Standard Deviation|Mean
10623|NCT02009878|Secondary|Change From Baseline in Fluid Intake From 0-6 Hours, 0-12 Hours and 0-24 Hours|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mL||Standard Deviation|Mean
10624|NCT02009878|Primary|Time of Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Time of maximal increase in serum sodium is summarized in the table below by tolvaptan dose. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||hours||Full Range|Median
10625|NCT02009878|Secondary|Change From Baseline in Serum Sodium Concentrations|Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mmol/L||Standard Deviation|Mean
10626|NCT02009878|Secondary|AUC Infinity (Area Under the Concentration-time Curve From Time Zero to Infinity) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. If an indwelling catheter was utilized, saline flushes were used. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.||ng·h/mL||Standard Deviation|Mean
10627|NCT02009878|Secondary|Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.||hours||Full Range|Median
10628|NCT02009878|Secondary|Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.||ng/mL||Standard Deviation|Mean
10629|NCT02009878|Primary|Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Maximal increase in serum sodium is summarized below by tolvaptan dose. Blood samples for determination of plasma concentrations of tolvaptan were collected predose and at 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose on Day 1 or at Early Termination (ET).|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.||mmol/L||Standard Deviation|Mean
10630|NCT02009865|Secondary|Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6)|This secondary endpoint in subjects with Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6), together with the 2nd. and 3rd.secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
10631|NCT02009865|Secondary|Percent Change in High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 2nd. and 4th. secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
10632|NCT02009865|Secondary|Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 3rd. and 4th secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS||Percentage of change (%)||Inter-Quartile Range|Median
10639|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
10640|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
10641|NCT02009722|Secondary|Side Effects: Sedation|Patients will be evaluated by a member of the study team at 6, 12, and 24 hours after spinal administration. The presence of sedation will be graded by the Richmond Agitation Sedation Scale. Patients with a score of (-)2 or lower on the Richmond were classified as being positive for sedation.|6, 12, and 24 hours after spinal administration|||participants|||Number
10642|NCT02009722|Secondary|Side Effects: Nausea|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. Patients with moderate or severe nausea will be recorded.|6 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
10643|NCT02009722|Secondary|Side Effects: Pruritus|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|6 hours after spinal administration|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis||participants|||Number
10644|NCT02009722|Primary|Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients|Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score <4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients|12 hours after administration of spinal anesthesia|The primary outcome was determining the optimal dose of IT morphine and IT hydromorphone for patients undergoing cesarean delivery. Study was designed to determine the ED90 (effective dose in 90% patients; effective dose meaning a VAS score for pain of 3 or less at 12 hours after spinal placement).||micrograms|||Number
10645|NCT02009696|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
10646|NCT02009696|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
10647|NCT02009696|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
10648|NCT02009696|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
10649|NCT02009696|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
10650|NCT02009163|Secondary|Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up|The ACSA was used in this study to assess potential withdrawal symptoms associated with chronic use of SPD489. The ACSA is a self-completed scale used to assess withdrawal symptoms. The scale has 16 symptom items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The ACSA total score ranges from 0-64, where a higher score indicates greater withdrawal symptom severity.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose)|The RSAS. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Visits 21 and 22 could include participants who discontinued but completed a final safety and efficacy assessment. Not all participants had data for this outcome.||units on a scale||Standard Deviation|Mean
10651|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Randomized Safety Analysis Set (RSAS), defined as participants in the SAS who were randomized and took at least 1 dose of investigational product in the randomized-withdrawal period. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Three participants had no data for this outcome.||participants|||Number
10652|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 8 (12 weeks after start of open-label treatment [Week 12])|The OSP. Three participants in the OSP did not have data collected for this outcome. Visit 8 included only participants who completed open-label treatment.||participants|||Number
10653|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
10654|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
10655|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
10656|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
10657|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
10676|NCT02007577|Primary|Quantification of Insulin Action With the Insulin Suppression Test (IST)|Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group|after treatment for one month|||mmol/L||95% Confidence Interval|Median
10677|NCT02007434|Secondary|Patient Experience Questions|"Participants were asked to complete 3 patient experience questions, each answered as Yes or No:~Given your experience in this study:~Would you recommend this procedure to a friend?~Would you agree to receive additional treatments?~Has the treatment you received in this study affected your normal activities?~The percentage of participants answering Yes on each question is reported."|Day 84|Safety analysis set with available data at each time point||percentage of participants|||Number
10658|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
10659|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
10660|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
10661|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5­-Dimension 5­-Level Self­-Report Questionnaire (EQ­-5D­-5L) For Mobility at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
10662|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.||percentage of participants|||Number
10663|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period|The Y-BOCS-BE measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. The scale is a clinician rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The scale includes questions regarding the amount of time spent on obsessions, impairment or distress experienced, and resistance and control over these thoughts. The same types of questions were asked about compulsions (ie, time spent, interference, etc.).Total scores range from 0 to 40. A total score of 0-7 is sub-clinical, 8-15 is mild, 16-23 is moderate, 24-31 is severe, and 32-40 is extreme. A decrease from baseline in Y-BOCS-BE Total Score represents an improvement in obsession with binge-eating thoughts or compulsiveness of binge-eating behaviors.|Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=54; SPD489: n=107).||units on a scale||Standard Error|Least Squares Mean
10664|NCT02009163|Secondary|Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period|The CGI-S permits a global evaluation of a subject’s condition and severity of symptoms. The CGI-S was performed to rate the severity of a subject’s condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||percentage of participants|||Number
10665|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Number of Binge­ Eating Days Per Week During The Randomized-withdrawal Period|A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomized ­withdrawal-baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8).|Randomized­-withdrawal baseline (Visit 8; 12 weeks after start of open­ label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=50; SPD489: n=102).||days||Standard Error|Least Squares Mean
10666|NCT02009163|Primary|Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period|Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse – date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject’s condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Full Analysis Set (FAS): participants in the Randomized Safety Analysis Set (RSAS) with at least 1 post-randomization CGI-S assessment. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.||days||Inter-Quartile Range|Median
10667|NCT02008942|Primary|Time to 99% Inhibition of Serum Thromboxane|Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|11 days|Pharmacodynamic (PD) Evaluable Population - patients in the intent-to-treat population who received a full treatment regimen for each of 2 study drugs, had all scheduled PD blood draws, and had no other major protocol violations.||hours||Standard Deviation|Mean
10668|NCT02008682|Secondary|Number of Confirmed Hypoglycaemic Episodes|confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L|Weeks 0-26|Safety analysis set included all subjects receiving at least one dose of investigational product.||episodes|||Number
10669|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||percentage of subjects|||Number
10670|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||percentage of subjects|||Number
10671|NCT02008682|Secondary|Change From Baseline in 7-point Self-measured Plasma Glucose Profile|Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||mmol/L||Standard Deviation|Mean
10672|NCT02008682|Secondary|Change From Baseline in Fasting Plasma Glucose|Mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||mmol/L||Standard Deviation|Mean
10673|NCT02008682|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
10674|NCT02007863|Primary|Number of Successful Unrelated Cord Blood (UCB) Transplants|The number of patients who received successful UCB transplants as evidenced by absolute neutrophil recovery.|2 Years|THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.Unrelated Cord Blood (UCB) transplant||participants|||Number
10675|NCT02007577|Secondary|Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT)|compare changes in insulin clearance as assessed by the GGIT before and after treatment with salsalate to placebo|one month on treatment|||pmol/min x 4h||95% Confidence Interval|Median
10679|NCT02007434|Secondary|Change From Baseline in Submental Skin Laxity Grades (SMSLG)|Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
10680|NCT02007434|Secondary|Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
10681|NCT02007434|Secondary|Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
10682|NCT02007434|Secondary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at each time point.||units on a scale||Standard Deviation|Mean
10683|NCT02007434|Primary|Induration Grading Scale Scores|"The following grading system was used for the assessment of induration:~Induration absent to minimal (0)~Induration associated with at least approximately 30% of the treatment area (1)~Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)~Induration covering the entire treatment area but contained within the treatment area (3)~Induration of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data||units on a scale||Standard Deviation|Mean
10684|NCT02007434|Primary|Bruising Grading Scale Scores|"The following grading system was used for the assessment of bruising:~Bruising absent (0)~Bruising associated with 1 to 3 needle insertion points (1)~Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)~Bruising covering the entire treatment area but contained within the treatment area (3)~Bruising of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data||units on a scale||Standard Deviation|Mean
10685|NCT02007434|Primary|Swelling Grading Scale Scores|"The following grading system was used for the assessment of swelling:~Swelling/edema absent (0)~Minimal swelling/edema contained within treatment area (1)~Modest swelling/edema contained within treatment area (2)~Substantial swelling/edema contained within treatment area (3)~Swelling/edema of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data||units on a scale||Standard Deviation|Mean
10686|NCT02007434|Primary|Change From Baseline in Pain Assessment Using McGill Pain Questionnaire|Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).|Baseline (predose) and Day 84|Safety analysis set with available data at both time points||units on a scale||Standard Deviation|Mean
10687|NCT02007434|Primary|Change From Baseline in Pain Visual Analog Scale Scores|Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).|Baseline and Day 84|Safety analysis set with available data at both time points||units on a scale||Full Range|Median
10688|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 6 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 6 months.|6 months|||participants|||Number
10689|NCT02007369|Primary|Self Reported Relapse Rate at 6 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 6 months.|6-months|||participants|||Number
10690|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 2 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 2 months.|2 months|||participants|||Number
10691|NCT02007369|Primary|Self Reported Relapse Rate at 2 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 2 months.|2 months after joining the groups for the social networking services.|||participants|||Number
10692|NCT02007252|Primary|Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year|Size of the AAA was determined using an abdominal ultrasound technique at baseline, 3 months, and 12 months after treatment with study drug. Growth rate (in mm/year) was calculated from the change in AAA size compared to baseline|month 3, month 12|The pharmacodynamic analysis set, which included randomized participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at each time point were analyzed.||millimeter/year||90% Confidence Interval|Least Squares Mean
12666|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
10693|NCT02007200|Secondary|The Number of Participants Alive Without Relapse at Last Follow-up|Relapse-free survival will be determined at the last follow-up visit.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.||participants|||Number
10694|NCT02007200|Secondary|The Number of Participants Alive at Follow-up|Overall survival at last follow-up will be determined.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.||participants|||Number
10695|NCT02007200|Primary|Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF|Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.|Up to 12 months|We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.|||||
10696|NCT02007200|Primary|Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone|The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.|From baseline to surgery, up to 42 days|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.||Percent change||Full Range|Mean
10697|NCT02007070|Secondary|Overall Survival (OS)|OS is defined as the time from the first day of study treatment to death due to any cause. OS is reported in months.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
10698|NCT02007070|Secondary|Duration of Response (DOR) by RECIST 1.1|DOR is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in weeks.|Up to 2 years|The analysis population consisted of the FAS population (all participants who received at least one dose of study drug and had Baseline data for the analyses that require Baseline data) with confirmed responders.||Weeks||Full Range|Median
10699|NCT02007070|Secondary|Progression Free Survival (PFS) by RECIST 1.1|PFS is defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists’ review or death due to any cause, whichever occurs first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
10700|NCT02007070|Primary|Number of Participants Discontinuing Study Drug Due to AEs|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.||Participants|||Number
10701|NCT02007070|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days for AE monitoring (serious AEs were monitored for up to 90 days after last dose of study drug).|Up to 2 years|The All Treated Set (ATS) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
10702|NCT02007070|Primary|Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR is defined as the proportion of participants in the analysis population who have a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters).|Up to 2 years|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had Baseline data for the analyses that require Baseline data.||Percentage of Participants||95% Confidence Interval|Number
10813|NCT02004236|Secondary|Theta Amplitude in T5 After tRNS|Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
10703|NCT02006836|Primary|AUCs With/Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. Capillary blood samples were detected before and after meals, 10pm, and 3am. Mean of each time point(before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner,10pm, and 3am ) of blood glucose concentrations on 4th to 6th day（without pomelo） were calculated and so as each time point of blood glucose concentrations on 7th to 9th day (with pomelo). Areas under the curves (AUC) of mean blood glucose concentrations of each time point were obtained with/without pomelo.|9 days|||mmol*hour/L||Standard Deviation|Mean
10704|NCT02006836|Primary|∆g of Dinner With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after dinner were obtained and analyzed.~g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner without pomelo - mean of 3 days of blood glucose before this dinner.~g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner with pomelo - mean of 3 days of blood glucose before this dinner."|9 days|||mmol/l||Standard Deviation|Mean
10705|NCT02006836|Primary|∆g of Lunch With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after lunch were obtained and analyzed.~g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch without pomelo - mean of 3 days of blood glucose before this lunch.~g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch with pomelo- mean of 3 days of blood glucose before this lunch."|9 days|||mmol/l||Standard Deviation|Mean
10706|NCT02006836|Primary|∆g of Breakfast With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after breakfast were obtained and analyzed.~g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."|9 days|The patients met the inclusion/exclusion criteria and completed the study.||mmol/l||Standard Deviation|Mean
10707|NCT02006836|Primary|Glycemic Index|"Glycemic index (GI) measurement was carried out after an overnight fast on 2 occasions in every subject, each test being separated from the next by a “washout” day.The first test day utilized 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of the Majia pomelos. Venous blood samples were collected and monitored during 3 hrs for both the healthy and T2DM individuals at 0, 30, 60, 90, 120, 150, and 180 min. Areas under the curves (AUC) of blood glucose concentrations were obtained. The 50 g of glucose was used as the reference (GI = 100) according to the literature. The AUC under the incremental glycemic-response curves for Majia were expressed as a percentage of the areas under the glucose curves for the same subject. The resulting values for all subjects were averaged to calculate the GI.~GI measurement is only calculated in case-control period."|3 days|||percentage of AUC from GI100||Standard Deviation|Mean
10708|NCT02006732|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
10709|NCT02006732|Secondary|TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS after combining the data from this and the replicate study NCT01964352||Units on a scale||Standard Error|Mean
10710|NCT02006732|Secondary|TDI Focal Score Based on Data From This Individual Study|"Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS||Units on a scale||Standard Error|Mean
10711|NCT02006732|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
10827|NCT02004093|Secondary|Kaplan-Meier Probability of Being Progression Free at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 16 and 10 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.||percent|||Number
10712|NCT02006732|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS after combining the data from this and the replicate study NCT01964352||units on a scale||Standard Error|Mean
10713|NCT02006732|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study|"The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS||units on a scale||Standard Error|Mean
10714|NCT02006732|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
10715|NCT02006732|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints.||L||Standard Error|Mean
10716|NCT02006706|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 24|PP Population||score on a scale||Standard Deviation|Mean
10717|NCT02006706|Primary|Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24|DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 24|Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.||score on a scale||Standard Deviation|Mean
10718|NCT02006667|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS||percentage of participants|||Number
10719|NCT02006667|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Screening, and Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
10720|NCT02006667|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to OS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS||months||95% Confidence Interval|Median
10721|NCT02006667|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS||percentage of participants|||Number
10722|NCT02006667|Primary|Percentage of Participants Who Were Progression Free at 12 and 24 Months||Screening, and Months 12 and 24|FAS||percentage of participants||95% Confidence Interval|Number
10723|NCT02006667|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first dose of study treatment to PFS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS||months||95% Confidence Interval|Median
10724|NCT02006667|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS||percentage of participants|||Number
10725|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months|Determine the change in cognitive test scores from baseline, at 6 months using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints (Baseline and 6 months) using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis based upon results in adults treated with radiation therapy is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will correlate with changes in global response as measured on COGState with the sub-domains on executive function most highly correlated. In addition, these regional changes in DTI will be directly related to the radiation doses received in these regions.|6 months|Data can not be accessed due to technical difficulties with the COGState server.|||||
10726|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment.|Determine the change in cognitive test scores from baseline to time-points early during radiation therapy (3 and 6 weeks) using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will be measurable even in this acute setting and will correlate with global response as measured on COGState with the sub-domains on executive function anticipated to be most highly correlated.|Baseline, 3 weeks, and 6 weeks|Data can not be accessed due to technical difficulties with the COGState server.|||||
10727|NCT02006407|Primary|Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy.|Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.|Baseline, 3 weeks, and 6 weeks|Because the outcome measure was CHANGE FROM BASELINE to 3 and 6 weeks, and data were not able to be collected at 3 and 6 weeks, the outcome measure could not be analyzed|||||
10728|NCT02005692|Primary|Turn Protocol Compliance|The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.|Subjects will be followed for the length of hospital stay which is expected to average 5 days.|||percentage turn compliance||95% Confidence Interval|Number
10729|NCT02005692|Primary|Safety Primary Endpoint|The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.|Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.|||percentage of subjects with ADEs|||Number
10730|NCT02005562|Secondary|Participant Survival|Participants survival was defined as the percentage of participants living with or without a functioning graft between Weeks 0 and 52. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||percentage of participants|||Number
10731|NCT02005562|Secondary|Time to Graft Loss|The median time, in days, from randomization to graft loss event. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||days||Full Range|Median
10732|NCT02005562|Secondary|Graft Loss - Percentage of Participants With an Event|Graft loss was defined as physical loss (nephrectomy), functional loss [necessitating maintenance dialysis for greater than (>)8 weeks], retransplant or death. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||percentage of participants|||Number
10733|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population||percentage of participants|||Number
10734|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population||percentage of participants|||Number
10735|NCT02005562|Secondary|Percentage of Participants With at Least One BPAR at Week 12 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population; only participants with at least one assessed biopsy were included in the analysis.||percentage of participants|||Number
10736|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||days||95% Confidence Interval|Median
10749|NCT02005536|Primary|Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®|A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 28 post-vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.||Percentage of participants|||Number
10855|NCT02002871|Other Pre-specified|Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)|Higher values describe a higher level of pigmentation.|week 6|||arbitrary units||Standard Deviation|Mean
10737|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population||percentage of participants|||Number
10738|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the MDRD simplified equation. For males, the MDRD simplified equation was defined as MDRD (mL/min/1.73 square meters [m^2]) =186 multiplied by (*) serum creatinine in mg/L raised to the power of (^) -1.154 * age ^ -0.203. For females, the MDRD simplified equation was defined as MDRD (mL/min/1.73 m^2) = males formula * 0.742.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Deviation|Mean
10739|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the Cockcroft-Gault equation.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
10740|NCT02005562|Secondary|Serum Creatinine Values [Micromoles Per Liter (µmol/L)]|The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; number (n) = number of participants assessed for the specified parameter at a given visit.||µmol/L||Standard Deviation|Mean
10741|NCT02005562|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.|Week 12|ITT population; only participants with available protocol biopsy at Week 12 and/or a BPAR before Week 12 were included in the analysis.||percentage of participants|||Number
10742|NCT02005549|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)|20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population.||percentage of participants||95% Confidence Interval|Number
10743|NCT02005549|Secondary|Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)|Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.||percentage of participants||95% Confidence Interval|Number
10744|NCT02005549|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.||percentage of participants||95% Confidence Interval|Number
10745|NCT02005536|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received study vaccine (Safety Analysis Set).||Number of participants|||Number
10746|NCT02005536|Secondary|Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®|Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.|Day 28 post-booster vaccination|Geometric mean of individual titer ratios were assessed in the per-protocol analysis set.||Titer Ratio||95% Confidence Interval|Geometric Mean
10747|NCT02005536|Secondary|Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®|Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.||Percentage of participants|||Number
10748|NCT02005536|Secondary|Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®|Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Geometric mean titers was assessed in the per-protocol analysis set.||Titers||95% Confidence Interval|Geometric Mean
10750|NCT02005484|Secondary|Time to Progression|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||months||Full Range|Median
10751|NCT02005484|Secondary|Time to Progression - Number of Participants With an Event|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||participants|||Number
10752|NCT02005484|Secondary|Overall Survival|Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||months||Full Range|Median
10753|NCT02005484|Secondary|Overall Survival - Number of Participants Who Died|OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population||participants|||Number
10754|NCT02005484|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.|Weekly throughout the study|ITT population||percentage participants|||Number
10755|NCT02005484|Secondary|Percentage of Participants With Clinical Benefit|Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD. Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable SD: not qualifying for CR, PR, or PD.|Weekly throughout the study|ITT population||percentage participants|||Number
10756|NCT02005484|Primary|Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category|Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).|Weekly throughout study|ITT population||percentage of participants|||Number
10757|NCT02005211|Primary|Safety - Adverse Events|Safety - Number of subjects reporting any adverse events during the study|Day of first dose to follow up|Safety||Participants|||Number
10758|NCT02005211|Secondary|Biomarker|Biomarker (Abeta 1-40; A beta 1-42) % change from baseline|Pre dose vs Day 14|Pharmacodynamic||% change from baseline||Standard Deviation|Mean
10759|NCT02005211|Secondary|PK AUC - Overall Study (SAD & MAD Parts)|Pharmacokintic Area Under the Curve (0 to t)|0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|healthy Japanese participants||hr.ng/mL||Geometric Coefficient of Variation|Geometric Mean
10760|NCT02005211|Secondary|PK Cmax - Overall Study|Pharmacokinetic maximum concentration|0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|Pharmacokinetic||ng/mL||Geometric Coefficient of Variation|Geometric Mean
10761|NCT02005029|Secondary|Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo|Mean Cmax of plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels throughout the study and was thus excluded from the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
10762|NCT02005029|Secondary|MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)|Part 3 of this scale is a standardized physical assessment that quantifies the total burden of motor symptoms in Parkinson's disease patients. Each of the 18 items on the scale is rated from 0 (none, 1 (slight), 2 (mild), 3 (moderate) and 4 (severe). Scores range from 0-72. Higher scores represent a more severe burden of motor symptoms (a worse outcome).|2 weeks, between visits 2 and 3|One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||units on a scale||Standard Deviation|Mean
10763|NCT02005029|Secondary|Change in Dyskinesia|Mean total AIMS (Abnormal Involuntary Movements Scale) score after receiving erythromycin minus mean total AIMS score after receiving placebo. The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. Ten of the items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the items are not scored. Total score range is from 0 to 40. Higher scores represent more severe dyskinesia (a worse outcome).|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||units on a scale||Standard Deviation|Mean
10764|NCT02005029|Secondary|Timed up and go Test (TUAG) Fast Speed|Change in motor function as assessed by timed up and go test (fast speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
10765|NCT02005029|Secondary|Timed up and go Test (TUAG) Comfortable Speed|Change in motor function as assessed by timed up and go test (comfortable speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
10766|NCT02005029|Secondary|Comfortable 20 Feet Gait Speed (CGS)|Change in motor function as assessed by comfortable 20 feet gait speed (CGS)|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
10767|NCT02005029|Secondary|Five Times Sit-to-stand Test|Change in motor function as measured by Five times sit-to-stand test. This test measures the total time to complete 5 repetitions of sit to stand.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
10768|NCT02005029|Secondary|9-hole Peg Test Left Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
10769|NCT02005029|Secondary|9-hole Peg Test Right Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.||seconds||Standard Deviation|Mean
10770|NCT02005029|Primary|Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo|Mean Area under the Curve 0-4 hours for plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels through out the study and was thus excluded from the pharmacokinetic analysis.||ng/mL*min||Standard Deviation|Mean
10771|NCT02005029|Primary|Gastric Emptying Time|Mean gastric emptying time in minutes as measured by SmartPill|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and four participants were unable to complete a SmartPill evaluation.||minutes||Standard Deviation|Mean
10772|NCT02004990|Secondary|Dental Plaque Composition Measured by Numbers of Bacteria Present|Dental plaque is a multispecies bacterial biofilm and the specific bacteria populating this biofilm will be measured.|2-4 weeks|||micrometers||Standard Deviation|Mean
10773|NCT02004990|Primary|Dental Plaque Levels Measures on Scale of 0-2|Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)|2-4 weeks|||units on a scale||Standard Deviation|Mean
10774|NCT02004886|Secondary|Change From Baseline in 3-hour Insulin Total AUC at Week 4|Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||µIU hr/mL||95% Confidence Interval|Least Squares Mean
10775|NCT02004886|Secondary|Change From Baseline in 3-hour AUC for C-peptide at Week 4|Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||ng hr/mL||95% Confidence Interval|Least Squares Mean
10776|NCT02004886|Secondary|Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4|Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg hr/dL||95% Confidence Interval|Least Squares Mean
10777|NCT02004886|Secondary|Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4|2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
10778|NCT02004886|Secondary|Change From Baseline in Fasting Insulin at Week 4|Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||μIU/mL||95% Confidence Interval|Least Squares Mean
10779|NCT02004886|Secondary|Change From Baseline in Fasting C-peptide at Week 4|Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||ng/mL||95% Confidence Interval|Least Squares Mean
10780|NCT02004886|Secondary|Change From Baseline in Fructosamine at Week 4|Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
10781|NCT02004886|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
10782|NCT02004886|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 28 days|Safety Population included all randomized participants who initiated study therapy.||Number of Participants|||Number
10783|NCT02004886|Primary|Number of Participants Experiencing an Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 42 days|Safety Population included all randomized participants who initiated study therapy.||Number of Participants|||Number
10784|NCT02004886|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.||mg/dL||95% Confidence Interval|Least Squares Mean
10785|NCT02004873|Secondary|Rate Response Operation of Micra|Assessment of whether the Micra sensor-indicated rate derived from the input of the accelerometer during the Minnesota Pacemaker Response Exercise Protocol (M-PREP) treadmill test conducted at the 3-month and 6-month follow-up visits was proportional to the workload. The sensor-indicated rate (in min^-1) and workload (in METS) were normalized for each subject relative to their minimum and maximum possible values so the normalized values have a minimum possible value of zero and a maximum possible value of 1. These normalized values were used in a random effect linear regression model to assess the relationship between the sensor-indicated rate and workload via estimation of the Kay-Wilkoff slope parameter. The tests at 3-month and 6-month visits were combined in one analysis.|3 Months and 6 Months Post Implant (combined analysis)|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.||regression slope parameter|M-PREP tests|90% Confidence Interval|Mean
10786|NCT02004873|Secondary|Ventricular Capture Management Threshold|Subjects that have a ventricular capture management threshold (VCMT) that is within 0.5 Volts of the manual (auto decrement) PCT (at 0.24 ms pulse width) at the 6-month post-implant visit. The VCMT is an automatically measured pacing capture threshold that is measured by the Micra device’s pacing algorithm. In contrast, the manual (auto decrement) pacing capture threshold is measured by the clinician during a study visit.|6 Months Post Implant|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.||participants|||Number
10787|NCT02004873|Primary|Pacing Capture Threshold|Subjects that have an adequate pacing capture threshold (PCT) at the 6-month post-implant visit, which is defined as PCT <=2 volts at 0.24 ms pulse width and the increase in PCT from implant to 6 months <=1.5 volts. The pacing capture threshold is the minimal electrical stimulus required to produce consistent cardiac depolarization. It is the minimum amount of energy that is required for a pacemaker to pace the heart.|6 Months Post Implant|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (at 0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.||participants|||Number
10788|NCT02004873|Primary|Major Complications|Micra system and/or procedure related major complication free rate at 6-months post-implant.|Implant to 6 Months Post Implant|All subjects who attempted Micra implant procedure||Kaplan-Meier survival probability (%)||98.66% Confidence Interval|Number
10789|NCT02004847|Other Pre-specified|Patient Acceptance of Hyperpigmentation|Questionaire|week 16|Safety set (SAF)||percentage of participants|||Number
10790|NCT02004847|Other Pre-specified|Thermal Comfort|Questionaire|week 12|Full Analysis Set||percentage of participants|||Number
10804|NCT02004847|Primary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 12|Full Analysis set (FAS)||units on a scale||Standard Deviation|Mean
10791|NCT02004847|Secondary|Adverse Device Events (Serious and Non-serious)|"Adverse device events: Adverse event related to the use of an investigational medical device wich led to any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons.~Serious adverse device event: Adverse device effect that has resulted in a) led to death, b) led to serious deterioration in the health of the subject, that either resulted in 1) a life-threatening illness or injury, or 2) a permanent impairment of a body structure or a body function, or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) led to foetal distress, foetal death or a congenital abnormality or birth defect."|week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)||number of participants|||Number
10792|NCT02004847|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)||number of participants|||Number
10793|NCT02004847|Other Pre-specified|"Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter"|Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels.|week 4, 12, 16|Safety Set (SAF)||arbitrary units||Standard Deviation|Mean
10794|NCT02004847|Secondary|Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||week 16|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D||days||Standard Deviation|Mean
10795|NCT02004847|Secondary|Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||patients will be followed for the complete duration of the clinical study for 16 weeks|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D||days||Standard Deviation|Mean
10796|NCT02004847|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|It is a simple 10-question validated questionnaire. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. As the change from baseline is calculated negative values in the Outcome Measure Data indicate an improvement in quality of life.|baseline and week 12|Full Analysis Set (FAS)||units on a scale||Standard Deviation|Mean
10797|NCT02004847|Secondary|System Usability Scale|At the end of treatment (visit 7), the usability of the investigational device was evaluated by a questionnaire presented to the patient in German. The usability was evaluated by using the System Usability Scale (SUS) which is an effective tool for assessing the usability of a device. It provides an easy-to-understand score from 0 (negative) to 100 (positive).|week 12|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 for HI group. Only 17 of 22 patients completed the questionaire in the LI group.||units on a scale||Standard Deviation|Mean
10798|NCT02004847|Secondary|Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|week 12 and week 16|Full Analysis Set (FAS); due to one drop out in each group this number is 23 for HI Group and 22 for LI group at week 12 and 16||arbitrary units||Standard Deviation|Mean
10799|NCT02004847|Secondary|Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|baseline and week 4, 12|Full Analysis Set (FAS)||arbitrary units||Standard Deviation|Mean
10800|NCT02004847|Secondary|Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0. = no sign~= slight~= moderate~= marked~= very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12)."|baseline and week 4, 8, 16|Full Analysis Set (FAS)||units on a scale||Standard Deviation|Mean
10801|NCT02004847|Secondary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4, 12, 16|Full Analysis Set (FAS)||units on a scale||Standard Deviation|Mean
10802|NCT02004847|Secondary|Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|Week 12 and week 16|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16||units on a scale||Standard Deviation|Mean
10803|NCT02004847|Secondary|Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4|Full Analysis Set||units on a scale||Standard Deviation|Mean
10805|NCT02004236|Secondary|P3b Wave Amplitude After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
10814|NCT02004236|Secondary|Ratio Theta/Beta After tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions|||Ratio theta/beta after tRNS||Standard Deviation|Mean
10815|NCT02004236|Secondary|Theta Amplitude in T5 Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions|||MicroVolts||Standard Deviation|Mean
10816|NCT02004236|Secondary|Ratio Theta/Beta Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions|||Ratio theta/beta before tRNS||Standard Deviation|Mean
10817|NCT02004236|Primary|Sociability|"Goal: Evaluate emphaty with CARS scale in autism spectrum disorder children between 5 and 12 years after tRNS sessions.~CARS (Childhood Autism Rating Scale) by Shopler & Reichler (1971) in Spanish version EVAI (Escala de Valoración de Autismo Infantil) by Leal-Soto, F.; Aguirre, L.P. y Williams, E.E.~Description: 15 items in the scale that evaluate: Relating to people, Imitative Behavior, Emotional Response, Body Use, Object Use, Adaptation to Change, Visual Response, Listening Response, Perceptive Response, Fear or Anxiety, Verbal Communication, Non-Verbal Communication, Activity level, Level and consistency of Intellective Relations and General Impressions.~Values: The CARS scores range from 15 to 60, with lower scores indicating better outcome. It classifies the child as not autistic (below 30), moderately autistic (30-36.5) or severely autistic (above 36.5)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.||units on a scale||Standard Deviation|Mean
10818|NCT02004236|Primary|Verbal Fluency|"Goal: Improve in verbal fluency in ASD children between 5 and 12 years. We use D-KEFS (Delis-Kaplan Executive Function System Delis Kaplan Sorting Test), Verbal Fluency Subtest - Category Condition.~Description: The verbal fluency Category test evaluates fluent productivity in the verbal domain by asking participants to generate exemplars belonging to the category animals, and subsequently, boys´ names. Participants were given 60 s to do it.~Values: Category scores were based on the average number of items generated in the two categories (animals and boys´names) during 60 s.~Time Frame: Baseline (Before treatment) and 1 day Post-treatment (after completing 3 months of intensive speech therapy during tRNS sessions)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.||units on a scale||Standard Deviation|Mean
10819|NCT02004132|Secondary|Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts|"This is a summary of the amounts of testosterone measured on unworn textile items washed with t-shirt halves exposed to testosterone in a standard washing machine. Total amounts of testosterone on each laundered item other than the t-shirt halves was calculated based on the weight of the fabric sample analyzed and the total weight of the item, assuming a uniform distribution of testosterone across each item as:~(weight of laundered item / weight of laundered sample) x amount of testosterone on laundered sample."|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.||µg||Standard Deviation|Mean
10820|NCT02004132|Secondary|Amount of Testosterone Following Laundering|This is a summary of the amounts of testosterone measured on a 10 cm × 10 cm of material excised from the underarm area of washed t-shirt halves following laundering in a standard washing machine.|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.||µg||Standard Deviation|Mean
10821|NCT02004132|Primary|Amount of Testosterone on T-shirts|This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.|12 hours after application of study drug|Full analysis set (FAS). Data from all enrolled participants completing the study.||micrograms (µg)||Standard Deviation|Mean
10822|NCT02004093|Secondary|Kaplan-Meier Probability of Being Alive at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||percent|||Number
10823|NCT02004093|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis||months||Full Range|Median
10824|NCT02004093|Secondary|Percentage of Participants Who Died||Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis||percentage of participants|||Number
10825|NCT02004093|Secondary|Time To Response|Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|Only participants with a response were included in the analysis.||weeks||Inter-Quartile Range|Median
10826|NCT02004093|Primary|Kaplan-Meier Probability of No Disease or Progression at 1 Year|The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.|1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.||percent|||Number
10856|NCT02002871|Other Pre-specified|Device Deficiencies|This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.|over 6 weeks|||participants|||Number
10828|NCT02004093|Secondary|Time to Progressive Disease|The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated patients with an event (disease progression) were included in analysis||weeks||Inter-Quartile Range|Median
10829|NCT02004093|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated participants were included in analysis||percentage of participants|||Number
10830|NCT02004093|Secondary|Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 7 and 5 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.||percent|||Number
10831|NCT02004093|Secondary|Duration of Response|For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.|Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks|Only participants with a response were included in the analysis; 8 participants and 13 participants were censored in the chemotherapy + pertuzumab and chemotherapy only treatment groups, respectively.||weeks||Inter-Quartile Range|Median
10832|NCT02004093|Secondary|Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements|Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were “response”, “stable disease” and “progressive disease”. Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of “response” or “progressive disease”.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||percentage of participants|||Number
10833|NCT02004093|Primary|Progression-Free Survival|Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||weeks||Full Range|Median
10834|NCT02004093|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated participants who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.||percentage of participants|||Number
10835|NCT02003638|Primary|Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT||12 weeks|||Target to Background Ratio (TBR)||Standard Deviation|Mean
10836|NCT02003534|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Month 3|Intent-to-Treat: patients with baseline data and data at the indicated time point||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
10837|NCT02003404|Primary|Skin Barrier Peel Force|Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.|4 hours|||grams||Standard Deviation|Mean
10838|NCT02003391|Secondary|Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4||Percent Change||Standard Deviation|Mean
10839|NCT02003391|Secondary|Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4||mmHg||Standard Deviation|Mean
10857|NCT02002871|Other Pre-specified|Adverse Device Events (Serious and Non-serious)||over 6 weeks|||participants|||Number
10858|NCT02002871|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 2, 4, 6|||participants|||Number
10859|NCT02002871|Other Pre-specified|Hyperpigmentation – Evaluation by Mexameter|Higher values describe a higher level of pigmentation.|week 0, 2, 4, 6|||arbitrary units||Standard Deviation|Mean
10840|NCT02003391|Primary|Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Week 4|Intent to treat with a measurement in the study eye at Week 4||mmHg||95% Confidence Interval|Least Squares Mean
10841|NCT02003014|Secondary|Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||HOMA-IR score||Standard Deviation|Mean
10842|NCT02003014|Secondary|Change From Baseline in Immunoreactive Insulin (IRI)|The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free [unbound] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||micro units per milliliter (mcU/mL)||Standard Deviation|Mean
10843|NCT02003014|Secondary|Change From Baseline in Body Weight|Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12).|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||kg||Standard Deviation|Mean
10844|NCT02003014|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
10845|NCT02003014|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
10846|NCT02003014|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
10847|NCT02003014|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
10848|NCT02002936|Secondary|Changes in Clinical Laboratory Test Results|Clinically significant changes|Up to 3 years|||participants|||Number
10849|NCT02002936|Secondary|Overall Survival|Survived|Up to 3 years|||participants|||Number
10850|NCT02002936|Secondary|Cytogenetic Response Ratio According to IWG 2006 Criteria|"Ratio of patients scored as complete cytogenetic response or partial cytogenetic response) according to IWG 2006 criteria. Definitions of complete cytogenetic response and partial cytogenetic response is shown below.~Complete cytogenetic response:~Disappearance of chromosomal abnormality, without appearance of any new karyotype abnormalities~Partial cytogenetic response:~≤50% reduction compared to base-line"|Up to 3 years||||||
10851|NCT02002936|Secondary|Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.|"Ratio of patients scored as hematologically improved erythrocyte lineage, platelet lineage, or neutrophil lineage according to IWG 2006 criteria.Definition of hematologic improvement is shown below.~Hematologic improvement-erythroid (base-line <11 g/dL):~≥1.5 g/dL increase in Hb. Decrease of ≥4 units/8 weeks in blood transfusion volume compared to base-line (only cases of blood transfusion given for Hb ≤9 g/dL will be assessed based on transfusion volume)~Hematologic improvement-platelet (base-line <100,000/µL):~Cases with ≥20,000/µL: ≥30,000/µL increase compared to base-line. Cases with <20,000/µL: Increase to ≥20,000/µL, with at least a 2-fold increase in base-line level~Hematologic improvement-neutrophil (base-line <1,000/µL):~At least a 2-fold increase in base-line level, to ≥500/µL"|Up to 3 years||||||
10852|NCT02002936|Secondary|Total Efficacy in Hematologic Remission (IWG2006 Criteria)|SD (stable disease)|Up to 3 years|||participants|||Number
10853|NCT02002936|Primary|Adverse Events|Total number affected by any adverse events (details are presented in adverse event section)|Up to 3 years|||participants|||Number
10854|NCT02002871|Other Pre-specified|Number of Participants With Acceptance of Hyperpigmentation at Week 6|"Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering yes or no."|week 6|7 patients out of 20 patients reported hyperpigmentation at week 6.||participants|||Number
10860|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Patient Rating of Itching of the Target Area as Compared to the Control Area at End of Follow-up|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).|week 6|||units on a scale||Standard Deviation|Mean
10861|NCT02002871|Secondary|Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)|week 4, 6|||units on a scale||Standard Deviation|Mean
10862|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area at End of Follow-up|Higher values describe a higher level of erythema.|week 6|||arbitrary units||Standard Deviation|Mean
10863|NCT02002871|Secondary|Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area|Higher values describe higher erythema levels.|week 4, 6|||arbitrary units||Standard Deviation|Mean
10864|NCT02002871|Secondary|Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|week 6|||units on a scale||Standard Deviation|Mean
10865|NCT02002871|Primary|Change From Baseline (Visit 2) of the Sum Score of Local Eczema Rating of the Target Area as Compared to the Control Area at End of Treatment|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|at week 4|Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient.||units on a scale||Standard Deviation|Mean
10866|NCT02002702|Secondary|Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14|Neutrophil gelatinase-asc lipocalin (NGAL) biomarker was used to assess the effect of serelaxin on kidney function. Geometric means of the ratio of post-Baseline values to baseline values of NGAL was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
10867|NCT02002702|Secondary|Change From Baseline in NT-proBNP Levels Through Day 14|NT-proBNP biomarker was used to assess the effect of serelaxinin on degree of cardiac wall stress and congestion. Geometric means of the ratio of post-Baseline values to baseline values of NT-proBNP was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
10868|NCT02002702|Secondary|Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14|High sensitivity Troponin-T biomarker was used to assess the effect of serelaxin on myocardial damage. Geometric means of the ratio of post-Baseline values to baseline values of high sensitivity troponin-t was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
10869|NCT02002702|Secondary|Change From Baseline in Cystatin-C Levels Through Day 14|Cystatin-C biomarker was used to assess the effect of serelaxinin on worsening of renal function. Geometric means of the ratio of post-Baseline values to baseline values of Cystatin-C was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
10870|NCT02002702|Secondary|Change From Baseline in Aldosterone Levels Through Day 14|Aldosterone biomarker was used to assess the effect of serelaxinin on fluid retention. Geometric means of the ratio of post-Baseline values to baseline values of aldosterone was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.||Ratio||95% Confidence Interval|Geometric Mean
10871|NCT02002702|Secondary|Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5|"The area under the curve (AUC) was defined as area under the plasma concentration-time curve from time zero to time of the last time point with measurable concentration, calculated by a trapezoidal method. Systolic blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 3 minutes at clinic during the visit. Sample collected at: Baseline; 30 & 60 minutes and then every hour for the first 6 hours of study drug infusion, and then every 3 hours during 48 hours of study drug infusion; every 3 hours until 12 hours following end of infusion, then every 6 hours for 48 hours and then every 24 hours until the earlier of Day 5 or discharge.~AUC for SBP is standardized by dividing by the length of respective time ranges."|Baseline, 48 hours, Day 5|The analysis was performed in the full analysis set (FAS) population, defined as all participants who were randomized in the study.||mmHg||Standard Error|Least Squares Mean
10872|NCT02002702|Primary|Concentration at Steady-state (Css) of Serelaxin|Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."||ng/mL||Standard Deviation|Mean
10873|NCT02002702|Primary|Weight Adjusted Clearance (CL) of Serelaxin|Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."||mL/hr/kg||Standard Deviation|Mean
10874|NCT02002702|Primary|Maximum Plasma Concentration (Cmax) of Serelaxin|Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the pharmacokinetic (PK) set, defined as all participants who received study treatment and had at least one evaluable PK parameter data. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."||nanogram(s)/milliliter (ng/mL)||Standard Deviation|Mean
10875|NCT02002702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.|From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)|The analysis was performed on the safety population, defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment.||participants|||Number
10876|NCT02002689|Secondary|Kaplan-Meier Estimates of Progression Free Survival (PFS )Timing, Months||4 months|||months||95% Confidence Interval|Median
10877|NCT02002689|Secondary|Summary of Timing and Estimated Rate for Progression-free Survival (PFS) – Full Analysis Set|Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.|4 months|Full Analysis set||% progression free surviors||95% Confidence Interval|Number
10878|NCT02002689|Primary|Summary of Overall Response (ORR) and Clinical Benefit (CBR)|Clinical benefit rate (CBR) Number and percentage of subjects with CBR (responses of CR, PR or SD ≥ 16 weeks) as assessed by investigator was reported for all patients along with 95% exact confidence interval (CI). Overall Response Rate (ORR) Overall response was to be determined by investigator assessment for each tumor in the study. For subjects with solid tumors, the assessment criteria was RECIST 1.1 and included responses of CR and/or PR. The number and percentage of subjects for different categories of overall response (e.g., for solid tumors – CR, PR, SD, PD, Not Evaluable) were to be provided for solid tumors, and each hematological tumor type (if applicable). Ninety-five percent (95%) exact CI was to be provided for the response rate(s) (e.g., for solid tumors – CRn and/or PR) as well.|16 weeks|Full analysis set||percent responders|||Number
10879|NCT02002650|Secondary|Moderate-to-severe Pancreatitis|Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).|30 days|||participants|||Number
10880|NCT02002650|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.|30 days|||participants|||Number
10881|NCT02002221|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.||Participants|||Number
10882|NCT02002221|Secondary|Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia|Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.||Participants|||Number
10883|NCT02002221|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement. Number of patients with observations at both baseline and endpoint are analyzed in this endpoint.||mg/dL||Standard Error|Least Squares Mean
10884|NCT02002221|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.||percentage of patients|||Number
10929|NCT01998906|Secondary|Overall Survival|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||months||95% Confidence Interval|Median
10885|NCT02002221|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
10886|NCT02002208|Secondary|Rate of Flares||over 16 weeks|||flares||Standard Deviation|Mean
10887|NCT02002208|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16|The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1–1.0 almost clear; 1.1–7.0 mild; 7.1–21.0 =moderate; 21.1–50.0 severe; 50.1–72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.|EASI was measured at baseline (week 0) and 16 weeks after dosing.|Adjusted mean change from baseline EASI at Week 16||units on a scale||Standard Error|Mean
10888|NCT02001181|Secondary|Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4|The EASI Clinical Signs Severity Sum Score was derived from the EASI. The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region. The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.||units on a scale||Standard Deviation|Mean
10889|NCT02001181|Secondary|Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4|The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks. In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. What is reported is the percent change from baseline in BSA affected.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.||percent change||Standard Deviation|Mean
10890|NCT02001181|Secondary|Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.||percentage of participants|||Number
10891|NCT02001181|Secondary|Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.||percentage of participants|||Number
10892|NCT02001181|Primary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4|The EASI quantifies the severity of a participant’s atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.|Baseline (pre-dose on Day 1) and Week 4|The full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.||percent change||Standard Error|Least Squares Mean
10893|NCT02000973|Secondary|Bispectral Index Score|The bispectral index(BIS) score of each patient was recorded at two different time points. BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|Before starting anesthesia to finishing endotracheal intubation|||units on a scale||Standard Deviation|Mean
10894|NCT02000973|Secondary|Heart Rate|The heart rate of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation|||beats per minute||Standard Deviation|Mean
10895|NCT02000973|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation|||mmHg||Standard Deviation|Mean
10896|NCT02000973|Primary|Propofol Effect-site Concentration|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|Before starting anesthesia to finishing endotracheal intubation|||ug/ml||Standard Deviation|Mean
10897|NCT02000752|Secondary|Degree of Ease With Which the Acupuncturist Administered the Treatment|"The degree of ease with which the acupuncturist administered the treatment was measured in a survey that the midwife carries out no more than 2 hours after the labor. The value was recorded using a numerical scale ranging between 0-100, with 4 levels: 100 - high ease, 75 - moderate ease, 50 - medium ease and 25 - low ease"|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room|||units on a scale||Standard Deviation|Mean
10898|NCT02000752|Secondary|Percentage of Mothers That Would Recommend the Technique to Any of Her Friends|"The number of mothers that would recommend the technique to any of her friends is analyzed in the survey that the midwife carries out no more than 2 hours after the labor. The possible responses are I would recommend it, or I would not recommend it."|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room|||percentage|||Number
10899|NCT02000752|Secondary|Percentage of Participants Who Reported Experiencing Pain Related to Treatment|The existence of pain related to the treatment is analyzed by the survey that the midwife carries out no more than 2 hours after the labor. A scale with 4 levels was used (no pain, mild pain, moderate pain, great pain).|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room|||percentage|||Number
10900|NCT02000752|Primary|The Principal Outcome of the Study is the Placental Expulsion Time.|This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.|Up to 30 minutes after the newborn delivery|||minutes||95% Confidence Interval|Mean
10901|NCT02000531|Secondary|Participants With Adverse Events||start of second-line treatment to data cut-off in December 2014 (within 12 months)|Safety Population, defined as all participants enrolled in this extension study||participants|||Number
10902|NCT02000531|Primary|Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events|Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.|within 3 years, 9 months (data cut-off December 2014)|Intention to treat population, defined as all participants enrolled in this extension study||Months||95% Confidence Interval|Median
10903|NCT01999894|Primary|Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)|Number of patients who experienced one or more TEAEs during the study|From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)|The Safety Population consists of 102 enrolled patients who received at least one dose of study drug.||participants|||Number
10904|NCT01999348|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment.||participants|||Number
10905|NCT01999348|Secondary|Percentage of Patients Prescribed by the Physician to Continue Treatment|The percentage of participants who continued treatment with Ganfort® UD after Week 12.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||percentage of participants|||Number
10906|NCT01999348|Secondary|Percentage of Patients Who Discontinued Treatment|The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit|12 Weeks|Per-protocol population included all treated participants who had no major protocol violations.||percentage of participants|||Number
10907|NCT01999348|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|The physician assessed the patient’s tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||participants|||Number
10908|NCT01999348|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||participants|||Number
10909|NCT01999348|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale|The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.|Baseline, Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.||participants|||Number
10910|NCT01999348|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).|Baseline, Final Visit (Week 8 to 12)|Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses.||mmHg||Standard Deviation|Mean
10911|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 96h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|96h after application of ESAT6-CFP10|||participants|||Number
10912|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 72h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|72h after application of ESAT6-CFP10|||participants|||Number
10913|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 48h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|48h after application of ESAT6-CFP10|||participants|||Number
10930|NCT01998906|Primary|Percentage of Participants Event Free at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
10914|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 24h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|24h after application of ESAT6-CFP10|||participants|||Number
10915|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 2h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|within 2h after application of ESAT6-CFP10|Induration and/or redness is our main immune response of ESAT6-CFP10.||participants|||Number
10916|NCT01999231|Primary|the Cases of Adverse Events With Participant Injection of ESAT6-CFP10|The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .|within 7 days after the injections|ESAT6-CFP10 allergen similar to TB-PPD(Tuberculin purified protein derivative ), main ingredients are protein and can cause specific skin allergy in the injection site ( such as redness, swelling, induration, blisters), besides other local reactions, is still listed as adverse events .||cases|||Number
10917|NCT01998919|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Date of randomization until date of death or date of last follow-up assessment|FAS Population||weeks||95% Confidence Interval|Median
10918|NCT01998919|Secondary|Progression-Free Survival (PFS)|PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population||weeks||95% Confidence Interval|Median
10919|NCT01998919|Secondary|Time to Progression|Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population||weeks||95% Confidence Interval|Median
10920|NCT01998919|Secondary|Duration of Response|Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases|FAS; only participants with CR or PR were included in the analysis.||weeks||95% Confidence Interval|Median
10921|NCT01998919|Secondary|Percentage of Participants With Confirmed CR or PR as Assessed by RECIST|CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS||percentage of participants||95% Confidence Interval|Number
10922|NCT01998919|Secondary|Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST|Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.|Week 16|FAS||percentage of participants||95% Confidence Interval|Number
10923|NCT01998919|Primary|Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.|Week 8|FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.||percentage of participants||95% Confidence Interval|Number
10924|NCT01998906|Secondary|Percentage of Participants Surviving at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
10925|NCT01998906|Primary|Percentage of Participants Event Free at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
10926|NCT01998906|Secondary|Percentage of Participants Surviving at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
10927|NCT01998906|Primary|Percentage of Participants Event Free at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
10928|NCT01998906|Secondary|Percentage of Participants Surviving at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants||95% Confidence Interval|Number
10931|NCT01998906|Primary|Event-Free Survival|The median time, in months, between randomization and date of documented occurrence of an EFS event.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||months||95% Confidence Interval|Median
10932|NCT01998906|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS||percentage of participants|||Number
10933|NCT01998906|Secondary|Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.|BL, Presurgery: Day 1 of Cycles 1-10|FAS||percentage of participants||95% Confidence Interval|Number
10934|NCT01998906|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS||percentage of participants||95% Confidence Interval|Number
10935|NCT01998906|Secondary|Percentage of Participants With Breast Pathological Complete Response (bpCR)|bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS||percentage of participants||95% Confidence Interval|Number
10936|NCT01998906|Primary|Event-Free Survival (EFS) - Percentage of Participants With an Event|EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.|Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm.||percentage of participants|||Number
10937|NCT01998893|Secondary|Number of Participants With a Clinical Response to Re-Treatment|Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).|Participants in the ITT population who began a second cycle of treatment.||participants|||Number
10938|NCT01998893|Secondary|Overall Survival (OS)|OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||months||95% Confidence Interval|Median
10939|NCT01998893|Secondary|Time to Progression|The median time, in months, from the start of treatment (first application) until detection of PD.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||months||95% Confidence Interval|Median
10940|NCT01998893|Secondary|Duration of Remission|Median time, in months, between the documentation of CR or PR and PD in clinical responders.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|Participants in the ITT population with CR or PR after the first treatment cycle.||months||95% Confidence Interval|Median
10941|NCT01998893|Secondary|Time to Best Response|The median time, in months, from start of the treatment (first application) until best response (PR or CR).|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population; only participants with at least one application of study treatment within the first 4 weeks of treatment were included in the analysis.||months||95% Confidence Interval|Median
10942|NCT01998893|Secondary|Number of Participants With a Clinical Response|Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||participants|||Number
10943|NCT01998893|Primary|Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)|Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population||percentage of participants||95% Confidence Interval|Number
10944|NCT01998880|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 CLL cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 15.2 months)|Participants from the Intent-to-treat population (all randomized participants) with MRD data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
10945|NCT01998880|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 15.2 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
10946|NCT01998880|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.||Months||95% Confidence Interval|Median
10947|NCT01998880|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.||Months||95% Confidence Interval|Median
10948|NCT01998880|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
10949|NCT01998880|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.||Months||95% Confidence Interval|Median
10950|NCT01998581|Secondary|Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire|Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with data at both time points and received at least 1 treatment||Scores on a Scale||95% Confidence Interval|Mean
10996|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|3 wks postoperative||||||
10997|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|Preoperative 2-8 wks||||||
10951|NCT01998581|Secondary|Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only.|Baseline, Month 3|Subjects in the JUVEDERM VOLBELLA® XC group who received treatment in perioral lines with a baseline POLSS score of moderate or severe||Percentage of Subjects||95% Confidence Interval|Number
10952|NCT01998581|Primary|Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale|Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with a Lip Fullness Scale 2 baseline score of minimal, mild, or moderate and who received at least 1 treatment||Scores on a Scale||Standard Deviation|Mean
10953|NCT01998438|Other Pre-specified|Rate of Reexploration for Bleeding||on the 7th day postoperatively||||||
10954|NCT01998438|Secondary|Number of Participants Needs Allogenic Transfusion||on the 7th day postoperatively||||||
10955|NCT01998438|Primary|Postoperative Blood Loss||24hrs postoperatively|||ml||Inter-Quartile Range|Median
10956|NCT01998399|Other Pre-specified|Discharge Disposition|(Home, other facility, with or without assisted ventilation)|90 days||||||
10957|NCT01998399|Other Pre-specified|Hospital Length of Stay|In days|90 days||||||
10958|NCT01998399|Other Pre-specified|ICU Length of Stay|Includes ICU readmission if during same hospital stay|90 days||||||
10959|NCT01998399|Other Pre-specified|Need for Dialysis|Yes, No|90 days||||||
10960|NCT01998399|Other Pre-specified|Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support)|Yes, No|90 days||||||
10961|NCT01998399|Other Pre-specified|Time to Initiation of Unassisted Breathing|Only in patients on mechanical ventilation and assuming patient achieves 48 consecutive hours of unassisted breathing|90 days||||||
10962|NCT01998399|Secondary|Myocardial Infarction|Did the patient have a myocardial infarction during the 90 day study?|90 days||||||
10963|NCT01998399|Secondary|Composite Endpoint: Stroke, Myocardial Infarct, Mortality||90 days||||||
10964|NCT01998399|Secondary|Stroke|Did the patient develop a stroke during the 90 day study?|90 days||||||
10965|NCT01998399|Secondary|Hospital Free Days|Number of days the patient is not in the hospital|60 days||||||
10966|NCT01998399|Secondary|In-hospital Mortality|Did the patient die during the hospitalization?|Throughout hospitalization||||||
10967|NCT01998399|Secondary|Ventilator Free Days||28 days||||||
10968|NCT01998399|Secondary|Shock Free Days|Not requiring pressor support for hypotension|14 days||||||
10969|NCT01998399|Primary|All-cause Mortality|Alive or dead on day 90|90 day|number of patients that completed the study was too low for a valid statistical analysis||participants|||Number
10970|NCT01998360|Secondary|Cosmetic Result|"Regular: scar line straight without any irregularity~Irregular: Some irregularity to scar line~Scalloped: wavy appearane to scar line"|6 weeks|||participants|||Number
10971|NCT01998360|Secondary|Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks|The number of participants with complete epithelialization (completely healed) at 4 weeks|1 month|||participants|||Number
10972|NCT01998360|Secondary|Blood Loss|Number of ml of blood lost during the procedure, as assessed by the surgeon|During procedure (up to 1 hour)|||ml||Inter-Quartile Range|Median
10973|NCT01998360|Secondary|Number of Participants With Adverse Events|Bleeding, hematoma, infection and other rare adverse events|1 month|||participants|||Number
10974|NCT01998360|Primary|Intraoperative Duration|The number of minutes required to perform the surgical procedure|1 hour|||Min||Inter-Quartile Range|Median
10975|NCT01998269|Primary|Measure of Medication Self-Management (MeDS)|The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.|cross-sectional, 1 hour interview after clinic visit|||units on a scale||Standard Deviation|Mean
10976|NCT01997905|Secondary|Overall Adverse Event Rate|Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure|All treated patients.||participants|||Number
10977|NCT01997905|Secondary|Overall Serious Adverse Event Rate|Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month Post Index Procedure|All treated patients.||participants|||Number
10978|NCT01997905|Secondary|Serious Device or Procedure Related Adverse Event Rate|Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure|||participants|||Number
10979|NCT01997905|Secondary|Rate of Stroke and Non-CNS Systemic Embolism|"The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure:~Stroke (ischemic )~Non-CNS (Central Nervous System) systemic embolism."|3 months and 6 months post-index procedure|||participants|||Number
10980|NCT01997905|Primary|Composite Left Atrial Appendage Placement and Exclusion Success|"Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:~Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.~Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and <10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE.~3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and < 10mm residual pocket) between the LA and LAA at >=3 month TEE or CTA evaluation."|Immediate to 3-months post-index procedure|Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient.||participants|||Number
10981|NCT01997905|Primary|Number of Serious Adverse Events Within 30 Days Post-Index Procedure|"The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator:~Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip~Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke~Major bleeding (defined as requiring re-operation and/or transfusion (> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure)."|30 days post-index procedure|||participants|||Number
10982|NCT01997892|Secondary|Percentage of Participants With Hemoglobin Excursions|The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods.|Month -3, -2, -1, 1, 2, 3, 4, 5 and 6|Primary analysis set||percentage of participants||95% Confidence Interval|Number
10983|NCT01997892|Secondary|Hemoglobin Concentration Rate of Change by Period|The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant.|Thre months prior to switch and 6 months after the switch|Primary Analysis Set with available data||g/dL/4 week||Standard Deviation|Mean
10984|NCT01997892|Secondary|Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa|Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (μg darbepoetin alfa per 1 μg pegylated-epoetin beta).|Week -1 and Week 1|Primary analysis set||ratio||95% Confidence Interval|Geometric Mean
10985|NCT01997892|Secondary|Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month 1, 2, 3, 4, 5 and 6|"Primary analysis set; participants with available data at each time point (as indicated by n)."||μg/week||95% Confidence Interval|Geometric Mean
10986|NCT01997892|Secondary|PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month -3, Month -2, Month -1|"Primary analysis set; participants with available data at each time point (indicated by n)."||μg/week||95% Confidence Interval|Geometric Mean
10987|NCT01997892|Primary|Hemoglobin Concentration at Monthly Intervals|Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.|Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)|"Primary analysis set; participants with available data at each time point (indicated by n)."||g/dL||Standard Deviation|Mean
10988|NCT01997723|Other Pre-specified|Percentage of Participants Who Prefer Home Testing Over Laboratory Testing|Participants indicated which test (PM or PSG) they preferred.|1 week|||percentage of participants|||Number
10989|NCT01997723|Secondary|Technical Failure Rate|home PM tests that failed to provide technically adequate data for diagnosis. Technical failure(s) were tests where estimated total sleep time (TST) was ≤ 2 hours or portable monitor data of interpretable quality was less than 4 hours per recording.|4 days|||percentage of recordings|||Number
10990|NCT01997723|Primary|Apnea Hypopnea Index (AHI)|"AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep.~AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG)."|4 days|The polysomnography area under the curve (AUC) in an ROC plot for this study was assumed to be 0.99. The AUC for home PM test was targeted at 0.88 based on published report for power of 0.90 in a population with estimated pretest probability of 75-85%, ascertained by Berlin Questionnaire.||events per hour||Standard Deviation|Mean
10991|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|6 months postoperative||||||
10992|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|3 months postoperative||||||
10993|NCT01997567|Secondary|Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|Preoperative 2-8 wks||||||
10994|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|6 months postoperative||||||
10995|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|3 months postoperative||||||
10998|NCT01997437|Primary|Number of Mononuclear Cells (MNCs) Per ml|MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.|1 time before seeding on scaffold|||MNCs per ml||Standard Error|Mean
10999|NCT01997437|Secondary|Number of Disease Free Survival Patients|The disease free survival of patient were evaluated after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up|||participants|||Number
11000|NCT01997437|Secondary|Number of Survival Patients|To evaluate the survival of patient after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up|||participants|||Number
11001|NCT01997437|Primary|Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold|Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up|12 months post operative follow up|||participants|||Number
11002|NCT01997398|Secondary|Parkinson's Disease Quality-39 Score (PDQ-39)|"Effects on PDQ-39 scores 6 months following asleep DBS surgery as compared to pre-operative scores. Data from the PDQ-39 can be presented either subset scores or as a single total score. PDQ-39 measures patient quality of life indicators including mobility, activities of daily living, emotional well being, stigma, communication and bodily discomfort. Data from the PDQ-39 can be presented in either subset scores or as a single total score. The full range of the total PDQ-39 scores is from 0 ( no patient related symptoms, or quality of life unaffected) to 156 ( relates having symptoms , or low quality of life).~The subset score ranges are as follows:~mobility: 0 (no patient related symptoms) to 40 (highest patient related symptoms). activities of daily living: 0 to 24; emotional well being: 0-24; stigma: 0-16; cognition: 0-16; communication: 0-12; bodily discomfort: 0-12."|pre-operatively and 6 months post-operatively|||units on a scale||Standard Deviation|Mean
11003|NCT01997398|Primary|"Off and On Medication Unified Parkinson's Disease Rating III Score (UPDRS)"|"A movement disorders clinician who had completed the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) training performed prospective baseline and 6-month postoperative assessments of motor function using the MDS modified UPDRS III on patients during both off-medication (PD medications held for 12 h) and on-medication states.~UPDRS III motor scores range from 0 (no motor function deficit) to 132 (highest motor function deficit). There were no subscales."|pre-operatively and 6 months post-operatively|||units on a scale||Standard Deviation|Mean
11004|NCT01997216|Secondary|Mean Monocular Over-refraction (OR) at Distance|OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.|Up to Hour 9|All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability.||diopter||Standard Deviation|Mean
11005|NCT01997216|Secondary|Mean Binocular HC/HI Visual Acuity at Distance|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.||logMAR||Standard Deviation|Mean
11006|NCT01997216|Primary|Mean Binocular HC/HI Visual Acuity at Near (40 cm)|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.||logMAR||Standard Deviation|Mean
11007|NCT01996904|Secondary|Ultrasound Diagnosis|US is a diagnostic imaging technique used to visualise deep structures of the body by recording the echoes of pulsed ultrasonic waves directed into the tissues and reflected by tissue planes to the transducer. These echoes are converted into 'pictures' of the tissues under examination. It consists of a non-invasive examination that has practically no adverse effects and allows dynamic visualisation of the tendons during movement of the shoulder.|every three months after the surgery until the 24th month||||||
11008|NCT01996904|Primary|ASES Score|The ASES is a 100-point scale which is divided in two sections. Fifty points of which are derived from patient self-report of pain and the other 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living .The item related to pain is evaluated by a VAS (10 cm) that ranges from 0 (no pain at all) to 10 (pain as bad as it can be). The ten activities of daily living include skills such as putting on a coat, sleeping on the affected side, wash back/do up bra in back, manage toileting, combing one's hair, reach a high shelf, lift 10lbs above shoulder,throw a ball overhand,do usual work and do usual sport.The items related to function are evaluated by a four-point Likert scale. The scores of the pain and function subsections are transformed in percentages and each one represents 50% of the final score, which can range from 0 (absence of function) to 100 (normal function).|24th month|||units on a scale||Standard Deviation|Mean
11009|NCT01996813|Secondary|Length of Cerebral Desaturation Event|The length of time of each cerebral desaturation event (CDE) will be recorded for each occurrence.|will be assessed intraoperatively|||seconds|||Number
11010|NCT01996813|Primary|Incidence of Intraoperative Cerebral Desaturation Event|The primary outcome measure will be to determine if the application of compression hose on the legs of obese patients will have an impact on the incidence of cerebral desaturation events during shoulder arthroscopy in the beach chair position.|will be assessed intraoperatively|||participants|||Number
11050|NCT01994629|Secondary|Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 to Day 29 or Day 1 to Day 180 post-vaccination|Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.||Subjects|||Number
11011|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Dryness at Day 90|"As reported and interpreted by the subject on a questionnaire. The subject was asked During a typical day in the past 2 weeks, how often did your eyes feel dry? and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly)."|Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
11012|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Grittiness at Day 90|"As interpreted and reported by the subject on a questionnaire. The subject was asked, During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses? and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly)."|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||units on a scale||Standard Deviation|Mean
11013|NCT01996709|Secondary|"Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90"|As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||percentage of subjects|||Number
11014|NCT01996709|Primary|Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90|Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.|Baseline (Day 0), Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
11015|NCT01996410|Primary|MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment|"The investigators will first plot M.D. Anderson Symptom Inventory Core Items (MDASI) scores over time for the acupuncture and control groups to visually inspect for differences between the two groups. The investigators will further evaluate the difference in MDASI scores for the two groups using linear mixed models that account for multiple measurements within a single patient. A mixed model is preferable to a repeated measures ANOVA in this case, as it allows for missing time points within a single subject without eliminating that subject from the analysis.~Additionally, the investigators are able to specify how our time points are correlated within patients rather than assuming equal correlation across time points. The MDASI is comprised of 13 separate items that are not summative; therefore, the significance level for all statistical tests will be set at 0.003 (0.05/13) to account for multiple comparisons."|15 months|Per IRB guidelines, we were not permitted to analyze the 10 patients enrolled since we did not meet completed enrollment numbers.|||||
11016|NCT01996332|Secondary|Overall Survival (OS) by Line of Treatment|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date [if death date was unavailable] minus the date of first dose of study medication plus 1 divided by 30.44).|Baseline, every 6-8 weeks up to 3 years, or until death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line||months||95% Confidence Interval|Median
11017|NCT01996332|Secondary|Percentage of Participants Achieving Clinical Benefit by Line of Treatment|Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response [CR], partial response [PR], or stable disease [SD]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.|Baseline, every 6-8 weeks up to 3 years or until death|Response evaluable population: participants with measurable disease and with matching criteria to have a response assessment; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line||percentage of participants||95% Confidence Interval|Number
11018|NCT01996332|Primary|Time to Disease Progression or Death by Line of Treatment|Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.|Baseline, every 6-8 weeks up to 3 years until disease progression or death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line||months||95% Confidence Interval|Median
11051|NCT01994629|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 (6 hours) to Day 7 post-vaccination|Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).||Subjects|||Number
11019|NCT01996319|Secondary|Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period||Liters||Standard Deviation|Mean
11020|NCT01996319|Secondary|Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period||Liters||Standard Deviation|Mean
11021|NCT01996319|Secondary|Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 20 post treatment initiation were included in this analysis.||Liters||Standard Deviation|Mean
11022|NCT01996319|Secondary|Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 1 post treatment initiation were included in this analysis.||Liters||Standard Deviation|Mean
11023|NCT01996319|Secondary|Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo|Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22, plus baseline day 36 and day 57 data were included in this analysis.||Minutes||Standard Deviation|Mean
11024|NCT01996319|Secondary|Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day|The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day 1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis||Steps/day||Standard Deviation|Mean
11025|NCT01996319|Primary|Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level|Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis.||kcal/day||95% Confidence Interval|Least Squares Mean
11026|NCT01996319|Primary|Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available.||Liters||95% Confidence Interval|Least Squares Mean
11027|NCT01995461|Other Pre-specified|Change From Baseline Pain Medication Need/Use at 6 Months||baseline (pre-1st injection) to 6 months post-1st injection||||||
11028|NCT01995461|Secondary|Change From Baseline Oswestry Disability Index at 6 Months|The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients. The two sections of the Oswestry Disability Index (ODI) used in the present study were those related to walking and standing (sections 4 and 6). For each section, the total possible score is 5 and overall ODI score was expressed as a percentage of the maximum possible score (10). Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection|||points||95% Confidence Interval|Mean
12667|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
11029|NCT01995461|Secondary|Change From Baseline Swiss Spinal Stenosis Score at 6 Months|The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life. The Swiss spinal stenosis (SSS) questionnaire consists of 12 baseline questions asked of all participants prior to injection and an additional 6 questions asked at each time point post-treatment. The initial 12 questions assess reliability and condition at baseline while the 6 post-treatment questions assess treatment satisfaction. All questions ask the patient to assess symptoms over the previous month with a total maximum score for the initial 12 questions of 53 and a total maximum score of 24 for the 6 additional questions. The final total score is expressed as a percentage of the maximum possible score. Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection|||points||95% Confidence Interval|Mean
11030|NCT01995461|Primary|Change From Baseline Pain Score at 6 Months|change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection|baseline (pre-1st injection) to 6 months post-1st injection|||points||95% Confidence Interval|Mean
11031|NCT01995357|Primary|Degree of Leakage|"The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).~Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group."|10 (- 2 days)|||units on a scale||Standard Deviation|Mean
11032|NCT01995136|Primary|Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.|Baseline (Day 0), Week 4, Week 8, Week 12|This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.||mmHg||95% Confidence Interval|Least Squares Mean
11033|NCT01995045|Secondary|Mean Oxycodone Intake|The mean oxycodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)|||milligrams||Standard Deviation|Mean
11034|NCT01995045|Secondary|Mean Hydrocodone Intake|The mean hydrocodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)|||milligrams||Standard Deviation|Mean
11035|NCT01995045|Secondary|Mean Acetaminophen Intake|The mean acetaminophen use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)|||milligrams||Standard Deviation|Mean
11036|NCT01995045|Primary|Mean Pain Score|The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.|Post-Operative Day 1 (Up to 24 hours)|||units on a scale||Standard Deviation|Mean
11037|NCT01994902|Primary|Degree of Leakage|The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).|28 +/- 3 days|The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.||units on a scale|Participants|Standard Deviation|Mean
11038|NCT01994876|Primary|Degree of Leakage|The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)|14 days|||units on a scale|Participants|Standard Deviation|Mean
11039|NCT01994863|Primary|Leakage|The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14+/-3 days per product|Intention-to-treat population||percentage of baseplates with no leakage|Participants||Number
11040|NCT01994746|Secondary|Time to Maximum Concentration (Tmax) of Glucose||0 to 90 minutes following glucagon administration||||||
11041|NCT01994746|Secondary|Maximum Concentration (Cmax) of Glucose||0 to 90 minutes following glucagon administration||||||
11042|NCT01994746|Secondary|Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Glucose From Time Zero up to 90 Minutes||0 to 90 minutes following glucagon administration||||||
11043|NCT01994746|Secondary|Time to Maximum Concentration (Tmax) of Glucagon||0 to 90 minutes following glucagon administration||||||
11044|NCT01994746|Secondary|Maximum Observed Concentration (Cmax) of Glucagon||0 to 90 minutes following glucagon administration||||||
11045|NCT01994746|Secondary|Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Glucagon||0 to 90 minutes following glucagon administration||||||
11046|NCT01994746|Secondary|Time From Glucagon Administration to Return of Plasma Glucose to >/=70 mg/dL||0 to 90 minutes following glucagon administration||||||
11047|NCT01994746|Secondary|Recovery From Symptoms of Hypoglycemia|Recovery from clinical symptoms of hypoglycemia if present as documented using the hypoglycemia symptoms questionnaire which is completed when the plasma glucose reaches <75 mg/dL and at 15, 30, 45 and 60 minutes following administration of glucagon.|plasma glucose <75 mg/dl to 60 minutes following administration of glucagon||||||
11048|NCT01994746|Secondary|Nasal and Non-nasal Effects/Symptoms|Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat will be assessed at 15, 30, 60 and 90 minutes following administration of glucagon.|15 to 90 minutes post glucagon administration||||||
11049|NCT01994746|Primary|Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL|Increase in blood glucose to >=70 mg/dL or an increase of >=20 mg/dL within 30 minutes after receiving glucagon, without receiving additional actions to increase the blood glucose level such as oral or intravenous glucose or additional glucagon.|within 30 minutes after receiving glucagon|||percentage of participants|||Number
11062|NCT01994486|Secondary|Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen|Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)|6/16/2014-7/2/2014|||participants|||Number
12668|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
11052|NCT01994629|Secondary|rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||Titers||95% Confidence Interval|Geometric Mean
11053|NCT01994629|Secondary|Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
11054|NCT01994629|Secondary|Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
11055|NCT01994629|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
11056|NCT01994629|Secondary|hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||Titers||95% Confidence Interval|Geometric Mean
11057|NCT01994629|Secondary|Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer < 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.||percentage of Subjects||95% Confidence Interval|Number
11058|NCT01994629|Secondary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).||percentage of Subjects||95% Confidence Interval|Number
11059|NCT01994629|Primary|Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.|Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.|Day 1 to Day 7 post-vaccination|Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).||Number of Subjects|||Number
11060|NCT01994486|Secondary|Proportion of Subjects With Viral Relapse||1/3/2014-9/8/2014|||participants|||Number
11061|NCT01994486|Primary|Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks|The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.|1/3/2014-4/10/2014|||participants|||Number
11063|NCT01994486|Other Pre-specified|Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose|Assessment of the antiviral efficacy (SVR 12) of combination treatment with telaprevir and sofosbuvir administered for 12 weeks.|4/22/2014-5/6/2014|||participants|||Number
11064|NCT01994486|Secondary|Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007|Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.|1/17/2014-3/26/2014|||ng/mL||Standard Deviation|Geometric Mean
11065|NCT01994486|Primary|Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir|Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.|12 weeks-January 3, 2014- April 10, 2014|Non-cirrhotic Hepatitis C Genotype 1 infected subjects, naive to previous Hepatitis C treatment||participants|||Number
11066|NCT01994291|Other Pre-specified|Number of Participants With Change in Ophthalmoscopy Examination Results in Study Eye After Administration of Ranibizumab or Masked Sham Therapy at Week 8|Ophthalmoscopy ought to be performed after pupillary dilation to examine the vitreous body, optic nerve head, macular and peripheral retina. All findings, including the presence or absence of vitreous inflammation, ought to be documented. All post-dose ophthalmoscopy assessments ought to be made immediately following the administration of ranibizumab or masked sham therapy.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
11067|NCT01994291|Other Pre-specified|Maximum Increase of Intraocular Pressure (IOP) From Baseline in Study Eye|IOP was measured using Goldmann applanation tonometry. To maintain consistency, it was recommended that the same examiner ought to measure IOP with the same tonometer at each visit for a given subject. Intraocular pressure ought to be measured in the study eye approximately 30 minutes after intravitreal injection or masked sham therapy (performed by unmasked study team member).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||mmHg||Standard Deviation|Mean
11068|NCT01994291|Other Pre-specified|Number of Participants With Changes in the Anterior Segment of the Study Eye at Week 12|The anterior biomicroscopy exam was done undilated in order to assess whether there was any anterior segment inflammation caused either by ranibizumab or PF-04634817.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
11069|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=200 msec or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QT interval >=500 msec; and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
11070|NCT01994291|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed for abnormalities at any time point: hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count); blood chemistry (sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase); follicle-stimulating hormone (FSH) (Weeks -5 to 0 only, for postmenopausal women who have been amenorrheic for at least 12 consecutive months prior to screening visit).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
11071|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs|Number of participants who met the categorical summary of post-baseline criteria at any time point, defined as: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine systolic blood pressure (SBP) ≥30 millimeters of mercury (mmHg) change from baseline in same posture; supine diastolic BP (DBP) ≥20 mmHg change from baseline in same posture; supine SBP <90 mmHg; supine DBP <50 mmHg.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
11072|NCT01994291|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 0 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.||participants|||Number
11073|NCT01994291|Secondary|Plasma Concentration of PF-04634817 up to Week 12||Week 0, Week 4, Week 8, and Week 12|All subjects in the full analysis set (FAS) for whom a pharmacokinetic sample was obtained and analyzed. The FAS was defined as all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
11074|NCT01994291|Secondary|Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12|Stereo color fundus photographs using certified digital systems were taken by a photographer who had been pre-certified (“study certified”) by the Central Reading Center. They were evaluated by the Central Reading Center.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||Letters||80% Confidence Interval|Least Squares Mean
11075|NCT01994291|Secondary|Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12|Fluorescein Angiography (FA) using certified digital systems was taken by a photographer who had been pre-certified (“study-certified”) by the Central Reading Center. They were evaluated by the Central Reading Center.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||mm^2||80% Confidence Interval|Least Squares Mean
11076|NCT01994291|Secondary|Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12|A central reading center was used for the evaluation. A photographer or technician pre certified (“study certified”) by the Central Reading Center ought to perform all optical coherence tomography (OCT) imaging. Use of a Spectralis or Cirrus OCT was acceptable.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||microns||80% Confidence Interval|Least Squares Mean
11077|NCT01994291|Secondary|Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated ETDRS charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||proportion of participants|||Number
11078|NCT01994291|Primary|Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.||Letters||80% Confidence Interval|Least Squares Mean
11079|NCT01993888|Secondary|Incidence of Adverse Events That Were Potentially Related to Thrombotic Events|Number of participants with adverse events that were potentially related to thrombic events|Up to 60-days following surgery|||participants|||Number
11080|NCT01993888|Secondary|Incidence of Adverse Events (AEs)||Up to 60-days following surgery|||participants|||Number
11081|NCT01993888|Secondary|Incidence of Re-bleeding Events From the TBS During the Study Follow-up||Up to 60-days following surgery|||participants|||Number
11082|NCT01993888|Secondary|Absolute Time to Hemostasis|The absolute time to achieve hemostasis at or after 4 minutes from randomization.|Intraoperative, an average of 4.2 minutes following randomization|Time to hemostasis (TTH), defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization was evaluated as a secondary endpoint. In one subject in the SoC group, manual compression was not maintained until the 4-minute endpoint, but was released early and a suture was applied, at which point the subject was hemostatic.||minutes||Full Range|Median
11083|NCT01993888|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization|Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.|Intraoperative, 10 minutes following randomization|The proportion of subjects achieving hemostatic success at 10 minutes following randomization was evaluated as a secondary endpoint using the logistic model with treatment and site/institution included in the model.||participants with hemostatic success|||Number
11084|NCT01993888|Primary|Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization|Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.|Intraoperative, 4 minutes following randomization|The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set.||participants with hemostatic success|||Number
11085|NCT01993823|Other Pre-specified|Mycological Study||Day 24||||||
11086|NCT01993823|Secondary|Changes in Signs/ Symptoms|"The secondary efficacy variables include:~Proportion of subjects with signs and symptoms score of “0” at each visit.~Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24.~The changes in signs and symptoms after two (2) weeks of treatment.~The changes in signs/symptoms at Day 24.~The mycological study results obtained in the cultures at day 24.~The number of patients with clinical cure or improvement at day 14 and 24."|2 weeks and 4 weeks|ITT||percentage of patient|||Number
11087|NCT01993823|Primary|Clinical and Mycological Evaluation|Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of “0” on Day 24.|Day 24|ITT||participants|||Number
11088|NCT01993238|Secondary|Pain Scores Reported at 1-day Post-Treatment|During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable).|1 day|Intent-to-Treat||units on a scale||Standard Deviation|Mean
11089|NCT01993238|Secondary|Safety Assessment|Adverse events will be assessed and documented throughout the study|Baseline, 1 day, 1 week||||||
11090|NCT01993238|Primary|Pain Score for Overall Treatment|Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)|Baseline|Intent to Treat||units on a scale||Standard Deviation|Mean
11091|NCT01993030|Primary|Time to Wound Healing|Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||Days||Standard Deviation|Mean
11092|NCT01993030|Secondary|Number of Participants With Exudation|"Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation:~Less than two gauze was soaked by exudation within 24h---No exudation (-);~Two to four gauze was soaked by exudation within 24h---Little exudation (+);~More than four gauze was soaked by exudation within 24h---Much exudation (++);"|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||participants|||Number
11093|NCT01993030|Secondary|Pain Perceived by Patient|The amount of pain that a patient perceived was assessed using a Visual Analogue Scale (VAS 0-10), which ranges across a continuum from 0 (no pain) to 10 (worst pain).|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||units on a scale||Standard Deviation|Mean
11094|NCT01993030|Secondary|Number of Participants With Inflammatory Reaction|Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||participants|||Number
11095|NCT01993030|Secondary|Number of Participants With Growth of Granulation Tissue|Physician assessment of tissue with healthy granulation tissue defined as is granular and uneven in texture, does not bleed easily and is pink in color. Unhealthy granulation tissue is typically dark which can be indicative of poor perfusion, ischemia and/or infection.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation|||participants|||Number
11096|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Progressive Disease (PD)|PD as per RECIST v1.1 defined as 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
11097|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Stable Disease (SD)|SD as per RECIST v1.1 defined as neither shrinkage to qualify for PR nor increase to qualify for progressive disease (PD) taking the smallest sum diameters on study as reference. PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; PD = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
11098|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Partial Response (PR)|PR as per RECIST v1.1 defined as 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
11099|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR)|CR as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 defined as disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm).|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
11100|NCT01992874|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|From the first dose of study drug administration until 30 days after the last dose of study drug administration, assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.||subjects|||Number
11101|NCT01992874|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUC 0-t)|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration was at or above the lower limit of quantification.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
11102|NCT01992874|Secondary|Terminal Rate Constant (λz)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||1/h||Full Range|Median
11103|NCT01992874|Secondary|Apparent Volume of Distribution (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||Liter||Geometric Coefficient of Variation|Geometric Mean
11104|NCT01992874|Secondary|Apparent Total Body Clearance (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
11105|NCT01992874|Secondary|Apparent Terminal Half-life (t1/2)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.||hour||Full Range|Median
11106|NCT01992874|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.||hour||Full Range|Median
11107|NCT01992874|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-inf)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analysed) signifies the number of subjects analysed for this outcome measure.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
11108|NCT01992874|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|Pharmacokinetic (PK) analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
11109|NCT01992536|Secondary|26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.|Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)|From primary parent study completion up to Day 1 in this study.|Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).||Participants|||Number
11110|NCT01992536|Secondary|25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.|Day 1 to Day 365|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.||Participants|||Number
11111|NCT01992536|Secondary|24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.|"Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30.~Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30."|Day 1 through Day 30|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.||Participants|||Number
11112|NCT01992536|Secondary|23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.|From day 1 (6 hours) through day 7 after any vaccination|Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.||Participants|||Number
11113|NCT01992536|Secondary|22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
11114|NCT01992536|Secondary|21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
11115|NCT01992536|Secondary|20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
11116|NCT01992536|Secondary|19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
11117|NCT01992536|Secondary|18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
11118|NCT01992536|Secondary|17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
11119|NCT01992536|Secondary|16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Titers||95% Confidence Interval|Geometric Mean
11120|NCT01992536|Secondary|15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination.~Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
11121|NCT01992536|Secondary|14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
11122|NCT01992536|Secondary|13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.||Percentages of Subjects||95% Confidence Interval|Number
11123|NCT01992536|Secondary|12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.|Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
11124|NCT01992536|Secondary|11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.|Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
11125|NCT01992536|Secondary|10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
11126|NCT01992536|Secondary|9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.~Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
11127|NCT01992536|Secondary|8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Titers||95% Confidence Interval|Geometric Mean
11128|NCT01992536|Secondary|7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Titers||95% Confidence Interval|Geometric Mean
11129|NCT01992536|Secondary|6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.|"The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Titers||95% Confidence Interval|Geometric Mean
11349|NCT01985126|Secondary|Time to Disease Progression|Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression.|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||months||95% Confidence Interval|Median
11130|NCT01992536|Secondary|5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.|"The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Titers||95% Confidence Interval|Geometric Mean
11131|NCT01992536|Secondary|4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|"Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Percentages of Subjects||95% Confidence Interval|Number
11132|NCT01992536|Secondary|3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.|"Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.||Percentages of Subjects||95% Confidence Interval|Number
11133|NCT01992536|Primary|2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.|Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
11134|NCT01992536|Primary|1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.|Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.|Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).||Percentages of Subjects||95% Confidence Interval|Number
11135|NCT01992523|Secondary|Dyspnoea and/or Symptomatic Bradycardia|Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia|6 months|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%)||percentage of partecipants|||Number
11136|NCT01992523|Secondary|Bleeding Events|Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events|48 hours|||percentage of partecipants|||Number
11137|NCT01992523|Secondary|High Residual Platelet Reactivity|The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.|1 hour|Categorical data were expressed as proportions (%)||percentage of partecipants|||Number
11138|NCT01992523|Primary|Residual Platelet Reactivity|residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.|1 hour|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). A P value < .05 was considered statistically significant. All tests were two-sided.||PRU (P2Y12 reaction units)||Inter-Quartile Range|Median
11139|NCT01992185|Primary|Percent Repigmentation||90 days|||Percent Repigmentation||Standard Deviation|Mean
11140|NCT01992172|Primary|Number of Pruritus Events in Last 30 Days||30 days from baseline|||Events||Standard Deviation|Mean
11141|NCT01992107|Secondary|Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.|Day 1 to 210 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data||Subjects|||Number
11142|NCT01992107|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.|Day 1 to 7 after last vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data||Subjects|||Number
11278|NCT01988129|Primary|Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months|Fewer motor vehicle crashes is indicative of better health. We assessed motor vehicle crashes cumulatively over 12 months. Accidents were counted as any incident that resulted in the filing and review of a departmental Fleet Accident Report.|12 months|||incidents/firefighter||Standard Deviation|Mean
11143|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c|"Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
11144|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain|"Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
11145|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c|"Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c.~Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
11146|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
11147|NCT01992107|Secondary|Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age|Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set||Ratios||95% Confidence Interval|Geometric Mean
11148|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70%|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set||percentages of subjects||95% Confidence Interval|Number
11149|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set||percentages of subjects||95% Confidence Interval|Number
11150|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.~The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set (FAS) i.e. all subjects in the enrolled set who received at least one study vaccination and provided immunogenicity data at day 22 (day 50 for not previously vaccinated subjects)||percentages of subjects||95% Confidence Interval|Number
11159|NCT01992094|Secondary|8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1."|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
11151|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.~The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Full Analysis Set (FAS) immunogenicity set i.e. all subjects in the enrolled set who received ▫ Received at least one study vaccination and provided immunogenicity data at day 1 and day 22 (day 50 for not previously vaccinated subjects)||percentages of subjects||95% Confidence Interval|Number
11152|NCT01992107|Primary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on PP population||percentages of subjects||95% Confidence Interval|Number
11153|NCT01992107|Primary|Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.~Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly received the vaccine, had no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis||Titers||95% Confidence Interval|Geometric Mean
11154|NCT01992094|Secondary|13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 181 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data||Subjects|||Number
11155|NCT01992094|Secondary|12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 7 post vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data||Subjects|||Number
11156|NCT01992094|Secondary|11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain|Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
11157|NCT01992094|Secondary|10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain|"Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||Titers||95% Confidence Interval|Geometric Mean
11158|NCT01992094|Secondary|9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain|Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population||percentages of subjects||95% Confidence Interval|Number
11298|NCT01987219|Primary|Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline|The percentage change in respiratory function from baseline is measured in percentage change in Resistance, kPa/(L/s).|Pre and 30 minutes post study drug administration|||percentage change from baseline||Standard Deviation|Mean
11160|NCT01992094|Secondary|7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||percentages of subjects||95% Confidence Interval|Number
11161|NCT01992094|Secondary|6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||percentages of subjects||95% Confidence Interval|Number
11162|NCT01992094|Secondary|5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||Ratio||95% Confidence Interval|Geometric Mean
11163|NCT01992094|Secondary|4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.||percentages of subjects||95% Confidence Interval|Number
11164|NCT01992094|Secondary|3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set i.e. all subjects in the enrolled set who receive the study vaccination and provide immunogenicity data at visit 1 and visit 2||percentages of subjects||95% Confidence Interval|Number
11165|NCT01992094|Primary|2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer|Three weeks post vaccination (Day 22)|Analysis was done on PP population||percentage of subjects||95% Confidence Interval|Number
11166|NCT01992094|Primary|1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.~Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Three weeks post vaccination (Day 22)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis||Titer||95% Confidence Interval|Geometric Mean
11167|NCT01991990|Primary|Absolute Median Fluorescence Intensities of Neutrophil Adhesion Molecules|Neutrophil surface receptor expression may be used to characterize the activation status of neutrophils. Fresh (0 min), PBS control (30 min) and fMLP-stimulated (30 min) PMNs (5 × 10^6 PMNs/mL) were fixed with CellFIX, and 90 μL transferred to each tube containing antibody mixture (2 μL cluster of differentiation [CD] 11b-brilliant violet (BV) 421, 2 μL CD16-FITC, 5 μL CD62L-allophycocyanin (APC) and 5 μL CD162-phycoerythrin [PE]) or isotype control mixture of equivalent volumes. After 30 minutes of incubation on ice and in the dark, cold PBS was added to stop further reaction. Surface marker expressions were quantified by flow cytometry.|Day 4|Safety analysis population||median fluoresence intensity||Standard Error|Mean
11194|NCT01990794|Secondary|Changes in Cardiac Function (LA Volume Index)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||LA volume index (mL/m^2)||Standard Deviation|Mean
11347|NCT01985321|Secondary|Number of Treatment Related Adverse Events||Days 1-28|||participants|||Number
11168|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Microscopic Morphology|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by microscopy with neutrophils classified as shape-changed if they contained > 1 cell surface bleb or irregularity and change from baseline in percentage of neutrophil with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population||percentage of shape changed neutrophils||Standard Error|Mean
11169|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Flow Cytometry (FSC-High Cells)|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring FSC on flow cytometry. Change from baseline in the percentage of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population||percentage of shape changed neutrophils||Standard Error|Mean
11170|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to Nadir in the Number of Neutrophils With Shape Change Measured Using Flow Cytometry|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), phosphate-buffered saline (PBS) control (30 min control) and formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ milliliter [mL]) were fixed with CellFIX (organic solvent used as fixative for adherent cells), 90 microliters (μL) transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring forward scatter (FSC) on flow cytometry. Change from baseline in the number of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population||neutrophils with shape change||Standard Error|Mean
11171|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir in the Percentage of Apoptotic Neutrophils as Measured by Flow Cytometry|Ageing neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of Annexin V (AV) to bind exposed phosphatidylserine. Propidium Iodide (PI) is normally membrane-impermeable but enters cells in late apoptosis when their plasma membrane becomes leaky. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptosis was assessed by flow cytometry with fluorescein isocyanate-labeled recombinant human AV (AV-FITC) and PI staining and the change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by flow cytometry is reported.|Baseline, Day 4|Safety analysis population||percentage of apoptotic neutrophils||Standard Error|Mean
11172|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir (Day 4) in the Percentage of Apoptotic Neutrophils as Measured by Microscopic Morphology|Neutrophil apoptosis was measured using microscopy method with slides stained with Diff-Quik (modified Wright Giemsa stain) and morphology examined under oil immersion light microscopy with 100 times magnification. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptotic neutrophils were characterized with dark and pyknotic nuclei compared to the viable neutrophils. Change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by microscopy is reported.|Baseline, Day 4|Safety analysis population||percentage of apoptotic neutrophils||Standard Error|Mean
11173|NCT01991990|Primary|Neutrophil Respiratory Burst: Change From Baseline to Nadir (Day 4) in the Production of Reactive Oxygen Species as Measured by Chemiluminescence (Relative Light Units - Absolute)|Neutrophils generate a respiratory burst using reactive oxygen species (ROS) to kill invading pathogens. When luminol is used as a substrate for ROS, a chemical reaction is produced resulting in photon emission (chemiluminescence) in primed and unprimed neutrophils following formyl-methionyl-leucyl-phenylalanine (fMLP) stimulation which is quantifiable. fMLP stimulation of the respiratory burst is mediated through activation of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase in primed neutrophils. The maximal fMLP response is observed in primed neutrophils and is an ex vivo measure of the capacity of neutrophils to respond to pathogenic stimuli. In the current experiments, neutrophils were primed with tumor necrosis factor alpha (TNFα). Light emission was recorded on a luminometer. Absolute change from baseline in the production of ROS on Day 4 was reported.|Baseline, Day 4|Safety analysis population||relative light units||Standard Error|Mean
11174|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in Median Fluorescence Intensity (MFI) of eFluor670+ Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4˚C (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the eFluor670+ MFI was calculated on Day 4.|Baseline, Day 4|Safety analysis population||median fluoresence intensity||Standard Error|Mean
11175|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in the Percentage of eFluor670-Positive (eFluoro670+) Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia (S.pneumonia) bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4 degrees(˚) centigrade (C) (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the percentage of eFluor670+ neutrophils was calculated on Day 4.|Baseline, Day 4|Safety analysis population.||percentage of eFlouro+ neutrophils||Standard Error|Mean
11614|NCT01976806|Secondary|Gingival Crevicular Fluid High Sensitivity C-reactive Protein|Gingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.|Baseline and 3 months||||||
11176|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 10|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 10 (6 days post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 10|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.||percentage of Day 4 counts||Standard Error|Mean
11177|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 5|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 5 (24-hours post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 5|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.||percentage of Day 4 counts||Standard Error|Mean
11178|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 4 (Neutrophil Nadir)|On Day 4 participants had neutrophils isolated from 100 milliliters (mL) of acid-citrate dextrose (ACD)-anti-coagulated autologous venous blood and labeled in autologous plasma with up to 2.5 megaBecquerel (MBq) 111 Indium (111In)-tropolonate before being reinjected. Participants rested for 45 minutes (min) post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils on Day 4 (45 min post re-injection) in the blood, liver/spleen and pelvic bone marrow, expressed as percentages of total body counts (TBCs).|Day 4|Safety analysis population: Includes all the participants who received the single dose of randomized study medication. One participant in the polymorphonuclear leukocyte (PMN)-high group was excluded due to external contamination affecting profiling data.||percentage of total body count||Standard Error|Mean
11179|NCT01990859|Secondary|Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response|Best Overall Response Rate (BORR) was defined as the total number of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants (%). A two-sided, exact 95% Confidence Interval (Clopper and Pearson) for the BORR was calculated. Overall response (OR) was determined using modified World Health Organization (mWHO) criteria: Complete Response = complete disappearance of all index and non-index lesions, and no new lesions. Partial Response = decrease in index lesions of 50% or greater in a SPD relative to baseline, and no new lesions. BOR=an overall response of CR or PR at Week 12 or after Week 12.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||percentage of participants||95% Confidence Interval|Number
11180|NCT01990859|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response|Overall response (OR) was determined using modified World Health Organization (mWHO) criteria. Complete response (CR): complete disappearance of all index and non-index lesions, and no new lesions. Partial response (PR): decrease in index lesions of 50% or greater in a sum of the products of diameters (SPD) relative to baseline, and no new lesions. Stable Disease (SD): Does not meet criteria for CR or PR, in the absence of PD in index lesions and no change or any change with persistence of one or more non-index lesions, and no new lesions. Progressive Disease (PD): At least 25% increase in SPD relative to nadir in index lesions and unequivocal progression of non-index lesions, along with new lesions or no new lesions; or PD: new lesions with any response with index or non-index lesions. Not Evaluable: Response cannot be determined.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||participants|||Number
11181|NCT01990859|Secondary|Number of Participants With Renal Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Renal parameter=Creatinine. The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.||participants|||Number
11182|NCT01990859|Secondary|Number of Participants With Liver Function Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Liver Function parameters included: alanine aminotransaminase (ALT), aspartate aminotransferase (AST), Total Bilirubin, and Alkaline Phosphatase (Alk Phos). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.||participants|||Number
11183|NCT01990859|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Hematology parameters included: White Blood Cell Count (WBC), Absolute Neutrophil Count, Platelet Count, Hemoglobin, and Lymphocyte Count (absolute). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.||participants|||Number
11184|NCT01990859|Secondary|Number of Participants Who Died - All Treated Participants|Total number of deaths that occurred in all treated participants by study completion are reported.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||participants|||Number
11185|NCT01990859|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related.|Day 1 to 90 Days after the last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.||participants|||Number
11186|NCT01990859|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).|Day 1 to 90 Days after the last dose, up to May 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized. Data up to May 2014 included.||participants|||Number
11187|NCT01990794|Secondary|Changes in Neurological Function (Velocity)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||m/s||Standard Deviation|Mean
11188|NCT01990794|Secondary|Changes in Neurological Function (Sural Sensory Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||Sural Sensory Amplitude (µV)||Standard Deviation|Mean
11189|NCT01990794|Secondary|Changes in Visual Function (Mean Deviation and PSD)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|||dB||Standard Deviation|Mean
11190|NCT01990794|Secondary|Changes in Visual Function (VFI)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|||VFI (%)||Standard Deviation|Mean
11191|NCT01990794|Secondary|Changes in Visual Function (Cup Volume)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|||mm^3||Standard Deviation|Mean
11192|NCT01990794|Secondary|Changes in Visual Function (Average C:D Ratio)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||ratio||Standard Deviation|Mean
11193|NCT01990794|Secondary|Changes in Visual Function (Average RNFL Thickness)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||Average RNFL thickness (µm)||Standard Deviation|Mean
11195|NCT01990794|Secondary|Changes in Cardiac Function (LVEF)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||LVEF (2D est) (%)||Standard Deviation|Mean
11196|NCT01990794|Primary|Cobalt Serum Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation||µg Co/L||Standard Deviation|Mean
11197|NCT01990794|Secondary|Cobalt Urine Concentrations After Cessation of Cobalt Supplementation|A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.|After cobalt supplementation|"Participants that completed three months of cobalt supplementation and volunteered to do additional urine collections after stopping cobalt supplementation. n represents the number of urine samples analyzd at each time point."||µg/L||Standard Deviation|Mean
11198|NCT01990794|Secondary|Cobalt Urine Concentrations|A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.|During cobalt supplementation|Participants that completed three months of cobalt supplementation||µg/L||Standard Deviation|Mean
11199|NCT01990794|Secondary|Glucose Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||mg/dL||Standard Deviation|Mean
11200|NCT01990794|Secondary|Triglyceride Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation||mg/dL||Standard Deviation|Mean
11201|NCT01990794|Secondary|Total Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation||mg/dL||Standard Deviation|Mean
11202|NCT01990794|Secondary|HDL Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation||mg/dL||Standard Deviation|Mean
11203|NCT01990794|Secondary|Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||U/L||Standard Deviation|Mean
11204|NCT01990794|Secondary|Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||U/L||Standard Deviation|Mean
11205|NCT01990794|Secondary|Creatinine Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||mg/dL||Standard Deviation|Mean
12669|NCT01953328|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
11206|NCT01990794|Secondary|Creatine Creatine Kinase–Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||ng/mL||Standard Deviation|Mean
11207|NCT01990794|Secondary|Ferritin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||ng/mL||Standard Deviation|Mean
11208|NCT01990794|Secondary|Total Iron Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||µg/dL||Standard Deviation|Mean
11209|NCT01990794|Secondary|T4 Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation.Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||ng/dL||Standard Deviation|Mean
11210|NCT01990794|Secondary|Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||mIU/L||Standard Deviation|Mean
11211|NCT01990794|Secondary|Albumin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||g/dL||Standard Deviation|Mean
11212|NCT01990794|Secondary|Protein Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||g/dL||Standard Deviation|Mean
11213|NCT01990794|Secondary|Hematocrit Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||Percentage||Standard Deviation|Mean
11224|NCT01990664|Primary|Proportion of Successfully Re-fitted Subjects|Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.|4 weeks|The analysis population includes all subjects who have completed all study visits without a major protocol deviation.||percentage of Subjects|||Number
11615|NCT01976806|Secondary|Change in Bleeding on Probing (Yes/no)|Bleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.|Baseline and 3 months||||||
11214|NCT01990794|Secondary|Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.||million cells/µL||Standard Deviation|Mean
11215|NCT01990794|Secondary|White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||thousand cells/µL||Standard Deviation|Mean
11216|NCT01990794|Primary|Cobalt Whole Blood Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation||µg Co/L||Standard Deviation|Mean
11217|NCT01990794|Secondary|Changes in Neurological Function (Peroneal Motor Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||Peroneal Motor Amplitude (mV)||Standard Deviation|Mean
11218|NCT01990794|Secondary|Changes in Visual Function|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||mm^2||Standard Deviation|Mean
11219|NCT01990794|Secondary|Changes in Cardiac Function|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||cm||Standard Deviation|Mean
11220|NCT01990794|Secondary|Changes in Audiological Function|Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, ~day 45, ~day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation||dB||Standard Deviation|Mean
11221|NCT01990794|Secondary|Hemoglobin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.||g/dL||Standard Deviation|Mean
11222|NCT01990794|Secondary|Effects on the Immune System|Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and >8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).|0 weeks and three months|Participants that completed three months of cobalt supplementation||units on a scale: stimulation index (SI)||Standard Deviation|Mean
11223|NCT01990794|Secondary|Albumin Bound Cobalt Fraction in Serum|The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.|Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers|Analysis was carried out on the first 12 participants of the study||percentage of total blood cobalt||Standard Deviation|Mean
11778|NCT01972438|Secondary|Number of Systemic and Ocular Toxicities and Adverse Events||Study Duration, up to 24 months|||adverse events|||Number
11225|NCT01990339|Secondary|Frequency of Adverse Events (Adverse Drug Reactions)|Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported.|4 Weeks|Safety analysis set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription were also excluded.||percentage of participants|||Number
11226|NCT01990339|Primary|Subjective Symptom Improvement Rate|Subjective symptoms were evaluated as “Disappeared,” “Improved,” “No change,” “Worsened,” or “Unclear.” These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of “Disappeared” + “Improved”) was calculated for each symptom. The percentage of participants with Improvement by symptom was reported.|Start of treatment and Week 4|Efficacy set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription and 861 patients whose questionnaires were not reviewed at either Week 2 or Week 4 were also excluded.||percentage of participants|||Number
11227|NCT01990261|Secondary|Overall Survival According to Prior Chemotherapy Treatment.|Prior chemotherapy treatment is presented as reported by the investigators.|Up to 12 months|Analysis was performed on all enrolled participants.||days||Standard Error|Mean
11228|NCT01990261|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 12 months|Analysis was performed on all enrolled participants.||percentage of participants|||Number
11229|NCT01990261|Secondary|Overall Survival (OS)|OS is defined as time from first administration of study drug until death from any cause.|Up to 12 months|Analysis was performed on all enrolled participants.||days||Standard Error|Mean
11230|NCT01990261|Primary|Progression Free Survival (PFS) at Month 12|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 12 months)|Analysis was performed on all enrolled participants.||days||95% Confidence Interval|Median
11231|NCT01990261|Primary|Progression Free Survival (PFS) at Month 6|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 6 months)|Analysis was performed on all enrolled participants.||days||95% Confidence Interval|Median
11232|NCT01990261|Primary|Survival Rate at Month 12||Month 12|Analysis was performed on all enrolled participants.||percentage of participants|||Number
11233|NCT01990261|Primary|Survival Rate at Month 6||Month 6|Analysis was performed on all enrolled participants.||percentage of participants|||Number
11234|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 6 month diameter)/6 month diameter × 100.|6 months|||percentage of brachial artery diameter||Standard Deviation|Mean
11235|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 3 month diameter)/3 month diameter × 100.|3 months|||percentage of brachial artery diameter||Standard Deviation|Mean
11236|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline|||percentage of brachial artery diameter||Standard Deviation|Mean
11237|NCT01989572|Secondary|5-year Recurrence Free Survival Rate|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||percentage of participants||95% Confidence Interval|Number
11238|NCT01989572|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||percentage of participants||95% Confidence Interval|Number
11250|NCT01989455|Primary|Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|||μg/mL||Standard Deviation|Mean
11239|NCT01989572|Secondary|Recurrence Free Survival in HLA-A2 Positive Patients|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all HLA-A2 positive patients||months||95% Confidence Interval|Median
11240|NCT01989572|Secondary|Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15|all HLA-A2 positive patients||months||95% Confidence Interval|Median
11241|NCT01989572|Primary|Recurrence Free Survival|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||months||95% Confidence Interval|Median
11242|NCT01989572|Primary|Overall Survival|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility||months||95% Confidence Interval|Median
11243|NCT01989455|Secondary|Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of oral deferiprone. Note: All subjects in the 1000 mg cohort received active product, including the 2 who had received placebo for the intravenous infusion.|From dosing until 24 hours post-dose|The safety population included all subjects who received study product.||participants|||Number
11244|NCT01989455|Secondary|Absolute Bioavailability of Deferiprone|The pharmacokinetic profile was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg*h/mL||Standard Deviation|Mean
11245|NCT01989455|Secondary|Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone|Cmax was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg/mL||Standard Deviation|Mean
11246|NCT01989455|Primary|Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.|From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferiprone|The safety population included all subjects who received study product.||participants|||Number
11247|NCT01989455|Primary|The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Standard Deviation|Mean
11248|NCT01989455|Primary|Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg*h/mL||Standard Deviation|Mean
11249|NCT01989455|Primary|Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Full Range|Median
11251|NCT01989195|Secondary|Heart Rate: SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.~Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)|||Heart Rate change in beats per minute||Standard Deviation|Mean
11253|NCT01989195|Secondary|SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"QRS Duration: SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.~Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)|||Change in QRS Duration in milliseconds||Standard Deviation|Mean
11254|NCT01989195|Primary|COMPARISON OF MYOCARDIAL INFARCTION SIZE MEASUREMENTS USING INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) OR DELAYED GADOLINIUM ENHANCED MRI (DEMRI)|Measured as percentage of myocardial injury volume to the total left ventricular myocardial volume|Day 1 (1 MRI)|||percentage of infarct to Left Ventricle||Standard Deviation|Mean
11255|NCT01989169|Primary|Maximum Plasma Concentration (Cmax) of Midazolam|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
11256|NCT01989169|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/ml||Standard Deviation|Mean
11257|NCT01989169|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
11258|NCT01988857|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period|||Subjects|||Number
11259|NCT01988857|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Days 0-30) post vaccination period|||Subjects|||Number
11260|NCT01988857|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 4 days (Days 0-3) post vaccination period|||Subjects|||Number
11261|NCT01988857|Primary|Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 4 days (Days 0-3) post vaccination period|||Subjects|||Number
11262|NCT01988415|Primary|Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity|Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity|3 Months|The analysis population was all evaluable eyes.||percentage of eyes|Participants||Number
11263|NCT01988415|Primary|Mean Postoperative Spherical Aberration|Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.|3 months|The analysis population was all evaluable eyes.||µm|Participants|Standard Deviation|Mean
11264|NCT01988402|Secondary|Serum Uric Acid Level|Blood test (serum) for uric acid level|day 28|||mg/dl||Standard Error|Mean
11265|NCT01988402|Secondary|Change in Physician Global Assessment of Gout Activity|Physician rated gout activity on a Likert scale 1-10.|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28||||||
11266|NCT01988402|Secondary|Change in Patient Rated Pain Over Time|Patient rated pain on a Likert pain score of 1-10|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28||||||
11267|NCT01988402|Primary|The Primary Outcome Unit of Measurement is Time (in Days) to Resolution of the Acute Gout Attack||1-28 Days|||days||Standard Deviation|Mean
11268|NCT01988129|Secondary|Change Firefighters’ and Families’ Job Satisfaction and Ability to Cope With Extended Work Hours|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters’ and families’ job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.|Baseline to 12 months|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters’ and families’ job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.|||||
11269|NCT01988129|Secondary|Change in Firefighters’ Health, as Determined by General Health Indices;|"The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~A higher health index is indicative of better health. We assessed general health with the question ‘ In general, would you say your health is Excellent/Very good/Good/Fair/Poor?’ and coded the answers from 5-1, respectively."|Baseline to 12 months|Within-subject pre- versus post-study. Only 97/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||units on a scale||Standard Deviation|Mean
11270|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic|"A lower number of times reported sleeping while stopped in traffic is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping while stopped in traffic is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 82/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
11271|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving|"A lower number of times reported sleeping while driving is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported being sleepy while driving is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 81/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
11272|NCT01988129|Other Pre-specified|Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire|Firefighters were instructed to attend a mandatory 30-min education training presentation as operations allowed. Following the education, firefighters were invited and encouraged to complete a voluntary sleep disorders screening questionnaire. This questionnaire used validated, self-report screening tools for Obstructive Sleep Apnea (OSA), moderate to severe insomnia, restless legs syndrome and shift work disorder. All of the respondents who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a local American Academy of Sleep Medicine-certified, partnering sleep clinics if they chose to follow-up. Participants were also free to seek medical follow-up elsewhere. Telephone calls were made to all high risk participants to ensure that they were aware of the results, and to facilitate clinic scheduling. Participants were asked to provide voluntary medical records release consent for tracking diagnoses.|Baseline (Study start)|A total of 431 firefighters completed the sleep disorders screening survey including 416 from the intervention stations and 15 who were temporarily assigned to duty in the intervention stations on the day of the survey. We did not consider these 15 firefighters as a separate population.||participants|||Number
11273|NCT01988129|Primary|Firefighters’ Performance, as Determined by Response Time Over 12 Months|"A lower response time is indicative of better performance.~Following detailed review of departmental procedures and records, we determined that ‘turn-out time’ was already very rapid and not considered an accurate measure of firefighters’ performance by the department. Similarly, ‘clearance time’ (time from the start until the end of the event), which could last for many hours, was also not considered an appropriate measure of firefighter’ performance in relation to sleep and alertness given the multiple factors, many of which are not under the control of the firefighters, that could affect clearance times. We therefore did not address this aim."|12 months|Following review of departmental records, we determined that ‘turn-out time’ and ‘clearance time’ were not appropriate measures of firefighter’ performance in relation to sleep and alertness given the multiple factors that could affect them. We therefore did not address this aim.|||||
11274|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone|"A lower number of times reported sleeping on the telephone is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping on the telephone is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 88/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
11275|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings|"A lower number of times reported falling asleep during meetings is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping during meetings is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 27/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Incidents/month||Standard Deviation|Mean
11276|NCT01988129|Secondary|Change in the Mean Total Sleep Time|"A higher total sleep time is indicative of better sleep. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for total sleep time is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey, and had at least 1 week of work scheduled in the 4 weeks prior to each survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 62/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.||Hours/week||Standard Deviation|Mean
11277|NCT01988129|Primary|Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months|Fewer on-the-job injuries is indicative of better health. We assessed injuries cumulatively over 12 months. Injuries that triggered the filing of an official city government accident report as the result of following normal departmental procedures were included in this study.|12 months|||injury report/firefighter||Standard Deviation|Mean
12670|NCT01953328|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
11279|NCT01988129|Primary|Firefighters’ Health, as Determined by Number of ‘Sick’ Days Over 12 Months|We assessed 'sick days' cumulatively over 12 months in two ways from departmental payroll records; the number of 24-hour pay periods coded as 'sick' time per firefighter and the number of 24-hr pay periods coded as injury and disability per firefighter. Fewer sick days is indicative of better health.|12 months|||days/firefighter||Standard Deviation|Mean
11280|NCT01987765|Primary|Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale|Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.|Baseline, 2 Weeks|Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis.||Scores on a Scale||Standard Deviation|Mean
11281|NCT01987765|Primary|Percentage of Patients Reporting Adverse Events|An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 10 Months|Safety Assessment Population: included all patients who completed the study.||Percentage of Patients|||Number
11282|NCT01987752|Primary|Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.|Baseline, Week 4|Efficacy Population included all participants who received study drug for > 4 weeks and had overall assessment data available.||Percentage of participants|||Number
11283|NCT01987752|Primary|Percentage of Participants Reporting Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 2.6 Years|Safety Population included all participants who received study drug.||Percentage of participants|||Number
11284|NCT01987583|Primary|Diastolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
11285|NCT01987583|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.~Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month||||||
11286|NCT01987583|Primary|Systolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
11287|NCT01987557|Secondary|Static Posturography (Balance/Postural Control)|A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.||||||
11288|NCT01987557|Secondary|Spatiotemporal Aspects of Gait|"Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined.~Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis.~Spotters are always present to ensure safety during this assessment."|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.||||||
11289|NCT01987557|Primary|Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)|"A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure.~The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment)."|Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined|||units on a scale (0-4)||Standard Deviation|Mean
11290|NCT01987453|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement"|Up to posttreatment Week 24|Full Analysis Set||Percentage of participants|||Number
11291|NCT01987453|Secondary|Change in HCV RNA From Baseline||Baseline to Week 8|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
11292|NCT01987453|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Baseline to Week 24|Full Analysis Set||Percentage of participants|||Number
11293|NCT01987453|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||Percentage of participants|||Number
11294|NCT01987453|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 Weeks|Safety Analysis Set||Percentage of participants|||Number
11295|NCT01987453|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Post-treatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug||Percentage of participants|||Number
11296|NCT01987219|Secondary|Change in Forced Expiratory Flow Between 25-75% (FEF25-75)|FEF25-75 is measured in liters of air per second at 25-75%|pre and 30 minutes post intervention|||percentage change from baseline||Standard Deviation|Mean
11297|NCT01987219|Secondary|Change in Forced Expiratory Volume (FEV) From Baseline|Forced expiratory volume is measured in liters of air per second. FEV was measured during the first second of exhalation.|Pre and 30 post study drug admistration|||percentage change from baseline||Standard Deviation|Mean
11299|NCT01987219|Primary|Change From Baseline of Forced Vital Capacity|FVC is a measure of the amount of air exhaled, and is measured in liters of air per second. The percentage in the change in the amount of air exhaled from baseline, measured in liters of air per second. Increase in the percentage of air exhaled from baseline indicates improvement in respiratory function.|Pre and 30 minutes post study drug administration|Per protocol||percentage change from baseline||Standard Deviation|Mean
11300|NCT01986985|Primary|PET/MR Images Clinical Usefulness|Clinically relevant images are obtained|1 day|Subjects with images successfully collected using PET/ MR||Participants|||Number
11301|NCT01986946|Secondary|Wound Infection Rates||during hospitalization (approximately 3-8 days)|Data not collected|||||
11302|NCT01986946|Secondary|Length of Hospital Stay||during hospitalization (approximately 3-8 days)|||days||Standard Deviation|Mean
11303|NCT01986946|Secondary|Number of Participants Readmitted to Hospital Within 30 Days of Surgery||Post-operative Day 30|||participants|||Number
11304|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 3|Participants who were evaluated for Delirium on Day 3||participants|||Number
11305|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 2|Participants who were evaluated for Delirium on Day 2||participants|||Number
11306|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 1|Only participants who had assessment for delirium are include in the analysis.||participants|||Number
11307|NCT01986946|Secondary|Total Post-operative Opioid Consumption||during hospitalization (approximately 3-8 days)|||oral morphine equivilant (mg)||Standard Deviation|Mean
11308|NCT01986946|Secondary|Number of Participants With Adverse Events Related to the Study|Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.|6-week Follow up Visit|||participants|||Number
11309|NCT01986946|Secondary|Number of Participants With Events of Special Interest|Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.|Post-operative Day 30|Data not collected|||||
11310|NCT01986946|Secondary|Patient Satisfaction With Overall Care|Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.||units on a scale||Standard Deviation|Mean
11311|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.||units on a scale||Standard Deviation|Mean
11312|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|Post-operative Day 1|||units on a scale||Standard Deviation|Mean
11313|NCT01986946|Primary|Post-operative Pain as Assessed by Visual Analogue Scale (VAS)|The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|Postoperative day 1|Participant that provided a VAS score at postoperative day 1 time point.||units on a scale||Standard Deviation|Mean
11314|NCT01986790|Primary|Satisfaction|A survey will be administered in order to measure the extent to which participants are satisfied with the information presented to them. Satisfaction was scored on a scale from 1 to 4, with higher scores indicating higher levels of satisfaction. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated satisfaction.||Units on a scale||Standard Deviation|Mean
11315|NCT01986790|Primary|Uncertainty|A survey will be administered in order to measure participants' confidence in the features of health insurance plans that matter most to them and the insurance plan they chose of the ones presented. Confidence in choice is scored on a scale from 0 to 100, with higher scores indicating more decisional conflict/more uncertainty/less confidence in choice. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated uncertainty.||Units on a scale||Standard Deviation|Mean
11316|NCT01986790|Primary|Knowledge|Knowledge measures the degree at which participants understand the details about health insurance plans. Knowledge was scored on a scale from 0 to 7 based on number of correct answers to the 7 items. A higher value is considered to be a better outcome. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated knowledge.||Units on a scale||Standard Deviation|Mean
11317|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group|Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours|Study was prematurely terminated. No data were collected for this assessment|||||
11318|NCT01986751|Secondary|Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.|Comparing the mean time to the first analgesic intake postoperative between the control group and the study group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment|||||
11319|NCT01986751|Secondary|the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.|Comparing the mean hours from start of procedure to discharge between the study group and the control group|baseline to discharge (approximately 72 hours)|Study was prematurely terminated. No data were collected for this assessment|||||
12671|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
11320|NCT01986751|Secondary|Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo|Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.|baseline to discharge from hospital (expected 3 days)|Study was prematurely terminated. No data were collected for this assessment|||||
11321|NCT01986751|Secondary|Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group|Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment|||||
11322|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group|The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment|||||
11323|NCT01986751|Primary|Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group|Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment|||||
11324|NCT01986751|Primary|Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group|Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment.|||||
11325|NCT01986231|Secondary|Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fed state.|Baseline and 41 hours|||g/L||Standard Deviation|Mean
11326|NCT01986231|Primary|Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fasting state.|Baseline and 41 hours|||g/L||Standard Deviation|Mean
11327|NCT01986062|Secondary|PERM-P Scores - Number of Problems Correct|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT||number of problems correct||Standard Deviation|Mean
11328|NCT01986062|Secondary|PERM-P Scores - Number of Problems Attempted|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT||number of problems attempted||Standard Deviation|Mean
11329|NCT01986062|Secondary|SKAMP Subscale - Deportment Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose|||units on a scale||Standard Deviation|Mean
11330|NCT01986062|Secondary|SKAMP Subscale - Attention Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose|||units on a scale||Standard Deviation|Mean
11331|NCT01986062|Secondary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|0.75, 4, 6, 8, 10 hours post-dose|||units on a scale||Standard Deviation|Mean
11332|NCT01986062|Primary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|2 hours post-dose|ITT Population||units on a scale||Standard Deviation|Mean
11333|NCT01985581|Secondary|Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale|CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Subjects who felt very much improved or much improved are considered improved.The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||percentage of subjects|||Number
11348|NCT01985321|Primary|Clinician Assessed Duration of Complete Healing of the Herpetic Episode||Days 1-14|Modified Intent to Treat Population: 2 subjects in placebo group violated protocol and could not be evaluated for Complete Healing (83-2=81). 5 subjects in active group started treatment prior to contacting site; 1 subject in active group lost to follow-up with no site visits. These 6 active subjects not used in Complete Healing analysis (90-6=84)||hours||Full Range|Median
11334|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale|The Clinical Global Impression- Severity scale is a scale of illness ranging from 1 (normal) to 7 (among the most severely ill patients). Subjects who felt normal, not at all ill or borderline mentally ill are considered improved. The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||percentage of subjects|||Number
11335|NCT01985581|Secondary|Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the parent (KINDL-parent). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the parent.|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
11336|NCT01985581|Secondary|Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm|To compare the number of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and incident of Serious Adverse Events (SAEs) in each treatment arm|Measured up to 30 weeks|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||subjects|||Number
11337|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV)|The ADHD-RS-IV is completed by the Investigator familiar with the scale. It is an 18 item scale designed to reflect current symptomatology of ADHD based on the DSM-5 criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, with higher scores reflecting more severe symptoms|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
11338|NCT01985581|Secondary|Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the subject (KINDL-child). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the child|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
11339|NCT01985581|Primary|Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires|The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.|measured at baseline and end of each 12 week treament arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline BRIEF questionnaire during either period 1 or period 2.||units on a scale||Standard Error|Mean
11340|NCT01985425|Secondary|Post-operative Infection||Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
11341|NCT01985425|Secondary|Transient Ischemic Attack (TIA)|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
11342|NCT01985425|Secondary|Stroke|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting more than 24 hours and cerebral imaging consistent with acute stroke.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
11343|NCT01985425|Secondary|Myocardial Injury After Non-Cardiac Surgery (MINS)|"Requires one of the following criteria:~A) Elevated troponin or CK-MB measurement with one or more of the following defining features:~Ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema);~Development of pathologic Q waves present in any two contiguous leads that are >30 milliseconds;~Electrocardiogram (ECG) changes indicative of ischemia (i.e., ST segment elevation [>2 mm in leads V1, V2, or V3 OR >1 mm in the other leads], ST segment depression [>1 mm], OR symmetric inversion of T waves >1 mm) in at least two contiguous leads;~New LBBB; or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging;~B) Elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury"|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
11344|NCT01985425|Secondary|New Onset Atrial Flutter|Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
11345|NCT01985425|Secondary|Death||Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
11346|NCT01985425|Primary|Clinically Significant Atrial Fibrillation|New atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion, or that lasts for longer than 30 seconds.|Post-operative Day 1 until Postoperative Day 30|||Participants|||Count of Participants
11350|NCT01985126|Secondary|Progression Free Survival|Progression free survival was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurred first. Disease progression as per IMWG criteria: increase of >=25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute percent must be >=10 percent; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||months||95% Confidence Interval|Median
11351|NCT01985126|Secondary|Time to Response|Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR [>= 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent] or better).|Up to 14.4 Months|Responders in All Treated Analysis Set. Only those participants with confirmed PR were analyzed.||months||Full Range|Median
11352|NCT01985126|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit rate was defined as the percentage of participants with best response of minimal response (MR) or better (including PR [>= 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent], VGPR [Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour], CR [Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 percent plasma cells in bone marrow], and sCR [CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence]).|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||percentage of participants||95% Confidence Interval|Number
11353|NCT01985126|Secondary|Overall Survival|Overall survival was defined as the time from the date of first dose of daratumumab to the date of the partcipant’s death from any cause.|Up to 14.4 Months|All treated Analysis Set included all participants who received at least 1 dose of daratumumab.||months||95% Confidence Interval|Median
11354|NCT01985126|Secondary|Duration of Response|Duration of response was calculated from the date of initial documentation of a response (PR [>= 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent] or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.|Up to 14.4 Months|Responders in All Treated Analysis Set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
11355|NCT01985126|Primary|Percentage of Participants With Overall Response|Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<)5 percent plasma cells in bone marrow; sCR: CR+Normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than or equal to (>=) 50 percent reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percent; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour.|Up to 14.4 Months|All treated Analysis set included all participants who received at least 1 dose of daratumumab.||percentage of participants||95% Confidence Interval|Number
11356|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11357|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11358|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11359|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11793|NCT01971723|Secondary|Volume Performance Outcomes|During the four weeks, the volume ((weight x reps)set 1+(weight x reps)set 2+ (weight x reps)set 3….. ) will be calculated and measured for each exercise in each lifting session.|4 Weeks|||Repetitions||Standard Deviation|Mean
11360|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11361|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11362|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11363|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11364|NCT01984697|Primary|Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11365|NCT01984697|Primary|Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11366|NCT01984697|Primary|Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11367|NCT01984697|Primary|Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11368|NCT01984697|Primary|Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11369|NCT01984697|Primary|Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11370|NCT01984697|Primary|Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11371|NCT01984697|Primary|Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11372|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503|Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||Percentage of participants||95% Confidence Interval|Number
11373|NCT01984697|Primary|Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 at Four Weeks After the Last Dose of V503|Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 (Month 7 or Month 13)|The per-protocol population included all participants who 1) received all planned vaccinations, 2) had a serum sample collected 4 weeks after the last vaccination, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.||mMU/mL||95% Confidence Interval|Geometric Mean
11374|NCT01984515|Secondary|Patient Health Questionnaire-9 Item|9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.|Referral Management Initiation, 1 month post initiation, 3 months post initiation|||units on a scale||Standard Deviation|Mean
11375|NCT01984515|Secondary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.|Referral Management Initiation, 1 month post initiation, 3 months post initiation|||units on a scale||Standard Deviation|Mean
11376|NCT01984515|Primary|Engagement in Evidence-based Psychotherapy for PTSD|Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.|From initiation of the Referral Management System to 6 months after initiation|||participants|||Number
11377|NCT01984294|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
11378|NCT01984294|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 8 weeks|Full Analysis Set||percentage of participants|||Number
11379|NCT01984294|Secondary|Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set||percentage of participants|||Number
11380|NCT01984294|Primary|Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants were randomized and received at least one dose of study drug.||percentage of participants|||Number
11381|NCT01984294|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study drug.||percentage of participants|||Number
11382|NCT01984229|Secondary|t1/2 of RO5468924: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||hours||Standard Deviation|Mean
11383|NCT01984229|Secondary|t1/2 of RO5468924: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Standard Deviation|Mean
11384|NCT01984229|Secondary|t1/2 of Alectinib: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||hours||Standard Deviation|Mean
11385|NCT01984229|Secondary|Terminal Half-life (t1/2) of Alectinib: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]||hours||Standard Deviation|Mean
11386|NCT01984229|Secondary|Metabolite/Parent Ratio for Cmax: Cohort B|RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||ratio||Standard Deviation|Geometric Mean
12672|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
11387|NCT01984229|Secondary|Metabolite/Parent Ratio for AUC0-inf: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||ratio||Standard Deviation|Geometric Mean
11388|NCT01984229|Secondary|Tmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||hours||Full Range|Median
11389|NCT01984229|Secondary|Tmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]||hours||Full Range|Median
11390|NCT01984229|Secondary|Tmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort B]||hours||Full Range|Median
11391|NCT01984229|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]||hours||Full Range|Median
11392|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
11393|NCT01984229|Secondary|AUClast of RO5468924: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
11394|NCT01984229|Secondary|Cmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||ng/mL||Standard Deviation|Mean
11395|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort A|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
11396|NCT01984229|Secondary|AUClast of RO5468924: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]||h*ng/mL||Standard Deviation|Mean
11397|NCT01984229|Secondary|Cmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]||ng/mL||Standard Deviation|Mean
11398|NCT01984229|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of RO5424802: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
11399|NCT01984229|Primary|AUClast of Alectinib: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]||h*ng/mL||Standard Deviation|Mean
11400|NCT01984229|Primary|Cmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||ng/mL||Standard Deviation|Mean
11401|NCT01984229|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
11402|NCT01984229|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|Pharmacokinetic (PK) Analysis Population [Cohort A] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
11403|NCT01983878|Secondary|PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: Enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.||hours x micrograms/milliliters (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
12673|NCT01953237|Primary|Adherence to Antipsychotic Medications||3 month period|||percentage of days adherent||Standard Deviation|Mean
11404|NCT01983878|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.||micrograms/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
11405|NCT01983878|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Data will not available until study completion at which time the immunogenicity of ramucirumab will be analyzed.|Baseline to 30-Day Follow-up (Up to 42 Weeks)||03/2017||||
11406|NCT01983878|Secondary|Overall Survival (OS)|The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.|Baseline to Death from Any Cause (Up to 13 Months)|FAS: all enrolled participants who received at least one dose of the study drug. 18 participants were censored.||Months||90% Confidence Interval|Median
11407|NCT01983878|Secondary|Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control = (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 12 Months)|FAS: all enrolled participants who received at least one dose of the study drug.||Percentage of Participants||90% Confidence Interval|Number
11408|NCT01983878|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of CR or PR. According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response = (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks)|FAS: all enrolled participants who received at least one dose of the study drug.||Percentage of Participants||90% Confidence Interval|Number
11409|NCT01983878|Secondary|Progression-Free Survival (PFS)|The time from baseline to measured Progressive Disease (PD) as defined by RECIST v.1.1 [defined as > 20% increase from smallest sum of longest diameter recorded since treatment started (best response)], or death due to any cause, whichever is first.|Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks)|FAS: all enrolled participants who received at least one dose of the study drug. 8 participants were censored.||Weeks||90% Confidence Interval|Median
11410|NCT01983878|Primary|Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)|The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.|12 Weeks|Full Analysis Set (FAS): all enrolled participants who received at least one dose of the study drug. 8 participants were censored.||Percentage of Participants||90% Confidence Interval|Number
11411|NCT01983839|Primary|Area Under the Free Concentration-time Curve (fAUC0-24)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of fAUC0-24 for the current study population were reported.~fAUC0-24 were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment|The model estimated median values of fAUC0-24 for the current study population were32.78 mg.hr/L (IQR 22.75; 47.31). respectively.||mg.hr/L||Inter-Quartile Range|Median
11412|NCT01983839|Primary|Total Peak Plasma Concentration (Cmax)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of total Cmax for the current study population were reported.~Each individual model predicted Cmax were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment|||mg/L||Inter-Quartile Range|Median
11413|NCT01983787|Secondary|MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.|MIC to piperacillin/tazobactam was obtained by using E-tests (AB Biodisk, Solna, Sweden) on Mueller-Hinton agar plates incubated at 35 ± 2 degrees Celcius with inoculum, incubation time and atmosphere in accordance to the E-test application guide.|Sputum sample was collected 3 to 7 days before treatment initiation.|||mg/L|||Number
11414|NCT01983787|Secondary|The Time Above the Minimum Inhibitory Concentration (T>MIC)|"The time, expressed in percentage, for which the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%. MIC for the pathogen in sputum was not reported in patient 5. Therefore,T>MIC for this patient could not be estimated.~Patient 1-5 were treated with piperacillin 16g/day. Patient 6-10 were treated with piperacillin 12g/day."|Patients will be followed for the duration of treatment, which is approximately 2 weeks.|||% of time above the MIC|||Number
11454|NCT01981473|Secondary|Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||percentage of participants|||Number
11415|NCT01983787|Primary|Blood-plasma Concentration of Piperacillin|"The free, non-protein bound fraction of plasma piperacillin for each patient was determined using Ultra High Performance Liquid Chromatography. The concentration was compared to the MIC-value (Minimal Inhibitory Concentration) of the pathogen isolated in a sputum sample collected prior to initiation of antibiotic treatment.~Infusion pumps with 16 g of piperacillin per 24 hours were initially used and five patients had piperacillin plasma-concentrations monitored during this treatment regimen. However, in three of these patients, the piperacillin plasma concentrations were unexpectedly low and dropped to a level below the MIC. This was found to be due to antibiotic crystallization within the infusion pumps as a result of the antibiotic concentration being too high. Consequently, infusion pumps with 12 g of piperacillin per 24 hours were used in stead. The median piperaillin concentrations reported below are derived from all measurements within the two weeks of treatment."|Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment|||mg/L||Inter-Quartile Range|Median
11416|NCT01983566|Secondary|AUC(0-inf)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS - Due to premature discontinuation of the study, this endpoint was not evaluated.|||||
11417|NCT01983566|Primary|Cmax|Maximum measured concentration of deleobuvir in plasma (Cmax)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
11418|NCT01983566|Primary|AUC(0-tz)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|Pharmacokinetic set (PKS): included all subjects in the Treated Set who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint that was not affected by important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
11419|NCT01983111|Secondary|Patient Global Impressions of Change(PGIC)|"In the PP set, Number of participants with categorical change in overall satisfaction.~PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse)."|6 weeks|Per protocol set: Analyze the within-group change in the PGIC from Baseline (Week 0) to Week 6 by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.||Scores on 1 to 7point||Standard Deviation|Mean
11420|NCT01983111|Secondary|Clinical Global Impression of Change(CGIC)|The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse.|6 weeks|In the per protocol: Analyze the within-group change in the CGIC from Baseline (Week 0) to Week 6 of the investigational product administration by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.||Scores on 1 to 7 point||Standard Deviation|Mean
11421|NCT01983111|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline and at 6weeks|In the PP set, the change in the your today health score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.||scores on a scale||Standard Deviation|Mean
11422|NCT01983111|Secondary|Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for ‘Motor capability’, ‘Self-care’, ‘Daily activities’, ‘Pain/discomfort’, ‘Depression/anxiety’ and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by “1” means that the healthy condition and high quality of life."|Baseline and at 6 weeks|In the PP set, the change in the quality of life (EQ-5D) total score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.||EQ-5D Total score||Standard Deviation|Mean
11423|NCT01983111|Secondary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline.|2 weeks|In the PP set, the reduction in the pain intensity score from Visit 1 (Baseline) to Week 2 of the investigational product administration was analyzed.||Scores on a scale||Standard Deviation|Mean
11424|NCT01983111|Primary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline.|baseline and 6 weeks|In the PP set, the change in the pain intensity score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.||Scores on a scale||Standard Deviation|Mean
11425|NCT01982812|Secondary|Sequelae|"Neurologic outcome in 3 categories--~Neurologically intact at discharge~Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge~Died during admission, never discharged"|7 days|||participants|||Number
11464|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported therapeutic alliance, measured by the well-validated Working Alliance Inventory (WAI; Horvath & Greenberg, 1989; range 1 to 7, higher score indicated better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||units on a scale||Standard Deviation|Mean
21323|NCT01746511|Primary|Total Number of Hours of Required Phototherapy||from time of enrollment to time of discharge, for a maximum of 10 weeks|||hours||Standard Deviation|Mean
11426|NCT01982812|Secondary|Mean Time From Admission to BCS >/= 4|"The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis.~The Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement~1 - Watches or follows 0 - Fails to watch or follow~Best motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response~Best verbal response 2 - Cries appropriately with pain, or, if verbal, speaks~1 - Moan or abnormal cry with pain 0 - No vocal response to pain"|7 days|Comparing mean time to coma resolution in hours among survivors||hours of coma from admission||Standard Deviation|Mean
11427|NCT01982812|Secondary|Required Additional AED|Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no)|7 days|||Participants requiring additional AEDs|||Number
11428|NCT01982812|Primary|Minutes With Seizure on EEG|Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.|72 hours|||minutes with seizure||Standard Deviation|Mean
11429|NCT01982539|Secondary|Efficacy|To determine efficacy by assessing percent changes of the Numeric Pain Rating Scale (NPRS) pain score from baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.|From Baseline to 1st and 2nd hour||||||
11430|NCT01982539|Primary|To Confirm the Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years|"Safety Endpoints:~Treatment emergent AEs (TEAEs)~Serious adverse events (SAEs)~Withdrawals due to AEs~Deaths~Observed values and changes in vital sign measurements~Observed values and changes in clinical laboratory results~Physical examination findings"|First dose to 30 days after the last dose|The Safety population included all subjects who received at least 1 dose of the study drug.||participants|||Number
11431|NCT01982292|Secondary|Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)|Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion.|48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.||mL/hr/kg||Standard Deviation|Mean
11432|NCT01982292|Secondary|Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours|This analysis was not done due to sparse PK sampling.|48 hours post each infusion|Due to sparse PK sampling, this analysis was not done.|||||
11433|NCT01982292|Secondary|Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)|Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available|pre-infusion and 24, 48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.||ng/ml||Standard Deviation|Mean
11434|NCT01982292|Secondary|Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)|Due to sparse PK sampling, AUC 0-48 hours was not analyzed.|pre-infusion and 8, 24 and 48 hours post each infusion.|Due to sparse PK sampling, this analysis was not done.|||||
11435|NCT01982292|Secondary|Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions|Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain.|16 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.||Participants|||Number
11436|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12)|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.~n = the total number of subjects with evaluable antibody status after specified number of infusions"|At Week 4, Week 8, Week 12|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment||Percentage of participants||90% Confidence Interval|Number
11437|NCT01982292|Secondary|Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12||Week 4, Week 8, Week 12|Safety set:All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment||In international Units||Standard Deviation|Mean
11438|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16|A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period.|Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.||Percentage of patients||90% Confidence Interval|Number
11462|NCT01981473|Secondary|Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).|Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined).|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||percentage of participants|||Number
11439|NCT01982292|Primary|Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.~A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient’s antibody status is considered to be undetermined during the study if it is not defined as positive or negative."|16 weeks|Safety Set: All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment. In this reported analysis, patients with undetermined antibody status are excluded from analysis population||Percentage of participants||90% Confidence Interval|Number
11440|NCT01982253|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|The change between the FPG value collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
11441|NCT01982253|Primary|Change From Baseline in HbA1c at Week 12.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
11442|NCT01981967|Secondary|Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®|Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.|Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set||Participants|||Number
11443|NCT01981967|Primary|Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®||Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set||Participants|||Number
11444|NCT01981967|Primary|Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®||30 minutes post-vaccination up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set||Participants|||Number
11445|NCT01981863|Other Pre-specified|Length of Time Between Incision and Cardiopulmonary Bypass|Mean Length of Time from Incision to Cardiopulmonary Bypass|From incision to bypass, up to 3 hours|||Minutes||Standard Deviation|Mean
11446|NCT01981863|Secondary|Value of Thromboelastography as Monitor of Fibrinolysis|Thromboelastography may display if fibrinolysis is present|6 months|||percentage of clot||Full Range|Median
11447|NCT01981863|Primary|Di-Dimer Increase Before Cardiopulmonary Bypass|Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.|6 months|D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients||ng/mL||Full Range|Median
11448|NCT01981616|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment.~Serious adverse event (SAE) meant any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. Relationship of each AE to study drug was determined by the Investigator."|From the first dose of study medication through Day 127|The Safety Population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on what they actually received.||participants|||Number
11449|NCT01981616|Secondary|Anti-Hepatitis B Surface Antibody Over Time||Baseline and Days 18, 32, 60 and 74|"Per Protocol Population; n indicates the number of participants with available data at each time point."||IU/L||Geometric Coefficient of Variation|Geometric Mean
11450|NCT01981616|Secondary|Percentage of Participants With an Immune Response to Oral Cholera Vaccine|A positive immune response was defined as an increase of greater than 4-fold over the Baseline immunoglobulin M (IgM), IgG, or IgA anticholera antibodies.|Baseline and Day 74|The Dukoral Population was defined as all participants who had evaluable samples for assessing immune response to cholera vaccine (Dukoral) vaccine at any visit.||percentage of participants||95% Confidence Interval|Number
11451|NCT01981616|Primary|Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74|Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.|Day 74|The Per Protocol Population consisted of all participants who received any amount of study drug and who met predefined evaluability criteria, including receiving the correct and complete dose of study drug, completed both Baseline and day 72 serology assessments and full schedule of hepatitis B vaccine and immunomodulator or corticosteroid use.||percentage of participants||95% Confidence Interval|Number
11452|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Trough Drug Concentration.|Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.||Correlation coefficient|||Number
11453|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Efficacy Measures.|Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.||Correlation coefficient|||Number
11455|NCT01981473|Secondary|Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing “no difficulty,” 1 as “some difficulty,” 2 as “much difficulty,” and 3 as “unable to do.” Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst).|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Units on a scale||Standard Deviation|Mean
11456|NCT01981473|Secondary|Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Units on a scale||Standard Deviation|Mean
11457|NCT01981473|Secondary|Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Units on a scale||Standard Deviation|Mean
11458|NCT01981473|Secondary|The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||units on a scale||Standard Deviation|Mean
11459|NCT01981473|Secondary|The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||units on a scale||Standard Deviation|Mean
11460|NCT01981473|Secondary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.|Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Percentage of participants|||Number
11461|NCT01981473|Secondary|Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||µg/mL||Standard Deviation|Mean
11463|NCT01981473|Primary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).|Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.||Percentage of participants|||Number
11465|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported treatment satisfaction, as assessed by the well-validated Client Satisfaction Questionnaire - 8 (CSQ-8; Attkisson & Zwick, 1982; range 0 to 5, higher scores indicate better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||units on a scale||Standard Deviation|Mean
11466|NCT01981356|Secondary|Experimental Treatment Safety|Assessed by the occurrence of zero adverse events attributable to ACT.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.||adverse events|||Number
11467|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient attendance of at least 3 out of 4 sessions on average.|8-month study period|||sessions||Standard Deviation|Mean
11468|NCT01981356|Secondary|Experimental Treatment Feasibility|Assessed by our ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in random assignment to ACT + TAU or TAU.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.||participants|||Number
11469|NCT01981356|Secondary|Barriers and Facilitators to Implementation|We will conduct 30-60 minute semi-structured interviews structured around the RE-AIM framework (Glasgow et al., 1999), and utilizing the RE-AIM Planning Tool (Forman et al., 2010). The RE-AIM framework identifies, for example, barriers that limit patients, staff, and site participation in the intervention and how to address them, and provider and patient perceptions about why the intervention is successful at achieving better outcomes.|8-month study period|Data regarding barriers and facilitators was not obtained from patient participants, but was obtained from study staff, who were not assigned to treatment condition.||Participants providing data|||Number
11470|NCT01981356|Secondary|Cost of Stay|Obtained by: (a) obtaining length obtained by: (a) obtaining length-of-stay (in hours) on the inpatient unit for all study participants, (b) calculating the cost of stay for each participant by multiplying the length-of-stay by the dollar amount associated with inpatient treatment of psychosis (e.g., $1,297/day or $54/hour in 2011; Blow et al., 2011), and (c) summing the cost of stay across participants in each treatment condition.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Data regarding length of stay not available for one participant in each condition, both of whom had not been discharged by the end of the study period.||Dollars||Standard Deviation|Mean
11471|NCT01981356|Secondary|Positive and Negative Affect Scale (Watson et al., 1988)|Assesses short-term changes in global positive and negative affect in addition to changes in specific types of emotions (e.g., afraid, excited, guilty). Positive and negative affect subscales consist of ten items each, averaged to obtain scale scores. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (5) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (5) possible value on scale from baseline to follow-up. Increases in positive affect percentage change and decreases in negative affect change are considered better outcomes.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||percentage of total possible change||Standard Deviation|Mean
11472|NCT01981356|Secondary|Acceptance and Action Questionnaire - II (Bond et al.., 2011)|Assesses changes in the primary mechanism thought to contribute to change in ACT: acceptance. All scale items were averaged to obtain a total scale score. Total scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Increases in percentage change are considered better outcomes (i.e., increased acceptance).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Acceptance and Action Questionnaire - II.||percentage of total possible change||Standard Deviation|Mean
11473|NCT01981356|Secondary|Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)|Assesses changes in the frequency, believability, and associated distress of psychosis symptoms. Frequency, believability, and distress subscales consist of two items each, one assessing delusions and one assessing hallucinations, averaged to obtain subscale scores. Subscale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest to lowest possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest to highest possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced frequency, believability and distress).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Frequency, Believability, and Distress Symptom Scale.||percentage of total possible change||Standard Deviation|Mean
11534|NCT01977729|Secondary|Multidimensional Anxiety Scale for Children|Multidimensional Anxiety Scale for Children (MASC-2; Self-report and Parent completed). Treatment outcome will be assessed on a specific symptom level from the youth's and parent's perspective using the MASC-2. The MASC-2 consists of 50 items across 5 factors: Separation Anxiety/Phobias, Generalized Anxiety Disorder, Social Anxiety, Obsessions & Compulsions, and Harm Avoidance. MASC T-scores less than 65 indicate the child is no longer in the clinical range of anxiety symptoms.|20 weeks from enrollment|Study was terminated before randomization.|||||
12674|NCT01952834|Secondary|Interleukin-12|This is a circulating plasma cytokine|Change before and after 6 weeks of probiotic|Subjects with plasma samples available pre and post probiotic supplementation||pg/mL||Standard Error|Mean
11474|NCT01981356|Primary|Brief Psychiatric Rating Scale (Overall & Gorham, 1962)|Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions). All scale items were averaged to obtain a total scale score. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced symptoms).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|||percentage of total possible change||Standard Deviation|Mean
11475|NCT01981057|Secondary|Osmolarity|"Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11476|NCT01981057|Secondary|Phosphorous|"Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11477|NCT01981057|Secondary|Magnesium|"Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11478|NCT01981057|Secondary|Calcium|"Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11479|NCT01981057|Secondary|Potassium|"Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11480|NCT01981057|Secondary|Sodium|"Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11481|NCT01981057|Secondary|Fat|"Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11482|NCT01981057|Secondary|Carbohydrates|"Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11483|NCT01981057|Secondary|Energy|"Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks||||||
11484|NCT01981057|Primary|Protein|"Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations."|6 weeks|||g/kg/d||Full Range|Median
11485|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.||Participants|||Number
11486|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.||Participants|||Number
11487|NCT01980940|Secondary|Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)|The PGART is a self-administered questionnaire completed by participants. Participant assessment of response of arthritis to study medication was assessed on a 5-point Likert scale ('very well', 'well', 'fair', 'poor', and 'very poor').|Day 2, Day 4, Day 7, Day 11, Day 14, post-trial (up to Day 28)|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Percentage of participants|||Number
11535|NCT01977729|Primary|Clinical Global Impression Severity & Improvement Scales|Youth outcome will be assessed on a global level using the Clinical Global Impression (CGI) Severity Scale, ranging from 1 (not at all) to 7 (among the most extremely ill patients). Higher ratings indicate greater anxiety symptom severity. The CGI Improvement Scale ranges from 1 (very much improved) to 7 (very much worse). Lower ratings indicate greater improvement on anxiety symptom severity. A CGI Improvement Scale rating of 1 or 2 indicates clinically meaningful improvements in anxiety symptom severity.|20 weeks from enrollment|Medication was never given, and tests were never done.|||||
11488|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale|The WOMAC VA 3.1 Physical Functioning subscale is a self-administered questionnaire assessing lower extremity physical function due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Physical Functioning subscale had 17 questions with answers to each item assessed on a 100 mm VA scale (0 = no difficulty; 100 = extreme difficulty). The score for each item was summed and the overall score ranged from 0 to 1700 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in physical function.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Units on a scale||Standard Deviation|Mean
11489|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale|The WOMAC VA 3.1 Stiffness subscale is a self-administered questionnaire assessing lower extremity stiffness due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Stiffness subscale had two questions with answers to each item assessed on a 100 mm VA scale (0 = no stiffness; 100 = extreme stiffness). The score for each item was summed and the overall score ranged from 0 to 200 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in stiffness.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Units on a scale||Standard Deviation|Mean
11490|NCT01980940|Primary|Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale|The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|Full analysis set (FAS) defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment||Units on a scale||Standard Deviation|Mean
11491|NCT01980940|Primary|Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing|Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (AUC0-last) without any protocol violation that interferes with PK data interpretation||mg||90% Confidence Interval|Least Squares Mean
11492|NCT01980940|Primary|Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing|Tmax determined for the period up to 72 hours post-single application.|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Tmax) without any protocol violation that interferes with PK data interpretation||hour||Full Range|Median
11493|NCT01980940|Primary|Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing|Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Cmax) without any protocol violation that interferes with PK data interpretation||mg||90% Confidence Interval|Least Squares Mean
11494|NCT01980628|Secondary|DOR (Duration of Response)|The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.|Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months.|||Months||95% Confidence Interval|Median
11495|NCT01980628|Primary|ORR (Overall Response Rate)|ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review comittee (IRC).|Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months.|||Percentage of Responders||95% Confidence Interval|Mean
11496|NCT01980589|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:~Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal."|From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.|Safety population||participants|||Number
11497|NCT01980589|Secondary|Time To Response (TTR)|Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Participants with an overall response||months||Full Range|Median
11498|NCT01980589|Secondary|Overall Response Rate (ORR)|Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Safety population||percentage of participants||95% Confidence Interval|Number
11499|NCT01980589|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.~Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:~Nonhematologic:~≥ Grade 3 non-hematological toxicity~≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours~Hematologic:~Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days~Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration~Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment~Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding"|First cycle treatment over 28-days|The Safety population is defined as all enrolled participants who received any study treatment.||participants|||Number
11500|NCT01980095|Other Pre-specified|H. Pylori Eradication|The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment|28-56 days after completion of SOC treatment|||Participants|||Count of Participants
11501|NCT01980095|Primary|The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing|Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.|28-56 days after completion of treatment|||Participants|||Count of Participants
11502|NCT01979185|Primary|Maximum Plasma Concentration (Cmax) of Simvastatin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
11503|NCT01979185|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/ml||Standard Deviation|Mean
11504|NCT01979185|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/ml||Standard Deviation|Mean
11505|NCT01979029|Other Pre-specified|Systemic Blood Pressure||after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon|||mmHg||Standard Deviation|Mean
11506|NCT01979029|Secondary|Distal Colon Length||after digestive tract reconstruction|||cm||Standard Deviation|Mean
11507|NCT01979029|Primary|The Blood Pressure of the Arterial Arcade||after ligating the inferior mesentric artery or superior rectal artery|||mmHg||Standard Deviation|Mean
11508|NCT01978600|Secondary|Mean 24-hour IOP at Week 4|24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
11509|NCT01978600|Secondary|Mean Diurnal IOP at Week 4|Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
11510|NCT01978600|Primary|Mean Nocturnal IOP at Week 4|Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
11511|NCT01978145|Secondary|Change From Baseline in COPD Assessment Test (CAT) Scores at Week 12|The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items, each formatted on a semantic differential scale. Participants rated their experience on a 6-point scale for each question, ranging from 0 to 5 with a maximum total score of 40. Higher scores indicate greater disease impact. CAT of each participant was assessed at Baseline (Day 1) and Week 12 (Day 85) of each treatment period. Change from Baseline within each period was calculated as values at Week 12 minus period specific Baseline value. The change from Baseline in CAT overall score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline CAT overall score, adjusted treatment period specific Baseline CAT overall score, treatment group, treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
11512|NCT01978145|Secondary|Change From Baseline in St George’s Respiratory Questionnaire-COPD (SGRQ C) Score at Week 12|The SGRQ-C is a 40-item COPD-specific questionnaire designed to measure the effect of COPD and its treatment on the participant’s health-related quality of life (HRQoL). The SGRQ-C includes 14 questions with a total of 40 items grouped into three components (symptoms, activity, and impacts). Each questionnaire response has a unique empirically derived weight. The lowest possible weight is zero and the highest is 100. Higher scores indicate greater impairment of HRQoL. HRQoL of participants was assessed using the SGRQ-C at Baseline (Day 1) and Week 12 of each treatment period. Change from Baseline was calculated as value at Week 12 minus the period specific Baseline value. Change from Baseline in SGRQ total score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline SGRQ total score, adjusted treatment period-specific Baseline SGRQ total score, treatment group, and treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
11513|NCT01978145|Secondary|Change From Baseline in Transition Dyspnoea Index (TDI) Focal Score at Days 28, 56 and 85|Baseline Dysponea Index (BDI) and Transition Dyspnoea Index (TDI) are interview-based measurements of breathlessness due to COPD related daily living activities. Scores depend on ratings for 3 categories: functional impairment, magnitude of task and magnitude of effort. BDI was collected at Day 1 and TDI at Days 28, 56 and 85 of each treatment (trt) period. Each BDI scale has 5 possible scores ranging from 0 to 4, with 0 (worst) to 12 (best) as the total range. Each TDI scale has 7 possible scores ranging from -3 to +3, with -9 (worst) to +9 (best) as the total range. TDI focal score >=1 is considered to be a clinically meaningful change. Change from Baseline was calculated as TDI minus BDI values. Analysis was performed using MMRM by par. level BDI focal score, adjusted period-specific BDI focal score, trt group, trt period, visit, visit*trt group, visit*par. level BDI focal score, visit*adjusted period-specific BDI focal score as a fixed effect and with par. as a random effect.|Baseline, and Days 28, 56 and 85|ITT population. Only those participants available at the specified time points were analyzed (n=X, X in the category title).||Scores on a scale||Standard Error|Least Squares Mean
11514|NCT01978145|Secondary|FEV1 Area Under the Curve From 0 to 10 Hours (AUC [0-10]) on Day 85 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1. The FEV1 was measured on Day 85 of each treatment period at time 0 (predose),15 minutes, 30 minutes, 1, 2, 4, 6, and 10 hours post morning dosing for determination of AUC 0 to10 hours. The AUC was analyzed using a mixed effects analysis of covariance (ANCOVA) with participant-level Baseline (Day 1 trough FEV1), adjusted period-specific Baseline (Day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.||Liter*hours||Standard Error|Least Squares Mean
11515|NCT01978145|Secondary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 28 and 56|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 at Days 28 and 56 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Days 27 and 55). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Days 28 and 56 of each treatment period|Intent-to-Treat (ITT) Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Liters (L)||Standard Error|Least Squares Mean
11516|NCT01978145|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Day 85 of each treatment period|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomized study treatment in the treatment period. Only those participants available at the specified time points were analyzed.||Liters (L)||Standard Error|Least Squares Mean
11591|NCT01976988|Secondary|Number of Participants With Postoperative Thrombocytopenia|Thrombocytopenia defined as >50% or greater drop in platelet count|30 day postop period|||participants|||Number
11517|NCT01978119|Secondary|Change From Baseline in the Percentage (%) of Rescue-free Days Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|A rescue-free day is defined as a 24-hour period with no rescue medication usage recorded (i.e. both the day-time and night-time numbers of puffs of Salbutamol/Albuterol are zero). Percentage of Rescue-Free Days was calculated over each 12-week Treatment Period, dividing the number of rescue-free days by the length of the TP. The BL value of change from BL in % rescue free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from BL was the difference over 12 weeks for each treatment period compared to BL. The change from BL in the % of rescue medication-free days averaged over the 12-week TP was analyzed, using mixed effects ANCOVA model, with par level BL % of rescue-free days, adjusted period-specific BL % of rescue-free days treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Percentage of rescue-free days||Standard Error|Least Squares Mean
11518|NCT01978119|Secondary|Change From Baseline in Asthma Control Test (ACT) Over 12 Weeks for Each Treatment Period|The ACT is a 5-item questionnaire with a score of 1 to 5 for each item (1=poor control and 5=good control). The scores from each question were added to give an overall score. Baseline was defined as the value obtained predose (0 minutes) on day 1 of each Treatment Period. Change from Baseline was the difference in ACT score at the timepoint compared to Baseline score. The change from Baseline in overall ACT score was analysed, using mixed effects ANCOVA model, with participant level Baseline overall ACT score, adjusted period-specific Baseline overall ACT score, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Scores on the scale||Standard Error|Least Squares Mean
11519|NCT01978119|Secondary|Change From Baseline in the Percentage of Symptom-Free Days From Paper Diary Card Over 12 Weeks|A Symptom-Free day was defined as a 24-hour period with no symptoms recorded. Percentage of Symptom-Free Days was calculated dividing number of Symptom-Free days by the length of the Treatment Period. The baseline value of change from baseline in % of symptom free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from Baseline was the difference in percentage of Symptom-Free days at week 12 compared to Baseline. The change from Baseline in the percentage of Symptom-Free days averaged over the 12-week Treatment Period was analyzed, using mixed effects ANCOVA model, with participant level Baseline percentage of Symptom-Free days, adjusted period-specific Baseline percentage of Symptom-Free days, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Percentage of symptom-free days||Standard Error|Least Squares Mean
11520|NCT01978119|Secondary|Change From Baseline in Day-time(AM) and Night-time (PM) Asthma Symptoms(Sy) From Paper Diary Card (PDC) Over 12 Weeks(wk) for Each Treatment Period(TP)|AM Sy scores were recorded nightly on PDC using the scale:0=No Sy during day,1=Sy for one short period during day,2=Sy for two or more short periods during day,3=Sy for most of day-not affecting normal daily activities,4=Sy for most of day-did affect normal daily activities,5=Sy so severe-could not go to work or perform normal daily activities. Similarly, PM Sy scores were recorded every morning using the scale:0=No Sy during night,1=Sy causing me to wake once(or early),2=Sy causing me to wake twice or more(or early),3=Sy causing me to be awake most of night,4=Sy severe-did not sleep. BL= average of last 4 available of the last 7 days of Screening Period(TP 1) and of Washout Period(TP 2). Change from BL in average of daily scores=difference over 12 wks for each TP compared to BL. AM and PM Sy Scores were separately averaged over each of the two 12-wk TP. Total value of each endpoint over 12-wk TP was divided by number of days with non-missing data to obtain an average for each subject|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.||Scores on the scale||Standard Deviation|Mean
11521|NCT01978119|Secondary|Change From Baseline (BL) in Rescue Medication Use Over 12 Weeks (From Paper Diary Card) for Each Treatment Period (TP)|Rescue medication usage for each 24-hour period is defined as the total numbers of puffs of Salbutamol/Albuterol within 24 hours (i.e. number taken during the day and number taken during the night). The total usage over the 12 week TP was divided by the number of days with nonmissing rescue medication data to get an average usage per participant. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). Change from BL in average usage of rescue medication was the difference over 12 weeks for each TP compared to BL. The change from BL in the percentage of rescue medication use averaged over the 12-week TP was analysed using mixed effects ANCOVA model, with par level BL rescue medication use, adjusted period-specific BL rescue medication use, treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Puffs per day||Standard Error|Least Squares Mean
11522|NCT01978119|Secondary|Change From Baseline (BL) in Morning Peak Expiratory Flow Rate (PEFR) Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|The PEFR is a paricipant’s(par) maximum speed of expiration, as measured with a peak flow meter(PFM). All par were issued a PFM and instructed to perform the activity in triplicate in the morning prior to taking the bronchodilator. The best among the 3 readings was selected. Efficacy measurement was recorded by the par in the paper Diary Card for morning PEFR. The total PEFR over the 12 week TP was divided by the number of days with non-missing PEFR data to obtain an average for each par. Change from BL in average morning PEFR is the difference over 12 weeks for each TP compared to BL. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). The change from BL in the PEFR averaged over the 12-week TP was analysed using a mixed effects ANCOVA model with participant level BL PEFR, adjusted period-specific BL PEFR, treatment group, and period as fixed effects, and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed||Liters per minute||Standard Error|Least Squares Mean
12675|NCT01952834|Secondary|Interleukin 8|Circulating cytokine measured in the plasma|Change before and after 6 weeks of daily Probiotic|||pg/mL||Standard Error|Mean
11523|NCT01978119|Secondary|Change From Baseline in Morning Trough FEV1 at Day 28 and Day 56|Pulmonary function was measured by FEV1, a measure of lung function, and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry at predose (Baseline), on Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on Day 1of each Treatment Period. Change from Baseline within each period was calculated as trough FEV1 at Day 28 and 56 minus the period specific Baseline value.The change from Baseline in trough FEV1 at Day 28 and Day 56 was analysed via the primary analysis model. Least Squares mean values for the change from Baseline in trough FEV1 at Day 28 and Day 56 were obtained from the primary analysis model (for each treatment and for the treatment difference), and displayed alongside corresponding 95% confidence intervals.|Baseline, Day 28, and Day 56|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.||Liter||Standard Error|Least Squares Mean
11524|NCT01978119|Secondary|FEV1 AUC (0-12) at Day 85 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.||Liter*hours||Standard Error|Least Squares Mean
11525|NCT01978119|Secondary|FEV1 Area Under the Curve From 0 to 12 Hours (AUC [0-12]) on Day 1 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 1 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.||Liter*hours||Standard Error|Least Squares Mean
11526|NCT01978119|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analysed using Mixed Model for Repeated Measures analysis, having fixed effect Participant level Baseline, Adjusted period-specific Baseline, Treatment group, Period, Visit, Visit by treatment, Visit by Participant level Baseline, Visit by Adjusted period-specific Baseline, with participant as a random effect.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomised study treatment in the Treatment Period. Only those participants available at the specified time points were analyzed.||Liter||Standard Error|Least Squares Mean
11527|NCT01977820|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Death and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 24 weeks + 4-week follow-up|The safety analysis population included all the randomized subjects who received at least one dose of study treatment.||Subjects|||Number
11528|NCT01977794|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs was AEs that started or worsened in severity on or after the date of first dose of IMP until the end of the study. AEs leading to death and discontinued were also presented.|Baseline up to Day 127 (end of trial)|Safety analysis set included all subjects who received at least 1 dose of IMP.||subjects|||Number
11529|NCT01977794|Secondary|Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment|Baseline was defined as the latest HR before study treatment administration|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.||beats per minute||Standard Deviation|Mean
11530|NCT01977794|Secondary|Percentage of Subjects With Controlled Blood Pressure||Baseline up to Week 18|MITT analysis set included all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP.||percentage of subjects|||Number
11531|NCT01977794|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment|Baseline was defined as the latest DBP before study treatment administration.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.||mmHg||Standard Deviation|Mean
11532|NCT01977794|Primary|Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline|Baseline was defined as the latest SBP under monotherapy.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.||millimeters of mercury (mmHg)||Standard Deviation|Mean
11533|NCT01977729|Other Pre-specified|Positive and Negative Affect Scale for Children|Positive and Negative Affect Scale for Children (PANAS-C). Negative affect (NA) will be assessed using the NA subscale on the PANAS-C. The 15 NA items (e.g., sad, miserable) on the 27-item PANAS-C are scored 1 (very slightly or not at all) to 5 (extremely). Higher scores in the NA subscale indicate higher levels of negative affect.|20 weeks from enrollment|No data collected.|||||
11536|NCT01977573|Secondary|Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit|Number of Weeks dose was withheld because hemoglobin exceed the upper limit is presented as the number of participants with withheld dose during the time periods categorized by Weeks.|From Week 4 up to Week 24|ITT population.||participants|||Number
11537|NCT01977573|Secondary|Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline|Participants receiving additional therapies of blood transfusions, intravenous (IV) iron or rhEPO any time Post Baseline were analyzed. RhEPO was not applicable for the control arms since it was a planned therapy in those arms, hence presented as NA. (EudraCT only: A value of 99999 is used where no data is available or NA.)|From Day 1 up to Week 28|ITT Population||participants|||Number
11538|NCT01977573|Secondary|Number of Participants With at Least One Dose Cycle up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.||participants|||Number
11539|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. A Hgb cycle is two consecutive Hgb excursions in different directions.|Up to 24 weeks|Completers population.||participants|||Number
11540|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks.|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 weeks|Completers population.||participants|||Number
11541|NCT01977573|Secondary|Number of Dose Cycles up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease).|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.||number|||Number
11542|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Cycles up to 24 Weeks|A Hgb cycle is calculated as two consecutive Hgb excursions in different directions. A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 Weeks|Completers population. Only participants with Hgb cycles were analyzed.||number of Hgb cycles|||Number
11543|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Excursions|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. Hgb cycle is calculated as two consecutive Hgb excursions in different directions.|Up to 24 Weeks.|Completers Population: ITT participants who fully completed study without prematurely discontinuing study drug. Only participants with Hgb excursions were analyzed.||number of excursions|||Number
11544|NCT01977573|Secondary|Mean Final Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.||milligrams per day||Standard Deviation|Mean
11545|NCT01977573|Secondary|Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.||milligrams||Standard Deviation|Mean
11546|NCT01977573|Secondary|Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. The number of participants with an adjustment are presented at the timings at which adjustments were done.|From Week 4 up to Week 20|ITT population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.||Participants|||Number
11547|NCT01977573|Secondary|Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. Frequency is presented as the number of participants with dose adjustment(s) once, twice, thrice, four times, or five times.|From week 4 up to 24 weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.||participants|||Number
11548|NCT01977573|Secondary|Mean Number of Dose Adjustments up to 24 Weeks|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system.|From Week 4 up to 24 Weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.||number of adjustments||Standard Deviation|Mean
11549|NCT01977573|Secondary|Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint|Blood samples were collected for individual plasma GSK1278863 and metabolite (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, and GSK2531403) concentration measurement on Day 1 (pre-dose), Wk 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose). Participants available in each arm at the specified time points have been presented.|Day 1 (pre-dose), Week (Wk) 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose)|Pharmacokinetics (PK) population: All participants from whom a PK sample was obtained and analyzed. This population did not include participants from the control groups.||nanograms per milliliter||Standard Deviation|Mean
11605|NCT01976806|Other Pre-specified|Serum Fasting Lipid Profile|Baseline and follow-up fasting lipid profiles were measured for descriptive purposes of our study population.|Baseline and 3 months||||||
11550|NCT01977573|Secondary|Change From Baseline in Reticulocyte Cell Count at Week 24|Reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline is the last pre-dose red reticulocyte count. Change from Baseline in reticulocyte cell count was calculated by subtracting the Baseline count from the Week 24 count.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||percentage of reticulocytes||Standard Deviation|Mean
11551|NCT01977573|Secondary|Change From Baseline in Red Blood Cell Count at Week 24|Baseline is the last pre-dose red blood cell count. Change from Baseline in red blood cell count was calculated by subtracting the Baseline count from the post-dose count.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||10^12 cells per liter||Standard Deviation|Mean
11552|NCT01977573|Secondary|Change From Baseline in Hematocrit at Week 24|Baseline is the last pre-dose hematocrit value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||percentage change in Fraction of 1||Standard Deviation|Mean
11553|NCT01977573|Secondary|Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24|Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||picogram||Standard Deviation|Mean
11554|NCT01977573|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24|TIBC measures the blood's capacity to bind iron with transferrin. Baseline is the last pre-dose TIBC value. Change from Baseline in TIBC was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||micromoles per liter||Standard Deviation|Mean
11555|NCT01977573|Secondary|Change From Baseline in Total Iron at Week 24|Baseline is the last pre-dose total iron value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with available total iron values at Baseline and Week 24 were analyzed.||micromoles per liter||Standard Deviation|Mean
11556|NCT01977573|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||percent change||95% Confidence Interval|Geometric Mean
11557|NCT01977573|Secondary|Change From Baseline in Transferrin Concentration at Week 24|Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||grams per liter||Standard Deviation|Mean
11558|NCT01977573|Secondary|Change From Baseline in Ferritin Concentration at Week 24|Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.||micrograms per liter||Standard Deviation|Mean
11559|NCT01977573|Secondary|Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24|The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Weeks 12 to 24|ITT population. Only participants with data available at specific time points were analyzed.||percentage of days||Standard Deviation|Mean
11560|NCT01977573|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-baseline values minus the Baseline value.|Baseline and up to Week 24|ITT population. Only participants with data available at Baseline and a maximum observed change were analyzed.||percent change in VEGF concentration||95% Confidence Interval|Geometric Mean
11561|NCT01977573|Secondary|Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)|Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baseline values minus the Baseline value.|Baseline to Week 24|ITT population. Only participants having a Baseline EPO measurement and at least one post-baseline EPO measurement were analyzed.||International Units per liter||Standard Deviation|Mean
11606|NCT01976806|Other Pre-specified|Vital Signs|Baseline and follow-up vital signs, including temperature, blood pressure, heart rate were measured to assess for safety and eligibility (uncontrolled hypertensives were excluded).|Baseline and 3 months||||||
11607|NCT01976806|Other Pre-specified|Change in Red Blood Cell Membrane Docosahexaenoic Acid|Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.|Baseline and 3 months||||||
11562|NCT01977573|Secondary|Percent Change From Baseline in Hepcidin Concentration at Week 24|Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|Intent-to-Treat (ITT) population consisted all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants with available hepcidin values at Baseline and Week 24 were analyzed.||percent change in Hepcidin||95% Confidence Interval|Geometric Mean
11563|NCT01977573|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The Hgb stopping criteria was a value of <7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure.|Over a period of 24 Weeks|ITT population.||Participants|||Number
11564|NCT01977573|Secondary|Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24|Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Week 24|ITT population. Only participants who were available at the indicated time point were analyzed.||participants|||Number
11565|NCT01977573|Primary|Summary of Hemoglobin (Hgb) Concentration at Week 24|"The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original criteria (Original) and those following the amended (Amended) criteria. The primary objective was to characterize the ability of GSK1278863 to achieve mean Hgb response within the target range."|Week 24|Intent-to-Treat (ITT): The ITT population consisted of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants who were available at the indicated time point were analyzed.||grams per deciliter||Standard Deviation|Mean
11566|NCT01977482|Secondary|Change From Baseline in Reticulocyte Count at Week 24|A reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline value for reticulocyte count is the pre-dose value on Day 1. Change from Baseline in reticulocyte count was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Percentage of reticulocytes in blood||Standard Deviation|Mean
11567|NCT01977482|Secondary|Change From Baseline in Red Blood Cells at Week 24|Baseline value for red blood cells is the pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||10^12 cells/Liter||Standard Deviation|Mean
11568|NCT01977482|Secondary|Change From Baseline in Hematocrit at Week 24|Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Fraction of 1||Standard Deviation|Mean
11569|NCT01977482|Secondary|Change From Baseline in Reticulocyte Hemoglobin at Week 24|Baseline value for reticulocyte hemoglobin is the pre-dose value on Day 1. Change from Baseline in reticulocyte hemoglobin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Picogram||Standard Deviation|Mean
11570|NCT01977482|Secondary|Change From Baseline in Total Iron Binding Capacity at Week 24|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Micromoles/Liter||Standard Deviation|Mean
11571|NCT01977482|Secondary|Change From Baseline in Total Iron at Week 24|Baseline value for total iron is the pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Micromoles/Liter||Standard Deviation|Mean
11572|NCT01977482|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline =: 100*(exp(Mean change log scale)-1).|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Percent change||95% Confidence Interval|Geometric Mean
11573|NCT01977482|Secondary|Change From Baseline in Transferrin at Week 24|Baseline value for transferrin is the pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||grams (g)/Liter (L)||Standard Deviation|Mean
11574|NCT01977482|Secondary|Change From Baseline in Ferritin at Week 24|Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Micrograms/Liter||Standard Deviation|Mean
11575|NCT01977482|Secondary|Percent Change From Baseline in Hepcidin at Week 24|Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Percent change||95% Confidence Interval|Geometric Mean
11608|NCT01976806|Secondary|Urine N-Terminal Telopeptides|Urine N-Terminal Telopeptides are a measure of systemic bone turnover.|Baseline and 3 months||||||
11576|NCT01977482|Secondary|Population Plasma PK Parameters of GSK1278863 and Metabolites|Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose [PrD), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour [hr] post-dose [PoD), and at W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.|Day 1, Week 4, and Week 20|Pharmacokinetic Population. Only participants with data available at specific time point were analyzed.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
11577|NCT01977482|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline to Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Percent change||95% Confidence Interval|Geometric Mean
11578|NCT01977482|Secondary|Maximum Observed Change From Baseline in Erythropoietin (EPO)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-dose values minus the Baseline value.|Baseline to Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||international units(IU)/Liter (L)||Standard Deviation|Mean
11579|NCT01977482|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The number of participants who reached the Hgb stopping criteria of Hgb concentration <7.5 g/dL were presented.|Up to 24 weeks|ITT Population||Participants|||Number
11580|NCT01977482|Secondary|Number of Participants With Hgb in the Target Range at Week 24|The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||Participants|||Number
11581|NCT01977482|Secondary|Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24|The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated.|Week 20 to Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.||Percentage of days||Standard Deviation|Mean
11582|NCT01977482|Secondary|Hgb Concentration at Week 24|Hgb values measured at Week 24 are presented.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.||g/dL||Standard Deviation|Mean
11583|NCT01977482|Primary|Change From Baseline in Hemoglobin (Hgb) at Week 4|Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Alpha is the coefficient of the model covariate for centred Baseline.|Baseline (Week -4, Week-2 and Day 1) and Week 4|ITT Population. Only participants with data available at specific time point were analyzed.||grams (g)/deciliter (dL)||Standard Deviation|Mean
11584|NCT01977456|Other Pre-specified|The Number of Participants With Good Outcomes According to the Modified Rankin Score.|Modified Rankin score (mRS) dichotomized to good outcome (mRS 0-1 or return to baseline), poor outcome (all others including death). Results reported are good outcome.|90 days from the date of stroke onset|||participants|||Number
11585|NCT01977456|Secondary|The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2).|Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT|within 36 hours after stroke onset|||participants|||Number
11586|NCT01977456|Secondary|The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH).|Any ICH symptomatic (as defined above) or asymptomatic (that visualized on CT or MRI only)|within 36 hours after stroke onset|||participants|||Number
11587|NCT01977456|Primary|The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH).|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|within 36 hours after stroke onset|||participants|||Number
11588|NCT01976988|Secondary|Number of Participants With VTE Within 30-day After Surgery|any VTE occuring within 30-days after surgery - clinical or asymptomatic - detected by venous duplex ultrasound, vq scan or ct pulmonary angiogram.|30 day postop period|||participants|||Number
11589|NCT01976988|Secondary|Hospital Stay|Length of postoperative hospital stay|30 day postop period|||days||Inter-Quartile Range|Median
11590|NCT01976988|Secondary|Number of Participants With Surgical Complications|Major or minor medical and surgical complications|30 day postop period|||participants|||Number
11592|NCT01976988|Secondary|Number of Participants With Bleeding Complications|"Major bleeding defined as any intracranial or intraocular hemorrhage or bleeding from any site associated with >2g/dL drop in hemoglobin or transfusion of >2 unit packed RBCs (including operative site bleeding, unexpected upper or lower gastrointestinal hemorrhage, or retroperitoneal hemorrhage) or any hemorrhage needing surgical intervention/reoperation or leading to death.~Minor bleeding defined as wound hematoma, ecchymosis >10 cm, epistaxis of more than 2 minute duration, macroscopic hematuria, unexpected upper or lower GI hemorrhage associated with <2g/dL drop in hemoglobin or <2 unit packed RBC transfusion"|30 day postop period|||participants|||Number
11593|NCT01976988|Primary|Number of Participants With Postoperative VTE Within 48 Hours After Surgery|Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period|48 hour postop period|||participants|||Number
11594|NCT01976871|Secondary|The Clinician Global Impression of Change Scale|The Clinician Global Impression of Change scale (CGIC) will be used to assess patient satisfaction with treatment.|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||participants|||Number
11595|NCT01976871|Secondary|The Patient Global Impression of Change Scale|"The Patient Global Impression of Change scale (PGIC) will be used to assess patient satisfaction with treatment.~The PGIC assesses subjective changes in symptoms during clinical trials. This single-item scale asks participants to rate their symptoms as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.” The measure provides a responsive and easily interpretable assessment of participants’ evaluations of the importance of their improvement or worsening."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||participants|||Number
11596|NCT01976871|Secondary|Preference of Medication Scale (POM)|"The POM will be used to assess patient satisfaction with treatment.~The POM scale is designed to summarize subjects’ preference for the study medication compared to prior therapy. It asks a single question: How does this current medicine compare to the previous RLS medicine(s) you were taking? The response set is as follows: (1) Much Better, I prefer this medication (indicating preference for rotigotine); (2) Slightly Better; (3) About the Same; (4) Slightly Worse; (5) Much Worse, I much prefer my previous medication (indicating preference for oral dopamine agonist)."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||participants|||Number
11597|NCT01976871|Secondary|RLS-6 Scale|"The RLS-6 scale will be used to determine the overall efficacy of RLS symptom control on rotigotine, calculated as a mean score for each scale during the final treatment week vs baseline.~The RLS-6 scale are 11-point (0=not present to 10=very severe) metrics for measuring RLS severity. Four questions delineate a severity profile of RLS during different night and daytime periods: at bedtime, during the night, during the day at rest, during daily activities. The final two questions assess satisfaction with sleep and severity of sleepiness during the day. The RLS-6 scales have been validated on a day-to-day basis, with relatively low placebo effect compared to other RLS rating scales.~Minimum score 0, maximum score 60. A decrease in the RLS-6 score indicates a better outcome. The RLS-6 scale was completed each day of the study and averaged for the baseline week (approximately days 1-7 of the study) and the final week (approximately days 21-28 of the maintenance period)."|Average of Baseline titration week (approximately days 1-7 of the study) vs. Average of Final Treatment week (integrating data from days 28-35 after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||units on a scale||Standard Deviation|Mean
11598|NCT01976871|Secondary|International Restless Legs Scale (IRLS)|"The IRLS will be used to determine the overall efficacy of RLS symptom control on rotigotine.~The IRLS is a well-validated instrument for measuring RLS severity during the past week. It includes 10 questions encompassing intensity and frequency of symptoms, associated sleep problems, and the impact of symptoms on the patients’ mood and daily functioning. This scale has been shown to have high internal consistency, inter-examiner reliability, test-retest reliability, and convergent validity.~Minimum score 0, maximum score 40. A decrease in the IRLS score indicates a better outcome."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)|||units on a scale||Standard Deviation|Mean
11599|NCT01976871|Primary|Proportion of Patients Completing the Switch and Their Adverse Events|"The primary endpoint will be the safety and tolerability of switching from an oral dopamine agonist to rotigotine.~The CGIC scales were developed to assess treatment outcomes in pharmacological studies. The scales are meant completed by the clinician in person after assessment of the subject. They include 4 global scales describing the severity of illness, change in severity from baseline, therapeutic efficacy, and tolerability of treatment.~Clinical Global Impression - Improvement scale (CGI-I) rated as: 1, very much improved since the baseline week; 2, much improved; 3, minimally improved; 4, no change from baseline; 5, minimally worse; 6, much worse; or 7, very much worse since the baseline week. The CGI-I was performed at baseline and at Week 5 to see which participants rated as much or very much improved.~Adverse Events are reported in the Adverse Events module."|Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits|||participants|||Number
11600|NCT01976845|Secondary|Produces Amnesia(Memory Recall)|"Ability to recall (memory of):~•recall of 2 pictures"|one day|Subjects who recall the picture||participants|||Number
11601|NCT01976845|Secondary|Scores on the Verbal Rating Scale For Sleepiness (Sedation)|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely sleepiness)|one day|||Scores on a Scale (0-10)||Standard Deviation|Mean
11602|NCT01976845|Primary|Scores on the Verbal Rating Scale For Anxiety|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely nervous)|one day|||Scores on a Scale (0-10)||Standard Deviation|Mean
11603|NCT01976806|Other Pre-specified|Urine Beta-human Chorionic Gonadotropin|Urine beta-human chorionic gonadotropin was measured in all female subjects for eligibility (pregnant females excluded for safety).|Baseline||||||
11604|NCT01976806|Other Pre-specified|Serum Complete Blood Count|Baseline and 3 month follow-up complete blood counts were measured for descriptive purposes of our study population and for safety.|Baseline and 3 months||||||
11609|NCT01976806|Secondary|Serum Soluble Vascular Cell Adhesion Molecule|Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.|Baseline and 3 months||||||
11616|NCT01976806|Secondary|Change in Plaque Index (0-3)|"Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line.~Score Criteria:~0: No plaque~A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe.~Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.~Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|Baseline and 3 months||||||
11617|NCT01976806|Secondary|Change in Gingival Index (0-3)|"Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3).~Score Criteria:~0: No inflammation.~Mild inflammation, slight change in color, slight edema, no bleeding on probing.~Moderate inflammation, moderate glazing, redness, bleeding on probing.~Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding."|Baseline and 3 months||||||
11618|NCT01976806|Primary|Change in Pocket Depth (mm)|Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).|Baseline and 3 months|||mm||Standard Error|Mean
11619|NCT01976650|Secondary|Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved and was considered 'effective'. The percentage of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|4 Years|Efficacy Population: all patients who were treated per protocol who had data available for analysis||Percentage of Participants|||Number
11620|NCT01976650|Primary|Number of Patients With Adverse Events or Adverse Drug Reactions|An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|4 Years|Safety Population: all patients who were treated per protocol and completed a survey||Patients|||Number
11621|NCT01976624|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.|Baseline, Week 4|Efficacy population included all participants who were treated for on-label indications with data available for analysis.||mmHg||Standard Deviation|Mean
11622|NCT01976624|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|Up to 51 months|Safety population included all participants treated for on-label indications.||participants|||Number
11623|NCT01976572|Secondary|t1/2||From pre-dose to 48 hours post-dose||||||
11624|NCT01976572|Secondary|Tmax||From pre-dose to 48 hours post-dose||||||
11625|NCT01976572|Primary|Cmax of Candesartan|Maximum observed plasma concentration|From pre-dpse to 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.||ng/mL||Standard Deviation|Mean
11626|NCT01976572|Primary|AUC0-t of Candesartan|Area under the plasma concentration-time curve from time zero up to the last quantifiable time-poin|From pre-dpse to 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.||ng.h/mL||Standard Deviation|Mean
11627|NCT01976299|Secondary|Secondary Endpoint 3|Change in kidney function.|3-5 days|||Change in eGFR (mL/min/1.73m²)||Standard Deviation|Mean
11628|NCT01976299|Secondary|Secondary Endpoint 2|Comparing event rates of major adverse events.|30 Days|||events|||Number
11629|NCT01976299|Secondary|Secondary Endpoint 1|Reduction in volume contrast media required|30 Days|Reduction in volume of contrast was analysed in an interim analysis once half the patient population was enrolled.||Contrast Volume (ml)||Standard Deviation|Mean
11630|NCT01976299|Primary|Primary Safety Endpoint|Incidence of device related serious adverse events|30 days|||Participants|||Count of Participants
11631|NCT01976299|Primary|Primary Effectiveness Endpoint|Reduction in the incidence of Contrast Induced Nephropathy (CIN)|3-5 days|||Participants|||Count of Participants
11632|NCT01975974|Primary|Successful First Attempt Peripheral Venous Cannulation|we will compare the first attempt success rate using proposed ultrasound technique with existing published data|one day|||participants|||Number
11633|NCT01975675|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
11634|NCT01975675|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
11635|NCT01975675|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
11636|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
12749|NCT01952366|Primary|Depression|Relapse/recurrence of depression|1 year after inclusion to the study|Inpatients||participants|||Number
11637|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Treatment-naive participants in the Full Analysis Set (randomized, received at least 1 dose of study drug, and had chronic genotype 1 (1a, 1b, or mixed 1a/1b) HCV infection) without cirrhosis were analyzed.||percentage of participants|||Number
11638|NCT01975467|Secondary|Range of Motion and Strength|The ASES instrument will be used to assess range of motion and strength.|One time point||||||
11639|NCT01975467|Primary|DASH Score|Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.|One time point|Terminated due to low enrollment|||||
11640|NCT01975285|Secondary|Patient Satisfaction With Pain Management|Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days|||Scores on a scale||Standard Deviation|Mean
11641|NCT01975285|Secondary|Patient Satisfaction With Regional Nerve Block|Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days|||Scores on a scale||Standard Deviation|Mean
11642|NCT01975285|Secondary|Length of Analgesia|Time in days and/or hours|3 days|||Hours||Inter-Quartile Range|Median
11643|NCT01975285|Secondary|Opioid Consumption|Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|3 days|||Opioids consumption mg||Standard Deviation|Mean
11644|NCT01975285|Primary|Postoperative Pain|"Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain and 10 indicates= The worst possible pain"|3 days|||Scores on a scale||Standard Deviation|Mean
11645|NCT01975246|Secondary|The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period|Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed.|baseline and week 8|FAS||percentage of participants||95% Confidence Interval|Number
11646|NCT01975246|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|FAS||mmHg||Standard Error|Mean
11647|NCT01975246|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period.||mmHg||Standard Error|Mean
11648|NCT01974895|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|"A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 – Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
11649|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010"|During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
11650|NCT01974895|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|"pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
11651|NCT01974895|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|"MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
11652|NCT01974895|Secondary|Duration of Solicited Local and General Symptoms|"Duration was defined as number of days with any grade of local and general symptoms.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Days||Full Range|Median
11653|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|"Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
11654|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0°C.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
11655|NCT01974895|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.||Subjects|||Number
11656|NCT01974895|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
11657|NCT01974895|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
13070|NCT01945944|Secondary|Wheezing|as dichotomous outcome (yes/no) following drug administration|during mechanical ventilation (typically 4 days - 2 weeks)|||percentage of drug doses w/ wheezing|||Number
11658|NCT01974895|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|"HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
11659|NCT01974895|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
11660|NCT01974895|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
11661|NCT01974817|Primary|Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis|Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.|12 months|||µg/ml||95% Confidence Interval|Geometric Mean
11662|NCT01974752|Secondary|Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine|Overall Survival|From Randomization, up until death assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).||Number of Overall Survival Events|||Number
11663|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR|Percent change in tumour size at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).||percent change||Standard Deviation|Mean
11664|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR|ORR at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|Full Analysis Set||number of responders|||Number
11665|NCT01974752|Primary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.|Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).||number of progression events|||Number
11666|NCT01974700|Secondary|Number of Participants Who Returned to Work|The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.|6 months - 12 months|||participants|||Number
11667|NCT01974700|Secondary|Number of Participants Who Returned to Daily Activities.|The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.|6 months - 12 months|||participants|||Number
11668|NCT01974700|Primary|Incidence of Seizure|Reported via patient in follow-up phone call.|6 mo - 1 Year from Operative Procedure|||participants|||Number
11669|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
11670|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
11671|NCT01974323|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
11672|NCT01974323|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported “Very good” or “Excellent” at Week 12 are reported.|Week 12|Intent-to-Treat: all randomized patients with data at this time point||Percentage of Patients|||Number
11673|NCT01974323|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Percent Change in Lesion Count||Standard Error|Least Squares Mean
11674|NCT01974323|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Total Lesion Counts||Standard Error|Least Squares Mean
11675|NCT01974323|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Number of Noninflammatory Lesions||Standard Error|Mean
11676|NCT01974323|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients||Number of Inflammatory Lesions||Standard Error|Mean
11677|NCT01974323|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
11678|NCT01974245|Other Pre-specified|Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks||12 weeks||||||
11679|NCT01974245|Secondary|Change From Baseline in C-reactive Protein at 12 Weeks||12 weeks||||||
11680|NCT01974245|Primary|Change From Baseline in Interleukin-6 at 12 Weeks.||12 weeks|||pg/mL||Standard Deviation|Mean
11681|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
11682|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
11683|NCT01974141|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Scores on a Scale||Standard Deviation|Mean
11684|NCT01974141|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported “Very good” or “Excellent” at Week 12 are reported.|Week 12|Intent-to-Treat: all randomized patients with data at this time point, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
11685|NCT01974141|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percent Change in Lesion Count||Standard Error|Least Squares Mean
11686|NCT01974141|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Total Lesion Counts||Standard Error|Least Squares Mean
11687|NCT01974141|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Number of Noninflammatory Lesions||Standard Error|Mean
11688|NCT01974141|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Number of Inflammatory Lesions||Standard Error|Mean
11689|NCT01974141|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations||Percentage of Patients|||Number
11690|NCT01973777|Secondary|Acceptability|patient-reported acceptability|12 months|||participants|||Number
11691|NCT01973777|Secondary|Complication|infection, perforation, pregnancy|12 months|||participants|||Number
11692|NCT01973777|Primary|Expulsion Rate|The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus|at 6-8 weeks|||participants|||Number
11693|NCT01973608|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs|TEAE was defined as an AE that started on or after the first administration of SBRT. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.||subjects|||Number
11694|NCT01973608|Secondary|Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|BOR was defined as a confirmed complete response (CR) or partial response (PR) during second-line treatment. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|"Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."||subjects|||Number
11695|NCT01973608|Primary|Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)|DLT was defined as any Grade>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to <= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 8 x upper limit of normal (ULN)/total bilirubin < 5 x ULN resolving to <= Grade 1 in <7 days after medical management; Grade 3 diarrhea controlled with maximal medical management within 72 hours; Grade 4 lymphopenia that resolves to <= Grade 1 within 7 days & with no clinical manifestations; Grade 3 lab abnormality with no clinical correlation and resolves to <= Grade 1 within 7 days with adequate medical management Tumor flare defined as local pain, irritation or rash localized at sites of known/suspected tumor.|Baseline up to Day 21|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.||subjects|||Number
11696|NCT01973595|Secondary|Diet Quality|"Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).~High component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.~National averages total score: children: 54.9 [4-8 years] and adults: 57.4 [31-50 years])"|Three week almond intervention vs. three week no almond intervention|29 Parents and 29 children were analyzed separately for almonds and no almond consumption; one parent-child pair withdrew prior to no almond consumption control.||units on a scale||Standard Error|Mean
11697|NCT01973595|Secondary|Gastrointestinal Function|Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.|Pre-baseline (Week 0) and Week 3 of each intervention|29 parents and 29 children consumed almonds n=58; one parent-child pair withdrew prior to no almond consumption control intervention n=56; parents and children were analyzed for almonds and no almond consumption.||average stools per week||Standard Error|Mean
11698|NCT01973595|Secondary|Inflammatory Status|Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four.|Change between Baseline to Week 4|Parents (Almonds baseline, n=29, final n=29, No almonds baseline n=28, final n= 28; one parent withdrew prior to no almond consumption control intervention) were analyzed for almonds and no almond consumption, no children were included in this analysis.||ng/ml||Standard Error|Mean
11699|NCT01973595|Primary|Gut Microbiota Community Composition|The mean of the change between baseline and final time points in stool lactic acid bacteria counts [log(CFU)] was compared for each study arm.|Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention|Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed.||log (CFU)||Standard Error|Mean
11700|NCT01973439|Primary|Cmax of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.|Week 4|||mg/L||95% Confidence Interval|Geometric Mean
11701|NCT01973439|Primary|AUC(0-24) of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication|Week 4|||h*mg/L||95% Confidence Interval|Geometric Mean
11702|NCT01973439|Primary|Cmax of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0|||mg/L||95% Confidence Interval|Geometric Mean
11703|NCT01973439|Primary|Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0|||h*mg/L||95% Confidence Interval|Geometric Mean
11704|NCT01973413|Secondary|Glycemic Events|"Number of nights with >= 1 hypo- and hyperglycemic event occurring overnight during the camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.||nights with >= 1 event|Participants||Number
11705|NCT01973413|Secondary|Overnight Glucose|"Mean overnight glucose during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.||mg/dL|Participants|Standard Deviation|Mean
11794|NCT01971723|Primary|Dihydrotestosterone Outcomes|Measurements for dihydrotestosterone (DHT) will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
11706|NCT01973413|Primary|Percent Time Near Normoglycemia|"Percent of time in a glucose target range of 70-150 mg/dl during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.||percentage of time|Participants|Inter-Quartile Range|Median
11707|NCT01973231|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of any of the trial products.||events|||Number
11708|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post-baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||percentage (%) of subjects|||Number
11709|NCT01973231|Secondary|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)|Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||percentage (%) of subjects|||Number
11710|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||percentage (%) of subjects|||Number
11711|NCT01973231|Secondary|Change in Body Weight From Baseline|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing body weight post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the body weight analysis.||kg||Standard Deviation|Mean
11712|NCT01973231|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing FPG post baseline data, 194 and 189 subjects in liraglutide and lixisenatide treatment group, respectively were included in the FPG analysis.||mmol/L||Standard Deviation|Mean
11713|NCT01973231|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing values were imputed using predicted values from the mixed model for repeated measurements (MMRM) model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
11714|NCT01973218|Secondary|The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.|The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through Day 61|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.||number of subjects|||Number
11715|NCT01973218|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.|The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through day 7 after each vaccination|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.||Number of subjects|||Number
11716|NCT01973218|Secondary|The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.|The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.|Day 61/Day 1|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||Ratio||95% Confidence Interval|Geometric Mean
11717|NCT01973218|Secondary|The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.|The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints||IU/mL||95% Confidence Interval|Geometric Mean
11795|NCT01971723|Primary|Free Testosterone Outcomes|Measurements for free testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
21339|NCT01746264|Secondary|Total Cholesterol|Total cholesterol levels were measured by an enzymatic colorimetric assay.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
11718|NCT01973218|Secondary|The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.|Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||percentage of subjects||95% Confidence Interval|Number
11719|NCT01973218|Secondary|The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.|Day 61/ Day 1|Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints||Ratio||95% Confidence Interval|Geometric Mean
11720|NCT01973218|Secondary|The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.|The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||Titers||95% Confidence Interval|Geometric Mean
11721|NCT01973218|Primary|Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.|Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.|Day 1 and Day 61|Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.||percentage of subjects||95% Confidence Interval|Number
11722|NCT01973205|Secondary|Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.|Number of subjects who are free of phonophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing phonophobia free status at 2 hours (AA: N=403, Placebo: N = 411).||participants|||Number
11723|NCT01973205|Secondary|Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.|Number of subjects who are free of photophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing photophobia free status at 2 hours (AA: N=403, Placebo: N = 411).||participants|||Number
11724|NCT01973205|Primary|Number of Subjects Who Are Nausea Free at the 2-hour Assessment|Number of subjects who are nausea free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N=415) and had a non-missing nausea free status at 2 hours (AA: N=403, Placebo N= 411).||participants|||Number
11725|NCT01973205|Primary|Number of Subjects Who Are Pain Free at the 2-hour Assessment|Number of subjects who are pain free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing pain free status at 2 hours (AA: N=408, Placebo: N = 415).||participants|||Number
11726|NCT01972776|Secondary|Change From Baseline in Scond/Sacin as Measured by Multiple Breath Nitrogen Washout (MBNW) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11727|NCT01972776|Secondary|Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11728|NCT01972776|Secondary|Change From Baseline in Percentage Sputum Neutrophils (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11729|NCT01972776|Secondary|Tmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11730|NCT01972776|Secondary|Cmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11731|NCT01972776|Secondary|AUC0-24 (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11732|NCT01972776|Secondary|Change From Baseline in Forced Expirtory Flow 25-75 (FEF25-75), Forced Expiratory Volume 3 (FEV3)/Forced Vital Capacity (FVC), 1-(FEV3/FVC), FEV6, FEV1/FEV6 and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11733|NCT01972776|Secondary|Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) (Part 1)|Lung clearance index (LCI) is a measure of abnormal ventilation distribution derived from the multiple breath inert gas washout (MBW) technique. LCI is equal to the cumulative expired volume/functional residual capacity. LCI was measured at baseline and day 14. LCI was analyzed using a Bayesian model for repeated measurements. The model may investigate effects for pre-dose baseline, treatment, time, age, COPD class, treatment by time interaction, and baseline by time interaction. A positive change from baseline indicates improvement.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||index score||Standard Error|Mean
11734|NCT01972776|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Part 1)|FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry and performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||mL||Standard Error|Mean
11796|NCT01971723|Primary|Bio-availableTestosterone Outcomes|Measurements for total testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
11735|NCT01972776|Secondary|Change From Baseline in Chemokine (C-X-C Motif) Receptor 2 (CXCR2) Receptor Occupancy (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CXCR2 receptor occupancy on neutrophils. A positive change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||percent change|||Number
11736|NCT01972776|Secondary|Change From Baseline in Cluster of Differentiation 11b (CD11b) (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CD11b expression on neutrophils. A negative change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.||percentage change|||Number
11737|NCT01972776|Secondary|Tmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.||hours||Full Range|Median
11738|NCT01972776|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.||hours||Full Range|Median
11739|NCT01972776|Secondary|Cmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.||ng/mL||Standard Deviation|Mean
11740|NCT01972776|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.||ng/mL||Standard Deviation|Mean
11741|NCT01972776|Secondary|AUCtau, Steady State (AUCtau,ss) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.||ng*h/mL||Standard Deviation|Mean
11742|NCT01972776|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval, Tau (AUCtau) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.||ng*h/mL||Standard Deviation|Mean
11743|NCT01972776|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11744|NCT01972776|Primary|Change From Baseline in Transition Dyspnea Index (TDI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11745|NCT01972776|Primary|Change From Baseline in Absolute Number of Sputum Neutrophils (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11746|NCT01972776|Primary|Change From Baseline in Lung Clearance Index (LCI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.|||||
11747|NCT01972776|Primary|Percentage of Participants With Adverse Events (Part 1)|Adverse events were counted and corresponding percentages were tabulated.|14 days|All randomized part 1 participants||percentage of participants|||Number
11748|NCT01972659|Secondary|Postoperative Morphine Consumption||after 12 hour surgery||||||
11749|NCT01972659|Secondary|Rocuronium Supplementation||during surgery||||||
11750|NCT01972659|Secondary|Rocuronium Onset Time||during the surgery||||||
11751|NCT01972659|Primary|TOF 0.9 Achieving Time||end of the surgery|||minutes||Standard Deviation|Mean
11752|NCT01972516|Secondary|Quality of Life (QOL) Evaluation|To evaluate the impact of treatment with Tivozanib versus placebo alone on the Quality of Life (QOL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC QLQ-Ovarian Cancer Module (EORTC QLQ-OV28) for functioning and symptoms.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
11753|NCT01972516|Secondary|Toxicity Rate Comparison|To compare rates of toxicity with and without maintenance therapy with Tivozanib.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
11754|NCT01972516|Secondary|Overall Survival (OS) Evaluation|To evaluate the overall survival with and without maintenance therapy with Tivozanib in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
11755|NCT01972516|Secondary|Progression-Free Survival (PFS) Evaluation|To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.|||||
11756|NCT01972516|Primary|Progression-Free Survival (PFS) Comparison|"To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)"|2 Years|Reporting the number of cycles each patient completed. Each cycle = 4 weeks.||Cycles|||Number
11757|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||mOsm/L|eyes|Standard Deviation|Mean
11797|NCT01971723|Primary|Insulin-like Growth Factor-I Outcomes|Measurements for insulin-like growth factor-I will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
23169|NCT01714492|Primary|Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity||10 yrs post-operative|||degrees|Participants|Standard Deviation|Mean
11758|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||mOsm/L|eyes|Standard Deviation|Mean
11759|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 6 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||mOsm/L|eyes|Standard Deviation|Mean
11760|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 3 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||mOsm/L|eyes|Standard Deviation|Mean
11761|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||seconds|eyes|Standard Deviation|Mean
11762|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 6 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||seconds|eyes|Standard Deviation|Mean
11763|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||seconds|eyes|Standard Deviation|Mean
11764|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 3 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||seconds|eyes|Standard Deviation|Mean
11765|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 6 Months Compared to Baseline.|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||ETDRS letters|eyes|Standard Deviation|Mean
11766|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||ETDRS letters|eyes|Standard Deviation|Mean
11767|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||ETDRS letters|eyes|Standard Deviation|Mean
11768|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 3 Months Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||ETDRS letters|eyes|Standard Deviation|Mean
11798|NCT01971723|Primary|Estrogen Outcomes|Measurements for estrogen will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||pg/ml||Standard Deviation|Mean
11799|NCT01971723|Primary|Total Testosterone Outcomes|Measurements for testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ng/dL||Standard Deviation|Mean
11769|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 6 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
11770|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 6 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
11771|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 3 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
11772|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 3 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
11773|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
11774|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 6 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.||scores on a scale|eyes|Standard Deviation|Mean
11775|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
11776|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 3 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.||scores on a scale|eyes|Standard Deviation|Mean
11777|NCT01972438|Secondary|Number of Participants Withdrawn From the Study Treatment Due to Vision Loss, Adverse Events or Treatment Failure||Study Duration, up to 24 months|||participants|||Number
11779|NCT01972438|Primary|Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale in the Study Eye From Baseline to Month 3.|A ≥ 50% reduction in the combined score was considered a treatment success. While the design is a crossover study, the primary outcome was assessed after the first period at Month 3. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 months|This analysis is conducted on the per-protocol population, defined as those who adhered to the protocol prior to drug unavailability, not on the intent-to-treat population due to lack of visit information beyond baseline for 3 participants. Three never started drug: one was unable to donate blood, one was ineligible at screening and one died.||participants|eyes||Number
11780|NCT01972152|Secondary|Glucagon Tmax|Pharmacokinetic parameter: Time to maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||minutes||Standard Deviation|Mean
11781|NCT01972152|Secondary|Glucagon Cmax|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||pg/ml||Standard Deviation|Mean
11782|NCT01972152|Secondary|Glucagon AUC|Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||min*pg/ml||Standard Deviation|Mean
11783|NCT01972152|Secondary|Glucose Tex|Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||minutes||Standard Deviation|Mean
11784|NCT01972152|Secondary|Glucose MAE|Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||mg/dL||Standard Deviation|Mean
11785|NCT01972152|Secondary|Glucose AUCex|Pharmacodynamic parameter: Area Under the Glucose Excursion Curve|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||min*mg/dL||Standard Deviation|Mean
11786|NCT01972152|Secondary|Glucose Tmax|Pharmacodynamic parameter: Time to Maximum Glucose Concentration|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||minutes||Standard Deviation|Mean
11787|NCT01972152|Secondary|Glucose Cmax|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||mg/dL||Standard Deviation|Mean
11788|NCT01972152|Secondary|Glucose Area Under the Curve (AUC)|Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.||min*mg/dL||Standard Deviation|Mean
11789|NCT01972152|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment group|From first dose until completion of the post-treatment follow-up visit, up to 6 weeks|All subjects receiving treatment were included in this analysis.||events|||Number
11790|NCT01971723|Primary|Creatine-Kinase Outcomes||Baseline, 2-week mark, 4-week mark|||mkat/L||Standard Deviation|Mean
11791|NCT01971723|Primary|Sex-hormone Binding Globulin Outcomes||Baseline, 2-week mark, 4-week mark|||nmol/l||Standard Deviation|Mean
11792|NCT01971723|Primary|Cortisol Outcomes||Baseline, 2-week mark, 4-week mark|||ug/dl||Standard Deviation|Mean
11800|NCT01971723|Primary|Blood Lipid Outcomes|Measurements for blood lipid panels will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||mg/dl||Standard Deviation|Mean
11801|NCT01971723|Primary|Insulin Outcomes|Measurements of insulin will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark|||ulU/ml||Standard Deviation|Mean
11802|NCT01971723|Primary|Strength Performance Outcomes|"Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench, and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period.~Each measure was only compared within it's own category against the baseline measurement and against that of the other group at the same time point."|Baseline measures and 4 weeks from start of study|||Kg||Standard Deviation|Mean
11803|NCT01971554|Secondary|Change From Baseline in 24-Hour Weighted Mean Glucose (24h-WMG) at Day 15|"The 24h-WMG was considered to provide an integrated assessment of the glycemic exposure over the 24-hour period, and was derived from 18 blood samples collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. On each day (Day -1 and Day 14), the WMG was computed as a time-weighted average of the 18 individual measurements."|Baseline and Day 15|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Data from 1 participant at Day 14 (Placebo group) was missing as the participant had to leave the study site.||mg/dL||Standard Error|Least Squares Mean
11804|NCT01971554|Secondary|Time to Reach Cmax (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.||hr||Full Range|Median
11805|NCT01971554|Secondary|Maximum Plasma Drug Concentration After Dosing (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for Cmax was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.||μM||Geometric Coefficient of Variation|Geometric Mean
11806|NCT01971554|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to 24 hours after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for AUC0-24h was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.||μM·hr||Geometric Coefficient of Variation|Geometric Mean
11807|NCT01971554|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 14 days|The Safety population consisted of all participants who received at least one dose of study medication.||Participants|||Number
11808|NCT01971554|Primary|Number of Participants Who Experienced at Least Once Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 28 days|The Safety population consisted of all participants who received at least one dose of study medication.||Participants|||Number
11809|NCT01971554|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15|Blood glucose was measured on a fasting basis (collected after an 8-hour fast). Blood was collected on Day -1 (pre-planned dose), predose on Days 1, 3, 7, and 14, and 24h postdose Day 14 (Day 15). The baseline measurement was computed as the average of the Day -1 and predose Day 1 measurements. FPG is expressed as mg/dL. This change from baseline reflects values for Day 15 FPG minus Day 0 FPG values.|Predose (Baseline) and 24 h postdose Day 14 (Day 15)|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model.||mg/dL||Standard Error|Least Squares Mean
11810|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from TS||participants|||Number
11811|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.|The tolerability of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from TS.||participants|||Number
11812|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from FAS||participants|||Number
11813|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from FAS.||participants|||Number
11814|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your sleep? and How did Rhinospray Plus improve the quality of your sleep?."|Up to day 11|Patients from FAS||participants|||Number
11815|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your daytime activities?"|up to 11 days|Patients from FAS||participants|||Number
11816|NCT01971086|Secondary|The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit|Patients scored the single symptoms (blocked nose, sneezing and running nose) at the end of each treatment day on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The changes in the 3 single scores were calculated by the single score at the final visit minus the single score at baseline. Therefore, a negative change represents an improvement of the single scores.|Baseline and up to day 11|Patients from FAS.||units on a scale||Full Range|Median
11817|NCT01971086|Primary|The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep|"The mean score of the following two quality of life improvement questions at the final/closing visit was calculated: How did Rhinospray plus improve the quality of your daytime activities? and How did Rhinospray Plus improve the quality of your sleep?. The scores range from 1=strongly to 4=no improvement. Thus also the range of the mean score is from 1 to 4."|up to day 11|Patients from FAS||units on a scale||Full Range|Median
11818|NCT01971086|Primary|The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.|Patients scored the symptoms (blocked nose, sneezing and running nose) on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The range of the mean score thus could be between 0 and 3. The change in the mean of the 3 single scores was calculated by the score at the final visit minus the score at baseline. Therefore, a negative change represents an improvement of the mean score.|Baseline and up to day 11|Patients from the Full Analysis Set (FAS) which includes all patients in the TS who have analysable data in at least one efficacy endpoint.||units on a scale||Full Range|Median
11819|NCT01970995|Primary|Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)|"Concentrations measured at Day 90 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|90 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the period Day 60 to Day 90.||pg/mg creat||95% Confidence Interval|Least Squares Mean
11820|NCT01970995|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
11821|NCT01970995|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||pg/mg creat||95% Confidence Interval|Least Squares Mean
11822|NCT01970995|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||ng/mg creat||95% Confidence Interval|Least Squares Mean
11823|NCT01970995|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.||pg/mg creat||95% Confidence Interval|Least Squares Mean
11824|NCT01970982|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
11825|NCT01970982|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
11826|NCT01970982|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||ng/mg creat||95% Confidence Interval|Least Squares Mean
11827|NCT01970982|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
11828|NCT01970878|Secondary|Change From Baseline in Average Daily Rescue Ventolin Use|Change From Baseline in average daily rescue Ventolin use over 52 Weeks as a Model-Based Average (ITT Population)|Baseline through Week 52|||Puffs per day||95% Confidence Interval|Least Squares Mean
11829|NCT01970878|Secondary|Change From Baseline in SGRQ Total Score|Change From Baseline in SGRQ Total Score over 52 Weeks as a Model-Based Average (ITT Population) The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life|Baseline and Weeks 12 to 52|||Scores on a scale||95% Confidence Interval|Least Squares Mean
11830|NCT01970878|Secondary|Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing|Peak Change From Baseline in FEV1 within 2 hrs post-dosing over 52 Weeks as a Model-Based Average (ITT Population)|Baseline and Weeks 2 to 52|||Liters||95% Confidence Interval|Least Squares Mean
11831|NCT01970878|Secondary|Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks|SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.|Baseline and Weeks 4 to 52|||Scores on a scale||95% Confidence Interval|Least Squares Mean
11832|NCT01970878|Primary|Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks|Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population)|Baseline and Weeks 2 to 52|||Liters||95% Confidence Interval|Least Squares Mean
11833|NCT01970787|Secondary|Progression of HSIL to Cancer|Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.|12 months||||||
11834|NCT01970787|Secondary|Adverse Events|Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.|12 months|||participants|||Number
11835|NCT01970787|Secondary|Tolerability|"Subject tolerability of the RFA procedure as measured by severity. Mild: Awareness of signs and symptoms, but easily tolerated; are of a minor irritant type; causing no loss of time from normal activities; symptoms would not require medication or a medical intervention; asymptomatic lab findings; marginal clinical relevance; signs and symptoms are transient.~Moderate: Discomfort severe enough to cause interference with usual activities; minimal intervention.~Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may be of systemic nature or require medical evaluation or treatment."|12 months|||participants|||Number
11836|NCT01970787|Secondary|Feasibility and Ease of Technique|"Technical feasibility of applying RFA to the anal canal. Physician's assessment of ablation as optimal (complete ablation) versus sub-optimal (incomplete ablation)in the affected area in the anal canal.~Data not collected and could not be analyzed"|12 months||||||
11837|NCT01970787|Primary|Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)|Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment|12 months|||participants w histological clearance|||Number
11838|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 50|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.||percentage of participants|||Number
11839|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 32|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of participants|||Number
11840|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 16|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
11841|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 50|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.||percentage of participants|||Number
11886|NCT01969435|Secondary|Disease-free Survival|For patients with CR at day +100. Proportion of patients who survive without any signs or symptoms of cancer at 2 years.|2 years||05/2017||||
11887|NCT01969435|Secondary|Disease-free Survival|Percentage of patients who survive without any signs or symptoms of cancer at 1 year.|1 year|||percentage of participants||95% Confidence Interval|Number
26169|NCT01664975|Secondary|Response Rate|21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles|every 6 weeks,up to completion of treatment(approximately 18 weeks )||09/2016||||
11842|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 32|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of participants|||Number
11843|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 16|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
11844|NCT01970488|Secondary|Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).~Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.|Results are reported for the anti-drug antibody analysis set (defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable antibody test) from Baseline to Week 16 for all randomized participants, and from baseline to Week 52 for participants who were re-randomized.||percentage of participants|||Number
11845|NCT01970488|Secondary|Number of Participants With Adverse Events|"The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.~A serious AE is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups."|From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.|The safety analysis set includes all randomized participants who received at least 1 dose of study drug, based on actual treatment received.||participants|||Number
11846|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from Baseline (negative value) indicates improvement."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data||percentage of BSA||Standard Deviation|Mean
11847|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from Baseline (negative value) indicates improvement."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of BSA||Standard Deviation|Mean
11848|NCT01970488|Secondary|Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from baseline (negative value) indicates improvement."|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of BSA||Standard Deviation|Mean
11849|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 50|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 50|This analysis was performed in the re-randomized analysis set with available data.||percentage of participants|||Number
11850|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 32|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 32|This analysis was performed in the re-randomized analysis set with available data||percentage of participants|||Number
11851|NCT01970488|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) Response at Week 16|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
12111|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
11852|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 50|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline is calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data||percent change||Standard Deviation|Mean
11853|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 32|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline is calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data||percent change||Standard Deviation|Mean
11854|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 50|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 50|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 50 are included.||percentage of participants|||Number
11855|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 32|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 32|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 32 are included.||percentage of participants|||Number
11856|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 16|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.||percentage of participants|||Number
11857|NCT01970488|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline was calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and Week 16|This analysis was performed using the full analysis set which includes all participants initially randomized in the study. Last observation carried forward (LOCF) imputation was used for participants with at least one post-baseline value.||percent change||Standard Deviation|Mean
11858|NCT01970475|Secondary|Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).~Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|Up to week 26|Participants with at least 1 evaluable antibody test result (to either ABP 501 or adalimumab)||percentage of participants|||Number
11859|NCT01970475|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:~1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question “is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product” was yes.~A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening (places the subject at immediate risk of death)~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.|The safety analysis set (all participants who received at least 1 dose of study drug)||participants|||Number
11860|NCT01970475|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and Week 24|Full analysis set with available data at week 24||percentage of participants|||Number
11861|NCT01970475|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and week 24|Full analysis set with available data at week 24||percentage of participants|||Number
11862|NCT01970475|Secondary|Percentage of Participants With an ACR20 Response at Week 2 and Week 8|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline, week 2 and week 8|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value (indicated by n).||percentage of participants|||Number
11863|NCT01970475|Secondary|Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).~The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity.~A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed."|Baseline and weeks 2, 4, 8, 12, 18, and 24|Full analysis set with available data at each time point||units on a scale||Standard Deviation|Least Squares Mean
11864|NCT01970475|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and Week 24|The full analysis set (all randomized participants); missing values were imputed using the last observation carried forward (LOCF) method for participants with at least 1 postbaseline value.||percentage of participants|||Number
11865|NCT01970397|Secondary|Subject's Global Assessment of Change in Appearance of Perioral Lines|The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.|Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available at the given time-point.||units on a scale||95% Confidence Interval|Mean
11866|NCT01970397|Secondary|Participant Assessed Procedural and Post-Procedural Pain Levels|The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.|During injection, immediately following injection, 15, 30, and 45 min post-injection|Intent-to-treat population included all randomized and treated participants.||units on a scale||95% Confidence Interval|Mean
11867|NCT01970397|Primary|Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The investigator evaluated the severity of the participant’s upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.|Baseline, Month 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available for analysis at Month 6.||percentage of participants|||Number
11868|NCT01969747|Primary|Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo|"Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo.~The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model.~The primary endpoint is exploratory."|baseline (Day -1) and 7 days after first drug administration (Day 7)|"Full analysis set (FAS): all patients randomised, treated with at least one dose of study drug, had a baseline UGE (g/24 h) and a UGE (g/24 h) on Day 1 or Day 7.~The last observation carried forward (LOCF) approach was used as the primary method of imputation for missing data."||g/24h||Standard Error|Mean
11869|NCT01969721|Secondary|FEV1 Peak (0−3h) Change From Patient Baseline After 6 Weeks of Treatment|Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
11888|NCT01969435|Secondary|Efficacy as Measured by Response Rates|"The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion.~Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma"|Up to Day 100|||percentage of participants|||Number
11870|NCT01969721|Secondary|FEV1 AUC (12−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
11871|NCT01969721|Secondary|Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
11872|NCT01969721|Secondary|FEV1 AUC (0−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.~Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
11873|NCT01969721|Primary|FEV1 AUC (0−12h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.||Litres||Standard Error|Mean
11874|NCT01969565|Secondary|Overall Response Rate (ORR), Defined as sCR, CR, Very Good Partial Response (VGPR), and PR at 4 Cycles||4 months||||||
11875|NCT01969565|Primary|Phase 2: Patients With >= VGPR (Very Good Partial Response)|The overall response rate will be estimated based on the crude proportion of subjects for whom best overall response is stringent complete response (sCR), complete response (CR), VGPR, and partial response (PR).|4 months-8months||||||
11876|NCT01969565|Primary|Tolerability and Safety of Increasing Doses of Carfilzomib in Combination With Dexamethasone.|"Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) adverse event dictionary. The results will be tabulated to examine their frequency, organ systems affected, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly.~The study is designed to evaluate the efficacy and safety of carfilzomib in combination with dexamethasone. Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles."|24 months|Patient withdrew consent before receiving treatment|||||
11877|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Albuterol|"Pre-dose subtracted maximum measured concentration (Cmax) of albuterol.~Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set||ng/ml||Standard Deviation|Mean
11878|NCT01969539|Secondary|Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol|"Area under the concentration-time curve over the time interval from 0 to 6 hour (AUC 0-6) of ipratropium and albuterol.~This secondary endpoint was not calculated due to a carry-over effect."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set|||||
11879|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Ipratropium|"Pre-dose subtracted maximum measured concentration (Cmax) of ipratropium.~Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set||pg/ml||Standard Deviation|Mean
11880|NCT01969435|Post-Hoc|Overall Survival (OS) Rate||Median follow-up 15.4 months (range 4.7-24.6)|||percentage of participants|||Number
11881|NCT01969435|Post-Hoc|Relapse Free Survival||1 year|||percentage of participants|||Number
11882|NCT01969435|Post-Hoc|Progression-free Survival Rate (PFS)||1 year|||percentage of participants||95% Confidence Interval|Median
11883|NCT01969435|Post-Hoc|Progression-free Survival (PFS) Rate|PFS - Time from start of treatment to the time of progression or death, whichever occurs first.|6 months|||percentage of participants||95% Confidence Interval|Median
11884|NCT01969435|Secondary|Time to Engraftment (Platelet)|Time from the date of transplant to the date of platelet engraftment.|Assessed up to day 100|One patient did not have platelet engraftment by Day 100||days||Full Range|Median
11885|NCT01969435|Secondary|Time to Engraftment (Neutrophil)|Time from the date of the transplant to the date of neutrophil engraftment.|Assessed up to day 30|||days||Full Range|Median
11890|NCT01969435|Primary|Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events|Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.|Day -7 through Day 30|||participants|||Number
11891|NCT01969162|Primary|Tear Lipid Composition Profile|Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).|Day 1|A subset of enrolled participants who had non-stimulated (basal) tear samples.||pmole||Standard Deviation|Mean
11892|NCT01969084|Secondary|Changes in Circulating Endothelial Progenitor Cell Phenotypes|The measurements of the various EPC phenotypes were performed at the Beth Israel Deaconess Flow Cytometry Core Facility. Immunofluorescent cell staining was performed on peripheral blood with the use of the fluorescent conjugated antibodies. 1.000.000 events per sample were acquired using a FACS LSR II analyzer (Becton Dickinson, Franklin Lakes, NJ, USA) and the results were analyzed using the Beckman Coulter Kaluza analysis software (Beckman Coulter Inc., Brea, CA, USA).|Baseline and 12 weeks|||Events per million||Inter-Quartile Range|Median
11893|NCT01969084|Secondary|Changes in SDF1-α and Substance P||Baseline and 12 weeks|||pg/ml||Inter-Quartile Range|Median
11894|NCT01969084|Secondary|Changes in Vascular Reactivity in the Micro- and Macro-circulation.|Change in markers of macro- and microvascular function from the baseline visit to the post-treatment visit between the two groups.|Baseline and 12 weeks|||percent change||Inter-Quartile Range|Median
11895|NCT01969084|Secondary|Change in Muscle Oxygenation Recovery Time|Change in muscle oxygenation after ischemia inducing occlusion for 4 minutes.|Baseline and 12 weeks|||seconds||Inter-Quartile Range|Median
11896|NCT01969084|Primary|Phosphocreatine (PCR) Recovery Time After Exhaustive or up to 6 Minutes of Leg Exercise.|Change in the time to phosphocreatine recovery between the baseline visit and post-treatment visit following the graded exercise test.|Baseline and 12 weeks|||seconds||Inter-Quartile Range|Median
11897|NCT01968811|Primary|To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings|"Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0~Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0"|From 1 to 3 visit, depending on each subject/wound, up to 4 days.|10 patients were enrolled and individually analysed and presented in the study||number of surgeons|||Number
11898|NCT01968811|Secondary|- Fascial/Skin Closure of the Open Abdomen|The performance objective is assessed through general application and removal questions after each investigational device handling.|End of treatment, up to 4 days.|No. Analysed for efficacy ITT 10 , PP 9,||participants|||Number
11899|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.||cells/μL||Standard Deviation|Mean
11900|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.||cells/μL||Standard Deviation|Mean
11901|NCT01968551|Secondary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set||percentage of participants|||Number
11902|NCT01968551|Primary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set (FAS) in Cohort 2, included all participants who (1) were randomized to Cohort 2 and (2) received at least 1 dose of study drug during the Randomized Phase.||percentage of participants|||Number
11903|NCT01968434|Secondary|Change in Day Cough Score at End of Study (From D0 to D4)|"A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every day of the trial is rated. The last evening of the study (D4) the parents rated the passed day by scoring from 0-6 each of the 3 aspects of day cough. The summed score for all aspects gives the combined day cough score. This score, ranging between 0-18, was subtracted from the sum of all aspects, also ranging between 0-18, form the basal day cough score of the day before enrollment (D0). This change is recorded as change in combined day cough score and it refers to the change from D0 to D4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|Two patients in the protective syrup group, and 5 patients in the carbocysteine group did not complete the questionnaire for the last day.||change in combined day cough score||Standard Error|Mean
11927|NCT01967147|Secondary|Change From Baseline in TOSS Score at Day 35|The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
11904|NCT01968434|Secondary|Change in Night Cough Score at End of Study (From N0 to N4)|"A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the passed night. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every night of the trial is rated. The morning after the last night of the study (N4) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The summed score for all aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|Two patients from the protective syrup group and 6 patients from the carbocysteine group did not anwser the questions for the last night.||change in combined night cough score||Standard Error|Mean
11905|NCT01968434|Primary|Change in Night Cough Score on First Night of Treatment (From N0 to N1)|"Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient."|1 night from before enrollement (N0) to first night after treatment (N1)|the population analyzed are the children who completed the protocol and submitted the complete questionnaire for night and day cough||change in combined night cough score||Standard Error|Mean
11906|NCT01968135|Secondary|Number of Days to Recurrence of Bleeding After Discontinuation of Therapy||Up to six months|||days||Full Range|Median
11907|NCT01968135|Secondary|Number of Days Without Bleeding During Therapy||Over the 14 day course of study drug|||days||Full Range|Median
11908|NCT01968135|Secondary|Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred||over the 14 day course of study drug|||days||Full Range|Median
11909|NCT01968135|Primary|Cessation of Vaginal Bleeding|Proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.|At day 3 of 14 day course of study drug|||percentage of participants|||Number
11910|NCT01967784|Primary|Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine|Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set.||Percentage of participants|||Number
11911|NCT01967784|Primary|Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set.||Titers ratio||95% Confidence Interval|Geometric Mean
11912|NCT01967784|Primary|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.|Day 21 post-vaccination|Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
11913|NCT01967784|Primary|Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was analyzed in the Immunogenicity Analysis Set.||Percentage of participants|||Number
11914|NCT01967784|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were analyzed in the Immunogenicity Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
11915|NCT01967732|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||h*ng/mL||95% Confidence Interval|Least Squares Mean
11943|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes|||percentage of investigators|Participants||Number
11916|NCT01967732|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng/mL||95% Confidence Interval|Least Squares Mean
11917|NCT01967719|Primary|Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||h*ng/mL||95% Confidence Interval|Least Squares Mean
11918|NCT01967719|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares (geometric LS) means are provided."|3 days|Pharmacokinetics (PK) populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.||ng/mL||95% Confidence Interval|Least Squares Mean
11919|NCT01967706|Primary|Ratio of the Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT|"The ratios mTHS:mCC and mTHS:NRT of AUC(0-last) takes into consideration the blood measurements taken at both Day 1 (mTHS) and Day 3 (mCC, NRT) for the sequences mTHS then mCC and THS then NRT, and Day 1 (mCC, NRT) and Day 3 (mTHS) for the sequences mCC then mTHS and NRT then mTHS."|Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use)|"Ratio mTHS:mCC => Group 1, sequences mTHS then mCC (21 subjects + 1 voluntary withdrawal) + mCC then mTHS (22 subjects)~Ratio mTHS:NRT => Group 2, sequences mTHS then NRT (9 subjects) + NRT then mTHS (9 subjects)"||percentage of [ng*h/mL]||95% Confidence Interval|Least Squares Mean
11920|NCT01967706|Primary|Ratios of the Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT|"The ratios mTHS:mCC and mTHS:NRT of Cmax takes into consideration the blood measurements taken at both Day 1 (mTHS) and Day 3 (mCC, NRT) for the sequences mTHS then mCC and mTHS then NRT, and Day 1 (mCC, NRT) and Day 3 (mTHS) for the sequences mCC then mTHS and NRT then mTHS."|Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use)|"Ratio mTHS:mCC => Group 1, sequences mTHS then mCC (21 subjects + 1 voluntary withdrawal) + mCC then mTHS (22 subjects)~Ratio mTHS:NRT => Group 2, sequences mTHS then NRT (9 subjects) + NRT then mTHS (9 subjects)"||percentage of [ng/mL]||95% Confidence Interval|Least Squares Mean
11921|NCT01967550|Primary|Measure: Pain On Movement (POM)|POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.|2 weeks|The modified ITT (mITT) population excludes subjects in the ITT population who were incorrectly instructed by the investigator to treat only one knee. The mITT population is primary for the analysis of efficacy.||units on a scale||Standard Deviation|Mean
11922|NCT01967277|Primary|Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks|||terminal hairs||Standard Deviation|Mean
11923|NCT01967277|Primary|Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks|||percent change||Standard Deviation|Mean
11924|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
11925|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
11926|NCT01967147|Secondary|Change From Baseline in OSDI Score at Day 35|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||units on a scale||Standard Error|Mean
11944|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)|Day 2 - 30 minutes|||millimeters|Participants|Standard Deviation|Mean
11928|NCT01967147|Primary|Change From Baseline in TFBUT at Day 35|TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.||seconds||Standard Error|Mean
11929|NCT01967121|Primary|Pain Scores on the Visual Analog Scale|Visual Analog Scale for Muscle Soreness scale The scale for measuring the intensity of muscle soreness will be a 10 cm visual analog scale, spaced by one centimeter increments from one to 10. Ten will represent the maximum amount of soreness and zero represents no soreness at all. Subjects will be asked to complete this scale once per day at the same time of day until the soreness has dissipated. The Visual Analog Scale for muscle soreness is measured as 'scores on a scale'.|Day 1 through Day 5|||scores on a scale||Standard Deviation|Mean
11930|NCT01966926|Secondary|Changes in Perceptions of Weight Tracking|Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study. The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking. A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|three to six months|||units on a scale||Standard Deviation|Mean
11931|NCT01966926|Secondary|Changes in Barriers to Weight Tracking|Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study. The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing. A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
11932|NCT01966926|Secondary|Changes in Body Image|Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire. The subscale has a range of 0 to 42, with higher scores indicating better body image. A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
11933|NCT01966926|Secondary|Changes in Anxiety|Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA. Possible scores on the scale range from 0-63. Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
11934|NCT01966926|Secondary|Changes in Depression Ratings|Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA). Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms. Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.|baseline to 6 months|||units on a scale||Standard Deviation|Mean
11935|NCT01966926|Primary|Adherence to Weight Tracking Instructions|Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).|6 months|All participants were included in the analysis.||percentage of postcards returned|||Number
11936|NCT01966770|Primary|Overall Ease of Lens Handling (Day 2 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy|Day 2 - After Removal|||units on a scale||Standard Deviation|Mean
11937|NCT01966770|Primary|Overall Ease of Lens Handling (Day 1 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy|Day 1 - After Removal|||units on a scale||Standard Deviation|Mean
11938|NCT01966770|Primary|Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion|||percentage of investigators|||Number
11939|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion|||percentage of investigators|||Number
11940|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion|||percentage of investigators|||Number
11941|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1 - 30 minutes|||percentage of investigators|Participants||Number
11942|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes|||percentage of investigators|Participants||Number
11945|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 2 - 30 minutes|||percentage|Participants|Standard Deviation|Mean
11946|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 2 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 2 - 30 minutes|||percentage of lenses|Participants||Number
11947|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)|Day 1 - 30 minutes|||millimeter|Participants|Standard Deviation|Mean
11948|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 1 - 30 minutes|||percentage|Participants|Standard Deviation|Mean
11949|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 1 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 1 - 30 minutes|||percentage of lenses|Participants||Number
11950|NCT01966770|Primary|Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)|Baseline|||millimeters|Participants|Standard Deviation|Mean
11951|NCT01966770|Primary|Lens Fitting Characteristics, Tightness (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Baseline|||percentage|Participants|Standard Deviation|Mean
11952|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Habitual Lens)|Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Baseline|||percentage of eyes|Participants||Number
11953|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes|||percentage of participants|||Number
11954|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes|||percentage of participants|||Number
11955|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - 30 minutes|||percentage of participants|||Number
11956|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion|||percentage of participants|||Number
11957|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion|||percentage of participants|||Number
11958|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion|||percentage of participants|||Number
11959|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes|||percentage of participants|||Number
11960|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes|||percentage of participants|||Number
11979|NCT01966354|Secondary|First Attempt Cannulation|"Any cannulation that has been accomplished with a single cannulation attempt will be considered a first attempt cannulation. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)|||participants|||Number
11961|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes|||percentage of participants|||Number
11962|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion|||percentage of participants|||Number
11963|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 Insertion|||percentage of participants|||Number
11964|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion|||percentage of participants|||Number
11965|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever|Day 2 - 30 minutes|||units on a scale||Standard Deviation|Mean
11966|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever|Day 2 - Insertion|||units on a scale||Standard Deviation|Mean
11967|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)|Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - 30 minutes|||units on a scale||Standard Deviation|Mean
11968|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 1 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - Insertion|||units on a scale||Standard Deviation|Mean
11969|NCT01966770|Primary|Visual Acuity (VA) logMAR (Study Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)|Dispense|||LogMAR||Standard Deviation|Mean
11970|NCT01966770|Primary|Visual Acuity (VA) logMAR (Habitual Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)|Baseline|||LogMar||Standard Deviation|Mean
11971|NCT01966718|Secondary|Change From Baseline in the C-Reactive Protein (CRP) Level|CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.|From baseline to week 16|||mg/dL||Full Range|Mean
11972|NCT01966718|Secondary|Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)|ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased|From baseline to week 16|||mm/hr||Full Range|Mean
11973|NCT01966718|Primary|Change From Baseline in the 20-item Health Assessment Questionnaire Score|"Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from able to do with no difficulties to unable to do. A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16."|From baseline to week 16|||units on a scale||Full Range|Mean
11974|NCT01966718|Primary|Change From Baseline in the Ritchey-Camp Articular Index|Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.|From baseline to week 16|||joints|Participants|Full Range|Mean
11975|NCT01966380|Primary|Absorption of Wound Exudates.|Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT|2-3 weeks|Participants served as their own controll, those the total amount of participants is reflekted in both of the outcome measurements.||Total no. assess. in each wounddressing|Participants||Number
11976|NCT01966354|Secondary|Infectious Complications|The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn. Patients will be followed for the duration of central venous access, an expected average of 8 weeks. The number of patients with bacterial colonization and catheter-related blood stream infection will be registered.|Once the central venous catheter is withdrawn (2 months)|||participants|||Number
11977|NCT01966354|Secondary|Mechanical Complications|The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement. This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed.|At the end of the cannulation process (180 seconds, maximum)|||participants|||Number
11978|NCT01966354|Secondary|Cannulation Time|Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein. This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)|||seconds||Standard Deviation|Mean
12034|NCT01965535|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
11980|NCT01966354|Secondary|Number of Cannulation Attempts|Number of cannulation attempts that have taken place before cannulation success. Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)|||attempts||Standard Deviation|Mean
11981|NCT01966354|Primary|Cannulation Success|"Cannulation will be considered as successful once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered unsuccessful. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)|||participants|||Number
11982|NCT01966159|Other Pre-specified|Target Lesion Failure (TLF) Rate|Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non–Q-wave) related to the target vessel, or (cardiac) death.|12 months post-index procedure|||percentage of participants|||Number
11983|NCT01966159|Secondary|Target Lesion Revascularization (TLR) Rate|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months post-index procedure|||percentage of participants|||Number
11984|NCT01966159|Primary|The In-stent Late Loss Measured by Quantitative Coronary Angiography||at 9 months post-index procedure.|||mm||Standard Deviation|Mean
11985|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last PDT (PP)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Per Protocol Set (PP)||percentage of participants||95% Confidence Interval|Number
11986|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from “very good” (0) to “impaired” (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
11987|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from “very good” (0) to “impaired” (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
11988|NCT01966120|Secondary|Change of Total Lesion Area 12 Weeks After Last PDT|The fifth key secondary efficacy variable in the hierarchic test procedure was the change from baseline in the total lesion area per patient assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of lesion area change||Standard Deviation|Mean
11989|NCT01966120|Secondary|Patient Partial Response 12 Weeks After Last PDT|The fourth key secondary efficacy variable in the hierarchic test procedure was the patient partial response (defined as complete clearance of at least 75% of treated AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
11990|NCT01966120|Secondary|Lesion Complete Response 12 Weeks After Last PDT|The third key secondary efficacy variable in the hierarchic test procedure was the lesion complete response (completely cleared individual AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of lesions|Number of Lesions Analyzed|95% Confidence Interval|Number
11991|NCT01966120|Secondary|Patient Complete Response 12 Weeks After PDT 1|The second key secondary efficacy variable in the hierarchic test procedure was the patient complete response (complete clearance of all treated AK lesions) assessed at 12 weeks after PDT 1.|12 weeks after PDT 1|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
12035|NCT01965535|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24||Weeks 1, 2, 4, 8, 12, and 24|Full Analysis Set||percentage of participants|||Number
11992|NCT01966120|Secondary|Patient Histopathological Confirmed Response Rate|"For the secondary confirmatory analysis, several superiority hypotheses were tested within a pre-defined hierarchic multiple testing procedure as described in the Statistical Analysis Protocoll (SAP).~The key secondary efficacy variables were tested strictly in a pre-defined order to ensure the family-wise error rate (FWER) and the testing procedure had to be stopped once the first non-significant test was obtained.~The results of the confirmatory analysis are presented in the order pre-defined by the confirmatory testing procedure.~Assessments of the patient histopathological confirmed response (HCR) rates were based on the results from the biopsy taken 12 weeks after the last PDT from a representative AK lesion selected at screening. If the biopsy result for a patient revealed a residual AK, the patient was considered “not cleared” for the analysis irrespectively of the investigator’s clinical assessment."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS) 6 patients (1 BF-200 ALA and 5 Placebo patients) had a missing evaluation of the second biopsy 12 weeks after PDT.||percentage of participants||95% Confidence Interval|Number
11993|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)||percentage of participants||95% Confidence Interval|Number
11994|NCT01966068|Primary|Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use|Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.|Up to 6 Months|Analysis population included every subject (parent/guardian) who logged on to the MyAsthma Web Portal at least once.||participants|||Number
11995|NCT01966042|Secondary|Functional Change Evaluation|Analysis of objective improvement in myocardial ischemia (in %), by stress technetium scintigraphy.|Baseline, 6 and 12 months|||percentage of area change||Standard Deviation|Median
11996|NCT01966042|Other Pre-specified|Life Quality|"Analysis of the variation in life quality questionnaire - Short Form Health Survey (SF-36) was performed. Each domain of the questionnaire was evaluated as a quantitative variable and the medians were retrieved before and after the procedure.~The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.~It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.~One patient was lost before answering the questionnaire post procedure."|Baseline and 12 months|||units on a scale||Standard Deviation|Median
11997|NCT01966042|Secondary|Functional Change Evaluation|Analysis of Left Ventricular Ejection Fraction (in %), by echocardiogram.|Baseline and 12 months|||percentage of Left Ventrical Ejection||Standard Deviation|Median
11998|NCT01966042|Primary|Angina Class Variation|"It was evaluated in accordance with the percentage of participants that change the functional class of angina according to CCSAC (Canadian Cardiovascular Society Angina Classification - description below), after treatment. The functional class of angina was also analyzed as an ordinal variable and the median of the functional class was calculated before and after the procedure, at the time of interest (3, 6 and 12 months post treatment), in comparison to baseline, ie. value at 3 months minus value at baseline.~Screening of Functional Graduation of Stable Angina:~I - Angina only occurs after a fast or prolonged and strenuous effort during work or recreation.~II - Slight limitation to everyday activities. III - Considerable limitation of common physical activity. IV - Inability to perform any physical activity without discomfort, the symptoms can be present at rest."|3, 6 and 12 months|||Angina Classification||Standard Deviation|Median
11999|NCT01965938|Secondary|Alternate Device Used||<100 seconds|||number times an alternate device used|||Number
12000|NCT01965938|Other Pre-specified|Oropharyngeal Injuries|Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.|24 hours|||participants|||Number
12001|NCT01965938|Secondary|Lowest Pulse Oximetry Saturation Value Reading During Intubation|Lowest pulse oximetry saturation value reading collected from any participant during intubation|<100 seconds|||percentage of saturated hemoglobin|||Number
12002|NCT01965938|Secondary|Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist|Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc|<100 seconds|||participants|||Number
12003|NCT01965938|Secondary|Grade of Glottic View|According to McCormack and Lehane|<100 seconds|data was not collected|||||
12004|NCT01965938|Secondary|Number of Attempts Performed During Airway Management||<100 seconds|||number attempts||Standard Deviation|Mean
12005|NCT01965938|Secondary|Number of Participants With Successful Intubation|Successful intubation defined as confirming tube placement by the presence of etCO2;|<100 seconds|||participants|||Number
12006|NCT01965938|Primary|Time Until Proper Endotracheal Tube Placement|Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.|usually <100 seconds|||seconds||Inter-Quartile Range|Median
12007|NCT01965899|Secondary|Survey of the Patient Experience Over Time|"To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device over 1 month, 6 month, and 12 month follow-up visit."|12 months|"There were 149 patient surveys from 150 1-month follow-up visits collected, 145 surveys from 147 6-month visits, and 143 surveys from 144 12-month visits. Thus, 437 surveys were collected from 441 follow-up visits. The question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device was answered 434 times."||Percentage of surveys|Participants||Number
12008|NCT01965899|Secondary|Survey of the Implanting Physicians|"To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question Overall, how would you rate the ease of entire implant procedure?."|Day of implant|"There have been 151 implant procedures in the study, and 151 physician implant surveys were collected. Of these 151 surveys, 149 answered the question Overall, how would you rate the ease of entire implant procedure?."||Percentage of surveys|||Number
12009|NCT01965899|Secondary|Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor|To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive.|48 hours|A Holter recording was performed in all 150 patients (one patient exited before 1 month), of which 141 were suitable for analysis after excluding recordings with technical issues, such as loss of telemetry or inability to process the data.||Percentage of patients|||Number
12010|NCT01965899|Secondary|Safety Endpoint|To characterize the system-related and procedure-related adverse events.|12 months|||Number of events|||Number
12011|NCT01965899|Secondary|Accuracy of Reveal LINQ Device Detected Atrial Fibrillation|To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.|4 months|||Episodes|Participants||Number
12012|NCT01965899|Primary|R-wave Amplitudes Greater Than or Equal to 200 μV|The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.||Percentage of subjects|||Number
12013|NCT01965899|Primary|R-wave Amplitude|To characterize the signal quality of the R-wave amplitude at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.||μV||Standard Deviation|Mean
12014|NCT01965899|Primary|Success of Wireless Transmissions|To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.|30 days|All 151 subjects received a CareLink monitor software update. Subjects contributed 4,511 follow-up days in their first 30 days.||percentage of successful transmissions|Participants|95% Confidence Interval|Number
12015|NCT01965665|Primary|Change in Sepsis Rate|Patients will be assessed weekly for sepsis or until frame is removed.|weekly from baseline until frame removal, up to 16 weeks|Data not collected|||||
12016|NCT01965665|Primary|Number of Patients With Pin Site Infection|Patients will be assessed weekly for pin site infection up until frame removal.|weekly from baseline until frame removal, up to 16 weeks|||participants|||Number
12017|NCT01965665|Primary|Total Number of Pin Sites|total number of pin sites for all patients enrolled|Day of surgical intervention approximately 3hrs.|||total number of pin sites|||Number
12018|NCT01965600|Secondary|Time to Cmax (Tmax) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.|||||
12019|NCT01965600|Secondary|Area Under the Concentration-time Profile From Time 0 to End of Dosing Interval, Tau (AUCtau) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.|||||
12020|NCT01965600|Secondary|Maximum Plasma Concentration (Cmax) of PF-06282999||Day 3|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
12021|NCT01965600|Secondary|Peak (AUC0.5-2hours and AUC0-2hours) of MPO Activity/MPO Mass|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
12022|NCT01965600|Secondary|Concentrations of TNF-alpha, IL-1 Beta, IL-6, IL-8, and hsCRP|The effect of multiple oral doses of PF-06282999 on inflammatory biomarkers was a secondary objective in this study. The biomarkers are tumor necrosis factor (TNF)-alpha, interleukin (IL)-1 beta, IL-6, IL-8, and high-sensitivity C-reactive protein (hsCRP).|Days 1, 3, and 4|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
12023|NCT01965600|Primary|Number of Participants With Abnormal Urinary Biomarker Values|Urinary biomarkers included albumin, neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin-C.|Days 1-3 prior to dosing with PF-06282999/Placebo; and Days 4-5|Analysis not done due to early termination of study.|||||
12036|NCT01965535|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
12067|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12024|NCT01965600|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the ECG Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval >=500 msec; QT corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec, and >=500 msec, or an increase of 30 to <60 msec or >=60 msec. Due to early termination of the study, only ECG data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening; Days 1-5 and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.||participants|||Number
12025|NCT01965600|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change (increase [inc] or decrease [dec]) in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change (inc or dec) in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate (PR) of <40 or more than (>)120 beats per minute (bpm); and standing PR of <40 or >140 bpm. Due to early termination of the study, only vital signs data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening and Days 1-2, 4-5, and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 for orthostatic (orth) measurements; Day 3 for supine measurements|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings. n=number of participants evaluable for that parameter||participants|||Number
12026|NCT01965600|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). Due to early termination of the study, only laboratory data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Baseline up to 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.||participants|||Number
12027|NCT01965600|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as newly occurring AEs or those worsening after first dose. Due to early termination of the study, only AE data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months)|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.||participants|||Number
12028|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0 to 2 Hours [AUC0-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
12029|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0.5 to 2 Hours [AUC0.5-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
12030|NCT01965600|Primary|Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.|||||
12031|NCT01965561|Secondary|Pain During Tourniquet Application|Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.|1 minute|||mm on VAS||Standard Deviation|Mean
12032|NCT01965561|Primary|Effectiveness at Stopping Distal Pulse|Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.|1 min|||percentage of participants|||Number
12033|NCT01965535|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
12037|NCT01965535|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.~1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.~1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set)."|Posttreatment Week 12|Full Analysis Set: participant with genotype 1 HCV infection who were randomized and received at least 1 dose of active study drug.||percentage of participants|||Number
12038|NCT01965431|Secondary|Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)||bpm||Standard Error|Mean
12039|NCT01965431|Secondary|Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)||bpm||Standard Error|Mean
12040|NCT01965431|Secondary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment|"Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated.~QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. ‘Baseline’ denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1|ECG analysis set (ECGS)||ms||Standard Error|Mean
12041|NCT01965431|Primary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|"Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated.~QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. ‘Baseline’ denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|Electrocardiogram (ECG) analysis set (ECGS): all subjects in the treated set who had at least 1 baseline and post-baseline assessment for at least 1 ECG endpoint.||ms||Standard Error|Mean
12042|NCT01965327|Secondary|Change in Total Friedreich Ataxia Rating Scale (FARS) Score|The Friedreich Ataxia Rating Scale (FARS) is neurological rating scale specifically developed and validated for FRDA. The FARS includes assessments of stance, gait, upper and lower limb coordination, speech, proprioception and strength. In addition to the standard neurological examination, the FARS contains three quantitative performance measures and a component that assesses activities of daily living (ADL). Quantitative performance measures include the nine-hole peg test, and a timed 25-foot walk. FARS scores correlate significantly with functional disability, activities of daily living scores and disease duration. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|FARS score was calculated at the beginning and conclusion of treatment (baseline and 12 weeks)|The analysis was based on an intent-to-treat approach and included all subjects with baseline FARS assessment.||units on a scale||Standard Deviation|Mean
12043|NCT01965327|Primary|Change in Whole Blood Frataxin Levels|Assessment of the change in whole blood frataxin levels as assessed by lateral flow assay using an immunoassay for frataxin. Frataxin levels in the blood were measured at each study visit. Change in frataxin level at the end of treatment (week 12) relative to frataxin level at baseline was analyzed.|Frataxin levels were measured at the beginning and conclusion of treatment (baseline and 12 weeks)|The primary analysis was based on an intent-to-treat approach including all subjects who had baseline frataxin blood levels collected.||percentage of baseline frataxin level||Standard Deviation|Mean
12044|NCT01965288|Secondary|Participant Preference for Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; first study lenses, second study lenses, neither)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.||percentage of participants|||Number
12045|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.||percentage of participants|||Number
12046|NCT01965288|Secondary|Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.|"Percentage of participants that answer the question, How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues? Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|8 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12047|NCT01965288|Secondary|Participant Recommendation of a Study Lens to Friends, Family or Colleagues|"Percentage of participants that answer the question, What study lens they will most likely recommend to friends, family or colleagues? Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)"|8 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
14194|NCT01924975|Secondary|A Comparison Will be Made Between Groups for Overall Success Rate Within 3 Attempt of Needle Insertions or a 10 Minute Time Period, Whichever Comes First.||10 minutes||||||
12048|NCT01965288|Secondary|Participants Likelihood of Continuing to Wear the Study Lenses.|"Participants likelihood of continuing to wear either of the pairs of study lenses when asked; How likely are they to continue to wearing either the first study lenses or the second study lenses? Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12049|NCT01965288|Secondary|Participants Likelihood of Switching From Habitual Lenses to the Study Lenses|"Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses? Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of particpants|||Number
12050|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of participants|||Number
12051|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of participants|||Number
12052|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of patients|||Number
12053|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.||percentage of patients|||Number
12054|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12055|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12056|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12057|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12058|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12059|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12060|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12061|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12062|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12063|NCT01965288|Secondary|Corneal Neovascularization|Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12064|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12065|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12066|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12068|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12069|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12070|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12071|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12072|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12073|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12074|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of eyes|Participants||Number
12075|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12076|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12077|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12078|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12079|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12080|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12081|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
12082|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
12083|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12084|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12085|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12086|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12087|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
12088|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
12110|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12089|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|4 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
12090|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|2 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
12091|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|4 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
12092|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|2 weeks|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
12093|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA).~Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|4 Weeks|All 60 subjects randomized to both sets of lenses.||logMAR||Standard Deviation|Log Mean
12094|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA).~Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|2 Weeks|All 60 subjects randomized to both sets of lenses.||logMAR||Standard Deviation|Log Mean
12095|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
12096|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
12097|NCT01965288|Primary|Wavefront Aberrations RMS (3mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
12098|NCT01965288|Primary|Wavefront Aberrations Root Mean Square (RMS) (3mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.||microns|Participants|Standard Deviation|Mean
12099|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12100|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12101|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12102|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12103|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12104|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12105|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12106|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12107|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12108|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12109|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12112|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12113|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12114|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12115|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12116|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12117|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12118|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12119|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|4 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12120|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|2 weeks|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12121|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)|4 Weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12122|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)|2 Weeks|All 60 subjects randomized to both sets of lenses.||percentage of participants|||Number
12123|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|4 weeks|All 60 subjects randomized to both sets of lenses.||hours||Standard Deviation|Mean
12124|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|2 weeks|All 60 subjects randomized to both sets of lenses.||hours||Standard Deviation|Mean
12125|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses fitted|Participants||Number
12126|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|Dispense|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
12127|NCT01965288|Primary|Lens Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12128|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12129|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12130|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12131|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)|Dispense|All 60 subjects randomized to both sets of lenses.||degrees|Participants|Standard Deviation|Mean
12132|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale|Participants|Standard Deviation|Mean
12133|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12134|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)|Dispense|All 60 subjects randomized to both sets of lenses.||percentage of lenses|Participants||Number
12135|NCT01965288|Primary|Visual Acuity logMAR|Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).|Dispense|All 60 subjects randomized to both sets of lenses.||logMAR|Participants|Standard Deviation|Log Mean
12136|NCT01965288|Primary|Vision Stability Upon Contact Lens Insertion|Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12137|NCT01965288|Primary|Vision Quality With Contact Lens Prescription|Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12138|NCT01965288|Primary|Vision Satisfaction Upon Contact Lens Insertion|Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12139|NCT01965288|Primary|Comfort Upon Contact Lens Insertion|Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)|Dispense|All 60 subjects randomized to both sets of lenses.||units on a scale||Standard Deviation|Mean
12140|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
12141|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
12142|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
12143|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
12144|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
12145|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline|||percentage of participants|||Number
12146|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline|||percentage of participants|||Number
12147|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline|||percentage of subjects|||Number
12148|NCT01965288|Primary|Vision Stability Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|Baseline|||units on a scale||Standard Deviation|Mean
12149|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day|Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Baseline|||units on a scale||Standard Deviation|Mean
12150|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|Baseline|||units on a scale||Standard Deviation|Mean
12151|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|||percentage of eyes|Participants||Number
12152|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)|Baseline|||hours||Standard Deviation|Mean
12153|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.||units on a scale||Standard Deviation|Mean
12154|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12155|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12156|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12157|NCT01965262|Primary|Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12158|NCT01965262|Primary|Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12159|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12160|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12161|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12162|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12163|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12164|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.|Baseline|7 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12165|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.||Eyes|Participants||Number
12166|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens movement measurements were obtained at baseline.||Eyes|Participants||Number
12167|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.||Eyes|Participants||Number
12168|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at baseline.||Eyes|Participants||Number
12169|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|1 week|11 subjects discontinued the study.||Eyes|Participants||Number
12170|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|Baseline|All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at baseline.||Eyes|Participants||Number
12171|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|1 week|11 subjects discontinued the study.||Eyes|Participants||Number
12172|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|Baseline|All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at baseline.||Eyes|Participants||Number
12173|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|1 week|11 subjects discontinued the study.||participants|||Number
12174|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|Baseline|All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at baseline.||participants|||Number
12633|NCT01954160|Secondary|24-hour Urine Sodium Excretion|Difference in 24-hour urine sodium excretion, compared between pre-RSD and 13 weeks after RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12175|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|1 week|11 subjects discontinued the study.||participants|||Number
12176|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|Baseline|All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at baseline.||participants|||Number
12177|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|1 week|11 subjects discontinued the study.||participants|||Number
12178|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|Baseline|All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline.||participants|||Number
12179|NCT01965262|Primary|Biomicroscopy - Hema-copolymer and Etafilcon A|Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).|1 week|11 subjects discontinued the study.||units on a scale||Standard Deviation|Mean
12180|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.||logMAR||Standard Deviation|Mean
12181|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.|Baseline|All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.||logMAR||Standard Deviation|Mean
12182|NCT01965067|Secondary|Heart Rate|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, Heart rate at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery|||beats/min||Standard Deviation|Mean
12183|NCT01965067|Secondary|Mean Arterial Blood Pressure|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, mean arterial blood pressure at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery|||mmHg||Standard Deviation|Mean
12184|NCT01965067|Other Pre-specified|Adverse Events|adverse effect of sugammadex(hypersensitivity, dry mouth, hypertension etc.)|During 7days after operation|||participants|||Number
12185|NCT01965067|Other Pre-specified|Post-operative Nausea and Vomiting||During 7days after operation|||participants|||Number
12186|NCT01965067|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 1day after operation|||participants|||Number
12187|NCT01965067|Primary|Reversal Time of Rocuronium|The time from the administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition.|The recovery time to the TOF ratio of 0.9 after the administration of the sugammadex, an expected average of 5 minutes|||seconds||Standard Deviation|Mean
12188|NCT01964898|Secondary|Negative Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months|||units on a scale||Standard Error|Mean
12189|NCT01964898|Secondary|Positive Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance|Baseline to 6 months|||units on a scale||Standard Error|Mean
12190|NCT01964898|Secondary|Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)|The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months|||units on a scale||Standard Error|Mean
12191|NCT01964898|Secondary|Depression: 9 Item Patient Health Questionnaire (PHQ-9)|The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months|||units on a scale||Standard Error|Mean
12192|NCT01964898|Primary|Time to Smoking Lapse|Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||Days||Standard Error|Mean
12193|NCT01964898|Primary|Time to Smoking Relapse|Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||Days||Standard Error|Mean
12194|NCT01964898|Primary|Continuous Abstinence From Smoking Since Discharge|Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||proportion of participants||95% Confidence Interval|Number
12195|NCT01964898|Primary|Smoking Cessation: 7 Day Point Prevalence Abstinence|No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months|||proportion of participants||95% Confidence Interval|Number
26170|NCT01664975|Primary|Progression-free Survival||up to end of follow-up-phase (approximately 24 months)|||participants|||Number
12196|NCT01964716|Secondary|Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here “n”= participants evaluable =specified category.|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.||titer||95% Confidence Interval|Geometric Mean
12197|NCT01964716|Secondary|Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here “n”= Number of participants with an antibody titer ≥ LLOQ for the given serotype.|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.||percentage of participants||95% Confidence Interval|Number
12198|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under ‘Screened Only’ arm.|Informed consent up to Dose 1|Safety population: participants who received at least 1 dose of study vaccine. Here “N”= participants evaluable for this outcome measure.||participants|||Number
12199|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state|Dose 1 up to 28 to 42 days after dose 3|Safety population included all participants who received at least 1 dose of study vaccine.||participants|||Number
12200|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.||participants|||Number
12201|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.||participants|||Number
12202|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 1 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.||participants|||Number
12203|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.||participants|||Number
12204|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days and 'n' = participants whose response was “Yes” for any day or “No” for all days for specified local reaction.||participants|||Number
12205|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 1(Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.||participants|||Number
12206|NCT01964716|Primary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group|Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here “n”= participants with valid and determinate IgG concentration to the given serotype.|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
12207|NCT01964716|Primary|Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here “n”= participants with valid and determinate IgG concentration to the given serotype.|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
12208|NCT01964547|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of subjects who experienced an adverse event during the course of the study is presented.|0-50 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
12209|NCT01964547|Secondary|Change From Baseline to End of Treatment in Timed 10-meter Walk Times.|Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||seconds||Standard Deviation|Mean
12210|NCT01964547|Secondary|The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.|"Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation Without Intent, Active Suicidal Ideation With Intent, No Plan, Active Suicidal Ideation With Intent and Plan. The number of patients with a treatment-emergent flag is presented."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
12211|NCT01964547|Secondary|Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.|At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||visits||Standard Deviation|Mean
12634|NCT01954160|Secondary|Urine Volume|Urine volume following furosemide therapy after sodium loading.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12212|NCT01964547|Secondary|Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.|All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
12213|NCT01964547|Secondary|Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Physicians were asked the following question to be rated on a seven-point scale:~How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
12214|NCT01964547|Secondary|Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Caregivers were asked the following question to be rated on a seven-point scale:~How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
12215|NCT01964547|Secondary|Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.|"Patients were asked the following question, to be rated on a seven-point scale:~Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below.~The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||participants|||Number
12216|NCT01964547|Secondary|Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.|The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
12217|NCT01964547|Primary|Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
12218|NCT01964352|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
12219|NCT01964352|Secondary|TDI Focal Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS||Units on a scale||Standard Error|Mean
12220|NCT01964352|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
12240|NCT01963676|Secondary|Persistence of Decrease in AHRS Score Over Time|We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.|Day 5, One month|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.||units on a scale||Standard Deviation|Mean
12221|NCT01964352|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS||units on a scale||Standard Error|Mean
12222|NCT01964352|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS||L||Standard Error|Mean
12223|NCT01964352|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints. The patient that entered the study with two different patient numbers was excluded from the FAS.||L||Standard Error|Mean
12224|NCT01964326|Secondary|"Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled Stop Use and Ask a Doctor Symptoms"|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The “Stop use and ask a doctor” symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days’ timeframe.|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who experienced any of the labeled Stop use and ask a doctor symptoms."||Percentage of participants||95% Confidence Interval|Number
12225|NCT01964326|Secondary|"Percentage of Participants Taking an Ask a Doctor or Pharmacist Before Use Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication"|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. ‘Ask a doctor or pharmacist before use’ medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who reported the use of any Ask a doctor or pharmacist before use medication."||Percentage of participants||95% Confidence Interval|Number
12226|NCT01964326|Primary|Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.|Day 1 up to Week 26|The analysis was performed on continuing users who checked their LDL-C during the study.||Percentage of participants||95% Confidence Interval|Number
12227|NCT01964326|Primary|Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.|Day 1 up to Week 26|The analysis was performed on the continuing users set which is a subset of the users set, defined as the users who continued taking the study medication for at least 6 weeks since the first date of the study treatment.||Percentage of participants||95% Confidence Interval|Number
12228|NCT01964222|Secondary|Attitudes About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported intent.||units on a scale of 1 to 5||Standard Deviation|Mean
12229|NCT01964222|Primary|Uncertainty in Choice|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall “uncertainty” score from 0 to 100. Higher values represent more uncertainty. Participation in study concludes upon completion of questionnaire.|1 day Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated uncertainty.||units on a scale of 0 to 100||Standard Deviation|Mean
12230|NCT01964222|Primary|Clarity of Values|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall “values clarity” score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated values clarity.||units on a scale of 0 to 100||Standard Deviation|Mean
12231|NCT01964222|Secondary|Self-efficacy for Communicating About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported self-efficacy for finding information about cancer clinical trials.||units on a scale of 1 to 5||Standard Deviation|Mean
12232|NCT01964222|Primary|Knowledge About Cancer Clinical Trials|"A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as Only very sick patients are asked to take part in a cancer research study and Cancer research studies almost never involve the use of a placebo or sugar pill alone. Participants will indicate each item as True, False, or I don't know. An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire."|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of percentage of knowledge questions answered correctly.||percentage questions answered correctly||Standard Deviation|Mean
12233|NCT01963845|Secondary|HOMA-IR, Homeostatic Model Assessment of Insulin Resistance|HOMA-IR, calculated as [(glucose (mg/dL) X insulin (mg/dL)) / 405 ] at baseline and 24 weeks|Baseline and 24 weeks|All participants with HOMA-IR calculated at baseline and 24 weeks||HOMA-IR score||Inter-Quartile Range|Median
12234|NCT01963845|Secondary|LDL, Low-density Lipoprotein|LDL, measured in mg/dL at baseline and 24 weeks|Baseline and 24 weeks|All participants with LDL measurements at baseline and 24 weeks||mg/dL||Inter-Quartile Range|Median
12235|NCT01963845|Secondary|ALT, Alanine Aminotransferase|ALT, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with ALT measurements at baseline and 24 weeks||IU/L||Inter-Quartile Range|Median
12236|NCT01963845|Secondary|AST, Aspartate Aminotransferase|AST, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with AST measurements at baseline and 24 weeks||IU/L||Inter-Quartile Range|Median
12237|NCT01963845|Primary|Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF|Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.|Baseline and 24 weeks|||percentage change in liver fat||Standard Deviation|Mean
12238|NCT01963767|Secondary|Cognitive Performance|The secondary endpoint will be improvement in cognitive performance over the two-month follow-up period on the paper and pencil tests of cognitive ability. The test that was used here is the Identical Pictures test, from the Educational Testing Services battery (Ekstrom RB, French JW, Harman HH, Dermen D. Manual for kit of factor referenced cognitive tests. Educational Testing Service, Princeton, NJ, 1976.). This test evaluates the number of pictures that persons can match within a 90 second period. There are two trials at 90 seconds and the maximum score is 48 matches (minimum is 0). Higher scores indicate better performance because participants are able to make more matches within the 90 second interval. This test provides an index of processing speed, the ability to do a task rapidly.|Measured at baseline and two months|||units on a scale||Standard Error|Mean
12239|NCT01963767|Primary|Delay Eyeblink Conditioning|"Participants will be tested on eyeblink classical conditioning at the USF Health Byrd Alzheimer's Institute. Participants will receive 60 trials of eyeblink conditioning at the two-month follow-up point. Participants watch an entertaining silent video (e.g., Milo and Otis). The airpuff is delivered through a nozzle held in front of the participant and blink latency is recorded.~The outcome measure is an index of the percentage of eyeblinks that are made to a tone (conditioned stimulus) after the learning period is complete. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned; Woodruff-Pak, D. S. (2001). Eyeblink classical conditioning differentiates normal aging from Alzheimer's disease. Integrative Physiological and Behavioral Science, 36(2), 87-108.)."|Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses|From the 105 persons with complete data on the second outcome, only 102 had complete data on this outcome. The three who did not contribute to this analysis were because there were two equipment failures and one person had a glass eye and the procedure could not be performed.||percentage of conditioned responses||Standard Deviation|Mean
14195|NCT01924975|Primary|The Primary Object is to Compare the First Attempt Success Rate Between Ultrasound Group and Landmark Group for Saphenous Vein Cannulation.||10 minutes|||percentage of participants|||Number
12241|NCT01963676|Primary|Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5|Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.|Baseline, Day 5|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.||units on a scale||Standard Deviation|Mean
12242|NCT01963611|Secondary|Mean Change From Baseline in Brain Volume Per Subject|Change from baseline in brain volume per subject was calculated using 5 series MRI scan.|Baseline, Weeks 24, 28, 32, 36, 40|The Outcome Measure was not derived due to early termination of the study.|||||
12243|NCT01963611|Secondary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|The Outcome Measure was not derived due to early termination of the study.|||||
12244|NCT01963611|Secondary|Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||cubic millimeter (mm^3)||Standard Deviation|Mean
12245|NCT01963611|Secondary|Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||cubic millimeter (mm^3)||Standard Deviation|Mean
12246|NCT01963611|Secondary|Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan|New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.|Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||lesions/subject/scan||Standard Deviation|Mean
12247|NCT01963611|Secondary|Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan|New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36,40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||lesions/subject/scan||Standard Deviation|Mean
12248|NCT01963611|Secondary|Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36, 40|"ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||lesions/subject/scan||Standard Deviation|Mean
12249|NCT01963611|Secondary|Percentage of Subjects Remaining Relapse-Free|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).||percent subjects|||Number
12250|NCT01963611|Secondary|Mean Annualized Relapse Rate (ARR)|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).||percent relapse||Standard Deviation|Mean
12251|NCT01963611|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.|Baseline , Week 12, 24, 28, 32, 36, 40|Intent to Treat (ITT) analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.||lesions per subjects per scan||Standard Deviation|Mean
12252|NCT01963091|Secondary|Likert Scale Rating of Subjective Craving|Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'|0 mintues post 15 minute stress task|||units on a scale||Standard Deviation|Mean
12253|NCT01963091|Secondary|Likert Scale Rating of Subjective Stress|Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'|0 minutes post 15 minute stress task|||units on a scale||Standard Deviation|Mean
12254|NCT01963091|Primary|Salivary Cortisol Levels|salivary cortisol|0 minutes post 15 minute stress task|||mg/dl||Standard Deviation|Mean
12255|NCT01962961|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Measure of endothelial function|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.||Percentage of vessel diameter||Standard Deviation|Mean
12256|NCT01962961|Primary|Change in Circulating F2-isoprostane Levels|Oxidative stress measure|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.||pg/mL||Standard Deviation|Mean
12257|NCT01962961|Primary|Change in Circulating Malondialdehyde Levels|Measure of oxidative stress|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.||micromolar||Standard Deviation|Mean
12258|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the Protocol PK population N= 46 was used.||ng/mL||Standard Deviation|Mean
12259|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measuure the Protocol PK population of N = 46 was used.||ng/mL||Standard Deviation|Mean
12260|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the PK population N=46 was used.||ng*hr/mL||Standard Deviation|Mean
12261|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours"|Day 14|For this outcome measuure the Protocol PK population N= 46 was used.||ng/mL||Standard Deviation|Mean
12262|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measuure the Protocol PK population of N = 46 was used.||ng/mL||Standard Deviation|Mean
12263|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measure the PK population N=46 was used||ng*hr/mL||Standard Deviation|Mean
12264|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the Protocol PK population N= 46 was used.||ng/mL||Standard Deviation|Mean
12265|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measuure the Protocol PK population of N = 46 was used.||ng/mL||Standard Deviation|Mean
12266|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the PK population N=46 was used.||ng*hr/mL||Standard Deviation|Mean
12267|NCT01962675|Secondary|Change From Baseline Score on Toe Tap Test|Measuring the Time required to perform toe taps|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
12268|NCT01962675|Secondary|Change From Baseline Scores of a 10 m Walk Test|Change from baseline score of the time required to perform 10 m walking.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
12269|NCT01962675|Primary|Change From Baseline Active Motor Threshold|Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
12270|NCT01962675|Primary|Change From Baseline Midswing Ankle ROM|Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.|||||
12279|NCT01962441|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
12271|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12272|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12273|NCT01962493|Secondary|Overall Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12274|NCT01962493|Secondary|Overall Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12275|NCT01962493|Secondary|Overall Facial MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12276|NCT01962493|Secondary|Overall Facial MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12277|NCT01962493|Secondary|Overall MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12278|NCT01962493|Primary|Modified Lobene Stain Index (MLSI) at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.||Score on a Scale||Standard Deviation|Mean
12280|NCT01962441|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
12281|NCT01962441|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
12282|NCT01962441|Secondary|HCV RNA at Weeks 1, 2, 4, 8, and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
12283|NCT01962441|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Full Analysis Set||percentage of participants|||Number
12284|NCT01962441|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
12285|NCT01962441|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
12286|NCT01962441|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
12287|NCT01962428|Secondary|Bleeding Events||follow-up for 28 days after the loading dose of ticagrelor||||||
12288|NCT01962428|Secondary|Platelet Reactivity Index (PRI) Measured by VASP-P||0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor||||||
12289|NCT01962428|Primary|Platelet Reactivity Index(PRI) Measured by VASP-P|Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).|2 hours after the loading dose of ticagrelor|||percentage of 100||Inter-Quartile Range|Median
12290|NCT01961544|Secondary|Disease Control Rate (DCR)|DCR is defined as the number of participants with complete response (CR), partial response (PR), and stable disease (SD). The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess the tumor response. Tumor response was evaluated by investigators. CR is defined as the disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]. The SLD must also demonstrate an absolute increase of at least 5 mm. [Two lesions increasing from 2 mm to 3 mm, for example, does not qualify]).|mean of 3.76 months|Full Analysis Set: participants who were administered investigational product at least once after enrollment and had at least one primary efficacy data value since Baseline||Participants|||Number
12291|NCT01961544|Primary|Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)|An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.|mean of 3.76 months|Safety Set: all participants who are administered investigational product at least once for the analysis||Participants|||Number
12292|NCT01961349|Primary|Achivement of Target Sedation|The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.|from scope-in to scope-out|FAS (Full Analysis Set)||% of patients||95% Confidence Interval|Number
12293|NCT01961349|Secondary|PSSI Total Score|PSSI (Statistics of Patient Satisfaction with Sedation Instrument) total score obtained from 20 questions (1 to 7 points for each) adjusted to have range of 0 ( very dissatisfied: all items scored with 1 point) to 100 (very satisfied: all items scored with 7 points)|at 24-48 h after endoscopy|FAS (Full Analysis Set)||Score on a scale (0 - 100)||Standard Deviation|Mean
12294|NCT01961271|Secondary|Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.||From time of enrolment to Visit 6 (ie. up to119 days from enrolment)|||participants|||Number
12295|NCT01961271|Secondary|Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)|||units on a scale||Standard Deviation|Mean
12296|NCT01961271|Secondary|Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication|Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries.|Approximately 17 weeks starting from enrolment|||participants|||Number
12297|NCT01961271|Secondary|Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE|Side effects of the transdermal patch treatment will be analysed.|From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)|||participants|||Number
12298|NCT01961271|Secondary|Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention|"Pre-intervention: Visit 1 Post-intervention: Visit 6~There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here:~Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed"|approximately 17 weeks starting from enrolment|||percentage of subjects|||Number
12299|NCT01961271|Primary|Efficacy According to BS-11 Pain Score Reduction|"The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score.~BS-11 is known as Box scale-11; it is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Maximum 17 weeks starting from enrolment|Subjects of the analysis population met the eligibility criteria. It consists of subjects who completed the study and who withdrew for any reason.||units on a scale||Standard Deviation|Mean
12300|NCT01960907|Post-Hoc|Difference of Hospitalization Rate|Difference between the hospitalization rate during the study and the previous year. For each patient, hospitalization rate was defined as the number of hospital admissions during a period divided by the length (in days) of the period. Number of hospitalizations was collected by the hospital clinical records.|Baseline and 9 months|||hospitalizations/year/patient||Inter-Quartile Range|Median
12301|NCT01960907|Primary|Final Utility Index of EQ-5D Questionnaire|The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life.|9 months|An intention to treat analysis has been applied for the primary outcomes of the trial. Multiple Imputation (MI) was used to assign values were data were missing. However for a limited number of patient, due to the fact that all data were missing, we couldn't apply any imputation method and therefore they have been excluded.||units on a scale||Standard Deviation|Mean
12302|NCT01960907|Primary|Time to First Hospitalization|It represents the number of days, since the enrolment into the study, to the first hospitalization|From enrolment up to 9 months|An intention to treat analysis has been applied for the primary outcomes of the trial and all the randomized patients have been retained for the analysis.||days||Inter-Quartile Range|Mean
12303|NCT01960842|Other Pre-specified|Physical Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for physical examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)||||||
12304|NCT01960842|Other Pre-specified|Neurological Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for neurological examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)||||||
12305|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG)|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), QT interval corrected for heart rate using Fridericia's formula (QTcF), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively. n = the number of participants with available data at each time point.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
12306|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
12307|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f), males (m), and femtoliters (fL).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
12308|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), body temperature (Temp), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.||participants|||Number
12309|NCT01960842|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs (TEAEs) are defined as any event that began or worsened in severity after N-J placement. The investigator assessed the relationship of each event to the use of study drug as Reasonable Possibility or No Reasonable Possibility.~For more details on adverse events please see the AE section below."|From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.|Safety Analysis Set: All subjects who had undergone the N-J placement procedure.||participants|||Number
12635|NCT01954160|Primary|Urine Sodium Excretion|Within-subject comparison of increase in urine sodium excretion following saline loading before RSD and 13 weeks following RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected, endpoints not measured|||||
12310|NCT01960842|Secondary|Average Daily Normalized “Off” Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. n= the number of participants with available data at each time point."|Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12|All participants in the FAS with available data.||hours||Standard Deviation|Mean
12311|NCT01960842|Secondary|Average Daily Normalized “Off” Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
12312|NCT01960842|Secondary|Average Daily Normalized “Off” Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
12313|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0 to 23 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
12314|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0 to 16 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
12315|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0 to176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline and Final PEG-J Visit (up to Week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
12316|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items (each question answered on a 5-point scale) addressing 8 domains of health in Parkinson's disease patients: Mobility (e.g., fear of falling when walking) includes 10 questions; Emotional Well-being (e.g., feelings of isolation) includes 6 questions; Stigma (e.g., social embarrassment) includes 4 questions; Social Support includes 3 questions; Cognition includes 4 questions; Communication includes 3 questions; and Bodily Discomfort includes 3 questions. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
12317|NCT01960842|Secondary|"Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
12318|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
12649|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
12319|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
12320|NCT01960842|Secondary|Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit|"The PGI-C is a 7-point response scale. The subjects were to rate their change in status from Screening Visit 1 using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. The responses of Minimally improved, Much improved, and Very much improved on the PGI-C were used to define responders."|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||units on a scale||Standard Deviation|Mean
12321|NCT01960842|Secondary|Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit|The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||units on a scale||Standard Deviation|Mean
12322|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.||units on a scale||Standard Deviation|Mean
12323|NCT01960842|Secondary|"Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.||hours||Standard Deviation|Mean
12324|NCT01960842|Primary|Average Daily Normalized “Off” Time: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the Full Analysis Set (FAS; all enrolled participants who received at least 1 dose of LCIG infusion during the PEG-J Period and had data for baseline and at least 1 post-PEG-J efficacy assessment) with available data.||hours||Standard Deviation|Mean
12325|NCT01960816|Post-Hoc|NOSE Score at 90-day Follow-up|The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity. Each subject's NOSE score at the 90-day follow-up was compared to that subject's baseline NOSE score to determine change in nasal obstruction symptoms.|90 days|Subjects with 90-day follow-up data||units on a scale||Standard Deviation|Mean
12326|NCT01960816|Primary|Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue|Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.|Procedure, up to 1 hour (average, 16 minutes)|All enrolled subjects underwent the procedure.||participants|||Number
12327|NCT01960816|Primary|Incidence of Unanticipated Serious Adverse Device Effects|The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)|90 Days|One subject was lost-to-follow-up prior to the 90-day follow-up visit. Therefore, 32 subjects were available for analysis at the 90-day time point.||events|||Number
12328|NCT01960400|Secondary|State Anxiety|The State-Trait Anxiety Inventory (STAI) was used to assess the state of anxiety at the moment (Spielberg et al., 1983). The total score is obtained by adding the scores for all 20 questions range from 20 to 80; the higher the result is, the higher is the anxiety about an event.|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
12329|NCT01960400|Secondary|Kinesiophobia|The Tampa Scale of kinesiophobia (TSK) (Kori et al., 1990) was used to assess fear of movement and injury/(re)injury. The TSK questionnaires consist of 17 items. Each item, composed of a statement, is scored by the patient on a 4-point Likert scale of 1 (strongly disagree) to 4 (strongly agree). The total scores range from 17 to 68, with higher scores representing stronger fear-avoidance beliefs (Clark, Kori, Brockel, 1996).|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
12370|NCT01959412|Secondary|Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.|Day 1 (12 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||liters||Standard Error|Least Squares Mean
12330|NCT01960400|Secondary|Pain Catastrophizing|"The Pain catastrophizing scale (PCS) (Sullivan et al., 1995) was used to evaluate the feelings, thoughts, and emotions related to pain catastrophizing of the patient. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness.~* The scores ranging from 0 to 52 points (sum of the tree subscales), with higher scores representing stronger pain catastrophizing (Sullivan et al., 1995)."|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
12331|NCT01960400|Primary|Pain Severity|"The choice of outcome measures was performed in accordance with Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) guidelines (Dworkin et al., 2005). All instruments were used before (T0) and after 6 weeks of treatment (T1).~The primary outcome measure was pain severity as measured with the Brief pain inventory short-form (BPI-sf) (Poundja et al., 2007). The BPI-sf includes four questions on pain levels, where subjects were asked to rate intensity on a scale of 0 (no pain) to 10 (worst possible pain) for: (1) pain at its worst in the last 24 hours; (2) pain at its least in the last 24 hours; (3) pain on average in the last 24 hours; (4) pain right now. The total score ranges from 0 to 40 (sum of the four subscales). The higher the score, the greater the severity of the pain is severe."|Before (T0) and after treatment (6 weeks) (T1)|||units on a scale||Standard Deviation|Mean
12332|NCT01960387|Secondary|Predictive Factors for Response to Treatment.|Evaluation of potential factors that are predictive of clinical response in newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 1 year|Results data are not available due to low/insufficient subject accrual from early [trial] termination.|||||
12333|NCT01960387|Secondary|Relapse Free Survival|Number of months of relapse free survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.|||||
12334|NCT01960387|Secondary|Overall Survival|Number of months of survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.|||||
12335|NCT01960387|Primary|Complete Clinical Response|Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10^9/l, a platelet count greater than or equal to 100 x 10^9/l, and no evidence of extramedullary disease.|Between 14 and 28 days from start of study treatment|Newly diagnosed Acute Myeloid Leukemia patients who received clofarabine (1-2 hour intravenous infusion of 40mg/m2 daily dose) plus cytarabine (2-4 hours maximum intravenous infusion of 1g/m2 daily dose) starting 3-4 hours post completion of clofarabine administration on days 1 through 5, who were evaluable for response by bone marrow biopsy.||participants|||Number
12336|NCT01960114|Secondary|Patient Global Evaluation|Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent.|12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||percentage of participants|||Number
12337|NCT01960114|Secondary|Duration of Pain Relief|Minutes until rescue medication was given.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||Minutes||95% Confidence Interval|Median
12338|NCT01960114|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||Minutes||95% Confidence Interval|Median
12339|NCT01960114|Secondary|Time to Confirmed First Perceptible Pain Relief|Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||Minutes||95% Confidence Interval|Median
12340|NCT01960114|Primary|Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)|Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.|10 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.||units on a scale||Standard Error|Least Squares Mean
12341|NCT01959945|Secondary|Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.||percentage of participants||95% Confidence Interval|Number
12342|NCT01959945|Secondary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.||percentage of participants||95% Confidence Interval|Number
12343|NCT01959945|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.|Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.||titer||95% Confidence Interval|Geometric Mean
12344|NCT01959945|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.|Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.|Day 0 up to Day 28 post vaccination|||participants|||Number
12345|NCT01959932|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
12346|NCT01959932|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
12347|NCT01959932|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."||ng/mg creat||95% Confidence Interval|Least Squares Mean
12348|NCT01959932|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."||pg/mg creat||95% Confidence Interval|Least Squares Mean
12349|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
12350|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
12351|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
12352|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
12353|NCT01959685|Primary|Cmax of a Single Dose of 250 mg Androxal||24 hours|Safety population||ng/dL||Standard Deviation|Mean
12354|NCT01959685|Primary|Pharmacokinetics|Cmax of a single dose 125 mg of Androxal|24 hrs|Safety population||ng/dL||Standard Deviation|Mean
12355|NCT01959607|Primary|Ratio of the Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2 and CC (Group 1)|"Based on the primary outcome, only the ratio THS 2.2:CC is presented.~The ratio THS 2.2:CC of AUC(0-last) takes into consideration the blood measurements taken at both Day 1 (THS 2.2) and Day 3 (CC) for the sequence THS 2.2 then CC, and Day 1 (CC) and Day 3 (THS 2.2) for the sequence CC then THS 2.2."|Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use)|"The primary outcome was analyzed using Group 1.~Group 1 consisted of 42 subjects: 21 subjects in the sequence THS 2.2 then CC and 21 subjects in the sequence CC then THS 2.2."||percentage of [ng*h/mL]||95% Confidence Interval|Least Squares Mean
12406|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
12356|NCT01959607|Primary|Ratio of the Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2 and CC (Group 1)|"Based on the primary outcome, only the ratio THS 2.2:CC is presented.~The ratio THS 2.2:CC of Cmax takes into consideration the blood measurements taken at both Day 1 (THS 2.2) and Day 3 (CC) for the sequence THS 2.2 then CC, and Day 1 (CC) and Day 3 (THS 2.2) for the sequence CC then THS 2.2."|Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use)|"The primary outcome was analyzed using Group 1.~Group 1 consisted of 42 subjects: 21 subjects in the sequence THS 2.2 then CC and 21 subjects in the sequence CC then THS 2.2."||percentage of [ng/mL]||95% Confidence Interval|Least Squares Mean
12357|NCT01959516|Secondary|Comparison of Glycopyrronium QD Versus Tiotropium QD on Symptoms Outcome|"Comparison of symptoms outcome between glycopyrronium QD versus tiotropium QD will be conducted via the PROMorning COPD Symptoms questionnaire. This questionnaire will be completed by participants at waking-up, pre-inhalation of study treatment (at home), and they will complete Part 2 of PRO-Morning COPD Symptoms questionnaire at site, 3hours post-inhalation of study treatment. The PRO-Morning COPD Symptoms Questionnaire is a self-administered patient reported outcome (PRO) instrument developed by the sponsor to evaluate patients' experience of early morning symptoms of COPD. The questionnaire consists of two parts : predose and postdose.~Each part has 6 questions and for each question a scale of 0 to 10 can be reached. For the predose and postdose part of the questionnaire you will have then each a total score of 0-60 by adding the sub-scores for each question, higher scores represent worse severity of COPD morning symptoms"|day 1 (baseline) and week 4|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1||Scores on a scale||95% Confidence Interval|Least Squares Mean
12358|NCT01959516|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-4h After First Dose of Treatment.|Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) will measured via spirometry and calculated from 0 to 4 hours post-dose on day 1 of study treatment.|Day 1|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1||Liters*hours||95% Confidence Interval|Least Squares Mean
12359|NCT01959503|Secondary|Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days||30 days post procedure|One subject in Progel Vascular Sealant and one subject in Gelfoam Plus discontinue before 30days and do not have device-related SAE. They are considered as not evaluable and are not included in this analysis, thus makes the difference compared to population in baseline.||participants|||Number
12360|NCT01959503|Secondary|Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.||30 days post procedure|||participants|||Number
12361|NCT01959503|Secondary|Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.||Intra-procedurally|In the Vascular group two subjects were not evaluable as information was not collected for this endpoint, which changes the number from 106 to 104, compare to baseline characteristics.||minutes||Standard Deviation|Mean
12362|NCT01959503|Secondary|Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.||participants|||Number
12363|NCT01959503|Secondary|Chest Tube Drainage Volume Following Surgery.||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.||mL||Standard Deviation|Mean
12364|NCT01959503|Secondary|Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||0 seconds to 10 minutes|||percentage of participants|||Number
12365|NCT01959503|Secondary|Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||5 minutes after application|In the Progel group one subject was not evaluable as information was not collected for this endpoint, which change the number from 106 to 105, compare to baseline characteristics.||percentage of participants|||Number
12366|NCT01959503|Primary|Time to Achieve Hemostasis at the Aortic Anastomotic Suture Line From the Time Surgical Clamps Are Released to Cessation of Leakage at the Treated Anastomotic Site With Either Progel or Gelfoam.||0 seconds to 600 seconds|In the Progel group one subject was not evaluable as information was not collected for the primary end-point changing the number from 106 to 105, compare to baseline characteristics.||seconds||Standard Deviation|Mean
12367|NCT01959412|Secondary|Change From Period Baseline in FVC (L) AUC (0-24h)|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
12368|NCT01959412|Secondary|Change From Period Baseline in Trough FEV1 (L)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
12369|NCT01959412|Secondary|Change From Period Baseline in Peak FEV1 (L)|Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
12371|NCT01959412|Primary|Change From Period Baseline in FEV1 (L) AUC(0-24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.|Day 1 (24 hours)|drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables||Liters||Standard Error|Least Squares Mean
12372|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.|Week 12|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 12, the analysis for the number of patients categorised as sexually dysfunctional was based on the 82 patients who had a measure for this outcome||participants|||Number
12373|NCT01959035|Secondary|Change From Baseline to Week 12 in ASEX Total Score|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for ASEX total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12374|NCT01959035|Secondary|Change From Baseline to Week 12 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for WoRQ total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12375|NCT01959035|Secondary|Change From Baseline to Week 12 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for TooL total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12376|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Instrumental Role' QLS domain score was based on the 81 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12377|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Interpersonal Relations' QLS domain score was based on the 82 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12392|NCT01959035|Secondary|Change From Baseline to Week 24 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for CGI-S score was based on the 78 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12378|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 82 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12379|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Common Objects and Activities' QLS domain score was based on the 82 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12380|NCT01959035|Secondary|Change From Baseline to Week 12 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for QLS total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12381|NCT01959035|Secondary|Change From Baseline to Week 12 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for CGI-S score was based on the 83 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12382|NCT01959035|Secondary|Change From Baseline to Week 12 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for SWN-S total score was based on the 82 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12383|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.|Week 24|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 24, the analysis for the number of patients categorised as sexually dysfunctional was based on the 75 patients who had a measure for this outcome||participants|||Number
12384|NCT01959035|Secondary|Change From Baseline to Week 24 in ASEX Total Score|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for ASEX total score was based on the 75 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12425|NCT01958619|Primary|OZ439 Cmax|OZ439 observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12385|NCT01959035|Secondary|Change From Baseline to Week 24 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for WoRQ total score was based on the 77 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12386|NCT01959035|Secondary|Change From Baseline to Week 24 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for TooL total score was based on the 75 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12387|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Instrumental Role' QLS domain score was based on the 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12388|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Interpersonal Relations' QLS domain score was based on the 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12389|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12390|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Common Objects and Activities' QLS domain score was based 78 patients who had a measure for this outcome||units on a scale||Standard Deviation|Mean
12391|NCT01959035|Secondary|Change From Baseline to Week 24 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for QLS total score was based on the 78 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12393|NCT01959035|Secondary|Change From Baseline to Week 24 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for SWN-S total score was based on the 75 patients who had a measure for this outcome||units on a scale||95% Confidence Interval|Least Squares Mean
12394|NCT01959035|Primary|Safety and Tolerability|Number of treatment emergent adverse events (TEAEs).|Up to 24 weeks and 4-week safety follow up|Safety data is based on all patients who received at least one dose of investigational medicinal product (IMP) in Study 14724B.||number of events|||Number
12395|NCT01958827|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.~For more details on adverse events please see the AE section below."|60 weeks|Safety Analysis Set||participants|||Number
12396|NCT01958827|Secondary|Body Temperature: Mean Change From Baseline (Week 0) to Each Visit|n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||degrees Celcius||Standard Deviation|Mean
12397|NCT01958827|Secondary|Heart Rate: Mean Change From Baseline (Week 0) to Each Visit|Heart rate was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||bpm||Standard Deviation|Mean
12398|NCT01958827|Secondary|Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||mm Hg||Standard Deviation|Mean
12399|NCT01958827|Secondary|Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set||mm Hg||Standard Deviation|Mean
12400|NCT01958827|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters|Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|52 weeks|Safety Analysis Set||participants|||Number
12401|NCT01958827|Secondary|Number of Participants With Potentially Significant Hematology Parameters|Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. Increase is signified by ↑. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value.|52 weeks|Safety Analysis Set: All enrolled participants who received at least one dose of study drug.||participants|||Number
12402|NCT01958827|Other Pre-specified|Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Baseline (Week 0) to Week 52|FAS||participants|||Number
12403|NCT01958827|Other Pre-specified|Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method. The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha. n=the number of participants with available data at each time point.|Baseline (Week 0) to Week 52|All participants in the FAS with available data at both time points.||µg/mL||Standard Deviation|Mean
12404|NCT01958827|Secondary|C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||mg/dL||Standard Deviation|Mean
12405|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
12426|NCT01958346|Secondary|Sore Throat Grade on First Postoperative Day|Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe|Postoperative day one|||participants|||Number
12407|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. Week 8 was the primary outcome measure.|Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
12408|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS||percentage of participants||95% Confidence Interval|Number
12409|NCT01958827|Primary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Week 8|Full Analysis Set (FAS): All enrolled participants who received at least one dose of study drug and had at least one post-treatment efficacy assessment.||percentage of participants||95% Confidence Interval|Number
12410|NCT01958788|Secondary|Beck Depression Inventory, 2nd Edition (BDI-II)|The BDI-II is a self-report questionnaire assessing a variety of depressive symptoms, including low mood, anhedonia, and worthlessness. Scores range from 0 to 63, with greater scores indicating greater depressive symptoms. The BDI-II was used to evaluate change from baseline in self-reported depressive symptoms.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
12411|NCT01958788|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self-report questionnaire assessing affective, cognitive, and somatic anxiety over the preceding week. Scores range from 0 to 63, with greater scores representing greater self-reported anxiety. The BAI was used to evaluate change from baseline in self-reported anxiety.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
12412|NCT01958788|Secondary|GAD Safety Behaviours Questionnaire (GAD-SBQ)|The GAD-SBQ is a self-report questionnaire assessing the tendency to use safety behaviours to cope with anxiety, such as reassurance-seeking and overpreparation. Scores range from 18 to 90, with greater scores indicating greater use of safety behaviours. The GA-SBQ was used to evaluate change from baseline in self-reported safety behaviours.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
12413|NCT01958788|Secondary|Penn State Worry Questionnaire (PSWQ)|The PSWQ is a self-report questionnaire assessing excessive and uncontrollable worry. Scores range from 16 to 80, with greater scores indicating greater worry. The PSWQ was used to evaluate change from baseline in self-reported worry.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
12414|NCT01958788|Secondary|Intolerance of Uncertainty Scale (IUS)|The IUS is a self-report questionnaire assessing intolerance of uncertainty, or the tendency to view uncertainty and its consequences as negative. Scores range from 27 to 135, with higher scores representing greater intolerance of uncertainty. The IUS was used to assess change from baseline in self-reported intolerance of uncertainty.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
12415|NCT01958788|Secondary|Worry and Anxiety Questionnaire (WAQ)|The WAQ is a questionnaire assessing self-reported symptoms of GAD. Scores range from 0 to 56, with higher scores indicating greater severity of self-rated GAD symptoms. The measure was used to assess change from baseline in self-reported GAD symptoms (WAQ).|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
12416|NCT01958788|Primary|Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)|The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up|||units on a scale||Standard Deviation|Mean
12417|NCT01958645|Secondary|Change From Baseline D-dimer Concentration||predose and 1-8 hours|||mg/L||Standard Deviation|Mean
12418|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by Clot Assay||Predose and 1-8 hours|||% (concentration)||Standard Deviation|Mean
12419|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by ECL Assay||Predose and 1-8 hours|||umol/L||Standard Deviation|Mean
12420|NCT01958645|Secondary|Change From Baseline Endogenous Thrombin Potential (ETP)|For the baseline variables and adverse events the two placebo arms (placebo dose 1 and placebo dose 2) are recorded as one. For the secondary outcome measures the two placebo arms are recorded separately.|Predose and Days 1-5|||nM*min||Standard Deviation|Mean
12421|NCT01958645|Primary|Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination||From screening and up to the lab follow-up visit (Day 29)|||Participants|||Number
12422|NCT01958619|Secondary|Piperaquine AUC0-∞|Piperaquine Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12423|NCT01958619|Secondary|Piperaquine Cmax|Piperaquine Observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12424|NCT01958619|Primary|OZ439 AUC0-∞|OZ439 Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12428|NCT01958164|Secondary|Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.|This endpoint was defined as the number of doses required to achieve restored CVAD function in patients from the actilyse treatment group but was analysed as the percentage of participants who achieved restored CVAD function after 1 dose and 2 doses, in patients from the actilyse treatment group.|0 minutes and 240 minutes|All patients in the FAS who were randomised to the Actilyse treatment group||percentage of participants|||Number
12429|NCT01958164|Secondary|Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0)|240 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration||percentage of participants||95% Confidence Interval|Number
12430|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0)|150 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration||percentage of participants||95% Confidence Interval|Number
12431|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0|Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution)|30 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
12432|NCT01958164|Primary|Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication|Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).|120 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
12433|NCT01958060|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS)||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
12434|NCT01958060|Secondary|AUC0-inf|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).~AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial."|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS):||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
12435|NCT01958060|Secondary|Cmax|Maximum measured concentration of BI 1034020 in plasma (Cmax).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic Set (PKS): This subject set included all subjects in the treated set who provide at least 1 observation for at least 1 secondary Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
12436|NCT01958060|Primary|Percentage of Subjects With Drug Related Adverse Events|Percentage of subjects with investigator defined drug-related adverse events|from the first drug administration to end of trial, up to 50 days|Treated Set (TS)||percentage of participants|||Number
12437|NCT01958008|Secondary|R(A,AUC)|R(A,AUC) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||ratio||Geometric Coefficient of Variation|Geometric Mean
12438|NCT01958008|Secondary|R(A,Cmax)|R(A,Cmax) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||ratio||Geometric Coefficient of Variation|Geometric Mean
12439|NCT01958008|Secondary|T1/2,ss|T1/2,ss (terminal half life of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||hours||Geometric Coefficient of Variation|Geometric Mean
12440|NCT01958008|Secondary|Tmax,ss|Tmax,ss (time from last dosing to maximum concentration of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||hours||Full Range|Median
12441|NCT01958008|Secondary|AUC Tau,ss|AUC tau,ss (area under the concentration-time curve of the BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
12552|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)|Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
12442|NCT01958008|Secondary|Cmax,ss|Cmax,ss (maximum measured concentration of BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|Pharmacokinetic set (PKS): The patient set for the evaluation of PK endpoints included all evaluable patients in the treated set which provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
12443|NCT01958008|Primary|Number (%) of Patients With Drug-related Adverse Events (AEs)|Number (%) of patients with drug-related adverse events (AEs)|AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)|Treated set (TS)||percentage of participants|||Number
12444|NCT01957930|Secondary|Microvascular Endothelial Function|Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response.|2 months||11/2015||||
12445|NCT01957930|Primary|Ischemic Foot Ulcer|The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code|Until hospitalization for ischemic foot ulcer or until 31 December 2011|||participants|||Number
12446|NCT01957865|Secondary|HIV RNA Suppression|HIV RNA suppression (<100 copies/ml) was compared by study arms with Fisher’s exact test.|After month 9|Note: missing data equals lack of suppression||number of participants|||Number
12447|NCT01957865|Primary|Antiretroviral Therapy (ART) Adherence Levels|Difference in ART adherence among the study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.|real time (for 9 months)|||Percent adherence||Standard Deviation|Mean
12448|NCT01957761|Primary|Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis|Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.|On day 1 of diagnosis of Clostridium difficile infection|||cases of BI/NAP1/027|||Number
12449|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12450|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12451|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12452|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12453|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12582|NCT01955044|Secondary|Resolvin Levels|Resolvin, a metabolite of LCPUFA, will be measured at 8 weeks of life.|8 weeks of life||09/2016||||
12583|NCT01955044|Secondary|LCPUFA Levels|LCPUFA levels will be measured at 8 weeks of life.|8 weeks of life|||wt% (g/100g)||Inter-Quartile Range|Median
12454|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12455|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12456|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12457|NCT01957657|Secondary|Number (%) of Subjects With Drug-related Adverse Events|Number (percentage) of subjects with drug-related adverse events|From the first drug administration until last drug administration, up to 10 days|Treated set (TS) included all enrolled subjects, who had taken at least one dose of trial medication.||percentage of participants|||Number
12458|NCT01957657|Primary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined|||||
12459|NCT01957657|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.|||||
12460|NCT01957553|Primary|Preference|The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.|21+1 days|The ITT population was constituted by all randomized subjects with valid informed consent who had applied at least one test product and had valid information for the primary endpoint preference, or valid information for at least one product with respect to one of the secondary endpoints., who included all subject who contributed with endpoint data||percentage of participants|||Number
12461|NCT01957488|Primary|Leakage|The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14 +- 1 days|||percentage of baseplates|Participants||Number
12462|NCT01957475|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome).~The degree of leakage was measured at each baseplate change."|14 days|||units on a scale|Participants|Standard Deviation|Mean
12463|NCT01957462|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome).~The degree of leakage is measured at each baseplate change"|14 days|||units on a scale|Participants|Standard Deviation|Mean
12464|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1|MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles. The Motor Evoked Response to Transcranial Magnetic Stimulation (TMS MEPs) was evaluated at baseline and regularly after study drug administration. Intracortical inhibition and facilitation was also evaluated using TMS. A figure-of-eight coil with external loop diameters of 9 cm was used to elicit motor responses in the contralateral first dorsal interosseus.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of MEP.||mV||Standard Deviation|Mean
12465|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1|SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 64-channel EEG system at baseline (predose) and regularly after study drug administration. The change from baseline was calculated as post-baseline value minus baseline value for each participant. Since the number of participants at baseline differ from the number of participants at post-baseline measure (that is [i.e.] not all baseline values are paired), the mean change is not equal to the difference between the means at the two time points.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of SEP (P40).||millivolts (mV)||Standard Deviation|Mean
12466|NCT01957397|Primary|Degree of Leakage|The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)|14 days|||units on a scale|Participants|Standard Deviation|Mean
12467|NCT01957384|Primary|Degree of Leakage|The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S|Up to 14 days per test product|||units on a scale|Participants|Standard Deviation|Mean
12468|NCT01957215|Secondary|Total Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Dose||Full Range|Median
12469|NCT01957215|Secondary|Time to First Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Days||95% Confidence Interval|Median
12470|NCT01957215|Secondary|Rate of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Number of participants|||Number
12471|NCT01957215|Secondary|Patients' Global Assessment to Treatment|Patients global assessment in response to treatment was measured at the end of the study on a scale of 0 to 4 where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
12472|NCT01957215|Secondary|Total Pain Relief (TOTPAR) on Movement|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, baseline), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (time t – time t-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Mean
12473|NCT01957215|Secondary|Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement|"SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point.~SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time; 0 hr (Day 1, pre treatment), 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr, respectively.~PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [based on NRS which is a horizontal line with a scale from 0-10. where 0 represents “No” and 10 represents the “worst possible pain”]. NR scores were converted into PID scores by subtracting them from baseline pain scores.~PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]"|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
12474|NCT01957215|Secondary|Assessment of Sum of Pain Intensity Difference (SPID) on Movement|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).~Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents “No” and 10 represents the “worst possible pain”."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
12475|NCT01957215|Secondary|Time to Onset of Pain Relief|"Time to onset of pain relief was measured by the time to reach a pain relief score of 1 (“A little or perceptible pain relief”)."|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Days||Full Range|Median
12496|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Number of participants|||Number
12476|NCT01957215|Secondary|Change From Baseline in NRS at Rest|Mean changes in pain intensity at each time point at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups at time points 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs was measured using NRS. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), participants were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
12477|NCT01957215|Secondary|NRS for Pain on Movement Over Time|"NRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.~The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), patients were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain."|30 mins to 144 hr post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Deviation|Mean
12478|NCT01957215|Secondary|Pain Relief Score (PRS) on Movement Over Time|"PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.~Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score."|30 minutes (mins) to 144 hours (hrs) post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.||Score on scale||Standard Deviation|Mean
12479|NCT01957215|Primary|Sum of Pain Intensity Difference (SPID)1-3 Days|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).~Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents “No” and 10 represents the “worst possible pain”"|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on the Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement||Score on scale||Standard Error|Least Squares Mean
12480|NCT01957202|Secondary|Weighted Mean of the Total Ocular Symptom Score (TOSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes , each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes). TOSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TOSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|PD Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
12481|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Ocular Symptom Score (TOSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TOSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes).|Day 1 of each treatment period (up to 80 days)|PD Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
12482|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Nasal Symptom Score (TNSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TNSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]).|Day 1 of each treatment period (up to 80 days)|PD Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
12497|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Number of participants|||Number
12584|NCT01955044|Primary|Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels|LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants|2 weeks of life|2 subjects died prior to having 2 week levels drawn, from causes unrelated to study.||weight % (g/100g)||Inter-Quartile Range|Median
12483|NCT01957202|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of investigational product) and who also provided data from at least one PD assessment. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
12484|NCT01957163|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
12485|NCT01957163|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
12486|NCT01957111|Secondary|Sleep Efficiency Percentage on Overnight Sleep Study|Participants will have their sleep measured with polysomnography for one night. The sleep of individuals with insomnia will be compared to that of good sleepers. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed.|1 night|||% sleep efficiency||Standard Deviation|Mean
12487|NCT01957111|Primary|Number of Metabolites Elevated Relative to the Other Group.|Metabolomics analysis of blood samples were carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. A total of 70 metabolites were measured and compared between individuals with insomnia and good sleepers.|48 hours|||Number of metabolites elevated|||Number
12488|NCT01956240|Secondary|Scapular Kinematics After Pectoralis Minor Stretching Protocol|The scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.|6 weeks of stretching|||degree||Standard Deviation|Mean
12489|NCT01956240|Primary|Pectoralis Minor Length After Pectoralis Minor Stretching Protocol|The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.|6 weeks after stretching|||centimeters||Standard Deviation|Mean
12490|NCT01956097|Secondary|Number of Participants With Adverse Events||8th weeks|"6 participants in the HX106 590mg group and 2 participant in the HX106 1180mg were dropped out."||number of participants|||Number
12491|NCT01956097|Secondary|Number of Participants With Adverse Events||4th weeks|"3 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."||number of participants|||Number
12492|NCT01956097|Secondary|Number of Participants With Adverse Events||1st week|"2 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."||number of participants|||Number
12493|NCT01956097|Primary|Changes From Baseline in White Matter Integrity Assessment||Baseline, 8th weeks||||||
12494|NCT01956097|Primary|Changes From Baseline in Working Memory Domain Z-score|"To assess the working memory performance, four well-established tests, including the symbol span from the Wechsler Memory Scale-IV, immediate recall domain from the Rey-Osterrieth Complex Figure Test, digit span, and letter number sequencing from the Korean version of the Wechsler Adult Intelligence Scale were chosen.~Each test score was adjusted with age, sex, intelligent quotient, years of education, and baseline test scores. The adjusted test scores were then standardized into z-scores using all participants' means and standard deviations. The relative improvement (positive z-scores) or decline (negative z-scores) in performance was measured in a unit-free manner using the obtained z-scores. The individual z-scores of each test were averaged to the composite score for working memory domain."|Baseline, 8th week|||z-score||Standard Error|Mean
12495|NCT01956032|Secondary|Median Time Spent for Health Care Utilization Outside the TM Care Chain|The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Minutes||Full Range|Median
12498|NCT01956032|Secondary|Percentage of Participants With Clinical Global Impression – Improvement (CGI-I) in Parkinson’s Disease Symptoms|CGI-I was used to document the Investigator’s impression of the participant’s improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12499|NCT01956032|Secondary|DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12500|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12501|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12502|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12503|NCT01956032|Secondary|Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘yes’ or ‘no’ for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12504|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12505|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12506|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12507|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12508|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12509|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12510|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12511|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12551|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)|Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
12512|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12513|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as ‘yes’ or ‘no’ for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12514|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident’ and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12515|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as ‘yes’ or ‘no’ for question number 14 (Where you able to perform daily activities during the titration period?) where ‘yes’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12516|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant’s Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant’s home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12517|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as ‘yes’ or ‘no’ for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12518|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure’ and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12650|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
12519|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident’ and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12520|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician’s Visits to Set up and Dismantle the TM Equipment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician’s visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12521|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12522|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12523|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12524|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12525|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12651|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
12652|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
12526|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12527|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as ‘yes’ or ‘no’ for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where ‘yes’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12528|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.||Percentage of participants|||Number
12529|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of technical events|||Number
12530|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12531|NCT01956032|Secondary|Incidence of Consequences Due to Technical Events|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of consequences|||Number
12532|NCT01956032|Secondary|Percentage of Participants With Consequences|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12533|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of technical events|||Number
12534|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Percentage of participants|||Number
12535|NCT01956032|Secondary|Median Total Free Time of Participant|Participant’s daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant’s daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant’s total free time was calculated as the sum of participant’s daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Minutes||Full Range|Median
12536|NCT01956032|Secondary|Median Total Time for Titration|The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator’s decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Minutes||Full Range|Median
12537|NCT01956032|Primary|Median Number of Contacts|Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.||Number of contacts||Full Range|Median
12538|NCT01956032|Primary|Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant|Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using full analysis set (FAS), defined as all participants that started Duodopa titration.||Minutes||Full Range|Median
12539|NCT01955720|Secondary|Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)|"Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h).~PK Urine sampling time:~Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h."|from 0 to 6 hours of post Ida dose (details in description)|PKS-Ida: The PKS-Ida included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.||umol||Geometric Coefficient of Variation|Geometric Mean
12540|NCT01955720|Secondary|Cmax (Maximum Measured Concentration of the Ida in Plasma)|"Cmax. PK/PD sampling time: (p=predose, D=day)~single medium or high dose, HS mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.~single low or high dose, healthy elderly or mild RI: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8: 9:00;D9: 9:00.~high 2 doses, moderate RI: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8:9:00; D9:9:00."|From Ida administration to 4 days post dose (details in description)|PKS-Ida||nmol/L||Geometric Coefficient of Variation|Geometric Mean
12541|NCT01955720|Secondary|Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)|"Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state.~PK Urine sampling time:~Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.~Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years."|From 0 to 74h post of last DE dose (details in description)|Pharmacokinetic Set - DE (PKS-DE): The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.||μg||Geometric Coefficient of Variation|Geometric Mean
12653|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
12542|NCT01955720|Secondary|AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)|"PK/PD sampling time:(d=dose,D=Day,p=predose)~single medium or high dose,healthy, mid-age (45-64 yrs): D4: 7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00, 01:00; D5:9:00p,11:00,21:00p; D6:9:00p, 21:00p; D7:9:00p, 11:00.~single low or high dose,healthy elder or mild renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00;D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.~high 2 doses, moderate renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,9:55p,10:00,10:10,10:30,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00; D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00."|from 2h to12h of post DE dose at steady state (details in description)|PKS-DE: The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12543|NCT01955720|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC0-infinity. PK/PD sampling time: (p=predose, D=day)~single medium or high dose, healthy subjects(HS) mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.~single low or high dose, HS elderly or mild renal impaired: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8: 9:00;D9: 9:00.~high 2 doses, moderate renal impaired: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8:9:00; D9:9:00."|From Day 4 to Day 9 (details in description)|Pharmacokinetic Set -Ida (PKS-Ida): included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
12544|NCT01955720|Primary|The Percentage of Subjects With Drug-related Adverse Events|The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.|From baseline up to the start of follow-up period (from Day 1 to Day 35)|Treated Set (TS): All randomised subjects who received at least 1 dose of trial medication were included in the treated set.||percentage of participants|||Number
12545|NCT01955720|Primary|Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time|Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.|End of last infusion and 10 minutes after completion of last infusion of BI 655075|PD Set (PDS): The PDS included all subjects from the TS who had at least 1 evaluable predose and on-treatment coagulation test measurement value for at least 1 coagulation test and who did not have important protocol violation relevant to the evaluation of PD.||percentage of participants|||Number
12546|NCT01955707|Secondary|Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment.|Up to Day 90 ± 5 days|Safety population (all participants who were randomized and received any portion of the infusion of study treatment).||participants|||Number
12547|NCT01955707|Secondary|Barthel Index at Day 5, Day 30, and Day 90|The Barthel Index consists of 10 items that measure a person’s daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessment at given time point.||units on a scale||Full Range|Median
12548|NCT01955707|Secondary|Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90|The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment), using imputed data; n=number of participants with an assessment at given time point.||participants|||Number
12549|NCT01955707|Secondary|Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death.|Baseline, 24 hours, Day 5, Day 30, Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessments at Baseline and given time point.||units on a scale||Standard Deviation|Mean
12550|NCT01955707|Secondary|Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)|Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth.|Day 5, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
12553|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
12554|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, 24 hrs|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
12555|NCT01955707|Primary|Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.||mL||Inter-Quartile Range|Geometric Mean
12556|NCT01955629|Secondary|Part 2: Aflibercept Biomarkers Evaluation|Blood and tumor samples were to be collected to evaluate proteomic biomarkers such as factors and receptors related to angiogenesis process, inflammation, and tumor progression.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned biomarker analyses was performed.|||||
12557|NCT01955629|Secondary|Part 2: Pharmacodynamic Parameters: Modulation of Circulating Analytes|Blood and tumor samples were to be collected to evaluate the pharmacodynamic parameters including the assessment of the modulation of circulating analytes such as cytokines and angiogenic factors.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned efficacy/pharmacodynamic analyses was performed.|||||
12558|NCT01955629|Secondary|Part 2: Number of Participants With CR or PR|Tumor assessment was performed by abdomino-pelvic computed tomography scan or MRI and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using RECIST version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Baseline and every 9 weeks up to end of study completion (15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
12559|NCT01955629|Secondary|Part 2: Overall Rate of Resectability of Metastatic Lesions|Overall metastases resection rate was defined as the percentage of participants reaching an R0 metastases resection, defined as the complete absence of invasive carcinoma on histological examination at the time of definitive surgery.|12 months after the last participant enrolled.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
12560|NCT01955629|Secondary|Part 2: Overall Survival (OS)|OS was defined as the time interval from the date of registration into the study to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the earliest between the last date the participant was known to be alive and the end of study date.|From the date of enrollment up to the date of death (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
12561|NCT01955629|Secondary|Part 2: Progression Free Survival (PFS)|PFS was defined as the time interval from the date of registration into the study to the date of first observation of DP or death (due to any cause), whichever was first.|From the date of enrollment up to the date of DP or death, whichever occurred first (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
12562|NCT01955629|Secondary|Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD])|Tumor assessment was performed by abdomino-pelvic computed tomography scan or magnetic resonance imaging (MRI) and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using response evaluation criteria in solid tumors (RECIST) version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; PD =20% increase in the sum of the LD of target lesions taking as reference the smallest sum in the study and SD = small changes that did not meet above criteria.|Baseline and every 9 weeks up to DP (up to 15 months).|Evaluable Population (EP) for tumor response was defined as a subset of ITT population (all participants who gave their informed consent and successfully registered into study) with measurable disease at study entry, who received at least 1 cycle of study treatment, with at least 1 post baseline tumor evaluation, except for early DP or death.||Participants|||Number
12563|NCT01955629|Primary|Part 2: Number of Participants With Progression Free Survival (PFS) at 6 Months After the Start of Maintenance Therapy|It describes the number of participants alive without progression at 6 months after the start of Aflibercept maintenance therapy.|6 months after the start of maintenance therapy.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.|||||
12585|NCT01955005|Secondary|Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.|Therapeutic duplication will be defined as concurrent use of more than one medication from the same therapeutic class. For laboratory duplication, we will review non-VA and VA medical records 6 months prior to the non-VA provider visit. Each patient will be assigned a dichotomous indicator for whether they received therapeutic duplication and/or laboratory duplication during their non-VA provider visit|Typically within 1 month of non-VA provider visit|Some veterans had their laboratories drawn prior to the medical visit and were therefore excluded from this analysis.||proportion of participants|||Number
12654|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
12564|NCT01955629|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were assessed using the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs were defined as any of following AEs: grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia associated with bleeding requiring transfusion; grade 4 non-hematological treatment related event; grade 3 nausea/vomiting or diarrhea lasting >/= 4 days despite corrective measures; grade 3 other non-hematological toxicities: anorexia, fatigue, hypertension only if G4 or not medically controlled and G3 peripheral sensory neuropathy that did not improve to G<2 at time of retreatment; urinary protein excretion of >3.5 gram per 24 hours that did not recover to <2.0 gram per 24 hours within 2 weeks; symptomatic arterial thromboembolic events including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, new onset or worsening of pre-existing angina.|Cycle 1 (Up to 3 weeks)|Evaluable DLT population defined as the subset of the whole part 1 participants that were exposed to at least 1 dose (even incomplete) of the study treatment and had a DLT assessment at Cycle 1.||Participants|||Number
12565|NCT01955369|Other Pre-specified|Gastrostomy|gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration|an average of 3 years|||participants|||Number
12566|NCT01955369|Secondary|Tracheostomy|tracheostomy in ALS patients following respiratory failure|an average of 3 years|||participants|||Number
12567|NCT01955369|Primary|Death|death of participating ALS patients independent of the cause of death|an average of 3 years|||participants|||Number
12568|NCT01955083|Post-Hoc|Percentage of Good Response After MIS|Postoperative ‘VAS <=3’ was traditionally defined as ‘major response’. For a comprehensive profile of the outcomes, we further created another definition of ‘fine response’: ‘postoperative VAS <=5 plus SOS >=60’ post hoc in the present study. Accordingly, patients with a postoperative VAS <=3 or postoperative VAS <=5 plus SOS >=60' group was considered to have a 'good response'. Therefore, we calculated the 'good response' rate in the radiofrequency and pillar implant groups.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Good Response||Standard Error|Mean
12569|NCT01955083|Secondary|Percent Change in B1-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Fmean||Standard Error|Mean
12570|NCT01955083|Secondary|Percent Change in B1-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Fpeak||Standard Error|Mean
12571|NCT01955083|Secondary|Percent Change in B1-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Imean||Standard Error|Mean
12572|NCT01955083|Secondary|Percent Change in B1-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-Imax||Standard Error|Mean
12573|NCT01955083|Secondary|Percent Change in B1-SI After MIS|Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of B1-SI||Standard Error|Mean
12574|NCT01955083|Secondary|Percent Change in Total-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Fmean||Standard Error|Mean
12575|NCT01955083|Secondary|Percent Change in Total-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Fpeak||Standard Error|Mean
12576|NCT01955083|Secondary|Percent Change in Total-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Imean||Standard Error|Mean
12577|NCT01955083|Secondary|Percent Change in Total-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-Imax||Standard Error|Mean
12578|NCT01955083|Secondary|Percent Change in Total-SI After MIS|Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.||percentage of Total-SI||Standard Error|Mean
12579|NCT01955083|Secondary|Change in SOS Score After MIS|Change in SOS score at 3 months after radiofrequency or pillar implant were calculated.|baseline and 3 months following surgery|Twenty-eight participants completed the follow-up protocol and two participants dropped out after surgery.||units on a scale||95% Confidence Interval|Mean
12580|NCT01955083|Primary|Change in VAS Score After MIS|The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement.|baseline and 3 months following surgery|Twenty-eight patients completed the protocol; two study cases were not available for follow-up. Fourteen patients underwent radiofrequency surgery and 14 patients received pillar implant surgery. Accordingly, we analyzed the participants who completed the study protocol.||units on a scale||95% Confidence Interval|Mean
12581|NCT01955044|Secondary|Resolvin Levels|resolvin, a metabolite of LCPUFA, will be measured at 2 weeks of life.|2 weeks of life||09/2016||||
12586|NCT01955005|Secondary|Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists|A medication discrepancy metric was be calculated by comparing the current VA medication list with the non-VA provider medication list to determine the total number of distinct medications. The number of discrepant medications between these lists is the numerator and is divided by the total number of distinct medications on both lists combined. This will yield a range of scores between score between 0 and 1, with 1 indicating perfect agreement between the two lists.|Typically within 1 month of non-VA provider visit|Medication reconciliation was based on Medical Record Review, therefore there was better representation of the entire sample. 2 Veterans were not included in the Internet Skills Training group because the medical records sent from the Non-VA provider were not adequate to determine an accurate medication list.||proportion of medications discrepant||Standard Deviation|Mean
12587|NCT01955005|Primary|Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider|The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.|Within 1-2 week of non-VA provider visit|This outcome was collected from the provider completed questionnaire. The reduced sample size is due to the response rate for the My Healthe Vet training group providers (74%) and the Internet Skills Training group (52%).||Percentage of Participants|||Number
12588|NCT01954745|Secondary|Median Overall Survival (OS)|To evaluate the median overall survival (OS) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||months||95% Confidence Interval|Median
12589|NCT01954745|Secondary|Objective Response Rate (ORR)|To evaluate the objective response rate (ORR) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||percent|||Number
12590|NCT01954745|Secondary|Number of Patients With Adverse Events|Evaluate the number of patients with advanced cholangiocarcinoma being treated with cabozantinib who have adverse events during treatment|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||participants|||Number
12591|NCT01954745|Primary|Median Progression Free Survival (PFS)|To evaluate the median progression free survival (PFS) of cabozantinib in patients with advanced cholangiocarcinoma after progression on 1 or 2 prior systemic therapies.|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles||months||95% Confidence Interval|Median
12592|NCT01954251|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
12593|NCT01954251|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
12594|NCT01954251|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
12595|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
12596|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
12597|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
12631|NCT01954160|Secondary|Serum Cystatin C|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12598|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
12599|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 (G3) pain = pain that prevented normal activity. Grade 3 (G3) redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.||Subjects|||Number
12600|NCT01954251|Secondary|Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer|The geometric mean ratio for Flu HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Ratio||95% Confidence Interval|Geometric Mean
12601|NCT01954251|Secondary|Number of Seroconverted Subjects in Terms of HI Antibodies|The number of seroconverted subjects was assessed in terms of HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
12602|NCT01954251|Secondary|FLU Haemagglutination Inhibition (HI) Antibody Titers|HI antibody titres against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yamma) were expressed as geometric mean titers (GMTs).|At Day 0 (PRE) and Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
12603|NCT01954251|Secondary|Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40|Seroprotection rate is defined as the percentage of vaccines with a serum HI titer ≥1:40 that usually was accepted as indicating protection. FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts(Massach)/2/2012 Yamagata (Yama).|At Day 0 (PRE) and at Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
12604|NCT01954251|Secondary|Number of Subjects With FLU HI Antibody Titers ≥1:10|FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yama). Cut-off titer for seropositivity was 1:10.|At Day 0 (PRE) and 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
12605|NCT01954251|Primary|FLU Haemagglutination Inhibition (HI) Antibody Titers|"For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain.~Adjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs."|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
12606|NCT01954251|Primary|Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies|Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.|At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
12632|NCT01954160|Secondary|Glomerular Filtration Rate|Estimated Glomerular Filtration Rate (GFR) by creatinine and cystatin C|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12607|NCT01954251|Primary|Vaccine Response for Anti-gE Humoral Immunogenicity|"The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least:~a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%."|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Percentage||95% Confidence Interval|Number
12608|NCT01954251|Primary|Number of Subjects With Vaccine Response to Anti-gE Antibodies|The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
12609|NCT01954160|Secondary|Left Ventricular End Diastolic Volume|Echo: Left Ventricular End Diastolic Volume|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12610|NCT01954160|Secondary|Tissue Doppler Indices|Echo: Tissue Doppler indices|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12611|NCT01954160|Secondary|Heart Rate Variability|Heart rate variability indices by Holter|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12612|NCT01954160|Secondary|New York Heart Association (NYHA) Functional Classification||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12613|NCT01954160|Secondary|Patient Global Assessment||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12614|NCT01954160|Secondary|Kansas City Cardiomyopathy Questionnaire Score||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12615|NCT01954160|Secondary|6 Minute Walk Test||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12616|NCT01954160|Secondary|Plasma Aldosterone||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12617|NCT01954160|Secondary|Plasma Renin Activity||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12618|NCT01954160|Secondary|Resting Urine Norepinephrine||13 Weeks following Renal Denervation||||||
12619|NCT01954160|Secondary|Resting Plasma Norepinephrine||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12620|NCT01954160|Secondary|Plasma N-terminal Pro-brain Natriuretic Peptide||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12621|NCT01954160|Secondary|Left Atrial Size|Echo: Left Atrial size|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12622|NCT01954160|Secondary|LV End Diastolic Dimension (LVEDd)|Echo: LV end diastolic dimension (LVEDd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12623|NCT01954160|Secondary|LV End Systolic Dimension (LVESd)|Echo: LV end systolic dimension (LVESd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12624|NCT01954160|Secondary|Global Longitudinal Strain|Echo: Global longitudinal strain Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12625|NCT01954160|Secondary|Left Ventricular Ejection Fraction|Echo: Left Ventricular Ejection Fraction Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12626|NCT01954160|Secondary|Left Ventricular End Systolic Volume|Echo: Left ventricular end systolic volume Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12627|NCT01954160|Secondary|Renal Resistive Index|Intra-renal hemodynamics as measured by Renal Resistive Index (RRI) by renal Doppler ultrasonography Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12628|NCT01954160|Secondary|Urine Albumin|Urine albumin|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12629|NCT01954160|Secondary|Creatinine Clearance From 24-hour Urine Creatinine|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12630|NCT01954160|Secondary|Blood Urea Nitrogen (BUN) Level|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.|||||
12636|NCT01954121|Secondary|Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From Randomization (Week 1) up to Evaluation Visit (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||events|||Number
12637|NCT01954121|Secondary|Time to First Seizure During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||events|||Number
12638|NCT01954121|Secondary|Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||events|||Number
12639|NCT01954121|Secondary|Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period||From Week 1 to Week 30|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||percentage of subjects|||Number
12640|NCT01954121|Primary|Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period||6-months Evaluation Period (From Week 4 to Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.||percentage of subjects|||Number
12641|NCT01953354|Secondary|Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added|New or increase in UC medications is defined as a need for dose-escalation of concurrent medications or need for rescue medications to treat UC through Week 16.|From Day 0 through Week 16|The Safety population included all subjects for whom study treatment was initiated.||percentage of participants|||Number
12642|NCT01953354|Secondary|Percent of Participants With Increase in Diarrhea|An increase in diarrhea is defined as an increase in the Mayo Score’s Stool Frequency score by at least 1 point from baseline at any time during follow-up.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.||percentage of participants|||Number
12643|NCT01953354|Secondary|Percent of Participants With Colonoscopic Evidence of Visible Worm|Stool evaluations for ova and parasites confirmed the absence of T. suis. If evidence suggested a presence of T. suis, a colonoscopy would be performed to confirm invasion with a visible worm.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.||percentage of participants|||Number
12644|NCT01953354|Secondary|Time to Modified Clinical Response|Number of days to reach a modified clinical response. Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed.|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects who achieved a modified clinical response are included in this analysis.||Days||Full Range|Median
12645|NCT01953354|Secondary|Percent of Participants With a Modified Clinical Response|Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with baseline and at least one post-baseline modified clinical response result are included in this analysis.||percentage of participants|||Number
12646|NCT01953354|Secondary|Percent of Participants With Healed Colonic Mucosa at Week 12|Healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with a Mayo endoscopy score at Week 12 are included in this analysis.||percentage of participants|||Number
12647|NCT01953354|Secondary|Percent of Participants Who Achieved Remission at Week 12|Remission is defined as a Mayo score of less than or equal to 1 with absence of rectal bleeding and endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with remission results at Week 12 are included in this analysis.||percentage of participants|||Number
12648|NCT01953354|Primary|Percentage of Participants Who Achieved a Clinical Response at Week 12|Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with clinical response results at Week 12 are included in this analysis.||percentage of participants|||Number
12676|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|Flow Mediated Dilation is measured as the percent change in brachial artery diameter as measured by high resolution ultrasound based on arterial diameter prior to and following 5 minute flow occlusion to the forearm . We measured the percent change in brachial diameter before vancomycin was started and again 10 days after vancomycin|Change before and after 10 days of Vancomycin, approximately 12 weeks from baseline|Subgroup analyzed who volunteered to have vancomycin||percent change||Standard Deviation|Mean
12677|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans that reports the percent change in brachial artery diameter to a flow stimulus in the arm induced by 5 minutes of occlusion of flow to the arm. It is measured as the percent change from baseline diameter.|% Change before and after 6 weeks of daily Probiotic|||percent change||Standard Deviation|Mean
12678|NCT01952691|Secondary|Adduction Angle|we aimed to see the change in hallux valgus angle during treatment.|baseline and 30th days.|||degrees|Participants|Standard Deviation|Mean
12679|NCT01952691|Secondary|FFI|We aimed to see the change in functional status with FFI (Foot function index) scale The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales used to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) that best describes the patients' foot over the past week. Patients were instructed to mark a VAS score for each question. The total score was calculated using only the questions answered.|baseline, on the 3rd, 7th, 10th and 30th days during the treatment|||units on a scale|Participants|Standard Deviation|Mean
12680|NCT01952691|Primary|Adduction Angle of Hallux With X RAY|X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping|up to 30 days after the treatment|35 feet's X Ray results were obtained from 22 patients before treatment protocol was performed.||degrees|Participants|Standard Deviation|Mean
12681|NCT01952665|Primary|Lens Preference for Handling|Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks|||participants|||Number
12682|NCT01952665|Primary|Lens Preference Comfort, Dryness, Vision and Overall.|Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks|||participants|||Number
12683|NCT01952665|Primary|Lens Preference|Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks|||participants|||Number
12684|NCT01952665|Secondary|Participant Likelihood of Recommendation of a Study Lens|Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).|4 weeks|||participants|||Number
12685|NCT01952665|Secondary|Participant Recommendation of a Study Lens|Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks|||participants|||Number
12686|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
12687|NCT01952665|Secondary|Likelihood to Continue Wearing the Study Lens|Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely|4 weeks|||participants|||Number
12688|NCT01952665|Secondary|Likelihood of Switching From Habitual Lens to Study Lens|Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely|4 weeks|||participants|||Number
12689|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|4 Weeks|||lenses|Participants||Number
12690|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|4 Weeks|||units on a scale|Participants|Standard Deviation|Mean
12691|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|4 Weeks|||units on a scale|Participants||Number
12692|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)|4 Weeks|||lenses|Participants||Number
12693|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)|4 Weeks|||lenses|Participants||Number
12694|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|4 Weeks|||units on a scale||Standard Deviation|Mean
12695|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|4 Weeks|||units on a scale||Standard Deviation|Mean
12696|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|4 Weeks|||logMAR||Standard Deviation|Mean
12697|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
14921|NCT01906658|Primary|Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication||Baseline to Week 8|||Participants|||Count of Participants
12698|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
12699|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
12700|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks|||participants|||Number
12701|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks|||participants|||Number
12702|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks|||participants|||Number
12703|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)|4 weeks|||units on a scale||Standard Deviation|Mean
12704|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|4 weeks|||units on a scale||Standard Deviation|Mean
12705|NCT01952665|Primary|Handling|Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).|4 weeks|||units on a scale||Standard Deviation|Mean
12706|NCT01952665|Primary|Dryness|Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).|4 weeks|||units on a scale||Standard Deviation|Mean
12707|NCT01952665|Primary|Comfort|Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|4 weeks|||units on a scale||Standard Deviation|Mean
12708|NCT01952665|Primary|Rewetting Drops|Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|4 weeks|||participants|||Number
12709|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 4 weeks.|4 weeks|||hours||Standard Deviation|Mean
12710|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)|4 weeks|||hours||Standard Deviation|Mean
12711|NCT01952665|Primary|Lens Preference, Pair 1 Lotrafilcon B|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )|2 weeks|||participants|||Number
12712|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|2 Weeks|||lenses|Participants||Number
12713|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|2 Weeks|||units on a scale|Participants|Standard Deviation|Mean
12714|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|2 Weeks|||lenses|Participants||Number
12715|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|2 Weeks|||lenses|Participants||Number
12716|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal|2 Weeks|||lenses|Participants||Number
12717|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|2 Weeks|||units on a scale|Participants|Standard Deviation|Mean
12718|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|2 Weeks|||units on a scale||Standard Deviation|Mean
12719|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|2 Weeks|||logMAR||Standard Deviation|Mean
12720|NCT01952665|Primary|Lens Preference, Pair 1 Comfilcon A|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)|2 weeks|||participants|||Number
12721|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
12722|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
36461|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 12 months|Number of participants assessed by EchoCG at 12 months||g||Standard Deviation|Mean
12723|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
12724|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
12725|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks|||participants|||Number
12726|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks|||participants|||Number
12727|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks|||participants|||Number
12728|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)|2 weeks|||units on a scale||Standard Deviation|Mean
12729|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|2 weeks|||units on a scale||Standard Deviation|Mean
12730|NCT01952665|Primary|Handling|Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).|2 weeks|||units on a scale||Standard Deviation|Mean
12731|NCT01952665|Primary|Dryness|Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).|2 weeks|||units on a scale||Standard Deviation|Mean
12732|NCT01952665|Primary|Comfort|Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|2 weeks|||units on a scale||Standard Deviation|Mean
12733|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)|2 weeks|||hours||Standard Deviation|Mean
12734|NCT01952665|Secondary|Rewetting Drops|Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|2 weeks|||participants|||Number
12735|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 2 Weeks.|2 weeks|||hours||Standard Deviation|Mean
12736|NCT01952665|Other Pre-specified|The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.|The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, >3)|Dispense|||number of trial lenses|Participants|Standard Deviation|Mean
12737|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)|Dispense|||units on a scale|Participants|Standard Deviation|Mean
12738|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|Dispense|||units on a scale|Participants|Standard Deviation|Mean
12739|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|Dispense|||lenses|Participants||Number
12740|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|Dispense|||lenses|Participants||Number
12741|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)|Dispense|||lenses|Participants||Number
12742|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)|Dispense|||units on a scale|Participants|Standard Deviation|Mean
12743|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|Dispense|||units on a scale|Participants|Standard Deviation|Mean
12744|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|Dispense|||logMAR||Standard Deviation|Mean
12745|NCT01952665|Primary|Visual Quality|Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)|Dispense|||units on a scale||Standard Deviation|Mean
12746|NCT01952665|Primary|Comfort at Insertion|Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).|Dispense|||units on a scale||Standard Deviation|Mean
12747|NCT01952600|Primary|Factors That Are Most Important to Patients|Differences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.|Baseline|||% of patients|||Number
12748|NCT01952366|Secondary|Cognition (as Measured With the Mini Mental State Examination (MMSE) and Clinical Diagnosis of Dementia)|One year after inclusion to the study, there will be a clinical assessment of the patient including a MMSE, if possible, and to evaluate if the patients have dementia.|1 year after inclusion to the study||11/2017||||
12750|NCT01952366|Primary|Depression|"Response (50% improvement on the Montgomery and Asberg Depression Rating Scale (MADRS) score) Remission (defined as score of 9 or less on the MADRS)~The MADRS is a measurement of the severity of depression and consists of 10 items rated from 0 points (no symptoms) to 6 (severe symptoms)"|Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)|Patients with complete MADRS records||participants|||Number
12751|NCT01952301|Primary|Keratinized Tissue Width|Change in Keratinized Tissue width|6 months|Sample size was determined using 80% power fans assuming a paired t-test of non-inferiority with a non-inferiority margin of 1.0 mm, a within-subject standard deviation of 1.0 mm, and a one-sided alpha of 0.05, resulting in a sample size of 27. To account for potential loss-to-follow-up, 30 subjects were enrolled in the trial.||mm||Standard Deviation|Mean
12752|NCT01952145|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.|During 26 weeks of treatment|The safety analysis set was used for analysis of this endpoint and this set included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”. Confirmed hypoglycaemic episodes were reported by 79 subjects in IdegLira arm and by 137 subjects in IGlar arm.||Number of episodes|||Number
12753|NCT01952145|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, week 26|FAS which included all randomised subjects was used for analysis of this endpoint. Missing values (including intermittent missing values) were imputed using LOCF method.||Kg||Standard Deviation|Mean
12754|NCT01952145|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|FAS was used for analysis of this endpoint. And FAS included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.||Percentage (%)||Standard Deviation|Mean
12755|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 16|Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Absolute change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
12756|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment|Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Absolute change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
12757|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16|Absolute change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Absolute change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
12758|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12|Absolute change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Absolute change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
12759|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 16|Percent change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Percent change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
12760|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 12|Percent change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Percent change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
12761|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 12|Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Absolute change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population||Liters/week||Standard Deviation|Mean
12762|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at Week 16|Percent change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Percent change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
12763|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment|Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Percent change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population||percent change||Standard Deviation|Mean
12764|NCT01952080|Primary|Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12|Percent change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Percent change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population (ITT), defined as all participants who were enrolled in the study.||percent change||Standard Deviation|Mean
12765|NCT01951950|Primary|Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg||1 hour postoperatively|||participants|||Number
12766|NCT01951820|Primary|Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale|The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).|2.5 minutes|||mm||Full Range|Mean
12767|NCT01951703|Primary|Subjective Overall Vision (Using CLUE )|Contact Lens User Experience Vision scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes||units on a scale||Standard Deviation|Mean
12768|NCT01951703|Primary|Subjective Overall Comfort (Using CLUE )|Contact Lens User Experience Comfort scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes||units on a scale||Standard Deviation|Mean
12769|NCT01951651|Secondary|Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)|The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline.|6 months|||percentage change from baseline||Standard Error|Mean
12770|NCT01951651|Secondary|Left Ventricular Ejection Fraction (LVEF)(%).|Left Ventricular Ejection Fraction following intervention as measured by magnetic resonance imaging in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the Left Ventricular Ejection Fraction study (magnetic resonance imaging) following 6 months of treatment||percent of Left ventricular function||Standard Error|Mean
12771|NCT01951651|Primary|Hepatic Fat Content|Hepatic fat content following intervention in patients with type 2 diabetes|6 months|One patient assigned to the glipizide treatment arm did not complete the hepatic fat content study (MRS) following 6 months of treatment||percent of hepatic fat||Standard Error|Mean
12772|NCT01951651|Primary|Myocardial Fat Content|Myocardial fat content following intervention as measured by magnetic resonance imaging and spectroscopy (MRS) in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the myocardial fat content study (MRS) following 6 months of treatment||percentage of myocardium content||Standard Error|Mean
12773|NCT01951573|Secondary|Over-refraction (OR) Monocular at Distance|OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.||Diopters|Participants|Standard Deviation|Mean
12774|NCT01951573|Secondary|HC/HI Binocular VA at Distance|Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.||logMAR||Standard Deviation|Mean
12775|NCT01951573|Primary|High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near|Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.||logMAR||Standard Deviation|Mean
12776|NCT01951417|Other Pre-specified|Stinging/Burning|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
12777|NCT01951417|Other Pre-specified|Dryness|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
12778|NCT01951417|Other Pre-specified|Scaling|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
12779|NCT01951417|Other Pre-specified|Erythema|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population||participants|||Number
12780|NCT01951417|Secondary|Subject Questionnaire|Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||participants|||Number
12781|NCT01951417|Secondary|Non-inflammatory Lesions|The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||lesions||Standard Deviation|Mean
12782|NCT01951417|Secondary|Inflammatory Lesions|The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||lesions||Standard Deviation|Mean
12783|NCT01951417|Primary|Total Lesion Count|The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)||lesions||Standard Deviation|Mean
12784|NCT01951170|Secondary|Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity|A tocilizumab antibody screen was performed at baseline and at the end of follow up (8 weeks after end of treatment at Week 32). A confirmatory anti-tocilizumab antibody test was performed on positive screen samples. A confirmed positive test indicates the presence of tocilizumab antibodies.|At baseline, Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||participants|||Number
12785|NCT01951170|Secondary|Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal||Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||adverse events|||Number
12786|NCT01951170|Secondary|Safety: Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants|||Number
12787|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Osteitis|Osteitis (bone inflammation) was assessed by MRI at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no osteitis, 1= 1-33% involvement of original articular bone, 2= 34-67% involvement of original articular bone and 3= 68-100% involvement of original articular bone. Total score was the sum of the 25 individual scores and ranged 0-75 with 0= no osteitis and 75= most severe osteitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
12788|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Synovitis|Synovitis (synovial membrane inflammation) was assessed by MRI at baseline and Week 24. Scans of 8 joint locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no synovitis, 1= 1-33% volume enhancement, 2= 34-67% volume enhancement and 3= 68-100% volume enhancement. Total score was the sum of the 8 individual scores and ranged 0-24 with 0= no synovitis and 24= most severe synovitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
12789|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Cartilage Loss|Cartilage loss was assessed by MRI at baseline and Week 24. Scans of 25 joints were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
12790|NCT01951170|Secondary|Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions|Bone erosions were assessed by magnetic resonance imaging (MRI) at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-10 on an 11-point scale with 0= no erosion, 1= 1-10% erosion, 2= 11-20% erosion, and up to 10= 91-100% erosion. Total score was the sum of the 25 individual scores and ranged 0-250 with 0= no erosion and 250= most severe erosion. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.||units on a scale||Standard Deviation|Mean
12791|NCT01951170|Secondary|Change From Baseline in Swollen Joint Count (SJC)|SJC was counted based on 66 joints (SJC66) and based on 28 joints (SJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||swollen joints||Standard Deviation|Mean
12792|NCT01951170|Secondary|Change From Baseline in Total Tender Joint Count (TJC)|TJC was counted based on 68 joints (TJC68) and based on 28 joints (TJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||tender joints||Standard Deviation|Mean
12793|NCT01951170|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|The CDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as CDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) with a total CDAI score ranging from 0-76. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; Severe disease = score > 22.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
12794|NCT01951170|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)|The SDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as SDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) + C reactive protein (CRP) in milligrams/deciliter (mg/dL) with a total SDAI score ranging from 0 to 86. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; Severe disease = score > 26.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
12838|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12795|NCT01951170|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|The FACIT measurement system is a collection of health-related quality of life questionnaires targeted to the management of chronic illness and includes questions on physical well-being, social/family well-being, emotional well-being and functional well-being. The FACIT-F Scale measures an individual’s level of fatigue during their usual daily activities. Total scores range from 0 to 52 with lower scores representing greater fatigue, and scores below 30 representing severe fatigue. A positive change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
12796|NCT01951170|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
12797|NCT01951170|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|"The Physician Global Assessment of Disease Activity is the investigator's overall assessment of the participant's current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in Physician Global Assessment of Disease Activity is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
12798|NCT01951170|Secondary|Change From Baseline in Patient’s Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)|"The PGA pain VAS is the participant's overall assessment of pain. Pain is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no pain and the right-hand extreme (100 mm) is described as unbearable pain. The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
12799|NCT01951170|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)|"PGA VAS is the participant's overall assessment of their current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.||units on a scale||Standard Deviation|Mean
12800|NCT01951170|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants||95% Confidence Interval|Number
12801|NCT01951170|Secondary|Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses|A positive ACR20 response requires at least 20% improvement compared to baseline in SJC (66 joints) and TJC (68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician’s global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) acute phase reactant (C-reactive protein [CRP] - if not available, ESR was used). ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants||95% Confidence Interval|Number
12802|NCT01951170|Secondary|Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient's global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Higher scores represent higher disease activity. DAS28-ESR remission is defined as a score < 2.6.|At Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.||percentage of participants||95% Confidence Interval|Number
12839|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12803|NCT01951170|Primary|Change From Baseline in Genant-modified Total Sharp Score (mTSS)|The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|From baseline to Week 24|Full Analysis Set (FAS) included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number analyzed represents the number of participants for whom the Week 24 X-ray was performed.||units on a scale||Full Range|Median
12804|NCT01951092|Secondary|Efficacy|Exploratory end point of PVL <200 copies at the end of the study|6 months|||participants|||Number
12805|NCT01951092|Primary|Number of Particpatns Who Considered the Intervention Feasible and Acceptable|A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.|6 months|All 20 participants who completed the study at 6 months participated in interviews and reported that the texting intervention was feasible and acceptable.||participants|||Number
12806|NCT01951066|Primary|Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent|Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).|1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent|||Pearson correlation coefficient (r)|||Number
12807|NCT01950741|Secondary|VFQ (Visual Function Questionaire)-25 Score|Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||scores on a scale||Inter-Quartile Range|Mean
12808|NCT01950741|Secondary|Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography|ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.|12 months|Among 45 patients who completed the study, data of 6 were inadequate for the analysis. 39 patients were included in the analysis.||percentage of patients|||Number
12809|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/40|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||percentage of patients|||Number
12810|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/200|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||percentage of patients|||Number
12811|NCT01950741|Secondary|Change in Visual Acuity From Baseline to 12 Months|Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change.|Baseline and 12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||letters||Full Range|Mean
12812|NCT01950741|Primary|Percentage of Patients Lose Visual Acuity Less Than 15 Letters|Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.||percentage of patients|||Number
12813|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12814|NCT01950364|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, body weight, blood pressure and heart rate.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
12815|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12816|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12817|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12818|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12819|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12820|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12821|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12822|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12823|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12824|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12825|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12826|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12827|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12828|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12829|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12830|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12831|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12832|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12833|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng||Standard Deviation|Geometric Mean
12834|NCT01950364|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
12835|NCT01950364|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin|Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.|Day 1 of Cycle 1 and 3|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
12836|NCT01950364|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.||participants|||Number
12837|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 480 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
14230|NCT01924182|Other Pre-specified|Sleep Assessment|"Compare changes from Baseline to Month 3 between the IT group and CMM group for:~Sleep and respiratory parameters collected via overnight polysomnography (PSG, sleep study)"|3 Month||||||
12840|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12841|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12842|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12843|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12844|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12845|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12846|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12847|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12848|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12849|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12850|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12851|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12852|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12853|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12854|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
13825|NCT01933425|Secondary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test||centimeters||95% Confidence Interval|Median
12855|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12856|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12857|NCT01950364|Secondary|Serum Concentration of Total Antibody (TAb)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12858|NCT01950364|Secondary|Serum Concentrations of Antibody-drug Conjugate (ADC)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12859|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).|Cycle 1: Predose|Pharmacokinetic (PK) analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.||ng/mL||Standard Deviation|Geometric Mean
12860|NCT01950078|Secondary|Preoperative Pressure Pain Tolerance (PTO)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say ok when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance."|30 minutes before the operation|||kg/cm2||Standard Deviation|Mean
12861|NCT01950078|Primary|Preoperative Pressure Pain Threshold (PPT)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say pain when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold."|30 minutes before the operation|||kg/cm2||Standard Deviation|Mean
12862|NCT01949870|Primary|The Number of Dose-limiting Toxicities|The number of dose-limiting toxicities in selumetinib in combination with cisplatin and gemcitabine|The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosing|Evaluable = completed at least 75% of planned daily doses of selumetinib at least 50% of planned dose of cisplatin/gemcitabine planned on Cycle 1 Day 8 (therefore, in total with Cycle 1 Day 1, at least 75 % of planned dose is given in Cycle 1) and has enough information to be assessed for the combination regimen dose escalation.||Participants|||Number
12863|NCT01949545|Secondary|Number of Participants With Adverse Events (AEs)|"Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.~Adverse events were graded using National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, on a scale from 1 (mild) to 5 (death)."|From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks|||participants|||Number
12864|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12865|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12866|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
12867|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12868|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12869|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
14231|NCT01924182|Secondary|Opioid-Related Side Effects|Summarize the changes from Baseline to Month 3 between the IT group and CMM group in CTCAE|3 Month||||||
12870|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12871|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12872|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
12873|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12874|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12875|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12876|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12877|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12878|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
12879|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12880|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12881|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as all participants who had adequate carfilzomib exposure and plasma concentration versus time data for the estimation of PK parameters by a non-compartmental analysis at each time point.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12882|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||liters||Geometric Coefficient of Variation|Geometric Mean
12883|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12884|NCT01949545|Secondary|Clearance of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||L/hour||Geometric Coefficient of Variation|Geometric Mean
12885|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
14232|NCT01924182|Secondary|Pain Assessment|Compare changes from Baseline to Month 3 between the IT group and CMM group in NPRS|3 Month||||||
12886|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
12887|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12888|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 56 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12889|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 56 mg/m²|The area under the curve from time zero to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12890|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 27 mg/m²||Cycle 1 day 16 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||liters||Geometric Coefficient of Variation|Geometric Mean
12891|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12892|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||hours||Geometric Coefficient of Variation|Geometric Mean
12893|NCT01949545|Secondary|Clearance of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||L/hour||Geometric Coefficient of Variation|Geometric Mean
12894|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||hours||Full Range|Median
12895|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12896|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 27 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12897|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 27 mg/m²|The area under the curve from time zero (defined as the start of carfilzomib infusion) to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as participants who received the intended carfilzomib dose (27 or 56 mg/m²) and who had plasma concentration versus time data for the estimation of each pharmacokinetic (PK) parameter by a non-compartmental analysis.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
12911|NCT01949532|Secondary|Maximum Observed Plasma Concentration for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12925|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
12898|NCT01949532|Secondary|Number of Participants With Adverse Events (AEs)|"Determination of the severity of all adverse events was assessed following the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Fatal.~A Serious AE is an AE that meets one or more of the following criteria:~Death,~Life-threatening experience;~Requires in-patient hospitalization or prolongation of an existing hospitalization,~Results in persistent or significant disability/incapacity,~Is a congenital anomaly/birth defect,~Important medical events that may not result in death, be life-threatening, or require hospitalization.~Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group.|All treated participants||participants|||Number
12899|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
12900|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
12901|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12902|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12903|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12904|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.||hours||Full Range|Median
12905|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
12906|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12907|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12908|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12909|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. T½ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.||hours||Full Range|Median
12910|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
13826|NCT01933425|Primary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test.||centimeters||Full Range|Median
12912|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. AUC0-∞ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12913|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|"PK evaluable population; One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. n indicates the number of participants included in the analyses at each time point."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12914|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters||Geometric Coefficient of Variation|Geometric Mean
12915|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.||hours||Geometric Coefficient of Variation|Geometric Mean
12916|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
12917|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.||hours||Full Range|Median
12918|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
12919|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12920|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the coefficient of correlation (R²) was < 0.8 were excluded.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12921|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12922|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters||Geometric Coefficient of Variation|Geometric Mean
12923|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Geometric Coefficient of Variation|Geometric Mean
12924|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
14421|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Body Weight||Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||kg||Standard Error|Least Squares Mean
12926|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||hours||Full Range|Median
12927|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
12928|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12929|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2|Carfilzomib plasma concentrations for pharmacokinetic (PK) analyses were measured by liquid chromatography with tandem mass spectrometry. The lower limit of quantitation (LLOQ) for the assay was 0.3 ng/mL.|Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. The PK evaluable population is defined as participants with sufficient carfilzomib plasma concentration versus time data for the estimation of PK parameters by non-compartmental analysis on cycle 1, day 16 and/or cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
12930|NCT01949389|Primary|Completion of All 7 Modules of the Intervention|"Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable).~The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program."|on average 7 weeks|||participants|||Number
12931|NCT01949389|Primary|Insomnia Severity Index (Total), Change From Baseline to Follow-up|"Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks)~The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia."|pre-intervention, intervention completion (expected average of 7 weeks)|The number of individuals provided access to the program and reporting baseline and follow-up data||units on a scale||Standard Deviation|Mean
12932|NCT01949155|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set||percentage of Microbiological response|||Number
12933|NCT01949155|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry measurements.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)||percentage of ears|||Number
12934|NCT01949155|Primary|Percentage of Participants Who Were Treatment Failures.|"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set||percentage of treatment failures|||Number
12935|NCT01949142|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set||percentage of Microbiological response|||Number
12936|NCT01949142|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)||percentage of ears|||Number
12937|NCT01949142|Primary|Percentage of Participants Who Were Treatment Failures|"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set||percentage of treatment failures|||Number
12947|NCT01948830|Secondary|The Average Number of Days Between Injections|The average dosing interval was measured as the average number of days between injections|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization||days||Standard Deviation|Mean
12948|NCT01948830|Secondary|The Mean Number of Treatment Frequency|The number of injections received|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization||Number of injections||Standard Deviation|Mean
12938|NCT01949051|Secondary|Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8|TNSS contains symtom scores for the four individual components (nasal congestion [NACG], rhinorrhea [RHSCR], nasal itching [NAITS] and sneezing [SNZS]), each scored on a 0 - 3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. The participants recorded their symptom scores on an e-diary. The mean score for each participant was calculated using the available diary data from the assessment periods, taking the average of non-missing data during the period. Weighted mean of the individual symptoms of theTNSS were calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
12939|NCT01949051|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|Per Protocol Population: all participants in the Intent-to-Treat Population (defined as all participants who were randomized and received >= 1 dose of study medication) and not identified as full protocol deviators with respect to criteria that were considered to impact the primary efficacy analysis. Only those participants contributing data at the||Scores on a scale||95% Confidence Interval|Least Squares Mean
12940|NCT01948908|Secondary|Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration|This outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted.|60 minutes|||participants|||Number
12941|NCT01948908|Secondary|Observational Scale of Behavioral Distress - Revised|The Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase.|60 minutes|||units||95% Confidence Interval|Mean
12942|NCT01948908|Primary|Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation|This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.|20 minutes|||minutes||95% Confidence Interval|Median
12943|NCT01948830|Secondary|Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)|The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome|Baseline, Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and post-baseline value at the specific visit were included for this analysis||Score on a scale||Standard Deviation|Mean
12944|NCT01948830|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at|To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages.|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization.||Percentage of participants|||Number
12945|NCT01948830|Secondary|Change in Central Subfield Retinal Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit|Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||microns||Standard Deviation|Mean
12946|NCT01948830|Secondary|Percentage of Participants With Fluid Free Macula Over Time up to Month 12|OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization||Percentage of participants|||Number
12949|NCT01948830|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome|Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||Number of participants|||Number
12950|NCT01948830|Secondary|Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.|Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||Number of participants|||Number
12951|NCT01948830|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline|Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.||Number of participants|||Number
12952|NCT01948830|Secondary|Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline|Baseline, Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit.||Letters (EDTRS)||Standard Deviation|Mean
12953|NCT01948830|Secondary|Average BCVA Change From Baseline to Month 12|"Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.~Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12"|Baseline, Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis.||Letters (EDTRS)||Standard Deviation|Mean
12954|NCT01948830|Secondary|Change in BCVA From Baseline to Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters|Baseline to Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.||Letters (EDTRS)||Standard Deviation|Mean
12955|NCT01948830|Secondary|Number of Visits Scheduled|The number of visits scheduled according to the treat and extend regimen after treatment initiation|From Month1 to Month 11|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed.||Number of visits||Standard Deviation|Mean
12956|NCT01948830|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.||Letters (EDTRS)||Standard Error|Least Squares Mean
12957|NCT01948791|Secondary|Change From Baseline in Caregiver Burden Inventory (CBI) Score|CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
12966|NCT01948375|Secondary|Degree of Acupuncture Pain|"The pain of acupuncture is assessed using visual analogue scale (VAS), where 0 means no pain, and 10 means the imaginable severest pain. The VAS value of each period is used to compare the difference of acupuncture pain between the placebo needle and the real needle.~A lower value represented a better outcome, which indicated that needles used induced less pain."|in the third acupuncture session in each period|||units on a scale||Standard Deviation|Mean
12992|NCT01947582|Secondary|Change in Impact of MS on Fatigue Using the 12-Item Walk Scale|The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.|Assessed at visit 2 (week 1) and week 24|||difference of sum of score|||Number
12958|NCT01948791|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score|This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency & severity of the behavior disorders, & allows rapid assessment using screening questions. 10 questions in behavior domain & 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1–4 points) and severity (range: 1–3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0–144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
12959|NCT01948791|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|MMSE was used to determine patient’s eligibility to participate, is an easy & practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration & attention) & performance (recall, response to written/verbal commands, writing ability & reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient’s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: <24=abnormal; Range: <21=Increased odds of dementia; >25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, <23=abnormal for high school education, <24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline & post-baseline values were calculated|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
12960|NCT01948791|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|ADCS-ADL is a scale based on caregiver’s assessment of patient’s activities of daily life. It is used in clinical studies on dementia & consists of 23 items and is designed to assess patient’s basic & instrumental activities of daily life, such as the abilities necessary for personal care, communicating & interacting with other people, maintaining a household, conducting hobbies & interests, & making judgments & decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or “yes” or “no” questions with separate sub-questions. Higher score & more “yes” answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient’s functions. The total score is the sum of the scores of all the items & sub-questions,& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
12961|NCT01948791|Primary|Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)|The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimer’s disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimer’s disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, and who had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window, and had no major protocol violations.||units on a scale||95% Confidence Interval|Mean
12962|NCT01948518|Secondary|Change in 6 Minute Walk Distance|The change in 6 minutes walk distance from baseline one hour after receiving 20 mg of sildenafil orally will be measured.|Baseline and one hour|||feet||Standard Deviation|Mean
12963|NCT01948518|Primary|Change in Diffusion Capacity Measured at Baseline and One Hour.|Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension|Baseline and one hour|||ml/min/mmHg||Standard Deviation|Mean
12964|NCT01948375|Secondary|Analysis of Factors Influencing Subject Blinding|The success of blinding was defined as the subject’s perception of needle penetration. Factors influencing subject blinding to be analyzed mainly referred to data of demography, needle type, acupuncture experience, needle sensation, acupuncture pain, and needle acceptability in the third acupuncture in each period.|in the third acupuncture session in each period||||||
12965|NCT01948375|Secondary|Acceptability of the Acupuncture Needle|"After the third acupuncture of each period, participants are asked to show their acceptance toward the needles with a 5-point scale: very difficult to accept, a little difficult to accept, acceptable, easy to accept, very easy to accept.~The needle acceptability between the placebo needle and real needle are compared.~Data of the acceptability of the placebo needle included rows 1-5, i.e., rows of placebo needle: very difficult to accept, placebo needle: a little difficult to accept, placebo needle: acceptable, placebo needle: easy to accept and placebo needle: very easy to accept.~Data of the acceptability of the real needle included rows 6-10, i.e., rows of real needle: very difficult to accept, real needle: a little difficult to accept, real needle: acceptable, real needle: easy to accept and real needle: very easy to accept."|in the third acupuncture session in each period|||participants|||Number
12967|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Degree of Needle Sensation|"The degree of needle sensation between the placebo needle and the real needle were compared.~The data of degree of needle sensation of the placebo needle included rows 1-4,i.e,, rows of placebo needle:no, placebo needle: mild, placebo needle: moderate and placebo needle: severe.~The data of degree of needle sensation of the real needle included rows 5-8, i.e., rows of real needle: no, ‘real needle: mild, real needle: moderate, and real needle: severe."|in the third acupuncture session in each period|||participants|||Number
12968|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Type of Needle Sensation|This questionnaire is used to collect the types and degree of needle sensation experienced by participants. Information is collected after the third acupuncture session in each period. The difference between two kinds of needles is to be analyzed.|in the third acupuncture session in each period|||participants|||Number
12969|NCT01948375|Primary|Proportion of Volunteers’Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.|"The primary outcome was the proportion of volunteers’perception of needle penetration between the placebo needle and the real needle in the third acupuncture session in each period.~LI4, on the dorsum of the hand, between the first and second metacarpal bones, approximately in the center of the second metacarpal bone; RN12, on the upper abdomen,4 cun above the umbilicus,on the anterior midline; BL36, on the back of the thigh,on the midpoint of the inferior gluteal crease; BL25, on the loin, 1.5 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra."|in the third acupuncture session in each period|||participants|||Number
12970|NCT01948193|Primary|Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.|Pre-dose 1 to one month post-dose 3|Vaccine response was assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
12971|NCT01948193|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Injection site reactions: Tenderness, Cries when injected limb is moved, or reduced movement of injected limb; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes/24 hours or requires parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time/difficult to wake up; Appetite lost, Refuses ≥3 or most feeds/meals; Irritability, Inconsolable.|Within 7 days after each vaccine injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
12972|NCT01948193|Secondary|Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, PT and FHA antibodies by an ELISA, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titer ratios were assessed in the Per-protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
12973|NCT01948193|Secondary|Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, tetanus, PT, and FHA antibodies by an ELISA, PRP antibodies by a Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
12974|NCT01948193|Primary|Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.~Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
12975|NCT01948193|Secondary|Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.~Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
12990|NCT01947582|Secondary|Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)|Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.|Assessed at visit 2 (week 1) and week 24|||persons|||Number
12976|NCT01948076|Secondary|Improvement in Diagnostic Ability Within the Intervention Group|"For the secondary outcome, we assessed whether there was an improvement in the diagnostic ability of those in the intervention group using traditional physical examination techniques as compared to using the ultrasound device. We compared the two arms using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent using their physical exam alone and then again after using the ultrasound. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month|||units on a scale||Inter-Quartile Range|Mean
12977|NCT01948076|Primary|Comparison of Diagnostic Ability of the Intervention Group's Ultrasound Exam to the Control Group's Physical Exam|"The primary outcome is a comparison of the diagnostic ability of the intervention group as recorded after performing an ultrasound exam and the control group using traditional physical examination techniques. We compared the two groups using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The former is a gauge of a resident's ability to correctly identify present abnormalities while the latter is an assessment of correctly identifying a normal examination when findings are absent. The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent and how confident he or she was in their answer. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month|All residents were analyzed. There was one withdrawal due to family emergency||units on a scale||Inter-Quartile Range|Mean
12978|NCT01948050|Primary|Pain Intensity|"Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure Pain intensity assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2)."|Assessed at baseline and post tDCS stimulation day 5|||Points on numerical rating scale||Standard Error|Mean
12979|NCT01947946|Primary|Asthma Exacerbations Over 48 Weeks Treatment|The number of asthma exacerbations over 48 weeks treatment will be counted|48 weeks treatment|Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.||Number of events|||Number
12980|NCT01947907|Secondary|Annualized Height Velocity|Annualized HV during treatment with ACP-001 or daily rhGH at the end of 6 months, for each ACP-001 dose group and for the daily rhGH dose group|Baseline to 6 months (Visit 5)|||cm/year||Standard Deviation|Mean
12981|NCT01947907|Primary|AUEC0-168h of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the rhGH group.~Uncorrected AUEC0-168 (area under the efficacy curve from 0h-168h) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)|||h*ng/mL||Standard Deviation|Mean
12982|NCT01947907|Primary|Emax of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the daily rhGH group"|0 hours to 168 hours at Visit 3 (Week 13)|||ng/mL||Standard Deviation|Mean
12983|NCT01947907|Primary|E-Trough of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during Visit 1 and Visit 3 compared between the ACP-001 dose groups and to the daily rhGH group~Uncorrected E-Trough (the pre-dose efficacy response) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)|||ng/mL||Standard Deviation|Mean
12984|NCT01947907|Primary|AUC0-168h of hGH|"As part of the following endpoint:~PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the PK profile of hGH from the daily rhGH group during Visit 1 and Visit 3~Uncorrected AUC0-168h (area under the curve from 0h to 168h) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)|||h*ng/mL||Standard Deviation|Mean
12985|NCT01947907|Primary|Cmax of hGH|"As part of the following endpoint:~PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the pharmacokinetic (PK) profile of hGH from the daily rhGH groups during visit 1 and 3.~Uncorrected Cmax (maximum value of concentration) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)|||ng/mL||Standard Deviation|Mean
12986|NCT01947907|Primary|Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)|Assessment of local tolerability was performed by examining injection sites (by the investigator during study visits) and on the basis of anamnestic data and records in the Patient Diary. Assessments included pain, redness, bruising, swelling, and itching. Every subject was counted only once within each symptom category.|Start of study treatment through Visit 5 (Week 27)|||Number of subjects with any symptom|||Number
12987|NCT01947907|Primary|Incidence of Anti-hGH Neutralizing Antibody Formation|Number of subjects with positive results for anti-hGH neutralizing antibodies at two consecutive post-dose visits|Visit 2 - Visit 5|||participants|||Number
12988|NCT01947907|Primary|Incidence of Anti-hGH Binding Antibody Formation|Number of subjects with positive results for anti-hGH binding antibodies at two consecutive post-dose visits|Visit 2 - Visit 5|Safety analysis set includes all patients who receive at least one dose of planned study medication||participants|||Number
12989|NCT01947855|Primary|Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment|The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.|1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28|Full analysis set||mg*h/dL||Standard Error|Least Squares Mean
12991|NCT01947582|Secondary|Change in Step Length Using the GAITRite Computerized Gait Analysis System|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.|Assessed at visit 2 (week 1) and week 24|||cm|||Number
15415|NCT01890148|Secondary|Summary for Change From Baseline for GRO-alpha by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set||pg/ml||Standard Deviation|Mean
12993|NCT01947582|Primary|Change in Walking Distance During 6-Minute Walk Test|Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.|Assessed at visit 2 (week 1) and week 24|||feet|||Number
12994|NCT01947491|Primary|Percentage of Participants With Success According to the Investigator Global Assessment (IGA)|IGA of clear or almost clear|Day 15|Efficacy was only done on DFD01 Spray and Vehicle Spray. Protocol specifically noted no efficacy would be done on comparator or its vehicle.||percentage of patients||95% Confidence Interval|Number
12995|NCT01947335|Secondary|Incidence of Contrast-induced Nephropathy|Increase >= 0.5 mg/dl in basal serum creatinine|7 days|||percentage of participants|||Number
12996|NCT01947335|Secondary|Major Adverse Cardiac Events|Composite of death, myocardial infarction or repeat revascularization|30 days and 6 months|||participants|||Number
12997|NCT01947335|Primary|Total Volume of Iodine Contrast Used During Procedure|Total volume of iodine contrast administered during the index procedure.|Day 1|||ml||Inter-Quartile Range|Median
12998|NCT01947153|Secondary|Linagliptin: AUC 0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Linagliptin:~AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
12999|NCT01947153|Secondary|Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Metformin:~AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
13000|NCT01947153|Secondary|Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Linagliptin:~AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
13001|NCT01947153|Primary|Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Metformin:~Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin||ng/mL||Geometric Coefficient of Variation|Geometric Mean
13002|NCT01947153|Primary|Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Linagliptin:~Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol/L||Geometric Coefficient of Variation|Geometric Mean
13003|NCT01947153|Primary|Metformin: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Metformin:~AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|The subject set for the evaluation of pharmacokinetic endpoints of metformin (PKS-M): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
13004|NCT01947153|Primary|Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours)|"Linagliptin:~AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|subject set for the evaluation of pharmacokinetic endpoints of linagliptin (PKS-L): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
13005|NCT01947127|Secondary|Hospital Length of Stay|Numbers of days spent in the hospital since the emergency department arrival to hospital discharge|Patients will be followed for the duration of hospital stay, an expected average of 7 days|||Days||Inter-Quartile Range|Median
13064|NCT01945944|Secondary|Dead Space|in % of tidal volume, using parameters on mechanical ventilator. Dead space is a measure of how much of the lung is not able to move air into and out of the body. Higher levels of dead space reflect higher levels of lung dysfunction.|during mechanical ventilation (typically 4 days - 2 weeks)|||percentage of lung volume||Inter-Quartile Range|Median
37304|NCT01488994|Secondary|Safety: Number of Participants With Severe Allergic Reactions, e.g. Anaphylaxis||Throughout study period (approximately 17 months)|||Participants|||Number
13006|NCT01947127|Secondary|All-cause Mortality Rates|Electronic database retrieval of in- and outpatient clinical records together with telephone follow-ups to the patients or their contact personnel are employed to every case in the next 30 days after the day of presentation to the emergency department to identify the deceased cases. All-cause mortality rates of each cohort will be compared by the survival analysis.|30 days after the day of presentation to the emergency department|Four patients out of 392 patients were excluded from secondary (mortality) outcome analysis due to unknown mortality status. As a result, 388 patients (139 in high lactate group and 249 in low lactate group) were available for mortality outcome analysis.||participants|||Number
13007|NCT01947127|Primary|Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator|Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement.|72 hours after venous lactate measurement|||participants|||Number
13008|NCT01946542|Secondary|Vascular Function|flow-mediated dilation (FMD)|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.|||||
13009|NCT01946542|Primary|Exercise Tolerance|treadmill time to exhaustion, cardiopulmonary exercise test|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.|||||
13010|NCT01946529|Secondary|Local Failure Rate|Loco-regional failure is defined as the time interval from date of start of local therapy to date of loco-regional failure. Distant failure or death prior to loco-regional failure will be considered competing events in the analyses. The cumulative incidence of loco-regional failure will be estimated using methods described in Kalbfleisch and Prentice.|Maximum of 11 years after the start of therapy||||||
13011|NCT01946529|Secondary|Time to Progression|Median time to progression of group B patients will be estimated from the Kaplan-Meier curve.|Maximum of 11 years after the start of therapy||||||
13012|NCT01946529|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the date on study to the date of disease progression or death or the date if last follow-up. PFS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy||||||
13013|NCT01946529|Secondary|Overall Survival|Overall survival (OS) is defined as the time interval from the date on study to the date of death or the date of last follow-up. OS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy||||||
13014|NCT01946529|Primary|Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants|Response rate will be defined as the proportion of patients who achieved complete response or partial response (CR+PR) using the World Health Organization (WHO) criteria evaluated after two initial courses of temsirolimus, temozolomide and irinotecan in previously untreated patients with high risk Ewing Sarcoma Family of Tumor (ESFT). Participants who are treated in Group B with Desmoplastic Small Round Cell Tumor (DSRCT) or those who do not receive window therapy will not be included in this analysis.|at 6 weeks after start of therapy (after 2 initial courses)|Of the 17 Group B participants with high-risk ESFT, 12 received window therapy and are considered evaluable for this outcome.||participants|||Number
13015|NCT01946438|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.|Day 21 after vaccination|Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set.||Titer Ratio||95% Confidence Interval|Geometric Mean
13016|NCT01946438|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination.|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set.||Participants|||Number
13017|NCT01946438|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
13018|NCT01946438|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 after vaccination|Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
13019|NCT01946438|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.|Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 21 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
13020|NCT01946425|Primary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|"Solicited injection-site reactions (6 months to <36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, >103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.~Solicited injection-site reactions (3 years to < 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all participants who received at least one dose of study vaccine.||Participants|||Number
13021|NCT01946425|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccine.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Titer Ratio||95% Confidence Interval|Geometric Mean
13022|NCT01946425|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
13023|NCT01946425|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
13024|NCT01946425|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
13025|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||kg/m^2||Standard Deviation|Mean
13026|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
13027|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||cm||Standard Deviation|Mean
13028|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||Centimeters (cm)||Standard Deviation|Mean
13029|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||Kg||Standard Deviation|Mean
13065|NCT01945944|Secondary|Oxygenation|SaO2/FiO2. This is a measure of how will the lungs are providing oxygen to the body. Higher ratios reflect better lung function.|during mechanical ventilation (typically 4 days - 2 weeks)|||ratio||Inter-Quartile Range|Median
13066|NCT01945944|Secondary|Dynamic Compliance|measured in ml/cm H20/kg using parameters on mechanical ventilator|during mechanical ventilation (typically 4 days - 2 weeks)|||mL/kg/cm-H20||Inter-Quartile Range|Median
13030|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145)|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||kilogram (kg)||Standard Deviation|Mean
13031|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of >=15 microliter was required for determination of sweat chloride. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||mmol/L||Standard Deviation|Mean
13032|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively.As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||millimole per liter (mmol/L)||Standard Deviation|Mean
13033|NCT01946412|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation was considered treatment-emergent.|Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)|Safety set included all participants who received at least 1 dose of study drug in study 109 (NCT01946412). As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).||participants|||Number
13034|NCT01946243|Primary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
13035|NCT01946243|Secondary|Change in Reliability (Siemens Syngo.PET Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection|||Fleiss Kappa||95% Confidence Interval|Number
13036|NCT01946243|Secondary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
13037|NCT01946243|Secondary|Change in Reliability (MIMNeuro Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection|||Fleiss Kappa||95% Confidence Interval|Number
13038|NCT01946243|Secondary|Change in Total Accuracy (MIMNeuro Software, All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
13039|NCT01946243|Primary|Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection|||Percent Accuracy||Standard Error|Mean
13040|NCT01946178|Post-Hoc|Total Time Required to Deliver Treatment|The total treatment time was measured for each patient from the beginning of HIFU energy emission until HIFU energy emission stopped.|The total treatment time was measured on the day of treatment.|Total treatment times are reported for all treated patients. Total treatment times are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.||minutes||Full Range|Mean
13041|NCT01946178|Secondary|HIFU-related Non-Perfused Volume (NPV)|Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.|The NPV was measured between 0 and 7 days post-treatment.|HIFU-related Non-Perfused Volumes (NPVs) are reported for all treated patients in whom they were observed following treatment. NPV outcomes are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.||cubic centimeters (cc)||Full Range|Mean
39491|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)||||||
13042|NCT01946178|Primary|Evaluation of All Adverse Events Encountered|Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.|Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).|All Adverse Device Effects are reported for the entire study population (all treated patients).||Adverse Device Effects / patient||Full Range|Mean
13043|NCT01946126|Secondary|Number of Visits for Headache Diagnosis|The number of visits for headache diagnosis is evaluated through the study period.|15 Months|All enrolled subjects||Visits||Standard Deviation|Mean
13044|NCT01946126|Secondary|Highest Number of Headache Days Per Month at a Qualifying Visit|The highest number of headache days per month are reported at a qualifying visit per the medical record.|15 Months|All enrolled subjects with data for this outcome measure||Days||95% Confidence Interval|Mean
13045|NCT01946126|Secondary|Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches|The number of headache days is reported at the visit with the highest number of headaches.|15 Months|All enrolled subjects||Headache Days||95% Confidence Interval|Mean
13046|NCT01946126|Secondary|Number of Unique Prophylactic Medications for Headache/Migraine Reported|The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.|15 Months|All enrolled subjects||Medications||Standard Deviation|Mean
13047|NCT01946126|Primary|Presence or Absence of Prophylactic Medication for Headache/Migraine|The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.|15 Months|All enrolled subjects||Participants|||Number
13048|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|||percentage of vascular dilation||Standard Deviation|Mean
13049|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat||percentage of vascular dilation||Standard Deviation|Mean
13050|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|||percentage of vascular dilation||Standard Deviation|Mean
13051|NCT01945970|Other Pre-specified|Endothelium-Independent Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|||percentage of vascular dilation||Standard Deviation|Mean
13052|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat||percentage of vascular dilation||Standard Deviation|Mean
13067|NCT01945944|Secondary|Change in Serum Sodium From Baseline|The baseline sodium was the last level measured prior to study initiation, typically within 24hrs of study initiation. The change in blood sodium level was calculated as the difference between the mean post-enrollment sodium level during ICU care and the sodium level at enrollment.|during hospitalization (typically 4 days - 2 weeks)|||mEq/L||Inter-Quartile Range|Median
13068|NCT01945944|Secondary|Hospital Length of Stay||during hospitalization (typically 4 days - 2 weeks)|||days||Inter-Quartile Range|Median
13053|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Black Tea|"FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat||percentage of vascular dilation||Standard Deviation|Mean
13054|NCT01945970|Other Pre-specified|Diastolic Blood Pressure, Positive Control|Change in Diastolic Blood pressure|From before consumption on day 1 to before consumption day 8|||mmHg||Standard Deviation|Mean
13055|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Positive Control|Change in systolic blood pressure|From before consumption (baseline) day 1 to before consumption day 8|Intention to treat||mmHg||Standard Deviation|Mean
13056|NCT01945970|Other Pre-specified|Diastolic Blood Pressure Black Tea|Change in Diastolic blood pressure|From before consumption on day 1 to before consumption day 8|||mmHg||Standard Deviation|Mean
13057|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Black Tea|Change in Systolic blood pressure|From before consumption on day 1 to before consumption on day 8|||mmHg||Standard Deviation|Mean
13058|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Mean
13059|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Mean
13060|NCT01945970|Secondary|Flow Mediated Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
13061|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption day 1 to before consumption day 8.|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
13062|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat||percentage of in flow mediated dilation||Standard Deviation|Least Squares Mean
13063|NCT01945970|Primary|Flow Mediated Dilation, Acute-upon-chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8.|Intention to treat||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
13071|NCT01945944|Secondary|Atelectasis|"using chest x ray score. The score measures the amount of lung collapse (atelectasis) observed on a chest x-ray. For each of the 5 lung lobes, 1 point is given for linear atelectasis, 2 points for sub-segmental atelectasis and 3 points for lobar atelectasis. The range is 0-15 points, with higher scores reflecting more severe lung collapse."|during mechanical ventilation (typically 4 days - 2 weeks)|||units on a scale||Inter-Quartile Range|Median
13072|NCT01945944|Primary|Duration of Mechanical Ventilation||typically 4 days - 2 weeks|||hours||Inter-Quartile Range|Median
13073|NCT01945294|Secondary|Percentage of Participants With Treatment-Related Serious AEs (SAEs)|A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.|Up to 60 weeks|The APaT includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
13074|NCT01945294|Secondary|Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.|From TW1 through TW48|The APaT includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
13075|NCT01945294|Secondary|Percentage of Participants With Anemia|The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
13076|NCT01945294|Secondary|Percentage of Participants With Neutropenia|The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.||Percentage of Participants|||Number
13077|NCT01945294|Secondary|Percentage of Participants With Relapse|The percentage of viral relapse (defined as confirmed HCV RNA >15 IU/mL after End-of-Treatment [EOT]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|From EOT to FW12 (up to 12 weeks)|Participants in the FAS with undetectable HCV RNA at EOT and who have data available at FW12 were included.||Percentage of Participants|||Number
13078|NCT01945294|Secondary|Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment|The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA <LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|The subset of the FAS population consisting of all participants treated with any study medication in Arms 1, 2, and 3 and who had undetectable HCV RNA at Week 4, Week 8, or Week 12.||Percentage of Participants|||Number
13079|NCT01945294|Secondary|Percentage of Participants With Undetectable HCV RNA Across Treatment|The percentage of participants with undetectable HCV RNA (HCV RNA <LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|Participants in the FAS population (consisting of all participants treated with any study medication who had undetectable HCV RNA at TW8 and were randomized to Arm 1 or Arm 2, and participants with detectable HCV RNA at TW8 in Arm 3) with available data.||Percentage of Participants|||Number
13080|NCT01945294|Primary|Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]|SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|Follow-up Week (FW) 12 (up to 40 weeks)|Participants of the Full Analysis Set (FAS) who were treated with any study medication, had undetectable HCV RNA at TW8, and were randomized to Arm 1 or Arm 2. Participants in Arm 3 were not included in the primary efficacy analysis as pre-specified by the protocol.||Percentage of Participants|||Number
13081|NCT01945242|Secondary|Change From Baseline in Fasting Insulin|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||mg/dL||Standard Deviation|Mean
13082|NCT01945242|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
13083|NCT01945242|Secondary|Percentage of Participants of Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||percentage of participants|||Number
13241|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13084|NCT01945242|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
13085|NCT01945242|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
13086|NCT01945242|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.||participants|||Number
13087|NCT01945138|Secondary|6 Month Follow-Up: Peak C-Peptide||6 Month Follow-Up:||12/2016||||
13088|NCT01945138|Secondary|6 Month Follow-Up: Fasting BG||6 Month Follow-Up:||12/2016||||
13089|NCT01945138|Secondary|6 Month Follow-Up: Total Daily Insulin Dose||6 Month Follow-Up:||12/2016||||
13090|NCT01945138|Secondary|6 Month Follow-Up: A1c||6 Month Follow-Up:||12/2016||||
13091|NCT01945138|Secondary|Day 28 Follow-Up: C-Peptide||Day 28 Follow-Up|||ng/mL||Standard Deviation|Mean
13092|NCT01945138|Secondary|Day 28 Follow-Up: Average Serum BG||Day 28 Follow-Up|||mg/dL||Standard Deviation|Mean
13093|NCT01945138|Secondary|Day 14 Follow-Up: C-Peptide||Day 14 Follow-Up:|||ng/mL||Standard Deviation|Mean
13094|NCT01945138|Secondary|Day 14 Follow-Up: Average Serum BG||Day 14 Follow-Up|||mg/dL||Standard Deviation|Mean
13095|NCT01945138|Secondary|Study Period: Daily Insulin Needs|Calculated as total daily dose of insulin.|Average of 3 day study period|||U/kg/day||Standard Deviation|Mean
13096|NCT01945138|Secondary|Study Period: Morning C-peptide|A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient.|Average of 3 day study period|||ng/mL||Standard Deviation|Mean
13097|NCT01945138|Secondary|Study Period: % of Time CGM BG > 140 mg/dL||continuous over the 72 hour investigation period|||% of time||95% Confidence Interval|Mean
13098|NCT01945138|Secondary|Study Period: CGM AUC With Glucose> 140 mg/dL||continuous over the 72 hour investigation period|||min*mg/dL/day||Standard Deviation|Mean
13099|NCT01945138|Secondary|Study Period: % of Time CGM BG <70 mg/dL||continuous over the 72 hour investigation period|||% of time||95% Confidence Interval|Mean
13100|NCT01945138|Secondary|Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL|Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.|continuous over the 72 hour investigation period|||min*mg/dL/day||Standard Deviation|Mean
13101|NCT01945138|Secondary|Study Period: Percent Time BG in Range 70-140 mg/dL|Additional measure of glycemic variability|continuous over the 72 hour investigation period|||% of time||95% Confidence Interval|Mean
13102|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor Standard Deviation of BG|measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.|continuous over the 72 hour investigation period|||mg/dL||Standard Deviation|Mean
13103|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor (CGM) BG Average|Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period|continuously over the 72 hour investigational period|||mg/dL||Standard Deviation|Mean
13104|NCT01945138|Primary|Study Period: Serum BG Standard Deviation|Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.|3 days of investigation period|||mg/dL||Standard Deviation|Mean
13105|NCT01945138|Primary|Study Period: Average Serum BG|Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.|3 days of investigation period|||mg/dL||Standard Deviation|Mean
13106|NCT01945086|Secondary|Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 3=severe, on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
13400|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
13107|NCT01945086|Secondary|Percent Change From Baseline of Body Region Scores in EASI|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||percent change||Standard Deviation|Mean
13108|NCT01945086|Secondary|Percent Change From Baseline in EASI Sign of Disease Components|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||percent change||Standard Deviation|Mean
13109|NCT01945086|Secondary|Percent Change From Baseline in EASI Total Score|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively. LOCF method was not applied to impute the missing data.||percent change||Standard Deviation|Mean
13110|NCT01945086|Secondary|Number of Participants in IGA|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
13111|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
13112|NCT01945086|Secondary|Number of Participants With an IGA Score of “Clear” or “Almost Clear”|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
13113|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||participants|||Number
13114|NCT01945086|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.||units on a scale||Standard Deviation|Mean
15416|NCT01890148|Secondary|Summary for Change From Baseline for IL-8 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set||pg/ml||Standard Deviation|Mean
13115|NCT01945086|Secondary|Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12|The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching.|Baseline and Week 12|FAS population was used for analysis. LOCF method was used to impute the missing data. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.||units on a scale||Standard Deviation|Mean
13116|NCT01945086|Secondary|"Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12"|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.||participants|||Number
13117|NCT01945086|Primary|Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90 percent [%]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 12|Full Analysis Set (FAS) included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. Last Observation Carried Forward (LOCF) method was used to impute the missing data.||percent change||Standard Deviation|Mean
13118|NCT01945034|Secondary|Percentage of Participants Taking Rescue Medication|Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.|Post first dose Day 1 up to Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Percentage of participants|||Number
13119|NCT01945034|Secondary|Number of Doses of Rescue Medication Used During the First 7 Days of Dosing|Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.|Baseline up to Day 7|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Doses||Standard Deviation|Mean
13120|NCT01945034|Secondary|Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose|Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.|Post-Dose on Day 1 up to Day 10|Data was not analyzed since <20% participants used rescue medication.|||||
13121|NCT01945034|Secondary|Time to First Perceptible Relief and Meaningful Relief|"Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: “Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief”. First perceptible relief was considered confirmed by meaningful relief if participant achieved both first perceptible and meaningful relief by either pressing second stopwatch or by indicating that his/her first perceptible relief was also meaningful. For “time to meaningful relief,” exact question asked was: “Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you.” Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered."|0 to 3 hours on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
13122|NCT01945034|Secondary|Participant’s Global Assessment of Medication at End of Study|Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.|Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment. Number of participants analyzed 'N' signifies those participants who were evaluable for the measure.||Units on a scale||Standard Deviation|Mean
13141|NCT01945021|Secondary|Time to First Response|Time to response is defined as the time from the date of first dose to first documentation of objective tumor response (CR or PR), as assessed by Independent Radiology Review, that is subsequently confirmed. For patients proceeding from PR to CR, the onset of PR is taken as the onset of response.|From date of first dose of crizotinib every 8 weeks or 12 weeks until first documentation of objective response is observed, until 6 months after the last subject is enrolled on the trial|Analysis is based on 88 patients who achieved an objective response as assessed by Independent Radiology Review||months||Full Range|Median
13123|NCT01945034|Secondary|Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10|Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can’t resume normal activities; 4= Moderately restricted walking due to pain and can’t resume normal activities; 5= Severely restricted walking due to pain and can’t resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
13124|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 7 days (0-168 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
13125|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest Over 3 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
13126|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3|PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 6 hours on Day 1, over 2 hours on Day 3|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
13127|NCT01945034|Secondary|Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points|PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.|Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
13128|NCT01945034|Secondary|Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10|The physician assessment of the severity of the ankle injury was based on the participant’s individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
13129|NCT01945034|Secondary|Change From Baseline in Participant’s Global Assessment of Ankle Injury at Day 3 and 10|Participant’s global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
13130|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
13131|NCT01945034|Primary|Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
13132|NCT01945034|Primary|Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.||units on a scale||Standard Error|Least Squares Mean
13133|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. Scores on each sub-scale range from 0 - 100. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8||units on a scale||Standard Deviation|Mean
13134|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30)|The QLQ-C30 consists of 30 questions which are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social domains); a global health status/global QOL scale; 3 symptom scales (fatigue, pain, nausea and vomiting scales); and 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and the perceived financial burden of treatment. Scores for each sub-scale range from 0 to 100. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8||units on a scale||Standard Deviation|Mean
13135|NCT01945021|Secondary|Number of Patients With a Shift of Chemistry Laboratory Results From Grade </= 2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose chemistry laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment|||participants|||Number
13136|NCT01945021|Secondary|Number of Patients With a Shift in Hematology Laboratory Results From Grade </=2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose hematology laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment|||participants|||Number
13137|NCT01945021|Secondary|Type, Incidence, Severity, Seriousness and Relationship to Study Medications of Adverse Events (AE) and Any Laboratory Abnormalities|Incidence of patients experiencing a treatment emergent adverse events were summarized by type, incidence, severity, seriousness and relationship to study medication.|From the date of signed informed consent, then a minimum of every 4 weeks until 32 weeks, then a minimum of every 8 weeks, or until 4 weeks after last dose of treatment|||percentage of patients|||Number
13138|NCT01945021|Secondary|Overall Survival||Assessed from date of date of the first dose of crizotinib until the date of death from any cause, assessed up to 6 months after the last subject is enrolled on the trial|OS is defined as the time from the date of the first dose of crizotinib to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.||months||95% Confidence Interval|Median
13139|NCT01945021|Secondary|Progression Free Survival Assessed by Independent Radiology Review|Progression Free Survival is defined as the time from the date of the first dose of crizotinib to first documentation of objective disease progression or to death on study due to any cause, whichever occurs first. Patients who had neither progression nor death without objective progression were censored at the time of data cut off.|From the date of first dose of crizotinib every 8 weeks or 12 weeks until the first documentation of objective disease progression or death|||months||95% Confidence Interval|Median
13140|NCT01945021|Secondary|Disease Control Rate at 8 Weeks by Independent Radiology Review|The Disease Control Rate at 8 weeks is defined as the number of patients with a confirmed CR, confirmed PR, or SD at 8 weeks, respectively, according to RECIST v1.1 (as determined by IRR), relative to the total population of response evaluable patients.|Measured once at 8 weeks after the start of study treatment|||participants|||Number
13418|NCT01940120|Other Pre-specified|Cardiac Output|Cardiac output as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac output evaluation was not done or un-evaluable.||l/min||Standard Deviation|Mean
13142|NCT01945021|Secondary|Duration of Response by Independent Review|The time from the first documentation of objective tumor response (CR or PR) according to Independent Review and that was subsequently confirmed to the first documentation of objective disease progression or to death due to any cause, whichever occurs first. It was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response and who had a subsequent event of progression or death without progression. Patients who did not meet these criteria were censored on the date of the last on-study tumor assessment.|Every 8 or 12 weeks until 6 months after the last patient was enrolled in the trial|Duration of response was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response by Independent Review and who either subsequently had objective progression or died, whichever occurred first.||months||Standard Deviation|Mean
13143|NCT01945021|Primary|Independent Radiology Reviewed Overall Objective Response (ORR)|Overall Objective Response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review [IRR]), relative to the total population of response-evaluable patients (n=127). Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response.|Starting from the first dose study treatment until the first documented CR or PR.|||participants|||Number
13144|NCT01944969|Secondary|Change in Health-related Quality of Life|The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient’s wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). Due to the limited number of enrolled patients, no data were summarised for reporting and the data did not allow for any meaningful analyses.|||||
13145|NCT01944969|Secondary|Change in Health-related Quality of Life|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).|||||
13146|NCT01944969|Secondary|Change in Clinical Global Impression|Clinical Global Impression - Severity of illness (CGI-S) score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).|||||
13147|NCT01944969|Secondary|Proportion of Patients in Remission|Based on a pre-specified MADRS total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).|||||
13148|NCT01944969|Secondary|Change in Depressive Symptoms|The Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From baseline to Week 52|None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients).|||||
13149|NCT01944969|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.|From baseline to Week 52|all-patients treated set (APTS)||participants|||Number
13150|NCT01944969|Primary|Tolerability|Number of withdrawals|From baseline to Week 52|26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons.||participants|||Number
13151|NCT01944969|Primary|Safety|Number of adverse events|From baseline to Week 52|||Adverse events|||Number
13152|NCT01944878|Secondary|The Association Between PUD and HVPG in Patients With Chronic Hepatitis||Retrospective case-control study (from 2009 to 2012, up to 3 years)|||mmHg||Inter-Quartile Range|Median
13153|NCT01944878|Primary|The Association of HVPG and PUD in Patients With Liver Cirrhosis|"The association of hepatic vein pressure gradient that reflects portal hypertension and peptic ulcer disease in patients with liver cirrhosis was assessed statistically.~(NO specific time frame, only confined to 2009 to 2012, when the HVPG measurement was done). The Mann-Whitney test was used to evaluate the association between PUD or not and HVPG degree, by SPSS software."|Retrospective case-control study (from 2009 to 2012, up to 3 years)|||mmHg||Inter-Quartile Range|Median
13154|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
13155|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
13156|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
13157|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
13158|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
13159|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
13160|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.||participants|||Number
13161|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.||participants|||Number
13162|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the CE population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.||participants|||Number
15914|NCT01875510|Primary|Number of Participants With Retinopathy of Prematurity|The number of Participants with Retinopathy of Prematurity will be defined.|Corrected age 32 weeks or postnatal 28th day|||participants|||Number
13163|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the mITT population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.||participants|||Number
13164|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the CE population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.||participants|||Number
13165|NCT01944774|Primary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.||participants|||Number
13166|NCT01944631|Secondary|Patient Overall Assessment of Efficacy|"Patient overall assessment of efficacy was assessed by the question How effective was the treatment in relieving your common cold symptoms? at day 10. A 5-point scale was used (0=poor, 1=fair, 2=good, 3=very good, 4=excellent)."|Day 10|FAS||percentage of participants|||Number
13167|NCT01944631|Secondary|Duration of the Cold|"Duration of the common cold was assessed by the question Do you still have a cold? at the end of each treatment day. The duration of the cold was defined as ended by the first day of a No answer to this daily question."|Baseline up to 10 days|FAS||days||95% Confidence Interval|Median
13168|NCT01944631|Secondary|Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The Area under the curve (AUC) over the 10-day period for the total symptom score (AUC-TSS 1-10) was calculated as the sum of the TSS calculated on each day from day 1 to day 10. AUC-TSS 1-10 ranges from 0 (no symptoms) to 270 (severe symptoms)."|Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10|FAS||units on a scale * days||Standard Error|Least Squares Mean
13169|NCT01944631|Secondary|Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)|"The mean of the sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing).~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean of the sum of 5 single local common cold symptom scores over days 2 to 4 was calculated as (LSS2 + LSS3 + LSS4)/3 where LSS2, LSS3 and LSS4 are the local common cold symptom scores calculated for days 2, 3 and 4 respectively. LSS2-4 ranges from 0 (no symptoms) to 15 (severe symptoms)."|Days 2, 3 and 4|FAS||units on a scale||Standard Error|Least Squares Mean
13209|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial oxygen pressure (PaO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||mmHg||Standard Error|Least Squares Mean
14749|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks|||Joints||Inter-Quartile Range|Median
13170|NCT01944631|Secondary|Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)|"The mean of the sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness).~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean of the sum of 3 single systemic common cold symptom scores over days 2-4 was calculated as (SSS2 + SSS3 + SSS4)/3 where SSS2, SSS3 and SSS4 are the systemic common cold symptom scores calculated for days 2, 3 and 4 respectively. SSS2-4 ranges from 0 (no symptoms) to 9 (severe symptoms)."|Days 2, 3 and 4|FAS||units on a scale||Standard Error|Least Squares Mean
13171|NCT01944631|Primary|Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms)."|Days 2, 3 and 4|Full analysis set (FAS) which included all randomised patients who used at least one dose of trial treatment, who provided a baseline total symptom score (TSS) as well as any post-treatment data for the primary endpoint.||units on a scale||Standard Error|Least Squares Mean
13172|NCT01944345|Secondary|Radiological Assessment|Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated|Post-operative follow up|26 (of 30) Cervical Patients 30 (of 39) Lumbar Patients||participants|||Number
13173|NCT01944345|Primary|Change in VAS Pain|"VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6.~VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means ‘no pain’ and a ten (10) means 'worst imaginable pain'"|Pre-operative and Post-operative 12 months|Total subjects: 30 Cervical subjects, 39 Lumbar subjects. VAS PAIN SEVERITY SCALE ranges from 0-10. Zero = no pain, 10 - worst imaginable pain||Units on a scale 0-10||Standard Deviation|Mean
13174|NCT01944345|Primary|Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50|ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability >34 Complete disability|Pre-operative and Post-operative 12 months post-operative|Combined cervical and lumbar patients: 30 cervical, 39 lumbar. Mean ODI/NDI was calculated for all patients at preop and 12 month.||Units on a scale 0-50||Standard Deviation|Mean
13175|NCT01944319|Secondary|Bacteriological Success Rate|"The bacterial success or failure will be evaluated at the end of meropenem therapy.~Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence."|At the end of meropenem therapy, an average of 10 days.|||participants|||Number
13176|NCT01944319|Secondary|Amount of Used Antibiotics|Record the amount of antibiotics usage during antibiotic therapy|participants will be followed for the duration of antibiotic therapy, an average of 10 days|||grams||Inter-Quartile Range|Median
13177|NCT01944319|Primary|Clinical Success Rate|"The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy.~Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy.~Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy."|One week after antibiotic therapy finished.|||participants|||Number
13178|NCT01944059|Secondary|HIT-6|Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.|||||
13179|NCT01944059|Secondary|Percent Change in Migraine and Headache Frequency|The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.|||||
13180|NCT01944059|Primary|Number of Migraine/Headache Days|The primary outcome measure will be the frequency of migraine and all headache days in the Theramine active group versus the Theramine placebo group during the treatment period.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.|||||
13181|NCT01943864|Secondary|Number of Participants With Independent Radiologist Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event. Only 1 participant reached PR therefore estimated time to response cannot be presented. At the data cut off, this patient is censored. Therefore, the observed value of duration of response is unknown.||Participants|||Number
13182|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event.||Participants|||Number
13419|NCT01940120|Other Pre-specified|Cardiac Output|Cardiac output as measured by core lab echocardiography.|30 Days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths within 30 days and in 6 patients Cardiac Output was not assessed or or un-evaluable.||l/min||Standard Deviation|Mean
13183|NCT01943864|Secondary|Number of Weeks Until Time to Response Assessed With Independent Radiologist|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.|Up to Week 37|ITT Population. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.||Weeks|||Number
13184|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Time to Response|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.|||||
13185|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Independent Radiologist Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Independent Radiologist assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.||Participants|||Number
13186|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Investigator Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Investigator assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.||Participants|||Number
13187|NCT01943864|Secondary|Number of Participants With Overall Survival|Overall Survival (OS) is defined as the interval of time (in weeks) between the date of randomization and the date of death due to any cause. For participants that did not die, time of death was censored at the date of last contact. The date of death was taken from that recorded on the Record of Death page. Death on study due to any cause was included. One year OS was calculated from Kaplan-Meier estimates.|Up to Week 39|ITT Population.||Participants|||Number
13188|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Independent Radiologist|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the independent radiologist. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.||Participants|||Number
13189|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Investigator|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the Investigator. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.||Participants|||Number
13190|NCT01943864|Secondary|Change From Baseline in Oxygen Saturation (SpO2)|Oxygen Saturation was measured at Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32 and Week 36. For records occurring after baseline, change from baseline was calculated as the post baseline value minus the baseline value. When either the baseline or visit value was missing, the change from baseline was considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Percent oxygen saturation||Standard Deviation|Mean
13191|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Pulse Rate|Pulse rate was categorized as Decrease to <60, Change to Normal or No Change, and Increase to >100. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13242|NCT01942785|Primary|Change From Baseline to Week 6 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13192|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure was measured after sitting for at least 5 minutes. Systolic blood pressure (SBP) was categorized as: Grade 0 (<120), Grade 1 (>=120-<140), Grade 2 (>=140-<160) and Grade 3 (>=160). Diastolic blood pressure (DBP) was categorized as Grade 0 (<80), Grade 1 (>=80-<90), Grade 2 (>=90-<100), and Grade 3 (>=100). Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13193|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Body Temperature|Body temperature was categorized as Decrease to <=35; Change to Normal or No Change and Increase to >=38. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13194|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Carcinoembryonic Antigen Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for carcinoembryonic antigen (CEA). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13195|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Hematology Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for basophils, eosinophils, and monocytes. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13196|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Prothrombin Time Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for prothrombin time (PT). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13197|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Clinical Chemistry Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for cancer antigen 19-9 (CA 19-9), chloride, lactate dehydrogenase (LDH), and urea. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13198|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for hemoglobin, lymphocytes, neutrophils, platelets, and leukocytes. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13283|NCT01942135|Secondary|Observed Plasma Trough Concentration (Ctrough) for Palbociclib|"Ctrough for palbociclib (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycle 1/Day 15 and Cycle 2/Day 15|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
13199|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Coagulation Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for activated partial thromboplastin time (APTT) and prothrombin time (PT). A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13200|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Clinical Chemistry Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for albumin, alkalaine phosphatase (AP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatine kinase (CK), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and phosphate. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Participants|||Number
13201|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker Surfactant Protein D|Interstitial lung disease marker Surfactant Protein D assessments were carried out at Baseline (Day 1), Week 12, and Week 28|Baseline, Week 12, and Week 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).||Micrograms per litre (µ/L)||Standard Deviation|Mean
13202|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker KL-6|Interstitial lung disease markers KL-6 assessments were carried out at Baseline (Day 1), Week 12, Week 20, Week 24, Week 28, Week 32, and Week 36|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed.||Units/milliliter (U/mL)||Standard Deviation|Mean
13203|NCT01943864|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or Protocol-Specific SAEs|until 26-Feb-2016|ITT Population.||Participants|||Number
13204|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Independent Radiologist Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Twelve week non-progressive disease (PD) at Week 12 was evaluated by computed tomography. Non- PD was calculated as the sum of complete response (CR), partial response (PR), and stable disease (SD).|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.||Participants|||Number
13205|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Investigator Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease(PD), At least a 20% increase in the sum of the diameters of target lesions. Non-PD = CR + PR + SD.|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.||Participants|||Number
13206|NCT01943552|Secondary|Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery|Number of patients with at least one main post-operative pulmonary complications (including pneumonia, atelectasis and acute respiratory failure) within three weeks after the surgery. Post-operative pneumonia was defined by the presence of the following criteria: persistent lung infiltrate on chest X-ray or chest computerized tomography (CT)-scan, white blood cell count >10,000 /mm3 and fever. Post-operative atelectasis was diagnosed by presence of atelectasis affecting one lobe or several lobes in chest X-ray test or chest CT-scan. Post-operative acute respiratory failure was defined by the presence of: PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg while breathing air or other evidences which were considered as respiratory failure by investigators.|From surgery to 3 weeks post surgery, up to 21 days|Surgery complete set (SCS): All patients who completed surgery.||Participants|||Number
13207|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial carbon dioxide pressure (PaCO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||mmHg||Standard Error|Least Squares Mean
13208|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): Oxygen saturation|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||Percentage of Oxygen||Standard Error|Least Squares Mean
15949|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Spatial QRS-T Angle|Compute maximum mean placebo, and baseline-adjusted change for: spatial QRS-T angle (degrees)|24 hours|||degrees||95% Confidence Interval|Least Squares Mean
13210|NCT01943552|Secondary|Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FVC were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At Visit 1, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At Visit 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FVC each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)||ml||Standard Error|Least Squares Mean
13211|NCT01943552|Primary|Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced expiratory volume in 1 second (FEV1) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FEV1 were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At screening visit, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At treatment day 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FEV1 each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS): All patients in the treated set who had observed analysable data in at least one efficacy endpoint. (Only patients with observed cases (OC) values were analysed)||ml||Standard Error|Least Squares Mean
13212|NCT01943344|Other Pre-specified|Performance|Assessed by technical success rate for the VIVASURE CLOSURE DEVICE™|up to 3 month of implantation||||||
13213|NCT01943344|Secondary|Minor Vascular Complications Directly Related to Device|Incidence of minor complications directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, as defined by VARC-2.|up to 3 months from implantation||||||
13214|NCT01943344|Primary|Major Vascular Complications Directly Related to Device|Incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2) is no worse than those associated with cut-down and sutured close.|up to 3 Months of implantation|||participants|||Number
13215|NCT01943292|Secondary|Evaluate the Efficacy (Response Rate and Progression-free Survival) of Subjects Treated With Defactinib (VS-6063).|Response rate and progression-free survival, as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1|Every 8 weeks up to end of treatment, an expected average of 12 weeks||||||
13216|NCT01943292|Secondary|Assess the Pharmacokinetics, Metabolism and Elimination of Defactinib (VS-6063) in Plasma and Urine.|PK parameters, including but not limited to plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2. Total 24-hour urine output will be collected in conjunction with PK sampling to assess the elimination of defactinib (VS-6063) and its potential metabolites.|Time points at Day 1 and Day 15 in Cycle 1||||||
13217|NCT01943292|Secondary|Define the Maximum Tolerated Dose (MTD), if Achieved, and Establish the Recommended Phase 2 Dose (RP2D) of Defactinib (VS-6063) in Japanese Subjects.|The RP2D will be determined based on the MTD of defactinib (VS-6063) as determined by number of participants with dose limiting toxicities (DLTs) related to defactinib.|From start of treatment to end of cycle 1 (21 day cycles)|||mg|||Number
13218|NCT01943292|Primary|Assess the Safety and Tolerability of Defactinib (VS-6063) in Japanese Subjects With Non-hematologic Malignancies|"A composite by dose level to include incidence of AEs, SAEs, dose interruptions and dose reductions as a measure of safety and tolerability. Abnormal Clinical significant laboratory results, ECG measurements, vital signs measurement, physical examination findings, and ECOG performance status were captured as adverse events.~The severity of AEs were evaluated according to CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03"|From start of treatment to end of treatment, an expected average of 12 weeks|||participants|||Number
13219|NCT01943110|Secondary|Proportion of Injections With Safety Events|The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|Within 30 minutes and within 48 hours of injection|||percentage of injections|Participants||Number
13220|NCT01943110|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.|1 day|||Injections|Participants||Number
13221|NCT01942785|Primary|CGI-I Score at Week 6 Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression - global improvement CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|full-analysis set (FAS)||units on a scale||Standard Error|Mean
13231|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - EDT DRT Score|DRT consists of 60 choices between an immediate reward or a higher delayed reward. The number of impulsive choices will be a continuous variable estimated from how many immediate choices based on 60 possible. The number ranges between 0 and 60, with a higher value indicating more impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.||units on a scale||Standard Error|Mean
13222|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)||units on a scale||Standard Error|Mean
13223|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Subgroup analyses were performed for the change from Baseline to Week 6 in MADRS total score based on the patients’ BIS-11 total score at Baseline. The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)||units on a scale||Standard Error|Mean
13224|NCT01942785|Primary|Change From Week 6 to Week 10 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
13225|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
13226|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
13227|NCT01942785|Primary|Change From Week 6 to Week 10 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provide information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis.||units on a scale||Standard Error|Mean
13228|NCT01942785|Primary|Change From Week 6 to Week 10 in Delay Discounting - MCQ Scores|The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provide an estimate of the patient’s discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.||log-transformed units on a scale||Standard Error|Mean
13229|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week, using verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.||units on a scale||Standard Error|Mean
13230|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The patient rates the extent to which they have suffered from these symptoms. Each subscale has verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. One additional question assesses number of days impaired by irritability over the period. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)||units on a scale||Standard Error|Mean
13232|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed EDT DPDT Scores|DPDT consists of approximately 110 choices between an immediate reward or a higher delayed reward, and between an immediate reward or a higher reward that only comes with a certain probability. The tasks are scored independently of each other and do not yield a total score. There will be two derived variables from this task; a delayed discounting rate and a probability discounting rate. The delay discounting value takes values from 0 and up, a higher delay discounting value indicates greater impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.||log transformed units on a scale||Standard Error|Mean
13233|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Total Score|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ consists of 92 items which form the basis for the four subscales: depression, anxiety, anger-hostility, and somatic; of which 68 items indicate symptoms (symptom subscales) and 24 items are antonyms of some of the symptoms and indicate well-being (well-being subscales). A “yes” or “true” response on the symptom subscales scores 1, and a “no” or “false” on the well-being subscales scores 1. The maximum score for each symptom subscale is 17, and the maximum score for each well-being subscale is 6. The score of each subscale ranges from 0 to 23 (the sum of the symptom subscale and the well-being subscale). A higher score indicates more distress. The total score ranges from 0 to 92. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13234|NCT01942785|Primary|CGI-I Score at Week 6|The Clinical Global Impression - global improvement CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|Full-analysis set (FAS), this endpoint presents descriptive statistics for CGI-I based on patients who have CGI-I score observed at Week 6; the number of participants analysed is therefore smaller than the defined FAS.||units on a scale||Standard Error|Mean
13235|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13236|NCT01942785|Primary|Change From Baseline to Week 6 in CPFQ Total Score|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13237|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13238|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13239|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Total Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 consists of 30 items assessing the symptoms of depression, as well as commonly associated symptoms (for example, anxiety, irritability), and topics relevant to melancholic or atypical features; the patient rates only one of the 2 items assessing appetite (decreased or increased), and only one of the 2 items assessing weight (loss or gain). Each of the items is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe). The total score is the sum of the 28 scored items, and ranges from 0 to 84, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13240|NCT01942785|Primary|Shift From Baseline to Week 6 in Anger Attacks (AAQ)|The Anger Attacks Questionnaire (AAQ) is a patient-rated scale designed to assess the presence of anger attacks over a period of time. The AAQ consists of 7 items. Patients are classified as having anger attacks when exhibiting the following 4 criteria: 1) irritability, 2) overreaction to minor annoyances, 3) occurrence of anger attacks (at least one of which occurred within the period), and 4) experienced 4 or more specific symptoms during at least one of the attacks. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS) and OC. Only patients who have both baseline and Week 6 data observed were included; the number of participants analysed is therefore smaller than the defined FAS.||participants|||Number
13907|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13243|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed MCQ Scores|The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provide an estimate of the patient’s discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||log-transformed units on a scale||Standard Error|Mean
13244|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Item 6 Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 item 6 measures mood (irritable) and is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe) with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13245|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13246|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
13247|NCT01942733|Primary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) assesses the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13248|NCT01942733|Primary|Change From Baseline to Week 8 in BRIAN Total Score|The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) is a clinician-rated scale designed to assess biological rhythms. The BRIAN consists of 18 items divided in 4 subscales: sleep (5 items), activity (5 items), social (4 items), and eating pattern (4 items). Each item is rated on a scale from 1 (no difficulties) to 4 (serious difficulties). The total score of the 18 items ranges from 18 to 72, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13249|NCT01942733|Primary|Changes From Baseline to Week 8 on Number of Awakenings (NAW) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number of events||Standard Error|Mean
13250|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Efficiency (SE) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of time||Standard Error|Mean
13251|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Actigraphy (ACT) Parameters|The key ACT parameters assessed were the total sleep time (ACT TST), wake-time after sleep onset (ACT WASO), sleep onset latency (ACT SOL), sleep efficiency (ACT SE), and the number of awakenings (ACT NAW). The results for ACT TST, ACT WASO, and ACT SOL are presented separately from ACT SE, and from ACT NAW, due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes||Standard Error|Mean
13284|NCT01942135|Secondary|Survival Probabilities at Months 12, 24 and 36|One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.|From randomization until death (assessed up to 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
13252|NCT01942733|Primary|Percentage of MADRS Remitters at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Remission was defined as a MADRS total score ≤10 and a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of patients|||Number
13253|NCT01942733|Primary|Percentage of MADRS Responders at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Response was defined as a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of patients|||Number
13254|NCT01942733|Primary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) scale assesses the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13255|NCT01942733|Primary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13256|NCT01942733|Primary|Changes From Baseline to Week 8 in Circadian and Biological Rhythm|The parameters used to assess circadian and biological rhythm were the time to peak cortisol concentration, time to dim-light melatonin onset (DLMO) and phase angle. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes||Standard Error|Mean
13257|NCT01942733|Primary|Change From Baseline to Week 8 in CPFQ Total Score|The Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13258|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s Scores (Noon)|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13259|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Morning) Score|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13260|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Evening) Score|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13261|NCT01942733|Primary|Changes From Baseline to Week 8 in Number of Lapses as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number||Standard Error|Mean
13262|NCT01942733|Primary|Changes From Baseline to Week 8 in Response Speed as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||speed (per second)||Standard Error|Mean
13263|NCT01942733|Primary|Change From Baseline to Week 8 on ESS Total Score|The Epworth Sleepiness Scale (ESS) is a is a patient-rated scale designed to measure daytime sleepiness. The ESS consists of 8 items describing different situations/activities and the patients rate the chance of them dozing off or falling asleep when they are in these situations. Each item is rated on a 4-point scale from 0 (would never dose) to 3 (high change of dozing). The total score of the 8 items ranges from 0 to 24, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13264|NCT01942733|Primary|Change From Baseline to Week 8 in ISI Total Score|The Insomnia Severity Index (ISI) is a patient-rated scale desgined to measure the patient’s perception of his/her insomnia. The ISI comprises 7 items: difficulty falling asleep, difficulty staying asleep, problems waking up early in the morning, satisfaction with current sleep pattern, interference with daily functioning, how much others notice the sleep problem impairs quality of life, and distress caused by the sleep problem. Each of the 7 items is rated on a 5-point scale from 0 (best situation) to 4 (worst situation). The total score of the 7 items ranges from 0 to 28, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||units on a scale||Standard Error|Mean
13265|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography (Continued)|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes||Standard Error|Mean
13266|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of total sleep duration||Standard Error|Mean
13267|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Number of Awakenings (NAW)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number||Standard Error|Mean
13268|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes (min)||Standard Error|Mean
13269|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Sleep Efficiency (SE)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage of time||Standard Error|Mean
13270|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Sleep Efficiency (PSG SE)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||percentage (%)||Standard Error|Mean
13271|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Number of Awakenings (PSG NAW)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||number of events||Standard Error|Mean
13272|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.||minutes (min)||Standard Error|Mean
13273|NCT01942135|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)|An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.|From the signing of the informed consent until 28 days after the last dose of study medication up to 14 months|The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.||Percentage of Participants|||Number
13274|NCT01942135|Secondary|Time to Deterioration (TTD)|A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.|Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment.||Months||95% Confidence Interval|Median
13275|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
13372|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ratio||Standard Deviation|Geometric Mean
13276|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/ impairment Published weights are available that allow for the creation of a single summary score called the EQ-5D index, which basically ranges from 0 to 1 with low scores representing a higher level of dysfunction and 1 as perfect health. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
13277|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from ’not at all’ to ’very much’. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
13278|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from ’not at all’ to ’very much’. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
13279|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores|The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from “not at all” to “very much” and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
13280|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores|The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from “not at all” to “very much” and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Units on a scale||95% Confidence Interval|Mean
13281|NCT01942135|Secondary|Ctrough for Goserelin|"Cmin for goserelin (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/ Day 1 and Cycle 3/ Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
13282|NCT01942135|Secondary|Ctrough for Fulvestrant|"Ctrough for Fulvestrant (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/Day 1 and Cycle 3/Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
13394|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|4 year|||participants|||Number
13285|NCT01942135|Secondary|Clinical Benefit Response (CBR)|CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.||percentage of participants||95% Confidence Interval|Number
13286|NCT01942135|Secondary|Duration of Response (DR)|DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) – first CR or PR date + 1)]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
13287|NCT01942135|Secondary|Objective Response (OR)|OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (OR) = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.||percentage of participants||95% Confidence Interval|Number
13288|NCT01942135|Secondary|Overall Survival (OS) - Number of Participants Who Died|OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = [death date (censor date) – randomization date + 1]/30.4. No inferential statistical analysis were done because of the immaturity of the OS data.|From randomization until death (up to approximately 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||deaths|||Number
13289|NCT01942135|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.|From randomization date to date of first documentation of progression or death (assessed up to 12 months)|The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
13290|NCT01941940|Secondary|Mean Soluble Interleukin-6 Receptor (sIL-6R) Concentration||Baseline, Weeks 12, 24, 38, 52, and at 8 weeks after last dose (up to Week 60)||06/2017||||
13291|NCT01941940|Secondary|Mean Tocilizumab Concentration||Baseline, Weeks 12, 24, 38, 52, and at 8 weeks after last dose (up to Week 60)||07/2017||||
13292|NCT01941940|Secondary|Percentage of Participants With Anti-drug Antibodies (ADA) to Tocilizumab||Baseline, Weeks 12, 24, 38, 52, and at 8 weeks after last dose (up to Week 60)||07/2017||||
13293|NCT01941940|Secondary|Percentage of Participants Who Were Treatment Compliant, as Assessed Using Participant Diary Cards and Return Records||Weeks 24 and 52||07/2017||||
13395|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|3 year|||participants|||Number
13396|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|24 months|||participants|||Number
13294|NCT01941940|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Weeks 24 and 52|PSQI is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). A participant indicates how frequently each item was experienced on a scale from 0 to 3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality. A score of >/=5 indicates poor sleepers.|Baseline, Weeks 24 and 52||07/2017||||
13295|NCT01941940|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Weeks 24 and 52|The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Weeks 24, and 52||07/2017||||
13296|NCT01941940|Secondary|Short Form-Health and Labor Questionnaire (SF-HLQ) Score at Weeks 24 and 52||Weeks 24 and 52||07/2017||||
13297|NCT01941940|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52|HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 24 and 52||07/2017||||
13298|NCT01941940|Secondary|Participant Pain VAS Score at Weeks 2, 24, and 52|Participant's assessed pain using a 0-100 mm VAS. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Weeks 2, 24, and 52||07/2017||||
13299|NCT01941940|Secondary|Change From Baseline in PGDA VAS Score at Weeks 2, 24, and 52|The physician assessed participant's current disease activity on a 0-100 mm VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity.|Baseline, Weeks 2, 24, and 52||07/2017||||
13300|NCT01941940|Secondary|Change From Baseline in PtGDA VAS Score at Weeks 2, 24, and 52|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 millimeter (mm) VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Weeks 2, 24, and 52||07/2017||||
13301|NCT01941940|Secondary|Percentage of Participants With Reasons for Non-DMARDs Dose Reductions and/or Discontinuation||Baseline up to Week 52||07/2017||||
13302|NCT01941940|Secondary|Percentage of Participants With Reasons for DMARDs Dose Reductions and/or Discontinuation||Baseline up to Week 52||07/2017||||
13303|NCT01941940|Secondary|Change From Baseline in Total SJC at Weeks 2, 24, and 52|SJC was defined as the total number of swollen joints based on a 28-joint assessment.|Baseline, Weeks 2, 24, and 52||07/2017||||
13304|NCT01941940|Secondary|Change From Baseline in Total TJC at Weeks 2, 24, and 52|TJC was defined as the total number of painful joints based on a 28-joint assessment.|Baseline, Weeks 2, 24, and 52||07/2017||||
13305|NCT01941940|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS-28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 </=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1; non-responders: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1.|Weeks 2, 24, and 52||07/2017||||
13306|NCT01941940|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|The ACR 20, 50, and 70 responses: greater than or equal to (>/=) 20 percent (%), 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at each visit.|Weeks 2, 24, and 52||07/2017||||
13307|NCT01941940|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 24, and 52|SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and C-reactive protein (CRP) in milligrams per deciliter (mg/dL). Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Baseline, Weeks 2, 24, and 52||07/2017||||
13308|NCT01941940|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Weeks 2, 24, and 52|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affection due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR </=3.2 indicates low disease activity, DAS28-ESR >3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR </=3.2 indicates remission.|Baseline, Weeks 2, 24, and 52||07/2017||||
13309|NCT01941940|Secondary|Percentage of Participants Achieving Clinical Remission According to CDAI at Week 52|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission.|Week 52||07/2017||||
13310|NCT01941940|Primary|Change From Baseline in CDAI at Week 2|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 2|FAS; Here, number of participants analyzed indicates participants who were evaluable for this outcome.||units on a scale||Standard Deviation|Mean
13311|NCT01941940|Primary|Change From Baseline in CDAI at Week 4|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 4|FAS; Here, number of participants analyzed indicates participants who were evaluable for this outcome.||units on a scale||Standard Deviation|Mean
13312|NCT01941940|Primary|Change From Baseline in CDAI at Week 8|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 8|FAS; Here, number of participants analyzed indicates participants who were evaluable for this outcome.||units on a scale||Standard Deviation|Mean
13313|NCT01941940|Primary|Change From Baseline in CDAI at Week 12|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 12|FAS; Here, number of participants analyzed indicates participants who were evaluable for this outcome.||units on a scale||Standard Deviation|Mean
13314|NCT01941940|Primary|Change From Baseline in CDAI at Week 16|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 16|FAS; Here, number of participants analyzed indicates participants who were evaluable for this outcome.||units on a scale||Standard Deviation|Mean
13315|NCT01941940|Primary|Change From Baseline in CDAI at Week 20|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 20|FAS; Here, number of participants analyzed indicates participants who were evaluable for this outcome.||units on a scale||Standard Deviation|Mean
13316|NCT01941940|Primary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient's global assessment of disease activity (PtGDA) and physician global assessment of disease activity (PGDA) assessed on 0-10 centimeter (cm) visual analogue scale (VAS). Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score less than or equal to (</=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 24|FAS; Here, number of participants analyzed indicates participants who were evaluable for this outcome.||units on a scale||Standard Deviation|Mean
13317|NCT01941615|Primary|C24,ss of Levonogestrel|Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
13318|NCT01941615|Primary|Cmax,ss of Levonogestrel|Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
13319|NCT01941615|Primary|AUCtau,ss of Levonogestrel|Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
13320|NCT01941615|Primary|C24,ss of Ethinylestradiol|Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
13321|NCT01941615|Primary|Cmax,ss of Ethinylestradiol|Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
13397|NCT01940120|Other Pre-specified|Incidence of Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|12 months|||participants|||Number
13930|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13322|NCT01941615|Primary|AUCtau,ss of Ethinylestradiol|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.|||||
13323|NCT01941498|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature was assessed by a commercially available system and measured in diopters.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||diopter||Standard Deviation|Mean
13324|NCT01941498|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Baseline (Day 0), Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.||microns||Standard Deviation|Mean
13325|NCT01941498|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity.|Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|"This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. Here, n is the number of subjects assessed uncorrected."||logCS||Standard Deviation|Mean
13326|NCT01941498|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
13327|NCT01941498|Secondary|"Percent Response by Category: My Vision Is a Concern in My Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
13328|NCT01941498|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
13329|NCT01941498|Secondary|"Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore..."|As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
13330|NCT01941498|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||units on a scale||Standard Deviation|Mean
13331|NCT01941498|Secondary|Mean Total Laser Treatment Time|Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.||seconds||Standard Deviation|Mean
13332|NCT01941498|Secondary|Mean Laser Treatment Time|Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.||seconds||Standard Deviation|Mean
13333|NCT01941498|Secondary|Mean Manifest Refraction (Cylinder)|Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||diopter|Participants|Standard Deviation|Mean
13334|NCT01941498|Secondary|Mean Manifest Refraction (Sphere)|Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||diopter|Participants|Standard Deviation|Mean
13398|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|4 year|Of 78 total population, 31 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 8 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
13335|NCT01941498|Secondary|Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||microns||Standard Deviation|Mean
13336|NCT01941498|Primary|Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA|Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.|Month 1|This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.||logMAR||Standard Error|Least Squares Mean
13337|NCT01941485|Secondary|Corneal Topography: Angles|The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||degrees|Eyes|Standard Deviation|Mean
13338|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Depth|The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||millimeters|Eyes|Standard Deviation|Mean
13339|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Volume|The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||millimeters cubed|Eyes|Standard Deviation|Mean
13340|NCT01941485|Secondary|Corneal Topography: Q-value|The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (−1 < Q < 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q > 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."||unit less|Eyes|Standard Deviation|Mean
13341|NCT01941485|Secondary|Flap Creation Time as Documented in the Log Files|The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||seconds||Standard Deviation|Mean
13342|NCT01941485|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature as assessed by a commercially available system and measured in diopters.|Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||diopter||Standard Deviation|Mean
13343|NCT01941485|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||percentage of subjects|||Number
13344|NCT01941485|Secondary|"Percent Response by Category: My Vision is a Concern in my Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of subjects|||Number
13345|NCT01941485|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of subjects|||Number
13346|NCT01941485|Secondary|"Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.||percentage of subjects|||Number
13347|NCT01941485|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||units on a scale||Standard Deviation|Mean
39492|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)||||||
13348|NCT01941485|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||micrometers||Standard Deviation|Mean
13349|NCT01941485|Secondary|Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)|The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.|Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||millimeters||Standard Deviation|Mean
13350|NCT01941485|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. Both eyes contributed to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||logCS||Standard Deviation|Mean
13351|NCT01941485|Secondary|Manifest Refraction (Cylinder)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||Diopters|eyes|Standard Deviation|Mean
13352|NCT01941485|Secondary|Manifest Refraction (Sphere)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||Diopters|Eyes|Standard Deviation|Mean
13353|NCT01941485|Secondary|Best Corrected Visual Acuity (BCVA)|VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||logMAR||Standard Deviation|Mean
13354|NCT01941485|Secondary|Uncorrected Visual Acuity (UCVA)|Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||logMAR||Standard Deviation|Mean
13355|NCT01941485|Secondary|The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively|The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Month 1 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.||microns||Standard Deviation|Mean
13356|NCT01941485|Secondary|Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap|The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of flap||Standard Deviation|Mean
13357|NCT01941485|Secondary|Incidence of Development of Opaque Bubble Layer (OBL)|OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||percentage of participants|||Number
13358|NCT01941485|Primary|The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Day 1 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.||microns||Standard Deviation|Mean
13399|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|3 year|Of 78 total population, 36 participants were included in analysis population because of 31 deaths within 2 years, 7 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
13359|NCT01941186|Other Pre-specified|Acceptability of the Patient Decision Aid for Early Intervention Referral|The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.|Up to 7 days|"Provider information was not collected as outlined in the initial protocol design. All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. This includes elements of parent acceptability. A separate analysis was not completed."|||||
13360|NCT01941186|Other Pre-specified|Feasibility of the Patient Decision Aid|The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.|Up to 7 days|Data was not collected regarding the time to complete PDA and/or number of Early Intervention referrals for the total population, thus data for this outcome measure was not able to be analyzed as outlined at the time of protocol development.|||||
13361|NCT01941186|Other Pre-specified|Parental Predisposition for Early Intervention|Parental predisposition for early intervention services will be measured using surveys.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."|||||
13362|NCT01941186|Other Pre-specified|Parent Uncertainty About Early Intervention|Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."|||||
13363|NCT01941186|Secondary|Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention|Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.|Up to 7 days|All parent-child dyads who were enrolled and randomized were included in the analysis.||percentage of participants|||Number
13364|NCT01941186|Primary|Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups|Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.|Up to 1 year after randomization|One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation.||participants|||Number
13365|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||nmol/L||Standard Deviation|Mean
13366|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the molar plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||nmol*hour/L||Standard Deviation|Mean
13367|NCT01940510|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||liters||Standard Deviation|Mean
13368|NCT01940510|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||liters/hour||Standard Deviation|Mean
13369|NCT01940510|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||hours||Standard Deviation|Mean
13370|NCT01940510|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib and RO5468924|The Tmax is the time from alectinib administration to reach Cmax for alectinib and RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||hours||Full Range|Median
13371|NCT01940510|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib and RO5468924|AUC(0-last) is the area under the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) plasma concentration time-curve from time zero to the last measured concentration. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng*hour/mL||Standard Deviation|Mean
39493|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|26 week follow up||||||
13373|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ratio||Standard Deviation|Geometric Mean
13374|NCT01940510|Secondary|Cmax of RO5468924|Cmax is the maximum observed RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration, presented in ng/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng/mL||Standard Deviation|Mean
13375|NCT01940510|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng*hour/mL||Standard Deviation|Mean
13376|NCT01940510|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed alectinib plasma concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set||ng/mL||Standard Deviation|Mean
13377|NCT01940510|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|The Pharmacokinetic (PK) analysis set included all participants who received both scheduled doses of alectinib (on Day 1 and Day 17), and provided adequate PK assessments.||ng*hour/mL||Standard Deviation|Mean
13378|NCT01940484|Secondary|Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert|Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.|Up to 6 months|Due to observational nature of the study, the data for this outcome measure could not be collected.|||||
13379|NCT01940484|Secondary|Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta|Dose adjustment included dose increase or dose decrease with respect to previous visit’s dose.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)|Included all enrolled participants who were evaluable for this outcome measure.||participants|||Number
13380|NCT01940484|Secondary|Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study||Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)|"Included all enrolled participants who were evaluable for this outcome measure and n represents number of participants evaluable at the specified time point."||mcg||Standard Deviation|Mean
13381|NCT01940484|Primary|Mean Hemoglobin Value at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
13382|NCT01940484|Primary|Mean Hemoglobin Value at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
13383|NCT01940484|Primary|Mean Hemoglobin Value at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
13384|NCT01940484|Primary|Mean Hemoglobin Value at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
13385|NCT01940484|Primary|Mean Hemoglobin Value at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
13386|NCT01940484|Primary|Mean Hemoglobin Value at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||g/dL||Standard Deviation|Mean
13387|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
13388|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
13389|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
13390|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
13391|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
13392|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.||participants|||Number
13393|NCT01940146|Primary|Change in Total Nasal Symptom Score From Baseline to Day 14.|The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.|Baseline to Day 14|||units on a scale||Standard Error|Least Squares Mean
13401|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.||mmHg||Standard Deviation|Mean
13402|NCT01940120|Other Pre-specified|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|30 days|Of 78 total population, 69 participants were included in the analysis population because of 6 deaths within 30 days and in 3 participants Mitral Valve Gradient was not done or un-evaluable.||mmHg||Standard Deviation|Mean
13403|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral Valve Area evaluation was not done or un-evaluable||cm^2/m^2||Standard Deviation|Mean
13404|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral Valve Area evaluation was not done or un-evaluable.||cm^2/m^2||Standard Deviation|Mean
13405|NCT01940120|Other Pre-specified|Mitral Valve Area Index: by Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by planimetry was not done in 22 patients.||cm^2/m^2||Standard Deviation|Mean
13406|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 40 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Area evaluation was not done or un-evaluable||cm^2/m^2||Standard Deviation|Mean
13407|NCT01940120|Other Pre-specified|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Area evaluation was not done or un-evaluable||cm^2/m^2||Standard Deviation|Mean
13408|NCT01940120|Other Pre-specified|Mitral Valve Area Index: by Pressure-Half Time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|30 days|Of 78 total population, 65 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by pressure half-time was not done in 7 patients.||cm^2/m^2||Standard Deviation|Mean
13409|NCT01940120|Other Pre-specified|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
13410|NCT01940120|Other Pre-specified|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
13411|NCT01940120|Other Pre-specified|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths and in 6 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
13412|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|4 year|Of 78 total population, 18 participants were included in analysis population because of 33 deaths within 4 years, 8 withdrawals, 3 missed visit and in 16 patients Mitral Valve Area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
13413|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|3 year|Of 78 total population, 25 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 14 patients mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
13414|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
13415|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.||cm^2||Standard Deviation|Mean
13416|NCT01940120|Other Pre-specified|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.||cm^2||Standard Deviation|Mean
13417|NCT01940120|Other Pre-specified|Cardiac Output|Cardiac output as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Cardiac output evaluation was not done or un-evaluable.||l/min||Standard Deviation|Mean
13931|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13420|NCT01940120|Other Pre-specified|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients cardiac index evaluation was not done or un-evaluable.||l/min/m2||Standard Deviation|Mean
13421|NCT01940120|Other Pre-specified|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac Index evaluation was not done or un-evaluable.||l/min/m2||Standard Deviation|Mean
13422|NCT01940120|Other Pre-specified|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|30 Days|Of 78 total population, 66 participants were included in the analysis population because of 6 deaths within 30 days and in 6 participants cardiac Index was un-evaluable or not done.||l/min/m2||Standard Deviation|Mean
13423|NCT01940120|Other Pre-specified|Mitral Valve Index|Mitral valve index (mitral valve area divided by body surface area) as measured by core lab echocardiography.|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve index evaluation was not done or un-evaluable.||ratio||Standard Deviation|Mean
13424|NCT01940120|Other Pre-specified|Mitral Valve Index|Mitral valve index (mitral valve area divided by body surface area) as measured by core lab echocardiography.|30 days|Of 78 total population, 50 participants were included in the analysis population because of 6 deaths within 30 days and in 22 participants Mitral valve index was not done or un-evaluable.||ratio||Standard Deviation|Mean
13425|NCT01940120|Other Pre-specified|Incidence of New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|12 months|49 patients not on coumadin at baseline are included in the analysis.||participants|||Number
13426|NCT01940120|Other Pre-specified|Incidence of New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|6 months|49 patients not on coumadin at baseline are included in the analysis.||participants|||Number
13427|NCT01940120|Other Pre-specified|Incidence of New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|30 days|49 patients not on coumadin at baseline are included in the analysis.||participants|||Number
13428|NCT01940120|Other Pre-specified|Hospital Re-Admissions for Congestive Heart Failure (CHF)|Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.|12 months|3 patients who died prior to discharge not included.||events|||Number
13429|NCT01940120|Other Pre-specified|Number of Days Re-hospitalized for CHF|Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.|12 months|12/75 hospitalized for CHF post-discharge, representing 22 separate hospitalization events with mean of 6.6+/-3.7 days.||days||Standard Deviation|Mean
13430|NCT01940120|Other Pre-specified|Incidence of Discharge to a Nursing Home or Skilled Nursing Facility|Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.|30 Days|||participants|||Number
13431|NCT01940120|Other Pre-specified|Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time|Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.|Length of ICU/CCU stay, assessed at 30 Days|||hours||Standard Deviation|Mean
13432|NCT01940120|Other Pre-specified|Post-procedure Length of Hospital Stay|Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.|Length of Hospital Stay, assessed at 30 days|||days||Standard Deviation|Mean
13433|NCT01940120|Secondary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and NYHA was not assessed in 3 patients.||participants|||Number
13434|NCT01940120|Secondary|MR Severity||4 year|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and MR severity was not done or un-evaluable in 3 patients.||participants|||Number
13435|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|4 year|||participants|||Number
13436|NCT01940120|Secondary|Freedom From All Cause Mortality||4 years|Analysis population includes 31 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 48 months.||participants|||Number
13437|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment|Device Embolization or Single Leaflet Device Attachment between 3 year-4 year|4 years|Patients implanted with a MitraClip device and alive were evaluated at 48 months.||participants|||Number
13438|NCT01940120|Secondary|MR Severity||3 year|Of 78 total population, 37 participants were included in the analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and MR Severity was not done or un-evaluable in 2 patients.||participants|||Number
13439|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|3 year|||participants|||Number
13932|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13440|NCT01940120|Secondary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|Of 78 total population, 37 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.||participants|||Number
13441|NCT01940120|Secondary|Freedom From Death and Mitral Valve Surgery||3 years|Analysis population includes 40 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.||participants|||Number
13442|NCT01940120|Secondary|Freedom From Mitral Valve Surgery||36 months|Analysis population includes 40participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.||participants|||Number
13443|NCT01940120|Secondary|Freedom From All Cause Mortality||3 years|Analysis population includes 39 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.||participants|||Number
13444|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment||3 years|Patients implanted with a MitraClip device, alive were evaluated at 36 months.||participants|||Number
13445|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment|Device Embolization or Single Leaflet Device Attachment between 12 months-24 months|24 months|Patients implanted with a MitraClip device, alive were evaluated at 24 months.||participants|||Number
13446|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|24 months|||participants|||Number
13447|NCT01940120|Secondary|Freedom From Death and Mitral Valve Surgery||24 months|Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.||participants|||Number
13448|NCT01940120|Secondary|Freedom From Mitral Valve Surgery||24 months|Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.||participants|||Number
13449|NCT01940120|Secondary|Mitral Valve Repair Success|Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.|24 months|Three APS patients withdrew at or before 12 months, and had MR ≤ 2+ at all visits prior to withdrawal. Since there is no data on these patients post-12 months, these patients are not included in the endpoint of freedom from mitral valve replacement surgery for Valve Dysfunction, death and MR > 2+ at 24 months.||participants|||Number
13450|NCT01940120|Secondary|Regurgitant Fraction|Regurgitant fraction as measured by the core echocardiographic laboratory at follow-up.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant fraction assessment.||percent||Standard Deviation|Mean
13451|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant Volume assessment.||mL||Standard Deviation|Mean
13452|NCT01940120|Secondary|Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|24 months|Through 24 months, the clinical durability status of 3 patients is unknown and there were 35 patients with an acute reduction in MR severity from baseline of at least one grade (the one patient who underwent surgery between 12 months and 24 months is not included in the 35 patients).||participants|||Number
13453|NCT01940120|Secondary|Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|24 months|At 24 months, of the 56 patients who achieved acute procedural success, the status of 3 patients is unknown. Among the remaining 53 patients, 30 patients (56.6%) were alive and free from MR > 2+ at 24 months.||participants|||Number
13454|NCT01940120|Secondary|Freedom From All Cause Mortality||24 months|Analysis population 46 represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.||participants|||Number
13455|NCT01940120|Secondary|MR Severity||24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and NYHA not assessed in 2 patients.||participants|||Number
13456|NCT01940120|Secondary|Mortality Rate||24 months|||participants|||Number
13457|NCT01940120|Secondary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function: Left Ventricular Internal Dimension, Diastole (LVIDd), Left Ventricular Internal Dimension, Systole (LVIDs)|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and LVIDd/LVIDs not done or un-evaluable in 2 patients.||cm||Standard Deviation|Mean
13475|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant volume evaluation was not done or not evaluable.||mL||Standard Deviation|Mean
13476|NCT01940120|Secondary|Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|12 months|||participants|||Number
13458|NCT01940120|Secondary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|Of 78 total population, 43 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 1 patient without NYHA Class assessment.||participants|||Number
13459|NCT01940120|Secondary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function: Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|24 months|Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVEDV/LVESV was not done or un-evaluable in 5 patients.||mL||Standard Deviation|Mean
13460|NCT01940120|Secondary|Device Embolization or Single Leaflet Device Attachment|Device Embolization or Single Leaflet Device Attachment between day 0- 12 months|12 months|Three patients were excluded from the analysis as they did not receive a Device.||participants|||Number
13461|NCT01940120|Secondary|Freedom From Death and Mitral Valve Surgery||12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from death and mv surgery analysis at 12 months.||participants|||Number
13462|NCT01940120|Secondary|Composite Functional and Structural Measures - Freedom From Death and MR >2+|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|24 months|||percentage of participants||95% Confidence Interval|Number
13463|NCT01940120|Secondary|Composite Functional and Structural Measures - Freedom From Death|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR > 2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|24 months|Analysis population includes 46 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 24 months.||participants||95% Confidence Interval|Number
13464|NCT01940120|Secondary|Freedom From Mitral Valve Surgery||12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from MV surgery analysis at 12 months.||participants|||Number
13465|NCT01940120|Secondary|Freedom From All Cause Mortality||12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 12 months.||participants|||Number
13466|NCT01940120|Secondary|MR Severity||12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and MR Severity not done or un-evaluable in 2 patients.||participants|||Number
13467|NCT01940120|Secondary|Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.|12 months|||participants|||Number
13468|NCT01940120|Secondary|Mortality Rate||12 months|||participants|||Number
13469|NCT01940120|Secondary|Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|12 months|||participants|||Number
13470|NCT01940120|Secondary|MAE in Patients Over 75 Years of Age|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months|Analysis population includes 48 patients who were aged 75 years or older in the study.||participants|||Number
13471|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arterial-venous fistula;~Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;~Vascular surgical repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|12 months|||participants|||Number
13472|NCT01940120|Secondary|Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|12 months|||participants|||Number
13473|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|12 months|Total 78 participants, 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.||participants|||Number
13474|NCT01940120|Secondary|Regurgitant Fraction|Regurgitant fraction as measured by the core echocardiographic laboratory at follow-up.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant fraction evaluation was not done or not evaluable.||percent||Standard Deviation|Mean
13478|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months|||participants|||Number
13479|NCT01940120|Secondary|Non-cerebral Thromboembolism||12 months|||participants|||Number
13480|NCT01940120|Secondary|Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|12 months|There were 62 patients with an acute reduction in MR severity of at least one grade, and of these, 43 patients met the criterion for clinical durability. The clinical durability rate is therefore 43/62, or 69.4%.||participants|||Number
13481|NCT01940120|Secondary|Mitral Valve Repair Success|Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.|12 months|||participants|||Number
13482|NCT01940120|Secondary|Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|12 months|Of 78 total population, 56 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals and 1 missed visit.||participants|||Number
13483|NCT01940120|Secondary|Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|12 months|||participants|||Number
13484|NCT01940120|Secondary|Mortality||12 months|||participants|||Number
13485|NCT01940120|Secondary|MR Severity||Discharge|Analysis population includes 75 individuals as 3 patients died before discharge.||participants|||Number
13486|NCT01940120|Secondary|Procedural Freedom From In-hospital MAE|Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.|30 Days|||participants|||Number
13487|NCT01940120|Secondary|Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms|30 days|||participants|||Number
13488|NCT01940120|Secondary|Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|30 days|||participants|||Number
13489|NCT01940120|Secondary|Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|30 days|Of 78 total population, 72 were analyzed as 6 deaths within 30 days.||participants|||Number
13490|NCT01940120|Secondary|High Risk Procedural Success|Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.|30 days|||participants|||Number
13491|NCT01940120|Secondary|Regurgitant Fraction|Regurgitant fraction as measured by the core echocardiographic laboratory at follow-up.|30 days|Of 78 total population, 58 participants were analysed as 6 participants died within 30 days and 14 missing data (not done or not evaluable).||percent||Standard Deviation|Mean
13492|NCT01940120|Secondary|Clip Implant Rate|Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.|30 Days|||participants|||Number
13493|NCT01940120|Secondary|Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|30 days|||participants|||Number
13494|NCT01940120|Secondary|Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|30 days|||participants|||Number
13495|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|30 days|Of 78 total population, 58 participants were included in the analysis population because of 6 deaths within 30 days and 14 missing data (not done or not evaluable).||mL||Standard Deviation|Mean
13496|NCT01940120|Secondary|MAE in Patients Over 75 Years of Age|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|Analysis population includes 48 patients who were aged 75 years or older in the study.||participants|||Number
13497|NCT01940120|Secondary|Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|30 days|||participants|||Number
13498|NCT01940120|Secondary|Endocarditis|Clinical Event Committee (CEC)-adjudicated diagnosis of endocarditis based on the Duke criteria.|30 days|||participants|||Number
13499|NCT01940120|Secondary|Non-cerebral Thromboembolism||30 days|||participants|||Number
13500|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arterial-venous fistula;~Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;~Vascular surgical repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|30 days|||participants|||Number
13501|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events (MAE)|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|||participants|||Number
13933|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13502|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.||events|||Number
13503|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.||participants|||Number
13504|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function - Internal Dimension|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.||cm||Standard Deviation|Mean
13505|NCT01940120|Primary|Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function - End Diastolic/Systolic Volume|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV/LVESV was not done or un-evaluable in 2 patients.||mL||Standard Deviation|Mean
13506|NCT01940120|Primary|Composite Functional and Structural Measures - Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36|Standardized QOL surveys allow physicians to evaluate the effectiveness of various treatment methods & the physical & psychological benefits a patient is likely to receive from a particular treatment. In the EVEREST trial, patients were asked to complete the SF-36 QOL survey & the physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale. For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively. Scores between these values represent the % of the total possible score achieved. The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.|12 months|Of 78 total population, 51 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and SF-36 not done in 5 patients.||score on a scale||Standard Deviation|Mean
13507|NCT01940120|Primary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.||participants|||Number
13508|NCT01940120|Primary|Composite Functional and Structural Measures - Freedom From Death and MR >2+|"The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and MR >2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, QOL as measured by Short Form (SF) 36, re-hospitalizations for CHF and LV function.~The primary analysis cohort for the High Risk Registry, was the Intention to Treat population (all 78 subjects). The worst case analysis assumes that for any type of missing data, the Device group is assigned the failure value and the Control group is assigned the success value. In the worst case analysis for the HRR, there were only the Device group Intention to Treat patients, so only the preceding descriptions for the Device patient would apply."|12 months|||participants||95% Confidence Interval|Number
13509|NCT01940120|Primary|Composite Functional and Structural Measures - Freedom From Death|The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including: freedom from death at 12-months, freedom from death and mitral regurgitation (MR) > 2+ at 12-months, and clinical measures of benefit at 12-months, including: New York Heart Association (NYHA) Class, Quality of Life (QOL) as measured by Short Form (SF) 36, re-hospitalizations for congestive heart failure (CHF) and left ventricular (LV) function.|12 months|||participants||95% Confidence Interval|Number
13521|NCT01939548|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, lipids, electrolytes, hormones (prolactin), clinical chemistry, and urinalysis (dipstick and microscopy).|Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only)|All participants who had received at least 1 dose of study drug and who were evaluable for laboratory abnormalities.||participants|||Number
13510|NCT01940120|Primary|Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.||participants|||Number
13511|NCT01940120|Primary|Mortality|The endpoint is the actual observed procedural mortality of the intent to treat clip population versus this population's predicted procedural mortality, per the Society of Thoracic Surgeons (STS) risk calculator. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to predicted mitral valve surgery safety.|30 days|||participants|||Number
13512|NCT01939548|Secondary|Concentration of PF-02545920 and Its Metabolite, PF-01001252|Pharmacokinetic (PK) samples were collected at varying times relative to drug dosing whenever participants could be scheduled for study visits (sparse PK sampling). Thus, because of the variable time between the last dose and the collection of the PK samples, typical summary PK analyses were not planned or described in the study protocol and are not available. The study protocol analysis section specified that the sparse sampled PK data might be pooled with PK data from previous PF-02545920 clinical studies, however the study results did not support conducting those analyses.|Days 14, 28, 42, 56, 70, 84/Early Termination|Summary PK analyses were not planned or performed due to sparse PK sampling.|||||
13513|NCT01939548|Secondary|Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS assessed whether participant experienced the following: completed suicide (Category 1), suicide attempt (Category 2; response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Category 3; “Yes” on “preparatory acts or behavior”), suicidal ideation (Category 4; “Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (Category 7; “Yes” on “Has subject engaged in non-suicidal self-injurious behavior”).|Baseline up to 7-10 days after last dose of study drug|All participants who had received at least 1 dose of study drug.||participants|||Number
13514|NCT01939548|Secondary|Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period|The MDBS-D quantified the dystonia burden during the active treatment period. For an individual participant, MDBS-D took into account all treatment-emergent dystonia events and was defined as a combination of the severity of the AE due to dystonia, AE duration, prescribed concomitant medication, and the total number of days the study treatment was received. Scores for the MDBS-D ranged from 0 (no dystonia events) to 4.5, with higher scores indicating greater dystonia burden.|Active treatment period (Weeks 1 to 12/Early Termination)|All participants who received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
13515|NCT01939548|Secondary|Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale‑Abbreviated (ESRS‑A)|The ESRS-A is a 28-item instrument designed to facilitate standardized observations of parkinsonism, dystonia, dyskinesia, and akathisia. Ratings were determined through a combination of clinical interview and a motor examination. Scores were divided into individual domain scores and clinical global impression scores (CGI-S). Scores started from 0 (normal) to 6 (0 to 8 for CGI-S), with higher scores indicating greater severity.|Baseline, Week 12|All participants who received at least 1 dose of study drug. n=number of evaluable participants for each parameter at the specified time points.||units on a scale||Standard Deviation|Mean
13516|NCT01939548|Secondary|Change From Baseline in Prolactin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||nanogram (ng)/milliliter||Standard Deviation|Mean
13517|NCT01939548|Secondary|Change From Baseline in Insulin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||micro international unit/milliliter||Standard Deviation|Mean
13518|NCT01939548|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||percent||Standard Deviation|Mean
13519|NCT01939548|Secondary|Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12|Choleseterol, TG, glycosylated hemoglobin (HbA1c), LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
13520|NCT01939548|Secondary|Number of Participants With Extrapyramidal Motor System (EPS) AEs|EPS AEs consisted of oromandibular dystonia, extrapyramidal disorder, akathisia, dyskinesia, and tremor.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.||participants|||Number
15915|NCT01875471|Primary|Subjective Ease of Lens Removal|After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).|Day 7|||participants|||Number
13522|NCT01939548|Secondary|Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.|Baseline and Week 12 or Early Termination|All participants who received at least 1 dose of study drug and who were evaluable for physical examinations.||participants|||Number
13523|NCT01939548|Secondary|Number of Participants With Weight Change >=7%|The effects of PF-02545920 on body weight were evaluated. The number of participants with changes from baseline in body weight of >=7% were tabulated and summarized.|Screening up to Day 84|All participants who received at least 1 dose of study treatment.||participants|||Number
13524|NCT01939548|Secondary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec.|Screening/Baseline up to Week 12 (or Early Termination)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified ECG parameter.||participants|||Number
13525|NCT01939548|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate of <40 or more than (>)120 beats per minute (bpm); and standing pulse rate of <40 or >140 bpm.|Screening up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified vital sign parameter.||participants|||Number
13526|NCT01939548|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.||participants|||Number
13527|NCT01939548|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12|CGI-I: 7-point clinician-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Participants in the FAS who were evaluable for this outcome measure at Week 12.||units on a scale||Standard Deviation|Mean
13528|NCT01939548|Secondary|Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician-rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. n=number of evaluable participants in the FAS at the specified time point.||units on a scale||Standard Deviation|Mean
13529|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores|The subscales based on Marder factors are: negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 7 to 49 for negative symptoms, 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for uncontrolled hostility/excitement and anxiety/depression. Higher scores indicate higher severity of symptoms.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.||units on a scale||Standard Deviation|Mean
13530|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales|The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.||units on a scale||Standard Deviation|Mean
13543|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
16179|NCT01866709|Secondary|Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS.||First 48 hours|Study was prematurely terminated for safety reasons; no statistical analyses were conducted.|||||
13531|NCT01939548|Secondary|Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score|The Personal and Social Performance Scale (PSP) is a validated clinician-related scale that measured personal and social functioning in the domains of: socially useful activities (eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviors. Information from the participant and the informant were utilized in determining the rating. A PSP total score was determined from the 4 domains (score range 0-100). A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a participant with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. The number of evaluable participants at Week 12 were those in the FAS with available data at Week 12 (n=number of evaluable participants at the specified time point)||units on a scale||Standard Deviation|Mean
13532|NCT01939548|Primary|Change From Baseline to Week 12 in PANSS Total Score|The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Week 12|All participants in the Full Analysis Set (FAS, defined as all participants who received at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline measurement) who had available data for this outcome measure at Week 12.||units on a scale||Standard Deviation|Mean
13533|NCT01939548|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline|The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|All participants who received study treatment.||units on a scale||Standard Deviation|Mean
13534|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6|The difference in seated heart rate and standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||beats per minute||Standard Deviation|Mean
13535|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6|The difference in seated office blood pressure and standing office blood pressure was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13536|NCT01939496|Secondary|Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||beats per minute||Standard Deviation|Mean
13537|NCT01939496|Secondary|Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The seated heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||beats per minute||Standard Deviation|Mean
13538|NCT01939496|Secondary|Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13539|NCT01939496|Secondary|Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13540|NCT01939496|Secondary|Change From Baseline in Body Weight to Week 6|Body weight was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||Kilogram (kg)||Standard Deviation|Mean
13541|NCT01939496|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6|The fasting plasma glucose was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimoles per liter (mmol/L)||Standard Deviation|Mean
13542|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13544|NCT01939496|Secondary|Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13545|NCT01939496|Secondary|Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13546|NCT01939496|Secondary|Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13547|NCT01939496|Secondary|Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Day 2|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13548|NCT01939496|Primary|Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using last observation carried forward (LOCF) method.||millimeter of mercury (mmHg)||Standard Deviation|Mean
13549|NCT01939314|Secondary|Headache Free at 24 Hours|The percentage of patients that were headache free at 24 hours by follow-up phone conversation.|24 hours|||percentage of participants|||Number
13550|NCT01939314|Secondary|Categorical Pain Relief|"Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as No, Little, Some, A Lot or Complete. The table displays the number of participants who identified their pain relief in the categories provided."|15 minutes from dose|||participants|||Number
13551|NCT01939314|Primary|Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale||15 minutes from dose|||percentage of participants|||Number
13552|NCT01939145|Other Pre-specified|Bacterial Culture Results|Compare the qualitative bacterial culture results between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||||
13553|NCT01939145|Other Pre-specified|Wound Recidivism|Compare the percent of wounds that remained closed 30 days and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|30 days post discharge from hospital||||||
13554|NCT01939145|Other Pre-specified|Time to Closure|Compare the percent of wounds closed and the time to closure during the hospital admission and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||||
13555|NCT01939145|Secondary|Hospital Admission Length of Stay|Compare the hospital admission length of stay between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||days||Standard Deviation|Mean
13556|NCT01939145|Primary|Number of Operating Room Visits|Compare the number of operative room visits between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||Operative Room Visits||Standard Deviation|Mean
13557|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing|The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.||participants|||Number
13558|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing|The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.||participants|||Number
13559|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Antibody Screening|The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.||participants|||Number
14750|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks|||joints||Inter-Quartile Range|Median
13560|NCT01939002|Secondary|Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period|Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.|Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and had FLS; n=number of participants assessed at the given timepoint.||hours||Standard Deviation|Mean
13561|NCT01939002|Secondary|Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.|Day 1 to Week 52|Safety population: all participants who received at least 1 injection of study treatment.||participants|||Number
13562|NCT01939002|Secondary|Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population|Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.|Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13563|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.||days||Standard Deviation|Mean
13564|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.||days||Standard Deviation|Mean
13565|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.||days||Standard Deviation|Mean
13566|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13567|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13608|NCT01938430|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.||percentage of participants|||Number
39494|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|12 week follow up||||||
13568|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13569|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13570|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13571|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13572|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13573|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13574|NCT01939002|Secondary|Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS||during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.||percentage of participants|||Number
13575|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13576|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13577|NCT01939002|Secondary|Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13578|NCT01939002|Secondary|Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.||units on a scale||Standard Deviation|Mean
13579|NCT01939002|Secondary|Summary of Average Duration of FLS in the 48 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.||hours||Full Range|Median
13580|NCT01939002|Secondary|Summary of Average Duration of FLS in the First 8 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.||hours||Full Range|Median
13581|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||units on a scale||Standard Deviation|Mean
13582|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||units on a scale||Standard Deviation|Mean
13583|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
13584|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
13585|NCT01939002|Secondary|Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.|4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
13586|NCT01939002|Secondary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
13629|NCT01938040|Primary|Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP)|Serum concentration of cortisol, CRP, drawn in Post Anesthesia Care unit at 2 hours following surgery were compared with those same levels drawn preoperatively and intraoperatively.|2 hours following end of surgery|||pg/mL||Standard Deviation|Mean
13587|NCT01939002|Primary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population|The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.||percentage of participants|||Number
13588|NCT01938989|Primary|Photostress Recovery Time|Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.|Day 1|This analysis population includes all participants with observation minus any major protocol deviations.||seconds||Standard Deviation|Mean
13589|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
13590|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.||percentage of participants|||Number
13591|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
13592|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
13593|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
13594|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
13595|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
13596|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
13597|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||percentage of participants|||Number
13598|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||percentage of participants|||Number
13599|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.||percentage of participants|||Number
13600|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
13601|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
13602|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
13603|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
13604|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
13605|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set||percentage of participants|||Number
13606|NCT01938430|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttransplant Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.||percentage of participants|||Number
13607|NCT01938430|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.||percentage of participants|||Number
13609|NCT01938430|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.||percentage of participants|||Number
13610|NCT01938430|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.||percentage of participants|||Number
13611|NCT01938430|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.||percentage of participants|||Number
13612|NCT01938430|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
13613|NCT01938430|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.||percentage of participants|||Number
13614|NCT01938170|Secondary|Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home|This study will also assess the feasibility of having parents/caregivers administer Flumist vaccine outside a traditional medical environment and without the direct participation of medical personnel. We will ask parents by telephone survey at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home, about maintaining temperature and conditions proper for vaccine storage until administration. We will also ask about ease of vaccine disposal and about child preferences for receiving vaccine at home compared to at a dedicated medical visit.|0-12 days|||participants|||Number
13615|NCT01938170|Primary|Number of Subjects That Reported Successful Home Vaccination With no Adverse Events|We will assess the tolerability of giving the FluMist nasal vaccine at home by parents/caregivers to their children by performing telephone survey follow up. We will ask parents at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home and any adverse events encountered when giving FluMist at home.|0-12 days|||participants|||Number
13616|NCT01938079|Primary|Cumulative Fentanyl Equivalents From ECMO Initiation to Decision to Achieve Wakefulness|Culmulative fentanyl equivalents meaning the combination of sedative drug regimen - measured in mg - from ECMO initiation to decision to achieve wakefulness.|Up to 14 days|||mg||Inter-Quartile Range|Median
13617|NCT01938066|Secondary|Amount of Pain Medication Used (Morphine)|will measure the amount of pain medication used (morphine)|5 days|||mg||Standard Deviation|Mean
13618|NCT01938066|Primary|Wound Infection|At the end of 5 days all subjects will get a Culture and Sensitivity to see if they have an infection or what type of infection they have in the wound|At the end of 5 days|||participants|||Number
13619|NCT01938040|Secondary|Geriatric Depression Scale|15 questions. Score 1 point for each answer selected which indicates depression. Score of 0-5 is normal. A score >5 suggests depression.|Preoperatively, post operative day 1 and post op day3|||units on a scale||Standard Deviation|Mean
13620|NCT01938040|Secondary|Cognitive Recovery.|Digits span forward subject is asked to repeat a series of numbers with increasing number of digits forward. Digit span backward subject is asked to repeat a series of numbers backward with increasing number of digits. Correct response is worth 1 point. Maximum of 14 points for each sub score with a total of 28 points for total score|preoperatively- 2 hours in PACU, Post op day #1, post op day#3|||units on a scale||Standard Deviation|Mean
13621|NCT01938040|Other Pre-specified|Cytokine Concentrations|IFN y, IL-1B IL-2 were below the limit of detection and no assessments could be made. The lower limit for all cytokine detection was 3.2pg/mL|preoperative-intraoperative-postopoperative||||||
13622|NCT01938040|Secondary|Immune Response:Serum Concentration of IL-10,|.drawn in PACU 2 hours following arrival and compared to preoperative and intraoperative values|2 hours post arrival in PACU|||pg/mL||Full Range|Mean
13623|NCT01938040|Secondary|Modified Fatigue Severity Scale|This questionnaire contains 9 statements that rate severity of fatigue symptoms. Score 1 indicates strong disagreement with the statement and 7= strong agreement. i.e (I am easily fatigued).Total lowest possible score indicating no fatigue is 9. Total highest possible score is 63 which correlates to severe fatigue, interfering with all activities of daily living.|preoperative-postoperative day 1 and day 3|||scores on a scale||Standard Deviation|Mean
13624|NCT01938040|Secondary|Quality of Recovery-40|Quality of Recovery-40 has been used to assess postoperative recovery from anesthesia where higher score correlate with improved recovery and well being. The survey has 5 domains: comfort scale ranges 1-60 with higher value indicating greater comfort, emotions scale ranges 1-45 with higher value indicating best emotional state, physical independence scale ranges 1-25 with higher value indicating best independence, patient support scale ranges 1-35 with a higher score indicating greater support and pain scale 1-35 with higher number indicating greater relief from pain. Scoring is done for PART A on a scale of 1-5 (1=very poor=none of the time, worst score, 5=excellent=all of the time, best possible score).PART B on a scale of 1-5 (1=very poor or all the time worse score), 5=excellent or none of the time, best score) Perfect score=200.|preoperatively and -postoperative days 1 and 3|||units on a scale||Standard Deviation|Mean
13625|NCT01938040|Secondary|Immune Response IL-6||2 hours postoperatively in PACU|||pg/mL||Full Range|Mean
13626|NCT01938040|Post-Hoc|IL-6||preoperatively-intraoperatively-postoperatively|||pg/mL||Full Range|Mean
13627|NCT01938040|Post-Hoc|Immune Response: TNF Alpha||preoperatively-intraoperatively-postoperatively|||pg/mL||Full Range|Mean
13628|NCT01938040|Post-Hoc|Sympathetic Response: Epinephrine and Norepinephrine Plasma Concentrations||intraoperatively|||pg/mL||Standard Deviation|Mean
39495|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|5 weeks (or after treatment session 10)||||||
13630|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Liters||95% Confidence Interval|Geometric Mean
13631|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Liters/hr||95% Confidence Interval|Geometric Mean
13632|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Hours||Geometric Coefficient of Variation|Geometric Mean
13633|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Hours||Full Range|Median
13634|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM||95% Confidence Interval|Geometric Mean
13635|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
13636|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||95% Confidence Interval|Geometric Mean
13637|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Liters||95% Confidence Interval|Geometric Mean
13638|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Liters/hr||95% Confidence Interval|Geometric Mean
13639|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.||Hours||Geometric Coefficient of Variation|Geometric Mean
13640|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||Hours||Full Range|Median
13641|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM||95% Confidence Interval|Geometric Mean
15916|NCT01875159|Primary|Number of Seconds of Intermittent Hypoxia Per Hour|Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat||seconds per hour||Standard Deviation|Mean
13642|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
13643|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||95% Confidence Interval|Geometric Mean
13644|NCT01937871|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2|The modified IPSS is the total IPSS collected at 2 weeks post-baseline.The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.|Baseline, Week 2|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline mIPSS measurement.||units on a scale||Standard Error|Least Squares Mean
13645|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
13646|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score is determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
13647|NCT01937871|Secondary|Change From Baseline in IIEF EF at Week 4 and Week 8|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
13648|NCT01937871|Secondary|Change From Baseline in Total IPSS at Week 4 and Week 8|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
16566|NCT01854593|Secondary|Vascular Endothelial Growth Factor Concentration in Vitreous|Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.|Start of surgery.|||μg/ml||Standard Deviation|Mean
13649|NCT01937871|Secondary|Change From Baseline in IIEF Subscores at Week 12|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
13650|NCT01937871|Secondary|Change From Baseline in IIEF Sexual Desire at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
13651|NCT01937871|Secondary|Change From Baseline in IIEF Orgasmic Function at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
13652|NCT01937871|Secondary|Change From Baseline in IIEF Intercourse Satisfaction at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
13653|NCT01937871|Secondary|Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
13654|NCT01937871|Secondary|Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12|CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline CGI-I measurement.||Participants|||Count of Participants
13655|NCT01937871|Secondary|Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PGI-I measurement.||Participants|||Count of Participants
13671|NCT01937715|Secondary|Number of Participants With Gene and/or Protein Expression Biomarkers Relating to the PI3K and/or mTOR Pathway Activation in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.|||||
13656|NCT01937871|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12|"IPSS QoL assess participant response to the following question:If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline QoL measurement.||units on a scale||Standard Error|Least Squares Mean
13657|NCT01937871|Secondary|Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12|IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
13658|NCT01937871|Secondary|Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12|IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
13659|NCT01937871|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at Week 12|The amount of urine remaining in the bladder after void completion.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PVR measurement.||milliliters (mL)||Standard Deviation|Mean
13660|NCT01937871|Secondary|Change From Baseline in Uroflowmetry Measures at Week 12|"Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter).~At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline Uroflowmetry measurement.||Milliliters/seconds (mL/sec)||Standard Deviation|Mean
13661|NCT01937871|Secondary|Change From Baseline in IPSS at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
13662|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?.The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
13934|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13663|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of “yes” responses at endpoint minus the percentage of “yes” responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||"percentage of yes responses"||Standard Error|Least Squares Mean
13664|NCT01937871|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12|IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who had at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.||units on a scale||Standard Error|Least Squares Mean
13665|NCT01937871|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
13666|NCT01937715|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C) (Phase 2)|The FACT-C was to assess health-related quality of life and colorectal cancer (CRC)-related symptoms. It includes a total of 36 items, which are summarized into 6 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), CRC subscale (9 items) which addresses a subset of CRC concerns such as diarrhea.|Day 1 of each cycle|FACT-C was only applicable to the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.|||||
13667|NCT01937715|Secondary|Number of Participants With Evidence of Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue (Phase 2)|Biomarker evaluation were to be performed on these fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Levels of signaling proteins in biopsied tumor tissue was the secondary endpoint for the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.|||||
13668|NCT01937715|Secondary|Overall Survival (Phase 2)|Overall survival is the time from randomization date to date of death due to any cause.|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.|||||
13669|NCT01937715|Secondary|Duration of Response (Phase 2)|Duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death.|Day 1 to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.|||||
13670|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 2)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.|||||
13935|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13672|NCT01937715|Secondary|Number of Participants With Expression of Gene Sequences or Gene Amplications in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.|||||
13673|NCT01937715|Secondary|Number of Participants Meeting Maximum Post-Baseline QTc Interval Values|Criteria for corrected QT interval using Fridericia's formula (QTcF) meeting potential clinical concern included: an absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; an absolute change 30 - <60, >=60 msec.|Baseline, Cycle 1 Day 1, and Cycle 2 Day 2|All participants who received at least 1 dose of study medication.||participants|||Number
13674|NCT01937715|Secondary|Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan|Terminal Elimination Half-Life of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||hour||Standard Deviation|Mean
13675|NCT01937715|Secondary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf): PF-05212384 and Irinotecan|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
13676|NCT01937715|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-05212384 and Irinotecan|Area Under the Curve From Time Zero to Last Quantifiable Concentration of PF-05212384, and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
13677|NCT01937715|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): PF-05212384, Irinotecan, and Fluorouracil|Time to Reach Maximum Observed Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||hour (hr)||Full Range|Median
13678|NCT01937715|Secondary|Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil|Maximum Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
13679|NCT01937715|Secondary|Number of Participants With Urinalysis Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Urinalysis test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication.||participants|||Number
13680|NCT01937715|Secondary|Number of Participants With Chemistry Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Chemistry test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.||participants|||Number
13681|NCT01937715|Secondary|Number of Participants With Coagulation Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Coagulation test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.||participants|||Number
13682|NCT01937715|Secondary|Number of Participants With Hematological Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 hematological test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication.||participants|||Number
13683|NCT01937715|Secondary|Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AE grades were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.||participants|||Number
13684|NCT01937715|Secondary|Number of Participants With All Causality AEs by System Organ Class (SOC)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.||participants|||Number
13685|NCT01937715|Secondary|Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the event occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment; or the event was seen prior to the start of treatment but increased in CTCAE version 4.0 grade after the start of study treatment and within 28 days after final dose of study treatment.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.||participants|||Number
13704|NCT01937520|Secondary|Glucose|the first two blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|serum glucose from baseline to PACU arrival|females||mg/dL||Standard Error|Mean
13705|NCT01937520|Primary|Pain Levels|Visual Acuity scale 0=no pain 10= worst pain possible|PACU, day 1 , day 2, day 3|female patients self reported pain experience following surgery||units on a scale||Standard Error|Mean
13686|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 1B)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose|All participants in the full analysis (FA) set who had measureable disease and an adequate baseline assessment of the disease.||participants|||Number
13687|NCT01937715|Primary|Progression-Free Survival (PFS)|Progression-free survival was the time from randomization the date to date of first documentation of progression or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)|PFS was the primary efficacy endpoint for the study and was only to be assessed in the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2.|||||
13688|NCT01937715|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy|DLTs were classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and defined as any of the following events judged to be attributed to the combination of PF-05212384 plus FOLFIRI: hematologic (febrile neutropenia or a sustained temperature >=38 degrees Celcius for >1 hour, grade >=3 neutropenic infection, grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia); non-hematologic (grade >=2 pneumonitis, grade >=3 toxicities, toxicities which resulted in failure to deliver at least 75% of the planned total dose of PF-05212384 and/or 50% of the planned total dose of FOLFIRI during the first cycle, toxicities which resulted in delay of start of Cycle 2 by >2 weeks of scheduled day (Day 43 of study), Grade 3 QTc prolongation).|Day 1 up to Day 28|The dose limiting toxicity analysis set included participants in Phase 1B who started treatment and who did not have a major treatment deviation in the lead-in period and the first cycle of treatment.||percentage of participants|||Number
13689|NCT01937598|Secondary|AUC Active GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
13690|NCT01937598|Secondary|AUC Active GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
13691|NCT01937598|Secondary|AUC Total GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
13692|NCT01937598|Secondary|AUC Total GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
13693|NCT01937598|Secondary|AUC Glucagon||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||pmol/l*min||Standard Error|Mean
13694|NCT01937598|Secondary|AUC C-peptide||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||nmol/l*min||Standard Error|Mean
13695|NCT01937598|Secondary|AUC Insulin||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||nmol/l*min||Standard Error|Mean
13696|NCT01937598|Secondary|AUC Plasma Glucose|Incremental AUC from 0 to 300 min|Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)|||mmol/l*min||Standard Error|Mean
13697|NCT01937598|Primary|Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)|Incremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test.|0 to 300 min post mixed meal test|||[mg*min/dL]||Standard Error|Mean
13698|NCT01937520|Secondary|Serum Insulin Level|to determine if electroacupuncture reduced hyperglycemia|preoperative and postoperative|female subjects preoperatively and postoperatively||pg/ml||Standard Error|Mean
13699|NCT01937520|Secondary|TGFB1|TGFB1 is a pleiotropic factor regulating the immune system and healing. First two blood samples drawn under general anesthesia, first prior to surgical incision and EA, the 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|all females; then females by groups age (<45 years and >45 years) and weight (<75kg and >75kg)||pg/ml||Standard Error|Mean
13700|NCT01937520|Secondary|IL-10|IL-10 is an anti-inflammatory cytokine marker. First two blood samples were collected during general anesthesia, first prior to surgical incision and EA, 2nd 60 minutes following incision and EA, and the third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|total females; then those grouped by age (<45years and>45 years) and weight (<75 Kg and >75kg)||pg/ml||Standard Error|Mean
13701|NCT01937520|Secondary|IL-6|First two blood samples were collected during general anesthesia, first prior to Surgical incision and EA, 2nd 60 minutes after incision and EA and the 3rd after arrival in PACU but before administration of analgesia. IL-6 is a critical inflammatory cytokine produced during the acute phase of reaction to trauma|Preoperatively-intraoperatively-postoperatively|total female results; then females divided into age groups (<45 or >45years) and weights groups (<75kg and >75kg)||pg/ml||Standard Error|Mean
13702|NCT01937520|Secondary|iNTERLEUKIN (IL-2 and IL-4)|both are IL-2 and IL-4 are critical cytokines regulating the cellular response to induce cellular versus hormone immunity. First two blood samples were collected during general anesthesia: first prior to surgical incision and electroacupuncture, second 60 minutes after incision and electroacupuncture and the 3rd after arrival in PACU but before analgesia.|Preoperatively-intraoperatively-postoperatively|all females||pg/ml||Standard Error|Mean
13703|NCT01937520|Secondary|Tumor Necrosis Factor (TNF)|First two blood samples were collected during general anesthesia, first prior to surgical incision and Electro-acupuncture (EA), 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia. TNF is a critical pyrogen produced during acute phase of a reaction to trauma.|preoperatively-intraoperatively-postoperatively|female subjects||pg/ml||Standard Error|Mean
13706|NCT01937520|Primary|Morphine Equivalent|equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.|PACU, day 1 , day 2, day 3|since gender impacts the threshold for analgesic and pain the effects of electroacupuncture on females was analyzed. The same number of females were in both groups but since one subject had preexisting levels of TNF>1ug/ml prior to surgery she was eliminated from the dta base||mg morphine||Standard Error|Mean
13707|NCT01937520|Secondary|Cortisol|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|prior to surgical incision, 1 hour following incision, after arrival in PACU|females||ng/ml||Standard Error|Mean
13708|NCT01937520|Secondary|Modified Quality of Recovery Scale|Modified patient self reported scale with 9 questions regarding general well being including ability to eat, free from constant pain, able to manage activities of daily living. 0= worst possible score and 18=best outcome score|Day 1, 2, 3|all females||units on a scale||Standard Error|Mean
13709|NCT01937520|Secondary|Morphine Equivalent (mg)|morphine equivalent to analyze whether body weight affected the efficacy of electroacupuncture|PACU arrival to 2 hours post op|females with body weight <75 kg and >than 75 kg||mg morphine||Standard Error|Mean
13710|NCT01937520|Secondary|Morphine Equivalent|All analgesic treatments were converted to morphine equivalents in milligrams .|PACU to 2 hours post op|females grouped by age (<45 years and 45 years or greater)||mg of Morphine||Standard Error|Mean
13711|NCT01937520|Secondary|(ACTH )Adrenocorticotropic Hormone|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia. The data below represents female patients only|serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACU|females||pg/ml||Standard Error|Mean
13712|NCT01937520|Primary|Visual Acuity Score (VAS)|VAS is a self reported pain scale with a score ranging from 0 to 10. 0= no pain, 10=worst pain possible. Multiple pain sacores were recorded. single value is reported by average|arrival in PACU to 2 hours post operatively|all study participants||units on a scale||Standard Error|Mean
13713|NCT01937520|Primary|Reduced Pain Medication Requirement|analgesia provided in Post Anesthesia Care Unit PACU)|amount of pain medication provided in PACU|All subjects enrolled in study||mg of Morphine||Standard Error|Mean
13714|NCT01937312|Secondary|Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
13715|NCT01937312|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||percent change||Standard Deviation|Mean
13716|NCT01937312|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
13717|NCT01937312|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
13718|NCT01937299|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.||percent change||Standard Deviation|Mean
16567|NCT01854593|Primary|Reoperation|Vitreoretinal reoperation due to recurrent vitreous hemorrhage.|1 month|||participants|||Number
13719|NCT01937299|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
13720|NCT01937299|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.||mmHg||Standard Deviation|Mean
13721|NCT01937130|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"||RLU||Inter-Quartile Range|Median
13722|NCT01937130|Secondary|Levels of CK18/M65|Caspase full-length cytokeratin serum levels CK18/M65|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"||U/L||Inter-Quartile Range|Median
13723|NCT01937130|Secondary|Levels of CK18/M30|Caspase-cleaved cytokeratin serum levels (CK18/M30)|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"||U/L||Inter-Quartile Range|Median
13724|NCT01937130|Primary|Tmax & t1/2 Parameters|Primary endpoints for tmax & t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days|"t1/2 number of participants analyzed at Day 1 in the 5mg arm was 2 and 1 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values."||(h)|Participants|Standard Deviation|Mean
13725|NCT01937130|Primary|Cmax|Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days|||(ng/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
13726|NCT01937130|Primary|Area Under the Curve (AUC)|Primary endpoints for AUC_0-8, AUC_0 last, AUC_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.|28 days|"AUC_0-last: The number of participants analyzed in the 25mg arm was 7 at Day 1 AUC_0-inf: The number of participants analyzed in the 5mg arm was 2 at Day 1 and 0 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values."||h*ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
13727|NCT01936181|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 30, Week 54, Week 78||||||
13728|NCT01936181|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 30, Week 54, Week 78||||||
13729|NCT01936181|Secondary|ACR20||Week 54, Week 78|||percentage of participants|||Number
13730|NCT01936181|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 30|||percentage of participants|||Number
13731|NCT01936896|Other Pre-specified|Safety|We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.|3 months||||||
13732|NCT01936896|Secondary|Left Ventricular End-systolic Volume Change|We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography|3 months|Only 5 patients had paired (i.e. baseline and 3 months) echocardiograms for evaluation||mL||Inter-Quartile Range|Median
13733|NCT01936896|Primary|C Reactive Protein (Area Under the Curve)|A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.|14 days|||mg/L||Inter-Quartile Range|Median
13734|NCT01936844|Secondary|Brachial Artery Vasoreactivity|Change in flow mediated vasodilatation (FMD) of the brachial artery. Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. The change is FMD is reported as the % change in FMD from baseline to 14 days.|14 days|Some patients did not undergo assessment at 14 days because they did not show up to their scheduled appointment.||percentage change||Inter-Quartile Range|Median
13735|NCT01936844|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction (LVEF) between admission and 14 day follow up. This value is expressed as absolute change in measured LVEF. For example, if baseline LVEF = 20% and 14 day LVEF = 25%, this would be reported as an absolute change of 5%.|14 days|Some patients did not undergo LVEF assessment at 14 days because they did not show up to their scheduled appointment.||percent LVEF||Inter-Quartile Range|Median
13736|NCT01936844|Primary|C Reactive Protein|"The proportional area-under-the-curve for plasma C reactive protein (CRP) levels measured during the first 3 days of admission. The proportion (y-axis) is calculated at each time-point with respect to the baseline CRP. The resultant y-axis is a unitless proportion. The x-axis is listed as days"|3 days|1 patient in each group withdrew from the study prior to collection of data for the primary endpoint.||days||Inter-Quartile Range|Median
13738|NCT01936662|Primary|Endoscopist Satisfaction|"Endoscopist was surveyed to determine their satisfaction with each of the airway devices.~Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:~The airway device did not interfere at all with the ability to perform the scope.~The airway device presented some interference with the scope, but not enough to cause difficulty.~The airway device made it difficult to perform the endoscopy.~The airway device prevented the endoscopy from being performed."|2 hours|||units on a scale||Standard Deviation|Median
13739|NCT01936649|Secondary|To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection)|Measurements of H/M ratio and the extent of difference between H/M measurements following AdreView administration and 15 minutes delayed planar imaging on 2 separate days within an interval of 5 to 14 days, was used to assess the test-retest reproducibility. Data from test-retest study was used to estimate the normal ranges for variation in quantitation of myocardial tracer uptake using AdreView. H/M ratios were calculated by 3 technologists and average of 3 technologists was calculated based on non-missing technologists reviewing results. All non-missing technologist evaluations were averaged per participant.|15 minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView; had at least an interpretable planar image acquisition at 15 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.||Ratio||Standard Deviation|Mean
13740|NCT01936649|Primary|To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection)|Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability.|3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView (Iobenguane I 123 Injection); had at least an interpretable planar image acquisition at 3 hours 50 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.||Ratio||Standard Deviation|Mean
13741|NCT01936389|Primary|Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)|Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.|6 months|||mmHg||Standard Deviation|Mean
13742|NCT01935622|Primary|Peak Aerobic Exercise Capacity|Interval change in peak VO2 measured at cardiopulmonary test|14 days|||||Inter-Quartile Range|Median
13743|NCT01934790|Other Pre-specified|SSE-free Survival|The SSE-FS is the time (days) from the treatment start date to the first SSE on or following the start date or death, whichever occurred first. Participants not experiencing death or an SSE at the database cutoff date for primary completion were censored at the last assessment for SSEs.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13744|NCT01934790|Other Pre-specified|Time to First Symptomatic Skeletal Event (SSE)|Time to first symptomatic skeletal event (SSE) is the time (days) from the treatment start date to the first SSE on or following the start date. Participantsnot experiencing an SSE at the database cutoff date for primary completion, whether or not surviving, were censored at the last assessment for SSEs.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13745|NCT01934790|Other Pre-specified|Time to Pain Progression|Pain progression was defined in participants evaluable for pain progression at baseline, i.e., participants with a WPS of ≤ 7 at the baseline assessment. Pain assessment occurred daily for 1 week, beginning 1 week prior to each visit and including the day of the visit. An evaluable pain assessment interval required completion of a minimum of 4 out of 7 daily questions. Pain progression was defined as the occurrence of either a pain increase or an increase in pain management with respect to baseline, whichever occurred first.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13746|NCT01934790|Other Pre-specified|Percentage of Participants With Pain Improvement|Pain improvement was defined in evaluable participants (participants with worst pain score [WPS] of 4 at baseline) as a 30% and 2-point decrease in WPS over 2 consecutive measurements conducted at least 4 weeks apart, without an increase in pain management. Pain improvement rate was the number of participants with pain improvement, divided by the total number of evaluable participants WPS was the mean of the WPS in the last 24 hours from the preceding 7 days.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
13747|NCT01934790|Other Pre-specified|Overall Survival|Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13748|NCT01934790|Other Pre-specified|Time to PSA Progression|Prostate specific antigen progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value, and an increase in absolute value of ≥ 2 ng/mL above nadir. The time to PSA progression was defined as the time (days) from the treatment start date to the date of first PSA progression. Participants without PSA progression as of the database cutoff for primary completion, whether or not surviving, were censored at the last PSA laboratory assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13763|NCT01934582|Secondary|To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose.|The 6-minute walk test (6MWT) was conducted at PK Visits 1 and 2, and was performed between hours 3 to 6 post-morning dose to correlate with the predicted peak plasma concentration of oral treprostinil.|The 6MWT was conducted during BID dosing PK collection (up to 14 days prior to transitioning to TID dosing regimen [PK Visit 1]) and during TID dosing PK collection (up to 35 days after transitioning to TID dosing regimen [PK Visit 2]).|||Meters||Full Range|Mean
13749|NCT01934790|Other Pre-specified|Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as a ≥ 30% reduction of blood PSA level compared with the baseline value, confirmed by a second subsequent PSA value with a ≥ 30% reduction from baseline approximately 4 or more weeks later. Prostate specific antigen response rate was defined as the number of participants with PSA response divided by the total number of participants evaluable for PSA response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
13750|NCT01934790|Other Pre-specified|Percent Change in Total ALP||Baseline and Week 12, Week 24|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
13751|NCT01934790|Other Pre-specified|Time to Total ALP Progression|Total ALP progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value to at least 1.5 x ULN (upper limit of normal). The time to total ALP progression was defined as the time (days) from the treatment start date to the date of first total ALP progression. Participants not experiencing ALP progression at the database cutoff date, whether or not surviving, were censored at the last ALP laboratory assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13752|NCT01934790|Other Pre-specified|Percentage of Participants With Total Alkaline Phosphatase (ALP) Response|Total alkaline phosphatase (ALP) response was defined as ≥ 30% reduction of the blood total ALP level compared with the baseline values. Total ALP response rate was defined as the number of participants with total ALP response divided by the total number of participants evaluable for total ALP response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
13753|NCT01934790|Other Pre-specified|Time to Radiological Bone Progression|Time to radiological bone progression was defined as the time (days) from the treatment start date to the date of radiological bone progression (according to the adapted PCWG2 [Prostate Cancer Clinical Trials Working Group 2] criteria), as documented by the investigator. Participants not experiencing radiological bone progression at the database cutoff for primary completion were censored at the last radiological bone progression assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13754|NCT01934790|Other Pre-specified|Radiological Progression Free Survival (rPFS)|Radiological progression-free survival (rPFS) was defined as the time from the treatment start date to the date of radiological disease progression or death from any cause (if death occurred before such progression), as documented by the investigator. Participants not experiencing death or radiological disease progression at the database cutoff for primary completion were censored at the last radiological disease progression assessment.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
13755|NCT01934790|Primary|Number of Participants Who Discontinued Radium-223 Dichloride Treatment Due to Treatment Emergent AEs or Death|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
13756|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Biochemistry Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
13757|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Hematology Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
13758|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related SAEs in the Active Follow-up Period|Treatment-related SAE is any SAE that, according to the investigator’s causality assessment, is possibly or probably related to treatment with radium-223 dichloride.|Up to 2 years after last treatment||09/2017||||
13759|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related AEs in the Active Follow-up Period|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study.|Up to 2 years after last treatment||09/2017||||
13760|NCT01934790|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|TESAE occurred after the start of radium-223 dichloride treatment until 30 days after the last dose and results in death; is life-threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly / birth defect; is another medically important serious event as judged by the investigator; or is an occurrence of leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis, and primary bone cancer or any other new primary malignancy, such as acute myeloid leukemia.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
13761|NCT01934790|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.||Participants|||Number
13762|NCT01934582|Secondary|To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing.|AE diaries including 8 therapy-specific terms were collected during both BID and TID dosing to allow for comparison of events from both regimens. The therapy-specific events included: diarrhea, extremity pain, flushing, headache, hypotension, jaw pain, nausea, and vomiting.|The AEs were recorded for up to 50 days.|||percentage of subjects|||Number
13764|NCT01934582|Primary|To Assess the Pharmacokinetics (AUClast) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)|||h*ng/mL||Full Range|Mean
13765|NCT01934582|Primary|To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)|||ng/mL||Full Range|Mean
13766|NCT01934582|Primary|To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)|||mg||Full Range|Mean
13767|NCT01934517|Primary|Overjet|Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor|one year|||mm||95% Confidence Interval|Mean
13768|NCT01934504|Secondary|Immunosuppression Associated Signature|"Definition of an immune signature associated with maintenance immunosuppression.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to 8 Weeks Post-Immunosuppression Withdrawal|No analyses were performed due to slow enrollment and early study closure.|||||
13769|NCT01934504|Secondary|Tolerance Signature Versus Clinical Status|"Correlation of possible changes in the tolerance signature with changes in clinical status.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.|||||
13770|NCT01934504|Secondary|Tolerance Signature Stability|"Measurement of the stability of a tolerance immune signature in patients with AAV over time.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.|||||
13771|NCT01934504|Primary|Tolerance Biomarker Identification|"Identification of biomarkers associated with clinical tolerance in patients with ANCA-associated vasculitis by comparative immunophenotyping of individual leukocyte subsets from tolerant and non-tolerant patients with AAV.~Due to early study termination, data was not available to evaluate this endpoint."|Difference from baseline to week 26|No analyses were performed due to slow enrollment and early study closure.|||||
13772|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)|The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each par. using the following classification: Bact. eradication (erad.), presumed bact. erad. and colonization were categorized as erad. Bact. persistence (pers.), presumed bact. pers. and superinfection were categorized as pers. Bact. erad. elimination of the pathogen (path.) after trt; presumed bact. erad.-resolution of signs/symptoms (s/s) after trt; colonization-resolution of s/s but initial path. still recovered from sample; bact. pers.-no improvement in s/s and initial path. was recovered from sample; presumed bact. pers.-no improvement in s/s and isolation of initial path. was impossible/not performed; superinfection-initial path. was eradicated but a new path. was recovered; unable to determine-bact. test could not be performed.|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1||Participants|||Number
13773|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8|"The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each path. If the same pathogen was not detected at the EOT, this pathogen was classified as eradication (E). If the same pathogen was detected at the EOT, this pathogen was classified as persistence (P)."|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1||Participants|||Number
13774|NCT01934231|Secondary|Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15|The investigator (or sub-investigator) categorized the severity of symptoms such as rhinorrhoea and bad mood/productive cough as none, mild/small amount (M/SA), or moderate or severe (M or S). For the nasal cavity finding of nasal/postnasal discharge (N/PD) the categozation was serous [containing serum]), mucopurulent (MU/SA [containing both mucus and pus]), and moderate or larger amount (M/LA). In cases in which both sides of the nasal cavity were affected and there was no difference in severity between the sides, the right-side results were recorded. If there was a difference in severity, the more severe-side results were recorded.|Baseline (BL), Day 4, Day 8, and Day 15|PP Population||Participants|||Number
13807|NCT01933776|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
13775|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) and TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation. In order to be categorized as cure, participants had to meet the criteria for cure at both Day 8 and Day 15."|Day 8 and Day 15|PP Population||Participants|||Number
13776|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT: Day 8)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 8|PP Population||Participants|||Number
13777|NCT01934231|Primary|"Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC: Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 15|Per Protocol (PP) Population: all participants randomized to treatment who received the study drug for at least the first 3 days of study treatment in the Treatment Period and had evaluable data on both Day 8 and Day 15 with treatment compliance between 80% and 100% and no major protocol deviations||Participants|||Number
13778|NCT01933880|Secondary|Number of Participants Compliant With Treatment|Number of Participants who are Compliant with Treatment will be accessed. Less than 80 percent and more than 120 percent compliance signifies bad compliance, 80 to 120 percent compliance signifies good compliance . The compliance was calculated by the percentage of dose (actual dose multiplied by 100/theoretical dose).The theoretical dose means the dose prescribed by the Investigator.|End of Week 12|"FAS population for OROS-MPH Group. Here N signifies participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||participants|||Number
13779|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12|Remission rate in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale.|Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."||Percentage of participants|||Number
13780|NCT01933880|Secondary|Change From Baseline in Completion Time of Stroop Color-word Test at Week 12|Completion time of stroop color-word test in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test will be scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median time of the naming time in the Stroop color word naming test will be accessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at each time point for each specific arm."||Seconds||Standard Deviation|Mean
13781|NCT01933880|Secondary|Change From Baseline in Total Scores of Digit Span Test at Week 12|The digit span test total score will be accessed in different dosage groups to evaluate the relationship between therapeutic effect and dosage. The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is16, and the maximum subscore in the Digits Backward is 14, for a total score of 30. A higher score was indicative of better recall and attention.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."||Scores on a scale||Standard Deviation|Mean
13811|NCT01933672|Secondary|Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14|Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
16568|NCT01854593|Secondary|Postoperative Vitreous Hemorrhage.|Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.|1 month|||participants|||Number
13782|NCT01933880|Secondary|Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12|IOWA conners behavior rating scale score in different dosage groups will be accessed to evaluate relationship between therapeutic effect and dosage. IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."||Scores on a scale||Standard Deviation|Mean
13783|NCT01933880|Secondary|Number of Participants With Clinical Global Impression - CGI Scale Score|CGI is an overall rating scale. Clinical Global Impression (Improvement of Diseases) is divided into seven grades: 1=very significant improvement, 24=significant improvement or advanced, 3=improvement or slightly advanced, 4=no change, 5=slight aggravation, 6=significant aggravation, and 7=very significant aggravation or seriously aggravated. Number of participants in each category of grade were assessed.|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test||Participants|||Number
13784|NCT01933880|Secondary|Academic Achievement|Mathematics and language scores will be obtained from their corresponding examinations at school. Scores ranges from 0-100 respectively. Mathematics and language would be summarized separately.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||scores on a scale||Standard Deviation|Mean
13785|NCT01933880|Secondary|Coding Test|The coding Test is a common test indicator for perceptual speed. The test presents a series of corresponding relationship between graphics and symbols to the participant, and then participants will be required to fill out the appropriate symbol following single symbol in the test part. The test is limited within 150 seconds and evaluated the number of symbols been replaced correctly by the participants.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Number of symbols correctly replaced||Standard Deviation|Mean
13786|NCT01933880|Secondary|WCST: Learning to Learn (L-C)|"WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. Learning to learn indicator was a measure of decrement in the number of responses needed to achieve each successive category. The raw score ranged from 0 to 100. The high, negative value suggests the participants could not effectively learn the task presented by the WCST. Only calculated in those completed 3 or more categories and not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case)."|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of responses||Standard Deviation|Mean
13787|NCT01933880|Secondary|WCST: Failure to Maintain Set (Fm)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The frequency (number of times) of responses completed with 5 to 9 continuous correct was evaluated. Ranges from 0 to 26 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of times||Standard Deviation|Mean
13788|NCT01933880|Secondary|WCST: Non-Persistent Error Responses (nRpe)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Non perseverative error responses are the errors remaining after subtracting persistent errors from total errors. Ranges from 0 to 128 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of non-persistent error responses||Standard Deviation|Mean
13824|NCT01933425|Secondary|Surgical Conditions During Suturing of the Abdominal Fascia|Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)|1 hour|Evaluation of surgical conditions was compared using Mann–Whitney U-test.||participants|||Number
13789|NCT01933880|Secondary|WCST: Percentage of Perseverative Error Responses (Rpe%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative (pvt) errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of persistent errors out of total number of responses was evaluated. Ranges from 0 to 100%, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Percentage of pvt error responses||Standard Deviation|Mean
13790|NCT01933880|Secondary|WCST: Perseverative Error Responses (Rpe)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Perseverative error responses are the number of responses which applied continuity principle for matching answers and also had the wrong answer was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of perseverative error responses||Standard Deviation|Mean
13791|NCT01933880|Secondary|WCST: Perseverative Responses (Rp)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of perseverative responses were the responses which applied continuity principle for matching answers was evaluated. Ranges from 0 to 100, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of perseverative responses||Standard Deviation|Mean
13792|NCT01933880|Secondary|WCST: Percentage of Conceptual Level Responses (Rf%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of the responses completed with 3-10 continuous correct during the entire measuring process was evaluated. Ranges from 0 to 100%, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||percentage of conceptual level responses||Standard Deviation|Mean
13793|NCT01933880|Secondary|WCST: First Response (Rf)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of responses needed to complete the first color classification was evaluated. Ranges from 9 to 128, the lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of first responses||Standard Deviation|Mean
13808|NCT01933776|Primary|Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
13936|NCT01930487|Secondary|Change in Ocular Perfusion Pressure|change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)|baseline and 30 days|patients completing both study periods||mm Hg||Standard Error|Mean
13794|NCT01933880|Secondary|WCST: Percentage of Correct Responses (Rc%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0 to 100 percent (%), the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Percentage of correct responses||Standard Deviation|Mean
13795|NCT01933880|Secondary|WCST: Error Responses (Re)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of error responses which did not comply with the response principles was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of error responses||Standard Deviation|Mean
13796|NCT01933880|Secondary|WCST: Correct Responses (Rc)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The number of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0-116, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||number of correct responses||Standard Deviation|Mean
13797|NCT01933880|Secondary|WCST: Completed Categories (Cc)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. In completed categoriies, number of categories completed out of 6 sorting categories after the test was evaluated. Ranges from 0 to 6. The more the number of categories completed the better is the response.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Nunber of Categories Completed||Standard Deviation|Mean
13798|NCT01933880|Secondary|Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. During number of trials administered or administered responses, participants were administered 128 cards and asked to sort the cards until all the 6 sorting categories was completed. Response number used to complete all 6 categories ranges from 50 to 128, lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."||Responses||Standard Deviation|Mean
13809|NCT01933672|Secondary|Plasma PF-04937319 Time for Cmax (Tmax) on Day 14|Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||hour||Full Range|Median
13810|NCT01933672|Secondary|Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14|Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
13799|NCT01933880|Secondary|Stroop Color Word Naming Test|This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test is scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median naming time in the Stroop color word naming test will be assessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|FAS for OROS-MPH Group included participants who took at least 1 study drug therapy and had at least 1 efficacy evaluation. FAS for normal group included participants who had baseline assessment scale evaluation and had at least 1 endpoint assessment scale evaluation. ‘n’=participants who were evaluable at each specific time point for each arm.||Seconds||Standard Deviation|Mean
13800|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.|Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test.||Percentage of Participants|||Number
13801|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 12|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
13802|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 7|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
13803|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 3|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
13804|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 2|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
13805|NCT01933880|Primary|Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 1|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."||Scores on a scale||Standard Deviation|Mean
13806|NCT01933880|Primary|Change From Baseline in Digit Span Test Total Score at Week 12|The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention.|Baseline and Week 12|Full Analysis Set (FAS) population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. FAS for normal group included all participants who received baseline assessment scale evaluation and had at least one endpoint assessment scale evaluation.||Scores on a scale||Standard Deviation|Mean
13812|NCT01933672|Secondary|Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14|Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
13813|NCT01933672|Secondary|Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||mL/min||Geometric Coefficient of Variation|Geometric Mean
13814|NCT01933672|Secondary|Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Two (2) PK parameters specified in the protocol and SAP were not reported: AUClast was not reported since it was the same as AUC24 in this study, and apparent volume of distribution (Vz/F) was not reported since the log-linear terminal phase of the concentration-time profiles was not consistently well characterized in the 24-hour sampling period.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
13815|NCT01933672|Secondary|Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||participants|||Number
13816|NCT01933672|Secondary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: sitting systolic BP (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing SBP less than (<) 90 mm Hg; sitting diastolic BP (DBP) >=20 mm Hg change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing DBP <50 mm Hg; 2), pulse rate (supine): <40 or greater than (>) 120 beats per minute (bpm).|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||participants|||Number
13817|NCT01933672|Secondary|Change From Baseline in Body Weight (kg)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||kg||Standard Error|Mean
13818|NCT01933672|Secondary|Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.||participants|||Number
13819|NCT01933672|Secondary|Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment. HAEs meeting protocol definition were summarized descriptively by treatment.||participants|||Number
13820|NCT01933672|Secondary|Change From Baseline in Pre-meal Insulin on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for insulin at 0, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.||micro international unit/milliliter||Standard Error|Least Squares Mean
13821|NCT01933672|Secondary|Change From Baseline in Pre-meal C-Peptide on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for C-peptide at the pre-specified nominal timepoints at predose, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.||nanograms/milliliter (ng/mL)||Standard Error|Least Squares Mean
13822|NCT01933672|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections at the pre-specified nominal timepoints of each period: predose (ie, time “0”), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours on Day 0 (baseline) and Day 14; and predose on Days 1 and 15.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.||mg/dL||Standard Error|Least Squares Mean
13823|NCT01933672|Primary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14|Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.|Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement at both baseline and on Day 14.||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
13827|NCT01933399|Secondary|Change Score in the Patient Specific Activity Scale|Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.|Baseline and 2-weeks|||units on a scale||95% Confidence Interval|Mean
13828|NCT01933399|Primary|Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)|Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.|Baseline and 2 weeks|||units on a scale||95% Confidence Interval|Mean
13829|NCT01933334|Secondary|University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores|UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant’s assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health.|Baseline, Weeks 4, 8, 12, and 16|Safety population. n = number of participants analyzed at specified time.||units on a scale||Standard Deviation|Mean
13830|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.||percentage of participants|||Number
13831|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.||percentage of participants|||Number
13832|NCT01933230|Primary|To Determine if Neck Cooling Affects Brain Temperature.||During the 2 hours of neck cooling||||||
13833|NCT01933230|Primary|To Determine if Neck Cooling Affects Intracranial Pressure||During 2 hours of neck cooling||12/2015||||
13834|NCT01933230|Primary|To Determine if Temperature Can be Reduced by 1 Degree Per Hour in the ICU Setting.|We will monitor body temperature|During the 2 hours of neck cooling|||degrees celsius||Standard Deviation|Mean
13835|NCT01932762|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|24 weeks after end of all therapy (Study Week 36)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
13836|NCT01932762|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|4 weeks after end of all therapy (Study Week 16)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
13837|NCT01932762|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
13838|NCT01932762|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
13839|NCT01932762|Secondary|Mean Time to First Achievement of Undetectable HCV RNA During Treatment|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).|From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)|FAS; all randomized participants who received ≥1 dose of study therapy. Participants in the FAS not achieving TND were censored from the analysis.||days||Standard Error|Mean
13840|NCT01932762|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related.|Treatment period plus the first 14 days of follow-up (up to 14 weeks)|All-Subjects-As-Treated (ASAT) Population; all randomized participants who received ≥ 1 dose of study therapy. The percentage of participants with specific AEs and accompanying 95% CI were reported for each treatment arm.||percentage of participants||95% Confidence Interval|Number
13841|NCT01932762|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)|SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.|12 weeks after end of all therapy (Study Week 24)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations) with available data.||percentage of participants||95% Confidence Interval|Number
13842|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration|||ml||Standard Deviation|Mean
13843|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration|||L/min||Standard Deviation|Mean
13844|NCT01932606|Secondary|Change in Arteriovenous Oxygen Difference After Study Drug (Exercise)|Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration|||ml/dl||Standard Deviation|Mean
13845|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||ml/min||Standard Deviation|Mean
13846|NCT01932606|Secondary|Change in LVSW After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration|||g/beat||Standard Deviation|Mean
13847|NCT01932606|Secondary|Change in SVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration|||dyne/s * cm^5||Standard Deviation|Mean
13848|NCT01932606|Secondary|Change in PA Compliance After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration|||ml/mm Hg||Standard Deviation|Mean
13849|NCT01932606|Secondary|Change in PVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration|||mm Hg/L/min||Standard Deviation|Mean
13850|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
13851|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||beats/minute||Standard Deviation|Mean
13852|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
39496|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|2.5 weeks (or after treatment session 5)||||||
13853|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration|||ml||Standard Deviation|Mean
13854|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) The volume of blood pumped per minute by each ventricle of the heart. Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration|||L/min||Standard Deviation|Mean
13855|NCT01932606|Secondary|Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration|||ml/dl||Standard Deviation|Mean
13856|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||ml/min||Standard Deviation|Mean
13857|NCT01932606|Secondary|Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration|||g/beat||Standard Deviation|Mean
13858|NCT01932606|Secondary|Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration|||dyne/s * cm^5||Standard Deviation|Mean
13859|NCT01932606|Secondary|Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration|||ml/mm Hg||Standard Deviation|Mean
13860|NCT01932606|Secondary|Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration|||mm Hg/L/min||Standard Deviation|Mean
13861|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
13862|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||beats/minute||Standard Deviation|Mean
13863|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
13864|NCT01932606|Primary|Exercise Pulmonary Capillary Wedge Pressure (PCWP)|Pulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.|during repeat exercise run, approximately 30 minutes after study drug administration|||mm Hg||Standard Deviation|Mean
13865|NCT01932164|Primary|Quality of Bone Regeneration|The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.|Three months after the graft||03/2015||||
13866|NCT01932164|Primary|Amount of New Bone Mass Formed|The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.|6 months from surgical procedure for alveolar grafting;|3 females and 2 males with cleft lip and palate||percentage of bone formation||95% Confidence Interval|Mean
13867|NCT01932112|Secondary|Atrial Fibrillation Recurrence|At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation)|between 0 and 12 months||||||
13868|NCT01932112|Primary|Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion|After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.|5 minutes after IV adenosine|||participants|||Number
13869|NCT01932060|Secondary|Hemoglobin Indices After Cesarean Delivery|Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery|24 hr after cesarean delivery|||g/dl||Inter-Quartile Range|Median
13870|NCT01932060|Primary|Total Estimated Blood Loss|Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).|immediately at end of surgery|||ml||Inter-Quartile Range|Median
13871|NCT01931878|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment."|6 weeks|||participants|||Number
13872|NCT01931878|Other Pre-specified|Patients With Pain on Visual Analog Scale <4|The Visual Analog Scale (VAS) consists of a line which represents the level of pain in 10 cms. The subject is required to make this line to show where your pain level is on this line (for example, at the 7cm mark). A higher score is associated with a higher level of pain. Number of patients showing a pain score of <4.|6 weeks|||participants|||Number
13873|NCT01931878|Primary|Mean Total Restless Leg Syndrome Rating Scale Score|The Restless Legs Syndrome Rating Scale uses 10 questions, each scored 0-4, with higher scores representing more severe symptoms. Score ranges from 1-40. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40)|6 weeks|Total RLS scale score was compared between incoA injections and and saline group injections.||units on a scale||Standard Deviation|Mean
13874|NCT01931865|Other Pre-specified|Patients Improved in Patient Global Impression of Change (PGIC) Scale|The Patient Global Impression of Change questionaire asks patient level of satisfaction with current treatment (from very unsatisfactory to very satisfactory).|12 weeks|Advanced cancer patients||participants|||Number
13875|NCT01931865|Secondary|Patients Who Show Improvement in American Pain Association Questionnaire|This quality of life scale consists of 10 questions regarding how pain affects your quality of life.|12 weeks|Advanced cancer patients||participants|||Number
13876|NCT01931865|Primary|Number of Participants With a Significant Reduction in Pain|visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale.|12 weeks|||participants|||Number
13877|NCT01931527|Secondary|Determine the Effect of Reducing Uric Acid on Oxidative Status|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). Systemic (urinary isoprostanes) and skeletal muscle (carbonylated protein ratio) oxidative stress and total antioxidant capacity (plasma and saliva TRAP and FRAP) will be measured in obese subjects with high uric acid before and after uric acid reduction.|12 hours after reducing uric acid|||ng/mg||Standard Error|Mean
13878|NCT01931527|Primary|Determine the Effect of Reducing Uric Acid on Insulin Sensitivity|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure skeletal muscle insulin sensitivity in obese subjects with high uric acid before and after uric acid reduction.|12 hours after reducing uric acid|||% incr. in insulin-mediated gluc. uptake||Standard Error|Mean
13879|NCT01931475|Secondary|Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). Response to treatment is defined by endpoint PGI rating of either “much better” or “very much better”.The last observation carried forward (LOCF) method will be used for these analyses.|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||percentage of participants|||Number
13880|NCT01931475|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.The last observation carried forward (LOCF) method will be used for these analyses.|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||percentage of participants|||Number
13881|NCT01931475|Secondary|Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)|Evaluation on whether the change in BPI average pain intensity scores is a direct analgesic effect of duloxetine and is independent of treatment effect on mood, as measured by Hospital Anxiety and Depression Scale (HADS) depression subscale (HADS-D), or anxiety as measured by HADS anxiety subscale (HADS-A). Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Deviation|Mean
13882|NCT01931475|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores|HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale [0 (low level of anxiety or depression) to 3 (high level of anxiety or depression)], giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Mean was calculated using analysis of covariance (ANCOVA) and adjusted for treatment, pooled investigator, and baseline score. The last observation carried forward (LOCF) method will be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Mean
13908|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13883|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Interference|BPI Interference Average Score is a self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people,sleep, and enjoyment of life.The average Interference scores ranged from 0 to 10. General activity, mood,walking ability, normal work,relations with other people, sleep and enjoyment of life is each is a self-reported scale that measures the interference of pain in the past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.The Interference scores ranged from 0 (does not interfere) to 10 (completely interferes).Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
13884|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Severity|BPI Severity of Worst Pain is self-reported scale that measures the severity of pain based on the worst pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Right Now Pain is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
13885|NCT01931475|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline,13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
13886|NCT01931475|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores|WOMAC consists of 24 items divided into 3 subscales:Pain(5 items):during walking,using stairs,in bed,sitting or lying,and standing Stiffness;(2 items):after first waking and later in the day Physical Function;(17 items):stair use,rising from sitting, standing, bending,walking,getting in/out of a car,shopping,putting on/taking off socks,rising from bed,lying in bed,getting in/out of bath,sitting,getting on/off toilet,heavy household duties,light household duties.Each question is answered using a 5-point Likert scale(0 to 4).Pain subscale has a range of scores of 0(none) to 20(extreme).Stiffness subscale has a range of scores of 0(none) to 8(extreme).Physical function subscale has a range of scores of 0(none) to 68(extreme).Total score ranges from 0(none) to 96(extreme).Least squares(LS) mean was calculated using analysis of covariance(ANCOVA) and adjusted for treatment, pooled investigator,and baseline score.Last observation carried forward (LOCF) method was be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
13887|NCT01931475|Secondary|Patient Global Impressions of Improvement (PGI-I) Score|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
13888|NCT01931475|Primary|Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
13889|NCT01931150|Primary|Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions|Change from Baseline in the Number of Lesions at 28 days|28 days|||participants|||Number
13890|NCT01930890|Primary|Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).||participants|||Number
13909|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
15280|NCT01894607|Secondary|Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)|Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.|1 day|1 participant was ineligible.||participants|||Number
13891|NCT01930890|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).||participants|||Number
13892|NCT01930799|Secondary|Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire|The Patient Post-Video Questionnaire was based on 5 individual questions assessing the patient’s perception of the utility of the video in helping them 1) understand how MS can affect the bladder, 2) how to recognize bladder symptoms, 3) understand various treatment options, 4) understand self-help strategies, and 5) better manage their bladder problems. Percentages represent the proportion of patients who “agree/completely agree” with each question. Patients viewed the video at the Baseline visit, then completed the Patient Post-Video Questionnaire immediately after viewing the video at the Baseline visit.|Baseline|Eligible enrolled subjects||Percentage of Patients|||Number
13893|NCT01930799|Primary|Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores|The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.|Baseline, Month 6|Eligible and enrolled subjects who completed the Month 6 visit||Scores on a Scale||Standard Deviation|Mean
13894|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
13895|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
13896|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
13897|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
13898|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - No DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||mm Hg||Standard Error|Mean
13899|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||mm Hg||Standard Error|Mean
13900|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13901|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13902|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13903|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13904|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13905|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13906|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
16569|NCT01854593|Secondary|Intra Operative Hemorrhage|Calculate the number of coagulators for the intra operative hemorrhage.|End of the surgery.|||coagulators||Standard Deviation|Mean
13910|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13911|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13912|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13913|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13914|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13915|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13916|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13917|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13918|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13919|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13920|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13921|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13922|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13923|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13924|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13925|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13926|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13927|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||ratio||Standard Error|Mean
13928|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13929|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods||cm/s||Standard Error|Mean
13937|NCT01930487|Primary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
13938|NCT01930487|Primary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods||% zero pixels||Standard Error|Mean
13939|NCT01930435|Secondary|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period|during 12 weeks duration|||participants|||Number
13940|NCT01930435|Secondary|Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification|Feeding Tube Placement in Patients Who Use Personalized Sterile Humidification, as determined by placement of either nasogastric or gastrostomy tube. This was enumerated as the number of participants who had a feeding tube placed.|over 12 weeks duration|||participants|||Number
13941|NCT01930435|Secondary|Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks|The maximum severity of clinician rating of mucositis observed over 12 weeks, as graded on a scale ranging from 1 (minimal mucositis) to 3 (confluent mucositis) to 5 (death) using the Common Terminology Criteria for Adverse Events v 4.0|over 12 weeks duration|||units on a scale||Standard Deviation|Mean
13942|NCT01930435|Secondary|Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.|Compliance was pre-specified in the protocol as self-reported usage of the device at a level equal to or greater than 60% of the formal recommended usage. This cut-off at 60% represented the median of the distribution of the usage of the device among all patients. The outcome measure is the percentage of participants who reported using the device at a level equal to or greater than 60% of the total prescribed usage.|over entire 12 weeks duration|||percentage of participants|||Number
13943|NCT01930435|Primary|Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.|The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0–10 NRS, with 0 being “not present” and 10 being “as bad as you can imagine.” There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food, mouth/throat sores, and problems with teeth or gums. Scores for the subscales (general, interference, HN) are averaged so that a score is obtained from 0-10 for each subscale. The mean change in quality of life is calculated as the average scores at 6 weeks minus the average of the scores at baseline. Therefore a positive value represents a worsened quality of life and a negative value is an improvement in quality of life.|Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]|||units on a scale||95% Confidence Interval|Mean
13944|NCT01929031|Secondary|Time to Meaningful Pain Relief|Time to meaningful pain relief was captured by a stopwatch, which was started by the study staff immediately after the administration of the first dose of trial medication and which was to be stopped by the patient as soon as he/she felt meaningful pain relief. Time to meaningful pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||hours||95% Confidence Interval|Median
13945|NCT01929031|Secondary|Duration of Pain Relief|Duration of pain relief was defined as the time between the administration of first dose of trial medication and first dose of rescue medication or second dose of trial medication, whichever was first. Duration of pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||hours||95% Confidence Interval|Median
13946|NCT01929031|Secondary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h)|SPRID0-2h: Time-weighted sum of PAR and PID from 0 to 2 hours, score range: -10 (worst) to 28 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5 and 2 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 2 was considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 2 hours.|0 to 2 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||units on a scale||Standard Error|Least Squares Mean
13947|NCT01929031|Primary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h)|SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 8 were considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 8 hours.|0 to 8 hours|Randomized patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)||units on a scale||Standard Error|Least Squares Mean
13987|NCT01930058|Secondary|Trough Plasma Concentration (C24hr) of MK-8876|C24hr is a measure of the plasma drug concentration 24 hours post-dose (i.e., trough concentration). Plasma C24hr was determined on Day 1 and Day 7 of MK-8876 dosing.|24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||nM||Geometric Coefficient of Variation|Geometric Mean
16674|NCT01852162|Secondary|Clot Kinetic: Clot Stength|Clot strength (maximal amplitude:MA) was assessed by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography||mm||Standard Deviation|Mean
13948|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or MUGA) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= LLN, >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population||Participants|||Number
13949|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Electrocardiogram Findings at the Indicated Time Points|Single 12-lead ECGs were performed at Baseline, Weeks 3, 12, 24, 36, 48 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - CS, or abnormal - NCS, as determined by the investigator.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
13950|NCT01928940|Secondary|Phase II: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3, 8, 12, 16, 20, 24, 28, 32, 36, 40 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Kg||Standard Deviation|Mean
13951|NCT01928940|Secondary|Phase II: Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation, or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8 and15; Weeks 3, 8, 12, 16, 20, 24, 28, 32, 36, 40; post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Percentage of oxygen in blood||Standard Deviation|Mean
13952|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees C, change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population||Participants|||Number
13953|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 bpm, change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 0.6 years)|ATS Population||Participants|||Number
13954|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|SBP and DBP values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 mmHg), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 0.6 years)|ATS Population||Participants|||Number
13955|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in ECOG Perormance Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50% of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population||Participants|||Number
13956|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Urinalysis Results|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for UOB, UGLU, UKET, UM and UUBIL were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population||Participants|||Number
13988|NCT01930058|Secondary|Maximum Plasma Concentration (Cmax) of MK-8876|Cmax is a measure of the maximum plasma concentration of drug post-dose. Plasma Cmax was determined on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||nM||Geometric Coefficient of Variation|Geometric Mean
13957|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, WBC counts, basophils, eosinophils, hematocrit, MCHC, MCH, MCV, monocytes and RBC count.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population||Participants|||Number
13958|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Clinical Chemistry Parameters|CCPs were graded according to NCI CTCAE garde version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline grade occurred. CCPs that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, ALT, AST, total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, LDH, total protein, urea/BUN and uric acid.|From Baseline until the post-treatment Visit (average of 0.60 years)|ATS Population||Participants|||Number
13959|NCT01928940|Secondary|Phase II: Number of Participants With Any Adverse Event and Any Serious Adverse Event|An AE is defined as any untoward MO in a part. temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xULN and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 0.60 years)|ATS Population||Participants|||Number
13960|NCT01928940|Secondary|Phase II: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 0.60 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
13961|NCT01928940|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 0.60 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
13962|NCT01928940|Secondary|Phase II: Number of Participants With Unconfirmed Overall Response|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 0.60 years)|ATS Population||Participants|||Number
13963|NCT01928940|Secondary|Phase I: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 0.75 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
13989|NCT01930058|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hr post-dose. Plasma AUC0-24hr was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||µM*hr||Geometric Coefficient of Variation|Geometric Mean
13964|NCT01928940|Secondary|Phase I: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 0.75 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.||Weeks||Full Range|Median
13965|NCT01928940|Secondary|Phase I: Number of Participants With Unconfirmed Overall Response Rate|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 0.75 years)|ATS Population||Participants|||Number
13966|NCT01928940|Secondary|Phase I: Number of Participants With Confirmed Overall Response Rate|"Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR according to RECIST, version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 0.75 years)|ATS Population||Participants|||Number
13967|NCT01928940|Secondary|Phase I: Time of Occurrence of Cmax (Tmax) and Terminal Phase Half Life (t1/2) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Tmax is defined as the time of occurrence of Cmax. Tmax was determined directly from the raw concentration-time data. The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/lamdaz, where lamdaz is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data. . T1/2 was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)||hr||Full Range|Median
13968|NCT01928940|Secondary|Phase I: Plasma Trough Concentration (Ctau) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Trough concentration is the lowest level that a drug is present in the body. Pre-dose (trough) blood samples were collected on Day 8, Day 15, Weeks 3, 8, 16 and 24 for estimating plasma trough concentration. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Ctau was determined from the raw concentration-time data.|At pre-dose on Day 8, Day 15, Weeks 3, 8, 16 and 24|PK Population.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
13969|NCT01928940|Secondary|Phase I: Maximum Plasma Concentration (Cmax) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683 and GSK2167542. Cmax was determined from the raw concentration-time data.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
13970|NCT01928940|Secondary|Phase I: Area Under the Plasma Concentration Versus Time Curve (AUC) of GSK2118436 and Metabolites, and GSK1120212 After Single and Repeat Dose|Blood samples were collected from each par. at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. AUC from time zero to last quantifiable concentration (concn) (AUC[0-t]) was determined using the linear trapezoidal rule for increasing concn and the logarithmic trapezoidal rule for decreasing. The AUC from time zero extrapolated to infinity (AUC[0-inf] was calculated, where data permit, as the sum of AUC(0-t) and Ct/z, where Ct is the observed plasma concn obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant. Area under the concentration-time curve over 12 hr and 24 hr dosing interval is called AUC[0-12] and AUC[0-24]. AUC(0-inf) was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population: all par. included in the ATS population for whom a PK sample was obtained and analyzed. Only those par. available at the specified time points were analyzed (represented by n=X in the category titles).||hr*nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
13990|NCT01930058|Primary|Mean Change From Baseline in HCV Viral Load|The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.|Baseline and Day 7|All participants in Panels A, B, and E are included in the analysis.||Log10 change||Standard Error|Mean
13971|NCT01928940|Primary|Phase II: Number of Participant With Confirmed Overall Response|"Confirmed overall response (ORR) is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and blinded independent central review (BICR)."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 0.60 years)|ATS Population||Participants|||Number
13972|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram (ECHO)|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= lower limit of normal (LLN), >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 0.75 years)|ATS Population||Participants|||Number
13973|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Electrocardiogram (ECG) Findings at the Indicated Time Points|Single twelve (12)-lead ECGs were perfomred at Baseline, Weeks 3, 12, 24, 36, 48 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
13974|NCT01928940|Primary|Phase I: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from Baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit ( average of 0.75 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Kilogram (Kg)||Standard Deviation|Mean
13975|NCT01928940|Primary|Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen,that is called as blood oxygen saturation or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8 and 15; Weeks 3, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Percentage of oxygen in blood||Standard Deviation|Mean
13976|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 0.75 years)|ATS Population||Participants|||Number
13977|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population||Participants|||Number
13978|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 millimeters of mercury [mmHg]), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population||Participants|||Number
13991|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.||nM||95% Confidence Interval|Geometric Mean
14106|NCT01928472|Primary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.|Day 43|FAS-Day 43||Ratio||95% Confidence Interval|Geometric Mean
13979|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50 percent (%) of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population||Participants|||Number
13980|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Urinalysis Parameters|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for urine occult blood (UOB), urine glucose (UGLU), urine ketones (UKET), urine protein (UM) and urine urobilinogen (UUBIL) were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population||Participants|||Number
13981|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) counts, basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes and red blood cell (RBC) count.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population||Participants|||Number
13982|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs)|CCPs were graded according to NCI CTCAE grade version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters (para) for which an increase to G3 or G4 from BL G occurred. CCPs that were not G according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those para for which the category decreased to Low or increased to High relative to the BL category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid.|From Baseline until the post-treatment Visit (average of 0.75 year)|ATS Population||Participants|||Number
13983|NCT01928940|Primary|Phase I: Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as an event occurred during the first 21 days after the first dose of study drugs and met any of the following criteria, according to National Cancer Institutes (NCI) common terminology criteria for AE (CTCAE) grade (G) version 4.0: G4 hematological toxicity; G3 or G4 non-hematologic toxicity (including rash, nausea, vomiting and diarrhea only if uncontrolled with supportive therapy); rash >=G3 that required dose reduction despite supportive care; a G2 or greater non-hematological toxicity that in the judgment of the investigator and medical monitor; dose interruption of greater than 14 consecutive days due to unresolved toxicity; any new G2 or greater valvular heart disease and significant alteration in cardiac valve morphology from Baseline.|From the start of study treatment until 21 days|DLT assessment Population: all participants for whom DLT assessment was appropriately conducted||Participants|||Number
13984|NCT01928940|Primary|Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence (MO) in a part. temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xupper limit of normal(ULN) and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 0.75 year)|All Treated Subject (ATS) Population: all participants who received at least one dose of study medication.||Participants|||Number
13985|NCT01930058|Secondary|Apparent Terminal Plasma Half-life (t½) of MK-8876|t½ is the time required for the maximum plasma drug concentration to reduce by 50% post-dose. Plasma t½ was determined on Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Day 7|All participants in Panels A, B, and E are included in the analysis.||Hours||Geometric Coefficient of Variation|Geometric Mean
13986|NCT01930058|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8876|Tmax is a measure of time required to reach the maximum plasma drug concentration post-dose. Plasma Tmax was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.||Hours||Full Range|Median
41441|NCT01438229|Primary|Office Systolic Blood Pressure Change||Baseline to 6 months|Subjects with both baseline and 6M follow up office blood pressure measurements||mmHg||Standard Deviation|Mean
13992|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.||hr.nM||95% Confidence Interval|Geometric Mean
13993|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.||nM||95% Confidence Interval|Geometric Mean
13994|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.||nM||95% Confidence Interval|Geometric Mean
13995|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.||hr.nM||95% Confidence Interval|Geometric Mean
13996|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.||nM||95% Confidence Interval|Geometric Mean
13997|NCT01929993|Primary|The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.|Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.|one month after the procedure|Any compromised margin.||participants|||Number
13998|NCT01929980|Primary|Number of Participants With Response|"For Autoimmune Hemolytic Anemia- At least 3 of 5 criteria should be met.~Stabilization of hemoglobin without transfusions by 2 weeks~Conversion of DAT from + to - by 6 weeks~Normalization of serum haptoglobin levels by 6 weeks~Normalization of indirect bilirubin levels by 6 weeks~Reduction in the frequency of transfusions by 50% by 4 weeks~For Autoimmune Neutropenia- At least 2 of 3 criteria should be met.~Stabilization of absolute neutrophil count by 2 weeks~Undetectable antineutrophil antibodies by 6 weeks~Reduction in GCSF dose by 50% by 6 weeks~For Autoimmune Thrombocytopenia- At least 2 of 3 criteria should be met.~Stabilization of platelet count without platelet transfusions by 2 weeks~Undetectable antiplatelet antibodies by 6 weeks~Reduction in the frequency of platelet transfusions by 50% from pre-bortezomib values by 6 weeks"|6 weeks|||participants|||Number
13999|NCT01929889|Primary|Change in Social Cognition at 12 Weeks|"Facial Affect Perception Test that assesses the ability to accurately recognize facially expressed emotions as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 30 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome.~Cognitive Empathy Test that assesses the ability to accurately determine the emotional expression of another person as depicted in a static image of a social interaction as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 60 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome."|baseline and twelve weeks|||units on a scale||Standard Deviation|Mean
14000|NCT01929876|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Itraconazole and Hydroxy-Itraconazole|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0-24) of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post cobimetinib dose on Day 4|PK population||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
14001|NCT01929876|Secondary|Tmax of Itraconazole and Hydroxy-Itraconazole|Time to reach maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||hours||Full Range|Median
14002|NCT01929876|Secondary|Cmax of Itraconazole and Hydroxy-Itraconazole|Maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
14022|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 2 weeks after procedure|||participants|||Number
14187|NCT01925170|Secondary|Biopsy Rate|Biopsy rate = number of participants who had a biopsy/number of number of participants analyzed.|12 months after mammography and MBI|||percentage of participants||95% Confidence Interval|Number
16549|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)||Through 7 to 8 months post vaccination||||||
14003|NCT01929876|Secondary|Apparent Volume of Distribution (Vz/F) of Cobimetinib With and Without Itraconazole|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||liter (L)||Geometric Coefficient of Variation|Geometric Mean
14004|NCT01929876|Secondary|Apparent Clearance (CL/F) of Cobimetinib With and Without Itraconazole|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
14005|NCT01929876|Secondary|Plasma Half-Life (t1/2) of Cobimetinib With and Without Itraconazole|Plasma half-life is the time measured for the plasma concentration to decrease by one half.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||hours||Full Range|Median
14006|NCT01929876|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Cobimetinib With and Without Itraconazole|AUC (0-t) = Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t) of cobimetinib with and without itraconazole was assessed. It was calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
14007|NCT01929876|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Cobimetinib With and Without Itraconazole|Time to reach maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population||hours||Full Range|Median
14008|NCT01929876|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of Cobimetinib With and Without Itraconazole|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) of cobimetinib with and without itraconazole, assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
14009|NCT01929876|Primary|Maximum Observed Plasma Concentration (Cmax) of Cobimetinib With and Without Itraconazole|Maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of cobimetinib and had evaluable PK data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
14010|NCT01929473|Secondary|Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization|Questionnaire|365 day||||||
14011|NCT01929473|Secondary|Antibodies of Varicella, Mumps and Rubella|Questionnaire|0 day||||||
14012|NCT01929473|Secondary|Incidence of Pertussis|Questionnaire|0 day||||||
14013|NCT01929473|Primary|IgG|Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).|0 day, 365 day (2 points)|||EU/mL(log transformed)||Standard Deviation|Mean
14014|NCT01929460|Secondary|Median Cyst Fluid Amylase|Median cyst fluid amylase for classification of mucinous cystic lesions|six weeks|||Units/L||Inter-Quartile Range|Median
14015|NCT01929460|Secondary|Median Cyst Fluid Carcinoembryonic Antigen (CEA)|Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks|||ng/mL||Inter-Quartile Range|Median
14016|NCT01929460|Secondary|Mean Cyst Fluid Amylase|Mean cyst fluid amylase for classification of mucinous cystic lesions|six weeks|||Units/L||Full Range|Mean
14017|NCT01929460|Secondary|Mean Cyst Fluid Carcinoembryonic Antigen (CEA)|Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks|||ng/mL||Full Range|Mean
14018|NCT01929460|Secondary|Procedure-related Complications|Number of patients with procedure-related complications|six weeks after procedure|||participants|||Number
14019|NCT01929460|Secondary|Adverse Drug Reactions|Number of participants with adverse drug reactions|six weeks|||participants|||Number
14020|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 6 weeks after procedure|||participants|||Number
14021|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 4 weeks after procedure|||participants|||Number
14023|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their “on ” periods and asleep in diary cards every day. Percentage of awake time spent “On” without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias [“On” time minus “On” time with troublesome dyskinesias] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “On” without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent “On” without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||percentage of awake time spent on||Standard Deviation|Mean
14024|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “on ” periods and asleep in diary cards every day. Percentage of awake time spent on is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent on) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent on). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||percentage of awake time spent on||Standard Deviation|Mean
14025|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “on ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On” without troublesome dyskinesias (actual hours) is calculated as [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at visit minus [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||hours||Standard Deviation|Mean
14026|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On”(actual hours) is calculated as awake time spent “On” (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent “On” (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||hours||Standard Deviation|Mean
14027|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Percentage of awake time spent “off” is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “off”) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent “off”). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||percentage of awake time spent off||Standard Deviation|Mean
14190|NCT01925170|Secondary|Specificity|Specificity measures the percentage of negatives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified negative cancer status at 12 months after the initial screening (mammography and MBI).||percentage of true negatives||95% Confidence Interval|Number
14028|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent “off”) from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent “off”). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||hours||Standard Deviation|Mean
14029|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Participants|||Number
14030|NCT01929317|Secondary|Number of Participants Remaining in the Study||From the start of the study medication (Week 0) until Week 52|Safety Population 2 (SP2) compraised of all participants who included in SP1 (receive at least one dose of medication in Dose Increase Effect Verification Phase) and shifted to Long-term Phase and received at least one dose of medication in Long-term Phase.||Participants|||Number
14031|NCT01929317|Secondary|Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12|The CGI global improvement scale allows the investigator to rate the participant’s total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Week 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
14032|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On” without troublesome dyskinesias (actual hours) is calculated as [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at visit minus [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||hours||Standard Deviation|Mean
14033|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On”(actual hours) is calculated as awake time spent “On” (hours) at the indicated visit minus awake time spent “On” (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||hours||Standard Deviation|Mean
14034|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Percentage of awake time spent “off” is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “off”) from the post Baseline value (percentage of awake time spent “off”). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||percentage of awake time spent off||Standard Deviation|Mean
14035|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “Off”(actual hours) is calculated as awake time spent “Off” (hours) at the indicated visit minus awake time spent “Off” (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||hours||Standard Deviation|Mean
14036|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
14037|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
14038|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
14039|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Percent change||Standard Deviation|Mean
14040|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
16550|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains)||Through 7 to 8 months post vaccination||||||
14041|NCT01929317|Secondary|Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
14042|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
14043|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.||Scores on a scale||Standard Deviation|Mean
14044|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
14045|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Percent change||Standard Deviation|Mean
14046|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||Percent change||Standard Deviation|Mean
14047|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
14048|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Scores on a scale||Standard Deviation|Mean
14049|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.||Scores on a scale||Standard Deviation|Mean
14050|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Scores on a scale||Standard Deviation|Mean
14051|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population||Participants|||Number
14052|NCT01929317|Secondary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits|The Japanese Unified Parkinson’s Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.||Scores on a scale||Standard Deviation|Mean
14070|NCT01929044|Secondary|Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection|Global assessment of efficacy by the patient. The patient was to assess the efficacy at 120 min after the first injection using a 4-point rating scale by answering the question: “How would you rate the effect of the study medication for relieving your acute gastric or intestinal spasm-like pain?” (0 = poor; 1 = fair; 2 = good; 3 = very good).|120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Percentage of Patients|||Number
16551|NCT01854632|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 8 months post vaccination||||||
14053|NCT01929317|Primary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group|The Japanese Unified Parkinson’s Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline and Week 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.||Scores on a scale||Standard Deviation|Mean
14054|NCT01929135|Secondary|Change in Gingival Index|"Determined as score assigned to each site evaluated respect to clinical criteria as followed:~Score Criteria:~0. No inflammation~Mild inflammation, slight change in color, slight edema, no bleeding on probing.~Moderate inflammation, moderate glazing, redness, bleeding on probing.~Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.~Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated.~The change was calculated as baseline measure minus 1 month later measure."|baseline and 1 month after intervention|||score on a scale||Standard Deviation|Mean
14055|NCT01929135|Secondary|Change in Bleeding on Probing Index (BOP)|"The bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined.~Change in BOP: baseline measure minus 1 month later measure."|baseline and 1 month after intervention|||percentage of BOP||Standard Deviation|Mean
14056|NCT01929135|Secondary|Change in Clinical Attachment Level (CAL)|"The Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual).~Change in CAL: baseline measure minus 1 month later measure."|baseline and 1 month after intervention|||millimeters||Standard Deviation|Mean
14057|NCT01929135|Secondary|Change in Mean Pocket Depth (PD)|"The PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal).~Change in mean PD: baseline measure minus 1 month later measure."|baseline and 1 month later|||millimeters||Standard Deviation|Mean
14058|NCT01929135|Primary|Change in Periodontal Inflammation Surface Area (PISA)|"PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing.~Change in PISA: baseline measure minus 1 month later measure."|baseline and 1 month later of intervention|||square millimeters||Standard Deviation|Mean
14059|NCT01929083|Other Pre-specified|Ratio of Serum Progesterone:Estradiol Concentrations During the Progesterone and Placebo Phases||After 7 days of progesterone or placebo|||Ratio||Standard Deviation|Mean
14060|NCT01929083|Other Pre-specified|Serum Progesterone Concentrations During Progesterone and Placebo Phases||After 7 days of progesterone or placebo|||ng/mL||Standard Deviation|Mean
14061|NCT01929083|Other Pre-specified|Serum Estradiol Concentrations During the Progesterone and Placebo Phases||Following 7 days of progesterone or placebo|||pg/mL||Standard Deviation|Mean
14062|NCT01929083|Other Pre-specified|Maximum (Peak) Serum Ibutilide Concentrations During Progesterone and Placebo Phases||Within 1 hour following ibutilide administration (0, 15 & 30 minutes and 1 hours.)|||pg/mL||Standard Deviation|Mean
14063|NCT01929083|Other Pre-specified|Adverse Effects Associated With Ibutilide in the Progesterone and Placebo Phases||Within 8 hours following ibutilide administration|||percentage of participants|||Number
14064|NCT01929083|Primary|Area Under the QTcI - Time Curve (AUEC)||From beginning of 10-minute ibutilide infusion to 1 hour following ibutilide infusion|||ms*hr||Standard Deviation|Mean
14065|NCT01929083|Primary|Maximum % Change From Baseline in QTcI Intervals Following Ibutilide Administration||After 7 days of progesterone or placebo|||percentage change from baseline value||Standard Deviation|Mean
14066|NCT01929083|Secondary|Incidence of Progesterone-associated Adverse Effects Compared to Placebo||During 7 days of treatment with oral progesterone or placebo|||percentage of participants|||Number
14067|NCT01929083|Primary|Maximum Individual-corrected QT Interval (QTcI)|QT intervals will be corrected as follows: Prior to randomization, subjects will come to the Indiana Clinical Research Center for a 12-hour stay, during which three ECGs, one minute apart, will be obtained at the following times: 0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours. Subjects will be discharged, and then return then next morning for the 24 hour ECG. QT and RR intervals will be used to determine each subject’s individual rate-corrected QT interval (QTcI) using the parabolic model QT = β•RRα, where RR is the interval between adjacent QRS complexes, and α and β are subject-specific correction factors.|0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours post-ibutilide administration|||ms||Standard Deviation|Mean
14068|NCT01929083|Primary|Baseline (Pre-Ibutilide) QTcI Intervals||After 7 days of progesterone or placebo, prior to receiving IV ibutilide|||ms||Standard Deviation|Mean
14069|NCT01929044|Secondary|Proportion of Patients Who Need the Second Injection|Proportion of patients who need the second injection at 20 minutes after the first injection.|20 minutes after the first injection.|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Percentage of Patients||95% Confidence Interval|Number
14091|NCT01928615|Secondary|Overall Survival|Overall survival was defined as the time in months from Baseline to death from any cause.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
16552|NCT01854632|Secondary|Safety Profile of LAIV: Other Non-serious Adverse Events||Through 1 month post vaccination||||||
14071|NCT01929044|Secondary|PID From Pre-dose Baseline at 120 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 120 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
14072|NCT01929044|Secondary|PID From Pre-dose Baseline at 60 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 60 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 60 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
14073|NCT01929044|Secondary|PID From Pre-dose Baseline at 30 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 30 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 30 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
14074|NCT01929044|Secondary|PID From Pre-dose Baseline at 10 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 10 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 10 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.||Units on a scale||Standard Error|Least Squares Mean
14075|NCT01929044|Primary|PID From Pre-dose Baseline at 20 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 20 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 20 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS: all patients who provided any data for the primary efficacy endpoint constituted the full analysis set.), who revealed no important protocol violations that would impact the analysis of primary endpoint||Units on a scale||Standard Error|Least Squares Mean
14076|NCT01928693|Other Pre-specified|Number of Participants With Treatment Failure||29 days|||participants|||Number
14077|NCT01928693|Other Pre-specified|Patient Pain Scores|Patients will be asked to grade the overall pain of the affected eye at each visit on a Scale= 0--None, 1- Mild, 2- Moderate, 3- Severe|Average of 6 times in a 29 day period|||units on a scale|||Number
14078|NCT01928693|Other Pre-specified|Patient Satisfaction Scores|Patient satisfaction outcomes will be assessed using a series of survey questions ranging in both categorical and continuous outcomes. Treatment will be compared using either methods for differences in binomial proportions or the Wilcoxon Rank Sum test. Scale= 0- Very Comfortable, 1- Comfortable, 2- Uncomfortable, 3- Very Uncomfortable|Average of 6 times in a 29 day period|||units on a scale|||Number
14079|NCT01928693|Other Pre-specified|Scarring|Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.|29 days|||millimeters|||Number
14080|NCT01928693|Other Pre-specified|Time to Treatment Failure.|If there is no reduction in size of the corneal ulcer by day 8, the treatment will be deemed a failure and alternative medications will be given at the discretion of the investigator.|8 days|Data was not collected because there were no treatment failures in any of the treatment arms|||||
14081|NCT01928693|Secondary|Healing Rate|Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.|29 days|||Days|||Number
14082|NCT01928693|Primary|Complete Healing|The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.|29 days|||participant|||Number
14083|NCT01928680|Secondary|Number and Severity of Adverse Events of Patients Enrolled in This Trial|Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.|1 year||||||
14084|NCT01928680|Secondary|Overall Survival||3 years||||||
14085|NCT01928680|Secondary|Progression Free Survival||2 years||||||
14086|NCT01928680|Primary|Overall Response Rate||6 months|||percentage of response|||Number
14087|NCT01928615|Secondary|Percentage of Participants Preferring Each Injection Site|Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.|End of Cycle 14 (Week 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
14088|NCT01928615|Secondary|Participant’s Satisfaction With the Injection Site|Each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
14089|NCT01928615|Secondary|Health Care Provider’s Satisfaction With the Injection Site|The health care provider for each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
14090|NCT01928615|Secondary|Disease-free Survival|Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
16553|NCT01854632|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 1 month post vaccination||||||
14092|NCT01928615|Primary|Quality of Life Score|Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.|Cycles 7-14 (Weeks 19-42, 24 weeks total)|"Modified intent-to-treat population: All participants who received at least 1 dose of study medication and who have at least 1 quality of life score in each treatment period (Cycles 7-10 and Cycle 11-14).~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."|||||
14093|NCT01928472|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 through Day 7 after each vaccination.|Analysis was done on the solicited safety set - All subjects in the exposed set with solicited AE data.||Number of subjects|||Number
14094|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.|Day 1 to Day 366.|Analysis was done on unsolicited safety set.||Number of subjects|||Number
14095|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 to Day 43|Analysis was done on unsolicited safety set - All subjects in the exposed set with unsolicited AE data.||Number of subjects|||Number
14096|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.|Day 183 and 366|FAS-Day 183 and FAS-Day 366||Percentages of subjects||95% Confidence Interval|Number
14097|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|"Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.~Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10."|Day 183 and 366|FAS-Day 183 and FAS-Day 366||Percentages of subjects||95% Confidence Interval|Number
14098|NCT01928472|Secondary|Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.|Day 183 and 366|FAS-Day 183 and FAS-Day 366||Ratio||95% Confidence Interval|Geometric Mean
14099|NCT01928472|Secondary|Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.|Day 183 and 366.|FAS-Day 183 and FAS-Day 366||Titers||95% Confidence Interval|Geometric Mean
14100|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.|Day 1 and 22.|FAS-Day 22||Percentages of subjects||95% Confidence Interval|Number
14101|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.~Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 22|FAS-Day 22||Percentages of subjects||95% Confidence Interval|Number
14102|NCT01928472|Secondary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.|Day 22|FAS-Day 22||Ratio||95% Confidence Interval|Geometric Mean
14103|NCT01928472|Secondary|Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)|Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.|Day 1 and 22|FAS-Day 22||Titers||95% Confidence Interval|Geometric Mean
14104|NCT01928472|Primary|Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.|Day 1 and 43|FAS-Day 43.||Percentages of subejcts||95% Confidence Interval|Number
14105|NCT01928472|Primary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.~Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 43|FAS-Day 43||Percentages of subjects||95% Confidence Interval|Number
14191|NCT01925170|Primary|Cancer Detection Rate Per 1000 Women Screened, by Breast Density|The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.|Within 21 days of mammography|||cancers per 1000 women screened||95% Confidence Interval|Number
14107|NCT01928472|Primary|Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)|Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination|Day 1 and 43|The analysis was done on Full Analysis Set – Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).||Titers||95% Confidence Interval|Geometric Mean
14108|NCT01928381|Post-Hoc|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day home diary + in clinic assessment at end of 3 week treatment)|3 weeks of treatment|Per Protocol||Average daily pain score||Standard Error|Least Squares Mean
14109|NCT01928381|Primary|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)|3 weeks of treatment|Full Analysis set||Average daily pain score||Standard Error|Least Squares Mean
14110|NCT01928030|Secondary|Reduction in Forearm Volume|Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume|Up to 1 year||||||
14111|NCT01928030|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|Related adverse events reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment.|Up to 1 year|||Participants|||Count of Participants
14112|NCT01927757|Secondary|Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.|Baseline, week 12 and week 24|"Full analysis set participants who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in each analysis."||units on a scale||Standard Deviation|Mean
14113|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 24|Full analysis set; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
14114|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 12|Full analysis set; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
14115|NCT01927757|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||units on a scale||Standard Deviation|Mean
14116|NCT01927757|Secondary|Percentage of Participants With DAS 28-CRP < 3.2|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity.|Weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
14117|NCT01927757|Secondary|Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity.|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
14118|NCT01927757|Secondary|Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100.~The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement."|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.||units on a scale||Standard Deviation|Mean
14119|NCT01927757|Secondary|Percentage of Participants With an ACR 70 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
14120|NCT01927757|Secondary|Percentage of Participants With an ACR 50 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
14121|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 24|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
14122|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
14123|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
14124|NCT01927757|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data||percentage of participants||95% Confidence Interval|Number
14125|NCT01927419|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Select AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment to within 30 days past last dose|All participants who received at least 1 dose of study drug||Participants|||Number
14126|NCT01927419|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) Score|Health-related QOL was measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/quality of life composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 questionnaire, Version 3. The EORTC QLQ-C30 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool covering multiple items, including 5 functional scales (physical, role, emotional, social, and cognitive); 3 symptom scales (fatigue, nausea and vomiting, and pain); a global health status/QOL scale; and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for each item range from 0 to 100. A high score for a functional scale represents a high (healthy) level of functioning, and a high score for the global health status represents a high QOL. However, a high score for a symptom scale represents more severe symptoms.|From Baseline to Week 25|All randomized participants. n=number of participants evaluable||Units on a scale||Standard Deviation|Mean
14127|NCT01927419|Secondary|Percentage of BRAF Mutation-positive Participants With Investigator-assessed Objective Response|Objective Response is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR); percentage is determined by that total divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All BRAF mutation-positive participants||Percentage of participants||95% Confidence Interval|Number
14128|NCT01927419|Secondary|Investigator-assessed Progression-free Survival (PFS) in All Populations|PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, or death due to any cause, whichever occurs first. WT=wild type|Date of randomization to disease progression or death, whichever occurs first, to approximately 10 months|All randomized participants||Months||95% Confidence Interval|Median
14129|NCT01927419|Secondary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population|Objective Response Rate is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized participants||Percentage of participants||95% Confidence Interval|Number
14130|NCT01927419|Primary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population|Objective Response Rate is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized BRAF wild-type patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized BRAF wild-type participants .||Percentage of participants||95% Confidence Interval|Number
14131|NCT01927055|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.|Change from Randomization to Week 1|"Patients entering the double-blind, randomized phase and having a visit at week 1 of the double-blind phase were analyzed.~Study was stopped when only 5% of planned participants had completed the study to prevent competition with FDA mandated post-marketing requirement study."||units on a scale||Standard Deviation|Mean
14132|NCT01926977|Secondary|Patients With Post Injection Pain Score of One or Higher on Pain Scale|Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)|||participants|||Number
14133|NCT01926977|Primary|Evidence of Anterior Chamber Inflammation|Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)|||participants|||Number
14134|NCT01926626|Other Pre-specified|Tolerability of Moclobemide + Nicotine Patch|Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.||participants|||Number
14135|NCT01926626|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.|The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).|Baseline and 1 week|Participants who received Moclobemide.||percentage of change||Standard Error|Mean
14136|NCT01926626|Other Pre-specified|Safety of Moclobemide + Nicotine Patch|"Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > moderate."|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.||participants|||Number
14137|NCT01926626|Secondary|Percentage of Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day|||percentage of change||Standard Error|Mean
14138|NCT01926626|Secondary|Continuous Ten Week Abstinence From Smoking|Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.|10 weeks post quit day|||participants|||Number
14139|NCT01926626|Secondary|Point Abstinence From Smoking at Six Months Post Quit|Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.|7 day point abstinence from smoking at six months post quit|||participants|||Number
14140|NCT01926626|Primary|Continuous Four-week Abstinence From Smoking|Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).|Weeks 6-10 post quit day|||participants|||Number
14188|NCT01925170|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI.|12 months after mammography and MBI|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and MBI).||percentage of participants||95% Confidence Interval|Number
14141|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 3 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||NA Titer||95% Confidence Interval|Geometric Mean
14142|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 2 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||NA Titer||95% Confidence Interval|Geometric Mean
14143|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 1 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||NA Titer||95% Confidence Interval|Geometric Mean
14144|NCT01926015|Secondary|Geometric Mean Titers for Pertussis FHA Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||EU/mL||95% Confidence Interval|Geometric Mean
14145|NCT01926015|Secondary|Geometric Mean Titers for Pertussis Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||EU/mL||95% Confidence Interval|Geometric Mean
14146|NCT01926015|Secondary|Geometric Mean Titers for Tetanus Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||IU/mL||95% Confidence Interval|Geometric Mean
14147|NCT01926015|Secondary|Geometric Mean Titers for Diphtheria Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||IU/mL||95% Confidence Interval|Geometric Mean
14148|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.||Percentage of participants|||Number
14149|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.||Percentage of participants|||Number
14150|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.||Percentage of participants|||Number
14192|NCT01924975|Secondary|Before Attempts of the Cannulation Are Made, Investigators Will Measure the Diameter of the Saphenous Vein With Ultrasound Imaging to Determine if There is Correlation Between Size of the Vein and Success Rate.||10 minutes||||||
14151|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Fever|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.||Percentage of participants|||Number
14152|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event With Incidence >=1%|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded.|Up to 14 days after any of the 6 study visits|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was were counted only once overall.||Percentage of participants|||Number
14153|NCT01926015|Primary|Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3|Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer >=8.|4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint||Percentage of participants|||Number
14154|NCT01925781|Secondary|Point Prevalence Abstinence|No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.|12 weeks|||participants|||Number
14155|NCT01925781|Primary|Sustained Abstinence|No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.|12 weeks|||participants|||Number
14156|NCT01925768|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Start of the lst dose of IP to the end of the PBO controlled phase; Weeks 0-24 for those randomized to APR 30 mg; Weeks 0-24 for those randomized to PBO who did not enter EE at Week 16; Weeks 0-16 for those randomized to PBO who entered EE at Week 16|Safety population includes all participants who were randomized and received at least one dose of IP||Participants|||Number
14157|NCT01925768|Secondary|Change From Baseline in the Severity of Morning Stiffness at Weeks 52 and 104|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Weeks 52 and 104||11/2017||||
14158|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Weeks 52 and 104||11/2017||||
14159|NCT01925768|Secondary|Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Component Scores and Summary Score at Weeks 52 and 104|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Weeks 52 and 104||11/2017||||
14160|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Weeks 52 and 104||11/2017||||
14189|NCT01925170|Secondary|Sensitivity for All Cancers Diagnosed|Sensitivity measures the percentage of actual positives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified cancer status at 12 months after the initial screening. 21 participants out of the total study population of 1585 were diagnosed with cancer.||percentage of actual positives||95% Confidence Interval|Number
14193|NCT01924975|Secondary|Investigators Will Measure the Required Time for the Successful Venous Cannulation Between Groups.||10 minutes||||||
14161|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Weeks 52 and 104|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Weeks 52 and 104||11/2017||||
14162|NCT01925768|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Weeks 52 and 104||11/2017||||
14163|NCT01925768|Secondary|Percentage of Participants Who Achieve an ACR 20 Response at Weeks 2, 4, 6, 8, 12 and 20|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and at Weeks 2, 4, 6, 8, 12 and 20||11/2017||||
14164|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Week 16||11/2017||||
14165|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Week 16|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Week 16||11/2017||||
14166|NCT01925768|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2.0 Physical Functioning Domain at Week 16|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16||11/2017||||
14167|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Week 16||11/2016||||
14168|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 16||11/2017||||
14169|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 24 Improved From Baseline|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Week 24||11/2017||||
14170|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Week 24|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Week 24||11/2017||||
14171|NCT01925768|Secondary|Change From Baseline in the SF-36V2 Physical Component Summary Score at Week 24|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24||11/2017||||
14172|NCT01925768|Secondary|Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score Change at Week 24|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24||11/2017||||
14173|NCT01925768|Secondary|Change From Baseline in the 28-joint Disease Activity Score Using C-reactive Protein as the Acute-phase Reactant (DAS28 [CRP]) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Week 24||11/2017||||
14174|NCT01925768|Secondary|Percentage of Participants Who Achieve an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Week 24||11/2017||||
14175|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 24||11/2017||||
14176|NCT01925768|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Week 16|FAS population consisting of all participants randomized as specified in the protocol; Those who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders. Non-responder imputation (NRI)||percentage of participants|||Number
14177|NCT01925703|Secondary|Serum Ferritin Level|Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All participants who achieved complete iron repletion for whom follow up data were available.||nanograms per milliliter||95% Confidence Interval|Mean
14178|NCT01925703|Secondary|Transferrin Saturation|Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow-up data were available.||Percentage of transferrin saturation||95% Confidence Interval|Mean
14179|NCT01925703|Primary|Serum Hemoglobin Concentration|Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow up data were available.||grams per deciliter||95% Confidence Interval|Mean
14180|NCT01925417|Secondary|Post-treatment Hospitalization Data|number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.|6 months|31 subjects had evaluable data at 6 months.||number of particpants' ICU days||Full Range|Median
14181|NCT01925417|Secondary|Quality of Life|Quality of life will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.|60 days||||||
14182|NCT01925417|Secondary|Absence of CDAD at 56 Days|Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.|56 days|31 subjects had evaluable data at 56 days.||participants with treatment success|||Number
14183|NCT01925417|Secondary|Long-term Safety|The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.|6 months|31 subjects had evaluable data at 6 months.||number of reported SAEs|||Number
14184|NCT01925417|Primary|Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660|Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.|56 days|31 subjects had evaluable data at 56 days.||number of reported SAEs through 56 days|||Number
14185|NCT01925183|Primary|Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline (BL) to Follow-up week 12 (FU12)|||Participants|||Count of Participants
14186|NCT01925183|Primary|Sustained Virologic Response (SVR12)|Defined as HCV-RNA negativity by a sensitive assay|Follow-up week 12 (FU12)|||Participants|||Count of Participants
16554|NCT01854632|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through 7 days post vaccination||||||
14196|NCT01924949|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
14197|NCT01924949|Secondary|HCV RNA Change From Baseline||Baseline; Weeks 1, 4, and 8|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
14198|NCT01924949|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 weeks|Full Analysis Set||percentage of participants|||Number
14199|NCT01924949|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
14200|NCT01924949|Primary|Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
14201|NCT01924949|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
14202|NCT01924871|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.||||||
14203|NCT01924871|Secondary|Success Rate & Complication Rate Including Cough|We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.|assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.||||||
14204|NCT01924871|Primary|Awakening Time|The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening|Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.|||minutes||Inter-Quartile Range|Median
14205|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for Emax0-5, Emax0-12, Emin0-5 and Emin0-12.~Emax: Maximum effect (maximum measured concentration of glucose or insulin in plasma) & Emin: Minimum effect (minimum measured concentration of glucose or insulin in plasma)"|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS||µU/mL||Standard Deviation|Mean
14206|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for AUEC0-5 and AUEC0-12. AUEC0-5: The area under the effect concentration-time curve over the time interval 0 to 5.~AUEC0-12: The area under the effect concentration-time curve over the time interval 0 to 12."|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS||µU*h/mL||Standard Deviation|Mean
14207|NCT01924767|Secondary|Fasting Plasma Glucose|Percentage change from baseline to Day 8 in fasting plasma glucose. Baseline is defined as Day -2.|-0:30 (Pre dose samples)|PDS||percentage of fasting plasma glucose||Standard Deviation|Mean
14208|NCT01924767|Secondary|Mean Daily Glucose|Change from baseline to Day 8 in mean daily glucose. Baseline is defined as Day -2.|0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8|PDS||mg/dL||Standard Deviation|Mean
14209|NCT01924767|Secondary|Change From Baseline to Day 8 in Urinary Glucose Excretion|Change from baseline to day 8 in urinary glucose excretion. Baseline is defined as Day -2.|-2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8|Pharmacodynamic (PD) analysis set (PDS) contains of all patients who received study medication and have evaluable pharmacodynamic parameter data.||mg||Standard Deviation|Mean
14210|NCT01924767|Secondary|Accumulation Ratios|"Accumulation ratio based on Cmax (RA,Cmax) and Accumulated ratio based on AUC0-tau (RA,AUC) at steady-state.~Accumulation ratio for the respective doses were calculated using below mentioned equations:~RA,Cmax = Cmax,ss/Cmax~RA,AUC= AUCtau,ss/AUCtau"|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||Ratio||Geometric Coefficient of Variation|Geometric Mean
14211|NCT01924767|Secondary|Linearity Index|The linearity index is defined as AUC0-tau divided by AUC0-∞ both at steady state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||Fraction||Geometric Coefficient of Variation|Geometric Mean
14212|NCT01924767|Secondary|Peak Trough Fluctuation|Peak trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||PTF(%) of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
14213|NCT01924767|Secondary|Apparent and Renal Clearance of the Analyte in Plasma|"Apparent clearance of the analyte in plasma (CL/F) after first dose and at steady-state, Renal clearance of the analyte in plasma after extravascular administration (CLR) after first dose and at steady-state.~Apparent clearance after first dose is defined as the dose divided by AUC0-∞; apparent clearance at steady-state is defined as the dose divided by AUC0-tau at steady-state.~Renal clearance CLR(0-t) is defined as Ae0-t divided by AUC0-t."|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||mL/min||Geometric Coefficient of Variation|Geometric Mean
16555|NCT01854632|Secondary|Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.||Through 30 minutes post vaccination||||||
14214|NCT01924767|Secondary|Fraction of Analyte Excreted Unchanged in Urine|"Fraction of analyte excreted unchanged in urine in the time interval 0 to 12 h (fe0-12) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-12 by the Dose and multiply it with 100.~Fraction of analyte excreted unchanged in urine in the time interval 0 to 24 h (fe0-24) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-24 by the Dose and multiply it with 100."|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set||percent of analyte||Geometric Coefficient of Variation|Geometric Mean
14215|NCT01924767|Secondary|Amount of Analyte Eliminated in Urine|Amount of analyte that is eliminated in urine after first dose and at steady state from the time interval 0 to 24 h (Ae0-24) and 0 to 48 h (Ae0-48)|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set||nmol||Geometric Coefficient of Variation|Geometric Mean
14216|NCT01924767|Secondary|Apparent Volume of Distribution During the Terminal Phase|Apparent volume of distribution during the terminal phase (Vz/F) after first dose and at steady state. Apparent volume is defined as CL/F divided by the terminal rate constant in plasma (either after first dose or at steady-state).|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||L||Geometric Coefficient of Variation|Geometric Mean
14217|NCT01924767|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half life of the analyte in plasma (t1/2) and mean residence time of the analyte in the body after single oral administration (MRTpo) after first dose and at steady-state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK Set||h||Geometric Coefficient of Variation|Geometric Mean
14218|NCT01924767|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||1/h||Geometric Coefficient of Variation|Geometric Mean
14219|NCT01924767|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of the analyte in plasma (tmax) after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||h||Full Range|Median
14220|NCT01924767|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)|AUC0-∞: from 0 extrapolated to infinity after first dose AUCtau,1: over a uniform dosing interval tau after first dose AUCtau,ss: over a uniform dosing interval tau at steady-state AUCs were computed using the linear up/log down algorithm. If an analyte concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was to be used. If the analyte concentration was smaller than the preceding concentration, the logarithmic method was to be used.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
14221|NCT01924767|Secondary|Concentration of the Analyte in Plasma|Maximum concentration of the analyte in plasma (Cmax) after first dose, Maximum, minimum (Cmin) and average (Cavg) concentration of the analyte in plasma at steady-state, Concentration of analyte in plasma at 24 h after administration of the 8th dose (at steady-state) (C24,8)|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|Pharmacokinetic set (PK set) contains of all patients who received study medication and have evaluable pharmacokinetic parameter data. The PK set will not contain placebo patients.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
14222|NCT01924767|Primary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.|day 21|Treated set||percentage of participants|||Number
14223|NCT01924767|Primary|Micturition Frequency|Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.|Baseline and Day 9|Treated set||frequency of micturition||Standard Deviation|Mean
14224|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results|Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results|day 1 to day 21|Treated set||percentage of participants|||Number
14225|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests|Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|day 1 to day 21|Treated set.||percentage of participants|||Number
14226|NCT01924559|Primary|Time to Successful Intubation|Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute|approximately one minute|EM Residents who tested/participated in each of the six groups||seconds||Full Range|Mean
14227|NCT01924390|Other Pre-specified|Change in Ridge Width and Ridge Height|Ridge width and height are measured at time of tooth extraction & grafting, and again 18-20 weeks later at time of implant placement. Changes in ridge height and width are determined.|At time of implant placement, which is 18-20 weeks after grafting of extraction socket|||change in ridge width (loss of width mm)||Standard Deviation|Mean
14228|NCT01924390|Secondary|Percent Residual Graft Material and Percent Connective Tissue|Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue|18-20 weeks|||percentage of residual graft||Standard Deviation|Mean
14229|NCT01924390|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|18-20 weeks|||percentage of vital bone||Standard Deviation|Mean
14233|NCT01924182|Primary|Clinical Success|Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the primary outcome assessment, no statistical analysis will be presented.||participants|||Number
14234|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 13|||percentage of inappropriate behaviors||Inter-Quartile Range|Median
14235|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 1|||percentage of inappropriate behaviors||Inter-Quartile Range|Median
14236|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 13|All subjects completed up to meal 13.||percentage of bites||Inter-Quartile Range|Median
14237|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 1|||percentage of bites||Inter-Quartile Range|Median
14238|NCT01923467|Primary|Acceptance of Offer to Join Stop Smoking Program|After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.|1 Day of Enrollment|||participants|||Number
14239|NCT01923389|Secondary|Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Rac for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
14240|NCT01923389|Secondary|Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|t1/2 for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
14241|NCT01923389|Secondary|Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|CL for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
14242|NCT01923389|Secondary|Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Tmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.|||||
14243|NCT01923389|Secondary|Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cav for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not reported due to the premature termination of the study.|||||
14244|NCT01923389|Secondary|Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cmin for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.|||||
14245|NCT01923389|Secondary|Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|Cmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.|||||
14246|NCT01923389|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|AUCtau for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.|||||
14247|NCT01923389|Primary|Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.|Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.|Days 1 up to the last follow-up (Day 68)|All participants who received at least 1 dose of active study medication (PF-05231023). Neutralizing antibodies were not tested because all participants who received PF-05231023 100 mg tested negative for anti-PF-05231023 antibodies.||Participants|||Number
14248|NCT01923389|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
14249|NCT01923389|Primary|Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia’s formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
14250|NCT01923389|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
14251|NCT01923389|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.|Day -7 through the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).||Participants|||Number
14252|NCT01922349|Secondary|RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
14253|NCT01922349|Secondary|RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS||Ratio of Cmax||Geometric Coefficient of Variation|Geometric Mean
14254|NCT01922349|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||hours||Geometric Coefficient of Variation|Geometric Mean
14255|NCT01922349|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
14256|NCT01922349|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||hours||Full Range|Median
14257|NCT01922349|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
14258|NCT01922349|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)|Terminal half-life of the analyte in plasma after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|PKS||hours||Geometric Coefficient of Variation|Geometric Mean
14259|NCT01922349|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
14260|NCT01922349|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
14261|NCT01922349|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)|Time from dosing to maximum measured concentration in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||hour||Full Range|Median
14262|NCT01922349|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|maximum measured concentration of the analyte in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
14263|NCT01922349|Primary|Number (%) of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.|Up to 21 days (4 days for SRD period and 17 days for MRD period)|Treated set (TS)||Percentage of participants|||Number
14264|NCT01922271|Secondary|Inspiratory Capacity (IC)|Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
14265|NCT01922271|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
14266|NCT01922271|Secondary|Residual Volume (RV)|Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
14267|NCT01922271|Secondary|Functional Resistance Capacity (FRCpleth)|Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||Liters||Standard Deviation|Mean
14268|NCT01922271|Secondary|Specific Airway Resistance (sRAW)|Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||kilopascal (kPa)||Standard Deviation|Mean
14269|NCT01922271|Secondary|Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||liters per hour||Standard Deviation|Mean
14270|NCT01922271|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2|Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.||liters per hour||Standard Deviation|Mean
14271|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.|Week 4|||percentage of total correct||Standard Deviation|Mean
14272|NCT01922115|Secondary|Overactive Bladder Questionnaire|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes.|Week 4|||units on a scale||Standard Deviation|Mean
14273|NCT01922115|Secondary|Mini–Mental State Examination|The mini–mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes.|Week 4|||units on a scale||Standard Deviation|Mean
14274|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.|Week 4|||units on a scale||Standard Deviation|Mean
14275|NCT01922089|Secondary|Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).|Tolerability was assessed as the number of participants who achieved LCZ696 200 mg bid and maintained this dose for at least 2 weeks before study completion, regardless of previous dose interruption or down-titration and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||participants|||Number
14276|NCT01922089|Secondary|Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Treatment success was defined as the number of participants who achieved and maintained LCZ696 200 mg bid without any dose interruption or down-titration over 12 weeks and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||participants|||Number
15917|NCT01875159|Primary|Episodes of Intermittent Hypoxia Per Hour|Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat||Events per hour||Standard Deviation|Mean
14277|NCT01922089|Primary|Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Full Analysis Set (FAS) consisted of all randomized patients with the exception of mis-randomized patients who had not received the study drug, but had been inadvertently randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||participants|||Number
14278|NCT01920568|Secondary|Serum Concentration of Denosumab on Day 1, at Week 2, Week 5, Week 9, Week 13, Week 17, Week 19, Week 21, Week 25 and Week 49|Blood samples were drawn on study Day 1, pre-dose; 4 hours, 24 hours, and at Week 2 (168 hours); then pre-dose at Week 5, Week 9, Week 13, Week 17, Week 19 (no dose), Week 21, Week 25, and Week 49.|Samples were collected at pre-dose (Day 1); 4 hours, 24 hours, 168 hours post-dose; pre-dose at Week 5, Week 9, Week 13, Week 17; Week 19 (at 336 hours); pre-dose at Week 21, Week 25, Week 49|Pharmacokinetic (PK) Population: comprised of participants who signed informed consent to participate in the PK sub-study and who had their PK parameters evaluable according to GSK standards. Only those participants with evaluable parameters are included (represented by n=X in the category titles).||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
14279|NCT01920568|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Day 1, Week 25 and Week 53.|Anti-denosumab antibody formation was assessed at Day 1, Week 25 and Week 53. Binding antibody assay was used to assess number of participants with anti-denosumab antibody.|Day 1, Week 25 and Week 53|FAS-Safety Population. Only those participants on whom anti-denosumab antibody formation was analyzed at specified time point is presented (represented by n=X, X in the category titles).||Participants|||Number
14280|NCT01920568|Secondary|Number of Participants With Worst-case On-therapy Increase in the Indicated Hematology Parameters From Baseline Grade to the Indicated Grade.|Hematology parameters included hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell (WBC) count. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy lab values were available (represented by n=X, X in the category titles) were analyzed.||Participants|||Number
14281|NCT01920568|Secondary|Number of Participants With Worst-case (WC) On-therapy Increase in the Indicated Clinical Chemistry Parameters From Baseline Grade to the Indicated Grade.|Clinical chemistry parameters were measured at the Screening and Weeks 2, 5, 9, 13, 25, 37, and 53 visits. Clinical chemistry parameters measured on-study included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium (Ca), creatinine, magnesium, and phosphorous (P) inorganic. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) was used for grading. Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy laboratory values were available (represented by n=X, X in the category title) were analyzed.||Participants|||Number
14282|NCT01920568|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, non-fatal SAEs, fatal SAEs have been presented.|From start of IP through the Study Phase (49 weeks post-dose) (assessed up to 73 weeks)|Full-Analysis-Set Safety (FAS-Safety) Population: comprised of all randomized participants who received at least one dose of study treatment and was based on the actual study treatment received (if this differed from that to which the participant was randomized).||Participants|||Number
14283|NCT01920568|Secondary|Percent Change From Baseline in the Serum Bone-specific Alkaline Phosphatase (s-BALP) at Week 13.|Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Indicated visit minus Baseline value. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100.|Baseline and Week 13|FAS-ITT Population. All participants who were randomized and had a observed values at Baseline and Week 13 were used in the analysis.||Percent change||Full Range|Median
14298|NCT01921101|Primary|Infection|All new infections that occurred (including blood, wound, sputum, urinary tract and pulmonary) from enrollment through hospital discharge recorded in the medical record were counted|Assessed daily from study enrollment through hospital discharge, an average of 3 weeks|||participants|||Number
14420|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set||percentage (%) of subjects|||Number
14284|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Participants With Advanced Breast Cancer.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in breast cancer par. with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Participants with advanced breast cancer.||Percent change||95% Confidence Interval|Least Squares Mean
14285|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Chinese Participants.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Chinese ancestry with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Chinese participants.||Percent change||95% Confidence Interval|Least Squares Mean
14286|NCT01920568|Primary|Percent Change (Chg) From Baseline (BL) to Week (Wk)13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr)|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment (trt). uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Primary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Asian ancestry with bone metastases from solid tumors. BL value is the most recent, non-missing value prior to or on the 1st study trt dose date. Chg from BL is the value at Wk13 minus BL value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline (BL) and Week (Wk) 13|Full-Analysis-Set Intent-to-Treat (FAS-ITT) Population: comprised of all randomized participants regardless of whether or not study treatment was administered. Only those participants with values at Baseline and Week 13 were included in the analysis.||Percent change||95% Confidence Interval|Least Squares Mean
14287|NCT01921452|Primary|Concentration of TSH in Whole Blood||Day 1 up to Day 5|The FAS included all enrolled participants.||Milli international units per liter||Standard Deviation|Mean
14288|NCT01921452|Primary|Number of Participants With Positive and Negative TSH Test Result||Day 1 up to Day 5|The FAS included all enrolled participants. ‘n’ signifies number of participants who were evaluable for this measure for the specified category.||Participants|||Number
14289|NCT01921296|Other Pre-specified|Percentage of Patients That Experience Adverse Events|Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria|24 weeks|||percentage of participants|||Number
14290|NCT01921296|Other Pre-specified|Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy|We will assess the number of patients who continue to take the original aromatase inhibitor medication at the 24 week timepoint, as assessed using patient self-report and medical records|24 weeks|||percentage of participants|||Number
14291|NCT01921296|Secondary|Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment||change in average pain||Full Range|Mean
14292|NCT01921296|Secondary|Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment||change in T score||Full Range|Mean
14293|NCT01921296|Primary|Number of Patients That Experience an Improvement in Sleep Quality as Assessed Using the Pittsburgh Sleep Quality Index (PSQI) With 8 Weeks of Cyclobenzaprine Therapy.|Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine. A total score is calculated for the Pittsburgh Sleep Quality Index. The total score ranges from 0-21, with higher scores representing worse sleep quality. Any reduction in PSQI total score was considered an improvement.|8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment||participant|||Number
14294|NCT01921101|Other Pre-specified|Immune Parameters|Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14|baseline and weekly while hospitalized||||||
14295|NCT01921101|Secondary|Death|The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge|date of occurence|||participants|||Number
14296|NCT01921101|Secondary|Days on Mechanical Ventilation|the total number of days requiring mechanical ventilation while hospitalized|days||||||
14297|NCT01921101|Secondary|Length of Hospital Stay|The total number of days the patient is in the hospital|days in hospital||||||
14299|NCT01920958|Secondary|Percentage of Participants With Post-Operative Complications and Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
14300|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
14301|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced|Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
14302|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
14303|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
14304|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time|Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.|Peri- and post-surgery (Up to 50 Days)|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.||percentage of participants|||Number
14305|NCT01920958|Secondary|Length of Hospital and ICU Stay|Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.|Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||days||Standard Deviation|Mean
14306|NCT01920958|Secondary|Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume||Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||percentage of participants|||Number
14307|NCT01920958|Secondary|Percentage of Participants With at Least One Drainage Inserted|The total number of participants where at least one drainage was used during the operation.|Baseline (Day of Surgery)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||percentage of participants|||Number
14308|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale|The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||score on a scale||Standard Deviation|Mean
14309|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale|The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||score on a scale||Standard Deviation|Mean
14310|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale|The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.||score on a scale||Standard Deviation|Mean
14311|NCT01920958|Primary|Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge||Up to 50 Days|Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery.||percentage of participants|||Number
14312|NCT01920854|Primary|Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6|The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)|Baseline (1 day)|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||mg/dL||Standard Deviation|Mean
14369|NCT01918371|Secondary|Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye|Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.|Up to 4 Years|All participants with data available.||percentage of participants|||Number
14313|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)|"Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||dL||Standard Deviation|Mean
14314|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)|"Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||hours||Standard Deviation|Mean
14315|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)|"Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||1/hour||Standard Deviation|Mean
14316|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)|"Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL/mg||Standard Deviation|Mean
14317|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)|"Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||hours||Full Range|Median
14318|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)|"Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||microgram/dL||Standard Deviation|Mean
14319|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])|"Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||dL/hour||Standard Deviation|Mean
14320|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)|"Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||h*microgram/dL||Standard Deviation|Mean
14370|NCT01918371|Secondary|Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye||UP to 4 Years|All participants with data available.||percentage of participants|||Number
14321|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)|"Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||h*microgram/dL||Standard Deviation|Mean
14322|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14323|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14324|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14325|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14326|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14327|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14328|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||percentage of saturation||Standard Deviation|Mean
14329|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||percentage of saturation||Standard Deviation|Mean
14330|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14331|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14332|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14333|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.||micrograms/dL||Standard Deviation|Mean
14334|NCT01920282|Other Pre-specified|Oxidized LDL Concentration||12 weeks||||||
14335|NCT01920282|Secondary|Insulin Sensitivity (HOMA-IR)|The HOMA index was calculated as the product of plasma blood glucose and insulin divided by 22.5.|12 weeks|||Arbitrary units||Standard Error|Mean
14336|NCT01920282|Primary|Beta-stiffness Index|Longitudinal B-mode images of the left common carotid artery diameter (1-2 cm proximal to the carotid bulb) were obtained over 15 consecutive cardiac cycles. Brachial blood pressure was measured via an automated sphygmomanometer. Quantification of systolic and diastolic carotid artery diameters were analyzed with the Vascular Research Tools 5 software program. Beta-stiffness index was calculated as: Beta = ln(P1/P0)/((D1-D0)/D0), where D0 represents the minimal diameter recorded during diastole, D1 represents the maximal diameter recorded during systole, P0 represents the pressure measured during diastole, and P1 represents the pressure measured during systole.|12 weeks|||Arbitrary units||Standard Error|Mean
14337|NCT01919996|Secondary|Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations|Clinically significant change (improvement or worsening) is based on five ophthalmic exams at baseline and the final visit. Any 1 or more of these conditions are a clinically significant change: 1) A worsening in BCVA (distance), as defined in outcome measure 1 OR an improvement in BCVA (distance) as defined in outcome measure 2. 2) A worsening in color vision (FM-100), as defined in outcome measure 1 OR an improvement in color vision (FM-100) as defined in outcome measure 2. 3) A worsening in Amsler Grid, as defined in outcome measure 1, OR an improvement in Amsler Grid, as defined in outcome measure 2. 4) A worsening in anterior segment biomicroscopy, as defined in outcome measure 1 OR an improvement in anterior segment biomicroscopy as defined in outcome measure 2. 5) A worsening in dilated indirect ophthalmoscopy, as defined in outcome measure 1 OR an improvement in dilated indirect ophthalmoscopy as defined in outcome measure 2.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).||percentage of participants|||Number
14338|NCT01919996|Secondary|Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations|1 or more of these conditions are clinically significant improvement based on five ophthalmic exams:1) clinically significant improvement in BCVA(distance) at the final visit, in either eye, defined as an increase in score of 5 or more letters from baseline in ETDRS BCVA.2) Assessment of abnormal clinically significant at baseline and normal or abnormal, non-clinically significant at final visit in color vision(FM-100) in either eye. 3) Assessment of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5)Assessments of abnormal clinically significant at baseline and normal/abnormal, nonclinically significant at final visit in dilated ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).||percentage of participants|||Number
14339|NCT01919996|Primary|Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations|Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).||percentage of participants|||Number
14340|NCT01919801|Other Pre-specified|Area Under the Plasma Concentration Versus Time Curve (AUC[0-24]) of Icatibant and Its Metabolites (M1 and M2)|Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC[0-24]).|0.75 and 2 hours post-dose|PK analysis population.||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
14341|NCT01919801|Other Pre-specified|Maximum Observed Serum Concentration (Cmax) of Icatibant and Its Metabolites (M1 and M2)|Cmax is the peak plasma concentration of a drug after administration.|0.75 and 2 hours post-dose|Pharmacokinetic (PK) analysis included all participants in the safety population who received study drug and provided evaluable plasma drug concentrations.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
14342|NCT01919801|Secondary|Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|4, 6, and 8 hours post treatment|mITT population.||percentage of participants|||Number
14343|NCT01919801|Secondary|Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration|Number of participants with the use of conventional medications (corticosteroids, antihistamines, epinephrine) for the treatment of symptoms of the ACE-I- induced angioedema attack following study drug administration were presented.|Day 0 up to Day 5|mITT population.||participants|||Number
14344|NCT01919801|Secondary|Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)|Number of participants with and without an occurrence of admission to the hospital (inpatient) or ICU post-treatment due to the ACE-I-induced angioedema attack were described.|Day 0 up to Day 5|mITT population.||participants|||Number
14345|NCT01919801|Secondary|Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema|Airway Intervention included intubation, tracheotomy, cricothyrotomy.|Day 0 up to Day 5|Modified Intent to treat (mITT) population included all randomized participants who received the study drug.||participants|||Number
14346|NCT01919801|Secondary|Time to Onset of Symptom Relief (TOSR)|TOSR was calculated for the individual symptoms with pre-treatment scores of 2 (moderate) or more improved by at least 1 severity grade and the individual symptoms with pretreatment scores of 0 or 1 (absent or mild) were scored again at 0 or 1 and all the subsequent assessments continued to satisfy this condition. Time-to-event data were summarized using Kaplan-Meier estimates.|Day 0 up to Day 5|ITT population.||days||Inter-Quartile Range|Median
14371|NCT01918371|Secondary|Number of Intravitreal Anti-VEGF Injections in the Study Eye|To be included in the time period analysis, patients must have been enrolled on the study for at least a minimum of 0 weeks, 24 weeks, 50 weeks, 100 weeks, and 150 weeks, respectively, and must have received at least 1 injection during that time period.|0-6 Months, 7-12 Months, Years 1,2,3|All participants with data available.||injections||Standard Deviation|Mean
14347|NCT01919801|Primary|Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination|During laboratory evaluation, serum chemistry and hematology blood tests, and urinalysis were performed. Vital signs parameters included evaluation of pulse rate and systolic and diastolic blood pressure. Standard 12-lead ECGs were performed and ECG recordings were read locally at the study site by a cardiologist. Physical examination was performed with examination of major body systems per routine clinical practice.|Day 0 to Day 5|Safety population.||participants|||Number
14348|NCT01919801|Primary|Number of Participants With Treatment Emergent Injection Site Reaction|Injection site reaction included erythema, swelling, cutaneous pain, burning sensation, itching and warm sensation|Day 0 to Day 5|Safety population.||participants|||Number
14349|NCT01919801|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study drug administration (Day 0) up to follow-up (Day 5)|Safety population included all participants who received the study drug.||participants|||Number
14350|NCT01919801|Primary|Time to Meeting Discharge Criteria (TMDC)|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|Day 0 up to Day 5|Intent-to-treat (ITT) population included all randomized participants.||days||Inter-Quartile Range|Median
14351|NCT01919606|Secondary|Incidence of Adverse Events||10 days post surgery plus or minus 3 days|||number of events|||Number
14352|NCT01919606|Primary|Duration of Analgesia||End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)||||||
14353|NCT01919229|Secondary|Change From Baseline in Expression of Cyclin-Dependent Kinase 1 (CDK1)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.|||||
14354|NCT01919229|Secondary|Correlation Between PK Concentrations and ECG Changes|Correlation between the QTc interval change from baseline and plasma concentrations of LEE011 and/or any relevant metabolites|Day 14|Since the study was terminated, no efficacy data was obtained.|||||
14355|NCT01919229|Secondary|Change in ECG Morphology||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.|||||
14356|NCT01919229|Secondary|PK (Pharmacokinetics) Parameters, Including But Not Limited to, Cmax, Tmax, AUClast for LEE011 (and Any Relevant Metabolites) and Letrozole.||Days 1, 8, 14 and 15|Since the study was terminated, no efficacy data was obtained.|||||
14357|NCT01919229|Secondary|Change From Baseline in Expression of Retinoblastoma Protein (pRB)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.|||||
14358|NCT01919229|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.|||||
14359|NCT01919229|Secondary|Safety and Tolerability of the Combination|Occurrence, frequency and severity of adverse events (AEs), laboratory abnormalities|Up to 30 days after the last dose|Since the study was terminated, no efficacy data was obtained, but see Adverse Events (AE) section for all AEs collected.||Participants|||Number
14360|NCT01919229|Primary|Cell Cycle Response Rate Per Cell Proliferation Marker Ki67|Cell cycle response rate is defined by proportion of patients with natural logarithm of Ki-67 levels (expressed as percentage of baseline values) of less than 1 at the time of surgery. Since the trial was prematurely terminated, no statistical analysis was done.|Day 1, Day15|Since the study was terminated, no efficacy data was obtained.|||||
14361|NCT01918371|Secondary|Percentage of Phakic Patients With Cataract Surgery in the Study Eye|Phakic patients have intraocular lens implants.|4 Years|All phakic participants with data available.||percentage of participants|||Number
14362|NCT01918371|Secondary|Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
14363|NCT01918371|Secondary|Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
14364|NCT01918371|Secondary|Percentage of Participants With No Change in BCVA From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
14365|NCT01918371|Secondary|Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A gain of 1 or more lines read correctly from Baseline indicates an improvement of vision.|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
14366|NCT01918371|Secondary|Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A loss of 1 or more lines read correctly from Baseline indicates a worsening of vision.|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
14367|NCT01918371|Secondary|Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
14368|NCT01918371|Secondary|Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye||4 Years|All participants with data available.||percentage of participants|||Number
14372|NCT01918371|Secondary|Time Between Anti-VEGF Injections in the Study Eye|The mean time in months between anti-VEGF Injections.|4 Years|All participants with data available.||months||Standard Deviation|Mean
14373|NCT01918371|Secondary|Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.||months||Full Range|Median
14374|NCT01918371|Secondary|Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement in months in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.||months||Full Range|Median
14375|NCT01918371|Secondary|Time to Improvement in BCVA to 20/40 or Better in the Study Eye|Kaplan-Meier estimates of the time to Improvement in months in BCVA to 20/40 or Better. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly.|4 Years|All participants with available data.||months||Full Range|Median
14376|NCT01918371|Secondary|Time to Improvement of ≥3 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥3 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.||months||Full Range|Median
14377|NCT01918371|Secondary|Time to Improvement of ≥2 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥2 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.||months||Full Range|Median
14378|NCT01918371|Secondary|Change From Baseline in CRT by OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.||µm (microns)||Standard Deviation|Mean
14379|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.||percentage of participants|||Number
14380|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years|||percentage of participants|||Number
14381|NCT01918371|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A positive change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.||lines||Standard Deviation|Mean
14382|NCT01918371|Secondary|Mean BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|UP to 4 Years|All participants with data available.||lines||Standard Deviation|Mean
14383|NCT01918371|Secondary|Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.||percentage of participants|||Number
14384|NCT01918371|Secondary|Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.||percentage of participants|||Number
14385|NCT01918371|Secondary|Percentage of Participants With BCVA of 20/40 or Better in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly|Up to 4 Years|All participants with data available.||percentage of participants|||Number
14386|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 11 (Up to 4 Years)|All participants with data available up to time of Injection 11.||percentage of participants|||Number
14387|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 10 (Up to 4 Years)|All participants with data available up to time of Injection 10.||percentage of participants|||Number
14388|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 9 (Up to 4 Years)|All participants with data available up to time of Injection 9.||percentage of participants|||Number
14389|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 8 (Up to 4 Years)|All participants with data available up to time of Injection 8.||percentage of participants|||Number
14390|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 7 (Up to 4 Years)|All participants with data available up to time of Injection 7.||percentage of participants|||Number
14391|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 6 (Up to 4 Years)|All participants with data available up to time of Injection 6.||percentage of participants|||Number
14392|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 5 (Up to 4 Years)|All participants with data available up to time of Injection 5.||percentage of participants|||Number
14393|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 4 (Up to 4 Years)|All participants with data available up to time of Injection 4.||percentage of participants|||Number
14394|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 3 (Up to 4 Years)|All participants with data available up to time of Injection 3.||percentage of participants|||Number
14395|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 2 (Up to 4 Years)|All participants with data available up to time of Injection 2.||percentage of participants|||Number
14396|NCT01918332|Primary|LDL-C Percentage Changes at Week 8 From Baseline|LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline|8 weeks|FAS||percent change||95% Confidence Interval|Least Squares Mean
14397|NCT01918332|Primary|sitDBP Changes at Week 8 From Baseline|sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline|8 weeks|FAS||mmHg||95% Confidence Interval|Least Squares Mean
14418|NCT01917656|Secondary|Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.||Day -1 to day 29|Safety analysis set||Events/1000 years of patient exposure|||Number
14419|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set||percentage (%) of subjects|||Number
14398|NCT01918085|Primary|Peel Force|"The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees.~The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects."|1 hour|"Some of the measurements failed. i.e one subject was a wheel chair user and the peel force could not be measured on this person.~Only the measurements that did not fail were included in the analysis"||Newton||Standard Deviation|Mean
14399|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14400|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14401|NCT01918033|Secondary|Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator|The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14402|NCT01918033|Secondary|Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator|The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.|Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.||Participants|||Number
14403|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Assessed by the Investigator|The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14404|NCT01918033|Secondary|Change From Baseline in Nasal Finding Score Assessed by the Investigator|The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14405|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14406|NCT01918033|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14407|NCT01918033|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to Week 2|The ASaT population consisted of all participants who received at least one dose of study drug.||Participants|||Number
14408|NCT01918033|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to Week 4|The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
14409|NCT01918033|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Week 2|The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14410|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)|||minutes per day||Standard Deviation|Mean
14411|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)|||minutes per day||Standard Deviation|Mean
14412|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)|||steps per day||Standard Deviation|Mean
14413|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|"Defined as the time spent walking continuously for >10 minutes without breaking for more than a minute.~Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts."|Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)|||minutes per day||Standard Deviation|Mean
14414|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)|||minutes per day||Standard Deviation|Mean
14415|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)|||steps per day||Standard Deviation|Mean
14416|NCT01917773|Primary|Compared Colonic Motility Index From Fasting to Post Octreotide Infusion|"Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH).~Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes."|Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.|||mm Hg||95% Confidence Interval|Mean
14417|NCT01917656|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.|"A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events.~Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable"|Day -1 to day 29|Safety analysis set||Events/1000 years of patient exposure|||Number
14422|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)|The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
14423|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Fasting Plasma Glucose|The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||mmol/L||Standard Deviation|Mean
14424|NCT01917656|Secondary|Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)|The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||mmol/L||Standard Deviation|Mean
14425|NCT01917656|Secondary|Fructosamine at End of Ramadan|The fructosamine values at the end of Ramadan (visit 12) were presented|Day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||umol/L||Standard Deviation|Mean
14426|NCT01917656|Primary|Change in Fructosamine From Start of Ramadan to End of Ramadan|The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12).|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.||umol/L||Standard Deviation|Mean
14427|NCT01917526|Secondary|The Causes of Hypoxemia|Causes of hypoxemia in each participant in PACU will be recorded|In PACU (1 hr after anesthesia)|||causes of hypoxemia|||Number
14428|NCT01917526|Primary|Number of Participants With Hypoxemia in Both Groups|Hypoxemia is defined as oxygen saturation < 94%. We record number of participants with hypoxemia in both groups|In PACU (1 hr after anesthesia)|||number of participants|||Number
14429|NCT01917344|Secondary|Tremor as Determined Through Neurological Evaluation||During period of evaluation, approximately 8 hours||||||
14430|NCT01917344|Secondary|Diffusion Tensor Imaging (DTI) Findings Through MRI||During period of evaluation, approximately 8 hours||||||
14431|NCT01917344|Secondary|Volumetric MRI Findings||During period of evaluation, approximately 8 hours||||||
14432|NCT01917344|Secondary|Electroencephalogram (EEG) Findings||During period of evaluation, approximately 8 hours||||||
14433|NCT01917344|Secondary|Full Scale Intelligence Quotient (IQ)||During period of evaluation, approximately 8 hours||||||
14434|NCT01917344|Primary|Phenylalanine Level in the Brain as Determined by MR Spectroscopy and in Blood|Brain Phe levels (umol/L) using MRI correlated spectroscopy and Blood Phe levels (umol/L) obtained on the same day.|During period of evaluation, approximately 8 hours|||umol/L||Standard Deviation|Mean
14435|NCT01917214|Secondary|Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different durations of treatment with Sutent were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified treatment duration.||participants|||Number
14436|NCT01917214|Secondary|Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|"Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different Sutent doses were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. Here other refers to Sutent 12.5 mg."|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified Sutent treatment.||participants|||Number
14437|NCT01917214|Secondary|Time to Treatment Failure From Initiation of Sutent Therapy|Time to treatment failure was defined as the time from initiation of study treatment to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason. PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “N” (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
14438|NCT01917214|Secondary|Overall Survival (OS)|Overall survival was the duration from diagnosis of disease to death. Overall survival was compared for those who had received best supportive care to those who received Sutent as first-line therapy.|From diagnosis until death (up to 72 months)|Participants diagnosed with mRCC during time period between 1 January 2006 and 31 December 2011 and received Sutent or Best Supportive Care as a first-line therapy. Here, “N” (number of participants analyzed)=participants who were evaluable for this outcome measure. “n”=participants who were evaluable for this measure for each specified treatment.||months||95% Confidence Interval|Median
14525|NCT01914757|Secondary|Proportion of Nights With Awakening Due to Asthma|Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Proportion of nights||Standard Deviation|Mean
14439|NCT01917214|Secondary|Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) as per clinical and radiological documentation in clinical notes. CR was defined as complete resolution of all visible disease, whereas PR was defined as partial reduction in size of visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy.||percentage of participants|||Number
14440|NCT01917214|Primary|Progression-Free Survival (PFS) From Initiation of Sutent Therapy|PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study.|From initiation of treatment up to 72 months|Time to treatment failure (given in outcome measure 4) was used as a surrogate for PFS due to the lack of consistent regular restaging scans in clinical practice.|||||
14441|NCT01916980|Secondary|Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=Worst imaginable itch) at Baseline and subsequent clinic visits. Pruritus/itch VAS scores could range from 0 to 100, with a higher score indicating more severe pruritus/itching. The changes from Baseline in the VAS scores for pruritus/itch at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for participant-assessed pruritus/itch VAS score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14442|NCT01916980|Secondary|Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch. The Investigator assessed the degree of severity of pruritus/itch based on 5 grades (1=Remarkably improved to 5=Aggravated) at Baseline and subsequent clinic visits. The percentages of participants who were remarkably improved (Grade 1=Pruritus/itch disappeared) or moderately improved (Grade 2=Pruritus/itch was greatly improved) at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed Global Improvement.||Percentage of Participants|||Number
14443|NCT01916980|Secondary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime pruritus/itch scores at the Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14444|NCT01916980|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 12 weeks|The APaT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
14445|NCT01916980|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 14 weeks (Up to 2 weeks after last dose dose of study drug)|The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
14446|NCT01916980|Primary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14498|NCT01915823|Primary|Primary Efficacy|change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.|15 days of treatment|||units on a scale||Standard Deviation|Mean
14447|NCT01916967|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for DLQI||Score on a Scale||95% Confidence Interval|Least Squares Mean
14448|NCT01916967|Secondary|Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14449|NCT01916967|Secondary|Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2|Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14450|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14451|NCT01916967|Secondary|Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Participants|||Number
14452|NCT01916967|Secondary|Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14453|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14454|NCT01916967|Secondary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14455|NCT01916967|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 2 weeks|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.||Participants|||Number
14456|NCT01916967|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.||Participants|||Number
14457|NCT01916967|Primary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
14458|NCT01916928|Secondary|The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.||3-4 weeks after specimen processing||||||
14459|NCT01916928|Primary|The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.|Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise|During initial presentation for treatment|||percentage of participants|||Number
14460|NCT01916681|Secondary|Maternal Morbidity||Enrollment through discharge|||participants|||Number
14461|NCT01916681|Secondary|Chorioamnionitis||Enrollment through deischarge|||participants|||Number
14462|NCT01916681|Secondary|Regional Anesthesia||During delivery|||participants|||Number
14463|NCT01916681|Secondary|Time to Active Labor||Start of induction to active labor|||Hours||Inter-Quartile Range|Median
14464|NCT01916681|Secondary|Mode of Delivery|Cesarean Delivery|Start of induction to delivery|||participants|||Number
14465|NCT01916681|Primary|Severe RDS||enrollment through neonatal discharge|||participants|||Number
14466|NCT01916681|Primary|Length of Stay|Total maternal length of stay as defined as days from the day the induction began to the day of discharge|Days between admit to hospital and discharge|||Days||Inter-Quartile Range|Median
14467|NCT01916681|Primary|Time to Delivery|Amount of hours that pass between the start of the induction to delivery.|Hours between start of induction to delivery|||Hours||Inter-Quartile Range|Median
14468|NCT01916629|Primary|Percent Lesion Clearance||90 days|||Percent Clearance||Standard Deviation|Mean
14469|NCT01916590|Primary|Pain Scores Will be Collected for 48 Hours After ACL Reconstruction|Pain scores will be collected for 48 hours after ACL reconstruction with a patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block|48 hours after surgery|Because of the lack of enrollment no data was collected|||||
14470|NCT01916304|Secondary|Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone|Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.||percent change||Inter-Quartile Range|Median
14471|NCT01916304|Secondary|Absolute Serum Thyroid Stimulating Hormone Values|Blood samples were collected and samples were analyzed according to the local Quality System.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.||mIU/mL||Inter-Quartile Range|Mean
14472|NCT01916304|Secondary|Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L|Blood samples were collected and samples were analyzed according to the local Quality System.|Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.||percentage of participants|||Number
14473|NCT01916304|Secondary|Magnitude of the Change in Daily Dose Needed|Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.||percentage of participants|||Number
14474|NCT01916304|Primary|Percentage of Participants That Do Not Need a Change of Dose|Dose change was determined by physician according to their clinical judgement.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
14526|NCT01914757|Secondary|Home Lung Function Assessments Based on PEF|Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||L/min||Standard Deviation|Mean
14475|NCT01916226|Secondary|Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period|The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days.|Baseline through the entire treatment period (2 weeks)|Ocular Population. Change from Baseline was calculated as the 2-week average minus the Baseline value.n||Scores on a scale||Standard Error|Mean
14476|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period|The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that “instant.” The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Ocular Population||Scores on a scale||Standard Error|Mean
14477|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period|The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Ocular Population: all ITT participants with a Baseline rTOSS of 4 or greater||Scores on a scale||Standard Error|Mean
14478|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period|The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that “instant.” The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days.|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2. Change from Baseline was calculated as the 2-week average minus the Baseline value.||Scores on a scale||Standard Error|Mean
14479|NCT01916226|Secondary|Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.|The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value.|Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal|ITT Population||Scores on a scale||Standard Error|Mean
14480|NCT01916226|Secondary|Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period|Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.||Scores on a scale||Standard Error|Mean
15965|NCT01872715|Secondary|Patient Satisfaction Question|The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.|Week 2, 6, and 12|||participants|||Number
14481|NCT01916226|Primary|Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period|The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.||Scores on a scale||Standard Error|Mean
14482|NCT01916109|Primary|Pathologic Complete Response Rate (<pT0)|The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|1 year|||participants|||Number
14483|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using the Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each sign (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Maintenance Phase and Follow-up Phase and is calculated as the score at the end of the Maintenance and Follow-up Phase minus the Baseline score. Baseline is defined as VAS score for each sign obtained at Visit 4 (end of Acute Phase). Summation of VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at the Maintenance and Follow-up phase of study. The missing value was imputed using last-observation-carry-forward (LOCF) method.|Baseline, Week 20 and Week 32|ITT Population||Scores on a scale||Standard Deviation|Mean
14484|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each signs (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Acute Phase (Visit 4 [Week 0 or treatment success, depend on which time point comes first) ±2day]) and is calculated as the score at Visit 4 minus the Baseline score. Baseline is defined as the VAS score for each sign obtained before the first dose of study drug in the Acute Phase of the study (Visit 2). Summation of the VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at Visit 4 of the Acute Phase of the study.|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population||Scores on a scale||Standard Deviation|Mean
14485|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: It leaves my skin feeling soft and smooth; Q 2: There is nothing left on my skin; Q 3: Does not feel greasy; Q 4: Disappears into my skin quickly after I put it on; Q 5: Easy to apply; Q 6: Fragrance-free; Q 7: Spreadability; Q 8: Lack of stickiness. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree, 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population||Participants|||Number
14486|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: This product is easier to use than other skin emollients; Q 2: When I apply this product I am able to start my daily activities quicker than with other skin emollients; Q 3: This product leaves my skin feeling softer than other skin emollients; Q 4: I am able to apply this product to larger body surface areas than other skin emollients; Q 5: This product disappears into my skin quicker than when I apply other skin emollients. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree, 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|Enrolled Population||Participants|||Number
14487|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire|Participants from each group completed the post-study questionnaire to rate the skin emollients (gel, lotion, cream, ointment, solution and foam) used in the past based on their experience. Participants rated skin emollients on a 5-point scale (5= “liked the best”, 4= “second best”, 3= “third best”, 2= “fourth best, 1= “liked the least”, N/A=Does not apply to me).|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population||Participants|||Number
14499|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|PP Population||Participants|||Number
14488|NCT01915914|Secondary|Change From Baseline in QoL at the End of the Follow-up Phase|Infant's IDQOL and Children's CDLQI were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with AD, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in QoL score is based on each questionnaire at the end of the Follow-up Phase and is calculated as the score at the end of the Follow-up Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 32|ITT Population||Scores on a scale||Standard Deviation|Mean
14489|NCT01915914|Secondary|Change From Baseline in Quality of Life (QoL) at the End of the Maintenance Phase|Infant's Dermatitis Quality of Life Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with atopic dermatitis, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in the QoL score is based on each questionnaire at the end of the Maintenance Phase and is calculated as the score at the end of the Maintenance Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 20|ITT Population||Scores on a scale||Standard Deviation|Mean
14490|NCT01915914|Secondary|Number of Participants With “Treatment Success” During the Acute Phase|"The number of participants with treatment success” during the Acute Phase is presented. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to Baseline in the Acute Phase of the study."|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population: all participants who were enrolled into the Acute Phase of the study.||Participants|||Number
14491|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Follow-up Phase (Week 32)|The number of participants with AD recurrent/relapse at the end of the Follow-up Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 20 to Week 32|ITT Population||Participants|||Number
14492|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Maintenance Phase (Week 20)|The number of participants with AD recurrent/relapse at the end of Maintenance Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 0 (or treatment success, if earlier) to Week 20|ITT Population||Participants|||Number
14493|NCT01915914|Secondary|Median Time to the First Relapse of AD During the Maintenance Phase and Follow-up Phase|Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase is defined as the number of days from start of the FP treatment until AD relapse during the Maintenance Phase and Follow-up Phase. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during the Acute Phase.|From the start of treatment up to Week 32 during the Maintenance Phase and Follow-up Phase|ITT Population. Only participants avilable at the specified time point were analyzed.||Days||95% Confidence Interval|Median
14494|NCT01915914|Primary|Time to the First Relapse of AD During the Maintenance Phase|Time to the first relapse of AD is defined as the number of days from start of the FP treatment in Maintenance Phase until AD relapse. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during Acute Phase. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From the start of treatment up to Week 20 during the Maintenance Phase|ITT Population: all participants who were randomized into the Maintenance Phase. Only participants available at the specified time point were analyzed.||Days||95% Confidence Interval|Median
14495|NCT01915849|Primary|Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose|Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.|Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)|The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||(umol/kg FFM/min)*hr||Standard Deviation|Mean
14496|NCT01915823|Other Pre-specified|Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)|Change from baseline to Visit 4 in the ITT ( intent to treat) Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects equal to or greater than 6 years old and less than12 years old compared to placebo.Scored on a 0 to 7 scale with 0 being not troubled at all and 7 being extremely troublesome. The higher the difference the better the result.|day 1 to day 15 of treatment|||units on a scale||Standard Deviation|Mean
14497|NCT01915823|Secondary|Safety|"Subject-reported adverse experiences (incidence, type, and severity of adverse events)~Nasal Examinations~Vital signs assessments"|entire length of study (day 1 to day 22)|||occurance|||Number
14500|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|ITT Population||Participants|||Number
14501|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population||Percent change in lesions||Standard Error|Least Squares Mean
14502|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population||Percent change in lesions||Standard Error|Least Squares Mean
14503|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population||Lesions||Standard Error|Least Squares Mean
14504|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population||Lesions||Standard Error|Least Squares Mean
14505|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .|Baseline (Week 0) and Week 12|PP Population||Participants|||Number
14506|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population||Participants|||Number
14507|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.||Change in lesion count||Standard Error|Least Squares Mean
14508|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.||Change in lesion count||Standard Error|Least Squares Mean
18969|NCT01797029|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 7 to 9 months post-vaccination|||percentage of participants|||Number
14509|NCT01915108|Primary|Number of Patients With Adverse Events Following LMA Removal|All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.|from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.|||participants|||Number
14510|NCT01914926|Primary|Percent of Patients Reaching Target HR<100bpm Within 30 Minutes|Percent of patient who reached a HR<100bpm within 30 minutes from baseline.|30 minutes|||percentage of participants|||Number
14511|NCT01914757|Secondary|Patient and Clinician Assessment of Response to Treatment|CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
14512|NCT01914757|Secondary|Number of Participants That Utilized Health Care Resources||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
14513|NCT01914757|Secondary|Mean Productivity Loss Due to Asthma in Classroom|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who took classes||percent of productivity loss||Standard Deviation|Mean
14514|NCT01914757|Secondary|Mean Work Productivity Loss Due to Asthma|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who were employed||Percent of productivity loss||Standard Deviation|Mean
14515|NCT01914757|Secondary|Change From Baseline to Week 56 in EQ-5D-5L VAS|EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
14516|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in AQLQ(S)+12|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
14517|NCT01914757|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment in days|Immediately following the first administration of study drug through Study Week 56|Safety analysis set||Days||Standard Deviation|Mean
14518|NCT01914757|Secondary|Immunogenicity of Benralizumab|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.|Pre-treatment until end of follow-up|Safety analysis set||Participants|||Number
14519|NCT01914757|Secondary|Pharmacokinetics of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
14520|NCT01914757|Secondary|Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations|Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Events/year||95% Confidence Interval|Least Squares Mean
14521|NCT01914757|Secondary|Time to First Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
14522|NCT01914757|Secondary|Number of Patients With >=1 Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Participants|||Number
14523|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
14524|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
14527|NCT01914757|Secondary|Change in Asthma Rescue Medication Use|Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Puffs per day||Standard Deviation|Mean
14528|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
14529|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Scores on a scale||Standard Deviation|Mean
14530|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS||Liter||Standard Deviation|Mean
14531|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS||Liter||Standard Deviation|Mean
14532|NCT01914757|Secondary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS.||Events/year||95% Confidence Interval|Least Squares Mean
14533|NCT01914757|Primary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS.||Events/year||95% Confidence Interval|Least Squares Mean
14534|NCT01914666|Secondary|Number of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Week 53|All the enrolled participants who received at least 1 dose of study drug.||participants|||Number
14535|NCT01914666|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline, Week 53|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.LOCF was used.||participants|||Number
14536|NCT01914666|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50|BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Deviation|Mean
14537|NCT01914666|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Deviation|Mean
14538|NCT01914666|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50|SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.||units on a scale||Standard Deviation|Mean
14568|NCT01912768|Primary|Number of Unscheduled Lens Replacements by Reason|A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.||lenses|||Number
14539|NCT01914666|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50|RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.||units on a scale||Standard Deviation|Mean
14540|NCT01914666|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.||units on a scale||Standard Deviation|Mean
14541|NCT01914666|Secondary|Patient Global Impression of Improvement (PGI-Improvement) to Week 50|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Deviation|Mean
14542|NCT01914666|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50|A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 50|(FAS): All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
14543|NCT01914666|Primary|Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE’s|A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Week 53|All the enrolled participants who received at least 1 dose of study drug.||participants|||Number
14544|NCT01914003|Primary|Prevalence of CSID Genetic Variants|Prevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation.|1 year|||Participants|||Number
14545|NCT01913795|Other Pre-specified|Asthma Control||12 months||||||
14546|NCT01913795|Other Pre-specified|Rescue Medication||12 months||||||
14547|NCT01913795|Other Pre-specified|FeNO||12 months||||||
14548|NCT01913795|Secondary|Lung Function|peak expiratory flow (PEF)|measured at baseline and months 6 and 12|||Liters/second||Standard Error|Mean
14549|NCT01913795|Primary|Asthma Symptoms|number of days of wheezing/cough|over a two week period at Baseline and Months 3, 6, 9 and 12|||Days||Full Range|Mean
14550|NCT01913041|Primary|The Incidence of Perioperative Hypothermia|Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature <36℃) accounts for the total amount of participants.|Perioperative period started from anesthesia induction to surgery ended|Actually 869 patients are enrolled, among which 39 patients were eliminated for the reasons operation cancelled temporarily or violate the eligible criteria, so 830 participants for analysis was determined to be analyzed per protocol in the end.||Percentage of hypothermia participants|||Number
14551|NCT01912781|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.||percentage of lens area||Standard Deviation|Mean
14552|NCT01912781|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.||percentage of lens area||Standard Deviation|Mean
14553|NCT01912781|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
14554|NCT01912781|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
14555|NCT01912781|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
14556|NCT01912781|Primary|Number of Unscheduled Lens Replacements by Reason|No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.||lenses|||Number
14557|NCT01912781|Primary|Average Lens Wear Time|Subject recorded a response to the question, “Averaging over the last 3 days, how many hours per day did you wear your contact lenses?” Lens wear time was measured in hours.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||Hours||Standard Deviation|Mean
14558|NCT01912781|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
14559|NCT01912781|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 90/Early Exit|This analysis population includes all randomized subjects.||micrograms per lens||Standard Deviation|Mean
14560|NCT01912781|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.||percentage of subjects|||Number
14561|NCT01912781|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.||percentage of subjects|||Number
14562|NCT01912781|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.||percentage of subjects|||Number
14563|NCT01912768|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."||percentage of lens area||Standard Deviation|Mean
14564|NCT01912768|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."||percentage of lens area||Standard Deviation|Mean
14565|NCT01912768|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
14566|NCT01912768|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
14567|NCT01912768|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
14569|NCT01912768|Primary|Average Lens Wear Time|"Subject recorded a response to the question, Averaging over the last 3 days, how many hours per day did you wear your contact lenses? Lens wear time was measured in hours."|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||Hours||Standard Deviation|Mean
14570|NCT01912768|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
14571|NCT01912768|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 30/Early Exit|This analysis population includes all subjects with data at visit.||micrograms per lens||Standard Deviation|Mean
14572|NCT01912768|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."||percentage of subjects|||Number
14573|NCT01912768|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."||percentage of subjects|||Number
14574|NCT01912768|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."||percentage of subjects|||Number
14575|NCT01912599|Primary|Systolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|||mmHg||Standard Deviation|Mean
14576|NCT01912599|Primary|Diastolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|||mmHg||Standard Deviation|Mean
14577|NCT01912599|Primary|Mean Perfusion Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|||mmHg||Standard Deviation|Mean
14578|NCT01912599|Primary|Intraocular Pressure|The IOP provided is the average of all 144 measurements taken during the 24 hour period.|24 Hours|||mEqv.||Standard Deviation|Mean
14579|NCT01912599|Primary|Arterial Pressure|The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|"Data for two glaucoma patients were excluded for analysis because~In one patient the IOP recorder malfunctioned just two hours after set up, so data were not available for the entire 24 hours~In the other patient, the wireless sensor was disconnected from the recorder in the middle if the night so data could not be recorded."||mmHg||Standard Deviation|Mean
14580|NCT01912495|Secondary|Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.|only serious adverse events are recorded in this secondary endpoint|72 weeks|57 patients started treatment and were at risk||participants|||Number
14581|NCT01912495|Secondary|Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.||72 weeks|data were not collected during this study|||||
14582|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.|The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.|12 weeks|5 patients were treated within 12 weeks after calculated transmission date. All other patients were treated between 12 and 26 weeks after calculated transmission date.||participants|||Number
14583|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.|The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment|12 weeks|All patients having a rapid viral response at week 4 had a sustained viral response at 12(SVR12) weeks after treatment.||participants|||Number
14584|NCT01912495|Secondary|SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).|The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy|12 weeks|Total intention to treat population||participants|||Number
16012|NCT01871532|Secondary|Change From Baseline in Anti-Mullerian Hormone (AMH) Levels at Week 4||Baseline, Week 4|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
14585|NCT01912495|Primary|Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population.|The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.|12 weeks|41 patients had a RVR4||participants|||Number
14586|NCT01912404|Primary|Survival||28 days|The study was prematurely stopped due to emerging data from another study showing ~10 to 12-fold higher exposures in patients with severe hepatic impairment compared to those with normal liver function. Since subjects with alcoholic hepatitis would likely have severe hepatic impairment, the study was stopped and survival data was not collected.|||||
14587|NCT01912352|Secondary|Clinical Global Impression-Improvement Scale at 8 Weeks|"Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: “Compared to the patient's condition at baseline [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.~Clinical Global Impression-Improvement was measured at 8 weeks."|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
14588|NCT01912352|Primary|Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks|"Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms).~Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks."|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
14589|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.||participants|||Number
14590|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.||participants|||Number
14591|NCT01912222|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.||participants|||Number
14592|NCT01912222|Primary|Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.||hours||Full Range|Median
14593|NCT01912222|Primary|Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
14594|NCT01912222|Primary|Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
14595|NCT01911845|Secondary|Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||ng/mL||Standard Deviation|Mean
14596|NCT01911845|Secondary|Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||hours||Standard Deviation|Mean
14623|NCT01911403|Secondary|Number of Patients With Any Complications|"Number of patients with any complications since the puncture closure until 2 weeks ± 1 week.~The complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion."|At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)|||participants|||Number
14597|NCT01911845|Secondary|Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||ng/mL||Standard Deviation|Mean
14598|NCT01911845|Secondary|Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng*hr/mL)] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling||ng*hr/mL||Standard Deviation|Mean
14599|NCT01911845|Secondary|Percentage of Participants With Virologic Relapse Post-treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days.|From the end of treatment through 12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.||Percentage of participants|||Number
14600|NCT01911845|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks [≥ 36 days] of treatment.|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All enrolled participants who received at least 1 dose of study drug.||Percentage of participants|||Number
14601|NCT01911845|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All enrolled participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
14602|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FASEX (OC)||mmHg||Standard Error|Mean
14603|NCT01911780|Secondary|Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS in the extension period (FASEX OC) was defined as a collection of patients i) included in the FAS; ii) taking at least 1 dose of T80/A5/H12.5 mg in the extension period; and iii) taking measurements of seated DBP at reference baseline and at 1 or more time points in the extension period.||mmHg||Standard Error|Mean
14604|NCT01911780|Secondary|The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.|"The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS||Participants|||Number
14605|NCT01911780|Secondary|The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.|The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|Double-blind and 8 weeks|FAS||Participants||95% Confidence Interval|Number
14606|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|FAS||mmHg||Standard Error|Mean
14624|NCT01911403|Secondary|Number of Patients With Mobilization Time Between 4-48 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge|||participants|||Number
14625|NCT01911403|Primary|Number of Patients With Mobilization Time Between 0-4 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge|||participants|||Number
14607|NCT01911780|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|Full analysis set (FAS) was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period||mmHg||Standard Error|Mean
14608|NCT01911689|Secondary|The Relationship Between the T2* Value and the Severity of AP According to Apache II|In clinical practice, the physician usually used the APACHE II to evaluate the severity of acute pancreatitis. AP was graded as mild (0-7 points) and severe AP (≥8 points) according to the APACHE II scoring system.|1 year|Indengpent T test||ms||Standard Deviation|Mean
14609|NCT01911689|Secondary|The T2* Value in Different Severity of AP According to MRSI|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .|1 year|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .||ms||Standard Deviation|Mean
14610|NCT01911689|Secondary|The Difference of T2* Value Between the Edematous AP and Necrotizing AP|Compare the difference of the T2* value between the edematous AP group and necrotizing AP group|1 year|compare the difference of T2* value between the edematous AP and necrotizing AP||ms||Standard Deviation|Mean
14611|NCT01911689|Primary|The T2* Values in the Diagnosis of AP|Compare the difference of the T2* value between the AP group and the control group.|1 year|compare T2* value between the AP group and the control group using independent sample t test||ms||Standard Deviation|Mean
14612|NCT01911442|Secondary|Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.||6 Weeks|ITT||percentage of subjects|||Number
14613|NCT01911442|Secondary|Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6||6 Weeks|ITT - the current data presented is at week 6.||percentage of subjects|||Number
14614|NCT01911442|Secondary|Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)|CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain.|6 Weeks|ITT||units on a scale||Standard Error|Least Squares Mean
14615|NCT01911442|Secondary|Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)|CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score.|6 Weeks|ITT||units on a scale||Standard Error|Least Squares Mean
14616|NCT01911442|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6|The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|ITT||units on a scale||Standard Error|Least Squares Mean
14617|NCT01911442|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6|The Clinical Global Impression – Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat population. 49 in the placebo arm is correct. One subject in the placebo group did not receive the study medication, and therefore that subject was removed from the ITT population. A total of 50 subjects were randomized and 49 subjects were included in the placebo group of the ITT population.||units on a scale||Standard Error|Least Squares Mean
14618|NCT01911442|Primary|Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6|The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat (ITT) population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.||units on a scale||Standard Error|Least Squares Mean
14619|NCT01911403|Secondary|Percentage of Patients With Angio-Seal™ Deployment Success|"According the physician criteria, it will be YES If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture."|At puncture closure|Only patients in the Angio-Seal arm is analyzed||percentage of patients|||Number
14620|NCT01911403|Secondary|Time to Discharge From Interventional Radiology Department|Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.|At discharge|||hours||Standard Deviation|Mean
14621|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 4-60 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure|||participants|||Number
14622|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 0-4 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure|||participants|||Number
14626|NCT01911351|Other Pre-specified|Percentage of Providers Who Rated the Procedure as Being Successful|Survey collection of rating of success of the procedure by one provider. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. The first two categories were combined.|measured at the end of each procedure, approximately 10 minutes after the completion of the procedure|||percentage of participants|||Number
14627|NCT01911351|Other Pre-specified|Percentage of Parents Who Reported That Their Child Was Comfortable During the Procedure|"A parental survey was collected post-procedure regarding the overall comfort of the child during the procedure. Other questions included whether the procedure was successfully completed, if the procedure went better than expected, was the parent pleased with the medications used and whether the child tolerated the procedure. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. We chose the question that asked whether the child was comfortable during the procedure as it was most relevant. The categories Strongly Agree and Agree were combined in both groups."|measured at the end of each procedure, approximately 10 minutes after the procedure is completed|In the Standard Management arm, 38/39 parents completed the survey||percentage of participants|||Number
14628|NCT01911351|Other Pre-specified|Length of the Procedure|Another outcome measure is to compare the change in length of the procedure with or without nitrous oxide intervention.|measure time duration of each procedure, average 5-15 minutes|||minutes||Inter-Quartile Range|Median
14629|NCT01911351|Secondary|M-YPAS Anxiety Scale|Secondary outcome will be the Modified YALE Preoperative Anxiety Scale, measured pre-procedure, and intra-procedure. This is a validated scale measuring anxiety by assessment of Activity, Vocalization, Emotional Expressivity, State of Arousal and Use of Parents. All categories have a maximum score of 4 except for Vocalization with a maximum score of 6. The scores within each category are totaled and a total anxiety score is reported ranging from 5 (no anxiety) to 22 (highest level of anxiety).|measured pre-procedure at time provider explains procedure to the patient, and during procedure at peak pain time approximately 2-5 minutes into the procedure|||units on a scale||Inter-Quartile Range|Median
14630|NCT01911351|Primary|FLACC Pain Scale|The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.|peak pain during procedure approximately 2-5 minutes into the procedure|||units on a scale||Inter-Quartile Range|Median
14631|NCT01911273|Secondary|Observed Serum Concentration of Circulating Protein||Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.||mcg/mL|||Number
14632|NCT01911273|Secondary|Ratio to Baseline of Serum Circulating Protein Concentration|Protein involved TGFB1, VEGF-A, VEGF-C, PIGF, Endoglin, BMP-9, VEGFR1, VEGFR2, VEGFr3, Ang-2, VEGF-D, CD54, CD106, and CCL2. Tumor molecular characteristics including but not limited to transcriptomic (ribonucleic acid) signatures of efficacy.|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.||Percentage|||Number
14633|NCT01911273|Secondary|Presence of Sensitivity Signature|Tumor molecular characteristics including but not limited to transcriptomic (RNA) signatures of sensitivity|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.|||||
14634|NCT01911273|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)||Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose)|The immunogenicity assessment consisted of all participants who had at least 1 sample on at least 1 day of immunogenicity assessment.||Participants|||Number
14635|NCT01911273|Secondary|Trough Serum Concentration of PF-03446962 (Ctrough)||0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8|The PK concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.||mcg/mL||Standard Error|Geometric Mean
14636|NCT01911273|Secondary|Maximum Serum Concentration (Cmax)||1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8|The pharmacokinetic (PK) concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.||microgram per milliliter (mcg/mL)||Standard Error|Geometric Mean
14637|NCT01911273|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep)|Patient reported outcomes (PROs) were assessed using the FACT-Hep. The FACT-Hep included the FACT-general (FACT-G) and a hepatobiliary module, it consisted of the 27-item FACT-G, which assessed generic health-related quality of life (HRQoL) concerns, and the 18-item hepatobiliary subscale (HS), which assessed disease-specific issues. The questionnaire used a 5 point Likert scale from ‘0’ “not at all” to ‘4’ “very much” regarding how much each item was present in the last 7 days; lower score indicated severer symptom. Eight of the items (lack of energy, pain, weight loss, back pain, fatigue, stomach pain/discomfort, nausea, and jaundice) made up the Fact Hepatobiliary Symptom Index (FHSI 8) were considered to be symptoms specific to hepatobiliary cancer.|Screening, Cycle 1 Day1,8; Cycle >=2 Day1; End of treatment, survival follow-up up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Units on scale||Standard Deviation|Mean
14638|NCT01911273|Secondary|Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks|DCR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease (SD) >=16 weeks according to RECIST, relative to all randomized participants. CR was defined as disappearance of all target lesions. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|FAS included all randomized participants regardless of what treatment, if any, was received.||Percentage of Participants||95% Confidence Interval|Number
16013|NCT01871532|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered Per Cycle||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
14639|NCT01911273|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included >1 date, the first date was to be used. DR (in months) was calculated as the end date for DR minus date of first CR or PR that was subsequently confirmed plus 1 divided by 30.4. CR was defined as disappearance of all target lesions and non-target, if any. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Subgroup of participants with objective response. Since objective response was not assessed in any of the participants, ideally the number of participants analyzed field should be 0 and the reason was insufficient data available to conduct adequate analysis due to premature termination of the study.|||||
14640|NCT01911273|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1, relative to all randomized participants. CR were those that persisted on repeat imaging study more than or equal to (>=) 4 weeks after initial documentation of response. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were to be counted as non-responders in the assessment of ORR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR, was to be assigned a best response of CR.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Percentage of Participants|||Number
14641|NCT01911273|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included >1 date, the first date was to be used. PFS (in months) was calculated as first event date minus first randomization date plus 1 divided by 30.4.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
14642|NCT01911273|Primary|Overall Survival (OS)|OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death.|From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Full analysis set (FAS) included all randomized participants regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
14643|NCT01911273|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from first randomization to date of first documentation of objective tumor progression. If tumor progression data included more than (>) 1 date, the first date was to be used. TTP (in months) was calculated as first event date or last known progression-free date minus the first randomization date plus 1 divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
14644|NCT01911260|Primary|Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period.|"Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ < -1,5 Z-score), and Normal Height (HAZ between -1,0 and ±1,0 Z-score), and were randomly assigned to compose two exposed groups to receive a supplement of 30mg of zinc amino acid chelate, and two control groups to receive placebo individually once a week, during 12 weeks. Children's heights were measured at the End of Supplementation period and again after 12 weeks (Follow-up period). In combination with sex and age we transformed stature to Height-for-Age, expressed in Z-score, which was calculated as a number of standard deviations or Z-scores below or above the reference mean or median value, according to the formula below:~Z-score = (observed value - median value of the reference population) / standard deviation value of reference population.~We analyzed and discussed the change in HAZ (HAZ at the End of Follow-up period - HAZ at End of Supplementation)."|Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.|||Z-Score||Standard Deviation|Mean
14645|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.||Number of subjects|||Number
14646|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.||Number of subjects|||Number
14647|NCT01911221|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)|The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported.|Day 1 through Day 7 postvaccination.|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
14664|NCT01910636|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
14648|NCT01911221|Primary|Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.||Percentage of Subjects||95% Confidence Interval|Number
14649|NCT01911221|Primary|Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.||Ratio||95% Confidence Interval|Geometric Mean
14650|NCT01911221|Primary|Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule|The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination.|Day 1 and Day 91|Analysis was done on Full Analysis Set.||U/mL||95% Confidence Interval|Geometric Mean
14651|NCT01911221|Primary|Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day 91|Analysis was done on Full Analysis Set.||Percentage of subjects||95% Confidence Interval|Number
14652|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.||Percentage of Subjects||95% Confidence Interval|Number
14653|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.||Percentages of subjects||95% Confidence Interval|Number
14654|NCT01911221|Primary|Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.|Day1 and Day 91|The analysis was done on the Full Analysis Set.||ratio||95% Confidence Interval|Geometric Mean
14655|NCT01911221|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.|Day1 and Day 91|Analysis was done on Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
14656|NCT01910831|Secondary|Investigator Global Assessment (IGA)|"To determine efficacy with respect to the IGA of improving the appearance of “bruising” and reducing the appearance of photoaging of the forearms and hands:~IGA:~0=No improvement~<25% improvement~25% to 50% improvement~51% to 75% improvement~>75% improvement"|12 Weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.||units on a scale||Standard Deviation|Mean
14657|NCT01910831|Primary|Reduction of Bruising|To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in improving the appearance of bruising and reducing the appearance of photoaging of the forearms and hands in mature skin.|12 weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.||cm squared||Standard Deviation|Mean
14658|NCT01910688|Secondary|Adverse Events|Adverse event profile: Relationship to study device : Definite, Probable, Possible|12 months|||number of events|||Number
14659|NCT01910688|Secondary|Patient Tolerability|Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.|12 months|||number of events|||Number
14660|NCT01910688|Secondary|Technical Feasibility: Percentage of Participants Who Completed RFA Treatment|Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.|Day 0, month 4, month 8|At 0 month, 25 received 1st RFA treatment; at 4 month, 22 received 2nd RFA treatment; at 8 month, 18 received RFA Treatment||percentage of participants|||Number
14661|NCT01910688|Primary|Excess Body Weight Loss After RFA Treatment|EBWL 12 months after enrollment|12 months|||percentage of EBWL||Standard Deviation|Mean
14662|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
14663|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.|Up to 12 weeks|Full Analysis Set||percentage of participants|||Number
14665|NCT01910636|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
14666|NCT01910636|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, and had chronic genotype 2 HCV infection.||percentage of participants|||Number
14667|NCT01910441|Primary|Mean Amplitude of Glycemic Excursions (MAGE)||16 weeks|The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed.|||||
14668|NCT01910402|Secondary|Number of Participants With Treatment Emergent Resistances|Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.|Up to week 48|On-treatment Genotypic Resistance Population||Participants|||Number
14669|NCT01910402|Secondary|Number of Participants With Post-Baseline HIV-1 Disease Progression|Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Up to week 48|ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.||Participants|||Number
14670|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups|Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Week 48|ITT-E Population||Percentage of participants|||Number
14671|NCT01910402|Secondary|Assessment of HIVTSQs Total Score at Indicated Timepoints.|The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Week 4, 12, 24, 48|ITT-E Population||Score on a scale||Standard Deviation|Mean
14672|NCT01910402|Secondary|Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS|The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline and Week 48|ITT-E Population||Score on a scale||Standard Deviation|Mean
14673|NCT01910402|Secondary|Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.|Baseline, Weeks 24, 48|Safety Population.||Ratio||95% Confidence Interval|Number
14674|NCT01910402|Secondary|Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Weeks 24, 48|Safety Population||Nanomoles per liter||Standard Deviation|Mean
14675|NCT01910402|Secondary|Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population||Nanograms per liter||Standard Deviation|Mean
14676|NCT01910402|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population||Micrograms per liter||Standard Deviation|Mean
14677|NCT01910402|Secondary|Number of Participants Who Withdrew From Treatment Due to AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
14678|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Hematology Toxicities|Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
14679|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Chemistry Toxicities|Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
14680|NCT01910402|Secondary|Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.|From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)|Safety Population||Participants|||Number
14681|NCT01910402|Secondary|Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table.|Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population||Participants|||Number
14682|NCT01910402|Secondary|Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points|Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline, Week 24, Week 48|Safety Population||milligrams per millimole||Standard Deviation|Mean
14683|NCT01910402|Secondary|Change From Baseline in TC/HDL Ratio at Week 48|Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.||Ratio||Standard Error|Least Squares Mean
14726|NCT01910181|Primary|AUC From 0 to 168 Hours of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 168 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
14684|NCT01910402|Secondary|Change From Baseline in Triglycerides at Week 48|Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.||Millimoles per liter||Standard Error|Least Squares Mean
14685|NCT01910402|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Femtoliter||Standard Deviation|Mean
14686|NCT01910402|Secondary|Change From Baseline in Hematocrit Count at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Fraction of 1||Standard Deviation|Mean
14687|NCT01910402|Secondary|Change From Baseline in Erythrocytes at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||10^12 per liter||Standard Deviation|Mean
14688|NCT01910402|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||10^9 cells per liter||Standard Deviation|Mean
14689|NCT01910402|Secondary|Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Ratio||Standard Deviation|Mean
14690|NCT01910402|Secondary|Change From Baseline in Lipase at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Units per liter||Standard Deviation|Mean
14691|NCT01910402|Secondary|Change From Baseline in Creatinine Clearance at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Milliliter per minute||Standard Deviation|Mean
14692|NCT01910402|Secondary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||International units per liter||Standard Deviation|Mean
14693|NCT01910402|Secondary|Change From Baseline in Albumin at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Grams per liter||Standard Deviation|Mean
14694|NCT01910402|Secondary|Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population||Micromoles per liter||Standard Deviation|Mean
14695|NCT01910402|Secondary|Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|"Safety Population. A value of 99999 indicates where no data is available or not able to determine the value."||Millimoles per liter||Standard Deviation|Mean
14696|NCT01910402|Secondary|Change From Baseline in CD4+ Cell Count at Indicated Timepoints|Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population||Cells per millimeter cube||Standard Deviation|Mean
14697|NCT01910402|Secondary|Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points|Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population||Log10 copies/mL||Standard Deviation|Mean
14698|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time|Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value.|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population||Percentage of participants|||Number
14699|NCT01910402|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48|Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication.|Week 48|ITT-E Population||Percentage of participants|||Number
14700|NCT01910389|Secondary|Trend in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
14701|NCT01910389|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
14702|NCT01910389|Secondary|Trend in 6 Minute Walk Distance From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
14703|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.|||||
14704|NCT01910389|Secondary|Change in MLHFQ Score From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.|||||
14705|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.|||||
14706|NCT01910389|Secondary|Frequency of HF Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
14707|NCT01910389|Secondary|Frequency of CV Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
14708|NCT01910389|Secondary|Composite Outcome of All-cause Mortality or CV Hospitalization (Myocardial Infarction, Acute Coronary Syndrome, Stroke, Arrhythmia, or Heart Failure)||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
14709|NCT01910389|Secondary|All-cause Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
14710|NCT01910389|Secondary|Heart Failure Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
14711|NCT01910389|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
14712|NCT01910389|Primary|Composite Outcome of Cardiovascular (CV) Mortality or Heart Failure (HF) Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.|||||
14713|NCT01910181|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||months||95% Confidence Interval|Median
14714|NCT01910181|Secondary|Percentage of Participants Who Died|The percentage of participants who died during the study was reported.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||percentage of participants|||Number
14715|NCT01910181|Secondary|Progression-Free Survival (PFS)|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). PFS was defined as the time from treatment start to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||months||95% Confidence Interval|Median
14716|NCT01910181|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants with death or disease progression during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||percentage of participants|||Number
14717|NCT01910181|Secondary|Duration of Response According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). Duration of response was defined as the time from initial response of CR or PR to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% confidence interval (CI) was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.||months||95% Confidence Interval|Median
14718|NCT01910181|Secondary|Percentage of Participants With Disease Progression or Death Among Participants With a Previous Assessment of CR or PR According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants who died or progressed after CR or PR was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.||percentage of participants|||Number
14719|NCT01910181|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease from Baseline in sum diameter of target lesions. The percentage of participants with a best overall response of CR or PR during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.||percentage of participants||95% Confidence Interval|Number
14720|NCT01910181|Primary|Terminal Elimination Rate Constant (Kel) of RO5185426 on Day 21|Plasma PK samples were obtained from each participant and the kel was estimated. The value was averaged among all participants and expressed in inverse hours (h^-1).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||hours^-1||Standard Deviation|Mean
14721|NCT01910181|Primary|Accumulation Ratio of RO5185426 AUC From 0 to 8 Hours Between Day 21 and Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The AUC on Day 21 was divided by the AUC for Day 1. The resulting value was averaged among all participants and expressed as the accumulation ratio.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Days 1 and 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||accumulation ratio||Standard Deviation|Mean
14722|NCT01910181|Primary|Ctrough of RO5185426 on Day 21|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
14723|NCT01910181|Primary|Ctrough of RO5185426 on Day 19|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 19|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
14724|NCT01910181|Primary|Trough Plasma Concentration (Ctrough) of RO5185426 on Day 15|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 15|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
14725|NCT01910181|Primary|Elimination Half-Life (t1/2) of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of t1/2, defined as the time elapsed for plasma concentrations to drop by half. The value was averaged among all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||hours||Standard Deviation|Mean
14727|NCT01910181|Primary|Tmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||hours||Full Range|Median
14728|NCT01910181|Primary|Time of Maximum Plasma Concentration (Tmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.||hours||Full Range|Median
14729|NCT01910181|Primary|Cmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||μg/mL||Standard Deviation|Mean
14730|NCT01910181|Primary|Maximum Plasma Concentration (Cmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.||μg/mL||Standard Deviation|Mean
14731|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
14732|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
14733|NCT01910181|Primary|AUC of RO5185426 From 0 to 8 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.||h*μg/mL||Standard Deviation|Mean
14734|NCT01910181|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 From 0 to 8 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in hours by micrograms per milliliter (h*μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 1|PK Population: All participants who provided evaluable data for PK analysis and did not have a significant protocol violation/deviation.||h*μg/mL||Standard Deviation|Mean
14735|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baselie and 16 weeks|||participants|||Number
14736|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 12 weeks|||participants|||Number
14737|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 8 weeks|||participants|||Number
14738|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 4 weeks|||participants|||Number
14739|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|12 weeks and 16 weeks|||participants|||Number
14740|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|8 weeks and 12 weeks|||participants|||Number
14741|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|4 weeks and 8 weeks|||participants|||Number
14742|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|Baseline 4 weeks|||participants|||Number
14743|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks|||Joints||Inter-Quartile Range|Median
14744|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks|||Joints||Inter-Quartile Range|Median
14745|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks|||Joints||Inter-Quartile Range|Median
14746|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks|||Joints||Inter-Quartile Range|Median
14747|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks|||joints||Inter-Quartile Range|Median
14748|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks|||joints||Inter-Quartile Range|Median
14751|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
14752|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
14753|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
14754|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
14755|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
14756|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
14757|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
14758|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
14759|NCT01910116|Secondary|AUSCAN Function Change at 16 Weeks From Baseline|"Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
14760|NCT01910116|Secondary|AUSCAN Function Change at 12 Weeks From Baseline|"Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
14761|NCT01910116|Secondary|AUSCAN Function Change at 8 Weeks From Baseline|"Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
14762|NCT01910116|Secondary|AUSCAN Function Change at 4 Weeks From Baseline|"Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Basline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
14763|NCT01910116|Secondary|AUSCAN Stiffness at 16 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 16 weeks|||units on a scale||Inter-Quartile Range|Median
14764|NCT01910116|Secondary|AUSCAN Stiffness at 12 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Basline and 12 weeks|||units on a scale||Inter-Quartile Range|Median
14765|NCT01910116|Secondary|AUSCAN Stiffness at 8 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|baseline and 8 weeks|||units on a scale||Inter-Quartile Range|Median
14766|NCT01910116|Secondary|AUSCAN Stiffness at 4 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
14767|NCT01910116|Secondary|AUSCAN Pain Score at 16 Weeks From Baseline|"Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks|||units on a scale||Inter-Quartile Range|Median
14768|NCT01910116|Secondary|AUSCAN Pain Score at 12 Weeks From Baseline|"Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 12 weeks|||units on a scale||Inter-Quartile Range|Median
14769|NCT01910116|Secondary|AUSCAN Pain Score at 8 Weeks From Baseline|"Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 8 weeks|||units on a scale||Inter-Quartile Range|Median
14770|NCT01910116|Primary|AUSCAN Pain Change at 4 Weeks From Baseline|"Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100).~AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks|||units on a scale||Inter-Quartile Range|Median
14771|NCT01910064|Secondary|Changes From Baseline in Total Lesion Counts||Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12|||percentage of the reduction from baselin||Full Range|Median
14772|NCT01910064|Primary|Local Tolerability (Stinging/Burning)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months|||subjects|||Number
14773|NCT01910064|Primary|Local Tolerability (Pruritus)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months|||participants|||Number
14774|NCT01910064|Primary|Local Tolerability (Dryness)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months|||participants|||Number
14775|NCT01910064|Primary|Local Tolerability (Scaling)|Highest severity of Local tolerability scores worth than base line|12 months|||participants|||Number
14776|NCT01910064|Primary|Local Tolerability (Erythema)|Highest severity of Local tolerability scores worth than base line|12 monhths|||participants|||Number
14777|NCT01909804|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
14778|NCT01909804|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
14779|NCT01909804|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
14780|NCT01909804|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
14781|NCT01909778|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from intake of the second dose Faldaprevir up to 9 days|Only one patient was treated and completed this study; he was the only patient analyzed.||participants|||Number
14782|NCT01909778|Secondary|Assessment of Tolerability by Investigator|The investigator has assessed tolerability based on adverse events and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 1=“good”, 2=“satisfactory”, 3=“not satisfactory”, and 4=“bad”.|Day 6 of period 1 and 2|Only one patient was treated and completed this study; he was the only patient analysed.||units on a scale|||Number
14783|NCT01909778|Secondary|MRTpo|Mean residence time of the analyte in the body after oral administration (MRTpo).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||hours||Standard Deviation|Mean
14784|NCT01909778|Secondary|Vz/F|Apparent volume of distribution during the terminal phase (Vz/F) following an extravascular dose (at steady state).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||Liter|||Number
14785|NCT01909778|Secondary|CL/F|"Apparent clearance of the analyte in plasma following extravascular administration (CL/F).~The apparent clearance after oral administration will be determined according to the following equation: CL or CL/F=dose/AUC0-∞. (F=absolute bioavailability factor)"|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||mL/min|||Number
14786|NCT01909778|Secondary|t1/2|Elimination half-life (t1/2). The terminal half-life will be calculated from the terminal rate constant.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||hours|||Number
14787|NCT01909778|Secondary|AUC0-tz|Area under the concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUC0-tz).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||h*ng/mL|||Number
14788|NCT01909778|Secondary|Tmax|Time at which the maximum plasma concentration occurs (tmax). Individual tmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||hours|||Number
14789|NCT01909778|Primary|Cmax|Maximum plasma concentration (Cmax). Individual Cmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||ng/mL|||Number
14790|NCT01909778|Primary|AUC 0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.||h*ng/mL|||Number
14791|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Moisturizer|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).|Day 22|||participants|||Number
14792|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).|Day 22|||participants|||Number
14793|NCT01909713|Secondary|Hydration (Corneometry)|"Hydration was assessed using corneometry at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Corneometry measures the hydration status of the skin. An increase in corneometry values indicates an increase in the hydration status of the skin, and vice versa. The test is procedure specific, so results are reported in arbitrary units."|Week 3|||arbitrary units||Standard Deviation|Mean
14794|NCT01909713|Secondary|Barrier Function (TEWL)|Barrier function was assessed by measuring transepidermal water loss (TEWL) at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). TEWL measures water loss through the epidermis (for example, by evaporation). Measuring TEWL is a well-established way to assess the skin’s water-barrier function. High TEWL values indicate impaired skin barrier function; low values indicate normal barrier function.|Week 3|||g/m2/h||Standard Deviation|Mean
14795|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Tightness: 0 = none, no tightness; 1 = mild, slight tightness, not really bothersome; 2 = moderate, definite tightness sensation that is somewhat bothersome; 3 = severe, tightness sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3|||participants|||Number
14796|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Stinging: 0 = none, no stinging; 1 = mild, slight stinging sensation, not really bothersome; 2 = moderate, definite stinging sensation that is somewhat bothersome; 3 = severe, stinging sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3|||participants|||Number
14797|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Burning: 0 = none, no burning; 1 = mild, slight burning sensation, not really bothersome; 2 = moderate, definite warm, burning sensation that is somewhat bothersome; 3 = severe, hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3|||participants|||Number
14798|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Roughness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin.|Week 3|||participants|||Number
14799|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Dryness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling.|Week 3|||participants|||Number
14800|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Edema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense.|Week 3|||participants|||Number
14801|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Itching: 0 = none, no itching; 1 = mild, slight itching, not really bothersome; 2 = moderate, definite itching that is somewhat bothersome; 3 = severe, intense itching that may interrupt daily activities and/or sleep|Week 3|||participants|||Number
14802|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Erythema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema.|Week 3|||participants|||Number
14803|NCT01909570|Other Pre-specified|Live Birth Delivery Rate|The delivery of a healthy child (o two)|38 weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.||percentage of live birth|||Number
14804|NCT01909570|Secondary|Multiple Pregnancy Rate|A multiple clinical pregnancy was defined by the presence of more tan one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.||percentage of multiple pregnancies|||Number
14805|NCT01909570|Primary|Clinical Pregnancy Rate|A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.||percentage of pregnancy per transfer|||Number
14806|NCT01909466|Secondary|Mean Change From Baseline in Social Integration Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14807|NCT01909466|Secondary|Mean Change From Baseline in Emotional Regulation Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14808|NCT01909466|Secondary|Mean Change From Baseline in Physical Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14809|NCT01909466|Secondary|Mean Change From Baseline in Self Control Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14826|NCT01909180|Primary|Image Quality|"Image quality assessment on a 5 point Likert Scale:~5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information~1= Non-Diagnostic"|24 hours|All cases were sufficient and had acceptable, good or excellent image quality||units on a scale|Participants|Standard Deviation|Mean
14827|NCT01909141|Other Pre-specified|Safety of Pioglitazone as Regards Serum Creatinine|serum creatinine was measured at the end of the study period (after 3 months) in both groups.|3 months|||mg/dL||Standard Deviation|Mean
14828|NCT01909141|Secondary|Pregnancy Rate||3 months|||participants|||Number
14829|NCT01909141|Secondary|Endometrial Thickness||3 months|||mm||Standard Deviation|Mean
14830|NCT01909141|Secondary|Number of Follicles>18mm.||3 months|||follicles||Standard Deviation|Mean
14810|NCT01909466|Secondary|Mean Change From Baseline in Mental Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14811|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. The total score from the scale ranges from 20 (bad subjective experience) to 120 (perfect subjective experience).|Baseline to Week 20+|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14812|NCT01909466|Secondary|Clinical Global Impression-Improvement (CGI-I) Score.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14813|NCT01909466|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14814|NCT01909466|Secondary|Mean Change From Baseline in PANSS Negative Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14815|NCT01909466|Secondary|Mean Change From Baseline in PANSS Positive Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14816|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14817|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe).|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14818|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Overall AIMS scores range from 0 to 42.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14819|NCT01909466|Primary|Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).|The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). The SAS Total Score was the sum of the scores for all 10 items. SAS total score can range from 10 to 50. Each item was rated on a 5-point scale, with a score of 1 =absence of symptoms and a score of 5 =severe condition.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14820|NCT01909466|Primary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).|Suicidality was monitored throughout the trial using C-SSRS. The C-SSRS addresses the need for standardized classification of suicide reports to assess suicide risk. This scale consisted of Baseline evaluation that assessed the lifetime experience of the participant with suicidal events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit. The C-SSRS since last visit form were completed on Day 1 pre-dose and prior to dosing on Days 29, 57, 85, 113, 141/ Early Termination(ET) and prior to pharmacokinetics(PK) sampling on Days 8, 15, 22, 120, 127 and 134. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore,the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.|Baseline to Last Visit (Day 141)|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14821|NCT01909466|Primary|Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.|Participants assessed the pain associated with injection of aripiprazole IM using the VAS instrument. This was done approximately 30 minutes pre-dose and 1 hour (±15 min) Post-dose on Days 1, 29, 57, 85 and 113. For the first injection, the pre-dose assessment was of the current injection site. For the injections 2 through 5, the pre-dose assessment was of the prior injection site. Investigator's Assessment of Most Recent Injection Site including pain, swelling, redness, and induration were reported in 4-point categorical scale (1 = absent, 2 = mild, 3 = moderate and 4 = severe) by first injection site at each injection.|Days 1 and 113|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.||Units on a scale||Standard Deviation|Mean
14822|NCT01909466|Primary|Number of Participants With Adverse Events (AEs).|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|AEs were recorded from the time the informed consent was signed until follow-up for 28 days after last|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation.||participants|||Number
14823|NCT01909336|Secondary|Adverse Reactions Attributed to Acute Plasma Sodium Changes|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours|8 hours|||Minor Adverse Reactions|||Number
14824|NCT01909336|Secondary|Dysnatraemias at T8|hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)|8 hours|||participants|||Number
14825|NCT01909336|Primary|Hospital Acquired Hyponatremia|Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study|8 hours|||participants|||Number
14831|NCT01909141|Primary|Ovulation Rate||3 months|||percentage of all cycles|||Number
41442|NCT01438229|Primary|Adverse Events|All device or procedure related adverse events|24 months|All subjects receiving renal artery ablation procedure||percentage of participants|||Number
14832|NCT01909011|Primary|Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2|BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|Intent to treat population (all participants who received at least one dose of intervention). Last observation carried forward (LOCF) imputation method.||units on a scale||Standard Deviation|Mean
14833|NCT01909011|Secondary|Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2|CGI-S instrument measures the level of severity of illness rated by a qualified clinician. CGI-S values range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|||units on a scale||Standard Deviation|Mean
14834|NCT01909011|Secondary|Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2|Q-LES-Q is a validated 16-item self-report measure of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning such as physical well-being, work, home, social relationships and leisure activities. Each item is rated on a 1 - 5 point scale. Q-LES-Q values range from 0 (very low quality of life) to 100 (high quality of life). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|||units on a scale||Standard Deviation|Mean
14835|NCT01908842|Secondary|VAS Craving Scores: Stabilization/Maintenance|"Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 3 through 22|Full analysis population||units on a scale||Standard Deviation|Mean
14836|NCT01908842|Secondary|Visual Analog Scale (VAS) Cravings: Induction|"Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 1 and 2|Full Analysis Population||units on a scale||Standard Deviation|Mean
14837|NCT01908842|Secondary|SOWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable|Days 3 through 22|Full Analysis Population||units on a scale||Standard Deviation|Mean
14838|NCT01908842|Primary|Primary Endpoints of Retention in Treatment at Days 3 and 15|Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.|Day 3 and Day 15|Per protocol population||participants|||Number
14839|NCT01908842|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction|Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable|Days 1 and 2|Full analysis population||units on a scale||Standard Deviation|Mean
14840|NCT01908842|Secondary|COWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable|Days 3 through 22|Full analysis population||units on a scale||Standard Deviation|Mean
14841|NCT01908842|Secondary|Clinical Opiate Withdrawal Scale (COWS) Scores: Induction|Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable|Days 1 and 2|Full Analysis Population||units on a scale||Standard Deviation|Mean
14842|NCT01908803|Secondary|Median Time (in Days) to Cessation of Otorrhea|Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.|Time to event, up to Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.||days||Standard Error|Median
14843|NCT01908803|Secondary|Proportion of Subjects With Microbiological Success at the Day 8 Visit|Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.|Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.||percentage of subjects||Standard Deviation|Mean
14844|NCT01908803|Primary|Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit|A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.|Day 3 post-treatment up to Day 8 or Early Exit|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.||percentage of subjects|||Number
14845|NCT01908140|Secondary|Transition Dyspnoea Index (TDI) Focal Score at Week 24|The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 (“major deterioration”) to zero (“no change”) to +3 (“major improvement”). Category scores are added to compute the Focal Score (from -9 to 9)|At Week 24|PP population defined as a subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol.||TDI Focal Score|Participants|Standard Error|Least Squares Mean
14846|NCT01908140|Primary|Peak Forced Expiratory Volume in One Second (FEV1) at Week 24|Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration|At Week 24|"ITT population: randomized patients who took at least one dose of IMP and have a baseline FEV1 assessment.~PP population: subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol."||Liters|Participants|Standard Error|Least Squares Mean
14872|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||% of volume||Standard Deviation|Mean
14847|NCT01908127|Secondary|Index of Heart Rate|The heart rate of children was measured before the injection of local anesthesia solution to save a baseline data and it was also measured after the injection to assess the effect of this dental stress.|before and after the injection of local anesthesia solution|||beat per Min||Standard Deviation|Mean
14848|NCT01908127|Primary|Behaviors of Children|"A video-camera was focused started to record child’s behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children’s anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used.~Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact~Table 2: Frankle 4-point Index~1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)"|participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks|||units on a scale||Standard Deviation|Mean
14849|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||% of volume||Standard Deviation|Mean
14850|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||% of volume||Standard Deviation|Mean
14851|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/mL||Standard Deviation|Mean
14852|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/mL||Standard Deviation|Mean
14853|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
14854|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
14855|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mmol/L||Standard Deviation|Mean
14856|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mmol/L||Standard Deviation|Mean
14857|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
14858|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mg/dL||Standard Deviation|Mean
14859|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mEq/L||Standard Deviation|Mean
14860|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mEq/L||Standard Deviation|Mean
14861|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||mmHg at 37° C||Standard Deviation|Mean
14862|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||pCO2 (mmHg at 37° C)||Standard Deviation|Mean
14863|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||pH||Standard Deviation|Mean
14864|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||pH (at 37° C)||Standard Deviation|Mean
14865|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||g/dL||Standard Deviation|Mean
14866|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||g/dL||Standard Deviation|Mean
14867|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||10E3 cells/µL||Standard Deviation|Mean
14868|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||10E3 cells/µL||Standard Deviation|Mean
14869|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/g Hgb||Standard Deviation|Mean
14870|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||µmol/g Hgb||Standard Deviation|Mean
14871|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||volume % of red blood cells||Standard Deviation|Mean
14873|NCT01907906|Secondary|Neoantigenicity - Day 42 Indirect Antigen Test (IAT)|IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 42 of both Treatment Periods 1 and 2.||Positive results|||Number
14874|NCT01907906|Secondary|Neoantigenicity - Day 42 Direct Antigen Test (DAT)|DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test||Positive results|||Number
14875|NCT01907906|Secondary|Neoantigenicity - Day 21 Indirect Antigen Test (IAT)|Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 21 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2||Positive results|||Number
14876|NCT01907906|Secondary|Neoantigenicity - Day 21 Direct Antigen Test (DAT)|DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.|Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2||Positive results|||Number
14877|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
14878|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
14879|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
14880|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
14881|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
14882|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Spearman's Correlation Coefficient|||Number
14883|NCT01907906|Secondary|Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival|Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.||Days * Percent Recovery||Standard Deviation|Mean
14884|NCT01907906|Secondary|Red Blood Cell (RBC) Survival by Product|Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.|28 days|All subjects who signed informed consent,were eligible, had no intercurrent illness or notable signs/symptoms in 24 hrs prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had ≥ 4 blood samples collected within the first 22 min 30 sec post-infusion in each treatment period.||Days||Standard Deviation|Mean
14885|NCT01907906|Primary|Red Blood Cell (RBC) 24-Hour Recovery|"To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days.~24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days."|24 hours|All subjects who signed an IC form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected during the first 22 min, 30 sec post-infusion in each treatment period.||% 24-hour RBC Recovery||Standard Deviation|Mean
14886|NCT01907854|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.|During 26 weeks of treatment plus one week follow-up period.|Safety analysis set-All randomised subjects receiving at least one dose of any of the trial product.||number of events|||Number
14887|NCT01907854|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)|Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|After 26 weeks of treatment|FAS-All randomised subjects receiving at least one dose of any of the trial product.||percentage (%)|||Number
14888|NCT01907854|Secondary|Change in Systolic Blood Pressure and Diastolic Blood Pressure|Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product||mmHg||Standard Deviation|Mean
14889|NCT01907854|Secondary|Change in Fasting Blood Lipids|Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.|From baseline to week 26|FAS-All randomised subjects receiving at least one dose of any of the trial product. There were missing baseline values for free fatty acids in 1 subject in the liraglutide arm and 6 subjects in the sitagliptin arm.||ratio||Standard Deviation|Mean
14890|NCT01907854|Secondary|Change in Fasting Plasma Glucose|Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.||nmol/L||Standard Deviation|Mean
14891|NCT01907854|Secondary|Change in Body Weight|Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.||kg||Standard Deviation|Mean
14892|NCT01907854|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).|From baseline to week 26|Full analysis set (FAS) -All randomised subjects receiving at least one dose of any of the trial product.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
14893|NCT01907516|Secondary|Subject Satisfaction|Satisfaction was measured with a survey after completing using both reporting methods|6 weeks|||percentage of participants|||Number
14894|NCT01907516|Primary|Compliance With Home Blood Glucose Reporting|Compliance was calculated as a percentage for each method (Confidant or Voicemail) by dividing the total number of reported glucose readings among all participants by the total number of expected readings (4 daily) over the 6 week study time period. Women with gestational diabetes are instructed to monitor their glucose 4 times per day.|6 weeks|||percentage of expected glucose tests|||Number
14895|NCT01907490|Secondary|PK Parameters: AUC|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||12/2015||||
14896|NCT01907490|Secondary|PK Parameters: Tmax|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||12/2015||||
14897|NCT01907490|Secondary|Pk Parameters: Cmax|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||12/2015||||
14898|NCT01907490|Primary|Number of the Subjects With AEs.|Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.|3 months|paediatric population, children between ages 6 months to <18 years.||participants|||Number
14899|NCT01907334|Primary|Total Airway Resistance Increase|concentration of methacholine required to increase total airway resistance by 40% (PC40R5)|1 to 7 days|The analysis was performed on all 10 participants.||ln(mg/mL)||95% Confidence Interval|Geometric Mean
14900|NCT01907321|Secondary|Cough Expiratory Airflow|Cough airflow measure of peak expiratory flow rate|Change in baseline to 7 weeks|14 adults with a history of ischemic stroke in the previous 2 years. All but two participants (1 male, 1 female) completed the protocol.||Liters of air/second||Standard Deviation|Mean
14901|NCT01907321|Primary|Maximum Expiratory Pressure|This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.|Change in baseline to week 7|Data from 14 adults with a history of ischemic stroke was analyzed for changes in maximum expiratory pressure generating capacity, cough strength, and swallowing safety. All but 2 participants (1 male, 1 female) completed the protocol. Intent to treat analysis was used.||cm H2O (pressure measurement)||Standard Deviation|Mean
14902|NCT01907113|Secondary|Assessment of Tolerability by Investigator|Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation.|Drug administration until end-of-study-examination, 5 days|Treated set||participants|||Number
14903|NCT01907113|Secondary|Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements|Number of participants with clinically relevant findings in physical examination, Vital Signs, Clinically Significant Abnormalities in Electrocardiogram (ECG) and Significant Changes from Baseline Laboratory Measurements|Drug administration until end-of-study-examination, 5 days|Treated set||participants|||Number
41609|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban Acylglucuronide After Three Days of 15 mg IV Daily in HRS Type 1 Patients||3 days|||ng/mL||Standard Deviation|Mean
14904|NCT01907113|Secondary|Total Urinary Glucose Excretion (UGE)|Change from baseline in total urinary glucose excretion|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE)|The UGE analysis set included all patients in the treated set who provided the baseline value from 0 to 24 hours before drug administration and the value for urinary glucose excretion from 0 to 24 hours after drug administration without important protocol violations relevant to the evaluation of Pharmacodynamics.||mg||Standard Error|Mean
14905|NCT01907113|Secondary|Plasma Protein Binding|"Plasma protein binding is the percent of analyte binding to the plasma protein, pre-dose plasma samples were spiked with Empa 1000 nmol/L.~The standard deviation is actually the coefficient of variation."|1 h before drug administration and 1:30 and 3:00 h after drug administration|PKS||percentage of plasma protein binding||Standard Deviation|Mean
14906|NCT01907113|Secondary|%AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity)|Percentage of area under the concentration-time curve of the analyte in plasma over the time interval from the time of the last quantifiable data point extrapolated to infinity|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||percent||Geometric Coefficient of Variation|Geometric Mean
14907|NCT01907113|Secondary|Renal Clearance of the Analyte in Plasma After Extravascular Administration|Renal Clearance of the Analyte in Plasma After Extravascular Administration for time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS||mL/min||Geometric Coefficient of Variation|Geometric Mean
14908|NCT01907113|Secondary|fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours)|Fraction of analyte excreted unchanged in urine from time point 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS||percentage of analyte||Geometric Coefficient of Variation|Geometric Mean
14909|NCT01907113|Secondary|Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h)|Amount of analyte that is eliminated in urine over the time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS||nmol||Geometric Coefficient of Variation|Geometric Mean
14910|NCT01907113|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
14911|NCT01907113|Secondary|Apparent Volume of Distribution During the Terminal Phase Lz|Apparent volume of distribution during the terminal phase Lz|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||L||Geometric Coefficient of Variation|Geometric Mean
14912|NCT01907113|Secondary|Apparent Clearance of the Analyte in the Plasma After Extravascular Administration|Apparent clearance of the analyte in the plasma after extravascular administration|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||mL/min||Geometric Coefficient of Variation|Geometric Mean
14913|NCT01907113|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma (Lz)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||1/h||Geometric Coefficient of Variation|Geometric Mean
14914|NCT01907113|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||h||Geometric Coefficient of Variation|Geometric Mean
14915|NCT01907113|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||h||Full Range|Median
14916|NCT01907113|Primary|Cmax (Maximum Concentration of the Analyte in Plasma)|Maximum concentration of Empagliflozin in plasma|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS||nmol/L||Geometric Coefficient of Variation|Geometric Mean
14917|NCT01907113|Primary|AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity)|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|The PK analysis set (PKS) included all evaluable patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
14918|NCT01906658|Secondary|Proportion of Subjects With Treatment Emergent Suicidality||Baseline to Week 36|||Participants|||Count of Participants
14919|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication||Baseline to Week 8|||Participants|||Count of Participants
14920|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation||Baseline to Week 8|||Participants|||Count of Participants
14922|NCT01906515|Primary|The Effect of SpHb on Transfusion Timeline|Length of time it takes to initiate a RBC transfusion after the need was first established.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.||minutes||95% Confidence Interval|Mean
14923|NCT01906515|Primary|RBC Transfusions Per Subject Receiving a Transfusion|Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.||units||95% Confidence Interval|Mean
14924|NCT01906515|Other Pre-specified|Potential Cost Savings|Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294.|During surgery (an average of about 4 hours)||||||
14925|NCT01906515|Secondary|SpHb Absolute and Trend Accuracy|To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated|During surgery (an average of about 4 hours)||||||
14926|NCT01905956|Secondary|Global Evaluation of Safety by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
14927|NCT01905956|Secondary|Global Evaluation of Safety by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
14928|NCT01905956|Secondary|Global Evaluation of Efficacy by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
14929|NCT01905956|Secondary|Global Evaluation of Efficacy by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.||subjects|||Number
14930|NCT01905956|Secondary|Food Craving Questionnaire (FCQ)|"This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale:~= I do not agree at all~= I do not agree~= Neutral~= I agree~= I highly agree~Results were expressed as the mean score for the whole population in the respective intervention group."|Baseline and 4, 8, and 12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the FCQ at all visits from v2 to v5. Missing data were appeared in 9 cases at visit v5 and additional in 8 cases at visit v4.||Units on a scale||Standard Deviation|Mean
14931|NCT01905956|Secondary|Mean Change in Body Fat Mass (kg) From Baseline to Week 12|"Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.||kilogram (kg)||Standard Deviation|Mean
14932|NCT01905956|Secondary|Mean Change in Body Fat Content (%) From Baseline to Week 12|"Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.||Percentage of body fat (%)||Standard Deviation|Mean
14933|NCT01905956|Secondary|Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12|"Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest.~Hip circumference (cm) was measured as the maximal circumference over the buttocks.~Results were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values)."|Baseline and 12 weeks|||centimetre (cm)||Standard Deviation|Mean
14934|NCT01905956|Primary|Mean Change in Body Weight From Baseline to Week 12|"Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values)."|Baseline and 12 weeks|||kilogram (kg)||Standard Deviation|Mean
14935|NCT01905657|Secondary|Duration of Response (DOR) by RECIST 1.1|DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized. Participants were included in the treatment group to which they were randomized.||Weeks||Full Range|Median
14936|NCT01905657|Secondary|Overall Response Rate (ORR) by RECIST 1.1|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) based on blinded independent central radiologists' review using RECIST 1.1.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
14937|NCT01905657|Primary|Percentage of Participants Discontinuing Study Drug Due to AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE.|Up to approximately 23 months|The APAT population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.||Percentage of Participants|||Number
14938|NCT01905657|Primary|Percentage of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days after last dose of study drug (serious AEs were monitored for up to 90 days after last dose of study drug).|AEs: Up to 30 days after last dose of study drug (Up to approximately 24 months). Serious AEs: Up to 90 days after last dose of study drug (Up to approximately 27 months).|The All Participants As Treated (APAT) population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.||Percentage of Participants|||Number
14939|NCT01905657|Primary|Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists’ review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
14940|NCT01905657|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The Intent-To-Treat population consisted of all participants who were randomized and were included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
14941|NCT01905553|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|||ng/mL||Standard Deviation|Mean
14942|NCT01905553|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions|AUClast is the area under the curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
14943|NCT01905553|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions|AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 Hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
14944|NCT01905540|Secondary|Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
14945|NCT01905540|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses|AUCinf is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
14946|NCT01905540|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*hr/mL||Standard Deviation|Mean
20560|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
14947|NCT01905540|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/mL||Standard Deviation|Mean
14948|NCT01905540|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose|AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/mL||Standard Deviation|Mean
14949|NCT01905540|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose|AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng*h/mL||Standard Deviation|Mean
14950|NCT01905254|Primary|Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis|The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy.|Transient Elastography compared to liver histology|Sensitivity, specifity; Positive and negative predictive value of TE for diagnosis of cirrhosis was analyzed.||Probability|||Number
14951|NCT01904773|Primary|Pharmacokinetics : AUC (h*ng/ ml) - Part 1 Only|Pharmacokinetics Part 1 only: Single dose Day 1 AZD5213 0.5 mg Area Under the Concentration time curve (AUC) 0 to infinity (h*ng/ml)|Day 1|Pharmacokinetic population||AUC (h*ng/ml)||Standard Deviation|Mean
14952|NCT01904773|Primary|Pharmacokinetics : Time to Maximum Concentration (hr) - Part 1 Only|Pharmacokinetics Part 1 only: Time to maximum plasma concentration (hr)Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population||Time (hr)||Standard Deviation|Mean
14953|NCT01904773|Primary|Pharmacokinetics : Maximum Plasma Concentration (ng/ml) - Part 1 Only|Pharmacokinetics Part 1 only: Maximum plasma Concentration (ng/ml) Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population||Plasma concentration (ng/ml)||Standard Deviation|Mean
14954|NCT01904773|Primary|Total Tic Severity Score (Part 2 Only) Crossover Analysis Over 6 Periods|Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50|3 week period of treatment|All Part 2 participants||Total Tic Severity Score||Standard Error|Least Squares Mean
14955|NCT01904760|Other Pre-specified|Pain Score Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their pain score are evaluated by VAS method every afternoon on each of the 5 days. Patients' pain score on maxillofacial region and flap donation region are evaluated respectively.|on each of the 5 days postoperatively||||||
14956|NCT01904760|Other Pre-specified|Sleep Quality Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their sleep quality are evaluated every afternoon on each of the 5 days.|on each of the 5 days postoperatively||||||
14957|NCT01904760|Other Pre-specified|Overall Feeling in PACU|Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day||||||
14958|NCT01904760|Other Pre-specified|Sleep Quality in PACU|Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day||||||
14959|NCT01904760|Other Pre-specified|Pain Score in PACU|Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU.|at 8 am the next day||||||
14960|NCT01904760|Other Pre-specified|Use of Analgesics and Sedatives in PACU|extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them.|participants will be followed for the duration of PACU stay, an expected average of 12 hours||||||
14961|NCT01904760|Other Pre-specified|Patients' Vital Signs in PACU|Patient's vital signs including heart rate, blood pressure, pulse oxygen saturation and respiratory rate are monitored continuously in PACU and recorded on 1,2,4,6,12 hour after PACU admission.|participants will be followed for the duration of PACU stay, an expected average of 12 hours||||||
14962|NCT01904760|Secondary|Postoperative Delirium|Patients are sent back to wards the next morning after operation and followed up on each of the 5 days postoperatively. Delirium will be confirmed based on CAM-ICU method.|on each of the 5 days postoperatively|||participants|||Number
14963|NCT01904760|Primary|Agitation in PACU|Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.|participants will be followed for the duration of PACU stay, an expected average of 12 hours|||participants|||Number
14964|NCT01904721|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Intensity Units||Standard Deviation|Mean
14978|NCT01904149|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity – Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population||percentage of participants|||Number
14965|NCT01904721|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||mm/cm2||Standard Deviation|Mean
14966|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Percentage of Participants|||Number
14967|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Percentage of Participants|||Number
14968|NCT01904721|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||Percentage of Participants|||Number
14969|NCT01904721|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements||terminal hairs/cm2||Standard Deviation|Mean
14970|NCT01904604|Secondary|Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy|Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.|Month 30 (Week 130)||12/2019||||
14971|NCT01904604|Secondary|Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months|Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.|Week 52 and Month 30 (Week 130)|All randomized subjects who received study treatment.||percentage of participants|||Number
14972|NCT01904604|Secondary|Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC)|Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.|8 and 20 weeks after the Week 130 (Month 30) OFC||12/2019||||
14973|NCT01904604|Secondary|Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.|Week 52|All randomized subjects who completed the Week 52 OFC.||mg protein||Full Range|Median
14974|NCT01904604|Secondary|Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:~0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52.~BL=Baseline, Wk 52=Week 52"|Week 52|All randomized subjects who received active (not placebo) study treatment.||percentage of participants|||Number
14975|NCT01904604|Secondary|Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein|Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC).|Week 130 (Month 30)||12/2019||||
14976|NCT01904604|Secondary|Percentage of Subjects Desensitized to Peanut Protein|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:~1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130.~BL=Baseline, Wk 130=Week 130 (Month 30)"|Week 130 (Month 30)||12/2019||||
14977|NCT01904604|Primary|Percentage of Subjects With a Successful Treatment Response|Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.|Week 52|All randomized subjects who received study treatment.||percentage of participants|||Number
14991|NCT01904058|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|Laboratory serum ALP enzyme levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units per liter (U/L)||Standard Deviation|Mean
14979|NCT01904149|Secondary|SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.~PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population||units on a scale||Standard Deviation|Mean
14980|NCT01904149|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief – Verbal Rating Scale: pain relief 0=none, 4=complete) scores.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after first dose|ITT population||percentage of participants|||Number
14981|NCT01904149|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|ITT population||units on a scale||Standard Deviation|Mean
14982|NCT01904071|Other Pre-specified|Pain Score at 480 Minutes|Pain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|480 minutes|Pain scores were not obtained for 4 patients in the UFNB group, 3 patients in the UFIB group, and 3 patients in the IVMS group at 480 minutes||units on a scale||Standard Deviation|Mean
14983|NCT01904071|Other Pre-specified|Pain Score at 240 Minutes|Pain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|240 minutes|Pain score was not obtained for one patient in the UFNB group at 240 minutes||units on a scale||Standard Deviation|Mean
14984|NCT01904071|Other Pre-specified|Pain Score at 120 Minutes|Pain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|120 minutes|Pain score was not obtained for one patient in the IVMS group at 120 minutes.||units on a scale||Standard Deviation|Mean
14985|NCT01904071|Secondary|Pain Score at 60 Minutes|Pain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|60 minutes|||units on a scale||Standard Deviation|Mean
14986|NCT01904071|Primary|Pain Score at 30 Minutes|Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|30 minutes|||units on a scale||Standard Deviation|Mean
14987|NCT01904058|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the product. A serious adverse event (SAE) was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect; an important medical event that did not meet any of the above criteria but jeopardized the participant or required medical or surgical intervention to prevent one of the outcomes listed above. A TEAE was defined as any AE that occurred during the study, from the start of investigational product dosing through the end of the study (13 weeks of treatment period (or ET) + 14 days ]), or that worsened since the start of dosing.|From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)|The Safety Population included all participants who were randomized and received at least 1 dose of the study drug. One participant was randomized to LUM001 10 mg, but was down-titrated to 5 mg dose due to tolerability issues. The safety data has been summarized based on the study dose actually received by the participant.||participants|||Number
14988|NCT01904058|Secondary|Change From Baseline in Bile Acid Synthesis as Measured by Serum 7 Alpha-Hydroxy-4-Cholesten-3-One C4 Level [7 Alpha C4]) at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|C4 7 alpha-hydroxy-4-cholesten-3-one is an intermediate in the biochemical synthesis of bile acids from cholesterol and its concentrations reflect the activity of the bile acid synthetic pathway. Elevated levels of C4 indicate bile acid malabsorption. Laboratory C4 levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline Visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
14989|NCT01904058|Secondary|Change From Baseline in Fasting Serum Bile Acid Level at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|Laboratory serum bile acid level levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||micromoles per liter||Standard Deviation|Mean
14990|NCT01904058|Secondary|Change From Baseline in 5-D Itch Score at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|The 5-D itch (validated instrument to measure pruritus) scale was developed for the multidimensional quantification of pruritus that is sensitive to change over time. The 5-D itch scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units on a scale||Standard Deviation|Mean
20561|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
14992|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Average Daily Scores at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. Adult ItchRO average daily score was the sum of daily scores divided by the number of days adult ItchRO was completed, using the 7 days prior to the reported visit date.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units on a scale||Standard Deviation|Mean
14993|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Weekly Sum Scores at Weeks 4, 8 and 13|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline, Weeks 4, 8 and 13|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.||units on a scale||Standard Deviation|Mean
14994|NCT01904058|Primary|Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET)|Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline and Week 13/ET|The mITT population included all participants who were randomized, received at least 1 dose of treatment, and had at least 1 post-baseline ItchRO assessment.||units on a scale||Standard Deviation|Mean
14995|NCT01903876|Secondary|Sexual Violence Perpetration|This scale is the Conflict Tactics Scale revised, Sexual Coercion Subscale and assessed the number of sexually coercive/violent behaviors engaged in during the past 6 months. The index ranges from 0 (no engagement in any sexual violence) to 7 (engaged in all 7 sexually violent behaviors).|6 months|For some of the variables in this analysis, there were missing data. ANCOVA performed in SPSS will use a listwise deletion. This resulted in n=87 and n=115 for this analysis.||score on a scale||Standard Error|Mean
14996|NCT01903876|Primary|Prosocial Intervening Behavior|This scale is the Reactions to Offensive Language and Behavior (ROLB) index that measures whether or not men confronted inappropriate behaviors of other men. We used the 7-item self-behavior subscale plus an additional 8 items, which directly reflected the content of RealConsent. A series of 15 potential intervening situations were presented and participants were asked to indicate whether they had experienced this situation in past 6 months (yes/no), and whether they had intervened (yes/no). The scale ranged from 0% (did not intervene anytime) to 100% (intervened every time).|6 months|||percent score on a scale||Standard Error|Mean
14997|NCT01903720|Secondary|Percentage of Participants Who Received Laser Treatments|Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.|12 Months|ITT population included all enrolled participants.||percentage of participants|||Number
14998|NCT01903720|Secondary|Time to Third Injection|Time in weeks from the second injection to the third injection.|12 Months|ITT population included all enrolled participants.||weeks||Standard Deviation|Mean
14999|NCT01903720|Secondary|Time to Second Injection|Time in weeks from the first injection to the second injection.|12 Months|ITT population included all enrolled participants.||weeks||Standard Deviation|Mean
15000|NCT01903720|Secondary|Percentage of Participants Receiving a Third Injection||12 Months|ITT population included all enrolled participants.||percentage of participants|||Number
15001|NCT01903720|Secondary|Percentage of Participants Receiving a Second Injection||12 Months|ITT population included all enrolled participants.||percentage of participants|||Number
15002|NCT01903720|Secondary|Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.|Baseline, Months 6 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."||percentage of participants|||Number
15003|NCT01903720|Secondary|Change From Baseline in CRT at Each Visit|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."||micrometers (μm)||Standard Deviation|Mean
15004|NCT01903720|Secondary|Change From Baseline in BCVA at Each Visit|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."||letters||Standard Deviation|Mean
15005|NCT01903720|Secondary|Change From Baseline in CRT at Month 12|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."||μm||Standard Deviation|Mean
16730|NCT01850394|Primary|Total Hemoglobin Loss|Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day|5 days after surgery|Use intention-to-treat analysis||g/dL||Standard Deviation|Mean
15006|NCT01903720|Secondary|Change From Baseline in BCVA at Month 12|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."||letters||Standard Deviation|Mean
15007|NCT01903720|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Month 6|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 6|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."||micrometers (μm)||Standard Deviation|Mean
15008|NCT01903720|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 6|"Intent-to-treat (ITT) population included all enrolled participants. n in the category is the number of participants with data available for analysis."||letters||Standard Deviation|Mean
15009|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Pruritus as Measured by The Patient And Observer Itch Reported Outcome (ItchRO) Average Daily Scores|The ItchRO was administered as a twice daily electronic diary (eDiary). Children ≥9 years of age completed the patient ItchRO; those between the ages of 5 and 8 completed the patient ItchRO with the assistance of their caregiver. There was no patient report for subjects under the age of 5. ItchRO scores range from 0 to 4, with the higher score indicating increasing itch severity. ItchRO average daily scores were calculated as the sum of daily scores (ie, the maximum of morning and evening scores) divided by the number of days. The average daily score was calculated by using the 7 days pre-treatment for baseline, and the last 7 days of treatment for Week 13. A negative change from Baseline indicates that itch severity decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.||units on a scale||Standard Error|Least Squares Mean
15010|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Liver Enzymes|Analysis of liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP). A negative change from baseline indicates that the level of that enzyme decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.||U/L||Standard Error|Least Squares Mean
15011|NCT01903460|Primary|Change From Baseline to Week 13 (End of Treatment) in Fasting Serum Bile Acid Level|Participants were required to fast for at least 4 hours; only water was permitted prior to collection. A negative change from baseline indicates that the level of bile acid decreased.|Baseline to 13 weeks or end of treatment|The modified Intent-to-Treat (mITT) population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.||umol/L||Standard Error|Least Squares Mean
15012|NCT01903265|Secondary|Change From Baseline to Week 12 in FIQ-R Total Score|"The Fibromyalgia Impact Questionnaire (revised) FIQ-R is made up of 3 domains: functional (9 questions), overall (2 questions) and symptoms (10 questions). All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being worst. Total FIQ-R scores can range from 0-100, with higher scores reflecting worsening status. The patient's total score on the FIQ-R was assessed at Visits 2, 3, 4, 5, and 6 (Week 12). Jump to control was used to replace missing data in each treatment arm."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||units on a scale||Standard Error|Least Squares Mean
15013|NCT01903265|Secondary|Patient Global Impression of Change (PGIC) Responder Status (“Very Much Improved” or “Much Improved” vs All Other Categories) at Week 12|The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study. Scores of 1 and 2 were considered responders.|Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||percentage of participants|||Number
15014|NCT01903265|Secondary|Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance|The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||units on a scale||Standard Error|Least Squares Mean
15015|NCT01903265|Secondary|30% Responder Analysis of IVRS NRS Pain Assessments at Week 12|"The weekly averages of daily pain scores were calculated using the daily, 24-hour-recall, IVRS NRS pain assessments.~Patients who had at least a 30% improvement from baseline to week 12 in weekly average of daily pain scores were considered responders."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients.||percentage of participants|||Number
15016|NCT01903265|Primary|Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12|Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients||units on a scale||Standard Error|Least Squares Mean
15017|NCT01903187|Secondary|Reduction in Ambulatory Blood Pressure (ABP) Parameters|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|baseline, 6 months post randomization, and all follow-up timepoints||||||
15018|NCT01903187|Secondary|Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization, and all follow-up timepoints||||||
15019|NCT01903187|Secondary|The Number of Subjects That Experience Each Type of MAE|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization||||||
15020|NCT01903187|Secondary|Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization||||||
15021|NCT01903187|Primary|The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups||6 months post randomization|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct a comparison between groups.||mmHg||Standard Deviation|Mean
15022|NCT01903187|Primary|The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.|6 months post randomization|All subjects randomized to the EnligHTN procedure||percentage of participants|||Number
15023|NCT01903148|Secondary|Patients With Hb<11||1 day|||participants|||Number
15024|NCT01903148|Secondary|Iron Treatment|Patients with supplementary Iron treatment to ESA|1 day|||participants|||Number
15025|NCT01903148|Secondary|% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy|know the treatments ESA for maintenance of hb levels|1 day|||percentage of participants|||Number
15026|NCT01903148|Secondary|Patients With Hb>12||1 day|||participants|||Number
15027|NCT01903148|Secondary|Hemoglobin Levels Per Type of Patients|levels Hb and type of patients|1 day|n represents the number of participants analyzed for each category respectively (converted patients, naïve patients)||mg/dl||Standard Deviation|Mean
15028|NCT01903148|Primary|% Patients Achieving Target Hemoglobin Levels|% patients with Hb levels between 11-12 mg/dl|1 day because is a crosssectional study with only a visit|||percentage of participants|||Number
15029|NCT01903005|Primary|Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events|Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population||participants|||Number
15030|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Serious Adverse Events|Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 throught week 24|Safety population||participants|||Number
15031|NCT01903005|Primary|Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events|Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population||participants|||Number
15032|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Adverse Events|Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population||participants|||Number
15033|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||units on a scale||95% Confidence Interval|Mean
15034|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||hours||95% Confidence Interval|Mean
15065|NCT01901341|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15035|NCT01903005|Secondary|Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)|"Question 1 of the WPAI:SHP asks patients to provide a yes or no response to the question Are you employed?; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end"|Study Endpoint|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed||percentage of patients|||Number
15036|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores|"Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 (no cravings) to 100 mm (most intense craving I have ever had); study endpoint was defined as the last post-baseline value recorded for VAS craving"|Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data||units on a scale||95% Confidence Interval|Mean
15037|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score|Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data||units on a scale||95% Confidence Interval|Mean
15038|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score|Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint|Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data||units on a scale||95% Confidence Interval|Mean
15039|NCT01903005|Secondary|Retention in Treatment in the Safety Population|Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)|Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24|Safety population||participants||95% Confidence Interval|Number
15040|NCT01902888|Primary|Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.|30 day serious adverse events related to the initial study procedure or the study device.|30 days following initial study procedure||||||
15041|NCT01902888|Primary|Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.|A composite of freedom from failure of technical success or loss of primary patency at 12 months|12 months following initial study procedure||||||
15042|NCT01902758|Primary|Time (Minutes) to Complete 2 Miles on a Treadmill||after arriving at high altitude (within 1 hour)|||seconds||Standard Deviation|Mean
15043|NCT01902303|Secondary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant|The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered “aborted” or “blocked”. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.|0 -7 days|158 subjects randomized to treatment. 118 subjects used allocated assigned treatment (62 test article and 56 placebo). 7 subjects failed to complete and 111 completed study. For this secondary analysis (self assessments) 53 subjects noted prodrome occurring on Day 0.||participants with aborted lesions|||Number
15044|NCT01902303|Primary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator|The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered “aborted” or “blocked”. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.|Day 0- Day 7|Participants that did not experience prodrome stage as assessed by the evaluator or met major protocol violations were not included in the PP analysis.||participants who had aborted lesions|||Number
15045|NCT01902134|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief – Verbal Rating Scale: pain relief 0=none, 4=complete) scores.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|||percentage of participants|||Number
15046|NCT01902134|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity – Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|||percentage of participants|||Number
15250|NCT01895543|Primary|Number of Patients Using Concomitant Medications|The concomitant medications details were collected throughout the trial at all visits. Data were obtained at scheduled or unscheduled trial visits based on information provided spontaneously by the patient or as a result of questioning the patient.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
15047|NCT01902134|Secondary|SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.~PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|||units on a scale||Standard Deviation|Mean
15048|NCT01902134|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|||units on a scale||Standard Deviation|Mean
15049|NCT01901588|Secondary|Time to PACU Discharge||Length of PACU stay (around 3 hours on average)|||minutes||Standard Deviation|Mean
15050|NCT01901588|Secondary|Time to Arousal||Length of PACU stay (around 3 hours on average)|||minutes||Standard Deviation|Mean
15051|NCT01901588|Secondary|Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications||Length of PACU stay (around 3 hours on average)|||percentage of participants|||Number
15052|NCT01901588|Secondary|Post-op Pain Interventions||Length of PACU stay (around 3 hours on average)|||number of pain interventions/group|||Number
15053|NCT01901588|Secondary|Percentage of Participants Receiving Pain Medication||Length of PACU stay (around 3 hours on average)|||percentage of participants|||Number
15054|NCT01901588|Primary|Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery||Length of PACU stay (around 3 hours on average)|||percentage of participants|||Number
15055|NCT01901575|Primary|PVC Suppression With Remifentanil Sedation|1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression|duration of the operative procedure, average 2 hours|||participants with PVC suppression|||Number
15056|NCT01901575|Primary|Inhibition of Idiopathic Ventricular Tachycardia|"observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's.~Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation."|duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours||||||
15057|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity With Movement)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure||units on a scale (in mm)||Standard Deviation|Mean
15058|NCT01901393|Secondary|Incidence of Serious Adverse Events|Number of subjects experiencing treatment-emergent serious adverse events|Post-operative period until discharge, an expected average of 6 hours|||Number of events|||Number
15059|NCT01901393|Secondary|Patient Satisfaction|Measured using 2 question, 4 point scale.|Post-operative period until discharge, an expected average of 6 hours|||Participants|||Number
15060|NCT01901393|Secondary|Time to First Use of Rescue Med Will be Measured|Time to first rescue medication (in hours) in the postoperative period through discharge.|Post-operative period until discharge, an expected average of 6 hours|||hours||Standard Error|Mean
15061|NCT01901393|Secondary|Rescue Medication Use in Post-operative Period|Amount of rescue medication (in milligrams) will be measured|Post-operative period until discharge, an expected average of 6 hours|||milligrams||Standard Deviation|Mean
15062|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity at Rest)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure||units on a scale (in mm)||Standard Deviation|Mean
15063|NCT01901341|Other Pre-specified|Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.||participants|||Number
15064|NCT01901341|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15066|NCT01901341|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at the 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15067|NCT01901328|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|||participants|||Number
15068|NCT01901328|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15069|NCT01901328|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15070|NCT01901328|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15071|NCT01901302|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.||participants|||Number
15072|NCT01901302|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15073|NCT01901302|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15074|NCT01901302|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks|"A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week.~For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12)."|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.|||||
15075|NCT01901250|Primary|Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade|"The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.~For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the D and F portions of DFT, respectively."|baseline and middle of 2nd grade|||Number of surfaces||Standard Deviation|Mean
15108|NCT01898884|Secondary|Percentage of Drug Excreted in Urine at Steady-State (Ae%,ss) of VP 20629 for Multiple Dose Groups|The Ae%,ss is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||percentage of dose||Standard Deviation|Mean
15076|NCT01901185|Other Pre-specified|Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study. The definition includes worsening of a pre-existing medical condition. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. An adverse device effect is any adverse event related to the use of a medical device. Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.|9 weeks|Safety population||participants|||Number
15077|NCT01901185|Secondary|Percentage of Errors in Each Step of the Self-injection Process|For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported. If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not. • Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.||percentage of errors|Participants||Number
15078|NCT01901185|Secondary|Percentage of Autoinjector A System Failures|The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers. System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.||percentage of system failures|Participants|95% Confidence Interval|Number
15079|NCT01901185|Primary|Percentage of Successful Self-injections to Total Non-missed Injections|The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set defined as all nonmissed injections using Autoinjector A during Weeks 1 to 5 for all enrolled participants; in the event of multiple injection attempts, only the last attempt per week was counted.||percentage of successful injections|Participants|95% Confidence Interval|Number
15080|NCT01900249|Primary|Change of Corneal Fluorescein Staining of the Inferior Cornea Region.|Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.|Baseline to Week 12|The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population.||units on a scale (Likert)||95% Confidence Interval|Mean
15081|NCT01900067|Primary|The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group|The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period|temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.|||Degree Celsius (°C)||95% Confidence Interval|Mean
15082|NCT01900054|Secondary|Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)||Week 12 or suspension||||||
15083|NCT01900054|Secondary|Influence of Activities in Daily Life(Study, Outing, Sleeping)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
15084|NCT01900054|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
15085|NCT01900054|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
15086|NCT01900054|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12||||||
15087|NCT01900054|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).|Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）|||units on a scale||Standard Deviation|Median
15088|NCT01900054|Primary|Number of Patients With Adverse Events and Adverse Drug Reactions||Up to Week 12|||participants|||Number
15089|NCT01899911|Primary|Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level|Successful capture of SpO2 levels - Infrared and red light absorbency was measured and used for SpO2 percentage calculation from both the Vital Signs Patch (VSP) study device and an invasive Blood Arterial Hemoximeter (standard method) to determine the level of accuracy of data obtained from the VSP device when compared data taken from the Arterial Hemoximeter. A comparison was made by calculating the Average Root Mean Square (Arms) and comparing against the Arms error rate limit of less than or equal to 3.5% at a 95% confidence level. The outcome is either positive or negative - this is a composite outcome measure.|within 24 hrs|Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants||participants|||Number
15276|NCT01895322|Primary|Change in Daily Urine Volume From Baseline|Change in daily urine volume from baseline during the repeated-administration period (For five days).|Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.|||mL||Standard Deviation|Mean
15090|NCT01899742|Secondary|Change From BL in FEV1 at 3 Hours Postdose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. FEV1 assessments taken on 0 to 3 hour on Day 84 (pre-dose, 5 minutes (min), 15 min, 30 min, 1 hour, and 3 hour post-dose). Pre-dose was the reading obtained at 24 hours after the previous day’s dose (Day 83 dose). BL is defined as mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last OL tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Analysis performed using mixed model repeated measures with covariates of treatment, BL FEV1, center group, 24 hour subset flag, time, time by treatment interaction and time by BL interaction. Only those participants with data available at the specified time point were included in the analysis.|Baseline and Day 84|ITT Population||Liters||Standard Error|Least Squares Mean
15091|NCT01899742|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last open label [OL] tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 84 (at Week 12 + 1 day). Analysis performed using a mixed repeated measures model (MMRM) with covariates of treatment, BL, center group, 24 hour subset flag, Day, Day by BL and Day by treatment interactions. ITT Population is defined as participants who received at least one dose of randomized study medication in the treatment period. Only those participants with data available at the specified time point were included in the analysis.|Baseline (BL) and Day 85|ITT Population||Liters||Standard Error|Least Squares Mean
15092|NCT01899677|Primary|Interferon Levels at 28+/-2 Days||28+/-2 days|||pg/ml||Inter-Quartile Range|Median
15093|NCT01899677|Primary|Interferon Levels at 14+/-2 Days||14+/-2 days|||pg/ml||Inter-Quartile Range|Median
15094|NCT01899677|Primary|Interferon Levels at 0+2 Days||0+2 days|||pg/ml||Inter-Quartile Range|Median
15095|NCT01899677|Primary|Interleukin 17A Levels at 28+/-2 Days||28+/-2 days|||pg/ml||Inter-Quartile Range|Median
15096|NCT01899677|Primary|Interleukin 17A Levels at 14+/- 2 Days||14+/- 2 days|||pg/ml||Inter-Quartile Range|Median
15097|NCT01899677|Primary|Interleukin 17A Levels at 0+2 Days||0+2 days|||pg/ml||Inter-Quartile Range|Median
15098|NCT01899677|Primary|Interleukin 10 Levels at 28+/-2 Days||28+/-2 days|||pg/ml||Inter-Quartile Range|Median
15099|NCT01899677|Primary|Interleukin 10 Levels at 14+/- 2 Days||14+/- 2 days|||pg/ml||Inter-Quartile Range|Median
15100|NCT01899677|Primary|Interleukin 10 Levels at 0+2 Days||0+2 days|||pg/ml||Inter-Quartile Range|Median
15101|NCT01899677|Primary|Interleukin 5 Levels at 28+/-2 Day||28+/-2 day|||pg/ml||Inter-Quartile Range|Mean
15102|NCT01899677|Primary|Interleukin 5 Levels on 14+/-2 Day||14+/-2 day|||pg/ml||Inter-Quartile Range|Median
15103|NCT01899677|Primary|Interleukin 5 Serum Cytokine Level on 0+2 Day||0+2 day|||pg/ml||Inter-Quartile Range|Median
15104|NCT01899144|Secondary|Participants With Treatment-Emergent Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).~Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|Day 1 up to Day 35|The safety population included all randomized patients who received at least 1 dose of randomized study medication. In this population, treatment was assigned based upon the treatment patients actually receive regardless of the treatment to which they were randomized.||participants|||Number
15105|NCT01899144|Secondary|Baseline-Adjusted Area-Under-The- Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose (FEV1 AUC0-6)|FEV1 AUC0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose FEV1 values from each post-dose FEV1 determination.|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set||L*hour||Standard Error|Mean
15106|NCT01899144|Primary|Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics. Predicted FEV1 values were computed and adjusted for age, height, and gender for patients aged 4-5 years (Eigen et al 2001) and for patients aged 6-11 years (Quanjer et al 1995) using ATS/European Thoracic Society (ERS) criteria applicable to pediatric patients (ATS/ERS 2007).~The percent predicted FEV1 (PPFEV1) area under the curve (AUC)0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose PPFEV1 values from each post-dose PPFEV1 determination."|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of study medication, had a baseline assessment, and had at least 1 post baseline assessment.||%predicted FEV1*hour||Standard Error|Mean
15107|NCT01898884|Secondary|Renal Clearance at Steady State (CLR,ss) of VP 20629 for Multiple Dose Groups|The CLR,ss is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 8.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter per hour||Standard Deviation|Mean
15277|NCT01895309|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52|||percentage of participants|||Number
15109|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine at Steady State (Ae,ss) of Unchanged VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Ae,ss is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||microgram||Standard Deviation|Mean
15110|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||per hour||Standard Deviation|Mean
15111|NCT01898884|Secondary|Total Body Drug Clearance at Steady State (CLss/F) of VP 20629 for Multiple Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter per hour||Standard Deviation|Mean
15112|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Multiple Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter||Standard Deviation|Mean
15113|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||hour||Standard Deviation|Mean
15114|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCtau is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||h*ng/mL||Standard Deviation|Mean
15115|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, n is number of participants analyzed for this outcome measure at given time points."||h*ng/mL||Standard Deviation|Mean
15116|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCss is the area under the plasma concentration time curve observed during a dosing at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||h*ng/ml||Standard Deviation|Mean
15117|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||h*ng/ml||Standard Deviation|Mean
15118|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax,ss is the time to reach maximum observed plasma concentration at steady state of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||hour||Standard Deviation|Mean
15119|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||hour||Standard Deviation|Mean
15120|NCT01898884|Secondary|Maximum Observed Serum Concentration at Steady State (Cmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax,ss is the maximum observed plasma concentration at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||ng/mL||Standard Deviation|Mean
15278|NCT01895309|Secondary|ACR20||Week 52|||percentage of participants|||Number
15121|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax is the maximum observed plasma concentration of Multiple Dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
15122|NCT01898884|Secondary|Renal Clearance (CLR) of VP 20629 for Single Dose Groups|The CLR is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 1 or Ae(0-24)/AUC(0-24) on Day 1.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||liter per hour||Standard Deviation|Mean
15123|NCT01898884|Secondary|Percentage of Drug Excreted in Urine (Ae%) of VP 20629 for Single Dose Groups|The Ae% is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||percentage of dose||Standard Deviation|Mean
15124|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine (Ae) for Unchanged VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."||microgram (mcg)||Standard Deviation|Mean
15125|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||per hour||Standard Deviation|Mean
15126|NCT01898884|Secondary|Total Body Drug Clearance (CL/F) of VP 20629 for Single Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||liter per hour||Standard Deviation|Mean
15127|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Single Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||Liter||Standard Deviation|Mean
15128|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||hour||Full Range|Median
15129|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Plasma Concentration (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUCt is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||h*ng/mL||Standard Deviation|Mean
15130|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||h*ng/mL||Standard Deviation|Mean
15131|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
15132|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||hour||Standard Deviation|Mean
15133|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Cmax is the maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
15134|NCT01898884|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|ECG included PR interval, QRS interval, QTcB interval, QTcF interval were considered as clinically significant ECG abnormalities.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
15135|NCT01898884|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included systolic blood pressure, diastolic blood pressure, heart rate, and temperature. Vital signs abnormalities reported as TEAEs were reported.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
15136|NCT01898884|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 7 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with Grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
15137|NCT01898884|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs), defined as all AEs that start during study drug treatment (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during study drug treatment (and up to 7 days after the last dose of study drug).|From Start of Study Treatment up to Day 19|The ITT-safety (ITT-S) set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.||participants|||Number
15138|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (AUC0-t)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours|||ng*hr/mL||Full Range|Geometric Mean
15139|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Cmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours|||ng/mL||Full Range|Geometric Mean
15140|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Tmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours|||hours||Full Range|Geometric Mean
15141|NCT01898442|Secondary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points|Secondary outcomes included the comparison of the platelet reactivity index (PRI) determined by vasodilator-stimulated phosphoprotein (VASP) at 30 min and 1, 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 1, 2, 4, 8, 24 hours|||PRI||Standard Error|Least Squares Mean
15142|NCT01898442|Secondary|Platelet Reactivity by VerifyNow P2Y12 at Other Time Points|Secondary outcomes included the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 30 min and 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 2, 4, 8, 24 hours|||PRU||Standard Error|Least Squares Mean
15143|NCT01898442|Primary|Platelet Reactivity by VerifyNow P2Y12|The primary end-point of the study was the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 1 hour after administration|1 hour|||PRU||Standard Error|Least Squares Mean
15144|NCT01898286|Other Pre-specified|Glycemic Control (Change From Baseline in % HbA1c)||Baseline and Early Termination Visit, Up to 25 Months|All patients with % HbA1c data at baseline and their early termination visit. Only 5 patients were available for this analysis, as not all patients agreed to complete HbA1c testing at the early termination visit.||% HbA1c||Standard Deviation|Mean
15145|NCT01898286|Other Pre-specified|Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit||Baseline and Early Termination Visit, up to 25 months|All patients with daily insulin dose data at baseline and their early termination visit. Only 11 patients could be included in this analysis, as not all patients provided insulin dose data at their early termination visit.||IU/kg||Standard Deviation|Mean
15146|NCT01898286|Secondary|Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.|Baseline and Early Termination Visit, Up to 25 Months|Only 9 patients had sufficient data for this analysis, as many patients declined to undergo the GST at the termination visit.||nmol*minute/L||Standard Deviation|Mean
15279|NCT01895309|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24|||percentage of participants|||Number
15147|NCT01898286|Primary|Hypoglycemic Events|The number of hypoglycemic events recorded by each patient over the course of the study.|At Early Termination Visit, Up to 25 Months|Patients with hypoglycemic event data at the time of their early termination visit. This population is smaller than the population numbers in the patient flow categories because not all patients were willing to provide information on hypoglycemic events at early termination.||hypoglycemic events||Standard Deviation|Mean
15148|NCT01898208|Secondary|Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject|Costs were calculated using a standardized inflation-adjusted estimate of costs for each service or procedure performed in constant dollars. This approach adjusts for hospital-billed charges with Medicare Cost Report department-level cost-to-charge ratios. Physician services were proxied with Medicare reimbursement rates based on Current Procedure Terminology (CPT)-4 codes using the Medicare Fee Schedule. We did not include the cost of the stewardship program in the cost analysis, as it is not a billed service. As there was no Medicare reimbursement rate for the rmPCR test at the time of the study, test cost was proxied using the FilmArray respiratory panel. These costs were varied in sensitivity analysis with rmPCR test cost ranging from a 50% decrease to a 300% increase.|Approximately 7 days after positive blood culture and for duration of entire hospitalization|The number of subjects analyzed per arm is different than the number of subjects who completed the study because outpatients and a few subjects without final billing data available were excluded.||dollars||Standard Deviation|Mean
15149|NCT01898208|Secondary|Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment||Approximately within 72 hours of positive blood culture|||percentage of participants|||Number
15150|NCT01898208|Secondary|Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events|This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.|Approximately 14 days after positive blood culture|||participants|||Number
15151|NCT01898208|Secondary|All-cause and Attributable Mortality|If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.|30 days after positive blood culture|||participants|||Number
15152|NCT01898208|Secondary|Length of Entire Hospitalization (Days)||Participants were followed for the duration of hospital stay, approximately 15 days|||days||Inter-Quartile Range|Median
15153|NCT01898208|Other Pre-specified|Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment|Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.|Approximately 30 days after positive blood culture|||percentage of participants|||Number
15154|NCT01898208|Other Pre-specified|Length of Intensive Care Unit Stay||within 14 days of positive blood culture until ICU discharge|||days||Inter-Quartile Range|Median
15155|NCT01898208|Secondary|Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment||3 Days after enrollment|||participants|||Number
15156|NCT01898208|Secondary|Time to Pathogen Identification||Approximately 14 days after positive blood culture|The number of subjects analyzed per arm differs from the number of subjects who completed the study because this outcome measure includes only the subset of subjects who had organisms represented on the rapid multiplex PCR (rmPCR) panel.||hours||Inter-Quartile Range|Median
15157|NCT01898208|Secondary|Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours|Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.|Within 14 days after positive blood culture|||Percentage of blood cultures|||Number
15158|NCT01898208|Secondary|Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics|De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic.|Positive Gram stain, 96 hours after enrollment|Not all subjects experienced de-escalation or escalation of their antibiotics. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship).||hours||Inter-Quartile Range|Median
15159|NCT01898208|Secondary|Time From Positive Gram Stain to First Active Antibiotic|From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.|Approximately 14 days after positive blood culture|Not all subjects were not on active therapy at enrollment, and also subjects with contaminated blood cultures were excluded. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship): (n=45, 41, 37)||hours||Inter-Quartile Range|Median
15160|NCT01898208|Primary|Duration of Antimicrobial Therapy (Hours)|Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.|Approximately 4 days after enrollment|Subjects could have received more than one antimicrobial. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship)||hours||Inter-Quartile Range|Median
15161|NCT01897727|Primary|Severity of Obstructive Sleep Apnea|3 month change in apnea-hypopnea index assessed by diagnostic, full-night polysomnography. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe.|baseline and 3 months|||events/hour||Standard Deviation|Mean
15162|NCT01897402|Secondary|Non Solicited Adverse Events|Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.|up to 6 months|Safety Population: All vaccinated participants, grouped by actual vaccine received.||participants|||Number
15163|NCT01897402|Secondary|Solicited Adverse Events From Diary Cards|Local and systemic rates from Diary Cards filled by the participants.|Day 0 to Day 7 after vaccination|Safety Population: All vaccinated participants, grouped by actual vaccine received.||percentage of participants|||Number
16746|NCT01849770|Secondary|Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication|||ratio||95% Confidence Interval|Number
15164|NCT01897402|Primary|Seroresponse (Percent Seroconversion).|Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a 4-fold rise in antibody levels.|Week 4 after injection|Per Protocol Population||percentage of per protocol participants||95% Confidence Interval|Number
15165|NCT01897285|Secondary|Safety - the Nature and Frequency of Adverse Events|"Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded.~Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction."|7 days|||participants|||Number
15166|NCT01897285|Primary|Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)|"Adhesion at 7 days measured by:~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Conformability~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Dressing Integrity~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Ease of Application~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Ease of Removal,~1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult~Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable~Comfort during removal~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)"|7 days|20/20 subjects completed maximum study participation of 7 days. Two subjects dressings detached very early on so returned for their final evaluation on the second day. The final subject status was recorded as ‘other’ for these two subjects. Many dressings detached when volunteers were away from the clinic and prior to returning for the assessments.||participants|||Number
15167|NCT01897233|Secondary|Part B: Pre-dose Concentration (Ctrough) and 3 to 6 Hours Post-dose Concentration (C3-6hr) of Lumacaftor, Lumacaftor Metabolite (M28-LUM), Ivacaftor and Ivacaftor Metabolites (M1-IVA and M6-IVA)|Ctrough and C3-6hr for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. Ctrough was observed pre-dose concentration. C3-6hr was observed concentration at 3 to 6 hours post- dose.|For Ctrough: pre-morning dose on Week 4, Week 6 and Week 24; For C3-6hr: 3 to 6 hours post-morning dose on Day 1, 15 and Week 4|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable. Here “n” signifies those participants who were evaluable at the specified time point for the given category.||ng/mL||Standard Deviation|Mean
15168|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domains at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||units on a scale||95% Confidence Interval|Least Squares Mean
15169|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||Units on a scale||95% Confidence Interval|Least Squares Mean
15170|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score (height z-score). The height-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||z-score||95% Confidence Interval|Least Squares Mean
15171|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||centimeter (cm)||95% Confidence Interval|Least Squares Mean
15172|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (weight z-score). The weight-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||z-score||95% Confidence Interval|Least Squares Mean
15173|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
16014|NCT01871532|Secondary|Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
15174|NCT01897233|Secondary|Part B: Absolute Change From Baseline in BMI-for-age Z-score at Week 24|BMI was defined as weight in kg divided by height*height in m^2. z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score). The BMI-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||z-score||95% Confidence Interval|Least Squares Mean
15175|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
15176|NCT01897233|Secondary|Part B: Absolute Change in Sweat Chloride From Week 24 at Week 26|Sweat samples were collected using an approved collection device. Change = Week 26 minus Week 24.|Week 24, Week 26|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||mmol/L||95% Confidence Interval|Least Squares Mean
15177|NCT01897233|Secondary|Part B: Average Absolute Change From Baseline in Sweat Chloride at Day 15 and at Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. Average of Day 15 and Week 4 measurements was taken and change was calculated as: Average (Day 15 and Week 4 measurement) minus Baseline measurement.|Baseline, Day 15 and Week 4|The Full Analysis Set (FAS) included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
15178|NCT01897233|Secondary|Part A: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose through the end of Part A were considered treatment-emergent.|Day 1 up to Day 28|The Safety Set included all participants who received at least 1 dose of study drug. Here “n” signifies those subjects who were evaluable for the specified cohort.||participants|||Number
15179|NCT01897233|Secondary|Part A: Observed Plasma Concentration of Lumacaftor Metabolite (M28-LUM) and Ivacaftor Metabolites (M1-IVA and M6-IVA) at Hour 4 Post-dose (C4h) on Day 1 and 14||Day 1 (pre-dose, 2, 4, 6 and 12 hours post-morning dose); Day 14 (pre-dose, 4, 6, 12, and anytime between 24 to 96 hours post-morning dose)|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||ng/mL||Standard Deviation|Mean
15180|NCT01897233|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose to Week 26 were considered treatment-emergent.|Day 1 up to Week 26|The Safety Set included all participants who received any amount of Part B study drug||participants|||Number
15181|NCT01897233|Primary|Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA)|The AUCtau is the area under the concentration versus time curve from time 0 to time tau, where tau is the time at the end of dosing interval.|Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||ng*hr/mL||Full Range|Median
15182|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14||4 hours post-morning dose on Day 14|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||ng/mL||Standard Deviation|Mean
15183|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1||4 hours post-morning dose on Day 1|The Pharmacokinetic (PK) Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
15184|NCT01897025|Secondary|MRI Parameters|active and passive fMRI, DTI, This part of data is still under analyzing.|-2, 0 and 4 weeks||12/2015||||
15185|NCT01897025|Secondary|Box and Block Test|Box and block test was to measure the gross manual dexterity. This part of data is still under analyzing.|pre and post training, and 4 weeks post training||12/2015||||
15186|NCT01897025|Secondary|Grip Strength|Grip strength was measured using a hand-held dynamometer. This part of data is still under analyzing.|pre- and post-training, and again at 4 weeks post-training||12/2015||||
15187|NCT01897025|Secondary|Resting Motor Threshold of Stroke Affected M1 Motor Cortex|"Resting motor threshold (RMT) is defined as the percentage of maximum stimulator output required to elicit motor evoked potential (MEP) with 50 µV peak-to-peak amplitude in at least 4 out of 8 trials during single-pulse transcranial magnetic stimulation (TMS).~Short intra-cortical inhibition (SICI) and intracortical facilitation (ICF) were measured using paired pulse stimulation with an initial conditioning stimulus of 80% of RMT and a test stimulus of 120% of RMT. MEPs were recorded at inter-stimulus intervals (ISIs) of 2, 4, 6, 10 and 15 ms. ISIs of 1-3 ms typically induce SICI while ISIs of 10-15ms typically reflect ICF.~This part of data is still under analyzing."|pre- and post-training, 4 weeks post-training||12/2015||||
15188|NCT01897025|Primary|Upper Extremity Component of Fugl-Meyer Assessment|The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).|week 0, week 2, week 4|Subjects aged 21 to 70 years who had their first-ever subcortical stroke at least 9 months before recruitment, with moderate to severe impairment of upper extremity function (subscore of the Fugl-Meyer Motor Assessment [FMMA], 11-45), were recruited.||units on a scale||Standard Deviation|Mean
15189|NCT01896687|Primary|Worst Low Back Pain Score|"Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from 0 meaning no pain to 10 meaning pain as bad as you can imagine."|baseline to 3 weeks post-treatment|||units on a scale||Standard Deviation|Mean
15190|NCT01896557|Other Pre-specified|Comparing the Main Outcome on Pre-specified Subgroups|"The main outcome will be compared on pre-specified subgroups:~elderly (age > 65 yrs-old) versus non-elderly~male versus female~smoking versus non-smoking patients~obese (BMI > 30 kg/m2) versus non-obese~diabetic versus non-diabetic~patients in use or not in use of statins~presence or not of genetic polymorphisms on cytochrome 2C19."|1 week after drug exposure||||||
15191|NCT01896557|Secondary|Comparison of the Primary Outcome With Other Two Methods of Platelet Aggregability: PFA-100 and Bioimpedance Aggregometry|After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by two other methods: PFA-100 (Siemens-USA) and bioimpedance aggregometry.|1 week after drug exposure||||||
15192|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as Observed Platelet aggregability - Platelet aggregability at baseline divided by Platelet aggregability at baseline.|One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline|||Inhibition of Platelet Aggregation||Standard Deviation|Mean
15193|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units.|One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline|||P2Y12 Reactivity Units||Standard Deviation|Mean
15194|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum hsCRP.|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days|||mg/L||Inter-Quartile Range|Median
15195|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|"Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of:~1) 30 day hospital readmission; and 2) 30 day mortality."|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days|||participants|||Number
15196|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of: 1) ICU length of stay; and 2) hospital length of stay|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days|||days||Inter-Quartile Range|Mean
15197|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum LL-37.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days|||ng/mL||Inter-Quartile Range|Median
15226|NCT01896115|Other Pre-specified|Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering|Resting tremor was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and current steering settings, at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming Visit|||units on a scale||Standard Deviation|Mean
15198|NCT01896544|Primary|Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibroblast growth factor 23; 5) Vitamin D binding protein; 6) LL-37; 7) Parathyroid hormone; 8) Albumin; 9) Calcium; and 10) Phosphorus levels.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days|||ng/mL||Inter-Quartile Range|Median
15199|NCT01896297|Primary|Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose|Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)|2 hours after the last drug administration, on day 8|PKS. Analysis includes patients with available data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
15200|NCT01896297|Primary|Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).|Immediately before the last drug administration, on day 8|Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
15201|NCT01896206|Primary|The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.|To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.|Participants will be followed for the duration of surgery, an expected average of 2 hours.|The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.||mmHg||Standard Deviation|Mean
15202|NCT01896193|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
15203|NCT01896193|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
15204|NCT01896193|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
15205|NCT01896193|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
15206|NCT01896193|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug||percentage of participants|||Number
15207|NCT01895101|Secondary|Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)|The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.|participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks|||IU||Standard Deviation|Mean
15208|NCT01895101|Secondary|Number of Participants Requiring Surgical Re-exploration|the secondary objective of this study is to determine whether pericardial lavage with saline gives an improvement in haemostasis, compared with no pericardial lavage, resulting in a reduction of surgical re-explorations and post-operative 12-hour blood loss. The choice for a surgical re-exploration will be decided according to the ICU protocol.|participants will be followed for the duration of ICU stay, an expected average of 2 days|||participants|||Number
15209|NCT01895101|Primary|Postoperative Blood Loss|The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure|12 hours postoperative|||ml||Inter-Quartile Range|Median
15210|NCT01895062|Secondary|The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.|interventions such as reduction of sedative medication or jaw thrust.|1 hour|||interventions to restore airway|||Number
15211|NCT01895062|Secondary|The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.||1 hour||||||
15212|NCT01895062|Secondary|The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.||1 hour||||||
15213|NCT01895062|Primary|RI Events in the cNEP Group Compared to the no cNEP Group, Where RI is Defined as Either: i Oxygen Saturation < 90% or ii. Apneas/Hypopneas of > 15 Sec Duration i. Oxygen Saturation <90% ii. Presence of Apneas or Hypopneas|Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)|1 hour|Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several.||RI events||95% Confidence Interval|Mean
15214|NCT01894984|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment|Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation.|Month 6|Analysis population included all enrolled participants.||Participants|||Number
41610|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban Acylglucuronide After Three Days of 15 mg IV Daily in HRS Type 1 Patients||3 days|||hr||Standard Deviation|Mean
15215|NCT01894984|Secondary|Percentage of Participants Attaining Remission Criteria|Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual’s behavior.|Month 6|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||Percentage of Participants|||Number
15216|NCT01894984|Secondary|Percentage of Participants With Relapse at Week 24|Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition.|Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||Percentage of Participants|||Number
15217|NCT01894984|Secondary|Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||units on a scale||Standard Deviation|Mean
15218|NCT01894984|Secondary|Total Personal and Social Performance (PSP) Score|The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||units on a scale||Standard Deviation|Mean
15219|NCT01894984|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 24|Intent to treat (ITT) population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.||units on a scale||Standard Deviation|Mean
15220|NCT01894906|Secondary|Dialysate OutFlow Iron Concentration|Dialysate outflow iron concentration was calculated for each treatment group at t = 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||micrograms/L||Standard Deviation|Mean
15221|NCT01894906|Secondary|Dialysate InFlow Iron Concentration|Dialysate inflow iron concentration was calculated for each treatment group at t = 0, 0.5, 1, 2, 3, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||micrograms/L||Standard Deviation|Mean
15222|NCT01894906|Primary|Net Iron Delivery From SFP Via the Dialysate|To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||microgram||Standard Deviation|Mean
15223|NCT01894906|Secondary|Pharmacokinetics of Serum Iron and Exploratory Modeling|The serum Total Iron, Transferrin Bound Iron (TBI) and Non-transferrin Bound Iron (NTBI) pharmacokinetic parameters (baseline corrected and total) will be listed and summarized for each membrane group and overall. The mean serum total iron, TBI, NTBI, unsaturation iron binding capacity (UIBC) and total iron binding capacity (TIBC) concentrations at baseline (BL), end-of-treatment, and the change from BL will be listed for each group (Baxter and Gambro Polyflux), measured from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate).|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||microgram/dL||Standard Deviation|Mean
15224|NCT01894906|Secondary|To Compare the Amount of SFP-derived Iron Administered Under Various Treatment Conditions to the Reference HD|To compare the amount of SFP-derived iron administered under various treatment conditions to the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate): Dialyzer reuse, Low machine bicarbonate delivery, Polyarylethersulfone (PAES) membrane, and Low Qb/Qd.Iron concentration in timed dialysate collections will be analyzed. Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.||microgram||Standard Deviation|Mean
15225|NCT01896115|Other Pre-specified|Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and dorsal and ventral current steering settings. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|||units on a scale||Standard Deviation|Mean
20562|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
15227|NCT01896115|Other Pre-specified|Dorsal-Ventral Current Steering Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, this measure reports the stimulus amplitude difference between the full rigidity control threshold and the first stimulation induced side effect threshold at current steering settings (current divided 50% between adjacent electrodes).|Day 1 programming visit|The therapeutic window of short pulse widths vs. conventional pulse widths was a primary outcome measure and is reported as such in another section of this report.||mA||Standard Deviation|Mean
15228|NCT01896115|Secondary|Finger Tapping Amplitude - Single Contact vs. Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).||units on a scale||Standard Deviation|Mean
15229|NCT01896115|Secondary|Resting Tremor Severity - Single Contact vs. Steering|Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).||units on a scale||Standard Deviation|Mean
15230|NCT01896115|Secondary|Side Effect Thresholds - Single Contact vs. Steering|This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths. Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).||mA||Standard Deviation|Mean
15231|NCT01896115|Primary|Unified Parkinson's Disease Rating Scale III|"The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings.~The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108."|Day 1 programming visit|All subjects were analyzed at both pulse widths. Primary outcomes were only intended to be assessed for different pulse widths and not current steering.||UPDRS III score||Standard Deviation|Mean
15232|NCT01896115|Primary|Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.|Day 1 programming visit|"Therapeutic window for current steering settings was not a primary outcome measure but is described later as an Other outcome measure."||mA||Standard Deviation|Mean
15233|NCT01896050|Secondary|Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months|Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment|baseline and 12 months|||participants|||Number
15234|NCT01896050|Secondary|Effect of Medication on Change in Grip Strength|Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months|baseline and 12 months|||percent change||Standard Deviation|Mean
15235|NCT01896050|Primary|Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy|Change in BMI between baseline and 12 months of endocrine therapy|baseline and 12 months|These data only include patients who completed a full 12 months of treatment with either an aromatase inhibitor or tamoxifen and had grip strength data at both baseline and 12 months. Patients could have switched from one aromatase inhibitor to another. Those patients who discontinued treatment prior to the 12 month period were excluded.||kg/m^2||Standard Deviation|Mean
15236|NCT01895946|Secondary|Efficacy: Progression-free Survival (PFS)|PFS is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression. Subjects who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||weeks||Inter-Quartile Range|Median
15237|NCT01895946|Secondary|Efficacy: Target Lesion Size, Best Percentage Change From Baseline|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.~best percentage change in tumour size from baseline is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction from baseline based on all post baseline assessments."|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Percentage change from baseline||Standard Deviation|Mean
15238|NCT01895946|Secondary|Efficacy: Target Lesion Size, Percentage Change From Baseline at Week 12|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.~The percentage change in target lesion tumour size at each week 12 for which data are available was obtained for each subject taking the difference between the sum of the target lesion at each week 12 and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline multiplied by 100 (i.e. (week 12) - baseline)/baseline * 100)."|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Percentage change from baseline||Standard Deviation|Mean
15239|NCT01895946|Secondary|Efficacy: Disease Control at Week 12|Disease control = confirmed complete response + confirmed partial response + stable disease at 12 weeks|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Participants|||Number
15240|NCT01895946|Secondary|Efficacy: Best Objective Response (BOR)|"Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines for measurable, non-measurable, target lesions (TLs) and non-target lesions (NTLs) and the objective tumour response criteria was used.~Categorisation of objective tumour response assessment was based on the RECIST 1.1 guidelines for response: CR (complete response, efined as disappearance of all target lesions), PR (partial response, defined as >=30% decrease in the sum of the longest diameter of target lesions), SD (stable disease, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) and PD (progression of disease, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion). BOR was the best overall response observed across the study and up to 36 weeks. Number of subjects with response (CR or PR) is described."|Assessed every 6 weeks, up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.||Participants|||Number
15241|NCT01895946|Primary|Ratio of AUCss for Day 4 to Day 11|"The actual sampling times were used in the parameter calculations and PK parameters were derived using standard non-compartmental methods.~Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:~Css max, tss max, Css min, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and CLss/F.~Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.~Ratio of AUCss for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.||Ratio||90% Confidence Interval|Geometric Mean
15242|NCT01895946|Primary|Ratio of Css,Max for Day 4 to Day 11|"The actual sampling times were used in the pharmacokinetics (PK) parameter calculations and PK parameters were derived using standard non-compartmental methods.~Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:~Maximum plasma concentration at steady state (Css max), time to Css,max (tss max), minimum plasma concentration at steady state (Css min), area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and apparent clearance (CLss/F).~Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.~Ratio of Css,max for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.||Ratio||90% Confidence Interval|Geometric Mean
15243|NCT01895634|Secondary|All Cause Mortality||90 days post-procedure|||participants|||Number
15244|NCT01895634|Secondary|Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)||24-hour post procedure|Missing value was not be imputed (1 missing subject was because of the death within 24 hours)||participants|||Number
15245|NCT01895634|Secondary|Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure|"The Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death, or similar, as accurate."|90 days post procedure|Missing value was not be imputed (1 missing subject was because of the missing data at 90 days by subject IC withdrawal)||participants|||Number
15246|NCT01895634|Secondary|Proportion of Subject Who Have Clot Migration/Embolization||immediately post procedure|||participants|||Number
15247|NCT01895634|Primary|Proportion of Patients Who Have Recanalization|Proportion of subjects who had recanalization, TICI 2a or better|immediately post procedure|||participants|||Number
15248|NCT01895543|Secondary|Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score|"The EQ VAS presents the participant's self-evaluated health on a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. This scale is numbered from 0 to 100, where '100' means best health you can imagine and '0' means worst health you can imagine. The participant simply mark an 'X' on the scale to indicate how his/her health is TODAY and mention the same number in a box provided."|At Week 12, 24, 36 and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
15249|NCT01895543|Secondary|Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores|EQ-5D-5L is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels (1-5 denotes): no problems, slight problems, moderate problems, severe problems, and extreme problems, respectively. A unique health state was defined by combining 1 level from each of the 5 dimensions. Each health state was converted into a single EQ-5D-5L index value. The index values are country specific and values specified for United Kingdom (UK) were used for this study. The index value range for UK lies between -0.594 - 1.000. A positive index value represents better health status while the negative value represents poor health status.|At Week 12, 24, 36 and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
15251|NCT01895543|Secondary|Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score|PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific QOL. The questionnaire is based on a 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better QOL. The PAC-QOL questionnaire is developed specifically for patients with constipation. PAC-QOL has four sub-scales: ‘Worries and Concerns’, ‘Physical Discomfort’, ‘Psychosocial Discomfort’, and ‘Dissatisfaction’.|At Week 12, 24, 36 and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
15252|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Treatment Effectiveness|The treatment effectiveness score was measured on a 5-point scale (1: extremely effective, 2: quite a bit effective, 3: moderately effective, 4: little bit effective, 5: not at all effective).|At Week 12, 24, 36, and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
15253|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Constipation Severity|The constipation severity score was measured on a 5-point scale (1: none to 5: very severe).|At Week 12, 24, 36, and 52|Safety Analysis Set||Unit on a scale||Standard Deviation|Mean
15254|NCT01895543|Secondary|Use of Concomitant Over-the-counter (OTC) Laxatives|The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF).|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
15255|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs|Vital signs were measured at all visits and included blood pressure (BP: measured after the patient had been in a seated position for ≥3 minutes of rest), pulse, respiration rate, body temperature, and body weight.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
15256|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs)|A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
15257|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables|Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
15258|NCT01895543|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)|The Investigator recorded all AEs throughout the trial from the time of obtaining informed consent till the last visit (i.e., Visit 6). Information on AE was collected at each visit. All AEs were recorded in AE log for each patient.|For the overall 52-week Treatment Period|Safety Analysis Set||Patients|||Number
15259|NCT01895335|Secondary|Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48|EDSS is a method of quantifying disability in MS participants and monitoring changes in the level of disability over time. EDSS quantifies disability in 8 functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. EDSS scale ranges from 0 to 10 in 0.5 unit increments that represents higher levels of disability. EDSS score 1.0 to 4.5 refers to people with MS who are fully ambulatory; EDSS score 5.0 to 9.5 refers to impairment to ambulation; EDSS score 10 refers to death due to MS.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
15260|NCT01895335|Secondary|Change From Baseline in Stern Leisure Activity Scale at Week 48|The Stern Leisure Activity Scale is a self-reported scale that consists of 13 questions assessing the participant’s participation in leisure activities during the preceding month. One point is given for participation in each of the 13 activities and an aggregate score (range from 0 to 13) is obtained. ≤ 6 score is considered as low leisure activity and > 6 score as high leisure activity.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
15261|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48|The MusiQoL is a quality of life questionnaire that consists of 31 questions, divided into 9 dimensions: activities of daily living, physiological well-being, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping, rejection and relationship with healthcare system. All the 9 dimension scores and the global scores are linearly transformed and standardized on 0 (worst outcome) -100 (best outcome) scale. Higher scores represents higher quality of life.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
15262|NCT01895335|Secondary|Duration of Teriflunomide Treatment Exposure|Duration of exposure was defined as last dose date – first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.||Days||Standard Deviation|Mean
15263|NCT01895335|Secondary|Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period|Percentage of compliance for a participant was defined as the number of days that the participant was compliant (1 tablet/day) divided by the exposure duration in days (from the first dose administration to the last dose administration) times 100.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.||percentage of participants|||Number
15264|NCT01895335|Secondary|Overview of Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during from first study drug intake up to 112 days after last intake for participant with no accelerated elimination procedure (AEP) or to last AEP follow up visit for participants with AEP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP|Safety Population that included all treated participants who received at least 1 dose or part of a dose of IMP.||percentage of participants|||Number
15265|NCT01895335|Secondary|Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48|SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The score is computed as a ratio of number of correct responses divided by the total number of responses. The test score range from 0 (worst outcome) to 1 (best outcome). Higher scores are indicative of better cognition function.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
15266|NCT01895335|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48|A treated relapse was defined as a relapse treated by a systemic corticosteroid treatment or by another DMT. If a participant had no treated relapse before treatment discontinuation/completion, then the participant was considered as free of treated relapse until the date of treatment discontinuation/completion. Only treated relapse occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. Kaplan-Meier method was used to estimate the probability of treated MS relapse at 4, 24 and 48 weeks.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.||percent probability of treated relapse||95% Confidence Interval|Number
15267|NCT01895335|Secondary|Annualized Treated Relapse Rate|Annualized treated relapse rate was defined as the total number of treated relapses during the study treatment period divided by the total number participants-years of treatment. Only events occurred during the treatment period (first drug administration to last drug administration) were considered for analysis.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.||relapses per patient-year|||Number
15268|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48|MSPS was a self-reported measure for MS associated disability in which participants were asked to indicate the category that best described their condition during the past month on the following 8 subscales: mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms and spasticity symptoms. MSPS used a single question to assess each of 8 subscales. All of the subscales ranged from 0= normal to 5= total disability, except mobility subscale which ranged from 0= normal to 6=total disability. Total MSPS score ranged from 0 =normal to 41=greater disability, where higher score reflected greater disability.|Baseline, Week 24, Week 48|Analysis was performed on Efficacy population. Here, ‘n’ signifies number of participants with available data at specified time points.||units on a scale||Standard Deviation|Mean
15269|NCT01895335|Secondary|Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48|PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale consists of 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
15270|NCT01895335|Secondary|Change From Week 4 in TSQM Scores in Naïve Participants to Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction.|Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
15271|NCT01895335|Secondary|Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .|Baseline, Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
15272|NCT01895335|Primary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 – Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48|"TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14).~Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Week 48|Efficacy population that included all treated participants. Number of participants analyzed = participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
15273|NCT01895322|Secondary|Percent Change in Body Weight|Percent change in body weight from baseline during the repeated-administration period(For five days).|100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>|||Percentage||Standard Deviation|Mean
15274|NCT01895322|Primary|Percent Change in Daily Urine Volume From Baseline|Percent change in daily urine volume from baseline during the repeated-administration period (For five days).|100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>|||Percentage||Standard Deviation|Mean
15275|NCT01895322|Secondary|Change in Body Weight From Baseline|Change in body weight from baseline during the repeated-administration period(For five days).|Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period|||kg||Standard Deviation|Mean
15281|NCT01894607|Primary|Successful Capture of IO-CEUS Images|Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.|1 day|1 participant was ineligible.||participants|||Number
15282|NCT01894581|Primary|Change in the Average LH Pulse Amplitude|To test the pituitary and hypothalamic output, we examined LH secretion (unstimulated and in response to gonadotropin-releasing hormone (GnRH) stimulation) during 8-hour blood sampling studies at 10 min intervals. The primary outcome measure is the change in the average LH pulse amplitude for each patient from baseline to after supplementation.|10 minute intervals during 8 hour blood sampling studies. Subjects will undergo two menstrual cycles of study, one prior to dietary supplementation and one after supplementation.|||IU/L||Standard Deviation|Mean
15283|NCT01894555|Primary|Changes in Platelet Transcriptome|"Comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after aspirin therapy.~The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area"|4 weeks|The data were analyzed combining results from two studies (33 from this study and additional 24 individuals from study NCT02234427; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.||FPKM difference for HBG1 Gene||Standard Error|Mean
15284|NCT01894256|Other Pre-specified|CL/F of Unbound Olaparib|Calculated from dose divided by free AUC|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L/hour||Standard Deviation|Median
15285|NCT01894256|Other Pre-specified|Free AUC of Olaparib|AUC of unbound olaparib; calculated by multiplying total AUC by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
15286|NCT01894256|Other Pre-specified|Free Cmax of Olaparib|Cmax of unbound olaparib; calculated by multiplying total Cmax value by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
15287|NCT01894256|Other Pre-specified|Protein Binding of Olaparib|Degree to which olaparib binds to the proteins within blood plasma|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||% plasma||Standard Deviation|Mean
15288|NCT01894256|Primary|t1/2 of Olaparib|Terminal half-life of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||Hours||Standard Deviation|Mean
15289|NCT01894256|Primary|CLR of Olaparib|Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24|Part A: Day 1, 0-12 hours and 12-24 hours post-dose|"Subset of PK analysis set with urine samples available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L/hour||Standard Deviation|Mean
15290|NCT01894256|Primary|CL/F of Olaparib|Apparent plasma clearance of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L/hour||Standard Deviation|Mean
15291|NCT01894256|Primary|Vz/F of Olaparib|Apparent volume of distribution of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||L||Standard Deviation|Mean
15292|NCT01894256|Primary|Tmax of Olaparib|Time to reach maximum plasma concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||Hours||Full Range|Median
15293|NCT01894256|Primary|AUC0-t of Olaparib|Area under plasma concentration-time curve from zero to the last measurable time point of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
15294|NCT01894256|Primary|AUC of Olaparib|Area under plasma concentration-time curve from zero to infinity of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
15417|NCT01890148|Primary|Summary for Change From Baseline Neutrophil Cell Counts in Blood|Change from Baseline reflects the Day 2, Day 8, Day 15, Day 22, Day29 and Day 34 minus the baseline value|Baseline, Day 2, Day 8, Day 15, Day 22, Day29 and Day 34|PD Analysis||10^9 cells/L||Standard Deviation|Mean
15295|NCT01894256|Primary|Cmax of Olaparib|Maximum plasma drug concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
15296|NCT01894100|Secondary|Change in Lower Extremity Physical Function|"For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale~For performance based lower extremity physical function: Short Physical Performance Battery"|Baseline and 3 and 6 months post intervention|||units on WOMAC function scale; 3 months||Standard Deviation|Mean
15297|NCT01894100|Primary|Change in Pain Intensity|Western Ontario and McMasters Universities Osteoarthritis Index pain subscale|Baseline and 3 and 6 months after initiating intervention|||units on a scale; at 3 months||Standard Deviation|Mean
15298|NCT01893567|Secondary|Subject Reported Effectiveness Scores||2 weeks||||||
15299|NCT01893567|Secondary|Investigator Reported Effectiveness Scores||2 weeks||||||
15300|NCT01893567|Primary|Subject Reported Target Lesion Severity Score.|Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.|2 weeks|||units on a scale||Standard Deviation|Mean
15301|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to twelve months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted.|||||
15302|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to six months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted. Data for MSRE were collected for the two treated patients the primary endpoint is a comparison between the treatment groups. The two patients were in the same treatment group so a comparison between groups is not possible.|||||
15303|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax|Key PK parameters are shown for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
15304|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC|Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
15305|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level|"PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was very much better, a score of 4 indicated that the participant had experienced no change in energy level and a score of 7 indicated that the participant's energy level was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) * 100."|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I energy level questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for energy level collected from Day 15 through end of study.||percentage of participants|||Number
15306|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive|PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was “very much better,” a score of 4 indicated that the participant had experienced “no change” in sexual drive and a score of 7 indicated that the participant's sexual drive was “very much worse”. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) * 100.|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I sexual drive questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for sexual drive collected from Day 15 through end of study.||percentage of participants|||Number
15307|NCT01893281|Secondary|Change From Baseline in Serum Testosterone Levels|Serum testosterone levels were measured by LC/MS-MS.|Baseline, Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug with non-missing data at baseline and at least 1 post baseline measurement. Last-observation-carried-forward (LOCF) was used to impute missing data.||ng/dL||Standard Deviation|Mean
15308|NCT01893281|Primary|Percentage of Participants Achieving Normal Serum Testosterone Levels|Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) * 100.|Baseline through Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement.||percentage of participants||95% Confidence Interval|Number
41611|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban After Three Days of 15 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
15309|NCT01893203|Other Pre-specified|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.|1 week|One week after the first photodynamic therapy (PDT), seven patients had more severe reactions (erythema, crusting) at the site treated with BF-200 ALA, five patients had more severe reactions at the MAL site and one patient showed no difference between sites.||participants|||Number
15310|NCT01893203|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|3 months|||percentage of complete clearance|Participants|95% Confidence Interval|Number
15311|NCT01893203|Secondary|Pain|"Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.~(treatment day). Of these values, the mean maximal pain is assessed."|12 hours|Patients||units on a scale||Full Range|Mean
15312|NCT01893203|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|0 (baseline) and 3 months|Punch biopsies bilaterally on treatment fields||percentage of complete clearance|||Number
15313|NCT01892657|Primary|Area of Erythema and Elevated Responses of Skin to Product|Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.|3 consecutive weeks|||participants|||Number
15314|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
15315|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute).|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
15316|NCT01892189|Secondary|Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
15317|NCT01892189|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
15318|NCT01892189|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 M-I||Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
15319|NCT01892189|Secondary|Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.||hours||Full Range|Median
15320|NCT01892189|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I)||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The pharmacokinetic (PK) analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
15321|NCT01892189|Primary|Ketamine-Induced Brain Activity in Regions of Interest During Resting State|Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32.|Day 1: 4 hours post TAK-063 dose or placebo|The pharmacodynamic (PD) analysis set included all participants in the safety set and with at least 1 valid PD assessment. PD analysis set did not include 2 participants treated with TAK-063 300 mg.||percent signal change in brain activity||Standard Deviation|Mean
15322|NCT01892020|Secondary|Incidence of AEs (Adverse Event)|Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.||Events/100 years of patient exposure|||Number
15418|NCT01890148|Primary|Summary for Change From Baseline Neutrophils in Sputum|Change from Baseline reflects the Day 8, Day22 and Day29 minus the baseline value.|Baseline, Day 8, Day 22 and Day29|PD analysis set||10^9 cells/L||Standard Deviation|Mean
15323|NCT01892020|Secondary|Incidence of Hypoglycemic Episodes|Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.||events per patient per year|||Number
15324|NCT01892020|Secondary|The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile|Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Four (4) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||mmol/L||Standard Error|Least Squares Mean
15325|NCT01892020|Secondary|2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile|PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Subjects were excluded from analysis due to lack of post-randomization measurements. See table.||mmol/L||Standard Error|Least Squares Mean
15326|NCT01892020|Secondary|­IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test|AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||min*mmol/L||Standard Deviation|Mean
15327|NCT01892020|Secondary|­1-hour PPG Increment Following a Standard Meal Test|The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 8 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||mmol/L||Standard Deviation|Mean
15328|NCT01892020|Primary|2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test|The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.||mmol/L||Standard Deviation|Mean
15329|NCT01891734|Secondary|Client Satisfaction Questionnaire (CSQ-8)|The 8-item Client Satisfaction Questionnaire (CSQ-8) is rated on an 8-32 scale. Higher scores represent greater satisfaction with the intervention.|6 weeks|||units on a scale||Standard Deviation|Mean
15330|NCT01891734|Secondary|Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score|The 12-item Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score is rated on a 0-100 scale. Higher scores represent better mental health functioning.|6 weeks, 12 weeks|These data include all participants who completed the 6-week follow-up assessment. Two participants from the PST-MF group did not complete the 6-week follow-up.||units on a scale||Standard Deviation|Mean
15331|NCT01891734|Primary|Depression Anxiety and Stress Scale (DASS)|The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse depression symptoms. The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse anxiety symptoms. The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse stress symptoms.|6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
15332|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.||hour||Full Range|Median
15333|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.||hour||Full Range|Median
15334|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.||hour||Full Range|Median
15335|NCT01891669|Secondary|Overall Survival|Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.|Baseline to death|All enrolled participants||pariticpants|||Number
15361|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 (G3) or Grade 4 (G4) from their baseline grade are presented. Hematology parameters included only lab tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||Participants|||Number
15336|NCT01891669|Secondary|Objective Response|Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment||pariticpants|||Number
15337|NCT01891669|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment||pariticpants|||Number
15338|NCT01891669|Secondary|Number of Participants With Positive Anti-PF-06263507 Antibody|The number of participants with positive anti-PF-06263507 antibody.|Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication|All enrolled participants who received at least one dose of study medication.||Participants|||Number
15339|NCT01891669|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.|All enrolled participants who received at least one dose of study medication.||Participants|||Number
15340|NCT01891669|Secondary|Number of Participants With Abnormalities in Urine Protein in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.|Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.||Participants|||Number
15341|NCT01891669|Secondary|Number of Participants With Chemistry Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.||Participants|||Number
15342|NCT01891669|Secondary|Number of Participants With Hematological Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.||Participants|||Number
15343|NCT01891669|Secondary|Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.||participants|||Number
15344|NCT01891669|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.||participants|||Number
15345|NCT01891669|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline up to Cycle 2 Day 1 (22 days)|All enrolled participants who received at least one dose of study medication.||Participants|||Number
15346|NCT01890954|Primary|Percent of Time Spent Near Normoglycemia|Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).|8 hours|||percentage time near normoglycemia||Standard Error|Mean
15347|NCT01890915|Other Pre-specified|Sweat Rate|To determine the change in sweat rate using QSweat methodology (WR TestWorks) from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Sweat collection capsules will be placed on the left lateral anterior shoulder, volar aspect of the distal forearm, proximal anterior thigh, and mid-lateral calf (dermatomes C5, T1, L3, L5) for measurement of sweat rate. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate after heat exposure.|2 hours|||Percent change||Standard Deviation|Mean
15348|NCT01890915|Secondary|Cognitive Performance - Stroop Interference T-Scores|To determine the change in cognitive performance as measured by the Stroop Color and Word Interference T-Scores, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance from baseline (79 degrees) to warm exposure (95 degrees).|2 hours|||Percent change||Standard Deviation|Mean
15349|NCT01890915|Primary|Core Body Temperature|To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained.|2 hours|||Percent Change||Standard Deviation|Mean
15350|NCT01890785|Primary|Cmax for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours-post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
15351|NCT01890785|Primary|AUC for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*h/ml||Standard Deviation|Mean
15352|NCT01890785|Primary|Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
15353|NCT01890785|Primary|Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*hr/ml||Standard Deviation|Mean
15354|NCT01890746|Primary|Worst-case Post Baseline Change in Temperature Values From Baseline|The worst-case post Baseline high and low changes in temperature values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline was defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).||Degrees Celsius||Standard Deviation|Mean
15355|NCT01890746|Primary|Worst-case Post Baseline Change in Blood Pressure Values From Baseline|The worst-case post Baseline high changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the visit value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||millimeter of mercury (mmHg)||Standard Deviation|Mean
15356|NCT01890746|Primary|Worst-case Change From Baseline in Pulse Rate Values|The worst-case post Baseline high and low changes in pulse rate values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline is defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles)||Beats/minute||Standard Deviation|Mean
15357|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status|The number of participants with worst case post-baseline changes (improved, no change, deteriorated) are presented.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and post-Baseline assessments.||Participants|||Number
15358|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values|The number of participants with worst case post-baseline changes (normal, abnormal - not clinically significant [NCS], abnormal - clinically significant [NS]) in ECG QT prolonged values are presented. The protocol does not define the criteria for normal, abnormal-NCS and abnormal CS ECG. The outcome was based solely on the investigator interpretation of ECG tracings.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||Participants|||Number
15359|NCT01890746|Primary|Number of Participants With Liver Events.|The number of participants with liver enzyme (ALT, AST, ALP, Total bilirubin) abnormalities while receiving study treatment in each arm are presented.|8 weeks|Safety population||Participants|||Number
15360|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 or Grade 4 from their baseline grade are presented. Clinical Clinical Chemistry parameters included only lab tests that are gradable by CTCAE v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population||Participants|||Number
15414|NCT01890148|Secondary|Summary for Change From Baseline for MMP-9 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis||ng/ml||Standard Deviation|Mean
15362|NCT01890746|Primary|Change From Baseline in the Left Ventricular Ejection Fraction (LVEF).|LVEF is a measurement of the percentage of blood leaving heart each time it contracts. LVEF was assessed by an echocardiogram (ECHO) or Multiple Gated Acquisition scan (MUGA). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the Day 42 value minus the Baseline value.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and Day 42 LVEF measurements.||LVEF percent||Standard Deviation|Mean
15363|NCT01890746|Primary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) as a Measure of Safety and Tolerability.|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice|Safety population: all subjects who received at least one dose of investigational product.||Participants|||Number
15364|NCT01890694|Secondary|Tolerability of Diuretic Therapy|Improved ability to tolerate diuretic therapy, as evidenced by reduced adverse events to diuretic therapy and reduced risk of re-hospitalization.|Day 1 until Discharge (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)||||||
15365|NCT01890694|Secondary|Neutrophil Function [Results From the Assay of Neutrophils]|Improved neutrophil function from baseline|Day 1 to Post-discharge (6 months)||||||
15366|NCT01890694|Secondary|Survival|Improved chances of survival when receiving Tolvaptan vs. standard of care|Post-discharge (6 months)||||||
15367|NCT01890694|Secondary|Hospital Readmission Rate|Lower readmission rate|Post-Discharge (6 months)||||||
15368|NCT01890694|Secondary|Renal Function [BUN and Creatinine Laboratory Results]|Improved renal function from baseline|Day 1 to Post-discharge (6 months)||||||
15369|NCT01890694|Secondary|Ascites|Improved control of ascites|Day 1 to Post-discharge (6 months)||||||
15370|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Months 2-6 post-discharge||||||
15371|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Week 1-4 Post-discharge||||||
15372|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|participants will be followed for the duration of hospital stay, an expected average of 2 weeks||||||
15373|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 8||||||
15374|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 6||||||
15375|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 4||||||
15376|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 2|Data not analyzed. Study terminated|||||
15377|NCT01890694|Primary|Length of Hospital Stay||participants will be followed for the duration of hospital stay, an expected average of 2 weeks|Data were not collected due to premature termination of the trial|||||
15378|NCT01890642|Secondary|Pain at J-tip Deployment|Pain when J-tip deployed assessed by video reviewers using pain scale. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|1 minute|||units on a scale||Inter-Quartile Range|Median
15379|NCT01890642|Primary|Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture|"Pain score assessed by video reviewer at J-tip, J-tip noise or researcher approach (1 minute) and at venipuncture (3 minutes). The score at J-tip noise/researcher approach was subtracted from the score at venipuncture to give a number indicating the change in pain scores.~The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min|||units on a scale||Standard Error|Mean
15380|NCT01890642|Secondary|Change in Pain Score From Baseline|"Pain score assessed by video reviewer before intervention (0 minute) and at venipuncture (3 minutes). The score at baseline was subtracted from the score at venipuncture to give a number indicating the change in pain scores.~The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min|||units on a scale||Standard Error|Mean
15381|NCT01890642|Secondary|Fist Attempt Success|Proportion of patients where blood draw was successful on first attempt|up to 3 minutes|||participants|||Number
15382|NCT01890642|Secondary|Pain Score|Pain score as assessed by video reviewers. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|At venipuncture (3 minutes)|||units on a scale||Inter-Quartile Range|Median
15383|NCT01890577|Secondary|Number of Hospitalisations|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
15384|NCT01890577|Secondary|Number of Red Blood Cell Transfusions|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
15385|NCT01890577|Secondary|C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
15386|NCT01890577|Secondary|Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy|Due to the premature termination of the study no outcome measure data were analyzed.|At each 12-week interval over the observation period||||||
15387|NCT01890577|Secondary|Iron Therapy Use|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
15388|NCT01890577|Secondary|ESA/Aranesp Dose Ratio|"Ratio of the calculated mean weekly dose equivalent of an ESA administered immediately prior to conversion to treatment with Aranesp, to the calculated mean weekly dose equivalent of the first dose of Aranesp administered at commencement. Not applicable to participants who were ESA-naive at time of Aranesp commencement.~Due to the premature termination of the study no outcome measure data were analyzed."|Day of commencement of Aranesp||||||
15389|NCT01890577|Secondary|Erythropoiesis Stimulating Agent (ESA) Usage|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
15390|NCT01890577|Secondary|Hemoglobin Within the Range 10-12 g/dL Over Time|Due to the premature termination of the study no outcome measure data were analyzed.|On a continuous basis over the 15-month observation period||||||
15391|NCT01890577|Secondary|Hemoglobin Excursions|Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period||||||
15392|NCT01890577|Primary|Haemoglobin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Each 4-week period for the duration of the study period (15 months)||||||
15393|NCT01890512|Primary|Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit|"The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions.~Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:~no episodes of asystole,~no occurrence of sustained ventricular arrhythmias in the bore,~no loss of capture due to rise in pacing threshold."|one month|||number of MRI related patient adverse ev|||Number
15394|NCT01890473|Secondary|Number of Participants With Blood Hematology, Chemistry Laboratory Values and Urinalysis Laboratory Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: lower limit of normal (LLN); upper limit of normal (ULN); pretreatment (preRX); cells per microliter (cµ/L); milligram per deciliter (mg/dL); milliequivalent (mEq): Hematology: leukocytes (*10^3 c/µL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; eosinophils (*10^3 cµ/L): if value >0.750*10^3 c/µL; lymphocytes (*10^3 cµ/L): if value <0.750*10^3 c/µL or if value >7.50*10^3 c/µL. Chemistry: blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; glucose (mg/dL): <65 mg/dL (low) or >220 mg/dL (high). Urine Blood, urine red blood cell (RBC), urine white blood cell (WBC): if missing PreRX use >= 2, or if Value >= 4, or if preRX = 0 or 0.5 then use >= 2, or if preRX = 1 then use >= 3, or if preRX = 2 or 3 then use >= 4.|Day 1 to 76 days post last dose|All treated participants with laboratory values were included in the safety analysis. n=number of participants evaluated.||participants|||Number
15395|NCT01890473|Secondary|Number of Participants With a Positive Immunogenicity Response Relative to Baseline|Blood samples were screened at baseline, Day 57 and Day 71 for the presence of drug-specific antibodies using Electrochemiluminescence (ECL). A positive immunogenicity response relative to baseline for Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4) and 'possibly immunoglobulin (Ig)’, and ‘Ig and/or Junction Region’, respectively, was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value. Baseline=Pre-dose value.|Day 57, Day 71|All treated participants with at least one post baseline immunogenicity result reported were included in the immunogenicity analysis. n=number of participants evaluated at the specific time point.||participants|||Number
15396|NCT01890473|Secondary|Number of Participants With Adverse Events of Special Interest|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Infections, Autoimmune Disorders, Malignancy, local site reactions, any AE occurring within 24 hours of SC injection. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.||participants|||Number
15397|NCT01890473|Secondary|Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Includes data Day 1 up to 76 days (71 days + 5 day window) post the single dose of study drug.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.||participants|||Number
15398|NCT01890473|Secondary|Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. V/F was measured in liters per kilogram body weight (L/kg)|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||L/kg||Geometric Coefficient of Variation|Geometric Mean
15399|NCT01890473|Secondary|Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. CL/F was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
15400|NCT01890473|Secondary|Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. T-HALF was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||h||Standard Deviation|Mean
15401|NCT01890473|Secondary|Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. Tmax was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||h||Full Range|Median
15402|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve From Time Zero to Extrapolated to Infinity, AUC (INF), of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. AUC (INF) was measured in μg*h/mL|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||μg*h/mL||90% Confidence Interval|Geometric Mean
15403|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve (AUC) From Zero to the Last Time of the Last Quantifiable Concentration (0-T) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. AUC (0-T) was measured in μg*h/mL. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||μg*h/mL||90% Confidence Interval|Geometric Mean
15404|NCT01890473|Primary|Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (μg/mL). Blood samples for pharmacokinetic (PK) parameters were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.||μg/mL||90% Confidence Interval|Geometric Mean
15405|NCT01890343|Primary|Quantitative Amyloid Image Assessment|The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).|50-60 minutes after injection|||SUVr||Standard Deviation|Mean
15406|NCT01890343|Primary|Qualitative Amyloid Image Assessment|Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.|50-60 min after injection|||participants|||Number
15407|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Night Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (night time), by period (safety set).~The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.~One participant left the study on day 2, due to adverse event."|Up to 44 days|||Observations|Participants||Number
15408|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Day Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (day time), by period (safety set).~The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.~One participant left the study on day 2, due to adverse event."|Up to 44 days|||Observations|Participants||Number
15409|NCT01890148|Secondary|Number of Participants With Adverse Events|Summary of number of participants with adverse events (safety set)|Up to 40 days|||Participants|||Number
15410|NCT01890148|Secondary|Number of Adverse Events|Summary of number of adverse events (safety set)|Up to 40 days|||adverse events|||Number
15411|NCT01890148|Secondary|Summary Statistics for Cmax on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmax on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)|||nmol/L||Standard Error|Geometric Mean
15412|NCT01890148|Secondary|Summary Statistics for Cmin on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmin on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)|||nmol/L||Standard Error|Geometric Mean
15413|NCT01890148|Secondary|Summary Statistics for AUC0-4hrs on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for AUC0-4hrs on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)|||h*nmol/L||Standard Error|Geometric Mean
15419|NCT01890148|Primary|Summary for Change From Baseline of Mean Global Semi-quantitative Score Values for Neutrophils in Bronchial Biopsies|"Change from baseline reflects the Week 4 value minus the baseline value. Baseline value is Day-14 measurement.~For semi-quantitative scores, 1= few number of Neutrophils, 2= moderate number of Neutrophils, 3= abundant of Neutrophils. For this end point the reduction in mean of semi-quantitative (arbitrary) scores indicates better result, i.e. lower numbers of Neutrophils.~The scores given for the biopsies taken at screening and end of treatment is the mean global semi-quantitative scores for the three compartments intraepithelial, subepithelial and submucosal."|Baseline and Week 4|PD analysis set||Units on a scale||Standard Deviation|Mean
15420|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥2.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15421|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15422|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15423|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥0.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15424|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15425|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.0%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15426|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤6.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤6.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15427|NCT01890122|Secondary|Change From Baseline in Body Weight at Weeks 12 and 26|Change in participant's body weight at Weeks 12 and 26 relative to baseline.|Baseline and Weeks 12 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."||kg||Standard Deviation|Median
15428|NCT01890122|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L).|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15429|NCT01890122|Secondary|Percentage of Participants Requiring Hyperglycemic Rescue|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline.|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.||percentage of participants|||Number
15458|NCT01888900|Primary|Changes in Interferon Stimulated Genes in the Liver|"Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression.~The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray."|baseline and either 2 or 4 weeks|one patient in genotype 1A arm was not included in primary outcome data collection due to late enrollment.||relative expression||Inter-Quartile Range|Median
15430|NCT01890122|Secondary|Time to Hyperglycemic Rescue Event|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline. Time to hyperglycemic rescue was censored if the participant did not experience a hyperglycemic rescue event.|From the date of randomization through Week 26|Randomized set consisted of all enrolled participants who were randomized.||days||Inter-Quartile Range|Median
15431|NCT01890122|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26|The change between the FPG value collected at Weeks 4, 8, 12, 16, 20 and 26 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16, 20 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."||mg/dL||Standard Deviation|Mean
15432|NCT01890122|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16 and 20|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."||percentage of glycosylated hemoglobin||Standard Deviation|Mean
15433|NCT01890122|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.|Baseline and Week 26 (or Early termination)|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
15434|NCT01890031|Secondary|Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months|We will assess adherence (for those who are prescribed a statin in the moderate CVD risk group) by both indirect objective measures and subjective reports. The study design did not include prescription of a cholesterol-lowering medication as per randomization. Participants were prescribed a statin as standard of care based on the participants and physicians agreement. Low risk individuals have less need for medication compared to moderate risk based on the current science.|9 months|||participants|||Number
15435|NCT01890031|Primary|LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants||9 months|||mg/dL||Standard Deviation|Mean
15436|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo|Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2, Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring||mg/dL||Standard Deviation|Mean
15437|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting Serum Insulin|Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2. Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring||mg/dL||Standard Deviation|Mean
15438|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations||mg/dL||Standard Deviation|Mean
15439|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations||mg/DL||Standard Deviation|Mean
15440|NCT01889667|Primary|Evaluate the Safety and Tolerability of ORMD-0801.|Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug|Eight (8) days|||Number of Events|||Number
15441|NCT01889563|Secondary|Walking Distance on Six Minute Walking Test|Patients underwent the assessments proposed in the study on an outpatient basis before physical exercise training program and after 6 and 12 weeks of physical exercise training program. The second end-point was walking distance on six minute walking test.|Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program|||meters||Standard Deviation|Mean
15442|NCT01889563|Primary|The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.|Patients underwent the assessments proposed in the study on an outpatient basis before and after 6 and 12 weeks of physical exercise training program. The primary end-point measure was the SD1, a nonlinear index of HRV that represent the parasympathetic modulation|baseline (before physical exercise training program), 6 and 12 weeks after intervention|||miliseconds||Standard Deviation|Mean
15509|NCT01886807|Primary|Oxygen Saturation|In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome.|From start of intubation attempt to completion of intubation||||||
15443|NCT01889420|Secondary|Overall Response Rate (RR)|"ORR is the percentage of patients with a > Partial Response (PR). Response is assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle.~Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.~PR: >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.~Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3 years|There was only one patient enrolled. Response rates cannot be accurately reported based on one patient.|||||
15444|NCT01889420|Secondary|Anti-tumor Effect|"Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement.~Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.~Partial response (PR): >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.~Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3.5 years|There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.|||||
15445|NCT01889420|Secondary|Toxicity Profile|The toxicity profile will be described by specific adverse event rates among patients experiencing > grade 3 hematologic events (lasting >7 days) or grades 3-5 non-hematologic adverse events, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. Specific events will be described as the numbers of patients experiencing them within each treatment cohort.|2 years||||||
15446|NCT01889420|Primary|Maximum Tolerated Dosage (MTD)(Phase I)|The Maximum Tolerated Dose (MTD) will be determined by first identifying the dose level at which >= 30% of patients experience a Dose Limiting Toxicity (DLT) according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. DLT will be defined based on the rate of drug-related grade 3-5, non-hematological adverse events experienced within the first 4 weeks (1 cycle) for each combined dosage scheme. The MTD will be defined as one dosage level below which DLT was observed in >= 30% of patients.|2 years|There was only one patient enrolled. The MTD could not be calculated based on one patient.|||||
15447|NCT01889251|Primary|Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)|VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.|Day 28|This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.||percentage of subjects|||Number
15448|NCT01888965|Secondary|Safety|Percent of subjects who experience grade 3/ 4 adverse events|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.||percentage of participants|||Number
15449|NCT01888965|Secondary|Progression-free Survival|"Time in days from study entry until disease progression or death~Disease progression was defined according to RECIST as at least a 20% increase in the sum of the longest diameter of the target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions"|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.||days||Full Range|Median
15450|NCT01888965|Primary|Biomarker Discovery|Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum|2 years|Data cannot be summarized in the data table because biomarker analysis did not take place after study closure due to insufficient number of samples to yield significant results related to dovitinib administration. Instead, collected samples are stored in our biobank, as consented by all patients, for future Oncological analyses of importance.|||||
15451|NCT01888900|Secondary|Rates of Asunaprevir and Daclatasvir Resistance||post treatment|||Participants|||Count of Participants
15452|NCT01888900|Secondary|Virological Relapse|HCV RNA >= LLOQ level after therapy is stopped in a patient who previously achieved an end-of-treatment virological response|beyond Week 24 post treatment|||Participants|||Count of Participants
15453|NCT01888900|Secondary|Serum Aminotransferase Levels|whether raw ALT value is in normal range which is less than 41 U/L.|Week 12 post treatment|||Participants|||Count of Participants
15454|NCT01888900|Secondary|Sustained Virological Responder|sustained virological response at follow-up week 12|Week 12 post treatment|||Participants|||Count of Participants
15455|NCT01888900|Secondary|End of Treatment Responder|end of treatment response (HCV RNA <LLOQ Target not Detected at week24)|Week 24 post treatment|||Participants|||Count of Participants
15456|NCT01888900|Secondary|Extended Rapid Virological Responder|extended rapid virological response (HCV RNA <LLOQ Target not Detected at both weeks 4 and 12)|Both weeks 4 and 12 post treatment|||Participants|||Count of Participants
15457|NCT01888900|Secondary|Rates of Rapid Virological Responder|rapid virological response (HCV RNA <LLOQ Target not Detected) at week 4|Week 4 post treatment|||Participants|||Count of Participants
15831|NCT01877720|Secondary|Ti_excess (Inspiratory Time in Excess)|"Ti_excess = (VPT-NIT)/NIT~VPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value"|last 5-min of each 15-min trial|||percentage of neural inspiratory time||Standard Deviation|Mean
15459|NCT01888367|Secondary|Cumulative ASEPSIS Score for Each Patient|Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.|Through post-operative Day 4|"Safety analyses were as treated so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized."||units on a scale||Standard Deviation|Mean
15460|NCT01888367|Secondary|Change in Serum Creatinine Measurements From Baseline|Change from baseline in micromoles/liter|Within 4 days of surgery|"402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were as treated so patients randomized to gel but did not receive it in surgery were counted in the SOC group."||micromoles/liter||Standard Deviation|Mean
15461|NCT01888367|Secondary|Number of Patients With Adverse Events||Within 30 days of surgery|"The safety analysis was as treated. For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group."||participants|||Number
15462|NCT01888367|Primary|Number of Patients With Surgical Site Infections||Within 30 days of surgery|The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.||participants|||Number
15463|NCT01888003|Primary|Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery|number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery|post hospital discharge through 90 days after surgery|Subjects dropped out of study prior to day 90|||||
15464|NCT01888003|Primary|Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital|Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital|post surgery through discharge, an average of 2 days|||participants|||Number
15465|NCT01888003|Secondary|Health-related Quality of Life|Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale|Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery|No subject data was analyzed.|||||
15466|NCT01888003|Primary|Number of Subjects Requiring at Least One Blood Transfusion During Surgery.|The number of subjects who had blood transfusions (at least 1) during surgery|During surgery (less than 1 day)|||Participants|||Number
15467|NCT01887990|Secondary|Depression|Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60|2 hours|||units on a scale||Standard Deviation|Mean
15468|NCT01887990|Primary|Suicidality|"Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation.~Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide."|2 hours|||units on a scale||Standard Deviation|Mean
15469|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived). Tablets Taken.|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) (study population measure statistically derived). Total number of tablets taken as reported by patient.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||Tablets||Standard Deviation|Mean
15470|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived) - Patients Use|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) as reported by the patients. Patients who used any rescue medication during the study.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
15471|NCT01887678|Secondary|Patients Achieving 100% Pain Relief|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 100% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment, however, the prevalence of 100% pain relief did not support an estimate for the median time. The number of patients who reached 100% pain relief is reported and the log rank test for difference in time to 100% pain relief was calculated for each injection.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
15523|NCT01886300|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period|A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
15472|NCT01887678|Secondary|Time to 50% Pain Relief (Study Population Measure Statistically Derived)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 50% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||days||95% Confidence Interval|Median
15473|NCT01887678|Other Pre-specified|Proportion of Patients Who Discontinued Due to an AE|Total number of patients affected.|All visits (Days 1 up to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. Medical Dictionary for Regulatory Activities (MedDRA) Version 16.0 terminology.||participants|||Number
15474|NCT01887678|Other Pre-specified|Incidence of Treatment Emergent Adverse Events (TEAEs)|Total number of patients affected.|during the treatment period and follow up period (Days 11 to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology. Adverse events during treatment (treatment-emergent) in 5% or more of total study patients||participants|||Number
15475|NCT01887678|Other Pre-specified|Each Adverse Event (AE)|Total number of patients affected.|Starting at Visit 2/ Start of Lead-In period (Day 7 up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. 8 patients without any injection (not randomized) reported 12 adverse events||participants|||Number
15476|NCT01887678|Other Pre-specified|Serious Adverse Events|Total number of patients affected.|Start of Lead-In period until individual study end, up to 16 weeks.|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology||participants|||Number
15477|NCT01887678|Secondary|Time to Walking (50-foot Walk Test)|Changes in time to walk 50 feet (seconds)|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||seconds||Standard Deviation|Mean
15478|NCT01887678|Secondary|Pain Immediately Following the 50-foot Walk (100 mm VAS)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’.|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
15479|NCT01887678|Secondary|Physician Global Assessment (PhGA)|Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
15480|NCT01887678|Secondary|Physician Global Assessment (PhGA)|Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
15481|NCT01887678|Secondary|Patient Global Assessment (PGA)|Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
15482|NCT01887678|Secondary|Patient Global Assessment (PGA)|Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|from Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||participants|||Number
15483|NCT01887678|Secondary|Total WOMAC Score (All Subscales) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. A total WOMAC score was computed by averaging all 24 possible responses. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in total WOMAC score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
15484|NCT01887678|Secondary|Physical Function Bubscore (WOMAC Section C, Items #8-24) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess physical function, scores from WOMAC Section C, items 8 to 24 are averaged to yield the Physical Function Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in Physical Function subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
15485|NCT01887678|Secondary|Stiffness Subscore (WOMAC Section B, Items #6-7) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess stiffness, scores from WOMAC Section B, items 6 to 7 are averaged to yield the Stiffness Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in stiffness score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
15486|NCT01887678|Secondary|Pain Subscore (WOMAC Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in pain subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline to post-Baseline visits except End of Study Visit (up to day 105)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
15487|NCT01887678|Primary|Change in Knee Pain as Measured by the WOMAC Osteoarthritis (OA) Index Pain Subscale (Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. A two-sided test of equality of the study drug (Traumeel®-Zeel®) and Placebo at level 0.05 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the corresponding Baseline value of the primary efficacy variable as a covariate. The test decision was based on the (two-sided) p-value for the corresponding test of no treatment difference.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
15488|NCT01887470|Secondary|Colonic Methane Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||parts per million by volume||Full Range|Mean
15489|NCT01887470|Secondary|Colonic Hydrogen Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||parts per million by volume||Standard Deviation|Mean
15490|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications."|3 to 15 hours post last consumption|Of the 40 participants responding to the patient questionnaire, only 21 reported that they had had a previous colonoscopy; therefore, the other 19 are not included in this outcome measure.||percentage of participants|||Number
15491|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied Yes to this survey question."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||Percentage of Participants|||Number
15510|NCT01886781|Primary|A Change in Abdominal Pain Severity|The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500|Total trial period 12 weeks|||units on a scale||Standard Deviation|Mean
15492|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3|"Tolerability assessed by a patient questionnaire - Likert response to The dosing instructions were easy to understand and follow Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on Likert Scale||Standard Deviation|Mean
15493|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2|"Tolerability assessed by a patient questionnaire - Likert response to I did not experience too much discomfort during the bowel prep Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on Likert Scale||Standard Deviation|Mean
15494|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1|"Tolerability assessed by a patient questionnaire - Likert response to was regimen a tolerable bowel prep? Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on Likert Scale||Standard Deviation|Mean
15495|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)|"A paper questionnaire contained a horizontal line 100 mm long with the right end labeled Best Possible Experience and the left end labeled Worst Possible Experience. The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation.~Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.||units on VAS scale||Standard Deviation|Mean
15496|NCT01887470|Secondary|Incidence of Treatment Failure|A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0.|at least 3 hours post last consumption|The study objectives in the protocol called for the incidence of treatment failures to be calculated from the pooled data of all treatment participants. Therefore, outcome measures are not displayed with respect to individual treatment groups.||participants|||Number
15497|NCT01887470|Primary|Efficacy of Lactulose as a Preparation for Colonoscopy.|"Efficacy assessed by the physician’s determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue.~The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility."|at least 3 hours post last consumption|||units on a scale||Standard Deviation|Mean
15498|NCT01887418|Primary|The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks|The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST||ng/dL||Standard Deviation|Mean
15499|NCT01887418|Primary|The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks|The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST||ng/dL||Standard Deviation|Mean
15500|NCT01887418|Primary|The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks|The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST||ng*hr/dL||Standard Deviation|Mean
15501|NCT01887418|Secondary|Number of Patients in the PK Parameter Category|The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE|6 weeks|||participants|||Number
15502|NCT01887353|Primary|Time to First Atrial Fibrillation (AF) Recurrence|There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead|up to 6 months|||participants|||Number
15503|NCT01886963|Primary|Wound Complication|breakdown, necrosis, erythema, infection, or dehiscence with location specified|12 Weeks|||participants|||Number
15504|NCT01886807|Secondary|Blood Loss||At the completion of intubation||||||
15505|NCT01886807|Secondary|Intubation Duration||From start of intubation attempt to completion of intubation||||||
15506|NCT01886807|Secondary|Blood Pressure||From start of intubation attempt to completion of intubation||||||
15507|NCT01886807|Secondary|Heart Rate||From start of intubation attempt to completion of intubation||||||
15508|NCT01886807|Primary|Time to 1% Saturation Drop|Kaplan-Meyer estimate 25th percentile along with adjusted 95% confidence limits were reported instead of usual 50th percentile (median) since there was not enough non-censored data for the DLO2 group (not many patients dropped 1% in SO2 from their baseline )|From beginning to end of laryngoscopy|||seconds||95% Confidence Interval|Median
15511|NCT01886716|Primary|The Daily Drinking Questionnaire|The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)|||number of drinks||Standard Deviation|Mean
15512|NCT01886716|Primary|Liebowitz Social Anxiety Scale|The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)|||units on a scale||Standard Deviation|Mean
15513|NCT01886690|Secondary|Change From Baseline in Uncorrected Visual Acuity in the Worse Eye|Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point||Letters Read Correctly||Standard Deviation|Mean
15514|NCT01886690|Secondary|Change From Baseline in the Schirmer Test in the Worse Eye|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point||Millimeters in 5 minutes (mm/5 min)||Standard Deviation|Mean
15515|NCT01886690|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point||Seconds||Standard Deviation|Mean
15516|NCT01886690|Secondary|Change From Baseline in Corneal Staining in the Worse Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point||Scores on a Scale||Standard Deviation|Mean
15517|NCT01886690|Primary|Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale|The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 90|Per Protocol: all randomized patients who had no significant protocol violations||Scores on a Scale||Standard Deviation|Mean
15518|NCT01886300|Secondary|Number of Participants With Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product|Up to 24 months|Participants present at the time of assessment were used for analysis.||Number of participants|||Number
15519|NCT01886300|Secondary|Incidence of Normalization of Serum Alanine Transaminase|Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
15520|NCT01886300|Secondary|Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period|HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
15521|NCT01886300|Secondary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period|HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
15522|NCT01886300|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period|Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) ‘NEGATIVE’ or (b) a quantitative result was lower than the reported lower detection limit.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
15524|NCT01886300|Primary|Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment|HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|12 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
15525|NCT01886300|Primary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|6 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.|||||
15526|NCT01886287|Secondary|Rate of Progression Free Survival (PFS) at 6 Months|Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months. Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|At 6 months|Evaluable participants on study at 6 months|||||
15527|NCT01886287|Primary|Number of Participants With Improved Frequency of Diarrhea|The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.|At 12 weeks|Participants on study at 12 weeks||participants|||Number
15528|NCT01885910|Secondary|Burning|the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
15529|NCT01885910|Secondary|Pruritis|the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
15530|NCT01885910|Secondary|Oiliness|the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
15531|NCT01885910|Secondary|Peeling|the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling|every four weeks|participants with data||units on a scale||Standard Deviation|Mean
15532|NCT01885910|Secondary|Dryness|the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
15533|NCT01885910|Secondary|Erythema|the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema|every 4 weeks|participants with data||units on a scale||Standard Deviation|Mean
15534|NCT01885910|Secondary|Nodule Counts|number of nodules counted|every four weeks|participants with data||nodules||Standard Deviation|Mean
15535|NCT01885910|Secondary|Percentage of Participants Who Are Responders at Week 16 and 20|Responders is the percentage of participants who have an IGA <3 at Week 16 and 20|Assessed every 4 weeks, reported at weeks 16 and 20|||percentage of participants|||Number
15536|NCT01885910|Secondary|Inflammatory and Non-inflammatory Lesion Counts||Every 4 weeks|participants with data||lesions||Standard Deviation|Mean
15537|NCT01885910|Primary|Percentage of Participants Who Remained Responders at Week 24|At week 12 responder had an IGA <3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained|Assessed every 4 weeks, reported at Week 24|only participants who were not lost to follow-up or did not withdraw consent were included in the final analysis||percentage of particpants|||Number
15538|NCT01885871|Secondary|Percent of Subjects With Post-treatment Adverse Event||During study duration 0-6 months.|||percent of participants|||Number
15539|NCT01885871|Secondary|Mean Pain Score Associated With Laser Treatment|Subjects graded the level of pain associated with laser treatment using a 0-10 scale where 0=no pain and 10=worse possible pain.|During treatment|||units on a scale||Full Range|Mean
15540|NCT01885871|Secondary|Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines|Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants.|12 weeks post- final treatment|Based on subject questionnaires, 90% of subjects reported improvement (clearing) in benign pigmented lesions at 12 weeks post- final treatment. Scores >/=1 indicate improvement.||percent of participants|||Number
15541|NCT01885871|Secondary|Percent of Participants With Improvement Score >/=1|Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores >/=1 indicate improvement.|12 weeks post- final treatment|||percent of participants|||Number
15542|NCT01885871|Primary|Median VAS Improvement Score as Assessed by Blinded Physician Reviewers|Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.|12 weeks post- final treatment|Based on blinded photographic assessments of 20 subjects. Scores >/=1 indicate clearing.||units on a scale||95% Confidence Interval|Median
15543|NCT01885559|Secondary|Pain|Kidney pain (back or flank pain) experienced in since last visit|48 months|Cross sectional analysis at 48 months is reported only for those participants responding at that time point. Intention to treat analysis was used for in the modeling over time to incorporate all repeated measures.||percentage of participants at 48 months||95% Confidence Interval|Number
15544|NCT01885559|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis||units on a scale per year||95% Confidence Interval|Mean
20563|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
15545|NCT01885559|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to Treat analysis||units on a scale per year||95% Confidence Interval|Mean
15546|NCT01885559|Secondary|Cardiovascular Hospitalizations|Cause-specific hospitalizations (cardiovascular)|up to 8 years|Intention to Treat analysis||events|||Number
15547|NCT01885559|Secondary|Hospitalizations|Hospitalization for any cause|up to 8 years|Intention to treat analysis||events|||Number
15548|NCT01885559|Secondary|Aldosterone|Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.|up at 8 years (annually assessed)|Intention to treat analyses||annual percent change||95% Confidence Interval|Mean
15549|NCT01885559|Secondary|Albuminuria|Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis||annual percent change||95% Confidence Interval|Mean
15550|NCT01885559|Primary|Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.||Patients followed for 5-8 years with average of 6.5 years follow up|Intention to Treat analysis was used for the primary outcome||participants|||Number
15551|NCT01885117|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.|Day 1(baseline) through Day 22 postvaccination|Analysis was done on the safety set population||Subjects|||Number
15552|NCT01885117|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.|Day 1 through Day 4 postvaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records||Subjects|||Number
15553|NCT01885117|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/ Day 1|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
15554|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if>40 % for adults aged 18 to ≤60 years and>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population||percentages of subjects||95% Confidence Interval|Number
15555|NCT01885117|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
15556|NCT01885117|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
15557|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (Baseline)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
15618|NCT01882907|Secondary|To Compare Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups|"Safety assessments~- hypoglycemia, other side effects, Laboratory data, Physical examination, Vital sign with blood pressure and pulse rate, Electrocardiography"|16 weeks, visit 3,4,5||||||
15558|NCT01885117|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.||Percentages of subjects||95% Confidence Interval|Number
15559|NCT01885104|Primary|Number of Participants With Inflammation of the Esophageal Mucosa|Participants underwent endoscopic examination of the esophageal mucosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.||Participants|||Number
15560|NCT01885104|Primary|Number of Participants With Inflammation of the Oral Mucosa|Participants underwent visual examination of the oral muscosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.||Particpants|||Number
15561|NCT01885000|Secondary|Percentage of Subject Reporting a Treatment-related Adverse Event||Throughout the study|APT (All Patient Treated) population||percentage of participants|||Number
15562|NCT01885000|Secondary|Percentage of Participants With at Least One Grade Improvement in the Clinician's Erythema Assessment (CEA)|Percentage of participants with at least one grade improvement in the CEA|Day 1, 3 hour after drug application|Participantes with a CEA score at this timepoint||percentage of participants|||Number
15563|NCT01885000|Secondary|Facial Appearance Since Starting the Treatment|"Percentage of subjects who answered A lot better/A little better to the question what do you think about your facial appearance since starting the treatment?"|Day 8|Subjects who answered the questionnaire at Day 8||percentage of participants|||Number
15564|NCT01885000|Primary|Satisfaction With the Overall Study Treatment|Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment|Day 8|Subject who have answered the questionnaire at Day 8||percentage of participants|||Number
15565|NCT01884675|Secondary|Number of Participants With Testicular Function (Males Only) of Potential Clinical Concern Any Time Post Baseline|For male participants testicular function (total testosterone, sex hormone binding globulin [SHBG-calculated free testosterone), follicle stimulating hormone (FSH), luteinizing hormone (LH), and inhibin B were assessed at Weeks 4 and 16/early withdrawal. Due to the small participant numbers in this study, testicular function data were not analysed.|Baseline, Weeks 4 and 16/early withdrawal|ITT Population|||||
15566|NCT01884675|Secondary|Number of Participants With Hematology Parameters of Potential Clinical Concern Any Time Post Baseline|Hematology parameters including hemoglobin, international normalized ratio (INR), and platelet count assessed any time post Baseline. Baseline is the last value recorded on or prior to start of study treatment. For hemoglobin: lower concern value and high concern value was considered as <100 gram per liter (G/L) and none respectively. For INR: lower concern value and high concern value was considered as none or >5 prothrombin time respectively. For platelet count: lower concern value and high concern value was considered as <50 giga cells per liter (GI/L) and >500 GI/L respectively. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Participants|||Number
15567|NCT01884675|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern Any Time Post Baseline|Clinical chemistry parameters including alanine amino transferase (ALT), aspartate amino transferase (AST), creatinine, gamma glutamyl transferase (GGT) and total bilirubin (TB) assessed any time post Baseline. ALT: lower concern value and high concern value was considered as none and >=3xupper limit of normal (ULN) respectively. AST: lower concern value and high concern value was considered as none or >=3xULN respectively. creatinine: lower concern value and high concern value was considered as none and >=176.8 micromoles per liter (umol/L) respectively. GGT: lower concern value and high concern value was considered as none and >=3xULN respectively. For TB: lower concern value was none and high concern value was >=2xULN. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal,|ITT Population||Participants|||Number
15568|NCT01884675|Secondary|Change From Baseline in Heart Rate Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including heart rate at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||beats per minute||Inter-Quartile Range|Median
15619|NCT01882907|Secondary|To Compare Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
15569|NCT01884675|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including supine systolic and diastolic blood pressure at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Supine blood pressure measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||millimeter of mercury (mmHg)||Inter-Quartile Range|Median
15570|NCT01884675|Secondary|Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal|A significant liver chemistry result is defined as any result which met the stopping criteria defined in the study protocol. Liver events were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Number of participants who reported a significant liver chemistry result are presented.|Weeks 4, 8, 12, and 16/Early Withdrawal|ITT Population||Participants|||Number
15571|NCT01884675|Secondary|Change From Baseline in Haematocrit Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haematocrit levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Proportion of 1||Inter-Quartile Range|Median
15572|NCT01884675|Secondary|Change From Baseline in Haemoglobin Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haemoglobin levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Grams per liter||Inter-Quartile Range|Median
15573|NCT01884675|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment and until follow up (Week 16/Follow up)|ITT Population||Participants|||Number
15574|NCT01884675|Secondary|Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Due to the small participant numbers in this study, the SF-36 data were not analysed.|Baseline and up to Week 16/Early Withdrawal|ITT Population|||||
15575|NCT01884675|Secondary|Percent Change From Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The ratio to baseline [BL] in NT-proBNP was calculated as the ratio of the value at the specified time-point to the BL value and was expressed as a percent change from BL. For each treatment group, the mean change from BL at the specified time-point was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the value at the specified time-point to BL on the original scale. The GM was expressed as a percentage (100*[GM – 1]). Standard Deviation(SD) is the SD of the mean change from baseline values on the log scale.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Percent change||95% Confidence Interval|Geometric Mean
15576|NCT01884675|Secondary|Change From Baseline in Cardiac Index at Week 16|Cardiac index is measure of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint were summarized.||Litre per minute per meter per square||Inter-Quartile Range|Median
15577|NCT01884675|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) and Mean Pulmonary Artery Pressure (mPAP) at Week 16|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Millimeter of mercury (mmHg)||Inter-Quartile Range|Median
15620|NCT01882907|Secondary|To Compare Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
15621|NCT01882907|Secondary|To Compare Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks , visit 5||||||
15578|NCT01884675|Secondary|Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Clinical worsening of CTEPH is defined by the time from randomization to the first occurrence of death, lung transplantation, hospitalization for CTEPH, atrial septostomy, addition of parenteral prostanoids, or study withdrawal due to two or more early escape criteria included: a decrease from Baseline of at least 20 percent in the distance walked during the six-minute walk test; an increase of one or more WHO functional class; worsening right ventricular failure (e.g., as indicated by increased jugular venous pressure; new/worsening hepatomegaly, ascites, or peripheral edema; worsening echocardiographic parameters such as tricuspid annulus plane systolic excursion (TAPSE) and Tissue Doppler Imaging of the tricuspid annulus); rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (systolic blood pressure less than 85 millimeter of mercury [mmHg]).|From randomization to Week 16/Follow up visit (21 weeks)|ITT Population||Participants|||Number
15579|NCT01884675|Secondary|Change From Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at Weeks 4, 8, 12 and 16/Early Withdrawal|The BCR10S score was collected immediately following completion of the 6-minute walk test. Baseline data was calculated as the average of the two BCR10S values obtained following the two 6MWD tests used in determining the Baseline 6MWD. If only one measurement was available, that measurement has been used. BCR10S scores ranges from 0 to 10 (0=nothing at all, 10=extremely strong). If participant's perception or feeling was stronger than ”10”, i.e “extremely strong”, “Maximal” – a larger number could be used, e.g. 12 or still higher i.e “Absolute maximum”). Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Scores on a scale||Inter-Quartile Range|Median
15580|NCT01884675|Secondary|Change From Baseline in WHO Functional Class (FC) at Weeks 4, 8, 12 and 16/Early Withdrawal|The WHO FC indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. For analyse purposes, the WHO FC Class categories of I-IV were mapped to a numeric scale of 1-4.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Scores on a scale||Inter-Quartile Range|Median
15581|NCT01884675|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16|PVR is a measure of cardiopulmonary haemodynamics. Change from Baseline was calculated as value at specified visit minus Baseline value. Baseline is the last value recorded on or prior to start of study treatment.|Baseline (Week 0) and Week 16|ITT Population. Only those participants with available data at Baseline and the specified timepoint were analysed.||Dynes*second/centimeter^5||Inter-Quartile Range|Median
15582|NCT01884675|Primary|Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16|The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Change from baseline was calculated at Weeks 4, 8, 12 and 16. Change from Baseline was calculated as value at the specified visit minus the Baseline value. Data at Baseline is based on average of two consecutive test results during Screening/Baseline period that differ by <10%. If only one measurement was available, that measurement was used. In any cases where the protocol-defined criteria for Baseline 6MWD was not met, the Baseline value was based on the last two consecutive measurements for a participant.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.||Meters||Inter-Quartile Range|Median
15583|NCT01884519|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15584|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15585|NCT01884519|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
15622|NCT01882907|Primary|Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group||16 weeks|||% (change of HbA1c)||Standard Deviation|Mean
41612|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban After Three Days of 15 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
15586|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15587|NCT01884519|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
15588|NCT01884519|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15589|NCT01884519|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
15590|NCT01884519|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15591|NCT01884519|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15592|NCT01884519|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
15593|NCT01884519|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15594|NCT01884519|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
15595|NCT01884519|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15596|NCT01884519|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15597|NCT01884519|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
15598|NCT01884064|Primary|Cortical Silent Period|Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.|Baseline and Day 5|||milliseconds||Standard Deviation|Mean
15599|NCT01883999|Secondary|Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)|Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria||participants|||Number
15600|NCT01883999|Primary|Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC|"Freedom from all of the following:~Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).~Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory~Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC."|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria||participants|||Number
15601|NCT01883999|Primary|Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair|Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.|30 days post-treatment|Subjects initiating IBE procedure and meeting inclusion/exclusion criteria||participants|||Number
15602|NCT01883986|Secondary|Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months|Clinician knowledge of patient preferences for life sustaining treatments will be assessed at baseline and at the study end point by asking 2 validated questions to both the clinician and the patient and determining the level of agreement between the responses.|Baseline and 3 months|No data was collected due to poor provider response to surveys.|||||
15603|NCT01883986|Secondary|Change in Baseline Quality of Clinician Communication at 3 Months|"The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).The QOC consists of 13 items divided into two subscales, six general communication items and seven end-of-life topics. We analyzed the six-item general communication skills scale, which scores range from 0-10. The higher the score the better the provider's communication is. We asked patients to answer the questions in reference to the provider who was primarily responsible for managing their lung cancer."|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
15604|NCT01883986|Secondary|Change From Baseline in Patient Satisfaction of Care at 3 Months|Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total scores are reported (no subscales). The total scores range from 13-65 with scores of 52 > indicating satisfaction with care. The higher the score the better the outcome (better satisfaction with care). In full randomized clinical trials, the estimated minimal important difference is 5 points from baseline to 12 weeks.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
15850|NCT01877148|Primary|Change From Unified Parkinson´s Disease Rating Scale - UPDRS|"Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome), as accurate and appropriate"|At baseline, after 1 month|||units on a scale||Standard Error|Mean
15605|NCT01883986|Primary|Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months|Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
15606|NCT01883908|Primary|Number of Patients Completing Acupuncture Treatment|Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.|16 weeks|Zero participants analyzed due to early termination of study.|||||
15607|NCT01883908|Primary|Side Effects of Acupuncture Treatment|All acupuncture side effects will be recorded|16 weeks|Zero participants analyzed due to early termination of study.|||||
15608|NCT01883635|Other Pre-specified|Provision of Social Support|Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.|Baseline to post-intervention (6 weeks later)|This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).||units on a scale||Standard Deviation|Mean
15609|NCT01883635|Secondary|Immune Biomarkers|We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.|Baseline to post-intervention (6 weeks later)|The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).||ng/mL||Standard Deviation|Mean
15610|NCT01883635|Primary|Psychological Distress|Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.|Baseline to post-intervention (6 weeks later)|The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).||units on a scale||Standard Deviation|Mean
15611|NCT01883453|Primary|Reducing Symptoms of a Common Cold|"Using the Wisconsin Upper Respiratory Symptom Score (WURSS-21)it is possible to assess if a nasal spray containing glucose oxidase and glucose would be able to reduce symptoms of a common Cold.~WURSS 21 is a validated tool of calculating the degree of common Cold symptoms. It consists of 21 questions (20 questions are possible to evaluate) which are graded from 0 to 7 (worst degree of symptoms). These 20 questions (sum of all symptoms) are evaluated every day, Min value is thus 0 and max value/person/day is 140. It is thus possible to calculate the mean value of sum of symptoms for each day in the both groups."|One week|Only the participants that fullfilled the study and who had a positive virus sample (Influensa and adenoviruses excluded) were included in the results. These are the participants that are supposed to benefit from a nasal spray with GO.||units on a scale||Full Range|Mean
15612|NCT01883440|Primary|Sum of All Symptoms of All Persons That Fullfilled the Study|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|7 days|All of the persons that fullfilled the study||units on a scale||Full Range|Mean
15613|NCT01883440|Primary|Sum of All Symptoms in Viruspositive Persons|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|One week|The persons analyzed were those that had a positive viral sampling with Parainfluenza, Corona or Rhinoviruses, that is: the viruses that most often causes common cold and also would be accessible for treatment with a nasal spray.||units on a scale||Full Range|Mean
15614|NCT01883427|Primary|Respiratory Infectious Symptoms|Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.|3 months of recording|Only a total of 40 Children fulfilled the study, which means that the Power are to low.||days||Standard Deviation|Mean
15615|NCT01882907|Other Pre-specified|To Compare Changes of Adipocytokine From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
15616|NCT01882907|Other Pre-specified|To Compare Changes of Homeostasis Model Assessment-insulin Resistance and Beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
15617|NCT01882907|Other Pre-specified|To Compare Changes of Insulin and C-peptide From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5||||||
41613|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban After Three Days of 15 mg IV Daily in HRS Type 2 Patients||3 days|||hr||Standard Deviation|Mean
15623|NCT01882725|Secondary|Change in Skin Surface Temperature on the Hind Foot|"Skin surface temperature on the hind foot was recorded in degrees using an infrared thermometer. Change in skin surface temperature in degrees was calculated as the change in measurements before the first procedure administration (baseline) to after the sixth and final procedure administration. It was pre-determined that a minimum mean increase in skin surface temperature of +2.5 degrees across the procedure administration phase would be considered clinically meaningful.~A positive (+) change indicates that the skin surface temperature increased across the procedure administration phase and is positive for study efficacy.~A negative (-) change indicates that the skin surface temperature decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks|||Degrees Farenheit||Standard Deviation|Mean
15624|NCT01882725|Primary|Change in Skin Perfusion Pressure (SPP)|"Skin Perfusion Pressure (SPP) measured peripheral microcirculation or skin perfusion using a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia, the transient increase in blood flow that occurs following a brief period of ischemia. The SPP value was measured in mmHg.~The per cent (%) change in mean Skin Perfusion Pressure (SPP) in mmHg was calculated as the % change in measurements from before the first procedure administration with the Erchonia® HPS Laser to after the sixth and final procedure administration. It was pre-determined that a minimum mean change in % SPP of +10% or greater across the evaluation period would be considered clinically meaningful.~A positive (+) change indicates that SPP increased across the procedure administration phase and is positive for study efficacy.~A negative (-) change indicates that SPP decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks|||percentage of change||Standard Deviation|Mean
15625|NCT01882647|Other Pre-specified|Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population at Day 15 and compared to baseline. ITT was defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||Change in %BSA||Standard Deviation|Mean
15626|NCT01882647|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||units on a scale||Standard Deviation|Mean
15627|NCT01882647|Other Pre-specified|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8"|"Interim analysis of clinical signs of psoriasis. Treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||percentage of participants|||Number
15628|NCT01882647|Other Pre-specified|"Percentage of Subjects With IGA Treatment Success at Day 8"|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.||percentage of participants|||Number
15629|NCT01882647|Secondary|"The Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or average degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
15630|NCT01882647|Primary|"The Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|All subjects were classified into the following datasets: intent-to-treat (ITT), per protocol (PP), and safety populations. Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
15631|NCT01882465|Primary|Corneal Staining|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.|20 minutes and 7 hours post lens fitting|All subjects that completed every study visit without a major protocol deviation.||units on a scale|Subject Eyes|Standard Deviation|Mean
15642|NCT01882413|Primary|Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.|Up to 60 Days Prior to Surgery|Per-protocol population included all enrolled participants who completed all the study assessments without major protocol violations.||percentage of participants|||Number
15632|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15633|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15634|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Punctal Plugs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15635|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15636|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15637|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15638|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15639|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15640|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.||percentage of participants|||Number
15641|NCT01882413|Secondary|Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9|"Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of Yes to the Investigator Dry Eye History question."|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated data MMP-9 and data available for analysis.||percentage of participants|||Number
15643|NCT01882257|Other Pre-specified|Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing|Clinical features (neck and waist circumference, body mass index, level and duration of spinal cord injury, lung function tests, questionnaire results) will be analyzed to determine if certain attributes predict the presence or severity of sleep-disordered breathing.|Month 4 after enrollment||||||
15644|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism|When home-based sleep testing is performed, and at 3, 6, and 12 months afterward, subjects will have blood tests to determine if treatment of sleep-disordered breathing has any effects on glucose intolerance/diabetes and/or blood cholesterol/lipid levels|Months 4-16||||||
15645|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Quality of Life|At month 4 of the study, and every 3 months therafter for 12 months, the subjects will complete standardized questionnaires on quality of life, focusing on general well being, mood, pain, and sleepiness.|Months 4-16||||||
15646|NCT01882257|Other Pre-specified|Short Term Effects on Daily Symptoms and Medical Events|The subjects keep daily logs of certain symptoms and events (pulmonary symptoms that require escalated care, pulmonary infections, doctor visits, hospitalizations, antibiotic use, symptoms of unstable blood pressure). These data are collected throughout the study period|Months 0-16 after enrollment||||||
15647|NCT01882257|Primary|The Frequency of Technical Errors Related to the Home-based Overnight Testing.|All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).|Overnight testing (4-13 hours)|||participants|||Number
15648|NCT01882257|Primary|Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults|After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.|Month 4 after enrollment|||participants|||Number
15649|NCT01882062|Secondary|Correlation Between Primary Outcome Measure and Clinical Parameters|Correlating an improvement of brain energy profile with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).|visit 1 (baseline), visit 2 (after 1 month of treatment)||12/2015||||
15650|NCT01882062|Primary|Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr|"The Pi/PCr Ratio is a measure of brain metabolism and it is an index of mitochondrial oxidative regulation.~A 6-cm 31P transmit/receive surface coil (RAPID Biomedical GmbH, Rimpar, Germany) was used to collect free induction decays for 4 minutes at rest, 8 minutes during visual activation with 6-Hz red/black checkerboard flashes, and 8 minutes after stimulation. Subjects were able to focus on the flashes with a nonmagnetic mirror mounted above their eyes while all lights in the room were turned off. The Pi/PCr ratio was then calculated to determine brain response to cortical activation."|visit 1 (baseline), visit 2 (after 1 month of treatment)|||ratio||Standard Deviation|Mean
15651|NCT01881932|Primary|Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy.|The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.|Week 12|Zero participants analyzed due to early termination of study.|||||
15652|NCT01881776|Other Pre-specified|Total Hours of Sleep|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.|first postoperative week (on day 7)|||hours||Standard Deviation|Mean
15653|NCT01881776|Other Pre-specified|Time to Discharge Home|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.|throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)|||minutes||Standard Deviation|Mean
15654|NCT01881776|Other Pre-specified|Length of PACU Stay|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.|throughout the first postoperative week (how long patients stayed in PACU just after the operation)|||minutes||Standard Deviation|Mean
15655|NCT01881776|Other Pre-specified|Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate|throughout the first postoperative week (how many patients left PACU immediately just after the operation)|||participants|||Number
15656|NCT01881776|Secondary|The Number of Patients Consume ≥1 Dose of Analgesics|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).|throughout the first postoperative week|||participants|||Number
15657|NCT01881776|Secondary|Time-to-first Pain|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).|throughout the first postoperative week|||hours||Standard Deviation|Mean
15658|NCT01881776|Primary|Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4|The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)|throughout the first postoperative week on days 1, 2, 3, and 7|||participants|||Number
16031|NCT01871519|Secondary|Barthel Index (Only for Subjects With Osteoporosis)|For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).|30 days, 3 months 6 months, and 12 months|||units on a scale||Standard Deviation|Mean
15659|NCT01881126|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
15660|NCT01880840|Primary|Safety|"The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to <6 years of age with allergic rhinitis.~Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments.~Data for each age strata will be summarized separately as well as combined."|one month of treatment|||adverse events|||Number
15661|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|From week 16 to end of trial (week 27)|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
15662|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
15663|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|From Week 16 to end of trial (week 27)|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product. Subjects were grouped either according to dosing pattern or treatment algorithm received. 451 subjects contributed to the analysis. Subjects in the safety analysis set contributed to the evaluation “as treated”.||episodes|||Number
15664|NCT01880736|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition|Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
15665|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))|The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
15666|NCT01880736|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.||events|||Number
15667|NCT01880736|Secondary|Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial|The number of subjects who achieved the pre-defined HbA1c target (<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|After 26 weeks of treatment|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||Subjects|||Number
15668|NCT01880736|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Week 0, week 26|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||mg/dL||Standard Deviation|Mean
15918|NCT01874340|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|6 months|The safety set consists of all subjects who received at least one dose of study medication. Subjects will be analyzed according to the treatment received.||Participants|||Number
15669|NCT01880736|Primary|Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)|Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
15670|NCT01880723|Secondary|Peripheral Oxygen Saturation|A finger pulse oximeter allowed for the measurement of peripheral oxygen saturation at baseline, 30-, 60- and 90-minutes post albuterol in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol|||percent of oxygenated hemoglobin||Standard Deviation|Mean
15671|NCT01880723|Primary|Net Exhaled Chloride|"The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point:~Net Cl- efflux – [Cl- X-min post] + (([Na+ X-min post]-[Na+Baseline])/ [Na+Baseline]) x [Cl- X-min post])"|baseline to 90 minutes post albuterol administration|||mmol/L||Standard Deviation|Mean
15672|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Nitric Oxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration|||mL/min/mmHg||Standard Deviation|Mean
15673|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Carbon Monoxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration|||mL/min/mmHg||Standard Deviation|Mean
15674|NCT01880723|Primary|Exhaled Sodium (mmol/L)|We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration.|up to 90-minutes post albuterol|||mmol/L||Standard Deviation|Mean
15675|NCT01880697|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVc is reported.|Day 1 through Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.||Subjects|||Number
15676|NCT01880697|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIVc|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIVc are reported.|Day 1 to Day 4 post-vaccination|Analysis was done on the solicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.||Subjects|||Number
15677|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"The antibody responses following one dose of TIVc were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/day 1|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
15678|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVc.~Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer >10 to at least a 4-fold increase in post-vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40 % for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.||Percentages of Subjects||95% Confidence Interval|Number
15679|NCT01880697|Primary|Percentage of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.||Percentages of Subjects||95% Confidence Interval|Number
15680|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVc|The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVc The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years.|Day 22/day 1|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
15832|NCT01877720|Primary|Trigger Delay|Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.|last 5-min of each 15-min trial|||ms||Standard Deviation|Mean
15681|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVc.~Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.||Percentages of Subjects||95% Confidence Interval|Number
15682|NCT01880697|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study.||Percentages of Subjects||95% Confidence Interval|Number
15683|NCT01880437|Secondary|Area Under the Concentration-time Curve (AUC) of Cytarabine|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose, 0.25, 0.5, 1, 3, 6 hours post-dose on Days 1, 8 and 29|No participants were enrolled as the study was terminated prior to the initiation of Cohort 2.|||||
15684|NCT01880437|Secondary|Pharmacokinetics (PK): Steady-state Plasma Concentration of Vismodegib|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose on Days 8, 29 and 57|As the study was terminated prior to Cohort 2 enrollment, PK analysis could not be performed, as planned.|||||
15685|NCT01880437|Secondary|Percentage of Participants With an Event of Death During the Study||Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.||percentage of participants|||Number
15686|NCT01880437|Secondary|Median Overall Survival (OS) Time|OS was defined as the time from start of study drug to death from any cause. OS was estimated using Kaplan-Meier analysis. Participants alive at the last date known to be alive were censored for the analysis.|Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.||months||95% Confidence Interval|Median
15687|NCT01880437|Secondary|Duration of Overall Response (DOR)|DOR is defined as the time from the first occurrence of a documented overall response to the time of relapse, as determined by the investigator using International Working Group (IWG) criteria (Participants not falling under any of the response criteria [CR or CRi or MLFS or PR] described under outcome measure 1 were considered as non-responders) or death from any cause during the study (defined as death within 30 days after the last dose of study drug).|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy population including participants who were considered as responders.||weeks||95% Confidence Interval|Median
15688|NCT01880437|Secondary|Percentage of Participants With CR, CRi, MLFS or PR at Anytime During Study Treatment|CR was defined as achieved if the neutrophils count >1000 cells/µL, platelets count >100000/µL, bone marrow blasts <5%, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of EMD. CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils > 1000 cells/µL or NA or platelets count >100000/µL or NA, bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods. The 95% confidence intervals (CI) were constructed using Blyth-Still-Cassella method.|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population included all enrolled participants. Here “number of participants analyzed” included participants who were evaluable for tumor response at anytime during the study.||percentage of participants||95% Confidence Interval|Number
15689|NCT01880437|Primary|Percentage of Participants With a Complete Response (CR) or CR With Incomplete Blood Count Recovery (CRi) or Morphologic Leukemia Free State (MLFS) or Partial Response (PR) at Week 8|CR was defined as achieved if the neutrophils count was greater than (>) 1000 cells per microliter (µL), platelets count >100000/µL, bone marrow blasts percentage (%) less than (<) 5, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of extra medullary disease (EMD). CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils >1000 cells/µL or Not applicable [NA] or platelets count >100000/µL or NA), bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods.|Week 8|As the primary efficacy time-point (Week 8) was not reached for all participants due to study termination based on interim data analysis, the analysis of this outcome measure could not be performed, as per planned analysis.|||||
15690|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Discomfort|"The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period).~Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
15691|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Pain|"The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period).~Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
15692|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Bloating|"The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period).~Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
15693|NCT01880424|Secondary|Change From Baseline in 12-week Severity of Straining|"The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period).~Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount)."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale||Standard Error|Least Squares Mean
15694|NCT01880424|Secondary|Change From Baseline in 12-week Stool Consistency|"The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale [BSFS] score from the SBMs occurring during the 12-week Treatment Period).~Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts [difficult to pass] to 7=Watery, no solid pieces [entirely liquid])."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||Units on a Scale (BSFS)||Standard Error|Least Squares Mean
15695|NCT01880424|Secondary|Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period).~SBM is defined as a bowel movement without laxative use in the preceding 24 hours."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||SBMs per Week||Standard Error|Least Squares Mean
15696|NCT01880424|Secondary|Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period).~A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).||CSBMs per Week||Standard Error|Least Squares Mean
15697|NCT01880424|Primary|12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder|"A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was “Considerably relieved” or “Completely relieved”) for at least 6 out of the 12 weeks of the Treatment Period.~Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an IBS degree of relief score for a particular Treatment Period week, the patient was not considered a responder for that week.||Participants|||Number
15698|NCT01880424|Primary|12-week Abdominal Pain/Abdominal Discomfort Weekly Responder|"A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period.~Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain.~Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an abdominal pain score or abdominal discomfort score for a particular Treatment Period week, the patient was not considered a responder for that week.||Participants|||Number
15699|NCT01880320|Primary|Changes From Baseline in Non-Inflammatory Lesion Counts||Baseline - Week 12|ITT Population, Multiple Imputation||lesions||Standard Error|Least Squares Mean
15700|NCT01880320|Primary|Changes From Baseline in Inflammatory Lesion Counts||Baseline - Week12|ITT Population, Multiple imputation||Lesions||Standard Error|Least Squares Mean
15701|NCT01880320|Primary|Success Rate|"Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).~Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets."|Week 12|Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.||percentage of participants|||Number
16032|NCT01871519|Secondary|Ambulatory Status||baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months|||percentage of participants|||Number
15702|NCT01879852|Secondary|Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.||log (ng/mmol)||Standard Deviation|Mean
15703|NCT01879852|Secondary|Single Leg Forward Hop Index|Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100]|7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. 2 subjects in the Standard Rehabilitation group and 1 subject in the Standard + Quadriceps Intensive Strengthening group did not complete hop testing.||percentage||Standard Deviation|Mean
15704|NCT01879852|Primary|Change in Tibial Articular Cartilage Volume|A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.|Baseline (pre-surgery) to 1 year post-surgery|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. Images were not analyzable for one subject in the Standard+Quadriceps Intensive Strengthening group.||percentage change from baseline||Standard Deviation|Mean
15705|NCT01879852|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score|The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.||units on a scale||Standard Deviation|Mean
15706|NCT01879800|Secondary|Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up|"The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.~Each item is scored independently based on a five-point, ratio scale. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. Lastly, a score above 30 represents severe anxiety severity. The mean change in ratings will be assessed from baseline to 3 and 6 months follow up."|3- and 6- Month Follow-Up|||units on a scale||Standard Error|Mean
15707|NCT01879800|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale and at 3 and 6 month follow-ups.~Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|3-month and 6-Month Follow-Up|||units on a scale||Standard Deviation|Mean
15708|NCT01879800|Primary|Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up.|"The World Health Organization Quality of Life Measure- Physical scale assesses quality of life in physical health- specifically in activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, and Work Capacity. Outcome measure will be the change from baseline, at 3, and 6 months.~Each item ranges in score from 1-5. Individual items are rated on a 5 point Likert scale where 1 indicates low, negative perceptions and 5 indicates high, positive perceptions. As such, domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life.~The mean score of the items within this physical domain is used to calculate the overall physical domain score. Mean scores are then multiplied by 4, yielding a score of 4 to 20. A higher domain score indicates a higher quality of life in physical ability."|Change at 3 and 6- Month Follow-up|||units on a scale||Standard Error|Mean
15709|NCT01879735|Primary|Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar||All measurements are performed in one day.|||percentage of participants|||Number
15710|NCT01879722|Secondary|CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I|CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||mL/hour||Standard Deviation|Mean
15711|NCT01879722|Secondary|Fe: Fraction of Drug Excreted in Urine for TAK-063|Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||percent||Standard Deviation|Mean
15712|NCT01879722|Secondary|Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|Ae(0-24) is a measure of the total amount of study drug excreted in the urine from time 0 to 24 hours postdose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng||Standard Deviation|Mean
15738|NCT01879579|Other Pre-specified|Percentage of Successful Phone Calls|The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.||percentage of phone calls|Participants||Number
15713|NCT01879722|Secondary|Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24)|Accumulation ratios between Day 7 AUC(0-24) and Day 1 AUC(0-24), (Day 7/Day 1). Estimated Ratio (Day 7/Day 1) is the exponentiated results of the difference between Day 7 and Day 1 in log-transformed values which resolves to the ratio of Day 7/Day 1 estimates.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ratio||90% Confidence Interval|Mean
15714|NCT01879722|Secondary|AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24)|AUC(0-24) Ratio is the ratio of AUC(0-24) values of the metabolite compared to the parent calculated by dividing AUC(0-24) values of metabolite M-I with those of the parent drug TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ratio||Standard Deviation|Mean
15715|NCT01879722|Secondary|Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Molar Ratio is the ratio of Cmax molar values of the metabolite compared to the parent calculated by dividing Cmax molar values of metabolite M-I with those of TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ratio||Standard Deviation|Mean
15716|NCT01879722|Secondary|Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I|Cav is the Average plasma concentration on Day 1, calculated as AUC(0-24)/24 on Day 1. Cavss is the average plasma concentration on Day 7, calculated as AUC(0-24)/24 on Day 7.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants for whom PK data was available for analysis.||ng/mL||Standard Deviation|Mean
15717|NCT01879722|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||liter/hour||Standard Deviation|Mean
15718|NCT01879722|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng*hr/mL||Standard Deviation|Mean
15719|NCT01879722|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the Last Quantifiable Concentration.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng*hr/mL||Standard Deviation|Mean
15720|NCT01879722|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||hour||Full Range|Median
15721|NCT01879722|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.||ng/mL||Standard Deviation|Mean
15722|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
15723|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
15724|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
15725|NCT01879722|Primary|Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
15739|NCT01879579|Other Pre-specified|Percentage of Text Message Responses|The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.||percentage of text messages|Participants||Number
15740|NCT01879579|Secondary|Incidence of Hypoglycemia|The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.|12 weeks|This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild.||instances of hypoglycemia|||Number
15726|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28|The appearance of the Hunner’s lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 28|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.||percentage of participants|||Number
15727|NCT01879683|Secondary|Change From Baseline in Patient Reported IC Symptom: Daily Total Voids|The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement|Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.||voids||Standard Deviation|Mean
15728|NCT01879683|Secondary|Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain|Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.|Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.||score on a scale||Standard Deviation|Mean
15729|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14|The appearance of the Hunner’s lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 14|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.||percentage of participants|||Number
15730|NCT01879618|Secondary|Mean Percent of HD Sessions With an Acceptable Dose|A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.|20 HD sessions (up to 4 hours)|FAS was used for all efficacy analyses which included all participants who received at least one dose of study medication.||Percentage||95% Confidence Interval|Mean
15731|NCT01879618|Primary|Mean Percent of Successful HD Sessions|A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant’s blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.|20 HD sessions (up to 4 hours)|The Full Analysis Set (FAS) was used for all efficacy analyses which included all participants who received at least one dose of study medication.||Percentage||95% Confidence Interval|Mean
15732|NCT01879579|Other Pre-specified|Qualitative Patient Satisfaction Interview|The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.|After patient reaches optimal insulin dose or at 12 weeks||||||
15733|NCT01879579|Other Pre-specified|Costs - Co-pays|At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.|baseline|||participants|||Number
15734|NCT01879579|Other Pre-specified|Costs - Patient Travel Time|The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.|12 weeks|||minutes||Inter-Quartile Range|Median
15735|NCT01879579|Other Pre-specified|Costs - Titration Visit Information|The number of insulin titration visits (whether by phone or in the clinic).|12 weeks|Participants who completed the allocated intervention (and the participant who discontinued insulin early).||insulin titration visits||Inter-Quartile Range|Median
15736|NCT01879579|Other Pre-specified|Costs - Provider Time Spent on Insulin Titration Visits|Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.|12 weeks|Insulin titration visits with a duration recorded.||minutes|Participants|Inter-Quartile Range|Median
15737|NCT01879579|Other Pre-specified|Patient Healthcare Utilization|The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).|12 weeks|All participants.||hospital visits|||Number
15848|NCT01877148|Other Pre-specified|Change From Parkinson Disease Quality of Life - PDQL|"Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome), as accurate and appropriate"|at baseline, after 1 month|||units on a scale||Standard Error|Mean
15741|NCT01879579|Secondary|Change in Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.||score on satisfaction scale||Standard Deviation|Mean
15742|NCT01879579|Secondary|Treatment Satisfaction After Initiation of Insulin Titration|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.||score on satisfaction scale||Standard Deviation|Mean
15743|NCT01879579|Secondary|Baseline Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient’s satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|baseline|All participants who completed the treatment satisfaction questionnaire at baseline.||score on satisfaction scale||Standard Deviation|Mean
15744|NCT01879579|Secondary|Hemoglobin A1c|Change in hemoglobin A1c|baseline, 12 weeks (approximately 3 months)|All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks.||mg/dL||Standard Deviation|Mean
15745|NCT01879579|Secondary|Time to Reach Optimal Long-acting Insulin Dose|The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.|12 weeks|Participants who reached optimal long-acting insulin dose.||weeks||Inter-Quartile Range|Median
15746|NCT01879579|Primary|Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose||12 weeks|No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy.||percentage of participants|||Number
15747|NCT01879553|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one dose of TIV is reported.|Day 1 through Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data||Number of subjects|||Number
15748|NCT01879553|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination|||Number of subjects|||Number
15749|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV|"The antibody responses following one dose of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
15750|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
15751|NCT01879553|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
15752|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
15753|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (baseline)|Analysis was done on the per-protocol population||Percentages of subjects||95% Confidence Interval|Number
15754|NCT01879553|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIV .~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study||Percentage of subjects||95% Confidence Interval|Number
15755|NCT01879540|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age subjects reporting any unsolicited adverse event (AEs) between Day 1 to 4 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 22 after receiving one dose of aTIV are reported.|Day 1 to Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who had post-vaccination unsolicited AE records||Participants|||Number
15756|NCT01879540|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of aTIV are reported.|Day 1 to Day 4 post vaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records||Participants|||Number
15757|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of GMRs of post vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
15758|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in HI antibody titers after receiving one dose of aTIV.~Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer ≥10 to at least a 4-fold increase in post-vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >30% of subjects achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22|Analysis was done on the per-protocol population||Percentage of subjects||95% Confidence Interval|Number
15759|NCT01879540|Primary|Percentages of Subjects With Haemagglutinin Inhibition(HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV.|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the of subjects achieving HI titers ≥ 40 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population||Percentage of subjects||95% Confidence Interval|Number
15760|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of geometric mean ratio GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
15761|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in SRH area against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if>30% of subjects achieve seroconversion or significant increase in post-vaccination SRH area."|Day 22|Analysis was done on the per-protocol population||Percentage of subjects||95% Confidence Interval|Number
15762|NCT01879540|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.||Percentage of subjects||95% Confidence Interval|Number
15778|NCT01878825|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15849|NCT01877148|Secondary|Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation||per sesssion: at baseline and after physical therapy|||milivolt||Standard Error|Mean
15763|NCT01879410|Secondary|Change From Baseline(BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the 2 assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, day by baseline and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.||Liters||Standard Error|Least Squares Mean
15764|NCT01879410|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model with covariates of baseline FEV1 (mean of the two assessments made 30 mins and 5 mins pre-dose on Day 1), smoking status, and treatment. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all randomized participants who received at least 1 dose of randomized study drug in the Treatment Period. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information and with >= post BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
15765|NCT01879371|Secondary|AUC(0-inf)|AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
15766|NCT01879371|Primary|Cmax|Cmax: maximum measured concentration of Ibuprofen in plasma|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS||μg/mL||Geometric Coefficient of Variation|Geometric Mean
15767|NCT01879371|Primary|AUC(0-tz)|AUC(0-tz): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the last quantifiable data point|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|Pharmacokinetic set (PKS): included all treated subjects who provided at least one observation for at least one primary Pharmacokinetic endpoint without important protocol violations.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
15768|NCT01879345|Secondary|AUC0-τ|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7|||ng.h/mL||Standard Deviation|Mean
15769|NCT01879345|Secondary|Tmax - the Time of Occurrence of Cmax|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7|||hours||Standard Deviation|Mean
15770|NCT01879345|Secondary|Cmax - Maximum Observed Plasma Drug Concentration|"Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093~Oxcarbazepine is a BIA 2-093 metabolite"|Day 1 and Day 7|||ng/mL||Standard Deviation|Mean
15771|NCT01879345|Primary|Number of Adverse Events Reported|investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient|3 weeks|||Number of adverse events reported|||Number
15772|NCT01879332|Primary|Number of Adverse Events Reported|Safety was evaluated through the recording and monitoring of adverse events|2 days|||Number of adverse events reported|||Number
15773|NCT01879319|Secondary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
15774|NCT01879319|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8|Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.|Weeks 4 and 8|Full analysis set||Percentage of participants||95% Confidence Interval|Number
15775|NCT01879176|Primary|IL-6||1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours|||pg/ml||Inter-Quartile Range|Median
15776|NCT01879059|Primary|Effects of Physical Inactivity on Post Prandial Blood Flow|There was a pre-measurement period of 3 days, then 5 days of inactivity, followed by 1.5-2 days of return to activity. A 10 day time frame overall. Blood flow measured by Doppler ultrasound during an oral glucose tolerance test before and after 5 days of inactivity.|10 days|healthy, young, active men||percentage of change in blood flow||Standard Deviation|Mean
15777|NCT01878825|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Days 0-20 post vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15779|NCT01878825|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [oral temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15780|NCT01878825|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
15781|NCT01878825|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15782|NCT01878825|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
15783|NCT01878825|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15784|NCT01878825|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
15785|NCT01878825|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15786|NCT01878825|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
15797|NCT01878812|Secondary|Number of Days of Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.|During the entire study period (Days 0 to 21)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.||Days||Inter-Quartile Range|Mean
15787|NCT01878825|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
15788|NCT01878825|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
15789|NCT01878812|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Titers||95% Confidence Interval|Geometric Mean
15790|NCT01878812|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
15791|NCT01878812|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
15792|NCT01878812|Secondary|Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Titers||95% Confidence Interval|Geometric Mean
15793|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|At Days 0 and 21|||Subjects|||Number
15794|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|||Subjects|||Number
15795|NCT01878812|Secondary|Number of Days of Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.||Days||Inter-Quartile Range|Mean
15796|NCT01878812|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|||Subjects|||Number
15830|NCT01877720|Secondary|Minute Ventilation Volume|inspiratory tidal volume / respiratory rate|last 5-min of each 15-min trial|||mL/kg/min||Standard Deviation|Mean
15798|NCT01878812|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)|||Subjects|||Number
15799|NCT01878812|Primary|Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Percentage of subjects|||Number
15800|NCT01878812|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Fold increase||95% Confidence Interval|Geometric Mean
15801|NCT01878812|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
15802|NCT01878812|Primary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Subjects|||Number
15803|NCT01878812|Primary|Anti-HI Antibody Titers Against 4 Strains of Influenza Disease|The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.||Titers||95% Confidence Interval|Geometric Mean
15804|NCT01878799|Primary|Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)|The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.|12 weeks after completion of treatment|The analysis included all subjects who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
15805|NCT01878656|Other Pre-specified|Sense of Suffocation|The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.||||||
15806|NCT01878656|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.||||||
15807|NCT01878656|Secondary|The Time to Extubation|We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.||||||
15808|NCT01878656|Primary|The Incidence of Emergence Agitation Using Four-point Categorical Scale|The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.|||participants|||Number
15809|NCT01878214|Secondary|Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking|"At baseline and follow-up, subjects will answer questions about motivation to quit smoking (How motivated are you to quit smoking at this time? [scale: 1 (not at all) - 10 (extremely)]) and thinking about quitting smoking (Each rung on this ladder represents where various smokers are in their thinking about quitting. Circle the number that indicates where you are now. [0 (no thoughts of quitting) -10 (taking action to quit)]). We will report the % of subjects who reported more motivation to quit and greater thinking about quitting at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).||percentage of participants|||Number
16033|NCT01871519|Secondary|The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;||30 days, 3 months, 6 months, and 12 months|||days||Standard Deviation|Mean
15810|NCT01878214|Secondary|Changes in Readiness to Quit Smoking in the Next 6 Months|"Subjects will answer the following question at both baseline and follow-up surveys: Are you seriously considering quitting smoking in the next 6 months? [yes/no]. We will report % of subjects who said no at baseline and yes at follow-up to determine changes in readiness to quit smoking and compare between intervention and control groups."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).||percentage of participants|||Number
15811|NCT01878214|Secondary|Changes in Smoking Behaviors (Frequency and Quantity)|"At baseline and follow-up, subjects will report smoking frequency (How often do you smoke? [everyday, at least 4 days/week, 1-3 days/week, less than one day/week]) and quantity (On days that you smoke, how many cigarettes do you have per day? [10 or less, 11-20, 21-30, 31 or more]). We will report the % of subjects who smoke less frequently and smoke fewer cigarettes per day at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).||percentage of participants|||Number
15812|NCT01878214|Secondary|Quit Smoking|"At follow-up, subjects will report current smoking status. (Do you currently smoke (have you smoked in the last 30 days)? [Yes, I smoked within the past 30 days; No, but I have smoked in the past 6 months; No, and I have not smoked in more than 6 months]). We will report the % of subjects who have not smoked in the last 30 days and will compare the intervention group with the control group."|7 months after baseline|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey.||percentage of participants|||Number
15813|NCT01878214|Primary|Enrollment in Smoking Cessation Program|Enrollment records from the union-sponsored smoking cessation program|up to 12 months after recruitment|Includes all study subjects||participants|||Number
15814|NCT01878149|Secondary|Safety|Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.|Observed for up to 6 months post-surgery||||||
15815|NCT01878149|Primary|Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures|Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.|Observed for up to 6 months post-surgery|It was anticipated that approximately 40 subjects would be enrolled across the participating sites; 20 subjects in each treatment arm. Consecutive subjects who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the the data collection were included. The planned sample size was not statistically derived.||participants|||Number
15816|NCT01877941|Primary|Cardiac Output as Measured by ECOM|Measurements of cardiac output derived from the Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.|During and post-surgery, up to 8 hours|Supplies for the ECOM device were not available so it was not tested.|||||
15817|NCT01877941|Primary|PAC (Pulmonary Artery Catheter).|"Measurements of cardiac output derived from a PAC (pulmonary artery catheter) using the standard thermodilution technique. At each time point, at least 6 measurements were taken. If, in the opinion of the clinician taking the readings, some of these were in error, more readings were taken to ensure accuracy. In no case were more than 18 readings taken. The points deemed valid by the clinician were averaged to obtain the reference value for that time point. The mean and standard deviation reported consisted of the reference values from all time points measured.~Data for this test were taken at the following timepoints:~1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and post-surgery, up to 24 hours|||liters/minute||Standard Deviation|Mean
15818|NCT01877941|Primary|esCCO (Estimated Continuous Cardiac Output) Monitor|"6 Measurements of cardiac output derived from pulse oximeter measurements using the esCCO system were taken at each time point. The measurements deemed valid under the criteria in the protocol were averaged to represent the reference value at that point. The mean and standard deviation reported consist of the reference values from all time points measured.~Data for this test were taken at the following timepoints:~1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and after surgery, up to 24 hours|||liters/minute||Standard Deviation|Mean
15819|NCT01877720|Secondary|Respiratory Rate||last 5-min of each 15-min trial||||||
15820|NCT01877720|Secondary|Blood Pressure|systolic, diastolic and mean blood pressure measured by non-invasive cuff|last 5-min of each 15-min trial||||||
15821|NCT01877720|Secondary|Heart Rate||last 5-min of each 15-min trial||||||
15822|NCT01877720|Secondary|SpO2|transcutaneous peripheral saturation of oxygen by pulse oximeter|last 5-min of each 15-min trial||||||
15823|NCT01877720|Secondary|Asynchrony Index|"total number of each event per minute~ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization~auto-triggering: a cycle delivered by the ventilator without EAdi signal~premature cycling~delayed cycling: VPT > NIT x2~double triggering~Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100"|last 5-min of each 15-min trial|||percentage of neural respiration||Inter-Quartile Range|Median
15824|NCT01877720|Secondary|All Asynchrony Events||last 5-min of each 15-min trial|||events per min||Inter-Quartile Range|Median
15825|NCT01877720|Secondary|Leakage|[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)|last 5-min of each 15-min trial|||percentage of inspiratory tidal volume||Standard Deviation|Mean
15826|NCT01877720|Secondary|Swing EAdi||last 5-min of each 15-min trial|||uV||Standard Deviation|Mean
15827|NCT01877720|Secondary|Maximum EAdi||last 5-min of each 15-min trial|||uV||Standard Deviation|Mean
15828|NCT01877720|Secondary|Pneumatic Respiratory Rate||last 5-min of each 15-min trial|||breaths per min||Standard Deviation|Mean
15829|NCT01877720|Secondary|Peak Inspiratory Pressure||last 5-min of each 15-min trial|||cmH2O||Standard Deviation|Mean
15833|NCT01877538|Primary|Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE|"SUV values were calculated in 7 internal organs. SUV is a unitless ratio. We normalised to injected dose and bodyweight.~SUV (organ) = activity concentration (organ; kBq/mL) * bodyweight (mL) / injected dose (kBq)~Note: it is a common assumption when calculating SUV values that bodyweight equals volume, and therefore the unit mL is appropriate."|1 day (one timepoint)|In 6 subjects the SUV values in internal organs were calculated.||Unitless ratio||Standard Deviation|Mean
15834|NCT01877538|Primary|Distribution Volume (DV) of [11C]Donepezil - BASELINE|Logan's graphical analysis is used to calculate Distribution Volumes in Volumes of interest in internal organs (salivary gland, heart, liver, stomach, intestines, kidneys). Arterial blood sampling with radio metabolite correction is performed.|1 day (One timepoint)|In 6 subjects we analysed Volumes of distribution (Vd) and SUV values in internal organs (parotid, submandibular, spleen, stomach, heart, intestine, pancreas). NOTE: In subject number 7 we examined radioactive dose in 23 target organs (dose: microSv/MBq) and calculated the combined effective dose. The Vd and SUV values listed are from 6 subjects.||mL||Standard Deviation|Mean
15835|NCT01877408|Other Pre-specified|Number of Participants With Adverse Events|Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 year|||participants|||Number
15836|NCT01877408|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)|Within 6 weeks after surgery|||participants|||Number
15837|NCT01877408|Secondary|Overall Patient Satisfaction|"Patient satisfaction evaluated with questionnaire using satisfaction scale~Very satisfied~Satisfied~Not satisfied"|Within 6 weeks after surgery|||participants|||Number
15838|NCT01877408|Secondary|Pain Experienced|Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain|Within 2 days after surgery|||units on a 10-point pain scale||Standard Deviation|Mean
15839|NCT01877408|Secondary|Number of Participants With Complete Wound Healing by Post-Surgery Week 4||Within 4 weeks after surgery|||participants|||Number
15840|NCT01877408|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey based on 5 point Likert scale~Unicirc is much easier~Unicirc is easier~Neutral~Open surgical is easier~Open surgical is much easier"|1 year|The four physicians that participated in this study performed both procedures (i.e. open surgical and Unicirc) on study participants. Three physicians had significant previous (non-study) experience performing open surgical circumcisions. All four had no to very limited previous experience performing Unicirc circumcisions.||units on Likert scale||Full Range|Median
15841|NCT01877408|Primary|Intraoperative Duration|Amount of time from first manipulation of tissue under local anesthesia to dressing|1 hour|||minutes||Inter-Quartile Range|Median
15842|NCT01877343|Primary|Pulse Strength|Continuous change of pulse strength from baseline through the end of the study. Pulse strength is measured as volts by the system. Changes in pulse strength will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. Cardiac function curves will be constructed with the data collected and average pulse strength from baseline to 30 minutes will be reported.|Average pulse strength from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.|||||
15843|NCT01877343|Primary|Pulse Rate|Continuous change of pulse rate from baseline through the end of the study will be followed. Changes in pulse rate will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. From the graph, average pulse rate is calculated.|Average pulse rate from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.|||||
15844|NCT01877278|Primary|Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4|"Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis.~The WOMAC consists of 24 items divided into 3 subscales:~Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome."|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
15845|NCT01877278|Primary|Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4|visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
15846|NCT01877161|Primary|The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)|"Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus).~Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus.~The reaction time post TMS - reaction time pre TMS were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG"|change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)|||msec||Standard Deviation|Mean
15847|NCT01877148|Other Pre-specified|Change From Jebsen-Taylor Hand Function Test - Jebsen Test|The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function|At baseline, after 1 month|||minutes||Standard Error|Mean
15851|NCT01876823|Other Pre-specified|Conversion to Dementia Using Clinical Dementia Rating (CDR)|The CDR is a numeric rating scale that is used to quantify the severity of one's cognitive function. The scale goes from 0=normal; 0.5=mild cognitive impairment; 1 to 3=mild to moderate/severe dementia. CDR was used a dichotomous outcome measure (no=0; yes=1).|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).||participants|||Number
15852|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Cognitive Change|The CGI Cognitive Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses from the entire group were calculated. Mean at final visit and baseline is reported below.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).||units on a scale||Standard Deviation|Mean
15853|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Depression Change|The CGI Depression Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses were calculated for the entire group. Mean at final visit has been reported below. Higher mean at baseline indicates a decrease in depression scores.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).||units on a scale||Standard Deviation|Mean
15854|NCT01876823|Other Pre-specified|Change in Treatment Emergent Side Effects (TESS)|"Somatic side effect rating scale which includes 26 common somatic side effects associated with previous medication clinical trials; rated by the study physician. Factors were dichotomized to yes or no responses on this scale, which equated to the symptom being either present or not present. Yes and no responses were given a value of 0 (no) or 1 (yes). Responses from the entire group were calculated and the mean at baseline and the last visit is reported below."|Baseline, Week 48|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
15855|NCT01876823|Other Pre-specified|Change in 24-item HAMD|Change in 24-item Hamilton Rating Scale for Depression (HAMD) scores from baseline to Week 48: HAMD measures depression severity based on a series of 24 items items. The range of HAMD total score is 0-74; 0 indicates no depressive symptoms and a maximum HAMD score is a 74, where the greater the score indicates more significant psychopathology. In this study, moderate to severe depression is considered a HAMD-24 greater than 14.|Baseline, Week 48|Analysis was intent to treat.||scores on a scale||Standard Deviation|Mean
15856|NCT01876823|Secondary|Change in Trails A|Change in Trails A scores from baseline to Week 48: Measures attention and executive function. It asks patients to connect numbers from 1-25 in numerical order as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.||seconds||Standard Deviation|Mean
15857|NCT01876823|Secondary|Change in Trails B|Change from baseline to Week 48 on Trails B: Measures attention and executive function. It asks patients to connect numbers and letters in numerical to alphabetical order from (1-13 and A-L) as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers and letters, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.||seconds||Standard Deviation|Mean
15858|NCT01876823|Secondary|Change in Selective Reminding Test - Delayed Recall (SRT-DR)|Change in Selective Reminding Test-Delayed Recall scores from baseline to Week 48: SRT Delay is administered 15 minutes after the immediate recall portion. Patients are asked to remember as many of the words as they can from the 6 trials. Maximum raw score is a 12 for free recall. If a patient is unable to recall a word, they are given a chance to recognize it among three incorrect word choices. Maximum raw score for recognition is 12. The greater the score on the delayed recall portion, the better the patient does on the assessment.|Baseline, Week 48|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
15859|NCT01876823|Secondary|Change in Wechsler Memory Scale-III (WMS-III)|Change in Wechsler Memory Scale-III scores from baseline to Week 48: The WMS-III Visual Reproduction sub-test was used to measure visual working memory and delayed memory. Patients were shown pictures of four drawings and were asked to reproduce them from memory immediately after seeing them, and 25 minutes after seeing them. The four scores are summed and the greater the total raw score, the better the patient did on the assessment. The maximum raw score for this test is a 41 on both the immediate and delayed portions (the overall range is 0-82 points). The change score is calculated using the total scores of both the immediate and delayed portions.|Baseline, Week 48|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
15860|NCT01876823|Primary|Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)|Change in Selective Reminding Test-Total Immediate Recall (SRT-IR) scores from baseline to Week 48: Measures word recall (maximum 12 words per trial, across 6 trials). Maximum total recall score across 6 trials is 72; minimum recall is 0 across 6 trials. The higher the raw score, the better the patient did at recalling the target words. The unit of measure is the raw score, or the sum of the number of words recalled across all 6 trials.|baseline, 48 weeks|Analysis was intent to treat.||units on a scale||Standard Deviation|Mean
15883|NCT01876368|Secondary|Change From Baseline in Office Pulse Pressure|Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
15861|NCT01876732|Secondary|Change in Quality of Life|The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.|3 month|Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared.||Scores on a Scale||Standard Deviation|Mean
15862|NCT01876732|Primary|Change in Amount of Epogen Required|The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients|Baseline and 4 months|||unit/ml||Standard Deviation|Mean
15863|NCT01876706|Secondary|QMAX Median at Baseline and 12 Months With CI 95%|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.|12 Month|||mL/sec||95% Confidence Interval|Median
15864|NCT01876706|Secondary|IPSS at Baseline and 12 Months, Median , 95% CI|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.~Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Month|||IPSS total score Question 1-7||95% Confidence Interval|Median
15865|NCT01876706|Secondary|BPHII Baseline and 12 Month Median Score, 95% CI|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month|||BPHII total score||95% Confidence Interval|Median
15866|NCT01876706|Secondary|Pain Tolerability Throughout the UroLift System Procedure|Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.|12 Month|Pain Tolerability throughout the UroLift System Procedure||units on a scale||Full Range|Mean
15867|NCT01876706|Secondary|QMAX 12 Month Percent (%) Change in mL/Sec From Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 7 subject flows were either not valid or were not received.||100*(12 Months-baseline)||95% Confidence Interval|Mean
15868|NCT01876706|Secondary|QMAX 12 Month Change Minus Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 7 subject flows were either not valid or were not received.||mL/sec||Standard Deviation|Mean
15869|NCT01876706|Secondary|Qmax Scores at Baseline and 12 Month Follow-up|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.|12 Month|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.||mL/sec||Standard Deviation|Mean
15870|NCT01876706|Secondary|BPH II 12 Month Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months|||BPHII total score (Baseline - 12 Month)||Standard Deviation|Mean
15884|NCT01876368|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
15871|NCT01876706|Secondary|BPH II 12 Month Percent (%) Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months|||percentage of (Baseline - 12 Months/Base||95% Confidence Interval|Mean
15872|NCT01876706|Secondary|BPH II Scores at Baseline and 12 Month Follow-up|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month|||BPHII total score||Standard Deviation|Mean
15873|NCT01876706|Secondary|IPSS 12 Month Percent (%) Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.~The larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject."|12 Months|||percentage of (Baseline - 12 Months/Base||95% Confidence Interval|Mean
15874|NCT01876706|Secondary|IPSS 12 Month Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.~The larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS."|12 Months|||IPSS score baseline minus 12M||Standard Deviation|Mean
15875|NCT01876706|Secondary|IPSS Scores at Baseline and 12 Month Follow-up|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.~Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Months|||IPSS total score Question 1-7||Standard Deviation|Mean
15876|NCT01876706|Primary|Quality of Recovery|Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.|1 Month|||participants|||Number
15877|NCT01876368|Secondary|Number of Patients With Total Adverse Events, Serious Adverse Events and Death|Number of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization.||Number of participants|||Number
15878|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response|Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS||Participants|||Number
15879|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response|Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS||Participants|||Number
15880|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control|Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||Participants|||Number
15881|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control|Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||Participants|||Number
15882|NCT01876368|Secondary|Number of Patients Achieving Successful Overall Blood Pressure Control|Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS||Participants|||Number
15885|NCT01876368|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
15886|NCT01876368|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
15887|NCT01876368|Primary|Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis||mmHg||Standard Error|Least Squares Mean
15888|NCT01876329|Secondary|Presence of Anti-GPC Antibodies|Hypothesis: Evidence of anti-GPC Ab in a group of patients with RA will be more prevalent as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.|7 months|||participants|||Number
15889|NCT01876329|Primary|Prevalence of Vitamin B12 Deficiency|Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.|7 months|||participants|||Number
15890|NCT01875991|Secondary|Strength of Preference for Autoinjector A and Autoinjector B|Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8. After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).|Week 8|Primary Analysis Set||percentage of participants|||Number
15891|NCT01875991|Secondary|Pain Associated With Use of the Autoinjector|"Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject’s Experience with the Autoinjector Questionnaire: Using this scale, select the circle that best describes how much it hurt when giving yourself an injection. Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst). The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
15892|NCT01875991|Secondary|Satisfaction|"Satisfaction was assessed based on responses to questions 11 and 12 of the Subject’s Experience with the Autoinjector Questionnaire. Question 11: How dependable (durable, sturdy, reliable) did you feel the autoinjector device was? answered on a scale from 1 (Not at all) to 5 (Very much). Question 12: Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept? answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend). The percentage of participants who scored either a 4 or 5 on each question is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
15893|NCT01875991|Secondary|Discomfort|"Discomfort was assessed based on responses to Question 9 of the Subject’s Experience with the Autoinjector Questionnaire: How much discomfort did you experience when giving yourself the medicine using the autoinjector? Participants answered on a scale from 1 (None) to 5 (Very much). The percentage of participants who scored a 1 (None) or 2 (A little) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
15894|NCT01875991|Secondary|Convenience|"Convenience was assessed based on responses to Question 8 of the Subject’s Experience with the Autoinjector Questionnaire: How convenient was the autoinjector to use? Participants answered on a scale from 1 (Not at all) to 5 (Very much). The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
15895|NCT01875991|Secondary|Certainty of Completing the Injection With the Autoinjector|"Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject’s Experience with the Autoinjector Questionnaire: How certain were you that you knew when the injection was finished? Participants answered on a scale from 1 (Not at all) to 5 (Extremely). The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
15896|NCT01875991|Secondary|Ease of Use|Ease of use was assessed based on responses to questions 1 to 6 of the Subject’s Experience with the Autoinjector Questionnaire: 1. How easy was it to learn how to use the autoinjector? 2. How easy was it for you to press the button to start the injection? 3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection? 5. How easy was it for you to inject yourself using the autoinjector? 6. How easy was it to follow the progress of the injection? Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy). The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data||percentage of participants|||Number
15897|NCT01875991|Secondary|Change From Baseline in Needle Apprehension at Week 4|"Participants' needle apprehension was assessed using the Subject’s Perception of Self-Injecting Questionnaire. Participants answered the question Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector using a scale from 1 (extremely nervous) to 5 (not at all nervous)."|Baseline and Week 4|"Full analysis set, which included all randomized participants. n indicates the number of participants with available data."||units on a scale||Standard Deviation|Mean
15898|NCT01875991|Primary|Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B|"Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question Which autoinjector do you prefer overall?"|Week 8|The primary analysis set consisted of all randomized participants who received at least 1 injection of Eetanercept with each autoinjector and indicated a preference for an autoinjector in the Subject Preference Questionnaire. N = number of participants with RA and PsO respectively.||percentage of participants||95% Confidence Interval|Number
15899|NCT01875978|Primary|Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease|"Ceck serum endothelial progenitor cells in the monocytes group but not in the lymphocytes group. Serum EPCs in the monocytes group provide the effect of endothelial repair to support novel vessel protection.~Cytometry flow check 150,000 cells per time including monocytes and lymphocytes group. Positive cells is the EPCs in the monocytes group. Stain with KDR, call kinase insert domain receptor, also call as VEGF receptor-2.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||positive cells/150,000 cells||Standard Error|Mean
15900|NCT01875978|Primary|Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum Insulin-like growth factor-1 levels. Serum Insulin-like growth factor-1 (IGF-1) influence metabolic status and reduce EPCs apoptosis via IGF-1 receptor.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||ng/ml||Standard Error|Mean
15901|NCT01875978|Primary|Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease|"Check serum anti-oxidative capacity, especially the serum superoxide dismutase (SOD) levels.Serum SOD provide the anti-oxidative capacity in lipid oxidation.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||U/mg-protein||Standard Error|Mean
15902|NCT01875978|Primary|Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose~Check serum anti-inflammatory status: levels in C reactive protein~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day|||mg/dl||Standard Error|Mean
15903|NCT01875848|Secondary|Patient Global Impression of Change (PGIC)|"The Patient Global Impression of Change Scale (PGIC) is one question capturing the individual's overall perception of efficacy of treatment in a clinical trial. It uses verbal outcome categories on a 7-point scale with very much worse and very much better as anchors and no change in the middle. The verbal categories were coded on a scale with -3 very much worse,+3 very much better, and 0 same. To calculate the mean and standard deviation of each group (Bup/Opioid Increase) we took the sum of each participants final PGIC score and divided by the total number of participants."|12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.||units on a scale||Standard Deviation|Mean
15904|NCT01875848|Primary|Change in Numeric Rating Scale of Pain Severity|Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain level according to VHA treatment guidelines.|Baseline and 12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.||units on a scale||Standard Deviation|Mean
15905|NCT01875731|Secondary|Treatment Failure in Each Group|Number of participants with persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm. after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.|1, 2, 5, 7 and 10 days from baseline|||participants|||Number
15906|NCT01875731|Primary|Use of Antibiotics in Each Group|Number of participants with use of any antibiotic, at any time after diagnosis|At day 7 from baseline|||participants|||Number
15907|NCT01874665|Secondary|Pharmacokinetic (PK) Parameters of Steady-state Plasma Concentration|PK samples will be taken to assess limited elements of PK in the total patient population|Up to 1 month after the start of treatment||05/2017||||
15908|NCT01874665|Secondary|Safety|Measured by routine physical and laboratory evaluations, ECG, ECHO, and Adverse Event (AE) monitoring. To evaluate the safety and tolerability of ponatinib in the total patient population|From date of enrollment until the End-of-Treatment, assessed up to 3 years||05/2017||||
15909|NCT01874665|Secondary|Overall Survival (OS)|Defined as the interval between the first dose of study drug and death due to any cause, censored at the last contact date. To assess OS in each cohort and in the total patient population|From first dose of drug until the end of the study or death, whichever came first, assessed up to 3 years||05/2017||||
15910|NCT01874665|Secondary|Objective Response Rate (ORR)|Defined as the composite of CR and PR, assessed for each cohort and in the total patient population|From date of enrollment until discontinuation or the end of the study, whichever came first, assessed up to 3 years||05/2017||||
15911|NCT01874665|Secondary|Progression-free Survival (PFS)|Defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever may come first. To assess PFS in each cohort and in the total patient population|From date of enrollment until the end of the study or disease progression or death due to any cause, whichever came first, assessed up to 3 years||05/2017||||
15912|NCT01874665|Secondary|Clinical Benefit Rate (CBR) in Cohort B|To assess clinical benefit rate in patients with GIST that lacks KIT exon 11 mutations (Cohort B) and in the total patient population|16 weeks after first dose|||percentage (%) of participants||95% Confidence Interval|Number
15913|NCT01874665|Primary|Clinical Benefit Rate (CBR) in Cohort A|To assess clinical benefit rate in patients with KIT exon 11-mutant GIST. Defined as the composite of complete response (CR), partial response (PR), and stable disease (SD) lasting ≥16 weeks per modified RECIST 1.1 as a measure of disease control|16 weeks after first dose|||percentage (%) of participants||95% Confidence Interval|Number
15919|NCT01874340|Secondary|Change in Total Volume of T2-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Baseline, Month 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
15920|NCT01874340|Secondary|Combined Unique Active Lesions (CUAL)|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
15921|NCT01874340|Secondary|Annualized Relapse Rate|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|6 Months|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
15922|NCT01874340|Primary|Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.|||||
15923|NCT01874275|Other Pre-specified|Sleep Arousal Statistics Index at 365 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a decrease in the value between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour. Lower ASI values/numbers indicate improved sleep quality.|Baseline to 365 days||03/2015||||
15924|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant’s muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.|Baseline to 365 days|||percentage of change||Standard Deviation|Mean
15925|NCT01874275|Secondary|Percent Change in Percent Range of Motion From Baseline to 365 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.|Baseline to 365 days|||percentage of change||Standard Deviation|Mean
15926|NCT01874275|Other Pre-specified|Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a percent improvement between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour.|Baseline to 180 days|||percentage of change||Standard Deviation|Mean
15927|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, and 180 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant’s muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 180 days.|Baseline to 180 days|||percentage of change||Standard Deviation|Mean
15928|NCT01874275|Primary|Percent Change in Range of Motion From Baseline to 180 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90 and 180 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 180 days. Efficacy is defined as an increase in range of motion.|Baseline to 180 days|||percentage of change||Standard Deviation|Mean
15929|NCT01874262|Primary|Non-adherence Score|The primary composite endpoint was defined as a non-adherence score based on the combination of adherence failure events and treatment gaps. Adherence failure events were defined as 2 missed doses during an observation cycle of up to 7 days. The first registered missed dose of ticagrelor in the e-diary initiated an observation cycle of 1 week. If a second missed dose was registered during the week, this was considered an adherence failure event. The third missed dose initiated a new observation cycle, and the process restarted. If the second missed dose was registered after more than 1 week, this was not defined as an adherence failure event, but initiated a new observation cycle. Treatment gaps were defined as patient reported gaps of 4 consecutive doses.|6 months|||Non-adherence score||Standard Deviation|Mean
16034|NCT01871519|Secondary|Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks||30 days, 3 months, 6 months, and 12 months|||percentage of participants|||Number
15930|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
15931|NCT01874145|Primary|Injection-Related Adverse Events in the Extension Period|Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE||events|||Number
15932|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) – 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
15933|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
15934|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period||units on a scale||Standard Deviation|Mean
15935|NCT01874145|Secondary|Injection Site Reaction Events in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR).~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.||events|||Number
15936|NCT01874145|Secondary|Injection Site Reaction Event Rate Per Year in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.||events per year|||Number
15937|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) – 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
15947|NCT01874132|Primary|Cardiovascular Disease Risk Factors|"Bioelectrical impedance analysis to measure body fat percentage (%), fat-free mass (k) and dry lean mass (Kg).~Electronic sphygmomanometer to measure systolic blood pressure (mmHg) and diastolic blood pressure (mmHg).~Peripheral blood samples to collect serum lipid triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein cholesterol (mg/dL) and high-density lipoprotein cholesterol (mg/dL), and analyzed by enzymatic techniques."|one year|||percentage of participants|||Number
15948|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Ventricular Gradient|Compute maximum mean placebo, and baseline-adjusted change for: ventricular gradient (mV*ms).|24 hours|||mV*ms||95% Confidence Interval|Least Squares Mean
16035|NCT01871519|Secondary|Quality of Life by EQ-5D Index Score||30 days, 6 months, and 12 months|||units on a scale||Standard Deviation|Mean
15938|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) – 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
15939|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing over time.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 psychological score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
15940|NCT01874145|Primary|Injection-Related Adverse Event Rate Per Year in the Extension Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.~For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE||events per year|||Number
15941|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing over time.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 physical score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2, 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.||units on a scale||Standard Error|Mean
15942|NCT01874145|Secondary|Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient.~Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set||events per year||Standard Error|Mean
15943|NCT01874145|Other Pre-specified|Percentage of Participants With Adverse Events Other Than Injection Related Reactions During the Core Period and the Extension Period|An adverse event was defined in the protocol as any untoward medical occurrence in a patient that developed or worsened in severity during the conduct of the clinical study of a pharmaceutical product and did not necessarily have a causal relationship to the study drug. This outcome summarizes the % of participants who had AEs other than injection related reactions. Injection-related (IR) adverse events referring to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Day 1 to Month 4 (core period); Month 5 to 10 (extension period)|Safety analysis set||percentage of participants|||Number
15944|NCT01874145|Primary|Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.~For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient.~Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set||events per year||Standard Error|Mean
15945|NCT01874132|Other Pre-specified|Quality of Life|Measured by the Satisfaction With Life Scale.|One year||||||
15946|NCT01874132|Secondary|Physical Fitness|"Functional fitness was assessed according to the Fullerton Functional Fitness Test, and included 6 independent tests: 30-s chair stand (repetitions), arm curl (repetitions), chair sit-and-reach (cm), back scratch (cm), 8-foot up-and-go (s) and 6-min walk (m).~Falls risk was measured by the timed up-and-go test (seconds) and the functional reach test (cm)."|One year||||||
15950|NCT01873950|Secondary|Change in PR, QRS, J-Tpeak, Tpeak-Tend, QTc, Spatial QRS-T Angle and Ventricular Gradient Using Exposure/Response|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 90% CI) in QTc for the observed mean Cmax for each drug, highest individual concentration observed with the dose, and other appropriate concentrations pertaining to drug may be calculated."|24 hours||06/2016||||
15951|NCT01873950|Secondary|Change in Relationship Between Heart Rate and PR, QRS, J-Tpeak, Tpeak-Tend, QTc, Spatial QRS-T Angle and Ventricular Gradient|Different post-dose timepoints employ different techniques for altering heart rate (leg raises and postural maneuvers). Using this data a model for different ECG parameters (same as for primary analysis) and heart rate will be developed. The model will either be a linear or non-linear model (as determined by visual inspection), but the model will be the same for all subjects and maneuvers. The model coefficients for different maneuvers and drugs will be compared.|24 hours||06/2016||||
15952|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in PR, QRS, J-Tpeak, Tpeak-Tend and QTc|Compute maximum mean placebo, and baseline-adjusted change for: PR (ms), QRS (ms), J-Tpeak (ms), Tpeak-Tend (ms) and QTc (ms)|24 hours|||ms||95% Confidence Interval|Least Squares Mean
15953|NCT01873859|Primary|Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.||48 hours from the baseline|||mg/dl||Standard Deviation|Mean
15954|NCT01873859|Primary|Incidence of Lactic Acidosis|Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.|48 hrs|||participants|||Number
15955|NCT01873729|Secondary|Clinical Global Impression (CGI)|The Clinical Global Impression (CGI) scale allows the clinician to rate the severity of illness, change over time, and efficacy of medication, taking into account the patient’s clinical condition and the severity of side effects. The CGI subscales include the Clinical Global Severity of ADHD (CGI-S) which is scored on a 7 point scale (1=not ill, 7=extremely ill) and the Clinical Global Improvement of ADHD (CGI-I) which is also scored on a 7 point scale (1=very much improved, 7=very much worse). The number of subjects with CGI-Improvement scores less than or equal to 2 (very much improved) at the end of the study is reported.|Six weeks|||Participant|||Number
15956|NCT01873729|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline|The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms).|Baseline and Six weeks|||Units on a scale||Standard Deviation|Mean
15957|NCT01873417|Secondary|Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy|The last symptomatic therapy prior to last dose of study medication was used to summarize the number of participants who discontinued DMF due to GI-related events. Participants may have taken more than one symptomatic therapy but are counted only once in the 'All Therapies' category.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||participants|||Number
15958|NCT01873417|Secondary|Summary of Use and Days on Symptomatic Therapy, by Category|The total duration (in days) of use of each symptomatic therapy by participants as a result of GI symptoms experienced by DMF-treated participants is presented. If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in the 'All Therapies' category.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]). n= number of participants using the therapy specified.||days||Standard Deviation|Mean
15959|NCT01873417|Secondary|Participants' Use of Symptomatic Therapy, by Type and Category|The symptomatic therapies used by DMF-treated participants were self-reported by type and category. Each participant may have taken more than one symptomatic therapy type but was counted only once within each therapy category. Acetylsalicylic acid (ASA) is abbreviated in the table.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||participants|||Number
15960|NCT01873417|Secondary|Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy|Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||percentage of participants|||Number
15961|NCT01873417|Primary|Duration of GI-related Episodes in DMF-treated Participants|In participants who took symptomatic therapy, the median duration of acute GI episodes (in hours) was summarized for the overall treatment period, by symptom (nausea, diarrhea, lower abdominal pain, upper abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence). Table only includes the symptom duration for those symptoms with start and stop times entered in the eDiary (evaluable GI episodes), based on the MAGISS.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]); n=number of participants with evaluable GI symptom specified.||hours||Full Range|Median
15962|NCT01873417|Primary|Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy|Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)||percentage of participants|||Number
15963|NCT01873417|Primary|Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale|Severity of GI-related events in DMF-treated participants using the MAGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).||units on a scale||Standard Deviation|Mean
15964|NCT01873417|Primary|Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)|Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).||units on a scale||Standard Deviation|Mean
17291|NCT01835912|Primary|Time|"time to complete 200 metre swimming performances in seconds~Participants chose type of swim stroke to swim a maximal effort 200 metre performance"|once each 200m performance|||seconds||Standard Error|Mean
15966|NCT01872715|Secondary|Patient Global Assessment (PGA) of Rosacea Scores|Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules|Baseline, Weeks 2, 6, and 12|||participants|||Number
15967|NCT01872715|Secondary|Rosacea-Specific Quality of Life Index|ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.||units on a scale||Standard Deviation|Mean
15968|NCT01872715|Primary|Rosacea Score on the Visual Analog Scale|VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.||units on a scale||Standard Deviation|Mean
15969|NCT01872611|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
15970|NCT01872611|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
15971|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set||Percentage of participants|||Number
15972|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set||Percentage of participants|||Number
15973|NCT01872611|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set||Percentage of participants|||Number
15974|NCT01872611|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set||Percentage of participants|||Number
15975|NCT01872078|Primary|Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7|Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7|Day 7|||Ratio||95% Confidence Interval|Geometric Mean
15976|NCT01871870|Secondary|Deviation From Target Blood Glucose|Assessment of how accurately the algorithm controls glycemia in the subjects will be carried out using the mean deviation from the target blood glucose (mg/dL). Deviation is measured as algorithm controlled glucose level minus target glucose level.|28 hours|||mg/dl||Standard Deviation|Mean
15977|NCT01871870|Primary|Verification of the Automation and Telemetry Components|This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.|28 hours|||failures||Standard Deviation|Mean
15978|NCT01871805|Secondary|Change From Baseline in EORTC QLQ-LC13: Phase II|EORTC QLQ-LC13: consisted of 13 questions with one symptom scale for dyspnea of 3 items and 10 single items (cough, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain, pain medication). Questions used 4-point scale (1 'Not at all' to 4 'Very much'. Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, last visit (Week 60; data cutoff date of 24 October 2014)|Safety Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure. Here, n = number of participants available for the analysis at specified timeframe for this outcome measure.||units on a scale||Standard Deviation|Mean
15979|NCT01871805|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 ‘Not at all’ to 4 ‘Very much’; 2 questions used 7-point scale [1 ‘very poor’ to 7 ‘Excellent’]). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning or greater degree of symptoms and lower score indicates lower level of that particular symptom.|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, last visit (Week 60; data cutoff date of 24 October 2014)|Safety Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure. Here, n = number of participants available for the analysis at specified timeframe for this outcome measure.||units on a scale||Standard Deviation|Mean
15980|NCT01871805|Secondary|Ctrough After Multiple Dose of Alectinib: Phase II||Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure. Here, n = number of participants available for the analysis at specified timeframe in specified group.||ng/mL||Standard Deviation|Mean
15981|NCT01871805|Secondary|AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
16036|NCT01871519|Secondary|Quality of Life by SF-36v2 PCS|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|30 days, 6 months, and 12 months|||units on a scale||Standard Deviation|Mean
15982|NCT01871805|Secondary|Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I|AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf). AUC is expressed in hour*ng/mL.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
15983|NCT01871805|Secondary|Cmax After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1|PK Evaluable Population. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||ng/mL||Standard Deviation|Mean
15984|NCT01871805|Secondary|Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I|Cmax was expressed in nanograms per milliliter (ng/mL).|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3|Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. Here, number of participants analyzed = participants available for the analysis for this outcome measure.||ng/mL||Standard Deviation|Mean
15985|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RANO by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RANO criteria . As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease).|Every 6 weeks from Cycle 1 Day 1 at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cutoff date of 24 October 2014)|Safety Population in Phase II.||percentage of participants|||Number
15986|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST 1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety Population in Phase II.||percentage of participants|||Number
15987|NCT01871805|Secondary|CDOR According to RANO by IRC: Phase II|CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 15. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)||09/2017||||
15988|NCT01871805|Secondary|CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II|CDOR was defined for CNS responders as the time from the first observation of a CNS response of CR or PR until first observation of CNS progression or death from any cause. An analysis by IRC using RECIST v1.1 was performed. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)||09/2017||||
15989|NCT01871805|Secondary|Percentage of Participants With COOR According to Response Assessment in Neuro-Oncology (RANO) by IRC: Phase II|CORR was defined as the proportion of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper and Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety population. Here number of participants analyzed = participants with measurable CNS lesions at baseline based on RANO according to IRC.||percentage of participants||95% Confidence Interval|Number
15990|NCT01871805|Secondary|Percentage of Participants With Central Nervous System Objective Response Rate (CORR) Among Participants With Measurable Central Nervous System Lesions at Baseline According to RECIST v1.1 by IRC: Phase II|CORR was defined as the proportion of participants who had a CR or PR of the baseline CNS lesions, based on RECIST v.1.1. CNS responses according to RECIST v1.1 did not have to be confirmed. Refer “Outcome Measure 2” for the definition of CR and PR. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety population. Number of participants analyzed = participants with measurable CNS lesions at baseline based on RECIST according to IRC.||percentage of participants||95% Confidence Interval|Number
20564|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
15991|NCT01871805|Secondary|DOR Assessed by Investigator: Phase II|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression according to RECIST 1.1 or death (whichever occurred first). Participants who did not progress or did not die after they had a confirmed response were censored at the date of their last tumor measurement. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Investigator RE Population who had best overall response of CR or PR were included for analysis.||months||95% Confidence Interval|Median
15992|NCT01871805|Secondary|DOR Assessed by IRC: Phase II|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression according to RECIST 1.1 or death (whichever occurred first). Participants who did not progress or did not die after they had a confirmed response were censored at the date of their last tumor measurement. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|IRC RE Population who had best overall response of CR or PR were included for analysis.||months||95% Confidence Interval|Median
15993|NCT01871805|Secondary|Overall Survival (OS) Time: Phase II|OS was defined as the time between date of first dose and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants without any follow up information were censored at the date of first dose. OS curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to death (any cause) (data cutoff 24 October 2014, maximum follow up 60 weeks)|Safety Population||months||95% Confidence Interval|Median
15994|NCT01871805|Secondary|PFS by Investigator: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST 1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|RE Population||months||95% Confidence Interval|Median
15995|NCT01871805|Secondary|Percentage of Participants With Disease Progression or Death by IRC: Phase II|Participants who have neither progressed according to RECIST 1.1 nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety Population||percentage of participants|||Number
15996|NCT01871805|Secondary|Progression-Free Survival (PFS) by IRC: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST 1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS curves and the median time to the event was estimated using the methodology of Kaplan and Meier and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Safety Population||months||95% Confidence Interval|Median
15997|NCT01871805|Secondary|Percentage of Participants With Disease Control by Investigator: Phase II|Disease control rate assessed according to RECIST 1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. 95% CI for rates were constructed using Clopper-Pearson method.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|RE Population comprised all participants with measurable disease at baseline according to the investigator who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
41614|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban After Three Days of 15 mg IV Daily in HRS Type 1 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
15998|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II|The objective response rate was defined as the proportion of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST 1.1 criteria. Refer “Outcome Measure 2” for the definition of CR and PR. CR and PR were to be confirmed by repeat assessments ≥4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1 at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|RE Population comprised all participants with measurable disease at baseline according to the investigator who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
15999|NCT01871805|Secondary|Duration of Response (DOR) Assessed by Investigator: Phase I|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST 1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a CR were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. DOR curves and the median time to the event was estimated using the methodology of Kaplan and Meier and Brookmeyer and Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 105; data cut-off date 24 October 2014)||09/2017||||
16000|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I|The objective response rate was defined as the proportion of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. Refer “Outcome Measure 2” for the definition of CR and PR. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 105; data cut-off date 24 October 2014)|RE Population comprised all participants with measurable disease at baseline according to the investigator who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
16001|NCT01871805|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II|The objective response rate assessed by IRC was defined as the proportion of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST 1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments ≥4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to Week 60; data cut-off date 24 October 2014)|Response Evaluable (RE) Population comprised all participants with measurable disease at baseline according to the IRC who had a baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
16002|NCT01871805|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) - Phase I|The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of >=7 days which the Investigator could not rule out as been related to alectinib.|Cycle 1 of Phase I (21 days)|Safety Population||participants|||Number
16003|NCT01871558|Secondary|Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline)|HbA1c <= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain|week 24|ITT population||percent of participants|||Number
16004|NCT01871558|Secondary|Percentage of Patients With Severe and Confirmed Hypoglycemic Events|Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) < 70 mg/dL|24 weeks|ITT population||percent participants|||Number
16005|NCT01871558|Secondary|Mean Daily Insulin Dose at Week 24||Week 24|ITT population||(U/d)||Standard Deviation|Mean
16006|NCT01871558|Secondary|Change From Baseline in Body Weight in Both Treatment Arms||Baseline, Week 24|Safety Population||kg||Standard Deviation|Mean
16007|NCT01871558|Secondary|Change From Baseline in HbA1c to Week 24 in Both Treatment Arms||Baseline, Week 24|ITT population||HbA1c percent||Standard Deviation|Mean
16008|NCT01871558|Secondary|Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events|Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%|24 weeks|ITT population||percent of participants|||Number
16009|NCT01871558|Primary|Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms||24 weeks|safety population||percent of participants|||Number
16010|NCT01871532|Secondary|Sex Hormone Binding Globulin (SHBG) Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16011|NCT01871532|Secondary|Testosterone Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16015|NCT01871532|Secondary|Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS was defined as an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations, classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications.|up to 42 days post hCG administration|Safety population included all subjects who were randomised and received at least 1 Gonal-f injection.||subjects|||Number
16016|NCT01871532|Secondary|Number of Miscarriages After Confirmation of Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, and clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or confirmed by clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16017|NCT01871532|Secondary|Number of Fetuses||35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16018|NCT01871532|Secondary|Number of Multiple Pregnancy|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16019|NCT01871532|Secondary|Percentage of Cycles Resulting in Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16020|NCT01871532|Secondary|Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16021|NCT01871532|Secondary|Percentage of Ovulatory Cycles|Ovulation was defined as a serum progesterone (P4 ) level greater than or equal to 10 nanogram per milliliter (ng/mL) or Clinical Pregnancy. Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16022|NCT01871532|Secondary|Percentage of Cycles With Multifollicular Development|The multifollicular development was defined as the number of cycles with multifollicular development of three or more follicles greater than or equal to 14 millimeter|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16023|NCT01871532|Secondary|Percentage of Cycles With Bifollicular Development|The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 millimeter.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16024|NCT01871532|Primary|Percentage of Cycles With Monofollicular Development|The monofollicular development was defined as the number of cycles with monofollicular development only one Follicle Greater Than or Equal (>= to 17 millimeter (mm) and no other follicles Greater than or equal to 14 mm following up to 4 weeks Gonal-f treatment.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.|||||
16025|NCT01871519|Secondary|Neurological Success Rate|Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.|Pre-discharge, 30 days, 3 months, 6 months, and 12 months|||percentage of participants|||Number
16026|NCT01871519|Secondary|Subsequent Radiographic Fractures|A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.|3 months and 12 months|||percentage of participants|||Number
16027|NCT01871519|Secondary|Local Cobb Angle|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in LCA analysis.||degrees|Treated levels|Standard Deviation|Mean
16028|NCT01871519|Secondary|Vertebral Body Angle|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in VBA analysis.||degrees|Treated levels|Standard Deviation|Mean
16029|NCT01871519|Secondary|Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)|AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.|Pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis.||percentage of pre-fracture height|Treated levels|Standard Deviation|Mean
16030|NCT01871519|Secondary|Karnofsky Performance Scale|For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.|30 days, 3 months 6 months, and 12 months|||units on a scale||Standard Deviation|Mean
16037|NCT01871519|Secondary|Back Function (ODI)|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|30 days, 6 months, and 12 months|||units on a scale||Standard Deviation|Mean
16038|NCT01871519|Secondary|Back Pain|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|7 days, 30 days, 6 months, 9 months, and 12 months|||units on a scale||Standard Deviation|Mean
16039|NCT01871519|Primary|Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|3 months after surgery|||units on a scale||Standard Deviation|Mean
16040|NCT01871519|Primary|SF-36v2 Physical Component Summary Change From Baseline at 3 Months|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|3 months after surgery|||units on a scale||Standard Deviation|Mean
16041|NCT01871519|Primary|Back Function Change From Baseline by Oswestry Disability Index at 3 Months|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|3 months after surgery|||units on a scale||Standard Deviation|Mean
16042|NCT01871519|Primary|Back Pain Change From Baseline at 3 Months|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|3 months after surgery|||units on a scale||Standard Deviation|Mean
16043|NCT01871402|Other Pre-specified|Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject’s palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Baseline, Day 8 and Day 15|Analysis shown is based on the ITT population at Days 8 and 15 and compared to baseline. Number of Participants Analyzed is at Day 15; at Day 8, N=109 (Active) and N=110 (Vehicle). Only participants with observed values are reported.||Change in %BSA||Standard Deviation|Mean
16044|NCT01871402|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject’s pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the ITT population. Only participants with observed values are reported.||units on a scale||Standard Deviation|Mean
16045|NCT01871402|Other Pre-specified|Proportion of Subjects Rated a “Treatment Success” for Each of the Clinical Signs of Psoriasis at Day 8|"Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). Treatment success and clinical signs as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.||percentage of participants|||Number
16046|NCT01871402|Other Pre-specified|Proportion of Subjects With IGA “Treatment Success” at Day 8|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.||percentage of participants|||Number
16047|NCT01871402|Secondary|"Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or “average” degree of severity of each of three key characteristics present within all of the subject’s psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the ITT population.||percentage of participants|||Number
16048|NCT01871402|Primary|"Proportion of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
16049|NCT01871285|Primary|Change From Baseline in Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.||score||Standard Deviation|Mean
16050|NCT01871285|Primary|Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 periods); 4 subjects were excluded.||score||Standard Deviation|Mean
16051|NCT01871285|Secondary|Change From Baseline in “Pain Now” Over Time Using NRS|Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine.|Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects excluded.||units on a scale||Standard Deviation|Mean
16052|NCT01871285|Secondary|Change From Baseline in COWS Total Score Over Time|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.||score||Standard Deviation|Mean
16053|NCT01871285|Primary|Number of Responders|A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects were excluded.||participants|||Number
16054|NCT01871142|Secondary|Secondary Objective Safety and Tolerability|To assess the safety and tolerability of single, escalating oral doses of Aes-103 compared with placebo in healthy adult men at rest and during stationary cycle ergometer exercise in normoxia and hypoxia by monitoring adverse events (AEs), electrocardiograms (ECGs), blood pressure, blood oxygen saturation.|AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.|||participants|||Number
16055|NCT01871142|Primary|Primary Objective Endurance Exercise Performance|To quantify endurance exercise performance (time trial performance during stationary cycle ergometer exercise) in healthy adult men in four conditions: normoxia (normal oxygen; fraction of inspired oxygen = 0.21) following oral placebo consumption, hypoxia (low oxygen; fraction of inspired oxygen = 0.15) following oral placebo consumption, hypoxia following oral consumption Aes-103 (1000 mg) and hypoxia following oral consumption Aes-103 (3000 mg).|The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.|||minutes||Standard Error|Mean
16056|NCT01871090|Other Pre-specified|Length of Emergency Department Stay|Defined as the time from the Emergency Department Check In Time until the Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission|||Minutes||Full Range|Median
16057|NCT01871090|Secondary|Time to Clinical/Treatment Decision|Defined as the time from the Emergency Department Check In Time until the first of: Time of Clinical/Treatment Decision or Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission|||Minutes||Full Range|Median
16058|NCT01871090|Primary|Time to Interrogation|Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.|On day of Emergency Department admission|||Minutes||Full Range|Median
16059|NCT01870999|Secondary|"Number of Participants Hospitalized for Adverse Event Worsening Schizophrenia"|The number of participants hospitalized for the Adverse Event “Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms.|7 Months|All randomized participants were included in the analysis population.||Participants|||Number
16060|NCT01870999|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available at the given time-point were included in this analysis population.||units on a scale||Standard Deviation|Mean
16061|NCT01870999|Secondary|Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).||units on a scale||Standard Deviation|Mean
16062|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24|The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).||units on a scale||Standard Deviation|Mean
16063|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24|The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).||units on a scale||Standard Deviation|Mean
16064|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population-last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
16065|NCT01870999|Secondary|Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||Day||Full Range|Median
16066|NCT01870999|Secondary|Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||μg*h/mL||Standard Deviation|Mean
16067|NCT01870999|Secondary|Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||ng/mL||Standard Deviation|Mean
16068|NCT01870999|Secondary|Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.||ng/mL||Standard Deviation|Mean
16069|NCT01870999|Secondary|Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. The analysis population for this outcome measure represents a sub-set who were evaluable for this measure at month 5.||Day||Standard Deviation|Mean
16070|NCT01870999|Secondary|Aripiprazole Steady-state Plasma Concentration (Css,Avg)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.||ng/mL||Standard Deviation|Mean
16071|NCT01870999|Secondary|Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.||Day||Full Range|Median
16106|NCT01869686|Secondary|Ratio of Maximum Seminal Fluid Concentration by the Serum Concentration (Cmax Ratio)|The ratio of maximum denosumab seminal fluid concentration over the denosumab serum concentration at the corresponding time point (Cmax Ratio)|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data||ratio||Standard Deviation|Mean
16404|NCT01856686|Secondary|Inattention Score|Inattention assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome.|3 months|||units on a scale||Standard Deviation|Mean
16072|NCT01870999|Primary|Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.||μg*h/mL||Standard Deviation|Mean
16073|NCT01870999|Primary|Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.|672 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 200 mg Aripiprazole IM Depot arm.||ng/mL||Standard Deviation|Mean
16074|NCT01870999|Primary|Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.||ng/mL||Standard Deviation|Mean
16075|NCT01870999|Primary|Number of Participants With Adverse Events as a Measure of Safety|Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.|7 Months|Participants who received at least one dose of study medication are included in the safety analysis set.||Participants|||Number
16076|NCT01870973|Primary|Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use|"pain measurement as assessed on a visual analog scale and pain medication usage~definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression~VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success."|each day for 5 days|||percentage of participants|||Number
16077|NCT01870921|Secondary|Major CV Events|Combination of CV death, MI, and stroke|12 months|||Participants|||Number
16078|NCT01870921|Primary|Serious Adverse Events Other Than Bleeding|SAEs except the blending events which have aleady been reported as SAEs.|12 months|||Participants|||Number
16079|NCT01870921|Primary|Bleeding Events|PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal|12 months|||Participants|||Number
16080|NCT01870856|Secondary|Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2||||||
16081|NCT01870856|Primary|Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2||||||
16082|NCT01870856|Primary|Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.|Baseline, Week 2|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points.||percentage of subjects|||Number
16083|NCT01870843|Secondary|Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method.|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
16084|NCT01870843|Secondary|Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
16139|NCT01868074|Primary|Change in Arch Drop|Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System|baseline, 8 weeks postpartum|||mm||Standard Error|Mean
16085|NCT01870843|Secondary|Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
16086|NCT01870843|Secondary|Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms.|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.||Units on a scale||95% Confidence Interval|Mean
16087|NCT01870843|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.||Units on a scale||95% Confidence Interval|Mean
16088|NCT01870843|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56|"The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and it ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.||Units on a scale||95% Confidence Interval|Mean
16089|NCT01870843|Secondary|Treatment Improvement Rate at the End of Week 1 and Week 2|"Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Week 1 and Week 2|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Participants|||Number
16090|NCT01870843|Secondary|Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Percentage of participants||95% Confidence Interval|Number
16091|NCT01870843|Primary|Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56|"SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from 0 = unimpaired to 30 = highly impaired. Higher scores indicate worsening."|Baseline, Day 14, Day 28, Day 42, and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Units on a scale||Standard Deviation|Mean
16103|NCT01870596|Primary|Response Rate(CR/CRi) Rate|For descriptive purposes, the CR/CRi (complete response/Complete response with incomplete blood count recovery) rate will be reported at the end of the study separately for Arm A and Arm B. Responses are following definitions consistent with those published by Dohner H, Estey EH, Amadori S, et al. CR is defined as Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blasts in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. CRi: All CR criteria except for residual neutropenia (ANC < 1000/μL)|Up to 3 years|||participants|||Number
16092|NCT01870843|Primary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56|"Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening."|Baseline, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."||Units on a scale||Standard Deviation|Mean
16093|NCT01870739|Secondary|Number of Patients With Reported Adverse Events, Serious Adverse Events and Death|This outcome measure summarizes patients with any adverse events, serious adverse events and death.|12 weeks|Safety analysis set: All patients that received study drug||Patients|||Number
16094|NCT01870739|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks|For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis||meters per second (m/s)||Standard Error|Least Squares Mean
16095|NCT01870739|Secondary|Change From Baseline in Augmentation Index at 52 Weeks|Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis||percent||Standard Error|Least Squares Mean
16096|NCT01870739|Secondary|Change From Baseline in Augmentation Pressure at 52 Weeks|Augmentation pressure is the added pressure during systole due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||mmHg||Standard Error|Least Squares Mean
16097|NCT01870739|Secondary|Change From Baseline in Central Blood Pressure at 52 Weeks|Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||mmHg||Standard Error|Least Squares Mean
16098|NCT01870739|Secondary|Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||meters per second (m/s)||Standard Error|Least Squares Mean
16099|NCT01870739|Secondary|Change From Baseline in Local Aortic Strain at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||percent||Standard Error|Least Squares Mean
16100|NCT01870739|Primary|Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
16101|NCT01870739|Primary|Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
16102|NCT01870739|Primary|Change From Baseline in Ascending Aorta Distensibility at 52 Week|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
16104|NCT01869686|Secondary|Ratio of Denosumab Seminal Fluid Concentration Over the Denosumab Serum Concentration at the Last Study Time Point (Day 106).||Day 106|Pharmacokinetic population with available data||ratio||Standard Deviation|Mean
16105|NCT01869686|Secondary|Ratio of Seminal Fluid AUC by Serum AUC for the 106 Day Dosing Period|The ratio of denosumab seminal fluid AUC over denosumab serum AUC for the 106-day dosing period.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||ratio||Standard Deviation|Mean
16107|NCT01869686|Secondary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Serum|The area under the denosumab serum concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||days*ng/mL||Standard Deviation|Mean
16108|NCT01869686|Secondary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||days||Full Range|Median
16109|NCT01869686|Secondary|Maximum Observed Concentration (Cmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||ng/mL||Standard Deviation|Mean
16110|NCT01869686|Primary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Seminal Fluid|The area under the denosumab seminal fluid concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||days*ng/mL||Standard Deviation|Mean
16111|NCT01869686|Primary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data||days||Full Range|Median
16112|NCT01869686|Primary|Maximum Observed Concentration (Cmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population||ng/mL||Standard Deviation|Mean
16113|NCT01869647|Secondary|Prevalence of Urological Intervention|This measure presents the prevalence of participants needing urological intervention in each arm within 90 days.|90 days|||participants|||Number
16114|NCT01869647|Primary|Radiation Exposure (Dose-Length-Product) at Baseline|Radiation exposure at baseline was collected using the mean dose length product mGy*cm.|Baseline (at enrollment)|||mGy*cm||95% Confidence Interval|Mean
16115|NCT01869478|Secondary|Mean Score on Modified Rankin Scale at 90 Days|Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).|90 days|Only one participant was enrolled, so data analysis was not possible.|||||
16116|NCT01869478|Primary|Recanalization Rate of Primary Intracranial Occlusion|The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).|24 hours|Only one participant was enrolled, so data analysis was not possible.|||||
16117|NCT01869075|Primary|Percentage of Patients Prescribed Appropriate VTE Prophylaxis|"Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk.~Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control.~Appropriate VTE prophylaxis was defined as:~in Hip Fracture Surgery - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in Major General Surgery - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in Acute Medical Illness - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay.~Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study."|End of study (end of phase 2) - measured over duration of hospital stay.|The number of participants in the analysis was 720. In phase 1, there were 360 patients included and in phase 2, an additional 360 patients were included. The outcomes by end of study (end of phase 2) are reported. The patients in control (usual care) and intervention (Knowledge Translation toolkit) were compared.||percentage of patients|||Number
16118|NCT01868893|Secondary|Number of Participants With Objective Response|Objective response is defined as complete response [CR], complete response with incomplete recovery [CRi], or partial response as determined by the treating physician’s standard practice at the end of treatment or premature discontinuation from study.|Up to end of treatment or premature discontinuation from study|Efficacy evaluable population: It included participants who received at least one dose of study drug and had measurable disease at baseline and at least one post-baseline tumor assessment or who died within 28 days after the last dose of the study drug||participants|||Number
16119|NCT01868893|Secondary|Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 28 days after the last dose of study drug (End of Treatment)|Safety Population: It included all enrolled participants who received at least one dose of study drug.||participants|||Number
16120|NCT01868893|Primary|Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study|Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.|Cycles 1 to 6 (28-day cycles)|Intent-to-Treat population: It included all enrolled participants in the study.||participants|||Number
16140|NCT01868035|Secondary|Overall Survival|Overall survival (time to death) is defined from the start of treatment to the date of death from any cause.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||months||95% Confidence Interval|Median
16141|NCT01868035|Secondary|Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured.|Baseline; any follow-up visit (up to 72 months)|ITT Population||participants|||Number
20565|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
16121|NCT01868776|Primary|Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.|100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.|approximately 15 minutes after injection|||percentage of participants|||Number
16122|NCT01868776|Primary|Pain Measurement as Assessed on a Visual Analog Scale||pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection||12/2015||||
16123|NCT01868542|Secondary|Incidence of Adverse Events|A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20)|Week 20|"Safety analysis set - included all subjects receiving at least one dose of the trial product. Subjects in the safety set contributed to the evaluation as treated."||events|||Number
16124|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.||mg/dL||Standard Deviation|Mean
16125|NCT01868542|Secondary|Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms.|For 20 weeks of treatment and over 24 hours|Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”.||Number of episodes|||Number
16126|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|week 0, week 12|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.||mg/dL||Standard Deviation|Mean
16127|NCT01868542|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%|Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment.|Week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm ) arm.||percentage (%) of subjects|||Number
16128|NCT01868542|Secondary|Change in HbA1c|Change in HbA1c at 12 weeks of treatment from visit 2.|Week 0, week 12|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8)algorithm arm.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
16129|NCT01868542|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.|Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
16130|NCT01868503|Secondary|Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes|Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.|Up to 12 weeks||||||
16131|NCT01868503|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events will be tabulated by organ system and severity.|Up to 12 weeks||||||
16132|NCT01868503|Secondary|Change in the Proportion of BCSCs|Defined as the difference between the percentage of BCSCs before and after treatment. Proportion of biopsy samples that are evaluable for BCSCs will be estimated along with 95% exact confidence intervals. BCSC results will be summarized using medians and interquartile ranges. Changes in BCSCs will be assessed using the Wilcoxon signed rank test.|Baseline to 12 weeks||||||
16133|NCT01868503|Secondary|Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP|Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.|12 weeks||||||
16134|NCT01868503|Primary|Percentage of Patients Achieving Complete Clinical Response|Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).|Up to 12 weeks|||Participants|||Count of Participants
16135|NCT01868243|Secondary|Spontaneous Echo Contrast|Spontaneous Echo Contrast showed in Transesophageal echocardiography|90 days|||participants|||Number
16136|NCT01868243|Primary|Intracardiac Thrombus|The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).|90 days|A total of 34 patients were selected between August 2013 and November 2014 (6 were excluded for previous intracardiac thrombus; 1 for unstable INR control). Of the 27 randomized, 15 were assigned to receive dabigatran and 12 to receive warfarin.||participants||95% Confidence Interval|Number
16137|NCT01868074|Secondary|Change in CPEI (3mph)|The Center of Pressure Excursion Index (CPEI) is a measurement of the lateral displacement of the center of pressure curve from a reference line drawn from the initial to the final centers of pressure during stance phase of gait, and standardized to the width of the anterior third of the foot during pedobarography.|baseline, 8 weeks postpartum|||ratio||Standard Error|Mean
16138|NCT01868074|Secondary|Change in Arch Rigidity|The arch rigidity index, a measure of the ability of the foot to maintain the arch when weight-bearing, was determined by dividing the standing AHI by the seated AHI. A value of 1.0 would indicate a perfectly rigid arch, while smaller values would indicate a more flexible arch.|baseline, 8 weeks postpartum|||ratio||Standard Error|Mean
16142|NCT01868035|Secondary|Number of Participants Needing Supportive Care at Week 7 and Week 13|During the administration of unlabeled Anti-B1 antibody and Iodine-131 Anti-B1 antibody, emergency support for anaphylaxis, including epinephrine, diphenhydramine, hydrocortisone, a laryngoscope, and an endotracheal tube, was readily available. The use of steroids were discouraged unless other measures were ineffective.|Week 7 and Week 13|ITT Population||participants|||Number
16143|NCT01868035|Secondary|Time to Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Nadir is defined as the lowest counts (for ANC, WBC, and platelet counts)/concentration (for hemoglobin) that the cells reach after chemotherapy. Time to nadir is defined as the time from Baseline to the lowest value recorded up to 120 days following the therapeutic dose.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||days||Standard Deviation|Mean
16144|NCT01868035|Secondary|Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), hemoglobin, platelet count, WBC count. Nadir is defined as lowest counts that the cells reach after chemotherapy.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||10^3 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
16145|NCT01868035|Secondary|Time to Recovery From the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Time to recovery to Baseline grade for participants with Grade 0 toxicity at Baseline was defined as the time from the date of the last administration of study drug to the first post-nadir date with Grade 0 toxicity, with no other Grade 1-4 toxicities recorded during the next week. For participants with a Grade 1-4 toxicity at Baseline, time to recovery was defined as the time from the last administration of study drug to the first post-nadir date with a Baseline grade or better, with no other higher grade toxicities recorded during the next week. For participants with a nadir grade less than or equal to the Baseline grade, the time to recovery to the Baseline grade equaled the time to nadir.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||days||95% Confidence Interval|Median
16146|NCT01868035|Secondary|Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a casual relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or significant worsening of a pre-existing sign or symptom, or disease temporally associated with the use of a medicinal product. An SAE is defined as any experience occurring at any dose that results in the following outcomes: death, a life-threatening adverse experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. See the SAE/AE module for a complete list of SAEs/AEs.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||participants|||Number
16147|NCT01868035|Secondary|Total Body Residence Time (TBRT)|TBRT is the time at which the activity of infusion is 37% of that at time zero. Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. The assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the TBRTs. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||hours||Standard Deviation|Mean
16148|NCT01868035|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the start of treatment to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||months||95% Confidence Interval|Median
16149|NCT01868035|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the start of treatment to the first documented progression or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population||months||95% Confidence Interval|Median
16150|NCT01868035|Secondary|Duration of Response and Duration of Confirmed Complete Response|Duration of response for all participants with confirmed PR, confirmed CRu, or confirmed CR is defined as the time from the first documented response to the first documented progression. CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and the normalization of biochemical abnormalities definitely assignable to NHL. PR is defined as a >=50% decrease in the sum of the perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. Only those participants with a confirmed response were analyzed. Duration measures were calculated using Kaplan-Meier techniques.||months||95% Confidence Interval|Median
16165|NCT01867658|Primary|Rate of Device and/or Procedure-related Adverse Events|The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.|One (1) month follow-up|Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation.||percentage of participants||90% Confidence Interval|Number
16151|NCT01868035|Secondary|Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)|CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to non Hodgkin's lymphoma (NHL). PR is defined as a >=50% decrease in the sum of perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. SD is defined as less than a PR, but not PD, which is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. RD is defined as the appearance of any new lesion or an increase of >= 50% in the size of nodules. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. A con. CR+CRu requires that the best response be con. by the same response or better >=4 weeks apart. The individual rows for con. CR, CRu, and PR represent par. with the best response con. by the same exact response. One par. in the CR+CRu category is not counted in the con. CR category because the CR was not con. by another CR.||participants|||Number
16152|NCT01868035|Primary|Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody|Hematology parameter grades were summarized according to the National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) <1000 cells/millimeters cubed (mm^3), white blood cells (WBC) <2000 cells/mm^3, platelets <50000 cells/mm^3, and hemoglobin < 8.0 grams/deciliter.|From Baseline until Week 25 and follow-up (up to 130 months)|Intent-to-treat (ITT) Population: all participants who received study drug||participants|||Number
16153|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Size of the Device|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence.|up to Study Day 26|PP Population. Only those participants responding to the question regarding the specified attribute were analyzed.||Participants|||Number
16154|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence.|up to Study Day 26|PP Population||Participants|||Number
16155|NCT01868009|Primary|Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.|up to Study Day 26|Per Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (comprised of all participants who had been randomized and received one dose of at least one study inhaler) who completed at least one question from the seven preference questions||participants|||Number
16156|NCT01867710|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12|The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline.|Week 12|Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants||95% Confidence Interval|Number
16157|NCT01867710|Primary|Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment|No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.|Week 24|Safety population included all randomized and treated participants. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of Participants||95% Confidence Interval|Number
16158|NCT01867658|Secondary|Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up|The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.|Baseline and One (1) Month Follow-up|MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure.||units on a scale||Standard Deviation|Mean
16159|NCT01867658|Secondary|Duration of Hospitalization (Length of Stay)||Days 0-20|MITT Population minus 2 subjects who died prior to discharge||Days||Standard Deviation|Mean
16160|NCT01867658|Secondary|Duration of Chest Tube Drainage||Day 0-46|MITT Population minus 1 subject with missing data||Days||Standard Deviation|Mean
16161|NCT01867658|Secondary|Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals||Day 0-46|MITT population minus 1 subject with missing data.||Days||Standard Deviation|Mean
16162|NCT01867658|Secondary|Percent of Subjects Who Are Free From Air Leaks Immediately Following Surgery||Day 0|||percentage of participants|Participants|95% Confidence Interval|Number
16163|NCT01867658|Secondary|Percentage of Air Leaks That Are Sealed or Reduced||Day 0|Subjects in the mITT population||percentage of air leaks|Participants|95% Confidence Interval|Number
16164|NCT01867658|Secondary|Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up||One (1) month|MITT Population||percentage of participants||90% Confidence Interval|Number
16176|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Concentration||Baseline, Week 8|||umol/L||95% Confidence Interval|Least Squares Mean
16166|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Physician|Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
16167|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Participant|Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
16168|NCT01867164|Primary|Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment|Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' signifies participants who were evaluated for this outcome measure including the participants for whom no culture was performed.||Percentage of Participants|||Number
16169|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
16170|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure.||Percentage of Participants|||Number
16171|NCT01867021|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.|Day 1 to 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
16172|NCT01867021|Secondary|Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).|Day 22|Analysis was done on the PPS1||Ratios||95% Confidence Interval|Geometric Mean
16173|NCT01867021|Secondary|Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|"Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22).~Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine.~According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (<65 years) or ≥30% (≥65 years).~As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (<65 years) or ≥60% (≥65 years)."|Day 22|Analysis was done on the PPS1 for HI Titer ≥1:40 at day 22 and PPS2 for Seroconversion||Percentages of subjects||95% Confidence Interval|Number
16174|NCT01867021|Primary|Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years|"Non-Inferiority was measured as the percentages of subjects who achieved seroconversion in HI titers three weeks (day 22) after vaccination of TIV compared with TIVf, against each of three vaccine strains.~Seroconversion is defined as a prevaccination titer <10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer.~The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%."|Day 22|Analysis was done on the PPS2, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at visit 1 and visit 2; and had no major protocol violations as defined prior to analysis||percentages of subjects||95% Confidence Interval|Number
16175|NCT01867021|Primary|Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years|"Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV (Trivalent Subunit Inactivated Influenza Vaccine) Group Over the Corresponding TIVf Group for All Three Strains, three weeks after vaccination (day 22).~The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5."|Day 22|Analysis was done on the per-protocol set 1 (PPS1) , ie, the subjects who received the vaccine correctly; provided evaluable serum samples at visit 2; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
16180|NCT01866709|Primary|Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events.|To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline.|First 48 hours|Study prematurely terminated for safety reasons; no statistical analyses were conducted.|||||
16181|NCT01866319|Secondary|Overall Response Rate (ORR)|"ORR was defined as the percentage of the participants with a best tumor response of complete response (CR) or partial response (PR) based on blinded independent central radiologic and clinical review using RECIST 1.1. CR was defined as disappearance of all target lesions with any pathological lymph nodes having a reduction in short axis to <10 mm. PR was defined as a 30% or greater decrease in the sum of diameters of target lesions.~Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants randomized to a study arm; data collected through 3 September 2014.||Percentage of Participants||95% Confidence Interval|Number
16182|NCT01866319|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. The reported percentage is estimated using a product-limit (Kaplan-Meier) method for censored data; for participants whose survival data was obtained after the data cut-off date for the interim analysis, data were censored at the date of cut-off (3 March 2015). Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).|Month 12|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 March 2015.||Percentage of participants||95% Confidence Interval|Number
16183|NCT01866319|Primary|Progression-free Survival (PFS)|"PFS was defined as the time from randomization to the first documented disease progression, based on blinded independent central radiologic and clinical review using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5mm or the appearance of new lesions.~Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 September 2014.||Months||95% Confidence Interval|Median
16184|NCT01866163|Secondary|m-PASI at Week 1|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).~m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.~The m-PASI score range from 0 (best) to 64.8 (worst)."|1 week|All randomised subjects were included in the full analysis set and analysed for efficacy.||Scores on a scale||95% Confidence Interval|Mean
16185|NCT01866163|Secondary|m-PASI at Week 4|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).~m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.~The m-PASI score range from 0 (best) to 64.8 (worst)."|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.||Scores on a scale||95% Confidence Interval|Mean
16186|NCT01866163|Primary|Treatment Success According to IGA|"Subjects with ‘treatment success’ (‘clear’ or ‘almost clear’ for subjects with at least moderate disease at baseline, ‘clear’ for subjects with mild disease at baseline) according to the Investigators’ global assessment of disease severity (IGA) at Week 4.~The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe"|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.||percentage of subjects|||Number
16187|NCT01866150|Secondary|Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment|The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.||swollen joints||Standard Deviation|Mean
16188|NCT01866150|Secondary|Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.||tender joints||Standard Deviation|Mean
16189|NCT01866150|Secondary|Average Methotrexate Dose of Participants on Biological Combination Treatment||Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Participants in biologic combination group from All Participants Entered Analysis Set. Number of participants analyzed=participants with available data for methotrexate dose.||milligrams per week||Standard Deviation|Mean
16199|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 6 weeks after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
16190|NCT01866150|Secondary|Duration of Treatment|Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.|Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data for duration of treatment.||months||Standard Deviation|Mean
16191|NCT01866150|Secondary|Percentage of Participants by Category of DAS28 Score and Timepoint|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for the endpoint. Here, 'n' signifies number of participants with available data for specifies category.||percentage of participants|||Number
16192|NCT01866150|Secondary|Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.||units on a scale||Standard Error|Mean
16193|NCT01866150|Secondary|Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6. LDA was defined as a DAS28 score <3.2.|Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
16194|NCT01866150|Secondary|Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 * √ of TJC) + (0.28 * √ of SJC) + (0.70 * ln ESR in mm/h) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score < 2.6.|Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
16195|NCT01866150|Primary|Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.|Month 6|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR at Month 6.||percentage of participants|||Number
16196|NCT01864434|Primary|Kinematics - Ramp Down Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity|3 months post-operative|||mm||Standard Deviation|Mean
16197|NCT01864434|Primary|Kinematics - Ramp up Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity|3 months post-operative|||mm||Standard Deviation|Mean
16198|NCT01864434|Primary|Kinematics - Deep Knee Bend Activity|Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity|3 months post-operative|||mm||Standard Deviation|Mean
16200|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 24 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
16201|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 8 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
16202|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 0.5 hour after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
16203|NCT01864005|Primary|the Percentage Inhibition of the P2Y12 Receptor|Note: the primary endpoint was changed per the statistical analysis plan prior database lock.|at 2 hours after first dose of study drug|FAS (full analysis set). Three randomized patients were excluded from FAS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.||Percentage Inhibition||Standard Deviation|Mean
16204|NCT01863953|Secondary|Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.|Day 14, Day 28, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment||mmHg||Standard Deviation|Mean
16205|NCT01863953|Secondary|Change From Baseline in Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14, Day 28|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment||mmHg||Standard Deviation|Mean
16206|NCT01863953|Primary|Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
16207|NCT01863771|Secondary|Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54|Mucosal healing is defined as an endoscopy subscore of 0 or 1, where 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern, mild friability). Endoscopy subscore is one of the 4 subscores of the Mayo score.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.||participants|||Number
16208|NCT01863771|Secondary|Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54|Clinical remission (as measured by the Mayo score) was defined as a Mayo score of less than or equal to (<=) 2 points, with no individual sub-score greater than (>) 1.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.||participants|||Number
16209|NCT01863771|Primary|Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score|Clinical response was defined as a decrease from Induction-Week 0 in the Mayo score by greater than or equal to (>=) 30 percent and >=3 points, with a decrease in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.|Up to Week 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.||participants|||Number
16210|NCT01863680|Secondary|Serum Progesterone Level|Two pharmacokinetic (PK) samples were collected per subject for the measurement of serum progesterone concentrations; 1st sample at Visit 2-2 (prior to hCG administration) and second sample during Visit 5 (Day 14+/-3, 7 hours after the morning of investigational medicinal product administration).|Visit 2-2 (Prior to hCG administration) and Visit 5 (Day 14+/-3)|"The PK analysis set included all subjects who had serum beta-hCG pregnancy test performed at Visit 5 (Day 14+/-3), who had two progesterone concentrations at Visit 2-2 and Visit 5, and who had no relevant problems for compliance of administration until Visit 5. n signifies the number of subjects who were evaluable in each category, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
16247|NCT01861522|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||Randomization, Week1 and Week 2||||||
16248|NCT01861522|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||baseline, Week1 and Week 2||||||
16211|NCT01863680|Secondary|Biochemical Pregnancy Rate Per Embryo Transfer|Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS during Visit 6 (Week 5), but with a positive serum beta-hCG pregnancy test result at Visit 5 (Day 14+/-3). Biochemical pregnancy rate was calculated as the number of subjects who had no fetal sac observed during Visit 6 (Week 5) TVUS assessment or subjects who had a positive serum pregnancy test at Visit 5 (Day 14+/-3) and no data recorded at Visit 6 (Week 5) divided by the number of subjects who has at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.||Percentage of pregnancy/embryo transfer|||Number
16212|NCT01863680|Primary|Clinical Pregnancy Rate Per Embryo Transfer|Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.||Percentage of pregnancy/embryo transfer|||Number
16213|NCT01863667|Secondary|Change From Baseline in Body Weight at Week 54|Body weight was to be measured (in duplicate) using a calibrated digital scale.|Baseline and Week 54|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54.|||||
16214|NCT01863667|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia|An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.|||||
16215|NCT01863667|Secondary|Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment|Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
16216|NCT01863667|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment|Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
16217|NCT01863667|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54|This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
16218|NCT01863667|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.||Percentage of participants|||Number
16219|NCT01863667|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 57 weeks (including 3 weeks following the last dose of study drug)|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.||Percentage of participants|||Number
16220|NCT01863667|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 54|A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.|||||
16221|NCT01863433|Secondary|Type and Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
16222|NCT01863433|Secondary|Type and Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
16223|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
16224|NCT01863433|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||fold increase||Standard Deviation|Geometric Mean
16225|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
16226|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.||units on a scale||Standard Deviation|Mean
16227|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.||units on a scale||Standard Deviation|Mean
16228|NCT01863368|Secondary|Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)|The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.||units on a scale||Standard Deviation|Mean
16229|NCT01863368|Primary|Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)|The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.|Baseline, Day 35|This analysis group includes all randomized subjects with data at visit.||units on a scale||Standard Deviation|Mean
16230|NCT01863134|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE)|MACCE was defined as combined death, nonfatal myocardial infarction, cerebrovascular event (stroke) and the need for re-hospitalization due to recurrent ischemia up to 12 months follow-up|Up to 12 month|||Percentage of study group|||Number
16231|NCT01862484|Primary|ADHD Rating Scale IV|The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998.|5 weeks|Children with ADHD who completed the five week diet and parents filled out the ADHD rating scale.||units on a scale||Standard Deviation|Mean
16232|NCT01862419|Primary|Relative Maximum Change in Creatinine||7 days of randomization|||relative percent change||Inter-Quartile Range|Median
16233|NCT01862419|Primary|Death||7 days of randomization|||participants|||Number
16234|NCT01862419|Primary|Dialysis Within 7 Days|This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis.|From start of AKI to 7 days later|||participants|||Number
16235|NCT01862133|Primary|Providers' Opinion of Patients' Controlling EHR Access|"Percent of providers answering Strongly Agree or Agree to the following question on the post-study survey: I think it is OK for patients to have control over who sees what information in their electronic health records."|6 month study||03/2015||||
16236|NCT01862133|Primary|Number of Patients Recording Preferences to Restrict Provider Access to Some or All EHR Data|"Patients had to restrict access to either all data or one of five categories of sensitive data (sexually transmitted infections, HIV/AIDS, sexual health and pregnancy, drug and alcohol use and abuse, and mental health information) to one or more of the study providers."|6 month study|All patients recorded their preferences and completed the questionnaire. 24 (77%) of the 31 providers completed the anonymous post-study questionnaire.||participants|||Number
16249|NCT01861522|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week1 and Week 2||||||
16250|NCT01861522|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||baseline, Week1 and Week 2||||||
16405|NCT01856686|Secondary|Impulsivity Score|Impulsivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months|||units on a scale||Standard Deviation|Mean
16237|NCT01861925|Post-Hoc|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Normalized Differences of Keratometry Axis Measurement Between Both Devices.|"For definition of keratometry axis see outcome measures 4 and 5.~This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of normalized difference and 95% confidence interval of mean normalized difference for axis of flat meridian.~Difference is normalized for each eye as function of astigmatism to a refractive error of 0.167 diopters (i.e. an axis difference of 1 normalized degree results in a refractive error of 0.167 diopter), to provide a measure which can be directly related to its impact on visual quality.~Please note that for this analysis a separation in arms normal eye and large regular astigmatism is not meaningful, thus here both groups are analyzed jointly as group regular eye"|1 day of examination|||normalized degree||95% Confidence Interval|Mean
16238|NCT01861925|Other Pre-specified|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Axis Measurement Between Both Devices.|"Keratometry axis refers to the axis of the flat meridian of the toric representation of the cornea. For additional information see outcome 4.~This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of difference and 95% confidence interval of mean difference for axis of flat meridian."|1 day of examination|||degree||95% Confidence Interval|Mean
16239|NCT01861925|Other Pre-specified|Equivalence of Keratometry Radius Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Radius Measurement Between Both Devices.|"Keratometry radius refers to the corneal curvature R (see primary measure outcome). In this context, the cornea is approximated by a toric surface which can be characterized by a flat meridian (radius R1) and a steep meridian (radius R2) with an angle of 90 degrees between these meridians.~This outcome measure aims at testing the equivalence of keratometry radius measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of difference and 95% confidence interval of mean difference for radius of flat meridian (R1) and radius of steep meridian (R2)."|1 day of examination|||micrometer||95% Confidence Interval|Mean
16240|NCT01861925|Other Pre-specified|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Std. Dev. of Local Corneal Elevation Differences for One Measurement Per Device.|"For definition of corneal topography, areas of evaluation and methods, see outcome 1 and 2.~Corneal elevation refers to the distance between the measured corneal surface and the best fitting sphere, and is given in µm.~This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.~elevation difference (2 std. dev.) is the sample mean of twice the standard deviation of local corneal elevation differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination|||micrometer||95% Confidence Interval|Mean
16241|NCT01861925|Secondary|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device.|"For definition of corneal topography, corneal power in diopter, areas of evaluation and methods, see outcome 1.~This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.~power difference (2 devices) is the sample mean and 95% C.I. of differences of spatial mean of corneal power between two devices. This value quantifies systematic differences between devices (e.g. calibration), ignoring local variations of the power measurement.~power difference (2 std.dev.) is the sample mean of twice the standard deviation of local power differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination|||diopters||95% Confidence Interval|Mean
16242|NCT01861925|Primary|In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements|"Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. Diopter is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R.~Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination.~According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm<d<=6mm.~power difference (2 rep. meas.): sample mean and 95% C.I. of differences of spatial mean of corneal power between two consecutive measurements.~power difference 2 std.dev.: sample mean of twice the deviation of local power differences (two consecutive measurements)."|1 day of examination|||diopters||95% Confidence Interval|Mean
16243|NCT01861704|Secondary|Gain, Speech Understanding and Sound Quality||During useful lifespan of device||||||
16244|NCT01861704|Secondary|Device Comfort||During useful lifespan of device||||||
16245|NCT01861704|Primary|Immediate Refit Upon Device Removal|Upon device removal, a qualified audiologist examined subjects’ ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.|Following device removal at the same appointment (Up to 24 hours after removal)|Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument||percentage of ears|Participants|90% Confidence Interval|Number
16246|NCT01861522|Secondary|Adverse Events and Adverse Drug Reactions||Week 2||||||
16251|NCT01861522|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).|Baseline and Week 2|||units on a scale||Standard Error|Least Squares Mean
16252|NCT01861457|Secondary|Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10 hour workday|||Percent change in colonization||Inter-Quartile Range|Median
16253|NCT01861457|Primary|Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10-hour work day|All participants who received 3 scheduled treatments||Percent change in colonization||Inter-Quartile Range|Median
16254|NCT01861301|Other Pre-specified|Association Between Baseline HGF, MET Gene Amplification, MET IHC and PFS|Will be evaluated using the Cox regression model.|Baseline to 1 year||||||
16255|NCT01861301|Other Pre-specified|Change in Serum HGF or MET IHC and Tumor Size Change (Percent Reduction in Sum of Longest Diameters)|Will be evaluated by Spearman’s rank correlation coefficient.|Baseline to 1 year||||||
16256|NCT01861301|Other Pre-specified|Change in Baseline Levels of Continuous or Ordinal Markers (e.g., Serum HGF/MET IHC) Between Responders and Non-responders|Fisher’s exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar’s test will be used for binary markers.|Baseline to 1 year||||||
16257|NCT01861301|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Analyzed using the Kaplan-Meier method.|Up to 2 years|||Months||95% Confidence Interval|Median
16258|NCT01861301|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method.|Up to 2 years|||Months||95% Confidence Interval|Median
16259|NCT01861301|Secondary|Incidence of Adverse Events, Graded Per NCI CTCAE Version 4|Grade 3 or higher AE of any type, regardless of attribution.|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
16260|NCT01861301|Primary|Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year|Note: Study terminated for futility due to insufficient number of objective responders in first stage.||percentage of participants||95% Confidence Interval|Number
16261|NCT01860989|Primary|28-day Cure Rate|28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).|Day 28|PharmacoDynamic (PD) Analysis Set - All the 11 patients were included in PD analysis set.||Percentage of participants|||Number
16262|NCT01860703|Secondary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||milliseconds||Standard Deviation|Least Squares Mean
16263|NCT01860703|Primary|Maximum Change From Baseline (dQT/dQTc)|"Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||percentage of participants|||Number
16264|NCT01860703|Primary|Maximum Postdose QT/QTc Interval|"The maximum post-dose QT/QTc interval for deferiprone and placebo.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||percentage of participants|||Number
16265|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||milliseconds||Standard Deviation|Least Squares Mean
16266|NCT01860703|Secondary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||hour||Standard Deviation|Mean
16280|NCT01860079|Primary|All Cause Mortality and Readmission at 30 Days.|The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.|30 DAYS|||participants|||Number
16267|NCT01860703|Secondary|AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide|"AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||μg *hr/mL||Standard Deviation|Mean
16268|NCT01860703|Secondary|Tmax of Deferiprone and Deferiprone 3-O-glucuronide|"To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||hour||Full Range|Median
16269|NCT01860703|Secondary|Cmax of Deferiprone and Deferiprone 3-O Glucuronide|"To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.||μg/mL||Standard Deviation|Mean
16270|NCT01860703|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone|From administration of the first dose until 7 days +/- 1 day following the final dose|The Safety Analysis Set consisted of all subjects who received at least 1 dose of study medication and had at least 1 safety assessment.||participants|||Number
16271|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).||milliseconds||Standard Deviation|Least Squares Mean
16272|NCT01860534|Secondary|Pain|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores > to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||units on a scale||Standard Deviation|Mean
16273|NCT01860534|Secondary|Oxygen Percent Saturation|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||percent saturation||Standard Deviation|Mean
16274|NCT01860534|Secondary|Respiratory Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||Breaths per minutes||Standard Deviation|Mean
16275|NCT01860534|Primary|Heart Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops|||Beats per minutes||Standard Deviation|Mean
16276|NCT01860521|Secondary|Total Sufentanil Consumption.||During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).|||microg||Standard Deviation|Mean
16277|NCT01860521|Secondary|Total Levobupivacaine Consumption||At the moment of fetal expulsion (up to 66 hours from starting of the procedure).|||mg||Standard Deviation|Mean
16278|NCT01860521|Secondary|Degree of Satisfaction of the Patients With the Analgesia Procedure|At discharge from the hospital, patients were requested to answer the following question “Taking into consideration the variations in pain symptoms, as well as the adverse events experienced, if any, how would you define the grade of satisfaction with your analgesic treatment?” The grade of satisfaction was assessed using a visual analog scale (VAS) where 0 corresponded to “completely unsatisfied” and 100 to “completely satisfied”.|At discharge from the hospital (up to 72 hours from starting of the procedure).|||mm||Standard Deviation|Mean
16279|NCT01860521|Primary|Incidence of Motor Block|The assessment of the degree of motor block was performed in the right and left lower extremities using the Breen modified Bromage score: 1 = complete block (unable to move feet or knees), 2 = almost complete block (able to move feet only), 3 = partial block (just able to move knees), 4 = detectable weakness of hip flexion while supine (between scores 3 and 5), 5 = no detectable weakness of hip flexion while supine (full flexion of knees), and 6 = able to stand and to perform partial knee bend. Patients with a Bromage score < 6 were considered to have motor block.|Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).|||participants|||Number
16281|NCT01859949|Secondary|Height SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.~Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
16282|NCT01859949|Secondary|Height Velocity SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.~Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
16283|NCT01859949|Secondary|Height SDS for Chronological Age|"Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values on the participant age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
16284|NCT01859949|Secondary|Height Velocity|Height velocity is the yearly height gain|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||cm/year||Standard Deviation|Mean
16285|NCT01859949|Secondary|Height Velocity Standard Deviation Score (SDS) for Chronological Age|"Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values of the participants age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||SDS||Standard Deviation|Mean
16286|NCT01859949|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.||participant|||Number
16287|NCT01859793|Secondary|Circulating Inflammatory Markers VCAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subject who completed the study. Once subject had missing data for the post-8 weeks of each intervention||mg/mL||Standard Deviation|Mean
16288|NCT01859793|Secondary|Circulating Inflammatory Marker ICAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subjects who completed both arms of the study. One subject was missing the measurements post 8 weeks of each intervention arm and was excluded||mg/mL||Standard Deviation|Mean
16289|NCT01859793|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans|Change before and after a single dose (2 hours post) and 8 weeks after daily dosing|All 30 subjects who completed both arms of the cross-over study||%FMD||Standard Deviation|Mean
16290|NCT01859715|Secondary|Adverse Drug Events|Determine all possible adverse drug events that occurred after the study drugs were administered.|Duration of ED stay, <24 hours. (up to 24 hours)|||participants|||Number
16291|NCT01859715|Primary|Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users|Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.|Baseline and 90 minutes|||millimeters||95% Confidence Interval|Mean
16292|NCT01859702|Primary|Mean Aqueous Humor Concentration of Moxifloxacin|A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.|Day 3 (operative day)|Per protocol: All subjects who met inclusion/exclusion criteria, received all doses of the test product, and underwent cataract surgery with aqueous humor sampling.||nanograms per milliliter||95% Confidence Interval|Mean
16293|NCT01859637|Secondary|Change in Absolute Neutrophile Count (ANC)|"To evaluate the efficacy of Zarzio®/Filgrastim HEXAL® in patients with SCN in terms of changes in absolute neutrophile count (ANC).~Change from each visit to baseline in ANC for all patients is calculated."|Participants were followed for a duration of 12 months and ANC was assessed at baseline, week 6, Month 3, Month 6, Month 9 and Month 12.|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment||10^9 cells/L||Full Range|Median
16294|NCT01859637|Secondary|Number of Participants With Adverse Events (AEs)|Patients experiencing AEs by system organ class and preferred term (PT) and number of events. Patients with more than one AE coded to the same PT were counted once per PT|12 months|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment||participants|||Number
16338|NCT01857882|Secondary|Uptake Rate of Breast Reconstruction-Service Outcome|The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)|Six months after initial consultation||||||
16406|NCT01856686|Secondary|Hyperactivity Score|Hyperactivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months|||units on a scale||Standard Deviation|Mean
16295|NCT01859637|Primary|Incidence of Anti- Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) Antibodies|"Incidence of anti-rhG-CSF antibodies was monitored. Patients were screened for anti-rhG-CSF antibodies at screening and at each study except visit 02 (start of treatment = baseline).~Evaluation of immune response to rhG-CSF administration was made by a three-step procedure comprising a validated binding antibody screening and confirmatory radioimmunoprecipitation assay (RIP) and a validated cell-based neutralization antibody assay (NAB)."|screening, 3, 6, 9 and 12 months|Safety population (SAF): All patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment. All six patients were screened for anti-rhG-CSF antibodies at all six study visits, except for one missing assessment (no sample was taken for patient 0204 at Visit 03, which was an optional visit).||participants|||Number
16296|NCT01859611|Secondary|Adverse Events.|At every treatment and follow-up visit the treated areas will be examined to evaluate side effects and adverse reactions remaining from the previous treatment session or occurring since then.|Subjects will be followed for the duration of the study, and expected average of 20 weeks||||||
16297|NCT01859611|Secondary|Patient Satisfaction and Comfort of the Treatment.|At each of the specified time points, subjects will complete a Subject Evaluation Form assessing their opinion of improvement and overall satisfaction with treatment.|Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU||||||
16298|NCT01859611|Primary|Changes to the Surface by Visual and Photographic Analysis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri-orbital wrinkles.~Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale.~Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe"|3 Month FU|Number of participants with observed changes (grade of improvement ≥ 1) to the surface of the skin based on photographic analysis at 3 Month FU||participants|||Number
16299|NCT01859598|Secondary|Overall Weight Gain From Visit 1 to Visit 3|the weight gain= the mean weight at visit1 - the mean weight at visit 3|baseline and 6 months|Patients at visit 3 were used for analyzing the change of weight||Kg||Standard Deviation|Mean
16300|NCT01859598|Secondary|the FPG Control Rate at Visit 3|the percentage of patients who had the FPG level <7.0 mmol/L at visit 3|6 months|At visit 3, the patients who self-reported their FPG level were used for analysis||percentage of patients with FPG<7.0|||Number
16301|NCT01859598|Secondary|the FPG Change From Visit 1 to Visit 3|the FPG change = the FPG level at visit 1- the FPG level at visit 3|baseline and 6 months|the population in the visit 3 were used for analysis||mmol/L||Standard Deviation|Mean
16302|NCT01859598|Primary|the Change of Hypoglycemia During Follow-up.|•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)|baseline and 6 months|The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3||percentage of patients with hypoglycemia|||Number
16303|NCT01859598|Primary|To Assess the Change in HbA1c During the 6 Months Follow-up.|• Change of HbA1c from baseline to the end-point (6 month).|Baseline and 6 months|the patients who have the results of HbA1c||percent||Standard Deviation|Mean
16304|NCT01859507|Secondary|Successful Sexual Relationship|The level of comfort by the couple. The secondary outcome will be assessed by the couple. The couple is allowed to visit for follow up every three months for twelve months. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completedwithout premature interruption from either partners.|Within twelve months after the Botox injection|||participants|||Number
16305|NCT01859507|Primary|Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain|The primary outcome will be assessed by the couple. The couple is allowed to visit for follow up in a 4 weeks' time. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completed without premature interruption from either partners.|Up to four weeks following the last session of the vaginal dilatation.|multiple penetration with minimal pain as informed by the couple during their follow up sessions 4 weeks after the completion of the dilatation sessions||participants|||Number
16306|NCT01859494|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event).||Participant Responses|||Number
16307|NCT01859494|Secondary|Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject.||Blood Glucose results within 15mg/dL/20%|||Number
16308|NCT01859494|Secondary|Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing.||Blood Glucose results within 15mg/dL/20%|||Number
16309|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) or +/- 12.5% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.||Bld Glucose results w/in 12.5mg/dL/12.5%|||Number
16310|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.||Blood Glucose results within 15mg/dL/15%|||Number
16311|NCT01859494|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject.||Blood Glucose results within 15mg/dL/20%|||Number
16312|NCT01859247|Secondary|Composite Measure of Patient Rating of Symptoms and Tolerability|"This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being completely tolerable and 10 completely intolerable."|Assessment completed immediately after rTMS treatment session|||units on a scale||Standard Deviation|Mean
16313|NCT01859247|Secondary|Dorsal Premotor-motor Inhibition (dPMI)||Change from baseline dPMI to post-intervention within 1 hour of treatment|two subjects did not have dPMI measured||percentage||Standard Deviation|Mean
16314|NCT01859247|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).|Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment|||units on a scale||Standard Deviation|Mean
16315|NCT01859143|Secondary|Percentage of Participants Who Required Antipyretic and/or Analgesic Medication||Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||percentage of participants|||Number
16316|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 180 days after the dose that were absent before treatment or that worsen relative to pretreatment state. An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Results are given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.|Within 28 and 180 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||participants|||Number
16317|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 14 days after vaccination that were absent before treatment or that worsened relative to pre-treatment state. Results are given for AEs reported within 7 days and 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||participants|||Number
16318|NCT01859143|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms included fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results are reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||percentage of participants|||Number
16319|NCT01859143|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Within 7 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.||percentage of participants|||Number
16320|NCT01858766|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
16321|NCT01858766|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
16322|NCT01858766|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
16323|NCT01858766|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
16324|NCT01858701|Primary|Mean Ocular Coma Score at 5mm Pupil at Day 30|Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.|Day 30|This analysis population includes all participants who completed the study.||micrometers||Standard Deviation|Mean
16325|NCT01858636|Primary|The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.||within 5 minutes of device deployment|||% of proc. w/hemostasis within 5 min|Participants|95% Confidence Interval|Number
16326|NCT01858636|Primary|The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication|"Major vascular complications include:~Access Site Complications:~Hematoma >10 cm in size requiring surgical or percutaneous intervention~Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention~Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention~Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics~A/V Fistula requiring medical intervention (percutaneous or surgical)~Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)"|30 days post procedure|All subjects with device deployments.||% of subjects with MVCs||95% Confidence Interval|Number
16327|NCT01858376|Secondary|Changes From Baseline in Platelet Aggregometry|Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|||maximum % aggregation||95% Confidence Interval|Mean
16328|NCT01858376|Secondary|C-reactive Protein|C-reactive protein in blood as measured in a standard hospital laboratory. Looking at Baseline to 12 weeks on supplement with a two week washout period|up to one year||||||
16329|NCT01858376|Secondary|Changes in High-Sensitivity C-reactive Protein|High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|||mg/dl||95% Confidence Interval|Mean
16330|NCT01858376|Primary|Change From Baseline in Lipid Profile|Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|number of participants analyzed is different from the participant flow module due to subjects who self reported non-compliance from pill count of the supplements and their data was not able to be used for this outcome measure.||mg/dl||95% Confidence Interval|Mean
16331|NCT01857882|Other Pre-specified|Completion of Primary Outcome Measure-feasibility Outcome|Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.|1 week after initial consultation||||||
16332|NCT01857882|Other Pre-specified|Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome|The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered.|Duration of treatment-8 hours on day of treatment||||||
16333|NCT01857882|Other Pre-specified|Recruitment Rate-feasibility Outcome|As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.|Duration of recruiting, expected on average two months||||||
16334|NCT01857882|Secondary|Medical Outcomes Study Social Support Survey|Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support.|baseline||||||
16335|NCT01857882|Secondary|Breast Reconstruction Knowledge Test|This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.|Change in baseline breast reconstruction knowledge at 1 week after initial consultation||||||
16336|NCT01857882|Secondary|Number of Consultations-service Outcomes|The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.|Six months after initial consultation||||||
16337|NCT01857882|Secondary|Length of Consultation-service Outcome|The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.|Duration of initial consultation||||||
16339|NCT01857882|Secondary|Qualitative Interview Assessment|A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.|Within three months after initial consultation||||||
16340|NCT01857882|Secondary|Satisfaction With Information (Sub-scale of BREAST-Q)|"The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The Satisfaction with Information Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction."|T1 (1 week after surgical consultation)||||||
16341|NCT01857882|Secondary|Patient Involvement in Care Scale (PICS)|PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.|T1 (1 week after surgical consultation)||||||
16342|NCT01857882|Secondary|Decision Preference and Decision Choice|Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention.|baseline||||||
16343|NCT01857882|Secondary|Decision Conflict Scale|Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).|Change from baseline decision conflict at 1 week after surgical consultation||||||
16344|NCT01857882|Primary|Decision Self-efficacy Scale|"Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.~The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).~The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation."|Change from baseline decision self-efficacy at 1 week after surgical consultation|||units on a scale||Standard Deviation|Mean
16345|NCT01857713|Other Pre-specified|Investigator Questionnaire|Investigators provide their perception of the device at the end of the study.|4 Weeks||||||
16346|NCT01857713|Other Pre-specified|Patient Satisfaction|Patients provide their perception of the device at the end of the study.|4 Weeks||||||
16347|NCT01857713|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).||Change in Units on a Scale||Standard Deviation|Mean
16348|NCT01857713|Secondary|SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).||Change in Units on a Scale||Standard Deviation|Mean
16349|NCT01857713|Primary|Primary Safety|Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.|4 Week Follow-up|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).||% Reporting Any Adverse Event|||Number
16350|NCT01857713|Primary|Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks|The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).|4 Weeks minus Baseline|||Per Cent Change||Standard Deviation|Mean
16351|NCT01857622|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)|3 months|||percentage of subjects with bleeds||95% Confidence Interval|Number
16352|NCT01857583|Secondary|Incidence of Adjudicated Thromboembolic Events|Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).|1 month||||||
16353|NCT01857583|Primary|Plasma Concentration of D21-2393||14 days||||||
16354|NCT01857583|Primary|Plasma Concentration of DU-176b||14 days||||||
16355|NCT01857583|Primary|Incidence of Adverse Drug Reactions||1 month||||||
16356|NCT01857583|Primary|Incidence of Adverse Events||1 month||||||
41615|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban After Three Days of 15 mg IV Daily in HRS Type 1 Patients||3 days|||ng/mL||Standard Deviation|Mean
16357|NCT01857583|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).|14 days|The safety analysis set was defined as all subjects who were enrolled in the study, except for those who had significant GCP violations, who had not received the study drug, or who had no safety data after the start of study treatment.||percentage of subjects with bleeds||95% Confidence Interval|Number
16358|NCT01857531|Other Pre-specified|Number of Participants Completing Abstinence From Smoking During the Last Four Weeks of Treatment|End of treatment abstinence from smoking during the last four weeks of treatment, based on self-reported abstinence during last four weeks confirmed by expired air CO|4 Week abstinence from smoking at 6 weeks post quit|||participants||95% Confidence Interval|Number
16359|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 6-week Abstinence From Smoking|Continuous six week abstinence from smoking at final study visit (approximately 6 weeks post quit date), based on self-reported abstinence confirmed by expired air CO|6 Weeks post quit|Because 6-week abstinence is counted backward from the final study visit, one additional subject (n=4) qualified as abstinent than at 2-weeks post-quit (n=3) due to the fact that the day(s) that one of the subjects smoked did not fall into the range evaluated at 6 weeks.||participants||95% Confidence Interval|Number
16360|NCT01857531|Other Pre-specified|Number of Participants Completing Point Abstinence From Smoking Two Weeks After Quitting|Point abstinence from smoking two weeks post quit, based on self-reported abstinence during last seven days confirmed by expired air CO at first post-quit visit.|7 day point abstinence from smoking at 2 weeks post quit|||participants||95% Confidence Interval|Number
16361|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 2-week Abstinence From Smoking|Continuous two week abstinence from smoking at the first post-quit visit (approximately 2 weeks post quit date), based on self-reported abstinence confirmed by expired air CO.|2 Weeks post quit|||participants||95% Confidence Interval|Number
16362|NCT01857531|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4|To evaluate the effects of ganaxolone as an augmentation treatment in conjunction with nicotine patch by looking at the percent change in expired air CO at the end of week four (relative to baseline).|Baseline and 4 Weeks|Three of the original 16 subjects dropped out prior to week 4, so only 13 subjects had a week 4 CO reading and could be included in this analysis.||percentage change||Standard Error|Mean
16363|NCT01857531|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2|To evaluate the effects of ganaxolone on ad lib smoking by looking at the percent change in expired air CO at the end of week two (relative to baseline).|Baseline and 2 Weeks|||percentage change||Standard Error|Mean
16364|NCT01857362|Primary|The Maximum Serum Concentration (Cmax).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.||nM||Full Range|Geometric Mean
16365|NCT01857362|Primary|The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.||uM*h||Full Range|Geometric Mean
16366|NCT01857323|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 50|Safety population||participants|||Number
16367|NCT01857323|Secondary|Absolute Value of Total Discrepancy Size Per Inhaler|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome is calculated for each inhaler as “beginning counter reading minus end counter reading” minus “patient-recorded number of dose cycles. The total inhaler discrepancy size is an important measure because it provides the most relevant means of ensuring that the inhaler does not exhaust its supply of albuterol before the counter has recorded the labeled 200 doses."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/inhaler||Standard Deviation|Mean
16368|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Up Unknown Dose Cycle|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter counts upwards (number increases, e.g. 50 to 52) rather than downward between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is greater than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
16384|NCT01857258|Primary|Area Under the Curve of Blood Glucose|Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose|||mmol/L * min||Standard Error|Mean
41616|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban After Three Days of 15 mg IV Daily in HRS Type 1 Patients||3 days|||hr||Standard Deviation|Mean
16369|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Unknown Dose Cycle|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter advances (decreases, e.g., 50 to 48) between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is less than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
16370|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Count Up|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter reading increases, instead of decreases, after the participant has executed the dose cycle (i.e., the ending counter reading is greater than the beginning counter reading within a dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
16371|NCT01857323|Primary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Not Count|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not advance (i.e., does not count down) within a dosing session. The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.||discrepancies/200 dose cycles|Participants||Number
16372|NCT01857297|Secondary|Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs include AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
16373|NCT01857297|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
16374|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2 and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
16375|NCT01857297|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||fold increase||Standard Deviation|Geometric Mean
16376|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
16377|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||60 min (baseline)|||nmol/umol||Standard Error|Mean
16378|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||0 min (baseline)|||nmol/umol||Standard Error|Mean
16379|NCT01857258|Secondary|Malondialdehyde||60 min postprandially|||uM||Standard Error|Mean
16380|NCT01857258|Secondary|Malondialdehyde (0 Min)||Baseline (0 min)|||uM||Standard Error|Mean
16381|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||60 min|||% dilation||Standard Error|Mean
16382|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||0 min (baseline)|||% dilation||Standard Error|Mean
16383|NCT01857258|Primary|Area Under the Curve of Brachial Artery Flow Mediated Dilatiion|Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose|||%FMD * min||Standard Error|Mean
16385|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.||Subjects|||Number
16386|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.||Subjects|||Number
16387|NCT01857206|Primary|Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 7 after any vaccination|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.||Subjects|||Number
16388|NCT01857063|Secondary|Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed. The possible Sneezing Score ranged from 0 to 4, with a higher score indicating more severe sneezing. The Sneezing Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16389|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge.The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16390|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16391|NCT01857063|Secondary|Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16392|NCT01857063|Secondary|Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16393|NCT01857063|Secondary|Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16394|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16395|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16396|NCT01857063|Secondary|Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16397|NCT01857063|Primary|Percentage of Participants Who Experience at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.|Up to 5 weeks|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
16398|NCT01857063|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.||score on a scale||95% Confidence Interval|Least Squares Mean
16399|NCT01856933|Secondary|Toxicities (Adverse Events) of PSMA ADC for Patients With Recurrent Glioblastoma.||at least every 3 weeks for a maximum of 30 post coming off drug, approximtely 6 months||||||
16400|NCT01856933|Primary|Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.|"The response assessment in neuro-oncology (RANO) will be used to define radiographic response.~(PD): A >25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|3 months until progression, potentially up to 1 year|Progression||participants|||Number
16401|NCT01856764|Secondary|Change From Baseline to Day 15 in Participants’ Assessment of Pruritus|Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.||Scores on a scale||Standard Error|Least Squares Mean
16402|NCT01856764|Secondary|Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values|Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.||g/m^2/hr||Standard Error|Least Squares Mean
16403|NCT01856764|Primary|Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)|Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.||Scores on a scale||Standard Error|Least Squares Mean
16407|NCT01856686|Other Pre-specified|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements|Up to 8 months|||participants|||Number
16408|NCT01856686|Other Pre-specified|Body Mass Index at 3 Months|Body mass index after 3 months of dietary approach.|3 months|||kg/m2||Standard Deviation|Mean
16409|NCT01856686|Secondary|Behavior|"Behavior assessed by total score of clinical questionnaire (sum of Hyperactivity, Impulsivity and Inattention scores), after 3 months of nutritional approach.~Range: minimum value: 0 and maximum value: 25. Higher values represent a worse outcome."|3 months|||units on a scale||Standard Deviation|Mean
16410|NCT01856686|Primary|Frontal Midline Theta Activity- Amplitude at 3 Months|Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||microvolts||Standard Deviation|Mean
16411|NCT01856686|Secondary|Monastra Ratio at 3 Months|Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||ratio||Standard Deviation|Mean
16412|NCT01856686|Primary|Mu Waves-amplitude at 3 Months|Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||microvolts||Standard Deviation|Mean
16413|NCT01856686|Secondary|Frontal Midline Theta Activity- Frequency at 3 Months|Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
16414|NCT01856686|Secondary|Mu Wave Frequency at 3 Months|Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
16415|NCT01856686|Other Pre-specified|Weight at 3 Months|Weight after 3 months of dietary approach.|3 months|||kilograms||Standard Deviation|Mean
16416|NCT01856686|Secondary|Parietal Alpha Waves-frequency at 3 Months|Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
16417|NCT01856686|Primary|Occipital Alpha Brainwaves Amplitudes at 3 Months|occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||microvolts||Standard Deviation|Mean
16418|NCT01856686|Secondary|Occipital Alpha Waves-frequency at 3 Months|occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||Hz||Standard Deviation|Mean
16419|NCT01856686|Primary|Comission Errors at 3 Months|comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)|3 months|||errors||Standard Deviation|Mean
16420|NCT01856686|Primary|Omission Errors at 3 Months|Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes)|3 months|||errors||Standard Deviation|Mean
16421|NCT01856686|Primary|Reaction Time at 3 Months|Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months|||milliseconds||Standard Deviation|Mean
16422|NCT01856673|Secondary|Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction|"TMHS scale of 64 items, ranging from 0 for “never” to 3 for “all the time” being the option three the worst condition, including locally relevant symptoms and sub-scales of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (PTSS) (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).~The Dysfunction measure was a gender-specific questionnaire with 12-items for females and 10-items for males. Each item assessed a task ranging from 0 for “no difficulty” to 4 for “cannot do it”, being the option four the worst condition.~For each scale, the mean was calculated in order to used it as the measure for comparisions.~Mean difference in scores of TMHS and Dysfunction between the subject’s baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.|||units on a scale||95% Confidence Interval|Mean
16423|NCT01856673|Primary|Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.|"Symptoms, ranging from 0 for “never” to 3 for “all the time” being three the worst score, were assessed with adapted versions of Hopkins Symptom Checklist and Harvard Trauma Questionnaire, from which they were analyzed the constructs of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).~For each scale, the mean was calculated in order to used it as the measure for comparisions.~Mean difference in scores of symptoms of anxiety, depression and post-traumatic stress disorders between the subject’s baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.|||units on a scale||95% Confidence Interval|Mean
16424|NCT01856530|Secondary|Perceived Rejection Scores on a 1-7 Likert Scale|Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in this analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
16425|NCT01856530|Secondary|Perceived Preference Scores on a 1-7 Likert Scale|Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
16426|NCT01856530|Secondary|Perceived Empathy Scores on a 1-7 Likert Scale|Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
16427|NCT01856530|Secondary|Perceived Trust Scores on a 1-7 Likert Scale|Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.||units on a scale||Standard Deviation|Mean
16428|NCT01856530|Primary|Disengagement From Social Threat Cues|The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement.|Day 1 (first day oxytocin or placebo was administered)|||Milliseconds||Standard Deviation|Mean
16429|NCT01856530|Primary|Social Cooperation|"The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as Player 2) played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1."|Day 1 (first day oxytocin or placebo was administered)|Data from 2 participants could not be analyzed due to technical difficulties with the computer task. Thus, the number of participants analyzed was 52 in total, rather than 54.||Ball tosses||Standard Deviation|Mean
16430|NCT01856322|Primary|Difference in Circulating S100A4 Transcript in Patients Receiving Sulindac 150 mg BD (Twice Daily) by Mouth Following Resection of Colorectal Cancer Metastases Compared to Those Who do Not.|Difference in circulating S100A4 transcript levels will be determined by assessing the circulating S100A4 transcript level at initial presentation versus the circulating S100A4 transcript level post resection.|3 years|The trial was prematurely closed due to lack of accrual, thus the outcome measure was not met.|||||
16431|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.||participants|||Number
16432|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|CN Population.||participants|||Number
16433|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.||participants|||Number
16434|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||participants|||Number
16435|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|CN Population.||participants|||Number
16436|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|GT Population.||participants|||Number
16437|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||participants|||Number
16556|NCT01854632|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)||Through 7 to 8 months post vaccination|All participants meeting per-protocol analysis criteria.||percentage of participants|||Number
16438|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||participants|||Number
16439|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|GT Population.||participants|||Number
16440|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.||participants|||Number
16441|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.||participants|||Number
16442|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.||participants|||Number
16443|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population.||participants|||Number
16444|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||participants|||Number
16445|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||participants|||Number
16446|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||participants|||Number
16447|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||participants|||Number
16448|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||participants|||Number
16499|NCT01855945|Primary|Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
16557|NCT01854593|Secondary|Silicon Oil Tamponade|The number of participants with silicon oil tamponade at the end of the surgery.|End of surgery.|||participants|||Number
16449|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16450|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16451|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.||beta coefficient|||Number
16452|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.||beta coefficient|||Number
16453|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16454|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16455|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.||beta coefficient|||Number
16456|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.||beta coefficient|||Number
16558|NCT01854593|Secondary|Gas Tamponade|The number of participants with gas tamponade at the end of the surgery.|End of surgery.|||participants|||Number
16559|NCT01854593|Secondary|Elevated Intraocular Pressure|The number of participants with elevated intraocular pressure after surgery.|Within 1 month after the surgery.|||participants|||Number
16457|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16458|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16459|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||beta coefficient|||Number
16460|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||beta coefficient|||Number
16461|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.||beta coefficient|||Number
16462|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Genetic Data Quality Check (GT) Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check.||beta coefficient|||Number
16463|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16464|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals; the analysis only included a subset of participants who provided evaluable data.||beta coefficient|||Number
16465|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.||beta coefficient|||Number
16466|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||beta coefficient|||Number
16467|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.||beta coefficient|||Number
16468|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check.||beta coefficient|||Number
16469|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.||beta coefficient|||Number
16470|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||beta coefficient|||Number
16560|NCT01854593|Secondary|Postoperative Neovascular Glaucoma|The number of participants with progressive or persistent neovascular glaucoma after surgery.|Within 1 month after the surgery.|||participants|||Number
16471|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.||beta coefficient|||Number
16472|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.||beta coefficient|||Number
16473|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||beta coefficient|||Number
16474|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||beta coefficient|||Number
16475|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||beta coefficient|||Number
16476|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model|GWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||beta coefficient|||Number
16477|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.||beta coefficient|||Number
19208|NCT01790178|Primary|Amount of Tissue Obtained|This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).|At time of biopsy|||grams||Standard Deviation|Mean
16478|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check.||beta coefficient|||Number
16479|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.||beta coefficient|||Number
16480|NCT01855997|Primary|Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model|Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to haplotype map (HapMap) version 3.0 reference individuals.||beta coefficient|||Number
16481|NCT01855958|Primary|Conditioned Pain Modulation (CPM) After Intervention.|"PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject.~# Below the data after intervention."|Before and within one hour after intervention.|||Kgf / cm2||Standard Deviation|Mean
16482|NCT01855958|Secondary|Cortical Silent Period (CSP) After Intervention.|"To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject.~# Below the data after intervention."|Evaluated before and within one hour after intervention.|||ms (milliseconds).||Standard Deviation|Mean
16483|NCT01855958|Secondary|Intracortical Facilitation (ICF) After Intervention.|"ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP.~# Below the data after intervention."|Before and within one hour after intervention.|||ratio of amplitude (mV).||Standard Deviation|Mean
16484|NCT01855958|Primary|Motor Evoked Potential (MEP) After Intervention.|"Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag–AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was deﬁned as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials.~MEP was deﬁned as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP).~# Below the data after intervention."|Before and within one hour after intervention.|||mV (millivolts).||Standard Deviation|Mean
16485|NCT01855958|Primary|Pain Pressure Threshold (PPT) After Intervention..|"PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes.~# Below, the data after intervention."|Before and within one hour after intervention.|||Kgf / cm2||Standard Deviation|Mean
16486|NCT01855958|Secondary|Pain Intensity After Intervention.|"The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm).~# Below the data after intervention."|Evaluated within twenty four hours before and within one hour after the intervention.|||cm ( mean).||Standard Deviation|Mean
41617|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban Acylglucuronide After Three Days of 5 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
16487|NCT01855958|Secondary|Intracortical Inhibition (ICI) After Intervention.|"ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP.~# Below the data after intervention."|Evaluated in one day. The cortical excitability before and within an hour after intervention.|||ratio of amplitude (mV).||Standard Deviation|Mean
16488|NCT01855945|Secondary|GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.|Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.||Ratios||95% Confidence Interval|Geometric Mean
16489|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
16490|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
16491|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years.~Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
16492|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.|Day 183 and Day 366 post vaccination|Analysis was done on the full analysis set.||Percentages of Subjects||95% Confidence Interval|Number
16493|NCT01855945|Secondary|Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.|Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.||Ratios||95% Confidence Interval|Geometric Mean
16494|NCT01855945|Secondary|Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).|The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.|Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination|Analysis was done on Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
16495|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.~Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.||Percentages of Subjects||95% Confidence Interval|Number
16496|NCT01855945|Primary|Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|"The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported.~The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported."|Day 1 through Day 366|Analysis was done on unsolicited safety dataset i.e. all subjects in the exposed population who have post-vaccination unsolicited adverse event records.||Number of subjects|||Number
16497|NCT01855945|Primary|Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
16498|NCT01855945|Primary|Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
16500|NCT01855945|Primary|Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.||Number of Subjects|||Number
16501|NCT01855919|Secondary|Percentage of Participants With Fall Events in Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
16502|NCT01855919|Secondary|Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.||percentage of participants|||Number
16503|NCT01855919|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14|WPAI is a self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores: Absenteeism (work time missed)=Question (Q)2/(Q2+4))*100); Presenteeism (impairment at work/reduced on-the-job effectiveness)=(Q5/10)*100); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100); and Activity Impairment=(Q6/10)*100. Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||hours||Standard Error|Least Squares Mean
16504|NCT01855919|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3 level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF.||units on a scale||Standard Error|Least Squares Mean
16505|NCT01855919|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14|SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
16506|NCT01855919|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14|BDI-II is a 21-question multiple-choice self-reported inventory about depressive symptoms (sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping patterns, irritability, changes in appetite, concentration difficulties, tiredness or fatigue, and loss of interest in sex). The scores for each item range from 0 (best) to 3 (worst) with possible total scores of 0 to 63, where higher total scores indicate more severe depressive symptoms. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
16507|NCT01855919|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
16508|NCT01855919|Secondary|Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10(worst pain) to determine average pain in the past 24 hours (average pain). Participants were considered to have sustained pain reduction of ≥30% in the BPI-severity score (average pain) at the time of final evaluation and at least 1 other time point prior to the time of final evaluation compared with baseline, and a reduction of ≥20% from baseline sustained at all evaluation time points between that period. Percentage of participants = (number of participants with sustained pain reduction / total number of participants in treatment group) * 100.|Baseline through Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||percentage of participants|||Number
16561|NCT01854593|Secondary|Best Corrected Visual Acuity Change|"Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.~The higher values represent a worse outcome."|1 month|||LogMAR||Standard Deviation|Mean
16509|NCT01855919|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.||percentage of participants|||Number
16510|NCT01855919|Secondary|Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. For the analysis, weekly mean was calculated. LS means calculated using MMRM adjusted for treatment, week, interaction between treatment and week as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
16511|NCT01855919|Secondary|Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores range from: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores range from: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference is defined as the average of non-missing scores of individual interference items. Higher scores indicated worsening of pain. LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
16512|NCT01855919|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14|The RMDQ-24 is a health status measure completed by participants to assess physical disability due to low back pain. Participants answered 24 questions about impairment of daily living activities (standing, walking, sitting, wearing clothes, working, etc.) resulting from low back pain. The number of statements marked was summed by the clinician for a total score. The total scores range from 0 (no disability) to 24 (severe disability). LS means calculated using analysis of covariance (ANCOVA) with treatment group as a fixed effect, and baseline value as a covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.||units on a scale||Standard Error|Least Squares Mean
16513|NCT01855919|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 14|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
16514|NCT01855919|Primary|Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.||units on a scale||Standard Error|Least Squares Mean
16515|NCT01855074|Secondary|Extrapyramidal Symptom Rating Scale (ESRS) Score|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, absent) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 26|Safety set (SS) population (N=79) included all participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
16516|NCT01855074|Secondary|Patient Satisfaction With Treatment|Participants’ were assessed for their satisfaction with the current antipsychotic treatment on a 5-point scale/questionnaire: very good, good, reasonable, moderate or poor.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Participants|||Number
16517|NCT01855074|Secondary|Global Assessment of Functioning (GAF) Score|The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
16562|NCT01854593|Secondary|Postoperative Best Corrected Visual Acuity|"Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.~The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome."|1 mouth after surgery.|||LogMAR||Standard Deviation|Mean
16563|NCT01854593|Secondary|Surgical Time||End of surgery.|||minutes||Standard Deviation|Mean
16518|NCT01855074|Secondary|Short Form-36 (SF-36) - Quality of Life Score|The SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: vitality, physical function, social function, physical role, emotional role, bodily pain, general health, mental health. Each item is scored on a scale ranging from 0-100 (100=highest level of functioning).|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
16519|NCT01855074|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
16520|NCT01855074|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. Change at Week 26 score is calculated as Baseline score minus Week 26 score.|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.||Units on a scale||Standard Deviation|Mean
16521|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
16522|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation."|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
16523|NCT01854944|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
16524|NCT01854944|Secondary|Mean Change From Baseline in PANNS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
16525|NCT01854944|Secondary|Mean Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety sample included participants that are administered at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
16535|NCT01854944|Primary|Change in Percentage 5-HT2A Receptor Occupancy|Mean (±SD) Serotonin 5-HT2A Receptor Occupancy Using the Radiotracer [11C]MDL100907 (in low and high dose). The 5-HT2A receptors following administration of 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline and 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
16564|NCT01854593|Secondary|Iatrogenic Retinal Tears|The number of participants who had intraoperative iatrogenic retinal tears.|End of surgery.|||participants|||Number
16526|NCT01854944|Secondary|Percentage of Participants Who Reported at Least One Occurrence of Suicidality, Suicidal Behavior and Suicidal Ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25, with a higher score indicating a worse outcome. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale. Last Visit is last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Last Visit|The safety population included all participants who received at least one dose of study medication.||Percentage of participants|||Number
16527|NCT01854944|Secondary|Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The BARS total score (when combined) ranged from 0 to 18, with higher values indicating a severe condition.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
16528|NCT01854944|Secondary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40, with higher scores indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on scale||Standard Deviation|Mean
16529|NCT01854944|Secondary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, with a higher score indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
16530|NCT01854944|Secondary|Time to Maximum (Peak) Plasma Concentration (Tmax) for Brexpiprazole and Its Metabolite DM-3411|Tmax for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.||hour||Full Range|Median
16531|NCT01854944|Secondary|Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F; Only Brexpiprazole)|PK parameter - CL/F was assessed for brexpiprazole only. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.||mL/hr||Standard Deviation|Mean
16532|NCT01854944|Secondary|Peak (Maximal) Concentration of Drug in Plasma (Cmax) for Brexpiprazole and Its Metabolite DM-3411|(Cmax) Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.||ng/mL||Standard Deviation|Mean
16533|NCT01854944|Secondary|Area Under the Concentration-time Curve (AUCτ) During a Dosing Interval at Steady-state for Brexpiprazole and Its Metabolite DM-3411|AUC during a dosing interval at steady-state for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at early termination (ET).||hr*ng/mL||Standard Deviation|Mean
16534|NCT01854944|Primary|Change in Occupancy at Serotonin Transporter (SERT)|Mean (±SD) SERT Occupancy Using the Radiotracer [11C]DASB in high dose only. Occupancy estimates were averaged across brain regions 4 hours post-last dose.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
16547|NCT01854632|Secondary|Etiologies of Influenza-like Illness in the Study Population|Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.|Through 7 to 8 months post vaccination||||||
16536|NCT01854944|Primary|Change in Percentage 5-HT1A Receptor Occupancy|Mean (±SD) Serotonin 5-HT1A Receptor Occupancy Using the Radiotracer [11C]CUMI101 in high dose only. In cohorts 1, 2 and 3, the binding of brexpiprazole to the 5-HT1A receptors was assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The 5-HT1A receptors following administration of a 4-mg dose of brexpiprazole was assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
16537|NCT01854944|Primary|Change in Percentage Dopamine D2/D3 Receptor Occupancy|Dopamine receptor occupancy measured using the radiotracer [11C]-(+)-PHNO in low and high dose. The binding of brexpiprazole to the D2/D3 receptors were assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The D2/D3 receptors following administration of a 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The positron emission tomography (PET) analysis included all participants who had both the Baseline and Day 10 PET scans performed.||percentage occupancy||Standard Deviation|Mean
16538|NCT01854905|Primary|Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale|The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress|Day 1|All enrolled patients||Percentage of Patients|||Number
16539|NCT01854697|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
16540|NCT01854697|Secondary|Percentage of Participants With Post-treatment Relapse|Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment.|Within 24 weeks post treatment|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and had sustained virologic response at Week 24 (SVR24).||percentage of participants|||Number
16541|NCT01854697|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:~Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment~Failure to achieve HCV RNA < LLOQ by Week 6 or~Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.~Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:~HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV~HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV~Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV~Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV."|12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
16542|NCT01854697|Secondary|Percentage of Participants With SVR12 - Secondary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
16543|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)|SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.||units on a scale||Standard Deviation|Mean
16544|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)|SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.||units on a scale||Standard Deviation|Mean
16545|NCT01854697|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
16546|NCT01854632|Secondary|Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection|Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.|Through 4 days post vaccination||||||
16548|NCT01854632|Secondary|Clinical Characteristics of Influenza in the Study Population||Through 7 to 8 months post vaccination||||||
16570|NCT01854528|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)|ITT population.||percentage of participants||95% Confidence Interval|Number
16571|NCT01854528|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment.|Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)|ITT population.||percentage of participants||95% Confidence Interval|Number
16572|NCT01854528|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|24 weeks after the last dose of study drug|All participants in the ITT population with evaluable data.||percentage of participants|||Number
16573|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey – Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
16574|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey – Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
16575|NCT01854528|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last dose of study drug|ITT population: All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
16576|NCT01854281|Primary|Arterial Nitrogen Bubbles After Surfacing|Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.|assesed within 1 hour after surfacing|||participants|||Number
16577|NCT01854268|Secondary|Urge-to-cough|Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).|1 hour|||units on a scale||Standard Error|Median
16578|NCT01854268|Secondary|Peak Expiratory Airflow Rate|Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second.|1 hour|||Liters/second||Standard Deviation|Mean
16579|NCT01854268|Primary|Lung Volume Initiation|Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.|1 hour|25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease.||% Vital Capacity, relative to EEL||Standard Deviation|Mean
16580|NCT01854242|Primary|Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease|Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table.|2 weeks|||participants testing positive|||Number
16581|NCT01853982|Primary|Clinical Response at the End of Therapy Visit||24 hours after last dose of study drug|There is no analysis population or data available for this measure. This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.|||||
16582|NCT01853839|Secondary|Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)|Number of participants with adverse events in participants receiving Angiotensin II (Type 1) Receptor Blockers (ARBs) when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration.|Up to 52 weeks|All subjects who took a combination of ARB and CCB drugs.||participants|||Number
16583|NCT01853839|Secondary|The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at the end of the 1 year treatment duration. This variable was derived from the mean sitting blood pressure assessed by the investigators at the end of the 1 year treatment duration. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. At this timepoint, a diagnosis of diabetes mellitus and/or kidney disease was also taken into account. Subjects with either of the mentioned conditions had to have systolic blood pressure lower than 130 mm Hg and diastolic blood pressure below 80 mm Hg to satisfy JNC 7 treatment goals.|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
16584|NCT01853839|Secondary|The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in diastolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population||mmHg||Standard Deviation|Mean
16585|NCT01853839|Secondary|The Difference in Systolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in systolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population||mmHg||Standard Deviation|Mean
16586|NCT01853839|Secondary|Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician)|Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
16587|NCT01853839|Secondary|Compliance of Patients During the Whole Study Duration (52 Weeks)|"Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|Up to 52 weeks|Per-protocol population including all patients with data at 52 weeks||Percentage of participants|||Number
16588|NCT01853839|Secondary|Compliance of Patients up to 10 Days After Ramadan|"Compliance of patients up to 10 days after Ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days after Ramadan|Per-protocol population including all patients with data 10 days after Ramadan||Percentage of participants|||Number
16589|NCT01853839|Secondary|Compliance of Patients up to 10 Days Before Ramadan|"Compliance of patients up to 10 days before ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days before Ramadan|Per-protocol population including all patients with data 10 days before Ramadan||Percentage of participants|||Number
16590|NCT01853839|Secondary|The Overall Assessment of Treatment by Physicians at 52 Weeks|The overall assessment of treatment by physicians at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
16591|NCT01853839|Secondary|The Overall Assessment of Treatment by Patients at 52 Weeks|The overall assessment of treatment by patients at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population||Percentage of participants|||Number
16592|NCT01853839|Secondary|Cardiovascular Events|Percentage of participants who experienced a major cardiovascular (CV) event|Up to 52 weeks|All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria||Percentage of participants|||Number
16593|NCT01853839|Secondary|Achieving JNC 7 Treatment Goals After Ramadan|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting after Ramadan. This variable was derived from the mean sitting blood pressure assessed by the investigators after Ramadan. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|1 month|Per-protocol (PP) population which included all eligible patients who did not experience any protocol violation and were treated with the study medication up to week 52 (study completers) according to the prescribing information.||Percentage of participants|||Number
16594|NCT01853839|Primary|Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at week 52. This variable was derived from the mean sitting blood pressure assessed by the investigators at week 52. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria – systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|Up to 52 weeks|ITT dataset which included all patients, who received at least one dose of study medication.||Percentage of participants|||Number
16595|NCT01853696|Secondary|Immunologic Graft Rejection Episode|Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.|within first year after cornea transplantation|||eyes|Participants||Number
16596|NCT01853696|Primary|Intraocular Pressure|Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.|from 1 to 12 months after transplant|||eyes|Participants||Number
16597|NCT01853605|Primary|Local Complications|Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.||Percentage of Subjects||95% Confidence Interval|Number
16598|NCT01853605|Primary|Investigator Satisfaction With Breast Implants on a 5-Point Scale|Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.||Subjects|||Number
41618|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban Acylglucuronide After Three Days of 5 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
16599|NCT01853605|Primary|Subject Satisfaction With Breast Implants on a 5-Point Scale|Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.||Subjects|||Number
16600|NCT01853475|Secondary|Piperaquine AUC0-inf|Area under the Piperaquine plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
16601|NCT01853475|Secondary|Piperaquine Cmax|Piperaquine maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
16602|NCT01853475|Primary|OZ439 AUC0-inf|Area under the OZ439 plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
16603|NCT01853475|Primary|OZ439 Cmax|OZ439 maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
16604|NCT01853397|Secondary|Subject Satisfaction With Treatment|Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater (‘satisfied’ or ‘very satisfied’).|4, 8, 12, and 16 weeks|Intent-to-treat||percentage of subjects satisfied|||Number
16605|NCT01853397|Secondary|Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of ‘Improved’ or ‘Much Improved’.|4, 8, 12, and 16 weeks|Intent-to-treat||percentage of subjects improved|||Number
16606|NCT01853397|Secondary|Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|"GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area.~Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of ‘Improved’ or ‘Much Improved’."|4, 8, 12, and 16 weeks|Intent-to-treat||Percentage of subjects improved|||Number
16607|NCT01853397|Secondary|Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.|4 weeks, 8 weeks, 16 weeks|Intent-to-treat||cm||Standard Deviation|Mean
16608|NCT01853397|Primary|Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.|12 weeks|Intent-to-treat||cm||Standard Deviation|Mean
16609|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||mm||Standard Error|Least Squares Mean
16610|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||mm||Standard Error|Least Squares Mean
16611|NCT01853384|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.|Due to study termination the data available to assess durability of closure were limited to only the subjects who completed at least one of the follow-up visits. Participants who had CLOSED wounds at completion of treatment; 103 subjects (HP802-247: 49; Vehicle: 54) completed Visit 18, 114 subjects (HP802-247: 57; Vehicle: 57) completed Visit 19||participants|||Number
16633|NCT01853085|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure||Patients|||Number
16612|NCT01853384|Secondary|Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline|For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05||percentage of participants|||Number
16613|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier Survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using Kaplan-Meier Survival analysis, with significance being at P < 0.05.||days||95% Confidence Interval|Median
16614|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05.||days||Full Range|Median
16615|NCT01853384|Primary|Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|"For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed.~For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed."|Weekly, over 12 Weeks or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article.||participants|||Number
16616|NCT01853371|Primary|Diastolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
16617|NCT01853371|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.~Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month||||||
16618|NCT01853371|Primary|Systolic Blood Pressure After 4 Weeks||1 month|||mmHg||Standard Deviation|Mean
16619|NCT01853254|Primary|Percentage of Participants With at Least 1 Adverse Event||From Baseline to the end of the study (up to 72 weeks)|All participants analysis set.||Percentage of participants|||Number
16620|NCT01853215|Secondary|300mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
16621|NCT01853215|Secondary|200mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
16622|NCT01853215|Secondary|100mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
16623|NCT01853215|Secondary|Gravity Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).|during the 12 minute infusion time frame|Per protocol||milliliters per hour||Standard Deviation|Mean
16624|NCT01853215|Secondary|Adhesion Strips|Perceived effeciveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; $=Very good; 5=Excellent.|During insertion of the intraosseous needle set|||Likert scale||Standard Deviation|Mean
16625|NCT01853215|Secondary|Stability of Catheter Hub|Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy.|During insertion of the intraosseous needle set|||Likert scale||Standard Deviation|Mean
16626|NCT01853215|Secondary|Stability of Locator|"Operator's perceived stability of the sternal locator once placed on the subject.~1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent."|During insertion of the intraosseous needle set|Per protocol||Likert scale||Standard Deviation|Mean
16627|NCT01853215|Primary|Occurrences of Extravasation During Infusion|The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.|during 12 minutes of infusion|Per protocol||participants|||Number
16628|NCT01853176|Primary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.|3 days||||||
16629|NCT01853085|Primary|IOP in the Study Eye at Week 12|IOP is a measurement of the fluid pressure inside the study eye.|Week 12|All patients with data for this outcome measure||mmHg||Standard Deviation|Mean
16630|NCT01853085|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure||Patients|||Number
16631|NCT01853085|Secondary|Number of Patients Who Continue Treatment|Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.|12 Weeks|All enrolled patients||Patients|||Number
16632|NCT01853085|Secondary|Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment|Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.|12 Weeks|All enrolled patients||Patients|||Number
18567|NCT01807624|Secondary|Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
16634|NCT01853085|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure||Patients|||Number
16635|NCT01853085|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.|Baseline, 12 Weeks|All patients with data for this outcome measure||Patients|||Number
16636|NCT01853085|Primary|Intraocular Pressure (IOP) in the Study Eye at Baseline|IOP is a measurement of the fluid pressure inside the study eye.|Baseline|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
16637|NCT01853072|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
16638|NCT01853072|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]||Day 7 up to any visit through Day 90|Full analysis set||percentage of participants|||Number
16639|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set||Percentage of participants|||Number
16640|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set||Percentage of participants|||Number
16641|NCT01853072|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set||Percentage of participants|||Number
16642|NCT01853072|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set||Percentage of participants|||Number
16643|NCT01852955|Secondary|Postoperative Pain in the Post Anesthesia Care Unit|Postoperative pain within the post anesthesia care unit after surgery. Area under the numeric rating scale for pain versus time curve in the post anesthesia care unit (score * min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). Area under a curve units of the horizontal axis multiplied by the units of the vertical axis. A higher value indicates more pain and time in the Post Anesthesia Care Unit.The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|Time in the post anesthesia care unit after surgery (average of 5 hours)|||(units on a scale * minutes||Inter-Quartile Range|Median
16644|NCT01852955|Secondary|Postoperative Opioid Consumption|Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents.|24 hour|||oral mg of morpine equivalents||Inter-Quartile Range|Median
16645|NCT01852955|Primary|Quality of Recovery at 24 Hours(QoR-40 Instrument)|Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).|24 hours after the surgical procedure|||units on a scale||Inter-Quartile Range|Median
16646|NCT01852825|Secondary|Change From Baseline in Time Weighted Average (TWA) Over 1 Hour Pre-NAC Through 1 Hour Post-NAC Visual Analog Score (VAS) for Sneezing, Rhinorrhea, Congestion and Nasal Itch Following 12 Weeks of Treatment (Part 2)|A visual analog scale (VAS) representing the spectrum of symptoms from absent (0) to extremely severe (100) for each of rhinorrhea, nasal blockage, sneezing and nasal itch were summed to obtain an overall score. The range of VAS overall score is 0 - 400, with higher numbers representing worse symptoms. The models for the time-weighted mean (TWA) of the summed scores over 1 hour pre-NAC through hour 1 following NAC were constructed at the original scale.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Score on a scale||95% Confidence Interval|Least Squares Mean
16647|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Nasal Epithelial Eosinophil-related Messenger RNA (mRNA) Signature Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of nasal epithelial eosinophil-related mRNA signature 6.5 hours after NAC in serum at baseline and at week 12 were measured. The mRNA signature is derived from nine gene transcripts which were measured using the NanoString nCounter Gene Expression Assay. Positive control and pre-specified housekeeping gene normalization methods recommended by nSolver were used to normalize the transcripts. The average of the expression level of the nine genes was used to describe the eosinophil mRNA signature. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold change||95% Confidence Interval|Least Squares Mean
16671|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.|24 hours|||PRI%||Standard Error|Least Squares Mean
16672|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.|2 hours|||PRI%||Standard Error|Least Squares Mean
16648|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Interleukin-5 (IL-5) Protein Concentration in Nasal Exudates Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of Il-5 protein 6.5 hours after NAC in serum at baseline and at week 12 were measured. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. IL-5 protein concentration was measured in nasal exudates collected both pre- and post-nasal challenge. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold change||95% Confidence Interval|Least Squares Mean
16649|NCT01852825|Primary|Change From Baseline in HDM-specific IgE Blocking Factor (IgE-BF) in Serum at 12 Weeks|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the amount of IgE-BF in serum was measured based on an Ordinary IgE measurement and an assay in the presence of Competitors; with IgE-BF = 1 - (Competitive IgE/Ordinary IgE). This ranges from 0 (no IgE blocked) to 1 (all IgE blocked); and as it is based on a ratio there are no units. Change from baseline (12 weeks minus baseline) was evaluated based on cLDA method, and was analyzed based on the original scale. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the 1-tailed 95% CI around the 12 week mean difference in change from baseline in HDM-specific IgE blocking factor response excludes zero.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Ratio||95% Confidence Interval|Least Squares Mean
16650|NCT01852825|Primary|Change From Baseline in D. Pteronyssinus HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with D. pteronyssinus HDM, and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on cLDA method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold Change||95% Confidence Interval|Geometric Mean
16651|NCT01852825|Primary|Change From Baseline in D. Farinae HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with Dermatophagoides (D.) farinae HDM and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on constrained longitudinal data analysis (cLDA) method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.||Fold Change||95% Confidence Interval|Geometric Mean
16652|NCT01852812|Primary|Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||Hours||Standard Deviation|Mean
16653|NCT01852812|Primary|Time to Cmax (Tmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||Hours||Standard Deviation|Mean
16654|NCT01852812|Primary|Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||ng/mL||Standard Deviation|Mean
16655|NCT01852812|Primary|Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG|Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The All Subjects Pharmacokinetically Evaluable (ASPE) population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.||h*ng/mL||Standard Deviation|Mean
16673|NCT01852175|Primary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.|1 week|||PRI%||Standard Error|Least Squares Mean
16656|NCT01852812|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received.|Up to 12 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.||Percentage of participants|||Number
16657|NCT01852812|Primary|Percentage of Participants Who Experience at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received.|Up to 14 days after last dose of study drug (Up to 14 weeks)|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.||Percentage of participants|||Number
16658|NCT01852669|Primary|Number of Participants Who Are Stone Free at 3 Months|To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)|3 months|||participants|||Number
16659|NCT01852591|Secondary|CD8+CD107a+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.||percentage of CD8 cells|||Number
16660|NCT01852591|Secondary|CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30.|30 Days Post Vaccine|All evaluable participants.||percentage of CD8 cells|||Number
16661|NCT01852591|Secondary|CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.||percentage of CD4 cells|||Number
16662|NCT01852591|Primary|Number of Participants With Immune Response|Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.|30 Days Post Vaccine|All evaluable participants.||participants|||Number
16663|NCT01852383|Other Pre-specified|Maximum Duloxetine Oral Dose|Maximum duloxetine oral dose|Week 0, 1, 2, 4, 6, 8, 10, 12|||mg||Standard Deviation|Mean
16664|NCT01852383|Secondary|Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12|Cornell Dysthymia Rating Scale scores from range 0-64. Lower or decreasing scores represent decreased severity and a better outcome, while higher or increasing scores represent more severe depression and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Week 0 and 12|||units on a scale||Standard Deviation|Mean
16665|NCT01852383|Other Pre-specified|Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.|The Treatment Emergent Symptom Scale (TESS) documents the presence of common side effects. There are 26 items and the total score range is 0-26. Low scores or decrease in scores represent less side effects and high scores or increase in scores represent more side effects. The change in side effect severity scores was calculated by subtracting the Week 12 score from the Week 0 score.|0 and 12 weeks|||units on a scale||Standard Deviation|Mean
16666|NCT01852383|Primary|Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks.|The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit. Hamilton Rating Scale for Depression scores range from 0-50 with low scores or decreasing scores representing decreased severity and better outcome, and higher scores or increasing scores representing more severe depressive symptoms and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Screen (0) and 12 weeks|||units on a scale||Standard Deviation|Mean
16667|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|2 hours|||PRI||95% Confidence Interval|Least Squares Mean
16668|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|1 week|||PRI||95% Confidence Interval|Least Squares Mean
16669|NCT01852214|Secondary|P2Y12 Reaction Units|Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel)|2 hours|||PRU||95% Confidence Interval|Least Squares Mean
16670|NCT01852214|Primary|P2Y12 Reaction Units|The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence.|1 week|All analyses of platelet function conducted on all randomized subjects who received study drug, successfully completed at least one treatment period of the study and had valid data for the primary end point.||PRU||95% Confidence Interval|Least Squares Mean
16675|NCT01852162|Secondary|Clot Kinetic: Thrombin Activity|Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography||minutes||Standard Deviation|Mean
16676|NCT01852162|Secondary|Platelet Reactivity Measured by Multiple Electrode Aggregometry.|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry.|1-week|Platelet aggregation measured by multiple electrode aggregometry.||arbitrary aggregation units||Standard Deviation|Mean
16677|NCT01852162|Secondary|Platelet Reactivity Measured by LTA|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA).|1-week|Platelet aggregation measured by LTA||percentage of aggregation||Standard Deviation|Mean
16678|NCT01852162|Primary|TRAP-induced Platelet Aggregation|TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups|1 week|TRAP-induced platelet aggregation||percentage of aggregation||Standard Deviation|Mean
16679|NCT01852019|Secondary|Bleeding Events in Accordance With the GUSTO Scale|Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993].|Day 1 through Day 8|||participants|||Number
16680|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||platelet reaction units (PRU)||Standard Deviation|Mean
16681|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||platelet reaction units (PRU)||Standard Deviation|Mean
16682|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||% aggregation||Standard Deviation|Mean
16683|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.||% aggregation||Standard Deviation|Mean
16684|NCT01851876|Primary|Clinical Pregnancy Rate||4 months|||participants|||Number
16685|NCT01851876|Primary|Clinical Pregnancy Rate||up to 6 months||||||
16686|NCT01851863|Other Pre-specified|Number of Participants With Adverse Reaction|Number of participants with adverse reactions were recorded to analyze the safety profile of treatment.|8 weeks|||participants|||Number
16687|NCT01851863|Secondary|Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8|Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome.|week 0 and 8|||units on HADS score||Full Range|Mean
16688|NCT01851863|Secondary|Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8|The severity of patients’ dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and > 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome.|week 0 and 8|||units on LDQ scale||Full Range|Mean
18568|NCT01807624|Primary|AUC0-infinity of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||ng.h/mL||Standard Deviation|Mean
16689|NCT01851863|Primary|Compliance of Flupentixol-Melitracen|The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.|weeks 1, 2, 4, 8|||participants|||Number
16690|NCT01851772|Other Pre-specified|Frequency of Adverse Events in Participants (i.e.Safety)|To assess occurrence rate of radiation toxicities through three (3) months of follow-up.|3 months post-Study Exit|||participants|||Number
16691|NCT01851772|Secondary|Device Performance|Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.|Study Exit (90 days)|||participants|||Number
16692|NCT01851772|Primary|Safety|Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.|Study Exit (90 days)|Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA).||percentage of participants and severity|||Number
16693|NCT01851655|Other Pre-specified|Change in Anterior Knee Laxity|Anterior knee laxity will be assessed with a knee arthrometer and a maximum manual pull. The side-to-side difference will be recorded in mm. The change will be computed as (post-intervention difference minus pre-intervention difference).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||mm||Standard Deviation|Mean
16694|NCT01851655|Other Pre-specified|Change in Fear of Movement/Re-injury|The 11-item version of the Tampa Scale for Kinesiophobia will be used to assess kinesiophobia or fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores equal higher fear of movement/re-injury. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
16695|NCT01851655|Other Pre-specified|Change in Quadriceps Strength|Knee extensor torque will be measured with an isokinetic dynamometer. The lever arm will move at 60 degrees/second. The peak torque from 5 trials will be obtained and normalized to body weight. The change will be computed as (post-intervention value minus pre-intervention value)|Baseline (pre-intervention) to 9 weeks (post-intervention)|||ft-lb/lb||Standard Deviation|Mean
16696|NCT01851655|Secondary|Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.|CTX-II is a biomarker of Type II articular cartilage degradation. Type II collagen carboxy propeptide (CPII) is a biomarker of Type II collagen synthesis. Early morning urine and blood samples will be collected pre- and post-treatment. Urinary CTX-II will be analyzed as described in Primary Outcomes. Serum CPII will be determined using enzyme-linked immunosorbent assay. Values of both biomarkers will be log-transformed, and the ratio of CTXII:CPII will be calculated. The change will be computed as (post-intervention CTXII:CPII values minus pre-intervention CTXII:CPII value).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||log [(ng/mmol)/(ng/mL)]||Standard Deviation|Mean
16697|NCT01851655|Secondary|Change in Vertical Jump Height.|Vertical jump height will be assessed with the Vertex. The average of three trials will be recorded in cm. The change in vertical jump height will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||cm||Standard Deviation|Mean
16698|NCT01851655|Primary|Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||log-scale transformed value of ng/mmol||Standard Deviation|Mean
16699|NCT01851655|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Form Score.|The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)|||units on a scale||Standard Deviation|Mean
16700|NCT01851590|Secondary|Compliance to the Treatment|Evaluation of compliance was based on patient self-reports of whether the treatment protocol was followed 100% (complete), 80% (good), 60% (moderate), or 40% (poor) of the time.|At 4-month time-point|Percentage describes the proportion of patients who declared that they have been followed the instructions completely (100%).||percentage of participants|||Number
16701|NCT01851590|Secondary|Cost-effectiveness 2|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) during the treatment period per patient in each group.|At 10-month time-point|||Euros (€)||95% Confidence Interval|Mean
16702|NCT01851590|Secondary|Cost-effectiveness 1|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) per day per patient in each group.|At 10-month time-point|||Euros (€)||95% Confidence Interval|Mean
16703|NCT01851590|Secondary|Clinical Responses to the Treatments|Clinical responses to treatment were based on the proximal linear growth of healthy nail; thus, the clinical responses were classified as partial (evident proximal linear growth of healthy nail) or complete. Partial responses were defined as significant reductions in onycholysis, subungual hyperkeratosis, and streaks. A complete response was a fully normal appearance of the toenail.|At 4- and 10 months time-points from the beginning of the study.|Intention-to-treat population, last observation carried forward.||percentage of participants|||Number
16704|NCT01851590|Primary|Mycological Cure|To analyze the rate of complete mycological cure i.e. fungal eradication in terms of negative mycological culture AND negative potassium hydroxide (KOH) stain at 4- and 10 months time-points from the beginning of the study.|At 4- and 10 months time-points from the beginning of the study.|Primary and secondary outcome analyses were based on the intent-to-treat (ITT) population and missing values were imputed using the last observation carried forward (LOCF) method.||Percentage of participants||95% Confidence Interval|Number
16705|NCT01851330|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-Treatment Virologic Failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
16706|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with Available Data were analyzed.||log10 IU/mL||Standard Deviation|Mean
16707|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with Available Data were analyzed.||log10 IU/mL||Standard Deviation|Mean
16708|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with Available Data were analyzed.||log10 IU/mL||Standard Deviation|Mean
16709|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with Available Data were analyzed.||percentage of participants|||Number
16710|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with Available Data were analyzed.||percentage of participants|||Number
16711|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with Available Data were analyzed.||percentage of participants|||Number
16712|NCT01851330|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
16713|NCT01851330|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 12 weeks|Safety Analysis Set||percentage of participants|||Number
16714|NCT01851330|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study medication.||percentage of participants|||Number
16715|NCT01849562|Primary|Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection.|To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1, the following criteria will be used: the number of subjects with discontinuations due to AEs, treatment emergent G3/G4 AEs, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs.|12 weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug. For this study, the safety population and the FA set were the same.||participants|||Number
16716|NCT01849562|Primary|Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment.|Incidence of SVR4 after the completion of dosing, reported as HCV RNA less than the lower limit of quantification (<LLOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo.|Four weeks after the completion of treatment|The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized subjects who received at least one dose of study drug and had at least one baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same.||Percentage of Subjects with SVR4|||Number
16717|NCT01850589|Primary|Number of Participants With Smoking Cessation at 12 Months|Conservative vs. aggressive smoking strategies in treating smoking cessation.|12 months|Mean follow up was 7.3 months||Participants|||Number
16718|NCT01850550|Secondary|Dietary Intake|Assessed using the NCI Dietary History Questionnaire|12 weeks after initial consent||||||
16719|NCT01850550|Secondary|Physical Activity|Assessed by the International Physical Activity Questionnaire|12 weeks after initial consent||||||
16720|NCT01850550|Secondary|Blood Pressure|Blood pressure will be recorded using an OMRON automatic blood pressure cuff.|12 weeks after initial consent||||||
16721|NCT01850550|Secondary|BMI|Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.|12 weeks after initial consent|||kg/m^2||Full Range|Mean
16722|NCT01850550|Primary|Percent Change in Weight|We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.|12 weeks after initial consent|||percent weight change||Full Range|Mean
16723|NCT01850485|Secondary|SvO2|(venous oxygen saturation)|24 hours|||percent saturation||Standard Deviation|Mean
16724|NCT01850485|Secondary|Lactate|lactate levels in serum|24 hours|||mmol/l||Standard Deviation|Mean
16725|NCT01850485|Secondary|Cardiac Index|Cardiac Index is cardiac output indexed for body weight|24 hours|||L/m2||Standard Deviation|Mean
16726|NCT01850485|Secondary|Inotropes and Vasopressor Dose||baseline|||mcg/kg/min||Inter-Quartile Range|Median
16727|NCT01850485|Secondary|Fluid Balance After 24 Hours||24 hours|||liters||Standard Deviation|Mean
16728|NCT01850485|Secondary|RincStO2|tissue oxygenation measured by Near Infrared Spectroscopy|baseline|||percent saturation||Standard Deviation|Mean
16729|NCT01850485|Primary|Microvascular Flow Index (MFI)|Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)|baseline measurement|||units on a scale||Inter-Quartile Range|Median
16731|NCT01850394|Secondary|Number of Patients Having Postoperative Complications|"Postoperative complications were measured as an incidence of the following complications;~wound hematoma~surgical site infection~systemic infection~deep vein thrombosis~pulmonary embolism~knee stiffness requiring manipulation~medical complication such as myocardial infarction, congestive hear failure"|postoperative 1-year period|Using Intention-to-treat analysis||participants|||Number
16732|NCT01850394|Secondary|Number of Patients Required Blood Transfusion||postoperative period (5 days after surgery)|||participants|||Number
16733|NCT01850394|Secondary|Knee Function Scores|"Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.~Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.~1.2. Function score : calculated from patient’s ability to walk and climb stairs. The score ranges from 0-100, more score means better.~Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better."|1 year after surgery|Using intention-to-treat analysis||units on a scale||Standard Deviation|Mean
16734|NCT01850394|Primary|Perioperative Blood Loss|"Drainage blood loss measured by accumulating total drainage volume postoperatively~Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day"|5 days after surgery|Using intention-to-treat analysis||ml||Standard Deviation|Median
16735|NCT01849848|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks|||Events|||Number
16736|NCT01849848|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks|||participants|||Number
16737|NCT01849848|Secondary|Adverse Events|All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.|up to around 44 weeks|||participants|||Number
16738|NCT01849848|Secondary|Overall Survival (OS)|Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
16739|NCT01849848|Secondary|Duration of Response (DOR)|From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
16740|NCT01849848|Secondary|Time to Treatment Failure (TTF)|Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
16741|NCT01849848|Secondary|Progression-Free Survival (PFS)|Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated.|up to around 44 weeks|||Days||95% Confidence Interval|Median
16742|NCT01849848|Secondary|Response Rate (CR+PR) Based on the Blade Criteria|"The criteria for PR based on the Blade are shown below.~PR requires 1. or all of the others:~Some, but not all, of the criteria for CR are fulfilled~≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks~Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks~For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy~≥50% reduction in the size of soft tissue plasmacytomas~No increase in size or number of lytic bone lesions"|up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
16743|NCT01849848|Secondary|Complete Response (CR) Based on the Blade Criteria|"The criteria for CR based on the Blade are shown below.~CR requires all of the followings:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas"|up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
16744|NCT01849848|Secondary|Response Rate (sCR+CR) Based on IMWG Criteria||up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
16745|NCT01849848|Primary|Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria|"The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below.~sCR: Fulfills CR criteria as well as all of the following conditions~Normal free light chain (FLC) ratio(κ/λ)~Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~CR: Fulfills all of the following criteria~Negative immunofixation of serum and urine M-protein~<5% plasma cells in bone marrow~Disappearance of any soft tissue plasmacytoma~VGPR: Fulfills at least one of the following criteria~Serum and urine M-protein detectable by immunofixation but not electrophoresis~≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine <0.1 g/24 hour~PR: Fulfills the following criteria~≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to < 0.2 g/24hours"|up to around 44 weeks|||percentage of paticipants||95% Confidence Interval|Number
16747|NCT01849770|Secondary|Mean Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.~The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.~Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication|||units on a scale||95% Confidence Interval|Mean
16748|NCT01849770|Secondary|Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication|||ratio||95% Confidence Interval|Number
16749|NCT01849770|Secondary|Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication|||ratio||95% Confidence Interval|Number
16750|NCT01849770|Secondary|Maximal Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.~The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.~Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication|||units on a scale||95% Confidence Interval|Mean
16751|NCT01849770|Other Pre-specified|Change in Slow Vital Capacity (SVC) Score|The vital capacity (VC) (percent of predicted normal) will be determined, using the slow VC method. The SVC can be measured using conventional spirometers that have had a calibration check prior to subject testing. A printout from the spirometer of all SVC trials will be retained.|Week 0, Week 6, and Week 12 (or Early Termination Date)|||percent of predicted normal||95% Confidence Interval|Mean
16752|NCT01849770|Other Pre-specified|Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16|||scores on a scale||95% Confidence Interval|Mean
16753|NCT01849770|Secondary|Mean Weekly Cramp Frequency||Week 3-12, post titration of study medication|||cramps/week||95% Confidence Interval|Mean
16754|NCT01849770|Secondary|Mean Cerebrospinal Fluid (CSF)/Plasma Ratio|The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.|Week 6 Visit (up to 6 hours post dose)|||ratio||Standard Deviation|Mean
16755|NCT01849770|Secondary|Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (up to 6 hours post dose)|||µg*hr/mL||Standard Deviation|Mean
16756|NCT01849770|Secondary|Peak Plasma Concentration (Cmax) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)|||pg/mL||Standard Deviation|Mean
16757|NCT01849770|Secondary|Trough Plasma Concentration (Cmin) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)|||pg/mL||Standard Deviation|Mean
16758|NCT01849770|Primary|Percentage of Participants That Discontinued Study Drug|Information on adverse effects of mexiletine will be determined at each visit by direct questioning of the subjects, clinical examination, review of concomitant medications, vital signs and laboratory test results.|Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16.|||percentage of participants|||Number
16759|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 4|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
16760|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 3|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
16761|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 2|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
16762|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 1|CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||microns||Standard Deviation|Mean
16776|NCT01849419|Secondary|Cardiovascular Response to Placebo (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
16763|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 4|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||letters||Standard Deviation|Mean
16764|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 3|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||letters||Standard Deviation|Mean
16765|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 2|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.||letters||Standard Deviation|Mean
16766|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 1|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with last observation carried forward (LOCF) imputation for missing values.||letters||Standard Deviation|Mean
16767|NCT01849692|Primary|Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28|"A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline:~Greater than or equal to 4 letter gain in BCVA at Day 14~Greater than or equal to 4 letter gain in BCVA at Day 28~Greater than or equal to 80 micron decrease in CSFT at Day 14~Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis."|Baseline, Day 14, Day 28|"This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, n is the number of subjects in each arm group."||percentage of responders||90% Confidence Interval|Number
16768|NCT01849497|Secondary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|Full analysis set||percent change||Standard Error|Least Squares Mean
16769|NCT01849497|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4|Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.|Week 2 and Week 4|Full analysis set||percentage of participants||95% Confidence Interval|Number
16770|NCT01849419|Secondary|Motivation to Socialize (Placebo)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session|||units on a scale||Standard Error|Mean
16771|NCT01849419|Secondary|Motivation to Socialize (Oxytocin)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session|||units on a scale||Standard Error|Mean
16772|NCT01849419|Secondary|Motivation to Socialize (MDMA)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session|||units on a scale||Standard Error|Mean
16773|NCT01849419|Secondary|Cardiovascular Response to Placebo (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
16774|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
16775|NCT01849419|Secondary|Cardiovascular Response to MDMA (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
20611|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
16777|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
16778|NCT01849419|Secondary|Cardiovascular Response to MDMA (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||mmHg||Standard Error|Mean
16779|NCT01849419|Secondary|Cardiovascular Response to Placebo (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||bpm||Standard Error|Mean
16780|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||bpm||Standard Error|Mean
16781|NCT01849419|Secondary|Cardiovascular Response to MDMA (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session|||bpm||Standard Error|Mean
16782|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16783|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16784|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16785|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16786|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16787|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16788|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16789|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16790|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session|||units on a scale||Standard Error|Mean
16802|NCT01849068|Secondary|Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
16791|NCT01849419|Primary|Emotional Recognition (Placebo)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”~Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session|||percent intensity||Standard Error|Mean
16792|NCT01849419|Primary|Emotional Recognition (Oxytocin)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”~Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session|||percent intensity||Standard Error|Mean
16793|NCT01849419|Primary|Emotional Recognition (MDMA)|"Participants complete the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”~Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session|||percent intensity||Standard Error|Mean
16794|NCT01849289|Secondary|Number of Treatment Emergent AEs (Adverse Events)|Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)|On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)|The SAS included all subjects receiving at least one dose of investigational product.||number of events|||Number
16795|NCT01849289|Secondary|Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes|A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.|Week 26|The FAS included all randomised subjects.||participants|||Number
16796|NCT01849289|Secondary|Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)|Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.|Week 26|The FAS included all randomised subjects. Missing data were imputed using LOCF. For 2 subjects in the IDeg OD arm it was not possible to estimate CV(%) due to missing data.||percentage||Standard Deviation|Mean
16797|NCT01849289|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. LOCF values are presented for this endpoint. 7 subjects were not included in the analysis.||mmol/L||Standard Deviation|Mean
16798|NCT01849289|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).|On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)|The Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
16799|NCT01849289|Primary|Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Last Observation Carried Forward (LOCF) values were presented for this endpoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
16800|NCT01849068|Secondary|Change in Protein Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase are sufficient.|||||
16801|NCT01849068|Secondary|Change in Intestinal Protein Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of LDL receptor is sufficient.|||||
20612|NCT01763827|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
16803|NCT01849068|Primary|Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
16804|NCT01848990|Secondary|Standard Deviation of Self-Monitoring Blood Glucose Values at 6 Months|Standard deviation of self-monitoring blood glucose values was calculated based on measurements taken within 15 minutes before a meal, 1 month and up to 6 months after study drug administration. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and had evaluable self-monitoring blood glucose data.||mg/dL||Standard Error|Least Squares Mean
16805|NCT01848990|Secondary|Mean Glucose Excursions at 6 Months|A 4-hour postprandial glucose excursion was measured for 3 meals after 1 month up to 6 months. For each of the 3 meals, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal (for measurements taken within 15 minutes before a meal). The average of all excursions is presented. Least Squares (LS) means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and had evaluable mean glucose excursion data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
16806|NCT01848990|Secondary|Rates of Hyperglycemia Events|Overall rates of hyperglycemia (defined as blood glucose >240 mg/dL and >300 mg/dL) were based on measurements after 1 month up to 6 months. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and whose average bolus insulin dose was within 15 minutes before a meal.||events per participant per month|||Number
16807|NCT01848990|Secondary|Rates of Hypoglycemia Events (HE)|Overall rates of hypoglycemia (defined as blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were based on measurements after 1 month up to 6 months. A severe HE was classified as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A nocturnal HE was classified as an event with a blood glucose of ≤70 mg/dL with start time between 2300 and 0600, inclusive. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and whose average bolus insulin dose was within 15 minutes before a meal.||events per participant per month|||Number
16808|NCT01848990|Primary|Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)||Baseline, 6 Months|Participants who received at least one dose of study drug and had evaluable HbA1c data.||percentage of HbA1c||Standard Deviation|Mean
16809|NCT01848977|Primary|Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved|||%*min||Standard Deviation|Mean
16810|NCT01848977|Secondary|Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved|Before VOT. basline StO2 and SrO2 were recorded and compared each other. During VOT, minimum/maximum StO2 and SrO2 were also recorded and compared each other.|Until basline tissue oxygenation value was achieved|||percentage of oxyhemoglobin||Standard Deviation|Mean
16811|NCT01848977|Primary|Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved|||%/min||Standard Deviation|Mean
16812|NCT01848938|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)|A self-rated question that asks about the change experienced after treatment with 7 response options, ranging from “very much better” to “very much worse”.|three months|intention-to-treat analysis. Missing values at follow-up were replaced with a neutral value (i.e., no change).||participants|||Number
16813|NCT01848938|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).||episodes per week||Inter-Quartile Range|Median
16814|NCT01848938|Secondary|Patient Satisfaction|A self-rated question about if the current treatment was sufficient, with three response options|three months|||participants|||Number
16815|NCT01848938|Secondary|Usage of Incontinence Aids|Usage of incontinence aids during the last 4 weeks.|three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).||participants|||Number
16816|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.|baseline, three months|intention-to-treat analysis||units on a scale||Standard Deviation|Mean
16817|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity|baseline, three months|intention-to-treat analysis||units on a scale||Standard Deviation|Mean
16818|NCT01848899|Primary|Thrombin Generation Test: After Coronary Angiography|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|1 hour|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.||nM*minutes||Inter-Quartile Range|Median
16819|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: ADP|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.||Percent change||Inter-Quartile Range|Median
16820|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Arachidonic Acid|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.||Percent change||Inter-Quartile Range|Median
16821|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Epinephrine|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine|Baseline to 1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.||Percent change||Inter-Quartile Range|Median
16822|NCT01848899|Primary|Thrombin Generation Test: Baseline|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|baseline|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.||nM*minutes||Inter-Quartile Range|Median
16823|NCT01848847|Primary|Pain Scoring(VAS)|Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 –point visual analog scale (VAS) which means pain increases with increasing number|2 months|||units on a scale||Standard Deviation|Mean
16824|NCT01848847|Secondary|Procedure Duration|Procedural time which will be measured in minutes|two months||||||
16825|NCT01848847|Secondary|Patient Acceptability and Pain Scoring|Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.|two months||||||
16826|NCT01848847|Primary|Ease of Cervical Entry|Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.|2 months|||units on a scale||Standard Deviation|Mean
16827|NCT01848756|Secondary|Adverse Events by Severity and Relationship to Treatment|Number of patients experiencing adverse events by highest recorded severity and relationship to study tretament|Every 28 day cycle|All treated subjects||participants|||Number
16828|NCT01848756|Secondary|Ophthalmologic Changes From Baseline|Ophthalmologic assessments will be presented by cohort, study visit and dose. Number of subjects experiencing clinically relevant changes from baseline in any of these examinations will be presented using descriptive summary|Screening, end of Cycle 1, final visit|ll Treated Subjects||participants|||Number
16829|NCT01848756|Secondary|Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline|Descriptive summaries of vital signs, physical examination and clinical laboratory changes will be presented by treatment received.|Day 28 of each cycle|All Treated Subjects||participants|||Number
16830|NCT01848756|Secondary|Number of Patients With Adverse Events|Number of patients experiencing treatment emergent adverse events.|Day 28 of each cycle|All Treated Subjects||participants|||Number
16831|NCT01848756|Primary|Overall Survival|Time from start of treatment that patients remain alive.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination|||||
16832|NCT01848756|Primary|Progression Free Survival|Time on treatment with at worst stable disease.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination|||||
16833|NCT01848756|Primary|Objective Response Rate|The effect of SNX-5422 on tumor progression. Objective tumor responses (complete remissions plus partial remissions) and clinical benefit rate (complete remissions plus partial remissions plus stable disease at 6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 24 months from last patient entry|Per protocol population including all enrolled evaluable subjects.Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 6 months on study, the first analysis time point for this endpoint, at the time of study termination|||||
16834|NCT01848366|Primary|Global Response Assessment (GRA)|The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.|3 months|||units on a scale||Full Range|Mean
16835|NCT01848288|Secondary|Aspiration Time|Aspiration Time indicated the amount of time the system was aspirating during the removal of the cataractous lens. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.||seconds||Standard Error|Least Squares Mean
16836|NCT01848288|Primary|Aspiration (ASP) Fluid Used|Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.||grams||Standard Error|Least Squares Mean
41619|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban Acylglucuronide After Three Days of 5 mg IV Daily in HRS Type 2 Patients||3 days|||hr||Standard Error|Mean
16837|NCT01848288|Primary|Cumulative Dissipated Energy|Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.||percent-seconds||Standard Error|Least Squares Mean
16838|NCT01848210|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events are any unwanted medical occurrences in an individual taking part in a clinical study who is receiving a pharmaceutical product. The adverse event does not have necessarily a causal relationship with the treatment. In this definition, any adverse or unwanted signals and symptoms, or findings that appear from the start or that deteriorate during the clinical study are also included, i.e. any intercurrent diseases (recently diagnosed concomitant diseases or symptoms), accidents and clinically relevant changes in clinical laboratory values.|Baseline to Week 16|Safety Population included all randomized participants who received study drug and had a least one post-Baseline safety assessment.||participants|||Number
16839|NCT01848210|Secondary|Overall Assessment by the Investigator|The investigator recorded their impression of the overall clinical picture at the end of the treatment period (Week 16), taking into account the clinical picture compared with the Baseline visit. Data is reported for the percentage of participants in each of the following assessment categories: worsening, unchanged, discreet improvement or accentuated improvement.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.||percentage of participants|||Number
16840|NCT01848210|Secondary|Change (Reduction) From Baseline in Local Complaint Severity|"Local Complaint Severity will be assessed using the Severity Score of Local Complaints that comprises 8 items: 1=tired legs, 2=heavy legs, 3= feeling of tension, 4=feeling of swelling, 5=aching legs, 6=tingling, 7=itching, 8=burning of soles of the feet.~Each item is classified with a Likert-type scale of 5 levels, where 0=absent, 1=low, 2=medium, 3=high, 4=very high.~A total score is calculated from the sum of the scores of all the 8 items and ranges from 0 (complaints absent) to 32 (very high severity)."|Baseline and Week 16|ITT population, all participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment). Last observation carried forward (LOCF).||score on a scale||Standard Deviation|Mean
16841|NCT01848210|Primary|Mean Change (Reduction) From Baseline in Volume of Reference Leg at Week 16|Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.||milliliters (mL)||Standard Deviation|Mean
16842|NCT01848054|Secondary|Retention in Treatment in the Full Analysis Population|Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥–10% in the number of patients retained in treatment on Day 3.|Day 3|Full analysis population; patients with missing data were excluded from the analysis||participants|||Number
16843|NCT01848054|Secondary|Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase)|"Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis||units on a scale||Standard Deviation|Mean
16844|NCT01848054|Secondary|Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis||units on a scale||Standard Deviation|Mean
16845|NCT01848054|Secondary|Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable|Predose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis||units on a scale||Standard Deviation|Mean
16846|NCT01848054|Secondary|AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive|"Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||score x hour||Standard Deviation|Least Squares Mean
16847|NCT01848054|Secondary|AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed||score x hour||Standard Deviation|Least Squares Mean
16848|NCT01848054|Secondary|Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population||score x hour||Standard Deviation|Least Squares Mean
16946|NCT01846104|Secondary|Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).||Subjects with Total ELISA IgG (≥ 1:500)|||Number
16849|NCT01848054|Primary|Retention in Treatment in the Per Protocol Population|Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥–10% in the number of patients retained in treatment on Day 3.|Day 3|Per protocol population||participants|||Number
16850|NCT01847547|Secondary|Incidence Rate of Major Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16851|NCT01847547|Secondary|Incidence Rate of Major Extracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16852|NCT01847547|Secondary|Incidence Rate of Major Intracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16853|NCT01847547|Secondary|Incidence Rate of Stroke Uncertain Classification|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16854|NCT01847547|Secondary|Incidence Rate of Hemorrhagic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16855|NCT01847547|Secondary|Incidence Rate of Ischemic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16856|NCT01847547|Secondary|Incidence Rate of Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16857|NCT01847547|Secondary|Incidence Rate of Stroke or Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16858|NCT01847547|Secondary|Incidence Rate of Major Upper Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16859|NCT01847547|Secondary|Incidence Rate of Transient Ischemic Attack|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16860|NCT01847547|Secondary|Incidence Rate of Major Other Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16861|NCT01847547|Secondary|Incidence Rate of Major Urogenital Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16862|NCT01847547|Secondary|Incidence Rate of Major Lower Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16863|NCT01847547|Secondary|Incidence Rate of Pulmonary Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16864|NCT01847547|Secondary|Incidence Rate of Deep Vein Thrombosis|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16865|NCT01847547|Secondary|Incidence Rate of Venous Thromboembolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16866|NCT01847547|Secondary|Incidence Rate of Myocardial Infarction|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16867|NCT01847547|Primary|Incidence Rate of Major Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16868|NCT01847547|Primary|Incidence Rate of Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.||events per 1000 person years|||Number
16869|NCT01847443|Primary|Cmax of Nicotine 4 mg Test and Reference Product|Cmax for 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post-dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||ng/mL||Standard Deviation|Mean
16870|NCT01847443|Primary|Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product|Cmax for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||ng/mL||Standard Deviation|Mean
16871|NCT01847443|Primary|AUC(0-t) of Nicotine 4 mg Test and Reference Product|AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1of 4 treatment sequences; took atleast one dose of study medication (both test and ref) in 2 mg dose and/or in 4 mg doses; did not have any AE assimilated to vomiting in first 4h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr*ng/mL||Standard Deviation|Mean
16872|NCT01847443|Secondary|Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr*ng/mL||Standard Deviation|Mean
16873|NCT01847443|Secondary|Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||1/hr||Full Range|Median
16874|NCT01847443|Secondary|Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr||Full Range|Median
16875|NCT01847443|Secondary|Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr||Full Range|Median
16876|NCT01847443|Primary|Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product|AUC(0-t) for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.||hr*ng/mL||Standard Deviation|Mean
16877|NCT01847430|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|Serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Month 1)|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
16878|NCT01847430|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
18569|NCT01807624|Primary|AUC0-t of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||ng.h/mL||Standard Deviation|Mean
16879|NCT01847430|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
16880|NCT01847430|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50 mm.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.||Participants|||Number
16881|NCT01847430|Secondary|Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.|"Anamnestic response to the challenge dose was defined as:~At least (i.e. greater than or equal to ) 4-fold rise in post-vaccination anti-HBs antibody concentrations in subjects seropositive at the pre-vaccination time point Post-vaccination anti-HB antibody concentrations ≥10 mIU/mL in subjects seronegative at the pre-vaccination time point"|Prior to vaccination with the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||Participants|||Number
16882|NCT01847430|Secondary|Antibody Titers Against Hepatitis B Virus|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% CIs.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||mIU/mL||95% Confidence Interval|Geometric Mean
16883|NCT01847430|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off values defined were ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.|Before (Day 0) and one month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||Participants|||Number
16884|NCT01847430|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.||Participants|||Number
16885|NCT01847196|Secondary|Device Performance||From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days|||device malfunctions|||Number
16886|NCT01847196|Primary|Number of Adverse Events Occuring for All Evaluable Subjects|All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.|From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days|||participants|||Number
16887|NCT01847131|Secondary|The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline|Rhinitis medicamentosa is the rebound nasal congestion after prolonged use (>7 days) of topical nasal decongestant (eg. oxymetazoline). However, a previous study by Baroody FM et al (J Allergy Clin Immunol 2011;127:927-34) showed that using oxymetazoline together with intranasal steroid for 1 month did not increase rhinitis medicamentosa compared to placebo. So we give rhinitis patients in the treatment group with oxymetazoline and intranasal steroid for 1 month, then stop using oxymetazoline and come back for the last visit 2 weeks later to see which patients develop rebound nasal congestion (rhinitis medicamentosa).|6 weeks|||participants|||Number
16888|NCT01847131|Primary|Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction|Primary outcome measure is the nasal congestion score measuring by visual analog scale (VAS) ranging from 1-10 (0 = no symptom and 10 = the most severe symptom) compared between treatment group and controlled group.|6 weeks|||units on a scale||95% Confidence Interval|Geometric Mean
16889|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of phone calls to physicians.|Up to 18 Month Visit-End of Study|ITT Population||Phone Calls||Full Range|Median
16890|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of hours per week caregivers spent caring for patients.|Up to 18 Month Visit-End of Study|ITT Population||Hours Per Week||Full Range|Median
16891|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of days per week of missed work because of health reasons.|Up to 18 Month Visit-End of Study|ITT Population||Days Per Week||Full Range|Median
16892|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of nights spent at the hospital.|Up to 18 Month Visit-End of Study|ITT Population||Nights||Full Range|Median
18570|NCT01807624|Primary|Half-life of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||minutes||Standard Deviation|Mean
16893|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of unplanned inpatient hospitalizations, emergency room visits, outpatient hospitalizations, physician office visits.|Up to 18 Month Visit-End of Study|ITT Population||Visits||Full Range|Median
16894|NCT01846741|Secondary|Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from “Extremely Difficult” (5) to “Extremely Easy” (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery, the first day of EMU, the end of EMU, and the 6 month follow-up visit.~Overall Usability was calculated as percentage of the users who found the overall usability of system to be easy-2 or extremely easy-1."|Up to 6 Month Visit|ITT Population||Percentage of Participants Rated 1 or 2|||Number
16895|NCT01846741|Secondary|Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System|All adverse events (AEs) occurring during the study were collected and incidence rates tabulated by System Organ Class and Preferred Term utilizing MedDRA version 16.1 dictionary. The incidence profile was used to assess differences in near term tolerability rates relative to standard VNS Therapy.|From initial titration visit (approximately 2 weeks after implantation) up to End of Study|ITT Population||Number of Participants|||Number
16896|NCT01846741|Primary|Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration.|The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary.|Up to 18 Month Visit-End of Study||||||
16897|NCT01846741|Secondary|Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline|"AED load were collected and measured from baseline.The AED load is calculated as the sum of all ratios of the total daily dose of each medication taken on the day of the visit over the defined daily dose of the medication for the main indication according to the WHO database.~Positive median value indicates increased drug load."|Up to 18 Month Visit-End of Study|ITT Population||Percent Change||Full Range|Median
16898|NCT01846741|Secondary|Assess Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6,12 and 18 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the proportion of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 18 Month Visit-End of Study|ITT Population||Percentage of Participants||95% Confidence Interval|Number
16899|NCT01846741|Secondary|Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)|"Adult subjects (18 years and older) completed the Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-P) survey questionnaire at screening and safety follow-up visits. The range for QOLIE-31-P (Sub-domains) scale is 0-100. The higher the score the better quality of life.~Mean QOLIE-31-P scores at 3, 6, 12 and 18 months were compared to baseline. MIC Thresholds as defined in Simon Borghs, Christine de la Loge, Joyce A. Cramer, defining minimally important change in QOLIE-31-P scores."|Up to 18 Month Visit-End of Study|ITT Population||Units on a Scale||Standard Deviation|Mean
16900|NCT01846741|Secondary|Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.~Mean SSQ scores at 3, 6, 12 and 18 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire."|Up to 18 Month Visit-End of Study|ITT Population||Units on a Scale||Standard Deviation|Mean
16901|NCT01846741|Secondary|Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.~Negative median value means improvement."|Up to 18 Month Visit-End of Study|ITT Population||units on a scale||Full Range|Median
16902|NCT01846741|Secondary|Assess Characterization of Seizures (Duration and Cessation)|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population||Percent of Seizures Ended During Stim|Participants||Number
16903|NCT01846741|Secondary|Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods|"Each day in the EMU, subjects exercised for up to 3 minutes stepping up and down at a submaximal effort level on a step stool. Subject's resting heart rate was compared with the calculated 85% of the patient’s age-predicted maximum heart rate. This calculated heart rate was then used as termination criteria for the step test.~Non-Seizure Detection Rate (previously known as Potential False Positive Rate) is defined as the total number of non-seizure detections summed for the group divided by the total evaluable monitoring time during the EMU. The non-seizure detection rate per hour was calculated at the various tachycardia detection settings for all subjects during EMU and during exercise activities (stair stepper)."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population. 5 participants analyzed for >=70%, 4 for >=60% setting, 8 for >=50% setting, 2 for >=40% setting, 1 for the >=30% setting.||detections per hour||95% Confidence Interval|Number
16947|NCT01846104|Primary|Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.||Six months|All statistical analysis of safety data was conducted using 4 subjects at every time point except Day 180 (for which there were 3 subjects).||participants|||Number
16904|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.||Percent of True Positive Seizures||95% Confidence Interval|Number
16905|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define electrographic seizure onset times. Seizure onset times were then compared with observed M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. Threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). No subjects were assigned to settings 3 and 6 that had seizures with a corresponding heart rate increase of >= 50% and >= 20%, respectively. Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.||Percent of True Positive Seizures||95% Confidence Interval|Number
16906|NCT01846741|Secondary|Summary of Seizures Reported by Investigators and Triple Review|"Seizure events were recorded during the EMU stay (only Automatic Stimulation Mode aka AutoStim ON) using vEEG and ECG to evaluate tachycardia detection algorithm performance. The threshold for the AutoStim feature (20-70%) was programmed for each subject, based upon the historical ictal elevation in heart rate for that subject, requiring the corresponding heart rate elevation above that of a moving baseline window.~Number of seizures observed and reported by investigators during the EMU stay (several subjects had more than one type of seizure) were collected and also reviewed by three (3) independent and blinded reviewers for confirmation. Additionally, the reviewers identified new seizures while reviewing the study EMU stay vEEG."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population: Consists of all patients in the safety population who have any EMU performance recorded data and experienced any seizures.||Number of Seizures|||Number
16907|NCT01846455|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone|Apparent volume of distribution during terminal phase (only for buprenorphine and naloxone), calculated as Dose/(λz • AUC0-inf).|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||Liters||Geometric Coefficient of Variation|Geometric Mean
16908|NCT01846455|Primary|Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone|Apparent body clearance (only for buprenorphine and naloxone), calculated as Dose/AUC0-inf.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||L/hr||Geometric Coefficient of Variation|Geometric Mean
16909|NCT01846455|Primary|Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|Terminal elimination half-life, calculated as ln(2)/λz. The terminal phase elimination half-life was calculated over a period of at least 2 half-lives.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||hours||Geometric Coefficient of Variation|Geometric Mean
16910|NCT01846455|Primary|Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|For the determination of λz, only those data points judged to describe the terminal log-linear decline resulting in an adjusted coefficient of determination value (R2) > 0.7 were used in the regression. A minimum of 3 data points were used in calculating λz.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||1/hour||Geometric Coefficient of Variation|Geometric Mean
16911|NCT01846455|Primary|Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"Calculated as:~(AUC0-inf - AUC0-last)/AUC0-inf * 100~AUC0-inf, apparent body clearance (CL/F), and apparent volume of distribution during terminal phase (Vz/F) would not have been reported if %AUCextrap was > 20%."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||percentage of AUC0-inf||Standard Deviation|Mean
16912|NCT01846455|Primary|Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||hours||Full Range|Median
16913|NCT01846455|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||hours||Full Range|Median
16914|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"The extrapolation to infinity was done using the terminal phase.~AUC0-inf = AUC0-last + Ct/λz~Where Ct was the last observed quantifiable concentration and λz was the apparent terminal phase elimination rate constant."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
16915|NCT01846455|Primary|Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
16916|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis:~AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
16917|NCT01846416|Secondary|Minimum Plasma Concentration (Cmin) for Atezolizumab||Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16|Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
16918|NCT01846416|Secondary|Maximum Plasma Concentration (Cmax) for Atezolizumab||Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1|"Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points.~Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort."||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
16919|NCT01846416|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.||months||95% Confidence Interval|Median
16920|NCT01846416|Secondary|Percentage of Participants With Death|Participants were followed for survival throughout the study.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.||percentage of participants|||Number
16921|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6 and Month 12 According to Modified RECIST|Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Months 6 and 12|Efficacy-evaluable population.||percentage of participants|||Number
16922|NCT01846416|Secondary|PFS According to Modified RECIST|PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||months||95% Confidence Interval|Median
16948|NCT01846039|Secondary|Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others||Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
16923|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to Modified RECIST|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||percentage of participants|||Number
16924|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6 and Month 12 According to RECIST v1.1|Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Months 6 and 12|Efficacy-evaluable population.||percentage of participants|||Number
16925|NCT01846416|Secondary|Progression-Free Survival (PFS) According to RECIST v1.1|PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||months||95% Confidence Interval|Median
16926|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to RECIST v1.1|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.||percentage of participants|||Number
16927|NCT01846416|Secondary|Percentage of Participants With 6-Month Duration of Objective Response|Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.|Month 6|Efficacy-evaluable population with a confirmed objective response.||percentage of participants|||Number
16928|NCT01846416|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population with a confirmed objective response.||months||95% Confidence Interval|Median
16929|NCT01846416|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)|Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population.||percentage of participants||95% Confidence Interval|Number
16930|NCT01846416|Primary|Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs, and all new measurable lesions to baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study.||percentage of participants||95% Confidence Interval|Number
16931|NCT01846299|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|12 months|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.||Number of primary reasons|Participants||Number
16932|NCT01846299|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to Month 12, the maximum number of retreatments was 5.|Month 6, month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.||Participants|||Number
16933|NCT01846299|Secondary|Number of Participants With Ranibizumab Treatments|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.||Participants|||Number
16934|NCT01846299|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||Participants|||Number
16935|NCT01846299|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6 , Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||Participants|||Number
16936|NCT01846299|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline (BL), month 1 through month 6, month 1 through month 12|The FAS was used for this analysis. The FAS included randomized participants who received at least one dose of study medication.||letters||Standard Deviation|Mean
16937|NCT01846299|Secondary|Number of Participants Requiring Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The FAS was used for this analysis. The FAS included all randomized participants who received at least one dose of study treatment.||Participants|||Number
16938|NCT01846299|Secondary|Number of Participants With Presence of Active Macular Edema (ME) Leakage|The presence of active ME leakage was assessed by fluorescein angiography (FA).|Month 2|The FAS was used this analysis. The FAS included randomized participants who received at least one dose of study treatment.||Participants|||Number
16939|NCT01846299|Secondary|Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline|The presence of subretinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
16940|NCT01846299|Secondary|Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
16941|NCT01846299|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||microliters (ul)||Standard Deviation|Mean
16942|NCT01846299|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||micrometers (um)||Standard Deviation|Mean
16943|NCT01846299|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.||letters||Standard Error|Least Squares Mean
16944|NCT01846299|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 2|Full analysis set: The full analysis set included all randomized participants who received at least one dose of study treatment.||letters||Standard Error|Least Squares Mean
16945|NCT01846104|Secondary|Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).||participants|||Number
16949|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)|Participants assessed their satisfaction with the study drug (VOLUMA) treatment at Days 113, 239 and 421 using the TSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants satisfied or very satisfied with study drug treatment is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
16950|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)|Participants assessed their satisfaction with the appearance of their nose at Days 113, 239 and 421 using the NSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants who rated themselves as satisfied or very satisfied is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
16951|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
16952|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician|The independent central evaluating physician evaluated the improvement of the participant’s nose compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
16953|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
16954|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113|The independent central evaluating physician evaluated the improvement of the participant’s nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.||percentage of participants|||Number
16955|NCT01845155|Secondary|Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)||the average time period was 3 months|||Hz||Standard Deviation|Median
16956|NCT01845155|Primary|Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment|Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.|average time period was 3 months|||absolute TF-score change||Standard Deviation|Mean
16957|NCT01845103|Secondary|Major Adverse Coronary and Cerebrovascular Events (MACCE)|"MACCE includes:~Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF"|30 day|||percentage of participants|||Number
16958|NCT01845103|Primary|Mortality||30 day|||percentage of participants|||Number
16959|NCT01845077|Primary|Cmax of Metformin|Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
16960|NCT01845077|Primary|AUC0-tz of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
16961|NCT01845077|Secondary|AUC0-infinity of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
16999|NCT01844479|Secondary|Gait Speed Variability Single Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Single task means walking without a simultaneous mental task.|both footwear conditions up to 30 minutes|||percentage of gait||Standard Deviation|Mean
16962|NCT01845077|Secondary|AUC0-infinity of Linagliptin|Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
16963|NCT01845077|Primary|Cmax of Linagliptin|Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
16964|NCT01845077|Primary|AUC0-72 of Linagliptin|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
16965|NCT01844895|Secondary|Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.|Serum samples for immunogenicity were evaluated for presence of anti-abatacept antibodies using a validated bridging ECL on Day 29 and Day 113. The ECL assay differentiated between 2 antibody specificities: the immunoglobulin (Ig) G and/or junction region and cytotoxic leukocyte antigen 4 (CTLA4) and possibly Ig. A positive immunogenicity response relative to baseline was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value.|Days 29 and 113|A subset of the treated analysis population for whom at least 1 immunogenicity sample was collected and assessed for serum anti-abatacept antibodies, were summarized.||participants|||Number
16966|NCT01844895|Secondary|Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken at 0 hour (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy. Blood samples for PK were taken at 0 hour (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL).|Days 22, 29, 57, 85, 106, and 113|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector and with Cmin obtained appropriately (7 days + or -3 days after the previous dose).||μg/mL||Geometric Coefficient of Variation|Geometric Mean
16967|NCT01844895|Secondary|Geometric Mean of Area Under Serum Concentration-time (AUC) During a Dosing Interval (TAU) of Abatacept During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 106 at 0 h (predose), Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) where TAU = 168 hours was calculated in µg*h/mL|Days 22, 24, 25, 26,29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
16975|NCT01844778|Secondary|Minimum Inhibitory Concentration (MIC) - MIC50 and MIC90 Tobramycin Values|MIC50/90 is the lowest concentration required to inhibit 50%/90% of the isolates tested. The MIC50/90 of a range of antibiotics for P.aeruginosa was determined at the start and end of each treatment cycle, and at the end of the off-treatment period of the second cycle.|days 1, 28, 57, 84, 112|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day. The number of isolates tested = m.||ug/mL|||Number
17000|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Dual Task|Mediolateral (side-to-side) center of mass displacement in deg2 (degrees squared) under dual task gait. Dual task used a simultaneous mental task while walking.|both footwear conditions up to 30 minutes|||deg2||Standard Deviation|Mean
16968|NCT01844895|Secondary|PK Analysis: Median Time to Achieve Cmax (Tmax) During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Tmax was measured in hours (h).|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110,113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.||h||Full Range|Median
16969|NCT01844895|Secondary|PK Analysis: Geometric Mean of Maximum Observed Serum Concentration (Cmax) of Abatacept During the Sampling Period Between Substudy Days 22 and 29 for the Prefilled Syringe and Between Substudy Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Cmax was measured in μg/mL.|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
16970|NCT01844895|Primary|Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113)|Abatacept SC was self-administered with a prefilled syringe every 7 days for the first 4 weeks until Day 29; Blood samples for PK were taken pre-dose (0 hour) on Days 29 and 113. Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL). Adjusted geometric mean and 90% confidence interval (CI) are presented.|Day 29, Day 113|The primary PK analysis population is a subset of the Treated Analysis population with (1) viable Cmin data on both substudy Days 29 and 113 (2) no missed Abatacept dose during the substudy period.||μg/mL||90% Confidence Interval|Geometric Mean
16971|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who had no major protocol deviations (CE population).||participants|||Number
16972|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who received at least 1 dose of study drug (MITT population).||participants|||Number
16973|NCT01844856|Primary|Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after the first dose of study drug|All randomized participants who had baseline bacterial pathogens that cause cIAI and against at least one of which the investigational drug has in vitro antibacterial activity (micro-ITT population).||participants|||Number
16974|NCT01844778|Secondary|Number of Participants With Post-inhalation Bronchospasm|Bronchospasm was defined as the relative decrease of 20% or more in forced expiratory volume in 1 second (FEV1) percent predicted from pre-dose to 15 to 45 minutes post-dose.|days 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day.||Participants|||Number
16976|NCT01844778|Secondary|Number of Participants With Any Contaminated Delivery Device|Devices used to administer the drugs (the T-326 inhaler and nebulisers) were swabbed for contamination testing at the start and end of each treatment cycle (or discontinuation visit if the participant withdrew). No assessments were required from the T-326 inhaler when participants started the treatment period (days 1 and 57). Microbial contamination was measured according to device type and the frequency of organism growth (light/ moderate/ heavy). All nebulisers (neb) used by the participants were analyzed, including those for inhaling other medications, like mucolytics.|days (d) 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with an available culture from the delivery device, were analyzed.||Participants|||Number
16977|NCT01844778|Secondary|Change in P. Aeruginosa Sputum Density|Sputum samples were sent to a central laboratory at the start and end of 2 treatment periods. The absolute change in the number of colony forming units (CFU) of Pseudomonas aeruginosa in sputum = the value of end of on/off treatment period of the cycle minus the pre-dose value at the start of that cycle. A negative change from baseline indicates improvement.|days 1, 28 (cycle 1); 57, 84, 112 (cycle 2)|"The FAS was considered and included participants who received at least 1 dose of treatment. Only participants (n), with values at the start and end of an on-treatment period (on-treatment change), and/or with values at the start of an on-treatment period and end of an off-treatment period (off-treatment change), were analyzed."||log10 CFU/mL||Standard Deviation|Mean
16978|NCT01844778|Primary|Mean Total Administration Time|The mean total time for administration of TIP via T-326 inhaler versus the total time for administration of COLI or TIS was assessed from information entered by participants into an ediary during the last 7 days prior to the last dose of a cycle. The total time included the setup, preparation, administration and cleaning/disinfection time.|days 22 through 28 (cycle 1), days 78 through 84 (cycle 2)|The full analysis set (FAS) was considered for this analysis. The FAS included participants who received at least 1 dose of treatment. Only participants (n), with non-missing mean total administration time of initial and second cycles, were analyzed.||minutes||Standard Deviation|Mean
16979|NCT01844700|Secondary|BMI Percentile||baseline to week 12|||BMI percentile||Standard Deviation|Mean
16980|NCT01844700|Secondary|BMI Z-scores||baseline to week 12|||BMI z-score||Standard Deviation|Mean
16981|NCT01844700|Secondary|Percent Weight Change Compared to Baseline Weight||baseline to week 12|||percentage of weight change||Standard Deviation|Mean
16982|NCT01844700|Primary|Weight Change||baseline to week 12|||lbs||Standard Deviation|Mean
16983|NCT01844531|Secondary|AUC0-tz for Metformin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
16984|NCT01844531|Primary|Cmax for Metformin|Cmax (maximum measured concentration of the analyte in plasma) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||ng/mL||Geometric Coefficient of Variation|Geometric Mean
16985|NCT01844531|Primary|Cmax for Empagliflozin|Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||nmol/L||Geometric Coefficient of Variation|Geometric Mean
16986|NCT01844531|Secondary|AUC0-tz for Empagliflozin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
16987|NCT01844531|Primary|AUC0−∞ for Metformin|AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
16988|NCT01844531|Primary|AUC0−∞ for Empagliflozin|AUC0−∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
17023|NCT01843920|Secondary|Return of Intraocular Pressure to Normal Levels|The normal intraocular pressure range is 10-21 mm Hg|Post-op Day 1, Week 1, Month 1, Month 2, Month 4||||||
16989|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Cumulative Period|Overall number of participants with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the ST or LTE period, elected not to enter the LTE period, or completed both ST and LTE periods.|Day 1 to 6 months following discontinuation of treatment, up to March 2015|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication||participants|||Number
16990|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Short Term Period|Overall number of participants with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the ST period or completed the ST study without continuing abatacept treatment.|Day 1 to 168 days after the last dose of study medication in the short-term period|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication||participants|||Number
16991|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.~The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose, up to March 2015|All treated participants, ages 6 to 17||participants|||Number
16992|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17||participants|||Number
16993|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.~The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17||participants|||Number
16994|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17||participants|||Number
16995|NCT01844518|Secondary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113 during a 4-month treatment period. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL).|Days 57, 85 and 113|All treated participants, ages 6 to 17, with PK-evaluable concentration data||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
16996|NCT01844518|Secondary|Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)|ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables [number of active joints, number of joints with limitation of motion (LOM), physician global assessment of disease activity, parent global assessment of patient overall well-being, functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ) and C-reactive protein (CRP)] and ≥30% worsening in not more than 1 of the remaining 6 JIA core set variables.|Day 113|All participants, ages 6 to 17||percentage of participants||95% Confidence Interval|Number
16997|NCT01844518|Primary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL.|Day 113|All treated participants, ages 6 to 17, with evaluable PK concentration data||µg/mL||Geometric Coefficient of Variation|Geometric Mean
16998|NCT01844479|Secondary|Gait Speed Variability Dual Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Dual task used a simultaneous mental task while walking.|Both footwear conditions up to thirty minutes|||percentage of gait||Standard Deviation|Mean
17001|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Single Task|Mediolateral (side-to-side) center of mass displacement with displacement in deg2 (degrees squared) under single task gait conditions. Single task means walking without a simultaneous mental task.|under each foot where condition up to 30 minutes|||deg2||Standard Deviation|Mean
17002|NCT01844479|Secondary|Double Support Time Dual Task Gait Initiation|percentage of stride time spent in double support time during dual task conditions and during gait initiation. Double support time refers to the time spent with both feet on the ground. Dual task used a simultaneous mental task while walking.|during each foot where condition up to 30 minutes|||percentage of stride time||Standard Deviation|Mean
17003|NCT01844479|Secondary|Double Support Time Single Task|percentage of stride time spent in double support time during gait initiation. Double support time refers to the time spent with both feet on the ground. Single task means walking without a simultaneous mental task.|during each foot where condition up to 30 minutes|||percentage of stride time||Standard Deviation|Mean
17004|NCT01844479|Secondary|Stride Velocity - Dual Task|Stride velocity during steady state dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes|||m/s||Standard Deviation|Mean
17005|NCT01844479|Secondary|Gait Initiation - Dual Task|The number of steps taken to reach steady state walking under dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes|||Number of steps||Standard Deviation|Mean
17006|NCT01844479|Other Pre-specified|Sudomotor Function|Sudomotor function will be measured by electrical sweat conductance (ESC), as expressed in microSiemens (µS).|at baseline, this is a single visit study expected to last one hour|||µS||Standard Deviation|Mean
17007|NCT01844479|Other Pre-specified|Stride Velocity - Single Task|Stride velocity steady state gait single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes|||meters/second||Standard Deviation|Mean
17008|NCT01844479|Secondary|Gait Initation - Single Task|The number of steps taken to reach steady state walking under single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes|||Number of steps||Standard Deviation|Mean
17009|NCT01844479|Primary|Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking|Plantar foot temperature changes in regions-of-interest in response to walking 200 steps will be measured in each footwear condition and compared to baseline.|baseline and after 200 steps in each condition, this is a single visit study expected to last one hour|||Absolute change in temperature degrees||Standard Deviation|Mean
17010|NCT01844388|Other Pre-specified|Reason for Contact Lens Replacement|The reason the contact lens needed to be replaced was recorded for each eye. The following categories are reported: Scheduled Replacement, Discomfort, Lens Damage, Unacceptable Vision and Lens Lost. There may be multiple reasons for replacement of the contact lens for a single eye.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.||eyes|Participants||Number
17011|NCT01844388|Other Pre-specified|Average Daily Contact Wearing Time|The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.||hours per day||Standard Deviation|Mean
17012|NCT01844388|Primary|Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline|Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.|Baseline, Day 90|Intent-to-treat Population included all randomized participants.||percentage of participants|||Number
17013|NCT01844206|Primary|The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery|The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.|Up to 48 hours post-operatively|"Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero (0) for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank."|||||
17014|NCT01843972|Primary|Frequency of Subjects With Drug-related Adverse Events (Part I)|Frequency of subjects with drug-related Adverse Events (AEs) (Part I)|Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7|Treated Set (TS): all subjects who were documented to have taken at least 1 dose of study medication.||Participants|||Number
17015|NCT01843972|Secondary|Tmax (Part I)|"tmax (time from dosing to maximum measured concentration of BI 691751) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PKS||h||Full Range|Median
17024|NCT01843920|Primary|Complete Resolution of Intraocular Gas Bubble|This will be reported by the patient when they see/feel the gas bubble disappear.|Following surgery, until gas bubble is gone. Up to 2 months.|||Duration in days, gas bubble||Full Range|Mean
17038|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 0.5|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17976|NCT01819194|Primary|Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale|Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 – 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.|Post 3 days of wear|Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.||eyes|Participants||Number
17016|NCT01843972|Secondary|t1/2 (Part I)|"t1/2 (terminal half-life of the analyte of BI 691751 in plasma) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Pharmacokinetic (PK) set (PKS) which includes all subjects of the treated set were were randomised to active treatment in the single rising dose part of bioavailability part, and had no important protocol violations relevant for the statistical evaluation of further PK parameters. Only subjects with calculable PK parameter were analysed.||h||Geometric Coefficient of Variation|Geometric Mean
17017|NCT01843972|Secondary|AUC0-tz|"AUC0-tz (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 up to the last quantifiable data point) (Part I and Part II)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h|PPS-DP for part I and PPS-BA for part II. Only subjects with calculable PK parameter were analysed.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
17018|NCT01843972|Secondary|AUC0-infinity (Part I)|"AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 extrapolated to infinity) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PPS-DP. Only subjects with calculable PK parameter were analysed.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
17019|NCT01843972|Secondary|Cmax (Part I)|"Cmax (maximum measured concentration of BI 691751 in plasma) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Per protocol set for evaluation of dose proportionality (PPS-DP): This subject set includes all subjects of the TS who were randomised to active treatment in the single rising dose part or BA part, and had no important PVs relevant for the statistical evaluation of dose proportionality. Only subjects with calculable PK parameter were analysed.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
17020|NCT01843972|Primary|Cmax (Part II)|Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration|PPS-BA. Only subjects with calculable PK parameter were analysed.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
17021|NCT01843972|Primary|AUC0-72h (Part II)|"AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II).~PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration|Per protocol set for evaluation of bioavailability (PPS-BA). Only subjects with calculable PK parameter were analysed.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
17022|NCT01843933|Primary|Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions|"Mild Events/Interventions:~Mild oxygen desaturation: Pulse oximetry < 93% on room air or <95% on oxygen~Hypopneic hypoventilation: ETCO2 values < 30mmHg for >30 seconds~Bradypneic hypoventilation: ETCO2 values > 50mmHg for >30 seconds~Stimulation: Verbally or physical stimulation to encourage breathing~Moderate Events/Interventions:~Moderate oxygen desaturation: Pulse oximetry < 85% on room air or <90% on oxygen~Apnea: ETCO2 value of 0mmHg or respiratory rate of 0 for >20 seconds~Airway obstruction: ETCO2 value of 0mmHg without cessation of respiratory effort~Airway repositioning: Jaw thrust or chin lift or use of a shoulder roll~Airway adjunct: Oral or nasal airway device~Severe Events/Interventions:~Severe oxygen desaturation: Pulse oximetry < 80% on room air or <85% on oxygen~Assisted ventilation: Use of a bag-valve mask, a laryngeal mask airway or endotracheal intubation~Reversal medications: Use of naloxone or flumazenil"|Post operative period (From entering the PACU until discharge. Average time is 1 hour)|||participants|||Number
17025|NCT01843777|Secondary|Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids|The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points.|Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention|In the standard-of-care group, one subject withdrew from the study prior to the collection of outcome measures. In the treatment group, one subject did not answer one of the questions on the baseline questionnaire, thereby preventing calculation of a total score. This subject's data is therefore not included in the analysis.||units on a scale||Standard Deviation|Mean
17026|NCT01843777|Primary|Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention|Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.|Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date|"Standard-of-care group: one subject withdrew prior to the collection of outcome measures and one subject did not give valid data log measurement. These subjects are not included.~Treatment: Three subjects did not give valid outcome data log measurement and one did not give a valid baseline measure. These subjects are not included."||hours||Standard Deviation|Mean
17027|NCT01843673|Primary|Greater Than or Equal to 5% Variation of Normal Tissue Toxicity||Up to 7 weeks|No data analyzed due to staff leaving primary institution.|||||
17028|NCT01843673|Primary|Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%||Up to 7 weeks|No data analyzed due to staff leaving primary institution.|||||
17029|NCT01843673|Primary|Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies|The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.|up to 7 weeks|Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.||mm||Standard Deviation|Mean
17030|NCT01843660|Secondary|Number of Participants With Overall Analgesic Satisfaction Score|Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17031|NCT01843660|Secondary|Number of Participants With Analgesic Satisfaction Score|Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17032|NCT01843660|Secondary|Number of Participants Who Required Additional Dosage Administration|Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.|Baseline up to Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17033|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 6|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17034|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 4|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17035|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 3|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17036|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 2|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17037|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 1|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Participants|||Number
17039|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
17040|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
17041|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
17042|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
17043|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
17044|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.||Units on a scale||Standard Deviation|Mean
17045|NCT01843465|Primary|Real-time Documentation of Pulmonary Vein Disconnection|"Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as yes or no, and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4."|atrial fibrillation cryoablation procedure|According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed.||number of PVs disconnected in realtime|Participants||Number
17046|NCT01843192|Secondary|Number of Subjects With 1 Chest Tube Placed|All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants|||Number
17047|NCT01843192|Secondary|Occurrence of Intra-operative Leak Test|This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure. This analysis was further restricted to those subjects in whom an intra-operative leak test was actually performed, as it was not standard of care at all participating institutions.||participants|||Number
17048|NCT01843192|Secondary|Operative Time|Defined as the duration in hours from the first skin incision to the closure of the last incision|Day of surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||hours||Standard Deviation|Mean
17049|NCT01843192|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||days||Standard Deviation|Mean
17050|NCT01843192|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||milliliters||Standard Deviation|Mean
17051|NCT01843192|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||days||Standard Deviation|Mean
17052|NCT01843192|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
17067|NCT01842841|Primary|Number of Participants With Abnormal and Clinically Significant Laboratory Test Results|Laboratory test results were considered abnormal and clinically significant at the discretion of the investigator.|From Week 65 until the end of study (Week 155)|Safety population.||participants|||Number
17068|NCT01842841|Primary|Number of Participants Using Concomitant Medication||From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.||participants|||Number
17053|NCT01843192|Primary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure||percentage of participants||95% Confidence Interval|Number
17054|NCT01842841|Secondary|Change From Baseline in Chemokine [C-C Motif] Ligand 18 (CCL18) Levels at Week 101|Plasma CCL18 concentrations were measured using a time-resolved fluorescence assay. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
17055|NCT01842841|Secondary|Number of Participants With Change From Baseline in Neurological Status at Week 103|Neurological status was considered normal or abnormal based on investigator’s discretion. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population. Number of participants analyzed signifies participants evaluable for this outcome.||participants|||Number
17056|NCT01842841|Secondary|Change From Baseline in Plasma Chitotriosidase Levels at Week 101|Plasma chitotriosidase activity levels were measured using an enzymatic assay with 4-methylumbelliferyl-deoxychitobiose as a substrate. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population. Number of participants analyzed signifies participants who were not deficient at baseline in chitotriosidase activity or who did not have a 24 base pair duplication in either copy of the chitotriosidase gene.||nanomole/milliliter/hour (nmol/mL/h)||Standard Deviation|Mean
17057|NCT01842841|Secondary|Change From Baseline in Skeletal Age at Week 103: Z-Score|Skeletal age was measured via radiography (X-ray) of the left hand and wrist by the method of Greulich and Pyle. The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there was <50% of participants had evaluable data.|||||
17058|NCT01842841|Secondary|Change From Baseline in Growth Velocity at Week 101 : Height Z-Score|The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. World Health Organization 2007 growth reference data were used for Z-score calculation. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Data was not reported as there was <50% of participants had evaluable data.|||||
17059|NCT01842841|Secondary|Change From Baseline in Bone Marrow Burden (BMB) Score at Week 103|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0-16 points. A higher BMB score signified more severe bone marrow involvement. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population.||units on a scale||Standard Deviation|Mean
17060|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: T-Score|BMD was measured by DXA for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized T-scores; normal values were used from databases from Hologic based on standard criteria. T-scores are the number of SDs above or below the average for a young adult at peak BMD. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were <50% of participants with evaluable data.|||||
17061|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: Z Score|BMD was measured by dual energy x-ray absorptiometry (DXA) for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized Z-scores (matched for age and gender). Z-scores express the BMD as the number of standard deviations (SDs) above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if greater than (>) 50 percent (%) of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were lesser than (<) 50% of participants with evaluable data.|||||
17062|NCT01842841|Secondary|Change From Baseline in Spleen Volume Normalized to Body Weight at Week 103|Spleen volume was measured using MRI. Spleen volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population||Percentage of body weight||Standard Deviation|Mean
17063|NCT01842841|Secondary|Change From Baseline in Liver Volume Normalized to Body Weight at Week 103|Liver volume was measured using magnetic resonance imaging (MRI). Liver volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population||Percentage of body weight||Standard Deviation|Mean
17064|NCT01842841|Secondary|Change From Baseline in Platelet Count at Week 101|Baseline was the modified baseline platelet count, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population||*10^9 platelets per liter||Standard Deviation|Mean
17065|NCT01842841|Secondary|Change From Baseline in Hemoglobin Concentration at Week 101|Baseline was the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population||gram per deciliter (g/dL)||Standard Deviation|Mean
17066|NCT01842841|Primary|Number of Participants With Positive Anti-Velaglucerase Alfa Antibodies|Serum samples were collected for all participants for determination of anti-velaglucerase alfa antibodies every 12 weeks.|From Week 65 until the end of study (Week 155)|Safety population.||participants|||Number
17069|NCT01842841|Primary|Number of Participants With Drug-related Adverse Events (AEs), Infusion-related AEs, and Serious AEs (SAEs)|An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered related to investigational product. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An infusion-related AE was defined as an AE that started either during or within 12 hours after the start of the infusion and that was judged as possibly or probably related to investigational product.|From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.||participants|||Number
17070|NCT01842607|Secondary|Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline|Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).||Participants|||Number
17071|NCT01842607|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline|Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).||Participants|||Number
17072|NCT01842607|Secondary|Change From Baseline in Pulse Rate Assessed at Week 52|Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Beats per minute (BPM)||Standard Deviation|Mean
17073|NCT01842607|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Millimeter of mercury (mmHg)||Standard Deviation|Mean
17074|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||participants|||Number
17075|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
17097|NCT01841970|Secondary|Incidence of Recurrence of Pre-procedure Symptoms|Recurrence of pre-procedure symptoms after initial improvement|Post treatment at Month 1, Month 3, and Month 6|||participants|||Number
17076|NCT01842607|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Milliseconds (msec)||Standard Deviation|Mean
17077|NCT01842607|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, only participants with ECG results post-baseline were analyzed||Participants|||Number
17078|NCT01842607|Secondary|Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions|Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population||Participants|||Number
17079|NCT01842607|Secondary|Number of Participants Hospitalized Due to Exacerbations and Adverse Events|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population||Participants|||Number
17080|NCT01842607|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population.||Participants|||Number
17081|NCT01842607|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline and up to Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Milliliters (mL)||Standard Deviation|Mean
17082|NCT01842607|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Score on scale||Standard Deviation|Mean
17083|NCT01842607|Secondary|Annualized Rate of Exacerbations Per Year|Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose|AT Population||Exacerbations per year||95% Confidence Interval|Mean
17098|NCT01841970|Primary|Number of Participants With Resolution of Symptoms|The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment|Post treatment at Month1, Month 3, Month 6|18 participants included. 2 participants were lost to follow up.||participants|||Number
20895|NCT01757561|Secondary|the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia||before anesthesia, after extubation ,1day after operation||||||
17084|NCT01842607|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population. Only those participants available at the indicated timepoints were analyzed (represented by n=X in the category titles).||Participants|||Number
17085|NCT01842607|Primary|Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions|AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])|As Treated (AT) Population: all participants who received at least one dose of open label mepolizumab.||Participants|||Number
17086|NCT01842594|Secondary|The Toxicity|Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0.|2 Weeks|||participants|||Number
17087|NCT01842594|Primary|The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan|A baseline whole-body [18F]-fluorodeoxyglucose(FDG) PET was performed before therapy initiation. Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. A second [18F]-FDG PET was performed after treatment completion. SUVs were calculated for all lesions. Regions of interest (ROI) were contoured to represent tumors (>2 cm) and organs (lungs, spleen, and liver) on all transaxial and coronal slices. ROIs were normalized for injection dose and body weight, and the maximum voxel value was recorded for each region or organ. The highest SUV measured with increased uptake was considered the SUVmax. Correlative diagnostic CT examinations were used for accurate localization of the lesions. The most intense uptake at baseline was identified as the index lesion and evaluated for treatment response.|2 Weeks|||percentage of the SUVmax Change|Participants|95% Confidence Interval|Mean
17088|NCT01842464|Primary|Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure|Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.|one year|occurrence and severity of complication is recorded||participants|||Number
17089|NCT01842464|Primary|Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring|Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.|one year|||participants|||Number
17090|NCT01842464|Primary|The Change With Distance Between the Vaginal Apex and the Introitus|The change with distance measured by centimeters, between the vaginal apex and the introitus|One year|||centimeters||Full Range|Mean
17091|NCT01842438|Secondary|SCORE15 (Systemic Core Outcome Measure)|SCORE15 is an index of Family Function and Change, with 15 items. The potential range of scores is 15 to 75, with a lower score indicating higher family functioning. Total scores are reported in the data below.|6months|Data received at each time-point was T0: intervention 42, control: 43; T1: intervention 36, control 36; T2 (as above) intervention 28, control 32||units on a scale||Standard Deviation|Mean
17092|NCT01842438|Secondary|HADS (Hospital Anxiety and Depression Scale)|"The HADS has two scales: one anxiety and one depression. It is validated with population norms. Results are presented for T2 (6 month follow-up) and split by Patient, Partner and again by Intervention, Control.~Responses are scored on a scale of 0–3 (3 indicates higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0–7, mild 8–10, moderate 11–14, and severe 15–21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress."|6months|28 and 32 refer to the number of individuals whose data was analysed at T2. Data received at each time-point was T0: intervention 42, control: 44; T1: intervention 36, control 36; T2 (as above) intervention 28, control 32||units on a scale||Standard Deviation|Mean
17093|NCT01842438|Primary|EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale|EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms. We used the sexual bother sub-scale as the primary outcome measure; score range 0-400. A higher score indicates better function/better outcome.|Immediate post-intervention|"At T1 (immediate follow-up) 3 intervention patients had withdrawn and 4 control patients had withdrawn.~The scale was completed only by patients (all of whom were men, by virtue of this study focusing on prostate cancer)."||units on a scale||Standard Deviation|Mean
17094|NCT01841970|Secondary|Mean Pain Score Based on the Visual Analog Pain Scale|Mean pain score based on the Visual Analog pain scale. Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.||units on a scale||Standard Deviation|Mean
17095|NCT01841970|Secondary|Pain Recorded Yes or No on Visual Analog Scale (VAS)|Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.||participants|||Number
17096|NCT01841970|Secondary|Recurrence of Symptoms That Had Resolved With Treatment|Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.||Participants|||Count of Participants
17099|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percentage of participants|||Number
17100|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percentage of participants|||Number
17101|NCT01841697|Secondary|Change From Baseline in FPG at Week 24|Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
17102|NCT01841697|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 24 weeks|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.||Percentage of participants|||Number
17103|NCT01841697|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 27 weeks (including 3-week follow-up)|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.||Percentage of participants|||Number
17104|NCT01841697|Primary|Change From Baseline in A1C at Week 24|A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
17105|NCT01841619|Primary|Skindex 29|The subjects also evaluated their skin-specific quality of life with the Skindex-29 − the questionnaire consisting of 29 items used to calculate three subscales: symptoms (pain, itch, burning, sensitivity), emotions (depression, anxiety, embarrassment, anger) and functioning (sleep, relationships with others). All assessments were repeated at all study visits. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
17106|NCT01841619|Secondary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS)|"Disease activity will be measured using the CLASI activity score that describes the damage of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.~All patients were measured identically in all visits."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
17107|NCT01841619|Primary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS)|"Disease activity will be measured using the CLASI activity score that describes the activity of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
17108|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
18110|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
17109|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit|||Percent of Baseline||Standard Deviation|Mean
17110|NCT01841593|Primary|Amlodipine AUC(0-24h)|AUC0-24h: Area under the concentration time curve 24 hours in the absence, and presence, of raltegravir|Post-dose on day 7 of daily dosing|||ng*h/mL||95% Confidence Interval|Geometric Mean
17111|NCT01841593|Primary|Raltegravir AUC(0-12h )|AUC0-12h: Area under the concentration time curve over 12 hours in the absence, and presence, of amlodipine.|Post dose after day 7 of daily dosing|||ng*h/mL||95% Confidence Interval|Geometric Mean
17112|NCT01841593|Primary|Amlodipine C24h|measured concentration 24 hours after dose in the absence, and presence, of raltegravir|12 hours post-dose on day 7 of daily dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
17113|NCT01841593|Primary|Raltegravir C12h|measured concentration 12 hours after dose in the absence, and presence, of amlodipine.|12 hours post-dose on day 7 of daily dosing.|||ng/mL||95% Confidence Interval|Geometric Mean
17114|NCT01841593|Primary|Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.|"To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration–time curve from 0–24 hours after dosing (AUC0–24h).~All pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0."|Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only))|Data from all enrolled participants who participated in at least two of the three PK assessments were included in the analysis.||ng/mL||95% Confidence Interval|Geometric Mean
17115|NCT01841567|Secondary|Overall Cost Regarding Dressing Wear Time||7 days||||||
17116|NCT01841567|Secondary|Pain Evaluation||7 days||||||
17117|NCT01841567|Secondary|Comfort, Comformability, Acceptability of the Dressing||7 days||||||
17118|NCT01841567|Secondary|Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.|The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery|7 days|||participants|||Number
17119|NCT01841567|Primary|Minimize the Risk of the Development of Blistering.|Number of participants without blisters at study visit|7 days|||participants|||Number
17120|NCT01841216|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard. The subject rated the intensity or resistance felt on each exercise on this scale. The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.|16 exercises during one 40 minute session|||units on a scale||Full Range|Mean
17121|NCT01841216|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.|One 40 minute session|||percentage of MVIC of gmax||Standard Deviation|Mean
17122|NCT01841021|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) to be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade.|Up to 24 months post treatment|All participants.||Participants|||Count of Participants
17123|NCT01841021|Secondary|Overall Survival (OS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Radiological assessments to be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival to be evaluated every 3 months until 2 years from the start of study treatment or until study closure.|24 months post treatment or until study closure|Participants evaluable at 24 months post treatment or at study closure.|||||
17124|NCT01841021|Secondary|Progression Free Survival (PFS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Stable disease (SD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|24 months post treatment|Participants evaluable at 24 months post treatment.|||||
17125|NCT01841021|Secondary|Time to Disease Progression (TTP)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Progressive disease (PD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|Up to 24 months post treatment|All participants.||months|||Number
20928|NCT01756391|Secondary|Prednisone Bursts||12 months||||||
20929|NCT01756391|Secondary|Unscheduled Physician/Health Care Visits||12 months||||||
17126|NCT01841021|Secondary|Duration of Response (DOR)|DOR: The number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1).|Up to 24 months post treatment|Participants with Complete Response or Partial Response.|||||
17127|NCT01841021|Secondary|Time to Response (TTR)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. TTR: The time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Participants who did not have a confirmed response to be censored at the date of the last tumor assessment.|Up to 24 months post treatment|Participants with Complete Response or Partial Response.|||||
17128|NCT01841021|Primary|Overall Response Rate (ORR)|ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.|Up to 24 months post treatment|All participants.||Participants|||Count of Participants
17129|NCT01840943|Secondary|Number of Participants With Adverse Events|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.|Up to 30 days after the last dose of study medication|Safety population included all randomized participants.||participants|||Number
17130|NCT01840943|Secondary|Apparent Volume of Distribution of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
17131|NCT01840943|Secondary|Systemic Clearance of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
17132|NCT01840943|Secondary|Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
17133|NCT01840943|Secondary|Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
17134|NCT01840943|Secondary|Area Under the Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
17135|NCT01840943|Secondary|Time to Reach the Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
17136|NCT01840943|Secondary|Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.|||||
17137|NCT01840943|Secondary|Number of Participants With Overall Survival|Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause.|Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier|The mITT population included all randomized participants.||participants|||Number
17138|NCT01840943|Secondary|Health-related Quality of Life Assessment (HQL)|Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life.|Day 1 of each cycle of study medication and Week 4 after last dose of study medication|Data was not collected for this outcome measure as the study was early terminated.|||||
17139|NCT01840943|Secondary|Duration of Response|It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause.|Up to 1 year of last dose (Week 24) administration|The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response.||weeks||95% Confidence Interval|Median
17140|NCT01840943|Secondary|Time to Response|It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements).|Up to Week 24|The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response.||weeks||Full Range|Median
17157|NCT01840410|Secondary|Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
20930|NCT01756391|Secondary|Emergency Department Visits||12 months||||||
17141|NCT01840943|Secondary|Number of Participants With Response|Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered.|Up to Week 24|The mITT population included all randomized participants.||participants|||Number
17142|NCT01840943|Secondary|Duration of Progression-free Survival|It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS.|1 year after the last dose (24 weeks) administration|The mITT population included all randomized participants.||weeks||95% Confidence Interval|Median
17143|NCT01840943|Primary|Number of Participants With Progression-free Survival Incidence at Week 24|Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Week 24|The modified intent-to-treat population included (mITT) included all randomized participants.||participants|||Number
17144|NCT01840605|Secondary|Patient Impression of Pruritus||2 ｗeeks||||||
17145|NCT01840605|Secondary|Severity of Atopic Dermatitis||2 ｗeeks||||||
17146|NCT01840605|Secondary|Pruritus Score||2 ｗeeks||||||
17147|NCT01840605|Primary|Change From Baseline in Pruritus Score|The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|2 weeks|||units on a scale||Standard Error|Least Squares Mean
17148|NCT01840410|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.||Number of primary reasons|Participants||Number
17149|NCT01840410|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.||Paticipants|||Number
17150|NCT01840410|Secondary|Number of Participants With Ranibizumab Treatments in Study Eye|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.||Participants|||Number
17151|NCT01840410|Secondary|Number of Participants With Requirement for Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at Month 1, were analyzed.||Participants|||Number
17152|NCT01840410|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||Participants|||Number
17153|NCT01840410|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||Participants|||Number
17154|NCT01840410|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.|Baseline (BL), Month 1 through Month 6, Month 1 through Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||letters||Standard Deviation|Mean
17155|NCT01840410|Secondary|Number of Participants With Presence of Active Chorioretinal Leakage|The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).|Baseline, Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||Participants|||Number
17156|NCT01840410|Secondary|Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline|Presence of subretinal fluid in study eye compared to baseline|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.||Participants|||Number
17158|NCT01840410|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||microliter (ul)||Standard Deviation|Mean
17159|NCT01840410|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||micrometer (um)||Standard Deviation|Mean
17160|NCT01840410|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.||letters||Standard Error|Least Squares Mean
17161|NCT01840410|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.|Baseline, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed.||letters||Standard Error|Least Squares Mean
17162|NCT01840319|Primary|Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline|Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants’ data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.|30 days after last dose of Tigecycline (Day 108)|Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591).||percentage of participants||95% Confidence Interval|Number
17163|NCT01840072|Secondary|Quality of Life|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. The information on the quality of life will be obtained.|3, 12 and 24 months||||||
17164|NCT01840072|Secondary|Cognitive Function|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. The information on the cognitive function will be obtained.|3, 12 and 24 months||||||
17165|NCT01840072|Secondary|Long-term Neurological and Functional Status|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Neurological and functional assessments including the modified Rankin scale and NIHSS will be performed.|3, 12 and 24 months||||||
17166|NCT01840072|Secondary|Other Vascular Events|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of vascular events, such as myocardial infarction, will be collected.|3, 12 and 24 months|||participants|||Number
17167|NCT01840072|Secondary|Recurrent Stroke|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent stroke will be collected.|3, 12 and 24 months|||participants|||Number
17168|NCT01840072|Secondary|Mortality|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information on clinical deaths will be obtained.|3, 12, and 24 months|||participants|||Number
17169|NCT01840072|Secondary|A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.|Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 3 months after randomization.|3 months||||||
17170|NCT01840072|Primary|A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.|The assessment using the modified Rankin scale will be obtained on 14 day after the randomization or at the hospital discharge.|2 weeks|||participants|||Number
17171|NCT01839695|Primary|Primary Effectiveness Observation|Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.|1 month|Based on the number of ITT subject with evaluable data, subjects were considered unevaluable for treatment success if the 30 day imaging was unable to assess patency of the MSG and BSG. One subject completed CT imaging at discharge, which was not repeated at the 30 day visit, and, therefore, was not considered evaluable for this assessment.||participants|||Number
17172|NCT01839695|Primary|Primary Safety Observation - Rate of Major Adverse Events (MAEs)|Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.|1 month|Includes active subjects in the ITT population at 30 days post-index procedure.||participants|||Number
17173|NCT01839318|Secondary|Total Wettability Score|The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.||units on a scale||Standard Deviation|Mean
17174|NCT01839318|Primary|Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.||seconds||Standard Deviation|Mean
17175|NCT01839279|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCt) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
17176|NCT01839279|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment||hour||Full Range|Median
17177|NCT01839279|Secondary|Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17178|NCT01839279|Secondary|Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling|The relationship will be quantified using a linear mixed effects model with an intercept. Data from Day 5 and Day 14 were fitted into regression model to obtain a slope of change. The measure type 'Number' followed by (90% Confidence Interval) shown in results is the slope from the linear fit.|Day 5, Day 14|Pk/QTc Analysis set will include all subjects in the QT/QTc analysis set with at least one valid PK assessment. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.||msec per ng/mL||90% Confidence Interval|Number
17179|NCT01839279|Secondary|The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 5 (Tizanidine 8 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 5|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.||msec||90% Confidence Interval|Least Squares Mean
17180|NCT01839279|Primary|The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 14 (Tizanidine 24 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 14|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
17181|NCT01838980|Primary|Mean of All Subjects Colon Segments BBPS>=2|"Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon).~Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2."|Following the colonoscopic procedure- Up to 24 hours.|"15 subjects were enrolled to the study.~1 was excluded. Total of 14 subjects were analyzed."||Mean of BBPS score per segment||Standard Deviation|Mean
17182|NCT01838941|Secondary|Developmental Status|Denver Developmental Screening Test expressed in years and months.|6 months|The Denver Developmental Screening Test was not performed.|||||
17183|NCT01838941|Primary|Peroxisome Biochemical Functions as Measured by Plasma Very Long Chain Fatty Acid|C26/C22 ratio in plasma is a recognized biomarker for very long chain fatty acid (normal range: 0.002-0.018). It was measured twice before the beginning of treatment and measured once at the end.|6 months|||ratio||Full Range|Mean
17184|NCT01838694|Primary|Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.||4 weeks|Analysis Population reflects participants for whom adequate analyzable samples were collected||percentage change from baseline||Standard Deviation|Mean
17185|NCT01838642|Secondary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of disease progression.|up to 6 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.||months||Full Range|Mean
17186|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Carcinoemybryonic Antigen (CEA) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal 0-2.5 mcg/L) following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CEA level relative to baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||||
17187|NCT01838642|Secondary|Objective Response to Ponatinib|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 4 cycles of treatment with ponatinib|One participant died on study during cycle 2. No participants were enrolled in the RET mutation negative group; study closed prematurely.||participants|||Number
17188|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Calcitonin (CTN) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal <10 pg/mL) following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CTN level relative to baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||||
17189|NCT01838642|Secondary|Molecular Differences in Advanced Medullary Thyroid Cancer (MTC)|Compare the molecular profile of tumor deoxyribonucleic acid (DNA) prior to treatment with the molecular profile at the time of progression. Prior to the first dose of ponatinib and at time of progression, subjects were to undergo a biopsy of the primary tumor or any metastatic site for analysis of tumor DNA for rearranged during transfection (RET) or rat sarcoma (RAS) mutation. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% decrease in the sum of diameters of target lesions, taking as reference the smallest sum on study.|Prior to the first dose of ponatinib|Although molecular profiling was to be completed prior to first dose of ponatinib and at time of progression, samples were tested on arrival only as mutational status was an eligibility requirement. No participants were enrolled in the RET mutation negative group; study closed prematurely.||participants|||Number
17190|NCT01838642|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|17 months and 19 days|No participants were enrolled in the RET mutation negative group; study closed prematurely.||participants|||Number
17191|NCT01838642|Secondary|Progression Free Survival|Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.||months||Full Range|Mean
17192|NCT01838642|Primary|Overall Response Rate.|Defined as the percentage of participants with a best response (complete response (CR) + partial response (PR)) recorded from the start of the treatment until disease progression/recurrence assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.||percentage of participants|||Number
17193|NCT01838616|Secondary|Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest.~The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit); End of Week 3 (End of Titration Period)|Safety Set (SAF).||number of events|||Number
17194|NCT01838616|Secondary|Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest.~The composition score from participant who reported:~Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit) to End of Titration Period (End of Week 3)|Safety Set (SAF).||participants|||Number
17195|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline (Randomization Visit); End of Continuation Visit (Week 12)|Full Analysis Set (FAS). Last Observation carried Forward (LOCF). Number of participants taken into account for the analyses.||hours||Standard Error|Least Squares Mean
17196|NCT01838616|Secondary|Sleep Evaluation: Latency (Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS).||hours||Standard Deviation|Mean
17977|NCT01819194|Primary|Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)|CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.|Post 3 days of wear|Subjects are those who were enrolled, randomized, and completed the study per protocol.||units on a scale||Standard Deviation|Mean
17197|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||hours||Standard Error|Least Squares Mean
17198|NCT01838616|Secondary|Sleep Evaluation: Number of Hours Slept|"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||hours||Standard Deviation|Mean
17199|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings|The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||number of awakenings||Standard Error|Least Squares Mean
17200|NCT01838616|Secondary|Sleep Evaluation: Number of Awakenings|"The participants were requested to answer the following question:~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||number of awakenings||Standard Deviation|Mean
17201|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||participants|||Number
17202|NCT01838616|Secondary|Clinician Global Impression of Change at the End of Treatment|In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||participants|||Number
17203|NCT01838616|Secondary|Patient Global Impression of Change at the End of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||participants|||Number
17204|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
17205|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17206|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
17292|NCT01835899|Secondary|AUCt,ss|Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
20931|NCT01756391|Secondary|Emergency Department Visits||12 months||||||
17207|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17208|NCT01838616|Secondary|Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
17209|NCT01838616|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17210|NCT01838616|Secondary|Changes in the Short Form Health Survey (SF-12) at the End of Treatment|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement since starting the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
17211|NCT01838616|Secondary|Short Form Health Survey (SF-12)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17212|NCT01838616|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
17213|NCT01838616|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17236|NCT01838044|Secondary|Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Percentage of participants|||Number
20932|NCT01756391|Secondary|Number of Hospitalizations||12 months||||||
17214|NCT01838616|Secondary|Change in painDETECT Final Assessment at the End of Treatment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
17215|NCT01838616|Secondary|painDETECT Final Assessment|The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being “negative” (had no neuropathic pain component). A value between 19 and 38 was rated as being “positive” (neuropathic component present). Values from 13 to 18 were scored as being “unclear”. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17216|NCT01838616|Secondary|Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”.~A negative change indicates that the pain intensity decreased from the start of the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
17217|NCT01838616|Secondary|Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”"|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17218|NCT01838616|Secondary|Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Error|Least Squares Mean
17219|NCT01838616|Secondary|Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.||units on a scale||Standard Deviation|Mean
17220|NCT01838616|Secondary|Change in Recalled Average Pain Intensity at the End of Treatment|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit).|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
17221|NCT01838616|Secondary|Recalled Average Pain Intensity|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
17237|NCT01838044|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10|The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
17306|NCT01835496|Secondary|Frequency of Serious Adverse Events||From Day 1 (Dosing) to Day 30 post-dose|||participants|||Number
17222|NCT01838616|Primary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS).||units on a scale||Standard Error|Least Squares Mean
17223|NCT01838616|Primary|Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)|"For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline Visit)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS). Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
17224|NCT01838590|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
17225|NCT01838590|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
17226|NCT01838590|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
17227|NCT01838590|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
17228|NCT01838590|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized and received at least one dose of study drug||percentage of participants|||Number
17229|NCT01838499|Secondary|Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain|"Assessment of change in pain via Numerical Rating Scale. Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale.~Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the average of the values collected in the 7 days prior to that visit."|12 weeks|FAS (LOCF)||changes in scores on a scale||Standard Error|Least Squares Mean
17230|NCT01838499|Secondary|"2) Subject’s Global Impression of Change Reported on PGIC Scale (1-7 Point Scale Ranging From 1 Very Much Improved to 7 Very Much Worse)"|"Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who are minimally improved, much improved or very much improved on the Patient's Global Impression of Change (PGIC)"|12 weeks|||% of patients|||Number
17231|NCT01838499|Primary|1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks|Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12|12 weeks|FAS||% of patients|||Number
17232|NCT01838213|Other Pre-specified|Carriage of ESBL Producing Bacteria|Culture results from patient fecal samples will be collected up to 3 years after urinary tract infection and carriage of ESBL producing bacteria will be examined.|up to 3 years||||||
17233|NCT01838213|Secondary|Subjective Outcome|A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.|14 days||||||
17234|NCT01838213|Primary|Treatment Failure|"Patients included in the study with urinary tract infection (UTI) and treated as part of normal routine were followed for 14 days and further prescriptions of antimicrobials normally used for treatment of UTI will be considered treatment failures. Only participants that received pivmecillinam are reported here. In the paper published in PlosOne High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli the mecillinam treatment group were compared with the group that did not receive mecillinam."|14 days after initiation of treatment|Patients that did receice pivmecillinam.||Treatment success|||Number
17235|NCT01838044|Secondary|Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Percentage of participants|||Number
17307|NCT01835496|Secondary|Frequency of Adverse Events||From Day 1 (Dosing) to Day 7 plus/minus 3 days (Follow-up)|||participants|||Number
17238|NCT01838044|Secondary|Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its ’worst,’ ’least,’ ’average,’ and ’now’ (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
17239|NCT01838044|Secondary|Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2|Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Period 1 and Period 2|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||% of days||Standard Deviation|Mean
17240|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
17241|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
17242|NCT01838044|Secondary|Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|"The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents ‘does not interfere with sleep’ and 10 represents ‘completely interferes’ which means you are unable to sleep due to pain."|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Least Squares Mean
17243|NCT01838044|Secondary|Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||percentage of participants|||Number
17244|NCT01838044|Secondary|Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Deviation|Mean
17245|NCT01838044|Secondary|Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Percentage of participants|||Number
17246|NCT01838044|Secondary|Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Baseline and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Least Squares Mean
17247|NCT01838044|Secondary|Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Least Squares Mean
17308|NCT01835496|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval|||μg/mL||Standard Deviation|Mean
17248|NCT01838044|Primary|Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Baseline and Week 5|The Full Analysis Set (FAS) that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).||Units on a scale||Standard Error|Mean
17249|NCT01837966|Primary|Anxiety Reduction|We hoped to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast. The Trait subscale (STAI-TRAID) of the Spielberger State-Trait Anxiety Inventory was administered before and after 10 minutes of aromatherapy treatment pre-surgery. The TRAIT subscale contains 20 questions scored on a Likert scale from 1-4; item scores are summed for a total score ranging from 20 to 80, with higher scores indicating higher anxiety. Change in anxiety was calculated as the score pre-aromatherapy minus the score post-aromatherapy. Higher positive change scores indicate greater reductions in anxiety.|20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)|Analysis of STAI-TRAIT questions||units on a scale||Standard Deviation|Mean
17250|NCT01837797|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.|From randomisation to end of treatment|15 patients were enrolled to Period 2, only 3 patients completed due to study termination||participants|||Number
17251|NCT01837797|Secondary|Sustained Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17252|NCT01837797|Secondary|Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17253|NCT01837797|Secondary|Sustained Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17254|NCT01837797|Secondary|Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17255|NCT01837797|Secondary|Change From Randomisation in Social Adaptation During the Randomised Treatment|Social Adaptation Self-evaluation Scale (SASS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17256|NCT01837797|Secondary|Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment|Sheehan Disability Scale (SDS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17257|NCT01837797|Secondary|Change From Randomisation in Clinical Global Impression During the Randomised Treatment|Clinical Global Impression - Severity of illness (CGI-S) score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17258|NCT01837797|Primary|Change From Randomisation in Depressive Symptoms During the Randomised Treatment|Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).|||||
17259|NCT01837797|Secondary|Number of Adverse Events|15 patients were enrolled to Period 2; only 3 patients completed due to study termination|From randomisation to follow-up|||Adverse events|||Number
17260|NCT01837719|Secondary|T-HALF of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Standard Deviation|Mean
17261|NCT01837719|Secondary|Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis. n=evaluable participants||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
17262|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Full Range|Median
17263|NCT01837719|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17264|NCT01837719|Secondary|Apparent Terminal Half-life (T-HALF) of Atazanavir|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Standard Deviation|Mean
17265|NCT01837719|Secondary|Observed Concentration at 24 Hours (C24) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. C24 was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17266|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||Hours||Full Range|Median
17267|NCT01837719|Secondary|Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded at predose and 4 hours post dose at screening, Days -1, 1, 8 15, 22, 29 and study discharge. ECGs were recorded after the patient had been supine for at least 5 minutes. All ECG readings post dosing (including unscheduled) were included.|At screening; on Day -1; predose and 4 hours postdose on Days 1, 18, 15, 22, and 29; and at study discharge (Day 31)|All participants who received at least 1 dose of study medication and were evaluable.||Participants|||Number
17268|NCT01837719|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment; h=high; hpf=high power field. Abnormal criteria: Leukocytes, low (*10^3 c/uL): <0.85*preRx if preRx<LLN; <0.9*LLN if LLN≤preRx≤ULN;< 0.9*LLN if preRx=missing;<LLN if preRX>ULN. Neutrophils, low (*10^3 c/uL): <0.85*preRx if preRx<1.5; <1.5 if preRx=missing; <1.5 if preRx ≥1.5. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Blood, urine, h: ≥2*preRx if preRx≥1; ≥2 if preRx <1; ≥2 if preRx=missing. RBCs/WBCs, h (hpf): ≥2 if preRx=missing ≥2 if preRx<2 ≥4 if preRx ≥2. Creatine kinase, h (U/L): >1.5*preRx if preRx>ULN; >1.5*ULN if preRx≤ULN; >1.5*ULN if preRx=missing; AST, h (U/L): >1.25* preRx if preRx>ULN; >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing. Lactate dehydrogenase, h (U/L): >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing; >1.5*preRx if preRx>ULN.|At Screening and on Days -1,4, 11, 18, and 31 (study discharge)|All participants who received at least 1 dose of study drug and had laboratory test results available.||Participants|||Number
17269|NCT01837719|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs)|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant who receives an investigational product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is any untoward medical occurrence that at any dose results in death; is life-threatening; or requires or prolongs inpatient hospitalization.|On Day 24 or 31|All participants who received at least 1 dose of any study drug.||Participants|||Number
17270|NCT01837719|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
17289|NCT01835912|Other Pre-specified|Rate of Perceived Exertion|"Rate of perceived exertion (RPE) was recorded after each 200 metre swimming performance~RPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion)~Numbers reported are the average of the RPE recorded for all 10 participants."|Rate of Perceived Exertion after each 200m swimming performance|||units on a scale (6-20)||Standard Error|Mean
17290|NCT01835912|Secondary|Lactate|lactate measured at 3min post trial|3 min post performance|||mmol/L||Standard Error|Mean
17271|NCT01837719|Primary|Maximum Observed Plasma Concentration (Cmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17272|NCT01837550|Secondary|Communication Strategies Scale (CSS)|CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.|5 weeks, 6 months|||units on a scale||Standard Deviation|Mean
17273|NCT01837550|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.|5 weeks, 6 months|||units on a scale||Standard Deviation|Mean
17274|NCT01837550|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.|pre-measurement|The IOI-HA was used only at the pre-masurement point, to select descriptive data about the participants.||units on a scale||Standard Deviation|Mean
17275|NCT01837550|Primary|The Hearing Handicap Inventory for the Elderly (HHIE)|The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.|5 weeks, 6 months|||units on a scale||Standard Deviation|Mean
17276|NCT01837537|Secondary|ME +/- 1 Breath Per Minute, Max-N Sensor|The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continuous monitoring|||BrPM||Standard Deviation|Mean
17277|NCT01837537|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the REspiration Rate calculated from capnography).|up to 40 minutes of continuous monitoring|90 subjects were enrolled but 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)||BrPM (breaths per minute)||Standard Deviation|Mean
17278|NCT01836809|Secondary|Total Diuretic Requirement||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
17279|NCT01836809|Secondary|Time to Renal Failure||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
17280|NCT01836809|Secondary|Urine Output||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
17281|NCT01836809|Secondary|Need for Hemodialysis/Renal Replacement Therapy||90 days|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
17282|NCT01836809|Primary|Renal Plasma Flow||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
17283|NCT01836809|Primary|Glomerular Filtration Rate||46 hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm|||||
17284|NCT01836458|Secondary|Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42|PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 & Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).|Day 28, Day 35 & Day 42|Pharmacodynamic Analysis Set includes all enrolled patients.||Percentage of Patients|||Number
17285|NCT01836458|Secondary|Median Time to Fever Clearance|Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.|Day 1 to Day 5|Pharmacodynamic Analysis Set includes all enrolled patients||hours||90% Confidence Interval|Median
17286|NCT01836458|Secondary|Median Time to Parasite Clearance|Parasite clearance time will be estimated using thick/thin blood films.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609|Pharmacodynamic Analysis Set includes all enrolled patients||hours||95% Confidence Interval|Median
17287|NCT01836458|Primary|Minimum Inhibitory Concentration (MIC) of KAE609|To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.|Up to Day 8 after a single dose of KAE609|The primary Outcome Measure (OM) could not be determined due to small sample size no data was collected from any participants.|||||
17288|NCT01836042|Primary|Rate of Sight-threatening Adverse Events|The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.|80 Month average|||percentage of subjects|||Number
20933|NCT01756391|Secondary|Nights of Wakening Due to Asthma Symptoms||12 months||||||
17293|NCT01835899|Secondary|Cmax,ss|Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
17294|NCT01835899|Secondary|AUC0-infinity|Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
17295|NCT01835899|Secondary|AUCt,1|Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
17296|NCT01835899|Secondary|Cmax|Maximum measured concentration of BI 1015550 in plasma.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint and who did not have a protocol violation relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
17297|NCT01835899|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug related Adverse events, as assessed by the investigator.|From first drug administration until last drug administration, upto 18 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||Percentage of participants|||Number
17298|NCT01835756|Secondary|Satisfaction With Study Outcome|"At study endpoint, the subject was asked to rate how satisfied he or she was with any overall change in low back pain attained following the procedure administration phase with the Erchonia MLS Laser, using the following five-point scale:~Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied~Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|4 Months|||participants|||Number
17299|NCT01835756|Secondary|Change in Low Back Pain Visual Analog Scale (VAS) Score|The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in low back pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of low back pain and is negative for study success. The mean change in low back pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 months post-procedure was calculated for each treatment group.|Baseline and 4 Months|||units on a scale||Standard Deviation|Mean
17300|NCT01835756|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups|Primary outcome success for an individual subject was defined as a 30% or greater change (decrease) in VAS pain score at 4 months post-procedure relative to baseline. The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score indicates a greater level of pain, and a lower score indicates a lower level of pain. A negative (-) percent change in VAS rating indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success was defined as a 35% or greater difference in the proportion of individual primary outcome successes in each treatment group, in favor of the active treatment group.|4 Months|||participants|||Number
17301|NCT01835743|Secondary|Change in Heel Pain Score on the Visual Analog Scale (VAS)|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Change in heel pain score on the VAS was calculated as the heel pain VAS score at week 5 (2 weeks after procedure administration end) minus the heel pain VAS score at baseline evaluation. A negative (-) change in heel pain VAS score across the evaluation period indicated a decrease (improvement) in heel pain and was positive for study success. A positive (+) change in heel pain VAS score indicated an increase (worsening) in heel pain and was negative for study success.|baseline and 5 weeks|||scores on a 0-100 VAS scale||Standard Deviation|Mean
17302|NCT01835743|Primary|Number of Participants Who Attained a Change of -30% or Greater in the VAS Score|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Percent (%) change in VAS score was calculated as the % difference in VAS score at week 5 (2 weeks after procedure administration end) relative to baseline evaluation. A negative (-) % difference in VAS score across the evaluation period indicated a decrease (improvement) in heel pain, and a positive (+) % difference in VAS score indicated an increase (worsening) in heel pain. A change of -30% or greater in the VAS score was considered positive for study success. The number of participants who attained a change of -30% of greater in VAS score across the evaluation period was calculated for both subjects in the test group and in th placebo group as a proportion of the total number of subjects in each procedure group.|baseline and 5 weeks|||participants|||Number
17303|NCT01835496|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 (apparent terminal elimination half-life) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval|||hr||Standard Deviation|Mean
17304|NCT01835496|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ (area under the curve, zero to infinity) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval|||µg*hr/mL||Standard Deviation|Mean
17305|NCT01835496|Primary|Tmax for Deferiprone and Deferiprone 3-O-glucuronide|"Tmax (time to the maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|10-hour interval|||hr||Full Range|Median
17309|NCT01835470|Secondary|Number of Participants With Positive Immunogenicity During the Short Term Period|A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose.|Day 1 up to Week 16 (Day 113)|Immunogenicity analysis population: All participants who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication||participants|||Number
17310|NCT01835470|Secondary|Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period|Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ug/mL||Geometric Coefficient of Variation|Geometric Mean
17311|NCT01835470|Secondary|Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period|Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ug/mL||Geometric Coefficient of Variation|Geometric Mean
17312|NCT01835470|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first.|Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months|All Treated Participants: All participants who received at least one dose of study medication||participants|||Number
17313|NCT01835470|Secondary|Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16|Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication||percentage of improvement from baseline||Inter-Quartile Range|Median
17314|NCT01835470|Secondary|Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16|ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician’s global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication||percentage of participants||95% Confidence Interval|Number
17315|NCT01835470|Primary|Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16|American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication||percentage of participants||95% Confidence Interval|Number
17544|NCT01830933|Primary|Knowledge of Breast Cancer Risk Factors|Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O|one week post-initial visit (approximately one week)|||units on a scale||Standard Deviation|Mean
17316|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
17317|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
17318|NCT01835431|Secondary|Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes|The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
17319|NCT01835431|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)|"Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).~Confirmed hypoglycaemic episodes were defined as episodes that were either:~Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or~An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator||episodes|||Number
17320|NCT01835431|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment.|After 16 weeks of treatment|The Safety analysis set (SAS) included all subjects receiving at least one dose of the trial product or its comparator||number of events|||Number
17321|NCT01835431|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|week 0, week 16|The FAS included all randomised subjects. 338 subjects had assessment at baseline, 326 had assessment at week 16, 2 subjects were withdrawn before exposure and 22 subjects week 16 assessment was not done.||mmol/L||Standard Deviation|Mean
17322|NCT01835431|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|Week 0 to week 16|The FAS included all randomised subjects. 20 subjects were withdrawn and only 4 subjects though completed the study did not have assesments.||percentage (%)||Standard Deviation|Mean
17323|NCT01835379|Secondary|Time to Wound Closure|Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.|During the 12 Week treatment period|||weeks||95% Confidence Interval|Median
17324|NCT01835379|Primary|Percentage of Wounds Closed||At the end of 12 Weeks|||percentage of wounds closed|||Number
17325|NCT01835262|Primary|Numeric Rating Scale of Pain|"We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes.~Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain"|30 minutes|||Units on a scale||Standard Deviation|Mean
17326|NCT01835132|Secondary|Changes in Scleral Grading From Baseline to Week 52|Scleral inflammation was summarized on an ordinal scale as either none, minimal/trace, mild, moderate, severe or necrotizing inflammation in the four quadrants of the study eye (superonasal [SN], superotemporal [ST], inferotemporal [IT], and inferonasal [IN]) for each participant at each visit. The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.|Baseline and Week 52||||||
17327|NCT01835132|Secondary|Number of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Post-injection through study completion, up to 78 weeks per participant|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||participants|eyes||Number
17328|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
17329|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
17978|NCT01818700|Secondary|Patients Global Impression og Change(PGIC)|Number of clinician with categorical change in overall status. PGIC: a participant-rated instrument assessing change in patient's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8 week|FAS set: 210. Missing values were imputed by LOCF.||participants|||Number
17330|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
17331|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
17332|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.~Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg)."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||mmHg|eyes|Standard Deviation|Mean
17333|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17334|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17335|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17336|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17337|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17338|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Mean Change in Intraocular pressure (IOP) is measured and reported as change in IOP between baseline and 24 weeks in millimeters of mercury (mmHg).|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17339|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17340|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17341|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17979|NCT01818700|Secondary|Clinician Global Impression of Change(CGIC)|Number of clinician with categorical change in overall status. CGIC: a clinician-rated instrument assessing change in clinician's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8weeks|FAS set: 210. Missing values were imputed by LOCF.||participants|||Number
17342|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17343|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17344|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||mmHg|eyes|Standard Deviation|Mean
17345|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
17346|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
17347|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
17348|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
17349|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.~Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.||ETDRS letters|eyes|Standard Deviation|Mean
17350|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17371|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hr*ng/mL||Standard Deviation|Mean
17351|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17352|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17353|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17354|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17355|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17356|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17357|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17358|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17359|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17403|NCT01833845|Primary|Efficacy|To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.|24 weeks||||||
17360|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17361|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.||ETDRS letters|eyes|Standard Deviation|Mean
17362|NCT01835132|Primary|Number of Participants With at Least a 2-step Reduction or Reduction to Grade 0 in Scleral Inflammation in the Study Eye (or Eyes), According to the National Eye Institute (NEI) Photographic Scleritis Grading System, on or Before the Week 16 Visit.|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show).|Baseline and Week 16|||participants|||Number
17363|NCT01835015|Secondary|Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
17364|NCT01835015|Secondary|The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
17365|NCT01835015|Secondary|Terminal Elimination Half-life (T½)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
17366|NCT01835015|Secondary|"Area Under the Serum Concentration-time Curve From Time Zero to Time t Where t is a Defined Time Point After Administration [AUC(0-t)]"|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.|||||
17367|NCT01835015|Secondary|Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hr*ng/mL/mg||Standard Deviation|Mean
17368|NCT01835015|Secondary|Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||ng/mL/mg||Standard Deviation|Mean
17369|NCT01835015|Secondary|Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hours||Standard Deviation|Mean
17370|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.||hr*ng/mL||Standard Deviation|Mean
17372|NCT01835015|Primary|Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment|A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.||participants|||Number
17373|NCT01835015|Primary|Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment|A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.||participants|||Number
17374|NCT01835015|Primary|Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye|IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||mmHg||Standard Deviation|Mean
17375|NCT01835015|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||letters||Standard Deviation|Mean
17376|NCT01834404|Secondary|Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)|Plasma gastrointestinal hormone PYY was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal|||pg/mL||Standard Error|Mean
17377|NCT01834404|Secondary|Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)|Plasma gastrointestinal hormone GLP-1 was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal|||pg/mL||Standard Error|Mean
17378|NCT01834404|Secondary|Peak Postprandial Level of Cholecystokinin (CCK)|Plasma gastrointestinal hormone CCK was measured by radioimmunoassay based on an antibody with very low cross-reactivity to gastrin 17 and its sulfated counterpart, and to sensitivity to a concentration of 0.3 pmol/L.|Day 14, approximately 45 minutes after liquid meal|||pg/mL||Standard Error|Mean
17379|NCT01834404|Secondary|Fasting Ghrelin|Plasma gastrointestinal hormone total ghrelin was measured by radioimmunoassay.|Day 14, before liquid meal|||pg/mL||Standard Error|Mean
17380|NCT01834404|Secondary|Change in Postprandial Gastric Volume|Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately approximately 30 min after liquid meal|||mL||Standard Error|Least Squares Mean
17381|NCT01834404|Secondary|Solid Gastric Emptying: Proportion Remaining at 4 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal remaining at 4 hours.|Day 15, approximately 4 hours after radiolabeled meal was ingested|||proportion of meal remaining||Standard Error|Least Squares Mean
17382|NCT01834404|Primary|Buffet Meal Intake|"At visit 4 subjects underwent imaging to measure the volume of their stomach, fasting and after ingesting a liquid nutrient drink. Four hours after the liquid meal, subjects were invited to eat, over a 30-minute period, a standard all you can eat meal vegetable lasagna, vanilla pudding, and skim milk. The total Kcal of the food consumed was analyzed by using validated software."|Day 13, approximately 4.5 hours after liquid meal|||Kcal||Standard Error|Mean
17383|NCT01834404|Primary|Maximum Tolerated Volume|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reached level 5.|Day 14, approximately 30 minutes after liquid meal|||mL||Standard Error|Mean
17384|NCT01834404|Primary|Volume to Fullness|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Day 14, approximately 30 minutes after liquid meal|||mL||Standard Error|Mean
18111|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
17385|NCT01834404|Primary|Postprandial Gastric Volume|Postprandial gastric volume was measured by 99mTc-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. After the liquid meal tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 30 minutes after liquid meal|||mL||Standard Error|Mean
17386|NCT01834404|Primary|Fasting Gastric Volume|Fasting whole gastric volume was measured by Technetium (99mTc)-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 10 minutes after Technetium (99mTC) injection|||mL||Standard Error|Mean
17387|NCT01834404|Secondary|Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.|Day 15, approximately 2 hours after radiolabeled meal was ingested|||proportion of meal emptied||Standard Error|Least Squares Mean
17388|NCT01834404|Primary|Gastric Emptying of Solids Half-Time (T 1/2)|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals.|Day 15, approximately 2 hours after radiolabeled meal was ingested|||minutes||Standard Error|Mean
17389|NCT01834274|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.||mmol/L||Standard Deviation|Mean
17390|NCT01834274|Secondary|Percentage of Participants With HbA1c <7% at Week 24|The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment.|Week 24|As pre-defined in the SAP, no summary is provided for the secondary efficacy endpoint incidence of HbA1c <7% at Week 24 due to the limited enrollment and study duration at the time of study termination.|||||
17391|NCT01834274|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.||Percent||Standard Deviation|Mean
17392|NCT01834027|Secondary|Mean Blood Pressure|non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes|60 minutes||||||
17393|NCT01834027|Secondary|Mean Difference in Patient's Perception of Pain From Baseline|The patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated.|10, 20 , and 30 minutes after baseline measurement|||units on a scale||95% Confidence Interval|Mean
17394|NCT01834027|Secondary|Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU|Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated.|Once, at 30 minutes after the patient entered the PACU|2 participants in the jazz group nad 1 participant in the no music group did not provide an anxiety score.||units on a scale||Standard Deviation|Mean
17395|NCT01834027|Primary|Change in Heart Rate From Baseline on Arrival in PACU|Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry|5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU|||beats per minute||95% Confidence Interval|Mean
17396|NCT01833897|Secondary|Beck's Depression Inventory|Range 0-63, with higher scores worse. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|8 weeks|||units on a scale (final score)||Standard Deviation|Mean
17397|NCT01833897|Secondary|Hamilton Anxiety Scale|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indi- cates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe.|8 weeks|||units on a scale (final score)||Standard Deviation|Mean
17398|NCT01833897|Secondary|HAM-D Suicide Item|Ham-D suicide item: range 0-4, higher scores indicate worse symptoms|8 weeks|||units on a scale (final)||Standard Deviation|Mean
17399|NCT01833897|Secondary|Loss of Motivated Behavior HAM-D Factor|includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms|8 weeks|bipolar depression||units on a scale (final score)||Standard Deviation|Mean
17400|NCT01833897|Primary|Hamilton Depression Rating Scale (HAM-D)|"Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|8 weeks|bipolar depression||units on a scale (final score)||Standard Deviation|Mean
17401|NCT01833845|Secondary|Efficacy|To evaluate the efficacy of 8 weeks monotherapy with RBV in HCV-infected patients.|8 weeks||||||
17402|NCT01833845|Primary|Safety: Number of Participants With Adverse Events|Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms.|all 24 weeks|||participants|||Number
20934|NCT01756391|Secondary|Days of Cough Without an Upper Respiratory Infection||12 months||||||
17404|NCT01833741|Primary|Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12||Percentage of Patients|||Number
17405|NCT01833741|Primary|Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12||Percentage of Patients|||Number
17406|NCT01833741|Secondary|Percentage of Patients Discontinuing Due to Ocular Adverse Events|Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.|12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percentage of Patients|||Number
17407|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
17408|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
17409|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
17410|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percent Change||Standard Deviation|Mean
17411|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percent Change||Standard Deviation|Mean
17412|NCT01833741|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit||Percent Change||Standard Deviation|Mean
17413|NCT01833741|Primary|Percentage of Treatment-Naive Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12||Percentage of Patients|||Number
17414|NCT01833533|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.||percentage of participants||95% Confidence Interval|Number
17415|NCT01833533|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).||percentage of participants|||Number
18112|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Tetanus|Summary of trough antibody concentrations prior to specified infusion for Tetanus|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||IU/mL||Standard Error|Mean
20935|NCT01756391|Secondary|Days of Exercise-induced Symptoms||12 months||||||
17416|NCT01833533|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
17417|NCT01833533|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.||percentage of participants|||Number
17418|NCT01833533|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
17419|NCT01833481|Primary|Kinematics - Overall Separation|Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance|6 months post-operative|||mm||Standard Deviation|Mean
17420|NCT01833481|Primary|Kinematics - Stance Phase Separation|Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.|6 months post-operative|||mm||Standard Deviation|Mean
17421|NCT01833481|Primary|Kinematics - Swing Phase Separation|Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.|6 months post-operatively|||mm||Standard Deviation|Mean
17422|NCT01833403|Primary|Insulin Sensitivity||Baseline|||m value||Standard Deviation|Mean
17423|NCT01833130|Secondary|Change From Baseline in the Emotional Function (EF) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17424|NCT01833130|Secondary|Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17425|NCT01833130|Secondary|Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17426|NCT01833130|Secondary|Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17427|NCT01833130|Secondary|Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17428|NCT01833130|Secondary|Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17545|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination (Vac)|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
17429|NCT01833130|Secondary|Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17430|NCT01833130|Secondary|Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17431|NCT01833130|Secondary|Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17432|NCT01833130|Secondary|Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17433|NCT01833130|Secondary|Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17434|NCT01833130|Secondary|Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17435|NCT01833130|Secondary|Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17436|NCT01833130|Secondary|Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17437|NCT01833130|Secondary|Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17438|NCT01833130|Primary|Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients||Scores on a Scale||Standard Deviation|Mean
17439|NCT01833117|Secondary|Area Under Curve (AUC) of TBUT From 0 to 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|0 to 60 minutes|This analysis population includes all randomized participants.||seconds x hours||Standard Deviation|Mean
17546|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.|||||
20936|NCT01756391|Secondary|Days of Slowed Activity Due to Asthma||12 months||||||
17440|NCT01833117|Primary|Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|Baseline, 60 minutes|This analysis population includes all randomized participants.||seconds||Standard Error|Mean
17441|NCT01833078|Secondary|Sustainability of Increased Caloric Intake|Sustained food intake of standardized meal from Days 1 compared to Day 7.|pre-treatment baseline (day 1) through day 7|||calories||Full Range|Median
17442|NCT01833078|Primary|Safety|1.Safety: # of participants with treatment emergent adverse events|pre-treatment baseline through 30 days following the last administration of study treatment day 7|||participants|||Number
17443|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
17444|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
17445|NCT01833065|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).~For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
17446|NCT01833065|Secondary|Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.~PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.~Total PAC-QOL score was averaged from the individual item score."|At Week 12|The ITT analysis set consisting of all randomized (as planned) patients.||Percentage of patients|||Number
17447|NCT01833065|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .~For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||Units on BSFS||95% Confidence Interval|Least Squares Mean
17448|NCT01833065|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.||SBM per week||95% Confidence Interval|Least Squares Mean
17449|NCT01833065|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).|Within first 24 hours of treatment initiation|The ITT analysis set consisting of all randomized (as planned) patients.||Percentage of patients|||Number
17450|NCT01833065|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|The ITT analysis set consisting of all randomized (as planned) patients.||Percentage of patients|||Number
18113|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV)|Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV)|Up to 1 year|Number available for analysis varied by infusion; 51-56 subjects||titer||Standard Error|Mean
17451|NCT01832766|Other Pre-specified|Brief Psychiatric Rating Scale Change From Baseline at 1 Hour|Measures psychiatric symptoms. Each item is scored from 1-7. Positive symptoms are calculated from sum of scores on hallucinatory behavior, unusual thought content and conceptual disorganization. Thus, the range of Total Positive Symptoms can be from a score of 3-21 .The higher the score, the more severe the symptom. Negative symptoms have been calculated from sum of blunted affect, emotional withdrawal and motor retardation. The range of Total Negative Symptoms can be from a score of 3-21. The higher the score, the more severe the symptoms. As this is a difference from baseline, there can be either negative or positive results as the subjects can either be better than baseline (positive score) or worse than baseline (negative score).|at 1 hour after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).||units on a scale||Standard Deviation|Mean
17452|NCT01832766|Secondary|California Verbal Learning Test Change at 2 Hours From Baseline|ability to remember a list of words given 5 trials. Number of words remembered is normalized to a schizophrenia population and average scores are calculated with age correction. The normal T-score is 50 and scores greater than 50 correspond with greater ability to remember words as compared to a schizophrenia population norm.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).||T scores||Standard Deviation|Mean
17453|NCT01832766|Primary|P50 Auditory Evoked Potential|electrophysiological measure of ability to filter extraneous stimuli measured as the amplitude of the evoked response to the second auditory stimulus divided by the amplitude of the evoked response to the first auditory stimulus in mV.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).||test to conditioning ratio||Standard Deviation|Mean
17454|NCT01832506|Secondary|Progression-free Survival (PFS)|PFS was defined as the time in months from the first administration of trial treatment until first observation of progressive disease (PD), or death due to any cause when death occurs within 12 weeks of the last tumor assessment or first administration of trial treatment (whichever is later). Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment. PFS was planned to be presented for “MSC2156119J Combined” reporting arm.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||months||90% Confidence Interval|Median
17455|NCT01832506|Secondary|Number of Subjects With Clinical Benefit|Clinical Benefit was defined as CR or PR at any time point or SD at week 12 or later, based on tumor assessment as determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
17456|NCT01832506|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
17457|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Multiple Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the LLQ. AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
17458|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Single Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLQ) AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
17459|NCT01832506|Secondary|Apparent Volume of Distribution Associated To The Terminal Phase (Vz/f) of MSC2156119J|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed and is calculated by Dose/(AUC(inf)*λz).|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of the Vz/f.|||||
17460|NCT01832506|Secondary|Apparent Body Clearance (CL/f) of MSC2156119J|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. CL/F = Dose/AUC(inf), where AUC(inf) =AUC0-t + AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.|||||
17461|NCT01832506|Secondary|Area Under the Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC[Inf]) of MSC2156119J|AUC(inf) was calculated by combining AUC0-t and AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUCinf.|||||
17462|NCT01832506|Secondary|Apparent Terminal Half-life (t1/2) of MSC2156119J|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base 2 (Ln2) divided by elimination rate constant (λz), where ‘λz’ is calculated by a linear regression of the log-linear concentration-time curve.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.|||||
17463|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.||hours||Full Range|Median
17464|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.||hours||Full Range|Median
17465|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17466|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|Pharmacokinetic (PK) analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect PK results and who received at least first dose of study drug according to protocol providing sufficient concentration time data to determine PK endpoints for the study drug.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
17467|NCT01832506|Secondary|Number of Subjects With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 2 or Higher|ECOG PS score is widely used by doctors and researchers to assess how a subjects’ disease is progressing, and is used to assess how the disease affects the daily living abilities of the subject, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 4, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.|Baseline up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
17468|NCT01832506|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs or TEAEs Leading To Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline Up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.||subjects|||Number
17526|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in PASI|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
17469|NCT01832506|Primary|Number of Subjects Experiencing Dose Limiting Toxicity (DLT)|DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (>=) Grade 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding; >=Grade 3 nausea despite adequate treatment; >=Grade 3 any non-hematological AE (DLT defined specifically for following cases: >=Grade 3 liver adverse event [AE] requiring recovery period of more than 7 days or to Grade 1 without liver metastases or Grade 2 with liver metastases ; >=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of >=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and >=Grade 2 any AE not otherwise defined as DLT that, due to prolonged recovery to Grade 1 (or less) or baseline status, led to delay of treatment with IMP for more than 21 days.|Cycle 1 (Day 1 up to 21)|DLT analysis set included all subjects who completed Cycle 1 (having received 80% or more of planned cumulative dose of IMP for Cycle 1) or who stopped treatment with IMP during Cycle 1 because of DLT.||subjects|||Number
17470|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.||participants|||Number
17471|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.||participants|||Number
17472|NCT01832493|Primary|AV Interval Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.||participants|||Number
17473|NCT01832493|Primary|AV Interval Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.||participants|||Number
17474|NCT01832155|Other Pre-specified|Feasibility Measure - Recruitment|The number of months it took to recruit 36 participants.|9 months|||months|||Number
17475|NCT01832155|Primary|Absolute Value of OA Pain at 8 Weeks|A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.|8 weeks|||Number of pain medication/day||Standard Error|Mean
17476|NCT01832155|Other Pre-specified|Feasibility Measure - Safety|Safety was assessed by measuring the frequency of yoga related injuries that occur from group or home-based exercise sessions during the active treatment periods.|8 weeks|||injuries|||Number
17477|NCT01832155|Other Pre-specified|Feasibility Measure - Acceptability|"Acceptability was evaluated by the participants' perceived difficulty of the yoga class and level of enjoyment. Upon completion of the yoga program, perceived level of program difficulty was rated by participants using a scale of 1 - 10 where 10 represents extremely difficult and a scale of 1 - 10 where 10 represents most enjoyable was used to measure perceived level of program enjoyment. Data from both intervention and wait-list control (during the intervention period) groups were collected."|8 weeks|||units on a scale||Full Range|Mean
17478|NCT01832155|Other Pre-specified|Feasibility Measures - Adherence|Feasibility was also measured by the home practice adherence rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Home yoga practice adherence was determined by participants' report of the average number of minutes of yoga practiced at home.|8 Weeks|||minutes/week||Full Range|Mean
17479|NCT01832155|Other Pre-specified|Feasibility Measures - Retention|Feasibility was measured by the retention rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Participants' class attendance (average number of classes attended) was evaluated.|8 weeks|||classes||Full Range|Mean
17480|NCT01832155|Secondary|Absolute Value of BMI at 8 Weeks|BMI was calculated using the participant's weight and height, kg/m^2.|8 weeks|||kg/m^2||Standard Error|Mean
17481|NCT01832155|Secondary|Absolute Value of Quality of Life at 8 Weeks|"The self-perceived quality of life was assessed using the Short Form Health Survey (SF-12) which measures a total of 8 health domains: 4 physical and 4 mental component summary scales. Physical Health (physical functioning, role-physical, bodily pain, and general health)and Mental Health (vitality, social functioning, role-emotional, and mental health) Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The Cantril Self-Anchoring Ladder that measures both current and in 5 years using steps from 0 to 10, where 0 represents the worst possible life and 10 represents the best possible life."|8 weeks|||units on a scale||Standard Error|Mean
17572|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17482|NCT01832155|Secondary|Absolute Value of Quality of Sleep at 8 Weeks|Pittsburgh Sleep Quality Index (PSQI) was used to measure quality of sleep. The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0–3 whereby 3 reflects the negative extreme on the Likert Scale. The 7 component scores are added to obtain a global score ranging from 0–21, with higher scores indicating worse sleep quality. A global score of ≥ 5 on the PSQI total scale, which is computed as a sum of the seven subscales (e.g., sleep quality, sleep latency, sleep duration, sleep disturbance, sleep efficiency, and use sleep medication) is associated with clinically significant sleep disruptions, including insomnia and major mood disorders.|8 weeks|||units on a scale||Standard Error|Mean
17483|NCT01832155|Secondary|Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks|"Secondary outcome measures included physical performance of the LE which was assessed using the Short Physical Performance Battery (SPPB) developed by the National Institute on Aging. The test consists of three components: repeated chair stands (4 points), balance (4 points), and timed 8 walk (4 points). A maximum score of 12 points can be achieved. Higher values indicate better physical functions."|8 weeks|||units on a scale||Standard Error|Mean
17484|NCT01832155|Primary|Absolute Value of OA Symptoms at 8 Weeks|Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks|||units on a scale||Standard Error|Mean
17485|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
17486|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
17487|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 8|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
17488|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 4|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
17489|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 8|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive ‘yes’ responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||grams||Full Range|Median
17490|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 4|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive ‘yes’ responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||grams||Full Range|Median
17527|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90–100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
17491|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant did not respond to air stimulation, 1 – participant responded to air stimulus but did not request discontinuation of stimulus, 2 – participant responded to air stimulus and requested discontinuation of stimulus, 3 – participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a Scale||Standard Deviation|Mean
17492|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant did not respond to air stimulation, 1 – participant responded to air stimulus but did not request discontinuation of stimulus, 2 – participant responded to air stimulus and requested discontinuation of stimulus, 3 – participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
17493|NCT01831791|Secondary|Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks|Blood samples for DHT analysis was collected at Baseline, Week 26 and Week 52. DHT values at a lower limit of quantification (LLQ) were imputed using 1/2 LLQ. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||nanomole per liter (nmol/L)||Standard Deviation|Mean
17494|NCT01831791|Secondary|Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52|The DLQI is a 10-item validated measure developed specifically to assess quality of life (QoL) in participants with dermatological conditions. It assesses six domains: symptoms and feelings, daily activities, leisure, work ⁄school, personal relationships, and treatment. The DLQI total is the sum of 10 questions, each ranging from 0 (unanswered/not relevant,not at all) to 3 (very much). The higher the score, the greater the impairment of (QoL). Change from Baseline in DLQI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39, and Week 52|ITT Population||Scores on a scale||Standard Deviation|Mean
17495|NCT01831791|Secondary|Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52|The Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) questionnaire was used to assess participant-perceived problems in sexual function using 3 questions assessing problems with sex drive, erections and ejaculation. They are scored on a 5-point scale of 0 to 4 (0=big problem, 1= medium problem, 2=small problem, 3=very small problem, 4=no problem). Total scores range from 0-12. Change from Baseline in PAS SFI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39 and Week 52|ITT Population||Scores on a scale||Standard Deviation|Mean
17496|NCT01831791|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at 26 Weeks and 52 Weeks|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than Stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Screening (Baseline), Week 26, and Week 52. v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. The number of participants with stage changes from Baseline are summarized. The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study."|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Participants|||Number
17525|NCT01831466|Secondary|Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17497|NCT01831791|Secondary|Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 26 and Week 52 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline (Screening) with those subsequently obtained at Week 26 and Week 52. This assessment was made separately based on the global photography of the vertex and frontal views. The LOCF method for missing data was used for the assessment, if a participants was missing the Week 26 global photograph, but has a global photograph from an earlier assessment (i.e., a withdrawal visit), then that photograph was assessed during the panel review.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||Scores on a scale||Standard Deviation|Mean
17498|NCT01831791|Secondary|Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Terminal hair count was based on the terminal hair(>=60 μm in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||Hair count||Standard Deviation|Mean
17499|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Target area hair width was based on the total width of the nonvellus hairs(>=30μm in width) within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. The BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||microns x 10^-3||Standard Deviation|Mean
17500|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52|Target area hair count is based on the nonvellus hair(>= 30 micrometer[μm] in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as post-BL value minus BL value. The BL value is defined as the latest assessment on or before the BL date(latest non-missing value of either treatment start date or randomization date). The last observation carried forward(LOCF) method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.||Hair count||Standard Deviation|Mean
17501|NCT01831791|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants answering yes/no responses to questions about suicidal ideation (Question [Que] 1 and Que 2) at Baseline and post-Baseline (since last visit) and suicidal behaviors (Que 6 – Que 10) at post-Baseline (since last visit) are presented. Questions included the presence (yes) or absence (no) of the following: Que 1 - a wish to be dead; Que 2 - nonspecific (NS) active suicidal thoughts; Que 6 - preparatory acts or behavior; Que 7 - aborted attempt; Que 8 - interrupted attempt (int. att.); Que 9 - non-fatal actual suicide attempt; Que 10 - completed suicide and non-suicidal self-injurious behavior. Final assessment (FA) is the last post-Baseline measurement during the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
17502|NCT01831791|Primary|Mean Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign monitoring included heart rate measurement at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in heart rate is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline visit, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Beats per minute||Standard Deviation|Mean
17538|NCT01831219|Secondary|Harris Hip Score|The Harris Hip Score will be measured to determine clinical outcome. The Harris Hip total score ranges 100 (best) to 0 (worst) and it is computed by the sum of the pain score (0–44 points), function (, 0–47 points), absence of deformity (4 points), and range of motion (5 points).|2 months|||units on a scale|Hips|Standard Deviation|Mean
17503|NCT01831791|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
17504|NCT01831791|Primary|Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline|Blood samples for the assessment of the indicated laboratory parameters were taken at the Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. The laboratory parameters included ALP, ALT, AST, total bilirubin, total protein, sodium, potassium, albumin, glucose, creatinine, urea/BUN, hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, and prostate-specific antigen (PSA). A laboratory value (LV) that is within the normal range is considered normal. A LV that is above the upper limit of the normal range is considered high abnormal. A LV that is below the lower limit of the normal range is considered low abnormal. Number of participants with any LV shifts from BL at any time post-BL are presented for, normal at BL to abnormal; normal at BL to high; normal at BL to low; normal or low at BL to high; normal or high at BL to low.|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only participants with a normal BL and at least one post-BL LV are analysed. ITT Population (represented by n=X in the category titles).||Participants|||Number
17505|NCT01831791|Primary|Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points|Blood samples were collected for the measurement of prostate-specific antigen at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the prostate-specific antigen value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Microgram per liter (µg/L)||Standard Deviation|Mean
17506|NCT01831791|Primary|Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for the measurement of potassium, sodium, glucose and urea/BUN at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the potassium, sodium, glucose and urea/BUN values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
17507|NCT01831791|Primary|Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the total bilirubin and creatinine values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
17508|NCT01831791|Primary|Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALT, ALP and AST at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the ALT, ALP and AST values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Units per liter (U/L)||Standard Deviation|Mean
17539|NCT01831219|Primary|Western Ontario and McMaster Universities Osteoarthritis Index|The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome. The WOMAC total score ranges 96 (best) to 0 (worst). The WOMAC pain score ranges 0–20, the stiffness score ranges 0–8, and functional limitation score ranges 0–68.|2 months|||units on a scale|Hips|Standard Deviation|Mean
17509|NCT01831791|Primary|Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points|Blood samples were collected for the measurement of the red blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the red blood cell count value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
17510|NCT01831791|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points|Blood samples were collected for the measurement of platelet count and white blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the platelet count and white blood cell count values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
17511|NCT01831791|Primary|Mean Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for the measurement of hematocrit at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hematocrit value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of red blood cells in blood||Standard Deviation|Mean
17512|NCT01831791|Primary|Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for the measurement of hemoglobin, albumin and total protein at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hemoglobin, albumin and total protein values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
17513|NCT01831791|Primary|Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit|A qualitative breast examination was performed at Baseline (Week 0), at the Week 26 Visit and at the Week 52 Visit (and at the early withdrawal visit, if applicable). Participants were assessed for presence (reported as yes) and absence (reported as no) of palpable breast tissue (PBT) or nipple tenderness (NT) and/or clinically significant (CS) PBT or NT at Baseline (BL), at each scheduled Post-BL assessment. Change from BL in breast examination results included the number of participants with change from ‘no (N)’ at BL to ‘yes (Y)’ at any Post-BL assessment for the presence of PBT or NT, and the number of participants with change from N at BL in CS to Y at any Post-BL assessment in CS for PBT and for NT. BL value of an assessment is defined as the latest assessment on or before the BL date (latest non-missing value of either the treatment start date or the randomization date).|Baseline to Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
17514|NCT01831791|Primary|Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE)|An AE is considered drug-related if the relationship variable indicates so, or if the variable value is missing. Any AE with a start date on or after the treatment start date and on or before the last dose of treatment is considered on-treatment (treatment-emergent). This includes an AE with a missing onset date. Any AE which occurred, in the investigator’s judgement and is possibly related to suicidality, is defined as possible suicidality-related adverse event (PSRAE). Suicidality was assessed by using the columbia-suicide severity rating scale (C-SSRS) as determined by the investigator. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.|From Baseline (Week 0) until Week 52|ITT Population||Participants|||Number
17540|NCT01831219|Primary|Presence of Osteolysis|Presence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.|14 months|||Hips|Hips||Number
17541|NCT01830933|Primary|Percentage of Participants Who Reported Discussion of Mammography Screening|Self reported discussion of mammography with physician.|up to 14 months|||percentage of participants|||Number
17542|NCT01830933|Primary|Percentage of Participants Who Had a Discussion of Breast Cancer Risk|Self-reported discussion of breast cancer risk with physicians.|one week post-initial visit (approximately one week)|||percentage of participants|||Number
17515|NCT01831791|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, drug-induced liver injury, breast cancer in male participants, prostate cancer, spontaneous abortion in female partner of male participants|From Baseline (Week 0) until Week 52|Intent-to-Treat (ITT) Population: comprised of all participants who received a randomization number, regardless of whether or not treatment was administered||Participants|||Number
17516|NCT01831466|Secondary|Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 8|FASm. Only observed data were analyzed.||Percentage of Participants|||Number
17517|NCT01831466|Secondary|Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 12|FASm. Only observed data were analyzed.||Percentage of Participants|||Number
17518|NCT01831466|Secondary|Change From Baseline to Week 8 in the DLQI Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 8|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
17519|NCT01831466|Secondary|Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 12|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
17520|NCT01831466|Secondary|Change From Baseline to Week 8 in Clinic-Based ISI Scores|The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their “worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “no itching” (0) and “worst possible itching” (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).|Baseline, Week 8|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
17521|NCT01831466|Secondary|Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores|The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their “worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “no itching” (0) and “worst possible itching” (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).|Baseline, Week 12|FASm. Only observed data were analyzed.||Score on a Scale||Standard Deviation|Mean
17522|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
17523|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.||Percent Change from Baseline||Standard Deviation|Mean
17524|NCT01831466|Secondary|Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17543|NCT01830933|Primary|Percentage of Participants With Correct Perception of Risk|This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.|baseline, one week post-initial visit (approximately one week)|||percentage of participants|||Number
17528|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17529|NCT01831466|Secondary|Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17530|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17531|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 12|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17532|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17533|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (erythema [E], induration [I], and scaling [S]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 12|The mild/moderate full analysis set (FASm) included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.||Percentage of Participants|||Number
17534|NCT01831219|Other Pre-specified|Number of Operated Hips That Required Revision/Reoperation|Implant survivorship will be determined from the medical history CRF by comparing the percentage of ROBODOC and manual control subjects who have required revision or re-operation THA procedures on the hip in question since their original study procedure which took place 7-20 years previously.|At follow-up visit (7-20 years post-operatively)|||Hips|Hips||Number
17535|NCT01831219|Secondary|Visual Analog Pain Score|The Visual Analog Scale pain questionnaire will be used to measure clinical outcome. The pain VAS is a continuous scale which range from 0 (no pain) to 100 [100-mm scale] (“worst imaginable pain” ).|2 months|||units on a scale|Hips|Standard Deviation|Mean
17536|NCT01831219|Secondary|UCLA Activity Score|The UCLA Activity Score will be used to measure clinical outcome. The UCLA Activity Score ranges 10 (best) to 0 (worst).|2 months|||units on a scale|Hips|Standard Deviation|Mean
17537|NCT01831219|Secondary|Health Status Questionnaire-12|The Health Status Questionnaire-12 (HSQ-12) will be used to measure clinical outcome. HSQ-12 total score ranges from 0 (worst) to 800 (best).|2 months|||units on a scale|Hips|Standard Deviation|Mean
17628|NCT01829919|Primary|Kel (Hour^-1) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hour^(-1)||Standard Deviation|Mean
17547|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary outcome measure ‘Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
17548|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
17549|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination||Before vaccination (Vac) 1, 1 Month after Vac 2|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||titer||95% Confidence Interval|Geometric Mean
17550|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination||One month after second, third vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.||percentage of participants||95% Confidence Interval|Number
17551|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.||percentage of participants||95% Confidence Interval|Number
17552|NCT01830855|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point.||percentage of participants||95% Confidence Interval|Number
17553|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain.||titer||95% Confidence Interval|Geometric Mean
17554|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
17555|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.||percentage of participants||95% Confidence Interval|Number
17629|NCT01829919|Primary|Cmax (ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
17556|NCT01830855|Primary|Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
17557|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
17558|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
17559|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
17560|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17561|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination||Within 30 Days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17562|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
17563|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
17564|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
17565|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available.||percentage of participants||95% Confidence Interval|Number
17566|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.||percentage of participants||95% Confidence Interval|Number
17567|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17568|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 Days After any Vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17569|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
17570|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
17571|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
17630|NCT01829919|Primary|AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hour*ng/mL||Standard Deviation|Mean
17573|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.||percentage of participants||95% Confidence Interval|Number
17574|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17575|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17576|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
17577|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
17578|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
17579|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17580|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.||percentage of participants||95% Confidence Interval|Number
17581|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17582|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.||percentage of participants||95% Confidence Interval|Number
17583|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||percentage of participants||95% Confidence Interval|Number
17584|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||percentage of participants||95% Confidence Interval|Number
17585|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.||percentage of participants||95% Confidence Interval|Number
17586|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, number of participants analyzed signifies participants with known values after third vaccination.||percentage of participants||95% Confidence Interval|Number
17587|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.||percentage of participants||95% Confidence Interval|Number
18114|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B|Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
17588|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.Here,number of participants analyzed signifies participants with known values after the first vaccination.||percentage of participants||95% Confidence Interval|Number
17589|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.Here,number of participants analyzed signifies participants with known values after third vaccination.||percentage of participants||95% Confidence Interval|Number
17590|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.||percentage of participants||95% Confidence Interval|Number
17591|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination. Here,number of participants analyzed signifies participants with known values after the first vaccination.||percentage of participants||95% Confidence Interval|Number
17592|NCT01830855|Primary|hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain.||titer||95% Confidence Interval|Geometric Mean
17593|NCT01830855|Primary|Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
17594|NCT01830790|Secondary|Change in Central Foveal Thickness as Assessed by Optical Coherence Tomography (OCT)||Baseline, 1hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.|||||
17595|NCT01830790|Primary|Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT)||Baseline, 1 hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.|||||
17596|NCT01830699|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.|4 weeks|||participants|||Number
17597|NCT01830699|Secondary|Improvement in Pain|Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).|4 weeks|||units on a scale||Standard Deviation|Mean
17598|NCT01830699|Primary|Improvement in Shoulder Function|The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: < 15 = no problem, 16 - 40 = problem, but working, > 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.|4 weeks|||units on a scale||Standard Deviation|Mean
17599|NCT01830205|Secondary|Number of Participants With Out-of-range Vital Signs Reported as Adverse Events|The total number of participants with abnormal range vital signs which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.||Participants|||Number
17600|NCT01830205|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events|The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.||Participants|||Number
17601|NCT01830205|Secondary|Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events|Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.|Baseline up to Day 5 post dose|The analysis was done in safety population.||Participants|||Number
17728|NCT01825577|Primary|Timed Get Up and Go Test - Measure of Mobility|Timed Get Up and Go Test (TUG), is used to evaluate the ability to walk by measuring the time it takes to rise from a chair, walk 10 feet, turn around, walk back to the chair, and sit down. The TUG test takes less than 5 minutes to complete. Scored as seconds required to complete the task.|Baseline and Post-test at 4 weeks|Elderly patients living in community nursing homes identified as fall risks with a diagnosis of probable Alzheimer's disease.||seconds||Standard Deviation|Mean
17602|NCT01830205|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died|Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs|Analysis was done in safety data set population, defined as all the participants who received the study medication.||Participants|||Number
17603|NCT01830205|Secondary|Apparent Volume of Distribution (Vd/F) of Daclatasvir|The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||Liters||Geometric Coefficient of Variation|Geometric Mean
17604|NCT01830205|Secondary|Renal Clearance (CLR) of Daclatasvir|The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
17605|NCT01830205|Secondary|Percent Urinary Recovery (%UR) of Daclatasvir|The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.||Percentage of daclatasvir recovered||Geometric Coefficient of Variation|Geometric Mean
17606|NCT01830205|Secondary|Unbound Apparent Clearance (CLU/F) of Daclatasvir|The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
17607|NCT01830205|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir|Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
17608|NCT01830205|Secondary|Plasma Half-life (T-half) of Daclatasvir|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||hours||Geometric Coefficient of Variation|Geometric Mean
17609|NCT01830205|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||hours||Full Range|Median
17610|NCT01830205|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir|AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
17611|NCT01830205|Secondary|Unbound Maximum Observed Plasma Concentrations of Daclatasvir|Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17612|NCT01830205|Secondary|Maximum Observed Plasma Concentration (Cmax) of Daclatasvir|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17613|NCT01830205|Secondary|Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir|AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
17614|NCT01830205|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir|AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|PK data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on the C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
17615|NCT01830140|Primary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
17616|NCT01830127|Secondary|SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.|4 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.||Percentage of participants||95% Confidence Interval|Number
17617|NCT01830127|Primary|SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.|12 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.||Percentage of participants||95% Confidence Interval|Number
17618|NCT01829919|Primary|Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"C(t) is the measured plasma level Concentration of the drug at time = t expressed as nanograms per milliliter."|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
17619|NCT01829919|Primary|Cavg,ss (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
17620|NCT01829919|Primary|Fluctuation Index (%) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Fluctuation Index is (Cmax-Cmin)/Cavg,ss. It is peak trough fluctuation within one dosing interval at steady state.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Percentage of steady state concentration||Full Range|Mean
17621|NCT01829919|Primary|Accumulation Index Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg at Day 19|Accumulation Index is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. In this case the steady state Accumulation Index was calculated at Day 19. Accumulation Index is calculated at the end of the dosing period.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Ratio||Full Range|Mean
17622|NCT01829919|Primary|Tmax (Hour) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hours||Full Range|Mean
17623|NCT01829919|Primary|Cmin (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
17624|NCT01829919|Primary|Cmax (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||ng/mL||Standard Deviation|Mean
17625|NCT01829919|Primary|AUC (Hour*ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hour*ng/mL||Standard Deviation|Mean
17626|NCT01829919|Primary|Median t1/2 Single Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||hours||Full Range|Median
17627|NCT01829919|Primary|Mean t1/2 Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.||Hours||Standard Deviation|Mean
17631|NCT01829516|Secondary|Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.|We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated.|Administered at visits 2 and 3|1 subject did not complete the RMET task, so only 31 participant responses were analyzed for this task.||Mean percent correct responses||Standard Error|Mean
17632|NCT01829516|Primary|Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.|Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.|Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.|In this crossover study a total of 32 participants were analyzed for each intervention.||units on a 7-pt Likert Scale||Standard Error|Mean
17633|NCT01829477|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose value collected at week 24 or final visit relative to baseline.|Baseline and Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
17634|NCT01829477|Secondary|Percentage of Participants With HbA1c <7 % at Week 24.||Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
17635|NCT01829477|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|In accordance with the Statistical Analysis Plan (SAP), due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.|||||
17636|NCT01829464|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose values collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
17637|NCT01829464|Secondary|Percentage of Participants With HbA1c <7%||Week 24|Due to the relatively limited enrollment and follow-up at the time of study termination, the analysis of percentage of participants with HbA1c <7% at Week 24 was not performed.|||||
17638|NCT01829464|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
17639|NCT01829399|Secondary|Pain Score at Time of Tq Deflation|A visual analog pain score (VAS) from 0 to 10 was assessed at the time of Tq deflation. 0 indicating no pain, and 10 indicating the worst possible pain. All participants requested deflation prior to the maximum allowable 60 minutes, Subjects were instructed to request deflation at the same degree of discomfort for each visit. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.|||scores on a scale||95% Confidence Interval|Mean
17640|NCT01829399|Primary|Time in Minutes That Tq Remained Inflated|15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.|||Minutes||95% Confidence Interval|Mean
17641|NCT01829243|Secondary|MATRICS Consensus Cognitive Battery Composite Score|"(MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.~The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
17642|NCT01829243|Primary|Composite Brief Assessment of Cognition (BAC) Score|The composite BAC score is calculated by scoring each of the 6 individual tests (Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London), comparing each score to a healthy control sample to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
17643|NCT01829243|Primary|Changes in The Fatigue Severity Scale (FSS)|"The Fatigue Severity Scale (FSS) is composed of nine items with a seven-point response format. The minimum score = 9 and maximum score possible = 63. Higher scores = greater fatigue severity.~Sample questions include I am easily fatigued and Exercise brings on my fatigue. In the initial validation study, internal consistency for the Fatigue Severity Scale was high for specific illness groups (MS and lupus) and healthy controls. The scale clearly distinguished patients from controls and it was moderately correlated with a single-item visual analogue scale of fatigue intensity. In all patients, clinical improvement in fatigue was associated with reductions in scores on the Fatigue Severity Scale. The Fatigue Severity Scale is also a practical measure due to its brevity and ease of administration and scoring."|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.||units on a scale||Full Range|Mean
17644|NCT01829243|Primary|Visual Analogue Scale for Pain|Visual Analogue Scale for Pain operationally is a 100 mm line anchored by word descriptors at each end. The patient marks a point on the line that reflects their current pain state. The distance in mm from the left anchor point is the score. Higher scores indicate more pain.|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.||mm||Full Range|Mean
17645|NCT01829230|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.|Baseline and every 6 months up to 18 months|All subjects who have at least one data point.||diopter (D)||Standard Deviation|Mean
17646|NCT01829230|Primary|Axial Length of the Eye|Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.|Baseline and every 6 months post-baseline up to 18 months|All subjects who have at least one data point.||millimeter (mm)||Standard Deviation|Mean
17647|NCT01829191|Secondary|Axial Length|Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.|Baseline and every 6 months for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||millimeter (mm)||Standard Deviation|Mean
17648|NCT01829191|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||diopter (D)||Standard Error|Mean
17649|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)|N=25 in the lowest quartile (Q1) Placebo N=10; SBI 2.5g N=7; SBO 5.0 g N=8|Baseline and 4 weeks|N=25 in the lowest quartile (Q1) Placebo N=10; SBI 2.5g N=7; SBO 5.0 g N=8 N= 26 for Q2 Placebo N=14; SBI 2.5g N=6; SBO 5.0 g N=6 N= 26 for Q3 Placebo N=1; SBI 2.5g N=10; SBO 5.0 g N=15 N = 25 for Q4 Placebo N=10; SBI 2.5g N=11; SBO 5.0 g N=4||cells/microliter||Standard Deviation|Mean
17650|NCT01828593|Primary|Frequency of Daily Unformed Bowel Movements|Change in number of abnormal or unformed stools by week 4|Baseline and 4 weeks|||abnormal or unformed stools||Standard Deviation|Mean
17651|NCT01828281|Other Pre-specified|Mean Hours of CPAP Usage Per Day|Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.|3 months|||hours||Standard Deviation|Mean
17652|NCT01828281|Secondary|Mean Changes in Adiponectin Over 3 Months|Mean changes in Adiponectin from baseline to 3 months.|Baseline, 3 months|||ug/ml||Standard Deviation|Mean
17653|NCT01828281|Primary|Mesenteric Fat Thickness||3 months|||cm||Standard Deviation|Mean
17654|NCT01828216|Secondary|Difference in Healthcare Costs Between Ambulatory and Hospital Approach||within 24 months|||Hong Kong Dollars||Standard Deviation|Mean
17655|NCT01828216|Primary|Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0–9 range is considered to be normal while a number in the 10–24 range indicates that expert medical advice should be sought.|Baseline and 3 months|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.||units on a scale||Standard Deviation|Mean
17656|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline - Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a Scale||Standard Deviation|Mean
17843|NCT01822197|Secondary|Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0|Quality of life scoring at admission (Day 0) and post-treatment (Day 7) using the CF questionnaire-revised (CFQ-R) as a measure of health related quality of life. Minimally important changes in CFQ-R scoring have been reported at 5–8. Days 0 and 7 will be compared. Score range is 0 to 100. Lower scores indicate worse quality of life.|between day 0 and day 7 of hospitalization|||units on a scale||Standard Deviation|Mean
17657|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a Scale||Standard Deviation|Mean
17658|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Grams||Standard Deviation|Mean
17659|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Grams||Standard Deviation|Mean
17660|NCT01827670|Secondary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject’s response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a Scale||Standard Deviation|Mean
17661|NCT01827670|Primary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject’s response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2||Score on a scale||Standard Deviation|Mean
17662|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
17663|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
17664|NCT01827592|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).~For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on a scale||95% Confidence Interval|Least Squares Mean
17860|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||% perception of presented words||Standard Deviation|Mean
17665|NCT01827592|Secondary|Total Patient Assessment of Constipation – Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.~PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.~Total PAC-QOL score was averaged from the individual item score."|At 12 weeks|The ITT analysis set consisted of all randomized (as planned) patients.||Percentage of patients|||Number
17666|NCT01827592|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .~For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||Units on BSFS||95% Confidence Interval|Least Squares Mean
17667|NCT01827592|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.||SBM per week||95% Confidence Interval|Least Squares Mean
17668|NCT01827592|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).|Within the first 24 hours of treatment initiation|The ITT analysis set consisted of all randomized (as planned) patients was used for assessment.||Percentage of patients|||Number
17669|NCT01827592|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|Intention-to-treat (ITT) analysis set consisted of all randomized (as planned) patients.||Percentage of patients|||Number
17670|NCT01827475|Secondary|Need for Rescue Pain Relief|The need for additional analgesics|1 hour|||participants|||Number
17671|NCT01827475|Primary|Pain Severity|Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)|1 hour|||mm||95% Confidence Interval|Mean
17672|NCT01827371|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with IMVAMUNE was determined by the investigator and defined as Related, meaning a reasonable possibility that the study product caused the adverse event. Reasonable possibility was defined as there being evidence to suggest a causal relationship between the study product and the adverse event."|Day 1 after the first vaccination through 180 days after the 2nd vaccination.|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.||participants|||Number
17673|NCT01827371|Secondary|Geometric Mean Peak ELISA Titer After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of antibody titers by ELISA. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through 31 after the 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.||titers||95% Confidence Interval|Geometric Mean
17674|NCT01827371|Primary|Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration|Participants maintained a memory aid to record daily the occurrence of local injection site reactions for 15 days after vaccination based on their interference with daily activities (pain and itchiness at injection site, underarm pain and swelling) or based on a quantitative measurement of the reaction (redness, swelling). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions were present but did not interfere with daily activities. For the quantitative scale, severe reactions greater than 30 millimeters (mm), moderate reactions were 15-30mm, and mild reactions were 1-15mm. Participants are counted by the maximum severity on any of the 15 days, and for this outcome measure, only those reporting moderate or severe events are counted. Formal comparisons by Fisher's Exact test were conducted for Arm D (Stratis, Day 1,29) compared to A|15 days after each vaccination|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.||percentage of participants|||Number
17675|NCT01827371|Primary|Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through Day 31 after 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.||titers||95% Confidence Interval|Geometric Mean
17676|NCT01827332|Secondary|Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )|Subjects' marijuana use was measured via self-report of number of smoking sessions per day (Time Line Followback). The average number of daily sessions were calculated per group, with data presented below representing the change in amount of daily smoking sessions per group from first MET session to last MET session.|Self-report of average daily smoking sessions at MET Session 1 and last MET session 3|||daily smoking sessions||Standard Error|Mean
17677|NCT01827332|Primary|Therapy Session Satisfaction (as Measured by Subjective Report)|After MET sessions, subjects completed the Session Rating Scale (SRS, Miller et al). This visual analog scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall, with minimum score 0 representing most dissatisfied and maximum score 10 representing most satisfied. Outcome measure reported below represents SRS score at last MET session.|Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit|||units on a scale||Standard Error|Mean
17678|NCT01827319|Secondary|2 CCS Angina Class Reduction|Canadian Cardiovascular Society (CCS) Angina Class-Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.|30 days|||participants|||Number
17679|NCT01827319|Secondary|Major Adverse Cardiovascular Events (MACE) Rate, Defined as the Incidence of Cardiac-related Death, Myocardial Infarction (Q-wave and Non Q-wave), Congestive Heart Failure, Cerebrovascular Accident, and Serious Arrhythmia||30 days|||participants|||Number
17680|NCT01827319|Primary|All Cause Mortality|Number of Participant Deaths|30 days|||participants|||Number
17681|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|4 weeks|||units on a scale, from 0 to 10||Full Range|Mean
17682|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|4 weeks|||units on a scale||Full Range|Mean
17683|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|2 weeks|||units on a scale||Full Range|Mean
17684|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|2 weeks|||units on a scale||Full Range|Mean
17685|NCT01827254|Primary|Progression Free Survival: Third Line Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 23.7 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."||months||95% Confidence Interval|Median
17686|NCT01827254|Primary|Progression Free Survival: Second Line of Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 22.9 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."||months||95% Confidence Interval|Median
17980|NCT01818700|Secondary|Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline.|EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable).|8 week|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects were assessed EQ-VAS at visit 1(baseline), 153 Subjects were assessed EQ-VAS at visit 4(8week)||units on a scale||Standard Deviation|Mean
17687|NCT01827254|Primary|Progression Free Survival for Re-challenge With Sunitinib|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 52.2 months|Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure.||months||95% Confidence Interval|Median
17688|NCT01827254|Other Pre-specified|Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 24 months|Evaluable population: All participants included in the analysis.||participants|||Number
17689|NCT01827254|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.|Baseline up to 98.0 months|Evaluable population: All participants included in the analysis.||percentage of participants||95% Confidence Interval|Number
17690|NCT01827254|Secondary|Overall Survival|Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death – Start date of treatment) + 1)/365.25 x 12.|Baseline up to death or end of study (up to 98.0 months)|Evaluable population: All participants included in the analysis.||months||95% Confidence Interval|Median
17691|NCT01827254|Primary|Progression Free Survival With Sunitinib as First Line of Therapy|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 66.6 months|Evaluable population: All participants included in the analysis.||months||95% Confidence Interval|Median
17692|NCT01826981|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
17693|NCT01826981|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
17694|NCT01826981|Secondary|For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)||Posttreatment Weeks 16 and 20|Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.||percentage of participants|||Number
17695|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)||Posttreatment Weeks 2, 4, 8, and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
17696|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 16, 20, and 24|Full Analysis Set||percentage of participants|||Number
17697|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
17698|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 10|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
17699|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
17700|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 1 and 2|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
17701|NCT01826981|Primary|Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)||Up to 24 weeks plus 30 days|Safety Analysis Set||Percentage of participants|||Number
17702|NCT01826981|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full analysis set: Participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
17703|NCT01826812|Secondary|Cytokines|Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls and the effect of sustained reading to the levels of these cytokines.|30 minutes||06/2016||||
17704|NCT01826812|Secondary|Change in Visual Acuity||30 minutes|||logMAR||Standard Deviation|Mean
17705|NCT01826812|Secondary|Change in Tear Osmolarity||Before and after 30 minutes reading|||mOsm/L||Standard Deviation|Mean
17706|NCT01826812|Secondary|Change in Total Ocular Staining Score (OSS)|Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.|Before and after 30 minutes reading|||units on a scale||Standard Deviation|Mean
17707|NCT01826812|Primary|Sustained Silent Reading Speed||30 minutes|||words/minute||Standard Deviation|Mean
17708|NCT01826604|Secondary|Secondary Outcomes Will Include the Differences Between the Two Groups.|Secondary outcomes will include the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rates between the two groups.|From the time of surgery to 30 days post-op.|infection during 30 day postoperative period||participants|||Number
17709|NCT01826604|Primary|Wound Infection or Disruption|We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.|Time of surgery to 30 days post op|Any SSI or wound disruption during 30 day postoperative period||participants|||Number
17710|NCT01826370|Secondary|Change From Baseline to Week 24 of Fasting Blood Sugar|Change from baseline to week 24 of fasting blood sugar|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for fasting blood sugar.||mg/dl||Standard Deviation|Mean
17711|NCT01826370|Secondary|Change From Baseline to Week 24 of HbA1c|Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for HbA1c.||percentage of HbA1c||Standard Deviation|Mean
17712|NCT01826370|Primary|Frequency of Adverse Events and Serious Adverse Events|Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.|Week 24|Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.||percentage of participants|||Number
17713|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-24h|AUC0-24 is the area under the concentration-time curve from time zero to 24 hours done only on 800 mg once a day schedule. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-24h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||ng*hr/mL||Standard Deviation|Mean
17714|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-8h|AUC0-8h is the area under the concentration-time curve from time zero to 8 hours. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-8h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||ng*hr/mL||Standard Deviation|Mean
17715|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Tmax|Tmax is the time to reach Cmax. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. Tmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||hr||Inter-Quartile Range|Median
17716|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Cmax|Cmax is the maximum observed plasma concentration after drug administration.The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the pharmacokineticist. Cmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1, Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.||ng/mL||Standard Deviation|Mean
17717|NCT01826214|Secondary|Overall Response Rate (ORR)|ORR was the rate of complete remission (CR), complete remission with incomplete blood count recovery (CRi) or partial response (PR) according to IWG criteria. CR, CRi or PR will be assessed through bone marrow biopsy/aspirate and peripheral blood blasts counts.|Every 8 weeks for the first 6 months and every 12 weeks until 53 weeks after the last patient is enrolled or until relapse up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."||Participants|||Number
18115|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - IgG|Summary of trough total IgG concentration prior to specified infusion|Up to 1 year|||mg/dL||Standard Error|Mean
17718|NCT01826214|Primary|Complete Remission With Incomplete Blood Count Recovery (CRi)|The other primary efficacy endpoint was CRi based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CRi. A treatment cycle was defined as 4 weeks. No statistical analysis was planned for this primary outcome.|within 3 days after clearance of blasts from peripheral blood (PB), monthly thereafter until CR or reappearance of blasts in the PB, after CR every other month until discontination up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."||Participants|||Number
17719|NCT01826214|Primary|Rate of Complete Remission (CR)|Complete Response (CR) was based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CR. A treatment cycle was defined as 4 weeks. The outcome measure for the study is based on standardized response criteria as defined by the International Working Group (IWG) for AML. The IWG was established by a group of investigators interested in the design and conduct of clinical trials in acute myeloid leukemia (AML). The criteria established by this group (a set of recommendations for response assessment) are well established, endorsed by major institutions and Health Authorities, and are widely used in clinical trials. No statistical analysis was planned for this primary outcome.|at screening, every week up to Week 9, every 2 weeks thereafter until CR, every 4 weeks after CR up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized. No statistical analysis were reported in this study."||Participants|||Number
17720|NCT01826201|Secondary|Safety Assessment|Safety will be assessed based on reported adverse events, physical examination, vital signs, electrocardiograms, hematology, serum chemistry and urinalysis. Adverse events will be reported throughout the trial. Vital signs will be performed at screening, baseline, prior to the morning dose on Days 0, 1, 7, 14, 28, and at the follow up visit on Day 42. Physical examinations will be performed at Screening, baseline and Day 28. Hematology, serum chemistry and urinalysis will be performed at screening, baseline, Days 1, 7, 14, 28, and at the follow up visit on Day 42. ECGs will be performed at Screening, baseline and Day 28.|Baseline and Day 28||||||
17721|NCT01826201|Secondary|Change in EIS Area|Change in Erythema, Induration and Scale (EIS) area. Total score will be the EIS x Area, and will be calculated at baseline, Day 7, Day 14 and Day 28. The EIS will represent the sum of individual scores of Erythema, Induration and Scale using the same scale utilized in the PSS. The area of active erythema, induration and scale will be measured and the total scores will be calculated from the EIS scores multiplied by the area in cm2.|Baseline and Day 28||||||
17722|NCT01826201|Secondary|Treatment Success|Percent of patients achieving treatment success in the treatment group compared to the placebo group on day 28. Treatment success is defined as patient achieving a psoriasis severity score (PSS) of 3 or less, or an improvement of 5 points or more on the PSS.|Baseline and Day 28||||||
17723|NCT01826201|Secondary|Physician's Treatment Preference|The physician's treatment preference utilizing visual assessment and selection of the most improved plaque. The determination will be either 1)right lesion is preferred compared to left, 2)left lesion is preferred compared to right, 3) no difference between the right and left lesion.|Day 7, Day 14, Day 28|Per protocol||participants|Participants||Number
17724|NCT01826201|Secondary|Improvement in Lesion Appearance|Photography of the MOL4239 and placebo treated lesions will be performed at baseline, Day 7, Day 14 and Day 28 to assess for the improvement in lesion appearance after drug treatment. The assessment will be completed by a blinded panel of dermatologists experienced in the assessment of psoriasis.|Baseline and Day 28||||||
17725|NCT01826201|Primary|Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions|"he study drug application sites were scored for erythema, induration, and scale assessment using the PSS Scoring system. Psoriasis Severity Score (PSS) Erythema 0 - 4, 0 None, may have residual non-erythematous discoloration~1 Faint erythema 2 Moderate erythema/red color 3 Severe erythema/very red discoloration 4 Very severe erythema/extreme red coloration Induration 0 - 4 0 None~Trace or slight elevation of plaque above normal skin level~Moderate elevation with rounded or sloped edges to plaque~Marked elevation with hard, sharp edges to plaque~Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4~0 None~Fine scales~Coarse scales~Thick scales with a rough surface~Thick scales with a very rough surface~The scores were summed"|Baseline and Day 28|||PSS score|Participants|Standard Deviation|Mean
17726|NCT01825837|Primary|Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)|The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change. The concept of improvement refers to the clinical distance between the individual’s current condition and that prior to the start of treatment. The scale for ‘severity of illness’ measures mania, depression and overall illness on a 7 point scale from 1 (‘normal, not ill’) to 7 (‘very severely ill’). The scale for ‘change from preceding phase’ and ‘change from worst phase’ measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 (‘not applicable’). If the patient, in ‘change from preceding phase’, at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.|6 months|||participants|||Number
17727|NCT01825577|Secondary|POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.|Performance Oriented Mobility Assessment (POMA), used to measure subject's ability to maintain balance. The test takes 10-15 minutes and involves asking subject to stand from a sitting position, standing with eyes closed and sitting down. POMA total score has a range of 0-36 where higher scores represent better performance. POMA total score is an additive combination of the 12 point Gait sub-score and the 16 point balance sub-score. A cut-off score of <21 is generally considered a fall risk among elderly people.|4 weeks|Elderly patients living in community nursing homes identified as fall risk with a diagnosis of probable Alzheimer's Disease.||Units on a scale||Standard Deviation|Mean
18571|NCT01807624|Primary|Tmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||minutes||Standard Deviation|Mean
17729|NCT01825200|Secondary|Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety|Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
17730|NCT01825200|Secondary|Number of Participants With Local and Systemic Events Reported as a Measure of Safety|Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
17731|NCT01825200|Secondary|Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration|Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
17732|NCT01825200|Primary|Number of Participants With Common Hypersensitivity Reactions as Measure of Safety|Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.||participants|||Number
17733|NCT01825122|Primary|Change From Baseline in the Average Number of Cigarettes Smoked Per Day||Baseline to end of treatment, up to 15 weeks|The analysis population reflects all patients who achieved maintenance dosing, including those who did not complete the study||participants|||Number
17734|NCT01824901|Primary|Maximum Tolerated Dose (MTD) of FGFR Inhibitor AZD4547|A total of 3 dose levels of AZD4547 were planned: 40mg (level 1), 60mg (level 2), and 80mg (level 3) in combination with a standard dose of docetaxel (75mg/m^2). The starting dose level of AZD4547 was 40 mg. This portion of the study used a standard 3+3 design with patients enrolled in cohorts of 3. The plan was to recommend the maximum tolerated dose (MTD) as the dose level to be used in the phase II portion of the study. MTD is defined as the highest dose level at which less than or equal to 1 of 6 subjects experience dose limiting toxicity (DLT).|Assessed during cycle 1 (21 days)|||mg|||Number
17735|NCT01824823|Primary|Disease-free Survival (DFS)|DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.|Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration|All randomized patients||months||95% Confidence Interval|Median
17736|NCT01823653|Secondary|Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement|"Mean Investigator improvement at 12 weeks using the GAIS Scale.~*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol||units on a scale||Standard Deviation|Mean
17737|NCT01823653|Secondary|Subcutaneous Adipose Thickness|Ultrasound assisted measurement of adipose tissue thickness|12 weeks||||||
17738|NCT01823653|Secondary|Safety Assessment|Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.|1, 4, 8, 12 weeks||||||
17739|NCT01823653|Secondary|Patient Satisfaction Using 1-5 Likert Scale|Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below|12 weeks|Per protocol||percentage of subjects satisfied|||Number
17740|NCT01823653|Secondary|Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator|"Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment.~*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol||Percentage of subjects improved|||Number
17741|NCT01823653|Primary|Clinical Improvement in Thigh Circumference|Clinical improvement measured by change from baseline thigh circumference after treatment|12 weeks (minus baseline)|Per Protocol||centimeter||Standard Error|Least Squares Mean
17742|NCT01823614|Other Pre-specified|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients||24 weeks|||participants|||Number
17743|NCT01823614|Secondary|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count||24 weeks|||participants|||Number
17744|NCT01823614|Primary|Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia||24 weeks|||participants|||Number
17773|NCT01824355|Secondary|Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff|Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|one hour|220 Blood Glucose results were analyzed. Study Staff provided 2 Blood Glucose Test Results from each subject who completed (110 subjects) the study.||percentage of Blood Glucose Results|Participants||Number
18572|NCT01807624|Primary|Cmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||ng/mL||Standard Deviation|Mean
17745|NCT01824602|Primary|Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 – 60) based on the patient’s subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population of 37 patients consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).||units on a scale||Standard Error|Mean
17746|NCT01824589|Secondary|Arterial Blood Gases (PaCO2)|Arterial blood gases will be collected.|15 minutes after device activation|||mmHg|||Number
17747|NCT01824589|Secondary|Lung Compliance|Change in lung compliance following each ITPR treatment compared to baseline.|baseline and immediately after device removal|||ml/cmH2O|||Number
17748|NCT01824589|Secondary|Cerebral Perfusion Pressure (CPP)|Measurement of the difference between baseline CPP and CPP at 15 minutes|15 minutes after device activation|||mmHg|||Number
17749|NCT01824589|Primary|Intracranial Pressure (ICP)|Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.|15 minutes after device is activated|||mmHg|||Number
17750|NCT01824498|Primary|E2|Estradiol|8 weeks|||pmol/L||Standard Error|Least Squares Mean
17751|NCT01824498|Primary|Plasma Sex Hormone Levels||8 weeks||||||
17752|NCT01824446|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||percentage of radioactivity||Standard Deviation|Mean
17753|NCT01824446|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||percentage of radioactivity||Standard Deviation|Mean
17754|NCT01824446|Primary|Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||Liters||Standard Deviation|Mean
17755|NCT01824446|Primary|CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS||L/hr||Standard Deviation|Mean
17756|NCT01824446|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Standard Deviation|Mean
17757|NCT01824446|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Full Range|Median
17758|NCT01824446|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents/ml||Standard Deviation|Mean
17759|NCT01824446|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents*hr/ml||Standard Deviation|Mean
17760|NCT01824446|Primary|Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||Liters||Standard Deviation|Mean
17761|NCT01824446|Primary|CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS||L/hr||Standard Deviation|Mean
17762|NCT01824446|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Standard Deviation|Mean
17763|NCT01824446|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||hours||Full Range|Median
17764|NCT01824446|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents/ml||Standard Deviation|Mean
17765|NCT01824446|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS||ng equivalents*hr/g||Standard Deviation|Mean
17766|NCT01824446|Primary|Volume of Distribution (Vz/F) of Radiolabelled SSP-004184|The distribution of a medication between plasma and the rest of the body.|Up to 288 hours post-dose|PAS||Liters||Standard Deviation|Mean
17767|NCT01824446|Primary|Total Body Clearance (CL/F) of Radio-Labelled SSP-004184|The rate at which a drug is removed from the body.|Up to 288 hours post-dose|PAS||L/hr||Standard Deviation|Mean
17768|NCT01824446|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Up to 288 hours post-dose|PAS||hours||Standard Deviation|Mean
17769|NCT01824446|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Up to 288 hours post-dose|PAS||hours||Full Range|Median
17770|NCT01824446|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 288 hours post-dose|PAS||ng/ml||Standard Deviation|Mean
17771|NCT01824446|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 288 hours post-dose|The Pharmacokinetic Analysis Set (PAS) was defined as all subjects in the Safety Analysis Set (SAS) for whom the primary pharmacokinetic data are considered sufficient and interpretable. The SAS consisted of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*hr/ml||Standard Deviation|Mean
17772|NCT01824355|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree.'|1 hour|Four subjects of those enrolled (113 subjects) had either missing or unevaluable questionnaire data.||participants|||Number
18573|NCT01807455|Secondary|Adverse Event Reporting During the Study|Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)|36 weeks|||participants|||Number
17774|NCT01824355|Secondary|Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method.|Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) and within +/- 15% (>=75mg/dL YSI capillary plasma).|1 hour|209 (220-11) Blood Glucose results were analyzed. 2 subjects had low blood sugar and per protocol their 4 AST BG results were not evaluable. 3 BG results were excluded as they were protocol deviations. One subject (2 BG results) did not complete testing within protocol timeframe and one subject (2 BG results) was unable to obtain AST blood.||percentage of AST Blood Glucose Results|Participants||Number
17775|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results <100mg/dL) and within +/- 12.5% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.||percentage of Blood Glucose Results|Participants||Number
17776|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <100mg/dL) and within +/- 15% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.||percentage of Blood Glucose Results|Participants||Number
17777|NCT01824355|Primary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.||percentage of BG results|Participants||Number
17778|NCT01824342|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); 2 = Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5 = Dead.|Baseline and Week 49|Safety analysis set with available data at both time points||participants|||Number
17779|NCT01824342|Primary|Number of Participants With Anti-denosumab Neutralizing Antibody Formation||3 years|Participants exposed to open-label denosumab with ≥ 1 antibody sample||participants|||Number
17780|NCT01824342|Primary|Percent Change From Baseline in Laboratory Values||Baseline and Week 49|Safety analysis set with available laboratory data at each time point.||percent change||Standard Deviation|Mean
17781|NCT01824342|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths|A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).|From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study.|Safety analysis set, which included participants who had properly documented informed consent for protocol 20080585 and received at least 1 dose of open-label denosumab.||participants|||Number
17782|NCT01824303|Secondary|Change From Baseline in Brief Pain Inventory (BPI)|The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
17905|NCT01821118|Secondary|Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS assessed whether participant responded yes to the following: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, self-injurious behavior with no suicidal intent."|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
17783|NCT01824303|Secondary|Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)|The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
17784|NCT01824303|Secondary|Change From Baseline in O’Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score|The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
17785|NCT01824303|Secondary|Change From Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||score on a scale||Standard Deviation|Mean
17786|NCT01824303|Secondary|Change From Baseline in Post-Void Bladder Pain|Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||units on a scale||Standard Deviation|Mean
17787|NCT01824303|Secondary|Change From Baseline in Average Void Volume Per Micturition|Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||mL||Standard Deviation|Mean
17788|NCT01824303|Secondary|Change From Baseline in Night-Time Daily Voids|Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||voids||Standard Deviation|Mean
17789|NCT01824303|Secondary|Change From Baseline in Total Daily Voids|Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.||voids||Standard Deviation|Mean
17790|NCT01824303|Primary|Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)|Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 12|Intent-to-treat (ITT) population included all randomized participants.||unit on a scale||Standard Deviation|Mean
17791|NCT01824160|Primary|Successful Repair of Conduit Disruption|"Successfully cover a tear or disruption in a RV-PA conduit wall and prevent the development of rupture or bleeding into the mediastinum during additional enlargement of the conduit. Provide persistent conduit wall integrity.~A severity of illness scale categorizes the degree of clinical illness at baseline to be compared to the remaining level of illness after placement of the Covered CP Stent (CCPS). We assess the number of participants with minimal level of illness (level 0 to 1) after CCPS placement.~0 = No injury or conduit wall disruption~= Contained disruption~= Partially contained disruption~= Uncontained conduit disruption"|Implant of Covered Stent and 6 month follow up|||participants|||Number
17792|NCT01823536|Secondary|Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal.|Day 1 to day 28|The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data.||Number of subjects|||Number
17793|NCT01823536|Secondary|Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|"The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,~Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine~Vaccine-naive subjects."|Day 1 to day 7 post-vaccination|The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data.||Number of subjects|||Number
17925|NCT01819935|Secondary|Time to Intubation|Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
17794|NCT01823536|Secondary|Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs.|Day 28 post-vaccination|The analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
17795|NCT01823536|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8.|Day 28 post-vaccination|The analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
17796|NCT01823536|Secondary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects|The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects.|5 years post-vaccination; baseline for naive|The analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
17797|NCT01823536|Secondary|Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.|The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.|5 years post-vaccination|The analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
17798|NCT01823536|Primary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine|"The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.~The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA)."|5 years post-vaccination|The analysis was done on per-protocol population i.e all subjects who provided immunogenicity data; had no major protocol deviations and who were not excluded due to other reasons defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
17799|NCT01823341|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of mornings|Participants||Number
17800|NCT01823341|Secondary|Morning Blood Ketones >=1.0 mmol/L|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of mornings|Participants||Number
17801|NCT01823341|Secondary|Percentage of Mornings With Blood Glucose >250 mg/dL (>13.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of mornings|Participants||Number
17802|NCT01823341|Secondary|Mean Morning Blood Glucose|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||mg/dL|Participants|Standard Deviation|Mean
17803|NCT01823341|Secondary|Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of time|Participants|Inter-Quartile Range|Median
17996|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
17804|NCT01823341|Secondary|Percentage of Time Overnight Sensor Glucose Values 71 to 180 mg/dL (3.9 to 10.0 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of time|Participants|Standard Deviation|Mean
17805|NCT01823341|Secondary|Mean Sensor Glucose Overnight|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||mg/dL|Participants|Standard Deviation|Mean
17806|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of nights|Participants||Number
17807|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."||percentage of nights|Participants||Number
17808|NCT01823341|Primary|Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.|"Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL (3.9 mmol/L). The time period for outcome assessment each night will be from the time the system is activated in the evening until the time it is deactivated in the morning. The percentage of hypoglycemic nights (CGM glucose value ≤70 mg/dL (3.9 mmol/L)) will be tabulated separately with versus without the closed-loop control system in use. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."||percentage of time|Participants|Inter-Quartile Range|Median
17809|NCT01823289|Primary|Number of Participants With Comprehensive Efficacy|Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.||participants|||Number
17810|NCT01823289|Primary|Number of Participants With Mycological Efficacy|Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit. Here 'N' signifies those participants who were evaluable for this measure.||participants|||Number
17811|NCT01823289|Primary|Number of Participants With Clinical Efficacy|Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.||participants|||Number
17812|NCT01823224|Secondary|Total Opioid Consumption From Time of First Waking to T24|"Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:~Opioid consumption from first waking to T4~Total opioid consumption from T0 to T4~Total opioid consumption from time of first waking to T24"|every 6 hours for 24 hours|||milligrams||Standard Deviation|Mean
17813|NCT01823224|Primary|Pain|Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.|24 hours after discharge|||NRS scale||Standard Deviation|Mean
17814|NCT01823146|Secondary|Functional Connectivity (Resting fMRI)|The functional connectivity (strength measure in units on a scale) between amygdala and medial prefrontal cortex was measured via a resting functional magnetic resonance imaging scan (participants looked at a fixation cross while images of their brain at rest were taken). Functional connectivity is the connectivity between brain regions (i.e., amygdala and medial prefrontal cortex) that share functional properties. It is defined as the temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. A mean of this correlation (connectivity strength) was computed and transformed into z-scores (r to z transformation). The z-scores ranged from -2 to +2 with higher scores representing a greater resting-state functional connectivity.|1.5 hours after oxytocin/placebo administration|All study participants who had undergone the screening as well as the full visit and had reliable resting fMRI scan data (e.g., low extent of head motion) (n = 79).||z-scores||95% Confidence Interval|Least Squares Mean
17815|NCT01823146|Secondary|Meta-Mood|Mean self-reported level of meta-mood for the two subscales attention to feelings and clarity of feelings. Response scale ranged from 1 to 5, with higher scores indicating more attention to feelings and greater clarity of feelings, respectively. The mean score for the subscales were calculated.|2.5 hours after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).||units on a scale||Standard Error|Mean
17816|NCT01823146|Primary|Extent of Trust Behavior|"Average amount of monetary units invested in the context of the Trust/Lottery Game.~The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately."|45 minutes after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).||monetary units||Standard Error|Mean
17817|NCT01822899|Secondary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. BL is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on Treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1values obtained 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84). Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, and day by BL and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.||Liters||Standard Error|Least Squares Mean
17818|NCT01822899|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Par. analyzed were those with data available at the presented time point but all par. without missing covariate information and with >= post BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
17819|NCT01822691|Secondary|Number of Participants With Study Treatment Related Adverse Events (AEs)|Participants with treatment emergent Other (not including serious) Adverse events.|Up to 12 months|All participants||participants|||Number
17820|NCT01822691|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Participants with treatment emergent Grade 3 or 4 SAEs according to the NCI Common Terminology Criteria for Adverse Events Version (CTCAE) V4.0.|Up to 12 months|All participants||participants|||Number
17821|NCT01822691|Secondary|Median Overall Survival (OS)|Overall Survival (OS) defined as the time between the start of treatment and death. Treatment Duration is 17 weeks plus optional continuation phase. Study Duration is Treatment Phase followed by survival follow-up.|Up to 24 months|All participants||months||Full Range|Median
17822|NCT01822691|Secondary|Mean Time to Acute Myeloid Leukemia (AML) Progression|Disease progression defined as progression to int-2 or high risk International Prognostic Scoring System (IPSS) score or AML, based on World Health Organization (WHO) AML Criteria.|Up to 12 months|All participants||months||Full Range|Mean
17823|NCT01822691|Primary|Overall Response Rate (ORR)|ORR, measured by Response Criteria for Patients with Myelodysplastic Syndrome (MDS). According International Working Group (IWG) 2006 criteria (Cheson et al, 2006). Complete Remission (CR), Partial Remission (PR), Marrow CR, and Hematological Improvement (HI)(any cell line). Stable Disease (SD): Failure to achieve at least PR, but no evidence of progression for > 8 weeks.|Up to 12 months|All participants||participants|||Number
17834|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Delayed Recall|Cognitive performance will be evaluated using the Delayed Recall obtained using the Memory section of the Montreal Cognitive Assessment (MoCA). We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Scores are based on individual performance. All subjects are asked to remember two lists of five words (one list during baseline, and one list during cool Challenge). Lower scores indicate poorer performance, and a positive percent change in indicates improved cognitive performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.||Percent Change||Standard Deviation|Mean
18574|NCT01807455|Secondary|Assessment of Local Tolerability After Treatment|Number of subjects reporting anticipated injection-related reactions after treatment|14 days|||participants|||Number
17824|NCT01822678|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score at the End of the 3-week Treatment Period, in Relation to the Baseline.|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 – 60) based on the patient’s subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
17825|NCT01822665|Secondary|Incidence of Fecal Occult Blood|The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood).|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Participants|||Number
17826|NCT01822665|Secondary|Incidence of Gastric and/or Duodenal Mucosal Injury|Number of participants with endoscopy score equal to or more than 2 were determined based on Lanza score for both gastric and duodenal mucosal damage.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Participants|||Number
17827|NCT01822665|Secondary|Duodenal Mucosal Damage (DMD) Scores|DMD was measured using a 5- point Lanza scale: 0 - normal duodenum; 1 - mucosal hemorrhages; 2 - one or two erosions; 3 - numerous areas of erosions and 4 - more than 10 erosions/ ulcers.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Score on a scale||Standard Deviation|Mean
17828|NCT01822665|Secondary|GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Score on a scale||Standard Deviation|Mean
17829|NCT01822665|Primary|Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|Intent to Treat (ITT) population: all participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.||Scores on a scale||Standard Deviation|Mean
17830|NCT01822574|Secondary|Time to Complete Patella Resurfacing|Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. After the final resection, the timer was stopped.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)|||seconds||Standard Deviation|Mean
17831|NCT01822574|Secondary|The Difference Between Surgeon Goal and Actual Resection Height|This outcome measure attempts to capture the most accurate method for obtaining a desired thickness. Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. The surgeon then stated their goal for post resection thickness, and these values were recorded. After the final resection, the timer was stopped. The ability to obtain the resection goal was independently assessed by a resident or fellow not involved in the resection. This was calculated by taking the difference between the surgeon's goal and the average thickness of the four quadrants measured by the resident or fellow.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)|||mm||Standard Deviation|Mean
17832|NCT01822574|Primary|Mean Asymmetry of the Patella After Patella Resection|"Post-resection symmetry of the patella was independently assessed by a resident or fellow who was not involved in the resection. This was evaluated by dividing the patella into four equal quadrants and measuring the thickness in the center of each quadrant using a ring tipped or C-shaped caliper. The difference between the thickest and thinnest measurements of the patella was reported as the value of asymmetry."|approximate average surgery time of 3 hours|||mm||Standard Deviation|Mean
17833|NCT01822535|Primary|Visit 2: Percent Change in Core Body Temperature With Midodrine|We will test the effects of midodrine on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) after exposure to cool temperatures (64°F) in persons with tetraplegia through comparing the percent changes in core body temperature during visit 1 to percent changes in core body temperature during visit 2.|Baseline, Baseline Post-midodrine, Up to 2 hours|Subjects analyzed were individuals who completed visit 1 of testing.||Percent Change||Standard Deviation|Mean
17842|NCT01822223|Primary|Number od Participants With Consistent Connective Tissue Integration at a Histologic Level|Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.|8 weeks post-abutment placement|The number of participants entered represents measured data.||participants|||Number
17997|NCT01818596|Secondary|Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Week 24|P1NP is a biomarker of bone turnover.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
17835|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Stroop Interference|Cognitive performance will be evaluated using the Interference T-Scores obtained using the Stroop Color and Word Test. We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.||Percent Change||Standard Deviation|Mean
17836|NCT01822535|Primary|Visit 1: Percent Change in Core Body Temperature|We will test the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) in persons with tetraplegia through comparing the percent changes in core body temperatures between groups from baseline to after cool exposure.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.||Percent Change||Standard Deviation|Mean
17837|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 month post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
17838|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|16 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
17839|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
17840|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
17841|NCT01822223|Secondary|Grams of Force Needed to Disrupt Tissue Attachment to the Abutment|A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.|||||
17844|NCT01822197|Secondary|Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)|depressive symptom scoring at day 0 and day 7 using Quick Inventory of Depressive Symptomatology-clinician (QIDS-C) and Quick Inventory of Depressive Symptomatology self-report (QIDS-SR). Day 7 and Day 0 scores will be compared. Score range is 0 to 27. A QIDS score of less than 6 indicates no depression, 6–10 indicates mild depression, 11–15 moderate, 16–20 severe, and 21– 27 very severe depression.|between day 0 and day 7 of hospitalization|||units on a scale||Standard Deviation|Mean
17845|NCT01822197|Primary|Length of Hospitalization|Length of stay will be measured in days|participants will be followed for the length of hospital stay, an average of 14 days|||days||Standard Deviation|Mean
17846|NCT01822119|Other Pre-specified|Safety; Numbness|Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||participants|||Number
17847|NCT01822119|Other Pre-specified|Safety; Pain|Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
17848|NCT01822119|Other Pre-specified|Safety; Skin Evaluation|Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
17849|NCT01822119|Other Pre-specified|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|Week 4, 6, 12 and 36|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||Newton||Standard Deviation|Mean
17850|NCT01822119|Other Pre-specified|Feedback Measurement, BP110|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
17851|NCT01822119|Other Pre-specified|Feedback Measurement, BP100|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
17852|NCT01822119|Other Pre-specified|Choice of Sound Processor|Type of sound processors BP100 and BP110 attached to a soft band (subject preference)|Baseline|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||participants|||Number
17853|NCT01822119|Other Pre-specified|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.|Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
17854|NCT01822119|Other Pre-specified|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.|Visit 2 (surgery)|Intention-to-Treat population, includes all patients who received surgical intervention.||participants|||Number
17855|NCT01822119|Other Pre-specified|Time to Perform Surgery||Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||minutes||Standard Deviation|Mean
17856|NCT01822119|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||units on a scale||Standard Deviation|Mean
17857|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||Signal to noise ratio||Standard Deviation|Mean
17858|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||Signal to noise ratio||Standard Deviation|Mean
17859|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||% perception of presented words||Standard Deviation|Mean
18990|NCT01796548|Secondary|Reflex Volume|Reflex volume is the infused volume that induces the first detrusor contraction.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).|||||
17861|NCT01822119|Secondary|Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
17862|NCT01822119|Secondary|Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
17863|NCT01822119|Secondary|Hearing Performance, Individual Frequencies|The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
17864|NCT01822119|Primary|Hearing Performance, PTA4 at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|||dB||Standard Deviation|Mean
17865|NCT01822119|Primary|Hearing Performance, PTA4 at 12 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.||dB||Standard Deviation|Mean
17866|NCT01821963|Secondary|Sustained Virological Response (SVR)|Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation. The treatment duration will be summarized with descriptive statistics. Additional analyses based on evaluable patients also conducted regarding the PTVR response rate. The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement. The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV. The SVR rate will be estimated, along with the exact 95% confident interval.|60 weeks||||||
17867|NCT01821963|Primary|Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant|"The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant.~Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate."|12 weeks post-transplant, up to 48 weeks for overall monitoring|Study terminated early with one participant. No analysis possible.|||||
17868|NCT01821937|Secondary|Tmax,ss (After Multiple Dosing)|tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||hour||Geometric Coefficient of Variation|Geometric Mean
17869|NCT01821937|Secondary|t(1/2,ss) (After Multiple Dosing)|t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||hour||Geometric Coefficient of Variation|Geometric Mean
17870|NCT01821937|Secondary|AUC(0-tz) (After Single Dosing)|AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
17871|NCT01821937|Secondary|Cmax (After Single Dosing)|Cmax is defined as maximum measured concentration of Faldaprevir in plasma.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17872|NCT01821937|Primary|AUC(Tau,ss) (After Multiple Dosing)|AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
17873|NCT01821937|Primary|Cmax,ss (After Multiple Dosing)|C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .||ng/mL||Geometric Coefficient of Variation|Geometric Mean
17874|NCT01821859|Primary|Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease.|Using RECIST criteria, Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease.|6 months after start of dosing||||||
17875|NCT01821807|Secondary|Backache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of postdural puncture backache for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week|||participants|||Number
17876|NCT01821807|Primary|Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of headache (PDPH) for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week|||participants|||Number
17877|NCT01821534|Primary|Intra-rater Reliability Using a LFSC|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kappa statistics||95% Confidence Interval|Number
17878|NCT01821534|Primary|Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kappa Statistics||95% Confidence Interval|Number
17879|NCT01821534|Primary|Intra-rater Reliability Using a MMPS|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kappa statistics||95% Confidence Interval|Number
17880|NCT01821534|Primary|Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall’s coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1||Kendall's W||95% Confidence Interval|Number
17881|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score|"The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.~Reason for the discrepancy of the LS mean (SE) for placebo in outcome 2 and outcome 9 is because the different MMRM model used in outcome 2 and outcome 9. The treatment groups included in the MMRM model for outcome 2 are placebo, lurasidone 20 mg, and lurasidone 80-160 mg. The treatment groups included in the MMRM model for outcome 9 are placebo, ENR lurasidone 80 mg, and ENR lurasidone 160 mg."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).||units on a scale||Standard Error|Least Squares Mean
17998|NCT01818596|Secondary|Percent Change From Baseline in C-type Collagen Sequence (CTX) at Week 24|CTX is a biomarker of bone turnover.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
17882|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).||units on a scale||Standard Error|Least Squares Mean
17883|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the Euroqol (EQ-5D) Index Score|The EQ-5D is a standardized measure of health state consisting of two parts: a) EQ-5D measuring mobility, self-care, pain/discomfort, usual activities, and anxiety/depression on a 0 2 scale with lower scores indicating improvement, and b) a 20-cm visual analogue scale (VAS) for health status rating on a 0-100 scale with higher scores indicating improvement. EQ-5D health states, defined by the EQ-5D descriptive system, may be converted into a single summary index (i.e. the EQ-5D index score) by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The EQ-5D Index scores ranged from -0.429 to 1.000. Generally higher observed EQ-5D Index scores indicate a better degree of health.|6 weeks|Intent to treat population: there are only 368 subjects who had at least one post-baseline Euroqol (EQ-5D) assessments.||units on a scale||Standard Error|Least Squares Mean
17884|NCT01821378|Secondary|Change From Week 2 to Week 6 for ENR Lurasidone 80 mg vs. ENR Lurasidone 160 mg in CGI-S Score|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|week 2 to week 6|ENR Intent to treat population||units on a scale||Standard Error|Least Squares Mean
17885|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the GAF Score|The GAF is a numeric scale (0 through 100) that measures a patient’s overall level of psychological, social, and occupation functioning. It is designed to guide clinicians through a methodical and comprehensive consideration of all aspects of a patient’s symptoms and functioning. The scale begins at 100 - superior functioning - to 0 - inadequate information.|6 Weeks|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
17886|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the MADRS Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).||units on a scale||Standard Error|Least Squares Mean
17887|NCT01821378|Secondary|Change From Week 2 to Week 6 for the ENR (Early Non-responders) Lurasidone 160mg Group vs the ENR (Early Non-responders) Lurasidone 80 mg Group in the Following: PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|week 2 to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population.||units on a scale||Standard Error|Least Squares Mean
17888|NCT01821378|Secondary|Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Score (PANSS) Total Score at Week 6|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|6 Weeks|Intent to treat population||percentage of participants|||Number
17889|NCT01821378|Secondary|Change From Baseline to Week 6 for the Lurasidone 20 mg, and Lurasidone 80 - 160 mg Groups Versus the Placebo Group in the Montgomery-Asberg Depression Rating Scale Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|Baseline to 6 Weeks|Intent to treat population - only 379 subjects had at least one post-baseline MADRS assessment.||units on a scale||Standard Error|Least Squares Mean
17890|NCT01821378|Secondary|Change in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|Baseline to 6 Weeks|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
17891|NCT01821378|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to 6 Weeks|Intent to treat population - there was one subject randomized but not treated with study medication, therefore excluded from ITT population||units on a scale||Standard Error|Least Squares Mean
17892|NCT01821352|Primary|Change in Combined Circumference Measurement|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total combined body circumference measurement. Change in combined circumference measurement is calculated as the difference in circumference measurements from baseline to endpoint (4 weeks). A negative (-) change indicates a decrease in circumference and is positive for study success. A positive (+) change indicates an increase in circumference and is negative for study success.|Baseline and 4 Weeks|||inches||Standard Deviation|Mean
17893|NCT01821352|Other Pre-specified|Subject Satisfaction With Procedure Outcome|"Subjects rated satisfaction with the outcome of the study procedures with respect to change in body shape on the following 5-point scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Not Very Satisfied, Not at All Satisfied.~Results are reported as the number of subjects in each treatment group who rated study outcome satisfaction as 'Very Satisfied' or 'Somewhat Satisfied'."|4 Weeks|||participants|||Number
17894|NCT01821352|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total body circumference measurement. Change in combined circumference measurement from baseline to 4 weeks was calculated for each subject. Individual subject success was defined as a change of 3.0 inches or more in the combined circumference measurement across the evaluation period. A decrease in combined circumference measurement is positive for individual subject success. An increase in combined circumference measurement is negative for individual subject success. Overall study success was defined as a 40% or greater difference between the proportion of individual successes in each treatment group.|Baseline and 4 Weeks|||participants|||Number
17895|NCT01821326|Primary|Rebleeding Rate||10 years|||participants|||Number
17896|NCT01820364|Secondary|Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways|Molecular status was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline and at progression with LGX818 single agent treatment||||||
17897|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study."|Entry to Part II of the study through study completion (approximately 22 days)|This analysis group is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.||participants|||Number
17898|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through completion of Part I of the study (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.||participants|||Number
17899|NCT01820364|Secondary|Plasma Concentration and Derived Pharmacokinetic Parameters|Assessment of pharmacokinetic (PK) parameters and plasma concentration was not done due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)||||||
17900|NCT01820364|Secondary|Incidence of Dose Limiting Toxicities (DLTs) (Part II)|Incidence of DLTs in Part II of the study was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)||||||
17901|NCT01820364|Primary|Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through study completion (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.||participants|||Number
17902|NCT01821118|Secondary|Number of Participants With Anti-PF-04360365 Antibodies|Blood samples were collected from participants who received active treatment to assess for presence/absence of anti-PF-04360365 antibodies.|Day 1 up to Day 240|All 24 participants who received PF-04360365 were included in this analysis.||participants|||Number
17903|NCT01821118|Secondary|Number of Participants With Significant Changes in Neurological Examination Results|A complete/full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station.|Baseline up till Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
17904|NCT01821118|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination at Final Visit|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline up to Final Visit (Day 240)|All 36 participants who received study drug were included in the analysis.||participants|||Number
17906|NCT01821118|Secondary|Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or more than (>) 160 mm Hg; supine diastolic blood pressure (DBP) <50 mm Hg or >100 mm Hg; supine pulse rate of <60 beats per minute (bpm) or >100 bpm; maximum changes (increase or decrease) from baseline in supine SBP of >=20 mm Hg; maximum increase from baseline in supine DBP of >=20 mm Hg; and maximum decrease from baseline in supine DBP of >=10 mm Hg.|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
17907|NCT01821118|Secondary|Number of Participants With Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function (including Hy's Law Criteria), renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.||participants|||Number
17908|NCT01821118|Secondary|Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to Day 240|All 36 participants who received study drug were included in the AE summarization/analysis.||participants|||Number
17909|NCT01821118|Secondary|Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time|The Montreal Cognitive Assessment (MoCA) was used as a safety outcome measure to assess any changes in cognition. The MoCA is a 1-page 30-point test administered in approximately 10 minutes. The MoCA assessed short term memory, visuospatial abilities, multiple aspects of executive functions, attention, concentration, working memory, and language, as well as orientation to time and place. A score of more than or equal to (>=) 26 to 30 (maximum possible point) is considered as normal. An average of 22 points is considered as mild cognitive impairment. Lower scores indicate decreasing cognitive function.|Screening; Days 0, 1, 30, 60, 90, and 240|All 36 participants who received study treatment were included in the analysis. On Day 240, the number of evaluable participants in the placebo group was 11 instead of 12.||units on a scale||Standard Deviation|Mean
17910|NCT01821118|Secondary|Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities|"Brain sMRI abnormalities included cerebral edema and total infarcts (including cortical infarcts, white matter infarcts, and subcortical gray matter infarcts). Total infarcts is the total number of participants with at least 1 type of infarct."|Baseline/Screening, Day 15, Day 45, Day 90,|All 36 participants who received study treatment were analyzed for this endpoint.||participants|||Number
17911|NCT01821118|Secondary|Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)|Cerebral amyloid angiopathy (CAA) is caused by the progressive deposition of amyloid, predominantly AB40, within the walls of cerebral blood vessels with a predisposition for the vessels of the occipital lobe. As such, it is of interest to investigate the effect of PF-04360365 on AB concentrations. AB1-x and AB1-40 were investigated.|Day 1 (pre dose and 8 hours post dose), Day 2, Day 30, Day 90, Day 240|All 36 participants who received study treatment were included in this pharmacodynamic analysis. n=number of participants with measurable AB at the specified time point.||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
17912|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.||seconds||90% Confidence Interval|Least Squares Mean
17913|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.||percent||90% Confidence Interval|Least Squares Mean
17926|NCT01819935|Secondary|Time to Transfer Out From the Intensive Care Unit (ICU)|Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
17927|NCT01819935|Secondary|Time to Discharge From the Hospital|Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Standard Deviation|Mean
17914|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.||seconds||Standard Error|Geometric Mean
17915|NCT01821118|Primary|Change From Baseline to Day 90 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at Day 90.||percent/second||Standard Error|Geometric Mean
17916|NCT01821118|Primary|Change From Baseline to Day 2 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked Functional Magnetic Resonance Imaging (fMRI)|Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.|Baseline, Day 2|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified region of interest (ROI) at Day 2.||percent/second||Standard Error|Geometric Mean
17917|NCT01821105|Secondary|Tumor Detection||At surgery|||lesions detected|||Number
17918|NCT01821105|Secondary|All Adverse Events and Complications||up to 12 months|||patients|||Number
17919|NCT01821105|Primary|Detection of Position Accuracy With Handheld Probe on Anatomical Location.||up to 12 months|number of tumor lesions detected by the probe||lesions|Participants||Number
17920|NCT01820585|Primary|Absolute Change From Baseline to Endpoint in Mean Pain|The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject’s diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject’s diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.|Baseline and 13 Weeks|||units on a scale||Standard Error|Least Squares Mean
17921|NCT01820559|Primary|Absolute Change From Baseline in the Frequency of Migraine Attacks|The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.|4 weeks|||number of migraine attacks/participant||Standard Error|Least Squares Mean
17922|NCT01819935|Secondary|Clinical Success|Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|"FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."||percentage of participants|||Number
17923|NCT01819935|Secondary|Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection|Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
17924|NCT01819935|Secondary|Time to 30-day Re-admission|Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
17928|NCT01819935|Secondary|Time to Therapy Change|Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
17929|NCT01819935|Primary|Time to 30-day Mortality|Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.||days||Full Range|Median
17930|NCT01819922|Secondary|Plasma Metabolomic Profiles Before and Immediately Following Steady State and Incremental Exercise|Plasma metabolomic profiles before and immediately following steady state and incremental exercise were collected using vacutainer tube containing dipotassium ethylenediamine tetraacetic Acid (K2EDTA) were processed by the clinical site according to handling specifications.|1 hour pre-dose, 1 hour 20 minutes and 2 hours 10 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
17931|NCT01819922|Secondary|Peak Diastolic Untwisting Rate|Diastolic untwisting is an important component of early diastolic left ventricular filling. Left ventricular diastolic function is determined by early diastolic relaxation and myocardial stiffness. Peak diastolic untwisting rate is defined as the rate of left ventricular relaxation. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
17932|NCT01819922|Secondary|Diastolic Strain Rate|Diastolic strain rate was defined as the rate of percent change in all segments of left ventricular dimension in comparison to its original dimension. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
17933|NCT01819922|Secondary|Change From Baseline in Early and Late Peak Velocity|Tissue velocities were measured off-line from 2D color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Change from baseline in early and late peak tissue velocities were reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||cm/sec||Standard Deviation|Mean
17934|NCT01819922|Secondary|Early and Late Peak Tissue Velocity|Tissue velocities were measured off-line from two dimensional (2D) color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Early and late peak tissue velocities (EPV and LPV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||cm/sec||Standard Deviation|Mean
17935|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral doppler time was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||msec||Standard Deviation|Mean
17936|NCT01819922|Secondary|Trans-mitral Doppler: Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||msec||Standard Deviation|Mean
17937|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral ration was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||ratio||Standard Deviation|Mean
17949|NCT01819922|Secondary|Cardiac Structure: Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area (EDA) and end-systole area (ESA). It was assessed by echocardiography using 2-dimensional gray-scale imaging.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||millimetre (mm)||Standard Deviation|Mean
17938|NCT01819922|Secondary|Trans-mitral Doppler: Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."||ratio||Standard Deviation|Mean
17939|NCT01819922|Secondary|Change From Baseline in Systolic Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis. Change from baseline in systolic global strain rate was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change per second||Standard Deviation|Mean
17940|NCT01819922|Secondary|Systolic Function: Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change per second||Standard Deviation|Mean
17941|NCT01819922|Secondary|Systolic Function: Rotation/Torsion|Torsion is the twisting of an object due to an applied torque. It is expressed in newton metres. The left ventricle twists in systole storing potential energy and untwists (recoils) in diastole releasing the energy. Twist aids left ventricular ejection and untwist aids relaxation and ventricular filling. Therefore, rotation and torsion are important in cardiac mechanics. It was assessed by echocardiography using speckled tracking analysis .|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
17942|NCT01819922|Secondary|Change From Baseline in Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing). Change from baseline in peak contractile velocity was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||cm/sec||Standard Deviation|Mean
17943|NCT01819922|Secondary|Systolic Function: Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||centimeter per second (cm/sec)||Standard Deviation|Mean
17944|NCT01819922|Secondary|Change From Baseline in Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant. Change from baseline in ejection fraction was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percentage of EDV||Standard Deviation|Mean
17945|NCT01819922|Secondary|Systolic Function: Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percentage of EDV||Standard Deviation|Mean
17946|NCT01819922|Secondary|Change From Baseline in Atrial Volumes|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes and end-diastole volumes were reported. Change from baseline in atrial volume was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
17947|NCT01819922|Secondary|Cardiac Structure: Atrial Volume|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes (ESV) and end-diastole volumes (EDV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
17948|NCT01819922|Secondary|Change From Baseline in Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area and end-systole area. It was assessed by echocardiography using 2-dimensional gray-scale imaging. Change from baseline in right ventricular dimension was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mm||Standard Deviation|Mean
17973|NCT01819272|Secondary|Change in HbA1c (%) at 12 Weeks||Baseline and 12 weeks after the first dose of study medication|Week 12 Evaluable||HbA1c (%)||Standard Error|Least Squares Mean
17974|NCT01819272|Secondary|AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks||Baseline and 4 to 12 weeks after the first dose of study medication|Week 12 Evaluable||mg/dL*week||Full Range|Median
17950|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Geometry|Left ventricular geometry was assessed by echocardiography using 2-dimensional gray-scale imaging. Relative wall thickness was the index of left ventricular geometry and defined as the sum of interventricular septal thickness (mm) and posterior wall thickness (mm) divided by LV internal end-diastolic diameter (mm).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
17951|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Wall Thickness|Left ventricle is the chamber in the heart responsible for pumping blood to the rest of the body. Thickening of the lower chambers of left ventricular wall is also termed as ventricular hypertrophy. It was assessed by echocardiography using 2-dimensional gray-scale imaging; M-mode.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
17952|NCT01819922|Secondary|Change From Baseline in the Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Change from baseline in left ventricular volume was reported using modified Simpson’s technique.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
17953|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Left ventricular volume was reported using modified Simpson’s technique.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
17954|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Physical Work Capacity at a Heart Rate of 130 Beats Per Minute (PWC 130)|Physical work capacity evaluates the capacity of an individual to perform physically demanding work tasks. PWC 130 was a simple sub-max exercise parameter that can be used as surrogate for fitness that was independent of metabolic cart measurements. Interventions that improve fitness improve the PWC 130.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||bpm||Standard Deviation|Mean
17955|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Aerobic Efficiency|Aerobic efficiency was defined as volume of oxygen divided by work. This parameter was assessed during cardiovascular exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/watt||Standard Deviation|Mean
17956|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Kinetics|Oxygen kinetics describes the dependence of respiration of isolated cells on oxygen partial pressure. The characteristics of oxygen uptake kinetics differ with intensity of exercise.|1 hour 40 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.|||||
17957|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Pulse|Oxygen Pulse (VO2 /Heart Rate) was equal to stroke volume multiplied by oxygen extraction. This parameter was assessed during cardiopulmonary exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/beat||Standard Deviation|Mean
17958|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Volume of Oxygen (VO2) at Anaerobic Threshold (AT)|VO2 at anaerobic threshold was widely recognized as a sub-max indicator of fitness. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL||Standard Deviation|Mean
17959|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope was also termed as ventilator efficiency. It was defined as the amount of minute ventilation required to eliminate 1 liter of carbon dioxide. The determinants of VE/VCO2 included fractional dead space and partial pressure of carbon dioxide. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||unitless||Standard Deviation|Mean
17960|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Respiratory Exchange Ratio (RER)|RER was defined as the ratio between the amount of oxygen (O2) consumed and carbon dioxide (CO2) produced in one breath. The parameter was assessed during indirect measure of heat production (calorimetry).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||ratio||Standard Deviation|Mean
17961|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2)|VO2 was the maximum rate of oxygen consumption as measured during incremental or prolonged, sub-maximal exercise. It reflects the aerobic physical fitness of the individual. It was assessed during indirect measure of heat production (calorimetry). The unit of measure is milliliter per kilogram per minute (mL/kg/min).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/kg/min||Standard Deviation|Mean
17975|NCT01819272|Primary|Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks||Baseline and 4 weeks after the first dose of study medication|Week 4 Evaluable||mg/dL||Full Range|Median
17962|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters|Criteria for clinically significant ECG values included: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent (%) from baseline value of >200 msec and >=50 % for baseline value of <=200 msec, maximum QRS interval >=140 msec or maximum increase of >=50% for baseline value of >100 msec; QT interval corrected using the Fridericia formula (QTcF) 450-<480 msec, 480-<500, >=500 msec or increase of >45 msec or maximum increase of >=30 to <60 and >=60 msec for QT interval where, PR interval: interval between the start of the P wave and the start of the QRS complex corresponding to the time between the onset of atrial depolarization and onset of ventricular depolarization; QRS interval: time from electrocardiogram Q wave to the end of the T wave corresponding to ventricle depolarization, QTcF interval: time corresponding to the beginning of depolarization to repolarization of the ventricles.|Baseline up-to 3 hour post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
17963|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data|Participants who met the pre-defined criteria for clinically significant cardiovascular events were reported. Criteria for clinically significant cardiovascular events: Blood pressure (BP) [supine systolic and sitting systolic BP (SBP): <90 millimeter of mercury (mm Hg), >=30 mmHg maximum increase and decrease from baseline in same posture; supine diastolic and sitting diastolic BP (DBP): <50 mm Hg, >=20 mmHg maximum increase and >=30 mmHg maximum decrease from baseline in same posture]; pulse rate: supine and sitting: <40 or >120 bpm.|Baseline up-to 3 hours post-dose|"Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment. Here, n specified the number of participants who were evaluable for the specified criteria."||participants|||Number
17964|NCT01819922|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant:Hematology (hemoglobin,hematocrit,red blood corpuscles [RBC] count:less than [<]0.8*lower limit of normal [LLN];platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN];white blood corpuscles [WBC]:<0.6*LLN or >1.5*ULN;lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN;basophils,eosinophil, monocytes:>1.2*ULN);Liver Function(aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase:>0.3*ULN;total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin:>1.5*ULN);Renal Function (blood urea nitrogen,creatinine:>1.3*ULN; uric acid:>1.2*ULN);Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride, calcium,bicarbonate:<0.9*LLN or >1.1*ULN; glucose fasting:<0.6*LLN or >1.5*ULN);Urinalysis (urine pH:>1.5*ULN or >4.5;urine glucose,ketones,proteins, nitrites, leukocyte esterase,blood/hemoglobin:greater than or equal to (>=)1;urine WBC and RBC,urine bacteria:>=20/High Power Field [HPF];epithelial cells:>=6/HPF).|Baseline up-to 3 hours post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
17965|NCT01819922|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. Treatment-emergent were events between first dose of study drug and up to 5-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 5-10 days after last dose of study drug (up to 25 days)|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.||participants|||Number
17966|NCT01819922|Primary|Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose|OUES was defined as an index of cardiopulmonary functional reserve that was based upon a submaximal exercise effort. OUES relates oxygen uptake to total ventilation during exercise.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||mL/log10(L)||Standard Deviation|Mean
17967|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change||Standard Deviation|Mean
17968|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|1 hour 30 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.||percent change||Standard Deviation|Mean
17969|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose|Full analysis set (FAS) was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 pharmacodynamic (PD) measurement.||percent change||Standard Deviation|Mean
17970|NCT01819415|Secondary|Central Foveal Thickness|Measured with spectral-domain optical coherence tomography.|During at least 12 months of follow-up after vitreous biopsy.||||||
17971|NCT01819415|Primary|Lipidomics Profile||1 day (At the time of vitreous biopsy)||||||
17972|NCT01819415|Primary|Vitreal VEGF Levels.||1 day (At the time of vitreous biopsy)|||pg/ml|||Number
17981|NCT01818700|Secondary|Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline|"The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.~EQ-5D score = 1 - 0.081 - (relevant score by level for the relevant item)-0.269 (only if there is at least one level 3).~Table of scores by level for EQ-5D items mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.236)."|8 weeks|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects at Visit 1, baseline were assessed EQ-5D questionnaire, At visit 4(8weeks), 153 subjects were assessed EQ-5D questionnaire.||units on a scale||Standard Deviation|Mean
17982|NCT01818700|Secondary|Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline.|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 4/ET minus mean score at Baseline.|4 weeks|FAS set: 210. Missing values were imputed LOCF.||units on a scale||Standard Deviation|Mean
17983|NCT01818700|Primary|Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 8/ET minus mean score at Baseline.|8 weeks|FAS set: 210. Missing values were imputed by LOCF FAS included the data obtained from all subjects who had at least one dose of the study drug and had data of at least one primary efficacy endpoint assessment.||units on a scale||Standard Deviation|Mean
17984|NCT01818596|Secondary|PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study|TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide. AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants who were enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom the steady-state PK parameter (AUCtau) of TFV-DP was evaluable were analyzed.||µmol*h/L||Standard Deviation|Mean
17985|NCT01818596|Secondary|PK Parameter: t1/2 of TAF|t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||hours||Inter-Quartile Range|Median
17986|NCT01818596|Secondary|PK Parameter: AUCtau of TAF|AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||ng*h/mL||Standard Deviation|Mean
17987|NCT01818596|Secondary|PK Parameter: λz of TAF|λz is defined as the terminal elimination rate constant. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||1/hour||Standard Deviation|Mean
17988|NCT01818596|Secondary|PK Parameter: Tlast of TAF|Tlast is defined as the time of Clast. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||hours||Inter-Quartile Range|Median
17989|NCT01818596|Secondary|PK Parameter: Clast of TAF|Clast is defined as the last observable concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||ng/mL||Standard Deviation|Mean
17990|NCT01818596|Secondary|PK Parameter: Tmax of TAF|Tmax is defined as the time of Cmax. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.||hours||Inter-Quartile Range|Median
17991|NCT01818596|Secondary|Pharmacokinetic (PK) Parameter: Cmax of TAF|Cmax is defined as the maximum concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set (enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom steady-state PK parameters were available) with available data were analyzed.||ng/mL||Standard Deviation|Mean
17992|NCT01818596|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
17993|NCT01818596|Secondary|Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities|"Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.~Data were collected for all participants through the Week 24 visit; additional data are included for participants who had passed the Week 24 visit."|Baseline to Week 24 Data Cut (average 42 weeks)|Safety Analysis Set||percentage of participants|||Number
17994|NCT01818596|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Week 24|Urine beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
17995|NCT01818596|Secondary|Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Week 24|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||percentage change||Inter-Quartile Range|Median
17999|NCT01818596|Secondary|Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy|aGFR was directly measured using iohexol plasma clearance (CLiohexol).|Baseline; Week 2, 4, or 8; Week 24|Participants in the Pharmacodynamic (PD) Substudy Analysis Set (enrolled in the pharmacokinetic (PK)/PD substudy, received at least 1 dose of study drug, and had baseline and at least 1 postbaseline assessment for aGFR assessed by CLiohexol) with available data at the respective time point were analyzed.||mL/min||Standard Deviation|Mean
18000|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
18001|NCT01818596|Primary|Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24|eGFR is a measurement of the kidney's ability to filter blood.|Baseline; Week 24|Participants in the Safety Analysis Set (enrolled and received at least 1 dose of study drug) with available data at the respective time point were analyzed.||mL/min||Inter-Quartile Range|Median
18002|NCT01818414|Secondary|Complications|Incidence of surgical complications related to D&E|Day 1|||participants|||Number
18003|NCT01818414|Secondary|Number of Providers With Overall Satisfaction|Provider overall satisfaction with cervical preparation|Day 1|||providers|||Number
18004|NCT01818414|Secondary|Number of Participants With Postoperative Satisfaction|Patient postoperative satisfaction with cervical preparation method|Day 1|||participants|||Number
18005|NCT01818414|Secondary|Patient Pain|"Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale (100-mm Visual Analogue Scale with 0 indicating no pain and 100 indicating worst pain in my life)"|Day 1|||100 mm visual analog scale||Standard Deviation|Mean
18006|NCT01818414|Primary|Operative Time|The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E.|Day 1 of the study|||minutes||Standard Deviation|Mean
18007|NCT01818336|Primary|Negative Predictive Value|The primary endpoint was the negative predictive value (NPV), which was estimated as p = percentage of n history-positive subjects with negative skin tests from the Penicillin Allergy Skin Test Kit (as confirmed with an overall negative result for the skin puncture/intradermal testing) who do not experience an IgE-dependent hypersensitivity reaction within 72 hours of the oral amoxicillin challenge.|72 hours|The Intent-to-Treat Population; all subjects with valid skin testing performed (ie, administered all components of the penicillin skin test kit and the histamine/control results were valid), who had negative intradermal skin tests with all 3 Kit reagents, and who received the oral amoxicillin challenge||percentage of participants||95% Confidence Interval|Number
18008|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmin)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
18009|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmax)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
18010|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (AUC(0-tau) )|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9.~*AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours .~Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
18011|NCT01817855|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)|Up to 24 days|||Participants|||Number
18012|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Other Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|"All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of other symptoms, data of one participant each from the two groups are unavailable."||Score on a scale||Standard Deviation|Mean
18042|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Confusion Assessment Method (CAM) Diagnostic Algorithm. This binary tool identifies the presence or absence of delirium|Postoperative day 2|||participants|||Number
18064|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 15|Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 15|Intent-to-treat (ITT) population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
18013|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Eye Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of eye symptoms, data of one participant each from the two groups are unavailable.||Score on a scale||Standard Deviation|Mean
18014|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Nose Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, data of one participant each from the two groups are unavailable.||Score on a scale||Standard Deviation|Mean
18015|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. 'Practical Problems' is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18016|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18017|NCT01817790|Secondary|Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. It measures five domains of functional impairment that are most important to subjects with SAR: practical problems, nasal symptoms, eye symptoms, activity limitations, and other symptoms. Participants scored their degree of impairment on a seven-point scale. (0 - 6). Mini RQLQ final score is the average of sub-scales, ranges from 0 (best possible outcome) to 6 (worst possible outcome).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, eye symptoms, and other symptoms, data of one participant each from the two groups are unavailable.||Score on a scale||Standard Deviation|Mean
18018|NCT01817790|Secondary|Mean Change in Objective Assessment of Conjunctival Redness|Conjunctival redness was evaluated as a clinical sign of SAR by the investigator. Scoring of severity was rated according to a 4-point scale: 0 = normal; 1 = Slightly pink; 2 = Moderately pink, some dilation; 3 = Intense red vessels, dilated.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18019|NCT01817790|Secondary|End-of-treatment Assessment of Response to Therapy for Ocular Symptoms|Overall response to therapy assessment was done using a 7-point categorical scale in which participants rated their response to therapy as follows: +3 = Significantly Improved; +2 = Moderately Improved; +1 = Mildly Improved; 0 = No Change; -1= Mildly Worse; -2 = Moderately Worse; -3 = Significantly Worse.|Day 14|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. In this outcome measure, in Fluticasone propionate group 313/314 participants, and in the placebo group 309/312 participants provided responses.||Participants|||Number
18020|NCT01817790|Secondary|Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)|The rNCSS is a participant perceived evaluation of overall congestion symptom severity (evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe) which was completed once in the evening (PM), and once in the morning (AM). rNCSS is defined as the average of the PM rNCSS and the AM rNCSS of the next day prior to AM dosing. The mean change from baseline in rNCSS (daily, AM, PM)was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18021|NCT01817790|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18044|NCT01816451|Primary|Fat Mass (%)|The subjects underwent a set of anthropometric assessments, which followed the norms of the International Society for Advancement of Kinanthropometry. The fat mass was calculated by percentage using the equation proposed by Jackson and Pollock (1978) from seven skinfold measurement. To measure the skinfolds, a Sanny Professional Skinfold Caliper was used.|Pre and post 14 weeks/46 sessions of training|||Fat Mass %||Standard Deviation|Mean
18022|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness|The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18023|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness|The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18024|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18025|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18026|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning|The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18027|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning|The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18028|NCT01817790|Secondary|Mean Change From Baseline in PM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18029|NCT01817790|Secondary|Mean Change From Baseline in AM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subjects completed rTOSS in the morning (AM score: prior to nasal spray use). The mean change from baseline in AM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18043|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.|Postoperative day 2|||units on a scale||Standard Deviation|Mean
18030|NCT01817790|Primary|Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)|The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject’s treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.||Score on a scale||Standard Deviation|Mean
18031|NCT01817777|Secondary|Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up|The number of participants who voluntarily discontinued participation in the study at any time or who were withdrawn by the investigator for pre-defined reasons was summarized.|Week 28|Observational Population: all participants enrolled into the study. If an enrolled participant withdrew from the study prior to the Week 8 visit, all available data on the participant was included in the Observational Population.||Participants|||Number
18032|NCT01817777|Secondary|Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons|The number of particiapnts who missed days or doses of metformin was summarized.|Week 28|Per Protocol Population||Participants|||Number
18033|NCT01817777|Secondary|Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication|Number of participants who preferred their treatment regimens (interventional arm treatment [large or small pack metformin]) to how they previously took their medication are presented.|Week 28|Per Protocol Population||Participants|||Number
18034|NCT01817777|Secondary|Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes|The number of participants who visited a health care professional for diabetes management during the study was summarized.|Week 28|Per Protocol Population||Participants|||Number
18035|NCT01817777|Secondary|Number of Participants With Diabetes Disease Management Modifications|Throughout the duration of the study, participants remained on their recommended metformin dosing regimens, unless a change in metformin dose was prescribed by their physician. The number of participants who received additional diabetes therapy for the management of diabetes was summarized.|Week 28|Per Protocol Population||Participants|||Number
18036|NCT01817777|Secondary|Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days|The number of days on which no metformin pills were taken by participants was summarized.|Week 28|Per Protocol Population||Participants|||Number
18037|NCT01817777|Secondary|Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase|Compliance was estimated during the 8-week Observational Phase for usual metformin treatment. During the Observational Phase, compliance was measured by monitoring the number of pill dispensed and the return of the pills or tablets.|From enrollment to Week 8|Per Protocol Population||Percent compliance||Standard Deviation|Mean
18038|NCT01817777|Secondary|Mean Percent Compliance Throughout the Interventional Phase|Compliance for the study was estimated as a percentage, with the denominator defined as the number of pills dispensed by the pharmacist and the numerator defined as the number of pills taken, accounting for remaining pills at subsequent pharmacy visits.|From Randomization to Week 28|Per Protocol Population||Percent compliance||Standard Deviation|Mean
18039|NCT01817777|Primary|Change From Baseline in HbA1c Values at Week 28|HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device. HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28). The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated. However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power. Therefore, the final analyses were limited to descriptive statistics. The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).|Baseline (Week 8) and Week 28|Per Protocol Population: all participants in the Intent-to-Treat Population (randomly assigned to treatment and who received >= 1 dose [or any portion of a dose] of study medication and had an HbA1c test at Week 8) who did not have a protocol violation||Percentage||Standard Deviation|Mean
18040|NCT01817764|Secondary|Change From Baseline in Trough FEV1 on Day 85|Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing/11 and 12 hours after evening dosing on Day 84. Change from Baseline is calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
18041|NCT01817764|Primary|Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose of randomized study medication in the treatment period. Only par. with analyzable data at the indicated time point were assessed, but all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
21231|NCT01748071|Secondary|Mean Heart Rate|According to the measurement of heart rate before and after intravenous injection of opioid analgesics|10 minutes after the procedure|||beats per minute||Standard Deviation|Mean
18045|NCT01816451|Primary|Rate of Perceived Exertion (RPE) on Maximal Test|"The RPE was collected at maximal test (see description of test on outcome measure Maximal Oxygen Uptake). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 – 10) scale. Instructions for RPE were that “0” corresponds to rest, and “9 - 10” corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre and post 14 weeks/46 sessions of training|||units on a scale||Standard Deviation|Mean
18046|NCT01816451|Primary|Body Mass (BM)|To measure body mass Filizola scales with a stadiometer was used.|Body Mass was collected pre and post training|||kg||Standard Deviation|Mean
18047|NCT01816451|Primary|Blood Lactate Concentrations on Maximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8–22 millimole (mM). The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument’s instructions. The finger never touched the strip’s pad in order to exclude any possible interference due to the sweat. All [La] were collected by a single, experienced investigator.|Pre and post 14 weeks/46sessions on rest (5 min sitting position; before start the test); 1-3-5 min immediately after the end of the test (on sitting position).|||mmol*L^-1||Standard Deviation|Mean
18048|NCT01816451|Secondary|Rate of Perceived Exertion (RPE) on Submaximal Test|"The RPE was collected at submaximal test (see description of test on outcome measure HR at submaximal test). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 – 10) scale. Instructions for RPE were that “0” corresponds to rest, and “9 - 10” corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training|The control group didn't do the submaximal test because it was done only for determine and adjusted the training intensities.||units on a scale||Standard Deviation|Mean
18049|NCT01816451|Secondary|Submaximal Velocity [Vsub]|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes. The test velocity should be clearly constant at the end of the test. Values of velocity were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the value of that speed has stabilized.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions of training|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [Vsub] during submaximal effort.||km/h||Standard Deviation|Mean
18050|NCT01816451|Secondary|Blood Lactate on Submaximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8–22 mM. The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood Measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument’s instructions we never let the finger touch the strip’s pad in order to exclude any possible interference due to the sweat.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46 sessions training: rest (5-min sitting; before start the test); 1-3-5 minutes immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [La] on rest and after submaximal effort during 14 weeks of training.||mmol*L^-1||Standard Deviation|Mean
18051|NCT01816451|Secondary|Heart Rate on Submaximal Test|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes.The test velocity should be clearly constant at the end of the test. Heart rate were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the HR values for training intensities.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training: rest (5-min sitting; before start the test); maximal during the test (maxHRsub); 60s-120s immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the training intensities during the 14 weeks.||bpm||Standard Deviation|Mean
18052|NCT01816451|Primary|Heart Rate on Maximal Test|The HR was collected pre and post training on maximal VO2 test. Initially, with the individual on the treadmill (Inbrasport Master Super, Porto Alegre, Brazil), electrodes (Micromed) were placed at the manubrium, right and left iliac crest for measured heart rate (HR) (derivation CM5) and were connected to an electromyography equipment (Micromed®). HR values were visualized through Elite software (Micromed Biotechnology, Brasilia, Brazil).|Pre and post 14 weeks at rest (5 min sitting; before start the test), during the test (to determine max), and 60s and 120s immediately after the end of the test (on sitting position)|||bpm||Standard Deviation|Mean
18053|NCT01816451|Primary|Total Time Reaching on Maximal Test (tVO2max)|The criterion for determining the total time reaching in maximal VO2 test was associated with the time immediately preceding heart rate shown a reduction of five or more beats.|Pre and post 14 weeks/46 sessions of training|||minutes||Standard Deviation|Mean
41620|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban Acylglucuronide After Three Days of 5 mg IV Daily in HRS Type 1 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
18054|NCT01816451|Primary|Absolute Maximal Oxygen Uptake|The absolute maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks|||L/min||Standard Deviation|Mean
18055|NCT01816451|Primary|Relative Maximal Oxygen Uptake|The relative maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks|||mL/(kg*min)||Standard Deviation|Mean
18056|NCT01816295|Secondary|Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)||Double Blind Baseline, Week 12, Open Label Baseline, Week 36|All participants with non-missing PSA result at the specified time point.||participants|||Number
18057|NCT01816295|Other Pre-specified|Change From Baseline in Total International Prostate Symptom Score (IPSS)|The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.|Baseline, Week 12, Week 36|All randomized participants with non-missing baseline IPSS measurement and at least one non-missing post baseline IPSS measurement. Missing data endpoints were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
18058|NCT01816295|Secondary|Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores|"The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with “10” corresponding to Full of Energy or Not Tired at All (The Tiredness scale was reverse-mapped, as it was collected with “10” corresponding to Extreme Tiredness). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low energy at baseline with non-missing HED questionnaire at baseline and at least one post baseline visit. Missing data endpoints were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
18059|NCT01816295|Secondary|Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores|"The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with 5 corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low sex drive at baseline with non-missing SAID Scale data at baseline and at least one post baseline visit. Missing data endpoints were imputed using last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
18060|NCT01816295|Primary|Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12|Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).|Week 12|All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12.||participants|||Number
18061|NCT01816243|Secondary|Number of Participants With Participant's Global Assessment|Participants global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100% worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with participant's global assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study drug and had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) = participants who were evaluable for this measure and 'n' = participants who were evaluable for this measure at given time points.||Participants|||Number
18062|NCT01816243|Secondary|Number of Participants With Investigator's Global Assessment|Investigator would complete a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent (%) worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with Investigator's assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
18063|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 30|Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
18108|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5|Up to 1 year|Number available for analysis varied by infusion; 52-58 subjects||ug/mL||Standard Error|Mean
18065|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
18066|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
18067|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
18068|NCT01815840|Secondary|Percentage of Participants Experiencing Any Adverse Event||Up to 125 weeks|Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.||percentage of participants|||Number
18069|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 125|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
18070|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 97|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
18071|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 85|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
18072|NCT01815840|Secondary|Percentage of Participants With New Basal Cell Carcinomas at Week 73||Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percentage of participants|||Number
18073|NCT01815840|Secondary|Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73||Baseline; Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.||percentage of participants|||Number
18074|NCT01815840|Secondary|Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73|The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.||percent change||Standard Deviation|Mean
18075|NCT01815840|Secondary|Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues|The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.|Baseline to Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.||percentage of participants||95% Confidence Interval|Number
18076|NCT01815840|Primary|Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)|The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used.||percent change||Standard Deviation|Mean
18077|NCT01815736|Secondary|Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48|"The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream).~EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit."|Baseline; Week 48|"Participants in EFV-Related Symptom Analysis Set with available data were analyzed.~NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut"||units on a scale||Standard Deviation|Mean
18078|NCT01815736|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|"Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut"||mg/dL||Standard Deviation|Mean
18079|NCT01815736|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."||percentage change||Standard Deviation|Mean
18109|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4|Up to 1 year|Number available for analysis varied by infusion; 53-58 subjects||ug/mL||Standard Error|Mean
18080|NCT01815736|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."||percentage change||Standard Deviation|Mean
18081|NCT01815736|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|"Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.~New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."||percentage of participants|||Number
18082|NCT01815671|Secondary|Pain Related or Possibly Related to Colonoscopy Procedure|Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.|24 hours|||units on a scale||Standard Deviation|Mean
18083|NCT01815671|Secondary|Time to Full Colonoscope Insertion||30 minutes|||minutes||Standard Deviation|Mean
18084|NCT01815671|Primary|Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure|The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.|24 hours|||participants|||Number
18085|NCT01815008|Secondary|Changes in Platelet Transcriptome With Clopidogrel|Platelet transcriptome will be examined before and after 1 week of therapy with clopidogrel and differences will be determined|At baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding. Note that the top most gene (CNOT2) with the lowest p-value is being reported.||FPKM||Standard Error|Mean
18086|NCT01815008|Secondary|Difference in Collagen-induced Platelet Aggregation|Collagen-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At Baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.||Difference in ohms (Post-Pre)||Standard Deviation|Mean
18087|NCT01815008|Secondary|Difference in Arachidonic Acid-induced Platelet Aggregation|Arachidonic Acid-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At baseline and after 1-week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.||Difference in ohms (Post-Pre)||Standard Deviation|Mean
18088|NCT01815008|Primary|Difference in ADP-induced Platelet Aggregation|ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.|at baseline and at 1 week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.||Difference in ohms (Post-Pre)||Standard Deviation|Mean
18089|NCT01814878|Secondary|Patient Global Impression of Change (PGIC) Score|The PGIC was used to assess the degree of participant’s overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened).|Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
18090|NCT01814878|Secondary|Dosage of Rescue Medication Administered Because of Insufficient Pain Relief|The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Milligram||Standard Deviation|Mean
18091|NCT01814878|Secondary|Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief|The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Doses||Standard Deviation|Mean
18092|NCT01814878|Secondary|Time to the First Rescue Medication Administered Because of Insufficient Pain Relief|The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular [directly into muscle] or intravenous injection [directly into vein]).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Minutes||Standard Deviation|Mean
18093|NCT01814878|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)|The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <= 3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
18094|NCT01814878|Secondary|Total Pain Relief (TOTPAR) Score|Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
18095|NCT01814878|Secondary|Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24|The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24.|Hour 6, 12, 24|The intent-to-treat population included all randomly assigned participants. Here, 'N' (number of participants analyzed) specifies those participants who were evaluable for this outcome measure.||Units on scale||Standard Deviation|Mean
18096|NCT01814878|Primary|Sum of Pain Intensity Difference (SPID) at Hour 48|The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).|Hour 48|The per-protocol (PP) population included all randomly assigned participants who did not violate major eligibility criteria and whose SPID was calculated with actual measurements or adjusted values at all assessment time points.||Units on scale||Standard Deviation|Mean
18097|NCT01814800|Post-Hoc|Number of Participants With No Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection. Presenting the number of subjects with no (0) days lost from work/school/daycare due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||participants|||Number
18098|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment - Per Subject-Year|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
18099|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
18100|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
18101|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
18102|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A|Up to 1 year|Number available for analysis varied by infusion; 51-54 subjects||ug/mL||Standard Error|Mean
18103|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
18104|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
18105|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
18106|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F|Up to 1 year|Number available for analysis varied by infusion; 53-57 subjects||ug/mL||Standard Error|Mean
18107|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects||ug/mL||Standard Error|Mean
18116|NCT01814800|Secondary|Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections|The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded)|Up to 1 year|||Linear Correlation Coefficients|||Number
18117|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
18118|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection)|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
18119|NCT01814800|Secondary|Days of Hospitalization Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
18120|NCT01814800|Secondary|Days of Hospitalization Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
18121|NCT01814800|Secondary|Number of Hospitalizations Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Hospitalizations per subject-year|||Number
18122|NCT01814800|Secondary|Number of Hospitalizations Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Number of hospitalizations|||Number
18123|NCT01814800|Secondary|Time to Resolution of Infections - Infection Days Per Subject||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject||Standard Deviation|Mean
18124|NCT01814800|Secondary|Time to Resolution of Infections - Duration Per Infection||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days||Standard Deviation|Mean
18125|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Number of Visits per subject-year|||Number
18126|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Number of Visits|||Number
18127|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days per subject-year|||Number
18128|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||Days|||Number
18129|NCT01814800|Secondary|Incidence of All Infections (Serious and Non-serious)||Up to 1 Year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||events per subject-year|||Number
18130|NCT01814800|Primary|Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))|The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.|One year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002||SBIs/subject/year|||Number
18131|NCT01814774|Secondary|Botulinum Toxin Inter-injection Interval|Injection-interval was the time in weeks between injections of botulinum toxin.|2 Years|All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.||weeks||Standard Deviation|Mean
18132|NCT01814774|Secondary|Number of Participants With Adverse Events|An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.|2 Years|Safety population included all participants who received at least one dose of botulinum toxin.||participants|||Number
18133|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Blepharospasm|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.||units per patient per year||95% Confidence Interval|Mean
18134|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Cervical Dystonia|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.||units per patient per year||95% Confidence Interval|Mean
18135|NCT01814761|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Percentage Change||95% Confidence Interval|Mean
18136|NCT01814761|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Patients|||Number
18468|NCT01808209|Primary|Dryness|Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
18137|NCT01814761|Secondary|Percentage of Patients Who Discontinue Due to an Adverse Event|An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Percentage of Patients|||Number
18138|NCT01814761|Secondary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
18139|NCT01814748|Secondary|Percentage of Participants Who Required Glycemic Rescue by Week 24|"Participants exceeding pre-specified glycemic thresholds after starting the double-blind treatment period may have received rescue therapy (per protocol) with open-label metformin initiated by the investigator.~This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|All randomized participants.||Percentage of participants|||Number
18140|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% (48 mmol/Mol) at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (cLDA). Within-group CIs were calculated via the Wilson score method.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||Percentage of participants||95% Confidence Interval|Number
18141|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (constrained longitudinal data analysis [cLDA] model). Within-group confidence intervals (CIs) were calculated via the Wilson score method.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||Percentage of participants||95% Confidence Interval|Number
18142|NCT01814748|Secondary|Change in Baseline in FPG at Week 24|"Blood glucose was measured on a fasting basis.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
18143|NCT01814748|Secondary|Change From Baseline in 2-hr PMG at Week 24|"Blood glucose was measured 120 minutes from start of meal.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
18144|NCT01814748|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.~The safety database was analyzed in a standard fashion in the APaT population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|APaT population included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
18145|NCT01814748|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.~The safety database was analyzed in a standard fashion in the all participants as treated (APaT) population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 27|APaT population included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
18146|NCT01814748|Primary|Change From Baseline in A1C at Week 24|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|Full analysis set (FAS) population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.||Percent||95% Confidence Interval|Least Squares Mean
18147|NCT01814722|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a 10-question dermatology-specific QOL questionnaire, which is calculated by summing the score of each question, resulting in a maximum of 30, and a minimum of 0. Higher scores mean the QOL is more impaired.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
18148|NCT01814722|Secondary|Change From Baseline in HIV Symptom Index (HIV-SI)|HIV-SI measures the frequency and level of bothersome HIV and HIV treatment-related symptoms, including nervous symptoms (dizziness, somnolence, trouble remembering), gastrointestinal symptoms (nausea, gas/bloating, diarrhea) and pain (hand/foot, muscle/joint). The 20-item questionnaire asks whether respondents experienced any one of these symptoms within the past 4 weeks, and if they did, what the relative level of bother for each symptom was, based on a 5-point Likert scale. The maximum sum of scores is 80; the minimum is 0; with a higher score indicating greater symptom distress.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
18149|NCT01814722|Secondary|Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)|DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
18150|NCT01814722|Primary|Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores|The MOS-HIV scale is a 35-item measure of health related quality of life (QOL) questionnaire which assesses 10 dimensions of health (general health perceptions, pain, physical functioning, role functioning, social functioning, mental health, energy/fatifue, cognitive function, health distress and QOL), as well as a single item to assess health transition. In addition to these subscales, a Physical Health Summary score (PHS) and a Mental Health Summary score (MHS) is calculated using a method where the summary scores are transformed to a standardized scale with a norm of 50 and a standard deviation of 10 in the sample in which the summary scores were developed. The subscales of the MOS-HIV are scored as summed rating scales ranging from a minimum of 0, to a maximum of 100, where higher scores indicate better health.|Week 4 Follow-up|Analyses were not performed due to too few participants.|||||
18151|NCT01814696|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score|"Health-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire consists of 21 items that assess the impact of HF and HF treatment on key physical, emotional, and social dimensions of a patient’s life during the past four weeks. Responses are coded from 0 = does not apply and 1 = very little to 5 = very much.~A higher score represents a greater negative HR-related impact on quality of life."|Baseline, end 3 months|||units on a scale||Standard Deviation|Mean
18152|NCT01814696|Secondary|Hospitalization, Length of Stay (Days)||3 months|Intention to treat analysis.||days||Standard Deviation|Mean
18153|NCT01814696|Secondary|Number of Hospitalization Visits.||3 months|Intention to treat analysis.||participants|||Number
18154|NCT01814696|Secondary|Number of Emergency Department (ED) Visits.||3 months|Intention to treat analysis.||participants|||Number
18155|NCT01814696|Secondary|Number of Participants With 1 or More Hospitalizations.||3 months|Intention to treat analysis.||participants|||Number
18156|NCT01814696|Secondary|Number of Participants With 1 or More Emergency Department (ED) Visits.||3 months|Intention to treat analysis.||participants|||Number
18157|NCT01814696|Primary|Morisky Medication Adherence Survey, 8-Items (MMAS-8)|Subject reported medication adherence. The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. Responses are summed from the 8-items to yield 3 categories of adherence: 0 = high adherence, 1-2 = medium adherence, and 3-8 = low adherence.|3 months|Participants who completed questions on enrollment and closeout survey.||participants|||Number
18158|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
18159|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
18322|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
18160|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1 and had data at the noted time point||Percentage of Subjects|||Number
18161|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
18162|NCT01814670|Primary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 30|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1||Percentage of Subjects|||Number
18163|NCT01814553|Secondary|PFS|"Progression-free survival (PFS). PFS was defined as the time from the start of treatment to an event occurred. In the analyses for the PFS endpoint, an event was defined as disease progression or death, whichever occurred earlier. Data for patients who did not die or progress during the trial were censored at the time of afatinib discontinuation or transition to commercially available afatinib. Median PFS is estimated using Kaplan-Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)."|Every 08 weeks during the first 6 months of treatment, and every 12 weeks thereafter until the end of treatment.|Treated Set||Months||95% Confidence Interval|Median
18164|NCT01814553|Secondary|Changes in Intensity of Diarrhea Over Time|Percentage of participants with grade 2 or higher diarrhea each week for the first 3 cycles of afatinib treatment|Up to 12 weeks (equivalent to 3 courses)|Treated set||Percentage of participants|||Number
18165|NCT01814553|Secondary|Duration of First Episode of Diarrhea Grade 2 or Higher|"Duration of first episode of diarrhea grade 2 or higher.~Please note that the nine patients experienced diarrhea episodes that were not managed according to the protocol specified afatinib treatment interruptions and dose reductions. No patients were excluded from the primary analysis."|From first drug administration until end of third treatment course, up to 84 days.|Treated set||days||Standard Deviation|Mean
18166|NCT01814553|Secondary|Time to Initial Onset of Diarrhea Grade 2 or Higher|Time to initial onset of diarrhea grade 2 or higher|From first drug administration until end of third treatment course, up to 84 days.|Treated set||days||Standard Deviation|Mean
18167|NCT01814553|Primary|Occurence of CTCAE Grade >= 2 Diarrhea|Overall incidence of patients who experienced diarrhea during the first three courses of afatinib treatment.|From first drug administration until 28 days after the end of third treatment course, up to 84 days.|Treated set||Percentage of participants|||Number
18168|NCT01814397|Other Pre-specified|Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy|Estradiol is being assessed using an ultrasensitive gas chromatography tandem mass spectroscopy-based assay. The lower limit of detection of the assay is 0.625 pg/ml. For patients whose serum estradiol concentrations were below the lower limit of detection, the value of 0.625 pg/ml was used to calculate the mean estradiol concentration and standard deviation at both baseline and 3 months.|Baseline, 3 months|||pg/ml||Standard Deviation|Mean
18169|NCT01814397|Other Pre-specified|Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment|Patients completed 4 measures at baseline, before aromatase inhibitor therapy initiation. (1) Depression: Center for Epidemiologic Studies-Depression, scores 0-60, higher scores reflect more depression. (2) Pain: 7 day Pain Diary, scores 0-10, higher scores reflect more pain. (3) Fatigue: Multidimensional Fatigue Inventory, scores 4-20, higher scores reflect more fatigue. (4) Sleep: Medical Outcomes Study-Sleep, scores 0-100, higher scores reflect worse sleep. Persistence with aromatase inhibitor therapy was assessed at the 6 month timepoint. Mean baseline values for each measure were calculated for the cohort that persisted with aromatase inhibitor therapy and the cohort that was non-persistent.|Baseline patient-reported outcomes measures, 6 month persistence with therapy|||units on a scale||Standard Deviation|Mean
18170|NCT01814397|Secondary|Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months|To assess conditioned pain modulation, pressure equivalent to the patient's Pain50 was applied to the non-dominant thumbnail for 30 seconds (test stimulus), and the patient rated the intensity of the pressure on a 0-100 pain scale at 10 second intervals. Ten minutes later pressure (conditioning stimulus) was continuously applied to the dominant thumbnail for 60 seconds at the same Pain50 intensity. After 30 seconds, the test stimulus was again applied to the non-dominant thumbnail for 30 seconds and the patient rated the intensity every 10 seconds. Conditioned pain modulation magnitude was calculated as the difference (second minus first) in the mean of the 3 pain ratings to the test stimulus applied prior to and during the conditioning stimulus. Conditioned pain modulation was assessed at baseline, 3 months, and 6 months. Change over that time period was assessed. Higher conditioned pain modulation values indicate less efficient conditioned pain modulation.|Baseline, 3 months, 6 months|||units on a scale (0-100 pain scale)||Standard Deviation|Mean
18171|NCT01814397|Primary|Mean Pain50 Assessed at Baseline, 3 Months and 6 Months|Patients rated the intensity of each pressure sensation using a 0 to 100 numerical rating scale (0 = no pain, 100 = worst pain imaginable). Pain50 was defined as the amount of applied pressure in kilograms per square centimeter that evoked a pain intensity rating of 50 out of 100. Pain50 was assessed at baseline, 3 months, and 6 months. Change in Pain50 with estrogen depletion was determined.|Baseline, 3 months, 6 months|||kg/cm^2||Standard Deviation|Mean
18172|NCT01814332|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Baseline, Week 6|||participants|||Number
18173|NCT01814332|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|||Score on a scale||Standard Deviation|Mean
18174|NCT01814332|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured as having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6|||participants|||Number
18175|NCT01814332|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, 6 weeks|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.||score on a scale||Standard Deviation|Mean
18176|NCT01814137|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One subject in each arm did not have FPG values from week 0.||mmol/L||Standard Deviation|Mean
18177|NCT01814137|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.||episodes|||Number
18178|NCT01814137|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"Confirmed hypoglycaemic episodes were defined as episodes that are either:~severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or~biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.||episodes|||Number
18179|NCT01814137|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.|During 26 weeks of treatment|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product.||number of events|||Number
18180|NCT01814137|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
18181|NCT01813890|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||Percentage of participants|||Number
18182|NCT01813890|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
18183|NCT01813890|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
18221|NCT01812707|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
18184|NCT01813890|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
18185|NCT01813890|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.||Percentage of Participants|||Number
18186|NCT01813890|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.||Percentage of Participants|||Number
18187|NCT01813890|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|up to 48 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.||Hours||Inter-Quartile Range|Median
18188|NCT01813890|Primary|Sum of Pain Intensity Difference (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.||units on a scale||Standard Deviation|Mean
18189|NCT01813721|Secondary|Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP|At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant’s medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1.|At Baseline and at enrolment, prior to chemotherapy initiation.|Primary analysis set, participants with investigator-assessed FN risk at or above the investigator FN-risk intervention threshold||percentage of participants|||Number
18190|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18191|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18192|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18222|NCT01812681|Secondary|Sepsis|Association of vitamin D level with sepsis|four weeks|||participants|||Number
18223|NCT01812681|Primary|Respiratory Distress Syndrome|The association of vitamin D level with respiratory distress syndrome|three days|||participants|||Number
18193|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18194|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only includes subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18195|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.||percentage of investigators|Participants|95% Confidence Interval|Number
18196|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.||percentage of investigators|Participants|95% Confidence Interval|Number
18197|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.||percentage of investigators|Participants|95% Confidence Interval|Number
18198|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18199|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18200|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18469|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.|Baseline|Prior to randomization||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
18201|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18202|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; subgroup analyses were only performed on subgroups (countries) with at least 100 participants.||percentage of participants||95% Confidence Interval|Number
18203|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set||percentage of participants||95% Confidence Interval|Number
18204|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.||percentage of investigators|Participants|95% Confidence Interval|Number
18205|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.||percentage of investigators|Participants|95% Confidence Interval|Number
18206|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.||percentage of investigators|Participants|95% Confidence Interval|Number
18207|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators||percentage of investigators|Participants|95% Confidence Interval|Number
18208|NCT01813721|Primary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set||percentage of participants||95% Confidence Interval|Number
18470|NCT01808209|Primary|Dryness|Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
18209|NCT01813721|Primary|Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|At enrolment, prior to chemotherapy initiation|Primary analysis set which consists of all participants who satisfied the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment.||percentage of participants||95% Confidence Interval|Number
18210|NCT01813721|Primary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).||percentage of investigators|Participants|95% Confidence Interval|Number
18211|NCT01813721|Primary|Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|Baseline (prior to participant enrolment)|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).||percentage of investigators|Participants|95% Confidence Interval|Number
18212|NCT01813019|Secondary|Y-BOCS Reduction in Total Score From Baseline|If a subject demonstrates at least 25% reduction in total Y-BOCS from Baseline then they will be classed as a responder whereas if a subject has a reduction in Y-BOCS of less than 25% then they will be categorized as a nonresponder.|16 weeks|The study was terminated due to an interim analysis of the primary efficacy outcome. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective therefore secondary objective was not measured.|||||
18213|NCT01813019|Primary|Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing).|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0–7 = sub-clinical 8–15 = mild 16–23 = moderate 24–31 = severe 32–40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change."|baseline, week 17|Pharmacodynamics (PD) analysis set only participants that were analyzed at baseline and Week 17. Positive change from baseline indicates a decrease in symptom severity||Scores on a scale||Standard Error|Least Squares Mean
18214|NCT01812837|Primary|Actinic Keratoses Reduction Percent||one month after treatment|||percentage||Standard Deviation|Mean
18215|NCT01812707|Secondary|Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of ApoB/ApoA-1 ratio analyzed.||ratio||Standard Error|Least Squares Mean
18216|NCT01812707|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of Fasting Triglycerides and Lipoprotein (a) analyzed.||percent change||Inter-Quartile Range|Median
18217|NCT01812707|Secondary|Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of lipid parameters analyzed.||percent change||Standard Error|Least Squares Mean
18218|NCT01812707|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.||percentage of participants|||Number
18219|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mg/dL||Standard Error|Least Squares Mean
18220|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mmol/L||Standard Error|Least Squares Mean
18224|NCT01812655|Secondary|Engagement With Distraction and Belief in Distraction's Efficacy|"For Engagement with Distraction,VR and PD participants were asked on the Post-testing Questionnaire: Were you able to pay attention to the DVD or to the VR during your burn treatment? (1=could not pay attention at all; 5=totally absorbed at all times)~For Belief in Distraction's Efficacy, VR and PD participants were asked on the Post-Procedure Questionnaire: I believe that the distraction lessened my pain during my burn treatment today. (on a scale of 1=Distraction did not help to lessen my pain at all; 5=Distraction completely helped to lessen my pain at all times)"|Post-procedure (approximately 30-75 minutes)|||scores on a scale||Standard Deviation|Mean
18225|NCT01812655|Secondary|Desire for Distraction|"Participants were asked I wanted to be distracted from during my treatment today. (Agree-Disagree) from the Post-Procedure Questionnaire"|Post-procedure (approximately 30-75 minutes)|||participants|||Number
18226|NCT01812655|Primary|Self-reported Wound Care Procedure Pain Score|The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).|Within the first 20 minutes following completion of the burn wound care procedure|Intention to treat||mm||95% Confidence Interval|Least Squares Mean
18227|NCT01812473|Primary|Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.|At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.|At steady state plasma concentration of voriconazole (after day 4 of therapy)|||% of plasma protein binding|Participants|Inter-Quartile Range|Median
18228|NCT01812044|Secondary|Peak Pain Score During First 30 Minutes|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~Pain is rated every 5 minutes for the first 30 minutes postoperatively."|0-30 minutes post-operative|||units on a scale||Standard Deviation|Mean
18229|NCT01812044|Secondary|Number of Participants Who Required Anti-emetic Medication Post-operatively||Total time in post-operative recovery - up to 6 hours|||participants|||Number
18230|NCT01812044|Secondary|Number of Participants With Post Operative Nausea and Vomiting||0-150 minutes post-operative|||participants|||Number
18231|NCT01812044|Secondary|Average Time to Discharge||0-150 minutes post-operative|||minutes||Standard Deviation|Mean
18232|NCT01812044|Secondary|Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)|"This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively.~with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior.~Lowest score 27; highest score 135"|1 week (+/- 3 days) post operatively|||units on a scale||Standard Deviation|Mean
18233|NCT01812044|Secondary|Total Narcotic Use During Post-operative Recovery|This secondary outcome will include total narcotic use|Total time in post-operative recovery - up to 6 hours|||mcg/kg||Standard Deviation|Mean
18234|NCT01812044|Secondary|Peak Pain Score|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge."|0-150 minutes post-operative|||units on a scale||Standard Deviation|Mean
18235|NCT01812044|Primary|Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale|"Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for “Average pain score over the first 30 post-operative minutes using the CHEOPS scale.” for each group."|0-30 minutes post-operative|||units on a scale||Standard Deviation|Mean
18236|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
18237|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Metformin|Cmax: maximum measured concentration of the analyte in plasma for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
41621|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban Acylglucuronide After Three Days of 5 mg IV Daily in HRS Type 1 Patients||3 days|||ng/mL||Standard Deviation|Mean
18238|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin|Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
18239|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
18240|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
18241|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
18242|NCT01811706|Secondary|Biomechanical Assessment of Gait (BAG)-Stride Length|Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. Stride length was analyzed. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo|||cm||Standard Deviation|Mean
18243|NCT01811706|Secondary|Change in Scale of Assessment and Rating of Ataxia (SARA)|Scale for the assessment and rating of ataxia (SARA) is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level. SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. SARA score ranges from 0 to 40, with higher scores indicating more severe disease.|Baseline and 4 weeks after Dalfampridine or placebo|||point||Standard Deviation|Mean
18244|NCT01811706|Primary|Change in Timed 25 Feet Walking Test (T25FW)|The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo|Patient with spinocerebellar ataxia (SCA) 1, 2, 3, or 6||second||Standard Deviation|Mean
18245|NCT01811680|Primary|10 Meter Walk Test|Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)|8 weeks|||m/s||Standard Deviation|Mean
18246|NCT01811680|Primary|6 Minute Walk Test (Metres)|6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8)|8 weeks|chronic stroke||metres||Standard Deviation|Mean
18247|NCT01811485|Secondary|Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death|The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|14 weeks|Safety set (SAF): consists of all patients who received at least one dose of study medication.||Patients|||Number
18248|NCT01811485|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline to 14 weeks|FAS consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||mg/dL||Standard Error|Least Squares Mean
18249|NCT01811485|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|"Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c < 7% 3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c < 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%.~Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements."|Baseline, 14 weeks|The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||Percentage of patients|||Number
18471|NCT01808209|Primary|Comfort|Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
18250|NCT01811485|Secondary|Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups|HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
18251|NCT01811485|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
18252|NCT01811472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability||24 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least 1 post-baseline safety assessment.||Patients|||Number
18253|NCT01811472|Secondary|Change From Baseline in Waist Circumference||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis||centimeter (cm)||90% Confidence Interval|Least Squares Mean
18254|NCT01811472|Secondary|Change From Baseline in Body Weight||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis||kilogram (kg)||90% Confidence Interval|Least Squares Mean
18255|NCT01811472|Secondary|Post-prandial Peak Triglycerides Over 0 - 8 Hours|"Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours.~Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis||mg/dL||90% Confidence Interval|Geometric Mean
18256|NCT01811472|Secondary|Percent Change From Baseline in Fasting Triglycerides|"Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast.~Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis||percent change||90% Confidence Interval|Geometric Mean
18257|NCT01811472|Secondary|Percentage of Patients With Normalized Liver Enzymes|Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose.|Baseline, week 6, week 12 and week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoints were included in this endpoint analysis.||Percentage of patients|||Number
18258|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 24 were included in this endpoint analysis.||U/L||90% Confidence Interval|Least Squares Mean
18259|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 12 were included in this endpoint analysis.||U/L||90% Confidence Interval|Least Squares Mean
18260|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 6|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoint were included in this endpoint analysis.||U/L||90% Confidence Interval|Least Squares Mean
18261|NCT01811472|Secondary|Percentage of Responders at Week 24|"The response criteria are defined as:~a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 24 were included in this endpoint analysis.||Percentage of responders|||Number
18262|NCT01811472|Secondary|Percentage of Responders at Week 12|"The response criteria are defined as:~a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|At week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 12 were included in this endpoint analysis.||Percentage of responders|||Number
18263|NCT01811472|Secondary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 12 are included in this analysis.||Percentage of liver fat||90% Confidence Interval|Least Squares Mean
18264|NCT01811472|Primary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 24 are included in this analysis.||Percentage of liver fat||95% Confidence Interval|Least Squares Mean
18265|NCT01811303|Secondary|Maximum Blood Glucose Concentration (C Max) Over the Baseline|"Determine the glucose C max of Sucrose with D-fagomine over the baseline.~The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline.~Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)"|Usually in the range of 30-45 minutes|||mmol/L||Standard Error|Mean
18266|NCT01811303|Primary|Postprandial Glycaemic Response Index|On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.|120 minutes|The number of participants >10, the repetitions >= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145–171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09.||percentage of AUC fagomine/AUC control||95% Confidence Interval|Mean
18267|NCT01811238|Secondary|Patient Global Impression of Change(PGIC)|Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Baseline, 8week|IIT set, Missing values were imputed by LOCF.||participants|||Number
18268|NCT01811238|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline, 8 weeks|ITT set, Missing values were imputed by LOCF. Difference (Visti 4(8w)-Baseline)||scores on a scale||Standard Deviation|Mean
18269|NCT01811238|Secondary|Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 4/ET minus mean score at Baseline."|Baseline, 4 week|IIT set.||units on a scale||Standard Deviation|Mean
18270|NCT01811238|Secondary|Clinical Global Impression of Change(CGIC)|"The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF.~Very much improved much improved minimally improved no change minimally worse much worse very much worse"|Baseline, 8 week|ITT Population. Below results : Visit 4(8week)(LOCF): n(%)||participants|||Number
18271|NCT01811238|Secondary|The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by “1” means that the healthy condition and high quality of life."|Baseline, 8 week|ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.Missing values were imputed by LOCF.||scores on a scale||Standard Deviation|Mean
18320|NCT01809938|Primary|Tmax|tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements.|Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours|||minutes||Standard Deviation|Mean
18272|NCT01811238|Primary|Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 8/ET minus mean score at Baseline."|Baseline, 8 week|"The 209 is IIT set population. ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.~Missing values were imputed by LOCF."||scores on a scale||Standard Deviation|Mean
18273|NCT01810952|Post-Hoc|Percent of Glucose Determinations >180 mg/dL||1-5 days|||Percent of glucose values|||Number
18274|NCT01810952|Secondary|Glucose Values <70 mg/dL.|# participants with glucose values <70 mg/dL|1-5 days|||participants|||Number
18275|NCT01810952|Secondary|Daily Insulin Dose/Kg Body Weight|Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL|1-5 days|||units of insulin/Kg body weight||Standard Deviation|Mean
18276|NCT01810952|Secondary|Percent of Participants With Average Glucose >70 and <180 mg/dL|Percent of Participants with Average Daily Glucose >70 and <180 mg/dL|Last Full Day of Protocol for Participant (up to Day 5)|||percentage of participants|||Number
18277|NCT01810952|Primary|Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.|"Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."|1-5 days|We used t-tests to compare values between the protocols on each day..||mg/dL||Standard Deviation|Mean
18278|NCT01810939|Primary|Change in Serum Potassium From Part B Baseline|"Change in Serum Potassium from Part B Baseline to either:~Part B Week 4 visit, if the participant’s serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant’s serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L."|Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L|||mEq/L||Inter-Quartile Range|Median
18279|NCT01810939|Primary|Change in Serum Potassium From Part A Baseline to Part A Week 4|The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).|Part A Baseline to Part A Week 4|||mEq/L||Standard Error|Least Squares Mean
18280|NCT01810939|Secondary|Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B||Part B Baseline to Part B Week 8|Percentages were estimated not as simple ratios, but by using a stratified method, in order to account for differences between the patiromer and placebo groups in terms of whether participants had type 2 diabetes mellitus and whether they entered the study with serum potassium < 5.8 mEq/L or serum potassium ≥ 5.8 mEq/L.||percentage of participants|||Number
18281|NCT01810939|Secondary|Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B||Part B Baseline to Part B Week 8|||percentage of participants|||Number
18282|NCT01810939|Secondary|Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4||Week 4|Proportion of participants with serum potassium level in the target range at Part A Week 4||percentage of participants||95% Confidence Interval|Number
18283|NCT01810692|Secondary|Overall Satisfaction Question|The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.|day 1|Patients from FAS||units on a scale||Standard Deviation|Mean
18284|NCT01810692|Secondary|Total Convenience PASAPQ Score|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.||units on a scale||Standard Deviation|Mean
18285|NCT01810692|Secondary|Total Performance PASAPQ Score.|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.||units on a scale||Standard Deviation|Mean
18286|NCT01810692|Primary|Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)|Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.||units on a scale||Standard Deviation|Mean
18287|NCT01810666|Secondary|Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period|Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set.|From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)|||Scores on scale||95% Confidence Interval|Median
18288|NCT01810666|Secondary|Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period|Annualized joint bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)|||Bleeds||95% Confidence Interval|Median
18289|NCT01810666|Primary|Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period|Annualized bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)|||Bleeds||95% Confidence Interval|Median
18321|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
18290|NCT01810380|Secondary|PSP Domain D: Disturbing and Aggressive Behaviours at Week 6|PSP domain D: disturbing and aggressive behaviours were categorised as “aggressive” (corresponding to mild, manifest, marked, severe, or very severe) or “nonaggressive” (corresponding to absent)|Week 6|FAS. As this was based on observed cases, only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used.||percentage of aggressive patients|||Number
18291|NCT01810380|Secondary|PSP Functional Response Rate at Week 6|The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.||percentage of responders|||Number
18292|NCT01810380|Secondary|PSP Functional Remission Rate at Week 6|The PSP functional remission rate was defined as a PSP total score ≥71|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.||percentage of remitters|||Number
18293|NCT01810380|Secondary|Change From Baseline to Week 6 in PSP Total Score|The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient’s current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance.|Baseline and Week 6|FAS. PSP was collected at Baseline, Day 21 and Day 42 only, due to the windowing only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF.||units on a scale||Standard Error|Mean
18294|NCT01810380|Secondary|Response Rate at Week 6|The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2|Baseline and Week 6|FAS (last assessment)||percentage of responders|||Number
18295|NCT01810380|Secondary|Discontinuation Due to Lack of Efficacy During the Study|Discontinuation due to lack of efficacy was based on the primary reason for withdrawal|Baseline to Week 6|APTS||percentage of patients|||Number
18296|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18297|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18298|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18299|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18300|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18301|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Excited Component Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18302|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18303|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18304|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18305|NCT01810380|Secondary|CGI-I Score at Week 6|"The Clinical Global Impression – Global Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening).~The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not."|Week 6|FAS||units on a scale||Standard Error|Mean
18306|NCT01810380|Secondary|Change From Baseline to Week 6 in CGI-S Score|"The Clinical Global Impression – Severity of Illness (CGI-S) provides the clinician’s impression of the patient’s current state of mental illness.~The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients)."|Baseline and Week 6|FAS||units on a scale||Standard Error|Mean
18307|NCT01810380|Primary|Change From Baseline to Week 6 in PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline and Week 6|Full-analysis set (FAS)||units on a scale||Standard Error|Mean
18308|NCT01810302|Secondary|Number of Participants With Cerebral Vasospasm.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.|||||
18309|NCT01810302|Primary|Number of Participants With Bacterial Meningitis.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.|||||
18310|NCT01810263|Other Pre-specified|Subjective Global Assessment||6 months||||||
18311|NCT01810263|Other Pre-specified|Triceps Skin Fold Thickness||6 months||||||
18312|NCT01810263|Other Pre-specified|Body Mass Index||6 months||||||
18313|NCT01810263|Secondary|Chemical Laboratory Findings||6 months||||||
18314|NCT01810263|Primary|Modified Barthel Index (MBI) Score at 6 Months|Scale range: 0-100 (higher values represent a better outcome)|6 months|||units on a scale||Standard Deviation|Mean
18315|NCT01810042|Secondary|Visual Acuity Changes|"Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline.~Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline."|baseline and 6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.||ETDRS letters||Full Range|Median
18316|NCT01810042|Secondary|Visual Acuity in ETDRS Letters|Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.||ETDRS letters||Full Range|Median
18317|NCT01810042|Secondary|Lesion Size of CNV|Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.||square milimeter||Full Range|Mean
18318|NCT01810042|Primary|Caliber of Choroidal New Vessel (CNV)|Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.|6 months|Of 31 patients included in the baseline analysis, 7 patients had the thickest vessels under limitation of measurement.||micrometer||Full Range|Mean
18319|NCT01809938|Secondary|T½|"T½ = time from baseline to the time the cross-sectional surface area (CSA) of the gastric antrum, measured using realtime ultrasound, returned to half the maximal value (CSA½max ). CSA ½ max calculated as below:~CSA½max = CSAmax - [(CSAmax - CSAbaseline)/2]"|Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours.|It was difficult to visualise under ultrasound the gastric antrum in one patient after they drank both black tea and tea with milk, so they were exlcuded from final analysis of the US data only.||minutes||95% Confidence Interval|Geometric Mean
18323|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination).~(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion, 12-hours, 1-week|||logMAR|Participants|Standard Deviation|Log Mean
18324|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination).~(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion|||logMAR|Participants|Standard Deviation|Log Mean
18325|NCT01809834|Primary|Participant's Subjective Rating of Overall Preference (Questionnaire)|Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week|12-hours, 1-week|||score on a scale||Standard Deviation|Mean
18326|NCT01809834|Primary|Participant's Subjective Rating of Visual Quality (Questionnaire)|Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week|12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
18327|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)|Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week|12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)||units on a scale|Participants|Standard Deviation|Mean
18328|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)|Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing|Dispense|||score on a scale|Participants|Standard Deviation|Mean
18329|NCT01809834|Primary|Participant's Subjective Rating of Dryness (Questionnaire)|Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week|12-hours, 1-week|||units on a scale|Participants|Standard Deviation|Mean
18330|NCT01809834|Secondary|Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)|"Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good).~Change over time measured at insertion, 12-hours, 1-week"|Insertion, 12 hours, 1 week|||units on a scale|Participants|Standard Deviation|Mean
18331|NCT01809834|Secondary|Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)|"Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced).~Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week)."|Insertion, 12 hours, 1 week|||units on a scale|Participants|Standard Deviation|Mean
18332|NCT01809834|Primary|Participant's Subjective Rating of Comfort (Questionnaire)|Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week|Insertion, After Lens settling, 12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)||units on a scale|Participants|Standard Deviation|Mean
18333|NCT01809639|Primary|Time (in Days) That a Patient Reports Symptoms From Their Concussion.|The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline.|From date of injury until date asymptomatic, assessed up to 24 months|||Days Symptomatic||Standard Error|Mean
18334|NCT01808339|Secondary|Peak Expiratory Flow (PEF)|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. AM and PM pre-treatment PEF was measured throughout the study for the purposes of monitoring participants’ asthma stability, and was measured from the start of the Run-in Period until completion of Treatment Period 3 (including during the washout periods), prior to study medication and/or any rescue albuterol/salbutamol inhalation aerosol use. The data collected were only assessed by the Investigator on an individual basis during the study and were not formally summarized or statistically analyzed; consequently, data are not reported.|Up to 18 weeks||||||
18335|NCT01808339|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were collected from the start of dosing with investigational product and until follow-up.|Up to 18 weeks|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
18336|NCT01808339|Secondary|Pre-treatment AM and PM Trough FEV1 on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). FEV1 PM trough FEV1 values were the values taken pre-treatment on Day 14, and AM trough FEV1 values were the values taken pre-treatment on Day 15 in each treatment period; thus, there is only one value (pre-treatment record) per period for AM and PM trough.|Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants available at the specified time points were analyzed||Liters||Standard Error|Least Squares Mean
18472|NCT01808209|Primary|Comfort|Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
18337|NCT01808339|Primary|Weighted Mean Forced Expiratory Volume in 1 Second (FEV1) Measured Over 24 Hours at Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at 3, 6, 9, 12, 15, 18, 21, and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of three technically acceptable measurements was recorded. FEV1 weighted mean was analyzed using a mixed effects analysis of a covariance model with fixed effect terms for treatment and period, participant Baseline, period Baseline, gender, and age as covariates, and participant as a random effect.|24 hours post-PM dose on Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
18338|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||Full Range|Median
18339|NCT01808326|Secondary|Elimination Half-life (t1/2) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||95% Confidence Interval|Geometric Mean
18340|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Phenyl Acetic Acid Mustard|Blood samples for PK analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
18341|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
18342|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||Full Range|Median
18352|NCT01808326|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
18343|NCT01808326|Secondary|Elimination Half-life (t1/2) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour||95% Confidence Interval|Geometric Mean
18344|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Chlorambucil|Blood samples for PK analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
18345|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
18346|NCT01808326|Secondary|Expression of Complement CH50|Peripheral samples were collected for the analysis of complement CH50 at Baseline (Day 1 of Cycle 1) and after completion of Cycle 4 (Day 85).|Baseline, Cycle 1-Day 1, and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilounit /Liter||Standard Deviation|Mean
18347|NCT01808326|Secondary|Expression of Beta 2 Microglobulin|Blood samples were collected at the Baseline (Day 1 of Cycle 1) visit for prognostic biomarker Beta 2 microglobulin measurements.|Baseline (Cycle 1 Day 1)|All Subjects Population||Nanomoles per Liter||Standard Deviation|Mean
18348|NCT01808326|Secondary|Number of Participants With Positive Minimal Residual Disease (MRD)|MRD refers to the small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR and in whom bone marrow test was performed. A bone marrow sample was examined by flow cytometry (Cluster of differentiation [CD]5, CD19, CD20, and CD23). MRD positive is defined as more than one CLL cell per 10000 leukocytes.|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
18349|NCT01808326|Secondary|Change From Baseline in the Immunoglobulin(Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.Peripheral samples were collected for the analysis of IgA, IgG, and IgM at Baseline and 28 days after Day 1 of the last treatment cycle (FU 1-PDFU 1) for all participants, and 168 days after day of FU 1-PDFU 1 for participants with CR, PR, and SD. Baseline was the last pre-dose assessment performed on Cycle 1-Day 1. The the last assessment performed prior to pre-dose Cycle 1-Day 1 was used if Cycle 1-Day 1 was missing. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
18350|NCT01808326|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Adverse Event of Infection or Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Number of participants with a Grade 3 or Grade 4 adverse event of infection or myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
18351|NCT01808326|Secondary|Number of Participants With Adverse Events by the Indicated Maximum Toxicity Grade|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Non-hematologic AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE V4.03): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE|From the start of treatment up to Week 61.1|All Subjects Population||Participants|||Number
18353|NCT01808326|Secondary|Number of Participants With no B-symptoms and With at Least One B-symptom Over Time|The number of participants with no B-symptoms (no night sweat, no weight loss, no fever and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at C1 D1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
18354|NCT01808326|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, Up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was last pre-dose assessment performed on Cycle 1 Day 1(C1 D1). When C1 D1 was missing, the last assessment performed prior to pre-dose C1 D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, Cycle (C) 2-Day (D) 29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1- PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
18355|NCT01808326|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From the start of treatment until the first administration of the next CLL treatment (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Weeks||95% Confidence Interval|Median
18356|NCT01808326|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the initial response (CR or PR) until progression or death. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the initial response (CR/PR) until disease progression or death (up to Week 61.1)|All Subjects Population||Weeks||95% Confidence Interval|Median
18357|NCT01808326|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as time from the start of treatment until the first response (CR/PR). Time to Response analyses was restricted to the subgroup of the population who experienced an overall response (CR/ nPR/CRi/PR) during the study. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until the first response (CR/PR) (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Weeks||95% Confidence Interval|Median
18358|NCT01808326|Secondary|Overall Survival (OS)|Overall survival is defined as time from the start of treatment until death due to any cause. Participants who had not died were censored at the date of last contact.|From the start of treatment until death (up to Week 61.1)|All Subjects Population||Weeks||95% Confidence Interval|Median
18359|NCT01808326|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator and the IRC|Progression-free survival (PFS) is defined as the time from the start of treatment of investigational product until the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population||Weeks||95% Confidence Interval|Median
19251|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 24.|24 weeks|in the sugar pill arm one participant dropped out at week 12||ng/dL||Standard Deviation|Mean
18360|NCT01808326|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the Investigator, IRC and IRC With CT|OR is defined as the number of participants achieving either a confirmed CR or PR. Assessment was completed by the Investigator, IRC, and IRC with CT. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population||Participants|||Number
18361|NCT01808326|Primary|Number of Participants With a Best Response of Either Complete Remission (CR), Nodular Partial Remission (nPR), Complete Remission-incomplete (CRi) or Partial Remission (PR), as Assessed by the Investigator, IRC and IRC With CT|According to the criteria based on the 2008 revision of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) of the National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG), participants with complete remission (CR), nodular partial remission (nPR), complete remission-incomplete (CRi) and partial remission (PR) were classified as responders, while stable disease (SD) and progressive disease (PD) were classified as non-responders. Participants with unknown or missing responses were considered as non-responders. Assessment was completed by the Investigator, Independent Review Committee (IRC), and IRC with Computed Tomography (CT).|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population: all participants who received at least one dose of investigational product.||Participants|||Number
18362|NCT01809327|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Up to 30 weeks of last study drug administration|Safety Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug.||participants|||Number
18363|NCT01809327|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percent change||Standard Deviation|Mean
18364|NCT01809327|Secondary|Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percent change||Standard Error|Least Squares Mean
18365|NCT01809327|Secondary|Change in Systolic Blood Pressure From Baseline at Week 26|The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||millimeter of mercury (mm Hg)||Standard Error|Least Squares Mean
18366|NCT01809327|Secondary|Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26|The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.|Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percentage of participants|||Number
18367|NCT01809327|Secondary|Percent Change in Body Weight From Baseline to Week 26|The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percent change||Standard Error|Least Squares Mean
18368|NCT01809327|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26|The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."||percentage of hemoglobin||Standard Error|Least Squares Mean
18369|NCT01809314|Secondary|Percentage of Participants Who Required Blood Transfusions During the Study|The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.|Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4|"All Participants Enrolled. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants who provided data for the analysis at each timepoint (n) is shown in the table."||percentage of participants|||Number
19252|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status||At Screening|Tumour Evaluable Population||Participants|||Number
18370|NCT01809314|Secondary|Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT|"ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as Baseline 0, EOT 2. Transition to a lower performance status indicates improved/increased independence."|Baseline, Month 4|"All Participants Enrolled; only those who provided data at all study visits were included in the analysis. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants used in the denominator for each calculation (n) was based on the ECOG status at Baseline."||percentage of participants|||Number
18371|NCT01809314|Primary|Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)|The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).|Baseline, Month 4|All Participants Enrolled; only those who provided data at all study visits were included in the analysis.||g/L||95% Confidence Interval|Mean
18372|NCT01809262|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline and Visit 6|Safety set.||mmol/L||Inter-Quartile Range|Geometric Mean
18373|NCT01809262|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|2 weeks|Safety set||percentage of participants|||Number
18374|NCT01809262|Secondary|Number of Patients Requiring Rescue Medication on a Test-day|Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.|Visits 1,2,4,5,6|Safety set which consisted of all randomised patients who had taken at least one dose of study medication.||Number of Patients|||Number
18375|NCT01809262|Secondary|Time to Onset of Response|Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.||minutes||Standard Deviation|Mean
18376|NCT01809262|Secondary|Time to Peak Bronchodilator Response|A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.||minutes||Standard Deviation|Mean
18377|NCT01809262|Secondary|Peak Forced Vital Capacity (FVC) From 0 to 3 Hours|Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
18378|NCT01809262|Secondary|Peak FEV1 From 0 to 3 Hours|Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
18379|NCT01809262|Secondary|FEV1 AUC 12 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
18380|NCT01809262|Secondary|FEV1 AUC 0 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
18381|NCT01809262|Secondary|FEV1 AUC 0 - 12 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
18382|NCT01809262|Secondary|FEV1 AUC 0 - 3 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint||L||Standard Error|Mean
19253|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country||At Screening|Tumour Evaluable Population||Participants|||Number
18383|NCT01809262|Primary|Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment|Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.|24 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data for FEV1 at 24 hours.||L||Standard Error|Mean
18384|NCT01809197|Primary|"Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses"|Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.|Day 30; after 4 hours of lens wear|This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.||units on a scale||Standard Deviation|Least Squares Mean
18385|NCT01809106|Other Pre-specified|The Opioid Escalation Index|The proportion of subjects with an increase of opioid daily dose > 5% compared with the basal dosage (OEI%).|28 days|||participants|||Number
18386|NCT01809106|Secondary|Proportion of Full-responder|Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/> 30% from visit 6 and visit 1 (NRS 0 to 10).|28 days|||participants|||Number
18387|NCT01809106|Primary|Proportion of Non-Responder (NR) Participants|Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity “stable” or “worsened” at day 28 compared with baseline values.|28 days|Intention-to-treat||participants|||Number
18388|NCT01809054|Secondary|Deep Vein Thrombosis|verified by ultrasound|6 weeks|||participants|||Number
18389|NCT01809054|Primary|Blood Loss|requiring transfusion|6 weeks|||participants|||Number
18390|NCT01808963|Primary|Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine|Respired gas heat content|1 year.|||Joules per minute||Standard Deviation|Mean
18391|NCT01808950|Secondary|Global Judgment of Tolerability by Investigator by Means of a 6-point Scale||8 weeks after a maximal treatment period of 4 weeks||||||
18392|NCT01808950|Secondary|Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs||up to 12 weeks||||||
18393|NCT01808950|Secondary|Evaluation of Local Tolerability by Means of 5-point Scales|local skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation judged by investigator by means of 5-point scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).|up to 12 weeks||||||
18394|NCT01808950|Secondary|Complete Clinical Clearance Rate||8 weeks after the 4 weeks treatment period|data were not collected for any of study participant.|||||
18395|NCT01808950|Primary|Histological Cure Rate||8 weeks after a maximal treatment period of 4 weeks|data were not collected for any of study participant.|||||
18396|NCT01808755|Primary|Days|time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture|168|||days||Standard Deviation|Mean
18397|NCT01808651|Secondary|Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline up to 52 weeks|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||units on a scale||Standard Error|Least Squares Mean
18398|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score. LSM (least square mean) and SE (standard error) are from visit 16.||units on a scale||Standard Error|Least Squares Mean
18399|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
18400|NCT01808651|Secondary|Percentage of Participants Achieving a Remission at Week 52|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to Week 52|Participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||percentage of participants|||Number
18401|NCT01808651|Secondary|Percentage of Participants Achieving a Response at Week 52|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|Baseline, up to Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||Percentage of participants|||Number
18402|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during Study Period 1.||units on a scale||Standard Error|Least Squares Mean
18403|NCT01808651|Primary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 52|Participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during Study Period 1.||participants|||Number
18404|NCT01808651|Primary|Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)||Baseline through Week 52.|Participants who received at least 1 dose of the study drug were evaluated for AEs and SAEs. SAE reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 1.||participants|||Number
18405|NCT01808612|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through 6 weeks|Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period.||participants|||Number
18406|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline, up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data.||units on a scale||Standard Error|Least Squares Mean
18407|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
18408|NCT01808612|Secondary|Percentage of Participants Achieving a Remission at 6-Week Endpoint|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||percentage of participants|||Number
18409|NCT01808612|Secondary|Percentage of Participants Achieving a Response at 6-Week Endpoint|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.||percentage of participants|||Number
18460|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.|Dispense|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||logMAR||Standard Deviation|Mean
18461|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.|Baseline|||logMAR||Standard Deviation|Mean
18410|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
18411|NCT01808612|Primary|Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period.||units on a scale||Standard Error|Least Squares Mean
18412|NCT01808547|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.||participants|||Number
18413|NCT01808534|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.|Up to 2 years|All patients who enrolled and received treatment.||participants|||Number
18414|NCT01808534|Secondary|Overall Survival|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.|Up to 2 years|All patients who enrolled and received treatment.||months||90% Confidence Interval|Median
18415|NCT01808534|Secondary|Progression Free Survival (PFS)|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Up to 2 years|All patients who enrolled and received treatment.||months||90% Confidence Interval|Median
18416|NCT01808534|Secondary|Duration of Remission in Patients Who Achieve a Partial or Complete Response|The duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.|Up to 2 years|||months||90% Confidence Interval|Median
18417|NCT01808534|Primary|Overall Response Rate (Defined as Partial Response or Complete Response)|The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.|Up to 2 years|All patients who enrolled and received treatment with at least one post baseline assessment.||percentage of participants||95% Confidence Interval|Number
18418|NCT01808508|Secondary|Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months|As secondary outcome of the second aim, we will use the distance walked during the 6 minute walk test.|4 Months|The majority of subjects were unable to follow instructions properly and therefore none could successfully complete the test. Thus the results were not considered to be valid.|||||
18419|NCT01808508|Secondary|Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months|The change in left ventricular mass index score, measured on echocardiography, was used to assess the relationship between obstructive sleep apnea syndrome and cardiovascular function of individuals with Down syndrome. Left ventricular (LV) mass was calculated from M-mode measurements of the LV end-diastolic dimension, the thickness of the interventricular septum and the thickness of the LV posterior wall, and presented as a z-score.|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up||z-score||Inter-Quartile Range|Median
18420|NCT01808508|Secondary|Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months|The change in behavioral domain was measured by the Child Check Behavior List. The CBCL is a widely used method of identifying problem behavior in children. Problems are identified by a respondent who knows the child well, usually a parent or other care giver. There are 2 versions based on the child's age (CBCL/1½-5 for use children 18 months-5 years; the CBCL/6-18 for children aged 6-18 years). The checklists consists of a number of statements about the child's behavior and responses are recorded on a scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The preschool checklist contains 100 questions and, school-age checklist contains 120 questions. 8 sub-scores (1 for each of 8 syndromes: anxious/depressed, withdrawn depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior and aggressive behavior) are calculated, each ranging from 0 (normal) to 16 (clinical behavior).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up||units on a scale||Inter-Quartile Range|Median
18462|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|1 Week|||units on a scale||Standard Deviation|Mean
18421|NCT01808508|Primary|Change in Epworth Sleepiness Scale From Baseline to End of Study|The primary aim of the study is to assess the relationship between obstructive sleep apnea syndrome (OSAS) and the neurocognitive and behavioral outcomes of individuals with Down syndrome. Sleepiness was assessed using the pediatric version of the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person’s general level of daytime sleepiness, or average sleep propensity in daily life. The ESS asks people to rate, on a 4-point scale (0, low to 3, high) their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives. The total ESS score provides an estimate of a general characteristic of each person's average level of sleepiness in daily life (0= no chance of dozing/no daytime sleepiness to 24=high chance of dozing/lots of daytime sleepiness).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up||units on a scale||Inter-Quartile Range|Median
18422|NCT01808313|Secondary|Number of Participants With Urinalysis Data at Baseline and Week 24|Urine samples were collected for urinalysis at Baseline and Week 24. The Number of participants with urinalysis to negative and positives (trace, +, ++ and +++) data at Baseline and Week 24 are summarized for urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine nitrite (UNIT), urine protein (UM) and urine urobilinogen (UUBIL) were performed with dipstick method. Other urinalysis parameters included urine pH (UpH), urine specific gravity (USG). The Baseline value is defined as the last pre-treatment value observed.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
18423|NCT01808313|Secondary|Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/Bun at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/BUN values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Millimoles per liter||Standard Deviation|Mean
18424|NCT01808313|Secondary|Mean Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine and uric acid at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the direct bilirubin, total bilirubin, creatinine and uric acid values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Micromoles per liter||Standard Deviation|Mean
18425|NCT01808313|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH) at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the ALP, ALT, AST, CK, GGT and LDH values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||International units per liter||Standard Deviation|Mean
18426|NCT01808313|Secondary|Change From Baseline in Albumin, Globulin and Total Protein at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of albumin, globulin and total protein at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the albumin, globulin and total protein values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
18427|NCT01808313|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of RBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the red blood cell count values were summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Trillion cells per liter||Standard Deviation|Mean
18463|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|Baseline|||units on a scale||Standard Deviation|Mean
18428|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle volume at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the mean corpuscle volume values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Femtoliters||Standard Deviation|Mean
18429|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Picogram||Standard Deviation|Mean
18430|NCT01808313|Secondary|Change From Baseline in Hematocrit at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hematocrit at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hematocrit values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is defined as the last Pre-treatment value observed. The unit of measure is defined as the proprtion of red blood cells in blood.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Proportion of 1||Standard Deviation|Mean
18431|NCT01808313|Secondary|Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Grams per liter||Standard Deviation|Mean
18432|NCT01808313|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Giga cells per liter||Standard Deviation|Mean
18433|NCT01808313|Secondary|Number of Participants With Shift From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) and Total Bilirubin (BILT) up to Week 24|Blood samples were collected for the measurement of ALT, ALP, AST and BILT at the Baseline visit and up to Week 24. Shift from Baseline (BL) was calculated as the individual maximum of post-BL value minus the BL value. The BL value is defined as the last pre-treatment value observed. Threshold values for the liver function test results, which were considered as potential values of clinical concern, were 3 times the upper limit of normal (ULN) for ALT, AST and ALP and 2 times the ULN for BILT. Maximum liver function abnormal values of post-BL are summarized.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
18434|NCT01808313|Secondary|Oral Temperature|Oral temperature was used to monitor vital signs and collected at the Screening visit.|Baseline|Safety Population||Celsius||Full Range|Mean
18435|NCT01808313|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points up to Week 24|Vital sign monitoring included heart rate measurements at (pre-6MWT and post-6MWT at the Baseline visit, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing value observed before treatment. At Baseline, Weeks 12 and 28, heart rate was recorded at the end of the 6MWT and at 1 minute (M), 2 M and 3 M, after completion of the 6MWT with the participants seated, and the time that heart rate recovered to the level of pre-6MWT.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute||Standard Deviation|Mean
18464|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
18465|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|Baseline|||units on a scale||Standard Deviation|Mean
18436|NCT01808313|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at the Indicated Time Points up to Week 24|Blood pressure measurements (pre-6MWT and post-6MWT) were taken to monitor vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in SBP and DBP were summarized for each post-Baseline assessment upto Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
18437|NCT01808313|Secondary|Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24|The ECG parameters, PR interval, QRS duration, uncorrected QT interval, QTcB were measured at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Milliseconds||Standard Deviation|Mean
18438|NCT01808313|Secondary|Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24|Heart rate was measured in order to monitor vital signs by the 12-lead ECG at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment at Weeks 12 and 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute||Standard Deviation|Mean
18439|NCT01808313|Secondary|Number of Participants With Physical Examination Findings|Complete physical examinations of each participant by the investigator were performed at the Screening Visit, Week 12 and Week 24 Visit/Early withdrawal visits. The physical examination included an examination of the following: general appearance, skin, head, ears, eyes, nose, throat, neck, thyroid, lymph nodes, cardiovascular system, respiratory system, abdomen, musculoskeletal system, neurological system and height. Physical examination summary results were not collected therefore there is no data to present for this outcome measure.|Baseline, Week 12 and Week 24|Safety Population||Participants|||Number
18440|NCT01808313|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation|An adverse event (AE) is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, or important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment up to Week 24|Safety Population||Participants|||Number
18441|NCT01808313|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from Baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or Investigational product (IP) discontinuation (discon) due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events during 12 and 24 Weeks.|Baseline up to Week 24|Safety Population: This population comprised of all participants who received at least one dose of study medication.||Participants|||Number
18442|NCT01808313|Secondary|Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate maker of heart failure and was measured by a central laboratory. Mean change from Baseline at Weeks 12 and 24 were calculated as the Weeks 12 and 24 values minus the Baseline values.Observed data was analyzed (no imputation technique was performed for missing data). Log transformed mean change from Baseline at Weeks 12 and 24 data are summarized.|Baseline, Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by number of participants [n]=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflect everyone in the ITT Population.||log(ng/L)||Standard Deviation|Mean
18443|NCT01808313|Secondary|Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from Baseline was calculated as the Week 12 and 24 values minus the Baseline values. The BDI indicates the degree of exertion, breathlessness, fatigue, or difficulty breathing after completion of the 6MWT. The lower values, 0 as the lowest, indicates no exertion, fatigue, or breathlessness felt, and 10 would be the maximum amount of exertion felt as assessed by each participant. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population.||scores on a scale||Standard Deviation|Mean
18466|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
18467|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|Baseline|||units on a scale||Standard Deviation|Mean
18444|NCT01808313|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|The WHO FC was determined by the investigator as follows: Class I- Participants with pulmonary hypertension (PH) but without resulting limitation of physical activity, II- Participants with PH resulting in slight limitation of physical activity, III- Participants with PH resulting in marked limitation of physical activity, IV- Participants with PH with inability to carry out any physical activity without symptoms. Changes from Baseline in functional class were summarized at Weeks 12 and 24. The number of participants improving by 2 classes, improving by 1 class, not changing, worsening by 1 class or worsening by 2 classes from Baseline at Weeks 12 and 24 were evaluated. The Baseline value was the last non-missing assessment value before treatment. Only participants with non-missing Baseline values and at least one non-missing post-Baseline value of the response variable were included. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population||Participants|||Number
18445|NCT01808313|Secondary|Change From Baseline in 6MWT at Week 24|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10%. If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 24|ITT Population.||Meters||Standard Deviation|Mean
18446|NCT01808313|Primary|Change From Baseline in 6-minutes Walk Test (6MWT) at Week 12|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10 percent (%). If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and had an efficacy assessment performed both at Baseline and after administration of the study medication||Meters||Standard Deviation|Mean
18447|NCT01808248|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
18448|NCT01808248|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 12 weeks|Full Analysis Set||percentage of participants|||Number
18449|NCT01808248|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
18450|NCT01808248|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants enrolled and received at least 1 dose of study drug||percentage of participants|||Number
18451|NCT01808248|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
18452|NCT01808209|Primary|Wettability|Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||seconds|Participants|Standard Deviation|Mean
18453|NCT01808209|Secondary|Conjunctival Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale|Participants|Standard Deviation|Mean
18454|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week|||units on a scale|Participants|Standard Deviation|Mean
18455|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|Baseline|Prior to randomization||units on a scale|Participants|Standard Deviation|Mean
18456|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||percentage of redness|Participants|Standard Deviation|Mean
18457|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.|Baseline|||percentage of redness|Participants|Standard Deviation|Mean
18458|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
18459|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||logMAR||Standard Deviation|Mean
19254|NCT01788163|Secondary|Number of Organs With Metastasis by Plasma EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Plasma Evaluable Population||Number||Standard Deviation|Mean
18473|NCT01808209|Primary|Handling|Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||units on a scale||Standard Deviation|Mean
18474|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)|1 week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.||hours||Standard Deviation|Mean
18475|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)|Baseline|||hours||Standard Deviation|Mean
18476|NCT01808092|Secondary|The Proportion of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The proportion of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.|up to 25 days from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
18477|NCT01808092|Secondary|The Proportion of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set|The proportion of patients discharged from hospital in the clinically modified intent-to-treat analysis set.|up to 25 days from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18478|NCT01808092|Secondary|The Proportion of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The proportion of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.|up to 25 days from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18479|NCT01808092|Secondary|The Proportion of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28|The proportion of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28.|at Day 28 from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
18480|NCT01808092|Secondary|The Proportion of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28|The proportion of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18481|NCT01808092|Secondary|The Proportion of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28|The proportion of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18482|NCT01808092|Secondary|The Proportion of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The proportion of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
18483|NCT01808092|Secondary|The Proportion of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The proportion of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18484|NCT01808092|Secondary|The Proportion of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The proportion of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18525|NCT01808066|Other Pre-specified|Post Interview With Teachers to Qualitatively Assess Interest in Using the Game With Students and Any Improvements to be Made|Researchers will ask teachers for qualitative feedback once participants have completed game play about interest in using the game and any improvements to be made.|Day 21||||||
18526|NCT01808066|Other Pre-specified|Post Interview With Participants to Qualitatively Identify Themes of Interest and Quality of Life Effects|After playing game for three weeks, researchers will interview participants about their interest in the game and changes in quality of life (no forms).|Day 21||||||
18485|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)||participants with favorable responses|||Number
18486|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)||participants with favorable responses|||Number
18487|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)||participants with favorable responses|||Number
18488|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)||participants with favorable responses|||Number
18489|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)||participants with favorable responses|||Number
18490|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)||participants with favorable responses|||Number
18491|NCT01808092|Secondary|Proportion of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC||participants|||Number
18527|NCT01808066|Other Pre-specified|Pre Interview With Teachers to Qualitatively Identify Themes of Motivation and Interest|Researchers will conduct interviews with teachers and collect all notes/journals recorded. Specific questions will be asked about their perception of participant's attention, interest and motivation to play the game. Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1||||||
18492|NCT01808092|Secondary|Proportion of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC||participants|||Number
18493|NCT01808092|Secondary|Proportion of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC||participants|||Number
18494|NCT01808092|Secondary|Proportion of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT||participants|||Number
18495|NCT01808092|Secondary|Proportion of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT||participants|||Number
18496|NCT01808092|Secondary|Proportion of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT||participants|||Number
18497|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)||participants|||Number
18498|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)||participants|||Number
18499|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)||participants|||Number
18500|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)||participants|||Number
18501|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)||participants|||Number
18502|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)||participants|||Number
18503|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)||participants with favorable responses|||Number
18504|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)||participants with favorable responses|||Number
18505|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)||participants with favorable responses|||Number
18506|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)||participants with favorable responses|||Number
18507|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)||participants with favorable responses|||Number
18827|NCT01800318|Secondary|Duration of Crying After TENS Unit Was Initiated But Before Heel Stick.|(a) Any crying after initiation of TENS unit was noted. If the PIPP scores increased by 4 points from baseline, the TENS unit would have been turned off and the infant withdrawn from the study (safety outcome).|10 minutes|||seconds||Standard Deviation|Mean
18508|NCT01808092|Secondary|The Proportion of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The proportion of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)||participants with favorable responses|||Number
18509|NCT01808092|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
18510|NCT01808092|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
18511|NCT01808092|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
18512|NCT01808092|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
18513|NCT01808092|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18514|NCT01808092|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18515|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
18528|NCT01808066|Secondary|Pre Interview With Participants to Qualitatively Identify Interest and Motivation|Researchers will conduct interviews with players and collect all notes/journals recorded. Specific questions will be asked about their perception of their attention, interest and motivation to play the game. Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1||||||
21232|NCT01748071|Secondary|Mean Arterial Pressure|According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics|10 minutes after the procedure|||mmHg||Standard Deviation|Mean
18516|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
18517|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
18518|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18519|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The proportion of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|At the end of treatment (EOT) visit (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18520|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).||participants|||Number
18521|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.||participants|||Number
18522|NCT01808092|Secondary|The Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
18523|NCT01808092|Primary|The Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.||participants|||Number
18524|NCT01808092|Primary|The Proportion of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)|The proportion of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.||participants|||Number
21689|NCT01738971|Other Pre-specified|Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews.||8 months||||||
18529|NCT01808066|Primary|Number of Participants With an Increase/Improvement in Focusing|Researchers will observe and record data during the first play session. Over the three weeks, teachers/support staff will be asked to observe players each day and record their observations as needed in a journal. These observations will measure their improvement in their ability to focus by assessing their engagement, time played, frequency of play, ability to complete a session and ability to start and finish a session. At the end of three weeks, researchers will attend the final play session and record observations in writing.|3 weeks|||participants|||Number
18530|NCT01807949|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough,avg, C3-6h, and C3-6h,avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,avg is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough,avg is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
18531|NCT01807949|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug. Participants were analyzed as per actual treatment received.||participants|||Number
18532|NCT01807949|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."||units on a scale||Standard Error|Least Squares Mean
18533|NCT01807949|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant’s self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
18534|NCT01807949|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
18535|NCT01807949|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.||percentage of participants|||Number
18536|NCT01807949|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression method. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.||days||Full Range|Median
18537|NCT01807949|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.||z-score||Standard Error|Least Squares Mean
18538|NCT01807949|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Error|Least Squares Mean
18564|NCT01807624|Secondary|Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
18539|NCT01807949|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.||pulmonary exacerbation events per year|||Number
18540|NCT01807949|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.||percentage of participants|||Number
18541|NCT01807949|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
18542|NCT01807949|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
18543|NCT01807949|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent change||Standard Error|Least Squares Mean
18544|NCT01807949|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Error|Least Squares Mean
18545|NCT01807923|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough, avg, C3-6h, and C3-6h, avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough, ave is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
18546|NCT01807923|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Treatment-Emergent Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Nonserious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug.||participants|||Number
18547|NCT01807923|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."||units on a scale||Standard Error|Least Squares Mean
18548|NCT01807923|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant’s self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
18565|NCT01807624|Secondary|Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
18566|NCT01807624|Secondary|Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
18549|NCT01807923|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
18550|NCT01807923|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.||percentage of participants|||Number
18551|NCT01807923|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.||days||Full Range|Median
18552|NCT01807923|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from –infinity to + infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using Centers for Disease Control and Prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.||z-score||Standard Error|Least Squares Mean
18553|NCT01807923|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Error|Least Squares Mean
18554|NCT01807923|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.||pulmonary exacerbation events per year|||Number
18555|NCT01807923|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.||percentage of participants|||Number
18556|NCT01807923|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
18557|NCT01807923|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
18558|NCT01807923|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent change||Standard Error|Least Squares Mean
18559|NCT01807923|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at Week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Error|Least Squares Mean
18560|NCT01807624|Secondary|SpO2 Decrease of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
18561|NCT01807624|Secondary|SpO2 Increase of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
18562|NCT01807624|Secondary|Decrease in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
18563|NCT01807624|Secondary|Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray|||participants|||Number
18575|NCT01807455|Secondary|Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)|Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.|36 weeks|||percentage of participants|||Number
18576|NCT01807455|Secondary|Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire|Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.|36 weeks|||percentage of participants|||Number
18577|NCT01807455|Primary|Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale|Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.|36 weeks|||percentage of participants|||Number
18578|NCT01807156|Secondary|Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Measurable lesions: Lesions that can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan.~Non-measurable lesions: All other lesions including small lesions (longest diameter < 20 mm with conventional techniques) and other non-measurable lesions including: pleural effusions, ascites, and disease documented by indirect evidence (e.g. biochemical abnormalities).~Target lesions: All measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.~Non-target lesions: All other lesions are identified as non-target lesions and should be followed as present or absent."|6 months|No response was observed in any of the patients.||participants|||Number
18579|NCT01807156|Primary|Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression|Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are all measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.|6 Months|||participants|||Number
18580|NCT01807000|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||percentage of radioactivity||Standard Deviation|Mean
18581|NCT01807000|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate||240 hours post-dose|Pharmacokinetic Analysis Set||percentage of radioactvity||Standard Deviation|Mean
18582|NCT01807000|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
18583|NCT01807000|Primary|Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Full Range|Median
18584|NCT01807000|Primary|Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents/ml||Standard Deviation|Mean
18585|NCT01807000|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents*h/ml||Standard Deviation|Mean
18586|NCT01807000|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
18587|NCT01807000|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Full Range|Median
18588|NCT01807000|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents/ml||Standard Deviation|Mean
18589|NCT01807000|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng equivalents*h/ml||Standard Deviation|Mean
18590|NCT01807000|Primary|Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate|The distribution of a medication between plasma and the rest of the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||Liters||Standard Deviation|Mean
18591|NCT01807000|Primary|Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate|The rate at which a drug is removed from the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||L/h||Standard Deviation|Mean
18592|NCT01807000|Primary|Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate|The time it takes for the blood plasma concentration of a substance to halve.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
18593|NCT01807000|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||hours||Full Range|Median
18594|NCT01807000|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic Analysis Set||ng/ml||Standard Deviation|Mean
18609|NCT01806623|Secondary|Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
18595|NCT01807000|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|The Pharmacokinetic Analysis Set included all subjects with at least 1 pharmacokinetic parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set which included all subjects who took 1 dose of investigational product, underwent plasma pharmacokinetic sampling, and had evaluable pharmacokinetic assay results.||ng*h/ml||Standard Deviation|Mean
18596|NCT01806961|Secondary|Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area|recording of adverse events|at 6 and 12 months||||||
18597|NCT01806961|Secondary|Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)|clinical examination|at 6 and 12 months||||||
18598|NCT01806961|Primary|Determine the Recurrence Rate of AK-lesions|Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.|at 6 and 12 months|No subject was analysed due to premature study termination (sponsor's decision) therefore no data was available for analysis|||||
18599|NCT01806779|Other Pre-specified|Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day|A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).||percentage of change||Standard Error|Mean
18600|NCT01806779|Secondary|Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit|This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) <10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Quit Day to 11-week post Quit Day study visit|||participants|||Number
18601|NCT01806779|Secondary|Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day|This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.|6 months post Quit Day|||participants|||Number
18602|NCT01806779|Primary|Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits|This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) <10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Period between 8-week and 11-week visits post target Quit Day|||participants|||Number
18603|NCT01806623|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
18604|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||hrs||Full Range|Median
18605|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
18606|NCT01806623|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg*h/g||Geometric Coefficient of Variation|Geometric Mean
18607|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||hours||Full Range|Median
18608|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.||mcg/g||Geometric Coefficient of Variation|Geometric Mean
21690|NCT01738971|Secondary|Proportion of Women Who Agree to Participate Who Can be Successfully Contacted||8 months|||participants|||Number
18610|NCT01806623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.||hours||Full Range|Median
18611|NCT01806623|Secondary|Maximum Observed Plasma Concentration (Cmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
18612|NCT01806623|Secondary|Total Scores for Clinical Symptoms|Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).|Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||score on s scale||Full Range|Mean
18613|NCT01806623|Secondary|Mycological Efficacy: Eradication Rate|"Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate.~Eradication rate was calculated based on the following formula, the number of participants assessed as Eradication over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
18614|NCT01806623|Secondary|Clinical Efficacy: Cure and Improvement Rate|"Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).~Cure and improvement rate was calculated based on the following formula, the number of participants assessed as Cure or Improvement over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
18615|NCT01806623|Secondary|Clinical Efficacy: Cure Rate|"Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).~Cure rate was calculated based on the following formula, the number of participants assessed as Cure over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
18616|NCT01806623|Primary|Therapeutic Outcome: Response Rate|"Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication.~Primary evaluation of therapeutic outcome was on Day 28.~Response rate was calculated based on the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.||percentage of participants||95% Confidence Interval|Number
18617|NCT01806584|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||interventions||Standard Deviation|Mean
18618|NCT01806584|Secondary|Percentage of Participants With Loss of Secondary Patency|Secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVG placement) until the date of access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||percentage of participants|||Number
18886|NCT01798485|Secondary|Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal.|up to 36 months|Randomized participants with elevated LDH at screening||months||95% Confidence Interval|Median
18619|NCT01806584|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|Assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVG placement) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||percentage of participants|||Number
18620|NCT01806584|Primary|Percentage of Participants With Loss of Unassisted Primary Patency|Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft [AVG] placement) until the first date of (a) any intervention designed to establish, maintain, or restore patency, (b) occlusion (commonly due to thrombosis), or (c) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The Intent to-Treat (ITT) population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.||percentage of participants|||Number
18621|NCT01806545|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total number of interventions to establish, maintain, or restore patency was recorded for each participant.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||interventions||Standard Deviation|Mean
18622|NCT01806545|Secondary|Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis|Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
18623|NCT01806545|Secondary|Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS|B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.|1, 12, and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||millimeters||Standard Deviation|Mean
18624|NCT01806545|Secondary|Percentage of Participants With Loss of Secondary Patency|The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
18625|NCT01806545|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
18626|NCT01806545|Secondary|Percentage of Participants With Loss of Unassisted Primary Patency|The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
18627|NCT01806545|Secondary|Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination|Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||days||Inter-Quartile Range|Median
18910|NCT01798004|Other Pre-specified|Overall Survival||Up to 5 years||||||
18911|NCT01798004|Other Pre-specified|EFS||Up to 5 years||||||
18912|NCT01798004|Other Pre-specified|Response Rate Determined Using the International Response Criteria||Up to 5 years||||||
18628|NCT01806545|Secondary|Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
18629|NCT01806545|Primary|Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.|12 weeks after surgery|The Intent- to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.||percentage of participants|||Number
18630|NCT01806051|Primary|Changes in Plasma Phe and Tyrosine Levels|To evaluate the patterns of change in plasma Phe and tyrosine levels between the Baseline visit and 4 week visit for each arm.|Baseline and 4 weeks|Participants withdrew before any data were collected.|||||
18631|NCT01805687|Secondary|Number of Subjects With Adverse Events||72 Hours||||||
18632|NCT01805687|Secondary|Area Under the Curve (AUC)||72 Hours||||||
18633|NCT01805687|Primary|Change From Baseline in FEV1||12 Hours|||Liter||Standard Deviation|Mean
18634|NCT01805323|Secondary|Peak Mean Change From Baseline in Central Retinal Thickness (CRT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.|Baseline, 2 to 26 weeks following last injection (up to 6.5 months)|All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks.||microns (μm)|Participants|Standard Error|Mean
18635|NCT01805323|Primary|Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.|Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)|All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.||Lines|Participants|Standard Error|Mean
18636|NCT01805180|Secondary|Safety|"Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs).~any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA."|48-hours after last procedure|||events|||Number
18637|NCT01805180|Secondary|Usability/Assessment of System Operation - Device Malfunctions||Result know immediately upon successful completion of procedure|||events|||Number
18638|NCT01805180|Secondary|Usability/Assessment of System Operation - Adjustments|Number of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate.|Adjustments known immediately upon completion of the procedure|||number of adjustments||Standard Deviation|Mean
18639|NCT01805180|Secondary|Usability/Assessment of System Operation - Time|Procedure time for collections on the Spectra Optia vs. the COBE Spectra.|Result captured immediately upon completion of procedure|||minutes||Standard Deviation|Mean
18640|NCT01805180|Secondary|Characterization of the Blood Product - Volume|Characterization of the collected blood product, specifically product volume.|within 5 minutes after collection procedure|||mL||Standard Deviation|Mean
18641|NCT01805180|Secondary|Characterization of the Blood Product - RBC Contamination|Characterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product.|within 5 minutes after collection procedure|||RBC percent of product volume||Standard Deviation|Mean
18642|NCT01805180|Secondary|Characterization of the Blood Product - PMN Cell Viability|Characterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product.|within 5 minutes after collection procedure|||percent of viable cells||Standard Deviation|Mean
18643|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed|Characterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device.|within 5 minutes after each collection procedure|||cells *10^10 per L of blood processed||Standard Deviation|Mean
18644|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield|Characterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product.|within 5 minutes after each collection procedure|||cells *10^10||Standard Deviation|Mean
18942|NCT01797380|Primary|Reduction in Depressive Symptoms|Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.|9 weeks.|Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data.|||||
18645|NCT01805180|Secondary|Performance|Comparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure|||percent of cells processed||Standard Deviation|Mean
18646|NCT01805180|Primary|Granulocyte/PMN Cell Collection Efficiency|The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure|||percent cells processed||Standard Deviation|Mean
18647|NCT01805089|Secondary|Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months|Mood was assessed by the Center for Epidemiologic studies Depression Scale. The scale measures depressive symptoms in 20 items. Each question has a 4 point answer (0-3) so the scale range is 0-60. A higher score indicates more depression. Sleep quality was assessed by the Pittsburgh Sleep Quality Index. There are 19 questions each with a 3 point answer. The questions are grouped into 7 subscales and each has a value from 0-3. The 7 subscales are then added together to yield a global score with a range of 0-21. Higher scores indicate worse sleep. Menopausal symptoms were assessed by NCCTG Hot Flash diary. Subjects track the number and severity of hot flashes daily for 1 week. Subjects grade the severity of the hot flashes on a scale of 1-4, with 1 being mild and 4 very severe. Frequency and the severity determine the score . The minimum score is 0 (no hot flashes) and there is no maximum score. A higher score indicates more severe hot flashes. There are no subscales or no units.|baseline and 4 months|||change in PSQI score||Standard Deviation|Mean
18648|NCT01805089|Primary|Compliance|To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.|4 months|||participants|||Number
18649|NCT01805089|Primary|Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo|Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.|4 months|||pg/ml||Standard Deviation|Mean
18650|NCT01804946|Secondary|Percentage of Patients With Complications of the Influenza|Pneumonia, sinusitis, otitis media are examples of the influenza complications|Day 1 to Day 7|Per Protocol set||Percentage of participants|||Number
18651|NCT01804946|Secondary|Change in the Subjective Health Status|The patient subjective health status assessment was based on Visual Analogue Scale − VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).|Day 7 vs. Day 1|Per Protocol set||Scores on a scale||Standard Deviation|Mean
18652|NCT01804946|Secondary|Change in the Patient’s Quality of Life.|The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).|Day 7 vs. Day 1|Per Protocol set||Scores on a scale||Standard Deviation|Mean
18653|NCT01804946|Secondary|The Number of the Antipyretic Intake|A subject recorded the number of antipyretic intake in patient diary.|Day 1 to Day 5|Per Protocol set||Number of Doses||Standard Deviation|Mean
18654|NCT01804946|Secondary|Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)|The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom’s total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)|on days 1, 3 and 7 of the observation|Per Protocol set||Scores on a scale||Standard Deviation|Mean
18655|NCT01804946|Secondary|Mean Body Temperature|The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)|on days 1, 3 and 7 of the observation|Per Protocol set||°C||Standard Deviation|Mean
18656|NCT01804946|Secondary|Time to Resolution of the Influenza|"Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms.~The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7."|Day 1 to Day 7|Per Protocol set||Days||Standard Deviation|Mean
18657|NCT01804946|Secondary|Percentage of Patients With Resolution of Influenza Symptoms|Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom|on the day 7 of the observation|Per Protocol set.||Percentage of participants|||Number
18658|NCT01804946|Primary|Percentage of Patients With Normal Body Temperature|Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)|Day 1 to Day 5|The Per Protocol (PP) set includes subjects received full per protocol therapy, completed all scheduled visits and had no substantial deviations from the protocol. Since PP-analysis and ITT-analysis demonstrated similar (confirmative) results the results of PP-analysis are presented.||Percentage of participants|||Number
18659|NCT01804881|Secondary|Change in Weight|Weight was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to be re-weighed.|6 weeks|Intention to Treat analysis||kg||Standard Deviation|Mean
18660|NCT01804881|Secondary|Change in Blood Pressure|Blood Pressure was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to have blood pressure taken again.|6 weeks|Intention to Treat analysis||mm Hg||Standard Deviation|Mean
18955|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination||||||
18661|NCT01804881|Primary|The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.|"The EEQ is a10-item validated questionnaire measuring the degree of interaction between food intake and emotion. Scores on a scale between baseline score and score after 6 weeks was measured.~The EEQ is scored as follows:~Values: Never = ‘0’; Sometimes = ‘1’; Generally = ‘2’; Always = ‘3’ Score between 0-5: “You are a non-emotional eater. Score between 6-10: “You are a low emotional eater. Score between 11-20: “You are an emotional eater. Score between 21-30: “You are a very emotional eater. The participants completed the EEQ at baseline and it was scored. After 6 weeks the participants completed the EEQ again and it was scored again. The participants' baseline score was compared to the score at week 6. The goal was for scores to reduce. If participants' scores were higher at week 6, that could mean that the intervention was not successful. If the participants' scores were lower at week 6, that could mean that the intervention was successful."|6 weeks|Intention to Treat analysis||Scores on a scale||Standard Deviation|Mean
18662|NCT01804842|Primary|Rmax (0-24) of Plasma Glucose|Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||mg/dL||Standard Error|Least Squares Mean
18663|NCT01804842|Primary|AUC (0-24) of Plasma Glucose|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.|Evaluable Population||mg*h/dL||Standard Error|Least Squares Mean
18664|NCT01804842|Primary|Cmax of Plasma Metformin|Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng/mL||Standard Error|Least Squares Mean
18665|NCT01804842|Primary|AUC (0-24) of Plasma Metformin|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population||ng*h/mL||Standard Error|Least Squares Mean
18666|NCT01804673|Secondary|Post-Operative Phase (PPP33) Quality of Life Questionnaire Score|The PPP33 questionnaire has an overall score and 8 subscales that represent different aspects of the post-operative quality of life: information, autonomy, communication, physical complaints, pain, rest, fear and accommodation. Answers to individual question are scored with values 1 to 4. Summary scores are calculated by adding values for each question. Subscores ranges depend on the number of questions evaluated (2 to 7 questions). The overall score ranges from 1 to 100. Higher scores indicate less pain.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||units on scale||Standard Deviation|Mean
18667|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Participant Questionnaire Responses|Participants were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: A- Is IONSYS easy to use, B- Were you able to operate the system by yourself after receiving instructions, C- Have you found button yourself, D- Was pressing button easy, E- Have you heard system’s beeps, F- Was IONSYS IM easy to understand, G- Did IM help you to use system, H- Did you have problems falling asleep, I- Could you move easily in bed, J- Did system bother you during physiotherapy, K- Do you perceive use of such system as modern treatment standard.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.||percent of participants|||Number
18668|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses|Nursing staff were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: IM A- Was IM easy to understand, B- Did IM help you to use system properly; IONSYS PCA A- Is system easy to handle, B- Did participant need help in using system, C- Do you feel confident using IONSYS; IV PCA- Are you experienced in using IV PCA; IONSYS PCA D- Could participant get mobilized sooner, E- Does participant move more, F- Is participant less afraid of moving, G- Were hospital logistics for IONSYS easier to handle.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.||percent of participants|||Number
18669|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Physician Questionnaire Responses|Physicians were asked to evaluate the IM for fentanyl-ITS (IONSYS) by responding to following questions of a questionnaire: Part2 D- Would you use IONSYS again, E- Would you prefer IONSYS to intravenous patient controlled analgesia (IV PCA); Part3 A- Was IM easy to understand, B- Did IM help you to use system properly.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percent of participants|||Number
18716|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18670|NCT01804673|Secondary|Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization|Physicians were asked to rate the participant’s ability to undergo physiotherapy or mobilization by responding to following questions of a questionnaire: Part 1 A- Does the surgical procedure performed allow the mobilization of the participant, C- Was the mobilization of the participant limited due to pain, D- Is the participant in a condition to undergo physiotherapy; Part 2 A- Was it possible to mobilize the participant sooner than with other pain therapies, B- Does the participant move more, C- Is the participant less afraid of moving. For Part 1-Question C, ‘Partial’ indicates that mobilization of participant was moderately limited due to pain.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatmentat least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies participants evaluable at specified time point for specified item.||percent of participants|||Number
18671|NCT01804673|Secondary|Percentage of Participants With Nursing Staff Global Assessment of Pain|Nursing Staff were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.||percent of participants||95% Confidence Interval|Number
18672|NCT01804673|Secondary|Percentage of Participants With Physician Global Assessment of Pain|Physicians were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.||percent of participants||95% Confidence Interval|Number
18673|NCT01804673|Secondary|Percentage of Participants With Global Assessment of Pain at Hour 48 and 72|Participants were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||percent of participants||95% Confidence Interval|Number
18674|NCT01804673|Secondary|Time to Mobilization|Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.|Baseline, Hours 24, 48 and 72|Data was not statistically summarized but reported in individual participant listing. Due to excessive missing data it was not possible to calculate valid results for the different stages of mobilization.|||||
18675|NCT01804673|Secondary|Time Spent Out of the Bed Per Day by the Participant|Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||minutes||Standard Deviation|Mean
18676|NCT01804673|Secondary|Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72|Nursing staff asked the participants to rate their current pain intensity on 11-point NRS (range 0 to 10, 0= no pain; 10= strongest pain imaginable).|Baseline, Hour 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||units on scale||Standard Deviation|Mean
18677|NCT01804673|Secondary|Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4|Number of hours per day with average pain intensity less than or equal to 4 was measured on a 11-point Numeric Rating Scale (NRS) (range 0 to 10, 0=no pain; 4=mild pain; 10=strongest pain imaginable). If the participant was sleeping at time of measurement, pain intensity was assumed to be less than or equal to 4.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.||hours||Standard Deviation|Mean
18678|NCT01804673|Primary|Percentage of Participants With Global Assessment of Pain at Hour 24|Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hour 24|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit.||percent of participants||95% Confidence Interval|Number
18679|NCT01804140|Primary|Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples|FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.||participants|||Number
18956|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 16 to 19 months post-vaccination||||||
18680|NCT01804140|Primary|Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type|Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer [μm] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population.||percentage of participants||95% Confidence Interval|Number
18681|NCT01804062|Secondary|ME +/- 1 Breath Per Minute, Max-N Sensor|The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continuous monitoring|||BrPM||Standard Deviation|Mean
18682|NCT01804062|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continous monitoring|||BrPM||Standard Deviation|Mean
18683|NCT01803737|Secondary|Autonomous and Controlled Motivation|At week 12, participants completed the 13-item TSRQ to assess motivation to continue to participate in the program if given the opportunity. The TSRQ represents participants’ reasons for continuing participation in a weight loss program via participants’ endorsement of statements of autonomous and controlled motivation. Responses were given using a 7-point Likert scale (1 = not at all true to 7 = very true). The responses on the autonomous items (5) and controlled items (8) were averaged.|Week 12|||units on a scale||Standard Deviation|Mean
18684|NCT01803737|Secondary|Change in Weight Loss Self-efficacy|Self-efficacy for weight loss was assessed at week 0 and 12 using a 20-item Weight Efficacy Lifestyle Questionnaire (WEL). The total score ranges from 0-180. Higher values represent greater beliefs toward the completion of weight management behaviors.|Week 0 and 12|||units on a scale||Standard Deviation|Mean
18685|NCT01803737|Secondary|Completion of Self-monitoring of Dietary Intake and Physical Activity|The frequency that participants engaged in the self-monitoring of dietary intake and physical activity was assessed at week 12. The diaries were completed weekly throughout the study.|Week 0 and 12|||percentage of diaries completed|Participants|Standard Deviation|Mean
18686|NCT01803737|Secondary|Change in Dietary Intake: % Carbohydrate|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||percentage of carbohydrate intake||Standard Deviation|Mean
18687|NCT01803737|Secondary|Change in Dietary Intake: % Protein|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||percentage of protein intake||Standard Deviation|Mean
18688|NCT01803737|Secondary|Change in Dietary Intake: % Fat|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||percentage of fat intake||Standard Deviation|Mean
18689|NCT01803737|Secondary|Change in Dietary Intake: Kcals/Day|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12|||kcals/day||Standard Deviation|Mean
18690|NCT01803737|Secondary|Change in Physical Activity|A questionnaire will be used to measure and quantify energy expenditure from physical activity.|Week 0 and 12|||kcals/wk||Standard Deviation|Mean
18691|NCT01803737|Primary|Change in Body Weight|Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.|Week 0 and 12|||kg||Standard Deviation|Mean
18692|NCT01802632|Secondary|Best Objective Response (BOR) for 80mg AZD9291 Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by investigator assessment) at baseline.||% of participants|||Number
18693|NCT01802632|Primary|Objective Response Rate (ORR) for Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.||% of participants||95% Confidence Interval|Number
18717|NCT01802151|Secondary|Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)|Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).|6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||log CFU/g||Standard Error|Mean
18694|NCT01802632|Secondary|Progression-Free Survival (PFS) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||months||95% Confidence Interval|Median
18695|NCT01802632|Secondary|Duration of Response (DoR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||months||95% Confidence Interval|Median
18696|NCT01802632|Primary|Best Objective Response (BOR) for Dose Escalation Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||% of participants|||Number
18697|NCT01802632|Primary|Objective Response Rate (ORR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.||% of participants||95% Confidence Interval|Number
18698|NCT01802554|Secondary|Positive and Negative Affect Schedule|This scales contains ten items assessing Negative Affect. Items included are adjectives, such as “distressed,” “ashamed,” and Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Lower scores represent better outcomes.|Change from Baseline Negative Affect at 8-weeks|||units on a scale||Standard Error|Mean
18699|NCT01802554|Secondary|Positive and Negative Affect Schedule|This scales contains ten items assessing Positive Affect. Items included are adjectives, such as “interested,” “strong,” and “inspired”. Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Higher scores represent better outcomes.|Change from Baseline Positive Affect at 8-weeks|||units on a scale||Standard Error|Mean
18700|NCT01802554|Primary|Interleukin-6 (IL-6)|IL-6 is one of many biomarkers represented in the inflammatory cascade which is initiated during an immune response. Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men and increasing concentrations of IL-6 have been associated with both nonfatal myocardial infarction and fatal Coronary Heart Disease (CHD) in longitudinal studies of population-based cohorts. Higher concentrations of IL-6 raise CHD risk. Blood was collected by a research nurse in the caregivers’ homes through a 22-gauge forearm catheter after a 20 min rest. Blood for IL-6 was dispensed in Ethylenediaminetetraacetic acid (EDTA) tubes and spun at 3000 g for 10 minutes at 4 to 8 degrees Celsius. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma IL-6 (Meso Scale Discovery, Gaithersburg, MD) was determined via highsensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline IL-6 at 8-weeks|||pg/ml||Standard Error|Mean
18701|NCT01802554|Primary|D-dimer|D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. High concentrations of D-dimer have been linked prospectively to onset of Coronary Heart Disease. Blood was collected by a research nurse in the caregivers’ homes through a 22 gauge forearm catheter after a 20 minute rest. Blood for D-dimer was dispensed into polypropylene tubes with 3.8 percent sodium citrate and spun at 1600 g for 10 minutes at room temperature. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma D-dimer (Asserachrom Stago, Asnieres, France) was determined via high sensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline D-dimer at 8-weeks|||ng/ml||Standard Error|Mean
18702|NCT01802554|Primary|Brief Center for Epidemiologic Studies Depression Scale (CESD)|The Brief CESD is a measure of depressive symptoms. The scale's minimum score is 0 and maximum score is 30. Lower scores represent fewer depressive symptoms and thus better outcomes.|Change from Baseline CESD at 8-weeks|||units on a scale||Standard Error|Mean
18703|NCT01802515|Secondary|Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale|Center for Epidemiological Studies-Depression. The CES-D is a 20-item self-report measure of depressive symptoms. Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60. Larger values represent more severe symptoms. It is a validated instrument with a score of 16 or more indicating clinically significant depression. The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study).|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.||units on a scale||Standard Deviation|Mean
18704|NCT01802515|Primary|Treatment Retention|The number of participants completing all 8 weeks of treatment phase.|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.||participants|||Number
18705|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires|Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).|Weeks 1, 5, and 6|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18706|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||Hours||Standard Error|Mean
18707|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18708|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18709|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18710|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18711|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18712|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18713|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18714|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18715|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18718|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.||units on a scale||Standard Error|Mean
18719|NCT01801982|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Month 12|FAS included all enrolled participants.||participants|||Number
18720|NCT01801982|Secondary|Overall Survival at Month 24|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).|||||
18721|NCT01801982|Secondary|Overall Survival at Month 12|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported.|Month 12|Full Analysis Set (FAS) included all enrolled participants.||participants|||Number
18722|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 24|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).|||||
18723|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 12|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 12|Full Analysis Set (FAS) included all enrolled participants.||participants|||Number
18724|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 24|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).|||||
18725|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 12|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 12|Full Analysis Set (FAS) included all enrolled participants.||participants|||Number
18726|NCT01801735|Primary|Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.|Baseline to Week 52/Early Termination|||participants|||Number
18727|NCT01801475|Primary|Metabolic Clearance of Ondasetron|This is a mathematical estimation of the clearance for ondasetron as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All patient data was used in the estimation process.||L/hr||95% Confidence Interval|Mean
18728|NCT01801475|Primary|Volume of Distribution Estimated Pharmacokinetic Parameter|This is an estimated pharmacokinetic parameter as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All subjects but not possible for neonates||Liters||95% Confidence Interval|Mean
18729|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 11 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter||Standard Deviation|Mean
18730|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 1 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter||Standard Deviation|Mean
18731|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 11 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter per Hour||Standard Deviation|Mean
18732|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 1 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Liter per Hour||Standard Deviation|Mean
18733|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 11 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour||Standard Deviation|Mean
18734|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 1 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour||Standard Deviation|Mean
18735|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 11 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn – tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour square*ng per ml||Standard Deviation|Mean
18736|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 1 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn – tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour square*ng per ml||Standard Deviation|Mean
18737|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per ml||Standard Deviation|Mean
18738|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per ml||Standard Deviation|Mean
18739|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per mL||Standard Deviation|Mean
18740|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hour*ng per ml||Standard Deviation|Mean
18741|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 11 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Per Hour||Standard Deviation|Mean
18957|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 7 to 9 months post-vaccination||||||
18742|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 1 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Per Hour||Standard Deviation|Mean
18743|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 11 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
18744|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 1 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
18745|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 11 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
18746|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 1 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Hours||Standard Deviation|Mean
18747|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 11 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||ng per ml||Standard Deviation|Mean
18748|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 1 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The Per-protocol (PP) population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.||Nanogram per millileter (ng per ml)||Standard Deviation|Mean
18749|NCT01801436|Primary|Number of Participants With KPS Score at Day 11 of Cycle 8|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
18750|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 7|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
18751|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 5|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 5|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
18762|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
18752|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 3|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 3|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
18753|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 1|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 1|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
18754|NCT01801436|Primary|Number of Participants With Karnofsky Performance Status (KPS) Score at Baseline|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Baseline|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
18755|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 11 of Cycle 8|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.||Participants|||Number
18756|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 7|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
18757|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 5|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 5|The full analysis set (FAS) population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.||Participants|||Number
18758|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
18759|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
18760|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
18761|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
18763|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
18764|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
18765|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
18766|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
18767|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr||Full Range|Median
18768|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
18769|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
18770|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
18771|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
18772|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
18773|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as ‘Objective response rate’ in some protocols or publications.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
18774|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||weeks||Inter-Quartile Range|Median
18775|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||||
18776|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||participants|||Number
18777|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)|"Serious adverse event (SAE) is defined as one of the following:~Is fatal or life-threatening~Results in persistent or significant disability/incapacity~Constitutes a congenital anomaly/birth defect~Is medically significant~Requires inpatient hospitalization or prolongation of existing hospitalization~Note that hospitalizations for the following reasons should not be reported as serious adverse events:~Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition~Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent~Social reasons and respite care in the absence of any deterioration in the patient’s general condition"|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.||participants|||Number
18778|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)|An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient’s signed informed consent has been obtained.|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.||participants|||Number
18779|NCT01801358|Primary|Phase II: Progression Free Survival (PFS)|"The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.~Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)||||||
18780|NCT01801358|Primary|Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle|A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.|Cycle 1 (up to 28 days)|Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.||DLTs|||Number
18781|NCT01801280|Primary|Dose-normalized AUC of Mycophenolic Acid|"Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN~For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake."|Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours|||mg*h/L||Standard Deviation|Mean
18782|NCT01801124|Secondary|The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30.|Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.|30 days|The analysis population comprised all enrolled subjects.||participants|||Number
18783|NCT01801124|Primary|The Effectiveness of Abdominal Analgesia From the Infiltration Into the TAP as Measured by the Subject's Overall Postsurgical Analgesic Use|The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)|10 days|The analysis population comprised all enrolled subjects.||mg (morphine equivalents)||Standard Deviation|Mean
18784|NCT01801111|Secondary|Percentage of Participants With CNS Progression As Assessed by IRC Based on RECIST|CNS progression was defined as the percentage of participants who developed a new CNS lesion or have disease progression in pre-existing CNS lesions based on IRC review of radiographs by RECIST version 1.1. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at lease 5 mm, progression of existing non-target lesions, or presence of new lesion|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population||percentage of participants|||Number
18958|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 16 to 19 months post-vaccination||||||
18959|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 16 to 19 months post-vaccination||||||
18785|NCT01801111|Secondary|Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RANO|Duration of response in participants with CNS response was defined as the time from the first observation of a CNS response (CR or PR) until first observation of CNS progression or death from any cause based on IRC review of radiographs by RANO criteria. CR and PR were as defined in outcome 39. Progression was defined by any of the following: at least 25% increase in sum of products of diameters of measurable enhancing (measurable) lesions compared to best response after initiation of therapy (nadir), or screening if screening was nadir value on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR non-enhancing lesions not caused by co-morbid events on stable or increasing doses of corticosteroids; Any new lesions; Clear progression of enhancing non-measurable disease. Clinical deterioration not attributable to other non-tumour causes. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline who achieved a CNS response of CR or PR according to IRC.||months||95% Confidence Interval|Median
18786|NCT01801111|Secondary|Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RECIST|Duration of response in participants with CNS response was defined as the time from the first observation of a CNS response (CR or PR) until first observation of CNS progression or death from any cause based on IRC review of radiographs by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the screening sum diameters) and no progression of target lesions. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at lease 5 mm, progression of existing non-target lesions, or presence of new lesion. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline and who achieved a CNS response of CR or PR according to IRC.||months||95% Confidence Interval|Median
18787|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on Radiology Assessment in Neuro-Oncology (RANO) Criteria|Objective response (CR and PR) of CNS lesions was assessed based on IRC review of radiographs by RANO criteria. CR was achieved if all of the following criteria met: Complete disappearance of all enhancing measurable and non-measurable disease; Stable or improved non-enhancing (T2/FLAIR) lesions; No new lesions; Participant must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. PR was achieved if all of the following criteria met: at least 50% decrease compared with screening in the sum of the products of the diameters (SPD) of measurable enhancing measurable lesions; No progression of non-measurable disease (enhancing and non-enhancing [T2/FLAIR] lesions); No new lesions; Participant must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. For both CR and PR, responses had to be sustained for at least 4 weeks.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline according to IRC.||percentage of participants||95% Confidence Interval|Number
18788|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on RECIST|Objective response (CR and PR) of CNS lesions was assessed based on IRC review of radiographs by RECIST version 1.1 in participants with measurable CNS lesions at baseline. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the screening sum diameters) and no progression of target lesions.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants measurable CNS lesions at baseline according to IRC.||percentage of participants||95% Confidence Interval|Number
18789|NCT01801111|Secondary|Percentage of Participants Achieving CR, PR or Stable Disease (SD, Lasting ≥16 Weeks) in Response Evaluable Population|Disease control (CR,PR or SD) was measured by RECIST version 1.1. by IRC and Investigator. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size is <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.|Baseline; every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reasons deemed by the investigator, or data cutoff (18 August 2014, maximum follow up 53 weeks)|RE population. Here, 'n' signifies participants with measurable disease at baseline for specified category.||percentage of participants||95% Confidence Interval|Number
18790|NCT01801111|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline up to death (any cause) or data cutoff (18 August 2014, maximum follow up 53 weeks)|Safety population||months||95% Confidence Interval|Median
18823|NCT01800916|Primary|Degree of Leakage|"The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.~The subjects had to tick off one of the following choices:~No leakage~Starting to leak~Leakage~Sudden Leakage"|one week|The subjects were randomized to one of nine possible treatment groups. Each treatment group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for.||percentage of baseplates with no leakage|Participants||Number
18791|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants|Objective response was assessed by IRC according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC). Number of participants analyzed=participants from RE population (IRC) who received prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
18792|NCT01801111|Secondary|Percentage of Participants Who Died||Baseline up to death (any cause) or data cut off (18 August 2014, maximum follow up 53 weeks)|Safety population||percentage of participants|||Number
18793|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population|Objective response was assessed by IRC according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC): all participants with measurable disease at baseline according to the IRC, who had baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
18794|NCT01801111|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 10 Hour Post-dose (AUC[0-10]) of Alectinib||Day 1 and Day 21 of Cycle 1|Data for this endpoint was not collected, as planned, because Part I of this study was not conducted.|||||
18795|NCT01801111|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Progression (according to RECIST version 1.1) was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion. Progression was assessed by IRC and by the investigator in safety population as well as in subgroups of participants who received prior chemotherapy and who did not receive prior chemotherapy. PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|"Safety population. Here, n signifies the number of participants evaluable for specified category."||months||95% Confidence Interval|Median
18796|NCT01801111|Secondary|Percentage of Participants With Progression or Death|Progression (according to RECIST version 1.1) was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion. Progression was assessed by IRC and by the investigator in safety population as well as in subgroups of participants who received prior chemotherapy and who did not received prior chemotherapy.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|"Safety population. Here, n signifies the number of participants evaluable for specified category."||percentage of participants|||Number
18797|NCT01801111|Secondary|Duration of Response|Duration of response was defined as the time from the first observation of an objective tumor response until first observation of disease progression using RECIST version 1.1 or death from any cause. Duration of response was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley. Duration of response was assessed by IRC and by investigator as well as in subgroups of participants who received prior chemotherapy and who did not received prior chemotherapy.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population: participants with measurable disease at baseline, had baseline tumor assessment and received at least one dose of alectinib. Number of participants analyzed= participants with measurable disease at baseline and had objective response. n=participants with measurable disease at baseline and had objective response for specified category||months||95% Confidence Interval|Median
18798|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Naive Participants|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (investigator). Number of participants analyzed=participants from RE population (investigator) who did not receive prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
18824|NCT01800903|Primary|Overall Discomfort During Catheterization|Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.|1 day|||cm||Standard Deviation|Mean
18825|NCT01800890|Primary|Degree of Leakage|"The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S.~The 4-point leakage scale has four choices~No leakage~Starting to leakage~Leakage~Sudden leakage~Leakage was assessed at every baseplate change"|10 days|||units on a scale|Participants|Standard Deviation|Mean
18799|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Pretreated Participants|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (investigator). Number of participants analyzed=participants from RE population (investigator) who received prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
18800|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Response Evaluable Population|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (Investigator): all participants with measurable disease at baseline according to the investigator, who had baseline tumor assessment and received at least one dose of alectinib.||percentage of participants||95% Confidence Interval|Number
18801|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Naive Participants|Objective response was assessed by IRC according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC). Number of participants analyzed=participants from RE population (IRC) who did not receive prior chemotherapy.||percentage of participants||95% Confidence Interval|Number
18802|NCT01801111|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|DLTs were to be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.3. DLTs: drug-related toxicities that meet any one of the following criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia continuing for ≥7 consecutive days or neutropenic fever; Non-hematological toxicity of Grade 3 or higher; Adverse events that require interruption of treatment for a total of ≥7 days.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).|||||
18803|NCT01801111|Primary|Recommended Phase II Dose of Alectinib|RP2D was to be determined based on the safety and tolerability profile of the study treatment.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).|||||
18804|NCT01800968|Secondary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.|Baseline to 180 days|All randomized subjects.||rank||Standard Deviation|Mean
18805|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP|Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days|Baseline to 180 days|All randomized subjects.||weighted average of ratio to baseline||Standard Deviation|Mean
18806|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Heart Failure Hospitalization|Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days|Randomization to 180 days|All randomized subjects.||participants|||Number
18807|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Mortality|Individual component of the primary endpoint of mortality at 180 days after randomization|Randomization to 180 days|All randomized subjects.||participants|||Number
18808|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 180 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
18809|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
18810|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
18811|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to day 180|All randomized subjects.||units on a scale||Standard Deviation|Mean
18812|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
18813|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.||units on a scale||Standard Deviation|Mean
18814|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 180 days.|Baseline to 180 days|All randomized subjects.||meters||Standard Deviation|Mean
18815|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 90 days.|Baseline to 90 days|All randomized subjects.||meters||Standard Deviation|Mean
18816|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to day 30|Baseline to day 30|All randomized subjects.||meters||Standard Deviation|Mean
18817|NCT01800968|Secondary|Change in Lateral Filling Pressure|Change in lateral filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.||m/sec||Standard Deviation|Mean
18818|NCT01800968|Secondary|Change in Medial Filling Pressure|Change in medial filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.||m/sec||Standard Deviation|Mean
18819|NCT01800968|Secondary|Change in Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline to day 180|Baseline to 180 days|All randomized subjects.||percent||Standard Deviation|Mean
18820|NCT01800968|Secondary|Change in Left Ventricular End-systolic Volume Index|Change in left ventricular end-systolic volume index from baseline to day 180.|Baseline to 180 days|All randomized subjects.||ml per meter squared||Standard Deviation|Mean
18821|NCT01800968|Secondary|Change in Left Ventricular End-Diastolic Volume Index|Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.|Baseline to 180 days|All randomized subjects.||ml per meter squared||Standard Deviation|Mean
18822|NCT01800968|Primary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.|Randomization to 180 days|All randomized subjects.||rank||Standard Deviation|Mean
18826|NCT01800318|Secondary|Duration of Crying During Heel Stick|Any crying during the heel stick procedure was timed in seconds.|5 minutes +/- 2 minutes|Newborn infants during heel stick procedure, crying timed in seconds||seconds||Standard Deviation|Mean
18828|NCT01800318|Secondary|Change in Heart Rate Variability During Heel Stick|Changes in Heart Rate Variability (HRV) were evaluated using the DL 900 monitor with 3-channel output with 5 leads. Premature infant leads from Braemar, Incorporated, were used with the DL 900 monitor. Leads were applied to the infant's chest before initiation of the TENS unit and the heel stick. The DL300 Holter Monitor will started recording HRV within 10 minutes of TENS unit initiation and the heel stick procedure and continued recording during the procedure and for 2 minutes afterwards.|Baseline, 20 minutes +/- 5 minutes|Newborn infants||LF/HF ratio||Standard Deviation|Mean
18829|NCT01800318|Secondary|Change in Salivary Cortisol After Heel Stick|Salivary cortisol was obtained prior to initiation of heelstick procedure, and at 5±0.5 minutes after procedure by gentle insertion in the mouth of a soft applicator (Salimetrics Infant Swab). The samples were stored at -20 degrees, and were analyzed at UAMS.|Baseline and 5±0.5 minutes after heel stick|||ng/ml||Standard Deviation|Mean
18830|NCT01800318|Primary|Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze.|"The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged.~Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported.~Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain."|Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged..|Analysis of PIPP scores assigned during heelstick procedure in newborn infants||units on a scale (PIPP score)||Standard Deviation|Mean
18831|NCT01799720|Secondary|Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||Units / litre||Standard Error|Mean
18832|NCT01799720|Secondary|Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||milligram / decilitre||Standard Error|Mean
18833|NCT01799720|Secondary|Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||milligram / decilitre||Standard Error|Mean
18834|NCT01799720|Secondary|Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||milligram / decilitre||Standard Error|Mean
18835|NCT01799720|Secondary|Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||millimetres of mercury||Standard Error|Mean
18836|NCT01799720|Secondary|Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||millimetres of mercury||Standard Error|Mean
18837|NCT01799720|Secondary|Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||ratio*100||Standard Error|Mean
18838|NCT01799720|Secondary|Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||kilogram / square metre||Standard Error|Mean
18839|NCT01799720|Secondary|Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the height of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||metres||Standard Error|Mean
18840|NCT01799720|Primary|Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.|Days 1 and 30|||kilogram||Standard Error|Mean
18841|NCT01799590|Secondary|Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score|The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Final evaluation (FE) was done at Day 225 or at discontinuation.|Baseline (28 days before randomization) and FE (Day 225/early discontinuation)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
18842|NCT01799590|Secondary|Percentage of Participants With Response to Treatment|Responders were defined as participants who had a 50 percent or more reduction in frequency of migraine attacks. Migraine is common disabling headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 characteristics: unilateral location, pulsating quality, moderate/severe pain or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (attack with reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes).|Baseline (28 days before randomization) up to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Percentage of participants|||Number
18960|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 16 to 19 months post-vaccination||||||
18843|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period|If aura of migraine, migraine attack or non-migraine headache attack occurred in study, these rescue drugs were permitted:analgesics, non-steroidal anti-inflammatory drugs (NSAIDs),ergotamines,triptans,antiemetics. Drugs with restricted treatment days of less than (<) 15 days per month (28 days):analgesics, NSAIDs,combination of rescue drugs and those with <10 days per month:triptans,ergotamines, opioids,combination analgesics. Average calculated as total number of monthly rescue-drug treatment days divided by the total number of days of assessment and multiplied by 28, where a month = 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
18844|NCT01799590|Secondary|Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Day 197 to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
18845|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period|As per 48-hour rule, if the symptom of pain because of migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
18846|NCT01799590|Secondary|Change From Baseline in the Average Number of Migraine Attacks According to the Diagnostic Criteria of the International Headache Society Per Month in Continuous Treatment Period|Migraine has 2 major subtypes: migraine without aura (minimum 5 attacks of headache lasting for 4-72 hours, has 2 of these characteristics [unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity] and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (2 attacks of headache with typical aura with migraine headache or typical aura with non-migraine headache or typical aura without headache or familial hemiplegic migraine or sporadic hemiplegic migraine or basilar-type migraine).|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
18847|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period|Migraine headache day was defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Average was calculated as total number of monthly headache days divided by total number of days of assessment and multiplied by 28, where a month was considered to last 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
18848|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period|Migraine:disabling headache disorder;2 major subtypes:migraine without aura(at least 5 attacks for 4-72 hours with at least 2 characteristics: unilateral location,pulsating quality,moderate/severe pain intensity or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia,phonophobia);migraine with aura(attack with reversible focal neurological symptoms that develop over 5-20 minutes, last for less than 60 minutes);average=total number of migraine attack days divided by total number of days of assessment and multiplied by 28,where a month=28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
18849|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) was less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
18850|NCT01799590|Primary|Number of Participants With Adverse Events|An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Baseline up to 28 days after last dose of study drug|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
18961|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 16 to 19 months post-vaccination||||||
18851|NCT01799239|Primary|Leakage (Percentage of All Baseplates With Leakage)|"leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate.~The subjects tick of one of the four possible answers:~No leakage~Starting to leak (leakage under the baseplate)~Leakage (seepage of faeces resulting in leakage on clothes)~Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)"|After each baseplate change over a period, of 7 days|||percentage baseplates with leakage|Participants||Number
18852|NCT01799226|Other Pre-specified|Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.|A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.|Baseline to 35 Days||||||
18853|NCT01799226|Other Pre-specified|Plaque Samples Will be Collected for Bacterial Species Detection.|Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.|Baseline to 35 Days||||||
18854|NCT01799226|Other Pre-specified|Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.|Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).|Baseline to 35 Days||||||
18855|NCT01799226|Primary|Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35|Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).||units on a scale||Standard Error|Mean
18856|NCT01799226|Secondary|Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35|Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).||units on a scale||Standard Error|Mean
18857|NCT01798966|Other Pre-specified|Adverse Events and Serious Adverse Events|Safety will be evaluated throughout the duration of the study by collecting all adverse events|4 days|||Number of AE|||Number
18858|NCT01798966|Secondary|IOP Patterns|The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients|24 hours|||mvEq||Standard Deviation|Mean
18859|NCT01798966|Primary|Change in IOP Before and After Orbital Decompression Surgery|To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression|24 hours|||mVEq (Sensismed Triggerfish output unit)||Standard Deviation|Median
18860|NCT01798927|Other Pre-specified|Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment|data from 3 of the 4 participants was analyzed||meters||Standard Deviation|Mean
18861|NCT01798927|Secondary|Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.|EMG data was analyzed from 3 of the 4 participants||participants|||Number
18862|NCT01798927|Primary|Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment|step length was analyzed from the GAITRite||cm||Standard Deviation|Mean
18863|NCT01798706|Secondary|Percentage of Participants With Gastrointestinal Disorders||Up to Day 171|Analysis was performed on safety population.||percentage of participants|||Number
18864|NCT01798706|Secondary|Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 24|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.||percentage of participants|||Number
18865|NCT01798706|Secondary|Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)|Analysis was performed on safety population defined as all randomized participants who received any amount of study drug.||percentage of participants|||Number
18866|NCT01798706|Secondary|Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)|Change in basal insulin dose was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline basal insulin dose assessment during on-treatment period.||units||Standard Error|Least Squares Mean
18867|NCT01798706|Secondary|Change in Plasma Glucose Excursions From Baseline to Week 24|Plasma glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the liquid standardized breakfast meal test, before study drug administration. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants=participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
18868|NCT01798706|Secondary|Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 mg/dL (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >9%.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
18869|NCT01798706|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
18870|NCT01798706|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||kg||Standard Error|Least Squares Mean
18871|NCT01798706|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
18872|NCT01798706|Secondary|Change in 2-Hour PPG From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
18873|NCT01798706|Primary|Absolute Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed=participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent to treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.||percentage of hemoglobin||Standard Error|Least Squares Mean
18874|NCT01798485|Secondary|Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test|"The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.~Data were not summarized due to the early termination of the study due to futility."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants|||||
18875|NCT01798485|Secondary|Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and “0” represents dead, with some health states being worse than dead (<”0”).~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|||||
18876|NCT01798485|Secondary|Participants With Treatment-Emergent Adverse Events as of 23 December 2015|"Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|up to 36 months|Safety population||participants|||Number
18877|NCT01798485|Other Pre-specified|Exploratory Biomarker Analyses|Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|up to 36 months|Randomized|||||
18878|NCT01798485|Secondary|Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015|Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.|up to 36 months|Randomized participants||percentage of participants|||Number
18879|NCT01798485|Secondary|Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015|TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment.|up to 36 months|Randomized participants||months||95% Confidence Interval|Median
18880|NCT01798485|Secondary|Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD).~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks.~Elevated LDH includes values above the upper limit of normal.~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|||||
18881|NCT01798485|Secondary|Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~Elevated LDH includes values above the upper limit of normal.~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|||||
18882|NCT01798485|Secondary|Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.~Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Elevated LDH includes values above the upper limit of normal."|up to 36 months|Randomized participants who had an elevated screening LDH||months||95% Confidence Interval|Median
18883|NCT01798485|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015|"Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis.~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants who had a confirmed response||months||95% Confidence Interval|Median
18884|NCT01798485|Secondary|Disease Control Rate (DCR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD).~CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks."|up to 36 months|Randomized participants||percentage of participants||95% Confidence Interval|Number
18885|NCT01798485|Secondary|Objective Response Rate (ORR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).~CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants||percentage of participants||95% Confidence Interval|Number
18887|NCT01798485|Secondary|Progression-free Survival (PFS) as of 19 October 2015|"The progression–free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.~Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|up to 36 months|Randomized participants||months||95% Confidence Interval|Median
18888|NCT01798485|Primary|Overall Survival as of 19 October 2015|Overall survival (OS) was measured from the date of randomization to the date of death from any cause.|up to 36 months|Randomized participants||months||95% Confidence Interval|Median
18889|NCT01798394|Secondary|Protocol Compliance - EDC's Completed|Compliance was measured as the number by number of EDCs completed (maximum of 84).|Gestational Week 36 - Postpartum Week 12|||EDC's completed||Standard Deviation|Mean
18890|NCT01798394|Secondary|Protocol Compliance - Doses of Medication Taken|Compliance was measured by doses of medication taken (maximum of 56).|Postpartum Week 0 - Week 12|||Doses of medication taken||Standard Deviation|Mean
18891|NCT01798394|Secondary|Compliance Determinants|This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.|Postpartum Week 12|||units on a scale||Standard Deviation|Mean
18892|NCT01798394|Secondary|Protocol Compliance - Number of Visits Attended|Compliance was measured as the number of visits attended (maximum of 5).|Gestational Week 36 - Postpartum Week 12|||Number of visits attended||Standard Deviation|Mean
18893|NCT01798394|Secondary|Number of Participants Who Relapsed at All During Postpartum (up to Day 84)|Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.|Postpartum Day 0 to 84|||participants|||Number
18894|NCT01798394|Secondary|Number of Participants Who Relapsed by Week 12 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 12 Postpartum|||participants|||Number
18895|NCT01798394|Primary|Number of Participants Who Relapsed by Week 4 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 4 Postpartum|||participants|||Number
18896|NCT01798264|Secondary|Change in Weight From Baseline to 4 Weeks||4 weeks|||kg||Standard Deviation|Mean
18897|NCT01798264|Secondary|Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline||4 weeks|||mg/dL||Standard Deviation|Mean
18898|NCT01798264|Secondary|To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus|Change in HbA1c from baseline|4 weeks|||percentage||Standard Deviation|Mean
18899|NCT01798264|Primary|Number of Subjects With Study Drug-Related Adverse Events||4 weeks|Number of subjects reporting study drug-related adverse events||participants|||Number
18900|NCT01798134|Secondary|12 Month Survival||12 months|||participants|||Number
18901|NCT01798134|Primary|Freedom From Tumor Progression at 6 Months|Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|For efficacy outcomes, there were 21 participants with imaging to assess tumor response. No imaging was available for the other participants.||participants|||Number
18902|NCT01798134|Primary|Freedom From Study Related SAE at 6 Months||Up to 6 months|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.||participants|||Number
18903|NCT01798134|Primary|Freedom From Serious Adverse Event (SAE) at 30days||Up to 30 days|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.||participants|||Number
18904|NCT01798004|Other Pre-specified|Melphalan Pharmacokinetics and the Combination of Busulfan and Melphalan AUC (Optional)|A descriptive analysis of the relationship between melphalan pharmacokinetics and the combination of busulfan and melphalan AUC with the occurrence of non-hematologic toxicities within 28 days following completion of consolidation will be assessed. In addition, the association between melphalan exposure levels as measured by the AUC and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days post-consolidation||||||
18905|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients With MYCN Non-amplified Tumors for Whom Molecular Profiling Results Can be Obtained||Within 8 weeks of diagnosis||||||
18906|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients for Whom ALK Status Can be Obtained||Within 6 weeks of diagnosis||||||
18907|NCT01798004|Other Pre-specified|Percentage of MIBG Scans Receiving Institutionally and Centrally Reviewed and Automated Advanced Assisted Scoring Platform Curie Scores Within 1 Unit of Each Other|Cohen's kappa will be calculated to evaluate the concordance in Curie scores between each of the scoring methods at each time point. Up to 160 MIBG scans are expected at diagnosis and up to 144 MIBG scans from the 90% of patients estimated to be MIBG avid are projected post-course 4 of induction therapy, for a total of up to 304 MIBG scans.|Up to week 12 (course 4 of induction therapy)||||||
18908|NCT01798004|Other Pre-specified|Percentage of Centrally Reviewed Post-course 4 MIBG Scans Reporting a Curie Score Considered to Have Been Determined in “Real Time”||Up to week 12 (course 4 of induction therapy)||||||
18909|NCT01798004|Other Pre-specified|First Dose Area Under the Curve (AUC) and Average Daily AUC for Busulfan|Relationship with occurrence of non-hematologic toxicities assessed by a descriptive analysis. Association between busulfan exposure levels as measured by the area under the curve (AUC) and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days following consolidation||||||
18913|NCT01798004|Other Pre-specified|Incidence of Non-hematologic Organ Toxicity (Grade 3 and Higher) and All Cause Mortality Graded According to CTC v4.0|Assessed by a descriptive analysis of the incidence of grade 3-5 non-hematologic toxicities (CTC v4.0) and all-cause mortality during consolidation therapy. In addition, a descriptive analysis of “late” onset grade 4-5 pulmonary and hepatic complications that occur within 180 days of the start of consolidation therapy will be examined, regardless if the patient has proceeded to other therapy (including chimeric antibody) during that 180 day period.|Up to 180 days||||||
18914|NCT01798004|Primary|The Tolerability of BuMel Regimen|Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome [SOS] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria [CTC] v.4.0) during the Consolidation phase of therapy.|Up to 28 days post-consolidation therapy|All eligible and evaluable patients who received at least one dose of either busulfan or melphalan.||participants|||Number
18915|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses|Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.|Up to Day 30|This reporting group includes all randomized and dispensed participants who completed the study.||participants|||Number
18916|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses|Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the ’normal’ visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.|Up to Day 30|This analysis population includes all randomized and dispensed participants who completed the study.||participants|||Number
18917|NCT01797783|Primary|Subjective Overall Vision|"The participant was instructed to, Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision. The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent)."|Up to Day 30|"This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm.~group,"||Units on a scale||Standard Deviation|Mean
18918|NCT01797705|Primary|% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study|The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an “agree” or “disagree.” Pressure changes might show no change, increase or decrease during the 20-minute epoch.|1 night|Subjects completing the study with evaluable results||percentage of agreement||95% Confidence Interval|Number
18919|NCT01797536|Primary|Apparent Terminal Half-Life (t1/2) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the t1/2 of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||hr||Geometric Coefficient of Variation|Geometric Mean
18920|NCT01797536|Primary|Time to Maximum Concentration (Tmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||hour (hr)||Full Range|Median
18921|NCT01797536|Primary|Concentration at 24 Hours (C24) After Dosing Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.|Hour 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||nM||95% Confidence Interval|Geometric Mean
18922|NCT01797536|Primary|Maximum Concentration (Cmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||nM||95% Confidence Interval|Geometric Mean
18923|NCT01797536|Primary|Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||μM•hr||95% Confidence Interval|Geometric Mean
18962|NCT01797029|Secondary|The Viral Etiologies of Acute Respiratory and Febrile Illness||Through 16 to 19 months post-vaccination||||||
18924|NCT01797536|Primary|Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.||μM•hr||95% Confidence Interval|Geometric Mean
18925|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
18926|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
18927|NCT01797445|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
18928|NCT01797445|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
18929|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 96 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
18930|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
18931|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
18932|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
18933|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
18934|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
18935|NCT01797445|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
18936|NCT01797445|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
18937|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.||cells/µL||Standard Deviation|Mean
18938|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.||cells/µL||Standard Deviation|Mean
18939|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48 and 96|Full Analysis Set||percentage of participants|||Number
18940|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Full Analysis Set||percentage of participants|||Number
18941|NCT01797445|Primary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants were randomized and received at least one dose of study drug||percentage of participants|||Number
18963|NCT01797029|Secondary|The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens||Through 16 to 19 months post-vaccination||||||
18943|NCT01797094|Secondary|Percentage of Participants Mostly or Very Satisfied With Their Crow’s Feet Lines on the Facial Line Satisfaction Questionnaire|Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
18944|NCT01797094|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.||percentage of participants|||Number
18945|NCT01797094|Secondary|Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: “My facial lines make me look tired” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 8 scores ≥ 3 at Baseline were included in the analysis.||percentage of participants|||Number
18946|NCT01797094|Secondary|Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: “My facial lines make me look less attractive than I want to look” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 5 scores ≥2 at Baseline are included in the analysis.||percentage of participants|||Number
18947|NCT01797094|Secondary|Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : “When I look in the mirror, my facial lines make me look older than I want to look” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 2 scores ≥2 at Baseline are included in the analysis.||percentage of participants|||Number
18948|NCT01797094|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow’s Feet Lines (SGA-CFL)|Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
18949|NCT01797094|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
18950|NCT01797081|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.||percentage of participants|||Number
18951|NCT01797081|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow’s Feet Lines|Participants rated the change in their Crow's Feet Lines using the Subject’s Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
18952|NCT01797081|Secondary|Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A|The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, all enrolled participants, with data available for analysis.||percentage of participants|||Number
18953|NCT01797081|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.||percentage of participants|||Number
18954|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (All Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination||||||
18970|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.||units on a scale||Full Range|Mean
18971|NCT01796977|Secondary|To Assess Pain Using the Numerical Rating Scale|"Numerical Rating Scale (NRS) - range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|30 days|There is just one NRS value calculated for the indicated time-frame, and thus a comparison between study groups with respect to this outcome was not made. The single NRS value at 30 days is reported here. One patient did not provide follow-up data at this time-point, and thus the total number of participants is 26 instead of 27 for this outcome.||units on a scale||Standard Deviation|Mean
18972|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
18973|NCT01796977|Primary|Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy|Wound Complication Rate|30 days|Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing.||breasts|Participants||Number
18974|NCT01796964|Secondary|Central Subfield Thickness (CSFT) Change From Baseline by Visit|CSFT (average thickness in the central subfield centered at the fovea) as measured using Spectral-Domain Optical Coherence Tomography (SD-OCT). Reduction in CSFT measurement from baseline indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||microns||Standard Deviation|Mean
18975|NCT01796964|Secondary|Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. This outcome measure was pre-specified for ESBA1008 arm only. One eye (study eye) contributed to the analysis.|Week 36, Week 44, Week 48, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18976|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following Treatment by Visit|The purpose of this outcome measure was to assess the potential treatment needs present at these treatment visits. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18977|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month|The purpose of this outcome measure was to assess the stability of BCVA during the second month of 8-week/12-week treatment cycles and specifically to identify potential under treatment. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18988|NCT01796548|Secondary|Total Incontinence Episodes|Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point. This study is early terminated and there were some missing data for total incontinence which lead to decrease value of total incontinence."||Episodes||Standard Deviation|Mean
18989|NCT01796548|Secondary|Urge Incontinence Episodes|Urge incontinence episodes were reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point."||Episodes||Standard Deviation|Mean
18978|NCT01796964|Secondary|Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56|The purpose of this outcome measure was to assess the average maintenance level of BCVA following the 3 loading treatments (ie, after Week 12). BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from Week 12 to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18979|NCT01796964|Secondary|Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56|The purpose of this outcome measure was to assess the integrated effect of the treatment for different study periods and to provide more robust estimate of the absolute treatment effects. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from baseline to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18980|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) by Visit|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18981|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) to Week 16|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 16|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18982|NCT01796964|Primary|Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12|This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 12|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.||letters||Standard Deviation|Mean
18983|NCT01796860|Other Pre-specified|Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices as necessary.|6MWT will be done at the time of enrollment and week 13.|||meters||Standard Deviation|Mean
18984|NCT01796860|Secondary|Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in muscle activity would be things like large changes in amplitude of muscle firing or changes in the timing of muscle firing, for example. These would indicate changes in strength or perhaps motor learning as a result of wearing the ankle foot orthosis.|Surface EMG will be done at the time of enrollment and week 13.|||participants|||Number
18985|NCT01796860|Primary|Change in Step Length From Initial Testing to End of Study|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Computerized gait analysis will be done at the time of enrollment and week 13.|||measure of length (cm)||Standard Deviation|Mean
18986|NCT01796548|Secondary|King Health Questionnaire Score|King Health Questionnaire assesses the physical and psycho-social aspects of the disease state. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response. Lower scores indicates better outcome or response.|Baseline and Week 12|"ITT population. Here N signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
18987|NCT01796548|Secondary|Percentage of Participants With no Episodes of Urge-Urinary Incontinence|Percentage of participants with no episodes of urge urinary incontinence was reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.|Baseline, Week 4 and Week 12|Data was not reported for this OM, as data was not analyzed because of change in the planned analysis of the study.|||||
18991|NCT01796548|Secondary|Post-Void Residual Urine Volume|Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.|Baseline and Week 12|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure at a particular time point."||Milliliter (ml)||Standard Error|Mean
18992|NCT01796548|Secondary|Detrusor Leakpoint Pressure|Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure. This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).|||||
18993|NCT01796548|Secondary|Maximal Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds.|Baseline and Week 12|ITT population.||Milliliter (ml)||Standard Deviation|Mean
18994|NCT01796548|Primary|Maximal Detrusor Pressure|Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.|Week 12|The Intent-to treat (ITT) population included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.||Centimeter of water||Standard Deviation|Mean
18995|NCT01796236|Secondary|Inflammation|Max of Holgers index from day 10 to month 12 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.|Day 10 to 12 Months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||participants|||Number
18996|NCT01796236|Secondary|Surgery Time|Surgery time (minutes) was recorded|Day 0|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||minutes||Standard Deviation|Mean
18997|NCT01796236|Secondary|Wound Healing|A surgeon or a surgical nurse determined if the wound was healed or not healed.|Day 10, Weeks 3, 6, 12 and 24|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There was only a statistically significant difference between the two groups in this population at day 10.||participants|||Number
18998|NCT01796236|Secondary|Pain in the Scar and Neuropathic Pain|The subject rated the following questions ‘has the scar been painful the past few weeks’ and ‘have you had any neuropathic pain during the past weeks’ on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.|Day 10, Weeks 3, 6, 12, 24 and Month 12|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There were only statistically significant differences between the two groups in this population at 3 and 12 weeks and only regarding neuropathic pain.||units on a scale||Standard Deviation|Mean
18999|NCT01796236|Secondary|Numbness|Numbness summary analysis.|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||participants|||Number
19000|NCT01796236|Primary|Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability|"Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:~Holgers Index >=2 any time between 3 weeks to 1 year~Any overgrowth any time between 3 weeks to 1 year~Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year~Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject."|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.||participants|||Number
19001|NCT01795937|Secondary|AUC0-tz of Rosuvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
19002|NCT01795937|Primary|Cmax of Rosuvastatin|"Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
19003|NCT01795937|Primary|AUC0-∞ of Rosuvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
19004|NCT01795937|Secondary|AUC0-tz of Atorvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
21691|NCT01738971|Secondary|Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)||8 months||||||
19005|NCT01795937|Secondary|Cmax,ss of Faldaprevir (Statins Part)|Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
19006|NCT01795937|Secondary|AUCτ,ss of Faldaprevir (Statins Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
19007|NCT01795937|Primary|Cmax of Atorvastatin (Statins Part)|"Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
19008|NCT01795937|Primary|AUC0-∞ of Atorvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.|"PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).~Pharmacokinetic set (PK set): all treated subjects of the statins part that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
19009|NCT01795937|Primary|Cmax,ss (Itraconazole Part)|"Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.|PK set of the itraconazole part of this trial.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
19010|NCT01795937|Primary|AUCτ,ss (Itraconazole Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods|pharmacokinetic (PK) set of the itraconazole part of this trial. The PK set included all treated subjects of the itraconazole part that provided at least 1 observation for at least 1 primary endpoint without important protocal violations with respect to the statistical evaluation of the PK endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
19011|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant|CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Participants|||Number
19012|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician|CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Participants|||Number
19013|NCT01795898|Primary|Number of Participants Requiring Rescue Medication|Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication.|Day 30|All participants suffering from osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) and chronic (lasting a long time) low back pain and who took at least 1 dose of study medication and had at least 1 follow-up visit during the study.||Participants|||Number
19014|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Units on a scale||Standard Deviation|Mean
19038|NCT01794000|Secondary|Number of Days Hospitalized for VOC|The total length of hospitalization in days for VOC was calculated for each participant. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants who were hospitalized for VOC.||Days||Standard Error|Least Squares Mean
19039|NCT01794000|Secondary|Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke||Randomization through 24 Months|No participants had a TIA or ischemic stroke at time of analysis.|||||
19015|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The intent-to-treat (ITT) population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.||Units on a scale||Standard Deviation|Mean
19016|NCT01795716|Primary|Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose||predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose|||mcg*hr/mL||Standard Deviation|Mean
19017|NCT01795547|Secondary|Change From Baseline to Week 28 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19018|NCT01795547|Secondary|Change From Baseline to Week 28 in SWN-S Total Score|The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19019|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19020|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19021|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19022|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19079|NCT01792635|Secondary|EGP in Part B in PF-05175157 200 mg BID Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg fat free mass (FFM)/min||Full Range|Median
19023|NCT01795547|Secondary|Change From Baseline to Week 28 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19024|NCT01795547|Secondary|Investigator’s Assessment Questionnaire (IAQ) Total Score at Week 28|The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).|Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 4, 8, 16, and 28. Since the IAQ was assessed from week 4, the analysis was based on 133 and 131 patients||units on a scale||Standard Error|Least Squares Mean
19025|NCT01795547|Primary|Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.||units on a scale||Standard Error|Least Squares Mean
19026|NCT01795534|Primary|Time to Complete a 10 km Run|Time taken following consumption of beetroot shot or consumption of placebo shot|Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)|||Seconds||Standard Deviation|Mean
19027|NCT01794936|Primary|Prevalence of Intra-operative Complications|Investigators will evaluate whether any intra-operative complications resulted from the use of the VTI probe to assess safety. Specifically, this time frame is limited from the induction of anesthesia through the completion of the surgical procedure (typically ~2-3 hours)|During surgical procedure itself (~2-3 hours)|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.|||||
19028|NCT01794936|Primary|Change in SHIM Score (Score of Erectile Function) Following Surgery|Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.|8 months post-operative follow-up|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.|||||
19029|NCT01794741|Primary|Adverse Events Report|reports of treatment emergent adverse events|3 months of treatment|||event|||Number
19030|NCT01794455|Secondary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 2 candesartan arm.|Change from week 8 to week 20|MRI data could not be obtained on the one study participant due to MRI contraindications.|||||
19031|NCT01794455|Secondary|Montgomery-Asberg Depression Rating Scale|MADRS is a measure of depression severity (range 0 - 60, higher scores indicate more severe depressive symptoms). This outcome applies to the candesartan Phase 2 arm.|Week 20|||units on a scale|||Number
19032|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity (range 0 - 27, higher scores indicate more severe depressive symptoms). This applies to the candesartan Phase 2 arm.|Week 20|||units on a scale|||Number
19033|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity. This applies to the sertraline Phase 1 arm.|Week 8||||||
19034|NCT01794455|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|MADRS is a measure of depression severity. This outcome applies to the sertraline Phase 1 arm.|Week 8||||||
19035|NCT01794455|Primary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 1 sertraline arm.|Change in perfusion from baseline to week 8|Could not complete MRI.|||||
19036|NCT01794000|Secondary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention|Medical intervention was defined as any medical evaluation resulting in therapy or further investigation, as determined by a trained medical professional. Data collected from the first dose of study medication through 10 days after last dose of study medication during the double blind study period are presented below.|First Dose through 24 Months|All randomized participants who received at least one dose of drug.||Percentage of Participants|||Number
19037|NCT01794000|Secondary|Time From Randomization to First and Second VOC|Data collected through the primary completion date are presented below.|Randomization to First VOC and Second VOC respectively (up to 24 Months)|All randomized participants.||Days||95% Confidence Interval|Median
41622|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban Acylglucuronide After Three Days of 5 mg IV Daily in HRS Type 1 Patients||3 days|||hr||Standard Deviation|Mean
19040|NCT01794000|Secondary|Quarterly Rate of School Absence Due to Sickle Cell Pain|Quarterly rate of school absence due to sickle cell pain was measured through participant diaries and was calculated for each participant by summing the number of days with school absence due to sickle cell pain divided by the number of school dates in the quarter. A quarter was defined as 12 weeks. The quarterly rate was set to missing if there were more than 6 weeks of missing diary entries during a specific quarter. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All Randomized participants who are 4 years or older and have both baseline and at least one post-baseline quarterly outcome measure in any quarter. Diaries were only provided to participants 4 years and older.||Percentage of Days in a Quarter||Standard Error|Least Squares Mean
19041|NCT01794000|Secondary|Monthly Rate of Days of Analgesic Use|Monthly rate of days of analgesic use was measured through participant diaries and was calculated for each participant by summing the number of days they reported analgesic use divided by the number of diary entries completed in the month. A month was defined as 4 weeks (28 days). The monthly rate was set to missing if there were more than 14 missing entries for analgesic use in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 4 years or older and have baseline and at least one post-baseline monthly outcome measure in any month. Diaries were only provided to participants 4 years and older.||Percentage of Days in a Month||Standard Error|Least Squares Mean
19042|NCT01794000|Secondary|Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions)|RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
19043|NCT01794000|Secondary|Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome)|Acute chest syndrome was defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Acute chest syndrome that occurred within 7 days of the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
19044|NCT01794000|Secondary|Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations)|Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
19045|NCT01794000|Secondary|Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis)|A painful crisis is defined as an onset of moderate to severe pain that lasts at least 2 hours for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, ketorolac, or other analgesics prescribed by a health care provider (HCP) in a medical setting such as a hospital, clinic, emergency room visit, or telephone management. The painful crisis that occurred within 7 days from the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
19046|NCT01794000|Secondary|Monthly Mean in Faces Pain Scale-Revised Score|Each day participants selected the face on the FPS-R scale that reflected their worst pain related to sickle cell disease (SCD) on that day. Monthly mean in FPS-R score was calculated for each participant by summing the FPS-R score divided by the number of non-missing diary entries completed in the month. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. A month was defined as 4 weeks (28 days). The monthly mean in FPS-R score was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.||Units on a Scale||Standard Error|Least Squares Mean
19047|NCT01794000|Secondary|Monthly Rate of Days With Pain|Monthly rate of days with pain was measured through participant diaries using a modified version of the Faces Pain Scale-Revised (FPS-R). Each day participants selected the face on the scale that reflected their worst pain related to sickle cell disease (SCD) on that day. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. Any day the participant selected a face other than face 0 was considered a day with pain. Monthly rate of days with pain was calculated for each participant by summing the number of days reported with any pain divided by the number of non-missing diary entries completed in the month. A month was defined as 4 weeks (28 days).The monthly rate was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are present below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.||Percentage of Days in a Month||Standard Error|Least Squares Mean
19048|NCT01794000|Primary|Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC)|The VOC is a composite endpoint of painful crisis or acute chest syndrome. Events that occurred within 7 days from the prior event onset date were not counted as a new episode. Data collected through the primary completion date reported below.|Randomization through 24 Months|All randomized participants.||Number of Events per Participant-Year|||Number
19049|NCT01793285|Secondary|Time to Treatment Discontinuation With Etanercept|Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept.|Year 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||years||95% Confidence Interval|Mean
19050|NCT01793285|Secondary|Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels|Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs).|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for each parameter at specified time point.||milligram per deciliter (mg/dL)||Inter-Quartile Range|Median
19051|NCT01793285|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||mm/hr||Inter-Quartile Range|Median
19052|NCT01793285|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||milligram per milliliter (mg/mL)||Inter-Quartile Range|Median
19053|NCT01793285|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm (rounded to the nearest 0.1 cm), is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||cm||Inter-Quartile Range|Median
19054|NCT01793285|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||cm||Inter-Quartile Range|Median
19055|NCT01793285|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||cm||Inter-Quartile Range|Median
19056|NCT01793285|Secondary|Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|Participant’s fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: “How would you describe the overall level of fatigue/tiredness you have experienced?” 0=none and 10=very severe.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
19057|NCT01793285|Secondary|Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|Participant’s spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: “How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had?” 0 =none and 10 =very severe.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
19058|NCT01793285|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10, 0=none and 10=very severe participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
19080|NCT01792635|Secondary|EGP in Part B in Placebo Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg fat free mass (FFM)/min||Full Range|Median
19255|NCT01788163|Secondary|Time Since First NSCLC Diagnosis by Plasma EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Plasma Evaluable Population||Months||Standard Deviation|Mean
19059|NCT01793285|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||units on a scale||Inter-Quartile Range|Median
19060|NCT01793285|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||mm||Inter-Quartile Range|Median
19061|NCT01793285|Secondary|Number of Participants Who Received Pharmacological Treatment|Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs [NSAIDs], disease-modifying antirheumatic drugs [DMARDs], corticosteroids and other treatments including anti-tumor necrosis factor-alpha [TNFalpha] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||participants|||Number
19062|NCT01793285|Secondary|Number of Participants Who Received Non-pharmacological Treatment|Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||participants|||Number
19063|NCT01793285|Secondary|Time to Diagnosis of Ankylosing Spondylitis|Time to first diagnosis of alkylosing spondylitis was reported.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||years||Standard Deviation|Mean
19064|NCT01793285|Secondary|Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist|Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||years||Standard Deviation|Mean
19065|NCT01793285|Primary|Percentage of Participants Who Discontinued Treatment With Etanercept|Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.||percentage of participants|||Number
19066|NCT01792986|Secondary|Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.||6 weeks|||trillion cells/L||Standard Deviation|Mean
19067|NCT01792986|Secondary|Difference in HGH Between Baseline and the End of the Sixth Week.||6 weeks|||ng/mL||Standard Deviation|Mean
19068|NCT01792986|Secondary|Difference in LDL-C Between Baseline and the End of the Sixth Week.||6 weeks|||mg/dL||Standard Deviation|Mean
19069|NCT01792986|Secondary|Difference in Weight Between Baseline and the End of the Sixth Week||6 weeks|||kg||Standard Deviation|Mean
19070|NCT01792986|Primary|Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.||6 weeks|||mg/dL||Standard Deviation|Mean
19071|NCT01792830|Secondary|Hyperglycemic Events|Number of subjects that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl|3 months after discharge||||||
19072|NCT01792830|Secondary|Severe Hypoglycemic Events|Number of subjects that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl|3 months after discharge||||||
19073|NCT01792830|Secondary|Incidence Rates for Post-operative Complications|Number of complications including infections, wound infections, readmissions|3 months after discharge||||||
19074|NCT01792830|Secondary|Hypoglycemic Events|Number of subjects that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl|3 months after discharge||||||
19075|NCT01792830|Secondary|Readmission Rate to the Hospital|Number of subjects that were readmitted to the hospital 3 months after discharge|3 months after discharge|The numbers listed are reflective of the total number of subjects who remained in the study at the 3 months after discharge time period. Many of the subjects were lost to follow up or never returned for their post-operative visit.||participants|||Number
19076|NCT01792830|Primary|Efficacy, Measured by a Change in HbA1c Levels|Change in the level of HbA1c in a 1 month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.|Hospital discharge, 1 month|Most patients that completed the discharge part did so over the phone. Some of the subjects who came to the hospital for their visit had trouble getting their blood drawn for HbA1c levels.||percent of glycosylated hemoglobin||Standard Deviation|Mean
19077|NCT01792635|Secondary|Ra in Part B in PF-05175157 200 mg BID Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
19078|NCT01792635|Secondary|Ra in Part B in Placebo Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
19081|NCT01792635|Secondary|GIR in Part B in PF-05175157 200 mg BID Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/min||Full Range|Mean
19082|NCT01792635|Secondary|GIR in Part B in Placebo Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/min||Full Range|Mean
19083|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B|Criteria for PCI changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) and increase of >=25% from baseline when baseline >200 msec or increase of >=50% when baseline less than or equal to (<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) >=140 msec and increase of >=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to < 480 msec and >=480 msec, or an increase from baseline of 30 to <60 msec or >=60 msec.|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5.||Participants|||Number
19084|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B|Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (>=)30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or greater than (>) 120 beats per minute (bpm).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5||Participants|||Number
19085|NCT01792635|Primary|Number of Participants With Laboratory Test Abnormalities in Part B|Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], urine drug screen, lipid profile and very-low-density lipoproteins [VLDL], hemoglobin A1c [HbA1c], C-peptide, thyroid-stimulating hormone [TSH], Hepatitis B and C, human immunodeficiency virus [HIV], triglycerides, urine creatinine).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the Clinical Research Unit (CRU) on Day -5||Participants|||Number
19086|NCT01792635|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the clinical research unit (CRU) on Day -5||Participants|||Number
19087|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
19088|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in Placebo Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.||mg/kg BW/min||Full Range|Mean
19089|NCT01792635|Primary|Whole-body Glucose Uptake in Part A|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.||mg/kg BW/min||90% Confidence Interval|Mean
19090|NCT01792635|Primary|Rate of Appearance of Glucose (Ra) in Part A|Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.||mg/kg BW/min||Full Range|Mean
19091|NCT01792635|Primary|[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A|[6,6-2H2] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp||percentage enrichment of plasma glucose||90% Confidence Interval|Mean
19107|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time|Serum electrophoresis parameters includes albumin, alpha-1 globulin, alpha-2 globulin, beta globulin, gamma globulin was reported. Mean change from Baseline values are reported at each time points.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Percentage of concentration||Standard Deviation|Mean
19092|NCT01792635|Primary|Endogenous Gucose Production (EGP) in Part A|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp||mg/kilogram (kg) body weight (BW)/min||Full Range|Median
19093|NCT01792635|Primary|Glucose Infusion Rates (GIR) in Part A|GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp||mg/min||90% Confidence Interval|Mean
19094|NCT01791972|Secondary|Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%|Participants were classified as unprotected if the maximum percentage decrease from baseline FEV1 after exercise was more than 20%. Data represents the number of participants who were classified as unprotected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set||participants|||Number
19095|NCT01791972|Secondary|Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%|Participants were classified as protected if the maximum percentage decrease from baseline FEV1 after exercise was less than 10%. Data represents the percentage of participants who were classified as protected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set||percentage of participants|||Number
19096|NCT01791972|Primary|Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge|"A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center.~The percentage fall was defined as 100*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge.~The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant’s heart rate to ≥80% of the maximum rate for age (220 bpm–age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges."|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set||percentage change from baseline FEV1||Standard Error|Mean
19097|NCT01791894|Secondary|Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Baseline to cycle 3|||number of occurrences|||Number
19098|NCT01791894|Secondary|Patients With Progressive Disease Post Treatment by RECIST Criteria|Patients with a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|After 3 treatment cycles (approx. 61 days)|||participants|||Number
19099|NCT01791894|Secondary|Patients With Stable Disease Post Treatment|Number of patients with stable disease post treatment by RECIST criteria|After 3 cycles of treatment (approx. 61 days)|4 patients completed 3 cycles of treatment||participants|||Number
19100|NCT01791894|Primary|Percent Change in Biomarker (GLI2 Protein) Levels||baseline to day 33|We recruited patients with biopsy-confirmed metastatic basal cell carcinoma who were had progressed on SMO inhibitors such as vismodegib (GDC 0449), IPI- 926, LEQ506 and LDE225.||percentage decrease||Standard Deviation|Mean
19101|NCT01791725|Other Pre-specified|Improvement in NPI Total Scores in Subjects With NPI Score ≥1 at Baseline Baseline|The Neuropsychiatric Inventory(NPI) (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia patients. The NPI was administered at the Baseline Visit (Day 1) and at Day 28 (EOS) or ET. A decrease in score shows an improvement in symptoms.|Baseline and 4 weeks|Subjects with NPI Score ≥1 at baseline||participants|||Number
19102|NCT01791725|Other Pre-specified|Cognitive Outcome (RADD Total Score)|Rapid Assessment for Development Disabilities (RADD) The RADD test was developed from the low-difficulty items from published intelligence tests (Walsh et al 2007). It was specifically developed for evaluation of individuals with intellectual disabilities and developmental disabilities. It is a validated and reliable cognitive screening instrument that can be rapidly administered. The RADD is composed of 76 items. Each item is scored as 0 (incorrect) or 1 (correct).The test assesses a wide range of functional abilities including receptive and expressive language, orientation, registration, recall, attention, self identification, motor skills, imitation, abstract reasoning, number skills, comprehension and short-term memory to give a total score. Scores are from 0 to 76. A higher total score is correlated with a higher Cognitive Impairment level.|Baseline and 4 Weeks|||units on a scale||Standard Deviation|Mean
19103|NCT01791725|Other Pre-specified|Pharmacokinetic Assessment|Mean Plasma ELND005 Concentrations- Cmax|Baseline and 4 Weeks|||μg/mL||Standard Deviation|Mean
19104|NCT01791725|Other Pre-specified|Changes From Baseline in Abnormal Neurological Examination Results|Subjects with Abnormal Neurological Examination Results|Baseline and 4 weeks|||participants|||Number
19105|NCT01791725|Primary|Incidence of Adverse Events (TEAEs)|For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC.|4 weeks|||participants|||Number
19106|NCT01791413|Primary|Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation||Within the first 2 weeks and 3 months after surgery|||percentage of serum AMH change||Inter-Quartile Range|Median
19108|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time|Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Units/Liter||Standard Deviation|Mean
19109|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time|Mean change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides (TG), total bilirubin, direct bilirubin, glucose, creatinine, blood urea nitrogen (BUN) levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||mg/dL||Standard Deviation|Mean
19110|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time|Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||10^6 cells/microliter||Standard Deviation|Mean
19111|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time|Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Percentage of cells||Standard Deviation|Mean
19112|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time|The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||gram/dL||Standard Deviation|Mean
19113|NCT01791205|Secondary|Phase II: Number of Side Effects That Induced Transient Interruption of Treatment|Number of side effects (AEs) that induced transient interruption of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||AEs|||Number
19114|NCT01791205|Secondary|Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment|Number of side effects (AEs) that had not induced discontinuation of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||AEs|||Number
19115|NCT01791205|Secondary|Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects|Number of participants who retained in therapy without interruption due to side effects is reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Participants|||Number
19116|NCT01791205|Secondary|Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AE. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. The AE were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Participants|||Number
19117|NCT01791205|Secondary|Phase II: Mean VAS Fatigue Score Overtime|The VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Higher score indicate worsening.|At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Scores on scale||Standard Deviation|Mean
19118|NCT01791205|Secondary|Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18|Percentage of participants with change in HAQ (Delta HAQ) of >= 0.21 after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. The HAQ consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19127|NCT01791205|Secondary|Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy|Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug in combination with DMARDs before monotherapy were considered for this outcome measure.||Days||Standard Deviation|Mean
19119|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18|Mean Change From Baseline (day of the first infusion with tocilizumab as monotherapy) in the dose of corticosteroids after 3, 6, 12 and 18 months from Baseline is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||milligrams||Standard Deviation|Mean
19120|NCT01791205|Secondary|Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18|The mean change from Baseline (day of the first infusion with tocilizumab as monotherapy) in the TJC And SJC after 3, 6, 12 and 18 months is reported. The TJC and SJC were determined for 28 joint counts. The scores ranged from 0 (no disease activity) to 28 (higher/worsen disease activity), where higher scores represents higher disease activity.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.||Joints||Standard Deviation|Mean
19121|NCT01791205|Secondary|Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18|Percentage of participant achieving SDAI remission (< 3.3), after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy is reported. The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA which (based on 0-10 cm VAS, 0 = no disease activity and 10 = worst disease activity, where higher scores represent higher disease activity), and CRP. The SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19122|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18|Percentage of participants achieving CDAI remission < 2.8, after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. CDAI is the numerical sum of four outcome parameters: TJC, SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19123|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 ESR < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19124|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC (28 joints) + 0.28 square root of SJC (28 joints) + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 CRP < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19125|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained delta DAS28 ESR of >= 0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); where decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19126|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained the change in DAS28 (Delta DAS28) CRP of >=0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC 28 + 0.28 square root of SJC 28 + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP- scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19257|NCT01788163|Secondary|Number of Organs With Metastasis by Tumour EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Tumour Evaluable Population||Number||Standard Deviation|Mean
19128|NCT01791205|Secondary|Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy|Mean duration of previous treatment with a biologic drug in monotherapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug before monotherapy were considered for this outcome measure.||Days||Standard Deviation|Mean
19129|NCT01791205|Secondary|Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy|Mean dose of corticosteroids at study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received corticosteroids were considered for this outcome measure.||milligrams||Standard Deviation|Mean
19130|NCT01791205|Secondary|Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy|The percentage of participants treated with corticosteroids at enrollment is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Percentage of participants||95% Confidence Interval|Number
19131|NCT01791205|Secondary|Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy|Mean of tender and swollen joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender and swollen joints was recorded on the joint assessment as no tenderness = 0 and tenderness = 1.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available tender and swollen joints at Baseline are reported.||Joints||Standard Deviation|Mean
19132|NCT01791205|Secondary|Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm) VAS; 0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available SDAI score at Baseline are reported.||Participants|||Number
19133|NCT01791205|Secondary|Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Number of participants with CDAI scores for both the groups at study entry (baseline) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available CDAI score at Baseline are reported.||Participants|||Number
19134|NCT01791205|Secondary|Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity) where higher scores represents higher disease. The DAS28 <2.6 indicates disease remission, >=2.6 and <3.2 indicates Low disease activity, >=3.2 and <=5.1 indicates Moderate disease activity and >5.1 indicates High disease activity. Median score for DAS28 at the study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available DAS28 score at Baseline are reported.||Scores on scale||Full Range|Median
19135|NCT01791205|Secondary|Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Percentage of participants||95% Confidence Interval|Number
19136|NCT01791205|Secondary|Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy|Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.||Participants|||Number
19137|NCT01791205|Secondary|Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs, the second treatment line as the subsequent use of a different biologic drug and so on for the third, fourth, fifth and sixth treatment line. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
19138|NCT01791205|Secondary|Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy|The table below shows percentage participants who started treatment with a biologic drug in monotherapy compared with percentage of participants who stopped DMARDs while taking a biologic drug in combination.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.||Percentage of Participants||95% Confidence Interval|Number
19161|NCT01791127|Primary|12 Month Adverse Event-Free Rate for Siello Leads Implanted in the Ventricle|The percentage of participants at 12 months post-implant free from primary endpoint 2 adverse events adjudicated as related to the Siello lead.|12 Months|Participants with a ventricular Siello lead that reached the 12-month follow-up time point, and or experienced a primary endpoint 2 adverse event adjudicated as related to Siello lead, at the time of the Pre-Market analysis.||percentage of participants||95% Confidence Interval|Number
19139|NCT01791205|Secondary|Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy|The HAQ-DI is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Scores on scale||Standard Deviation|Mean
19140|NCT01791205|Secondary|Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases. Percentage of participants with comorbidity is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Percentage of participants|||Number
19141|NCT01791205|Secondary|Phase I: Median Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of RA until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Months||95% Confidence Interval|Median
19142|NCT01791205|Primary|Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18|Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At month 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19143|NCT01791205|Primary|Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy|The probabilities of participant to retain on therapy at various time points are reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.||Percentage of participants||95% Confidence Interval|Number
19144|NCT01791205|Primary|Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy|Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
19145|NCT01791205|Primary|Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
19146|NCT01791205|Primary|Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy|Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
19147|NCT01791205|Primary|Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =< 2 and > 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
19148|NCT01791205|Primary|Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy|The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =< 337 days, > 337 days, =< 336 days, > 336 days are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
19149|NCT01791205|Primary|Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. Participants with SDAI score =< 8.17 and > 8.17 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.||Participants|||Number
19162|NCT01791127|Primary|12 Month Adverse Event-Free Rate for Siello Leads Implanted in the Atrium|The percentage of participants at 12 months post-implant free from primary endpoint 1 adverse events adjudicated as related to the Siello lead.|12 Months|Participants with an atrial Siello lead that reached the 12-month follow-up time point, and/or experienced a primary endpoint 1 adverse event adjudicated as related to the Siello lead, at the time of the Pre-Market analysis.||percentage of participants||95% Confidence Interval|Number
19163|NCT01789775|Primary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|||participants|||Number
19150|NCT01791205|Primary|Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient’s global assessment (PtGA) and physician’s global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Participants with CDAI score =< 7.75 and > 7.75 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.||Participants|||Number
19151|NCT01791205|Primary|Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy|The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =< 0.28 and >2.8 milligram/deciliter (mg/dL); and ESR values =< 11 and >11 millimeters/hour (mm/hr) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
19152|NCT01791205|Primary|Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy|The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =< 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Participants with DAS28 score =< 2.6 and > 2.6 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.||Participants|||Number
19153|NCT01791205|Primary|Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy|The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =< 0.8625 and > 0.8625 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at the time of evaluation are reported.||Participants|||Number
19154|NCT01791205|Primary|Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy|The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
19155|NCT01791205|Primary|Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
19156|NCT01791205|Primary|Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.||Participants|||Number
19157|NCT01791205|Primary|Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy|Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm^2. Participants with age =<, > 59 years, height =<, > 163 cm, weight =<, > 65.85 Kg and BMI =<, > 24.98 Kg/cm^2 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
19158|NCT01791127|Primary|5 Year Individual Adverse Event Rate for Siello Leads Implanted in the Ventricle|The percentage of participants at 5 years post-implant experiencing each individual type of primary endpoint 4 adverse event adjudicated as related to the Siello lead.|5 Years||||||
19159|NCT01791127|Primary|5 Year Adverse Event-Free Rate for Siello Leads Implanted in the Ventricle|The percentage of participants at 5 years post-implant free from primary endpoint 4 adverse events adjudicated as related to the Siello lead.|5 Years||||||
19160|NCT01791127|Primary|12 Month Rate of Successful Sensing and Pacing of the Implanted System Including 1 or 2 Siello Leads|The rate of successful sensing and pacing is determined by the percentage of participants at 12 months post-implant free from unresolved primary endpoint 3 adverse events adjudicated as either 'lead undersensing or loss of sensing' or 'intermittent capture, no lead capture' and also adjudicated as related to the Siello lead.|12 Months|Participants with a Siello lead that reached the 12-month follow-up time point, and/or experienced an unresolved primary endpoint 3 adverse event adjudicated as either 'lead undersensing or loss of sensing' or 'intermittent capture, no lead capture' and also adjudicated as related to the Siello lead, at the time of the Pre-Market analysis.||percentage of participants||95% Confidence Interval|Number
19165|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years were included in the analysis; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.||IU||Standard Deviation|Mean
19166|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis and participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.||IU||Full Range|Median
19167|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)||4 years|All enrolled participants; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.||IU||Standard Deviation|Mean
19168|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years with nonmissing data were included in the analysis.||IU||Standard Deviation|Mean
19169|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis.||IU||Standard Deviation|Mean
19170|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis (All Participants)||4 years|All enrolled participants; only participants with nonmissing data were included in the analysis.||IU||Standard Deviation|Mean
19171|NCT01790828|Secondary|Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha|Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.|||||
19172|NCT01790828|Secondary|Annualized Bleeding Rates During Prophylaxis|Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)]|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.|||||
19173|NCT01790828|Secondary|Percentage of Participants Experiencing Hemorrhages During Prophylaxis||4 years|All enrolled participants; n (number) equals (=) number of participants with nonmissing values||percentage of participants|||Number
19174|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years who received on-demand therapy were included in the analysis.||IU||Standard Deviation|Mean
19175|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.||IU||Full Range|Median
19176|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.||IU||Standard Deviation|Mean
19177|NCT01790828|Secondary|Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy|Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy.|4 years|Data were not analyzed as no participants experienced rating of 'no response'.|||||
19178|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age|Response categories were excellent, good, moderate, and no response.|4 years|All enrolled participants; only participants ≥18 years who receive don-demand therapy were included in the analysis.||number of responses|Participants||Number
19179|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.||number of responses|Participants||Number
19180|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.||Number of responses|Participants||Number
19181|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age||4 years|All enrolled participants; participants aged ≥18 years who received on-demand therapy were included in the analysis.||infusions||Standard Deviation|Mean
19182|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age||4 years|All enrolled participants; only participants aged <18 years who received on-demand therapy were included in the analysis.||infusions||Standard Deviation|Mean
19183|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.||infusions||Standard Deviation|Mean
19184|NCT01790828|Primary|Percentage of Participants by Family History of Factor VIII Inhibitor||4 years|All enrolled participants.||percentage of participants|||Number
19185|NCT01790750|Primary|False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false negatives between the two systems.|at baseline|||percentage of false negative||Standard Deviation|Mean
19186|NCT01790750|Primary|False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false positives between the two systems.|at baseline|||percentage of false positives||Standard Deviation|Mean
19258|NCT01788163|Secondary|Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Tumour Evaluable Population||Months||Standard Deviation|Mean
19187|NCT01790685|Primary|Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex|Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.|4 months|All enrolled (23 CRVO and 17 BRVO) patients completed the study. All patients were injected with Ozurdex, however microarrays were run on only 11 CRVO and 17 BRVO patient samples. Microarray data from 11 CRVO and 11 BRVO patients was analyzed.||participants|||Number
19188|NCT01790633|Other Pre-specified|Proportion of Rapid Test Failures|The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).|At testing|Only patients randomized to the rapid testing arm.||proportion of participants|||Number
19189|NCT01790633|Other Pre-specified|Proportion Participating|The number of individuals accepting to participate in the study divided by the total number of individuals proposed.|At testing|||proportion of participants|||Number
19190|NCT01790633|Secondary|Access to Care|The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.|Evaluated once, up to 4 months after testing|Analysis includes only participants with positive HIV, HBV, and/or HCV results.||proportion of participants|||Number
19191|NCT01790633|Primary|Accessibility of Testing Results|The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.|Evaluated once, up to 4 months after testing|||proportion of participants|||Number
19192|NCT01790581|Secondary|Self-assessed Disability|3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-month post intervention||||||
19193|NCT01790581|Secondary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-week post intervention||||||
19194|NCT01790581|Primary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient’s score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.|Disability to 1-day post intervention|||% of total questionnaire points||Standard Deviation|Mean
19195|NCT01790581|Secondary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Change from baseline balance at 1-week post intervention||||||
19196|NCT01790581|Primary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Balance at 1-day post intervention|||% of leg length||Standard Deviation|Mean
19197|NCT01790516|Primary|Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician|"Feasibility is defined as follows:~- Patients' genetic test results are returned to the treating physician within 3 days"|20 months|||days||Full Range|Median
19198|NCT01790490|Other Pre-specified|Cocaine Use in Follow-up|Weekly assessment of cocaine use by urine toxicology and history|4-week follow up||||||
19199|NCT01790490|Other Pre-specified|Change in Physiological Reactivity|Assesses level of physiological arousal to cues using galvanic skin response|change across infusions over 9 days||||||
19200|NCT01790490|Secondary|Risk of Initiating Experimental Drug Misuse|Weekly assessment of drug use by history and urine toxicology|4 week follow-up after completion of inpatient phase||||||
19201|NCT01790490|Secondary|Acute Tolerability|Various measures ascertain level of dissociation, abuse liability, and behavioral disturbances.|immediately after each infusion over 5 days||||||
19202|NCT01790490|Primary|Change in Motivation to Quit|Motivation score obtained from the University of Rhode Island Change Assessment (URICA). Scores are obtained at baseline and at 24 hours after each infusion. The scores are 0-13, with higher scores indicating greater motivation. The analysis is within-subject. Scores included below are means; higher scores represent higher motivation to quit than do lower scores.|Baseline and 24 hours post-infusion|||units on a scale||Full Range|Mean
19203|NCT01790490|Primary|Change in Cue Reactivity|Serial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion.|Baseline and 24 hours after infusion|||units on a scale (0-200), high is worse||Standard Error|Median
19204|NCT01790178|Secondary|Number of Participants With Inadequate Biopsy Samples|The presence of an inadequate sample was determined by the blinded pathologist reading the muscle biopsies. This reflects the sample having enough preserved muscle tissue for histologic analysis. It is separate from the number of participants receiving a diagnosis. A sample may be adequate, but non-diagnostic. Only one biopsy was performed in each patients, so the number of biopsies is the same as the number of participants.|At time of pathology review|||Inadequate Biopsy Samples|||Number
19205|NCT01790178|Secondary|Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue|"For core or needle biopsies, the physician passes the needle into the muscle until they feel that adequate tissue samples have been obtained. This outcome measure is the number of passes required in each study arm."|At time of biopsy|||needle passes||Standard Deviation|Mean
19206|NCT01790178|Secondary|Number of Participants With Adverse Events Related to Muscle Biopsy|Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.|Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy|||participants|||Number
19207|NCT01790178|Primary|Number of Patients Receiving Diagnosis From Muscle Biopsy|The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.|At time of biopsy|||participants|||Number
19209|NCT01789476|Secondary|Summed Pain Intensity Differences Over 48 Hours (SPID 0-48) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug.~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 48 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.||units on a scale * hours||Standard Deviation|Mean
19210|NCT01789476|Secondary|Summed Pain Intensity Differences Over 36 Hours (SPID 0-36) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 36 hours used in calculating SPID 0-36).~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 36 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.||units on a scale * hours||Standard Deviation|Mean
19211|NCT01789476|Primary|Summed Pain Intensity Differences Over 24 Hours (SPID 0-24) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 24 hours used in calculating SPID 0-24).~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.||units on a scale * hours||Standard Deviation|Mean
19212|NCT01789255|Secondary|Plasma Concentrations of Inflammatory GVHD Markers|Summarized with means and 95% confidence intervals.|Up to day 100||||||
19213|NCT01789255|Secondary|Histone Acetylation in Peripheral Blood Stem Cells (PBMC)|Summarized with means and 95% confidence intervals.|Up to day 100||||||
19214|NCT01789255|Secondary|Relapse|Estimated with Kaplan-Meier methods.|Up to 1 year||||||
19215|NCT01789255|Secondary|Overall Survival|Estimated with Kaplan-Meier methods.|Up to 1 year||||||
19216|NCT01789255|Secondary|Steroid-free Survival|Estimated with Kaplan-Meier methods.|Up to 1 year||||||
19217|NCT01789255|Secondary|Mean Percent of Planned Dose Administered|The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.|Up to day 30|||percent of dose administered||Full Range|Mean
19218|NCT01789255|Primary|The Number of Participants That Experience Grade 2-4 Acute GVHD (Graft Versus Host Disease) by Day 100|"The incidence of grade 2-4 acute GVHD (Graft Versus Host Disease) by day 100~Grade 2 GVHD: Maculopapular rash covering 25-50% of BSA (Body Surface Area), bilirubin between 3.1-6 mg/dl, and/ or adult stool output between 1000-1500 ml/day (child between 20-30 ml/kg/day).~Grade 3 GVHD: Maculopapular rash covering >50% of BSA, bilirubin between 6.1-15 mg/dl, and/ or adult stool output >1500 ml/day (child >30 ml/kg/day).~Grade 4 GVHD: Generalized erythroderma plus bullous formation and desquamation >5% BSA, bilirubin >15 mg/dl, and/ or severe abdominal pain with or without ileus, or grossly bloody stool."|Day 100|||participants|||Number
19219|NCT01789138|Secondary|HIV-1 RNA Count / Viral Load (VL)|Undetectable viral load: HIV-1 RNA <40 copies/mL|12 months|Number of participants who completed the 12-month study||participants|||Number
19220|NCT01789138|Primary|Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)||12 months|Number of participants who completed the study||participants|||Number
19221|NCT01788566|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline up to 30 Days Post Last Infusion (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for antibodies.||participants|||Number
19222|NCT01788566|Secondary|Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab|Pre-infusion Minimum Concentration (Cmin) and post-infusion (Cmax) necitumumab serum concentration|Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1|All participants who received any amount of study treatment and had evaluable data for Cmax||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
19223|NCT01788566|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent improvement from baseline in the sum of target lesions.|Baseline until Measured Progressive Disease (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for CTS.||percent change||Standard Deviation|Mean
19256|NCT01788163|Secondary|Demographics and Disease Characteristics by Plasma EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Plasma Evaluable Population||Participants|||Number
19224|NCT01788566|Secondary|Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR is best overall response of SD, PR or CR. According to RECIST v1.1, PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Percentage of participants who achieved disease control = (those participants counted in the denominator with a best tumor response of SD, PR, or CR)/(the same denominator as for ORR)*100.|Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.||percentage of participants||95% Confidence Interval|Number
19225|NCT01788566|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)|All participants who received any quantity of study treatment.||months||95% Confidence Interval|Median
19226|NCT01788566|Secondary|Overall Survival (OS)|Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date.|Baseline to Death from Any Cause (up to 17 Months)|All participants who received any amount of study treatment. Participants censored=34.||months||95% Confidence Interval|Median
19227|NCT01788566|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.|Baseline to Measured Progressive Disease (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.||Percentage of participants||95% Confidence Interval|Number
19228|NCT01788358|Secondary|Blood Pressure Response Rate at Weeks 28 and 52|Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of <140 mmHg or a reduction of MSSBP of more than (>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of <90 mmHg or a reduction of MSDBP of >10 mmHg from baseline value).|Weeks 28 and 52|mITT||percentage of subjects|||Number
19229|NCT01788358|Secondary|Blood Pressure Control Rate at Weeks 28 and 52|Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg.|Weeks 28 and 52|mITT||percentage of subjects|||Number
19230|NCT01788358|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52||Baseline (Week 0), Weeks 28 and 52|mITT||millimeter of mercury (mmHg)||Standard Deviation|Mean
19231|NCT01788358|Secondary|Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52||Baseline (Week 0), Weeks 28 and 52|Modified intention-to-treat analysis set (mITT): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.||millimeter of mercury (mmHg)||Standard Deviation|Mean
19232|NCT01788358|Secondary|Number of Subjects With Clinically Relevant Changes in Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.|Baseline (Week 0) up to Week 52/EOS|SAF||Subjects|||Number
19233|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of study treatment up to Week 52/EOS|SAF||Subjects|||Number
19234|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 52/EOS|SAF||Subjects|||Number
19235|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of first study drug administration up to Week 28|SAF||Subjects|||Number
19236|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28|An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 28|Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.||Subjects|||Number
19237|NCT01788228|Secondary|Assessment of Psychometric Validity and Internal Consistency of the Daily SF-36v2 Questionnaire||Day 0 to Day 7 for daily SF-36v2 questionnaires||12/2020||||
19238|NCT01788228|Secondary|Assessment of the Quality of Life Measures Overall and by Age Category (18-40; 41-64; 18-64; and >64 Years of Age) Via SF-36v2® Health Assessment Questionnaires||Day 0 and Day 7, Day 21 and Day 28 for weekly SF-36v2 questionnaires and Day 0 to Day 7 for daily SF-36v2 questionnaires||12/2020||||
19239|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
19240|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events (AEs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as occurrence of any pIMD regardless of intensity grade or relation to vaccination. Related was defined as pIMD(s) considered by the investigator to have a causal relationship to vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
19241|NCT01788228|Primary|Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
19242|NCT01788228|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever [oral temperature above 38.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
19243|NCT01788228|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
19244|NCT01788215|Secondary|Total Number of Ovulations|The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.|week 24|In the sugar pill arm, one participant withdrew at week 12.||ovulations|||Number
19245|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 24|in the sugar pill arm, one participant withdrew at week 12||nmol /L||Standard Deviation|Mean
19246|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 12|||nmol/L||Standard Deviation|Mean
19247|NCT01788215|Secondary|Free Testosterone in Serum||week 24|in the sugar till arm, one participant dropped out at week 12||pg/mL||Standard Deviation|Mean
19248|NCT01788215|Secondary|Free Testosterone in Serum||week 12|||pg/mL||Standard Deviation|Mean
19249|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 12.|week 12|||ng/dL||Standard Deviation|Mean
19250|NCT01788215|Secondary|Serum Progesterone Levels in Blood|Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.|24 weeks|This measurement was not completed, because the number of ovulations was measured in its place and better indicates the effect of the treatment. See outcome measure number 8.|||||
19259|NCT01788163|Secondary|Demographics and Disease Characteristics by Tumour EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Tumour Evaluable Population||Participants|||Number
19260|NCT01788163|Secondary|Plasma EGFR Mutation Testing Turnaround Time|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population||Time (Days)||Standard Deviation|Mean
19261|NCT01788163|Secondary|Plasma EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Enrolled Population||Percentage of Participants|||Number
19262|NCT01788163|Secondary|Plasma EGFR Mutation Testing|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.|At Screening|Enrolled Population||Participants|||Number
19263|NCT01788163|Secondary|Tumour EGFR Mutation Testing Turnaround Time|Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population||Time (Days)||Standard Deviation|Mean
19264|NCT01788163|Secondary|Tumour EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.|At Screening|Enrolled Population||Percentage of Participants|||Number
19265|NCT01788163|Secondary|Tumour EGFR Mutation Testing|Frequencies of tumour EGFR mutation testing practices parameters.|At Screening|Enrolled Population||Participants|||Number
19266|NCT01788163|Secondary|Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.|At Screening|Tumour and Plasma Evaluable Population||Percentage|||Number
19267|NCT01788163|Secondary|Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.|At Screening|Tumour and Plasma Evaluable Population||Percentage|||Number
19268|NCT01788163|Secondary|Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Tumour and Plasma Evaluable Population||Percentage|||Number
19269|NCT01788163|Primary|Plasma EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country|At Screening|Plasma Evaluable Population||Percentage of participants||95% Confidence Interval|Number
19270|NCT01788163|Primary|Plasma EGFR Mutation by Subtype|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Plasma Evaluable Population||Participants|||Number
19271|NCT01788163|Primary|Overall Plasma EGFR Mutation Status|Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Plasma Evaluable Population||Percentage of participants||95% Confidence Interval|Number
19272|NCT01788163|Primary|Tumour EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population||Percentage of participants||95% Confidence Interval|Number
19273|NCT01788163|Primary|Tumour EGFR Mutation by Subtype|Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Tumour Evaluable Population||Participants|||Number
19274|NCT01788163|Primary|Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status|The 95% Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population||Percentage of participants||95% Confidence Interval|Number
19275|NCT01787838|Primary|Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients|Pneumococcal vaccination rates, tracked biweekly, following 1) staff education, audit and feedback of rates and 2) patient education|12 Months|||participants|||Number
19276|NCT01787799|Primary|In-stent Late Loss|In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)|9 month|The primary endpoint would be considered to have been met if the SYNERGY in-stent late loss was less than the performance goal of 0.40 mm. The Intent To Treat (ITT) and per protocol populations were identical.||mm||95% Confidence Interval|Mean
19277|NCT01787760|Primary|Spherical Equivalent Refraction|Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.||diopter (D)|Participants|Standard Deviation|Mean
19278|NCT01787760|Primary|Axial Length (Axial Elongation)|Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.||millimeter (mm)|Participants|Standard Deviation|Mean
19279|NCT01787591|Primary|Estimated Absorption (% Dose)|Absorption of deuterium labelled alpha-tocopherol|0-72 h post-meal|||% dose||Standard Error|Mean
19280|NCT01787591|Primary|Elimination Rate|Rate of plasma elimination of deuterium labelled alpha-tocopherol|0-72 h post-meal|||mmol/L/h||Standard Error|Mean
19281|NCT01787591|Primary|Tmax|Time to maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal|||h||Standard Error|Mean
19282|NCT01787591|Primary|Cmax|Maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal|||umol/L||Standard Error|Mean
19284|NCT01787461|Secondary|Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)|Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||micrometer||Standard Deviation|Mean
19285|NCT01787461|Secondary|Change From Baseline in Skin Thickness at Week 6, 12,18 and 24|Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."||micrometer||Standard Deviation|Mean
19286|NCT01787461|Secondary|Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24|Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||gram per square meter per hour||Standard Deviation|Mean
19287|NCT01787461|Secondary|Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24|DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||microsecond||Standard Deviation|Mean
19288|NCT01787461|Secondary|Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24|Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands – discoloration) and Body – Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
19289|NCT01787461|Secondary|Participants Improvement Assessment of Face at Week 12 and 24|Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
19290|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24|Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."||units on scale||Standard Deviation|Mean
19291|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24|Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or “bags” under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
19292|NCT01787461|Secondary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
19293|NCT01787461|Secondary|Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24|IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Week 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."||units on scale||Standard Deviation|Mean
19294|NCT01787461|Primary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."||units on scale||Standard Deviation|Mean
19295|NCT01787383|Secondary|Convenience TSQM|Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
19296|NCT01787383|Secondary|Global Satisfaction TSQM|Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
19297|NCT01787383|Secondary|Side Effects TSQM|Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
19298|NCT01787383|Secondary|Effectiveness Satisfaction Questionnaire for Medication (TSQM)|Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks|||units on a scale||Standard Deviation|Mean
19299|NCT01787383|Secondary|Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment|||percentage reduction in number of AKs||Standard Deviation|Mean
19300|NCT01787383|Secondary|Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as percentage of participatns with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment|||percentage of participants|||Number
19301|NCT01787383|Secondary|Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as percentage of participants with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment|||percentage of participants|||Number
19302|NCT01787383|Primary|Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area|"Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together Per Arm. Each subject could contribute with up to 2 values (1 for each treated area)."|3 days after treatment of each selected treatment area|||units on a scale||Standard Deviation|Mean
19303|NCT01787279|Secondary|Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72|Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. Participants available at the time of assessment were included in the analysis.||Percentage of participants|||Number
19304|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48|Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive.|At Screening and Week 48|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. ‘n’=number of evaluable participants available at specified time point.||Percentage of participants|||Number
19305|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72|Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.||Percentage of participants||95% Confidence Interval|Number
19340|NCT01786876|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents*h/ml||Standard Deviation|Mean
19306|NCT01787279|Primary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 72|Safety analysis population is defined to include only participants who receive at least one dose of study medication and have one subsequent post baseline safety assessment.||Participants|||Number
19307|NCT01787279|Primary|Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72|Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.||Percentage of participants||95% Confidence Interval|Number
19308|NCT01787279|Primary|Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported.|At Week 72|Intent-to-treat (ITT) population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.||Percentage of participants||95% Confidence Interval|Number
19309|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19310|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19311|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19312|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19341|NCT01786876|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Standard Deviation|Mean
21814|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||mg/dl|Participants|Standard Deviation|Mean
19313|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19314|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19315|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19316|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19317|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19318|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19342|NCT01786876|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Full Range|Median
19319|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19320|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19321|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19322|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19323|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19324|NCT01787188|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
19325|NCT01787175|Secondary|Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. . The secondary outcome evaluated participants’ recommendation about future monitoring of patient conditions. Participants reviewed a total of 10 patient cases and received a score of 0 or 1 point for each issue within each case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent a greater proportion of appropriate monitoring recommendations made.|10 minutes|||proportion||95% Confidence Interval|Mean
19760|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Intention to Treat)|Will assess vaginal wall histology - thickness of lamina propria.|Time of surgery, i.e. after 6-8 weeks of intervention|||microns||Standard Error|Mean
19326|NCT01787175|Primary|Accuracy of Written Assessment and Plan in Terms of Control and Status|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. The primary outcome evaluated participants’ recommendations for treatment of patient conditions. Participants reviewed a total of 10 patient cases and received a score between 0 and 3 points for each issue within each patient case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent greater accuracy of the written assessment and plan.|10 minutes|||units on a scale||95% Confidence Interval|Mean
19327|NCT01787175|Primary|Amount of Time to Complete Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.|10 minutes|58 providers were enrolled||minutes||Standard Deviation|Mean
19328|NCT01786993|Primary|Percentage of Non-responders With MPP Compared to Biventricular Pacing|"The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient’s CCS was classified as worsened, improved or unchanged based on the definitions below:~Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation~Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.~Unchanged - patient was neither improved nor worsened~For patients who were responders at the 3-month visit, those who were “Improved” and “Unchanged” between 3 and 9 months were classified as responders, whereas those who were “Worsened” were grouped together as non-responders."|3 months to 9 months|||percentage of patients|||Number
19329|NCT01786993|Primary|Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion|A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.|Implant to 9 months|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).||Event-Free Probability||95% Confidence Interval|Number
19330|NCT01786954|Secondary|Adverse Events|The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.|postoperative day #1|Adverse events were analyzed for all enrolled patients, in contrast to IOP measurements, which were only analyzed for the 50 post-vitrectomy patients.||adverse events|||Number
19331|NCT01786954|Primary|Measurement of Intraocular Pressure|The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.|postoperative day #1|Of the 68 patients enrolled, only 50 patients who received IOP measurement one day following vitrectomy surgery were analyzed. Those with IOP measurement following non-vitrectomy surgery were subsequently excluded from the analysis.||mm Hg||Standard Deviation|Mean
19332|NCT01786902|Other Pre-specified|The Change of Antibodies to Growth Hormone||baseline and 26 weeks|||ng/mL||Standard Deviation|Mean
19333|NCT01786902|Secondary|Difference of Height Standard Deviation Score Between Treatment and Non-treatment Group After 26 Weeks|The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.|26 weeks|||ratio||Standard Deviation|Mean
19334|NCT01786902|Primary|The Difference of Annualized Height Velocity Between Treatment Group and Non-treatment Group After 26 Weeks||26 weeks|||cm/year||Standard Deviation|Mean
19335|NCT01786876|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||percentage of radioactivity||Standard Deviation|Mean
19336|NCT01786876|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||percentage of radioactivity||Standard Deviation|Mean
19337|NCT01786876|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Standard Deviation|Mean
19338|NCT01786876|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Full Range|Median
19339|NCT01786876|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents/ml||Standard Deviation|Mean
19376|NCT01786330|Primary|Average Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Reported average pain level is reported as means for each participant group."|24 hours postoperative|||units on a scale||Standard Deviation|Mean
19343|NCT01786876|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents/ml||Standard Deviation|Mean
19344|NCT01786876|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg equivalents*h/ml||Standard Deviation|Mean
19345|NCT01786876|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Standard Deviation|Mean
19346|NCT01786876|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||hours||Full Range|Median
19347|NCT01786876|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg/ml||Standard Deviation|Mean
19348|NCT01786876|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.||pg*h/ml||Standard Deviation|Mean
19349|NCT01786707|Secondary|The Proportion of Subjects With a Reduction of >1% in HbA1c||at 6 months||||||
19350|NCT01786707|Primary|The Reduction in HbA1c From Time of Randomization to 1 Year After Intervention.||1 year|||reduction of A1c|||Number
19351|NCT01786668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19352|NCT01786668|Secondary|Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]).|Baseline, Week 12|FAS||Units on a scale||Standard Error|Least Squares Mean
19353|NCT01786668|Secondary|Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS||Units on a scale||Standard Error|Least Squares Mean
19354|NCT01786668|Secondary|Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12|Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||cm||Standard Error|Least Squares Mean
19355|NCT01786668|Secondary|Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12|This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Swollen Joints||Standard Error|Least Squares Mean
19356|NCT01786668|Secondary|Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History|Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).|Baseline, Week 12 and Follow-up|FAS - n=number of participants completing the Specific Medical History Assessment at each visit.||Percentage of Participants|||Number
19357|NCT01786668|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12|Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19358|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12|BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19359|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12|BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19360|NCT01786668|Secondary|Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
19361|NCT01786668|Secondary|Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19362|NCT01786668|Secondary|Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12|The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
19363|NCT01786668|Secondary|Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12|The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
19364|NCT01786668|Secondary|Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12|The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
19365|NCT01786668|Secondary|Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12|The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19377|NCT01786330|Primary|Lowest Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Lowest pain level is reported as means for each participant group."|24 hours postoperative|||units on a scale||Standard Deviation|Mean
19366|NCT01786668|Secondary|Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12|ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit||Percentage of participants|||Number
19367|NCT01786668|Secondary|Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12|ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit.||Percentage of participants|||Number
19368|NCT01786668|Secondary|Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12|Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19369|NCT01786668|Secondary|Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12|SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19370|NCT01786668|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12|SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement||Units on a scale||Standard Error|Least Squares Mean
19371|NCT01786668|Secondary|Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 2, Week 4, Week 8|FAS - n=number of responders at each visit.||Percentage of participants|||Number
19372|NCT01786668|Primary|Percentage of Participants Achieving ASAS20 at Week 12|The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 12|FAS||Percentage of participants|||Number
19373|NCT01786668|Primary|Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12|The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Week 12|Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo).||Percentage of participants|||Number
19374|NCT01786629|Primary|"Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent)"||Day of colonoscopy|The analysis population contains subjects that consumed any portion of their bowel preparation. Subject who discontinued from the study for reasons other safety of efficacy are not included (e.g. insurance issues).||percentage of subjects|||Number
19375|NCT01786330|Primary|Worst Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Worst pain level is reported as means for each participant group."|24 hours postoperative|||units on a scale||Standard Deviation|Mean
19378|NCT01786330|Secondary|Change in Hemoglobin Concentration|Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.|24 hours from baseline|||g/dL||Standard Deviation|Mean
19379|NCT01786252|Primary|Expression of hCG Target C3 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|within three years of study completion|||D-HSCORE||Standard Deviation|Mean
19380|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|within three years of study completion|||D-HSCORE||Standard Deviation|Mean
19381|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|within three years of study completion|||D-HSCORE||Standard Deviation|Mean
19382|NCT01786252|Primary|Endometrial Staging in hCG Versus Vehicle Treated Patients|All H&E-stained endometrial biopsies were analyzed in a blinded manner for endometrial dating and glandular and stromal development. Criteria for endometrial dating included the presence or absence of sub-nuclear vacuoles, which is one of the more reproducible features of the Noyes dating criteria. For the purposes of statistical analysis, the most advanced elements in each of the two endometrial compartments were considered.|within three years of study completion|||days||Standard Error|Mean
19383|NCT01786239|Primary|Treatment Response|The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms.|16 weeks|||units on a scale||Standard Error|Least Squares Mean
19384|NCT01786174|Secondary|Forced Expiratory Volume in 1 Second (FEV1) / Slow Vital Capacity (SVC) Ratio|"Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.~Slow Vital Capacity (SVC): Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal."|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.||Percentage of predicted max value||95% Confidence Interval|Mean
19385|NCT01786174|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.||Percentage of predicted max value||95% Confidence Interval|Mean
19386|NCT01786174|Primary|Change in Slow Vital Capacity Score (SVC)|The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.|Week 0, Week 2, Week 4 and Week 8|||Percentage of predicted max value||95% Confidence Interval|Mean
19387|NCT01786174|Primary|ALSFRS-R Total Score at Weeks 0, 2, 4 and 8|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 4 and Week 8|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.||scores on a scale||95% Confidence Interval|Mean
19388|NCT01786174|Secondary|Lymphocyte (T-Cell) Subset Trajectories|Gilenya (fingolimod) has been shown to successfully reduce circulating lymphocytes (a type of white blood cell) by blocking their egress (exit) from the lymph nodes. A secondary objective of the study is to quantify the effect of the treatment on circulating lymphocyte populations in patients with ALS.|Week 0, Week 2, and Week 4|||10^3/uL||95% Confidence Interval|Mean
19389|NCT01786109|Secondary|Post-Treatment Sensory Threshold for First Perception of Gas|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis||mm Hg||Standard Deviation|Mean
19390|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Sensation|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis||mm Hg||Standard Deviation|Mean
19391|NCT01786109|Secondary|Postprandial Colonic Motility Index|Colonic phasic pressure activity is summarized as a motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1]. A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostat balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis||log mm Hg||Standard Deviation|Mean
19761|NCT01778985|Secondary|Serum Estradiol Levels, Surgery||Time of surgery|||pg/mL||Standard Error|Mean
19762|NCT01778985|Secondary|Serum Estradiol Levels, Baseline||Baseline|||pg/mL||Standard Error|Mean
19392|NCT01786109|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|After 12 hour fast, before drug administered|Intention-to-treat analysis||mL||Standard Error|Mean
19393|NCT01786109|Secondary|Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions|The sensory rating was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|1 hour after drug was ingested|Intention-to-treat analysis||mm||Standard Error|Mean
19394|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Perception of Pain|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis||mm Hg||Standard Deviation|Mean
19395|NCT01786109|Secondary|Postprandial Change in Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis||mL||Standard Error|Mean
19396|NCT01786109|Primary|Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2)|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.~After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after drug was ingested|Intention-to-treat analysis||mL/mm Hg||Standard Error|Mean
19397|NCT01785628|Other Pre-specified|Change in Brain Imaging by [99mTc]TRODAT-1 From Baseline to 8 Weeks.|[99mTc]TRODAT-1 : 7 patients for treatment and placebo groups, respectively.|baseline to 8 weeks||||||
19398|NCT01785628|Other Pre-specified|Change in Brain Imaging by 18F-FDG PET From Baseline to 8 Weeks.|18F-FDG PET scan : 8 patients for treatment and placebo groups,respectively.|baseline to 8 weeks||||||
19399|NCT01785628|Secondary|Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.|The PDQ-39 contains 39-items covering 8 discrete dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each question is scored on a 5-point scale and recoded to 0 to 4 for the analysis. The total score can range from 0 to 132 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
19400|NCT01785628|Secondary|Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.|The BDI-II is a 21-item self-report questionnaire assessing the current severity of depression symptoms. Each item is scored on a scale of 0 to 3 and the total score ranges from 0 to 63. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
19401|NCT01785628|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.|The HAM-D is a 21-item rating scaled which includes an emphasis on behavioral symptoms and somatic complaints that neglects self-reported feelings of distress; and an intermingling of frequency and intensity of symptoms. The total score ranges from 0 to 64: ten items are ranked on a scale from 0 to 4; 9 items are ranked 0 to 2; and 2 items are ranked 0 to 3. With a higher score indicating more severe symptoms.|baseline to 8 weeks|||Scores on a scale||Standard Deviation|Mean
19402|NCT01785628|Secondary|Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.|The Behave-AD includes the assessment of symptoms and a global rating of caregiver distress. A total of 25 symptoms in 7 clusters are rated: paranoid and delusional ideation, hallucinations, aggressiveness, activity disturbances, diurnal rhythm disturbances, affective disturbances and anxieties, and phobias. Caregivers rate behavioral symptoms over the preceding 2 weeks on a 0 to 3 scale. The caregiver also determines a global assessment of caregiver distress on a scale of 0 to 3. The maximum score is 75 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|||Scores on a scale||Standard Deviation|Mean
19403|NCT01785628|Secondary|Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.|The NPI scale has 12 domains: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The total score ranges from 0 to 144, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
19404|NCT01785628|Secondary|Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.|The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
19405|NCT01785628|Secondary|Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.|The Cognitive Abilities Screening Instrument (CASI) has a score range of 0 to 100 and provides quantitative assessment on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment. With a higher score indicating Symptom improvement.|baseline to 8 weeks|ITT Population||Scores on a scale||Standard Deviation|Mean
19457|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 7 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (7 days) minus earliest time point.|baseline and 7 days later|||units on a scale||Standard Deviation|Mean
19406|NCT01785628|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline to 8 weeks. The UPDRS score has three parts, part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Each consisting of questions answered on a 0-4 point scale. The minimum total score possible is 0 and the maximum total score possible is 176. Higher scores indicating more severe symptoms.|baseline to 8 weeks.|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.||Scores on a scale||Standard Deviation|Mean
19407|NCT01785602|Secondary|Change From Baseline in Eczema Area and Severity Index|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 – 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 4 weeks, 8 weeks|All randomized participants||Score on a scale||Standard Error|Mean
19408|NCT01785602|Primary|Change From Baseline in Eczema Area and Severity Index (EASI)|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 – 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 12 weeks|All randomized participants||Score on a scale||Standard Error|Mean
19409|NCT01785524|Primary|Change in Exercise Capacity - Claudication Onset Time (COT)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.|Baseline & 16 Weeks|||seconds||Standard Deviation|Mean
19410|NCT01785524|Primary|Change in Exercise Capacity - Time to Exhaustion (TTE)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.|Baseline & 16 Weeks|||seconds||Standard Deviation|Mean
19411|NCT01785524|Secondary|Change in Angiogenesis|Gastrocnemius muscle biopsy will be performed to measure markers of angiogenesis including; capillaries per unit area and per muscle fiber, endothelial cells with surrounding pericytes, relative fraction of type I, IIa, IIb, and IId/x fibers. If differences exist we will look for changes in cell proliferation (PCNA) and apoptosis (TUNEL); (b) oxidative capacity including; mitochondria volume with citrate synthase activity. (c) mitochondrial volume and density; (d) mitochondrial oxygen efficiency (respiratory control ratio, the ratio of ATP phosphorylation rate per oxygen consumption rate (P/O ratio), and maximal rate of ATP production). These are measurements for potential mediation analyses and gaining insight into the relative effect sizes will inform mechanistic aims in a larger trial.|Baseline and 16 weeks||||||
19412|NCT01785524|Secondary|Change In Vascular Function|Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), calf blood flow (plethysmography), and arterial stiffness (pulse wave velocity and pulse wave reflection).|Baseline and 16 weeks||||||
19413|NCT01785524|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks|||feet||Standard Deviation|Mean
19414|NCT01785524|Primary|Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.|Baseline & 16 Weeks|||ml/kg/min||Standard Deviation|Mean
19415|NCT01785472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|baseline, 8 weeks|Safety Set (SAF): All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment they received.||Participants|||Number
19416|NCT01785472|Secondary|Number of Responders|Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline)|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments||Participants|||Number
19417|NCT01785472|Secondary|Change From Baseline in Ambulatory Pulse Pressure|Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
19418|NCT01785472|Secondary|Number of Patients Achieving Successful Blood Pressure Control|Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||Number of participants|||Number
19419|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
19420|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
19421|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
19422|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Deviation|Mean
19423|NCT01785472|Secondary|Change From Baseline in Mean 24-hour Ambulatory Blood Pressure|In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study.|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed||mmHg||Standard Error|Least Squares Mean
19424|NCT01785472|Secondary|Change From Baseline in Office Pulse Pressure (msPP)|Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Least Squares Mean
19425|NCT01785472|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Mean
19426|NCT01785472|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Least Squares Mean
19427|NCT01785472|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments||mmHg||Standard Error|Least Squares Mean
19428|NCT01785160|Primary|Cmax ,ss|"C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for ‘subject’ and ‘treatment’.~RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods||ng/mL||Geometric Coefficient of Variation|Geometric Mean
19456|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 31 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (31 days) minus earliest time point.|baseline and 31 days later|||units on a scale||Standard Deviation|Mean
19507|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Positive affect~Score range: 0 (minimum score) - 50 (maximum score)~High scores represent better outcomes"|baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
19429|NCT01785160|Primary|AUC( Tau,ss)|"AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for ‘subject’ and ‘treatment’.~RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
19430|NCT01785134|Secondary|Blood Lipids||2 years postoperative|||P-Cholesterol mmol/L||Standard Deviation|Mean
19431|NCT01785134|Secondary|Body Mass Index at 2 Years||2 years postoperative|||Kg/meter squared||Standard Deviation|Mean
19432|NCT01785134|Secondary|Blood Pressure at 2 Years||2 years postoperative|||mm Hg systolic||Standard Deviation|Mean
19433|NCT01785134|Secondary|Body Composition at Two Years||2 years postoperative|||% body fat||Standard Deviation|Mean
19434|NCT01785134|Primary|Insulin Sensitivity at 2 Years|Insulin sensitivity measured by hyperinsulinemic euglycemic clamp|2 years postoperative|||glucose/kg body weight/min||Standard Deviation|Mean
19435|NCT01785095|Secondary|Total Dose of FSH Units Used.||after 2 weeks of treatment|||IU||Standard Deviation|Mean
19436|NCT01785095|Secondary|Number of Oocytes Retrieved|the number of oocytes retrieved in the first cycle and in the second cycle are compared.|after 2 weeks of treatment|||oocytes||Standard Deviation|Mean
19437|NCT01785095|Primary|Number of Patients Producing Anti-FSH Antibodies.|The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.|4 months.|presence of Antibodies against FSH||participants|||Number
19438|NCT01784614|Secondary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.||nanograms•hour/milliliter (ng•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
19439|NCT01784614|Secondary|PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
19440|NCT01784614|Secondary|Total Sleep Time (TST)|TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.||min||90% Confidence Interval|Least Squares Mean
19441|NCT01784614|Secondary|Latency to Persistent Sleep (LPS)|LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.||min||90% Confidence Interval|Geometric Mean
19442|NCT01784614|Primary|Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo|WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.||minutes (min)||90% Confidence Interval|Geometric Mean
19443|NCT01783938|Secondary|Investigator-assessed Rate of Progression|The progression rate at a specific timepoint is defined as the number of participants who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of randomized participants. As specified by modified RECIST 1.1, the evaluation of PD at Week 13 and Week 25 used the baseline tumor assessment as reference. For purposes of the primary analysis of progression rates, if a treated participant were missing his/her tumor assessment at the specified study week, then the results of the previous tumor response evaluation were to be carried forward. Both clinical and radiological progressions were counted as a progression outcome. A participant who died without a reported prior progression was considered to have progressed on the date of his/her death. Deaths before or at Week 13 are counted as progression outcome. Confidence interval based on the Clopper and Pearson method.|Week 13; Week 25|All treated participants; All participants who received at least one dose of any study therapy.||percentage of participants||95% Confidence Interval|Number
19444|NCT01783938|Secondary|Investigator-assessed Duration of Response (DOR)|Duration of response (DOR) was performed to further characterize the response rate at Week 25. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR was assessed for participants with confirmed response at Week 25. Median computed using Kaplan-Meier product-limit method.|Week 25 up to date of disease progression or death, up to approximately 2 years|All treated participants with confirmed response at week 25; Participants were censored at their last assessment date if response was not changed.||months||95% Confidence Interval|Median
19763|NCT01778985|Secondary|Serum Estrone Levels, Surgery||Time of surgery|||pg/mL||Standard Error|Mean
19445|NCT01783938|Secondary|Investigator-assessed Response Rate at Week 25|Response rate is defined as the number of participants who have a complete response (CR) or partial response (PR) at Week 25 per modified RECIST 1.1 criteria, with confirmation on the scheduled scan at Week 33 (or any subsequent scan performed at least 4 weeks after the Week 25 scan), divided by the total number of treated participants. Results of the tumor assessment at Week 13 or any unscheduled tumor assessment obtained prior to Week 25, except for baseline/screening tumor assessment, were not considered in the assessment of response rate at Week 25. Any treated participant without an evaluable Week 25 time point response (per modified RECIST 1.1) was considered a non-responder for primary analysis of response rate at Week 25. Evaluations occurring after the dates of subsequent anticancer therapy were not included when determining or confirming response at Week 25. Confidence interval based on the Clopper and Pearson method.|Week 25|All treated participants; All participants who received at least one dose of any study therapy.||percentage of participants||95% Confidence Interval|Number
19446|NCT01783938|Primary|Percentage of Participants With Treatment-related Grade 3-5 Adverse Events (AEs) During the Induction Periods|The rate or percentage of participants with treatment-related grade 3-5 AEs is defined as the number of participants who experienced at least 1 treatment related Grade 3 - 5 adverse event (AE) per NCI CTCAE version 4.0 criteria, any preferred term with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. AEs with an onset date after start date of Continuation Period or start of subsequent anti-cancer therapy were not included. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to Week 25|All treated participants; All participants who received at least one dose of any study therapy.||percentage of participants||95% Confidence Interval|Number
19447|NCT01783912|Primary|Acceptance of Wisconsin Tobacco Quit Line Services|The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.|4-6 weeks after study enrollment|||participants|||Number
19448|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to week 52|FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
19449|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to week 52|FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
19450|NCT01783886|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline up to week 52|FAS with assessment for this outcome measure.||micrometer||Standard Deviation|Mean
19451|NCT01783886|Secondary|Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF|ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to week 52|FAS.||Percentage of participants|||Number
19452|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.||Percentage of participants|||Number
19453|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.||Percentage of participants|||Number
19454|NCT01783886|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.|Baseline up to week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA. FAS with assessment for this outcome measure.||Letters correctly read||Standard Deviation|Mean
19455|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 37 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (37 days) minus earliest time point.|baseline and 37 days later|||units on a scale||Standard Deviation|Mean
19508|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck youth inventories - Depression scale~Subscale range: 0 (minimum score) - 60 (maximum score)~Higher scores a worse outcome"|baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
19458|NCT01783860|Primary|Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.|zero time and 61 days later|||units on a scale||Standard Deviation|Mean
19459|NCT01783860|Secondary|Main Ocular Signs|lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment were measured. For each items there was a question with scale form zero to three (zero for no sign to three for maximum sign). Therefore, maximum score for signs was 21 (worse outcome) and minimum score was zero (better outcome). We calculated a total score for signs. Finally, we reported a change in total score calculated as the latest time point (61 days) minus earliest time point.|Change from baseline until 61 days after treatment|||units on a scale||Standard Deviation|Mean
19460|NCT01783860|Primary|Change of Blepharitis Symptoms Score|Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.|Change from the baseline until 61 days after treatment|||score||Standard Deviation|Mean
19461|NCT01783821|Secondary|Intensive Care Unit (ICU) Length of Stay||Baseline to Day 28|||days||Inter-Quartile Range|Median
19462|NCT01783821|Secondary|Hospital Length of Stay||Baseline to Day 28|||days||Inter-Quartile Range|Median
19463|NCT01783821|Secondary|Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)|ARDS was defined per Berlin definition. Chest radiographs of all ventilated (non-invasive or invasive) patients were reviewed as consistent or not consistent with ARDS by the site investigator. A second adjudication was performed by an alternate principal investigator blinded to subject identification and clinical data. Final diagnosis of ARDS was determined centrally after chest radiograph adjudication was considered together with other relevant clinical data.|Hospital discharge, approximately day 28|||participants|||Number
19464|NCT01783821|Secondary|Number of Subjects Who Needed Mechanical Ventilation||Hospital discharge, approximately day 28|||participants|||Number
19465|NCT01783821|Primary|Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|The data in the table below represent the greatest change from baseline observed for any one participant over all individual post-baseline measurements.|Days 0 - 5|Intention to Treat Analysis||participants|||Number
19466|NCT01783821|Primary|Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. The formula for the calculation of SpO2/FiO2 (or S/F ratio) is %saturation/proportion of FiO2 concentration.|baseline to day 5 after the first treatment|Intention to Treat analysis. The patient population for each day is indicated in the category by (treatment arm, placebo arm).||SpO2/FiO2 Ratio||Inter-Quartile Range|Median
19467|NCT01783730|Secondary|Percentage of Participants Achieving SDAI Remission|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. The percentage of participants with an SDAI score ≤3.3 was documented.|From baseline to 24 weeks|Participants with available data||percentage of participants|||Number
19468|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 24|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 24|Participants with available data||units on a scale||Standard Deviation|Mean
19469|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 12|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 12|Participants with available data||units on a scale||Standard Deviation|Mean
19509|NCT01783418|Secondary|Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention|"Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score)~Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
19470|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 4|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 4|Participants with available data||units on a scale||Standard Deviation|Mean
19471|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Baseline|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 0|Participants with available data||units on a scale||Standard Deviation|Mean
19472|NCT01783730|Secondary|Percentage of Participants Achieving CDAI Remission|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. The percentage of participants with a CDAI score ≤2.8 was documented.|From baseline to 24 weeks|Participants with available data||percentage of participants|||Number
19473|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 24|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 24|Participants with available data||units on a scale||Standard Deviation|Mean
19474|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 12|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 12|Participants with available data||units on a scale||Standard Deviation|Mean
19475|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 4|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 4|Participants with available data||units on a scale||Standard Deviation|Mean
19476|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Baseline|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 0|Participants with available data||units on a scale||Standard Deviation|Mean
19477|NCT01783730|Secondary|Percentage of Participants Achieving DAS28-4(ESR) Remission|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. The percentage of participants with a DAS28 score <2.6 was documented.|From baseline to 24 weeks|Participants with available data||percentage of participants|||Number
19478|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 24|Participants with available data||units on a scale||Standard Deviation|Mean
19479|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 12|Participants with available data||units on a scale||Standard Deviation|Mean
19480|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 4|Participants with available data||units on a scale||Standard Deviation|Mean
19481|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 0|Participants with available data||units on a scale||Standard Deviation|Mean
19482|NCT01783730|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.|From baseline through week 26|Participants who received adalimumab treatment||participants|||Number
19483|NCT01783678|Secondary|Percentage of Participants Experiencing Virologic Failure|"On-treatment virologic failure was defined as either:~Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline up to Posttreatment Week 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.||percentage of participants|||Number
19484|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
19485|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
19486|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
19487|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
19488|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.||log10 IU/mL||Standard Deviation|Mean
19489|NCT01783678|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.||percentage of participants|||Number
19490|NCT01783678|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
19491|NCT01783678|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. 1 participant with genotype 1 HCV infection did not have subtype information available.||percentage of participants|||Number
19492|NCT01783639|Secondary|Procedural Success|Defined as both device and angiographic success|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
19493|NCT01783639|Secondary|Angiographic Success|Successful completion of the protected stent procedure without angiographic complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
19494|NCT01783639|Secondary|Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks||Within 30 Days of procedure||||||
19495|NCT01783639|Secondary|The Rate of Access Site Complications||Within 30 Days of procedure||||||
19496|NCT01783639|Secondary|The Rate of Clinical Success|Defined as freedom from procedure related serious adverse events|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
19497|NCT01783639|Secondary|The Rate of Device Success|Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes||||||
19498|NCT01783639|Primary|The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.|Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.|Within 30 Days of procedure|||participants||95% Confidence Interval|Number
19510|NCT01783418|Primary|Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention|"Pittsburgh Sleep Quality Index~Score range: 0 (minimum score) - 21 (maximum score)~Higher scores indicate worse outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
19499|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.||units on a scale||Standard Error|Least Squares Mean
19500|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.||units on a scale||Standard Error|Least Squares Mean
19501|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS). Subpopulation of study participants aged 6-11 years.||units on a scale||Standard Error|Least Squares Mean
19502|NCT01783548|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment. Subpopulation of study participants aged 6-11 years.||units on a scale||Standard Error|Least Squares Mean
19503|NCT01783496|Secondary|Subject Satisfaction With Treatment Results|"subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 – Very Satisfied, 4 - Satisfied, 3 – Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 – Very Dissatisfied.~Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater (‘satisfied’ or ‘very satisfied’)."|6 months|||percentage of subjects satisfied|||Number
19504|NCT01783496|Secondary|Improvement in Skin Laxity (Subject Self-assessed)|Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.|6 months|||units on a scale||Standard Deviation|Mean
19505|NCT01783496|Primary|Improvement in Laxity|Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 – Very Significant Improvement (76-100%), 3 – Marked Improvement (51-75%), 2 – Moderate Improvement (26-50%), 1 – Minor/Mild Improvement (1-25%), or 0 – No Improvement.|6 months|||units on a scale||Standard Deviation|Mean
19506|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Negative affect~Score range: 0 (minimum score) - 50 (maximum score) Higher scores represent worse outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
22362|NCT01729026|Secondary|Beck Depression Inventory - II (BDI-II)|Self-rating scale that assesses the frequency and severity of common symptoms of depression|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
19511|NCT01783418|Primary|Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention|"Pediatric Cancer Quality of Life Inventory~Scale range: 0 (minimum score) to 108 (maximum score) Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
19512|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck Youth Inventory - Anxiety scale Subscale range: 0 (minimum score) - 60 (maximum score)~Higher scores indicate higher anxiety and a worse outcome"|Baseline, Post-intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
19513|NCT01783054|Secondary|Number of Adverse Events Reported in Subjects Enrolled.|Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0.|First study drug administration until end of study|All subjects who were administered study intervention and had documented adverse events were analyzed. The number below represents the number of adverse events, including serious adverse events, reported on by enrolled subjects. A complete list of the adverse events reported are in the adverse events tables of these results.||adverse events|||Number
19514|NCT01783054|Secondary|Estimate Median Overall Survival|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.||days|||Number
19515|NCT01783054|Secondary|Estimate Median Time to Recurrence.|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.||days|||Number
19516|NCT01783054|Other Pre-specified|Circulating Tumor Cells (CTC)|To evaluate and describe CTC number, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniquen from patients with pancreatic adenocarcinoma. To determine and evaluate the correlation between expression of biomarkers in CTCs and expression of biomarkers in resected tissue specimen with the same cancer patient.|From enrollment to surgery|This outcome measure was added as part of an amendment. No subjects were enrolled after this amendment was instituted, so no outcomes measures were collected.|||||
19517|NCT01783054|Secondary|Number of Participants With R0 Resection Status.|R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor.|at time of surgery|Subjects who had surgical resection are included in the analysis for this endpoint.||participants|||Number
19518|NCT01783054|Primary|Tumor Response|Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen. A good response is defined as a grade III or IV histopathologic appearance, equivalent to <10% viable tumor.|at time of surgery|The study terminated early and the data for this outcome measure was not documented.|||||
19519|NCT01783015|Secondary|Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19520|NCT01783015|Secondary|Number of Participants With Positive Etanercept Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19521|NCT01783015|Secondary|Change From Baseline in Vectra Disease Activity Levels|The change from Baseline in Vectra disease activity levels was to be estimated. The assessment measures serum protein biomarkers associated with RA. It has a range from 1-100 with lower scores indicating the better outcome.|Baseline, 12 weeks, 24 weeks|Vectra disease activity analysis of laboratory samples was not conducted due to study termination.|||||
19522|NCT01783015|Secondary|Change From Baseline in Patient Acceptable Symptom State (PASS)|The Patient Acceptable Symptom State (PASS) was a participant-completed form in which participants were asked to “Think about all the ways your rheumatoid arthritis (RA) has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable or unacceptable to you?” The participant indicated a response of either “acceptable” or “unacceptable”.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19523|NCT01783015|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The 36-Item Short Form Health Survey (SF-36) is widely used 36-item questionnaire that measures general health-related quality of life in the following 8 domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0 to 100 where higher scores are better.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19537|NCT01783015|Secondary|Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19524|NCT01783015|Secondary|Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)|The EuroQol-5 Dimensions (EQ-5D) is a participant-completed questionnaire designed to assess health related quality of life. There are 2 components to the EQ-5D: a Health State Profile and a VAS. For the Health State Profile, participants recorded their level of current health for 5 domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from the 5 domains may be used to calculate a single index value, also known as a utility score. On the VAS participants were asked to rate their current health on a scale from 0 to 100 mm, where 0 represented the “worst imaginable health state” and 100 represented the “best imaginable health state.” In addition to a summary of mean changes, 1 categorical endpoint each based on EQ-5D utility score and 1 based on the VAS were derived and analyzed: EQ-5D utility score improvement ≥0.05 and EQ-5D VAS score >82.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19525|NCT01783015|Secondary|Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19526|NCT01783015|Secondary|Change From Baseline in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19527|NCT01783015|Secondary|Change From Baseline in Subject Pain|Subject Pain was to be measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no pain and 100 mm = most severe pain.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19528|NCT01783015|Secondary|Change From Baseline in Subject General Health VAS.|Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19529|NCT01783015|Secondary|Change From Baseline in Subject Global Assessment of Disease Activity|Change from Baseline in Subject Global Assessment of Disease Activity was to be estimated. Participants were to assess their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19530|NCT01783015|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|Change from Baseline in the PGA scores was to be estimated. The Study Physician estimated the participant's overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19531|NCT01783015|Secondary|Change From Baseline in Number of Swollen Joints|Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19532|NCT01783015|Secondary|Change From Baseline in Number of Tender/Painful Joints|Change from Baseline in the number of tender/painful joints using the 28 joint count including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19533|NCT01783015|Secondary|Change From Baseline in SDAI.|Change from Baseline in SDAI scores were to be calculated. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19534|NCT01783015|Secondary|Change From Baseline in CDAI|Change from Baseline in CDAI scores was to be calculated. The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19535|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).|The SDAI is the numerical sum of five outcome parameters: TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19536|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19538|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and ≥ 90% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19539|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and ≥ 70% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19540|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and ≥ 50% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19541|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant's assessment of pain; Subject Global Assessment (SGA) of disease activity; Physician Global Assessment (PGA) of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19542|NCT01783015|Secondary|Number of Participants With DAS28 <2.6|Number of Participants with DAS28 <2.6. A DAS28 < 2.6 implies remission.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19543|NCT01783015|Secondary|Number of Participants With DAS28 <3.2|Number of participants with DAS28 <3.2. A score of < 3.2 implied low disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19544|NCT01783015|Secondary|Change From Baseline in the DAS28 at Week 24|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the CRP and and Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19545|NCT01783015|Primary|Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks|Due to small sample size, Pfizer did not perform statistical analysis.|||||
19546|NCT01782898|Secondary|Post Operative Pain Reported by the Subject.|Post operative pain reported by the subject as determined as area under the numeric rating scale for pain versus time curve in the post anesthesia care unit ( score*min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain over 24 hours.The range is 0 pain to x time in minutes x hour ( 60-1440 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU to 24 hours after the surgical procedure. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|24 hour|||(pain score * minutes ) in the PAC U||Inter-Quartile Range|Median
19547|NCT01782898|Secondary|Postoperative Opioid Consumption|The total amount of opioid consumed by subject at 24 hours after surgery measured in IV morphine equivalents.|24 hours|||IV mg of morpine equivalents||Inter-Quartile Range|Median
19548|NCT01782898|Primary|Qor-40 at 24 Hours Postoperative|"Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.~Time frame for this evaluation is 24 hours after the surgical procedure"|24 hours|||units on a scale 40 low-200 high||Inter-Quartile Range|Median
19549|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|24 weeks|||units on a scale||Standard Deviation|Mean
19550|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|12 weeks|||units on a scale||Standard Deviation|Mean
19551|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|6 weeks|||units on a scale||Standard Deviation|Mean
19552|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|24 weeks|||units on a scale||Standard Deviation|Mean
19735|NCT01780324|Primary|Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale|Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.|At time of procedure (up to 30 seconds after catheter insertion)|||units on a scale||95% Confidence Interval|Median
19553|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|12 weeks|||units on a scale||Standard Deviation|Mean
19554|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|6 weeks|||units on a scale||Standard Deviation|Mean
19555|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|0 weeks|||units on a scale||Standard Deviation|Mean
19556|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|0 weeks|||units on a scale||Standard Deviation|Mean
19557|NCT01782885|Secondary|Change in Visual Analog Scale (VAS)|The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?|0-24 weeks|||Centimeters||Standard Deviation|Mean
19558|NCT01782872|Secondary|Middle Deltoid|A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer|24 hours after surgery|Patients who agreed to the measurements were included in the analysis.||kgf||Inter-Quartile Range|Median
19559|NCT01782872|Secondary|Numeric Rating Scale (NRS) Pain Scores at Rest|Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest|Preop|||units on a scale||Inter-Quartile Range|Median
19560|NCT01782872|Secondary|Duration of Analgesia From Interscalene Nerve Block|Median time until a patient needed to take opioid pain medication|Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM|Patients who were able to provide actual or estimates of time until they first needed to use pain medication were included in this analysis.||hours||Standard Error|Mean
19561|NCT01782872|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the interscalene block is given|||units on a scale||Standard Deviation|Mean
19562|NCT01782859|Secondary|Pain at 3 Months Post-op|At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.|3 months postoperatively|||units on a scale||Standard Deviation|Mean
19563|NCT01782859|Secondary|Desmosine Level (Marker of Lung Injury)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days|Desmosine levels were not analyzed.|||||
19564|NCT01782859|Secondary|Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days|||picograms/milliliter||Standard Deviation|Mean
19565|NCT01782859|Primary|Plasmin-a 2 Antiplasmin Complex (PAP)||First 24 hours after surgery|||mcg/L||Standard Deviation|Mean
19566|NCT01782859|Primary|Serum Prothrombin Fragment 1 and 2 (PF 1.2)||First 24 hours after surgery|||pmol/mL||Standard Deviation|Mean
19567|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in Non ApoE4 Carriers|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in non ApoE4 Carriers|Baseline to Week 4|Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.||ratio||95% Confidence Interval|Mean
19568|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in All Subjects|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in all subjects|Baseline to Week 4|There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.||ratio||95% Confidence Interval|Mean
19569|NCT01782742|Secondary|Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (Non ApoE4 Carriers)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes (non ApoE4 carriers)|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels in non ApoE4 carriers. Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.||pmol/L||95% Confidence Interval|Mean
19736|NCT01779648|Secondary|Cycling Rate|Number of cuff inflation-deflation cycle during an hour. In group SF, the cycling rate is fixed as 90 cycles/hour, but in group AA, it is variable according to the individual venous refill time.|on 4th postoperative day after total knee replacement arthroplasty|||cycles/hour|Participants|Standard Deviation|Mean
19570|NCT01782742|Secondary|Secondary Outcome Measuring Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (ALL SUBJECTS)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes in ALL SUBJECTS. There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.||pmol/L||95% Confidence Interval|Mean
19571|NCT01782742|Primary|Primary Outcome by Genotype (HOMOZYGOTE ApoE4 CARRIERS)|"This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HOMOZYGOTE ApoE4 CARRIERS)~There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."|Baseline to Week 4|"Change in composite and regional Beta Amyloid burden on Homozygote ApoE4 carriers.~There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."||SUVr||95% Confidence Interval|Mean
19572|NCT01782742|Primary|Primary Outcome by Genotype (HETEROZYGOTE ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HETEROZYGOTE ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on Heterozygote ApoE4 carriers||SUVr||95% Confidence Interval|Mean
19573|NCT01782742|Primary|Primary Outcome by Genotype (ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on ApoE4 carriers||SUVr||95% Confidence Interval|Mean
19574|NCT01782742|Primary|Primary Outcome by Genotype (NON ApoE4 CARRIERS)|Measures changes from baseline on treatment compared to placebo at week 4 on composite and regional Beta Amyloid burden according to ApoE genotype (NON ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid Burden on non-ApoE4 carriers||SUVr||95% Confidence Interval|Mean
19575|NCT01782742|Primary|Primary Outcome by Genotype (ALL SUBJECTS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers compared to E-4 non-carriers)|Baseline to Week 4|Change om composite and regional Beta Amyloid burden according to ApoE genotype on ALL SUBJECTS||SUVr||95% Confidence Interval|Mean
19576|NCT01782742|Secondary|Change in the Activities of Daily Living (ADCS-ADL) Score in ALL Subjects From Baseline to Week 4|The ADCS-ADL is an activities-of-daily-living inventory developed by the ADCS to assess functional performance in participants with AD (Galasko et al., 1997). Using a structured interview format, study partners are queried as to whether participants attempted each item in the inventory during the prior 4 weeks and their level of performance. Overall score range from 0 meaning fully independent to 78 meaning fully dependent on assistance for activities of daily living|Baseline to Week 4|||points||95% Confidence Interval|Mean
19577|NCT01782742|Secondary|Change in NPI Scores in ALL Subjects From Baseline to Week 4|The NPI is a well validated, reliable, multi-item instrument to assess psychopathology in AD based on interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric disturbances. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously) as well as severity (1=mild, 2=moderate, 3=severe). The overall score and the score for each subscale are the product of severity and frequency. Overall score range from 0 meaning no disturbance to 144 meaning severe disturbance|Baseline to Week 4|||points||95% Confidence Interval|Mean
19578|NCT01782742|Secondary|Change in the Global Clinical Dementia Rating Score in ALL Subjects From Baseline to Week 4|The CDR is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe (CDR score of 0, 0.5, 1, 2, or 3, respectively). Higher score means more severe dementia rating. The score is based on interviews with the participant and study partner, using a structured interview that assesses six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.|Baseline to Week 4|||units on a scale||95% Confidence Interval|Mean
19579|NCT01782742|Secondary|Change in ADAS-Cog Score in ALL Subjects From Baseline to Week 4|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 85 (worse). A positive change indicates cognitive worsening.|Baseline to Week 4|||points||95% Confidence Interval|Mean
19580|NCT01782742|Secondary|Change in MMSE Score in ALL Subjects From Baseline to Week 4|The MMSE evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons. A lower score indicates more cognitive impairment. The lowest score that any particular person can get is 0 and the highest score is 30.|Baseline to Week 4|||points||95% Confidence Interval|Mean
19581|NCT01782742|Primary|Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain|The primary study endpoint for all subjects is the change from baseline to Week 4 in amyloid burden as measured by standard uptake units regional (SUVr) on amyloid brain imaging obtained through 18F-AV-45 PET|Baseline to Week 4|||SUVr||95% Confidence Interval|Mean
19582|NCT01782482|Secondary|Positive Purchase Intent|"As reported on a questionnaire in response to, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing Definitely would purchase or Probably would purchase."|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||Percentage of participants|||Number
19652|NCT01781481|Primary|IBD Disease Severity|IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|||percentage of participants|||Number
19583|NCT01782482|Primary|Subjective Rating of Overall Satisfaction|Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||Units on a scale||Standard Error|Mean
19584|NCT01782469|Secondary|Mean Change in Health Assessment Questionnaire (HAQ) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.|Baseline (Visit 1) to 13 weeks|Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.||units on a scale||Standard Deviation|Mean
19585|NCT01782469|Secondary|Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)|The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).|Baseline (Visit 1) to 13 weeks|All enrolled participants||percentage of participants||95% Confidence Interval|Number
19586|NCT01782469|Secondary|Mean Number of Joints With Detected Erosions|A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.|Baseline (Visit 1) to 13 weeks|Participants with available data||joints||Standard Deviation|Mean
19587|NCT01782469|Secondary|Mean Percent Reduction in Ultrasonography Assessment Score|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data||Percent reduction||Standard Deviation|Mean
19588|NCT01782469|Primary|Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data||units on a scale||Standard Deviation|Mean
19589|NCT01782326|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|52 weeks of treatment + 30 days|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included||Number of participants|||Number
19590|NCT01782326|Secondary|Change From Baseline in Forced Vital Capacity|Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction|4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included||Liters||Standard Error|Least Squares Mean
19591|NCT01782326|Secondary|Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.|Urine cortisol/creatinine ratio|Baseline, 52 Weeks|Urine cortisol set is the subset of patients who were measured with 24-hour Urine cortisol, a subset of safety set. The safety set included all patients who received at least one dose of study drug. At the post-baseline timepoint only patients with a value at both baseline and the post-baseline timepoint are included.||ng/mL||Full Range|Median
19592|NCT01782326|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication|A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in LLM are included.||Number of puffs per day||Standard Error|Least Squares Mean
19600|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
19593|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
19594|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
19595|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
19596|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
19597|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in MMRM are included.||Score on a scale||Standard Error|Least Squares Mean
19598|NCT01782326|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time”|Baseline, 52 weeks|Serial spirometry set - Serial spirometry set includes the patients who performed additional serial spirometry, a subset of FAS. Only patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
19599|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
19633|NCT01781481|Primary|Total Number of Hospital Services Involved in Child's Care.|Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||R Square change statistic||Full Range|Median
19653|NCT01781481|Primary|Pediatric INTERMED Items|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.|Day 1 (At time of Pediatric Intermed Interview)|||Percentage of participants|||Number
19601|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
19602|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
19603|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
19604|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, day 1 (30 min and one hour post dose)|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and did not have any major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.||Liters||Standard Error|Least Squares Mean
19605|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
19606|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
19607|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
19608|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
19634|NCT01781481|Primary|Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.|Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis|||Correlation Coefficients|||Number
19654|NCT01781481|Primary|Correlations Between Pediatric INTERMED Domain Scores|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.|Pediatric INTERMED scores at time of study participation|||Correlation Coefficient|||Number
19609|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||Standard Deviation|Mean
19610|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.|All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
19611|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included .|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
19612|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
19613|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks.|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in the Cox regression model are included.||Days||95% Confidence Interval|Median
19614|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations.|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
19615|NCT01782326|Secondary|Time to First COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.||Days||95% Confidence Interval|Median
19616|NCT01782326|Primary|Rate of COPD Exacerbations|COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used.|52 weeks|The per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Only PPS patients with non-missing values for all terms in negative binomial model are included.||COPD Exacerbations/year||95% Confidence Interval|Least Squares Mean
19737|NCT01779648|Secondary|Augmented TVF|Enhanced total volume flow by application of pneumatic compression|on 4th postoperative day after total knee replacement arthroplasty|||mL/min|Participants|Standard Deviation|Mean
19617|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness)|"The Clinical Global Impression (CGI) scales (Guy and Bonato, 1970) were initially developed for a risk-benefit estimation within the treatment of mentally ill patients. The 4 global scales (severity of illness, change in severity from Baseline, therapeutic efficacy, and tolerability of treatment) are used as different measures of treatment outcome in different kinds of pharmacological studies.~The CGI Item 1 (severity of illness) collected 1 answer out of 8 categories (0-‘Not assessed’, 1-‘Normal, not at all ill’, 2-‘Borderline ill’, 3-‘Mildly ill’, 4-‘Moderately ill’, 5-‘Markedly ill’, 6-‘Severely ill’, and 7-‘Among the most extremely ill patients’) at each assessment. The category 0-‘Not assessed’ was considered as missing and therefore used neither for calculation nor for display purposes."|Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||participants|||Number
19618|NCT01782222|Secondary|"Change From Baseline to the End of the Maintenance Period in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) in on State"|"Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit.~The UPDRS Part III (motor subscale) had to be measured in the “on” state and consisted of 27 items and sub items scored between 0 and 4. The sum score ranged between 0 and 108 and was calculated as sum of the 27 individual scores. If 1 or more items were missing and could not be substituted with a previous post-Baseline value, the sum score was also missing.~A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19619|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory (BDI) is a self-report instrument to measure depression symptoms and severity (Beck et al, 1961). The BDI-II is a revised version of the scale in order to be more consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression (Beck et al, 1996). There are 21 items in the BDI-II, classified as cognitive-affective (Items 1-13) and somatic-performance (Items 14-21) subscales. The degree of severity is indicated on a 4-point scale; items are rated from 0 (not at all) to 3 (extreme form of each symptom). Scores of 0-13 indicate minimal depression, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19620|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)|The Snaith Hamilton Pleasure Scale (SHAPS) (Snaith et al, 1995) is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores range from 0 to 14. A higher score represents more anhedonic symptoms.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19621|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Mood / Cognition Domain of the Nonmotor Symptom Assessment Scale (NMSS)|"Nonmotor performance was assessed via the Nonmotor Symptom Assessment Scale (NMSS), an accepted scale that has been validated in an international study (Naidu et al, 2006; Chaudhuri et al, 2007), at the Baseline Visit as well as at the end of the Maintenance Period. The severity and frequency of the subject’s nonmotor symptoms were assessed by the investigator (or designee) in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; and miscellaneous.~Items are scored for severity (from 0 (none) to 3 (severe)) and frequency (from 1 (rarely) to 4 (very frequent )). The score was calculated as severity x frequency. The theoretical minimum is 0 (best possible outcome) and maximum total score is 360 points (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19622|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 collects 8 items with 5 categories each (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always or cannot do at all). The total score was calculated by summing the scores of all applicable questions and convert the resulting sum to a summary index score between 0 and 100 by multiplying with 100/32. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19623|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Caregiver (Where Available)|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the caregiver. The questions were asked in a structured interview format. The caregiver was interviewed by appropriate medical staff and asked questions about the subject in the third person.The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19624|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Total Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living) + III (Motor Symptoms)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject’s activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19625|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the subject. The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.||scores on a scale||Standard Deviation|Mean
19626|NCT01781962|Secondary|Number of Study Eyes in Each Step Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.||eye|Participants||Number
19627|NCT01781962|Secondary|Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.||eye|Participants||Number
19628|NCT01781962|Primary|Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)|The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.|Day 1|Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure.||µm|Participants|Standard Deviation|Mean
19629|NCT01781481|Primary|Number of Inpatient Hospital Admissions|Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Number of hospital admissions||Full Range|Median
19630|NCT01781481|Primary|Number of Visits to the Hospital Emergency Department|Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Emergency Department Visits||Full Range|Median
19631|NCT01781481|Primary|Number of Extra Appointments With the IBD Team|Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Number of appointments||Full Range|Median
19632|NCT01781481|Primary|Number of Calls to IBD Nurse|Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)|||Number of calls||Full Range|Median
19738|NCT01779648|Secondary|Augmented PVF|Enhanced peak volume flow by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty|||mL/min|Participants|Standard Deviation|Mean
19635|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.||participants|||Number
19636|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.||participants|||Number
19637|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.||participants|||Number
19638|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.||participants|||Number
19639|NCT01781481|Primary|Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.|Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).|Day 1 (Time of Study Participation)|||Pearson Correlation Coefficient|||Number
19640|NCT01781481|Primary|Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.|Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis|||Correlation Coefficients|||Number
19641|NCT01781481|Primary|Family Inventory of Resources for Management|Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.||units on a scale||Inter-Quartile Range|Median
19642|NCT01781481|Primary|Family Inventory of Life Events and Changes|Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.||units on a scale||Inter-Quartile Range|Median
19643|NCT01781481|Primary|Pediatric Inventory for Parents- Difficulty Score|"Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater perceived difficulty."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.||units on a scale||Inter-Quartile Range|Median
19644|NCT01781481|Primary|Multidimensional Anxiety Scale for Children|"Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) never true about me to (3) often true about me. Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.||units on a scale- T scores||Inter-Quartile Range|Median
19645|NCT01781481|Primary|Children's Depression Inventory|27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.|Administered at study entry|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.||Units on a Scale - T Scores||Inter-Quartile Range|Median
19646|NCT01781481|Primary|Child Behaviour Checklist|Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.||Units on a Scale - T Scores||Inter-Quartile Range|Median
19647|NCT01781481|Primary|Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.|35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.||units on a scale||Inter-Quartile Range|Median
19648|NCT01781481|Primary|Functional Disability Inventory|"Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) no trouble to (4) impossible. The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991)."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|||units on a scale||Full Range|Median
19649|NCT01781481|Primary|IBD Treatment With Immunomodulators or Anti-TNFa Medications|"Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as yes (Score of 1) or no (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as yes (Score of 1) or no (Score of 2)."|Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).|||Percentage of participants treated|||Number
19650|NCT01781481|Primary|Disease Course and Treatment|Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).|Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)|||number of times it occurred||Full Range|Median
19651|NCT01781481|Primary|Time Since IBD Diagnosis|"Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in months since date of diagnosis, with a range from 1 - 131 months."|Data collected through chart review at time of Pediatric INTERMED interview.|||Percentage of Participants|||Number
19655|NCT01781481|Primary|Pediatric INTERMED- Complexity Index|"34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action).~Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains:~Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity).~Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity).~Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity).~Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity).~Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity)."|Time of Study Participation (Completion of Pediatric INTERMED tool)|||scores on a scale||Inter-Quartile Range|Median
19656|NCT01781403|Other Pre-specified|Disease-free Survival||3-year or 5-year after surgery||||||
19657|NCT01781403|Other Pre-specified|Efficacy|"Efficacy: Pathologic major responses = total regression + near total regression.~We will carefully inspect the circumferential resection margin, defining a positive margin as any residual tumor within ≤ 1 mm of the circumferential margin.~Pathologic responses and stages will be classified according to Dworak’s classification1 and the AJCC (American Joint Committee on Cancer) staging system, respectively. In each case, the entire tumor including mesorectal fat will be serially sliced into 4-mm-thick sections and embedded in paraffin.~A pathologic complete response is defined as grade 4 tumor regression; with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells~A near total response is defined as grade 3 tumor regression; with very few tumor cells in fibrotic tissue with or without mucous substance."|after surgery (6-8 weeks after study treatment)||||||
19658|NCT01781403|Other Pre-specified|Toxicity|"Toxicity will be monitored and recorded every week during study treatment (5 or 6 weeks) as following according to the NCI-CTCAE version 4.0~An interval history and physical examination with particular attention to drug-induced side effects along with documentation of the patient’s weight and performance status will be performed on each visit.~CBC with differential count, blood chemistry including calcium, phosphorus, glucose, BUN, creatinine, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, and electrolyte will be performed before next planned treatment.~All relevant information regarding drug dosage, laboratory examinations, and treatment-related toxicities must be recorded before each treatment is given.~Summaries of the frequency and severity of adverse effects are based on the worst episodes recorded."|5-6 weeks during study treatment|||events|||Number
19659|NCT01781403|Secondary|Pathological Complete Response|"Pathologic responses and stages were classified according to Dworak’s classification and the 7th edition of the American Joint Committee on Cancer staging system, respectively.~The pathologic complete response (pCR) was defined as the total regression of the primary tumor regardless of regional lymph nodal status (ypT0), with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells."|at the time of surgery (6-8 weeks after study treatment)|||participants|||Number
19660|NCT01781403|Primary|Recommended Dose (RD)|RD will be defined as one level below the MTD.|5-6 weeks after CRT|||mg/m^2|||Number
19661|NCT01781403|Primary|Maximum Tolerated Dose (MTD)|The MTD is defined as the maximum dose level in the doses of temozolomide tested with capecitabine and radiation in which the incidence proportion of DLT exceeds 30%.|5-6 weeks during study treatment|||mg/m^2|||Number
19662|NCT01781208|Primary|ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score|"Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures.~Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis."|10 minutes|"49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams.~48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams."||m/s||Standard Deviation|Mean
19663|NCT01781169|Primary|Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)||Endpoint and baseline of the 8 weeks' trial|||nmol/L||Standard Deviation|Mean
19664|NCT01781026|Primary|Activity of Vemurafenib in Untreated Brain Metastases|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|Subjects withdrew prior primary outcome measurement therefore no data was obtained to report|||||
19665|NCT01780987|Secondary|Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods|All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.||participants|||Number
19666|NCT01780987|Secondary|Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.||participants|||Number
19667|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)|Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated.||participants|||Number
19668|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)|Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated.||participants|||Number
19669|NCT01780987|Secondary|Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period|"VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. Intended Treatment Period was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late."|Baseline to Week 24|Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis.||participants|||Number
19670|NCT01780987|Primary|Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.||participants|||Number
19671|NCT01780935|Secondary|Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Screening to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19672|NCT01780935|Secondary|Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19673|NCT01780935|Secondary|Treatment Patterns Over Time in Both Treatment Arms at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19674|NCT01780935|Secondary|Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19675|NCT01780935|Secondary|Dry Retina in the Study Eye on OCT at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19676|NCT01780935|Secondary|Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19677|NCT01780935|Secondary|Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19739|NCT01779648|Secondary|Augmented MV|Enhanced mean velocity by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec|Participants|Standard Deviation|Mean
41623|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban After Three Days of 5 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
19678|NCT01780935|Secondary|Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 3 to Month 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19679|NCT01780935|Secondary|Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19680|NCT01780935|Secondary|Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19681|NCT01780935|Secondary|Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed|||||
19682|NCT01780935|Secondary|Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12|Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distanceof 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients||letters correctly read||Standard Deviation|Mean
19683|NCT01780935|Primary|Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12|Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients||Letters correctly read||Standard Deviation|Mean
19684|NCT01780922|Primary|Urinary Anti-bacteria Adhesion Activity||0, 3, 6, 9, 12, 24 h|||mg PAC/mg creatinine||Standard Error|Mean
19685|NCT01780922|Primary|Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19686|NCT01780922|Primary|Interferon-gamma (IFN-y) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19687|NCT01780922|Primary|Interleukin-10 (IL-10) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19688|NCT01780922|Primary|Interleukin-8 (IL-8) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19689|NCT01780922|Primary|Interleukin-6 (IL-6) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19690|NCT01780922|Primary|Interleukin-4 (IL-4) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19691|NCT01780922|Primary|Interleukin-2 (IL-2) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19692|NCT01780922|Primary|Interleukin-1beta (IL-1b) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19693|NCT01780922|Primary|Interleukin-1alpha (IL-1a) Concentrations in Plasma||0, 2, 4, 8, 24 h|||pg/mL||Standard Error|Mean
19694|NCT01780922|Primary|Nitric Oxide (NO) Concentrations in Plamsa||0, 2, 4, 8, 24 h|||umol/L||Standard Error|Mean
19695|NCT01780922|Primary|C-Reactive Protein (CRP) Concentrations in Plamsa||0, 2, 4, 8, 24 h|||ug/mL||Standard Error|Mean
19696|NCT01780922|Primary|Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2’-Deoxyguanosine (8-OHdG)||0, 2, 4, 8, 24 h|||ng/mL||Standard Error|Mean
19697|NCT01780922|Primary|Glutathione Peroxidase (GPx) Activity in Red Blood Cells||0, 2, 4, 8, 24 h|||mU/mg HgB||Standard Error|Mean
19698|NCT01780922|Primary|Superoxide Dismutase (SOD) Activity in Red Blood Cells||0, 2, 4, 8, 24 h|||mU/mg HgB||Standard Error|Mean
19699|NCT01780922|Primary|Reduced Glutathione (GSH) Concentrations in Red Blood Cells||0, 2, 4, 8, 24 h|||mmol/L||Standard Error|Mean
19700|NCT01780584|Other Pre-specified|Postoperative Hospital Length of Stay||up to 3 month after surgery|||days||Full Range|Median
19701|NCT01780584|Other Pre-specified|Postoperative Length of Stay in Intensive Care Unit||up to 3 months after surgery|||hours||Full Range|Median
19702|NCT01780584|Other Pre-specified|Postoperative Time to Extubation|Postoperative time to extubation is length of time on ventilator.|up to 3 months after surgery|||hours||Full Range|Median
19721|NCT01780506|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
19703|NCT01780584|Secondary|Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms.|Specific symptoms of hyperthyroidism included cardiac dysrhythmia requiring medical or electrical treatment, hypertension (mean systolic or diastolic blood pressure more than 2 standard deviation above normal for age) and hyperthermia (>37.5 degree Celsius). One patient in low dose group had hypertension directly after surgery due to unrecognized coarctation of the aorta and this patient was withdrawal from the protocol.|Since the first dose of oral T3 until 7 days after surgery|Three patients were excluded from adverse effect analysis. Two patients, each in placebo and high dose group were on Extracorporeal Membrane Oxygenation. One patient in high dose group could not attained enteral feeds due to gastrointestinal bleeding and was withdrawal from the protocol.||participants|||Number
19704|NCT01780584|Primary|Free T3 (FT3) Levels|Free T3 levels were measured up to 36 hours after cross-clamp removal|during the first 36 hours after cross clamp removal|Two subjects (one in T3 low dose and one in T3 high dose) were withdrawn from the treatment protocol. The withdrawal in low dose group was because of severe hypertension caused by a previously unrecognized coarctation of the aorta, and the high dose group withdrawal was due to massive gastrointestinal bleeding.||pg/ml||Standard Error|Mean
19705|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
19706|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
19707|NCT01780506|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
19708|NCT01780506|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percent change in ratio (µg/g)||Inter-Quartile Range|Median
19709|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 96 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
19710|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.||percentage of participants|||Number
19711|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
19712|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||mg/dL||Standard Deviation|Mean
19713|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
19714|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
19715|NCT01780506|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
19716|NCT01780506|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
19717|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with on-treatment data were analyzed.||cells/µL||Standard Deviation|Mean
19718|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.||cells/µL||Standard Deviation|Mean
19719|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48 and 96|Full Analysis Set||percentage of participants|||Number
19720|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Full Analysis Set||percentage of participants|||Number
19722|NCT01780389|Secondary|Change in Total Score of Short Form-36 (SF-36), Measuring Perceived Quality of Life|"Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.~The eight sections are:~vitality,~physical functioning,~bodily pain,~general health perceptions,~physical role functioning,~emotional role functioning,~social role functioning,~mental health~Scale:~0= lowest quality of life 100= high quality of life Higher scores reflect higher quality of life. Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
19723|NCT01780389|Secondary|Change in Total Score of State Trait Anxiety Inventory (STAI)|"Assessment of subjective symptoms of current anxiety and chronic anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” All items are rated on a 4-point scale (e.g., from “Almost Never” to “Almost Always”). Higher scores indicate greater anxiety.~Lowest total score is 40 (absent anxiety) Highest total score is 160 (maximum anxiety) Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
19724|NCT01780389|Secondary|Change in the Montgomery Asberg Depression Rating Scale|"Staff-rated assessment of depressive symptoms. Scale is as follows:~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Between baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
19725|NCT01780389|Secondary|Change in the Beck Depression Inventory (BDI-II)|"The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression. The higher the score the degree of depression."|Baseline to endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
19726|NCT01780389|Secondary|Change in Total Score of Multidimensional Fatigue Inventory (MFI-20)|"Measures subjective fatigue.20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue.~Each scale contains four items rated on a scale of one to 5 with the scale score of one having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. The five scales were identified through factor analysis and are assumed to measure different aspects of fatigue. Lowest possible total score = 20 (absent fatigue) Highest possible total score = 100 (maximum fatigue) Total mean cumulative scores were reported"|Baseline to endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
19727|NCT01780389|Secondary|Global Rating of Change||Endpoint (12 weeks or early termination)|Data not collected.|||||
19728|NCT01780389|Secondary|Change in Knee Society Score (KSS).|"KSS measures subjective pain and objective function by joint physical exam. This secondary outcome was the change in Knee Society Score(KSS)from baseline through 12 weeks.~KSS scores measured on a scale of 0 to 100 mm:~0 = absence of pain or no pain noted 100= worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|between baseline and endpoint (12 weeks or early termination)|||units on a scale||Standard Deviation|Mean
19729|NCT01780389|Primary|Change in Pain Visual Analogue Scale(VAS).|"The primary outcome is change in pain VAS from baseline to 12 weeks (baseline score minus 12 week or endpoint score; positive number reflects reduction in pain score). The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm:~0= absence of pain or no pain noted 100 = worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|baseline and endpoint 12 weeks|||units on a scale||Standard Deviation|Mean
19730|NCT01780350|Secondary|Tolerability|Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.|Duration of device use, up to 1 hour|||participants|||Number
19731|NCT01780350|Primary|Change in Systolic Blood Pressure From Baseline (Before ITD Use)|Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.|During device use, up to 1 hour|||mmHg||Standard Deviation|Mean
19732|NCT01780337|Primary|Change in Electrophysiology Measure of Right Ventricular Refractory Period|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group.||milliseconds||Standard Deviation|Mean
19733|NCT01780337|Primary|Change in Electrophysiology Measure of HV Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group. Only 5 out of 6 were evaluable for the Saline group.||milliseconds||Standard Deviation|Mean
19734|NCT01780337|Primary|Change in Electrophysiology Measure of AH Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 3 out of 6 were evaluable for the Oxytocin group. Only 2 out of 6 were evaluable for the Saline group.||milliseconds||Standard Deviation|Mean
19740|NCT01779648|Secondary|Augmented PV|Enhanced peak velocity by application of intermittent pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec|Participants|Standard Deviation|Mean
19741|NCT01779648|Secondary|Expelled Peak Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled peak volume (EPV) = single cycle augmented PVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty|||mL/hour|Participants|Standard Deviation|Mean
19742|NCT01779648|Secondary|Expelled Total Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled total volume (ETV) = single cycle augmented TVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty|||mL/hour|Participants|Standard Deviation|Mean
19743|NCT01779648|Secondary|Total Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Total volume flow (TVF) was automatically calculated by the software.|On 4th postoperative days after total knee replacement arthroplasty|||mL/min||Standard Deviation|Mean
19744|NCT01779648|Secondary|Peak Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Peak volume flow (PVF) was automatically calculated with 1-second interval around the PV.|On 4th postoperative days after total knee replacement arthroplasty|||mL/min||Standard Deviation|Mean
19745|NCT01779648|Secondary|Mean Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Alternate compression arm) or 12 seconds (Simultaneous compression arm) were recorded. This is an automatically measured mean value of venous flow.|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec||Standard Deviation|Mean
19746|NCT01779648|Secondary|Peak Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Under fixed state of other ultrasound scan parameters, peak velocity (PV) was measured by determination of maximum point of the augmented waveform.|On 4th postoperative days after total knee replacement arthroplasty|||cm/sec||Standard Deviation|Mean
19747|NCT01779648|Primary|Rate of Deep Vein Thrombosis|Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.|On 4th postoperative days after total knee replacement arthroplasty|One participant of Group SF dropped out of the analysis due to the device error; air leakage in the closed circuit system.||participants|||Number
19748|NCT01779219|Secondary|Time|the preparation (Tprep), operation (Top) and total operating room (TOR) time|From moment of the transfer to the OR until the moment of transfer out of it, assessed on the day of operation.|||minutes||Standard Deviation|Mean
19749|NCT01779219|Secondary|Length of Hospital Stay|The preoperative (LOSpre), postoperative (LOSpost) and total length of hospital stay (LOS)|From date of hospitalization until the date of discharge, assessed up to 2 days.|||days||Full Range|Median
19750|NCT01779219|Primary|Diagnostic Yield|The diagnostic yield is expressed as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the operation.|For each patient 2 weeks after the operation|||participants|||Number
19751|NCT01779219|Primary|Number of Participants Presenting With Complications|The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the operation, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological or clinical signs of the intracranial expansion.|Patients were followed for the duration of hospital stay (average 2 days) and again 2 weeks after the operation.|Complications assessed: Haematoma, Neurological deterioration, Infection||participants|||Number
19752|NCT01778985|Secondary|Estimated Blood Loss|Intraoperative estimated blood loss|Time of surgery, i.e. after 6-8 weeks of intervention|In both study arms, 13 participants did undergo surgery and, therefore, had an estimated blood loss value available for analysis. However, one patient each from both study arms did not have biopsies taken (technical considerations/ intraoperative decision or conversion from total to supracervical hysterectomy without ability to collect biopsy).||mL||Standard Deviation|Mean
19753|NCT01778985|Primary|Vaginal Wall Degradative Activity, Mucosa, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.||Relative Units/mg protein||Standard Error|Mean
19754|NCT01778985|Primary|TGFB1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
19755|NCT01778985|Primary|Tropoelastin (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
19756|NCT01778985|Primary|LOXL1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
19757|NCT01778985|Primary|Lysyl Oxidase (LOX) (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Standard Error|Mean
19758|NCT01778985|Primary|hCOL3, (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|||ratio||Inter-Quartile Range|Median
19759|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Per-Protocol)|Will assess vaginal wall histology - thickness of lamina propria|Time of surgery, i.e. 6-8 weeks of intervention|||microns||Standard Error|Mean
19764|NCT01778985|Primary|Vaginal Wall Degradative Activity, Muscularis, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.||Relative Units/mg protein||Standard Error|Mean
19765|NCT01778985|Primary|Total Collagen Content in Vaginal Muscularis, (Per-Protocol)|Will assess hydroxy-proline assays as index of amount of collagen|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||mg collagen per mg muscularis wet weight||Standard Error|Mean
19766|NCT01778985|Secondary|Serum Estrone Levels, Baseline||Baseline|||pg/mL||Standard Error|Mean
19767|NCT01778985|Primary|hCOL1A1, Per-Protocol|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||ratio||Inter-Quartile Range|Median
19768|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Per-Protocol)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||microns||Standard Error|Mean
19769|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Intention to Treat)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"||microns||Standard Error|Mean
19770|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Per-Protocol)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"||microns||Standard Error|Mean
19771|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Intention to Treat)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"||microns||Standard Error|Mean
19772|NCT01778751|Secondary|Depressive Symptoms|Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months|Baseline, 3m, 6m|||units on a scale||Standard Deviation|Mean
19773|NCT01778751|Secondary|Self-reported Medication Adherence|Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m|||participants|||Number
19774|NCT01778751|Secondary|Diabetes Self Care|Self-Care Inventory-revised as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m|||units on a scale||Standard Deviation|Mean
19775|NCT01778751|Primary|Diabetes Control|Hemoglobin A1c as measured at baseline, 3m, 6m|Baseline, 3months, 6months|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
19776|NCT01778530|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For details, see the adverse event module.|5 months, 28 days|||participants|||Number
19777|NCT01778530|Primary|Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105.|Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is >/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a >/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,|14 months|This outcome measure was not met due to termination of the study for poor accrual.|||||
19778|NCT01778296|Secondary|Cold Intolerance|We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).|18 months to 24 months||||||
19779|NCT01778296|Primary|Discriminatory Sensation of the Flap|Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.|18 months to 24 months|||mm||Standard Deviation|Mean
19780|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
19781|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
19782|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
19783|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Nm/kg||Standard Deviation|Mean
19784|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks|||Newton meters (Nm)/kg||Standard Deviation|Mean
19785|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup|The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks|||Pushups||Standard Deviation|Mean
19786|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up|The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks|||Sit-ups||Standard Deviation|Mean
19787|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip|The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.|Baseline and 24 weeks|||kg||Standard Deviation|Mean
19788|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion|The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.|Baseline and 24 weeks|||degrees||Standard Deviation|Mean
19789|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach|The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups|Baseline and 24 weeks|||cm||Standard Deviation|Mean
19790|NCT01778127|Secondary|Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks|The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.|Baseline and 24 weeks|||ml/kg/min||Standard Deviation|Mean
19791|NCT01778127|Primary|Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups|The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.|Baseline, Week 24|||minutes||Standard Deviation|Mean
19792|NCT01778062|Secondary|Incidence of COPD Exacerbation|Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug||Participants|||Number
19793|NCT01778062|Secondary|Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.||Score on a scale||Standard Deviation|Mean
19794|NCT01778062|Secondary|St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment|The SGRQ-C contains 14 questions divided into two components. Part 1 produces “Symptoms” scores and Part 2 “Activity” and “Impacts” scores. 14 questions which are divided in three domains: “symptom” (question 1-7), “activity” (question 9, 12) and “impact” (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.||Score on a scale||Standard Deviation|Mean
19795|NCT01778062|Primary|Trough Forced Expiratory Volume in One Second Change|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.||Liters||Standard Deviation|Mean
19796|NCT01778049|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.|Baseline and 24 weeks|FAS (OC)||mmol/L||Standard Error|Least Squares Mean
19797|NCT01778049|Primary|Change From Baseline of HbA1c After 24 Weeks of Treatment.|"Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term “baseline” was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as “pre-treatment. Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.~Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial."|Baseline and 24 weeks|FAS (OC)||Percentage of HbA1c||Standard Error|Least Squares Mean
19832|NCT01777776|Secondary|Phase Ib/II - Plasma Concentration-time Profiles|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to plasma concentration time profiles were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
19798|NCT01778023|Secondary|Ht-V (Height Velocity)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.|At the first 6 months and the last 6 months in group A|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.||cm/year||95% Confidence Interval|Least Squares Mean
19799|NCT01778023|Secondary|Occurrence of Adverse Events|AEs were collected throughout the trial in both groups.|Throughout the trial (12 months)|Safety analysis set – includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.||events|||Number
19800|NCT01778023|Secondary|Change in Bone Age|Change in bone age from the baseline to 6 months.|After 6 months of treatment.|Safety analysis set (SAS) :includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.||years||Standard Deviation|Mean
19801|NCT01778023|Secondary|Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)|IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.||mcg/mL||Standard Error|Least Squares Mean
19802|NCT01778023|Secondary|Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)|IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.||ng/ml||Standard Error|Least Squares Mean
19803|NCT01778023|Secondary|Change in Ht-SDS (Height Standard Deviation Score)|Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
19804|NCT01778023|Primary|Height Velocity (Ht-V)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.|After 6 months of treatment|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.||cm/year||Standard Error|Least Squares Mean
19805|NCT01777945|Secondary|Number of Participants With Adverse Events||approximately 2 years|46 participants enrolled in the study were evaluable with regards to tolerability; however, 1 participant did not meet the eligibility criteria, was excluded from the efficacy analyses, but was included in the safety analyses.||participants|||Number
19806|NCT01777945|Secondary|Percentage of Capecitabine Dose Modifications||approximately 2 years|||percentage of doses|||Number
19807|NCT01777945|Secondary|Duration of Treatment With Xeloda||approximately 2 years|||treatment cycle||Standard Deviation|Mean
19808|NCT01777945|Secondary|Clinical Benefit Rate|The percentage of participants with an overall response (complete or partial remission) or with stable disease.|approximately 2 years|||percentage of participants|||Number
19809|NCT01777945|Secondary|Overall Response Rate|The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.|approximately 2 years|||percentage of participants|||Number
19810|NCT01777945|Secondary|Time to Treatment Failure|The time from enrollment to discontinuation of any drug of the treatment combination.|approximately 2 years|||months||Standard Deviation|Mean
19811|NCT01777945|Primary|Progression-free Survival (PFS)|The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.|approximately 2 years|||months||Standard Deviation|Median
19812|NCT01777932|Secondary|Participants With Proteinuria at Study Entry (Baseline)|The number of participants with proteinurea status as positive, negative or missing is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure||participants|||Number
19813|NCT01777932|Secondary|Participants With Type of Metastases at Study Entry (Baseline)|The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
19814|NCT01777932|Secondary|Participants With Disease History at Study Entry (Baseline)|Participant’s history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
19815|NCT01777932|Secondary|Participants With Prior Therapy at Study Entry (Baseline)|The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure||participants|||Number
19833|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Serious Adverse Event (SAE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.||participants|||Number
19834|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Adverse Event (AE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.||participants|||Number
19816|NCT01777932|Secondary|Participants With Eastern Cooperative Oncology Group Status at Study Entry|The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
19817|NCT01777932|Secondary|Participants With Tumor Stage at Diagnosis|Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
19818|NCT01777932|Secondary|Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry|PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status.|Approximately 5 years|All enrolled participants were considered for this outcome measure. Out of the total 220 enrolled participants, 106 participants were triple negative, 110 were not triple negative and data for 4 participants were missing.||months||95% Confidence Interval|Median
19819|NCT01777932|Secondary|Participants With Hormone Receptor Status at Diagnosis|The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.||participants|||Number
19820|NCT01777932|Secondary|Time to Discontinuation (TTD) of Bevacizumab Treatment|Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
19821|NCT01777932|Secondary|One Year Survival|The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.|Approximately 5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
19822|NCT01777932|Primary|Progression Free Survival|Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
19823|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Racc|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
19824|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Tmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
19825|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
19826|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmin|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
19827|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: AUCtau|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||||
19828|NCT01777776|Secondary|Phase II - Overall Survival (OS)|"OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
19829|NCT01777776|Secondary|Phase Ib/II - Duration Of Response (DOR)|"DOR is calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
19830|NCT01777776|Secondary|Phase Ib/II - Progression Free Survival (PFS)|"PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
19831|NCT01777776|Secondary|Phase Ib/II - Overall Response Rate (ORR)|"ORR is defined as the proportion of patients with a best overall response of complete response or partial response.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
19835|NCT01777776|Primary|Phase II - Objective Response Rate (ORR)|"As per RECIST v1.1, ORR is defined as the proportion of patients with a best overall response of complete response or partial response.~Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
19836|NCT01777776|Primary|Phase II - Progression Free Survival (PFS)|"As per RECIST v1.1, PFS is the time from date of randomization/ start of treatment to the date of event defined as the first documented progression or death due to any cause.~Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.|||||
19837|NCT01777776|Primary|Phase Ib - Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1|"Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818.~Due to the halt of enrollment, no Maximum Tolerated Dose (MTD) was formally declared during the study."|Cycle 1 (approximately 28 days)|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.||participants with DLTs|||Number
19838|NCT01777763|Other Pre-specified|Number of Participants Discontinuing Study Treatment Due to an AE|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. These AEs resulted in participants stopping study drug treatment. This measure includes participants who discontinued due to AEs and also includes treatment failures that were attributed to AEs.|Up to Day 28|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
19839|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Related AEs|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-related AEs were considered by the investigator to be related to the study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
19840|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-emergent AEs are any events not present before starting study drug treatment or any events that were present before treatment that worsened in either intensity or frequency after exposure to study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
19841|NCT01777763|Other Pre-specified|Number of Participants Surviving at Day 65|Number of Participants Alive at Day 65|Day 65|The safety population consisted of all participants who received at least one dose of study drug.||Participants|||Number
19842|NCT01777763|Primary|Apparent Total Body Clearance (CL/F) for Posaconazole Tablet|Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The CL/F PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through predose on the Day 8 steady-state visit.||L/hr||Standard Deviation|Mean
19843|NCT01777763|Primary|Time to Maximum Concentration (Tmax) of Posaconazole Tablet|Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Tmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||Hours||Full Range|Median
19844|NCT01777763|Primary|Maximum Concentration (Cmax) of Posaconazole Tablet|Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||ng/mL||Standard Deviation|Mean
19845|NCT01777763|Primary|Minimum Concentration (Cmin) of Posaconazole Tablet|Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous day's dose of study drug.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmin PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||ng/mL||Standard Deviation|Mean
19846|NCT01777763|Primary|Average Concentration (Cavg) of Posaconazole Tablet|"Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval.~Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose."|Predose on Day 1 up to 24 hours postdose on Day 8|The Cavg PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.||ng/mL||Standard Deviation|Mean
19847|NCT01777620|Secondary|Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS|The Investigator assessed the severity of the patient’s CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.|Baseline, Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19848|NCT01777620|Secondary|Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS|The Investigator assessed the severity of the patient’s glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.|Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19849|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19850|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19851|NCT01777620|Secondary|Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19852|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19853|NCT01777620|Secondary|Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19854|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19855|NCT01777620|Secondary|Percentage of Participants Satisfied With Treatment of Crow’s Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19856|NCT01777620|Primary|Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)|Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.||Percentage of participants|||Number
19857|NCT01777581|Secondary|State-trait Anxiety Inventory (STAI)|"Self-report evaluation of anxiety symptoms.Assessment of subjective symptoms of current anxiety and chronic anxiety.~There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” All items are rated on a 4-point scale~Scale~1= almost never 4= almost always~Higher scores indicate greater anxiety. Mean cumulative scores were reported"|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
41624|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban After Three Days of 5 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
19858|NCT01777581|Secondary|Beck Depression Inventory (BDI-II)|"Self-report evaluation of depressive symptoms.The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression. The higher the score the degree of depression."|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
19859|NCT01777581|Secondary|Neuropathic Pain Questionnaire|"Self-report evaluation of nerve pain symptoms. A low total cumulative score means less pain and higher cumulative score is greater pain.~Total cumulative scores range form 0 to 1000 where in 0 is absence of pain and 1000 highest pain."|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
19860|NCT01777581|Secondary|Oswestry Low Back Pain Disability Questionnaire|"Self report evaluation of various back pain symptoms. For each of 10 sections participants rate pain on a scale of 0-5 in these categories:~Section 1 – Pain intensity~Section 2 – Personal care~Section 3 – Lifting~Section 4 – Walking~Section 5 – Sitting~Section 6 – Standing~Section 7 – Sleeping~Section 8 – Sex life (if applicable)~Section 9 – Social life~Section 10 – Travelling~The scores are combined form each category into overall score. Scores are converted to percentages as follows:~0% to 20%: minimal disability: The patient can cope with most living activities.~21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing.~41%-60%: severe disability: Pain remains the main problem-activities of daily living are affected.~61%-80%: crippled: Back pain impinges on all aspects of life.~81%-100%: Patients are either bed-bound or exaggerating their symptoms"|baseline and 10 weeks|||percent score||Standard Deviation|Mean
19861|NCT01777581|Secondary|SF-36 (Short Form)|"Self-report of quality of life. Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.~Scoring: Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores reflect higher quality of life with 100 high life quality. Total mean cumulative scores were reported~The eight sections are:~vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health"|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
19862|NCT01777581|Secondary|VAS Related to Nociceptive Pain Component (VAS-Noc)|The secondary outcome is change in pain VAS from baseline through 1o weeks as related to nociceptive pain component. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative scores were reported|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
19863|NCT01777581|Primary|Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)|The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.|baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
19864|NCT01777438|Secondary|Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis|"ARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis.~Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR"|3 years after diagnosis|||percentage of participants|||Number
19865|NCT01777438|Primary|Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation.|Visual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points.|3 years after diagnosis|||Score on a scale||Standard Deviation|Mean
19866|NCT01777438|Secondary|Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment|Based on the proposed cut-off value of VAS < 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients|3 years after starting SCIT|||percentage of participants|||Number
19867|NCT01777438|Primary|Current Medication Use Three Years After Diagnosis of AR|Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group)|3 years after starting SCIT|||percentage of participants|||Number
19868|NCT01777425|Other Pre-specified|Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group|"VAS scores: a measurement of patient’s subjective evaluation by indicating a position on a line between two endpoints. Patients will score eight individual symptoms on a scale from 0 until 10, being 0 no trouble and 10 maximum trouble. Finally a mean symptom score will be calculated per symptom.~The SNOT-22 questionnaire is a validated 22 item questionnaire. patients indicate how much they are affected in eight different areas and identify the 5 most important items. The SNOT-22 total score can range from 0 to 110, with higher scores representing worse quality of life.~Perceived health status can be evaluated by the 36-item short-form (SF-36). It consists of 36 items covering eight domains. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability"|three years after ESS|||units on a scale||Standard Deviation|Mean
19869|NCT01777425|Secondary|Control Nasal Endoscopy|Evaluating of difference in control if nasal endoscopy is performed three years after ESS.|3 years after ESS|fully controlled status with endoscopic evaluation||percentage of participants|||Number
19870|NCT01777425|Primary|Control Status of Patients With Rhinosinusitis|1. Percentage of patients with rhinosinusitis that are fully controlled, partly controlled and uncontrolled according to the new european position paper on rhinosinusitis (EPOS) definitions at a mean interval of 3 years after endoscopic sinus surgery.|3 years after FESS|||percentage of participants|||Number
20184|NCT01769443|Secondary|Incidence of Severe Infection Requiring Intravenous Antibiotics||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
19871|NCT01777412|Primary|Follow-Up Expanded Disability Status Score (EDSS)|"EDSS~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Follow-up visit 91 days after admission|||units on a scale||Inter-Quartile Range|Median
19872|NCT01777412|Primary|Safety Assessment and Side Effects|Frequency and severity of adverse events and side effects. Serious adverse events are considered those which are life threatening, lead to hospitalization and related to the drug. Side effects are considered minor effects of the experimental drug that do not significantly impact the care of the patient with the experimental drug.|91 days|||participants|||Number
19873|NCT01777412|Primary|Baseline Expanded Disability Status Score (EDSS)|"EDSS~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Admission to hospital|||units on a scale||Inter-Quartile Range|Median
19874|NCT01777334|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as the WM value at that visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
19875|NCT01777334|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 140, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes (min) pre-dose and 5 min pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hr after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 value at that visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessmentsmade 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug during the Treatment Period. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
19876|NCT01777321|Secondary|Number of Subjects With SAEs||Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
19877|NCT01777321|Secondary|Number of Subjects With pIMDs||Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
19878|NCT01777321|Secondary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|Twelve Months after Dose 2 (M14)|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.||Subjects|||Number
19879|NCT01777321|Secondary|Anti-gE Antibody Concentrations||At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.||mIU/mL||95% Confidence Interval|Geometric Mean
19880|NCT01777321|Secondary|Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL||At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.||Subjects|||Number
19881|NCT01777321|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 30 days post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
19882|NCT01777321|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
19883|NCT01777321|Primary|Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)||Up to 30 days post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
19884|NCT01777321|Primary|Number of Days With General Symptoms||During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Days||Inter-Quartile Range|Mean
19885|NCT01777321|Primary|Number of Days With Local Symptoms||During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Days||Inter-Quartile Range|Mean
19886|NCT01777321|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature >39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
19887|NCT01777321|Primary|Number of Subjects With Solicited Local Symptoms|The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.||Subjects|||Number
19888|NCT01777321|Primary|Anti-gE Antibody Concentrations||Before vaccination (PRE), at two months after dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||mIU/mL||Standard Deviation|Median
19889|NCT01777321|Primary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|At two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
19890|NCT01777321|Primary|Anti-gE Antibody Concentrations||Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
19891|NCT01777321|Primary|Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations ≥ 18 mIU/mL||Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
19892|NCT01777282|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to <Week 12 or >=230 mg/dL (>=12.8 mmol/L) from >=Week 12 to <Week 52.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.||Weeks||Standard Deviation|Mean
19893|NCT01777282|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population||Kilograms (kg)||Standard Deviation|Mean
19894|NCT01777282|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only those participants with valid post-Baseline results (within 14 days of last exposure to treatment) were analyzed.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
19895|NCT01777282|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population||Percentage of participants|||Number
19906|NCT01777191|Secondary|PK: AUC 0-tlast by Body Weight|AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: <80 kg, Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.||µg*day/mL||90% Confidence Interval|Geometric Mean
22363|NCT01729026|Secondary|Alcohol Use Disorders Identification Test (AUDIT-C)|Self-rating scale that assesses the frequency and extent of alcohol use|Baseline and 1-month, 3-month, 4-month, and 6-month follow-ups||||||
19896|NCT01777282|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population: all enrolled participants who received at least 1 dose of study medication and who had at least one HbA1c post-Baseline assessment.||Percentage of HbA1c in the blood||Standard Deviation|Mean
19897|NCT01777282|Primary|Number of Participants With Any Hypoglycemic Event|Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.||Participants|||Number
19898|NCT01777282|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.||Participants|||Number
19899|NCT01777217|Primary|Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).|The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.|baseline and 16 weeks|||Scores on a scale||Standard Deviation|Median
19900|NCT01777191|Secondary|SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)|"The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from Strongly Disagree to Strongly Agree). 1 represents Strongly Disagree while 7 represents Strongly Agree. The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit."|Baseline, Week 4 and Week 8|All randomized participants.||units on a scale||Standard Deviation|Mean
19901|NCT01777191|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received a least 1 dose of study drug during the Treatment Period and had evaluable data.||percentage of participants|||Number
19902|NCT01777191|Secondary|Percentage of Device Operation Failures|Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.|Baseline through Week 12|All randomized participants.||percentage of incomplete injections|Participants||Number
19903|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
19904|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
19905|NCT01777191|Secondary|Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)|PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
41625|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban After Three Days of 5 mg IV Daily in HRS Type 2 Patients||3 days|||hr||Standard Deviation|Mean
19907|NCT01777191|Secondary|PK: Cmax by Body Weight|Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: <80 kilogram (kg), Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.||µg/mL||95% Confidence Interval|Geometric Mean
19908|NCT01777191|Secondary|PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)|AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.||µg*day/mL||90% Confidence Interval|Geometric Mean
19909|NCT01777191|Secondary|PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)|Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.||µg/ml||90% Confidence Interval|Geometric Mean
19910|NCT01777191|Primary|PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device|AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.||micrograms*day/milliliter (µg*day/mL)||90% Confidence Interval|Geometric Mean
19911|NCT01777191|Primary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device|Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.||micrograms/milliliter (µg/mL)||90% Confidence Interval|Geometric Mean
19912|NCT01777126|Secondary|Severity Grade of Postoperative Complications.|Severity grade of postoperative complications (POCs) was compared between the two groups. The severity grade of POCs were classified using the Clavien-Dindo Classification. Per patient, multiple complications are possible.|30 days postoperative|||number of POCs per severity grade|||Number
19913|NCT01777126|Secondary|The Type of Postoperative Complications.|The type of postoperative complications (POCs) were compared between the two groups. The type of POCs were classified using the Clavien-Dindo Classification. Herein POCs were classified into 8 categories (1. Infection, 2. Fistula/leak, 3. Bleeding/hematoma, 4. Gastrointestinal, 5. Cardiopulmonary, 6. Neurologic, 7. pain and 8. Other) and stratified by their severity grade (Table 2). Per patient, multiple complications are possible.|30 days postoperative|||number per type of POC|||Number
19914|NCT01777126|Secondary|Patients With a Catheter Related Bloodstream Infection|Patients with a catheter related bloodstream infection were compared between the two groups|30 days postoperative|||participants|||Number
19915|NCT01777126|Secondary|The Number of Postoperative Complications Per Patient.|The number of postoperative complications per patient was compared between the two groups.|30 days postoperative|||number of postoperative complications||Inter-Quartile Range|Median
19916|NCT01777126|Secondary|Patients With One or More Postoperative Complication.|Number of patients with one or more postoperative complication were compared betweent the two groups.|30 days postoperative|||participants|||Number
19917|NCT01777126|Secondary|The Time to Resumption of Full Diet.|The time to resumption of full diet between the two groups was compared.|30 days postoperative|||day||Inter-Quartile Range|Median
19918|NCT01777126|Secondary|Number of Administered PN|Number of administered PN per group|30 days postoperative|||number of PN|||Number
19919|NCT01777126|Secondary|Successful Implementation Rate of the ONP in the Experimental Group|Successful implementation of the ONP was achieved if the patient followed the protocol and did not need PN.|30 days postoperative|The number of patients with successful implementation of the ONP in the experimental group.||participants|||Number
19920|NCT01777126|Primary|the Postoperative Length of Stay|The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home.|one month after surgery|Primary outcome measure was interval from surgery to discharge. Discharge means that the patient returns back to his home and not to a rehabilitation center.||day||Inter-Quartile Range|Median
19921|NCT01776645|Secondary|Change in Brief Pain Inventory|Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes|Baseline to end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain||units on a scale||Standard Deviation|Mean
19922|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Pommier's Compassion for Other's Scale|Baseline and end of 9-week treatment protocol||||||
19923|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Compassionate Love Scale adapted for close other|Baseline and end of 9-week treatment protocol||||||
19924|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by PROMIS Global Health Scale|Baseline and end of 9-week treatment protocol||||||
19925|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the PROMIS Social Isolation Scale|Baseline and end of 9-week treatment protocol||||||
19926|NCT01776645|Other Pre-specified|Change in Emotional Distress|As Assessed by the PROMIS Anger Scale|Baseline and end of 9-week treatment protocol||||||
19927|NCT01776645|Other Pre-specified|Qualitative Measures|Qualitative analysis of interviews|Baseline and end of 9-week treatment protocol||||||
19928|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Neff's Self-Compassion Scale|Baseline and end of 9-week treatment protocol||||||
19929|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by Ryff's psychological well-being scales|Baseline and end of 9-week treatment protocol||||||
19930|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the Hospital Anxiety and Depression Scale|Baseline and end of 9-week treatment protocol||||||
19931|NCT01776645|Primary|Change in Chronic Pain Acceptance Questionnaire||Baseline and end of 9-week treatment protocol||||||
19932|NCT01776645|Primary|Change in Brief Pain Inventory|Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable|Baseline and end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain||units on a scale||Standard Deviation|Mean
19933|NCT01776554|Secondary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 9 to <18 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done the FAS.||Percentages of subjects||95% Confidence Interval|Number
19934|NCT01776554|Secondary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 3 to <9 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
19935|NCT01776554|Secondary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 6 to <36 months achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
19936|NCT01776554|Secondary|Percentages Of Subjects Aged 9 to <18 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 9 to <18 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
19937|NCT01776554|Secondary|Percentages Of Subjects Aged 3 to <9 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 3 to <9 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
19938|NCT01776554|Secondary|Percentages Of Subjects Aged 6 to <36 Months, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 6 to <36 months, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
19939|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 9 to <18 Years.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 9 to <18 years is reported.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
19940|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 3 to <9 Years.|"Immunogenicity was measured as geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 3 to <9 years is reported.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
19978|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using alcohol|||Number
20185|NCT01769443|Secondary|Incidence of Initiation of Any Mechanical Circulatory Support Device||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
19941|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 6 to <36 Months.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 6 to <36 months is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
19942|NCT01776554|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination; SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset.||Number of subjects|||Number
19943|NCT01776554|Primary|Number of Subjects (≥6 Years – 17 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset.||Number of subjects|||Number
19944|NCT01776554|Primary|Number of Subjects (6 Month - <6 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after each vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
19945|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 9 to <18 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
19946|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 3 to <9 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
19947|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 6 to <36 months, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done was FAS.||Percentages of subjects||95% Confidence Interval|Number
19948|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 9 to <18 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
19949|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 3 to <9 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.||Percentages of subjects||95% Confidence Interval|Number
19979|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using alcohol|||Number
19980|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline|||percentage using alcohol|||Number
19950|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 6 to <36 months, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually received at least one dose of study vaccination and provided at least one evaluable serum sample both before (baseline) and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
19951|NCT01776541|Secondary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as: a) for subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) for subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS set.||Percentages of subjects||95% Confidence Interval|Number
19952|NCT01776541|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS set.||Percentages of subjects||95% Confidence Interval|Number
19953|NCT01776541|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5 for subjects 18-60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS set.||Ratio||95% Confidence Interval|Geometric Mean
19954|NCT01776541|Primary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
19955|NCT01776541|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.|Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
19956|NCT01776541|Primary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.~Seroconversion is defined as either a) in subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion for the adult population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS population.||Percentages of subjects||95% Confidence Interval|Number
19957|NCT01776541|Primary|Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
19958|NCT01775995|Other Pre-specified|Pain Sensitivity to Experimental Thermal Stimuli|Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.|0, 8, 26 weeks||||||
20020|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.||units per kilogram (units/kg)||Standard Error|Least Squares Mean
19959|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.~Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.~Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|From enrollment to 26 week follow-up (6 months)|One meditation-CBT participant did not provide data at 8-week follow-up; two participants (one meditation-CBT, one control) did not provide data at 26-week follow-up. All 35 participants were included in the analysis; missing participant data was imputed based on existing data for the given participant.||dollars||Standard Deviation|Mean
19960|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.~Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.~Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|6 months prior to baseline, to baseline (enrollment)|||dollars||Standard Deviation|Mean
19961|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure)."|baseline to 26 weeks|Six Meditation-CBT participants and one Wait-list Control participant did not provide biological data at 26 week follow-up. Results for this measure are based on the number of participants analyzed.||mg/dL||95% Confidence Interval|Mean
19962|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure)."|baseline to 8 weeks|Three Meditation-CBT participants did not provide biological data at 8 week follow-up. Results for this measure are based on the number of participants analyzed.||mg/dL||95% Confidence Interval|Mean
19963|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19964|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19965|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19966|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
20021|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.||units||Standard Error|Least Squares Mean
19967|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19968|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19969|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19970|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19971|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19972|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19973|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19974|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19975|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using drugs|||Number
19976|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.||percentage using drugs|||Number
19977|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline|||percentage using drugs|||Number
22823|NCT01721096|Secondary|Composite Endpoint of Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|1 year post index procedure|||percentage of participants|||Number
19981|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||morphine-equivalent mg/day||95% Confidence Interval|Mean
19982|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||morphine-equivalent mg/day||95% Confidence Interval|Mean
19983|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||percentage disability||95% Confidence Interval|Mean
19984|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||percentage disability||95% Confidence Interval|Mean
19985|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19986|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.||units on a scale||95% Confidence Interval|Mean
19987|NCT01775852|Secondary|Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up.|"The WHODAS contains 36 items on functioning and disability with a recall period of 30 days covering 7 domains: Understanding and Communicating (6 items), Getting around (5 items), Self-care (4 items), Getting along with others (5 items), Life activities: household (4 items), Life activities: work/school (4 items), and Participation in society (8 items). Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do).~WHODAS domain scores are computed for each domain by adding the item responses together. A global score is then computed by summing all domains together, and transforming them into a range from 0 to 100, with higher scores indicating higher levels of disability (0= no disability, 100= full disability)."|Change at 12 week follow-up from baseline|||units on a scale||Standard Error|Mean
19988|NCT01775852|Secondary|Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up.|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.~The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|Change at 12 week follow-up from baseline|||units on a scale||Standard Error|Mean
19989|NCT01775852|Secondary|Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.|"The HDI is useful in assessing the impact of headache, and its treatment, on daily living. 25 self-report items are rated with answers as Yes (4 points), Sometimes (2 Points), and No (0 points). All items are then added together to create an overall score which can range from 0 (no impact), to 100 (severe impact) of headache on daily life.~A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects."|12 week change from baseline|||units on a scale||Standard Error|Mean
20022|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.||kilograms (kg)||Standard Error|Least Squares Mean
19990|NCT01775852|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale at 12 week (3 month) follow-up from baseline.~Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|12 week change from baseline|||units on a scale||Standard Error|Mean
19991|NCT01775137|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalisation, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.||Number of participants|||Number
19992|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The day of first hospitalization due to serious respiratory related adverse events was analysed using Kaplan Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
19993|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The total number of hospitalisation days due to serious respiratory-related adverse events was analysed using Kaplan-Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Days||Full Range|Median
19994|NCT01775137|Secondary|Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the extension study.|Baseline of extension study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
19995|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics in Extension Study|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
19996|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively||Days||Full Range|Median
19997|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
19998|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Absolute change was calculated by using the formula = (Value at actual time point - start of extension value).|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||log10 CFU||Standard Deviation|Mean
19999|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant’s age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted – baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percent change in FEV1 % predicted||Standard Deviation|Mean
20024|NCT01774968|Secondary|Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24|The percentage of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.|Week 24|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data.||percentage of participants|||Number
20186|NCT01769443|Secondary|Incidence of Removal From Transplant Waiting List for Any Reason Except Improvement of Cardiac Function||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20000|NCT01775137|Secondary|Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. Relative change in FEV1 % predicted was calculated by using the formula = 100 *(30-min post-dose value - pre-dose value) / pre-dose value.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percent change in FEV1 % predicted||Standard Deviation|Mean
20001|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The day of first hospitalization due to serious respiratory-related adverse events was analysed using Kaplan Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
20002|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed using Kaplan-Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Days||Full Range|Median
20003|NCT01775137|Secondary|The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
20004|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Days||95% Confidence Interval|Median
20005|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Days||Full Range|Median
20006|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.||Percentage of participants|||Number
20007|NCT01775137|Secondary|Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles|MIC was defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation. Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested (mucoid,dry and small colony variant biotypes).|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||micrograms/milliliters|||Number
20008|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Absolute change was determined using the formula = (Post-baseline value- baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day|||log 10 CFU/g||Standard Deviation|Mean
20009|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant’s age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted – baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percent change in FEV1 % predicted||Standard Deviation|Mean
20023|NCT01774968|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.||events per participant per 30 days||Standard Deviation|Mean
20187|NCT01769443|Secondary|Incidence of Death||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20010|NCT01775137|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in core study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.||Participants|||Number
20011|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.||kg||Standard Error|Least Squares Mean
20012|NCT01774968|Secondary|Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or >2.0 U/kg). The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.||percentage of participants|||Number
20013|NCT01774968|Secondary|Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.||events per participant per 30 days||Standard Deviation|Mean
20014|NCT01774968|Secondary|Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.||percentage of HbA1c||Standard Error|Least Squares Mean
20015|NCT01774968|Secondary|Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)|The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable SMBG data.||mg/dL||Standard Error|Least Squares Mean
20016|NCT01774968|Secondary|Change From Baseline to Week 24 in Number of Insulin Injections|The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R. Last observation carried forward (LOCF) was used to impute missing postbaseline values.||injections per day||Standard Deviation|Mean
20017|NCT01774968|Secondary|Percentage of Participants With Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.||percentage of participants|||Number
20018|NCT01774968|Secondary|Time to Reach HbA1c Target Values|The cumulative number of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% is summarized at Weeks 6, 12, 18, and 24. The number of participants at risk (n) is also provided for each target value and timepoint.|Baseline through 6, 12, 18, and 24 weeks.|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data||participants|||Number
20019|NCT01774968|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable FPG data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
20025|NCT01774968|Primary|Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.||percentage of HbA1c||Standard Error|Least Squares Mean
20026|NCT01774929|Secondary|Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30|The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Baseline, Day 15 and Day 30|"ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. N” signifies those participants who were evaluated for this outcome measure."||Units on a scale||Standard Deviation|Mean
20027|NCT01774929|Primary|Pain Intensity Score at Day 30|The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.||cm||Standard Deviation|Mean
20028|NCT01774929|Primary|Pain Intensity Score at Day 15|The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.|Day 15|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.||cm||Standard Deviation|Mean
20029|NCT01774903|Secondary|Number of Participants With Participant Global Assessment|Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=Mild, 3=Moderate, 4=Severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|PP population included all participants who completed the 30-day study.||participants|||Number
20030|NCT01774903|Secondary|Number of Participants With Investigator Global Assessment|Investigator completed a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|Per protocol (PP) population included all participants who completed the 30-day study.||participants|||Number
20031|NCT01774903|Primary|Pain Intensity at Day 30|Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
20032|NCT01774903|Primary|Pain Intensity at Day 15|Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 15|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
20033|NCT01774604|Secondary|Number of Patients With 30 Days Hospital Re-admission|Number of patients admitted to the hospital for any cause following ERCP|From randomization until 30 days after ERCP|||participants|||Number
20034|NCT01774604|Secondary|Number of Patient Deaths|Number of patients who died from any cause from the time of ERCP until 30 days post-procedure|From randomization to 30 days after ERCP|||participants|||Number
20035|NCT01774604|Secondary|Number of Patients Who Developed Gastrointestinal Bleeding|Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure|From randomization to 30 days after ERCP|||participants|||Number
20036|NCT01774604|Secondary|Number of Patients Who Developed Mild Pancreatitis|Number of patient who developed mild acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP|||participants|||Number
20037|NCT01774604|Secondary|Number of Patients Who Developed Moderately Severe Pancreatitis|Number of patients with moderately severe pancreatitis based on Atlanta Classification|From randomization to 30 days after ERCP|||participants|||Number
20038|NCT01774604|Secondary|Number of Patients Who Developed Severe Pancreatitis|Number of patients with severe acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP|Assess the number of patients who developed severe acute pancreatitis||participants|||Number
20039|NCT01774604|Primary|Number of Patients Who Developed Acute Pancreatitis|Number of patients who developed pancreatitis following ERCP based on Atlanta Classification|From randomization to 30 days after ERCP|Patient who randomized into the study and received either rectal indomethacin or placebo||participants|||Number
20040|NCT01774305|Secondary|Emergence Time|The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.|from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)|||sec||Standard Deviation|Mean
20041|NCT01774305|Primary|Coughing Grade|The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).|from the time of eye opening to 5 min after extubation|||units on a scale||Standard Deviation|Mean
20042|NCT01774253|Secondary|Determine the Response Rates of Participants Based on Activation (or no Activation) of Their Hedgehog Signaling Pathway|To determine the objective response rates (partial and complete response) for patients without and with evidence of activation of Hedgehog signaling pathway in their tumors|3 years|No samples collected for hedgehog pathway. No data exists.|||||
20043|NCT01774253|Secondary|Evaluate the Impact of Quality of Life of Children Receiving Vismodegib Using PedsQL Questionnaires|Evaluate the impact of Quality of Life of children receiving Vismodegib using PedsQL questionnaires|2 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
20044|NCT01774253|Secondary|Determine the Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|2 years|Not evaluated due to early closure. Study data does not exist.|||||
20045|NCT01774253|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety and tolerability of Vismodegib as a single agent in pediatric and young adult patients with refractory or recurrent pontine glioma|2 years|||participants|||Number
20046|NCT01774253|Primary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|5 years|||Days|||Number
20047|NCT01774149|Other Pre-specified|Empowerment|Diabetes Empowerment Scale-Short Form (DES-SF) will be used to assess empowerment at the start of the study (week 1 post-enrollment) and during week 12 of intervention.|Up to 12 weeks post-enrollment.||||||
20048|NCT01774149|Other Pre-specified|Usability|System Usability Scale (SUS) will be applied to assess usability of the approach and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment||||||
20049|NCT01774149|Secondary|Change in HbA1c|HbA1c will be measured at the start of the study (week 1 post-enrollment) and during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment|11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded.||Percentage points||95% Confidence Interval|Mean
20050|NCT01774149|Primary|Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.|The number of self-measured blood glucose values < 4 mmol/L (72 mg/dL) or > 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.|Up to 12 weeks post-enrollment|14 participants in each group were active users and had sufficient data to be analyzed for the outcome.||Events||95% Confidence Interval|Mean
20051|NCT01774110|Other Pre-specified|Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment|The 6-Minute Walk Test is a test of walking endurance and walking velocity.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment|||feet||Standard Deviation|Mean
20052|NCT01774110|Secondary|Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.|The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke. There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section. Each section is scored independently and is normed to 100 points. Each of the 3 sections is then combined into a total overall function score which is also normed to 100. Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment|||scores on a scale||Standard Deviation|Mean
20053|NCT01774110|Primary|Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment|Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.|This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.|||cm/sec||Standard Deviation|Mean
20054|NCT01774084|Secondary|Change in Beta Cell Function|Beta cell function is measured with intravenous glucose tolerance test (IVGTT)|Morning before surgery and up to two days after surgery|||Insulin AUC nmol * min/L||Standard Deviation|Mean
20055|NCT01774084|Primary|Change in Insulin Sensitivity|Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp|Morning before surgery and up to two days after surgery|Per protocol||mg/(kg min)||Standard Deviation|Mean
20056|NCT01774045|Primary|Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.|baseline to 72 hours|||participants|||Number
20057|NCT01774045|Primary|Number of Dose Limiting Toxicity of Laboratory Values|Laboratory tests are composed of hematology and blood chemistry and measured at each visit. Hematology are composed of RBC, WBC, platelets, hematocrit, hemoglobin, prothrombin time (PT) and partial thromboplastin time (aPTT). Blood chemistry are composed of AST, ALT, LDH, total bilirubin, BUN, serum creatinine, free thyroxine (FT4), TSH, sodium, calcium, potassium, glucose, LDL, HDL, cholesterol and HbA1c.|baseline to 72 hours|||participants|||Number
20058|NCT01774045|Primary|Number of Dose Limiting Toxicity of Vital Sign|Vital sign, including heart rate, blood pressure and body temperature, are measured at each visit and at 1,2,3,4,8,12 and 24 hours after drug administration.|baseline to 72 hours|||participants|||Number
20059|NCT01774045|Primary|Number of Dose Limiting Toxicity of Electrocardiograph|Electrocardiograph (ECG) is measured at each visit. At visit 2, subjects were measured at 1,2, 4, 8, 12 and 24 hours after drug administration.|baseline to 72 hours|||participants|||Number
20060|NCT01774045|Primary|Number of Dose Limiting Toxicity of Physical Examination|Physical examination, including skin, head, neck, eyes, ears, nose, throat, heart, lungs, abdomen (liver and spleen), neurological examination, lymph node and extremities, is measured at each visit from screening to follow-up.|baseline to 72 hours|||participants|||Number
20061|NCT01773135|Primary|Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor|measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor|9 weeks|||pg/ml||Inter-Quartile Range|Median
20062|NCT01773122|Secondary|Maximum Plasma Level (Cmax) of Dapsone Metabolites|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.|Day 28|All treated subjects with data for this time point||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
22824|NCT01721096|Secondary|Composite Endpoint of Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|8 months post index procedure|||percentage of participants|||Number
20063|NCT01773122|Primary|Maximum Plasma Level (Cmax) of Dapsone|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.|Day 28|All treated subjects with data for this time point||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
20064|NCT01773889|Primary|Clinical Response Rate|Although positive clinical response criteria are based on RECIST criteria, failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have been written to avoid stopping therapy prematurely without compromising patient safety, to accommodate the uncertainties of assessing failure in this setting. The criteria as written are based on sound medical, scientific and ethical principles. The trial is further designed to help establish the utility of these novel criteria.|every 3 months until the date of first documented progression or date of death from any cause, assessed up to 10 years|||participants|||Number
20065|NCT01773473|Secondary|Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 1,5-AG measurements.||micrograms/milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
20066|NCT01773473|Secondary|Insulin Dose at Week 26|Insulin dose is the total daily dose including basal and prandial doses.|Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had Week 26 insulin dose measurement.||units of insulin per day (IU/day)||Standard Deviation|Mean
20067|NCT01773473|Secondary|Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005].|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug.||events|||Number
20068|NCT01773473|Secondary|Change From Baseline in Body Weight at Week 26|LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and had baseline and Week 26 body weight measurements.||kilogram (kg)||95% Confidence Interval|Least Squares Mean
20069|NCT01773473|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 FBG measurement.||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
20070|NCT01773473|Secondary|Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and at least 1 post-baseline HbA1c measurement.||percentage of participants|||Number
20071|NCT01773473|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 HbA1c measurements.||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
20072|NCT01773291|Secondary|Muscle Power (MP)|"Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement~Flicker of movement only~Movement possible when assisted by gravity or gravity is eliminated~Movement possible against gravity but without imposed resistance~Weak movement possible against gravity~Normal movement against gravity and against imposed resistance~The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The MP was measured before and after treatment during hospitalization.||units on a scale||Standard Deviation|Mean
20073|NCT01773291|Primary|Glasgow Coma Scale (GCS)|"Eye response (E)~There are four grades starting with the most severe:~No eye opening~Eye opening in response to pain stimulus.~Eye opening to speech.~Eyes opening spontaneously Verbal response (V)~There are five grades starting with the most severe:~No verbal response~Incomprehensible sounds.~Inappropriate words.~Confused.~Oriented. Motor response (M)~There are six grades:~No motor response~Decerebrate posturing accentuated by pain~Decorticate posturing accentuated by pain~Withdrawal from pain~Localizes to pain~Obeys commands~The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The GCS was measured before and after treatment during hospitalization.||units on a scale||Standard Deviation|Mean
20074|NCT01773226|Secondary|Physical Function Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.||Scores on a WOMAC functionality scale||Standard Deviation|Mean
20075|NCT01773226|Secondary|Stiffness Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.||Scores on a WOMAC stiffness scale||Standard Deviation|Mean
20076|NCT01773226|Secondary|Pain Score|The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.||Scores on a WOMAC pain scale||Standard Deviation|Mean
20077|NCT01773226|Secondary|Number of Patients Using Rescue Medication|Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.|Up to 6 months post-injection|The incidence of patients using rescue medication for OA pain.||Frequency of Patients using Rescue medic|||Number
20078|NCT01773226|Primary|Number of Adverse Events|Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.|Up to 6 months post-injection|In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis.||Adverse Events (AEs)|||Number
20079|NCT01772654|Primary|Intensity of the MRI Signal in the Left Temporal Precentral Zone|Subjects who were already scheduled to have a Magnetic Resonance Imaging (MRI) procedure as part of an evaluation for epilepsy had an additional sequence added during the MRI. The additional MRI sequence was called Arterial Spin Labeling (ASL), and consisted of 4 minutes additional time in the MRI scanner. The ASL sequence did not use any contrast or radiation. The ASL sequence is a blood flow measure, and compared the intensity of the MRI signal in patients with left temporal lobe epilepsy to the intensity of the MRI signal in patients with normal brains. Intensity of MRI signal is measured on the MRI image slices in different anatomic regions as an optical density (dark to bright). It is then referenced to a region of the brain that is considered stable standard as a ratio.|Approximately in the middle of the MRI procedure|||ratio||Standard Deviation|Mean
20080|NCT01772550|Secondary|Catheter Integrity Failure|"Catheter integrity failure generally refers to any portion of the device breaking or malfunctioning so that its proper function is no longer assured. In this study, the most relevant catheter integrity failures to be assessed were fluid leakage, tubing rupture, or tubing separation from the hub.~The number of subjects who experienced injections with a catheter integrity failure during injection is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection."|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
20081|NCT01772550|Secondary|Catheter Transfixation|The number of subjects who experienced catheter transfixation (the IV penetrating the opposite wall of the vein) is reported. This information was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
20082|NCT01772550|Secondary|Catheter Dislodgement|The number of subjects who experienced partial or complete dislodgement of the catheter from the subject prior to power injection procedure completion is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|Immediately following power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
20123|NCT01770860|Secondary|Subjective Assessment of Pain|Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||percentage of pain||Standard Deviation|Mean
20083|NCT01772550|Secondary|High Pressure Alarm|The number of subjects who experienced injections with activation of the high pressure alarm is reported. Immediately following the power injection, the clinician performing the power injection recorded whether or not the high pressure alarm sounded.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
20084|NCT01772550|Secondary|Automatic Injection Shutoff|The number of subjects who experienced injections with automatic injection shutoff is reported. Immediately after the power injection, the injection technician recorded whether or not an automatic injection shutoff occurred.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
20085|NCT01772550|Secondary|Extravasation of Contrast Media|The number of subjects who experienced injections with extravasation of contrast media is reported.|upon contrast injection|One subject randomized to the 18 GA IV was excluded from the per-protocol analysis as minimum flow rate could not be achieved. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.||participants|||Number
20086|NCT01772550|Secondary|Catheter Insertion Success|"Insertion is successful when the catheter can be flushed or infused to demonstrate patency, and there is no inadvertent administration of a solution or medication into the tissue surrounding the IV catheter.~The number of participants with successfully inserted catheters after the first or second insertion attempt is reported. The clinician inserting the IV catheter made a clinical judgement as to whether the catheter was successfully placed; the protocol did not define more specific criteria. Catheter insertion success rates were determined from each IV insertion attempted in the Study."|immediately after catheter insertion|All subjects for whom an insertion was attempted are included in the analysis for insertion success. This includes some subjects that did not go on to complete the study.||participants|||Number
20087|NCT01772550|Secondary|Maximum Flow Rate|Maximum flow rate guidelines provided in the BD Nexiva Diffusics Instructions for Use were to be followed. The maximum flow rate (milliliters per second, or mL/sec) utilized was recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media. Results are descriptively summarized; no formal acceptance criteria were specified by the protocol.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized flow rate analysis only includes subjects who completed successful contrast delivery; one subject with extravasation upon delivery was discontinued and is not included.||mL/second||Standard Deviation|Mean
20088|NCT01772550|Secondary|Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|54 subjects had HU measurements available from complete chest and abdomen CT imaging.||Hounsfield Units||Standard Deviation|Mean
20089|NCT01772550|Secondary|Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|20 subjects had HU measurements available from thoracic CT imaging.||Hounsfield Units||Standard Deviation|Mean
20090|NCT01772550|Secondary|Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|126 subjects had HU measurements available from abdominal CT imaging.||Hounsfield Units||Standard Deviation|Mean
20091|NCT01772550|Primary|Acceptable Image Quality|"Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by:~The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and,~the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type.~In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority."|at the time of image assessment|One subject randomized to the 18 GA conventional catheter was excluded from the per-protocol analysis. Due to catheter placement, the required minimum flow rate of 5 mL/sec could not be achieved; contrast was administered at 4.5 mL/sec.||percentage of participants|||Number
41626|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban After Three Days of 5 mg IV Daily in HRS Type 1 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
20092|NCT01772316|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Minimum score was 0, maximum score was 3. A smaller score indicated improvement.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Standard Deviation|Mean
20093|NCT01772316|Secondary|Patient Pain VAS Score at Specified Time Points|This assessment represents the patient’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as “no pain” and the extreme right end as “unbearable pain”. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Standard Deviation|Mean
20094|NCT01772316|Secondary|Patient Global Visual Analog Score (VAS) at Specified Time Points|This assessment represents the patient’s overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS. The extreme left end of the line should be described as “no disease activity” (symptom free and no arthritis symptoms) and the extreme right end as “maximum disease activity” (maximum arthritis disease activity). Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Standard Deviation|Mean
20095|NCT01772316|Secondary|Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation||Randomization of first participant to clinical cutoff date (19MAY2015) (approximately 29 months)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||percentage of participants|||Number
20096|NCT01772316|Secondary|Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96||Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||percentage of participants|||Number
20097|NCT01772316|Primary|Change From Baseline in SJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. Change in SJC = SJC at Week 96 - SJC at Baseline. A negative number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||units on a scale||Standard Deviation|Mean
20098|NCT01772316|Primary|Change From Baseline in Swollen Joint Count (SJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A negative number indicated improvement.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||units on a scale||Standard Deviation|Mean
20099|NCT01772316|Primary|Change From Baseline in Total TJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
20100|NCT01772316|Primary|Change From Baseline in Total Tender Joint Count (TJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement. Here, 'n' represents the number of participants with a measure at specified time point.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
20101|NCT01772316|Primary|Change From Baseline in SDAI at Week 96|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, PGA and IGA, and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 96 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
20102|NCT01772316|Primary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, Patient Global Assessment of Disease Activity (PGA) and Investigator Global Assessment of Disease Activity (IGA), and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 48 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. Here, n signifies the number of subjects evaluable at the specified time points.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
20103|NCT01772316|Primary|Change From Baseline in DAS28-ESR at Week 96|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included SJC, TJC, acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status. For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC28]) + (0.28 × √[SJC28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 96 - DAS28-ESR at Baseline.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
20104|NCT01772316|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included swollen joint count (SJC), tender joint count (TJC), acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status (GH). For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC 28]) + (0.28 × √[SJC 28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 48 - DAS28-ESR at Baseline.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
20105|NCT01772316|Primary|Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response||Baseline up to follow-up (Week 104)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.||percentage of participants|||Number
20106|NCT01772316|Primary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a clinical investigation participant that was administered study drug, regardless of causal attribution.|Baseline up to follow-up (Week 104)|All participants receiving study drug were included in the safety analysis set.||percentage of participants|||Number
20107|NCT01772147|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.||puffs||Standard Error|Least Squares Mean
20108|NCT01772147|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.||Percentage of days||Standard Deviation|Mean
20109|NCT01772147|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 6-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
20110|NCT01772147|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
20124|NCT01770860|Secondary|Maceration|Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||percentage of maceration||Standard Deviation|Mean
20136|NCT01770743|Primary|Incidence of Adverse Events|Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84|From the time of the first immunization on Day 0 through Day 84|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
20111|NCT01772134|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.||puffs||Standard Error|Least Squares Mean
20112|NCT01772134|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.||Percentage of days||Standard Deviation|Mean
20113|NCT01772134|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 24-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
20114|NCT01772134|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
20115|NCT01771991|Secondary|Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients|Metrics are measured via analysis of pain and range of motion and Health Related Quality of Life questionnaire.|3 months||||||
20116|NCT01771991|Primary|Improvement in Neck Fibrosis|Improvement in fibrosis as defined as a one point improvement on the fibrosis scale.|3 months|||participants|||Number
20117|NCT01771913|Other Pre-specified|Number of Participants Experiencing Fat Necrosis in the Postoperative Period|Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance. It can emerge as oil cysts or small nodules a little bit painful. In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance. In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence.|up to 3 years|||participants|||Number
20118|NCT01771913|Secondary|Immunophenotyping|Immunophenotyping of the fresh stromal vascular fraction of both groups. Immunophenotyping or flow cytometry measures how many cells, in a sample, express a specific surface marker. A surface marker or a group of markers may characterize a specific cell type. The software that accompanies the flow cytometer determines the number of cells (in percentage) that express the tested surface marker.|baseline|we had technical problems in processing 4 tissue samples in each arm.||percentage of expression for CD90||Standard Deviation|Mean
20119|NCT01771913|Primary|Volume Maintenance|Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software. Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence. Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume. The result, expressed in percentage, expresses graft volume persistence.|up to 1 year|||percentage of graft volume persistency||Standard Deviation|Mean
20120|NCT01771172|Primary|Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.||within the first day|||percentage of success|||Number
20121|NCT01770860|Secondary|Subjective Assessment of Wound Healing|Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||Participants|||Number
20122|NCT01770860|Secondary|Subjective Assessment of Itch|Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||percentage of itching||Standard Deviation|Mean
20179|NCT01769443|Secondary|Incidence of Serious Infections Requiring Intravenous Antimicrobial Therapy||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20125|NCT01770860|Secondary|Edema|Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||scores on a scale||Standard Deviation|Mean
20126|NCT01770860|Secondary|Erythema|Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||scores on a scale||Standard Deviation|Mean
20127|NCT01770860|Secondary|Forced Rank Score|The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.||scores on a scale||Standard Deviation|Mean
20128|NCT01770860|Primary|Time to Healing (Days)|Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. Forty six subjects were enrolled but one withdrew before randomization.||days||95% Confidence Interval|Median
20129|NCT01770743|Primary|Incidence of Immunologically Significant Adverse Events of Special Interest|Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
20130|NCT01770743|Primary|Incidence of Clinical Laborabory Abnormalities|"Incidence of clinical laboratory abnormalities throughout the study (up to Day 84).~Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality."|From the time of first immunization on Day 0 to Day 84|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
20131|NCT01770743|Primary|Incidence of Reactogenicity By Severity|"Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity.~Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool):~Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 – 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm.~For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity."|For 7 days following each vaccination on Days 0, 14, 28|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
20132|NCT01770743|Primary|Incidence of Serious Adverse Events|Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)||participants|||Number
20133|NCT01770743|Secondary|TNA Seroconversion Rate|Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84|Up to Day 84|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
20134|NCT01770743|Secondary|TNA Level at Day 28|Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold|Day 28|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
20135|NCT01770743|Secondary|TNA Level at Day 42|Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold|Day 42|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
41627|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban After Three Days of 5 mg IV Daily in HRS Type 1 Patients||3 days|||ng/mL||Standard Deviation|Mean
20137|NCT01770743|Primary|Toxin Neutralizing Antibody (TNA) Level at Day 63|Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold|Day 63|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).||percentage of participants||95% Confidence Interval|Mean
20138|NCT01770691|Primary|Mean Percentage of Pad Weight Gain (PWG) Change|"All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages.~The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula:~% Reduction = 1-(Device/Baseline )*100~Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period."|up to 8 hours of use|||Mean percentage of PWG change||Standard Deviation|Mean
20139|NCT01770652|Primary|Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Fe24 (fraction of dose excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.~Some of the Fe24 values were over 100% which could be explained by variability in urine collection (e.g. incomplete collection of urine into the container) and volume measurement, as well as analytical imprecision."|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter||% of dose excreted in urine from 0-24 hr||Standard Deviation|Mean
20140|NCT01770652|Primary|Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide|Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||mg||Standard Deviation|Mean
20141|NCT01770652|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Standard Deviation|Mean
20142|NCT01770652|Primary|AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg*h/mL||Standard Deviation|Mean
20143|NCT01770652|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||hour||Full Range|Median
20144|NCT01770652|Secondary|Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of Ferriprox.|From time of dosing until 72 hours post-dose|||participants|||Number
20145|NCT01770652|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.||μg/mL||Standard Deviation|Mean
20146|NCT01770509|Secondary|Time to Complete Closure||4 weeks|Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients|||||
20147|NCT01770509|Secondary|Incidence of Adverse Events|Number of adverse effects at 4 weeks|4 weeks|||number of adverse effects|||Number
20148|NCT01770509|Secondary|Incidence of Adverse Events at 4 Weeks|Number of patients with adverse effects at 4 weeks|4 weeks|||Number of patients with adverse events|||Number
20149|NCT01770509|Secondary|Alleviation of Pain|Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain|4 weeks|||units on a scale||Standard Deviation|Mean
20150|NCT01770509|Primary|Logarithm of Percentage of Baseline Ulcer Size|Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width|From start of treatment to 4 weeks|Analysis is based on measures from each ulcer, when some participants had more than one ulcer||Mean of log (percentage of baseline area|Ulcers|Standard Deviation|Mean
20151|NCT01770483|Secondary|Normalization of Alanine Transferase Test|Liver function test,showing resolution of the inflammation of liver parenchyma|48week|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."||participants|||Number
20152|NCT01770483|Primary|Sustained Viral Response,|Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.|48 WEEK|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."||participants|||Number
20153|NCT01770392|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
20154|NCT01770392|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
20155|NCT01770392|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
20156|NCT01770379|Secondary|Percentage of Participants Achieving ACR50|"ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).~The ACR50 response results at week 24 used non-responder imputation."|Week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment||Percentage of patients|||Number
20157|NCT01770379|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.||units on a scale||Standard Error|Least Squares Mean
20158|NCT01770379|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.||Units on a scale||Standard Error|Least Squares Mean
20159|NCT01770379|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|"ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).~The ACR20 response results at week 24 used non-responder imputation."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.||percentage of participants|||Number
20160|NCT01770366|Primary|BMI||3 months post surgery|||kg/m2||Standard Deviation|Mean
20161|NCT01770314|Secondary|Satisfaction With the Program|"We tested and analyzed participants' satisfaction with the program by asking the question: Overall, how satisfied were you with the lessons. They answered on a 4 point Likert scale: 1=Not at all satisfied, 2=Somewhat Satisfied, 3=Satisfied, 4 = Very satisfied. Higher values indicate higher satisfaction."|One-month followup assessment|We only analyzed satisfaction data for experimental participants who had indicated that they disposed of their unused opioid medications (n=17)||units on a scale||Standard Deviation|Mean
20180|NCT01769443|Secondary|Development of Angiographically Evident Cardiac Allograft Vasculopathy at 1 Year||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20181|NCT01769443|Secondary|Incidence of Administering Desensitization Therapy Beyond 90 Days After Randomization||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20182|NCT01769443|Secondary|Incidence of Acute Renal Failure Requiring Hemodialysis||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20183|NCT01769443|Secondary|Incidence of Cerebral Vascular Accident||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20162|NCT01770314|Primary|Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications|"Responses are measured on a 4-point Likert scale (1= Not at all confident and 4= Extremely confident). The total Score range:8=least confident, 32=most confident.~How confident do you feel in your ability to do each of the following activities, today?~I can recognize side effects that are related to my opioid medicine.~I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant.~Internal consistency of the items in the pilot measure will be assessed (Cronbach’s alpha).~Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest."|Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention|||units on a scale||Standard Error|Least Squares Mean
20163|NCT01770145|Secondary|Change From Baseline in Gastric Emptying Time|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic on 2 occasions to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period). Note, to do the second gastroparesis assessment, this sub-group of subjects had an extension for one extra day beyond the designated 7 day APOKYN treatment period (i.e., it will be 8 days) in order to keep the 7 day diary recording outpatient scope of work the same as the rest of the subjects in the study. The second inpatient period was also considered the end-of-study visit for this sub group.|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period)|||||
20164|NCT01770145|Primary|"Change From Baseline in Average Daily Time to on (TTO) by Subject Diary."|"Patients will record daily time to on or TTO following their regularly scheduled first L-Dopa dose in the baseline period for 7 consecutive days. Following initiation on Apokyn therapy, patients will inject Apokyn at their regularly scheduled L-Dopa time (L-Dopa dosing will be delayed by 40 minutes following Apokyn injection) and record time to on or TTO from the injection. Time to on for both periods will be recorded in a standardized subject diary. Daily TTO for the baseline period will be averaged for each subject and compared to the daily TTO for the same subject during the treatment period to assess APOKYN's effect on TTO."|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7|||minutes||Standard Deviation|Mean
20165|NCT01769586|Primary|Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)|Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. This scale ranges from 0 to 5, where 0 denotes general anesthesia, in which the patient has no response to painful stimuli, and 5 denotes a level of minimal sedation in which the patient is fully awake.|Approximately 10 minutes or less|||participants|||Number
20166|NCT01769508|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|||months||95% Confidence Interval|Median
20167|NCT01769508|Secondary|Time to Progression (TTP)|Time to progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|||months||95% Confidence Interval|Median
20168|NCT01769508|Secondary|Toxicity Profile for Treated Patients|Defined as the frequency of adverse events for patients who received at least one dose of study treatment, and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months|All treated patients||participants|||Number
20169|NCT01769508|Secondary|Progression Free Survival (PFS)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||months||95% Confidence Interval|Median
20170|NCT01769508|Primary|Safety and Optimal Dose of Regimen|An additional primary objective is to evaluate the safety and optimal dose of lapatinib when added to 5-FU, oxaliplatin and radiation therapy.|18 months|||mg QD Lapatinib|||Number
20171|NCT01769508|Primary|Pathologic Complete Response Rate (pCR Rate)|Defined as the absence of invasive tumor in esophagogastric and lymph node tissue removed at time of surgery, as judged by the local pathologist. An improvement in pCR rate from 30 percent (historical) to 50 percent is the primary efficacy endpoint.|18 months|All patients who underwent surgery||participants|||Number
20172|NCT01769443|Secondary|Incidence of Rejection Episodes Per Subject and Freedom From Rejection|"Rejection is defined as follows:~Biopsy proven acute rejection (BPAR) of any grade (cellular rejection per 2004 ISHLT [International Society of Heart and Lung Transplantation] grading scale),~BPAR (individual grades),~BPAR (Biopsy Proven Acute Rejection) > 2R~antibody mediated rejection (AMR),~Any treated rejection,~Rejection associated with hemodynamic compromise (HDC)."|24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20173|NCT01769443|Secondary|Incidence of Hospitalizations||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20174|NCT01769443|Secondary|Re-transplantation or Re-listed for Transplantation||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20175|NCT01769443|Secondary|Death||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20176|NCT01769443|Secondary|Incidence of Post-Transplant Lymphoproliferative Disorder (PTLD)||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20177|NCT01769443|Secondary|Cardiac Dysfunction as Reflected in the Left Ventricular Ejection Fractions < 40% by Echocardiography, Angiogram or Nuclear Testing.||24 and 52 weeks:|No analyses were performed due to slow enrollment and early study closure.|||||
20178|NCT01769443|Secondary|Number of Subjects on Left Ventricular Assist Devices (LVAD) Compared to Those Not on LVADs||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.|||||
20188|NCT01769443|Secondary|Change in Calculated PRA (cPRA) From Wait Listing to Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20189|NCT01769443|Secondary|Time From Wait Listing to Heart Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20190|NCT01769443|Primary|Composite of Incidence of the Following Events in Subjects|"Death,~Removal from the transplant waiting list for any reason except improvement of cardiac function,~Initiation of any mechanical circulatory support device,~Severe infection requiring intravenous antibiotics,~Cerebral vascular accident,~Acute renal failure requiring dialysis."|At transplant, or 90 days post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.|||||
20191|NCT01769391|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (all timepoints pre-infusion)|All participants who received at least one dose of study drug and had evaluable PK data.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
20192|NCT01769391|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent improvement from baseline in the sum of target lesions.|Baseline to Progressive Disease or Death (Up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.||percent change in tumor size||Standard Deviation|Mean
20193|NCT01769391|Secondary|Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).|Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.||percentage of participants||95% Confidence Interval|Number
20194|NCT01769391|Secondary|Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of randomization to the date of first observation of objective progressive disease (PD)or death from any cause. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Randomization to Progressive Disease or Death (Up to 24 Months)|All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively.||months||95% Confidence Interval|Median
20195|NCT01769391|Secondary|Percentage of Participants With Anti Necitumumab Antibodies||Baseline to End of Cycle 6|All participants who received any amount of necitumumab and had post baseline antibody data.||percentage of participants|||Number
20196|NCT01769391|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab||Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (all timepoints post-infusion)|All participants who received at least one dose of necitumumab and had evaluable PK data.||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
20197|NCT01769391|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).|Randomization to Date of Death (Up to 24 Months)|All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively.||months||95% Confidence Interval|Median
20198|NCT01769391|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])|The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|Baseline to Disease Progression or Death (Up to 24 Months)|All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.||percentage of participants||95% Confidence Interval|Number
20199|NCT01769378|Secondary|Change From Baseline in Amylase|A summary of changes in amylase evaluation from baseline to endpoint.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable amylase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||Units/Liter||Inter-Quartile Range|Median
20200|NCT01769378|Secondary|Change From Baseline in Lipase|A summary of changes in lipase evaluation from baseline to endpoint.|Baseline, 24 Weeks|All participants who received at least one dose of study drug and had evaluable lipase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||Units/Liter||Inter-Quartile Range|Median
20201|NCT01769378|Secondary|Dulaglutide Anti-Drug Antibodies (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline up to 4 Weeks Post-Last Dose of Study Drug|ITT population: all randomized participants who received at least one dose of study drug.||participants|||Number
20263|NCT01768286|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set||percentage of participants|||Number
20202|NCT01769378|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 24 Weeks|ITT population: All randomized participants who received at least one dose of study drug.||weeks||Standard Error|Mean
20203|NCT01769378|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 24 Weeks|ITT population: all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
20204|NCT01769378|Secondary|Rate of HE Adjusted Per 30 Days|The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 24 weeks|ITT population: all randomized participants who received at least one dose of study drug.||number of events/participants/30 days||Standard Deviation|Mean
20205|NCT01769378|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.|Baseline through 24 Weeks|ITT Population: all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
20206|NCT01769378|Secondary|Change From Baseline in Calcitonin at 24 Weeks||Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline.||picogram per milliliter (pg/ml)||Inter-Quartile Range|Median
20207|NCT01769378|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: all randomized participants who received at least one dose of study drug.||participants|||Number
20208|NCT01769378|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: All randomized participants who received at least one dose of study drug.||participants|||Number
20209|NCT01769378|Secondary|Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks|LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline.||mg/dL||Standard Error|Least Squares Mean
20210|NCT01769378|Secondary|Change From Baseline in Body Mass Index (BMI) at 24 Weeks|LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline.||kilograms per/square meter kg/m^2||Standard Error|Least Squares Mean
20211|NCT01769378|Secondary|Change From Baseline in Body Weight at 24 Weeks|LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline.||kilograms (kg)||Standard Error|Least Squares Mean
20212|NCT01769378|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks|LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
20213|NCT01769378|Secondary|Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks|The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.|24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data.||percentage of participants|||Number
20214|NCT01769378|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks|Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline.||percent change of HbA1c||Standard Error|Least Squares Mean
20215|NCT01769365|Primary|Eradication|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy|||participants|||Number
20216|NCT01769339|Secondary|Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score|Pruritus is assessed by using a 100 millimeter (mm) of VAS score ranges from 0 to 100 mm, where 0 mm=no pruritus and 100 mm=worse pruritus.|1-hour after initial application|Data was not collected as only few participants had pruritus after 1-hour of study drug application.|||||
20217|NCT01769339|Secondary|Modified Itch Severity Scale (MISS) Score|The MISS is a specific instrument for assessing and quantifying the intensity of pruritus. The MISS score ranges from 0 to 21, where 0=no itching and 21=very severe itching.|Baseline and Day 28|Analysis Population included all the participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants who were evaluable at specified time-point.||units on a scale||Standard Deviation|Mean
20218|NCT01769339|Secondary|Percentage of Participants Who Achieved Clinical Cure|Participants were considered as clinically cured if the potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) test was negative for infection.|Baseline up to Day 28|Analysis population included all the participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
20219|NCT01769339|Primary|Mean Time to Itch Relief|Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.|1-hour after initial application|Analysis population included all the participants who received at least 1 dose of study medication.||minutes||Standard Error|Mean
20220|NCT01769248|Secondary|Percentage of Patients in Whom a Diagnosis is Acheived After Crossover (%)|As above. Crossover to FNA or FNB occurs after 3 passes without adequate material|1 yr||03/2015||||
20221|NCT01769248|Secondary|Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB|The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB|1 year||||||
20222|NCT01769248|Primary|Diagnostic Yield of EUS-FNB|The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.|1 year|||percentage of patients|||Number
20223|NCT01769105|Secondary|Change in Expressible Meibomian Glands|expressible Meibomian glands are measured with the Meibomian gland evaluator; A higher number of expressible Meibomian glands indicate a lower likelihood Meibomian Gland dysfunction.|after 3 month compared to baseline value|||number of expressible glands||Standard Deviation|Mean
20224|NCT01769105|Secondary|Change in Lipid Layer Thickness|"lipid layer thickness (LLT) is measured with the Lipiview-interferometer;~High values of LLT indicate a better lubrication of the ocular surface, so an increase in LLT can be regarded in an improvement of ocular surface.~LLT is measured in Interferometric color units (ICUs) whereas 1 ICU reflects about 1 nm lipid layer thickness."|after 3 month compared to baseline value|||nm||Standard Deviation|Mean
20225|NCT01769105|Secondary|Change in Tear Film Osmolarity|"osmolarity is measured with the tear-lab;~The osmolarity is measured in mOsm/l. A higher osmolarity can be regarded as an objective sign of dry eye disease.~A lower osmolarity after therapy can be regarded as an improvement of ocular surface disease."|after 3 month compared to baseline value|||mOsm/L||Standard Deviation|Mean
20226|NCT01769105|Secondary|Change of Break-up-time|"break-up-time is measured non-invasive with the Oculus Keratograph 5 M;~The break-up-time is measured in seconds. A low break-up-time suggests a lower lipid layer thickness. A higher break-up-time can be regarded as an improvement of ocular surface lubrication."|after 3 month compared to baseline value|||seconds||Standard Deviation|Mean
20227|NCT01769105|Primary|Change of Dry Eye Symptoms|"The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI)~Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness).~OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms."|after 3 month compared to baseline value|||units on a scale||Standard Deviation|Mean
20228|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26||baseline to week 26|completers population||percentage of participants|||Number
20229|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26||baseline to week 26|completers population||percentage of participants|||Number
20230|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26|Sperm motility was based upon the WHO grading scale: grade A, B, or C.|baseline to week 26|completers population||percentage of participants|||Number
20231|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26||baseline to week 26|completers population||percentage of participants|||Number
20232|NCT01768676|Primary|Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26|Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.|Baseline to Week 26|Completer population is defined as those who completed the study through week 26 and had semen analysis at both baseline and week 26. This may differ from the definition of completers for the study flow.||percentage of participants|||Number
20566|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20233|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.|Week 26|mITT population.Participants without post-baseline on-treatment values(HbA1c;body weight),no more than 30 days apart counted as non-responders if at least one of components(HbA1c;body weight) was available,showed non-response or experienced at least one symptomatic hypoglycemia during on-treatment period.Otherwise,they were counted as missing data.||percentage of participants|||Number
20234|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response. Otherwise, they were counted as missing data.||percentage of participants|||Number
20235|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 26|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.||percentage of participants|||Number
20236|NCT01768559|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)|"All randomized participants who were exposed to at least one dose of study drug, regardless of the amount of treatment administered.~The 4 participants in the TID group who received Insulin Glulisine QD were analyzed according to the QD dose.The 1 participant in the QD group who received Insulin Glulisine TID was analyzed according to the TID dose"||percentage of participants|||Number
20237|NCT01768559|Secondary|Total Insulin Dose at Week 26|"The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.~The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9."|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline total insulin dose assessment during on-treatment period.||U||Standard Deviation|Mean
20238|NCT01768559|Secondary|Insulin Glulisine Dose at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glulisine dose assessment during on-treatment period.||U||Standard Deviation|Mean
20239|NCT01768559|Secondary|Change in Insulin Glargine Dose From Baseline to Week 26|Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glargine dose assessment during on-treatment period.||U||Standard Error|Least Squares Mean
20240|NCT01768559|Secondary|Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Deviation|Mean
20241|NCT01768559|Secondary|Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Deviation|Mean
20242|NCT01768559|Secondary|Change in FPG From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
20243|NCT01768559|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 26|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
20244|NCT01768559|Secondary|Percentage of Participants With no Weight Gain at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
20245|NCT01768559|Secondary|Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26|The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
20246|NCT01768559|Primary|Change in Body Weight From Baseline to Week 26|"Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.~Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug."|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||kg||Standard Error|Least Squares Mean
20247|NCT01768559|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 26|modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.||percentage of hemoglobin||Standard Error|Least Squares Mean
20248|NCT01768325|Secondary|Number of Needle Passes||36 months|||Needle passes||Standard Deviation|Mean
20249|NCT01768325|Primary|Diagnostic Accuracy.||36 months|One patient was lost to follow up. Final diagnosis was unconfirmed.||Percentage of participants|||Number
20250|NCT01768325|Secondary|Overall Specimen Length||36 months|||mm||Standard Deviation|Mean
20251|NCT01768286|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-Treatment Virologic Failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
20252|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
20253|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
20254|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
20255|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
20256|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set with available data were analyzed. Participants in the LDV/SOF 12 Weeks and LDV/SOF+RBV 12 Weeks groups did not continue treatment past Week 12 and are not included in the analysis.||percentage of participants|||Number
20257|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
20258|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
20259|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Full Analysis Set||percentage of participants|||Number
20260|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set||percentage of participants|||Number
20261|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set||percentage of participants|||Number
20262|NCT01768286|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
20567|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20264|NCT01768286|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
20265|NCT01768117|Secondary|Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 month after vaccination 3|||participants|||Number
20266|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined||1 month after vaccination 3|||participants|||Number
20267|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ||1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3|||participants|||Number
20268|NCT01768117|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|||percentage of participants|||Number
20269|NCT01768117|Primary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||1 month after vaccination 3|||participants|||Number
20270|NCT01768013|Secondary|Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.|"Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28.~Investigator global assessment (IGA) is based on the investigator’s assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Day 28|||participants|||Number
20271|NCT01768013|Secondary|Efficacy: Percentage Change in m-PASI From Baseline to Day 28|"Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease.~The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified."|Baseline to Day 28|||percentage of change||Standard Deviation|Mean
20272|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
20273|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
20274|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
20275|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 14|||pg/mL||Standard Deviation|Mean
20276|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 7|||pg/mL||Standard Deviation|Mean
20277|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 1|||pg/mL||Standard Deviation|Mean
20278|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
20279|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
20280|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
20281|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 14|||pg/mL||Standard Deviation|Mean
20282|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 7|||pg/mL||Standard Deviation|Mean
20283|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 1|||pg/mL||Standard Deviation|Mean
20284|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
20285|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
20286|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
20287|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 14|||pg/mL||Standard Deviation|Mean
20288|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 7|||pg/mL||Standard Deviation|Mean
20289|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 1|||pg/mL||Standard Deviation|Mean
20290|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 14|||h*pg/mL||Standard Deviation|Mean
20291|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 7|||h*pg/mL||Standard Deviation|Mean
20292|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 1|||h*pg/mL||Standard Deviation|Mean
20293|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 14|||pg/mL||Standard Deviation|Mean
20294|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 7|||pg/mL||Standard Deviation|Mean
20295|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.|Day 1|||pg/mL||Standard Deviation|Mean
20296|NCT01768000|Secondary|Involvement Evaluation Questionnaire (IES)|The 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
20297|NCT01768000|Secondary|Satisfaction With Life Scale|8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
20298|NCT01768000|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
20299|NCT01768000|Primary|Multnomah Community Ability Scale (MCAS)|The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.|4 months following baseline assessment|||units on a scale||Standard Deviation|Mean
20300|NCT01767987|Secondary|Successful PCI|For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI.|At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
20301|NCT01767987|Secondary|Death, MI, Revascularization, CHF||1-4 weeks post PCI|||participants|||Number
20302|NCT01767987|Secondary|Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest||At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
20303|NCT01767987|Secondary|Left Ventricular End Diastolic Pressure (LVEDP)||During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.||mmHG|||Number
20304|NCT01767987|Secondary|Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI||Following completion of PCI through hospital discharge|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
20305|NCT01767987|Secondary|Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab|Abnormal heart activity|During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.||participants|||Number
20321|NCT01767519|Secondary|Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1|The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Micturition Episodes||Standard Deviation|Mean
20322|NCT01767519|Secondary|Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1|A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing ‘greatly improved’ or ‘improved.’|Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Percentage of Patients||95% Confidence Interval|Number
20306|NCT01767987|Secondary|TIMI Flow Rate (Grade)|"This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.* TIMI Grade [Description] TIMI 0 - no perfusion [no antegrade flow beyond the point of occlusion] TIMI 1 - penetration without perfusion [faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed] TIMI 2 - partial perfusion [delayed or sluggish antegrade flow with complete filling of the distal territory] TIMI 3 - complete perfusion [normal flow with complete filling of the distal territory]~*(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade."|TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.||units on a scale|||Number
20307|NCT01767987|Primary|CK-MB|CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|For the single subject completing the PCI intervention, CK-MB was not done because the CK level was below the threshold running the CK-MB test.|||||
20308|NCT01767987|Primary|Troponin|Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|Of the 4 Ranolazine Group subjects, 1 was withdrawn for pre-procedure study drug non-compliance; 3 had no PCI intervention. Of the 2 Placebo Group subject, 1 had no PCI intervention. The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject undergoing this protocol required test.||NG/ML|||Number
20309|NCT01767688|Secondary|Number of Participants Discontinued From Study Due to AEs|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.||Participants|||Number
20310|NCT01767688|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.||Participants|||Number
20311|NCT01767688|Secondary|Apparent Terminal Phase Half-life (t½)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||hr||Geometric Coefficient of Variation|Geometric Mean
20312|NCT01767688|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||hr||Full Range|Median
20313|NCT01767688|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||nM||95% Confidence Interval|Geometric Mean
20314|NCT01767688|Secondary|Plasma Concentration at 168 Hours After Dosing (C168h)||168 hours post-dose|All participants that received omarigliptin 25 mg.||nM||95% Confidence Interval|Geometric Mean
20315|NCT01767688|Secondary|Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||µM*hr||95% Confidence Interval|Geometric Mean
20316|NCT01767688|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.||µM*hr||95% Confidence Interval|Geometric Mean
20317|NCT01767597|Primary|Percentage of Patients Appropriately Seeking Care|"Subjects who are considered required to seek further care are as follows:~those who need HBV vaccination (non-immunized)~those who are infected with hepatitis B virus (infected)~Of these patients, subjects who have achieved appropriate care are considered as follows:~non immunized subjects who have initiated HBV vaccination sequence (vaccinated)~infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)~The percentage of patients appropriately seeking care will be then calculated by the following formula:~((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100"|6 months|Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).||percentage of participants|||Number
20318|NCT01767519|Secondary|Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Scores on a Scale||Standard Deviation|Mean
20319|NCT01767519|Secondary|Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Scores on a Scale||Standard Deviation|Mean
20320|NCT01767519|Secondary|Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1|Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Nocturia Episodes||Standard Deviation|Mean
20568|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full anlaysis set||percent change||Standard Error|Least Squares Mean
20323|NCT01767519|Primary|Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Percentage of Patients|||Number
20324|NCT01767519|Primary|Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized||Incontinence Episodes||Standard Deviation|Mean
20325|NCT01767285|Other Pre-specified|Patient Satisfaction|To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|Participants who completed the 12 month patient satisfaction assessment.||participants|||Number
20326|NCT01767285|Other Pre-specified|Pregnancy Rate|To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|||participants|||Number
20327|NCT01767285|Other Pre-specified|Continuation of Breastfeeding|To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|6 months|Participants who completed the 6 month assessment.||participants|||Number
20328|NCT01767285|Secondary|Continuation Rate|To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|6 months|Participants who completed the 6 month assessment.||participants|||Number
20329|NCT01767285|Secondary|Rate of Intercourse|To identify differences in the rates of intercourse prior to the 6-week postpartum visit.|6 weeks|Participants who completed the 6 week assessment.||participants|||Number
20330|NCT01767285|Primary|Continuation Rate|To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|1 year|Participants who completed the 1 year phone visit were included in analysis.||participants|||Number
20331|NCT01767116|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.||percentage of participants|||Number
20332|NCT01767116|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).||percentage of participants|||Number
20333|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of particpants|||Number
20334|NCT01767116|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.||percentage of participants|||Number
20335|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
20346|NCT01766921|Secondary|Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
20336|NCT01767116|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN)."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
20337|NCT01767103|Primary|Fe% for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative fraction of Ferriprox dose excreted in urine as deferiprone or deferiprone 3-O-glucuronide. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.~Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject’s data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.||percentage of dose excreted in urine||Standard Deviation|Mean
20338|NCT01767103|Primary|CumAe for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative amount of deferiprone and deferiprone 3-O-glucuronide excreted in the urine. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.~Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject’s data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.||mg||Standard Deviation|Mean
20339|NCT01767103|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||hour||Standard Deviation|Mean
20340|NCT01767103|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC (area under the curve) from zero to infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||ug*hr/mL||Standard Deviation|Mean
20341|NCT01767103|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||hour||Full Range|Median
20342|NCT01767103|Secondary|Safety and Tolerability of Ferriprox in Subjects With or Without Hepatic Impairment.|The number of participants who experienced adverse events following a single dose of Ferriprox, between the time of dosing and the follow-up visit (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests).|Time of dosing until 48 hours post-dose|The Safety Analysis Set consisted of all subjects who received study medication and had at least one safety assessment||participants|||Number
20343|NCT01767103|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter||ug/mL||Standard Deviation|Mean
20344|NCT01766921|Secondary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%."|Day 22, day 43 and day 387|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
20345|NCT01766921|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion.~The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
20423|NCT01766024|Primary|AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein|Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.|0 to 168 hours post-dose|||(ng/ml)*h||Inter-Quartile Range|Median
41628|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban After Three Days of 5 mg IV Daily in HRS Type 1 Patients||3 days|||hr||Standard Deviation|Mean
20347|NCT01766921|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine|Day 1 through day 387 after any vaccination|Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data.||Number of subjects|||Number
20348|NCT01766921|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data..||Number of subjects|||Number
20349|NCT01766921|Primary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.~Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
20350|NCT01766921|Primary|The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%."|Baseline (day 1) and Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
20351|NCT01766713|Primary|Change in Liver Fat as Measured by MRI-PDFF||24 weeks|compared to baseline, end of treatment MRI-PDFF||percentage of total fat||Standard Deviation|Mean
20352|NCT01766466|Primary|Extent of Aggregation Response During Ticagrelor Treatment|"Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.~A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.~Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion|||percentage of platelet reactivity (PR)||Standard Deviation|Mean
20353|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor|"A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.~Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion|||percentage of platelet reactivity (PR)||Standard Deviation|Mean
20354|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)|A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)|||percentage of platelet reactivity (PR)||Standard Deviation|Mean
20355|NCT01766336|Primary|Number of Participants Experiencing Treatment Emergent Adverse Events|To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.|36 weeks|||participants|||Number
20356|NCT01766310|Other Pre-specified|Prevalence of Hyperhomocysteinemia|prevalence of hyperhomocysteinemia in Thai obese children|8 weeks|||participants|||Number
20357|NCT01766310|Secondary|Serum Vitamin B12 Level|correlation between serum vitamin B12 and plasma homocysteine level|8 weeks||||||
20358|NCT01766310|Secondary|Serum Folate Level|correlation between serum folate and plasma homocysteine level|8 weeks||||||
20359|NCT01766310|Primary|Changes of Homocysteine Level|Mean difference of changes of homocysteine level between 2 treatment groups|8 weeks|||µmol/L||Standard Deviation|Mean
20360|NCT01766076|Primary|Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily|Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated|12 weeks|There was no cross-over or carry-over effect (the sequence did not matter), so we present data for 30 patients for their 12 weeks exposure to atorvastatin||percentage change in activated T-cells||Inter-Quartile Range|Median
20361|NCT01766050|Secondary|Mean Change From Baseline in Heart Rate at Study Discharge (Day 46±2 Days)|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and was measured in beats per minute (bpm). Hear rate was taken on Day 46 (day of discharge) during the follow up period. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who received study drug during the treatment period and had measurements at baseline and discharge.||bpm||Standard Deviation|Mean
20362|NCT01766050|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Study Discharge (Day 46±2 Days)|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Systolic and Diastolic blood pressures were taken on Day 46 (day of discharge from the study). Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who had received study drug during the treatment period and had measurements at baseline and at discharge.||mm Hg||Standard Deviation|Mean
20363|NCT01766050|Secondary|Mean Change From Baseline in Sitting Heart Rate - All Treated Participants|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and the heart rate was measured in beats per minute (bpm). Heart Rates were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received study medication and had baseline and specific day measurement.||bpm||Standard Deviation|Mean
20364|NCT01766050|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Pressures were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received any study medication and had a baseline and specific day blood pressure measurement available.||mm Hg||Standard Deviation|Mean
20365|NCT01766050|Secondary|Number of Participants With Out-of-Range Electrocardiogram Intervals - All Treated Participants|Participants had 12-Lead electrocardiograms (ECGs) performed at Screening Visit, Day 1 prior to dosing, Day 46 ±2, and at early termination. Definition of out-of-range: PR Interval >210 milliseconds (msec); QRS > 120 msec, QT > 500 msec or > 30 msec change from baseline (Day 1); QT with Fridericia correction (QTcF) > 450 msec or change from baseline of > 30 msec to <= 60 msec or change from baseline > 60 msec.|Day 1 to Day 46 ±2 days or at early termination|All participants who received any study medication and had an ECG performed on Day 1, Day 46 or early termination.||participants|||Number
20366|NCT01766050|Secondary|Number of Participants With Marked Hematology and Urinalysis Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46 ±2, and at early termination, after 10 hours fasting. Leukocytes: *10^9 cells per liter (c/L) < 0.85*Pre-Rx if Pre-Rx < LLN or <0.9*LLN if LLN <= Pre-Rx or Pre-Rx is missing. Neutrophils (absolute): *10^12 c/L < 0.85* Pre-Rx if Pre-Rx < 1.5, <1.5 if Pre-Rx >= 1.5, < 1.5 if Pre-Rx missing. Urine blood from dipstick: >=2 if Pre-Rx <1 or was missing or if Pre-Rx >=1. Urinary microscopic white blood cells (WBC) and red blood cells (RBC) >= 2 if Pre-Rx <2 or if Pre-Rx was missing or >=4 if Pre-Rx >=2.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.||participants|||Number
20367|NCT01766050|Secondary|Number of Participants With Marked Serum Chemistry Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46, and at early termination, after 10 hours fasting. Upper limits of normal (ULN); Lower limits of normal (LLN); Pre-therapy (Rx); micromoles per liter (µmol/L); millimoles per liter (mmol/L); grams per liter (g/L); Units per liter (U/L); Aspartate Aminotransferase (AST); Blood Urea Nitrogen (BUN) Total Bilirubin: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. AST: >1.25*Pre-Rx if Pre-Rx >ULN or 1.25*ULN if Pre-Rx <= ULN or Pre-Rx is missing. BUN: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. Phosphorus: <0.85*LLN if Pre-RX >= LLN or is missing or if Pre-Rx < LLN. total Protein: <0.9*LLN if Pre-Rx>= LLN or is missing or Pre-Rx > LLN. Creatine Kinase: >1.5*Pre-Rx if Pre-Rx > ULN or is missing or Pre-Rx is <= ULN. Lactate Dehydrogenase: >1.25*ULN if Pre-Rx <= ULN or missing, >1.5*Pre-Rx if Pre-Rx > ULN.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.||participants|||Number
20368|NCT01766050|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and AEs Leading to Discontinuation - All Treated Participants|Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA), version 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Events captured from Day 1 (pre-dose) to last day prior to discharge (Day 46 ±2). In the total group, a participant with an AE is only counted once (ie, data reflected in Days 1, 4, 7, and 11 below could be the same participant with an AE on multiple days of the study).|Day 1 to Day of discharge (Day 46±2)|All participants who received any study medication.||participants|||Number
20395|NCT01766050|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Tmax was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|||h||Full Range|Median
20369|NCT01766050|Secondary|Ratio of 1'-Hydroxy-Midazolam (Cmax) to Midazolam (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1'-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20370|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. AUC (0-T) and AUC (INF) were measured as ng*h/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
20371|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
20372|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity, were measured as ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
20373|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
20374|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): Area under the plasma concentration-time curve from time zero zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
20417|NCT01766024|Secondary|Tmax of Neopterin and MxA Protein|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose||||||
20418|NCT01766024|Secondary|Cmax of Neopterin and MxA Protein Blood Samples Were Taken Before the Injection, Then After 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 Hours.|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose||||||
20419|NCT01766024|Secondary|Cl of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
20569|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20375|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Cmax: Maximum observed plasma concentration was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
20376|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Losartan With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC (0-T): area under the concentration curve from time 0 to the time of the last quantifiable concentration and AUC (INF) extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
20377|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Losartan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
20378|NCT01766050|Primary|Adjusted Geometric Mean Area Under the Concentration Time Curve (AUC) From Zero to Last Concentration (0-T) and AUC Extrapolated to Infinity (INF) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration and AUC (INF): AUC from time zero extrapolated to infinite time were measured in ng*h/mL. Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Midazolam measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||90% Confidence Interval|Geometric Mean
20379|NCT01766050|Secondary|Ratio of 1’-Hydroxy-Midazolam AUC(0-T) to Midazolam AUC(0-T) and 1’-Hydroxy-Midazolam AUC(INF) to Midazolam AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1’-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20380|NCT01766050|Secondary|Ratio of 5-Dextrorphan (Cmax) to Dextromethorphan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan) to parent (dextromethorphan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20420|NCT01766024|Secondary|Кel of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
20570|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20381|NCT01766050|Secondary|Ratio of 5-Dextrorphan AUC(0-T) to Dextromethorphan AUC(0-T) and 5-Dextrorphan AUC(INF) to Dextromethorphan AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan ) to parent (dextromethorphan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20382|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole (Cmax) to Omeprazole (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20383|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole AUC(0-T) to Omeprazole AUC(0-T) and 5-Hydroxyomeprazole AUC(INF) to Omeprazole AUC(INF) , Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-Hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20384|NCT01766050|Secondary|Ratio of E-3174 (Cmax) to Losartan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20385|NCT01766050|Secondary|Ratio of E-3174 AUC(0-T) to Losartan AUC(0-T) and E3174 AUC (INF) to Losartan AUC (INF) Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20386|NCT01766050|Secondary|Ratio of Paraxanthine (Cmax) to Caffeine (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and their metabolites were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20387|NCT01766050|Secondary|Ratio of Paraxanthine AUC(0-T) to Caffeine AUC(0-T) and Paraxanthine AUC (INF) to Caffeine AUC (INF), Corrected for Molecular Weight [MR_AUC(0-T) and MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ratio||Geometric Coefficient of Variation|Geometric Mean
20421|NCT01766024|Secondary|Т½ of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
20388|NCT01766050|Secondary|T-HALF of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Plasma half-life (T-HALF) was measured in hours (h). Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||h||Standard Deviation|Mean
20389|NCT01766050|Secondary|Tmax of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Time of maximum observed plasma concentration (Tmax) was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||h||Full Range|Median
20390|NCT01766050|Secondary|AUC(INF) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
20391|NCT01766050|Secondary|AUC(0-T) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration [AUC(0-T)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
20392|NCT01766050|Secondary|Cmax of Inje Cocktail Metabolites (1’-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail component metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail component metabolites were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
20393|NCT01766050|Secondary|Apparent Total Body Clearance (CLT/F) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. CLT/F was measured as liters/hour (L/h)|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|||L/h||Geometric Coefficient of Variation|Geometric Mean
20394|NCT01766050|Secondary|Plasma Half-Life (T-HALF) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. T-HALF was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).||h||Standard Deviation|Mean
20422|NCT01766024|Secondary|Тmax of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose||||||
20396|NCT01766050|Primary|Adjusted Geometric Mean Maximum Drug Concentration (Cmax) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Cmax measured in nanograms per milliliter (ng/mL). Inje cocktail components (Midazolam) measured using High Performance Liquid Chromatography (HPLC) with Tandem Mass Spectrometry (MS/MS) Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Participants who received any study drug and had at least 1 adequate Pharmacokinetic (PK) profile for any Inje cocktail analytes (parent or metabolite).||ng/mL||90% Confidence Interval|Geometric Mean
20397|NCT01766037|Other Pre-specified|Safety Outcomes|The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent of Subjects|||Number
20398|NCT01766037|Secondary|Change in Number of Subjects on Diabetes Medication|Percent change in the number of subjects on Diabetes medication|52 weeks|Subjects being treated for Type II Diabetes||% Change in Subjects on Medication|||Number
20399|NCT01766037|Secondary|Change in Number of Subjects on Dyslipidemia Medications|Percent change in the number of subjects on Dyslipidemia medications|52 weeks|Subjects being treated for high cholesterol||% Change in Subjects on Medication|||Number
20400|NCT01766037|Secondary|Change in Number of Subjects on Hypertension Medication|Percent change in the number of subjects on Hypertension medication|52 weeks|Subjects being treated for hypertension||% Change in Subjects on Medication|||Number
20401|NCT01766037|Secondary|Change in Medications for Type 2 Diabetes|Percent change in the number of medications taken by subjects for Type 2 Diabetes|52 weeks|Subjects being treated for Type 2 Diabetes||Percent Change in Medications|||Number
20402|NCT01766037|Secondary|Change in Medications for Dyslipidemia|Percent change in the number of medications taken by subjects for dyslipidemia|52 weeks|Subjects being treated for high cholesterol||Percent Change in Medications|||Number
20403|NCT01766037|Secondary|Change in Medication for Hypertension|Percent change in the number of medications taken by subjects for hypertension|52 weeks|Subjects being treated with medications for hypertension||Percent Change in Medications|||Number
20404|NCT01766037|Secondary|Procedural Success|vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy|52 weeks|All A-Tube placement attempts||Percent Procedural Success|||Number
20405|NCT01766037|Secondary|Mean Change in Hemoglobin A1C|vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.|52 weeks|Subjects with Type 2 Diabetes||DCCT% change||95% Confidence Interval|Mean
20406|NCT01766037|Secondary|Mean Change in Score for IWQOL Questionnaire|"v) Impact of Weight on Quality of Life (IWQOL) questionnaire total score~Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients’ IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI’s between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points."|52 weeks|Subjects who completed the Questionnaire at 52 weeks||score on a scale||95% Confidence Interval|Mean
20407|NCT01766037|Secondary|Mean Percent Change in Blood Pressure|iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks||Percent Change||95% Confidence Interval|Mean
20408|NCT01766037|Secondary|Mean Percent Change in Serum Lipids|iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks||Percent Change||95% Confidence Interval|Mean
20409|NCT01766037|Secondary|Percent of Subjects With ≥10% Total Body Weight Loss|ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent of Subjects||95% Confidence Interval|Number
20410|NCT01766037|Secondary|Mean Percent Total Body Weight Loss|i) Mean percent absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent Total Weight Loss||Standard Deviation|Mean
20411|NCT01766037|Primary|% of Subjects Who Achieve >25% EWL|The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects||Percent of Subjects||95% Confidence Interval|Number
20412|NCT01766037|Primary|Mean Percent Excess Weight Loss (%EWL)|The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.|52 weeks|Modified Intent To Treat (mITT) population defined as all enrolled subjects||Percent Excess Weight Loss||Standard Deviation|Mean
20413|NCT01766024|Secondary|Study Withdrawal Rate Due to AE|Secondary outcome measure for safety assessment|up to Day 43||||||
20414|NCT01766024|Secondary|Local Reaction Incidence|Secondary outcome measure for tolerability assessment|up to Day 43||||||
20415|NCT01766024|Secondary|AE of Garde 3-4 Incidence|Secondary outcome measure for safety assessment|up to Day 43||||||
20416|NCT01766024|Secondary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Secondary outcome measure for safety assessment|up to Day 43||||||
20424|NCT01766024|Primary|Cmax of Interferon Beta-1a|Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose|||pg/ml||Inter-Quartile Range|Median
20425|NCT01766024|Primary|Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)|Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose|||(pg/ml)•h||Inter-Quartile Range|Median
20426|NCT01765972|Primary|Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit|Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.|8 hours post fit|Analysis population consists of subjects that completed all study visits without a major protocol deviation.||percentage of change from baseline||Standard Deviation|Mean
20427|NCT01765803|Secondary|Toxicity|"Toxicity will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.~Any subject who receives treatment on this protocol will be evaluable for toxicity."|Up to 1 month after treatment|||participants|||Number
20428|NCT01765803|Primary|CD34+ Progenitor Cell Mobilization|To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported|8 hours following treatment|||percentage of total WBC count||Standard Deviation|Mean
20429|NCT01765764|Secondary|Percentage of Participants With ‘Very Satisfied’ or ‘Mostly Satisfied’ in Eyebrow Satisfaction Scale (ESS) Item #6|"ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported."|Month 7|Intent-to-treat population included all randomized participants.||percentage of participants|||Number
20430|NCT01765764|Secondary|Change From Baseline in Eyebrow Darkness as Measured Using DMSIA|Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.||intensity units||Standard Deviation|Mean
20431|NCT01765764|Secondary|Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)|Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.||mm^2||Standard Deviation|Mean
20432|NCT01765764|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale|The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.|Baseline, Month 7|Intent-to-treat population included all randomized participants.||percentage of participants|||Number
20433|NCT01765569|Primary|Apparent Clearance (CL/F) of Digoxin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.||liters/hour||Standard Deviation|Mean
20434|NCT01765569|Primary|Terminal Half-Life (t1/2) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.||hours||Standard Deviation|Mean
20435|NCT01765569|Primary|Time to Maximum Plasma Concentration (Tmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||hours||Full Range|Median
20436|NCT01765569|Primary|Maximum Plasma Concentration (Cmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||ng/mL||Standard Deviation|Mean
20437|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC168) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||hour*ng/mL||Standard Deviation|Mean
20489|NCT01764607|Secondary|Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma|Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.|At baseline and time of surgical removal (5 weeks).|||percentage of baseline size|||Number
20438|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.||hour*ng/mL||Standard Deviation|Mean
20439|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.||hour*ng/mL||Standard Deviation|Mean
20440|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Digoxin|AUClast = Area under the plasma-concentration time curve from time zero to the last measurable plasma concentration which is presented in hour*nanogram per milliliter (hour*ng/mL). Hour 0 (H0) signified pre-dose sampling.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population included participants for whom PK data were collected.||hour*ng/mL||Standard Deviation|Mean
20441|NCT01765543|Other Pre-specified|Percent Extrapolated AUC(0-inf) (AUCpeo) of Vemurafenib|The AUCpeo, that is, percent area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUCpeo = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf). This parameter provides information about what percentage of the theoretical curve AUC(0-inf) is possible to determine experimentally (AUC0-last).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||percent AUC||Geometric Coefficient of Variation|Geometric Mean
20442|NCT01765543|Other Pre-specified|Area Under the Plasma Concentration Time-curve From Zero to 168 Hours [AUC(0-168)] of Vemurafenib|AUC(0-168) is the AUC from time zero (pre-dose) to 168 hours (time point for last blood sample collection). AUC is a measure of the plasma concentration of a drug over time. AUC(0-168) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
20443|NCT01765543|Other Pre-specified|Plasma Apparent Clearance (CL/F) of Vemurafenib|Clearance of a drug is a measure of the rate at which a drug is removed (metabolized or eliminated by normal biological processes) from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||liters/hour||Geometric Coefficient of Variation|Geometric Mean
20444|NCT01765543|Other Pre-specified|Plasma Elimination Half Life (t1/2) of Vemurafenib|Plasma elimination half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||hours||Standard Deviation|Mean
20445|NCT01765543|Other Pre-specified|Time to Reach Cmax (Tmax) of Vemurafenib|Tmax is the time from vemurafenib administration to reach Cmax for vemurafenib.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||hours||Full Range|Median
20446|NCT01765543|Primary|Maximum Observed Plasma Concentration (Cmax) of Vemurafenib|Cmax is the maximum observed plasma vemurafenib concentration, presented in microgram per milliliter (mcg/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
20447|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to Extrapolated Infinite Time (AUC[0-inf]) of Vemurafenib|AUC(0-inf) is the AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
20448|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measurable Concentration Time Point (AUClast) of Vemurafenib|AUClast is the area under the vemurafenib plasma concentration versus time curve from time zero to the time of last measured concentration of vemurafenib (Tlast). Area under the curve (AUC) is a measure of the plasma concentration of a drug over time. AUClast is presented in micrograms times (*) hour per milliliter (mcg*h/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|The pharmacokinetics (PK) parameter population included all participants who received both scheduled doses of vemurafenib and who provided adequate PK assessments to calculate important PK parameters.||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
20449|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(WBC Count)|"laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month|||cells (10^6/µl)||Standard Deviation|Mean
20450|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)|"laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month|||IU/dL||Standard Deviation|Mean
20451|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)|"laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month|||mg/dL||Standard Deviation|Mean
20490|NCT01764607|Primary|Measure of Squamous Cell Skin Carcinoma in Patients|Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.|Baseline, time of surgical removal (5 weeks) and 1 year.|||mm|||Number
20452|NCT01765465|Primary|the Number of the Participants Have Postoperative RUQ Pain|"Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month.~The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual.~The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results."|postoperative 3-month|||number of participants|||Number
20453|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related SAEs|A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.|Dose 1 until 28 days after Dose 2 (Up to Day 118)|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
20454|NCT01765426|Secondary|Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination|A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported.|Day 0 to Day 104|Full analysis set included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid sample for immunogenicity (eg, seroconversion) was received.||percentage of participants|||Number
20455|NCT01765426|Secondary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Days 90 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||percentage of participants||95% Confidence Interval|Number
20456|NCT01765426|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes||Days 0, 28, 90, 118 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||titer||95% Confidence Interval|Geometric Mean
20457|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 118|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||percentage of participants||95% Confidence Interval|Number
20458|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 28|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.||percentage of participants||95% Confidence Interval|Number
20459|NCT01765426|Primary|Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)|"The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs.~Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention."|118 Days|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
20460|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
20461|NCT01765426|Primary|Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
20476|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Peak Expiratory Flow (PEF)|PEF is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. PEF will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.||liters/minute (L/min)||Standard Error|Least Squares Mean
20462|NCT01765426|Primary|Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
20463|NCT01765426|Primary|Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant’s worst reported severity grade.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
20464|NCT01765426|Primary|Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.||percentage of participants|||Number
20465|NCT01765270|Secondary|Need for Antiarrhythmic Therapy||CABG surg to hospital discharge Approximately 5 days|||participants|||Number
20466|NCT01765270|Secondary|Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support||CABG to hospital discharge (Approximately 5 days)|||participants|||Number
20467|NCT01765270|Secondary|Number of Participants Who Had an Episode of Hypoglycemia||baseline to end of study (Approximately 35-37 days)|||participants|||Number
20468|NCT01765270|Secondary|Duration of Inotropic Support||CABG surg until hosp discharge (Approximately 5 days)|||hours||Standard Deviation|Mean
20469|NCT01765270|Secondary|Number of Major Adverse Cardiac Events (MACE)|Death, myocardial infarction (MI), or New congestive heart failure (CHF)|Baseline to end of study (Approximately 35-37 days)|||Cardiac Events|||Number
20470|NCT01765270|Secondary|Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|||ng*hr/mL||Inter-Quartile Range|Median
20471|NCT01765270|Secondary|High Sensitive Troponin-I (hsTnT) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|||ng*hr/mL||Inter-Quartile Range|Median
20472|NCT01765270|Primary|Troponin I (TnI) Area Under the Curve (AUC)||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)|||ng*hr/mL||Inter-Quartile Range|Median
20473|NCT01765192|Secondary|Change From Baseline in Nighttime Asthma Symptoms|Patients will assess their daily night-time asthma symptoms according to the following scale: 0: No symptoms, slept through the night. 1: Slept well but some complaints in the morning. 2: Woke up once because of asthma (inclusive early awakening). 3: Woke up several times because of asthma (inclusive early awakening). 4: Bad night, awake most of the night because of asthma. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.||units on a scale||Standard Error|Least Squares Mean
20474|NCT01765192|Secondary|Change From Baseline in Daytime Asthma Symptoms|Patients will assess their daily day-time asthma symptoms according to the following scale: 0: Very well, no symptoms. 1: One episode of wheezing, cough or breathlessness. 2: More than one episode of wheezing, cough or breathlessness without interfering with normal activities. 3: Wheezing, cough or short of breath most of the day which interfered to some extent with normal activities. 4: Asthma very bad. Unable to carry out daily activities as usual. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.||units on a scale||Standard Error|Least Squares Mean
20475|NCT01765192|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF will be measured at home using portable electronic peak flow meter. The participant will record PEF daily in the morning immediately after getting up. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.||L/min||Standard Error|Least Squares Mean
20477|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Flow (FEF) 25-75%|FEF is a measure of how much air can be exhaled from the lungs. It is an indicator of obstruction of the smaller airways. FEF25-75% is the mid-flow rate or forced expiratory flow occurring in the middle 50% of the patient's exhaled volume, and will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEF data available for analysis after 4 weeks of treatment.||liters/second||Standard Error|Least Squares Mean
20478|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FVC measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FVC data available for analysis after 4 weeks of treatment.||liters||Standard Error|Least Squares Mean
20479|NCT01765192|Primary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured using spirometry in accordance with the American Thoracic Society / European Respiratory Society (ATS/ERS) consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEV1 measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEV1 data available for analysis after 4 weeks of treatment.||liters||Standard Error|Least Squares Mean
20480|NCT01764945|Primary|AUC0-tz|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 to the time of the last quantifiable data point.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
20481|NCT01764945|Primary|Cmax|Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
20482|NCT01764945|Primary|AUC0-∞|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.|Pharmacokinetic analysis set (PK set) includes all subjects who provided evaluable data for at least 1 evaluable observation for a PK endpoint in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
20483|NCT01764919|Other Pre-specified|Explore the Performance of [124I]FIAU PET-CT Compared to MRI in Detecting Osteomyelitis by Chronic Kidney Disease (CKD) Stage (Stage 1+2, Stage 3, and Stage 4+5).||-2 hours to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.|||||
20484|NCT01764919|Secondary|Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI|Additional information on the extent and localization of infection will be compared to MRI.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.|||||
20485|NCT01764919|Secondary|Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection|All PET-CT images will be evaluated centrally and independently by a single radiologist. Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.|||||
20486|NCT01764919|Secondary|Assess the Safety and Tolerability of [124I]FIAU|Safety will be monitored for all subjects for the duration of their study participation. Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.|30 +/- 2 days|||participants with adverse events|||Number
20487|NCT01764919|Primary|Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection.|A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.|30 hours|||participants|||Number
20488|NCT01764685|Primary|Number of Heavy Drinking Days Per Week by Medication Group|Total number of heavy drinking days (>4 drinks for men; >3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication.|11-week study period|Data was only collected on 3 of the 4 subjects.||Number of heavy drinking days/week|||Number
20571|NCT01763905|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20491|NCT01764386|Secondary|Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26|Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
20492|NCT01764386|Secondary|Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26|Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
20493|NCT01764386|Secondary|Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26|The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
20494|NCT01764386|Secondary|Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26|HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose * Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||units on a scale||Standard Error|Least Squares Mean
20495|NCT01764386|Secondary|Change Fasting Insulin From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||uIU/mL||Standard Error|Least Squares Mean
20496|NCT01764386|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
20497|NCT01764386|Secondary|Change in Heart Rate From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||bpm||Standard Error|Least Squares Mean
20498|NCT01764386|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mm Hg||Standard Error|Least Squares Mean
20499|NCT01764386|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mm Hg||Standard Error|Least Squares Mean
20500|NCT01764386|Secondary|Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
20501|NCT01764386|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
20502|NCT01764386|Secondary|Change in Fasting Triglycerides From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||mg/dL||Standard Error|Least Squares Mean
20503|NCT01764386|Secondary|Change in Waist Circumference From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||cm||Standard Error|Least Squares Mean
20504|NCT01764386|Secondary|Absolute Change in Body Weight From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||kg||Standard Error|Least Squares Mean
20505|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percentage of participants|||Number
20506|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percentage of participants|||Number
20507|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percentage of participants|||Number
20508|NCT01764386|Primary|Percent Change in Body Weight From Baseline (Day 1) to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.||percent change in body weight||Standard Error|Least Squares Mean
20509|NCT01764022|Secondary|T1/2|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||hours||Inter-Quartile Range|Median
20510|NCT01764022|Secondary|Tmax|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||hours||Inter-Quartile Range|Median
20511|NCT01764022|Secondary|Cmax|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||µg/ml||Inter-Quartile Range|Median
20512|NCT01764022|Secondary|Occurrence of Anti-trastuzumab Antibodies|Secondary outcome measure for immunogenicity assessment|Day 1 (before the drug administration), Day 15, 64 and 127|Patients who received at least one injection of study drug.||participants|||Number
20513|NCT01764022|Secondary|Treatment Discontinuation Rate Due to AE|secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.||participants|||Number
20514|NCT01764022|Secondary|Number of Patients in Whom Chemotherapy Cycles Had Been Postponed Due to Adverse Events (AE)|secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.||participants|||Number
20515|NCT01764022|Secondary|Progression Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
20516|NCT01764022|Secondary|Stabilization Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
20517|NCT01764022|Secondary|Partial Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
20557|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20572|NCT01763905|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20518|NCT01764022|Secondary|Complete Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Mean
20519|NCT01764022|Primary|Area Under the Curve After the First Test Drug Administration|primary outcome measure for pharmacokinetics (PK) substudy|up to Day 22, after the first trastuzumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.||(µg/ml)*hour||Inter-Quartile Range|Median
20520|NCT01764022|Primary|Overall Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.||percentage of patients||95% Confidence Interval|Number
20521|NCT01763996|Secondary|Exercise Duration|Exercise duration is the exercise time in seconds during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||seconds||95% Confidence Interval|Least Squares Mean
20522|NCT01763996|Secondary|Time to Onset of Angina During Exercise Treadmill Test at the End of the Administration of Febuxostat and Placebo|Time in seconds to ischemic chest pain/ angina during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic chest pain.||seconds||Standard Deviation|Mean
20523|NCT01763996|Secondary|Percentage of Participants Stopping Exercise Treadmill Test Due to Angina at the End of the Administration of Febuxostat and Placebo|An exercise treadmill test (modified Bruce protocol) was performed. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||percentage of participants|||Number
20524|NCT01763996|Secondary|Change in Maximum ST-segment Depression During Exercise Treadmill Test|Continuous ECG was performed during an exercise treadmill test (modified Bruce protocol) to assess the maximum ST-segment depression after 6 weeks of febuxostat or placebo treatment in participants with a normal ST segment at randomization. A negative change from Baseline indicates improvement. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ST segment change.||mm||Standard Deviation|Mean
20525|NCT01763996|Secondary|Change in Time to Onset of ≥1 mm ST-Segment Depression During Exercise Treadmill Test (ETT)|Time in seconds to ischemic ECG changes during ETT. Continuous electrocardiography (ECG) was performed during an exercise treadmill test (modified Bruce protocol) to assess the onset of ST-segment depression after administration of febuxostat or placebo for 6 weeks in participants with a normal ST segment at randomization. . Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic ECG changes.||seconds||Standard Deviation|Mean
20526|NCT01763996|Secondary|Change in Coronary Flow Velocity Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.||cm/second||95% Confidence Interval|Least Squares Mean
20527|NCT01763996|Secondary|Change in Coronary Artery Cross Sectional Area Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery cross sectional area was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.||mm^2||95% Confidence Interval|Least Squares Mean
20528|NCT01763996|Secondary|Change in Coronary Artery Flow Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.||mL/min||95% Confidence Interval|Least Squares Mean
20558|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20529|NCT01763996|Secondary|Change in Coronary Flow Velocity From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||cm/second||95% Confidence Interval|Least Squares Mean
20530|NCT01763996|Secondary|Change in Coronary Artery Cross-Sectional Area From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery cross-sectional area was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||mm^2||95% Confidence Interval|Least Squares Mean
20531|NCT01763996|Primary|Change in Coronary Artery Flow From Rest to Isometric Handgrip (IHG) Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured using magnetic resonance imaging (MRI) at rest and during sustained isometric (static) handgrip exercises. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.||mL/min||95% Confidence Interval|Least Squares Mean
20532|NCT01763918|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20533|NCT01763918|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20534|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20535|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20536|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20537|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20538|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20539|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20540|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20541|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20542|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20543|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20544|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20545|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20546|NCT01763918|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20547|NCT01763918|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20548|NCT01763918|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20549|NCT01763918|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20550|NCT01763918|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
20551|NCT01763918|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
20552|NCT01763918|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20553|NCT01763918|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set. Least squares (LS) means are from a repeated measures linear effects model; missing values were not imputed.||percent change||Standard Error|Least Squares Mean
20554|NCT01763905|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set with available data (no imputation was performed).||percent change||Standard Error|Least Squares Mean
20555|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20556|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20575|NCT01763905|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set (all randomized participants who received at least 1 dose of investigational product (subcutaneously or orally)) with available data (no imputation was performed).||percent change||Standard Error|Least Squares Mean
20576|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20577|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20578|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20579|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20580|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20581|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20582|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20583|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20584|NCT01763866|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20585|NCT01763866|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20586|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20587|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20588|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20589|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20590|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20591|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20592|NCT01763866|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20593|NCT01763866|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20594|NCT01763866|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
20595|NCT01763866|Secondary|Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
20596|NCT01763866|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20597|NCT01763866|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20598|NCT01763827|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set||percent change||Inter-Quartile Range|Median
20599|NCT01763827|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
20600|NCT01763827|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Ful analysis set||percent change||Inter-Quartile Range|Median
20601|NCT01763827|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
20602|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set||percent change||Inter-Quartile Range|Median
20603|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
20604|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set||percent change||Inter-Quartile Range|Median
20605|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Inter-Quartile Range|Median
20606|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20607|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20608|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20609|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20613|NCT01763827|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20614|NCT01763827|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20615|NCT01763827|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set||percentage of participants||95% Confidence Interval|Number
20616|NCT01763827|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
20617|NCT01763827|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||mg/dL||Standard Error|Least Squares Mean
20618|NCT01763827|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20619|NCT01763827|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set||percent change||Standard Error|Least Squares Mean
20620|NCT01763645|Secondary|Occurrence of Anti-bevacizumab Antibodies|Secondary outcome measure for immunogenicity assessment|Day 1 (before the drug administration), Day 15, 64 and 127|||percentage of patients|||Number
20621|NCT01763645|Secondary|Progression Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
20622|NCT01763645|Secondary|Stabilization Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
20623|NCT01763645|Secondary|Partial Response Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
20624|NCT01763645|Secondary|Complete Response Rate|secondary outcome measure for efficacy evaluation|Day 127|||percentage of patients||95% Confidence Interval|Number
20625|NCT01763645|Primary|Area Under the Curve After the First Test Drug Administration|primary outcome measure for pharmacokinetics (PK) substudy|up to Day 22, after the first bevacizumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after injection had missed <= 1 blood sample collection to analyze pharmacokinetics.||(ng/ml)*hour||Inter-Quartile Range|Median
20626|NCT01763645|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Day 127|The efficacy analysis included only those patients who received at least one dose of BCD-021 or Avastin®, and in whom it was possible to assess the response to therapy.||percentage of participans||95% Confidence Interval|Number
20627|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert|Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours|||percentage of all alerts|||Number
20628|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert|Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours|||percentage of all alerts|||Number
20629|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|72 hours|||percentage of total events|||Number
20630|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|up to 72 hours|||percentage of total events|||Number
20631|NCT01763567|Primary|Device Performance: Accuracy of HGMS|"Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values].~The portable i-STAT handheld makes patient-side testing easy:~Requires no special sample preparation or user calibration; maintenance is minimal~Weighs 18 ounces, making it portable~Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:~The system prompts users step by step through the testing process~Operator and patient information can be entered via barcode scanner~Operator lockout prevents unauthorized users from performing or viewing test results~Test results are uploaded automatically when the i-STAT handheld is placed in a downloader"|up to 72 hours|To assess safety and device performance for the Hospital Glucose Managment system||percent difference||Standard Deviation|Mean
20632|NCT01763047|Primary|CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8-12 days post wear|The analysis consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.||units on a scale||Standard Deviation|Mean
20633|NCT01763047|Primary|Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher|Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.||Percentage of Subject Eyes|Participants||Number
20634|NCT01763047|Primary|Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher|The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.||Percentage of Subject Eyes|Participants||Number
20635|NCT01763047|Primary|Percentage of Eyes With Corneal Staining Grade 3 or Higher|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject’s inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.The analysis was conducted on subject eyes for each lens and strata.||Percentage of Subject Eyes|Participants||Number
20636|NCT01763047|Primary|Binocular Near Visual Acuity (logMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.||LogMAR||Standard Deviation|Mean
20637|NCT01763047|Primary|Binocular Distance Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.||LogMAR||Standard Deviation|Mean
20638|NCT01762982|Secondary|Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Number of participants|||Number
20639|NCT01762982|Secondary|Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Number of participants|||Number
20640|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Percentage of participants|||Number
20641|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Percentage of participants|||Number
20652|NCT01762800|Secondary|Percentage of Participants Who Stepped Down From TRIPLE Therapy to Initial Randomized Treatment|The percentage of participants who stepped down from TRIPLE therapy to initial randomized treatment was calculated as number of participants who step-down from TRIPLE therapy divided by number of participants who switch to TRIPLE therapy and then multiplied by 100.|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
20642|NCT01762982|Secondary|Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.||Number of participants|||Number
20643|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|Intention to Treat (ITT) population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment.||Percentage of participants|||Number
20644|NCT01762904|Secondary|Detect Presence of Allergy or Skin Reaction by the Antiseptic Application|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Presence of allergy or any skin reaction at 24 hours after the antiseptic application."|24 hours|||participants||Inter-Quartile Range|Median
20645|NCT01762904|Primary|Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab|"135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hrs|||(CFU/cm2)||Inter-Quartile Range|Median
20646|NCT01762904|Primary|Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours|||(CFU/cm2)||Inter-Quartile Range|Median
20647|NCT01762904|Primary|Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically|"135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours|||(CFU/cm2)||Inter-Quartile Range|Median
20648|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Physician|Physician evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|24 weeks|mITT population||Participants|||Number
20649|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Participants|Participants evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population||Participants|||Number
20650|NCT01762800|Secondary|Percentage of Participants Who Dropped Out|The percentage of participants who were withdrawn from the study.|24 weeks|All Subjects population: all participants who were enrolled into the study and whose data obtained at screening (visit1) was not missing and demography data was available.||Percentage of participants|||Number
20651|NCT01762800|Secondary|Percentage of Participants Who Required Additional Treatment to TRIPLE Therapy|The percentage of participants who required additional treatment to TRIPLE therapy is defined as number of participants who took additional medicine or therapy in TRIPLE therapy divided by number of participants who switch to TRIPLE therapy multiplied by 100.|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
20704|NCT01762501|Primary|Change in Nocturnal Systolic Blood Pressure Level|"Change at the end of a treatment period (Week 8) from the beginning point of an observation period~*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)"|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
20653|NCT01762800|Secondary|Percentage of Participants Who Used Relief Medication (Salbutamol)|Each evening participants recorded the number of occasions in the last 24 hours when they used their salbutamol for symptomatic relief of COPD symptoms. The percentage of participants who used relief medication in the study are presented.|24 weeks|mITT population||Percentage of participants|||Number
20654|NCT01762800|Secondary|Change From Baseline in FEV1|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. Baseline was a value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. FEV1 was assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Baseline (Visit 2) and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Liters||Standard Deviation|Mean
20655|NCT01762800|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. At Screening (Visit 1) spirometric assessments were conducted before (Visit 1A) and 30 to 60 minutes after a bronchodilator challenge (400 µg of salbutamol) (Visit 1B). FEV1 during each visit are presented. FEV1 was assessed at Visit 1A (Screening), Visit 1B (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Liters||Standard Deviation|Mean
20656|NCT01762800|Secondary|Change From Baseline in CAT Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Baseline was the value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. Scores were assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
20657|NCT01762800|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Scores were assessed at Visit 1 (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
20658|NCT01762800|Secondary|Comparison of Number of Exacerbations Between Two Detection Methods: EXACT and Physician Diagnosis|The comparison of number of exacerbation between two detection methods EXACT and physician diagnosis: number of exacerbations detected by EXACT and number of exacerbations judged by physician.|24 weeks|mITT population||Number of exacerbations||Standard Deviation|Mean
20659|NCT01762800|Secondary|E-RS Subscale Score|The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. The E-RS subscale scores for respiratory symptoms (RS)-breathlessness (RS-BRL), RS-cough and sputum (RS-CSP), and RS-chest symptoms (RS-CSY) are presented. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score. Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. RS total scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
20660|NCT01762800|Secondary|EXACT Respiratory Symptoms (E-RS) Total Score|"The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. Scores range from 0-100, high value in score indicate worse outcome."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
20661|NCT01762800|Secondary|EXACT Total Score.|"EXACT is a 14-item patient questionnaire used as a measure of respiratory symptoms (reported as units on a 0 [best health status] to 100 [worst possible status] scale). Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
20662|NCT01762800|Secondary|Time to First Exacerbation by EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)|The EXAcerbations of Chronic pulmonary disease Tool (EXACT) is a 14-item patient-reported outcome (PRO) daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Reported as units on a 0 [best health status] to 100 [worst possible status] scale). The day of detection of first exacerbation in any participant in each arm by EXACT.|24 weeks|||Days|||Number
20663|NCT01762800|Secondary|Time to First Exacerbation by Physician's Diagnosis|The day of detection of first exacerbation in any participant in each arm as diagnosed by physician. Exacerbation is defined primarily by physician’s judgment. Date of randomisation will be start point and timing of exacerbation (first exacerbation if there are more than one) will be event. For subjects without exacerbation, last day of study or follow up period is regarded as censor.|24 weeks|mITT population||Days|||Number
20664|NCT01762800|Secondary|Time to First Switching to TRIPLE Therapy|The day of first switch to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) for the first switching participant in each arm.|24 weeks|mITT population||Days|||Number
20665|NCT01762800|Secondary|Continuation Percentage of Participants Managed by Randomized Treatment Plus TRIPLE Therapy|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) was not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. Continuation TRIPLE proportion is defined as [(number of subjects who switched to TRIPLE) - (number of subjects who stepped down)/ number of evaluable population]*100. Randomised treatment continuation proportion is calculated by a formula: (100 - switch proportion).|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
20666|NCT01762800|Secondary|Percentage of Participants Managed by TRIPLE Therapy|Percentage of participants managed by TRIPLE therapy was calculated as [(number of participants who switched to TRIPLE therapy) - (number of participants who stepped down)/ number of evaluable population]*100|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
20667|NCT01762800|Secondary|Percentage of Participants Who Switched to TRIPLE Therapy|Switched to TRIPLE therapy is defined as: 1. Date of switch: when SAL/FLU or TIO was administered additionally to randomised treatment. 2. Date of randomisation was a start point and timing of switching (first switch if there are more than once) to TRIPLE was event. For participants without switching, last day of study or follow up period was regarded as censored. Percentage of participants who switched to TRIPLE therapy was calculated as: number of participants who switched to TRIPLE therapy divided by number of evaluable population and then multiplied by 100.|24 weeks|mITT population||Percentage of participants||95% Confidence Interval|Number
20668|NCT01762800|Primary|Percentage of Participants Who Were Able to Remain on the Randomized Treatment|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) is not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. The percentage of participants who were able to remain on the randomized treatment was calculated by the following formula: 100 minus percentage of participants who switched over to TRIPLE therapy.|24 weeks|Modified Intent-to-Treat (mITT) population: randomized participants who received at least a single dose of the investigational product.||Percentage of participants||95% Confidence Interval|Number
20669|NCT01762761|Secondary|Pharmacodynamic Parameter-Maturation Rate of Platelet Precursors (KOUT)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KOUT was fixed to 0.0253 /hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population||1/ hr|||Number
20670|NCT01762761|Secondary|Pharmacodynamic Parameter- Production Rate of Platelet Precursors (KIN)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KIN was fixed to 1.43x10^9/L.hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population||1 x 10^9/L.hr|||Number
20671|NCT01762761|Secondary|Pharmacodynamic Parameter-Linear Proportionality Constant of Drug Effect (SLOP): the Proportional Increase of Platelet Production Rate With Each 1-μg/mL Increase in Eltrombopag Plasma Concentration|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population||Milliliter/microgram||95% Confidence Interval|Geometric Mean
20672|NCT01762761|Secondary|Percentage of Participants Estimated as Responders to Eltrombopag by the Pharmacokinetic/ Pharmacodynamic Model|Responders are participants whose SLOP estimates are larger than zero. The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population: all participants with evaluable dosing, actual sampling time, and platelet count data.||Percentage of participants|||Number
20673|NCT01762761|Secondary|Post-hoc Estimates of Maximum Observed Concentration (Cmax) for Eltrombopag After 50 mg Once Daily Dose of Eltrombopag|Cmax is defined as maximum observed concentration after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag Cmax was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state Cmax of eltrombopag .is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Nanogram/ Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
20674|NCT01762761|Secondary|Post-hoc Estimates of Plasma Eltrombopag Area Under the Concentration-time Curve Over a Dosing Interval (AUC[0-tau]) After 50 mg Once Daily Dose of Eltrombopag|AUC[0-tau] is defined as area under the concentration-time curve over a dosing interval (24 hr) of Eltrombopag atsteady-state after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state AUC(0-tau) of eltrombopag is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Microgram* hour per milliliter(μg.hr/mL)||95% Confidence Interval|Geometric Mean
42887|NCT01420289|Secondary|Percent Improvement in Peak Walking Time|Percentage Improvement in the amount of time one can walk without pain|16 weeks|||Percentage Change||Standard Error|Mean
20675|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Lag Time (ALAG)|Absorption lag time (ALAG) is defined as the time taken for a drug to appear in the systemic circulation following administration. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hrs and 5 to 8 hrs post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Hour||95% Confidence Interval|Geometric Mean
20676|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Rate Constant (Ka)|Ka is defined as the absorption rate constant. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Per hour (1/hr)||95% Confidence Interval|Geometric Mean
20677|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Apparent Clearance (CL/F), Apparent Inter-compartmental Clearance (Q/F)|CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population||Liters per hour(L/hr)||95% Confidence Interval|Geometric Mean
20678|NCT01762761|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Volume of Distribution of Central Compartment (Vc/F), Apparent Volume of Distribution of Peripheral Compartment (Vp/F)|Vc/F is apparent volume of distribution of plasma (VDP) in central compartment and Vp/F is apparent VDP in peripheral compartment. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 minutes(min) for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population: all participants with evaluable dosing, actual sampling time, and eltrombopag concentration data.||Liters||95% Confidence Interval|Geometric Mean
20679|NCT01762761|Secondary|Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening|Bone marrow biopsy was performed at Screening and then obtained when clinically indicated. Whenever a peripheral blood smear confirmed the presence of immature or dysplastic cells, a bone marrow examination was performed. Myelofibrosis (MF) was graded from Grade MF-0 to MF-3 where MF-0=scattered linear reticulin with no intersections (cross-overs) corresponding to normal bone marrow; MF-1=loose network of reticulin with many intersections; especially in perivascular areas; MF-2=diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3=diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis.|Screening|Safety Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
20680|NCT01762761|Secondary|Number of Participants With a Change From Baseline in Visual Acuity|Visual acuity is a measure of the spatial resolution of the visual processing system. Acuity is a measure of visual performance and is unrelated to the eyeglass prescription required to correct vision. Normal visual acuity is commonly referred to as 20/20 vision. Evaluation was done for oculus sinister (OS) for the left eye, oculus dexter (OD) for the right eye. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population||Participants|||Number
20681|NCT01762761|Secondary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Finding at Baseline|Resting 12-lead ECG was obtained at Baseline. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. ECG was also obtained when there was clinical symptom that potentially related to cardiac dysfunction based on investigator’s judgement.|Baseline|Safety Population. Only those participants with data available at the specified time points were analyzed.||Particpants|||Number
20682|NCT01762761|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population||Beats per minute||Standard Deviation|Mean
20683|NCT01762761|Secondary|Change From Baseline in Diastolic Blood Pressure|Diastolic blood pressure was measured in sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population||mm Hg||Standard Deviation|Mean
20739|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20684|NCT01762761|Secondary|Change From Baseline in Systolic Blood Pressure|Systolic blood pressure was measured in the sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
20685|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters|Clinical hematology parameters hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell count evaluations were performed at Baseline, at all on-therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the NCI CTCAE V4.0: Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
20686|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), total bilirubin, albumin, alkaline phosphatase, calcium, potassium, creatinine, glucose and sodium were evaluated at Baseline, at all on therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE V4.0): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. For creatinine, Baseline is defined as the average of Screening and Day 1 values if available and prior to first dose. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
20687|NCT01762761|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of study treatment (Day 1) up to the end of Week 8 of Stage 1|Safety Population: all randomized participants who received at least one dose of the study treatment.||Participants|||Number
20688|NCT01762761|Secondary|Number of Participants That Reduced or Discontinued Baseline Concomitant ITP Medications During Stage 2 and Stage 3|The number of participants taking concomitant ITP medications on Day 1 of Stage 1 who had a decrease in the dose or frequency of ITP medication or stopped ITP medication at any point during Stage 2 or Stage 3 will be presented. The Baseline concomitant ITP medication for Stage 2 and Stage 3 is defined as ITP medications taken prior to the first dose of investigational product of Stage 1. This study is still ongoing and this endpoint can only be analyzed when the stage 2 and stage 3 complete.|From the start of Week 1 of Stage 2 to the end of last week of Stage 3||07/2016||||
20689|NCT01762761|Secondary|Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L|Maximum period of time a participant had a platelet count continously >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Weeks||Inter-Quartile Range|Median
20690|NCT01762761|Secondary|Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L|Total duration of time a participant had platelet count >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Weeks||Inter-Quartile Range|Median
20691|NCT01762761|Secondary|Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments|The number of participants with a platelet count >=50×10^9/L during at least 75% of their platelet count assessments was analyzed up to the end of Week 6 of Stage 1. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
20692|NCT01762761|Secondary|Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1|Rescue treatment is defined as either a new ITP medication, an increase in dose of concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
20703|NCT01762501|Secondary|Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**|"Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent)~** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP"|Baseline and 8 weeks|||mmHg||95% Confidence Interval|Mean
20693|NCT01762761|Secondary|Time to Response|Time to response is defined as time from the startin of treatment to the first time of achieving a platelet count >=50x10^9/L during the first 6 weeks of Stage 1. Time to response is summarized using Kaplan-Meier estimates and compared between treatment groups using a stratified log-rank test, stratifying for the use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no). The pike estimator of the treatment hazard ratio is based on the stratified log-rank test. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population.Only those participants (par.) with a response were analyzed (3 responders out of 50 participants in the placebo group and 60 responders out of 104 participants in the Eltrombopag group for calculating the statistics of time to response analysis).||Weeks||95% Confidence Interval|Median
20694|NCT01762761|Secondary|Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale grades were dichotomized into the following categories: no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4. Generalized linear mixed model with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
20695|NCT01762761|Secondary|Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale were dichotomized to indicate no bleeding vs bleeding, i.e. 0=grade 0 and 1=grades 1, 2, 3 or 4. Generalized linear mixed model was applied with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect. Bleeding incidences were recorded at Screening, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. All Bleeding incidences at each visit are presented.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
20696|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1|The number of participants achieving a platelet count >=30×10^9/L and at least 2 times the Baseline platelet count at least once during the first 6 weeks of Stage 1 were analyzed. The Baseline platelet count is defined as the platelet count taken on Day 1 of the study or within 48 hours prior to the first dose of investigational product. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population. One participant did not have a Baseline platelet count due to no platelet count collected on Day 1 or within 48 hours prior to the first dose of investigational product;therefore, this participant was not evaluable in this table.||Participants|||Number
20697|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50×10^9/L at least once during the first 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population||Participants|||Number
20698|NCT01762761|Primary|Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50x10^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1.||Participants|||Number
20699|NCT01762722|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.||percentage saturation||Full Range|Mean
20700|NCT01762501|Secondary|Change in 24-hour Mean Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
20701|NCT01762501|Secondary|Change in 24-hour Mean Systolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
20702|NCT01762501|Secondary|Change in Nocturnal Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks|||mmHg||Standard Deviation|Mean
20705|NCT01762345|Other Pre-specified|Percentage of Responders for SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||percentage of subjects|||Number
20706|NCT01762345|Other Pre-specified|Percentage of Responders for Pad Weight Gain||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||percentage of subjects|||Number
20707|NCT01762345|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = ‘Not at all,’ 1= ‘Slightly,’ 2 = ‘Moderately,’ or 3 ‘Greatly.’ The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at the end of treatment"||units on a scale||Inter-Quartile Range|Median
20708|NCT01762345|Secondary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||episodes/usage period||Inter-Quartile Range|Median
20709|NCT01762345|Secondary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"||grams/usage period||Inter-Quartile Range|Median
20710|NCT01762345|Primary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||episodes/usage period||Inter-Quartile Range|Median
20711|NCT01762345|Primary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"||grams/usage period||Inter-Quartile Range|Median
20712|NCT01761747|Secondary|Define the Response Rate to Ponatinib is Patients With FGFR Amplifications Versus Mutations|Identify the response rate to ponatinib for FGFR specific FGFR amplifications/mutations.|2 years|There were no observed responses on study so this outcome could not be determined.|||||
20713|NCT01761747|Secondary|Determine the Correlation FGFR Amplifications/Mutations With Patient Age, Sex, Disease Stage, Prior Response to Treatment and Smoking History|For subjects with FGFR amplifications and for FGFR mutations we will ascertain the age, sex, disease stage, prior response to treatment and smoking history from past medical records and measure whether there are differences in these variables among subjects with amplification versus mutation.|2 years|Too few subjects were enrolled on study to permit this outcome measure analysis.|||||
20714|NCT01761747|Secondary|Disease Control|Measure the disease control rate of patients treated with ponatinib|2 years|||percentage of subjects|||Number
20715|NCT01761747|Secondary|Overall Survival|Measure the overall survival time of patients treated with ponatinib|2 years|||days||Full Range|Mean
20716|NCT01761747|Secondary|Define Toxicities of Ponatinib|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|2 years|||participants|||Number
20717|NCT01761747|Secondary|Progression-free Survival|Establish the progression-free survival of patients with SCC treated with ponatinib as defined by time to development of progression by RECIST criteria.|2 years|||days||Full Range|Mean
20718|NCT01761747|Secondary|Prevalence of Specific FGFR Amplifications/Mutations in the Study Population|Test tumor DNA using molecular assays to measure the frequency of FGFR amplifications and mutations in study patients|2 years|2 participants had FGFR amplification, one with FGFR mutation||participants|||Number
20719|NCT01761747|Primary|Response Rate of Patients With Lung or Head and Neck SCC Treated With Ponatinib|"Investigate the response rate of patients with previously treated lung or head and neck SCC to ponatinib as defined by the proportion of subjects with investigator-assessed confirmed complete response (CR) or partial response (PR).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|||percentage of subjects with response|||Number
20720|NCT01761565|Primary|CST½|the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration|24|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||hours||Full Range|Median
20721|NCT01761565|Primary|Time to Steady State|Steady state, for the cohort, was assessed using Helmert’s method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05)|24 hours|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||hours|||Number
20737|NCT01761019|Primary|Investigator Global Assessment|This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.|12 weeks|||units on a scale||Standard Deviation|Mean
20738|NCT01760993|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20722|NCT01761565|Primary|Cmax|"For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1.~For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3"|24 hours in Treatment A, 37 hours in Treatment B|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||pg/mL||Standard Deviation|Mean
20723|NCT01761279|Other Pre-specified|Accuracy of Prediction of Polyp Surveillence Intervals|Accuracy of prediction of post-polypectomy surveillence colonoscopy intervasl based on national guidelines. Intervals based on in-vivo assessment of all polyps ≤5mm in size combined with histopathology of polyps >5mm in size will be compared to intervals determined by histopathology of all polyps|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|84 study participants in total. One patient excluded from this analysis as a single polyp was not retrieved for histological analysis.||Percentage correct surveillence interval|||Number
20724|NCT01761279|Secondary|Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size|Negative predictive value for adenomatous histology of rectosigmoid polyps ≤5mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. NPV compared to the gold standard of histopathology. Negative predictive value = number of true negatives/(number of true negatives + number of false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|Numbers indicate the number of rectosigmoid polyps <5mm in size assessed as being non-neoplastic||Percentage Negative Predictive Value|Participants|95% Confidence Interval|Number
20725|NCT01761279|Secondary|Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size|Specificity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Specificity compared to the gold standard of histopathology. Specificity for adenomatous histology = number of correctly identified non-neoplastic polyps (true negatives)/total number of non-neoplastic polyps (true negatives + false positives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|75 is the number of non-neoplastic polyps included in the study.||Percentage specificity|Participants|95% Confidence Interval|Number
20726|NCT01761279|Secondary|Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size|Sensitivity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Sensitivity compared to the gold standard of histopathology. Senstivity for adenomatous histology = number of correctly identified adenomas (true positives)/total number of adenomas (true positives + false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|134 is the number of adenomatous polyps included in the study.||Percentage sensitivity|Participants|95% Confidence Interval|Number
20727|NCT01761279|Primary|Diagnostic Accuracy of In-vivo Polyp Assessment|Diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Accuracy compared to the gold standard of histopathology. Accuracy - number of polyps with histology correctly predicted by in-vivo method/total number of polyps assessed (Expressed as a percentage)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|There were 84 patients included in the study. 209 polyps <10mm included in the study.||% diagnostic accuracy|Participants|95% Confidence Interval|Number
20728|NCT01761162|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
20729|NCT01761162|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
20730|NCT01761162|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
20731|NCT01761162|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.||percentage of participants||95% Confidence Interval|Number
20732|NCT01761162|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI|||percentage of participants||95% Confidence Interval|Number
20733|NCT01761019|Secondary|Desire to Change to Another Systemic Therapy|We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.|12 weeks|||Percentage of participants|||Number
20734|NCT01761019|Secondary|Patient Satisfaction|"• Subject satisfaction: We also ask subjects for their level of satisfaction with their current treatment at week 12. They will be given the following options: very satisfied, satisfied, somewhat disappointed or very disappointed. For measurement very satisfied=4, satisfied=3, somewhat disappointed=2 and very disappointed=1. We will determine the mean satisfaction of all patients at week 12."|12 weeks|||units on a scale||Standard Deviation|Mean
20735|NCT01761019|Secondary|Safety|Throughout this study, adverse events and serious adverse events will be collected|12 weeks|||adverse event|||Number
20736|NCT01761019|Secondary|Body Surface Area|This is a measure of the percentage of the body involved with psoriasis. We will measure the change in percentage of body area involved with psoriasis from baseline to week 12.|12 weeks|||percentage of body surface area||Standard Deviation|Mean
20740|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 52|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20741|NCT01760993|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20742|NCT01760993|Secondary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20743|NCT01760993|Primary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20744|NCT01760993|Primary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20745|NCT01760993|Primary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20746|NCT01760993|Primary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20747|NCT01760993|Primary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20748|NCT01760993|Primary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20749|NCT01760993|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20750|NCT01760993|Primary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20751|NCT01760993|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks||Basline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20752|NCT01760941|Other Pre-specified|Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile|Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile|6 months||||||
20753|NCT01760941|Secondary|Evaluate the Treatment Influence on Patient Quality of Life|Evaluate the treatment influence on patient quality of life as measured by the ESAS.|2 weeks||||||
20754|NCT01760941|Secondary|Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction|Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.|2 weeks||||||
20755|NCT01760941|Primary|Feasibility of Treatment Delivery in the Same Day as Initial Evaluation|Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey|Up to 6 months||||||
20756|NCT01760889|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20757|NCT01760889|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20758|NCT01760889|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20759|NCT01760889|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20760|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20761|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 26|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20762|NCT01760889|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20763|NCT01760889|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20764|NCT01760889|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20765|NCT01760889|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20766|NCT01760889|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20767|NCT01760889|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20768|NCT01760889|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20769|NCT01760889|Primary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
20770|NCT01760876|Secondary|OCT Endpoints (Neointimal Metrics), QCA Endpoints (Late Lumen Loss at 9 Months), and Clinical Endpoints (MACE at 9 Months and 12 Months). A Subgroup Analysis Would be Performed for Diabetic Patients.|Secondary endpoints would consist of OCT endpoints (neointimal area, neointimal thickness, neointimal volume, and percentage neointimal volume ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, including stent thrombosis up to 12 months). A subgroup analysis will be performed for DM patients.|9 months and 12 months||08/2016||||
20771|NCT01760876|Primary|OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months.|"The percentage of strut coverage and category of coverage (A to F) from 1 month to 9 months by longitudinal sequential OCT assessments.~A. Definitely uncovered – strut not covered by tissue, and both sides appear square; B. Uncovered with abnormal in-stent tissue – strut covered by irregular tissue or fibrin, and both sides appear square; C. Partially uncovered – strut partially covered by tissue but only one side has a smooth continuous shoulder; D. Covered (protruding) – strut covered by thin continuous tissue on both sides but still extending into the lumen; E. Covered (embedded) – strut covered by continuous tissue or neointima and not interrupting the smooth lumen contour; F. Covered (proliferative) – strut covered with excessive growth of neointima with thickness >0.3 mm."|1 to 9 months|100 patients treated with BF stents and randomly assigned to 5 monthly groups (n = 20:20:20:20:20) at 1 to 5 months receiving OCT follow-up, and then 100 patients altogether at 9 months for another follow-up.||percentage of strut coverage (D+E+F)||Inter-Quartile Range|Median
20772|NCT01760785|Secondary|Frequency of Alcohol Use|Frequencies of alcohol use/misuse will be measured weekly utilizing the Timeline Followback assessment. Participants will also be given an alcohol breath test at every clinic visit.|Weeks 1-10||||||
20773|NCT01760785|Primary|Severity of Affective Lability Based on Shortened Agitated Behavior Scale|Severity of affective lability was measured using a shortened version of the Agitated Behavior Scale (ABS). The ABS is used to assess the nature and extent of present agitation. Eight items from the 14-item scale were used, which measured the presence and severity of various affective lability symptoms including: short attention span, impulsivity, uncooperative behavior, violent tendencies, restlessness, rapid or excessive talking, sudden changes in mood, and easily initiated or excessive crying and/or laughter. Each of the eight items was scored using a 1-4 Likert scale, where 1 stands for absence of symptom and 4 stands for presence to an extreme degree. The minimum possible score for this measure was 8, and the maximum possible score was 32. Due to the nature of the measure, a lower score indicated less severe affective lability, while conversely higher scores indicated more severe affective lability. The mean of scores for weeks 2 through 8 for each group were reported.|Weeks 2 through 8|||units on a scale||Standard Error|Mean
20774|NCT01759602|Secondary|Expanded Disability Status Score (EDSS)|"The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of patients with multiple sclerosis. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers.~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. In addition, it also provides eight subscale measurements called Functional System (FS) scores."|participants were followed for the duration of hospital stay ranging from 5-21 days, an average of 13 days; EDSS assessment was administered at discharge|||EDSS scores||Full Range|Median
20775|NCT01759602|Secondary|Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters.|"ALT elevations were considered mild if they rose to less than 4-fold baseline levels."|5-21 days|||participants|||Number
20776|NCT01759602|Secondary|Percentage of Subjects Withdrawing Due to Adverse Events.||5-21 days|||percentage of subjects withdrawing|||Number
20777|NCT01759602|Secondary|Frequency of Serious Adverse Events.||5-21 days|||serious adverse events|||Number
20778|NCT01759602|Primary|Number of Adverse Safety Events During Hospitalization|Over the course of hospitalization for the acute NMO exacerbations, subjects will be monitored daily for frequency of adverse events.|5-21 days|||adverse safety events|||Number
20779|NCT01759420|Secondary|Number of Adverse Events|The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient. All of these outcomes will be recorded for each patient during the emergency department stay which could range from 20 minutes to several hours.|20 minutes to 8 hours|||percentage of patients||95% Confidence Interval|Number
20780|NCT01759420|Primary|Change in QTc Interval With Ondansetron Administration|The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. A baseline EKG will be obtained and then after drug administration an EKG will be performed every 2 minutes until 20 minutes has passed. The mean maximal QTc change will be calculated.|Baseline to 20 minutes|||mS||95% Confidence Interval|Mean
20781|NCT01759381|Primary|Number of Participants With Post-operative Infection (NPWT)|The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.|3 months|||participants|||Number
20782|NCT01759368|Secondary|Utilization of Health Care Resources|Number of visits to nurse's reception|From baseline until the end of the study at six months|||number of visits||Standard Deviation|Mean
20783|NCT01759368|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline until the end of the study|From baseline until the end of the study at six months|||percentage unit||95% Confidence Interval|Mean
20784|NCT01759368|Other Pre-specified|Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study|Change in plasma concentrations of creatinine, natrium, and potassium|From baseline to the end of the study at six months||||||
20852|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
20785|NCT01759368|Secondary|EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores|Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed.|From baseline until the end of the study at six months|||Scores on a scale||95% Confidence Interval|Mean
20786|NCT01759368|Secondary|P-proBNP|Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.|From baseline until the end of the study at six months|||ng/l||Inter-Quartile Range|Median
20787|NCT01759368|Secondary|Heart Transplant|Heart transplant operation or listing for transplant operation|From baseline until the end of the study at six months|||participants|||Number
20788|NCT01759368|Secondary|Death|Death from any cause|From baseline until the end of the study at six months|||participants|||Number
20789|NCT01759368|Primary|Number of HF-related Hospital Days|Number of heart failure related hospital days|From baseline until the end of the study at six months|||number of days||Standard Deviation|Mean
20790|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20791|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20792|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20793|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20794|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20795|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20796|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20797|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20798|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20799|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20800|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20801|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20802|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20803|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20804|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20805|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20806|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20807|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20808|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20809|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20810|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20811|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20812|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20813|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20858|NCT01759251|Secondary|Change of the Patient’s Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period|determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|From Day 0 to 2 months||||||
20814|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20815|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20816|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20817|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20818|NCT01759290|Secondary|All Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20819|NCT01759290|Secondary|Cardiac Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20820|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20821|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20822|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20823|NCT01759290|Secondary|All Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20824|NCT01759290|Secondary|Cardiac Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20825|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20826|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
42888|NCT01420289|Primary|Mean Percent Reduction in Wound Surface Area||baseline and 16 weeks|||Percent reduction in wound surface area||Standard Error|Mean
20827|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20828|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20829|NCT01759290|Secondary|All Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20830|NCT01759290|Secondary|Cardiac Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20831|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20832|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 - 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20833|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20834|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20835|NCT01759290|Secondary|All Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20836|NCT01759290|Secondary|Cardiac Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20837|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20838|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20853|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
20854|NCT01759251|Secondary|Overall Clinical Response Assessed by Patient|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months||||||
20839|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20840|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20841|NCT01759290|Secondary|Late Scaffold Thrombosis||31 to 365 Days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.||percentage of participants|||Number
20842|NCT01759290|Secondary|Subacute ScaffoldThrombosis||1 to 30 days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.||percentage of participants|||Number
20843|NCT01759290|Secondary|Acute Scaffold Thrombosis||<1 day|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.||percentage of participants|||Number
20844|NCT01759290|Secondary|Acute Success: Clinical Procedure Success (Per Subject Analysis)|Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.|During the hospital stay with a maximum of 3 days post index procedure|||percentage of participants||95% Confidence Interval|Number
20845|NCT01759290|Secondary|Acute Success: Clinical Device Success (Lesion Level Analysis)|Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.|< or = 1 day|||percentage of lesions|Participants|95% Confidence Interval|Number
20846|NCT01759290|Primary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).||percentage of participants||95% Confidence Interval|Number
20847|NCT01759264|Secondary|Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment|CR70 and CR100 was a decrease from baseline (Week 0) in CDAI score of 70 and 100 or more points, respectively, a lower score indicating improvement in disease activity.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
20848|NCT01759264|Secondary|Percentage of Participants With Remission of Crohn's Disease|Crohn's Disease Activity Index (CDAI) was a composite index consisting of a weighted scoring of eight disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, a higher score indicates increased disease severity. Clinical remission was defined as CDAI score less than 150.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
20849|NCT01759264|Secondary|Mean Percent Change of Fecal Calprotectin From Baseline|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage||Standard Deviation|Mean
20850|NCT01759264|Primary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 4|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
20851|NCT01759264|Secondary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 8 and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).||Percentage of participants|||Number
20859|NCT01759251|Primary|Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|Number of patients with clinical response on treatment determined with SVVSLCRE|Up to 2 months|60 days treatment group||participants|||Number
20860|NCT01759160|Secondary|CVP (Central Venous Pressure)|CVP was continuously monitored to assess preload condition and served to calculate SVRI (systemic vascular resistance index) every minute during the first 25 minutes of infusion.|25 minutes after induction||||||
20861|NCT01759160|Secondary|NI (Narcotrend Index) Reduction|Narcotrend was utilized to continuously record patients' sedation level during induction, provided as a criteria for Cpt (Plasma Target Concentration) adjustment.|25 minutes after propofol infusion||||||
20862|NCT01759160|Primary|SVI (Stroke Volume Index) Value Change From Baseline Level at the End of the First 25 Minutes.|After propofol infusion started, according to sedation level, TCI targets were gradually titrated to reach a state of equilibrium at the end of the first 25 minutes. SVI were continuously monitored, at the end of the first 25 minutes, value change from baseline level were calculated.|The end of the first 25 minutes after propofol infusion|||ml/beat/m^2||Standard Deviation|Mean
20863|NCT01758900|Secondary|Complication Rate||Within 1 week after all the examinations are finished|||participants|||Number
20864|NCT01758900|Secondary|Abdominal Circumference|To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure.|10 minutes before/after the examination|||centimeter||Standard Deviation|Mean
20865|NCT01758900|Secondary|Procedure Time||Within 5 minutes after the examination|||minutes||Standard Deviation|Mean
20866|NCT01758900|Secondary|Patient's Acceptability|Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled “no pain/distention” on left end and the 10-cm point labeled “very severe pain/distention that cannot be tolerated” on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination.|6 hours after the examination|||participants|||Number
20867|NCT01758900|Secondary|Diagnostic Rate||Within 1 week after all the examinations are finished|||Percentage of Participants|||Number
20868|NCT01758900|Secondary|Total Enteroscopy Rate||Within 1 week after all the examinations are finished|||participants|||Number
20869|NCT01758900|Primary|Intubation Depth||Within 5 minutes after the examination|||cm||Standard Deviation|Mean
20870|NCT01758289|Secondary|Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)|Participants with a complete, valid assessment at given time point.||units on a scale||Standard Deviation|Mean
20871|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.||units on a scale||Standard Deviation|Mean
20872|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from ‘no problem’ to ‘extreme problem’) best describes their health state.|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.||participants|||Number
20873|NCT01758289|Secondary|Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks|Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).|Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|All participants; n=number of participants with valid PTH values at given time point.||participants|||Number
20874|NCT01758289|Secondary|Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL|Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).|Baseline to Week 12, Week 12 to Week 24|All participants; n=participants with valid PTH values at given time point.||participants|||Number
20875|NCT01758289|Secondary|Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24|"Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL.~Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL.~Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL)."|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.||percentage of participants|||Number
20876|NCT01758289|Primary|Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit||Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|Participants with valid PTH values at Baseline and Final Study Visit.||percentage of participants|||Number
20891|NCT01757691|Primary|Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo|Due to early termination and low patient enrollment the primary outcome measure was not analyzed|Baseline and Week 18||||||
20892|NCT01757561|Other Pre-specified|Blood Gas Analysis|including artery blood and blood from jugular vein bulb|baseline,every hour in the operation,after extubation||||||
20877|NCT01757964|Primary|Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring|The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.|12 weeks|||participants|||Number
20878|NCT01757847|Secondary|Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months|The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.|post treatment (4 weeks), 3 months, 6 months|Participants with measurement at baseline and at least one other time point.||units on a scale||Standard Deviation|Mean
20879|NCT01757847|Primary|Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months|This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.|post treatment (4 weeks), 3 months, 6 months|participants with measurement at baseline and at least one other time point.||units on a scale||Standard Deviation|Mean
20880|NCT01757704|Primary|Duration of the De-airing Procedure|The de-airing procedure is deemed completed when the Trans-esophageal Echocardiography (TEE) no longer visualizes air emboli in the heart Chambers. The duration is likely to vary between individuals and reflects the complexity of the de-airing procedure.|Time from release of aortic crossclamp to finished de-airing|||Minutes||Inter-Quartile Range|Median
20881|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|6-10 minutes after finished de-airing|||Participants|||Number
20882|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|3-6 minutes after finished de-airing|||Participants|||Number
20883|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|0-3 minutes after finished de-airing|||Participants|||Number
20884|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Period of ten minutes after finished de-airing|||Air microemboli||Inter-Quartile Range|Median
20885|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from cardiac ejection to finished de-airing, an average of 5-10 minutes|||Air microemboli||Inter-Quartile Range|Median
20886|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes|||Air microemboli||Inter-Quartile Range|Median
20887|NCT01757691|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60|Safety population consited of all patients who received at least one dose of study medication||Participants|||Number
20888|NCT01757691|Secondary|Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48||||||
20889|NCT01757691|Secondary|Vision Based Quality of Life (QoL) Utility Score|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48||||||
20890|NCT01757691|Secondary|Low Contrast Visual Acuity (LCVA)|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 48||||||
20893|NCT01757561|Other Pre-specified|Vital Signs|heart rate, artery blood pressure,pulse oxygen saturation,temperature|baseline , evey hour in the operation,afte extubation||||||
20896|NCT01757561|Secondary|the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia|The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline.|1-3days、5-7days after operation|||participants|||Number
20897|NCT01757561|Primary|the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia|SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2<50%.|baseline ,every hour in the operation period,after extubation|||participants|||Number
20898|NCT01757405|Secondary|Percentage of Participants With Inhibitor Development to FVII|Development of rFVII inhibitors or FVIIa binding antibodies during the study.|6 months (throughout study period)|Safety Analysis Dataset||percent of participants|||Number
20899|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).~Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judges the AE to be possibly related or probably related to rFVIIa BI.~The percentage of AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related [to rFVIIa BI])."|6 months (throughout study period)|Safety Analysis Dataset||percent of AEs|adverse events||Number
20900|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Percentage of Participants With Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).~Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judged the AE to be possibly related or probably related to rFVIIa BI.~The percentage of participants with AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related to rFVIIa BI)."|6 months (throughout study period)|Safety Analysis Dataset||percent of participants with AEs|||Number
20901|NCT01757405|Secondary|Percentage of Clinical Responders (Sustained Bleeding Control) for All Acute Bleeding Episodes|Clinical responders defined as sustained bleeding control, (no additional hemostatic medication including rFVIIa BI required between 12 and 24 hours after first infusion of the successfully treated bleeding episode).|24 hours post infusion|Full Analysis Dataset||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
20902|NCT01757405|Secondary|Treatment Response for Each Bleeding Episode|"Participants rated the treatment of each bleeding episode. If treatment occurred under direct supervision of treating physician, the physician rated the response.~Ratings based on a 4 point scale; EXCELLENT - full relief of pain and cessation of objective signs of bleeding (swelling, tenderness, decrease in range of motion [for muscle bleeds]) within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.~GOOD - Substantial relief of pain and/or cessation of objective signs of bleeding within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.~MODERATE - slight relief of pain and slight improvement of signs of bleeding within 9 hours of treatment initiation. Requires additional infusion beyond treatment regimen.~NONE - No improvement or condition worsens. SUCCESSFUL = EXCELLENT or GOOD."|within 24 hours of infusion|Full Analysis Dataset||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
20903|NCT01757405|Primary|"Percentage of Bleeding Episode With Treatment Success"|No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen.|within 12 hours of first dose|Full Analysis Dataset||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
20904|NCT01757275|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days|FAS||blood units|||Number
20905|NCT01757275|Secondary|Number of Blood Units Transfused Within 72 Hours||within 72 hours|FAS||blood units|||Number
20906|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 30 Days||within 30 days|FAS||participants|||Number
20907|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 72 Hours||within 72 hours|FAS||participants|||Number
20908|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 30 Days||30 days|FAS||participants|||Number
20909|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 72 Hours||72 hours|FAS||participants|||Number
20910|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 30 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|30 days|FAS||participants|||Number
20937|NCT01756300|Secondary|Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .||percentage of participants|||Number
23987|NCT01702311|Secondary|Daily Dose of Insulin|Compare the daily dose of insulin used among both groups|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
20911|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 7 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|7 days|FAS||participants|||Number
20912|NCT01757275|Primary|Rate of Clinically Significant Rebleeding Within 72 Hours|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|72 hours|Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS.||participants|||Number
20913|NCT01757184|Secondary|Percentage Change From Baseline in Liver Volume|Relative reduction (percentage change from baseline) in liver volume, as assessed by magnetic resonance imaging, in the subset of subjects for whom imaging was performed|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an MRI assessment of liver volume at baseline and the last time point in the double-blind period.||percentage change from baseline||Standard Deviation|Mean
20914|NCT01757184|Secondary|Number of Subjects With Improvement in Liver Histology (Decrease of >5% in Hepatic Steatosis Score)|The number of subjects who had an improvement in hepatic histology (i.e., a decrease of >5% in hepatic steatosis score) from baseline to Week 20, as determined by blinded central review, in the subset of subjects for whom liver biopsy was performed.|Baseline to the end of the double-blind period (week 20)|||participants w/ improved liver histology|||Number
20915|NCT01757184|Secondary|Percentage Change From Baseline in Liver Fat Content|Decrease in liver fat content, as assessed by magnetic resonance imaging (MRI), in the subset of subjects for whom imaging was performed|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an MRI assessment of liver fat content at baseline and the last time point in the double-blind period. (Note: liver fat content could only be determined for subjects able to breath-hold for 15-30 seconds, unlike liver volume.)||percentage change from baseline||Standard Deviation|Mean
20916|NCT01757184|Secondary|Percentage Change From Baseline in HDL-c|Relative increase (percentage change from baseline) in high density lipoprotein cholesterol (HDL-c) at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
20917|NCT01757184|Secondary|Percentage Change From Baseline in Triglycerides|Relative reduction (percentage change from baseline) in triglycerides at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
20918|NCT01757184|Secondary|Percentage of Subjects Achieving Aspartate Aminotransferase (AST) Normalization|The percentage of subjects with an abnormal baseline aspartate aminotransferase (AST; i.e., >ULN) who achieved AST normalization, based on age- and gender-specific normal ranges provided by the central laboratory performing the assay.|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an abnormal AST level at baseline. (One subject in the placebo group had a normal AST level at baseline and was therefore excluded from this analysis.)||percentage of subjects|||Number
20919|NCT01757184|Secondary|Percentage Change From Baseline in Non-HDL-c|Relative reduction (percentage change from baseline) in non-high density lipoprotein cholesterol (non-HDL-c) at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
20920|NCT01757184|Secondary|Percentage Change From Baseline in LDL-c|Relative reduction (percentage change from baseline) in LDL-c at the end of the double-blind period.|Baseline to the end of the double-blind period (week 20)|||percentage change from baseline||Standard Deviation|Mean
20921|NCT01757184|Primary|Percentage of Subjects Achieving Alanine Aminotransferase (ALT) Normalization|The primary efficacy endpoint was the percentage of subjects who achieve alanine aminotransferase (ALT) normalization (i.e., ALT below the age- and gender-specific upper limit of normal provided by the central laboratory performing the assay) at the end of the double-blind treatment period (i.e., the last double-blind assessment), relative to placebo.|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an abnormal ALT level at baseline.||percentage of subjects|||Number
20922|NCT01756976|Primary|Washed RBC Hematocrit|The Hematocrit of the RBC shall be > 50%.|< 4 hours|||percentage of HcT||Standard Deviation|Mean
20923|NCT01756391|Primary|Maximum Symptom Days/14 Days|"Largest value among the following:~Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma"|14 days|Those with appropriate follow up and school/home allergen exposure data and allergy sensitization data||days||Standard Deviation|Mean
20924|NCT01756391|Secondary|Exhaled Nitric Oxide Levels||12 months||||||
20925|NCT01756391|Secondary|Percent Change in FEV1 After Short-acting Beta Agonist||12 months||||||
20926|NCT01756391|Secondary|FEV1 Percent Predicted||12 months||||||
20927|NCT01756391|Secondary|FEV1/FVC||12 months||||||
20938|NCT01756300|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .||percentage of participants|||Number
20939|NCT01756300|Secondary|Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.|From baseline to 3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .||mmHg||Standard Deviation|Mean
20940|NCT01756300|Secondary|Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.|From baseline to 1 ,3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and radiofrequency (RF) energy is successfully applied in at least one artery. .||mmHg||Standard Deviation|Mean
20941|NCT01756300|Secondary|Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
20942|NCT01756300|Primary|The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.|The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.||percentage of participants|||Number
20943|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies in the Neonatal Intensive Care Unit (NICU) That Produced Meter Results Beyond What Random Chance Would Predict (i.e., Outside 95% Limits for Studentized Residuals)|To evaluate how the meter systems perform with blood samples drawn in the Neonatal Intensive Care Unit, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies in Neonatal Intensive Care was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis and, of these, thirty (30) blood samples were obtained from babies in the Neonatal Intensive Care Unit (NICU).||BLOOD SAMPLES|BLOOD SAMPLES From Babies in the NICU||Number
20944|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies Less Than 24 Hours Old That Produced Meter Results Beyond What Random Chance Would Predict (i.e. Outside 95% Limits for Studentized Residuals)|To evaluate the effect of neonatal age on the meter systems' performances, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies less than 24 hours old was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis. Of these, twenty five (25) blood samples were obtained from babies that were less than 24 hours old.||BLOOD SAMPLES|BLOOD SAMPLES From Babies <24 hours old||Number
20945|NCT01756274|Secondary|Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.||percentage of BLOOD GLUCOSE RESULTS|BLOOD SAMPLES||Number
20965|NCT01755702|Secondary|Number of Participants With Complete Headache Relief|Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of ‘no headache’ over total number of participants. These calculations were based on one headache per treatment per subject.|Baseline to 2 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Participants|||Number
20946|NCT01756274|Primary|Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.||percentage of Blood Glucose Results|Blood Samples||Number
20947|NCT01756157|Secondary|Number of Angioedema Attacks Requiring Acute Treatment During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||angioedema attacks||Standard Deviation|Mean
20948|NCT01756157|Secondary|Cumulative Symptomatic Days During the Treatment Period|Cumulative symptomatic days was defined as the sum of the symptomatic days of each angioedema attack reported during the treatment period. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. Cumulative symptomatic days was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||days||Standard Deviation|Mean
20949|NCT01756157|Secondary|Cumulative Daily-severity During the Treatment Period|"Cumulative Daily-severity score was the sum of the severity scores recorded for every day of reported symptoms during the treatment period.~Severity scores were recorded as None=0, Mild=1, Moderate=2, and Severe=3. None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.~Cumulative daily severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.~The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||Score on a scale||Standard Deviation|Mean
20950|NCT01756157|Secondary|Cumulative Attack-severity During the Treatment Period|"Cumulative Attack-severity score was the sum of maximum symptom severity recorded for each angioedema attack, determined on the last day of symptoms and recorded as None=0, Mild=1, Moderate=2, and Severe=3 and summing over the unique attacks, yields a Cumulative Attack-severity score.~None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.~Cumulative attack-severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.~The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population||Score on a scale||Standard Deviation|Mean
20951|NCT01756157|Primary|Normalized Number of Angioedema Attacks During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|Intent-to-treat efficacy (ITT-E) population included all participants who completed both randomized treatment periods and fulfilled a priori defined evaluability criteria.||angioedema attacks||95% Confidence Interval|Mean
20952|NCT01756079|Primary|Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period||Percentage of participants|||Number
20953|NCT01756079|Primary|Percentage of Participants With One or More Adverse Events|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period||Percentage of participants|||Number
20954|NCT01756079|Primary|Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.|Week 72 (24 weeks after end of treatment)|The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period.||Percentage of participants||95% Confidence Interval|Number
20966|NCT01755702|Secondary|Time to Rescue Medication|Time to rescue medication was evaluated.|Baseline to 6 hours post dose|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||minutes||Full Range|Median
20983|NCT01755234|Secondary|Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.|Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.|Discharge from PACU to 24 hours post operative after PACU discharge.|||mg morphine equivalents||Inter-Quartile Range|Median
20955|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.~To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.~Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).~All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.~NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.||Milliseconds||Standard Deviation|Mean
20956|NCT01756053|Secondary|Effects of ABT-089 on Days of Biochemically-confirmed Abstinence|Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a ~4-day monitored abstinence phase within each period.|Days 7, 8, 9, 10, 38, 39, 40, & 41|Only participants completing both study periods (n=13) were included in the analyses.||Days of abstinence||Standard Deviation|Mean
20957|NCT01756053|Secondary|Effects of ABT-089 on Cigarette Ratings|Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 (“Not at all”) to 7 (“Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
20958|NCT01756053|Secondary|Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms|ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
20959|NCT01756053|Secondary|Effects of ABT-089 on Smoking Urges/Craving|QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
20960|NCT01756053|Secondary|Effects of ABT-089 on Withdrawal Symptoms|MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A “withdrawal discomfort score” was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
20961|NCT01756053|Secondary|Effects of ABT-089 on Mood|PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.||Scores on a scale||Standard Deviation|Mean
20962|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.~To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.~Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).~All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.~NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.||Number of correct responses (out of 60)||Standard Deviation|Mean
20963|NCT01755702|Secondary|Patients Global Assessment in Response to Treatment|Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.|Baseline to 8 weeks|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale|||Number
20964|NCT01755702|Secondary|Headache Severity|"Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.~Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
21001|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|ALT/AST ratio|change from baseline at 6 weeks|||Ratio||Standard Deviation|Mean
20967|NCT01755702|Secondary|Sum of TOTPAR and SPID (SPRID)|"Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:~SPRIDt = TOTPARt + SPIDt~TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
20968|NCT01755702|Secondary|Sum of Pain Intensity Difference (SPID)|"Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes – calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.~Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.~It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
20969|NCT01755702|Secondary|Total Pain Relief (TOTPAR)|"TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~It was calculated using the following formula.~TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
20970|NCT01755702|Secondary|Headache Relief Scores|Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
20971|NCT01755702|Primary|Time to First Perceptible Headache Relief|Time to first perceptible pain relief, calculated as time when partcipant selected ‘a little’ pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to ‘a little’ pain relief.|Baseline to 6 hours|Intention to treat (ITT) population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.||minutes||Full Range|Median
20972|NCT01755637|Secondary|Cmax of Active Metabolite - Albendazole Sulphoxide|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||ng/mL||Standard Deviation|Mean
20973|NCT01755637|Secondary|AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide|AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.||ng.hr/mL||Standard Deviation|Mean
20974|NCT01755637|Secondary|AUC (0-t) of Active Metabolite - Albendazole Sulphoxide|AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.||ng.hr/mL||Standard Deviation|Mean
20975|NCT01755637|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole|Tmax was time at which Cmax of Albendazole was reached.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.||hr||Full Range|Median
20976|NCT01755637|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||ng/mL||Standard Deviation|Mean
20977|NCT01755637|Primary|AUC [0-infinity (Inf)] of Albendazole|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||ng.hr/mL||Standard Deviation|Mean
20978|NCT01755637|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.|AUC (0-t) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.||nanogram (ng).hr per milliliter (mL)||Standard Deviation|Mean
20979|NCT01755455|Secondary|Change From Baseline in Sputum Iron (ng/mg) at 6 Weeks||Baseline and 6 weeks|||ng/mg||Standard Error|Mean
20980|NCT01755455|Secondary|Change From Baseline in Transferrin Saturation (%) at 6 Weeks||Baseline and 6 weeks|||% saturation||Standard Error|Mean
20981|NCT01755455|Secondary|Change From Baseline in Serum Iron (mcg/dl) at 6 Weeks||Baseline and 6 weeks|||mcg/dl||Standard Error|Mean
20982|NCT01755455|Primary|Change From Baseline in Hemoglobin Concentration (gm/dl) at 6 Weeks||Baseline and 6 weeks|||gm/dl||Standard Error|Mean
20984|NCT01755234|Secondary|Pain in Post Anesthesia Care Unit|"Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain and time in the Post Anesthesia Care Unit.~The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC."|Time in the post anesthesia care unit|||Pain Score * minutes in PACU||Inter-Quartile Range|Median
20985|NCT01755234|Secondary|Mg of Morphine Equivalents (IV)|Total opioid use in the post operative care unit (Mg of morphine equivalents)|PACU admission to discharge|||miligrams of morphine equivalents||Inter-Quartile Range|Median
20986|NCT01755234|Primary|Quality of Recovery Score 24 Hours Post Operative|Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.|24 hours after the surgical procedure|||units on a scale||Inter-Quartile Range|Median
20987|NCT01755169|Primary|Number of Participants With Dose Limiting Toxicity|A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.|2 weeks|||Participants|||Count of Participants
20988|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|||participants|||Number
20989|NCT01755143|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee|During MRI scans (9-12 weeks post-implant)|||participants|||Number
20990|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.||participants|||Number
20991|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|||participants|||Number
20992|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.||participants|||Number
20993|NCT01755143|Primary|MRI-related Complication Free Rate|Number of patients free of MRI-related complications|MRI scan to one month later|Patients who underwent an MRI||participants|||Number
20994|NCT01755026|Primary|Cefazolin Levels|Cefazolin levels|2 hours|||mcg/mL||Standard Error|Mean
20995|NCT01754922|Primary|Heart Rate Variability|ratio of low-frequency to high-frequency power|Resting baseline; cross-sectional|Signal quality of the the electrocardiogram was poor for 3 individuals; therefore, their data were removed from final analysis.||arbitrary units (LF:HF)||Standard Deviation|Mean
20996|NCT01754922|Primary|VO2 Peak|Maximal oxygen consumption measured during exercise|At peak exercise; cross-sectional|4 participants were excluded due to failure to meet maximal exercise criteria (3 from exposed, 1 from control). Therefore, we removed these individuals from the final analysis.||ml/min/kg||Standard Deviation|Mean
20997|NCT01754922|Primary|FEV1|Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge|Pre/post exercise; cross-sectional|||percentage of predicted normal values||Standard Deviation|Mean
20998|NCT01754766|Secondary|Conjunctival Hyperemia Score|Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point||Score on a scale||Standard Deviation|Mean
20999|NCT01754766|Secondary|Ocular Itching Score at Day 15|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 15|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point||Score on a scale||Standard Deviation|Mean
21000|NCT01754766|Primary|Ocular Itching Score at Day 1|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point||Score on a scale||Standard Deviation|Mean
21002|NCT01754714|Secondary|Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*|||mcg/mL||Standard Deviation|Mean
21003|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Hyaluronic acid|change from baseline at 6 weeks|||ng/mL||Standard Deviation|Mean
21004|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Caspase-cleaved cytokeratin (CK 18)|change from baseline at 6 weeks|||U/L||Standard Deviation|Mean
21005|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|oxidative stress marker (isoprostane level)|change from baseline at 6 weeks|||ng/mg Crea||Standard Deviation|Mean
21006|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|glutathione in erythrocytes|change from baseline at 6 weeks|||mcmol/g||Standard Deviation|Mean
21007|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|C-reactive Protein (CRP)|change from baseline at 6 weeks|||nmol/L||Standard Deviation|Mean
21008|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Adiponectin|change from baseline at 6 weeks|||mcg/mL||Standard Deviation|Mean
21009|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|glycosylated hemoglobin (HbA1c)|change from baseline at 6 weeks|||Percentage||Standard Deviation|Mean
21010|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting plasma insulin|Change from baseline at 6 weeks|||pmol/L||Standard Deviation|Mean
21011|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Time to peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||minutes||Inter-Quartile Range|Median
21012|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||Atom %C13||Standard Deviation|Mean
21013|NCT01754714|Secondary|Methionine Volume of Distribution at Week 7 (L)|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||L||Standard Deviation|Mean
21014|NCT01754714|Secondary|The Metabolic Clearance Rate Measured in the Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||L/h||Standard Deviation|Mean
21015|NCT01754714|Other Pre-specified|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|"Non-invasive test for liver disease (ActiTest)/Fibrotest~FibroTest® : diagnoses hepatic fibrosis ActiTest® : assesses viral necro-inflammatory activity Scores between 0 and 1, the higher the score the worse~The FibroTest score is calculated from the results of a six-parameter blood test, combining six serum markers with the age and gender of the patient:Alpha-2-macroglobulin, Haptoglobin, Apolipoprotein A1, Gamma-glutamyl transpeptidase (GGT), Total bilirubin, and Alanine transaminase (ALT). ALT is used in a second assessment called ActiTest that is part of FibroTest."|change from baseline at 6 weeks|||scores on a scale||Standard Deviation|Mean
21016|NCT01754714|Other Pre-specified|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|Cytokine profile ( Interleukin-6, IL-8, IL-10 (IL), Tumor Necrosis Factor (TNF -α), monocyte chemoattractant protein (MCP-1), and Granulocyte-colony stimulating factor (G-CSF ).|change from baseline at 6 weeks|||pg/mL||Standard Deviation|Mean
21017|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.|change from baseline at 6 weeks|||mmol/L||Standard Deviation|Mean
21018|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)|change from baseline at 6 weeks|||U/L||Standard Deviation|Mean
21019|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||percentage of recovery||Standard Deviation|Mean
21020|NCT01754714|Secondary|Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||mcg/mL||Standard Deviation|Mean
21021|NCT01754714|Primary|Methionine Elimination Half-life Measured in Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*|||hour||Standard Deviation|Mean
21022|NCT01754623|Secondary|Overall Survival (OS) Rate|OS at time of analysis, calculated from date of enrollment to date of death from any cause.|12 months|All participants per group||percentage of participants|||Number
21023|NCT01754623|Secondary|Progression-Free Survival (PFS) at Three Years|PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.|3 years|Evaluable participants at 3 years.|||||
21024|NCT01754623|Primary|Margin-negative (R0) Resection Rate|R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.|Up to 3 years|All participants with resection||percentage of participants|||Number
21098|NCT01752907|Secondary|Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation||units on a scale * days||Standard Error|Mean
21025|NCT01754493|Secondary|Somatization Module of the Patient's Health Questionnaire (PHQ-15)|Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
21026|NCT01754493|Secondary|Visual Analogue Scales (VAS)|Five self-report 11-point Likert scales measuring pain severity in the following domains (one item each): overall pain, pain interfering with daily activities, headaches, back pain, and shoulder pain. Range is 0-10; higher scores indicate higher pain severity.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
21027|NCT01754493|Secondary|Clinician-Rated Global Impression Scales (CGI)|Two clinician-administered scales measuring level of change in (1) depressive symptoms and (2) IBS symptoms, assessed separately. Range is 1-7, ranging from very much improved (1) to very much worsened (7).|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
21028|NCT01754493|Primary|Gastrointestinal Symptoms Rating Scale (GSRS)|Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
21029|NCT01754493|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.||units on a scale||Standard Deviation|Mean
21030|NCT01754480|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||percent of subjects|||Number
21031|NCT01754480|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:~At 2 minutes following start of study treatment~At 5 minutes following start of study treatment~At 7 minutes following start of study treatment~At 10 minutes following start of study treatment"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
21032|NCT01754480|Secondary|Time to Hemostasis|Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||minutes||95% Confidence Interval|Median
21033|NCT01754480|Secondary|Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 3 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
21034|NCT01754480|Primary|Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study||Percent of subjects achieving hemostasis|||Number
21035|NCT01753856|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the CC, EC and IC of the Iliac Crest|ES/BS is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption. Percentage = (ES/BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with ES/BS assessed in the CC, EC and IC of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
21036|NCT01753856|Secondary|Wall Thickness (W.Th) in the CC, EC and IC of the Iliac Crest|W.Th is the distance from the cement line to the marrow space of completed trabecular bone packets.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with a W. Th assessment in the CC, EC and IC of the iliac crest.||µm||Inter-Quartile Range|Median
21037|NCT01753856|Other Pre-specified|Average Length of DLs in the CC, EC, IC and PC of the Iliac Crest|The length of TET DLs is a measure of the extent of bone formation in each compartment within individual remodeling units and is measured in mm. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of DL length in the various compartments of the iliac crest.||mm||Standard Deviation|Mean
21038|NCT01753856|Secondary|Osteoid Thickness (O.Th) in the CC, EC and IC of the Iliac Crest|O.Th is a measure of the average thickness of osteoid seams.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an O.Th assessment in the CC, EC and IC of the iliac crest.||micrometers (mcm)||Inter-Quartile Range|Median
21039|NCT01753856|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the CC, EC and IC of the Iliac Crest|OS is the percentage of the entire trabecular BS that is covered by osteoid. Percentage = (OS / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the assessment of OS/BS in the CC, EC and IC of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
21040|NCT01753856|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the CC of the Iliac Crest|OV is the percentage of a given volume of bone tissue that consists of new unmineralized bone matrix (osteoid). Percentage = (OV/BV) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of OV/BV in the CC of the iliac crest.||percentage of BV||Inter-Quartile Range|Median
21041|NCT01753856|Secondary|Adjusted Apposition Rate (Aj.AR) in the CC, EC and IC of the Iliac Crest|Aj.AR is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were counted as missing.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Aj.AR assessments in the CC, EC and IC of the iliac crest.||µm/day||Inter-Quartile Range|Median
21042|NCT01753856|Secondary|Activation Frequency (Ac.f) in the CC, EC and IC of the Iliac Crest|Ac.f is the probability of new remodeling cycles initiated on the BS per year. Ac.f = (BFR/BS) / wall thickness. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were assigned a value of zero.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Ac.f assessments in the CC, EC and IC of the iliac crest.||new cycles per year||Inter-Quartile Range|Median
21043|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX)|CTX is a marker of bone turnover and is a measure of bone resorption. Percentage = (CTX value at specified time points - CTX value at baseline) / (CTX value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and serum CTX measured at baseline and the specified time points.||percentage change in CTX||Inter-Quartile Range|Median
21044|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Osteocalcin|Osteocalcin is a marker of bone turnover and a measure of osteoblast function. Percentage = (osteocalcin value at specified time points - osteocalcin value at baseline) / (osteocalcin value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum osteocalcin measured at baseline and the specified time points.||percentage change in osteocalcin||Inter-Quartile Range|Median
21045|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Procollagen Type I N-terminal Propeptide (P1NP)|P1NP is a marker of bone turnover and is a measure of bone formation. Percentage = (P1NP value at specified time points - P1NP value at baseline) / P1NP value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum P1NP measurements at baseline and the specified time points.||percentage change in P1NP||Inter-Quartile Range|Median
21046|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Intact Parathyroid Hormone (PTH)|PTH regulates calcium and phosphate metabolism in bone and kidney, and is typically measured in serum using the intact PTH assay. Percentage = (PTH value at specified time points - PTH value at baseline) / PTH value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum PTH assessed at baseline and the specified time points.||percentage change in PTH||Inter-Quartile Range|Median
21047|NCT01753856|Secondary|Percentage of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS or dLS/BS) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. Percentage = (Single or double TET labels / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label surface measured in the specified compartments of the iliac crest.||percentage of TET label||Inter-Quartile Range|Median
21048|NCT01753856|Secondary|Change From Baseline to 3 Months in Bone Formation Rate/Bone Surface (BFR/BS ) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BFR/BS is the volume of mineralized bone formed per unit surface of bone per unit of time [mm cubed per mm squared per year (mm³/mm²/year)]. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicates active bone formation, a SL or NL suggests suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 mcm/day or counted as missing. NL cases were assigned a value of zero.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with BFR/BS assessments in the specified compartments of the iliac crest.||mm³/mm²/year||Inter-Quartile Range|Median
21719|NCT01738698|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21049|NCT01753856|Secondary|Change From Baseline to 3 Months in Mineral Apposition Rate (MAR) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|MAR is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between 2 consecutive labels divided by the time interval. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation. SL cases were imputed to a value of 0.3 micrometers per day (µm/day) or counted as missing. NL cases were reported as missing.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an evaluation of MAR in the CC, EC, IC and PC of the iliac crest.||mcm/day||Inter-Quartile Range|Median
21050|NCT01753856|Secondary|Change From Baseline to 3 Months in Label Length Within Each Basic Multicellular Unit (BMU) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BMUs are local groups of osteoblasts and osteoclasts that act in concert to complete a single remodeling cycle. The label length is a measure of the extent of the mineralization front within each BMU in the CC, EC, IC and PC. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label lengths measured in the specified compartments of the iliac crest.||millimeters (mm)||Inter-Quartile Range|Median
21051|NCT01753856|Secondary|Percentage of Overfilled Remodeling Sites in the CC, EC and PC of the Iliac Crest Bone Biopsies|The percentage of overfilled remodeling sites in the CC, EC, and PC were defined as the percentage of observed remodeling units in which the second DL (TET) extended beyond the limits of the scalloped reversal line and into the adjacent, previously unresorbed surface of the bone. Percentage = (overfilled remodeling bone formation unit / total bone formation unit) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy evaluated for overfilled remodeling sites in the specified compartments of the iliac crest.||percentage of overfilled remodeling site||Inter-Quartile Range|Median
21052|NCT01753856|Secondary|Percentage of Mineralizing Surface With Remodeling-Based Formation and Modeling-Based Formation in the CC, EC and PC of the Iliac Crest Bone Biopsies|"The percentage of mineralizing surface where post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling based bone formation based on collagen fiber orientation and whether the underlying reversal line was scalloped or smooth.~Percentage = percentage remodeling- or modeling-based formation units * MS/BS"|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling- or modeling-based formation in the specified compartments of the iliac crest.||percentage of the total formation unit||Full Range|Median
21053|NCT01753856|Secondary|Percentage of Bone With Remodeling-Based and Modeling-Based Formations in the CC, EC and PC of the Iliac Crest Bone Biopsies|In this study, post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling-based bone formations which was determined by whether the underlying reversal line was scalloped or smooth and by the collagen fiber orientation. Percentage = (remodeling-based formation units or modeling-based formation units/ total bone formation units) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling-based or modeling-based formation in the specified compartments of the iliac crest.||percentage of the total formation unit||Inter-Quartile Range|Median
21054|NCT01753856|Secondary|MS/BS in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies 3 Months Post First Dose of Study Drug|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
21055|NCT01753856|Secondary|Change From Baseline to 3 Months in MS/BS in the Endocortical Compartment (EC), Intracortical Compartment (IC), and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
21085|NCT01753323|Secondary|Half-life (T1/2) - Part 1|T1/2 was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hr||Standard Deviation|Mean
21056|NCT01753856|Secondary|Number of Samples With Single or Double Tetracycline Labels, SL and DL, or No Tetracycline Labels in the CC, Endocortical Compartment (EC), Intracortical Compartment (IC) and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies||3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of the number of samples with specified labels in the various compartments of the iliac crest.||Samples|||Number
21057|NCT01753856|Primary|Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling, and calculated as the sum of the total extent of double label (DL) plus half the extent of single label (SL) divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or no label (NL) suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the CC of the iliac crest.||percentage of BS||Inter-Quartile Range|Median
21058|NCT01753557|Secondary|Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)||From baseline to 24 weeks after completion of drug administration|||participants|||Number
21059|NCT01753557|Secondary|Transition of Serum HCV RNA Levels||baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks|||log IU/mL||Inter-Quartile Range|Median
21060|NCT01753557|Secondary|Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration||36 weeks|||percentage of subjects achieving SVR12||95% Confidence Interval|Number
21061|NCT01753557|Secondary|Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)||24 weeks|||percentage of subjects achieving ETR||95% Confidence Interval|Number
21062|NCT01753557|Secondary|Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)||4 weeks|||percentage of subjects achieving RVR||95% Confidence Interval|Number
21063|NCT01753557|Primary|Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||48 weeks|||percentage of subjects achieving SVR||95% Confidence Interval|Number
21064|NCT01753518|Secondary|Cosmetic Outcome|The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is ‘1’, and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the ‘Overall Opinion’ of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar.|Measured at 6 week postoperative appointment|Not all patients or observers completed the scales. For the six items on the patient scale, N=44:52, but the overall opinion responding was N=43:51. For the observer scale the number responding was N=43:52 for vascularity, thickness, pliability, and surface area. N=42:52 for pigmentation and relief; N=42:50 for overall opinion.||units on a scale||Inter-Quartile Range|Mean
21065|NCT01753518|Primary|Skin Closure Time, All Resident Levels|Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat||minutes||Inter-Quartile Range|Median
21066|NCT01753518|Secondary|Surgeon Satisfaction (Per Procedure)|"Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision? How willing are you to recommend this skin closure (whether it was staples or suture) to a patient? How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section? There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with not at all,' not very, and no opinion being a negative response, and somewhat and extremely  being a positive response. Categories reported were negative, (including no opinion), and positive."|Immediately after the procedure (day 1)|A satisfaction survey wasn't completed for all of the procedures (103 per arm), so the reporting population is 91 for the suture arm, and 96 for the staple arm.||Surgeons reporting per category|||Number
21067|NCT01753518|Secondary|Patient Satisfaction|Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).|At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment|The reduction in the number of participants analyzed is due to not all participants completing the questionnaire, and all the questions. For appearance of incision, N=58:69. For willingness to use treatment again, N=59:68.||participants|||Number
21068|NCT01753518|Secondary|Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic|Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .|From day of procedure until end of hospital stay (typical dismissal on day 4)|||participants|||Number
21069|NCT01753518|Secondary|Postoperative Pain|Post-operative pain was assessed by pain medication use through chart review.|From day of procedure until end of hospital stay (typical dismissal on day 4)|||mg||Inter-Quartile Range|Median
21070|NCT01753518|Secondary|Participants With Postoperative Complications, by Type|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|Participants could have experienced more than one type of postoperative complication. Note: wound dehiscence is a surgical complication in which a wound ruptures along surgical suture. A seroma is a pocket of clear serous fluid. A hematoma is a localized swelling that is filled with blood caused by a break in the wall of a blood vessel.||participants|||Number
21071|NCT01753518|Secondary|Total Number of Participants With Postoperative Complications|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|The number of participants analyzed was reduced because some patients did not return for postpartum followup visits.||participants|||Number
21072|NCT01753518|Primary|Total Surgical Time, All Resident Levels|Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat||minutes||Inter-Quartile Range|Median
21073|NCT01753323|Secondary|Vz/F - Part 2|Vz/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||Liters||Standard Deviation|Mean
21074|NCT01753323|Secondary|CL/F - Part 2|CL/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who who vomited before 3 hours.||L/hr||Standard Deviation|Mean
21075|NCT01753323|Secondary|T1/2 - Part 2|T1/2 was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hours||Standard Deviation|Mean
21076|NCT01753323|Secondary|Tmax - Part 2|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hours||Full Range|Median
21077|NCT01753323|Secondary|Cmax - Part 2|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||ng/mL||Standard Deviation|Mean
21078|NCT01753323|Secondary|AUCinf - Part 2|AUCinf was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Deviation|Mean
21079|NCT01753323|Secondary|AUClast - Part 2|AUClast was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Deviation|Mean
21080|NCT01753323|Secondary|AUC0-48h - Part 2|AUC0-48h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Error|Mean
21081|NCT01753323|Secondary|AUC0-24h - Part 2|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.||hr*ng/mL||Standard Error|Mean
21082|NCT01753323|Secondary|Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1|Racc was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||ratio||Standard Deviation|Mean
21083|NCT01753323|Secondary|Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1|Vz/F was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||Liters||Standard Deviation|Mean
21084|NCT01753323|Secondary|Clearance (CL/F ) - Part 1|CL/F was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||L/hr||Standard Deviation|Mean
24075|NCT01700387|Secondary|Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life||12 Months||||||
21086|NCT01753323|Secondary|Area Under the Curve (AUC)Inf - Part 1|AUCinf was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hr*ng/mL||Standard Deviation|Mean
21087|NCT01753323|Secondary|Area Under the Curve (AUC)Last - Part 1|AUClast was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hr*ng/mL||Standard Error|Mean
21088|NCT01753323|Secondary|Time to Maximum Concentration (Tmax) - Part 1|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||hour||Full Range|Median
21089|NCT01753323|Secondary|Maximum Concentration (Cmax) - Part 1|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||ng/mL||Standard Error|Mean
21090|NCT01753323|Secondary|Area Under the Curve (AUC)0-24h - Part 1|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose was taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.||(hr*ng/mL)||Standard Deviation|Mean
21091|NCT01753323|Primary|28-day Cure Rate - Part 2|28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment.|Day 28|Intent-to-treat analysis set: the intent-to-treat analysis set included all randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
21092|NCT01753323|Primary|Time to Parasite Clearance|Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments.|Day 5|Pharmacodynamic (PD) analysis set for Cohorts 1, 2 and 3: The PD set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation, and 1 participant from Cohort 3, who was withdrawn on Day 1.||Hours||95% Confidence Interval|Median
21093|NCT01753115|Secondary|Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels|Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.|Two weeks after last vaccination|BioThrax immunogenicity population: received 3 vaccinations and had samples taken within the study-specified windows; had a valid immunogenicity result within 2 wks of the last vaccination; had no evidence of previous anthrax vaccination and received the correct BioThrax dose at all 3 times; received vaccine maintained at the proper temperature.||titer||95% Confidence Interval|Geometric Mean
21094|NCT01753115|Primary|Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)|Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).|Day 5 and Day 44 in Arm 1|Per protocol population: all subjects in arm 1 who received any dose of ciprofloxacin, had adequate PK data on Day 5 and Day 44, had received all three BioThrax doses, and who had no key protocol deviations (e.g., insufficient blood sample) that would be expected to affect the ciprofloxacin PK assessment.||ratio||90% Confidence Interval|Mean
21095|NCT01752907|Secondary|Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles|Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.|From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.|Full analysis set||percentage of participants|||Number
21096|NCT01752907|Secondary|Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting|"Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following:~Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE."|From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.|Full analysis set||percentage of participants|||Number
21097|NCT01752907|Secondary|Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting|Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.|From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks|Full analysis set||percentage of participants|||Number
21099|NCT01752907|Secondary|Mean Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation||units on a scale||Standard Error|Mean
21100|NCT01752907|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for each treatment cycle|Full analysis set with imputation||units on a scale||Standard Deviation|Mean
21101|NCT01752907|Primary|Maximum Patient-reported Bone Pain in Cycle 1|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1 to 5 during cycle 1.|Full analysis set with imputation||units on a scale||Standard Error|Mean
21102|NCT01752855|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Week 24 through Week 48|All participants who received at least one dose of study drug.||percentage of participants|||Number
21103|NCT01752855|Primary|Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|Data from participants receiving the new formulation of adalimumab in Study NCT01712178 were analyzed for 44 and 43 participants, respectively, at weeks 36 and 48. Data for the participants receiving the current formulation of adalimumab in Study NCT01712178 were analyzed for 43 participants at week 36 and 40 participants at week 48.||units on a scale||Standard Deviation|Mean
21104|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.||percentage of participants|||Number
21105|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.||percentage of participants|||Number
21106|NCT01752855|Primary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All available data were included. If a participant did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Deviation|Mean
21107|NCT01751867|Secondary|Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ C-30) Physical Functioning Scale|"EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning."|Baseline to end of treatment (approximately up to 2 years)|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. The missing data was imputed by the Last Observation Carried Forward (LOCF).||Scores on a scale||Standard Deviation|Mean
21108|NCT01751867|Secondary|Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.||From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
21109|NCT01751867|Secondary|Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)|Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration|Up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug.||Percentage of total days||Standard Deviation|Mean
24076|NCT01700387|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||13 Months||||||
21110|NCT01751867|Secondary|Transfusion Independence: Number of Participants Who Were Transfusion Independent|A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more.|Baseline; up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. Here, 'n' is the number of participants analyzed at specified time point.||Participants|||Number
21111|NCT01751867|Secondary|Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria|As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR).|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Participants who had baseline cytogenetic abnormality and had at least one post baseline cytogenetic assessments during study.||Percentage of Participants|||Number
21112|NCT01751867|Secondary|Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows <= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of >= 1.5 g/dL, platelet increase of >= 30,000/mL (starting with > 20,000/mL), neutrophils increase of >= 100% and > 500/μL.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.||Participants|||Number
21113|NCT01751867|Primary|Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population: Participants who received at least one dose of study medication.||Participants|||Number
21114|NCT01751802|Secondary|Safety Summary of Ecopipam in Patients With Lesch-Nyhan Disease: Total Number of Serious and Non-Serious Adverse Events Experienced During 3 Double-blind Crossover Periods|An additional objective of the study is to assess the safety of ecopipam in subjects with LND for up to 52 weeks. Total number of serious and non-serious adverse events experienced by participants while receiving ecopipam or placebo. For additional detail, see Adverse Events|Total duration over which participants recieved double-blind ecopipam or placebo, up to 6 or 12 weeks|All participants who received at least one dose||adverse events|||Number
21115|NCT01751802|Secondary|Effect of Ecopipam Withdrawal and Maintenance|The secondary objectives of this study are to assess the effect of withdrawal and maintenance of ecopipam's effects in subjects with LND. Measured by the number of participants whose score changes significantly from baseline on ecopipam or placebo|Baseline, 6 weeks, 12 weeks, 18 weeks|0 participants analyzed because data are not reliable|||||
21116|NCT01751802|Primary|Behavior Problems Inventory - Self-Injurious Behavior Subscale|The primary endpoint is the BPI (SIB subscales - total for frequency and severity) as assessed by the caregiver. BPI Self-Injurious Behavior Subscale ranges from 0 to 45, with higher scores indicating more self-injurious behavior.|Baseline, end of period 1 (6 weeks), end of period 2 (12 weeks), end of period 3 (18 weeks),|All participants who completed the BPI-Self Injurious Behavior survey for 3 or more time points||scores on a scale||Standard Deviation|Mean
21117|NCT01751308|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time (in months) from the date of first dose administration until the date of death (from any cause). If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive and the study cut-off date. The analysis was performed by Kaplan-Meier method.|Baseline up to death or study cut-off (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.||months||95% Confidence Interval|Median
21118|NCT01751308|Secondary|Phase 2: Progression Free Survival (PFS)|The PFS was defined as the time (in months) from the date of first dose administration until the date of first documented PD or death (from any cause), whichever came first. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. PD as per RANO criteria was defined as ≥25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) plus any increase in tumor cross-sectional area (or tumor volume). The analysis was performed by Kaplan-Meier method.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.||months||95% Confidence Interval|Median
21119|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.||ng/mL||Standard Deviation|Mean
21233|NCT01748071|Primary|Mean Value of Narco-trend Index|According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.|10 minutes after the procedure|||units on a scale||Standard Deviation|Mean
21120|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.||L/m^2||Standard Deviation|Mean
21121|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.||L/h/m^2||Standard Deviation|Mean
21122|NCT01751308|Secondary|Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve|Blood samples for PK parameters were collected at 5 minutes before end of infusion (EOI), 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|PK population (for both Phase 1 and Phase 2 parts of the study) included all participants who received treatment on Day 1 of Cycle 1 and had at least one post-dose PK sample. Number of participants analyzed=participants with available data for this endpoint.||ng.h/mL||Standard Deviation|Mean
21123|NCT01751308|Secondary|Phase 1: Number of Participants With Objective Response|OR in participants was defined as the participants with a CR or PR after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1 and RANO criteria for CNS tumors. For solid tumors, as per RECIST 1.1, CR defined as disappearance of all target and non-target lesions (any pathological lymph nodes, must had reduction in short axis to <10 mm); PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For CNS tumors, as per RANO criteria, CR defined as disappearance of all target and non-target lesions; PR defined as a ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.||participants|||Number
21124|NCT01751308|Secondary|Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. Treatment emergent adverse events (TEAEs) were defined as AEs that developed or worsened in grade or became serious during the on-treatment period which was defined as the period from the time of first dose of cabazitaxel until 30 days following the last administration of cabazitaxel.|Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2)|Analysis was performed on safety population (AT population).||participants|||Number
21125|NCT01751308|Primary|Phase 2: Duration of Response (DOR)|DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. If progression or death was not observed, participant was censored at the date of participant’s last progression-free tumor assessment prior to study cut-off date. PD as per RANO criteria was defined as ≥ 25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) plus any increase in tumor cross-sectional area (or tumor volume).|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Due to no objective responses in Stage 1 of Phase 2, the analysis of duration of response was not performed.Hence, the data is not reported.|||||
21126|NCT01751308|Primary|Phase 2: Percentage of Participants With Objective Response (OR)|OR in participants was defined as the participants with a Complete Response (CR) or Partial Response (PR) after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks. CR and PR were based on modified response assessment in neuro-oncology (RANO) criteria for participants with CNS tumors. CR was defined as disappearance of all target lesions. PR was defined as ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to the baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Efficacy evaluable population was subset of AT population with measurable disease with a baseline and at least one post-baseline tumor evaluation.Number of participants analyzed=participants with available data for this endpoint.||percentage of participants|||Number
21127|NCT01751308|Primary|Phase 1: Maximum Tolerated Dose of Cabazitaxel|MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases<10* upper limit of normal of ≤7 days, re-treatment delay of>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Cycle 1 (21 days)|DLT evaluable population defined as a subset of participants in the Phase 1 part of the study from the AT population who received the first dose of cabazitaxel and had sufficient safety evaluations or experienced a DLT during Cycle 1.||mg/m^2|||Number
21150|NCT01751087|Secondary|Initial Cervical Dilation|Measured at the time of procedure (immediately before the start of D&E)|participants were assessed during cervical dilation process, average time of 1 minute|Arm 1: 1 subject excluded [withdrawn/no intervention]. Arm 2: 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3: 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing]. Additionally missing data for one more subject in Arm 2.||centimeters||Standard Deviation|Mean
21128|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores|Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on ITT population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
21129|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores|Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
21130|NCT01751178|Secondary|Gingival Index|The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
21131|NCT01751178|Primary|Gingival Severity Index (GSI) Based on the Gingival Index (GI)|"Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and,~GSI = 0 if GI is 0 or 1 (no bleeding)~GSI = 1 if GI is 1 or 2 (bleeding)"|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Mean
21132|NCT01751113|Secondary|Use of Rescue Medication (Number of Occasions Per 24-hour Period) as Recorded in the Daily Record Card at Day 28 of Each Treatment Period|Participants were given daily record cards for daily completion during the run-in, washout and treatment periods. Each morning, participants recorded the number of occasions in the last 24 hours when they had used their rescue medication (salbutamol) for symptomatic relief of COPD symptoms.|Day 28 of each treatment period (up to 35 days)|mITT Population. Only those participants available who used rescue medication at the specified periods were analyzed (represented by n=X, X, X in the category titles).||Number of occasions||Standard Deviation|Mean
21133|NCT01751113|Secondary|Post-dose FEV1/FVC Ratio (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements.|Day 28 of each treatment period (up to 35 days)|mITT Population||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
21134|NCT01751113|Secondary|Post-dose FEV1, FVC, IC, RV, TLC and TGV (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the RV. RV is defined as the volume of air remaining in the lungs after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration.|Day 28 of each treatment period (up to 35 days)|mITT Population||Liters (L)||Standard Error|Least Squares Mean
21135|NCT01751113|Secondary|Trough sGaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||1/kPa*s||Standard Error|Geometric Mean
21136|NCT01751113|Secondary|Trough sRaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||kPa*s||Standard Error|Geometric Mean
21137|NCT01751113|Secondary|Trough FEV1/FVC Ratio, at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
21234|NCT01748071|Primary|Mean Pressure Pain Threshold|According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics|10 minutes after the procedure|||kg/cm2||Standard Deviation|Mean
21138|NCT01751113|Secondary|Trough Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC), RV, TLC, and TGV at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the residual volume (RV). RV is defined as the volume of air remaining in the lungs. after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population||Liters (L)||Standard Error|Least Squares Mean
21139|NCT01751113|Secondary|Post-dose sRaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. A natural logarithmic transformation was applied and the data was analysed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sRaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population||kPa*s||Standard Error|Geometric Mean
21140|NCT01751113|Secondary|Post-dose sGaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaws. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sGaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population||1/kPa*s||Standard Error|Geometric Mean
21141|NCT01751113|Secondary|AUC (0-4hr) Specific Airway Resistance (sRaw) After the Morning Dose of Each Study Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sRaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the LS means.|Day 28 of each treatment period (up to 35 days)|mITT Population||kPa*s||Standard Error|Geometric Mean
21142|NCT01751113|Primary|Area Under the Curve Calculated From 0 to 4 Hours (AUC[0-4hr]) Specific Conductance (sGaw) After the Morning Dose of Study Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sGaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the Least Square (LS) means.|Day 28 of each treatment period (up to 35 days)|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study medication and completed at least two treatment periods and also had a Baseline and at least one on treatment sGaw assessment measure.||1/kilopascal*second (1/kPa*s)||Standard Error|Geometric Mean
21143|NCT01751087|Secondary|Physician Satisfaction With Cervical Preparation|Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.|physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes|"Data on whether the physician was satisfied with the cervical preparation is available for all participants except:~Arm 1: 1 participant withdrawn with no intervention; Arm 2: 1 participant who didn't have a D&E (expelled), Arm 3: 1 participant withdrawn with no intervention and one with missing data."||participants||95% Confidence Interval|Number
21144|NCT01751087|Secondary|Patient Satisfaction With Cervical Prep|Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.|patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days|||participants|||Number
21145|NCT01751087|Secondary|Chills (Any) After Day 2 Medication Administration|chills (any) after Day 2 medication administration|assessed immediately after administration of day 2 medication|||participants||95% Confidence Interval|Number
21146|NCT01751087|Secondary|Complications From Procedure|Patient having any complication, including hospitalizations transfusions additional unplanned procedures|assessed immediately after completion of D&E and at 1 week and 1 month post-procedure|||participants|||Number
21147|NCT01751087|Secondary|Ease of Mechanical Dilation|Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Number of participants in each arm who required additional mechanical dilation||participants|||Number
21148|NCT01751087|Secondary|Need for Mechanical Dilation|Assessed on Day of procedure. Assessed immediately after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D&E. Arm 3: one subject withdrawn/no intervention||participants||95% Confidence Interval|Number
21149|NCT01751087|Secondary|Ability to Complete the D&E on the First Attempt|Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.|participants were assessed for the duration of the procedure, an average of 6 minutes|||participants|||Number
21151|NCT01751087|Primary|Operative Time|The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1 (dilators-alone): 1 subject excluded [withdrawn/no intervention]. Arm 2 (dilators + misoprostol): 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3 (dilators + mifepristone): 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing].||minutes||Standard Deviation|Mean
21152|NCT01751022|Secondary|Complication Rate for Individual Attain Performa Lead Related Events||6 month post-Implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||percentage of participants||95% Confidence Interval|Number
21153|NCT01751022|Secondary|Pacing Impedance at the Final Programmed Pacing Polarity|"Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.~Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms)."|6 month post-implant|Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.||Ohms||Standard Deviation|Mean
21154|NCT01751022|Secondary|Implant Related Times Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||minutes||Standard Deviation|Mean
21155|NCT01751022|Secondary|Pacing Capture Thresholds at the Final Programmed Pacing Polarity||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.||Volts||Standard Deviation|Mean
21156|NCT01751022|Secondary|Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||percentage of participants|||Number
21157|NCT01751022|Secondary|Percentage of Subjects With Successful Implant Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||percentage of participants||95% Confidence Interval|Number
21158|NCT01751022|Secondary|Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities|Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.|6 months post-implant|Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.||percentage of participants|||Number
21159|NCT01751022|Primary|LV Pacing Capture Thresholds Per Attain Performa Lead Model||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.||percentage of participants||97.5% Confidence Interval|Mean
21160|NCT01751022|Primary|Lead Complication-free Rate at 6 Months|"The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:~- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).~- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.~The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models."|Implant to 6 months post-implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.||Survival Probability (%)||97.5% Confidence Interval|Number
21161|NCT01750840|Secondary|Quality of Life Assessment|Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed.|The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.|No quality of life data was collected for any of the patients enrolled in the study. As such, no analysis was performed on quality of life measures.|||||
21212|NCT01749631|Secondary|Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane|The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.|From start of induction to completion of intubation (up to 30 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.||percentage of participants|||Number
21162|NCT01750840|Primary|Radiographic Assessment of Healing|Bone healing was assessed on x-rays and/or CT scan.|The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.|All patients, with one nonunion fracture each, were treated with the Biomet EBI Bone Healing System. Four patients had final healing outcomes reported (two patients with a 5th metatarsal nonunion, one patient with a tibial nonunion and one patient with a fibula nonunion) and all healed in an average time of 2.5 months.||percentage of healed fractures|Participants||Number
21163|NCT01750684|Secondary|Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data|Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC).|baseline, prior to and up to 5 hours following last infusion||||||
21164|NCT01750684|Primary|Safety and Tolerability Assessed by Comparing Adverse Event (AE) Data for Patients Administered a Regimen of 6 Intravenous Doses of AC105 Over 30 Hours Compared With Patients Administered the Same Regimen of Placebo.|Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion.|up to 6 months|Safety Population||participants|||Number
21165|NCT01750502|Other Pre-specified|Comparison of MIF-173G/C Alleles of CHD Patients and Controls.||Before surgery|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.||alleles|||Number
21166|NCT01750502|Other Pre-specified|Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.||Before surgery|||participants|||Number
21167|NCT01750502|Secondary|Comparison the Change of MIF Before and After Percutaneous Coronary Intervention （PCI） at the Patients Who Are Acute Coronary Syndromes and Stable Ischemic Heart Disease|Percutaneous Coronary Intervention are extracted 3 times including before surgery 5 minutes , 5 minutes after the opening of the balloon and after surgery 5 minutes ,and detection MIF concentration .|3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes|Coronary-artery-disease Group does not include myocardial infarction, 21 patients were acute myocardial infarction participants.||MIF Concentration , ug/L||Standard Deviation|Mean
21168|NCT01750502|Primary|Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration|Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.|Before surgery 5 minutes|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.||MIF Concentration,ug/L||Standard Deviation|Median
21169|NCT01750398|Secondary|Change in Waist Circumference||Bseline, 6 months and 9 months.|||cm||Standard Deviation|Mean
21170|NCT01750398|Secondary|Change in Weight|Change in weight is measured from baseline to 6 months (i.e. following ADT lead in) and from 6 months to 9 months (i.e. from post-ADT to the end of cycle 1 of BAT).|Baseline, 6 months and 9 months.|||kg||Standard Deviation|Mean
21171|NCT01750398|Secondary|Quality of Life Survey|"To measure quality of life through the RAND-SF36 (short-form 36 questionnaire) Quality of Life Survey, the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P), the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS) and a visual pain scale. Note that for all scales, higher scores indicate better quality of life/function, with the exception being the visual pain scale, where a higher score indicates more pain.~RAND-SF36: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Range is from 0 to 100.~FACT-P: A tool used for assessing the health-related quality of life in men with prostate cancer. Range is from 0 to 156.~IIEF: Is a measure of erectile function. Range is from 5 to 25. IPSS: A tool used to measure symptoms related to prostatic disease. Range is from 0 to 35.~Visual pain scale: A tool used to track pain level. Range is from 0 to 10."|3 months|||units on a scale||Full Range|Median
21172|NCT01750398|Secondary|Change in C-telopeptides|Change in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months)|6 months and 9 months|||pg/ml||Standard Deviation|Mean
21173|NCT01750398|Secondary|Complete PSA Response|To evaluate the number of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) at the end of the study|18 months|||participants|||Number
21174|NCT01750398|Secondary|Radiographic or Clinical Progression|To evaluate the number of men treated per the bipolar androgen therapy phase of the trial who developed radiographic or clinical progression. Radiographic progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was defined as new symptoms that can be attributed to progressive prostate cancer (e.g. new/worsening pain, urinary obstruction, cord compression, bone fractures).|18 months|||participants|||Number
21175|NCT01750398|Primary|Patients With PSA <4 ng/mL at the End of the Study|To determine the clinical effects of BAT in men with recurrent prostate cancer as first line therapy. This will be accomplished by assessing the number of patients achieving a PSA <4 ng/ml at the end of the trial.|18 months|||participants||90% Confidence Interval|Number
21176|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 7 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 7 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|7 months|||units on a scale|||Number
21229|NCT01748227|Primary|Pain/Enjoyment of Life/General Activity|3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.|Change from baseline to 4 month assessment|||units on a scale||Standard Deviation|Mean
21177|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 6 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 6 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|6 months|||units on a scale|||Number
21178|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 3 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 3 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|3 months|||units on a scale||Full Range|Mean
21179|NCT01750346|Secondary|The Blepharospasm Disability Scale at 2 Months|The Blepharospasm Disability Scale (BDS) was measured at 2 months from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|2 months|||units on a scale||Full Range|Mean
21180|NCT01750346|Secondary|The Blepharospasm Disability Scale at 1 Month|The Blepharospasm Disability Scale (BDS) was measured at 1 month from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|1 month|||units on a scale||Full Range|Mean
21181|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 1 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 1 month from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|1 month|||units on a scale||Full Range|Mean
21182|NCT01750346|Primary|The Jankovic Blepharospasm Rating Scale at 2 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) at 2 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|2 months|One participant in the 0.05% AH-8 arm was withdrawn due to development of blepharitis.||units on a scale||Full Range|Mean
21183|NCT01750294|Primary|Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks||Baseline and 12 weeks after intervention|Intention to treat analysis (includes completers and non-completers)||mmHg||Standard Deviation|Mean
21184|NCT01750255|Secondary|Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy|Quantify the preventable causes of problems of effectiveness and safety of pharmacotherapy. Quantify the process problems like a drug availability problems, problems in prescribing, dispensing problems, administration and use, quality problem.[Time Frame: At 3, 6, 9 and 12 months]|1 year||||||
21185|NCT01750255|Secondary|Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy|Necessity problems of pharmacotherapy are related to the following two questions: 1) The patient has a health problem associated with not receiving a medication you need? 2) The patient has a health problem associated with getting a medicine that does not need. The safety of the pharmacotherapy will be measured by the safety profile of drugs and serum concentrations of drugs. The effectiveness of the pharmacotherapy will be measured by Hamilton Rating Scale for Depression, Clinical Global Impressions (CGI), Young Mania Rating Scale.|1 year||||||
21186|NCT01750255|Secondary|Depression|To assess depressive symptoms, will be used the the Hamilton Depression Rating Scale. [Time Frame: At 3, 6, 9 and 12 months]using hamilton depression scale|1 year||||||
21187|NCT01750255|Secondary|Mania||1 year||||||
21188|NCT01750255|Secondary|Clinical Global Impression for Bipolar Modified, CGI-BP-M.|The modified version of the Clinical Global Impression for Bipolar Disorder (CGI-BP-M) a condensed version of the CGI-BP, which is also an adaptation of the CGI for bipolar patients. The CGI-BP-M, is a scale for the assessment of manic, hypomanic, depressive or mixed symptoms, and long-term outcome of bipolar disorder. Assesses the current gravity, the short and long term of the disease course. It consists of three subscales, composed of a single item, evaluating the severity of the acute symptoms of depression, mania and disease in general (refers to the longitudinal disease severity). It has a Likert intensity scale of 7 degrees of freedom ( 1 normal, 7 very severe).|1 year|||Clinical Global Impression||Standard Deviation|Mean
21189|NCT01750255|Secondary|Adherence to Treatment|Total percentage of adherence by treatment group|1 year|Total percentage of adherence by treatment group||Medication adherence percentage|||Number
21230|NCT01748071|Secondary|Mean Respiratory Frequency|According to the measurement of respiratory frequency after intravenous injection of opioid analgesics|10 minutes after the procedure|||breaths per minute||Standard Deviation|Mean
21190|NCT01750255|Secondary|Quality of Life|The Short Form-36 Health Survey (SF-36): It is a questionnaire to measure quality of life, exploring the physical and mental health. Contains 36 topics that explore 8 dimensions of health: physical function; social function; limitations of the role: physical problems; limitations of the role: emotional problems; mental health; vitality; pain and general health perception. Each of the 8 dimensions of the SF-36 scores range between 0 and 100 values. 100 being a result indicating optimal health and 0 would reflect in a very bad state of health. The questionnaire allows the calculation of 2 scores summary, physical component summary (PCS) and mental (MCS), by combining each dimension scores|1 year|||Mental health summary score||Standard Deviation|Mean
21191|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits||1 year|||Outpatient-unscheduled visits|||Number
21192|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations||1 year|||Emergency Service Consultations|||Number
21193|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations||1 year|||Hospitalizations|||Number
21194|NCT01750242|Secondary|Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores|The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108.|Change from baseline to 18 months|Per protocol||units on a scale||Standard Deviation|Mean
21195|NCT01750242|Primary|To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap|The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.|18 months|Per Protocol||percentage of leads|Participants||Number
21196|NCT01750086|Primary|Bone Turnover Marker (Blood Sample)|The primary outcome was the between-group difference in the teriparatide-induced change in CTX from baseline to week 8.|8 weeks|||percentage of change in CTX||Standard Deviation|Mean
21197|NCT01749982|Primary|Change in Urinary % Dimethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)|||percentage of total urinary arsenic||Full Range|Median
21198|NCT01749982|Primary|Change in Urinary % Inorganic Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)|||percentage of total urinary arsenic||Full Range|Median
21199|NCT01749982|Primary|Change in Urinary % Monomethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)|||percentage of total urinary arsenic||Full Range|Median
21200|NCT01749956|Secondary|The Number of Participants Who Experienced Serious or Non-Serious Adverse Events as a Measure of Safety.|Adverse events and serious adverse events (AEs and SAEs) were graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0. Specific AE and SAE terms are provided in the Adverse Event module.|weekly for 6 weeks pre-op then every 2 weeks post-op, approximately 36 weeks|All patients who received at least one dose of protocol treatment.||participants|||Number
21201|NCT01749956|Secondary|Disease Free Survival Probability at 6 and 12 Months|The probability of disease free survival at 6 and 12 months after initiating protocol treatment.|Up to 1 year|||probability||95% Confidence Interval|Number
21202|NCT01749956|Secondary|Disease-Free Survival||Patients without evidence of progression will be followed every 3 months (±1 month) from date of last dose of study drug during Years 1-2, every 6 months during Years 3-4, and annually thereafter or until disease progression, estimated 5 years.|All evaluable patients.||percentage of participants||95% Confidence Interval|Median
21203|NCT01749956|Secondary|Sphincter Preservation Rate|The percentage of patients who had Low Anterior Resection during surgery..|Between days 57 and 98 after preoperative chemotherapy.|||percentage of patients|||Number
21204|NCT01749956|Secondary|Overall Survival Probability at 6 and 12 Months|The probability of overall survival at 6 months and 12 months from date of first protocol treatment until date of death.|up to 1 year|||probability||95% Confidence Interval|Number
21205|NCT01749956|Secondary|Overall Survival|Measured from date of first protocol treatment until date of death.|Every 3 months (±1 month) following documented progression, up to 5 years or death, whichever comes first.|||participants||95% Confidence Interval|Median
21206|NCT01749956|Primary|Pathologic Complete Response Rate|The Pathologic Complete Response (pCR) Rate is defined as the number of pathologic complete responders among all patients evaluable for response, including evaluable patients who did not proceed to surgery. A pCR is defined as the absence of any residual abnormality detected in a pathological specimen.|Between days 57 and 98 after preoperative chemotherapy|All patients enrolled in the trial who were evaluable for pathologic response. Four patients were not evaluable for response.||participants|||Number
21207|NCT01748799|Secondary|Cannabis Withdrawal|Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).|8 weeks|Only 9 of the 16 participants recruited completed the whole experimental sequence (participants were assigned to 1 of 8 different experimental sequences in a randomized order).||units on a scale||Standard Deviation|Mean
21208|NCT01748799|Secondary|Tolerability of Sativex in Persons That Are Cannabis Dependent|To assess what number of participants might withdrew due non-tolerability of Sativex|8 weeks|Data from 16 participants enrolled in the study was analyzed, none of the participants withdrew due non-tolerability of Sativex||participants|||Number
21209|NCT01748799|Primary|Feasibility|Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.|12 months|16 participants were enrolled in the study, 9 participants completed the whole (randomly assigned) experimental sequence||participants|||Number
21210|NCT01748760|Primary|Number of Participants Who Repoorted a Suicide Event|A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.|6 months|||participants|||Number
21211|NCT01749631|Secondary|Mean Number of Intubation Attempts||Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||number of attempts||Standard Error|Mean
21213|NCT01749631|Secondary|Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure|The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.|Start of intubation to completion of intubation (up to 15 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.||percentage of participants|||Number
21214|NCT01749631|Secondary|Mean Duration of Intubation Procedure (in Minutes)|The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]).|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||minutes||Standard Error|Mean
21215|NCT01749631|Secondary|Percentage of Participants With Mallampati Score III and IV|Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.|Screening|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||percentage of participants|||Number
21216|NCT01749631|Secondary|Mean Duration of Induction (in Seconds)|The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.|From start of induction up to 15 minutes|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||seconds||Standard Error|Mean
21217|NCT01749631|Primary|Percentage of Participants With Successful Intubation (Clinical Success)|Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.||percentage of participants|||Number
21218|NCT01749501|Secondary|Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.||24 hours after intubation procedure|||minutes||Standard Deviation|Mean
21219|NCT01749501|Primary|Present the Percentage of Participants With an Excellent Ease of Intubation Rating|"percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"|24 hours after intubation period|||% reported as excellent|||Number
21220|NCT01749410|Primary|Change From Baseline in the Number of Headache Days|The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.|Treatment Cycle 7 (approximately 1.5 years)|All subjects who satisfied the inclusion and exclusion criteria||Days||Standard Deviation|Mean
21221|NCT01748955|Secondary|Change in Suicidal Ideation (SSI Score)|Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts|Measured at Baseline and Week 8|||units on a scale||Standard Deviation|Mean
21222|NCT01748955|Primary|Percent Change in Contrast of Parameter Estimates (COPE)|"% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task.~Task conditions are:~Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents"|Measured at Baseline (pre-treatment) and Week 8 (post-treatment)|Major depressive disorder with suicidal thoughts or past suicide attempt.||Percentage change||Full Range|Mean
21223|NCT01748916|Primary|Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato|The primary goal of this research is to investigate whether papaya can deliver increased quantities of carotenoids when compared to carrot and tomato. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) over time will be determined to quantify absorption, after subjects consume a meal containing papaya, carrot or tomato.|8 post-prandial blood samples over 9.5 hours|||nmol*h/L||Inter-Quartile Range|Median
21224|NCT01748890|Primary|The Number of Core Biopsies in These Targeted Regions|From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.|Participants will be followed until prostatectomy pathology is available (average 1 week)|insufficient recruitment for analysis|||||
21225|NCT01748227|Secondary|Pain Centrality Scale|Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.|4 month assessment|||units on a scale||Standard Deviation|Mean
21226|NCT01748227|Secondary|Patient Reported Outcome Measurement System (PROMIS)|Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.|Change from baseline to 4 month assessment|||units on a scale||Standard Deviation|Mean
21227|NCT01748227|Secondary|Multidimensional Perceived Social Support Scale (MPSS).|12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).|Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance|||units on a scale||Standard Deviation|Mean
21228|NCT01748227|Secondary|Pain Catastrophizing Scale|Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.|Baseline and 4 month assessment (final assessment)|||units on a scale||Standard Deviation|Mean
21235|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17|OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. All participants in the 10 mcg device-10 mcg dose and 20 mcg device-20 mcg dose (total 12 participants) are stated as not applicable as they tested the full dose."||participants|||Number
21236|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16|OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21237|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b|OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21238|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13|"OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A Yes response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21239|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12|"OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21240|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11|"OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21241|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10|OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21242|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9|"OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21243|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8|OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21244|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7|"OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21245|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6|"OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
21246|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5|OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
21247|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4|"OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
21248|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3|"OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."||participants|||Number
21249|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2|OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant in the 10 mcg device-2.5 mcg dose was excluded as failure at Q1 did not involve mechanical failure or defect.||participants|||Number
21250|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1|"OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A No answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components."|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.||participants|||Number
21251|NCT01747928|Secondary|Time Required to Perform Segments 1 to 5|Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. n=number of participants analyzed for that segment.||seconds||Standard Deviation|Mean
21252|NCT01747928|Secondary|Number of Participants Providing Responses to Any Question on the PAT|Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
21253|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?|Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
21254|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Most Difficult Step?|Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
21255|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?|Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
21256|NCT01747928|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?|Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||participants|||Number
21257|NCT01747928|Post-Hoc|DSSR Based on the Primary Objective|This post-hoc DSSR was calculated in order to provide a DSSR that recognized as a “failure” only those participants who were unable to successfully complete the overall injection task, regardless of whether they met with difficulties at any step.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.||percentage of participants||95% Confidence Interval|Number
21258|NCT01747928|Primary|Delivery System Success Rate (DSSR)|"DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/hands on demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption."|Day 1|The full analysis set (FAS) consisted of all protocol defined valid attempts to perform the study procedure as documented in the Observer Assessment Tool (OAT).||percentage of participants||95% Confidence Interval|Number
21259|NCT01747811|Other Pre-specified|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks|The Beck Depression Inventory (BDI-II) is a self report scale utilized for measuring the severity of depression. Scores can range from 0-63 (0 meaning minimal depressive symptoms, and 63 being severe depressive symptoms). Participants are given this on baseline and post treatment.|Change from baseline at 6 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
21260|NCT01747811|Secondary|Performance on Neuropsychological Assessment|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological assessment that measures different facets of memory including the following: immediate memory, visuospatial/constructional, language, attention, and delayed memory. This is given to all participants on both pre and post treatment visits. The total range for this scale is 40-160. Lower values represent a worse outcome, and higher values represent an improved outcome.|Change from baseline at 6 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
21261|NCT01747811|Secondary|Actigraphy-measured Sleep Quality|Actigraphy is an objective measure that determines sleep vs. wake. It is a watch with an accelerometer worn on the wrist. Sleep quality is determined by the amount of time in bed divided by the amount of time sleeping (in minutes).|Change from baseline at 6 weeks (post-treatment)|We collected usable actigraphy from 29 participants. The 7 remaining participants had unusable actigraphy data.||minutes||Standard Deviation|Mean
21262|NCT01747811|Secondary|Score on Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index is a self report measure of sleep quality. The overall score takes into account many different facets of sleep, such as sleep quality, sleep latency, sleep duration, sleep disturbances, etc. The scores range from 0-21, and any score that is equal to or greater than 5 is indicative of poor sleep quality.|Change from baseline at 6 weeks (post-treatment)|||units on a scale||Standard Deviation|Mean
21263|NCT01747811|Secondary|Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task|Change from baseline in left prefrontal cortical response during a multi source interference task at six weeks. Methods utilized to assess activity in the left prefrontal cortex/inferior frontal operculum included a regions of interest analysis.|Change from baseline performance at 6 weeks (post-treatment)|A total of 22 participants had useable data, 4 participants were excluded due to movement in the images.||Percent Signal Change||Standard Deviation|Mean
21264|NCT01747811|Primary|Performance on Multiple Sleep Latency Test (MSLT)|The MSLT is a objective measure of sleepiness. Participants will take a brief nap 3 times during the 1st and second visit. The period of time between wake and sleep onset will be utilized as an objective measure of sleepiness (in minutes). A mean value will be calculated for the entirety of the pre-treatment napping periods and for the post treatment visits.|Change from baseline performance at 6 weeks (post-treatment)|||minutes||Standard Deviation|Mean
21265|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months , including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||percentage of participants|||Number
21266|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||percentage of participants|||Number
21267|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||percentage of participants|||Number
21268|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||visits at home||Standard Deviation|Mean
21269|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||office visits||Standard Deviation|Mean
21270|NCT01747655|Secondary|Parkinson’s Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked to state how often they had encountered certain problems over the past four weeks using the following rating scale: Never (0), occasionally (1), sometimes (2), often (3), always or cannot do at all (4). The PDQ-8 summary index was derived as the sum of the single items divided by 32. Scores range from 0 to 100. A higher summary index score indicates a higher impairment of quality of life. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21271|NCT01747655|Secondary|Non-Motor Symptoms Assessment Scale for Parkinson’s Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Non-motor symptoms assessed over the previous month were scored with respect to severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) and with respect to frequency (1 = rarely, 2 = often, 3 = frequent, 4 = very frequent). The total NMSS score ranges from 0 to 360 with higher values indicating greater impairment and was calculated as the sum of all individual score values. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21282|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
21272|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|The UPDRS III questionnaire consists of 14 questions on motor examinations rated from 0 (absent/normal) to 4 (extreme impairment). Questions 20–26 are multi-part questions in that they are evaluated separately for multiple body parts (for example, for the left and right hand). Counting each of these assessments leads to a total of 27 answers. The UPDRS III score ranges from 0 to 108 with higher values indicating greater impairment and was calculated as the sum of the 27 answers provided to the 14 questions. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21273|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21274|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21275|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21276|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21277|NCT01747655|Secondary|Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study|The primary reasons for stopping treatment with Duodopa or for discontinuing the study.|12 months|Participants in the MAS who stopped treatment with Duodopa or discontinued from study.||participants|||Number
21278|NCT01747655|Secondary|Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment|The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube.|14 days|MAS population||percentage of participants|||Number
21279|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21280|NCT01747655|Primary|Unified Parkinson’s Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data."|Baseline (Week 0) and 12 months after hospital discharge|MAS population||units on a scale||Standard Deviation|Mean
21281|NCT01747629|Secondary|Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||hour||Standard Deviation|Mean
21320|NCT01746511|Secondary|Rate of Decline in Bilirubin Levels (mg/dL/hr)|Absolute change over time from peak to first discontinuation of phototherapy lights|from time of enrollment to time of discharge, for a maximum of 10 weeks|||mg/dL/hr||Standard Deviation|Mean
21283|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 1|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
21284|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).~AUC0-t on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
21285|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).~AUC0-6 on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg*hr/mL||Standard Deviation|Mean
21286|NCT01747629|Secondary|Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||hour||Full Range|Median
21287|NCT01747629|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.||pg/mL||Standard Deviation|Mean
21288|NCT01747629|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).~Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:~Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Days 8 and 85|Safety analysis set||participants|||Number
21289|NCT01747629|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint. HEENT = head, eyes, ears, nose, throat.|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized.||participants|||Number
21290|NCT01747629|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 93|Safety analysis set||participants|||Number
21291|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
21292|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
21293|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set||L*hr||95% Confidence Interval|Mean
21294|NCT01747629|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set included all participants in the intent-to-treat population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.||L*hr||Standard Error|Mean
21295|NCT01747343|Other Pre-specified|Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children||2 months minus baseline|||Self-initiations||Standard Deviation|Mean
21296|NCT01747343|Secondary|Change in the Mean Percentage of Appropriate Eliminations Across Children||2 months minus baseline|||Percentage of opportunities||Standard Deviation|Mean
21297|NCT01747343|Primary|Change in the Mean Number of Accidents Across Children||2 months minus baseline|||Accidents||Standard Deviation|Mean
21298|NCT01747330|Secondary|Number of Participants With Clinical Relevant Safety Laboratory Values|(hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)|3 months|Full Analysis subject sample||participants|||Number
21299|NCT01747330|Secondary|Number of Participants With Findings During Physical Examination|A physical examination was conducted by the physician. All abnormal findings were recorded as medical histories if present prior to start of study drug or as AEs otherwise. There was no separate documentation of physical examination findings in this study.|3 months|Full Analysis subject sample||participants|||Number
21300|NCT01747330|Secondary|Pulse|Change from Baseline at Day 84|3 months|||bpm||Standard Deviation|Mean
21301|NCT01747330|Secondary|Number of Subjects With Adverse Events||4 months|Full Analysis subject sample||participants|||Number
21302|NCT01747330|Primary|Subject's Acceptance of Treatment|Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.|3 months|Full Analysis subject sample||percentage of participants|||Number
21303|NCT01747330|Primary|Stool Consistency|Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery|3 months|Full Analysis subject sample||% of days with normal stool consistency||Standard Deviation|Mean
21304|NCT01747330|Primary|Stool Frequency|Average daily stool frequency during treatment period: Number of bowel movements per day|3 months|Full Analysis subject sample||Bowel movements per day||Standard Deviation|Mean
21305|NCT01747330|Primary|Height|change from baseline at day 84|3 months|Full Analysis subject sample||m||Standard Deviation|Mean
21306|NCT01747330|Primary|Body Weight|change from baseline at day 84|3 months|Full Analysis subject sample||kg||Standard Deviation|Mean
21307|NCT01746940|Primary|Immediate and Sustained Analgesic Success|The primary endpoint for this trial is analgesic success immediately after application of study drug and sustained throughout the diagnostic procedure or surgery for each nostril that received the study drug application. A subject will be considered a treatment success if they meet the following: Prior to the procedure or surgery, a 0 pain score on the 10 point pain scale (0=no pain, 10=unbearable pain) based on the Von Frey filament challenge after application of the assigned treatment solution (placebo, 4% or 10% Cocaine HCl). During the procedure or surgery, no further analgesic treatment is required (only 4% and 10% Cocaine HCl subjects who receive a procedure or surgery). Otherwise, the subject will be considered a treatment failure. Subjects with missing primary outcome data are marked as treatment failures in all treatment groups.|Prior to and During a one-day Surgery or Diagnostic Procedure|The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug and who are enrolled in the safety and efficacy phase of the study.||proportion of particpants analyzed||95% Confidence Interval|Number
21321|NCT01746511|Secondary|Peak Total Serum Bilirubin Level|Bilirubin levels were checked every 12 hours while the infant was under phototherapy. A bilirubin level was then to be checked at least twice, 8-12 hours or longer apart, following discontinuation of phototherapy.|from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks|||mg/dL||Standard Deviation|Mean
21322|NCT01746511|Secondary|Number of Episodes of Repeat Phototherapy|"Bilirubin levels are checked at regular intervals after phototherapy is discontinued to make sure levels are safe. Depending on rate of rise and predetermined unsafe bilirubin level, phototherapy may be restarted."|from time of enrollment to time of discharge, for a maximum of 10 weeks|||episodes of repeat phototherapy||Full Range|Median
21308|NCT01746862|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. For the Saizen Test Group, TEAEs were defined as events that occurred or worsened at or after the first administration of treatment and for the Saizen Control Group, TEAEs were defined as events that occurred or worsened at or after the randomization.|Baseline up to Month 13|Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.||subjects|||Number
21309|NCT01746862|Secondary|Percentage of Adherence to Study Treatment|Percentage of adherence to study treatment (adherence rate) was defined as the actual number of received treatments divided by the scheduled number of treatments multiplied by 100. The adherence rate for 6 months was calculated from Baseline to 6 months for the Saizen Test Group and from Month 6 to Month 12 for the Saizen Control Group.|6 months post-dose (Saizen Test Group and Saizen Control Group); 12 months post-dose (Saizen Test Group)|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||percentage of adherance||Standard Deviation|Mean
21310|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||mcg/L||Standard Deviation|Mean
21311|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||microgram/liter (mcg/L)||Standard Deviation|Mean
21312|NCT01746862|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12|Height SDS was calculated as: Height SDS = (measured height – population mean) / population standard deviation, where mean and standard deviation were based on the Korean standard growth charts. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject’s value was relative to the mean of the reference population. The scores were centred around zero. Negative score indicated a subject was smaller for their age/gender.|Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||standard deviation score||Standard Deviation|Mean
21313|NCT01746862|Secondary|Change From Baseline in Height at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||centimeter (cm)||Standard Deviation|Mean
21314|NCT01746862|Secondary|Change From Baseline in Height Velocity at Month 12|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 12 months prior] / 12) * 12. Height velocity at Month 12 = ([Month 12 height minus height measurement obtained at least 12 months prior] / 12) * 12.|Baseline, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.||cm/year||Standard Deviation|Mean
21315|NCT01746862|Primary|Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 6 months prior] / 6) * 12. Height velocity at Month 6 = ([Month 6 height minus height measurement obtained at least 6 months prior] / 6) * 12.|Baseline, Month 6|Intent-to-treat (ITT) analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.||centimeter/year (cm/yr)||Standard Deviation|Mean
21316|NCT01746784|Secondary|Change in Biomarkers of CFTR Function|Sweat chloride millequivalents/Liter (mEq/L)|Change from baseline at Day 7|Change from baseline sweat chloride (mEq/L) to Study Day 14||mEq/L||Standard Deviation|Mean
21317|NCT01746784|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson standards were used to calculate percent predicted FEV1 (for age, sex, and height).|Change from baseline at Day 7|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Study Day 7||percentage||Standard Deviation|Mean
21318|NCT01746784|Primary|Safety and Tolerability|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|Over 7 treatment days and 7 days of follow-up|Treatment emergent adverse events by Grade 1 (mild) to 5 (fatal)||participants|||Number
21319|NCT01746511|Secondary|Length of Initial Round of Phototherapy|time start to time finally off phototherapy, including any breaks during which they were off|from time of enrollment to time of discharge, for a maximum of 10 weeks|||hours||Standard Deviation|Mean
21324|NCT01746368|Secondary|Satisfaction|"Score on the Client Satisfaction Questionnaire-8 (CSQ-8). The overall score is produced by summing all item responses. For the CSQ-8, scores range from 8 to 32, with higher values indicating higher satisfaction.~Response options differ from item to item, but all are based on a four-point scale.~All items are positively worded; however, the directionality of response options span the spectrum from very negative to very positive; and, the numerical anchors for items are reversed randomly (from high to low or low to high) from item to item to minimize stereotypic response sets. The CSQ-8 has no subscales and reports a single score measuring a single dimension of overall satisfaction."|For participants who received the allocated intervention, up to one month after intervention; for all others, up to 90 days after consenting to the study.|||Scores on a scale||Standard Deviation|Mean
21325|NCT01746368|Primary|Number of Participants Who Completed an Advance Directive|An advance directive was considered completed upon confirmation of the scanned document in the medical record.|Up to 1 month after intervention|intention to treat (ITT)||participants|||Number
21326|NCT01746264|Secondary|Reactive Hyperemia Index (RHI)|The cuff of a sphygmomanometer was placed on the forearm and inflated to 50 mm Hg above the participant’s systolic blood pressure for a period of 5 min. The increase in resting brachial blood flow was calculated as the maximum flow recorded in the first 15 seconds after cuff deflation and expressed as a percentage increase from baseline reactive. Higher values are considered normal or improved endothelial function.|baseline, 3 months|Data for one subject could not be included as the data on RHI was lost in the system and could not be retrieved.||percentage increase in blood flow||Standard Deviation|Mean
21327|NCT01746264|Secondary|Urine Calcium to Creatinine Ratio|Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.|baseline, 3 months|||mg/g||Standard Deviation|Mean
21328|NCT01746264|Secondary|High Density Lipoprotein (HDL) Cholesterol Levels|Total HDL cholesterol levels were measured by an enzymatic colorimetric assay. The test for high-density lipoprotein cholesterol (HDL-C) is used along with other lipid tests to screen for unhealthy levels of lipids and to determine the risk of developing heart disease. If a subject has a negative risk factor, a desirable HDL level would be >/= 1.55 mmol/L.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
21329|NCT01746264|Secondary|Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels|The test for low-density lipoprotein cholesterol is used as part of a lipid profile to predict an individual's risk of developing heart disease. A desirable level is <3.36 mmol/L; borderline high is 3.36 - 4.11 mmol/L; high is >/= 4.14 mmol/L. LDL cholesterol was calculated as: LDL = Total cholesterol - HDL cholesterol - Triglycerides/5.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
21330|NCT01746264|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|A high-sensitivity C-reactive protein (hs-CRP) test may be used to help evaluate an individual for risk of cardiovascular disease (CVD). C-reactive protein (CRP) is a protein that increases in the blood with inflammation. Studies have suggested that a persistent low level of inflammation plays a major role in atherosclerosis, the narrowing of blood vessels due to build-up of cholesterol and other lipids, which is often associated with CVD. The hs-CRP test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation and thus helps predict a person's risk of developing CVD. hs-CRP was measured using particle-enhanced immunonephelometry.|baseline, 3 months|||nmol/L||Standard Deviation|Mean
21331|NCT01746264|Secondary|Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)|This calculation measures insulin resistance, and requires U.S. standard units. The healthy range is 0.5 to 1.4. Less than 1.0 means the subject is insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. The HOMA-IR was calculated as: HOMA-IR = fasting serum glucose (mmol/L) x fasting insulin (mU/mL)/22.5.|baseline, 3 months|||index of beta cell function||Standard Deviation|Mean
21332|NCT01746264|Secondary|Fasting Insulin|Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.|baseline, 3 months|||pmol/L||Standard Deviation|Mean
21333|NCT01746264|Secondary|Fasting Glucose|Plasma glucose was measured by hexokinase enzymatic assay.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
21334|NCT01746264|Secondary|Serum Parathyroid Hormone (PTH)|A parathyroid hormone (PTH) blood test measures the level of parathyroid hormone in the blood. This test is used to help identify hyperparathyroidism, to find the cause of abnormal calcium levels, or to check the status of chronic kidney disease. PTH controls calcium and phosphorus levels in the blood. PTH was measured by a two-site chemiluminescent immunometric assay.|baseline, 3 months|||pmol/L||Standard Deviation|Mean
21335|NCT01746264|Secondary|Calcium Intake Per Day|Calcium intake was measured using the validated Short Calcium Questionnaire (SCQ). This questionnaire is in the form of an spreadsheet, and asks the participant to enter the number of servings per week of various food items and vitamin or mineral supplements. The spreadsheet calculates the daily calcium intake (mg/day) from the data entered.|baseline, 3 months|||mg/day||Standard Deviation|Mean
21336|NCT01746264|Secondary|International Physical Activity Questionnaire (IPAQ) Short Form Score|The IPAQ short form used asked 7 questions about activities in the last 7 days, covering vigorous physical activities, moderate activities, walking, and sitting, asking for days per week, hours per day or minutes per day. The score is reported in metabolic equivalent (MET)-minutes per week. Possible scores could range from 0 (inactive) to greater than 3000 MET-minutes/week (highly active). The definition of high activity was vigorous intensity activity on at least 3 days achieving a minimum total activity of at least 1500 MET-minutes/week OR 7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 MET-minutes/week. Therefore a score of > 3000 MET-minutes/week was possible.|baseline, 3 months|||MET-minutes per week||Standard Deviation|Mean
21337|NCT01746264|Secondary|Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.|baseline, 3 months|||kg/m^2||Standard Deviation|Mean
21338|NCT01746264|Secondary|Triglycerides|Total triglyceride levels were measured by an enzymatic colorimetric assay.|baseline, 3 months|||mmol/L||Standard Deviation|Mean
21340|NCT01746264|Secondary|25-hydroxy Vitamin D (25[OH]D) Levels|25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Total 25(OH)D concentrations of each sample was calculated using internal standard, 25(OH)D_2 and 25(OH)D_3.|baseline, 3 months|||nmol/L||Standard Deviation|Mean
21341|NCT01746264|Primary|Flow Mediated Dilatation (FMD)|Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.|baseline, 3 months|Data for one subject could not be included as the data on FMD was lost in the system and could not be retrieved.||percentage increase in BAD||Standard Deviation|Mean
21342|NCT01746173|Secondary|Induction Response|Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy based on revised Cheson criteria (2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.|Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).|||proportion of patients||90% Confidence Interval|Number
21343|NCT01746173|Primary|24-month Progression-Free Survival Rate|24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed per revised Cheson criteria (2007).|Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.|The analysis dataset is comprised all enrolled patients.||proportion of patients||90% Confidence Interval|Number
21344|NCT01746108|Secondary|Concentrations of Antibodies Against Protein D (PD) in the Healthy Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
21345|NCT01746108|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. When number of subjects analysed = 1, Lower limit and Upper Limit values were entered as equal to the Geometric mean value. “999999.9” was used as placeholder when Upper Limit value was greater than “1.0E8”.|One month after Dose 1 (At Month 1) and/or one month after Dose 2 (At Month 3)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||Titers||95% Confidence Interval|Geometric Mean
21346|NCT01746108|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
21347|NCT01746108|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of study subjects|From Dose 1 at Month 0 up to study end at Month 1 for primed subjects and at Month 3 for unprimed subjects.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21348|NCT01746108|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post- vaccination period|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21349|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21392|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for Methotrexate (MTX)|Plasma decay half-life is the time measured for the plasma concentration of MTX to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Standard Deviation|Mean
21350|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21351|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21352|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21353|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21354|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain =Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21355|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21356|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
21357|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
21358|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
21368|NCT01745952|Secondary|Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment|Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.|week 12 after each treatment|baseline weekly seizure frequency over all participants was 24.8 (95% confidence interval 8.2-76.1)||seizures/week||95% Confidence Interval|Mean
21359|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was~≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||Titers||95% Confidence Interval|Geometric Mean
21360|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was~≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||Titers||95% Confidence Interval|Geometric Mean
21361|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A,~-19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
21362|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This cohort included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.||μg/mL||95% Confidence Interval|Geometric Mean
21363|NCT01745952|Other Pre-specified|Adverse Event Rate||during the 9 months of the study|||participants|||Number
21364|NCT01745952|Other Pre-specified|Drop Out-rate|exclusion by investigator was due to necessity to change drug regimen due to toxicity|during the 9 months of the study|for this analysis, all patients randomised were included; this includes one patient in the second arm that was not included in any of the other outcome measures, due to lack of reliable outcome parameters||participants|||Number
21365|NCT01745952|Other Pre-specified|Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale|"Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life.~Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment~Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk~change in QOLIE scores considered better/worse are based on cut-off reported in DOI 10.1016/j.yebeh.2011.12.023 For global impression of change, the scoring was <4, 4 or >4."|before the first treatment of each session and at the last evaluation visit|* Self-reporting questionnaires could only be filled in by 7 participants For global impression of change scales, the score reached by consensus between the patient and caregiver(s) was used if patient was unable to fill in questionaires: for the three arms, we thus have 7/8/6 scores for each arm respectively||participants|||Number
21366|NCT01745952|Other Pre-specified|Difference in Seizure Reduction Using Different Coil Types|any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data|9 months|averaged weekly seizure count per condition is given for all patients combined||number of seizures per week||95% Confidence Interval|Mean
21367|NCT01745952|Other Pre-specified|Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level|Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.|within one week after the last treatment day of each session|"patients of whom seizure journals were incomplete also included (one participant who went through all 3 trials and one patient of whom journals were not available from the sham session, that was reported by the patient as ineffective)"||participants|||Number
21369|NCT01745952|Primary|50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment|Number of participants achieving a 50% or greater reduction in seizure frequency from baseline|week 12 after each intervention|||participants|Participants||Number
21370|NCT01745380|Other Pre-specified|Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia.|at 25 minutes, +3 minute window|This analysis is only of the participants who received 3 sprays. It does not include participants who only received 2 sprays.||participants|||Number
21371|NCT01745380|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
21372|NCT01745380|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
21373|NCT01745380|Secondary|Alcohol Sniff Test|The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on a cotton ball.|administered at approximately 24 hours after drug administration|||cm||Standard Deviation|Mean
21374|NCT01745380|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration|||beats per minute||Standard Deviation|Mean
21375|NCT01745380|Secondary|Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
21376|NCT01745380|Secondary|Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 120 minutes following drug administration|||mmHg||Standard Deviation|Mean
21377|NCT01745380|Secondary|Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration|||bpm||Standard Deviation|Mean
21378|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg||at any time within 120 minutes following study drug administration|||participants|||Number
21379|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg||at any time within 120 minutes following study drug administration|||participants|||Number
21380|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg||at any time within 120 minutes following study drug administration|||participants|||Number
21381|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration|||participants|||Number
21382|NCT01745380|Secondary|Number of Participants With a Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration|||participants|||Number
21383|NCT01745380|Secondary|Number of Participants With a Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration|||participants|||Number
21384|NCT01745380|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older.|at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used|Participants were only analyzed in their corresponding age group.||percentage of participants|||Number
21385|NCT01745380|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 15 minutes, +3 minute window|||participants|||Number
21386|NCT01745133|Primary|Physician Global Assessement|"Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear~= almost clear~= mild~= moderate~= severe"|10 weeks|||percentage of patients|||Number
21387|NCT01745055|Secondary|Renal Clearance (CL R) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||L/hr||Standard Deviation|Mean
21388|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||milligram||Standard Deviation|Mean
21389|NCT01745055|Secondary|Renal Clearance (CL R) for CP-690,550||0 (pre-dose) through 24 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||litre/hour (L/hr)||Standard Deviation|Mean
21390|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550||0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||milligram||Standard Deviation|Mean
21391|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for Methotrexate (MTX)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||mL/hr||Standard Deviation|Mean
21393|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 ,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Full Range|Median
21394|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for CP-690,550|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||mL/hr||Standard Deviation|Mean
21395|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for CP-690,550|Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Standard Deviation|Mean
21396|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||hour||Full Range|Median
21397|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||ng/mL||Standard Deviation|Mean
21398|NCT01745055|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||ng*hr/mL||Standard Deviation|Mean
21399|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||ng/mL||Standard Deviation|Mean
21400|NCT01745055|Primary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550|AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The pharmacokinetic (PK) analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
21401|NCT01744977|Secondary|Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months|obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months)|Baseline, 6months, 12months|Cholesterol values could not be obtained for all patients at all time points.||mg/dL||Standard Deviation|Mean
21402|NCT01744977|Primary|Cholesterol Medication Adherence|Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups|12 months|Data on pill refill could not be obtained for 2 of the education only participants.||adherence proportion||Inter-Quartile Range|Median
21403|NCT01744860|Secondary|Management of Discordance-Final Result for BRAF V600 Mutation Detection|The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."||number of samples|Participants||Number
21404|NCT01744860|Secondary|Management of Discordance- Method Used to Manage Discordance|"Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor [prm. tmr]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between in-house method and Cobas 4800 mutation test."|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."||number of samples|Participants||Number
21405|NCT01744860|Secondary|Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method|This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||hours|Participants|Full Range|Median
21406|NCT01744860|Secondary|Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method|This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||days|Participants|Full Range|Median
21407|NCT01744860|Secondary|Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was No=375, was used for analysis.||number of samples|Participants|Standard Deviation|Mean
21408|NCT01744860|Secondary|Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21466|NCT01744197|Primary|Percentage of Patients With No Pain (VAS=0)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients||percentage of participants|||Number
21409|NCT01744860|Secondary|Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method|The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||ng/mcl|Participants|Standard Deviation|Mean
21410|NCT01744860|Secondary|Technician Work Time Between DNA Extraction and Result by “In-house” Analytical Method|The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||hours|Participants|Full Range|Median
21411|NCT01744860|Secondary|Median Time Between Receipt of Samples and Determination of Result by “In-house” Analytical Method|This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||days|Participants|Full Range|Median
21412|NCT01744860|Secondary|Mean Number of Slices Per Sample Used for “In-house”- Analytical Method|The mean of number of slices per sample when no punch was used are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was not used were considered for analysis.||number of samples|Participants|Standard Deviation|Mean
21413|NCT01744860|Secondary|Number of Samples Punched in In-house Analytical Method|Total number of samples for whom punch was used in 'in-house analytical' method are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21414|NCT01744860|Secondary|Method of Mutation Detection by “In-house” Analytical Method|Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21415|NCT01744860|Secondary|Size of Amplicons Used by “In-house” Analytical Method|The method described the size of amplicon used. It was measured in base pairs (bp).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||bp|Participants|Full Range|Median
21416|NCT01744860|Secondary|Amount of DNA by Pre-analytical Method|The total DNA concentration extracted from the tissue was measured in nanogram (ng).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||ng|Participants|Standard Deviation|Mean
21417|NCT01744860|Secondary|Mean DNA Concentration by Pre-analytical Method|The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||ng/mcl|Participants|Standard Deviation|Mean
21418|NCT01744860|Secondary|Median DNA Elution Volume by Pre-analytical Method|Median DNA elution volume microliters [mcl] was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||mcl|Participants|Full Range|Median
21419|NCT01744860|Secondary|DNA Extraction – Extraction Method by Pre-analytical Method|This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21420|NCT01744860|Secondary|Tumor Samples With Presence of Melanin by Pre-analytical Method|The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only available samples were included for analysis.||number of samples|Participants||Number
21421|NCT01744860|Secondary|Percentage of Tumor Cells by Pre-analytical Method|The percentage of tumor cells in the given tumor sample were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||percentage|Participants|Standard Deviation|Mean
21422|NCT01744860|Secondary|Necrosis Percentage Determination by Pre-analytical Method|The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only 341 samples out of 420 were analysed as the information on presence of necrosis was missing for 79 samples in the assessed zones.||percentage|Participants|Standard Deviation|Mean
21423|NCT01744860|Secondary|Dewaxing by Pre-analytical Method|Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as “Yes, No or Missing”|Up to 6 Months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21424|NCT01744860|Secondary|Slice Thickness by Pre-analytical Method|Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||micrometer (µm)|Participants|Standard Deviation|Mean
21425|NCT01744860|Secondary|Fixation Duration by Pre-analytical Method|Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as <6 hours, 6-24 hours and >24 hours and unknown. Number of samples falling in each category were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21426|NCT01744860|Secondary|Type of Fixative Used- Pre-analytical Method|The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21427|NCT01744860|Secondary|Time From Sampling to Fixation- Pre-analytical Method|Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, >6 hours and unknown. Number of samples falling in each of the class were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21428|NCT01744860|Secondary|Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method|The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21429|NCT01744860|Secondary|Tumor Sample Characteristics - Source of Tumor Sample|The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.||number of samples|Participants||Number
21430|NCT01744860|Secondary|Tumor Sample Characteristics-Type of Tumor Sample|The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis||number of samples|Participants||Number
21431|NCT01744860|Primary|BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories|"BRAF V600 mutation status was determined by INCa molecular laboratories “in-house” methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory in-house method."|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. n = number of samples with BRAF V600 mutation by “in-house method”.||number of samples|Participants||Number
21432|NCT01744821|Secondary|Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.|Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D|Up to 24 months|||participants|||Number
21433|NCT01744821|Secondary|Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers|"The outcomes that will be measured for the secondary objectives of this study will include the following:~Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24"|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.|||||
21434|NCT01744821|Primary|Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Decrease in cellular proliferation measured by immunohistochemistry staining with KI67|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.|||||
21435|NCT01744821|Primary|The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical.|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.|||||
21436|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese & non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below.~Sampling schedule details for PTN_POPS & Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/kg||Full Range|Median
21437|NCT01744730|Post-Hoc|Half-life|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for half-life by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After participant transitioned from IV Clindamycin to oral Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||hours||Full Range|Median
21467|NCT01744197|Primary|Percentage of Patients With No or Minor Pain (VAS<3)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients.||percentage of participants|||Number
21438|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L||Full Range|Median
21439|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/h/70 kg||Full Range|Median
21440|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/h/kg||Full Range|Median
21441|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.||L/h||Full Range|Median
21442|NCT01744691|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population.||participants|||Number
21443|NCT01744691|Primary|Overall Response Rate|The primary objective of this study is to evaluate the efficacy of PCI-32765 in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.|The median time on study for all treated participants is 11.5 (range 0.5 - 16.6) months|||% of participants with response by IRC||95% Confidence Interval|Number
21468|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months||||||
24077|NCT01700387|Secondary|Pharmacoeconomic Estimates on Number of Patients Needed to Treat (Randomize) to Have One Successful Patient at 3, 6, 9, and 12 Months.||12 Months||||||
21444|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease|"The classification of pain in Parkinson’s disease scale classifies pain in the following domains: musculoskeletal pain (item 1), chronic pain (items 2 and 3), fluctuation related pain (items 4, 5 and 6), nocturnal pain (items 7 and 8), oro-facial pain (items 9, 10 and 11), discoloration; edema/swelling (items 12 and 13), and radicular pain (item 14). Severity of the pain is measured on a scale from none (0) to severe (3) and frequency is measured on a scale from never (0) to very frequent (4).~A score of a single item was calculated by multiplying severity with frequency. A domain score was calculated as the sum of every individual score related to the respective domain. A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
21445|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject’s activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
21446|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
21447|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
21448|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
21449|NCT01744496|Secondary|Percentage of Responders at the End of the Maintenance Period|Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||percentage of responders|||Number
21450|NCT01744496|Primary|Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale|"An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).~The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit – 7 days). A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.||scores on a scale||Standard Deviation|Mean
21451|NCT01744392|Secondary|Pulse at 6 Months|Clinical Characteristics at 6 month for Pulse|6 months|||beats per minute||Standard Deviation|Mean
21452|NCT01744392|Secondary|Pulse at Baseline|Clinical Characteristics at Baseline for Pulse|baseline|||beats per minute||Standard Deviation|Mean
21453|NCT01744392|Secondary|Weight at 6 Months|Clinical Characteristics at 6 months for Weight|6 months|||pounds||Standard Deviation|Mean
21454|NCT01744392|Secondary|Weight at Baseline|Clinical Characteristics at Baseline for Weight|baseline|||pounds||Standard Deviation|Mean
21455|NCT01744392|Secondary|Cholesterol & Creatinine Levels at 6 Months|Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine|6 months|||mg/dL||Standard Deviation|Mean
21456|NCT01744392|Secondary|Cholesterol & Creatinine Levels at Baseline|Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine|baseline|||mg/dL||Standard Deviation|Mean
21457|NCT01744392|Secondary|Blood Pressure at 6 Months|Clinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,|6 months|||mmHg||Standard Deviation|Mean
21458|NCT01744392|Secondary|Blood Pressure at Baseline|Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,|baseline|||mmHg||Standard Deviation|Mean
21459|NCT01744392|Primary|Medication Possession Ratio at 6 Months|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for 6 months MPR 6 months after enrollment."|6 months|||percentage of medication possession||Standard Deviation|Mean
21460|NCT01744392|Primary|Medication Possession Ratio at Baseline|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for baseline MPR 12 months prior to enrollment."|baseline|||percentage of medication possession||Standard Deviation|Mean
21461|NCT01744353|Secondary|Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.|Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters|pre-drug until disease progression, whichever comes first, for an expected average of 6 months|||participants|||Number
21462|NCT01744353|Primary|Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.|MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.|For up to 30 days post completing drug, an expected average of 6 months|||participants|||Number
21463|NCT01744340|Secondary|Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.|"This shows patients able to achieve Stable disease or better as their best response during course of study participation. Response will be evaluated by Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1 RECIST Guideline version 1.1 Response Criteria Complete Response:Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|From beginning of treatment to progression of disease, for an expected average of 1 year|||participants|||Number
21464|NCT01744340|Primary|If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer.|"A DLT was defined as:~Grade 4 neutropenia (ANC < 500/mm3) for > 7 days~ANC <1000/mm3 with fever or infection~Platelets <25,000/mm3~Platelets <50,000/mm3 requiring transfusion~Grade 3 or grade 4 treatment related non-hematologic toxicities excluding alopecia. Grade 3 nausea, vomiting or diarrhea will only be considered a dose limiting toxicity if it occurs despite maximal medical support. Grade 3 or grade 4 hypomagnesemia will not be considered a dose limiting toxicity since it is an expected side effect of cetuximab and can be corrected. Other grade 3 or grade 4 electrolyte abnormalities will not be considered dose limiting toxicities if the electrolyte disorder can be corrected to grade 2 or less within 72 hours.~EGFR dermatologic toxicity should be graded according to the toxicity scale for EGFR associated reactions. The first episode of grade 3 or grade 4 rash will not be considered a DLT.~If any patient receives < 70% of the planned dose of eribulin mesylat"|From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days|Outcome measure that address the dose of 1.4 mg/m2,6 patients were treated (1 head and neck 5 colon). 12 patients were enrolled in the course of the MTD dose finding,10 colon and 2 head and neck. All other results sections are inclusive of all patients(dose finding +expansion cohort).||participants|||Number
21465|NCT01744197|Secondary|Global Assessment of Satisfaction With Venipuncture|Rates of Satisfied and very satisfied are used to be compared between two groups.|30 minutes after the venipuncture.|Normal completion patients||percentage of participants|||Number
21469|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months||||||
21470|NCT01743963|Secondary|Feasibility/Reach/Adoption|"Measurements of intervention delivery include the representativeness of providers (differences between participants/non-participants). Results reported using descriptive statistics (proportions, means, standard deviations, and ranges)."|12 months||||||
21471|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include recruitment numbers and provider Participation Rates for enrollment and retention. The definition of study feasibility consists of provider enrollment rates >= 50%. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months||||||
21472|NCT01743963|Primary|Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).|For follow-up laboratory data within the VA system, adherence will be monitored through prospective accrual of administrative data and review of the medical record. Results will be reported as the proportion receiving the preventive measure versus time, i.e. with Kaplan-Meier plots. We will then determine the variance of Delay Interval. For the preliminary measure of efficacy, the Delay Interval will be compared between patients whose providers were assigned to the intervention and patients whose providers did not receive the intervention.|6 MONTHS|21 patients cared for by 6 providers in intervention arm; 17 patients cared for by 6 providers in usual care arm.||Days||95% Confidence Interval|Mean
21473|NCT01743521|Secondary|Gene IL28B Polymorphism|To examine treatment outcome by IL28B polymorphism|Baseline||||||
21474|NCT01743521|Secondary|CD4 and HIV RNA|In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||||
21475|NCT01743521|Secondary|Plasma Ribavirin Levels and Haemoglobin|To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||||
21476|NCT01743521|Secondary|Baseline Resistance-associated Variants|To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||||
21477|NCT01743521|Secondary|Resistance-associated Variants|To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||||
21478|NCT01743521|Secondary|Fall in Hemoglobin at End of Treatment|To evaluate indicators of toxicity during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||g/L||Inter-Quartile Range|Median
21479|NCT01743521|Secondary|Decrease in Platelets <50||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||participants|||Number
21480|NCT01743521|Secondary|Decrease in Absolute Neutrophil Count (ANC) ≤0.75||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||participants|||Number
21481|NCT01743521|Secondary|Undetectable HCV RNA (Week 4)|To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.|Week 4 of therapy|Missing data carried forward if previously <LLoQ||percentage of participants|||Number
21482|NCT01743521|Secondary|Undetectable HCV RNA (Week 3)|To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.|Week 3 of therapy|Missing data carried forward if previously <LLoQ (lower limit of quantification)||percentage of participants|||Number
21483|NCT01743521|Secondary|Undectectable HCV RNA (Week 2)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 2 of therapy|||percentage of participants|||Number
21484|NCT01743521|Secondary|Undetectable HCV RNA (Week 1)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 1 of therapy|||percentage of participants|||Number
21485|NCT01743521|Secondary|Undetectable HCV RNA (ETR)|To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)|Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|||percentage of participants|||Number
21486|NCT01743521|Secondary|SVR24|To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)|24 weeks post-treatment|||percentage of participants|||Number
21487|NCT01743521|Primary|SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)|Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)|12 weeks post-treatment|||percentage of participants|||Number
21488|NCT01743092|Secondary|DASS Depression|"The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. & Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation).~The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+"|12 weeks|The number of data points in this analysis equals the number who completed the study.||units on a scale||Standard Deviation|Mean
21489|NCT01743092|Primary|Perceived Stress Scale|"The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one’s life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress.~The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels."|12 weeks|The number of data points in this analysis equals the number who completed the study, minus 2. There were 2 missing data points in this analysis because two people did not complete the questionnaire.||units on a scale||Standard Deviation|Mean
21557|NCT01741688|Secondary|Number of Participants Discontinued From Tocilizumab for Other Reasons|This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.|Approximately 16 months|||participants|||Number
21490|NCT01743027|Secondary|Proportion of Itch Responders at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 1|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis.||percentage of participants|||Number
21491|NCT01743027|Secondary|Proportion of Ocular Itching Responders at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 14|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis.||percentage of participants|||Number
21492|NCT01743027|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
21493|NCT01743027|Secondary|Mean Total Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
21494|NCT01743027|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
21495|NCT01743027|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
21496|NCT01743027|Primary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 1 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
21497|NCT01743027|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 14 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.||units on a scale||Standard Error|Least Squares Mean
21498|NCT01742936|Primary|International Normalized Ratio (INR) Performed by Hospital Laboratory|Measuring the bloods ability to clot by the hospital's reference laboratory.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)|Three cases of device error with CoaguChek®, 1 insufficient blood for measurement in the laboratory, and 1 communication failure during sending the blood sample to the laboratory occurred leaving 87 patients for analysis.||ratio||Standard Deviation|Mean
21499|NCT01742936|Primary|International Normalized Ratio (INR) on CoaguChek|Measuring the blood's ability to clot on a handheld monitor.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)|||ratio||Standard Deviation|Mean
21500|NCT01742897|Primary|Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30|The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst).|Baseline, Day 30|Intent-to-treat (ITT) analysis population included all participants regardless of their compliance with the protocol.||Millimeter (mm)||95% Confidence Interval|Median
21501|NCT01742364|Other Pre-specified|Fluid Leakage on Skin at Injection Site||Immediately post-vaccination|For adults, the skin fluid deposition was estimated and categorized by the vaccinator (e.g., no wetness, damp skin, flow on skin, spray in air); for infants, volume was measured objectively and categorized by the filter paper technique (units in µl).||participants|||Number
21502|NCT01742364|Other Pre-specified|Diameter of Skin Bleb||Immediately post-vaccination|||participants|||Number
24078|NCT01700387|Secondary|Subject Estimation of Compliance With Daily Topiramate||12 Months||||||
21503|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.~Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|14 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.~Immunogenicity was not measured for adults in the study."||percentage responding to cytokines||Inter-Quartile Range|Median
21504|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 (Cluster of Differentiation 4) T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.~Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|10 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.~Immunogenicity was not measured for adults in the study."||percentage responding to cytokines||Inter-Quartile Range|Median
21505|NCT01742364|Primary|Systemic Adverse Events|Systemic adverse events, solicited and unsolicited, including symptoms of lethargy, disrupted feeding patterns, fever, lymphadenopathy, rash, or any other physical abnormalities will be monitored for up to fourteen weeks following vaccination.|14 weeks|||Adverse events|||Number
21506|NCT01742364|Primary|Injection Site Adverse Events (Following Injection)|Injection site adverse events including redness, swelling, induration, tenderness, ulceration, fluctuation , drainage, laceration, bruising, and scarring will be monitored for up to fourteen weeks following vaccination.|14 weeks|||Adverse events|||Number
21507|NCT01741792|Secondary|CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
21508|NCT01741792|Secondary|CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21509|NCT01741792|Secondary|CD8+ TEM Cells as a Percentage of All CD8+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
21510|NCT01741792|Secondary|CD8+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21511|NCT01741792|Secondary|CD8+ TCM Cells as a Percentage of All CD8+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
21558|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy|Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.|Approximately 16 months|||percentage of participants|||Number
24079|NCT01700387|Secondary|MEWT Scores for Mathematical Processing Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months||||||
21512|NCT01741792|Secondary|CD8+ TCM Cell Counts|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||100 cells/µL||Standard Deviation|Mean
21513|NCT01741792|Secondary|CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD8+ T-cells||Standard Deviation|Mean
21514|NCT01741792|Secondary|CD8+ Naive T-Cell Count|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21515|NCT01741792|Secondary|CD4+ TEM Cells as a Percentage of All CD4+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD4+ T-cells||Standard Deviation|Mean
21516|NCT01741792|Secondary|CD4+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21517|NCT01741792|Secondary|CD4+ TCM Cells as a Percentage of All CD4+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD4+ T-cells||Standard Deviation|Mean
21518|NCT01741792|Secondary|CD4+ Central Memory T-Cell (TCM) Count|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21519|NCT01741792|Secondary|CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of CD4+ T-cells||Standard Deviation|Mean
21520|NCT01741792|Secondary|CD4+ Naive T Cell Count|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21532|NCT01741792|Secondary|Monocyte Counts||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21521|NCT01741792|Secondary|CD4+ T-Cell to CD8+ T-Cell Ratio|CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||ratio||Standard Deviation|Mean
21522|NCT01741792|Secondary|CD19+ B-Cell to CD3+ T-Cell Ratio|CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||ratio||Standard Deviation|Mean
21523|NCT01741792|Secondary|CD8+ T-Cells as a Percentage of All Lymphocytes|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
21524|NCT01741792|Secondary|CD8+ T-Cell Count|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21525|NCT01741792|Secondary|CD4+ T-Cells as a Percentage of All Lymphocytes|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
21526|NCT01741792|Secondary|CD4+ T-Cell Count|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21527|NCT01741792|Secondary|CD3+ T-Cells as a Percentage of All Lymphocytes|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
21528|NCT01741792|Secondary|CD3+ T-Cell Count|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21529|NCT01741792|Secondary|CD19+ B-Cells as a Percentage of All Lymphocytes|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||percentage of lymphocytes||Standard Deviation|Mean
21530|NCT01741792|Secondary|CD19+ B-Cell Count|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21531|NCT01741792|Secondary|Granulocyte Count||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
24080|NCT01700387|Secondary|MEWT Scores for Matching to Sample Sub-test at Visit 2-6 to Measure Mental Efficiency||12 Months||||||
21533|NCT01741792|Secondary|Lymphocyte Counts|Lymphocyte counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21534|NCT01741792|Secondary|Leukocyte Counts|Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).||1000 cells/µL||Standard Deviation|Mean
21535|NCT01741792|Secondary|Blinatumomab Steady State Serum Concentration|Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.|Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)|Pharmacokinetic (PK) data set (all participants who received any infusion of blinatumomab and had at least one PK sample collected).||pg/mL||Standard Deviation|Mean
21536|NCT01741792|Secondary|Number of Participants With Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.~An adverse event or suspected adverse drug reaction was considered serious if it resulted in one of the following outcomes:~Resulted in death;~Was life-threatening;~Required inpatient hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions;~Was a congenital anomaly or birth defect;~Was a medically important condition.~The Investigator used medical judgment to determine whether there was a causal relationship (ie, related [reasonably possible] or unrelated [not reasonably possible]) between an adverse event and blinatumomab."|From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.|Safety analysis set||participants|||Number
21537|NCT01741792|Secondary|Overall Survival (OS)|The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.|From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.|Efficacy set||months||95% Confidence Interval|Median
21538|NCT01741792|Secondary|Progression-free Survival (PFS)|The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.|From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.|Efficacy set||months||95% Confidence Interval|Median
21539|NCT01741792|Secondary|Duration of Partial Response|The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of PR during the first treatment cycle||months||95% Confidence Interval|Median
21540|NCT01741792|Secondary|Duration of Complete Response|The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of CR during the first treatment cycle||months||95% Confidence Interval|Median
21541|NCT01741792|Secondary|Duration of Objective Response|The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with an overall objective response of CR or PR during the first treatment cycle||months||95% Confidence Interval|Median
21542|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Partial Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (<50% decrease in size of masses) of measureable disease and no new sites.|During the first 8 weeks|Efficacy set||percentage of participants||95% Confidence Interval|Number
24081|NCT01700387|Secondary|MEWT Score for Running Memory Continuous Performance Task Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months||||||
21543|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Complete Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.|During the first 8 weeks|Efficacy set||percentage of participants||95% Confidence Interval|Number
21544|NCT01741792|Primary|Overall Objective Response Rate During Treatment Cycle 1|"Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR).~Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites."|During the first 8 weeks|Efficacy Set includes all participants who completed at least 7 days of infusion on the highest intended dose level.||percentage of participants||95% Confidence Interval|Number
21545|NCT01741701|Secondary|NonMotor Symptom Questionnaire (NMSQuest)|"The NMSQuest is a 30 item questionnaire with 30 yes/no questions. There is a total of 30 points with each yes score representing 1 point and therefore the higher the score the greater number of nonmotor symptoms present. The score can range from 0 to 30."|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
21546|NCT01741701|Secondary|Geriatric Depression Scale (GDS)|The GDS is a measure of depression. The scale has 30 yes/no questions. Each question has a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score the greater the depression.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
21547|NCT01741701|Secondary|Montreal Cognitive Assessment (MoCA)|The MoCA is an assessment of cognitive function. The total possible score ranges from 0 to 30 points with a lower score representing greater cognitive impairment.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
21548|NCT01741701|Secondary|Parkinson's Disease Questionnaire - 39 (PDQ-39)|The PDQ-39 is a measure of quality of life in Parkinson's disease patients. It has 39 questions each with a response from 0-4 for a total of 156 points. The total score is calculated as a percentage so the scores of the 39 items are added and divided by 156 and multiplied by 100. The higher the score the worse quality of life.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||percentage of total possible score||Standard Deviation|Mean
21549|NCT01741701|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). This measure examined the ADL + Motor subscales which have a total of 160 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
21550|NCT01741701|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). The total scores represents the sum of each of these sections for a total of 176 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
21551|NCT01741688|Secondary|Disease Activity Score Based on 28 Joints (DAS28)|"The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad.~The Score is developed under the follow formula:~DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score.~This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission."|At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks|||DAS28 score||Full Range|Median
21552|NCT01741688|Secondary|Total Swollen Joint Count (SJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks|||Number of swollen joints/participant||Full Range|Median
21553|NCT01741688|Secondary|Total Tender Joint Count (TJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks|||Number of tender joints/participant||Full Range|Median
21554|NCT01741688|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||At baseline|||percentage of participants|||Number
21555|NCT01741688|Secondary|Non-adherence Rate of Physician to the Recommended Dosing Regimen||Approximately 16 months||||||
21556|NCT01741688|Secondary|Time to Restoration of Initial Dosing Regimen||Approximately 16 months||||||
24082|NCT01700387|Secondary|MEWT Score for Simple Reaction Time Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months||||||
21559|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety|Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.|Approximately 16 months|||percentage of participants|||Number
21560|NCT01741688|Secondary|Median Duration of Treatment||Approximately 16 months|||months||Full Range|Median
21561|NCT01741688|Secondary|Number of Participants With Dose Modifications at 6 Months||At 6 months|||participants|||Number
21562|NCT01741688|Secondary|Median Dose at 6 Months||At 6 months|Number of participants remaining in the study at 6 months||mg/kg of body weight||Full Range|Median
21563|NCT01741688|Secondary|Number of Participants Starting Tocilizumab After Failing Other Biologic Agents|Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.|At baseline|||participants|||Number
21564|NCT01741688|Secondary|Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment includes participants, who were treated with DMARDs 6 months before being included in the study. DMARDs treatment at baseline includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab."|At baseline|||percentage of participants|||Number
21565|NCT01741688|Secondary|Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis|Systemic manifestation measured by C-reactive protein levels > 3|At baseline|||percentage of participants|||Number
21566|NCT01741688|Primary|Number of Participants on Tocilizumab at 6 Months After Treatment Initiation||At 6 months|||participants|||Number
21567|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
21568|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
21569|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
21570|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21571|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
21572|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
21573|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
21574|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
21575|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21576|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
21577|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
21578|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
21579|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
21580|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21581|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
21582|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|12-month follow up|||units on a scale||Standard Error|Mean
21583|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|6-month follow up|||units on a scale||Standard Error|Mean
21584|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|3-month follow up|||units on a scale||Standard Error|Mean
21585|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21586|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Baseline|||units on a scale||Standard Error|Mean
21587|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|12-month follow up|||units on a scale||Standard Error|Mean
21588|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|6-month follow up|||units on a scale||Standard Error|Mean
21589|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|3-month follow up|||units on a scale||Standard Error|Mean
21590|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21591|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Baseline|||units on a scale||Standard Error|Mean
21592|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|12-month follow up|||percentage of correct steps||Standard Error|Mean
21593|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|6-month follow up|||percentage of correct steps||Standard Error|Mean
21594|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|3-month follow up|||percentage of correct steps||Standard Error|Mean
21595|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Immediately Post-Intervention, at 4 weeks|||percentage of correct steps||Standard Error|Mean
21596|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Baseline|||percentage of correct steps||Standard Error|Mean
24083|NCT01700387|Secondary|Subject's Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life||12 Months||||||
21597|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|12-month follow up|||percentage of correct steps||Standard Error|Mean
21598|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|6-month follow up|||percentage of correct steps||Standard Error|Mean
21599|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|3-month follow up|||percentage of correct steps||Standard Error|Mean
21600|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Immediately Post-Intervention, at 4 weeks|||percentage of correct steps||Standard Error|Mean
21601|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Baseline|||percentage of correct steps||Standard Error|Mean
21602|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
21603|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
21604|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
21605|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21606|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
21607|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
21608|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
21609|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
21610|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21611|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
21612|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|12-month follow up|||units on a scale||Standard Error|Mean
21613|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|6-month follow up|||units on a scale||Standard Error|Mean
21692|NCT01738971|Secondary|Pharmacy Recruitment Rates|Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group.|8 months|||participants|||Number
21614|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|3-month follow up|||units on a scale||Standard Error|Mean
21615|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21616|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Baseline|||units on a scale||Standard Error|Mean
21617|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles)."|12-month follow up|||units on a scale||Standard Error|Mean
21618|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|6-month follow up|||units on a scale||Standard Error|Mean
21619|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|3-month follow up|||units on a scale||Standard Error|Mean
21620|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21621|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Baseline|||units on a scale||Standard Error|Mean
21622|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|12-month follow up|||units on a scale||Standard Error|Mean
21623|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|6-month follow up|||units on a scale||Standard Error|Mean
21624|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|3-month follow up|||units on a scale||Standard Error|Mean
21625|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|Immediately Post-Intervention, at 4 weeks|||units on a scale||Standard Error|Mean
21626|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|Baseline|||units on a scale||Standard Error|Mean
21627|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|12-month follow up|||Percentage of correct steps||Standard Error|Mean
21628|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|6-month follow up|||Percentage of correct steps||Standard Error|Mean
21629|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|3-month follow up|||Percentage of correct steps||Standard Error|Mean
21630|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Immediately Post-Intervention, at 4 weeks|||Percentage of correct steps||Standard Error|Mean
21631|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Baseline|||Percentage of correct steps||Standard Error|Mean
21632|NCT01741272|Secondary|Complications|Incidence of any surgical or medical complications will be prospectively documented.|2 & 6 weeks, 3, 6, 12, 24 months|37 subjects (17 Early Mobilization, 20 Standard Rehabilitation) had non-re-tear complications. 5 subjects reported more than one complication.||participants|||Number
21652|NCT01740713|Primary|Cmax|Maximum concentration reached in plasma. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||microM||Inter-Quartile Range|Median
21653|NCT01740713|Primary|Ka|Absorption rate constant. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||h^-1||Standard Error|Mean
21633|NCT01741272|Secondary|Abduction Strength Using the Power Component of the Constant Score|The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.|Baseline, 24 months|||units on a scale||Inter-Quartile Range|Mean
21634|NCT01741272|Secondary|WORC Questionnaire|Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.|Baseline, 6, 12, 24 months|||units on a scale||Inter-Quartile Range|Mean
21635|NCT01741272|Secondary|Pain Questionnaire|Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.|Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months|||centimeters||Standard Deviation|Mean
21636|NCT01741272|Primary|Change in Range of Motion (ROM)From Baseline to 24 Months|"Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level).~Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction."|Baseline, 6 weeks, 3, 6, 12, 24 months|||degrees||Standard Deviation|Mean
21637|NCT01740817|Secondary|Extracellular Signal-regulated Kinase (ERK) Phosphorylation in Muscle|Forty eight hrs after lipid or saline infusion, muscle ERK phosphorylation will be measured by western blot. The results are compared to determine whether lipid infusion increases muscle ERK phosphorylation compared to saline infusion. Saline mean was used to normalize the data for both arms.|48 hr following lipid or saline infusion, pre-clamp|||densitometry value||Standard Error|Mean
21638|NCT01740817|Secondary|TLR4 Messenger Ribonucleic Acid (mRNA) in Muscle|"Forty eight hrs after lipid or saline infusion, muscle TLR4 mRNA levels will be measured by RT-PCR. The results are compared to determine whether lipid infusion increases muscle TLR4 mRNA expression compared to saline infusion.~Saline mean was used to normalize the data for both arms."|48 hr following lipid/saline infusion, pre-clamp|||ng TLR4 mRNA/ng Actin mRNA||Standard Error|Mean
21639|NCT01740817|Primary|Muscle Insulin Sensitivity-M Value|"Forty eight hrs after lipid or saline infusion, muscle insulin sensitivity will be measured by insulin clamp. The results are compared to determine whether lipid infusion reduces muscle insulin sensitivity compared to saline infusion..~The M value is defined as the exogenous glucose infusion rate at steady state (i.e, when the exogenous glucose infusion rate is equal to the rate of whole body glucose disposal)."|48 hr after lipid/saline infusion|||mg/kg.min||Standard Error|Mean
21640|NCT01740726|Other Pre-specified|Child's Behavior Checklist - Parent Version (CBCL-P)|Completed by parents to describe the child’s behavioral and emotional difficulties. Scores reflect observed problems and level of adaptive functioning.|18 wks., 30 wks., 42 wks.||||||
21641|NCT01740726|Other Pre-specified|Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)|Semi-structured interview that assesses psychiatric symptoms, treatments, and functional outcomes in the time period that has elapsed since the previous assessment and tracks change over time.|18 wks., 30 wks, 42 wks||||||
21642|NCT01740726|Secondary|Change in Hope Based on Children's Hope Scale (CHS)|Assesses self-perception of ability to set and work toward goals.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
21643|NCT01740726|Secondary|Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)|Assesses seriousness of suicidal intent.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
21644|NCT01740726|Secondary|Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)|Measures anxiety symptom severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
21645|NCT01740726|Secondary|Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)|Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
21646|NCT01740726|Secondary|Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)|Clinician's rating of symptom severity and improvement since baseline.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
21647|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)|Interview-based measure, completed with both the parent and child, that assesses depression severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.||||||
21648|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)|Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.|Baseline, 42 weeks|||units on a scale|||Number
21649|NCT01740713|Secondary|Adverse Events|All the medical occurrences that started after the administration of the drug|from drug administration up to 8 days post treatment|||participants|||Number
21650|NCT01740713|Primary|Cmin|Minimum plasma concentration. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||microM||Inter-Quartile Range|Median
21651|NCT01740713|Primary|Css|Plasma concentration reached at steady state. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||microM||Inter-Quartile Range|Median
21654|NCT01740713|Primary|Tmax|Time at which the maximum concentration (Cmax) is reached. Secondary pharmacokinetic parameters such as Cmax, Min, Tmax, Css and AUC (0-8h) were derived based on the individual predicted concentration vs. time profiles.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||hour||Inter-Quartile Range|Median
21655|NCT01740713|Primary|V/F|volume of distribution after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||litres||Standard Error|Mean
21656|NCT01740713|Primary|AUC (0-8h)|Area under concentration versus time curve from 0 to 8 h post dosing. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||micromol*h/L||Inter-Quartile Range|Median
21657|NCT01740713|Primary|CL/F|Plasma clearance after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)|||litre/h||Standard Error|Mean
21658|NCT01740440|Secondary|To Evaluate the Subject’s Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).|The Subject Satisfaction Assessment Scale is a 5 point scale where a subject rates their satisfaction level as Very Satisfied, Satisfied, No Opinion, Unsatisfied or Very Unsatisfied.|6 weeks, 12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations||percentage of subjects|||Number
21659|NCT01740440|Secondary|To Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Including the Global Aesthetic Improvement Scale (GAIS) at 6 Weeks Compared to Baseline|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).~The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.~For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|6 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations||units on a scale||Full Range|Mean
21660|NCT01740440|Primary|Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).~The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.~For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations.||Scores on a Scale||Full Range|Mean
21661|NCT01740388|Other Pre-specified|Bulbar Conjunctival Injection|Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)|||participants|||Number
21662|NCT01740388|Other Pre-specified|Ocular Conjunctival Discharge|Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)|Analysis population is only Subjects with non-missing data, Ocular Discharge Evaluated on the Baseline-Designated Study Eye||participants|||Number
21663|NCT01740388|Secondary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)|||participants|||Number
21664|NCT01740388|Secondary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])||participants|||Number
21665|NCT01740388|Primary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF [Last Observation Carried Forward])||participants|||Number
21666|NCT01740388|Primary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])||participants|||Number
21667|NCT01740362|Primary|Renal Clearance (CL R)|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.|0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose|Analysis set included all participants who received study medication.||mL/min||Standard Deviation|Mean
21668|NCT01740362|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||hours||Standard Deviation|Mean
21669|NCT01740362|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||hours||Full Range|Median
21670|NCT01740362|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||ng/mL||Standard Deviation|Mean
21671|NCT01740362|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
21672|NCT01740089|Other Pre-specified|Immunogenicity|Number of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.|Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment|||participants|||Number
21673|NCT01740089|Secondary|Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.||After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.|||participants|||Number
21674|NCT01740089|Secondary|Number of Randomized Patients Achieving Sustained Virologic Response (SVR) – Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.||24 weeks after last dose of study treatment|||participants|||Number
21675|NCT01740089|Secondary|Number of Randomized Patients Achieving Rapid Virologic Response (RVR) – Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.||4 weeks|||participants|||Number
21676|NCT01740089|Primary|Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.||12 weeks|||participants|||Number
21677|NCT01739803|Secondary|Days in Hospital|"We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit.~Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period."|12 months|||percentage of participants|||Number
21678|NCT01739803|Secondary|Health-related Quality of Life (HQoL)|The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting “no problems,” “some problems,” and “extreme problems.” A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death.|12 months|||units on a scale||Standard Deviation|Mean
21679|NCT01739803|Primary|Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period|"Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days’ supply of IST, the participant’s adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days’ supply, the adherence rate was calculated as follows:~1 – [(Days Between Refills – Total Days Supply)/Days Between Refills] = Adherence Rate for Quarterly Time Period~At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period."|12 months|Intention to treat, as per protocol||medication possession ratio (proportion)||Standard Deviation|Mean
21680|NCT01739595|Primary|Change in Sperm Concentration|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT||percentage of subjects|||Number
21681|NCT01739595|Primary|Subjects With Testosterone in Normal Range After Treatment|"Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.||Percentage of Subjects||95% Confidence Interval|Number
21682|NCT01739361|Secondary|Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo, Adjusted for Baseline Creatinine||72 hours||||||
21683|NCT01739361|Secondary|In-hospital Mortality||Patients will be followed through the end of their hospital stay, an average of 5 weeks||||||
21684|NCT01739361|Primary|F2-isoprostanes After 72 Hours of Acetaminophen or Placebo|F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.|72 hours after randomization|||pg/mL||Inter-Quartile Range|Median
21685|NCT01738984|Other Pre-specified|Return to Drinking Between Baseline and 12 Weeks|drinking status measured via online survey taken at baseline and 12 week|12 weeks|number of participants who never/rarely drank at baseline but reported drank 1 or more drink per week at 12 weeks.||participants|||Number
21686|NCT01738984|Secondary|Number Who Returned to Smoking From Baseline and 12 Weeks|change in smoking status between baseline and 12 week assessment will be collected via survey at baseline and at the 12 week survey|12 weeks|Number of participants who were not smoking at baseline but reported returned to smoking on 12 week survey.||participants|||Number
21687|NCT01738984|Primary|Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks|physical activity will be obtained via online surveys at the 12 week assessment point|12 weeks|||MVPA minutes per week||95% Confidence Interval|Mean
21693|NCT01738971|Primary|Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)|Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.|6-8 weeks after EC|A small number of participants were identified who had been recruited to the study although were already using an effective method of contraception (i.e. using a contraceptive pill but had forgot to take), and continued to use the same method at follow-up. These participants were excluded from analysis.||participants|||Number
21694|NCT01738919|Secondary|Flexion of the Distal Interphalangeal Joint.|Flexion of the distal interphalangeal joint. Measured with goniometer.|6 months|||degrees||95% Confidence Interval|Mean
21695|NCT01738919|Secondary|DASH|Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0–100, with 0 indicating no disability.|6 month|||units on a scale||Inter-Quartile Range|Median
21696|NCT01738919|Secondary|Complications|Number of participants with nail deformities.|6 month|||participants|||Number
21697|NCT01738919|Secondary|Bump|Number of participants with the presence of a bump on the fracture-site.|6 month|||participants|||Number
21698|NCT01738919|Secondary|Pain|Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0–10, with 0 indicating no pain.|6 month|||units on a scale||Inter-Quartile Range|Median
21699|NCT01738919|Primary|Extension Deficit in the Affected Distal Interphalangeal Joint.|Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)|6 month|||degrees extension deficit||95% Confidence Interval|Mean
21700|NCT01738750|Secondary|Hospital/Operative Dollars|A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups|Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year|||Dollar||Inter-Quartile Range|Median
21701|NCT01738750|Primary|Choice Based on Cost|The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information|Outcome assessed prior to surgical procedure with data presented within 1 year|||percentage of open appendectomy|||Number
21702|NCT01738737|Secondary|Change From Baseline in Timed Get Up and Go Test|Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||seconds||Inter-Quartile Range|Median
21703|NCT01738737|Secondary|Change From Baseline in Lequesne Functional Questionnaire|The scale varies from 0 to 24. Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||units on a scale||Inter-Quartile Range|Median
21704|NCT01738737|Secondary|Change From Baseline in Range of Motion of Flexion of the Knee|Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||degress||Inter-Quartile Range|Median
21705|NCT01738737|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index|The scale varies from 0 to 96. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||units on a scale||Inter-Quartile Range|Median
21706|NCT01738737|Primary|Change From Baseline in Visual Analogue Scale for Pain|The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks|||units on a scale||Standard Deviation|Mean
21707|NCT01738698|Secondary|Ambulatory Blood Pressure Monitoring (ABPM)||Baseline and Weeks 4 and 10|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21708|NCT01738698|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21709|NCT01738698|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21710|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21711|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 12|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21712|NCT01738698|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21713|NCT01738698|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21714|NCT01738698|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21715|NCT01738698|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21716|NCT01738698|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21717|NCT01738698|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21718|NCT01738698|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
24084|NCT01700387|Secondary|Change in Number of Headache Days Reported in 30-day Baseline Period vs. Treatment Period Months 1-12||13 Months||||||
21720|NCT01738698|Secondary|Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21721|NCT01738698|Primary|Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized|||||
21722|NCT01738646|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|3 Years|Intent-to-treat||months||95% Confidence Interval|Median
21723|NCT01738646|Secondary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.|3 Years|Intent-to-treat||months||95% Confidence Interval|Median
21724|NCT01738646|Secondary|Percentage of Participants Who Experience Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|The percentage of participants who experience grade 3 or greater, treatment-related, non-hematologic toxicities will be calculated.|2.7 Years|Intent-to-treat||percentage of participants|||Number
21725|NCT01738646|Secondary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter.|3 Years|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
21726|NCT01738646|Primary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
21727|NCT01738581|Secondary|Arm Dystonia Disability Scale|The Arm Dystonia Disability Scale (ADDS) is adapted from previous work (Fahn, 1989) where participants completed as survey of task difficulty for activities such as writing, handling utensils, and buttoning on a scale of 1–4 (1 = no difficulty ,4 = not able or marked difficulty). This is a subjective assessment of impairment due to focal hand dystonia. Scores are determined using an equation: total points scored, divided by the maximum possible (23), multiplied by the quotient by 90 and subtract from 90%. Scores range from 0%-90% with higher scores indicating more function|Assessed 1 day post-treatment|||units on a scale||Standard Deviation|Mean
21728|NCT01738581|Primary|Global Rating of Change|Symptom severity was assessed using the global rating of change (GROC). For the GROC, participants were asked to identify between one to three functions most impacted by focal hand dystonia. At posttest 1 they were then asked to select a rating of perceived change that represented the level of function compared to baseline. Perceived change consisted of a ±7 point Likert scale (+7= a very great deal better, 0= no change, -7= a very great deal worse).|Assessed 1 day post-treatment|||units on a scale||Full Range|Mean
21729|NCT01738438|Post-Hoc|15-Week Clinical Benefit Rate|The 15-week clinical benefit rate (CBR) was defined as absence of disease progression (PD) per RECIST1.1 criteria at the second disease assessment (week 15). Radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Confirmatory scans for response were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and week 15 on treatment.|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
21730|NCT01738438|Secondary|Progression Free Survival|Progression-free survival (PFS) estimated using Kaplan-Meier methods was defined as the time from registration to documented disease progression (PD) or death. Based on RECIST1.1, radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients who were event-free were censored at the date of their last disease evaluation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
21731|NCT01738438|Primary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
21732|NCT01738321|Primary|Change in Intracuff Pressure||1 day|||cmH2O||Standard Deviation|Mean
24085|NCT01700387|Primary|Subject's Controlled Oral Word Association Test (COWAT) Scores at Visits 2-6 to Measure Cognitive Efficiency||12 Months||||||
21733|NCT01737996|Primary|Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)|Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21734|NCT01737996|Primary|AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)|Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21735|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21736|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21737|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21738|NCT01737996|Primary|C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)|"Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21739|NCT01737996|Primary|Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21740|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21741|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)|"Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21742|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21743|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21744|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21745|NCT01737996|Secondary|Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
24086|NCT01700387|Primary|Subject's Mental Efficiency Workload Test (MEWT) Overall Performance Index (PI) Score at Visits 2-6 to Measure Cognitive Efficiency||12 Months||||||
21746|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21747|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21748|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21749|NCT01737996|Secondary|Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21750|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21751|NCT01737996|Primary|C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)|Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21752|NCT01737996|Primary|Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
21753|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)|Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.|PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21754|NCT01737996|Primary|Number of Healthy Subjects With AEs (Multiple Rising Dose Part)|Number of healthy subjects with any adverse event (AE) during the on-treatment period.|From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)|Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication.||participants|||Number
21755|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)|Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
21756|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng/mL/mg||Standard Deviation|Mean
21757|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment|24 Hour period|Dose-normalized MTX PK parameter AUC(0-24)/Dose used for comparison||ng*hr/mL/mg||Standard Deviation|Mean
21758|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng*hr/mL/mg||Standard Deviation|Mean
21759|NCT01737931|Secondary|Itching of Application Site Evaluated by VAS After Patch Removal|"Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods).~The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|Up to 96 hours after patch removal|FAS||Scores on a scale||Standard Deviation|Mean
21760|NCT01737931|Secondary|Skin Irritation Score After Patch Removal|Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.|Up to 72 hours after patch removal|FAS subjects with a score of ≥ 0.5 (±) at Day 3||Percentage of participants|||Number
21761|NCT01737931|Primary|Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)|"Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.~The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|24 hours after 2 mg/24 hr patch removal|FAS||Scores on a scale||95% Confidence Interval|Mean
21762|NCT01737931|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.~The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles."|24 hours after 2 mg/24 hr patch removal|Full analysis set (FAS) subjects with a score of ≥ 0.5 (±) at Day 3||Scores on a scale||95% Confidence Interval|Mean
21763|NCT01737879|Secondary|Peginesatide Dose by Visit||Baseline and Weeks 5, 9, 13, and 17|Primary analysis set, with available data at each time point (indicated by n)||mg||Standard Deviation|Mean
21764|NCT01737879|Secondary|Hemoglobin Concentration by Visit||Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21|"Primary analysis set includes all enrolled participants who received at least 1 dose of investigational product. The number of participants with available data at each time point is indicated by n."||g/dL||Standard Deviation|Mean
21765|NCT01737879|Secondary|Mean Dose of Epoetin Alfa During the Evaluation Period|No participant reached the evaluation period, therefore, this endpoint could not be evaluated.|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).||||||
21766|NCT01737879|Primary|Mean Hemoglobin Concentration During the Evaluation Period|"The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.~No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated."|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).||||||
21767|NCT01737840|Secondary|Need for Additional Drug|The investigators are measuring the need for additional drug at the end of 60 minutes.|60 th minute|||participants|||Number
21768|NCT01737840|Primary|Visual Analogue Scale Score|The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain.|30th and 60th minutes|||Visual Analogue Scale||Standard Deviation|Mean
21769|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21770|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21771|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21815|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days|||percentage of mornings|Participants||Number
21772|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21773|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal – Influenza H1N1|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21774|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21775|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H3N2 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21776|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H1N1 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21783|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percent of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations||percentage of participants|||Number
21777|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza B at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21778|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H3N2 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H3N2 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H3N2 Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||HAI antibody titers||95% Confidence Interval|Geometric Mean
21779|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H1N1 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H1N1 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations||HAI antibody titers||95% Confidence Interval|Geometric Mean
21780|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza B between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than 1 indicated an increase in HAI antibody titers against influenza B as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza B. Participants who achieved seroprotection (which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B) prior to vaccination were excluded from the analysis.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||HAI antibody titers||95% Confidence Interval|Geometric Mean
21781|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The difference in the percentage of participants that achieved seroprotection against influenza H3N2 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21782|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1|The difference in the percentage of participants that achieved seroprotection against influenza H1N1 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.||percentage of participants|||Number
21784|NCT01737684|Secondary|Apparent Terminal Half-life (t½) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||hr||Geometric Coefficient of Variation|Geometric Mean
21785|NCT01737684|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||hr||Full Range|Median
21786|NCT01737684|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
21787|NCT01737684|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vd/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||L||Geometric Coefficient of Variation|Geometric Mean
21788|NCT01737684|Secondary|Apparent Clearance (CL/F), Calculated as Dose/AUC0-∞, After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||L/hr||Geometric Coefficient of Variation|Geometric Mean
21789|NCT01737684|Primary|Area Under the Concentration Time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included the subset of participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||uM•hr||95% Confidence Interval|Geometric Mean
21790|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Prior to discharge, up to 3 hours after induction.|||units on a scale||Standard Deviation|Mean
21791|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|45 minutes post-emergence|Participants not yet discharged at the 45 minute time point||units on a scale||Standard Deviation|Mean
21792|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|30 minutes post-emergence|Participants not yet discharged at the 30 minute time point||units on a scale||Standard Deviation|Mean
21793|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|15 minutes post-emergence|Participants not yet discharged at the 15 minute time point||units on a scale||Standard Deviation|Mean
21794|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|5 minutes post-emergence|||units on a scale||Standard Deviation|Mean
21795|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Emergence (spontaneous extremity movement)|||units on a scale||Standard Deviation|Mean
21796|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Induction|||units on a scale||Standard Deviation|Mean
21797|NCT01737593|Primary|Postanesthesia Emergence Agitation (EA) Score|"EA was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. This scale measures if the: 1. Child makes eye contact with the caregiver, 2. Child’s actions are purposeful, 3. Child is aware of his/her surroundings, 4. Child is restless, 5. Child is inconsolable.~Items 1, 2, and 3 are reversed scored as follows: 4 _ not at all, 3 _ just a little, 2 _ quite a bit, 1 _ very much, 0 _ extremely. Items 4 and 5 are scored as follows: 0 _ not at all, 1 _ just a little, 2 _ quite a bit, 3 _ very much, 4_extremely. Scores of each item are summed to obtain a total PAED scale score, range 0-20, with higher PAED scores indicating a greater degree of emergence delirium.~The average PAED score of all the time points is use"|Induction,Emergence(spontaneous extremity movement),and every 5 min after emergence until the patient is discharged. This is an average of 3 hours till discharge.|||units on a scale||Standard Deviation|Mean
21798|NCT01737021|Secondary|Hospital Anxiety and Depression Scale (HADS)|Validated measure of anxiety and depression in the parent.|3-6 months post discharge from PICU||||||
21799|NCT01737021|Secondary|Impact of Events Scale (IES)|Validated measure of post-traumatic stress symptoms in the parent.|3-6 months post discharge from PICU||||||
21800|NCT01737021|Primary|The Number of Feasibility Criteria Successfully Met|"Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection.~Dependent on the number of criteria successfully met, the following classification will be used:~0-2/6 criteria met - Stop; intervention and/or study design not feasible.~3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications.~5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring.~6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is."|3-6 months post discharge from PICU|||Number of criteria successfully met|||Number
21801|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days|||number of mornings|Participants||Number
21802|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days|||number of mornings|Participants||Number
21803|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days|||number of mornings|Participants||Number
21804|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days|||number of mornings|Participants||Number
21805|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days|||number of mornings|Participants||Number
21806|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days|||number of mornings|Participants||Number
21807|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days|||percentage of mornings|Participants||Number
21808|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days|||percentage of mornings|Participants||Number
21809|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
21810|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
21811|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
21812|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||mg/dl|Participants|Standard Deviation|Mean
21813|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use|||mg/dl|Participants|Standard Deviation|Mean
21816|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 3|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3."|21 study nights|||mg/dl|Participants|Standard Deviation|Mean
21817|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 2|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2."|21 study nights|||mg/dl|Participants|Standard Deviation|Mean
21818|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 1|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes."|21 study nights|||mg/dl|Participants|Standard Deviation|Mean
21819|NCT01736917|Secondary|Self-Reported Assessment of Nausea|"the patient’s self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.~The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day."|Days 1-8 of chemotherapy regimen|54 patients completed the VAS on all 8 days and were eligible for analysis.||millimeters||Full Range|Median
21820|NCT01736917|Secondary|Use of Rescue Medications.|Total number of patients who received rescue medications.|Days 1-8 of chemotherapy regimen|||participants|||Number
21821|NCT01736917|Secondary|Total Number of Emetic Episodes|total number of emetic episodes|Days 1-8 of chemotherapy regimen|||episodes|||Number
21822|NCT01736917|Primary|Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting|complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications|Days 1-8 of chemotherapy regimen|||percentage of participants|||Number
21823|NCT01736696|Secondary|Gene Expression in Peripheral Blood|Punch biopsy and serum blood were assayed for messenger Ribonucleic acid (mRNA) gene expression by quantitative PCR using standard curve(SC) method generated by linear regression using log threshold cycle versus log(cell number). granzyme B, IFN-gamma, TNF-alpha (FasL and superfamily member 5 [SF5]), BCL2, BAX, iNOS, and CD 25 presented as control gene normalized expression(relative expression) within SC. The Relative mRNA Gene Expression Level is relative to baseline and normalized to the housekeeping gene 18 Svedberg unit ribosomal RNA (18S rRNA).|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.||relative expression unit (REU)||Standard Deviation|Mean
21824|NCT01736696|Secondary|Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against ICAM-1. Number of participants with ICAM-1 expression was to be assessed qualitatively using epidermal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis of ICAM-1 in biopsy specimens was not performed as it often continues to be expressed on vessels in the skin even when psoriasis was resolved, thus would not provide a measure of response to therapy.|||||
21825|NCT01736696|Secondary|Number of Participants With Keratin 16 (K16) Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against K16. Number of participants with K16 expression were assessed qualitatively using suprabasal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
21826|NCT01736696|Secondary|Immunohistochemistry From Psoriatic Plaque Biopsies|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against cluster of differentiation 3 (CD3) and cluster of differentiation 8 (CD8) T-lymphocytes, cluster of differentiation 16/56 (CD16/56) natural killer cells, and cluster of differentiation 83 (CD83) mature dendritic cells. Baseline was defined as mean of samples obtained at the screening visit within 7 days prior to Day 1, at the baseline biopsy, and Day 0. Immunohistochemistry results were planned to be analyzed for participants who received CP-690,550 5, 20, 30 mg and matching placebo.|Baseline (within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.||cells/microliter (cells/μL)||Standard Deviation|Mean
21840|NCT01736696|Primary|Change From Baseline in Immune Cell Function at Day 14|The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, >= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.|Baseline (Within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.||ng/mL||Standard Deviation|Mean
21827|NCT01736696|Secondary|Gene Expression in Psoriatic Plaque Biopsies|Gene expression by quantitative polymerized chain reaction (PCR) using standard curve (SC) method generated by linear regression using log threshold cycle versus log(cell number). Keratin (K)-16, inducible nitric oxide synthase (iNOS), Interleukin 8 (IL-8), CD25, Granzyme B, IL-2, IL-7, IL-15, Interferon-gamma (INF-gamma), C-X-C motif chemokine(CXCL10), perforin 1, B-cell Lymphoma 2 (BCL-2), BCL2 associated X Protein (BAX), Tumor Necrosis Factor Fas Ligand (TNF-FasL), and proliferating cell nuclear antigen (PCNA) presented as control gene normalized expression (relative expression) within SC.|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.||relative expression unit (REU)||Standard Deviation|Mean
21828|NCT01736696|Secondary|Number of Participants With Physician’s Global Assessment (PGA) of Psoriasis|Physician global assessment (PGA) of Psoriasis is a 7-point scale used to assess severity of psoriatic plaques, scaling and/or erythema. Severity scale ranged from 1 to 7: 1=severe, 2=moderate to severe, 3=moderate, 4=mild to moderate, 5=mild, 6=almost clear, 7=clear (no sign of psoriasis).|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||participants|||Number
21829|NCT01736696|Secondary|Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14|Modified Psoriasis Area and Severity Index (mPASI) assessed lesion severity but not the body surface area affected. Severity was estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final mPASI = sum of the each component scores. Total score range 0-12 , higher score indicated more severity.|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||participants|||Number
21830|NCT01736696|Primary|Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)|EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.|Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL|||Number
21831|NCT01736696|Primary|Time to Reach Maximum Change From Baseline and Time to Return to Baseline Value for Fluorescence-Activated Cell Sorting (FACS), Reticulocyte Counts and Immune Cell Function||Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42|Data was not analyzed as per planned analyses due to pattern of changes observed.|||||
21832|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 42|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
21833|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 28|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
21834|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 21|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
21835|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 15|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 15|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
21836|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 10|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
21837|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 7|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
21838|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 4|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||1000 cells/mm^3||Standard Deviation|Mean
21839|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 2|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 2|Analysis population included all participants who met the eligibility criteria. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.||1000 cells/cubic millimeter (cells/mm^3)||Standard Deviation|Mean
21907|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|12 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
21841|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21842|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21843|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21844|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, Hour 0 on Day 18|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21845|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline; hr 0, 8 hr post-dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21846|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21847|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21848|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
22067|NCT01733953|Secondary|Change From Baseline in Augmentation Index at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||P2/P1||95% Confidence Interval|Mean
21849|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 2|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.||percent change||Standard Deviation|Mean
21850|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, 1 hr post-dose on Day 1|Analysis population included all participants who met the eligibility criteria.||percent change||Standard Deviation|Mean
21851|NCT01736696|Primary|Accumulation Ratio (R0)|Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Ratio||Standard Deviation|Mean
21852|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr||Full Range|Median
21853|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr||Full Range|Median
21854|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
21855|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
21856|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
21857|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
21858|NCT01736696|Primary|Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum QTc >=500 msec were reported.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.||participants|||Number
21859|NCT01736696|Primary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.||participants|||Number
21908|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|9 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
21860|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
21861|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
21862|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
21863|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
21864|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
21865|NCT01736696|Primary|Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.|Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14|Analysis population included all participants who met the eligibility criteria.||msec||Standard Deviation|Mean
21866|NCT01736696|Primary|Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.|8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||msec||Standard Deviation|Mean
21867|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||msec||Standard Deviation|Mean
21868|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||msec||Standard Deviation|Mean
21909|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|6 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
21869|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||msec||Standard Deviation|Mean
21870|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.||msec||Standard Deviation|Mean
21871|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.||millisecond (msec)||Standard Deviation|Mean
21872|NCT01736657|Secondary|Device-related Serious Adverse Events (SAE) in the Full Analysis Set|Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).|upon signing consent to 24 hours post-procedure|Seventy-three enrolled: 12 were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 patients), but these patients were included in safety analysis as Full Analysis Set; 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||participants|||Number
21873|NCT01736657|Secondary|Spectra Optia System’s Ability to Achieve the Desired Final Hematocrit in the Evaluable Population|Measurement of the patient post-procedure hematocrit compared to the final target hematocrit calculated by the Spectra Optia Apheresis System. Final target hematocrit was calculated by tracking the number of red cells coming into the system versus the number of red cells removed.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||ratio||95% Confidence Interval|Mean
21874|NCT01736657|Secondary|Procedural Success of the Spectra Optia System in the Evaluable Population|The procedural success of the Spectra Optia System is defined as the ability of the device to complete a red blood cell exchange (RBCx) and to obtain a satisfactory exchange by lowering the patient's hemoglobin S, as determined by the investigator in the evaluable population (60 pts).|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||percentage of participants|||Number
21875|NCT01736657|Primary|Mean Ratio Actual Fraction of Cells Remaining (FCRa; as Measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp; as Predicted by the Spectra Optia System FCR Algorithm Multiplied by the Pre-Procedure % HbS)|The primary endpoint evaluated the mean ratio of the Actual Fraction of Cells Remaining (FCRa: as measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp: as predicted by the Spectra Optia system FCR algorithm multiplied by the Pre-Procedure % HbS), in the evaluable population (60 pts). The pre-defined range for the mean ratio of the FCRa to the FCRp was 0.75 to 1.25.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.||ratio||95% Confidence Interval|Mean
21876|NCT01736579|Secondary|Volumetric MRI|Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21877|NCT01736579|Secondary|Time to Skilled Nursing Facility Placement|Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21878|NCT01736579|Secondary|Caregiver Burden Questionnaire|The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
24172|NCT01699022|Primary|MPA Pharmacokinetics Cmax|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem|85 days|||ng/mL||Standard Error|Mean
21879|NCT01736579|Secondary|Healthcare Resource Utilization Questionnaire (HRUQ)|The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21880|NCT01736579|Secondary|EQ-5D Questionnaire (Proxy Version)|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.~The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0].~Caregivers are asked to describe how they believe a participant would rate his/her health state that day."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21881|NCT01736579|Secondary|Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)|The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant’s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21882|NCT01736579|Secondary|Neuropsychiatric Inventory (NPI) Score|The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21883|NCT01736579|Secondary|Mini Mental State Examination (MMSE)|The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21884|NCT01736579|Secondary|Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21885|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)|The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21886|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at the site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.|||||
21887|NCT01736579|Primary|Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)||6 months|||infusions|Infusions||Number
21888|NCT01736579|Primary|Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months|||infusions|Infusions||Number
21889|NCT01736579|Primary|Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months|||infusions|Infusions||Number
21890|NCT01736579|Primary|Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months|||adverse events|||Number
21891|NCT01736540|Secondary|Investigator Treatment Decisions Based on MRI Results|"Treatment decisions were recorded after the investigator evaluated the MRI results, in order to assess the impact of such diagnostic test on the overall clinical management of participants with iron overload. Investigators answered the following question: Since the MRI scan, have you changed or are planning to change the management of iron in your subject?."|2 months|Participants, for whom treatment decision questionnaire results were provided and for whom MRI results were available, were included in the analysis.||Percentage of participants|||Number
21910|NCT01736475|Secondary|Changes in Lipid Panel Assessments From Screening – Cholesterol; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Triglycerides; and Very Low Density Lipoprotein (VLDL)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||mmol/L||Inter-Quartile Range|Median
24173|NCT01699022|Primary|MPA Pharmacokinetics|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem (AUC)|"Day 85"|||ng.day/mL||Standard Error|Mean
21892|NCT01736540|Secondary|Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy|"Adherence of participants was assessed using an adherence questionnaire. Adherence questionnaires were completed only by participants who received chelating agents. Participants answered yes or no to 6 statements such as Forgot to take pills. Based on the responses to these questions, adherence was classified as low, medium or high."|1 month|Participants who were on iron chelator therapy at screening, and had answered at least one question on the questionnaire and had sufficient information to score the questionnaire, were included in the analysis.||Percentage of participants|||Number
21893|NCT01736540|Secondary|Mean Quality of Life (QOL) Scores|Quality of life was assessed using the Short Form 36 (SF-36) Health Survey. The SF-36 consists of 8 sub-scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The raw sores of the 8 scales are transformed to a 0 - 100 scale where 0 indicates maximum disability and 100 indicates no disability. There also are two physical and mental health summary measures. Each summary measure is the mean average of the 4 associated sub-scale scores. The range for each summary measure is 0 to 100 where 0 represents maximum disability and 100 represents no disability.|1 month|Only participants with data for each subscale were included in the analysis for that subscale.||units on a scale||Standard Deviation|Mean
21894|NCT01736540|Secondary|Mean Number of Erythrocyte Units Transfused in Last 12 Months|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with 'number of units transfused' data were included in the analysis.||number of units transfused||Standard Deviation|Mean
21895|NCT01736540|Secondary|Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with data on time since their most recent transfusion were included in the analysis.||percentage of participants|||Number
21896|NCT01736540|Secondary|Percentage of Participants Transfused With Erythrocytes|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with a erythrocyte transfusion history were included in the analysis.||Percentage of participants|||Number
21897|NCT01736540|Secondary|Mean Blood Magnetic Susceptibility (BMS)|Blood samples were collected to assess BMS.|1 month|Participants with BMS values were analyzed.||emu/g wet wt/Oe||Standard Deviation|Mean
21898|NCT01736540|Secondary|Mean LIC According to the Presence or Absence of Retrospective Hepatic Events|Mean LIC according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with LIC by MRI were included in the analysis.||mg Fe/g||Standard Deviation|Mean
21899|NCT01736540|Secondary|Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events|Mean cardiac T2* according to the presence or absence of cardiac events was assessed for all participant subgroups. The mean data presented are mean estimates of log transformed data.|12 months - retrospective|Participants with valid T2* by MRI results were included in the analysis.||log10 (ms)||Standard Deviation|Mean
21900|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events|Mean serum ferritin according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous hepatic events data were included in the analysis.||ng/mL||Standard Deviation|Mean
21901|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events|Mean serum ferritin according to the presence or absence of cardiac events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous cardiac events data were included in the analysis.||ng/mL||Standard Deviation|Mean
21902|NCT01736540|Secondary|Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). The mean data presented are mean estimates of log transformed data.|2 months|Only participants with valid LIC by MRI were included in the analysis.||mg Fe/g||95% Confidence Interval|Mean
21903|NCT01736540|Secondary|Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups).|2 months|Only participants with valid T2* by MRI were included in the analysis.||ms||95% Confidence Interval|Least Squares Mean
21904|NCT01736540|Primary|Cardiac Siderosis Severity|Cardiac siderosis severity was measured by MRI (T2*). The severity grade of siderosis was tiered in 3 levels: mild (T2* >= 20ms), moderate (T2* from 10 to 20ms), and severe (T2* <10ms). Mild cardiac siderosis, by the definitions used in this study, were equivalent to not having cardiac siderosis. Values were compared to published thresholds of iron overload to determine severity of transfusion siderosis in the participant population studied.|2 months|Only participants with valid T2* by MRI were included in the analysis.||Percentage of participants|||Number
21905|NCT01736540|Primary|Percentage of Participants With Cardiac and Liver Iron Overload.|Hepatic iron overload (liver siderosis) and cardiac iron overload (cardiac siderosis) in patients with transfusional siderosis (Myelodysplastic syndrome (MDS), thalassaemia major, non-transfusion-dependent thalassaemia (NTDT) and other anaemias) were measured using MRI (R2 by FerriScan and T2*, respectively).|2 months|Only participants with valid T2* by MRI and valid liver iron concentration (LIC) by MRI were included for the cardiac siderosis and liver siderosis analyses, respectively.||Percentage of participants|||Number
21906|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|24 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.||μg/g||Standard Deviation|Mean
21911|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Erythrocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||TI/L||Inter-Quartile Range|Median
21912|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Hemoglobin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||g/L||Inter-Quartile Range|Median
21913|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Hematocrit||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||Percentage red blood cells||Inter-Quartile Range|Median
21914|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||giga (10^9) cells per liter (Gi/L)||Inter-Quartile Range|Median
21915|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Creatinine, and Bilirubin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||µmol/L||Inter-Quartile Range|Median
21916|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Bicarbonate, Chloride, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||mmol/L||Inter-Quartile Range|Median
21917|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase|Alkaline Phosphatase (Alk Phos); Alanine Aminotransferase (Ala Amino); Aspartate Aminotransferase (Asp Amino)|Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||Units per Liter||Inter-Quartile Range|Median
21918|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Albumin and Protein||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.||g/L||Inter-Quartile Range|Median
21919|NCT01736475|Secondary|Changes in Vital Signs From Screening - Blood Pressure|Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP)|Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||mmHg||Inter-Quartile Range|Median
21920|NCT01736475|Secondary|Change in Vital Signs From Screening - Respiratory Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||breaths per minute||Inter-Quartile Range|Median
21921|NCT01736475|Secondary|Change in Vital Signs From Screening - Pulse Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||beats per minute||Inter-Quartile Range|Median
21922|NCT01736475|Secondary|Change in Vital Signs From Screening - Temperature||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set||Celsius||Inter-Quartile Range|Median
21923|NCT01736475|Secondary|Pharmacokinetics (Pk) -Time to Maximum Concentration in Plasma (Tmax) (One-stage Clotting Assay)|Tmax in hours will be defined as the time to reach Cmax. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||hours||Standard Deviation|Mean
21924|NCT01736475|Secondary|Pharmacokinetics (Pk) - Maximum Plasma Concentration (Cmax) (One-stage Clotting Assay)|Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||IU/dL||Standard Deviation|Mean
21925|NCT01736475|Secondary|Pharmacokinetics (Pk) - Apparent Volume of Distribution at Steady State (Vss) (One-stage Clotting Assay)|"The apparent volume of distribution at steady state (Vss) will be calculated as: Vss = Clearance * Mean Residence Time.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||dL/kg||Standard Deviation|Mean
21926|NCT01736475|Secondary|Pharmacokinetics (Pk) - Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC0-∞) (One-stage Clotting Assay)|"Calculated by WinNonlin NCA (Model 201, calculation method: Linear Trapezoidal Linear/Log Interpolation).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||(IU*hours)/dL||Standard Deviation|Mean
21948|NCT01736215|Secondary|Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)|EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.||Participants|||Number
21927|NCT01736475|Secondary|Pharmacokinetics (Pk) - Incremental Recovery Over Time (One-stage Clotting Assay)|"Incremental recovery (IR) in (IU/dL)/ (IU/kg) calculated as: IR = (Cmax– (C pre-infusion)) / (Dose/kg), where C =concentration.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||(IU/dL)/(IU/kg)||Standard Deviation|Mean
21928|NCT01736475|Secondary|Pharmacokinetics (Pk) - Total Body Clearance (One-stage Clotting Assay)|"Clearance in dL/(kg.h) will be calculated as the dose in IU/kg divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||dL/(kg*hours)||Standard Deviation|Mean
21929|NCT01736475|Secondary|Pharmacokinetics (Pk) - Mean Residence Time (One-stage Clotting Assay)|"The mean residence time (MRT) w as calculated as total area under the moment curve divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||hours||Standard Deviation|Mean
21930|NCT01736475|Secondary|Pharmacokinetics (Pk) - Plasma Half-life (One-stage Clotting Assay)|"Terminal half-life calculated as log_e2/λz where λz is the terminal elimination rate constant.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)||hours||Standard Deviation|Mean
21931|NCT01736475|Secondary|Patient Reported Outcomes - Short Form (SF)-36, Change From Baseline to End of Study|Change from Baseline to End of Study for SF-36 Questionnaire is provided. Scores for individual SF-36 categories range from 0 to 100 with higher scores representing better health. Given that higher scores indicate better health-related quality of life (HRQoL) and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates a worsening of HRQoL.|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm]|Full Analysis Set - Subset of participants with both baseline and study completion SF-36 scores||Score on a scale||Standard Deviation|Mean
21932|NCT01736475|Secondary|Patient Reported Outcomes: Haemo-SYM Questionnaire, Change in Score From Baseline to End of Study|"The HAEMO-SYM has two subscales: pain and bleeds. HAEMO-SYM subscale scores are calculated by taking the mean of the items in each subscale and transforming them to a 0 (none or absent) to 100 (very severe) scale.~Given that higher scores indicate more severe symptoms on the Haemo-SYM and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates an improvement (reduction in symptoms). Conversely, a positive change score indicates worsening symptoms."|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm].|Full Analysis Set - Subset of participants with both baseline and study completion HAEMO-SYM scores||Score on a scale||Standard Deviation|Mean
21933|NCT01736475|Secondary|Immunogenicity - Number of Participants With Positive Inhibitory Antibodies to FVIII, Binding Antibodies to FVIII, PEG-VIII, PEG and Anti-CHO Antibodies at Study Completion/Termination|"Number of participants who received BAX855, with immunogenicity data from study completion/termination visit.~FVIII = factor VIII; PEG-VIII = polyethylene glycol-factor VIII; Anti-CHO = Anti-Chinese hamster ovary"|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm but did not receive BAX855 (only received ADVATE, during the screening period).||Participants|||Number
21934|NCT01736475|Secondary|Percentage of Participants With Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - All participants treated with BAX 855 were analyzed as a single group (ie on-demand and prophylaxis treatment regimens were analyzed as a single group).||percent of participants|||Number
21935|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Treatment of Bleeding Episode (BE) and Per BE for Maintenance of Hemostasis|Infusions per bleeding episode for maintenance of hemostasis only includes infusions following the resolution of a bleed to maintain hemostasis.|Treatment of Bleeding Episode (BE): Minor/Moderate BE every 12 to 24 hours until bleeding is resolved; Major BE every 8 to 12 hours until bleeding is resolved. Per BE for Maintenance of Hemostasis: within 48 hours after bleeding episode resolution.|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 for treatment of BEs (2) BAX855 for Maintenance of Hemostasis.~Subset of participants who received BAX855 for treatment of BEs: N= 92~Subset BAX855 for Maintenance of Hemostasis participants: N=16"||IU/kg|Participants|Standard Deviation|Mean
21936|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Prophylactic Infusion and Pharmacokinetic (PK) Infusion||Prophylactic Infusion: ≥50 exposure days or 6 months (±2 weeks), whichever occurs last. PK Infusion: PK #1 Pre-infusion within 30 minutes; Post-infusion 10 min, and 0.5, 1, 3, 6, 24, 32, 48, 56 hours (h). PK #2 also at Post-infusion 96h|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 prophylactic infusion or (2) BAX855 pharmacokinetic (PK) participants.~Subset of participants who received BAX855 prophylactic infusion: N= 120~Subset of BAX855 pharmacokinetic (PK) participants: N=26"||IU/kg|Participants|Standard Deviation|Mean
21937|NCT01736475|Secondary|Number of Participants With ≤1, 2, 3, 4, 5, 6, or >6 Month Time Intervals Between Bleeding Episodes or no Bleeding Episodes|Interval between Bleeds in months was calculated as: Observation period for efficacy (in days)/(number of bleeds)*(12/365.2425)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Study participants from the Full Analysis Set (FAS) who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm (thus was included in the FAS) and received only ADVATE during the screening period.||Participants|||Number
21938|NCT01736475|Secondary|Average Number of BAX 855 Infusions Needed for the Treatment of Bleeding Episodes||From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Participants from the Full Analysis Set who experienced at least one bleeding episode.||Infusions||Standard Deviation|Mean
21939|NCT01736475|Secondary|Rate of Success of BAX 855 for Treatment of Bleeding Episodes|Success in the control of bleeding was defined as a rating of excellent or good using the Efficacy Rating Scale for Treatment of Bleeding Episodes measured 24 hours after initiation of treatment for the bleeding episode. EXCELLENT: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusions to maintain hemostasis would not affect this scoring. GOOD: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. FAIR: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution. NONE: No improvement or condition worsens.|At least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm.|Full Analysis Set - All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens were analyzed as a single group.||Bleeding episodes|Participants|95% Confidence Interval|Number
21940|NCT01736475|Primary|Annualized Bleeding Rate (ABR)|Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.|9 months|Full Analysis Set||Bleeds per year||95% Confidence Interval|Least Squares Mean
21941|NCT01736215|Secondary|Transferring Iron Binding Capacity (TIBC)|TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Mcg per dl||Standard Deviation|Mean
21942|NCT01736215|Secondary|Serum Iron Level|Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluated for this outcome measure.||Microgram per deciliter (Mcg per dl)||Standard Deviation|Mean
21943|NCT01736215|Secondary|Serum Ferritin Level|Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Microgram per liter||Standard Deviation|Mean
21944|NCT01736215|Secondary|Reticulocyte Count|Reticulocytes are immature red blood cells.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluablated for this outcome measure and 'n' signifies participants who were evaluated for this outcome measure at given time point.||Nanogram per liter||Standard Deviation|Mean
21945|NCT01736215|Secondary|Serum Hematocrit Level|Hematocrit is the amount of red blood cells in the blood.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Percentage of red blood cells||Standard Deviation|Mean
21946|NCT01736215|Secondary|Serum Hemoglobin Level|Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.||Gram per deciliter (g per dl)||Standard Deviation|Mean
21947|NCT01736215|Secondary|Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4|CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.||Participants|||Number
22011|NCT01735214|Secondary|Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale|The physician evaluated the patient’s tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with data available for analysis.||percentage of participants|||Number
21949|NCT01736215|Primary|Percentage of Participants With Response to Erythropoietin Treatment|Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.|8 weeks|Participants who received erythropoietin treatment and had the data available at least on Baseline and at the end of study evaluation period.||Percentage of participants|||Number
21950|NCT01736176|Secondary|Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60|"Letter fluency was assessed using a paper and pen test, in which participants were asked to generate as many words as possible in 60 seconds, starting with the letters F, A, or S.~The COWAT All Letters score is the number of words recalled in all post-baseline assessments, regardless of letter used.~The COWAT Baseline Letter score is the number of words recalled in post-baseline assessments that used the same letter as at Baseline."|Baseline and Week 60|Efficacy dataset with available data||words||Standard Deviation|Mean
21951|NCT01736176|Secondary|Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data||units on a scale||Standard Deviation|Mean
21952|NCT01736176|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The between errors score is the number of times the participant revisited a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data||errors||Standard Deviation|Mean
21953|NCT01736176|Secondary|Change From Baseline in Health-related Productivity|"The Health-Related Productivity Questionnaire (HRPQ) is a generic measure of the impact of disease on the ability of the participant to be productive at paid employment or at performance of household chores. Questions inquire about the amount of time they were scheduled/planned to work, the number of the scheduled/planned hours they were able to work and their ability to be productive for the hours of work they did perform.~Absenteeism: Number of hours not worked due to PD or it's treatments;~Presenteeism: Number of hours of lost productivity while at work due to PD or it's treatments;~Total hours lost: Number of hours lost due to absenteeism and presenteeism"|Baseline, Week 12 and Week 60|Efficacy dataset with available data. Workplace hours lost is calculated for participants who were employed.||hours||Standard Deviation|Mean
21954|NCT01736176|Secondary|Treatment Satisfaction Questionnaire Scores|The Treatment Satisfaction Questionnaire (TSQ) is a single item instrument developed by the Sponsor on which the participant indicated their level of satisfaction or dissatisfaction with their PD treatment. The responses are recorded on a Likert-type scale (Very Satisfied, Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied).|Week 12 and Week 60|Efficacy dataset||Participants|||Count of Participants
21955|NCT01736176|Secondary|Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved|"The PGIC is a 7-point response scale. Participants were asked to rate their change in status using the following 7-point scale:~1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.~The responses of Very much improved, Much improved and Minimally improved on the PGIC were used to define responders."|Week 12 and Week 60|Efficacy dataset||percentage of participants|||Number
21956|NCT01736176|Secondary|Change From Baseline in PDQ-39 Bodily Discomfort Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21957|NCT01736176|Secondary|Change From Baseline in PDQ-39 Communication Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
22012|NCT01735214|Secondary|Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale|The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with available data.||percentage of participants|||Number
21958|NCT01736176|Secondary|Change From Baseline in PDQ-39 Cognition Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21959|NCT01736176|Secondary|Change From Baseline in PDQ-39 Social Support Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21960|NCT01736176|Secondary|Change From Baseline in PDQ-39 Stigma Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21961|NCT01736176|Secondary|Change From Baseline in PDQ-39 Emotional Well-Being Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21962|NCT01736176|Secondary|Change From Baseline in PDQ-39 Activities of Daily Living Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21963|NCT01736176|Secondary|Change From Baseline in PDQ-39 Mobility Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21964|NCT01736176|Secondary|Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 – 100 scale where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21965|NCT01736176|Secondary|Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The modified Hoehn and Yahr scale is as follows:~Stage 0: No signs of disease~Stage 1.0: Symptoms are very mild; unilateral involvement only~Stage 1.5: Unilateral and axial involvement~Stage 2: Bilateral involvement without impairment of balance~Stage 2.5: Mild bilateral disease with recovery on pull test~Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent~Stage 4: Severe disability; still able to walk or stand unassisted~Stage 5: Wheelchair bound or bedridden unless aided"|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21966|NCT01736176|Secondary|Change From Baseline in UPDRS Dyskinesia Items Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The dyskinesia items score includes questions 32, 33 and 34 from the complications of therapy section of the UPDRS which address dyskinesia duration, disability, and pain. Each question was answered on a scale from 0 (Normal) to 4 (Severe); the UPDRS dyskinesia items score was computed as the sum of these items and ranged from 0 (not affected) to 12 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21967|NCT01736176|Secondary|Change From Baseline in UPDRS Part IV: Complications of Therapy Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The complications of therapy section includes 11 items addressing dyskinesia duration, disability, and pain, early morning dystonia, “offs”-predictable, “offs”-unpredictable, “offs”-sudden, “offs”-duration, anorexia-nausea-vomiting, sleep disturbance, and symptomatic orthostasis. Four questions are answered on a scale from 0 (Normal) to 4 (Severe) and seven on a binary scale where 0=No and 1=Yes. The UPDRS Part IV: complications of therapy score was computed as the sum of these items and ranged from 0 (not affected) to 23 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21968|NCT01736176|Secondary|Change From Baseline in UPDRS Part III: Motor Examination Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The motor examination score includes 17 items addressing speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. Each question is answered on a scale from 0 (Normal) to 4 (Severe), some items include multiple grades for each extremity. The UPDRS Part III: motor examination score was computed as the sum of these items and ranged from 0 (not affected) to 108 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point||units on a scale||Standard Error|Least Squares Mean
21969|NCT01736176|Secondary|Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The activities of daily living score includes 13 items addressing speech, salivation, swallowing, handwriting, cutting food, dressing, hygiene, turning in bed, falling, freezing, walking, tremor, and sensory complaints. Each question is answered on a scale from 0 (Normal) to 4 (Severe). The UPDRS Part II: activities of daily living score was computed as the sum of these items and ranged from 0 (not affected) to 52 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point||units on a scale||Standard Error|Least Squares Mean
21970|NCT01736176|Secondary|Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The mentation, behavior, and mood score includes 4 items addressing intellectual impairment, thought disorder, motivation/initiative, and depression. Each question is answered on a scale from 0 (None) to 4 (Severe). The UPDRS Part I: mentation, behavior, and mood score was computed as the sum of these items and ranged from 0 (not affected) to 16 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point||units on a scale||Standard Error|Least Squares Mean
22013|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Right Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.||mmHg||Standard Deviation|Mean
22068|NCT01733953|Secondary|Change From Baseline in Pulse Wave Velocity at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||m/s||95% Confidence Interval|Mean
22069|NCT01733953|Secondary|Change From Baseline in Carotid Artery Distensibility at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||% distensibility||95% Confidence Interval|Mean
21971|NCT01736176|Secondary|Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The Total UPDRS score includes 31 items contributing to three subscales: (I) Mentation, Behavior, and Mood; (II) Activities of Daily Living; and (III) Motor Examination. Each question is answered on a scale from 0 (None) to 4 (Severe); Some questions require multiple grades assigned to each extremity. The UPDRS Total score was computed as the sum of these 3 UPDRS subscales and ranged from 0 to 176, with 176 representing the worst (total) disability, and 0 no disability."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point||units on a scale||Standard Error|Least Squares Mean
21972|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized On Time Without Troublesome Dyskinesia Based on PD Diary"|"The PD Diary was completed by the participant for 3 consecutive days prior to each visit. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from sleep.~On was defined as time when medication was providing benefit with regard to mobility, slowness, and stiffness. On time without troublesome dyskinesia is a composite of On time without dyskinesia (involuntary twisting, turning movements which are an effect of medication) plus On time with non-troublesome dyskinesia (dyskinesia that does not interfere with function or cause meaningful discomfort).~PD Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||hours||Standard Error|Least Squares Mean
21973|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized Off Time Based on Parkinson's Disease Diary"|"The Parkinson's Disease Diary was completed by the participant for 3 consecutive days prior to each visit for the full 24 hours of each day. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from time asleep.~Off time was defined as time when medication has worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness.~Parkinson's Disease Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||hours||Standard Error|Least Squares Mean
21974|NCT01736176|Secondary|Change From Baseline in NMSS Miscellaneous Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21975|NCT01736176|Secondary|Change From Baseline in NMSS Sexual Function Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21976|NCT01736176|Secondary|Change From Baseline in NMSS Urinary Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21977|NCT01736176|Secondary|Change From Baseline in NMSS Gastrointestinal Tract Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
22359|NCT01729026|Secondary|Patient Health Questionnaire-9 (PHQ-9)|Self-rating scale that assesses the presence and severity of the symptoms of a DSM-IV major depressive episode|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
21978|NCT01736176|Secondary|Change From Baseline in NMSS Attention/Memory Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21979|NCT01736176|Secondary|Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21980|NCT01736176|Secondary|Change From Baseline in NMSS Mood/Cognition Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21981|NCT01736176|Secondary|Change From Baseline in NMSS Sleep/Fatigue Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point||units on a scale||Standard Error|Least Squares Mean
21982|NCT01736176|Secondary|Change From Baseline in NMSS Cardiovascular Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS cardiovascular including falls domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time points||units on a scale||Standard Error|Least Squares Mean
21983|NCT01736176|Secondary|Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 60|Efficacy dataset with available data at baseline and week 60||units on a scale||Standard Error|Least Squares Mean
21984|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources Through Week 60|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The standard version of the questionnaire addressed the following questions over the last 3 months:~Has the subject had a visit to an emergency room?~Has the subject had an outpatient visit to any of the following healthcare providers?~Has the subject been visited in his or her place of residence by a health care professional?~Has the subject received assistance from either of the following for their Parkinson's disease in their home?~Has the subject needed to contact either of the following for immediate assistance related to their Parkinson's disease?~Have family members or friends had to miss any paid work due to the subject's Parkinson's disease?~Has the subject fallen during the past month?"|Week 60|Safety dataset with available data||Participants|||Count of Participants
22070|NCT01733953|Secondary|Change From Baseline in Carotid Artery Compliance at 6-Months|Carotid Artery Compliance is a measure of arterial stiffness. Higher arterial stiffness places persons at higher risk for CVD.|Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||mm/mmHg x 10^-3||95% Confidence Interval|Mean
21985|NCT01736176|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) related to treatment are those the investigator determined as having a reasonable possibility being related to study drug based on evidence to suggest a causal relationship between the study drug and the adverse event.~A severe AE was defined as an adverse event that caused considerable interference with the participant's usual activities and might be incapacitating or life-threatening.~Serious AEs were defined as those that were life-threatening or resulted in death, hospitalization or prolongation of hospitalization, a congenital anomaly, persistent or significant disability/incapacity, or important medical events requiring medical or surgical intervention to prevent a serious outcome."|Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days)|The Safety dataset||Participants|||Count of Participants
21986|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources During the First 4 Weeks|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The Week 4 version of the questionnaire addressed the following questions during the first four weeks after the PEG-J procedure:~Has the subject had a visit to an emergency room?~Has the subject had a visit to an urgent care?~Has the subject had an outpatient visit to a neurologist?~Has the subject had an outpatient visit to a gastroenterologist, surgeon, or interventional radiologist?~Has the subject had an outpatient visit to a primary care physician?~Has the subject called the nursing support line?~Has the subject called a physician?"|Weeks 1-4|The Safety dataset included all participants who underwent the PEG-J placement procedure||Participants|||Count of Participants
21987|NCT01736176|Primary|Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12|The Efficacy dataset included all participants who received at least 1 infusion of LCIG study drug and had a baseline and LCIG Treatment Period observation for at least one efficacy or health outcome measure.||units on a scale||Standard Error|Least Squares Mean
21988|NCT01735916|Secondary|Reverse Remodeling by Echocardiography|"The change in LVEF between study groups.~Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed."|Assessed from baseline visit to 24-month follow-up visit||||||
21989|NCT01735916|Secondary|Quality of Life (QoL)|"The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures.~Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.~Two QOL questionnaires were used in the study.~EQ-5D: scores typically range from 0-1, where higher scores reflect better quality of life KCCQ: scores range from 0-100, where higher scores reflect better quality of life"|Assessed from baseline visit to 24-month follow-up visit||||||
21990|NCT01735916|Secondary|Recurrent HF Events|"The frequency of HF events between the study groups~Note: No endpoints were reached, so this objective was not analyzed~- HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months||||||
21991|NCT01735916|Secondary|Mortality or Heart Failure Morbidity or Worsening Systolic Function|"Secondary Composite Efficacy Endpoint: The time to first event, with event defined as:~All-cause mortality~HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay, or~Worsening systolic function meeting an ICD/CRT-D indication, defined as:~A drop in LVEF to 35% or below, with an absolute decrease of greater than or equal to 10%, after maximum tolerated doses of guideline HF medications have been established~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months||||||
21992|NCT01735916|Secondary|Mortality|"Time to death between the study groups~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of death, for a minimum of 24 months and up to 60 months||||||
21993|NCT01735916|Primary|System-related Complication|"Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant.~Note: Because of the small number of subjects, number of complications was noted between arms and a time to event analysis was not performed.~Complication is defined as: An adverse event that results in death, involves any termination of significant device function, or requires an invasive intervention"|From the date of implant to the date of 6 month follow-up visit|||Complications|||Number
21994|NCT01735916|Primary|Mortality or Heart Failure Morbidity|"Primary Efficacy Endpoint: The time to first event, with event defined as:~All-cause mortality, or~HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months||||||
21995|NCT01735877|Secondary|Modified Rankin Scale (mRS)|"0 - No symptoms at all / 1 - No significant disability despite symptoms / 2 - Slight disability / 3 -Moderate disability, but able to walk without assistance / 4 - Moderate disability and unable to walk without assistance / 5 - Severe disability / 6 – death~0-2: Good outcome 3-6: Poor outcome"|Baseline, 1,3 and 6 months|||participants|||Number
21996|NCT01735877|Primary|Change From Baseline in Picture Identification Task at 1,3, and 6 Months|PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||pictures||95% Confidence Interval|Mean
21997|NCT01735877|Primary|Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months|"The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to ﬁnd and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign.~We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months.~The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months."|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||cms||95% Confidence Interval|Mean
21998|NCT01735877|Secondary|Functional Independence Measure|"The FIM consists of 13 motor and 5 social-cognitive items, assessing self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.14 It uses a 7-level scale anchored by extreme rating of total dependence as 1 and complete independence as 7; the intermediate levels are: 6 modiﬁed independence, 5 supervision or set-up, 4 minimal contact assistance, 3 moderate assistance and 2 maximal assistance.~For the purpose of analysis we divided FIM into two categories ≤5 dependent, ≥6 independent."|Baseline, 1, 3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||participants|||Number
21999|NCT01735877|Primary|Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months|"The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT.~Minimum score: 0 Maximum score: 54~Higher scores: better outcome"|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)||units on a scale||95% Confidence Interval|Mean
22000|NCT01735630|Secondary|Change From Baseline in ADCS-ADL Scores|The Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for ADCS-ADL Scores||units on a scale||Standard Error|Mean
22001|NCT01735630|Secondary|Change From Baseline in MMSE Scores|The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for MMSE Scores||units on a scale||Standard Error|Mean
22002|NCT01735630|Secondary|Change From Baseline in NPI Total Scores|The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144.|Week 12|mITT population with available data for NPI Total Scores||units on a scale||Standard Error|Mean
22003|NCT01735630|Secondary|Change From Baseline in Modified-ADCS-CGIC Agitation Scores|The Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation.|Week 12|mITT population with available data for Modified-ADCS-CGIC Agitation Scores||units on a scale||Standard Error|Mean
22004|NCT01735630|Primary|Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).|The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.|Week 12|mITT||units on a scale||Standard Error|Mean
22005|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Left Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.||mmHg||Standard Deviation|Mean
22006|NCT01735214|Secondary|Percentage of Participants Reaching Individual IOP Target After 12 Weeks||12 Weeks|All participants||percentage of participants|||Number
22007|NCT01735214|Secondary|Physician Assessment of Efficacy Using a 5-Point Scale|The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.|12 Weeks|All participants.||percentage of participants|||Number
22008|NCT01735214|Secondary|Physician Assessment of Adherence to New Treatment Using a 4-Point Scale|The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.|12 Weeks|All Participants||percentage of participants|||Number
22009|NCT01735214|Secondary|Percentage of Participants Who Continue the New Treatment After 12 Weeks||12 Weeks|All participants||percentage of participants|||Number
22010|NCT01735214|Secondary|Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks||12 Weeks|All participants.||percentage of participants|||Number
22014|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 1|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of participants|||Number
22015|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 0.5|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of participants|||Number
22016|NCT01735201|Primary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hours 2 to 12|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of participants|||Number
22017|NCT01734993|Secondary|Change From Baseline in CRP|Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||milligrams per liter (mg/L)||Standard Deviation|Mean
22018|NCT01734993|Secondary|Change From Baseline in ESR|Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||mm/hr||Standard Deviation|Mean
22019|NCT01734993|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity”. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||mm||Standard Deviation|Mean
22051|NCT01734655|Primary|Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1|||correlation coefficients|||Number
22101|NCT01733329|Primary|Need for Additional Uterotonic Medications|The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.|24 hours|||percentage of participants|||Number
22020|NCT01734993|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population, Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||Units on a scale||Standard Deviation|Mean
22021|NCT01734993|Secondary|Change From Baseline in Patient's Assessment of Pain|Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety Population. Here, 'n' represents the number of participants available for assessment at a given time point.||mm||Standard Deviation|Mean
22022|NCT01734993|Secondary|Change From Baseline in PtGA of Disease Activity|PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||mm||Standard Deviation|Mean
22023|NCT01734993|Secondary|Time to Concomitant Corticosteroid Dose Reduction|Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who had concomitant corticosteroid dose reduction.||Days||Full Range|Median
22024|NCT01734993|Secondary|Time to Concomitant Corticosteroid Discontinuation|Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here N (number of participants analyzed) represents the participants who discontinued concomitant corticosteroids||Days||Full Range|Median
22025|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Dose Reduction||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.||Percentage of participants|||Number
22026|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Discontinuation||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.||Percentage of participants|||Number
22027|NCT01734993|Secondary|Percentage of Participants With Clinical Remission|Clinical remission defined as:DAS28-ESR score < 2.6 and/or SDAI score </= 3.3.DAS28 score is measure of subject’s disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.|Week 48, 108|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given time point.||Percentage of participants|||Number
22028|NCT01734993|Secondary|Change From Baseline in SJC|For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||Swollen Joints||Standard Deviation|Mean
22052|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1|||correlation coefficients|||Number
22102|NCT01733277|Other Pre-specified|Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)||Baseline|||mg/L||Standard Deviation|Mean
22029|NCT01734993|Secondary|Change From Baseline in TJC|For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||Tender Joints||Standard Deviation|Mean
22030|NCT01734993|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.||Units on a scale||Standard Deviation|Mean
22031|NCT01734993|Secondary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score|The DAS 28 ESR score is a measure of the participant’s disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient’s global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.||Units on a scale||Standard Deviation|Mean
22032|NCT01734993|Primary|Percentage of Participants With Anti-TCZ Antibodies||Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
22033|NCT01734993|Primary|Percentage of Participants With Clinically Significant Laboratory Abnormalities|Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
22034|NCT01734993|Primary|Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities|Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (<) 40 beats per minute and value greater than (>) 150 beats per minute, systolic blood pressure (SBP) of < 80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or > 40 degrees Celsius, respiratory rate of <10 or > 50 breaths/minute and criteria for PCI change in physical examination: >/=10% increase or decrease of body weight in kilograms (kg).|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
22035|NCT01734993|Primary|Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.|Baseline up to approximately 142 weeks|Safety Population||Percentage of participants|||Number
22036|NCT01734993|Primary|Percentage of Participants With AESIs Related to TCZ|AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
22037|NCT01734993|Primary|Percentage of Participants With Adverse Events of Special Interest (AESIs)|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
22038|NCT01734993|Primary|Percentage of Participants With AEs and SAEs Related to TCZ|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
22039|NCT01734993|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.|Baseline up to approximately 142 weeks|Safety population||Percentage of participants|||Number
22040|NCT01734889|Secondary|The Palatability Scores on Day 3 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.||units on a scale||Full Range|Median
22041|NCT01734889|Secondary|The Palatability Scores on Day 2 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 2|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.||units on a scale||Full Range|Median
22042|NCT01734889|Secondary|The Palatability Scores on Day 1 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 1|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.||units on a scale||Full Range|Median
22043|NCT01734889|Primary|The Acceptability Score for the Last Dose of the Suspension on Day 3 for Subjects < 5 Years|The parents of patients aged <5 years rated their child´s acceptability of the suspension. The following grading was applied: 5 (very well), 4 (well), 3 (neither well nor badly), 2 (badly) and 1 (very badly).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments||units on a scale||Full Range|Median
22044|NCT01734889|Primary|The Taste Score for the Last Dose of the Suspension on Day 3 for Subjects 5 - <18 Years|Patients rated the taste of the suspension. The following grading was applied: 5 (very good taste), 4 (good taste), 3 (neither good nor bad taste), 2 (bad taste) and 1 (very bad taste).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments||units on a scale||Full Range|Median
22045|NCT01734785|Secondary|Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment|Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)||kg||Standard Error|Least Squares Mean
22046|NCT01734785|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)||mmol/L||Standard Error|Least Squares Mean
22047|NCT01734785|Primary|HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment|Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term ‘baseline’ was not used to refer to measurements before the administration of open-label medication.|Baseline and 24 weeks|The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.||Percentage of HbA1c||Standard Error|Least Squares Mean
22048|NCT01734772|Primary|Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
22049|NCT01734772|Primary|Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
22050|NCT01734655|Primary|Correlation of the MEQ Subscales to the MAAS|The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level|V1|||correlation coefficients|||Number
22053|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.||correlation coefficients|||Number
22054|NCT01734655|Primary|To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a|"Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a high value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency)."|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.||Ratio of Variance|||Number
22055|NCT01734655|Primary|Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)|Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.|SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits|||test-retest coefficent|||Number
22056|NCT01734395|Secondary|Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)|MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients’ cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria||Units on a scale||Standard Deviation|Mean
22057|NCT01734395|Primary|Change From Baseline at Week 16 in Burden Interview (BI) Scores|BI is designed to evaluate subjective stress dementia patients’ caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.||Units on a scale||Standard Deviation|Mean
22058|NCT01734395|Primary|Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)|AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant’s attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.|Baseline (Week 1 [Day 1]), Week 16|FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.||Units on a scale||Standard Deviation|Mean
22059|NCT01734317|Secondary|Pain|Pain before, during and after dressing removal will be meausered.|After 14/21 days treatment||||||
22060|NCT01734317|Primary|Efficacy|Healing at day 14. Healing was defined as ≥95% epithelialisation.|14 days|||participants|||Number
22061|NCT01734239|Primary|Number of Participants Reporting Serious Adverse Experiences|A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention|Up to Day 28 postvaccination|The All Subjects as Treated population included all enrolled participants||Number of participants|||Number
22062|NCT01734239|Primary|Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.|Up to Day 14 postvaccination|The All Subjects as Treated population included all enrolled participants||Number of participants|||Number
22063|NCT01734239|Primary|Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)||Up to 5 days postvaccination|The All Subjects as Treated population included all enrolled participants||Number of participants|||Number
22064|NCT01734239|Primary|Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.|Day 28 postvaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range||Percentage of participants||95% Confidence Interval|Number
22065|NCT01734239|Primary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays|Prevaccination and Day 28 after vaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range||ug/mL||95% Confidence Interval|Mean
22066|NCT01733953|Secondary|Change From Baseline in Carotid Intima-Media Thickness at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.||mm||95% Confidence Interval|Mean
22071|NCT01733953|Primary|Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months||Baseline and 6-Months|Physician withdrawals, loss to follow-up, drug compliance <70%, unrelated injury, and self-withdrawal reduced number analyzed. Also, participant movement during FMD assessment and/or poor ultrasound image quality due to difficult brachial artery anatomy or poor circulation led to some unusable data and thus lowered the analyzable sample size.||percentage change||95% Confidence Interval|Mean
22072|NCT01733758|Secondary|Time to Study Withdrawal for Any Reason|Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.|Baseline through Week 52|Intent-to-Treat Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least one post-Baseline assessment (scheduled or unscheduled) of the primary endpoint, HbA1c.||Weeks||95% Confidence Interval|Median
22073|NCT01733758|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.|Baseline through Week 52|Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.||Weeks||95% Confidence Interval|Median
22074|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.||Kilograms (kg)||Standard Deviation|Mean
22075|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 24|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.||Kilograms (kg)||Standard Deviation|Mean
22076|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
22077|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
22078|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.||Percentage of participants|||Number
22079|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.|Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.||Percentage of participants|||Number
22080|NCT01733758|Secondary|Change From Baseline in HbA1c at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.||Percentage of HbA1c in the blood||Standard Deviation|Mean
22127|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||mm Hg||Standard Deviation|Mean
22081|NCT01733758|Primary|Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.||Percentage of HbA1c in the blood||Standard Deviation|Mean
22082|NCT01733758|Primary|Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
22083|NCT01733745|Secondary|Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses|The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.||units on a scale|Participants|Standard Deviation|Mean
22084|NCT01733745|Secondary|Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses|The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.||units on a scale|Participants|Standard Deviation|Mean
22085|NCT01733745|Primary|Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)|Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.||functioning glands|Participants|Standard Deviation|Mean
22086|NCT01733732|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) by Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||mmHg|Participants|Standard Deviation|Mean
22087|NCT01733732|Secondary|Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit|Dry eye status was assessed using the Schirmer’s test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||millimeters|Participants|Standard Deviation|Mean
22088|NCT01733732|Secondary|Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||percentage of cells||Standard Deviation|Mean
22100|NCT01733329|Secondary|Uterine Atony|Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, “boggy” uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.|24 hours|||percentage of participants|||Number
22089|NCT01733732|Secondary|Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit.||percentage of cells|Participants|Standard Deviation|Mean
22090|NCT01733732|Secondary|Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30|A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||pg/mL||Standard Deviation|Mean
22091|NCT01733732|Secondary|Mean Change From Baseline in Ocular Surface Staining by Visit|Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||units on a scale|Participants|Standard Deviation|Mean
22092|NCT01733732|Secondary|Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit|TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||millimeters|Participants|Standard Deviation|Mean
22093|NCT01733732|Secondary|Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit|NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||seconds|Participants|Standard Deviation|Mean
22094|NCT01733732|Secondary|Meibomian Gland Expression|Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||units on a scale|Participants|Standard Deviation|Mean
22095|NCT01733732|Secondary|Percentage of Eyes With Normal Slit-lamp Assessment|An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.||percentage of eyes|Participants||Number
22096|NCT01733732|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit|BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."||LogMAR||Standard Deviation|Mean
22097|NCT01733732|Primary|Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit|The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
22098|NCT01733329|Secondary|Blood Loss||24 hours|||mL||Standard Deviation|Median
22099|NCT01733329|Secondary|Postpartum Hemorrhage|"Defined as:~Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion"|24 HOURS|||percentage of patients|||Number
22360|NCT01729026|Secondary|MINI International Neuropsychiatric Inventory (MINI)|Semi-structured interview used to assess the presence of 15 common DSM-IV psychiatric diagnoses.|Baseline||||||
22103|NCT01733277|Secondary|Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain|The WOMAC measures pain (score range 0–20), stiffness (score range 0–8), and functional limitation (score range 0–68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.|Baseline|||units on a scale||Standard Deviation|Mean
22104|NCT01733277|Primary|Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain||Baseline|Number of participant analyzed Per-protocol||participants|||Number
22105|NCT01733069|Primary|APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type|Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)|Baseline|Results for 4 gender-specific sample types were reported for 2 targets (CT, Chlamydia trachomatis; and GC, Neisseria gonorrhoeae infection). In this observational study, 1313 females (143 CT and/or GC-infected) and 549 males (121 CT and/or GC infected) contributed to one or more analyses.||participants|||Number
22106|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against pandemic H1N1 strains before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days|||participants|||Number
22107|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against H3N2 Perth before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days|||participants|||Number
22108|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||l/min/m^2||Standard Deviation|Mean
22109|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||l/min/m^2||Standard Deviation|Mean
22110|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||l/min||Standard Deviation|Mean
22111|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||l/min||Standard Deviation|Mean
22112|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||percentage of blood volume||Standard Deviation|Mean
22113|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||percentage of blood volume||Standard Error|Mean
22114|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||ml||Standard Deviation|Mean
22115|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||ml||Standard Deviation|Mean
22116|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||ml||Standard Deviation|Mean
22117|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||ml||Standard Deviation|Mean
22118|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||cm||Standard Deviation|Mean
22119|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||cm||Standard Deviation|Mean
22120|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||cm||Standard Deviation|Mean
22121|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||cm||Standard Deviation|Mean
22122|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||g||Standard Deviation|Mean
22123|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||g||Standard Deviation|Mean
22124|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||mm Hg||Standard Deviation|Mean
22125|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.||mm Hg||Standard Deviation|Mean
22126|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.||mm Hg||Standard Deviation|Mean
22128|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 2 Years|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years|Participants with an evaluation of this measure.||participants|||Number
22129|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 6 Months|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months|Participants with an evaluation of this measure.||participants|||Number
22130|NCT01732835|Secondary|Aortic Insufficiency (AI) at 2 Years|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years|Participants with an echocardiogram evaluable for this measure.||participants|||Number
22131|NCT01732835|Secondary|Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure||2 years|||percentage of participants||95% Confidence Interval|Number
22132|NCT01732835|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|6 months|||percentage of participants||95% Confidence Interval|Number
22133|NCT01732835|Secondary|Implant Procedure Success|Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.|discharge or 14 days postprocedure, whichever comes first|||percentage of implant procedures||95% Confidence Interval|Number
22134|NCT01732835|Primary|Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months|Participants with an echocardiogram evaluable for this measure.||participants|||Number
22135|NCT01732835|Primary|Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure||6 months|||percentage of participants||95% Confidence Interval|Number
22136|NCT01732796|Secondary|SVR24|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).|24 Week (post-treatment)|FAS||Percantage of participants|||Number
22137|NCT01732796|Secondary|SVR4|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).|4 Week (post-treatment)|FAS||Percentage of participants|||Number
22138|NCT01732796|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS||Percentage of participants|||Number
22139|NCT01732796|Primary|SVR12 Rates With Historical Control|Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint|12 Week (post-treatment)|The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).||Percentage of participants|||Number
22140|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).||percent change||95% Confidence Interval|Least Squares Mean
22141|NCT01732770|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).||percent change||95% Confidence Interval|Least Squares Mean
22142|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis|BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).||percent change||95% Confidence Interval|Least Squares Mean
22143|NCT01732770|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis|Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set includes all randomized participants who have a baseline BMD measurement and at least one postbaseline BMD measurement. Any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, last observation carried forward [LOCF]).||percent change||95% Confidence Interval|Least Squares Mean
22144|NCT01732757|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22145|NCT01732757|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22146|NCT01732757|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22147|NCT01732757|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22148|NCT01732757|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22149|NCT01732757|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22150|NCT01732757|Secondary|Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0|Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).|Day 0|All randomized subjects with data at this time point||Percentage of Subject Eyes|Participants||Number
22151|NCT01732757|Secondary|Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.|Day 0|All randomized subjects with data at this time point||Percentage of Subjects|||Number
22152|NCT01732757|Secondary|Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.|Day 0|All randomized subjects with data at this time point||Percentage of Subjects|||Number
22153|NCT01732757|Secondary|Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22154|NCT01732757|Primary|Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0 at 3 Minutes Post Challenge|All randomized subjects with data at this time point||Scores on a Scale||Standard Deviation|Mean
22155|NCT01732692|Secondary|Percentage of Patients Who Experienced Adverse Events (AEs)|An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.|From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.|Safety population||percentage of participants|||Number
22156|NCT01732692|Secondary|Patient Compliance – Amount of Additional Clear Liquid Consumed|To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.|1 day (the day of colonoscopy)|Intent-to-treat population with available data||ml||Standard Deviation|Mean
22157|NCT01732692|Secondary|Total Compliance Score|"Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).~Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre."|1 day (the day of colonoscopy)|Intent-to-treat with available data||units on a scale||Standard Deviation|Mean
22158|NCT01732692|Secondary|Patient Satisfaction of Colonoscopy Preparation (VAS)|"Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as totally unacceptable (lowest patient satisfaction of colonoscopy preparation) and 100 is fully acceptable (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant."|1 day (the day of colonoscopy)|Intent-to-treat population with available VAS data.||units on a scale||Standard Deviation|Mean
22159|NCT01732692|Primary|Percentage of Participants With Successful Colon Cleansing|Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.|1 day (the day of colonoscopy)|Intent-to-treat population||percentage of participants|||Number
22160|NCT01732588|Secondary|OZ439 Tmax|Time of maximum observed plasma drug concentrations (Tmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."||hours||Full Range|Median
22161|NCT01732588|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
22162|NCT01732588|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
22163|NCT01732549|Secondary|Safety Profile of Tasquinimod|Number of subjects reporting adverse events|At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)|Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received||participants|||Number
22164|NCT01732549|Secondary|Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score|"Baseline is defined as last measurement collected prior to the first dose of study drug. End of Study visit (within 14 days of last dose of study treatment)~The EQ-5D, a 5-item scale useful in health resource utilisation and cost comparisons between treatment groups designed for self-completion by patients consists of two pages [EQ-5 descriptive system and EQ Visual Analogue Scale(VAS)]. The EQ-5 descriptive system comprises five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS. The respondents are asked to mark health status on the day of the interview on a 10cm vertical scale with end points of 0 to100. There are notes at the both ends of the scale that the bottom rate(0) corresponds to the worst health you can imagine, and the highest rate(100) corresponds to the best health you can imagine"|Baseline and End-of-study Visit (approximately up to 2.5 years)|ITT population||Score on scale||Inter-Quartile Range|Median
22165|NCT01732549|Secondary|Time to Deterioration in Functional Assessment of Cancer Therapy – Prostate (FACT-P)|"End of Study visit (within 14 days of last dose of study treatment)~Impact of tasquinimod on health related quality of life (QoL) - Analysis of time to deterioration in FACT-P~The FACT-P measurement system is a validated collection of health related quality of life (HRQOL) questionnaires used to assess HRQOL in men with prostate cancer. It is appropriate for use with patients with any form of cancer and extensions of it have been used and validated in other chronic illness condition. The FACT-P is a self-administered 39-item scale comprising five domains: physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns. The individual subscale scores range from 0 to a high between 24 and 48 and the total score ranges between 0 and 156, with higher scores representing better Quality of Life (QoL)"|Up to End of Study visit (approximately up to 2.5 years)|ITT population||weeks||90% Confidence Interval|Median
22166|NCT01732549|Secondary|Time to Further Anticancer Treatment for Prostate Cancer|Time from randomisation to further treatment for prostate cancer|Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)|ITT population||weeks||90% Confidence Interval|Median
22167|NCT01732549|Secondary|Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death|"Symptomatic PFS is defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first [symptomatic progression as assessed by Brief Pain Inventory (BPI) and analgesic use].~Symptomatic progression was defined by the occurrence of pain with documented disease, skeleton related adverse events.~The median symptomatic PFS for placebo and tasquinimod groups was not reached.~Tasquinimod: Patients censored = 48, Patients at risk (t=0) = 71 Placebo: Patients censored = 54, Patients at risk (t=0) = 73"|Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)|ITT Population||participants|||Number
22194|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Sub-population of Responders|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Sub-population of responders included participants with reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.||percent change||Standard Deviation|Mean
22168|NCT01732549|Secondary|Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)|"The time from the date of randomisation to the date of radiological progression free survival [PFS] on next-line therapy (PFS 2) or death due to any cause.~Radiological progression was defined~- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions~- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)|ITT Population||weeks||90% Confidence Interval|Median
22169|NCT01732549|Secondary|Overall Survival Based on Number of Subjects Who Died|"Overall survival is defined as the time from randomisation to death due to any cause.~The number of participants who died is presented since the Median was not reached for this assessment.~Tasquinimod: Patients censored = 63, Patients at risk (t=0) = 71 Placebo: Patients censored = 67, Patients at risk (t=0) = 73"|Every 3 months after study treatment stop until death (approximately up to 2.5 years)|ITT Population||participants|||Number
22170|NCT01732549|Primary|Time to Radiological Progression Free Survival [PFS]|"The time from the date of randomisation to the date of radiological progression or death due to any cause.~Radiological progression was defined~- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions~- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 8 weeks until disease progression documentation (approximately up to 2.5 years)|Intention to treat (ITT) Population||weeks||90% Confidence Interval|Median
22171|NCT01732510|Secondary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation|Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).|Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224|The ADA evaluable population defined as all participants with at least one ADA sample available after treatment with MK-8226 or placebo was used for analysis.||Participants|||Number
22172|NCT01732510|Secondary|Percentage of Participants With >=50% Improvement in EASI Score|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22173|NCT01732510|Other Pre-specified|Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2|Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22174|NCT01732510|Secondary|Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2|Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.|Up to Week 12|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22175|NCT01732510|Secondary|Change From Baseline in Participant Sleep Disturbance in Study Part 2|Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22176|NCT01732510|Secondary|Change From Baseline in Participant Pruritus in Study Part 2|Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22195|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Overall Population|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.||percent change||Standard Deviation|Mean
22352|NCT01729247|Primary|FeNO Values by ACT Score|Scores on an asthma control test (ACT) of <=19 indicates less well controlled asthma, scores >19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.|Study Visit (single visit study). Approximately 1 hour.|||parts per billion (ppb)||Standard Deviation|Mean
22177|NCT01732510|Secondary|Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2|The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant’s subjective score.|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22178|NCT01732510|Secondary|Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2|Percentage of participants achieving an IGA of atopic dermatitis of “clear-0” or “almost clear-1”. The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).|Baseline, Week 4, Week 8, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22179|NCT01732510|Secondary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 4, Week 8, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22180|NCT01732510|Secondary|Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration|t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (t1/2) from at least one treatment was used for analysis.||days||Geometric Coefficient of Variation|Geometric Mean
22181|NCT01732510|Secondary|Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration|Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (Vd) from at least one treatment was used for analysis.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
22182|NCT01732510|Secondary|Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration|CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (CL) from at least one treatment was used for analysis.||mL/day/kg||Geometric Coefficient of Variation|Geometric Mean
22183|NCT01732510|Secondary|Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration|Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (Cmax) from at least one treatment was used for analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
22196|NCT01732471|Primary|Percentage of Participants With Response to Kuvan® (Sapropterin Dihydrochloride) Treatment|Response to Kuvan® (sapropterin dihydrochloride) treatment was defined as a reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.|Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.||percentage of participants||95% Confidence Interval|Number
22353|NCT01729026|Secondary|Numeric Rating Scale for Pain Intensity|Self-rating scale that assesses pain severity|Baseline and 3-month and 6-month follow-up||||||
22184|NCT01732510|Secondary|AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration|AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (AUC0-last) from at least one treatment was used for analysis.||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
22185|NCT01732510|Secondary|Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration|AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The Per-Protocol (PP) population defined as all participants compliant with study procedure with data available (AUC0-tau) from at least one treatment was used for analysis.||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
22186|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2|CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22187|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2|CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from Baseline [BL] in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.|||||
22188|NCT01732510|Primary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1|Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12|The Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of study treatment with baseline and at least one post-dose assessment (EASI) was used for analysis.||Score on a scale||Standard Deviation|Mean
22189|NCT01732510|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 12 Weeks|The ASaT population defined as all participants who received at least one dose of investigational drug was used for analysis.||participants|||Number
22190|NCT01732510|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 32 Weeks|The All Subjects as Treated (ASaT) population defined as all participants who received at least one dose of investigational drug was used for analysis.||participants|||Number
22191|NCT01732484|Secondary|Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy|Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values|3 years|||percentage of eyes|Participants||Number
22192|NCT01732484|Primary|Posterior Capsule Opacification (PCO)|PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)|3 years|||units on a scale (0-10)||Standard Deviation|Mean
22193|NCT01732471|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Overall Safety Population|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 11|Overall safety population included all participants who received at least 1 dose of investigational medicinal product.||participants|||Number
22354|NCT01729026|Secondary|Veterans RAND 12-item Health Survey (VR-12)|Self-rating scale that assess physical and mental aspects of health-related quality of life|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
22197|NCT01732263|Primary|Volume of Distribution (Vz/F) of SSP-004184|The distribution of a medication between plasma and the rest of the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||L/kg||Standard Deviation|Mean
22198|NCT01732263|Primary|Total Body Clearance (CL/F) of SSP-004184|The rate at which a drug is removed from the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||L/h/kg||Standard Deviation|Mean
22199|NCT01732263|Primary|Plasma Half-Life (T 1/2) of SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||hours||Standard Deviation|Mean
22200|NCT01732263|Primary|Time of Maximum Plasma Concentration (Tmax) for SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||hours||Full Range|Median
22201|NCT01732263|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
22202|NCT01732263|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ng*h/ml||Standard Deviation|Mean
22203|NCT01731470|Secondary|Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)|Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.|4 and 8 weeks post-treatment|||units on a scale||Inter-Quartile Range|Mean
22204|NCT01731470|Primary|Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score|The O’Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.|4 and 8 weeks post-treatment|||units on a scale||Inter-Quartile Range|Median
22205|NCT01731041|Secondary|P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12|Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.|4 hours|||PRU||Standard Error|Least Squares Mean
22206|NCT01731041|Primary|Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment|4 hours|||PRI%||Standard Error|Least Squares Mean
22207|NCT01730378|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (From Day 0 to 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
22208|NCT01730378|Secondary|Number of Subjects Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
22209|NCT01730378|Secondary|Number of Subjects Reporting Unsolicted AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 84-day (Days 0-83) post vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
22273|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
22210|NCT01730378|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21 days (Day 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
22211|NCT01730378|Secondary|Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).|Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (From Day 0 to Day 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
22212|NCT01730378|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C|During the 7-day (Days 0-6) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
22213|NCT01730378|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Day 0-6) period after each vaccination|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
22214|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
22215|NCT01730378|Secondary|Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
22216|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
22217|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Days 0 and 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
22218|NCT01730378|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
22219|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
22355|NCT01729026|Secondary|UCLA Loneliness Scale, Version 3|Self-rating scale to assess symptoms of loneliness|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up||||||
22220|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
22221|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
22222|NCT01730378|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
22223|NCT01730378|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
22224|NCT01730378|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
22225|NCT01730378|Primary|Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 42|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subjects|||Number
22226|NCT01730339|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.||participants|||Number
22227|NCT01730339|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest|Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.|Baseline up to Week 24|"Safety population included all participants who received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||participants|||Number
22228|NCT01730339|Other Pre-specified|Number of Participants With Electrocardiogram Findings|Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.|Baseline, Week 11|"Safety population included all participants who received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."||participants|||Number
22229|NCT01730339|Other Pre-specified|Number of Participants With Abnormal Physical Examinations|Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.||participants|||Number
22230|NCT01730339|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.||participants|||Number
22231|NCT01730339|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
22232|NCT01730339|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
22233|NCT01730339|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
22234|NCT01730339|Secondary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."||units on scale||Standard Error|Least Squares Mean
22235|NCT01730339|Primary|Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)|Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant’s scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 24|Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||units on scale||Standard Error|Least Squares Mean
22236|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
22237|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Fasting triglycerides ITT population.||percent change||Standard Error|Mean
22238|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
22239|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Lipoprotein (a) ITT population.||percent change||Standard Error|Mean
22240|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22241|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
22242|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22243|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
22274|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
22244|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
22245|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
22246|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
22247|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
22248|NCT01730053|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
22249|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
22250|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
22251|NCT01730053|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22252|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
22253|NCT01730053|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22254|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.||percent change||Standard Error|Least Squares Mean
22255|NCT01730053|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22256|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
22257|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
22361|NCT01729026|Secondary|Community Integration Questionnaire (CIQ)|Self-rating scale that assesses the extent of a subject's integration into her or his community|Baseline and 3-month and 6-month follow-up visits||||||
22258|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
22259|NCT01730053|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22260|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
22261|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
22262|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
22263|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Lipoprotein (a) ITT population.||percent change||Standard Error|Mean
22264|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22265|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.||percent change||Standard Error|Mean
22266|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22267|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
22268|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
22269|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
22270|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
22271|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
22272|NCT01730040|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
22275|NCT01730040|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22276|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
22277|NCT01730040|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22278|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.||percent change||Standard Error|Least Squares Mean
22279|NCT01730040|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22280|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|mITT population.||percent change||Standard Error|Least Squares Mean
22281|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
22282|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
22283|NCT01730040|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
22284|NCT01729871|Secondary|Number of Participants With Vascular Death|Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
22285|NCT01729871|Secondary|Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism|The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
22286|NCT01729871|Secondary|Number of Participants With Ischemic Stroke|Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
22356|NCT01729026|Secondary|Semi-Structured Interview|Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls||||||
22357|NCT01729026|Secondary|Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)|Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD|Baseline and 3-month and 6-month follow-up||||||
22287|NCT01729871|Secondary|Number of Participants With Myocardial Infarction (MI)|The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site’s upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
22288|NCT01729871|Secondary|Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death|The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
22289|NCT01729871|Primary|Number of Participants With Incidence of Post-Procedure Major Bleeding Events|Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.||Participants|||Number
22290|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity|A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children N=27 at Visit 1 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at visit)."||U/L||Standard Deviation|Mean
22291|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity|The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 3: N=16 one participant with missing data at this visit)."||U/L||Standard Deviation|Mean
22292|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity|The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visit 1: N=27 (1 participant missing); Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at this visit)."||U/L||Standard Deviation|Mean
22293|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Protein Concentration|The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||g/L||Standard Deviation|Mean
22294|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity|Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visits 1 and 3: N=26 and at Visit 2 N=24 participants; Young and Very Young Children Group at Visits 1 and 3: N=16 participant with missing data)."||U/L||Standard Deviation|Mean
22303|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triglycerides Concentration|Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant data missing; Older children Visits 2 and 3: N=27 and N=26 one and two participant data missing; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant data missing)."||mmol/L||Standard Deviation|Mean
22295|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration|Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents-Visit 2 & 3: N=20 - 1 participant with data missing; Older Children-Visit 1 & 2: N=26 thus 2 participants with data missing; Young and Very Young Children-Visits 1 & 3: N=12 (5 with data missing) & at Visit 2 N=9 (8 with data missing)."||µmol/L||Standard Deviation|Mean
22296|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity|The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 2: N=16 one participant with missing data)."||U/L||Standard Deviation|Mean
22297|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity|This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=19 two participants with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||U/L||Standard Deviation|Mean
22298|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test|A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."||units on a scale||Standard Deviation|Mean
22299|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine Specific Gravity|This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."||units on a scale||Standard Deviation|Mean
22300|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate|Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mL/min/1.73m^2||Standard Deviation|Mean
22301|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urate in the Blood|Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||µmol/L||Standard Deviation|Mean
22302|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration|Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children N=27 at Visit 1; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||g/L||Standard Deviation|Mean
22304|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity|AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visits 2 and 3: N=26 two participants with missing data; Young and Very Young Children Group at Visits 1 and 3: N=16 one participant with missing data)."||U/L||Standard Deviation|Mean
22305|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatinine Concentration|Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||µmol/L||Standard Deviation|Mean
22306|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration|This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
22307|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration|Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
22308|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration|Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
22309|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration|All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
22310|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration|Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
22311|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration|Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
22312|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration|A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."||mmol/L||Standard Deviation|Mean
22313|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Leukocyte Concentration|Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each visit)."||GI/L||Standard Deviation|Mean
22314|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Platelet Count|Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||GI/L||Standard Deviation|Mean
22315|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)|Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||fL||Standard Deviation|Mean
22316|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||fraction of blood volume||Standard Deviation|Mean
22317|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hemoglobin Concentration|The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."||g/L||Standard Deviation|Mean
22318|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||hours||Standard Deviation|Mean
22319|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||nanogramsg/millilitre||Standard Error|Mean
22320|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||ng*hr/mL||Full Range|Mean
22358|NCT01729026|Secondary|Physical Activity Questionnaire (PAQ)|Self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months.|Baseline and 3-month and 6-month follow-up||||||
22321|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||hours||Standard Deviation|Mean
22322|NCT01729728|Secondary|Intake of Additional Analgesic Medication During the Trial|Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).|Baseline; 15 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.||participants|||Number
22323|NCT01729728|Secondary|Treatment Emergent Adverse Events by Intensity|"The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.~The clinical “intensity” of an adverse event was classified as:~Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.~Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.~Severe: Symptoms which affect usual daily activity.~For adverse events where the intensity changes over time, the maximum intensity observed was documented."|Baseline; 48 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.||number of events|||Number
22324|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample"|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||nanograms/millilitre||Standard Error|Mean
22325|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter|"12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.~The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.~A positive value indicates that the heart rate was higher at discharge than at enrollment."|Enrollment; Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(For older children: N=27 at Visit 1)"||beats per minute||Standard Deviation|Mean
22326|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Parameters|"12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.~The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities."|Enrollment (pre-surgery); Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(For older children N=27 at Visit 1)"||milliseconds||Standard Deviation|Mean
22327|NCT01729728|Secondary|Systolic and Diastolic Blood Pressure Assessments|"Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."||mmHg||Standard Deviation|Mean
22328|NCT01729728|Secondary|Oxygen Saturation Assessments|"Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."||percentage of oxygen saturation||Standard Deviation|Mean
22329|NCT01729728|Secondary|Respiratory Rate Assessments|"Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, and at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."||breaths per minute||Standard Deviation|Mean
22330|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.~The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.~The area is that below the line fitted to the data points."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.||ng*hr/mL||Full Range|Mean
22331|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22332|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22333|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22334|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22335|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22336|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22337|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22338|NCT01729728|Secondary|Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups|"Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.~Adolescents - Age 12 to Less Than 18 Years.~Older Children - Age 6 to Less Than 12 Years.~Young Children - Age 3 to Less Than 6 Years.~Very Young Children - Age 2 to Less Than 3 Years.~CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],~VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],~FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],~FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].~A mean score of zero indicates that there was no pain intensity change over the 4 hours.~The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period."|Baseline; 4 hours post-dose|Protocol pre-specified reporting groups.||units on a scale||Standard Deviation|Mean
22339|NCT01729728|Secondary|Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).|The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.|Baseline; 15 hours post-dose|The protocol pre-specified that the young and very young children will be reported as one group.||units on a scale||Standard Deviation|Mean
22340|NCT01729728|Secondary|Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.|"This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.~The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.~The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician."|Baseline; 15 hours post-dose|The protocol pre-specified that the Faces Pain Scale (Revised) would not be administered in the very young participants (aged 2 to less than 3 years).||units on a scale||Standard Deviation|Mean
22341|NCT01729728|Secondary|Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).|Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.|Baseline; 15 hours post-dose|Protocol pre-specified reporting groups.||units on a scale||Standard Deviation|Mean
22342|NCT01729728|Secondary|Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).|"At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:~“My pain at this time is”. The mark was scored between “no pain” and ” pain as bad as it could be”. The distance was then measured by a clinician and reported.~A value of 0 indicates no pain. A value of 100 indicates pain as bad as it could be."|Baseline; 15 hours|Protocol pre-specified reporting groups.||units on a scale||Standard Deviation|Mean
22343|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|||nanogram per milliliter||Standard Deviation|Mean
22344|NCT01729559|Secondary|Heparin Induced Thrombocytopenia|The possible occurrence of heparin induced thrombocytopenia (HIT) was investigated when any patient (in either low molecular weight heparin [LMWH] or low dose unfractionated heparin [LDUH] study arm) had a platelet count drop of ≥50% (from a baseline value at the time of initiation of VTE prophylaxis) between day 5 and 14 following initiation of chemoprophylaxis per American College of Chest Physicians (ACCP) guidelines.|Within 30 of admission to hospital|||participants|||Number
22345|NCT01729559|Secondary|Bleeding Event|Bleeding events will be classified by the Graafsma et al. severity of bleeding criteria (Major, Minor or No Bleeding). A major bleeding event will be defined as any overt bleeding following initiation of chemoprophylaxis associated with one or more of the following; a decrease in hemoglobin of ≥2 g/dL, bleeding leading to a transfusion of ≥2 units of packed red blood cells, a new retroperitoneal or intracranial bleed, or bleeding that warranted cessation of chemoprophylaxis treatment. Minor bleeding is defined as clinically evident bleeding not meeting criteria for major bleeding.|Within 30 days of admission to hospital|||participants|||Number
22346|NCT01729559|Primary|Pulmonary Embolus|Patients with any or all of the following signs and symptoms suggestive of pulmonary embolism will have a CT angiogram (CTA) performed for diagnosis: Sudden onset of dyspnea, deterioration of existing dyspnea, decreased oxygen saturation (<92%), onset of pleuritic chest pain without another apparent cause, onset of tachycardia (>100), evidence of hypoxemia, hypocapnia, or respiratory alkalosis on arterial blood gas, or electrocardiographic changes reflecting right ventricular strain.|Within 30 days from admission to hospital|||participants|||Number
22347|NCT01729559|Primary|Lower Extremity Deep Vein Thrombosis|Patients will have a bilateral lower extremity duplex ultrasound performed by a registered vascular technologist twice per week if the patient is in the ICU, or once per week if the patient is on the trauma ward. All of the deep veins from the external iliac to and including the calf veins will be interrogated. Diagnosis of deep vein thrombosis (DVT) will be defined as absence of complete vein compressibility, presence of an echogenic thrombus within the vein, absence of color flow characteristics including lack of spontaneity, phasicity, pulsatility and augmentability as noted in the clinical practice guidelines of the American Thoracic Society. The vascular technologist and physician reading the ultrasound study will be blinded to the patient's enrollment status and randomization arm/medication group.|Within 30 days of hospital admission|||percentage of patients|||Number
22348|NCT01729247|Secondary|Asthma Management Changes After FeNO Results Were Considered|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).|Study visit (single visit study). Approximately1 hour.|||participants|||Number
22349|NCT01729247|Secondary|Number of Participants Correctly Categorized by True Level of Airway Inflammation|Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.|Study visit (single visit study) approximately 1 hour.|||participants correctly categorized|||Number
22350|NCT01729247|Secondary|Physician Assessment of Airway Inflammation|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).|Study visit (single visit study) approximately 1 hour|||parts per billion (ppb)||Standard Deviation|Mean
22351|NCT01729247|Primary|FeNO Categorical Levels by ICS Use|Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (<25 ppb), intermediate (>=25 to <=50 ppb) and high (>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.|Study visit (single visit study). Approximately1 hour.|||participants|||Number
22364|NCT01729026|Secondary|Clinician-Administered PTSD Scale for DSM-5 (CAPS)|The administration of the CAPS will ensure that participants meet criteria for current PTSD|The CAPS will be administered at the baseline, 3-month, and 6-month follow-ups.||||||
22365|NCT01729026|Primary|Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up|PCL-5 a self rating scale based on the DSM-5 diagnostic criteria. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).|Baseline and 3-month follow-up visit.|||units on a scale||Standard Error|Mean
22366|NCT01728792|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 28, 90 and 120 after 1st vaccination|Protocol deviations results in testing not performed for outcome measure.|||||
22367|NCT01728792|Secondary|Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations|"Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. n in each of the categories is the number of participants with data available."|Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.||participants|||Number
22368|NCT01728792|Primary|Seroconversion Rate to Each of Four Dengue Serotypes|Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)|Protocol deviations results in testing not performed for outcome measure.|||||
22369|NCT01728792|Primary|Number of Participants With at Least 1 Serious Adverse Event During the Study|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|First Vaccination to End of Study (Up to Day 120)|Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
22370|NCT01728792|Primary|Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
22371|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity|Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
22372|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity|Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
22373|NCT01728792|Primary|Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator|Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.||participants|||Number
22374|NCT01728584|Secondary|Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm|Post operative use of pain/analgesic medication by participant through Day 8 was recorded.|Up to Day 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||participants using pain medication|||Number
22375|NCT01728584|Secondary|Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||Standard Deviation|Mean
22376|NCT01728584|Secondary|Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||Standard Deviation|Mean
22377|NCT01728584|Secondary|Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||Standard Deviation|Mean
22378|NCT01728584|Secondary|Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm|During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a “rescue intervention”), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||participants|||Number
22379|NCT01728584|Secondary|Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): How did the patient movements described above disrupt your surgical performance? This refers to participant movements during surgery."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
22380|NCT01728584|Secondary|Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)|At the end of the procedure the surgeon responds to the following question: “How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?”|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||instances of occurrence that interfered||95% Confidence Interval|Least Squares Mean
22381|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
22817|NCT01721096|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|1 year post index procedure|||percentage of participants|||Number
22382|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
22383|NCT01728584|Secondary|Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): How satisfied were you overall with the visual field during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
22384|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant’s overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||95% Confidence Interval|Least Squares Mean
22385|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant’s overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.||score on a scale||95% Confidence Interval|Least Squares Mean
22386|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a acale||95% Confidence Interval|Least Squares Mean
22387|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.||score on a scale||95% Confidence Interval|Least Squares Mean
22388|NCT01728376|Secondary|Maximum Plasma Concentration (Cmax) of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at end of infusion|Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.||µg/mL||Standard Deviation|Mean
22389|NCT01728376|Secondary|Trough Plasma Concentration of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day’s end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at pre-dose|Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.||µg/mL||Standard Deviation|Mean
22390|NCT01728376|Secondary|Percentage of Participants With Overall Success at TOC Visit|Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.||Percentage of participants|||Number
22391|NCT01728376|Secondary|Percentage of Participants With Clinical Success at TOC/Safety Visit|Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.||Percentage of participants|||Number
22392|NCT01728376|Primary|Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)|Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.|TOC Safety Visit (up to 56 days)|Participants who received any dose of IV study medication.||Participants|||Number
22393|NCT01728376|Primary|Percentage of Participants With Sustained CPK Elevations|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)|Baseline up to end of therapy visit (up to 44 days)|Participants who received any dose of IV study medication||Percentage of Participants|||Number
22394|NCT01728376|Primary|Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .|Baseline up to end of therapy visit (up to 49 days)|Participants who received any dose of IV study medication||Percentage of Participants|||Number
22395|NCT01728376|Primary|Number of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication||Participants|||Number
22396|NCT01728376|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication||Participants|||Number
22397|NCT01728337|Secondary|Maximum Evoked Compound Muscle Action Potential|To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.|5 months after the procedure.|All subjects have received both treatments.||mV||Standard Deviation|Mean
22398|NCT01728337|Primary|Percentage of Responders After 5 Months After the Procedure|Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score at maximum contraction compared to the WSS score at baseline.|5 months after intervention|80 sujbects were included in this study, each patient have received both products in their faces. The randomization was performed to define the side for each product.||percentage of participants|||Number
22399|NCT01728324|Secondary|Prognostic Value of SVR12 Predicting SVR24|The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.|24 Week (post-treatment)|FAS||Percentage of participants|||Number
22400|NCT01728324|Secondary|SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.|4 weeks (after End Of Treatment)|FAS||percentage of participants||95% Confidence Interval|Number
22401|NCT01728324|Secondary|SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.|4 weeks (after End Of Treatment)|FAS||percentage of participants||95% Confidence Interval|Number
22402|NCT01728324|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS||Percentage of participants||95% Confidence Interval|Number
22403|NCT01728324|Primary|SVR12 Rates With Historical Control|"Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.~The number of participants analyzed are actually adjusted number of participant analyzed."|12 Week (post-treatment)|Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;||percentage of participants|||Number
22404|NCT01728246|Primary|Time to Discontinuation Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|Time to discontinuation because of rescue medication was not analyzed, because dates when the rescue medication was given were not properly filled out in the forms, hence the exact time to discontinuation because of rescue medication could not be determined or analyzed.|||||
22405|NCT01728246|Primary|Percentage of Participants Who Discontinued Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.||percentage of participants|||Number
22406|NCT01728246|Primary|Change From Baseline in ODI Score at Week 4|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 4 (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.||units on a scale||Standard Deviation|Mean
22407|NCT01728246|Primary|Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 2|Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score.|||||
22408|NCT01728246|Primary|Change From Baseline in VAS-pain Score at Week 4|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 4 Last Observation Carried Forward (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.||mm||Standard Deviation|Mean
22409|NCT01728246|Primary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2|VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 2|Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.||mm||Standard Deviation|Mean
22410|NCT01728116|Secondary|Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months||Baseline and 12 Months|mITT population without imputation||percentage of participants|||Number
22411|NCT01728116|Secondary|Diastolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation||mmHg||Standard Deviation|Mean
22412|NCT01728116|Secondary|Systolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation||mmHg||Standard Deviation|Mean
22413|NCT01728116|Secondary|Fasting Glucose Change From Baseline||Baseline and 12 Months|mITT population without imputation||mg/dL||Standard Deviation|Mean
22414|NCT01728116|Secondary|Triglycerides Change From Baseline||Baseline and 12 Months|mITT population without imputation||mg/dL||Standard Deviation|Mean
22415|NCT01728116|Secondary|LDL Change From Baseline||Baseline and 12 Months|mITT without imputation||mg/dL||Standard Deviation|Mean
22416|NCT01728116|Secondary|Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months||Baseline and 12 Months|mITT population without imputation||percentage of participants|||Number
22417|NCT01728116|Secondary|Assessment of Total Cholesterol Change at 12 Months Compared to Baseline||Baseline and 12 Months|mITT population without imputation||mg/dL||Standard Deviation|Mean
22418|NCT01728116|Primary|Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE|Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.|Baseline and 12 Months|mITT without Imputation||percentage of participants||95% Confidence Interval|Number
22419|NCT01728116|Primary|Primary Efficacy Endpoint: Improvement in HbA1c|Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation|Baseline and12 months|All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.||Percentage of HbA1c||Standard Deviation|Mean
22420|NCT01727895|Secondary|the Composition of Faecal Microbiota||Days 0, 6, 21||||||
22421|NCT01727895|Secondary|• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).||Days 0, 6, 21||||||
22422|NCT01727895|Secondary|• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)||Days 0, 6, 21||||||
22423|NCT01727895|Secondary|• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.||Days 0, 6, 21||||||
22424|NCT01727895|Secondary|• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA||Days 0, 6, 21||||||
22425|NCT01727895|Secondary|• Production of Other Cytokines (TNF-α, Interleukin (IL)-6, IL-10, IL-1β, IL-17, IL-22, Interferon (IFN)-γ) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)||days 0, 6, 21||||||
22426|NCT01727895|Primary|Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)|The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response|up to 21 days|||pg/ml||Inter-Quartile Range|Median
22427|NCT01727791|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.||participants|||Number
22428|NCT01727791|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.||participants|||Number
22429|NCT01727791|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.||participants|||Number
22430|NCT01727791|Primary|Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)|Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||percentage of dose||Full Range|Mean
22431|NCT01727791|Primary|Body Weight Normalized Maternal Dose (BWNMD)|Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/kg/day||Full Range|Mean
22432|NCT01727791|Primary|Body Weight Normalized Infant Dose (BWNID)|Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/kg/day||Full Range|Mean
22433|NCT01727791|Primary|Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)|Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||ratio||Full Range|Mean
22434|NCT01727791|Primary|Milk to Plasma Ratio for AUCtau (MPAUCtau)|MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||ratio||Full Range|Mean
22435|NCT01727791|Primary|Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)|Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg||Full Range|Mean
22436|NCT01727791|Primary|Renal Clearance (CLr)|Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mL/min||Geometric Coefficient of Variation|Geometric Mean
24174|NCT01699022|Primary|MPA Concentrations|Assessment of mean trough levels of MPA on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and 'Day 85"|||ng/mL||Standard Deviation|Mean
22437|NCT01727791|Primary|Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)|Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
22438|NCT01727791|Primary|Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)|Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mg||Geometric Coefficient of Variation|Geometric Mean
22439|NCT01727791|Primary|Breast Milk Clearance (CLbm)|Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mL/min||Geometric Coefficient of Variation|Geometric Mean
22440|NCT01727791|Primary|Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)|Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
22441|NCT01727791|Primary|Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)|Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg||Geometric Coefficient of Variation|Geometric Mean
22442|NCT01727791|Primary|Average Breast Milk Concentration During the Dosing Interval (Cav)|Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Full Range|Mean
22443|NCT01727791|Primary|Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])|The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Standard Deviation|Mean
22444|NCT01727791|Primary|Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])|Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Full Range|Median
22445|NCT01727791|Primary|Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])|Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
22446|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])|AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
22447|NCT01727791|Primary|Apparent Oral Clearance (CL/F)|Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mL/minute||Geometric Coefficient of Variation|Geometric Mean
22448|NCT01727791|Primary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
22449|NCT01727791|Primary|Average Plasma Concentration During the Dosing Interval (Cav)|Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
22450|NCT01727791|Primary|Plasma Half-Life (t1/2)|Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Standard Deviation|Mean
22451|NCT01727791|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was the time to peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||hr||Full Range|Median
22452|NCT01727791|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was the peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
22453|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The pharmacokinetic (PK) parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.||microgram*hour/milliliter (mcg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
22454|NCT01727713|Secondary|Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).|The treatment discontinuation rate was calculated as the number of discontinued participants (ie, those withdrawn from the study without completing the Week 52 visit) divided by the number of all enrolled participants.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Percentage of discontinued participants|||Number
22455|NCT01727713|Secondary|Percentage of Participants With Response (Response Rate).|Clinical response was defined as > 25% improvement from Baseline to endpoint in YGTSS TTS or a CGI-TS change score of 1 (very much improved) or 2 (much improved) at endpoint.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Percentage of participants with response|||Number
22456|NCT01727713|Secondary|Mean Change From Baseline to Endpoint in Total YGTSS Score.|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) for motor and vocal tics, and an impairment ranking. The YGTSS TTS is the summation of the severity scores of motor and vocal tics (range of 0 [no impairment] to 50 [maximum impairment]). The total YGTSS score is the summation of the severity scores of motor and vocal tics and the ranking of impairment (total range of 0 [no impairment] to 100 [maximum impairment]).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
22457|NCT01727713|Secondary|Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.|The final CGI-TS score was compared to the participant’s baseline condition at the time of entry into the open-label study, rather than the CGI-TS baseline condition at the time participants enrolled into the preceding study. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
22458|NCT01727713|Secondary|Mean Clinical Global Impressions for Tourette’s Syndrome (CGI-TS) Change Score at Endpoint.|The CGI is a 7-point Likert scale used in a multitude of clinical trials as a clinical global measure to assess the severity and change in disease symptomatology (ie, tics). The CGI was included as a secondary scale to provide a more complete assessment of clinical efficacy. To assess CGI-TS severity, the rater or investigator will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” However, the evaluation of illness will be limited to manifestations of Tourette’s Disorder only. Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
22466|NCT01727713|Primary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score.|The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of 1 representing absence of symptoms, and a score of 5 representing a severe condition. The SAS total score (range 10 to 50) was the sum of the rating scores for 10 items from the SAS panel.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
24090|NCT01700348|Secondary|Percentage of Bleeding Sites|Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks||||||
22459|NCT01727713|Secondary|Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).|The YGTSS is a semi-structured clinical interview which consists of a tic inventory, with 5 separate ratings to assess the number, intensity, frequency, complexity and interference of tics, plus an overall impairment/disability score. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the secondary outcome measure in this trial. The YGTSS ranking of impairment, with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. The total severity score ranged from 0 (no impairment) to 50 (worst impairment).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
22460|NCT01727713|Primary|Change From Baseline in Pediatric Anxiety Rating Scale (PARS).|The PARS is used to rate the severity of anxiety in children and adolescents, aged 6 to 17 years. The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child’s repertoire of symptoms during the past week. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score was the sum of items 2, 3, 5, 6, and 7. The total severity score ranged from 0 (no anxiety) to 25 (worst anxiety).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
22461|NCT01727713|Primary|Change From Baseline in Children’s Depression Rating Scale - Revised (CDRS-R).|The CDRS-R is a brief rating scale based on a semi-structured interview with the child and an adult informant who knows the child well. Designed for 6- to 12-year-old children, and successfully used with adolescents, it can be administered in 15 to 20 minutes. The interviewer rates 17 symptom areas (including those that serve as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for a diagnosis of depression): impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
22462|NCT01727713|Primary|Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS).|The CY-BOCS is a semi-structured interview used with children and adolescents aged 6 to 17 years to rate the severity and type of symptoms in participants with obsessive compulsive disorder. In general, the items depend on the participant's report; however, the final rating is based on the clinical judgment of the interviewer and should include additional information supplied by others. Nineteen items are rated in the CY-BOCS, but only items 1 through 10 (excluding items lb and 6b) are used to determine the total score. The total CY-BOCS score is the sum of items 1 through 10 (excluding lb and 6b), whereas the obsession and compulsion subtotals are the sums of items 1 through 5 (excluding lb) and 6 through 10 (excluding 6b), respectively. CY-BOCS total score could range from 0 to 40, and the obsession and compulsion subscale total scores could each range from 0 to 20. Higher scores indicate worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
22463|NCT01727713|Primary|Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).|The SNAP-IV Rating Scale is a revision of the SNAP Questionnaire. The SNAP-IV assesses inattention and hyperactivity/impulsivity, as well as oppositional defiant disorder that are often present in children with ADD/ADHD. The SNAP-IV was administered as a semi-structured interview with the participant and caregiver. The SNAP-IV is based on a 0 to 3 rating scale: not at all = 0, just a little = 1, quite a bit = 2, and very much = 3. The ADD/ADHD subscale includes items 1 through 19 (items 1–9 measure inattention, items 11–19 measure hyperactivity/ impulsivity, and item 10 for inattention domain), items 4, 8, 11, 31, and 32 measure inattention/overactivity, and items 21, 23, 29, 34, and 35 measure aggression/defiance. Items 4, 8, 11, 21, 32, 33, 36, 37, 38, and 39 form the Conners Index. Subscale average scores on the SNAP IV were calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
22464|NCT01727713|Primary|Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).|The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline/“since last visit” evaluation that focuses on suicidality since the last trial visit. The C-SSRS data at Baseline and post baseline were summarized for incidence of reporting: Suicidality, Suicidal behavior (and its 4 types), Suicidal ideation (and its 5 types). The intensity score of each item ranges from 1 (least severe) to 5 (most severe), which leads to the range of the total score from 0 to 25.|Baseline, Weeks 1, 2, 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
22465|NCT01727713|Primary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.|The BARS Global Score is derived from the global clinical evaluation of akathisia on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
22501|NCT01727024|Secondary|Number of Participnats With Difficulties Experienced When Handling the Devices|Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.|1 week|The safety analysis set, which included participants who received at least one dose of study medication, was considered for the analysis. However, only participants who had observed values, were analyzed.||Participants|||Number
22467|NCT01727713|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.|The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest, and the investigator also made global judgments on the participant's dyskinesias (items 8 through 10). Each item was rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness/severe distress). In addition, the AIMS included 2 yes/no questions that addressed the subject’s dental status (since an edentulous state can cause lingual dyskinesias). The AIMS movement rating score (range 0 to 28) was the sum of the rating scores for facial and oral moments (ie, items 1 to 4), extremity movements (ie, items 5 and 6), and trunk movements (ie, item 7).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Units on a scale||Standard Deviation|Mean
22468|NCT01727713|Primary|Mean Change From Baseline in Waist Circumference.|Waist circumference was measured at Baseline, Weeks 12, 28, 36, 44, and the Week 52/last visit in centimeters.|Baseline to Weeks 12, 28, 36, 44, and 52/last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline waist circumference measurement.||Centimeter||Standard Deviation|Mean
22469|NCT01727713|Primary|Mean Change From Baseline in Body Mass Index (BMI).|BMI was calculated at the Baseline visit (using the Baseline height from study 31-12-293) and at Weeks 28 and 52/ET where height measured at baseline in the current trial was used to calculate BMI.|Baseline to Weeks 28, 52 and Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline BMI measurement.||Kg/M^2||Standard Deviation|Mean
22470|NCT01727713|Primary|Mean Change From Baseline in Body Weight.|Criteria for identifying weight of potential clinical relevance was: ≥ 7% kilogram increase/decrease from Baseline (Final visit of Trial 31-12-293).|Baseline to Weeks 12, 28, 36, 44, 52/Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline weight measurement.||Kilogram||Standard Deviation|Mean
22471|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).|Three 12-lead ECGs (scheduled 5 minutes apart) were recorded. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: Tachycardia/sinus tachycardia: increase of ≥15 bpm from Baseline; increase in QTc of ≥10% from Baseline. The other abnormalities not present at Baseline and were present during the time of measurement were recorded. Percentage of participants noted with abnormal ECG findings are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline ECG result were included.||Percentage of participants|||Number
22472|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Vital Signs.|Vital sign measurements included systolic and diastolic blood pressure (BP) and heart rate, which were performed at all clinic visits. Criteria for identifying vital signs of potential clinical relevance included: Heart rate: ≥ 15 beats per minute (bpm) increase/decrease from Baseline (final visit of study 31-12-293); Systolic BP: ≥ 20 mmHg increase/decrease from Baseline; Diastolic BP: ≥ 15mmHg increase/decrease from Baseline; Orthostatic hypotension: ≥ 20 mmHg decrease in systolic BP and a ≥ 25 bpm increase in heart rate from supine to sitting/standing. Percentage of participants noted with abnormal vital sign measurements are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline vital sign result were included.||Percentage of participants|||Number
22473|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.|Laboratory tests including hematology, serum chemistry, and urinalysis were performed for all the participants. The central laboratory was used for all laboratory testing whenever possible. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant based on the pre-defined criteria for identifying laboratory values of potential clinical relevance. Percentage of participants noted with abnormal laboratory values are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline laboratory value were included.||Percentage of participants|||Number
22474|NCT01727713|Primary|Percentage of Participants With Adverse Events.|An AE is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the study drug. A treatment emergent adverse event (TEAE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to have a causal relationship with the study drug. Serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolonged hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.|Baseline, throighout the 52-week treatmetn and 30±3 days after last trial visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.||Percentage of participants|||Number
22475|NCT01727700|Secondary|Treatment Discontinuation Rate|Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment.||Percentage of participants|||Number
22476|NCT01727700|Secondary|Response Rate|Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Percentage of Responders|||Number
22825|NCT01721096|Secondary|Success Rate: Implant Success by Patient||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants||95% Confidence Interval|Number
22477|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score|The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
22478|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
22479|NCT01727700|Secondary|Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.|To assess CGI-TS severity, the rater or physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
22480|NCT01727700|Primary|Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).|The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.|Baseline to Week 8|Intent-to-Treat (ITT) Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.||Units on a scale||Standard Error|Least Squares Mean
22481|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
22482|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
22483|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
22502|NCT01727024|Secondary|Number of Participants With Preference for Either Device|Participants answered a single question to determine their device preference.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed.||Participants|||Number
22504|NCT01727024|Secondary|Number of Participants Correctly Using the Device After One Week of Handling|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed.||Participants|||Number
22484|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
22485|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
22486|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
22487|NCT01727180|Primary|Visual Analog Scale (VAS)|A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable|Once at the entry of the study|||units on a scale||Standard Deviation|Mean
22488|NCT01727167|Secondary|Compare Blood to Right Atrial Tissue Biochemical Markers of Mitochondrial Biogenesis|Biochemical markers in both right atrial tissue and blood will be measured and compared to see if the more easily obtained blood markers accurately describe changes expected in the heart.|on week|Molecular data was not collected for the single enrolled participant.|||||
22489|NCT01727167|Primary|Biochemical Markers for Mitochondrial Biogenesis (Blood and Right Atrial Tissue)|Right atrial biochemical markers will be measured one time only, intra-operatively. Blood Biochemical markers will be measured before CO exposure and at intervals up to one week post-operatively|2 weeks|Molecular data was not collected for the single enrolled participant.|||||
22490|NCT01727141|Secondary|Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
22491|NCT01727141|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||Number of puffs||Standard Error|Least Squares Mean
22492|NCT01727141|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
22493|NCT01727141|Secondary|Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, week 12|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
22503|NCT01727024|Secondary|Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire|"Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.~The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction"|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed.||score on a scale||Standard Deviation|Mean
22494|NCT01727141|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
22495|NCT01727141|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
22496|NCT01727141|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||Liters||Standard Error|Least Squares Mean
22497|NCT01727141|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 – 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
22498|NCT01727141|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
22499|NCT01727141|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.||score on a scale||Standard Error|Least Squares Mean
22500|NCT01727141|Primary|Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.||Liter||Standard Error|Least Squares Mean
22818|NCT01721096|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|8 months post index procedure|||percentage of participants|||Number
22505|NCT01727024|Primary|Number of Participants Who Correctly Used the Device at the Start of Handling the Device|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 1|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed.||Participants|||Number
22506|NCT01726621|Primary|User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.|Four weeks of pump wear|||units on a scale||Standard Deviation|Mean
22507|NCT01726517|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.~Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement."|Baseline to Posttreatment Week 24|||percentage of participants|||Number
22508|NCT01726517|Secondary|Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set||percentage of participants|||Number
22509|NCT01726517|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.|Baseline to Week 12|Safety Analysis Set||participants|||Number
22510|NCT01726517|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug||percentage of participants|||Number
22511|NCT01726504|Secondary|Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40–60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks|||percentage of participants|||Number
22512|NCT01726504|Secondary|The Number of Participants Using Rescue Medicine for Constipation||1-20 weeks|||participants|||Number
22513|NCT01726504|Secondary|Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40–60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks|||number of times per week||Standard Error|Mean
22514|NCT01726504|Secondary|Number of Participants With Adverse Events Related to Acupuncture||1-8 weeks|||participants|||Number
22515|NCT01726504|Secondary|Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)|Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.|baseline and the end of 8th week|||score on a scale||Standard Error|Mean
22516|NCT01726504|Secondary|Change of Average Weekly Degree of Difficulty in Defecation From Baseline|"The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.~0 = not at all~= more straining than not~= a great deal~= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline"|Baseline and weeks 1-8|||scores on a scale||Standard Error|Mean
22517|NCT01726504|Secondary|Mean Scores for Stool Consistency and Straining During Weeks 1–8|average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.|Baseline and weeks 1-8|||score on a scale||Standard Error|Mean
22518|NCT01726504|Secondary|Mean Weekly SBMs During Weeks 1-8|The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.|Baseline and weeks 1-8|||number of times||Standard Error|Mean
22519|NCT01726504|Secondary|Changes in Mean Weekly CSBMs During Weeks 9–20|The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.|Baseline and weeks 9-20|||number of times||Standard Error|Mean
22520|NCT01726504|Secondary|the Percentage of Participants With Three or More Weekly CSBMs|the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20|1-20 weeks|||percentage of participants|||Number
22521|NCT01726504|Primary|the Change in Mean Weekly CSBMs During Weeks 1–8 Since Treatment|the change number in mean weekly CSBMs during weeks 1–8 since treatment compared with baseline.|Baseline and weeks 1-8|||number of times||Standard Error|Mean
24091|NCT01700348|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assess the safety of the Sonicare AirFloss + MTB treatment.|4 Months||||||
22522|NCT01726335|Secondary|Global Assessment of Functioning (GAF) Scale Score|The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22523|NCT01726335|Secondary|Personal and Social Performance (PSP) Scale Score|The PSP scale assesses the degree of a participant’s dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22524|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22525|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 38|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22526|NCT01726335|Secondary|Short Form-36 (SF-36) - Quality of Life|The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Deviation|Mean
22527|NCT01726335|Secondary|Drug Attitude Inventory (DAI-10)|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Screening, and Week 8, 24 and 50|ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Error|Mean
22528|NCT01726335|Secondary|Extrapyramidal Symptoms Rating Scale (ESRS) Total Score|The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).|Baseline and Week 2, 4, 8, 16, 24 and 50|Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Error|Mean
22529|NCT01726335|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 2, 4, 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22530|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 24|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22531|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 16|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
44907|NCT01388816|Secondary|Changes in Vital Signs Including Blood Pressure|Vital sign abnormalities reported as treatment-emergent AEs|28 days|ITT/Safety Population||participants|||Number
22532|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 8|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22533|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 4|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22534|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 2|Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.||Units on a scale||Standard Error|Mean
22535|NCT01726049|Other Pre-specified|Echocardiographic Parameters of Diastolic LV Dysfunction||12 weeks||||||
22536|NCT01726049|Secondary|Wedge Pressure Measured Invasively by Right Heart Catheterization|Difference in change of wedge pressure between baseline and 12 weeks between Sildenafil group and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in wedge pressure could be evaluated in the ITT analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group||mmHg||95% Confidence Interval|Mean
22537|NCT01726049|Secondary|Cardiac Output Measured Invasively by Right Heart Catheterization|difference in change of cardiac output between baseline and 12 weeks between Sildenafil and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in cardiac output could be evaluated in the ITT analyses in 20 and 22 subjects of the Sildenafil and placebo treatment group||mililiter/min||95% Confidence Interval|Mean
22538|NCT01726049|Secondary|VO2max|difference in change of VO2 max between baseline and 12 weeks between Sildenafil and placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in VO2max could be evaluated in the ITT analyses in 18 and 22 subjects of the Sildenafil and placebo treatment group||ml/kg/min||95% Confidence Interval|Mean
22539|NCT01726049|Primary|Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization|change of mean pulmonary artery pressure between baseline and 12 weeks measured by heart catheterisation|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in mean pulmonary artery pressure could be evaluated in the intention to treat (ITT) analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group||mmHG||95% Confidence Interval|Mean
22540|NCT01726023|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.|PK analysis set||ng/mL||Full Range|Geometric Mean
22541|NCT01726023|Secondary|Safety and Tolerability:ECG , QTcB and QTcF Intervals|Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.|EOT visit/any observation on treatment|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
22542|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.|Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
22543|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Hematology.|Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
22544|NCT01726023|Secondary|Safety and Tolerability by Incidence: Extent of Exposure.|Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
22545|NCT01726023|Secondary|Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.|Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP||Number of patients|||Number
22546|NCT01726023|Secondary|The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|microbiological modified intent-to-treat (mMITT) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.||Days||Full Range|Median
22826|NCT01721096|Secondary|Success Rate: Procedural Success by Lesion||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|Participants|95% Confidence Interval|Number
22547|NCT01726023|Secondary|The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|Clinically evaluable (CE) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.||Days||Full Range|Median
22548|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
22549|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
22550|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
22551|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Participants with favorable responses|||Number
22552|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Participants with favorable responses|||Number
22553|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Participants with favorable responses|||Number
24092|NCT01700348|Secondary|Plaque|Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.|4 Weeks||||||
22554|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Participants with favorable responses|||Number
22555|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Participants with favorable responses|||Number
22556|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Participants with favorable responses|||Number
22557|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants with favorable responses|||Number
22558|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants with favorable responses|||Number
22559|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants with favorable responses|||Number
22560|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
22561|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
22583|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
22584|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
22562|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
22563|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
22564|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
22565|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
22566|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
22567|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
22568|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
22569|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At late follow up (LFU) visits (Day 42 to 49)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Number of patients|||Number
22570|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Number of patients|||Number
22571|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
22585|NCT01725984|Primary|Number of Adverse Events Reported Between Arms|Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events|Prospective follow-up to 36 Months Post Procedure|||Adverse Events|||Number
22827|NCT01721096|Secondary|Success Rate: Implant Success Rate by Device||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|Participants|95% Confidence Interval|Number
22572|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
22573|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Number of patients|||Number
22574|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
22575|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
22576|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.||Number of patients|||Number
22577|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
22578|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
22579|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.||Number of patients|||Number
22580|NCT01726023|Primary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure visit (Day 28 to35)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Number of patients|||Number
22581|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
22582|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|3 Months Post Procedure|||percentage of subjects|||Number
22586|NCT01725984|Primary|Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.|"The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.~The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.~The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7."|Baseline to Prospective Follow Up (up to 36 months)|||Score on a scale||Standard Deviation|Mean
22587|NCT01725984|Primary|Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit|Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.|Prospective follow-up to 36 Months Post Procedure|||percentage of subjects|||Number
22588|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Baseline|||percentage of subjects|||Number
22589|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|3 months Post Procedure|||percentage of subjects|||Number
22590|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|3 Months Post Procedure|||percentage of participants|||Number
22591|NCT01725529|Secondary|Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level|Percentage of participants with on-treatment normalization of alanine aminotransferase level were assessed.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
22592|NCT01725529|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual end of treatment and last HCV RNA measurement during follow-up ≥25 IU/mL.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
22593|NCT01725529|Secondary|Percentage of Participants With Viral Breakthrough|The number of patients who experience viral breakthrough will be determined by measuring Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in plasma. Viral breakthrough was defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in subjects whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment.|Week 24 or 48 (End of Treatment)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
22594|NCT01725529|Secondary|Percentage of Participants With On-treatment Failure|A participant with on-treatment failure refers to a participant with confirmed detectable HCV RNA at the end of treatment.|End of Treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.||percentage of participants|||Number
22595|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72)||Week 72|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.||percentage of participants|||Number
22596|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24)|Participants considered to have achieved SVR24 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ;25 IU/mL) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 24 weeks after the planned end of study drug treatment.|24 weeks after the end of treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.||percentage of participants|||Number
22597|NCT01725529|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment.|12 weeks after the end of treatment (EOT: Week 24 or 48)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.||Percentage of participants|||Number
22598|NCT01725451|Primary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone|The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.||nanograms per deciliter (ng/dL)||Geometric Coefficient of Variation|Geometric Mean
22857|NCT01718691|Secondary|Overall Survival (OS)|Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood’s formula.|Up to 30 weeks|||days||95% Confidence Interval|Median
22599|NCT01725451|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone|The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.||nanograms* hours per deciliter (ng*h/dL)||Geometric Coefficient of Variation|Geometric Mean
22600|NCT01725386|Secondary|Percentage of Participants With Adverse Events||Up to approximately 4 years|Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).||percentage of participants|||Number
22601|NCT01725386|Secondary|Mean Survival Time||Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||Months||95% Confidence Interval|Mean
22602|NCT01725386|Secondary|Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
22603|NCT01725386|Secondary|Percentage of Participants With Relevant Medical History Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
22604|NCT01725386|Primary|Percentage of Participants Receiving Concomitant Medications During the Study|Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
22605|NCT01725386|Primary|Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy|To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).||percentage of participants|||Number
22606|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).|Weeks 4, 8|SAF; LOCF imputation method was used for all time points. N is the number of participants with available data. Only participants who had a response were included in the analysis.||participants|||Number
22607|NCT01725308|Secondary|Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.|Weeks 4, 8|SAF; LOCF imputation method was used for all time points. N is the number of participants with available data. Only participants who had a response were included in the analysis.||participants|||Number
22608|NCT01725308|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS)|"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates “Absent” or “Normal."|Baseline and Weeks 1, 2, 3 4, 6, 8|SAF; LOCF imputation method for end of Treatment period I was used. N is the number of participants with available data at the time point.||units on a scale||Standard Deviation|Mean
22609|NCT01725308|Secondary|Change From Baseline in DIEPSS: Parkinsonism|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 to 20."|Baseline and Weeks 4, 8|SAF; LOCF imputation method for end of Treatment period I was used. N is the number of participants with available data at the time point.||units on a scale||Standard Deviation|Mean
22610|NCT01725308|Secondary|Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 to 32, and excludes the global assessment of severity."|Baseline and Weeks 4, 8|SAF; LOCF imputation method for end of Treatment period I was used. N is the number of participants with available data at the time point.||units on a scale||Standard Deviation|Mean
22636|NCT01724528|Secondary|Assessment of Laboratory Tumor Lysis Syndrome (LTLS)|Assessment of LTLS, from Day 3 to Day 8. According to Cairo-Bishop definition LTLS is defined by the presence of 2 or more laboratory abnormalities including: a 25% increase or levels above normal for serum uric acid, potassium, and phosphate or a 25% decrease or levels below normal for calcium.|6 days|ITT; no imputation applied||% of patients with LTLS occurrence|||Number
22611|NCT01725308|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.|up to 8 weeks|Safety Analysis Set (SAF), which included participants who received at least one dose of study drug.||participants|||Number
22612|NCT01725308|Secondary|CGI-BP-C: Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
22613|NCT01725308|Secondary|CGI-BP-C: Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
22614|NCT01725308|Secondary|Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
22615|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
22616|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
22617|NCT01725308|Secondary|Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
22618|NCT01725308|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.||units on a scale||Standard Deviation|Mean
22619|NCT01725308|Secondary|Change From Baseline in MADRS Total Score|The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
22620|NCT01725308|Primary|Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Week 8|FAS. Last observation carried forward (LOCF) imputation for end of Treatment Period I was used.||units on a scale||Standard Deviation|Mean
22621|NCT01725282|Secondary|Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests|An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|Up to 8 weeks|||participants|||Number
22622|NCT01725282|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality.|Baseline and Week 6|Full analysis set with available PSQI data; LOCF was used.||units on a scale||Standard Deviation|Mean
22637|NCT01724528|Secondary|Treatment Responder Rate|Assessment of treatment responder rate, where treatment response is defined as the maintenance of sUA ≤ 7.5 mg/dL from Day 3 to Day 8|6 days|Intention to Treat (ITT; no imputation applied||% of patients who fail to respond|||Number
22819|NCT01721096|Secondary|Composite Endpoint of Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
22623|NCT01725282|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)|"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are:~Limitation in physical activities because of health problems.~Limitations in usual role activities because of physical health problems.~Bodily pain.~Limitations in social activities because of physical or emotional problems.~General mental health (psychological distress and well-being).~Limitations in usual role activities because of emotional problems.~Vitality (energy and fatigue).~General health perception.~Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status."|Baseline and Week 6|Full analysis set with available SF-36 data; LOCF was used.||units on a scale||Standard Deviation|Mean
22624|NCT01725282|Secondary|Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)|"The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened.~Improvement is defined as a score of 1 or 2."|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
22625|NCT01725282|Secondary|Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)|The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state.|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
22626|NCT01725282|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 6|Full Analysis Set: Participants who met the following requirements: major depressive disorder confirmed at registration; at least one dose of the study drug for the treatment period was administered; and at least one efficacy variable was assessed after the start of treatment. Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
22627|NCT01725217|Secondary|Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination|Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group|AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29|Analysis was done on safety dataset||percentage of subjects|||Number
22628|NCT01725217|Secondary|Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group|Within days 1 through 7 postvaccination|Analysis was done on safety dataset||Percentage of Subjects|||Number
22629|NCT01725217|Secondary|Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination|Within days 1 through 7 postvaccination|Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data||Percentage of subjects|||Number
22630|NCT01725217|Secondary|Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset||Percentage of Subjects||95% Confidence Interval|Number
22631|NCT01725217|Secondary|Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset||human serum bactericidal assay titer||95% Confidence Interval|Geometric Mean
22632|NCT01725217|Secondary|Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group|Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM|Day 29|Analysis was done on FAS dataset||Percentage of subjects||95% Confidence Interval|Number
22633|NCT01725217|Primary|Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).~The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA <1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4"|Day 29|Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29||Percentage of subjects||95% Confidence Interval|Number
22634|NCT01724528|Other Pre-specified|Treatment Emergent Signs or Symptoms (TESS)|Incidence, severity, seriousness and treatment-causality of TESS|14 ± 2 days||||||
22635|NCT01724528|Secondary|Assessment of Clinical Tumor Lysis Syndrome (CTLS)|Assessment of CTLS, from Day 3 to Day 8. According to Cairo-Bishop definition, CTLS is defined by the presence of LTLS in addition to 1 or more of the following significant clinical complications: renal insufficiency, cardiac arrhythmias, sudden death and seizures. The grade of CTLS is defined by the maximal grade of the clinical manifestation|6 days|ITT; no imputation applied||% of patients with CTLS occurrence|||Number
22638|NCT01724528|Primary|Preservation of Renal Function|Change in serum creatinine level from baseline (Day 1) to the evaluation visit (Day 8)|8 days|ITT. Sample size calculation: no change in mean serum creatinine level from baseline to the end of treatment for febuxostat group while allopurinol has a increase of 13%; 340 patients were sufficient to achieve approximately 80% power. Imputation method: LOCF; missing baseline values were not replaced||change %||Standard Deviation|Mean
22639|NCT01724528|Primary|Serum Uric Acid (sUA) Level Control|Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)|8 days|Intention to treat (ITT), defined as all randomized patients. Sample size calculation: at least an absolute reduction of 100 mg x h/dL for the AUCsUA1-8 in favour of febuxostat; 340 patients were sufficient to achieve approximately 80% power. Imputation method: last observation carried forward (LOCF); missing baseline values were not replaced.||mg x hour/dL||Standard Deviation|Mean
22640|NCT01724359|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22641|NCT01724359|Secondary|Sleep Evaluation Scale|This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22642|NCT01724359|Secondary|Health Status as Measured by Self-rated Health Status Survey SF-36|The SF-36 is designed to examine a person’s perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 – 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22643|NCT01724359|Secondary|Personal and Social Performance (PSP) Scale|This PSP assesses the degree of a patient’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22644|NCT01724359|Secondary|Clinical Global Impression-Severity (CGIS)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients. Higher scores indicate worsening."|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||participants|||Number
22645|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22646|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22647|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22648|NCT01724359|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
22649|NCT01724216|Primary|Number of Head Images Successfully Collected|Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.|6-months|||Images|Participants||Number
22679|NCT01723397|Primary|Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent|Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.|Day 2 after one week pretreatment with Nasaleze or placebo.|The analysis population includes the 12 participants who completed the study.||units on a scale||Full Range|Median
22650|NCT01724177|Secondary|Number of Participants With Adverse Events|Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Up to data cutoff of 20 November 2014; maximum time on study treatment was 79.7 weeks|Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.||participants|||Number
22651|NCT01724177|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.|Up to the data cut-off date of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.||weeks||95% Confidence Interval|Median
22652|NCT01724177|Secondary|Percentage of Participants Who Had a Achieved a CR, CRu, PR or Stable Disease (SD) as Assessed by the ESEC|The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best responses.|Up to the data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||percentage of participants||95% Confidence Interval|Number
22653|NCT01724177|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) for Responders|The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.|Up to data cut-off of 20 Nov 2014; maximum time on study treatment was 79.7 weeks|The duration of response population consisted of participants who had an objective response.||weeks||95% Confidence Interval|Number
22654|NCT01724177|Secondary|Kaplan-Meier Estimate of Time to Progression (TTP)|Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC|Up to data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||weeks||95% Confidence Interval|Median
22655|NCT01724177|Secondary|Kaplan Meier Estimate of Progression Free Survival (PFS) Assessed by ESEC|PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.|Up to the cut-off date of 20 November 2014; maximum time on study treatment was 79.7 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||weeks||95% Confidence Interval|Median
22656|NCT01724177|Primary|Overall Response Rate (ORR) Based on the Adult T-cell Leukemia-lymphoma (ATLL) Response Criteria and Assessed by the Efficacy-Safety Evaluation Committee (ESEC)|ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is “negative” and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared|Up to the data cut-off of 20 November 2014; maximum time on study treatment was 79.7 weeks|The Efficacy evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide||percentage of participants||95% Confidence Interval|Number
22657|NCT01724021|Secondary|Summary of Observed Serum Rituximab Concentration||pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab. Here, n specifies the number of participants who were evaluable at specified time points.||microgram per milliter||Standard Deviation|Mean
22658|NCT01724021|Secondary|Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time||pre-dose Cycle 2 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab. Here, n specifies the number of participants who were evaluable at specified time points.||percentage of participants|||Number
22659|NCT01724021|Secondary|Percentage of Participants With Anti-Rituximab Antibodies Over Time||pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab. Here, n specifies the number of participants who were evaluable at specified time points.||percentage of participants|||Number
22660|NCT01724021|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
24093|NCT01700348|Secondary|Number of Bleeding Sites|Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks||||||
22661|NCT01724021|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
22662|NCT01724021|Secondary|Disease-free Survival (DFS)|DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
22663|NCT01724021|Secondary|Event-free Survival (EFS)|EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (approximately 25 months)|ITT population included all participants who were randomized in the study.||months||95% Confidence Interval|Median
22664|NCT01724021|Secondary|Complete Response (CR) Rate|CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.|28 days (± 3 days) after Day 1 of the last dose of induction treatment|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.||percentage of participants||95% Confidence Interval|Number
22665|NCT01724021|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Score|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During cycle 4, 8 of treatment (up to 32 weeks)|ITT population included all participants who were randomized in the study. Here, n specifies the number of participants who were evaluable at specified time points.||units on a scale||Standard Deviation|Mean
22666|NCT01724021|Secondary|Cancer Therapy Satisfaction Questionnaire (CTSQ) Score|CTSQ is a validated 16-item questionnaire that measures three domains related to participants’ satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During cycle 4, 8 of treatment (up to 32 weeks)|ITT population included all participants who were randomized in the study. Here, n specifies the number of participants who were evaluable at specified time points.||units on a scale||Standard Deviation|Mean
22667|NCT01724021|Secondary|Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])|Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion|Cycle 2-4, cycle 5-8 for both SC and IV (up to 32 weeks)|ITT population included all participants who were randomized in the study.||minutes||Full Range|Median
22668|NCT01724021|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization of first participant to clinical cutoff (approximately 25 months)|The safety population included all participants who received at least one dose of rituximab.||participants|||Number
22669|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 8.|Cycle 8 (up to 32 weeks)|ITT population included all participants who were randomized in the study.||percentage of participants||95% Confidence Interval|Number
22670|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.|Cycle 6 (up to 24 weeks)|ITT population included all participants who were randomized in the study.||percentage of participants||95% Confidence Interval|Number
22671|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score|"The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.~A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
22672|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in Parkinson’s Disease Sleep Scale 2 (PDSS-2) Total Score|"The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.~A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
22673|NCT01723904|Secondary|Change From Baseline to the End of the Treatment Period in Time Spent “on” Without Troublesome Dyskinesia|"Absolute time spent on without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent on without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||hours/day||Standard Deviation|Mean
22674|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in Absolute Time Spent “Off”|"Absolute time spent off is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent off decreased from Baseline and therefore indicates an improvement from Baseline.~Only subjects with time spent off at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|"Subjects with time spent off at Baseline in the FAS with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64."||hours/day||Standard Deviation|Mean
22675|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Average of “on” and “Off” State) Total Score|"UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).~UPDRS Part II total score (average of on and off state) is the average of UPDRS Part II total score (“on” state) and Part II total score (“off” state).~A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
22676|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (“on” State) Total Score|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.~A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.||units on a scale||Standard Deviation|Mean
22677|NCT01723904|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable~= No side effects~= Side effects do not significantly interfere with subject's functioning~= Side effects significantly interfere with the subject's functioning~= Side effects outweigh therapeutic efficacy."|Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|From the 90 subjects in the Safatey Set, 89 are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.||participants|||Number
22678|NCT01723722|Primary|Length of Treatment With Opioid Medication|Up to 12 months|Up to 12 months|Completion of treatment||days||Standard Deviation|Mean
22687|NCT01723228|Secondary|Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24|The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'|Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline ADCS MCI-CGIC assessment. n=number of participants with the given assessment.||participants|||Number
22680|NCT01723254|Secondary|Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336|Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.|Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)|All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.||units/milliliter (u/mL)||80% Confidence Interval|Number
22681|NCT01723254|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.|Baseline up to 336 days post last study drug administration or Early Termination|All randomized participants who received at least one dose of study treatment.||participants|||Number
22682|NCT01723254|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.|Baseline up to 336 days post study administration or at Early Termination|All randomized participants who received at least one dose of study treatment.||participants|||Number
22683|NCT01723254|Primary|Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination|Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: >2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [>=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).|Within 14 days|All randomized participants who received at least one dose of study treatment.||Percentage of participants||80% Confidence Interval|Number
22684|NCT01723254|Primary|Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination|Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [>] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: >10 cm or 21 caliper units and above).|Within 14 days|All randomized participants who received at least one dose of study treatment.||Percentage of participants||80% Confidence Interval|Number
22685|NCT01723228|Secondary|Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score|UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS ADL Subscale (Part 2) assessment.||units on a scale||Standard Error|Least Squares Mean
22686|NCT01723228|Secondary|Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score|UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS Motor Subscale (Part 3) assessment.||units on a scale||Standard Error|Least Squares Mean
22688|NCT01723228|Secondary|Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score|The PDAQ is a 15-item questionnaire that assesses the patient’s difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline PDAQ assessment.||units on a scale||Standard Error|Least Squares Mean
22689|NCT01723228|Secondary|Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score|The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline MoCA assessment.||units on a scale||Standard Error|Least Squares Mean
22690|NCT01723228|Primary|Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score|The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline SCOPA-COG assessment.||units on a scale||Standard Error|Least Squares Mean
22691|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
22692|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
22693|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
22694|NCT01722994|Secondary|Length of Time Till Absorbable Suture Fall Out|The time post placement when the suture fell out.|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||Days||Standard Deviation|Mean
22695|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.||participants|||Number
22696|NCT01722734|Primary|Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment|Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.|70 hours|The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.||percentage of participants||95% Confidence Interval|Number
22697|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia|In randomized subjects with baseline platelet ≤ 100 x 10^9/L, the proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects With Baseline Thrombocytopenia||Percentage of Participants|||Number
22698|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement|The proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Percentage of Participants|||Number
22699|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia|In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects with Baseline Anemia||Percentage of Participants|||Number
22700|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement|The proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Percentage of Participants|||Number
22701|NCT01722487|Secondary|ORR (Overall Response Rate)|ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||percentage of participants|||Number
23795|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set||rescue medication free days||90% Confidence Interval|Least Squares Mean
22702|NCT01722487|Secondary|Overall Survival (OS)|OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Months||95% Confidence Interval|Median
22703|NCT01722487|Primary|PFS (Progression Free Survival)|"The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS~Progressive disease according to 2008 IWCLL guidelines was defined as:~Group A~Lymphadenopathy, increase ≥50%~Hepatomegaly, increase ≥50%~Splenomegaly, increase ≥50%~Blood lymphocytes, increase ≥ 50% over baseline~Group B~Platelets counts, decrease of ≥ 50% from baseline secondary to CLL~Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL"|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat||Months||95% Confidence Interval|Median
22704|NCT01722435|Secondary|Mean Time Staying in OST|Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).|18 months|||days||Standard Deviation|Mean
22705|NCT01722435|Secondary|Mean Time to Drop-out of OST|Mean time of study participation (M, SD) until drop-out of treatment.|18 months|||days||Standard Deviation|Mean
22706|NCT01722435|Secondary|Mean Time to Complete OST|Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).|18 months|||days||Standard Deviation|Mean
22707|NCT01722435|Primary|OST Drop-outs|Participants dropped out of OST Treatment during the study period.|18 months|||participants|||Number
22708|NCT01722435|Primary|Completion of OST|Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.|18 months|||participants|||Number
22709|NCT01722266|Secondary|Insulin, C-peptide, Glucagon, GLP-1(Glucagon Like Peptide-1) and GIP(Gastric Inhibitory Polypeptide) Concentrations Following Meal Challenge.||12 weeks||||||
22710|NCT01722266|Secondary|Carbohydrate Intake||12 weeks|||grams||Standard Error|Mean
22711|NCT01722266|Secondary|Serum Acetaminophen Concentrations Following Meal Challenge||12 weeks||||||
22712|NCT01722266|Secondary|Reduction in the Area Under Curve(AUC) of Glucose Following the Meal||12 weeks||||||
22713|NCT01722266|Secondary|Percent Time Spent in Hyperglycemia and Hypoglycemia||12 weeks||||||
22714|NCT01722266|Secondary|Change in Total Insulin Dose From Baseline at 12 Weeks|Total insulin dose = Basal insulin dose plus bolus insulin dose.|Baseline and 12 weeks|||Units||Standard Error|Mean
22715|NCT01722266|Secondary|Change in Body Weight From Baseline at Week 12||Baseline and 12 weeks|||Kg||Standard Error|Mean
22716|NCT01722266|Secondary|Change in HbA1c From Baseline at 12 Weeks||Baseline and 12 Weeks|||Percent||Standard Error|Mean
22717|NCT01722266|Primary|Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks|The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.|12 Weeks|||mg/dl||Standard Error|Mean
22718|NCT01722162|Primary|Progression Free Survival (Arm B)|Time from start of treatment to the time of progression or death, whichever occurs first.|Until progressive disease (PD) (up to 60 days)|||proportion of patients with PFS||95% Confidence Interval|Number
22719|NCT01722162|Secondary|Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events|NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 6 months|||participants|||Number
22720|NCT01722162|Primary|Progression Free Survival (Arm A)|Time from start of treatment to the time of progression or death, whichever occurs first.|Until progressive disease (PD) (estimated to be 92 days)|||proportion of patients with PFS||95% Confidence Interval|Number
22721|NCT01722097|Other Pre-specified|Patient-movements|Number of unintended and unwanted patient-movements registered by the surgeon|During surgery||||||
22722|NCT01722097|Secondary|Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)|"Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.~Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.~Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery."|within 14 days|||units on a scale*days||Inter-Quartile Range|Median
22723|NCT01722097|Primary|Shoulder Pain|"Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation.~VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100)."|within 14 days|||participants|||Number
22724|NCT01722071|Primary|Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.|"Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.~Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.~Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates)."|Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).|Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.||BOLD signal change (beta values)||Standard Error|Mean
22725|NCT01721967|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established|60 days post treatement|||units on a scale||Standard Deviation|Mean
22820|NCT01721096|Secondary|Composite Endpoint of Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
22726|NCT01721967|Secondary|Seattle Angina Questionnaire (SAQ)|The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.|60 Days post treatment|||units on a scale||Standard Deviation|Mean
22727|NCT01721967|Secondary|Improvement in Number of Episodes of Angina Per Week|Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).|Baseline and 60 Days post treatment|episodes of angina per week was not collected|||||
22728|NCT01721967|Primary|Safety of Ranolazine With Regard to Drug Tolerability|Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose|60 days|||participants|||Number
22729|NCT01721967|Primary|Safety of Ranolazine With Regard to Adverse Events|Number of events that are considered probably or possibly related to study drug.|60 Days|||adverse event|||Number
22730|NCT01721967|Primary|Safety of Ranolazine With Regard to QT Interval||60 Days|||msec||Standard Deviation|Median
22731|NCT01721837|Primary|Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)|The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.|One single observation time point: at the time of prescription before the first intake of dabigatran etexilate|All patients with documented mild or moderate renal impairment and non-valvular atrial fibrillation (PPS) having evaluable data for age, gender, body weight, and serum creatinine. In 145 patients age, gender, serum creatinine or weight was missing so that Creatinine Clearance according to the Cockcroft Gault formula could not be recalculated.||ml/min||Inter-Quartile Range|Median
22732|NCT01721772|Secondary|Change From Baseline in Health-related Quality of Life (HRQoL) Scores|HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.|At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 17 months|All participants randomized to receive treatment; n=number of participants evaluable||Units on a scale||Standard Deviation|Mean
22733|NCT01721772|Primary|Overall Survival (OS) Rate|OS rate is calculated as the percentage of participants who have not died divided by the total number of participants in the arm, based on Kaplan-Meier estimates|Randomization to 6 months and 12 months|All participants randomized to receive treatment||Percentage of participants||95% Confidence Interval|Number
22734|NCT01721772|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, and Drug-related AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|Day of first dose to day of final dose + 30 days, assessed up go 17 months|All participants who received at least 1 dose of study drug||Participants|||Number
22735|NCT01721772|Secondary|Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level|Overall Survival by PD-L1 expression level, which was defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% versus patients with tumor PD-L1 expression <5%. Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.|From date of randomization to date of disease progression or death, as assessed to 17 months|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
22736|NCT01721772|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with a best overall response of RECIST-defined complete response (CR) or partial response (PR) divided by the number of randomized participants in each treatment arm. RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment||Percentage of participants||95% Confidence Interval|Number
22737|NCT01721772|Secondary|Progression-free Survival (PFS) Rate|The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment||Percentage of participants||95% Confidence Interval|Number
22749|NCT01721317|Secondary|Change From Baseline in Urine Potential of Hydrogen (pH)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize ot evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22821|NCT01721096|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)||1 year post index procedure|||percentage of participants|||Number
22738|NCT01721772|Secondary|Progression-free Survival (PFS)|"Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death.~Those who did not progress or die were censored on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were censored on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy."|From date of randomization to date of disease progression or death, assessed to 17 months|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
22739|NCT01721772|Primary|Overall Survival (OS)|OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.|From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed to 17 months.|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
22740|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.~Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
22741|NCT01721759|Secondary|Objective Response Rate (ORR) as Assessed by Investigator|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment.~Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using RECIST v1.1, to confirm response."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
22742|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.~Participants were evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 19 months|Participants who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
22743|NCT01721564|Secondary|Intravascular Ultrasound - Pulmonary Artery Wall Thickness|Change in intima-media thickness|baseline and 6 months|||percentage of baseline||Standard Deviation|Mean
22744|NCT01721564|Primary|Acetylcholine Vascular Reactivity Response|Percent pulmonary flow change from baseline after acetylcholine|Baseline and 6 months|||percentage of baseline||Standard Deviation|Mean
22745|NCT01721330|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.|6 weeks|One subject withdrew from the study before receiving study medication, so data from only two subjects was analyzed (one subject in each group). Therefore, means and standard deviations were not calculated.||units on a scale|||Number
22746|NCT01721317|Secondary|Number of Participants With the Indicated Assessment Events of Suicidal Behavior, Suicidal Ideation or Non-suicidal Self Injurious Behavior Via the Columbia Suicide Severity Rating Scale (C-SSRS)|Prospective assessment of suicidality was conducted using the Columbia-Suicide Severity Rating Scale (C-SSRS), a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. C-SSRS data were only collected through Week 8 for the 6 randomized participants. Due to the study being prematurely terminated, there was not sufficient data to evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 4, Week 6 and Week 8|Safety Population||Participants|||Number
22747|NCT01721317|Secondary|Change From Baseline in Post-void Residual (PVR) Urinary Bladder Ultrasound Volume|The change from Baseline in the PVR bladder ultrasound results was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase) and Week 18 (end of Maintenance Phase)|Safety Population|||||
22748|NCT01721317|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|The change from Baseline in the following urinalysis parameters (urine occult blood, urine glucose, urine ketones and urine protein) were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22813|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or MI||1 year post index procedure|||percentage of participants|||Number
22750|NCT01721317|Secondary|Change From Baseline in Urine Specific Gravity (USG)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22751|NCT01721317|Secondary|Change From Baseline in Creatinine Clearance|The change from Baseline in the indicated chemistry test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22752|NCT01721317|Secondary|Change From Baseline in BUN/Creatinine Ratio|The change from Baseline in the indicated chemistry tests was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22753|NCT01721317|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, Glucose, Magnesium, Phosphorus Inorganic, Bicarbonate and Urea/Blood Urea Nitrogen (BUN)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22754|NCT01721317|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid and Creatinine|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22755|NCT01721317|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyltransferase (GGT)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22756|NCT01721317|Secondary|Change From Baseline in Albumin and Total Protein|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22757|NCT01721317|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22758|NCT01721317|Secondary|Change From Baseline in Red Blood Cell (RBC) Count|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22759|NCT01721317|Secondary|Change From Baseline in Hematocrit|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22760|NCT01721317|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22761|NCT01721317|Secondary|Change From Baseline in the Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils, White Blood Cell (WBC) Count and Platelet Count|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22762|NCT01721317|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils and Red Blood Cell (RBC) Distribution Width|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22763|NCT01721317|Secondary|Change From Baseline in the QT Interval Using Bazett’s Correction (QTcB) and QT Interval Using Fridericia’s Correction (QTcF)|Change from Baseline in the QT interval using Bazett's correction (QTcB) and QT interval using Fridericia's correction were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22764|NCT01721317|Secondary|Change From Baseline in Heart Rate|Change from Baseline in heart rate was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22765|NCT01721317|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from Baseline in blood pressure was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22766|NCT01721317|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population|||||
22767|NCT01721317|Secondary|Number of Participants With Early Study Discontinuation|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of participants with early study discontinuation.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population||Participants|||Number
22768|NCT01721317|Secondary|Number of Participants at Each Dose During the Maintenance Phase and Average Maintenance Dose Over All Participants|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the number of participants at each dose during the Maintenance Phase and the average maintenance dose over all participants. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 11 (start of Maintenance Phase) to Week 18 (end of Maintenance Phase)|Safety Population|||||
22769|NCT01721317|Secondary|Incidence of New Seizure Types in Participants Without a History of These Seizure Types|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of new seizure types in participants without a history of these seizure types. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population: all randomized participants who receive >= 1 dose of study medication.|||||
22770|NCT01721317|Secondary|Percent Change From Baseline in Functional Status (Epilepsy-related Worry and Activity Limitation) and Productivity (Missed Work or School) to the End of the Dose-Optimization Phase and the End of the Maintenance Phase|The effect of ezogabine/retigabine IR as an adjunctive treatment on health outcomes was to be evaluated on the basis of functional status and productivity. Participants were asked to complete the paper functional status diary to collect information to assess how the participant’s functional status is affected by their epilepsy symptoms. Participants were asked to rate their epilepsy-related worry, activity limitations, and productivity (missed work or school). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
22771|NCT01721317|Secondary|Change From Baseline in the Number of Seizure Free Days for the Indicated Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and the Dose-Optimization + Maintenance Phase|The change in number of seizure free days during the Double-Blind period, the Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
22772|NCT01721317|Secondary|Number of Seizure Free Participants for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|Participants without seizures during the interval of Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose-Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
22773|NCT01721317|Secondary|Number of Par. Experiencing >=50% Reduction in 28-day Total Partial Seizure Frequency (POS) for the Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and Dose-Optimization + Maintenance Phase|Participants (par.) experiencing >= 50% reduction from Baseline to the end of the Double-Blind Phase in 28-day total POS were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population|||||
22774|NCT01721317|Secondary|Percent Change in 28-day Total Partial Seizure Frequency (POS) for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in total partial seizure frequency during the Dose-Optimization Phase and Maintenance Phase. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population|||||
22775|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) Within Each Stratum From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The percent change in 28-day total POS frequency within each stratum (sodium channel blocker or non-sodium channel blocker) background antiepileptic drug (AED) was to be summarized as the supportive analysis. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population|||||
22814|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or MI||8 months post index procedure|||percentage of participants|||Number
22815|NCT01721096|Secondary|Composite Endpoint of Death or MI||1 year post index procedure|||percentage of participants|||Number
22816|NCT01721096|Secondary|Composite Endpoint of Death or MI||8 months post index procedure|||percentage of participants|||Number
22776|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in the total partial seizure frequency, which was recorded by participants in the daily seizure calendar. The total 28-day POS rate is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and who had >= 1 post-Baseline seizure diary day with >= 0 seizures recorded.|||||
22777|NCT01721226|Secondary|Linkage to Community Care|At least 1 visit to health care provider in past 24 weeks/6 months|24 weeks|||Participants|||Count of Participants
22778|NCT01721226|Primary|Plasma Viral Load Suppression|Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction|24 weeks|All study participants with available PVL data||participants|||Number
22779|NCT01721161|Secondary|Summary of BIIB033 Concentration|One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.|Up to 32 weeks|PK analysis population: all participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data on record. n=number of participants with a sample at given timepoint.||µg/mL||Full Range|Median
22780|NCT01721161|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|32 weeks|Safety population: all participants who received at least 1 dose of study treatment.||participants|||Number
22781|NCT01721161|Primary|Change in FF-VEP Latency at Week 24: Per-protocol Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS)-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||msec||Standard Error|Mean
22782|NCT01721161|Secondary|Change in LCLA at Week 24: Per-protocol Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||letters on a chart||Standard Error|Mean
22783|NCT01721161|Secondary|Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with an LCLA assessment at Baseline. LOCF imputation was used if Week 24 data were missing.||letters on a chart||Standard Deviation|Mean
22784|NCT01721161|Secondary|Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||µm||Standard Deviation|Mean
22785|NCT01721161|Secondary|Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with a valid RGCL/IPL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.||µm||Standard Deviation|Mean
22786|NCT01721161|Secondary|Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.||percentage change||Standard Error|Mean
22822|NCT01721096|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)||8 months post index procedure|||percentage of participants|||Number
22787|NCT01721161|Secondary|Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) and a valid RNFL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.||percentage change||Standard Error|Mean
22788|NCT01721161|Primary|Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo). Last observation carried forward (LOCF) imputation was used if Week 24 data were missing.||msec||Standard Error|Mean
22789|NCT01721096|Secondary|Net Gain: In-stent, In-segment|Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain – late loss).|8 months post index procedure|||mm|Participants|Standard Deviation|Mean
22790|NCT01721096|Secondary|Late Loss(LL): In-stent, In-segment, Proximal, and Distal|Late loss is calculated as MLD post procedure – MLD at follow-up.|8 months post index procedure|||mm|Participants|Standard Deviation|Mean
22791|NCT01721096|Secondary|Acute Gain: In-stent, In-segment|The difference between post- and pre-procedural MLD.|8 months post index procedure|||mm|Participants|Standard Deviation|Mean
22792|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|8 months post index procedure|Number of participants analyzed includes the number available for QCA.||percentage of DS|Participants|Standard Deviation|Mean
22793|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|Post procedure|||percentage of DS|Participants|Standard Deviation|Mean
22794|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Baseline|||percentage of DS|Participants|Standard Deviation|Mean
22795|NCT01721096|Secondary|Bleeding||1 year post index procedure|||percentage of participants|||Number
22796|NCT01721096|Secondary|Bleeding||8 months post index procedure|||percentage of participants|||Number
22797|NCT01721096|Secondary|All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|1 year post index procedure|||percentage of participants|||Number
22798|NCT01721096|Secondary|All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|8 months post index procedure|||percentage of participants|||Number
22799|NCT01721096|Secondary|Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|1 year post index procedure|||percentage of participants|||Number
22800|NCT01721096|Secondary|Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|8 months post index procedure|||percentage of participants|||Number
22801|NCT01721096|Secondary|Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|1 year post index procedure|||percentage of participants|||Number
22802|NCT01721096|Secondary|Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|8 months post index procedure|||percentage of participants|||Number
22803|NCT01721096|Secondary|Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR|1 year post index procedure|||percentage of participants|||Number
22804|NCT01721096|Secondary|Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|8 months post index procedure|||percentage of participants|||Number
22805|NCT01721096|Secondary|Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|1 year post index procedure|||percentage of participants|||Number
22806|NCT01721096|Secondary|Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|8 months post index procedure|||percentage of participants|||Number
22807|NCT01721096|Secondary|Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|1 year post index procedure|||percentage of participants|||Number
22808|NCT01721096|Secondary|Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|8 months post index procedure|||percentage of participants|||Number
22809|NCT01721096|Secondary|Death|Death includes cardiac death, non-cardiac death and non-coronary death.|1 year post index procedure|||percentage of participants|||Number
22810|NCT01721096|Secondary|Death|Death includes cardiac death, non-cardiac death and non-coronary death.|8 months post index procedure|||percentage of participants|||Number
22811|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or Target Vessel MI||1 year post index procedure|||percentage of participants|||Number
22812|NCT01721096|Secondary|Composite Endpoint of Cardiac Death or Target Vessel MI||8 months post index procedure|||percentage of participants|||Number
22828|NCT01721096|Primary|Overall Stent Thrombosis|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
22829|NCT01721096|Primary|Late Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Late (>30 days to 1 year)|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
22830|NCT01721096|Primary|Subacute Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Subacute (>24 hours to 30 days)|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
22831|NCT01721096|Primary|Acute Stent Thrombosis (ST)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Time Frame: Acute (0-24 hours)|The number of participants analyzed excludes subjects who were lost-to-follow-up.||percentage of participants|||Number
22832|NCT01721070|Primary|Cmax|Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||pg/mL||Standard Deviation|Mean
22833|NCT01721070|Primary|AUC (0-inf)|Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
22834|NCT01720797|Primary|Tooth Movement Between the Groups|"Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.~Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement."|6 months|||percentage of movement||Standard Deviation|Mean
22835|NCT01720602|Secondary|Overall Survival|Kaplan-Meier survival curves will be used to describe overall survival.|Up to 5 years||||||
22836|NCT01720602|Secondary|Progression-free Survival (PFS)|Kaplan-Meier survival curves will be used to describe PFS.|Up to 5 years||||||
22837|NCT01720602|Secondary|Duration of Response|Duration of response will be summarized for responders.|Up to 5 years|||weeks||Full Range|Median
22838|NCT01720602|Primary|Response Rate According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the response rate.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks|||percentage of patients||90% Confidence Interval|Number
22839|NCT01720602|Primary|Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks|||percentage of patients||90% Confidence Interval|Number
24094|NCT01700348|Secondary|Gingival Inflammation|Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.|4 weeks||||||
22840|NCT01720251|Other Pre-specified|Immunological Markers: Specific IgE and IgG4|blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4|before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013||||||
22841|NCT01720251|Secondary|Safety and Tolerability|Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject|from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks||||||
22842|NCT01720251|Secondary|Quality of Life|mini-RQLQ questionnaires|up to 6 weeks during the birch pollen season 2013||||||
22843|NCT01720251|Primary|Combined Rhinoconjunctivitis Symptom and Medication Score|"The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.~The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2"|up to 6 weeks during the birch pollen season 2013|||score (maximum=3)||Standard Deviation|Mean
22844|NCT01719757|Secondary|Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject|The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.|4 weeks|Intent to treat analysis set(Last observational carried forward)||participants|||Number
22845|NCT01719757|Secondary|Change of Constipation Assessment From Baseline to Visit 2(End Visit)|Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)|4 weeks|Intent to treat analysis set(Last observational carried forward)||score||Standard Deviation|Mean
22846|NCT01719757|Secondary|Change of Eastern Cooperative Oncology Group(ECOG) Performance Status|"If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse.~ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death."|4weeks|Intent to treat analysis set: 304||Score||Standard Deviation|Mean
22847|NCT01719757|Primary|Change in Numeric Rating Scales (NRS) Score|Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).|4 weeks|Intent to treat analysis set: 304||units on a scale||Standard Deviation|Mean
22848|NCT01719172|Secondary|Median Time to Achieve Hemostasis|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)|||Minutes||95% Confidence Interval|Median
22849|NCT01719172|Secondary|Proportion of Subjects Who Achieve Hemostasis Within 1 Minute|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)|||participants|||Number
22850|NCT01719172|Primary|Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment|Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)|||participants|||Number
22851|NCT01719003|Secondary|Body Weight Change From Baseline at Week 24|"Change from baseline in body weight (kg) after 24 weeks of treatment.~“Baseline” refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)||kg||Standard Error|Mean
22852|NCT01719003|Secondary|FPG (Fasting Plasma Glucose) Change From Baseline at Week 24|"Change from baseline in FPG (mg/dL) after 24 weeks of treatment.~“Baseline” refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)||mg/dL||Standard Error|Mean
22853|NCT01719003|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24|"Change from baseline in HbA1c (%) after 24 weeks of treatment.~“Baseline” refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means"|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)||percentage of HbA1c||Standard Error|Mean
22854|NCT01718691|Secondary|Laboratory Test Abnormalities (Hematology Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks|||participants|||Number
22855|NCT01718691|Secondary|Laboratory Test Abnormalities (Biochemical Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks|||participants|||Number
22856|NCT01718691|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.|up to 30 weeks|||participants|||Number
22858|NCT01718691|Secondary|Duration of Response (DOR)|"DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood’s formula.~The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).~Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause."|Up to 30 weeks|||days||95% Confidence Interval|Median
22859|NCT01718691|Secondary|Progression-Free Survival (PFS)|"PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood’s formula.~Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response)."|Up to 30 weeks|||days||95% Confidence Interval|Median
22860|NCT01718691|Secondary|"Overall Response Rate (PR or Better) Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)"|"The criteria for Overall response rate (PR or better) based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.~Definition of PR:~Measurable disease:~50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.~Unmeasurable disease:~Estimated decrease in tumor size of 50% or more for at least 4 weeks.~Bone metastases:~Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks."|Up to 30 weeks|||percentage of participants|||Number
22861|NCT01718691|Secondary|Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)|"The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.~Measurable disease:~The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.~Unmeasurable disease:~Complete disappearance of all known disease for at least 4 weeks.~Bone metastases:~Complete disappearance of all lesions on X-ray or scan for at least 4 weeks."|Up to 30 weeks|||percentage of participants|||Number
22862|NCT01718691|Secondary|Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for PR based on the Revised RC are shown below.~Definition: Regression of measurable disease and no new sites~Nodal Masses:~50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT~Spleen, Liver:~50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen~Bone Marrow:~Irrelevant if positive prior to therapy; cell type should be specified."|Up to 30 weeks|||percentage of participants|||Number
22863|NCT01718691|Secondary|Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for CR based on the Revised RC are shown below.~Definition: Disappearance of all evidence of disease~Nodal Masses:~[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.~Variably FDG-avid or PET negative; regression to normal size on CT.~Spleen, Liver:~Not palpable, nodules disappeared~Bone Marrow:~Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative."|Up to 30 weeks|||percentage of participants|||Number
22864|NCT01718691|Secondary|Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for PR based on IWRC are shown below.~PR: SPD regressed > 50%"|Up to 30 weeks|||percentage of participants|||Number
22865|NCT01718691|Primary|Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for CR and CRu based on IWRC are shown below.~CR: Fulfills all of the following~Disappearance of all detectable disease~LN* > 1.5 cm must decrease to ≤ 1.5 cm~CRu: Fulfills all of the following~LN >1.5 cm; SPD** decrease >75%~indeterminate bone marrow~LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters"|Up to 30 weeks|||percentage of participants|||Number
22866|NCT01718535|Primary|Percent Agreement|The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.|After second pass result is complete (~3hours)|||Percent Agreement||95% Confidence Interval|Number
22867|NCT01718509|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|Safety Analysis Set||units on a scale||Standard Deviation|Mean
22868|NCT01718509|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 12 weeks|Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. All subjects from Site 015 were excluded from the Safety Analysis Set.||participants|||Number
22869|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
22870|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
22871|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
22872|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
22873|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
22874|NCT01718509|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks|The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from “1” (almost never) to “5” (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.|Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||t-scores||Standard Error|Least Squares Mean
22875|NCT01718509|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and week 12|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
22876|NCT01718509|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.|Baseline and week 12|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
22877|NCT01718509|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12||Baseline and Visit 8 Which Spans Weeks 11/12|Full Analysis Set.||Binge episodes per week||Standard Error|Least Squares Mean
22878|NCT01718509|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows:~1-week Cessation = 100% reduction in binge episodes during the preceding 7 days~Marked Reduction = 99% to 75% reduction during the time since the previous visit~Moderate Reduction = 74% to 50% reduction during the time since the previous visit~Negative to Minimal Reduction = <50% reduction during the time since the previous visit"|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||percentage of participants|||Number
22879|NCT01718509|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||Percent||Standard Error|Least Squares Mean
22880|NCT01718509|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||mmol/L||Standard Error|Least Squares Mean
22881|NCT01718509|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.||mmol/L||Standard Error|Least Squares Mean
22882|NCT01718509|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and week 12|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
22883|NCT01718509|Secondary|Percent Change From Baseline in Body Weight (kg) at Week 12||Baseline and week 12|Full Analysis Set.||percentage change||Standard Error|Least Squares Mean
22884|NCT01718509|Secondary|Percent of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
22885|NCT01718509|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
22886|NCT01718509|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.|Baseline and Visit 8 Which Spans Weeks 11/12|The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).||Binge days per week||Standard Error|Least Squares Mean
22887|NCT01718483|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.||units on a scale||Standard Deviation|Mean
22888|NCT01718483|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Number of participants with suicidal ideation and suicidal behavior were reported.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.||participants|||Number
22889|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
22890|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
22891|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
22892|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
22893|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
22894|NCT01718483|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12|The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from “1” (almost never) to “5” (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||t-scores||Standard Error|Least Squares Mean
22895|NCT01718483|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||units on a scale||Standard Error|Least Squares Mean
22896|NCT01718483|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|"The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake).~Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger."|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||units on a scale||Standard Error|Least Squares Mean
22897|NCT01718483|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)||Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||Binge episodes per week||Standard Error|Least Squares Mean
24136|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
22898|NCT01718483|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows:~1-week Cessation = 100% reduction in binge episodes during the preceding 7 days.~Marked Reduction = 99% to 75% reduction during the time since the previous visit.~Moderate Reduction = 74% to 50% reduction during the time since the previous visit.~Negative to Minimal Reduction = <50% reduction during the time since the previous visit."|Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||percentage of participants|||Number
22899|NCT01718483|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||Percent hemoglobin||Standard Error|Least Squares Mean
22900|NCT01718483|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||mmol/L||Standard Error|Least Squares Mean
22901|NCT01718483|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and Week 12/Early termination (ET)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
22902|NCT01718483|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.||units on a scale||Standard Error|Least Squares Mean
22903|NCT01718483|Secondary|Percent Change From Baseline in Body Weight at Week 12||Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||percent change||Standard Error|Least Squares Mean
22904|NCT01718483|Secondary|Percentage of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||percentage of participants||95% Confidence Interval|Number
22905|NCT01718483|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||percentage of participants||95% Confidence Interval|Number
22906|NCT01718483|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.|Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).||Binge days per week||Standard Error|Least Squares Mean
22907|NCT01718028|Secondary|Percent Change From Baseline in NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||percent change||Standard Deviation|Mean
22908|NCT01718028|Secondary|Mean NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||seconds||Standard Deviation|Mean
22909|NCT01718028|Secondary|Mean Change From Baseline in NITFBUT at Day 14|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||seconds||Standard Deviation|Mean
24137|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
22910|NCT01718028|Primary|Mean Change From Baseline in NITFBUT at Day 30|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit||seconds||Standard Deviation|Mean
22911|NCT01717989|Secondary|Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out||June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||participants|||Number
22912|NCT01717989|Secondary|Number of Participants Taking Epoetin Alfa by Month|The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis at each time point.||participants|||Number
22913|NCT01717989|Secondary|Cumulative Monthly Dose of Epoetin Alfa Administered|The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.||units||Inter-Quartile Range|Median
22914|NCT01717989|Secondary|Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL|The mean percentage of participants per facility with transferrin saturation < 20% and ferritin level < 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.||percentage of participants per facility|Participants|95% Confidence Interval|Mean
22915|NCT01717989|Secondary|Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time|Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin < 10 g/dL: Faciities with 0 to <5% of participants with hemoglobin < 10 g/dL; Facilities with 5 to < 10% of participants with hemoglobin < 10 g/dL; Facilities with 10 to < 15% participants with hemoglobin < 10 g/dL; Facilities with 15 to < 20% of participants with hemoglobin < 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin < 10 g/dL.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities with at least one non-missing hemoglobin record, for participants included in the primary analysis set who were on study and with available data at each time point.||percentage of facilities|Participants||Number
22916|NCT01717989|Secondary|Mean Hemoglobin Concentration by Quarter||Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point and with available data.||g/dL||Standard Deviation|Mean
22917|NCT01717989|Secondary|Percentage of Participants Receiving a Vitamin D Sterol|The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
22918|NCT01717989|Secondary|Percentage of Participants Receiving Phosphate Binding Agents|The percentage of participants receiving phosphate binding agents over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
22919|NCT01717989|Secondary|Percentage of Participants Receiving Cinacalcet|The percentage of participants receiving cinacalcet (Sensipar) over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
22920|NCT01717989|Secondary|Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)|The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set facilities / participants on study at each time point.||percentage of participants per facility|Participants|95% Confidence Interval|Mean
22921|NCT01717989|Secondary|Percentage of Participants in Each Vascular Access Type Category|The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study and on hemodialysis at each time point||percentage of participants|||Number
22922|NCT01717989|Primary|Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%|"The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:~Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility."|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing URR record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).||percentage of participants per facility|Participants|95% Confidence Interval|Mean
22923|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin > 12 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin > 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).||percentage of participants per facility|Participants|95% Confidence Interval|Mean
23803|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set||symptom free days||90% Confidence Interval|Least Squares Mean
22924|NCT01717989|Secondary|Percentage of Participants Treated by Each Dialysis Modality|The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point||percentage of participants|||Number
22925|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin < 10 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin < 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).||percentage of participants per facility|Participants|95% Confidence Interval|Mean
22926|NCT01717872|Secondary|Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis|The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.|30 seconds|||percent of glottic opening||95% Confidence Interval|Mean
22927|NCT01717872|Secondary|Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue|30 seconds|||percent of glottic opening||95% Confidence Interval|Mean
22928|NCT01717872|Primary|The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue|30 seconds|||percentage of Glottic opening||95% Confidence Interval|Mean
22929|NCT01717768|Other Pre-specified|AUC 0-24 Hrs After 120 mg Dose of TSX-002|AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).||hr×ng/dL||Standard Deviation|Median
22930|NCT01717768|Other Pre-specified|Cavg 0-24 Hrs (ng/dL) After 120 mg Dose|PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).||ng/dL||Standard Deviation|Least Squares Mean
22931|NCT01717768|Secondary|Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment|Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.||percentage of subjects|||Number
22932|NCT01717768|Primary|Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002|Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.||percentage of participants|||Number
22933|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.||Number of participants|||Number
22934|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.||Number of subjects|||Number
22935|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.||Number of subjects|||Number
22936|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.|From day 1 to day 7 after any vaccination|Analysis was done on the safety population.||Number of subjects|||Number
22937|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population.||Number of subjects|||Number
22938|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.||Number of subjects|||Number
22939|NCT01717638|Secondary|Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
22940|NCT01717638|Secondary|GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Ratio||95% Confidence Interval|Geometric Mean
22941|NCT01717638|Secondary|GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
22942|NCT01717638|Secondary|Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.|"The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.~Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.~Immune sufficiency was not applicable for M10713 strain."|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
22943|NCT01717638|Secondary|Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine|"The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.~Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer."|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
22944|NCT01717638|Secondary|GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.|The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Ratio||95% Confidence Interval|Geometric Mean
22945|NCT01717638|Secondary|GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
22946|NCT01717638|Secondary|Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Percentages of subjects||95% Confidence Interval|Number
22947|NCT01717638|Secondary|Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity.||Percentages of subjects||95% Confidence Interval|Number
22958|NCT01717456|Other Pre-specified|Patient's Living Situation at End of Treatment|OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment||participants|||Number
44908|NCT01388816|Secondary|Safety and Tolerability of DRL-17822|Incidence of treatment-related adverse events|28 days|Safety/ITT Population||participants|||Number
22948|NCT01717638|Secondary|Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Ratio||95% Confidence Interval|Geometric Mean
22949|NCT01717638|Secondary|GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
22950|NCT01717638|Secondary|Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.||Percentages of subjects||95% Confidence Interval|Number
22951|NCT01717638|Secondary|GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency.||Ratio||95% Confidence Interval|Geometric Mean
22952|NCT01717638|Secondary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.|Day 1 (22-36 months post last MenB vaccine; baseline for naive)|FAS, Persistency.||Titers||95% Confidence Interval|Geometric Mean
22953|NCT01717638|Secondary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.||Percentages of subjects||95% Confidence Interval|Number
22954|NCT01717638|Primary|Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.|Day 1 (24-36 months post booster dose; baseline for naive)|FAS, Persistency.||Ratio||95% Confidence Interval|Geometric Mean
22955|NCT01717638|Primary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).|Day 1 (24-36 months post booster; baseline for naive)|FAS, Persistency.||Titers||95% Confidence Interval|Geometric Mean
22956|NCT01717638|Primary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|"The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.~The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA)."|Day 1 (24-36 months post booster; baseline for naive)|Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.||Percentages of subjects||95% Confidence Interval|Number
22957|NCT01717456|Other Pre-specified|Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment|"OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from No assistance needed in this area to Assistance needed, but no Caregivers available. Ordinal scale with 6 levels:~0= No assistance needed~Caregiver provides assistance~Caregiver needs training or support~Caregiver is unlikely to provide assistance~Unclear if caregiver will assist patient~Assistance is needed but is not available"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment||units on a scale||Full Range|Median
22959|NCT01717456|Other Pre-specified|Depression Screening at End of Treatment|"OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:~0= No screening~Screened for depression with PHQ2 measure~Screened with PHQ2 and meets criteria for further evaluation of depression~Screened and does not meet criteria for further evaluation of depression"|End of Treatment (Week 6)|Analysis population consists of all patients providing data at end of treatment.||participants|||Number
22960|NCT01717456|Other Pre-specified|When is Patient Anxious at End of Treatment?|"OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:~0 - None of the time~- Less often than daily~- Daily, but not constantly~- All of the time"|End of Treatment (Week 6)|Analysis population consists of all patients who provided end of treatment data.||units on a scale||Full Range|Median
22961|NCT01717456|Other Pre-specified|Ability to Reach Toilet at End of Treatment|"OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.~A lower score is better.~Responses:~0. Able to get to and from the toilet and transfer independently with or without a device.~When reminded, assisted, or supervised by another person, able to get to and from the toilet.~Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).~Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.~Is totally dependent in toileting."|End of Treatment (Week 6)|All patients who provided data for this measure at the end of treatment.||units on a scale||Full Range|Median
22962|NCT01717456|Other Pre-specified|Change in Ambulation From Baseline to End of Treatment|"OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:~0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).~Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.~Able to walk only with the supervision or assistance of another person at all times.~Chairfast, unable to ambulate but is able to wheel self independently.~Chairfast, unable to ambulate and is unable to wheel self.~Bedfast, unable to ambulate or be up in a chair.~Higher scores represent improvement in ability to ambulate."|Baseline, End of Treatment (Week 6)|Analysis sample consists of all patients who provided data for this questionnaire at the end of treatment. Two EMB subjects did not provide this data for unknown reasons, and 4 SC subjects did not provide this data for unknown reasons.||units on a scale||Full Range|Median
22963|NCT01717456|Other Pre-specified|Cognitive Status at End of Treatment|"OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:~0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.~- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.~- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.~- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.~- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium."|End of Treatment (Week 6)|Analysis population is all patients who provided data on this measure at end of treatment. Data were missing for 2/11 in Group A and 6/8 in Group B.||units on a scale||Full Range|Median
22964|NCT01717456|Secondary|MHQ Sleep Energy at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22965|NCT01717456|Secondary|MHQ Sleep Energy at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22966|NCT01717456|Secondary|MHQ Emotions at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22967|NCT01717456|Secondary|MHQ Emotions at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22968|NCT01717456|Secondary|MHQ Personal Relationships at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22969|NCT01717456|Secondary|MHQ Personal Relationships at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22970|NCT01717456|Secondary|MHQ Social Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22971|NCT01717456|Secondary|MHQ Social Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22972|NCT01717456|Secondary|MHQ Physical Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22973|NCT01717456|Secondary|MHQ Physical Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22974|NCT01717456|Secondary|MHQ Role Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22975|NCT01717456|Secondary|MHQ Role Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22976|NCT01717456|Secondary|MHQ Incontinence Impact at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22977|NCT01717456|Secondary|MHQ Incontinence Impact at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22978|NCT01717456|Secondary|Admission to Nursing Home at End of Treatment|Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.|End of Treatment (Week 6)|Analysis sample was all patients who provided data at end of treatment.||participants|||Number
22979|NCT01717456|Secondary|Urinary Incontinence Status Change From Baseline to End of Treatment|"OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:~0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)~- Patient is incontinent~- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)"|Baseline, end of treatment (week 6)|Analysis population consists of all patients who provided end of treatment data. Data were missing for 2/11 in Group A and 6/8 in Group B.||units on a scale||Full Range|Median
22980|NCT01717456|Secondary|Fecal Incontinence Frequency at End of Treatment|"OASIS question M1620: Bowel incontinence frequency. Response options are:~0 - Very rarely or never has bowel incontinence~- Less than once weekly~- One to three times weekly~- Four to six times weekly~- On a daily basis~- More often than once daily"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at the end of treatment visit. Data is missing for 2/11 in Group A and 6/8 in Group B.||units on a scale||Full Range|Median
22981|NCT01717456|Secondary|Zarit Caregiver Burden Scale at Follow Up|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.|6 months after (6-Week) treatment ends|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.||units on a scale||Standard Deviation|Mean
22982|NCT01717456|Secondary|Zarit Caregiver Burden Scale at End of Treatment|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.|End of Treatment (Week 6)|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.||units on a scale||Standard Deviation|Mean
22983|NCT01717456|Secondary|MHQ Severity Scale at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22984|NCT01717456|Secondary|MHQ Severity Scale at End of Treatment|Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.||units on a scale||Standard Deviation|Mean
22985|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at Follow Up|"At follow up 6 months after the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder to treatment is a subject who answers yes. When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided."|6 months after (6-Week) treatment ends|Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.||participants|||Number
22986|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at End of Treatment|"At the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups."|End of Treatment (Week 6)|Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.||participants|||Number
22987|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)|At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.|6 months after (6-Week) treatment ends|The analysis sample consists of all patients who provided data at the 6 month FU visit.||units on a scale||Standard Deviation|Mean
22988|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at End of Treatment|At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.|End of Treatment (Week 6)|Analysis population includes all participants who provided end of treatment data to research assistants during a home visit. One subject from the EMB treatment did not provide data, and 1 subject from the SC group did not provide these data.||units on a scale||Standard Deviation|Mean
22989|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after end of therapy (up to 42 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
22990|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|4 weeks after end of therapy (up to 22 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
22991|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.||percentage of participants||95% Confidence Interval|Number
22992|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
22993|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
22994|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.||percentage of participants||95% Confidence Interval|Number
23055|NCT01716234|Secondary|Number of Participants With an Adverse Event Leading to Study Drug Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 28|The population analyzed was all treated participants.||Participants|||Number
22995|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
22996|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
22997|NCT01717326|Secondary|Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)|FAS; all randomized participants who received ≥1 dose of study treatment.||days||Standard Error|Mean
22998|NCT01717326|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|APaT population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).||percentage of participants||95% Confidence Interval|Number
22999|NCT01717326|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).||percentage of participants||95% Confidence Interval|Number
23000|NCT01717326|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after end of therapy (up to 30 weeks)|The Per-Protocol (PP) population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.||percentage of participants||95% Confidence Interval|Number
23001|NCT01717313|Post-Hoc|Change From Baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).||mg/dL||95% Confidence Interval|Least Squares Mean
23002|NCT01717313|Post-Hoc|Change From Baseline in FPG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).||mg/dL||95% Confidence Interval|Least Squares Mean
23003|NCT01717313|Post-Hoc|Change From Baseline in A1C at Week 24 (Phase A, Per-Protocol Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).||Percent||95% Confidence Interval|Least Squares Mean
23004|NCT01717313|Secondary|Change From Baseline in FPG at Week 54 (Phase A + Phase B, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
23005|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 54.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
23006|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 54 (Phase A + Phase B, FAS Population)|"The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 54.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
23007|NCT01717313|Secondary|Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
23008|NCT01717313|Secondary|Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
23009|NCT01717313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
23010|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 24.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
23270|NCT01712776|Primary|Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)|NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)|Less than 10 minutes after stream application.|equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups||units on a scale||Standard Deviation|Mean
23011|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 24.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.||Percentage of participants||95% Confidence Interval|Number
23012|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
23013|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
23014|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 24 weeks|The APaT population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
23015|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 27 weeks|The All-Participants-as-Treated (APaT) population included all participants who received at least one dose of study drug.||Percentage of participants|||Number
23016|NCT01717313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population)|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The Full Analysis Set (FAS) population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
23017|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation||Percentage of participants||95% Confidence Interval|Number
23018|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <40 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation||Percentage of participants||95% Confidence Interval|Number
23019|NCT01717287|Secondary|Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had at least one postbaseline evaluation||Percentage of participants||95% Confidence Interval|Number
23271|NCT01712711|Primary|Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment||8 weeks|||percentage of liver fat content||Standard Deviation|Mean
23020|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
23021|NCT01717287|Primary|Percentage of Participants With at Least One Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
23022|NCT01717287|Secondary|Change From Baseline in CD4 Cell Percentage|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation||Percentage change||95% Confidence Interval|Mean
23023|NCT01717287|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation||cells/mm^3||95% Confidence Interval|Mean
23024|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
23025|NCT01717287|Primary|Percentage of Participants With at Least One Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug||Percentage of participants|||Number
23026|NCT01717040|Primary|Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms|Baseline and Week 8|||units on a scale||Standard Error|Least Squares Mean
23027|NCT01717014|Secondary|Usability: Manueverability|Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate|Operatively|||% of cases surgeon agree/strongly agree|||Number
23028|NCT01717014|Secondary|Usability: Access|Access measured by surgeon usability questionnaire|Operatively|||% of cases surgeon agree/strongly agree|||Number
23029|NCT01717014|Secondary|Usability: Visibility|Visibility measured by surgeon usability questionnaire.|Operatively|||% of cases surgeon agree/strongly agree|||Number
23030|NCT01717014|Primary|Distal Margins|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative|||participants|||Number
23031|NCT01717014|Primary|Staple Line|The surgeons ability to achieve a staple line at the desired level of the rectum.|Operative|||participants|||Number
23032|NCT01716663|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time RF is delivered during the procedure.|Day 0|Patients with non-missing RF application time.||minutes||Standard Deviation|Mean
23033|NCT01716663|Secondary|Mean Number of Radiofrequency (RF) Applications|RF application is defined as the number of times RF energy is delivered during the procedure.|Day 0|Patients with non-missing RF application values||number of applications||Standard Deviation|Mean
23034|NCT01716663|Secondary|Acute Procedural Success|Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.|Day 0|Acute effectiveness and efficiency cohort||participants|||Number
23035|NCT01716663|Secondary|Total Procedure Time|The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|The number of patients with non-missing procedure time data.||minutes||Standard Deviation|Mean
23036|NCT01716663|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|Those patients with non-missing fluoroscopy time.||minutes||Standard Deviation|Mean
23037|NCT01716585|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
23056|NCT01716234|Secondary|Number of Participants With an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 58|The population analyzed was all treated participants.||Participants|||Number
23038|NCT01716585|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
23039|NCT01716585|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug.||percentage of participants|||Number
23040|NCT01716585|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug.||percentage of participants|||Number
23041|NCT01716585|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.||percentage of participants|||Number
23042|NCT01716585|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.||percentage of participants|||Number
23043|NCT01716559|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 16|The analysis was performed on total population.||participants|||Number
23044|NCT01716559|Secondary|Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy|"Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as 1 denotes an effect on the response of treatment with or without iron replacement therapy. Response value as 0 denotes no effect on the response of treatment with or without iron replacement therapy."|Up to Week 16|The analysis was performed on total population. At the end of the study, data allowing the evaluation of effect of individual iron supplementation on the efficacy of Epoetin beta treatment were available for 103 participants out of total population of 160.||participants|||Number
23045|NCT01716559|Secondary|Percentage of Red Blood Cell Transfusion-free Participants|Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.|Up to Week 16|The analysis was performed on Total population.||percentage of participants||95% Confidence Interval|Number
23046|NCT01716559|Secondary|Mean Change From Baseline in Hemoglobin Level up to Week 16|The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.|Baseline, Week 4, Week 8, Week 12, and Week 16|"The analysis was performed on Total population. The n signifies the number of participants assessed for mean change in hemoglobin level for specified time point."||g/dL||Standard Error|Mean
23047|NCT01716559|Primary|Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8|Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.|Baseline to Week 8|The analysis was performed on total population. At the end of the Week 8, data allowing the evaluation of the therapeutic response was available for 103 participants out of total population of 160.||percentage of participants||95% Confidence Interval|Number
23057|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.|Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.||ng/mL||Standard Deviation|Mean
23048|NCT01716520|Secondary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 84)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
23049|NCT01716520|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 83)|ITT Population. Only those participants available at the specified time point were analyzed.||participants|||Number
23050|NCT01716520|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.’s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)|ITT Population||participants|||Number
23051|NCT01716520|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.|Baseline and Day 14 of each treatment period (up to study day 83)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
23052|NCT01716468|Primary|To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.|Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.|16 weeks|Solid cancers or blood cancers with measurable components in advanced or metastatic stages.||participants|||Number
23053|NCT01716455|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.||ng/ml||Standard Deviation|Mean
23054|NCT01716455|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.||ng*hr/ml||Standard Deviation|Mean
24138|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
23058|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.|Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.||ng/mL||Standard Deviation|Mean
23059|NCT01716221|Other Pre-specified|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)|||units on a scale|||Number
23060|NCT01716221|Secondary|Comparison of FARS and ICARS|Differences between FARS - ICARS at each treatment interval|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)|||points|||Number
23061|NCT01716221|Primary|Friedreich Ataxia Rating Scale (FARS)|A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)|||points|||Number
23062|NCT01716221|Primary|International Cooperative Ataxia Rating Scale (ICARS)|The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)|||units|||Number
23063|NCT01716169|Primary|Percentage of Wound Surface Area Change From Baseline to Week 8|Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.|Baseline and Week 8|||percentage of wound surface area||95% Confidence Interval|Mean
23064|NCT01716156|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy.|Up to Week 48|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
23065|NCT01716156|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy.|Up to Week 28|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
23066|NCT01716156|Secondary|Percentage of Participants With HCV RNA <25 IU/mL by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
23067|NCT01716156|Secondary|Percentage of Participants With Undetectable HCV RNA by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
23068|NCT01716156|Secondary|Time to Achievement of First Undetectable HCV RNA|The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|Up to Week 24|Full analysis set consists of all randomized participants receiving ≥1 dose of study therapy.||Days||Standard Error|Mean
23089|NCT01715896|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23796|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set||rescue medication free days||90% Confidence Interval|Least Squares Mean
23069|NCT01716156|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Up to 24 weeks|The APaT population included all randomized participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
23070|NCT01716156|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Fourteen days following last dose of study drug (up to 26 weeks)|The All Participants as Treated (APaT) population included all randomized participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
23071|NCT01716156|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|Up to Week 36|Per protocol population, as randomized. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.||Percentage of participants||95% Confidence Interval|Number
23072|NCT01716052|Primary|Measure of Discomfort of Mammography|The primary outcome measure will be the response to questions on a questionnaire.|3 years|No data was collected or analyzed for the outcome measure because the study was terminated.|||||
23073|NCT01716013|Other Pre-specified|Wound Dehiscence Requiring Treatment|Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up|28 Days and 90 days|Intent-to-Treat (ITT) population||percentage of participants|||Number
23074|NCT01716013|Secondary|≥ 50% Wound Apposition at 10 Days|Incidence of wounds ≥50% apposed (10 ± 3 days)|10 days|Intent-to-treat (ITT) population||percentage of participants|||Number
23075|NCT01716013|Secondary|Optimal Cosmetic Outcome at 28 Days (Score of 6)|"Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.~One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:~Stepoff of borders (edges not on the same plane)~Contour irregularities (wrinkled skin near wound)~Margin separation (gap between sides)~Edge inversion (wound not properly everted)~Excessive distortion (swelling or edema or infection)~Poor overall appearance.~The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal."|28 days|Intent-to-treat (ITT) population||percentage of participants|||Number
23076|NCT01716013|Primary|100% Wound Apposition at 10 Days|Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.|10 days|Per protocol population (primary analysis dataset)||percentage of participants|||Number
23077|NCT01715948|Primary|Speech Spatial Qualities Questionnaire (SSQ)|"The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined."|Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.|||units on a scale||95% Confidence Interval|Mean
23078|NCT01715948|Primary|Percentage of Words Recognized|Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.|Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..|The researchers chose not to include a condition with words presented at 90 degrees to the better ear in quiet.||Percentage of words perceived correctly||95% Confidence Interval|Mean
23090|NCT01715896|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23079|NCT01715948|Primary|Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise|One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.|The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).|||words||95% Confidence Interval|Mean
23080|NCT01715896|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.||participants|||Number
23081|NCT01715896|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after subcutaneous dose of mavrilimumab were calculated|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each this arm respectively."||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
23082|NCT01715896|Secondary|Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure. n'' signifies participants evaluable for specified category for each arm, respectively."||millimeter per hour (mm/h)||Standard Deviation|Geometric Mean
23083|NCT01715896|Secondary|Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline|The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."||ratio||Geometric Coefficient of Variation|Geometric Mean
23084|NCT01715896|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
23085|NCT01715896|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||centimeter (cm)||Standard Error|Mean
23086|NCT01715896|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||mm||Standard Error|Mean
23087|NCT01715896|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||millimeter (mm)||Standard Error|Mean
23088|NCT01715896|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||joint count||Standard Error|Mean
23091|NCT01715896|Secondary|Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23092|NCT01715896|Secondary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169|The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23093|NCT01715896|Secondary|Duration of DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."||days||Standard Error|Mean
23094|NCT01715896|Secondary|Time to Onset DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."||days||90% Confidence Interval|Median
23095|NCT01715896|Secondary|Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||participants|||Number
23096|NCT01715896|Secondary|Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||participants|||Number
23097|NCT01715896|Secondary|American College of Rheumatology (ACR) Hybrid Score at Day 169|ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||units on a scale||Full Range|Median
23098|NCT01715896|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
23107|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|The ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23099|NCT01715896|Secondary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively"||units on a scale||Standard Deviation|Mean
23100|NCT01715896|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale was a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.|Day 169|"The safety population included all participants who received any amount of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
23101|NCT01715896|Secondary|Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (>) 20% reduction (RD) and absolute value (AV) less than (<) 80% predicted (PR).|Day 85 and 169|"The safety population included all participants who received any amount of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."||participants|||Number
23102|NCT01715896|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.||participants|||Number
23103|NCT01715896|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.|Baseline up to Day 169|The safety population included all participants who received any amount of investigational product.||participants|||Number
23104|NCT01715896|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.||participants|||Number
23105|NCT01715896|Primary|Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169|The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23106|NCT01715896|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23147|NCT01715129|Secondary|Plasma Triptorelin Levels (Cmin)|Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.|At Day 92 and 183|ITT population. No samples were collected from 4 subjects at Day 92 and 9 subjects at Day 183||ng/mL||Standard Deviation|Mean
23804|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set||Asthma symptom free days||90% Confidence Interval|Least Squares Mean
23108|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|The ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23109|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|The ACR20 was defined as greater than or equal to (>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23110|NCT01715857|Secondary|Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus|Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 – 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.||percentage of timepoints|Participants||Number
23111|NCT01715857|Secondary|Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus|Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.||percentage of timepoints|Participants||Number
23112|NCT01715857|Secondary|Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)|Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.|Anesthetic duration between 1 to 5 hours|All participants who received study drug and with available data.||Yuan renminbi [RMB]/hour||Standard Deviation|Mean
23113|NCT01715857|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.|From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes|All participants who received study drug and with available data.||minutes||Standard Deviation|Mean
23114|NCT01715857|Secondary|Time to Eye Opening|After cessation of anesthesia, the investigators lightly tapped on the participant’s forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.|From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes|All participants who received study drug and with available data.||minutes||Standard Deviation|Mean
23115|NCT01715857|Primary|Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).|24 hours after end of surgery|All participants who received study drug and with available data.||scores on a scale||Standard Deviation|Mean
23116|NCT01715857|Primary|Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.|End of surgery|||scores on a scale||Standard Deviation|Mean
23117|NCT01715415|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
23118|NCT01715415|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.||percentage of participants||95% Confidence Interval|Number
23119|NCT01715415|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.||percentage of participants|||Number
23120|NCT01715415|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.||percentage of participants|||Number
23121|NCT01715415|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.||percentage of participants|||Number
23122|NCT01715415|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.||percentage of participants|||Number
23123|NCT01715298|Secondary|Change From Baseline in Morning and Nighttime Symptom Scores|Patients are reporting morning and nighttime symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Morning and nighttime symptoms scores for each patient over 12 weeks are reported and analyzed. Symptom scores are calculated as the mean of the symptom scores (morning symptom scores or nighttime symptom scores, respectively) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The outcome is calculated as the change from baseline in the morning and nighttime symptom scores, respectively. A negative number indicates a reduction in the symptom severity and is owed to the calculation of the change from baseline.|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Score||Standard Error|Least Squares Mean
23124|NCT01715298|Secondary|Change From Baseline in Mean Trough Forced Vital Capacity|Mean trough Forced Vital Capacity (FVC) is assessed as the arithmetic mean of two FVC measurements, conducted within the last hour of a 24 hours period from a morning dose, either that of day 1 or at week 12 of treatment (23:15 h and 23:45 h assessments). The endpoints are the change from baseline in trough FVC on Day 1 and at Week 12, with the mean of the -45 min and -15 min measurements on Day 1 as the baseline.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Liters||Standard Error|Least Squares Mean
23125|NCT01715298|Secondary|Change From Baseline in Forced Vital Capacity at All Individual Timepoints|The Forced Vital Capacity (FVC)assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Serial lung function measurements are taken at the following time points following dosing on Day 1 and at week 12: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. For week 12 (day 85), the pre-dose measurements (-45 min and -15 min) and the trough measurements (23:15 h and 23:45 h post-dose) are included. The endpoints are the change from baseline in FVC following the morning dose on Day 1 and at Week 12. Where the FVC at any one timepoint is smaller than at baseline, a negative value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Liters||Standard Error|Least Squares Mean
23126|NCT01715298|Secondary|"Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the evening questionnaire relates to the impact of COPD symptoms on the performance of usual daily activities (“Did your respiratory symptoms stop you performing your usual daily activities today“). The answer with the lowest symptom score is “not at all.” A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The change from baseline in the percentage of “days able to perform usual daily activities” is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline beingThe baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Percentage of days||Standard Error|Least Squares Mean
23127|NCT01715298|Secondary|"Change From Baseline in the Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours in the evening questionnaire. The change from baseline in the percentage of days with “no daytime symptoms” is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline being. The baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Percentage of days||Standard Error|Least Squares Mean
23128|NCT01715298|Secondary|"Change From Baseline in the Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the morning questionnaire relates to the number of awakenings due to COPD symptoms during the previous night. The answer with the lowest symptom score is “no waking due to symptoms.” A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. The change from baseline in the percentage of nights with “no nighttime awakening” is calculated from the mean percentage of nights with this answer over the 12 week treatment period, with the baseline being The baseline is calculated from the run-in epoch prior to randomization."|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Percentage of nights||Standard Error|Least Squares Mean
23129|NCT01715298|Secondary|Change From Baseline in Daily Symptom Scores|Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Symptom scores are calculated as the mean of the combined daily symptom scores (combined from morning and evening scores) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The change from baseline in the least squares mean daily symptom scores over the 12 week treatment period is provided. Where the mean daily symptom score over the 12 week treatment period is lower than the baseline, the result is negative. A negative result indicates an improvement in COPD symptom severity.|day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||Score||Standard Error|Least Squares Mean
23130|NCT01715298|Secondary|Change From Baseline in the Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated as the percentage of days without usage of rescue medication from during the the run-in epoch prior to randomization.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||percentage of days||Standard Error|Least Squares Mean
23131|NCT01715298|Secondary|Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the mean daily number of puffs used per patient over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization (mean number of puffs per day). A negative number indicates a reduction in the mean daily number of puffs of rescue medication.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||Number of puffs||Standard Error|Least Squares Mean
23132|NCT01715298|Secondary|Breathlessness Assessed by Transition Dyspnea Index|Breathlessness at week 12 is measured using the interviewer-administered Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the interviewer-administered Baseline Dyspnea Index (BDI). The change from BDI to TDI is assessed, with the TDI total score ranging from -9 to +9 units of the scale. The lower the score, the more deterioration in severity of dyspnea. Patients are considered to have clinically significant improvement (MCID) with the TDI score change versus BDI being equal to or greater than 1.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||Score||Standard Error|Least Squares Mean
23133|NCT01715298|Secondary|Change From Baseline in the Health Status Assessed by St. George’s Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||Score||Standard Error|Least Squares Mean
23134|NCT01715298|Secondary|Mean Trough Forced Expiratory Volume in One Second|Mean trough Forced Expiratory Volume in one second (FEV1) is assessed as the arithmetic mean of two FEV1 measurements, conducted within the last hour of a 24 hour period from a morning dose, either that of day 1 or at week 12 of treatment. The data is reported as the change from baseline (CFB), with the baseline being the arithmetic mean of the two pre-dose measurements (-45 min and -15 min) preceding the serial lung function measurements on Day 1|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||Liters||Standard Error|Least Squares Mean
23148|NCT01715129|Secondary|Time to Achieve Castration (Tcast)|Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)|Up to Day 36|ITT population||Day||95% Confidence Interval|Median
23135|NCT01715298|Secondary|Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Time points of the serial lung function measurements are 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The table indicates the percent change from baseline (CFB) in FEV1 and standard deviation in brackets. Where the FEV1 is lower than at baseline, a negative percent value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||Percent||Standard Deviation|Mean
23136|NCT01715298|Secondary|Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1FEV1) is assessed for different time spans (0-4 h, 4-8 h, 8-12 h) within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various the following time points post dosing on day 1 and at week 12 to calculate the FEV1 AUC for these different time spans: .5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 or week 12, respectively, (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1 and Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||Liters||Standard Error|Least Squares Mean
23137|NCT01715298|Secondary|Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is assessed at day 1 of treatment. Serial lung function measurements are taken at the following various time points post dosing at day 1 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~.The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1||Liters||Standard Error|Least Squares Mean
23138|NCT01715298|Primary|Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean FEV1 change from baseline (CFB) over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur"|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||Liters||Standard Error|Least Squares Mean
23139|NCT01715129|Secondary|Cmin of Triptorelin in Subset of 18 Subjects||At Day 92 and 183|Day 92: Four subjects (presenting particularly high levels of triptorelin) were excluded from 18-subject subset.||ng/mL||Standard Deviation|Mean
23140|NCT01715129|Secondary|Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.||h*ng/mL||Standard Deviation|Mean
23141|NCT01715129|Secondary|Peak Plasma Concentration Value (Cmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.||ng/mL||Standard Deviation|Mean
23142|NCT01715129|Secondary|Time to Cmax (Tmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|Pharmacokinetic (PK) profile was assessed in a subset of 18 subjects.||Hours||Full Range|Median
23143|NCT01715129|Secondary|Percentage of Subjects With Adverse Events||Up to Day 183|All subjects who received at least one dose of study treatment were included in safety population.||Percentage of subjects|||Number
23144|NCT01715129|Secondary|Clinically Apparent Tumor Progression|Tumour progression was recorded according to the Investigator’s clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).|Day 92 and 183|ITT population||participants|||Number
23145|NCT01715129|Secondary|Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)|"0-4 ng/mL (normal PSA value)~>4 ng/mL (abnormal PSA levels)"|At Day 183|Subjects completed Day 183 visit (End of Study)||Percentage of subjects|||Number
23146|NCT01715129|Secondary|Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects|Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.|From Day 1 (Baseline) to Day 183 (End of study)|ITT population at End of Study (Day 183). One subject had no data.||Percentage Change||Standard Deviation|Mean
23166|NCT01714492|Secondary|Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative|||MPa|Participants|Standard Deviation|Mean
24163|NCT01699373|Secondary|Time Taken to Perform Spinal Anaesthesia||During procedure||||||
23149|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95|Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|Day 95|IC1 population.||Percentage of subjects||95% Confidence Interval|Number
23150|NCT01715129|Secondary|Probability of Testosterone <50 ng/dL|"Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.~LC-MS/MS: Liquid Chromatography–Tandem Mass Spectrometry"|Day 29 through Day 183|Intention-to-treat (ITT) population: All treated subjects||Proportion of subjects||95% Confidence Interval|Number
23151|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose|Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|At Day 92|Initially Castrated (IC1) population: All treated subjects with testosterone levels <50 ng/dL at Day 29 or at Day 36, assessed with the LC-MS/MS method and missing data imputed by immunoassay method.||Percentage of subjects||95% Confidence Interval|Number
23152|NCT01715129|Primary|Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183|Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183|At Day 29 and 183|N=Number of subjects attending the visit||Percentage of subjects||95% Confidence Interval|Number
23153|NCT01715064|Secondary|Exercise-Induced Feelings Inventory - Questionnaire (EIFI)|Correlations will be assessed between cortical silent period and exercise-induced feelings.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
23154|NCT01715064|Secondary|Hospital Anxiety and Depression Scale - Questionnaire(HADS)|Correlations will be assessed between cortical silent period and acute anxiety and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
23155|NCT01715064|Secondary|State-Trait Anxiety Inventory - Questionnaire(STAI)|Correlations will be assessed between cortical silent period and acute anxiety.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
23156|NCT01715064|Secondary|Profile of Mood States Questionnaire(PoMS)|Correlations will be assessed between cortical silent period and acute mood state.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||||
23157|NCT01715064|Primary|Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.|CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||seconds||Standard Deviation|Mean
23158|NCT01714635|Secondary|Spectacle Independence|Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.|six months|Five subjects (3 from Group #1 [145-142], 1 from Group #2 [150-149], and 1 from the monofocal control group [146-145]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.||participants|||Number
23159|NCT01714635|Secondary|Mean Diopter Range With VA of 20/40 or Better|"Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.~* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively."|six months|eyes||diopters||Standard Deviation|Mean
23160|NCT01714635|Primary|Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm|Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative|six months|eyes||LogMAR VA||Standard Deviation|Mean
23161|NCT01714609|Primary|Patients With Change in HVPG From Baseline|Number of participants with a decrease in HPVG that was > 10% of baseline|Three Months|||participants|||Number
23162|NCT01714544|Primary|Investigator's Global Assessment (IGA)|The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).|28 days|Intent to treat population, with LOCF for missing data||percentage of subjects||95% Confidence Interval|Number
23163|NCT01714505|Primary|Safety, Frequency of Hypoglycemia|Hypoglycemic episodes are defined as BG < 3.9mmol/L|40 hours (x 2 admissions)|||hypoglycemic episodes/participant||Standard Deviation|Mean
23164|NCT01714505|Secondary|Efficacy, Time Spent in Target Range|Percentage of time in the target range of 3.9–10 mmol/L (70–180 mg/dL).|40 hours (x2 admissions)|||percentage of time spent in range||Standard Deviation|Mean
23165|NCT01714505|Primary|Safety, Low Blood Glucose Index (LBGI)|"The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in “risk space.” Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes.~LBGI < 2.5 is associated with low risk of hypoglycemia, 2.5 < LBGI < 5 is associated with a moderate risk of hypoglycemia and LBGI > 5 is associated with a high risk of hypoglycemia."|40 hours (x2 admissions)|||index score||Standard Deviation|Mean
23170|NCT01714492|Secondary|In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity|"The intended unit of measure is times Body Weight (or xBW), relating to a ratio."|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation||times body weight|Participants|Standard Deviation|Mean
23171|NCT01714492|Primary|In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity|The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.||mm|Participants|Standard Deviation|Mean
23172|NCT01714336|Secondary|Number of Participants Who Died|All-cause mortality at 6 months|6 months after surgery|||participants|||Number
23173|NCT01714336|Secondary|Number of Participants With Cerebrovascular Accident (CVA) Diagnosis|CVA diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
23174|NCT01714336|Secondary|Number of Participants With Myocardial Infarction (MI) Diagnosis|MI diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
23175|NCT01714336|Secondary|Number of Participants With Wound Complications|Wound complications diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
23176|NCT01714336|Secondary|Number of Participants With Venous Thromboembolism (VTE) Diagnosis|Incidence of symptomatic VTE diagnosed within 6 months of surgery|Within 6 months of surgery|||participants|||Number
23177|NCT01714336|Secondary|Calculated Blood Loss|Calculated blood loss|5 days|||cc||Standard Deviation|Mean
23178|NCT01714336|Secondary|Mean Number of Units Transfused|Mean number of units transfused per patient|5 days|||units/participant transfused||Standard Deviation|Mean
23179|NCT01714336|Primary|Number of Participants Who Received a Hospitalization Transfusion|Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission|5 days|||participants|||Number
23180|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with Blood Glucose >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL.||Percent Difference|Participants|Standard Error|Mean
23181|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose (BG) <=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL.||Percent Difference|Participants|Standard Error|Mean
23182|NCT01714232|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed.||Percent Difference||Standard Error|Mean
23183|NCT01713998|Secondary|Subject Assessment of Improvement at 180 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|180 days post-treatment|||percentage of participants|||Number
23184|NCT01713998|Secondary|Subject Assessment of Improvement at 90 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|90 days post-treatment|||percentage of participants|||Number
23185|NCT01713998|Secondary|Quantitative Assessment of Brow Lift at 90 Days Post-treatment|Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.|90 days post-treatment|||Participants|||Number
23186|NCT01713998|Primary|Overall Improvement in Skin Laxity on the Face and Neck|A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.|90 days post-treatment|||Participants|||Number
23187|NCT01713998|Primary|Subjects' Assessment of Pain During Treatment With Lower Energy Settings|"Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.~Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed."|Participants were assessed for the duration of study treatment, an average of 75 minutes|||units on a scale||Full Range|Mean
23188|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Percentage of Participants|||Number
23189|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 90 days post-treatment|wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||Percentage of Participants|||Number
23190|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Percentage of Participants|||Number
23191|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||Percentage of Participants|||Number
23192|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 60 days post-treatment|Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Percentage of Participants|||Number
23193|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.||Millimeters||Full Range|Mean
23194|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||Millimeters||Full Range|Mean
23195|NCT01713933|Secondary|Quantitative Improvement in Skin Laxity|Assess change in brachial volume based on brachial tissue measurements.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||percentage of participants improved|||Number
23196|NCT01713933|Primary|Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity|Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.||percentage of participants improved|||Number
23197|NCT01713686|Secondary|Subject Satisfaction at 180 Days Post-treatment|"Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:~Very Satisfied~Satisfied~Neither Satisfied or Dissatisfied~Dissatisfied~Very Dissatisfied~Satisfied = Very Satisfied + Satisfied~Dissatisfied = Dissatisfied + Very Dissatisfied"|180 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit.||percentage of participants|||Number
23198|NCT01713686|Secondary|Subject Satisfaction at 90 Days Post-treatment|"Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:~Very Satisfied~Satisfied~Neither Satisfied or Dissatisfied~Dissatisfied~Very Dissatisfied~Satisfied= Very Satisfied + Satisfied~Dissatisfied=Dissatisfied + Very Dissatisfied"|90 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit.||percentage of participants|||Number
23199|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.~Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.~Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|180 days post treatment|The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.||percentage of participants|||Number
23200|NCT01713686|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:~Very much improved~Much improved~Improved~No change~Worse~The scale was completed in two steps:~Based on a live assessment of the subject while referring to the subject’s pre-treatment photographs; and~Based on a comparison of the subject’s pre-treatment photographs to current post-treatment photographs.~Improved = Very Much Improved + Much Improved + Improved"|180 days post-treatment|Analysis population was based the number of subjects completing a 180 day follow-up visit.||percentage of participants|||Number
23201|NCT01713686|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:~Very much improved~Much improved~Improved~No change~Worse~The scale was completed in two steps:~Based on a live assessment of the subject while referring to the subject’s pre-treatment photographs; and~Based on a comparison of the subject’s pre-treatment photographs to current post-treatment photographs.~Improved = Very Much Improved + Much Improved + Improved"|90 days post-treatment|This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.||percentage of participants|||Number
23202|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.~Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.~Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|90 Days post-treatment|The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as ‘missing’ by the statistician and were not included in the denominator for the masked assessment analyses.||percentage of participants|||Number
23203|NCT01713660|Secondary|Percent of Seidel Staining|Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.|Day 0 (performed immediately post-incision creation), Day 1|||percentage of eyes with negative Seidel|Participants||Number
23204|NCT01713660|Secondary|Surgeon Assessment of Workflow|Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?|Day 0, Operative|||percentage of yes answers|||Number
23205|NCT01713660|Primary|Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.|Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).|Day 0, Operative (Within 2 hours of incision creation)|||mm|Participants|Standard Deviation|Mean
23206|NCT01713621|Primary|Minimum Inhibitory Concentration (MIC)|The estimated MIC and MPC were derived from the fitted parasitaemia concentration and PK/PD relationship.|up to 28 days|Model predicted MIC||ng/Ml||Standard Deviation|Mean
23207|NCT01713608|Secondary|OZ439 t½|OZ439 estimated terminal phase half life|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||hours||Standard Deviation|Mean
23208|NCT01713608|Primary|OZ439 AUCτ|OZ439 Area under the plasma concentration vs time curve from time zero to the time of the last quantifiable concentration t calculated using a log-linear trapezoidal method|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||ng*h/mL||Standard Deviation|Mean
23209|NCT01713608|Secondary|OZ439 Tmax|Time to reach maximum measured OZ439 plasma concentration|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||hours||Standard Deviation|Mean
24164|NCT01699373|Primary|Success Rate of First-attempt of Spinal Anaesthesia||During procedure|||participants|||Number
23210|NCT01713608|Primary|OZ439 Cmax|OZ439 maximum measured plasma concentration|Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.||ng/mL||Standard Deviation|Mean
23211|NCT01713530|Secondary|Incidence of Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||number of events|||Number
23212|NCT01713530|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
23213|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:~Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia"|During Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
23214|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))|During Weeks 0-26|The safety Analysis Set (SAS): included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.||episodes|||Number
23215|NCT01713530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects (2 subjects-baseline FPG not measured). The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.||mmol/L||Standard Error|Least Squares Mean
23216|NCT01713530|Primary|Change From Baseline in HbA1c (%)|Change from baseline in HbA1c (%) after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.||percentage change in HbA1c||Standard Error|Least Squares Mean
23217|NCT01713400|Secondary|Incidence of Acute Graft vs. Host Disease (AGVHD)|Cumulative incidence of Grade II – IV AGVHD to be characterized weekly from day of transplant to day 100 using the 1995 updated grading scheme for Graft vs. Host Disease (GVHD) developed by Glucksberg, et al.|100 days post transplant|All participating recipients||percentage of participants|||Number
23218|NCT01713400|Primary|T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio|"Median Blood Treg/Total CD4+ Ratio at day 30 following hematopoietic cell transplantation (HCT). Comparison between study arms: Ustekinumab vs. Placebo. From NCI Dictionary: T reg - A type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. T regs are being studied in the treatment of cancer. A T reg is a type of white blood cell and a type of lymphocyte. Also called regulatory T cell, suppressor T cell, and T-regulatory cell."|30 days post transplant|All participating recipients||ratio||Full Range|Median
23219|NCT01713348|Secondary|HbA1c||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle.||Percent||Standard Deviation|Mean
23220|NCT01713348|Secondary|HbA1c (mmol/Mol)||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.||mmol/mol||Standard Deviation|Mean
23221|NCT01713348|Secondary|Glucose Standard Deviation (SD)||Day 86 to 100 compared to day 1 to 15|||mmol/L||Standard Deviation|Mean
23222|NCT01713348|Secondary|Time in Range|Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.|Days 86 to 100 intervention arm compared to control arm|All analyses were performed according to the intention-to-treat principle.||hours per day||Standard Deviation|Mean
23223|NCT01713348|Primary|Time in Range|Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.|Day 86 to 100 compared to Day 1 to 15|All analyses were performed according to the intention-to-treat principle.||hours per day||Standard Deviation|Mean
23224|NCT01713283|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
23225|NCT01713283|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
23226|NCT01713283|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
23227|NCT01713283|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug||percentage of participants|||Number
23228|NCT01713283|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
23229|NCT01713036|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30+/-2 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|Part A and B: From the first dose of study drug administration until 30+/-2 days after the last dose of study drug administration, assessed up to 18 months|The safety analysis set included all subjects who received at least one administration of trial medication and have at least one subsequent safety assessment.||subjects|||Number
23230|NCT01713036|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)|Anti tumor activity defined as CR, PR, or stable disease and PD based on the investigator tumor evaluations performed every 2 cycles in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. CR =Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm); PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions; SD= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones.|From the screening every 2 cycles until end of the treatment, assessed up to 18 months|Safety analysis set included all subjects who received at least one administration of trial medication and had at least one subsequent safety assessment.||subjects|||Number
23231|NCT01713036|Secondary|Blood/ Plasma Concentration Ratios of Total [14C] Radioactivity||1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Ratio||Standard Deviation|Mean
23232|NCT01713036|Secondary|Fraction Unbound of [14C] Pimasertib|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration multiplied by 100.|1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||percentage of unbound drug||Standard Deviation|Mean
23233|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of M445 and M554||Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
23234|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of M445 and M554|The λz of M445 and M554 was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||per hour||95% Confidence Interval|Geometric Mean
23235|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M445 and M554|AUC from time 0 to infinity (AUC0-inf), was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/lambda z (λz). Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
23236|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) of M445 and M554|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
23237|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of M445 and M554|Time to reach maximum plasma concentration (Tmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
23272|NCT01712685|Secondary|Kinetic (Ki) Rate Constant|Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||1/Minutes||Standard Deviation|Mean
23238|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of M445 and M554|Maximum observed plasma concentration (Cmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Nanogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
23239|NCT01713036|Secondary|Apparent Volume of Distribution of Total [14C] Radioactivity During the Terminal Phase Following Oral Administration (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Vz/f of total radioactivity during the terminal phase was calculated by dividing the dose with the product of area under the plasma concentration time curve and apparent terminal rate constant (dose/AUC0inf*λz).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Liter||95% Confidence Interval|Geometric Mean
23240|NCT01713036|Secondary|Total Body Clearance of Total [14C] Radioactivity From Plasma Following Oral Administration (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed. Apparent body clearance of total radioactivity from plasma was calculated by dividing the dose with area under the plasma concentration time curve from zero to infinity (Dose/AUC0inf).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||liter per hour||95% Confidence Interval|Geometric Mean
23241|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
23242|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Total [14C] Radioactivity|λz of total [14C] radioactivity was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||per hour||95% Confidence Interval|Geometric Mean
23243|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Total [14C] Radioactivity|Area under the concentration time curve (AUC) from time zero to infinity (AUC0-inf) was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/λz. Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
23244|NCT01713036|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total [14C] Radioactivity|Area under the plasma concentration time curve from time zero to the last sampling time at which the concentration is at or above the lower limit of quantification was calculated by using mixed log linear trapezoidal rule. Unit of assessment was hour*nanogram equivalent per milliliter (hr*ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
23245|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour||Full Range|Median
23246|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity|Unit of assessment was nanogram equivalent per milliliter (ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||ng eq/mL||95% Confidence Interval|Geometric Mean
23268|NCT01712854|Secondary|Exercise Time in Steady State Exercise|Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.|||||
23247|NCT01713036|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Oral Administration (Vz/f) and the Apparent Volume of Distribution During the Terminal Phase Following Intravenous Administration (Vz) of [14C] Pimasertib|The apparent volume of distribution during the terminal phase following oral administration (Vz/f) and the apparent volume of distribution during the terminal phase following intravenous administration was calculated by using the formula=Dose/( AUC0-inf* λz).|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Liter||95% Confidence Interval|Geometric Mean
23248|NCT01713036|Secondary|The Volume of Distribution of the Central or Plasma Compartment (Vc) of Intravenous [14C] Pimasertib|The volume of distribution of the central or plasma compartment (Vc) was calculated using the formula=Dose/C0|Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||Liter||95% Confidence Interval|Geometric Mean
23249|NCT01713036|Secondary|Total Body Clearance of Unlabeled Pimasertib (CL/f) and Intravenous [14C] Pimasertib (CL)|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||liter per hour||95% Confidence Interval|Geometric Mean
23250|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib|Apparent terminal elimination rate constant (λz) was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||per hour||95% Confidence Interval|Geometric Mean
23251|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hours||Full Range|Median
23252|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Intravenous [14C] Pimasertib||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||picogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
23253|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Unlabeled Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||ng/mL||95% Confidence Interval|Geometric Mean
23254|NCT01713036|Primary|Number of Metabolites Identified Overall and as Major|Identification and profiling of the metabolites was done. The total number of metabolites and the number of metabolites identified as major were reported.|Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||metabolites|||Number
23255|NCT01713036|Primary|Plasma Concentrations of Pimasertib Metabolites|Plasma concentration of the Pimasertib metabolite M445 and M554 were presented for the outcome measure.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A. Here 'n' is the number of subjects analysed at each time point.||Nanogram equivalent per milliliter||Standard Deviation|Mean
23256|NCT01713036|Primary|Plasma Concentrations of [14C] Pimasertib||Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||nanogram equivalent per milliliter||Standard Deviation|Mean
23269|NCT01712854|Primary|The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).|Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.|||||
23257|NCT01713036|Primary|Mass Balance: Amount of Total Radioactivity Recovered Into the Urine and Feces From Time Zero to the Last Sampling Time Point (Ae0-t)|Recovery of total [14C]-radioactivity was determined in excreta, i.e., urine and feces at each sampling period subsequent to oral administration of [14C]-pimasertib on Day 8. Cumulative recovery of total [14C]-radioactivity in terms of percentage of dose recovered in urine and feces and total percentage of dose recovered was reported for the outcome measure.|Urine: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours post [14C]-labeled pimasertib dose on Day 8; Feces: 0-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||percentage of dose recovered||Full Range|Geometric Mean
23258|NCT01713036|Primary|Oral Bioavailability of Pimasertib After Single Oral Dose of Unlabeled Pimasertib and Intravenous (IV) Single Tracer Dose of [14C] Pimasertib|Oral bioavailability (F) was calculated using the formula=AUC0-inf oral/dose oral) / (AUC0-inf iv/dose iv) * 100%, where AUC0-inf is the area under the concentration time curve (AUC) from time zero to infinity.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with investigational medicinal product (IMP) intake for the complete Part A.||percentage bioavailability||90% Confidence Interval|Number
23259|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
23260|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of [14C]‐Pimasertib Following IV Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
23261|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
23262|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of [14C]‐Pimasertib Following Intravenous (IV) Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
23263|NCT01712984|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
23264|NCT01712984|Secondary|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.||Participants|||Number
23265|NCT01712984|Secondary|Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
23266|NCT01712984|Primary|Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).|Day 28 post-vaccination|Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.||Participants|||Number
23267|NCT01712984|Primary|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
23273|NCT01712685|Secondary|Time to Peak Activity Derived From Time Activity Curve (TAC)|The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Minutes||Standard Deviation|Mean
23274|NCT01712685|Secondary|Distribution Volume Ratio (DVR) for the Primary Kidney Lesions|DVR of the lesions was measured by the Logan graphical analysis method.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Distribution volume ratio||Standard Deviation|Mean
23275|NCT01712685|Secondary|Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene|Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories.|21 days prior to enrollment until closure of the study, approximately 14 months.|5/11 participants had germline VHL testing with 4 having identifiable mutations of the VHL gene. 6/11 participants did not have germline VHL mutation testing due to low index of clinical suspicion although 2/6 had germline analysis for other gene mutations linked to familial renal cell carcinoma conditions.||participants|||Number
23276|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Normal Kidney|Mean SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Standard uptake value (SUV||Full Range|Mean
23277|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC)|Mean SUV for primary clear cell renal carcinoma was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|Mean SUV for ccRCC after excluding Bosnial 3 Cyst (e.g. Bosnial 3 complex cyst) in one participant.||Standard uptake value (SUV||Full Range|Mean
23278|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for All Target Lesions|Mean SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|||Standard uptake value (SUV)||Full Range|Mean
23279|NCT01712685|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|58 days|||participants|||Number
23280|NCT01712685|Primary|Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)|"The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both non-tumor tissue."|58 days|||Standardized uptake value||Standard Error|Mean
23281|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
23282|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||number of puffs||Standard Error|Least Squares Mean
23283|NCT01712516|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
23284|NCT01712516|Secondary|Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, 12 weeks|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
23285|NCT01712516|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
23286|NCT01712516|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
23287|NCT01712516|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.||Liters||Standard Error|Least Squares Mean
23288|NCT01712516|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 – 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.||Liters||Standard Error|Least Squares Mean
23289|NCT01712516|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
23290|NCT01712516|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.||score on a scale||Standard Error|Least Squares Mean
23291|NCT01712516|Primary|Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.||Liters||Standard Error|Least Squares Mean
23292|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).~Efficacy variables to be analyzed:~- Subject satisfaction"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.||Percentage (%) of subjects|||Number
23293|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:~- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.~Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:~- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS)."|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
23294|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).~Efficacy variables to be analyzed:~Complete cure~Treatment effectiveness~Mycological cure~Clinical success~Clinical cure"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.||Percentage (%) of subjects (90% CI)||90% Confidence Interval|Number
23295|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:~- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.~Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:~- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state"|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
23296|NCT01712334|Primary|Safety: Number of Participants With Adverse Events During Each Treatment Period|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|4 Weeks|Safety population included all randomized participants who received treatment.||participants|||Number
23297|NCT01712334|Primary|Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed according to American Thoracic Society standards. FEV1 is the amount of air that is forced out of the lungs in one second and was measured at the end of each 2-week treatment period. The percent predicted FEV1 was calculated as: Percent predicted FEV1 =FEV1 (L) / Predicted FEV1 (L) ×100.|At the end of each 2-week treatment period|Modified Intent-to-Treat (mITT) population included all randomized participants with baseline and endpoint FEV1 values for both treatment periods.||percent predicted||Standard Deviation|Mean
23298|NCT01712204|Other Pre-specified|Mean Pain Visual Analog Scale Score Associated With Gout Flares||16 weeks||||||
23299|NCT01712204|Secondary|Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 or <5.0 mg/dL||16 weeks||||||
23300|NCT01712204|Secondary|Change From Baseline in Serum Uric Acid Concentration||16 weeks||||||
23301|NCT01712204|Secondary|Duration of Gout Flares||16 weeks||||||
23302|NCT01712204|Secondary|Gout Flare Days Per Subject||16 weeks||||||
23303|NCT01712204|Secondary|Time to First Gout Flare||16 weeks||||||
23304|NCT01712204|Secondary|Proportion of Subjects Experiencing ≥1 or ≥2 Gout Flares||16 weeks||||||
23305|NCT01712204|Primary|Number of Gout Flares Per Subject||16 weeks|||flares||95% Confidence Interval|Least Squares Mean
23306|NCT01712178|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing “no pain” and 100 representing “worst possible pain”. Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.|Immediately after injections on Day 1|||Millimeters||Standard Deviation|Mean
23307|NCT01712178|Secondary|Number of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.|From time of informed consent to 70 days following the last dose of study drug|||participants|||Number
23308|NCT01712178|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Measured through Week 24|||Percentage of participants|||Number
23309|NCT01712178|Secondary|Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24|The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Error|Least Squares Mean
23330|NCT01712061|Primary|Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline and Week 12|The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||percent (%)||95% Confidence Interval|Mean
23366|NCT01711216|Primary|Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.||participants|||Number
23310|NCT01712178|Secondary|Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Error|Least Squares Mean
23311|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||percentage of participants|||Number
23312|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||percentage of participants|||Number
23313|NCT01712178|Primary|Mean Disease Activity Scores (DAS28) at Weeks 12 and 24|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.||units on a scale||Standard Error|Least Squares Mean
23314|NCT01712178|Primary|Serum Concentrations of Adalimumab at Weeks 12 and 24|Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.|Measured at Weeks 12 and 24|Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.||µg/mL||Standard Deviation|Mean
23315|NCT01712061|Other Pre-specified|Number of Participants With Increased Fasting Blood Glucose||Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||participants|||Number
23316|NCT01712061|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.|Baseline up to 28 days after last study drug administration|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.||participants|||Number
23317|NCT01712061|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|Criteria for potentially clinically important ECG values were defined as: PR interval >=300 milliseconds (msec) or >=25%/50% increase when baseline is >200 msec and ≥50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); QTc >=450 msec or >=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline, Weeks 1, 4 and 12|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||participants|||Number
23343|NCT01711866|Secondary|Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit|"The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:~1 = Very much improved~2 = Much improved~3 = Minimally improved~4 = No change~5 = Minimally worse~6 = Much worse~7 = Very much worse."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 35.||participants|||Number
23318|NCT01712061|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).|Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.||participants|||Number
23319|NCT01712061|Other Pre-specified|Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||kilograms (kg)||Standard Deviation|Mean
23320|NCT01712061|Other Pre-specified|Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||beats per minute (bpm)||Standard Deviation|Mean
23321|NCT01712061|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.||millimeters of mercury (mm Hg)||Standard Deviation|Mean
23322|NCT01712061|Secondary|Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12||1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12|The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
23323|NCT01712061|Secondary|Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||percent||Standard Deviation|Mean
23324|NCT01712061|Secondary|Change From Baseline in Serum Cystatin C at Weeks 12 and 16|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mg/dL||Standard Deviation|Mean
23325|NCT01712061|Secondary|Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
23326|NCT01712061|Secondary|Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16|Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mL/min/1.73m^2||Standard Deviation|Mean
23327|NCT01712061|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mL/min/1.73m^2||Standard Deviation|Mean
23328|NCT01712061|Secondary|Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16|The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mg/mmolCr||Geometric Coefficient of Variation|Geometric Mean
23329|NCT01712061|Secondary|Change From Baseline in UACR at Weeks 4, 8 and 16|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.||mg/millimolar creatinine (mmolCr)||Geometric Coefficient of Variation|Geometric Mean
23797|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
23331|NCT01712009|Secondary|Number of Participants With Adverse Events (AEs)|"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.~The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies."|From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.|Safety analysis set included all participants who received primary prophylaxis with pegfilgrastim according to the prophylactic medication actually received. Participants in the Naproxen or Loratadine groups who did not receive naproxen or loratadine are analyzed in the No Prophylaxis group for safety analyses.||participants|||Number
23332|NCT01712009|Secondary|Area Under the Curve (AUC) for Patient-reported Bone Pain|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."||units on a scale * days||Standard Error|Least Squares Mean
23333|NCT01712009|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant’s bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."||units on a scale||Standard Error|Least Squares Mean
23334|NCT01712009|Secondary|Mean Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant’s bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."||units on a scale||Standard Error|Least Squares Mean
23335|NCT01712009|Secondary|Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles|Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."||percentage of participants||95% Confidence Interval|Number
23336|NCT01712009|Secondary|Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."||percentage of participants||95% Confidence Interval|Number
23337|NCT01712009|Primary|Percentage of Participants With Bone Pain (All Grades) in Cycle 1|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)|Full anlysis set||percentage of participants||95% Confidence Interval|Number
23338|NCT01711918|Secondary|Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
23339|NCT01711918|Secondary|Improvement of Abdominal Bloating or Distention Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
23340|NCT01711918|Secondary|Improvement of Vomiting Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
23341|NCT01711918|Secondary|Improvement of Nausea Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
23342|NCT01711918|Primary|Improvement of Overall Symptoms Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)|||Participants|||Count of Participants
23365|NCT01711216|Primary|Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.||participants|||Number
44963|NCT01387464|Primary|Mean Aqueous Humor Bromfenac Concentration||Approximately 3 hours post last dose|Per-Protocol Population||ng/mL||Standard Deviation|Mean
23344|NCT01711866|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:~0 = Side effects not assessable~1 = No side effects~2 = Side effects do not significantly interfere with subject’s functioning~3 = Side effects significantly interfere with the subject’s functioning~4 = Side effects outweigh therapeutic efficacy."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|All 87 subjects of the Safety Set are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.||participants|||Number
23345|NCT01711853|Primary|AUCtau,ss|"Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|PKS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
23346|NCT01711853|Primary|Cmax,ss|"Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
23347|NCT01711736|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23348|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23349|NCT01711736|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23350|NCT01711736|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23351|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23352|NCT01711736|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
23353|NCT01711736|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
23824|NCT01704495|Primary|Rate of Severe Asthma Exacerbations During 6 Months||From start of treatment up to 6 months|Full analysis set||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
23354|NCT01711736|Secondary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
23355|NCT01711736|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
23356|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23357|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).|Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23358|NCT01711736|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
23359|NCT01711736|Primary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
23360|NCT01711424|Secondary|Schirmer Score|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.||mm/5 min||Full Range|Median
23361|NCT01711424|Secondary|Tear Break Up Time (TBUT)|TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.||Seconds||Full Range|Median
23362|NCT01711424|Secondary|Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®|The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.||Participants|||Number
23363|NCT01711424|Primary|Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®|Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.||Participants|||Number
23364|NCT01711216|Secondary|Time to Relapse|The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.|Up to 6 months or longer after ended treatment|"Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.~Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (>85%) maintained regular cycles for the whole follow-up period"||percentage of subjects|||Number
48006|NCT01346397|Primary|Patient Survival|in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%|5 years|||percentage of participants||95% Confidence Interval|Number
23367|NCT01711216|Secondary|Change of Intensity of Anxiety|Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||units on a scale||Standard Deviation|Mean
23368|NCT01711216|Secondary|Change of Pain Intensity During Menstruation|Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||units on a scale||Standard Deviation|Mean
23369|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS.||days||Standard Deviation|Mean
23370|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS.||days||Standard Deviation|Mean
23371|NCT01711216|Secondary|Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||percentage of subjects|||Number
23372|NCT01711216|Secondary|Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 9 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.||percentage of subjects|||Number
23373|NCT01711216|Secondary|Overall Clinical Response on Treatment Assessed by Physician|Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.||participants|||Number
23374|NCT01711216|Secondary|Patient Satisfaction With the Treatment|Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.||participants|||Number
23375|NCT01711216|Secondary|Change of Intensity of Anxiety From Baseline to the End of Treatment|Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing.||units on a scale||Standard Deviation|Mean
23376|NCT01711216|Secondary|Change of Pain Intensity During Menstruation From Baseline to End of Treatment|Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing||units on a scale||Standard Deviation|Mean
23377|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS||days||Standard Deviation|Mean
23378|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea|Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS||days||Standard Deviation|Mean
23379|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS||days||Standard Deviation|Mean
23380|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea|Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS||days||Standard Deviation|Mean
23428|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||mg/L||Standard Deviation|Mean
23381|NCT01711216|Secondary|Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles|Up to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles||percentage of subjects|||Number
23382|NCT01711177|Primary|Blood Oxygenation|For each subject, all the measurements will be done during an 1 hour appointment.|1 hour|||percentage of oxygenation||95% Confidence Interval|Mean
23383|NCT01710800|Primary|Number of Impedance Episodes Following PPI and Placebo|Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.|1 week|We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.||number of episodes||Standard Deviation|Mean
23384|NCT01710657|Secondary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)|"Partial-onset seizure (POS) frequency per 28 days was calculated as:~POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.~A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period."|8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||Seizures per 28 days||Full Range|Median
23385|NCT01710657|Secondary|Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.|8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||percentage change||Full Range|Median
23386|NCT01710657|Secondary|The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)||8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||participants|||Number
23387|NCT01710657|Primary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|"Partial-onset seizure (POS) frequency per 28 days was calculated as:~POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.~A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period."|8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.||Seizures per 28 days||Full Range|Median
23388|NCT01710514|Secondary|Blood Progesterone Concentration||Weeks 2, 4, 5, 8, and end of study|FAS population||ng/mL||Standard Deviation|Mean
23389|NCT01710514|Secondary|Clinical Pregnancy Rate|Defined as presence of a gestational sac on transvaginal ultrasound|Week 4 of study|FAS with ET population||percentage of participants||95% Confidence Interval|Number
23390|NCT01710514|Secondary|Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG)||Week 2 of study|FAS with ET population In the TID group 13 subjects had a positive beta-hCG assessment while 14 subjects had a positive clinical pregnancy at Week 4. This is because one subject had a negative beta-hCG at Week 2, but she had a positive local serum hCG on the same day and continued the trial. Then clinical and ongoing pregnancy were confirmed.||percentage of participants||95% Confidence Interval|Number
23391|NCT01710514|Primary|Ongoing Pregnancy Rate|Defined as identification of fetal survival and fetal heart movements on transvaginal ultrasound|Week 5 of study|FAS with ET population||percentage of participants||95% Confidence Interval|Number
23392|NCT01710514|Primary|The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml||Day 5 of treatment|FAS population||percentage of subjects||95% Confidence Interval|Number
23393|NCT01710501|Secondary|Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response|Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.|From Day 1 up to Follow-up Week 24 (up to 48 weeks total)|Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.||participants|||Number
23394|NCT01710501|Secondary|Percentage of Subjects Achieving SVR24|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.|24 weeks after end of treatment (up to 48 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
23395|NCT01710501|Secondary|Percentage of Participants Achieving SVR4|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.|4 weeks after end of treatment (up to 28 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
23396|NCT01710501|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|From TW 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
23397|NCT01710501|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL.|From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
23398|NCT01710501|Primary|Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to 24 weeks|APaT Population; all randomized participants who received at least one dose of study treatment.||participants|||Number
23399|NCT01710501|Primary|Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|14 days following last dose of study drug (up to 26 weeks)|All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.||participants|||Number
23400|NCT01710501|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.|12 weeks after end of treatment (up to 36 weeks total)|Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.||percentage of participants||95% Confidence Interval|Number
23401|NCT01710345|Primary|SPID-12|"The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.~The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better."|12 hours|||units on a scale||Standard Error|Least Squares Mean
23402|NCT01710046|Secondary|Percent Change From Baseline in TPSS by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percent change from baseline||Standard Error|Mean
23403|NCT01710046|Secondary|Target Plaque Severity Score (TPSS) by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||score on a scale||Standard Error|Mean
23404|NCT01710046|Secondary|Change From Baseline in ISI by Visit|"ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement."|Weeks 1, 2, 4 and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
23427|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Baseline|The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23405|NCT01710046|Secondary|Itch Severity Item (ISI) Score by Visit|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15."|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
23406|NCT01710046|Secondary|Percent Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percent change from baseline||Standard Error|Mean
23407|NCT01710046|Secondary|Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.|||||
23408|NCT01710046|Secondary|Body Surface Area (BSA)|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||% BSA||Standard Error|Mean
23409|NCT01710046|Secondary|Percentage of Participants by PGA Response Category and Timepoint|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percentage of participants|||Number
23410|NCT01710046|Secondary|Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category||Baseline and Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.|||||
23411|NCT01710046|Secondary|Change From Baseline in PGA Score by Visit|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
23412|NCT01710046|Secondary|Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4|Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Weeks 1, 2, and 4|FAS||percentage of participants|||Number
23413|NCT01710046|Secondary|Percent Change From Baseline in PASI by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.||percent change from baseline||Standard Error|Mean
24282|NCT01696968|Secondary|T1 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T1 (one year after entry)|All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.||Participants|||Number
23414|NCT01710046|Secondary|Change From Baseline in PASI by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Weeks 1, 2, 4 and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.|||||
23415|NCT01710046|Secondary|Psoriasis Area and Severity Index (PASI) Score by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Baseline and Weeks 1, 2, 4, and 12|FAS; n (number) =number of participants with nonmissing observations at the specified visit.||units on a scale||Standard Error|Mean
23416|NCT01710046|Primary|"Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.|Week 12|FAS||percentage of participants|||Number
23417|NCT01710046|Primary|Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12|Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Week 12|FAS||percentage of participants|||Number
23418|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 57|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23419|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 29|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23420|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 15|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23421|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 8|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23422|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Baseline|The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23423|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 57|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23424|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 29|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23425|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 15|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23426|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 8|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23537|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
23429|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|Analysis population included all randomized participants who received at least 1 dose of study treatment.||mg/L||Standard Deviation|Mean
23430|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|Analysis population included all randomized participants who received at least 1 dose of study treatment.||mg/L||Standard Deviation|Mean
23431|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|Analysis population included all randomized participants who received at least 1 dose of study treatment.||mg/L||Standard Deviation|Mean
23432|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline|Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|Analysis population included all randomized participants who received at least 1 dose of study treatment.||Milligram per Liter (mg/L)||Standard Deviation|Mean
23433|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Standard Deviation|Mean
23434|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Standard Deviation|Mean
23435|NCT01710033|Primary|Accumulation Ratio (Rac) For CP-690,550|Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ratio||Standard Deviation|Mean
23436|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Full Range|Median
23437|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||hours||Full Range|Median
23438|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng/mL||Standard Deviation|Mean
23439|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
23440|NCT01710033|Primary|Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng*hr/mL||Standard Deviation|Mean
23441|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||ng*hr/mL||Standard Deviation|Mean
23442|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
23443|NCT01710020|Other Pre-specified|Dialyser Clearance (CL HD) From 3 to 3.5 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
24283|NCT01696968|Secondary|T0 (Baseline) CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T0 (at study entry)|All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.||Participants|||Number
23444|NCT01710020|Other Pre-specified|Overall Dialyser Clearance (CL HD)|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
23445|NCT01710020|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|2 hours post-dose in Period 1|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
23446|NCT01710020|Primary|Dialyser Clearance (CL HD) From 3 to 4 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
23447|NCT01710020|Primary|Dialyser Clearance (CL HD) From 2 to 3 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
23448|NCT01710020|Primary|Dialyser Clearance (CL HD) From 1 to 2 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
23449|NCT01710020|Primary|Dialyser Clearance (CL HD) From 0 to 1 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/min||Standard Deviation|Mean
23450|NCT01710020|Primary|Oral Clearance (CLpo)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||milliliter/minute (mL/min)||Standard Deviation|Mean
23451|NCT01710020|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||hr||Standard Deviation|Mean
23452|NCT01710020|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||hr||Full Range|Median
23453|NCT01710020|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
23454|NCT01710020|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.||ng*hr/mL||Standard Deviation|Mean
23455|NCT01710020|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1|Analysis set included all participants who received study medication.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
23456|NCT01709903|Secondary|Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment|Percentage of nights with 'no nighttime awakenings', percentage of days with 'no daytime symptoms', and percentage of 'days able to perform usual daily activities' over 26 weeks (FAS)|26 weeks|Full Analysis Set||% days in study||Standard Error|Least Squares Mean
23457|NCT01709903|Secondary|Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals|"The number of puffs of rescue medication taken in the previous 12 hours will be recorded in the Patient Diary in the morning and evening. Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point. Less puffs taken is better."|12 and 26 weeks|Full Analysis set||# of puffs||Standard Deviation|Mean
23458|NCT01709903|Secondary|Analysis of the TDI Focal Score Over the Whole Treatment Period|"The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. .Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point."|12 and 26 weeks|Full Analysis Set||Numbers on a scale||Standard Error|Least Squares Mean
23459|NCT01709903|Secondary|Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|26 weeks|Full Analysis set||numbers on a scale||Standard Error|Mean
23460|NCT01709903|Secondary|Analysis of Trough FVC (L) Over the Whole Treatment Period|Average of Trough Forced Vital Capacity (FVC) at 23 hours 15 min and the 23 hours 45 min post dose|12 and 26 weeks|Full Analysis Set||liter||Standard Error|Least Squares Mean
23461|NCT01709903|Secondary|Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period|Average of Trough Forced Expiratory Volume in one second (FEV1)|6,12,18 and 26 weeks|Full analysis set||liter||Standard Error|Least Squares Mean
23462|NCT01709903|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 1, 12 and 26 weeks|Full Analysis set||Liter||Standard Deviation|Mean
23463|NCT01709903|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Superiority of QVA 110/50μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d||26 weeks|FAS||liters||Standard Error|Least Squares Mean
23464|NCT01709903|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d|Measurement of QVA149 110/50 μg o.d. to fluticasone/salmeterol 500/50 μg b.i.d. in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.|26 weeks|FAS||liters||Standard Error|Least Squares Mean
23465|NCT01709864|Secondary|Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||liters||Standard Error|Least Squares Mean
23466|NCT01709864|Secondary|Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Vital Capacity (FVC) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||liters||Standard Error|Least Squares Mean
23467|NCT01709864|Secondary|Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||percentage of days||Standard Error|Least Squares Mean
23468|NCT01709864|Secondary|The Average Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the mean daily number of puffs used per patient over the 12 weeks treatment period.|baseline and 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||number of puffs||Standard Error|Least Squares Mean
23469|NCT01709864|Secondary|"Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization||pecentage of days||Standard Error|Least Squares Mean
23470|NCT01709864|Secondary|"Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours. The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization||percentage of days||Standard Error|Least Squares Mean
24343|NCT01695772|Secondary|Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12||Months 3, 6, 9, and 12|ITT population||PP of being alive and disease free||95% Confidence Interval|Median
23471|NCT01709864|Secondary|"Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. Percentage of no nighttime awakenings from Baseline up to 12 weeks."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization||percentage of nights||Standard Error|Least Squares Mean
23472|NCT01709864|Secondary|Change From Baseline of Morning and Nighttime Symptom Scores at Week 12|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am & each pm.Each question can be answered w/1 of 4 pre-defined answers,with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of the symptom scores(either the score assessed in am for the previous 12 hrs-referred to as nighttime scores,or the score assessed in pm for the previous 12 hrs-referred to as the daytime symptom score) for each patient over 12 weeks.The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only and included all randomized patients who received at least one dose of study drug.||score||Standard Error|Least Squares Mean
23473|NCT01709864|Secondary|Change From Baseline of Daily Symptom Scores|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am and each pm. Each question can be answered w/1 of 4 pre-defined answers, with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of combined daily symptom scores(combined from am & pm)for each patient over 12 weeks. The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. Patients may have met the min. response requirements for the night scores(am questions),but not for the day scores(pm questions)or vice versa, the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||Score||Standard Error|Least Squares Mean
23474|NCT01709864|Secondary|Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12|Breathlessness at week 12 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). Patients are considered to have clinically significant improvement with the TDI score change versus BDI being equal to or greater than 1. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||scores on a scale||Standard Error|Least Squares Mean
23475|NCT01709864|Secondary|Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12|The health status, as reported by the patients, is assessed using the St. George’s Respiratory Questionnaire (SGRQ). The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically significant improvement in SGRQ is defined as less than or equal to -4 change from baseline.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||percentage of participants|||Number
23476|NCT01709864|Secondary|Change From Baseline in the Health Status Assessed by St. George’s Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12||score||Standard Error|Least Squares Mean
23477|NCT01709864|Secondary|Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various time points post dosing on day 1 and at week 12 to calculate the AUC for these different time spans.|Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12||liters*hr||Standard Error|Least Squares Mean
23538|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
23478|NCT01709864|Secondary|Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit|Trough Forced Expiratory Volume in one second (FEV1) is the mean of FEV1 at 23h 15min and 23h 45min after the morning dose of the previous day. Pre-dose trough FEV1 is the mean of FEV1 at -45min and -15min before morning dose|Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||liters||Standard Error|Least Squares Mean
23479|NCT01709864|Primary|Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12||liters*hr||Standard Error|Least Squares Mean
23480|NCT01709799|Secondary|Timed Instrumental Activities of Daily Living Task|"The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
23481|NCT01709799|Primary|Sweep Seeker Subtest of PositScience Insight|"Participants watch two patterns that “sweep” in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
23482|NCT01709799|Primary|Road Tour Subtest of PositScience Insight|"Participants choose which car they saw at the center of the screen, and also locate where a Route 66 sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
23483|NCT01709799|Primary|Master Gardener Subtest of PositScience Insight|"Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
23484|NCT01709799|Primary|Jewel Diver Subtest of PositScience Insight|"Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
23485|NCT01709799|Primary|Bird Safari Subtest of PositScience Insight|"Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)|||T-score units||Standard Error|Mean
23486|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement|"When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.~For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.|||grams per deciliter||95% Confidence Interval|Mean
23487|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement|"Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.~For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.|||grams per deciliter||95% Confidence Interval|Mean
23488|NCT01709708|Secondary|Overall Satisfaction|Satisfaction scores Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B). Satisfaction scores are a likert scale ranging from 1 to 5 with 1 being complete dissatisfaction and 5 being complete satisfaction.|Estimated 10 Weeks||||||
23489|NCT01709708|Secondary|Headache Impact Test (HIT-6)|Headache Impact Test (HIT-6) scores Pre-Treatment at Visit 2 vs. Post-Treatment (following final treatment), and at 1-Month Post-Treatment (Group A vs. Group B). HIT-6 is a series of 6 likert scale questions ranging from 1 to 5 with 1 being never and 5 being always.|Estimated 10 Weeks||||||
23490|NCT01709708|Secondary|Adverse Events|Number of adverse events over the entire length of study (Group A vs. Group B).|Estimated 14 weeks||||||
23491|NCT01709708|Secondary|Acute Medications Usage|Number of acute medications used during Treatment period (estimated 6 weeks) and Follow-Up (estimated 4 weeks) (Group A vs. Group B).|Estimated 10 Weeks||||||
23492|NCT01709708|Secondary|Migraine Headache Days|Compare change in the number of migraine headache days per month reported in Baseline Period Diary vs. Treatment Period Diary vs. Post-Treatment Period Diary.|Estimated 14 Weeks||||||
23493|NCT01709708|Secondary|Modified Pain Characteristic Questionnaire|Compare Modified Pain Characteristic Questionnaire scores Before Procedure vs. 24-Hour After Procedure, Before Procedure vs. 1-Month Follow Up, and Before Procedure vs. 6-Month Follow Up (Group A vs. Group B). The modified pain characteristic questionnaire is a series of 11 questions on a likert scale ranging from 0 to 10 with 0 being no pain or does not interfere and 10 being worst pain or completely interferes.|6 Months||||||
23494|NCT01709708|Secondary|Patient's Global Impression of Change (PGIC)|Compare 24-Hour After Procedure Patient's Global Impression of Change (PGIC) score for 12 treatments (Group A vs. Group B). PGIC is a likert scale ranging from 1 to 7 with 1 being very much improved and 7 being very much worse.|Estimated 6 Weeks||||||
23495|NCT01709708|Secondary|Change in Numeric Rating Scale (NRS)|Compare change in Numeric Rating Scale (NRS) score from Before Procedure to 15-Minutes, Before Procedure to 30-Minutes, Before Procedure to 24-Hours After Procedure for all 12 treatments (Group A vs. Group B). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain.|Estimated 6 Weeks||||||
23496|NCT01709708|Primary|Numeric Rating Scale (NRS)|Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.|Estimated 6 Weeks|||units on a scale||Standard Deviation|Mean
23497|NCT01709513|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 24 Versus Atorvastatin - Raw Data Description - Intent-To-Treat (ITT) Analysis||From Baseline up to Week 24|ITT population||percent change||Standard Deviation|Mean
23498|NCT01709513|Other Pre-specified|Percentage of Participants Who Experienced Skeletal Muscle-related Adverse Event (AE)|Skeletal muscle-related adverse events were a predefined category including myalgia, muscle spasms, muscular weakness, musculoskeletal stiffness and muscle fatigue. Events that developed during treatment emergent adverse events period (the time from the first double-blindstudy treatment [injection or capsules, whichever came first] up to the day of the last double-blind injection + 70 days ) are reported.|From Baseline up to Week 24|Safety population||participants|||Number
23499|NCT01709513|Secondary|Percent Change From Baseline in Apo A­-1 at Week 12 -­ ITT Analysis|Least squares (LS) means and standard errors (SE) taken from MMRM (mixed effect model with repeated measures) analysis.|From Baseline to Week 12|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
23500|NCT01709513|Secondary|Percent Change in Fasting Triglycerides From Baseline to Week 12 -­ ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Fasting Triglycerides ITT population.||percent change||Standard Error|Mean
23501|NCT01709513|Secondary|Percent Change in HDL-C From Baseline to Week 12 -­ ITT Analysis|Least-squares (LS) means and standard errors (SE) taken from MMRM (mixed-effect model with repeated measures) analysis|From Baseline to Week 12|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
23502|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 -­ ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Lipoprotein(a) ITT population.||percent change||Standard Error|Mean
23503|NCT01709513|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23504|NCT01709513|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population||percent change||Standard Error|Mean
23505|NCT01709513|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23506|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
23507|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
23508|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
23509|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.||percentage of participants|||Number
23510|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.||percentage of participants|||Number
23511|NCT01709513|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
23512|NCT01709513|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
23513|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 12 -­ ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
23514|NCT01709513|Secondary|Percent Change From Baseline in Total Cholesterol (Total­-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23515|NCT01709513|Secondary|Percent Change From Baseline in Non­-HDL-C at Week 24 ­- On­-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
23516|NCT01709513|Secondary|Percent Change From Baseline in Non­-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 ­- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23517|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 24 -­ On-­Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.||percent change||Standard Error|Least Squares Mean
23518|NCT01709513|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 ­- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-­baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23519|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On­-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 12|mITT population.||percent change||Standard Error|Least Squares Mean
23520|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL­-C at Week 12 -­ ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|ITT population.||percent change||Standard Error|Least Squares Mean
48293|NCT01342471|Primary|Physical Activity (Steps/Day)|Change in pedometer measured steps per day between 0 and 6 months|0 and 6 months|||steps/day||Standard Deviation|Mean
23521|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-­Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
23522|NCT01709513|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-­To-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
23523|NCT01709500|Secondary|Percent Change From Baseline in Apo A­1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
23524|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Fasting triglycerides ITT population.||percent change||Standard Error|Mean
23525|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
23526|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Lipoprotein (a) ITT population.||percent change||Standard Deviation|Mean
23527|NCT01709500|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23528|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
23529|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23530|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.||percent change||Standard Error|Mean
23531|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis|Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to Week 52|mITT population.||percentage of participants|||Number
23532|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.||percentage of participants|||Number
23533|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to week 52|mITT population.||percentage of participants|||Number
23534|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.||percentage of participants|||Number
23535|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off treatment (ITT analysis).|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
23536|NCT01709500|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment.|From Baseline to Week 52|Total-­C ITT population.||percent change||Standard Error|Least Squares Mean
23539|NCT01709500|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23540|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population||percent change||Standard Error|Least Squares Mean
23541|NCT01709500|Secondary|Percent Change From Baseline in Non-High ­Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23542|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on­treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population||percent change||Standard Error|Least Squares Mean
23543|NCT01709500|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23544|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
23545|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
23546|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
23547|NCT01709500|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent­-to­-Treat (ITT) Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least­ squares (LS) means and standard errors at Week 24 were obtained from a mixed ­effect model with repeated measures (MMRM) to account for missing data. All available post ­baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model.|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
23548|NCT01709474|Primary|Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3|Adverse event grading based on National Cancer Institute— Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0|Baseline to 18 Weeks|Intent-to-treat||Percentage of Participants|||Number
23549|NCT01709474|Primary|Change in Average IFN Module Expression Level|No mechanistic analyses were performed due to recruitment feasibility issues.|Baseline to Week 18|Data were not collected and therefore no analyses could be performed.|||||
23550|NCT01709422|Primary|Procedure Related Time|(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.|participants will be followed for the duration of procedure, an expected average of 2.0 hours ]|Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).||minutes||Standard Deviation|Mean
23551|NCT01709422|Secondary|Cardiovascular Adverse Events.|(1) desaturation(oxygen saturation < 90 % at least 10 second ) (2) hypotension ( systolic blood pressure < 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate < 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation < 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.|participants will be followed for the duration of procedure, an expected average of 2.0 hours|Intention to treat population include participants who received sedative agents and underwent ERCP.||Participants|||Number
23552|NCT01709331|Secondary|Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52|Semen samples were produced by masturbation after at least 48 hours of sexual abstinence and collected for evaluation in the pretreatment phase at Week -1, and during the combined treatment phase at Weeks 16, 28, 40, and 52.|Up to Week 52|FAS population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.||Percentage of participants||95% Confidence Interval|Number
23579|NCT01708954|Secondary|Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher||Assessed every 4 weeks while on treatment and for 30 days after the end of treatment|All patients who received protocol therapy||Proportion of participants||90% Confidence Interval|Number
23553|NCT01709331|Primary|Percentage of Participants With Anti-Corifollitropin Alfa Antibodies|Blood samples were collected for assessment of anti-corifollitropin alfa antibodies in the pretreatment phase at Week -16 and Week -1; during the combined treatment phase at Weeks 4, 16, 28, 50, 52; and at the post-treatment follow-up visit, which could occur from Week 53 up to Week 57.|Up to Week 57|All-Subjects-as-Treated (ASaT) population, which consisted of all participants who received any dose of corifollitropin alfa.||Percentage of participants|||Number
23554|NCT01709331|Primary|Change From Baseline in Log-Transformed Testicular Volume at Week 52|Participants underwent testicular ultrasound in the pretreatment phase at Weeks -16, -8, -1; and during the combined treatment phase at Baseline (predose, Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The testicular volume was measured as the sum of volumes of left and right testes. The mean change from Day 1 in log-transformed testicular volume was analyzed using a mixed model with a fixed effect for time point and a random effect for the participant. For each time point, the mean change from Day 1 to that time point and the associated 95% confidence interval (CI) was calculated. The geometric mean fold change in testicular volume and its 95% CI was obtained by exponentiation.|Baseline and Week 52|Full Analysis Set (FAS) population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.||Fold change||95% Confidence Interval|Geometric Mean
23555|NCT01709305|Secondary|Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)|"The percentage of participants with a GI AE of abdominal pain was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
23556|NCT01709305|Secondary|Percentage of Participants With a GI AE of Diarrhea (Phase 2)|"The percentage of participants with a GI AE of diarrhea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
23557|NCT01709305|Secondary|Percentage of Participants With a GI AE of Vomiting (Phase 2)|"The percentage of participants with a GI AE of vomiting was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
23558|NCT01709305|Secondary|Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)|"The percentage of participants with a GI AE of nausea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
23559|NCT01709305|Secondary|Percentage of Participants With Hypoglycemia Events (Phase 2)|Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||Percentage of Participants|||Number
23560|NCT01709305|Secondary|Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)|Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.|Phase 2 Baseline (Week 20), Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.||kg||Standard Deviation|Mean
23561|NCT01709305|Primary|Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)|HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.|Phase 2 Baseline (Week 20) and Week 44|Per-Protocol (PP) population - excluded those participants who were identified as protocol violators and those who were non-compliant with Good Clinical Practice (GCP) requirements.||Percent||95% Confidence Interval|Least Squares Mean
23562|NCT01709162|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 of treatment to 90 days after last dose (or to death date for death information)|All participants who received at least 1 dose of study drug||Participants|||Number
23563|NCT01709162|Secondary|Best Overall Response Rate (BORR)|BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized|||||
23564|NCT01709162|Secondary|Disease Control Rate (DCR)|DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized|||||
23565|NCT01709162|Primary|Overall Survival|Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)|From randomization to death or last known alive date, assessed up to 15.6 months|All participants who were randomized||Months||Full Range|Median
23566|NCT01709136|Secondary|SRL Prevent TAC-related Side Effects|Whether SRL can prevent or minimize progression of selected TAC-related side-effects such as renal dysfunction as measured by clearance of iothalamate (Glomerular filtration rate < 80 mL/min/1.73 m2) and hypertension (blood pressure > 140/90 mm Hg)|1 year|Due to FDA blackbox warnings from FDA (6/11/2009) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.|||||
23567|NCT01709136|Primary|Early and Late Pharmacokinetics of Sirolimus (SRL)|To evaluate early and late pharmacokinetics of Sirolimus (SRL) , and safety and efficacy of conversion from tacrolimus (TAC) to sirolimus in liver transplant recipients who have been stable for at least 3 months, and who have early nephrotoxicity and/or hypertension due to use of tacrolimus.|1 year|Three pharmacokinetics (PK) profiles were performed, one in each of three patients who were enrolled. However, due to FDA blackbox warnings (6/11/2009) about Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.|||||
23568|NCT01709136|Secondary|SRL Can Substitute TAC|Whether Sirolimus can substitute Tacrolimus in the stable post-transplant state, without compromising allograft function|12 months|Due to FDA blackbox warnings (6/11/09) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early. Due to the early termination of this study and small number of subjects enrolled (3), data analysis was not able to be completed.|||||
23569|NCT01709136|Secondary|PK Parameters for Tacrolimus and Sirolimus|pharmacokinetics (PK) of SRL after a single dose and after steady state has been achieved; and the pharmacokinetics of tacrolimus once at steady state|12 months|We were able to preform 3 pharmacokinetics (PK) profiles, one in each of three patients enrolled. However, due to emerging data and blackbox warnings from FDA suggesting that use of Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.|||||
23570|NCT01709084|Secondary|Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations|To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.|Up to Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.||Participants|||Number
23571|NCT01709084|Secondary|Percentage of Participant With Treatment Adherence Based on Tablet Count|In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively).|Up to 48 Weeks|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
23572|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
23573|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
23574|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48|Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.||Percentage of Participants|||Number
23575|NCT01709084|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus – Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48|Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.||Percentage of Participants|||Number
23576|NCT01708967|Primary|Success Rate of Transnasal Endoscopy|"We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.~We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity."|During transnasal endoscopy, up to 1 hours|||percentage of Participants||95% Confidence Interval|Number
23577|NCT01708967|Other Pre-specified|Satisfaction|Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.|after transnasal endoscopy||||||
23578|NCT01708967|Secondary|Vital Signs|Blood pressure, heart rate, and O2 saturation were assessed.|before, during, and after transnasal endoscopy||||||
23580|NCT01708954|Secondary|Proportion of Patients With MET Positivity|Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women’s Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.|Assessed at baseline|Eligible and treated patients who had sufficient samples for MET expression analysis.||proportion of participants||95% Confidence Interval|Number
23581|NCT01708954|Secondary|Proportion of Patients With Objective Response|Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients||proportion of participants||95% Confidence Interval|Number
23582|NCT01708954|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
23583|NCT01708954|Primary|Progression-free Survival (PFS)|PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
23584|NCT01708915|Secondary|Patient Assessment of Efficacy on the Last Individual Treatment Day|Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application|1 to 4 days|Patients from FAS.||participants|||Number
23585|NCT01708915|Secondary|Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day|Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 1 to 4 days|Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day.||units on a scale||Standard Error|Least Squares Mean
23586|NCT01708915|Secondary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 4 hours after first ointment application|Patients from FAS.||units on a scale||Standard Error|Least Squares Mean
23587|NCT01708915|Primary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application|Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 8 hours after first ointment application|Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first application.||units on a scale||Standard Error|Least Squares Mean
23588|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.|From baseline until week 12|FAS||percentage of participants||95% Confidence Interval|Number
23589|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group|"The frequency of patients with use of rescue therapy during 24 week treatment period in main group.~For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group."|From baseline until week 24|FAS||percentage of participants||95% Confidence Interval|Number
23590|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG|"The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.~Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 12|FAS (LOCF)||mg/dL||Standard Error|Mean
23591|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group|"The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.~Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 24|FAS (LOCF)||mg/dL||Standard Error|Mean
23592|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in APG|The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG|From baseline until week 12|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
23593|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in Main Group|The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group|From baseline until week 24|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
23594|NCT01708902|Primary|The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG|"The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)~The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 12|FAS (LOCF)||percentage||Standard Error|Mean
23595|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)|"The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.~The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.~The sensitivity analysis was added as the primary analysis failed with borderline results."|Baseline and week 24|FAS (OC): subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered||percentage||Standard Error|Mean
23596|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
23597|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
23598|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)||percentage of participants||95% Confidence Interval|Number
23599|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS - non-completers were considered as nonresponders (NCF)||percentage of participants||95% Confidence Interval|Number
23600|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group|"The change from baseline in HbA1c after 24 weeks of treatment in main group.~The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 24|Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.||percentage||Standard Error|Mean
23601|NCT01708525|Primary|Rate of Collagen Synthesis|Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.|4 weeks post-treatment|||percentage of new collagen synthesized|||Number
23602|NCT01708317|Primary|Gonorrhea and Chlamydia Testing in the Pediatric ED|"The primary outcome was change in the proportion of adolescent patients receiving chlamydia and gonorrhea testing rates during their ED visit over 4 time periods.~Period 1) 2010 testing as a historical control Period 2) Jan 2011, began providing staff education about the risks of gonorrhea/chlamydia and need for increased testing Period 3) Education continues, but enrolled patients in the ACASI from April 18, 2011 - Dec 20, 2011.~Period 4) ACASI enrollment completed, education continued through March 2012~We specifically analyzed gonorrhea/chlamydia testing among ED patients that would have been eligible to take the ACASI, had it been continuously available throughout these time periods. We did this to isolate the effects on testing by the ACASI vs. education alone."|27 months|We analyzed every patient in this time period that met our ACASI inclusion/exclusion criteria||percentage of participants|||Number
23603|NCT01708291|Primary|Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)|Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in <5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score >= 7 indicates stress.|Baseline and week 10|||participants|||Number
23604|NCT01708278|Primary|Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description|"Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function.~PULMONARY FUNCTION TEST:~FEV1% of predicted: decline by >20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : <2000, Platelets (cells)/mm3: <25,000, Hemoglobin (g/dL): <7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): <125 or >148, Potassium (mmol/L): < 3.0 or > 6.0, Calcium (mmol/L): <7.4 or > 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value >3X upper limit of normal"|One week in Phase I safety study|||Participants|||Count of Participants
23605|NCT01708213|Secondary|Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS|This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.|6 months|||percentage of participants|||Number
23606|NCT01708213|Secondary|Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds|"For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).~WSS:~(0) - No wrinkle~- Just perceptible wrinkle~- Shallow wrinkle~- Moderately deep wrinkle~- Deep wrinkle, well-defined edges~- Very deep wrinkle, redundant fold"|6 months|Wrinkle Severity Score (WSS) assessment values of the Nasolabial Folds treatment area for the Per Protocol population (N=10) is a subgroup of the N=43 per protocol subjects treated. Reporting on the subjects with a 1 point improvement on the WSS at 6 months time.||participants|||Number
23607|NCT01708213|Primary|Assessment of Treatment Site Responses Post Procedure|The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.|6 months|||percentage of participants with any AE|||Number
23608|NCT01708187|Primary|Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months|"Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.~VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score"|Baseline,12 months|||units on a scale|||Number
23609|NCT01708122|Secondary|O2 Saturation Post Drug Administration|After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.|Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.|||percentage of O2 Saturation||Full Range|Mean
23610|NCT01708122|Primary|Pre Procedure 0 - 10 Pain Numerical Rating Scale|"The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:~1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed."|Pre procedure, During procedure, Post procedure|||0 - 10 Pain Numerical Rating Scale||Full Range|Median
23611|NCT01708057|Secondary|PK Parameters (AZD8683)|Cmax, tmax, AUC|Pre-dose, 24hr post-dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
23612|NCT01708057|Secondary|Maximum Increase in QTcF|maximum (post-dose values – baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
23613|NCT01708057|Secondary|Maximum Increase Heart Rate [HR]|Maximum (post-dose values – baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
23614|NCT01708057|Secondary|Maximum Increase in Diastolic Blood Pressure [DBP]|Maximum (post-dose values – baseline value) for each treatment visit.|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
23615|NCT01708057|Secondary|Maximum Increase in Systolic Blood Pressure [SBP]|Maximum (post-dose values - baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.|||||
23616|NCT01708057|Secondary|Average FEV1 as a Change From Baseline|Average FEV1 (0-24h): The average over 0 to 24 hours|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.|||||
23617|NCT01708057|Primary|Change From Baseline in Trough FEV1 (22-26h)|The average over 22 to 26 hours, as change from baseline|22 to 26 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.|||||
23618|NCT01708057|Primary|Change From Baseline in Peak FEV1 (0-24h)|The maximum value over 24 hours post-dose, as change from baseline|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have been analysed.|||||
23619|NCT01707667|Secondary|Motility Index|Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||mmHg||Standard Error|Least Squares Mean
23620|NCT01707667|Secondary|Duration of HAPC|The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||sec||Standard Error|Least Squares Mean
23621|NCT01707667|Secondary|Propagation Velocity of HAPC|Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||cm/sec||Standard Error|Least Squares Mean
23622|NCT01707667|Secondary|Time to First HAPC|The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.|over 12 hours post-dose|The Pharmacodynamic Analysis Set included all subjects in the Safety Analysis Set who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||hours||95% Confidence Interval|Median
23623|NCT01707667|Secondary|The Mean Amplitude of HAPC|The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||mmHg||Standard Error|Least Squares Mean
23624|NCT01707667|Secondary|Area Under the Concentration Curve (AUC) of All HAPCs|The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||mmHg.sec||Standard Error|Least Squares Mean
23625|NCT01707667|Primary|The Number of High-Amplitude Propagating Contractions (HAPC)|Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.||Number of HAPC with amplitude ≥100mmHg||Standard Error|Least Squares Mean
23626|NCT01707654|Other Pre-specified|Pain|Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1–3 cm), moderate (4–6 cm) and severe (7–10 cm).|17–25 months||||||
23627|NCT01707654|Secondary|Semmes-Weinstein (SW) Monofilament Test|The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.|17–25 months||||||
23628|NCT01707654|Primary|2-point Discrimination Test|The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.|17-25 months|||mm||Standard Deviation|Mean
23629|NCT01707238|Secondary|Satisfaction With Comfort|Participant’s subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit|||percentage of participants|||Number
23630|NCT01707238|Secondary|Satisfaction With Dryness|Participant’s subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit|||percentage of participants|||Number
23631|NCT01707238|Primary|Satisfaction With Handling|Participant’s subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit|||percentage of participants|||Number
23632|NCT01707238|Secondary|Dryness|Participant’s subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).|two weeks and four weeks from baseline visit|||units on a scale||Standard Deviation|Mean
23633|NCT01707238|Secondary|Comfort|Participant’s subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).|two weeks and four weeks from baseline visit|||units on a scale||Standard Deviation|Mean
23634|NCT01707238|Primary|Handling|Participant’s subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).|two weeks and four weeks from baseline visit|||units on a scale||Standard Deviation|Mean
23635|NCT01707225|Secondary|Need for Blood Transfusion and Hospital Admission for GI Bleed||24 weeks|||participants||95% Confidence Interval|Number
23636|NCT01707225|Primary|Number of Participants With Side-Effects|"Cardiovascular:~Sinus bradycardia (19% to 25%) Hypertension (≤13%) conduction abnormalities (9% to 10%)~Central nervous system:~Fatigue (1% to 32%) headache (6% to 30%) malaise (16% to 20%) fever (16% to 20%) dizziness (5% to 20%) Pain (4% to 15%)~Dermatologic:~Pruritus (≤18%) Rash (15%; depot formulation) alopecia (≤13%)~Endocrine & metabolic:~Hyperglycemia (2% to 27%)~Gastrointestinal:~Abdominal pain (5% to 61%) loose stools (5% to 61%) nausea (5% to 61%) diarrhea (34% to 58%) flatulence (≤38%) cholelithiasis (13% to 38%; length of therapy dependent) constipation (9% to 21%) vomiting (4% to 21%)~Hematologic Anemia (5-15%)~Local:~Injection site pain (2% to 50%; dose and formulation related)~Neuromuscular & skeletal:~Back pain (1% to 27%) arthropathy (8% to 19%) myalgia (≤18%)~Renal Kidney Stones (5-15%)~Respiratory:~Upper respiratory infection (10% to 23%)~Miscellaneous:~flu symptoms (1% to 20%)"|24 weeks|||participants||95% Confidence Interval|Number
23637|NCT01707095|Secondary|Histologic Evidence of Burn at the Epigastric Port Site Skin.|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day|||participants|||Number
23638|NCT01707095|Primary|Histologic Thermal Injury to Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.|1 day|||participants|||Number
23639|NCT01706926|Secondary|Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.||percentage of participants|||Number
23640|NCT01706926|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each arm, respectively."||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
23674|NCT01706666|Primary|Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months|Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.|24 months|||percentage of participants|||Number
23641|NCT01706926|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169|FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
23642|NCT01706926|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23643|NCT01706926|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23644|NCT01706926|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23645|NCT01706926|Secondary|Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."||ratio||Geometric Coefficient of Variation|Geometric Mean
23646|NCT01706926|Secondary|Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169|CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."||ratio||Geometric Coefficient of Variation|Geometric Mean
23647|NCT01706926|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
23648|NCT01706926|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||cm||Standard Error|Mean
23649|NCT01706926|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||mm||Standard Error|Mean
23650|NCT01706926|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||mm||Standard Error|Mean
23675|NCT01706588|Secondary|Number of Patients With Adverse Events||from signature of the informed consent to 1 week postsurgery||||||
23676|NCT01706588|Secondary|Vital Signs||presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.||||||
23651|NCT01706926|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||joint count||Standard Error|Mean
23652|NCT01706926|Secondary|Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23653|NCT01706926|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23654|NCT01706926|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Error|Mean
23655|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23656|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23657|NCT01706926|Secondary|Oxygen Saturation Level at Day 169|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||percent saturation||Standard Deviation|Mean
23658|NCT01706926|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
23659|NCT01706926|Secondary|Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15 percent (%), more than (>) 15 to =<20%, and >20%.|Day 169|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."||percent of pulmonary test values|||Number
23660|NCT01706926|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.||participants|||Number
23677|NCT01706588|Secondary|Recurrent Bleeding||every hour up to 6 hour postsurgery||||||
23678|NCT01706588|Secondary|Wound Healing||at 6 hour postsurgery, and on day 3 and 1 week postsurgery||||||
23679|NCT01706588|Secondary|Time to Onset of Pain||measured from end of surgery up to 12 hours postsurgery||||||
23661|NCT01706926|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.||participants|||Number
23662|NCT01706926|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.||percentage of participants|||Number
23663|NCT01706926|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.||percentage of participants|||Number
23664|NCT01706926|Primary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Baseline and Day 85|"The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
23665|NCT01706822|Secondary|Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate|Operatively|||% of cases surgeon agree/strongly agree|||Number
23666|NCT01706822|Secondary|Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|2. Visibility measured by surgeon usability questionnaire|Operatively|||% of cases surgeon agree/strongly agree|||Number
23667|NCT01706822|Secondary|Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|1. Access measured by surgeon usability questionnaire.|Operatively|||% of cases surgeon agree/strongly agree|||Number
23668|NCT01706822|Primary|The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative|||participants|||Number
23669|NCT01706822|Primary|The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The surgeon’s ability to achieve a staple line at the desired level of the rectum.|Operative|||participants|||Number
23670|NCT01706770|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.~The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit."|Any occurrence from baseline to 1 month visit|Unique eyes are defined as each individual eye in the study.||number of adverse events|Participants||Number
23671|NCT01706770|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.~The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.||units on a scale|Participants|Full Range|Mean
23672|NCT01706666|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.|From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years|||Months to Progression|||Number
23673|NCT01706666|Secondary|Survival Time|The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All patients are still alive||Months to death|||Number
23680|NCT01706588|Secondary|Patient and Investigator Global Evaluation of the Effectiveness of Treatment||at 6 hour postsurgery and on Day 3||||||
23687|NCT01706588|Primary|Area Under the Curve (AUC) of the Pain Scores.|Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery|||mm*minutes||Standard Deviation|Mean
23688|NCT01706575|Secondary|Safety: Number of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 48|Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.||participants|||Number
23689|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels||Baseline and Week 48||||||
23690|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes||Baseline and Week 48||||||
23691|NCT01706575|Secondary|Efficacy: Percentage of Participants With Serum HBsAg Loss at Week 48, 72 and 96|HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.|Week 48, 72 and 96||||||
23692|NCT01706575|Secondary|Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48||Baseline and Week 48||||||
23693|NCT01706575|Secondary|Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96||Baseline, Week 24, 72 and 96||||||
23694|NCT01706575|Primary|Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)|Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.|Baseline and Week 48|ITT population included all participants who received at least one dose of study drug. Here number of participant analyzed is total number of participants who were evaluable for this outcome measure. The Last Observation Carried Forward (LOCF) approach was applied to lost-to-follow-up participants without efficacy measurement at week 48.||percentage of participants|||Number
23695|NCT01706575|Primary|Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)||Baseline up to Week 48|Intent to Treat (ITT) population included all participants who received at least one dose of study drug. Here number of participant analyzed is total number of participants who were evaluable for this outcome measure.||percent change||Standard Deviation|Mean
23696|NCT01706549|Secondary|Is the Pain Due to Hysterectomy?|Number of patients having posthysterectomy pain versus other pain|1-3 years|||participants|||Number
23697|NCT01706549|Secondary|Quality of Life After Hysterectomy|Quality of life as measured by the SF-36, which consists of 8 scales.|1-3 years after hysterectomy||||||
23698|NCT01706549|Primary|Type of Chronic Pain After Hysterectomy|Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.|1-3 years after hysterectomy|Women undergone hysterectomy previously and reported having pain at the site of surgery six months after surgery||participants|||Number
23699|NCT01706328|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline trough was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 85|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
23700|NCT01706328|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1 during the 0- to 4-hour serial measurements (5, 15, 30, 60, 120, and 240 minutes post-dose). Participants who never met or exceeded a 100 mL increase over the Baseline value during the 4-hour serial measurements were censored at the actual time of their last FEV1 measurement.|Baseline and Day 1|ITT Population. Only those participants available at the indicated time point were assessed.||Minutes||Full Range|Median
23701|NCT01706328|Primary|Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating the area under curve, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measurements on Day 84 minus the Baseline trough FEV1 value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study drug. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
23702|NCT01706159|Secondary|Maximum Concentration (Cmax) of rFXIII|The peak plasma concentration of the drug after dose administration.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose PK for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.|||||
23703|NCT01706159|Secondary|Clearance (CL) of rFXIII|The volume of plasma cleared of the drug per unit time.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose pharmakokinetics (PK) for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.|||||
23704|NCT01706159|Secondary|Number of Adverse Events (AEs)|Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.|Week 0 to 10|Safety analysis set included all randomised and treated subjects.||events|||Number
23705|NCT01706159|Secondary|Remission (Clinical and Endoscopic)|Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).|At Week 8|Full analysis set (FAS) included all randomised and treated subjects. Two subjects in the rFXIII group had no UC-DAI score at any visit, including baseline and they were excluded from the analysis.||Subjects|||Number
23706|NCT01706159|Primary|Endoscopic Remission Defined as a Modified Baron Score of 0|"The primary endpoint was the binary variable (responder vs. non-responder) where responders were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as “non-responders”."|At week 8|Full analysis set (FAS) included all randomised and treated subjects.||Subjects|||Number
23707|NCT01706146|Other Pre-specified|Stroke-free Survival Rate|To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
23708|NCT01706146|Other Pre-specified|Major Bleeding-free Survival Rate|To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
23709|NCT01706146|Other Pre-specified|Overall Survival|To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
23710|NCT01706146|Other Pre-specified|Stroke Rate|To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.|12 months||||||
23711|NCT01706146|Secondary|Bleeding Incidence|To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.|up to 12 months|||participants|||Number
23712|NCT01706146|Primary|Number of Days on Anticoagulation|Assess subject anticoagulant utilization and number of days on anticoagulation|up to 12 months|||days||Standard Deviation|Mean
23713|NCT01705717|Secondary|Percentage of Participants Who Died|Any cause of death (including non-liver disease related) was reported.|Diagnosis and End of Study, up to 36 months after diagnosis|All enrolled participants||percentage of participants|||Number
23714|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants||percentage of participants|||Number
23715|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Cirrhosis||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants||percentage of participants|||Number
23716|NCT01705717|Secondary|Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion|HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.|End of Study, up to 36 months after diagnosis.|All enrolled participants;||percentage of participants|||Number
23717|NCT01705717|Secondary|Percentage of Participants Who Were HCV Seronegative at the End of Treatment|End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.|End of Study, up to 36 months after diagnosis.|All enrolled participants||percentage of participants|||Number
23718|NCT01705717|Primary|Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy|SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.|6 months|All enrolled participants.||percentage of participants|||Number
23719|NCT01705652|Primary|PSA (Prostate Specific Antigen)|PSA decline to < 1.0 ng/ml at 3 months post end of radiation or surgery|3 months post end of radiation treatment or surgery|Radiation Group: One subject who did not complete the study was included as he did stay in the study through the 3 month post radiation treatment time period, and dropped out after that time.||participants|||Number
23720|NCT01705574|Secondary|Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase||Baseline; Open-Label Extension Week 48||||||
23721|NCT01705574|Secondary|Percentage of Participants Receiving E/C/F/TDF or ATV+RTV+FTC/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase||Open-Label Extension Week 48||||||
23722|NCT01705574|Secondary|Percentage of Participants Receiving Open-Label E/C/F/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open- Label Extension Phase|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Open-Label Extension Week 48||||||
23723|NCT01705574|Secondary|Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase||Baseline; Week 48|Participants in the ITT Analysis Set with available data were analyzed.||cells/μL||Standard Deviation|Mean
23724|NCT01705574|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
23725|NCT01705496|Other Pre-specified|Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject’s infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.~The trial failed primary outcome, and this secondary outcome was not analyzed."|30 hours||||||
23726|NCT01705496|Other Pre-specified|Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.~The trial failed primary outcome, and this secondary outcome was not analyzed."|15 mins||||||
23798|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
23799|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
23727|NCT01705496|Other Pre-specified|Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards|"An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.~The trial failed primary outcome, and this secondary outcome was not analyzed."|30 +/- 2 days||||||
23728|NCT01705496|Secondary|Understand the Prevalence of Prosthetic Joint Infection|The trial failed primary outcome, and this secondary outcome was not analyzed|30 +/- 2 days||||||
23729|NCT01705496|Secondary|Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints|The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.|30 +/- 2 days||||||
23730|NCT01705496|Secondary|Evaluate the Safety and Tolerability of [124I]FIAU|Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.|30 +/- 2 days|22 received the investigational drug. A single IV injection of 5 mCi [124I]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.||participants with adverse events|||Number
23731|NCT01705496|Primary|Estimate the Sensitivity and Specificity of [124I]FIAU|"The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient’s infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.~Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used."|30 hours|Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.||percentage of participants||80% Confidence Interval|Number
23732|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI = (Weight [in kg]) divided by (Stature [in meters])^2. Data was reported as per the dose received and for overall participants.|Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
23733|NCT01705145|Primary|Part A: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (hydroxymethyl ivacaftor [M1] and ivacaftor carboxylate [M6]) up to 24 hours post-dose on Day 4 (Hour 0 [pre-dose] on Day 1 and Day 4; 2, 3, 6, 24 hours post-dose on Day 4). Data was planned to be reported for overall participants in the period.|Part A: up to 24 hours post-dose on Day 4|Part A Safety set included all participants who received at least 1 dose of study drug in part A.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
23734|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Stature at Week 24|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||centimeters (cm)||Standard Deviation|Mean
23735|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24|Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Deviation|Mean
23736|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.||millimole per liter (mmol/L)||Standard Deviation|Mean
23737|NCT01705145|Secondary|Part B: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (M1 and M6) up to 24 hours post-dose on Day 168 (Hour 0 [predose] on Day 1, 14, 56, 112, and 168; 2, 3, 6 hours post-dose on Day 14; 1 hour post-dose on Day 56; 4, 6 hours post-dose on Day 112; 24 hours post-dose on Day 168). Data was planned to be reported for overall participants in the period.|Part B: up to 24 hours post-dose on Day 168|Part B Safety set included all participants who received at least 1 dose of study drug in part B.||ng/mL||Standard Deviation|Mean
23738|NCT01705145|Primary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. AE includes both serious and non-serious AE. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received."|Part B: Up to 28 Weeks|Part B Safety set included all participants who received at least 1 dose of study drug in part B.||participants|||Number
26919|NCT01656161|Secondary|Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)||Days 1-169|||day*nmol/L||95% Confidence Interval|Geometric Mean
23739|NCT01705145|Primary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received and for overall participants."|Part A: Up to 93 Days|Part A Safety set included all participants who received at least 1 dose of study drug in part A.||participants|||Number
23740|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Left Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks|||Newton/seconds||Inter-Quartile Range|Median
23741|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Right Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks|||Newton/seconds||Inter-Quartile Range|Median
23742|NCT01704976|Secondary|Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks|||Newton||Inter-Quartile Range|Median
23743|NCT01704976|Secondary|Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks|||Newton||Inter-Quartile Range|Median
23744|NCT01704976|Primary|Physical Functional Performance|"Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living.~The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is “Poor performance”; SPPB 7-9 is “Intermediate performance; SPPB 10-12 is “High Performance”."|after 4 weeks|||units on a scale||Inter-Quartile Range|Median
23745|NCT01704846|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||hour|Participants|Geometric Coefficient of Variation|Geometric Mean
23746|NCT01704846|Secondary|Terminal Half-life (t1/2)|Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||hours|Participants|Geometric Coefficient of Variation|Geometric Mean
23747|NCT01704846|Secondary|Terminal Rate Constant (λz)|Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||1/h|Participants|Geometric Coefficient of Variation|Geometric Mean
23748|NCT01704846|Secondary|Time From Dosing to the Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum measured concentration of the analyte in plasma.~Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||hours|Participants|Standard Deviation|Mean
23749|NCT01704846|Secondary|Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.~Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||ng*h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
23750|NCT01704846|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
23751|NCT01704846|Primary|Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.~Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.||ng·h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
23800|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set||asthma control days||90% Confidence Interval|Least Squares Mean
30885|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers - Selenium|Biomarkers assessed primarily with plasma selenium as a change from baseline.|Baseline to 26 weeks|ITT population||ug/L||Standard Deviation|Mean
23752|NCT01704755|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.||Percentage of participants||95% Confidence Interval|Number
23753|NCT01704755|Secondary|Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
23754|NCT01704755|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm|A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
23755|NCT01704755|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
23756|NCT01704651|Secondary|Postoperative Ileus Incidence|Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.|Patients will be followed for 30 days postop|Intent to treat analysis||participants|||Number
23757|NCT01704651|Primary|Postoperative Length of Hospital Stay|Length of stay = date/time of hospital dismissal - date/time of end of surgery|Patients will be followed for the duration of their hospital stay, an expected average of 5 days|Intent to Treat analysis||days||Standard Deviation|Mean
23758|NCT01704599|Post-Hoc|EKG Categoryy Changes Related to Homocysteine Changes|Change in EKG ( normalize, unchanged, became abnormal) when homocysteine (Hcy) increased or decreased from week 16 on adalimumab to week 28 on adalimumab plus folic acid, vitamins B6 and B12 in adault psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.|Week 16 to Week 28|8 adults with moderate to severe plaque psoriasis ages 18-65. 4 were studied. Four were not because homocysteine levels at both Week16 nd 28 were not drawn(1 of the 4 had SAE prior to Week 16).||participants|||Number
23759|NCT01704599|Post-Hoc|Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.|Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28|Week 16 to Week 28 and Week 28 to post study day 70|8 Adults ages 18-65 with moderate tosevere plaque psoriasis. 7 subjects studied. The 8th had SAE prior to Week 16.||participants|||Number
23760|NCT01704599|Post-Hoc|PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF|Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis ages 18 to 65. Seven were analyzed. The one not analyzed had SAE prior to week16.||participants|||Number
23761|NCT01704599|Post-Hoc|PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3|Change in PASI from Week 16 on adalimumab to Week 28 on adalimumab, folic acid, vitamin B6 and B12 in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 Adult subjects ages 18-65 with moderate to severe plaque psoriasis. 7 had PASI data both Week 16 and Week 28. The 1 who did not had SAE prior to Week 16.||participants|||Number
23762|NCT01704599|Primary|Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change|PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28.|Weeks 16 and 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had PASI measured at weeks 16 and 28. One had SAE prior to week 16.||participants|||Number
23763|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasign and Decreasing Body Weight|Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study.|Week 16 and Week 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had weights taken weeks 0,4,16 and 28 allowing week16 and 28 analysis. One had weight taken only at weeks 0 and 4.||participants|||Number
23764|NCT01704599|Other Pre-specified|Number of Participants Who Fulfilled the Category of Having Height Measured|Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis.|Week 0 at Start of Adalimumab|8 Adults with mild to moderate plaque psoriasis had their height measured at week 0 in inches.||participants|||Number
23765|NCT01704599|Other Pre-specified|Number of Participants Within Categories of Body Temperature Change|Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Weeks 16 and 28|8 Subjects. Five had temperatures measured weeks 16 and 28. Three did not (one of the 3 had SAE prior to week16)||participants|||Number
23766|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:|Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12.|Week 16 and Week 28|of 8 adults with moderate to severe plaque psoriasis, Seven participants were measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. One who had SAE prior to Week 16 did not..||participants|||Number
23767|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)|Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study.|At screening|Only 1 of the 8 subjects was a woman of childbearing years during the study.||participant|||Number
23768|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody|Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study.|Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins|8 adult participants with moderate to severe plaque psoriasis with H. pylori titers measured during the 28 week study.||participants|||Number
23769|NCT01704599|Secondary|Number of Participants With Category Change in Serum Folic Acid Level.|Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|Weeks 16 and 28|8 particpantts with psoriasis. Five had folic acid levels drawn weeks 16 and 28. Three did not (one of the 3 had a SAE prior to week 16).||participants|||Number
23770|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level|Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis.|At Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. .Four of 8 had levels drawn at weeks 16 and 28. Four did not. Of the four whoi did not one had a SAE prior to Week 16.||participants|||Number
23771|NCT01704599|Secondary|Number of Participants With Category Change in Vitamin B12 Blood Level|Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|At Week 16 and Week 28|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Five of 8 had B12 measured at weeks 16 and 28. Three did not. One of the 3 had SAE prior to week 16.||participants|||Number
23772|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine|Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis..|Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis. 4 had levels measured at Week 16 and again at Week 28. Of the 4 not meausres 1 had a SAE prior to Week16.||participants|||Number
23773|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus|Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Week 16 then Week 28|8 adults 18-65 years having moderate to severe plaque psoriasis. Five had levels measured at week 16 and and again at week 28 . Three did not . Of the 3 1 had SAE prior to week 16.||participants|||Number
23774|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium|Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis.|Weeks 16 and 28|8 Adults age 18-65 with moderate to severe plaque psoriasis.Five had results both weeks 16 and 28. Three did npot (of these 1 had SAE prior to week 16)||participants|||Number
23775|NCT01704599|Other Pre-specified|Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)|Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. Five had CBCs at both week 16 and week 28. three did not ( one of the 3 had a SAE pripor to week 16)||participants|||Number
23776|NCT01704599|Secondary|Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)|Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high|At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination|8 adult subjects age 18-65 with moderate to sefver plaque psoriasis. Five subjects had VEGF levels taken weeks 16 and 28. Three ( one wiht SAE prior to week 16) did not.||participants|||Number
23801|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full Analysis set||symptom free days||90% Confidence Interval|Least Squares Mean
23802|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set||symptom free days||90% Confidence Interval|Least Squares Mean
31078|NCT01587079|Secondary|Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7|Change from baseline at evening 12-hour post-dose trough FEV1|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
23777|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)|An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study.|Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination|8 adults with moderate to severe plaque psoriasis. Seven evaluated at weeks 0,16 and 28 for no change in electrocardiogram (EKG) , worsening arrhymia or improvement of arrhythmia at weeks 16 and 28. Five of 8 studied weeks 0,16 and 28; 1 at week 16 and 28. Two (one with the SAE prior to Week 16) did not have EKGs both at weeks 16 and 28.||participants|||Number
23778|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)|A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28.|By Week 16, by Week 28 and by Day 70 post Week 28.|Adults ages 18-65 with moderate to severe plaque psoriasis.||participants|||Number
23779|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and Not Having an Adverse Event|"Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study:~AE Humira only"|After Week 16 of study|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Seven assessed after week 16 and at Week 28 of study and assessed at day 70 post week 28 visit ( the latter by telephone). One subject had SAE prior to vitamin addition.||participants|||Number
23780|NCT01704599|Secondary|Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change|DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12).|Week 16 and Week 28|8 adults with moderate to severe plaque psoriasis measured at weeks 16 and 28. Seven were measured weeks 16 and 28. One had SAE prior to week 16.||participants|||Number
23781|NCT01704599|Secondary|Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):|Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. 7 had static PGA scores weeks 16 and 28 and one had sPGA but SAE prior to week 16.||participants|||Number
23782|NCT01704521|Primary|Number of Participants With Sustained Virological Response at Week 12 (SVR12)|"Viral kinetic assessment using SVR 12 to either lead-in 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment."|Post-treatment at week 12|See baseline characteristics||participants|||Number
23783|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at 1 Month||at 1 month|PK analysis set||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
23784|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at Day 7||Day 7|PK analysis set||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
23785|NCT01704495|Secondary|Number of Uncontrolled Persistent Asthma Weeks During Treatment||Day 1 to end of the 6 months treatment period|Full analysis set||uncontrolled persistent asthma weeks||Standard Deviation|Mean
23786|NCT01704495|Secondary|Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline||Last 2 weeks before randomization|Full analysis set||participants|||Number
23787|NCT01704495|Secondary|Number of Well Controlled Asthma Weeks During Treatment||Day 1to end of the 6 months treatment period|Full Analysis set||well controlled asthma weeks||Standard Deviation|Mean
23788|NCT01704495|Secondary|Number of Participants With Well Controlled Asthma Weeks at Baseline||Last 2 weeks before randomization|||participants|||Number
23789|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
23790|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)|full analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
23791|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)|Full Analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
23792|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set||night time awakenings||90% Confidence Interval|Least Squares Mean
23793|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)|Full Analysis set||rescue medication free days||90% Confidence Interval|Least Squares Mean
23794|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|||rescue medication free days||90% Confidence Interval|Least Squares Mean
23805|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||Participants with improvement|||Number
23806|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0), Treatment Period (1,3, and 6 months)|||Overall Score||90% Confidence Interval|Least Squares Mean
23807|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||Participants with improvement|||Number
23808|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)|Full Analysis set||Units on a scale]||90% Confidence Interval|Least Squares Mean
23809|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
23810|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
23811|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
23812|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
23813|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
23814|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0|||L||90% Confidence Interval|Least Squares Mean
23815|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set||L||90% Confidence Interval|Least Squares Mean
23816|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
23817|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
23818|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
23819|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0|||L||95% Confidence Interval|Least Squares Mean
23820|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0|Full analysis set||L||90% Confidence Interval|Least Squares Mean
23821|NCT01704495|Secondary|Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms||From start of treatment up to 6 months|Full analysis set||Days||90% Confidence Interval|Least Squares Mean
23822|NCT01704495|Secondary|Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions||From start of treatment up to 6 months|Full analysis set||Days||90% Confidence Interval|Least Squares Mean
23823|NCT01704495|Secondary|Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months||From start of treatment up to 6 months|||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
23825|NCT01704261|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24.|24 weeks|The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.||Percentage of participants||95% Confidence Interval|Number
23826|NCT01704261|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
23827|NCT01704261|Primary|Percentage of Participants Who Discontinued From the Study Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 24|The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.||Percentage of participants|||Number
23828|NCT01704261|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 27|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.||Percentage of participants|||Number
23829|NCT01704261|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.||%A1C||95% Confidence Interval|Least Squares Mean
23830|NCT01704079|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol||participants|||Number
23831|NCT01704079|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat||participants|||Number
23832|NCT01704079|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders|Approximately 6 months|Per protocol||participants|||Number
23833|NCT01704079|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders|Approximately 6 months|Intent to treat||participants|||Number
23834|NCT01703858|Secondary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
23835|NCT01703858|Primary|Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)|Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
23836|NCT01703858|Primary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
24165|NCT01699022|Primary|Serum Progesterone Concentration|"Return of ovulation measured by changes in serum progesterone concentration by~analysis on Day 18, Day 21 (Control cycle), Day 103, Day 106, Day 131 and Day 134 indicating the number of subjects who achieved ovulation"|Day 134|||participants|||Number
23837|NCT01703845|Secondary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG|"Outcome data show are the number of participants with clinically relevant abnormalities reported as an adverse event (AE) related to the vital signs (pulse rate and blood pressure in supine position), clinical laboratory (routine blood chemistry, haematology, and urinalysis) tests and ECG (12-lead holter monitoring Electrocardiography). Relevant findings or worsening of baseline conditions were reported as adverse events.~There were no clinically relevant abnormalities reported as an AE related to the vital signs and ECG."|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|The treated Set (TS).||participants|||Number
23838|NCT01703845|Primary|CLR,t1-t2,ss (Tiotropium)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.~Plasma concentration of tiotropium could not be quantified up to 4 hours for Tiotropium + Olodaterol (2.5μg/5μg)."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||mL/min||Geometric Coefficient of Variation|Geometric Mean
23839|NCT01703845|Primary|fe t1-t2,ss (Tiotropium)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
23840|NCT01703845|Primary|Aet1-t2,ss (Tiotropium)|"Amount of tiotropium that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
23841|NCT01703845|Primary|Tmax,ss (Tiotropium)|"Time from dosing to the maximum concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||h||Full Range|Median
23842|NCT01703845|Primary|AUC0-tz,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
23843|NCT01703845|Primary|AUCt1-t2,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 2 hours at steady state (AUCt1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1 and 2 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
23844|NCT01703845|Primary|Cmax,ss (Tiotropium)|"Maximum measured concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
23845|NCT01703845|Secondary|Number of Participants With Adverse Events (Including Assessment Based on Physical Examination)|Outcome data show are the number of patients with an adverse event including the assessment based on physical examination.|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|Treated Set (TS) includes all randomised patients who received at least one dose of trial medication.||participants|||Number
23846|NCT01703845|Primary|CLR,t1-t2,ss (Olodaterol)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||mL/min||Geometric Coefficient of Variation|Geometric Mean
23847|NCT01703845|Primary|fe t1-t2,ss (Olodaterol)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
23848|NCT01703845|Primary|Aet1-t2,ss (Olodaterol)|"Amount of olodaterol that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
23849|NCT01703845|Primary|Tmax,ss (Olodaterol)|"Time from dosing to the maximum concentration of Olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3 and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.||h||Full Range|Median
23850|NCT01703845|Primary|AUC0-tz,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
24166|NCT01699022|Primary|T1/2|Mean no of days for MPA and E2|"Day 85"|Tmax||day||Standard Deviation|Mean
23851|NCT01703845|Primary|AUCt1-t2,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (AUCt1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
23852|NCT01703845|Primary|Cmax,ss (Olodaterol)|"Maximum measured concentration of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set was defined as all treated patients who have at least 1 PK parameter in the treatment period without PK related important protocol violations. Two patients prematurely stopped the trial medication and had no PK measurement at Visit 3 (day 21) and were excluded from the PK set. Thus, the PK set included 30 patients.||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
23853|NCT01703832|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: “How much do you currently suffer from” (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
23854|NCT01703832|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
23855|NCT01703832|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||beats per minute||Full Range|Median
23856|NCT01703832|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mmHg||Full Range|Median
23857|NCT01703832|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 12 participants randomized to Natural Course could be evaluated for NK cells||percentage of lymphocytes||Full Range|Median
23858|NCT01703832|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Norepinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
23859|NCT01703832|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Epinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
24167|NCT01699022|Primary|Tmax|Mean serum concentrations of E2 peaked by 3.3 days (range 1 – 7 days) following the third monthly injection|"Day 85"|Tmax||day||Standard Deviation|Mean
23860|NCT01703832|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For the plasma Cortisol evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient sample.||nmol/L||Full Range|Median
23861|NCT01703832|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 to Natural Course and all randomized participants were included in the Safety Set. For plasma ACTH evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient samples and the -60 min time-point had 30 evaluable Neurexan participants.||ng/L||Full Range|Median
23862|NCT01703832|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||nmol/mL||Full Range|Median
23863|NCT01703832|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minute, +15 minute , + 45 minute, +100 minute|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for efficacy. Note: -60 minute time-point had 31 evaluable Neurexan participants.||IU/mL||Full Range|Median
23864|NCT01703832|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
23865|NCT01703832|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
23866|NCT01703819|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: “How much do you currently suffer from” (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
23867|NCT01703819|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before the stress test and were repeated at 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||units on a scale||Full Range|Median
24168|NCT01699022|Primary|E2 Pharmacokinetics|AUC 0-28, AUC(0-inf)|Day 28|||pg.day/mL||Standard Deviation|Mean
23868|NCT01703819|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||beats per minute||Full Range|Median
23869|NCT01703819|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mmHg||Full Range|Median
23870|NCT01703819|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 16 participants randomized to Placebo could be evaluated for NK cells.||percentage of lymphocytes||Full Range|Median
23871|NCT01703819|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Norepinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
23872|NCT01703819|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Epinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
23873|NCT01703819|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Cortisol, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.||nmol/L||Full Range|Median
23874|NCT01703819|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma ACTH, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.||ng/L||Full Range|Median
23875|NCT01703819|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||nmol/mL||Full Range|Median
23876|NCT01703819|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol, alpha amylase, Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||IU/mL||Full Range|Median
23877|NCT01703819|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0~= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
23928|NCT01703000|Secondary|Cardiac Death or MI Rate|"Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
31079|NCT01587079|Secondary|Peak Change From Baseline IC on Day 7|Peak change from baseline IC|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
23878|NCT01703819|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0~= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.||mm*min||Full Range|Median
23879|NCT01703702|Secondary|Change in Patient Management: Individual Categories|Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer’s/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||percentage of patients|||Number
23880|NCT01703702|Secondary|Change in Caregiver Self-efficacy|Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers’ self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||units on a scale||Standard Error|Least Squares Mean
23881|NCT01703702|Secondary|Change in Patient Management: Advice/Counseling|Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||percentage of patients|||Number
23882|NCT01703702|Secondary|Change in Diagnostic Confidence|Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.||Percentage Point||Standard Error|Least Squares Mean
23883|NCT01703702|Secondary|Change in Patient's Clinical Diagnosis|Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was not predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.||percentage of patients|||Number
23884|NCT01703702|Primary|Change in ADAS-Cog 11 Total Score|Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 12 months|Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value.||units on a scale||Standard Error|Least Squares Mean
23885|NCT01703702|Primary|Clinical and Diagnostic Change in Patient Management|Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.||percentage of patients|||Number
23886|NCT01703663|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.|night 1 and night 2|||apneas plus hypopneas per hour||Inter-Quartile Range|Median
23887|NCT01703286|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events|up to 20 weeks|Treated set (TS)||participants|||Number
23888|NCT01703286|Secondary|Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28|Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.||percentage||90% Confidence Interval|Mean
23889|NCT01703286|Secondary|Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28|Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|||Percentage||90% Confidence Interval|Geometric Mean
24169|NCT01699022|Primary|E2 Concentrations|Mean serum E2 concentrations on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and ''Day 85"|||pg/mL||Standard Deviation|Mean
23890|NCT01703286|Primary|Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28|Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.||percentage||90% Confidence Interval|Geometric Mean
23891|NCT01703260|Secondary|Change From Baseline in Liver Fat Content at Month 4|Liver fat content was quantitatively measured by evaluating the percentage of PDFF from an abdominal MRI. On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline and Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.||percent change in PDFF||Standard Deviation|Mean
23892|NCT01703260|Secondary|Liver Fat Content at Baseline|Liver fat content was quantitatively measured by evaluating the percentage of proton density fat fraction (PDFF) from an abdominal magnetic resonance imaging (MRI). On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.||percentage of PDFF||Standard Deviation|Mean
23893|NCT01703260|Secondary|Percent Change From Baseline in Serum AST at Month 4|The percent change between the serum AST value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.||percent change||Standard Deviation|Mean
23894|NCT01703260|Secondary|Amount of Serum Aspartate Transaminase (AST) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.||IU/L||Standard Deviation|Mean
23895|NCT01703260|Primary|Percent Change From Baseline in Serum ALT at Month 4|The percent change between the serum ALT value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.||percent change||Standard Deviation|Mean
23896|NCT01703260|Primary|Amount of Serum Alanine Transaminase (ALT) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.||international units per liter (IU/L)||Standard Deviation|Mean
23897|NCT01703221|Secondary|Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.||mg/dL||95% Confidence Interval|Least Squares Mean
23898|NCT01703221|Secondary|Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.||mg/dL||95% Confidence Interval|Least Squares Mean
23899|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.||Percentage of participants|||Number
23900|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug.||Percentage of participants|||Number
23901|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.||Percentage of Participants|||Number
23929|NCT01703000|Secondary|All Death Rate|Death is categorized as cardiac or non-cardiac deaths.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23902|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During Phase A|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.||Percentage of participants|||Number
23903|NCT01703221|Primary|Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).|Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.||Percent HbA1c||95% Confidence Interval|Least Squares Mean
23904|NCT01703091|Secondary|Change From Baseline in Lung Cancer Symptom Scale (LCSS)|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Millimeter||Standard Deviation|Mean
23905|NCT01703091|Secondary|Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score|The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Units on a Scale||Standard Deviation|Mean
23906|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Percentage of Participants||95% Confidence Interval|Number
23907|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.||Percentage of Participants||95% Confidence Interval|Number
23908|NCT01703091|Secondary|Overall Survival (OS)|OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Baseline to Death from Any Cause (Up to 28 Months)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 36 and 35, respectively.||Months||95% Confidence Interval|Median
23925|NCT01703000|Secondary|Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)|"Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.~Timing:~Acute stent thrombosis*: 0 24 hours after stent implantation~Subacute stent thrombosis*: >24 hours to 30 days after stent implantation~Late stent thrombosis: >30 days to 1 year after stent implantation~Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.~Stent thrombosis may be defined as:~Confirmed/definite~Probable~Possible~Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
24170|NCT01699022|Primary|MPA Pharmacokinetics T1/2||"Day 85"|||day||Standard Deviation|Mean
23909|NCT01703091|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow‑up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)|Full Analysis Set (FAS) population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 13 and 9, respectively.||Months||95% Confidence Interval|Median
23910|NCT01703000|Secondary|Longitudinal Stent Deformation|Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of stents|||Number
23911|NCT01703000|Secondary|Percent Net Volume Obstruction|The percentage of volume obstruction, as measured by the IVUS core lab.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||% of volume|Participants|Standard Deviation|Mean
23912|NCT01703000|Secondary|Incomplete Apposition|"Incomplete apposition rate, as measured by the IVUS core lab.~Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS)."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of lesions|Participants||Number
23913|NCT01703000|Secondary|Lumen Volume|As measured by IVUS, the volume of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^3|Participants|Standard Deviation|Mean
23914|NCT01703000|Secondary|Stent Volume|As measured by IVUS, the volume of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^3|Participants|Standard Deviation|Mean
23915|NCT01703000|Secondary|Vessel Volume|As measured by IVUS, the volume of the vessel.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^3|Participants|Standard Deviation|Mean
23916|NCT01703000|Secondary|Lumen Area|As measured by IVUS, the area of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^2|Participants|Standard Deviation|Mean
23917|NCT01703000|Secondary|Stent Area|As measured by IVUS, the area of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^2|Participants|Standard Deviation|Mean
23918|NCT01703000|Secondary|Vessel Area|As measured by IVUS, the mean vessel area (mm2).|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm^2|Participants|Standard Deviation|Mean
23919|NCT01703000|Secondary|Acute Gain|Acute gain, as measured by angiographic core lab|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm||Standard Deviation|Mean
23920|NCT01703000|Secondary|In-segment Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).~The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm|Participants|Standard Deviation|Mean
23921|NCT01703000|Secondary|In-stent Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.~The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||mm|Participants|Standard Deviation|Mean
23922|NCT01703000|Secondary|In-segment Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).~Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||Diameter Stenosis, In-Segment (%)|Participants|Standard Deviation|Mean
23923|NCT01703000|Secondary|In-stent Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.~Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||In-Stent % Diameter Stenosis|Participants|Standard Deviation|Mean
23924|NCT01703000|Secondary|Clinical Procedural Success Rate|"Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of participants||95% Confidence Interval|Number
23926|NCT01703000|Secondary|All Death/MI/TVR Rate|"Any event meeting the pre-specified criteria for any death, MI, or TVR.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23927|NCT01703000|Secondary|All Death or MI Rate|"Any all-cause mortality event or MI meeting the criteria defined for any death or MI.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23930|NCT01703000|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as a death not due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~CVA through hospital discharge or CVA suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23931|NCT01703000|Secondary|Cardiac Death Rate|"Cardiac death is defined as death due to any of the following.~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~CVA through hospital discharge or CVA suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23932|NCT01703000|Secondary|Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate|MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23933|NCT01703000|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.~The MI definition used was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23934|NCT01703000|Secondary|Target Vessel Revascularization (TVR) Rate|"Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:~The subject has a positive functional study corresponding to the area served by the target vessel.~The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.~The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23935|NCT01703000|Secondary|Target Lesion Failure (TLF) Rate|"Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non–Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.~The MI definition used for Target Lesion Failure was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23936|NCT01703000|Secondary|Target Lesion Revascularization (TLR) Rate|"Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:~The subject has a positive functional study corresponding to the area served by the target lesion.~The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.~The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days|||percentage of participants|||Number
23937|NCT01703000|Primary|Technical Success Rate|Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of lesions|Participants|95% Confidence Interval|Number
23938|NCT01702961|Secondary|Number of Participants With Overall Best Response Achieved After Transplantation|Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.|3 months post-transplant|Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin’s disease.||participants|||Number
23939|NCT01702961|Secondary|Median Days to Neutrophil Engraftment|Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.|30 days post-transplant|All of the participants enrolled in the study engrafted.||days||Full Range|Median
23940|NCT01702961|Primary|Disease-free Survival|Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin’s lymphomas|12 months post-transplant|||percentage of participant||95% Confidence Interval|Number
23981|NCT01702311|Secondary|Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg|daily while in hospital for up to 10 days||||||
23982|NCT01702311|Secondary|Bacteremia|Bacteremia with SIRS/Sepsis|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23983|NCT01702311|Secondary|Pneumonia|Pneumonia (CDC criteria)|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23941|NCT01702532|Secondary|The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes|Participants completed a cigarette craving assessment consisting of the following five items: “I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .|Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes|||mm||95% Confidence Interval|Least Squares Mean
23942|NCT01702532|Primary|The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds|Participants completed a cigarette craving assessment consisting of the following five items: “I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.|Pre-dosing post-provocation to 50 seconds|All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.||mm||Inter-Quartile Range|Least Squares Mean
23943|NCT01702519|Secondary|Rate of Elimination (Kel)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Elimination rate constant for nicotine was determined from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Elimination rate constant for nicotine was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the study medications, had no protocol violations, and whose data was considered evaluable by the pharmacokineticist.||1/hr||Full Range|Median
23944|NCT01702519|Secondary|Plasma Half-life (t1/2)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. The elimination half-life of nicotine was determined by from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Plasma half-life (t1/2) was based on the baseline adjusted nicotine plasma concentration data|Baseline to 32 hours|Per-prorocol population, which included all randomized participants who received at least one dose of the study treatment, had no protocol violation, and whose data was considered evaluable by the pharmacokineticist.||Hrs||Full Range|Median
23945|NCT01702519|Secondary|Time to Maximum Plasma Concentration (Tmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Time to Maximum Plasma Concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points; immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application of the patch. Patch was then removed after the collection of 24 hour blood sample. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the drug, did not have any protocol deviations and whose data was considered evaluable by the pharmacokineticist.||hrs||Full Range|Median
23946|NCT01702519|Secondary|Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Area under the plasma nicotine concentration time curve from zero extrapolated to infinity was determined by plasma concentration time profile of nicotine. Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -inf) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.||ng*h/mL||Standard Deviation|Mean
23947|NCT01702519|Primary|Maximum Measured Plasma Concentration (Cmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.||ng/mL||Standard Deviation|Mean
23948|NCT01702519|Primary|Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.||nanogram (ng)*hour (hr)/milliliter (mL)||Standard Deviation|Mean
23949|NCT01702454|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
23950|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 28 days (Days 0-27) after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
23951|NCT01702454|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology.|During the entire study period (Days 0 - 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
23952|NCT01702454|Secondary|Number of Subjects Reporting AEs With Medically Attended Visits (MAV)|MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.|During the entire study period (Day 0 – Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
23953|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature > 39.0°C.|During the 7 days (Days 0 – 6) post dose 1 vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
23954|NCT01702454|Secondary|Duration of Solicted Symptoms|Duration was defined as number of days with any grade of solicted local and/or general symptoms|During the 7-day (Days 0-6) post-vaccination Dose 1 period|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
23955|NCT01702454|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|During a 7-day (Day 0 to 6) follow-up period after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
23956|NCT01702454|Primary|Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
23957|NCT01702454|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
23958|NCT01702454|Primary|Number of Subjects Seroconverted for HI Antibodies Against Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
48294|NCT01342458|Secondary|Paracetamol Intake|Paracetamol intake (500 mg), number of tablets per month.|6 month|||tablets per month||Inter-Quartile Range|Median
23959|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
23960|NCT01702454|Secondary|VRR for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
23961|NCT01702454|Secondary|MGI for Neutralising Antibodies Titres Against Each of the Four Vaccine Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.|At Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
23962|NCT01702454|Secondary|Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
23963|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
23964|NCT01702454|Secondary|Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
23965|NCT01702454|Secondary|Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
23966|NCT01702454|Primary|Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Subjects|||Number
23967|NCT01702454|Primary|Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
23984|NCT01702311|Secondary|Nosocomial Infections (CDC)|Nosocomial infections during hospital stay as per the CDC criteria|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23985|NCT01702311|Secondary|Hospital Mortality|Mortality is defined as death occurring during admission or during the hospital stay|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23968|NCT01702363|Secondary|Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
23969|NCT01702363|Secondary|Change From BL in Heart Rate Throughout the Treatment Period|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters or at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||beats per minute||Standard Deviation|Mean
23970|NCT01702363|Secondary|Change From BL in Blood Pressure Throughout the Treatment Period|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||millimeters of mercury (mmHg)||Standard Deviation|Mean
23971|NCT01702363|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per Liter (MMOL/L)||Standard Deviation|Mean
23972|NCT01702363|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per Liter (µM/L)||Standard Deviation|Mean
23973|NCT01702363|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||International Units per Liter (IU/L)||Standard Deviation|Mean
23974|NCT01702363|Secondary|Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of red blood cells in blood||Standard Deviation|Mean
23975|NCT01702363|Secondary|Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per Liter (G/L)||Standard Deviation|Mean
23976|NCT01702363|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per Liter (GI/L)||Standard Deviation|Mean
23977|NCT01702363|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of cells in blood||Standard Deviation|Mean
23978|NCT01702363|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|From the first dose of study medication up to 52 weeks|ITT Population||Participants|||Number
23979|NCT01702363|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the first dose of study medication up to 52 weeks|Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.||Participants|||Number
23980|NCT01702311|Secondary|Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]|Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23986|NCT01702311|Secondary|Length of Hospital Stay|Length of hospitalization|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23988|NCT01702311|Secondary|Number of Hypoglycemia (BG < 70 mg/dl) and Severe Hyperglycemia (BG>300 mg/dl)|Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) and severe hyperglycemia (BG>300 mg/dl) among both the groups.|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23989|NCT01702311|Secondary|Mean Daily BG and Number of BG Within Target|Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG and number of BG within target|participants will be followed for the duration of hospital stay, an expected average of 6 days||||||
23990|NCT01702311|Primary|Mean Fasting Blood Glucose|The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.|up to 10 days|||mg/dL||Standard Deviation|Mean
23991|NCT01702298|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of HDL-C.||Percent change||95% Confidence Interval|Least Squares Mean
23992|NCT01702298|Secondary|Change From Baseline in Triglycerides (TG)|Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS.||Percent change||95% Confidence Interval|Median
23993|NCT01702298|Secondary|Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)|Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.||Percent change||95% Confidence Interval|Least Squares Mean
23994|NCT01702298|Secondary|Change From Baseline in Total Cholesterol (TC)|Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|"FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements.~One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of TC."||Percent change||95% Confidence Interval|Least Squares Mean
23995|NCT01702298|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of LDL-C.||Percent change||95% Confidence Interval|Least Squares Mean
23996|NCT01702298|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.|Up to 6 weeks|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.||Participants|||Number
23997|NCT01702298|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 8 weeks (including 14 days after final dose of study drug)|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
23998|NCT01702298|Primary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.|Baseline and Week 6|Full analysis set (FAS) defined as all participants who took at least one dose of study medication and had at least one baseline or post-baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
23999|NCT01702259|Secondary|Patient Satisfaction With Study Outcome|"At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:~Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied~Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|2 Weeks|||participants|||Number
24000|NCT01702259|Secondary|Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.|The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.|Baseline and 2 weeks|The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.||percentage of TBSA||Standard Deviation|Mean
24001|NCT01702259|Secondary|Change in Body Weight|Body weight is measured in pounds (lbs) using a digital scale.|Baseline and 2 weeks|||pounds||Standard Deviation|Mean
24002|NCT01702259|Secondary|Bilateral Upper Thigh Circumference Measurement|Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.|Baseline and 2 weeks|||inches||Standard Deviation|Mean
50722|NCT01313182|Secondary|Measure Hospital Length of Stay and Re-admission Rates in the Mupirocin and Povidone-iodine Groups.|Re-admission for infection within 12 months of procedure|12 months||||||
24003|NCT01702259|Primary|Number of Subjects That Met the Individual Success Criteria|The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.|Baseline and 2 weeks|||participants|||Number
24004|NCT01702246|Secondary|Change From Baseline in Total Cholesterol Level After Treatment With Simvastatin||Baseline and 3 months|change in baseline cholesterol level from baseline, after treatment with simvastatin||mmol/L||Standard Deviation|Mean
24005|NCT01702246|Secondary|Change in Plasma High Sensitivity C-reactive Protein|Mean difference in plasma high sensitivity C-reactive protein level, before and after treatment with simvastatin|Baseline and 3 months|||mg/mL||Standard Deviation|Mean
24006|NCT01702246|Primary|Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin|The effect of simvastatin treatment will be assessed by measuring the difference from baseline in the mean frequency (and intensity) of vaso-occlusive pain events, after treatment with simvastatin. Pain rate (proportion of pain days) was defined as the number of days reported with sickle cell disease-related pain divided by the number of daily pain diaries completed.|Baseline and 3 months|||proportion of pain days||Standard Deviation|Mean
24007|NCT01702233|Secondary|Change From Baseline in DASH at Visit 7 (Day 105)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers.target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy"|Baseline vs. Day 105|||DASH score||Standard Deviation|Mean
24008|NCT01702233|Secondary|Change From Baseline in DASH at Visit 5 (Day 22)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy.~The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers."|Baseline vs. Day 22|||DASH score||Standard Deviation|Mean
24009|NCT01702233|Secondary|Painful Arc Test at Visit 5 (Day 22)|The amount of pain that disappeared by further abduction in the range between 60° and 120° was to be measured, with measurement of pain being positive/negative. The idea behind the test is the subacromial space in abduction becomes smaller, whereby compression of the rotator cuff and the subacromial bursa occurs (impingement test).|Baseline vs. day 22|||participants|||Number
24010|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 22) With Measurement of Weakness|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician’s attempts to depress the upper arm to look for muscle weakness.|Baseline vs. day 22|||participants|||Number
24011|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 15) With Measurement of Pain|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician’s attempts to depress the upper arm to look for muscle weakness.|Baseline vs. Day 22|||participants|||Number
24012|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 105|||degrees||Standard Deviation|Mean
24013|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22|||degrees||Standard Deviation|Mean
24014|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. day 105|||degrees||Standard Deviation|Mean
24015|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22|||degrees||Standard Deviation|Mean
24016|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Fortecortin at Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. day 105|||units on a scale, mm||Standard Deviation|Mean
24017|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Placebo Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 105|||units on a scale, mm||Standard Deviation|Mean
24171|NCT01699022|Primary|MPA Pharmacokinetics Tmax|Mean serum MPA concentrations peaked at 4.1 days (range 1 – 21 days) after the third monthly administration of Cyclofem.|"Day 85"|||day||Standard Deviation|Mean
24018|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Placebo Visit 5 (Day 22)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 22|||Change in mm baseline vs. day 22||Standard Deviation|Mean
24019|NCT01702233|Primary|Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). Change = (Day 22 score -- baseline score).|Baseline to Day 22|Per protocol population||units on a scale (mm)||Standard Deviation|Mean
24020|NCT01702025|Primary|Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).|After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.|The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia|||minutes||Standard Error|Mean
24021|NCT01701999|Other Pre-specified|Collected Plasma Volume|Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.|Week 1 to Week 12|Participants in Part 1 were only analyzed for safety data, and one participant in Part 2 was excluded from plasma collection due to not meeting the plasma donor minimum weight requirement.||mL||Standard Deviation|Mean
24022|NCT01701999|Secondary|Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve|Proportion of participants achieving a two-fold increase in the area under the plasma NAC-time curve between Week 0 and Week 12 in comparison with a straight-line extension of the Week 0 NAC to Week 12 for both botulinum toxin A and toxin B. A proportion ≥ 0.50 was considered a success.|Week 0 to Week 12|||proportion of participants|||Number
24023|NCT01701999|Secondary|Three-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a three-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success)|Week 0 to Week 4|||proportion of participants|||Number
24024|NCT01701999|Primary|Four-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a four-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success).|Week 0 to Week 4|||proportion of participants|||Number
24025|NCT01701622|Secondary|If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)|measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.|Participants will be followed for an expected average of 4 to 5 weeks.||||||
24026|NCT01701622|Primary|BP Differences While on Allopurinol and Febuxostat by Clinic and Pressure Readings and 24-hour Ambulatory Blood Pressure Readings.|The following data will be collected: general demographic information, uric acid, casual blood pressure readings, 24-hour ambulatory blood pressure readings, including mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.|Participants will be followed for an expected average of 4 to 5 weeks.||||||
24027|NCT01701414|Primary|Number of Participants Reporting at Least One NRS Rating|Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.|30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.|||Participants|||Number
24028|NCT01701401|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR~Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment~Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Baseline to posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
24029|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
24030|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
24031|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
24032|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
24033|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
24034|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
24035|NCT01701401|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug|SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
24036|NCT01701401|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
24037|NCT01701401|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)|SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
24038|NCT01701375|Secondary|To Determine the Maximal Tolerated Dose (MTD) of PD 0332991 in Timed Sequential Combination With Ara-C and Mitoxantrone|Dose escalation decisions will be based on nonhematologic toxicities in Cycle 1 (28 days) and hematologic toxicities, in the case of an aplastic marrow through Day 56, For cytopenias including ANC < 500/mm3 or platelets < 50, 000/mm3 a bone marrow will be performed between days 42 and 49.. Dose limiting toxicity (DLT) will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days||||||
24039|NCT01701375|Primary|The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.|The number of participants experiencing toxicities of administration of PD 0332991 in combination with cytarabine and mitoxantrone will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days|||participants|||Number
24040|NCT01701271|Primary|Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.|Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis||hairs/square inch||Full Range|Mean
24041|NCT01701271|Secondary|Change of Sebum on a Sebum-meter|Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.|baseline and 90 days|Good state of general health Suffering from hair loss||mg sebum/c^2||Full Range|Mean
24042|NCT01701271|Primary|Change of the Amount of Hair Loss in a Pull Test|"Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.~Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair"|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis||Fallen hair||Full Range|Mean
24043|NCT01701245|Secondary|EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.~Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index~Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state"|10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks)|Changes between baseline and randomized period.Randomized period and open label. FAS Unmatched data.||units on a scale||Full Range|Mean
24044|NCT01701245|Secondary|Adverse Events|The frequency of device effects will be compared between the two treatment groups. Only effects which are new after baseline or have increased severity after baseline will be used in the comparison.|10 weeks|Safety population The Adverse Device effects are reported as Adverse Event, the device effects are AEs that are considered related to the treatment. Graded mild, moderate and severe||participants|||Number
24045|NCT01701245|Secondary|Pain Relief of Headache Attacks|"The median pain during baseline (2 weeks) will be compared with the last 14 days of the treatment period Scale 0-4 0= no pain~mild pain~moderate pain~severe pain~very severe pain"|baseline (2 weeks) and random period(last 2 weeks)|"Median severity per subject in run in period (14 days) and the last 14 Days in the treatment period.~FAS matched data set"||participants|||Number
24046|NCT01701245|Primary|A Change in the Frequency of Cluster Headache Attacks Per Week|The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) – number of CH attacks during run-in.|4 weeks|Full analysis set (FAS), matched group.||CH attacks per week||Standard Deviation|Mean
24047|NCT01701102|Primary|Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)|The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery|Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.|||minutes||Inter-Quartile Range|Median
24048|NCT01701063|Secondary|Elimination Half-Life (T1/2) of Telaprevir|T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Half life was not calculated because the calculation required the slope of terminal elimination phase and the PK sampling was relatively sparse and did not yield a terminal elimination phase from which half-life can be accurately estimated.|||||
24087|NCT01700387|Primary|Physician Global Impression of Change (PGIC)|Score on Physician Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.||units on a scale||Standard Deviation|Mean
24088|NCT01700387|Primary|Subject Global Impression of Change (SGIC)|Score on Subject Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.||units on a scale||Standard Deviation|Mean
24049|NCT01701063|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir|AUC was measured for telaprevir only. AUC 0-t last was defined as the area under the concentration-time curve from the time of dosing to the last measurable concentration. AUC 0-12 hour (AUC 0-12h) was calculated by respecifying predose concentrations as 12 hour concentrations. AUC 0-24h was calculated as AUC 0-12h multiplied by 2. Dose adjusted AUC (AUC 0-24h_Adj) was calculated by multiplying AUC 0-24h by the dose adjustment factor to obtain projected exposures in participants who were misdosed. Data were presented for AUC 0-t last, AUC 0-12h, AUC 0-24h, AUC 0-24h_Adj.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
24050|NCT01701063|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir|Tmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.||hours (h)||Full Range|Median
24051|NCT01701063|Secondary|Maximum Plasma Concentration (Cmax) of Telaprevir|Cmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Pharmacokinetic (PK) population included all participants who received at least a single dose of telaprevir, whether the participant completed all treatments or not. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
24052|NCT01701063|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by age.|Baseline, On treatment (up to Week 48)|FAS. Here ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome and ‘n’ signifies those who were evaluable at the specified time point.||participants|||Number
24053|NCT01701063|Secondary|Percentage of Participants With Virologic Relapse|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Viral relapse was defined as having detectable HCV at follow-up in participants who had HCV RNA less than (<) lower limit of quantification (LLOQ) at planned EOT.|12 weeks after planned EOT (up to Week 60)|FAS included all enrolled participants who received at least 1 dose of study drug. Here 'Number of Participants Analyzed' signifies those participants who completed the assigned treatment period and had undetectable HCV RNA at EOT.||percentage of participants|||Number
24054|NCT01701063|Secondary|Percentage of Participants With On-treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Futility rules: 1) HCV RNA >1000 IU/mL at Week 4; 2) HCV RNA >1000 IU/mL at Week 12; 3) Detectable HCV RNA after Week 12 to end of treatment.|Baseline up to Week 48|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
24055|NCT01701063|Secondary|Percentage of Participants With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
24056|NCT01701063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. eRVR was defined as an undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
24057|NCT01701063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. RVR was defined as an undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|FAS included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
24058|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (< lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|SVR24 was not analyzed because study was terminated early and follow-up was conducted only up to 12 weeks after planned end of treatment (EOT).|||||
24059|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (less than [<] lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/High Pure System (HPS) RNA assay version 2.0. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study drug.||percentage of participants|||Number
24089|NCT01700387|Primary|Subject Attrition Post Randomization|Count of subject attrition following randomization and reason for attrition (Consent withdrawn, Withdrawn due to adverse event, Lost to follow up)|Collected on Visit 2 (Day 29) through Visit 6 (Day 365)|||participants|||Number
24060|NCT01701063|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 52|Safety set included all participants who received at least 1 dose of study drug.||participants|||Number
24061|NCT01701024|Primary|Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear||Baseline and 12 Weeks|||percentage of clear or almost clear|||Number
24062|NCT01701024|Primary|Percent of Subjects Who Have a Least a 2 Grade Reduction||Baseline and 12 Weeks|||Percent with >2% reduction|||Number
24063|NCT01701024|Primary|Absolute Change in Non-inflammatory Lesion Count||Baseline and 12 Weeks|||lesion count||Standard Deviation|Mean
24064|NCT01701024|Primary|Absolute Change in Inflammatory Lesion Count||Baseline and 12 Weeks|||Lesion count||Standard Deviation|Mean
24065|NCT01701011|Secondary|Depression|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0–7), mild (8–10), moderate (11–14) and severe (15–21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer||units on a scale||Standard Error|Mean
24066|NCT01701011|Primary|Anxiety|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0–7), mild (8–10), moderate (11–14) and severe (15–21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer||units on a scale||Standard Error|Mean
24067|NCT01700907|Secondary|The Incidence of Postoperative Delirium|The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.|from 15 minutes to 48 hrs postoperatively|This is a pilot study.||participants|||Number
24068|NCT01700907|Secondary|Cognitive Function|Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.|24 hrs pre and postoperatively|This is a pilot study||Scores on a scale||Inter-Quartile Range|Median
24069|NCT01700907|Secondary|The Time From the End of Anesthesia to Following Commands|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.||second||Inter-Quartile Range|Median
24070|NCT01700907|Secondary|The Time From the End of Anesthesia to Eye Opening|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.||second||Inter-Quartile Range|Median
24071|NCT01700907|Primary|The Time From the End of Anesthesia to Extubation|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.||second||Inter-Quartile Range|Median
24072|NCT01700530|Secondary|Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)|% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention|12 weeks|||percent change||Standard Error|Mean
24073|NCT01700530|Primary|% Change in VO2max (Fitness)|% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max|Change from Baseline to 12 weeks|Statins blocked exercise induced change in fitness||percentage change of VO2max||Standard Deviation|Mean
24074|NCT01700517|Primary|Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block|"The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."|48 HOURS|This sample size was calculated for a fixed effects one-way analysis of variance design. It was assumed that the standard effect size (d) = 0.5, the level of alpha (two-tailed) = 0.05, and power = 0.8, resulting in twenty six patient. The sample was stratified, having 40 patients in each of three groups to compensate for expected dropouts||units on a scale||95% Confidence Interval|Mean
24095|NCT01700348|Primary|The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group|The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.|Four Months||||||
24096|NCT01700335|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 16 weeks||||||Number
24097|NCT01700335|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)|"Definition~Hematologic Improvement Erythrocyte (HI-E):~Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation~Hematologic Improvement Platelet (HI-P):~Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%~Hematologic Improvement Neutrophil (HI-N):~At least 100% increase and an absolute increase > 0.5×10^9/L~Progressive disease / Relapse:~At least 1 of the following:~At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 60 weeks|||participants|||Number
24098|NCT01700335|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)|"Definition~Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%~Partial remission (PR) Same as CR criteria except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%~Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR~Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 wks~Disease progression~Patients with:~Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts~Any of the following:~At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks|||participants|||Number
24099|NCT01700335|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 2. DLTs were also to be assessed in the Efficacy and Safety Assessment Committee.~Criteria:~Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)~Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 60 weeks|||participants|||Number
24100|NCT01700179|Primary|SVR12|To determine the incidence of a sustained virologic response at 12 weeks after the completion of dosing (SVR12) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification (<LOQ) at that time point|12 weeks following last dose|||percentage of subjects|||Number
24101|NCT01700140|Secondary|Skin Manifestations at Study Drug Application Site|"The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.~Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch)."|Up to 192 hours|"Skin manifestations were counted for each type of patch applied to the subjects in the safety population.~Placebo patch : 60-1+63+60=182 (One subject in placebo group did not applied 15 cm2 patch.)~SyB D-0701 15 cm2 patch : 62~SyB D-0701 25 cm2 patch : 62+63=125"||Number of events|||Number
24102|NCT01700140|Secondary|Severe (Grade 3 or More) Adverse Events|"The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.~Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE"|Up to 192 hours|"Safety population:~The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment."||Number of events|||Number
24103|NCT01700140|Secondary|Adverse Events|Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.|Up to 192 hours|"Safety population:~The safety population consisted of all subjects enrolled, except for subjects with Good Clinical Practice (GCP) non-compliance and those who failed to receive the study treatment."||Participants|||Number
24104|NCT01700140|Secondary|Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.~The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs."|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
24105|NCT01700140|Secondary|Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.~The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs."|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
24106|NCT01700140|Secondary|Time to First Nausea|Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Hours||95% Confidence Interval|Median
24107|NCT01700140|Secondary|Time to First Emesis|Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Hours||95% Confidence Interval|Median
24108|NCT01700140|Secondary|Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
24109|NCT01700140|Primary|Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."||Percentage of participants|||Number
24110|NCT01699867|Primary|Number of Margins With False Positive Device Readings||one week after surgery|Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.||False positive margins per patient||Standard Deviation|Mean
24111|NCT01699867|Primary|Patients With All Positive Margins Correctly Identified With the Device|"In this study, a patient had positive margins if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, tumor on ink)."|one week after surgery|"Patients with positive margins (0 mm, tumor on ink)."||Patients w/ all positives identified|||Number
24112|NCT01699815|Other Pre-specified|Average Length of Stay (LOS)|To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.|Baseline to discharge (1-4 days)|||days||Standard Deviation|Mean
24113|NCT01699815|Secondary|Pain Medication Consumption Rates|Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.|Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug|||participants|||Number
24114|NCT01699815|Primary|Changes in Postoperative Pain Scores|To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain|preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug|||units on a scale||Standard Deviation|Mean
24115|NCT01699789|Secondary|Park or Community Center Visits With Depression Service if Went to Park or Community Center||6 months follow-up|||percentage of participants||95% Confidence Interval|Mean
24116|NCT01699789|Secondary|Faith-based Visits With Depression Service if Faith Participation|For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.|6 months follow-up|||percentage of patients||95% Confidence Interval|Mean
24117|NCT01699789|Secondary|Medication Visits Among MHS Users||6 months follow-up|||percentage of participants||95% Confidence Interval|Mean
24118|NCT01699789|Secondary|>= 2 PCP Visits With Depression Services, if Any||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24119|NCT01699789|Secondary|>=2 Emergency Room Visits||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24120|NCT01699789|Secondary|>=4 Hospital Nights for Behavioral Health||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24121|NCT01699789|Secondary|Any Missed Work Day in Last 30 Days, if Working||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24122|NCT01699789|Secondary|Working for Pay||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24123|NCT01699789|Secondary|My Life is Organized||6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24124|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|12 months follow-up|||mean number of visits||95% Confidence Interval|Number
24125|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|6 months follow-up|||mean number of visits||95% Confidence Interval|Mean
24126|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
24127|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24128|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
24129|NCT01699789|Primary|PHQ-9 Score ≥ 10|Mild/moderate depression defined as PHQ-9 score ≥ 10.|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24130|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24131|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
24132|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24133|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
24134|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24135|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
24139|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|12 months follow-up|||percentage of participants||95% Confidence Interval|Number
24140|NCT01699789|Secondary|Homeless or ≥ 2 Risk Factors for Homelessness|Being homeless or having no place to stay for 2 nights or more; food insecurity; eviction from primary place of residence; or major financial crisis from items in client surveys. Homeless/shelter (pure, demo306=7) or >=2 risk factor for homelessness out of 4 items diff1 diff2 diff11 diff6)|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24141|NCT01699789|Secondary|Physically Active|Items on physical activity that are self-reported in the client survey, drawn from the SF-12 and measures of exercise and physical activity. how physically active you are (cond606>=3), 1=Quite/very/extreme active, %|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24142|NCT01699789|Secondary|Mental Wellness|Mental Wellness, % (at least good bit of time on 3 items on feeling peaceful or, calm, been a happy person, having energy), at least 1 item out of 3.|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24143|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|6 months follow-up|||percentage of participants||95% Confidence Interval|Number
24144|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with YSI plasma Blood Glucose (BG) >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (106) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 106 samples were greater than 180 mg/dL.||Percent Difference|Participants|Standard Error|Mean
24145|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)|"Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (107) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 107 samples were less than or equal to 80 mg/dL.||Percent Difference|Participants|Standard Error|Mean
24146|NCT01699763|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number 333 (336-3) BG results possible for each BGMS. Staff collected 3 capillary samples from each subject - total 336 samples. Three samples from one subject were not analyzed. Subject hematocrit (58.5) was above the study evaluable limit of 55.||Percent Difference|Participants|Standard Error|Mean
24147|NCT01699750|Secondary|Minimum Protected Area|Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||percentage of lens surface covered||Standard Deviation|Mean
24148|NCT01699750|Secondary|Average Exposure Speed|Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||percent of area exposed/second||Standard Deviation|Geometric Mean
24149|NCT01699750|Secondary|Overall Dryness Measured With Visual Analog Scale (VAS)|The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.||units on a scale||Standard Deviation|Mean
24150|NCT01699750|Secondary|Overall Comfort Measured With Visual Analog Scale (VAS)|The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.||units on a scale||Standard Deviation|Mean
24151|NCT01699750|Secondary|LogMAR Time-Controlled Visual Acuity (TCVA)|Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.||VA unit||Standard Deviation|Mean
24152|NCT01699750|Secondary|Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||seconds||Standard Deviation|Geometric Mean
24153|NCT01699750|Primary|Mean Ex-Vivo Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.||micrograms||Standard Deviation|Geometric Mean
24154|NCT01699698|Secondary|The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.|Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)|1 year|||participants|||Number
24155|NCT01699698|Primary|The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort|"We hypothesized that there is a statistically-significant difference between two cohorts.~The cancer marker is S100P."|1year|||pg/ml||Full Range|Median
24156|NCT01699685|Secondary|Airway Resistance (Raw)|Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||cmH2O/l/s||Standard Deviation|Mean
24157|NCT01699685|Secondary|Total Lung Capacity (TLC)|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
24158|NCT01699685|Secondary|Forced Volume Capacity (FVC)|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
24159|NCT01699685|Secondary|Inspiratory Capacity (IC)|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose|within 4h after dosing|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
24160|NCT01699685|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis||Liters||Standard Deviation|Mean
24161|NCT01699685|Primary|Inspiratory Capacity (IC) Peak Value|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis.||Liters||Standard Deviation|Mean
24162|NCT01699607|Primary|Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.|PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.|first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration|||percent change in binding potential||Standard Deviation|Mean
24175|NCT01698814|Primary|Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.|An average of 6 weeks|This reporting group includes all randomized subjects who received study medication.||participants|||Number
24176|NCT01698801|Secondary|Number of Participants With Adverse Events|An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.|From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
24177|NCT01698801|Secondary|Overall Survival (OS)|The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.||months||95% Confidence Interval|Median
24178|NCT01698801|Secondary|Progression Free Survival (PFS)|PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.||months||95% Confidence Interval|Median
24179|NCT01698801|Secondary|Duration of Response|Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.|From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug||months||95% Confidence Interval|Median
24180|NCT01698801|Secondary|Time to Response|"Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).~CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required."|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug||months||Full Range|Median
24181|NCT01698801|Primary|Overall Response Rate|"Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.~CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.||percentage of participants|||Number
24182|NCT01698684|Primary|Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing||Week 0 (Baseline) up to Week 8 (End of Study)|The intent-to-treat (ITT) population consists of all subjects who are randomized, take at least 1 dose of study medication, and have at least 1 post-dose efficacy assessment.||percentage of successes||Standard Deviation|Mean
24183|NCT01698554|Secondary|Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported."|Month 4|ITT Population included all randomized participants.||percentage of participants|||Number
24260|NCT01696994|Secondary|T1 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T1 were analyzed.||Participants|||Number
24184|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.||intensity units||Standard Deviation|Mean
24185|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.||mm^2||Standard Deviation|Mean
24186|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.||mm||Standard Deviation|Mean
24187|NCT01698554|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)|The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat (ITT) Population included all randomized participants.||percentage of participants|||Number
24188|NCT01698502|Secondary|The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).|Comparison of the total release of GIP during the 3 hour OGTT and IIGI.|Test day 1 and 2 within 7 days.|||pmol/L * 210 min||Standard Error|Mean
24189|NCT01698502|Primary|Incretin Effect (the % of Insulin Secreted Due to the Release of the Intestinal Hormones Glucagon Like Peptide-1 (GLP-1 and Glucose-dependent Insulinotropic Peptide (GIP))|The Incretin effect (the % of insulin secreted due to the release of the intestinal hormones GLP-1 and GIP) is calculated as the difference between the insulin concentration during a 3 hour oral glucose tolerance test (OGTT) (day 1) compared to a 3 hour isoglycemic intravenous glucose infusion (IIGI) (day 2) that has similar glucose excursions.|Test day 1 and 2 within 7 days.|||percentage||Standard Error|Mean
24190|NCT01698320|Primary|Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52|"The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.~HEENT = head, eyes, ears, nose, throat"|Weeks 0, 12 and 52|Safety population. Participants with assessments at each time point are reported.||participants|||Number
24191|NCT01698320|Primary|Change From Baseline in Pulse Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.~Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.||beats/minute||Standard Deviation|Mean
24192|NCT01698320|Primary|Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.~Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.||mmHg||Standard Deviation|Mean
24193|NCT01698320|Primary|Electrocardiogram (ECG) Results At Weeks 0, 12, and 52|A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.|Weeks 0 (screening visit), 12, and 52|Safety population. Participants with assessments at each time point are reported.||participants|||Number
24194|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Weeks 13-52|Safety population||participants|||Number
24195|NCT01698320|Other Pre-specified|Daily AM Peak Expiratory Flow (PEF) to Week 52|Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.|Baseline to Week 52||||||
24196|NCT01698320|Other Pre-specified|Device Invitro Evaluations to Week 52|"Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:~Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing~Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing"|Baseline to Week 52||||||
24197|NCT01698320|Other Pre-specified|Composite Measurement of Device Ruggedness From Baseline to Week 52|Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).|Baseline to Week 52||||||
24261|NCT01696994|Secondary|T1 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T1 were analyzed.||Participants|||Number
24198|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population||participants|||Number
24199|NCT01697969|Primary|Patient-Assessed Ocular Itching|The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.|Baseline (Day 1), Day 14|The analysis population includes all participants exposed to the test product. Here, “n” is the number of participants with non-missing values at the specific time point.||units on a scale||Standard Deviation|Mean
24200|NCT01697956|Secondary|Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population||participants|||Number
24201|NCT01697956|Secondary|Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population||participants|||Number
24202|NCT01697956|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities).~The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out).~An SAE was defined as an AE that resulted in any of the following:~Death~Life-threatening~Required hospitalization or prolonged existing hospitalization~Persistent or significant disability or incapacity~A congenital abnormality or birth defect~An important medical event which required medical intervention to prevent any of the above outcomes."|Day 1- week 10|Safety population which included all randomized participants who received at least one dose of randomized study medication.||participants|||Number
24203|NCT01697956|Secondary|Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, t1/2 for BDP could not be estimated for any participants.||hours||Standard Deviation|Mean
24204|NCT01697956|Secondary|Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, λz for BDP could not be estimated for any participants.||1/hour||Standard Deviation|Mean
24205|NCT01697956|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.||hours||Standard Deviation|Mean
24206|NCT01697956|Secondary|Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day.||pg/mL||Standard Deviation|Mean
24255|NCT01696994|Primary|Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
24207|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.||h*pg/mL||Standard Deviation|Mean
24208|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day||h*pg/mL||Standard Deviation|Mean
24209|NCT01697956|Primary|Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment|The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.|Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)|Per protocol (PP) population||ratio||Standard Error|Geometric Mean
24210|NCT01697696|Secondary|Time to First COPD Exacerbation (Moderate or Severe).|COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required. Rates are calculated using the Kaplan Meier method.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized||Days||95% Confidence Interval|Median
24211|NCT01697696|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded by the patients in the eDiary in the morning and evening. The total number of puffs of rescue medication per day over the 52 week treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator. Change from baseline in number of puffs were analyzed using a linear mixed model which contained treatment, baseline number of puffs, baseline smoking status, baseline ICS use and COPD disease severity as fixed effects with center as a random effect|52 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Number of puffs||Standard Error|Least Squares Mean
24212|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|Percentage of days with ‘no daytime symptoms’ A day with ‘no daytime symptoms’ was defined from the diary data as any day where the patient had recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) and no puffs of rescue medication during the past 12 hours (approximately 8 am to 8pm). However, a patient was not considered symptom free if they had used rescue medication that day even if his/her total daytime symptoms score was zero. Percentage of nights with ‘no nighttime awakenings’ A night with ‘no nighttime awakenings’ was defined from diary data as any night where the patient did not wake up due to symptoms. The total number of nights with ‘no nighttime awakenings’ over the treatment period was divided by the total number of nights where diary recordings had been made in order to derive the percentage nights with ‘no nighttime awakenings’.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Percentage of days / nights||Standard Error|Least Squares Mean
24213|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|The total symptom score was defined as the sum of individual cores for respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and reathlessness. Where a patient had a morning score and an evening score for an individual symptom on one particular day then the worst score was to be taken as the daily score for that symptom. Each symptom scale ranged from 0-3 where 0 was no symptoms and 3 was the worst. The total daily/daytime/nighttime symptom score consists of looking at the score for 6 symptoms and can therefore have a minimum score of 0 or a maximum of 18.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.”||scores on a scale||Standard Error|Least Squares Mean
24214|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.||Liters||Standard Deviation|Mean
24256|NCT01696994|Secondary|T3 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T3 were analyzed.||Participants|||Number
24257|NCT01696994|Secondary|T3 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T3 were analyzed.||Participants|||Number
24215|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS). At each day/time point, only subjects with a value at both baseline and the respective day/time point are included. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.||Liters||Standard Deviation|Mean
24216|NCT01697696|Secondary|Change From Baseline in Mean Forced Expiratory Volume (Average of the Two FEV1 Measurements 45 and 15 Minutes Pre-dose) in One Second at Week 52|Change from baseline in pre-dose trough FEV1 was analyzed using a repeated measures analysis of covariance model which contained treatment, baseline FEV1, visit, baseline smoking status, baseline ICS use, COPD severity and treatment by visit, visit by baseline FEV1 interactions. An unstructured variance-covariance error matrix was used .Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose at Week 52. Baseline FEV1 was defined as the mean of the pre-dose FEV1 at -45 min and -15 min on Day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS) included patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
24217|NCT01697696|Secondary|Time to Treatment Discontinuation|Discontinuation rates are calculated using the Kaplan Meier method. The protocol allowed patients to discontinue outside the treatment window, hence we have a patient who discontinued at Day 388. Reasons for discontinuing treatment are Subject/guardian decision, Adverse event, Protocol deviation Lack of efficacy, Physician decision, Dosing error, Disease improvement under study, Pregnancy, Technical problems|52 Weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
24218|NCT01697696|Primary|Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis||Percentage of participants|||Number
24219|NCT01697592|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.|Baseline and Week 24|Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.||Percent HbA1C||95% Confidence Interval|Least Squares Mean
24220|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.||Percentage of participants|||Number
24221|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of Participants|||Number
24222|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.||Percentage of participants|||Number
24223|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).|Up to 24 weeks|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of participants|||Number
24224|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS||percentage of participants|||Number
24225|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
24226|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS||percentage of participants|||Number
24227|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
24228|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT||EoT|FAS||percentage of participants|||Number
24229|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)||EoT, as defined in the predecessor study, was at Week 48 or Week 96|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
24230|NCT01697501|Primary|Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF||EoF|FAS||percentage of participants|||Number
24231|NCT01697501|Primary|Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)||EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.|Full analysis set (FAS), defined as all subjects who completed||percentage of participants|||Number
24232|NCT01697462|Secondary|Number of Participants With Hand-Foot Syndrome (HFS)|HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.|Baseline up to end of study (up to 42 months)|ITT population.||Participants|||Number
24233|NCT01697462|Secondary|Progression-Free Survival (PFS)|PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.||Months||95% Confidence Interval|Median
24234|NCT01697462|Secondary|Percentage of Participants With Disease Progression|Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.||Percentage of participants|||Number
24235|NCT01697462|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.|Baseline up to end of study (up to 42 months)|Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.||Participants|||Number
24236|NCT01697449|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.||months||95% Confidence Interval|Median
24237|NCT01697449|Secondary|Percentage of Participants With Disease Progression or Death|Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.||percentage of participants|||Number
24238|NCT01697449|Secondary|Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline||Up to 65 months|Included participants whose CRC was identified as unresectable at baseline.||percentage of participants|||Number
24258|NCT01696994|Secondary|T2 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T2 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T2 were analyzed.||Participants|||Number
24259|NCT01696994|Secondary|T2 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T2 (two years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T2 were analyzed.||Participants|||Number
31080|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough IC on Day 7|Change from baseline in morning pre-dose trough IC|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
24239|NCT01697449|Secondary|Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)|Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|All participants who received at least 1 dose of study drug were included in this analysis.||percentage of participants|||Number
24240|NCT01697449|Primary|Percentage of Participants With At Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 65 months|All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis.||percentage of participants|||Number
24241|NCT01697345|Secondary|Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study||After 4 weeks|||participants|||Number
24242|NCT01697345|Primary|FSFI Pain Domain|The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
24243|NCT01697345|Primary|FSFI Satisfaction Domain|The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
24244|NCT01697345|Primary|FSFI Orgasm Domain|The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
24245|NCT01697345|Primary|FSFI Lubrication Domain|The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
24246|NCT01697345|Primary|FSFI Arousal Domain|The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
24247|NCT01697345|Primary|FSFI Desire Domain|The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
24248|NCT01697345|Primary|Total Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction.|Baseline, 4 weeks|||units on a scale||Standard Deviation|Mean
24249|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Timed 25-Foot Walk Test (25FWT)|The timed 25-Foot Walk Test (25FWT) is an assessment of mobility and performance of leg function. The patient was instructed to walk a marked 25-foot course as quickly as possible in a time limit of 3 minutes and immediately walk back the same distance when reaching one end.The patient is allowed to use any ambulation method to move. The outcome measures the speed (feet / min) of moving.|Up to 96 weeks|Modified ITT Population||% of change||Standard Deviation|Mean
24250|NCT01697319|Primary|Change From Baseline in Strength as Assessed by Grip and Pinch Test (GPT)|A grip-strength dynamometer and a pinch meter were used to measure grip strength and pinch strength. The results report change from baseline in strength for dominant and non-dominant hand in a forearm and wrist supported position.|Up to 96 weeks|Modified ITT Population||kg||Standard Deviation|Mean
24251|NCT01697319|Secondary|Percent Change From Baseline in Normalized Urine Keratan Sulfate (uKS)|Urinary keratan sulfate and urinary creatinine were measured through quantitative analysis. uKS is normalized to creatinine.|Up to 96 weeks|Modified ITT Population||% of change||Standard Deviation|Mean
24252|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Functional Dexterity Test (FDT)|FDT assesses the ability to use the hand in daily tasks. The test involves turning 16 wooden pegs over as quickly as possible on a hardwood pegboard with one hand requiring a three-jaw chuck prehension pattern between the fingers and thumb within a two-minute time limit. Hand function is evaluated by how fast a patient can turn over pegs in the given time limit, i.e. speed (number of pegs/minute).|Up to 96 weeks|Modified ITT Population||% of change||Standard Deviation|Mean
24253|NCT01696994|Secondary|T5 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T5 (five years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T5 were analyzed.||Participants|||Number
24254|NCT01696994|Secondary|T4 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T4 (four years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T4 were analyzed.||Participants|||Number
24262|NCT01696994|Secondary|T0 (Baseline) TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T0 were analyzed.||Participants|||Number
24263|NCT01696994|Secondary|T0 (Baseline) CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T0 were analyzed.||Participants|||Number
24264|NCT01696994|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, she would be counted 3 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
24265|NCT01696994|Secondary|Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).|Ovarian cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as ovarian cancer diagnoses divided by person years at risk for ovarian cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
24266|NCT01696994|Secondary|Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
24267|NCT01696994|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
24268|NCT01696994|Secondary|Deaths From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|||Participants|||Number
24269|NCT01696994|Primary|Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|||Participants|||Number
24270|NCT01696981|Secondary|T3/T5 FSG Screening Result|Flexible sigmoidoscopy (FSG) result|T3 (three years after entry) or T5 (five years after entry)|All participants in the Colorectal Screening arm who had an FSG at T0 or T3 were analyzed.||Participants|||Number
24271|NCT01696981|Secondary|T0 (Baseline) FSG Screening Results|Flexible sigmoidoscopy (FSG) result|T0 (at study entry)|All participants in the Colorectal Screening arm who had an FSG at T0 were analyzed.||Participants|||Number
24272|NCT01696981|Primary|Colorectal Cancer Death Rates|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|||Deaths per 10,000 PY|||Number
24273|NCT01696981|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 2 positive screens with documented follow-up after each one, he would be counted 2 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
24274|NCT01696981|Secondary|Colorectal Cancer Incidence Rates|Colorectal cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as colorectal cancer diagnoses divided by person years at risk for colorectal cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
24275|NCT01696981|Secondary|Colorectal Cancer Incidence|Colorectal cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Participants|||Number
24276|NCT01696981|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
24277|NCT01696981|Secondary|Deaths From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.||Participants|||Number
24278|NCT01696981|Primary|Colorectal Cancer Deaths|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|||Participants|||Number
24279|NCT01696968|Secondary|T3 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T3 (three years after entry)|All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.||Participants|||Number
24280|NCT01696968|Secondary|T2 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T2 (two years after entry)|All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.||Participants|||Number
24281|NCT01696968|Primary|Lung Cancer Death Rates|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|||Deaths per 10,000 PY|||Number
31081|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Day 7|Peak change from baseline in FEV1 Day 7|Day 7|MITT||Millliters||95% Confidence Interval|Least Squares Mean
24284|NCT01696968|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of positive screens with complications.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
24285|NCT01696968|Secondary|Lung Cancer Incidence Rates|Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
24286|NCT01696968|Secondary|Lung Cancer Incidence|Lung cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
24287|NCT01696968|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
24288|NCT01696968|Secondary|Deaths From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
24289|NCT01696968|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
24290|NCT01696929|Secondary|Change in Total Psychotic Symptoms|The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology.|Change in PANSS total score from baseline to 8 weeks|||Change in PANSS Total Score||Standard Deviation|Mean
24291|NCT01696929|Primary|Change in Cognition|The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108–115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline.|Change in BACS composite score from baseline to 8 weeks|||Change in BACS Composite Score||Standard Deviation|Mean
24292|NCT01696773|Primary|Pharmacokinetics of Carotenoid Absorption|The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.|11 post-prandial blood samples will be taken over 12 hours|||nmol*h/L||Standard Error|Mean
24293|NCT01696760|Secondary|Death Rate||Up to 3 months|||participants|||Number
24294|NCT01696760|Secondary|Excessive Wound Drainage||Up to 3 months|||participants|||Number
24295|NCT01696760|Secondary|Hematoma Formation||Up to 3 months|||participants|||Number
24296|NCT01696760|Secondary|Readmission Rate to Hopsital||Up to 3 months|||participants|||Number
24297|NCT01696760|Secondary|Development of Other Complications (Including Bleeding Complications)||Up to 3 months|||participants|||Number
24298|NCT01696760|Secondary|Pulmonary Embolism Rate||Up to 3 months|||participants|||Number
24299|NCT01696760|Primary|DVT Incident Rate|This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p < 0.05.|Up to 3 months|||participants|||Number
24300|NCT01696695|Secondary|Percentage of Participants With Dose Modification of Capecitabine||Baseline up to 1254 days|ITT Population.||Percentage of participants|||Number
24301|NCT01696695|Secondary|Mean Duration of Capecitabine Therapy||Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.||Days||Standard Deviation|Mean
24302|NCT01696695|Secondary|Percentage of Participants Who Underwent Metastasectomy|Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.|Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
24342|NCT01696058|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables||Area Under the Curve (L) (standardized)||Standard Error|Least Squares Mean
24303|NCT01696695|Secondary|Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1|Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population.||Percentage of participants||95% Confidence Interval|Number
24304|NCT01696695|Secondary|Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1|Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT population.||Percentage of participants||95% Confidence Interval|Number
24305|NCT01696695|Primary|PFS by Therapeutic Regimens|PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population. Here, number (n)= number of participants evaluable for the specified therapeutic regimen.||Days||95% Confidence Interval|Median
24306|NCT01696695|Primary|Median Progression-free Survival (PFS)|PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population||Days||95% Confidence Interval|Median
24307|NCT01696643|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, CV accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for the serious adverse events of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal (OW) events of interest included opioid withdrawal syndrome. The adverse events that indicated central OW included, but were not limited to, hyperhidrosis, tremor, dysphoria, and myalgia.~The number of participants with at least 1 confirmed CV, GI, or Central OW event is presented."|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||participants|||Number
24308|NCT01696643|Secondary|Plasma Trough Concentrations of CB-5945|Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks.|Weeks 4, 12, 24, 36, and 52|All participants randomized to CB-5945 who received at least 1 dose of study drug and had evaluable CB-5945 concentration data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
24309|NCT01696643|Secondary|Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52|The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PCSA data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||units on a scale||Standard Deviation|Mean
24322|NCT01696071|Secondary|Trough FVC Responses|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FVC was defined as the FVC value just prior to the last evening dose of study medication.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24310|NCT01696643|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52|The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PAC-QOL data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||units on a scale||Standard Deviation|Mean
24311|NCT01696643|Secondary|Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52|Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized.|Baseline, Weeks 49-52|All randomized participants who received at least 1 dose of study drug and had evaluable METDD data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||milligrams of METDD||Standard Deviation|Mean
24312|NCT01696643|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included “possibly related” or “related” as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.||percentage of participants|||Number
24313|NCT01696357|Primary|Average Number of Coughs Per Hour|The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.|7 days|One subject in the non-asthma group failed to return the device after the 7-trial. Data from 22 participants (3 from the asthma group, 19 from non-asthma group) were not included in the analysis as no data were recorded (due to a mechanical issue) or data were too extreme (due to cough algorithm failure).||average number of coughs per hour||Standard Deviation|Mean
24314|NCT01696214|Secondary|Physiologic Measures Were Determined at the Initial Visit, at Randomization Following a wash-in Period of 1 Month, Monthly for 24 Weeks and0 That a Follow-up Visit 1 Month Off Study Drug. Mean Scores Over the 24 Weeks of Treatment Were Compared.|Physiologic measures of FEV1, FVC and FEV1/FVC ratio|At each visit||||||
24315|NCT01696214|Secondary|The Asthma Symptom Utility Index(AUSI)|The Asthma Symptom Utility Index (AUSI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics.|Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatmen||||||
24316|NCT01696214|Primary|Asthma Control Test|The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.|Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatment were compared.|||units on a scale||Full Range|Median
24317|NCT01696188|Secondary|Time for Block Placement|Calculate the time to perform the nerve block procedure.|immediately post-procedure|||seconds||95% Confidence Interval|Mean
24318|NCT01696188|Secondary|Opioid Consumption|Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV|48 hours|||mg IV morphine equivalents||Inter-Quartile Range|Median
24319|NCT01696188|Secondary|Catheter Dislodgements|Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.|24 hours|||participants|||Number
24320|NCT01696188|Primary|Visual Analog Scale Pain Scores|Pain was rated from 0 (no pain) to 10 (worst pain imaginable)|24 hours|||units on a scale||Inter-Quartile Range|Median
24321|NCT01696071|Secondary|Peak Expiratory Flow (PEF) AUC0-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres per minute.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres/min||Standard Error|Least Squares Mean
24323|NCT01696071|Secondary|Peak FVC Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FVC was defined as the highest FVC reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FVC Peak0-24h).|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24324|NCT01696071|Secondary|FVC AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24325|NCT01696071|Secondary|FVC AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24326|NCT01696071|Secondary|Forced Vital Capacity (FVC) AUC0-24h Response|"MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.~The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24327|NCT01696071|Secondary|Trough FEV1 (L) Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FEV1 was defined as the FEV1 value just prior to the last evening dose of study medication.|10 minutes (min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24328|NCT01696071|Secondary|Peak FEV1 Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FEV1 was defined as the highest FEV1 reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FEV1 Peak0-24h). The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively.|10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks.|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24329|NCT01696071|Secondary|FEV1 AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24330|NCT01696071|Secondary|FEV1 AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Litres||Standard Error|Least Squares Mean
24341|NCT01696058|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24331|NCT01696071|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response.|"Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.~The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.||Liters||Standard Error|Least Squares Mean
24332|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|"Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||number of puffs||Standard Error|Least Squares Mean
24333|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|"Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||number of puffs||Standard Error|Least Squares Mean
24334|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|"Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol metered dose inhaler (MDI) (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||usage (total daily) number of puffs||Standard Error|Least Squares Mean
24335|NCT01696058|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|"Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
24336|NCT01696058|Secondary|Trough FVC Response at 12 Weeks; Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||L||Standard Error|Least Squares Mean
24337|NCT01696058|Secondary|Peak FVC Response at 12 Weeks; Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24338|NCT01696058|Secondary|FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline. AUC was standardized by dividing by time unit.|baseline and 12 Weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24339|NCT01696058|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as change from baseline. All p-values for these measures are only descriptive.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24340|NCT01696058|Secondary|Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data|The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores [dichotomous (true/false) except last question (4-point Likert scale)]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate – study – will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.|12 weeks|FAS with last observation carried forward (LOCF) imputation (combined data from twin studies 1222.51 and 1222.52). Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039).||units on a scale (total score)||Standard Error|Least Squares Mean
24344|NCT01695772|Secondary|Disease Free Survival (DFS)|Disease Free Survival (DFS) was defined as the time from complete resection of liver metastases to disease relapse or death, for participants who achieve complete resection after pre-operative treatment with standard 5-FU based doublet regimen plus bevacizumab.|Complete resection date up to disease relapse or death until data cutoff on 04 April 2015 (up to approximately 2.5 years)|ITT population; Here, number of participants analyzed = participants who underwent study specified surgery. Participants who underwent surgery but did not achieve complete resection were censored.||months||95% Confidence Interval|Median
24345|NCT01695772|Secondary|Percentage of Participants With Disease Relapse or Death||Screening until disease progression or death until data cutoff on 04 April 2015 (up to approximately 2.5 years overall)|ITT population||percentage of participants|||Number
24346|NCT01695772|Secondary|Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. The probability was estimated by Kaplan Meier curve analysis.|Months 3, 6, 9, 12, 15, and 18|ITT population; Number of participants analyzed equals (=) number of participants who had surgery.||PP of being alive and progression free||95% Confidence Interval|Number
24347|NCT01695772|Secondary|Progression Free Survival (PFS)|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. Kaplan-Meier curves were used to display PFS.|Screening until disease progression or death until data cutoff on 04 April 2015 (up to approximately 2.5 years overall)|ITT population||months||95% Confidence Interval|Median
24348|NCT01695772|Secondary|Percentage of Participants With Disease Progression or Relapse or Death|According to RECIST v1.1 Progressive Disease is defined as a 20 % or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions.|Screening until disease progression or death until data cutoff on 04 April 2015 (up to approximately 2.5 years overall)|ITT population||percentage of participants|||Number
24349|NCT01695772|Secondary|Percentage of Participants Achieving Objective Response|Objective response rate was defined as the percentage of participants who achieved either Partial Response (PR) or Complete Response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1. This is defined as the best response recorded from the start of trial treatment until disease progression (or death). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [≥] 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Screening until disease progression or death until data cutoff on 04 April 2015 (up to approximately 2.5 years overall)|ITT population||percentage of participants||95% Confidence Interval|Number
24350|NCT01695772|Secondary|Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection)|R1 resection was defined as achievement of incomplete tumor resection with microscopic involvement of a margin after pre-operative chemotherapy plus bevacizumab, as confirmed by pathology. Participants with R1 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population||percentage of participants||95% Confidence Interval|Number
24351|NCT01695772|Primary|Percentage of Participants Achieving Complete Resection (R0 Resection)|R0 resection was defined as complete resection confirmed by pathology after pre-operative chemotherapy plus bevacizumab. Participants with R0 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population||percentage of participants||95% Confidence Interval|Number
24352|NCT01695746|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 24|The safety population was defined as all participants entered into the study.||Participants|||Number
24353|NCT01695746|Secondary|Number of Participants Who Received Concomitant Treatment for Anemia|Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.|Up to Week 24|The safety population included all participants entered into the study.||Participants|||Number
24354|NCT01695746|Primary|Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value|Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.|Up to Week 24|The ITT population was the anticipated population for analysis.|||||
24355|NCT01695746|Primary|Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)|Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time – visit date of first dosing) + 1.|Up to Week 24|The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.||Weeks||Standard Deviation|Mean
24356|NCT01695746|Primary|Number of Participants With Co-morbidities at Baseline (Week 0)|Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.||Participants|||Number
24357|NCT01695746|Secondary|Number of Doses of C.E.R.A. Administered by Different Routes|The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.|Up to Week 24|The safety population included all participants entered into the study.||Doses|||Number
24358|NCT01695746|Secondary|Mean Dose of C.E.R.A. Administered|The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.|Up to Week 24|The safety population included all participants entered into the study.||mcg per month||Standard Deviation|Mean
24359|NCT01695746|Secondary|Mean Time Spent in the Hemoglobin Target Range (10 – 12 Gram/Deciliter)|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 – 12 g/dL) is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.||Weeks||Standard Deviation|Mean
24360|NCT01695746|Secondary|Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study|Correction of anemia was evaluated in participants with Hb < 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation.||Percentage of participants|||Number
24361|NCT01695746|Primary|Mean Weight of Participants at Baseline (Week 0)|The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.||kg||Standard Deviation|Mean
24362|NCT01695746|Primary|Mean Height of Participants at Baseline (Week 0)|The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.||cm||Standard Deviation|Mean
24363|NCT01695668|Primary|Progression of Dry Eye Severity|Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.|1 year|||patients with increased dry eye severity|||Number
24364|NCT01695369|Primary|Subjective Responses for Comfort Rated on a 0-100 Visual Scale.|Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)|Baseline Insertion, 10 Minutes, 5 hours and 10 hours|||units on a scale||Standard Deviation|Mean
24365|NCT01695330|Secondary|Compare Overall Response Rate (CR + VGPR + PR + MR), Compare Disease Parameters, & Determine Incidence and Severity of Injection-site Reactions.|Compare overall response rate [combined CR + very good partial response (VGPR) + PR + MR] and disease parameters [time to progression, -progression free survival, -time to first response, -duration of response, -overall survival] following treatment with a SC bortezomib-containing combination regimen for MM patients who have demonstrated progressive disease form a prior or different IV bortezomib-containing combination regimen. Determine incidence and severity of injection-site reactions with CS administration of bortezomib by number of patients with injection site reaction specific adverse events.|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.||10/2017||||
24366|NCT01695330|Primary|The Primary Objective of This Study Will be to Investigate the Incidence and Severity of Peripheral Neuropathy Caused by a Prior Intravenous VELCADE-containing Regimen in Comparison to That Caused by a Subcutaneous VELCADE-containing Regimen.|"Definition of incidence: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit.~Definition of severity: the severity of any treatment-emergent peripheral neuropathy experienced by a patient on-study. Peripheral neuropathy severity is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as the End of Study visit and is graded on a 0-4 scale based on CTCAE criteria.~Incidence of Peripheral Neuropathy Definition: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit."|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.|||Participants|||Count of Participants
24393|NCT01694771|Secondary|Trough FVC Response at 12 Weeks- Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||L||Standard Error|Least Squares Mean
24367|NCT01695239|Secondary|Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)|Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.|Baseline to Week 24|All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and postbaseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.||participants|||Number
24368|NCT01695239|Secondary|Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score.||units on a scale||Standard Error|Least Squares Mean
24369|NCT01695239|Secondary|Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)|The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.||units on a scale||Standard Error|Least Squares Mean
24370|NCT01695239|Secondary|Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.||units on a scale||Standard Error|Least Squares Mean
24371|NCT01695239|Secondary|Percent Change From Baseline in Body Surface Area (BSA)|The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant’s handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.||percent change in BSA||Standard Error|Least Squares Mean
24372|NCT01695239|Secondary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline|The sPGA is the physician’s determination of the severity of the participant’s psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.|Week 24|All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
24373|NCT01695239|Secondary|Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)|The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
24374|NCT01695239|Secondary|Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease|The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant’s Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.|Baseline, Week 24|All randomized participants who had baseline and post baseline DAS28-CRP data.||units on a scale||Standard Error|Least Squares Mean
24463|NCT01693185|Secondary|Participants Assumed to Feel Frequent Pain|"patients sound Ah at feeling pain during colonosocpy: if a patients sounds Ah > 6 times, the patient was assumed to feel frequent pain."|during and after colonoscopy|||participants|||Number
24375|NCT01695239|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])|The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline QIDS-SR16 data.||units on a scale||Standard Error|Least Squares Mean
24376|NCT01695239|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.||units on a scale||Standard Error|Least Squares Mean
24377|NCT01695239|Secondary|Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)|JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.|Baseline, Week 24|All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.||units on a scale||Standard Error|Least Squares Mean
24378|NCT01695239|Secondary|Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no fatigue” and 10 representing “as bad as you can imagine.” Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline fatigue NRS data.||units on a scale||Standard Error|Least Squares Mean
24379|NCT01695239|Secondary|Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 12|All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.||units on a scale||Standard Error|Least Squares Mean
24380|NCT01695239|Secondary|Change From Baseline in Leeds Enthesitis Index (LEI)|The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 12|All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.||units on a scale||Standard Error|Least Squares Mean
24381|NCT01695239|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)|The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
24382|NCT01695239|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])|The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline mTSS data.||units on a scale||Standard Error|Least Squares Mean
24383|NCT01695239|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant’s self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline HAQ-DI data.||units on a scale||Standard Error|Least Squares Mean
24384|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score at Week 24|ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
24385|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24|ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
24386|NCT01695239|Secondary|Percentage of Participants Achieving ACR20 Response at Week 12|ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 12|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
24387|NCT01695239|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).|Week 24|All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.||percentage of participants|||Number
24388|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
24389|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
24390|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||usage (total daily) number of puffs||Standard Error|Least Squares Mean
24391|NCT01694771|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation||percentage of days||Standard Error|Least Squares Mean
24392|NCT01694771|Secondary|Peak FVC Response at 12 Weeks - Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24394|NCT01694771|Secondary|FVC AUC0-3h Response at 12 Weeks - Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24395|NCT01694771|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24396|NCT01694771|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.||L||Standard Error|Least Squares Mean
24397|NCT01694771|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables||Area Under the Curve (L)||Standard Error|Least Squares Mean
24398|NCT01694706|Secondary|Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
24399|NCT01694706|Primary|Faldaprevir: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the faldaprevir in plasma~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
24400|NCT01694706|Primary|Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|Pharmacokinetic (PK) set: Included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
24401|NCT01694667|Secondary|Change in Clinical Global Impression - Improvement (CGI-I) Score|"Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who responded in each group is the number where the parents reported that their child was improved, much improved, or very much improved."|Baseline, Week 6|||# parents reporting improvement|||Number
24402|NCT01694667|Secondary|Change in Social Responsiveness Scale (SRS) Score|Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.|Baseline, Week 6||||||
24403|NCT01694667|Secondary|Aberrant Behavior Checklist - Inappropriate Speech Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
24404|NCT01694667|Secondary|Aberrant Behavior Checklist - Irritability Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
24405|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Stereotypy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
24406|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Lethargy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48."|Baseline, Week 6|||units on a scale||Standard Deviation|Mean
24479|NCT01692340|Secondary|Carotenoid Metabolites|Study the metabolites produced from the labeled carotenoid in healthy subjects|Up to 28 days|Due to funding issues, at present we have not analyzed these samples for carotenoid metabolites.|||||
24407|NCT01694667|Primary|Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48."|Baseline, 6 weeks (3 week value to be collected)|||units on a scale||Standard Deviation|Mean
24408|NCT01694641|Other Pre-specified|Perinatal Outcome|gestational age at delivery, birth weight,|perinatal outcome assessed after delivery||||||
24409|NCT01694641|Other Pre-specified|Time Lapse Score|a score based on 8 observations by time lapse monitoring|the time lapse score is assessed on the day of embryo transfer (day 5 after the egg retrieval)||||||
24410|NCT01694641|Secondary|Clinical Pregnancy|intrauterine sac plus embryo with heartbeat at 8 weeks gestation|at 8 weeks gestation||||||
24411|NCT01694641|Primary|Pregnancy Rate|rise in beta HCG 12-14 days after transfer|12-14 days after transfer|All patients randomized are analyszs (intention to treat analysis).||Participants|||Count of Participants
24412|NCT01694420|Other Pre-specified|Number of Participants With Adverse Events Related to Study Drug||48 weeks|||participants|||Number
24413|NCT01694420|Other Pre-specified|Number of Participants With Grade 3 or Grade 4 Adverse Events||48 weeks|||participants|||Number
24414|NCT01694420|Secondary|Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF||48 weeks|||days||Full Range|Median
24415|NCT01694420|Secondary|Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+||48 weeks|Data not collected|||||
24416|NCT01694420|Primary|Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48||48 weeks|||participants|||Number
24417|NCT01694420|Primary|Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24||24 weeks|||participants|||Number
24418|NCT01694108|Other Pre-specified|Quality of Communication and Information|"To test that the use of telephone and internet was acceptable in the study population using the Quality of Informed Consent (QuIC) questionnaire. The questionnaire was divided into six categories; five on study comprehension and one on satisfaction with the information process. The items in the first five categories could be answered with yes, no or do not know. The last category was rated on a 7-point Likert scale, with 1 being “very dissatisfied” and 7 being “very satisfied”. The primary outcome was the sum of the score for comprehension items and satisfaction items. Comprehension items were scored 1 point for each correct answer and 0 points for each incorrect answer. Satisfaction items were scored as rated on the 7-point Likert scale. Total score ranged from 7 to 69 points, comprehension score from 0 to 20 points and satisfaction score from 7 to 49 points. The higher score, the better comprehension and satisfaction."|2 days after the information was given|This is a small, separate sub-study. 59 + 59 participants had sufficient follow-up data to participate in the analysis.||Score on QuIC scale||Inter-Quartile Range|Mean
24419|NCT01694108|Other Pre-specified|Decisional Conflict Scale Score|After parents having made the decision about whether to accept vaccination of their newborn through participation in The Danish Calmette Study, O’Connor’s Decisional Conflict Scale was used to identify decisional conflicts. The score ranges from 0 (no decisional conflict) til 100 (maximum decisional conflict). Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation; so a low score reflects a low level of doubt about the decision about participation/decline participation in the trial, and a high score reflects a high level of doubt.|The decisional conflict score was measured before randomisation|This outcome was a sub-study to The Danish Calmette Study with 667 participating mothers and 320 declining mothers.||decisional conflict score||Inter-Quartile Range|Mean
24420|NCT01694108|Secondary|Number of Events of Febrile Convulsions|To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
24421|NCT01694108|Secondary|Number of Events of Acute Otitis Media|To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
24422|NCT01694108|Secondary|Number of Events With Diarrhoea and Vomiting|To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
24423|NCT01694108|Secondary|Number of Events of Febrile Episodes|To test that Danish infants who get the BCG vaccine at birth get less febrile episodes at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
24424|NCT01694108|Secondary|Number of Events of Pneumonia|To test that Danish infants who get the BCG vaccine at birth get less pneumonia at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
24425|NCT01694108|Secondary|Number of Events of Common Cold|To test that Danish infants who get the BCG vaccine at birth experience less events of common cold until 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Events|||Number
24426|NCT01694108|Secondary|Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL|To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.|13 months of age|This outcome was a sub-study with 158 participants. Antibody concentration (AC) of > 0.1 IU/mL was considered protective||participants|||Number
24427|NCT01694108|Secondary|Interferon Gamma Response|To test that infants who receive the BCG at birth respond in interferon-gamma response upon stimulation with BCG. The interferon gamma response was defined as a value above the cut-off value of 107 pg/ml.|13 months of age|This is a sub study using bloodsamples. Only a small sub population from the overall trial participated.||participants|||Number
24428|NCT01694108|Secondary|Monocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in monocyte count measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.||Cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
24429|NCT01694108|Secondary|Leucocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in leucocyte count (white blood cell count) measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.||cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
24430|NCT01694108|Secondary|Thymic Gland Size at 3 Months of Age|To test that infants who receive the BCG at birth respond in thymic gland size defined by ultra sound examination. First, the thymus gland was identified in a horizontal scanning plane and the largest transverse diameter of the thymus was obtained. Second, in a sagittal scanning plane, the area of the largest lobe was assessed. Both measurements were obtained twice, and in case of more than 15% difference, both measurements were repeated. The mean of the two measurements were multiplied and defined as the thymic index.|3 months of age|This outcome was a sub-study to The Danish Calmette Study with 301 (BCG 153, Control 148) participating children.||Thymic index||95% Confidence Interval|Mean
24431|NCT01694108|Secondary|Standardized Head Circumference at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in head circumference. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Head circumference z-score||Standard Deviation|Mean
24432|NCT01694108|Secondary|Length at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in length. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.||Length z-score||Standard Deviation|Mean
24433|NCT01694108|Secondary|Food Allergy|Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.||participants|||Number
24434|NCT01694108|Secondary|Episodic Viral Wheeze|Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview.|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.||participants|||Number
24435|NCT01694108|Secondary|Standardized Weight, Length and Head Circumference of Premature Children at 13 Months|The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|Premature children born with gestational age 32-36 weeks. This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.||z-score||Standard Deviation|Mean
24436|NCT01694108|Secondary|DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age|To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.|13 months of age|Per-protocol analysis excluding 11 children randomised to BCG who did not receive the vaccine, and 36 children randomised to control who received the BCG vaccine.||participants|||Number
24437|NCT01694108|Secondary|Psychomotor Development in Premature Infants|To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: ASQ: Ages and stages questionnaire – a parent reported questionnaire that measures child psychomotor development. Total range of ASQ score: 0 to 300 points. Higher scores indicate higher level of psychomotor development.|13 months of age|This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.||Score on ASQ scale||Standard Deviation|Mean
24438|NCT01694108|Secondary|Standardized Weight at 13 Months|To test that infants who get the BCG vaccine at birth respond in weight.The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|This analysis only includes children with available follow-up data from telephone interviews or clinical examinations. As opposed to the primary outcome, follow-up was lower than 100%.||Weight z-score at 13 months||Standard Deviation|Mean
24439|NCT01694108|Secondary|Specific IgE|Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35.|13 months of age|This analysis includes children who participated with blood samples for this sub-study regarding specific IgE.||participants|||Number
24440|NCT01694108|Secondary|Atopic Dermatitis|"To test if BCG vaccination within 7 days after birth influence the risk of atopic dermatitis defined by clinical examination at 13 months of age using scoring atopic dermatitis (SCORAD) or by parental report of physician diagnosed atopic dermatitis in the telephone interview at 13 months of age."|13 months of age|This analysis includes children with follow-up data from clinical examination or telephone interview. As opposed to the register-based primary outcome, adherence to telephone-interview and clinical examination was slightly lower than 100%.||participants|||Number
24441|NCT01694108|Secondary|Antibiotics|To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. Use of antibiotics was defined as one or more precriptions of systemic antibiotics (ATC groups J01, J02, J05, all subgroups inclusive).|0-15 months of age|Intention-to-treat||participants|||Number
24442|NCT01694108|Primary|All-cause Hospitalisations|To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants.|0-15 months of age|Intention-to-treat||Events|||Number
24443|NCT01693653|Secondary|Safety|The study was terminated. No data were collected for this outcome measure.|9 moths||||||
24444|NCT01693653|Secondary|BDCAF|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24445|NCT01693653|Secondary|MDHAQ|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24446|NCT01693653|Secondary|BSAS|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24447|NCT01693653|Secondary|Gential Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24448|NCT01693653|Secondary|Oral Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24449|NCT01693653|Secondary|Treatment Failures|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24450|NCT01693653|Secondary|Oral Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24451|NCT01693653|Secondary|Genital Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months||||||
24452|NCT01693653|Primary|Primary Outcome|The study was terminated. No data were collected for this Outcome Measure.|9 months|The study was terminated. No data were collected for this Outcome Measure.|||||
24453|NCT01693367|Secondary|WOMAC|To assess pain, stiffness, and physical function|Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
24454|NCT01693367|Secondary|Full Weight-bearing Status|"Assessment of the timepoint when the patient :~can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds~can walk without walking aid~has no intake of analgesics~has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable"|weekly measurement at home|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
24455|NCT01693367|Secondary|Range of Motion (ROM)|Assessment of passive ROM of the knee (flexion – extension)|6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
24456|NCT01693367|Secondary|Quality of Life (EuroQol-5D)||Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
24457|NCT01693367|Secondary|Timed Up-and-go Test (TUG)|"The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command ready - go and stopped when the seated position is reached again."|12 weeks ± 7 days, 6 months ± 30 days|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
24458|NCT01693367|Primary|Western Ontario and McMaster Universities Index (WOMAC)|To assess pain, stiffness, and physical function|12 months after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.|||||
24459|NCT01693185|Secondary|Indigence of Patient's Recall|The numbers of patients who recalled instructions and explanations given during colonoscopy|after colonoscopy|||participants|||Number
24460|NCT01693185|Secondary|Endoscopist Satisfaction|endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm|5 min after the colonoscopy|||units on a scale||Inter-Quartile Range|Median
24461|NCT01693185|Secondary|Patient's Distress Score|patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100|5 min after the end of colonoscopy|||units on a scale||Inter-Quartile Range|Median
24462|NCT01693185|Secondary|Bispectra Lindex Score|Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100|every 5 min during and after colonoscopy|||units on a scale||Full Range|Median
24464|NCT01693185|Primary|The Recovery Time|"Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit~Aldrete score~Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0~O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0~Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0~Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0~Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0~To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and –R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference."|every 5 minutes after completing colonoscopy up to 30 min|||minute||Inter-Quartile Range|Median
24465|NCT01692938|Primary|Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.|1 Month|||decibels||Standard Deviation|Mean
24466|NCT01692938|Primary|Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.|1 Month|||decibels||Standard Deviation|Mean
24467|NCT01692782|Secondary|Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.|The WRAADDS measured the severity of the target symptoms of adults with ADHD. It measured symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) and summarized each of the 7 categories on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = quite a bit, 4 = very much). The WRAADDS total score is defined as sum of all 28 item subscores (range 0 - 56).|Weeks 1, 2, 3, 4|Intent to treat||units on a scale||Standard Error|Least Squares Mean
24468|NCT01692782|Secondary|The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.||Weeks 1, 2, 3, 4|Intent to treat||participants|||Number
24469|NCT01692782|Secondary|Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The even number items (2, 4, 6, 8, 10, 12, 14, 16, 18) assess hyperactive impulsive symptoms and the odd number items (1, 3, 5, 7, 9, 11, 13, 15, 17) assess inattentive symptoms. The ADHD inattentiveness subscale score is defined as sum of items (1, 3, 5, 7, 9, 11, 13, 15, 17) scores (range 0 - 27). The ADHD hyperactive impulsive subscale score is defined as sum of items (2, 4, 6, 8, 10, 12, 14, 16, 18) scores (range 0 - 27).|Weeks 1, 2, 3, 4|Intent to treat||units on a scale||Standard Error|Least Squares Mean
24470|NCT01692782|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.|The CGI-S modified asked the clinician one question: Considering your total clinical experience with adult ADHD, how mentally ill is the subject at this time?”.The clinician’s answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = ng the most extremely ill subjects.|Weeks 1, 2, 3, 4|Intent to treat||units on a scale||Standard Error|Least Squares Mean
24471|NCT01692782|Secondary|Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores (range 0 - 54).|Weeks 1, 2, 3|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
24472|NCT01692782|Primary|Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV)|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.|4 Weeks|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
24473|NCT01692691|Secondary|Median Survival of Patients Treated With Combination.||8 weeks||||||
24474|NCT01692691|Secondary|Median Duration of Response||8 weeks||||||
24475|NCT01692691|Secondary|Response Rate||8 weeks|||percentage of participants||95% Confidence Interval|Number
24476|NCT01692691|Primary|Progression Free Survival of Patients With Stage IV Melanoma Who Have Had Disease Progression on at Least One Prior Systemic Therapy||8 weeks|||participants|||Number
24477|NCT01692340|Primary|Time of Maximal Carotenoid Concentration|We will determine when the maximal carotenoid concentration is achieved in the plasma|0 to 48 hours|||hours||Standard Error|Mean
24478|NCT01692340|Primary|Maximal Plasma Carotenoid Concentration|We will determine the average maximal plasma carotenoid concentration in healthy volunteers|0 to 48 hours|||micromol||Standard Error|Mean
24480|NCT01692340|Primary|Plasma Half Life of Labeled Carotenoid|We will study the half life of isotopically labeled carotenoids.|labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.|||days||Standard Error|Mean
24481|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)|Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
24482|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
24483|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
24484|NCT01692301|Secondary|Change From Baseline in Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 * msDBP + msSBP)/3.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
24485|NCT01692301|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (msPP)|Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
24486|NCT01692301|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
24487|NCT01692301|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).||mmHg||Standard Error|Least Squares Mean
24488|NCT01692301|Secondary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis.||mmHg||Standard Error|Least Squares Mean
24489|NCT01692301|Secondary|Change From Baseline in Mean Pulse Wave Velocity (PWV)|"Pulse wave velocity recordings were performed on patient while in a supine, face-up position.~Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52."|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12 , week 52).||meter/second||Standard Error|Least Squares Mean
24490|NCT01692301|Secondary|Change From Baseline in Mean Central Pulse (CPP) Pressure||Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12, week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis||mmHg||Standard Error|Least Squares Mean
26920|NCT01656161|Secondary|Number of Participants Who Presented a Real “Acute-on-chronic” (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)||Day 171|||participants|||Number
24491|NCT01692301|Primary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 12 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12).||mmHg||Standard Error|Least Squares Mean
24492|NCT01691885|Primary|Mean Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVI) at the End of the Overall Treatment Period|RVEDVI is a measure of the volume of blood in the right ventricle at the end of diastole, normalized over body surface area and was measured using Cardiac Magnetic Resonance (CMR) imaging. RVEDVI is calculated as the right ventricular end diastolic volume (RDEDV) divided by the body surface area (BSA). The change from Baseline in RVEDVI was analyzed using a mixed model analysis with period, treatment group, and Baseline RVEDVI fitted as fixed effects and participants fitted as a random effect. The Baseline is defined as the assessment performed pre-dose at Day 1 of Treatment Period 1. The change from Baseline is calculated as the RVEDVI value at the end of each treatment period minus the Baseline value. The Per Protocol (PP) Population was comprised of all participants in the modified intent-to-treat (mITT) Population not identified as having deviations considered to impact the primary efficacy analysis.|Baseline and end of Treatment Period (7 days)|PP Population. Only those participants available at the specified time points were analyzed||Milliliter per meter square (mL/m^2)||Standard Error|Least Squares Mean
24493|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)|Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500.|Day 1 of treatment through Week 24|All participants who received at least 1 dose of study drug||Participants|||Number
24494|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4|Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0.|Day 1 of treatment to Week 24|All participants who received at least 1 dose of study drug||Participants|||Number
24495|NCT01691794|Primary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|Day 1 of treatment through Week 24|All participants who received at least 1 dose of study drug||Participants|||Number
24496|NCT01690546|Secondary|Number of Participants That Self Reported Illicit Drug Use|Participants reported on any illicit drug use to include Cocaine marijuana opiates|4 weeks|||participants|||Number
24497|NCT01690546|Secondary|Use of Ancillary Medications.|Number of participants that took ancillary medication|baseline to week 1|||participants|||Number
24498|NCT01690546|Secondary|Percentage of Participants With Adherence to Medication (Naltrexone)|Participant who took Naltrexone as prescribed.|Day 1 to Day 8 (+/- 2 days)|||percentage of participants|||Number
24499|NCT01690546|Secondary|Percentage of Participants Who Adhered to Study Visits.||baseline to end of study (approximately 40 days)|||percentage of participants|||Number
24500|NCT01690546|Secondary|Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire|"Questionnaire consisted of 3 questions.~Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5).~Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5).~Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5).~Lower scores represent greater satisfaction."|Day 9|||units on a scale||Standard Deviation|Mean
24501|NCT01690546|Secondary|Illicit Drug Use, Measured by Urine Drug Testing|number of participants that tested positive for marijuana, cocaine, and opiates.|4 weeks|||participants|||Number
24502|NCT01690546|Secondary|Craving|Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from ‘not at all’ (0) to ‘more than ever’ (100). The higher the score the higher the craving.|4 weeks|||units on a scale||Standard Deviation|Mean
25176|NCT01680861|Primary|BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant|BPAR (biopsy-proven acute rejection) incidence during the first 12 months post-transplant. Grading is determined using standard Banff criteria.|1 year|||participants|||Number
24503|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms."|4 weeks|||units on a scale||Standard Deviation|Mean
24504|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal."|4 weeks|All participants who received the Extended Release Injectable NTX||units on a scale||Standard Deviation|Mean
24505|NCT01690546|Primary|Retention in Treatment|After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.|4 weeks|All participants who received the Extended Release Injectable NTX||participants|||Number
24506|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8|Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
24507|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4|Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
24508|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||grams||Standard Deviation|Mean
24509|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant does not respond to air stimulation, 1 – participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
24510|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||grams||Standard Deviation|Mean
24511|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant does not respond to air stimulation, 1 – participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.||Score on a scale||95% Confidence Interval|Least Squares Mean
24512|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Days 7-14)||Days 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||percentage of change in time/day||95% Confidence Interval|Mean
24513|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Day 0-2)||Day 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||percentage of change in time/day||95% Confidence Interval|Mean
24514|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)||Days 0-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||percentage of change in time/day||95% Confidence Interval|Mean
24830|NCT01686451|Secondary|Treatment Efficacy|Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.|Measured at baseline and week 4|||mmol/L||Standard Deviation|Mean
24515|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 7-14)||Day 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||log10CFU/ml/day||95% Confidence Interval|Mean
24516|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 0-2)||Days 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||log10CFU/ml/day||95% Confidence Interval|Mean
24517|NCT01691534|Primary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).||14 consecutive days of treatment|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data||log10CFU/ml/day||95% Confidence Interval|Mean
24518|NCT01691521|Secondary|Mean Change From Baseline in the St. George’s Respiratory Questionnaire Total Score at Week 32|The St. George’s Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. The lowest possible value is zero and the highest possible value is 100. The higher values correspond to greater impairment in quality of life. The questionnaire was administered at Baseline (Visit 2) and at the Exit Visit (approximately 4 weeks after the last dose of study treatment). The change from baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using analysis of covariance with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, and treatment.|Baseline, Week 32|ITT Population. Note that only participants with a Baseline and Week 32 assessment were included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
24519|NCT01691521|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32|FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using mixed model repeated measures with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by baseline and visit by treatment group.|Baseline, Week 32|ITT Population. Only participants with a Baseline FEV1 available and at least one post-Baseline FEV1 measurement were analyzed.||Milliliters (mL)||Standard Error|Least Squares Mean
24520|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year|Clinically significant exacerbations of asthma is defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population||Number of exacerbations per year|||Number
24521|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population||Number of exacerbations per year|||Number
24522|NCT01691521|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|Modified Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of trial medication. ‘Modified’ implies that, in cases where there is is a discrepancy between randomized and actual treatment the analysis used the actual treatment received by the participant rather than the randomized treatment.||Number of exacerbations per year|||Number
25177|NCT01680848|Primary|Percentage of Participants Who Indicate Surgical Intervention||Up to 24 months|||percentage of the dentists|||Number
24523|NCT01691508|Secondary|Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|BL dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent change of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (MN dose minus BL dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. For participants who withdrew from the study prior to the Maintenance Phase, and for participants with a lack of asthma control during the Maintenance Phase, a value equal to the minimum percent reduction in OCS use across all subjects was imputed for the analysis.|Baseline; Weeks 20 to 24|ITT Population||Percentage reduction in OCS dose||95% Confidence Interval|Median
24524|NCT01691508|Secondary|Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The number of participants who achieved a total reduction of OCS dose was based on the value of the MN dose. Total reduction implied no OCS use during the entire MN phase. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population||Participants|||Number
24525|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control|Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg was based on the value of the MN dose. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population||Participants|||Number
24526|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|ITT Population||Participants|||Number
24527|NCT01691508|Primary|Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The percent reduction of OCS was categorized as: 90 to 100%; 75 to <90%; 50 to <75%; >0 to <50%; no decrease in prednisone dose, or lack of asthma control, or withdrawal (WD) from treatment. Analysis was performed using a proportional odds model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.||Participants|||Number
24528|NCT01691482|Secondary|Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population||Liters||Standard Deviation|Mean
24529|NCT01691482|Secondary|Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population||Liters||Standard Deviation|Mean
24540|NCT01691326|Other Pre-specified|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Ratio||95% Confidence Interval|Geometric Mean
24530|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population||Liters||Standard Error|Mean
24531|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population||percentage of days||Standard Deviation|Mean
24532|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population||percentage of days||Standard Deviation|Mean
24533|NCT01691482|Secondary|The Maximal Bronchodilator Response for the First Administered Agent|The maximal bronchodilator response for the first administered agent is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) 1 hour post-dose of the first bronchodilator minus the pre-dose. The maximal bronchodilator response for the second agent is defined as the FEV1 1 hour post-dose of the second bronchodilator minus the FEV1 at 1 hour post-dose of the first bronchodilator. The maximal bronchodilator response for the combination is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) at 1 hour post-administration of the second bronchodilator minus the corresponding pre-dose FEV1. Derived FEV1 response is FEV1 change from 0 hours (0H) for the first agent assessment (at 1 hour [1H]); change from 1H for the second agent assessment (at 2 hours [2H]); and change from 0H for the combination assessment (at 2H). Data were adjusted for FEV1, smoking status, and center.|up to 10 days|Efficacy Population||Liters||Standard Error|Least Squares Mean
24534|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Coefficient of Variation|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population: participants in the Intent-to-Treat Population (all participants who were randomized and received at least one bronchodilator in the treatment period) who completed pre- and post- bronchodilator assessments for at least 17 visits, with no more than 3 consecutive missing days||Liters||Standard Error|Mean
24535|NCT01691339|Other Pre-specified|Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
24536|NCT01691339|Other Pre-specified|Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.||Participants|||Number
24537|NCT01691339|Other Pre-specified|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.||Participants|||Number
24538|NCT01691339|Other Pre-specified|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) up to Day 21 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
24539|NCT01691339|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|"Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.~Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
24541|NCT01691326|Other Pre-specified|Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.|Day 28 after final vaccination|Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Participants|||Number
24542|NCT01691326|Other Pre-specified|Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Participants|||Number
24543|NCT01691326|Other Pre-specified|Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the influenza virus antigens were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
24544|NCT01691326|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|"Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.~Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.~Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
24545|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug|baseline through 24 hours|||participants|||Number
24546|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug|baseline through 4 hours|||participants|||Number
24547|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to Day 70 of study|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
24548|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 60 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
24549|NCT01691248|Primary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 30 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
24550|NCT01691014|Secondary|Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12|HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Baseline, Month 3, 6, 12|"EAS included all participants that provided at least 1 post-baseline assessment. Here, n signifies number of participants evaluable for this outcome measure at the specified time points."||units on a scale||Standard Deviation|Mean
24551|NCT01691014|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12|DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity.|Month 3, 6, 12|EAS included all participants that provided at least 1 post-baseline assessment. Here,”n” signifies number of participants evaluable at the specified time points for this outcome measure.||units on a scale||Standard Deviation|Mean
24552|NCT01691014|Secondary|Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment|Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.|Month 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
24553|NCT01691014|Secondary|Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 3, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
24554|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
24555|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
24556|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
24557|NCT01691014|Primary|Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
24558|NCT01691014|Primary|Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.|||||
24559|NCT01690923|Primary|AHI on Nasal Mask and Pillows Mask|AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour|7 days|||events/hour||Standard Deviation|Mean
24560|NCT01690923|Secondary|Usability|Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)|After 7 days of use|||Units on a scale||Inter-Quartile Range|Median
24561|NCT01690299|Secondary|Psoriasis Flare/Rebound|Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.|From the start date on or after the first dose date of study drug and prior to Week 16 for those who entered the Apremilast Extension Phase (Weeks 16-104) or within 28 days of the last dose date for those who discontinued in the Placebo-Controlled Phase|Safety population includes all participants who were randomized and received at least one dose of study drug.||participants|||Number
24562|NCT01690299|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for those who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject’s health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.|From the start date on or after the first dose date of study drug and prior to Week 16 for those who entered the Apremilast Extension Phase (Weeks 16-104) or within 28 days of the last dose date for those who discontinued in the Placebo-Controlled Phase|Safety population includes all participants who were randomized and received at least one dose of study drug. Maximum study treatment duration was 17.6 weeks.||participants|||Number
24632|NCT01689532|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24|Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
25178|NCT01680666|Secondary|Number of Complications||April 2008-September 2011||||||
24563|NCT01690299|Secondary|Percentage of Participants With a Lattice System Physician’s Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The Lattice System Physician’s Global assessment by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale, from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.|Baseline to Week 16||08/2016||||
24564|NCT01690299|Secondary|Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).~Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value."|Baseline and Week 16||08/2016||||
24565|NCT01690299|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16||08/2016||||
24566|NCT01690299|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|A participant was classified as having at least a 50% improvement in PASI score from baseline, which was equivalent to a percent change from baseline ranging from −100% to −50%. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.|From Baseline to Week 16||08/2016||||
24567|NCT01690299|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA%) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA - baseline BSA) / baseline BSA (%)."|Baseline to Week 16||08/2016||||
24568|NCT01690299|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline and Week 16||08/2016||||
24569|NCT01690299|Secondary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline and Week 16||08/2016||||
24587|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
25179|NCT01680666|Secondary|Number of Arterial Punctures||April 2008-September 2011||||||
25180|NCT01680666|Secondary|Total Number of Venous Cannulation Attempts||April 2008-September 2011||||||
24570|NCT01690299|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).||Percentage of participants|||Number
24571|NCT01690273|Secondary|Chest Expansion|Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
24572|NCT01690273|Secondary|Finger Floor Distance|Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
24573|NCT01690273|Secondary|Tragus-coronoid Distance|lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
24574|NCT01690273|Secondary|Chin-coronoid Distance|lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
24575|NCT01690273|Secondary|MASES|Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation|Baseline and 16 Weeks|||Number of painful tender points||Standard Deviation|Mean
24576|NCT01690273|Secondary|Short Form-12 (MCS)|Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
24577|NCT01690273|Secondary|Short Form-12 (PCS)|Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
24578|NCT01690273|Secondary|Stiffness Scale|Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
24579|NCT01690273|Secondary|Pain Scale|Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
24580|NCT01690273|Secondary|Thoracolumbar Mobility|Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation|Baseline and 16 Weeks|||Centimeters||Standard Deviation|Mean
24581|NCT01690273|Primary|Global Evaluation Self Reported|Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Median
24582|NCT01690273|Primary|Ankylosing Spondylitis Disease Activity Scale -Disease Activity|Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
24583|NCT01690273|Primary|Disease Activity Index|BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
24584|NCT01690273|Primary|Mobility Index|Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)|Baseline and 16 weeks|||units on a scale from 0 to 10||Standard Deviation|Mean
24585|NCT01690273|Primary|FUNCTIONAL INDEX|BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.|Baseline and 16 Weeks|||units on a scale||Standard Deviation|Mean
24586|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24597|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)|baseline and month 6|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24588|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24589|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24590|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 - physical component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24591|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24592|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24593|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24594|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)|baseline and month 9|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24595|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)|baseline and month 6|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24596|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24703|NCT01688921|Secondary|Number of Subjects With Complaints Within 30 Minutes Following Vaccination||Within 30 minutes post-vaccination|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).||participants|||Number
24598|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24599|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)|baseline and 6 month|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24600|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).|baseline and month 9|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24601|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).|baseline and month 6|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS (Statistical Package for the Social Sciences ) - methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.||units on a scale||Standard Deviation|Mean
24602|NCT01690052|Secondary|Number of Participants With Adverse Effects Associated With the Medications|We will record the number and type of side effects associated with each medication.|4 weeks||||||
24603|NCT01690052|Primary|Change From Baseline in Saliva Production in ml.|"The primary outcome measure was the change of stimulated and non-stimulated saliva in ml from the baseline record.~At each appointment (weekly), participants will provide 2 saliva samples to measure their current salivary output. The first measurement will be obtained by having the patient spit as much as he or she could into a cup for five minutes. The amount of saliva in ml will be recorded.~The second measurement will be obtained in a similar manner with the addition of having the patient chew on a block of unflavored wax. Patients will complete weekly questionnaires to help determine which side-effects they experience as they take the medications."|4 weeks|||ml||Standard Deviation|Mean
24604|NCT01690000|Secondary|Changes in Calcium Homeostasis|Calcium homeostasis will be analyzed through blood and urines samples|baseline, after 3, 6, 9 months, and end of study (after 12 months)||||||
24605|NCT01690000|Primary|Changes in Bone Mineral Density (BMD)|Effects of melatonin on BMD will be assessed through DXA-scans|baseline and end of study (after 12 months)|||percentage of change in BMD||Standard Error|Mean
24606|NCT01689857|Secondary|Satisfaction for Serviceability|Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire|the end of the 3 month of the treatment||||||
24607|NCT01689857|Primary|Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months|"Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.~vascularity(range from normal(0 point) to purple(3point)~pigmentation(range from normal(0 point) to hyper-pigmentation(3point)~pliability(range from normal(0 point) to contracture(5point)~height (range from flat(0 point) to above 5mm(3point)~pain(range from none(0 point) to Require medication(2point)~itchiness(range from none(0 point) to Require medication(2point)~We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition."|Baseline and 3 months|All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.||units on a scale||Standard Deviation|Mean
24608|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment||Month 4|||percentage of participants|||Number
24609|NCT01689649|Secondary|General Clinical Assessment Before and After Treatment|The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).|Baseline (Day 0) and Month 4|||percentage of participants|||Number
24610|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks||Month 4|||percentage of participants|||Number
24611|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks||Month 1, Month 3 and Month 4|||percentage of participants|||Number
24612|NCT01689649|Primary|Percentage of Seizure Free Participants During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4|||percentage of participants|||Number
24613|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4|||percentage of participants|||Number
24614|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4|||percentage of participants|||Number
25181|NCT01680666|Primary|Success of Central Venous Cannulation at First Attempt.||April 2008-September 2011|||participants|||Number
24615|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52|"Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24616|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52|The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24617|NCT01689532|Secondary|Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24618|NCT01689532|Secondary|Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24619|NCT01689532|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||minute||Standard Deviation|Mean
24620|NCT01689532|Secondary|Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52|HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.|Baseline, Weeks 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale*week||Standard Deviation|Mean
24621|NCT01689532|Secondary|Percentage of Participants Maintaining HAQ-DI Response|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of > -0.22 in HAQ-DI score.|Baseline upto Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24622|NCT01689532|Secondary|Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of > -0.22 from baseline in HAQ-DI score.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24623|NCT01689532|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, at Week 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24624|NCT01689532|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI <=3.3; Low Disease Activity SDAI >3.3 and <=11; Moderate Disease Activity SDAI >11 and <=26; High Disease Activity SDAI >26.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24625|NCT01689532|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24|The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24626|NCT01689532|Secondary|Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52|The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 to 10 scale.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24627|NCT01689532|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician’s global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at the visit.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24628|NCT01689532|Secondary|Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||units on a scale||Standard Deviation|Mean
24629|NCT01689532|Secondary|Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.|At Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24630|NCT01689532|Secondary|Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24631|NCT01689532|Secondary|Percentage of Participants Who Achieved Major Clinical Response at Week 52|Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).|Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24633|NCT01689532|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, ‘n’ signifies those participants who were evaluable for the specific timepoint.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
24634|NCT01689532|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24|Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
24635|NCT01689532|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24|Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
24636|NCT01689532|Secondary|Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24|Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
24637|NCT01689532|Secondary|Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24|Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
24638|NCT01689532|Secondary|Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24|Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percent change||Standard Deviation|Mean
24639|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response|The ACR 90 Response is defined as >=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24640|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response|The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24641|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response|The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
24642|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.||percentage of participants|||Number
25011|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 422|Analysis was done on safety set||Subjects|||Number
24643|NCT01689532|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.|Baseline upto Week 68|Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.||participants|||Number
24644|NCT01689519|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 28 August 2015 Overall Survival data cut-off (up to 2 years, 8 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Months||95% Confidence Interval|Median
24645|NCT01689519|Secondary|Duration of Response|Duration of response was defined as the time from first occurrence of a documented confirmed objective response until the time of disease progression, as determined by investigator review of tumor assessments using Response Evaluation Criteria in Solid Tumors v1.1 or death from any cause during the study. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received. Only participants with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
24646|NCT01689519|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors v1.1. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Percentage of participants||95% Confidence Interval|Number
24647|NCT01689519|Secondary|Overall Survival|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Months||95% Confidence Interval|Median
24648|NCT01689519|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.||Months||95% Confidence Interval|Median
24649|NCT01689441|Secondary|Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours|NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations.|48 hours|"The discrepancy in number of participants analyzed for this outcome vs. other outcomes is due to urine samples not being available in all participants"||mg/mg||Inter-Quartile Range|Median
24650|NCT01689441|Secondary|Plasma Interleukin-6 (IL-6) Levels at 48 Hours||48 hours|||pg/ml||Inter-Quartile Range|Median
24651|NCT01689441|Primary|Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours||48 hours|||ng/ml||Inter-Quartile Range|Median
24652|NCT01689363|Secondary|Allergic Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
24653|NCT01689363|Secondary|Erythema Responder Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||percentage of participants|||Number
24654|NCT01689363|Secondary|Local Itchiness Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||percentage of participants|||Number
24655|NCT01689363|Secondary|Allergic Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
24656|NCT01689363|Secondary|Observed Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
24657|NCT01689363|Secondary|Observed Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||mm||Standard Deviation|Mean
24658|NCT01689363|Secondary|Erythema Responder Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||percentage of participants|||Number
24659|NCT01689363|Secondary|Local Itchiness Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||percentage of participants|||Number
24660|NCT01689363|Secondary|Allergic Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
24661|NCT01689363|Secondary|Allergic Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
24662|NCT01689363|Secondary|Observed Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
24663|NCT01689363|Secondary|Observed Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||mm||Standard Deviation|Mean
24664|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized||participants|||Number
24665|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments||participants|||Number
24666|NCT01689350|Secondary|Adverse Reaction ( Infection )|Flu-like symptoms, Upper respiratory tract infection，and the etc.|one month|||participants|||Number
24667|NCT01689350|Primary|Adverse Reaction (Leucopenia)|The count of white cells < 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.|one month|||participants|||Number
24668|NCT01689337|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 60|The safety analysis set included all participants who received at least 1 dose of trial drug.||participants|||Number
24669|NCT01689337|Secondary|Six-minute Walk Test|Six (6)-minute walk test is used to measure gait function and for pre- and post-operative evaluation in cartilage injury repair. Maximum comfortable distance (in meters) that a participant can walk in 6 minutes was to be reported.|Every 3 months up to 5 years beyond Month 6 post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24670|NCT01689337|Secondary|Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score|The MOCART score is used to describe the constitution of the cartilage repair tissue and the surrounding structures.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24671|NCT01689337|Secondary|Volume of the Refilled Cartilage|Volume of the refilled cartilage was to be measured by MRI.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24672|NCT01689337|Secondary|Composition of the Refilled Cartilage Using T2 Mapping|The transverse relaxation time T2 mapping is an MRI technique that is able to evaluate collagen organization and orientation within cartilage. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24673|NCT01689337|Secondary|Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score|The Lysholm knee scale is a physician-reported outcome measure to assess knee function after ligament injury. It is scaled from 0 to 100 with higher scores representing better function. Change from baseline in Lysholm knee scale score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24674|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score|The LEAS is an 18-level single-question self-administered scale that has been validated as a clinical outcome measure for the assessment of participants’ actual activity levels. The LEAS is scaled from 1 to 18, with 18 indicating levels of highest activity. Change from baseline in LEAS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24675|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score|Knee pain was to be rated by the participant using an 11-point NRS of pain intensity. The NRS is scaled from 0 (no pain) to 10 (worst possible pain). Change from baseline in NRS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24676|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, FSR, and impact on QOL (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in total KOOS score; other symptoms, knee-related QOL, and FSR sub-scores; and total KOOS minus FSR sub-score was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24677|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scores for Pain and Activities of Daily Living (ADL)|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, function in sport and recreation (FSR), and impact on quality of life (QOL) (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in pain and ADL sub-scores was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24678|NCT01689337|Secondary|Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years beyond 6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24679|NCT01689337|Primary|Composition of the Refilled Cartilage Measured by Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) Using T1 Relaxation Time at Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.|||||
24705|NCT01688921|Primary|Anti Influenza Type A/H3N2 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|||Percent of Participants|||Number
24680|NCT01689324|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®|"Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.~Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set||Participants|||Number
24681|NCT01689324|Other Pre-specified|Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
24682|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set||Titers||95% Confidence Interval|Geometric Mean
24683|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set||Titers||95% Confidence Interval|Geometric Mean
24684|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
24685|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.||Percentage of Participants|||Number
24686|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.|Day 0 pre-vaccination|Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
24687|NCT01689324|Primary|Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
24688|NCT01689324|Primary|Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|"Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.~Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL."|Day 28 post-vaccination|Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
24689|NCT01689324|Primary|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.|Day 28 post-vaccination|Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set||Percentage of Participants|||Number
24690|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Volume of distribution at steady state (Vss).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||L||Geometric Coefficient of Variation|Geometric Mean
24691|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Systemic clearence (CL) and renal clearance (CLr) on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||L/h||Geometric Coefficient of Variation|Geometric Mean
24704|NCT01688921|Primary|Anti Influenza Type B Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Percent of Participants|||Number
24692|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Maximum plasma concentration (Cmax µg/mL) on Day 1 after single infusion , maximum plasma concentration at steady state (Css,max µg/mL) after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||ug/mL||Geometric Coefficient of Variation|Geometric Mean
24693|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C|Time to Cmax (tmax)|Day 1|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||(h)||Full Range|Median
24694|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Terminal half-life (t1/2), on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)||h||Geometric Coefficient of Variation|Geometric Mean
24695|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Area under the plasma concentration-time curve from zero extrapolated to infinity (AUC µg*h/mL) or AUC(0-last) in Part A on Day 1 after single infusion, area under the plasma concentration-time curve at steady state after multiple infusion (AUCss µg*h/mL).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness.||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
24696|NCT01689207|Primary|Safety Profile - Number of Subjects With at Least 1 AE|from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.|Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)|Safety population||Participants|||Number
24697|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Clinic Database.|Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.||Events per 1,000 person-months|||Number
24698|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Hospital Database.|Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.||Events per 1,000 person-months|||Number
24699|NCT01689155|Primary|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.|Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.|Day 0 up to Day 75 post-vaccination|Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.||Events per 1,000 person-months|||Number
24700|NCT01688921|Secondary|Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again||28 Days|Safety population||Percent of Participants|||Number
24701|NCT01688921|Secondary|Number of Subjects With Spontaneously Reported Adverse Events|"Subjects will be asked to report any other symptoms experienced in addition to the solicited immediate and vaccine reactogenicity events. Any other events reported will be tabulated as spontaneously reported adverse events."|28 days|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).||participants with spontaneous AEs|||Number
24702|NCT01688921|Secondary|Number of Subjects With Vaccine Reactogenicity Events|Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.|Day 0, 1, 2, 3, 4, 5, and 6|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card.||participants|||Number
24706|NCT01688921|Primary|Anti Influenza Type A/H1N1 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Percent of Participants|||Number
24707|NCT01688921|Primary|Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Titers||Standard Deviation|Geometric Mean
24708|NCT01688921|Primary|Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Titers||Standard Deviation|Geometric Mean
24709|NCT01688921|Primary|Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.||Titers||Standard Deviation|Geometric Mean
24710|NCT01688882|Secondary|Number of Patients Investigator Global Assessment Score Over 12 Weeks|Investigator’s Global Assessment (IGA) - (scale of 0 to 4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe)|Baseline (week 0), week 6 and week 12|Pharmacodynamics (PD) analysis set included all randomized patients.||Number of participants|||Number
24711|NCT01688882|Secondary|Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 6 weeks based on the CGA-C score in bullous pemphigoid (BP).~A patient with a CGA-C score of 3 or 4 indicating marked improvement from baseline at 6 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|6 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.||number of participants|||Number
24712|NCT01688882|Primary|Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 12 weeks based on the CGA-C in bullous pemphigoid (BP).~A patient with a CGA-C score of 3 or 4 indicating ‘at least marked improvement from baseline’ at 12 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|12 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.||number of participants|||Number
24713|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."||ratio||Standard Deviation|Mean
24714|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."||ratio||Standard Deviation|Mean
24715|NCT01688830|Secondary|AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4|AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4|2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
24716|NCT01688830|Secondary|C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)|"Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.~The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). “BLQ” values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable."|1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4|"Pharmadynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
24717|NCT01688830|Secondary|Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran|"Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4~Ae(0-12h,ss) of sum dabigatran"|Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||μg||Geometric Coefficient of Variation|Geometric Mean
24718|NCT01688830|Primary|Number of Subjects With Drug Related Adverse Events (AE)|Frequency of subjects with related adverse events (AE) by treatment|AEs occurring until end of follow-up (Up to 3 months after last drug administration)|Treated set||participants|||Number
24719|NCT01688830|Secondary|Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)|"Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)~Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion."|Up to 7 hours|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||μmol||Geometric Coefficient of Variation|Geometric Mean
24720|NCT01688830|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab|AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
24721|NCT01688830|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab|tmax (time from dosing to maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)||hours||Full Range|Median
24722|NCT01688830|Secondary|Cmax (Maximum Measured Concentration) for Idarucizumab|Cmax (maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|Pharmacokinetic set (PKS) comprises of all subjects (with evaluable observations) in the TS who provided at least 1 PK endpoint and had no important protocol violations relevant to the evaluation of PK and additionally for Part 2 and 3 had no emesis with onset at or before twice the median tmax of dabigatran.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
24723|NCT01688726|Secondary|Non Invasive Tear Film Break-up-time (NIBUT)|NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.||seconds||Standard Deviation|Mean
24724|NCT01688726|Secondary|High Contrast logMAR Time Controlled Visual Acuity (TCVA)|TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.||logMAR||Standard Deviation|Mean
24725|NCT01688726|Primary|Mean Bulbar Conjunctival Staining|The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.||percentage of staining||Standard Deviation|Mean
24726|NCT01688635|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Gtot. Participants were analyzed based on the treatment they received.||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
24727|NCT01688635|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Rmax. Participants were analyzed based on the treatment they received.||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
24728|NCT01688635|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus||30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received||picomoles/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
24774|NCT01687218|Other Pre-specified|Pharmacodynamics|To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24729|NCT01688635|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus|The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.||picomoles*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
24730|NCT01688310|Other Pre-specified|Adverse Events|Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 yr|||participants|||Number
24731|NCT01688310|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).|Within 6 weeks after surgery|||participants|||Number
24732|NCT01688310|Secondary|Overall Patient Satisfaction|Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.|Within 6 weeks after surgery|||participants|||Number
24733|NCT01688310|Secondary|Pain Experienced|Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)|2 days after surgery|||units on 10 point pain scale||Standard Deviation|Mean
24734|NCT01688310|Secondary|Direct Costs|the cost of labor, supplies and equipment|Within 6 weeks after surgery||||||
24735|NCT01688310|Secondary|Time Required for Healing|Time required for healing|Within 6 weeks after surgery|||percentage of participants|||Number
24736|NCT01688310|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey, 5 point Likert scale:~Gomco technique is much easier~Gomco technique is easier~Neutral~Open surgical technique is easier~Open surgical technique is much easier"|1 year|||units on Likert scale||Full Range|Median
24737|NCT01688310|Primary|Intraoperative Duration|Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.|1 year|All participants||Min||Standard Deviation|Mean
24738|NCT01688102|Other Pre-specified|Gene Expression Changes in Skin||baseline vs. 2 months||||||
24739|NCT01688102|Other Pre-specified|Gene Expression Changes in Peripheral Blood||baseline vs. 2 months||||||
24740|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in PTH||2 months and 6 months||||||
24741|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in Calcium||2 months and 6 months||||||
24742|NCT01688102|Secondary|Change in PTH||baseline vs. 2 months vs. 6 months or last observation carried forward (minimum 2 months)||||||
24743|NCT01688102|Secondary|Change in Serum Calcium||baseline vs. 2 months vs. 6 months or last observation carried forward (minimum 2 months)||||||
24744|NCT01688102|Secondary|Change in 25(OH)D||baseline vs. 2 months vs. 6 months or last observation carried forward (minimum 2 months)||||||
24745|NCT01688102|Secondary|Change in Hs-CRP||baseline and 6 months or last observation carried forward (minimum 2 months)||||||
24746|NCT01688102|Secondary|Change in Triglycerides||baseline 6 months or last observation carried forward (minimum 2 months)||||||
24747|NCT01688102|Secondary|Change in HDL Cholesterol||baseline and 6 months or last observation carried forward (minimum 2 months)||||||
24748|NCT01688102|Secondary|Change in Total Cholesterol||baseline and 6 months or last observation carried forward (minimum 2 months)||||||
24749|NCT01688102|Primary|Change in LDL Cholesterol Level||baseline and 6 months or last observation carried forward (minimum 2 months)|||mg/dl||Standard Deviation|Mean
24750|NCT01688050|Primary|Device Success|Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.|30 days|One patient had device compression (counted as a failure conservatively although the compression was not consistent with collapse of the proximal end of the device) and one patient had a site-reported Type I endoleak requiring secondary intervention.||participants|||Number
24751|NCT01688050|Primary|Aortic Injury-related Mortality|Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.|30 days|||participants|||Number
24752|NCT01688050|Primary|All-cause Mortality||30 days|One death was adjudicated as unrelated by the Clinical Events Committee (CEC).||participants|||Number
24753|NCT01687790|Secondary|Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.|Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).|1 year|Analysis population included the number of indeterminate lesions that had positive pathology results.||lesions|||Number
24754|NCT01687790|Primary|Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.|The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).|1 year|Analysis population included the number of indeterminate lesions that had negative/benign pathology results.||lesions|||Number
24755|NCT01687270|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment~Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)"|Up to Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
24756|NCT01687270|Secondary|HCV RNA and Change From Baseline at Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
24757|NCT01687270|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24||Weeks 12 and 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
24825|NCT01686451|Other Pre-specified|Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group|We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.|Measured at baseline and week 4|||number of pills|||Number
24758|NCT01687270|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4, 24, and 48|Full Analysis Set||percentage of participants|||Number
24759|NCT01687270|Primary|Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event||Baseline to Week 24|Safety Analysis Set||percentage of participants|||Number
24760|NCT01687270|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were enrolled and received at least one dose of study medication.||percentage of participants|||Number
24761|NCT01687257|Secondary|Change From Baseline in Model for End Stage Liver Disease (MELD) Scores|"MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20.~Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.||percentage of participants|||Number
24762|NCT01687257|Secondary|Change From Baseline in Child-Pugh-Turcotte (CPT) Score|"CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline.~Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.||percentage of participants|||Number
24763|NCT01687257|Secondary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment|HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug.|Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)|Participants who were randomized to the study with available data at baseline and end of observation or end of treatment were analyzed.||mmHg||Standard Deviation|Mean
24764|NCT01687257|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.||percentage of participants|||Number
24765|NCT01687257|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 48 weeks|Participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
24766|NCT01687257|Secondary|Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 24, and 48|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.||percentage of participants|||Number
24767|NCT01687257|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period.|Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)|Participants who were randomized to the study.||percentage of participants|||Number
24768|NCT01687218|Other Pre-specified|Problem Practices|To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24769|NCT01687218|Other Pre-specified|Product Sharing|To determine the level of sharing of study products with non-participants and to assess with whom products are shared|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24770|NCT01687218|Other Pre-specified|Sexual Activity and Condom Use|To examine whether sexual activity or condom use varies by product used|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24771|NCT01687218|Other Pre-specified|Factors Associated With Adherence|To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24772|NCT01687218|Other Pre-specified|Correlation Between PK and Adherence|To assess correlation of PK with adherence measures|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24773|NCT01687218|Other Pre-specified|Mucosal Immunity|To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24775|NCT01687218|Secondary|Adherence|To evaluate and compare adherence to daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All secondary analyses are based on the data from evaluable participants||participants|||Number
24776|NCT01687218|Secondary|Pharmacokinetics|To compare systemic and local PK among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel|27 weeks (three 8-week product use periods with 1-week washout periods between them)||||||
24777|NCT01687218|Primary|Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.||participants|||Number
24778|NCT01687218|Primary|Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.||participants|||Number
24779|NCT01687218|Primary|Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.||participants|||Number
24780|NCT01687218|Primary|Safety: Grade 2 or Higher Adverse Events|Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Among the 187 evaluable participants. One participant was terminated before the Initiate Period visit of his/her Period 3 (Oral Tablet regimen period). Thus, this participant is removed from the analysis of the oral period regimen.||participants|||Number
24781|NCT01687114|Primary|Proanthocyanidin A2|proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.|24-hour urine and morning spot urine|The subjects included 5 generally healthy premenopausal women, age 20-40 y, with a body mass index (BMI) ranging from 18.5 to 25 kg/m2. The specific operational criteria used to assess eligibility included: age, BMI, premenopausal status, not pregnant or planning to become pregnant.||ng/mg creatinine||Standard Deviation|Mean
24782|NCT01687101|Primary|Efficacy of STOPAIN in the Acute Treatment of Migraine|"To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to no pain) at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain)."|At the time of applying gel|||units on a scale||Full Range|Mean
24783|NCT01687088|Primary|Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points|"Migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. The UPSIT test is a series of 40 questions and the score is the number of questions answered correctly. Each question is multiple choice and must be answered. The number of correct answers regarding the smells being experienced is the subjects score. The higher the score the better the sense of smell. This allows groups to be compared. In this study after the first visit, migraineurs will be given the UPSIT test without a headache and then they will self-administer the UPSIT during a migraine attack day at home.~Age and sex matched controls will also take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home."|Chronic migraineurs up to 12 months. Controls up to 2 weeks.|||UPSIT Score||Standard Error|Mean
24784|NCT01687036|Secondary|AE|18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013|||participants|||Number
24785|NCT01687036|Secondary|Cumulative Cryoablation Time|"Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.~Average cryoablation time was 114 min. 33 sec. (range 80 – 130 min.)."|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013|||minutes||Standard Deviation|Mean
24786|NCT01687036|Secondary|Fluoroscopy Time|"Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.~Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. – 59 min.)."|Treatment Duration|||minutes||Standard Deviation|Mean
31082|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7|Change from baseline in morning pre-dose trough FEV1|Day 7|MITT||Milliliters||95% Confidence Interval|Least Squares Mean
24787|NCT01687036|Secondary|Procedure Time|Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.|Average procedure time: 251 min. 06 sec. (range 126 – 320 min.)|||minutes||Standard Deviation|Mean
24788|NCT01687036|Secondary|Clinical Efficacy of Catheter Ablation|During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013|||participants|||Number
24789|NCT01687036|Secondary|Acute Efficacy of Catheter Ablation|Absolute percentage of PVs isolated with the CoolLoop® catheter.|Treatment Duration|||percentage of isolated PVs|||Number
24790|NCT01687036|Secondary|Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.|Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.|Treatment Duration|||participants|||Number
24791|NCT01687036|Primary|Tolerability of Ablation Using the AFreeze Cryoablation System|"The primary study objective is assessed by recording all Adverse Events (AEs).~Primary endpoint: measurement of the following parameters:~- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment)."|Treatment Duration|||AE (device related)|||Number
24792|NCT01687036|Primary|Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)|"The primary study objective is assessed by recording all Serious Adverse Events (SAEs).~Primary endpoint: measurement of the following parameters:~deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).~phrenic nerve palsy during visit 3 (treatment).~onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.~onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention."|3 months|||participants|||Number
24793|NCT01686932|Secondary|Number of Occurrence of Pre-defined ECG Findings During 4 Days of Continuous ECG Monitoring at Baseline and in the 8th Week of Periods 1 and 2|Number of Occurrence of pre-defined ECG findings during 4 days of continuous ECG monitoring at baseline and in the 8th week of Periods 1 and 2. ECG data were continuously recorded and analyzed over a period of 4 days simultaneously with continuous glucose monitoring. It assessed number of any Vertical Electric(al) Sounding (VES), number of 2 consecutive VES [couplets], and number of >3 consecutive VES [salves]|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||number of occurrence||Standard Deviation|Mean
24794|NCT01686932|Secondary|Percentage Change From Baseline of Pro-insulin/C-peptide Ratios After 8 Weeks of Treatment Period 1 & Period 2|Percentage Change from baseline of pro-insulin/C-peptide ratios after 8 weeks of treatment Period 1 & Period 2 Higher pro-insulin / C-peptide ratios (expressing disproportional hyperproinsulinemia) may be associated with increasing beta cell dysfunction and more inefficient pro-insulin processing|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||Percentage Change||Standard Deviation|Mean
24795|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers Interleukin 6 (IL-6) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers IL-6 was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||pg/L||Standard Deviation|Mean
24796|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers High Sensitivity C-reactive Protein (hsCRP) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers hsCRP was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||mg/L||Standard Deviation|Mean
24797|NCT01686932|Secondary|Number of Participants With ECG Abnormalities Depending on Hypoglycemic Events After 8 Weeks of Treatment Period 1 & Period 2|ECG abnormalities are defined as either: • Occurrence of >30 ventricular extrasystoles (VES) per hour or • Occurrence of ≥2 consecutive VES (Couplets) or • Occurrence of ≥3 consecutive VES (Triplets) or • QT-time corrected for heart rate (QTc) >440 ms. after 8 weeks of treatment Period 1 & Period 2|after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||participants|||Number
24798|NCT01686932|Secondary|Glucose Fluctuations During the Day Under Vildagliptin Treatment Compared to Sitagliptin Treatment on Day 2 After 8 Weeks of Treatment Period 1 & Period 2|Glucose fluctuations are assessed by the mean amplitude of glycemic excursions (MAGE) and standard deviations (SD) (Service et al., 1970). on day 2 after 8 weeks of treatment Period 1 & Period 2|Day 2 after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||mmol/L||Standard Deviation|Mean
24799|NCT01686932|Secondary|Number of Severe Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment After 8 Weeks of Treatment in Period 1 and Period 2|Severe hypoglycemic events are defined as any episode requiring the assistance of another party or measured plasma glucose levels of <40 mg /dL. Assessed by self-monitored blood glucose (SMBG)After 8 weeks of treatment in Period 1 and Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||severe hypoglycemic events|||Number
24800|NCT01686932|Secondary|Mean Amplitudes of Hypoglycemic Events (mmol/L) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|To evaluate by CGM measurement the grade of severity of hypoglycemia measured as the mean amplitude over 4 days after 8 weeks of treatment in Period 1 & Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||mmol/L||Standard Deviation|Mean
24826|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4|||mmol/L||Standard Deviation|Mean
24801|NCT01686932|Secondary|Mean Duration of Hypoglycemic Events (Min.) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|the mean duration of hypoglycemic events is detected by continuous glucose monitoring (CGM)measurement.|after 8 weeks for Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||minutes||Standard Deviation|Mean
24802|NCT01686932|Secondary|Number of Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment.|Hypoglycemic events are defined as blood glucose values <70 mg/dL measured by a self-monitored blood glucose (SMBG) or continuous glucose monitoring (CGM) measurement regardless of any symptoms suggestive of low blood glucose.|after 8 weeks period 1 and Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.||number of hypoglycemic events|||Number
24803|NCT01686932|Primary|Hypoglycemic Profile of Vildagliptin Compared to Sitagliptin Over 4 Days After 8 Weeks of Treatment in Period 1 & 2|The hypoglycemic profile is defined as the area under the curve glucose-time profile obtained by continuous glucose monitoring Interstitial glucose values below 3.9 mmol/L (averaged over 5 minutes) were considered relevant for the estimation of the interstitial glucose AUC in the hypoglycemic range These AUC<3.9mmol/L/5min. values were summed up over 4 days (unit: mmol/L/4d) or over 24 hours at measurement Days 2, 3, 4, and 5 (unit: mmol/L/24h). Lower values for AUC reflect less intense hypoglycemia.|baseline and 0-24 hours post-dose on Days 2 to 5|Full Analysis Set (FAS) included all patients that was treated with study medication.||mmol/L/4d||Standard Deviation|Mean
24804|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the Divided Attention task, participants were required to respond on hearing the no. ‘8’ in a continuous stream of numbers through headphones or seeing a letter ‘s’ on screen. This was identified in the output file by a value of ‘8’ in ‘NUMBER’ column or ‘s’ in ‘LETTER’ column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of ‘-1’ in ‘CORRECT=1’ column. The number of incorrect responses was calculated as the total no. of records where ‘CORRECT=1’ had a value of ‘-1’. If the subject missed a target (failed to press the response button on hearing the no. ‘8’ or seeing the letter ‘s’), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of ‘8’ in ‘NUMBER’ column or ‘s’ in ‘LETTER’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||incorrect and missed responses||Standard Error|Mean
24805|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Least Squares Mean
24806|NCT01686646|Secondary|Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number ‘8’ in a continuous stream of numbers presented through headphones or saw a letter ‘s’ on the screen . This was identified in the output file by a value of ‘8’ in the ‘NUMBER’ column or by a value of ‘s’ in the ‘LETTER’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Full Range|Median
24807|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|For sustained auditory attention task, participants were required to respond on hearing the no. ‘8’ in a continuous stream of numbers through headphones. It was identified in output file by a value of ‘8’ in ‘NUMBER’ column. For sustained visual attention task, participants responded to letter ‘s’ every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of ‘s’ in ‘LETTER’ column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of ‘-1’ in ‘CORRECT=1’ column. The no. of incorrect responses was calculated as total no. of records where ‘CORRECT=1’ had a value of ‘-1’. The no. of missed responses (when subject failed to press the response button on hearing the number ‘8’ or seeing the letter ‘s’), was calculated as the no. of records where there was a value of ‘8’ in ‘NUMBER’ column or ‘s’ in the ‘LETTER’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||incorrect and missed responses||Standard Error|Mean
24808|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Least Squares Mean
24827|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4|||U/L||Standard Deviation|Mean
24828|NCT01686451|Other Pre-specified|Comparison of XueZhiKang With Simvastatin of Physical Activity Level|At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.|Measured at baseline and week 4|||participants|||Number
24809|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number ‘8’ in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of ‘8’ in the ‘NUMBER’ column. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of ‘s’ in the ‘LETTER’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Full Range|Median
24810|NCT01686646|Secondary|Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task|The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of ‘1’ in the ‘TARGET=1’ column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of ‘-1’ in the ‘CORRECT=1’ column. The no. of incorrect responses was calculated as the total no. of records where ‘CORRECT=1’ had a value of ‘-1’. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of ‘1’ in the ‘TARGET=1’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||inaccurate and missed responses||Standard Error|Mean
24811|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and upto 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||milliseconds (msec)||Full Range|Median
24812|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of ‘1’ in ‘TARGET=1’ column. Also, the response time (in seconds) was recorded in the ‘RT’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Standard Error|Least Squares Mean
24813|NCT01686646|Primary|Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of ‘1’ in ‘TARGET=1’ column. Also, the response time (in seconds) was recorded in the ‘RT’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.||Correct responses||Standard Error|Least Squares Mean
24814|NCT01686633|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
24829|NCT01686451|Primary|Comparison Between XueZhiKang and Simvastatin on Fatigue Scores|At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.|Measured at baseline and week 4|||units on a scale||Standard Deviation|Mean
26921|NCT01656161|Secondary|Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337||Baseline through Day 337|ITT population with a measured value at each specified time point||percentage of change in PSA levels||Standard Deviation|Mean
24815|NCT01686633|Secondary|Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
24816|NCT01686633|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
24817|NCT01686633|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
24818|NCT01686633|Secondary|Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on-treatment. Change from Baseline in trough FEV1 at the end of the 12-week treatment period was defined using the 24-hour post-dose serial FEV1 measurement taken at the Week 12 clinic visit. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 12|ITT Population. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
24819|NCT01686633|Primary|Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 84/Week 12 minus the Baseline value. Baseline was the pre-dose FEV1 measurement value obtained at Visit 3. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and Week 12 weighted mean data were analyzed.||Liters||Standard Error|Least Squares Mean
24820|NCT01686568|Secondary|Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up|Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.|Baseline, after 6 months of treatment|||pmol/s/mg tissue||Standard Error|Mean
24821|NCT01686568|Secondary|Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up|Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.|baseline, after 6 months of treatment|||nmol/L||Standard Error|Mean
24822|NCT01686568|Primary|Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up|A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.|Baseline, after 6 months of treatment|||mg/kg FFM/min||Standard Error|Mean
24823|NCT01686503|Secondary|Baseline Polio Neutralizing Antibody Titers|serum polio neutralizing antibody titers prior to the vaccine booster|first visit|||antibody titers||95% Confidence Interval|Geometric Mean
24824|NCT01686503|Primary|Post Booster Polio Neutralizing Antibody Titers|Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.|4-6 weeks after receiving the vaccine|||antibody titers||95% Confidence Interval|Geometric Mean
24831|NCT01685983|Primary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Baseline, Month 4|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Percentage of participants|||Number
24832|NCT01685983|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|up to 15 months|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Participants|||Number
24833|NCT01685983|Secondary|Dehydroepiandrosterone (DHEA) Sulfate||Baseline up to 15 months|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."||micromol per liter||Full Range|Median
24834|NCT01685983|Secondary|Serum Testosterone|Median baseline testosterone concentration was reported at baseline.|Baseline up to 15 months|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."||nanomole per liter||Full Range|Median
24835|NCT01685983|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|up to 15 months|Radiographic response-evaluable population included all participants who received at least 1 dose of abiraterone acetate, and had baseline and at least 1 on treatment tumor assessment.||Percentage of participants|||Number
24836|NCT01685983|Secondary|Time to PSA Progression|Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.|up to 15 months|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Days||95% Confidence Interval|Median
24837|NCT01685983|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of the first dose to the date of death.|up to 5 years|Analysis population included all participants who received at least 1 dose of abiraterone acetate.||Days||95% Confidence Interval|Median
24838|NCT01685801|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) that started (or increased in severity) from first dose of study drug through completion of Follow-up were considered TEAEs, with exception that if an AE started during a Washout Period and was beyond 14 days from last dose date of preceding cycle, AE was considered as a “Washout Period” AE, and hence not TEAE. A TEAE was attributed to treatment in which it started or to the treatment in second cycling period of previous Crossover Period if it started during a Washout Period. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Data was to be reported by drug treatment for double-blind crossover period (Cycle 1 up to Washout Period 2) and open-label period.|From first dose of study drug through completion of follow-up visit (up to 26 weeks)|Safety set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies participant evaluable for this outcome measure.||participants|||Number
24839|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Weight at Day 57|Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||kilograms (kg)||Standard Deviation|Mean
24840|NCT01685801|Secondary|Open-label Period: Absolute Change From Study Baseline In Sweat Chloride at Day 57|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Study Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||millimole per liter (mmol/L)||Standard Deviation|Mean
24841|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Lung Clearance Index (LCI) at Day 57|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||ratio||Standard Deviation|Mean
25012|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 86|Analysis was done on Safety Set Unsolicited AEs||Subjects|||Number
24842|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) at Day 57|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."||Percent predicted of FEV1||Standard Deviation|Mean
24843|NCT01685801|Secondary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Lung Clearance Index (LCI) After 2 Weeks of Treatment|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."||ratio||Standard Deviation|Mean
24844|NCT01685801|Primary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) After 2 Weeks of Treatment|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"Full analysis set (FAS) population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."||Percent predicted of FEV1||Standard Deviation|Mean
24845|NCT01685606|Secondary|To Evaluate the Rate of Dose Limiting Toxicities of HLA Haploidentical Peripheral Blood Pheresed Cellular Infusions.||30 days and 16 weeks after infusion|||participants|||Number
24846|NCT01685606|Primary|Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.|"Criteria for AML and ALL (adapted from Cheson et al.20)~Complete remission (CR) is defined as the presence of all of the following~Peripheral blood~o No leukemic blasts present.~No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)~Bone marrow~Cellularity >20% with baseline maturation.~No Auer rods~Less than 5% blast cells.~Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC > 1.0 x 109/L and platelet count > 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free.~Complete remission with incomplete recovery (CRi) is defined as the following:~Meets criteria for CR except~ANC < 1.0 x 109/L or platelet count < 100x109/L~Partial remission (PR).~• Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts."|8 weeks after infusion then 6 months after and every 4 months for approximately 2 years|||participants|||Number
24847|NCT01685437|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.||centimeters||Standard Deviation|Mean
24848|NCT01685437|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.||participants|||Number
24849|NCT01685437|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
24850|NCT01685437|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
24851|NCT01685437|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.||participants|||Number
24852|NCT01685437|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
25393|NCT01675453|Secondary|Fluid Balance|Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.|24 hours||||||
24853|NCT01685437|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
24854|NCT01685437|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
24855|NCT01685437|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on modified intent-to-treat (mITT) population.||percentage of curvature change||Standard Deviation|Mean
24856|NCT01685320|Secondary|Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation|Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.|On average 20 seconds|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.||seconds||Standard Deviation|Mean
24857|NCT01685320|Primary|Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.|The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.|Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.||Newton||Standard Deviation|Mean
24858|NCT01685216|Secondary|Number of Participants Who Developed Anti-Velaglucerase Alfa Antibodies During The Study|Participants provided blood samples for measurement of anti-velaglucerase alfa antibodies in serum at baseline and approximately every 12 weeks during the treatment phase. Blood samples collected during the treatment phase were to be drawn prior to infusions. Analysis of anti-velaglucerase antibodies used a validated 3-tier immunoassay method (screening, confirmatory, and titer).|Baseline, Weeks 13, 25, 37 and 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||participants|||Number
24859|NCT01685216|Secondary|Number of Participants Who Experienced a Treatment-Emergent Adverse Event|Adverse events (AEs) were monitored continuously throughout the study from the time the participant or participants parent/legal guardian signed the informed consent/assent (if applicable) until 30 days after the participant’s last dose of study drug or at the end of study visit and/or until the event resolved or stabilized, or an outcome had been reached, whichever came first. Treatment-emergent adverse events (TEAEs) were defined as AEs which occurred on or after the time of the first infusion until 30 days after the participant’s last study infusion. An infusion-related reaction is defined as an AE that 1) began either during or within 12 hours after the start of the infusion, and 2) was judged as possibly or probably related to study medication.|57 weeks|The Safety Analysis population, defined as all participants who received at least 1 study drug infusion (full or partial).||participants|||Number
24860|NCT01685216|Secondary|Number of Participants With Abnormal Neurological Status During The Study|Neurological symptoms were evaluated at regular intervals during the study and assessed on an individualized basis by a limited, age- and developmental stage-appropriate neurological examination adapted to suit the status of each participant. It was preferred that each neurological examination be performed by a neurologist with experience in assessment of neurological symptoms in patients with Gaucher disease and, if possible, the same neurologist (or designee) who evaluated a given participant at baseline performed the neurological examinations scheduled for that participant during the treatment phase and at the end of study visit.|Baseline, Weeks 13, 25, 37, and 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||participants|||Number
24861|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Spleen Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure spleen volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, spleen volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The spleen size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in spleen volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that spleen volume decreased.|Baseline, Week 51|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||percent change||Standard Deviation|Mean
24862|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Liver Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure liver volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, liver volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The liver size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in liver volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that liver volume decreased.|Baseline, Week 51 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||percent change||Standard Deviation|Mean
25394|NCT01675453|Secondary|Cardiac Index||24 hours||||||
25395|NCT01675453|Secondary|Oxygen Delivery|Oxygen delivery index (DO2I) will be used to assess this outcome measure.|24 hours||||||
24863|NCT01685216|Secondary|Change From Baseline to 12 Months (Week 53) in Platelet Count|Platelet count was measured at a central laboratory as part of the hematology panel. Baseline is the modified baseline platelet count, the average of the values from screening, baseline and Week 1/Day 1. A positive change from baseline indicates that platelet count increased.|Baseline, Week 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||platelets (x10^9)/L||Standard Deviation|Mean
24864|NCT01685216|Primary|Change From Baseline to 12 Months (Week 53) in Hemoglobin Concentration|Hemoglobin concentration was measured as part of the hematology panel or measured separately when the hematology panel was not scheduled. Samples were measured by a central laboratory. Baseline is the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1/Day 1. A positive change from baseline indicates that hemoglobin concentration increased.|Baseline, Week 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).||g/dL||Standard Deviation|Mean
24865|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events|Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.|From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.|All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
24866|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA < LLOQ at the final treatment visit.||Percentage of participants||95% Confidence Interval|Number
24867|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
24868|NCT01685203|Primary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
24869|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
24870|NCT01684930|Secondary|Change in Angiogenesis|Gastrocnemius muscle biopsy will be performed to measure markers of angiogenesis including; capillaries per unit area and per muscle fiber, endothelial cells with surrounding pericytes, relative fraction of type I, IIa, IIb, and IId/x fibers. If differences exist we will look for changes in cell proliferation (PCNA) and apoptosis (TUNEL); (b) oxidative capacity including; mitochondria volume with citrate synthase activity. (c) mitochondrial volume and density; (d) mitochondrial oxygen efficiency (respiratory control ratio, the ratio of ATP phosphorylation rate per oxygen consumption rate (P/O ratio), and maximal rate of ATP production). These are measurements for potential mediation analyses and gaining insight into the relative effect sizes will inform mechanistic aims in a larger trial.|Baseline and 16 weeks||||||
24871|NCT01684930|Primary|Change In Time To Exhaustion|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.|Baseline and 16 weeks|||seconds||Standard Deviation|Mean
24872|NCT01684930|Secondary|Change In Vascular Function|Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), calf blood flow (plethysmography), and arterial stiffness (pulse wave velocity and pulse wave reflection).|Baseline and 16 weeks||||||
24873|NCT01684930|Secondary|Change In Claudication Onset Time|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.|Baseline and 16 weeks|||seconds||Standard Deviation|Mean
24874|NCT01684930|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks|||feet||Standard Deviation|Mean
24875|NCT01684930|Primary|Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.|Baseline and 16 Weeks|All participants who completed study.||ml/kg/min||Standard Deviation|Mean
24933|NCT01683604|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
24876|NCT01684878|Secondary|Part 2: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|Safety population included all participants who had received at least 1 dose of pertuzumab, pertuzumab-placebo, or chemotherapy.||percentage of participants|||Number
24877|NCT01684878|Secondary|Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.|Baseline (assessed at baseline and every 9 weeks from randomization until disease progression)|ITT population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).||units on a scale||Standard Deviation|Mean
24878|NCT01684878|Secondary|Part 2: Progression-free Survival (PFS) Assessed by the Investigator|PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis)||months||95% Confidence Interval|Median
24879|NCT01684878|Secondary|Part 1: PFS Assessed by the Investigator|PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day.|Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.||months||95% Confidence Interval|Median
24880|NCT01684878|Secondary|Part 2- Objective Response Rate (ORR)|ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression)|ITT population with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
24881|NCT01684878|Secondary|Part 1- Objective Response Rate (ORR)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression)|All Treated participants with measurable disease at baseline.||percentage of participants|||Number
24882|NCT01684878|Primary|Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)|PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population was defined as all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).||months||95% Confidence Interval|Median
24883|NCT01684878|Primary|Part 1: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.||percentage of participants|||Number
24884|NCT01684839|Other Pre-specified|Tinel’s Sign|Tinel’s sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma|20-26 months postoperatively||||||
24885|NCT01684839|Secondary|Cold Intolerance Severity Score (CISS) Questionnaire|The maximum score was 100 and was grouped into 4 ranges (0–25; 26–50; 51–75; and 76–100), corresponding to mild, moderate, severe, and extreme severity, respectively.|20-26 months postoperatively||||||
24886|NCT01684839|Primary|Static 2-point Discrimination Test|The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6–10 mm; fair 11–15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.|20-26 months postoperatively|||mm||Standard Deviation|Mean
24887|NCT01684826|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)||percentage of dose change||Standard Deviation|Mean
24888|NCT01684826|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)||percentage of dose change||Standard Deviation|Mean
24889|NCT01684826|Primary|Image Quality|"Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.~The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used."|1 day|All patient with recorded dose information and images for both angiograms were used.||proportion of readers||90% Confidence Interval|Mean
24890|NCT01684748|Other Pre-specified|Proinflammatory and Collagen Gene Expression in Skeletal Muscle||8 weeks||||||
24891|NCT01684748|Primary|Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)|Data collected from the intravenous glucose tolerance tests included blood concentrations of glucose and insulin. Glucose was measured immediately on a YSI glucose analyzer and insulin was measured via ELISA colormetric kits once all study samples were collected. To analyze changes in insulin sensitivity, the MINMOD software was used. The MINMOD software uses Bergman's minimal model to determine insulin sensitivity during an intravenous glucose tolerance test. Both glucose and insulin values were inserted at each timepoint collected (33 in total over the 3-hour protocol) and the software was run to generate the insulin sensitivity value at baseline and post-test. This information was then used to calculate the change of insulin sensitivity from baseline to post-testing after each 8-week intervention.|Baseline testing to post-testing after 8-week intervention|Results of insulin sensitivity by intravenous glucose tolerance (IVGTT) testing are reported per intervention (Olmesartan Medoxomil and No drug). Only 10 of the 16 study participants who participated in all or some of the study measurements opted to complete or had sufficient data to analyze for each pre- and post-intervention (4 total) IVGTT.||mu/L/min||Standard Deviation|Mean
24892|NCT01684748|Primary|CD68 Gene Expression by Immunohistochemistry of Adipose Tissue||8 weeks||||||
24893|NCT01684566|Secondary|Duration of Oral Mucositis, Per Protocol Population|Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis is graded according to the 5-point oral mucositis WHO scale Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible|28 days|Per Protocol (PP). There were 9 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis||Days||Standard Deviation|Mean
24894|NCT01684566|Secondary|Occurence of Oral Mucositis, Per Protocol Population|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organisation) oral toxicity scale grade 0-4~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP)||participants|||Number
24895|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores AUC Over the 28-Day Period Per protocol population.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP) without Last observation carried over(LOCF)||score||Standard Deviation|Mean
24896|NCT01684566|Secondary|Hospital Stay, Days|Duration of hospital stay (time from admission to discharge)|28 days|Intention to treat (ITT) Hospital stay, days||Days||Standard Deviation|Mean
24897|NCT01684566|Secondary|Oral Mucositis Assessment Scale (OMAS)|"Summary of Oral Mucositis Assessment Scale (OMAS) Ulceration and Erythema Scores Extent of ulceration (grade 0-3) and severity of erythema (grade 0-2) according to the OMAS (Oral Mucositis Assessment Scale) assessed by a dental practitioner twice-weekly over the 28-day study period.~The extent of ulceration was rated as follows:~0 no lesion~1 cm2~1-3 cm2~>3 cm2~The severity of erythema was assessed as follows:~0 none~not severe~severe"|28 days|Intention to treat (ITT) Ulceration and Erythema.OMAS was only performed in sites were a dentist was available therefore lower numbers in the analysis.||score||Standard Deviation|Mean
24898|NCT01684566|Secondary|Oral Mucositis Daily Questionnaire (OMDQ)|OMDQ (Oral Mucositis Daily Questionnaire) scale was used to measure Overall Mouth and Throat Soreness This was scored from 0=no soreness to 10=worst possible soreness.|28 days|Intention to treat(ITT) OMDQ AUC over time. Not all patients reported data from OMDQ therefore there is lower number of patients in this analysis.||units on a scale||Standard Deviation|Mean
25396|NCT01675453|Secondary|Pulmonary Oxygenation|Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.|24 hours||||||
24899|NCT01684566|Secondary|Duration of Oral Mucositis, Intention to Treat Population|"Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis was graded according to WHO 5 Point grading scale on a daily basis.~Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|ITT (Intention to treat). There were13 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis||Days||Standard Deviation|Mean
24900|NCT01684566|Secondary|Occurrence of Oral Mucositis|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organization) oral toxicity scale grade 0-4.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT)||participants|||Number
24901|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores Area under the curve (AUC) over the 28-Day Period ITT Populations.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT) and Last observation carried forward (LOCF)||score||Standard Deviation|Mean
24902|NCT01684436|Primary|Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 3|All patients who completed the study||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
24903|NCT01684436|Secondary|Dry Eye Questionnaire Irritation Score|Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms.|Week 0 (Baseline), Week 3|All patients who completed the study||Millimeters (mm)||Standard Deviation|Mean
24904|NCT01684436|Secondary|Schirmer's Test Score|The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Week 0 (Baseline), Week 3|All patients who completed the study||Millimeters (mm)||Standard Deviation|Mean
24905|NCT01684436|Secondary|Tear Film Break-up Time (TBUT)|TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.|Week 0 (Baseline), Week 3|All patients who completed the study||Seconds||Standard Deviation|Mean
24906|NCT01684436|Secondary|Corneal Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.|Week 0 (Baseline), Week 3|All patients who completed the study||Scores on a Scale||Standard Deviation|Mean
24907|NCT01684436|Primary|Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 0 (Baseline)|All patients who completed the study||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
24908|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 3|FVC conducted before and after inhalation of the investigational product|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)||percent||Standard Deviation|Mean
24909|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|FEV1 conducted before and after inhalation of the investigational product at study visits.|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)||percent||Standard Deviation|Mean
24910|NCT01684410|Primary|Adverse Events|adverse event frequency|3 weeks|Safety Population: included all subjects who received any dose of IP (included those withdrawn from treatment for any reason)||percentage of participants|||Number
24911|NCT01684046|Primary|Subjective Lens Wear Comfort|"Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, When I use this solution, I can comfortably wear my lenses, with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree."|Day 30|This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.||units on a scale||Standard Deviation|Mean
24912|NCT01684033|Primary|Change From Baseline in Corneal Staining at Day 30|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Baseline (Day 0), Day 30|||units on a scale||Standard Deviation|Mean
24913|NCT01684033|Primary|Corneal Staining|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Day 30|This analysis population group includes all participants who were exposed to both treatment regimens.||Units on a scale||Standard Deviation|Mean
24914|NCT01684007|Secondary|Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)|VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.||logMAR||Standard Deviation|Mean
24915|NCT01684007|Primary|Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)|Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.||logMAR||Standard Deviation|Mean
24916|NCT01683838|Secondary|Adjusted Mean Change in Subject Bowel Function Diary Scores|"Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.~A negative change in patient bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||minutes||Standard Error|Mean
24917|NCT01683838|Secondary|Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores|"Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.~A negative change in patient bladder/bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||episodes||Standard Error|Mean
24918|NCT01683838|Secondary|Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores|"The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).~A positive change signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98|||units on a scale||Standard Error|Mean
24919|NCT01683838|Secondary|Change From Baseline in Mean International Index of Erectile Function (IIEF) Score|"Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.~Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98|ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.||units on a scale||Standard Error|Mean
24920|NCT01683838|Secondary|Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score|Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.|Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.||units on a scale||Standard Error|Mean
24921|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores|The supervising clinician rated the patient’s neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician’s overall impression of the patient’s neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.|Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
24959|NCT01683604|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation|Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.|Month 6|FAS population||percentage of participants|||Number
24960|NCT01683526|Secondary|Complications of Intubation|Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.|For 10 minutes post intubation|||percentage of other complications|||Number
24961|NCT01683526|Secondary|Cardiac Arrest||For 1 hour post intubation|||percentage of cardiac arrest|||Number
24922|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores|"The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.~The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.~On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
24923|NCT01683838|Primary|Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores|"The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.~The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
24924|NCT01683838|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|"The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:~1=no increased tone; 2=slight increase in tone, giving a catch when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.~The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.||units on a scale||Standard Error|Mean
24925|NCT01683630|Primary|Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba||Upto 15 years|||percentage of participants|||Number
24926|NCT01683630|Primary|Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba||upto 15 years|||Percentage of participants|||Number
24927|NCT01683630|Primary|Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba||up to 15 years|||Percentage of participants||95% Confidence Interval|Number
24928|NCT01683604|Secondary|Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
24929|NCT01683604|Secondary|Change From Baseline in Patient's Assessment of Pain at Months 3 and 6|Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.||mm||Standard Deviation|Mean
24930|NCT01683604|Secondary|Change From Baseline in VAS-Fatigue at Months 3 and 6|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
24931|NCT01683604|Secondary|Change From Baseline in HAQ-DI Score at Months 3 and 6|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ­D1 score reported at baseline and the HAQ­D1 score reported at Month 3 and Month 6.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.||units on a scale||Standard Deviation|Mean
24932|NCT01683604|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||mm||Standard Deviation|Mean
24962|NCT01683526|Secondary|Hypotension|SBP<70|For 10 minutes post intubation|||percentage of hypotension|||Number
24963|NCT01683526|Secondary|Severe Desaturation|sat <80%|For 10 minutes post intubation|||percentage of patients with desaturation|||Number
24934|NCT01683604|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment|ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.||percentage of participants||95% Confidence Interval|Number
24935|NCT01683604|Secondary|Simplified Disease Activity Index (SDAI) Score by Visit|The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.||units on a scale||Standard Deviation|Mean
24936|NCT01683604|Secondary|Change From Baseline in TJC and SJC at Month 3 and Month 6|TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||joint counts||Standard Deviation|Mean
24937|NCT01683604|Secondary|Clinical Disease Activity Index (CDAI) Score by Visit|The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.||units on a scale||Standard Deviation|Mean
24938|NCT01683604|Secondary|Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c­reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.||percentage of participants|||Number
24939|NCT01683604|Secondary|Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit|The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.||units on a scale||Standard Deviation|Mean
24940|NCT01683604|Secondary|Percentage of Participants Adhering to Local Label for Adverse Events|Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.|Baseline up to Month 6|FAS population. Number of participants analyzed = participants with available data for this outcome measure.||percentage of participants|||Number
24964|NCT01683526|Primary|First Pass Success Rate||From begining of intubation to verification. Less then 5 minutes approximatly|||percentage of first pass success|||Number
24941|NCT01683604|Secondary|Percentage of Participants With and Without Morning Stiffness|"Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:~Presence of participant's joints stiff when woke up that day, measured as yes or no~Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: < 30 minutes, between 30 and 240 minutes, > 240 minutes, and the whole day.~Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness."|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.||percentage of participants|||Number
24942|NCT01683604|Secondary|Percentage of Participants by Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (<) 30 minutes, between 30 and 240 minutes, greater than (>) 240 minutes and whole day.|Baseline, Month 3, Month 6|FAS population. Here, n= participants with available data at specified visit.||percentage of participants|||Number
24943|NCT01683604|Secondary|Duration of Tocilizumab Treatment||Baseline up to Month 6|FAS population.||days||Standard Deviation|Mean
24944|NCT01683604|Secondary|Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6||Baseline, Month 6|FAS population. n= participants with available data at the specified visit.||percentage of participants|||Number
24945|NCT01683604|Secondary|Percentage of Participants by Reason for Choice of Monotherapy at Baseline||Baseline up to Month 6|Analysis was not performed as the data was not collected on case report form.|||||
24946|NCT01683604|Secondary|Time to Restoration of Initial Dosing Regimen||Baseline up to Month 6|Analysis was not performed due to inadequate data available for this outcome measure.|||||
24947|NCT01683604|Secondary|Percentage of Participants With Reasons Who Discontinued Tocilizumab||Baseline up to Month 6|FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.||percentage of participants|||Number
24948|NCT01683604|Secondary|Mean Dosing Interval at Month 6|The time interval between two successive doses in days was reported.|Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||days||Standard Deviation|Mean
24949|NCT01683604|Secondary|Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change|Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.|Baseline up to Month 6|FAS population.||percentage of participants|||Number
24950|NCT01683604|Secondary|Median Dose at Month 6||Month 6|FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.||milligram per kilogram (mg/kg)||Full Range|Median
24951|NCT01683604|Secondary|Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs||Baseline|FAS population.||percentage of participants|||Number
24952|NCT01683604|Primary|C-Reactive Protein (CRP) at Baseline|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline|FAS population.||milligrams per liter (mg/L)||Standard Deviation|Mean
24953|NCT01683604|Primary|Erythrocyte Sedimentation Rate (ESR) at Baseline|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||mm/hr||Standard Deviation|Mean
24954|NCT01683604|Primary|Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.||joint counts||Standard Deviation|Mean
24955|NCT01683604|Primary|Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
24956|NCT01683604|Primary|Physician Global Assessment of Disease Activity Using VAS at Baseline|Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||mm||Standard Deviation|Mean
24957|NCT01683604|Primary|Patient Global Assessment of Disease Activity Using VAS at Baseline|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||mm||Standard Deviation|Mean
24958|NCT01683604|Primary|Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline|Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||millimeters (mm)||Standard Deviation|Mean
24965|NCT01683383|Other Pre-specified|Safety Outcomes|The incidence, intervention and outcome of cardiac arrhythmia, major bleeding, altered skin integrity, pulmonary hypertension, device-related events, death, and other serious adverse events from the time of initiation of transport cooling to the time of completion will be monitored.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm||Participants|||Number
24966|NCT01683383|Secondary|Participants in Target Temperature Range Anytime During Transport|Participants in target temperature range (33-34 C) anytime during transport|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm||Participants|||Number
24967|NCT01683383|Secondary|Percentage of Participants in the Target Range at 1 Hour|Percentage of participants in target range (33°-34°C) one hour after cooling initiation by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm, excluding 8 participants in the control arm and 12 participants in the device arm who completed transport in < 1 hour.||Percentage of participants|||Number
24968|NCT01683383|Secondary|Time to Target Temperature|Time to the target temperature range (33°-34°C) from initiation of cooling by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm||Minutes||Standard Deviation|Mean
24969|NCT01683383|Primary|Percentage of Temperatures in Target Range During Transport|The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm||Percentage of temperatures||Inter-Quartile Range|Median
24970|NCT01683266|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
24971|NCT01683266|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.||units on a scale||Standard Error|Least Squares Mean
24972|NCT01683266|Secondary|Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.||U/kg||Standard Deviation|Mean
24973|NCT01683266|Secondary|Change in 8-­Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time­point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8­point SMPG assessment separately for each analysed time point.||mmol/L||Standard Deviation|Mean
24974|NCT01683266|Secondary|Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.||percentage of participants|||Number
24975|NCT01683266|Secondary|Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6||Month 6|mITT Population.||percentage of participants|||Number
24976|NCT01683266|Secondary|Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.||mmol/L||Standard Error|Least Squares Mean
24977|NCT01683266|Secondary|Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint|Pre­injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.||percentage of mean||Standard Error|Least Squares Mean
24978|NCT01683266|Secondary|Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint|Pre­injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
24979|NCT01683266|Secondary|Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint||Month 6|mITT Population.||percentage of participants|||Number
24980|NCT01683266|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population.||percentage of participants|||Number
24981|NCT01683266|Primary|Change In HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post­baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.||percentage of hemoglobin||Standard Error|Least Squares Mean
24982|NCT01683058|Secondary|Number of Participants With Clinically Relevant Physical Examination.|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant.||participants|||Number
24983|NCT01683058|Secondary|Number of Participants With Clinically Relevant Laboratory Values.|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study.||participants|||Number
24984|NCT01683058|Secondary|Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.|Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included.||cm||Standard Deviation|Mean
24985|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.|Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||Kg/m2||Standard Deviation|Mean
24986|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.|Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||Kg||Standard Deviation|Mean
24987|NCT01683058|Secondary|Mean Change in QTcN Interval From Baseline in All Participants.|The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
24988|NCT01683058|Secondary|Mean Change in QTcF Interval From Baseline in All Participants.|The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
24989|NCT01683058|Secondary|Mean Change in QTcB Interval From Baseline in All Participants.|The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
24990|NCT01683058|Secondary|Mean Change in QT Interval From Baseline in All Participants.|The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
24991|NCT01683058|Secondary|Mean Change in QRS Interval From Baseline in All Participants.|The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
24992|NCT01683058|Secondary|Mean Change in RR Interval From Baseline in All Participants.|The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
24993|NCT01683058|Secondary|Mean Change in PR Interval From Baseline in All Participants.|The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||msec||Standard Deviation|Mean
24994|NCT01683058|Secondary|Mean Change in Ventricular Rate From Baseline in All Participants.|The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||Beats/min||Standard Deviation|Mean
24995|NCT01683058|Secondary|Mean Change in Diastolic BP From Baseline in All Participants.|The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
24996|NCT01683058|Secondary|Mean Change in Systolic BP From Baseline in All Participants.|The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
24997|NCT01683058|Secondary|Mean Change in Heart Rate From Baseline in All Participants.|The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||beats/min||Standard Deviation|Mean
24998|NCT01683058|Secondary|Mean Change in Diastolic Supine BP From Baseline in All Participants.|The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
24999|NCT01683058|Secondary|Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.|The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||mmHg||Standard Deviation|Mean
25000|NCT01683058|Secondary|Mean Change in Heart Rate Supine From Baseline in All Participants.|The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||beats/min||Standard Deviation|Mean
25001|NCT01683058|Secondary|Mean Change in Body Temperature From Baseline in All Participants.|The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).||°C||Standard Deviation|Mean
25002|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)|The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
25003|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)|EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
25004|NCT01683058|Secondary|Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)|The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
25005|NCT01683058|Secondary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)|Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Units on a scale||Standard Deviation|Mean
25006|NCT01683058|Primary|Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death|A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.||Percentage of participants|||Number
25007|NCT01683019|Secondary|Safety Profile of the Treatment|Describe the safety profile of the administration of low-emission sinusoidal magnetic fields above the subject's scalp. Safety criteria include adverse events, serious adverse events, and vital signs.|Outcome assessed at the end of the 4th week of treatment.||||||
25008|NCT01683019|Primary|Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.|"Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.~The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression."|Assessed at baseline and the end of Week 4 of treatment.|52 subjects were randomized into the study. Of those, 7 dropped in the first week due to difficulties driving to the study site. An intent-to-treat analysis was performed on the remaining 45 subjects.||% change in HAM-D score||Standard Error|Mean
25009|NCT01682954|Primary|Body Weight|Change in body weight|7 Months|||kg||Standard Error|Mean
25010|NCT01682954|Primary|Body Weight|Change in body weight|4 months|||kg||Standard Error|Mean
25013|NCT01682876|Secondary|Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset||Subjects|||Number
25014|NCT01682876|Secondary|Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||subjects|||Number
25015|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset||Titers||95% Confidence Interval|Geometric Mean
25016|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset||percentages of subjects||95% Confidence Interval|Number
25017|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset||Titer||95% Confidence Interval|Geometric Mean
25018|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset.||percentage of subjects||95% Confidence Interval|Number
25019|NCT01682876|Primary|Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.|One Month After Last Vaccination (day 86)|Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.||percentage of subjects||95% Confidence Interval|Number
25020|NCT01682876|Primary|Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|"Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart.~Seroresponse is defined as:~postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4;~for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer."|One Month After Last Vaccination ( day 86)|Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||percentage of subjects||95% Confidence Interval|Number
25021|NCT01682863|Secondary|Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Number of puffs||Standard Error|Least Squares Mean
25022|NCT01682863|Secondary|Change From Baseline in Mean Total Daily Symptom Scores|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Score on a scale||Standard Error|Least Squares Mean
25023|NCT01682863|Secondary|Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation|Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis.||Percentage of participants|||Number
27962|NCT01640184|Secondary|Changes of Blood Levels on Phosphorus During 12 Months.|The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||mmol/L||Standard Deviation|Mean
25024|NCT01682863|Secondary|Change From Baseline in FVC Measurement at All Post-baseline Time Points|Pulmonary function assessments were performed using centralized spirometry according to international standards.|Day1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
25025|NCT01682863|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
25026|NCT01682863|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 29, 57,, 85, 141, 197, 253, 309 and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
25027|NCT01682863|Secondary|Time to Premature Discontinuation of Treatment|methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl|56 weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
25028|NCT01682863|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|56 weeks|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included.||Number of Patients|||Number
25029|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54|The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||Percentage of participants||95% Confidence Interval|Number
25030|NCT01682759|Secondary|Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue||Baseline and Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||kg||95% Confidence Interval|Least Squares Mean
25031|NCT01682759|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue|Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).|Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||Percentage of participants|||Number
25032|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||Percentage of participants||95% Confidence Interval|Number
25033|NCT01682759|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 54|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).|Baseline and Week 54|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
25034|NCT01682759|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue||Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||Percentage of participants|||Number
25035|NCT01682759|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 57|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.||Percentage of participants|||Number
27963|NCT01640184|Secondary|Changes of the Blood Levels on Calcium During 12 Months.|The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||mmol/L||Standard Deviation|Mean
25036|NCT01682759|Primary|Change From Baseline in Hemoglobin A1C at Week 54|Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.|Baseline and Week 54|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.||A1C (%)||95% Confidence Interval|Least Squares Mean
25037|NCT01682720|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group."|Up to Posttreatment Week 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.||percentage of participants|||Number
25038|NCT01682720|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.||percentage of participants|||Number
25039|NCT01682720|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
25040|NCT01682720|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.||percentage of participants|||Number
25041|NCT01682681|Secondary|Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More|Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.|Week 52|FAS population included all participants who met all the eligibility criteria.||Percentage of participants||95% Confidence Interval|Number
25042|NCT01682681|Secondary|Percentage of Participants Without Seizure|Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.||Percentage of participants||95% Confidence Interval|Number
25043|NCT01682681|Secondary|Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy|Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.||Participants|||Number
25044|NCT01682681|Secondary|Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)|Number of participants who received concomitant AEDs along with the topiramate were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.||Participants|||Number
25045|NCT01682681|Primary|Percentage of Participants Retained to Topiramate Treatment|Participants with long term retention of topiramate until 52 weeks were reported|Week 52|The full analysis set (FAS) population included all participants who met all the eligibility criteria.||Percentage of participants||95% Confidence Interval|Number
25046|NCT01682642|Secondary|Total Follicle Stimulating Hormone (FSH) Dose|total dose of FSH needed at the end of stimulation|3 weeks|||IUs||Standard Deviation|Mean
25047|NCT01682642|Other Pre-specified|Number of Days of Stimulation|number of days needed before follicles in the ovary are mature for oocyte retrieval|3 weeks|||days||Standard Deviation|Mean
25048|NCT01682642|Secondary|Number of Cryopreserved Embryos|number of blastocytes that can be cryopreserved|1 week after oocyte retrieval|||number of cryopreserved embryos||Standard Deviation|Mean
25049|NCT01682642|Secondary|Number of Pro Nuclear Cell (2PN)|number of 2PN|1 day after oocyte retrieval|||number of pro nuclear cells||Standard Deviation|Mean
25050|NCT01682642|Secondary|Good Embryo Quality|The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.|3 days after oocyte retrieval|||percentage of good quality embryos|||Number
25051|NCT01682642|Secondary|Pregnancy Rate|The number of ongoing pregnancies obtained which still is the most important issue for the patients.|12 weeks|||percentage of ongoing pregnancies|||Number
25052|NCT01682642|Primary|Number of Metaphase II Cells (MII)|number of MII cells retrieved|3 weeks|||MII cells||Standard Deviation|Mean
25053|NCT01682603|Other Pre-specified|Autonomic Dysreflexia||Baseline and 12 months|||participants|||Number
25054|NCT01682603|Primary|Net Change of the Quality of Life Index (QoL-I)|"Efficacy:~Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 Delighted to 6 Terrible. The QoL-I ranges 0 to 6~Safety:~Systemic adverse events"|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
25055|NCT01682603|Primary|Net Change of the Incontinence Impact Questionnaire (IIQ-7)|"Efficacy:~Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.~The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.~Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events"|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
25104|NCT01681576|Secondary|Cumulative Sodium Excretion (Natriuresis) at Day 28|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28|0-6 and 0-24 hours on Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmol||Standard Deviation|Mean
25056|NCT01682603|Secondary|Net Change of the Postvoid Residual Volume (PVR)|"Efficacy:~Net change of the postvoid residual volume (PVR) from baseline and 12 months~Results:~Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.~Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.~Safety:~Systemic adverse events"|Baseline and 12 months|||mL||Standard Deviation|Mean
25057|NCT01682603|Secondary|Net Change of the Detrusor Pressure (Pdet)|"Efficacy:~Net change of the detrusor pressure (Pdet) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months|||cmH2O||Standard Deviation|Mean
25058|NCT01682603|Secondary|Net Change of the Void Volume|"Efficacy:~Net change of the void volume from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months|||mL||Standard Deviation|Mean
25059|NCT01682603|Secondary|Net Change of the Maximum Flow Rate (Qmax)|"Efficacy:~Net change of the maximum flow rate (Qmax) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months|||mL/s||Standard Deviation|Mean
25060|NCT01682603|Secondary|Net Change of the Bladder Compliance|"Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.~Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).~Efficacy:~Net change of the bladder compliance from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months|||mL/cmH2O||Standard Deviation|Mean
25061|NCT01682603|Secondary|Net Change of the Cystometric Bladder Capacity (CBC)|"Efficacy:~Net change of the cystometric bladder capacity (CBC) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months|||mL||Standard Deviation|Mean
25062|NCT01682603|Primary|Net Change of the Urinary Distress Inventory (UDI-6)|"Efficacy:~Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.~The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.~The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events"|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
25063|NCT01682538|Secondary|Apparent Volume of Distribution (Vz/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||L||Full Range|Median
25064|NCT01682538|Secondary|Oral Clearance (CL/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||L/h||Full Range|Median
25065|NCT01682538|Secondary|Terminal Half-life|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||hours||Full Range|Median
25066|NCT01682538|Secondary|Time to Reach C-Max (t-Max)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)||hours||Full Range|Median
25067|NCT01682538|Secondary|AUC From Time Zero to Infinity|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per-protocol set (bioequivalence) was used for fasted treatment groups and per-protocol set (food effect) for fed treatment group (all subjects with available PK data)||h*uM||Full Range|Geometric Mean
25068|NCT01682538|Secondary|The Maximum Serum Concentration (Cmax)|Measured for the Orfadin suspension treatment arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||nM||Full Range|Geometric Mean
25069|NCT01682538|Secondary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h)|Measured for the Orfadin suspension treatments arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||uM*h||Full Range|Geometric Mean
25070|NCT01682538|Primary|The Maximum Serum Concentration (Cmax) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||nM||Full Range|Geometric Mean
25071|NCT01682538|Primary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.||uM*h||Full Range|Geometric Mean
25072|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)|1 month after using artificial tears|||units on a scale||Standard Deviation|Mean
25073|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)|1 week after using artificial tears|||units on a scale||Standard Deviation|Mean
25074|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100."|1 month after using artificial tears|||units on a scale||Standard Deviation|Mean
25075|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100."|1 week after using artificial tears|||units on a scale||Standard Deviation|Mean
25076|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)|At baseline (dispensing visit)|||units on a scale||Standard Deviation|Mean
25077|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100."|At baseline (dispensing visit)|||units on a scale||Standard Deviation|Mean
25078|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 month|||seconds||Standard Deviation|Mean
25079|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 week|||seconds||Standard Deviation|Mean
25080|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|At baseline (dispensing visit)|||seconds||Standard Deviation|Mean
25081|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 month|||units on a scale||Standard Deviation|Mean
25082|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 week|||units on a scale||Standard Deviation|Mean
25083|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|At baseline (dispensing visit)|||units on a scale||Standard Deviation|Mean
25084|NCT01682135|Secondary|Number of Participants With Best Objective Response (BOR)|Participants achieved disease control if they had a BOR of CR, PR or SD. Progressive Disease (PD) and those participants which were Not Evaluable (NE) were also reported. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug.||Participants|||Number
25085|NCT01682135|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion|All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data.||Participants|||Number
25086|NCT01682135|Secondary|Time to Disease Progression|Time to progressive disease was measured from the start of study drug until progressive disease. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. Censoring for Cohort 1, 2 and 3: 3, 2 and 2, respectively.||Months||95% Confidence Interval|Median
25087|NCT01682135|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug and had evaluable SD data. Participants censored for Cohort 1, 2, and 3: 3, 2, and 1, respectively.||Months||95% Confidence Interval|Median
25105|NCT01681576|Primary|Cumulative Sodium Excretion (Natriuresis) at Day 1|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1|0-6 and 0-24 hours on Day 1|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmol||Standard Deviation|Mean
25106|NCT01681511|Other Pre-specified|Organism Relation to CAUTI and TIC|Organisms found in relation to CAUTI events in TIC versus control.|up to 30th day from the time of catheterization|||participants|||Number
25205|NCT01680328|Secondary|Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.||scores|||Number
25088|NCT01682135|Secondary|Duration of Response|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant’s last objective tumor assessment prior to that cut-off date.|Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. There were no participants censored due to no CR or PR responses.||Months||95% Confidence Interval|Median
25089|NCT01682135|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab|Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss])|Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable AUC(0-∞) for Cycle 1 and AUC(τ,ss) for Cycle 2 PK data.||Microgram*day/milliliter (µg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
25090|NCT01682135|Primary|Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab||Cycle 2-5: Predose|All enrolled participants who received at least one dose of study drug and had evaluable Cmin PK data.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
25091|NCT01682135|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable Cmax pharmacokinetics (PK) data.||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
25092|NCT01682135|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)|A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.|Baseline through Study Completion (Up to 12 Weeks)|All enrolled participants who received at least one dose of study drug.||Participants|||Number
25093|NCT01682031|Secondary|Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)|Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.|Up to 3 months post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
25094|NCT01682031|Secondary|CRT Dose Delivery|This characteristic will be included in Cox models.|Up to 8 weeks|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
25095|NCT01682031|Secondary|Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years post-treatment|All treated and eligible patients||number of xerostomia events|||Number
25096|NCT01682031|Secondary|Quality of Life||Up to 1 year post-treatment|Due to the study's early termination and inadequate number of patients, no patients were analyzed.|||||
25097|NCT01682031|Secondary|Overall Survival|Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
25098|NCT01682031|Secondary|Relapse-free Survival (RFS)|Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.|At 1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
25099|NCT01682031|Secondary|Tumor Complete Response Rate|Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
25100|NCT01682031|Primary|Incidence of >= Grade 3 Mucositis|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
25101|NCT01681576|Secondary|Mean Sitting Pulse Pressure (PP) Over Time|Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmHg||Standard Deviation|Mean
25102|NCT01681576|Secondary|Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time|Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mmHg||Standard Deviation|Mean
25103|NCT01681576|Secondary|Urine Volume (Diuresis) Over Time|Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28|Day -1, Day 1 & Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.||mL||Standard Deviation|Mean
25174|NCT01680861|Secondary|Graft Loss (Return to Permanent Dialysis or Death)||during the first 12 months post-transplant|||participants|||Number
25107|NCT01681511|Primary|The Proportion of Subjects With at Least One CAUTI|"CAUTI is as determined by blinded investigator assessment per protocol definition.~DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met.~Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD.~p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model.~Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.~CZD = Catheterized or catheter"|48 ± 24 hours or more|||participants|||Number
25108|NCT01681511|Secondary|The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)|Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.|up to 30th day from the time of catheterization|||participants|||Number
25109|NCT01681511|Secondary|The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)|Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells [WBC]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine|up to 30th day from the time of catheterization|||Participants|||Number
25110|NCT01681511|Primary|Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.|"All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed.~Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP."|up to 30th day from the time of catheterization|||participants|||Number
25111|NCT01681472|Primary|Comparison of Folate Concentration in Tumor Tissue and Adjacent Mucosa Between Treatment Arms.||Sample taken Day 1 (Day of surgery).|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.||pmol/g||Standard Deviation|Mean
25112|NCT01681368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months|||participants|||Number
25113|NCT01681368|Primary|Objective Response (Complete Response (CR) or Partial Response (PR) Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria) or Disease Stabilization for Greater Than 6 Months|Per the RECIST criteria, CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months|||participants|||Number
25114|NCT01681277|Secondary|RA,AUC|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS||Ratio||Geometric Coefficient of Variation|Geometric Mean
25115|NCT01681277|Secondary|RA,Cmax|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS||Ratio||Geometric Coefficient of Variation|Geometric Mean
25116|NCT01681277|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.|PKS||h||Geometric Coefficient of Variation|Geometric Mean
25117|NCT01681277|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
25118|NCT01681277|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS||h||Full Range|Median
25119|NCT01681277|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PK analysis set (PKS): This set included all subjects of the TS who provided at least one observation for at least one secondary PK endpoint without important protocol violations.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
25120|NCT01681277|Primary|Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings|Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)|From administration of study drug until end-of-study, up to 17 days|Treated Set (TS)||participants|||Number
25121|NCT01681277|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study, up to 17 days|Treated set||percentage of participants|||Number
25122|NCT01681212|Secondary|Number of Patients Who Died and Who Had Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, Grade 3-4 AEs, and Related Grade 3-4 AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death.|First dose to 90 days following last dose of study drug. All deaths were poststudy, occurring more than 90 days after the last dose of study drug.|All participants who received at least 1 dose of study drug||Participants|||Number
25123|NCT01681212|Secondary|Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs are adverse events of unknown cause, consistent with an immune phenomenon, and considered to be causally related to drug exposure. Six subcategories of irAE are assessed: gastrointestinal, liver, skin, endocrine, neurologic, and other. The irAEs are programmatically determined from a predefined list of MedDRA terms. irAEs will be measured every 3 weeks in induction phase, every 6 weeks in Maintenance Phase to Week 48, and every 12 weeks until Progressive Disease. Grading criteria: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|First dose to 90 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
25124|NCT01681212|Primary|Percentage of Participants Surviving at 1 Year|Survival rate=percentage of participants surviving at 1 year following start of study drug. Every effort was made to collect survival data on all patients, including those withdrawn from treatment for any reason. If the death of a patient was not reported, the patient's last known alive date was recorded. Confidence intervals were computed using the Clopper-Pearson method.|At 1 year from start of study drug|All participants who received at least 1 dose of study drug.||Percentage of participants||90% Confidence Interval|Number
25125|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
25126|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
25127|NCT01681121|Secondary|Evaluate the Safety and Tolerability of ADX-N05 vs Placebo in Adults With Narcolepsy by Assessing Treatment Emergent Adverse Events, Vital Signs, Laboratory Results, ECGs, and Physical Exams.||12 weeks||||||
25128|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
25129|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
25130|NCT01681121|Secondary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
25131|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
25132|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
25133|NCT01681121|Secondary|Evaluate the Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo||4 weeks||||||
25134|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
25135|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Week 4||4 weeks||||||
25136|NCT01681121|Primary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks||||||
25137|NCT01681121|Primary|Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test for ADX-N05 vs. Placebo at Last Assessment.|Sleep Latency - The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.|Baseline and 12 weeks|93 subject were randomly assigned to a treatment group; 90 subjects (43 on ADX-N05 and 47 on Placebo) had at least one post-Basdeline efficacy assessment (Intent-to-treat [ITT] Population). For the primary endpoint analysis (40 on ADX-N05 and 45 on Placebo) have assessment week 12/last assessment||Minutes||Standard Deviation|Mean
25138|NCT01681069|Secondary|Change in Mean Body Fat at End of Study From Baseline|Measured in kg using calibrated weighing scales|12 weeks|||kg||Standard Deviation|Mean
25139|NCT01681069|Secondary|Change in Waist Circumference (in cm) at End of Study From Baseline|Difference in waist circumference (in cm) at end of study from baseline|12 weeks|||cm||Standard Deviation|Mean
25140|NCT01681069|Primary|Change in Body Weight at End of Study Compared to Baseline|Change in body weight at the end of study compared to baseline|12 weeks|||kg||Standard Deviation|Mean
25175|NCT01680861|Secondary|Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant|Incidence of (biopsy-proven) chronic allograft nephropathy (CAI) [interstitial fibrosis and tubular atrophy, using standard Banff criteria] at 12 months post-transplant.|1 year|||participants|||Number
25141|NCT01680991|Secondary|Time to Recovery of CD19+ B-cell|Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|"Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n represents the number of participants evaluable for the specified category."||days||Standard Deviation|Mean
25142|NCT01680991|Secondary|Duration of Depletion of CD19+ B-cell|Depletion is defined as CD19+ B-cell count < 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||days||Standard Deviation|Mean
25143|NCT01680991|Secondary|Number of Participants With B-cell Depletion or Recovery|Depletion is defined as cluster of differentiation (CD) 19+ B-cell count <0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population.||participants|||Number
25144|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)|Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.|Cycle 1, Day 1|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
25145|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Human Antibodies (HAHA)|For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.|Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up|"Safety analysis population. n represents the number of participants who were evaluable at the specified time point."||participants|||Number
25146|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.||percentage of participants||95% Confidence Interval|Number
25147|NCT01680991|Secondary|Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL <4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu >1.5 x 10^9/L without the need for EGF, ii. Plt >100 x 10^9/L without the need for EGF, and iii. Hb >11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.||percentage of participants||95% Confidence Interval|Number
25148|NCT01680991|Secondary|Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants||percentage of participants||95% Confidence Interval|Number
25149|NCT01680991|Secondary|Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (<) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] >1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) >100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) >11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.||percentage of participants||95% Confidence Interval|Number
25150|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
25151|NCT01680991|Secondary|Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN >1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
25152|NCT01680991|Secondary|Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
25153|NCT01680991|Secondary|Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (>) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.||percentage of participants||95% Confidence Interval|Number
25154|NCT01680991|Secondary|Minimum Observed Serum Concentration of Obinutuzumab||Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1|"PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and n is the number of participants evaluable at the specified time point."||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
25155|NCT01680991|Secondary|Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mL/day||Geometric Coefficient of Variation|Geometric Mean
25156|NCT01680991|Secondary|Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8|Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liter||Geometric Coefficient of Variation|Geometric Mean
25157|NCT01680991|Secondary|Apparent Terminal Half-life (t1/2)|Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||day||Geometric Coefficient of Variation|Geometric Mean
25158|NCT01680991|Secondary|Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
25159|NCT01680991|Primary|Cmax of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
25160|NCT01680991|Primary|Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
25161|NCT01680991|Primary|Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
25162|NCT01680991|Primary|Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.||day*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
25163|NCT01680900|Primary|Daily Diary Ratings of Severity of Hot Flashes|Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe).|Week 8.|all participants randomized to treatment||units on a scale||95% Confidence Interval|Mean
25164|NCT01680900|Other Pre-specified|Sheehan Global Ratings of Symptom (Hot Flash)Interference|Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.|Change from Baseline at Week 8||||||
25165|NCT01680900|Other Pre-specified|Percentage of Participants That Were Satisfied or Very Satisfied|Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).|Week 8|all participants with at least one treatment response.||percentage of participants|||Number
25166|NCT01680900|Other Pre-specified|Number of Participants With Adverse Events|A 17 item checklist of general adverse and withdrawal symptoms. It will be used at baseline and Week 12. Adverse events will be obtained by subject report at Week 4 and Week 8.|Baseline and Week 12|||participants|||Number
25167|NCT01680900|Secondary|Menopause-related Quality of Life (MENQOL)|The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory. Each of 29 items is rated on a scale of 0 to 6 (extremely bothersome). The items are divided into 4 subscales. The item scores are summed in each subscale and means are computed for the 4 subscales. The total score is the sum of the mean subscale scores. Higher scores are more symptomatic.|Week 8|||units on a scale||95% Confidence Interval|Mean
25168|NCT01680900|Secondary|Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes|Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries|Percent change from baseline at Week 8|all participants with at least one treatment response||percentage of participants|||Number
25169|NCT01680900|Primary|Daily Diary Ratings of Frequency of Hot Flashes|Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported.|Week 8.|all participants randomized to treatment||number of hot flashes||95% Confidence Interval|Mean
25170|NCT01680861|Secondary|Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)||during the first 12 months post-transplant|Note: one patient in the Tacrolimus/EC-MPS arm discontinued EC-MPS at 12 months post-transplant following a colon cancer diagnosis and the necessity to receive chemotherapy.||participants|||Number
25171|NCT01680861|Secondary|eGFR (Renal Function) at 6 Months Post-transplant|using the abbreviated MDRD formula.|at 6 months post-transplant|||ml/min per 1.73 m2||Standard Error|Mean
25172|NCT01680861|Secondary|eGFR (Renal Function) at Month 3 Post-transplant|Renal function as determined by the estimated glomerular filtration rate (eGFR) at 3 months post-transplant, using the abbreviated MDRD formula.|at 3 months post-transplant|||ml/min per 1.73 m^2||Standard Error|Mean
25173|NCT01680861|Secondary|eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.|using the abbreviated MDRD formula.|at 1 month post-transplant|||ml/min per 1.73 m2||Standard Error|Mean
25182|NCT01680497|Secondary|Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale|Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).|Day 0, Day 14, Month 12, Month 12.5|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
25183|NCT01680497|Secondary|Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale|Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
25184|NCT01680497|Secondary|Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
25185|NCT01680497|Secondary|Investigator Assessment of Ease of Injection Use on a 10-Point Scale|Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).|Day 0, Day 14|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
25186|NCT01680497|Secondary|Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale|Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
25187|NCT01680497|Secondary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
25188|NCT01680497|Primary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point||Scores on a Scale||Standard Deviation|Mean
25189|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.||Participants|||Number
25190|NCT01680458|Primary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.||Participants|||Number
25191|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.||Participants|||Number
25192|NCT01680458|Secondary|Onset Rate of Deep Mycosis|Efficacy of deep mycosis prophylaxis was evaluated by the presence or absence of deep mycosis onset during the observation period. Onset rate of deep mycosis was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Onset rate of deep mycosis (%) = (Number of participants with deep mycosis onset by target fungi) / (Number of participants available for prophylactic efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for prophylaxis comprised of participants in SAS who had started to receive fluconazole for the prophylaxis and had been evaluated for the presence or absence of deep mycosis onset.||Percentage of participants||95% Confidence Interval|Number
25206|NCT01680328|Secondary|Acceptance of Injection Pain After Injection at Different Speeds.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.||scores|||Number
25207|NCT01680328|Secondary|Acceptance of Injection Pain After Injection of Different Volumes.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.||scores|||Number
27687|NCT01643525|Primary|Sensitivity, Specificity and Predictive Values of the Jan Medical DC1 System in Detecting Ischemia Within 12 Hours of Known Stroke Onset in Comparison to Follow up CT and MRI.||At study completion- approximately 8 months|Terminated study, data incomplete. Data not analyzed.|||||
25193|NCT01680458|Secondary|Fungi Eradication Rate|Mycological effect of treatment was evaluated as follows: (1) eradicated; the causative fungi detected from the lesion before treatment became undetectable, (2) presumably eradicated; the lesion was improved and sampling of causative fungi became impossible, (3) decreased; the causative fungi were decreased, (4) unchanged; no change was observed in the causative fungi, (5) increased; the causative fungi were increased (including microbial substitution), and (6) indeterminate; the clinical follow-up was inadequate, causative fungi were undetectable, or mycological test was not performed. Fungi eradication rate was calculated as follows. Fungi eradication rate (%) = (Number of participants evaluated as “eradicated” or “presumably eradicated”) / (Number of participants available for mycological efficacy evaluation) x 100|MAX 13 Weeks|Mycological analysis set for treatment comprised of participants in SAS with the final diagnosis of deep mycosis, who had started to receive fluconazole for the treatment and had been evaluated for the mycological effect.||Percentage of participants|||Number
25194|NCT01680458|Secondary|Clinical Efficacy Rate|Clinical effect of treatment was evaluated based on the clinical course excluding mycological effect as follows: (1) effective, (2) ineffective, or (3) unevaluable. Clinical efficacy rate was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Clinical efficacy rate (%) = (Number of responders in evaluation of clinical effect) / (Number of participants available for clinical efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for treatment comprised of participants in safety analysis set (SAS) who had started to receive fluconazole for the treatment and had been evaluated for the clinical effect.||Percentage of participants||95% Confidence Interval|Number
25195|NCT01680341|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.||episodes|||Number
25196|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|From week 16 to end of trial including follow-up (week 27)|The safety analysis set included all subjects who received at least one dose of the investigational product. Subjects in maintenance period were included in this analysis.||episodes|||Number
25197|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.||episodes|||Number
25198|NCT01680341|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0-28|The safety analysis set included all subjects who received at least one dose of the investigational product.||number of events|||Number
25199|NCT01680341|Secondary|Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia|Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Twenty five (25) subjects did not contribute to statistical analysis as Endpoint was only defined for subjects exposed for at least 12 treatment weeks.||percentage of subjects|||Number
25200|NCT01680341|Secondary|Subjects With HbA1c Below 7.0%|Number of subjects with HbA1c below 7% after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.||Subjects|||Number
25201|NCT01680341|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
25202|NCT01680341|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
25203|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.||mcL||Standard Deviation|Mean
25204|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.||mcL||Standard Deviation|Mean
25208|NCT01680328|Primary|Injection Pain (VAS mm)|Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. A total of 4 subjects did not contribute to the analysis due to missing injections (2) and missing VAS evaluation (2).||mm||Standard Deviation|Mean
25209|NCT01680172|Primary|Hospital Anxiety Depression Scale- Depression Score (HADS-D)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.||units on a scale||Standard Deviation|Mean
25210|NCT01680172|Primary|Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.||units on a scale||Standard Deviation|Mean
25211|NCT01680016|Primary|Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|from V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
25212|NCT01680016|Primary|Number of Children Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|From V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
25213|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.||Concentration (IU/ml)||95% Confidence Interval|Geometric Mean
25214|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After First Vaccination in Children.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.||Concentration (IU/mL)||95% Confidence Interval|Geometric Mean
25215|NCT01680016|Primary|Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set||Subjects|||Number
25216|NCT01680016|Primary|Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
25217|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
25218|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
25219|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
25220|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
25221|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years|Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|Analysis was done on the PP set.||IU/mL||95% Confidence Interval|Geometric Mean
25222|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||IU/mL||95% Confidence Interval|Geometric Mean
25223|NCT01679613|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from time 0 to the last quantifiable nintedanib plasma concentration.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
25224|NCT01679613|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
25225|NCT01679613|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|The treated set (TS) includes all subjects who were dispensed study medication and were documented to have taken at least one dose of study medication (nintedanib or ketoconazole).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
25226|NCT01679600|Primary|Peak Oxygen Uptake (V'O2peak)||4 weeks|||mL/min||Standard Deviation|Mean
25227|NCT01679314|Secondary|Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)|Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state|Baseline vs 8 weeks|One patient in the Active AlphaCore group missing data at 8 weeks.||units on a scale||Standard Deviation|Mean
25228|NCT01679314|Secondary|Number of Subjects With Adverse Events (AE)|"All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.~Brief description of the event (diagnosis)~Start date (and time, if relevant)~Stop date (and time, if relevant) (or resolution)~Severity~Action taken regarding the medical device~Opinion on causality~Seriousness~Outcome"|Throughout the course of the study (baseline to the 4 month follow-up visit)|All subjects reporting any Adverse Event||participants|||Number
25229|NCT01679314|Secondary|Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.~Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index"|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at 8 weeks.||participants|||Number
25230|NCT01679314|Secondary|Change in Forced Expiratory Volume (FEV1)|"Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation.~Change from baseline to week 8 between treatment groups"|Baseline vs 8 weeks|One subject in the Active AlphaCore group missing data at week 8||Percentage of predicted value||Standard Deviation|Mean
25231|NCT01679314|Secondary|Change 6 Minutes Walking Test|Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at week 8||Meter||Standard Deviation|Mean
25232|NCT01679314|Secondary|Change in Borg Dyspnoea Scores|Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8|Baseline vs 8 weeks|One subject in the Active AlphaCore device Group missing data at 8 weeks.||Scores on a scale||Standard Deviation|Mean
25252|NCT01678846|Secondary|Child Mental Health|score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).|2-year follow-up|||units on a scale||Standard Deviation|Mean
25253|NCT01678846|Primary|Physical Violence From School Staff|past week experience of any physical violence from school staff|2-year follow-up|||participants|||Number
25233|NCT01679314|Primary|Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups|Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline.|8 weeks|One patient in the Active AlphaCore device Group missing data at 8 weeks.||units on a scale||95% Confidence Interval|Least Squares Mean
25234|NCT01679236|Secondary|Alcohol Use in Study Subjects vs Controls|Timeline follow back participant self-report of daily alcohol use.|2 weeks post quit day||||||
25235|NCT01679236|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day|2 weeks post quit day|total enrolled||participants|||Number
25236|NCT01679028|Primary|Incidence of Adverse Drug Events and Serious Adverse Events|the Incidence of Adverse Drug Events and serious adverse events|30 days (after first dosing)|||adverse event|||Number
25237|NCT01679002|Secondary|Number of of Subjects Reporting at Least One Adverse Event|Number of of subjects reporting at least one adverse event.|8 weeks|The results are related to overall population in the study devided by period of treatment.||Number of of subjects reporting at least|||Number
25238|NCT01679002|Secondary|AUC - Area Under the Plasma Concentration Versus Time Curve|"AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:~BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.||ng*h/mL||Standard Deviation|Mean
25239|NCT01679002|Primary|Cmax - Maximum Observed Plasma Drug Concentration|"Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:~BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.||ng/mL||Standard Deviation|Mean
25240|NCT01678976|Other Pre-specified|Total of Subjects Reporting at Least One Adverse Event|Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient|4 weeks|||subjects reporting at least 1 AE|||Number
25241|NCT01678976|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.||ng*h/mL||Standard Deviation|Mean
25242|NCT01678976|Primary|Maximum Drug Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.||ng/mL||Standard Deviation|Mean
25243|NCT01678911|Secondary|Patient Global Impression of Change|Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.|4 Visits over 15 weeks|||participants|||Number
25244|NCT01678911|Secondary|Center for Epidemiologic Studies Depression Scale|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|4 visits over 15 week period|||units on a scale||Standard Deviation|Mean
25245|NCT01678911|Secondary|Pain Disability Index|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|4 visits over an 8 week period|||units on a scale||Standard Deviation|Mean
25246|NCT01678911|Secondary|Pain Anxiety Symptoms Scale|The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|4 Visits over an 8 week period|||units on the PASS scale||Standard Deviation|Mean
25247|NCT01678911|Primary|McGill Pain Questionnaire - Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).|4 Visits over a 15 week period|||units on a scale||Standard Deviation|Mean
25248|NCT01678885|Secondary|Weight Change|The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss|1 year|Free-living EI data were analyzed from the 42 participants who completed the protocol and provided urine samples for Doubly Labeled Water analysis.||kg||Standard Deviation|Mean
25249|NCT01678885|Primary|ENERGY BALANCE EQUATION|A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.|2 days|Free-living energy intake data were analyzed from the 42 participants who completed the protocol and provided urine samples for doubly labeled water analysis.||kCal||Standard Deviation|Mean
25250|NCT01678846|Secondary|Safety and Well-being at School|"Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:~I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school."|At 2 year follow-up|||units on a scale||Standard Deviation|Mean
25251|NCT01678846|Secondary|Educational Achievement: Word Recognition in English|Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).|2-year follow-up|||words per minute||Standard Deviation|Mean
25254|NCT01678820|Secondary|Percentage of Participants With A1C Level <7% at Week 16|Percentage of participants achieving glycemic goal (A1C <7%) after 16 weeks of treatment. Data as observed.|Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percentage of participants|||Number
25255|NCT01678820|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
25256|NCT01678820|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
25257|NCT01678820|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Mean
25258|NCT01678820|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
25259|NCT01678820|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
25260|NCT01678820|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
25261|NCT01678820|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent change||95% Confidence Interval|Least Squares Mean
25262|NCT01678820|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||mg/dL||95% Confidence Interval|Least Squares Mean
25263|NCT01678820|Secondary|Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent||95% Confidence Interval|Least Squares Mean
25264|NCT01678820|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||Participants|||Number
25265|NCT01678820|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||Participants|||Number
25266|NCT01678820|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.|Baseline and Week 16|Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).||Percent||95% Confidence Interval|Least Squares Mean
25384|NCT01675453|Secondary|Blood Loss|Bleeding from chest tubes|24 hours||||||
25385|NCT01675453|Secondary|Rate of Neurological Complications|Delirium, clinically diagnosed stroke, and encephalopathy.|24 hours||||||
25386|NCT01675453|Secondary|Stroke Volume Index||24 hours||||||
25267|NCT01678807|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment, up to 28 days|All randomized participants who receive at least one dose of study treatment||Percentage of participants|||Number
25268|NCT01678807|Primary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days|All randomized participants who receive at least one dose of study treatment||Percentage of participants|||Number
25269|NCT01678313|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires|"Efficacy:~Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||units on a scale||Standard Deviation|Mean
25270|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires|"Efficacy:~Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||units on a scale||Standard Deviation|Mean
25271|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires|"Efficacy:~Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||units on a scale||Standard Deviation|Mean
25272|NCT01678313|Secondary|Change From Baseline in the Maximum Flow Rate (Qmax)|"Efficacy:~Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||mL/s||Standard Deviation|Mean
25273|NCT01678313|Secondary|Change From Baseline in the Void Volume (VV)|"Efficacy:~Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||mL||Standard Deviation|Mean
25274|NCT01678313|Primary|Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level|"Efficacy:~Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment|||ng/mL||Standard Deviation|Mean
25275|NCT01678196|Secondary|Caregiver Burden|Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).|3 months post-randomization|Sample sizes are smaller than total sample size due to missing questionnaire data.||units on a scale||Standard Deviation|Mean
25276|NCT01678196|Secondary|Family Functioning|Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.|3 months after the initiation of the intervention|Sample sizes are smaller than the overall sample due to missing questionnaire data.||units on a scale||Standard Deviation|Mean
25277|NCT01678196|Secondary|Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18|Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).|3 months after initiation of the intervention|Group sample sizes are smaller than total sample sizes due to missing data.||units on a scale||Standard Deviation|Mean
25278|NCT01678196|Primary|Veteran Engagement in VA Mental Health Services|Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.|3 months after initiation of the intervention|||participants|||Number
25279|NCT01678131|Primary|Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA|Liver samples were collected by FNA at 3 of 5 of the following specified postdose timepoints: 3, 12, 24, 48 and 72 hours after a single vaniprevir dose on Day 7. The technical success of the FNA procedure was established for a participant if vaniprevir was detected from at least 2 of the 3 FNA collection timepoints.|Day 7 up to Day 10 at 3 of the following timepoints: 3, 12, 24, 48 and 72 hours postdose|Participants treated with vaniprevir who had hepatic FNA collected at 3 timepoints. One participant from the 300 mg Vaniprevir + Peg-IFN/RBV treatment group, and one participant from the 600 mg Vaniprevir + Peg-IFN/RBV treatment group discontinued treatment prior to collection of 3 FNAs, and were therefore excluded from the analysis.||Participants|||Number
25387|NCT01675453|Secondary|Rate of Hyperchloremic Metabolic Acidosis|blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.|24 hours||||||
25280|NCT01677988|Other Pre-specified|CTC Expression|To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient.|2 years|The CTC expression endpoint was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.|||||
25281|NCT01677988|Other Pre-specified|CTC Analysis|To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma.|End of study|The CTC analysis was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.|||||
25282|NCT01677988|Other Pre-specified|Feasibility Objective|The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population.|From enrollment to end of chemotherapy part of the study|The number of subjects who had 5-6 doses of neoadjuvant regimen||participants|||Number
25283|NCT01677988|Secondary|Overall Survival:|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|The study terminated early, prior to the end of the follow up period for all subjects. At the time of study termination, one subject had expired and the time from enrollment to death for that subject is reported below.||days|||Number
25284|NCT01677988|Secondary|Time to Recurrence:|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|The study terminated early, prior to the follow up period being completed. Only one subject had surgery and that subject is still alive at the time of study termination, so time to recurrence cannot be estimated.|||||
25285|NCT01677988|Secondary|Histopathologic Tumor Response|Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.|at the time of surgery|Only subjects who had surgery were included in this outcome measure.||grade II responder|||Number
25286|NCT01677988|Secondary|Radiographic Tumor Response|The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.|From enrollment to Surgery|All subjects enrolled and had a response assessment are included in the outcome measure below.||participants|||Number
25287|NCT01677988|Primary|Estimate the R0/R1 Resection Rate|Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.|at time of surgery|Only subjects who had surgery were included in the outcome measure data.||participants|||Number
25288|NCT01677936|Secondary|Systolic Blood Pressure|Raisins versus snacks: mmHg change in systolic blood pressure at week 12|12 weeks.|||mmHg||Standard Deviation|Mean
25289|NCT01677936|Primary|Postprandial Glucose Levels|Raisins versus snacks: percent change in postprandial glucose levels at week 12|12 weeks|||percent||Standard Deviation|Mean
25290|NCT01677767|Primary|Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.|Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.||Percentage of participants|||Number
25291|NCT01677767|Secondary|Number of Participants Received Concomitant Medications|Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.|Up to Week 24|The safety population included all participants enrolled into the study||Number of participants|||Number
25292|NCT01677767|Secondary|Evaluation of Dose Per Injection of C.E.R.A|The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.|Up to Week 24|The safety population included all participants enrolled into the study||Microgram||Standard Deviation|Mean
25293|NCT01677767|Secondary|Evaluation of Route of Administration for C.E.R.A|C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.|Up to Week 24|The safety population included all participants enrolled into the study||Number of injections|||Number
25294|NCT01677767|Secondary|Mean Time Spent by Participants in the Hb Target Range|Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.|Up to Week 24|ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.||Week||Standard Deviation|Mean
25295|NCT01677767|Secondary|Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study|For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.||Number of participants|||Number
25388|NCT01675453|Secondary|Rate of Acute Kidney Injury|serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.|48 hours||||||
25296|NCT01677767|Primary|Percentage of Participants Achieved Target Range of Hemoglobin|The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time – visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.||Percentage of participants|||Number
25297|NCT01677767|Primary|Mean Time Required to Achieve Target Hemoglobin Range|The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time – visit date of first dosing) + 1|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.||Week||Standard Deviation|Mean
25298|NCT01677767|Primary|Number of Participants With Co-morbidity Treated With C.E.R.A|Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.|Up to Week 24|The safety population included all participants enrolled into the study.||Number of participants|||Number
25299|NCT01677767|Primary|Mean Weight of Participants Treated With C.E.R.A|Weight of the participants was measured at the Baseline and summarized with descriptive statistics.|Baseline (Week 0)|The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.||Kilograms||Standard Deviation|Mean
25300|NCT01677767|Primary|Mean Age of Participants Treated With C.E.R.A|Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date – Date of birth)/365.25|Baseline (Week 0)|The safety population included all participants enrolled into the study.||Years||Standard Deviation|Mean
25301|NCT01677624|Secondary|Success Rate for Operability of Embolization|Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.||percentage of participants||95% Confidence Interval|Number
25302|NCT01677624|Primary|Success Rate of Embolization in the Target Vessel|Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.||Percentage of participants||95% Confidence Interval|Number
25303|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of PYY||Ratio of Day 5 to Baseline|Evaluable Population||none (values are ratios)||Standard Error|Least Squares Mean
25304|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of GLP-1||Ratio of Day 5 to Baseline|Evaluable||none (values are ratios)||Standard Error|Least Squares Mean
25305|NCT01677299|Primary|Change in Fasting Plasma Glucose|LS mean difference from Baseline (Day 1) to Day 5|Change from Baseline (Day 1) to Day 5|Evaluable Population||mg/dL||Standard Error|Least Squares Mean
25306|NCT01677299|Primary|Area Under the Curve (0-t) of Plasma Metformin|Measures from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration. The dose of study medication was administered at t = -1 min relative to the start time of the standardized breakfast.|Time points at which data were collected to create the area under the curve (0-t) for plasma metformin were: t = -0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 11 h relative to the start time of the standardized breakfast.|Evaluable Population||ng*h/mL||Standard Deviation|Mean
25307|NCT01677195|Primary|AFB1-lysine Adduct (pg/mg) Overtime|After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.|3 months on intervention (weeks 0-12); 1 month off intervention (week 16)|||pg/mg albumin||Standard Deviation|Mean
25308|NCT01677182|Secondary|Percentage of Participants With MADRS Remission|MADRS remission is defined as a MADRS total score less than or equal to (<=) 10. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. LOCF method was used to impute missing data.||percentage of participants|||Number
25309|NCT01677182|Secondary|Percentage of Participants With MADRS Response|MADRS response is defined as greater than or equal to (>=) 50 percent (%) decrease in the MADRS total score from baseline. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants|||Number
25389|NCT01675453|Secondary|Plasma Osmolarity||24 hours||||||
25390|NCT01675453|Secondary|Plasma Na||24 hours||||||
25310|NCT01677182|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 6|Q-LES-Q-SF is a self-administered, widely used 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are 2 global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of the total possible score, with higher scores indicating better health status.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||percentage of total possible score||Standard Error|Least Squares Mean
25311|NCT01677182|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS is a 3-item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over 3 inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11-point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30 where higher scores indicates greater severity of impairment.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
25312|NCT01677182|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
25313|NCT01677182|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) to Week 6|"The CGI-S assesses the clinician’s impression of the participant’s current state of mental illness and consists of 1 question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill)."|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
25314|NCT01677182|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score|The CGI-I assesses the clinician’s impression of the participant’s state of mental illness improvement and consists of 1 question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). In all cases, the assessment was independent of whether the rater believed the improvement was drug-related or not.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
25315|NCT01677182|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS is a 11-item scale to assess manic symptoms. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), and 7 items are rated on a scale from 0 to 4 with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on a scale||Standard Error|Least Squares Mean
25316|NCT01677182|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6|The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0(normal) to 6(most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.||units on scale||Standard Error|Least Squares Mean
25317|NCT01676896|Other Pre-specified|Lung Inflammation, Time 3|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.|Time 3 at 9 months|||uM||Standard Deviation|Mean
25318|NCT01676896|Other Pre-specified|Lung Inflammation, Time 2|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.|Time 2 at 5 months|||uM||Standard Deviation|Mean
25319|NCT01676896|Other Pre-specified|Lung Inflammation, Time 1|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.|Time 1 at baseline|||uM||Standard Deviation|Mean
25320|NCT01676896|Secondary|Medication Adherence, Time 3|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 3 visit.|Time 3 at 9 months|||number of yes responses||Standard Deviation|Mean
25391|NCT01675453|Secondary|Endothelial Integrity|Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.|24 hours||||||
25392|NCT01675453|Secondary|Inflammation Response|Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.|24 hours||||||
25321|NCT01676896|Secondary|Medication Adherence, Time 2|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 2 visit.|Time 2 at 5 months|||number of yes responses||Standard Deviation|Mean
25322|NCT01676896|Secondary|Medication Adherence, Time 1|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at study enrollment, Time 1.|Time 1 at baseline|||number of yes responses||Standard Deviation|Mean
25323|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 1|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at enrollment visit, Time 1 data visit.|Time 1 at baseline|||number of correct steps||Standard Deviation|Mean
25324|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 2|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 2 data visit.|Time 2 at 5 months|||number of correct steps||Standard Deviation|Mean
25325|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 3|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at time 3 data visit.|Time 3 at 9 months|||number of correct steps||Standard Deviation|Mean
25326|NCT01676896|Secondary|Home Asthma Management, Time 3|Parent report of asthma preventive and treatment activities. Data collected at third time point (Time 3). Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 3 at 9 months|||units on a scale||Standard Deviation|Mean
25327|NCT01676896|Secondary|Home Asthma Management, Time 2.|Parent report of asthma preventive and treatment activities. Data collected at the time 2 visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 2 at 5 months|||units on a scale||Standard Deviation|Mean
25328|NCT01676896|Secondary|Home Asthma Management, Time 1, Baseline|Parent report of asthma preventive and treatment activities. Data are collected at study enrollment, Time 1, baseline visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 1, baseline|||units on a scale||Standard Deviation|Mean
25329|NCT01676896|Secondary|Asthma Self-management, Time 1, Baseline|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the baseline, Time 1 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 1, baseline|||units on a scale||Standard Deviation|Mean
25330|NCT01676896|Secondary|Asthma Self-management, Time 2|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 2 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 2 at 5 months|||units on a scale||Standard Deviation|Mean
25331|NCT01676896|Secondary|Asthma Self-management, Time 3|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 3 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 3 at 9 months|||units on a scale||Standard Deviation|Mean
25332|NCT01676896|Primary|Quality of Life, Pre-study Year|Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months before baseline|||units on a scale||Standard Deviation|Mean
25333|NCT01676896|Primary|Emergency Department Visits, Pre-study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline|||number of visits||Standard Deviation|Mean
25334|NCT01676896|Primary|Number of Asthma Hospital Stays, During Study Year|Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.|12 months|||number of hospital stays||Standard Deviation|Mean
25335|NCT01676896|Primary|Number of Days in Hospital for Asthma, Pre-Study Year|Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline|||days hospitalized||Standard Deviation|Mean
25336|NCT01676896|Primary|Absenteeism Pre-study Year|(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.|12 months before baseline|Data for days enrolled and days absent for the pre-study year was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.||percentage of days enrolled||Standard Deviation|Mean
25337|NCT01676896|Primary|Number of Asthma Hospitalizations Pre-Study Year|Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline|||number of hospitalizations||Standard Deviation|Mean
25338|NCT01676896|Other Pre-specified|Lung Inflammation, Time 4|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.|Time 4 at 12 months|||uM||Standard Deviation|Mean
25339|NCT01676896|Secondary|Medication Adherence, Time 4|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at final data point, Time 4.|Time 4 at 12 months|||number of yes responses||Standard Deviation|Mean
25340|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 4|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 4 data visit.|Time 4 at 12 months|||number of correct steps||Standard Deviation|Mean
25341|NCT01676896|Secondary|Home Asthma Management, Time 4, End of Study|Parent report of asthma preventive and treatment activities. Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 4 at 12 months|||units on a scale||Standard Deviation|Mean
25342|NCT01676896|Secondary|Asthma Self-management, Time 4|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 4, final measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 4, at 12 months|||units on a scale||Standard Deviation|Mean
25343|NCT01676896|Primary|Emergency Department Visits, Study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.|12 months|||number of visits||Standard Deviation|Mean
25344|NCT01676896|Primary|Number of Days Hospitalized, During Study Year|Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.|12 months|||days hospitalized||Standard Deviation|Mean
25345|NCT01676896|Primary|Quality of Life, End of Study|Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months|||units on a scale||Standard Deviation|Mean
25346|NCT01676896|Primary|Absenteeism, End of Study|(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.|12 months|Data for days enrolled and days absent was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.||percentage of days enrolled||Standard Deviation|Mean
25347|NCT01676532|Other Pre-specified|Ontario Health Insurance Plan (OHIP)Status|OHIP status of students attending the clinic was not reported or collected|1 year||||||
25348|NCT01676532|Other Pre-specified|Absenteeism|Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected|1 year||||||
25349|NCT01676532|Other Pre-specified|Follow-up Appointments|Attendance at follow-up appoints was not collected.|1 year||||||
25350|NCT01676532|Other Pre-specified|Number of Students Referred to SBHC Who Attended SBHC|This data was not collected.|8 months||||||
25351|NCT01676532|Other Pre-specified|Number of Students Triaged From School Support Team Meetings|The number of students triaged from SST meetings was not collected.|1 year||||||
25352|NCT01676532|Other Pre-specified|Sprucecourt Public School Vs Other Participating Schools|To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools|8 months|total number of students who attended SBHC||participants|||Number
25353|NCT01676532|Other Pre-specified|Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)|The number of students who enrolled in SBHC who were from the host school Sprucecourt|8 months|Total number of students who enrolled in SBHC. Outcome is the number of students from host school (sprucecourt) who enrolled in SBHC||participants|||Number
25354|NCT01676532|Secondary|Number of Referrals Made of Students Attending SBHC|Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic|1 year|||participants|||Number
25355|NCT01676532|Secondary|Number of Students Attending SBHC With New Diagnoses|Number of students attending SBHC with new diagnoses|1 year|120 of the 127 students who attended the SBHC had a new diagnosis. 94 received one new diagnosis and 26 children received more than one new diagnosis||participants|||Number
25356|NCT01676532|Secondary|Number of Students Attending SBHC With New Treatment Plans|Proportion of children seen in the clinic with treatment plans|1 year|115 students out of 127 students attending SBHC had a new treatment plan.||participants|||Number
25357|NCT01676532|Primary|Number of Enrolled Participants Who Attended SBHC|"The primary objectives are to determine utilization of the SBHC including:~The number of students who are enrolled at the SBHC~The number of enrolled students enrolled who attended the SBHC"|1 year|379 students enrolled in the SBHC and 127 of those students attended SBHC. Existing data is based on 127 students who attended SBHC.||participants|||Number
25358|NCT01676298|Primary|Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.|"Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.~All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is Inconclusive for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement)."|After second pass result is complete (~3h)|||Percentage of Correct Calls|Participants|95% Confidence Interval|Number
27964|NCT01640184|Secondary|Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).|Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.|12 months|||participants|||Number
25359|NCT01676220|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to 12 months|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
25360|NCT01676220|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).||units on a scale||Standard Error|Least Squares Mean
25361|NCT01676220|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6|Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal insulin dose assessment.||U/kg||Standard Deviation|Mean
25362|NCT01676220|Secondary|Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint|Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).||percentage of mean||Standard Error|Least Squares Mean
25363|NCT01676220|Secondary|Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint|Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).||mmol/L||Standard Error|Least Squares Mean
25364|NCT01676220|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).||mmol/L||Standard Deviation|Mean
25365|NCT01676220|Secondary|Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).||percentage of participants|||Number
25366|NCT01676220|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).||mmol/L||Standard Error|Least Squares Mean
25367|NCT01676220|Secondary|Percentage of Participants With HbA1c <7% at Month 6|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).||percentage of participants|||Number
25368|NCT01676220|Secondary|Variability of Preinjection SMPG at Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Month 6|mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).||percentage of mean||Standard Error|Least Squares Mean
25369|NCT01676220|Secondary|Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)||mmol/L||Standard Error|Least Squares Mean
25370|NCT01676220|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.|Week 9 Up to Month 6|Modified intent-to-treat population.||percentage of participants|||Number
25371|NCT01676220|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).||percentage of hemoglobin||Standard Error|Least Squares Mean
25372|NCT01676012|Secondary|Sensitivity and Specificity of HD Videobronchoscopy|When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.|one year||||||
25373|NCT01676012|Primary|Sensitivity|Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.|one year|Vascular abnormalities were scored most frequently in HD + i-scan2 bronchoscopy. Sites suspicious for preinvasive lesions were most frequently reported using AFB. Tumors were detected equally by all modalities. The preferred modality was HD bronchoscopy with i-scan.||# vascular sites detected per patient||Standard Error|Mean
25374|NCT01675830|Secondary|Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use|To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.|These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.|Number of adverse events observed||adverse events|||Number
25375|NCT01675830|Primary|Head Wrap Feasibility|To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.|<12 hours|Percentage of respondents that agree device is easy to use||percentage of respondents|||Number
25376|NCT01675544|Primary|Mortality|All cause mortality at 1 year|1 year|||participants|||Number
25377|NCT01675544|Primary|Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)||1 year|||participants|||Number
25378|NCT01675531|Secondary|Patient's Overall Satisfaction|Patient's overall satisfaction was assessed 7 scales from very much worse to very much improved. (Very much worse, much worse, minimally worse, no change, minimally improved, much improved, very much improved)|4weeks|Analysis of ITT population set.||participants|||Number
25379|NCT01675531|Secondary|Physician's Overall Satisfaction|Physician's overall satisfaction was scored 7 scales from Very much worse to Very much improved. (Very much worse, much worse, minimally worse, No change, Minimally improved, much improved, very much improved).|4 weeks|Analysis of ITT population set.||participants|||Number
25380|NCT01675531|Secondary|Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).|"Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FAICT-GOG/NTX).~The mean changes in FACT/GOG-NTX total score and each FACT/GOG-NTX subscale score from Visit 1 (Week 0) to Visit 4 (Week 4 post-treatment) were analyzed. Missing data was handled as LOCF(Last Observation Carried Forward Method).~FACT/GOG-NTX total score range was from 0 to 152. The average change score from baseline to visit 4 indicates thay a lower score on the FACT/GOG-NTX means lower quality of life and a greater impact of neurotoxic symptom on the patient’s life."|4 weeks|Analysis of ITT population set.||units on a scale||Standard Deviation|Mean
25381|NCT01675531|Primary|NRS (Numeric Rating Scale)|"Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0).~NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline."|4 weeks|Analysis of ITT population set. Missing data was handled as LOCF(Last Observation Carried Forward Method).||units on a scale||Standard Deviation|Mean
25382|NCT01675453|Secondary|Chloride Loading|The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay|24 h||||||
25383|NCT01675453|Secondary|Duration of Mechanical Ventilation||24 hours||||||
25397|NCT01675453|Primary|Extravascular Lung Water Index|Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to “Predicted Body Weight”.|baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1|||mL/kg||Inter-Quartile Range|Median
25398|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25399|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25400|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 g/dL or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25401|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 grams per deciliter (g/dL) or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25402|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included SVR, relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25403|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included sustained virological response (SVR), relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25404|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25405|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25478|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25406|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included RVR, cEVR, and pEVR. RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25407|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included rapid virological response (RVR), complete early virological response (cEVR), and partial early virological response (pEVR). RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the lower limit of detection (LLOD) for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25408|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25409|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25410|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25411|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25412|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25413|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25414|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
31083|NCT01587079|Secondary|Peak Change From Baseline in Inspiratory Capacity on Day 1|Peak change from baseline in Inspiratory Capacity|Day 1|MITT||Milliliters||95% Confidence Interval|Least Squares Mean
25415|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25416|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25417|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25418|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25419|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25420|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25421|NCT01675427|Secondary|Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25422|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25423|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25424|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25425|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25426|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25427|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25440|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25428|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25429|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25430|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25431|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).||participants|||Number
25432|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25433|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25434|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25435|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25436|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
25437|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
25438|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
25439|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells per liter (10^9 cells/L).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||10^9 cells/L||95% Confidence Interval|Mean
30294|NCT01600287|Secondary|Intraoperative Phenylephrine Used (Pre CPB)|total phenylephrine dose needed to be used in the pre CPB period to maintain hemodynamic stability|2 hours(approx)|||microgram per Kg body weight||Standard Deviation|Mean
25441|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25442|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25443|NCT01675427|Secondary|Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25444|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25445|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25446|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25447|NCT01675427|Secondary|Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 international units per liter [IU/L] for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||ratio||95% Confidence Interval|Mean
25448|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
25449|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
25450|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
25451|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
25674|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
25452|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
25453|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kilopascals (kPa).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||kPa||95% Confidence Interval|Mean
25454|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25455|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25456|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25457|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25458|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25459|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25460|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25461|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25462|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
27688|NCT01643213|Primary|Subject's Treatment Preference|Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline|30 minutes after activation of stimulation|||participants|||Number
25463|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 international units per milliliter (log10 IU/mL).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||log10 IU/mL||95% Confidence Interval|Mean
25464|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25465|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25466|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25467|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25468|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg/m^2||95% Confidence Interval|Mean
25469|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg/m^2||95% Confidence Interval|Mean
25470|NCT01675427|Secondary|BMI by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg/m^2||95% Confidence Interval|Mean
25471|NCT01675427|Secondary|Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kilograms per meter-squared (kg/m^2), and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg/m^2||95% Confidence Interval|Mean
25472|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg||95% Confidence Interval|Mean
25473|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg||95% Confidence Interval|Mean
25474|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||kg||95% Confidence Interval|Mean
25475|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kilograms (kg).|Study Visit 1|Core Analysis Population (Treatment-Naive).||kg||95% Confidence Interval|Mean
25476|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25477|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25479|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25480|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25481|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25482|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).||participants|||Number
25483|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).||participants|||Number
25484|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25485|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25486|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25487|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25488|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25489|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25490|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced): Only participants who had received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25491|NCT01675427|Primary|Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype (Genotype 1 [G1], Genotype 2 [G2], Genotype 3 [G3], Genotype 4 [G4], and all other genotypes [Other]) and cirrhosis status ('Cirrhosis/transition to cirrhosis' or 'No cirrhosis') were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1 (single study visit)|Core Analysis Population (Treatment-Naive): Only participants who had not received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.||participants|||Number
25492|NCT01675167|Secondary|Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep|Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.|Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).||participants|||Number
25493|NCT01675167|Secondary|Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).||units on a scale||Standard Deviation|Mean
25494|NCT01675167|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with RMDQ assessment at week 12 (n=225 buprenorphine and n=231 placebo).||units on a scale||Standard Deviation|Mean
25495|NCT01675167|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (19). Includes only participants with PGIC assessment at week 12 (n=231 buprenorphine and n=230 placebo).||units on a scale||Standard Deviation|Mean
25496|NCT01675167|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||percentage of participants|||Number
25497|NCT01675167|Secondary|Time to Optimal Dose of Open-label Study Medication|"Overall time to reach the optimum dose of study medication required to progress to double-blind treatment"|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment||days||Standard Deviation|Mean
25498|NCT01675167|Secondary|Number of Subjects With Opioid Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary|Week 1 to Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||participants|||Number
25499|NCT01675167|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||participants|||Number
25500|NCT01675167|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.||units on a scale||Standard Deviation|Mean
25501|NCT01675128|Secondary|Number of Participants With a Decrease in elF4E mRNA Expression in Peripheral Blood|Peripheral blood analysis of elF4E mRNA expression was performed using real time quantitative polymerase chain reaction (q-PCR) to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a decrease (criteria unavailable) in elF4E determines if the drug is working. Cell proliferation or reduction was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.||participants|||Number
25552|NCT01674634|Secondary|Clinical Success|Clinical success is defined as reduction of FFC of a treated joint to within 0-5 degrees of normal within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.||Joints|Participants||Number
25502|NCT01675128|Secondary|Number of Participants With a Reduced Effect of elF4E Inhibition on Relevant Regulated Proteins|Protein levels in the biopsy sample was assessed by immunohistochemistry using anti-oligonucleotide antibody to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a reduced effect (criteria unavailable) of elF4E inhibition on relevant regulated proteins determines if the drug is working.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.||participants|||Number
25503|NCT01675128|Secondary|Number of Participants With Intracellular and Stromal Presence of ISIS in Tumor Tissue|Intracellular and stromal presence of ISIS in tumor tissue was assessed by immunohistochemistry (IHC) and Crystal Violet staining to determine effectiveness of drug. Tissue that retains stain indicates intracellular and stromal presence of ISIS and determines if the drug is working. Relative staining intensity (intensity criteria unavailable) was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.||participants|||Number
25504|NCT01675128|Secondary|AUC(ALL) (Area Under the Plasma Concentration vs. Time Curve for All Time Points)|AUC(ALL) (Area under the plasma concentration vs. time curve for all time points) was assessed for CPT-11 (irinotecan), its active metabolite SN38, and the glucuronic acid metabolite of SN38, SN38-G to derive the total AUC(ALL).|up to 24 hours post end of infusion|Phase I Dose Level I and Phase I Dose Level II were grouped together for this outcome measure. Complete pharmacokinetic data for only ten of the fourteen participants enrolled on the phase I portion of the study were available for analysis. Data is unavailable to report each individual time point.||hr*ng/mL||Standard Deviation|Mean
25505|NCT01675128|Secondary|Overall Survival|Overall survival is defined as the time from the on study date until the date of death or date last known alive.|≥ 12 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, overall survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus overall survival data for Phase I Dose Level I.||participants|||Number
25506|NCT01675128|Secondary|Number of Participants With Progression Free Survival|Progression free survival is defined as the time beginning on the on study date and continuing until date of progression or date removed from study for an adverse event.|≤ 6 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, progression free survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there is no progression free survival data for Phase I Dose Level I.||participants|||Number
25507|NCT01675128|Secondary|Objective Response|Objective response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% reduction in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of athe diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progression).|up to 2 cycles|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable for response. Per protocol, no responses were to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there are no objective responses for Phase I Dose Level I.||participants|||Number
25508|NCT01675128|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|21 months|||participants|||Number
25509|NCT01675128|Primary|Number of Participants With a Change in elF4e Protein Levels in Matched Pre and Post Tumor Biopsies|A change in protein is defined as an increase or decrease compared to baseline and is measured between two time points by immunohistochemistry (IHC) analysis.|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.||participants|||Number
25510|NCT01675128|Primary|Number of Participants With a Change in the Level of a Particular Gene Called elF4E [Eukaryotic Initiation Factors (elF)4e Messenger Ribonucleic Acid (mRNA) Levels] in Matched Pre and Post Tumor Biopsies|A change in elF4e levels is defined as an increase or decrease compared to baseline and is measured between two time points before rand after 2 weeks of treatment by quantitative real-time reverse transcription polymerase chain reaction (qRT-PCR).|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.||participants|||Number
25511|NCT01675128|Primary|Maximum Tolerated Dose of Irinotecan in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years|||mg/m^2|||Number
25512|NCT01675128|Primary|Maximum Tolerated Dose (MTD) of ISIS 183750 in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years|||mg|||Number
25513|NCT01675011|Primary|Primary Endpoint|The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.|12 Months post study procedure|The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.|||||
25514|NCT01674725|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.||percentage of participants||95% Confidence Interval|Number
25515|NCT01674725|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population).||percentage of participants|||Number
25516|NCT01674725|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
25517|NCT01674725|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b]) and had hemoglobin ≥ LLN reference range at baseline.||percentage of participants|||Number
25518|NCT01674725|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.||percentage of participants|||Number
25519|NCT01674712|Secondary|Cystatin C|Collection and measurement of blood samples|12 weeks||||||
25520|NCT01674712|Secondary|Total Bilirubin|Collection and measurement of blood samples|12 weeks||||||
25521|NCT01674712|Secondary|Plasma Creatinine|Collection and measurement of blood samples|12 weeks||||||
25522|NCT01674712|Secondary|Alanine Aminotransferase (ALT)|Collection and measurement of blood samples|12 weeks||||||
25523|NCT01674712|Secondary|Creatine Kinase (CK)|Collection and measurement of blood samples|12 weeks||||||
25524|NCT01674712|Secondary|Adverse Events|Collection and measurement of blood samples|12 weeks||||||
25525|NCT01674712|Secondary|Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)|Collection and measurement of blood samples|12 weeks||||||
25526|NCT01674712|Secondary|Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline|Collection and measurement of blood samples|12 weeks||||||
25527|NCT01674712|Secondary|Percentage of Apolipoprotein B From Baseline|Collection and measurement of blood samples|12 weeks||||||
25528|NCT01674712|Secondary|Percentage of Apolipoprotein AI From Baseline|Collection and measurement of blood samples|12 weeks||||||
25529|NCT01674712|Secondary|Percentage of TC (Triglyceride) From Baseline|Collection and measurement of blood samples|12 weeks||||||
25530|NCT01674712|Secondary|Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline|Collection and measurement of blood samples|12 weeks||||||
25531|NCT01674712|Primary|Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.||percentage of change||Standard Deviation|Mean
25532|NCT01674712|Primary|Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.||percentage of change||Standard Deviation|Mean
25533|NCT01674712|Primary|Percentage of Change of TG (Triglyceride)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.||percentage of change||Standard Deviation|Mean
25542|NCT01674647|Secondary|Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms|Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25534|NCT01674647|Secondary|Number of Participants With Composite of Major and Non-major Bleeding Events|All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the SAF population. SAF population included all randomized subjects who received at least 1 dose of study medication.||Participants|||Number
25535|NCT01674647|Secondary|Number of Participants With All-cause Mortality|All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25536|NCT01674647|Secondary|Number of Participants With Cardiovascular Deaths|All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25537|NCT01674647|Secondary|Number of Participants With Myocardial Infarctions|All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25538|NCT01674647|Secondary|Number of Participants With Non-central Nervous System Systemic Embolisms|All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25539|NCT01674647|Secondary|Number of Participants With Transient Ischemic Attacks|All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25540|NCT01674647|Secondary|Number of Participants With Strokes|All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25541|NCT01674647|Secondary|Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality|Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.||Participants|||Number
25543|NCT01674647|Primary|Number of Participants With Major Bleedings as Per Central Adjudication|Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the safety analysis set (SAF) population. SAF population included all randomized subjects who received at least 1 dose of study medication.||Participants|||Number
25544|NCT01674647|Primary|Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death|Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the modified intention-to-treat (mITT) population. mITT population included all the randomized subjects in whom a left atrial/left atrial appendage (LA/LAA) thrombus was not diagnosed during a transesophageal echocardiogram (TEE) performed before the first planned cardioversion in the study.||Participants|||Number
25545|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61|The URAM scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||units on a scale|Participants|Standard Deviation|Mean
25546|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31|The Unité Rhumatologique des Affections de la Main (URAM) scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||units on a scale|Participants|Standard Deviation|Mean
25547|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 61|Investigator's determined the degree of improvement in the severity of the subject’s treated finger(s) compared with screening at the day 61 follow-up visit.|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Participants||Number
25548|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 31|Investigator's determined the degree of improvement in the severity of the subject’s treated finger(s) compared with screening at the day 31 follow-up visit.|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Participants||Number
25549|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 61|Subject's were asked to rate satisfaction with treatment at the day 61 follow-up visit|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Participants||Number
25550|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 31|Subject's were asked to rate satisfaction with treatment at the day 31 follow-up visit|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||Joint Pairs|Participants||Number
25551|NCT01674634|Secondary|Clinical Improvement|Clinical improvement is defined as a reduction of FFC by 50% or greater of the baseline value within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.||Joints|Participants||Number
25575|NCT01673984|Secondary|Patient Satisfaction With Treatment.|Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.|Month 12|No participant analysis as no data was collected due to low number of participants recruited in the study.|||||
25553|NCT01674634|Primary|Change From Baseline in Total Range of Motion|The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.||degrees|Participants|95% Confidence Interval|Mean
25554|NCT01674634|Primary|Percent Change From Baseline in Total Fixed Flexion|Percent change from baseline in total fixed flexion = 100 * (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.|Baseline, Day 31|Efficacy analysis was based on the modified intent-to-treat (mITT) population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on contralateral hand. Assessment is based on simultaneously treated joint pairs.||percentage of contracture change|Participants|Standard Deviation|Mean
25555|NCT01674621|Secondary|Safety and Tolerability|Physical examinations, vital signs, electrocardiograms, clinical laboratory tests, local tolerance, and adverse events.|6 Months||||||
25556|NCT01674621|Secondary|Serum Markers of Bone Formation and Resorption|Change in laboratory results; active compared to placebo.|6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.||Percent change||Standard Deviation|Mean
25557|NCT01674621|Secondary|BMD (Total Hip and Forearm)|Change in BMD, using DXA results; active compared to placebo.|6 Months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.||Percent change||Standard Deviation|Mean
25558|NCT01674621|Primary|BMD (Lumbar Spine)|Change in BMD, using DXA results; active compared to placebo.|6 Months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.||Percent change||Standard Deviation|Mean
25559|NCT01674062|Secondary|Cohorts 1 and 2: Overall Survival (OS)|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. OS was defined as the time from first dose to the time of death from any cause. Participants who did not experience death were censored at the last known alive date. OS was estimated using Kaplan-Meier and expressed in months.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).||months||80% Confidence Interval|Median
25560|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants Who Died|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants|||Number
25561|NCT01674062|Secondary|Cohorts 1 and 2: Progression-Free Survival (PFS) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. PFS was defined as the time from first dose to the time of disease progression or death. Participants without progression or death were censored at the last tumor assessment. PFS was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||weeks||80% Confidence Interval|Median
25562|NCT01674062|Secondary|Cohorts 1 and 2: Time to Progression (TTP) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. TTP was defined as the time from first dose to the time of first documented disease progression. Participants who withdrew from the study without documented progression were censored at the last tumor assessment. TTP was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||weeks||Full Range|Median
25563|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants With Disease Progression According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants|||Number
25576|NCT01673984|Secondary|Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)|TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.|6 and 12 month|Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.||units on a scale||95% Confidence Interval|Mean
25564|NCT01674062|Secondary|Cohorts 1 and 2: Time to Objective Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine the OR rate. Time to response was defined as the time from first dose to the time of initial response of CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Participants with disease progression were censored at the time of progression, and those with neither disease progression nor OR were censored at the last tumor assessment. Time to response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 21 months (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression; final analysis using February 2008 cutoff date)|All Treated Population (Cohorts 1 and 2 only).||weeks||Full Range|Median
25565|NCT01674062|Secondary|Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine OR and CBR rates. Duration of OR was defined as time from initial response of CR or PR to time of disease progression or death. Duration of CBR was defined similarly as time from initial response of CR or PR, or SD lasting at least 6 months, to time of disease progression or death. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Participants without progression or death following confirmed CR or PR were censored at the last tumor assessment. Duration of response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||weeks||Full Range|Median
25566|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or SD According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the CBR rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).||percentage of participants||80% Confidence Interval|Number
25567|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR or PR According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the OR rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).||percentage of participants||80% Confidence Interval|Number
25568|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or Stable Disease (SD) According to RECIST Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the clinical benefit response (CBR) rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants||80% Confidence Interval|Number
25569|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).||percentage of participants||80% Confidence Interval|Number
25570|NCT01674010|Secondary|Time to Recurrence of a Manic/Hypomanic or a Mixed Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure|||||
25571|NCT01674010|Secondary|Time to Recurrence of a Depressive Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure|||||
25572|NCT01674010|Secondary|Proportion of Study Participants With Recurrence of Any Mood Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure|||||
25573|NCT01674010|Primary|Treatment Emergent Adverse Events|The study was terminated early so no efficacy analysis was done, safety data are reported.|up to 48 weeks|TEAEs reported for Phase 2 were from the entire study period||participants|||Number
25574|NCT01673984|Secondary|Percentage of Participants Who Changed Injection Frequency After Completion of the Study||Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.||percentage of participants|||Number
25577|NCT01673984|Secondary|Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.|The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).|Baseline and Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.||units on a scale||95% Confidence Interval|Mean
25578|NCT01673984|Secondary|Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels|Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.|6 and 12 months|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.||percentage of participants|||Number
25579|NCT01673984|Secondary|Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..|12 months|Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.||percentage of participants|||Number
25580|NCT01673984|Primary|Percentage of Participants Maintaining Biochemical Castration|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.|6 months|Analysis based on intent-to-treat (ITT) population comprised of 21 patients.||percentage of participants|||Number
25581|NCT01673919|Secondary|Parent/Patient's Discomfort Index (Pain)|Participants or parents rated participant's pain by placing a horizontal line on a VAS of 0 (no pain) - 100 mm (unbearable pain). To describe the pain, a cut-off at 10 mm was used, and VAS <10 mm was defined as no pain.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
25582|NCT01673919|Secondary|Parent/Patient's Global Assessment of Disease Activity|Parent/patient global assessment of disease activity was performed using 0 to 100 mm VAS, and higher the score of VAS, worse the disease status (0= absence of activity or sign or symptom; 100= maximal activity or signs or symptoms). No disease activity was defined as VAS <=10 mm.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
25583|NCT01673919|Secondary|Physician’s Global Assessment of Disease Activity|The Physician's global assessment of disease activity was recorded on a 0 to 100 mm horizontal VAS where score 0 represented ‘arthritis inactive’ (i.e., symptom-free and no arthritis symptoms) and score 100 represented ‘arthritis very active’ (higher score indicate worsening of disease).|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||millimeter (mm)||Standard Deviation|Mean
25584|NCT01673919|Secondary|Number of Painful Joints|The painful joints were counted by physical examination and mean painful joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
25585|NCT01673919|Secondary|Number of Swollen Joints|The swollen joints was counted by physical examination and mean swollen joints were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
25586|NCT01673919|Secondary|Number of Joints With Active Range of Motion|The active range of motion joints was counted by physical examination and mean joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
25587|NCT01673919|Secondary|Number of Joints With Limitation of Motion|The most frequent symptom reported by most participants was a limitation of motion (LOM) of joints and it was determined by physical examination. The mean joints with limitation of motion were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||joints||Standard Deviation|Mean
25588|NCT01673919|Secondary|Number of Participants With a Minimally Important Improvement in the Childhood Health Assessment Questionnaire-Disability Index|The CHAQ-DI included questions on dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The disability index (DI) of the original CHAQ was graded on 4-point categorical scales of 30 items grouped into 8 domains of physical function. The highest scoring item in each domain determined the score for that domain. The score for the disability index was the mean of domain scores ranging from 0 to 3 (0 = without any difficulty and 3 = unable to do) with higher scores meaning higher disability. Minimally important improvement in CHAQ-DI was defined as a change from baseline of WA19977 core study (Day 1/Visit 1) >=0.13 at each visit.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
25589|NCT01673919|Secondary|Number of Participants Achieving Clinical Remission|Clinical remission was defined as inactive disease observed for at least 6 continuous months. Clinical remission was defined as per medication uptake as: Level 1 (clinical remission on medication), Level 2 (clinical remission off oral corticosteroid medication [still on TCZ]), Level 3 (clinical remission off both oral corticosteroid and methotrexate medication [still on TCZ]), and Level 4 (clinical remission off all anti-inflammatory medications [still on TCZ]). Number of participants at each clinical remission level was reported.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
25590|NCT01673919|Secondary|Number of Participants With Inactive Disease|Inactive disease was defined as: 1) No joints with active arthritis (no swollen, painful and lack of motion joints), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) No disease activity according to Physician's global assessment of disease activity (<= 10 millimeters [mm] on a VAS). The participant’s treating physician provided a rating of the participant’s arthritis disease activity on a 0 to 100 mm horizontal scale where score 0 represented ‘arthritis inactive’ (i.e., symptom-free and no arthritis symptoms) and score 100 represented ‘arthritis very active’.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
25591|NCT01673919|Secondary|Number of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology Response 50/70|The Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) is comprised of six components: Maximum number of joints with active arthritis; Number of joints with limitation of movement; Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP); Childhood Health Assessment Questionnaire-Disease Index (CHAQ-DI) graded on 4-point scales [0 = without any difficulty and 3 = unable to do] of 30 items grouped into 8 domains of physical function; Physician’s global assessment of disease activity and Participant’s global assessment of overall well-being (both assessed on a 0 to 100 mm Visual Analogue Scale [VAS], where score 0 = inactive arthritis and 100 = very active arthritis). A JIA ACR50/70 response is defined as improvement in at least three of the six core components by at least 50 percent (%), or 70%, respectively and no more than one of the remaining core components worsening by more than 30%.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all participants who had at least one efficacy assessment. Number (n) = number of participants analyzed for the given parameter at the specified visit.||participants|||Number
25592|NCT01673919|Secondary|Number of Participants With Abnormality in Physical Examinations|Participants with abnormal physical examinations of ear, nose and throat (asthma); extremities (synovitis, sequelae with flexion of the 5th right proximal interphalangeal joint, hallux valgus, deviations of metatarsophalangeal joints, and callus under metatarsal head); lung (mild bronchospasm); skin (vitiligo and hematoma, fatty subcutaneous infiltration on the neck, cutaneous eruption, and scalp pediculosis); and musculoskeletal system (discomfort in right hip) were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
25593|NCT01673919|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Parameters|Clinically significant abnormal parameters included eosinophil count, alanine aminotransferase, total bilirubin, and protein and blood in urine. Number of participants with these abnormal lab parameters was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
25594|NCT01673919|Secondary|Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths|Number of participants with AEs leading to TCZ modification, AEs leading to death, anaphylaxis or serious hypersensitivity, and deaths were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
25595|NCT01673919|Secondary|Mean Duration of Study Follow-Up|The participants were followed-up from Day 1 to last visit date (approximately 2 years). Mean time for which participants were followed up in the study was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||Months||Standard Deviation|Mean
25596|NCT01673919|Secondary|Mean Exposure to Study Treatment|Participants received TCZ for Week 104 or when TCZ was commercially available for pcJIA participants, whichever comes first in France. The mean TCZ exposure (time from first to last administration) was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||Months||Standard Deviation|Mean
25597|NCT01673919|Primary|Number of Participants With Adverse Events Related to Tocilizumab|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. Relatedness of any AEs was reported as possibly related, probably related, or remotely related to TCZ.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
25598|NCT01673919|Primary|Number of Participants With Adverse Events of Special Interest|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. The AEs of special interests included gingival bleeding, tooth abscess, acarodermatitis, ear infection, gastroenteritis, herpes zoster ophthalmic, lice infestation, nasopharyngitis, oral fungal infection, oral herpes, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheitis, tracheobronchitis, urinary tract infection, menorrhagia, asthma, epistaxis, and hematoma.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
25599|NCT01673919|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.||participants|||Number
25619|NCT01673698|Primary|Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24|An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.|Week 24|||percentage of EWL||Standard Error|Mean
25620|NCT01673620|Primary|Number of Participants Discontinuing Study Treatment Due to AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 2 weeks|The APaT population consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
25600|NCT01673867|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||percentage of participants||95% Confidence Interval|Number
25601|NCT01673867|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||participants|||Number
25602|NCT01673867|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||months||95% Confidence Interval|Median
25603|NCT01673867|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants||percentage of participants||95% Confidence Interval|Number
25604|NCT01673867|Primary|One-year Overall Survival (OS) Rate in All Randomized Participants|The one-year overall survival rate is a percentage, representing the fraction of all randomized participants who were alive following one year of treatment. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|12 months|All Randomized Participants||percentage of participants||95% Confidence Interval|Number
25605|NCT01673867|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CIs for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||months||95% Confidence Interval|Median
25606|NCT01673867|Secondary|Progression-Free Survival (PFS) Rate at 12 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 12 months after randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method.|Randomization to 12 months|All randomized participants||percentage of participants||95% Confidence Interval|Number
25607|NCT01673867|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response or complete response||months||Full Range|Median
25608|NCT01673867|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.~Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression or death, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response (PR) or complete response (CR).||months||Full Range|Median
25621|NCT01673620|Primary|Number of Participants Experiencing at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 4 weeks|The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
25609|NCT01673867|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All Randomized Participants||percentage of participants||95% Confidence Interval|Number
25610|NCT01673867|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants||months||95% Confidence Interval|Median
25611|NCT01673854|Other Pre-specified|Number of Participants With Adverse Events (AEs) Grade 3-4, Related AEs Grade 3-4, Related Serious Adverse Events (SAEs) Grade 3-4, Immune-related (ir) AEs Grade 3-4, and Serious irAEs Grade 3-4|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug||Participants|||Number
25612|NCT01673854|Other Pre-specified|Number of Participants Who Died, Who Died Due to Related Adverse Events (AEs), and With Related AEs, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to AEs and Related AEs, Immune-related (ir) AEs, and Serious irAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug||Participants|||Number
25613|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Hepatobiliary Adverse Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of vemurafenib and ipilimumab||Percentage of participants||95% Confidence Interval|Number
25614|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Gastrointestinal Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab.||Percentage of participants||95% Confidence Interval|Number
25615|NCT01673854|Primary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
25616|NCT01673802|Primary|Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT|CT scans were assessed for tumor visualization after use of Gadoxetate disodium|24 hrs|||participants|||Number
25617|NCT01673698|Secondary|Weight Loss Maintenance Six Months Following Device Removal|Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.|48 weeks|By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.||percentage of participant|||Number
25618|NCT01673698|Primary|Treatment Group Responder Rate Dichotomized at 25% EWL|An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of >25% EWL at 24 weeks was significantly greater than 35%.|24 weeks|By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.||percentage of participants|||Number
25622|NCT01673594|Primary|Safety|Number of adverse events throughout the course of the study|6 Weeks|||adverse events||Standard Deviation|Mean
25623|NCT01673594|Primary|Change in Score on AISRS From Baseline to Week 6|The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.|Baseline and 6 Weeks|||units on a scale||Standard Deviation|Mean
25624|NCT01673568|Secondary|Seroma Formation|Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.|postoperative day 7|||mL||Full Range|Median
25625|NCT01673568|Primary|Visual Analog Scale of Pain Activity|Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.|24 hours after hernia repair|||units on a scale||Full Range|Median
25626|NCT01673490|Secondary|Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points|The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Mililiter/seconds||Standard Deviation|Mean
25627|NCT01673490|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6|The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.|Baseline and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
25628|NCT01673490|Primary|Free to Total PSA Ratio at the Indicated Time Points|Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.|Baseline, Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Ratio||Standard Deviation|Mean
25629|NCT01673490|Primary|Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points|Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Microgram per liter (ug/L)||Standard Deviation|Mean
25630|NCT01673490|Primary|Number Participants With a Negative or Positive Response at the Indicated Time Points|Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
25631|NCT01673490|Primary|Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
25632|NCT01673490|Primary|Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
25633|NCT01673490|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.||Participants|||Number
25672|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
25634|NCT01673490|Primary|Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|ITT Population||Participants|||Number
25635|NCT01673490|Primary|Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.||Participants|||Number
25636|NCT01673425|Secondary|Serum Antibody Response to LAIV||Change from baseline in serum antibody response at 6 weeks||||||
25637|NCT01673425|Primary|IgA Antibody Titers||Change from baseline in antibody titer at 6 weeks|This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.|||||
25638|NCT01673282|Primary|The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)|Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.|From Baseline (Day 0) to 6 months|The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.||percent change of ratio in dose||Standard Deviation|Mean
25639|NCT01673256|Primary|Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.|"Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.~Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor."|4 days after Holter starts|||percentage||95% Confidence Interval|Number
25640|NCT01673178|Secondary|Apparent Clearance (CL) of PF-05231023|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liter/hour (L/hr)||Standard Deviation|Geometric Mean
25641|NCT01673178|Secondary|Plasma Decay Half-Life (t1/2) of PF-05231023|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Standard Deviation|Mean
25642|NCT01673178|Secondary|Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose|Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
25643|NCT01673178|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose|Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
25673|NCT01673178|Primary|Creatine Phosphokinase (CPK) Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||units per liter (U/L)||Full Range|Median
25644|NCT01673178|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ratio||Standard Deviation|Geometric Mean
25645|NCT01673178|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ratio||Standard Deviation|Geometric Mean
25646|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
25647|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Full Range|Median
25648|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
25649|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
25650|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.||hours||Full Range|Median
25651|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
25652|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
25653|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
25654|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 1|Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively||participants|||Number
25655|NCT01673178|Primary|Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24||Day 24|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively||mg/24 hours||Standard Deviation|Mean
25656|NCT01673178|Primary|Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.||milligram per 24 hours (mg/24hr)||Standard Deviation|Mean
25657|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25658|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25659|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25660|NCT01673178|Primary|Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||units per liter (U/L)||Standard Deviation|Mean
25661|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25662|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25663|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25664|NCT01673178|Primary|Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram per liter (mcg/l)||Standard Deviation|Mean
25665|NCT01673178|Primary|Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who receive at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25666|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25667|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Deviation|Mean
25668|NCT01673178|Primary|Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram per milliliter (NG/ML)||Standard Deviation|Mean
25669|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
25670|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
25671|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||U/L||Full Range|Median
25675|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
25676|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
25677|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Full Range|Median
25678|NCT01673178|Primary|Phosphate Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||milligram per deciliter (mg/dL)||Full Range|Median
25679|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
25680|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 39||Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
25681|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 25||Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
25682|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 1||Day 1|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcIU/mL||Standard Deviation|Mean
25683|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Baseline|Results are reported in micro international units per milliliter (mcIU/mL).|Baseline|Safety analysis set included all participants who received at least 1 dose of study medication.||mcIU/mL||Standard Deviation|Mean
25684|NCT01673178|Primary|Number of Participants With Abnormal Physical Examinations|Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.|Baseline up to Day 49|Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.|||||
25685|NCT01673178|Primary|Number of Participants With Clinically Significant Electrocardiogram Findings|Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia’s formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
25686|NCT01673178|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
25687|NCT01673178|Primary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
25688|NCT01673178|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
25689|NCT01673126|Secondary|Influence of Time Since Insult on the Results||participants will be followed for the duration of 1 year||||||
25690|NCT01673126|Secondary|Influence of Etiology on the Results||participants will be followed for the duration of 1 year||||||
25691|NCT01673126|Secondary|Influence of Diagnosis on the Results||participants will be followed for the duration of 1 year||||||
25692|NCT01673126|Primary|Change in CRS-R Total Scores|"At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations~The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.~Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).~The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors."|Baseline and directly after the tDCS (20 minutes)|||units on a scale||Standard Deviation|Mean
25693|NCT01673009|Secondary|Serum Bioactivity|The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)|7 days and 1 month|unable to measure this outcome because assay became unavailable|||||
25694|NCT01673009|Primary|Percent Change From Baseline in Tumor Volume at 6 Months|Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease|baseline to 6 months|||percentage change of tumor volume||95% Confidence Interval|Median
25695|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.||Hounsfield Units||Standard Deviation|Mean
25696|NCT01672996|Secondary|Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).|Recording the occurrence of treatment emergent adverse events (TEAE).|Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.|These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).||Adverse Events|||Number
25697|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.||Hounsfield Units||Standard Deviation|Mean
25698|NCT01672983|Secondary|Percentage of Participants With End of Treatment (EOT) Response|The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.|12 or 24 weeks after first dose of study drug|ITT population||percentage of participants||95% Confidence Interval|Number
25699|NCT01672983|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)|The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|12 weeks after last dose of study drug|ITT population||percentage of participants||95% Confidence Interval|Number
25700|NCT01672983|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.|TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.|Safety population: all participants who received at least 1 dose of study drug||participants|||Number
25701|NCT01672983|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|24 weeks after last dose of study drug|Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug||percentage of participants||95% Confidence Interval|Number
25702|NCT01672970|Secondary|Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25703|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25704|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25705|NCT01672970|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25706|NCT01672970|Secondary|Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6|"The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25707|NCT01672970|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25708|NCT01672970|Secondary|Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
25709|NCT01672970|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
25710|NCT01672970|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
25711|NCT01672970|Secondary|Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population||percentage of participants||95% Confidence Interval|Number
25722|NCT01672970|Secondary|Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ|A participant’s adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population||percentage of participants|||Number
25723|NCT01672970|Secondary|Number of Participants With Restoration of Initial Dosing Regimen of TCZ|The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.|6 months|Per protocol population||participants|||Number
25712|NCT01672970|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of >2.8 to <=10.0 represented low disease activity, a score of >10.0 to <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25713|NCT01672970|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician’s global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of >3.4 to <=11.0 represented low disease activity, a score of >11 to <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25714|NCT01672970|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant’s disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
25715|NCT01672970|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant’s Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 <3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||units on a scale||Standard Deviation|Mean
25716|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
25717|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
25718|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
25719|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.||joint count||Standard Deviation|Mean
25720|NCT01672970|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||percentage of participants|||Number
25721|NCT01672970|Secondary|Percentage of Participants on Tocilizumab Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population||percentage of participants||95% Confidence Interval|Number
25724|NCT01672970|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
25725|NCT01672970|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||days||Standard Deviation|Mean
25726|NCT01672970|Secondary|Mean Dose of TCZ at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||milligrams per kilogram {mg/kg)||Standard Deviation|Mean
25727|NCT01672970|Secondary|Number of Participants With Reasons for Dose Modification for TCZ|Only those participants that had dose modifications were reported.|6 months|FAS population||participants|||Number
25728|NCT01672970|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
25729|NCT01672970|Secondary|Percentage of Participants With Duration of Previous Biologic RA Treatments|The duration of previous biologic RA treatments was classified in to two categories: less than (<) 6 months and greater than (>) 6 months.|Baseline|Per protocol population included all participants who had a valid tocilizumab administration assessment at 6-month time window and without any protocol violations.||percentage of participants|||Number
25730|NCT01672970|Secondary|Number of Previous Biologic RA Treatments Received by Participants||Baseline|FAS population||biologic treatments|||Number
25731|NCT01672970|Secondary|Percentage of Participants With Reason for DMARDs Withdrawal at Baseline|DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
25732|NCT01672970|Secondary|Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline|DMARDs exposure was evaluated for all participants. “Prior DMARDs treatment” included participants, who were treated with DMARDs 8 weeks according to physician’s discretion before being included in the study. “DMARDs treatment at baseline” included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.|Prior to study (8 weeks) to Baseline|FAS population||percentage of participants||95% Confidence Interval|Number
25733|NCT01672970|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.|Baseline|FAS population||percentage of participants||95% Confidence Interval|Number
25734|NCT01672970|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population||percentage of participants||95% Confidence Interval|Number
25735|NCT01672957|Secondary|Percentage of Participants With Graft Survival|Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation.|Months 1, 6, and 12|Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
25736|NCT01672957|Secondary|Percentage of Participants With Acute Rejection|Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.|Baseline to Month 1, Months 2 to 6, Months 7 to 12|Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
25737|NCT01672957|Secondary|Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil|Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.|Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||percentage of participants|||Number
25738|NCT01672957|Secondary|Mean Dose of Mycophenolate Mofetil||Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.||milligrams (mg)||Standard Deviation|Mean
25739|NCT01672957|Primary|GFR at Month 12 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 12|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.||mL/min||Standard Deviation|Mean
25761|NCT01672658|Secondary|Six Minute Walk Test|Assesses distance walked over 6 minutes|Pre-training, mid training (4 weeks), post training (8 weeks)|||Feet||Standard Deviation|Mean
25762|NCT01672658|Secondary|10 Meter Walk Test|assesses walking speed of short duration|Pre-training, mid training (4 weeks), post training (8 weeks)|||m/s||Standard Deviation|Mean
25740|NCT01672957|Primary|GFR at Month 6 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 6|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.||mL/min||Standard Deviation|Mean
25741|NCT01672957|Primary|Glomerular Filtration Rate (GFR) at Month 1 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure.|Month 1|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.||mL/min||Standard Deviation|Mean
25742|NCT01672957|Primary|Creatinine Clearance at Month 12 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 12|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.||mL/min||Standard Deviation|Mean
25743|NCT01672957|Primary|Creatinine Clearance at Month 6 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 6|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.||mL/min||Standard Deviation|Mean
25744|NCT01672957|Primary|Creatinine Clearance at 1 Month After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 1|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.||mL/min||Standard Deviation|Mean
25745|NCT01672827|Primary|Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).||Percentage (True Negative)||95% Confidence Interval|Number
25746|NCT01672827|Secondary|Inter-Reader Agreement of PET Images Without Anatomic Images|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.|Post Flutemetamol Injection|||Number of inter-reader agreements|||Number
25747|NCT01672827|Primary|Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).||Percentage (True Positive)||95% Confidence Interval|Number
25748|NCT01672788|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
25749|NCT01672788|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||ng/mL||Geometric Coefficient of Variation|Geometric Mean
25750|NCT01672788|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||nmol/L||Geometric Coefficient of Variation|Geometric Mean
26028|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.~The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|first postoperative day|||units on a scale 0-10||Standard Deviation|Mean
25751|NCT01672788|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
25752|NCT01672788|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
25753|NCT01672788|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
25754|NCT01672723|Other Pre-specified|Self-reported Physical Symptoms|"At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.~Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo."|once a day for 8 days|||units on a scale||Standard Deviation|Mean
25755|NCT01672723|Secondary|Daily Self-reported Feelings of Social Connection|For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt (“I felt out of touch and disconnected from others”). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).|end of day for 8 days|||units on a scale||Standard Error|Mean
25756|NCT01672723|Primary|Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)|Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by “not at all” and “very.” Higher numbers indicate greater feelings of connection in response to reading the loving messages.|participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment|||units on a scale||Standard Error|Mean
25757|NCT01672658|Secondary|Dizziness Handicap Inventory|"A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.~Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)"|Pre-training, mid training, post training|This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.||Units on a scale||Standard Deviation|Mean
25758|NCT01672658|Secondary|Activities Balance Confidence Scale (ABC)|"Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.~16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: How confident are you that you will not lose your balance or become unsteady when you... Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items"|Pre-training, mid training, post training|||units on a scale||Standard Deviation|Mean
25759|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open|"The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.~The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.~The scores of the 3 trials are averages"|Pre-training, mid training (4 weeks), post training (8 weeks)|||sec||Standard Deviation|Mean
25760|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed|"Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.~The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.~The scores of the 3 trials are averages"|Pre-training, mid training, post training|||sec||Standard Deviation|Mean
25763|NCT01672658|Primary|Functional Gait Assessment (FGA)|"Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.~10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment~= moderate impairment~= mild impairment~= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device"|Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)|||units on a scale||Standard Deviation|Mean
25764|NCT01672658|Primary|Berg Balance Scale|The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)|||Units on a continuous scale||Standard Deviation|Mean
25765|NCT01671839|Secondary|Safe Treatment|Freedom from serious adverse events directly attributable to the Cabochon System or procedure.|Treatment to 3 years|||occurence of serious adverse events|||Number
25766|NCT01671839|Secondary|Procedure Tolerability|Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).||units on scale||Standard Deviation|Mean
25767|NCT01671839|Secondary|Subject Satisfaction|"Subject rated satisfaction according to a 5 point Likert scale after treatment:~Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied"|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).||percentage of subjects||95% Confidence Interval|Number
25768|NCT01671839|Secondary|Improved Appearance|"Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 1 year after treatment. Change in the cellulite severity was rated according to 5 measures:~Very much improved: Optimal cosmetic result in the treated areas for this subject~Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition~Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude~No Change: The appearance of the treated areas is essentially the same as the original condition~Worse: The appearance of the treated areas is worse than the original condition"|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).||percentage of subjects||95% Confidence Interval|Number
25769|NCT01671839|Secondary|Improvement in Cellulite Severity Grade|Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 year after treatment.|3-year|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing endpoint outcomes.||percentage of subjects||95% Confidence Interval|Number
25770|NCT01671839|Primary|Mean Change in Cellulite Severity|Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 1 year after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 1-year for the study population which was a minimum of 1 point lower than the baseline severity. Paired t-test test with a critical 1–sided alpha level of 0.025 was carried out on the mean Cellulite Severity Scale (0-5) change between 3 year and baseline visits.|Treatment to 3 years|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.||units on a scale||95% Confidence Interval|Mean
25771|NCT01671748|Secondary|Wound Recurrence Rate|Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.|90 days after time of healing|Three patients healed during the study period (one NLFU+SOC patient healed after 7 weeks and one after 8 weeks of NLFU+SOC treatment, and one patient who received standard care alone healed after 4 weeks). All three of these patients remained healed 90 days after the end of their study treatment.||Number of wounds remained healed|||Number
25772|NCT01671748|Primary|Actual Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|As previous||cm2||Standard Deviation|Mean
25773|NCT01671748|Secondary|Number of Non-serious Adverse Events in Each Group|Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.|Week 5 to 13|||Number of non-serious AEs|||Number
25774|NCT01671748|Secondary|Incidence of Wound Infection|Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).|Weeks 5 to 13|All patients included; ITT.||Number of infections per patient||Inter-Quartile Range|Median
25775|NCT01671748|Secondary|Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)|Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.|Weeks 5 to 13|||scores on a scale||Standard Deviation|Mean
26029|NCT01667848|Secondary|Core Temperature||one day postoperativly||||||
26030|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.~The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|operation day||||||
25776|NCT01671748|Secondary|Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)|"On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values.~CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17"|Week 1 (start) and week 13 (exit)|All patients were analysed by ITT||units on a scale||Inter-Quartile Range|Median
25777|NCT01671748|Primary|Percentage Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|All patients included in the analysis; Intention to treat (ITT); Values have been adjusted for the influence of the covariate (wound area at the start of treatment)||percentage change in wound area||Standard Deviation|Mean
25778|NCT01671293|Secondary|Change of Baseline in Waist Circumference|Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
25779|NCT01671293|Secondary|Change of Baseline in Knowledge About Prediabetes|A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
25780|NCT01671293|Secondary|Change From Baseline in Self Report of Dietary Practices|The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, & Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
25781|NCT01671293|Secondary|Change From Baseline in Total Cholesterol|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL"|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
25782|NCT01671293|Secondary|Change From Baseline in Triglycerides|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
25783|NCT01671293|Secondary|Change From Baseline in Fasting Glucose|"Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
25784|NCT01671293|Secondary|Change From Baseline in Self Report of Physical Activity|The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.|baseline and post intervention (6 -9 months after the first phone counseling session)||||||
25785|NCT01671293|Primary|Change From Baseline in Weight Parameter|Patient's weight wil be measured in kilograms using scales.|baseline and post intervention (6 -9 months after the first phone counseling session)|||kilograms||Standard Deviation|Mean
25786|NCT01671111|Secondary|Change From Baseline in Serum Ferritin Values at Specified Visits|A negative change from baseline indicates that serum ferritin decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Weeks 24 and 48 of Cycle 1, Week 24 of Cycle 2|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.||nanogram per milliliter||Standard Deviation|Mean
25787|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 2)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.||milliseconds||Standard Deviation|Mean
25788|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 48 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.||milliseconds||Standard Deviation|Mean
26031|NCT01667796|Secondary|Gene Expression Microarray|These data have not yet been generated|90 days||03/2017||||
26032|NCT01667796|Secondary|Cytokine Levels and Percentages of T and B Cells|These data have not yet been fully analyzed.|90 days||03/2016||||
25789|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.||milliseconds||Standard Deviation|Mean
25790|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 2)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.||mg/g dry tissue||Standard Deviation|Mean
25791|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 48 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.||mg/g dry tissue||Standard Deviation|Mean
25792|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal magnetic resonance imaging (MRI) data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|Full analysis set (FAS) included all participants in the Safety set who had at least 1 post-baseline primary efficacy assessment. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.||milligram per gram (mg/g) dry tissue||Standard Deviation|Mean
25793|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Pain|The VAS-Pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25794|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Morning Stiffness|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25795|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Fatigue|The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue, and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25796|NCT01671059|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ is a participant self-reported questionnaire for assessing the extent of the participant’s functional ability. It consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale is an average of all the scores and ranges from 0 to 3, where higher scores represent higher disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25797|NCT01671059|Secondary|Patient Global Assessment of Disease Activity Score|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25798|NCT01671059|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)|An AESI includes serious/medically significant infections; opportunistic infections; cases of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), in combination with either elevated bilirubin or clinical jaundice; suspected transmission of an infectious agent by the study drug; myocardial infarction /acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis / hypersensitivity reactions (including injection site reactions); demyelinating disorders; stroke; serious/medically significant bleeding events; or serious/medically significant hepatic events.|6 months|Enrolled participants.||percentage of participants|||Number
25799|NCT01671059|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response|ACR response was calculated based on total joint count evaluation and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (28 joints) and tender joint count (28 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, participant's global assessment of disease activity (PGH), physician's global assessment of disease activity (PhGH) (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale); participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity); acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50 and ACR70 require a 50% and 70% improvement from baseline, respectively.|6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
26033|NCT01667796|Primary|Change in Mean Serum Level of 25-hydroxyvitamin D|Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and HCs to take into account repeated measures and within-subject correlations.|Baseline to 90 days|||nmol/L||Standard Deviation|Mean
31084|NCT01587079|Secondary|Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1|Proportion of subjects achieving >=12% improvement in FEV1|Day 1|MITT||Percentage|||Number
25800|NCT01671059|Secondary|Clinical Disease Activity Index (CDAI) Score|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25801|NCT01671059|Secondary|Simplified Disease Activity Index (SDAI)|Simplified Disease Activity Index (SDAI) is an index for measuring disease activity in RA and has a good correlation with the DAS28. The index is calculated using the following formula: SDAI: swollen joint count (SJC28) + tender joint count (TJC28) + physician global assessment (PGA) (10 cm visual analogue scale [VAS]) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligrams/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores range from 0 to 86, with higher scores also indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25802|NCT01671059|Secondary|Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
25803|NCT01671059|Secondary|Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
25804|NCT01671059|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.||units on a scale||Full Range|Median
25805|NCT01671059|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
25806|NCT01671059|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy||6 months|Enrolled participants.||percentage of participants|||Number
25807|NCT01671059|Secondary|Percentage of Participants With Dose Interruptions||6 months|Enrolled participants.||percentage of participants|||Number
25808|NCT01671059|Secondary|Reasons for Dose Modifications||6 months|Enrolled participants who were evaluable for this outcome measure.||participants|||Number
25809|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents||Baseline|Enrolled participants.||percentage of participants|||Number
25810|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)||6 months|Enrolled participants who were evaluable for this outcome measure.||percentage of participants|||Number
25811|NCT01671059|Secondary|Percentage of Participants With Dose Modifications||6 months|Enrolled participants.||percentage of participants|||Number
25812|NCT01671059|Primary|Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation||6 months|Enrolled participants.||percentage of participants|||Number
25813|NCT01670721|Secondary|Change From Baseline in HRQL EQ-5D-3L VAS Score|EQ-5D VAS was used to record a participant’s rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Baseline corresponded to last evaluable assessment before treatment administration.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.||units on a scale||Standard Deviation|Mean
25821|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
31085|NCT01587079|Secondary|Time to Onset of Action (>10% Improvement in FEV1) on Day 1|Time to onset of action (>10% improvement in FEV1)|Day 1|MITT||Percentage|||Number
25814|NCT01670721|Secondary|Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.||units on a scale||Standard Deviation|Mean
25815|NCT01670721|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant’s assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment(either Aflibercept or FOLFIRI).Here, n=number of participants with available data at specified time-points.||units on a scale||Standard Deviation|Mean
25816|NCT01670721|Primary|Percentage of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the first dose of treatment to 30 days after the last dose of treatment (either Aflibercept or FOLFIRI). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days)|Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.||Percentage of participants|||Number
25817|NCT01670487|Primary|Pain Score on the Numeric Rating Scale (NRS)|Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.|pain of intravenous catheter placement.|adults undergoing placement of an intravenous line in the emergency department||NRS||Standard Deviation|Mean
25818|NCT01670279|Primary|Change From Baseline to Study Completion in C-SSRS Score.|The C-SSRS was one of the primary parameters to measure the safety and tolerability of individual participants. Suicidality was monitored during the trial using the C-SSRS. This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last trial visit.|Baseline, End of Titration, Fixed dose Day 14 and 28, Day 15 and 29, Early Termination, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Participants|||Number
25819|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The AIMS Scale was an EPS rating scale. The AIMS is a 12 item scale. The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
25820|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The Barnes Akathisia Rating Scale was an EPS rating scale. The Barnes Akathisia Rating Scale was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.||Units on a scale||Standard Deviation|Mean
25834|NCT01670045|Secondary|Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)|The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity’. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is ‘remission’, score > 2.8 and ≤ 10 is ‘low disease activity’, score > 10 and ≤ 22 is ‘moderate disease activity’, score > 22 is ‘high disease activity’. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.||participants|||Number
25822|NCT01670279|Primary|Incidence of Physical Examination Evaluation of Potential Clinical Significance|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Physical examination was performed at Screening, check-in, and discharge|Safety Sample was analyzed. Any clinically significant condition present at the post-treatment physical examination that was not present at the baseline examination was documented as an adverse event and followed to a satisfactory conclusion. There were no clinically significant physical examination findings reported in this study.||Participants|||Number
25823|NCT01670279|Primary|Incidence of ECG Evaluations of Potential Clinical Significance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Titratrion Day 1 and 7, Fixed dose Day 1, 14, 28, Early Termination|The safety dataset included all randomized participants who received at least one dose of study medication.||Participants|||Number
25824|NCT01670279|Primary|Incidence of Vital Signs of Potential Clinical Significance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Titration Day 1, 2, 7, 8, Fixed Days 1, 2, 14, 15, 28, 29, Early Termination and Last Visit.|The safety dataset included all randomized participants who received at least one dose of study medication.||Participants|||Number
25825|NCT01670279|Primary|Incidence of Laboratory Values of Potential Clinical Significance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Titration Day 7, Fixed dose Day 14 and 28 and Last Visit|The safety dataset included all randomized participants who received at least one dose of study medication.||Participants|||Number
25826|NCT01670279|Primary|Number of AEs Reported.|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial. AEs were measured throughout the 14-day titration and 28-day fixed dose phase until follow-up (30 [±2] days after last dose of study medication).|Throughout the study, up to 119 days|The safety dataset included all randomized participants who received at least one dose of study medication.||Events|||Number
25827|NCT01670279|Primary|Number of Participants Who Tolerated Brexpiprazole|Safety and tolerability of brexpiprazole was noted to be primary outcome measure. Brexpiprazole was judged to be tolerated if at least 6 out of 8 (75%) of the participants in a test cohort tolerated the dose after 14 days of QD dosing at the end of the fixed dose phase based on the blinded data. Dose toleration was defined as follows: during the course of the trial, the participants did not experience any moderate or severe adverse events (AEs) or potentially clinically relevant changes from Baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, Columbia-Suicide Severity Rating Scale (C-SSRS), or extrapyramidal symptom (EPS) ratings, which were assessed as possibly related to the study drug, and would have warranted a dose decrease or discontinuation of the study drug. The safety and tolerability of brexpiprazole was defined by parameters: AEs, laboratory values, vital signs, ECG, C-SSRS, or EPS ratings, the results of each of the parameters reported separately.|45 Days|Tolerability assessed in phase 1 trial in healthy participants (18-45 years) with MDD as adjunct therapy to ADTs; the efficacy assessed in phase 3 trials in participants (18-65 years) with MDD as adjunct therapy to ADTs. Thus, safety/tolerability of brexpiprazole in participants (>65 years) with MDD as adjunct therapy to ADTs was not characterized.||participants|||Number
25828|NCT01670201|Primary|Percentage of Participants Who Had > 95 % Epithelialization at Day 10||10 days|||percentage of participants|||Number
25829|NCT01670201|Secondary|Pain at Dressing Changes|"The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.~Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),~Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst."|28 days|||units on a scale VAS 0-100||Full Range|Median
25830|NCT01670045|Secondary|Percentage of Participants With Tocilizumab Dose Modifications||Baseline up to Month 6|ITT.||percentage of participants|||Number
25831|NCT01670045|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.|Baseline, Months 3, 6|"ITT. Here number of participants analyzed included evaluable participants for the outcome measure and n included evaluable participants at specified time point."||mm||Standard Deviation|Mean
25832|NCT01670045|Secondary|Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids|Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.|Baseline, up to Month 6|ITT.||participants|||Number
25833|NCT01670045|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria|ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].|Month 1, 2, 3, 4, 5, 6|ITT.||percentage of participants|||Number
25835|NCT01670045|Secondary|Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)|The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity’. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is ‘remission’, score > 3.3 and ≤ 11 is ‘low disease activity’, score > 11 and ≤ 26 is ‘moderate disease activity’, score > 26 is ‘high disease activity’. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.||participants|||Number
25836|NCT01670045|Secondary|Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >1.2 points, score of >5.1 and DAS28 improvement of >1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of >3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of >5.1 and DAS28 improvement of >0.6 to ≤1.2 points, score of >5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.|Baseline up to Month 6|ITT.||participants|||Number
25837|NCT01670045|Secondary|Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline|The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant’s global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.|Baseline, Month 1, 2, 3, 4, 5, 6|ITT.||percentage of participants|||Number
25838|NCT01670045|Secondary|Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status|"Percentage of participants with anti-CCP status were reported as positive, negative and unknown."|Baseline up to Day 5|ITT.||percentage of participants|||Number
25839|NCT01670045|Secondary|Percentage of Participants With Rheumatoid Factor Status|"Percentage of participants with rheumatoid factor status was reported as positive or negative."|Baseline up to Day 5|ITT.||percentage of participants|||Number
25840|NCT01670045|Secondary|Percentage of Participants With Different Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.|Baseline up to Day 5|ITT.||percentage of participants|||Number
25841|NCT01670045|Secondary|Percentage of Participants With RA Diagnosis|"Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under unknown."|Baseline up to Day 5|ITT.||percentage of participants|||Number
25842|NCT01670045|Primary|Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation||Month 6|ITT.||percentage of participants|||Number
25843|NCT01670019|Secondary|Rates of Sustained Remission|"Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS < 7) is present.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|2, 4, 6 weeks|Participants that completed all data collection timepoints at week 2, 4, 6.||participants|||Number
25844|NCT01670019|Secondary|Clinical Remission Rate|"Clinical Remission will be defined as the number of participants with a MADRS total score < 7.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|6 weeks|||participants|||Number
25845|NCT01670019|Secondary|Clinical Response Rate|"Clinical Response rate will be defined as the number of participants with a > 50% reduction from baseline in MADRS total score.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks|||participants|||Number
25846|NCT01670019|Secondary|Study Completion Rate|The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks|6 weeks|||percentage of participants|||Number
25847|NCT01670019|Primary|Change in MADRS Total Score|"The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks|Analysis includes those participants who completed week 6 assessment.||units on a scale||Standard Deviation|Mean
25848|NCT01669902|Secondary|Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study||Baseline to Month 6|Safety Analysis Set||participants|||Number
25849|NCT01669902|Secondary|Percentage of Participants With Concomitant Corticosteroids Treatment||Baseline to Month 6|Safety Analysis Set||percentage of participants|||Number
25907|NCT01669122|Secondary|Time to Maximum Plasma Concentration (Tmax)|Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||hours||Full Range|Median
31086|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Treatment Day 1|Peak change from Baseline in FEV1 on Treatment|Day 1|MITT||Milliliters||95% Confidence Interval|Least Squares Mean
25850|NCT01669902|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 3 and Month 6|The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.||units on a scale||Standard Deviation|Mean
25851|NCT01669902|Secondary|Percentage of Participants With Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (>) 240 minutes, or whole day.|Baseline, Month 3, Month 6|FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25852|NCT01669902|Secondary|Percentage of Participants With Morning Stiffness|The percentage of participants with morning stiffness (“yes”, “no”, or “do not know”) was assessed at each visit.|Baseline, Month 3, Month 6|FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25853|NCT01669902|Secondary|Patient Global Assessment of Pain|Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.|Baseline, Month 3, Month 6|The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.||mm||Standard Deviation|Mean
25854|NCT01669902|Secondary|Percentage of Participants in a PGA of Disease Activity Score Category|A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.|Baseline, Month 3, Month 6|FAS (categorical scale [physician]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25855|NCT01669902|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [physician] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.||mm||Standard Deviation|Mean
25856|NCT01669902|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [patient]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.||mm||Standard Deviation|Mean
25857|NCT01669902|Secondary|Number of Participants With an American College of Rheumatology (ACR) Response|ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.|Baseline to Month 6|Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.|||||
25858|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3 and Month 6|FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25859|NCT01669902|Secondary|Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
25860|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Month 3 and Month 6|FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25908|NCT01669122|Secondary|AUC(0-inf)|Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined. AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||ng*hr/mL||Standard Deviation|Mean
31087|NCT01587079|Primary|FEV1 AUC 0-12 on Day 7|FEV1 AUC 0-12|Day 7|MITT||Liters||95% Confidence Interval|Least Squares Mean
25861|NCT01669902|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
25862|NCT01669902|Secondary|Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)|The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25863|NCT01669902|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)|The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25864|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25865|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [ESR]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [ESR] assessment. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
25866|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) < 2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.||percentage of participants|||Number
25867|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (<= 3.2) implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (<) 2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [CRP]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [CRP] assessment. n = participants evaluable for this measure at specified timepoint.||Units on a scale||Standard Deviation|Mean
25868|NCT01669902|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.||tender joint count||Standard Deviation|Mean
25869|NCT01669902|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.||swollen joint count||Standard Deviation|Mean
25870|NCT01669902|Secondary|Percentage of Participants With Dose Modifications of Tocilizumab|Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.|Baseline to Month 6|Safety Analysis Set||percentage of participants|||Number
25871|NCT01669902|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6||Month 6|Safety Analysis Set||percentage of participants|||Number
25872|NCT01669863|Other Pre-specified|Change in Oxygenation Index During Application of ECMO|Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay|Duration of ICU stay|Data for this outcome were not collected. We intended to measure the PaO2/FiO2 ratio in all patients anticipating that all patients would be mechanically ventilated, either invasively or non-invasively. However, it turned out that most patients did not require mechanical ventilation while on ECMO.|||||
25873|NCT01669863|Secondary|Number of Participants Who Presented With ECMO-Related Complications|ECMO-related complications|Duration of ICU stay|||participants|||Number
25874|NCT01669863|Primary|Number of Participants That Did Not Require Endotrachael Intubation|- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.|Duration of ICU stay|||participants|||Number
25875|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -sleep disturbance at baseline were included.||Percentage of participants|||Number
25876|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -difficulty of swallowing at baseline were included.||Percentage of participants|||Number
25877|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -abdominal pain at baseline were included.||Percentage of participants|||Number
25878|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -acid regurgitation at baseline were included.||Percentage of participants|||Number
25879|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -heartburn at baseline were included.||Percentage of participants|||Number
25880|NCT01669811|Secondary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 4 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 4 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Number
25881|NCT01669811|Primary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 8 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 8 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|8 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Number
31088|NCT01587027|Primary|Adverse Events.|Adverse event data was evaluated for incidence and severity for 6 days.|6 days.|All enrolled participants were analyzed for adverse events.||Events|||Number
25882|NCT01669785|Secondary|Long-term Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days post-prophylaxis treatment.|||units on a scale||Standard Deviation|Mean
25883|NCT01669785|Secondary|Post-prophylaxis Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately following post-prophylaxis treatment.|||units on a scale||Standard Deviation|Mean
25884|NCT01669785|Secondary|Post- Scaling Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Post-scaling procedure,immediate|||units on a scale||Standard Deviation|Mean
25885|NCT01669785|Primary|Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score Schiff air blast measurements long term after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.|||units on a scale||Standard Deviation|Mean
25886|NCT01669785|Primary|Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score via air blast measurements immediately after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .|||units on a scale||Standard Deviation|Mean
25887|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Air Blast Sensitivity)|"Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement|||units on a scale||Standard Deviation|Mean
25888|NCT01669785|Secondary|Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity prior to the baseline assessments.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-Treatment|||units on a scale||Standard Deviation|Mean
25889|NCT01669785|Primary|Long-term Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile measurements long term after treatment.~Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.|||grams||Standard Deviation|Mean
25909|NCT01669122|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||ng/mL||Standard Deviation|Mean
28171|NCT01636778|Secondary|Mean Weight at the Indicated Time Points During Follow-up Period After Part 2|The weight of participants was recorded at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population||kg||Standard Deviation|Mean
25890|NCT01669785|Primary|Immediate Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .|||grams||Standard Deviation|Mean
25891|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Tactile Sensitivity)|"Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement|||grams||Standard Deviation|Mean
25892|NCT01669720|Secondary|Adverse Events for Patients Receiving Adjuvant Aflibercept, up to 2-years of Duration, for Patients Who Previously Received Systemic Chemotherapy and Surgical Resection/Ablation.||Every 2 weeks for up to 2 years||||||
25893|NCT01669720|Primary|Number of Patients Who Progressed|Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.|Every 3 months until disease progression (for up to 2 years).|||participants|||Number
25894|NCT01669629|Secondary|Overall Corneal Staining|"Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.~Grade 1 or higher is reported as a percentage of total eyes."|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.||percentage of eyes|Participants||Number
25895|NCT01669629|Secondary|Binocular Snellen Visual Acuity|Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.||percentage of eyes|Participants||Number
25896|NCT01669629|Secondary|Subject Reported Overall Vision|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.|6-10 Days|||percentage of participants|||Number
25897|NCT01669629|Secondary|Subject Reported Overall Comfort|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.|6-10 Days|||percentage of participants|||Number
25898|NCT01669629|Primary|Subject Reported Ease of Removal|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.|6-10 Days|Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.||percentage of participants|||Number
25899|NCT01669577|Primary|Death|30 days after trauma mortality evaluation|Within the first 30 days|severe polytrauma patients (ISS>15)||participants|||Number
25900|NCT01669174|Secondary|AUC0-56 and AUClast|AUC0-56, the area under the serum concentration-time curve from the time zero to the end of the dosing interval, day 56. AUC0-56 was analyzed for dose 1 and 2. AUClast is from time zero to the last quantifiable concentration. AUClast was analyzed for dose 2 only.|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||day*ug/mL||Standard Deviation|Mean
25901|NCT01669174|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|The time to reach the maximum concentration after drug administration|24 weeks|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||hr||Full Range|Median
25902|NCT01669174|Secondary|Maximum Observed Serum Concentration (Cmax)|The observed maximum plasma concentration following drug administration|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||ug/mL||Standard Deviation|Mean
25903|NCT01669174|Secondary|Change in 6 Minute Walk Distance Compared to Placebo|Practical simple test that requires a 100-ft hallway but no exercise quipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD)|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame||meter||Standard Deviation|Mean
25904|NCT01669174|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 4,8,16 and 24 was considered responders.|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.||Percentage Change of TMV||Standard Deviation|Mean
25905|NCT01669122|Secondary|Plasma Half Life (t1/2)|Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||hours||Standard Deviation|Mean
25906|NCT01669122|Secondary|Rate of Elimination (Kel)|Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||1/ hour||Standard Deviation|Mean
25910|NCT01669122|Primary|Area Under the Curve From Time 0 to t, AUC (0-t)|Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|Per protocol (PP) population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.||nanograms (ng)*hours (h)/milliliter (mL)||Standard Deviation|Mean
25911|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~-max elasticity of clot on thromboelastography"|30 days post-treatment|||"Pascal"||Standard Deviation|Mean
25912|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- slope of clot formation dynamics"|30 days post-treatment|||"Pascal/min"||Standard Deviation|Mean
25913|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~-dynamics of clot formation: clot onset time and clot complet"|30 days post-treatment|||"sec"||Standard Deviation|Mean
25914|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~RAGE gene expression~Arbitrary unit was relative to the control gene expression (control gene = 1)"|30 days post-treatment|||arbitrary unit relative to control gene||Standard Deviation|Mean
25915|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estrone and Norepinephrine.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- estrone, norepinephrine."|30 days post-treatment|||"pg/dL"||Standard Deviation|Mean
25916|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Biomarkers|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone."|30 days post-treatment|||"microUI/mL"||Standard Deviation|Mean
25917|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Platelet Aggregation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- platelet aggregation by ADP and norepinephrine."|30 days post-treatment|||percentage platelet aggregation||Standard Deviation|Mean
25918|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estradiol|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- estradiol"|30 days post-treatment|||"pg/mL"||Standard Deviation|Mean
25919|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Apolipoproteins AI and B.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- apolipoproteins AI and B"|30 days post-treatment|||"g/dL"||Standard Deviation|Mean
25920|NCT01668836|Primary|Sirtuin|Sirtuin plasma levels before and 30 days post-treatment|30 days post-treatment|||ng/mL||Standard Deviation|Mean
25921|NCT01668836|Other Pre-specified|Differences Between Men and Women.|We will also compare women vs men baseline and final data.|30 days||||||
25922|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose."|30 days post-treatment|||"mg/dL"||Standard Deviation|Mean
25923|NCT01668836|Primary|Direct Evaluation of the Sirtuin 1 Gene Expression|"The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. Arbitrary unit was relative to the control gene expression (control gene = 1)."|30 days post-treatment|||arbitrary unit relative to control gene||Standard Deviation|Mean
25924|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25925|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
28434|NCT01632423|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
25926|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25927|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25928|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25929|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25930|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25931|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25932|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
26034|NCT01667731|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
25933|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25934|NCT01668797|Other Pre-specified|Mean Change From Baseline in PEC Score - LOCF Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25935|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Excited Component (PEC) Score - MMRM Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The last-observation-carried-forward (LOCF) data set included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data (eg.the last visit prior to the first dosing of Phase C) were not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25936|NCT01668797|Other Pre-specified|Percentage of Participants Who Discontinued Due to All Causes|Analysis of the percentage of participants who discontinued due to all causes was based on all participants who have been randomized and taken one dose of IMP in the Double-blind Maintenance phase. The trial was completed by sponsor when efficacy was demonstrated at the first pre-specified interim analysis (45 impending relapse events) performed by an independent (unblinded) statistician.|Baseline to Week 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Percentage of particpants|||Number
25937|NCT01668797|Other Pre-specified|Mean Change From Baseline in GAF Scale Score - LOCF Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25938|NCT01668797|Other Pre-specified|Mean Change From Baseline in Global Assessment of Functioning (GAF) Scale Score - MMRM Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25939|NCT01668797|Other Pre-specified|Mean Change From Baseline in PSP Scale Score - LOCF Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25968|NCT01668654|Secondary|Area Under the Plasma Concentration-time Curve (AUC) Following Oral Administration of Retigabine/Ezogabine at the Indicated Time Points|AUC is defined as the area under the plasma drug concentration-time curve, reflects the actual body exposure to drug after administration of a dose of the drug and is expressed in milligram*hour per Liter (mg*h/L). Blood samples for population PK analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
26098|NCT01666782|Secondary|Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.|Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine|28 days|||participants|||Number
25940|NCT01668797|Other Pre-specified|Mean Change From Baseline in Personal and Social Performance (PSP) Scale Score - MMRM Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25941|NCT01668797|Other Pre-specified|Clinical Global Impression - Improvement Score (CGI-I) at Endpoint - LOCF Analysis|The rater or investigator would rate the participant's total improvement whether or not it is due entirely to study treatment. During Phase B, responses were compared to the participant's condition at Baseline of Phase B (for participants who entered Phase B directly after screening) or to the End of Phase A visit (for participants who participated in Phase A). During Phase C, responses were compared to the participant's condition at the End of Phase B visit. Response choices include: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse.|Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Deviation|Mean
25942|NCT01668797|Other Pre-specified|Change From Baseline in CGI-S Score at Endpoint - LOCF Analysis|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25943|NCT01668797|Other Pre-specified|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint - MMRM Analysis|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25944|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - LOCF Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25945|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25946|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - LOCF Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25947|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - MMRM Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25948|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Total Score - Last-observation-carried-forward (LOCF) Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.||Units on a scale||Standard Error|Least Squares Mean
25949|NCT01668797|Other Pre-specified|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Units on a scale||Standard Error|Least Squares Mean
25950|NCT01668797|Other Pre-specified|Percentage of Participants Meeting Stability Criteria in Double Blind Maintenance Phase|Participants were assessed for stability using the following criteria:1) Outpatient status AND 2) Positive and Negative Syndrome Scale (PANSS) Total Score ≤ 70 AND 3) A score of ≤ 4 (moderate) on each of the following PANSS items (possible scores of 1 to 7 for each item): conceptual disorganization, suspiciousness hallucinatory behavior, unusual thought content, AND 4) Clinical Global Impression - Severity of Illness scale(CGI-S) score ≤ 4 (moderately ill) AND 5) No current suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), defined as the following: An answer of “no” to each question on the Suicidal Behavior section of the C-SSRS AND an answer of “no” to Questions 4 and 5 on the Suicidal Ideation section of the C-SSRS, if completed, AND 6) No evidence of aggressive or violent behavior resulting in clinically significant self-injury, injury to another person, property damage.|Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||percentage of participants|||Number
25951|NCT01668797|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria in the Double-blind Maintenance Phase|"Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual though content) to a score of >4 and an absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Current suicidal behavior as assessed by the C-SSRS (ie, an answer of yes to any of the questions on the suicidal behavior section of the C-SSRS 5) Violent or aggressive behavior resulting in clinically significant self-injury to another person, or property damage."|Baseline and Week 52/Early Termination|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||percentage of participants|||Number
25952|NCT01668797|Primary|Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C.|The primary efficacy variable was time to impending relapse from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score >4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content).OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.The measure type, number is Hazard Ratio.|From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks|Based on the Intent-to-Treat (ITT) principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.||Days||95% Confidence Interval|Number
26015|NCT01668173|Primary|Overall Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|||participant with Stable Disease|||Number
25953|NCT01668784|Secondary|Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units|Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: < 8.0 g/dL), Platelet Count (Gr 3: 25.0 -< 50.0*10^9 c/L; Gr 4: < 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -< 2.0*10^3 c/µL; Gr4: < 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -< 0.5*10^3 c/µL; Gr 4: < 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - < 1.0*10^3 c/µL; Gr 4: < 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), AST (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), ALT (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), tBIL (Gr 3: > 3.0 - 10.0 mg/dL * ULN; Gr 4: > 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: > 3.0 - 6.0 mg/dL *ULN; Gr4: > 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus and at least one measureable on-treatment measurement of the corresponding laboratory parameter||participants|||Number
25954|NCT01668784|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests at Primary Endpoint|Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants who received at least one dose of nivolumab or everolimus and had at least one measureable on-treatment measurement of the corresponding laboratory parameters||participants|||Number
25955|NCT01668784|Secondary|Percentage of Participants With Disease-related Symptom Progression (DRSP) at Primary Endpoint|Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
25956|NCT01668784|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events at Primary Endpoint|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day of first dose to 30 days post final dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus||participants|||Number
25957|NCT01668784|Secondary|Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level at Primary Endpoint|Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&E process before the tumor biopsy specimen was sent for evaluation or from H&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.|Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)|PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline||months||95% Confidence Interval|Median
25958|NCT01668784|Secondary|Investigator-assessed Time of Progression-free Survival (PFS) at Primary Endpoint|PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: >=20% increase in sum of target lesion diameters and sum must show absolute increase of >=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||months||95% Confidence Interval|Median
25959|NCT01668784|Secondary|Investigator-assessed Time to Objective Response at Primary Endpoint|Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.|Randomization to date of first response, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.||months||Full Range|Median
26099|NCT01666782|Secondary|Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.|Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days|||participants|||Number
25960|NCT01668784|Secondary|Investigator-assessed Duration of Objective Response at Primary Endpoint|Duration of objective response is defined as the time from first response (complete response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.|From date of first response to date of disease progression or death or censoring if no progression or death occurred, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that were randomized to any treatment group in the study and that had a response.||months||95% Confidence Interval|Median
25961|NCT01668784|Secondary|Investigator-assessed Objective Response Rate (ORR) at Primary Endpoint|ORR=number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.|At 8 weeks post randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
25962|NCT01668784|Primary|Overall Survival (OS) at Primary Endpoint|"Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p < 0.0148) was crossed while no new safety signals that would affect continuation of the study were found.~The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria."|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.||months||95% Confidence Interval|Median
25963|NCT01668667|Secondary|The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment||12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||percentage of participants|||Number
25964|NCT01668667|Secondary|The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~This model only includes treatment in the model. Least squares mean is used for analysis."|Baseline, 12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||units on a scale||Standard Error|Least Squares Mean
25965|NCT01668667|Primary|The Proportion of Subjects at the End of Treatment Who Are Responders With Either “Much Improved” or “Very Much Improved” on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|12 weeks|mITT (modified intent to treat) population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||percentage of participants|||Number
25966|NCT01668667|Primary|The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~Change from Baseline = LOCF value at current visit – value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.~The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate."|Baseline, 12 weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.||units on a scale||Standard Error|Mean
25967|NCT01668654|Secondary|Apparent Clearance (CL/F) Following Oral Administration of Retigabine/Ezogabine at Indicated Time Points|Blood samples for population pharmacokinetic analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. CL/F, where CL is the calculated as dose/AUC and F is the oral bioavailability of the drug. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled|Eligbility Assessment (Visit 1), up to 178 days|All Subjects Population|||||
26025|NCT01667900|Primary|Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.||hours||Full Range|Median
25969|NCT01668654|Secondary|Change From Baseline in Child Health Status as Measured by the Child Health Questionnaire (CHQ) in Participants <18 Years Old at the Indicated Time Points|The CHQ comprises scales specifically developed for children and adolescents aged five years and older. The CHQ assesses a child's physical, emotional, and social well-being from the perspective of a parent or guardian. The questionnaire was completed by a parent/caregiver and administration time was approximately 30 minutes. The parent/caregiver completed this questionnaire while the participant was within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibilty Assessment (Visit 1), EW Visit and FU Visit (up to 178 days)|All Subjects Population|||||
25970|NCT01668654|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI-Improvement (CGI-I) scale which rated the change from Baseline. The CGI-S was a 7-point scale that required the investigator to rate the severity of the participant’s epilepsy relative to the investigator’s past experience with other participants with the same diagnosis. The CGI-S scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=normal, 2=borderline, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
25971|NCT01668654|Secondary|Clinical Global Impression- Improvement (CGI-I) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI- Improvement (CGI-I) scale which rated the change from Baseline. The CGI-I scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
25972|NCT01668654|Secondary|Number of Participants Who Were Responders During the Treatment Period|A ''responder'' is defined as >50% reduction from Baseline in the seizure frequency. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
25973|NCT01668654|Secondary|Percent Change From Baseline in the Seizure Frequency at the Indicated Time Points|The percentage reduction from Baseline in the seizure frequency was summarized using descriptive statistics. The frequencies and percentages were computed for a reduction in seizure frequency of >50% as well as for a 100% reduction (seizure-free). Increases of >50% in seizure frequency was also summarized. The percentage of seizure-free days wasere also analyzed. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Basline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
25974|NCT01668654|Primary|Number of Days of Exposure to Retigabine/Ezogabine TID by Individual Participant|Total number of days each participant was exposed to Retigabine/Ezogabine are recorded here.|Treatment Phase plus Taper Phase (up to 97 days)|All Subjects Population||Days|||Number
25975|NCT01668654|Primary|Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study|The number of participants who advanced a stage between the eligibility visit and the EW Visit was recorded. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs. The investigator assessed the participant's sexual development in participants <18 years old based on the Tanner Stages of Puberty.|Eligibility Assessment (Visit 1) and EW Visit|All Subjects Population||Participants|||Number
25976|NCT01668654|Primary|Changes From Baseline in Learning as Measured by the Wide Range Assessment of Memory and Learning , 2nd Edition (WRAML2) at the Indicated Time Points|The WRAML2 is a standardized test that measures an individual’s memory functioning. It evaluates both visual and verbal, immediate and delayed memory ability along with the acquisition of new learning. The WRAML2 core battery is composed of two verbal, two visual, and two attention concentration subtests, yielding a verbal memory index, a visual memory index and an attention-concentration index. Together, these tests yield the general memory index. The administration time is approximately 40 minutes. During the study, this test was administered if the participant was within the age range (i.e. >9 years). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure Baseline cognition, behavior, and learning so changes from Baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
25977|NCT01668654|Primary|Changes From Baseline in Behaviour as Measured by the Child Behavior Checklist (CBCL) at the Indicated Time Points|The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The checklist is comprised of a number of statements about the child's behavior, e.g. acts too young for his/her age. Responses were recorded on a likert scale: 0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true. The preschool checklist contained 100 questions and the school-age checklist contained 120 questions. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
25978|NCT01668654|Primary|Changes From Baseline in Cognition as Measured by the Leiter-R at the Indicated Time Points|he Leiter International Performance Scale or simply Leiter is an intelligence test for children and adolescents, with norms ranging from 2 to 20 years. For all ages, it yields an intelligence quotient (IQ) and a measure of logical ability. It is comprised of ten subtests, seven of which were relevant to the 12-18 years age group. The administration time was approximately 40 minutes. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <20 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population|||||
25979|NCT01668654|Primary|Changes From Baseline in Bladder Volume as Assessed by the Post Void Residual (PVR) Ultrasound at the Indicated Time Points|The PVR urine test measured the amount of urine left in the bladder after urination. The PVR bladder ultrasound was performed by an urologist, a qualified technician or by an appropriately trained qualified study nurse at Visits 1, 6, and the EW Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 6, EW Visit|All Subjects Population|||||
25980|NCT01668654|Primary|Number of Partcipants With Hematology, Chemistry and Urinalysis Parameters Outside the Normal Ranges and Pre-determined Clinically Important Ranges|Clinical laboratory assessment included hematology, chemistry and urinalysis parameters. Clinical laboratory parameters were measured at Visit 1, 4, 5, 6, 7, EW and FU Visit. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25981|NCT01668654|Primary|Change From Baseline in the Red Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. The red blood cell count was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25982|NCT01668654|Primary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle hemoglobin was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25983|NCT01668654|Primary|Change From Baseline in the Mean Corpuscle Volume and Mean Platelet Volume Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle volume and mean platelet colume parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25984|NCT01668654|Primary|Change From Baseline in the Hematocrit Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Hematocrit was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25985|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and Red Cell Distribution Width (RDW) Percentages at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, total neutrophils and red cell distribution width (RDW) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25986|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and White Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils (Total absolute neutrophil count- total ANC), and white blood cell count parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25987|NCT01668654|Primary|Change From Baseline in Thyroid Stimulating Hormone (TSH) and Urine Albumin Measurements at the Indicated Time Points|Clinical laboratory assessments included measurements of endocrine and urinalysis parameters. TSH and urine albumin parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25988|NCT01668654|Primary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid, and Urine Creatinine Concentration Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Creatinine, direct bilirubin, indirect bilirubin, total bilirubin, uric acid, and urine creatinine concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25989|NCT01668654|Primary|Change From Baseline in Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorus, Potassium, Sodium, and Urea/BUN Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Calcium, carbon dioxide content/bicarbonate, chloride, cholesterol, glucose, magnesium, inorganic phosphorus, potassium, sodium, and urea/BUN parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25990|NCT01668654|Primary|Change From Baseline in the BUN/Creatinine and the Urine Albumin/Creatinine Ratios at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Blood Urea Nitrogen (BUN)/Creatinine and Urine Albumin/Creatinine were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25991|NCT01668654|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Albumin, total protein, hemoglobin, and mean corpuscle hemoglobin concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25992|NCT01668654|Primary|Change From Baseline in ALT, ALP, AST, CK, and LDH Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Alanine amino transferase (ALT), alkaline phosphotase (ALP), aspartate amino transferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25993|NCT01668654|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings Based on Investigator Judgment at Anytime During the Study|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visit andthe EW Visit after having kept a participant at rest in this position for 10 minutes. Abnormal findings were analyzed as clinically significant (CS) and not clinically significant (NCS). The study investigator judged the ECG abnormailities as CS or NCS.|Eligibility Assessment and EW Visit|All Subjects Population||Participants|||Number
25994|NCT01668654|Primary|Change From Baseline in Electrocardiogram (ECG) at the Indicated Time Points|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visitand the EW Visit after having kept a participant at rest in this position for 10 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days)|All Subjects Population|||||
25995|NCT01668654|Primary|Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points|BMI is calculated as weight in kilograms (kg) divided by the square of their height in metres (m^2). BMI was measured at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25996|NCT01668654|Primary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25997|NCT01668654|Primary|Change From Baseline in Body Height at Indicated Time Points|Body height was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25998|NCT01668654|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Vital sign assessment included body temperature measurements at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
25999|NCT01668654|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign assessment included heart rate measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
26000|NCT01668654|Primary|Change From Baseline in SBP and DBP at the Indicated Time Points|Vital sign assessment included SBP and DBP measurements. SBP and DBP were measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||||
26001|NCT01668654|Primary|Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study|Vital sign assessment included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements. SBP, DBP and heart rate were measured at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit after the participants were in the seated position for 5 minutes.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||Participants|||Number
26002|NCT01668654|Primary|Number of Participants With AEs Leading to Withdrawal|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of the Follow-Up Visit (up to 178 days)|All Subjects Population||Participants|||Number
26003|NCT01668654|Primary|Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of Follow-Up (up to 178 days)|All Subjects Population: all participants who enrolled in the study.||Participants|||Number
26004|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients|Quality of life was measured via scores of KDQOL SF1.3. Hydration status was measured via body composition monitor as an Overhydration (OH) value Depression was assessed using Beck depression inventory (BDI) score|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure.||units on a scale||Standard Deviation|Mean
26026|NCT01667900|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
26027|NCT01667848|Secondary|Core Temperature|core temperature during laparoscopic cholecystectomy using a rectal probe|during operation|||degree celsius||Standard Deviation|Mean
26100|NCT01666782|Secondary|Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.|Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days|||participants|||Number
26005|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients|"Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.~Health-related quality of life (HRQOL) is measured via scores of KDQOL SF1.3. Depression was assessed using Beck Depression Inventory (BDI) score. Visit 2 period is followed 12 months after Visit 1 period. HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.~Physical health score, mental health score and kidney disease health score are averaged scores of subscales.~The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.~The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms.~The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure.||units on a scale||Standard Deviation|Mean
26006|NCT01668628|Primary|Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period|"Health-related quality of life (HRQOL) is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period.~KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.~Visit 2 period is followed 12 months after Visit 1 period. The outcome measure is the difference in averaged scores between Visit 1 and Visit 2; It is calculated as (Score at visit 2 - Score at visit 1).~HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.~Physical health score, mental health score and kidney disease health score are averaged scores of subscales.~The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.~The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation.||units on a scale||Standard Deviation|Mean
26007|NCT01668589|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.||percent change||Standard Deviation|Mean
26008|NCT01668589|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same body side and machine type.||percent change||Standard Deviation|Mean
26009|NCT01668589|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.||percent change||Standard Deviation|Mean
26010|NCT01668589|Secondary|Percentage of Participants Who Received Denosumab Injections Within the Specified Window|The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.|24 months|Full analysis set||percentage of participants|||Number
26011|NCT01668589|Secondary|Time to Non-persistence With Denosumab Injection|Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.|24 months|Full analysis set who were non-persistent at 24 months||months||Inter-Quartile Range|Median
26012|NCT01668589|Primary|Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months|"MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.~MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.~It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%."|From baseline to 12 months and 24 months|Full analysis set||percentage of days of coverage||95% Confidence Interval|Mean
26013|NCT01668589|Primary|Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months|"A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).~A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart)."|12 months and 24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
26014|NCT01668589|Primary|Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months|"A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).~A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart)."|12 months and 24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
28596|NCT01629134|Secondary|Ease of Injection|Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
26016|NCT01668004|Secondary|Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM|The percentage of participants with ASDAS clinically important improvement (ASDAS-CII; ≥ 1.1 units) and major improvement (ASDAS-MI; ≥ 2.0 units) at 3 months were determined. The ASDAS incorporates three items from the BASDAI (spinal pain, duration of morning stiffness, and peripheral joint pain or swelling) each assessed on a VAS (0 to 10 cm; increasing severity) as well as patient global assessment of disease activity (VAS; 0 to 10 cm; increasing severity) and a laboratory measure of inflammation (CRP level [mg/L] or ESR [mm/hr]). ASDAS was calculated using the formula: 0.12*Spinal Pain + 0.06*Duration of Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*ln(CRP (mg/L) +1). A decrease in ASDAS at 3 months relative to BL signifies an improvement in physical function; ASDAS-MI (≥ 2.0 units decrease from BL) signifies a comparatively greater improvement in physical function than ASDAS-CII (≥ 1.1 units decrease from BL).|BL, Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (ASDAS).||Percentage of participants|||Number
26017|NCT01668004|Secondary|Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM|The percentage of participants with a BASDAI 50 response (defined as a 50% improvement or as an absolute improvement of 2 points in their BASDAI physical function score) at three months was determined. The BASDAI consists of total of six visual analog scales (VAS): five VAS (0 to 10 cm; increasing severity) measuring severity of fatigue, spinal pain, peripheral joint pain or swelling, localized tenderness, and severity of morning stiffness and one VAS (0 to 10 cm; increasing duration up to 2 hours) measuring duration of morning stiffness. The morning stiffness scores are averaged and summed with the scores for the remaining four items resulting in a composite score (0-50); the final BASDAI score (0-10) is derived by dividing by 5.|Baseline (BL), Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (BASDAI 50).||Percentage of participants|||Number
26018|NCT01668004|Secondary|Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|IBD (Crohn's disease or ulcerative colitis) and psoriaris are extra-articular manifestations of AS involving the intestinal tract and skin, respectively. The annual incidence rates of new-onset or flares of IBD and psoriasis were to be determined separately (i.e., for each condition) over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|The incidence rates for new onset or flares of IBD and psoriasis could not be evaluated due to limitations of the data collected; occurrence of flares was not collected (specifically, history of IBD and/or psoriasis could not be distinguished from flares of IBD and/or psoriasis) and, therefore, results could not be determined.|||||
26019|NCT01668004|Primary|Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|Uveitis is an extra-articular manifestation of AS involving inflammation of the eye. The annual incidence rate of new uveitis attacks was determined over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose. All participants were counted as contributing a full year of GLM exposure even if discontinuing early. Due to ongoing uveitis cases at time of period entry, participants did not have the same risk of new events during the one year periods. Participants with ongoing uveitis at start of GLM who had the adverse event for the entire treatment period were counted as having the 'new attack' before and no “new attack” after GLM treatment start.|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (incidence of uveitis). One participant for whom the timing of uveitis events could not be determined was excluded from the analysis.||Events per 100 participant years|||Number
26020|NCT01668004|Primary|Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|Uveitis is an extra-articular manifestation of ankylosing spondylitis (AS) involving inflammation of the eye. The occurrence rate (assessed as present/absent) of uveitis attacks was determined over two 1-year long periods regardless of whether the event started during the assessed year: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (occurence of uveitis).||Ratio|||Number
26021|NCT01667978|Primary|AUC Norethindrone|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21|following 21 days of continuous ingestion|2 withdrew because unable to present for study visit and another changed her medication||ng*h/mL||Full Range|Mean
26022|NCT01667900|Secondary|Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])|Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.|Baseline and Days 3, 24, and 29|Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.||millimoles*hours per liter (mmol*h/L)||Standard Deviation|Mean
26023|NCT01667900|Primary|Pharmacokinetics: Half-life of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.||hours||Full Range|Geometric Mean
26024|NCT01667900|Primary|Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
31249|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline||Month 3|||participants|||Number
26035|NCT01667731|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
26036|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
26037|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
26038|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
26039|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
26040|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
26041|NCT01667731|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
26042|NCT01667731|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
26043|NCT01667731|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug||percentage of participants|||Number
26044|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.||% sensitivity|||Number
26045|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.||% specificity|||Number
26046|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions|"For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined tissue-segments) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique."|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)||% sensitivity|Lymph Node Segments|90% Confidence Interval|Number
26047|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland|For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined “tissue-segments”) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)||% sensitivity|Prostate Segments|90% Confidence Interval|Number
26048|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes|For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.||% sensitivity||90% Confidence Interval|Number
26049|NCT01667536|Primary|Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.|For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)||% sensitivity||90% Confidence Interval|Number
26050|NCT01667471|Secondary|CRP Levels|CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL).|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mg/dL||Standard Deviation|Mean
26051|NCT01667471|Secondary|Parent or Participant's Assessment of Pain (VAS)|Parents or participants rated participant's pain by placing a horizontal line on a VAS of 0 (no pain)- 100 mm (severe pain).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm||Standard Deviation|Mean
26052|NCT01667471|Secondary|CHAQ-DI Score|The CHAQ-DI questionnaire consisted of 30 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain had at least two component questions and if applicable to the participant there were four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||score on a scale||Standard Deviation|Mean
26053|NCT01667471|Secondary|Erythrocyte Sedimentation Rate|ESR is a marker of inflammation and was measured as millimeters per hour (mm/h). Healthy individuals have low ESR. Higher ESR indicate inflammation.|Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm/h||Standard Deviation|Mean
26054|NCT01667471|Secondary|Number of Joints With Lack of Motion|Joints with lack of movement were assessed. The maximum number of joints with lack of movement was 67. The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant’s efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||joints||Standard Deviation|Mean
26055|NCT01667471|Secondary|Number of Joints With Active Arthritis|Joints with active arthritis were defined as joints with swelling or pain and limited of motion. The maximum number of joints with active arthritis was 71.The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant’s efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||joints||Standard Deviation|Mean
26056|NCT01667471|Secondary|Parent or Participant's Assessment of Global Activity (VAS)|The participant or parent/guardian, as appropriate, provided a rating of the participant’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line Score 0 represented ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end score 100 represented ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicated poorer well-being.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm||Standard Deviation|Mean
26057|NCT01667471|Secondary|Physicians Assessment of Global Activity (VAS)|The participant’s treating physician provided a rating of the participant’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line, score 0 represented ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end score 100 represented ‘arthritis very active’. A higher score indicated more disease activity.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.||mm||Standard Deviation|Mean
26058|NCT01667471|Secondary|Percentage of Participants Achieving Clinical Remission (CR) at Each Visit|"CR was defined as clinical remission with medication (CRem). A participant was in CR if inactive disease was observed for a minimum of 6 consecutive months."|Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
26059|NCT01667471|Secondary|Percentage of Participants With Inactive Disease by Visit|A participant was defined to show inactive disease if all of the following criteria were applied: 1) No joints with active arthritis (no joints with swelling and no joints with lack of motion), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) Physician's global assessment of disease activity equals (=) 0 millimeters (mm) on a Visual analog scale (VAS).|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
26060|NCT01667471|Primary|Number of AEs of Special Interest and Study Drug Related AEs|AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab.|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set||adverse events|||Number
26061|NCT01667471|Secondary|Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit|"The six JIA ACR components comprised of: 1) Physician's global assessment of disease activity, 2) Parent/Participant's global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP), and 6) Childhood Health Assessment Questionnaire - Disease Index (CHAQ-DI).~At an assessment visit, a JIA ACR30/50/70/90 response in comparison to Baseline was defined as: At least three of the six JIA ACR core components improving by at least 30 percent (%), 50%, 70%, or 90% respectively and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; number (n) = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
26101|NCT01666782|Secondary|The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.|Baseline and 28 days|||percentage of participants|||Number
28597|NCT01629134|Secondary|Swelling of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects’ lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
26062|NCT01667471|Primary|Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS).|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set||participants|||Number
26063|NCT01667432|Secondary|Safety: Incidence of Adverse Events||approximately 3 years||||||
26064|NCT01667432|Primary|In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive||approximately 3 years||||||
26065|NCT01667432|Secondary|Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio||approximately 3 years||||||
26066|NCT01667432|Secondary|Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years||||||
26067|NCT01667432|Secondary|Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years||||||
26068|NCT01667432|Secondary|HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative||approximately 3 years||||||
26069|NCT01667432|Secondary|Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.|At the end of treatment (Week 24)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.||percentage of participants||95% Confidence Interval|Number
26070|NCT01667432|Primary|Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml||approximately 3 years||||||
26071|NCT01667432|Primary|Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).|At the end of the study (Week 36)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.||Percentage of participants||95% Confidence Interval|Number
26072|NCT01667224|Secondary|Changes in Body Mss Index(BMI)|BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).|12 week|||kg/m2||Standard Error|Mean
26073|NCT01667224|Secondary|Changes in Body Weight.|Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|12 week|||kg||Standard Error|Mean
26074|NCT01667224|Secondary|Changes in Abdominal Total Fat Area.|Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).|12 week|||cm2||Standard Error|Mean
26075|NCT01667224|Primary|Changes in Body Fat Mass.|Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|12week|||kg||Standard Error|Mean
26076|NCT01667107|Secondary|Percentage of Participants Who Develop Invasive Fungal Infection|Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.|Up to Day 84|Participants were analyzed according to the group in which they were enrolled||Percentage of participants||95% Confidence Interval|Number
26077|NCT01667107|Primary|Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum|Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.|Up to Day 42|The population analyzed included all enrolled participants who had BAL and serum samples collected at the time of bronchoscopy and analyzed for posaconazole concentration. A participant could have more than 1 pair of samples (BAL and serum) included in the analysis.||mg/L|Participants|Standard Deviation|Mean
26078|NCT01667107|Post-Hoc|Time to Maximum Serum Concentration of Posaconazole (Tmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time required to achieve the maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants||Days||Standard Deviation|Mean
26079|NCT01667107|Post-Hoc|Maximum Serum Concentration of Posaconazole (Cmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants||mg/L||Standard Deviation|Mean
26080|NCT01667107|Post-Hoc|Time to Reach a Serum Concentration of Posaconazole of >=0.5 mg/L|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. A posaconazole concentration >=0.5 mg/L is the therapeutic level, the concentration thought to lead to antifungal efficacy. The time at which the serum posaconazole concentration reached >=0.5 mg/mL and remained at that level for all subsequent assessments was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants who reached and maintained posaconazole concentration of >=0.5 mg/L||Days||Standard Deviation|Mean
26102|NCT01666782|Secondary|The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.|28 days|||percentage of participants|||Number
26662|NCT01660022|Primary|OZ439 t1/2|OZ439 Elimination half-life|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||hour||Geometric Coefficient of Variation|Geometric Mean
26081|NCT01667107|Primary|Time to Reach 90% of the Steady State Serum Concentration of Posaconazole|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population to be analyzed included participants who complied with the protocol sufficiently to ensure that the results would exhibit the effects of treatment|||||
26082|NCT01666951|Other Pre-specified|Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.|The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.|30 days|||participants|||Number
26083|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||ratio||Standard Deviation|Mean
26084|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||ratio||Standard Deviation|Mean
26085|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||Percentage of fluctuation||Standard Deviation|Mean
26086|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||Percentage of fluctuation||Standard Deviation|Mean
26087|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||hour||Standard Deviation|Mean
26088|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||hour||Standard Deviation|Mean
26089|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||hour||Standard Deviation|Mean
26090|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng/mL||Standard Deviation|Mean
26091|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng/mL||Standard Deviation|Mean
26092|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng/mL||Standard Deviation|Mean
26093|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng*hr/mL||Standard Deviation|Mean
26094|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng*hr/mL||Standard Deviation|Mean
26095|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.||ng*hr/mL||Standard Deviation|Mean
26096|NCT01666951|Other Pre-specified|Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Day 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||mmHg||Standard Deviation|Mean
26097|NCT01666951|Other Pre-specified|Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.||mmHg||Standard Deviation|Mean
26103|NCT01666782|Primary|The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.|Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.|Baseline and 28 days|||titers||95% Confidence Interval|Geometric Mean
26104|NCT01666197|Primary|Pain on Movement|"Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|48 hours|||mm||Standard Deviation|Mean
26105|NCT01666002|Secondary|Proximal Clearance of Fungus on Nail|The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients’ toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.|1 year|||mm|Participants|Standard Deviation|Mean
26106|NCT01666002|Primary|The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.||1 year|||percentage of participants|||Number
26107|NCT01665911|Secondary|Enamel Fluoride Uptake Per Each of Five Arms|Enamel fluoride uptake is a measure of fluoridation of a caries lesion|Three Weeks per each of five arms|||microgram fluoride per square cm||Standard Error|Least Squares Mean
26108|NCT01665911|Secondary|% Acid Resistance Score Per Each of Five Arms|% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.|Three Weeks per each of five arms|||percent||Standard Error|Least Squares Mean
26109|NCT01665911|Primary|% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms|"surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:~SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening)."|Three Weeks per each of five arms|||percent||Standard Error|Least Squares Mean
26110|NCT01665807|Secondary|Pain at Injection Site|Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8)|Follow up (Day 8||||||
26111|NCT01665807|Secondary|Local & Systemic Reactogenicity|Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination|Follow up (Day 8)||||||
26112|NCT01665807|Secondary|Success Rate|Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.|Vaccination (Day 0)|||participants|||Number
26113|NCT01665807|Secondary|Acceptability of Vaccine|The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination.|Follow up (Day 8)||||||
26114|NCT01665807|Primary|Time to Administer Influenza Vaccine (in Seconds)|Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination|Vaccination (Day 0)|||seconds||Full Range|Median
26115|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Sitting - 7. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
26116|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Standing - 6. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
26117|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
26118|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Interview - 4. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
26119|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Preparation - 3. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
26120|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Standing - 2. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
26164|NCT01665053|Secondary|Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.|TVR overall includes: TVR PCI & TVR CABG.|12 months|Intent-to- Treat||percentage of participants|||Number
26121|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST|||(low frequency/high frequency)*10||Standard Deviation|Mean
26122|NCT01665170|Secondary|Norepinephrine (After)|2 min. after the TSST, higher value is better|1 day|||ng/dl||Standard Deviation|Mean
26123|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26124|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.~V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26125|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26126|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26127|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26128|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2, visite 3|||Percent Change||Standard Deviation|Mean
26165|NCT01665053|Secondary|Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.|The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG).|12 months|Intent-to-Treat population||percentage of participants|||Number
26129|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26130|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26131|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26132|NCT01665170|Primary|VAS Stress Perception (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3|||mm||Standard Deviation|Mean
26133|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.~V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)|||Percent Change||Standard Deviation|Mean
26134|NCT01665170|Secondary|MDBF Questionnaire|"The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = not at all to 5 = very true. To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3"|1 day||||||
26135|NCT01665170|Secondary|POMS Questionnaire|"The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = not at all to 7 = very strongly. The questionnaire is completed on V2 and V3."|1 day||||||
26136|NCT01665170|Secondary|State Anxiety (STAI-X1) Questionnaire|"The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = not at all to 4 = very true. The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3"|1 day||||||
26137|NCT01665170|Secondary|Norepinephrine (Before)|2 min. prior the TSST|before stress test|||ng/dl||Standard Deviation|Mean
26138|NCT01665170|Secondary|Epinephrine (Before)|2 min. prior the TSST|1 day||||||
26139|NCT01665170|Secondary|ACTH (Pre-post Comparison)|ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST|1 day||||||
26140|NCT01665170|Secondary|Serum Cortisol (Pre-post Comparison)|2 min. prior to and 1 min. after the TSST|1 day||||||
26166|NCT01665053|Primary|Percentage of Participants With Target Lesion Failure (TLF) at 12 Months|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|12 months|The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module.||percentage of participants|||Number
26167|NCT01664975|Secondary|Median Survival Time||24 months||12/2016||||
26141|NCT01665170|Primary|VAS Anxiety (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3|||mm||Standard Deviation|Mean
26142|NCT01665170|Primary|VAS Insecurity (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3|||mm||Standard Deviation|Mean
26143|NCT01665157|Primary|Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)|"Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of right segment preparation failure, defined as segmental score as 3 poor or 4 inadequate, was presented."|1 day|||percentage of participants|||Number
26144|NCT01665157|Secondary|Convenience of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who thinks the protocol is easy to use.|1 day|||percentage of participants|||Number
26145|NCT01665157|Secondary|Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who is satisfied with the protocol.|1 day|||Percentage of participants|||Number
26146|NCT01665157|Primary|Total Volume of Purgatives That Ingested|The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy|1 day|||Liter||Standard Deviation|Mean
26147|NCT01665157|Secondary|Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol|It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.|1 day|||percentage of participants|||Number
26148|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Aronchick Scale|"The overall proportion of participants scored as Excellent or Good by Aronchick scale.~Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present"|1 day|||percentage of participants|||Number
26149|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale|Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.|1 day|||units on a scale||Standard Deviation|Mean
26150|NCT01665053|Secondary|Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.|All CEC adjudicated revascularization at 12 month (Intent to treat population).|12 Month|Intent to treat population||percentage of patients|||Number
26151|NCT01665053|Secondary|Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.||12 month|Intent-to-Treat population||percentage of participants|||Number
26152|NCT01665053|Secondary|Periprocedural Clinical Procedural Success Rate|Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR.|Day 1 (periprocedure)|Intent-to-Treat population||percentage of lesions|||Number
26153|NCT01665053|Secondary|Periprocedural Technical Success Rate.|Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion.|Day 1 (periprocedure)|"Intent-to-Treat analysis set. Promus Element Plus population: 808 subject analyzed with 1043 stents used in total.~SYNERGY population: 832 subjects analyzed with 1059 stents used in total."||percentage of stents|||Number
26154|NCT01665053|Secondary|Percentage of Patients With a Stroke at 12 Month.|The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.|12 months|Intent-to-Treat population.||percentage of participants|||Number
26155|NCT01665053|Secondary|Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.||12 months|Intent-to-treat population.||percentage of participants|||Number
26156|NCT01665053|Secondary|Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
26157|NCT01665053|Secondary|Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
26158|NCT01665053|Secondary|Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
26159|NCT01665053|Secondary|Percentage of Patients That Died at 12 Months.|The Death rate includes Cardiac- & Non-Cardiac Death.|12 months|Intent-to-treat population||percentage of participants|||Number
26160|NCT01665053|Secondary|Percentage of Participants With Non-Cardiac Death at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
26161|NCT01665053|Secondary|Percentage of Participants With Cardiac Death at 12 Month.||12 months|Intent-to-treat population||percentage of participants|||Number
26162|NCT01665053|Secondary|Percentage of Participants With Myocardial Infarction at 12 Month.|The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.|12 months|Intent-to-treat||percentage of participants|||Number
26163|NCT01665053|Secondary|Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.|Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.|12 months|Intent-to-treat analysis||percentage of participants|||Number
26168|NCT01664975|Secondary|Overall Survival||up to the date of death (approximately 5 years)||09/2016||||
26171|NCT01664949|Secondary|Change From Baseline in the Schirmer Test|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||mm/5 minutes||Standard Deviation|Mean
26172|NCT01664949|Secondary|Change From Baseline in Conjunctival Staining|Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||score on a scale||Standard Deviation|Mean
26173|NCT01664949|Secondary|Change From Baseline in Corneal Staining|Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||score on a scale||Standard Deviation|Mean
26174|NCT01664949|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||seconds||Standard Deviation|Mean
26175|NCT01664949|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.||score on a scale||Standard Deviation|Mean
26176|NCT01664923|Secondary|Percentage of Participants With Adverse Event (AE)|"Assessment of adverse events was conducted from the date and time of the first dose of study drug through 30 days after the date of the last dose of study drug or before initiation of a cytotoxic or investigational therapy, whichever occurred first.~A serious adverse event was defined as any untoward medical occurrence that:~Resulted in death;~Was life threatening;~Required inpatient hospitalization or led to prolongation of hospitalization;~Resulted in persistent or significant disability or incapacity;~Resulted in a congenital anomaly or birth defect;~Was a medically important event.~An adverse event was considered related to the study drug if the event was assessed by the investigator as probably or possibly related."|From first dose of study drug up to 30 days after last dose of study drug. Median duration of the AE reporting period was 15.2 months in the enzalutamide arm and 9.4 months in the bicalutamide arm.|Safety population: All participants randomly assigned to study treatment who received at least 1 dose of study drug.||percentage of participants|||Number
26177|NCT01664923|Secondary|Best Overall Soft Tissue Response|Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.||percentage of participants||95% Confidence Interval|Number
26178|NCT01664923|Secondary|Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)|"The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life.~Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation."|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.||months||95% Confidence Interval|Median
26190|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of C-peptide|The concentration of C-peptide in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of C-peptide as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||ng/mL*hr||Standard Error|Least Squares Mean
26179|NCT01664923|Secondary|Duration of Radiographic PFS|Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants with metastatic disease at study entry and randomly assigned to study treatment.||months||95% Confidence Interval|Median
26180|NCT01664923|Secondary|Percentage of Participants With a PSA Response ≥ 50%|PSA response was defined as a reduction in PSA of at least 50% from baseline at any postbaseline assessment confirmed by a second PSA assessment at least 3 weeks later.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Evaluable intent-to-treat population: all participants randomly assigned to study treatment and had a baseline and at least 1 postbaseline PSA measurement.||percentage of participants||95% Confidence Interval|Number
26181|NCT01664923|Secondary|Time to PSA Progression|PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.||months||95% Confidence Interval|Median
26182|NCT01664923|Primary|Progression Free Survival (PFS)|PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.||months||95% Confidence Interval|Median
26183|NCT01664806|Secondary|Histologic Evidence of Burn at the Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day|A sample size of convenience for feasibility.||participants|||Number
26184|NCT01664806|Primary|Histologic Thermal Injury to Epigastric Port Site Skin|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.|1 day|A sample size of convenience for feasibility.||participants|||Number
26185|NCT01664793|Secondary|Effectiveness Score|Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).|End of February 2012|||units on a scale||Standard Deviation|Mean
26186|NCT01664793|Primary|Primary Outcome|Influenza vaccination rates in each arm at the end of year 1|3/1/2011-2/29/2012|||participants vaccinated out of all|||Number
26187|NCT01664624|Secondary|Change From Baseline to Day 11 in 24-hour Average Plasma Glucose|Plasma glucose was measured by Continuous Glucose Monitoring System (CGMS). CGMS measures glucose every 5 minutes, starting in the fasting state 8 hour prior to the standardized breakfast (12 AM) until 16 hours after the breakfast. The average 24-hour plasma glucose concentration was calculated. Least squares means were obtained using an ANCOVA model with treatment as fixed effect, and Baseline 24-hour Glucose Measured by CGMS as a continuous covariate.|Baseline (Day -1) and Day 11, from 12 AM through 24 hours.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||mg/dL||Standard Error|Least Squares Mean
26188|NCT01664624|Secondary|Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation|"Appetite sensations were measured using a visual analog scale (VAS) questionnaire. Participants were asked to indicate their level of fullness, hunger, satiety, and prospective consumption (how much do you think you can eat?) on a 100 mm line ranging from Not at all (0 mm) to extremely (100 mm). Appetite sensation scores before and up to 8 hours after eating were plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of appetite sensation VAS score as a continuous covariate."|At Baseline and Day 11, every 30 minutes, starting 1 hour before eating until 8 hour after the meal.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||mm*hr||Standard Error|Least Squares Mean
26189|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of Insulin|The concentration of insulin in blood before and up to 8 hours after eating was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of insulin as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||pmol/L*hr||Standard Error|Least Squares Mean
26191|NCT01664624|Secondary|Change From Baseline in AUC(0-8) of Postprandial Plasma Glucose|The concentration of glucose in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and baseline postprandial AUC (0-8) of plasma glucose as a continuous covariate.|Baseline and Day 11 at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.||mmol/L*hr||Standard Error|Least Squares Mean
26192|NCT01664624|Primary|Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1|The concentration of glucagon-like peptide-1 (GLP-1) in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an analysis of covariance (ANCOVA) model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of active GLP-1 as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set defined as all randomized participants included in the safety analysis. Only participants with data at both Baseline and post-baseline visits are included.||pmol/L*hr||Standard Error|Least Squares Mean
26193|NCT01664559|Secondary|Post-insertion Provider Questionnaire|"The provider will be asked to fill out a multiple choice format questionnaire:~what level training are you?~which IUD was inserted?~what was the purpose of IUD placement?~what was the position of the uterus?~did the IUD placement process require cervical dilation?~were you able to complete the IUD insertion?~was there bleeding from the cervix that required more than 5 min to control?~were there any major complications with the IUD insertion?~did the patient take tylenol prior to leaving the office?"|Immediately after IUD placement, on average within 1 hour|||participants|||Number
26194|NCT01664559|Secondary|Post-insertion Patient Questionnaire|"Questions assessed in multiple choice format:~Side effects~injection site pain~overall satisfaction with IUD insertion experience~would they still recommend IUD placement to a friend?~significant pain for which they desired acetaminophen prior to leaving the office?"|assessed at 15 minutes after IUD insertion|||participants|||Number
26195|NCT01664559|Secondary|Nulliparous Patients - Subgroup Analysis|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.~Prior to injection of study drug, anticipated pain~Pain from study drug injection, measured immediately after injection~Pain from speculum insertion, measured immediately after insertion~Pain with tenaculum placement, measured immediately after placement~Pain with uterine sounding, measured immediately after removal of the sound~Pain at 5 minutes after placement of the intrauterine device~Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)|||cm||Inter-Quartile Range|Median
26196|NCT01664559|Secondary|Pain Scores at Other Time Points During and After IUD Placement|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.~Prior to injection of study drug, anticipated pain~Pain from study drug injection, measured immediately after injection~Pain from speculum insertion, measured immediately after insertion~Pain with tenaculum placement, measured immediately after placement~Pain with uterine sounding, measured immediately after removal of the sound~Pain at 5 minutes after placement of the intrauterine device~Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)|||cm||Inter-Quartile Range|Median
26197|NCT01664559|Primary|VAS (Visual Analogue Scale) Measurement of Pain|The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.|Pain with IUD placement, measured immediately after placement|||units on a scale||Inter-Quartile Range|Median
26198|NCT01664533|Secondary|Percentage of Participants Who Developed Diarrhea||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.||percentage of participants||95% Confidence Interval|Number
26199|NCT01664533|Secondary|Percentage of Participants Who Developed Rash||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.||percentage of participants||95% Confidence Interval|Number
26200|NCT01664533|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until death from any cause.|Up to 2 years|||months||95% Confidence Interval|Median
26201|NCT01664533|Secondary|Best Overall Response|Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Percentage of participants||97.5% Confidence Interval|Number
26202|NCT01664533|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.||Months||95% Confidence Interval|Median
28309|NCT01634243|Secondary|Off Time for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing|Subjects with measurable off time data at baseline and after dosing, LOCF||Hours||Standard Deviation|Mean
26203|NCT01664494|Secondary|Median Dose of Capecitabine|Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.||Milligrams||Full Range|Median
26204|NCT01664494|Primary|Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment|Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.||Participants|||Number
26205|NCT01664247|Secondary|Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)|Change in subject’s quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 3 subjects PRO scores were missing at the baseline and did not contribute to the analysis.||T-scores||Standard Deviation|Mean
26206|NCT01664247|Secondary|Number of Adverse Events|Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0 - 26|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
26207|NCT01664247|Secondary|Number of Hypoglycaemic Episodes|Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.|Weeks 0 - 26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
26208|NCT01664247|Secondary|Change From Baseline in Mean of the 8-point Profile|Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects and missing data is imputed using LOCF. Mean values were missing for 11 subjects.||mmol/L||Standard Deviation|Mean
26209|NCT01664247|Secondary|Change From Baseline in 8-point Profile|The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects. The subjects not analysed were 12, 45, 46, 44, 44, 54, 56 and 21 subjects for before breakfast, 90 mins after breakfast, before lunch, 90 mins after start of lunch, before main evening meal, 90 mins after main evening meal, before bedtime and before breakfast the following day time points respectively.||mmol/L||Standard Error|Least Squares Mean
26210|NCT01664247|Secondary|Change From Baseline in Mean Pre-breakfast Measurements Used for Titration|Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects the baseline values were missing||mmol/L||Standard Error|Least Squares Mean
26211|NCT01664247|Secondary|Number of Responders for HbA1c (Below 7.0 %)|Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.|After 26 weeks of randomised treatment.|The FAS included all randomised subjects and missing data was imputed using LOCF.||percentage (%) of subjects|||Number
26212|NCT01664247|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects FPG values were missing.||mmol/L||Standard Deviation|Mean
26213|NCT01664247|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
26214|NCT01664117|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|At the time of change of treatment (to the current treatment)|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26215|NCT01664117|Secondary|Number of Participants With Adverse Events Leading to a Change of Treatment|An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.|At the time of change of treatment|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26216|NCT01664117|Secondary|Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26217|NCT01664117|Secondary|Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Number of joints||Standard Deviation|Mean
26218|NCT01664117|Secondary|Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score|Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26219|NCT01664117|Secondary|Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study|Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
26220|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||Number of sDMARD/bDMARDs/Other||Standard Deviation|Mean
26221|NCT01664117|Secondary|Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||years||Standard Deviation|Mean
26222|NCT01664117|Secondary|Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study|Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26223|NCT01664117|Secondary|Number of Participants With Reasons for Starting Current Biologic Monotherapy|The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26224|NCT01664117|Secondary|Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy|Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26225|NCT01664117|Secondary|Number of Participants Received Current bDMARD Treatment at the Time of the Study|Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26226|NCT01664117|Secondary|Number of Participants Treated With Concomitant Medications Before the Study|Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26227|NCT01664117|Secondary|Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment|Median time in months taking the Biologic Agent in monotherapy before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||Months||Full Range|Median
26228|NCT01664117|Secondary|Number of Participants Discontinued the Previous Treatment and Started the Study Treatment|The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26229|NCT01664117|Secondary|Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26230|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)|Number of sDMARD and bDMARDs received by Participants before the study was presented|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.||Number of sDMARD/bDMARD||Standard Deviation|Mean
26231|NCT01664117|Secondary|Number of Participants With Changing the Previous sDMARD/ bDMARD|Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ represents the number of participants analyzed at a specified time point.||Participants|||Number
26232|NCT01664117|Secondary|Mean Time Between the Last sDMARD and bDMARD Received at Visit 1|Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.|At Visit 1|Analysis Population included all enrolled participants who met the inclusion criteria. ‘n' signifies the number of participants analyzed at specified time point.||Months||Standard Deviation|Mean
26233|NCT01664117|Secondary|Number of Participants Who Received Each bDMARD Before the Study|Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26234|NCT01664117|Secondary|Number of Participants Prescribed First bDMARD Before the Study|Number of participants prescribed first bDMARD before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Participants|||Number
26922|NCT01656161|Secondary|Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169||on Days 1 and 169|Intention to treat (ITT) population with a measured value at the time analysed||percentage of participants||95% Confidence Interval|Number
26235|NCT01664117|Secondary|Number of Participants Who Received Last sDMARD Prescribed Before the Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||participants|||Number
26236|NCT01664117|Secondary|Number of Participants Who Received Each sDMARD Before The Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Participants|||Number
26237|NCT01664117|Secondary|Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug|Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ = number of participants prescribed with first sDMARD or bDMARD.||Months||Standard Deviation|Mean
26238|NCT01664117|Secondary|Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study|Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.||Participants|||Number
26239|NCT01664117|Primary|Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1|SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26240|NCT01664117|Primary|Mean Score on Simple Disease Activity Index at Visit 1|Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Scores on a scale||Standard Deviation|Mean
26241|NCT01664117|Primary|Number of Participants With Clinical Disease Activity by Categorization at Visit 1|CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26242|NCT01664117|Primary|Mean Score on Clinical Disease Activity Index at Visit 1|Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Scores on a scale||Standard Deviation|Mean
26243|NCT01664117|Primary|Number of Participants With Disease Activity Score by Categorization at Visit 1|DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high >5.1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26244|NCT01664117|Primary|Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1|Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
26245|NCT01664117|Primary|Number of Participants With Joint Damage at Visit 1|Number of participants with joint damage is recorded as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26246|NCT01664117|Primary|Patient Pain Visual Analog Scale Score at Visit 1|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain"|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. Out of 209 participants, 207 were analysed for patient pain visual analog scale.||Units on a scale||Standard Deviation|Mean
26247|NCT01664117|Primary|Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1|The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26248|NCT01664117|Primary|Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies|Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants||Participants|||Number
26249|NCT01664117|Primary|Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1|Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' =number of evaluated participants||Participants|||Number
26250|NCT01664117|Primary|Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1|Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants||Participants|||Number
26251|NCT01664117|Primary|Patient’s Global Assessment of Disease Activity at Visit 1|Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
26252|NCT01664117|Primary|Physician’s Global Assessment of Disease Activity at Visit 1|The Physician’s global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Units on a scale||Standard Deviation|Mean
26253|NCT01664117|Primary|Mean Number of Painful and Swollen Joints at Visit 1|Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Number of joints||Standard Deviation|Mean
26254|NCT01664117|Primary|Number of Participants With Extra-articular Manifestations at Visit 1|Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty’s syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26255|NCT01664117|Primary|Number of Participants With Co-morbidities|Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26256|NCT01664117|Primary|Number of Participants With Family History of Rheumatoid Arthritis|Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26257|NCT01664117|Primary|Mean Time of Onset of Rheumatoid Arthritis|Onset of rheumatoid arthritis is a component of clinical characteristics.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Years||Standard Deviation|Mean
26258|NCT01664117|Primary|Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )|Smoking-habit included years of smoking/quit smoking is reported for participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' = number of evaluated participants||Years||Standard Deviation|Mean
26259|NCT01664117|Primary|Smoking-habit for Smokers or Ex-smokers (Packs in Years)|Smoking-habit included number of pack per years is reported.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n = number of evaluated participants||Years||Standard Deviation|Mean
26260|NCT01664117|Primary|Number of Participants With Smoking Habits|Smoking habits is a component of socio-demographic characteristics. Participants’ smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.||Participants|||Number
26261|NCT01664117|Primary|Number of Participants With Level of Education Completed|Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)|At Visit 1 (Single visit study)|Analysis population included all enrolled participants who met the screening criteria||Participants|||Number
26262|NCT01664052|Primary|Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|90 days after insert placement|||Occluded fallopian tubes|Participants||Number
26263|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|60 days after insert placement|||Occluded fallopian tubes|Participants||Number
26923|NCT01656161|Primary|Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)||within 337 days|Intention to treat population||Percentage of Participants||95% Confidence Interval|Number
26264|NCT01664052|Primary|Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|30 days after insert placement|||Occluded fallopian tubes|Participants||Number
26265|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.|60 minutes after insert placement|||Occluded fallopian tubes|Participants||Number
26266|NCT01664039|Secondary|Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6|TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||seconds||Standard Deviation|Mean
26267|NCT01664039|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6|"The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health."|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
26268|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6|Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.||participants|||Number
26269|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6|Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.||participants|||Number
26270|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit|Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.||participants|||Number
26271|NCT01664039|Secondary|Percentage of Subjects Who Reached Target IOP at Each Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Week 6, Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||percentage of participants|||Number
26272|NCT01664039|Secondary|Mean Change From Baseline in IOP at Week 6 and Month 3|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||mmHg||Standard Deviation|Mean
26273|NCT01664039|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."||mmHg||Standard Deviation|Mean
26362|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)|The number of participants who achieved successful treatment response in msDBP of < 90mmHg or a reduction ≥ 10mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as having a successful response.|8 weeks of treatment|FAS||Participants|||Number
26274|NCT01663987|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Time to event: Time to recovery (EXACT-PRO) was not analysed, only Kaplan meier curve was plotted. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2 and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years||||||
26275|NCT01663987|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||Hospitalisation per patient year|||Number
26276|NCT01663987|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||exacerbations per patient year|||Number
26277|NCT01663987|Secondary|Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with 30-day hospital readmission rates outcome events was analysed.~Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.~The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|from date of hospital discharge prior to randomization up to readmission days >1 and <31 days|Treated set of the pooled twin studies 205.478 and 205.477||Percentage of participants|||Number
26278|NCT01663987|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.~All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures. Hospitalizations occurring on the same day as discharge were not considered a separate admission.~This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||Percentage of participants|||Number
26279|NCT01663987|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with COPD exacerbation on study was analysed for the combined study.~A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following: 1) Shortness of breath; 2) Sputum production (volume); 3)Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness. Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.~A required change in treatment included either prescription of antibiotics and/or systemic steroids; and a newly prescribed maintenance respiratory medication (i.e. bronchodilators including theophyllines and PDE4-inhibitors).~This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477||Percentage of participants|||Number
26280|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.~This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated set of the pooled twin studies 205.478 and 205.477||Litres||Standard Deviation|Mean
26281|NCT01663987|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of Trough FEV1 (forced expiratory volume in one second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.~This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated set of the pooled twin studies 205.478 and 205.477||Litres||Standard Deviation|Mean
26282|NCT01663987|Secondary|Percentage of Patients With Adverse Clinical Event on Study|Percentage of patients with adverse clinical event during on study, which is defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalisation, or all cause mortality.|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set||Percentage of participants|||Number
26283|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FVC data at both baseline and week 12||Litres||Standard Deviation|Mean
26363|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)|The number of participants who achieved successful treatment response in the msSBP of < 140mmHg or a reduction ≥ 20 mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as a having a successful response.|8 weeks|FAS||Participants|||Number
26284|NCT01663987|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.~Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477: This set includes all patients who were randomised and took at least one dose of study drug, 157 patients (79 Tiotropium and 78 placebo) were included in this set.||Percentage of perticipants|||Number
26285|NCT01663987|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug|Change from baseline in trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FEV1 data at both baseline and week 12||Litres||Standard Deviation|Mean
26286|NCT01663922|Primary|Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort)|"Pharmacokinetic parameters (maximum and trough concentrations, and area under concentratof boceprevir and SJW will be evaluated when given in combination at steady-state to evaluate possible differences in concentrations during co-administration versus drug given alone.~The pharmacokinetic parameters calculated for boceprevir and SJW will be Ctrough,the maximum observed plasma concentration (Cmax), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve.~All pharmacokinetic parameters will be calculated using non-compartmental modelling techniques (WinNonlin®) and all statistical calculations performed within-participant changes in the assessed pharmacokinetic parameters (drug alone vs drug combination) will be evaluated by calculating geometric mean ratios."|6 months|All participants who completed the three PK assessments were included in the analysis. BCP metabolites (SCH534128 & SCH523129) PK parameters were determined in the presence and absence of SJW, and hypericin PK parameters in the presence and absence of BCP; for the total study population.||ng*h/mL||90% Confidence Interval|Geometric Mean
26287|NCT01663779|Primary|First Pass Success When Attempting Arterial Catheterization.|first pass success when attempting arterial catheterization of the artery|Immediate, upon study entry|||participants|||Number
26288|NCT01663727|Secondary|Percentage of Participants Who Were Alive at 1 Year||1 year||||||
26289|NCT01663727|Secondary|Duration of Response - High Baseline Plasma VEGF-A ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.||months||95% Confidence Interval|Median
26290|NCT01663727|Secondary|Duration of Response - ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population who had an objective response.||months||95% Confidence Interval|Median
26291|NCT01663727|Secondary|Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
26292|NCT01663727|Primary|PFS in High Baseline Plasma VEGF-A ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population.||months||95% Confidence Interval|Median
26293|NCT01663727|Primary|Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population|Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.||percentage of participants|||Number
26294|NCT01663727|Secondary|Percentage of Participants With an Objective Response - ITT Population|Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
26295|NCT01663727|Secondary|OS - High Baseline Plasma VEGF-A ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 90.9 weeks)|High Baseline Plasma VEGF-A ITT population.||months||95% Confidence Interval|Median
26296|NCT01663727|Secondary|Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population||From randomization till death or clinical cut-off (up to 90.9 weeks)|High Baseline Plasma VEGF-A ITT Population.||percentage of participants|||Number
26297|NCT01663727|Secondary|Overall Survival (OS) - ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 111.7 weeks)|ITT population.||months||95% Confidence Interval|Median
26298|NCT01663727|Secondary|Percentage of Participants Who Died - ITT Population||From randomization till death or clinical cut-off (up to 111.7 weeks)|ITT Population.||percentage of participants|||Number
26299|NCT01663727|Primary|Progression Free Survival (PFS) in ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.||months||95% Confidence Interval|Median
26300|NCT01663727|Primary|Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population|Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.||percentage of participants|||Number
26301|NCT01663714|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||months||95% Confidence Interval|Median
26302|NCT01663714|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be positive, a participant had to have a positive HAMA assessment during the first 24 months."|Day 1 to Day 730 (24 months) after receiving the dosimetric dose|ITT Exposed Population||participants|||Number
26303|NCT01663714|Secondary|Number of Participants Who Received Any Supportive Care|Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population||participants|||Number
26304|NCT01663714|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. All participants who died during the study were analyzed.||participants|||Number
26315|NCT01663714|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis.||months||95% Confidence Interval|Median
28598|NCT01629134|Secondary|Bruising of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects’ lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
26305|NCT01663714|Secondary|Number of Participants With Any Treatment-related Serious Adverse Event (SAE)|An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed.||participants|||Number
26306|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
26307|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
26308|NCT01663714|Secondary|Nadir Values for WBC Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||10^3 cells/µL||Full Range|Median
26309|NCT01663714|Secondary|Nadir Values for Platelet Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||10^3 cells/microliter (µL)||Full Range|Median
26310|NCT01663714|Secondary|Nadir Values for Hemoglobin|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||Grams/deciliter (g/dL)||Full Range|Median
26311|NCT01663714|Secondary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||10^3 cells/cubic millimeters (mm^3)||Full Range|Median
26312|NCT01663714|Secondary|Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations|TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline.||days||95% Confidence Interval|Median
26313|NCT01663714|Secondary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population||days||Full Range|Median
26314|NCT01663714|Secondary|Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD|To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.|Day (D) 0; D 2, 3, or 4; and D 6 or 7|ITT Exposed Population||hours||Standard Deviation|Mean
26663|NCT01660022|Primary|OZ439 AUC(0-168)|Area under the plasma concentration versus time curve to 168 hours post-dose.|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
26316|NCT01663714|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis.||months||95% Confidence Interval|Median
26317|NCT01663714|Secondary|DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.||months||95% Confidence Interval|Median
26318|NCT01663714|Secondary|Duration of Response (DOR), as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.||months||95% Confidence Interval|Median
26319|NCT01663714|Secondary|Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
26320|NCT01663714|Secondary|Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population||participants|||Number
26321|NCT01663714|Primary|Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.||participants|||Number
26322|NCT01663714|Primary|Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.||participants|||Number
26323|NCT01663532|Secondary|Responder Rate Based on PANSS Total Score.|Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.||participants|||Number
26324|NCT01663532|Secondary|Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.||Units on a scale||Standard Deviation|Mean
26325|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.|The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Week 10|Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.||Units on a scale||Standard Error|Least Squares Mean
26326|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
26327|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
26328|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
26329|NCT01663532|Primary|Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.||Units on a scale||Standard Error|Least Squares Mean
26330|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on CDAI Score|Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score <= 2.8; low disease activity: CDAI <=10.0; moderate disease activity: CDAI <=22.0; and high disease activity: CDAI >22.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
26344|NCT01663506|Secondary|Visual Analog Scale (VAS)-Pain|Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
26331|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on SDAI Score|Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score <= 3.3; low disease activity: SDAI <=11.0; moderate disease activity: SDAI <=26.0; and high disease activity: SDAI >26.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
26332|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on DAS28 Score|Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score <= 2.6; low disease activity: DAS28 <=3.2; moderate disease activity: DAS28 <=5.1; and high disease activity: DAS28 >5.1.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
26333|NCT01663506|Secondary|Number of Participants Receiving Oral Corticosteroids||Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||participants|||Number
26334|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.||participants|||Number
26335|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab as Monotherapy||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.||participants|||Number
26336|NCT01663506|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
26337|NCT01663506|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
26338|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 28 Joints|Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.||joints count||Standard Deviation|Mean
26339|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 66 and 68 Joints|Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.||joints count||Standard Deviation|Mean
26340|NCT01663506|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mg/L||Standard Deviation|Mean
26341|NCT01663506|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm/hr||Standard Deviation|Mean
26342|NCT01663506|Secondary|Visual Analog Scale-Morning Stiffness (VAS-MS)|Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
26343|NCT01663506|Secondary|Visual Analog Fatigue Scale (VAFS)|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
26664|NCT01660022|Primary|Piperaquine Cmax|Piperaquine Maximum concentration level|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
26345|NCT01663506|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
26346|NCT01663506|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
26347|NCT01663506|Secondary|Physician Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||mm||Standard Deviation|Mean
26348|NCT01663506|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline >1.2 with DAS28 <= 3.2; moderate responders: decrease from baseline >1.2 with DAS28 >3.2 or decrease from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: decrease from baseline <= 0.6 or decrease from baseline >0.6 and <=1.2 with DAS28 >5.1.|Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.||participants|||Number
26349|NCT01663506|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (<=) 2.6 meant clinical remission; DAS28 <=3.2 meant low disease activity; DAS28 greater than (>) 3.2 to 5.1 implied moderate disease activity; and DAS28 >5.1 implied high disease activity.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||units on a scale||Standard Deviation|Mean
26350|NCT01663506|Secondary|Number of Participants With Prior Exposure of Biologics||Baseline|FAS.||participants|||Number
26351|NCT01663506|Secondary|Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline|FAS.||participants|||Number
26352|NCT01663506|Secondary|Number of Participants With Comorbidities at Baseline|Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.|Baseline|FAS.||participants|||Number
26353|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity|Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (>=) 75 days between two consecutive doses of study drug.|Up to Month 12|FAS.||percentage of participants|||Number
26354|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation||Month 12|FAS.||percentage of participants||95% Confidence Interval|Number
26355|NCT01663506|Primary|Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation||6 Months|FAS.||percentage of participants||95% Confidence Interval|Number
26356|NCT01663363|Secondary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||6 Months|Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure “Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better“.||percentage of eyes|Participants|95% Confidence Interval|Number
26357|NCT01663363|Primary|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|"Data from 334 eyes of 170 participants are included for the outcome measure Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)."||percentage of eyes|Participants|95% Confidence Interval|Number
26358|NCT01663285|Secondary|Number of Participants With Adverse Events|The safety of neoadjuvant chemotherapy.|9 years|Due to poor patient enrollment this outcome was not able to be analyzed.|||||
26359|NCT01663285|Secondary|Number of Patients With Pathologic T0/Tis/Ta N0.|The proportion of patients with pathologic T0/Tis/Ta N0.|51 months|Due to poor patient enrollment this outcome was not able to be analyzed.|||||
26360|NCT01663285|Primary|Recurrence-free Survival Time|The 2-year recurrence-free survival (RFS) time for patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma.|2 years after participant surgery|Due to poor patient enrollment the primary objective was not able to be analyzed.|||||
26361|NCT01663233|Secondary|Number of Participants With Adverse Event|Participants were monitored for adverse events, serious adverse events and death.|8 weeks|Safety Set: The safety set included all randomized participants who received at least one dose of study medication.||Participants|||Number
26364|NCT01663233|Secondary|Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)|The number of participants achieving a systolic and diastolic blood pressure < 140/90 mmHg was measured. This outcome measure shows how well a given blood pressure treatment can achieve a given blood pressure target or goal. Participants who achieved the target blood pressure were determined based on the mean SBP and DBP measurements taken at the end of the study. If the participants' BP measurement was below the above target, they were considered to have successful blood pressure control.|8 weeks|FAS||Participants|||Number
26365|NCT01663233|Secondary|Change in Sitting Pulse Pressure (PP)|The change in the patient's mean sitting PP from baseline to end of the study was measured. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
26366|NCT01663233|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The change in the patient's msDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
26367|NCT01663233|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|The change in the patient's msSBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
26368|NCT01663233|Secondary|Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)|The change in mean 24 hour maDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.||mmHg||Standard Error|Least Squares Mean
26369|NCT01663233|Primary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)|The change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups was measured. A greater reduction from baseline in the LCZ696 group indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.||mmHg||Standard Error|Least Squares Mean
26370|NCT01663103|Other Pre-specified|Change in Vascular Endothelial NADPH Oxidase Expression|Vascular endothelial cells will be collected and assessed for changes in protein expression of NADPH oxidase after 3 months of treatment with rilonacept vs. placebo. Protein expression is calculated as a ratio of intensity of staining in the patient cells relative to human umbilical vein endothelial cell (HUVEC) control cells. The absolute change in this ratio between baseline and week 12 is reported below.|3 months after start of treatment|sub-group from Denver site||absolute change in ratio||Standard Deviation|Mean
26371|NCT01663103|Other Pre-specified|Change in High-sensitivity C-reactive Protein (hsCRP)|Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation.|3 months after start of treatment|||change in c-reactive protein (mg/L)||Inter-Quartile Range|Median
26372|NCT01663103|Secondary|Change in Contribution of Oxidative Stress to FMD|FMD will be assessed following acute infusion of ascorbic acid compared to saline. The improvement in FMD with ascorbic acid reflects the degree of oxidative stress contributing to impairment in FMD.|3 months after start of treatment|sub-group from Denver site||change in percent flow-mediated dilation||Standard Deviation|Mean
26373|NCT01663103|Secondary|Change in Aortic Pulse-wave Velocity (aPWV)|Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment|||change in pulse-wave velocity (cm/sec)||Standard Deviation|Mean
26374|NCT01663103|Primary|Change in Flow-mediated Dilation (FMD)|Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment|||change in percent flow-mediated dilation||Standard Deviation|Mean
26375|NCT01663012|Secondary|Overall Survival From Time of Diagnosis|Will be described using Kaplan-Meier estimates.|From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years.|||Months||95% Confidence Interval|Median
26376|NCT01663012|Secondary|Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death|Will be described using Kaplan-Meier estimates.|From date of first dose of NKTR-102 to date of death, assessed up to 2 years|||Months||95% Confidence Interval|Median
26377|NCT01663012|Primary|Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria|Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability).|6 weeks from first administration of NKTR-102|||participants|||Number
26378|NCT01662999|Secondary|Number of Participants With Change From Baseline in ECG Interval - Safety Population|A 12-Lead electrocardiogram (ECG) was performed and recorded after the participant had been supine for at least 5 minutes. ECGs done at baseline (Day-1 of Period 1) and at end of study; therefore the results are presented by sequence, and cannot be presented by treatment. QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). Abnormality criteria: QT/QTcF QT or QTcF >450 msec and <=480 msec at any postdose time point and not present at baseline. QT or QTcF >480 msec and <=500 msec at any postdose time point and not present at baseline QT or QTcF >500 msec at any postdose time point and not present at baseline. QT/QTcF Increase from baseline >60 msec for at least 1 postdose measurement. Increase from baseline in QT or QTcF >30 msec for at least 1 postdose measurement, but <=60 msec for all postdose measurements.|Baseline to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
26665|NCT01660022|Primary|OZ439 Cmax|OZ439 Maximum concentration level|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
26379|NCT01662999|Secondary|Number of Participants With Marked Urinalysis Laboratory Abnormalities - Safety Population|Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Fasted for 10 hours prior to samples taken. LLN=lower limit of normal; ULN=upper limit of normal; pretreatment (Pre-Rx). Normals: Urine glucose qualitative: dipstick >=1 if Pre-Rx <1 or 2*Pre-Rx if Pre-Rx>=1; urine microscopic white blood cell count (WBC): >=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2;urine red blood cell count (RBC):>=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug. Urine WBC and RBC were not done for all 42 participants. Number of participants analyzed (N) for the 3 treatments for WBC/RBC urine were 4, 8, 6, in treatment A, B, C, respectively.||participants|||Number
26380|NCT01662999|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal(LLN); upper limit of normal (ULN); pre-treatment(Pre-Rx). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-Rx >ULN or >1.25*ULN if Pre-Rx <=ULN; aspartate aminotransferase (AST) U/L: >1.25*Pre-Rx if Pre-Rx > ULN or 1.25*ULN if Pre-Rx <= ULN;alanine aminotransferase (ALT) U/L: >1.25*Pre-Rx if Pre-Rx>ULN or 1.25*ULN if Pre-Rx<=ULN;blood urea nitrogen (BUN)mmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.2*Pre-Rx if Pre-Rx >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.25*Pre-Rx if Pre-Rx >ULN;direct bilirubin µmol/L: >1.1*ULN if Pre-Rx <= ULN or >1.25*Pre-Rx if Pre-Rx > ULN; creatine phosphokinase (CK) U/L: >1.5*Pre-Rx if Pre-Rx >ULN or >1.5*ULN if Pre-Rx <= ULN.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
26381|NCT01662999|Secondary|Mean Change From Baseline in Temperature - Safety Population|Participant had their temperature taken after quietly sitting for at least 5 minutes and it was measured as degrees of centigrade (C). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.||degrees of centigrade||Standard Deviation|Mean
26382|NCT01662999|Secondary|Mean Change From Baseline in Respiration Rate - Safety Population|Respiration rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in breaths per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|||bpm||Standard Deviation|Mean
26383|NCT01662999|Secondary|Mean Change From Baseline in Heart Rate - Safety Population|Heart rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in beats per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.||bpm||Standard Deviation|Mean
26384|NCT01662999|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure - Safety Population|Blood pressure was taken while the participant was quietly seated for at least 5 minutes. Blood pressure was measured in millimeters of mercury (mmHg). Baseline was Day -1 in Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.||mmHg||Standard Deviation|Mean
26385|NCT01662999|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal (LLN); upper limit of normal (ULN); pretreatment(pre-RX); treatment (RX). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (vol): <0.85*pre-RX; erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN; neutrophils+bands (*10^9 c/L): <0.85*Pre-RX if Pre-RX <1.5 or <1.5 if Pre-RX >=1.5; eosinophils (*10^9 c/L): if value >0.75; basophils (*10^9 c/L): if value >0.4; monocytes (*10^9c/L): if value >2; lymphocytes (*10^9 c/L): if value <0.750 or if value >7.50.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
26386|NCT01662999|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, or Discontinuations Due to Adverse Events - Safety Population|Adverse event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. End of study was approximately 16 days and was the time for a participant to conclude each of the 3 periods (including the 6 day washout between periods).|Day 1 to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.||participants|||Number
26387|NCT01662999|Secondary|Metabolite to Parent Molar Ratios (MR) of Cmax, AUC(INF), and AUC(0-T) of 5-OH Saxagliptin and Saxagliptin From a Single Dose 5 mg Saxagliptin Versus MR of Saxagliptin and 5-OH When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Saxagliptin is the parent drug and 5-OH saxagliptin is the metabolite. The molecular weights to be used for the molar ratios were 315.42 and 331.42 for saxagliptin and 5-OH, respectively. Plasma samples were analyzed for saxagliptin and for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL and 0.200 ng/mL to 100.0 ng/mL for saxagliptin and 5-OH, respectively).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||Molar ratio||Geometric Coefficient of Variation|Geometric Mean
26408|NCT01662986|Secondary|Exposure of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of COPD was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.||Patient years|||Number
26388|NCT01662999|Secondary|Half-life (T-HALF) of Saxagliptin, and 5-OH Saxagliptin From Single Dose 5 mg Saxagliptin Versus T-HALF of Saxagliptin and 5-OH From Co-administered Saxagliptin With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours (h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||h||Standard Deviation|Mean
26389|NCT01662999|Secondary|Tmax of Saxagliptin, 5-OH Saxagliptin, Saxagliptin Total Active Moiety From a Single Dose of Saxagliptin Versus Tmax of Saxagliptin, 5-OH, Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin and 5-OH by LC-MS/MS using a validated method. Tmax was derived from the plasma concentration versus time profile for study drug and was measured in hours (h). Saxagliptin was the drug, 5-OH saxagliptin was the metabolite, and Saxagliptin total Active Moiety was molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||h||Full Range|Median
26390|NCT01662999|Secondary|AUC(INF) and AUC(0-T) of the Saxagliptin Total Active Moiety From a Single Dose 5 mg Saxagliptin Versus AUC(INF) and AUC(0-T) of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. AUC(INF) is area under the plasma concentration-time curve from time zero extrapolated to infinity; AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) and both were derived from the plasma concentration versus time profile using a validated PK analysis program ™. Total moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin), AUC(0-T)and AUC(INF) were measured in nano Molars*hours (nM*h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||nM*h||Geometric Coefficient of Variation|Geometric Mean
26391|NCT01662999|Secondary|Cmax of the Saxagliptin Total Active Moiety From a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Cmax of saxagliptin total active moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin) was derived from the plasma concentration versus time profile for the saxagliptin total active moiety. Measurement was in nano Molars (nM).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||nM||Geometric Coefficient of Variation|Geometric Mean
26392|NCT01662999|Secondary|AUC(INF) of 5-OH Saxagliptin From a Single Dose Saxagliptin Versus AUC(INF) of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
26393|NCT01662999|Secondary|AUC(0-T) of 5-OH Saxagliptin From Single Dose Saxagliptin Versus AUC(0-T) of 5-OH From Saxagliptin Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method)and was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™. AUC (0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
26394|NCT01662999|Primary|AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
27283|NCT01648582|Secondary|Change in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||kilogram/square meter (kg/m2)||Standard Error|Least Squares Mean
26395|NCT01662999|Primary|AUC(0-T) of Saxagliptin From Single Dose 5 mg Saxagliptin Versus AUC(0-T) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography–Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(0-T), the area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
26396|NCT01662999|Secondary|Cmax of 5-Hydroxy (5-OH) Saxagliptin From a Single Dose Saxagliptin Versus Cmax of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). Actual sampling times were used for PK calculations. Cmax for 5-OH Saxagliptin (the major active metabolite of Saxagliptin) was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in ng/mL.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
26397|NCT01662999|Secondary|Plasma Apparent Clearance (CLT/F) of a Single Dose of Dapagliflozin Versus CLT/F of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. CLT/F was calculated as Dose/AUC(INF)and was measured in milliliters per minute (mL/min).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||mL/min||Geometric Coefficient of Variation|Geometric Mean
26398|NCT01662999|Primary|Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography–Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). Cmax for Saxagliptin was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in nanograms per milliliter (ng/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
26399|NCT01662999|Secondary|Half-life (T-HALF) of Dapagliflozin From a Single Dose of Dapagliflozin Versus T-Half of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.||hours||Standard Deviation|Mean
26400|NCT01662999|Primary|Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus AUC(0-T) for Dapagliflozin When Co-administered With 5 mg Saxagliptin|AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method). Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(0-T) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
26409|NCT01662986|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.||exacerbations per patient year|||Number
31579|NCT01579006|Secondary|Time to Restoration of Initial Dosing Regimen||6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
26401|NCT01662999|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus Tmax of Dapagliflozin When Co-administered With 5 mg Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. Tmax was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.||hours||Full Range|Median
26402|NCT01662999|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|AUC(INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. Serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(INF) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
26403|NCT01662999|Primary|Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population|The geometric mean of the maximum observed plasma concentration (Cmax) is presented below; serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h,and 60 h postdose, relative to dosing on Day 1 in each cross over period and these data are summarized in the Pharmacokinetic (PK) parameter of Cmax presented here. Plasma samples were analyzed for dapagliflozin by High Performance Liquid chromatography–Mass Spectrometry (HPLC-MS/MS) using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Dapagliflozin Cmax was derived from plasma concentration versus time data using a non-compartmental method, using a validated PK analysis program ™. Actual sampling times were used for PK calculations. Cmax was reported in ng/mL.|Day 1 (0 h to 60 h post dose) in each period|Pharmacokinetic (PK) Evaluable: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
26404|NCT01662986|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Time to event: Time to recovery (EXACT-PRO) was not analysed, only Kaplan Meier curve was plotted.~Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day’s score was transformed to the mean score using a rolling 3-day average."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years||||||
26405|NCT01662986|Secondary|Exposure of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of all-cause hospitalization was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.||patient years|||Number
26406|NCT01662986|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.||hospitalizations per patient year|||Number
26407|NCT01662986|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.~Time to the next adverse clinical outcome event from the Two Twin Trials, present 205.478 (NCT01662986) and 205.477 (NCT01663987) was not analysed, only Kaplan Meier curve was plotted. So this endpoint has not been disclosed.~This endpoint was analysed using combined data, as specified in the analysis plan"|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477 : This set includes all patients who were randomized and took at least one dose of the study drug, 157 patients (79 tiotropium and 78 placebo) were included in this set.||Percentage of participants|||Number
27284|NCT01648582|Secondary|Change From Baseline in Body Weight||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||kilogram (kg)||Standard Error|Least Squares Mean
26410|NCT01662986|Secondary|Percentage of Patients With 30-day Hospital Readmission Rates Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with 30-day hospital readmission rates outcome events was analysed.~Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.~The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS."|from date of hospital discharge prior to randomization upto readmission days >1 and <31 days|Treated Set of the pooled twin studies 205.478 and 205.477||percentage of participants|||Number
26411|NCT01662986|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.~All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures.~Hospitalizations occurring on the same day as discharge were not considered a separate admission."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477||percentage of participants|||Number
26412|NCT01662986|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with COPD exacerbation on study was analysed for the combined study.~A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following:~1) Shortness of breath; 2) Sputum production (volume) ; 3) Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness.~Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.~A required change in treatment included either prescription of antibiotics and/or systemic steroids; and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines and PDE4-inhibitors)."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477||percentage of participants|||Number
26413|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.||Litres||Standard Deviation|Mean
26414|NCT01662986|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.||Litres||Standard Deviation|Mean
26415|NCT01662986|Secondary|Percentage of Patients With Adverse Clinical Event During on Study.|Percentage (number) of patients with adverse clinical event on study, which is defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set (TS)||percentage of participants|||Number
26416|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug.|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|baseline and 12 weeks|Treated Set (TS). The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.||Litres||Standard Deviation|Mean
26417|NCT01662986|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug.|"Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and 12 weeks|Treated Set (TS): The treated set included all patients randomized and who took at least one dose of the study drug. The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.||Litres||Standard Deviation|Mean
26418|NCT01662882|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection|||SUVR||Standard Deviation|Mean
26419|NCT01662882|Primary|Qualitative Amyloid Image Assessment|Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection|||participants|||Number
26420|NCT01662791|Secondary|Paffenbarger Physical Activity Questionnaire (PPAQ)|"The PPAQ is a validated, self-administered questionnaire that asks for a recall of physical activity of physical activity over the previous 1-week. From the answers to the questions, a physical activity index (PAI) can be computed, providing an estimate of energy expenditure in kcal/week.~The PAI can be estimated using a list of the physical activities a person performs within a time period and the amount of time spent on each activity, e.g. walking to work, light housework, swimming, carrying bricks at work, or whatever applies to an individual person. There is a value called the physical activity ratio for each activity. The list of activities is used to find the relevant values of physical activity ratios, then an overall physical activity level value for the time period is calculated, using time-weighted averages of the physical activity ratios.~This assessment was only measured at baseline."|Baseline|||kcal/week||Standard Deviation|Mean
26421|NCT01662791|Secondary|Weight Change in Case Group After Treatment|Weight change after treatment|baseline, 3 months|||participants|||Number
26689|NCT01658904|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months and 15 days|Analysis of dose limiting toxicities (DLTs) was planned but not performed due to study termination; this Outcome Measure captures any events that occurred.||participants|||Number
26422|NCT01662791|Other Pre-specified|Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)|"The FFQ is a validated, self-administered semi-quantitative questionnaire used to assess differences in macronutrient, and energy intake. It was designed to provide estimates of usual and customary dietary intake. This questionnaire contains a food list of about 70 food items.~A Food Frequency Questionnaire (FFQ) is a limited checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed over a specified period of time. Semi-quantitative FFQs collect portion size information as standardized portions or as a choice of portion sizes. Calculations for nutrient intake or calories can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient or calories in a serving of that food."|Baseline|||Calories||Standard Deviation|Mean
26423|NCT01662791|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a self-administered 14-item questionnaire (seven for anxiety and seven for depression) Items are rated on a 4-point scale from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The cut-offs used for identifying significant psychiatric distress was >/= 8. This assessment was only measured at baseline|Baseline|||units on a scale||Standard Deviation|Mean
26424|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|baseline, 3 months|||units on a scale||Standard Deviation|Mean
26425|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI)|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
26426|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
26427|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39)|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|baseline|||units on a scale||Standard Deviation|Mean
26428|NCT01662791|Primary|Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)|SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane.|Baseline to 2 hours|||participants|||Number
26429|NCT01662765|Other Pre-specified|Costs|from initial treatment to the complete healing, all kind of cost will be calculated.|two year|||USD dollars||Standard Deviation|Mean
26430|NCT01662765|Secondary|Visual Analogue Scale for Patient Satisfaction (VAS-PS)|Well-being and satisfaction scales comprised linear metric scales known as “visual analogue scales,” with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).|30 days|||units on a scale||Standard Deviation|Mean
26431|NCT01662765|Secondary|Healing Time|the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.|two year|||days||Standard Deviation|Mean
26432|NCT01662765|Primary|Cure Rate|"Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure.~Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy."|2 year after initial treatment|Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed||participants|||Number
27580|NCT01644474|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Apo-B ITT population.||percent change||Standard Error|Least Squares Mean
26433|NCT01662648|Secondary|Number of Participants Within Each Category of Patient Satisfaction Score|Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure and n signifies those participants who were evaluated for this measure at specified time point."||participants|||Number
26434|NCT01662648|Secondary|Change From Baseline in Daytime Drowsiness at Week 26|"Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: not at all to 100:all the time). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."||millimeter (mm)||Standard Deviation|Mean
26435|NCT01662648|Secondary|Change From Baseline in Sleep Quality at Week 26|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: very badly to 100: very well). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."||millimeter (mm)||Standard Deviation|Mean
26436|NCT01662648|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."||units on a scale||Standard Deviation|Mean
26437|NCT01662648|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
26438|NCT01662648|Secondary|Change From Baseline in PANSS Total Negative Subscale Score at Week 26|The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
26439|NCT01662648|Secondary|Change From Baseline in PANSS Total Positive Subscale Score at Week 26|The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
26455|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination|Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.|Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.||Number of Subjects|||Number
26750|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day|Phonophobia is sensitivity to sound.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26440|NCT01662648|Secondary|Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||percentage of participants|||Number
26441|NCT01662648|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||units on a scale||Standard Deviation|Mean
26442|NCT01662635|Primary|FISH, IHC, RT-qPCR Comparison|200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.|TWO YEARS|The only selection criteria of our subjets was the availability of tumor tissue to perform tests.||participants|||Number
26443|NCT01662583|Secondary|Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.||by 42 days after dose of first vaccination|One patient in the plain text message arm was removed for this analysis because they received the second dose too early and was not re-vaccinated||percentage of participants|||Number
26444|NCT01662583|Primary|Receipt of 2nd Dose of the Influenza Vaccine.||by April 30th after receipt of first dose (up to 8 months)|||percentage of participants|||Number
26445|NCT01662531|Secondary|Consumption of rIX-FP During Routine Prophylaxis|Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.|12 months|Efficacy Population||IU/kg/month||Standard Deviation|Mean
26446|NCT01662531|Secondary|Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis|For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis|Approximately 12 months|Efficacy Population||bleeding episodes|||Number
26447|NCT01662531|Secondary|Number of Subjects Developing Antibodies Against rIX-FP|Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).|12 months|Safety Population||participants|||Number
26448|NCT01662531|Secondary|Number of Subjects With Treatment-related Adverse Events||12 months|Safety Population||participants|||Number
26449|NCT01662531|Primary|Number of Subjects Developing Inhibitors to Factor IX (FIX)|Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.|12 months|Safety Population||participants|||Number
26450|NCT01662531|Primary|Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population||mL/hr/kg||Standard Deviation|Mean
26451|NCT01662531|Primary|Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)|"AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.~FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values."|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population||IU*hr/dL||Standard Deviation|Mean
26452|NCT01662531|Primary|Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population||hours||Standard Deviation|Mean
26453|NCT01662531|Primary|Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.|30 minutes after infusion|PK Population||(IU/dL)/(IU/kg)||Standard Deviation|Mean
26454|NCT01662440|Secondary|Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57|Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.|Day 1 through Day 57|Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.||Number of subjects|||Number
26820|NCT01656850|Primary|Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mg/dL||Standard Deviation|Mean
26456|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection|Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R – Conv and JE – Conv groups), day 4 through day 10 (injection on day 4; in R/JE – Conv, R – Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE – Conv, R – Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE – Acc, R – Con and JE – Conv groups).|Day 1 through day 7 after each injection (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.||Number of Subjects|||Number
26457|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination|Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE – Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE – Con and JE – Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 8 and 29)|Analysis was done on the solicited safety set.||Number of subjects|||Number
26458|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination|Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE – Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE – Conv and R – Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)|Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.||Number of subjects|||Number
26459|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as PRNT50 GMTs|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)|Analysis was done on the PP dataset.||Titers||95% Confidence Interval|Geometric Mean
26460|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Days 1, 15, 22, 36, 57, 91, 181 and 366|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
26461|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as the RVNA GMCs|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181, and 366|Analysis was done on the PP dataset.||IU/mL||95% Confidence Interval|Geometric Mean
26462|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181 and Day 366|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
26463|NCT01662440|Secondary|Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.~As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs JE – Conv."|Day 15 and day 36 (28 after last active vaccination)|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
26464|NCT01662440|Secondary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.~As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs R – Conv."|Day 36 and day 57 (28 days after last active vaccination)|Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
26465|NCT01662440|Secondary|PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination|"Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.~Data were adjusted using ANOVA model, as per protocol specifications."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.||Titers||95% Confidence Interval|Geometric Mean
26466|NCT01662440|Secondary|RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination|"Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.~Data were adjusted using ANOVA model, as per protocol specification."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.||IU/mL||95% Confidence Interval|Geometric Mean
26467|NCT01662440|Primary|Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.~As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs JE – Conv."|Day 28 after last active vaccination (day 36 – group that received accelerated schedule, day 57 – group that received conventional schedule)|Analysis was done on the PP dataset.||Percentages of subjects||95% Confidence Interval|Number
26821|NCT01656850|Primary|The Major Nutrients of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months|||% of energy||Standard Deviation|Mean
26468|NCT01662440|Primary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.~As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs R – Conv."|Day 7 after last active vaccination (day 15 – group that received accelerated schedule, day 36 – group that received conventional schedule)|Analysis was done on the per-protocol (PP) dataset, ie, the subjects who received the vaccine correctly, provided evaluable serum samples at the relevant time points, and had no major protocol violations as defined prior to unblinding.||Percentages of subjects||95% Confidence Interval|Number
26469|NCT01662362|Secondary|ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas||Up to six months|||percentage of specimens ESA negative||95% Confidence Interval|Number
26470|NCT01662362|Primary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas||Up to six months|||percent agreement to RIPA||95% Confidence Interval|Number
26471|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
26472|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
26473|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
26474|NCT01662310|Secondary|Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).|DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).||Days||95% Confidence Interval|Median
26475|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."||Millimeter (mm)||Standard Deviation|Mean
32020|NCT01569763|Secondary|Procedure Time|Procedure time is defined as the time from device insertion to time of device removal.|< 1 hour|Subjects completing treatment||Minutes||Standard Deviation|Mean
26476|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."||Millimeter (mm)||Standard Deviation|Mean
26477|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."||Millimeter (mm)||Standard Deviation|Mean
26478|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."||Millimeter (mm)||Standard Deviation|Mean
26479|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.||Units on a scale||Standard Deviation|Mean
26480|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."||Units on a scale||Standard Deviation|Mean
26481|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.||Units on a scale||Standard Deviation|Mean
26482|NCT01662310|Secondary|Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point."||Participants|||Number
26483|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
26484|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values."||Units on a scale||Standard Deviation|Mean
26485|NCT01662310|Primary|Double Blind (DB) Phase: Median Time to Relapse|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.|DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). N (number of participants analyzed) signifies the participants evaluable for this measure."||Days||95% Confidence Interval|Median
26486|NCT01662102|Primary|Progression Free Survival|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.|24 months|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.|||||
26487|NCT01662102|Secondary|Pharmacoeconomics (Cost Effectiveness Analysis)|A cost-effectiveness analysis will be done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis will be conducted according to a health economic analysis plan independent from this clinical study protocol.|Up to 24 months||||||
26488|NCT01662102|Secondary|Quality of Life (QoL)|QoL will be assessed through EORTC FACT-G and QLQ-[C]30 questionnaires, and will be compared at each specified time point between treatment arms.|Up to 7 years||||||
26489|NCT01662102|Secondary|Transformation at First Progression|Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.|Up to 7 years||||||
26490|NCT01662102|Secondary|Overall Response Rate (ORR)|Tumor response will be evaluated according to Cheson criteria at the time of randomization and at the end of the 2-year maintenance/observation, post randomization. ORR is defined as the proportion of patients with a CR or a PR, and will be compared between treatment groups. Patients with no response evaluation (for any reason) will be considered as not evaluable (NE).|Up to 7 years||||||
26491|NCT01662102|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause. In living patients, survival time will be censored on the last date patients were known to be alive.|Up to 7 years||||||
26492|NCT01662102|Secondary|Time to Next Chemotherapy (TTNCT)|TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Patients who respond to treatment and patients who are lost to follow-up will be censored at the visit on which the dosing of a new medication was evaluated.|Up to 7 years||||||
26493|NCT01662102|Secondary|Time to Next Anti-Lymphoma Treatment (TTNLT)|TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.|Up to 7 years||||||
26494|NCT01662102|Secondary|Time to Progression (TTP)|TTP is defined as the time from randomization to the first disease progression.|Up to 7 years||||||
26495|NCT01662102|Secondary|Event Free Survival|EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).|Up to 7 years||||||
26496|NCT01662102|Secondary|Complete Response Rate|Complete Response (CR) rates post randomization|Up to 24 months||||||
26497|NCT01662063|Secondary|Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||percentage of participants|||Number
26506|NCT01662063|Secondary|Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||mm||Standard Deviation|Mean
26498|NCT01662063|Secondary|Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||participants|||Number
26499|NCT01662063|Secondary|Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||percentage of participants|||Number
26500|NCT01662063|Secondary|Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||participants|||Number
26501|NCT01662063|Secondary|Percentage of Participants With HAQ-DI Score <0.5|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score <0.5 was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||percentage of participants|||Number
26502|NCT01662063|Secondary|Change From Baseline in HAQ-DI Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
26503|NCT01662063|Secondary|Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||units on a scale||Standard Deviation|Mean
26504|NCT01662063|Secondary|Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||mm||Standard Deviation|Mean
26505|NCT01662063|Secondary|Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||mm||Standard Deviation|Mean
26507|NCT01662063|Secondary|Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||mm||Standard Deviation|Mean
26508|NCT01662063|Secondary|Time to Return to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included.||weeks||Full Range|Median
26509|NCT01662063|Secondary|Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen were included.||participants|||Number
26510|NCT01662063|Secondary|Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).||percentage of participants|||Number
26511|NCT01662063|Secondary|Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).||participants|||Number
26512|NCT01662063|Secondary|Percentage of Reasons Given for CCS Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation >14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS discontinuation >14 days were included.||percentage of reasons|Participants||Number
26513|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Interruption|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption.||percentage of reasons|Participants||Number
26514|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Reduction|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose reduction were included.||percentage of reasons|Participants||Number
26515|NCT01662063|Secondary|Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.||percentage of participants|||Number
26516|NCT01662063|Secondary|Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.||participants|||Number
26517|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD discontinuation >60 days were included.||percentage of reasons|Participants||Number
27571|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
26518|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Dose Reduction or Interruption|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included.||percentage of reasons|Participants||Number
26519|NCT01662063|Secondary|Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.||percentage of participants|||Number
26520|NCT01662063|Secondary|Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.||participants|||Number
26521|NCT01662063|Secondary|Change From Baseline in SJC Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||swollen joints||Standard Deviation|Mean
26522|NCT01662063|Secondary|Swollen Joint Count (SJC) Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||swollen joints||Standard Deviation|Mean
26523|NCT01662063|Secondary|Change From Baseline in TJC Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||tender joints||Standard Deviation|Mean
26524|NCT01662063|Secondary|Tender Joint Count (TJC) Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||tender joints||Standard Deviation|Mean
26525|NCT01662063|Secondary|Change From Baseline in SDAI Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
26526|NCT01662063|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
26527|NCT01662063|Secondary|Change From Baseline in CDAI Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
26528|NCT01662063|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.||units on a scale||Standard Deviation|Mean
26529|NCT01662063|Secondary|Change From Baseline in DAS28 Score|The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
26530|NCT01662063|Secondary|Disease Activity Score Based on 28 Joints (DAS28) Score|The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."||units on a scale||Standard Deviation|Mean
26531|NCT01662063|Secondary|Percentage of Participants Who Correctly Administered All SC TCZ Doses|Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (>) 8 hours, and absence of other medication errors.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.||percentage of participants|||Number
26532|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.|From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.||percentage of participants|||Number
26533|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|Baseline|Safety Population; only participants with a valid assay at Screening were included.||percentage of participants|||Number
26534|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.||percentage of participants|||Number
26535|NCT01662063|Primary|Percentage of Participants With at Least One SAE|AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.||percentage of participants|||Number
26536|NCT01662063|Primary|Number of Participants With at Least One Serious Adverse Event (SAE)|Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.||participants|||Number
26575|NCT01661140|Secondary|Percentage of Participants Who Achieve a Disease Activity Score In 28 Joints (DAS28) <= 3.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve score <=3.2 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26537|NCT01661933|Secondary|Serum Anti-tissue Transglutaminase Antibodies Measured as International Units/mL (IU/mL)|The trial was extended with pre-trial and mid-trial anti-tTG antibody levels used to compare with the post-trial levels. Anti-tTG is a serological measure of tissue transglutaminase-2 antibodies. In active celiac disease, levels are increased. In treated disease, levels are low (normal cut-off was <15 IU/mL). A significant increase compared to baseline in tTG can be expected 2 weeks after consuming 3g of gluten daily for 2 weeks in people with celiac disease who have been maintaining a gluten-free diet, but who are not taking other treatment.|Anti-tTG IU/mL levels pre-trial, mid-trial and after 3 gram/day gluten challenge|2 of 12 participants did not progress past baseline micro-challenge, 2 of 10 participants did not progress past low-dose challenge.||International Units/mL||95% Confidence Interval|Mean
26538|NCT01661933|Secondary|Number of Participants With 2 Points Increase in Marsh Score Post GC-1g|The Marsh score is a defined but qualitative assessment assigned a value to allow for comparison. The scores were evaluated by consensus between the primary (chief) investigator and the study pathologist. The Marsh score was graded 0, 1, 2, 3A (assigned-4), 3B (-5) and 3C (-6); rage 1-6 with normal=0 and severe inflammation=6. Because the scoring is vulnerable to artefact, only a 2-point shift was regarded as a significant intra-individual change. The scores were graded after week-36 on biopsies de-identified shuffled. An upward shift was interpreted to reflect a significant worsening of gluten-associated inflammation. The comparison reported evaluated changes from baseline (week-24) to post-low-dose gluten challenge (week-24; GC-1g). The objective for using the Marsh score was to identify individuals who might have experienced a severe worsening in pathology due to GC-1g that might not be reflected in the Vh:Cd group analysis.|Longitudinal change between week-24 and week-36|The outcome score was the number with a 2-point increase in Marsh 3 score post GC-1g.||participants|||Number
26539|NCT01661933|Secondary|Intraepithelial Lymphocyte Count|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with anti-CD3. All slides were de-identified and graded by Dr John Croese. The IEL percentages were measured on 2 or more randomly selected well-orientated villi. The null hypothesis is that hookworm infection will not protect against mucosal IEL influx following 12-week exposure to gluten in celiac disease.|Week-24 and -36|||Percentage of epithelial cells||95% Confidence Interval|Mean
26540|NCT01661933|Primary|Duodenal Villus Height:Crypt Depth|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with H&E. Slides from both time-points were de-identified, shuffled and graded by Dr John Croese after which results from poorly orientated slides were verified by Dr Andrew Clouston. The Vh:Cd ratios were measured on 5 randomly selected well-orientated sites. The null hypothesis is that hookworm infection will not protect against mucosal damage following 12-week exposure to gluten in celiac disease.|Week -24 to -36|All 10 of 12 participants who completed micro-challenge successfully progressed and completed low-dose challenge.||Ratio||95% Confidence Interval|Mean
26541|NCT01661881|Secondary|Autologous Stem Cell Transplant (ASCT) Rate|ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)|All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction.|||proportion of participants||90% Confidence Interval|Number
26542|NCT01661881|Secondary|1 Year Progression-Free Survival|1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).|Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months.|The analysis dataset is comprised of all enrolled patients.||probability||90% Confidence Interval|Number
26543|NCT01661881|Primary|Complete Remission (CR) Rate After 6 Cycles|The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.|Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.|The analysis dataset is comprised of all enrolled patients.||proportion of participants||90% Confidence Interval|Number
26544|NCT01661790|Other Pre-specified|Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)||before intrapleural administration||||||
26545|NCT01661790|Secondary|Qualify of Life (QoL)||baseline to biweekly,until death||||||
26546|NCT01661790|Secondary|Adverse Reactions||Up to 1 month after the last treatment||||||
26547|NCT01661790|Secondary|Overall Survival (OS)||randomization to four weeks,until death||||||
26548|NCT01661790|Secondary|Median Progression Free Survival (PFS)||baseline to biweekly,until disease progression||||||
26549|NCT01661790|Primary|"Number of Participants With Complete Response and Partial Response"|Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR|from randomization, This treatment was given every two weeks,responses were made by biweekly|||participants|||Number
26550|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day|"Efficacy:~Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The IPSS quality of life question score on a 7-point scale ranging from 0 Delighted to 6 Terrible.~IPSS-QoL ranges 0 to 6 (Delighted to Terrible)~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
27572|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
26551|NCT01661621|Secondary|The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day|"Efficacy:~Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
26552|NCT01661621|Secondary|The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day|"Efficacy:~Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
26553|NCT01661621|Secondary|The Postvoid Residual Volume (PVR) After the Treatment Day|"Efficacy:~Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||mL||Standard Deviation|Mean
26554|NCT01661621|Secondary|The Voided Volume After the Treatment Day|"Efficacy:~Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||mL||Standard Deviation|Mean
26555|NCT01661621|Secondary|The Maximum Flow Rate (Qmax) After the Treatment Day|"Efficacy:~Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||mL/s||Standard Deviation|Mean
26556|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day|"Efficacy:~Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
26557|NCT01661621|Primary|The Global Response Assessment (GRA) After the Treatment Day|"Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The global response assessment on a 6-point scale ranging from 1 No problems at all to 6 Many severe problems.~Changes of the global response assessment (GRA) improved or reduction by 1 points.~Change = Baseline minus Month 1 value~Safety:~Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness"|1 month after initial treatment|||participants|||Number
26558|NCT01661270|Secondary|Percentage of Participants With Objective Response|Objective response rate was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR), as assessed by Investigators and the IRC according to RECIST 1.0 criteria, relative to the total number of participants in the relevant analysis population. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|26.6 months|ITT population.||percentage of participants||95% Confidence Interval|Number
26559|NCT01661270|Secondary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the earliest between the last date of the participants was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|31.6 months|ITT population.||months||95% Confidence Interval|Median
26560|NCT01661270|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of first observation of either tumor progression or death due to any cause. Tumor assessment was performed by Independent Review Committee (IRC) as per response evaluation criteria in solid tumors (RECIST) version 1.0. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates.|26.7 months|Intent-to-Treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
26561|NCT01661179|Primary|Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib|ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.|Sept 2012 to May 2014|All patients with post-baseline efficacy assessments||percentage of participants||95% Confidence Interval|Number
26562|NCT01661140|Secondary|Change in Productivity and Regular Daily Activities Affected by Rheumatoid Arthritis Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Assessments were made using a visual analogue scale ranging from 0 to 10 where 0 = minimum impact and 10 = maximum impact.|Randomization (Week 24), Week 60, 72|Participants in the ITT population with available data at the respective time points were analyzed.||units on a scale||Full Range|Median
26563|NCT01661140|Secondary|Hours Actually Worked and Work Hours Missed Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Reported here are hours actually worked, work hours missed due to rheumatoid arthritis (RA), work hours missed due to other reasons and the change from Week 24 for each of these parameters reported at Week 60 and Week 72.|Randomization (Week 24), Week 60, Week 72|Participants in the ITT population with available data were analyzed.||hours||Full Range|Median
26564|NCT01661140|Secondary|Number of Subjects Employed Assessed Using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||participants|||Number
26565|NCT01661140|Secondary|Percentage of Participants Able to Discontinue Methotrexate||Week 0 up to Week 60|Data were not collected for this outcome measure.|||||
26566|NCT01661140|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any adverse event that can be fatal, life threatening, requires long or prolong hospitalization, results in persistent or significant disability/incapacity, congenital anomaly or significant medical event in the investigator’s judgment.|Week 0 up to Week 72|Safety population included all the randomized participants.||participants|||Number
26567|NCT01661140|Secondary|Percentage of Participants With Anemia||Week 0 up to Week 72|Safety population included all the randomized participants.||percentage of participants|||Number
26568|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using 12-item Short Form Health Survey [SF-12]) at Week 60 and 72|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in SF-12 score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26569|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-F] at Week 60 and 72|The FACIT-fatigue assessment was a 13-item questionnaire with participants scoring each item on a 5-point scale (not at all; a little bit; somewhat; quite a bit and very much). The total score ranges from 0 to 65 and higher scores indicate more fatigue. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in total FACIT score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26570|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Health Assessment Questionnaire [HAQ] at Week 60 and 72|The HAQ-disability index (DI) evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of participants with an improvement in HAQ-DI score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26571|NCT01661140|Secondary|Percentage of Participants Who Achieve Simplified Disease Activity Index (SDAI) Remission (SDAI < 3.3) at Week 60 and 72|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26572|NCT01661140|Secondary|Percentage of Participants Who Achieve Clinical Disease Activity Index (CDAI) Remission (CDAI < 2.8) at Week 60 and 72|Clinical Disease Activity Index (CDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + patient global assessment of disease (PGA) 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26573|NCT01661140|Secondary|Percentage of Participants Who Achieve Change in Disease Activity Score (cDAS) >=1.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve cDAS28 >=1.2 score at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26574|NCT01661140|Secondary|Percentage of Participants Who Achieve DAS28 Remission (DAS28 < 2.6)|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve DAS28 remission score <2.6 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26576|NCT01661140|Secondary|Percentage of Participants Who Achieve Score of <=1 in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 60 and 72|Percentage of participants who achieve score of =1 in TJC and SJC at week 60 and 72 were reported. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Week 60, 72|ITT population included all randomized participants.||percentage of participants|||Number
26577|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 72|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 72|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
26578|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 60|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 60|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this end point.||units on a scale||Standard Deviation|Mean
26579|NCT01661140|Primary|Percentage of Participants Maintaining Previous Disease Activity (European League Against Rheumatism [EULAR] Response) From Week 24 (Time of Randomization) to Week 60|Response was determined using EULAR criteria based upon (Disease Activity Score In 28 Joints) DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (<=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'|From randomization to Week 60|Intention to treat (ITT) population included all randomized participants.||percentage of participants|||Number
26580|NCT01661114|Secondary|Median Overall Survival of Previously Treated and Previously Untreated Patients|To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin.|1 year|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.||Months||95% Confidence Interval|Median
26581|NCT01661114|Primary|The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment|"The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients.~Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|28 days|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.||percentage of patients||95% Confidence Interval|Number
26582|NCT01661062|Primary|Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate|Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).|24 months|36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.||correlation coefficient|||Number
26583|NCT01661062|Secondary|The Median Delivered Dose of Radiation to the Parotid Gland||7 weeks|||Gy||Full Range|Median
26584|NCT01661062|Secondary|Improvement of Image Quality|Use acquired data to further improve cone beam CT reconstruction techniques and image quality.|36 months||||||
26585|NCT01661062|Primary|Rate of Movement of Normal Tissue|The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.|approximately 7 weeks||||||
26586|NCT01660906|Other Pre-specified|Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib|Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. MR4.5, the number of treated participants with BCR-ABL transcripts ≤ 0.0032% (IS) at 6 and 12 months from the date of dasatinib initiation; MMR, Major Molecular Response = 3-log reduction in BCR-ABL gene transcripts from a standardized baseline.|6 and 12 months|All treated participants.||Participants|||Count of Participants
26587|NCT01660906|Secondary|The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib|Dasatinib treatment was administered and its impact on the Imatinib-related Grade 1/2 adverse events was assessed. The percentage of participants is based on the number that had pre-existing Imatinib-related AEs. Measure assesses the participants with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after Dasatinib treatment. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method.|3 months|All treated participants.||percentage of participants||95% Confidence Interval|Number
26588|NCT01660906|Secondary|Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib.|Date of first dose to 30 post last dose of study drug, an average of 3 years|All treated participants.||Participants|||Count of Participants
26589|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib|The EORTC QLQ-C30 questionnaire is completed by study participants to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represents a healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale and single-item measures represents a high level of problematic symptomatology.|Baseline to 6, 12 months|All treated participants||units on a scale||Standard Deviation|Mean
26590|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib|The MD Anderson Symptom Inventory Chronic Myeloid Leukemia (MDASI-CML) is a validated questionnaire completed by study participants to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to Dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely.|Baseline to 3, 6, 12 months|All treated participants.||units on a scale||Standard Deviation|Mean
26591|NCT01660906|Primary|The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment|Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased.|3 months after switch to dasatinib|All treated participants.||adverse event(s)|||Number
26592|NCT01660815|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.|0-360 minutes|Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.||mSv/MBq||Standard Deviation|Mean
26593|NCT01660802|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients||Percentage of Patients|||Number
26594|NCT01660802|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients||Letters Read Correctly||Standard Deviation|Mean
26595|NCT01660802|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients||Letters Read Correctly||Standard Deviation|Mean
26596|NCT01660802|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients||Patients|||Number
26616|NCT01659736|Primary|Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.|Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up|Intent-to-treat sample (n = 25)||units on a scale||Standard Deviation|Mean
26597|NCT01660763|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. Range of SPID48 scores were -239 to 417.~Time-weighted SPID48 = ∑ [T(i) – T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours"|48 hours|||Units on a scale||Standard Error|Least Squares Mean
26598|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1, and 2 months|||ng/mL||Standard Deviation|Mean
26599|NCT01660698|Secondary|Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks||||||
26600|NCT01660698|Secondary|Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups||8 weeks||||||
26601|NCT01660698|Secondary|Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks||||||
26602|NCT01660698|Secondary|Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)|TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.|Measures at baseline, 1, and 2 months|||units on a scale||Standard Deviation|Mean
26603|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1 and 2 months|||ng/mL||Standard Error|Mean
26604|NCT01660672|Other Pre-specified|Mean Time to Return to a BCS Score Greater Than or Equal to 4|Mean time from admission to a BCS score greater than or equal to 4. The BCS (Blantyre Coma Scale) is a 0-5 scale measuring motor response, verbal response and eye movement assessing the severity of coma in children with cerebral malaria. Lower scores correspond to more profound coma.|7 days|||hours||Full Range|Mean
26605|NCT01660672|Other Pre-specified|Number of Participants Requiring AED During Admission|Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission.|7 days|||participants|||Number
26606|NCT01660672|Other Pre-specified|Number of Subjects Exposed to Phenobarbitone Prior to Enrollment|Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated.|0 hour|||participants|||Number
26607|NCT01660672|Other Pre-specified|Number of Subjects With Retinopathy at Enrollment|Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic.|Upon admission|||participants|||Number
26608|NCT01660672|Other Pre-specified|Number of Participants With Neurologic Sequelae at Discharge|Number of participants with neurologic sequelae at discharge|day 7|||participants|||Number
26609|NCT01660672|Secondary|Range of Plasma Concentration of LVT Across All Individuals|Range of plasma LVT concentrations will be determined through HPLC method at eight timepoints post administration to evaluate LVT absorption and elimination in pediatric CM.|72 hours|||mcg/ml||Full Range|Mean
26610|NCT01660672|Secondary|Toxicity Related to LVT|Toxicity including vomiting, aspiration, complications related to the NGT, laboratory parameters at 24 hours and 1 week post LVT administration, and an overall acute case fatality rate significantly above the consistent historical ward average for CM. Pk studies to evaluate LVT absorption and elimination in pediatric CM.|1 week|||participants|||Number
26611|NCT01660672|Primary|Freedom From Seizure|Number of subjects free of seizure at 24 hours after initiation of treatment|24 hours|||individuals|||Number
26612|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at 3-month follow-up."|3-month follow-up|3-month follow-up completers||participants|||Number
26613|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.|3-month follow-up|3-month follow-up completers||participants|||Number
26614|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at post-treatment."|post-treatment, 6 weeks|Post-treatment completers||participants|||Number
26615|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.|Post-treatment, 6 weeks|Post-treatment completers||participants|||Number
26617|NCT01659554|Secondary|Kaplan-Meier Curves for Patient Overall Survival|Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).|Up to 5 years, survival|zero participants analyzed due to early termination of study|||||
26618|NCT01659554|Secondary|Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)|Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.|Up to 5 years (survival)|zero participants analyzed due to early termination of study|||||
26619|NCT01659554|Primary|Toxicity Rating Based on NCI Common Toxicity Criteria|Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).|Up to 5 years|zero participants analyzed due to early termination of study|||||
26620|NCT01659554|Primary|Adverse Event Rate and/or Laboratory Changes|The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.|5 years|zero participants analyzed due to early termination of study|||||
26621|NCT01660334|Secondary|Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.|"The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.~Clinical response of cure was assessed comprehensively by physicians in the three categories, which were effective, ineffective, and not evaluable, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests."|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
26622|NCT01660334|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
26623|NCT01660321|Primary|AUC (0-12) for Benzyl Alcohol|Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Since the only benzyl alcohol concentrations above Limit of Quantitation (LOQ) (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC (0-12) was not summarized.||μg*hr/mL|||Number
26624|NCT01660321|Primary|Tmax for Benzyl Alcohol|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol||hours||Full Range|Median
26625|NCT01660321|Primary|Cmax for Benzyl Alcohol|Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol||μg/mL||Standard Deviation|Mean
26626|NCT01660321|Primary|AUC (0-12) for Spinosyn D|Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng* hr/mL|||Number
26627|NCT01660321|Primary|Tmax for Spinosyn D|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||hours|||Number
26628|NCT01660321|Primary|Cmax for Spinosyn D|Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng/mL|||Number
26629|NCT01660321|Primary|AUC (0-12) for Spinosyn A|Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng*hr/mL|||Number
26630|NCT01660321|Primary|Tmax for Spinosyn A|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||hours|||Number
26631|NCT01660321|Primary|Cmax for Spinosyn A|Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.||ng/mL|||Number
26661|NCT01660022|Primary|Piperaquine AUC(0-168)|Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
26632|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL||Standard Deviation|Mean
26633|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL/h||Standard Deviation|Mean
26634|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h||Standard Deviation|Mean
26635|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||l/h||Standard Deviation|Mean
26636|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
26637|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
26638|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL||Standard Deviation|Mean
26639|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL/h||Standard Deviation|Mean
26640|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h||Standard Deviation|Mean
26641|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||l/h||Standard Deviation|Mean
26642|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
26643|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
26644|NCT01660230|Secondary|Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL||Standard Deviation|Mean
26645|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||mL/h||Standard Deviation|Mean
26646|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h||Standard Deviation|Mean
26647|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||l/h||Standard Deviation|Mean
26648|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
26649|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||h x ng/mL||Standard Deviation|Mean
26650|NCT01660230|Secondary|Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||hour (from start of infusion)||Full Range|Median
26651|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
26652|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.||Day 6 for multiple-dose cohorts|All 'multiple-dose' subjects who received at least one dose of study treatment.||participants|||Number
26653|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.||Day 4 for single-dose cohorts|All 'single-dose' subjects who received at least one dose of study treatment.||participants|||Number
26654|NCT01660191|Secondary|Changes HDL Particle Number and LDL Particle Number|Change in levels will be measured by difference in levels at 12 weeks.|Change from Baseline to 12 Weeks|||particle number||Standard Deviation|Mean
26655|NCT01660191|Secondary|Changes to Glucose Metabolism - Fructosamine|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.|Change from Baseline to 12 weeks|||µmol||Standard Deviation|Mean
26656|NCT01660191|Secondary|Changes in HDL and LDL Size|Change in levels will be measured by difference in levels at 12 weeks|Change from Baseline to 12 Weeks|||nanometre (nm)||Standard Deviation|Mean
26657|NCT01660191|Secondary|Changes to Glucose Metabolism - HbA1c and Insulin|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.|Change from Baseline to 12 weeks|||percentage change from baseline measure||Standard Deviation|Mean
26658|NCT01660191|Secondary|Changes in Major Lipid Parameters - VLDL Size|Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.|Change from Baseline to 12 Weeks|||nanometre (nm)||Standard Deviation|Mean
26659|NCT01660191|Primary|Changes in Plasma CoQ10 Levels|Change in levels will be measured by taking difference between Baseline and Week 12 measures.|Change from Baseline to 12 Weeks|||μg/g||Standard Deviation|Mean
26660|NCT01660022|Primary|Piperaquine t1/2|Piperaquine Elimination half-life (t1/2).|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.||hour||Geometric Coefficient of Variation|Geometric Mean
26666|NCT01659996|Primary|Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|"Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test.~The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3."|Day 30 post-vaccination 2|Antibody responses to Diphtheria, Tetanus, and Polyribosylribitol phosphate antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.||Percentage of Participants|||Number
26667|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after the 15 to 18 month vaccination|Solicited reactions were assessed in all subjects who received at least one dose of 15 to 18 month study vaccine, according to the vaccine actually received (Safety Analysis Population).||Percentage of participants|||Number
26668|NCT01659996|Primary|Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is <4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ|Day 30 post-vaccination 2|Antibody responses to Pertussis vaccine antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.||Percentage of Participants|||Number
26669|NCT01659996|Primary|Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination 2|Geometric Mean Concentrations (GMC) of Pertussis vaccine antibodies were assessed in the Per-protocol population of participants in Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group.||Titers||95% Confidence Interval|Geometric Mean
26670|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine.|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after 9-month vaccination|Solicited reactions were assessed in subjects who received at least one dose of study vaccine at 9 month of age, according to the vaccine actually received (Safety Analysis Population).||Percentage of participants|||Number
26671|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable.|Day 0 to Day 7 after any vaccination|Solicited reactions were assessed in all subjects who received at least one dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).||Percentage of participants|||Number
26672|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test.|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual vaccine antibodies were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and the Pentacel Vaccine Group participants.||Titers||95% Confidence Interval|Geometric Mean
26673|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual antibodies were assessed in the Per-protocol population in the Menactra Vaccine Group and Menactra + Pentacel Vaccine Group participants.||Titers||95% Confidence Interval|Geometric Mean
30295|NCT01600287|Secondary|Global Score|overall performance assessment of the system calculated as= [(MDAPE+Wobble)/percentage of time BIS remains within target]x100 Lower score indicates better overall performance|8 hours (approx)|||percentage of time||Standard Deviation|Mean
26674|NCT01659996|Primary|Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination|"Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC).~Menactra vaccine response defined as subjects with an hSBA titer <1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer."|Day 30 post second Menactra vaccination|Antibody titers to the meningococcal serogroups were assessed in the Per-protocol population of the participants in Menactra Vaccine Group and Menactra + Pentacel Vaccine Group.||Percentage of participants|||Number
26675|NCT01659853|Secondary|Onset of Action|Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application|30 minutes after baseline treatment application on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.||percentage of subjects|||Number
26676|NCT01659853|Primary|Composite Success|Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period|Hour 6 on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.||percentage of subjects|||Number
26677|NCT01659268|Primary|Time to Conclusion of Simulation Scenario (OSCE)|This result present the total time for execution of simulation scenario (OSCE) by the students.|10 minutes|||seconds||Standard Deviation|Mean
26678|NCT01659268|Secondary|Number of Attempts to Insertion of LMA|Number of attempts for insertion of LMA and obtainment of effective ventilation.|10 minutes (total time of scenario)|||attempts||Standard Deviation|Mean
26679|NCT01659268|Secondary|Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.|"Time of achievement to first effective ventilation and tidal volume (adequate chest expansion).~Stabilization of mannequin parameters (spO2 e HR)."|10 minutes (600 sec)|||seconds||Standard Deviation|Mean
26680|NCT01659268|Primary|Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).|"Score obtained in pre and post-test written, time to obtain the first effective ventilation (chest expansion through adequate ventilation on the mannequin), number of attempts to insert the LMA in the simulation scenario (OSCE).~Pre-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.~Post-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.~OSCE: instrument with total of 10 skills - each skill was subdivided in 4-5 activities (0.2-0.25 points each) - poor performance was score < 5.0; satisfactory performance 5.0-7.0; good 7.0-8.5 and excellent above 8.5 points."|Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes|The number of participants result of students that signed up in the workshop.||units on a scale||Standard Deviation|Mean
26681|NCT01659125|Primary|Responder Status|Participants who experienced a clinically significant change in Y-BOCS score defined as posttreatment YBOCS score that (a) has decreased by a reliable level (at least 1.96 times the standard deviation of that measure, taking into account the reliability of the measure itself; in this case, a decrease of 5 points or more), and (b) is within the nonclinical range of scores (in this case, a score of 13 or below).|Week 17 (post-treatment) and 6-month follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).||participants|||Number
26682|NCT01659125|Primary|Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions. The total score is reported here and ranges from 0 to 40 with higher scores indicating more severe OCD symptoms.|Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).||units on a scale||Standard Deviation|Mean
26683|NCT01658943|Other Pre-specified|Objective Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible and analyzable patients with measurable disease.||participants|||Number
26684|NCT01658943|Other Pre-specified|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.||months||95% Confidence Interval|Median
26685|NCT01658943|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.||months||95% Confidence Interval|Median
26686|NCT01658943|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
26687|NCT01658904|Secondary|Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT||Day 100 post-AHCT|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.|||||
26688|NCT01658904|Secondary|Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy||Post-AHCT following CFZ therapy|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.|||||
30296|NCT01600287|Secondary|Divergence|slope of the linear regression curve of performance error against time.|8 hours (approx)|||errors per second||Standard Deviation|Mean
26690|NCT01658904|Primary|Engraftment Failure Transplant Related Mortality|Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.|up to day 100|||participants|||Number
26691|NCT01658839|Primary|Half-life (t½)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||hours||Standard Deviation|Mean
26692|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||ng*hr/mL||Standard Deviation|Mean
26693|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||ng*hr/mL||Standard Deviation|Mean
26694|NCT01658839|Primary|Time to Last Measurable Concentration (Tlast)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||hours||Standard Deviation|Mean
26695|NCT01658839|Primary|Time to Reach Cmax (Tmax)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||hours||Standard Deviation|Mean
26696|NCT01658839|Primary|Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)|Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).||ng/mL||Standard Deviation|Mean
26697|NCT01658813|Secondary|Median Survival|Median survival was measured from date of entry on study until date of death|from time of study entry until death|all 18 patients were analyzed.||months||Full Range|Median
26698|NCT01658813|Secondary|Median Duration of Response|Responding patients were reevaluated with radiographic studies every 8 weeks after response was first documented. Standard RECIST response criterial were utlized.|Every 8 weeks|2 partial responses were seen.||months||Full Range|Median
26699|NCT01658813|Secondary|Response Rate|Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized.|8 weeks|||percentage of patients responding||95% Confidence Interval|Number
26700|NCT01658813|Secondary|Number of Responses|Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|measured every 8 weeks until disease progression or date of death from any cause, whichever came first, assessed up to 2 years.|||number of patients responding|||Number
26701|NCT01658813|Primary|Progression Free Survival|Progression Free Survival (PFS) was calculated as the time (months) from date of the start of treatment to the date of first observed disease progression (per standard Response Evaluation Criteria In Solid Tumors [RECIST] or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|measured until progression|||months||Full Range|Median
26702|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 12 Weeks|"Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 12|||units on a scale||95% Confidence Interval|Mean
26703|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 8 Weeks|"Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 8|||units on a scale||95% Confidence Interval|Mean
26704|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 4 Weeks|"Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 4|||units on a scale||95% Confidence Interval|Mean
26705|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 1 Week|"Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 1|||units on a scale||95% Confidence Interval|Mean
26706|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 12 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 12|||units on a scale||95% Confidence Interval|Mean
26707|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 8 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 8|||units on a scale||95% Confidence Interval|Mean
26708|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 4 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 4|||units on a scale||95% Confidence Interval|Mean
26709|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 1 Week|"Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|1 week|||units on a scale||95% Confidence Interval|Mean
26710|NCT01658657|Primary|Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic|At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.|4 months|6 participants withdrawn before study completion||participants|||Number
26711|NCT01658579|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Week 16|Safety population: all randomized participants who were exposed to at least one dose, regardless of amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
26712|NCT01658579|Secondary|Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Here n = participants with basal insulin dose assessment at specified time-point. Missing data imputed using LOCF.||U/kg||Standard Deviation|Mean
26713|NCT01658579|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16|Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.|Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 7-point SMPG assessment, n = participants with 7-point SMPG assessment at specified time. Missing data imputed using LOCF.||mmol/L||Standard Deviation|Mean
26714|NCT01658579|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 FPG assessment, n = participants with FPG assessment at specified time. Missing data imputed using LOCF.||mmol/L||Standard Deviation|Mean
26715|NCT01658579|Secondary|Change in HbA1c From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population: randomized participants who received at least 1 dose; had baseline, at least 1 post-baseline efficacy assessment; irrespective of compliance. Number of participants analyzed = participants with baseline, Week 8 and/or 16 HbA1c assessment, n = participants with HbA1c assessment at specified time. LOCF applied.||percentage of hemoglobin||Standard Deviation|Mean
26716|NCT01658579|Secondary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80–140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Weeks 7-8 in Period A and Weeks 15-16 in Period B|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment, and n = participants with assessment at specified time-point.||percentage of time||Standard Deviation|Mean
26717|NCT01658579|Secondary|Evaluation of Diurnal Glucose Exposure, Variability, and Stability|The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
26718|NCT01658579|Secondary|Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])|Percentage of time with glucose below the lower limit of glycemic range (<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.||percentage of time||Standard Error|Least Squares Mean
26719|NCT01658579|Secondary|Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])|Percentage of time with glucose above the upper limit of glycemic range (>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using last observation carried forward (LOCF).||percentage of time||Standard Error|Least Squares Mean
26720|NCT01658579|Primary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|Continuous glucose monitoring (CGM) population: All participants who received at least 1 dose, had evaluable post-baseline CGM data, irrespective of compliance. Number of participants analyzed = participants with baseline, Weeks 7-8 (Period A) and/or Weeks 15-16 (Period B) CGM assessment. Missing data imputed using last observation carried forward.||percentage of time||Standard Error|Least Squares Mean
26721|NCT01658514|Primary|Correlation of Placebo-adjusted Change From Pre-dose Value in Lactate Versus Metformin Concentration|To determine the exposure-response relationship of metformin and plasma lactate concentrations|from the time of dosing (0 h) to 24 hours postdose|PD Evaluable Population||R²|||Number
26722|NCT01658514|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the time of dosing (0 h) to the time of the last quantifiable metformin concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population||ng/mL||Standard Error|Least Squares Mean
26723|NCT01658514|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population||ng*h/mL||Standard Error|Least Squares Mean
26724|NCT01658436|Secondary|Stage 1 - Disease Control Rate|Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).||Percentage of participants||95% Confidence Interval|Number
26725|NCT01658436|Secondary|Stage 1- Overall Response Rate (ORR)|Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).||Percentage of participants|||Number
32661|NCT01560260|Primary|Response Rate (CR or PR) Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1||At 6 months|Thirteen patients were still receiving linsitinib at 6 months.||participants|||Number
26726|NCT01658436|Primary|Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review|PFS rate at 16 weeks was defined as a binary variable. Patients were considered as ‘progression free’ after 16 weeks if they had an overall lesion response of complete response (CR) partial response (‘PR) or stable disease (SD)’ and “progressed” if they had an overall lesion response of ‘Progressive disease (PD) at the scan which occurred on day 105 after start of treatment, or later. Patients whose 16 weeks tumor assessment was unknown, missing or outside the window was not considered as ‘progression free’ and was considered a “failure” and counted only in the denominator for the estimation of the 16 week progression free rate.|16 weeks after the first BEZ235 administration.|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).||Percentage of participants||95% Confidence Interval|Number
26727|NCT01658072|Primary|Time Until Patient is Ready for Discharge|"readiness for discharge to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty."|Length of Hospital Stay, an expected average of 3 days|||days||Standard Deviation|Mean
26728|NCT01658020|Secondary|Change in CAT Scores|"The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit.~CAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life.~CAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point.~The scores of each question item were summed into the total score, which had values between 0 and 40."|10 days|Per protocol population||scores on a scale||Standard Deviation|Mean
26729|NCT01658020|Secondary|Change in EXACT-PRO Score|"The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit.~EXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD.~EXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation."|10 days|Per protocol population||scores on a scale||Standard Deviation|Mean
26730|NCT01658020|Secondary|Microbiological Response Rate|"Microbiological response rate in the microbiological per protocol(PP) population.~Microbiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days|||Percentage of participants||95% Confidence Interval|Number
26731|NCT01658020|Secondary|Clinical Cure Rate in the Microbiological Per Protocol(PP) Population|"Clinical response corresponding clinical cure in the microbiological per-protocol population.~Microbiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days|||Percentage of participants||95% Confidence Interval|Number
26732|NCT01658020|Secondary|Clinical Response in the Clinical Population|Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|36days|Per protocol population||percentage of participants||95% Confidence Interval|Number
26733|NCT01658020|Primary|Clinical Response in the Clinical Populations|Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|10days|Per protocol population||percentage of participants||95% Confidence Interval|Number
26734|NCT01657903|Other Pre-specified|SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis.||Percentage SMH||Standard Error|Least Squares Mean
26735|NCT01657903|Other Pre-specified|RER of Enamel Specimens Post 2 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.||% RER||Standard Error|Least Squares Mean
26736|NCT01657903|Primary|Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.||Percentage SMH||Standard Error|Least Squares Mean
32686|NCT01559675|Secondary|Hemodynamic Instability||Through the end of hospitalization or 7 days postoperatively||||||
26737|NCT01657903|Primary|Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.||Percentage RER||Standard Error|Least Squares Mean
26738|NCT01657877|Primary|Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed.||Percentage SMHR||Standard Error|Mean
26739|NCT01657877|Secondary|Enamel Fluoride Uptake (EFU)|Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.|Baseline to 21 days|PP population: all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.||ppm EFU||Standard Error|Mean
26740|NCT01657877|Secondary|Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses.||Percentage SMHR||Standard Error|Mean
26741|NCT01657370|Other Pre-specified|Plasma MK-1602 Concentrations at Visit 2 (Day 4)||Up to 3.5 hours post dose 3|As per protocol, only listings of individual plasma concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.|||||
26742|NCT01657370|Other Pre-specified|Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)||3.5 hours post dose 3|As per protocol, only listings of individual DBS concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.|||||
26743|NCT01657370|Other Pre-specified|Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day||Up to 24 hours post dose 1|As per protocol, only listings of individual DBS for MK-1602 over time were produced. No formal non-compartmental Pharmacokinetic (PK) analysis was done for this outcome measure.|||||
26744|NCT01657370|Secondary|Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day|TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26745|NCT01657370|Secondary|Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day|TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26746|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26747|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26748|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day||2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26749|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day|Photophobia is sensitivity to light.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
32687|NCT01559675|Primary|Orthostatic Hypotension||Postoperative Day 1|||participants|||Number
26751|NCT01657370|Primary|Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day|PR was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26752|NCT01657370|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day|PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.||percentage of participants||95% Confidence Interval|Number
26753|NCT01657370|Primary|Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day|The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay.|2 hours post dose 1|Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis.||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
26754|NCT01657292|Secondary|Assessment of Adverse Events||2 to 3 weeks||||||
26755|NCT01657292|Secondary|Microbial Colonization of the Wound Halves||2 to 3 weeks||||||
26756|NCT01657292|Secondary|PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples||2 to 3 weeks||||||
26757|NCT01657292|Secondary|Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks||||||
26758|NCT01657292|Secondary|Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation||3 and 12 months||||||
26759|NCT01657292|Secondary|Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks||||||
26760|NCT01657292|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator||2 to 3 weeks||||||
26761|NCT01657292|Secondary|Percentage of Patients With Wound Closure at Different Time Points||2 to 3 weeks||||||
26762|NCT01657292|Secondary|Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care||2 to 3 weeks||||||
26763|NCT01657292|Secondary|Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care||2 to 3 weeks||||||
26764|NCT01657292|Primary|Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care|Photo-based evaluation by independent experts blinded to the treatment regime.|2 to 3 weeks|The analysis included all patients who were treated at least once with Oleogel-S10 or Octenilin® wound gel (as randomised) and for whom a difference in wound healing between the treatment was observed.||percentage of patients||95% Confidence Interval|Number
26765|NCT01657032|Secondary|Duration of Intravenous Therapy|need for intravenous rehydration therapy (how long if needed)|7days|||days||Inter-Quartile Range|Median
26766|NCT01657032|Secondary|Need for Intravenous Therapy|need for intravenous rehydration therapy (yes/no)|yes/no, for 7days|||participants|||Number
26767|NCT01657032|Secondary|Need for Hospitalization|If the child need to hospitalized|7 days|||participants|||Number
26768|NCT01657032|Secondary|Tolerance of Products|tolerance of products (whether the child took medicaments),|7days|||participants|||Number
26769|NCT01657032|Secondary|Diarrhea Recurrence|If the was a diarrhea recurrence during 7days|7 days|||participants|||Number
26770|NCT01657032|Secondary|Vomiting|How many times the child was vomiting (during the study)|how many times for 7days|||vomiting episodes||Inter-Quartile Range|Median
26771|NCT01657032|Secondary|Vomiting|If the child vomiting after randomization (yes/no)|yes/no, for 7days|||participants|||Number
26772|NCT01657032|Secondary|Need for Antibiotic Therapy,|need for antibiotic therapy because of diarrhea|yes/no, for 7days|||participants|||Number
26773|NCT01657032|Secondary|Consistency of Stools|"consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories.~Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1–2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea."|day 4-th|||Units on a scale||Inter-Quartile Range|Median
26774|NCT01657032|Secondary|Frequency of Loose Stools,|number of loose stools during 7 days|number of loose stools during 7 days|||number of loose stools during 7days||Inter-Quartile Range|Median
26775|NCT01657032|Primary|Duration of Diarrhea|The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).|counted in days during 7days|||days||Inter-Quartile Range|Median
27573|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
26776|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
26777|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
26778|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
26779|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
26780|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants at ET|||Number
26781|NCT01657019|Secondary|Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)|The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline.|Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||units on a scale||Standard Deviation|Mean
26924|NCT01656031|Primary|Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML|Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.|5 weeks|||participants|||Number
26782|NCT01657019|Secondary|Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale|The CGI rating scales permitted the global evaluation of a participant’s condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant’s condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a ‘not assessed’ option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation.|Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants||95% Confidence Interval|Number
26783|NCT01657019|Primary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were “yes,” the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were “no,” then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|53 weeks|The Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||participants|||Number
26784|NCT01657019|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety||52 weeks|The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.||percentage of participants|||Number
26785|NCT01656967|Other Pre-specified|Orolaryngeal Pressure|The oropharyngeal leak pressure (OLP) was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and noting the airway pressure at which equilibrium was reached (not permitted to exceed 40 cm H2O).|Following SGA Insertion|||mmHg||Inter-Quartile Range|Median
26786|NCT01656967|Secondary|Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Approximately 1-2 hours after entering the PACU||||||
26787|NCT01656967|Secondary|Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Within 30 minutes of completion of surgery||||||
26788|NCT01656967|Secondary|Number of Participants With Overall Intubation Success|Ease of ETT insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At ETT insertion|||participant|||Number
26789|NCT01656967|Secondary|Number of Participants With Overall Success for SGA Placement|Ease of SGA insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At SGA insertion|||participants|||Number
26790|NCT01656967|Secondary|Number of Participants in Whom ETT Insertion Was Successful on the First Attempt||At ETT insertion|||participants|||Number
26791|NCT01656967|Secondary|Number of Participants in Whom SGA Insertion Was Successful on the First Attempt||At SGA insertion|||participants|||Number
26792|NCT01656967|Secondary|Time for Endotracheal Tube (ETT) Insertion|After the SGA is inserted, time for intubation will be recorded. Time for ETT insertion was measured, for arm 1, from when the AMBU aScope is at the connector level of the Aura-I or, for arm 2, from when the ETT is at the connector level of the Intubating LMA to first detection of CO2 on the capnogram. The AScope 2 disposable fiberoptic camera will be used to assist with intubation for Group 1 patients. Group 2 patients will be intubated using the LMA-Fastrach EndoTracheal Tube.|At ETT insertion|||seconds||Inter-Quartile Range|Median
26793|NCT01656967|Secondary|Time for Supraglottic Airway (SGA) Insertion|Time for SGA insertion was measured from when the tip of the cuff was at the mouth to detection of CO2 on the capnogram.|At SGA insertion|||seconds||Inter-Quartile Range|Median
26794|NCT01656967|Primary|Total Intubation Time|Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.|Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion|||seconds||Inter-Quartile Range|Median
26795|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using a Kaplan-Meier Survival Analysis, with significance being at P < 0.05.||days to wound closure||Full Range|Median
26796|NCT01656889|Secondary|Change in Target Ulcer Pain|Target ulcer pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over 12 week treament period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||units on a scale||Standard Error|Least Squares Mean
26925|NCT01655498|Secondary|Device-related Adverse Events|The number of overall adverse events rated as probably or definitely related to the study device.|1month|All subjects who were exposed to the VBC device (now called Eclipse) during the Treatment Period.||events|||Number
26797|NCT01656889|Secondary|Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over the 12 week treatment period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||units on a scale||Standard Error|Least Squares Mean
26798|NCT01656889|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two and three months following initial ulcer closure.|"The 285 subjects (HP802-247: 141/222; Vehicle: 144/225) who completed the treatment period with confirmed wound closure.~Subjects returning for Visit 1 with confirmed wound closure at end of treatment: 134 HP802-247 and 132 Vehicle.~Subjects returning for Visit 2 with confirmed wound closure at end of treatment: 132 HP802-247 and 131 Vehicle"||participants|||Number
26799|NCT01656889|Secondary|Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05||percentage of Closed Ulcers|||Number
26800|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05 and by the Kaplan-Meier survival procedure||days||Full Range|Median
26801|NCT01656889|Primary|Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05||participants|||Number
26802|NCT01656850|Primary|Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||μmol/L||Standard Deviation|Mean
26803|NCT01656850|Primary|Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||ng/mg creatinine||Standard Deviation|Mean
26804|NCT01656850|Primary|Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||U/L||Standard Deviation|Mean
26805|NCT01656850|Primary|Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||nmol/mg||Standard Deviation|Mean
26806|NCT01656850|Primary|Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||ng/mL||Standard Deviation|Mean
26807|NCT01656850|Primary|Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||μmol/L||Standard Deviation|Mean
26808|NCT01656850|Primary|Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||g/L||Standard Deviation|Mean
26809|NCT01656850|Primary|HOMA at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||pg/mL||Standard Deviation|Mean
26810|NCT01656850|Primary|Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||percentage of hemoglubin||Standard Deviation|Mean
26811|NCT01656850|Primary|Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mU.min/L||Standard Deviation|Mean
26812|NCT01656850|Primary|Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mU/L||Standard Deviation|Mean
26813|NCT01656850|Primary|Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mg.min/dL||Standard Deviation|Mean
26814|NCT01656850|Primary|Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mg/dL||Standard Deviation|Mean
26815|NCT01656850|Primary|Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||mmHg||Standard Deviation|Mean
26816|NCT01656850|Primary|Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||percentage of body weight||Standard Deviation|Mean
26817|NCT01656850|Primary|Body Weight at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention|||kg||Standard Deviation|Mean
26818|NCT01656850|Primary|Lipid Composition of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months|||g||Standard Deviation|Mean
26819|NCT01656850|Primary|The Calories of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months|||kcal||Standard Deviation|Mean
26822|NCT01656772|Primary|Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.|The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.|7 days Follow-up|||participants|||Number
26823|NCT01656772|Primary|The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.|Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.|Peri-procedural|All adverse events reported by the sites were independently adjudicated by the data safety monitory, DSM.||Pulmonary Veins|Participants||Number
26824|NCT01656759|Secondary|Postoperative Blood Loss|Measured as drainage output from postoperative drains during hospitalization.|3 days|||mL||Standard Deviation|Mean
26825|NCT01656759|Secondary|Total Transfusions|The number of transfusions each patient receives during their postoperative hospitalization.|3 days|||Number of transfusions|||Number
26826|NCT01656759|Primary|Total Blood Loss|Combination of intraoperative and postoperative blood loss for participants.|Collected during surgery and in first 2-3 days after surgery|||mL||Standard Deviation|Mean
26827|NCT01656759|Primary|Primary--Percent Change of Pre- to Post-Operative Hemoglobin|Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.|Pre-operative to 1 month|||Percent Change||Standard Deviation|Mean
26828|NCT01656486|Primary|Decreased Secretions|Measurement of pancreatic panel, decreased Pancreatic Secretions|1 year|||participants|||Number
26829|NCT01656460|Primary|Early and Intermediate Toxicity for Dose Limiting Toxicity|"Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT.~DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT."|3 months|||participants|||Number
26830|NCT01656434|Secondary|Change From Baseline in Body Weight|Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.|Baseline and Week 52|Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint.||kilograms||Standard Error|Mean
26831|NCT01656434|Secondary|Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event||Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.||Participants|||Number
26832|NCT01656434|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.||Percentage of Participants|||Number
26833|NCT01656434|Secondary|Percentage of Participants With an Absence of Withdrawal Bleeding|Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.|||||
26834|NCT01656434|Secondary|Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING."|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.|||||
26835|NCT01656434|Primary|Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.|Up to 1 year (13 cycles)|Planned analysis for this primary endpoint was not performed due to early study termination.|||||
26836|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26837|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26838|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mmHg||Standard Error|Least Squares Mean
26839|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
26840|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26841|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26842|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26869|NCT01656408|Primary|Tmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
26926|NCT01655498|Secondary|Number of Incontinent Days|Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period|1 Month|||days||Standard Deviation|Mean
26843|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of pulse pressure||Standard Error|Least Squares Mean
26844|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26845|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26846|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26847|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
26848|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26870|NCT01656408|Primary|Cmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
26849|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26850|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26851|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
26852|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26853|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26854|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26871|NCT01656408|Primary|AUC0-24 of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
26927|NCT01655498|Primary|Frequency of FI Episodes|Subjects with at least a 50% reduction in FI episodes (major or minor soiling)|1 Month|Subjects who were successfully fit with the VBC device.||percentage of participants|||Number
26855|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
26856|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26857|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26858|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26859|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
26860|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26913|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Concentration 0 Hour||Days 1-169 and Days 169-337|Participants in the PK/PD subset with a measured value.||ng/mL||95% Confidence Interval|Geometric Mean
26914|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Cmax||Days 1-169 and Days 169-337|||ng/mL||95% Confidence Interval|Geometric Mean
26861|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26862|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26863|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||percentage of central pulse pressure||Standard Error|Least Squares Mean
26864|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
26865|NCT01656408|Primary|Tmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||hr||Full Range|Median
26866|NCT01656408|Primary|Cmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
26867|NCT01656408|Primary|AUC0-24 of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
26868|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
26915|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)||Days 1-169 and Days 169-337|||days * ng/mL||95% Confidence Interval|Geometric Mean
26992|NCT01654276|Primary|Serum HDL-cholesterol||6 months|||mg/dl||Standard Deviation|Mean
26872|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
26873|NCT01656408|Primary|Tmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
26874|NCT01656408|Primary|Cmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
26875|NCT01656408|Primary|AUC0-24 of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
26876|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 15.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
26877|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
26878|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
26879|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 6 and Day 15 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
26880|NCT01656408|Primary|t1/2 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the Day 1 dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
26881|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
26882|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
26916|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Castration (Tcast)||Days 1-169|||days||95% Confidence Interval|Geometric Mean
26917|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)||Days 1-169|PK/PD subset of 15 participants||hours||95% Confidence Interval|Median
26993|NCT01654276|Primary|Seum Total Cholesterol||6 months|||mg/dl||Standard Deviation|Mean
26883|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
26884|NCT01656408|Primary|Apparent Terminal Half-life (t1/2) of MK-8150 Determined Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Geometric Coefficient of Variation|Geometric Mean
26885|NCT01656408|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||hr||Full Range|Median
26886|NCT01656408|Primary|Maximum Observed Plasma Concentration (Cmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM||Geometric Coefficient of Variation|Geometric Mean
26887|NCT01656408|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||μM*hr||Geometric Coefficient of Variation|Geometric Mean
26888|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
26889|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26890|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
26891|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26892|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
26893|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26894|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
26895|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26896|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
26897|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26898|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
26899|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26900|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||beats per minute||Standard Error|Least Squares Mean
26901|NCT01656408|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure||mm Hg||Standard Error|Least Squares Mean
26902|NCT01656408|Primary|Number of Participants Discontinued From Study Drug Due to Meeting Hemodynamic Stopping Rules|Hemodynamic criteria for stopping drug dosing were applied (any of the following, obtained resting and if present for ≥1 hour, unless noted). For all Panels: HR >120 bpm; SBP ≥180 mm Hg (Panels A-D/G-J) and ≥175 mm Hg (Panels E-F); DBP ≥110 mm Hg; DBP <50 mm Hg; SBP <90 mm Hg or participant placed in Trendelenburg position. For Panels A-H: HR increase over identified baseline of ≥25 beats per minute; SBP reduction >30 mm Hg versus identified baseline; >20 mm Hg drop in SBP and >20 beats per minute rise in HR observed together versus identified baselines; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. For Panels I-J, any of the following-down dosing criteria if still present 24 hours after dose decrease: HR increase ≥20 beats per minute versus identified baseline; SBP reduction >30 mm Hg versus identified baseline; SBP <100 mm Hg; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together.|Up to 28 days|All participants who received at least one dose of study drug||participants|||Number
26903|NCT01656408|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. The 8 crossover Panel H participants are represented in both Panel H – MK-8150 10/20 mg column and Placebo (Panel A - J) column.|Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period)|All participants who received at least one dose of study drug||participants|||Number
26904|NCT01656304|Secondary|Correlation of Urine NTX and Serum BSAP Levels With Time to PSA Progression||Baseline, week 7 or 12 and post-therapy||||||
26905|NCT01656304|Secondary|Changes in Levels of N Terminal Collagen Peptide and Bone-specific Alkaline Phosphatase With Bevacizumab Therapy||Baseline, week 7 or 12, and post-therapy||||||
26906|NCT01656304|Secondary|Circulating Tumor Cell Count||Baseline, at week 12||||||
26907|NCT01656304|Secondary|Time to Distant Metastatic Disease||Every 3 months||||||
26908|NCT01656304|Secondary|The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer||Baseline, every 6 weeks while on therapy, and then every 3 months thereafter||||||
26909|NCT01656304|Secondary|Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab||Every 3 months||||||
26910|NCT01656304|Primary|Time to PSA Progression (TTPP)|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.|An average every 6 weeks for up to 3 months|||months||90% Confidence Interval|Median
26911|NCT01656304|Primary|Toxicities Associated With Bevacizumab Therapy|Toxicity rates will be summarized by point estimates and Wilson type 80% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.|An average of every 2 weeks while on therapy|||participants|||Number
26912|NCT01656304|Primary|PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer|Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.|An average every 6 weeks for up to 3 months|||participants|||Number
26928|NCT01655381|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI|"Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22.~HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||percentage of participants|||Number
26929|NCT01655381|Secondary|Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission|"HAQ-DI remission was defined as HAQ-DI score <0.5.~HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||percentage of participants|||Number
26930|NCT01655381|Secondary|Physicians’ Global Assessment of Disease Activity (VAS) Score|The physicians’ global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Full Range|Median
26931|NCT01655381|Secondary|Participants’ Global Assessment of Disease Activity (VAS) Score|The participants’ global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Full Range|Median
26932|NCT01655381|Secondary|Participants’ Global Assessment of Pain (VAS) Score|The participants’ global assessment of pain (VAS) was assessed using a 100-mm horizontal VAS with 0=no pain to 100=maximum pain.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Full Range|Median
26933|NCT01655381|Secondary|C-reactive Protein (CRP) Level|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5 milligrams per liter (mg/L). Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||mg/L||Full Range|Median
26934|NCT01655381|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||mm/hour||Full Range|Median
26935|NCT01655381|Secondary|Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time|The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 swollen joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||swollen joints||Standard Deviation|Mean
26936|NCT01655381|Secondary|Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time|The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 tender joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||tender joints||Standard Deviation|Mean
26937|NCT01655381|Secondary|Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time|SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), and the patient’s global assessment of disease activity and physician’s global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Standard Deviation|Mean
26938|NCT01655381|Secondary|Change From Day 1 in DAS28-ESR Scores Over Time|DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient’s global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.||units on a scale||Standard Deviation|Mean
26939|NCT01655381|Secondary|Time to RA Flare Following Remission or Drug-Free Remission|Time to RA flare was defined as period of clinical remission or drug-free remission followed by flare of DAS28-ESR (increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2). In the case of several remission periods for the same participant, the largest period was used.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||days||Full Range|Median
26940|NCT01655381|Secondary|Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare|An RA flare was defined as an increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||percentage of participants|||Number
26941|NCT01655381|Secondary|Cumulative Time of Remission Per Participant Over the Extension Study Period|Clinical remission was defined as DAS28-ESR <2.6 and/or SDAI ≤3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||days||Full Range|Median
26942|NCT01655381|Secondary|Percentage of Participants With at Least One Drug-Free Period|Drug-free remission period was defined as clinical remission for at least 2 consecutive assessment visits (every 12 weeks) AND without tocilizumab administration during this clinical remission period.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||percentage of participants|||Number
26943|NCT01655381|Secondary|Percentage of Participants With at Least One Clinical Remission Period|Clinical remission: Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) less than (<)2.6 and/or Simplified Disease Activity Index (SDAI) less than or equal to (≤)3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient’s global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0-10, with higher scores corresponding to greater disease activity. SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), the patient’s global assessment of disease activity and physician’s global assessment of disease activity; SDAI scores range from 0-86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.||percentage of participants|||Number
26944|NCT01655381|Primary|Percentage of Participants With Any Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator’s judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant.|Up to 160 weeks|Safety population is defined as all included participants who received having at least one tocilizumab administration.||percentage of participants|||Number
26945|NCT01655329|Other Pre-specified|Likert-Like|Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image.|10 minutes|All 10 radiologist participants participated||units on a scale||Standard Deviation|Mean
26946|NCT01655329|Primary|Accuracy in Detecting the Tips of Tubes, Lines, and Wires.|Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology.|8 hours|||centimeters||Standard Error|Mean
26947|NCT01655329|Primary|Time for Completion of Tasks|Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time.|8 hours|Each radiologist interpreted only half (158) chest radiographs. All of the radiographs were interpreted by a combination of the 10 radiologist participants.||seconds|Participants|Standard Error|Mean
26948|NCT01655043|Secondary|Coronary Blood Volume Calculation Using MRI Stress Perfusion|The investigators anticipate that CBV changes (in ml/100g of tissue) under stress reflect complementary physiologic feed back to stress perfusion scans, contrary to the hypothesis by many groups who claim that cardiac BOLD and/or rest-perfusion scans can determine without recourse to exercise or pharmacological stress.|18 months||||||
26949|NCT01655043|Primary|Quantification of Myocardial Blood Volume|The investigators anticipated that a novel MRI imaging protocol using a high relaxivity blood-pool contrast agent (gadofosveset trisodium) would be capable of quantifying coronary flow reserve based on quantification of myocardial blood volume and would be correlated with myocardial flow reserve as measured in low spatial resolution nuclear SPECT scans. Pre- and post- gadofosveset trisodium images were to be used to calculate the myocardial blood volume. Myocardial blood volume is derived from an equation of the relaxation times of hydrogen atoms in the blood and myocardium. If the agent administered did not behave as a true intravascular agent in the myocardium, quantification of myocardial intravascular blood volume (and hence a calculated coronary flow reserve) could not be calculated using the specified approach. In this case, relaxation times would be reported. Relaxation (R) times are measured in inverse seconds.|outcome measured following single MRI scan|||seconds^-1||Standard Deviation|Mean
26950|NCT01654861|Secondary|Anti-Tumor Response|CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).|Every 2 months for up to 6 months.|Data were not analyzed as the study was prematurely closed.|||||
26951|NCT01654861|Primary|Adverse Events as a Measure of Safety and Tolerability|Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.|Weekly for up to 6 months.|||participants|Participants||Number
26952|NCT01654666|Secondary|Serum S-100B Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||pg/mL||Standard Deviation|Mean
26953|NCT01654666|Secondary|Serum Neuron Specific Enolase (NSE) Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||ng/L||Standard Deviation|Mean
26954|NCT01654666|Secondary|Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.|The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.|From baseline to 6 months after treatment.|||participants|||Number
26955|NCT01654666|Secondary|Serum High-sensitive C-reactive Protein (Hs-CRP).||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||mg/L||Inter-Quartile Range|Median
26956|NCT01654666|Primary|Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.||Within 48 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.||participants|||Number
26957|NCT01654666|Primary|Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.|Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.|Within six months after carotid artery stenting|The analysis population only included participants who fully completed the study.||participants|||Number
26958|NCT01654601|Secondary|Accumulation Rate of Clozapine in Plasma||Up tp 12hours|||ng/ml/hr||Standard Deviation|Mean
26959|NCT01654601|Secondary|Terminal Half Life of Clozapine in Plasma||Up to 12hours|||hour||Standard Deviation|Mean
26960|NCT01654601|Secondary|Time to Reach Maximum Concentration of Clozapine in Plasma||Up to 12hours|||hour||Standard Deviation|Mean
26961|NCT01654601|Primary|Maximum Concentration of Clozapine in Plasma||Up to 12hours|||ng/mL||Standard Deviation|Mean
26962|NCT01654549|Secondary|Anthropometric Measurements|Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study|8 weeks||||||
26963|NCT01654549|Secondary|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)|Secondary outcome measure was change in HOMA-IR from baseline to the end of study|8 weeks||||||
26964|NCT01654549|Secondary|Serum Lipid Profile|Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study|8 weeks||||||
26965|NCT01654549|Secondary|Fasting Serum Glucose|Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study|8 weeks||||||
26966|NCT01654549|Secondary|Serum Aspartate Aminotransferase Level|Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study|8 weeks||||||
26967|NCT01654549|Secondary|Serum Alanine Aminotransferase Level|Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study|8 weeks||||||
26968|NCT01654549|Primary|Liver Fat Content|"Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment).~The percent of liver fat was calculated as below:~“Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) – 0.454 * log (AST/ALT)”"|8 weeks (6 weeks post-treatment)|||percentage of liver fat content||Standard Deviation|Mean
26969|NCT01654536|Secondary|Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
26970|NCT01654536|Secondary|Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
26971|NCT01654536|Secondary|Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of partcipants|||Number
26994|NCT01654276|Primary|Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)||6 months|||Homeostatic model assessment for Insulin||Standard Deviation|Mean
26995|NCT01654276|Primary|Serum Insulin||6 months|||mU/L||Standard Deviation|Mean
26996|NCT01654276|Primary|Serum Glucose||6 months|||mg/dl||Standard Deviation|Mean
26972|NCT01654536|Secondary|Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
26973|NCT01654536|Secondary|Percentage of Subjects With Development of or Worsening in Lens Opacities.||0-6 months|||percentage of participants|||Number
26974|NCT01654536|Secondary|Number of Subjects With Development of or Worsening in Lens Opacities.||0-6 months|||participants|||Number
26975|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
26976|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
26977|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
26978|NCT01654536|Primary|The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
26979|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
26980|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
26981|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
26982|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||percentage of participants|||Number
26983|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
26984|NCT01654536|Primary|The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.||participants|||Number
26985|NCT01654523|Primary|Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment|Measures severity of trichotillomania. Total score ranges from 0 (none) to 28 (severe). Mean change is determined by score at baseline minus score after treatment.|Baseline to post treatment; typically over 9 weeks|||Units on a scale||Standard Deviation|Mean
26986|NCT01654302|Primary|Index Knee Pain Scores on a Numeric Rating Scale (NRS)|Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.|5 minutes after stopped exercise, performed 1 hour after intervention (patch application)|Of the 40 subjects 2 were lost to follow-up, one from each group, making a total of 38 participants included in the analysis. Unfortunately, NRS data at 5 minutes post-exercise is missing for 2 subjects in the Synera treatment group and 1 subject in the Placebo group due to technical errors. The data was captured but we were unable to retrieve it.||units on a scale||Standard Deviation|Mean
26987|NCT01654276|Primary|Urine pH||6 months|||pH||Standard Deviation|Mean
26988|NCT01654276|Primary|Fractional Excretion UA||6 months|||mg/mg||Standard Deviation|Mean
26989|NCT01654276|Primary|Urine Creatinine||6 months|||mg/dl||Standard Deviation|Mean
26990|NCT01654276|Primary|Urine Uric Acid||6 months|||mg/dl||Standard Deviation|Mean
26991|NCT01654276|Primary|Serum Triglycerides||6 months|||mg/dl||Standard Deviation|Mean
27002|NCT01654263|Secondary|Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.|Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 180 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.||Titer||95% Confidence Interval|Geometric Mean
27003|NCT01654263|Primary|Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.|Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 28 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.||Titer||95% Confidence Interval|Geometric Mean
27004|NCT01654263|Primary|Number of Participants Reporting Vaccine-related Serious Adverse Events.|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 180 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.||participants|||Number
27005|NCT01654263|Primary|Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.|"Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 28 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.||participants|||Number
27006|NCT01654263|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events|Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is >0mm.|Days 0 to Day 7 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.||participants|||Number
27007|NCT01654250|Other Pre-specified|Conners Parent Rating Scale (CPRS) Scores|CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
27008|NCT01654250|Other Pre-specified|Clinical Global Impression-Improvement (CGI-I)|The CGI-I measured the participant’s disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
27009|NCT01654250|Other Pre-specified|Clinical Global Impression of Severity (CGI-S)|CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant’s current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
27010|NCT01654250|Secondary|Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant’s performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 and 13 post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
27011|NCT01654250|Secondary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
27012|NCT01654250|Secondary|Onset and Duration of Clinical Effect|Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to [=<] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
27013|NCT01654250|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points|The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.|0.75 up to 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Least Squares Mean
27014|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|Day 0|||titers||95% Confidence Interval|Geometric Mean
27015|NCT01654224|Secondary|Non-inferiority and Immunoprotection Persistence at 6 Months|Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents|6 months|The above numbers reflect the participants with data available at 6 months. Eleven subjects (five in the high dose and 6 in the standard dose groups) died of non-related causes. Some of the samples were insufficient or unable to be collected.||Titers||90% Confidence Interval|Geometric Mean
27016|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|30 days|||titers||95% Confidence Interval|Geometric Mean
27017|NCT01654107|Primary|7-day Point Prevalence Abstinence|3-months after the Quit Date|3-months|||participants|||Number
27018|NCT01653782|Secondary|Cost Effectiveness|Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.|6 months, 12 months||||||
27019|NCT01653782|Primary|Number of Days on Sick Leave|Sick leave using self-reported data on number of days on sick leave|12 MONTHS|by a power calculation based on estimates of change in the primary outcome variables from earlier studies||Days||Standard Deviation|Mean
27020|NCT01653743|Secondary|Percentage of Participants With Clinical Pregnancy|Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
27021|NCT01653743|Secondary|Percentage of Participants With Biochemical Pregnancy|Percentage of subjects with biochemical pregnancy was assessed. Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS on the Day 35 to 42 post hCG treatment, but with a positive serum β-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than [>] 10 IU/Liter)|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
27022|NCT01653743|Secondary|Mid-luteal Endometrial Thickness|Endometrial thickness was measured using TVUS.|Day 5 to 7 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||millimeter||Standard Deviation|Mean
27023|NCT01653743|Secondary|Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 9.4 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
27024|NCT01653743|Primary|Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The modified intent to treat (Mod ITT) population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.||percentage of subjects||95% Confidence Interval|Number
27025|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 10|Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time.|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in the number of participants analyzed for each end point, as represented by n."||Units on a scale||Standard Deviation|Mean
27026|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 5|Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time.|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."||Units on a scale||Standard Deviation|Mean
27027|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 10|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:~Today my sore felt completely protected~Today my cold sores interfered with facial movements such as smiling, eating or drinking~Today my cold sores interfered with my interaction with other people~Today the patch disguised my cold sores~Today I was bothered by the appearance of my cold sores~Today my patch was easy to apply~Today the patch covering my cold sores was bothersome~Today the patches stayed in place on my cold sores until I removed them~Today the patches were easy to remove from my lip or skin"|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."||Units on a scale||Standard Deviation|Mean
27028|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 5|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:~Today my sore felt completely protected~Today my cold sores interfered with facial movements such as smiling, eating or drinking~Today my cold sores interfered with my interaction with other people~Today the patch disguised my cold sores~Today I was bothered by the appearance of my cold sores~Today my patch was easy to apply~Today the patch covering my cold sores was bothersome~Today the patches stayed in place on my cold sores until I removed them~Today the patches were easy to remove from my lip or skin"|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and had at least one post-baseline efficacy measurement. There were difference in number of participants analyzed for each end point as represented by n."||Units on a scale||Standard Deviation|Mean
27029|NCT01653509|Primary|Mean Change From Baseline in Color Intensity of Lesions|The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity).|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.||Units on a scale||Standard Error|Least Squares Mean
27030|NCT01653509|Primary|Mean Change From Baseline in Temperature|Lesion thermographic parameters for TEV and MEV were analysed.|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.||Degree celsius||Standard Error|Least Squares Mean
27031|NCT01653509|Primary|Mean Change From Baseline in Blood Flow|"Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique.~Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days."|Baseline to Day 10|Intent to Treat (ITT) population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.||Perfusion Units||Standard Error|Least Squares Mean
27032|NCT01653418|Secondary|Time to Platelet Engraftment After V-BEAM.|Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at > 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||days||Full Range|Median
27033|NCT01653418|Secondary|Treatment Related Mortality (TRM) of V-BEAM||Day +100|||participants|||Number
27034|NCT01653418|Secondary|Number of Participants With Overall Survival (OS)|OS is defined as the duration from the time of transplant to death or last follow-up.|Median follow-up of 6 months (range: 6-12 months)|||participants|||Number
27035|NCT01653418|Secondary|Time to Neutrophil Engraftment After V-BEAM.|Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC > 0.5x109/L post transplant when it is sustained for more than three consecutive days.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||days||Full Range|Median
27036|NCT01653418|Secondary|Toxicity of V-BEAM|"Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.~Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.~This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details."|30 days after end of treatment / Day +100|||participants|||Number
27037|NCT01653418|Secondary|Very Good Partial Response Rate (VGPR+nCR+sCR+CR)|Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
27038|NCT01653418|Secondary|Overall Response Rate (ORR)|"ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR)~Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|3 months following Day +100 visit|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
27039|NCT01653418|Secondary|Number of Participants With Progression-free Survival (PFS)|"PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.~Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|Median follow-up of 6 months (range: 6.0-12.0 months)|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
27040|NCT01653418|Primary|Complete Response Rate (Complete Response + Stringent Complete Response)|Defined by the International Myeloma Working Group (IMWG) criteria|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.||participants|||Number
27041|NCT01653262|Secondary|Generalized Seizure Days Over the Treatment Period for Subjects With Idiopathic Generalized Epilepsy|"Generalized seizure days are standardized to a 28-day duration and changes in generalized seizure days are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).~Generalized seizures (Type II) include the following seizure types:~Absence (IIA1)~Atypical absence (IIA2)~Myoclonic (IIB)~Clonic (IIC)~Tonic (IID)~Tonic-clonic (IIE)~Atonic (IIF)~A specific effect of BRV on the occurrence of generalized seizures was not assessed."|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|This variable was not analyzed and no results are available.|||||
27042|NCT01653262|Secondary|Partial Onset Seizure (POS) Frequency Over the Treatment Period for Subjects With Focal Epilepsy|"The POS frequency is standardized to a 28-day duration and changes in POS frequency are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures (IA)~Complex partial seizures (IB)~Partial seizures evolving to secondarily generalized seizures (IC)"|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Efficacy Analysis Set (EAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline day of seizure daily record card (subject diary card).||partial onset seizures||Inter-Quartile Range|Median
27043|NCT01653262|Secondary|Occurrence of Serious Adverse Events During the Study Period|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.||events|||Number
27044|NCT01653262|Secondary|Withdrawal Due to an Adverse Event (AE) During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.||subjects|||Number
27045|NCT01653262|Secondary|Incidence of Treatment Emergent Adverse Events During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment emergent AE is any event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.||events|||Number
27046|NCT01653262|Secondary|Number of Subjects Who Are Free From Nonpsychotic Behavioral Side Effects Over the Entire Treatment Period|Nonpsychotic behavioral side effects (NBSE) include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Visit 2 (Week 0) to Visit 6 (Week 12)|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
27047|NCT01653262|Secondary|Number of Subjects Who Have a Complete Abatement of Nonpsychotic Behavioral Side Effects for the Last Assessment During the Treatment Period, Based on the Investigator's Overall Assessment|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
27083|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||hr||Standard Deviation|Mean
27048|NCT01653262|Secondary|Change From Study Entry in Nonpsychotic Behavioral Side Effects to the End of the Treatment Period/Early Discontinuation Visit, Measured by Means of the Investigator Global Evaluation of Nonpsychotic Behavioral Side Effects (I-GEBSE) Scale|"There are seven levels for the I-GEBSE:~Marked improvement~Moderate improvement~Slight improvement~No change~Slight worsening~Moderate worsening~Marked worsening"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
27049|NCT01653262|Secondary|Shift in the Maximum Intensity From Baseline to the End of the Treatment Period for Side Effects Primarily Associated With Discontinuation of Levetiracetam (LEV) as Determined by the Investigator|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||subjects|||Number
27050|NCT01653262|Primary|Percentage of Subjects Who Achieved a Clinically Meaningful Reduction of Nonpsychotic Behavioral Side Effects Based on the Investigator's Overall Assessment From Study Entry to the End of the Treatment Period|"Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.~The Investigator completed the assessment by answering the following:~“Has there been a clinically meaningful reduction of nonpsychotic behavioral side effects since the start of BRV?”~- Yes/No"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.||percentage of subjects|||Number
27051|NCT01653158|Secondary|Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.|Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.|||||
27052|NCT01653158|Secondary|Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4|Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.|Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort.||mg/L||Standard Deviation|Mean
27053|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.|||||
27054|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.|||||
27055|NCT01653158|Secondary|Observed Accumulation Ratio (Rac) of CP-751,871|AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1|30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||Ratio||Standard Deviation|Mean
27056|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
27057|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported because it is the same as Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) in Cycle 1 (OM 23), for both represented the planned 21-day dosing interval.|||||
27058|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.|||||
27112|NCT01652716|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||mg/dL||Standard Error|Least Squares Mean
27059|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 4 (OM 38) was the correct outcome measure to be registered.|||||
27060|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/kg||Standard Deviation|Mean
27061|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 1 (OM 36) was the correct outcome measure to be registered.|||||
27062|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.|||||
27063|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/kg||Standard Deviation|Mean
27064|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||hr||Standard Deviation|Mean
27065|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||hr||Standard Deviation|Mean
27066|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.|||||
27067|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||hr||Standard Deviation|Mean
27068|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
27069|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
27082|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||hr||Standard Deviation|Mean
27070|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. AUCinf is not scientifically appropriate for repeated dosing (Cycle 4).|||||
27071|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
27072|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported since the actual dosing interval (tau) was longer than 3 weeks in some patients and AUC(0-d22) may not accurately represent multiple-dose exposure for these patients. Therefore only AUCtau, which represents exposure for the actual Cycle 4 interval, was reported for Cycle 4 (OM 40).|||||
27073|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg*hr/L||Standard Deviation|Mean
27074|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg/L||Standard Deviation|Mean
27075|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mg/L||Standard Deviation|Mean
27076|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/day/kg||Standard Deviation|Mean
27077|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort||mL/day/kg||Standard Deviation|Mean
27078|NCT01653158|Secondary|Circulating Tumor Cells (CTCs), CTCs Expressing Insulin-like Growth Factor 1 Receptor (IGF-1R), and Circulating Endothelial Cells (CECs)||Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)|The data of CTCs and CTCs expressing IGF-IR were limited. Analyses of these biomarkers in the aggregate population were not feasible due to insufficient numbers. The data of CECs were not analyzed due to insufficient levels for quantification.|||||
27079|NCT01653158|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure (OM) was not analyzed due to incomplete progression reporting, which could not permit accurate estimate of time to tumor progression (TTP).|||||
27080|NCT01653158|Secondary|Number of Participants With Objective Response (OR)|Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure was not reported because data was available in individual participant listing only and not statistically summarized for the analysis.|||||
27081|NCT01653158|Secondary|Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871|The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.|30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion|All enrolled participants who started treatment and had evaluable HAHA data||Participants|||Number
27084|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL/(mg/m^2)||Standard Deviation|Mean
27085|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL/(mg/m^2)||Standard Deviation|Mean
27086|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL||Standard Deviation|Mean
27087|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng/mL||Standard Deviation|Mean
27088|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
27089|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
27090|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng*hr/mL||Standard Deviation|Mean
27091|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng*hr/mL||Standard Deviation|Mean
27092|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||ng*hr/mL||Standard Deviation|Mean
27093|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.||nanogram*hour/millilitre (ng*hr/mL)||Standard Deviation|Mean
27094|NCT01653158|Primary|Recommended Phase 2 Dose (RP2D)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment.||mg/kg|||Number
27095|NCT01653158|Primary|Maximum Tolerated Dose (MTD)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment, but excluding those who were enrolled in the expansion cohort.||mg/kg|||Number
27096|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||participants|||Number
27097|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||participants|||Number
27113|NCT01652716|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||Percentage of subjects|||Number
33774|NCT01541254|Secondary|Significant Stenosis(>50%) of the Treated Artery at 6 Months|Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.|6 months||||||
27098|NCT01653132|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) Scores|"measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.Drooling Frequency and Severity Score. The Drooling Score equals the sum of the Severity and Frequency sub-scores. The range is 2-9, higher numbers represent worse drooling Drooling Severity Scale~= Never drools, dry~= Mild-drooling, only lips wet~= Moderate- drool reaches the lips and chin~= Severe- drool drips off chin & onto clothing~= Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale~1. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling"|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||units on a scale||Standard Deviation|Mean
27099|NCT01653132|Primary|Objectively Measured Percentage Salivary Weight|Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||percentage change from baseline||Standard Deviation|Mean
27100|NCT01653132|Primary|Objectively Measured Salivary Weight|Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|||gm||Standard Deviation|Mean
27101|NCT01653028|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|During treatment and up to 5 years|All patients that began study treatment were assessed for this endpoint.||participants|||Number
27102|NCT01653028|Secondary|Progression Free Survival (PFS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).|The time between registration to disease progression or death, assessed up to 18 months|||Weeks||95% Confidence Interval|Median
27103|NCT01653028|Secondary|Overall Survival (OS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).|The time between registration and death, assessed up to 18 months|||Weeks||95% Confidence Interval|Median
27104|NCT01653028|Primary|The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.|The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.|Up to 18 months|||percentage of patients with response|||Number
27105|NCT01652729|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)|The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.|Baseline to Week 16|Meal Test Evaluable Population: The Meal Test Evaluable Population consists of all modified ITT subjects who participated in the meal test, consumed at least 75% of the standardized meal and had no missing 2-hour postprandial glucose measurements at both Visit 3 (Day 1) and Visit 8 (Week 16), and have adequate study drug exposure.||mg/dL||Standard Error|Least Squares Mean
27106|NCT01652729|Secondary|Change in Body Weight (kg) From Baseline to Week 28|The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||kg||Standard Error|Least Squares Mean
27107|NCT01652729|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||mg/dL||Standard Error|Least Squares Mean
27108|NCT01652729|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||percentage of subjects|||Number
27109|NCT01652729|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||percentage of total hemoglobin||Standard Error|Least Squares Mean
27110|NCT01652716|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16|Change in 2-hour postprandial glucose concentrations from baseline to Week 16.|Baseline to Week 16|Meal Test Evaluable Subjects: Subjects who were randomized and received at least one dose of study drug and who participated in the meal test at Visit 3 and Visit 13, had adequate and reliable data for the postprandial data evaluation, and had adequate study medication exposure.||mg/dL||Standard Error|Least Squares Mean
27111|NCT01652716|Secondary|Change in Body Weight (kg) From Baseline to Week 28|Change in body weight (kg) from baseline to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.||kg||Standard Error|Least Squares Mean
27114|NCT01652716|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug||Percentage of total hemoglobin||Standard Error|Least Squares Mean
27115|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
27116|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
27117|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in VLDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
27118|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
27119|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Non-HDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
27120|NCT01652703|Secondary|Percentage of Participants With an LDL-C Response at Week 12|An LDL-C response was defined as LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.|Week 12|Full analysis set||percentage of participants|||Number
27121|NCT01652703|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
27122|NCT01652703|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
27123|NCT01652690|Secondary|Number of Participants With Serious ADRs to Denosumab|Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an “other significant medical hazard” that does not meet any of the above criteria.|24 months|Full analysis set||participants|||Number
27124|NCT01652690|Secondary|Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab|Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).|24 months|Full analysis set||participants|||Number
27125|NCT01652690|Primary|Number of Participants Having Osteoporosis Related Laboratory Examinations|Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.|Pre-baseline (before first denosumab injection) and post-baseline|Full analysis set; n = participants with visits at each time point.||participants|||Number
27126|NCT01652690|Primary|Number of Participants Having Radiologic Bone Assessments|Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.|Pre-baseline (before first denosumab injection) and during the study (post-baseline)|Full analysis set||participants|||Number
27127|NCT01652690|Primary|Number of Denosumab Post-baseline Injections Received by Each Participant||24 months|Full analysis set||participants|||Number
27128|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.|Month 24|Full analysis set participants who received a fourth post-baseline injection (i.e. at month 24)||participants|||Number
27129|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.|Month 18|Full analysis set participants who received a third post-baseline injection (i.e. at month 18)||participants|||Number
27130|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.|Month 12|Full analysis set participants who received a second post-baseline injection (i.e. at month 12)||participants|||Number
27131|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.|Month 6|Full analysis set participants who received a first post-baseline injection (i.e. at month 6)||participants|||Number
27132|NCT01652690|Primary|Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.|Baseline (day 1)|Full analysis set||participants|||Number
27133|NCT01652690|Primary|Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care||24 months|Full analysis set participants who discontinued the study prematurely||participants|||Number
27134|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab|Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician’s office.|Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set||participants|||Number
33775|NCT01541254|Secondary|Successful Delivery of the LVIS™ Device Measures by Technical Success|Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.|24 hours||||||
27135|NCT01652690|Primary|Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection||Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set; n = the number of participants who received the corresponding injection||participants|||Number
27136|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician’s Office|Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.|24 months|Full analysis set (all enrolled patients who provided informed consent and received at least one injection)||participants|||Number
27137|NCT01652664|Primary|Mean Change From Baseline in IOP at Month 3|IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.|Baseline (Day 0), Month 3|All participants who received study drug and completed at least 1 scheduled on-therapy visit. No imputation was used, therefore the analysis included only observed cases.||mmHg||Standard Error|Mean
27138|NCT01652495|Secondary|Reduction of Pain Severity Expressed as Percentage Change in VAS Score|"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145–148."|180 days after treatment|||percentage of pain reduction||95% Confidence Interval|Mean
27139|NCT01652495|Secondary|Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis|"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values"|45 days after treatment|||% of patients with HPA suppression|||Number
27140|NCT01652495|Primary|Functional Improvement Measured According to Percentage Change in Constant Score|"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4."|180 days after treatment|||percentage of improvement Constant score||95% Confidence Interval|Mean
27141|NCT01652001|Secondary|Sialometries|"Unstimulated and stimulated salivary flow rates were assessed in all patients. The unstimulated salivary flow rate was obtained by the spit method every 30 seconds for 15 minutes. Saliva was collected in 20 mL plastic containers, which were pre-weighted.~Stimulated whole saliva was obtained by chewing a 1 g piece of paraffin wax for six minutes. Saliva collected during the first minute was discarded, and then collected into the container every 30 seconds."|2 weeks|||mL/min||Standard Deviation|Mean
27142|NCT01652001|Primary|Dry Mouth Questionnaire (DMQ)|"Dry Mouth Questionnaire (DMQ) was used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo.~Every participant answered an initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray (1% malic acid or placebo). After two weeks of applications, patients had to answer DMQ 1 again as well as an additional questionnaire (DMQ 2) about the efficacy of the sprays. Increased DMQ scores indicate improvement of xerostomia. DMQ 1 was used to assess the initial severity of oral dryness and in particular its impact on oral function: problems when chewing, swallowing, speaking and general impact on daily life.~DMQ 1 used a 0-to-4 rating scale where 0 = very dry and 4 = not dry at all. After two weeks of treatment, DMQ 1 was repeated and it was included DMQ 2.~At the end values of DMQ 1 and DMQ 2 were summed"|2 weeks|||units on a scale||Standard Deviation|Mean
27143|NCT01651949|Primary|Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
27144|NCT01651949|Primary|Percentage of Participants With an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
27145|NCT01651949|Secondary|Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|Four weeks post vaccination 3 (Month 7)|The analysis set includes participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.||Percentage of Participants||95% Confidence Interval|Number
27146|NCT01651949|Primary|Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)|Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
30297|NCT01600287|Secondary|Intra-operative Awareness|The number of patients who will be able to recall the intra-operative events when assessed postoperatively. This will be assessed by a structured protocol|Approximately 3 days and then 1 month later|||participants|||Number
27147|NCT01651949|Primary|Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.||Percentage of Participants|||Number
27148|NCT01651949|Primary|Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL|Four weeks post vaccination 3 (Month 7)|The analysis set includes heterosexual male and female participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
27149|NCT01651351|Secondary|Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA|Number of participants with seroconversion|105 days|Safety Analysis Set||participants|||Number
27150|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion|Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration|72 hours post infusion to 14 days post infusion|Safety Analysis Set||adverse events|||Number
27151|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion|Number of AEs that occurred during an infusion and were deemed related to study product administration|Day 1 and Day 15|Safety Analysis Set||adverse events|||Number
27152|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment|Within 72 hours of the end of infusion|Safety Analysis Set||Infusions|||Number
27153|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment|Within 24 hours of the end of infusion|Safety Analysis Set||Infusions|||Number
27154|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion|Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment|Within 1 hour of infusion completion|Safety Analysis Set||Infusions|||Number
27155|NCT01651351|Primary|Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)||Day 1 and Day 15|Safety Analysis Set||Infusions|||Number
27156|NCT01651260|Secondary|Ease of Use|Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);|Between 1 - 14 days|||% rating with score of 4 and 5|||Number
27157|NCT01651260|Primary|Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use|Number of participants with damage of ET tube and Number of participants with occlusion of ET tube|14 days|||participants|||Number
27158|NCT01651208|Secondary|4-Item Morisky Medication Adherence Scale (MMAS-4)|The Morisky 4-Item Medication Adherence Scale (MMAS-4) is a self-reported measure of medication-taking behavior. Available in 33 languages, it addresses barriers to medication-taking. Each question can be answer as Yes=0 (experiencing a barrier or difficulty taking the medication of interest as prescribed) or No=1 for a range of 0-4. A perfect score (reflecting best possible adherence) would be a score of 4.|At 12 month post stent placement|||Score on a Scale||Standard Deviation|Mean
27159|NCT01651208|Primary|Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)|Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR>=.80 to define the binary outcome of Appropriate Adherence|12 months after receiving coronary stent|||participants|||Number
27160|NCT01651104|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
27161|NCT01651104|Primary|Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
27162|NCT01651104|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
33776|NCT01541254|Secondary|Parent Artery Patency Measured Angiographically at 6 Months|To be assessed by Independent Core Lab.|6 months||||||
27163|NCT01651104|Primary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area.~The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
27164|NCT01651000|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol||participants|||Number
27165|NCT01651000|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat||participants|||Number
27166|NCT01651000|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Per protocol||participants|||Number
27167|NCT01651000|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Intent to treat||participants|||Number
27168|NCT01650831|Primary|Positive/Negative for H.Pylori With Modified BreathID|The amount of subjects that produced positive/negative results for H.pylori with modified BreathID|1 hour|Per protocol subjects tested with modified BreathID||participants|||Number
27169|NCT01650831|Primary|Positive/Negative for H.Pylori With Cleared BreathID|The amount of subjects that produced positive/negative results with cleared BreathID device|1 hour|Per protocol positive/negative when testing with marketed BreathID||participants|||Number
27170|NCT01650831|Primary|Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori|The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.|25 minutes|Only subjects that had no recent knowledge of existing H.pylori infection and who met all protocol criteria and had no major protocol deviations, were included in the final analysis set (PP-per protocol).||Percentage of participants||95% Confidence Interval|Number
27171|NCT01650805|Secondary|Overall Survival|To compare, according to treatment with ponatinib versus imatinib, overall survival|Up to 8 years after the last patient’s first dose||||||
27172|NCT01650805|Secondary|Progression-free Survival|To compare, according to treatment with ponatinib versus imatinib, progression-free survival|Up to 8 years after the last patient’s first dose||||||
27173|NCT01650805|Secondary|Complete Cytogenetic Response (CCyR) Rate|The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.|12 months after first dose|Patients with 12 month assessment||participants|||Number
27174|NCT01650805|Secondary|<10% BCR-ABL^IS Rate|To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib|3 months after first dose|Patients with 3 month assessment||participants|||Number
27175|NCT01650805|Secondary|MMR Rate|To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years|5 years after first dose||||||
27176|NCT01650805|Primary|Major Molecular Response (MMR) Rate at 12 Months|A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.|12 months after first dose|Patients with 12 month assessment (due to early termination of the study, none of the endpoints could be evaluated as planned).||participants|||Number
27177|NCT01650779|Secondary|Percent Change From Baseline in Gastrointestinal (GI) Symptoms (Abdominal Pain, Abdominal Distention, and Bowel Irregularities) at Month 2, 4, and 6|Gastrointestinal symptoms (abdominal pain, abdominal distention, and irregular bowel movements) were to be assessed by a modified version of the Irritable Bowel Syndrome (IBS) Severity Scoring System. The modified IBS Severity Scoring System is a 7-item questionnaire. The severity score calculated by summing the scores of 5 of the 7 questions. Each of the 5 questions were scored on a scale of 0 to 100, leading to a total possible score range of 0 to 500, where higher scores indicate more severe gastrointestinal symptoms. The data for this outcome measure was exploratory and to be collected in individual participant listing only.|Baseline, Month 2, 4, 6|The data for this outcome measure was exploratory and to be collected in individual participant listing only. Analysis of this data was planned only if baseline data was collected on a large number of enrolled participants. This was not the case and therefore interpretation of these results were not possible.|||||
27190|NCT01650324|Secondary|Change of Dipeptidyl Peptidase 4 (DPP4) Activities Between 48 Hrs Post Dose and 0 hr Predose|Change of plasma DPP4 activity at 48 hrs post dose from predose (0 hr). The values were computed as areas under the DPP4 activity-time curve using ANCOVA model, in which the unit of the activity is pmol/min.|predose (0 hr) and 48 hrs post dose|All enrolled participants.||h*pmol/min||Standard Deviation|Geometric Mean
27779|NCT01642082|Secondary|Duration of Survival|Duration of survival is defined as the duration alive from study entry until death or last contact.|Patients are followed every three months for the first two years and then every six months for the next three years.|All eligible and treated patients||months||90% Confidence Interval|Median
27178|NCT01650779|Secondary|Percent Change From Baseline in Urine GL-3 at Month 2, 4, and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for urine GL-3 was 0.2 mcg/mL. The absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing GL-3 (mcg/mL) by creatinine (mg/mL) and multiplying by 113.13 (mg/mmol), the molecular weight of creatinine. For levels reported BQL, the absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing 0.1 (mcg/mL) by creatinine (mg/mL) and multiplying by 133.13 (mg/mmol). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with urine GL-3 assessment at the specified time point.||percent change||Full Range|Median
27179|NCT01650779|Secondary|Percent Change From Baseline in Plasma Globotriaosylceramide (GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma GL-3 was 2.0 microgram per milliliter (mcg/mL). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma GL-3 assessment at the specified time point.||percent change||Standard Deviation|Mean
27180|NCT01650779|Primary|Percent Change From Baseline in Plasma Deacylated Globotriaosylceramide (Lyso-GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as below quantitative limit (BQL), the lower limit of quantitation (LLOQ) value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma lyso-GL-3 was 5.0 nanogram per milliliter (ng/mL). This study is exploratory because little is known about the dose-response of these biomarkers to enzyme replacement therapy (ERT) or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma Lyso-GL-3 assessment at the specified time point.||percent change||Standard Deviation|Mean
27181|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of time to rescue medication in the postoperative period.|24 hours|||Hours||Standard Deviation|Mean
27182|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site."|24 Hours|||units on a scale||Standard Error|Mean
27183|NCT01650519|Secondary|Incidence of Serious Adverse Events (SAEs).|Measurement of the incidence of serious adverse events.|24 hours|||Number of Events|||Number
27184|NCT01650519|Secondary|Patient Satisfaction.|"Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome.~Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)."|24 hours|||units on a scale||Standard Deviation|Mean
27185|NCT01650519|Secondary|Time to Discharge.|Measurement of the time to discharge in the postoperative period.|24 hours|||Hours||Standard Deviation|Mean
27186|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of rescue medication in the postoperative period.|24 hours|||milligrams||Standard Deviation|Mean
27187|NCT01650519|Primary|Efficacy of IV Ibuprofen for Post-op Pain.|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|first possible assessment following surgery|||units on a scale||Standard Deviation|Mean
27188|NCT01650350|Secondary|To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.||3 months||||||
27189|NCT01650350|Primary|Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST|Response will be assessed via RECIST 1.1 criteria utilizing interval CT scans and physical exam after every 3 cycles of treatment (i.e. every 12 weeks).|approximately every 3 months CT, every month physical, up to 6 months|||participants|||Number
27191|NCT01650324|Secondary|Profile of Pharmacokinetics - Time of Maximum Plasma Concentration (Tmax)|Plasma samples were used to determine the Time of Maximum Plasma Concentration for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.||hrs||Full Range|Median
27192|NCT01650324|Secondary|Profile of Pharmacokinetics - Observed Maximum Plasma Concentration (Cmax)|Plasma samples were used to determine the Cmax for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.||ng/mL||Standard Deviation|Geometric Mean
27193|NCT01650324|Secondary|Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity)|Plasma samples were used to determine the AUC from time 0 to infinity for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.||ng*h/mL||Standard Deviation|Geometric Mean
27194|NCT01650324|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|There were 4 mild adverse events observed during the course of study.|Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.|All enrolled participants.||participants|||Number
27195|NCT01650285|Other Pre-specified|Time to Progression and Overall Survival for Patients-Following Radical Prostatectomy and Were Treated With Cabazitaxel.||24 months||||||
27196|NCT01650285|Secondary|Toxicity Associated With Cabazitaxel and Adjuvant Radiation||2 mos||||||
27197|NCT01650285|Primary|Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation|The MTD was not determined secondary to the study closing early. That being said the numbers provided below show that 4 patients were treated on study to aide in the investigation of the MTD. Only 1 dose was fully evaluated which was 5mg/m2|2 mos|while 5 participants were enrolled only 4 completed treatment as patients # 5 only received part of day 1 therapy secondary to an AE and therefore is not included in the assessment.||mg/m2|||Number
27198|NCT01650246|Primary|Incidence of Treatment-emergent Adverse Events (TEAEs)||Up to approximately 2 years|Safety Population||TEAEs|||Number
27199|NCT01650246|Primary|Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL||Month 1|Safety Population||Subjects|||Number
27200|NCT01649856|Secondary|Duration of Overall Survival (OS) at the Time of Primary Analysis|OS was defined as the time from randomization to death from any cause. The duration of OS was to be determined using Kaplan-Meier analysis.|Up to approximately 2 years (survival followed from randomization until death)|ITT Population.||weeks||Full Range|Median
27201|NCT01649856|Secondary|Number of Deaths at the Time of Primary Analysis|The number of participants who had experienced death prior to the clinical cut-off date (October 2014) was determined.|Up to approximately 2 years (survival followed from randomization until death)|ITT Population.||participants|||Number
27202|NCT01649856|Secondary|Duration of Progression-Free Survival (PFS) at the Time of Primary Analysis|PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The duration of PFS was to be determined using Kaplan-Meier analysis.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)|ITT Population.||weeks||Full Range|Median
27203|NCT01649856|Secondary|Number of Participants With Progression, Relapse, or Death at the Time of Primary Analysis|Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced progression, relapse, or death prior to the clinical cut-off date (October 2014) was determined.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)|ITT Population.||participants|||Number
27204|NCT01649856|Secondary|Duration of Disease-Free Survival (DFS) at the Time of Primary Analysis|DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The duration of DFS was to be determined at the time of clinical cut-off (October 2014) using Kaplan-Meier analysis.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)|ITT Population (Responder Subpopulation).||weeks||Full Range|Median
27205|NCT01649856|Secondary|Number of Participants With Relapse or Death at the Time of Primary Analysis|Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)|ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles.||participants|||Number
30886|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with soluble huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population||mg/mL||Standard Deviation|Mean
27206|NCT01649856|Secondary|Duration of EFS at the Time of Primary Analysis|EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The duration of EFS was to be determined at the time of clinical cut-off (October 2014) using Kaplan-Meier analysis.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days]; every 3 months thereafter; and/or 4 weeks after early termination)|ITT Population.||weeks||Full Range|Median
27207|NCT01649856|Secondary|Number of Participants With an Event-Free Survival (EFS) Event at the Time of Primary Analysis|EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants with one or more EFS events prior to the clinical cut-off date (October 2014) was determined.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days]; every 3 months thereafter; and/or 4 weeks after early termination)|ITT Population.||participants|||Number
27208|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle|"Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.||percentage of participants|||Number
27209|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle|"Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.||percentage of participants|||Number
27210|NCT01649856|Secondary|Median Duration of Rituximab Administration for Each Treatment Cycle|Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population; n = number of participants in the analysis for the specified timepoint.||hours||Full Range|Median
27211|NCT01649856|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.||units on a scale||Standard Deviation|Mean
27212|NCT01649856|Secondary|Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores|The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.||units on a scale||Standard Deviation|Mean
27213|NCT01649856|Primary|Percentage of Participants With CR or CRu at the Time of Primary Analysis|Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (>) 75 percent (%) but still >1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).|Up to approximately 7 months (assessed at Baseline, Cycle 4, and 30 days after the start of the last rituximab cycle [maximum 8 cycles; each cycle was 14 or 21 days])|Intent-to-Treat (ITT) Population: All participants who completed Baseline and at least one on-treatment efficacy assessment.||percentage of participants||95% Confidence Interval|Number
27214|NCT01649804|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible scores range from 0 to 3, where 0=least difficulty, and 3=extreme difficulty.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||units on a scale||Standard Deviation|Mean
27215|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain|"A participant's overall assessment of pain on a VAS was assessed with a question concerning the amount of pain due to arthritis. Pain was assessed on a 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm)."|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
27216|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity|The participant global assessment of disease activity was measured using a 100 mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
27217|NCT01649804|Secondary|Time to Rheumatoid Arthritis (RA) Flare|RA flare was defined as any worsening of the participant’s disease activity that in the opinion of the Investigator required treatment intensification beyond supportive therapy which included restarting of the study drug treatment. Time to RA flare was defined as the period of drug-free remission until documentation of RA flare. Drug-free remission was defined as clinical remission (based on DAS28-ESR < 2.6 and /or SDAI ≤ 3.3) for two consecutive assessment visits, followed by discontinuation of tocilizumab, at the Investigator's discretion, at the second assessment visit.|End of Study (Week 104 or early withdrawal)|This outcome could not be evaluated as there were no participants who had achieved drug-free remission, per protocol definition.|||||
27218|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)|Swollen joint count was performed by a skilled assessor, evaluating 66 joints for swelling.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
27219|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)|Tender joint count was performed by a skilled assessor, evaluating 68 joints for tenderness.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."||participants|||Number
27220|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)|The SDAI was defined as the numerical sum of 5 outcome parameters: tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity on a 100 millimeter (mm) Visual analogue scale (VAS) (VAS; 0 = no disease activity and 100 = worst disease activity) and level of C-reactive protein (CRP) (milligram per deciliter [mg/dl], normal < 1 mg/dl). SDAI total score = 0-86 where a higher score reflects worsening disease. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||participants|||Number
27221|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)|The DAS28 (ESR) score is a measure of the participant's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR) and general health status. The DAS28-ESR scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity, DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||participants|||Number
27222|NCT01649804|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.||percentage of participants|||Number
27223|NCT01649791|Secondary|Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry|PI left the institute and the data was not collected.|8 days|No participants were analyzed.|||||
27224|NCT01649791|Secondary|Incidence of Immune Mediated Flare Reaction|Number of participants with Tumour flare.|24 months|All treated and eligible patients.||participants|||Number
27225|NCT01649791|Secondary|Overall Response Rate (CR+PR)||24 months|All treated and eligible patients.||percentage of participants|||Number
27226|NCT01649791|Primary|Median Progression-free Survival||24 months|All treated and eligible patients.||months||95% Confidence Interval|Median
27227|NCT01649557|Secondary|Percentage of Participants Who Discontinued Due to Lack of Efficacy.|Discontinuation rate for the participants discontinued due to lack of efficacy were examined.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Percentage of participants.|||Number
27228|NCT01649557|Secondary|Percentage of Participants With a Positive Response Rate.|Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Percentage of participants|||Number
27229|NCT01649557|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
27230|NCT01649557|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
27231|NCT01649557|Secondary|Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.|The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
27232|NCT01649557|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.|The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 1, 2, 6, 26, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Full Range|Median
27233|NCT01649557|Secondary|Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.|The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?” Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
27234|NCT01649557|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.||Units on a scale||Standard Deviation|Mean
27235|NCT01649557|Primary|Number of Participants With AEs in 52-Week Enrollers.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 52 weeks|Those participants who received at least one dose of open-label brexpiprazole and who were enrolled in the 52-week study.||Participants|||Number
27236|NCT01649557|Primary|Number of Participants With Adverse Events (AEs) During First 6 Weeks.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 6 weeks|The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole and were enrolled in the 6-week study.||Participants|||Number
27237|NCT01649505|Secondary|Serious and Nonserious Adverse Events and Complications||Up to day 180 post-operation||||||
27238|NCT01649505|Secondary|Quantity of Post-operative Drainage|Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.|Up to day 10 post-operation||||||
27597|NCT01644396|Other Pre-specified|Change From Baseline in Total Protein|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||g/L||Standard Deviation|Mean
27239|NCT01649505|Secondary|Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications|Computed with 95% confidence interval using exact method. Two-sided Fisher’s exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed.|Up to day 180 post-operation||||||
27240|NCT01649505|Primary|Proportion of Patients in Each Arm Who Develop Post-operative Seromas|Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher’s exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.|Up to day 180 post-operation||||||
27241|NCT01649362|Secondary|Breastfeeding Rate at Discharge||hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction|||participants|||Number
27242|NCT01649362|Secondary|Length of Hospital Stay||participants were followed for the duration of hospital stay, an expected average of 5 weeks|||days||Standard Deviation|Mean
27243|NCT01649362|Primary|Length of Transition Period|transition period was defined as the period from the introduction of enteral feeding to full enteral feeding|participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks|||days||Standard Deviation|Mean
27244|NCT01649297|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 16|"Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.~Means provided are the adjusted means."|Baseline and 16 weeks|FAS with LOCF has been used for FPG analyses||mg/dL||Standard Error|Mean
27245|NCT01649297|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16|"Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.~Means provided are the adjusted means."|Baseline and 16 weeks|"Full Analysis Set (FAS) is the basis for the intention-to-treat analysis. FAS with last observation carried forward (LOCF) imputation is used as the primary method of accounting for missing data.~Values after the patient started rescue medication were excluded from analysis (and imputed with an LOCF procedure)."||percentage of HbA1c||Standard Error|Mean
27246|NCT01649232|Secondary|Number of Omission and Commission Errors of Behavior Task|After VCPT task, errors by Omission (lack of response in test GO) and by commission (lack of suppression in NOGO and NOVELTY test) were automatically counted for each subject.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.||Number of omission and commision errors||Standard Deviation|Mean
27247|NCT01649232|Secondary|Reaction Time (Behavior Task)|"All subjects performed a Visual continuous performance task (VCPT) with GO/NOGO paradigm. It consists of three types of stimuli: 1) twenty animals (A), 2) twenty images of different plant (P), 3) Twenty images of people of different professions (H) which is present with an artificial sound called Novel 20msec and.Thus, each pair of stimulus is presented for 100 milliseconds, at intervals of one second of duration between each block. The objective of is to press a button as quickly as possible while observing the pairs AA, situation called GO, while trying not to press when observes other types of pairs. This latency of response (reaction time) was mensured. Pairs are called GO(AA) NOGO(AP), IGNORE(PP) and NOVEL(PH + Sound). Errors by omission (lack of response in test GO) and by commission (lack of suppression in NOGO test) were be automatically counted for each subject."|From September to December 2012|||milliseconds||Standard Deviation|Mean
27248|NCT01649232|Secondary|Event-related Potentials Latency (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain’s executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012|||milliseconds||Standard Deviation|Mean
27249|NCT01649232|Secondary|Event-related Potentials Amplitude (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain’s executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.||microVolts||Standard Deviation|Mean
27260|NCT01648920|Primary|Sensitivity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Sensitivity is a way of saying how likely a test is positive if you have a disease and is expressed as (%) percent. For this study, sensitivity was the ability of FeNO to correctly identify a study participant who has asthma."|approximately 1-hour|||percent|||Number
30887|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of whole brain iron concentrations.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.||mm^3||Standard Deviation|Mean
27250|NCT01649232|Primary|Clinical Assessment (Amen Questionnaire)|"The Amen Attention Deficit Disorder (ADD) Type Questionnaire is a 71-question self-test that evaluates the ADD syndrome. 0 never, 1 rarely, 2 Occasionally, 3 Often and 4 Very Often. Consists of a series of questions that evaluate five brain systems: basal ganglia (23 items), Cingular System (17 items), Temporal System (16 items), Prefrontal Cortex (24 items) and deep limbic system (20 items). Each system has a maximum score of 4, and if this punctuation is greater than 1.7 it is possible that the system is deviated from normality and implicated in AD/HD behavior.~The minimal average score is 5 (Best) and the maximum is 20 (Worst). More than four is suspicious of diagnosis, six or more of a score of three or four is needed to make diagnosis. Meets the criteria for inattentiveness (six or more on questions 1-14) and also scores six or more on the cingular system questions (24-36 items), over-focused ADD subtype is suspected."|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.||units on a scale||Standard Deviation|Mean
27251|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour|||participants|||Number
27252|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=25ppb to <=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour|||participants|||Number
27253|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not smoke previously or are current smokers."|approximately 1-hour|||participants|||Number
27254|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <=25ppb to <=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour|||participants|||Number
27255|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour|||participants|||Number
27256|NCT01648920|Primary|FeNO Values by ICS Use: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour|||participants|||Number
27257|NCT01648920|Primary|Negative Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Negative predictive value is a way of saying the likelihood of a negative test means you do not have disease. In this study it is defined as the percentage of study participants with a low FeNO who do not have asthma."|approximately 1-hour|||percent|||Number
27258|NCT01648920|Primary|Positive Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Positive predictive value is a way of saying the likelihood a positive test means you have a disease. In this study, it is defined as the percentage of study participants with a high FeNO who have asthma."|approximately 1-hour|||percent|||Number
27259|NCT01648920|Primary|Specificity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Specificity is a way of saying how likely a test is negative if you do not have a disease and is expressed as (%) percent. For this study, specificity was the ability of FeNO to correctly identify a study participant who does not have asthma."|approximately 1-hour|||percent|||Number
28457|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Average of on State and Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
27261|NCT01648920|Primary|Asthma Diagnosis by FeNO: Mean FeNO Value|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||Parts per billion (ppb)||Standard Deviation|Mean
27262|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
27263|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
27264|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
27265|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Negative MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|||participants|||Number
27266|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Positive MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine."|approximately 1-hour|||participants|||Number
27267|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >50ppb||participants|||Number
27268|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >= 25 ppb to <= 50 ppb||participants|||Number
27269|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with a FeNO < 25 ppb||participants|||Number
27270|NCT01648920|Primary|Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||parts per billion (ppb)||Standard Deviation|Mean
27271|NCT01648920|Primary|Methacholine Challenge (MCC) Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour|||participants|||Number
27272|NCT01648790|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
27273|NCT01648790|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
27274|NCT01648790|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
27275|NCT01648790|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
27276|NCT01648699|Secondary|Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician|"The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from very much worse to very much improved (as compared to Baseline)."|Day 28|"ITT population included all participants who received at least one dose of study medication at Baseline. n signifies those participants who were evaluated for this measure at the specified time point. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."||Participants|||Number
27277|NCT01648699|Secondary|Number of Participants Given Rescue Pain Medications|Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.||Participants|||Number
27278|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Day 28|The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
27279|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Baseline|The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Baseline|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.||Units on a scale||Standard Deviation|Mean
27280|NCT01648582|Secondary|Change From Baseline in EQ-5D Visual Analog Scale Score|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||units on a scale||Standard Deviation|Mean
27281|NCT01648582|Secondary|EQ-5D Health State Score Responses|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||participants|||Number
27282|NCT01648582|Secondary|Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
27285|NCT01648582|Secondary|Number of Participants With Adjudicated Pancreatitis|Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks and 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||participants|||Number
27286|NCT01648582|Secondary|Number of Participants With Adjudicated Cardiovascular (CV) Events|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||participants with adjudicated CV events|||Number
27287|NCT01648582|Secondary|Change From Baseline in Serum Calcitonin||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picomole/liter||Standard Deviation|Mean
27288|NCT01648582|Secondary|Change From Baseline in Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||Units/Liter (U/L)||Standard Deviation|Mean
27289|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)|Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the analysis of variance (ANOVA) model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||beats per minute (bpm)||Standard Deviation|Least Squares Mean
27290|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||millisecond (msec)||Standard Deviation|Least Squares Mean
27291|NCT01648582|Secondary|Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate|Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||beats per minute (bpm)||Standard Deviation|Least Squares Mean
27292|NCT01648582|Secondary|Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||millimeters of mercury (mmHg)]||Standard Deviation|Least Squares Mean
27293|NCT01648582|Secondary|Number of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks and 52 Weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
27294|NCT01648582|Secondary|Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants in the safety population who were randomized and received at least 1 dose of study drug.||events per participant per year||Standard Deviation|Mean
27306|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire|"The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible."|Baseline and 6 months|||units on a scale|||Number
27307|NCT01648491|Primary|Study-Related Adverse Events||6 months|||Adverse Events|||Number
27295|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks|The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an ANCOVA model with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.||percentage of HOMA2-%S||Standard Error|Least Squares Mean
27296|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks|The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using an analysis of covariance (ANCOVA) model with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
27297|NCT01648582|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks|Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||mmol/L||Standard Error|Least Squares Mean
27298|NCT01648582|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
27299|NCT01648582|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|Up to 26 and 52 weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the last observation carried forward (LOCF) method.||percentage of participants|||Number
27300|NCT01648582|Secondary|Change From Baseline in HbA1c at 52 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.|Baseline, 52 Weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||percentage of HbA1c||Standard Error|Least Squares Mean
27301|NCT01648582|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks|Participants who were randomized, received at least 1 dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.||percentage of HbA1c||Standard Error|Least Squares Mean
27302|NCT01648530|Primary|Migraine Disability Assessment (MIDAS)|The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged.|12 Months|All qualified participants at Baseline who returned completed survey with positive screening for migraines.||days||Standard Deviation|Mean
27303|NCT01648530|Primary|Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)|EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.|Baseline|All qualified participants at Baseline who returned completed survey with positive screening for migraines.||percentage of participants|||Number
27304|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)|The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.|6 months|||units on a scale|||Number
27305|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)|The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.|6 months|||units on a scale|||Number
27308|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Untreated Control Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
27309|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Study Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
27310|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Untreated Control Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
27311|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Study Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
27312|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Untreated Control Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .~The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
27313|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Study Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .~The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||participants|||Number
27314|NCT01648452|Secondary|Number of Non-Ocular Adverse Events at All Time Points Post-Implantation|The total number of non eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
27315|NCT01648452|Secondary|Number of Ocular Adverse Events at All Time Points Post-Implantation|The total number of eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
27316|NCT01648452|Secondary|Number of Severe Adverse Events at All Time Points Post-Implantation|"The total number of severe adverse events reported from Day 1 post-implantation through study completion at Year 3.~Although there were two serious adverse events (SAEs) reported during the study, only one event's severity was classified as severe."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
27317|NCT01648452|Secondary|Number of Adverse Events at All Time Points Post-Implantation|The total number of adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation|||Adverse Events|||Number
27318|NCT01648452|Primary|Number of Non-Ocular Adverse Events at Six Months Post-Implantation|The number of non eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
27319|NCT01648452|Primary|Number of Ocular Adverse Events at Six Months Post-Implantation|The number of eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
27320|NCT01648452|Primary|Number of Severe Adverse Events at Six Months Post-Implantation|The number of severe adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
27321|NCT01648452|Primary|Number of Adverse Events at Six Months Post-Implantation|The primary outcome is the total number of adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation|||Adverse Events|||Number
27349|NCT01647464|Primary|Renal Video Intensity Units|Video intensity units in the kidney 10 min after completion of a clinically indicated contrast echocardiography study.|10 min|||units on a scale||Standard Deviation|Mean
35465|NCT01516879|Secondary|Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set||mg/dL||Standard Error|Least Squares Mean
27322|NCT01648101|Secondary|Incidence of New Seizure Types During the TrP in Participants Without a History of the Indicated Seizure Types at Baseline|A participant was considered to have new seizure types during the TrP if they experienced a new seizure types (such as SE, myoclonic, absence, secondary generalization) and had no prior history of these seizure types. At Screening, a history of previous seizure types was collected, with “Yes,” “No,” “IS,” “SE,” or “Unknown” being recorded for each of the seizures types. The history of seizure types was updated during the 8-week BP as pre-treatment status. New types of seizures during the TrP were recorded as A1=simple PS with motor signs; AX=simple PS without motor signs; B=complex PS; C=PS evolving to secondary generalized seizures; D1=absence of seizures; D2=myoclonic seizures; D3=clonic seizures; D4=tonic seizures; D5=tonic-clonic seizures; D6=atonic seizures; E=unclassified seizures; and SE=status epilepticus.|From Baseline up to Week 16|ITT Population.||Number of events|||Number
27323|NCT01648101|Secondary|Percentage of Seizure-free Days in the TrP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the TrP (TiP plus MP) / number of applicable days in the TrP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Baseline up to Week 16|ITT Population.||Percentage of seizure-free days||Standard Deviation|Mean
27324|NCT01648101|Secondary|Percentage of Seizure-free Days in the MP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the MP / number of applicable days in the MP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Week 4 up to Week 16|ITT Population.||Percentage of seizure-free days||Standard Deviation|Mean
27325|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the TrP|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. A participant was considered to be seizure free if they experienced no seizures in the TiP or MP regardless of how long they were in the study."|From Baseline up to Week 16|ITT Population.||Participants|||Number
27326|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the MP, ITT Population|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. Participants who did not complete the study or experienced any seizures in the MP were not considered to be seizure free. A participant who completed the study AND had no seizures during the maintenance phase were counted to be seizure free. Also, a completer who only had seizures during the TiP is considered seizure free."|Baseline; Week 4 up to Week 16|ITT Population.||Participants|||Number
27327|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP Categorized as: >25% Increase and 0% to 25% Increase|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
27328|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: >25% Increase and 0% to 25% Increase|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
27350|NCT01647438|Primary|Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake|Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months|baseline and 6-months|||percentage of kilocalories||Standard Error|Mean
27351|NCT01647438|Primary|Change in Physical Activity (Minutes/Week)|Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.|baseline and 6-months|||min/week||Standard Error|Mean
27598|NCT01644396|Other Pre-specified|Change From Baseline in Albumin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||g/L||Standard Deviation|Mean
27329|NCT01648101|Secondary|Percent Change From Baseline in 28 Day Total POS Frequency During the TrP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
27330|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of >=1 occurrence of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline. There was no theoretical upper limit for worsening. Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial status or not).|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.|||||
27331|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others both Titration and Maintenance Phase data were used||Percent change||Full Range|Median
27332|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|Baseline; Week 4 up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others, only MP data were used.||Percent change||Full Range|Median
27333|NCT01648101|Secondary|Number of Responders From the BP to the Treatment Phase (TrP)|A “responder” is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the TrP (TiP plus MP). The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not).|From Baseline up to Week 16|Intent-to-Treat (ITT) Population||Participants|||Number
27334|NCT01648101|Secondary|Number of Placebo and Retigabine 600 mg Responders During the MP|A “responder” is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the MP, randomly assigned to retigabine 600 mg/day compared to placebo. The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not).|Baseline; Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.||Participants|||Number
27335|NCT01648101|Primary|Number of Placebo and Retigabine 900 mg Responders During the Maintenance Phase (MP)|A responder is defined as a par. with >=50% reduction in the 28 day total partial on-set seizure (POS) frequency from the Baseline Phase (BP) to the MP, randomly assigned to retigabine 900 mg/day compared with placebo. The total 28-day POS rate was defined as: (total number of POS over the evaluable period (MP) / number of days of seizure (sz) data in the evaluable period) *28 days. In the event of one or more innumerable seizures (IS) occurring on a day, these were to be counted as an additional 10 seizures for that day, regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of MP minus start date of the MP minus days on which seizures were recorded as “Not done” + 1). Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial or not).|Baseline (BL); Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.||Participants|||Number
27336|NCT01647945|Secondary|Efficacy of Low-dose FK-506 in Pulmonary Arterial Hypertension (PAH) Measured by Change in 6-min Walk Distance (6MWD)|"Change in 6MWD in meter between baseline and 16 weeks~A large number would indicate an increase in exercise capacity"|baseline to 16 weeks|Only subjects were included who finished the 16-week study 3 patients did not finish||meter||Inter-Quartile Range|Median
27337|NCT01647945|Secondary|Number of Combined Clinical Events|"Combined Clinical Events @ 16 weeks:~Number of patients who died Number of patients who got transplanted Number of patients who needed escalation of therapies Number of patients who had worsening of NYHA/WHO classification by at least 1 point Number of patients who require hospitalization for right heart failure~Low numbers would suggest either efficacy of the study drug or slowly progression of disease that is studied during the 16 week study period or short observation period or small study population"|Baseline to 16 weeks|Subjects were included who finished the 16 week study period. A total of 3 participants did not complete the study||Combined Number of Clinical Events|||Number
27338|NCT01647945|Primary|Safety of Low-dose FK-506 in PAH|Total number of adverse events measured between baseline and end of study at 18 weeks as reported by study subjects such as nausea/diarrhea, URI, sinus congestion, infection, fluid retention/edema, cough, headache, bronchitis, fatigue, drug reaction/hives, flushing, anxiety, tremor, fever, shingles, SOB, insomnia, pain|18 weeks|all study subjects who started the study||number of AEs|||Number
27339|NCT01647737|Primary|Change in Salivary Flow From Baseline|Change in salivary flow in Xerostomic patients using Green tea lozenges|8 weeks|Enrolled subjects completing 8 weeks of treatment||ml/min||Standard Deviation|Mean
27340|NCT01647711|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).|28 days|Treated set including patients eligible for MTD determination||mg|||Number
27341|NCT01647711|Secondary|Determination of Dosage for Expansion Cohort in Part B|Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.|28 days|Treated set including patients eligible for MTD determination||mg|||Number
27342|NCT01647711|Secondary|Cmax of Afatinib on Day 3 of Course 1|Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A|47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)|Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
27343|NCT01647711|Secondary|Objective Response Rate for Patients With EGFR T790M Mutations|"Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): >=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.~This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants."|From first drug administration until last drug administration, up to 420 days|Treated set including participants with EGFR T790M positive mutations||Percentage of participants|||Number
27344|NCT01647711|Primary|Percentage of Participants With Dose Limiting Toxicities|Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.|28 days|Treated set including patients eligible for MTD determination||Percentage of participants|||Number
27345|NCT01647542|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24|The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.||mg/dL||Standard Error|Least Squares Mean
27346|NCT01647542|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|The change between the fasting plasma glucose value collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post baseline value were included||Milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
27347|NCT01647542|Secondary|Percentage of Participants With HbA1c <7% at Week 24||Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only Participants with a baseline and at least 1 post baseline value were included.||Percentage of participants|||Number
27348|NCT01647542|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full Analysis Set (FAS) included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.||Percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
27352|NCT01646827|Secondary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.|This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit.|Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
27353|NCT01646827|Secondary|Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.|Injection site pain was assessed using a VAS, which was completed by the trial participant, and the investigator’s assessment of most recent injection site, which was completed by the investigator. VAS is 100 mm line, 0=no pain, 100=unbearably painful.|Day 1, Day 14, Day 28 and last visit|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Units on a scale||Standard Deviation|Mean
27354|NCT01646827|Secondary|Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance|Three 12 lead ECGs were performed approximately 5 minutes apart at each time point. The participant were supine and at rest (for at least 10 minutes) prior to the first ECG and will remain supine through the final ECG. Based on criteria for identifying ECG measurements of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For bradycardia: ≤ 50 beats per minute (bpm); and for increase in QTc: QTc ≥ 450msec.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
27355|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate|Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of >/= 15 beats per minute were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
27356|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature|Vital sign assessment included body temperature measured in centigrade(C). Temperatures >=37.8°C and increase of >= 1.1°C were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
27357|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure|Vital sign assessment included orthostatic (supine and standing) blood pressure. Orthostatic assessments were made after participants had been in the supine position for at least 5 minutes and again after participants had been standing for 2 minutes, but not more than 3 minutes. Orthostatic hypotension defined as >/= 20 mm Hg decrease in systolic blood pressure and >/= 25 beats per minute increase in heart rate from supine to standing.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
27358|NCT01646827|Secondary|Number of Participants With Laboratory Values of Potential Clinical Relevance.|The laboratory tests were collected and processed in accordance with directions from the clinical chemistry laboratory. Based on criteria for identifying laboratory values of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For fasting triglycerides: men: ≥ 160 mg/dL and women: ≥ 120 mg/dL; Fasting glucose: ≥ 115 mg/dL; Prolactin: > upper limit of normal (ULN); Neutrophils: ≤ 1,500/mm3; and Creatine phosphokinase: ≥ 3 x ULN.|Day 1, Day 28, Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
27359|NCT01646827|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Starting at the time the ICF was signed to Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.||Participants|||Number
27360|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng day/mL||Standard Deviation|Mean
27361|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng/mL||Standard Deviation|Mean
27362|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng day/mL||Standard Deviation|Mean
27574|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on­ or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
27363|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Aripriprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.||ng/mL||Standard Deviation|Mean
27364|NCT01646814|Primary|Incidence of Gastroduodenal Ulcers|Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth|42 Days|Per protocol population (ie, Treated with ≥1 dose and Day 7 dose administered and endoscopy performed and ≥85% compliant)||participants|||Number
27365|NCT01646671|Secondary|Percentage of Participants With DBP Response at End of Study|DBP response was defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
27366|NCT01646671|Secondary|Percentage of Participants With SBP Response at End of Study|SBP response was defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
27367|NCT01646671|Secondary|Percentage of Participants Achieving Successful msDBP Control at End of Study|Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
27368|NCT01646671|Secondary|Percentage of Participants Achieving Successful msSBP Control at End of Study|Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
27369|NCT01646671|Secondary|Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study|Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||Percentage of Participants|||Number
27370|NCT01646671|Secondary|Change From Baseline in msSBP and msDBP at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.||mmHg||Standard Deviation|Mean
27371|NCT01646671|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths|Adverse events, serious adverse events deaths were monitored from screening to week 8.|Week 8|AE analysis was determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category. Other safety analysis was determined by the maximum treatment.||Percentage of participants|||Number
27372|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
27373|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
27575|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
27374|NCT01646398|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titer||95% Confidence Interval|Geometric Mean
27375|NCT01646398|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination|Evaluable immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A.||percentage of participants||95% Confidence Interval|Number
27376|NCT01646398|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titer||95% Confidence Interval|Geometric Mean
27377|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|6 months prior to and 6 months post switching etanercept|FAS population. Here “N” (number of participants analyzed): participants evaluable for this measure, “n”: participants evaluable for specified time-points. Only participants treated with ETN were to be analyzed for this outcome measure.||units on a scale||Standard Deviation|Mean
27378|NCT01646385|Secondary|Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score <=0.5 were considered in remission state.|Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||percentage of participants|||Number
27379|NCT01646385|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||units on a scale||95% Confidence Interval|Least Squares Mean
27380|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score at Baseline|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||units on a scale||Standard Deviation|Mean
27381|NCT01646385|Secondary|Time to Remission|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||years||95% Confidence Interval|Median
27382|NCT01646385|Secondary|Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||percentage of participants|||Number
27383|NCT01646385|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline, Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.||units on a scale||95% Confidence Interval|Least Squares Mean
27384|NCT01646385|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate [ESR, millimeter per hour] or C-reactive protein [CRP, milligram per liter]) and patient's general health assessment (recorded on a Visual Analog Scale [VAS] of 0 millimeter [mm]-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||units on a scale||Standard Deviation|Mean
27385|NCT01646385|Secondary|Time on Etanercept Therapy|Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.||years||95% Confidence Interval|Median
27386|NCT01646385|Secondary|Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation|Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.||percentage of participants|||Number
27387|NCT01646385|Primary|Crude Incidence Rate of All-Cause Mortality|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
27388|NCT01646385|Primary|Crude Incidence Rate of Other Serious Adverse Events|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
27389|NCT01646385|Primary|Crude Incidence Rate of Serious Infections|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as ‘serious infection’ in the field [serinf] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
27412|NCT01646255|Secondary|Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period|A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of participants|||Number
27576|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|Up to Week 24|ITT population.||percentage of participants|||Number
27390|NCT01646385|Primary|Crude Incidence Rate of Lymphoproliferative Malignancy (LM)|Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as ‘lymphoproliferative malignancy’ in the field [lymphopro] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
27391|NCT01646385|Primary|Crude Incidence Rate of Malignancy|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.||events per 1000 participant-years|||Number
27392|NCT01646320|Secondary|Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis.|From baseline to week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period||Percentage of subjects|||Number
27393|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period||kg||Standard Error|Least Squares Mean
27394|NCT01646320|Secondary|Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24|2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed is the number of randomized subjects with non-missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Least Squares Mean
27395|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed corresponds to the number of randomized subjects with non-missing baseline value and at least one post-baseline value.||mg/dL||Standard Error|Least Squares Mean
27396|NCT01646320|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period.||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
27397|NCT01646268|Secondary|Change in Unified Parkinson’s Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.~The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score ranges from 0 to 108, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
27413|NCT01646255|Primary|Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period|A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication. A negative mean indicates a reduction of the time off during the conduct of the study|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||hours||Standard Deviation|Mean
33859|NCT01539538|Primary|Patient Global Satisfaction|Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control|48 hours|||% patients reporting good or excellent||95% Confidence Interval|Number
27398|NCT01646268|Secondary|Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score ranges from 0 to 52, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
27399|NCT01646268|Secondary|Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.~The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. A higher score denotes greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||percentage of responders|||Number
27400|NCT01646268|Primary|Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.~The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
27401|NCT01646255|Secondary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS Part III Motor Examination) During “on” Periods From Baseline to the End of Double-blind Maintenance Period|"The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability.~A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||units on a scale||Standard Deviation|Mean
27402|NCT01646255|Secondary|Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the off state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of days||Standard Deviation|Mean
27403|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on without troublesome dyskinesia” state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of days||Standard Deviation|Mean
27414|NCT01646177|Secondary|Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.|Baseline, Week 12|All randomized participants who received at least one dose of study treatment and had evaluable data.||Participants|||Number
27404|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on with troublesome dyskinesia” state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percentage of days||Standard Deviation|Mean
27405|NCT01646255|Secondary|Change in the Number of “Off” Periods From Baseline to the End of Double-blind Maintenance Period|A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||Number of 'off' Periods||Standard Deviation|Mean
27406|NCT01646255|Secondary|Percent Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes.~Relative time spent “on” will be calculated in two stages. Each valid daily diary will have an associated relative time “on” calculated as relative time “on” for day = 100*[total absolute time “on” for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time “on” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
27407|NCT01646255|Secondary|Percent Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
27408|NCT01646255|Secondary|Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Relative time spent “on” will be calculated in two stages. Each valid daily diary will have an associated relative time “on” calculated as relative time “on” for day = 100*[total absolute time “on” for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time “on” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||hours||Standard Deviation|Mean
27409|NCT01646255|Secondary|Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Absolute time “on” is defined as the mean number of hours marked “on” during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||hours||Standard Deviation|Mean
27410|NCT01646255|Secondary|Percent Change in Relative Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.~Relative time spent “off” will be calculated in two stages. Each valid daily diary will have an associated relative time “off” calculated as relative time “off” for day = 100*[total absolute time “off” for day/ absolute time awake for day]. Relative time spent off is then calculated by averaging the daily relative time “off” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
27411|NCT01646255|Secondary|Percent Change in Absolute Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.~Absolute time “off” is defined as the mean number of hours marked “off” during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.||percent change||Standard Deviation|Mean
27415|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
27416|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
27417|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
27418|NCT01646177|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Means in Patient's Global Assessment of Disease Severity score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of Patient's Global Assessment of Disease Severity.||Units on a Scale||Standard Error|Least Squares Mean
27419|NCT01646177|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of SF-36. Participants with missing SF-36 data were imputed by Last Observation Carried Forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
27420|NCT01646177|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The WPAI-PSO is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days. It has four domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 and ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of WPAI-PSO. Participants with missing WPAI-PSO data were imputed by Last Observation Carried Forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
27421|NCT01646177|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS Means in total QIDS-SR16 score were calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of QIDS-SR16. Participants with missing QIDS-SR16 data were imputed by Last Observation Carried Forward (LOCF) method.||Units on a Scale||Standard Error|Least Squares Mean
27577|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model.|Up to Week 24|ITT population.||percentage of participants|||Number
27422|NCT01646177|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score|PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had scalp psoriasis at baseline and had at least one post-dose measurement of PSSI.||Units on a Scale||Standard Error|Least Squares Mean
27423|NCT01646177|Secondary|Percent of Body Surface Area (BSA) Involvement of Psoriasis|Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb). LS Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of BSA.||Percent||Standard Error|Least Squares Mean
27424|NCT01646177|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had fingernail involvement at baseline and had at least one post-dose measurement of NAPSI.||Units on a Scale||Standard Error|Least Squares Mean
27425|NCT01646177|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “not at all,” “a lot,” and “very much,” with corresponding scores of 1, 2, and 3, respectively, and unanswered (“not relevant”) responses scored as “0.” Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of DLQI.||Units on a Scale||Standard Error|Least Squares Mean
27426|NCT01646177|Secondary|Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or did not follow the protocol, and had an Itch NRS score >=4 at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.||Participants|||Number
27427|NCT01646177|Secondary|Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
27428|NCT01646177|Secondary|Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
27556|NCT01644500|Secondary|Change From Baseline in Sitting Pulse Rate at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline pulse rate as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
27429|NCT01646177|Secondary|Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
27430|NCT01646177|Primary|Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
27431|NCT01646177|Primary|Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.||Participants|||Number
27432|NCT01646151|Primary|IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.|Week 12|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
27433|NCT01646151|Secondary|Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops|Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.|Week 12|All patients||Percentage of Patients|||Number
27434|NCT01646151|Secondary|Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment|Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.|12 Weeks|All patients||Percentage of Patients|||Number
27435|NCT01646151|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure||Patients|||Number
27436|NCT01646151|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure||Patients|||Number
27437|NCT01646151|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure||Patients|||Number
27438|NCT01646151|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 12|All patients with data for this outcome measure||Eyes|Participants||Number
27439|NCT01646151|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
27440|NCT01646138|Primary|Percent MMID|Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.|67 days after influenza inoculation|Analysis of the subjects who completed the study after receiving a particular dose of Ca/04/2009/H1N1 Vero Grown Challenge Virus.||percentage of participants|||Number
27441|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||scores on a scale||Standard Deviation|Mean
27442|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||scores on a scale||Standard Error|Mean
27443|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27444|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27445|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27446|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27447|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period B]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27448|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period A]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27449|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period B]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27450|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period A]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27451|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27578|NCT01644474|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
27452|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27453|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]|PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||percent change||Standard Deviation|Mean
27454|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]|Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); Last observation carried forward (LOCF): used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.||Percent change||Standard Error|Mean
27455|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|Intent to Treat Population B (ITT_B): all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27456|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3 and 7|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27457|NCT01646073|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Week 12|Intent to Treat Population A (ITT_A): all participants who were randomized at Week 0 (Baseline); Non-responder imputation (NRI): any participant who had a missing value at a specific visit as non-responder for that visit.||percentage of participants|||Number
27458|NCT01645735|Other Pre-specified|Safety Evaluation|Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs|Baseline (Day 0) to Day 49|Safety Population: all randomized subjects who received any amount of IV study drug||participants|||Number
27459|NCT01645735|Other Pre-specified|Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population|An overall microbiological outcome was derived based on the subject’s baseline pathogen. As no follow-up specimens were collected at the TOC visit for any subjects, all microbiological outcomes were derived based strictly on clinical outcomes, as either presumed eradication (ie, source specimen was not available to culture and the subject was assessed as clinical cure) , presumed persistence (ie, source specimen was not available to culture and the subject was assessed as a clinical failure), or indeterminate (ie, source specimen was not available to culture and the subject’s clinical response was assessed as indeterminate).|Test of Cure, an average of 3 weeks|mMITT Population: a subset of the MITT Population, including subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline||participants|||Number
34658|NCT01525667|Secondary|Change From Day 1 to Week 12 in Mean Fiber Diameter.|Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.|Day 1 to Week 12|||microns||Standard Error|Least Squares Mean
27460|NCT01645735|Primary|Clinical Outcome at Test of Cure (TOC) in the MITT Population|"An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:~Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required~Failure: Subjects who meet either of the following criteria:~Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy~Death in which CABP is contributory~Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:~Death in which CABP is clearly noncontributory~Lost to follow-up~Extenuating circumstances precluding classification as a cure or failure~A favorable clinical outcome at Test-of Cure (TOC) was clinical cure."|Test of Cure, an average of 3 weeks|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen)||participants|||Number
27461|NCT01645735|Primary|Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population|"Clinical response was defined as meeting all of the following criteria:~Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:~Cough~Dyspnea~Sputum production~Chest pain~Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):~Temperature ≤ 37.8°C~Heart rate ≤ 100 beats/min~Respiratory rate ≤ 24 breaths/min~Systolic blood pressure ≥ 90 mmHg~Oxygen saturation ≥ 90%~Confusion/disorientation absent"|Study Day 4|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of Community-Acquired Bacterial Pneumonia (CABP) with risk factors for Methicillin-Resistant Staphylococcus aureus (MRSA) (excluding those that have a sole atypical pathogen)||participants|||Number
27462|NCT01645709|Secondary|Number of Subjects With Adverse Events|Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator|13 weeks||||||
27463|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Rescue medication use"|13 weeks||||||
27464|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Patient Global Impression of Change (PGIC)"|13 weeks||||||
27465|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Response rate"|13 weeks||||||
27466|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Difference in the current in-clinic pain intensity using the 0-10 NRS before and after exercise at each visit"|13 weeks||||||
27467|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• In-clinic 24-hour recall pain intensity using the 0-10 numerical rating scale (NRS) at each visit"|13 weeks||||||
27468|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• WOMAC pain subscale as measured from 2 to 12 weeks post-treatment using an AUC approach"|13 weeks||||||
27469|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• WOMAC total and subscale scores for pain, function, and stiffness at each visit"|13 weeks||||||
27470|NCT01645709|Primary|Compare Efficacy of Verapmil vs Placebo at Week 4|To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.|4 weeks||||||
27471|NCT01645280|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28|The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 28|The m-ITT included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.||units on scale||Standard Error|Least Squares Mean
27472|NCT01645280|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient’s Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).|Week 12|The m-ITT population included participants who received at least 1 (partial or complete) dose of study agent.||percentage of participants|||Number
27473|NCT01645280|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28|The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|From Baseline to Week 28|The modified-ITT population included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.||units on scale||Standard Error|Least Squares Mean
27579|NCT01644474|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
27474|NCT01645280|Primary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient’s assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).|Week 28|The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.||percentage of participants|||Number
27475|NCT01645111|Primary|Time to Achieve Target MAP|The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg|First 30 minutes of infusion|||minutes||Standard Deviation|Mean
27476|NCT01645098|Secondary|EtCO2 Change After Dexmedetomidine Loading Dose|Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.|||mmHg||Standard Deviation|Mean
27477|NCT01645098|Secondary|Oxygen Saturation Change After Dexmedetomidine Loading Dose|Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.|||percentage of oxygen||Standard Deviation|Mean
27478|NCT01645098|Secondary|Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose|Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.|Baseline to immediately post dexmedetomidine infusion.|||mmHg||Standard Deviation|Mean
27479|NCT01645098|Secondary|Heart Rate Change After Dexmedetomidine Loading Dose|Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.|Baseline to immediately post dexmedetomidine infusion.|||BPM||Standard Deviation|Mean
27480|NCT01645098|Primary|Time to Sedation Score of 3-4|The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.|Immediately prior to incision|||minutes||Standard Deviation|Mean
27481|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Smoking|Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)|one day (there is no follow-up, it is a cross-sectional study)|||percentage of smoking participants|||Number
27482|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-physical Activity|Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)|one day (there is no follow-up, it is a cross-sectional study)|||percentage of patients physical activity|||Number
27483|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Age|Analyse disseminated Breast Cancer treatment and clinical profile (age)|one day (there is no follow-up, it is a cross-sectional study)|||years||Standard Deviation|Mean
27484|NCT01645059|Secondary|Adjuvant Treatment-Node Affectation|"Adjuvant treatment and clinical profile (Node affectation)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)|||percentage of patients node affectation|||Number
27485|NCT01645059|Secondary|Adjuvant Treatment-Physical Activity|"Adjuvant treatment and clinical profile (Physical activity)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)|||percentage of patients physical activity|||Number
27486|NCT01645059|Secondary|Adjuvant Treatment and Age|"Adjuvant treatment and clinical profile (age)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)|||years||Standard Deviation|Mean
27487|NCT01645059|Secondary|The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it si a cross-sectional study)|||percentage of participants|||Number
27488|NCT01645059|Secondary|Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it is a cross-sectional study)|||percentage of participants||95% Confidence Interval|Number
27489|NCT01645059|Primary|The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)|General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis|1 day (there is no follow-up, it is a cross-sectional study)|||percentage of participants||95% Confidence Interval|Number
27490|NCT01644734|Secondary|Change in the Total CAT Score (Value Baseline Minus 3 Months)|The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.|Baseline, 3 months|Patients from FAS||units on a scale||Standard Deviation|Mean
27491|NCT01644734|Primary|Number of Patients Maintaining or Improving Their Health Status|The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.|Baseline, 3 months|Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.||participants|||Number
28458|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
27492|NCT01644695|Secondary|Intra and Post-Operative Complications|Record of intra and post operative complications resulting from BARS(bony anchoring reinforcement system) procedure including but not limited to scarring, pain, numbness, intra-abdominal injury, bleeding, death, infection, anesthesia complications, and need for further surgery.|ongoing, average 2.4 years|There were 6 instances of wound dehiscence. There were 2 instances each of infection, necrosis, DVT,hematoma, and neuroma. There was 1 instance each of cellulitis, bowel obstruction, entrapped nerve, and temporary numbness. Further surgery was required 7 times, of which 3 included partial removal of the mesh. 27 complications in total.||participants|||Number
27493|NCT01644695|Primary|Recurrence Rate|Evidence of complex incisional hernia recurrence after treatment with BARS procedure.|ongoing, average 2.4 years|Subjects were chosen per protocol according to their candidacy for the BARS procedure. All patients were monitored closely following the operation.||participants|||Number
27494|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cUTI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set||NG/ML||Full Range|Geometric Mean
27495|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cIAI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set||NG/ML||Full Range|Geometric Mean
27496|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set|Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Extended microbiologically evaluable at TOC||Participant|||Number
27497|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in mMITT Analysis Set|Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Microbiological modified intent to treat||Participant|||Number
27498|NCT01644643|Secondary|The Reason for Treatment Change/Discontinuation in mMITT Analysis Set|Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl)|From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27499|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
27500|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27501|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2||Participant|||Number
27502|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1||Participant|||Number
27557|NCT01644500|Secondary|Change From Baseline in Sitting Blood Pressure at 26 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline blood pressure as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
27503|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
27504|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT||Participant|||Number
27505|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
27506|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
27507|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27508|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27509|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2||Participant|||Number
27510|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Extended microbiologically evaluable at FU1||Participant|||Number
27558|NCT01644500|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks||Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable serum calcitonin data.||picomoles per liter (pmol/L)||Standard Deviation|Mean
27511|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in EME at TOC Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
27512|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in EME at EOT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT||Participant|||Number
27513|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
27514|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
27515|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27516|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27517|NCT01644643|Secondary|Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set|Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2||Participant|||Number
27518|NCT01644643|Secondary|Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set|Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1||Participant|||Number
27519|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
27520|NCT01644643|Secondary|Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set|Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT||Participant|||Number
27521|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27522|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC||Participant|||Number
27523|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27524|NCT01644643|Secondary|Clinical Response at FU2 in EME at FU2 Analysis Set|Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended Microbiological Evaluable at FU2 analysis set.||Participant|||Number
27525|NCT01644643|Secondary|Clinical Response at FU1 in EME at FU1 Analysis Set.|Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended Microbiological Evaluable at FU1 analysis set.||Participant|||Number
27526|NCT01644643|Secondary|Clinical Response at TOC in EME at TOC Analysis Set.|Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at TOC analysis set.||Participant|||Number
27527|NCT01644643|Secondary|Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at EOT analysis set.||Participant|||Number
27528|NCT01644643|Secondary|Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
34659|NCT01525667|Secondary|Change From Day 0 to Week 26 in Muscle Volume.|Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.|Day 0 to Week 26|||mm3||Standard Error|Least Squares Mean
27529|NCT01644643|Secondary|Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat||Participant|||Number
27530|NCT01644643|Secondary|Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27531|NCT01644643|Primary|Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set|Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat||Participant|||Number
27532|NCT01644617|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an AE|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment (Up to 24 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment||Percentage of Participants|||Number
27533|NCT01644617|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment||Percentage of participants|||Number
27534|NCT01644617|Secondary|Change From Baseline in HDM-specific IgG4 Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at baseline and Week 8. IgG4 levels were expressed in Log 10 scale mg/L. Mean Week 8 IgG4 levels were compared to the mean IgG4 levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Time Frame: Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 mg/L||95% Confidence Interval|Least Squares Mean
27535|NCT01644617|Secondary|Change From Baseline in HDM-specific IgE Levels at Week 8|D. pteronyssinus and D. farinae serum IgE levels were measured using the Immunocap® assay at baseline and Week 8. IgE levels were expressed in Log 10 scale kU/L. Mean Week 8 IgE levels were compared to the mean IgE levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 kU/L||95% Confidence Interval|Least Squares Mean
27536|NCT01644617|Secondary|HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at Week 8. IgG4 levels were expressed in Log 10 scale milligrams/Liter (mg/L). Analysis was based on the ANOVA model with treatment as the fixed effect and reported as mean IgG4 with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 mg/L||Standard Deviation|Mean
27537|NCT01644617|Secondary|HDM-specific Immunoglobulin E (IgE) Levels at Week 8|Dermatophagoides pteronyssinus (D. pteronyssinus) and Dermatophagoides farinae (D. farinae) serum IgE levels were measured using the Immunocap® assay at Week 8. IgE levels were expressed in Log 10 scale kilo units/Liter (kU/L). Analysis was based on the analysis of variance parametric (ANOVA) model with treatment as the fixed effect and reported as mean IgE with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Log 10 kU/L||Standard Deviation|Mean
27538|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 8|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 8 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27539|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 16|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 16 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27540|NCT01644617|Secondary|Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 24 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27541|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 8 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27542|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 16 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27543|NCT01644617|Secondary|Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 24 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27544|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 8|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 8 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27559|NCT01644500|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable pancreatic enzyme data.||units per liter (u/L)||Standard Deviation|Mean
27560|NCT01644500|Secondary|Incidence of All Hypoglycemic Episodes|The overall number of participants with self-reported hypoglycemic episodes is presented.|Baseline through 26 Weeks|All participants who were randomized and received at least 1 dose of study drug.||participants|||Number
28459|NCT01631825|Secondary|Each Item of UPDRS Part 2 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
27545|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 16|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 16 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27546|NCT01644617|Primary|Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint||Score on a Scale||95% Confidence Interval|Least Squares Mean
27547|NCT01644500|Secondary|Visual Analog Scale (VAS) Score at Week 26|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life and consists of a 100-milliliter (mm) visual analog scale (VAS) on which the participant rated their perceived health state on that day from 0-mm (worst imaginable health state) to 100-mm (best imaginable health state).|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable VAS data.||units on a scale||Standard Deviation|Mean
27548|NCT01644500|Secondary|European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 5 response categories is summarized for each of the 5 dimensions.|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable EQ-5D data.||participants|||Number
27549|NCT01644500|Secondary|Number of Participants With Adjudicated Pancreatitis|The number of adjudicated (by an independent committee of expert physicians) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|All participants who were randomized and received at least 1 dose of study drug.||participants|||Number
27550|NCT01644500|Secondary|Number of Participants With Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs that were adjudicated included myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|Baseline through 26 Weeks|All participants who were randomized and received at least 1 dose of study drug.||number of participants|||Number
27551|NCT01644500|Secondary|Proportion of Participants Developing Antibodies to Dulaglutide|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline and 26 weeks. A participant was considered to have treatment-emergent dulaglutide ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ADA data.||percentage of participants|||Number
27552|NCT01644500|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable BMI data.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
27553|NCT01644500|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable body weight data.||kilogram (kg)||Standard Error|Least Squares Mean
27554|NCT01644500|Secondary|Change From Baseline in Heart Rate From ECG at 26 Weeks||Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ECG data.||bpm||Standard Deviation|Mean
27555|NCT01644500|Secondary|Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex.|Baseline, 26 Weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ECG data.||milliseconds (msec)||Standard Deviation|Mean
27561|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks|Change from baseline in HOMA2-%S was assessed by using the HOMA to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an ANCOVA model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.||percentage of HOMA2-%S||Standard Error|Least Squares Mean
27562|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks|Change from baseline in HOMA2-%B was assessed by using the homeostasis model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses FBG, insulin, and C-peptide concentrations to estimate steady state β-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an analysis of covariance (ANCOVA) model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
27563|NCT01644500|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 milligrams per deciliter (mg/dL) (≤3.9 mmol/L). A severe hypoglycemic episode was defined as any hypoglycemic event for which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Log mean rates of total hypoglycemia (per 30 days per participant) are presented and were calculated from negative binomial regression model. The model included country/region, prior medication group, treatment, visit, and treatment-by-visit interaction. The logarithm of days between visits was adjusted as an offset to account for possible unequal duration between visits and between participants.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, and had evaluable hypoglycemic data.||episodes/participant/30 days||Standard Error|Log Mean
27564|NCT01644500|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks|Change from baseline in mean daily blood glucose (BG) values were measured with a 7-point SMBG profile. Participants recorded their 7-point SMBG profiles on 2 separate, non-consecutive days during the 2-week period immediately before randomization, Week 8, Week 16, and Week 26 (or the Early Discontinuation Visit). The 7-point SMBG profile consisted of pre-prandial BG measures before the morning (fasting), midday, and evening meals; BG measures 2 hours after the start (post-prandial) of the morning, midday, and evening meals; and BG measures at bedtime. Mean at 26 weeks was assessed in all treatment groups. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.||mmol/L||Standard Error|Least Squares Mean
27565|NCT01644500|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|FBG is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. FBG was measured by a central laboratory. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline FBG as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
27566|NCT01644500|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks|Percentages of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.||percentage of participants|||Number
27567|NCT01644500|Primary|Change From Baseline in HbA1c at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.||percentage of HbA1c||Standard Error|Least Squares Mean
27568|NCT01644474|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.||percent change||Standard Error|Mean
27569|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on­ or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
27570|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Mean
27581|NCT01644474|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on­ or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
27582|NCT01644474|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on­ or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
27583|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on­ or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
27584|NCT01644474|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.||percent change||Standard Error|Least Squares Mean
27585|NCT01644474|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
27586|NCT01644396|Other Pre-specified|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.~The investigator rated the severity of each AE as either:~Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities.~Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening.~A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.~Drug-related AEs are those assessed by the investigator as either probably or possibly related.~Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma."|From the first dose of study drug until 70 days after the last dose (up to 33 weeks).|||participants|||Number
27587|NCT01644396|Other Pre-specified|Change From Baseline in Body Temperature|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||degrees celsius||Standard Deviation|Mean
27588|NCT01644396|Other Pre-specified|Change From Baseline in Weight|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||kg||Standard Deviation|Mean
27589|NCT01644396|Other Pre-specified|Change From Baseline in Respiratory Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||respirations per minute||Standard Deviation|Mean
27590|NCT01644396|Other Pre-specified|Change From Baseline in Pulse|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||beats per minute||Standard Deviation|Mean
27591|NCT01644396|Other Pre-specified|Change From Baseline in Blood Pressure|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|||mm Hg||Standard Deviation|Mean
27592|NCT01644396|Other Pre-specified|Change From Baseline in Urine Specific Gravity|Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||ratio||Standard Deviation|Mean
27593|NCT01644396|Other Pre-specified|Change From Baseline in Urine pH|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||pH units||Standard Deviation|Mean
27594|NCT01644396|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mg/L||Standard Deviation|Mean
27595|NCT01644396|Other Pre-specified|Change From Baseline in Triglycerides|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
27596|NCT01644396|Other Pre-specified|Change From Baseline in Cholesterol|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
27599|NCT01644396|Other Pre-specified|Change From Baseline in Glucose|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
27600|NCT01644396|Other Pre-specified|Change From Baseline in Calcium, Sodium and Potassium|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
27601|NCT01644396|Other Pre-specified|Change From Baseline in Inorganic Phosphate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
27602|NCT01644396|Other Pre-specified|Change From Baseline in Uric Acid|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||µmol/L||Standard Deviation|Mean
27603|NCT01644396|Other Pre-specified|Change From Baseline in Blood Urea Nitrogen (BUN)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mmol/L||Standard Deviation|Mean
27604|NCT01644396|Other Pre-specified|Change From Baseline in Creatinine|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||µmol/L||Standard Deviation|Mean
27605|NCT01644396|Other Pre-specified|Change From Baseline in Total Bilirubin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||µmol/L||Standard Deviation|Mean
27606|NCT01644396|Other Pre-specified|Change From Baseline in Alkaline Phosphatase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||U/L||Standard Deviation|Mean
27607|NCT01644396|Other Pre-specified|Change From Baseline in Aspartate Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||U/L||Standard Deviation|Mean
27608|NCT01644396|Other Pre-specified|Change From Baseline in Alanine Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||U/L||Standard Deviation|Mean
27609|NCT01644396|Other Pre-specified|Change From Baseline in Erythrocyte Sedimentation Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||mm/hour||Standard Deviation|Mean
27610|NCT01644396|Other Pre-specified|Change From Baseline in Blood Cell Counts|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||× 10^9 cells/L||Standard Deviation|Mean
27611|NCT01644396|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.~Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Week 24|Intent-to-treat population who had a NAPSI score ≥ 0 at the Baseline visit; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
27612|NCT01644396|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Weeks 8, 12, and 24|Intent-to-treat population with available data; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
27635|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
28460|NCT01631825|Secondary|Each Item of UPDRS Part 1|The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
27613|NCT01644396|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.~Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
27614|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 100 Response|The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder analysis was used.||percentage of participants|||Number
27615|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 90 Response|The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
27616|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 75 Response|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, and 16|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
27617|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 50 Response|The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
27618|NCT01644396|Secondary|Percentage of Participants Achieving a One Grade Improvement in Physician’s Global Assessment (PGA)|"The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a shift from Baseline to a less severe category is reported."|Baseline and Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
27619|NCT01644396|Secondary|Percentage of Participants Achieving a Physician’s Global Assessment of Clear or Minimal|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
27636|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27637|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|Up to Week 52|mITT population.||percentage of participants|||Number
27620|NCT01644396|Secondary|Percentage of Participants Achieving a Physician’s Global Assessment of Clear|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a PGA score of clear (0) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.||percentage of participants|||Number
27621|NCT01644396|Other Pre-specified|Change From Baseline in Red Blood Cell Count|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||× 10^12 cells/L||Standard Deviation|Mean
27622|NCT01644396|Other Pre-specified|Change From Baseline in Hematocrit|Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma).|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||liters/liter||Standard Deviation|Mean
27623|NCT01644396|Other Pre-specified|Change From Baseline in Hemoglobin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.||g/L||Standard Deviation|Mean
27624|NCT01644396|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 24|Intent-to-treat population; non-responder imputation (NRI) was used, where participants with a missing value were counted as a non-responders.||percentage of participants|||Number
27625|NCT01644292|Primary|Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score|The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed.|Baseline and follow-up (1 month)|||units on a scale||Standard Deviation|Mean
27626|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 – On-Treatment Analysis|Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 104|mITT population.||Percent change||Standard Error|Least Squares Mean
27627|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis|Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.|From Baseline to Week 104|ITT population.||Percent change||Standard Error|Least Squares Mean
27628|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.||Percent change||Standard Error|Least Squares Mean
27629|NCT01644188|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
27630|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27631|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
27632|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27633|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
27634|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27638|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
27639|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
27640|NCT01644188|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population||percent change||Standard Error|Least Squares Mean
27641|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
27642|NCT01644188|Secondary|Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo-B ITT population.||percent change||Standard Error|Least Squares Mean
27643|NCT01644188|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
27644|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline up to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
27645|NCT01644188|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
27646|NCT01644188|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population).||percent change||Standard Error|Least Squares Mean
27647|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population).||percent change||Standard Error|Least Squares Mean
27648|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
27649|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
27650|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL­-C at Week 24 - On­-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
27651|NCT01644188|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
27652|NCT01644175|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
27653|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27654|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
27655|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27656|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
27657|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed be robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27658|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
27659|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.||percent change||Standard Error|Mean
27660|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
27661|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
27662|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
27663|NCT01644175|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
27664|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
27665|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
27666|NCT01644175|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
27667|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
27668|NCT01644175|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
27669|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
27670|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
27671|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
27672|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
27673|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
27674|NCT01644175|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
27675|NCT01644058|Primary|Oral-health-related Quality of Life With the Immediate Loading Protocol|Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.|4 months|||units on a scale||Standard Deviation|Mean
27676|NCT01644058|Primary|Patient Satisfaction With the Immediate Loading Protocol|Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).|4 months|||millimeters||Standard Deviation|Mean
27677|NCT01643876|Secondary|Candida Species Count|Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.|3 months|||colony forming units (CFUs)||Full Range|Median
27678|NCT01643876|Primary|Palatal Inflammation|"Modified Newton classification 0: Healthy mucosa~1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation~Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue~Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue~Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index~0: Normal tissue~Mild inflammation~Moderate inflammation~Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)"|3 months|||units on a scale||Full Range|Median
27679|NCT01643798|Primary|Change in BOLD Signal in Pain Processing Regions During Pain, Including Supraspinal Opioidergic Structures|There are two experimental visits separated by one week. During each experiment, blood oxygen level dependent (BOLD) signal will be measured at baseline (60 minutes into the experiment), post-sham rTMS (90 minutes into the experiment) and post-real (120 minutes into the experiment).|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)|||mean percentage of BOLD signal change||Standard Error|Mean
27680|NCT01643798|Primary|Pain Rating|"There are two experimental visits separated by one week. During each experiment, pain ratings will be measured every 30 minutes. Preliminary testing will be done 30 minutes into the experiment. The purpose of preliminary testing is to select the temperature that will be used to induce pain throughout the experiment. Baseline testing will be done 60 minutes into the experiment. After sham rTMS will be done 90 minutes into the experiment. After real rTMS will be done 120 minutes into the study. The pain scale used in a Visual Analog Scale (VAS). There was an 11-point rating system where 0 represented no pain and 10 represented unbearable pain."|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)|||units on a scale||Standard Error|Mean
27681|NCT01643616|Primary|Success Rate With Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation"|later than 30-60 minutes after injection of the local anesthetic|||participants|||Number
27682|NCT01643616|Primary|Time Until Readiness for Surgery (Minutes)||within 60 minutes after injection of the local anesthetic|||minutes||95% Confidence Interval|Mean
27683|NCT01643616|Primary|Success Rate Without Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division"|within 30-60 minutes after injection of the local anesthetic|In the NS group two investigators were necessary in order to realize the blinded study protocol. For personnel reasons this was not possible in every case and led to deviations from the randomization protocol for seven patients in each group. These patients were excluded from the analysis.||participants|||Number
27684|NCT01643525|Secondary|Nautilus NeuroWaveTM Recording in MRI Normal Population (no Cerebrovascular Disease Per MRI)||At study completion- approximately 8 months||||||
27685|NCT01643525|Secondary|Incidence of Device Related Adverse Events||At study completion- approximately 8 months||||||
27689|NCT01643044|Primary|Alcohol Use|Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.|self-reported use during 90 days prior to delivery of their baby|||participants|||Number
27690|NCT01642914|Primary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
27691|NCT01642914|Secondary|9/12 Week Mild Straining and Diarrhea-free Responder|"A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
27692|NCT01642914|Secondary|Change From Baseline in Severity of Straining at Week 12|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is “not at all” and a value of 5 is “an extreme amount.”~A patient’s straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
27693|NCT01642914|Secondary|Change From Baseline in 12-week Severity of Straining|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is “not at all” and a value of 5 is “an extreme amount.” A patient’s straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
27694|NCT01642914|Secondary|Change From Baseline in Stool Consistency at Week 12|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]~A patient’s BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
27701|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 4|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
27695|NCT01642914|Secondary|Change From Baseline in 12-week Stool Consistency|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]~A patient’s BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
27696|NCT01642914|Secondary|Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product|"Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time).~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||Hours||95% Confidence Interval|Median
27697|NCT01642914|Secondary|SBM Within 24 Hours After the First Dose of Investigational Product|"The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|24 hours from first dose of investigational product (Day 1)|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
27698|NCT01642914|Secondary|Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM)|"A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||Days per week||Standard Deviation|Mean
27699|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 12|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
27700|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 8|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
28044|NCT01638468|Secondary|Systemic Systolic Arterial Blood Pressure|Systemic systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint.||mmHg||Standard Deviation|Mean
27702|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 1|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
27703|NCT01642914|Secondary|Change From Baseline in 12-Week SBM Frequency Rate|"A patient’s Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||SBMs per week||Standard Deviation|Mean
27704|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 12|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
27705|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 8|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
27706|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 4.|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
27707|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 1.|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
27716|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24|The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|Weeks 8 to 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.||percent of days||Standard Deviation|Mean
35688|NCT01512745|Secondary|Objective Response Rate(ORR)|Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)|30 months|||percentage of participants|||Number
27708|NCT01642914|Secondary|Change From Baseline in 12-week CSBM Frequency Rate|"A patient’s 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||CSBMs per week||Standard Deviation|Mean
27709|NCT01642914|Secondary|6/12 Week Abdominal Bloating 30% Responder|A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient’s improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
27710|NCT01642914|Secondary|Percent Change From Baseline in Abdominal Bloating at Week 12|Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12.|Baseline and Week 12|Reported outcome data is based on the 483 patient Intent-to-Treat Population. The distribution of each of the linaclotide groups was compared, in a pair-wise manner, to the placebo group using the two-sample Kolmogorov–Smirnov test.||percentage change in abdominal bloating||Standard Deviation|Mean
27711|NCT01642914|Secondary|Percent Change From Baseline in 12-week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||percentage change of NRS score||Standard Deviation|Mean
27712|NCT01642914|Secondary|Change From Baseline in 12-Week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||units on a scale||Standard Deviation|Mean
27713|NCT01642914|Secondary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population||participants|||Number
27714|NCT01642732|Secondary|Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus|Analysis of pairs of markers will be explored looking for large positive or negative correlations to indicate marker areas for further research.|Prior to treatment and at 14 days|One patient was enrolled and withdrew from the study prior to treatment. The objective was not analyzed.|||||
27715|NCT01642732|Primary|Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation||64 months after beginning everolimus|One patient was enrolled and withdrew from the study prior to treatment. The primary objective was not analyzed.|||||
27743|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 24 hrs post treatment|||percent change||95% Confidence Interval|Mean
27717|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment|Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.||percent of days||Standard Deviation|Mean
27718|NCT01642615|Secondary|Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24|Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.|From Week 8 to Week 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.||percentage of participants||95% Confidence Interval|Number
27719|NCT01642615|Secondary|Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8|Healing of EE was assessed by endoscopy.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
27720|NCT01642615|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|From Week 8 to Week 24|Safety Analysis Set included all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.||percentage of participants|||Number
27721|NCT01642615|Primary|Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|8 weeks|Safety analysis set includes all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks.||percentage of participants|||Number
27722|NCT01642602|Secondary|The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment|Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.|4 weeks|Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the efficacy variable.||Percentage of days||Full Range|Median
27723|NCT01642602|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period|A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.|4 weeks|Safety analysis set: All participants who received at least 1 dose of study drug.||Percentage of participants|||Number
27724|NCT01642589|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine|"Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set||Participants|||Number
27725|NCT01642589|Secondary|Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and 28 days post-vaccination|Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
27726|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set||Percentage of participants|||Number
27727|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set||Percentage of participants|||Number
27744|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 1 hour|||percent change||95% Confidence Interval|Mean
27728|NCT01642589|Primary|Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine|"Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).~Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level."|28 Days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set||Percentage of participants|||Number
27729|NCT01642485|Secondary|The QTcF Profile of Oral Moxifloxacin (400 mg) in Healthy Japanese Versus Caucasian Subjects||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||ms||95% Confidence Interval|Mean
27730|NCT01642485|Secondary|Insulin, Glucose and C-Peptide Effects on the QT/QTc Interval|The effect on QTc was investigated using linear mixed effect models with placebo corrected QTcF (change from average baseline) as a dependent variable and insulin, glucose and C-peptide (placebo corrected) as covariates for the data obtained under the euglycaemic clamp as well as for all data obtained under the clamp and the two types of breakfast.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||msec||95% Confidence Interval|Median
27731|NCT01642485|Secondary|Moxifloxacin 400 mg (Single Dose) Compared to Placebo on the Mean QT/QTc Interval.|"Moxifloxacin 400mg Fasted group is reporting the maximum change in QT/QTc interval from placebo treatment."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||ms||90% Confidence Interval|Mean
27732|NCT01642485|Secondary|The Food Effects (Calorie Reduced FDA Breakfast and Carbohydrate Rich Continental Style) on QTcF|"Scott et al (2002) demonstrated an increase in the heart rate of 10bpm in some healthy subjects following ingestion of a carbohydrate meal. There was significant correlation between the resultant hyperinsulinaemia and an increase in skeletal muscle blood flow, and sympathetic activity, with a reduction in vascular resistance.~If postprandial insulinaemia is a significant influence on the QT interval, then carbohydrate rich meals would be expected to show greater effect. Therefore, to explore this on two separate days of the study subjects will be given one of two different types of breakfast:~A high carbohydrate content breakfast, (>70% carbohydrate)~A reduced calorie FDA standard breakfast, (58% fat, low carbohydrate content) to determine effect on QT interval."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|||ms||90% Confidence Interval|Mean
27733|NCT01642485|Primary|The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin|The primary baseline corrections were calculated using averaged QTc baseline values (the mean of all median readings recorded for each time-point on the baseline Day -1). This single value (QTcbaselineAV) was used to calculate ΔQTc for each study period.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|Since the baseline was used as a covariate in the analysis, using the standard deviation of the change from baseline, in the simple sample size formula is justified. Assuming a standard deviation of 7 msec for the single differences, sample sizes for the sum can therefore work with a standard deviation of 6.5 msec.||ms||90% Confidence Interval|Mean
27734|NCT01642277|Secondary|Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire|"The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = Not at all to 4 = Quite a bit. From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity)."|12 weeks|Participants who received solifenacin were asked to complete the PFDI questionnaire at 12 weeks in order to assess certain bowel, bladder, and pelvic symptoms.||units on a scale||Inter-Quartile Range|Median
27735|NCT01642277|Secondary|Assessment of Overactive Bladder Questionnaire (OABQ)|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity).|End of study (Week 12)|Participants who received solifenacin were asked to complete the OABQ at 12 weeks in order to assess overactive bladder symptoms.||units on a scale||Inter-Quartile Range|Median
27736|NCT01642277|Primary|Bacterial Genomic Sequencing|Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.|12 weeks|This was a completer analysis comprising participants who completed 12 weeks of treatment (n = 50).||participants|||Number
27737|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|24-hours post-treatment|||seconds||95% Confidence Interval|Mean
27738|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|1 hr post-treatment|||seconds||95% Confidence Interval|Mean
27739|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|Pre-treatment baseline|||seconds||95% Confidence Interval|Mean
27740|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|24-hours post-treatment|||percent inhibition||95% Confidence Interval|Mean
27741|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|1 hr post-treatment|||percent inhibition||95% Confidence Interval|Mean
27742|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|Pre-treatment baseline|||percent inhibition||95% Confidence Interval|Number
27745|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 4 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 4 is rated as None, I had no pain (score=0), mild pain (score=1), moderate pain (score=2), severe pain (score=3), or very severe pain (score=4); 4 is the worst pain. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
27746|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 1 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 1 is rated as Yes (score=0) or No (score=1); higher values indicate a worse outcome. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
27747|NCT01642212|Secondary|Percent of Days That Participants Reported That They Avoided Solid Food During The Baseline And Treatment Periods|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Values were calculated for all the days that Question 1 was answered from 14 days prior to baseline visit up to the final treatment period evaluation.|From 14 days prior to the baseline visit to the final treatment period evaluation|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percentage of days||Inter-Quartile Range|Mean
27748|NCT01642212|Secondary|Percent of Participants Who Were Symptom Responders on The DSQ+Pain Scale at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Question 1 (did you eat solid food) and Question 2 (did food pass slowly or get stuck). If the answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Question 3 (did you have to do anything to make the food go down or get relief) and Question 4 (extent to which the participant experienced pain while swallowing).The DSQ+pain response was defined as a >/= 30% and >/= 50% reduction from baseline in the combined score from Questions 2, 3, and 4. The 2-week DSQ+pain score was calculated by adding points from Questions 2, 3, and 4 and then taking the average of the available scores over each 2-week interval.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27749|NCT01642212|Secondary|Percent of Participants With New Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27775|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
27776|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
27750|NCT01642212|Secondary|Percent of Participants Without Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27751|NCT01642212|Secondary|Percent of Participants With Worsened Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27752|NCT01642212|Secondary|Percent of Participants With No Change in Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27753|NCT01642212|Secondary|Percent of Participants With Improved Symptoms on The Eosinophilic Esophagitis (EoE) Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27754|NCT01642212|Secondary|Distribution of Responses For The Patient Global Impression of Change (PGIC) Survey at The Final Treatment Evaluation|Participants evaluated the change in their dysphasia (food passing slowly/difficulty swallowing) since the start of the study (screening) by choosing 1 of 7 responses on the PGIC survey: much worse (-3), worse (-2), a little worse (-1), no change (0), a little better (1), better (2), or much better (3). The values reported are the percent of participants who chose that response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27755|NCT01642212|Secondary|Change From Baseline in The Physician’s Global Assessment (PGA) of Disease Activity at The Final Treatment Period Evaluation|The physician Investigator (or qualified physician’s assistant or nurse practitioner) completed the PGA to provide the global assessment of eosinophilic esophagitis (EoE) disease activity using a 0 to 100 mm visual analog scale (VAS) scale. The VAS is a 100 mm horizontal line on which the right extreme (100) is labeled “worst possible disease activity” and the left extreme (0) is labeled “no disease activity”. The PGA raters were instructed to consider the line for the VAS a continuum with their own medical opinion or judgment of extremes on either end and to draw a vertical line at a point that best approximates the participant's current level of EoE disease activity. A negative change from baseline indicates that disease activity decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
27777|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery|It was the baseline mean blood flow velocity in middle cerebral artery.|before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
27756|NCT01642212|Secondary|Change From Baseline in The Peak Eosinophil Count at Each Available Esophageal Level at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. Baseline was defined as the score at screening. A negative change from baseline indicates that eosinophil count decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||eosinophils/HPF||Standard Error|Least Squares Mean
27757|NCT01642212|Secondary|Change From Baseline in The Total Endoscopy Score at The Final Treatment Period Evaluation|The gross endoscopic appearance of the esophageal surface was evaluated by a blinded study center physician. Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 major categories, including exudates or plaques, fixed esophageal rings, edema, furrows, and strictures. The endoscopy score was the sum of the scores for the 5 major categories – grade 0-1 for strictures; grade 0-2 for exudates or plaques, edema, and furrows; and grade 0-3 for fixed esophageal rings for the proximal and distal locations. The maximum endoscopy score was 10 points for each location (proximal and distal), and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points). Baseline was defined as the endoscopy score at screening. A negative change from baseline indicates that appearance improved.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
27758|NCT01642212|Secondary|Change From Baseline in The Histopathologic Epithelial Features Combined Total Score at The Final Treatment Period Evaluation|Each esophageal biopsy specimen was evaluated microscopically by an independent, central pathologist for signs of epithelial inflammation and lamina propria fibrosis. Histopathologic epithelial features of each available esophageal level biopsy consisting of basal layer hyperplasia, eosinophil peak, dilated intercellular spaces, eosinophil microabcesses, surface layering, surface alteration, and apoptotic epithelial cells were scored and summed. Histopathology data were collected in a blinded fashion. Histopathology epithelial features were scored for both grade and stage. Each feature had a possible score of 0-3 for grade as well as stage. Thus each of the 3 levels had a possible score of 21, and a possible total grade or stage score of 63 for a maximum combined score of 126. The grade and stage score of the lamina propria was not included because the biopsy material was not available. A negative change from baseline indicates that epithelial inflammation decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
27759|NCT01642212|Secondary|Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation|Overall response was defined as a reduction in the 2-week DSQ score of >/= 30% and >/= 50% from baseline to the final treatment period evaluation and a peak eosinophil count of </= 6/high power field (light microscopy) (HPF) across all available esophageal levels at the final treatment period evaluation. An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27760|NCT01642212|Secondary|Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27761|NCT01642212|Secondary|Percent of Participants With a Peak Eosinophil Count </= 15/High Power Field (Light Microscopy) (HPF) And </= 1/HPF at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. The values reported are for participants with histologic response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27778|NCT01642082|Secondary|Adverse Events (Primary Serious and All Other AEs)|The frequencies of the maximum grade of any serious adverse event or all other adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.|Every cycle of study treatment and after treatment for a maximum of 5 years from study entry||||||
36078|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||kilograms||Standard Deviation|Mean
27762|NCT01642212|Secondary|Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation|A cumulative distribution function curve was constructed to illustrate the cumulative proportion of participants (x-axis) vs. the change in the DSQ score from baseline to the final treatment evaluation (y-axis). The 50th percentile is participants with a DSQ score that is in the middle of the distribution of all scores. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale|||Number
27763|NCT01642212|Secondary|Change From Baseline in The DSQ Score Over Time|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8 and 12|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
27764|NCT01642212|Primary|Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||scores on a scale||Standard Error|Least Squares Mean
27765|NCT01642212|Primary|Percent of Participants Who Were Histologic Responders|Histologic response was defined as a peak eosinophil count </= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The modified Intent-to-Treat (MITT) Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.||percent of participants|||Number
27766|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
27767|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
27768|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
27769|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
27770|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||at extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
27771|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||percentage of oxygen saturation||Standard Deviation|Mean
27772|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
27773|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
27774|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.||cm/s||Standard Deviation|Mean
27780|NCT01642082|Secondary|Duration of Progression-free Survival|Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients.||months||90% Confidence Interval|Median
27781|NCT01642082|Secondary|Progression-free Survival at 6 Months|"Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.~Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for progression-free survival at 6 months."|: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients||percentage of participants||90% Confidence Interval|Number
27782|NCT01642082|Primary|Treatment and Progression-free Survival at 6 Months|"Treatment and Progression-free Survival is defined as the duration alive from study entry until progression is documented, death or non-protocol treatment is initiated; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.~Non-protocol treatment initiation prior to disease progression and prior to 6 months from study entry was counted as an event for treatment and progression-free survival at 6 months. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for treatment and progression-free survival at 6 months."|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|All eligible and treated patients||percentage of participants||90% Confidence Interval|Number
27783|NCT01642082|Primary|Response|Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be < 10 mm in short axis; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.|All eligible and treated patients||percentage of participants||90% Confidence Interval|Number
27784|NCT01642004|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||participants|||Number
27785|NCT01642004|Secondary|Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||months||95% Confidence Interval|Median
27786|NCT01642004|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||percentage of participants||95% Confidence Interval|Number
27787|NCT01642004|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||months||95% Confidence Interval|Median
27788|NCT01642004|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants||percentage of participants||95% Confidence Interval|Number
27789|NCT01642004|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CI for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)||months||95% Confidence Interval|Median
27790|NCT01642004|Secondary|Progression-Free Survival (PFS) at Primary Endpoint|PFS rate was defined as the probability that participants will experience no disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy|Randomization to 12 months post-randomization, up to November 2014|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)||percent probability of PFS||95% Confidence Interval|Number
27791|NCT01642004|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.~Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)||months||95% Confidence Interval|Median
27792|NCT01642004|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)||months||Full Range|Median
27793|NCT01642004|Primary|Overall Survival (OS) Rate in All Randomized Participants|The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 18 months post-randomization, up to June 2015|All randomized participants||percent probability of OS||95% Confidence Interval|Number
27794|NCT01642004|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||months||95% Confidence Interval|Median
27795|NCT01642004|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants||percentage of participants||95% Confidence Interval|Number
27796|NCT01642004|Other Pre-specified|Overall Survival (OS) Time in Months for All Randomized Participants at Updated Survival Follow-up|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred 7.4 months after Primary Endpoint was reached, representing a minimum OS follow-up time of 18.0 months.|Randomization until July 2015, approximately 33 months|All randomized participants||months||95% Confidence Interval|Median
27797|NCT01641991|Secondary|TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. To determine the group peak GMT, the highest titer assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of each subjects' peak titers was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||titer||95% Confidence Interval|Geometric Mean
27798|NCT01641991|Secondary|Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. A participant met the threshold of a 4-fold rise in anti-PA IgG antibody concentration if the post vaccination concentration was an increase by 4-fold or more from the baseline (Day 0) concentration.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
27799|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination and recorded oral temperatures.||participants|||Number
27800|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27801|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27802|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27803|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination.||participants|||Number
36462|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 6 months|Number of participants assessed by echocardiography (EchoCG ) at 6 months||g||Standard Deviation|Mean
27804|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27805|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27806|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27807|NCT01641991|Secondary|Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. To determine the group peak GMC, the highest antibody concentration assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of subjects' peak concentrations was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||µg/mL||95% Confidence Interval|Geometric Mean
27808|NCT01641991|Secondary|TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (0.03) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||titer||95% Confidence Interval|Geometric Mean
27809|NCT01641991|Secondary|Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)|Participants were given a ruler with the memory aid to measure the occurrence of edema (swelling) and erythema (redness) daily for at least 8 days after each vaccination. Participants are counted in this outcome measure if they had measurements of greater than 120 mm in the 8-day period after at least one vaccination, first separately for edema and erythema, and in the last category, edema and/or erythema, if they had either or both reactions of greater than 120 mm.|Days 0-7 after each vaccination|The analysis population includes all participants who were vaccinated per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27810|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month booster vaccination.||participants|||Number
27833|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2|Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015.|C1D1; C4D1|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.||mcg/mL||Standard Deviation|Mean
27811|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27812|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27813|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.||participants|||Number
27814|NCT01641991|Secondary|Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (4.64) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||µg/mL||95% Confidence Interval|Geometric Mean
27815|NCT01641991|Primary|Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.|Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
27816|NCT01641978|Secondary|Years of Professional Experience for Nurses in Critical Care|Influence of professional experience in the evaluation of neurological patients|1 year|Nurses with a minimum experience of three years in intensive care||years||Inter-Quartile Range|Median
27817|NCT01641978|Secondary|Severity in Glasgow Coma Scale (GCS) by Groups.|"The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).~Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).~It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness."|1 year|Neurological and/or neurosurgical patients in ICU||percentage of correlation||95% Confidence Interval|Number
27818|NCT01641978|Primary|Interobserver Correlation|interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) 95%|1 year|||percentage of correlation||95% Confidence Interval|Number
27819|NCT01641952|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 20|HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA). It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ the patient must have a domain score for at least 6 of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and Week 20|Intent to treat population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated to the screening exam, and have completed the baseline visit and at least one further assessment. Here, number of participant analysed is the participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
27820|NCT01641952|Primary|Number of Participants With Adverse Events (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 39 months|Safety population included all participants who received at least one dose of study treatment.||participants|||Number
27821|NCT01641952|Primary|Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline (CFB) indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||participants|||Number
27822|NCT01641952|Primary|Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
27823|NCT01641952|Primary|Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
27824|NCT01641952|Primary|Percentage of Participants With EULAR Response|The DAS28 score is a measure of the participant’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
27834|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1|Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.||nanogram per milliliter (mcg/mL)||Standard Deviation|Mean
27825|NCT01641952|Primary|Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
27826|NCT01641952|Primary|Mean DAS28-ESR Score at Visit 4 (Week 20)|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
27827|NCT01641952|Primary|Change From Baseline in DAS28-ESR at Week 20|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity [measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity]. DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline and Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||units on a scale||95% Confidence Interval|Mean
27828|NCT01641952|Primary|Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria|The DAS28 score is a measure of the participant’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.||percentage of participants|||Number
27829|NCT01641939|Secondary|Systemic Clearance (CL) - Stage 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||mL/day/kg||Standard Deviation|Mean
27830|NCT01641939|Secondary|Volume of Distribution at Steady State (Vss) - Stage 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
27831|NCT01641939|Secondary|Plasma Decay Half-Life (t1/2) - Stage 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||days||Standard Deviation|Mean
27832|NCT01641939|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1|AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.||day*mcg/mL||Standard Deviation|Mean
28046|NCT01638468|Secondary|Pulmonary Systolic Arterial Blood Pressure|Pulmonary systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participants were not evaluable.||mmHg||Standard Deviation|Mean
27835|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1|Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization.|Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
27836|NCT01641939|Secondary|Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.||months||95% Confidence Interval|Median
27837|NCT01641939|Secondary|Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 ‘Not at all’ to 4 ‘Very much’). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.||percentage of participants|||Number
27838|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3|The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 ‘Not at all’ to 4 ‘Very much’; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.||percentage of participants||95% Confidence Interval|Number
27839|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3|The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 ‘Not at all’ to 4 ‘Very much’; with the exception of the QoL/health status scale which uses a 7-point scale (1 ‘very poor’ to 7 ‘Excellent’). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.||percentage of participants||95% Confidence Interval|Number
27840|NCT01641939|Secondary|Duration of Objective Response (DOR) - Phase 3|DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this outcome measure.||months||95% Confidence Interval|Median
29662|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
27841|NCT01641939|Secondary|Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with measurable disease were included in analysis of this outcome measure.||percentage of participants||95% Confidence Interval|Number
27842|NCT01641939|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.||months||95% Confidence Interval|Median
27843|NCT01641939|Secondary|Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.||percentage participants|||Number
27844|NCT01641939|Primary|Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive.|Date of randomization until death (up to 1 year)|Analysis population included all participants that had been enrolled in phase 2 (stage 1) up to a clinical cut-off date of 10 August 2013; participants grouped according to the therapy they were randomized to receive. Here, N (number of participants analyzed)=number of evaluable participants during phase 2 up to 10 August 2013.||weeks||95% Confidence Interval|Median
27845|NCT01641939|Primary|Overall Survival (OS) - Phase 3|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until death (up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.||months||95% Confidence Interval|Median
27846|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. HBV DNA levels in blood were measured by the Roche COBAS TaqMan HBV-(High Pure System Assay). The percentage of HBeAg(+) participants with the combined response of achieving both HBeAg conversion and HBV DNA levels <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.||percentage of participants|||Number
27847|NCT01641926|Secondary|Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment|ALT normalization is a desired goal of HBV treatment, which is defined as having abnormal ALT levels at baseline and subsequently normal ALT levels after receiving treatment, where normal is defined as ≤ 1x the upper limit of normal (ULN). The percentage of HBeAg(+) and HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) and HBeAg(-) participants who received ≥1 dose of study medication.||percentage of participants|||Number
27848|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(+)participants. The percentage of HBeAg(+) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.||percentage of participants|||Number
27849|NCT01641926|Primary|Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(-) participants who received ≥1 dose of study medication. HBeAg(+) participants were not included in this analysis.||percentage of participants|||Number
27850|NCT01641926|Primary|Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment|Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not analyzed for HBeAg seroconversion.||percentage of participants|||Number
27851|NCT01641861|Secondary|Time Use for Caries Removal|The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.|Immediately while treatment|||seconds||Inter-Quartile Range|Median
27852|NCT01641861|Secondary|Levels of Pain and Discomfort|The participants were assessed for the levels of pain and discomfort using the facial visual analogue scale (VAS). The score was recorded in ruler scale from 0-100 millimeters, 0 = no pain and 100 = extreme pain) before treatment with the child sitting on the dental chair and after treatment (completion of carious tissue removal). The difference in the VAS scores before and after treatment was calculated and compared between the two comparison groups.|immediately after treatment|||Pain score from 0-100||Inter-Quartile Range|Median
27853|NCT01641861|Secondary|Number of Participants With Complete Caries Removal|The efficacy of caries removal was evaluated by the visual and tactile criteria. The completeness of caries removal was judged on the basis of clinical criteria involving the inspection of the tooth surfaces using a good light source, dental mirror and explorer. A blunt explorer was used to detect surface roughness by gently stroking across the dentine surfaces and to evaluate the dentine hardness. Complete caries removal was achieved if as remove soft and infected dentine until felt hard and leathery consistency of the dentine surfaces. The tactile criteria include the smooth passage of the blunt explorer and absence of a catch or a “tug-back” sensation.|immediately after treatment|||participants|||Number
27854|NCT01641861|Secondary|Incidence of Secondary Caries|The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.|two years|||participants|||Number
27855|NCT01641861|Primary|Number of Participants With Treatment Failure|The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).|two years|||participants|||Number
27856|NCT01641835|Primary|Bruch's Membrane Opening - Minimum Rim Area, Global||3 months|||microns^2||Standard Deviation|Mean
27857|NCT01641835|Primary|Primary Endpoints|The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.|3 months|||microns||Standard Deviation|Mean
27858|NCT01641822|Secondary|Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
27859|NCT01641822|Secondary|Rate of Hospitalizations for a Respiratory Event|The rate of hospitalizations for a respiratory event per participant year was calculated using negative binomial regression analysis.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set||hospitalizations per participant year|||Number
27860|NCT01641822|Secondary|Time to First Protocol-defined Pulmonary Exacerbation|The time to first protocol-defined pulmonary exacerbation was calculated using the Kaplan-Meier method.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set||days||95% Confidence Interval|Median
27861|NCT01641822|Secondary|Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs||Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set||percentage of participants|||Number
27862|NCT01641822|Secondary|Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex and body composition. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.||percentage of FEV1 % predicted||Standard Error|Mean
27863|NCT01641822|Primary|Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24|PDEs were characterized by a change or worsening from baseline of 1 or more documented signs or symptoms (decreased exercise tolerance, increased cough, increased sputum or chest congestion, decreased appetite, or other signs or symptoms) associated with the use of non-study IV or inhaled antibiotics and be verified by a blinded independent adjudication committee.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|Intent-to-Treat (ITT) Analysis Set: all randomized participants||PDEs per participant year|||Number
27890|NCT01641640|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
27864|NCT01641692|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Day 7 to Day 14 of Each Treatment Period|The mean number of puffs per day of rescue salbutamol at Baseline (i.e. run-in or washout data) and on-treatment were recorded. Total puffs was calculated as (Number of Puffs + (2 x number of Nebules)). Only the 7 days proceeding each treatment period were included in the Baseline calculations. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Number of puffs||Standard Deviation|Mean
27865|NCT01641692|Secondary|Change From Baseline in Mean Morning (AM) and Evening (PM) Pre-treatment Peak Expiratory Flow (PEF) Over Day 7 to Day 14 of Each Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 7 to 14 was analyzed. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; Baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Liters per minute||Standard Deviation|Mean
27866|NCT01641692|Secondary|Change in Baseline in Serial FEV1 Over 0-24 Hours After the Morning Dose on Day 14 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 was measured at 5, 15, 30 minutes (min), 1, 3, 6, 9, 12, 16, 20, 23 and 24 hours (h) post-dose. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis was preformed using a repeated measures model with terms for period, treatment, time, mean Baseline, period Baseline, and time by mean Baseline, time by period Baseline, and time by treatment interactions.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Liters||Standard Error|Least Squares Mean
27867|NCT01641692|Secondary|Change From Baseline (BL) in the Weighted Mean (WM) 0-24 Hour FEV1 Obtained Post-AM Dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from BL at a was calculated as WM at the evaluated time point minus BL. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1, and mean Baseline FEV1 as fixed effects and participant as a random effect.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
27868|NCT01641692|Primary|Number of Participants With the Indicated 24 Hour Holter Findings|Twenty-four hour Holter ECG measurements were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart’s rhythm while the monitor is worn. Following the 24-hour period, the data from the monitor were downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist. The 24-hour Holter ECG measurements were obtained at during the screening period and on Day 14 of each treatment period. The number of participants with clinically significant change (abnormal or normal) were reported.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only participants with sufficient data (at least 16 hours of recorded data) at the specified time points were analyzed.||Participants|||Number
27869|NCT01641692|Primary|Number of Participants With the Indicated Abnormal Electrocardiogram Findings|Electrocardiograph measurements performed at Screening (Visit 1) and at Day 1 and Day 14 (pre-dose, 10 minutes post-dose and 2 hours post-dose.of each treatment period). Any clinically significant findings were identified during participant monitoring.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Participants|||Number
27870|NCT01641692|Primary|Urine Specific Gravity on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Day 14. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney’s ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
27871|NCT01641692|Primary|Urine pH on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine pH by dipstick method at Day 14. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
27891|NCT01641640|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.|Baseline to Week 12|Full Analysis Set||percentage of participants|||Number
27892|NCT01641640|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Posttreatment Week 24|Full Analysis Set||percentage of participants|||Number
27872|NCT01641692|Primary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period|Urinalysis parameters included: Urine Bilirubin (UB), Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Nitrite (UN), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace (T), 1+, 2+, and 3+, and for UG the result can be read as Neg, T, T or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, T, 1+, 2+ and 3+ levels at Day 14.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Participants|||Number
27873|NCT01641692|Primary|Change From Baseline in Hematocrit on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Proportion of red blood cells in blood||Standard Deviation|Mean
27874|NCT01641692|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils (neut) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Percentage of cells in blood||Standard Deviation|Mean
27875|NCT01641692|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - Absolute neutrophil [neut] count), platelet, and leucocytes count at Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
27876|NCT01641692|Primary|Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of chloride, caron dioxide, glucose, potassium, sodium, and urea/BUN at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Micromoles/Liter (µM/L)||Standard Deviation|Mean
27877|NCT01641692|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of direct bilirubin, indirect (ind) bilirubin, total bilirubin, and creatinine at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Micromoles/Liter (µM/L)||Standard Deviation|Mean
27878|NCT01641692|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CK, GGT, and LDH at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||International Units/Liter (IU/L)||Standard Deviation|Mean
27879|NCT01641692|Primary|Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."||Grams per liter (G/L)||Standard Deviation|Mean
27880|NCT01641692|Primary|Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period|Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Beats per minute||Standard Error|Least Squares Mean
27881|NCT01641692|Primary|Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
27882|NCT01641692|Primary|Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included systolic blood pressure (SBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
27883|NCT01641692|Primary|Number of Participants With Asthma Exacerbations During the Treatment Period|Worsening of asthma symptoms is monitored throughout the study. Severe exacerbation (deterioration of asthma requiring use of systemic corticosteroids for 3 days, inpatient hospitalization or emergency department visit due to asthma) is an exclusion criterion and requires withdrawal from the study. Asthma symptoms were assessed daily using an electronic diary throughout study.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
27884|NCT01641692|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of SAEs.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population||Participants|||Number
27885|NCT01641692|Primary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1 and mean Baseline FEV1 as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Day 15 of each treatment period (up to Study Day 71)|ITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.||Liters||Standard Error|Least Squares Mean
27886|NCT01641692|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|Dose-response was conducted for both QD and BID UMEC doses on trough FEV1 (measure of lung function, defined as the maximal amount of air that can be forcefully exhaled in 1 second) on D 15. Total daily dose of UMEC was used in the modeling. The null model was the final model. The null model is defined as: CFEV1,ij=(THETA1+ETA1j)*meanBL+(THETA2+ETA1j)*periodBL+EPSij, where CFEV1,ij represents the change from BL in trough FEV1 for participant j measured at period i. THETA1 and THETA2 were the slopes with respect to meanBL and periodBL, respectively. Omegas were the variance of the slopes on meanBL and periodBL (ETA1j, ETA2j) for each participant and Sigma was the variance of the residual errors (EPSij). MeanBL is the mean of the Baseline (BL) which is the FEV1 value recorded pre-dose on D 1 of each TP; periodBL is the difference between the BL and the meanBL in each TP for each participant.|Day 15 of each treatment period (up to Study Day 71)|Intent-To-Treat (ITT) Population: : all participants randomized to treatment and who received at least one dose of study medication. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.||unitless||95% Confidence Interval|Geometric Mean
27887|NCT01641653|Secondary|Percent Intra-op Blood Glucose Level of 140mg/dL or Less|blood glucose level will be tested perioperatively at 30 minute intervals following induction. All glucose levels will be recorded .midazolam group will maintain a blood glucose level perioperatively of 140mg/dL or less|perioperatively|||percentage of glucose levels<140|||Number
27888|NCT01641653|Secondary|Glucose Level Percent Change From Pre-op to Maximum Glucose Level|blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min|Preoperatively, intraoperatively 30 min for duration of surgery|per protocol||percentage of increase in glucose level||Inter-Quartile Range|Median
27889|NCT01641653|Primary|Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements|Non diabetic subjects undergoing hernia repair were randomized into 2 groups. Midazolam vs. placebo. Blood glucose level was monitored preoperatively and following induction of anesthesia at 30 minute intervals perioperatively, and after in the PACU at 30 minutes and 60 minutes following arrival. All readings were performed using the Abbott Freestyle Glucose Monitor.|every 30 min for duration of surgery|per protocol||mg/dL||Inter-Quartile Range|Median
27893|NCT01641640|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Posttreatment Week 4|Full Analysis Set||percentage of participants|||Number
27894|NCT01641640|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.|Baseline to Week 12|Safety Analysis Set||participants|||Number
27895|NCT01641640|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.|Posttreatment Week 12|Full Analysis Set||percentage of participants|||Number
27896|NCT01641471|Secondary|Clinical Outcomes (Functional & General Health)|Measured from modified KOOS and SF-12 v2 questionnaires.|Within 30 days before surgery, 2 weeks (+/- 3 days) after surgery, 4 weeks (+/- 3 days) after surgery, 6 weeks (+/- 3 days) after surgery||||||
27897|NCT01641471|Secondary|Functional Assessments|Measured from ROM measurement and timed up and go (TUG) test.|Within 30 days before surgery, daily during hospital stay (an expected average of 4 days), 2 weeks (+/- 3 days) after surgery, 4 weeks (+/- 3 days) after surgery, 6 weeks (+/- 3 days) after surgery||||||
27898|NCT01641471|Secondary|Visual Analog Pain Score (VAS)||Within 30 days before surgery, daily during hospital stay (an expected average of 4 days), 2 weeks (+/- 3 days) after surgery, 4 weeks (+/- 3 days) after surgery, 6 weeks (+/- 3 days) after surgery||||||
27899|NCT01641471|Primary|Narcotic Usage|Measured as the amount of pain medication and equianalgesic equivalents to morphine.|Through 6 weeks after surgery|||morphine equivalents||Standard Deviation|Mean
27900|NCT01641237|Secondary|Enamel Fluoride Uptake (Corrected Data)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. Data analysis for this outcome measure was performed based on a correction factor.||micrograms*F/centimeters^2||Standard Error|Mean
27901|NCT01641237|Secondary|Percentage Relative Erosion Resistance|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.||% Relative Erosion Resistance||Standard Error|Mean
27902|NCT01641237|Secondary|%SMHR|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.||%SMHR||Standard Error|Mean
27903|NCT01641237|Primary|Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|Per protocol population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.||%SMHR||Standard Error|Mean
27904|NCT01641159|Secondary|Cocaine-use Days|Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation|study week 16|All randomized participants||proportion of cocaine use days|||Number
27905|NCT01641159|Primary|Maximum Days of Continuous Cocaine Abstinence|The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.|study week 16|||Days||Standard Deviation|Mean
27906|NCT01641120|Secondary|Perception of Needle|"Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree).~A total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle."|Weeks 2, 3, 4, 5|||units on a scale||Standard Deviation|Mean
27918|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.||L/min||95% Confidence Interval|Mean
27907|NCT01641120|Primary|Visual Analog Scale Score for Post-injection Pain|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size."|Weeks 2, 3, 4, 5|||cm||Standard Deviation|Mean
27908|NCT01641120|Secondary|Fear of Injection|"Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never).~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle."|Weeks 2, 3, 4, 5|||units on a scale||Standard Deviation|Mean
27909|NCT01641120|Primary|Change in Patient Visual Analog Scale Score for Pre-injection Anxiety|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size."|Weeks 2, 3, 4, 5|||cm||Standard Deviation|Mean
27910|NCT01641081|Secondary|Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)|AUC0-6 is area under the curve from time 0 to 6 hours Change from baseline was baseline of Period 1|Day 1 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
27911|NCT01641081|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)|Change from baseline was baseline of each treatment period|Day 14 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
27912|NCT01640964|Secondary|Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin|This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study.|4 weeks|Safety assessment happened on full analysis set which included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.||Patients|||Number
27913|NCT01640964|Secondary|Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)|Portal vein pressure was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).|Baseline, 120 min post infusion|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and this time point are included.||mmHg||95% Confidence Interval|Mean
27914|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
27915|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
27916|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
27917|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included||L/min||95% Confidence Interval|Mean
27919|NCT01640964|Primary|Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)|"Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP).~Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion)."|Baseline, 120 min post-infusion start|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period.Only patients with a value at both baseline and this time point are included.||mmHg||95% Confidence Interval|Mean
27920|NCT01640964|Primary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post serelaxin infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.||L/min||95% Confidence Interval|Mean
27921|NCT01640925|Secondary|Number of Patients With In-hospital Mortality||up to 28 days or until first hospital discharge||||||
27922|NCT01640925|Secondary|ICU Length of Stay in Days|Number of days in the ICU after enrollment in study until first ICU discharge.|up to 28 days||||||
27923|NCT01640925|Secondary|Blood Culture Contamination Rate||up to 28 days||||||
27924|NCT01640925|Secondary|Incidence of Skin Irritation|The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.|up to 28 days||||||
27925|NCT01640925|Primary|Incidence of Nosocomial Infection|"Proportion of patients with one or more incident nosocomial infections.~Primary Efficacy Endpoints* (Composite of new nosocomial infection)~Primary Bloodstream Infection~Catheter Related Urinary Tract Infection~Ventilator-Associated Pneumonia**~Surgical Site Infection~(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints.~(**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation."|Up to 28 days|||participants|||Number
27926|NCT01640548|Secondary|Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA||9 months|"Included participants who were treated with a bDMARD with concomitant traditional DMARD as previous treatment for RA. n is the number of participants who received particular bDMARD as previous RA treatment."||months||Full Range|Median
27927|NCT01640548|Secondary|Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA||9 months|"Included participants treated with a bDMARD monotherapy as previous treatment for RA prior to switch to current bDMARD monotherapy. n is the number of participants who received particular bDMARD as previous RA treatment."||months||Full Range|Median
27928|NCT01640548|Secondary|Duration of Treatment With the Current bDMARD Usage in Monotherapy||9 months|"Included all participants who received bDMARD monotherapy as their current treatment for RA. n is the number of participants who received that particular bDMARD as their current RA treatment."||months||Full Range|Median
27929|NCT01640548|Primary|Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy|Both previous and current bDMARDs were presented together for each subgroup, therefore the percentage of participants under each reason did not add up to 100%.|9 months|Included all participants who entered the retrospective chart review.||percentage of participants||95% Confidence Interval|Number
27930|NCT01640548|Secondary|Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). TJC and SJC assessed as part of the DAS28 outcome measure assessment were reported.|9 months|"Includes all participants who were evaluable for this outcome. n represents the number of participants who were evaluable for that particular assessment."||joints count||95% Confidence Interval|Mean
27931|NCT01640548|Primary|Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment|All corticosteroids and non-steroidal anti-inflammatory drugs taken as previous and current treatments for RA were coded according to the Roche international non-proprietary name dictionary.|9 months|Included all the participants who entered the retrospective chart review.||percentage of participants|||Number
27932|NCT01640548|Secondary|Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56 x square root (√) of TJC + 0.28 x √(SJC) + 0.70 x log natural (ESR) + 0.014 x global assessment of RA score. The formula for calculating DAS28 score using CRP value is: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log natural (CRP+1) + 0.014 x global assessment of RA score +0.96. The DAS28 score range was 0-9.4 where higher scores represented higher disease activity.|9 months|"Included the number of participants who were evaluable for DAS28 assessment. n represents the number of participants who were evaluable for that particular assessment."||scores on a scale||95% Confidence Interval|Mean
27933|NCT01640548|Primary|Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs in monotherapy as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who received bDMARD as monotherapy as previous treatment prior to switch to bDMARD monotherapy as current treatment.||percentage of participants|||Number
27934|NCT01640548|Primary|Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs with concomitant traditional DMARD as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who were previously treated with any bDMARD with concomitant traditional DMARD prior to switch to bDMARD monotherapy as current RA treatment.||percentage of participants|||Number
27935|NCT01640548|Primary|Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD|Traditional DMARDS for RA treatment include methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, azathioprine, chlorambucil, mercaptopurine, and mycophenolate mofetil medications. Previous RA treatment included all the treatments received prior to switching to current RA treatment.|9 months|Included all the participants who took any past traditional DMARDs.||percentage of participants|||Number
27936|NCT01640548|Primary|Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Current bDMARDs were defined as those with a start date on or after the date of collection, or those with a start date before the date of collection and an end date on or after the date of collection. NICE guidelines recommend the participants with severe active RA who inadequately responded to prior DMARD treatment (trial of 2 DMARDs, one which includes methotrexate) and were intolerant to methotrexate or the treatment with methotrexate considered inappropriate be treated with a biologic DMARD monotherapy.|9 months|Included all the participants who entered the retrospective chart review.||percentage of participants|||Number
27937|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|From time 0 to 120 hours|||percentage of participants|||Number
27938|NCT01640340|Secondary|Use of Rescue Medication for Each Treatment Arm||From time 0 to 120 hours|||percentage of participants|||Number
27939|NCT01640340|Secondary|Visual Analog Scale (VAS) Scores||Up to 7 days after completion of study treatment|VAS Scores were not collected|||||
27940|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|Time 0 to 120 hours|||percentage of participants|||Number
27941|NCT01640340|Secondary|Delayed CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.|24-120 hours after chemotherapy|||percentage of participants|||Number
27942|NCT01640340|Secondary|Acute CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.|0-24 hours after chemotherapy|||percentage of particpants|||Number
27943|NCT01640340|Primary|Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication|We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.|Up to 120 hours after completion of chemotherapy|||percentage of patients||95% Confidence Interval|Number
27944|NCT01640327|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIVf vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Subjects|||Number
27945|NCT01640327|Primary|Percentage of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVf vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or >60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages of Subjects||95% Confidence Interval|Number
27946|NCT01640327|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer was >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
27959|NCT01640197|Primary|Chronic Modulation of Cerebral Blood Flow|Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28.|40- 80 minutes post- dose on day 28 of supplementation|Participants were included in the analysis if they provided full NIRS readings on session 1 and session 2.||Participants|||Number
27960|NCT01640184|Secondary|Changes of Blood Levels on Bone Specific Alkaline Phosphatase.|The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||microgram/L||Standard Deviation|Mean
27947|NCT01640327|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI antigen assay.~As per the European (CHMP) criteria seroconversion or significant increase in titer was defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer.~This criterion was met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or >30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of Subjects||95% Confidence Interval|Number
27948|NCT01640314|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 22 after receiving one dose of TIVc.|Day 1 to Day 22|Analysis was done on the safety set population.||Number of Subjects|||Number
27949|NCT01640314|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after TIVc vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
27950|NCT01640314|Primary|Percentages of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVc vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages||95% Confidence Interval|Number
27951|NCT01640314|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
27952|NCT01640314|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI cell-derived antigen assay.~As per the European (CHMP) criteria, seroconversion or significant increase in titer is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion is met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages||95% Confidence Interval|Number
27953|NCT01640197|Secondary|Number of Participants With Significant Modulation of CBF in MCA|CBF was assessed in the middle cerebral artery (MCA) with Trans-cranial doppler via a trans- temporal acoustic window. Participants were deemed to have significant modulation of CBF in the MCA if readings differed significantly from those obtained on day 1 (baseline).|28 days|All participants who were part of the TCD component, who could provide a consistent blood flow trace, were included in the analysis.||Participants|||Number
27954|NCT01640197|Secondary|Number of Participants With Significant Modulation of Blood Pressure|Participants were deemed to have significant modulation of blood pressure if their readings on day 28 differed significantly from that taken on day 1 (baseline).|28 days|All participants who provided all BP readings across the study were included in the analysis.||Participants|||Number
27955|NCT01640197|Secondary|Number of Participants With Significant Modulation of Health|Subjective perceptions of health were assessed with the General Health Questionnaire. Participants were deemed to have significant modulation of health if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from day 1 (baseline) completion.|Day 28|Participants were included in the analysis if they had completed questionnaires correctly.||Participants|||Number
27956|NCT01640197|Secondary|Number of Participants With Significant Modulation of Sleep|Subjective perception of sleep quality was assessed with the PSQI. Participants were deemed to have significant modulation of sleep if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from those on day 1 (baseline).|Day 28|All participants who completed their questionnaires correctly were included in the analysis.||Participants|||Number
27957|NCT01640197|Secondary|Number of Participants With Modulated Cognitive Performance|Cognitive performance was assessed by a range of cognitively demanding tasks on day 28 of the supplementation period. Participants were deemed to have significant modulation of cognitive performance if their scores on these tasks were significantly different from scores taken on day 1.|28 days|All participants who properly completed all repetitions of all tasks on both days were included in the analysis.||Participants|||Number
27958|NCT01640197|Secondary|Number of Participants With Modulated Mood|Subjective mood was assessed with the Profile of mood states (POMS) questionnaire every 7 days during the 28- day period. Participants were deemed to have significant modulation of mood if their scores on week 1, week 2, week 3 and/or week 4 differed significantly from scores on the baseline questionnaire completed on day 1.|28 days|Participants were included in the final analysis if they had completed all questionnaires correctly.||Participants|||Number
27961|NCT01640184|Secondary|Changes of Blood Levels on iPTH During 12 Months.|The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months|||ng/ml||Standard Deviation|Mean
27965|NCT01640184|Primary|Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.|The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.|12 months|Number of participants analyzed is the number of patients completed study.||percentage of participants|||Number
27966|NCT01640171|Secondary|Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection|The patient was asked to compare the two eyes in the way described in the study protocol on a five point scale. If one eye hurt a lot more or a little more than the other or if the two eyes were equal (neither hurt more than the other).|24 hours|total group||participants|||Number
27967|NCT01640171|Secondary|Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection|Pain was rated on a 10 point standardized pain scale, zero was the least pain and 10 was the worst pain. The patient was questioned using a script and shown a pain scale as well as told how the pain scale worked. Then the patient gave the number that characterized their pain.|24 hours|All patients in the study||participants|||Number
27968|NCT01640171|Primary|Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit|Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.|up to 6 months|||participants|||Number
27969|NCT01640054|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event|Entry in extension to study termination (variable duration; maximum 52 weeks)|The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.||Percentage of patients|||Number
27970|NCT01640054|Secondary|SF-36 Score Over Time|n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey|Every 12 weeks for one year then yearly until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
27971|NCT01640054|Secondary|HAQ-DI Score Over Time|HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
27972|NCT01640054|Secondary|DAS28-CRP Score Over Time|CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
27973|NCT01640054|Secondary|Components of ACR Response Criteria Over Time|ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.|||||
27974|NCT01639833|Secondary|Hemostasis at All Treated Bleeding Sites Within 3 Minutes|The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.||percentage of participants||95% Confidence Interval|Number
27975|NCT01639833|Primary|Time to Hemostasis (TTH)|Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.||minutes||95% Confidence Interval|Median
27976|NCT01639755|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.||percentage of participants|||Number
27977|NCT01639755|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body’s response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Participants from the Full Analysis population with data available for analysis.||percentage of participants|||Number
27978|NCT01639755|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
27979|NCT01639755|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
27980|NCT01639755|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
27981|NCT01639742|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.||percentage of participants|||Number
28045|NCT01638468|Secondary|Change in Systemic Systolic Arterial Blood Pressure|Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||mmHg||Standard Deviation|Mean
27982|NCT01639742|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body’s response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Full analysis population included all participants.||percentage of participants|||Number
27983|NCT01639742|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
27984|NCT01639742|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
27985|NCT01639742|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.||score on a scale||Standard Deviation|Mean
27986|NCT01639729|Primary|CST 1/2|time for maximum plasma concentration to decrease by 50%|24 hours|The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: CST½ (n=16).||hours||Full Range|Median
27987|NCT01639729|Primary|Tmax|time to maximum plasma concentration|24 hours|||hours||Full Range|Median
27988|NCT01639729|Primary|Cmax|maximum plasma concentration|24 hours|||pg/mL||Standard Deviation|Mean
27989|NCT01639729|Primary|AUC (0 - Inf)|total amount of sufentanil absorbed|24 hours|A The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: AUC 0-inf (n=18).||h.pg/mL||Standard Deviation|Mean
27990|NCT01639560|Secondary|Prolonged Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|24 weeks|||participants|||Number
27991|NCT01639560|Secondary|Point Prevalence Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.|24 weeks|||participants|||Number
27992|NCT01639560|Primary|Prolonged Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|12 weeks|||participants|||Number
27993|NCT01639560|Primary|Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.|12 weeks|||participants|||Number
27994|NCT01639443|Secondary|Cost Comparisons|For cost comparisons, the investigators will aggregate total provider overtime costs for colonoscopies performed. Cost is reported per day.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||dollars||Standard Deviation|Mean
27995|NCT01639443|Secondary|Length of Workday|Length of Workday in hours (comparing days with Fast-Tracked Appointments to Control days without)|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||hours||Standard Deviation|Mean
27996|NCT01639443|Secondary|Advanced Adenoma Detection/Cecal Intubation Rates|The investigators will compare daily advanced adenomatous polyp detection and daily cecal intubation rates between groups.|After 20 months of running study in clinic|We only collected data on polyp detection for the first half of our Fast-tracked participants and all Controls seen over the same time period (4897 in total).||Number of Polyps Detected per patient||Standard Deviation|Mean
27997|NCT01639443|Secondary|"Daily Service Denials (Bumps)"|The investigators will compare the number of patients bumped per day between scheduling approaches|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||participants|||Number
27998|NCT01639443|Secondary|Scheduling-to-procedure Lag Time|The investigators will calculate the mean daily lag time for all colonoscopy and upper endoscopies performed per day|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||days||Standard Deviation|Mean
28011|NCT01639157|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
30888|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with mutant huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population||ratio||Standard Deviation|Mean
27999|NCT01639443|Primary|Percentage of GI Clinic Capacity Filled|Investigators' primary objective will be to evaluate the impact of no-show predictive overbooking on percentage of the GI endoscopy clinic that are filled on a given day. Days where at least one Fast-tracked patient attended an appointment were compared to days where only Control patients attended appointments. Percentage of GI Clinic Capacity is calculated as the number of appointments completed divided by number of appointment spots available on a given day. This percentage was compared between Fast-tracked days and Control days, using data from 1672 patients.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.||percentage of clinic capacity filled||Standard Deviation|Mean
28000|NCT01639222|Secondary|Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)|To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.|Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose|PK/PD set||liters||Standard Deviation|Mean
28001|NCT01639222|Primary|Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum|The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.|Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.|PK/PD set||h*pg/mL||Standard Deviation|Mean
28002|NCT01639222|Primary|Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)|Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.|Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Set included all enrolled subjects who received at least one dose of the mock treatment who had reliable values of either the primary PK parameter Ca2+ Ae0-6h in both periods or the primary PD parameter PTH AUC0-6h in both periods.||mmol||Standard Deviation|Mean
28003|NCT01639157|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||beats per minute||Standard Error|Mean
28004|NCT01639157|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||mmHg||Standard Error|Mean
28005|NCT01639157|Secondary|Peak Oral Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||Degrees Fahrenheit||Standard Error|Mean
28006|NCT01639157|Secondary|"Peak Ratings of Talkative, Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative, Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28007|NCT01639157|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28008|NCT01639157|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28009|NCT01639157|Secondary|"Peak Ratings of Sluggish, Fatigued, Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish, Fatigued, Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28010|NCT01639157|Secondary|"Peak Ratings of Shaky, Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky, Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
31109|NCT01586364|Primary|Change From Baseline in FSH and LH Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||IU/L||Standard Deviation|Mean
28012|NCT01639157|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28013|NCT01639157|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28014|NCT01639157|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28015|NCT01639157|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28016|NCT01639157|Secondary|"Peak Ratings of Nervous, Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous, Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28017|NCT01639157|Secondary|"Peak Ratings of Nauseated, Queasy, Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated, Queasy, Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28018|NCT01639157|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28019|NCT01639157|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28020|NCT01639157|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28021|NCT01639157|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28022|NCT01639157|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28043|NCT01638468|Secondary|Change in Heart Rate|Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 2 participants were not evaluable.||beats per minute||Standard Deviation|Mean
28023|NCT01639157|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28024|NCT01639157|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28025|NCT01639157|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitary units on a Visual Analog Scale||Standard Error|Mean
28026|NCT01639157|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitrary units on a Likert-type scale||Standard Error|Mean
28027|NCT01639157|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||mmHg||Standard Error|Mean
28028|NCT01639157|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.|||arbitrary units on a Likert-type scale||Standard Error|Mean
28029|NCT01639157|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her 2 week inpatient admission|||Number of Cocaine Choices||Standard Error|Mean
28030|NCT01639144|Primary|Postoperative Infection and Delayed Wound Healing.|Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).|Infection: 30 days after surgery. Delayed wound healing: 60 days.|Patients have foot and/or ankle surgery.||participants|||Number
28031|NCT01638507|Secondary|Clinical Endpoint: Bleeding Complications in General||12 months|||percentage of bleeding complications|||Number
28032|NCT01638507|Secondary|Clinical Endpoint: Stroke||12 months|||percentage of strokes|||Number
28033|NCT01638507|Secondary|Clinical Endpoint: ST||12 months|||percentage of ST|||Number
28034|NCT01638507|Secondary|Clinical Endpoint: MI||12 months|||percentage of MIs|||Number
28035|NCT01638507|Secondary|Clinical Endpoint: TVR||12 months|||percentage of TVR|||Number
28036|NCT01638507|Secondary|Clinical Endpoint: TLR||12 months|||percentage of TLR|||Number
28037|NCT01638507|Secondary|Dual Antiplatelet Therapy (DAPT) Compliance||12 months|||percentage of compliance|||Number
28038|NCT01638507|Secondary|Clinical Endpoint: Death||12 months|||percentage of death|||Number
28039|NCT01638507|Secondary|Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI||12 months|||percentage of composite|||Number
28040|NCT01638507|Primary|Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)||12 months|The primary analysis set was the Intent-To-Treat (ITT) population, defined as all patients who signed the written informed consent and were enrolled in the study.||percentage of composite||95% Confidence Interval|Number
28041|NCT01638468|Secondary|Procedure Related Adverse Event Rate|Number of procedure related adverse events occurring within 3 months of the index procedure|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||events|||Number
28042|NCT01638468|Secondary|Vasopressor Support|Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||percentage of participants|||Number
30740|NCT01592760|Secondary|Device Use Time (Min)|Device Use Time is the time recorded to the nearest minute of the period bounded by the time the device placement was determined to be adequate in the study subject to its withdrawal from the study subject.|End of Device Use Time|||minutes||Standard Deviation|Mean
28047|NCT01638468|Secondary|Change in Systolic Pulmonary Arterial Blood Pressure|Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participant was not evaluable.||mmHg||Standard Deviation|Mean
28048|NCT01638468|Secondary|Death - Cardiac Cause|Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||participants|||Number
28049|NCT01638468|Secondary|Death - All Cause|Number of participant deaths due to any reason occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||participants|||Number
28050|NCT01638468|Secondary|Technical Success|Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||percentage of participants|||Number
28051|NCT01638468|Primary|Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography|The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.|Baseline to 24-48 hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint||ratio||Standard Deviation|Mean
28052|NCT01638312|Primary|Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform|"This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection.~1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units.~σ≧10 abnormal positive (+) σ＜10 normal negative (-)"|Participants provided urine samples once|||participants|||Number
28053|NCT01638000|Secondary|Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
28054|NCT01638000|Secondary|Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
28055|NCT01638000|Secondary|Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit|A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to final visit (up to Week 12)|FAS population. LOCF was used.||percentage of participants|||Number
28056|NCT01638000|Secondary|Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12|A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to Week 12|FAS population.||percentage of participants|||Number
28057|NCT01638000|Secondary|Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
28058|NCT01638000|Secondary|Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
28059|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient’s Assessment of Treatment Satisfaction Questionnaire-Likert Scale|"The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
28060|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)|"The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
28071|NCT01638000|Secondary|Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28061|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)|The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants’ perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
28062|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q|The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
28063|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
28064|NCT01638000|Secondary|Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
28065|NCT01638000|Secondary|Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
28066|NCT01638000|Secondary|Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
28067|NCT01638000|Secondary|Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
28068|NCT01638000|Secondary|Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.||participants|||Number
28069|NCT01638000|Secondary|Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28070|NCT01638000|Secondary|Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28109|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012|||events per 100,000 person years||95% Confidence Interval|Number
30781|NCT01592071|Primary|Body Mass Index|Measure of body composition: height and weight to assess BMI.|30, 60 and 90 days from baseline|||kg/m^2||Standard Deviation|Mean
28072|NCT01638000|Secondary|Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28073|NCT01638000|Secondary|Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28074|NCT01638000|Secondary|Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28075|NCT01638000|Secondary|Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28076|NCT01638000|Secondary|Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28077|NCT01638000|Secondary|Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28078|NCT01638000|Secondary|Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28079|NCT01638000|Secondary|Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28080|NCT01638000|Secondary|Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28081|NCT01638000|Secondary|Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28082|NCT01638000|Secondary|Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.||participants|||Number
28110|NCT01637935|Primary|Incident Diagnosis of Bladder Cancer (10-year Analysis)|Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.|January 1, 1997 to December 31, 2012|All participants.||events per 100,000 person years||95% Confidence Interval|Number
30782|NCT01592071|Secondary|Blood Pressure|Systolic and diastolic blood pressure measured.|30, 60 and 90 days from baseline|||mm Hg||Standard Deviation|Mean
30783|NCT01592071|Primary|Weight (kg)|Measure of body composition: weight (kg).|30, 60 and 90 days from baseline|||kilograms||Standard Deviation|Mean
28083|NCT01638000|Secondary|Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire|The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who have non-missing values at both Baseline and specified visit.||participants|||Number
28084|NCT01638000|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
28085|NCT01638000|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.||percentage of participants|||Number
28086|NCT01638000|Secondary|Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint.||percentage of participants|||Number
28087|NCT01638000|Secondary|Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||nocturia episodes||Standard Error|Least Squares Mean
28088|NCT01638000|Secondary|Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||nocturia episodes||Standard Error|Mean
28089|NCT01638000|Secondary|Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment|The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8 , Week 12|FAS population. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.||pads||Standard Error|Least Squares Mean
28090|NCT01638000|Secondary|Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit|The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.||pads||Standard Error|Mean
28091|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency|Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point.||units on a scale||Standard Error|Least Squares Mean
28092|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point.||urgency episodes||Standard Error|Least Squares Mean
28093|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||urgency incontinence episodes||Standard Error|Least Squares Mean
28129|NCT01637246|Secondary|Percentage of Patients Who Maintained Better Compliance With Treatment|Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
28094|NCT01638000|Secondary|Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.||urgency incontinence episodes||Standard Error|Mean
28095|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. N is the number of participants with available data at each time point.||incontinence episodes||Standard Error|Least Squares Mean
28096|NCT01638000|Secondary|Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point.||incontinence episodes||Standard Error|Mean
28097|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours||Baseline and Week 4, Week 8, Week 12|Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point.||micturitions||Standard Error|Least Squares Mean
28098|NCT01638000|Secondary|Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period|A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).|From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)|SAF population||percentage of participants|||Number
28099|NCT01638000|Primary|Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and final visit (up to Week 12)|Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used.||micturitions||Standard Error|Least Squares Mean
28100|NCT01637961|Other Pre-specified|Aurora A Kinase Expression|Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).|Up to 5 years||||||
28101|NCT01637961|Secondary|PFS|Characterized graphically and using descriptive statistics such as median survival.|Up to 5 years||||||
28102|NCT01637961|Secondary|Adverse Events as Assessed by NCI CTCAE Version 4.0|Toxicities will be tabulated by severity and frequency.|Up to 5 years||||||
28103|NCT01637961|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
28104|NCT01637961|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for the first 6 months; then every 3 months thereafter until withdrawal from study treatment or disease progression is confirmed.|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
28105|NCT01637961|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.|Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
28106|NCT01637935|Secondary|Stage of Bladder Cancer (10 Year Analysis)||January 1, 1997 to December 31, 2012|Participants diagnosed with bladder cancer.||percentage of participants|||Number
28107|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.||events per 100,000 person years||95% Confidence Interval|Number
28108|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.||events per 100,000 person years||95% Confidence Interval|Number
28111|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
28112|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
28113|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
28114|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
28115|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
28116|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
28117|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline|The SOWS is a subjective scale self-evaluated by the subject. The SOWS shows items reflecting the common motor, autonomic, gastrointestinal, musculo-skeletal, and psychic symptoms of opiate withdrawal. Subjects are instructed to rate each symptom on a scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely) at designated times [c.f. Section 3.1]. The minimum possible SOWS score is 0, the maximum 64. The following subjective criteria are answered by the subject using the scale below: 1) I feel anxious, 2) I feel like yawning 3) I am perspiring, 4) My eyes are watering, 5) My nose is running, 6) I have goose flesh, 7) I am shaking 8) I have hot flushes, 9) I have cold flushes, 10) My bones and muscles ache, 11) I feel restless, 12) I feel nauseous, 13) I feel like vomiting, 14) My muscles twitch, 15) I have cramps in my stomach, 16) I feel like shooting up now. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.||units on a scale||Full Range|Median
28118|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
28130|NCT01637246|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
28437|NCT01632423|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
28119|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg/ml]||Geometric Coefficient of Variation|Geometric Mean
28120|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
28121|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline|The OOWS is conducted by a trained independent examiner for either the presence or absence of the following symptoms during a 10 minute observation period at designated times during the trial. The minimum possible OOWS score is 0 and the maximum possible score is 13. Objective criteria: Yawning, Rhinorrhoea, Piloerection, perspiration, lacrimation, mydriasis, hot and cold flushes, restlessness, vomiting, tremors, anxiety, muscle twitches, abdominal cramps. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.||units on a scale||Full Range|Median
28122|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
28123|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
28124|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng*h/ml]||Geometric Coefficient of Variation|Geometric Mean
28125|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
28126|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng/ml]||Geometric Coefficient of Variation|Geometric Mean
28127|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
28128|NCT01637246|Secondary|Percentage of Patients Continuing on Therapy After 12 Weeks|Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
28131|NCT01637246|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Percentage of Patients|||Number
28132|NCT01637246|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 12 Weeks|All patients who met the study entry criteria and have data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
28133|NCT01637090|Secondary|Effect of mTOR on Tumors|Determine mTOR (mammilian target of rapamycin) pathway activation and number of regulatory T cells (Tregs) in pre-treated tumor tissue and evaluate changes following treatment|one year|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
28134|NCT01637090|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Determine the adverse event profile and tolerability of everolimus in patients with CTCL|Up to one year|||participants|||Number
28135|NCT01637090|Secondary|Progression-free Survival|Determine progression-free survival of CTCL patients treated with everolimus|two years after discontinuing study treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
28136|NCT01637090|Secondary|Time to Response|Determine time to response (TTR)/duration of objective response (DOR)|three months|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
28137|NCT01637090|Primary|Efficacy of Treatment|Determine the efficacy of everolimus in the treatment of CTCL as overall response rate (ORR)|12 months after beginning treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure|||||
28138|NCT01636986|Primary|Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ|Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.|Day 0, Week 4|All enrolled and randomized participants who completed the study.||Units on a scale||Standard Deviation|Mean
28139|NCT01636960|Secondary|Number of Participants Discontinuing Study Drug Because of AEs|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 1 year (to be updated as data collection continues)|All participants receiving at least one dose of study drug.||Participants|||Number
28140|NCT01636960|Secondary|Safety: Number of Participants Experiencing Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 1 year (to be updated as data collection continues)|All participants who received at least one dose of study drug.||Participants|||Number
28141|NCT01636960|Primary|Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase|A DLT is an event (clinical or laboratory) that results in a change in the given dose.|Up to 8 weeks|All participants in the induction phase of the study||Participants|||Number
28142|NCT01636947|Secondary|Percentage of Participants With No Vomiting - Acute and Delayed Stages|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1, Day 2 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
28143|NCT01636947|Secondary|Percentage of Participants With One or More Clinical Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event.|Day 1 through Day 29 (Up to 28 days after first dose of study drug)|All randomized participants who received chemotherapy and took ≥1 dose of study drug.||Percentage of Participants|||Number
28144|NCT01636947|Secondary|Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages|The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
28145|NCT01636947|Secondary|Percentage of Participants With No Impact on Daily Life - Overall Stage|"The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, No Impact on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC."|Day 6|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug, had ≥1 post-treatment assessment on Day 1 and Day 2 and completed the FLIE questionnaire on Day 6.||Percentage of Participants|||Number
28146|NCT01636947|Secondary|Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage|"Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: How much nausea have you had over the last 24 hours? The left end of the scale (0 mm) was labeled no nausea, and the right end of the scale (100 mm) is labeled nausea as bad as it could be. In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm."|Days 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
28147|NCT01636947|Secondary|Number of Emetic Events - Overall Stage|The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Number of Emetic Events|||Number
28148|NCT01636947|Secondary|Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages|A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
28149|NCT01636947|Primary|The Percentage of Participants With No Vomiting - Overall Stage|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The modified intention-to-treat (mITT) population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.||Percentage of Participants|||Number
28150|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|FU Week 24|SP2 Population.||Cm||Standard Deviation|Mean
28151|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).||Centimeters (cm)||Standard Deviation|Mean
28152|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|FU Week 24|SP2 Population.||Participants|||Number
28153|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).||Participants|||Number
28154|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|FU Baseline and FU Week 24|SP2 Population.||Participants|||Number
28155|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal|SP1 Population.||Participants|||Number
28156|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|FU Baseline and FU Week 24|SP2 Population.||Participants|||Number
28157|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal|SP2 Population.||Participants|||Number
28170|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||Degrees centigrade||Standard Deviation|Mean
28158|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24|SP1 Population.||Participants|||Number
28159|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population,||Participants|||Number
28160|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.||Participants|||Number
28161|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.||Participants|||Number
28162|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population.||Participants|||Number
28163|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.||Participants|||Number
28164|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.||Participants|||Number
28165|NCT01636778|Secondary|Mean BMI at the Indicated Time Points During Follow-up Period After Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
28166|NCT01636778|Secondary|Mean Change From Baseline in BMI at the Indicated Time Points in Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||kg/m^2||Standard Deviation|Mean
28167|NCT01636778|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
28168|NCT01636778|Secondary|Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2|The Body temperature of participants was recorded at the indicated time points..|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population||Degrees centigrade||Standard Deviation|Mean
28169|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||Degrees centigrade||Standard Deviation|Mean
28438|NCT01632267|Secondary|Number of Disability Claims|Number of disabiity claims during study window|During the one year study window (April 1, 2010 to April 1, 2011)||||||
28172|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 2|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||kg||Standard Deviation|Mean
28173|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||Kilogram (kg)||Standard Deviation|Mean
28174|NCT01636778|Secondary|Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2|The heart rate was measured in participants at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.||bpm||Standard Deviation|Mean
28175|NCT01636778|Secondary|Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2|The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline.|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.||bpm||Standard Deviation|Mean
28176|NCT01636778|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period|The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.||Beats per minute (bpm)||Standard Deviation|Mean
28177|NCT01636778|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.||mmHg||Standard Deviation|Mean
28178|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.||mmHg||Standard Deviation|Mean
28179|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24|SP1||Millimeter of mercury (mmHg)||Standard Deviation|Mean
28180|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From FU Baseline up to FU Week 24 after Part 2|SP2 Population||Participants|||Number
28181|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Antiviral Baseline up to Week 48 in Part 2|Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.||Participants|||Number
28182|NCT01636778|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Baseline up to week 9 in Part 1|Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag.||Participants|||Number
28183|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2|FU Baseline, FU Week 12 and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis.||Log international unit per milliliter||Standard Deviation|Mean
28184|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points In Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal.|Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2|FAS2 Population.||Log international unit per milliliter||Standard Deviation|Mean
28185|NCT01636778|Secondary|Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2|ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28186|NCT01636778|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28187|NCT01636778|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28188|NCT01636778|Secondary|Number of Participants With Sustained Virologic Response (SVR) in Part 2|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28189|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.||Participants|||Number
28190|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.||Participants|||Number
28191|NCT01636778|Secondary|Number of Participants Achieving Adherence to Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28192|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.||Participants|||Number
28193|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.||Participants|||Number
28194|NCT01636778|Secondary|Number of Participants Who Discontinued Antiviral Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28195|NCT01636778|Secondary|Time to First Dose Reduction of Antiviral Therapy in Part 2|Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||weeks||Standard Deviation|Mean
28196|NCT01636778|Secondary|Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28197|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed.||Participants|||Number
28198|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed.||Participants|||Number
28439|NCT01632267|Secondary|Number of Medical Absence Days|Number of medical absence days during study window|During the one year study window (April 1, 2010 to April 1, 2011)||||||
28199|NCT01636778|Secondary|Number of Antiviral Therapy Dose Reductions in Part 2|Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.||Participants|||Number
28200|NCT01636778|Secondary|Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy|Participants received eltrombopag at escalating dosages until a platelet count of >=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.||Participants|||Number
28201|NCT01636778|Secondary|Minimum Platelet Count on Antiviral Therapy|"Participants were assessed for platelet counts during antiviral therapy in Part 2.~Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|FAS2 Population: all participants enrolled in Part 2.||Participants|||Number
28202|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2|Platelet counts were measured by blood draw at specified timepoints.|Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis.||Gi/L||Full Range|Median
28203|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 2|Platelet counts were measured by blood draw|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|FAS2 Population.||Gi/L||Full Range|Median
28204|NCT01636778|Secondary|Time in Weeks to Achieve Platelet Count >= 100 Gi/L|Participants were assessed for achieving platelet counts >=100 Gi/L during Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.||Participants|||Number
28205|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 1|Platelet counts were measured by blood draw|Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1|FAS1 Population.||10^9 Cells Per Liter (Gi/L)||Full Range|Median
28206|NCT01636778|Primary|Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2|"Participants were assessed for continuously maintaining platelet counts >=50 Gi/L during Part 2.~Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2.||Participants|||Number
28207|NCT01636778|Primary|Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1|Participants were assessed for a shift from a baseline platelet count of <80 Gi/L to a count >=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1.||Participants|||Number
28208|NCT01636765|Primary|Intra-rater Reliability of the CEA Scale|Intra-rater (within raters) agreement of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 104 participant's severity of erythema of rosacea using the CEA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.||Kappa statistics||95% Confidence Interval|Mean
28209|NCT01636765|Primary|Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale|Inter-rater agreement (among raters) of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters scored 104 participant's severity of erythema due to rosacea using the CEA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kendall’s W was provided.|Day 1|All enrolled participants.||Kendall's W||95% Confidence Interval|Mean
28210|NCT01636713|Secondary|Change From Baseline Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 1|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated using the 0-6-hour post-dose FEV1 measurements collected on Day 1, which included pre-dose (30 minutes [min] and 5 min prior to dosing) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at Day 1was calculated as the WM at post -dose value on Day 1 minus Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1). Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 and 5 minutes pre-dose on Day 1), smoking status, and country/region.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
28241|NCT01636076|Secondary|Duration (in Days) of COPD Exacerbations|Duration and number of the COPD exacerbation will be analyzed by the negative binomial regression model including treatment, country, smoking status, and COPD severity as factors and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||Days||Standard Deviation|Mean
28211|NCT01636713|Secondary|Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score, smoking status, country/region, day, day by Baseline dyspnea index (BDI) focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
28212|NCT01636713|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, country/region, day, day by Baseline and day by treatment interactions. par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
28213|NCT01636661|Secondary|Hand Function Decline as Measured by Number of Participants|Measured by the Box and Blocks Test and Grip Strength|Baseline, Posttest, Follow-Up Session at One-Week|||participants|||Number
28214|NCT01636661|Primary|Adverse Events/Safety Assessment.|"Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:~Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.~Physician Evaluation- Child identified as declining in function from pretest to posttest.~Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.~Detailed adverse events are reported in the adverse events module."|Baseline, Posttest, Follow-Up Session at One-Week|Pilot study therefore no sample size analysis. Completed per protocol.||Participants|||Number
28215|NCT01636466|Secondary|Incidence of Return to Dialysis Dependence||36 months||||||
28216|NCT01636466|Primary|Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)|Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI >5000 defined as positive|36 months|Single subject enrolled was terminated early. No data analysis occurred.|||||
28217|NCT01636414|Primary|Change in Hemoglobin Level|Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.|Post-operative on day 2 (first day after surgery)|||g/dl||Inter-Quartile Range|Median
28218|NCT01636414|Primary|Blood Transfusion|Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups|Inpatient Postoperative, on average 3 days after surgery|||participants|||Number
28219|NCT01636362|Secondary|Percent of Study Burn Healed.|Percent of study burn healed measured by PictZar photo analysis of tissue types.|At day 21|||percentage of healing||Full Range|Median
28220|NCT01636362|Primary|Proportion of Subjects Healed at Day 21.|The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.|Healing will be assessed after 21 days.|||participants|||Number
28221|NCT01636362|Primary|Number of Subjects Healed at Day 14.|> = 95 % epitheliazation|Healing will be assessed after 14 days.|||participants|||Number
28222|NCT01636258|Secondary|Sleep|Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).|baseline and followup visit (at 8-14 weeks)|||hours/night||Inter-Quartile Range|Mean
28223|NCT01636258|Secondary|Stress|Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.|baseline and followup visit (at 8-14 weeks)|||scores on a scale||Inter-Quartile Range|Mean
28224|NCT01636258|Secondary|Exercise|Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).|Baseline and final followup visits (at 8-14 weeks)|||steps/day||Inter-Quartile Range|Mean
28225|NCT01636258|Secondary|Diet - Daily Calorie Intake|Change in daily caloric intake as measured by online 24-hour recall dietary program|Baseline and final followup visit (at 8-14 weeks)|||Kcal/day||Inter-Quartile Range|Mean
28226|NCT01636258|Primary|"Effect of FRESH Program on Weight Loss"|Change in weight measured at baseline and followup (at 8-14 weeks).|Baseline line and final followup visit (at 8-14 weeks)|||kg||Standard Deviation|Mean
28227|NCT01636206|Primary|Evaluate Safety of Lifitegrast Compared With Placebo in the Treatment of Dry Eye Disease (DED) as Assessed by Ocular and Non-ocular TEAEs for 1 Year||Day 0 to Day 360|Safety population included all randomized participants who received at least 1 dose of investigational product.||participants|||Number
28228|NCT01636102|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
28307|NCT01634256|Secondary|Changes in AST(Aspartate Transaminase)|AST was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
28229|NCT01636102|Primary|Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.||Percentages of subjects||95% Confidence Interval|Number
28230|NCT01636102|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.||Ratio||95% Confidence Interval|Number
28231|NCT01636102|Primary|Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
28232|NCT01636076|Secondary|Pharmacokinetic Parameter--AUC0-t|Area under the plasma concentration time curve from time zero to time “t” post-dose is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||hr*pg/mL||Standard Deviation|Mean
28233|NCT01636076|Secondary|Pharmacokinetic Parameter--Tmax|Time to reach the maximum plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||Hr||Full Range|Median
28234|NCT01636076|Secondary|Pharmacokinetic Parameter: Cmax|Maximum observed plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||pg/mL||Standard Deviation|Mean
28235|NCT01636076|Secondary|Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint|Plasma indacaterol and mometasone furoate is to be measured in a subset of approximately 60 patients via central laboratory. Blood samples are collected at pre-dose on Day 1, 29, and 84; and post dose up to 4 hour on Day 1, up to 12 hours on Day 28 and 84. For sparse pharmacokinetic testing, blood samples will be collected at 23h 35 min post-dose following morning dose administration on Day 28 and 84, in all patients participating in this study.|Day 1, 29, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||pg/mL||Standard Deviation|Mean
28236|NCT01636076|Secondary|Plasma Cortisol Concentrations at Each Timepoint|Plasma cortisol to be measured in a subset of approximately 60 patients via central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1, up to 12 hours post-dose on Day 28 and Day 84, and 23 hour 35 minute on Day 2, Day 29, and Day 85, and at pre-dose 25 minute on Day 28, and Day 84.|Day 1, Day 28, Day 84|Safety set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.||nmol/mL||Standard Deviation|Mean
28237|NCT01636076|Secondary|Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period|Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.|12 weeks|Full analysis set consisting of all randomized patients||(Prednisolone dose equivalents) mg||Standard Deviation|Mean
28238|NCT01636076|Secondary|The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||Percentage participants|||Number
28239|NCT01636076|Secondary|Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||Days||Inter-Quartile Range|Median
28240|NCT01636076|Secondary|Percentage of Patients With at Least One Exacerbation up to Week 12|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that had an exacerbation up to week 12. Less exacerbations reflect a better outcome.|12 weeks|Full analysis set consisting of all randomized patients||Percentage of participants|||Number
28308|NCT01634256|Primary|Changes in ALT(Alanine Transaminase)|ALT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
28242|NCT01636076|Secondary|Annual Rate of COPD Exacerbations|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients||COPD Exacerbations per year||95% Confidence Interval|Number
28243|NCT01636076|Secondary|Time to First COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that were event free of a specified event.|12 weeks|Full analysis set consisting of all randomized patients||Percentage of participants event free||95% Confidence Interval|Number
28244|NCT01636076|Secondary|Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)|The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.|12 weeks|Full analysis set consisting of all randomized patients||COPD exacerbation per participant||Standard Deviation|Mean
28245|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale|The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.|Baseline, 4 and 12 weeks|Full analysis set.Higher scores show better outcomes.Excepting the sleep quantity subscale,scoring the MOS requires two steps:(a) assigning a point value to each response and (b) summing the point values for all the items in a given subscale or index. Each subscale and index score is then converted to a T score with a mean of 50 and an SD of 10.||hours of sleep||Standard Deviation|Mean
28246|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale|"Scoring the MOS Sleep Survey is a two-step process:• All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. For example, a score of 50 represents 50% of the highest possible score.~• Second, items within each scale are averaged together to create the 7 scale scores. Scales with at least one item answered can be used to generate a scale score. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scores represent the average for all items in the scale that the respondent answered. An additional measure is based on the average number of hours sleep each night during the past 4 weeks and are described in outcome measure 15."|Baseline, 4 and 12 weeks|Full analysis set.||Units on a scale||Standard Deviation|Mean
28247|NCT01636076|Secondary|Patient Reported Outcome Measures: COPD Assessment Test|It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.|Baseline, 4 and 12 weeks|Full analysis set consisting of all randomized patients||Units on a scale||Standard Deviation|Mean
28248|NCT01636076|Secondary|Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit|A TDI focal score of ≥1 is considered to be a clinically important improvement from baseline. Analysis of the proportion of subjects with a clinically important improvement of >=1 point in the TDI focal score, by visit|4 and 12 weeks|Full analysis set, All randomized patients. When data were missing or insufficient for any one of the domains a focal score could not be calculated.||(%) showing clinical improvement|||Number
28249|NCT01636076|Secondary|Patient Reported Outcome Measures: SGRQ (St. George’s Respiratory Questionnaire)|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|4 and 12 weeks|Full analysis set : At baseline all subjects with a baseline value are included. At each post-baseline day, only subjects with a value at both baseline and the respective day are included. Baseline SGRQ was completed on Day 1 prior to first dose.||Total Score||Standard Deviation|Mean
28250|NCT01636076|Secondary|The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .|This value represents the percent of days in the study where no rescue medication was needed.|Baseline to 12 weeks|Full analysis set consisting of all randomized patients||% of days||Standard Error|Least Squares Mean
28251|NCT01636076|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist)|Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.|12 weeks|Full analysis set consisting of all randomized patients||Number of puffs||Standard Error|Least Squares Mean
28252|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min – 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 28, Day 84|Peak FEV1 was calculated for all subjects in the FAS at Day 1 (Visit 201) and was calculated for all subjects in the 24-h profiling subset of the FAS at Day 1 (Visit 201), Day 28 (Visit 203) and Day 84 (Visit 205).||Liters*hours||Standard Error|Least Squares Mean
28253|NCT01636076|Secondary|FEV1 AUC (5 Min-4 h),|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 1(Baseline), Day 28, Day 84|24 hr profiling subgroup||Liters*hours||Standard Error|Least Squares Mean
28254|NCT01636076|Secondary|FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min – 4h)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), Scheduled (not actual) time points are to be used. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment.|Day 1|Full analysis set consisting of all randomized patients||Liters * hours||Standard Error|Least Squares Mean
28255|NCT01636076|Secondary|FEV1/FVC at Each Timepoint|Spirometry is conducted according to the global standard. FEV1/FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients||FEV1/ FVC (%)||Standard Deviation|Mean
28256|NCT01636076|Secondary|Forced Vital Capacity (FVC) at Each Timepoint|Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients||liters||Standard Deviation|Mean
28257|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint||Day 1 through day 85|Full analysis set consisting of all randomized patients||liter||Standard Error|Least Squares Mean
28258|NCT01636076|Secondary|Trough FEV1 After First Dose and After 4 Weeks of Treatment|Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 1 hours on Day 1 and Day 28; 24 hours post-dose on Day 29 and 85. In a subset of approximately 60 patients, FEV1 is measured up to 20 hours postdose on Day 28 and Day 84.|Day 1 and Day 85|All randomized patients were included in the Safety analysis set (SAF) and Full analysis set (FAS).||Liters||Standard Error|Mean
28259|NCT01636076|Primary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85|Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.|12 weeks|All randomized patients were included in the Full analysis set (FAS)||Liters||Standard Error|Least Squares Mean
28260|NCT01635933|Secondary|Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)|Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where ‘study lenses’ refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.|Day 28|The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values.||Percentage of participants|||Number
28261|NCT01635933|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.||Units on a scale||Standard Deviation|Mean
28262|NCT01635933|Primary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.||Units on a scale||Standard Deviation|Mean
28263|NCT01635920|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
28264|NCT01635920|Primary|Percentage of Subjects With Same Fit in Both Eyes|"Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. Same fit was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit."|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.||percentage of participants|||Number
28265|NCT01635881|Secondary|In-hospital Major Adverse Cardiac Events (MACE)|"In-hospital MACE:~All death (cardiac and non-cardiac)~Myocardial infarction (MI)~Target Vessel Revascularization (TVR)~In-hospital Stent Thrombosis (ST) within the target vessel~Clinically significant arrhythmias (requiring intervention)"|Participants will be followed for the duration of hospital stay (an expected average of 24 hours)|Analysis population consists of intent-to-treat subject population.||percentage of participants||95% Confidence Interval|Number
28266|NCT01635881|Primary|Device Procedural Success|"Device procedural success consisting of the following:~Successful delivery, inflation, deflation and withdrawal of the study balloon.~No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon.~Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure"|Peri-procedural|Analysis population consists of intent-to-treat subject population.||percentage of participants||95% Confidence Interval|Number
28267|NCT01635855|Primary|Rate of Severe Common Adverse Events|The purpose of this study was to determine if the rate of “Severe” common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies).“Common” is defined as pre-specified adverse events occurring in >= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.|1 month|||percentage of 'severe' common AEs||95% Confidence Interval|Number
28268|NCT01635504|Primary|Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks|||percentage reduction in parotid volume||Full Range|Mean
28269|NCT01635504|Primary|Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks|||percentage reduction in masseter volume||Full Range|Mean
28270|NCT01635439|Secondary|Normal Vaginal Delivery Rate||24 hours|||participants|||Number
28271|NCT01635439|Secondary|Need for Syntocinon Augmentation||24 hours|||participants|||Number
28272|NCT01635439|Secondary|Uterine Hyper-stimulation Rate||24 hours|||participants|||Number
28273|NCT01635439|Secondary|Induction to Onset of Labor Interval||24 hours|||hours||Standard Deviation|Mean
28274|NCT01635439|Primary|Induction to Delivery Interval||24 hours|||hours||Standard Deviation|Mean
28275|NCT01635244|Primary|Aortic Valve Mean Gradient (mm Hg) at Peak Exercise|This is a measure of the resistance to flow across the aortic bioprosthesis.|6 months after aortic valve replacement|||mm Hg||Inter-Quartile Range|Median
28276|NCT01635218|Secondary|Remission Rates at 6 Weeks|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score < 7 points after 6 weeks of treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.||participants with a score of < 7 in HS|||Number
28277|NCT01635218|Secondary|Change From Baseline in Greene´s Scale at 6 Weeks.|Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and > 50 (severe symptoms).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.||Units in Green Scale||Standard Deviation|Mean
28278|NCT01635218|Secondary|Responder Rates at 6 Weeks.|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.||participants with a decrease >50% in HS|||Number
28279|NCT01635218|Secondary|Change From Baseline in Beck Depression Inventory at 6 Weeks.|Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), > 29 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.||Units in Beck Depression Inventory||Standard Deviation|Mean
28280|NCT01635218|Primary|Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.|17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented in outcome measure data table are the final scores in Hamilton Scale after 6 weeks of treatment.||Units in Hamilton Scale||Standard Deviation|Mean
28281|NCT01634659|Secondary|End of Day Comfort|End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
28282|NCT01634659|Secondary|Overall Quality of Vision|Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
28283|NCT01634659|Primary|Overall Comfort|Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
28284|NCT01634620|Primary|Mean FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population||parts per billion (ppb)||Standard Deviation|Mean
28285|NCT01634620|Primary|FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population||participants|||Number
28286|NCT01634620|Primary|FeNO Levels by Smoking Status|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit.|Single Visit|||participants|||Number
28287|NCT01634620|Primary|FeNO Levels by Inhaled Corticosteroid Use|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit.|Single Visit|Per-protocol Population||participants|||Number
28288|NCT01634620|Primary|FeNO Levels by GOLD Stage of Severity|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category.|Single Visit|Per-protocol Population||parts per billion (ppb)||Standard Deviation|Mean
28289|NCT01634620|Primary|Spirometry Results: PEF (L/Min)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters per minute||Standard Deviation|Mean
28290|NCT01634620|Primary|Spirometry Results: FEF25-75 (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters per second||Standard Deviation|Mean
28291|NCT01634620|Primary|Spirometry Results: FEF50% (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters per second||Standard Deviation|Mean
28292|NCT01634620|Primary|Spirometry Results: FEV1 (% Predicted)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Percent Predicted||Standard Deviation|Mean
28293|NCT01634620|Primary|Spirometry Results: FVC (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters||Standard Deviation|Mean
28294|NCT01634620|Primary|Spirometry Results: FEV1 (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population||Liters||Standard Deviation|Mean
28295|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 2.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
28296|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 1.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
28297|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 2.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
28298|NCT01634555|Secondary|Development of Antibodies Against Ramucirumab||Prior to ramucirumab infusion in Cycle 2, Day 1, End of treatment, and 30-day follow-up||06/2017||||
28299|NCT01634555|Secondary|Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)||Cycle 2: -2, -1, -0.5, 0, 2, 3, 4, 5, 8, 10, 25, 48, 72, 96, 168, 264, 336 hours post-ramucirumab (IMC-1121B) infusion|All participants who received study drug and had sufficient concentration data to calculate ramucirumab (IMC-1121B) Cmax in Cycle 2.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
28300|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 1.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
28301|NCT01634360|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|"Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56.~ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor."|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population||Scores on scale||Standard Deviation|Mean
28302|NCT01634360|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population||Hours||Standard Deviation|Mean
28303|NCT01634360|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made.||Hours||Standard Deviation|Mean
28304|NCT01634256|Secondary|Changes in Serum Bilirubin|serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
28305|NCT01634256|Secondary|Changes in γ-GT(Gamma-Glutamyl Transferase)|γ-GT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
28306|NCT01634256|Secondary|Changes in ALP(Alkaline Phosphatase)|ALP was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||IU/L||Standard Deviation|Mean
28310|NCT01634243|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
28311|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
28312|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
28313|NCT01634243|Secondary|UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
28314|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
28315|NCT01634243|Secondary|UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
28316|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, LOCF||Scores on a scale||Standard Deviation|Mean
28317|NCT01634243|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum at 12 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
28318|NCT01634243|Secondary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|Incidence and severity of adverse events, vital signs, and laboratory parameters following the initiation of study treatment.|Up to 12 weeks after dosing|Safety analysis set||participants|||Number
28319|NCT01634243|Primary|Maintenance Dose of the SPM962|The maintenance dose of the SPM 962 was examined based on the safety and efficacy.|Up to 12 weeks after dosing|Subjects in the safety analysis set who entered the maintenance period||participants|||Number
28320|NCT01634165|Secondary|Total Amount of Glucose Infused (Gtot)|Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Gtot measurements. Participants were analyzed based on the treatment they received.||milligrams per kilograms (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
28321|NCT01634165|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Rmax measurements. Participants were analyzed based on the treatment they received.||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
28322|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-tlast). Participants were analyzed based on the treatment they received.||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
28323|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
28324|NCT01634165|Primary|Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)||Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
28325|NCT01634165|Primary|Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]|Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
28326|NCT01634152|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at week 12.~A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary and no use of rescue medication reported via the eDiary during that day.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Days||Standard Error|Mean
28327|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at week 12.~Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28328|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at week 12.~Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28329|NCT01634152|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at week 12.~Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28330|NCT01634152|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at week 12.~Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28331|NCT01634152|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at week 12.~Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28332|NCT01634152|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at week 12.~Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28333|NCT01634152|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28334|NCT01634152|Secondary|FEV1 a.m. Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28335|NCT01634152|Secondary|Peak Expiratory Flow (PEF) Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Percentage of PEF||Standard Error|Mean
28440|NCT01632267|Primary|Number of Outpatient Visits|Number of outpatient healthcare visits during study window|During the one year study window (April 1, 2010 to April 1, 2011)|||units on a scale||Standard Deviation|Mean
28336|NCT01634152|Secondary|Peak Expiratory Flow (PEF) p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||L/min||Standard Error|Mean
28337|NCT01634152|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||L/min||Standard Error|Mean
28338|NCT01634152|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.~Measured values presented are actually adjusted means"|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
28339|NCT01634152|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
28340|NCT01634152|Secondary|Use of PRN Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at week 12.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
28341|NCT01634152|Secondary|ACQ-IA Total Score Responders|"Responder categories based on the ACQ-IA total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ-IA total score responders.~The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.||Percentage of participants|||Number
28342|NCT01634152|Secondary|Control of Asthma as Assessed by ACQ-IA Total Score|"Change from baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) total score measured at week 12.~The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28343|NCT01634152|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline at each individual timepoint.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28344|NCT01634152|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28345|NCT01634152|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28346|NCT01634152|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28347|NCT01634152|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28348|NCT01634152|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 12 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28441|NCT01632215|Primary|Pain Intensity|Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain|6 months|||units on a scale||Standard Deviation|Mean
28349|NCT01634152|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28350|NCT01634152|Primary|FEV1 Peak(0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28351|NCT01634139|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at weeks 24 and 48.~A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary (electronic diary) and no use of rescue medication reported via the eDiary during that day.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Days||Standard Error|Mean
28352|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at weeks 24 and 48.~Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28353|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at weeks 24 and 48.~Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28354|NCT01634139|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at weeks 24 and 48.~Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28355|NCT01634139|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at weeks 24 and 48.~Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28356|NCT01634139|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at weeks 24 and 48.~Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28357|NCT01634139|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at weeks 24 and 48.~Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a scale||Standard Error|Mean
28412|NCT01633320|Primary|Analgesia/Nociception Index (ANI)|The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.|At arrival in post-operative care unit (PACU) or 10 min after extubation|||units on a scale||Standard Deviation|Mean
28358|NCT01634139|Secondary|Responders in PAQLQ(S) at Weeks 24 and 48|"Responders in PAQLQ(S) at weeks 24 and 48. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≥0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≤-0.5). No statistical testing was performed for PAQLQ(S) total score responders.~The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control)."|Weeks 24 and 48.|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.||Patients|||Number
28359|NCT01634139|Secondary|PAQLQ(S) Emotional Function Domain Score|"PAQLQ(S) emotional function domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
28360|NCT01634139|Secondary|PAQLQ(S) Activity Limitation Domain Score|"PAQLQ(S) activity limitation domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
28361|NCT01634139|Secondary|PAQLQ(S) Symptom Domain Score|"PAQLQ(S) symptom domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score was calculated as the mean of the items in the domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
28362|NCT01634139|Secondary|PAQLQ(S) Total Score|"Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) total score at weeks 24 and 48.~The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). Total Score is calculated as mean of all 23 questions.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
28363|NCT01634139|Secondary|ACQ−IA Responder Analysis|"Responder categories based on the ACQ-IA total score after 24 and 48 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5). No statistical testing was performed for ACQ-IA total score responders.~The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Weeks 24 and 48|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason||Patients|||Number
28364|NCT01634139|Secondary|ACQ−IA Total Score|"Interviewer Administered Asthma Control Questionnaire (ACQ-IA) total score after 24 and 48 weeks of treatment.~The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Units on a Scale||Standard Error|Mean
28365|NCT01634139|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28366|NCT01634139|Secondary|FEV1 a.m Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 24 and 48.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
28367|NCT01634139|Secondary|PEF Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Percentage of PEF||Standard Error|Mean
28368|NCT01634139|Secondary|PEF p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres per min (L/min)||Standard Error|Mean
28369|NCT01634139|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres per min (L/min)||Standard Error|Mean
28370|NCT01634139|Secondary|Use of PRN Rescue Medication During Nighttime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during nighttime based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
28371|NCT01634139|Secondary|Use of PRN Rescue Medication During Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during daytime based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
28372|NCT01634139|Secondary|Use of PRN (Pro re Nata) Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at weeks 24 and 48.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
28373|NCT01634139|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline to week 24 at each individual timepoint.~The measured values presented are actually adjusted means~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at Week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28374|NCT01634139|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28375|NCT01634139|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28376|NCT01634139|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 24 and 48 Weeks of treatment.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28377|NCT01634139|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"FEV1 change from baseline to week 24 at each individual timepoint.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28413|NCT01632904|Secondary|Percentage of Subjects Achieving a Durable Response on Individual Symptoms Scores for TSS-C||Week 48||||||
28414|NCT01632904|Secondary|Percentage of Subjects Achieving a Durable Response on TSS-C|Durable Response on TSS-C defined as a ≥ 50% improvement from baseline in TSS-C at Week 16 that was maintained at the Week 48 visit.|Week 48||||||
28378|NCT01634139|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28379|NCT01634139|Secondary|FEV1 Peak (0-3h) at Week 48 Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and Week 48.|FAS. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28380|NCT01634139|Secondary|Trough FEV1 Change From Baseline|"Change from Baseline in Trough (pre-dose) Forced Expiratory Volume (FEV) in 1 second (FEV1) measured at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28381|NCT01634139|Primary|FEV1 Peak (0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 24.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 24 Weeks.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres (L)||Standard Error|Mean
28382|NCT01634113|Secondary|Individual FVC Measurements|Change from baseline in individual FVC measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28383|NCT01634113|Secondary|Individual FEV1 Measurements|Change from baseline in individual FEV1 measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28384|NCT01634113|Secondary|FVC AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28385|NCT01634113|Secondary|Trough FVC Change From Baseline|Change from baseline of trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 12 weeks of treatment.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28386|NCT01634113|Secondary|FVC Peak (0-3h) Change From Baseline|Change from baseline in maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak (0–3h)) after 12 weeks of treatment.|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28387|NCT01634113|Secondary|FEV1 AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28388|NCT01634113|Secondary|Trough FEV1 Change From Baseline|Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28389|NCT01634113|Secondary|Weekly Mean Nighttime Awakenings Due to Asthma Symptoms|"Change from baseline in the weekly mean nighttime awakenings due to asthma symptoms as assessed by the PACD, in the last week of the 12 week treatment period.~The weekly mean was calculated as the average of the weekly scores for the question “Did your child wake up during the night due to his/her asthma?” The question was answered on a 5-point verbal rating scale, with scores ranging from 1 (did not wake up) to 5 (was awake all night). A week was defined as 7 days.~The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||units on a scale||Standard Error|Mean
28435|NCT01632423|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28390|NCT01634113|Secondary|Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication|Weekly percentage of days with use of salbutamol (albuterol) rescue medication at week 12. A week was defined as 7 days.|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||percentage of days||Standard Deviation|Mean
28391|NCT01634113|Secondary|Weekly Percentage of Days Without Asthma Symptoms|"Weekly Percentage of days without asthma symptoms at week 12.~A day without asthma symptoms was defined as a day during which the patient experienced no asthma symptoms, did not use rescue medication (salbutamol/albuterol) and had no asthma exacerbation/worsening requiring systemic corticosteroids, or unscheduled visits to a doctor’s office, emergency department, or hospital. A week was defined as 7 days.~The measured values presented are adjusted means"|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||percentage of days||Standard Error|Mean
28392|NCT01634113|Secondary|Weekly Mean Overnight Asthma Symptom Score Response|"Change from baseline in the weekly mean overnight asthma symptom score response as assessed by the PACD in the last week of the 12 week treatment period.~The overnight score is the score from the following question in the PACD, How much did your child cough last night after your child was put to bed for the night until he/she awoke this morning?. This endpoint was determined only for patients with 2 or more nights with symptoms per week during the baseline period. In this case, the baseline period is the 7 days used to derive the baseline value. A patient has a night with symptoms if the question was answered with scores 1, 2, 3, 4 or 5 or the patient received β-Agonist at least one time since he/she went to bed. A week was defined as 7 days.~Scores range from 0 (best) to 4 (worst), a value of 5 indicates severity of symptoms is unknown.~The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||units on a scale||Standard Error|Mean
28393|NCT01634113|Primary|FEV1 Peak (0-3h) Change From Baseline|Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.||Litres||Standard Deviation|Mean
28394|NCT01634113|Primary|Weekly Mean Combined Daytime Asthma Symptom Score|"Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period.~The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days.~The combined daytime score is the average of scores from questions 4 – 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst).~The measured values presented are adjusted means."|Baseline and 12 weeks|Full analysis set, which included all randomised patients who received at least one dose of trial medication, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.||units on a scale||Standard Error|Mean
28395|NCT01634100|Secondary|Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
28396|NCT01634100|Primary|Total Empa: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total empa in plasma, per period.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
28397|NCT01634100|Primary|Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
28415|NCT01632904|Secondary|Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16|The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For individual symptom scores within the TSS-C cluster, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.||Percentage of participants|||Number
28436|NCT01632423|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28398|NCT01633944|Secondary|Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with MOS assessment at week 12 (n=199 buprenorphine and n=194 placebo).||units on a scale||Standard Deviation|Mean
28399|NCT01633944|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with RMDQ assessment at week 12 (n=193 buprenorphine and n=189 placebo).||units on a scale||Standard Deviation|Mean
28400|NCT01633944|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (41). Includes only participants with PGIC assessment at week 12 (n=198 buprenorphine and n=194 placebo).||units on a scale||Standard Deviation|Mean
28401|NCT01633944|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||percentage of participants|||Number
28402|NCT01633944|Secondary|Time to Optimal Dose of Open-label Study Medication|Overall time to reach the “optimal” dose of study medication required to progress to double-blind treatment.|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment.||days||Standard Deviation|Mean
28403|NCT01633944|Secondary|Number of Subjects With Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary.|Week 1 to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||participants|||Number
28404|NCT01633944|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||participants|||Number
28405|NCT01633944|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.||units on a scale||Standard Deviation|Mean
28406|NCT01633853|Primary|The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.|The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.|24 months|||pg/ml||Standard Deviation|Mean
28407|NCT01633853|Primary|The Blood Levels of Phosphorus at the 24th Month of Following up.|The blood levels of phosphorus at the 24th month of following up will be detected.|24 months|||mmol/L||Standard Deviation|Mean
28408|NCT01633853|Secondary|The Incidence Rate of Secondary Hyperparathyroidism.|Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups.|24 months|||participants|||Number
28409|NCT01633853|Secondary|The Blood 25(OH)Vitamin D Level.|The levels of blood 25(OH)Vitamin D at the 24th month of following up.|24 months|||ng/ml||Standard Deviation|Mean
28410|NCT01633853|Primary|The Blood Levels of Calcium at the 24th Month of Following up.|The blood levels of calcium at the 24th month of following up will be detected.|24 months|||mmol/L||Standard Deviation|Mean
28411|NCT01633320|Primary|Pain Scores on a 0-10 Numeric Rating Scale (NRS)|Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain|At arrival in PACU or 10 min after extubation|||units on a scale||Standard Deviation|Mean
28433|NCT01632423|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28442|NCT01632215|Secondary|Chronic Pain|Number of neuropathic pain and complex regional syndrome pain after 6 months|6 months||||||
28416|NCT01632904|Primary|Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary|Symptoms of polycythemia vera were assessed using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) electronic diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): tiredness, itching, muscle aches, night sweats, and sweats while awake. The total symptom score ranged from 0-50 and was calculated as the sum of the 5 symptom scores. A higher score indicates worse symptoms.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For the overall TSS-C score, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.||Percentage of participants|||Number
28417|NCT01632878|Primary|Number of Occurrences of Cardio-vascular Events|Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)|12 months|||events|||Number
28418|NCT01632800|Primary|Degree of Discomfort Under Applied Pulsed Magnetic Fields|Pulsed magnetic fields will be applied a total of forty-eight times to the right hand of each subject. After each time the magnet coil is pulsed, the subject will be asked if he or she notices any sensation (for example, tingling or tapping). Subjects will be asked to rate the sensation from 0 to 4, where 0 means no sensation, 1 means barely-noticeable sensation, 2 means easily noticeable sensation, 3 means unpleasant sensation, and 4 means very unpleasant sensation.|Bioeffects will be assessed within the five-minute application of each pulse sequence|||percentage of subjects with discomfort|||Number
28419|NCT01632735|Secondary|Social Support Utilization|"Self-help utilization was measured by the question: In the past 30 days, how many days did you attend self-help meetings like AA or NA to support your recovery?”"|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|Intent to treat model was used to assess the effects of the intervention (mobile continuing care) compared to aftercare as usual in terms of improvements in social support service utilization over time (baseline, discharge and follow-ups: 3-, 6- and 9-months post-discharge).||days per month||Standard Deviation|Mean
28420|NCT01632735|Secondary|Recovery Confidence (Self-efficacy) Over Time|"Change/improvements in mean recovery confidence score over time (measured by question How confident are you in your ability to be completely abstinent (clean) from alcohol and drugs in the next 30 days? (units on scale included 0=not at all, 1=slightly, 2=moderately, 3=considerably, 4-extremely)."|baseline, discharge, 3-, 6-, and 9-month follow-ups|Used an intent to treat design. Examined the effects of the intervention (mobile continuing care) compared to aftercare as usual on change in recovery self-confidence over time.||units on a scale||Standard Deviation|Mean
28421|NCT01632735|Secondary|Participation in Recovery Behaviors Over Time|Recovery behaviors defined as mean number of days doing extracurricular/recovery-goal directed activities using repeated measures over time.|baseline, discharge, 3-, 6- and 9-month follow-ups|Intent to treatment model was used. Mixed modeling used to examine differences in recovery behaviors (measured by mean days doing extracurricular/recovery-goal directed activities) over time between study conditions.||days per month||Standard Deviation|Mean
28422|NCT01632735|Primary|Primary Substance Use (Defined as Substance Received Treatment for)|Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|An intent to treat model was used. The primary outcome measure is primary substance use measured by urine drug test at baseline, discharge as well as at 3-, 6-, and 9-month follow-ups. Study retention at discharge was 95%, 92.5% at 3 months, 86.2% at 6 months, and 82.5% at 9 months.||percentage of positive urines|||Number
28423|NCT01632709|Secondary|Pain Visual Analogue Scale (VAS)|The Pain Visual Analogue Scale (VAS) is a scale from 0-100 where 0= no pain and 100=the worst pain|VAS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
28424|NCT01632709|Secondary|Change in Depression (CES-D 10)|The Center for Epidemiologic Studies Short Depression Scale (CES‐D 10) is a validated instrument that assesses depression. The CES-D 10 is a scale from 0-30 where 0= no depression and 30=the most depression|CES-D 10 collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
28425|NCT01632709|Secondary|Change in Perceived Anxiety (PASS)|The Pain Anxitey Symptoms Scale (PASS) is a validated instrument that assesses anxiety in.The PASS is a scale from 0-100 where 0= no anxiety and 100=the most anxiety|PASS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
28426|NCT01632709|Secondary|Change in Perceived Disability (PDI)|The PDI is a seven-item validated instrument that assesses perceived disability in 7 key life areas. The Pain Disability Scale is a scale from 0-70 where 0= no disability and 70=the most disability|PDI collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
28427|NCT01632709|Primary|Change in Pain|Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable)|Pain rating before and at 15 minutes and 1 hour post injection|all available data was analyzed (some subjects did not complete all outcomes)||units on a scale||Standard Deviation|Mean
28428|NCT01632683|Secondary|Complications|Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.|1 week||||||
28429|NCT01632683|Secondary|Use of Adjuncts|The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.|1 week||||||
28430|NCT01632683|Secondary|Laryngeal View|Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team.|1 week||||||
28431|NCT01632683|Secondary|Intubation Time|Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide|1 week||||||
28432|NCT01632683|Primary|Intubation Success Rate|Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide|1 week|||participants|||Number
28443|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.|Day 1 of treatment through 19 months|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.||Percentage of participants||95% Confidence Interval|Number
28444|NCT01632150|Primary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Day 1 of treatment through 19 months|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.||Percentage of participants||90% Confidence Interval|Number
28445|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.|Day 1 of treatment through 19 months|All participants who received thalidomide, elotuzumab, and dexamethasone (40), including those who had cyclophosphamide added to the regimen (11).||Percentage of participants||95% Confidence Interval|Number
28446|NCT01632150|Primary|Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Day 1 of treatment through 19 months|All participants who received thalidomide, elotuzumab, and dexamethasone (40) including those who had cyclophosphamide added to the regimen (11).||Percentage of participants||90% Confidence Interval|Number
28447|NCT01632020|Primary|Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.|||||
28448|NCT01632020|Primary|Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.|||||
28449|NCT01631929|Primary|Time to Achieve Patient Stabilization|"Time needed to achieve patient stabilization defined by:~Plasmatic glucose < 250 mg/dl~Blood pH > 7.3~Plasmatic bicarbonate > 15 mmol/L"|Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)|||Hours||95% Confidence Interval|Mean
28450|NCT01631864|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set (SAS): The SAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
28451|NCT01631864|Secondary|Oxidative Metabolism|Oxidative metabolism was assessed by indirect calorimetry.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.||carbon dioxide to oxygen ratio||95% Confidence Interval|Least Squares Mean
28452|NCT01631864|Secondary|Local Adipose Tissue Lipolysis, Glycerol Concentrations|Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.||micro mol/L||95% Confidence Interval|Geometric Mean
28453|NCT01631864|Primary|Change From Baseline in Insulin Sensitivity Index|The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.|baseline, 8 weeks|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.||ug/kg*min/(mmol/L*pmol/L)||95% Confidence Interval|Mean
28454|NCT01631825|Secondary|Each Item of UPDRS Part 4|The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
28455|NCT01631825|Secondary|Each Item of UPDRS Part 3 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of Participants|||Number
28456|NCT01631825|Secondary|Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state).~A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
36463|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM record||mmHg||Standard Deviation|Mean
28461|NCT01631825|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness. The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.~The data at week 52 is shown."|Baseline, up to 54 weeks after dosing.|FAS, LOCF||Percentage of participants|||Number
28462|NCT01631825|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score.~A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28463|NCT01631825|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score.~A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28464|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Off State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28465|NCT01631825|Secondary|UPDRS Part 2 Sum Score (On State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28466|NCT01631825|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28467|NCT01631825|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Baseline, up to 54 weeks after dosing|FAS subjects with measurable off time at baseline, LOCF||Hours||Standard Deviation|Mean
28468|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Average of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state).~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28469|NCT01631825|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state).~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
28470|NCT01631825|Primary|Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters.~AEs of special interest (1-3) are defined as below:~sudden onset of sleep~obsessive-compulsive disorder or impulse-control disorder~hallucination, delusion~Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed."|Up to 55 weeks after dosing|Safety set (SS)||participants|||Number
28471|NCT01631812|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.~-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS||participants|||Number
28472|NCT01631812|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Up to 54 weeks after dosing|FAS subjects with “off state” at baseline||Hours||Standard Deviation|Mean
28473|NCT01631812|Secondary|UPDRS Part 2 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 weeks after dosing UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|||Scores on a scale||Standard Deviation|Mean
28474|NCT01631812|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) up to 54 weeks after dosing UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
28475|NCT01631812|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.|"Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.~*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)||participants|||Number
28599|NCT01629134|Primary|Injector Rating of the Natural Look and Feel of the Lips|Percentage of injectors who rated the look and feel of subjects’ lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
28476|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28477|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28478|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28479|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28480|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28481|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28482|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28483|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28484|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28485|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28486|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28487|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28488|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28489|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28490|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28491|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28492|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28493|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28494|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28495|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28540|NCT01631071|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase from baseline||95% Confidence Interval|Number
28496|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28497|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28498|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28499|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28500|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28501|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28502|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28503|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28504|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28541|NCT01631071|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
28505|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
28506|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28507|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28508|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28509|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28510|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28511|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28512|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28513|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28514|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|6 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
28515|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
28591|NCT01629134|Secondary|Rating of Injection Discomfort|The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).|15 minutes after injection|All subjects who met the criteria and treatment was initiated||scale score||Standard Deviation|Mean
28516|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|4 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
28517|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|3 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
28518|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|2 hous after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
28519|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|1 hour after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
28520|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the subject receiving an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions||Units on a scale||Standard Error|Least Squares Mean
28521|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28522|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28523|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28524|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28525|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28526|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28600|NCT01629134|Primary|Subject Rating of the Natural Look and Feel of the Lips|Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
28527|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28528|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
28529|NCT01631435|Primary|Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon|"the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy.~The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy.~Each patient was classified as follows:~Active Crohn's disease is likely~Active Crohn's disease is NOT likely~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"|All the end points and outcomes measures will be evaluated within 4 months from end of enrollment|subjects with symptoms associated with Crohn's disease||number of subjects|||Number
28530|NCT01631227|Primary|Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline|Change from baseline of diastolic blood pressure (DBP), sitting|8 weeks|Full analysis subject sample||mmHg||Standard Deviation|Least Squares Mean
28531|NCT01631149|Secondary|Nausea and Vomiting|"Using a yes - no questionnaire, the patients will be asked whether they are nauseated or not or whether they vomited. In fact yes indicates the nr of participants.~No statistical analysis was performed."|Measurements will be made during the stay in the operating room for an average period of 3 hours|||participants|||Number
28532|NCT01631149|Secondary|Postoperative Sedation Score|"Using a 5-point sedation scale, sedation levels will be obtained throughout the postoperative period.~0 = wide awake 5= severely sedated, The sedation data were averaged over time."|Measurements will be made during the stay in the operating room for an average period of 3 hours|||units on a scale (0-5)||Standard Error|Mean
28533|NCT01631149|Secondary|Post-operative Pain|"Using a 10 cm visual analogue score pain relief score will be measured. 0 = no pain 10 = most severe pain~No statistical analysis was performed!"|measurements are made in the recovery room following surgery for an average prior of 1 hour|The pain data were averaged over time and compared by t-test between groups||units on a scale (0-10 cm)||Standard Deviation|Mean
28534|NCT01631149|Secondary|Breathing|"In the recovery room the respiratory rate will be measured continuously using the Respir8 respiratory rate monitor. The data will be recorded on the CRF at 15 min intervals.~Breathing rate units are number of breaths as measured in 1 min.~Comparison by t-test: NS between treatments"|Measurements will be made during the stay in the recovery room for an average period of 3 hours|In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test||breaths per min||Standard Deviation|Mean
28535|NCT01631149|Primary|Surgical Rating Scale|"During the procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale. In order to reduce variability in the surgical rating all surgeries will be performed by one single surgeon. The rating scale will be a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals. In case of a sudden change in surgical conditions additional scores will be added to the case record form. If conditions are poor (score 1 or 2), muscle relaxation will be increased, a score of 1 will be used.~In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test"|Measurements will be made during the stay in the operating room for an average period of 3 hours|Each participant that was dosed was analyzed||units on a scale (1-5)||Standard Deviation|Mean
28536|NCT01631110|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase from baseline||95% Confidence Interval|Number
28537|NCT01631110|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
28538|NCT01631110|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects||Participants|||Number
28539|NCT01631110|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
28542|NCT01631071|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|||participants|||Number
28543|NCT01631071|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of subjects||95% Confidence Interval|Number
28544|NCT01630694|Secondary|Mean Tongue Volume|The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart||cubic centimeters||Standard Deviation|Mean
28545|NCT01630694|Primary|Mean Hyomental Distance Ratio|A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart||ratio||Standard Deviation|Mean
28546|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant’s Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS||participants|||Number
28547|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS||participants|||Number
28548|NCT01630135|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 1, and Week 2/Early Withdrawal (EW)|FAS. Participants who were withdrawn before Visit 3 (Week 1) were not included in the analysis for Week 1.||participants|||Number
28549|NCT01630135|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28550|NCT01630135|Secondary|Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28551|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
28552|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
28553|NCT01630135|Secondary|Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28554|NCT01630135|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28555|NCT01630135|Secondary|Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28742|NCT01627002|Secondary|Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)||Up to 12 time-points up to 48 hours post dose|||ng/mL||Standard Deviation|Mean
28556|NCT01630135|Secondary|Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
28557|NCT01630135|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28558|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at the Indicated Days|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.|Baseline; Days 1 through 14|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28559|NCT01630135|Secondary|Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Percent change||Standard Error|Least Squares Mean
28560|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at Week 1 and Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.|Baseline; Week 1 and Week 2|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.||Scores on a scale||Standard Error|Least Squares Mean
28592|NCT01629134|Secondary|Comparative Rating With Previous Treatment|Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
28593|NCT01629134|Secondary|Return to Social Engagement|Time to return to normal daily activities|4 weeks|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
28561|NCT01630135|Primary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (2 weeks)|Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication||Scores on a scale||Standard Error|Least Squares Mean
28562|NCT01630109|Secondary|Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics|This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic.|12 hours|||Percentage of complete studies|||Number
28563|NCT01630109|Secondary|Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo.|12 hours|||minutes||Standard Deviation|Mean
28564|NCT01630109|Secondary|Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.|12 hours|||minutes||Standard Deviation|Mean
28565|NCT01630109|Primary|Difference in Treatment vs. Placebo in Pill Capsule Completion Rates|This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).|12 hours|||percentage of complete capsule studies|||Number
28566|NCT01629797|Secondary|Number of Correct Responses to Questionnaire Items Before and 2 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and two months after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and two months post-educational lecture.|before and 2 months after an educational lecture|||participants|||Number
28567|NCT01629797|Primary|Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture|In order to evaluate the immediate effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and post-educational lecture.|immediately before and after an educational lecture|||participants|||Number
28568|NCT01629784|Secondary|Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a questionnaire to assess knowledge about CLE and sun protection behaviors immediately before and three months after an educational lecture. The percentage of subjects who correctly answered a knowledge or behavioral assessment item were calculated pre- and three months post-educational lecture.|before and 3 months after an educational lecture|||percentage of participants|||Number
28569|NCT01629784|Primary|Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture|In order to evaluate the immediate effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a written questionnaire to assess knowledge about CLE and sun protection immediately before and after the educational lecture. The percentage of subjects who correctly answered a knowledge assessment item were calculated pre- and post-educational lecture.|immediately before and after an educational lecture|||percentage of participants|||Number
28570|NCT01629771|Primary|World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores|The WHODAS 2.0 is a generic health and disability assessment tool that describes effects of disease on six domains: Cognition, Mobility, Self-Care, Getting Along, Life Activities, and Participation in Society. Responses are measured on a 5-point scale from 1 (no difficulty) to 5 (extreme difficulty or cannot do). Scores are calculated using a WHO SPSS 36 version syntax for employed subjects and a WHO SPSS 32 version syntax for unemployed subjects. Scores for each domain range from 0 to 100, where 0 is associated with no impairment of health status, and 100 is associated with a greater impairment of health status.|Assessed after enrollment|||units on a scale||Inter-Quartile Range|Median
28571|NCT01629771|Primary|Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores|The LFSQQ was developed to assess quality of life in subjects with lymphatic filariasis through seven domains: Mobility, Self-Care, Usual Activities, Disease Burden, Pain/Discomfort, Psychological Health, and Social Participation. Items are scored on a 5-point scale (no problem, mild, moderate, severe, most severe), and scores for each domain are calculated based on the number of questions answered and the raw scores. Scores for each domain range from 0 to 100, where 0 is associated with a worse quality of life and 100 is associated with a better quality of life.|Assessed after enrollment|||units on a scale||Inter-Quartile Range|Median
28572|NCT01629771|Primary|Dermatology Life Quality Index (DLQI) Domain Scores|The DLQI is a 10-item questionnaire measuring skin-specific quality of life through six domains: Symptoms & Feelings, Daily Activities, Leisure, Work & School, Personal Relationships, and Treatment. Symptoms & Feelings, Daily Activities, Leisure, and Personal Relationships are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 3 is associated with a large effect on a patient's life. Work & School and Treatment are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 6 is associated with a large effect on a patient's life.|Assessed after enrollment|||units on a scale||Inter-Quartile Range|Median
36464|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM records||mmHg||Standard Deviation|Mean
28573|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated. A higher number indicates a higher percentage of non-viable cells relative to the total cell count.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
28574|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
28575|NCT01629706|Primary|Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of cells (viable and non-viable) was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
28576|NCT01629706|Primary|Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and transferred into well plates, each containing a soaking solution. Following a soaking duration of approximately 30 minutes, lenses were rinsed and transferred in individual glass vials. The cell content from the lens wash was taken to a laboratory and incubated with live/dead stains. The total number of cells (viable and non-viable) were counted using a microscope. Cells collected from right and left lens were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
28577|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable cells was counted using a microscope. Cells collected from right and left eyes were pooled.Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
28578|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of viable cells was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.||cells||Standard Deviation|Mean
28579|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1|"The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from each lens and each eye were counted separately using a microscope. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated.~A higher number indicates a higher percentage of non-viable cells relative to the total cell count."|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
28580|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from each lens and each eye were counted separately using a microscope. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||percentage of cells||Standard Deviation|Mean
28594|NCT01629134|Secondary|Need for Massage|Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
28595|NCT01629134|Secondary|Malleability of Product|Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)|15 minutes after injection|All subjects who met the criteria and treatment was initiated||Percentage of subjects|||Number
36465|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 6 month|||mmHg||Standard Error|Mean
28581|NCT01629706|Primary|Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory. The total number of fluorescein-stained cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in fluorescein-stained cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||cells||Standard Deviation|Mean
28582|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable (dead) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in non-viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||cells||Standard Deviation|Mean
28583|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial (corneal) cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/ dead stains. The number of viable (alive) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.||cells||Standard Deviation|Mean
28584|NCT01629693|Primary|"Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30"|Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.|Baseline, Day 30|This analysis population includes all participants who completed the protocol and had no major protocol violations.||units on a scale||Standard Deviation|Mean
28585|NCT01629589|Secondary|Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.|Up to 15 minutes post-vaccination|Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set.||Participants|||Number
28586|NCT01629589|Secondary|Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM.~Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer <LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set.||Participants|||Number
28587|NCT01629589|Secondary|Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) to Day 28 post-vaccination|Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
28588|NCT01629589|Secondary|Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus.~Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.||Participants|||Number
28589|NCT01629589|Secondary|Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test|Day 0 (pre-vaccination) to Day 28 post-vaccination|The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
28590|NCT01629589|Primary|Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.||Participants|||Number
36466|NCT01499810|Secondary|Change in Office Systolic BP||from baseline to 6 month|||mmHg||Standard Deviation|Mean
28601|NCT01628965|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.~-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS||participants|||Number
28602|NCT01628965|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score|Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
28603|NCT01628965|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|"Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing.~*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)||participants|||Number
28604|NCT01628926|Secondary|Dystonia (in the Daytime)|Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).|Baseline, 16 weeks after dosing|Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.||Percentage of Participants|||Number
28605|NCT01628926|Secondary|Dystonia (at an Early Hour)|Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.||Percentage of participants|||Number
28606|NCT01628926|Secondary|Clinical Global Impression (CGI)|"Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF||Percentage of Participants|||Number
28607|NCT01628926|Secondary|Effective Rate in Off Time|"Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing.~On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF||Percentage of participants||95% Confidence Interval|Number
28608|NCT01628926|Secondary|Effective Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
28609|NCT01628926|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
28610|NCT01628926|Secondary|On Time With Dyskinesia Disturbing Daily Activities|Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period.||Hours||Standard Deviation|Mean
28611|NCT01628926|Secondary|On Time Without Dyskinesia Disturbing Daily Activities|"Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing.~On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance.||Hours/day||Standard Deviation|Mean
28612|NCT01628926|Secondary|On Time|Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS, LOCF||Hours/day||Standard Deviation|Mean
28613|NCT01628926|Secondary|Parkinson's Disease Sleep Scale-2 (PDSS-2)|Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.|Baseline, 16 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28614|NCT01628926|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF||Hours/day||Standard Deviation|Mean
28615|NCT01628926|Secondary|UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.~UPDRS 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28616|NCT01628926|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing.~UPDRS Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 8 and 10 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28617|NCT01628926|Primary|Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 16 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
28618|NCT01628913|Secondary|Time to Treatment Failure (TTF)|Time from randomization to the date of the first of the following events:death due to any cause or progressive disease, treatment discontinuation due to toxicity or treatment discontinuation due to patient preference|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.|||||
28619|NCT01628913|Secondary|Overall Survival (OS)|Time from randomization to the date of death due to any cause|up to approx. 30 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.|||||
28620|NCT01628913|Secondary|Objective Response Rate|Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for all target and non-target lesions, as well as new lesions as assessed by CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of all target lesions; Overall Response (OR) = CR + PR.|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.|||||
28621|NCT01628913|Primary|Progression Free Survival (PFS)|PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.|up to approx. 18 months|Full analysis set: The Full analysis set (FAS) comprised all patients who were randomized to study treatment. According to the intent to treat principle, patient was analyzed according to the treatment and strata they had been assigned to during the randomization procedure.||Months||95% Confidence Interval|Median
28622|NCT01628848|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Mean change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness at 12 weeks after dosing.~The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided."|Baseline, 12 weeks after dosing|FAS, LOCF||Percentage of participants|||Number
28623|NCT01628848|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average score of on state and off state), UPDRS Part 3 sum score, and UPDRS Part 4 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28624|NCT01628848|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average score of on state and off state), and UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28625|NCT01628848|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28626|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28627|NCT01628848|Secondary|UPDRS Part 2 Sum Score (on State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28628|NCT01628848|Secondary|Effective Rate in Off Time|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing.|FAS subjects with measurable off time data at baseline, LOCF||Percentage of participants||95% Confidence Interval|Number
28743|NCT01627002|Primary|Immunogenicity|Anti-drug antibody data|Up to 28 days post dose|Safety analyses were performed on all subjects who received a dose of PA401 or placebo and who had any post-dose assessments||participants|||Number
28629|NCT01628848|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28630|NCT01628848|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing.|Baseline, 12 weeks after dosing|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
28631|NCT01628848|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|baseline, 12 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF||Hours||Standard Deviation|Mean
28632|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 12 weeks after dosing.~Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
28633|NCT01628848|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
28634|NCT01628692|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)|All treated participants.||Participants|||Number
28635|NCT01628692|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories|Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Baseline, post-treatment Week 12 (Follow-up period)|All treated participants. Here ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
28636|NCT01628692|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR were defined as hepatitis C virus (HCV) RNA levels <lower limit of quantitation, target not detected at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|End of treatment (Week 24)|All treated participants.||Percentage of participants||80% Confidence Interval|Number
28637|NCT01628692|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR were defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at both Week 4 and Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4 and Week 12|All treated participants.||Percentage of participants||80% Confidence Interval|Number
28638|NCT01628692|Primary|Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)|SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Post Treatment Week 12 (Follow-up period)|All participants who were randomized and received at least 1 dose of active study therapy (daclatasvir, simeprevir, ribavirin).||Percentage of participants||80% Confidence Interval|Number
28639|NCT01628692|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants.||Percentage of participants||80% Confidence Interval|Number
28640|NCT01628692|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants.||Percentage of participants||80% Confidence Interval|Number
28641|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥20% From Baseline|Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria||Percentage of Patients|||Number
28642|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥10% From Baseline|Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria||Percentage of Patients|||Number
28744|NCT01627002|Primary|Treatment Emergent Adverse Events||up to 14 days post dose|Safety analyses were performed on all subjects who receive a dose of PA401 or placebo and who had any post-dose measurements||Participants|||Number
28643|NCT01628614|Primary|Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline|Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria||Millimeters of Mercury (mmHg)|||Number
28644|NCT01628601|Secondary|Patients Continuing With GANfort® After 18 Weeks|Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28645|NCT01628601|Secondary|Physician Assessment of Adherence to GANfort®|"Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported."|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28646|NCT01628601|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28647|NCT01628601|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28648|NCT01628601|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 18 Weeks|All enrolled patients with complete data for this outcome measure||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
28649|NCT01628588|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28650|NCT01628588|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28651|NCT01628588|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28652|NCT01628588|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure||Participants|||Number
28653|NCT01628588|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
28654|NCT01628510|Secondary|The Bayley Scales of Infant Development-3rd Edition (BSID-III)|The BSID-III is the gold standard for assessing developmental outcome in childhood. Domain scores for language, motor and cognition will be determined.|6 months, 1 year, 2 years and 3 years||||||
28655|NCT01628510|Primary|NICU Network Neurobehavioral Scale (NNNS)|The NNNS wasl used to assess neurobehavioral outcome near term equivalent (between 35 weeks and 41 weeks postmenstrual age). This tool consists of eliciting neonatal reflexes and observing behavior. From the assessment, 13 summary scores were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.|35 to 41 weeks (term equivalent); prior to NICU discharge|||Asymmetry Score (units on a scale)||Standard Deviation|Mean
28656|NCT01628367|Secondary|Pink Esthetic Score|Pink esthetic score per Furhauser et.al. measured at study conclusion where based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture (Fig. 1). Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. Thus a maximum score of 14 is best, and 0 is the worst.|One year|||units on a scale||Standard Deviation|Mean
28657|NCT01628367|Secondary|Change in Interproximal Bone Levels|Mean interproximal marginal bone loss (mean of mesial and distal sites))|One year|||millimeters||Standard Deviation|Mean
28658|NCT01628367|Primary|Change in Thickness of Buccal Bone|Loss of buccal bone volume over study duration|One year|||millimeters||Standard Deviation|Mean
28659|NCT01628250|Secondary|Survival Rate|The follow up to the patients after the surgery to evaluate the oncological results of the technique|3 years after the surgery||||||
28660|NCT01628250|Primary|Histopathological Outcomes Obtained Through the Surgeries|number of lymph nodes retrieved|14 days after the surgery|||nodes||Standard Deviation|Mean
28661|NCT01628042|Primary|Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||L/hr||95% Confidence Interval|Geometric Mean
28746|NCT01626820|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
28662|NCT01628042|Primary|Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
28663|NCT01628042|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.||nM•hr||95% Confidence Interval|Geometric Mean
28664|NCT01627860|Secondary|Dosage Administration of Topamax During Month 4||Month 4|Participants who have received study medication during month 4.||mg||Standard Deviation|Mean
28665|NCT01627860|Secondary|Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4|Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.|Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.||Percent change||Standard Deviation|Mean
28666|NCT01627860|Primary|Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).||Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
28667|NCT01627782|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||hour||Standard Deviation|Mean
28668|NCT01627782|Secondary|Volume of Distribution at Steady-State (Vss) of Ketamine|The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of ketamine at steady state.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||liter||Standard Deviation|Mean
28669|NCT01627782|Secondary|Total Systemic Clearance (CL) of Ketamine|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||liter per hour||Standard Deviation|Mean
28670|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||hour*nanogram per milliliter||Standard Deviation|Mean
28671|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])|The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||hour*nanogram per milliliter||Standard Deviation|Mean
28672|NCT01627782|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine|The Tmax is defined as actual sampling time to reach maximum observed drug concentration.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Hour||Full Range|Median
28783|NCT01625845|Secondary|Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment|An anti-inflammatory cytokine measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One participant, with extreme outlier values at pre- and post-treatment, was excluded from analyses.||pg/mL||Standard Error|Mean
28673|NCT01627782|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ketamine|The Cmax is the maximum observed plasma concentration of drug.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
28674|NCT01627782|Secondary|Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase|The PGI-C is a 7-point scale that required the subject to assess how much their illness had improved or worsened relative to a baseline state at the beginning of the intervention. The response options were: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse. The scale is rated as, 1=very much improved and 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Units on a scale||Full Range|Median
28675|NCT01627782|Secondary|Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29)|The PGI-S is an 11-point (0 to 10) scale that required the participant to rate the severity of their illness at the time of assessment, relative to the participants past experience. Considering their total experience, the participant was to assess the severity of their depression illness at the time of rating as none, mild, moderate or severe. The scale is rated as, 0=very well and 10=very poor.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Full Range|Median
28676|NCT01627782|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase|The CGI-I is a 7-point scale that was used to assess how much the participants illness was improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 0= not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Units on a scale||Full Range|Median
28677|NCT01627782|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)|The CGI-S was used to rate the severity of the participants illness at the time of assessment, relative to the clinician’s past experience with participants who had the same diagnosis and improvement with treatment. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to: 0= not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Full Range|Median
28678|NCT01627782|Secondary|Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Sustained response on Day 15 was defined as achieving an onset of antidepressant response within the first week that is maintained to the end of study Day 15. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Participants|||Number
28679|NCT01627782|Secondary|Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants who had a MADRS total score of less than or equal to (<=) 10 were considered remitters. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Participants|||Number
28680|NCT01627782|Secondary|Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants with a reduction in the MADRS total score of greater than or equal to (>=) 50 percent from baseline were defined as responders. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Participants|||Number
28784|NCT01625845|Secondary|Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||pg/mL||Standard Error|Mean
28681|NCT01627782|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Standard Deviation|Mean
28682|NCT01627782|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively||Units on a scale||Standard Deviation|Mean
28683|NCT01627561|Secondary|The Number of Subjects Completing the Vaccination Schedule in All Groups.||From first vaccination to the last vaccine dose (from Day 0 up to Month 6)|||Subjects|||Number
28684|NCT01627561|Secondary|Number of Subjects Reporting the Intake of Concomitant Medication||During the 43-day period (Days 0-42) following vaccination on Day 0 and during the 30-day period (Days 0-29) following vaccination at Month 6|||Subjects|||Number
28685|NCT01627561|Secondary|The Occurrence of Pregnancy and Pregnancy Outcomes in Group HPV_3D.||From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)||12/2016||||
28686|NCT01627561|Secondary|The Occurrence of AEs/SAEs Leading to Withdrawal in All Groups.||Throughout the study period (From Day 0 to Month 36)||12/2016||||
28687|NCT01627561|Secondary|The Occurrence of SAEs Related to the Investigational Products, to Study Participation, to GSK Concomitant Products or Any Fatal SAE in All Groups.||Throughout the study period (From Day 0 to Month 36)||12/2016||||
28688|NCT01627561|Secondary|The Occurrence of SAEs in All Groups.||From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)||12/2016||||
28689|NCT01627561|Secondary|The Occurrence of MSCs in All Groups.||From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)||12/2016||||
28690|NCT01627561|Secondary|The Occurrence of pIMDs in All Groups.||From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)||12/2016||||
28691|NCT01627561|Secondary|The Number of Subjects With Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism, Including Febrile Convulsion||During the 43-day period (Days 0-42) following vaccination on Day 0|||Subjects|||Number
28692|NCT01627561|Secondary|Seroprotection Rates to Diphtheria (D) and Tetanus (T) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||At Month 7||12/2016||||
28693|NCT01627561|Secondary|Vaccine Response Rates to Filamentous Haemagglutinin (FHA), Pertactin (PRN) and Pertussis Toxoid (PT) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||At Month 7||12/2016||||
28694|NCT01627561|Secondary|Anti-measles, Mumps and Rubella Antibody Titres in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||On Days 0 and 42||12/2016||||
28695|NCT01627561|Secondary|Anti-measles, Mumps and Rubella Seropositivity Rates in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||On Days 0 and 42||12/2016||||
28696|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
28697|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
28698|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Group MMR_DTPa||At Day 0, Month 7 and Month 12||12/2016||||
28699|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-Based Neutralization Assay (PBNA) in a Sub-cohort in Group MMR_DTPa||At Day 0, Month 7 and Month 12||12/2016||||
28700|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
28701|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||12/2016||||
28702|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by ELISA in Group MMR_DTPa||At Day 0, Month 7 and Month 12||12/2016||||
28703|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA in Group MMR_DTPa||At Day 0, Month 7 and Month 12||12/2016||||
28704|NCT01627561|Primary|Anti HPV-18 Antibody Titers|Antibody titers were assessed by Enzyme-linked-Immunosorbent Assay (ELISA) and expressed as geometric mean titers (GMTs) in ELISA units per milliliter (EU/mL).|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||Titers||95% Confidence Interval|Geometric Mean
28705|NCT01627561|Primary|Anti-HPV-16 Antibody Titers|Antibody titres were assessed by Enzyme-linked-Immunosorbent Assay (ELISA) and expressed as geometric mean titers (GMTs) in ELISA units per milliliter (EU/mL).|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||EU/mL||95% Confidence Interval|Geometric Mean
28785|NCT01625845|Secondary|Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and12 weeks|Participants with missing TNF-a data were excluded from this analysis.||pg/mL||Standard Error|Mean
28706|NCT01627561|Primary|Number of Serconverted Subjects for Anti-HPV-18|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
28707|NCT01627561|Primary|Number of Serconverted Subjects for Anti-HPV-16|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
28708|NCT01627561|Primary|Number of Subjects With Medically Significant Conditions (MSCs)||From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
28709|NCT01627561|Primary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)||From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
28710|NCT01627561|Primary|Number of Subjects With AEs and SAEs Leading to Withdrawal||From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
28711|NCT01627561|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)|||Subjects|||Number
28712|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters||42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.||Subjects|||Number
28713|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters.||42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.||Subjects|||Number
28714|NCT01627561|Primary|Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination Dose 2 at Month 6|Note: Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from the TVc.||Subjects|||Number
28715|NCT01627561|Primary|Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 43-day period (Days 0-42) post vaccination Dose 1|||Subjects|||Number
28716|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) following each vaccination|||Subjects|||Number
28717|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) following each vaccination|||Subjects|||Number
28718|NCT01627340|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Month 0 - Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.||Subjects|||Number
28719|NCT01627340|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.||Subjects|||Number
28720|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Any fever = oral temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.||Subjects|||Number
28721|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.||Subjects|||Number
28722|NCT01627340|Secondary|Anti-HBs Antibody Concentration|Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.||mIU/mL||95% Confidence Interval|Geometric Mean
28723|NCT01627340|Primary|Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies|A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.||Subjects|||Number
28724|NCT01627327|Secondary|Change From Baseline in Trough FEV1 at Treatment Day 84|Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|ITT Population. Only participants with data available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
28725|NCT01627327|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.|Baseline and Day 1|ITT Population. Only participants with data available at the indicated time point were assessed.||Minutes||Full Range|Median
28726|NCT01627327|Primary|Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Only participants with data available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
28727|NCT01627249|Secondary|Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser||Baseline to 1-year|||Eyes|||Number
28728|NCT01627249|Secondary|Total Number of Laser Treatments|Only includes participants that completed the 1 year visit.|between 24 weeks and 1 year|||participants|||Number
28729|NCT01627249|Secondary|Total Number of Injections Prior to 1 Year|Only includes participants that completed the 1 year visit|Baseline to 1-year|Seven study eyes received 1 injection and 2 eyes received 2 injections of 0.5 mg of ranibizumab prior to the FDA approving a 0.3 mg dosage of ranibizumab for diabetic macular edema treatment.||Injections||Standard Deviation|Mean
28730|NCT01627249|Secondary|Overall Change in Retinal Volume|Baseline volume values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 459 scans. One-year volume values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 472 scans. When calculating change in volume, measurements taken on the same machine at both visits were not converted, because the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in volume was calculated after converting either the baseline and/or follow-up value from Spectralis or Cirrus to a Stratus equivalent value in 17 eyes.|Baseline to 1-year|In addition to participants missing the 1-year visit, 46 in the aflibercept group, 53 in the bevacizumab group, and 44 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||mm^3||Standard Deviation|Mean
28745|NCT01626820|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
28731|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||microns||Standard Deviation|Mean
28732|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||microns||Standard Deviation|Mean
28733|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).||units on a scale||Standard Deviation|Mean
28734|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).||units on a scale||Standard Deviation|Mean
28735|NCT01627249|Secondary|Overall Change in Optical Coherence Tomography Central Subfield Thickness|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.||microns||Standard Deviation|Mean
28736|NCT01627249|Primary|Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).||units on a scale||Standard Deviation|Mean
28737|NCT01627002|Secondary|Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose|||percentage of total cells||95% Confidence Interval|Least Squares Mean
28738|NCT01627002|Primary|Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose|||x10e6 cells/g||95% Confidence Interval|Least Squares Mean
28739|NCT01627002|Secondary|Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity||Up to 12 time-points up to 48 hours post dose|||ng.h/mL||Standard Deviation|Mean
28740|NCT01627002|Secondary|Pharmacokinetic Parameters: Terminal Half-life (t1/2)||Up to 12 time-points up to 48 hours post dose|||hours||Standard Deviation|Mean
28741|NCT01627002|Secondary|Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)||Up to 12 time-points up to 48 hours post dose|||hours||Standard Deviation|Mean
28747|NCT01626820|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever [oral temperature ≥38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination, Any fever = oral temperature ≥38.0 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed||Subjects|||Number
28748|NCT01626820|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling were defined as ecchymosis, induration, redness and swelling above 100 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.||Subjects|||Number
28749|NCT01626820|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Mean
28750|NCT01626820|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
28751|NCT01626820|Primary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Subjects|||Number
28752|NCT01626820|Primary|Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Mean
28753|NCT01626690|Secondary|Temporal Artery Verus SpotOn (3M) Temperature Readings.|Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
28754|NCT01626690|Secondary|Incidence of Perioperative Cardiac Events.|Incidence of perioperative arrhythmias or myocardial ischemia.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Patients|||Number
28755|NCT01626690|Secondary|Intraoperative Blood Loss.|Intraoperative blood loss in mL's.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||mL||Standard Deviation|Mean
28756|NCT01626690|Secondary|Incidence of Postoperative Shivering in Recovery Room.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Number of patients reporting shivering|||Number
28757|NCT01626690|Secondary|Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
28758|NCT01626690|Secondary|Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
28759|NCT01626690|Secondary|Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
36467|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ABPM record||mmHg||Standard Deviation|Mean
28760|NCT01626690|Primary|Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..|Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).|||Degrees Celsius||Standard Deviation|Mean
28761|NCT01626456|Secondary|Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).|52 weeks|The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.||units on a scale||Standard Deviation|Mean
28762|NCT01626456|Secondary|Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests|Includes incidence >2% but <5%.|52 weeks|||participants|||Number
28763|NCT01626456|Secondary|Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.||participants|||Number
28764|NCT01626456|Secondary|Discontinuation From Study Due to Adverse Events (AEs)|Number of subjects who discontinued the study due to AE.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.||participants|||Number
28765|NCT01626456|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data."|52 weeks|The full analysis set consists of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.||units on a scale||Standard Deviation|Mean
28766|NCT01626456|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|This measure includes incidences >5%.|52 weeks|Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.||participants|||Number
28767|NCT01626391|Primary|Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine|This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.|8 weeks|Safety Population||participants|||Number
28768|NCT01626118|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||units on a scale*hour||Standard Deviation|Mean
28769|NCT01626118|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||units on a scale*hour||Standard Deviation|Mean
28770|NCT01626118|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||units on a scale*hour||Standard Deviation|Mean
31110|NCT01586364|Primary|Change From Baseline in E2 Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||pg/mL||Standard Deviation|Mean
28771|NCT01626118|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0."|0-4 hours|||units on a scale*hour||Standard Deviation|Mean
28772|NCT01626118|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
28773|NCT01626118|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
28774|NCT01626118|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-4 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
28775|NCT01626118|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.||mm*hour||Standard Deviation|Mean
28776|NCT01626092|Secondary|Neurologic Outcomes|Depending upon underlying primary disease, a combination of evaluative tools (e.g. brain magnetic resonance imaging (MRI), clinical neurologic exam, neuropsychologic testing, electromyography) will be applied for assessment of neurologic function and how it may be affected by this reduced-intensity HCT regimen.|Changes from Baseline, Days 30, 60, 100, Year 1, Year 2, Year 3 Following HCT|None of the 3 patients enrolled in the study were evaluable for this outcome. Two had a repeat transplant and one was lost to follow-up.|||||
28777|NCT01626092|Secondary|Transplant-Related Mortality|Incidence of death due to complications of HCT following this reduced-intensity conditioning regimen.|Day 100 following HCT|||participants|||Number
28778|NCT01626092|Primary|Donor (Allogeneic) Hematopoietic Engraftment|Number of patients who achieve hematopoietic engraftment - assessment of nucleated peripheral blood cells for donor (allogeneic) chimerism following this reduced-intensity HCT.|Day 100 Following Hematopoietic Cell Transplant (HCT)|||participants|||Number
28779|NCT01625910|Secondary|Sugar Sweetened Beverages|Change in reported intake of sugar sweetened beverages|Three months|Intention to treat analysis||cans per day||Standard Error|Mean
28780|NCT01625910|Primary|Body Mass Index Z-score Change|Change in body mass index z-score change over the three month time period|Three months|All enrolled were analyzed with one exception (due to injury and prolonged cast treatment). An intent-to-treat analysis required that, for those who did not have the follow-up measurement, data were filled in using the experience of those in the control group who had follow-up measurements.||BMI z-score change||Standard Error|Mean
28781|NCT01625845|Secondary|Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||mg/L||Standard Error|Mean
28782|NCT01625845|Secondary|Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||pg/mL||Standard Error|Mean
28786|NCT01625845|Primary|Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 weeks|||Change in Total Score||Standard Error|Mean
28787|NCT01625845|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation|0 and 12 weeks|||% change in brachial diameter||Standard Error|Mean
28788|NCT01625689|Secondary|Viral Etiologies of Acute Respiratory and Febrile Illness Will be Parameterized as the Percentage of Those With Each Particular Laboratory-confirmed Respiratory Virus Infection Categorized by Vaccine Allocation||6 months post-vaccination||||||
28789|NCT01625689|Secondary|Clinical Characteristics of Influenza, Including Influenza Coinfections With Other Bacterial and Viral Respiratory Pathogens, Will be Parameterized as the Percentage of Participants Categorized by Vaccine Allocation||6 months post-vaccination||||||
28790|NCT01625689|Secondary|Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day.||2, 4, and 7 days post-vaccination||||||
28791|NCT01625689|Secondary|The Post-vaccination Anti-influenza Immunologic Response Will be Measured Based on the Type of Immunologic Assay and Categorized by Vaccine Virus Strain, Participant Baseline Serostatus, and Vaccine Allocation||Approximately 21 days post-vaccination||||||
28792|NCT01625689|Primary|Percentage of Participants With Solicited Local and Systemic Reactions|"Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain~Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy"|Through 7 days following vaccination|Safety analysis population||percentage of participants|||Number
28793|NCT01625689|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)||Throughout study period, through at least 6 months following vaccination|||percentage of participants|||Number
28794|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician~Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)~Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|42 days following vaccination||||||
28795|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician~Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)~Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|6 months following vaccination|Safety analysis population||participants|||Number
28796|NCT01625507|Secondary|Change in Waist Circumference|Measured using repeated 24 hour dietary recalls (pre and post-intervention|4 months|||cm||95% Confidence Interval|Mean
28797|NCT01625507|Secondary|Food Availability|questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.|4 months||||||
28798|NCT01625507|Secondary|Food Accessibility|questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes|4 months||||||
28799|NCT01625507|Secondary|Food Acceptability|questionnaire based on items related to personal and cultural acceptability of the recommended diet|4 months||||||
28800|NCT01625507|Secondary|Change in Perceived Dietary Adherence Questionnaire Score|Questionnaire assessing self-reported adherence to 9 criteria, whose individual scores (range 0-7) are summed to get the total score. Maximum total score is 63. Minimum total score is 0. A higher score means higher dietary adherence.|4 months|||units on a scale||95% Confidence Interval|Mean
28801|NCT01625507|Secondary|Change in Blood Biomarkers|blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol|4 months|||mg/dL||95% Confidence Interval|Mean
28802|NCT01625507|Secondary|Body Composition|body fat and fat-free mass|3 months|||percentage change from baseline||95% Confidence Interval|Mean
28803|NCT01625507|Secondary|Change in Body Mass Index|Actual weight and height used to calculate BMI pre- and post-intervention|4 months|||kg/m2||95% Confidence Interval|Mean
28804|NCT01625507|Secondary|Program Retention|attendance at meetings|3 months|||Participants|||Count of Participants
28805|NCT01625507|Secondary|Change in Hemoglobin A1c|a surrogate of blood glucose control|4 months|||percentage of hemoglobin A1c||95% Confidence Interval|Mean
28806|NCT01625507|Primary|Change in Nutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months|||grams||95% Confidence Interval|Mean
28807|NCT01625507|Primary|Change in Macronutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months|||percentage of total energy||95% Confidence Interval|Mean
28808|NCT01625507|Primary|Change in Total Energy Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|4 months|All participants, intention to treat protocol||kcal||95% Confidence Interval|Mean
31111|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||ng/dL||Standard Deviation|Mean
28809|NCT01625377|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation|Baseline was Day 28 visit. This endpoint reports patients with total adverse events (any), serious adverse events, death and premature discontinuation.|Baseline to 24 weeks|The safety population included all randomized patients who received at least one dose of study treatment post-randomization and for whom there was a post-treatment safety assessment.||Patients|||Number
28810|NCT01625377|Secondary|Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System|"Kidney disease outcomes quality initiative (K/DOQI) classification is based on glomerular filtration rate (GFR), abbreviated MDRD formula (mL/min/1.73m^2) :~Stage 1 : GFR >= 90; Stage 2 = GFR was between 60-89; Stage 3 = GFR was between 30-59 ; Stage 4 = GFR was between 15-29; Stage 5 = GFR was < 15 (or dialysis)"|At Week 24|ITT population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available.||Patients|||Number
28811|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula|"GFR estimated by using the Chronic kidney disease- epidemiology (CKD-EPI) formula:~eGFR (mL/min/1.73m^2) = 141 * min(C/K,1)^ α * max(C/K,1)^-1.209 * 0.993^A * 1.1018 (if male) * 1.159 (if black) where C = serum creatinine (in mg/dL) ; A = Age (in years); K = 0.7 for women and 0.9 for men; α = -0.329 for women and -0.411 for men. Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Deviation|Mean
28812|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula|"Change in glomerular filtration rate was calculated using the MDRD abbreviated formula.~GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Deviation|Mean
28813|NCT01625377|Secondary|Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula|Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit.|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Deviation|Mean
28814|NCT01625377|Secondary|Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio|Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit.|Baseline, week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom urine protein and creatinine value at day 28 and a posterior value were available. LOCF applied.||mg/mmol||Standard Deviation|Mean
28815|NCT01625377|Secondary|Change From Baseline (Randomization) in Serum Creatinine|"Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function.~Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||µmol/L||Standard Deviation|Mean
28816|NCT01625377|Secondary|Number of Patients With Death or Graft Loss|The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft.|at week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.||Patients|||Number
28817|NCT01625377|Secondary|Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3|"Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.~The patients with treated or untreated BPAR having RAI score > 3 were reported in this end point."|At 24 weeks|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.||Patients|||Number
28818|NCT01625377|Secondary|Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification|"Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.~The severity of BPAR was categorized as :~Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted."|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.||Patients|||Number
28819|NCT01625377|Secondary|Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR)|Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.||Patients|||Number
28820|NCT01625377|Secondary|Number of Patients With Treatment Failures|"Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification >3, graft loss or death at 6 months.~Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.~The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft."|At week 12 and week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.||Patients|||Number
28821|NCT01625377|Primary|Change From Baseline (Randomization) in Renal Function|"Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula.~GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value a Day 28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.||mL/min/1.73m^2||Standard Error|Least Squares Mean
28822|NCT01625338|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
28823|NCT01625338|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
28824|NCT01625338|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set||percentage of participants|||Number
28825|NCT01625338|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
28826|NCT01625338|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug.||percentage of participants|||Number
28827|NCT01625221|Primary|Reduction in Fecal Incontinence Symptoms|Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.|12 Months|||episodes per week||Standard Deviation|Mean
28828|NCT01625221|Primary|Serious Adverse Events|The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.|12 months||||||
28829|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 14|One participant did not complete D14 visit.||participants|||Number
28830|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 5|One participant did not complete Visit D5.||participants|||Number
28831|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 14|One participant did not complete D14 visit.||ng*hr/ml||Standard Deviation|Mean
28832|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 5|One participant did not complete D5 visit.||ng*hr/ml||Standard Deviation|Mean
28833|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 14: 0, 2,4, 8 and 24 hours post dose|One participant did not complete D14 visit.||ng*hr/ml||Standard Deviation|Mean
28834|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 5: 0, 2,4, 8 and 24 hours post dose|One participant did not complete Day 5 visit.||ng*hr/ml||Standard Deviation|Mean
28835|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.||ng/ml||Standard Deviation|Mean
28836|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.||ng/ml||Standard Deviation|Mean
28837|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|"Cmax ng/ml~Note: One participant did not complete the Day 5 evaluation."|day 5|Note: One participant did not complete the Day 5 evaluation.||ng/ml||Standard Deviation|Mean
28838|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|"Cmax ng/ml~Note: One participant did not complete the Day 5 evaluation."|Day 5|Note: One participant did not complete the Day 5 evaluation.||ng/ml||Standard Deviation|Mean
28839|NCT01624948|Secondary|Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes|"Measurement of the expression of three NFAT-regulated genes IL-2, interferon gamma, and GM-CSF, to predict a rejection episode.~The residual gene expression after Tacrolimus intake was calculated as T1.5/T0*100, where T0 is the adjusted number of transcripts at Tacrolimus pre-dose level and T1.5 is the number of transcripts 1.5 hours after drug intake. For all three genes the residual expression was averaged and presented as “MRE of NFAT-regulated genes.”"|3 months post-randomization|a subset of 19 participants enrolled in the immune-monitoring portion of the study||percent residual expression||95% Confidence Interval|Median
28840|NCT01624948|Secondary|Proteinuria||3 months post-randomization|||g/g creatinine||Standard Deviation|Mean
28841|NCT01624948|Secondary|Cholesterol||3 months post-randomization|||mg/dL||Standard Deviation|Mean
28842|NCT01624948|Secondary|p70S6 Kinase Phosphorylation||3 months post-randomization|19 patients enrolled in the immune-monitoring subset; 1 participant did not have a 3-month assay.||Mean Fluorescence Intensity||95% Confidence Interval|Median
28843|NCT01624948|Secondary|Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels|A doubling of BK viremia levels or the development of BKV nephropathy in subjects enrolled in the experimental study arm will prompt a conversion to standard care therapy. We will closely monitor BKV levels in the urine and blood and assess renal function monthly, as per our usual standard of care. Based on BKV results as well as renal function, as assessed by serum Cr, biopsies may be done for cause. Patients will have a final visit at month 4 to monitor for adverse events.|3 months post-randomization|||participants|||Number
28844|NCT01624948|Primary|Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia|composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization|3 months post-randomization|||participants|||Number
28845|NCT01624740|Primary|Change in Back Pain Intensity|"Back pain intensity was measured on a 0-10 numerical rating scale (0=no pain, 10=worst pain imaginable) at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation."|For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).|||Percent Change From Baseline||Standard Deviation|Mean
28846|NCT01624467|Secondary|Number of Participants With an Incidence of Anti-Necitumumab Antibodies||Baseline to Post Infusion 30 Day Follow-up|All participants who received at least 1 dose of study drug and had at least 1 post-infusion blood sample.||participants|||Number
28847|NCT01624467|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1,CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.|Baseline to Measured Progressive Disease (up to 21 Months)|All participants who received any study drug and had CR or PR.||percentage of participants||95% Confidence Interval|Number
28848|NCT01624467|Secondary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab||Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1, Days 1 and 36.||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
28849|NCT01624467|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞])||Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1 on Days 1 and 36.||microgram*hour/milliliter (μg*h/ml)||Geometric Coefficient of Variation|Geometric Mean
28850|NCT01624467|Secondary|Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR])|Change in HR from time-matched measures performed at baseline.|Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG||Beats/minute||Standard Deviation|Mean
28851|NCT01624467|Secondary|PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.||percentage of participants|||Number
28852|NCT01624467|Secondary|Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG||participants|||Number
28853|NCT01624467|Primary|Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)|The corrected QT interval was calculated using Fridericia’s correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant’s corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval|Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.||milliseconds (msec)||90% Confidence Interval|Mean
28854|NCT01624350|Secondary|Pain|Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.|Baseline, 1 month, 3 months, 6 months and 12 months|Participants include number of patients who completed questionnaire||Participants|||Count of Participants
30820|NCT01591616|Secondary|Vital Signs (Pulse)|Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.|Pre-dose and every 10 minute to 240 minutes post-dose.|||Beats per minute||Full Range|Mean
28855|NCT01624350|Secondary|Patient Satisfaction Between the First and Last Post-operative Visit|Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.|Between the first and last visits|Number of participants completed a satisfaction questionnaire at least twice.||Participants|||Count of Participants
28856|NCT01624350|Secondary|Fecal Incontinence|Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.|3 months, 6 months and 12 months|The CCF-FI score was calculated if a score was ticked for each of the five types of incontinence. If a patient had a type of incontinence with a missing score, then the CCF-FI score was not calculated. Change = Value and Month X - Value at Baseline.||units on a scale||Standard Deviation|Mean
28857|NCT01624350|Secondary|Participant Response to Quality of Life EQ-5D Questionnaire|Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.|Baseline, and 3 months, 6 months and 12 months post op|Number analyzed include participants who completed questionnaire.||participants|||Number
28858|NCT01624350|Secondary|Fistula Healing in Patients at 3 and 12 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|3 months and 12 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.||percentage of patients||95% Confidence Interval|Number
28859|NCT01624350|Primary|Fistula Healing in Patients at 6 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|6 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.||percentage of participants|||Number
28860|NCT01624259|Secondary|Percent Change From Baseline in Lipid Parameters at 26 Weeks|A summary of percent change in lipid parameters (total cholesterol, high-density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], very low-density lipoprotein cholesterol [VLDL], and triglycerides) from baseline to primary endpoint of 26 weeks is presented. LS means of the lipid parameter from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and lipid parameter baseline as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipid laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percent||Standard Error|Least Squares Mean
28861|NCT01624259|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose|LY2189265 (dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation in dulaglutide-treated participants. A participant was considered to have treatment emergent LY2189265 ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The number of participants with treatment-emergent LY2189265 ADA from postbaseline to follow up were summarized.|Baseline up to 4 Weeks Post Last Dose of Study Drug|Participants who were randomized and received at least 1 dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
28862|NCT01624259|Secondary|Number of Participants With Allergic or Hypersensitivity Reactions|Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adverse event data.||participants|||Number
28863|NCT01624259|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.||weeks||95% Confidence Interval|Median
28864|NCT01624259|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|HE were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). The hypoglycemia rate per 30 days was calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemic episode data. Only pre-rescue measurements were used.||number of events/participant/30 days||Standard Deviation|Mean
28886|NCT01624233|Secondary|Change From Baseline in Itch NRS Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 100; Baseline, Wk 292||06/2017||||
28865|NCT01624259|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.||percentage of participants|||Number
28866|NCT01624259|Secondary|Percentage of Participants With Self-Reported Hypoglycemia Events|"Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a plasma glucose [PG] concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL).~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemia event data. Only pre-rescue measurements were used.||percentage of participants|||Number
28867|NCT01624259|Secondary|Change From Baseline in Amylase at 26 Weeks|A summary of participants having changes in amylase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable amylase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||U/L||Inter-Quartile Range|Median
28868|NCT01624259|Secondary|Change From Baseline in Lipase at 26 Weeks|A summary of participants having changes in lipase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units/liter (U/L)||Inter-Quartile Range|Median
28869|NCT01624259|Secondary|Change From Baseline in Calcitonin at 26 Weeks|A summary of participants having changes in calcitonin values from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable calcitonin laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms/milliliter (pcg/mL)||Inter-Quartile Range|Median
28870|NCT01624259|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 26 weeks (including a 30-day follow up). Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline up to 30 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable adverse event data.||participants|||Number
28871|NCT01624259|Secondary|Change From Baseline in Blood Pressure (BP) at 26 Weeks|Descriptive statistics for the actual measurements and change from baseline for sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline BP as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BP data.||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
28872|NCT01624259|Secondary|Change From Baseline in Heart Rate (HR) at 26 Weeks|Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the MMRM model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable heart rate data.||bpm||Standard Error|Least Squares Mean
28873|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QTcF is the measure of the time between the start of the Q wave and the end of the T wave adjusted using Fridericia's formula. PR is the interval between the P wave and the QRS complex. These parameters were calculated from electrocardiogram (ECG) data. LS means of change from baseline for the PR and QTcF intervals will be analyzed using the MMRM similar to MMRM model for primary outcome, using corresponding baseline and HbA1c strata. Only ECGs obtained at scheduled visits will be used in these summaries and analyses.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable ECG PR or QTcF interval data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milliseconds (msec)||Standard Error|Least Squares Mean
28874|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks|ECG HR was measured. LS means of change from baseline were analyzed using ANCOVA with HbA1c strata, country, and treatment as fixed effects and baseline HR as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable ECG heart rate data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||beats per minute (bpm)||Standard Error|Least Squares Mean
28885|NCT01624233|Secondary|Change From Baseline in DLQI Score|DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant.|Baseline, Wk 100; Baseline, Wk 292||06/2017||||
28875|NCT01624259|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular (CV) adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal CV AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with reported CV events, number of participants with nonfatal CV events confirmed by adjudication, and number of deaths confirmed by adjudication are summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adjudicated CV event data.||participants|||Number
28876|NCT01624259|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks|"The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%.~LS means of the HOMA2-%B change from baseline to primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline HOMA2-%B value as covariate, via an ANCOVA analysis using LOCF."|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable HOMA2-%B data. LOCF was used to impute missing postbaseline values. If there was no data after date of randomization, the endpoint was considered missing.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
28877|NCT01624259|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks|The percentage of participants who achieved the target HbA1c values at the primary endpoint were analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes pooled country, treatment, visit, treatment-by-visit interaction, and baseline HbA1c as continuous covariates.|Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
28878|NCT01624259|Secondary|Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks|"The SMPG data were collected at the following 7 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; and bedtime. The mean of the 7 time points (Daily Mean) was also calculated.~LS means of the SMPG change from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, HbA1c strata, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG as a covariate, via a MMRM analysis using REML."|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable 7-Point SMPG data. Only pre-rescue measurements were used.||mg/dL||Standard Error|Least Squares Mean
28879|NCT01624259|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks|LS means of the FPG from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FPG as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|"Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable FPG data. Only pre-rescue measurements were used.~LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing."||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
28880|NCT01624259|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means of the BMI change from baseline to primary endpoint at Week 26 were calculated using ANCOVA with HbA1c Strata, country, and treatment as fixed effects and baseline BMI as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BMI data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||kilograms/square meter (kg/m^2)||Standard Error|Least Squares Mean
28881|NCT01624259|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means of the weight change from baseline to primary endpoint at Week 26 were calculated using analysis of covariance (ANCOVA) with HbA1c Strata, country, and treatment as fixed effects and baseline body weight as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
28882|NCT01624259|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
28883|NCT01624233|Secondary|Number of Participants Achieving ACR20|ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR.|Wk 100 and Wk 292||06/2017||||
28884|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain VAS|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 100; Baseline, Wk 292||06/2017||||
28887|NCT01624233|Secondary|Change From Baseline in QIDS-SR16 Score|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 100; Baseline, Wk 292||06/2017||||
28888|NCT01624233|Secondary|Change From Baseline in PSSI|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 100; Baseline, Wk 292||06/2017||||
28889|NCT01624233|Secondary|Change From Baseline in NAPSI|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.|Baseline, Wk 100; Baseline, Wk 292||06/2017||||
28890|NCT01624233|Secondary|Change From Baseline in Percent of BSA Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 100; Baseline, Wk 292||06/2017||||
28891|NCT01624233|Secondary|Percentage of Participants With sPGA (0 or 1) and sPGA (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wks 100 and 292||06/2017||||
28892|NCT01624233|Secondary|Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 100 and 292||06/2017||||
28893|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 12; Baseline, Wk 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.||mm||Standard Deviation|Mean
28894|NCT01624233|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).|Wks 12, 24 and 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.||participants|||Number
28895|NCT01624233|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score|DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
28896|NCT01624233|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS) Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
28919|NCT01623830|Primary|The Questionnaire on Attitudes Toward Flying (QAF)|assesses history of FOF, previous treatment, and attitudes toward flying. It includes a 36-item questionnaire rating the level of fear on an 11-point scale ranging from 0 to10 in different flying situations. The possible range of scores is 0 to 360 with higher scores indicating greater fear associated with flying. Test-retest reliability was .92, and split-half reliability was .99.|post treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
28897|NCT01624233|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
28898|NCT01624233|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
28899|NCT01624233|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.||units on a scale||Standard Deviation|Mean
28900|NCT01624233|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).||percentage of BSA||Standard Deviation|Mean
28901|NCT01624233|Secondary|Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.||percentage of participants|||Number
28902|NCT01624233|Secondary|Percent of Participants Achieving PASI 90% and 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.||percentage of participants|||Number
28903|NCT01624233|Secondary|Number of Participants With Anti-Ixekizumab Antibodies|Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.|Baseline through Wk 52|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.||participants|||Number
28904|NCT01624233|Secondary|Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab|PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.|Wks 12 and 24|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
28920|NCT01623830|Primary|Fear of Flying Inventory (FFI)|a 33-item scale measuring intensity of FOF. Items are rated on a 9-point scale ranging from 0 ( not at all) to 8 ( very severely disturbing). The possible range of scores is 0-264 with higher total scores indicating greater fear of flying intensity.Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment.|Post treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
37003|NCT01493531|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12.|12 Months|||Gout Flares||Standard Deviation|Mean
28905|NCT01624233|Secondary|Percentage of Participants Achieving ≥75% Improvement in PASI|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.||percentage of participants|||Number
28906|NCT01624233|Primary|Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week (Wk) 12|All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
28907|NCT01624168|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index Scores|Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.|baseline, 4 weeks, 10 weeks, 2 month follow-up|||units on a scale||Standard Error|Mean
28908|NCT01624168|Secondary|Change From Baseline in State Anxiety Scores|Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.|change from baseline to 4 weeks, 10 weeks, 2 month follow-up|||units on a scale||Standard Error|Mean
28909|NCT01624168|Primary|Adherence to Practice After the Intervention|Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.|2 months|||participants|||Number
28910|NCT01624168|Primary|Adherence to Out-of-class Practice|Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention|10 weeks|||participants|||Number
28911|NCT01624168|Primary|Retention of Randomized Subjects for Follow-up|Subjects retained for follow-up are those willing to respond to follow-up assessments|2 months|||participants|||Number
28912|NCT01624168|Primary|Retention of Randomized Subjects During Intervention|Retained subjects are those who are willing to return for complete assessments|10 weeks|||participants|||Number
28913|NCT01623869|Secondary|OS|Overall survival (OS) is the duration of time from the date of registration/randomization to the date of death or the date of last follow-up for patients who remain alive or who are lost to follow-up at the time of the analysis. Kaplan-Meier methodology will be used to estimate the distribution of OS.|From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months|||months||95% Confidence Interval|Median
28914|NCT01623869|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) is defined as the duration of time from the start of treatment to time of radiologic or clinical progression or death, whichever occurs first. PFS will be censored at most recent radiographic assessment date for patients remaining alive at the time of the statistical analysis. Kaplan-Meier methodology will be used to estimate the distribution of PFS.|From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months|||months||95% Confidence Interval|Median
28915|NCT01623869|Primary|Confirmed Response Rate (CR or PR) Using RECIST|"Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response.~Complete Response (CR) - All of the following must be true:~Disappearance of all target and non-target lesions,~Each target lesion and non-target lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR):~At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation.~Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner."|Up to 18 months|||percentage of participants||95% Confidence Interval|Number
28916|NCT01623830|Secondary|State Trait Anxiety Inventory- Trait (STAI-Trait)|The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety. Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
28917|NCT01623830|Secondary|State Trait Anxiety Inventory- State (STAI-State)|The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety.Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
28918|NCT01623830|Secondary|The Beck Depression Inventory (BDI)|a 21-item measure of cognitive and vegetative symptoms of depression is widely used in a variety of populations, including trauma victims and is sensitive to treatment effects on depression. The possible range for scores is 0-63 with higher scores suggesting more severe symptoms of depression.|post-treatment (9 weeks)|||units on a scale||Standard Deviation|Mean
37004|NCT01493531|Primary|Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.|Proportion of subjects with an sUA level that is < 6.0 mg/dL by Month 6.|6 months|Intent-to-Treat Population||Proportion of Subjects|||Number
28921|NCT01623479|Secondary|Percentage of Subjects Satisfied Wtih Their Eyelashes|Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data||Percentage of Subjects|||Number
28922|NCT01623479|Secondary|Number of Applications of Latisse® Per Week|Number of applications of Latisse® per week as reported by the subjects.|Day 1|Subjects with all study data||Number of Applications||Standard Deviation|Mean
28923|NCT01623479|Primary|Percentage of Subjects Satisfied With Latisse®|Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data||Percentage of Subjects|||Number
28924|NCT01623323|Primary|Adverse Events|Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.|Baseline to 3 months or End of Study|All subject who received at least one dose of study medication||participants|||Number
28925|NCT01623154|Other Pre-specified|Number of Participants Tested Positive/Negative for H. Pylori|"Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement.~UHR values of >10 µg/min were considered positive for H. pylori and UHR values of <10 µg/min were considered negative for H. pylori."|Single Study Visit (1 hour of testing)|95 evaluable subjects for initial diagnosis - each patient received the BreathTek UBT test. Collected breath samples were analyzed on both the UBiT-IR300 and the POC-one.||Participants|||Number
28926|NCT01623154|Primary|Agreement Between POCone and UBiT-IR300.|"The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300.~Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled A B C. Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result.~DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight)."|Baseline, Post Dose (15 min)|Evaluable patients must drink all of the Pranactin-citric solution. Though all three sets of bags were analysed, the first two sets of valid values were used for analysis, regardless of the set designation (A, B or C). The values of individual sets (A, B or C) were not analyzed.||||95% Confidence Interval|Number
28927|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.||percent change||Standard Error|Least Squares Mean
28928|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment.|From Baseline to Week 78|ITT population.||percent change||Standard Error|Least Squares Mean
28929|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
28930|NCT01623115|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
28931|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
28932|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
28933|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
28934|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
28935|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
28936|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
28937|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
28938|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
28939|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|Up to Week 52|ITT population.||percentage of participants|||Number
28940|NCT01623115|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On- Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
28941|NCT01623115|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
28942|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
28943|NCT01623115|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
28944|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
28945|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
28946|NCT01623115|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on-or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
28947|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL­C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
28948|NCT01623115|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
28949|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
28950|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post­baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
28951|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
28952|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post­baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
28953|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
28954|NCT01623115|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
28955|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia of 27 patients analyzed.|12 months|7 patients were lost to follow up||percentage of ostia patent|Participants||Number
28956|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 29 patients analyzed.|6 months|5 patients were lost to follow up||percentage of ostia patent|Participants||Number
28957|NCT01623050|Secondary|Number of Participants With Device-related Adverse Events as a Measure of Safety||3 months|||number of participants|||Number
28958|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 33 patients analyzed.|3 months|One patient was lost to follow up||percentage of ostia patent|Participants||Number
28959|NCT01623050|Primary|Patency of Treated Area||Immediately post procedure|Number of osita treated||percentage of ostia treated|Participants||Number
28960|NCT01622673|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience."|Up to 7 days after the last dose of study drug|All subjects who received any amount of the study drug were included in the safety population||participants|||Number
28961|NCT01622673|Primary|Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir|Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||hr||Standard Deviation|Mean
28962|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
28963|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
28964|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM*hr||95% Confidence Interval|Least Squares Mean
28965|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM*hr||95% Confidence Interval|Least Squares Mean
28966|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®.|12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
28967|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|12 hours postdose|All participants were included for whom at least one pharmacokinetic (PK) parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics||nM||95% Confidence Interval|Least Squares Mean
28968|NCT01622296|Primary|Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment|"Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 (no pain) to 100 (pain as bad as it can be)."|immediately after anesthetic injection|per protocol, in a crossover fashion, each participant received buffered lidocaine at one treatment visit and lidocaine at one treatment visit, in randomly assigned sequence.||units on a scale||Standard Deviation|Mean
28969|NCT01622257|Secondary|Change in Lipid Profile|Change in LDL levels was taken as the indicator of change in lipid profile|Baseline and 3 months|||mg/dl||95% Confidence Interval|Mean
28970|NCT01622257|Secondary|Change in Serum Free Testosterone Level|Change in serum free testosterone levels|Baseline and 3 months|||pg/ml||95% Confidence Interval|Mean
28971|NCT01622257|Secondary|Change in Insulin Resistance|Change in Fasting insulin concentration|Baseline and 3 months|||uIU/ml||95% Confidence Interval|Mean
28972|NCT01622257|Secondary|Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.|"The Number of participants who had evidence of successful ovulation during the 3 months. Ovulation was diagnosed based on ultrasonographic folliculometry and/or luteal serum progesterone assay.Every month, folliculometry was done to count the number of antral follicles (AFC), follow follicular growth, measure dominant follicle diameter and detect occurrence of ovulation. a mid-luteal serum progesterone assay was done to confirm ovulation.~Ultrasound was performed serially till reaching preovulatory follicle(s of around 20 mm in diameter that then rupture to show a collapsed follicle in the same location with internal echoes consistent with its transformation to a corpus luteum. Progesterone assay was done using immulite 2000 apparatus chemiluminescent immunometric assay. Mid-luteal phase progesterone above 6 ng/mL was considered indicative of normal corpus. luteum function."|3 months|||participants|||Number
28973|NCT01622257|Primary|Clinical Pregnancy Rate||9 months|||participants|||Number
28974|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years|PK samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population. Only those participants aged >=6 to <15 years were assessed.||participants|||Number
28975|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years|Pharmacokinetic (PK) samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population: all participants from whom a PK sample was obtained and analyzed. Only those participants aged >=2 to <6 years were assessed.||participants|||Number
28976|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant’s Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant himself/herself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population||participants|||Number
28977|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population||participants|||Number
28978|NCT01622231|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge)|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 4, Week 8, and Week 12/early withdrawal|FAS Population. Only those participants available at the indicated time points were assessed.||participants|||Number
28991|NCT01622231|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||International units (IU)/L||Standard Deviation|Mean
28992|NCT01622231|Secondary|Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||grams/L||Standard Deviation|Mean
40460|NCT01451398|Secondary|Mean 7-point Glucose Week 24 Values|Mean 7-point self-monitored blood glucose at Week 24|Week 24|Full analysis set for patients with data at Week 24||mg/dL||Standard Deviation|Mean
28979|NCT01622231|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
28980|NCT01622231|Secondary|Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Three individual symptoms (eye itching, tearing, and redness) were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
28981|NCT01622231|Secondary|Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
28982|NCT01622231|Secondary|Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Percent change||Standard Deviation|Mean
28983|NCT01622231|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
28993|NCT01622231|Secondary|Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Proportion of RBCs in blood||Standard Deviation|Mean
28994|NCT01622231|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||tera (10^12) cells (TI)/L||Standard Deviation|Mean
28995|NCT01622231|Secondary|Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||giga (10^9) cells (GI)/L||Standard Deviation|Mean
28984|NCT01622231|Secondary|Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Percent change||Standard Deviation|Mean
28985|NCT01622231|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
28986|NCT01622231|Secondary|Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS)|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The BL value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from BL was calculated as the mean score for the entire treatment period minus the score at BL. Only those participants available at the indicated time points were assessed.|Baseline, Day 1 to Day 84|Full Analysis Set (FAS) Population: all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication.||Scores on a scale||Standard Deviation|Mean
28987|NCT01622231|Secondary|Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Percent change||Standard Deviation|Mean
28988|NCT01622231|Secondary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.||Scores on a scale||Standard Deviation|Mean
28989|NCT01622231|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Millimoles (mmol)/L||Standard Deviation|Mean
28990|NCT01622231|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Micromoles (μmol)/L||Standard Deviation|Mean
28996|NCT01622231|Secondary|Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Grams per liter (grams/L)||Standard Deviation|Mean
28997|NCT01622231|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. Basophils, eosinophils, lymphocytes, monocytes, and total neutrophil counts are measured as the percentage of cells in white blood cells.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.||Percentage of cells||Standard Deviation|Mean
28998|NCT01622231|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)|Safety Population: all participants who received at least one dose of medication||participants|||Number
28999|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast|Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days|||mg/dl||Standard Deviation|Mean
29000|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner|Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days|||mg/dl||Standard Deviation|Mean
29001|NCT01621776|Primary|The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.|"Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.~The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona."|averaged over 5 days|Post-Prandial Blood Glucose Values [Within 90 minutes following the completion of participant lunch]||mg/dl||Standard Deviation|Mean
29002|NCT01621672|Primary|Progression Free Survival (PFS)|"Progression was defined as any one or more of the following:~Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or~Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or~If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or~Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or~New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma."|2 years|||percentage of participants|||Number
29003|NCT01621633|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse events, serious adverse events and death were monitored from screening to end of study|From the screening visit until Day 5|Safety set: The safety set includes all participants who received study treatment.||Participants|||Number
29004|NCT01621633|Primary|Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set||ng/mL||Standard Deviation|Mean
29005|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set||ng*hr/mL||Standard Deviation|Mean
29006|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set: The PK analysis set included all subjects with at least one available, valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug, and experienced no protocol deviations with relevant impact on PK data.||ng*hr/mL||Standard Deviation|Mean
29032|NCT01620047|Primary|Comparison of Postoperative Strength (Extension)|To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.|24 hours post-surgery|Per protocol||Nm/kg||Full Range|Median
29860|NCT01606228|Secondary|Daytime Drowsiness at Day 90|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29007|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 WPI or SS assessment.||units on a scale||Standard Deviation|Mean
29008|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BDI-II assessment.||units on a scale||Standard Deviation|Mean
29009|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 SF-36 assessment.||units on a scale||Standard Deviation|Mean
29010|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BPI-S or BPI-W assessment.||units on a scale||Standard Deviation|Mean
29011|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 FIQ assessment.||units on a scale||Standard Deviation|Mean
29012|NCT01621191|Secondary|Clinical Global Impression-Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 CGI-I assessment.||units on a scale||Standard Deviation|Mean
29013|NCT01621191|Secondary|Patient Global Impression-Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 PGI-I assessment.||units on a scale||Standard Deviation|Mean
29014|NCT01621191|Primary|Number of Participants Who Experienced an Adverse Event (AE)|A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 53 weeks|Enrolled participants who received at least 1 dose of study drug.||participants|||Number
29015|NCT01621126|Primary|Neurologic Complication Rate After Latarjet Procedure|Nerve palsy of any nerve(s) in the operative upper extremity.|up to 24 weeks after the procedure|||participants|||Number
29016|NCT01621009|Primary|7-day Point Prevalence Abstinence From Smoking at 6 Months|No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.|6 months|Full intent-to-treat sample||Number of abstinent participants|||Number
29017|NCT01620489|Secondary|Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)|Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.|Week 0, week 26|Safety analysis set included all subjects receiving at least one dose of the trial product. A total of 8 subjects in the safety analysis set did not contribute to the analysis due to missing data.||mL/min/1.73m˄2||Geometric Coefficient of Variation|Geometric Mean
29018|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)|Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||kg/m^2||Standard Deviation|Mean
29033|NCT01619878|Secondary|Time to Gametocyte Clearance (GCT)|Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||hours||Standard Deviation|Mean
29019|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles|SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 46 subjects in the FAS did not contribute to the analysis due to missing data.||mmol/L||Standard Deviation|Mean
29020|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||percentage of patients|||Number
29021|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||percentage of patients|||Number
29022|NCT01620489|Primary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)|Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects that received at least one dose of the study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.||percentage (%)||Standard Deviation|Mean
29023|NCT01620138|Primary|Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma|Magnetic resonance imaging (MRI) of the sella and prolactin will be performed before (baseline) and after 6 months of treatment with cabergoline or pasireotide. Disease progression will be defined as tumor growth > 25%, stable disease as changes < 25% and significant tumor shrinkage as > 25% in tumor volume compared to baseline MRI (baseline to six months).|Baseline to six months|||cmˆ3||Full Range|Median
29024|NCT01620086|Secondary|Depression Level Changes as Measured by the Hamilton Depression Inventory (HAMD).|HAM-D is a multiple choice questionnaire that clinicians administer to rate the severity of a subject's depression. There are 17 questions; each question has between 3-5 possible responses which increase in severity (range 0 to 52). The clinician chooses the correct response by interviewing the subject and by observing the symptoms. A score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.||units on a scale||Standard Deviation|Mean
29025|NCT01620086|Secondary|Overall Change in the Percent Habituation of the P50 Evoked Response Potential at 250 Inter Stimulus Interval (ISI) Between the Control and Active Treatments (1 and 10 Hz).|Percent habituation refers to change in the amplitude of the P50 evoked response potential following a 250 ms inter stimulus interval. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Three patients had missing data for the control site - baseline condition and the active 1 Hz treatment site -baseline conditions. One patient had missing data for the active 10 Hz treatment site - baseline.||percent of change in wave amplitude||Standard Deviation|Mean
29026|NCT01620086|Primary|Changes in Auditory Hallucinations Questionnaire (AHQ).|The Auditory Hallucinations Questionnaire (AHQ) will be used to determine the patient's perceptions of change in auditory hallucinations(s). Normal controls do not fill out this measure because they do not have auditory hallucinations. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. The range of scores is 0-70, higher scores mean more symptoms.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.||units on a scale||Standard Deviation|Mean
29027|NCT01620060|Secondary|Number of Participants With Serious Adverse Events and Non-serious Adverse Events|Serious adverse event and adverse events data will be listed and summarized as per MedDRA V15.0|11 Days|||participants|||Number
29028|NCT01620060|Primary|Lurasidone Peak Serum Concentration (Cmax)|Cmax will be listed and summarized in tabular format|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours|||ng/mL||Standard Deviation|Mean
29029|NCT01620060|Primary|Lurasidone Primary Pharmacokinetic Parameters|Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours|"Participants for PK analysis included all subjects who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK timepoint after start of dosing for at least 1 PK analyte.~For some PK parameters, some subjects didn't have PK data."||ng.h/mL||Standard Deviation|Mean
29030|NCT01620047|Secondary|Serum Fentanyl Levels|To identify a difference in serum fentanyl levels among the groups.|24 hours post-surgery||||||
29031|NCT01620047|Secondary|VAS Scores and Postoperative Supplemental Morphine Consumption|"Secondary Objective~To determine the amount of required supplemental analgesia during the postoperative period.~To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 – 10 centimeter line."|24 hours post-surgery||||||
31271|NCT01585324|Secondary|Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
29034|NCT01619878|Secondary|Time to Fever Clearance (FCT)|Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||hours||Standard Deviation|Mean
29035|NCT01619878|Secondary|Time to Parasite Clearance (PCT)|Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||hours||Standard Deviation|Mean
29036|NCT01619878|Secondary|Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline|Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.|72 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||participants|||Number
29037|NCT01619878|Secondary|Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline|Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.|48 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||participants|||Number
29038|NCT01619878|Secondary|Percent Change of Parasite Count From Baseline at 24 Hours|Percent change of parasite count from baseline at 24 hours|baseline, 24 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||Percent Change||Standard Deviation|Mean
29039|NCT01619878|Secondary|Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42|Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.|Day 3, 7, 14, 28 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||participants|||Number
29040|NCT01619878|Secondary|Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|Day 14 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||Number of participants|||Number
29041|NCT01619878|Primary|Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|28 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.||number of participants|||Number
29042|NCT01619800|Primary|Changed in Stress Test at 6 Months as Compared to Baseline|An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.|baseline and 6 months||||||
29043|NCT01619787|Primary|Change in Energy Purchased as a Result of Subsidies|Change in total calories as a result of subsidies of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.||Total Calories Purchased||Standard Error|Least Squares Mean
29044|NCT01619787|Primary|Change in Energy Purchased as a Result of Taxes.|Change in total calories as a result of taxes of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.||Total Calories Purchased||Standard Error|Least Squares Mean
29045|NCT01619774|Secondary|Progression-Free Survival (PFS)|Duration of response defined for subjects with a confirmed complete response (CR) or partial response (PR), as time from the first documented evidence of a CR or PR until the first documented disease progression or death due to any cause. Progression free survival (PFS) estimated and summarized using the method of Kaplan and Meier.|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response therefore not included PFS analysis.||weeks||95% Confidence Interval|Median
29046|NCT01619774|Primary|Number of Participants by Response|Clinical responses evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks). Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study.|Evaluation every 8 weeks (2 cycles) up to 12 months|||participants|||Number
29047|NCT01619774|Primary|Overall Response Rate (ORR)|"Overall response rate defined as percentage of subjects with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Clinical responses will be evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks).~Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study."|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response.||Percentage of Participants|||Number
40461|NCT01451398|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point self-monitored glucose at baseline|Baseline|Full analysis set||mg/dL||Standard Deviation|Mean
29048|NCT01619579|Primary|Symptom Severity (SS) Score After 4 Weeks Treatment|"Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome).~The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale:~0 = no problem~slight or mild~moderate~severe: continuous, life-disturbing"|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.||units on a scale||Full Range|Mean
29049|NCT01619579|Primary|Tender Point Count (TPC) After 4 Weeks Treatment|"Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites.~Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points."|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.||units on a scale||Full Range|Mean
29050|NCT01619579|Primary|Widespread Pain Index (WPI) Score After 4 Weeks Treatment|Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.||units on a scale||Full Range|Mean
29051|NCT01619059|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values||Percent of participants||95% Confidence Interval|Number
29052|NCT01619059|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24||mg/dL||Standard Error|Mean
29053|NCT01619059|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24||mg/dL||Standard Error|Mean
29054|NCT01619059|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24||Percent of glycosylated haemoglobin||Standard Error|Mean
29055|NCT01618968|Primary|Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration (Cmax) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng/mL/mg||Standard Deviation|Mean
29056|NCT01618968|Primary|Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng*hr/mL/mg||Standard Deviation|Mean
29057|NCT01618968|Primary|Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.||ng*hr/mL/mg||Standard Deviation|Mean
29058|NCT01618955|Secondary|Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.~Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection."|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For continuous data, summary statistics (N, mean, standard deviation, median, minimum, and maximum) were provided.||mm||Standard Deviation|Mean
29059|NCT01618955|Secondary|Safety of Vibex MTX Device|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device~Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following:~Erythema - 0 = None~Erythema - 1 = Very slight, barely perceptible~Erythema - 2 = Obvious, but well defined~Erythema - 3 = Moderate to severe~Erythema - 4 = Severe"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, counts and percentages are presented.||Percentage of Participants|||Number
29079|NCT01618708|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks|WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From baseline to Week 26|ITT population.||units on a scale||Standard Error|Least Squares Mean
29060|NCT01618955|Secondary|Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device~Ease of use Questionnaire was completed by patients immediately after self-injection~Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.||Percentage of Participants|||Number
29061|NCT01618955|Primary|Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.~The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient’s performance of essential self-injection steps, including the following:~SC self-injection was administered by the patient~SC self-injection was intentional~self-injection was administered in an appropriate location on the abdomen~patient removed cap marked “1~patient removed cap marked “2~patient held device at injection site for 3 seconds~patient confirmed that the window was obstructed"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.||Percentage of Participants|||Number
29062|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.01cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
29063|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
29064|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.01 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
29065|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
29066|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
29067|NCT01618942|Secondary|Measuring Values of Skinfold Thickness||10 minutes after the procedure|||millimeters||Standard Deviation|Mean
29068|NCT01618942|Secondary|Time of Each Test Procedure||10 minutes after the procedure|||seconds||Standard Deviation|Mean
29069|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure|||kg/cm2||Standard Deviation|Mean
29070|NCT01618864|Secondary|Reduction in Rosacea by the Study Investigator Using a Validated Scale|Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.|4, 8 weeks|Not all subjects had rosacea. 11 subjects evaluated at baseline and 4 weeks; 9 subjects evaluated at 8 weeks, since 2 subjects lost to follow-up.||percentage of participants|||Number
29071|NCT01618864|Secondary|Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale|Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.|4, 8 weeks|||percentage of participants|||Number
29072|NCT01618864|Primary|Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)|Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.|4, 8 weeks|||percentage of participants|||Number
29073|NCT01618838|Secondary|Progression-free Survival|Progression-free survival will be defined as the time in months from study entry until progression or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date.|7 Years||||||
29074|NCT01618838|Secondary|Proportion of Patients With Rectal Bleeding.||7 years||||||
29075|NCT01618838|Primary|Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).|"Telangiectasia is the primary outcome since it is a measure of tissue fribrosis (primary source of proctitis) and is a well-defined and measurable outcome.~No patients had outcome before the trial was terminated."|7 years||||||
29076|NCT01618708|Secondary|Percentage of WOMAC A1 Responder Over 26 Weeks|WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.|From Baseline to Week 26|ITT population.||Percentage of participants|||Number
29077|NCT01618708|Secondary|Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks|PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.|From baseline to Week 26|ITT population.||units on a scale||Standard Error|Least Squares Mean
29078|NCT01618708|Secondary|Change From Baseline in WOMAC A Score Over 26 Weeks|WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From Baseline to Week 26|ITT population.||units on a scale||Standard Error|Least Squares Mean
29110|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.||percentage (%) of subjects|||Number
29080|NCT01618669|Secondary|Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson|"An adverse event is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes:~Results in death,~Is life threatening,~Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions,~Results in congenital anomaly, or birth defect,~Requires inpatient hospitalization or leads to prolongation of hospitalization~Other medically important events.~Relationship to study drug was assessed by the investigator."|Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)|Safety Analysis Set.||participants|||Number
29081|NCT01618669|Secondary|Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity|The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported.|Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)|Full Analysis Set||percentage of segments|||Number
29082|NCT01618669|Secondary|Percentage of Scans With Subdiaphragmatic Interference|Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set||percentage of stress MPI scans|||Number
29083|NCT01618669|Secondary|Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans|Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference).|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full analysis set participants who have planar images available for each scan||ratio||Standard Deviation|Mean
29084|NCT01618669|Secondary|Overall Assessment of Image Quality|The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan.|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||participants|||Number
29085|NCT01618669|Secondary|Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan|Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category.|Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)|Full Analysis Set||participants|||Number
29086|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/ uptake~2: moderately reduced contrast/uptake~3: severely reduced contrast/uptake~4: absent contrast/uptake.~SSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS – SRS).~The mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||participants|||Number
29087|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||proportion of participants|||Number
29088|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI.|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set||proportion of participants||95% Confidence Interval|Number
29089|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set||proportion of participants||95% Confidence Interval|Number
29111|NCT01618214|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomisation measurements were available. Six subjects did not contribute to FAS due to lack of post-randomisation measurements.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
29090|NCT01618669|Secondary|Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events|"A clinically significant cardiac event is defined as:~Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration:~ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter),~ST-T depression (> 2 mm),~ST-T elevation (≥1 mm),~Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block)~sinus arrest > 3 seconds in duration~Or~a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction~Or~a TEAE preferred term of angina unstable within 24 hours of regadenoson administration."|Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson|Safety analysis set (all randomized participants who received at least 1 dose of regadenoson study drug)||percentage of participants|||Number
29091|NCT01618669|Primary|Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans|"SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect.~The number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia.~Each reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits.~Majority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant."|Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)|Full Analysis Set||proportion of participants||95% Confidence Interval|Number
29092|NCT01618422|Primary|Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group.|"Cure (Completed for 8 months or more of therapy and culture converted in the last month of treatment, and on at least one previous occasion; for multidrug resistant TB (MDR-TB) switched to definitive second line therapy per protocol in the DOTS-plus group, sustained culture conversion for at least 6 months after initiation of second line therapy and no evidence of culture reversion up to the scheduled follow-up point); Treatment failure: not culture converted at 5 months or later; Defaulted: having interrupted treatment for 2 consecutive months or more; Transfer out: having been transferred to another recording and reporting unit and for whom the treatment outcome is not known; Death: a patient who died for any reason during the course of treatment Diagnosis revised: diagnosis revised to non-tuberculous mycobacterial infection or colonisation.~Withdrawal: physician-initiated withdrawal for adverse effects, protocol violation or patient’s decision to withdraw."|18-month|||participants|||Number
29093|NCT01618266|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 24|All enrolled patients||Percentage of Patients|||Number
29094|NCT01618266|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 6, Month 4, Month 12, Month 18, Month 24|All enrolled patients||Letters||Standard Deviation|Mean
29095|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.|Baseline, Month 6|All enrolled patients receiving Ozurdex® and then other RVO treatments||Letters||Standard Deviation|Mean
29096|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.|Baseline, Month 6|All enrolled patients only treated with Ozurdex||Letters||Standard Deviation|Mean
29097|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset ≥3 months||Letters||Standard Deviation|Mean
29169|NCT01617603|Secondary|Cholesterol Profile After 12 Weeks of Product Intake|Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake|84th day of product intake||||||
29098|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset <3 months||Letters||Standard Deviation|Mean
29099|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients previously naïve to Ozurdex® treatment||Letters||Standard Deviation|Mean
29100|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.|Baseline, Month 6|All enrolled patients previously treated with Ozurdex®||Letters||Standard Deviation|Mean
29101|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients who were treatment naïve||Letters||Standard Deviation|Mean
29102|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.|Baseline, Month 6|All enrolled patients with CRVO||Letters||Standard Deviation|Mean
29103|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.|Baseline, Month 6|All enrolled patients with BRVO||Letters||Standard Deviation|Mean
29104|NCT01618266|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Month 6|All enrolled patients||Letters||Standard Deviation|Mean
29105|NCT01618240|Secondary|Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration||Within 3 month follow-up|||participants|||Number
29106|NCT01618240|Primary|Muscle Strength|We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.|Within 24 hours of fiberoptic endoscopic evaluation of swallow|||participants|||Number
29107|NCT01618214|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.|Week 0 to week 20 (inclusive).|Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.||events per patient per year|||Number
29108|NCT01618214|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose)||Week 0, week 20|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. Seven subjects did not contribute to FAS due to lack of post-randomization measurements.||mmol/L||Standard Deviation|Mean
29109|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.||percentage (%) of subjects|||Number
29170|NCT01617603|Secondary|Endothelial Function After 12 Weeks of Product Intake|Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)|84th day of product intake||||||
29112|NCT01618162|Secondary|Number of Adverse Events (AEs)|An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.|After 26 weeks of treatment|Safety analysis set.||event rate per 100 PYE|||Number
29113|NCT01618162|Secondary|Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes|"An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.~Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.~Minor hypoglycaemic episodes were defined as:~An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.~Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).~Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE)."|After 26 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of the trial product.||event rate per 100 PYE|||Number
29114|NCT01618162|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight at week 26.|Week 0, week 26|Full analysis set.||kilogram||Standard Deviation|Mean
29115|NCT01618162|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at week 26.|Week 0, week 26|Full analysis set.||mmol/L||Standard Deviation|Mean
29116|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Percentage of subjects having HbA1c below 6.5% at week 26|Week 26|Full analysis set.||percentage of subjects|||Number
29117|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)|Percentage of subjects having HbA1c below 7% at week 26.|Week 26|Full analysis set.||percentage of subjects|||Number
29118|NCT01618162|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change in HbA1c from baseline to 26 weeks.|Week 0, Week 26|Full analysis set.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
29119|NCT01618019|Secondary|CTX Concentration|serum C-terminal telopeptide of type 1 collagen concentration as nmol/L|16 week|Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week||nmol/L||Standard Error|Mean
29120|NCT01618019|Secondary|BSAP Concentration|serum bone specific alkaline phosphatase concentration as U/L|16 week|Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week||U/L||Standard Deviation|Mean
29121|NCT01618019|Secondary|Osteocalcin Concentration|serum Osteocalcin concentration as nmol/L|16 week|Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week||nmol/L||Standard Deviation|Mean
29122|NCT01618019|Secondary|Pain Scale|Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week.||units on a scale||Standard Deviation|Mean
29123|NCT01618019|Secondary|Patient’s Global Assessment|Patient’s global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Patient’s global assessment at 16 week.||units on a scale||Standard Deviation|Mean
29124|NCT01618019|Secondary|Physician’s Global Assessment|"Physician’s global assessment is ranged from 0 to 10 by the assessing physician.~(0= no pain; 10= very severe pain)"|16 week|Per-protocol analysis (except for drop out patients) Measurement of Physician’s global assessment at 16 weeks.||units on a scale||Standard Deviation|Mean
29125|NCT01618019|Secondary|Duration of Morning Stiffness|Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.|16 week|Per-protocol analysis (except for drop out patients) Measurement of Morning stiffness assessment at 16 weeks, except for 16 in N-3 PUFA and 16 in placebo||minutes||Standard Deviation|Mean
29126|NCT01618019|Primary|Dose of NSAID|Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day|16 week|Per-protocol analysis (except for drop out patients) Measurement of NSAID requirements at 16 weeks, except for 10 in N-3 PUFA and 6 in placebo.||mg||Standard Deviation|Mean
29127|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for AUClast|To evaluate the PK of LCL161 when given in combination with paclitaxel|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.||ng*hr/mL||Full Range|Median
29128|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Tmax|To evaluate the PK of LCL161 when given in combination with paclitaxel. The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.||h||Full Range|Median
29129|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Cmax|To evaluate the PK of LCL161 when given in combination with paclitaxel.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.||ng/mL||Full Range|Median
29130|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS2|To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined. Cycle = 28 days; each patient had either C1D2 or C1D9|Baseline, Post-baeline at Cycle 1, Day 2 or Cycle 1, Day 9|The Efficacy Analysis Set 2 (EAS2) was the same as EAS1 except that the threshold for classifying a patient into the positive gene group was 0.7716. All the EAS2 set participants were considered for the analysis (N). Only participants (n) who had baseline and post baseline values for the given time point were analyzed for that time point.||% of positive tumor cells||Standard Deviation|Mean
36468|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ambulatory blood pressure monitoring (ABPM) record||mmHg||Standard Deviation|Mean
29131|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS1|"To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined.~Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661 (positive: score ≥ 0.6661; negative: score <0.6661); cycle = 28 days; each patient had either C1D2 or C1D9"|Baseline, Post-baeline at Cycle 1, Day 2 (C1D2) or Cycle 1, Day 9 (C1D9)|Efficacy Analysis Set 1 (EAS1) is patients (pts) who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with valid gene expression signature score. All pts were considered for analysis (N). Only pts (n) with baseline & post baseline values for the given time point were analyzed for that time point.||% of positive tumor cells||Standard Deviation|Mean
29132|NCT01617668|Secondary|Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. Rates of breast conserving surgery and mastectomy also contributed to the overall assessment of disease response and were summarized by treatment arm within each gene expression signature status. For this analysis, patients with multicentric breast cancer were excluded, as all patients in this group were expected to be treated with mastectomy.|16 weeks|EAS1 - patients receiving at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature (GES) score. GES status is derived based on continuous GES score using cut-off 0.6661(pos: score ≥ 0.6661; neg: score <0.6661). Patients with multicentric breast cancer were excluded.||Percentage of participants|||Number
29133|NCT01617668|Secondary|pCR Rate in Breast, Regional Nodes and Axilla|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. The pCR in breast, regional nodes, and axilla were determined based on the America Joint Committee on Cancer Staging [AJCC] stages T1c, T2, N0-N2, M0) were (AJCC) pathologic staging recorded on the eCRF: a patient was considered to be a responder in breast, regional nodes, and axilla if the pathological complete response was reported for breast and if the regional lymph nodes staging was pN0 (including i-, mol-, mol+).The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Percentage of participants||95% Confidence Interval|Median
29134|NCT01617668|Secondary|pCR Rate in Breast After 12 Weeks of Therapy With Single Agent LCL161 and LCL161 + Paclitaxel, Regardless of Gene Signature Status|To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer regardless of tumor gene expression signature status. This comparison is between the 2 study treatments, regardless of gene signature status. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Percentage of participants||95% Confidence Interval|Median
29135|NCT01617668|Secondary|Posterior Distribution of Difference in pCR Rates After Treatment With Paclitaxel Only Between Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with paclitaxel only. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Difference in percentage of participants||95% Confidence Interval|Median
29136|NCT01617668|Secondary|Posterior Distribution of Difference of pCR Rates After Treatment With LCL161 + Paclitaxel Between Patients With Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with LCL161 and paclitaxel. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)||Difference in percentage of participants||95% Confidence Interval|Median
29137|NCT01617668|Primary|Difference in pCR Rates Between Treatment Arms|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on the posterior distribution of the difference in pCR rates between the experimental and control arms of the study, within each gene expression signature group.The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|FAS are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or 1 full or partial dose of paclitaxel alone. These values are medians of posterior distribution of difference of pCR rate between treatment arms based on a Bayesian model. 95% Confidence interval is actually 95% credible interval.||Difference in percentage of participants||95% Confidence Interval|Median
36469|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
29138|NCT01617668|Primary|Number of Participants With Pathological Complete Response (pCR) in Breast After 12 Weeks of Therapy|To assess the number of patients who experienced a pathological response in breast.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.||Participants|||Number
29139|NCT01617668|Primary|Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.||Percentage of Participants||95% Confidence Interval|Median
29140|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 i.e. up to 21 days after last injection.|From Baseline to Week 78|mITT population.||percent change||Standard Error|Least Squares Mean
29141|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.||percent change||Standard Error|Least Squares Mean
29142|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
29143|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
29144|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|Up to Week 52|ITT population.||percentage of participants|||Number
29145|NCT01617655|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.||percent change||Standard Error|Least Squares Mean
29146|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
29147|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
29148|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
29149|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post­baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on-or off-treatment (Apo A-1 ITT population).||percent change||Standard Error|Least Squares Mean
29150|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
29151|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on-or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
29152|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
29153|NCT01617655|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.||percentage of participants|||Number
29861|NCT01606228|Secondary|Daytime Drowsiness at Baseline|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29154|NCT01617655|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
29155|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
29156|NCT01617655|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
29157|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
29158|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
29159|NCT01617655|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (total-C ITT population).||percent change||Standard Error|Least Squares Mean
29160|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
29161|NCT01617655|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
29162|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
29163|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
29164|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
29165|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
29166|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
29167|NCT01617655|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post­baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off- treatment.||percent change||Standard Error|Least Squares Mean
29168|NCT01617603|Secondary|Oxidative Stress After 12 Weeks of Product Intake|Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF) at the 84th day of product intake|84th day of product intake||||||
29171|NCT01617603|Primary|Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake|HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index > 2.4|84th day of product intake|||HOMA index||Inter-Quartile Range|Mean
29172|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:~mean ADAScog: a decrease in total score units = improvement, min=0 max= mean PAL (memory): an increase in score = improvement, mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and final visit (14 wks)|||units on a scale||Standard Error|Mean
29173|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:~mean ADAScog: a decrease in total score units = improvement, min=0 max=31 mean PAL (memory): an increase in score = improvement, min= 0 max=12 mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and 2wk and 4 wk after Rx;|||units on a scale||Standard Error|Mean
29174|NCT01617434|Secondary|Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period|Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.||Events/100 years of patient exposure|||Number
29175|NCT01617434|Secondary|Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period|A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.||Events/100 years of patient exposure|||Number
29176|NCT01617434|Secondary|Number of Adverse Events (AEs) During The Randomised Treatment Period|An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial product.||Events/1000 years of patient exposure|||Number
29177|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)|Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||percentage of subjects|||Number
29178|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)|Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||percentage of subjects|||Number
29179|NCT01617434|Secondary|Change in Body Weight From Baseline to Week 26|The estimated mean change in body weight after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 216 subjects in the placebo arm contributed to the statistical analysis.||kg||Standard Deviation|Mean
29180|NCT01617434|Secondary|Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26|The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 191 subjects in the liraglutide arm and 196 subjects in the placebo arm contributed to the statistical analysis.||mmol/L||Standard Deviation|Mean
29181|NCT01617434|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 213 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||mmol/L||Standard Deviation|Mean
29182|NCT01617434|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26|The estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
29183|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29184|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29185|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29186|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29187|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29188|NCT01617187|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29189|NCT01617187|Secondary|Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29190|NCT01617187|Secondary|Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29238|NCT01615731|Secondary|Overall Patient Experience|Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.|Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge|||units on a scale||Inter-Quartile Range|Median
29191|NCT01617187|Secondary|Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||percentage of participants|||Number
29192|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35|CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29193|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35|A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||percentage of participants|||Number
29194|NCT01617187|Secondary|Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29195|NCT01617187|Secondary|Change From Baseline in Body Weight at Day 42|Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.|Baseline and Day 42|All randomized participants who received ≥1 dose of study drug||kg||Standard Error|Least Squares Mean
29196|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42|Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||percentage of participants|||Number
29197|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Day 42|Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29198|NCT01617187|Primary|Change From Baseline in PANSS Total Score at Day 42|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score||score on a scale||Standard Error|Least Squares Mean
29199|NCT01617070|Primary|Urine Dopamine at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.||ug/gCreatinine||Standard Deviation|Mean
29200|NCT01617070|Primary|Urine 6-sulfatoxymelatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.||ng/mg Creatinine||Standard Deviation|Mean
29201|NCT01617070|Primary|Serum Melatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.||pg/ml||Standard Deviation|Mean
29202|NCT01617005|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline up to Week 24|As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable.|||||
29203|NCT01617005|Secondary|Number of Participants Who Discontinued Treatment Due to Lack of Efficacy||Baseline up to Week 24|All participants enrolled in the study.||participants|||Number
29690|NCT01609062|Secondary|Normalized Urine Keratan Sulfate (uKS)|"Urinary KS was measured by a quantitative method and normalized using the sample urinary creatinine measurement.~Percent change from baseline to Week 12, 24, and 52 in normalized urine keratan sulfate (ug/mg)."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
29204|NCT01617005|Secondary|Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria|EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.|Baseline, Week 24|All participants enrolled in the study.||participants|||Number
29205|NCT01617005|Primary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.|Baseline up to Week 24|All participants enrolled in the study.||participants|||Number
29206|NCT01616771|Secondary|The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL|"Glottis view was scored using C&L grade by GVL selected by weight and smaller sized GVL, and compared each other.~Score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1day of surgery|Four of 23 patients could not be evaluated by smaller sized GVL because there was no smaller blade than their GVL selected by weight.||units on a scale||95% Confidence Interval|Median
29207|NCT01616771|Primary|The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.|"Glottis view was scored using C&L grade by Macintosh laryngoscope and GVL selected by weight, and compared each other.~We used modified C&L grade: grade 1, all or most of the glottic aperture was visible; grade 2a, posterior cords and cartilage visible; grade 2b, only posterior cartilage visible; grade 3a, epiglottis visible and can be lifted; grade 3b, epiglottis adherent to the posterior pharynx; and grade 4, the epiglottis could not be visualized.~For the statistical analysis, the modified C&L grade was converted to an ordinal scale; grade 1 to 1, grade 2a to 2, grade 2b to 3, grade 3a to 4, grade 3b to 5, and grade 4 to 6. Therefore, score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1 day of surgery|||units on a scale||95% Confidence Interval|Median
29208|NCT01616576|Primary|Device-related Adverse Events|Device-related adverse events will be assessed to determine whether they impact current device safety performance.|2 weeks|||Events|||Number
29209|NCT01616576|Primary|Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.|Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.|2 weeks|||Percent Correct||Standard Deviation|Mean
29210|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Day 0 to Month 11|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.||Subject|||Number
29211|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.||Subject|||Number
29212|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.||Subject|||Number
29221|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine||06/2016||||
29213|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.||Subject|||Number
29214|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subject|||Number
29215|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
29216|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
29217|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
29218|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine||06/2016||||
29219|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||EL.U/mL||95% Confidence Interval|Geometric Mean
29220|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 10 and Month 11, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine||06/2016||||
40462|NCT01451398|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/100 Subject-Month|||Number
29222|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study.|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine||06/2016||||
29223|NCT01616459|Primary|Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study.|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3). Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) was not performed due to unavailability of a specific qualified assay.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.||µg/mL||95% Confidence Interval|Geometric Mean
29224|NCT01616173|Secondary|Pain Scores|Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).|2 weeks|||units on a scale||Inter-Quartile Range|Median
29225|NCT01616173|Secondary|Opioid Consumption|Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.|2 weeks|||mg/day||Inter-Quartile Range|Median
29226|NCT01616173|Primary|Quality of Recovery|QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.|2 weeks|||units on a scale||Inter-Quartile Range|Median
29227|NCT01615939|Secondary|Pain Control|Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable|72 hrs|||units on a scale||Inter-Quartile Range|Median
29228|NCT01615939|Secondary|Participant Satisfaction With Anesthesia|Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied|24 hours|||units on a scale||Inter-Quartile Range|Median
29229|NCT01615939|Primary|Temporary Neurologic Symptoms Between Groups|Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion|1 month|||percentage of total participants|||Number
29230|NCT01615822|Secondary|MQ Cmax|Peak Plasma Concentration (Cmax) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
29231|NCT01615822|Secondary|MQ AUC0-t|Area under the plasma concentration versus time curve (AUC) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
29232|NCT01615822|Secondary|OZ439 Cmax|Peak Plasma Concentration (Cmax) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
29233|NCT01615822|Primary|OZ439 AUC0-t|Area under the plasma concentration versus time curve (AUC) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
29234|NCT01615809|Secondary|Invasive Pulmonary Aspergillosis (IPA)-Related Mortality During Primary Prophylaxis With Abelcet® in Paediatric Patients With (AL) Undergoing Intensive Chemotherapy.|Percentage of deaths related to API during the prophylactic treatment period with Abelcet® in paediatric patients with (AL) undergoing intensive chemotherapy|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks|||percentage of deaths||95% Confidence Interval|Number
29235|NCT01615809|Secondary|Efficacy of Primary Prophylaxis With Nebulized Abelcet® on the Incidence of Invasive Pulmonary Aspergillosis (IPA) in Paediatric Patients With Acute Leukaemia (AL) Undergoing Intensive Chemotherapy|The Incidence of IPA during the Abelcet® prophylactic treatment period was assessed by the relation between the number of patients with IPA and the number of patients on prophylaxis.|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks|At baseline, none of the 32 pediatric patients with acute leukemia included in the clinical trial had API. During the trial period there were 3 patients who developed API||participants|||Number
29236|NCT01615809|Primary|Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability|is assessed by the proportion of patients who discontinue prophylactic treatment with Abelcet® due to an adverse event that is related or not to the study drug or for intolerability to it. The last week of treatment will have a different calendar for each participant, depending on the number of cicles needed by each patient (it has been anticipated up to 5 cicles of 2-6 weeks each).|at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks|pediatric patients||participants|||Number
29237|NCT01615731|Secondary|Adverse Events|uterine perforation, uterine injury, etc.|Intraoperatively and 2 weeks post operatively|||participants|||Number
29239|NCT01615731|Secondary|Pain Perceived by Patient|Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.|Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)|||units on a scale||Inter-Quartile Range|Median
29240|NCT01615731|Secondary|Ease of Procedure by Blinded Surgeon|Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.|Measured Immediately after procedure|||units on a scale||Inter-Quartile Range|Median
29241|NCT01615731|Secondary|Adverse Events (EBL)|One adverse event: Estimated Blood Loss|Intraoperatively|||mL||Standard Deviation|Mean
29242|NCT01615731|Secondary|Maximum Cervical Dilation|Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.|Measured intra-operatively|"Data missing for one subject in Mifepristone plus one set of dilators arm."||participants|||Number
29243|NCT01615731|Secondary|Total Procedure Time|All time required by patient (time in clinic for cervical preparation procedures)|Measured at clinic visits and on OR day, over a 3 day period||||||
29244|NCT01615731|Primary|Procedure Time|Measured as time from speculum insertion to removal|Intraoperative Time|||minutes||Standard Deviation|Mean
29245|NCT01615328|Secondary|VAS of Neck Pain(Postoperative 6 Months)|"Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).~Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled “no pain (zero point)” at the far left and “greatest pain (ten point)” at the far right."|at 6 months after surgery (ACDF)|||scores on a scale||Standard Deviation|Mean
29246|NCT01615328|Secondary|VAS of Radiating Pain (Postoperative 6 Months)|"Evaluation of radiating pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).~Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled “no pain (zero point)” at the far left and “greatest pain (ten point)” at the far right."|at 6 months after surgery (ACDF)|||scores on a scale||Standard Deviation|Mean
29247|NCT01615328|Primary|Bone Fusion With CT(Postoperative 6 Months)|Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).|6 months after surgery(ACDF)|||participants|||Number
29248|NCT01615263|Secondary|Use of Suction to Facilitate Lung Collapse||Up to 5 minutes after surgery|||participants|||Number
29249|NCT01615263|Secondary|Opinion on the Device|20 minutes after pleural opening, the thoracic surgeon will give his opinion on the lung isolation device that was used on his patient (double lumen tube or bronchial blocker).|20 minutes after pleural opening|||percentage of right guess/opinion|||Number
29250|NCT01615263|Secondary|Quality of Lung Collapse|"Assessment of lung collapse by the thoracic surgeon at 0, 5, 10 and 20 minutes after pleural opening.Visual analog scale of the quality of lung collapse will be assessed as the following:~No lung collapse~Partial lung collapse, not satisfactory~Partial lung collapse, satisfactory~Complete lung collapse"|From pleural opening to 20 minutes after|||percentage of patients|||Number
29251|NCT01615263|Primary|Time to Obtain Complete Lung Collapse|For patients intubated with double lumen tube (DLT), clamping of the ipsilateral lumen without continuous positive airway pressure (CPAP) on the isolated lung will be done to allow lung collapse. The timer will be started at this moment and stopped 20 minutes after pleural opening. For patients of the bronchial blocker (BB) group, the first apnea period will of 30 seconds, keeping a pulse oximetry (SpO2) always over 97%, and under direct visualization with the FOB. Afterward, the cuff will be reflated and the timer will be started at this moment and stopped 20 minutes after pleural opening. For both groups, time of total lung collapse will be measured.|From the beginning of one lung ventilation to 20 minutes after pleural opening|||minutes||Standard Deviation|Mean
29252|NCT01615198|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|14 weeks|Participants from the safety analysis set were analyzed. The safety analysis set included all randomized participants who received study medication and had post baseline assessments.||Participants|||Number
29253|NCT01615198|Secondary|Number of Participants Achieving Successful Response in msSBP and msDBP|Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.|4 weeks,10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||Participants|||Number
29254|NCT01615198|Secondary|Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||Participants|||Number
29255|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.||mmHg||Standard Deviation|Mean
29862|NCT01606228|Secondary|Quality of Sleep at Day 90|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29256|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.||mmHg||Standard Deviation|Mean
29257|NCT01615198|Secondary|Change From Baseline in Daytime and Nighttime maSBP/maDBP|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.||mmHg||Standard Error|Least Squares Mean
29258|NCT01615198|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.|Baseline, 4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at the given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
29259|NCT01615198|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Participants from the full analysis set (FAS), who had both baseline and week 10 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
29260|NCT01615198|Secondary|Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.||mmHg||Standard Error|Least Squares Mean
29261|NCT01615198|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.|Baseline, 4 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
29262|NCT01615198|Secondary|Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.||mmHg||Standard Error|Least Squares Mean
29263|NCT01615198|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Only participants, who had both baseline and week 10 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
29264|NCT01614886|Secondary|The Percentage of Treatment Retention.|Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings – 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline. Patients were analyzed according to the treatment group they were assigned to at randomization.||Percentage of Participants|||Number
29265|NCT01614886|Secondary|Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With “Improvement”: a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly|The J-CGIC is simple 7 grade investigator’s impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3.|4, 8, 12,16, 20 and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.||Participants|||Number
29266|NCT01614886|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE was used to measure severity of Alzheimer’s disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.||Units on a scale||Standard Deviation|Mean
37509|NCT01484912|Secondary|Change in Rate-pressure Product|Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.|baseline (visit 2) to week 6 (visit 5)||||||
29267|NCT01614886|Secondary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline, 8,16, and 24 weeks|Full analysis set (FAS): includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.||Units on a scale||Standard Deviation|Mean
29268|NCT01614886|Primary|Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation|The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline.||Percentage of participants|||Number
29269|NCT01614795|Secondary|Observed Incidence in Each Reporting Period by Type and Grade of Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||25 cycles (700 days)||||||
29270|NCT01614795|Secondary|Percentage of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment||Baseline||||||
29271|NCT01614795|Secondary|Percentage of Patients Expressing IGF-1R, Insulin Receptor, ERK, RON, and mTOR||Up to 5 years||||||
29272|NCT01614795|Secondary|Progression-free Survival|Will be calculated according to the method of Gray accounting for censoring and the competing events.|The date of enrollment until the end PFI date, calculated as the date of disease progression, date of death, date of removal of all tumor by surgery or last patient contact, whichever occurs first, assessed up to 5 years||||||
29273|NCT01614795|Primary|Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST).|We will consider the combination of sufficient activity if the true response rate is 35% or greater. .|6 cycles (168 days)|One (1) of the patients in Group 1 and one (1) of the patients in Group 4 were considered inevaluable for response assessment. One (1) of the patients in Group 2 was ineligible.||participants|||Number
29274|NCT01614769|Primary|Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery|The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.||mg/dL||90% Confidence Interval|Least Squares Mean
29275|NCT01614769|Primary|Rate of Recovery From Hypoglycemia to Euglycemia|The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.||mg/dL/minute||90% Confidence Interval|Least Squares Mean
29276|NCT01614769|Primary|Recovery Time From Hypoglycemia to Euglycemia|Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements >= 70 mg/dL, is called the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.||Minutes||90% Confidence Interval|Least Squares Mean
29277|NCT01614613|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects responded to statements about meter accuracy and diabetes management. Subject responses: 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'or No Response. □1ACCURACY HELPS 1A-with my ability to talk with my HCP. 1B-my satisfaction with my self monitoring of diabetes. 1C-with my ability to manage my diabetes. 1D-prevent low BG. 1E-understand how food/exercise affects low BG. □2 I WOULD USE ONLY the meter and strips my insurance company pays for, even if a more accurate meter was available. □3 I USE MY CURRENT METER BECAUSE 3A-my HCP gave it to me. 3B-my insurance company covers the strips. 3C-I think it is the most accurate meter. □4 I WOULD SWITCH meters for a more accurate meter. □5BEING ABLE TO APPLY MORE BLOOD IS IMPORTANT 5A-as I have wasted test strips by not having enough blood to fill the strip 5B-as this would save test strips 5C-I would switch to a meter with this feature|1 hour|Since subjects had the option to provide No Response at all to a question, some questionnaire statements had less than 146 participant responses possible (see numbers in parentheses)||participants|||Number
29278|NCT01614613|Secondary|Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)|Variability of each meter system was determined by calculating the Standard Deviation derived from each meter's differences between Blood Glucose Meter (BGMS)results and corresponding YSI Blood Glucose (BG) results.|6 hours|Same numbers (538) of BG results were possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 438 unmodified capillary samples and 100 samples were modified (21 to 496 mg/dL).||Standard Deviation|Participants||Number
29297|NCT01614470|Secondary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 1: From signing of informed consent up to Week 20|Safety Set for Part 1 included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).||participants|||Number
29279|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL|"Using samples with BG >180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values was compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (231) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 181 unmodified capillary samples >180 mg/dL and 50 samples were modified by adding glucose solution.||mg/dL|Participants|Standard Error|Least Squares Mean
29280|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL|"Using samples with BG 70 mg/dL to 180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all|(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (172) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided all 172 capillary samples (70 to 180 mg/dL) and no samples were modified.||mg/dL|Participants|Standard Error|Least Squares Mean
29281|NCT01614613|Primary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)|"Using samples with BG < 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (135) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 85 unmodified capillary samples <70 mg/dL and 50 samples were modified by glycolyzing them.||mg/dL|Participants|Standard Error|Least Squares Mean
29282|NCT01614600|Primary|Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2|Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.|Baseline, Week 1, Week 2|Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.||Units on a scale||Standard Deviation|Mean
29283|NCT01614574|Secondary|Change From Baseline in CCL18 Levels||Baseline to week 51|||(ng/mL)||Standard Deviation|Mean
29284|NCT01614574|Secondary|Change From Baseline in Plasma Chitotriosidase Levels||Baseline to week 51|||(nmol/mL/h)||Standard Deviation|Mean
29285|NCT01614574|Secondary|Change From Baseline in Spleen Volume, Normalized to Body Weight||Baseline to week 51|||(% of Body Weight)||Standard Deviation|Mean
29286|NCT01614574|Secondary|Change From Baseline in Liver Volume, Normalized to Body Weight||Baseline to week 51|||(% of Body Weight)||Standard Deviation|Mean
29287|NCT01614574|Secondary|Change From Baseline in Platelet Count||Baseline to week 51|||(x 10`{super 9}/L)||Standard Deviation|Mean
29288|NCT01614574|Secondary|Change From Baseline in Hemoglobin Concentration||Baseline to week 51|||(g/dL)||Standard Deviation|Mean
29289|NCT01614574|Primary|Number of Patients With Concomitant Medication||Baseline to week 51|||participants|||Number
29290|NCT01614574|Primary|Number of Infusion- Related Adverse Events||Baseline to week 51|||events|||Number
29291|NCT01614574|Primary|Development of Anti-velaglucerase Alfa Antibody||Baseline to week51|||participants|||Number
29292|NCT01614574|Primary|Number of Treatment Emergent Adverse Events (TEAE)||Baseline to week 51|||events|||Number
29293|NCT01614574|Primary|Number of Severe Adverse Events (SAE)||Baseline to week 51|||events|||Number
29294|NCT01614509|Primary|Changes of Central Retinal Thickness|Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection|baseline, 1, 3, 6 months after injection|Participants who were finished 6 months follow up period.||micrometer||Standard Deviation|Mean
29295|NCT01614509|Secondary|Additional Intravitreal Bevacizumab Injection|Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months|6 months|We evaluated mean times of additional intravitreal injection because of recurrent macular edema within participants who who were finished 6 months follow up periods.||times of injection||Standard Deviation|Mean
29296|NCT01614470|Secondary|Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 2: Week 20 up to Week 40|Safety Set for Part 2 included all subjects who received at least 1 dose of study drug (ivacaftor).||participants|||Number
29298|NCT01614470|Secondary|Part 2: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through 24 Weeks of Treatment (Week 36 Visit)|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Change in CFQ-R respiratory domain score over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.||units on a scale||Standard Deviation|Mean
29299|NCT01614470|Secondary|Part 1: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 8|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||units on a scale||Standard Deviation|Mean
29300|NCT01614470|Secondary|Part 2: Change From Baseline in Sweat Chloride Through 24 Weeks of Treatment (Week 36 Visit)|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Change in sweat chloride over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|"FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure. Here n signifies those subjects who were evaluable for this measure at given time point."||mmol/L||Standard Deviation|Mean
29301|NCT01614470|Primary|Part 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through 24 Weeks of Treatment (Week 36 Visit)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Absolute change in percent predicted FEV1 over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2, as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.||percent predicted of FEV1||Standard Deviation|Mean
29302|NCT01614470|Secondary|Part 1: Change From Baseline in Sweat Chloride Through Week 8|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||millimole per liter (mmol/L)||Standard Deviation|Mean
29303|NCT01614470|Secondary|Part 2: Change From Baseline in Body Mass Index (BMI) at 24 Weeks of Treatment (Week 36 Visit)|BMI was defined as weight in kg divided by height in m^2. Change in BMI over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.||kg/m^2||Standard Deviation|Mean
29304|NCT01614470|Secondary|Part 1: Change From Baseline in Body Mass Index (BMI) at Week 8|BMI was defined as weight in kilogram (kg) divided by height in meters^2 (m^2). Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||kg/m^2||Standard Deviation|Mean
29305|NCT01614470|Primary|Part 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."||percent predicted of FEV1||Standard Deviation|Mean
29306|NCT01614457|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence, including clinically significant clinical laboratory assessments which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Baseline up to follow-up (3 to 4 weeks after last dose [last dose = Week 24])|Safety Set included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).||participants|||Number
29307|NCT01614457|Secondary|Time to First Pulmonary Exacerbation|Number of events (pulmonary exacerbation) during the pre-specified time intervals were reported. A subject without an exacerbation before withdrawal from the study was considered censored at the time of withdrawal, and a subject without an exacerbation who completes the study period was considered censored at the end of the analysis period.|Day 0 to 15, Day 16 to 56, Day 57 to 112, Day 113 to 168|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||events|||Number
29308|NCT01614457|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated subject-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."||units on a scale||Standard Error|Least Squares Mean
29309|NCT01614457|Secondary|Change From Baseline in Sweat Chloride Through Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
29310|NCT01614457|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|Baseline, Week 24|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||kg/m^2||Standard Error|Least Squares Mean
29311|NCT01614457|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years.|Baseline, Week 24|Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||percent predicted of FEV1||Standard Error|Least Squares Mean
29312|NCT01614249|Primary|Change in BDI-II Depressive Symptom Scores|Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.|8 weeks|Only participants who completed the 8-weeks trial period were included in the final analysis of primary outcome. Per protocol analysis Post-intervention BDI-II scores at week 8 minus baseline BDI-II scores at week 0||scores on BDI-II scale||95% Confidence Interval|Mean
29313|NCT01613599|Secondary|Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab|"A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above.~Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Re-treated safety population included all participants who received more than one course of rituximab.||events per 100 patient year|Participants|95% Confidence Interval|Number
29314|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab|"An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above.~Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Re-treated safety population included all participants who received more than one course of rituximab.||events per 100 patient year|Participants|95% Confidence Interval|Number
29315|NCT01613599|Secondary|Incidence Rate of Adverse Events With Fatal Outcomes|Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Participants|95% Confidence Interval|Number
29316|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events|"An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above.~Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Participants|95% Confidence Interval|Number
29317|NCT01613599|Secondary|Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer|Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Participants|95% Confidence Interval|Number
29318|NCT01613599|Secondary|Incidence Rate of Serious Vascular Adverse Events|"A serious vascular adverse event was defined as an SAE coded to the MedDRA vascular system organ class. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above.~Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Participants|95% Confidence Interval|Number
29319|NCT01613599|Secondary|Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion|"An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above."|From the start of an infusion up to 24 hours following infusion completion (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||percentage of participants|||Number
29320|NCT01613599|Secondary|Incidence Rate of Serious Cardiac Adverse Events|"A serious cardiac adverse event was defined as an SAE that was coded to the Medical Dictionary for Regulatory Activities (MedDRA) cardiac system organ class. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above.~Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Participants|95% Confidence Interval|Number
29321|NCT01613599|Secondary|Percentage of Participants With a Serious Infusion-related Reaction|"A serious infusion-related reaction was defined as an SAE during or within 24 hours after any rituximab infusion and considered infusion related by the Principal Investigator. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above."|From the start of an infusion up to 24 hours following infusion completion (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||percentage of participants|||Number
29322|NCT01613599|Primary|Incidence Rate of Serious Infections|"A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. An SAE was defined as any adverse event that fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above.~Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years."|From first dose until participant withdrawal or the date of latest participant visit (up to 37 months)|Safety population included all participants who received any dose of rituximab and whose safety data was verifiable.||events per 100 patient year|Participants|95% Confidence Interval|Number
29323|NCT01613417|Secondary|Accuracy for Tumor Characterization|Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment|5-10 minutes Postdose|Subjects with histologically confirmed lesions||participants|||Number
29324|NCT01613417|Secondary|Lesion Detection|Lesion detection rate by contrast agent and reader|5-10 minutes Postdose|Per protocol patients with histologically confirmed lesions||participant exams|||Number
29325|NCT01613417|Secondary|Percentage Signal Intensity Enhancement on Postdose Images|Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population||percentage signal intensity enhancement|Participants|Standard Deviation|Mean
29326|NCT01613417|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population||signal intensity|Participants|Standard Deviation|Mean
29327|NCT01613417|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
29328|NCT01613417|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
29329|NCT01613417|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
29330|NCT01613417|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|||participant exams|Participants||Number
29331|NCT01613417|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations||participant exams|Participants||Number
29332|NCT01613378|Secondary|Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months|"The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud’s phenomenon, secondary Sjogren’s syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded YES to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable"|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.||participants|||Number
29333|NCT01613378|Secondary|Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months|The extra-articular RA manifestations ascertained were the nodules, Raynaud’s phenomenon, secondary Sjogren’s syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data.|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.||percentage of participants|||Number
29334|NCT01613378|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the ESR assessment were included in this analysis.||mm/hr||Standard Deviation|Mean
29335|NCT01613378|Secondary|Change From Baseline in C-Reactive Protein (CRP)|The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the CRP assessment were included in this analysis.||mg/L||Standard Deviation|Mean
29336|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Patient Assessment of Fatigue on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
29337|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Pain on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
29338|NCT01613378|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
29339|NCT01613378|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
29340|NCT01613378|Secondary|Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Duration of Morning Stiffness on the VAS were included in this analysis.||units on a scale||Standard Deviation|Mean
29341|NCT01613378|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the DAS28 assessment were included in this analysis.||units on a scale||Standard Deviation|Mean
29342|NCT01613378|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Swollen Joint Count were included in this analysis.||swollen joints||Standard Deviation|Mean
29343|NCT01613378|Secondary|Change From Baseline in Tender Joint Count (TJC)|Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Tender Joint Count were included in this analysis.||tender joints||Standard Deviation|Mean
29344|NCT01613378|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||At 6 months|All participants enrolled in the study.||percentage of participants||95% Confidence Interval|Number
29345|NCT01613339|Secondary|Activities-specific Balance Confidence Scale|16 item questionnaire that investigates balance self-efficacy. Each items is a question; How secure are you that you will not fall when you...sweep the floor? The participant are asked to grade his/hers feeling of secutiry from 0, 10, 20 and so on up to 100. 0 is regarded low balance self-efficacy. The item responses are summed and divided by 16.|Change from baseline in Activities-specific Balance confidence scale at 9 weeks|||units on a scale||Standard Deviation|Mean
29346|NCT01613339|Primary|Bergs Balance Scale|"Test of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0.~The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance."|Change from baseline in Bergs balance scale at 9 weeks|||units on a scale||Standard Deviation|Mean
29347|NCT01613339|Secondary|Timed Up and Go Test|test of functional mobility. Time is taken in seconds. The participants sits on a chair with armrests are then asked to rise, walk 3 meters, turn and walk back and sit down.|Change from baseline in Timed Up and Go test at 9 weeks|||seconds||Standard Deviation|Mean
29348|NCT01613326|Secondary|Mean Daily, Daytime and Nighttime (Combined) Symptom Scores Over the 12 Week Treatment Period|Participants completed eDiaries providing scores 0 to 3 for symptoms: Cough and wheeze (none, mild, moderate, severe); sputum volume (none, less than 5 mL, 5-25 mL, >25 mL); sputum color (none, white-grey, yellow, green); lowest level of activity causing breathlessness (never or only when running, when walking uphill or upstairs, when walking on flat ground, at rest). Symptoms in the morning, for the previous night (no waking due to symptoms, woke up once due to symptoms, woke up more than once due to symptoms, woke up frequently or could not sleep due to symptoms). Symptoms experienced during the day that had prevented them for performing normal activities (not at all, a little, quite a lot, completely). The mean change from baseline in the total scores and in the individual scores was summarized by treatment. Only participants with a value at both baseline and post-baseline were included. Possible total scores 0-18 (night); 0-36 (day). A higher score means worsening of symptoms.|12 weeks|The per-protocol set included all randomized patients who received at least one dose of study drug. Only patients with a value at both baseline and post-baseline are included.||units on a scale||Standard Deviation|Mean
29349|NCT01613326|Secondary|Event Free Rate at Weeks 4, 8 and 12 After Treatment|Event free rate was calculated as a percentage of participants who did not experience any moderate or severe COPD exacerbation leading to hospitalization/treatment with systemic corticosteroids/treatment with antibiotics. The event free rate reflects the percent of patients who did NOT have an exacerbation by 4, 8 and 12 weeks. Event-free rates are calculated at the end of the specified weeks (i.e. Day 29, Day 57 and Day 85) by the Kaplan Meier method.|Weeks 4, 8 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations and described as patients with moderate to severe exacerbations were included in this analysis.||percentage of participants||95% Confidence Interval|Number
29350|NCT01613326|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (5 Min-4 h) Post-dose|"Forced Expiratory Volume in one second (FEV1) was measured with spirometry conducted according to internationally accepted standards.~Area Under the Curve (AUC) is calculated using the trapezoidal rule using the existing FEV1 measurements (i.e., the missing FEV1 measurements are not interpolated).~ANCOVA model: FEV1 AUC = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.||Liters||Standard Error|Least Squares Mean
29372|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose|Phonophobia is sensitivity to loud sounds.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29373|NCT01613248|Primary|Number of Participants Who Discontinued From Study Due to Adverse Events||Up to 5 weeks post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.||participants|||Number
29351|NCT01613326|Secondary|Forced Vital Capacity (FVC) at Each Time-point by Visit|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. ANCOVA model: FVC = treatment + baseline FVC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
29352|NCT01613326|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Each Time-point by Visit|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) model: FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
29353|NCT01613326|Secondary|Inspiratory Capacity (IC) at Each Time-point, by Visit|IC was measured with spirometry conducted according to internationally accepted standards. ANCOVA model: IC = treatment + baseline IC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Day 1), (-20 min, 25 min, 23 h 40 min Week 4),(-20 min, 25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
29354|NCT01613326|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) During 5 Min to 4 Hours Post-dose, at Day 1 and Week 12|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded during first 4 hours post dose. ANCOVA model: Peak FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). Center is included as a random effect nested within region. This analysis excludes values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|5 min to 4 hours post-dose at Day 1 and Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations||Liters||Standard Error|Least Squares Mean
29355|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 4|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.~Trough FEV1 is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. Trough assessments taken outside 22 h 45 min - 24 h 15 min are excluded from this analysis.~ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and Week 4|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.||Liters||Standard Error|Least Squares Mean
29356|NCT01613326|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 12 Week Treatment|"A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.~Baseline mean daily, daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs. Only patients with a value at both baseline and post-baseline visits were included."|Baseline and Day 1 to Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with a value at both baseline and post-baseline visits were included.||puffs||Standard Deviation|Mean
29357|NCT01613326|Secondary|St. George's Respiratory Questionnaire Total Score After 12 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. ANCOVA model: SGRQ total score = treatment + baseline SGRQ score + baseline ICS use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region).|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.||Units on a scale||Standard Error|Least Squares Mean
29358|NCT01613326|Secondary|Transition Dyspnea Index (TDI) Focal Score After 4 Weeks and 12 Weeks of Treatment|"Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.~ANCOVA model: TDI focal score = treatment + Baseline dyspnea index (BDI) + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Weeks 4 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.||Units on a scale||Standard Error|Least Squares Mean
29374|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 14 Days Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 14 days post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.||participants|||Number
29359|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Analysis of Superiority)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and had available data for analysis.||Liters||Standard Error|Least Squares Mean
29360|NCT01613326|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23hours 15min and 23 hours 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.||Liters||Standard Error|Least Squares Mean
29361|NCT01613313|Secondary|Relative Change in Volume of the Lipoma|A secondary outcome is the relative change in volume of the lipoma as determined by MRI. This outcome will be analyzed as the change from baseline to 6 months post injection.|Baseline and 6 months post injection of study drug|Analysis is based on the population that consists of all subjects who are enrolled and received administration of study drug||Percent reduction from baseline||Standard Deviation|Mean
29362|NCT01613313|Primary|Change in Visible Surface Area of the Lipoma|The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.|Baseline and Six months post injection of study drug|Analysis population consists of all subjects who were enrolled and received the administration of study drug.||Percent change from baseline||Standard Deviation|Mean
29363|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose|TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29364|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose|TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29365|NCT01613248|Secondary|Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29366|NCT01613248|Secondary|Percentage of Participants Reporting SPR 2-48 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29367|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29368|NCT01613248|Secondary|Percentage of Participants Reporting SPF 2-48 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29369|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29370|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose||2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29371|NCT01613248|Secondary|Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose|Photophobia is sensitivity to bright light.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29375|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 48 hours post-dose|All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment.||participants|||Number
29376|NCT01613248|Primary|Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose|PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29377|NCT01613248|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose|PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29378|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29379|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29380|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29381|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 90|4 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29382|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29383|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29384|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 140|5 women in the Mirena + Estradiol Gel arm, and 7 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29385|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29398|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 6|Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 6|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||participants|||Number
40463|NCT01451398|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/Subject-Month|||Number
29386|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 0|One woman in the Mirena + Placebo Gel arm did not provide complete data for this outcome measure; thus she was not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29387|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 0|Two women in the Mirena + Placebo Gel did not provide complete data for this outcome measure; thus they were not included in the analysis for this timepoint.||scores on a scale||Standard Error|Mean
29388|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 0|||scores on a scale||Standard Error|Mean
29389|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 0|||scores on a scale||Standard Error|Mean
29390|NCT01613027|Secondary|Percentage of Serious ADRs|"Percentage of serious ADRs resolved and ongoing at the time of study completion was reported.~An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of serious ADRs|Participants||Number
29391|NCT01613027|Secondary|Percentage of Serious AEs|"Percentage of serious AEs resolved and ongoing at the time of study completion was reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of serious AEs|Participants||Number
29392|NCT01613027|Secondary|Percentage of Non-Serious ADRs|"Percentage of non-serious ADRs at the time of study completion was reported.~An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of non-serious ADRs|Participants||Number
29393|NCT01613027|Secondary|Percentage of Non-Serious AEs|"Percentage of non-serious AEs resolved and ongoing at the time of study completion were reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of non-serious AEs|Participants||Number
29394|NCT01613027|Secondary|Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity|"Percentage of participants with any non-serious AE and any serious AE by intensity (mild, moderate, severe) was reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants|||Number
29395|NCT01613027|Secondary|Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. AEs of special interest includes progressive multifocal leukoencephalopathy (PML), any encephalopathy, hepatitis B or hepatitis B reactivation, gastrointestinal perforation, tuberculosis (TB) or TB reactivation, opportunistic infections, and malignancies.|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants|||Number
29396|NCT01613027|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ)|"The M-HAQ is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.~Clinically meaningful improvement was defined as minimum clinically significant reduction from baseline of ≥0.22 at the respective time point."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data for change from baseline at Month 6 and Month 12 are included for participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
29397|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 12|Reasons for discontinuation from baseline to Month 12 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||participants|||Number
29399|NCT01613027|Secondary|Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12||Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants|||Number
29400|NCT01613027|Secondary|Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5.0 milligrams per liter (mg/L). A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data at Month 6 and Month 12 are included for participants who had assessments for CRP.||mg/L||Standard Deviation|Mean
29401|NCT01613027|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||mm/hour||Standard Deviation|Mean
29402|NCT01613027|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||tender joints||Standard Deviation|Mean
29403|NCT01613027|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12|SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||swollen joints||Standard Deviation|Mean
29404|NCT01613027|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Month 6, and baseline and Month 12, and reported as the percentage of participants with response overall, good response, moderate response, and no response measured at each time point. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||percentage of participants||95% Confidence Interval|Number
29405|NCT01613027|Primary|Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12|DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient’s global assessment of disease activity (100-millimeter [mm] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.||units on a scale||Standard Deviation|Mean
29406|NCT01612858|Secondary|Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent|Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy|12 weeks|Only participants with baseline and post insulin sensitizing treatment magnetic resonance spectrosocpy were included in this analysis.||percentage of hepatic fat||Standard Deviation|Mean
29407|NCT01612858|Primary|Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent|Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone|3 months|Only participants with baseline and post insulin-sensitizing treatment euglycemic-hyperinsulinemic clamp were included in this analysis||mg/kg lean body mass/min||Standard Deviation|Mean
29408|NCT01612702|Secondary|Wound Complication|Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.|within 30 days after surgery|||participant|||Number
29409|NCT01612702|Secondary|Pain Level|A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).|6 to 24 hours after surgery|||units on a scale||Standard Deviation|Mean
29410|NCT01612702|Primary|Incidence of Nausea and Vomiting|A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting|within 72 hours after surgery|||percentage of participant||95% Confidence Interval|Number
29411|NCT01612676|Secondary|Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram|Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).|Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion|The safety analysis set comprised of all allocated and dosed patients and were analyzed according to the actual dosing regimen received.||patients|||Number
29412|NCT01612676|Secondary|Mortality|Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||patients|||Number
29413|NCT01612676|Primary|Time to Septic Shock Resolution|"The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration.~Time to all but one patient out of septic shock is presented."|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||Hours|||Number
29414|NCT01612676|Primary|Infusion Rate of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.|Day 1 up to Day 7|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.||µg/kg/min||Standard Deviation|Mean
29415|NCT01612676|Primary|Cumulative Dose of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.|Day 1 up to Day 7|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.||µg/kg||60% Confidence Interval|Mean
29416|NCT01612676|Primary|Infusion Rate of FE 202158|Infusion rate of FE 202158 was presented from Day 1 up to Day 7.|Day 1 up to Day 7|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||ng/kg/min||Standard Deviation|Mean
29417|NCT01612676|Primary|Cumulative Dose of FE 202158|Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.|Day 1 up to Day 7|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||ng/kg||60% Confidence Interval|Mean
29418|NCT01612676|Secondary|Graded Morbidity|Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||patients|||Number
29419|NCT01612676|Secondary|Morbidity Assessment|Percentage of all the “Days alive and out/free of” intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||percentage of days within 28 days|||Number
29420|NCT01612676|Secondary|Summary of Investigator Reported Outcomes|Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.|Day 1 up to Day 2|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||Score on scale||Standard Deviation|Mean
29421|NCT01612676|Secondary|Fluid Balance|The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.|Day 1 up to Day 7|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||mL/kg||60% Confidence Interval|Mean
29422|NCT01612676|Secondary|Urinary Output|The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.|Day 1 up to Day 7|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||mL/kg||60% Confidence Interval|Mean
29423|NCT01612676|Primary|Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine|Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented.|Day 1 up to Day 7|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.||Percentage of patients||60% Confidence Interval|Number
29424|NCT01612494|Secondary|Change in Nausea and Vomiting||from initial symptoms to 2-3 days post discharge||||||
29425|NCT01612494|Primary|Change in Pain|Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.|Following therapy to 2-3 days post discharge|||units on a scale||Standard Deviation|Mean
29426|NCT01612156|Secondary|Embarrassment With Pelvic Floor Examination|The participants will be asked to report their level of embarrasment during the exam using a Likert scale from 1 (no embarrassment) to 5 (most embarrasment possible) at 30 minutes after completion of the exam.|30 minutes|||On 5 point Likert scale||Full Range|Median
29427|NCT01612156|Primary|Pain During the Pelvic Floor Examination|"Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam.~The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible)."|30 minutes after completion of exam|||units on Wong Baker pain scale||Standard Deviation|Mean
29428|NCT01612000|Primary|The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.||42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.||titer||95% Confidence Interval|Geometric Mean
29429|NCT01612000|Secondary|Long-term Safety|Incidence of Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCIs) and Adverse Events of Special Interest (AESIs) over 12 months following vaccination. Study subjects were followed every three months (for one year following Day 42) by telephone and visit for reports of SAEs, NOCIs, and AESIs.|13 Months|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.||participants|||Number
29430|NCT01612000|Secondary|Reactogenicity Immediately After Each Injection, Extending to Day 7.|Solicited events of local and systemic reactogenicity Days 0-7. These events are expected to occur and not considered or recorded as Adverse Events.|7 Days|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.||participants|||Number
29450|NCT01611883|Secondary|Change in Glycoalbumin From Baseline|Glycoalbumin is a blood marker used to assess blood glucose control over time and is reported as a percentage (%). Serum glycoalbumin levels were assessed at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.||Percent||95% Confidence Interval|Least Squares Mean
29431|NCT01612000|Primary|The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.|42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.||percentage of participants||95% Confidence Interval|Number
29432|NCT01611974|Secondary|Half-Life (T½) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||hours||Standard Deviation|Mean
29433|NCT01611974|Secondary|Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||h*ug/mL||Standard Deviation|Mean
29434|NCT01611974|Secondary|Time of Last Non-Zero Concentration (Tlast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||hours||Standard Deviation|Mean
29435|NCT01611974|Secondary|Time to Maximum Concentration (Tmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.||hours||Standard Deviation|Mean
29436|NCT01611974|Secondary|Maximum Concentration (Cmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations||ug/mL||Standard Deviation|Mean
29437|NCT01611974|Secondary|Time to CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time of the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA after achievement of undetectable plasma CMV DNA in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1; as assessed by the central laboratory. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. The median values are Kaplan-Meier estimates.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||days||95% Confidence Interval|Median
29438|NCT01611974|Secondary|Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time from first dose of study drug to first undetectable plasma CMV DNA within 6 weeks and at any time during the study, defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days; as assessed by the central laboratory. The median values are Kaplan-Meier estimates.|6 weeks after start of treatment, within 36 weeks of start of treatment|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||days||95% Confidence Interval|Median
29439|NCT01611974|Secondary|Number of Participants With CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. CMV recurrence was defined as achievement of undetectable plasma CMV DNA at any time after Day 1 in at least 2 consecutive samples separated by at least 5 days, followed by detectable plasma CMV DNA in at least 2 consecutive samples separated by at least 5 days (assessed by the central laboratory). For the analyses of CMV recurrence, the first of 2 consecutive confirmed undetectable plasma CMV DNA results had to be on-treatment. CMV DNA PCR values of ≥200 copies/mL were considered detectable. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||participants|||Number
29440|NCT01611974|Primary|Number of Participants With a Treatment Emergent Adverse Event (TEAE).|Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug.|25 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||participants|||Number
29441|NCT01611974|Primary|Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by >/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).|6 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.||participants|||Number
29442|NCT01611883|Secondary|Percent Change in Non–HDL-cholesterol From Baseline|Non-HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
29443|NCT01611883|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline|HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
29444|NCT01611883|Secondary|Percent Change in Triglycerides From Baseline|Triglycerides levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
29445|NCT01611883|Secondary|Percent Change in Total Cholesterol (TC) From Baseline|TC levels measured at Baseline and after 24 weeks of treatment.|Baseline and Week 24|FAS defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
29446|NCT01611883|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline|LDL-C levels measured at baseline and after 24 weeks of treatment|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.||Percent Change||95% Confidence Interval|Least Squares Mean
29447|NCT01611883|Secondary|Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes|The percentage of participants who had changes to their medications used to treat their diabetes, other than small changes in insulin dosing (± 5 Units), were reported and summarized.|Up to 24 weeks|AST Population defined as all participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
29448|NCT01611883|Secondary|"Percentage of Participants With Adverse Event (AE) Exacerbation of Diabetes"|The Investigator took into account a participant’s index of blood glucose control, diabetes medications, and compliance to diet and exercise therapy to assess overall control of the participant’s diabetes and to determine if the participant’s diabetes worsened. Participants who experienced the AE “Exacerbation of Diabetes ” (verbatim term) were recorded.|up to 24 weeks|All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
29449|NCT01611883|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
40464|NCT01451398|Secondary|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population||percentage of participants|||Number
29451|NCT01611883|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline|HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.||Percent||95% Confidence Interval|Least Squares Mean
29452|NCT01611857|Secondary|Time to Progression in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until progressive disease, expected 18 months.|The analysis was performed on all participants (N = 34) in the Phase II portion of the study.||months||95% Confidence Interval|Median
29453|NCT01611857|Secondary|Overall Survival in Phase II Dose Expansion|Defined as the time from first treatment until death from any cause.|every 8 weeks until treatment discontinuation, an expected average of 18 months, then every 12 weeks thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N=34) for all participants in the Phase II portion of the study.||months||95% Confidence Interval|Median
29454|NCT01611857|Secondary|Progression Free Survival in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until treatment discontinuation, projected 18 months and then every 3 months thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N = 34) for all participants in the Phase II portion of the study. Median follow-up was 15 months (3-21 months)||months||95% Confidence Interval|Median
29455|NCT01611857|Primary|The Incidence of Dose Limiting Toxicities (DLT) in Phase I Dose Escalation|Using a standard 3+3 design participants were enrolled in dose-escalating cohorts to determine the maximum tolerated dose (MTD) of tivantinib when given with FOLFOX (5-FU 400 mg/m^2, continuous IV 5-FU 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2). MTD is defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.|14 Days (1 cycle)|Patients were assessed for DLT if they received at least 85% of the scheduled doses of study drugs in cycle 1. In the Tivantinib 120 mg cohort two participants were replaced due to missed drug. In the Tivantinib 360 mg cohort one patient was replaced due to an allergic reaction to oxaliplatin.||participants|||Number
29456|NCT01611779|Secondary|Epworth Sleeping Scale (ESS)|0 to 24 (high value represents worse outcome)|1, 3, 12 months|Five (5) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 4 had follow-up data at 3 months, and 2 had follow-up data at 12 months.||units on a scale||Standard Deviation|Mean
29457|NCT01611779|Secondary|Snoring Scale (VAS)|0 to 10 (high value represents worse outcome)|1 week; 1, 3, 12 months|Four (4) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 3 had follow-up data at 3 months, and 2 had follow-up data at 12 months.||units on a scale||Standard Deviation|Mean
29458|NCT01611779|Secondary|Functional Outcomes and Sleep Questionnaire (FOSQ)|Questionnaire: 0 to 120 (high value represents better outcome)|1, 3, 12 month|Four (4) of 5 total subjects had data at baseline and follow-up data.||units on a scale||Standard Deviation|Mean
29459|NCT01611779|Secondary|Apnea Hypopnea Index|0 to >30/hour (high value represents worse outcome)|3 and 12 months|Three (3) of 5 subjects returned for 3 month follow-up and 2 of 5 subjects returned for the 12 month follow-up.||events/hour||Standard Deviation|Mean
29460|NCT01611779|Primary|Complications|Evaluate safety of the device|3 months|||Participants|||Count of Participants
29461|NCT01611779|Primary|Place the Implant and Stabilize the Tongue|Ability to place the implant and stabilize the tongue|Up to 7 weeks after the procedure|||Participants|||Count of Participants
29462|NCT01611571|Secondary|Change in FN BMD at 18 Months|Change in the Femoral Neck BMD at 18 month|18 months|||% change in TH BMD||Standard Deviation|Mean
29463|NCT01611571|Secondary|New Morphometric Vertebral Fractures|counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study|baseline through 18 months|||vertebral fracture|||Number
29464|NCT01611571|Secondary|Change in Forearm Bone Density|change in 1/3 radius of forearm bone density as measured by DXA|baseline and 18 months|||% change in 1/3 Radius BMD||Standard Deviation|Mean
29465|NCT01611571|Secondary|Change in Hip Bone Density|change in hip bone density measured by DXA|baseline and 18 months|||% change in TH BMD||Standard Deviation|Mean
29466|NCT01611571|Primary|Change in Spine Bone Density|change in spine bone density at 18 months measured by DXA 18 and 24 months|18 months|||% change in LS BMD||Standard Deviation|Least Squares Mean
29467|NCT01611558|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|From first dose to within 90 days of last study dose|All participants who received at least 1 dose of study drug||Participants|||Number
29468|NCT01611558|Secondary|Best Overall Response Rate (BORR)|BORR is defined as the percentage of participants who received treatment and, at any time during the study, had a best response of complete response or partial response, as confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria for patients with cancer antigen 125 (CA125) levels elevated to twice the upper limit of normal at baseline, divided by the total number of evaluable participants in the arm.|From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)|All participants who received study drug. n=number of evaluable participants||Percentage of participants||95% Confidence Interval|Number
29863|NCT01606228|Secondary|Quality of Sleep at Baseline|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29469|NCT01611558|Primary|Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.|Day 1, first dose, to within 90 days of last dose in Induction Phase|All participants who received at least 1 dose of study drug||Participants|||Number
29470|NCT01610791|Primary|Percentage of Participants With Adverse Events|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants who received at least one dose of study medication where at least one post-baseline assessment of safety was available.||percentage of participants|||Number
29471|NCT01610791|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The change in ESR was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm/hr||Standard Deviation|Mean
29472|NCT01610791|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase inflammatory marker. Levels of CRP increase with inflammation. The change in CRP was determined as the difference in values from baseline and at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mg/dL||Standard Deviation|Mean
29473|NCT01610791|Secondary|Patient Assessment of of Pain (VAS)|"The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no pain and the right-hand extreme of the line (100 mm) was described as unbearable pain. The change in participant's perception of pain was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm||Standard Deviation|Mean
29474|NCT01610791|Secondary|Physician's Global Assessment of Disease Activity (VAS)|"The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity. The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician. The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm||Standard Deviation|Mean
29475|NCT01610791|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm||Standard Deviation|Mean
29476|NCT01610791|Secondary|Health Assessment Questionnaire (HAQ)|HAQ was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple-choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The change in HAQ was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||score on a scale||Standard Deviation|Mean
29477|NCT01610791|Secondary|Swollen and Tender Joint Counts|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The following 28 joints were assessed by the physician for tenderness : metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The change in SJC and TJC was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||joints||Standard Deviation|Mean
29478|NCT01610791|Secondary|Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria|The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
29479|NCT01610791|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants with a DAS28 score <2.6 were considered to have achieved remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
29480|NCT01610791|Secondary|Time to Achieve Clinically Meaningful Reduction in DAS28|A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units. Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||days||Standard Deviation|Mean
29481|NCT01610791|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
29482|NCT01610791|Secondary|Percentage of Participants by DAS28 Response Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 =low disease activity, DAS28 >3.2 to ≤5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
29483|NCT01610791|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
29484|NCT01610791|Secondary|Percentage of Participants With Lipid Elevations by Study Visit|Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL. Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable <200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low <40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal <150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population; n (number) = number of participants assessed for the parameter at a given visit.||percentage of participants|||Number
29485|NCT01610791|Secondary|Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values|Levels of LDL and TC were measured in milligrams/deciliter (mg/dL). Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.|Baseline through Week 24|Safety population||mg/dL||Standard Deviation|Mean
29486|NCT01610791|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value|The difference between baseline and highest values until Week 24 of ALT and AST. The values are measures as international units per liter (UI/L). The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.|Baseline through Week 24|Safety Population||UI/L||Standard Deviation|Mean
29487|NCT01610791|Secondary|Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit|Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.|Weeks 4, 8, 12, 16, 20, and 24|All enrolled participants were included in the analysis||percentage of participants|||Number
29488|NCT01610713|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Open-label Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects that considered their condition to be better or much better at the end of open-label treatment is presented.|End of Part B (week 10)|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||participants|||Number
29489|NCT01610713|Secondary|Change From Part A Mean Ten-metre Mobility Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 10 Metre Mobility Score is a four point scale assessing a subject’s level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates and improvement.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||time (seconds)||Standard Deviation|Mean
29490|NCT01610713|Secondary|Change From Part A Mean Bladder Problems Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in bladder problems from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29491|NCT01610713|Secondary|Change From Part A Mean Tremor Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in tremor from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29534|NCT01610700|Secondary|Change From Baseline in Tremor Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
38315|NCT01474200|Secondary|CLINICAL: Days Alive and Out of Hospital at 30 and 90 Days After Discharge|Number of days patients were alive and out of the hospital.|Within 30 and 90 days after hospital discharge|||Days||Standard Deviation|Mean
29492|NCT01610713|Secondary|Change From Part A Mean Muscle Spasm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates and improvement in spasms from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29493|NCT01610713|Secondary|Change From Part A Mean Pain Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in pain from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29494|NCT01610713|Secondary|Change From Part A Mean Spasticity Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement, as such a negative value indicates an imrovement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29495|NCT01610713|Secondary|Change From Part A Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Feeling upon wakening was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29496|NCT01610713|Secondary|Change From Part A Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29497|NCT01610713|Secondary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who recorded an adverse event during the 4 week open-label period is presented.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|This analyses set included all patients who took GW-1000-02 during the open-label treatment period.||participants|||Number
29498|NCT01610713|Secondary|Change From Mean Part A Sleep Quality 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29499|NCT01610713|Secondary|Change From Mean Part A Tremor Activities of Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29500|NCT01610713|Secondary|Change From Mean Part A Total Bladder Control Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The total bladder control test score was the sum score from fifteen questions, which were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
38316|NCT01474200|Secondary|CLINICAL: Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.|Death due to any cause.|Time from randomization to 90 days post-hospital discharge|||Percentage of Participants|||Number
29501|NCT01610713|Secondary|Change From Mean Part A Nine Hole Peg Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29502|NCT01610713|Secondary|Change From Mean Part A Total 28-item General Health Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29503|NCT01610713|Secondary|Change From Mean Part A Rivermead Mobility Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29504|NCT01610713|Secondary|Change From Mean Part A Fatigue Severity Scale Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29505|NCT01610713|Secondary|Change From Mean Part A Beck's Depression Inventory (BDI-II) Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The BDI-II was a 21-question multiple choice self-reported inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29506|NCT01610713|Secondary|Change From Mean Part A Total Adult Memory and Information Processing Battery Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29507|NCT01610713|Secondary|Change From Mean Part A Barthel Activities for Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The ability to undertake the different daily activities was assessed on scales of 0-1 to 3, with 0= poorest outcome and upper scores= best outcome. The total score was the sum of scores for each item; minimum score= 0, maximum score= 20. A change of two or greater in the total score indicating a clinically relevant change. A positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29535|NCT01610700|Secondary|Change From Baseline in Muscle Spasm Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29508|NCT01610713|Secondary|Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered ‘normal’. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29509|NCT01610713|Secondary|Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29510|NCT01610713|Secondary|Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29511|NCT01610713|Secondary|Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29512|NCT01610713|Secondary|Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29513|NCT01610713|Primary|Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)|This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.||units on a scale||Standard Deviation|Mean
29514|NCT01610700|Secondary|Change From Baseline in the Mean Total Adult Memory and Information Processing Battery Test Score at the End of Treatment|The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29722|NCT01608659|Primary|Average Total Dose Per Treatment Period|Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.||Units||Standard Deviation|Mean
29515|NCT01610700|Secondary|Change From Baseline in the Mean Guy's Neurological Disability Scale Score at the End of Treatment|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29516|NCT01610700|Secondary|Change From Baseline in the Mean Care-Giver Strain Index Score at the End of Treatment|The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29517|NCT01610700|Secondary|Change From Baseline in the Mean Reading Visual Acuity Test Score at the End of Treatment|Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29518|NCT01610700|Secondary|Change From Baseline in the Mean Short Orientation-Memory-Concentration Test at the End of Treatment|The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered ‘normal’. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29519|NCT01610700|Secondary|Change From Baseline in the Mean Barthel Activities for Daily Living Scale Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The ability to undertake the 10 different daily activities was assessed on scales of 0-1, 0-2 or 0-3, with 0 indicative of the poorest outcome and the highest possible score indicative of the best outcome. The summary parameter was the total score for each of the ten items, with a minimum possible score of 0 and a maximum possible score of 20. An increased score indicates an improvement, with a change of two or greater in the total score indicating a clinically relevant change. A positive value therefore indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29520|NCT01610700|Secondary|Change From Baseline in the Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29521|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29522|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Quality 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29523|NCT01610700|Secondary|Change From Baseline in the Mean Ten-metre Mobility Score at the End of Treatment|The 10 Metre Mobility Score is a four point scale assessing a subject’s level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates an improvement in condition.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||time (seconds)||Standard Deviation|Mean
29536|NCT01610700|Secondary|Change From Baseline in Pain Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29524|NCT01610700|Secondary|Change From Baseline in the Mean Tremor Activities of Daily Living Scale Score at the End of Treatment|The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29525|NCT01610700|Secondary|Change From Baseline in the Mean Total Bladder Control Test Score at the End of Treatment|The total bladder control test score was the sum score from fifteen questions were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient’s life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29526|NCT01610700|Secondary|Change From Baseline in the Mean Nine-hole Peg Test Score at the End of Treatment|The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29527|NCT01610700|Secondary|Change From Baseline in the Mean Total 28-item General Health Questionnaire Score at the End of Treatment|The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29528|NCT01610700|Secondary|Change From Baseline in the Mean Rivermead Mobility Index Score at the End of Treatment|The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a ‘yes’ / ‘no’ answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29529|NCT01610700|Secondary|Change From Baseline in the Mean Fatigue Severity Scale Questionnaire Score at the End of Treatment|The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29530|NCT01610700|Secondary|Change From Baseline in the Mean Beck's Depression Inventory (BDI-II) Score at the End of Treatment|This was a 21-question multiple choice self-report inventory. Subjects’ responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29531|NCT01610700|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29532|NCT01610700|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their Multiple sclerosis which was used at end of treatment to aid their memory regarding their symptoms at study start. The number of subjects that considered their condition to be better or much better at the end of treatment is presented.|6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||participants|||Number
29533|NCT01610700|Secondary|Change From Baseline in Bladder Problems Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29537|NCT01610700|Secondary|Change From Baseline in Spasticity Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29538|NCT01610700|Primary|Change From Baseline in Composite Primary Impairment Visual Analogue Scale Score at the End of 6 Weeks of Treatment|This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.||units on a scale||Standard Deviation|Mean
29539|NCT01610687|Secondary|Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
29540|NCT01610687|Secondary|Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
29541|NCT01610687|Secondary|Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
29542|NCT01610687|Secondary|Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
29543|NCT01610687|Secondary|Investigator Assessed Global Severity Score at Week 18|The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||participants|||Number
29544|NCT01610687|Secondary|Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.|Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||units on a scale||Standard Deviation|Mean
29545|NCT01610687|Secondary|Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment|A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.|up to 1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||sprays of study medication||Standard Deviation|Mean
29546|NCT01610687|Primary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who experienced an adverse event during the course of this extension study is presented|up to1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.||participants|||Number
29547|NCT01610596|Secondary|Overall Disease Severity Score (Improvement)|"The proportion of subjects rated a improved for ODS at Day 8 and Day 15. Improvement is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15|||percentage of participants|||Number
29548|NCT01610596|Secondary|Clinical Signs and Symptoms of Psoriasis|"The proportion of subjects rated a treatment success for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. Treatment success is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15|Analysis shown is based on the ITT population.||percentage of participants|||Number
29549|NCT01610596|Secondary|Percent Body Surface Area|Changes in percent BSA with active psoriasis in the Treatment Area|Baseline, Days 8 and 15|Analysis shown is based on the ITT population.||Change in %BSA||Standard Deviation|Mean
29561|NCT01610492|Secondary|Urine Membrane Attack Complex (MAC)|Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to 4 week post last dose||05/2017||||
29550|NCT01610596|Primary|Overall Disease Severity Score (Success)|"Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment success at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale."|Day 15|Analysis shown is the Intent-to-treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||percentage of participants|||Number
29551|NCT01610570|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of serious and non-serious adverse events see the adverse event module.|95 days|||participants|||Number
29552|NCT01610570|Secondary|Objective Response Rate (Complete Response (CR) + Partial Response (PR))|Objective response in children and adolescents with Ewings sarcoma - friend leukemia integration 1 transcription factor to mithramycin is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions.|1-2 months|This is a phase II objective, thus phase I groups are not shown here.||participants|||Number
29553|NCT01610570|Primary|Maximum Tolerated Dose (MTD) of Mithramycin|The MTD will be the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicity (DLT) (i.e., non-hematologic toxicity and hematologic toxicity) during cycle 1 (or 28 days) of therapy.|Cycle 1 of therapy (or 28 days)|MTD was not determined because based on pharmacokinetic data, a clinically relevant dose could not be obtained with the dose strategy. A minimum of 3 patients must be enrolled on a dose level to complete that dose level. Because only 2 patients were enrolled on phase I portion of the trial, dose level 1 was not completed and an MTD was not reached.|||||
29554|NCT01610557|Secondary|Change in Central Retinal Thickness Assessed by Optical Coherence Tomography (OCT) Central Subfield Mean Thickness (CSMT) From Baseline to 36 Weeks (Crossover Phase of the Study)|Optical Coherence Tomography (OCT) scans were graded in masked fashion by Duke University Reading Center (Durham, North Carolina). Per the initial protocol specifications, OCT scans were to be performed on a Cirrus OCT machine; however, some scans were performed on a Spectralis OCT machine at one of the sites due to technical difficulties. The protocol was amended to allow for Cirrus and Spectralis OCT scans at subsequent visits at the affected site. Spectralis values were then converted to Cirrus central subfield mean thickness (CSMT) values through a validated linear conversion function.|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.||micrometers|Participants|95% Confidence Interval|Mean
29555|NCT01610557|Primary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to 36 Weeks (Crossover Phase of the Study)|"The primary outcome for 3-months change in BCVA utilized data from Weeks 12, 24 and 36 aggregated in a linear mixed-effects model. This model included adjustments accounting for period (i.e., Weeks 12, 24 and 36), treatment in current period, treatment in prior period, and baseline BCVA to provide the estimated 3-month BCVA change.~Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.||ETDRS letters|Participants|95% Confidence Interval|Mean
29556|NCT01610492|Secondary|Urine BLys Levels as a Ratio to Creatinine|B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS:creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and Week 116/16 week follow-up visit||05/2017||||
29557|NCT01610492|Secondary|Serum BLys Levels|Free BLyS protein is being analyzed using an ELISA. Serum samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and Week 116/16 week follow-up visit||05/2017||||
29558|NCT01610492|Secondary|Change From Baseline in Cytokines/Chemokines|Cytokine/chemokines associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification is being used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Cytokine/chemokine samples are being collected on Day 0 and Weeks 8, 16, 28, 52, 76, and 4 week post last dose. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29559|NCT01610492|Secondary|Change From Baseline in B Cell and T Cell Subpopulations|Blood samples for flow cytometry quantification of peripheral lymphocyte (B cell and T cell) subpopulations and activation markers are being collected on Day 0 and at the Week 8, 16, 28, 4 week post last dose and 6 month post last dose visits. B cell Facs panels are being used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel are being used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 128/6 month post last dose||05/2017||||
29560|NCT01610492|Secondary|Change From Baseline in Urine Membrane Attack Complex (MAC)|Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to 4 week post last dose||05/2017||||
29562|NCT01610492|Secondary|Immunogenicity During the 104-week Treatment Period and up to Week 116/16 Week Follow-up Visit|Immunogenicity samples are being collected pre-dose on Weeks 0, 12, 28, 40, 52, 76 and 4 week post last dose and the 16 week post last dose visit for belimumab immunogenicity assay. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 116/16 week follow-up visit||05/2017||||
29563|NCT01610492|Secondary|Vital Signs Measurements Assessed up to 116/16 Week Follow-up Visit|Vital signs including systolic and diastolic blood pressure, pulse rate and temperature were measured throughout the 104-week treatment period and follow-up. Sitting blood pressure/heart rate and body temperature are being measured pre-dose on dosing days. Blood pressure is being measured on at least 2 clinic visits during the Screening phase or by a 24 h ambulatory blood pressure monitor. Additionally, weight is being measured at all dosing visits prior to dosing and at Week 104. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 116/16 week follow-up visit||05/2017||||
29564|NCT01610492|Secondary|Summary of Urinalysis Parameters Assessed up to Week 116/16 Week Post Last Dose|Urinalysis included pH, glucose, protein, blood and ketones by dipstick, microscopic examination and urine pregnancy assessed up to Week 128/6 month follow-up visit. Urinalysis is done pre-dose during dosing visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 116/16 week follow-up visit||05/2017||||
29565|NCT01610492|Secondary|Summary of Haematology Laboratory Parameters Assessed up to Week 116/16 Week Post Last Dose|Hematology laboratory parameters included platelet count, red blood cells (RBC) count, white blood cell (WBC) count, haemoglobin, haematocrit, neutrophils, lymphocytes, monocytes, eosinophils and basophils assessed up to Week 128/6 month follow-up visit. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 116/16 week follow-up visit||05/2017||||
29566|NCT01610492|Secondary|Summary of Clinical Chemistry Laboratory Parameters Assessed up to Week 116/16 Week Post Last Dose|Clinical chemistry laboratory parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total and direct bilirubin, creatinine, chloride, uric acid, glucose, total carbondioxide (CO2), gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase, total protein, eGFR, cholesterol, inorganic phosphates, magnesium, immunoglobulin (Ig) G, IgA, IgM and lactate dehydrogenase assessed up to Week 128/6 month follow-up visit. IgG is being assessed at Screening, then each dosing visit up to Week 52 and Weeks 60, 68, 76, 84, 92, 100, Week 104/4 week post last dose and 16 week and 6 month follow-up visits. IgA and IgM is being assessed at Screening, and then at Week 0, 28 and at Week 104/4 week post last dose. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 116/16 week follow-up visit||05/2017||||
29567|NCT01610492|Secondary|Summary of Total Amount of Urine Excreted Ae(0-24)|PK parameters from the urine concentration data: urine Ae(0-24) is being assessed. 24 h urine collections for PK analysis are being collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach will be undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis is being conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to 4 week post last dose||05/2017||||
29568|NCT01610492|Secondary|Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2])|The AUC(0-2) is being determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis are being collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to 4 week post last dose||05/2017||||
29569|NCT01610492|Secondary|Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points|Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment of steady state. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to 4 week post last dose||05/2017||||
29570|NCT01610492|Secondary|Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points|The first occurrence of Cmax is being determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters are being calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to 4 week post last dose||05/2017||||
29571|NCT01610492|Secondary|Change From Baseline in SF-36 v2 Quality of Life (QoL) Questionnaire Score|Health-related quality of life is being assessed through participant self-completion of the short form health survey (SF-36 version [v2]), a general health related quality of life metrics. The SF-36 v2 is referred to as a generic measure as it assesses health concepts that represent basic human values that are relevant to everyone’s functional status and wellbeing. SF-36 is being administered prior to any procedures at Screening, Day 0, and Weeks 12, 28, 52, 76 and 104/4 week post last dose. For participants on 12 weekly follow-up, assessment of SF-36 is being conducted at the closest visit to those in the treatment phase. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|From Baseline and up to Week 104/4 week post last dose||05/2017||||
29605|NCT01610167|Primary|Adverse Events.|Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).|Immediately after treatment to 28 days (+/- 2 days) post treatment.|Intent to treat (ITT).||Number of adverse events.|||Number
29572|NCT01610492|Secondary|Summary of Incidence of Oedema by Severity|Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the oedema in participants. Investigators are physically reviewing participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. oedema extending beyond calf) during study. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Screening and up to Week 104/4 week post last dose||05/2017||||
29573|NCT01610492|Secondary|Change From Baseline in Levels of Cholesterol at the Indicated Time Points|Clinical chemistry laboratory parameters included cholesterol which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for cholesterol is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), cholesterol is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29574|NCT01610492|Secondary|Cholesterol at the Indicated Time Points|Clinical chemistry laboratory parameters included cholesterol which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for cholesterol is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), cholesterol is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29575|NCT01610492|Secondary|Change From Baseline in Levels of Serum Albumin at the Indicated Time Points|Clinical chemistry laboratory parameters included serum albumin which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum albumin is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29576|NCT01610492|Secondary|Serum Albumin at the Indicated Time Points|Clinical chemistry laboratory parameters included serum albumin which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum albumin is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29577|NCT01610492|Secondary|Change From Baseline in Serum Creatinine Levels at the Indicated Time Points|Clinical chemistry laboratory parameters included serum creatinine which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum creatinine is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29578|NCT01610492|Secondary|Serum Creatinine Levels at the Indicated Time Points|Clinical chemistry laboratory parameters included serum creatinine which is being assessed from Baseline and up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), serum creatinine is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29579|NCT01610492|Secondary|Change From Baseline in eGFR Levels at the Indicated Time Points|eGFR is being assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), eGFR is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The ratio is defined as the value at the defined time point divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29580|NCT01610492|Secondary|eGFR Levels at the Indicated Time Points|eGFR is being assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values. For the end of therapy (Week 104/4 week post last dose assessment), eGFR is being analyzed at both Weeks 100 and 104 (or last dose and 4 week post last dose visits for participants withdrawing early from study treatment), and the mean is being calculated. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods. Milliliters per minute per 1.73 meter squared (ml/min/1.73m^2).|Baseline and up to Week 104/4 week post last dose||05/2017||||
40532|NCT01450189|Secondary|Number of Partners Reporting for HIV Testing|Number of partners per index reporting for HIV testing at any time during follow-up|52 weeks|||partners per index participant||95% Confidence Interval|Mean
29581|NCT01610492|Secondary|Incidence of Anti-PLA2R Autoantibody Relapse|Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29582|NCT01610492|Secondary|Time to Anti-PLA2R Autoantibody Remission|Time to anti-PLA2R autoantibody remission - full response with antibody undetectable. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29583|NCT01610492|Secondary|Incidence of Full/Partial Remission for Anti-PLA2R Autoantibody|Incidence of anti-PLA2R autoantibody remission: full response is defined as antibody undetectable, partial response is defined as reduction in titres by 50%. For anti PLA2R autoantibody data, log transformation is being applied before the formal analyses. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 Week post last dose||05/2017||||
29584|NCT01610492|Secondary|Incidence of Proteinuria Relapse|Incidence of proteinuria relapse is defined as participants with PCR >350 mg/mmol and an increase of 50% from the lowest remission level, in those participants who had previously achieved any type of remission. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29585|NCT01610492|Secondary|Duration of Complete or Partial Remission|Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15%). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no worsening in renal function (eGFR reduction from Baseline <15%). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/ 4 week post last dose||05/2017||||
29586|NCT01610492|Secondary|Time to Complete or Partial Remission|Time to complete or partial remission and time of proteinuria are being estimated using the Kaplan-Meier method. Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15%). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no worsening in renal function (eGFR reduction from Baseline <15%). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29587|NCT01610492|Secondary|Incidence of Complete or Partial Remission|Complete remission is defined as PCR <30 milligrams per millimoles (mg/mmol) (proteinuria <0.3grams [g]/24 h) with no worsening in renal function (estimated glomerular filtration rate [eGFR] reduction from Baseline <15 percent [%]). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no worsening in renal function (eGFR reduction from Baseline <15%). The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and up to Week 104/4 week post last dose||05/2017||||
29588|NCT01610492|Secondary|Change From Baseline in Urine Levels of Belimumab at the Indicated Time Points|24 h urine samples are being collected for pharmacokinetic analysis of belimumab, after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. Baseline is defined as the Day 0 value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and Weeks 12, 28, 52, 76 and 4 week post last dose||05/2017||||
29589|NCT01610492|Secondary|Change From Baseline in Anti-PLA2R Autoantibody Titres at the Indicated Time Points|PLA2R autoantibody titres in serum are being analyzed by means of a validated anti- PLA2R ELISA from EuroImmun. Anti-PLA2R autoantibody blood samples are being collected at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and 16 week and 6 month follow-up visits. Baseline is defined as the Day 0 value. Ratio is defined as the post-Baseline value divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and Weeks 12, 28, 52, 76 and 104/4 week post last dose||05/2017||||
29590|NCT01610492|Secondary|Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titres at the Indicated Time Points|PLA2R autoantibody titres in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value.|Baseline and Week 28|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||relative units per milliliter (RU/mL)||Geometric Coefficient of Variation|Geometric Mean
29591|NCT01610492|Secondary|Change From Baseline in Proteinuria Levels at the Indicated Time Points|Proteinuria is being assessed at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 36, 44, 52, 60, 68, 76, 84, 92, 100, 104/4 week post last dose and at the 16 week and 6 month follow-up visits. Proteinuria measurements are being based on urinary protein creatinine ratio measurements spot urine samples. For other key time points, Weeks 12, 52, 76 and 4 week post last dose, they are the mean of the PCR from a pre-dose spot urine sample and from a 24 h post-dose or post visit urine collection. Baseline is defined as the mean of the pre and post dosing Day 0 values from 2 consecutive 24 h urine collections. The ratio is defined as the post-Baseline value divided by the Baseline value. The results for this outcome measure will be reported at the end of the study i.e. May 2017, as they were not designed to be reported at interim periods.|Baseline and Weeks 12, 28, 52, 76 and 104/4 week post last dose||05/2017||||
29592|NCT01610492|Secondary|Proteinuria Levels at the Indicated Time Points|Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 h urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the Day 0 value.|Baseline and Week 28|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||milligrams per millimole (mg/mmol)||Geometric Coefficient of Variation|Geometric Mean
29593|NCT01610492|Primary|Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titres at Week 28|PLA2R autoantibody titres in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value. The ratio is defined as the Week 28 value divided by the Baseline value.|Baseline and Week 28|ITT Population. Only those participants available at the indicated time point (Week 28) were analyzed.||Ratio||Geometric Coefficient of Variation|Geometric Mean
29594|NCT01610492|Primary|Change From Baseline in Proteinuria Levels at Week 28|Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value.|Baseline and Week 28|Intent-to-Treat (ITT) Population: all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.||Ratio||Geometric Coefficient of Variation|Geometric Mean
29595|NCT01610453|Secondary|Percentage of Women With Cesarean Section|The percentage of women with cesarean section was compared in cases with occiput posterior position and cases with non occiput posterior position assessed with transabdominal sonography when prolonged labor was diagnosed.|active labor|Fetal head position was assessed successfully using transabdominal ultrasound in 142/150 women. Position could not be diagnosed in eight cases due to shadowing from maternal pelvis in cases at low stations.||percentage of participants in each group|||Number
29596|NCT01610453|Primary|Percentage of Women With Vaginal Deliveries|Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance (HPD) ≤40 mm and angle of progression (AoP) ≥110 degrees were used as cut-off level. HPD was obtained in all 150 cases and AoP was successfully obtained in 145 cases.|active labor|AoP could not be measured in 5 cases because only a part of the symphysis was visualized.||percentage of participants in each group||95% Confidence Interval|Number
29597|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Cardiac Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Cardiac MRI values between 10 to 20 milliseconds (ms) are indicative of moderate cardiac iron deposition associated with declining left ventricular ejection fraction and arrhythmias while values <10 ms are indicative of deposition sufficient to risk cardiac decompensation and associated with overt heart failure and mortality.|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||ms||Standard Deviation|Mean
29598|NCT01610297|Secondary|The Percentage of Patients Reaching Serum Ferritin Levels Lower Than 500 μg/L|Serum Ferritin values between 1000-2500 μg/L are indicative of mild to moderate iron overload while values >2500 μg/L are indicative of severe iron overload and levels constantly higher than 2500 μg/L has been shown to to increase the risk of cardiac complications and endocrine disease. Maintaining levels <1000 μg/L is associated with increased survival and less morbidity.|Week 28 and Week 52|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||Percentage of Patients|||Number
29599|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Liver Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Liver Iron Concentration (LIC) values between 3 and 7 mg Fe / g dry weight are indicative of mild iron deposition, while values between 7 and 15 mg Fe / g dry weight are indicative of moderate iron deposition which have been associated with liver disease. Values >15 mg Fe/g dry weight are indicative of severe iron deposition which is associated with progressive liver fibrosis, increased morbidity and mortality|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||mg Fe/g dry liver weight||Standard Deviation|Mean
29600|NCT01610297|Secondary|Change in Serum Ferritin Level.|Blood samples were collected and serum levels were assessed at study baseline (BL) and at 12 months.|Baseline, 12 Months|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.||ng/mL||Standard Deviation|Mean
29601|NCT01610297|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths as a Measure of Safety and Tolerability|To determine the safety; incidence, type and severity of adverse events including renal, hepatic, biochemistry and hematologic parameters of deferasirox in the treatment of iron overload after hematopoietic stem cell transplantation (HSCT) in patients with beta-thalassemia major in 12 months period|12 months|The Safety Set (SS) includes all included patients who were included in the study. All statistical analyses of safety and tolerability will be done in the SS.||Participants|||Number
29602|NCT01610167|Secondary|Extended Sensitivity Relief. Air Blast Sensitivity.|Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.|28 days (+/- 2 days) post treatment.|||units on a scale||Standard Deviation|Mean
29603|NCT01610167|Primary|Immediate Sensitivity Relief. Air Blast Sensitivity.|Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.|Immediately after treatment.|||units on a scale||Standard Deviation|Mean
29604|NCT01610167|Secondary|Extended Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination."|28 days (+/- 2 days) post treatment.|Intent to treat (ITT).||grams||Standard Deviation|Mean
29606|NCT01610167|Primary|Immediate Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment."|Immediately after treatment.|Intention to treat (ITT).||grams||Standard Deviation|Mean
29607|NCT01610076|Secondary|Willingness to Recommend Video to Other Patients|"Participants were surveyed, Would you recommend this video to other patients? Three options were provided:~Definitely recommend Probably recommend Do not recommend"|immediately after intervention|||participants|||Number
29608|NCT01610076|Secondary|Perception of Utility of Video|"Participants were surveyed, How helpful was this video in helping you understand your options? There possible answers were provided:~Very helpful Somewhat helpful Not helpful"|immediately after intervention|||participants|||Number
29609|NCT01610076|Secondary|Participant Reported Comfort With Video Intervention|"Patient's were surveyed about How comfortable were you watching the video?"|immediately after intervention|Patient's surveyed about||participants|||Number
29610|NCT01610076|Primary|12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)|"12 question (question 4 has 4 sub-questions) survey previously validated to determine knowledge level about resuscitation status with total score on the scale of 0-15. Possible scores ranged from 0 to 15, with higher scores representing increased medical knowledge.~The CPR knowledge survey assesses a participants basic understanding of cardiopulmonary resuscitation (CPR). The survey consisted of 12 questions with one point being awarded for each correct response. Question four had a total of four possible correct answers. Thus the scores on the scale of 0-15 points is designed, with higher scores representing increased knowledge."|after admission to ICU, approx one hour|||points||Inter-Quartile Range|Median
29611|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Liters||Standard Deviation|Mean
29612|NCT01610037|Secondary|Time to Premature Discontinuation|Time to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment early. The range of the ‘time to treatment discontinuation’ varied from 5-407 days in the Tiotropium group. Hence the model estimated lower limit of the median time to treatment discontinuation is greater than the scheduled treatment period of 52 weeks.|Time varied from 5 - 407 days|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
29613|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Liters||Standard Deviation|Mean
29614|NCT01610037|Secondary|Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.|A day able to perform usual daily activities’ is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Percentage of days||Standard Deviation|Mean
29615|NCT01610037|Secondary|Change From Baseline in Percentage of no Daytime Symptoms|A day with ‘no daytime symptoms’ is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx. 8 am to 8 pm).|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Percentage of days||Standard Deviation|Mean
29616|NCT01610037|Secondary|Change From Baseline in Percentage of Nights With ‘no Nighttime Awakenings|A night with ‘no nighttime awakenings’ is defined from diary data as any night where the patient did not wake up due to symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Percentage of nights||Standard Deviation|Mean
29617|NCT01610037|Secondary|Change From Baseline in Daily, Morning and Evening Symptom Scores|Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease. The mean daily total symptom score, the mean daytime total symptom score and the mean nighttime total symptom score were calculated for each patient over 52 weeks. Diary data recorded during the 14 day run-in period were used to calculate the baseline.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Score||Standard Deviation|Mean
29618|NCT01610037|Secondary|Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)|"The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score will be calculated for each of these three subscales and a Total score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|Measurment at day 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Score||Standard Deviation|Mean
29619|NCT01610037|Secondary|Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|Day 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who eceived at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum||Liters||Standard Error|Least Squares Mean
29620|NCT01610037|Secondary|Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE|The composite endpoint included all deaths and all serious CCV events, including MACE and events which were not considered MACE. A rigorous post hoc analysis was done on composite endpoint of CV deaths and major adverse cardiovascular events (MACE). The patients with an event in the analysis were those who had at least one of the 2 events namely, CV deaths and MACE, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.||Percentage of participants|||Number
29621|NCT01610037|Secondary|Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.|The endpoint of all-cause mortality and serious CCV events (composite) was chosen to further characterize any discernible risks. The patients with an event in the analysis were those who had at least one of the 2 events namely, all-cause mortality and serious CCV, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.||Percentage of participants|||Number
29622|NCT01610037|Primary|Number of Patients With Serious Adverse Events|The overall rate of serious adverse events reported from initiation through 30 days post last dose.|Week 52|The safety set included all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. A patient who had no adverse events also constitutes a safety assessment.||Participants|||Number
29623|NCT01610011|Primary|Brain Glycine Increments After Oral Glycine Administration Measured With MRS as Glycine/Total Creatine, Normalized to the Glycine Dose Administered (g/kg).|Brain and plasma glycine levels are measured with proton magnetic resonance spectroscopy at 4T and analytically, respectively. Because glycine doses were limited to 30 g to avoid nausea and vomiting, some subjects with higher weights were administered lower doses per body weight of glycine (g/kg). Therefore, we corrected MRS data by the actual glycine dose administered (g/kg) to account for dosing differences.|For up to 2 hours|Subjects completing the magnetic resonance spectroscopy study.||Percent brain glycine/creatine increase|Participants|Standard Error|Mean
29624|NCT01609582|Secondary|Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke.|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.||days||95% Confidence Interval|Median
29625|NCT01609582|Primary|Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.||days||95% Confidence Interval|Median
29626|NCT01609543|Secondary|Percentage of Participants Who Were Alive at 1 Year||1 Year (12 months)|ITT population. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.||Percentage of Participants|||Number
29627|NCT01609543|Secondary|Percentage of Participants With Best Overall Response (BOR)|BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to progressive disease or death (up to 34 months)|ITT population.||Percentage of Participants|||Number
29628|NCT01609543|Primary|Progression-Free Survival (PFS)|PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.|Baseline to progressive disease or death (up to 34 months)|ITT population.||Months||95% Confidence Interval|Median
29629|NCT01609478|Secondary|Plasma Indacaterol Concentrations at Day 1 and Day 14|Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup|Day 1 and Day 14|Pharmacokinetic (PK) profiling subgroup included all randomized patients who consented to participate in the additional PK assessment.||pg/ml||Standard Deviation|Mean
29630|NCT01609478|Secondary|Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period|Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||milligrams (mg)||Standard Deviation|Mean
29631|NCT01609478|Secondary|The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period|The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||percentage of participants|||Number
29632|NCT01609478|Secondary|Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period|Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||days||95% Confidence Interval|Median
29633|NCT01609478|Secondary|The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||percentage of participants|||Number
29634|NCT01609478|Secondary|Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||days||Standard Deviation|Mean
29635|NCT01609478|Secondary|The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||# of exacerbations||95% Confidence Interval|Number
29636|NCT01609478|Secondary|Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||weeks||95% Confidence Interval|Median
29637|NCT01609478|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|4 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Units on a Scale||Standard Error|Least Squares Mean
29638|NCT01609478|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment|Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||number of puffs||Standard Deviation|Least Squares Mean
29639|NCT01609478|Secondary|Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.|PEFR is measured with portable spirometer by participants every morning and evening at home.|baseline, 4weeks, 8 weeks and 12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters/second||Standard Error|Least Squares Mean
29640|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|after 4 weeks (Day 29) and after 8 weeks (Day 57)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||units on a scale||Standard Error|Least Squares Mean
29641|NCT01609478|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)|Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.|Day 1, 2 weeks (Day 14), 12 weeks (Day 84)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters||Standard Error|Least Squares Mean
29642|NCT01609478|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)|Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.|Day 1, 2 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Liters||Standard Error|Least Squares Mean
29643|NCT01609478|Secondary|Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters/second||Standard Error|Least Squares Mean
29644|NCT01609478|Secondary|Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||ratio||Standard Error|Least Squares Mean
29645|NCT01609478|Secondary|Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points|Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||liters||Standard Error|Least Squares Mean
29646|NCT01609478|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.|Day 15, Day 29 and Day 57|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Liters||Standard Error|Least Squares Mean
29647|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)|The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|aftert 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Units on a Scale||Standard Error|Least Squares Mean
29648|NCT01609478|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)|after 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.||Liters||Standard Error|Least Squares Mean
29649|NCT01609257|Secondary|Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)|Unsolicited AEs indicates any and all AEs that occurred other than those that were solicited.|Vaccination Stage: Initial vaccination until 28 days after second vaccination; or Challenge Stage: the day of challenge until 60 days after challenge|MITT population included all participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
29650|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
29651|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29652|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
29653|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
29654|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GI.1 VLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29655|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMFR From Baseline|HBGA (PGM) is Histoblood Group Antigen (Pig Gastric Mucin).|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
29656|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
29657|NCT01609257|Secondary|Percentage of Participant With ELISA IgA- Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29658|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
29659|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
29660|NCT01609257|Secondary|Percentage of Participants With ELISA IgA- Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29661|NCT01609257|Secondary|ELISA Immunoglobulin A (IgA)- Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
29663|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29664|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
29665|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||titer||95% Confidence Interval|Geometric Mean
29666|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29667|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||ratio||95% Confidence Interval|Geometric Mean
29668|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HGBA Antibodies Prior to Challenge Associated With Protection From GII.4 Infection|Percentage of placebo subjects HBGA seropositive pre-challenge by infection status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants|||Number
29669|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HBGA Antibodies Prior to Challenge Associated With Protection From GII.4 Illness|Percentage of placebo subjects HBGA seropositive pre-challenge by illness status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants|||Number
29670|NCT01609257|Secondary|Percentage of Participants With GII.4 Seroresponse Rate (4-fold Rise) From Pre-challenge Day 0 to Post-Challenge Day 30|Seroresponse was a 4-fold increase in IgG ELISA anti-GII.4 norovirus P particle antibody titer from pre-challenge to post-challenge.|Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.||percentage of participants||95% Confidence Interval|Number
29671|NCT01609257|Secondary|Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase||Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants with at least one dose of study drug, challenge stage with data available for analysis.||percentage of participants|||Number
29672|NCT01609257|Secondary|Duration of Viral AGE Due to GII.4 Strain During the Inpatient Phase|Duration of symptoms was determined by a blinded committee review of each participant's symptoms.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.||hours||Full Range|Median
29673|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase|Score 1 was based on a subset of symptoms including: elevated oral temperature, myalgia, nausea, abdominal cramps, bloating, diarrhea, and vomiting. Score 2 was based on all Score 1 symptoms plus fatigue/malaise, chills, and loss of appetite. Total Score 1=0 to 20 and Total Score 2=0 to 29. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.||score on a scale||Standard Deviation|Mean
29674|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Modified Vesikari Scoring System During the Inpatient Phase|Vesikari Scoring System assesses the following symptoms: duration of diarrhea (days), maximum number of diarrheal stools/24 hours, duration of vomiting (days), maximum number of vomiting episodes/24 hours, fever and dehydration. Since the typical inpatient phase was four days in length, the duration of diarrhea scoring was modified to fit this time frame. Modified Vesikari Scale Total Score=0 to 17. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.||score on a scale||Standard Deviation|Mean
29675|NCT01609257|Secondary|Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool||Pre Challenge to 30 Days Post Challenge|MITT population included all participants who received at least one dose of study drug, Challenge stage.||percentage of participants|||Number
29676|NCT01609257|Primary|Percentage of Participants With Serious Adverse Events (SAEs) 365 Days Following the Last Study Vaccination|A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|365 Days Following Dose 2 (Up to 393 days)|MITT population included all participants who received at least one dose of study drug.||percentage of participants|||Number
29677|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 2|Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.||percentage of particpants||95% Confidence Interval|Number
29864|NCT01606228|Secondary|Patient Satisfaction With Paliperidone Treatment|Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).|90 days|Per Protocol (PP) population||participants|||Number
29678|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 1|Systemic signs or symptoms included: elevated daily oral temperature (fever), headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 1|MITT included all participants who received at least one dose of study drug. Data is missing for 2 participants.||percentage of particpants||95% Confidence Interval|Number
29679|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 2|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.||percentage of participants||95% Confidence Interval|Number
29680|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 1|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 1|MITT population included all participants who received at least one dose of study drug. Data is missing for 2 participants.||percentage of participants||95% Confidence Interval|Number
29681|NCT01609257|Primary|Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer|Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR >400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Modified intent-to-treat population (mITT) included all participants who received at least one dose of study drug, challenge stage.||percentage of participants|||Number
29682|NCT01609062|Secondary|Adolescent Pediatric Pain Tool (APPT) - Pain Intensity|"The APPT is a validated, multidimensional tool to evaluate pain in children, adolescents, and young adults. The complete APPT is measured in three parts - Part 1 of the APPT scale determines the subject's pain locations using a body template. Part 2 of the APPT scale determines the intensity of the pain using a 10 cm visual analog scale (VAS) with the lowest point of the scale (0) labeled No Pain and the highest point on the scale (10) labeled Worst Possible Pain. Intermediate regions of the sale were labeled with 3 intermediate descriptors (Little Pain, Medium Pain, and Large Pain). Part 3 of the APPT scale characterizes the pain by tracking the number and percentage of words selected by subjects to describe their pain from a total of 57 choices. Part 2 corresponds most closely to other typically used pain scales (based on VAS) and for this reason the results from Part 2 are presented here.~Change from baseline to Week 12, 24, and 52 in pain intensity."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat||units on a scale||Standard Deviation|Mean
29683|NCT01609062|Secondary|Muscle Strength Testing (MST) - Elbow Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST elbow flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
29684|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST knee flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
29685|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Extension Test|Change from baseline to Week 25 and 52 as measured by the peak force in MST knee extension test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
29686|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Aerobic Efficiency|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET Aerobic Efficiency (ml/watt).~Note that decline in Aerobic Efficiency translate into an improvement"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
29687|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - O2 Pulse|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET O2 pulse (ml/beat)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
29688|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Peak Workload|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET Peak workload (watt)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
29689|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Duration of Exercise|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Change from baseline to Week 25 and 52 as measured by the CPET Duration of Exercise (min)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET||Percent Change||Standard Deviation|Mean
30667|NCT01594970|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
29691|NCT01609062|Secondary|Respiratory Function Test (MVV and FVC)|"Respiratory Function was assessed by spirometry in accordance with American Thoracic Society standards.~Percent change from baseline to Week 12, 24, and 52 as measured by Maximum Voluntary Ventilation (MVV, L/min) Percent change from baseline to Week 12, 24, and 52 as measured by Forced Vital Capacity (FVC, L)"|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set||Percent Change||Standard Deviation|Mean
29692|NCT01609062|Secondary|3-minute Stair Climb Test (3MSCT)|Change from baseline to Week 12, 24, and 52 as measured in speed (stairs/min) in 3MSCT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set||stairs/min||Standard Deviation|Mean
29693|NCT01609062|Secondary|6-minute Walk Test (6MWT)|Change from baseline to Week 12, 24, and 52 as measured in distance walked (meters) in 6MWT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set||meters||Standard Deviation|Mean
29694|NCT01609062|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).~The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 192 weeks or ETV (early termination visit)|The primary outcome measure data is presented in more detail under the Adverse Events section.||participants|||Number
29695|NCT01609010|Secondary|Overall Survival|The median time, in months, from randomization to OS event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||months||Full Range|Median
29696|NCT01609010|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|An overall survival event was defined as death due to any cause.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
29697|NCT01609010|Secondary|Time to Disease Progression|The median time, in months, from randomization to disease progression event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||months||95% Confidence Interval|Median
29698|NCT01609010|Secondary|Disease Progression - Percentage of Participants With an Event|A disease progression event was defined as tumor progression or death due to any cause (or a censored observation).|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
29699|NCT01609010|Secondary|Duration of Response|The median time, in months, from the date of the first observation of CR, CRu, or PR and the date of progressive disease (PD), censored observation, or death due to any cause. PD was defined as an increase of >50% compared to BL in the sum of the product of the two largest perpendicular parameters of measurable lymphoma, or the occurrence of new lesions. One month=30.4 days. Response duration was calculated amongst responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population; n=number of participants assessed for the specified parameter at a given visit. Only participants with a response (CR+CRu+PR, CR+CRu, or CR only) were included in the analysis.||months||95% Confidence Interval|Median
29700|NCT01609010|Secondary|Duration of Response - Percentage of Participants With an Event|Response duration was defined as the period between the date for first observation of CR, CRu or PR and the date of progressive disease (PD), censored observation or death of any cause. Response duration was also assessed for response defined as CR only. Response duration was calculated among responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
29701|NCT01609010|Secondary|Percentage of Participants Achieving CR or CRu|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes >1 cm or nodes >1.5 cm observed in CATscan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate.|Weeks 10 and 16|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants||95% Confidence Interval|Number
29702|NCT01609010|Secondary|Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes greater than (>) 1 centimeter (cm) or nodes >1.5 cm observed in computerized axial tomography (CAT) scan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate. PR was defined as a decrease of greater than or equal to (≥) 50 percent (%) compared with the BL value in the sum of the products of the two largest perpendicular diameters in all measurable and evaluable lesions; and a ≥50% reduction of the size from BL if hepato-splenomegaly was present.|Weeks 10 and 16|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.||percentage of participants||95% Confidence Interval|Number
29703|NCT01609010|Primary|Treatment Failure - Time to Event|The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||months||95% Confidence Interval|Median
29704|NCT01609010|Primary|Treatment Failure - Percentage of Participants With an Event|Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment.|Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population||percentage of participants|||Number
29705|NCT01608971|Primary|Rotem MCF Fibtem and MCF Intem|The following parameters of the INTEM test will be analyzed: MCF [mm] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF [mm] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.|15 Minutes after protamine infusion|Patients of both groups||mm||Inter-Quartile Range|Median
29706|NCT01608971|Secondary|12 h Postoperative Blood Loss|The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.|15 min after protamine administration until 12 hours postoperatively|||ml/12 hour||Inter-Quartile Range|Median
29707|NCT01608971|Secondary|Transfusion of Blood Products and Coagulation Factors|The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .|From protamine administration until 12 h after surgery|Transfusion of RBC||percentage of patients transfused|||Number
29708|NCT01608971|Primary|INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer|The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT [seconds](coagulation time), CFT [seconds] (clot formation time) and the CT [seconds] of the HEPTEM test which is non sensitive for residual heparine.|Tests will be measured 15 minutes after Protamine infusion|Rotem INTEM CT, CFT, MCF and FIBTEM MCF and Heptem CT||seconds||Inter-Quartile Range|Median
29709|NCT01608815|Secondary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site (children): Pain Incapacitating, unable to perform usual activities; Erythema and Swelling ≥ 50 mm; Grade 3 injection site (adults and adolescents): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 systemic reactions: Fever, ≥39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
29710|NCT01608815|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titer Ratios were assessed in the Immunology Analysis Set.||Ratio||95% Confidence Interval|Geometric Mean
29711|NCT01608815|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Titers were assessed in the Immunology Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
29712|NCT01608815|Primary|Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine|Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|Vi antibody titers were assessed in the Immunology Analysis Set.||Participants|||Number
29713|NCT01608724|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)||Week 24|Patients who participated in standard noodle test in the per-protocoal analysis set (PPS), which included patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||mmol/L||Standard Error|Mean
29714|NCT01608724|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)||Weeks 6, 12, 18, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||mmol/L||Standard Error|Mean
29715|NCT01608724|Secondary|Proportion (%) of Patients Achieving HbA1c <7%||Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||Percentage|||Number
29716|NCT01608724|Primary|Absolute Change From Baseline in Haemoglobin A1c (HbA1c)|Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.|Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.||(%)||Standard Error|Mean
29717|NCT01608672|Secondary|Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire|"Physicians rated their overall satisfaction with BOTOX® treatment by answering the question on the Physician Reported Overall Satisfaction of Effectiveness Questionnaire: You have treated this patient with BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants where the physician answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.||Percentage of participants|||Number
29718|NCT01608672|Secondary|Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire|"Participants rated their overall satisfaction with BOTOX® treatment by answering the question on the Patient Reported Overall Satisfaction of Effectiveness Questionnaire: You have received BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants who answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.||Percentage of participants|||Number
29719|NCT01608672|Primary|Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)|Participants assessed their overall satisfaction with their glabellar lines by answering FLSQ Question 5: “How satisfied are you with the effect your treatment had on your facial lines?” using a 5-point scale where: -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.||Percentage of participants|||Number
29720|NCT01608659|Secondary|Percent of Subjects Reporting Satisfaction With Treatment Effects|Percent of subjects reporting satisfaction with treatment effects per chart notes.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.||Percentage of Subjects||Standard Deviation|Mean
29721|NCT01608659|Secondary|Inter-Injection Interval Duration of Each Treatment Period|Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.||Days||Full Range|Median
29723|NCT01608308|Secondary|Postoperative Vital Sign (Respiratory Rate)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||breaths per minute||Standard Deviation|Mean
29724|NCT01608308|Secondary|Postoperative Vital Sign (Temperature)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||Fahrenheit||Standard Deviation|Mean
29725|NCT01608308|Secondary|Postoperative Vital Sign (Pulse)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||beats per minute||Standard Deviation|Mean
29726|NCT01608308|Secondary|Postoperative Vital Sign (Diastolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||mmHg||Standard Deviation|Mean
29727|NCT01608308|Secondary|Postoperative Vital Sign (Systolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||mmHg||Standard Deviation|Mean
29728|NCT01608308|Secondary|Number of Participants Who Experienced Postoperative Morbidity (Nausea)|Post-operative nausea will be monitored and measured through direct observation and nursing clinical record|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||participants|||Number
29729|NCT01608308|Secondary|Number of Participants Who Received Intraoperative Supplemental Fentanyl|Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||participants|||Number
29730|NCT01608308|Secondary|Total Doses of Postoperative Opiate (Morphine) Use|The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)|||doses||Inter-Quartile Range|Median
29731|NCT01608308|Primary|Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale|VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain).|15 minutes and 120 minutes Post-Operatively|At the 15 minute time point, data was obtained for 24 participants in the acetaminophen group and 26 participants in the control group. For the 120 minute time point, data was obtained for 7 participants in the acetaminophen group and 11 participants in the control group.||units on a scale||Inter-Quartile Range|Median
29732|NCT01608100|Primary|Clinical Performance- Positive Predictive Value (PPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||%MI,TnI >cutoff vs all TnI > cutoff||95% Confidence Interval|Number
29733|NCT01608100|Primary|Clinical Performance- Negative Predictive Value (NPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||%nonMI,TnI</=cutoff vs all TnI</=cutoff||95% Confidence Interval|Number
29734|NCT01608100|Primary|Clinical Performance- Specificity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||% nonMI with TnI </= cutoff vs all nonMI||95% Confidence Interval|Number
29735|NCT01608100|Primary|Clinical Performance- Sensitivity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||percentage MI withTnI >cutoff vs all MI||95% Confidence Interval|Number
29758|NCT01607853|Secondary|Change in Total Clinical Score at Day 18 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 18|||units on a scale||Standard Deviation|Mean
29736|NCT01608100|Secondary|Prognosis|Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses.|30-day and 90-day follow-up|30 Day and 90-day prognosis (Kaplan Meier analysis) and Hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) are summarized. *Censored is defined as the subject has not experienced ACM/MACE at the indicated follow-up time point.||participants|||Number
29737|NCT01608100|Primary|Clinical Performance - Area Under the Curve|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.||Probability||95% Confidence Interval|Number
29738|NCT01607853|Secondary|Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22||Baseline to day 22|||millimeters||Standard Deviation|Mean
29739|NCT01607853|Secondary|Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.||Baseline to day 22|||millimeters||Standard Deviation|Mean
29740|NCT01607853|Secondary|Change From Baseline in Scaling at Day 22|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22|||units on a scale||Standard Deviation|Mean
29741|NCT01607853|Secondary|Change From Baseline in Scaling at Day 18|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18|||units on a scale||Standard Deviation|Mean
29742|NCT01607853|Secondary|Change From Baseline in Scaling at Day 15|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15|||units on a scale||Standard Deviation|Mean
29743|NCT01607853|Secondary|Change From Baseline in Scaling at Day 11|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11|||units on a scale||Standard Deviation|Mean
29744|NCT01607853|Secondary|Change From Baseline in Scaling at Day 8|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8|||units on a scale||Standard Deviation|Mean
29745|NCT01607853|Secondary|Change From Baseline in Scaling at Day 4|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4|||units on a scale||Standard Deviation|Mean
29746|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 22|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22|||units on a scale||Standard Deviation|Mean
29747|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 18|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18|||units on a scale||Standard Deviation|Mean
29748|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 15|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15|||units on a scale||Standard Deviation|Mean
29749|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 11|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11|||units on a scale||Standard Deviation|Mean
29750|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 8|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8|||units on a scale||Standard Deviation|Mean
29751|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 4|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4|||units on a scale||Standard Deviation|Mean
29752|NCT01607853|Secondary|Change From Baseline in Erythema at Day 22|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22|||units on a scale||Standard Deviation|Mean
29753|NCT01607853|Secondary|Change From Baseline in Erythema at Day 18|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18|||units on a scale||Standard Deviation|Mean
29754|NCT01607853|Secondary|Change From Baseline in Erythema at Day 15|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15|||units on a scale||Standard Deviation|Mean
29755|NCT01607853|Secondary|Change From Baseline in Erythema at Day 11|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11|||units on a scale||Standard Deviation|Mean
29756|NCT01607853|Secondary|Change From Baseline in Erythema at Day 8.|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8|||units on a scale||Standard Deviation|Mean
29757|NCT01607853|Secondary|Change From Baseline in Erythema at Day 4.|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4|||units on a scale||Standard Deviation|Mean
29759|NCT01607853|Secondary|Change in Total Clinical Score at Day 15 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score.|Baseline to day 15|||units on a scale||Standard Deviation|Mean
29760|NCT01607853|Secondary|Change in Total Clinical Score at Day 11 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 11|||units on a scale||Standard Deviation|Mean
29761|NCT01607853|Secondary|Change in Total Clinical Score at Day 8 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 8|||units on a scale||Standard Deviation|Mean
29762|NCT01607853|Secondary|Change in Total Clinical Score at Day 4 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 4|||units on a scale||Standard Deviation|Mean
29763|NCT01607853|Primary|Change in Total Clinical Score From Baseline to Day 22|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score|baseline to day 22|||units on a scale||Standard Deviation|Mean
29764|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Up to 6 years|FAS was defined as those who had a record of either CGI-I or CGI-S.||Participants|||Number
29765|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Start of administration|FAS was defined as those who had a record of either CGI-I or CGI-S.||Participants|||Number
29766|NCT01607593|Primary|Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation|Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse.|Up to 6 years|Full analysis set (FAS) was defined as those who had a record of either CGI-I or Clinical Global Impression of Severity (CGI-S).||Participants|||Number
29767|NCT01607476|Primary|Global Distribution of F18 Flutemetamol in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.~The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug|||standard uptake value ratio||Standard Deviation|Mean
29768|NCT01607476|Primary|Global Distribution of C11 PiB in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.~The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug|||standard uptake value ratio||Standard Deviation|Mean
29769|NCT01607450|Secondary|GLP-1 Concentrations|Achieved GLP-1 concentrations at the end of the 12 hour treatment exposure|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed||pmol/L||Standard Deviation|Mean
29770|NCT01607450|Secondary|Cardiac Index|Impedance cardiography-derived measurement of cardiac index, assessed following 12 hour exposure to treatment condition concurrent with the PET measurements.|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed||L/min/m^2||Standard Deviation|Mean
29771|NCT01607450|Secondary|Myocardial Total Oxidation Rate|MVO2 derived from acetate kinetics|After 12 hours of GLP-1 exposure|||ml/min/100g||Standard Deviation|Mean
29772|NCT01607450|Secondary|Myocardial Blood Flow|Myocardial perfusion derived from acetate kinetics|After 12 hours of GLP-1 exposure|||ml/min/100g||Standard Deviation|Mean
29773|NCT01607450|Primary|Myocardial Glucose Uptake.|Myocardial glucose uptake measured using 18FDG PET, quantified using a 3-compartment model with a lumped constant of 1.0.|After 12 hours of glucagon-like peptide 1 (GLP-1) exposure|||umol/min/100g||Standard Deviation|Mean
29774|NCT01607411|Secondary|Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens||μg*F/cm^2||Standard Error|Mean
29775|NCT01607411|Secondary|Percent Net Acid Resistance (%NAR) of Enamel Specimens|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.||%NAR||Standard Error|Mean
29776|NCT01607411|Secondary|%SMHR of Enamel Specimens Exposed to Test Treatments|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.||%SMHR||Standard Error|Mean
29777|NCT01607411|Primary|Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.||%SMHR||Standard Error|Mean
29778|NCT01607398|Secondary|Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period|The occurrence of a COPD exacerbation was assessed on each day of evaluation during the treatment period per the defined severity classifications. COPD exacerbations were classified based on severity as a mild exacerbation (exacerbation of COPD symptoms were manageable by the participant, not requiring systemic corticosteroid or antimicrobial therapy), a moderate exacerbation (exacerbation of COPD symptoms required systemic corticosteroid or antimicrobial therapy), or a severe exacerbation (exacerbation of COPD symptoms required hospitalization). The number of participants who experienced 0, 1, 2, and >=3 exacerbation(s) was summarized.|From Baseline up to Week 12|Per Protocol Population||Participants|||Number
29779|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8; each question scored from 0 to 5) designed to assess the health status of participants with COPD. The total score is calculated as the sum of the scores from Questions 1 to 8, for a range of possible scores of 0 to 40. A higher total score represents a lower quality of life, and vice versa. Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29780|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 8, participants were asked to rate how much energy they have on a scale of 0 to 5: 0, “I have lots of energy”; 5, “I have no energy at all.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29781|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 7, participants were asked to rate how soundly they sleep on a scale of 0 to 5: 0, “I sleep soundly”; 5, “I don't sleep soundly because of my lung condition.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29782|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 6, participants were asked to rate how confident they are leaving home despite their lung condition on a scale of 0 to 5: 0, “I am confident leaving my home despite my lung condition”; 5, “I am not at all confident leaving my home because of my lung condition.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29783|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 5, participants were asked to rate how limited they are in doing activities at home on a scale of 0 to 5: 0, “I am not limited doing any activities at home”; 5, “I am very limited doing activities at home.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29784|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 4, participants were asked to rate how breathless they feel when walking up a flight of stairs or a hill on a scale of 0 to 5: 0, “When I walk up a hill or one flight of stairs I am not breathless”; 5, “When I walk up a hill or one flight of stairs I am very breathless.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29785|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 3, participants were asked to rate how tight their chest feels on a scale of 0 to 5: 0, “My chest does not feel tight at all”; 5, “My chest feels very tight.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29786|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 2, participants were asked to rate the amount of phlegm (mucus) in their chest on a scale of 0 to 5: 0, “I have no phlegm (mucus) in my chest at all”; 5, “My chest is completely full of phlegm (mucus).” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29787|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 1, participants were asked to rate how much they cough on a scale of 0 to 5: 0, I never cough; 5, I cough all the time. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population||Scores on a scale||Standard Deviation|Mean
29788|NCT01607398|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Respiratory function tests were performed for the measurement of FEV1 and FVC at Baseline and at Week 12. The values were measured at 15 to 60 minutes following the use of a pressurized metered-dose inhaler. Three technically acceptable values were obtained, and the highest value was recorded. Change from Baseline in FEV1 and FVC was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population||Liters (L)||Inter-Quartile Range|Median
29789|NCT01607398|Secondary|Change From Baseline in Fibrinogen Levels in Serum at Week 12|Per Protocol Amendment 4, the measurement of fibrinogen levels in serum was removed from the analysis plan because fibrinogen levels were found to be too low and too difficult to measure.|Baseline and Week 12||||||
29790|NCT01607398|Secondary|Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of hsCRP, SP-D, and CC16 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in hsCRP, SP-D, and CC16 was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population||ng/mL||Inter-Quartile Range|Median
29791|NCT01607398|Secondary|Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of IL-6 and IL-8 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in IL-6 and IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population||pg/mL||Inter-Quartile Range|Median
29792|NCT01607398|Secondary|Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of MPO and SP-D in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in MPO and SP-D levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.||ng/mL||Inter-Quartile Range|Median
29793|NCT01607398|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12|Data cannot be reported because hsCRP was under the lower limit of detection in all samples.|Baseline and Week 12||||||
29794|NCT01607398|Secondary|Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of IL-8 in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.||Picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
29795|NCT01607398|Secondary|Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12|INF-gamma-positive cells and perforin-positive cells were not detected in samples collected in this study due to the conditions of the samples and/or antibodies. No re-assays were performed, “no result”/”no data” was entered into the case report forms, and no statistical analysis or data summarization was performed.|Baseline and Week 12||||||
29811|NCT01607112|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
29796|NCT01607398|Secondary|Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. All inflammatory cells in induced sputum were counted with the use of a cytological specimen of cells in the induced sputum. Change from Baseline in all inflammatory cell count was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
29797|NCT01607398|Primary|Change From Baseline in Neutrophil Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).|Baseline and Week 12|Per Protocol Population: all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. Only those participants available at the specified time points were analyzed.||ratio (%)||Inter-Quartile Range|Median
29798|NCT01607320|Secondary|Ovulation|If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.|Cycle day 22-24||||||
29799|NCT01607320|Primary|Pregnancy|Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.|4 months|The study was randomized between the two treatments and was never unblinded, therefore randomization is unknown|||||
29800|NCT01607203|Secondary|Patients With Cryopreserved Embryos||4 weeks|||patients with cryopreserved embryos|||Number
29801|NCT01607203|Secondary|Pregnancy Rate|the number of pregnancies obtained, wich still is the most important issue for the patients|12 weeks|||pregnancies|||Number
29802|NCT01607203|Primary|MII Oocytes|the number of mature oocytes retrieved|3 weeks|||cumulus oocyte complex||Standard Deviation|Mean
29803|NCT01607112|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-21)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
29804|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day follow-up period (Days 0-20) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
29805|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.~Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C"|During the 4-day follow-up period (Day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Subjects|||Number
29806|NCT01607112|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Days||Full Range|Median
29807|NCT01607112|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Day 0-Day 3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented.||Subjects|||Number
29808|NCT01607112|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.||Days||Full Range|Median
29809|NCT01607112|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
29810|NCT01607112|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
30716|NCT01593722|Primary|The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment.||7 days|||percentage of baseline||Full Range|Geometric Mean
29812|NCT01607112|Secondary|Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
29813|NCT01607112|Secondary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
29814|NCT01607112|Secondary|Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
29815|NCT01607112|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
29816|NCT01607112|Primary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
29817|NCT01607112|Primary|Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||Titer||95% Confidence Interval|Geometric Mean
29818|NCT01606800|Primary|Number of Participants Achieving Sustained Virologic Response (SVR)|SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.|At 24 weeks after the completion of therapy (up to 72 weeks)|All Treated Population, which included all participants who received at least one dose of study medication after RVR.||Participants|||Number
29819|NCT01606748|Primary|PK: Dose Normalized AUC(0-∞) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
29820|NCT01606748|Primary|PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
29821|NCT01606748|Primary|PK: Dose-Normalized AUC(0-5) of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
29822|NCT01606748|Secondary|PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
29823|NCT01606748|Primary|PK: Dose-Normalized AUC(0-24) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
29824|NCT01606748|Secondary|PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
29857|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64|The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.|Day 64|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
40747|NCT01445951|Other Pre-specified|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/Subject-Month|||Number
29825|NCT01606748|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 14 Months)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
29826|NCT01606748|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline through, 30-Day Follow-Up|All participants who received at least one dose of study drug and had evaluable baseline and postbaseline data for antibodies.||participants with immunogenicity samples|||Number
29827|NCT01606748|Primary|PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||ug*hour(h)/mL||Geometric Coefficient of Variation|Geometric Mean
29828|NCT01606748|Primary|PK: Dose-Normalized Cmax of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||nanogram (ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
29829|NCT01606748|Primary|PK: Dose-Normalized Cmax of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.||nanogram(ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
29830|NCT01606748|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
29831|NCT01606735|Primary|Anterior Chamber Cell Count at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.|8 days post-treatment|||percentage of patients with ACC clearing||95% Confidence Interval|Number
29832|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score|The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status.|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.||units on a scale||Standard Deviation|Mean
29833|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and 67 patients had complete data for UPDRS Part III. Thus, of the 70 patients in the FAS, 67 patients are included in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
29834|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 67 patients had complete data for UPDRS Part III and are included in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
29835|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and are included in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
29858|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36|The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.|Day 36|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
29836|NCT01606670|Primary|Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire|"The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF).~The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable).~8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain.~The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable."|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.||units on a scale||Standard Deviation|Mean
29837|NCT01606319|Secondary|Health Care Utilization|frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||unscheduled health visits per 46 weeks||95% Confidence Interval|Mean
29838|NCT01606319|Secondary|Asthma Rescue Medication Use|average albuterol rescue use per week, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||inhalations per week||95% Confidence Interval|Mean
29839|NCT01606319|Secondary|Asthma Control Days|proportion of study days on which asthma was controlled, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||proportion of days||95% Confidence Interval|Mean
29840|NCT01606319|Primary|Exacerbation Frequency|the number of asthma exacerbations requiring systemic corticosteroids|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.||asthma exacerbations per 46 weeks||95% Confidence Interval|Mean
29841|NCT01606254|Secondary|Number of Participants With Clinical Global Impression Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 8, 22, 50, 78 and 92|The PPS included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. LOCF imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.||Participants|||Number
29842|NCT01606254|Secondary|Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Day 8, 22, 50, 78 and 92|Per protocol set (PPS) included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. Last observation carried forward (LOCF) imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
29843|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 218|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
29844|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 162|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
29845|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 120|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
29859|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8|The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).|Day 8|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
29846|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 92|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
29847|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 78|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
29848|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 50|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
29849|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 22|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
29850|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 8|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once.||Participants|||Number
29851|NCT01606254|Primary|Paliperidone Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Days||Standard Deviation|Mean
29852|NCT01606254|Primary|Plasma Paliperidone Concentration at Steady State (Css av)|The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
29853|NCT01606254|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||nanogram*hour per milliliter||Standard Deviation|Mean
29854|NCT01606254|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Days||Full Range|Median
29855|NCT01606254|Primary|Maximum Observed Plasma Concentration (Cmax) of Paliperidone|The Cmax is defined as maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
29856|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92|The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.|Day 92|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
29865|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Day 90|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29866|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Baseline|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29867|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Day 90|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Day 90|Per Protocol (PP) population||participants|||Number
29868|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Baseline|Per Protocol (PP) population; participants for whom CGIS data was collected.||participants|||Number
29869|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Day 90|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Day 90|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29870|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Baseline|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|Per Protocol (PP) population||scores on a scale||Standard Deviation|Mean
29871|NCT01606228|Primary|The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, Day 90|Per Protocol (PP) population||percentage of patients|||Number
29872|NCT01606202|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the study is presented.|Up to 61 days|All randomised patients who received at least one dose of study drug were included in the Safety population.||participants|||Number
29873|NCT01606202|Secondary|Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment|Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29874|NCT01606202|Secondary|Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment|The Brief Pain Inventory is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29875|NCT01606202|Secondary|Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment|The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
29876|NCT01606202|Secondary|Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment|Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.|Up to 51 days|All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis.||units on a scale||Standard Deviation|Mean
29921|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29877|NCT01606202|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29878|NCT01606202|Secondary|Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment|"Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function .~A negative value from baseline indicates a deterioration."|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29879|NCT01606202|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 (“No increase in muscle tone”) to 4 (“Affected part(s) rigid in flexion or extension”) to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29880|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||percentage of days||Standard Deviation|Mean
29881|NCT01606202|Secondary|Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.|Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = “Mildest ever spasticity” to 10 = “Worst ever spasticity”. The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29882|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||percentage of days||Standard Deviation|Mean
29883|NCT01606202|Secondary|Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = “Mildest ever spasm” to 10 = “Worst ever spasm”. The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29884|NCT01606202|Secondary|Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment|The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||percentage of days||Standard Deviation|Mean
29885|NCT01606202|Primary|Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).|The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = ‘No Pain’ and 10 = ‘Worst Possible Pain’. Patients were instructed to relate ‘No Pain’ to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29886|NCT01606189|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of study is presented.|Up to 114 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||participants|||Number
29920|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29887|NCT01606189|Secondary|Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29888|NCT01606189|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with “no disability” and 10 equated with “total disability”. The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29889|NCT01606189|Secondary|Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as “No Pain”, “Mild”, “Discomforting”, “Distressing”, “Horrible” and “Excruciating”. The change from baseline in the number of patients who reported “No Pain” or “Mild Pain” at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||participants|||Number
29890|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero “No pain” to 100 “Worst possible pain”. Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29891|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = “None”, one = “Mild”, two = “Moderate” and three = “Severe”. The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29892|NCT01606189|Secondary|Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero “Worst Imaginable” to 10 “Best Imaginable”. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29893|NCT01606189|Secondary|Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as “None”, “Once”, “Twice” and “More Than Twice” and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29894|NCT01606189|Primary|Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)|Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero “no pain at all” to 10 “pain as bad as you can imagine”. The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
29895|NCT01606176|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event in the study is presented.|0 - 65 days|All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis.||participants|||Number
29896|NCT01606176|Secondary|Patient Global Impression of Change - Multiple Sclerosis Subset.|The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||participants|||Number
29986|NCT01605552|Secondary|Change in C-reactive Protein (CRP) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|||change in mg/L||Standard Deviation|Mean
29897|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
29898|NCT01606176|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
29899|NCT01606176|Secondary|Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks.|The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
29900|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks.|Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
29901|NCT01606176|Secondary|Use of Analgesic Escape Medication - Multiple Sclerosis Subset.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||percentage of days||Standard Deviation|Mean
29902|NCT01606176|Secondary|Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks.|Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.||units on a scale||Standard Deviation|Mean
29903|NCT01606176|Secondary|Patient Global Impression of Change at the End of 3 Weeks of Treatment.|The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||participants|||Number
29904|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
29905|NCT01606176|Secondary|Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
29906|NCT01606176|Secondary|Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.|The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
29907|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.|Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
29908|NCT01606176|Secondary|Use of Analgesic Escape Medication.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||percentage of days||Standard Deviation|Mean
29909|NCT01606176|Primary|Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.|Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
29910|NCT01606150|Secondary|Premature Infant Pain Profile (PIPP) Score|PIPP score assigned by a blinded outcome assessor by viewing video tapes of the infant's face during the procedure and vital sign changes during that time frame|data collected during the procedure, PIPP score assigned within one month by viewing collected data||||||
29911|NCT01606150|Primary|Lumbar Puncture Success Rate|Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000|immediately following the procedure||||||
29912|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29913|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29914|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29915|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days|All subjects who entered the study from a parent RCT investigation neuropathic pain due to multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29916|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29917|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29918|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29919|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
30010|NCT01605292|Other Pre-specified|Difficult Access Procedures >= 5 Attempts|Difficult procedures were defined as either requiring >= 5 attempts|Immediately during procedure (within 30 min)|||participants|||Number
29922|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29923|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||participants|||Number
29924|NCT01606137|Secondary|Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
29925|NCT01606137|Secondary|Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a neuropathic pain in multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
29926|NCT01606137|Secondary|Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
29927|NCT01606137|Secondary|Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks|All subjects who entered the study from a parent randomised controlled trial (RCT) investigating the efficacy of GW-1000-02 in the treatment of spasticity associated with multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.||units on a scale||Standard Deviation|Mean
29928|NCT01606137|Primary|Incidence of Adverse Events as a Measure of Subject Safety.|Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.|Up to 1051 days|All subjects who took part in the extension study were included in the analysis.||participants|||Number
29929|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24||Body weight Kg||95% Confidence Interval|Mean
29930|NCT01606007|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|At Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values||% of Participants||95% Confidence Interval|Number
29931|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24||mg/dL||95% Confidence Interval|Mean
29932|NCT01606007|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24 (LOCF)||MG/DL PPG||95% Confidence Interval|Mean
29933|NCT01606007|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24||% HbA1c||95% Confidence Interval|Mean
29934|NCT01605942|Secondary|Plasma Levels of Dexamethasone|Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.|Day 2, Day 7, Day 14|Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis.||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
30011|NCT01605292|Other Pre-specified|Radial Artery Spasm|Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation|Immediately during procedure (within 30 min)|||participants|||Number
29935|NCT01605942|Primary|Number of Patients With Clearance of Anterior Chamber Inflammation|The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).|Up to Day 71|Safety: all patients who received study treatment at randomization/surgery (day 1)||Patients|||Number
29936|NCT01605916|Secondary|AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
29937|NCT01605916|Secondary|Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
29938|NCT01605916|Secondary|Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
29939|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
29940|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
29941|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
29942|NCT01605916|Primary|AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
29943|NCT01605916|Primary|Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
29944|NCT01605916|Primary|Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
29945|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
29946|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
29947|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
29948|NCT01605916|Primary|AUC(0-12) of Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
29949|NCT01605916|Primary|Tmax of Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||hour||Full Range|Median
29950|NCT01605916|Primary|Cmax of Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
29951|NCT01605877|Secondary|Percentage of Participants With Positive Response, Quality of Life Questions|"The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, Yes=visual difficulty."|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||percentage of participants|||Number
29952|NCT01605877|Secondary|Percentage of Participants With Positive Response, Stereoscopic Vision Test|Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive).|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||percentage of participants|||Number
30012|NCT01605292|Secondary|First-pass Success Rate|Proportion of procedures achieving access on the first attempt|Immediate|Subgroup of patients with accurate number of attempts measured||participants|||Number
29953|NCT01605877|Secondary|Mean Defocus Decimal VA (5 m)|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||decimal||Full Range|Mean
29954|NCT01605877|Secondary|Best Corrected Near (46 cm) Contrast Sensitivity|Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||logMAR||Standard Deviation|Mean
29955|NCT01605877|Secondary|Best Corrected Far (3 m) Contrast Sensitivity|Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.||logMAR||Standard Deviation|Mean
29956|NCT01605877|Secondary|Mean Best Distance (cm) for Distance Corrected Decimal Near VA|VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||centimeters||Standard Deviation|Mean
29957|NCT01605877|Secondary|Mean Best Distance (cm) for Uncorrected Decimal Near VA|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|"This analysis population includes all implanted subjects. Here, n is the number of participants with non-missing values at the specific time point for each arm group, respectively."||centimeters||Standard Deviation|Mean
29958|NCT01605877|Secondary|Uncorrected Decimal VA at Best Distance|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29959|NCT01605877|Secondary|Distance Corrected Decimal VA (40 cm)|VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29960|NCT01605877|Secondary|Uncorrected Decimal VA (40 cm)|VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29961|NCT01605877|Secondary|Distance Corrected Decimal VA (1 m)|VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29962|NCT01605877|Secondary|Uncorrected Decimal VA (1 m)|VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29963|NCT01605877|Primary|Distance-Corrected Decimal VA (50 cm)|VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29964|NCT01605877|Primary|Best Corrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29965|NCT01605877|Primary|Best Corrected Decimal VA (5 m)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
31112|NCT01586364|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||nmol/L||Standard Deviation|Mean
29966|NCT01605877|Primary|Uncorrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29967|NCT01605877|Primary|Uncorrected Decimal VA (5 m)|Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.||participants|||Number
29968|NCT01605825|Other Pre-specified|Hand Strength as Measured by the Grip Test and Pinch Tests||Days 1, 8, 15, 22, 29, and 36||||||
29969|NCT01605825|Other Pre-specified|Clinician Global Impression (CGI) Scale||Days 8, 15, 22, 29 and 36||||||
29970|NCT01605825|Other Pre-specified|Subject Global Impression (SGI) Scale||Days 8, 15, 22, 29 and 36||||||
29971|NCT01605825|Other Pre-specified|Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale||Days 1, 8, 15, 22, 29, and 36||||||
29972|NCT01605825|Other Pre-specified|Manual Dexterity as Measured by the Box and Block Test||Days 1, 8, 15, 22, 29, and 36||||||
29973|NCT01605825|Other Pre-specified|Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)||Screening visit, Days 1, 8, 15, 22, 29, and 36||||||
29974|NCT01605825|Other Pre-specified|Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)||Screening visit, Days 1, 8, 15, 22, 29 and 36||||||
29975|NCT01605825|Primary|Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)|"A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment.~The severity categories of mild, moderate or severe, are defined below:~Mild is defined as causing no limitation of usual activities~Moderate is defined as causing some limitation of usual activities~Severe is defined as causing inability to carry out usual activities"|up to 36 days|Safety population. Number of participants analyzed is number of patients with TEAE's as described in outcome measure description. Excludes pre-treatment and post-treatment adverse events.||participants|||Number
29976|NCT01605799|Secondary|Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)|"The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., your feelings being easily hurt) on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days. The total score is the sum of all responses [minimum = 0 (better outcome), maximum = 212 (worse outcome)]."|The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in BSI between baseline and end of treatment will be measured using an intent to treat analysis.||Units on a scale||95% Confidence Interval|Mean
29977|NCT01605799|Primary|Change in PTSD Symptoms as Measured by the PCL|The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).|PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in PCL score from baseline to end of treatment will be measured using an intent to treat analysis.||Units on a scale||95% Confidence Interval|Mean
29978|NCT01605669|Primary|Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity|The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.|There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.|||participants|||Number
29979|NCT01605617|Secondary|Change in Score on Overactive Bladder Questionnaire (QAB-q)|"The QAB-q is a self-administered, 33-item questionnaire containing a symptom bother and health related quality of life scale. Each item has a choice of 6 responses, ranging from not at all to a very great deal. Therefore, the total score could range from 33 (no discomfort) to 198 (great discomfort)."|Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
29980|NCT01605617|Secondary|Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)|The IUSS has 4 levels: none, mild, moderate, and severe. An episode characterized as severe according to this scale would qualify as an urgency episode.|baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
29981|NCT01605617|Secondary|Volume Voided Per Day||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
29982|NCT01605617|Secondary|Number of Voids Causing Waking||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
29983|NCT01605617|Secondary|Mean Change in Urinary Urge Incontinence Episodes in 24 Hours||Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
29984|NCT01605617|Primary|Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.|||||
29985|NCT01605552|Secondary|Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One case was excluded from the usual care group due to extreme values.||change in pg/ml||Standard Deviation|Mean
29987|NCT01605552|Secondary|Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 Weeks|One participant in the usual care group did not complete the SCL-20 at the pre-treatment visit. Therefore a change score could not be computed for this participant. The remaining number of participants in usual care for this analysis was 13.||Change in scores on a scale||Standard Deviation|Mean
29988|NCT01605552|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients will undergo ultrasound assessment of brachial FMD in accordance with established guidelines. After a 10-minute supine rest, high-resolution baseline images of the brachial artery will be obtained from 3 consecutive cardiac cycles. Next, the forearm cuff will be inflated to 250 mmHg for 5 minutes and then will be rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles will be acquired. FMD values will be computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation.|0 and 12 weeks|||% increase in brachial diameter||Standard Deviation|Mean
29989|NCT01605539|Secondary|Vital Signs - Temperature|"Temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Temperature will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||degrees F||Standard Error|Mean
29990|NCT01605539|Secondary|Vital Signs - Respiratory Rate|"Respiratory rate (in breaths/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Respiratory rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||breaths per minute||Standard Error|Mean
29991|NCT01605539|Secondary|Vital Signs - Heart Rate|"Heart rate (in beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Heart rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||beats per minute||Standard Error|Mean
29992|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Negative Affect Assessment (NAS): 10 (minimum) – 50 (maximum). Higher score reflects stronger negative affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
29993|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Positive Affect Assessment (PAS): 10 (minimum) – 50 (maximum). Higher score reflects stronger positive affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
29994|NCT01605539|Secondary|Visual Analog Scale for Anxiety (VASA)|"Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). Scale: 0 (not at all anxious) - 10 (extremely anxious).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
30013|NCT01605292|Secondary|Time to Sheath Insertion (Seconds)|Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.|Immediately during procedure (within 30 minutes)|||seconds||Standard Deviation|Mean
29995|NCT01605539|Secondary|Vital Signs - Blood Pressure|"Blood pressure (mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Blood pressure will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||mmHg||Standard Error|Mean
29996|NCT01605539|Primary|Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)|"Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings).~** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session."|Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV|||units on a scale||Standard Error|Mean
29997|NCT01605539|Primary|Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)|"The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test"|VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)|||units on a scale||Standard Error|Mean
29998|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Faeces|Excretion of total [14C]-radioactivity in faeces|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
29999|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Urine|Excretion of total [14C]-radioactivity in urine|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
30000|NCT01605461|Primary|Excretion Balance of Total [14C]-Radioactivity|Excretion balance of total [14C]-radioactivity (urine and faeces)|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
30001|NCT01605461|Primary|t1/2 of [14C]-Radioactivity in Plasma|Terminal half life (T1/2) of [14C]-radioactivity in plasma|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set||hours||Geometric Coefficient of Variation|Geometric Mean
30002|NCT01605461|Primary|Cmax of Plasma Deleobuvir|Maximum measured concentration (Cmax) of plasma deleobuvir|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
30003|NCT01605461|Primary|AUC0-infinity of Plasma Deleobuvir|Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic analysis set (PK set) which included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
30004|NCT01605370|Primary|Change in Inappropriate Left Ventricular Mass (LVM)|LVM will be measured by echocardiography exam. LVM is inappropriate when observed LVM (oLVM) exceeds predicted LVM (pLVM) by more than 28%, that is, 100×(oLVM/pLVM) >128%.|baseline, 6 months|Data were not collected for the single participant, so no analysis was performed.|||||
30005|NCT01605292|Other Pre-specified|Pain Score|Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain.|2-8 hours after procedure|||units on a scale||Inter-Quartile Range|Median
30006|NCT01605292|Post-Hoc|Failure of Radial Sheath Insertion With Original Randomized Technique||Immediate|||participants|||Number
30007|NCT01605292|Post-Hoc|Crossover to Ultrasound Rescue Attempts After 5 Minutes|Patients randomized to palpation-guided access could have their procedure changed to ultrasound at operator discretion after 5 minutes of palpation-guided attempts.|5 minutes|Only patients randomized to palpation could potentially cross over to ultrasound technique.||participants|||Number
30008|NCT01605292|Other Pre-specified|Bleeding Complication|Any hematoma >2 cm or bleeding requiring intervention|After procedure (within 24 hours)|||participants|||Number
30009|NCT01605292|Other Pre-specified|Difficult Access >= 5 Minutes|Access that requires >= 5 minutes from first attempt to sheath insertion|Immediate (within 30 minutes)|||participants|||Number
30014|NCT01605292|Primary|Number of Attempts|Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.|Immediately during procedure. (up to 30 minutes)|473 patients of 698 had number of attempts measured correctly by number of forward passes. This subgroup of the whole population was used for analysis of number of attempts.||forward attempts||Standard Deviation|Mean
30015|NCT01603875|Secondary|Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.|"There are five injections, on day 0, 7, 28, 360 and 363.~The side effects will be record in number and percentage."|up to 7 days after each injection||||||
30016|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 374|||International unit per ml||Full Range|Geometric Mean
30017|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 360|||International unit per ml||Full Range|Geometric Mean
30018|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 42|||International unit per ml||Full Range|Geometric Mean
30019|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 28|||International unit per ml||Full Range|Geometric Mean
30020|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 0|||International unit per ml||Full Range|Geometric Mean
30021|NCT01604941|Secondary|Number of Participants Classified as a Responder by Serum Ferritin|A responder was defined as a participant whose observed serum ferritin level at the measured time point was less than the baseline value. Serum ferritin levels were determined from serum biochemistry analyses.|8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
30022|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas), and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
30023|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas). Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
30024|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures, and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
40557|NCT01449955|Secondary|Psychophysiology Measurements: Heart Rate|The participant's heart rate is monitored during a script-driven imagery procedure. This procedure involves listening to 4 scripts: 2 neutral, 2 combat-related.|one week after medication||||||
30025|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||participants|||Number
30026|NCT01604941|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
30027|NCT01604941|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were determined from serum biochemistry analyses. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||ng/mL||Standard Deviation|Mean
30028|NCT01604941|Secondary|Change From Baseline in Cardiac T2* Relaxation Rate, an MRI Parameter Used to Estimate Cardiac Iron Load|The efficacy of SPD602 was assessed by estimating cardiac iron load. T2* data from cardiac MRI were collected by using standard procedures and used as an estimate of cardiac iron load. T2* is an MR relaxation parameter that is reported in milliseconds. Iron within a tissue decreases homogeneity of the magnetic field and shortens the T2* relaxation rate (Anderson, 2001). Low cardiac T2* values are associated with increased risk of heart failure (Kirk, 2009). A negative change from baseline in the T2* relaxation rate indicates that iron load increased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||milliseconds||Standard Deviation|Mean
30029|NCT01604941|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
30030|NCT01604941|Secondary|Change From Baseline in LIC as Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
30031|NCT01604941|Primary|Change From Baseline in Liver Iron Concentration (LIC) as Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.||mg Fe/g*dw||Standard Deviation|Mean
30032|NCT01604850|Secondary|Percentage of Participants With Viral Relapse|"Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|End of treatment to posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||participants|||Number
30033|NCT01604850|Secondary|Percentage of Participants With Viral Breakthrough|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.~For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Up to 16 weeks|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
32022|NCT01569529|Primary|Program Enrollment|Rates of enrollment will be calculated as the proportion of visitors who enroll in treatment (e.g., number of enrollments/number of click-throughs from banner ads).|1-month intervals over 7 months|||proportion of click-throughs who enroll|Participants||Number
30034|NCT01604850|Secondary|Percentage of Participants Achieving SVR24|"SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
30035|NCT01604850|Secondary|Percentage of Participants Achieving SVR4|"SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 4|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
30036|NCT01604850|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug|Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.|Baseline to Week 16|The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.||participants|||Number
30037|NCT01604850|Primary|Percentage of Participants Achieving SVR12|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 12|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
30038|NCT01604772|Secondary|Incidence of Toxicities of Akt Inhibitor MK-2206|Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).|Time to first treatment to up to 30 days after completion of treatment||||||
30039|NCT01604772|Secondary|Overall Survival|Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.|Time of study entry to death due to any cause, assessed up to 3 years from registration|This endpoint has not been assessed yet.|||||
30040|NCT01604772|Secondary|Median Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time of study entry to progression or death, up to 3 years after registration|Two patients were deemed ineligible and were not included in this endpoint.||months||95% Confidence Interval|Median
30041|NCT01604772|Primary|Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1|"Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Up to 32 weeks|Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible patients.||percentage of patients||95% Confidence Interval|Number
30042|NCT01604278|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.|12 weeks|Safety Set: The safety set included all patients who received at least one dose of study drug whether or not they were randomized.||Number of participants|||Number
30043|NCT01604278|Secondary|Change From Baseline in Mean Daily Total and Individual Symptom Scores|The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied. For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom. The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Score||Standard Error|Least Squares Mean
30044|NCT01604278|Secondary|Transitional Dyspnea Index (TDI) Focal Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI). Analysis was done via mixed model. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of 1 is considered a minimal clinically important difference.|baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Score||Standard Error|Least Squares Mean
30045|NCT01604278|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Number of puffs||Standard Error|Least Squares Mean
30046|NCT01604278|Secondary|Inspiratory Capacity (IC) at Individual Time-points|Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
30047|NCT01604278|Secondary|Forced Vital Capacity (FVC) at Individual Time-points|FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Day 29, Day 57 and Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
30048|NCT01604278|Secondary|FEV1 at Individual Time-points|Centralized spirometry according to internationally accepted standards was used. FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|Day 1, Day 29, Day 57 and Days 84/85|Full Analysis Set||Liters||Standard Error|Least Squares Mean
30049|NCT01604278|Secondary|Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks|Centralized spirometry was used according to internationally accepted standards was used. Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect. If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
30050|NCT01604278|Secondary|FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose|Centralized spirometry was used according to internationally accepted standards was used. The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time. Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated). Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
30051|NCT01604278|Primary|Trough Forced Expiratory Volume at 1 Second (FEV1)|Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.||Liters||Standard Error|Least Squares Mean
30052|NCT01604265|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of the study is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||participants|||Number
30053|NCT01604265|Secondary|Change From Baseline in the Multiple Sclerosis Functional Composite Score at the End of Treatment (4 Weeks)|The Multiple Sclerosis Functional Composite test is a three-part, standardized, quantitative, assessment instrument for use in clinical studies. The three components of the test measure leg function/ambulation, arm/hand function, and cognitive function. An increase in score indicates an improvement (range -3 to +3).|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30054|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Anxiety at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall anxiety score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30055|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Depression at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall depression score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30056|NCT01604265|Secondary|Change From Baseline in the Mean 0-100 mm Visual Analogue Scale Score for Intoxication Levels at the End of Treatment (4 Weeks)|Intoxication levels were recorded on a Visual Analogue Scale, where zero equated with “no intoxication” and 100 equated with “extreme intoxication”. A decrease in baseline score indicates a reduction in intoxication.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30057|NCT01604265|Secondary|Change From Baseline in the Mean Total Guy’s Neurological Disability Scale Score at the End of Treatment (4 Weeks)|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30058|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment (4 Weeks)|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||number of words||Standard Deviation|Mean
30059|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for the 'Paced Auditory Serial Addition Task' (PASAT) at the End of Treatment (Week 4)|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||percentage of correct answers||Standard Deviation|Mean
30060|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment (Week 4)|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30061|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment (Week 4)|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Weeks 0 - 4|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30062|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment (Week 4)|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Baseline to end of study (0 - 4 weeks)|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30063|NCT01604265|Secondary|Change From Baseline in the Mean Neuropathic Pain Scale 0-10 Numerical Rating Scale Score at the End of Treatment (Week 4)|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = worst pain imaginable). A negative change from baseline indicates an improvement in pain.|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
32142|NCT01568008|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All patients with complete data available for IOP.||mm Hg||Standard Deviation|Mean
30064|NCT01604265|Secondary|Subject Global Impression of Change at Week 4|A 7-point Likert-type scale was used, with the question: ‘Please assess the improvement in overall condition since the start of the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at Week 4 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||participants|||Number
30065|NCT01604265|Secondary|Change From Baseline in the Mean 0-10 Numerical Rating Scale Sleep Score at the End of Treatment (4 Weeks)|Each day patients were asked to record in their subject diary, whether or not they were “woken due to nerve pain last night”, using a 0-10 Numerical Rating Scale sleep score where zero equated with “did not disrupt sleep” and 10 meant “completely disrupts sleep (unable to sleep due to pain)”. A decrease in score from baseline indicates an improvement.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30066|NCT01604265|Primary|Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)|"The average pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. A negative value indicates an improvement in pain score from baseline."|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
30067|NCT01604109|Secondary|Quantitative Light-induced Fluorescence (QLF) Parameters|percent fluorescence loss, lesion area, lesion volume|one calender year||||||
30068|NCT01604109|Primary|the Mean Number of Enamel Carious Lesion|tooth surface that was classified as ICDAS code 1-3|one calender year|||Surfaces||Standard Deviation|Mean
30069|NCT01603940|Secondary|Vascular Stiffness by Augmentation Index|Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.|12 weeks|||percentage of augmentation pressure||Inter-Quartile Range|Median
30070|NCT01603940|Secondary|Diastolic Blood Pressure|Compare both group effects on diastolic blood pressure.|12 weeks|||mmHg||Inter-Quartile Range|Median
30071|NCT01603940|Secondary|Systolic Blood Pressure|Compare both groups effects on systolic blood pressure.|12 weeks|||mmHg||Inter-Quartile Range|Median
30072|NCT01603940|Secondary|Vascular Stiffness|Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).|12 weeks.|||m/s||Inter-Quartile Range|Median
30073|NCT01603940|Primary|Endothelial Function|Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.|12 weeks|||percentage of maximal vasodilation||Inter-Quartile Range|Median
30074|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30075|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
30076|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30088|NCT01603459|Secondary|Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30077|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
30078|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30079|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||Subjects|||Number
30080|NCT01603459|Secondary|Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome). Frequency 1= Best, 2= Intermediate, 3= Worst value.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30081|NCT01603459|Secondary|EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day. Frequency 1= Best, 2= Intermediate, 3= Worst value.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
30082|NCT01603459|Secondary|Global Assessment of Efficacy Scores|Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
30083|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit.|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30084|NCT01603459|Primary|Investigator’s Global Assessment of Tolerability in Subjects|A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Up to Week 48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
30085|NCT01603459|Primary|Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication|Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.|From baseline to week 36-48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.||subjects|||Number
30086|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30087|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30108|NCT01603420|Secondary|Assessment of Total Number of Survival Events With Comparison of Group Arms|The number of deaths in both arms will be assessed.|at study closure (22 months)|||participants|||Number
30109|NCT01603420|Secondary|Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.|The total number of subjects with salvage androgen deprivation use will be assessed.|At study closure (22 months)|||participants|||Number
30089|NCT01603459|Secondary|Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively|Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk & Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment.|From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30090|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30091|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30092|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30093|NCT01603459|Secondary|Functional Ambulation Classification (FAC) Scale Scores|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30094|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 12-16, 24-32 and 36-48|The full analysis set is the subset of all subjects who were exposed to study medication at least once.||units on a scale||Standard Deviation|Mean
30095|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 4, 16-20 and 28-36|The full analysis set is the subset of all subjects who were exposed to study medication at least once.||units on a scale||Standard Deviation|Mean
30096|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30110|NCT01603420|Secondary|Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination|||||
30111|NCT01603420|Secondary|Assessment of Total Number of Local/Distant Failures|The total number of local/distant failures will be assessed.|at time of study closure (22 months)|||participants|||Number
30097|NCT01603459|Secondary|Resistance to Passive Movement Scale (REPAS) Scores of Treated Side|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30098|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30099|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30100|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.||units on a scale||Standard Deviation|Mean
30101|NCT01603459|Secondary|Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern in the respective injection cycle.||units on a scale||Standard Deviation|Mean
30102|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
30103|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
30104|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
30105|NCT01603459|Secondary|Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|The full analysis set (FAS) is the subset of all subjects who were exposed to study medication at least once. Only subjects treated in the target joint in the respective cycle were analyzed.||units on a scale||Standard Deviation|Mean
30106|NCT01603420|Secondary|Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination|||||
30107|NCT01603420|Secondary|Assessment of Total Number of Biochemical Failure Events|The number of biochemical failure events will be assessed on both arms.|at study closure (22 months)|||participants|||Number
30112|NCT01603420|Secondary|Assessment of Number of GI and GU Adverse Events|"Descriptive measurements of frequency will be compiled.~This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure."|at 3 years||||||
30113|NCT01603420|Secondary|Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events|Assessment will be performed using CTCAE v 4 criteria.|at 6 months|||incidences|||Number
30114|NCT01603420|Primary|Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.|"The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation.~This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years|This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.|||||
30115|NCT01603420|Primary|Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.|"Assessment will be performed using CTCAE v4 criteria.~This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|2 years|This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).||events|||Number
30116|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm|"This endpoint will be examined if decision is made to not move forward with phase 3 study.~This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years||||||
30117|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm|"Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen [PSA] > = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation.~This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.||failure events|||Number
30118|NCT01603394|Secondary|Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.|The pain-related sleep interference item rating scale is scored on an 11-point numeric rating scale (NRS-Sleep). It is self-administered by the participant in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30119|NCT01603394|Secondary|Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.|The Short-Form 12 Health Survey (SF-12v2) is a self-administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. Higher scores indicate a better health-related quality of life.|Visit 2 (Week 0), and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30120|NCT01603394|Secondary|Pain NRS Score; 1 Week Recall Period.|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|1 Week|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30121|NCT01603394|Secondary|Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.|The PCS is a 13-item self report instrument and requires a Grade 6 reading level and has been translated into 12 languages. It instructs participants to reflect on past experience of pain and indicate their experience using a 5-point scale. The PCS was designed for research on catastrophizing and pain experience. Catastrophizing is associated with heightened pain and is “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.” It is a multidimensional construct compromising elements of rumination, magnification, and helplessness and its factor structure has been replicated. It has a total score and three subscale scores (score range of 0-52).|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30122|NCT01603394|Secondary|Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.|The Brief Pain Inventory-Short Form (BPI-sf) consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11-point scale from 0 (no pain) to 10 (worst pain possible).|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30123|NCT01603394|Secondary|Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination.|The PHQ-8 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The PHQ-8 is a validated subset of the PHQ-9, which comprises the first 8 items of the measure. The GAD-7 is a 7-item questionnaire that assesses anxiety. Participants respond as to how each item applies to them on a 4 point response scale. The higher the score, the more severe the anxiety.|Screening, Visit 2 (Week 0) and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30124|NCT01603394|Secondary|Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30125|NCT01603394|Secondary|Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.|The daily pain diary consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants describe their pain during the previous 24 hours by choosing the appropriate number between 0 and 10. Self-assessment is performed daily at bedtime on a telephone via interactive voice response system (IVRS). The endpoint mean pain score is defined as the mean of the last 7 daily diary pain ratings while taking study medication in the open-label phase. Daily pain IVRS diaries were completed daily at bedtime from Visit 1 (Screening) through Visit 7/Early Termination. Participants were asked to complete their first IVRS daily at bedtime on the morning after Visit 1.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30126|NCT01603394|Secondary|Patient Global Impression of Change (PGIC) at Week 6/Early Termination.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30127|NCT01603394|Secondary|Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline. Then for each of the above phenotypes the distribution of the pregabalin responders (using 30% and 50%) were to be compared.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30128|NCT01603394|Secondary|Neuropathic Pain Symptom Inventory (NPSI) at All Visits.|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|All visits|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30129|NCT01603394|Primary|Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.|||||
30130|NCT01603277|Secondary|To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments||Week 24||||||
30131|NCT01603277|Secondary|To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)||Week 24||||||
30132|NCT01603277|Secondary|To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate||Week 24||||||
30133|NCT01603277|Primary|Change in Percent Predicted FEV1 at Week 24||Baseline to Week 24|||Percent||Standard Deviation|Mean
30134|NCT01603121|Secondary|Evaluation of Early Efficacy of Study Drug|Blood draws will be performed at predetermined time points during and after the infusions in order to measure serum cytokine and chemokine concentrations, as well as to measure plasma STAT 4 and phosphorylated STAT 4 (markers of lisofylline efficacy).|24 hours||||||
30135|NCT01603121|Secondary|Study Drug Bioavailability After Subcutaneous and Intravenous Infusion|Blood will be collected for determination of lisofylline concentrations at various predetermined time points during the infusions, and 10 and 24 hours following infusion completion. This will help to determine if subcutaneous infusion over 10 hours results in similar lisofylline plasma concentrations as with intravenous infusion.|24 hours||||||
30136|NCT01603121|Primary|Safety and Tolerability of Study Drug|"Subjects will be monitored for adverse events both during and after the study drug infusion and will undergo physical examinations, electrocardiograms and clinical safety laboratory tests.~Study staff will contact subjects within 5 days after each dosing period and approximately 30 days after the 2nd dosing period, to review laboratory results and to ask the subject about any changes in health that they have experienced. Should the subject require an in-person evaluation, this will be arranged with the principal or sub-investigator promptly."|1 month||||||
30137|NCT01603082|Secondary|Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|0.5 hours, end of PCI, and 8 hours after the loading dose|PD Analysis Set. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.||PRU||Standard Deviation|Mean
30138|NCT01603082|Primary|Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.||PRU||Standard Deviation|Mean
32227|NCT01566461|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).||Percentage of devices|Devices||Number
30139|NCT01603056|Secondary|The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Asthma symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily asthma medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Medication score)||Standard Deviation|Mean
30140|NCT01603056|Secondary|The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months’ RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better.|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(AQLQ score)||Standard Deviation|Mean
30141|NCT01603056|Secondary|The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Rhinitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily Rhinitis medication score range from 0 to 30. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Medication score)||Standard Deviation|Mean
30142|NCT01603056|Secondary|Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.|Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated.|Visit 9 date, Week 52|The analysis was performed in the Full Analysis Set.||participants|||Number
30143|NCT01603056|Secondary|The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|"The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52).~The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better."|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (RQLQ score)||Standard Deviation|Mean
30144|NCT01603056|Secondary|The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated.|"The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question ‘How have your nasal complaints been today?’ from 0 = no symptoms to 10 = severe symptoms.~The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52)."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (VAS Score)||Standard Deviation|Mean
30145|NCT01603056|Secondary|Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.|A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days.|Total study year|The analysis was performed in the Full Analysis Set.||Percentage of healthy days||Standard Deviation|Mean
30146|NCT01603056|Secondary|The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 4 symptoms as follows: Cough, Wheeze, Chest tightness/shortness of breath (dyspnoea), Exercise induced symptoms. The 4 symptom scores were summed to obtain the asthma symptoms score with range 0(best) to 12(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Symptom score)||Standard Deviation|Mean
30158|NCT01602744|Secondary|Pharmacoeconomics Analysis-Costs of Medication|The costs on medications in the geriatric hospital before and after intervention e.g. pharmaeconomic analysis of the intervention. Costs of medications were calculated in New Israeli shekels per month and taken from the Ministry of Health's medication price list.|Outcome measures were assessed at the end of the 12 month follow up|||New Israeli shekels per month||Standard Deviation|Mean
30359|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30147|NCT01603056|Secondary|The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 2 symptoms as follows: Gritty feeling/red/itchy eyes, Watery eyes. The 2 symptom scores were summed to obtain the conjunctivitis symptoms score with range 0(best) to 6(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale(Symptom score)||Standard Deviation|Mean
30148|NCT01603056|Secondary|The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 4 symptoms are as follows: Runny nose, Blocked nose, Sneezing, Itchy nose. The 4 symptom scores were summed to obtain the rhinitis symptoms score with range 0(best) to 12(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (Symptom score)||Standard Deviation|Mean
30149|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (Medication Score)||Standard Deviation|Mean
30150|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms.~The six symptoms are classified in 2 groups as follows:~Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.||units on a scale (Symptom Score)||Standard Deviation|Mean
30151|NCT01603043|Secondary|Mean Change From Baseline in BCVA at Month 12|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), Month 12||||||
30152|NCT01603043|Secondary|Yearly GA Lesion Size Growth Rate|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), up to Month 12||||||
30153|NCT01603043|Primary|Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Day 0 (injection visit), Month 12||||||
30154|NCT01602744|Primary|Functional Independence Measure (FIM)|Functioning was assessed by the FIM score. The FIM rates 18 activities of daily living on a 7 point scale ranging from fully dependent (=1) to independent (=7). A maximum score of 126 indicates functional independence and the lowest score of 18 indicates functional dependence.|Outcome measures were assessed at the end of the 12 month follow up|||units on a scale||Standard Deviation|Mean
30155|NCT01602744|Primary|Hospitalizations|The average number of hospitalizations per year.|Outcome measures were assessed at the end of the 12 month follow up|||Number of hospitalizations per year||Standard Deviation|Mean
30156|NCT01602744|Primary|Falls|Average number of falls per year.|At the end of the 12 month follow up|||Number of falls per year||Standard Deviation|Mean
30157|NCT01602744|Primary|SF-12 Health Survey questionnaire-the Physical Component Summary (PCS)|Quality of life was assessed by the SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores:the Physical Component Summary (PCS) AND Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up|||units on a scale||Standard Deviation|Mean
30222|NCT01601977|Secondary|Control of Nocturnal Hypoventilation|mean tcCO2|2 weeks|||kPa||Standard Deviation|Mean
30159|NCT01602744|Primary|Quality of Life- Mental Component Summaty (MCS)|Quality of life will be measured by MOS SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores: The Physical Component Summary(PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up|||units on a scale||Standard Deviation|Mean
30160|NCT01602731|Primary|Feasibility of AMDD to Improve Medication Adherence Via Completion Rate|Rate that patient population completed set-up of AMDD was evaluated quantitatively.|4 months|Of 45 patients who started the study, 24 patients met the predetermined criteria for AMDD. Though all of the patients had agreed to set up the AMDD in their home, only 15 out of 24 ended up completing the setup in their home.||participants|||Number
30161|NCT01602731|Secondary|Efficacy of AMDD to Improve Medication Adherence|Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD|30-day pill count before the use of AMDD and with AMDD|||percentage of adherence||Full Range|Mean
30162|NCT01602562|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
30163|NCT01602562|Secondary|Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35|Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Beats per minute||Standard Deviation|Mean
30164|NCT01602562|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Millimeters of mercury||Standard Deviation|Mean
30165|NCT01602562|Secondary|Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||ratio||Standard Deviation|Mean
30166|NCT01602562|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category.|Screening (SCR), Day 14, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
30167|NCT01602562|Secondary|Mean Hemoglobin Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Grams per liter (G/L)||Standard Deviation|Mean
30168|NCT01602562|Secondary|Mean Red Blood Cell Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||tera (10^12) per liter (TI/L)||Standard Deviation|Mean
30169|NCT01602562|Secondary|Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
30223|NCT01601977|Secondary|Total Sleep Time|Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST|baseline, 6 weeks|||minutes||Standard Deviation|Mean
40558|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|Self-report measure of depressive symptoms|change in QIDS score from baseline to 1 week posttreatment||||||
30170|NCT01602562|Secondary|Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Percentage of cells in blood||Standard Deviation|Mean
30171|NCT01602562|Secondary|Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Grams per liter (G/L)||Standard Deviation|Mean
30172|NCT01602562|Secondary|Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
30173|NCT01602562|Secondary|Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
30174|NCT01602562|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||International units per liter (IU/L)||Standard Deviation|Mean
30175|NCT01602562|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Safety Population: All participants who received VACV more than once.||Participants|||Number
30176|NCT01602562|Primary|Number of Participants With a Herpes Simplex Virus (HSV) Infection|Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Full Analysis Set (FAS): all participants who were given VACV more than once and who could provide data evaluable with respect to the occurrence of HSV infection.||Participants|||Number
30177|NCT01602549|Secondary|GSK962040 Tmax at Day1 and Day 8|GSK962040 tmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Hours||Full Range|Median
30178|NCT01602549|Secondary|GSK962040 Cmax at Day1 and Day 8|GSK962040 Cmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
30179|NCT01602549|Secondary|GSK962040 Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) at Day 1|GSK962040 %AUCex was derived from GSK962040 plasma concentration-time data. %AUCex is the percentage of the AUC(0-inf) extrapolated from the last PK sample drawn to infinity. This parameter is only reported in conjunction with single-dose AUC(0-inf). Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure.|Day 1|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Percentage||Geometric Coefficient of Variation|Geometric Mean
30180|NCT01602549|Secondary|GSK962040 Area Under the Plasma Concentration-time Curve From Zero to 5.5 Hours (AUC[0-5.5] and Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC[0-inf]) at Days 1 and 8|GSK AUC(0-5.5) and AUC(0-inf) were derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure. Data for AUC(0-inf) was analyzed and was only available for Day 1 and not for Day 8.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms.hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
30181|NCT01602549|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, is associated with liver injury and impaired liver function, or are serious events as per the medical or scientific judgment.|From the start of study medication until Follow-up (up to Day 25)|All Subjects Population||Participants|||Number
30182|NCT01602549|Secondary|Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8|RET measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Tera (10^12) cells per liter||Standard Deviation|Mean
30183|NCT01602549|Secondary|Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8|RBC and WBC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Giga (10^9) cells per liter||Standard Deviation|Mean
30184|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8|MCV measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Femtoliters||Standard Deviation|Mean
30185|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8|MCH measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Picograms||Standard Deviation|Mean
30186|NCT01602549|Secondary|Change From Baseline in Hematocrit at Day 4 and Day 8|Hematocrit measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||proportion of 1||Standard Deviation|Mean
30187|NCT01602549|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8|Hemoglobin and MCHC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Grams per liter||Standard Deviation|Mean
30188|NCT01602549|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8|Basophils, eosinophils, lymphocytes, monocytes, total ANC, and PC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Giga (10^9) cells per liter||Standard Deviation|Mean
30189|NCT01602549|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content (CO2)/Bicarbonate (BC), Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN), and Uric Acid (UA) at Day 4 and Day 8|Calcium, chloride, CO2/BC, glucose, potassium, sodium, urea/BUN, and UA measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Millimoles per liter||Standard Deviation|Mean
30190|NCT01602549|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) at Day 4 and Day 8|ALP, ALT, AST, and GGT measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||International units per liter||Standard Deviation|Mean
30191|NCT01602549|Secondary|Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8|ALB and TP measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Grams per liter||Standard Deviation|Mean
30192|NCT01602549|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. ECG findings were categorized as normal, abnormal - not clinically significant, and abnormal - clinically significant (CS), based on interpretation by the site.|Day 1 and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Participants|||Number
30193|NCT01602549|Secondary|Change From Baseline in Heart Rate at Day 1 and Day 8|Heart rate measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.||Beats per minute||Standard Deviation|Mean
30224|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|6 weeks|||units on a scale||Standard Deviation|Mean
30194|NCT01602549|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8|Blood pressure measurements were taken at pre-dose and at 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population (ASP): all participants who received >=1 dose of study medication. Participants with available data (n=X, X in category titles) were analyzed.||Millimeters of mercury||Standard Deviation|Mean
30195|NCT01602549|Secondary|Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|Various formulations of L-DOPA were utilized by participants for the treatment of Parkinson’s Disease. The total daily L-DOPA equivalent dose was calculated as the sum of all L-DOPA equivalent doses for each L-DOPA-containing drug taken on the same day.|Baseline and Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Milligrams||Standard Deviation|Mean
30196|NCT01602549|Secondary|Number of Times a Participant Could Alternatively Tap Two Counter Keys 30 Centimeters Apart in 1 Minute (Min) at Baseline, Day1, Day 8, and Follow-up|Participants were asked to alternatively tap two keys 30 centimeters apart in 1 minute in two trials with the most affected hand or the dominant hand in symmetric disease. The finger tapping was scored manually by the study staff. The finger-tapping assessment was repeated at eight separate time points (pre-dose, 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, and 240 min post-dose) at each visit (Baseline, Day 1, and Day 8). At each time point, the mean of the two assessments was calculated.|Baseline, Day 1, and Day 8 at pre-dose and 0, 30, 60, 90, 120, 180, and 240 minutes post-dose; Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Finger taps per minute||Standard Deviation|Mean
30197|NCT01602549|Secondary|"Period Mean Amount of Hours Spent “ON,” “ON” Without Dyskinesia, ON With Non-troublesome Dyskinesia, ON With Troublesome Dyskinesia, and “OFF” at Baseline and During the Treatment Period (Days 1-8), Week 1 of Follow-up, and Week 2 of Follow-up"|"Participants were provided with the ON/OFF diary to capture details of the amount of awake time spent on/off of PD symptoms, and were asked to complete the diary daily. Participants checked the box most appropriate for their dominant motor state in the preceding 30-minute period. The catergories included: ON (including “ON without dyskinesia” and “ON with non-troublesome dyskinesia), ON with troublesome dyskinesia (TD), and OFF. For Baseline, data were collected for 2 days prior to Day 1, and the mean value of the 2 days was used."|Baseline, Days 1-8, Week 1 of Follow-up (Days 6 and 7 of Follow-up; up to Day 16), and Week 2 of Follow-up (Days 13 and 14 of Follow-up; up to Day 23)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||hours||Standard Deviation|Mean
30198|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Scores at Baseline, Day 1, and Day 8 (Pre-dose; 120, 180, and 240 Minutes Post-dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-dose and 120, 180, and 240 minutes (min) post-dose (PD); Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
30199|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-levodopa dose|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Scores on a scale||Standard Deviation|Mean
30200|NCT01602549|Secondary|Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8|Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 8, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Minutes||Standard Deviation|Mean
30201|NCT01602549|Primary|L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8|L-DOPA t1/2 was derived from L-DOPA plasma concentration-time data. This endpoint was not assessed because there were insufficient L-DOPA data/profiles to calculate this parameter.|Baseline, Day 1, and Day 8||||||
30202|NCT01602549|Primary|L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8|L-DOPA Tmax was derived from L-DOPA plasma concentration-time data.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Hours||Full Range|Median
40559|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|Self-report measure of depressive symptoms|change in QIDS score from baseline to 3 months posttreatment||||||
30203|NCT01602549|Primary|Dose-normalized L-DOPA Cmax at Day 1 and Day 8|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms/milliliter/milligram||Standard Error|Least Squares Mean
30204|NCT01602549|Primary|Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data.|Baseline|PD/Efficacy Population. Only those participants available at the specified time point were analyzed.||Nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
30205|NCT01602549|Primary|Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios (GSK962040 50 mg: Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa pharmacokinetic (PK) parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. AUC is a measure of levodopa exposure|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.||Nanograms*hour/milliliter/milligram||Standard Error|Least Squares Mean
30206|NCT01602549|Primary|Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. AUC is a measure of levodopa exposure.|Baseline|Pharmacodynamic (PD)/Efficacy Population: participants receiving >=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed.||Nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
30207|NCT01602510|Secondary|Change From Baseline in Body Weight|Participant’s body weight was measured on Weeks 0, 4, 8, 12, 16, 20, 24, 32 and 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline score, treatment and baseline body weight. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The baseline value was defined as the last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks.|RD Full Analysis Population. Only those par. with available data at indicated time points were analyzed.||Kilograms||Standard Error|Least Squares Mean
30208|NCT01602510|Secondary|Change From Baseline of Global Assessment Scale (GAS) Total Score|For GAS, investigators rated par. for lowest level of functioning during the previous week. The scale has a 10 score categories: 1-10, 11-20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, 91-100, using intermediary levels when appropriate (from 100 to 1, Lower is worse.). Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and GAS total BL score. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The BL value was defined as the last non-missing values at or prior to the randomization. The change from BL at the time point of interest was calculated by subtracting the BL values from the individual post-BL values. If either the BL or post-BL value was missing, the change from BL was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population||Score on a scale||Standard Error|Least Squares Mean
30209|NCT01602510|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS consists of 11 items: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech, Language/Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance, and Insight. Investigators rated par. from 0 to 4 (or 8) for each of these items. Total score is the sum of all subscales, from 0 to 60 (higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and YMRS total BL score. In LOCF datasets, the last non-missing OT score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. BL value was defined as the last non-missing values at or prior to the randomization. Change from BL at the time point of interest was calculated by subtracting BL value from the individual post-BL value. If either the BL or post-BL value was missing, change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population||Score on a scale||Standard Error|Least Squares Mean
30210|NCT01602510|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAMD)|HAMD consists of 17 items: depressed mood, feelings of guilt, suicide, insomnia-early, middle, late, work and activities, retardation, agitation, anxiety psychic, anxiety somatic, somatic symptoms gastro-intestinal, general somatic symptoms, hypochondriasis, loss of weight, and insight. Investigators rated par. from 0 to 4 (or 2) for these items. Total score is sum of all subscales (0 to 52, higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline (BL) score, treatment and HAMD total BL score. The last non-missing OT score prior to TIME was carried forward to estimate missing data points for remaining study visits of the treatment period. BL value was defined as the last non-missing value at or prior to the randomization. Change from BL was calculated by subtracting BL from the specific post-BL value. If BL or post-BL value was missing, the change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population||Score on a scale||Standard Error|Least Squares Mean
30225|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|2 weeks|||units on a scale||Standard Deviation|Mean
30226|NCT01601977|Primary|Control of Nocturnal Hypoventilation|transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device|baseline, 6 week assessment|||kPa||Standard Deviation|Mean
30227|NCT01601821|Secondary|Number of Participants Who Discontinued|Number of participants who discontinued the study treatment due to any reason is reported.|Month 12|Analysis population included all participants enrolled in the study.||participants|||Number
32597|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - Tumour Necrosis Factor (TNF)|Change in serum cytokine TNF-alpha from Baseline to Final Visit|Baseline to end of treatment (10 week treatment period)|ITT analysis set||pg/mL||Standard Deviation|Mean
30211|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S)|The CGI-S is a 7-point scale where investigator were asked to rate the severity of the participant’s illness at the time of assessment on severity of mental illness, where 1= normal, and 7= extremely ill. Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32 and 36. Analysis performed using Analysis of Covariance (ANCOVA) with covariates of site, CGI-S baseline score (Open label phase), treatment and CGI-S baseline score. In presented Last observation carried forward (LOCF) datasets, last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for remaining study visits of treatment period. The baseline value was defined as last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population.||Score on a scale||Standard Error|Least Squares Mean
30212|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Improvements (CGI-I)|The CGI-I is a 7-point scale where investigator were asked to assess the participant’s illness at the time of assessment (improved or worsened) relative to a baseline state. In this scale, 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; or 7= very much worse. Analysis was performed using Analysis of covariance with covariates of site, CGI-S baseline score and treatment. In presented Last-observation-carried-forward datasets, the last non-missing on therapy (OT) score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. Baseline value was defined as the last non-missing values at or prior to the randomization. Change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either baseline or post-baseline value was missing, the change from baseline was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population.||Score on a scale||Standard Error|Least Squares Mean
30213|NCT01602510|Secondary|Overall Survival in Study (TIME-SIS).|TIME-SIS was defined as the time to intervention (addition of pharmacotherapy or ECT) for any mood episode, or to the time when the participant is withdrawn for any reason after randomization. The premature discontinuation of a participant prior to reaching TIME, for any reason, was treated as an event related to bipolar disorder. All participants prematurely discontinued prior to the TIME event in this analysis were to be assumed to have reached TIME. TIMS-SIS was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
30214|NCT01602510|Secondary|Time to Intervention for Depressive Episode (TIDep)|TIDep was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
30215|NCT01602510|Secondary|Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan)|TIMan was analyzed using using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population.NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
30216|NCT01602510|Primary|Time to Intervention for Any Mood Episode (TIME)|TIME is defined as being the time from entry into the randomized double-blind phase to the time of the first prescription of any additional pharmacotherapy or Electroconvulsive therapy (ECT) determined by the investigator to be necessary for treatment of a relapse and/or recurrence of a depressive, manic, hypomanic or mixed episode, whichever occurs first. TIME was measured relative to randomization date. Par. prematurely discontinued from the study prior to reaching the TIME event were censored at the time of discontinuation. Analysis was performed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level.|36 weeks (wks)|"Randomized (RD) Full analysis population: comprised of all randomized par. who took at least one dose of study medication and had at least one post-baseline efficacy/health outcomes assessment during randomized double-blind phase. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."||Days||95% Confidence Interval|Median
30217|NCT01602471|Primary|[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan|Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.|Participants will be followed for an average of 6 weeks||||||
30218|NCT01602016|Secondary|Improved Stereotyped Behavior and Improved Social Skills|Stereotyped behavior (as measured by the OACIS (not at 6 weeks), ASQ, RBS-R, and ABC) and social skills (as measured by the Vineland (not at 6 weeks), ASQ, and SRS) will be the secondary outcomes.|(baseline, 6, and 12 weeks)||||||
30219|NCT01602016|Primary|Language Improvement|Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.|(baseline and 12 weeks )|As the sponsor we were unable to validate any information or data from this study thru the monitoring process. The study was terminated by both the FDA and the sponsor for PI noncompliance.|||||
30220|NCT01601977|Secondary|Exacerbation Frequency|patient reported exacerbations following 6 weeks of device usage|6 weeks|||exacerbations|||Number
30221|NCT01601977|Secondary|Exercise Capacity|6 minute walk test|6 weeks|1 patient declined to complete the walking test||m||Standard Deviation|Mean
30228|NCT01601821|Secondary|Incidence of Anemia|Diagnostic criterion for anemia was based on the laboratory results; in men: hemoglobin (Hb) <14 gram per deciliter (g/dL), hematocrit (Hct) <42%, or red blood cells (RBCs) <4.5 million/liter (million/L); for women: Hb <12 g/dL, Hct <37%, or RBC < 4 million/L. Percentage of participants with anaemia was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
30229|NCT01601821|Secondary|Percentage of Participants With Efficacy Failure or Premature Elimination|Efficacy failure was defined as the first occurrence of acute rejection, graft loss, or death. Premature elimination was defined as elimination from the study for any other reason.|Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
30230|NCT01601821|Secondary|Incidence of Histologically Confirmed Lymphoproliferative Disease|Lymphoproliferative disorder represents an abnormal proliferation of B cells in response to either primary or reactivated infection with Epstein-Barr virus. Percentage of participants with histologically confirmed lymphoproliferative disease was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
30231|NCT01601821|Secondary|Incidence of Presumptive or Documented Infection|Presumptive or documented infection during the 12 months after transplantation; was confirmed by culture, biopsy, or serology and reported. Percentage of participants with presumptive or documented infection was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
30232|NCT01601821|Secondary|Percentage of Participants With Graft Survival|Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Month 12|PP4 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of graft loss.||percentage of participants|||Number
30233|NCT01601821|Secondary|Percentage of Participants Who Survived|Survival defined as participants living with or without a functioning graft.|Month 12|PP3 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of death.||percentage of participants|||Number
30234|NCT01601821|Secondary|Histologic Grade of First Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria. Grade 1A: cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: with severe tubulitis (>10 cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis and Grade 3: transmural arterits and/or fibrinoid necrosis. Data is reported as percentage of participants.|Baseline up to Month 12|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
30235|NCT01601821|Secondary|Incidence of Biopsy-Confirmed Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy using Banff criteria. Percentage of participants with biopsy-confirmed acute rejection was reported.|Baseline up to Month 6|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6.||percentage of participants|||Number
30236|NCT01601821|Secondary|Glomerular Filtration Rate (GFR) by Nankivell Method|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR was calculated using the Nankivell formula. GFR by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male or 25 for female). A normal GFR is greater than (>)90 mL/min per 1.73 m^2 [mL/min/1.73 m^2], although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<)15 mL/min/1.73 m^2 indicated kidney failure.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.||mL/min/1.73 m^2||Standard Deviation|Mean
30237|NCT01601821|Secondary|Creatinine Clearance|Creatinine clearance (CCr) is a measure of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 millimeters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.||mL/min||Standard Deviation|Mean
30238|NCT01601821|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 milligram per deciliter (mg/dL) for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.||mg/dL||Standard Deviation|Mean
30239|NCT01601821|Primary|Incidence of Efficacy Failure|Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported.|Baseline up to Month 12|Per-protocol 1 (PP1) population included all participants who had completed study, also included those who dropped out of study due to occurrence of death, graft loss, or biopsy-confirmed acute rejection and had no major protocol deviations.||percentage of participants|||Number
30240|NCT01601782|Primary|Accuracy of 3D Ultrasound Scanning|5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan. Both scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. We found in every case that there was no value so we immediately scrapped the project.|Up to 13 minutes|||participants|||Number
30241|NCT01601782|Primary|Volume Imaging Assessment|"Determine if volume imaging can accurately diagnose muscle, bone and tendon injuries when compared to conventional x-ray scan.~The goal of the study is to determine if a diagnosis can be provided by reviewing a 3D data set of ultrasound images that are focused at a patient's site of maximal symptoms. The hypothesis was whether this simple technique using innovative 3D imaging could replace the more time-consuming manual scanning of a patient's extremity."|2 weeks||||||
30242|NCT01601691|Secondary|Rectum Radiation Dose|Rectum dose will be calculated based on CT scans after brachytherapy.|1 day, 4 weeks, 8 weeks||||||
30243|NCT01601691|Secondary|Side Effects|Possible side effects will be collected by subject interview and physical examination on specified time frame.|1 day, 4 weeks, 8 weeks, 12 weeks||||||
30244|NCT01601691|Primary|Spacer Volume Half Life|Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.|1 day, 4 weeks, 8 weeks, up-to 16 weeks|||days||Standard Deviation|Mean
30245|NCT01601470|Secondary|Adverse Events, Serious Adverse Events and Deaths Were Monitored From Screening to End of Study|Number of patients with adverse events, serious adverse events and death|From the screening visit until 30 days past the final study assessment|Safety Analysis Set: This set included participants who received at least one dose of study drug.||Participants|||Number
30246|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil will be assessed. 8pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||hours||Full Range|Median
30247|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration (Cmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||ng/mL||Standard Deviation|Mean
30248|NCT01601470|Primary|Terminal Elimination Half-life (T1/2) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. T1/2 is a mathematically-derived value from all measurements. T1/2 is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||hours||Standard Deviation|Mean
30249|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||h*ng/mL||Standard Deviation|Mean
30250|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||h*ng/mL||Standard Deviation|Mean
30251|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Tmax is a mathematically-derived value from all measurements. Tmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||hours||Full Range|Median
30252|NCT01601470|Primary|Minimum Plasma Concentration Following Drug Administration at Steady State (Cmin,ss) of LCZ696 Analytes (AHU377, LBQ696 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmin is a mathematically-derived value from all measurements. Cmin is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||ng/mL||Standard Deviation|Mean
30253|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmax is a mathematically-derived value from all measurements. Cmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||ng/mL||Standard Deviation|Mean
30254|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of LCZ696 Analytes|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.||h*ng/mL||Standard Deviation|Mean
30255|NCT01601132|Primary|Apparent Total Volume of Distribution (Vd/F) of Theophylline|Apparent total volume of distribution after oral administration, calculated as Dose /(AUC0-∞) * Apparent first-order elimination rate constant [Kel])|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||liters||Standard Deviation|Mean
30256|NCT01601132|Primary|Apparent Total Body Clearance (CL/F) of Theophylline|Apparent total body clearance after oral administration, calculated as Dose /(AUC0-∞).|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||liters/hour||Standard Deviation|Mean
30257|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||hours*μg/mL||Standard Deviation|Mean
30258|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time of the Last Quantifiable Concentration[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population||hours*μg/mL||Standard Deviation|Mean
30259|NCT01601132|Primary|Maximum Plasma Concentration (Cmax) of Theophylline|The maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after another single dose on Day 19 following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters.||μg/mL||Standard Deviation|Mean
30260|NCT01601132|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Theophylline|The time to each the maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after a single dose on Day 19, following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters. Patients with available data are included in the analysis.||hours||Full Range|Median
30261|NCT01600950|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus|AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.|||||
30262|NCT01600950|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus|Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.|||||
30263|NCT01600950|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)|tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.||hours (hr)||Full Range|Median
30264|NCT01600950|Secondary|Total Glucose Infused (Gtot)|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
30265|NCT01600950|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
30266|NCT01600950|Primary|Pharmacodynamics: Duration of Action of LY2963016 and Lantus|Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant’s blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received study drug during Periods 1 or 2. Participants were analyzed based on treatment they received. The numbers of participants censored were 7 for both LY2963016 and Lantus groups. Maximum duration of actions is based on participants who reached the end of action before 42 hours: 13 participants for both groups.||hours (hr)||Full Range|Median
30267|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS||percent change in saline signal||Standard Error|Mean
30268|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS||percent change in saline signal||Standard Error|Mean
30269|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule|"Scans will be analyzed for task-related prefrontal activation~Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)"|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS||percent change in saline signal||Standard Error|Mean
30270|NCT01600729|Primary|Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Intra-rater (within raters) agreement of the FWS-A scores (0=none; 1=mild; 2=moderate; 3=severe) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 65 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale at 2 different time-points on Day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for WKS was provided.|Day 1|Participants from the Reliability population (all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1) who had 2 assessments on Day 1 available for analysis.||Kappa statistics||95% Confidence Interval|Mean
30271|NCT01600729|Primary|Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|Reliability population included all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1.||Kappa statistics||95% Confidence Interval|Mean
30272|NCT01600716|Other Pre-specified|Duration of Treatment Effect Through Week 52|The duration of treatment effect is the time to patient request for retreatment.|Up to 52 Weeks|Intent-to-Treat Population: all randomized patients||Weeks||95% Confidence Interval|Median
30273|NCT01600716|Secondary|Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points||Scores on a Scale||Standard Deviation|Mean
30292|NCT01600287|Other Pre-specified|Induction Time|Time required for the first time achievement of two subsequent BIS values below or equal to 55|10 minutes|||seconds||Standard Deviation|Mean
30274|NCT01600716|Secondary|Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)|Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points||Centimeters of Water (cm H2O)||Standard Deviation|Mean
30275|NCT01600716|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points||Milliliters (mL)||Standard Deviation|Mean
30276|NCT01600716|Primary|Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes|Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).|Baseline, Week 6|Intent-to-Treat Population: all randomized patients||Episodes||Standard Deviation|Mean
30277|NCT01600703|Secondary|Apolipoprotein B100 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B100 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours|||mg/kg/day||Standard Error|Mean
30278|NCT01600703|Primary|Apolipoprotein B48 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B48 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours|||ug/kg/day||Standard Error|Mean
30279|NCT01600677|Secondary|Hospital Readmission Rates|Determine the percentage of patients that are readmitted to the hospital within 30 days of discharge|30 day|||% readmissions|||Number
30280|NCT01600677|Secondary|Medication-reconciliation Errors During Transition From Hospital to Home|Using the previously validated and reliable medication discrepancy tool (MDT)|90-day|||Participants with errors|||Number
30281|NCT01600677|Primary|Medication Adherence|Will be measured by: (number of doses/ doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts (control))|90-day|||percentage of medication adherence||Standard Deviation|Mean
30282|NCT01600495|Secondary|Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.|Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.|10 hours|All patients were invited to answer the questionnaire.||participants|||Number
30283|NCT01600495|Secondary|Duration From Start of Labor Until Birth|The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.|10 hours|Analyzing the duration of labor||min||Standard Deviation|Mean
30284|NCT01600495|Secondary|Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia|Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.|10 hours|Analyzing the date of application of pharmacological analgesia.||cm||Standard Deviation|Mean
30285|NCT01600495|Primary|Classification of Pain During Labor by Visual Analogue Scale|"To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.~Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled no pain associated with a score of 0 mm and at the other end worst pain imagined with a score 100 mm)"|30 minutes|We evaluated 46 patients, divided into 23 ENT group and 23 in the control group.||mm||Standard Deviation|Mean
30286|NCT01600287|Other Pre-specified|Number of Times Rate of Propofol Changed Manually|Number of times rate of propofol needed to be changed manually|8 hours(aprrox)|||times per hour||Full Range|Median
30287|NCT01600287|Other Pre-specified|Total Off CPB Propofol Used (mg/kg/hr|total dosage of propofol used on per kg body weight per hour basis in the period before and after cardiopulmonary bypass period.|6 hours(approx)|||mg per kg body weight per hour||Standard Deviation|Mean
30288|NCT01600287|Other Pre-specified|Total Fentanyl Used (µg/kg)|total fentanyl used in the whole duration of surgery on per kg body weight basis|8 hours(approx)|||microgram per kg body weight||Standard Deviation|Mean
30289|NCT01600287|Other Pre-specified|Total Propofol Used (mg/kg/hr)|total propofol used based on per kg body weight per hour for the whole duration of surgery|8 hours (approx)|||mg per kg body weight per hour||Standard Deviation|Mean
30290|NCT01600287|Other Pre-specified|Percentage Fall in MAP During Induction|percentage fall in mean arterial pressure from baseline during induction|15 minutes|||percentage of fall from baseline||Standard Deviation|Mean
30291|NCT01600287|Other Pre-specified|Minimum BIS During Induction|Bispectral Index(BIS) is an EEG-based objective measure of anesthetic depth with values ranging from 100 to 0, lower number indicating greater depth of anesthesia. Values between 40 to 60 indicate adequate depth required for surgery. During induction of anesthesia, there is a tendency of overshooting the adequate depth of anesthesia, due to use of higher dose and rate of administration required for induction. The minimum BIS achieved during induction is a measure of this overshoot. The less the minimum value, the more is the overshoot, worse the outcome is. The minimum BIS during induction is automatically stored in the PC used for the study.|15 minutes|||Bispectral Index||Standard Deviation|Mean
30298|NCT01600287|Secondary|Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|Approximately 8 hours|||percentage of time||Standard Deviation|Mean
30299|NCT01600287|Secondary|Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline|The duration of time heart rate remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|Approximately 8 hours|||percentage of time||Standard Deviation|Mean
30300|NCT01600287|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|Approximately 8 hours|||errors per participant||Standard Deviation|Mean
30301|NCT01600287|Secondary|Median Absolute Performance Error(MDAPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_).The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|Approximately 8 hours|||errors per participant||Standard Deviation|Mean
30302|NCT01600287|Secondary|Median Performance Error(MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during propofol anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|Approximately 8 hours|||errors per participant||Standard Deviation|Mean
30303|NCT01600287|Primary|Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target|The primary outcome to be measured is the ability of the system to keep the depth of anesthesia in the target range, i.e, Bispectral Index(BIS) value of 50+/- 10. This will assess the ability of the system to prevent intra-operative awareness of the patients and at the same time avoid excessive depth of anesthesia with its accompanying adverse effects.|Approximately 8 hours|||percentage of time||Standard Deviation|Mean
30304|NCT01600222|Secondary|Efficacy Evaluation|The percentage of subjects who achieved ‘controlled disease’ (i.e., Clear or Almost clear) according to the Investigator’s Global Assessment (IGA) of disease severity on the trunk, limbs and scalp at Days 28 (Visit 3) and End of treatment (EoT) were presented.|4 weeks I 28 days and End of treatment|"The percentage of subjects achieving controlled disease on Day 28 (n=35) was calculated from the full analysis set.~The percentage of subjects achieving controlled disease at End of Treatment (n=37) was was calculated from the full analysis set using a last observation carried forward approach."||percentage of subjects|||Number
30305|NCT01600222|Secondary|Pharmacokinetic Evaluation T1/2|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||h||Full Range|Mean
30306|NCT01600222|Secondary|Pharmacokinetic Evaluation Tmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Tmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||h||Full Range|Median
30307|NCT01600222|Secondary|Pharmacokinetic Evaluation AUCinf|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||pg/ml||Full Range|Mean
30308|NCT01600222|Secondary|Pharmacokinetic Evaluation AUClast|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol AUClast are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations||pg/ml||Full Range|Mean
30309|NCT01600222|Secondary|Pharmacokinetic Evaluation Cmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Cmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations.||pg/ml||Full Range|Mean
30310|NCT01600222|Secondary|Number of Subjects Who Discontinued From the Study|Number of subjects who discontinued from the study due to adverse events.|Baseline to Day 28|||participants|||Number
30311|NCT01600222|Secondary|Change in Heart Rate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (heart rate).|Baseline and Day 28|||beats/min||Standard Deviation|Mean
30312|NCT01600222|Secondary|Change in Blood Pressure From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (blood pressure).|Baseline and Day 28|||mmHg||Standard Deviation|Mean
30313|NCT01600222|Secondary|Change in Plasma Parathyroid Hormone (PTH) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in plasma PTH from Baseline to Day 28.|Baseline and Day 28|||pmol/L||Standard Deviation|Mean
30314|NCT01600222|Secondary|Change in Serum Alkaline Phosphatase (ALP) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum ALP from Baseline to Day 28.|Baseline and Day 28|||IU/L||Standard Deviation|Mean
30315|NCT01600222|Secondary|Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary phosphate:creatinine ratio from Baseline to Day 28.|Baseline and Day 28|||mmol/g||Standard Deviation|Mean
30316|NCT01600222|Secondary|Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary phosphate excretion from Baseline to Day 28.|Baseline and Day 28|||mmol/24H||Standard Deviation|Mean
30317|NCT01600222|Secondary|Change in Serum Phosphate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum phosphate from Baseline to Day 28.|Baseline and Day 28|||mmol/L||Standard Deviation|Mean
30318|NCT01600222|Secondary|Number of Participants With an Adverse Drug Reaction (ADR)|Adverse drug reactions (ADRs) were defined as adverse events for which the investigator has not described the causal relationship to investigational medication as “not related”.|Baseline to Day 28|||participants|||Number
30319|NCT01600222|Secondary|Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28|Serum cortisol concentrations at 30 and 60 minutes after injection were measured in order to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration is ≤18mcg/dl at 30 minutes after the injection.|Day 28|||Subjects|||Number
30320|NCT01600222|Primary|Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary calcium:creatinine ratio from Baseline to Day 28.|Baseline and Day 28|||mmol/g||Standard Deviation|Mean
30321|NCT01600222|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary calcium excretion from Baseline to Day 28 in 24-hour.|Baseline and Day 28|||mmol/24H||Standard Deviation|Mean
30322|NCT01600222|Primary|Change in Albumin-corrected Serum Calcium From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in albumin-corrected serum calcium from Baseline to Day 28.|Baseline and Day 28|||mmol/L||Standard Deviation|Mean
30323|NCT01600222|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge)|HPA-axis testing by means of the rapid standard-dose cosyntropin test (ACTH-challenge test) for detection of adrenal suppression.|Day 28|Per protocol analysis set.||Subjects|||Number
30324|NCT01599104|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|8 weeks|Safety Set. The safety set included aqll participants who had received study medication.||Participants|||Number
30325|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure|Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
30326|NCT01599104|Secondary|Change From Baseline in Office Pulse Pressure|Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||mmHg||Standard Error|Least Squares Mean
30327|NCT01599104|Secondary|Change From Baseline in maSBP and maDBP for Daytime/Nighttime|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
40560|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|Self-report measure of depressive symptoms|change in QIDS score from baseline to 1 month posttreatment||||||
30328|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
30329|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msDBP Response|Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||Percentage of participants|||Number
30330|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msSBP Response|Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||Percentage of participants|||Number
30331|NCT01599104|Secondary|Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||Percentage of participants|||Number
30332|NCT01599104|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.||mmHg||Standard Error|Least Squares Mean
30333|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8|Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.||mmHg||Standard Error|Least Squares Mean
30334|NCT01599104|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments.||mmHg||Standard Error|Least Squares Mean
30335|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set||Percentages|||Number
30336|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set||Percentages|||Number
30337|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set||Percentages|||Number
30338|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set||Percentages|||Number
30339|NCT01598987|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 24|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 24.|Baseline, Month 24|Full analysis set||mL/min/1.73m2||Standard Deviation|Mean
30340|NCT01598987|Secondary|Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints|"The proportion of patients with composite efficacy failure (treated biopsy proven acute rejection[tBPAR], graft loss [GL] , death [D]) before/at Month 12 and Month 24, estimated with Kaplan-Meier (KM) methods and the proportion of patients who experienced any of the components of composite efficacy failure (tBPAR, GL, D) before/at Month 12 and Month 24, separately for each component.~AR: acute rejection; BPAR: biopsy proven acute rejection. Rate = Kaplan-Meier estimate for failure in %; CI = confidence interval for failure rate."|At 12-month and 24-month after start of study drug|Full Analysis Set||Percentages||80% Confidence Interval|Number
30341|NCT01598987|Primary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 12|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.|Baseline, Month 12|Full Analysis Set||mL/min/1.73m^2||Standard Deviation|Mean
30342|NCT01600092|Secondary|Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||Baseline and 42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint||Percentage of participants||95% Confidence Interval|Number
30343|NCT01600092|Secondary|Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint||Titer||95% Confidence Interval|Geometric Mean
30344|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Intussusception|The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception|Up to Day 185|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.||Participants|||Number
30345|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.|Up to 7 days after any vaccination (up to 147 days)|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.||Participants|||Number
30346|NCT01600092|Primary|Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint||Titer||95% Confidence Interval|Geometric Mean
30347|NCT01600053|Secondary|Recording of the Occurrence of Adverse Events||From date of first dose until the date of first documented progression or date of death from any cause, whichever came first|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Please see adverse event listing for additional information.||participants|||Number
30348|NCT01600053|Primary|Eradication of Residual Disease From the Marrow||From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Data were not collected from the 11 participants before study termination.|||||
30349|NCT01600014|Secondary|The Change in AK Count From Randomisation to 8 Weeks After Randomisation|The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups|8 weeks after randomisation|||AK count||Standard Deviation|Mean
30350|NCT01600014|Secondary|Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12|The analysis was done separately for the field recalcitrant subgroup, the field recurrent subgroup, and overall for all treated subject (Analysis 1, 2, and 3, respectively)|From last treatment cycle through to Month 12|||participants|||Number
30351|NCT01600014|Primary|Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation|The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)|8 weeks after randomisation|||participants|||Number
30352|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
30353|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
30354|NCT01599806|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
30355|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
30356|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
30357|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
30358|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30360|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30361|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30362|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30363|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30364|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
30365|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30366|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
30367|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
30368|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30369|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
30370|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30371|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30372|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30373|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
30374|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30375|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
30376|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
30377|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30378|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
30379|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30380|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30381|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30382|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)||Participants|||Number
30383|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
30384|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
30385|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30386|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
30387|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
30388|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30389|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
30390|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
30391|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30392|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)||Participants|||Number
32598|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - IL-6|Change in serum cytokine, IL-6 from Baseline to Final Visit|Baseline to end of treatment (10 week treatment period)|ITT analysis set||ng/L||Standard Deviation|Mean
30393|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)||Participants|||Number
30394|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))||Participants|||Number
30395|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
30396|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
30397|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))||Participants|||Number
30398|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
30399|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )||Participants|||Number
30400|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
30401|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30402|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30403|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30404|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
30405|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
30406|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participants|||Number
30407|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
30408|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participants|||Number
30409|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
30410|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30411|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30412|NCT01599806|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30413|NCT01599806|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30414|NCT01599806|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30415|NCT01599741|Secondary|Radiation Dose Measurements: Air Kerma (AK)|"Percentage dose change of ClarityIQ vs. AlluraXper in AK calculated by AK/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.~AK was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.||percentage of dose change||Standard Deviation|Mean
30416|NCT01599741|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|"Percentage dose change of ClarityIQ vs. AlluraXper in DAP calculated by DAP/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.~DAP was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.||percentage of dose change||Standard Deviation|Mean
30417|NCT01599741|Primary|Image Quality|Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used.|1 Day|All patients with recorded dose information from the system for both DSA runs were used.||Proportion of images rated equal/better||90% Confidence Interval|Mean
30418|NCT01599650|Secondary|BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)~-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Month 24|Randomized set||BCVA letters||Standard Deviation|Mean
30717|NCT01593592|Secondary|The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.|Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.|8 weeks|||participants|||Number
30419|NCT01599650|Secondary|The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.|Months 6 and 24|||score on a scale||Standard Deviation|Mean
30420|NCT01599650|Secondary|The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity & analysis was based on analysis of variance (ANOVA)|Month 12 and Month 24|||microns||Standard Error|Mean
30421|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.|Month 24|||participants|||Number
30422|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.|Month 6|||participants|||Number
30423|NCT01599650|Secondary|The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 & Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).|Baseline, Month 6 and Month 24|||percent patients gaining improvement|||Number
30424|NCT01599650|Secondary|The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.|Baseline, Month 12 and Month 24|Full Analysis set||letters||Standard Deviation|Mean
30425|NCT01599650|Secondary|Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.|From Baseline through Month 6|||letters||Standard Deviation|Mean
30426|NCT01599650|Secondary|Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group|Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.|Day 1 through Month 23|||treatments||Standard Deviation|Mean
30427|NCT01599650|Secondary|The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.|Baseline, 24 Months|analysis for change consists of the group that had a baseline and 24 month data point||letters||Standard Deviation|Mean
30428|NCT01599650|Primary|Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)~-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Baseline, 6 Months|analysis for change consists of the group that had a baseline and 6 month data point||letters||Standard Deviation|Mean
30429|NCT01599637|Secondary|Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment|The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||score||Standard Deviation|Mean
30430|NCT01599637|Secondary|Skindex-29 by Treatment|The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients’ quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||Score||Standard Deviation|Mean
30431|NCT01599637|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.|Baseline through Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||Score||Standard Deviation|Mean
30432|NCT01599637|Secondary|Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment||Day 29 to Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||Percentage of days||Standard Deviation|Mean
30433|NCT01599637|Secondary|Likert Scale-Physician’s and Patients In-clinic Global Assessment by Treatment|The investigator or the person he or she designated and the patient provided scoring of the patient’s global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient’s condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data||score||Standard Deviation|Mean
30434|NCT01599637|Secondary|Change From Baseline in Urticaria Activity Score (UAS7)|Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data. If the Week 12 value was missing, it was imputed as the last available UAS7 value (LOCF).||units on a scale||Standard Deviation|Mean
30435|NCT01599637|Secondary|Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit||Baseline through Day 140|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||IU/mL||Standard Deviation|Mean
30436|NCT01599637|Secondary|Mean (SD) Serum Free IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||% change||Standard Deviation|Mean
30437|NCT01599637|Secondary|Mean (SD) Serum Free IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||ng/mL||Standard Deviation|Mean
30438|NCT01599637|Secondary|Mean (SD) Serum Total IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||Percent Change from Baseline||Standard Deviation|Mean
30439|NCT01599637|Secondary|Mean (SD) Serum Total IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||ng/mL||Standard Deviation|Mean
30440|NCT01599637|Secondary|Serum Levels of Omalizumab|Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks|Baseline through Day 85|PK analysis set which included all subjects who received at least one dose of study drug and had evaluable IGE025 concentrations.||ng/mL||Standard Deviation|Mean
30441|NCT01599637|Secondary|Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set|The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis||# positive cells||Standard Deviation|Mean
30450|NCT01599325|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||Liters||Geometric Coefficient of Variation|Geometric Mean
30451|NCT01599325|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||Liters/hours||Geometric Coefficient of Variation|Geometric Mean
30442|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.• FACS parameters: FceRI expression on basophils and IgE bound, FceR2 expression on B cells and IgE bound, and FceRI expression on dendritic cells||Flourescence units||Standard Deviation|Mean
30443|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||% out of leukocytes||Standard Deviation|Mean
30444|NCT01599637|Secondary|Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.||ug/mL||Standard Deviation|Mean
30445|NCT01599637|Secondary|Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit|The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline to Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Day 29 was an optional sampling time point in this paramter. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2||# positive cells||Standard Deviation|Mean
30446|NCT01599637|Secondary|Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.||correlation coefficient|||Number
30447|NCT01599637|Secondary|Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.||correlation coefficient|||Number
30448|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis||IgE positive skin cells||Standard Deviation|Mean
30449|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis||FcεRI positive skin cells||Standard Deviation|Mean
30452|NCT01599325|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||hours||Geometric Coefficient of Variation|Geometric Mean
30453|NCT01599325|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||hours||Full Range|Median
30454|NCT01599325|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
30455|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
30456|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation will be performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ will not be reported|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
30457|NCT01599325|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A treatment-emergent adverse events (TEAE) was defined as AEs with an onset date on or after the date of first dose and within 28 days after the date of the last dose. Any AE that occurred beyond this timeframe and was assessed by the investigator as possibly related to study drug was considered treatment-emergent. The intensity and severity of AEs was assessed by the investigator according to the Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. For any AEs not listed in the CTCAE grading system, the intensities of these events was assessed by the Investigator using the 5-point scale: Grade 1 = Mild, Grade 2 = Moderate; Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. An SAE is any AE occurring that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and constitutes an important medical event.|Up to 29 January 2015; from the first dose of study drug to 28 days after the date of the last dose of study drug (maximum time on study was 244 days)|Safety population included all participants who received at least one dose of azacitidine and had at least one post-dose safety assessment||participants|||Number
30458|NCT01599325|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|Overall survival is defined as time to death from any cause, is calculated using date of first dose and date of death, or date of last follow-up for censored participants. Those, who die regardless of the cause of death, will be considered to have an event.|Until the end of the survival follow-up period; Up to data cut-off of 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||months||95% Confidence Interval|Number
30459|NCT01599325|Secondary|The Number of Infections (Post-baseline Average) Requiring Intravenous (IV) Antibiotics, Anti-fungals, or Antivirals by Cycle|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||Infections||Standard Deviation|Mean
30460|NCT01599325|Secondary|The Number of RBC Transfusions by Cycle|The number of RBC transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||RBC Transfusions||Standard Deviation|Mean
30461|NCT01599325|Secondary|The Number of Units of Red Blood Cell (RBC) Transfusions by Cycle|The number of units of RBC received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for RBC. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|ITT includes all participants who were enrolled into the study||Units of RBC Transfusions||Standard Deviation|Mean
30718|NCT01593592|Secondary|Severe Adverse Effects to the Used Medications and Dietary Supplements.||4 weeks|||percentage of participants|||Number
30462|NCT01599325|Secondary|The Number of Platelet Transfusions by Cycle|The number of platelet transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||Platelet transfusions||Standard Deviation|Mean
30463|NCT01599325|Secondary|The Number of Units of Platelet Transfusions by Cycle|The number of units of platelet transfusions received 56 days prior to treatment, considered the baseline period, (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||Units of platelet transfusions||Standard Deviation|Mean
30464|NCT01599325|Primary|Percentage of Participants Achieving a Hematologic Improvement (HI) Based on 2000 IWG Response Criteria for MDS and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic improvements (HI) have 4 categories: 1. Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor: 10-20g/L increase or ≥50% decrease in transfusion requirements. 2. Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor: ≥50% increase. 3. Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor: ≥100% increase and absolute increase of <0.5x10^9/L 4. Progression or relapse after HI Hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor's determination was derived using clinically relevant data. Denominator for progression/relapse after HI included participants who had achieved HI.|Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
30465|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Using IWG Criteria for MDS and Assessed by the Investigator|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
30466|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Based on the International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
30467|NCT01599234|Secondary|Number of Subjects With a 50% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 50% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 50% level is presented."|0 - 15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
30494|NCT01598532|Primary|Stroop Test for Executive Function - Trial 4 Inhibition Switching|Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment|All participants enrolled in Transcranial LED Treatment Group||# of SD Units||Standard Deviation|Mean
32599|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - Interleukin (IL)-2|Change in serum cytokine IL-2 from Baseline to Final Visit|Baseline to end of treatment (10 week treatment period)|ITT analysis set||ng/L||Standard Deviation|Mean
30468|NCT01599234|Secondary|Change From Baseline in the Mean Total Barthel Activities of Daily Living Index Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The scores for each of the items are summed to create a total score of 100. An increase in score indicates an improvement.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
30469|NCT01599234|Secondary|Carer Global Impression of Change at the End of Treatment|The carer of the subject gave their opinion of any noticeable change in the subject’s overall functional ability at the end of the study. A 7-point Likert-type scale was used, with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of carers who reported an improvement at the end of treatment is presented.|Day 99 (end of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set as a result of no on-treatment efficacy data||participants|||Number
30470|NCT01599234|Secondary|Change From Baseline in Mean Timed 10 Metre Walk Time at the End of Treatment|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||time (seconds)||Standard Deviation|Mean
30471|NCT01599234|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced and adverse event during the course of the study is presented|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set (used for the efficacy analysis) as a result of no on-treatment efficacy data||participants|||Number
30472|NCT01599234|Secondary|Change From Baseline in Mean Sleep Quality 0-10 NRS During the Last 14 Days of Treatment (End of Treatment)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate how your spasticity disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
30473|NCT01599234|Secondary|Change From Baseline in the Mean Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
30474|NCT01599234|Secondary|Number of Subjects With a 30% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 30% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 30% level is presented."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
30475|NCT01599234|Primary|Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)|"The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
30476|NCT01598779|Primary|Human Papillomavirus (HPV) Types in External Genital Warts (EGW)|150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type|4 months|Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, All biopsies were analyzed to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.||percentage of participants|||Number
30477|NCT01598740|Secondary|Change in Fecal Weight|Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)|||grams||Standard Deviation|Mean
30478|NCT01598740|Primary|Change in Fecal Sodium Content|Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)|||mg||Standard Deviation|Mean
30479|NCT01598610|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|Per protocol||participants|||Number
32600|NCT01562314|Secondary|Clinical Efficacy Blood Sample Measurements - C Reactive Protein (CRP)|Change in serum CRP from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||mg/L||Standard Deviation|Mean
30480|NCT01598610|Secondary|Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|217 (220-3) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 1 subject.||percentage of BG Test Results|||Number
30481|NCT01598610|Secondary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma) of the reference method results.|1 hour|108 (110-2) blood test results from one test strip lot were analyzed. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick result was obtained for 1 subject.||percentage of BG Test Results|||Number
30482|NCT01598610|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Venipuncture was unsuccessful for 6 subjects. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method.||percentage of BG Test Results|||Number
30483|NCT01598610|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Four(4) subjects had low blood sugar and AST results were not evaluable per protocol. One(1) subject with low blood sugar (AE) did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.||percentage of BG Test Results|||Number
30484|NCT01598610|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|216 (220-4) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 2 subjects.||percentage of BG Test Results|||Number
30485|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|24 hours after intrathecal injection|||units on a scale||Full Range|Mean
30486|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|18 hours after intrathecal injection|||units on a scale||Full Range|Mean
30487|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|6 hours after intrathecal injection|||units on a scale||Full Range|Mean
30488|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline|||units on a scale||Full Range|Mean
30489|NCT01598545|Primary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|12 hours after intrathecal injection|||units on a scale||Full Range|Mean
30490|NCT01598532|Primary|Digit Span, Forwards and Backwards|Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group||# of SD units||Standard Deviation|Mean
30491|NCT01598532|Primary|Controlled Oral Word Association Test (FAS)|Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group||# of SD units||Standard Deviation|Mean
30492|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in Transcranial LED Treatment Group||# of SD Units||Standard Deviation|Mean
30493|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5|California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment|All participants enrolled in Real Intervention Group||# of SD Units||Standard Deviation|Mean
40561|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report measure of the intensity of PTSD symptoms|change in PCL score from baseline to 3 months posttreatment||||||
30495|NCT01598532|Primary|Stroop Test for Executive Function - Trial 3 - Inhibition|Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-month and 2-months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group||# of SD units||Standard Deviation|Mean
30496|NCT01598506|Secondary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|30 minutes after intrathecal injection|||units on a scale||Full Range|Mean
30497|NCT01598506|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline|||units on a scale||Full Range|Mean
30498|NCT01598506|Primary|Change in Pain Score|Change in pain score was calculated by subtracting the 30 minute pain score from the baseline pain score.The pain scores were on a continuous visual analogue scale of 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline, 30 minutes|||units on a scale||Full Range|Mean
30499|NCT01598428|Secondary|Refractive Error|auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively|||diopter(D)|Participants|Standard Deviation|Mean
30500|NCT01598428|Secondary|Uncorrected Visual Acuity(UCVA)|The UCVA was recorded in logMAR units at each vist|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively|||logMAR|Participants|Standard Deviation|Mean
30501|NCT01598428|Primary|Effective Lens Position|Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.|1 day，1 week, 1 month，3 months and 6 months postoperatively|||mm|Participants|Standard Deviation|Mean
30502|NCT01598350|Primary|Step Width||60 minutes|||cm||Standard Deviation|Mean
30503|NCT01598129|Primary|Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities|No Dose Limiting Toxicities were observed at any dose level.|6 months|||Dose limiting toxicities|||Number
30504|NCT01598129|Other Pre-specified|Number of Patients With Induction of Tumor-specific CD8+ T Cells in Peripheral Blood Monomuclear Cells.||6 months|||participants|||Number
30505|NCT01598129|Other Pre-specified|Number of Participants With Infiltration of CD8+ T Cells Into Tumors.||6 months|||participants|||Number
30506|NCT01598129|Other Pre-specified|An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.||6 hours|||participants|||Number
30507|NCT01598129|Other Pre-specified|Quality of Life Using EORTC QLQ-C30.|To assess the feasibility and usefulness of EORTC QLQ-C30 for possible use in later studies.|12 months||||||
30508|NCT01598129|Other Pre-specified|Number of Participants With Stable Disease Status as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Evaluation Three Months After Starting CGTG-102 Treatment.||3 months|||participants|||Number
30509|NCT01598129|Secondary|To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.|Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.|12 months||||||
30510|NCT01598129|Primary|Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.||6 months|||participants|||Number
30511|NCT01598064|Secondary|Liver Function Evaluation|Measure ALT level of patients|8 weeks|||U/L||Standard Deviation|Mean
30512|NCT01598064|Primary|Admission Due to Complications Related to Portal Hypertension||8 weeks|||participants|||Number
30513|NCT01597908|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data are summarized per RECIST, Version 1.1.|From the first documented evidence of a CR or PR until the earliest date of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Only those participants with a confirmed response (CR and PR) were analyzed. Participants with measurable and non-measurable disease were analyzed.||Months||95% Confidence Interval|Median
30514|NCT01597908|Secondary|Overall Response, as Assessed by the Investigator|Overall response is defined as the number of responders (complete response [CR] + partial response [PR] per RECIST, Version 1.1) as summarized by Investigator assessment. CR is defined as the disappearance of all evidence of target lesions. PR is defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data are reported as those participants with measureable disease.|Screening, Week 8 and every 8 weeks thereafter through Week 56, and then every 12 weeks|ITT Population||Participants|||Number
30515|NCT01597908|Secondary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|From randomization to the first documented occurrence of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Participants who did not progress or die or who progressed or died after the start of new anti-cancer therapy or after an extended period without adequate assessment were censored at their date of last adequate assessment prior to progression or death even if subsequent information was available regarding progression or death.||Months||95% Confidence Interval|Median
30516|NCT01597908|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death due to any cause (up to Study Week 92)|Intent-to-Treat (ITT) Population: all randomized participants, whether or not study medication was administered. All participants in the ITT Population were analyzed. For participants who did not die, time of death was censored at the date of last contact.||Months||95% Confidence Interval|Median
30517|NCT01597843|Primary|Registration for MHV|Measured by response to question: Have you ever used My HealtheVet online?|Baseline; After Group 1 Intervention; After Group 2 Intervention|Respondents to first round survey||Percentage of respondents who use MHV|||Number
30518|NCT01597596|Secondary|Change From Baseline in Motor Development Status at Week 52|Motor development status was assessed by the Gross Motor Function Measure - 88 Scale (GMFM-88) total percent scores. GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item was scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension was expressed as a percentage of the maximum score for that dimension. Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision.||percentage of maximum total score||Standard Deviation|Mean
30519|NCT01597596|Secondary|Number of Participants With Invasive Ventilator-Free Survival|Invasive ventilator-free survival was defined as the time during which the participant is alive and not invasively ventilated. Number of Participants with invasive ventilator-free survival were reported.|Up to Week 52|Full analysis population.||participants|||Number
30520|NCT01597596|Secondary|Percentage of Participants With Estimated Probability of Survival||Up to Week 52|Full analysis population.||percentage of participants|||Number
30521|NCT01597596|Primary|Change From Baseline in Cardiac Function at Week 52|Cardiac function was measured by the left ventricular mass Z-score (LVM-Z). Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline indicates an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population defined as all participants who receive at least 1 infusion of alglucosidase alfa. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision||Z-score||Standard Deviation|Mean
30522|NCT01597492|Primary|Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination|A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28.|Four weeks after vaccination|As-treated Population: all participants who received at least one dose of belimumab. All analyses of vaccine titers were performed on the As-treated Population.||Participants|||Number
30523|NCT01597479|Secondary|Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron|Number of participants with Maximum pain intensity NVS > 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty||participants|||Number
30524|NCT01597479|Primary|Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day|Pain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty (TRA)||percentage of patients|||Number
30525|NCT01597245|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the # of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received at least 1 dose of study treatment and had evaluable data.||percentage of participants|||Number
30526|NCT01597245|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 75%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps involvement at baseline. Participants who did not meet clinical response criteria or have missing data will be considered non-responders.||percentage of participants|||Number
30583|NCT01596062|Primary|Saturation Rate of CD25 Antigen Saturation by Basiliximab|CD25 saturation is the percentage of T cells expressing CD25|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||percentage of T cells||Standard Deviation|Mean
30527|NCT01597245|Secondary|Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. LS mean change from baseline in patient's global assessment of disease severity score was calculated using (MMRM) with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects."|Baseline, 12 weeks|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline PatGA measurement.||units on a scale||Standard Error|Least Squares Mean
30528|NCT01597245|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean change from baseline in SF-36 score was calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline SF-36 measurement. Missing data was imputed by last observation carried forward ( LOCF ).||units on a scale||Standard Error|Least Squares Mean
30529|NCT01597245|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The (WPAI-PSO) is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days and has four domains, namely, absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as each score * 100 and ranges from 0 to 100; greater scores indicate greater impairment. LS mean change from baseline in each WPAI-PSO score was calculated using the (ANCOVA) model with treatment, pooled center and baseline WPAI value.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline WPAI-PSO measurement. Missing data was imputed by last observation carried forward ( LOCF ).||units on a scale||Standard Error|Least Squares Mean
30530|NCT01597245|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean change from baseline in total QIDS-SR16 score was calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline QIDS-SR16 measurement. Missing data was imputed by last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
30531|NCT01597245|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis|The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean change from baseline in BSA was calculated using MMRM with baseline BSA as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.||units on a scale||Standard Error|Least Squares Mean
30532|NCT01597245|Secondary|Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 (less severity) to 72 (more severity), with lower scores indicating less severity. LS mean change from baseline in PSSI score was calculated using MMRM with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps involvement at baseline and at least 1 post-baseline PSSI measurement. Missing data was imputed by last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
30533|NCT01597245|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps. The fingernail bed and fingernail matrix are each divided into quadrants. Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. The NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80 with higher scores indicating more severe Ps. LS mean change from baseline in NAPSI score was calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps involvement at baseline and at least 1 post-baseline NAPSI measurement.||units on a scale||Standard Error|Least Squares Mean
40562|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report measure of the intensity of PTSD symptoms|change in PCL score from baseline to 1 month posttreatment||||||
30534|NCT01597245|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much); and not relevant and unanswered responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life impairment. A 5-point change from baseline is considered clinically relevant. Least Squares (LS) Mean change from baseline was calculated using mixed model repeated measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and who had baseline and at least 1 post-baseline DLQI measurement.||units on a scale||Standard Error|Least Squares Mean
30535|NCT01597245|Secondary|Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline|"The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. The number and percentage of participants achieving an Itch NRS ≥4 point reduction from baseline were presented by treatment group for participants who had a baseline Itch NRS ≥4. Describes worst level of itching in past 24 hours."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and had Itch NRS ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
30536|NCT01597245|Secondary|Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|All randomized participants who had sPGA score of (0,1) at Week 12, were re-randomized at Week 12 and received at least 1 dose of study treatment in the Maintenance Dosing Period. Participants who did not meet the clinical response criteria or had missing data at Week 60 were considered non-responders for Non-Responder Imputation (NRI) analysis.||Percentage of participants|||Number
30537|NCT01597245|Secondary|Percentage of Participants Achieving PASI 100% (PASI100)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
30538|NCT01597245|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 were defined as having an improvement of ≥90% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
30539|NCT01597245|Secondary|Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant’s Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
30540|NCT01597245|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
40672|NCT01447914|Secondary|Duration of Response|Kaplan and Meier product limit methods will be used to estimate the DOR with 95% confidence intervals.|From first observation of partial response to the time of disease progression, assessed up to 30 days||||||
30541|NCT01597245|Primary|Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of “0” or “1” with at least a 2-point improvement from baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
30542|NCT01597141|Secondary|Functioning|Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.|24 months|15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study.||units on GAF scale||Standard Deviation|Mean
30543|NCT01597141|Primary|Onset of Psychosis|Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.|From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months|||percentage of sample converting|||Number
30544|NCT01597050|Primary|Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.|Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.|Up to Week 4|Per-protocol population all patients who had no major protocol deviations and were present at all scheduled visits up to and including Week 4.||percentage of subjects|||Number
30545|NCT01596972|Secondary|Patient Satisfaction With Each Follow-up Method|"Patient satisfaction with each follow-up method was assessed with the following survey questions:~How satisfied are you with [name of follow-up method]? (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)"|1 week|||participants|||Number
30546|NCT01596972|Secondary|Patient Compliance With Each Follow-up Method||2 weeks|||participants|||Number
30547|NCT01596972|Primary|Number of Women in Each Group Who Require a Return Visit to the Clinic for a Serum hCG Measurement, Ultrasound or Clinical Examination at One Week to Confirm Complete Evacuation||1 week|The number of participants analyzed in the serum hCG arm were the number of participants who started in this arm minus the number who were discontinued from the study per MD decision (total N in analysis was therefore 17).||participants|||Number
30548|NCT01596842|Secondary|Changes of Phosphate Binder Doses||4 weeks, 8 weeks and 12 weeks||||||
30549|NCT01596842|Secondary|Changes of Erythropoietin Doses||4 weeks, 8 weeks and 12 weeks||||||
30550|NCT01596842|Secondary|Changes of Phosphorous Levels||4 weeks, 8 weeks and 12 weeks||||||
30551|NCT01596842|Secondary|Change of FGF-23 Levels||12 weeks||||||
30552|NCT01596842|Secondary|Change of Fetuin-A Levels||12 weeks||||||
30553|NCT01596842|Secondary|Change of Intact Parathyroid Hormone||12 weeks||||||
30554|NCT01596842|Secondary|Changes of Calcium Levels||4 weeks, 8 weeks and 12 weeks||||||
30555|NCT01596842|Secondary|Hemoglobin Levels at 12 Weeks||12 weeks|||g/dL||Standard Deviation|Mean
30556|NCT01596842|Primary|25-hydroxyvitamin D Levels at 12 Weeks||12 weeks|||ng/ml||Standard Deviation|Mean
30557|NCT01596504|Secondary|Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast|Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately.|0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed=participants with appetite perception assessment at specified time-points.||mm||Standard Deviation|Mean
30558|NCT01596504|Secondary|Change From Baseline to Day 57 in Waist Circumference||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57|PD population. Number of participants analyzed = participants with waist circumference assessment at specified time-points.||cm||Standard Deviation|Mean
30559|NCT01596504|Secondary|Change From Baseline to Day 57 in Body Weight||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57|PD population. Number of participants analyzed = participants with body weight assessment at specified time-points.||kg||Standard Error|Least Squares Mean
30560|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure|The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with blood pressure assessment at specified time-points.||mmHg||Standard Deviation|Mean
30604|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30561|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate|The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with heart rate assessment at specified time-points.||beats per minute||Standard Error|Least Squares Mean
30562|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Coefficient|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying.|0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed = participants with gastric emptying at specified time-points.||coefficient (unit-less)||Standard Deviation|Mean
30563|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry.|0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed=participants with gastric emptying assessment at specified time-points.||minutes (min)||Standard Error|Least Squares Mean
30564|NCT01596504|Secondary|Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose||Day -7 (Baseline), Day 56|PD population. Number of participants analyzed=participants with insulin glargine dose assessment at specified time-points.||units||Standard Deviation|Mean
30565|NCT01596504|Secondary|Change From Baseline to Day 56 in HbA1c|HbA1C was assessed using the high performance liquid chromatography method.|Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56|Number of participants analyzed = participants with HbA1c assessment at specified time-points.||percentage of HbA1c||Standard Error|Least Squares Mean
30566|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours|Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with glucagon assessment at specified time-points.||h*ng/L||Standard Error|Least Squares Mean
30567|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours|C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with C-peptide assessment at specified time-points.||h*nmol/L||Standard Error|Least Squares Mean
30568|NCT01596504|Secondary|Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)|Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated.|Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56|PD population. Number of participants analyzed = participants with 7 point SMPG assessment at specified time-points.||mmol/L||Standard Deviation|Mean
30569|NCT01596504|Secondary|Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline.|0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||mmol/L||Standard Error|Least Squares Mean
30570|NCT01596504|Secondary|Change From Baseline to Day 56 in PPG Excursion|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||mmol/L||Standard Error|Least Squares Mean
30571|NCT01596504|Secondary|Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast.|Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||participants|||Number
30584|NCT01596062|Primary|Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84|CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.|Day 84 (Week 12) after transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||Weeks * Percentage of saturated CD25||Standard Deviation|Mean
30585|NCT01595854|Secondary|Number of Participants With Drug Related Adverse Events|The number of participants with drug related adverse events|From screening until the end-of-study examination|Treated set||participants|||Number
30572|NCT01596504|Secondary|Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.||h*mmol/L||Standard Error|Least Squares Mean
30573|NCT01596504|Primary|Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56|Pharmacodynamic (PD) population defined as all randomized participants, who received at least one dose of lixisenatide 20 μg, liraglutide 1.2 mg or liraglutide 1.8 mg, and had both a baseline assessment and at least one post-baseline assessment of any primary or secondary PD variables, irrespective of compliance with study protocol and procedures.||h*mmol/L||Standard Error|Least Squares Mean
30574|NCT01596231|Primary|Drinking Behaviors|A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).|Study end|||beers consumed||Standard Deviation|Mean
30575|NCT01596088|Primary|Adverse Events|Number of participants experienced adverse events|4 weeks|||participants|||Number
30576|NCT01596062|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24|(MDRDa formula) with imputation by last observation carried forward (LOCF)|Day 8, Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||mL/min/1.73m^2||Standard Deviation|Mean
30577|NCT01596062|Secondary|Percentage of Participants With of Treatment Failures|Treatment failure was defined either as a BPAR, a graft loss, a death or a loss to follow-up. An extended treatment failure was also defined including treated borderline lesions, BPAR, graft loss, death or loss to follow-up. Treated borderline lesions were considered as acute rejection by investigators and DMC experts.|Day 84 (Week 12), Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||Percentage of participants|||Number
30578|NCT01596062|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity|Antibody mediated acute rejection: C4d deposition, presence of circulating antidonor antibody, morphologic evidence of acute tissue injury such as acute tubular necrosis-like minimal inflammation or capillary and/or glomerular inflammation and/or thromboses or arterial inflammation. Cellular acute rejection: acute T-cell mediated rejection Type IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IIA: Mild to moderate intimal arteritis. Type IIB: Severe intimal arteritis comprising > 25% of the lumenal area. Type III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation).|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||Percentage of participants|||Number
30579|NCT01596062|Secondary|Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)|BPAR is one of the components of treatment failure. One assessment of efficacy was BPAR. Renal graft biopsies were performed and the renal tissue was examined to determine if there was acute rejection of the renal transplant.|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.||Percentage of participants|||Number
30580|NCT01596062|Secondary|Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells|Cell counts of various subpopulations of T, B and NK lymphocytes (CD3, CD4, CD8, CD19 and CD56) (flow cytometry).|Day 0, Day 6, Day 42, Day 84 (Week 12)|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||10^9 cells/L||Standard Deviation|Mean
30581|NCT01596062|Secondary|Percentage of T-cells That Bind Basiliximab to CD25 Receptors|This is the percentage of T cells binding basiliximab at all timepoints.|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||Percentage of T cells||Standard Deviation|Mean
30582|NCT01596062|Secondary|AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84|Mean AUC was calculated only for patients who received two Simulect injections.|Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.||Weeks * Percentage of T cells||Standard Deviation|Mean
40748|NCT01445951|Other Pre-specified|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population||Events/Subject-Month|||Number
30586|NCT01595854|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
30587|NCT01595854|Primary|Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
30588|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
30589|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
30590|NCT01595438|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
30591|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)||NG/ML||Full Range|Geometric Mean
30592|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)||NG/ML||Full Range|Geometric Mean
30593|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)||NG/ML||Full Range|Geometric Mean
30594|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30595|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30596|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30597|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30598|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30599|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30600|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
30601|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30602|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
30603|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
40749|NCT01445951|Other Pre-specified|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population||percentage of participants|||Number
30605|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
30606|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30607|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30608|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30609|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participant|||Number
30610|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participant|||Number
30611|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participant|||Number
30612|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)||Participant|||Number
30613|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)||Participant|||Number
30614|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participant|||Number
30615|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30616|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30617|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participant|||Number
30618|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)||Participants|||Number
30619|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
30620|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
30621|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30622|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
30623|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
30624|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30625|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)||Participants|||Number
30626|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)||Participants|||Number
30627|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30628|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)||Participants|||Number
30629|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)||Participants|||Number
30630|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))||Participants|||Number
30631|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
30632|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
30633|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))||Participants|||Number
30634|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
32906|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving aripiprazole for whom blood samples were available for analysis.||hr||Standard Deviation|Mean
30635|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )||Participants|||Number
30636|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
30637|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30638|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30639|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30640|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)||Participants|||Number
30641|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)||Participants|||Number
30642|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))||Participants|||Number
30643|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)||Participants|||Number
30644|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)||Participants|||Number
30645|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))||Participants|||Number
30646|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30647|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30648|NCT01595438|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30649|NCT01595438|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30650|NCT01595438|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)||Participants|||Number
30651|NCT01595386|Secondary|ACTH Stimulation Test|AdrenoCorticoTropic Hormone stimulation test will be performed at least 24 hours pre-bypass and immediately after successful discontinuation of bypass and compared. These outcomes will be used as a secondary outcome.|24 hours prebypass and 0 hours post-bypass|||microg/dL||Inter-Quartile Range|Median
30652|NCT01595386|Secondary|Mortality|Subject mortality will in the CICU will be used as a secondary outcome.|Duration of CICU stay, approximately 1 week|||percentage of patients|||Number
30653|NCT01595386|Secondary|CICU Length of Stay|CICU length of stay will be calculated from the time the subject is admitted to the CICU post-op until they are discharged from the unit. This will be used as a secondary outcome.|approximately 1 week|||hours||Inter-Quartile Range|Median
30654|NCT01595386|Secondary|Time Until First Extubation|Respiratory values such as duration of intubation will be used as a secondary outcome.|Until discharge from hospital, approximately 2 weeks|||hours||Inter-Quartile Range|Median
30655|NCT01595386|Secondary|Changes in Baseline Arterial-venous Oxygen Saturation Difference|Respiratory values such as changes in baseline arterial-venous oxygen saturation difference at admission to the pediatric cardiac intensive care unit will be used as a secondary outcome.|admit to the CICU|||percentage of arterial-venous saturation||Inter-Quartile Range|Median
30656|NCT01595386|Secondary|Fluid Balance|Hemodynamic variable such as total fluid balance within the first 48 hours post-op will be used as a secondary outcome. Fluid balance is a calculation of the overall fluid status for a given time period. The total input (fluid, medications, etc) that are given to a patient during a given time frame (24 hours) minus the total output (urine, stool, drainage, etc. ) that comes out of a patient during a given time frame.|1st 48 hours post-op|||mL/kg||Inter-Quartile Range|Median
30657|NCT01595386|Secondary|Average Inotrope Score|Average inotrope score over first 48 hours after Cardiac Intensive Care Unit admission was used as a secondary outcome. Inotrope Score is calculated based on the dose of inotropes currently infusing at a given time points. The formula for calculation is as follows: Epinephrine/Norepinephrine (mcg/kg/min) dose x100, plus Dopamine/Dobutamine (mcg/kg/min) dose x 1, plus Neosynephrine (mcg/kg/min) dose x10, plus Vasopressin (units/kg/hr) [(dose x60)/10,000] = Inotrope Score. Our institution does not include Milrinone in our inotrope score calculation because every patient receives a continuous infusion in the immediate post-operative period. The higher the inotrope score the more cardiac support the patient is requiring or the worse their cardiac function is becoming.|first 48 hours post-op|||Inotrope Score||Inter-Quartile Range|Median
30658|NCT01595386|Secondary|Changes in Baseline Inflammatory Mediators|Changes in pre-op inflammatory mediators will be assessed at 0, 4, 12, 24 and 48 hours post bypass and used as a secondary outcome.|0, 4,12, 24, and 48 hours post bypass|||pg/mL||Inter-Quartile Range|Median
30659|NCT01595386|Secondary|Hospital Length of Stay|The average length of hospital stay from the time the subject is admitted to the CICU post-op until they are discharged will be used as a secondary outcome.|Admit to CICU till hospital discharge, approximately 3 weeks|||days||Inter-Quartile Range|Median
30660|NCT01595386|Secondary|Mean Number of Days Subjects Alive and Ventilator Free|Respiratory variables include such as alive, ventilator free days at 28 days post-op will be used as secondary outcome. The mean number of days subjects were live and ventilator free up to the 28 days after surgery.|up to 28 days post op|||days||Inter-Quartile Range|Median
30661|NCT01595386|Primary|Incidence of Low Cardiac Output Syndrome (LCOS)|Low Cardiac Output Syndrome (LCOS) within the first 48 hours after post-operative admission to the Pediatric Cardiac Intensive Care Unit was used as the primary outcome. This was defined as a double in inotropic support from post-operative admit, requiring Extracorporeal Membrane Oxygenation (ECMO) support, receiving Cardiopulmonary Resuscitation, or death.|first 48 hours after cardiac intensive care unit (CICU) admission post-op|||percentage of patients|||Number
30662|NCT01595282|Secondary|Pain Scores 15 Minutes Post-procedure|21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)|Fifteen minutes after the procedure|||units on a scale||Standard Deviation|Mean
30663|NCT01595282|Secondary|Pain Scores Immediately After Cervical Dilation|21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)|Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula|||units on a scale||Standard Deviation|Mean
30664|NCT01595282|Primary|Immediate Post-procedure Pain Score|The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).|Immediately (within 1 minute) after suction and speculum removal|||units on a scale||Standard Deviation|Mean
30665|NCT01594970|Other Pre-specified|Change From Baseline in Hyperemia Severity in the Study Eye|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.|Baseline, Week 12|Intent to Treat: all treated subjects with data at this time point||Participants|||Number
30666|NCT01594970|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects with data at this time point||Percent Change||Standard Deviation|Mean
30668|NCT01594970|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.|Week 12|Intent to Treat: all treated subjects with data at this time point||Participants|||Number
30669|NCT01594749|Secondary|Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC|No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of participants|||Number
30670|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 24 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of Participants|||Number
30671|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of Participants|||Number
30672|NCT01594749|Primary|Percentage of Participants With Severe Infusion-site Reactions|The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.||Percentage of Participants|||Number
30673|NCT01594749|Primary|Percentage of Participants With Infusion-site Thrombophlebitis|The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.||Percentage of Participants|||Number
30674|NCT01594749|Primary|Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)|A Complete Response was defined as no vomiting and no use of rescue medication.|25 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.||Percentage of Participants|||Number
30675|NCT01594515|Secondary|AUC0-infinity of BI 1015550|Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
30676|NCT01594515|Secondary|Cmax of BI 1015550|Maximum measured concentration of the analyte in plasma.|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
30677|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations|Percentage of subjects with clinically relevant abnormalities in physical examinations.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
30678|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability|Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
30679|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs|Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
30680|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs|Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
30681|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests|Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).|Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
30682|NCT01594515|Primary|Number (%) of Subjects With Drug Related Adverse Events|Percentage of subjects with drug related adverse events.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.||Percentage of Participants|||Number
30683|NCT01594424|Primary|Number of Participants With Serious Infectious Complications Following Transplantation|patients will be in the study for up to 2 years|24 months|||participants|||Number
30684|NCT01594411|Primary|Change in Clinicians' Treatment Decision After Gene Expression Testing|The primary objective was to assess whether the Gene Expression Score (GES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The GES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a GES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The GES has a negative predictive value of 96% for GES <=15 in a popluation referred to myocardial perfusion imaging.|pre- and post- gene expression testing results (on avaerage 2-3 days to receive GES)|The study sites included 9 clinicians at 4 community-based primary care practices who assessed all participants with a valid GES.||number of subjects|||Number
30685|NCT01594294|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.|Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||seconds|Participants|Standard Deviation|Mean
30686|NCT01594294|Primary|Mean Upper Eyelid Margin Staining|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||square millimeters|Participants|Standard Deviation|Mean
30687|NCT01594294|Primary|Mean Upper Eyelid Redness|The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||percentage of total surface measured|Participants|Standard Deviation|Mean
30688|NCT01594294|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||units on a scale|Participants|Full Range|Median
30689|NCT01594294|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.||Units on a scale|Participants|Full Range|Median
30690|NCT01594125|Secondary|Number of Participants With Response by Alpha Fetoprotein (AFP)|Response by AFP is defined as 20% or more decline in AFP between the baseline value and the AFP value after three courses (12 weeks) of therapy. If patients only receive two courses of therapy the AFP value after two courses (8 weeks) will be used for the analysis.|up to 28 months|Patients from TS and AFP evaluation (>20μg/L) at baseline and post-baseline AFP assessment after two or three courses.||participants|||Number
30691|NCT01594125|Secondary|Time to Progression (TTP)|TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0.|up to 28 months|Patients from TS||months||Inter-Quartile Range|Median
30692|NCT01594125|Secondary|Progression Free Survival (PFS)|PFS is defined as the duration from start date of the study treatment to PD according to RECIST 1.0, or any death whichever occurs earlier.|up to 28 months|Patients from TS||months||Inter-Quartile Range|Median
30719|NCT01593592|Primary|Eradication of H Pylori Infection 4 Weeks After Completion of Therapy|H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.|4 weeks therapy|It is assessment of all the 70 participants about H pylori eradication status||participants|||Number
30693|NCT01594125|Secondary|Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Objective response (Complete response (CR) + Partial response (PR), regardless of confirmation) is derived from a patient’s best objective response by RECIST. Best objective response is calculated based on the “overall” visit response from each assessment. Best objective response represents the best response a patient has had during their time in the study up until progression, last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. For patients whose progression event is death, best objective response will be calculated based on data up until the last evaluable RECIST assessment prior to death.|up to 28 months|Treated Set (TS): The treated set includes all patients who were administered at least one dose of any study medication.||participants|||Number
30694|NCT01594125|Primary|Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib|The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase [ALP] elevation >5x ULN, or total bilirubin >3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP > baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid.|up to 28 days|Patients from the MTD set: The MTD set contains only treated patients from the dose escalation that were not replaced for MTD determination.||participants|||Number
30695|NCT01593852|Primary|Cumulative Air Kerma (AK) Value|Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.|Day 0|||mGy||Inter-Quartile Range|Median
30696|NCT01593852|Secondary|Serious Adverse Events||Day 0 if any|||participants|||Number
30697|NCT01593852|Secondary|Usage of Physician Controlled Dose Settings|In both groups, default fluoroscopy dose settings were 'low', but could be changed by the operator to a medium or high setting for better imaging. The necessity to increase fluoroscopy dose for better imaging to medium or high was registered as a percentage of total number of fluoroscopy frames.|Day 0|||percentage of total # of fluoro frames||Standard Deviation|Mean
30698|NCT01593852|Secondary|Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure|If fluoroscopy time (see results in other secondary outcomes), number of exposure frames (see below) and procedure duration (see results in other secondary outcomes) are equivalent between the two groups, this will indicate that image quality (IQ) is equally adequate in both groups.|Day 0|||Number of exposure frames||Standard Deviation|Mean
30699|NCT01593852|Secondary|Fluoroscopy Time||Day 0|||minutes||Standard Deviation|Mean
30700|NCT01593852|Secondary|Procedure Duration||Day 0|||minutes||Standard Deviation|Mean
30701|NCT01593852|Secondary|Physician Professional Judgment on Procedural Success|Measurement of professional judgment (yes/no) of the treating physician.|Day 0|||percentage of procedural success|||Number
30702|NCT01593852|Secondary|Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)|Staff dose measured by Electronic Personal Dosimeter (EPD) worn by the operator over the lead apron (EPD operator) and the other mounted at a fixed location in the EP laboratory (EPD fixed)|Day 0|||µSv||Inter-Quartile Range|Median
30703|NCT01593852|Primary|Cumulative Dose Area Product (DAP) Value|Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.|Day 0|||Gy*cm^2||Inter-Quartile Range|Median
30704|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8|Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.|8 weeks|FAS||Percentage of participants|||Number
30705|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8|Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline|8 weeks|FAS||Percentage of participants|||Number
30706|NCT01593787|Secondary|Percentage of Participants Achieving DBP Control at Week 8|DBP control was defined as msDBP <80 mmHg.|8 weeks|FAS||Percentage of participants|||Number
30707|NCT01593787|Secondary|Percentage of Participants Achieving SBP Control at Week 8|SBP control was defined as msSBP <130 mmHg.|8 weeks|FAS||Percentage of participants|||Number
30708|NCT01593787|Secondary|Percentage of Participants Achieving a Successful BP Control at Week 8|A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg|8 weeks|FAS||Percentage of Participants|||Number
30709|NCT01593787|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8||baseline, 8 weeks|FAS||mmHg||Standard Deviation|Mean
30710|NCT01593787|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements.|baseline, 8 weeks|Full Analysis Set (FAS): This set included all participants who entered the treatment epoch. Patients who were not qualified to enter the treatment epoch were excluded from the FAS provided those participants did not receive LCZ696.||mmHg||Standard Deviation|Mean
30711|NCT01593787|Primary|Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)|Percentage of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set: This set included all participants who received at least one dose of LCZ696. AE analysis was determined by actual treatment, i.e. the LCZ696 dose on the day in which the corresponding summary was targeting. Other safety analysis was determined by the maximum treatment.||Percentage of participants|||Number
30712|NCT01593722|Other Pre-specified|Treatment Efficacy|Proportion of subjects without signs of infection|6 months|Microfilarial count and symptoms||participants|||Number
30713|NCT01593722|Secondary|Proportion of Subjects Who Clear Microfilaremia||14 days|||participants|||Number
30714|NCT01593722|Secondary|Eosinophil Activation|Levels of surface marker expression on eosinophils|3 days|||% cells expressing CD69||Full Range|Geometric Mean
30715|NCT01593722|Secondary|The Frequency of Adverse Events|Symptoms, signs and laboratory abnormalities occurring in the 7 days post-treatment|7 days|||events|||Number
30720|NCT01593215|Secondary|Glucose|Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose||||||
30721|NCT01593215|Primary|Insulin Secretion|insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose|||% increase of Ins30||95% Confidence Interval|Mean
30722|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||grams||Standard Deviation|Mean
30723|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8|"Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated.~sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached."|Baseline to 8 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||grams||Standard Deviation|Mean
30724|NCT01592864|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||Score on a scale||Standard Deviation|Mean
30725|NCT01592864|Primary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|Intent to Treat (ITT) Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.||Score on a scale||Standard Deviation|Mean
30726|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Force (grams)||Standard Deviation|Mean
30727|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 3|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Force (grams)||Standard Deviation|Mean
30738|NCT01592760|Secondary|Incidence of Gastric Aspiration|Gastric aspiration is present when gross gastric contents or bile is observed on or within the device or within the subject's oropharynx. The outcome is the proportion of study subjects in whom the outcome measure was observed.|Measured between successful device placement and device removal for any reason.|||participants|||Number
30739|NCT01592760|Secondary|Incidence of Gastric Insufflation|Gastric insufflation is present when audible air sounds are heard by stethoscope over the subject's epigastrium.|Measured within 5 minutes of device placement/study initiation|||participants|||Number
30728|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 14|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity"|Baseline to Day 14|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Force (grams)||Standard Deviation|Mean
30729|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
30730|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
30731|NCT01592851|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 14|Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.||Score on a scale||Standard Deviation|Mean
30732|NCT01592786|Primary|Number of Confirmed Social Responsiveness Scale (SRS) Responders|"A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks.~The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment."|Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)|Of the 906 patients who enrolled in the study 903 received at least 1 dose of open-label treatment to comprise the Safety Population. The Intent to Treat (ITT) population included the 868 patients in the Safety population who also had at least 1 post–Visit 1 assessment of the SRS total raw score.||participants|||Number
30733|NCT01592773|Primary|Patients With Any Treatment-emergent Adverse Event|Number of patients who experienced 1 or more Treatment Emergent Adverse Event|Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit|Analysis was performed on the 747 patients who took at least 1 dose of investigational product (Safety Population).||participants|||Number
30734|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured at 24 hours after device placement/study initiation|||participants|||Number
30735|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at Discharge|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured prior to discharge from phase II of the post-anesthesia care unit/recovery room|||participants|||Number
30736|NCT01592760|Secondary|Overall Clinical Usefulness|Excellent, good, fair, or inadequate. Scale defined by clinical measures and observations.|Reported by the device operator at the time of device removal|||participants|||Number
30737|NCT01592760|Secondary|Incidence of Oropharyngeal Injury|Oropharyngeal injury is defined as a new lip, tongue, buccal, or pharyngeal abrasion or laceration or dental damage observed in the immediate recovery area after use of a study device.|Measured in the post-anesthesia care unit/recovery room within 15 minutes after device removal|||participants|||Number
30741|NCT01592760|Secondary|Device Position in Relation to the Vocal Cords|Device position in relation to the vocal cords is assessed with a flexible fiberoptic camera and graded as follows: 1 = full view of the vocal cords, 2 = partial view of the vocal cords including the arytenoids, 3 = view of the epiglottis only, and 4 = other (device cuff, pharynx or other structures).|Measured within 5 minutes of successful study device placement|||participants|||Number
30742|NCT01592760|Secondary|Device Ease of Insertion|Device ease of insertion is graded as either easy, slightly difficult, difficult, or impossible. The outcome measure is the proportion of successful study device placements recorded as easy versus slightly difficult versus difficult versus impossible.|Reported by the device operator at the time successful device placement is recorded.|||participants|||Number
30743|NCT01592760|Secondary|Device Placement Success Rate|Device placement success rate is defined as the proportion of devices successfully placed within three attempts at device placement.|Measured at the time of attempted study device placement immediately after the induction of general anesthesia|||participants|||Number
30744|NCT01592760|Secondary|Device Placement Time|Device placement time is the time measured in seconds from when the study investigator picks up the airway device to confirmation of ventilation by the presence of an adequate end-tidal carbon dioxide tracing on the monitor.|Measured at device placement/study initiation|||seconds||Standard Deviation|Mean
30745|NCT01592760|Primary|Airway Seal Pressure After Device Placement|Airway seal pressure is defined as the pressure in cmH2O at which the needle of a manometer attached to the anesthesia circuit reaches equilibration, associated with an audible air leak from the subject's oropharynx or gastric insufflation, limited to a maximum pressure of 40 cmH2O. It is measured with the subject's head and neck in neutral position, the expiratory valve on the anesthesia machine closed, and the fresh gas flow set to five liters per minute.|Measured within 5 minutes after device placement/study initiation|||cmH2O||Standard Deviation|Mean
30746|NCT01592708|Secondary|Post-discharge Vomiting||1 week post discharge|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.||percentage of subjects with PDV|||Number
30747|NCT01592708|Primary|Post-operative Vomiting||End of surgery to discharge from hospital|||percentage of subjects with POV|||Number
30748|NCT01592708|Secondary|Post-discharge Nausea|To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital|1 week from discharge from hospital|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.||percentage of subjects with PDN|||Number
30749|NCT01592708|Secondary|Hospital Length of Stay|Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.|Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours|||hours||Inter-Quartile Range|Median
30750|NCT01592708|Primary|Post-operative Nausea|End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.|End of surgery to discharge from hospital|||percentage of subjects with PON|||Number
30751|NCT01592396|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit|Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.|Day 1 and Day 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||participants|||Number
30752|NCT01592396|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants.|Day 1 to Day 57|Safety population included all participants who received investigational product.||participants|||Number
30753|NCT01592396|Primary|Terminal Phase Elimination Half Life (t1/2)|Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||days||Standard Deviation|Mean
30754|NCT01592396|Primary|Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||mcg*day/mL||Standard Deviation|Mean
30755|NCT01592396|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||(microgram*day)/milliliter (mcg*day/mL)||Standard Deviation|Mean
30756|NCT01592396|Primary|Maximum Observed Serum Concentration (Cmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
30757|NCT01592396|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.||days||Full Range|Median
30758|NCT01592344|Secondary|Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey|Patient satisfaction with the StimRouter System was rated on a numerical rating scale (range 0 to 10), with 0 indicating not satisfied at all and 10 indicating completely satisfied.|at the 3-month follow-up|All subjects who completed the survey at Month 3 were included in this analysis. Four subjects in each study arm (4/45 Treatment; 4/49 Control) failed to complete the satisfaction survey.||units on a scale||Standard Deviation|Mean
30759|NCT01592344|Secondary|Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.|"Worst pain in the last 24 hours assessed using 7-day patient pain diary scores for BPI ranging from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Change from baseline to Month 3 was compared."|at baseline and 3 month follow-up|All available data were analyzed from both treatment arms.||units on a scale||Standard Deviation|Mean
30760|NCT01592344|Secondary|Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).|Patient Global Impression of Change in activity limitations, symptoms, emotions and overall life quality related to their painful condition (Range 1 to 7, with 1 indicating no change and 7 indicating a great deal better/considerable improvement).|at 3 month follow-up|All patients who completed the 3 month Global Impression of Change questionnaire were included. Four patients in each study arm failed to complete the questionnaire.||units on a scale||Standard Deviation|Mean
30761|NCT01592344|Primary|Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%|The average pain at rest was assessed using a numerical (0-10) rating scale (NRS) on the Brief Pain Inventory (BPI) Short Form (SF). A higher score indicates worse pain (10=worst pain imaginable) and zero indicates 'no pain at all'. A pain reduction of greater than or equal to 30% on the NRS was considered to be clinically relevant.|Baseline and at 3-month follow-up.|Intent to treat (ITT) population was analyzed.||participants|||Number
30762|NCT01592292|Secondary|Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Baseline up to Month 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria.||participants|||Number
30763|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
30764|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
30765|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||mg/dL||Standard Deviation|Mean
30766|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
30767|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||mm/hr||Standard Deviation|Mean
30821|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes|||hours||Full Range|Geometric Mean
30768|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||millimeter/hour (mm/hr)||Standard Deviation|Mean
30769|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||number of swollen joints||Standard Deviation|Mean
30770|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||number of swollen joints||Standard Deviation|Mean
30771|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.||number of tender joints||Standard Deviation|Mean
30772|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.||number of tender joints||Standard Deviation|Mean
30773|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in DAS28 at Month 12|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 12|Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point.||units on a scale||Standard Deviation|Mean
30774|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set.||units on a scale||Standard Deviation|Mean
30775|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria.||units on a scale||Standard Deviation|Mean
30776|NCT01592071|Primary|Waist-Hip Ratio (WHR)|Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).|30, 60 or 90 days from baseline|||ratio||Standard Deviation|Mean
30777|NCT01592071|Primary|Hip Circumference|Measure of body composition: hip circumference (cm).|30, 60 or 90 days from baseline|||centimeters||Standard Deviation|Mean
30778|NCT01592071|Secondary|Quality of Life|Quality of life categories measured with the SF-36 Health Survey. The SF-36 Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index.The SF-36 provides a t-score for each scale or domain ranging from 0-100 with higher scores representing better perceived quality of life.|30, 60 or 90 days from baseline|||Scores on a scale||Standard Deviation|Mean
30779|NCT01592071|Secondary|Heart Rate|Heart rate measured.|30, 60 and 90 days from baseline|||bpm||Standard Deviation|Mean
30780|NCT01592071|Primary|Waist Circumference|Measure of body composition: waist circumference (cm).|30, 60 and 90 days from baseline|||centimeters||Standard Deviation|Mean
30784|NCT01592045|Primary|Peak Plasma Concentration (Cmax)|"Twenty-two PK samples will be obtained at the following timepoints:~Courses 1 and 3:~Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample~Courses 2 and 4:~Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment|||ng/mL||Standard Deviation|Mean
30785|NCT01592045|Primary|Area Under the Plasma Concentration Curve (AUC)|"Twenty-two PK samples will be obtained at the following timepoints:~Courses 1 and 3:~Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample~Courses 2 and 4:~Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment|||mcg*hr/mL||Standard Deviation|Mean
30786|NCT01592006|Secondary|Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients|Tolerability and Safety will be measured and reported by serious adverse events.|6 years from the start of the study|||participants|||Number
30787|NCT01592006|Primary|The Efficacy of Triple Antiviral Therapy|To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy [SVR24])|3 years from start of study|||percentage of participants|||Number
30788|NCT01591954|Secondary|Data Recording for Retrospective Analysis|"The secondary outcome variable of this study is the data recorded by the video augmentation system during pertinent portions of the operation. We will be targeting steps in the procedure that would have the greatest benefit from an augmented video scene to be used later for further studies. Such data will form the subject of retrospective analysis of workflow.~Three sets of data will be collected to be able to reconstruct the video scene for analysis of the system:~- Tracked Endoscope information.~- Video from endoscopy~- Planning CT/MRI data"|Data is recorded during case.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.|||||
30789|NCT01591954|Primary|Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist|"The qualitative assessment of new video augmentation software by the three surgeons surveys the effect of video augmentation overlay on overall surgical confidence, procedure, approach, and visualization.~= Significant hindrance / Negative effect;~= Minor hindrance / Slightly negative effect;~= Not helpful / No benefit or hindrance;~= Somewhat helpful / Slight benefit;~= Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time, personnel and possible contamination."|Assessment is immediate, following operation.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.|||||
30790|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.|End of therapy fecal levels of OP-1118 (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data||microgram/g||Standard Deviation|Mean
30791|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.|3-5 hour plasma levels of OP-1118 (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data||ng/mL||Standard Deviation|Mean
30792|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.|Positive clinical response without recurrence through the follow-up period|28 days post-treatment|Treated subjects with positive toxin assay result within 24 hours of enrollment||percentage of participants||95% Confidence Interval|Number
30793|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Clinical Response.|Positive clinical response defined as resolution of diarrhea|Day 10|Treated subjects with positive toxin assay result within 24 hours of enrollment||percentage of subjects||95% Confidence Interval|Number
30794|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Fecal Samples.|End of therapy fecal levels of fidaxomicin (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data||microgram/g||Standard Deviation|Mean
30795|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Plasma Samples.|3-5 hour plasma levels of fidaxomicin (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data||ng/mL||Standard Deviation|Mean
30796|NCT01591863|Primary|Number of Participants With Adverse Events.|Number of participants with adverse events, as categorized by MedDRA.|Enrollment through end of study (Day 38-41)|Subjects receiving any amount of study drug||participants|||Number
30797|NCT01591837|Secondary|Frequency of Any Unsolicited AEs.|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
30798|NCT01591837|Secondary|Frequency and Intensity of Any Solicited Adverse Events (AEs).|"The percentage of participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only.~Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site.~Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise.~Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented normal, everyday activities."|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.||percentage of participants|||Number
40775|NCT01445873|Secondary|Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications|Use of PAH-related medications other than Thelin described by class of agent received.|Day 1 to Month 6|FAS||percentage of participants|||Number
30799|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
30800|NCT01591837|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) was defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||geometric mean fold increase||95% Confidence Interval|Geometric Mean
30801|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) was defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) was defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.||percentage of participants||95% Confidence Interval|Number
30802|NCT01591681|Secondary|Percent of Nights With Sensor Glucose >250 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
30803|NCT01591681|Secondary|Overnight Area Under the Curve 250 mg/dl Per 8 Hour|The measure is reporting area under the curve for glucose concentrations below 250 mg/dL and above 60 mg/dL. Overall time below and above a threshold and area under a curve was divided by total time and multiplied by 8 hours.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||mg*hr/dL|Participants|Inter-Quartile Range|Median
30804|NCT01591681|Secondary|Overall Mean Sensor Glucose Overnight|Calculated as the median of the overall mean.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||mg/dl|Participants|Inter-Quartile Range|Median
30805|NCT01591681|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|42 mornings following night of system use|||percentage of mornings|Participants||Number
30806|NCT01591681|Secondary|Percent of Mornings With Blood Ketones >1.0 mmol/L|Blood ketones measured with a study blood ketone meter.|42 mornings following night of system use|||percentage of mornings|Participants||Number
30807|NCT01591681|Secondary|Percent of Mornings With Glucose >250 mg/dL|Measured with a study home blood glucose meter.|42 mornings following night of system use|||percentage of mornings|Participants||Number
30808|NCT01591681|Secondary|Median Morning Blood Glucose|Measured with a study home blood glucose meter.|42 mornings following night of system use|||mg/dl|Participants|Inter-Quartile Range|Median
30809|NCT01591681|Secondary|Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
30810|NCT01591681|Secondary|Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
30811|NCT01591681|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL|The median percentages of the number of glucose values with values of 71-180 mg/dL overall.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage glucose values|Participants|Inter-Quartile Range|Median
30812|NCT01591681|Primary|Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl|Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|||percentage of nights|Participants||Number
30813|NCT01591616|Secondary|ECGs (QTcB Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
30814|NCT01591616|Secondary|ECGs (QT Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
30815|NCT01591616|Secondary|ECGs (QRS Duration)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
30816|NCT01591616|Secondary|ECGs (PR Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||milliseconds||Standard Deviation|Mean
30817|NCT01591616|Secondary|ECGs (Ventricular Heart Rate)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.|||Beats per minute||Standard Deviation|Mean
30818|NCT01591616|Secondary|Vital Signs (Diastolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose|||mmHg||Standard Deviation|Mean
30819|NCT01591616|Secondary|Vital Signs (Systolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.|||mmHg||Standard Deviation|Mean
30822|NCT01591616|Secondary|Safety|"The % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.~ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals.~Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose.~For each subject, phone call was made at +24h as follow up pursuant to the protocol."|blood draws pre-dose, 2 and 4 hours postdose|||Percentage MetHb||Standard Deviation|Mean
30823|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
30824|NCT01591499|Secondary|Lens Preference - Ophthalmologist|"Ophthalmologists preference in terms of lenses rated by questionnaire with a limited selected response. (“Choice of Lens? First pair of lenses, Second pair of lenses”) (Biofinity, Air Optix, or Purevision)~Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 8 missing values; Evaluated at least one lens N=138, 16 missing values.)||percentage of investigators|Participants||Number
30825|NCT01591499|Secondary|Lens Preference - Participant|"The number of participants who preferred a lens pair rated by diary questionnaire with a limited selected response.(“Which pair of lenses did you prefer? The first pair, the second pair). Reported per lens.~Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 7 missing values; Evaluated at least one lens N=138, 15 missing values.)||percentage of participants|||Number
30826|NCT01591499|Secondary|Clinical Performance - Lens Wettability|"The ophthalmologist’s rating of lens wettability by questionnaire as a limited selected response (Zero, Low, Acceptable, Good or Excellent). Assessed with the slit lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||percentage of investigators|||Number
30827|NCT01591499|Secondary|Geometric Performance - Lens Mobility|"The ophthalmologist’s rating of lens movement during blinking by questionnaire as a limited selected response (Optimal, Acceptable with a tendency to be tight, Acceptable with a tendency to be Flat, Unacceptable and too tight, or Unacceptable too flat). Assessed with the slit-lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||Investigators|||Number
30828|NCT01591499|Secondary|Geometric Performance - Lens Centration|"Description: The ophthalmologist’s rating of lens centration during “Focus” and “Shift When Blinking” by questionnaire as a limited selected response (Optimal, Decentration Acceptable or Decentration Unacceptable). Assessed with the slit lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 12 missing values; Air Optix Aqua Multifocal N=70, 9 missing values; Purevision Multifocal N=68, 6 missing values)||Investigators|||Number
30829|NCT01591499|Secondary|Comfort of Use - Average Wearing Time|"The average numbers of hours per day of lens wear by patient. Reported per lens. Calculated by number of hours worn.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two Patients’ subjective rating for lens comfort of use by patient diary and reported per lens. (Average Wearing Time in hours per day)"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 11 missing values; Air Optix Aqua Multifocal N=70, 10 missing values; Purevision Multifocal N=68, 4 missing values)||hours/day||Standard Deviation|Mean
30830|NCT01591499|Secondary|Subjective Rating of Lens Comfort - General Comfort|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (General Comfort, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)||units on a scale||Standard Deviation|Mean
30831|NCT01591499|Secondary|Subjective Rating of Lens Comfort - End of Day|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (At End of Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||units on a scale||Standard Deviation|Mean
30832|NCT01591499|Secondary|Subjective Rating of Lens Comfort - During Day|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (During the Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)||units on a scale||Standard Deviation|Mean
30866|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 11 predose to 24 hours post dose|All randomized participants||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
30833|NCT01591499|Secondary|Subjective Rating of Lens Comfort, Fitting|"Patients' subjective rating for lens comfort by patient diary and reported per lens. (After lens fitting, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)||units on a scale||Standard Deviation|Mean
30834|NCT01591499|Secondary|Visual Performance - Near Stereoscopic Vision|"The mean number of occurrences where the “number of the last figure where the patient equipped with analyzers can make out the raised circle (from number 1 to 9),” performed at a distance of 40 centimeters, using Wirt Vectographic Stereopsis Test. Reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 10 missing values; Air Optix Aqua Multifocal N=70, 7 missing values; Purevision Multifocal N=68, 4 missing values)||number of occurrances||Standard Deviation|Mean
30835|NCT01591499|Secondary|Visual Performance: Distance, High Contrast Vision|"The number of letters read at a distance of 5 meters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
30836|NCT01591499|Secondary|Visual Performance: Distance, Low Contrast Vision|"The number of letters read at a distance of 5 meters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
30837|NCT01591499|Secondary|Visual Performance: Near, High Contrast Vision|"The number of letters read at a near of 40 centimeters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
30838|NCT01591499|Secondary|Visual Performance - Near, Low Contrast Vision|"The number of letters read at a near of 40 centimeters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)||number of letters read||Standard Deviation|Mean
30839|NCT01591499|Secondary|Visual Performance - Quality of Distance Vision|"Patients' subjective rating for quality of distance vision by patient diary and reported per lens. (driving, looking at a landscape, etc. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)||units on a scale||Standard Deviation|Mean
30840|NCT01591499|Secondary|Visual Performance - Quality of Intermediate Vision|"Patients' subjective rating for quality of intermediate vision by patient diary and reported per lens. (distance equivalent to an arm's length. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 3 missing values)||units on a scale||Standard Deviation|Mean
30841|NCT01591499|Secondary|Visual Performance - Quality of Near Vision|"Patients' subjective rating for quality of near vision by patient diary and reported per lens. (40cm away: reading a newspaper, looking at your watch etc. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)||units on a scale||Standard Deviation|Mean
30842|NCT01591499|Secondary|Visual Performance - Distance Visual Acuity|"Description: The participant’s distance binocular visual acuity (at 5 meters) using the La Galinet method. (Decimal scale, Excellent=between 5 and 20 tenths at 5 metres and between 1 and 20 tenths at 40 cm)~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measure at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 6 missing values; Purevision Multifocal N=68, 6 missing values)||decimal units on a scale||Standard Deviation|Mean
30853|NCT01591460|Secondary|Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA|Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100.|At 12 and 24 weeks|All-Treated Population. Arms were not mutually exclusive.||percentage of participants|||Number
30843|NCT01591499|Primary|Visual Performance - Comparison of Initial Refraction to Multifocal Lenses|"The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5).~Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation):~V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Change over time measured at V1, V3 and V5|"Percentage of patients who obtained distance and near binocular visual acuities at least as good as their initial refraction visual acuities.~(Participant Flow: Biofinity Multifocal N=138, 14 missing values; Air Optix Aqua Multifocal N=70, 12 missing values; Purevision Multifocal N=68, 13 missing values)"||percentage of participants|||Number
30844|NCT01591499|Secondary|Visual Performance - Near Visual Acuity|"Description: The participant’s near binocular visual acuity (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5) and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 8 missing values; Purevision Multifocal N=68, 8 missing values)||participants|||Number
30845|NCT01591460|Secondary|Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up|Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.||percentage of participants|||Number
30846|NCT01591460|Secondary|Percentage of Participants With a Concomitant Disease Prior to or During the Study|The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here.|Up to 76 weeks (from Screening until 24 weeks after EOT)|Safety Population.||percentage of participants|||Number
30847|NCT01591460|Secondary|Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up|Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.||percentage of participants|||Number
30848|NCT01591460|Secondary|Time to Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population.||weeks||95% Confidence Interval|Median
30849|NCT01591460|Secondary|Number of Participants With a Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population.||participants|||Number
30850|NCT01591460|Secondary|Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir|The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; only participants providing evaluable data were included in the analysis. Arms were not mutually exclusive.||percentage of participants|||Number
30851|NCT01591460|Secondary|Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; n = number of participants who received the respective study medication. Arms were not mutually exclusive.||percentage of participants|||Number
30852|NCT01591460|Secondary|Duration of Treatment With PEG-IFN, RBV, and Boceprevir|The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment; n = number of participants who received the respective study medication. Arms were not mutually exclusive.||weeks||Full Range|Median
30883|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of the structural brain volume as assessed by the left caudate volume.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.||mm^3||Standard Deviation|Mean
30854|NCT01591460|Secondary|Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA|Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment decline in HCV RNA were included in the analysis. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
30855|NCT01591460|Secondary|Percentage of Participants With Virological Breakthrough Following On-Treatment Response|Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment virological response were included in the analysis. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
30856|NCT01591460|Secondary|Percentage of Participants With Virological Relapse Following EOT Response|Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (at 12 and 24 weeks after EOT)|All-Treated Population; only participants with a previous EOT virological response were included in the analysis. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
30857|NCT01591460|Secondary|Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA|HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, and 28|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
30858|NCT01591460|Secondary|Percentage of Participants With Virological Response|HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
30859|NCT01591460|Secondary|HCV RNA Levels|HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL.|At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)|All-Treated Population; number (n) = number of participants who provided evaluable data at the respective visit. Arms were not mutually exclusive.||log10 IU/mL||Standard Deviation|Mean
30860|NCT01591460|Secondary|Percentage of Participants With SVR at 24 Weeks After EOT|SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 24 weeks after EOT (up to 72 weeks)|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
30861|NCT01591460|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)|SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 12 weeks after EOT (up to 60 weeks)|All-Treated Population. Arms were not mutually exclusive.||percentage of participants||95% Confidence Interval|Number
30862|NCT01591408|Primary|Improved Symptom Ratings|"Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning not at all and 10 being extremely anxious/irritable."|4 weeks|Subjects were active duty military with PTSD diagnosis currently in residential treatment facility||Rating on scale||Standard Deviation|Mean
30863|NCT01591317|Secondary|Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges|Predose up to 24 hours post dose on Day 12|All randomized participants||Percent inhibition of PRU||Standard Deviation|Mean
30864|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants||hours||Full Range|Median
30865|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
30884|NCT01590888|Secondary|Change From Baseline in Urine Biomarkers|Biomarkers assessed primarily with 8-hydroxy-2'-deoxyguanosine, normalised to creatinine concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population||ng/mL||Standard Deviation|Mean
30867|NCT01591317|Secondary|Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation|ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition|Predose up to 24 hours post dose on Day 12|All randomized participants||PRU||Standard Deviation|Mean
30868|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants||hours||Full Range|Median
30869|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
30870|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 1 predose up to 24 hours post dose|All randomized participants||nanogram times hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
30871|NCT01591044|Primary|Change in FEV1|Change from baseline in pre-BD FEV1 (% predicted) at Week 8.|Baseline and Week 8|All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients.||percentage of change||Standard Deviation|Mean
30872|NCT01591018|Secondary|Number of Participants With Clinical Manifested Brain Infarction|to demonstrate an effect of sonolysis on the reduction of risk of clinically stroke due to the activation of endogenous fibrinolytic system during cardiac surgery|30 days after intervention|All enrolled participants were analyzed||participants|||Number
30873|NCT01591018|Secondary|Cognitive Decline|"To demonstrate an effect of sonolysis on the reduction of cognitive decline after cardiac surgery measured by ACE-R.~Adenbook´s cognitive examination - revised (ACE-R) can aquire value 0 to 100. Higher value represents better cognitive functions."|30 days after intervention|"50 out of 60 participants completed all cognitive tests in cardiac surgery with sonolysis group.~50 out of 60 participants completed all cognitive tests in cardiac surgery without sonolysis group."||units on a scale||Inter-Quartile Range|Median
30874|NCT01591018|Primary|Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI|to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions and brain infarctions > 0.5 cm3 in the monitored MCA territory in sonolysis group detected using MRI examination 24 hours after cardiac surgery in 5% level of statistical significance|24 hours after intervention|||participants|||Number
30875|NCT01591005|Other Pre-specified|Number of Participants With Complications|Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.|24 hours and 30 days after intervention|||participants|||Number
30876|NCT01591005|Secondary|Number of Participants With Clinical Vascular Event or Death|"The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) after carotid endarterectomy and carotid stenting using periprocedural sonolysis.~Substudy: The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) between carotid endarterectomy and carotid stenting groups."|30 days after intervention|||participants|||Number
30877|NCT01591005|Secondary|Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups|"The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.~Substudy: The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention|||participants|||Number
30878|NCT01591005|Secondary|Number of Participants With Clinical Manifested Brain Infarction|"The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system during carotid endarterectomy and carotid stenting using periprocedural sonolysis.~Substudy: The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system between carotid endarterectomy and carotid stenting groups."|24 hours and 30 days after intervention|||participants|||Number
30879|NCT01591005|Secondary|Cognitive Decline|"The changes in cognitive functions after carotid endarterectomy and carotid stenting measured by Mini-Mental State Examination using periprocedural sonolysis.~Substudy: The changes in cognitive functions after intervention measured by Mini-Mental State Examination between carotid endarterectomy and carotid stenting groups.~Range of scores possible for the Mini-Mental State Examination: 0 - 30 points. Higher values in this range are considered to be a better outcome."|24 hours after intervention|only patients with performed Mini Mental State examination||Scores on a scale||Inter-Quartile Range|Median
30880|NCT01591005|Secondary|Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups|"The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.~Substudy: The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention|||participants|||Number
30881|NCT01591005|Primary|Participants With a New Brain Infarction Detected Using Magnetic Resonance|"The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting.~Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups."|24 hours after intervention|||participants|||Number
30882|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - TMT Part B|"Trail Making Test Part B was assessed by the number of seconds to complete the test (from 0 to 240 seconds).~The Trails Making Test Part B actual change from baseline at Week 26 was analysed."|Baseline to 26 weeks|Intent to Treat||seconds||Standard Deviation|Mean
30889|NCT01590888|Secondary|Change From Baseline in Investigator Global Assessments by Efficacy Index|Global function was assessed by the Investigator using the clinical global impression (CGI) scale which included assessing the severity of illness and global improvement and calculating the efficacy index for each participant. The efficacy index aims to relate therapeutic effects to reported side effects as assessed by the Investigator (range from 0 [marked improvement and no side effects] to 4 [unchanged or worse] and side effects outweigh therapeutic effects) and is calculated for each participant by dividing the therapeutic effect score by the side effects score. An improvement is reflected by CGI scale Efficacy Index values >1.|Baseline to 26 weeks|Intent to Treat||ratio||Standard Deviation|Mean
30890|NCT01590888|Secondary|Change From Baseline in Behaviour|Total Behavioural score from the Unified Huntington Disease Rating Scale. The behavioural assessment measures the frequency and severity of symptoms related to affect, thought content and coping styles. The total behaviour score is the sum of all responses, with scale range of 0 to 8. Higher scores on the behaviour assessments indicate more severe disturbance than lower scores.|Baseline to 26 weeks|Intent to Treat population analysed||units on a scale||Standard Deviation|Mean
30891|NCT01590888|Secondary|Change From Baseline in Functional Abilities|"Total Functional Capacity (TFC) assessment was based on an individual's ability to perform common daily tasks. TFC score range was 0 to 13.~Higher scores on the function scales indicate better functioning than lower scores."|Baseline to 26 weeks|Intent to Treat Population analysed||units on a scale||Standard Deviation|Mean
30892|NCT01590888|Secondary|Change From Baseline in Motor Function|Total motor score calculated from the Unified Huntington Disease Rating Scale - Motor Function. The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor impairment scores is the sum of all the individual motor ratings, with higher scores indicating more severe motor impairment than lower scores. A maximum score of 60 is possible (range 0-60).|Baseline to 26 weeks|Intent to Treat population analysed, and defined as all participants who received at least one dose of study and underwent at least one post baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
30893|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - Composite z Scores|Cognition composite z-scores were calculated for each participant. The composite scores were defined as the mean of the individual z-scores for the various cognition assessments. The Main Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test and Stroop Word Reading Test. The Exploratory Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, Stroop Word Reading Test and Speeded Tapping test. The Executive Function Composite z-score was calculated from Category Fluency Test and Trail Making Test Part B. There is no unit of measure for the z score as it is the pure number calculated from the SD from the mean. A higher z score indicates an improvement.|Baseline to 26 weeks|Intent to Treat||z score||Standard Deviation|Mean
30894|NCT01590888|Primary|Safety and Tolerability of PBT2 in Patients With HD|As measured by the total number of participants in each dose group who reported at least one adverse events during the study,|Baseline to 26 weeks|Safety population as defined as all participants who received at least one dose of study drug.||participants|||Number
30895|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
30896|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
30897|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30923|NCT01590797|Secondary|Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.||mg/dL||95% Confidence Interval|Least Squares Mean
30898|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30899|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
30900|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
30901|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30902|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30903|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
30924|NCT01590797|Secondary|Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.||A1C %||95% Confidence Interval|Least Squares Mean
30959|NCT01589978|Secondary|Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30904|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
30905|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30906|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30907|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||beats per minute||Standard Error|Least Squares Mean
30908|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population||beats per minute||Standard Error|Least Squares Mean
30909|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||beats per minute||Standard Error|Least Squares Mean
30925|NCT01590797|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.||A1C %||95% Confidence Interval|Least Squares Mean
30960|NCT01589978|Secondary|Target Vessel Revascularization (TVR) Rate|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30910|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 12 Hours (TWA0-12hrs) HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||beats per minute||Standard Error|Least Squares Mean
30911|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||percentage of central pulse pressure||Standard Error|Least Squares Mean
30912|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population||percentage of central pulse pressure||Standard Error|Least Squares Mean
30913|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||percentage of central pulse pressure||Standard Error|Least Squares Mean
30914|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose; except Period 1: Pre-dose and 2, 4, 12 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||percentage of central pulse pressure||Standard Error|Least Squares Mean
30926|NCT01590771|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 24 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.||Participants|||Number
31017|NCT01588496|Secondary|Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
30915|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)||mm Hg||Standard Error|Least Squares Mean
30916|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population||mm Hg||Standard Error|Least Squares Mean
30917|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30918|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)||mm Hg||Standard Error|Least Squares Mean
30919|NCT01590810|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug||participants|||Number
30920|NCT01590810|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug||participants|||Number
30921|NCT01590797|Primary|Number of Participants Discontinuing Study Medication Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 24|The APaT population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.||Participants|||Number
30922|NCT01590797|Primary|Number of Participants With One or More Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 26|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.||Participants|||Number
30958|NCT01589978|Secondary|Cardiac Death or Myocardial Infarction (MI) Rate|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30927|NCT01590771|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 26 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.||Participants|||Number
30928|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
30929|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
30930|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
30931|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
30932|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
30933|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
30934|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
30935|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
30936|NCT01590771|Primary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
30937|NCT01590563|Secondary|Occurrence of Malposition, Expulsion.|Expulsion and malposition are established risks involved with IUD use. Occurrence of these risks may drastically reduce effectiveness. It is expected that the IUB(tm) form will reduce these risks.|12 months|||Number of cases|||Number
30938|NCT01590563|Primary|Efficacy in Preventing Pregnancy|Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.|12 months|||Number of pregnancies|||Number
30939|NCT01590563|Primary|Rates of Uterine Perforation|Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.|During installation|||Number of cases|||Number
30940|NCT01590550|Secondary|Heparin Use Rate|The heparin use rate will be assessed as the percentage of hemodialysis treatments that required additional use of heparin to maintain circuit patency. This will be assessed from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued|||participants|||Number
30941|NCT01590550|Secondary|Saline Flush Rate|Saline flush rate will be assesed as the percentage of hemodialysis treatments that require one or more saline flushes to maintain circuit patency from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued|||participants|||Number
31018|NCT01588496|Secondary|Part A: Change From Baseline in LDL-C at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set||mg/dL||Standard Error|Mean
30942|NCT01590550|Primary|Dialyzer Clotting Rate|Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.|Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued|18 patients and 119 HD treatments||percentage of total treatments|||Number
30943|NCT01590264|Secondary|Change in Tinnitus Handicap Inventory|Participant will complete the Tinnitus Handicap Inventory (THI)at the end of 2 weeks of treatment. Difference of the THI post treatmement minus baseline THI was calculated. Scale ranges in scores from 0 to 100 with 0 = no bother and 100 being the most bothered.|Baseline, 2 weeks|Pilot study convenience sample||units on a scale||Full Range|Median
30944|NCT01590264|Primary|Adverse Events|Subject will be queried for Adverse Events daily for 2 weeks of treatment. This is foremost a feasibility study, so measure of Adverse Events and relation to treatment is primary outcome.|Daily for 2 weeks.|Pilot study based on convenience sample.||participants|||Number
30945|NCT01590238|Primary|Hair Density Change After Three Treatments|Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.|6 months after initial visit|||percentage of pre-treatment hair density||Standard Deviation|Mean
30946|NCT01590212|Primary|Depression Measured on EPDS|"Depression scores as measured on the EPDS post-birth (approximately 8-12 weeks postnatal)~Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-birth (8-12 weeks postnatal)|||scores on a scale||Full Range|Mean
30947|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on the Adult Wellbeing Scale post-birth (approximately 8-12 weeks postnatal)~The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post-birth (8-12 weeks postnatal)|||scores on a scale||Full Range|Mean
30948|NCT01590212|Primary|Depression Measured on EPDS|"Depression as measured on the EPDS at 9-12 weeks after baseline~Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-intervention (approximately 9 -12 weeks after baseline)|||scores on a scale||Full Range|Mean
30949|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on Adult Wellbeing Scale at 9-12 weeks after baseline.~The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post intervention (approximately 9-12 weeks after baseline)|||Scores on a scale||Full Range|Mean
30950|NCT01589978|Secondary|ARC ST Rate in PLATINUM-like Population.|Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).|Annually through 5 years|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.||percentage of participants|||Number
30951|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients|Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)|12 Months|||percentage of patients|||Number
30952|NCT01589978|Secondary|All Death or Myocardial Infarction Rate|See description of individual events.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30953|NCT01589978|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as death not due to cardiac causes.~Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded."|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30954|NCT01589978|Secondary|All Death Rate|All death includes cardiac death and non-cardiac death.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30955|NCT01589978|Secondary|Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30956|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30957|NCT01589978|Secondary|Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30961|NCT01589978|Secondary|Rate of Cardiac Death Events Related to the PROMUS Element Stent|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30962|NCT01589978|Secondary|Cardiac Death Rate|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30963|NCT01589978|Secondary|Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30964|NCT01589978|Secondary|Myocardial Infarction (MI) Rate|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30965|NCT01589978|Secondary|Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent|Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30966|NCT01589978|Secondary|Major Adverse Cardiac Event Rate (MACE)|Composite of cardiac death, myocardial infarction, and target vessel revascularization|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30967|NCT01589978|Secondary|Rate of Longitudinal Stent Deformation|Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.|Index Procedure|||stents|||Number
30968|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|≤24 hours, 30 days, 180 days, annually through 5 years|||percentage of patients|||Number
30969|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients|ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)|12 months|PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776.||percentage of patients|||Number
30970|NCT01589978|Primary|Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients|Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)|12 months|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.||percentage of patients|||Number
30971|NCT01589822|Secondary|Incidence of Stricture||up to Day 90|||participants|||Number
30972|NCT01589822|Secondary|Incidence of GI Leak||90 days|The primary endpoint was absence of leak (success) within 40 days. Any data missing was considered failures. 3 EVICEL and 2 SoC subjects had missing data. These subjects were considered failures for the primary endpoint. The secondary endpoint was incidence of leak within 90 days post operatively. Missing data was not assumed to be leaks.||participants|||Number
30973|NCT01589822|Secondary|Incidence of Adverse Events||up to Day 90|||number of adverse events|||Number
30974|NCT01589822|Primary|Absence of Gastrointestinal (GI) Leak||40 days|||participants|||Number
30975|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.||scores on a scale||Standard Deviation|Mean
30976|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.||scores on a scale||Standard Deviation|Mean
30977|NCT01589653|Secondary|Number of Hypoglycaemic Episodes During the Trial From Baseline|The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level 3.1 mmol/L [56 mg/dL]) during the trial.|Week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). 154 subjects contributed to the analysis.||episodes|||Number
30978|NCT01589653|Secondary|Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline|Change in FPG (laboratory values) from baseline to the end of the treatment period|Week 0, week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). A total of 150 subjects contributed to the analysis.||mg/dL||Standard Deviation|Mean
30979|NCT01589653|Primary|Change in HbA1c From Baseline|Change in HbA1c (%) from baseline to the end of the treatment period.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.||percentage change in HbA1c||Standard Error|Least Squares Mean
30980|NCT01589510|Primary|IOP at Week 14|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.|Week 14|All patients with data for this outcome measure||Millimeters of Mercury||Standard Deviation|Mean
30981|NCT01589510|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure||Patients|||Number
30982|NCT01589510|Secondary|Percentage of Patients Who Continue Lumigan® 0.01% Treatment|Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.|Week 14|All patients||Percentage of Patients|||Number
30983|NCT01589510|Secondary|Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment|Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.|14 Weeks|All patients||Percentage of Patients|||Number
30984|NCT01589510|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure||Patients|||Number
30985|NCT01589510|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure||Patients|||Number
30986|NCT01589510|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 14|All patients with data for this outcome measure||Eyes|Participants||Number
30987|NCT01589510|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
30988|NCT01589484|Secondary|SWL Complications|Secondary endpoint will be SWL complications (i.e. pain, hematuria, urinary tract infection, Steinstrasse)|12 weeks after SWL|||participants|||Number
30989|NCT01589484|Primary|Stone Clearance|After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.|12 weeks after SWL|Fragmentation||participants|||Number
30990|NCT01589445|Primary|Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||μU/ml||Standard Deviation|Mean
30991|NCT01589445|Primary|Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostatic Model Assessment of Beta cell function(HOMA percent B) Analysis 2: Homeostatic Model Assessment of Insulin Sensitivity (Homa percent S)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||percentage||Standard Deviation|Mean
30992|NCT01589445|Primary|Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||Score on a scale ( SI unit)||Standard Deviation|Mean
30993|NCT01589445|Primary|Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||percentage||Standard Deviation|Mean
30994|NCT01589445|Primary|Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||mmol/l||Standard Deviation|Mean
30995|NCT01589445|Secondary|Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.||mg/dl||Standard Deviation|Mean
30996|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
30997|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
30998|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
30999|NCT01589237|Secondary|Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
31000|NCT01589237|Secondary|Changes From Baseline in Glycerol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
40903|NCT01444092|Secondary|IMPACT 3|IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).|Baseline to 8 weeks|Safety analysis set||Units on a scale||Standard Deviation|Mean
31001|NCT01589237|Secondary|Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
31002|NCT01589237|Secondary|Changes From Baseline in Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
31003|NCT01589237|Secondary|Changes From Baseline in Triglyceride Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.||percentage change||Geometric Coefficient of Variation|Geometric Mean
31004|NCT01589237|Primary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death||52 weeks|Safety set (SAF) - All subjects who received at least one dose of study drug and had at least one post-baseline safety assessment in this extension study.||Participants|||Number
31005|NCT01588548|Primary|Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.|Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1|All patients who were evaluable for Response analysis set for RECIST criteria||Participants|||Number
31006|NCT01588496|Primary|Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part B full analysis set (all enrolled participants who received at least 1 dose of investigational product)||percent change||Standard Error|Least Squares Mean
31007|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
31008|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Part B full anlaysis set||percent change||Standard Error|Least Squares Mean
31009|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
31010|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
31011|NCT01588496|Secondary|Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Weeks 6 and 12|Part B full analysis set||percent change||Standard Error|Least Squares Mean
31012|NCT01588496|Secondary|Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12||Baseline and Week 12|Part A full analysis set||ng/mL||Standard Error|Mean
31013|NCT01588496|Secondary|Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set||percentage of participants|||Number
31014|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
31015|NCT01588496|Secondary|Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
31016|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part A full analysis set||percent change||Standard Error|Mean
31019|NCT01588496|Primary|Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set (all enrolled participants who received at least 1 dose of evolocumab)||percent change||Standard Error|Mean
31020|NCT01588444|Primary|Histologic Percentage of Vital Bone Formation|Histologic percentage of vital bone formation in bone cores|18-20 weeks after grafting|||percentage of vital bone||Inter-Quartile Range|Median
31021|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)|pulmonary vascular resistance (PVR) is the resistance the right ventricle must overcome to pump blood into the pulmonary arteries. The change in PVR values from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||mmHg*min/L||Standard Deviation|Mean
31022|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)|Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular overload. The PVRI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||mmHg*min*m^2/L||Standard Deviation|Mean
31023|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|Both the Thermodilution (n=6) and Fick (n=29) methods were used to determine CO and in some cases both methods were utilized; however, only the Fick method was used for (CI) for the purpose of this analysis and included only 29 subjects.||L/min/m^2||Standard Deviation|Mean
31024|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)|Cardiac Output (CO) is the volume of blood ejected by the heart per minute, as measured by right heart catheterization. The value and change from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||L/min||Standard Deviation|Mean
31025|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)|SaO2 measured by Arterial Blood Draw and Blood Gas Analyzer and SvO2 measured via Pulmonary Artery Catheter, are both Hemodynamics Parameters collected during right heart catheterization. Mixed venous oxygen saturation (SvO2) can help to determine whether the cardiac output and oxygen delivery is high enough to meet a patient's needs|Baseline and Week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||Percent of Oxygen saturation||Standard Deviation|Mean
31026|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm)|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. Right Atrial Pressure (RAP) is the pressure of blood in the right atrium of the heart. Pulmonary Capillary Wedge Pressure (PCWP) is used to calculated pulmonary vascular resistance and can help guide therapeutic efficacy. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo these assessments. As such, the evaluable data at Week 24 was summarized using an N of 30 subjects, which is why the number of participants analyzed is inconsistent with the participant flow module.||mmHg||Standard Deviation|Mean
31027|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.||[h(ng/mL)]||Full Range|Median
31028|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.||[Tmax (h)]||Full Range|Mean
31040|NCT01588353|Primary|"The Percentage of Participants That Were Successfully Treated With a Successful Reduction in Contracture to 5°or Less"|"The Primary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were successfully treated where successfully treated was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|30 days after the last injection|The primary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||% Participants|||Number
31029|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.||(ng/mL)||Full Range|Median
31030|NCT01588405|Secondary|Change in Dyspnea-fatigue Index From Baseline to Week 24|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 24|||units on a scale||Full Range|Median
31031|NCT01588405|Secondary|Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 24|The World Health Organization (WHO) Functional Classification was only conducted at baseline for one subject, because the subject discontinued the study prior to the collection of this assessment at the next visit. One subject had this assessment prior to study discontinuation.||participants|||Number
31032|NCT01588405|Secondary|Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24|The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and week 24|||units on a scale||Full Range|Median
31033|NCT01588405|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||units on a scale||Full Range|Median
31034|NCT01588405|Secondary|Change From Baseline in Six-minute Walk Distance at Week 24|The purpose of the 6MWT is to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.||meters||Full Range|Median
31035|NCT01588405|Primary|Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.|Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.|Up to 24 weeks|||participants|||Number
31036|NCT01588353|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the time to first achieve and maintain clinical success after the last injection where clinical success was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||Days||Inter-Quartile Range|Median
31037|NCT01588353|Secondary|Change From Baseline Range of Motion After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the change from baseline range of motion in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||Degrees||Standard Deviation|Mean
31038|NCT01588353|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the mean percent decrease from baseline degree of contracture in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||% of change from baseline||Standard Deviation|Mean
31039|NCT01588353|Secondary|Clinical Improvement After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were clinically improved where clinically improved was defined as reduction in the contracture of the first treated joint by 50% or more from the baseline. The injection was allowed up to 3 times."|30 days after the last injection|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.||% Participants||95% Confidence Interval|Number
31074|NCT01587079|Secondary|Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
31041|NCT01588158|Secondary|Pain Scale|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At enrollment prior to surgery and at the follow-up 2 weeks after the surgery with suture removal|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||||
31042|NCT01588158|Secondary|Expectation of Pain Relief|An 11-point ordinal scale to assess the expectation of how well the pain medication will work after surgery. The scale range is from 0-10, where 0 is not effective at all and 10 is completely effective.|1 day|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||||
31043|NCT01588158|Secondary|Pain Patients Expect After Surgery|an 11-point ordinal scale to assess the amount of pain the patients expect after surgery. The scale range is from 0-10, where 0 is no pain expected and 10 is the worst pain expected|1 day|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||||
31044|NCT01588158|Secondary|PHQ-9|Patient Health Questionnaire-9 to assess symptoms of depression. The scale range is from 0-27, where 0 is no symptoms of depression and 27 is severe depression.|1 day|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||||
31045|NCT01588158|Secondary|PSEQ|The pain self efficacy questionnaire measures a patient's belief about his/her ability to complete a task despite his/her pain. The scale range is from 0-60, where 60 represents higher self-efficacy beliefs.|1 day|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||||
31046|NCT01588158|Secondary|QuickDASH|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At enrollment prior to surgery and at the follow-up 2 weeks after the surgery with suture removal|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||||
31047|NCT01588158|Primary|Satisfaction With Pain Relief|an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief. The scale range is from 0-10, where 0 is complete dissatisfaction with pain relief and 10 is complete satisfaction.|at the follow-up, 2 weeks after the operation with suture removal|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||||
31048|NCT01587989|Secondary|Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score|TSQM scores were obtained by scoring participants’ responses to a 14-item questionnaire. TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.|Week 24|ITT population||score on a scale||Standard Deviation|Mean
31049|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores|VAS scores were obtained by scoring participants’ disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale. The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
31050|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
31051|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire – Disability Index (HAQ-DI) Score|HAQ-DI scores were obtained by scoring participants’ responses to a 20-item questionnaire. HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do). The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
31052|NCT01587989|Secondary|Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24|The RADAI-5 is a combined index for measuring disease activity in RA. RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months? (0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling? (0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today? (0 = no pain to 10 = unbearable pain); how would you describe your general health today? (0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning? If yes, how long did this stiffness last? (0 = no stiffness to 10 = stiffness the whole day). RADAI was calculated according to the following formula: [question (Q) 1 + Q2 + Q3 + Q4 + Q5]/5. RADAI-5 from 0-1.4 = remission.|Week 24|ITT population||percentage of participants|||Number
31053|NCT01587989|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24|The SDAI is a combined index for measuring disease activity in RA. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal < 1 mg/dL. CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP. SDAI < 3.3 = remission.|Week 24|ITT population||percentage of participants|||Number
31075|NCT01587079|Secondary|Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
40904|NCT01444092|Secondary|PCDAI|Paediatric Crohn’s Disease Activity Index. Range from 0 (best) to 100 (worst).|Baseline to 8 weeks|Full analysis set||Units on a scale||Standard Deviation|Mean
31054|NCT01587989|Secondary|vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24|The CDAI is a combined index for measuring disease activity in RA. CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS. CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA. CDAI < 2.8 = remission.|Week 24|ITT population||percentage of participants|||Number
31055|NCT01587989|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 = 0.56 * √ of TJC + 0.28 * √ of SJC + 0.70 * ln ESR mm/hr + 0.014 * GH in mm VAS. DAS28 < 2.6 = remission.|Week 24|ITT population||percentage of participants|||Number
31056|NCT01587989|Primary|Change From Week 12 (Randomization) to Week 24 in DAS28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population||score on a scale||Standard Deviation|Mean
31057|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.|Baseline, 20 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.||Units on a scale||95% Confidence Interval|Mean
31058|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.|Baseline, 10 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.||Units on a scale||95% Confidence Interval|Mean
31059|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.|Baseline, immediately post administration of treatment|Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed.||Units on a scale||95% Confidence Interval|Mean
31060|NCT01587885|Secondary|Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire|End of Treatment Quality of Life was based on a questionnaire regarding quality-of-life issues associated with heartburn, completed by participants at the end of treatment period 1 and the end of treatment period 2.|End of treatment period 1 and end of treatment period 2|Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.||percentage of partcipants|||Number
31061|NCT01587885|Secondary|Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.||participants|||Number
31062|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.||participants|||Number
31063|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.|At end of study (approx. Study Day 40)|Participants in the Intent-to-Treat (ITT) population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.||participants|||Number
31076|NCT01587079|Secondary|Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning post-dose daily peak flow readings on|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
31077|NCT01587079|Secondary|Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning pre-dose daily peak flow readings|Day 7|MITT||L/min||95% Confidence Interval|Least Squares Mean
31064|NCT01587885|Secondary|Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time|"Onset of heartburn relief was defined as a reduction of at least one grade from baseline in the severity of heartburn following start of treatment. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:~Absent (0): Heartburn is not present.~Mild (1): Heartburn did not last long or was easily tolerated.~Moderate (2): Heartburn caused discomfort and interrupted usual activities.~Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 72 hours|"Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included."||percentage of participants|||Number
31065|NCT01587885|Primary|Time-to-onset of Heartburn Relief|"Time-to-onset of heartburn relief was defined as earliest time following start of treatment that participant experienced a reduction of at least one grade from baseline in the severity of heartburn. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:~Absent (0): Heartburn is not present.~Mild (1): Heartburn did not last long or was easily tolerated.~Moderate (2): Heartburn caused discomfort and interrupted usual activities.~Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 24 hours|"Participants in the modified Intent-to-Treat (mITT) population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included."||Minutes||Inter-Quartile Range|Median
31066|NCT01587651|Secondary|Percentage of Subjects With High On-treatment Platelet Reactivity|"Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment.~A poor response of the platelets to drug, called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events"|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population||percentage of subjects|||Number
31067|NCT01587651|Secondary|PRU Percent Inhibition (Calculated)|"Analysis of Mean Calculated Percent Inhibition by time point~Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU – PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population||Percent Inhibition||Standard Error|Least Squares Mean
31068|NCT01587651|Secondary|PRU Percent Inhibition (Device-reported)|"PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment~VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population||percent inhibition||Standard Error|Least Squares Mean
31069|NCT01587651|Secondary|Platelet Reactivity Index|"Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.~The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary Population||percentage PRI||Standard Error|Least Squares Mean
31070|NCT01587651|Secondary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment|2, 4, 24, 48 hours after first randomized dose|Primary Population||PRU||Standard Error|Least Squares Mean
31071|NCT01587651|Primary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.|7 days after first randomized dose|Primary Population includes all subjects who received at least 1 dose of randomized study drug and have valid PRU data at both randomization visit pre-dosing and end-of-treatment visit. A subject is considered to have valid PRU data for primary PD analyses if he/she does not have certain protocol deviations listed in Statistical Analysis Plan.||PRU (P2Y12 Reaction Units)||Standard Error|Least Squares Mean
31072|NCT01587118|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS)|BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; highest score 126. Overall JE and Gorham DR. The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacol Bulletin 1993; 24:97-99.|Baseline, week 4, 8, 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively||units on a scale||Standard Deviation|Mean
31073|NCT01587118|Primary|Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total|CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.|baseline, week 4, 8, and 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively||units on a scale||Standard Deviation|Mean
31089|NCT01587014|Secondary|Determine Research Subject's Baseline Temperature.|Using intermittent temperature data obtained with Prima-Temp temperature patch and wireless transmission to a receiver box and PC, researchers will compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.|0-14 days|||data unavailable|||Number
31090|NCT01587014|Primary|Assess Safety of the Prima-Temp Temperature Patch With Nursing Staff Skin Site Assessments.|The nursing staff will complete a thermometer skin site assessment daily. If the patch is removed or dislodged prior to study day 7 and 14 data points for any reason other than temporary transfer from the floor for a medical study, the nursing staff will be asked to complete an additional comfort skin site assessment. The area evaluated by the nurse will include skin in contact with both the Covidien/Kendall Lifetrace® belt and the thermometer patch.|0-14 days|||Adverse event|||Number
31091|NCT01587001|Secondary|Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels|We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo.|8 weeks of anti-oxidant therapy|||nmol/mg protein||Standard Deviation|Mean
31092|NCT01587001|Primary|Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels|Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)|8 weeks of anti-oxidant therapy|||pg/ml||Standard Deviation|Mean
31093|NCT01586975|Primary|PFA1|"Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds."|3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)|||seconds||Standard Error|Mean
31094|NCT01586962|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour|||Participants|||Number
31095|NCT01586962|Secondary|Subject Acceptability of the Syrup|"How do you like the warming sensation you have experienced for this product?~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour|||Participants|||Number
31096|NCT01586962|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation|1 minute|||mm||Standard Deviation|Mean
31097|NCT01586897|Primary|Medication Safety Monitoring - ACE/ARB, Thiazide|Percentage of laboratory tests (potassium for thiazides, renal/potassium for ACE/ARBs that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of ACE/ARBs recommend renal/potassium testing and potassium testing for prescription of thiazides. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed ACE/ARB, thiazide||percentage of tests within 4 weeks|||Number
31098|NCT01586897|Primary|Medication Safety Monitoring - Metformin|Percentage of renal function laboratory tests that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of metformin recommend renal function testing. We chose 4- weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed metformin||percentage of tests within 4 weeks|||Number
31099|NCT01586897|Primary|Medication Safety Monitoring - Statins|Percentage of laboratory tests (liver function tests after a new statin prescription or a change in statin dose) that have been measured within 4 weeks following prescription. Treatment guidelines for prescription of statins recommend follow-up liver function testing. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed statins||percentage of tests within 4 weeks|||Number
31100|NCT01586897|Primary|Primary Effectiveness Outcome - A1c|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for HbA1c(HbA1c ≤ 7.0%).|1 year|Patients prescribed oral medications for diabetes control during the study period||percentage of time spent at goal||Standard Deviation|Mean
31101|NCT01586897|Primary|Primary Effectiveness Outcome - LDL|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for LDL(LDL-cholesterol ≤ 130 mg/dL for patients without cardiovascular risk and ≤ 100 mg/dl for patients with cardiovascular risk).|1 year|Patients prescribed statins during the study period||percentage of time spent at goal||Standard Deviation|Mean
31102|NCT01586806|Secondary|Opioid-Related Side Effects (Drowsiness)|Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.|Up to 2 days following surgery|||units on a scale||Inter-Quartile Range|Median
31103|NCT01586806|Secondary|Postoperative Morphine Consumption|Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.|Up to 2 days following surgery|||milligrams||Inter-Quartile Range|Median
31104|NCT01586806|Secondary|Patient Satisfaction|Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);|Up to 2 days following surgery|||units on a scale||Inter-Quartile Range|Median
31105|NCT01586806|Secondary|NRS (Numerical Rating Scale) Pain Scores|Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.|Postoperative day 1|||units on a scale||Inter-Quartile Range|Median
31106|NCT01586806|Primary|Patient-perceived Duration of Analgesia|After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.|Up to 2 days following surgery|||hours||95% Confidence Interval|Median
31107|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||ng/dL||Standard Deviation|Mean
31108|NCT01586364|Primary|Change From Baseline in SHBG Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||nmol/L||Standard Deviation|Mean
31113|NCT01586364|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||IU/L||Standard Deviation|Mean
31114|NCT01586364|Primary|Change From Baseline in Estradiol (E2) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||pg/mL||Standard Deviation|Mean
31115|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.||units||Standard Deviation|Mean
31116|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.||pH||Standard Deviation|Mean
31117|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.||units||Standard Deviation|Mean
31118|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.||pH||Standard Deviation|Mean
31119|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
31120|NCT01586364|Primary|Change From Baseline in ALT, AST and CK Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.||U/L||Standard Deviation|Mean
31121|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
31122|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
31123|NCT01586364|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||U/L||Standard Deviation|Mean
31124|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
31125|NCT01586364|Primary|Change From Baseline in MCV and MPV at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||fL||Standard Deviation|Mean
31126|NCT01586364|Primary|Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
31127|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
31128|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||(x10(12)/L)||Standard Deviation|Mean
31129|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.||(x10(9)/L)||Standard Deviation|Mean
31130|NCT01586364|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||fL||Standard Deviation|Mean
31131|NCT01586364|Primary|Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
31132|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||g/dL||Standard Deviation|Mean
31133|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||(x10(12)/L)||Standard Deviation|Mean
31134|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.||(x10(9)/L)||Standard Deviation|Mean
31135|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
31136|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.||s||Standard Deviation|Mean
40905|NCT01444092|Primary|Adverse Event|Number of patients with at least one adverse event|12 weeks|Safety analysis set||Patients|||Number
31137|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
31138|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.||mg/dL||Standard Deviation|Mean
31139|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.||s||Standard Deviation|Mean
31140|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
31141|NCT01586364|Primary|Assessment of Breast Palpation at Visit 3|Breast palpation was used to assess breast abnormalities.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||Participants|||Number
31142|NCT01586364|Primary|Assessment of Breast Palpation at Visit 2|Breast palpation was used to assess breast abnormalities.|Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||Participants|||Number
31143|NCT01586364|Primary|Assessment of Cervical Pap Smear Samples (if Cervix is Intact)|Cervical Pap smear samples are used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed.||Participants|||Number
31144|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 3|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed.||units on a scale||Standard Deviation|Mean
31145|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 2|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.||units on a scale||Standard Deviation|Mean
31146|NCT01586364|Primary|Change From Baseline in BMI at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||kg/m^2||Standard Deviation|Mean
31147|NCT01586364|Primary|Change From Baseline in Weight at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||kg||Standard Deviation|Mean
31148|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||bpm||Standard Deviation|Mean
31149|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.||mmHg||Standard Deviation|Mean
31150|NCT01586364|Primary|Change From Baseline in Body Mass Index (BMI) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||kg/m^2||Standard Deviation|Mean
31151|NCT01586364|Primary|Change From Baseline in Weight at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||kg||Standard Deviation|Mean
31152|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||bpm||Standard Deviation|Mean
31153|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 2|Systolic blood pressure (SBP), diastolic blood pressure (DBP)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.||mmHg||Standard Deviation|Mean
31154|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
31155|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed.||percent change||Standard Deviation|Mean
31156|NCT01586364|Primary|Incidence of Adverse Events (AEs)||Week 13 (Phone Contact) to Week 56 (Visit 4)|||Participants|||Number
31157|NCT01586338|Secondary|Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 1) state. Any change in the therapy (less use of other therapies, more use of other therapies and no change in use of other therapies) during the study was reported.|Baseline up to Week 26|FAS population.||percentage participants|||Number
31158|NCT01586338|Secondary|Clinical Observer Global Assessment (COGA) Score|COGA (assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant’s osteoarthritis condition. Percentage of participants with different categories of COGA score at baseline,Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.||percentage of participants|||Number
41913|NCT01434823|Primary|MICU Length of Stay|Time from ICU admission to discharge|From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months|||hours||Inter-Quartile Range|Median
31159|NCT01586338|Secondary|Patient Global Assessment (PTGA) Score|PTGA (self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Percentage of participants with different categories of PTGA score at baseline, Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.||percentage of participants|||Number
31160|NCT01586338|Secondary|Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). Each question was measured on a scale of 0-100 mm where lower score represents lower pain (better condition) and higher score represents higher pain. WOMAC A (measure of pain during walking on a flat surface) was sum of first five items with total score ranging from 0-500 mm, Lower score represents lower pain and higher score represents higher pain. WOMAC B (Stiffness) is the sum of the sixth and seventh item, it is in the range of 0-200 mm. WOMAC C (function) is the sum of the eighth to twenty-forth item, the score is in the range of 0-1700 mm.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.||mm||Standard Deviation|Mean
31161|NCT01586338|Secondary|Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 8 and Week 12 (missing data imputed by LOCF)|FAS population.||mm||Standard Deviation|Mean
31162|NCT01586338|Primary|Overview of Adverse Events (AE)|"An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the ‘on treatment period’ (from first dose of study drug until the end of study period). Category AE included participant with both serious and non-serious AE."|Up to Week 26|Safety Set included all participants who received at least one injection of Synvisc.||percentage of participants|||Number
31163|NCT01586338|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])|Full Analysis Set (FAS) included all participants who received at least one injection of Synvisc®. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).||mm||Standard Deviation|Mean
31164|NCT01586312|Secondary|Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)|"Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.~Mean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88."|up to one year|The efficacy endpoint analysis will be based on all patients who have not committed major protocol violations, and have at least one assessment of efficacy of the end graft. 3 patients of the allogenic MSC treatment group were excluded from this analysis because of incomplete measurements.||number of values (range 0-88)||Standard Deviation|Mean
31165|NCT01586312|Secondary|Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)|"Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.~WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.~SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.~The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.~LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).~All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.~Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales."|up to one year|||units on a scale||Standard Deviation|Mean
31166|NCT01586312|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months|Up to one year|"Efficacy evaluable patients (EEP): A patient has been considered evaluable whenever it has undergone the specified interventions (injection of hyaluronic acid or allogeneic MSC).~and~Safety population (SP): The population that includes all evaluable patients who have undergone one of the two study treatments."||participants|||Number
31167|NCT01586026|Primary|The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).|Subjects’ maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.|100 days|||adverse events|||Number
31168|NCT01585987|Secondary|Percentage of Participants With Immune-Related Best Overall Response (irBOR)|IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group were summarized.||percentage of participants|||Number
31169|NCT01585987|Secondary|Overall Survival (OS) at Study Completion|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to end of study, April 2015 (Approximately 28 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.||Months||95% Confidence Interval|Median
31170|NCT01585987|Secondary|Overall Survival (OS) at Primary Endpoint|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.||Months||95% Confidence Interval|Median
31171|NCT01585987|Secondary|Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria|PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).|Randomization up to 91 irPFS events (Approximately 19 months )|All participants randomized to a treatment group were summarized.||Months||95% Confidence Interval|Median
31172|NCT01585987|Primary|Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines|irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.|Randomization up to 91 irPFS events (Approximately 19 months )|All participants who were randomized were summarized.||Months||95% Confidence Interval|Median
31173|NCT01585961|Secondary|Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score|Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding “extremely” limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding “not at all” limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.|Screening to 12 Month Visit|Subset of Safety Population with non-missing AFEQT data at 12 months.||units on a scale||Standard Deviation|Mean
31174|NCT01585961|Secondary|Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data||participants|||Number
31175|NCT01585961|Secondary|Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data||participants|||Number
31176|NCT01585961|Secondary|Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit||12 Month Visit|Subset of Safety Population with non-missing endpoint data.||participants|||Number
31177|NCT01585961|Secondary|Post-procedure AF Symptoms|Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit|12 Month Visit|Subset of Safety Population with non-missing endpoint data.||participants|||Number
31178|NCT01585961|Secondary|Number of Patients With Repeat Ablations||1 year|Safety Population||participants|||Number
31179|NCT01585961|Secondary|Fluid Volume Delivered Via Ablation Catheter||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||mL||Standard Deviation|Mean
31180|NCT01585961|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time that RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||minutes||Standard Deviation|Mean
31181|NCT01585961|Secondary|Mean Number of Radiofrequency (RF) Applications|RF applications is defined as the number of times RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||number of applications||Standard Deviation|Mean
31182|NCT01585961|Primary|Acute Procedural Success|Confirmation of entrance and/or exit block across all targeted pulmonary veins.|Day 0 (procedure)|Safety population||participants|||Number
31183|NCT01585961|Primary|Total Procedure Time||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||minutes||Standard Deviation|Mean
31184|NCT01585961|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.||minutes||Standard Deviation|Mean
31185|NCT01585597|Secondary|Modified Rankin Scale 0-2|"Modified Rankin Score 0=no symptoms~no significant disability~slight disability needs help~moderate disability~moderate serve disability~severe disability 0-2 = good outcome 3-5= poor outcome"|90 days post hospitalization|||participants Modified Rankin Scal 0-2|||Number
31186|NCT01585597|Primary|Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation|Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect|24 Hours|||participants|||Number
31187|NCT01585584|Primary|Sustained Virologic Response (SVR) at 24 Weeks Post Treatment|Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.|24 weeks after treatment|Patients who completed full course of treatment||participants|||Number
31188|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||kg/m^2||Standard Deviation|Mean
31189|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||kg||Standard Deviation|Mean
31190|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||bpm||Standard Deviation|Mean
31191|NCT01585558|Primary|Change From Baseline in DBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
31192|NCT01585558|Primary|Change From Baseline in SBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
31193|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 26|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||kg/m^2||Standard Deviation|Mean
31194|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||kg||Standard Deviation|Mean
31195|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||bpm||Standard Deviation|Mean
31196|NCT01585558|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
31197|NCT01585558|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||mmHg||Standard Deviation|Mean
31198|NCT01585558|Primary|Change From Baseline in Specific Gravity of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||units||Standard Deviation|Mean
31199|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||pH||Standard Deviation|Mean
31200|NCT01585558|Primary|Change From Baseline in Specific Gravtiy of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.||units||Standard Deviation|Mean
31201|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.||pH||Standard Deviation|Mean
31202|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31203|NCT01585558|Primary|Change From Baseline in Hemoglobin Levels||Baseine to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||g/dL||Standard Deviation|Mean
31204|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||(x10(12)/L)||Standard Deviation|Mean
31205|NCT01585558|Primary|Assessment of Hematology Tests|Change from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||(x10(9)/L)||Standard Deviation|Mean
31206|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31207|NCT01585558|Primary|Change From Baseline in Hemogobin Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||g/dL||Standard Deviation|Mean
31208|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||(x10(12)/L)||Standard Deviation|Mean
31209|NCT01585558|Primary|Assessment of Hematology Tests|Change from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||(x10(9)/L)||Standard Deviation|Mean
31210|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
31211|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
31212|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||s||Standard Deviation|Mean
31213|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31214|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31215|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||mg/dL||Standard Deviation|Mean
31216|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31217|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||s||Standard Deviation|Mean
31218|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31219|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31220|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||mg/dL||Standard Deviation|Mean
31221|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||percent change||Standard Deviation|Mean
31222|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
31223|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
31224|NCT01585558|Primary|Assessment of Mammography|Mammography was done for the detection of characteristic masses and microcalcifications in the breast.|Week 52 (Visit 6)|||Participants|||Number
31225|NCT01585558|Primary|Change From Baseline in SHBG Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||nmol/L||Standard Deviation|Mean
31226|NCT01585558|Primary|Change From Baseline in FSH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
31248|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline||Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.||participants|||Number
31227|NCT01585558|Primary|Change From Baseline in LH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
31228|NCT01585558|Primary|Change From Baseline in E2 Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||pg/mL||Standard Deviation|Mean
31229|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
31230|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||ng/dL||Standard Deviation|Mean
31231|NCT01585558|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||nmol/L||Standard Deviation|Mean
31232|NCT01585558|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
31233|NCT01585558|Primary|Change From Baseline in Luteinizing Hormone (LH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||IU/L||Standard Deviation|Mean
31234|NCT01585558|Primary|Change From Baseline in Estradiol (E2) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||pg/mL||Standard Deviation|Mean
31235|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.||Units on a scale||Standard Deviation|Mean
31236|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.||Units on a scale||Standard Deviation|Mean
31237|NCT01585558|Primary|Assessment of Endometrial Safety With a TVU|Mean change in endometrial thickness from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 52 out of 69 subjects in the ospemifene 60 mg group, and 30 out of 49 subjects in the placebo group were analyzed.||mm||Standard Deviation|Mean
31238|NCT01585558|Primary|Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)|Mean change in endometrial thickness from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 50 out of 62 subjects in the ospemifene 30 mg group, 60 out of 69 subjects in the ospemifene 60 mg group, and 37 out of 49 subjects in the placebo group were analyzed.||mm||Standard Deviation|Mean
31239|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 52 (Visit 6)|||U/L||Standard Deviation|Mean
31240|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 26 (Visit 5)|||U/L||Standard Deviation|Mean
31241|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 52 (Visit 6)|||percent change||Standard Deviation|Mean
31242|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 26 (Visit 5)|||percent change||Standard Deviation|Mean
31243|NCT01585558|Primary|Assessment of Endometrial Biopsy|Assessments were based on Blaustein’s classification.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
31244|NCT01585558|Primary|Assessment of Cervical Pap Smear Samples|Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.||Participants|||Number
31245|NCT01585558|Primary|Incidence of Adverse Events (AEs)||Week 20 (Phone Contact) to Week 56 (Visit 7)|||Participants|||Number
31246|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Final Study Visit|||participants|||Number
31247|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Month 3|||participants|||Number
31250|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.||participants|||Number
31251|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Month 3|||participants|||Number
31252|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline|The mean change is reported in micrograms (μg).|Final Study Visit|One finasteride participant's cortisol lab value could not be calculated due to Cortisol, Urine <1.5 ng/mL.||μg||Standard Deviation|Mean
31253|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline|The mean change is reported in micrograms (μg).|Month 3|||μg||Standard Deviation|Mean
31254|NCT01585441|Secondary|Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Final Study Visit|||ng/dL|Participants|Standard Deviation|Mean
31255|NCT01585441|Secondary|Change in Serum Testosterone Concentration at Month 3 Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Month 3|||ng/dL||Standard Deviation|Mean
31256|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Final Study Visit|||pg/mL||Standard Deviation|Mean
31257|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Month 3|||pg/mL||Standard Deviation|Mean
31258|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Final Study Visit|||μm|Participants|Standard Deviation|Mean
31259|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Month 3|||μm|Participants|Standard Deviation|Mean
31260|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Final Study Visit|||decibels|Participants|Standard Deviation|Mean
31261|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Month 3|||decibels|Participants|Standard Deviation|Mean
31262|NCT01585441|Secondary|Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline|Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the “Edit Segmentation” function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.|Month 3|||percent change|Participants|Standard Deviation|Mean
31263|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Final Study Visit|||ETDRS letters|Participants|Standard Deviation|Mean
31264|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Month 3|||ETDRS letters|Participants|Standard Deviation|Mean
31265|NCT01585441|Secondary|Number of Participants Who Withdrew From the Study||Duration of the study, up to 1.5 years|||participants|||Number
31266|NCT01585441|Secondary|Number of Participants With Adverse Reactions Related to the Investigational Product|The outcome measure refers only to events that were classified as related to the investigational product.|Duration of the study, up to 1.5 years|||participants|||Number
31267|NCT01585441|Primary|Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline|This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the “Edit Segmentation” function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.|Month 3|||participants|Participants||Number
31268|NCT01585441|Primary|Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.|This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Month 3|||participants|Participants||Number
31269|NCT01585324|Secondary|Number of Participants With Thrombocytopenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
31270|NCT01585324|Secondary|Number of Participants With Neutropenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
43803|NCT01403090|Primary|Safety|Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.|30 days|||participants|||Number
31272|NCT01585324|Secondary|Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR|The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||g/L||Standard Deviation|Mean
31273|NCT01585324|Secondary|Number of Participants With Decrease in Hemoglobin|The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||participants|||Number
31274|NCT01585324|Primary|Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR|Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Baseline and Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.||grams per liter (g/L)||Standard Deviation|Mean
31275|NCT01585324|Primary|Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment|SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.|24 weeks after the end of treatment (72 weeks)|ITT population included all enrolled participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
31276|NCT01585272|Secondary|Percentage of Patients Successfully Titrated to Rivastigmine Patch 10 cm^2|The percentage of patients successfully titrated to rivastigmine patch 10 cm2|Baseline through week 52|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.||Percentage of participants|||Number
31277|NCT01585272|Secondary|The Discontinuation Rate Due to the Treatment Switching From Oral Capsule to Rivastigmine Patch Treatment|The discontinuation rate due to the treatment switching from oral capsule to patch treatment. For patients who discontinue earlier due to intolerance of patch treatment, the proportion will be analyzed. Both the discontinuation rate of 5 cm2 and 10 cm^2 patch therapy will be presented.|Baseline through week 52|Of the patients treated, N=121, number of patients analyzied were those who received 5cm patch (n=114) and those who received 10cm patch (n=96)||Participants|||Number
31278|NCT01585272|Secondary|Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)|The changes in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) of patients with Alzheimer’s disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm^2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. ADAS-Cog has been used as the major cognitive measure of anti-dementia drugs. The total score range is 0 to 70 points, with higher scores indicating greater cognitive impairment. The assessments will be conducted at Visit, 2, 8, 11 and 17 (Week 4 (baseline), 16, 28 and 52).|Baseline, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy.||Score||Standard Deviation|Mean
31279|NCT01585272|Secondary|Change From Baseline in Mini-Mental Status Examination (MMSE)|The changes in Mini-Mental Status Examination (MMSE) of patients with Alzheimer’s disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. MMSE is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial ability and language. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. The assessments will be conducted at Visit 1, 2, 8, 11 and 17 (screening, Week 4 (baseline), 16, 28 and 52).|Baselin, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy||Score||Standard Deviation|Mean
31280|NCT01585272|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through the first 28-week treatment period|Baseline through week 28|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.||Participants|||Number
31281|NCT01585038|Secondary|Oxidative Stress Markers|Change in F2-isoprostane levels|Change from baseline to 4 weeks|||pg/mL||Standard Deviation|Mean
31282|NCT01585038|Secondary|Endothelial Activation Markers|Change in soluble vascular cell adhesion molecule-1 levels|Change from baseline to 4 weeks|||pg/mL||Standard Deviation|Mean
31283|NCT01585038|Secondary|Inflammatory Markers|Change in high sensitivity C-reactive protein levels|Change from baseline to 4 weeks|||mg/L||Standard Deviation|Mean
31284|NCT01585038|Primary|Change in Flow-mediated Dilation of the Brachial Artery|This is a measure of in vivo endothelial function|Change from baseline to 4 weeks|||absolute percentage change||Standard Deviation|Mean
31285|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population|||||
31316|NCT01584648|Secondary|Number of Participants With a Confirmed Response (Complete Response or Partial Response)|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|From randomization until the first documented complete response or partial response (average of 9 study months)|ITT Population. Only participants with measurable disease at Baseline per RECIST were analyzed.||Participants|||Number
31286|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
31287|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
31288|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population|||||
31289|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
31290|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Week 1 and Week 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.||Scores on a scale||Standard Deviation|Mean
31291|NCT01584843|Secondary|Duration of Effect|Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after injection]/absolute angle [strabismus angle at Baseline minus the strabismus angle at maximum change]) multiplied by 100.|Up to Week 48 after the final injection of the FTP (up to Study Week 52)|FAS1 Population||Days||95% Confidence Interval|Median
31292|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population||Percent change in prism dioptre||Standard Deviation|Mean
31293|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP|FAS1 Population||Percent change in prism dioptre||Standard Deviation|Mean
31294|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle ([strabismus angle at Baseline minus strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population||Percent change in prism dioptre||Standard Deviation|Mean
31295|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 population.||prism dioptre||Standard Deviation|Mean
31296|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position were summarized for observed cases at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups).|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
31297|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position at Week 1 and Week 4 of the FTP were summarized for observed cases without imputation of missing values.|Weeks 1 and 4 of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
31298|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population: all participants who were included in the FAS1 Population, received reinjection of the investigational product, and had at least one efficacy assessment after the reinjection||prism dioptre||Standard Deviation|Mean
31299|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
31300|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 1minus the value at Baseline.|Baseline and Week 1 of the FTP|FAS1 Population||prism dioptre||Standard Deviation|Mean
31301|NCT01584843|Primary|Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters [m]) and the near-view strabismus angle (measured at a distance of 33 centimeters [cm]). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline.|Baseline and Week 4 of the FTP|Full Analysis Set (FAS1) Population: all participants who were randomized and had at least one post-Baseline efficacy assessment. Values were summarized for OC of the FTP without imputation of missing values. Only those participants available at the specified time points were analyzed.||prism dioptre||Standard Deviation|Mean
31302|NCT01584648|Secondary|Plasma Concentrations of Dabrafenib and Its Metabolites|Blood samples were collected for PK analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Plasma concentrations of dabrafenib (GSK2118436) and its metabolites (GSK2285403, GSK2298683, and GSK2167542) were determined using the currently approved analytical methodology.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|PK Population.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
31303|NCT01584648|Secondary|Plasma Concentrations of Trametinib|Blood samples were collected for Pharmacokinetic (PK) analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|Pharmacokinetic (PK) Population: all participants included in the safety population for whom a PK sample was obtained and analyzed. Only participants with data available at the specified time points were analyzed.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
31304|NCT01584648|Secondary|Number of Participants With Incidence of Squamous Cell Carcinoma|Participants were evaluated for the event of squamous cell carcinoma including Keratoacanthoma.|From Baseline up to end of study (average of 9 study months)|Safety Population||Number of events|||Number
31305|NCT01584648|Secondary|Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as any increase; no change; and any decrease and as 0-10 decrease, 10 - 19 decrease, >= 20 decrease, >=10 decrease and >= lower limit of normal (LLN), >=10 decrease and <LLN, >10 decrease and <LLN, >= 20 decrease and >= LLN, >= 20 decrease and <LLN. Only those participants with LVEF values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
31306|NCT01584648|Secondary|Number of Participants With a Worse-case On-therapy Change From Baseline in the Bazett's QTc to Grade 2 or Grade 3|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. Bazett's QTc is categorized as: Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (>=501 msec). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with Bazett's QTc values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
31307|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
31308|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with blood pressure values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
31309|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. Only those participants with heart rate values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
31317|NCT01584648|Secondary|Overall Survival (OS)|OS is defined as the interval of time (in months) between the date of randomization and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From randomization until death due to any cause (average of 9 study months)|ITT Population||Months||95% Confidence Interval|Median
31408|NCT01582243|Secondary|Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24|PPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||mg/dL||Standard Deviation|Mean
31310|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Clinical Chemistry Parameters|Clinical chemistry tests where the toxicity grade is not defined by NCI-CTCAE includes chloride, creatinine clearence, lactate dehydrogenase, urea, protein and carbon dioxide. Change from Baseline is categorized as decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
31311|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Hematology Parameters|Hematology tests where the toxicity grade is not defined by NCI-CTCAE includes basophils, eosinophils and monocytes. Change from Baseline is categorized as a decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
31312|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Hematology Parameters|Hematology data were summarized according to NCI-CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe, or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
31313|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters|Clinical chemistry data were summarized according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, glucose, potassium, sodium, creatinine and phosphate. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
31314|NCT01584648|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Protocol specific SAEs included: ALT≥3XULN and total bilirubin ≥2XULN (35% direct) or ALT ≥3XULN and INR >1.5 (if INR is measured); any new malignancy with a histology different from the primary tumor; left ventricular ejection fraction that met stopping criteria; central serous retinopathy or retinal vein occlusion; pyrexia accompanied by ≥grade 3 hypotension, or hypotension that is clinically significant as judged by the investigator, dehydration requiring IV fluids, or severe rigor/chills. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the time the first dose of study treatment administered until 30 days after discontinuation of study treatment (average of 9 study months)|Safety Population: all randomized participants who received at least one dose of study medication and were based on the actual treatment received if this differed from that to which the participant was randomized.||Participants|||Number
31315|NCT01584648|Secondary|Duration of Response for Participants With a Confirmed Response (Complete Response or Partial Response)|Duration of response is defined as the time (in months) from the first documented complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm) until disease progression (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. PD was based on the radiological evidence by investigator.|From the time of the first documented response (CR or PR) until disease progression (average of 9 study months)|ITT population. Only those participants with a confirmed CR or PR were analyzed (with or without measurabe disease at Baseline).||Months||95% Confidence Interval|Median
32907|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.||pg*hr/mL||Standard Deviation|Mean
31318|NCT01584648|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time (in months) from the date of randomization to the first documented occurrence of PD or death. Investigator PFS was summarized per response evaluation criteria in solid tumors (RECIST, version 1.1) which is a set of published criteria defining when cancer patients improve (respond), stay the same (stable) or worsen (progress). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. For participants who had not progressed or died at the time of the analysis, censoring was performed at the last adequate disease assessment.|From randomization until the earliest date of disease progression (PD) or death due to any cause (average of 9 study months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not they received the study treatment. Any participant who received a treatment randomization number was considered to have been randomized.||Months||95% Confidence Interval|Median
31319|NCT01584544|Primary|Number of Participants Experienced Dose Limited Toxicity|Dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment|up to 7 weeks from start of the treatment|||participants|||Number
31320|NCT01584518|Primary|Length of Stay|The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay|From date of admission until date of discharge, assessed up to 1 month|||days||Standard Deviation|Mean
31321|NCT01584479|Secondary|Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories||10 and 15 years||||||
31322|NCT01584479|Secondary|Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.||10 and 15 years||||||
31323|NCT01584479|Secondary|Change in Periodontal Surgery Claims||10 and 15 years||||||
31324|NCT01584479|Secondary|Change in Total Periodontal Claims During the Monitoring Period||10 and 15 years||||||
31325|NCT01584479|Secondary|Change in Total Dental Claims During Monitoring Period||10 and 15 years||||||
31326|NCT01584479|Primary|Percentage of Participants With Tooth Loss Over 16 Year Period|Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.|16 years|||percentage of participants|||Number
31327|NCT01584232|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used.||percentage of participants|||Number
31328|NCT01584232|Secondary|Change From Baseline in Body Weight at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
31329|NCT01584232|Secondary|Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects and baseline SMBG as a covariate.|Baseline, Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
31330|NCT01584232|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
31331|NCT01584232|Secondary|Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.||percentage of participants|||Number
31332|NCT01584232|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used.||percentage of HbA1c||Standard Error|Least Squares Mean
31333|NCT01583894|Primary|Multi-site Pain Index|"Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.~MSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions."|single-visit|MSPI was calculated using multiple pain descriptors which were obtained from pain drawings. 810 of the 813 patients that completed the study provided complete pain drawing data, and so MSPI could be calculated only in 810 patients.||units on a scale||Standard Deviation|Mean
31334|NCT01583647|Primary|Plasma Cmax of Nicotinuric Acid (NUA)||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
31335|NCT01583647|Primary|Total Urinary Excretion of Niacin and Niacin Metabolites||Predose on Day 1 up to 72 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
31336|NCT01583647|Primary|Plasma Maximum Concentration (Cmax) of Laropiprant||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
31337|NCT01583647|Primary|Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant||Predose Day 1 up to 24 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.|||||
31338|NCT01583530|Secondary|Number of Participants Who Experienced Adverse Events|Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).|Up to Day 119|Analyses were performed on the as-treated population, defined as the set of all participants who received at least 1 partial or full dose of treatment with the assignment to treatment group that was based on the actual treatment administered to the participants.||participants|||Number
31339|NCT01583530|Secondary|Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage bioavailability||90% Confidence Interval|Mean
31340|NCT01583530|Secondary|Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
31341|NCT01583530|Secondary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
31342|NCT01583530|Secondary|Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
31343|NCT01583530|Primary|Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage bioavailability||90% Confidence Interval|Mean
49896|NCT01323270|Secondary|Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens||1 month after Vaccination 1|||International Units per milliliter||95% Confidence Interval|Geometric Mean
31344|NCT01583530|Primary|Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
31345|NCT01583530|Primary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
31346|NCT01583530|Primary|Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
31347|NCT01583530|Secondary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Standard Deviation|Mean
31348|NCT01583530|Primary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||days||Full Range|Median
31349|NCT01583452|Secondary|Time to Tolerate Feedings (Oral Intake)|The time between the end of surgery to the moment in which the patient can tolerate the intake of fluids or any type of food.|End of surgery to oral intake tolerance (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
31350|NCT01583452|Secondary|Time to First Bowel Movement|The time between the end of surgery and the moment in which the patient presents first bowel movement.|End of surgery to first bowel motion (from 1 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
31351|NCT01583452|Secondary|Time to First Flatus|The time between the end of surgery and the moment in which the patient passes first flatus|End of surgery to first flatus (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
31352|NCT01583452|Primary|Post-Operative Hospital Stay|The time between the end of surgery and hospital discharge, measured in hours|End of surgery to hospital discharge (from 4 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.||hours||Standard Deviation|Mean
31353|NCT01583374|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period|A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|During placebo-controlled period; up to week 24|Safety population includes all participants who were randomized and received at least one dose of IP. Includes data through Week 16 for placebo-treated and apremilast 20 mg BID treated participants who escaped early and data up to Week 24 for all other participants.||participants|||Number
31354|NCT01583374|Secondary|Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 260|The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) is a scoring method used by experts to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine.|Baseline and Week 260||12/2019||||
31355|NCT01583374|Secondary|Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104|The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) is a scoring method used by experts to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine.|Baseline and Week 104||12/2019||||
49897|NCT01323270|Primary|Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen||1 month after Vaccination 1|||percentage of participants|||Number
31356|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24|The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) are measured and normalized on 0 to 10 unit NRS. The average of these scores is the total BASMI score, with a higher value indicating more severe limitation in spinal mobility|Baseline and Week 24||12/2019||||
31357|NCT01583374|Secondary|Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement|Baseline and Week 24||12/2019||||
31358|NCT01583374|Secondary|Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) at Week 24|The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis (AS) on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consists of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0–18 with higher scores indicating worse quality of life|Baseline and Week 24||12/2019||||
31359|NCT01583374|Secondary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) at Week 24, Compared Between Apremilast 20 mg and Placebo|"ASAS 20 is defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:~Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active~Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = “no pain” and the right-hand box = “most severe pain”~Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability~Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 24||12/2019||||
31360|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a participant self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3)peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease.|Baseline and Week 24||12/2019||||
31361|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a participant self-administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses a participants' degree of mobility and functional ability. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting the participants' ability to cope with everyday life. The participant will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 10 questions, on which the left-hand box of 0 represents “easy,” and the right-hand box represents “impossible.” The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability.|Baseline and Week 24||12/2019||||
31362|NCT01583374|Primary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) for the Comparison Between Apremilast 30 mg BID and Placebo at 16 Week of Treatment|"ASAS 20 is defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:~Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active~Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = “no pain” and the right-hand box = “most severe pain”~Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability~Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 16|The mITT population who were randomized to apremilast (APR) 30 mg BID or placebo and received at least one dose of investigational product. The APR 20mg dose was an exploratory endpoint.||percentage of participants|||Number
31363|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research].|Month 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
32908|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.||hr||Full Range|Median
31364|NCT01582854|Secondary|Beck Depression Inventory, Version II (BDI-II) at Months 3, 6 and 12|"The BDI-II is a 21-question multiple-choice self-report inventory for measuring the severity of depression. is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Each answer is scored on a scale 0 (best) to 3 (worst). Total scores range from 0 to 63 with higher scores indicating more severe depression.~BDI II scale:~0-13 minimal depression~14-19 mild depression~20-28 moderate depression~29-63 severe depression"|Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Deviation|Mean
31365|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12|The EuroQoL included a visual analogue scale where the subject marks how they feel at that moment on a scale from 0 (the worst health that can be imagined) to 100 (the best health that can be imagined).|Months 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Deviation|Mean
31366|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 12|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
31367|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 6|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
31368|NCT01582854|Secondary|Barthel Index at Months 3 and 6|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include: feeding, transfers (bed to chair and back), grooming, toilet use, bathing, mobility (walking on level surface), going up and down stairs, dressing, continence of bowels and bladder. Each performance item is rated, with a given number of points assigned to each level or ranking. Individual scores are summed for a total possible scores ranging from 0 (worst) to 100 (best) with higher scores indicating more independent daily living.|Months 3 and 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Full Range|Median
31369|NCT01582854|Secondary|Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12|The NIHSS is a tool to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) to 4 (some level of impairment). The individual scores from each item are summed in order to calculate total possible NIHSS score from 0 (best) to 42 (worst). A negative change from Baseline indicates improvement. ANCOVA model was used for analyses that included treatment and pooled centre as factors and Baseline NIHSS score as a covariate.|Baseline and End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Error|Least Squares Mean
31370|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research]. The proportion of participants with dementia was compared between treatments using a Fisher’s exact test.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of participants|||Number
31371|NCT01582854|Secondary|Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months|Responder was defined as an improvement of 4 or more from baseline on the ADAS-cog+ scale using observed data. The proportion of responders was compared between treatments using a chi-square test.|Baseline and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||percentage of responders|||Number
31372|NCT01582854|Secondary|Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12|"The MoCA is a rapid screening test to assess mild cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal. A positive change from Baseline (BL) indicates improvement.~ANCOVA model was used for analyses that included treatment and pooled centres as factors, plus years of education and baseline MoCA score as covariates."|Baseline, End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.||score on a scale||Standard Error|Least Squares Mean
31387|NCT01582490|Secondary|Total Postsurgical Opioid Consumption in the Surgical Center|Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.|10 days|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||mg||Standard Deviation|Mean
31409|NCT01582243|Secondary|Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24|FPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||mg/dL||Standard Deviation|Mean
31373|NCT01582854|Secondary|Change From Baseline in ADAS-cog+ at Month 3 and Month 12|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.~ANCOVA model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Months 3 and 12|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score.||score on a scale||Standard Error|Least Squares Mean
31374|NCT01582854|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.~Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Month 6|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score and missing total scores (where all item scores missing) imputed by last observation carried forward.||score on a scale||Standard Error|Least Squares Mean
31375|NCT01582789|Primary|Comfortable Wearing Time - Second Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up||hours||Standard Deviation|Mean
31376|NCT01582789|Primary|Comfortable Wearing Time - First Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up||hours||Standard Deviation|Mean
31377|NCT01582789|Primary|Comfort - Second Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|1 subject withdrew from study.||units on a scale||Standard Deviation|Mean
31378|NCT01582789|Primary|Comfort - First Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|one drop out at first 2 week follow up||units on a scale||Standard Deviation|Mean
31379|NCT01582789|Primary|Comfort - Second Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up||units on a scale||Standard Deviation|Mean
31380|NCT01582789|Primary|Comfort - First Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up||units on a scale||Standard Deviation|Mean
31381|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|Day 10 after surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||participants|||Number
31382|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||participants|||Number
31383|NCT01582490|Secondary|Incidence of Opioid-Related Adverse Events|The incidence of adverse events that were assessed as opioid-related|Through 10 Days Post Surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||participants|||Number
31384|NCT01582490|Secondary|Time to Hospital Discharge Being Written|The time (hours) to the hospital discharge being written for subjects in each group,|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||hours||Standard Deviation|Mean
31385|NCT01582490|Secondary|Pain Intensity Assessment at the Time of Hospital Discharge|Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.||units on a scale||Standard Deviation|Mean
31386|NCT01582490|Secondary|Pain Intensity Assessment Upon Waking in the PACU|Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.|Upon waking in the PACO post surgery|There were 9 subjects in the Infiltration - EXPAREL efficacy analysis set and 8 subjects in the Instillation - EXPAREL efficacy analysis set.||units on a scale||Standard Deviation|Mean
31388|NCT01582490|Primary|Duration of Analgesia|The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.|10 days|Of the 8 subjects in the Infiltration - EXPAREL group (efficacy analysis set), 5 were censored, leaving 3 subjects who were administered an opioid. Of the 9 subjects in the Instillation - EXPAREL group (efficacy analysis set), 7 were censored, leaving 2 subjects who were administered an opioid.||hours|||Number
31389|NCT01582477|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control|Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)|24 hours, 72 hours, and day 10|72 hour reported subject satisfaction at||units on a scale||Standard Deviation|Mean
31390|NCT01582477|Secondary|Incidence of Prespecified Opioid-related Adverse Events|Number of subjects|Until hospital discharge order was written, anticipated at 24 hours.|||Number of subjects|||Number
31391|NCT01582477|Secondary|Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.|Number of pills|48, 72, 96 hours, and 10 days|96 hour measurement given||Number of tablets||Standard Deviation|Mean
31392|NCT01582477|Secondary|Physician/Healthcare Professional Assessed Postsurgical Pain|11-point NRS (0-10, 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24 hours after TAP|24 hour NRS is reported||units on a scale||Standard Deviation|Mean
31393|NCT01582477|Secondary|Subject Reported Postsurgical Pain|11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP|Data shown are from the 72-hour time point||units on a scale||Standard Deviation|Mean
31394|NCT01582477|Primary|The Duration of Abdominal Analgesia From Infiltration Into the TAP||First postsurgical administration of an opioid|Per protocol||hours||Inter-Quartile Range|Median
31395|NCT01582308|Secondary|Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax)|Measurement of the time to the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.||hr||Full Range|Median
31396|NCT01582308|Secondary|Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax)|Measurement of the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.||nM||Geometric Coefficient of Variation|Geometric Mean
31397|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID|AUC 0-12hr is the area under the plasma drug concentration-time curve calculated for the 12 hour interval after the Day 5 morning dose for the vildagliptin 50 mg BID dose only.|Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5|All participants who had at least at least one measurement. This outcome measure is for the vildagliptin 50 mg BID dose only; therefore, results are only presented for vildagliptin 50 mg BID dose.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
31398|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr)|AUC 0-24hr is the area under the plasma drug concentration-time curve calculated for the 24 hour interval after the Day 5 morning dose.|Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5|All participants who had at least at least one measurement.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
31399|NCT01582308|Primary|Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough|Percent inhibition of DPP-4 activity at 24 hours after the Day 5 morning dose (i.e., at trough) was determined by analysis of blood samples collected from the study participants.|24 hours following the final morning dose on Day 5|All participants who had at least at least one measurement.||Percent inhibition||95% Confidence Interval|Least Squares Mean
31400|NCT01582282|Primary|Triglyceride Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat||mg/dL||Standard Error|Mean
31401|NCT01582282|Primary|Total Cholesterol Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat||mg/dL||Standard Error|Mean
31402|NCT01582282|Primary|Change From Baseline in Fasting LDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|The LDL cholesterol values for two subjects at week 12 were unreportable.||mg/dL||Standard Error|Mean
31403|NCT01582282|Primary|Change From Baseline in Fasting HDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat||mg/dL||Standard Error|Mean
31404|NCT01582282|Primary|Change From Baseline in Fasting HbA1c|Change is defined as Post-Baseline minus Baseline|12 weeks|||percentage of total hemoglobin||Standard Error|Mean
31405|NCT01582282|Primary|Change From Baseline in Fasting Glucose|Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value|12 weeks|Intent-to-Treat||mg/dL||Standard Error|Mean
31406|NCT01582243|Secondary|The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment|Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.|week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||percentage of participants|||Number
31407|NCT01582243|Secondary|Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week|Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.|Baseline, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||mg/dL||Standard Deviation|Mean
31493|NCT01580072|Secondary|Number of Bed Days for Hospitalised Patients||12 months|||bed days||Standard Deviation|Mean
31410|NCT01582243|Secondary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||percentage||Standard Deviation|Mean
31411|NCT01582243|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement||percentage||Standard Deviation|Mean
31412|NCT01582178|Primary|Cecal Intubation Time|= time between introduction of the colonoscope into the anus and reaching the cecum.|1-30|||minute||Standard Deviation|Mean
31413|NCT01582178|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months||||||
31414|NCT01582178|Primary|Cecal Intubation Time||3 months||||||
31415|NCT01582139|Secondary|Time in Range|Percent time spent within target (70-180 mg/dL) range.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.||percentage of time spent in range||Standard Error|Mean
31416|NCT01582139|Secondary|Average Glucose Drop|Average glucose drops at specific time points after the onset of exercise; defined as the difference between plasma glucose at onset of exercise and the glucose values reached at 40 and 60 min post onset of exercise.|26 hours (2x admissions)|The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented.||mg/dL||Standard Deviation|Mean
31417|NCT01582139|Secondary|Low Blood Glucose Index|"A measure of the risk of hypoglycemia. It quantifies the frequency and the extent of low BG readings.~A LBGI < 2.5 is associated with a low-risk of hypoglycemia, LBGI 2.5-5 is associated with a moderate risk of hypoglycemia, and LBGI > 5 is associated with a high-risk of hypoglycemia."|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.||index score||Standard Error|Mean
31418|NCT01582139|Primary|Hypoglycemic Events|Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.||hypoglycemic events|||Number
31419|NCT01582100|Primary|Incidence of Nausea in Patients With GERD|number of events of nausea with or without vomiting in patients with GERD in 4 weeks|4 weeks||||||
31420|NCT01581931|Primary|Maximum Concentration (Cmax) of Metformin|Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||ng/mL||Geometric Coefficient of Variation|Geometric Mean
31421|NCT01581931|Primary|Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin|AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
31422|NCT01581931|Secondary|Terminal Half-life t1/2 of Metformin|The terminal half-life of metformin in plasma is denoted by t1/2.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||Hours||Geometric Coefficient of Variation|Geometric Mean
31423|NCT01581931|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Time from dosing to the maximum concentration of metformin in plasma.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||Hours||Full Range|Median
31424|NCT01581931|Secondary|Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin|AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
31425|NCT01581684|Primary|Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests|Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).|From drug administration until end of trial examination, up to 13 days|Treated set||participants|||Number
31426|NCT01581684|Primary|Number of Participants With Drug Related AEs|Number of participants with drug related adverse events (AEs)|From drug administration until end of trial examination, up to 13 days|Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment||participants|||Number
31427|NCT01581684|Secondary|Amount of Analyte Eliminated in Urine From 0 to 4 (Ae0-4)|Amount of analyte eliminated in urine from the time point 0 to time point 4|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set||nmol||Geometric Coefficient of Variation|Geometric Mean
31494|NCT01580072|Primary|Number of Inpatient Stays||12 months|||inpatient stays||Standard Deviation|Mean
31428|NCT01581684|Secondary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
31429|NCT01581684|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set||h||Full Range|Median
31430|NCT01581684|Secondary|Maximum Measured Concentration (Cmax )|Maximum measured concentration of the analyte in plasma|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment and who provided at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK||nmol/L||Geometric Coefficient of Variation|Geometric Mean
31431|NCT01581658|Primary|Maximum Concentration|Maximum concentration of the analyte in plasma|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients||nmol/L||Geometric Coefficient of Variation|Geometric Mean
31432|NCT01581658|Primary|Area Under the Concentration Time Curve of the Analyte in Plasma|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
31433|NCT01581658|Primary|Change From Baseline in Total Urinary Glucose Excretion (UGE)|change from baseline in total urinary glucose excretion (UGE) to 24 hours|baseline and 24 hours|Treated patients||mg||95% Confidence Interval|Least Squares Mean
31434|NCT01581437|Secondary|Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation|percentage of all patients who had ablation perfornmed|1 year|all patients participating undergo mapping using the 64 pole basket catheter||percentage of all patients undergoing ab|||Number
31435|NCT01581437|Secondary|Single-procedure Freedom From Atrial Fibrillation|percentage of patients without prior ablation|one year|percentage of patients who underwent mapping with 64 pole basket catheter||percentage of patients with no prior abl|||Number
31436|NCT01581437|Secondary|Mean Time to Recurrence of Atrial Fibrillation|mean time to recurrence of atrial fibrillation|1 year|patients participating undergo mapping using the 64 pole basket catheter||days||Full Range|Mean
31437|NCT01581437|Secondary|Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs|To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.|30 min|||participants|||Number
31438|NCT01581437|Primary|Average Number of Rotors/Focal Drivers in Diverse Locations||30 minutes|||rotor/focal drivers||Standard Deviation|Mean
31439|NCT01581437|Primary|Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources|percentage of patients|30 minutes|||percentage of patients|||Number
31440|NCT01581437|Primary|Time to Ablation of All Sources|total time taken to ablate all sources of rotors/focal sources in driver locations|30 minutes|patients participating undergo mapping using the 64 pole basket catheter||minutes||Standard Deviation|Mean
31441|NCT01581437|Primary|Percentage of Drivers in Right Atrial|To determine where atypical areas of drivers might be.|30 min|||percentage of rotor sources|||Number
31442|NCT01581307|Secondary|Overall Response Rate (ORR)|The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups.|Up to 29 months|All participants evaluable at time of analysis||Participants|||Count of Participants
31443|NCT01581307|Secondary|Rate of Progression Free Survival (PFS)|PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis||Participants|||Count of Participants
31444|NCT01581307|Primary|Median Overall Survival (OS)|OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis||months||95% Confidence Interval|Median
31445|NCT01581021|Secondary|Mobilization and Pain Survey|Using a numeric rating scale (0 = no pain and 10 = unbearable pain), patients were asked to estimate their experienced pain while at rest and when mobile by specifying a number on the scale.|24 months post-operative|||units on a scale||Standard Deviation|Mean
31446|NCT01581021|Primary|Scoliosis Research Society-30 Survey|Participants were administered a validated survey for evaluating patient quality of life and satisfaction with treatment. Total SRS-30 scores (max = 150) and the domains: function (max = 35), pain (max = 30), self-image (max = 45), mental health (max = 25), and satisfaction with management (max = 15) were analyzed on a scale from 1 (worst) to 5 (best). The mean was obtained by dividing maximum possible score by the number of questions answered.|24 months post-operative|||units on a scale||Standard Deviation|Mean
31447|NCT01581021|Primary|Rotation|The degree to which the spinal column is rotated from its normal position will be assessed.|24 months post-operative|||degree||Standard Deviation|Mean
31448|NCT01581021|Primary|Main Thoracic Cobb|X-rays measures the degree of curve in the thoracic spine.|24 months post-operative|||Degree||Standard Deviation|Mean
31544|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31449|NCT01581008|Secondary|Adherence to the Study Protocol (CASA Arm Only)|"We will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as:~how often is depression addressed with a treatment plan?~how often are care team recommendations placed as orders in the medical record?~how often are orders completed?"|3 months|"A variety of process information was analyzed. Please see Bekelman DB et al, Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial Journal of Palliative Medicine 2014, PMID 14329424 for details."||%in arm severe target symptoms addressed|||Number
31450|NCT01581008|Secondary|Participation Rates|We will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.|7 months|The total population approached was 72 people. 31 consented to be randomized for a participate rate of 43%. Of these, one was a screen failure, and 17 and 13 were randomized to arm 1 and arm 2 respectively.||participants|||Number
31451|NCT01581008|Secondary|Preliminary Estimate of Intervention Effect (Summative Evaluation)|Pre-post-measurement of outcomes using KCCQ, ESAS, PHQ-9, GAD-7, adoption of orders by PCPs, Spiritual well-being|3 months||||||
31452|NCT01581008|Primary|Cohort Retention|Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.|3 months|||participants|||Number
31453|NCT01580995|Primary|Change in HCV RNA Viral Load|Measure change in HCV RNA viral load in treatment group as compared with placebo|Baseline, 12 weeks|patients who completed 12 weeks of follow up||log(IU/mL)||Standard Deviation|Mean
31454|NCT01580904|Secondary|LDL Cholesterol|average LDL cholesterol over 24 weeks|Up to 24 weeks|||mg/dL||Standard Deviation|Mean
31455|NCT01580904|Secondary|Total Cholesterol|average total cholesterol over 24 weeks|Up to 24 weeks|||mg/dL||Standard Deviation|Mean
31456|NCT01580904|Primary|Fasting Glycemia|average fasting glycemia over 24 weeks|Up to 24 weeks|||mg/dL||Standard Deviation|Mean
31457|NCT01580904|Primary|Glycated Hemoglobin|average glycated hemoglobin over 24 weeks|Up to 24 weeks|Data are glycated hemoglobin means of all patients per group.||percent (%)||Standard Deviation|Mean
31458|NCT01580618|Secondary|Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion|This measures the number of hospital days for each participant after they were started on their infusion therapy.|30 days|||days||Standard Deviation|Mean
31459|NCT01580618|Secondary|Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion.||30 days|||percentage of participants|||Number
31460|NCT01580618|Secondary|Percentage of Patients Who Fail Initial Therapy (TNK or Saline) Who at the Request of the Hospital-based Doctor Are Then Switched to the Other Arm/Group AND Who Then Achieve Satisfactory Drainage (Saline or TNK) Therapy.|Only one patient who was on normal saline arm/group was switched (by request of the referring hospital-based doctor) to TNKase, but did not have complete clearing of their effusion. No patient in the TNKase arm/group was switched to normal saline. Therefore, we have removed the TNKase arm/group from this portion of the analysis since there are no participants in this group to analyze this outcome measure.|3-5 days|||percentage of participants|||Number
31461|NCT01580618|Primary|Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage|This is the percentage of patients in each arm of the study (Normal saline or TNKase) who suffered a hemorrhagic complication directly associated with instillation of normal saline or TNKase|3-5 days|||percentage of participants|||Number
31462|NCT01580618|Primary|Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy.||3-5 days|||percentage of participants|||Number
31463|NCT01580592|Secondary|Safety of Patients Treated With Omalizumab|This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|day 70||08/2016||||
31464|NCT01580592|Primary|Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo|The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.|day 70|female and male||degree celcius||Standard Deviation|Mean
31465|NCT01580488|Secondary|Change in Skin Thickness From Baseline to Day 22|Change in skin thickness – echo-poor band measured by ultrasound from baseline to end of treatment|Baseline to Day 22|||millimeters||Standard Deviation|Mean
31466|NCT01580488|Secondary|Change in Lesion Thickness From Baseline to Day 22|Change in total skin thickness measured by ultrasound from baseline to end of treatment|Baseline to Day 22|||millimeters||Standard Deviation|Mean
31467|NCT01580488|Secondary|Change in Scaling From Baseline to Day 22|Investigator’s rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
31468|NCT01580488|Secondary|Change in Infiltration From Baseline to Day 22|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
31469|NCT01580488|Secondary|Change in Erythema From Baseline to Day 22|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
31470|NCT01580488|Primary|Change in the Total Clinical Score From Baseline to Day 22|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)|Baseline to Day 22|||units on a scale||Standard Deviation|Mean
31471|NCT01580423|Primary|Unpleasantness of Breathlessness|"Time-weighted averages of unpleasantness of breathlessness.~Subject rating of unpleasantness of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
51745|NCT01300286|Secondary|Cryoprecipitate Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||mL||Standard Deviation|Mean
31472|NCT01580423|Secondary|Intensity of Pain|"Time-weighted averages for intensity of pain.~Subject rating of intensity of pain on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity was obtained during immersion of the subject's non-dominant hand in cold water."|Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
31473|NCT01580423|Primary|Intensity of Breathlessness|"Time-weighted averages of intensity of breathlessness.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
31474|NCT01580306|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events.|drug administration until end-of-study examination (7 to 14 days after drug administration)|treated set||participants|||Number
31475|NCT01580306|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 2 weeks|treated set||participants|||Number
31476|NCT01580306|Primary|Cmax|maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
31477|NCT01580306|Primary|AUC0-∞|"area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.~In this endpoint, the data of AUC0-∞ show inter-individual variabilities."|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration|Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
31478|NCT01580098|Secondary|Number of Hospitalisations|The number of inpatient stays comparing intervention and control group was conducted.|12 months|||number of inpatient stays||Standard Deviation|Mean
31479|NCT01580098|Secondary|Presence of Diabetic Complications||12 months|No data about the presence of diabetic complications could be analysed at the end of the study, no data was collected for this secondary outcome.|||||
31480|NCT01580098|Secondary|Medication Changes|Insulin, Change? -> Yes/No|12 months|No data about medical changes could be analysed at the end of the study, no data were collected.|||||
31481|NCT01580098|Secondary|Body Weight||12 months|baseline demographic characteristics; No patients of the Nurse-Monitoring Group finished the study, as a consequence no Body weight after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||kilograms||Standard Deviation|Mean
31482|NCT01580098|Secondary|Blood Lipids||12 months|Not all Participants delivered reliable data; Measurements at the beginning of the trial and after 12 months; No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood lipids after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||mg/dL||Standard Deviation|Mean
31483|NCT01580098|Secondary|Blood Pressure||12 months|Not all Participants delivered data, reliable data was used. No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood pressure after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||mmHg||Standard Deviation|Mean
31484|NCT01580098|Primary|HbA1c|HbA1c was taken at the beginning of the study and after 12 months.|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no HbA1c after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||HbA1c [%]||Standard Deviation|Mean
31485|NCT01580098|Primary|Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status.~Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests."|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no SF36 after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.||units on a scale (General health score)||Standard Deviation|Mean
31486|NCT01580072|Secondary|BODE Index (Carinthia)||12 months||||||
31487|NCT01580072|Secondary|St. George's Respiratory Questionnaire SGRQ (Carinthia)|"The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.~Scores are calculated for three domains:~Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.~A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos"|12 months|||units on a scale||Standard Deviation|Mean
31488|NCT01580072|Secondary|COPD Assessment Test CAT (Carinthia)|No data available|12 months||||||
31489|NCT01580072|Secondary|All Cause Mortality|deceased patients in respect to participating patients, by obituary column|12 months||||||
31490|NCT01580072|Secondary|Number of Consultations of Emergency Doctor||12 months|||consultations ED||Standard Deviation|Mean
31491|NCT01580072|Secondary|Number of Specialist Visits||12 months|||visits specialists||Standard Deviation|Mean
31492|NCT01580072|Secondary|Number of Primary Care Visits|Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement.|12 months|||visits GP||Standard Deviation|Mean
31495|NCT01580072|Primary|Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status.|Baseline analyses and analyses after 12 months were conducted. Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported. A high score defines a more favorable health state, items are scored on a 0 to 100 range. Scale scores represent the average for all items in the scale that the respondent answered.|12 months|||units on a scale||Standard Deviation|Mean
31496|NCT01580020|Secondary|Time to the First Retreatment of Both Treatment Arms|Time to the first retreatment|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.||Days||95% Confidence Interval|Median
31497|NCT01580020|Secondary|Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Score on a scale||Standard Deviation|Mean
31498|NCT01580020|Secondary|Change in SF-36 Summary Scores|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Score on a scale||Standard Deviation|Mean
31499|NCT01580020|Secondary|Change in Mean Visual Function Questionnaire (VFQ-25)|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, 12 months|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Scores on a scale||Standard Deviation|Mean
31500|NCT01580020|Secondary|Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12|FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,|Baseline, Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||um||Standard Deviation|Mean
31501|NCT01580020|Secondary|Change in Central Subfield Thickness (CSRT) From Baseline to Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline , Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||um||Standard Deviation|Mean
31502|NCT01580020|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline|12 month|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Percentage of participants|||Number
31503|NCT01580020|Secondary|Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement|Baseline, 6 months and 12 months|FAS consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.||Letters read correctly||Standard Deviation|Mean
31545|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31504|NCT01580020|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants who experienced Adverse events, serious AE and death|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.||Participants|||Number
31505|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of Participants|||Number
31506|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of Participants|||Number
31507|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
31508|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
31509|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
31510|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
31511|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
31512|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
31513|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).||Percentage of participants|||Number
31514|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1- 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60)||Percentage of Participants|||Number
31515|NCT01579916|Primary|Percentage of Participants Reporting Fever Within 7 Days Post Vaccination|A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza vaccine = 241; placebo = 60).||Percentage of Participants|||Number
31516|NCT01579747|Secondary|Number of Redirections|Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.|6 months|||passes||Inter-Quartile Range|Median
31517|NCT01579747|Primary|Procedural Time|Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique|less than 30 minutes|||seconds||Standard Deviation|Mean
31518|NCT01579669|Secondary|Change in Patient Healthcare Self-Efficacy|Autistic participants completed a 21-item healthcare self-efficacy scale before and 1 month after use of the toolkit. The scale was created de novo for this study, based on our prior qualitative work. Items addressed aspects related to healthcare navigation (e.g. “How confident are you that you can make an appointment with your healthcare provider when needed?”), successful interactions with providers, (e.g. “How confident are you that you can describe your symptoms or healthcare concerns to your provider?”), and self-management (e.g. “How confident are you that you can take medications the way you are supposed to take them?”). Response options used a 4-point Likert scale with anchors of “0 - Not at all confident” to “3 - Totally confident”. We scored self-efficacy by adding responses from the 21 items, resulting in a possible range of 0 to 63, with higher scores corresponding to higher self-efficacy. Cronbach's alpha was 0.92.|Before and 1 month after use of toolkit|Participants completing pre- and post-intervention survey themselves (not via a supporter), who had complete data on the self-efficacy scales on both surveys.||units on a scale||Standard Error|Mean
31519|NCT01579669|Secondary|Change in Patient's Perceived Barriers to Healthcare|Autistic participants were presented with a list of 16 barriers to healthcare and asked which ones keep them from obtaining good care. We compared the total number of barriers endorsed by participants in the pre- and post-intervention surveys. The proxy version of the survey included a few modified items to differentiate between barriers faced by the autistic individuals and those faced by the supporter. Due to differences in the wording, we could not combine results from those who participated directly with those who participated by proxy. Only data from autistic adults who participated directly is shown.|Before and 1 month after use of toolkit|Participants completing the pre and post-test themselves (not via a supporter).||number of barriers||Standard Error|Mean
31520|NCT01579669|Secondary|Change in Patient Satisfaction With Healthcare|Patients completed an 8-item instrument assessing satisfaction with their primary healthcare experiences. The scale was previously adapted from the 2007 Health Information National Trends Survey (HINTS). In the pre-intervention survey autistic participants were asked to think about their last visit with their primary care provider. We did not assess patient-provider communication for those who were participating via a proxy as we did not feel that a proxy could adequately rate how satisfied the patient was with communication. Only autistic participants who said they had seen their PCP since using the healthcare toolkit were re-asked these items in the post-intervention survey. Responses used a 5-point Likert scale with anchors of “1 – Strongly Disagree” to “5 – Strongly Agree”. We analyzed items by summing the responses into a composite score (range 8-40; higher scores indicate higher satisfaction). Cronbach's alpha = 0.92.|before and 1 month after use of toolkit|Autistic adults who participated directly (not via a proxy) and who saw their provider in the 1 month between when they participated in the baseline assessment and they completed the post-intervention survey.||units on a scale||Standard Error|Mean
31521|NCT01579669|Secondary|Patient Use of Toolkit Components|We collected data on whether or not participants completed the Autism Healthcare Accommodations Tool (AHAT) survey and whether or not they allowed the research team to send a copy of the report to their primary care provider.|1 month after use of toolkit|||percentage of participants|||Number
31522|NCT01579669|Secondary|Provider Satisfaction|Providers participated in a brief survey to assess satisfaction with the toolkit. Items addressed overall satisfaction and if they would or would not use the tools with other patients.|1-2 months after patient uses toolkit|Participants' primary care providers. Primary care providers were included in the study to assess their impression of the toolkit, but all other outcomes (e.g. change in barriers, self-efficacy, or satisfaction with healthcare) only apply to the autistic participants, not their primary care providers.||percentage of PCPs|||Number
31523|NCT01579669|Primary|Patient Satisfaction|Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.|1 month after use of toolkit|||percentage of participants|||Number
31524|NCT01579578|Secondary|The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR. (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)|Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full analysis set||Participants|||Number
31525|NCT01579578|Secondary|Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).|Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012|||months|Participants|Inter-Quartile Range|Median
31526|NCT01579578|Primary|Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone||Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full Analysis Set||percentage change|Participants|Standard Error|Least Squares Mean
31527|NCT01579565|Secondary|Systemic Pharmacokinetics (PK) of OMS302|Systemic pharmacokinetics (PK) of phenylephrine (PE) and ketorolac (KE) were performed in a subset of subjects. Descriptive summary statistics for area-under-the-serum-concentration-time curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), and terminal phase half-life (t1/2) were to be generated if measured plasma concentrations were adequate for analysis. Descriptive statistics for pharmacokinetics were not performed as detected concentrations were low and insufficient for analysis.|24 hours|Subset of subjects randomized to OMS302 treatment.||participants|||Number
31528|NCT01579565|Secondary|Postoperative Best Corrected Visual Acuity (BVCA) on Day 1|Best Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. The reason for missing scores (e.g., subject could not read enough letters to obtain a score or refraction was not completed) was also summarized. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day postoperatively|Subjects with score at time point.||Log score||Standard Deviation|Mean
31546|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31547|NCT01579474|Secondary|Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8|Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8|up to 8 weeks|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||percentage of participants|||Number
31529|NCT01579565|Secondary|Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day postoperatively|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
31530|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 1 Day Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.|One day postoperatively|Subjects with scores at time point.||participants|||Number
31531|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 6 Hours Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.|Six hours postoperatively|Subjects with scores at time point.||participants|||Number
31532|NCT01579565|Secondary|Ocular Pain VAS Score on Day 1|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time point.|One day postoperatively|Subjects with score at time point.||units on a scale||Standard Deviation|Mean
31533|NCT01579565|Secondary|Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively|The number of subjects who report ocular pain-free status (VAS equal to 0) at all time points during 12 hours postoperatively summarized by treatment arm. Subjects with missing VAS scores during the 12 hours postoperatively were considered as not being pain-free.|12 hours postoperatively|Subjects with scores at time points.||participants|||Number
31534|NCT01579565|Secondary|Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively|The number of subjects with moderate -to-severe pain (VAS￼ greater than or equal to 40) at any time point during 12 hours postoperatively summarized by treatment arm.|12 hours postoperatively|Subjects with VAS scores at time points.||participants|||Number
31535|NCT01579565|Secondary|Pupil Diameter Less Than 6 mm Anytime During Surgery|The number of subjects with pupil diameter less than 6 mm at any time during surgery summarized by treatment arm.|Intraoperative|Subjects with interpretable video images obtained during ILR procedure.||participants|||Number
31536|NCT01579565|Secondary|Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up|The number of subjects with pupil diameter of at least 6 mm at the completion of cortical clean up summarized by treatment arm. The last pupil diameter was used if not available at completion of cortical clean up.|at time of cortical clean-up (i.e., end of surgical procedure)|Subjects with interpretable video images obtained during ILR procedure.||participants|||Number
31537|NCT01579565|Primary|Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively|The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours postoperatively|Subjects with scores at time points.||units on a scale||Standard Deviation|Mean
31538|NCT01579565|Primary|Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery|The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.|From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.||mm||Standard Deviation|Mean
31539|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31540|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31541|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31542|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31543|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||participants|||Number
31548|NCT01579474|Secondary|Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)|Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||percentage of participants||95% Confidence Interval|Number
31549|NCT01579474|Secondary|Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)|Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)||percentage of participants||95% Confidence Interval|Number
31550|NCT01579474|Primary|Number of Patients With Investigator Defined Drug-related Adverse Events|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|Up to 52 weeks|Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication.||participants|||Number
31551|NCT01579305|Primary|Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer’s Assessment|The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).|3 months|Per-protocol population (all subjects who are randomized, received at least 1 study treatment, and have no protocol deviations that affect the primary effectiveness endpoint)||Percentage of subjects||95% Confidence Interval|Number
31552|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 5|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
31553|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
31554|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness.|Baseline, Day 1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
31555|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 1|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 1-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.||Percentage of responders|Participants||Number
31556|NCT01579045|Secondary|Monocular Visual Acuity in Recumbent Position|Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).|up to 60 minutes in recumbent position|Analysis is on those who were enrolled, randomized, and whom completed the study.||units on a scale (LogMAR)||95% Confidence Interval|Least Squares Mean
31557|NCT01579045|Primary|Lens Orientation in Recumbent Position|rotation from zero position also described as absolute value of the rotation.|up to 60 minutes in recumbent position|Subjects analyzed were those enrolled, randomized, and whom completed the study.||degrees||95% Confidence Interval|Least Squares Mean
31558|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation||5-6 months|FAS population||percentage of participants||95% Confidence Interval|Number
32909|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole|Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.||pg/mL||Standard Deviation|Mean
31559|NCT01579006|Secondary|Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
31560|NCT01579006|Secondary|Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6|The FACIT Measurement System was a collection of health-related quality of life questionnaires targeted to the management of chronic illness and included questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. The FACIT Fatigue Scale was a 13-item tool that measured an individual’s level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a five-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score of FACIT ranged from 0 to 160. An increase of 4 points in the FACIT-Fatigue score was considered clinically meaningful. Change from Administration 1 was reported for individual administration schedules. TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|Administration 1 (Baseline), 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||Score on a scale||Standard Deviation|Mean
31561|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain). A decrease of 10 points was considered clinically meaningful.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
31562|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
31563|NCT01579006|Secondary|Change From Baseline in HAQ-DI at Month 6|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from “no difficulty” to “unable to do”, corresponding to scores from 0 to 3. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity. A score of <0.5 represented clinical remission. A participant achieved a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of >=0.22.|Baseline, 6 months|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
31564|NCT01579006|Secondary|Change From Baseline in PGH of Disease Activity at Month 6|"The PGH of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
31565|NCT01579006|Secondary|Change From Baseline in PhGH at Month 6|"The PhGH was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm||Standard Deviation|Mean
31566|NCT01579006|Secondary|Change From Baseline in ESR at Month 6|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. ESR was measured in mm/hr. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mm/hr||Standard Deviation|Mean
31567|NCT01579006|Secondary|Change From Baseline in CRP at Month 6|The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. The serum concentration of CRP was measured in mg/dL. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mg/dL||Standard Deviation|Mean
31568|NCT01579006|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
31578|NCT01579006|Secondary|Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician|A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
31569|NCT01579006|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
31570|NCT01579006|Secondary|Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants|||Number
31571|NCT01579006|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of <=10.0 represented low disease activity, a score of <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
31572|NCT01579006|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of <=11.0 represents low disease activity, a score of <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
31573|NCT01579006|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB >=-0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
31574|NCT01579006|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [mm/hr]), and Patient’s Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Score on a scale||Standard Deviation|Mean
31575|NCT01579006|Secondary|Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6|The number of swollen joints was recorded on the joint assessment form, with no swelling = 0, and swelling =1, for 66 joints, giving a total possible SJC score of 0 to 66.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||Swollen Joint Count||Standard Deviation|Mean
31576|NCT01579006|Secondary|Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6|The number of tender joints was recorded on the joint assessment form, with no tenderness = 0, and tenderness = 1, for 68 joints, giving a total possible TJC score of 0 to 68.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants with valid data to calculate TJC at the end of study (6 months).||Tender Joint Count||Standard Deviation|Mean
31577|NCT01579006|Secondary|Percentage of Participants on TCZ Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had TCZ as monotherapy were reported.|Up to 6 months|FAS population. Here, “n”= participants who were evaluable for each category.||percentage of participants||95% Confidence Interval|Number
31580|NCT01579006|Secondary|Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population.||percentage of participants||95% Confidence Interval|Number
31581|NCT01579006|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. The mean dosing interval between different TCZ administrations (Adm) by participants within 6 months observational period was presented.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||days||Standard Deviation|Mean
31582|NCT01579006|Secondary|Mean Number of Dose Modifications at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||dose modification||Standard Deviation|Mean
31583|NCT01579006|Secondary|Mean Dose at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
31584|NCT01579006|Secondary|Percentage of Participants With Reasons for Dose Modification|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had dose modifications were reported.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
31585|NCT01579006|Secondary|Percentage of Participants With Dose Modifications|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||percentage of participants||95% Confidence Interval|Number
31586|NCT01579006|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined by physician discretion. Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||percentage of participants|||Number
31587|NCT01579006|Secondary|Duration of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.||years||Standard Deviation|Mean
31588|NCT01579006|Secondary|Percentage of Participants With Type of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). Same participants may be counted in more than one previous biologic RA treatment category.|Up to 6 months|FAS population.||percentage of participants|||Number
31589|NCT01579006|Secondary|Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study|"Biological RA treatment exposure was evaluated for all participants. Prior biological RA treatment included participants who were treated with biological RA treatment 8 weeks before being included in the study. Percentage of participants who did not receive any biological RA treatment and percentage of participants who received one or more biologic RA treatments were reported."|Prior to study start (8 weeks)|FAS population.||percentage of participants|||Number
31590|NCT01579006|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|Up to 6 months|FAS population.||percentage of participants||95% Confidence Interval|Number
31591|NCT01579006|Secondary|Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment included participants, who were treated with DMARDs 8 weeks and according to physician's discretion before being included in the study. DMARDs treatment at baseline included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ. Only those participants who received DMARDs prior to start of study and at Baseline up to 6 months were reported."|Prior to study start (8 weeks) and Baseline up to 6 months|FAS population.||percentage of participants|||Number
31592|NCT01579006|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations included fibromyalgia, osteoporosis, sjogren’s syndrome, anemia, rheumatoid nodules, pulmonary fibrosis, vasculitis, peripheral neuropathy or mononeuropathy, scleritis, episcleritis, hypertension, hyperlipidemia, low high-density lipoproteins, diabetes type 1 and type 2, metabolic syndrome, carotid artery disease, transient ischemic attacks, embolic stroke, atherothrombotic stroke, atrial fibrillation, heart failure New York Heart Association (NYHA) Class l/ll, coronary heart disease(angina pectoris/myocardial), aortic aneurism, peripheral arterial occlusive disease, percutaneous coronary interventions, coronary artery bypass, carotid endarterectomy and peripheral arterial bypass.|Baseline|FAS population.||percentage of participants|||Number
31593|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population||percentage of participants||95% Confidence Interval|Number
31594|NCT01578993|Primary|Rate of PICC Line Occlusions|The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.|Insertion to Removal / maximum 3 months|||percentage of enrolled subjects|||Number
31595|NCT01578980|Secondary|Frequency of Unplanned System Resets or Restarts|"Frequency of unplanned system resets or restarts~Secondary endpoints include the estimation of the failure rates of system components, frequency analysis of lost or inaccurate CGM records, and percent time of active CTR. The failure/missing data records will be compared to failure/missing data records from our past in-clinic studies."|42 hours|The three pilot subjects (one for each country) were not included in the analysis.||events per 24 hours|||Number
31596|NCT01578980|Primary|Percent Time of Active CTR|The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation for the entire arm.|42 hours|The three pilot subjects (one for each country) were not included in the analysis.||percentage of time of active CTR|||Number
31597|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
31598|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
31599|NCT01578850|Secondary|Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2|Participants were asked to answer the question “In general how would you rate your health over the last 2-3 weeks?” by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
31600|NCT01578850|Secondary|Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1|Participants were asked to answer the question “In general how would you rate your health over the last 2 3 weeks?” by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
31601|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||minutes||Standard Deviation|Mean
31602|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||minutes||Standard Deviation|Mean
31603|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 2|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
31604|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 1|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
31605|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2|The investigator estimated the subject’s overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
31606|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1|The investigator estimated the subject’s overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
31607|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
31608|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Units on a scale||Standard Deviation|Mean
31609|NCT01578850|Secondary|Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR’s definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
31610|NCT01578850|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR’s definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||percentage of participants|||Number
31611|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 2|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
31612|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 1.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
31613|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization||Percentage of participants|||Number
31614|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
31615|NCT01578850|Secondary|Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
31616|NCT01578850|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
31617|NCT01578850|Secondary|Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria|Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
31618|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||units on a scale||Standard Deviation|Mean
31619|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||units on a scale||Standard Deviation|Mean
31620|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
31621|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1|Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
31622|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
31623|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).||Percentage of participants|||Number
31624|NCT01578850|Secondary|Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)|Proportion of participants who remained in Remission (DAS28-ESR <2.6) at Week 52.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||Percentage of participants|||Number
31625|NCT01578850|Primary|Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.|Proportion of participants who remained in LDA DAS28-ESR <3.2 at Week 52 is presented below.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.||percentage of participants|||Number
31626|NCT01578785|Secondary|Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume|Brain atrophy was defined by the percent brain volume change from baseline to Month 12|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
31627|NCT01578785|Secondary|The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
31628|NCT01578785|Secondary|The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
31629|NCT01578785|Primary|The Annualized Relapse Rate During the Placebo Controlled Period|The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.|||||
31630|NCT01578772|Primary|6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)|||percentage of maximum relative FMD||Inter-Quartile Range|Median
31631|NCT01578772|Primary|6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)|||mm||Inter-Quartile Range|Median
31632|NCT01578707|Secondary|Hematological Improvements||2 years||||||
31633|NCT01578707|Secondary|OS (Overall Survival)||OS analysis was conducted at the time of the interim PFS analysis, which was about 18 months after the first subject was enrolled.|||months||95% Confidence Interval|Median
31634|NCT01578707|Primary|PFS (Progression Free Survival)|"The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS).~Progressive disease according to 2008 IWCLL guidelines was defined as:~Group A~Lymphadenopathy, increase ≥50%~Hepatomegaly, increase ≥50%~Splenomegaly, increase ≥50%~Blood lymphocytes, increase ≥ 50% over baseline~Group B~Platelets counts, decrease of ≥ 50% from baseline secondary to CLL~Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL"|Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.|||months||95% Confidence Interval|Median
31635|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||score on scale||Standard Deviation|Mean
31636|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 6|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||score on scale||Standard Deviation|Mean
31647|NCT01577758|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood was collected and sent to a laboratory to determine the immunogenicity, whether binding antibodies to MLN0264 were present (ATA development).|Day 1 of every 21 days cycle and at End of study (EOS) approximately 9 months|||participants|||Number
31658|NCT01577628|Secondary|Time of Onset of Food Allergy in Infants|Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
41841|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|5 years||||||
31637|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 1|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||score on scale||Standard Deviation|Mean
31638|NCT01578330|Primary|Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|Baseline and month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit||Scores on a scale||Standard Deviation|Mean
31639|NCT01578187|Primary|Percentage of Participants Performing Critical/Non-critical Errors|"Study staff will record the number of errors according to the following:~Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence~Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event."|1-2 hours|Subjects who were not self-excluders in the label comprehension phase and consented to continue to the usability phase (product use).||percentage of participants with errors|||Number
31640|NCT01578187|Primary|Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders)|"Label comprehension will be based on responses to a questionnaire. Questions will be based on a tiered system by level of importance in responding correctly according to the following:~Questions regarding safe use of the system.~Questions regarding correct use of the system(not related to safety).~In order to demonstrate how well the label instruction, as a whole, was understood by all subjects, the proportion of subjects who correctly understood the label as a whole was calculated by classifying each subject as either a “responder or non-responder” based on the following criteria regarding all questions:~A subject was considered a responder if he/she correctly answered 11/12 questions related to safety AND 5/6 low category questions not related to safety.~The study was considered a success if the response rate (i.e., the proportion of subjects correctly understanding the label based on the responder criteria) was at least 90%."|1 hour|Sample size was discussed with the FDA during a pre-IDE teleconference||percentage of participants|||Number
31641|NCT01578044|Primary|Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban|The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.|3 and 6 months|||days|||Number
31642|NCT01577966|Primary|Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine|To determine the ability of sulfasalazine to alter glioma glutamate levels. These levels will be measured by Magnetic Resonance Spectroscopy (MRS). The percent change is noted per subject. The measure is a % decrease of glioma glutamate levels|up to 2 years post baseline|||percentage of change|||Number
31643|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE|Area under the plasma drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameter AUC0-21 days.||day*ng/mL||Full Range|Geometric Mean
31644|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246|Area under the drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.||day*μg/mL||Full Range|Geometric Mean
31645|NCT01577758|Primary|Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.||ng/mL||Full Range|Geometric Mean
31646|NCT01577758|Primary|Cmax: Maximum Observed Serum Concentration for MLN0264|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.||μg/mL||Full Range|Geometric Mean
31648|NCT01577758|Secondary|Best Overall Response|"The percentage of participants in each best overall response category, was determined using the Modified Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response: Disappearance of all target lesions and all non-target lesions and normalization of tumor marker level.~Partial Response: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the start or the appearance of one or more new lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits."|At the completion of every second cycle up to 12 cycles (approximately 9 months). Each cycle is a 21 days cycle|Response Evaluable Population is defined as patients with measureable disease who receive any amount of MLN0264 and have at least 1 post-Baseline response assessment.||percentage of participants|||Number
31649|NCT01577758|Primary|Maximum Tolerated Dose (MTD) of MLN0264|MTD of MLN0264 was determined. Decisions regarding dose escalation were made based on any DLT that occurred during the first cycle of treatment.|Every 3 weeks until MTD is established, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.||mg/kg|||Number
31650|NCT01577758|Primary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.~A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|Safety Analysis Set included all participants who received at least one dose of study drug.||participants|||Number
31651|NCT01577758|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy.~Grade 4 neutropenia (Absolute Neutrophil Count < 500 cells/mm^3).~Grade 3 or greater neutropenia with fever and/or infection.~Grade 4 thrombocytopenia (platelets < 25,000/mm^3).~Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time.~Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis.~Grade 3 or greater diarrhea that occurs despite supportive care.~Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia.~Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery.~Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.||participants|||Number
31652|NCT01577732|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30).|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
31653|NCT01577732|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
31654|NCT01577732|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
31655|NCT01577732|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.||Subjects|||Number
31656|NCT01577628|Secondary|Time of Onset of Atopic Dermatitis|Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31657|NCT01577628|Secondary|Adverse Events (AEs) Collection|Adverse events (Skin AEs, asthma, food allergies, allergic rhinitis and any AE related to Lipikar Syndet, Lipikar Balm AP (group 1) or any other moisturizer application (group 2) will be collected.|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31659|NCT01577628|Secondary|Time of Onset of Asthma in Infants|Time of onset of asthma in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31660|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop a Food Allergy|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31661|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Asthma|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31662|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Atopic Dermatitis|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31663|NCT01577628|Secondary|Proportion of Infants Who Develop a Food Allergy|Proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31664|NCT01577628|Secondary|Proportion of Infants Who Develop Asthma|Proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31665|NCT01577628|Primary|Proportion of Infants Who Develop Atopic Dermatitis|Proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure|||||
31666|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31667|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31668|NCT01577381|Secondary|Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)|Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31669|NCT01577381|Secondary|Plasma Population PK Parameters|Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.|Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31670|NCT01577381|Secondary|Accumulation Ratio (Rac) for AUCt||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31671|NCT01577381|Secondary|Clearance at Steady State (CLss)|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)|Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31672|NCT01577381|Secondary|Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31673|NCT01577381|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31674|NCT01577381|Secondary|Maximum Observed Plasma Concentration (Cmax)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31675|NCT01577381|Secondary|Number of Participants With Treatment-Related TEAEs|An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least one dose of study product.||Participants|||Number
31676|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least 1 dose of study drug.||Participants|||Number
31677|NCT01577381|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|The number of participants with positive ADA was to be summarized for each treatment arm.|Day 57 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31678|NCT01577381|Secondary|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.|Days 28, 57, 85, 113 and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31679|NCT01577381|Secondary|Number of Participants With Abnormal Change From Baseline in Vital Signs|Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.|Screening, Days 28, 57, 85, 113, 141, and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31680|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Laboratory Abnormalities|Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.|Day 85 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31681|NCT01577381|Secondary|Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31682|NCT01577381|Secondary|Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31683|NCT01577381|Secondary|Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31684|NCT01577381|Secondary|Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31715|NCT01576367|Secondary|Change From Baseline (Core Study Baseline) in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations|CRP and SAA were used as serologic inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Week 0, 80, 104, 128 and 152, last assessment|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study||(mg/L)||Standard Deviation|Mean
31685|NCT01577381|Secondary|Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31686|NCT01577381|Secondary|Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31687|NCT01577381|Secondary|Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31688|NCT01577381|Secondary|Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31689|NCT01577381|Secondary|Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31690|NCT01577381|Secondary|Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31691|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31692|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31693|NCT01577381|Secondary|Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31694|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
51746|NCT01300286|Secondary|Platelet Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||mL||Inter-Quartile Range|Median
31695|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31696|NCT01577381|Secondary|Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31697|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)|GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).|Baseline and Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31698|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309|GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).|Baseline and Day 309|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).|||||
31699|NCT01577186|Other Pre-specified|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
31700|NCT01577186|Other Pre-specified|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
31701|NCT01577186|Primary|Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
31702|NCT01577186|Secondary|Social Functioning Scale (SFS) Score|The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
31713|NCT01576367|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|pre-vaccine dose, Day 28 post-vaccine|"Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study. Out of 20 unique patient-vaccination cases, 17 cases were assessable for a vaccination response whereas for the remaining 3 cases no pre-dose antibody titer was available,"||vaccination cases|Participants||Number
32143|NCT01568008|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
31703|NCT01577186|Primary|Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.|End of study (Up to Week 12)|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
31704|NCT01577160|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
31705|NCT01577160|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
31706|NCT01577160|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.||participants|||Number
31707|NCT01577160|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||units on a scale||Standard Deviation|Mean
31708|NCT01577160|Primary|Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as “1: very much improved” or “2: much improved” on the CGI-I scale at Week 12.|Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
31709|NCT01576952|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.||participants|||Number
31710|NCT01576809|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour|||participants|||Number
31711|NCT01576809|Secondary|Subject Acceptability of the Syrup|"In response to the question How did you like the warming sensation you have experienced for this product?, the number of patients answering Like extremely or Like very much or Like moderately or Like slightly~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour|||participants|||Number
31712|NCT01576809|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation|1 minutes|||mm||Standard Deviation|Mean
31714|NCT01576367|Secondary|Frequency Counts of Physician’s Global Assessment of Autoinflammatory Disease and Skin Disease|Participants were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe|minimum of 6 months and maximum of 24 months|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study||Percentage of participants|||Number
31716|NCT01576367|Secondary|Immunogenicity of Canakinumab (ACZ885). Number of Participants With Anti-canakinumab Antibodies|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|minimum of 6 months and maximum of 24 months|Extension Safety set consisted of all patients from the core study who received at least one dose of study drug in the extension study and had at least one post-treatment safety assessment. Of note, the statement that a patient had no AE also constituted a safety assessment.||Participants|||Number
31717|NCT01576367|Primary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Serological Inflammation Markers.|Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal. Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe.|Week /80, 104, 128, and 152 (A minimum of 6 months and maximum of 24 months)|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study||Percentage of participants|||Number
31718|NCT01576159|Secondary|Physiological (Maximum Oxygen Consumption) Changes of Participants||Baseline and 12 weeks|||ml/kg/min||Standard Deviation|Mean
31719|NCT01576159|Secondary|Physical (Body Mass Index) Changes of Participants||Baseline and 12 weeks|||kg/m^2||Standard Deviation|Mean
31720|NCT01576159|Primary|Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises||Baseline and 12 weeks|||U/l||Standard Deviation|Mean
31721|NCT01576120|Primary|• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients|"effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment~The duration of the procedure in this study is 1 day of colon preparation and~1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted."|The end points and outcomes measures will be evaluated within 4 months from end of enrollment|||percentage of adequate cleansing||95% Confidence Interval|Number
31722|NCT01576055|Secondary|Number of Participants With Device Success|Successful delivery of stent to the intended site and successful stent deployment.|Immediately following initial device implant (usually within a few minutes to an hour).|Per Protocol Population||participants|||Number
31723|NCT01576055|Secondary|Number of Participants With Procedural Success|Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.|Within 48 hours of initial device implant|Per Protocol Population||participants|||Number
31724|NCT01576055|Primary|Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months|Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.|12 Months|Per Protocol Population (Participants Available for 12-Month Follow-Up)||participants|||Number
31725|NCT01576055|Primary|Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days|Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).|30 Days|Per Protocol Population (Participants Available for 30-Day Follow-Up)||participants|||Number
31726|NCT01576042|Secondary|Number of Participants Received Treatment Assigned|Records participants who received study randomized treatment during the study|6 months|||participants|||Number
31727|NCT01576042|Secondary|Time to First Recurrent ICD Therapy for VT|Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.|Baseline, 6 months|||Days||Standard Deviation|Mean
31728|NCT01576042|Secondary|Number of Participants Switched to Other Arm|Records participants who received study treatment as randomized and later switched to other treatment arm during the study|6 months|||participants|||Number
31729|NCT01576042|Secondary|Number of Participants Remained on Randomized Treatment Assignment|Records participants who only received study treatment as randomized during the entire study|6 month|||participants|||Number
31730|NCT01576042|Secondary|Cardiovascular Hospitalizations|Records participants hospitalized for VT during the study|Baseline, 6 months|||participants|||Number
31731|NCT01576042|Secondary|Number of Participants Had at Least One of the Efficacy Outcome Measurement|Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)|6 Months|||participants|||Number
31732|NCT01576042|Secondary|Number of Participants Completed Month 6 Follow-Up|Records participants who completed Month 6 Follow-Up Visit|6 Months|||participants|||Number
31733|NCT01576042|Primary|Number of Participants Completed Month 3 Follow-Up|Records participants who completed Month 3 Follow-Up Visit|3 months|||participants|||Number
31734|NCT01575899|Secondary|Eradication Rate of Participants Living in Rural Area.|Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.|4 weeks after complete use of drug for treatment|Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan.||percentage of eradicated participants|||Number
31735|NCT01575899|Other Pre-specified|Re-eradication Rate|Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.|4 weeks after complete use of drug for treatment|This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.||percentage of successful re-eradication|||Number
32069|NCT01568905|Secondary|Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes|Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.|Baseline (Day 1) Compared to Second Visit (Week 1)|||units on a scale||Standard Error|Mean
31736|NCT01575899|Primary|Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)|A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.|4 weeks after complete use of drug for treatment|Intent to treat analysis of eradication (negative result of follow up method) measured 4 weeks after complete the treatment, for participants never received anti-H. pylori treatment before.||percentage of eradicated participants|||Number
31737|NCT01575769|Secondary|Absolute C-Reactive Protein Levels||Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||milligrams per Liter||Standard Deviation|Mean
31738|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Walking component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31739|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Reach component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31740|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Hygiene component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31741|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Grip component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31742|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Eating component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31743|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Dressing and Grooming component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31744|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Arising component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31745|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Activity component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31746|NCT01575769|Secondary|Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A minimally important improvement was defined as at least a 0.13 improvement in CHAQ-DI score from baseline.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
32144|NCT01568008|Secondary|Physician Reported Reasons for Treatment Discontinuation|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
31747|NCT01575769|Secondary|Change From Baseline in Childhood Health Assessment – Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||units on a scale||Standard Deviation|Mean
31748|NCT01575769|Secondary|Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up||Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||millimeters per hour (mm/hour)||Standard Deviation|Mean
31749|NCT01575769|Secondary|Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The participant or parent/guardian, as appropriate, provides a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||mm||Standard Deviation|Mean
31750|NCT01575769|Secondary|Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The physician provides a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||mm||Standard Deviation|Mean
31751|NCT01575769|Secondary|Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The maximum number of joints with limitation of movement is 67 and these were defined as those with 'limitation of motion'.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||Joints||Standard Deviation|Mean
31752|NCT01575769|Secondary|Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|Joint with active arthritis was defined as a joint with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.||Joints||Standard Deviation|Mean
31753|NCT01575769|Secondary|Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up|Clinical remission: inactive disease for minimum of 6 continuous months while on medication (Level 1); off oral corticosteroid medications but still on tocilizumab (Level 2); off both methotrexate and oral corticosteroids but still on tocilizumab (Level 3); or off all anti-arthritis medications-oral corticosteroids, methotrexate, non-steroidal anti-inflammatory drugs but still on tocilizumab (Level 4). Inactive disease: No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to sJIA; Normal ESR (<20 mm/hour); PGA of disease activity indicated no disease activity (score ≤10 mm on a 100 mm VAS where 0 [inactive arthritis] and 100 [very active arthritis]). Overall percentage of participants with clinical remission (any level) are reported.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
31754|NCT01575769|Secondary|Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up|"Criteria for Inactive Disease:~1) No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both), 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal ESR (less than [<] 20 millimeters per hour [mm/hour]), and 4) PGA of disease activity using VAS indicated no disease activity (where no disease activity is considered to be a score less than or equal to [≤]10 mm on a 100 mm VAS where left end of line 0 [inactive arthritis] to right end of line 100 [very active arthritis])."|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
31755|NCT01575769|Secondary|Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up|JIA ACR90 response was defined as 3 of any 6 core outcome variables improved by at least 90% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
31851|NCT01573260|Secondary|Apathy Evaluation Scale (AES)|This is a 14-item patient-rated scale which measures cognitive, emotional, and behavioural symptoms of apathy. All items are rated on a 0 to 3 Likert Scale. The original 18-item scale has been shortened by four items, and wording simplified and it was reported to have excellent psychometric properties in PD (internal consistency reliability = 0.76, test-retest 1 week r = 0.90). Total score is ranging from 0 (best possible outcome) to 42 (worst possible symptoms).|26 weeks|||score||Standard Deviation|Mean
31756|NCT01575769|Secondary|Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up|JIA ACR70 response was defined as 3 of any 6 core outcome variables improved by at least 70% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
31757|NCT01575769|Secondary|Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up|JIA ACR50 response was defined as 3 of any 6 core outcome variables improved by at least 50% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
31758|NCT01575769|Secondary|Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up|JIA ACR30 response was defined as 3 of any 6 core outcome variables improved by at least 30% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: Physician global assessment (PGA) of disease activity using Visual Analog Scale (VAS) from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); Patient/parent global assessment (PtGA) of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and Erythrocyte Sedimentation Rate (ESR).|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population||percentage of participants||95% Confidence Interval|Number
31759|NCT01575769|Primary|Percentage of Participants With Adverse Events (AEs)|AE: unfavorable and unintended sign, symptom, or disease associated with use of treatment, regardless of treatment relation. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from treatment were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Severe AE: AE that caused inability to work or perform normal daily activity. AEs of special interest: Serious infections (including opportunistic infections), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related AE, Malignant neoplasms, Anaphylaxis event, Demyelination-related events, Stroke, Spontaneous or serious bleeding, Serious/medically significant hepatic events. Any AE included serious and non-serious AE.|Baseline to 12 weeks after last actual study medication (up to 101 weeks)|Safety population||percentage of participants|||Number
31760|NCT01575756|Secondary|Clearance|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||mL/h/kg||Standard Deviation|Mean
31761|NCT01575756|Secondary|Terminal Half-life (t½)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||h||Standard Deviation|Mean
31762|NCT01575756|Secondary|Incremental in Vivo Recovery|Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin or Haemocomplettan® P or RiaSTAPTM (expressed as mg/kg dosed).|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||mg/dL/(mg/kg)||Standard Deviation|Mean
31763|NCT01575756|Secondary|Fibrinogen Activity Normalized Area Under the Curve Unstandardized|fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||h•kg•g/L/mg||Standard Deviation|Mean
31764|NCT01575756|Primary|Comparison of Maximum Clot Firmness Between Octafibrin and Haemocomplettan P/RiaSTAP at 1 hr Post Infusion|Thromboelastography (TEG) using rotational thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Rotational thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, only the fibrinogen content defined the maximum clot firmness.|Baseline to 1 hour post-treatment|Full analysis set: All randomised participants who received at least 1 infusion of study medication (Octafibrin and/or any part of an infusion of Haemocomplettan® P or RiaSTAPTM) and for whom any post-treatment data were available.||mm||95% Confidence Interval|Mean
31765|NCT01575756|Primary|Fibrinogen Activity Normalized Area Under the Curve Standardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.||g•h/L||Standard Deviation|Mean
31766|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient’s life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|baseline, week 12 (LOCF)|only 297 of the 377 subjects had the SDS total score at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
31767|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S depression assessment at Week 12 (LOCF)||units on a scale||Standard Deviation|Mean
31768|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7= Among the most extremely ill patients. A higher score is associated with greater illness severity|baseline, week 12 (LOCF)|Only 375 of the 377 subjects had the CGI-BP-S mania assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
31769|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)|Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S overall assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
31770|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)|Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression.|baseline ,Week 12 (LOCF)|Only 375 of the 377 subjects had the MADRS assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
31771|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)|Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline, 12 weeks (LOCF)|only 375 of the 377 subjects had the YMRD assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
32145|NCT01568008|Secondary|Physician Assessment of Treatment Tolerability Using a 4-Point Scale|The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
31772|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|baseline, 12 weeks (LOCF)|only 359 of the 377 subjects had the PANSS-P assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
31773|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|baseline, 12 weeks (LOCF)|only 351 of the 377 subjects had the QIDS-SR16 assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
31774|NCT01575561|Primary|Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events|Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation|12 weeks|||participants|||Number
31775|NCT01575522|Secondary|To Evaluate the Incidence of c-Met Positive Circulating Tumor Cells.||Baseline|||participants|||Number
31776|NCT01575522|Secondary|To Evaluate Phospho c-Met Expression in Archival Tumor Tissue.|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline|||participants|||Number
31777|NCT01575522|Secondary|To Evaluate c-Met Expression in Archival Tumor Tissue.|Assessment of ploidy status was done by visual screening of all tumor area; cells with maximum number of signals were recorded. MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline|||participants|||Number
31778|NCT01575522|Secondary|Overall Response Using RECIST v1.1|The 95% confidence intervals should be provided. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Conventional CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >/=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year|||percentage of participants||95% Confidence Interval|Number
31779|NCT01575522|Primary|PFS Status|Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from start of treatment to time of progression or death, assessed up to 6 months|||months||95% Confidence Interval|Median
31780|NCT01575197|Secondary|SAE Assessment|Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor.|Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation||||||
31781|NCT01575197|Secondary|Vaccine-type Rotavirus Shedding in Stool|Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer’s specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take.|Days 4 and 7 post each study vaccination||||||
31782|NCT01575197|Secondary|Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination|The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution.|Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)||||||
31783|NCT01575197|Secondary|IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 10 and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||titers||95% Confidence Interval|Geometric Mean
32146|NCT01568008|Secondary|Patient Assessment of Treatment Tolerability Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.||Participants|||Number
31784|NCT01575197|Secondary|IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 6, 10, and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||titers||95% Confidence Interval|Geometric Mean
31785|NCT01575197|Secondary|IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre- vaccination as measured by EIA.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||percentage of participants||95% Confidence Interval|Number
31786|NCT01575197|Primary|Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA).|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and oral polio vaccine (OPV) according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.||percentage of participants||95% Confidence Interval|Number
31787|NCT01575080|Secondary|Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements|Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.|1 hour|||participants|||Number
31788|NCT01575080|Secondary|Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot using the Contour TS BG Monitoring System. One subject was unable to obtain sufficient sample volume to test. Another subject's meter displayed||Number of BG Test Results|Participants||Number
31789|NCT01575080|Secondary|Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System||Number of BG Test Results|Participants||Number
31790|NCT01575080|Primary|Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System.||Number of BG Test Results|Participants||Number
31791|NCT01575054|Secondary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
31792|NCT01575054|Secondary|Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale|The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = “no pain” to 10 = “pain as bad as can be imagined”. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
31793|NCT01575054|Secondary|Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)|The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from −3 to 2 (−3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented.|Week 8|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
31794|NCT01575054|Secondary|Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale|The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline.|Baseline, 6 weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
31795|NCT01575054|Primary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received||Scores on a Scale||Standard Deviation|Least Squares Mean
31796|NCT01575028|Primary|Post-operative Pain Relief|Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.|12 hours post-operatively|Due to changes in surgical technique & protocols by the general surgeons, we were only able to recruit 3 study subjects and the study was terminated. No analysis was performed.|||||
31797|NCT01574703|Secondary|Incidence of MACE+ Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
31798|NCT01574703|Secondary|Incidence of MACE Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
31799|NCT01574703|Secondary|Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
31800|NCT01574703|Secondary|Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
31801|NCT01574703|Secondary|Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
31802|NCT01574703|Secondary|Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||percentage of participants|||Number
31803|NCT01574703|Secondary|Time to MACE Until the End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||Unitless||95% Confidence Interval|Number
31804|NCT01574703|Secondary|Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||Unitless||95% Confidence Interval|Number
32147|NCT01567943|Secondary|Psychiatric Symptomology|Brief Symptom Inventory; Positive and Negative Symptom Scale|throughout 7 months of study||||||
31805|NCT01574703|Primary|Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.||Unitless||95% Confidence Interval|Number
31806|NCT01574651|Secondary|"Symptoms Score Reported by the Patients Using Part I Symptoms of SGRO-C"|Part I of the SGRQ-C covers “symptoms” and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived “weight”. A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Score on a scale||Standard Deviation|Mean
31807|NCT01574651|Secondary|FEV1 30 Min After the Morning Dose at Baseline and Week 26|FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Liters||Standard Deviation|Mean
31808|NCT01574651|Secondary|Trough FEV1 at Baseline and Week 26|Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Liters||Standard Deviation|Mean
31809|NCT01574651|Secondary|Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period|The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Participants|||Number
31810|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Hospitalization|The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Percent of participants|||Number
31811|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks|The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Percent of participants|||Number
31812|NCT01574651|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.|Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Units on a scale||Standard Deviation|Mean
31813|NCT01574651|Secondary|St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George’s Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated||Score on a scale||Standard Deviation|Mean
31852|NCT01573260|Secondary|The Beck Depression Inventory (BDI)|"The BDI is a self-administered scale of 21 items (scored 0-3) which assesses depression symptoms. The Beck Inventory is one of the most commonly-used scales for depression in PD, and a recent consensus panel of the Movement Disorders Society concluded it was a scale of first choice for assessing depression in PD. Total score for the BDI is the sum of 21 items, ranging from 0 (best possible outcome) to 63 (worst possible symptoms)"|26 weeks|||score||Standard Deviation|Mean
31814|NCT01574651|Primary|St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated.||Score on a scale||Standard Deviation|Mean
31815|NCT01574612|Primary|Reporting of Adverse Events|treatment period is for 5 days and follow up visits at 7days and 21 days after first dose|day 1 to day 21|||participants|||Number
31816|NCT01574326|Secondary|Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus|Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.|Baseline, Week 28/Early Termination|FAS-DTP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after Week 2. Five participants (3 in sevelamer carbonate group and 2 in the placebo group) were excluded from the FAS-DTP due to no baseline phosphorus value or no phosphorus assessment after Week 2.||mg/dL||Standard Deviation|Mean
31817|NCT01574326|Primary|Treatment – Emergent Adverse Events (AEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.|Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)|Analysis was performed on safety set, which included all enrolled participants who received at least 1 dose of study drug. Participants were analyzed according to actual received treatment.||participants|||Number
31818|NCT01574326|Primary|Change From Baseline (Week 0) to Week 2 in Serum Phosphorus|Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.|Baseline, Week 2|FAS-FDP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline assessment after the first dose of study drug and on or before Week 2. Three participants (1 in sevelamer carbonate group and 2 in placebo group) were excluded from FAS-FDP due to no baseline phosphorus value at week 2.||mg/dL||Standard Deviation|Mean
31819|NCT01574248|Secondary|Systolic Blood Pressure|Average of blood pressure measurements from zero to forty-eight hours provided.|T0 to T48 hours|||mmHg||Standard Deviation|Mean
31820|NCT01574248|Secondary|Number of Participants Given Epinephrine||T0 to T48 hours|||Participants|||Count of Participants
31821|NCT01574248|Secondary|Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers||T0 to T48 hours|||Participants|||Count of Participants
31822|NCT01574248|Secondary|Number of Participants Given Steroids||T0 to T48 hours|||Participants|||Count of Participants
31823|NCT01574248|Secondary|Number of Participants With Requirement for Intubation||T0 to T48 hours|||Participants|||Count of Participants
31824|NCT01574248|Secondary|Number of Participants With Admission to Intensive Care Unit||T0 to T48 hours|||Participants|||Count of Participants
31825|NCT01574248|Primary|Time to Resolution of Angioedema|Time interval between initiation of treatment and when there is no symptom, by visual analog scale <1 cm. Data provided are for worst symptom.|48 hours|||hours||95% Confidence Interval|Median
31826|NCT01574183|Secondary|Marijuana Craving and Withdrawal|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly to all participants. Reported here is the mean MCQ purposefulness subscale score across 8 weeks.|8 weeks|||units on a scale||95% Confidence Interval|Mean
31827|NCT01574183|Secondary|Weekly Cannabis Use Sessions|Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption.|8 weeks|||weekly cannabis sessions||95% Confidence Interval|Mean
31828|NCT01574183|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|8 weeks|||percentage of UDS|Participants||Number
31829|NCT01574105|Secondary|Transfusion Events|Transfusion events to recorded will be the number of patients receiving units of red blood cells, units of platelets, units of plasma and units of cryoprecipitate.|Data collection begins with patient arrival in the operating room and ends with discharge from the ICU (normally less than 24hrs)|||Participants|||Number
31830|NCT01574105|Primary|Chest Tube Losses|Chest tube losses will be measured in millilitres upon arrival in the Intensive Care unit (ICU) after six hours in the ICU and total chest tube losses during the ICU stay. Chest tube losses are the amount of blood collected in a graduated chest tube collection reservoir from chest tubes placed in the patient's chest wound at the end of surgery.|Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)|||millilters||Standard Deviation|Mean
31932|NCT01572675|Secondary|Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (SBP and DBP)||mmHG||Standard Deviation|Mean
31831|NCT01574079|Secondary|Stroke Rehabilitation Assessment of Movement|The Stroke Rehabilitation Assessment of Movement (STREAM)is designed to measure mobility and motor ability after stroke. There are three subscales with 10 items each assessing the upper extremity, lower extremity, and basic mobility. Only the lower extremity and basic mobility items were used in this study. The lower extremity scores ranged from 0 - 18 with higher scores indicating a higher level of motor control. The basic mobility scores ranged from 0 - 30 with high numbers indicating a higher level of functional mobility.|measured at admission and discharge with estimated length of stay 14 days|||outcome score||Standard Deviation|Mean
31832|NCT01574079|Secondary|Timed Up and Go|The Timed Up and Go (TUG) is used to assess balance and gait, and to estimate fall risks in patients with deficits. The participant rises from a seated position in a chair, walks 3 meters, turns around, returns to the chair, and sits down. The test is measured in seconds, with a lower number indicating a higher level of independence and the least risk for falls.|Measured at admission and discharge with estimated length of stay 14 days|||seconds||Standard Deviation|Mean
31833|NCT01574079|Primary|Functional Independence Measure - Locomotor Score|The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence.|measured at admission and discharge from rehab estimated length of stay 14 days|Thirty-three participants enrolled in the study with 3 dropping out before completion. Two of these were due to medical issues, and one was discharged unexpectedly||outcome score||Standard Deviation|Mean
31834|NCT01573910|Primary|Microbiological Success Rate|Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.||percentage of participants|||Number
31835|NCT01573910|Primary|Clinical Cure Rate|Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.||percentage of participants|||Number
31836|NCT01573767|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 4-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
31837|NCT01573767|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
31838|NCT01573767|Secondary|Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
31839|NCT01573767|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
31943|NCT01572675|Primary|Indications for Which Arcoxia® and Celebrex® Were Prescribed|The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (indication)||Participants|||Number
31840|NCT01573767|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 4-week Treatment Period minus the value at Baseline. The Baseline value is defined as the value at Visit 3 (randomization). Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline; Week 1 up to Week 4|ITT population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
31841|NCT01573767|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline in trough FEV1 at the end of the 4-week Treatment Period was defined using the pre-dose FEV1 measurement taken at the Week 4 clinic visit. Change from Baseline was calculated as the Week 4 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
31842|NCT01573767|Primary|Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.|Baseline; Week 1 up to Week 4|ITT Population: participants randomized to treatment who received >=1 dose of study medication||Liters per minute (L/min)||Standard Error|Least Squares Mean
31843|NCT01573325|Secondary|Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL|Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.|2-3 months|Entire study population was analyzed||percentage of participants|||Number
31844|NCT01573325|Primary|Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.|Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.|2-3 months|Entire study population was analyzed||scores on a scale||Standard Deviation|Mean
31845|NCT01573260|Secondary|Adverse Events|Adverse events will be queried week 12 through a semi structured interview querying increase in falls, fatigue, pain, cramps or pain, in addition to open-ended questions regarding other potential adverse events. Events will be rated by the patient and investigator as mild, moderate, or serious. All serious adverse events will be reported to the research ethics board|12 weeks|||percentage of participants|||Number
31846|NCT01573260|Secondary|Exit Questionnaire|An exit questionnaire ranking level of enjoyment and overall satisfaction with their dance/exercise program, scored from 1 (strongly agree) to 5 (strongly disagree), with open questions about willingness continuing practicing tango.|12 weeks|||units on a scale||Standard Deviation|Mean
31847|NCT01573260|Secondary|Clinical Global Impression of Change|"Completed by both the examiner and the patient, the scale is a single question Since you have enrolled in the study, how has your Parkinson's disease changed?. It will be scored as very much improved (6), much improved (5), minimally improved (4), no change (3), minimally worse (2), much worse (1), or very much worse(0)."|26 weeks|||units on a scale||Standard Deviation|Mean
31848|NCT01573260|Secondary|Adherence to Treatment|Compliance with dance therapy will be conducted by reconfirming the regular assistance to the dance sessions at week 12, to compare how many sessions were attended by the participants. The dance instructors will keep the track of dance classes’ assistance.|12 weeks|||participants|||Number
31849|NCT01573260|Secondary|The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)|The PDQ-39 is a quality of life index for PD. It consists of a 39-item questionnaire that asks about the impact of PD on a person's motor function, gait, mood, cognition, and activities of daily living. Patients are asked to indicate the frequency of each event by selecting one of 5 options: never/occasionally/sometimes/often/always or cannot do at all. Total score is ranging from 0 (best possible outcome) to 156 (worst possible quality of life).|26 weeks|||score||Standard Deviation|Mean
31850|NCT01573260|Secondary|The Krupp Fatigue Severity Scale|The fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question It has been validated, and has been used in PD studies. Total score is ranging from 0 (best possible outcome) to 63 (worst possible fatigue).|26 weeks|||score||Standard Deviation|Mean
32148|NCT01567943|Secondary|Community Outcomes|(jail bookings, ER visits, mental health and substance abuse service utilization)|entire study period, and three month prior and after study involvement||||||
31853|NCT01573260|Secondary|The Montreal Cognitive Assessment|"This tool was designed to screen for mild cognitive impairment. This includes visuospatial tests (clock drawing, trail making, cube copying), confrontation naming, attention (digit span, backwards digit span, A test, sentence repetition), tests of verbal fluency, abstraction, short term memory, and orientation. Recently, it has been used widely in PD, and demonstrates excellent sensitivity for subtle cognitive deficits. Alternate versions (7.1 to 7.3, with a randomly-distributed order) will be administered to prevent training effects. Total score for the MoCA is the sum of eight subscales, ranging from 0 (worst possible outcome) to 30 (best possible symptoms)"|26 weeks|||score||Standard Deviation|Mean
31854|NCT01573260|Secondary|The Purdue Pegboard|The Purdue Pegboard, a test of dexterity and speed in the hands will be assessed over 1 minute. We calculate the number of pins correctly placed on the board in a minute.|26 weeks|||correct pins per 60 sec||Standard Deviation|Mean
31855|NCT01573260|Secondary|Freezing of Gait Questionnare (FOG_Q)|Freezing of gait will be assessed using the Freezing of Gait Questionnare (FOG_Q), a 6-item tool measuring walking and freezing episodes. Higher scores indicate greater difficulty with walking and freezing. Six items each scored from 0 to 6 were summed to obtain the total score, ranging from 0 (best possible outcome) to 36 (worst possible outcome).|26 weeks|||units on a scale||Standard Deviation|Mean
31856|NCT01573260|Secondary|Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging|Falls will be assessed using an adapted version of the falls questionnaire from the Canadian Longitudinal Study of Aging focusing on the past 3 months. This questionnaire includes 2 questions to assess if the participants felt during the past year and then it assess if this fall happened within the last 3 months. If a participant answered 'yes' to both questions, then the participant screened positive for this outcome. In the results section, we reported the number of participant who answered 'Yes' to both questions.|26 weeks|||participants|||Number
31857|NCT01573260|Secondary|MiniBESTest|Balance will be assessed using a 14-item tool measuring performance of dynamic balance tasks. This test has high interrater and test-retest reliability in PD (intraclass correlation coefficient ≥ .92 and intraclass correlation coefficient ≥.88 respectively). Total score for MiniBESTest is the sum of foursubscales, ranging from 0 (worst possible balance) to 28 (best possible balance). Lower scores indicate greater deficits in balance. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, we used of both left and right data, thus calculating data based on 32 (vs 28) points.|26 weeks|||units on a scale||Standard Deviation|Mean
31858|NCT01573260|Primary|Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)|This is the standard scale used for grading severity of PD. It starts with a patient self-administered questionnaire covering activities of daily living, motor symptoms, and non-motor domains. It also includes a systematic rated clinical interview assessing cognitive and psychiatric symptoms and motor complications of disease. A Hoehn and Yahr scale (5-point overall disease severity index) is included. Finally, there is a formal examination component (Part III) (performed in the medication 'on' state for this study). Total score for Unified Parkinson Disease Rating Scale is the sum of six subscales, ranging from 0 (best possible outcome) to 60 (worst possible symptoms)|26 weeks|||units on a scale||Standard Deviation|Mean
31859|NCT01573000|Secondary|Time to Human Anti-Murine Antibodies (HAMA) Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of human anti-mouse antibodies.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were evaluated.||days||Standard Deviation|Mean
31860|NCT01573000|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|"ITT-Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."||days||Full Range|Median
31861|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||participants|||Number
31862|NCT01573000|Secondary|Nadir Values for the Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||cells/microliter||Full Range|Median
31863|NCT01573000|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||Grams/dL||Full Range|Median
32149|NCT01567943|Secondary|Other Drug Use as Measured by Urinalysis||through 7 months of study||||||
32150|NCT01567943|Secondary|Self Report Drug Use||through 7 months of study||||||
32151|NCT01567943|Secondary|Change in Intensive Outpatient Substance Abuse Treatment Attendance||During 16 weeks of treatment||||||
31864|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST confirmed PR. Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
31865|NCT01573000|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated.||Cells/millimeters cubed (mm^3)||Full Range|Median
31866|NCT01573000|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values. Hematologic laboratory evaluations included ANC, hemoglobin (Hb), platelets (Plt), and WBC count.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated. The numbers analyzed in the category titles reflect the number of participants with the event of interest plus the number of participants who were censored. A censored value indicates that the participant did not have the event of interest.||days||Full Range|Median
31867|NCT01573000|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any fatal SAE were analyzed.||participants|||Number
31868|NCT01573000|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any SAE were analyzed.||participants|||Number
31869|NCT01573000|Secondary|Number of Participants With a Time to Death From the Last Dose of Study Drug Less Than or Equal to 30 Days or More Than 30 Days|"Time to death from the last dose of study drug is the time from the last dose of study drug administered to the date of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.||participants|||Number
31870|NCT01573000|Secondary|Number of Participants With the Indicated Primary Cause of Death|"Participants were categorized according to their primary cause of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.||participants|||Number
31871|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Drug-related AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 drug-related AEs experienced by 3 or more participants were analyzed.||participants|||Number
31872|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 AEs experienced by 3 or more participants were analyzed.||participants|||Number
31873|NCT01573000|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.||participants|||Number
31874|NCT01573000|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population||participants|||Number
31875|NCT01573000|Secondary|Number of Participants With the Indicated Drug-Related (DR) Adverse Events (AEs) Experienced by 3 or More Participants|"An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Causality of AEs was determined by the investigators as none, remote, possible, probable, or highly probable. AEs considered by the investigator as being at least remotely related to the study treatment were considered to be DR AEs. White blood cell (WBC) count and absolute neutrophil count (ANC) were measured as cells per millimeters cubed (mm^3); hemoglobin was measured in grams per deciliter (g/dL)."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any drug-related adverse events were analyzed.||participants|||Number
31876|NCT01573000|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death by any cause.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
31877|NCT01573000|Secondary|MIRROR Panel Assessed Progression-free Survival|Time from the date of enrollment (the date of randomization) to the first documented progression or death.|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||months||95% Confidence Interval|Median
31878|NCT01573000|Secondary|MIRROR Panel Assessed Time to Response (Time From the Date of Enrollment to the First Documented Response (PR, CR, CCR)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||days||95% Confidence Interval|Median
31879|NCT01573000|Secondary|Time to Progression of Disease or Death in Participants Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment and those who progressed/died were analyzed. Participants who experienced progression or died (n=18, 17) and participants who were censored (n=1, 2) were analyzed. A censored value indicates that the participant did not have the event of interest.||months||95% Confidence Interval|Median
31880|NCT01573000|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who experienced progression or died (n=36, 33) and participants who were censored (n=6, 3) were analyzed. A censored value indicates that the participant did not have the event of interest.||months||95% Confidence Interval|Median
31881|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Confirmed Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||months||95% Confidence Interval|Median
31882|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Complete Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.||months||95% Confidence Interval|Median
32106|NCT01568112|Secondary|Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results|Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not abnormal and who had at least 1 post-baseline value.||participants|||Number
31883|NCT01573000|Secondary|Duration of Response for All Confirmed Responders, Confirmed Complete Responders, and Confirmed Partial Responders|For all participants with CR, CCR, or PR, duration of response was defined as the time from first documented response to first documented progression. All confirmed responders included participants with CR, CCR, and PR, whereas confirmed complete responders included participants with CR and CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for CR, CCR, or PR were analyzed.||months||95% Confidence Interval|Median
31884|NCT01573000|Secondary|Number of Participants (Par.) With a Confirmed Response (CR, CCR, or PR) as Assessed by the MIRROR Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
31885|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
31886|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR + CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
31887|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
31888|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CCR. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
31889|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
31890|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
31891|NCT01573000|Primary|Number of Participants (Par.) With a Confirmed Complete Response as Assessed by the Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
31892|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
32152|NCT01567943|Primary|Change in Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine|Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive|During 16 weeks of treamtent|||EtG Value (ng/mL)||Standard Error|Mean
31893|NCT01573000|Primary|Number of Participants With Confirmed Response Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease (defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters [cm] in diameter by radiographic evaluation or >1 cm in diameter by physical examination.) were assessed separately before and after receiving the crossover treatment of I 131 TST for confirmed response, which included participants with CR, CCR, and PR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.||participants|||Number
31894|NCT01573000|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
31895|NCT01572948|Secondary|Induced Sputum Neutrophil Count||3 months after baseline|||percentage of sputum neutrophils||Standard Error|Mean
31896|NCT01572948|Secondary|Induced Sputum Neutrophil Count||baseline|||percentage of sputum neutrophils||Standard Error|Mean
31897|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization||3 months after baseline|||ng/ml||Standard Deviation|Mean
31898|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.||1 month after baseline|||ng/ml||Standard Deviation|Mean
31899|NCT01572948|Secondary|Induced Sputum Neutrophil Count||1 month|||percentage of sputum neutrophils||Standard Error|Mean
31900|NCT01572948|Primary|Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline||baseline|||ng/ml||Standard Deviation|Mean
31901|NCT01572740|Secondary|Number of Confirmed Hypoglycaemic Episodes|"A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.~Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL)."|Week 0 to week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.||Episodes/100 years of patient exposure|||Number
31902|NCT01572740|Secondary|Number of Adverse Events (AEs)|An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Week 0 to Week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.||Events/100 years of patient exposure|||Number
31903|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 36|Estimated mean change in body weight after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.||kg||Standard Error|Mean
31904|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 16|Estimated mean change in body weight after 16 Weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.||kg||Standard Error|Mean
31905|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 13 subjects did not contribute to the statistical analysis at Week 36 due to missing data.||mmol/L||Standard Error|Mean
31906|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.||mmol/L||Standard Error|Mean
31907|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 8 subjects did not contribute to the statistical analysis at Week 36 due to missing data.||mmol/L||Standard Error|Mean
32225|NCT01566461|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (n=331)||Percentage of participants|||Number
31908|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.||mmol/L||Standard Error|Mean
31909|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.||mmol/L||Standard Error|Mean
31910|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|Estimated mean change from baseline in FPG after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.||mmol/L||Standard Error|Mean
31911|NCT01572740|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36|Estimated mean change from baseline in HbA1c after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.||percentage of glycosylated haemoglobin||Standard Error|Mean
31912|NCT01572740|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16|Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.||percentage of glycosylated haemoglobin||Standard Error|Mean
31913|NCT01572727|Secondary|Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)|Time to definitive deterioration of the ECOG performance status from baseline|every 4 weeks|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the time to definitive deterioration of ECOG performance status was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
31914|NCT01572727|Secondary|Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)|Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days|Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the plasma concentration-time profiles was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
31915|NCT01572727|Secondary|Clinical Benefit Rate (CBR) (Phase ll)|CBR was defined as the percentage of patients with an overall response of CR or PR or SD or non-CR/non-PD lasting more than 24 weeks based on local Investigator’s assessment according to RECIST v1.1.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.||Percentage of participants||95% Confidence Interval|Number
31916|NCT01572727|Secondary|Time to Response (Phase Lll)|time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, time to response was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
31917|NCT01572727|Secondary|Duration of Response (Phase Lll)|time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the duration of response was removed as a secondary endpoint in the final analysis and consequently not analyzed.|||||
31918|NCT01572727|Secondary|Overall Response Rate (Phase ll)|Percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. According to this criteria, CR = at least two determinations of CR at least 4 weeks apart before progression; PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.||Percentage of participants||95% Confidence Interval|Number
31919|NCT01572727|Secondary|Overall Survival by Kaplan-Meier Estimate (Phase ll)|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.|every 3 months until death, lost to follow-up, or withdrawal of consent to survival follow-up, up to 10 months after futility was analyzed|Full analysis set (FAS) comprises all patients who were randomized to study treatment.||Months||95% Confidence Interval|Median
31920|NCT01572727|Primary|Progression-free Survival (PFS)Assessed by Local Investigator’s Assessment (Phase ll)|PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.||Months||95% Confidence Interval|Median
31921|NCT01572675|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study||Participants|||Number
31922|NCT01572675|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study||Participants|||Number
31923|NCT01572675|Secondary|Number of Participants With Contraindications for Use of Arcoxia®|Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.|At study entry|The safety population consisting of all participants who enrolled in the study with data of sufficient quality for analysis of the endpoint (contraindications)||Participants|||Number
31924|NCT01572675|Secondary|Number of Participants Switching to Another Treatment With the Same Reason for Prescription|Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
31925|NCT01572675|Secondary|Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®|Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (other prior agents)||Participants|||Number
31926|NCT01572675|Secondary|Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®|Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.|Up to 12 months|All participants in compliance with study inclusion criteria with at least one follow-up visit (with an available prescription file) other than the end-of-study visit were used for analysis of the endpoint||Participants|||Number
31927|NCT01572675|Secondary|Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-prescriptions at entry)||Participants|||Number
31928|NCT01572675|Secondary|Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®|'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (past treatments)||Participants|||Number
31929|NCT01572675|Secondary|Co-morbidities in Participants Treated With Arcoxia® and Celebrex®|Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-morbidities)||Participants|||Number
31930|NCT01572675|Secondary|Medical History of Participants Treated With Arcoxia® and Celebrex®|Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (medical history)||Participants|||Number
31931|NCT01572675|Secondary|Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BP)||Participants|||Number
31933|NCT01572675|Secondary|Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BMI)||kg/m^2||Standard Deviation|Mean
31934|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use According to Duration of Treatment|Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
31935|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use|The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
31936|NCT01572675|Primary|Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®|The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
31937|NCT01572675|Primary|Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®|Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||mg/day||Standard Deviation|Mean
31938|NCT01572675|Primary|Total Duration of Treatment With Arcoxia® and Celebrex®|The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)||Days||Standard Deviation|Mean
31939|NCT01572675|Primary|Duration of Prescription for Arcoxia® and Celebrex® at Enrollment|The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)||Days||Standard Deviation|Mean
31940|NCT01572675|Primary|Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®|Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||Participants|||Number
31941|NCT01572675|Primary|Mean Dosage of Arcoxia® and Celebrex® During Treatment|The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.||mg/day||Standard Deviation|Mean
31942|NCT01572675|Primary|Dosage of Arcoxia® and Celebrex® at Initiation|Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (dosage at initiation)||Participants|||Number
32021|NCT01569763|Primary|Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months|Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.|12 months|All Randomized subjects in whom treatment was attempted||participants|||Number
31944|NCT01572675|Primary|Reasons for Misuse of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (misuse)||Participants|||Number
31945|NCT01572675|Primary|Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|All participants with complete data relative to correct use of the coxib and at least 1 data point relative to misuse of the coxib.||Participants|||Number
31946|NCT01572298|Secondary|Percentage of New Bone Formation (Histologic)||5 months after surgery||||||
31947|NCT01572298|Primary|Gain in Horizontal Ridge Dimension||5 months after surgery|||gain in ridge width (mm)||Standard Deviation|Mean
31948|NCT01572207|Secondary|Changes From Baseline in Quality of Life|The Multiple Sclerosis Impact Scale will be administered. The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome). Therefore, the lower the number, the better the outcome.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).|||scores on a scale||Full Range|Mean
31949|NCT01572207|Secondary|Changes From Baseline in Physical Fitness|The physical assessment will include measuring the 6-minute walk test. The units reported are in meters for distance traveled by each participant during the six minutes. For this scale, the higher number is the better score as it is a direct measure of distance traveled.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).|||meters||Full Range|Mean
31950|NCT01572207|Primary|Changes From Baseline in Physical Activity Behavior|"Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean.~With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity."|Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).|||scores on a scale||Full Range|Mean
31951|NCT01571557|Secondary|Mean Change From Baseline in Central Retinal Thickness|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.|Baseline, Week 24|All enrolled patients with complete data at this time point||micrometers (μm)||Standard Deviation|Mean
31952|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.|Baseline, 48 Weeks|All enrolled patients||Percentage of Patients|||Number
31953|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.|Baseline, 48 Weeks|All enrolled patients||Percentage of Patients|||Number
31996|NCT01570244|Primary|AUCt,ss of Ethinylestradiol|Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, who did not have important protocol violations relevant to the evaluation of PK endpoints, and who did not have vomiting until 2·median tmax,ss of ethinylestradiol or levonorgestrel on Day 13 or on Day 8.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
31954|NCT01571557|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.|Baseline, Week 12|All enrolled patients with complete data at this time point||Approximate EDTRS Letters||Standard Deviation|Mean
31955|NCT01571453|Secondary|Number of Adverse Events||Baseline to Week 12||||||
31956|NCT01571453|Secondary|Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||percentage of patients|||Number
31957|NCT01571453|Secondary|MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||percentage of patients|||Number
31958|NCT01571453|Secondary|Change in HAM-A Total Score From Baseline to Week 8|Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
31959|NCT01571453|Secondary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.|Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
31960|NCT01571453|Secondary|Change in CGI-S Score From Baseline to Week 8|Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
31961|NCT01571453|Primary|Change From Baseline in MADRS Total Score at Week 8|Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.||units on a scale||Standard Error|Mean
31962|NCT01570751|Secondary|Number of Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.|From baseline to the end of each 16 week treatment period.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
31963|NCT01570751|Secondary|Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.|Week 16, week 20|The FAS included all randomised subjects and missing data was imputed using LOCF. For 19 subjects the FPG values were missing.||mmol/L||Standard Deviation|Mean
31964|NCT01570751|Secondary|Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period|Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.|Week 0, week 16, week 32|The FAS included all randomised subjects and missing data was imputed using LOCF. For 17 subjects in IDeg treatment A and 16 subjects in IGlar treatment B, FPG values were missing at the period of baseline and did not contribute to the analysis.||mmol/L||Standard Deviation|Mean
31965|NCT01570751|Secondary|Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 16, week 20|The FAS included all randomised subjects. For 10 subjects, the PRO scores were missing.||scores on a scale||Standard Deviation|Mean
32018|NCT01569815|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5|||hr||Full Range|Median
31966|NCT01570751|Secondary|Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period|Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure–Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 0, week 16 of each treatment period.|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects in each treatment group the values were missing at the period of baseline and did not contribute to the analysis.||scores on a scale||Standard Deviation|Mean
31967|NCT01570751|Primary|Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period|Values for change in HbA1c after each 16 weeks of treatment periods A and B.|Week 0, week 16 of each treatment period.|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects in IDeg treatment A and 7 subjects in IGlar treatment B, HbA1c values were missing at the period of baseline and did not contribute to the analysis.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
31968|NCT01570686|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||8 weeks|Safety Set (SAF): consisted of all patients who received at least one dose of randomized study medication.||Patients|||Number
31969|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRC are included in this analysis.||ng/L||Standard Deviation|Mean
31970|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Activity (PRA)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRA are included in this analysis.||ng/mL/hr||Standard Deviation|Mean
31971|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.||Hour||Standard Deviation|Mean
31972|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.||ng*h/mL||Standard Deviation|Mean
31973|NCT01570686|Secondary|Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations||ng/mL||Standard Deviation|Mean
31974|NCT01570686|Secondary|Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction|Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting SBP measurement at baseline and over 8 weeks were included in this analysis.||Percentage of patients|||Number
31975|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with official mean sitting blood pressure measurements both at baseline and week 8 were icluded in this analysis.||mmHg||Standard Error|Least Squares Mean
31976|NCT01570686|Secondary|Percentage of Patients Achieving Blood Pressure Control|Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg|8 weeks|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting blood pressure measurement over 8 weeks were included in this analysis.||Percentage of patients|||Number
32019|NCT01569763|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Randomized subjects||participants|||Number
31977|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.||mmHg||Standard Error|Least Squares Mean
31978|NCT01570686|Primary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.||mmHg||Standard Error|Least Squares Mean
31979|NCT01570634|Secondary|Side-effects and Complications|Compare side-effects and complications|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
31980|NCT01570634|Secondary|Absence of Relapse|Compare sustained clinical response|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
31981|NCT01570634|Secondary|Resolution of Abdominal Pain|Compare time to resolution of abdominal pain|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
31982|NCT01570634|Secondary|Stools Per Day|Compare the number of liquid stools per day during treatment period|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.|||||
31983|NCT01570634|Primary|Resolution of Diarrhea|To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).|42 days|The study was terminated early due to slow enrollment. Of the 2 patients enrolled, one took less than 50% of the prescribed study drug. The results are not evaluable.|||||
31984|NCT01570309|Primary|Inflammation|Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups|Baseline to week 12|||pg/ml||Inter-Quartile Range|Median
31985|NCT01570309|Primary|Inflammation|Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks|||pg/ml||Inter-Quartile Range|Median
31986|NCT01570309|Primary|Inflammation|Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks|||pg/ml||Inter-Quartile Range|Median
31987|NCT01570309|Primary|Inflammation -|Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups|Baseline and 12 weeks|||mg/dl||Inter-Quartile Range|Median
31988|NCT01570309|Primary|Endothelial Function|Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post –to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.|Baseline and 12 weeks|Assuming a standard deviation of 0.6 in the change in RH-PAT score from baseline to 12 weeks, we estimated that the study would need a sample size of 45 patients per treatment group to have 80% power at a two tailed alpha=0.05 level to detect a minimum difference in change in RH-PAT score of 0.36 between treatment groups.||reactive hypermia index||Inter-Quartile Range|Median
31989|NCT01570244|Primary|C24,ss of Levonorgestrel|measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
31990|NCT01570244|Primary|Cmax,ss of Levonorgestrel|maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
31991|NCT01570244|Primary|AUCτ,ss of Levonorgestrel|Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
31992|NCT01570244|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events|from drug administration up to 14 days|treated set||participants|||Number
31993|NCT01570244|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 14 days|Treated set: This subject set included all 16 subjects who were administered trial medication and were documented to have taken at least 1 dose of investigational treatment.||participants|||Number
31994|NCT01570244|Primary|C24,ss of Ethinylestradiol|measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||pg/mL||Geometric Coefficient of Variation|Geometric Mean
31995|NCT01570244|Primary|Cmax,ss of Ethinylestradiol|maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set||pg/mL||Geometric Coefficient of Variation|Geometric Mean
31997|NCT01569841|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Hypoglycemic episodes reported within each 6 week treatment period.|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
31998|NCT01569841|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Within each week 6 treatment period|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
31999|NCT01569841|Secondary|Glycosylated Haemoglobin (HbA1c)|HbA1c after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
32000|NCT01569841|Secondary|Fasting Plasma Glucose (FPG)|FPG after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||mmol/L||Standard Deviation|Mean
32001|NCT01569841|Secondary|Mean Interstitial Glucose (IG) Based on 14 Days of CGM|The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.|CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||mmol/L||Standard Deviation|Mean
32002|NCT01569841|Primary|Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)|Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.|CGM occured during the last 2 weeks of the 6 weeks treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.||hours||Standard Deviation|Mean
32003|NCT01569828|Primary|CLr After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set||(ml/hr)||Standard Deviation|Mean
32004|NCT01569828|Primary|CL/F After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set||(ml/hr)||Standard Deviation|Mean
32005|NCT01569828|Primary|T1/2 After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set||(hr)||Standard Deviation|Mean
32006|NCT01569828|Primary|AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set||(hr*ng/mL)||Standard Deviation|Mean
32007|NCT01569828|Primary|(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set||ng/mL||Standard Deviation|Mean
32008|NCT01569828|Secondary|24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers||5 days|||mmol/day||Standard Deviation|Mean
32009|NCT01569828|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set||hour||Full Range|Median
32010|NCT01569815|Secondary|Change in Mean 24-hours Sodium Clearance From Baseline to Day 7|Sodium clearance will be measured in urine from baseline until Day 7|From baseline to Day 7|FAS||mmol/day||Standard Deviation|Mean
32011|NCT01569815|Primary|Amount of Drug Excreted Into the Urine From Time Zero to 24-hours Post-dose (Ae0-24) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and Day 5|||ug||Standard Deviation|Mean
32012|NCT01569815|Primary|Renal Clearance From Plasma (CLr) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS||mL/hr||Standard Deviation|Mean
32013|NCT01569815|Primary|Accumulation Ratio (Racc) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS||Ratio (AUC0-24, day 5)/(AUC0-24, day 1)||Standard Deviation|Mean
32014|NCT01569815|Primary|Systemic Clearance From Plasma Following Extravascular Administration (CL/F) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|||mL/hr||Standard Deviation|Mean
32015|NCT01569815|Primary|Elimination Half-life (t1/2) After Multiple Dose (Day 5) Administration|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS||hr||Standard Deviation|Mean
32016|NCT01569815|Primary|Area Under the Concentration-time Curve (AUC0-24) From Time Zero to 24- Hour Post-dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5|FAS||ng*hr/mL||Standard Deviation|Mean
32017|NCT01569815|Primary|Maximum Peak Plasma Concentration (Cmax) Observed After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1, day 5|||ng/mL||Standard Deviation|Mean
32023|NCT01569464|Secondary|Change From Baseline in SF-36 Physical Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).~The SF–36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32024|NCT01569464|Secondary|Change From Baseline in SF-36 Mental Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).~The SF–36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32025|NCT01569464|Secondary|Change In Total Score From Baseline To The End of Maintenance Period On Profile Of Mood States Questionnaire (POMS)|"The Profile of Mood States questionnaire (POMS) total score will be calculated as the sum of the scores for the following 5 scale scores (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Fatigue-Inertia, and Confusion-Bewilderment) and then subtracting the Vigor-Activity score. All factors have to be available for the total score to be calculated; otherwise the total score will be set to missing. The range for the POMS is 0 - 200 with a high score being negative and a low score being positive.~For the POMS questionnaire total score, descriptive statistics will be presented on both the observed and the change from Baseline to the end of the Maintenance Period values for the Full Analysis Set (FAS)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32026|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Quantity Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (Sleep Scale-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32027|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Adequacy Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32036|NCT01569464|Secondary|Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT)|"During each single Suggested Immobilization Test (SIT) PLMWI was measured using a validated actigraphy device. Simultaneous actigraphy of the legs was performed by an actigraphy device, which was attached to the ankle prior to the start of the SIT. The PLMWI was recorded while the subject was awake.~Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 149 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32028|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Disturbance Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32029|NCT01569464|Secondary|Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep–R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32030|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = not at all) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32031|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32032|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32033|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32034|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32035|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = completely satisfied) to (10 = completely dissatisfied).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32226|NCT01566461|Secondary|Procedural Success|Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.|Day 1|Intention-to-Treat (n=331)||Percentage of participants|||Number
32037|NCT01569464|Primary|Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT)|"The Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) was used for assessment of the sensory components of Restless Legs Syndrome (RLS) symptoms in order to provide a subjective score of the severity of RLS symptoms during each Suggested Immobilization Test (SIT).~Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32038|NCT01569464|Primary|Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score|"The International Restless Legs Scale (IRLS) was intended to evaluate, in a standardized way, the subjective intensity of major symptoms of Restless Legs Syndrome (RLS) and, in 2 items (9 and 10), the impact of the disease on subjects functioning in daytime activities by use of a 5-point scale for each of a total of 10 items.~In all items, the scores ranged from 0 (not present) to 4 (severe). A sum score across all 10 items was calculated for analysis, which varied between 0 (no RLS symptoms present at all) to 40 (maximum severity in all symptoms)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."||units on a scale||Standard Error|Least Squares Mean
32039|NCT01569438|Secondary|Genitourinary Pain Index (GUPI)|The GUPI is an instrument that is used to assess the degree of symptoms in women with genitourinary pain complaints. The sum of the items yields three subscales and a total score. The subscales are pain (0-23), urinary (0-10), and quality of life (0-12). The sum of the subscales is the total score (0-45). Higher scores indicate more severe symptoms.|4 Weeks|Titration population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, and who titrated the dose in Week 1 of the treatment phase||units on a scale||Standard Deviation|Mean
32040|NCT01569438|Secondary|O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)|The ICSI contains 4 items that measured how problematic symptoms were for subjects with bladder pain syndrome. Each question in the ICPI was on a scale of 0-4, where each answer was given a specific rating. The sum of the item scores indicated more problematic symptoms. The index score ranged from 0-16 where higher scores indicated more problematic symptoms.|4 Weeks|Titration population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, and who titrated the dose in Week 1 of the treatment phase||units on a scale||Standard Deviation|Mean
32041|NCT01569438|Secondary|Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD)|The PBIC-SD was an 8-item subject self-report measure for assessing the severity of bladder pain syndrome. All items were graded on a scale from 0 (good condition) to 4 (poor condition) for a total score between 0 and 32.|4 Weeks|Titration population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, and who titrated the dose in Week 1 of the treatment phase||units on a scale||Standard Deviation|Mean
32042|NCT01569438|Primary|The Primary Efficacy Endpoint of This Study is Change From Baseline in the 'Average Pain' NPRS Score.|Subjects were instructed to select a number on a scale that best described the severity of bladder pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst pain possible. The scale was completed by telephone (an interactive voice response system[IVRS]) every evening at bedtime.|4 Weeks|Titration population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, and who titrated the dose in Week 1 of the treatment phase||units on a scale||Full Range|Mean
32043|NCT01569126|Secondary|Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals|The number of participants with a maximum increase from baseline in 12-lead electrocardiogram (ECG) QTcB and QTcF intervals >30 milliseconds (ms) and >60 ms for the single-dose (SD) and multiple-dose (MD) periods is reported.|Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period)|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.||participants|||Number
32044|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(tau,steady state) of plasma total fluoxetine and norfluoxetine during the MD period is reported.|Predose up to Day 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
32045|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-24) of plasma total fluoxetine and norfluoxetine on Day 1 of the MD period is reported.|Day 1|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
32046|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine on Day 1 and Day 28 of the MD period is reported.|Days 1 and 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
32107|NCT01568112|Secondary|Number of Participants With Abnormalities in Vital Signs|↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants who had a baseline value and had at least 1 post-baseline value.||participants|||Number
32047|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-infinity) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
32048|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-tlast) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
32049|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
32050|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 70|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug or placebo and had at least 1 postdose safety assessment.||participants|||Number
32051|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.||participants|||Number
32052|NCT01569087|Secondary|Incidence of Febrile Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||participants|||Number
32053|NCT01569087|Secondary|Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||days||Standard Deviation|Mean
32054|NCT01569087|Secondary|Low Level (Nadir) ANC x 10^9/L||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||cells x 10^9/L||Inter-Quartile Range|Median
32055|NCT01569087|Secondary|The Duration of Any Grade Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||days||Standard Deviation|Mean
32056|NCT01569087|Secondary|Mean Duration of CTCAE Grade 4 Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||days||Standard Deviation|Mean
32057|NCT01569087|Primary|CTCAE Grade 3/4 Neutropenia Incidence||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)||participants|||Number
32058|NCT01569074|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
32067|NCT01569074|Primary|Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
32153|NCT01567852|Primary|Recovery Time|Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.|1 hour|Please see description from outcome 1||minutes||Standard Deviation|Mean
32059|NCT01569074|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
32060|NCT01569074|Secondary|Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
32061|NCT01569074|Secondary|Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 12 was derived and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice a day, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
32062|NCT01569074|Secondary|Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient’s own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, , DMARD = disease modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
32063|NCT01569074|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 12|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient’s own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 12. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
32064|NCT01569074|Secondary|Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
32065|NCT01569074|Secondary|Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
32066|NCT01569074|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The fostamatinib 100 mg BID combined group contains 31 patients from Dosing Group A and 33 patients from Dosing Group B.||Percentage of responders|||Number
32068|NCT01568905|Secondary|Comparison of Number of Cigarettes Smoked|Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.|1 week|||cigarettes per week||Standard Deviation|Mean
32070|NCT01568905|Secondary|Change From Baseline of Modified Cigarette Evaluation Scale Response to Cigarettes|Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.|Baseline (Day 1) Compared to Second Visit (Week 1)|||units on a scale||Standard Error|Mean
32071|NCT01568905|Primary|Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1|Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.|Second Visit (Week 1) minus Baseline (Day 1)|||nmols/ml||Standard Error|Mean
32072|NCT01568892|Secondary|Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.||participants|||Number
32073|NCT01568892|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 96 study days)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.||participants|||Number
32074|NCT01568892|Secondary|Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24|Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24|Day 8, Day 28, and Week 24|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
32075|NCT01568892|Secondary|Cmax of DTG|The maximal concentration (Cmax) of DTG was assessed using a population PK modeling approach. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours (hrs) post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. Results from these PK parameters will be reported separately.|Day 8, Day 28, and Week 24||12/2014||||
32076|NCT01568892|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was assessed using a population pharmacokinetic (PK) modeling approach. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours (hrs) post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. Results from these PK parameters will be reported separately.|Day 8, Day 28, and Week 24||12/2014||||
32077|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks)|Safety Population||participants|||Number
32078|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks)|Safety Population||participants|||Number
32172|NCT01566981|Secondary|Change of the Following Parameter : HbA1C||baseline and six months||||||
32079|NCT01568892|Secondary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Day 8 analysis data cut-off date (average of 14 study weeks)|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
32080|NCT01568892|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until early withdrawal or the Day 8 analysis cut-off date (average of 14 study weeks)|ITT-E Population||participants|||Number
32081|NCT01568892|Secondary|Median Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Day 28|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline and Day 28. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline and Day 28|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeter||Inter-Quartile Range|Median
32082|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts at Baseline and Day 28|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline and Day 28.|Baseline and Day 28|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeter||Inter-Quartile Range|Median
32083|NCT01568892|Secondary|Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline, Day 8, Day 28, and Week 8. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeters||Inter-Quartile Range|Median
32084|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline, Day 8, Day 28, and Week 8.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Cells per cubic millimeters||Inter-Quartile Range|Median
32085|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, and Week 8, using the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||participants|||Number
32086|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, and Week 8, using the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||participants|||Number
32173|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and six months||||||
32087|NCT01568892|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, and Week 24. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Too few participants reached post-Week 8 study visits, hence only data through Week 8 are presented.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Log10 c/mL||Standard Deviation|Mean
32088|NCT01568892|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, and Week 24. Too few participants reached post-Week 8 study visits, hence only data through Week 8 are presented.|Baseline, Day 8, Day 28, and Week 8|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed.||Log10 c/mL||Standard Deviation|Mean
32089|NCT01568892|Primary|Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.|Baseline and Day 8|ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.||Log 10 copies per milliliter (c/mL)||Standard Error|Least Squares Mean
32090|NCT01568866|Secondary|Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)|Pulmonary artery pressure was measured using transthoracic echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available PASP data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."||mmHg||Standard Deviation|Mean
32091|NCT01568866|Secondary|Change From Baseline in Right Ventricular Fractional Area Change (FAC)|Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."||percent fractional area change||Standard Deviation|Mean
32092|NCT01568866|Secondary|Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)|"A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.~For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%."|Baseline and 24 weeks|Cardiopulmonary Safety Evaluable subgroup (all randomized participants who enrolled in the cardiopulmonary substudy with evaluable baseline echocardiogram scans per the central laboratory) and with both baseline and at least one post-baseline LVEF measurement within 24 weeks.||percentage of participants|||Number
32093|NCT01568866|Secondary|Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy|"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Safety population (all participants who received at least 1 dose of study treatment)||percentage of participants||95% Confidence Interval|Number
32094|NCT01568866|Secondary|Duration of Response|Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.|From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.|Intent-to-treat population with an overall response||months||95% Confidence Interval|Median
32108|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis|Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high or positive) and who had at least 1 post-baseline value.||participants|||Number
32174|NCT01566981|Secondary|Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.||baseline and one year||11/2013||||
32095|NCT01568866|Secondary|Overall Response|"Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
32096|NCT01568866|Secondary|Overall Survival|"Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient’s date of last contact (last known to be alive).~Median overall survival was estimated using the Kaplan-Meier method."|From randomization until the data cut-off date of 10 November 2014; median follow-up time for OS was 11.9 and 12.5 months for each treatment group respectively.|Intent-to-treat population||months||95% Confidence Interval|Median
32097|NCT01568866|Primary|Progression Free Survival|"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).~Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored."|From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively|Intent-to-Treat Population||months||95% Confidence Interval|Median
32098|NCT01568827|Primary|Serum IL-6|Area Under the time-concentration Curve (AUC) of IL-6|acute (0-12 hours) after inflammation-causing challenge meal|||(pg*hr)/mL||95% Confidence Interval|Mean
32099|NCT01568593|Primary|Global Ocular Staining (With Oxford Scale - Ranges :0-15)|Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)|Baseline and 35 days|Per Protocol Population||scores on a scale||Standard Deviation|Mean
32100|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 5 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.||hours||Standard Deviation|Mean
32101|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 1 to Week 4|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.||hours||Standard Deviation|Mean
32102|NCT01568112|Secondary|Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Day 1 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.||hours||Standard Deviation|Mean
32103|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 5 to Week 8|Participants with a flushing event.||minutes||Standard Deviation|Mean
32104|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 1 to Week 4|Participants with a flushing event.||minutes||Standard Deviation|Mean
32105|NCT01568112|Secondary|Duration of Flushing Events During the Overall Treatment Period, Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Day 1 to Week 8|Participants with a flushing event.||minutes||Standard Deviation|Mean
32175|NCT01566981|Secondary|Quality of Patients' Life Via WONCA-COOP Questionnaire.||baseline and one year||||||
32176|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and one year||||||
41842|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|4 years||||||
32109|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry|Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
32110|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Hematology|Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
32111|NCT01568112|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.|Day 1 up to end of Safety Follow-up (9 weeks)|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo).||participants|||Number
32112|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32113|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32114|NCT01568112|Primary|Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32115|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
32116|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
32117|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32139|NCT01568021|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.||letters||Standard Deviation|Mean
32118|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32119|NCT01568112|Primary|Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32120|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32121|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32122|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32123|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
32124|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||units on a scale||Standard Deviation|Mean
32125|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32140|NCT01568021|Primary|Time to First Re-treatment|Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.|1 Year|All Participants with complete data.||days||95% Confidence Interval|Median
32126|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32127|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.||percentage of participants|||Number
32128|NCT01568073|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3~Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4~The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.~The NMSS total score is calculated by adding all domain scores (0–360), and lower scores mean less disability."|14 to 15 weeks|||units on a scale||Standard Deviation|Mean
32129|NCT01568073|Secondary|Parkinson's Disease Sleep Scale (PDSS)|"The Parkinson’s disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.~Subscale has 0-10 ratings, where 0 = severe and 10 = normal~The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14 to 15 weeks|||units on a scale||Standard Deviation|Mean
32130|NCT01568073|Secondary|Total UPDRS SCORE (I, II (ON), and III)|"Total UPDRS (Part I, II (ON) and III)~UPDRS I evaluation of mentation, behavior, and mood~UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food~UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.~Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe~The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14 to 15 weeks|||units on a scale||Standard Deviation|Mean
32131|NCT01568073|Primary|Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo,|The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period, This results refers when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations|14 to 15 weeks|||minutes||Standard Error|Mean
32132|NCT01568047|Primary|Tmax - Time to Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days|||ng/mL||Full Range|Median
32133|NCT01568047|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days|||ng.h/mL||Standard Deviation|Mean
32134|NCT01568047|Primary|Cmax - Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days|||ng/mL||Standard Deviation|Mean
32135|NCT01568034|Primary|Tmax = Time to Cmax Day 3|tmax = time to Cmax (values are median)|Day 3|||hours||Full Range|Median
32136|NCT01568034|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)|AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)|Day 3|||ng.h/mL||Standard Deviation|Mean
32137|NCT01568034|Primary|Cmax - Maximum Plasma Concentration Day 3|Cmax - Maximum plasma concentration (ng/mL)|Day 3|||ng/ml||Standard Deviation|Mean
32138|NCT01568021|Secondary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.||microns||Standard Deviation|Mean
32141|NCT01568008|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.|Week 12|All patients with complete data available for IOP.||mm Hg||Standard Deviation|Mean
32154|NCT01567852|Primary|Re-orientation Time|Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.|1 hour|Since this was a crossover study, all patients received both drugs, except for 2 patients who dropped out after receiving the first drug. For one of these patients the drug was ketamine, for the other the drug was methohexital. Number of total trials analyzed was 69, with 35 Ketamine trials and 34 Methohexital trials||minutes||Standard Deviation|Mean
32155|NCT01567839|Primary|Successful Pulpal Anesthesia.|Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.|60 minutes|||participants|||Number
32156|NCT01567371|Secondary|Difference in Stroke Volume Variability From Baseline to Post ANH.|The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day|||% variability||Standard Deviation|Mean
32157|NCT01567371|Primary|Difference in Pulse Pressure Variability From Baseline to Post-ANH|The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day|||% variability||Standard Deviation|Mean
32158|NCT01567163|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2.||micrograms/milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
32159|NCT01567163|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2.||micrograms*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
32160|NCT01567163|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment who had immunogenicity samples collected at the specified time points.||participants|||Number
32161|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 2.||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
32162|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 1.||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
32163|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 2.||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
32164|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 1.||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
32165|NCT01567150|Secondary|Wound Healing|change in wound area mean was calculated for each subject Mean and sd were calculated for each group|12 weeks|average across 12 week time frame||square cm||Standard Deviation|Mean
32166|NCT01567150|Primary|Matrix Metalloproteinase Level in Wound Fluid|"Wound fluid will be collected and analyzed at baseline and approximately every 7 days.~Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups."|8 weeks|Overall mean across 8 week timeframe||mcg/ml||Standard Deviation|Mean
32167|NCT01567020|Secondary|Number of Participants With Decreased Amplitudes or Increased Latencies in Electrophysiological Tests of Central Auditory Function|"Tests to be administered:~Auditory Brainstem Response Long Latency Response"|six months||||||
32168|NCT01567020|Secondary|Functional Hearing Ability in Multitalker Environments||six months||||||
32169|NCT01567020|Secondary|Comprehensive Audiological Examination||six months||||||
32170|NCT01567020|Secondary|Number of Participants With Abnormal Ratings of Self-reported Ability to Process Auditory Information in Various Settings|"Questionnaires to be administered:~Hearing Health Inventory Speech, Spatial, and Qualities of Hearing"|six months||||||
32171|NCT01567020|Primary|Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing|"Tests to be administered:~Dichotic Digits Test: Percentage of digits reported correctly from 0 (worst performance) to 100 (best performance) Gaps in Noise Test: Approximate threshold in milliseconds from 2 (best) to 20 (worst) Staggered Spondaic Words Test: Total number of errors from 0 (best) to 40 (worst) Masking Level Differences Test: Difference in threshold between diotic and dichotic stimuli in decibels from 0 (worst) to 24 (best) Frequency Pattern Test: Percentage of sequences reported correctly from 0 (worst performance) to 100 (best performance) Adaptive Tests of Temporal Resolution: Not reported due to software error in stimulus presentation"|six months|Note that some of the participants finished all of the primary outcome measures but withdrew without finishing all of the secondary tests. They are thus listed as having withdrawn but are still included here for completeness.||units on a scale||Standard Deviation|Mean
32177|NCT01566981|Secondary|Patients' Functional Health Status Via WONCA-COOP Questionnaire.|WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 (‘no limitation at all’) to 5 (‘severely limited’); for ‘change in health’ score 1 means ‘much better’ and score 5‘much worse’. Sub-scales are averaged to compute a total score.|one year|||units on a scale||Standard Deviation|Mean
32178|NCT01566981|Secondary|Body Mass Index at 1 Year||one year|||Kg/m2||Standard Deviation|Mean
32179|NCT01566981|Primary|Change From Baseline in HbA1C at 1 Year.||1 year|||percentage of glycated haemoglobin||Standard Deviation|Mean
32180|NCT01566838|Secondary|Resumed Physical Activity|Did the patient resume physical activity.|30 days|Resuming of physical activity||participants|||Number
32181|NCT01566838|Secondary|Return to Work|Returned to work in 30 days?|30 days|30 day return to work||participants|||Number
32182|NCT01566838|Secondary|30-day Incidence of Parasthesia|30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)|30 days|30-day incidence of paresthesia||participants|||Number
32183|NCT01566838|Secondary|Length of Stay|Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.|Participants will be followed for the duration of hospital stay, an expected average of 5 days|In-hospital length of stay (days)||days||Inter-Quartile Range|Median
32184|NCT01566838|Secondary|7-day Paresthesia|Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7|Postoperative day 1 through day 7|7-day paresthesia||participants|||Number
32185|NCT01566838|Primary|Number of Participants With and Without 30-Day Pain Medication Usage|The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.|Postoperative day 1 through postoperative day 30|30-day pain medication usage||participants|||Number
32186|NCT01566630|Secondary|Mean Number of Days Before Delivery||From randomization until delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32187|NCT01566630|Primary|Pharmacokinetics of RLX030: Mean Residence Time (MRT)|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32188|NCT01566630|Primary|Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32189|NCT01566630|Primary|Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32190|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32191|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to Infinity (AUCinf)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32192|NCT01566630|Primary|Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile||Randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32193|NCT01566630|Primary|Number of Patients With Abnormalities in Birth Weight, Gestational Age, Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Score, Umbilical Cord Gases, and Days in Neonatal Intensive Care Unit (NICU)||up to 4 - 6 weeks post partum (maximum of 8 weeks )|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32194|NCT01566630|Primary|Number of Patients With Absence of Anti-serelaxin Antibodies||From Randomization until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32195|NCT01566630|Primary|Rate of Spontaneous Delivery and/or Mode of Delivery||From randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32196|NCT01566630|Primary|Improvement in Renal Function Assessed by Increase in Creatinine Clearance||From randomization until 4-6 weeks post partum (maximum 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32197|NCT01566630|Primary|Change in Fetal Heart Rate (Part 1)|Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32198|NCT01566630|Primary|Decrease in Utero-placental Blood Flow (Part 1)|Blood flow to the fetus was monitored using via a Doppler.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32199|NCT01566630|Primary|Change From Baseline on Maternal Proteinuria (Part 1)|Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32224|NCT01566461|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Days||Standard Deviation|Mean
32200|NCT01566630|Primary|Change From Baseline in Mean Maternal Arterial Pressure (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32201|NCT01566630|Primary|Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed|||||
32202|NCT01566630|Primary|Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study|Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.|Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed.||Participants|||Number
32203|NCT01566604|Secondary|The Total Score of the St George's Respiratory Questionnaire (SGRQ)|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity and impacts. The lowest possible score is zero and the highest possible score is 100. Higher scores correspond to greater impairment in quality of life. The health-related quality of life was measured using SGRQ. It was completed by the participant at the investigators site.|Week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.||Score||Standard Error|Least Squares Mean
32204|NCT01566604|Secondary|Number of Moderate and Severe COPD Exacerbations|COPD exacerbations were recorded in the patient diary and other source documents. The rate of COPD exacerbations during the 26 week treatment period was analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.||Number of exacerbations||Standard Deviation|Mean
32205|NCT01566604|Secondary|Time to First Moderate or Severe COPD Exacerbation|A COPD exacerbation was defined as a worsening of the following two or more major symptoms for at least 2 consecutive days:1) dyspnea; 2) sputum volume; 3) sputum purulence; or defined as a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: 1) sore throat; 2) colds (nasal discharge and/or nasal congestion); 3) fever without other cause; 4) cough; 5) wheeze. COPD exacerbations were recorded in the patient diary and other source documents.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.||Days||Full Range|Median
32206|NCT01566604|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)|In an electronic diary, the participant responded to 6 questions twice daily to report on the degree of symptoms over the past 12 hours of the morning and evening. The questions covered the participant’s degree of overall symptoms, and degrees of individual symptoms of coughing, wheezing, amount of sputum, color of sputum and breathlessness. Each question scored from 0 to 3 where 0 represented no symptom present and 3 represented the worst degree of that symptom. A negative change in symptom score indicates improvement.|Baseline, 26 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given symptom category, analyzed participants had both baseline and week 26 values.||score||Standard Error|Least Squares Mean
32207|NCT01566604|Secondary|Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose|The standardized (with respect to time) AUC for FEV1 was calculated between 5 min and 4h post morning dose at day 1, week 12 and week 26. The AUC (5 min-4 h) for FEV1 at each visit was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.||Liters||Standard Error|Least Squares Mean
32208|NCT01566604|Secondary|Peak FEV1|Peak FEV1 was defined as the maximum FEV1 0-4 h post-dose. Peak Fev1 was measured at 45min and 15min pre-dose and up to 4h post dose at day 1, week 12 and week 26, using central spirometry according to ATS/ERS standardization. It was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.||Liters||Standard Error|Least Squares Mean
32209|NCT01566604|Secondary|FEV1 and Forced Vital Capacity (FVC)|FEV1 and FVC were measured using central spirometry according to ATS/ERS standardization. Both were analyzed using the same MIXED model as specified for the primary analysis.|Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, e.g. day 1, 5 min; day 1, 15 min, etc..||Liters||Standard Error|Least Squares Mean
32210|NCT01566604|Secondary|24h Trough FEV1|Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. This was measured using central spirometry according to ATS/ERS standardization. This was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, Week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1 or week 26.||Liters||Standard Error|Least Squares Mean
32211|NCT01566604|Secondary|Change From Baseline in Daily Rescue Medication Use (Number of Puffs)|The participant recorded the rescue medication taken in an electronic diary between visits and in the spirometry device during study visits. Daytime and nighttime rescue medication use (number of puffs) over 26 weeks was analyzed.|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study medication.||Number of puffs||Standard Error|Least Squares Mean
32212|NCT01566604|Secondary|Transition Dyspnea Index (TDI) Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during the treatment period using the TDI, which captures changes from baseline. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort, and each domain scored from -3 (major deterioration) to +3 (major improvement), giving an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Baseline, week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.||score||Standard Error|Least Squares Mean
32213|NCT01566604|Primary|Trough Forced Expiratory Volume in One Second (FEV1)|Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.|12 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, participants analyzed had both baseline and week 12 values.||Liters||Standard Error|Least Squares Mean
32214|NCT01566526|Secondary|Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 3 lines in BCVA.||Days||Full Range|Median
32215|NCT01566526|Secondary|Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 2 lines in BCVA.||Days||Full Range|Median
32216|NCT01566526|Secondary|Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.||Micrometers (µm)||Standard Deviation|Mean
32217|NCT01566526|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.||Percent of Participants|||Number
32218|NCT01566526|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.||Percent of Participants|||Number
32219|NCT01566526|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.||Letters||Standard Deviation|Mean
32220|NCT01566526|Primary|Time to OZURDEX® Re-Injection in the Study Eye|The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.|Up to 12 Months|All enrolled patients.||Days||Standard Deviation|Mean
32221|NCT01566500|Secondary|Score of Psychosocial Predictors of Adherence|The Fisher IMB (Information-Seeking, Motivation and Behavior) adherence questionnaire will measure what psychosocial factors that act as predictive of medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a twelve month recall period.|Enrollment||||||
32222|NCT01566500|Secondary|Score on Barriers to Medication Adherence|The Chesney Adherence Questionnaire will be used to measure side effects, drug use and other barriers to medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a four-week recall period.|Enrollment||||||
32223|NCT01566500|Primary|Raw Count of Number of Days of Medication Nonadherence|"The primary outcome of this study is medication adherence as measured by self report with a 4 day recall adherence questionnaire (Chesney, Ickovics, Chambers, et al., 2000).~The total number of Nonadherence days were counted, then divided by the total number of days for all participants."|Enrollment|Adults with self-reported epilepsy.||% of nonadherence days|||Number
32228|NCT01566461|Secondary|Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.~Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
32229|NCT01566461|Secondary|Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)|Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.|From baseline to 12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe. Data not collected in IN.PACT SFA I phase.||Meters||Standard Deviation|Mean
32230|NCT01566461|Secondary|Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.~EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
32231|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32232|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32233|NCT01566461|Secondary|Secondary Sustained Clinical Improvement|Freedom from target amputation and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of particpants|||Number
32234|NCT01566461|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32235|NCT01566461|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32236|NCT01566461|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32237|NCT01566461|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.||Days||Standard Deviation|Mean
32238|NCT01566461|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32239|NCT01566461|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32240|NCT01566461|Secondary|All-cause Death||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32241|NCT01566461|Secondary|Major Adverse Event (MAE) Composite|Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32242|NCT01566461|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of particpants|||Number
32243|NCT01566461|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
32244|NCT01566435|Secondary|Progression-free Survival (PFS)||Up to 10 years||03/2024||||
32245|NCT01566435|Secondary|Disease-free Survival (DFS) Rate||2 years|||percentage of participants|||Number
32246|NCT01566435|Secondary|Changes in Ki-67 Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||06/2016||||
32247|NCT01566435|Secondary|CR or PR at Regional Nodes||6 weeks (2 cycles of therapy)||06/2016||||
32248|NCT01566435|Secondary|Quality of Life (QOL)|"Assessed using questionnaires administered at 6 time points starting at baseline.~4 page questionnaire will assess physical, social, emotional, and functional well-being through questions designed specifically for patients with head and neck cancer.~An additional 4 question QOL survey will assess symptoms of peripheral neuropathy."|Through one year after completion of treatment||06/2016||||
32249|NCT01566435|Secondary|Changes in Secreted Protein Acidic and Rich in Cysteine (SPARC) Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|SPARC and Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||06/2016||||
32250|NCT01566435|Secondary|Compare Adverse Events From This Regimen to the ACCF Regimen|Type and grade of toxicity assessed by NCI-CTCAE version 3|From start of treatment through 30 days after end of treatment||06/2016||||
32251|NCT01566435|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who are alive at 2 years.|2 years|||percentage of participants|||Number
32252|NCT01566435|Secondary|Metabolic Tumor Response by FDG-PET/CT|"Complete metabolic response (CMR): Complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions~Partial metabolic response (PMR): 20% or greater decrease in max SUV from baseline, no metabolic progression of non-target lesions and no new lesions and/or decrease in total number of non-target lesions, no new lesions~Stable metabolic disease (SMD) - does not qualify for CMR, PMR, or PMD~Progressive metabolic disease (PMD): development of one or more metabolically active lesions or 20% or greater increased in max SUV from baseline, new metabolically active lesions"|6 weeks (2 cycles of therapy)||06/2016||||
32253|NCT01566435|Secondary|Number of Participants Per Anatomic Tumor Response by CT Scan|"Response assessed using RECIST criteria version 1.0~Complete response: disappearance of all target lesions~Partial response: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter~Non-complete response/non-progression: persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal.~Progression: at least a 20% increase in the sum of the LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 weeks (2 cycles of therapy)|||participants|||Number
32254|NCT01566435|Secondary|Percentage of Participants With Partial Response (PR) at Primary Tumor Site|"Response will be assessed by laryngoscopy.~PR: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter"|6 weeks (2 cycles of therapy)|||percentage of participants|||Number
32255|NCT01566435|Primary|Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site|"Response will be assessed by laryngoscopy.~CR: disappearance of all lesions"|6 weeks (2 cycles of therapy)|||percentage of participants|||Number
32256|NCT01566409|Secondary|Usage of Laxative||½ year||||||
32257|NCT01566409|Primary|Treatment Recovery|Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.|½ year|||participants|||Number
32258|NCT01566370|Secondary|Change in Number of Drinks Per Week by Time|Comparison between medication and placebo groups on the change in number of drinks per week via interaction with time (from baseline to endpoint) using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32259|NCT01566370|Secondary|Change in Number of Heavy Drinking Days Per Week by Time|A comparison between medication and placebo on the measure of number heavy drinking days per week over the course of the study (baseline to endpoint) via interaction with time using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32260|NCT01566370|Secondary|Percentage of Total Drinking Days|The percentage of total drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|4 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32261|NCT01566370|Secondary|Change in Beck Depression Inventory (BDI) Scores|Comparison between groups on change in BDI scores over the 14 weeks of the study, measured weekly, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32262|NCT01566370|Secondary|Change in Gamma Glutamyl Transferase (GGT)|Difference between groups on change in levels of GGT over time, measured at baseline, week 5, week 9, week 13, and endpoint, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32263|NCT01566370|Secondary|Change in Alcohol Urge Questionnaire Score|This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures|from baseline to endpoint, 14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32264|NCT01566370|Secondary|Percentage of Abstinent Days|The difference in total percentage of abstinent compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|over four weeks, from week 11 through 14|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32265|NCT01566370|Primary|Change in Clinician Assisted Rating Scale for Mania (CARS-M) Scores|Comparison between groups on change in scores on the CARS-M over 14 weeks from baseline to endpoint, measured weekly and analyzed with repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32266|NCT01566370|Primary|Change on Hamilton Depression Rating Scale|Change from baseline to endpoint in Hamilton scores compared between medication and placebo, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32267|NCT01566370|Primary|Percentage of Total Heavy Drinking Days|The percentage of total heavy drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), totaled between the time-points of weeks 11 and 14 (4 weeks time frame).|from week 11 through 14 (over 4 weeks)|None of the subjects completed the study or made it to the 12 week endpoint.|||||
32268|NCT01566331|Primary|Partecipant With Perineal Laceration|The following types of lacerations were recorded during delivery: cervical laceration; mild perineal lacerations (defined as 1-2 lacerations); severe perineal lacerations (defined as 3-4 lacerations)|after delivery|intervention in normal pregnancies at term during labor and delivery||participants|||Number
32269|NCT01566162|Secondary|Intent to Attend Assessment|The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: “How likely is it that you will complete the study?”|12 weeks|Only 1825 subjects answered the questionnaire.||units on a scale||Standard Deviation|Mean
32270|NCT01566162|Secondary|Smoking Questionnaire|Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).|12 weeks|Only 36 subjects who were smokers had the smoker questionnaire assessments.||number of cigarettes smoked daily||Standard Deviation|Mean
32271|NCT01566162|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.|12 weeks|||percentage of monthly doses taken||Standard Deviation|Mean
32272|NCT01566162|Secondary|Modified Specific Levels of Functioning (SLOF) Total Score.|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.|12 weeks|Only 174 subjects had SLOF assessments at week 12 LOCF.||units on a scale||Standard Deviation|Mean
32273|NCT01566162|Secondary|Short Form-12 Health Survey (SF-12)|The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline SF-12.v2 assessments.||units on a scale||Standard Deviation|Mean
32274|NCT01566162|Secondary|Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline MADRS assessments.||units on a scale||Standard Deviation|Mean
32275|NCT01566162|Primary|Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint|||units on a scale||Standard Deviation|Mean
32276|NCT01566162|Primary|Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint|||units on a scale||Standard Deviation|Mean
32277|NCT01566162|Primary|Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)|Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)|12 weeks|||participants|||Number
32278|NCT01566149|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.|Baseline and Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication and had at least one efficacy measurement post-dose.||liters||Standard Deviation|Mean
32279|NCT01566149|Primary|Number of Participants Who Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
32280|NCT01566149|Primary|Number of Participants With At Least One Serious AE|"A serious AE was defined as any untoward medical occurrence or effect that at~any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer."|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
32281|NCT01566149|Primary|Number of Participants With At Least One Drug-Related AE|A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
32282|NCT01566149|Primary|Number of Participants With At Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 14|The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.||participants|||Number
32283|NCT01566084|Secondary|BH4 Bioavailability|Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability.|Immediately following acute administration of BH4 on Weeks 5 and 10|BH4 could not be administered to 3 participants due to canceled visits.||percentage dilation||Standard Deviation|Mean
32284|NCT01566084|Secondary|Vascular Oxidative Stress|Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative.|Immediately following acute infusion of ascorbic acid on Weeks 5 and 10|Ascorbic acid is missing in one participant due to a failed i.v.||percentage dilation||Standard Deviation|Mean
32285|NCT01566084|Primary|Improved Flow Mediated Dilation|FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks.|Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)|All subjects are analyzed under each condition because of the cross-over design.||percentage dilation||Standard Deviation|Mean
32286|NCT01565993|Secondary|Difficult to Place the Clip|The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.|During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)||||||
32287|NCT01565993|Primary|The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)|"In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called complications, despite their severity and clinical significance"|Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding|Based on an anticipated decrease of at least 12% in the rate of adverse bleeding events between the group A and the group B, there was an alpha error of 0.05 and a statistical power of 80% with a patient inclusion rate of 1:1. The number of polyps required is 146 per group. Using the Fleiss correction, the final number is 164 per group.||polyps|Participants||Number
32288|NCT01565980|Other Pre-specified|Baseline Values for All Measures.|Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.|Baseline.|||units on a scale||Standard Deviation|Mean
32289|NCT01565980|Other Pre-specified|Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)|The PSSQ_I has 13 self rated questions. The first 5 items, used to determine sleep quality (presence; frequency of insomnia problems) are rated [0 = never to 5 = always, 5-7 days per week; (range 0-25)] and items 6 to 13 are aimed at identifying the degree of interference experienced from sleep impairment (rated 0=not at all to 4=extremely on Likert scale; range 0 - 32).|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
32290|NCT01565980|Other Pre-specified|Worry (Cancer-related and General)|"Both cancer-related and general worry were measured with 3 item scales. Cancer-related worry had three statements asking about level of worry related to diagnosis, treatment, and worry interference using a 1 = not at all to 5 = most or all the time scale, range 3-15. Items are summed. General worry used an abbreviated brief Penn State Worry questionnaire with 3 statements that measure how typical that statements are in describing the person. Uses a 3 item scale with 1 = not at all typical to 5 = very typical. the range is 3-15. Items are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
32291|NCT01565980|Other Pre-specified|Cancer Dyspnea Scale|"The cancer dyspnea scale (CDS) has 12 Likert scale items ( 1 = Not at all, 5 = Very much) that ask questions about breathlessness or difficulty in breathing during the past few days. The CDS has an overall score (range 0-42) and 3 subscales that measure the amount of effort with breathing, anxiety associated with breathing, and discomfort associated with breathing.~The 3 subscales are calculated by: 1) effort (items 4+6+8+10+12) – 5 [range 0 (no dyspnea effort)-20 (worst dyspnea effort)]; 2) anxiety (items 5+7+9+11) – 4 [range 0 (no dyspnea anxiety) - 16 (worst dyspnea anxiety)]; 3) discomfort [15 – (items 1+2+3) {range 0 (no dyspnea discomfort) - 12 (worst dyspnea discomfort)}]. The total dyspnea score is derived by adding the total subscale scores. The subscale score subtractions are to make adjustments for 0 as a state of absence of dyspnea (thus total dyspnea summary scores range from 0 to 42)."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
32292|NCT01565980|Other Pre-specified|Center for Epidemiologic Studies Depression (CES-D)|The score is the sum of the 20 questions. Each item has a range of 1 - 4 for frequency of a behavior or mental state in the past week ; 1 - Rarely or none of the time (less than 1 day); 2 = Some or a little of the time (1-2 days); 3 = Occasionally or a moderate amount of time (3-4 days); 4 = Most or all of the time (5-7 days). Possible range is 0-60. There are 4 reverse-scored items (questions 4, 8, 12, and 16). A score of 16 points or more is considered depressed.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
32293|NCT01565980|Primary|SF-36|Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range). With normed scoring, general population has mean=50, SD=10. For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and standards error provided for T2 & 3, folllowed by summary of linear mixed effects models for the outcomes for group comparisons.||units on a scale||Standard Error|Least Squares Mean
32305|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7|"Cmax: maximum observed concentration of drug in plasma.~Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|Participants in the PK Analysis Set with available data were included.||ng/mL||Standard Deviation|Mean
32389|NCT01563406|Primary|Number of Central Venous Catheter Hubs With Internal Contamination|"This will be a qualitative outcome. It will be reported as yes or no for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms."|15 months|140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.||contaminated hubs|Participants||Number
32294|NCT01565980|Primary|M.D. Anderson Symptom Inventory (MDASI)|"Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom “at its worst” using 0–10 numerical rating scales with 0 = “not present” and 10 = “as bad as you can imagine.” The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = did not interfere; 10 = interfered completely). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and their standard errors are reported for times 2 and 3. The summary of linear mixed effects for group comparisons are then presented.||units on a scale||Standard Error|Least Squares Mean
32295|NCT01565902|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312|Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, α-fetoprotein [in hepatically impaired subjects only], pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, suicidality assessment (C-SSRS), (serious) adverse event monitoring.|Day -1 to 22|The safety analysis set consists of all subjects that received study drug and with no protocol deviations with relevant impact on safety.||Participants|||Number
32296|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment||(ng/mL)||Standard Deviation|Mean
32297|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment||h*ng/mL||Standard Deviation|Mean
32298|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment||h*ng/mL||Standard Deviation|Mean
32299|NCT01565889|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug(s)||percentage of participants|||Number
32300|NCT01565889|Other Pre-specified|Part B: On-treatment HIV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Safety Analysis Set: participants enrolled in Part B and received at least one dose of study drug(s).||copies/mL||Standard Deviation|Mean
32301|NCT01565889|Other Pre-specified|Part B: On-treatment HCV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Full Analysis Set||log10 IU/mL||Standard Deviation|Mean
32302|NCT01565889|Secondary|Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set||percentage of participants|||Number
32303|NCT01565889|Secondary|Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|"SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set||percentage of participants|||Number
32304|NCT01565889|Primary|Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Week 12|Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s)||percentage of participants|||Number
32347|NCT01565330|Secondary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|0-90 min after injection|||SUVR||Standard Deviation|Mean
32306|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7|"AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).~Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|"Pharmacokinetics (PK) Analysis Set: participants with evaluable PK profiles who enrolled into Part A of the study and received study drug.~Participants in the PK Analysis Set with available data were included."||h*ng/mL||Standard Deviation|Mean
32307|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.||cells/µL||Standard Deviation|Mean
32308|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.||cells/µL||Standard Deviation|Mean
32309|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.||log10 copies/mL||Standard Deviation|Mean
32310|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.||log10 copies/mL||Standard Deviation|Mean
32311|NCT01565850|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set||percentage of participants|||Number
32312|NCT01565850|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participant who were randomized;enrolled and received at least one dose of study drug||percentage of participants|||Number
32313|NCT01565707|Secondary|Change From Baseline in Post Void Residual (PVR) Volume|Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|The study analysis population for this endpoint consisted of the SAF.||mL||Standard Deviation|Least Squares Mean
32314|NCT01565707|Secondary|Number of Participants With Adverse Events (AEs)|A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.|From the first dose of study drug until 7 days after last dose of study medication (13 weeks).|The study analysis for this endpoint consisted of the Safety Analysis Set (SAF), the SAF consisted of all patients who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug.||participants|||Number
32315|NCT01565707|Secondary|Apparent Volume of Distribution (Vz/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||L||Standard Deviation|Mean
32316|NCT01565707|Secondary|Apparent Total Body Clearance (CL/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||L/h||Standard Deviation|Mean
32317|NCT01565707|Secondary|Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||hours||Standard Deviation|Mean
32318|NCT01565707|Secondary|Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||ng*h/mL||Standard Deviation|Mean
32319|NCT01565707|Secondary|Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||ng/mL||Standard Deviation|Mean
32320|NCT01565707|Secondary|Time to Attain Maximum Concentration (Tmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.||hours||Standard Deviation|Mean
32321|NCT01565707|Secondary|Maximum Concentration (Cmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS. The PKAS consisted of the subset of the Safety Analysis Set (SAF) for which plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of last dose prior to sampling was known.||ng/mL||Standard Deviation|Mean
32348|NCT01565330|Primary|Florbetapir-PET Scan Quality|Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).|0-90 min after injection|One subject in the 370 MBq (10 mCi) AD Group did not complete all imaging time periods||florbetapir scans|||Number
32349|NCT01565291|Secondary|Precuneus to Cerebellum SUVR|Ratio of uptake in the precuneus to uptake in the cerebellum.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.||SUVR||Standard Deviation|Mean
32322|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents|Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS including participants for whom data were available (adolescents only). Missing values at EoT were imputed using the last observation carried forward (LOCF) method.||urgency episodes||Standard Error|Least Squares Mean
32323|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||nighttime micturitions||Standard Error|Least Squares Mean
32324|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||daytime micturitions||Standard Error|Least Squares Mean
32325|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||micturitions||Standard Error|Least Squares Mean
32326|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days|The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||Dry Nights||Standard Error|Least Squares Mean
32327|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days|The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||Dry Days||Standard Error|Least Squares Mean
32328|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||nighttime incontinence episodes||Standard Error|Least Squares Mean
32329|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and Week 12|Full analysis set including patients for whom data were available. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.||daytime incontinence episodes||Standard Error|Least Squares Mean
32330|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||incontinence episodes||Standard Error|Least Squares Mean
32331|NCT01565707|Secondary|Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition|The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.||mL||Standard Error|Least Squares Mean
32350|NCT01565291|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.||SUVR||Standard Deviation|Mean
32332|NCT01565707|Primary|Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition|The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|Full Analysis Set (FAS) consists of all randomized patients that took at least one dose of double-blind study medication after randomization and provided both valid baseline and post-baseline values for the primary efficacy endpoint. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.||mL||Standard Error|Least Squares Mean
32333|NCT01565564|Secondary|The Rate of Pregnancy-induced Hypertension.|Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.|From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.|||participants|||Number
32334|NCT01565564|Primary|The Rate of Macrosomia.|Macrosomia is defined as birthweight ≥ 4000 gram.|At the time of birth.|||participants|||Number
32335|NCT01565551|Primary|Glasgow Outcome Scale Extended (GOSE)|The GOSE provides and overall measure of disability based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.|6 Months Post-Injury|||Glasgow Outcome Scale Extended (GOSE)||Inter-Quartile Range|Median
32336|NCT01565538|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.|||months||95% Confidence Interval|Median
32337|NCT01565538|Secondary|Best Tumor Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.|||participants|||Number
32338|NCT01565538|Primary|Progression-Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.|||months||95% Confidence Interval|Median
32339|NCT01565382|Secondary|Overall Inter-reader Agreement - Fleiss' Kappa|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.||Fleiss' kappa|Participants||Number
32340|NCT01565382|Primary|Inter-reader Agreement - Median Kappa Statistic|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.||median kappa|Participants||Number
32341|NCT01565369|Secondary|Inter-reader Agreement|Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers|50-60 min after injection|315 scans = 35 subjects x 9 readers||percentage of scans|Participants||Number
32342|NCT01565369|Primary|Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.|50-60 min after injection|16 of the 35 subjects had none or sparse plaques at autopsy||percentage of true negatives||Full Range|Median
32343|NCT01565369|Primary|Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.|50-60 min after injection|19 of the 35 subjects had moderate or frequent plaques at autopsy||percentage of true positives||Full Range|Median
32344|NCT01565356|Secondary|Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.|Scans acquired 30-40 min and 50-60 min post-injection|||weighted kappa||95% Confidence Interval|Number
32345|NCT01565356|Primary|Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.|Scans acquired 30-40 min and 50-60 min after injection|||percentage of agreement|||Number
32346|NCT01565343|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-70 min after injection|Due to poor subject positioning that resulted in an incomplete brain image on the retest image day, accurate quantitative analysis for one healthy control was not possible, and the subject was excluded from the SUVR-based analyses.||SUVR||Standard Deviation|Mean
32351|NCT01565083|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score|FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
32352|NCT01565083|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score|EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.||units on a scale||Standard Deviation|Mean
32353|NCT01565083|Secondary|Overall Survival (OS)|OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline until death (up to approximately 3.5 years)|ITT population||months||95% Confidence Interval|Median
32354|NCT01565083|Secondary|Percentage of Participants Who Died From Any Cause|Percentage of participants who died due to any cause was reported.|Baseline until death (up to approximately 3.5 years)|ITT population||percentage of participants|||Number
32355|NCT01565083|Secondary|Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1|TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||months||95% Confidence Interval|Median
32356|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||percentage of participants|||Number
32357|NCT01565083|Secondary|Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1|PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||months||95% Confidence Interval|Median
32358|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population||percentage of participants|||Number
32386|NCT01564693|Primary|ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE|We observed different BOLD signal in the region of the hypothalamus between the 3 groups. The BOLD signal and the activation/no activation areas were statistically analyzed by a specific statistical method (i.e., parametric mapping).|TIME 0 (BASELINE)|||BOLD||Standard Deviation|Mean
32390|NCT01564537|Secondary|Association Between Response or Resistance to Ixazomib Treatment and Proteasome and Nuclear Factor–kB (NF-kB)-Related Genes||At the time of screening; Day 1 of each cycle; at EOT; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||12/2020||||
32359|NCT01565083|Secondary|Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1|DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with a BOR of CR or PR and with measurable disease at baseline were included in the analysis.||months||95% Confidence Interval|Median
32360|NCT01565083|Secondary|Time to Response as Assessed by Investigator According to RECIST v 1.1|For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.||months||95% Confidence Interval|Median
32361|NCT01565083|Primary|Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
32362|NCT01564862|Secondary|Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline*week, center, week, treatment and week*treatment as factors was used for analyses."|Baseline, Week 1, Week 4 and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis. Repeated Measures Analysis.||score on a scale||Standard Error|Least Squares Mean
32363|NCT01564862|Secondary|Percentage of Participants in MADRS Remission at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10.|Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.||percentage of participants|||Number
32364|NCT01564862|Secondary|Percentage of Participants With MADRS Response at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.||percentage of participants|||Number
32365|NCT01564862|Secondary|Change From Baseline to Week 8 in the MADRS Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.|Baseline, Week 1, Week 4 and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.||score on a scale||Standard Deviation|Mean
32391|NCT01564537|Secondary|Pharmacokinetic Parameters (Including Cmax, AUC and Tmax) of Ixazomib||Days 1 & 14 of Cycles 1 & 2. Day 1 of Cycles 3 to 10||12/2020||||
32366|NCT01564862|Secondary|Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression|Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient*MADRS difference).|Baseline and Week 8|Full Analysis Set included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment.||proportion of direct effect|||Number
32367|NCT01564862|Secondary|Change From Baseline to Week 8 in the One-Back Task|The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Log 10 milliseconds||Standard Error|Least Squares Mean
32368|NCT01564862|Secondary|Change From Baseline to Week 8 in the Identification Task (IT)|The IT measured choice reaction time: the participant pressed a “yes” button whenever an onscreen playing card turned face up and was red, or a “no” button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Log10 milliseconds||Standard Error|Least Squares Mean
32369|NCT01564862|Secondary|Change From Baseline to Week 8 in the Detection Task (DT)|"The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a yes button as soon as an onscreen playing card is turned over and is red, and by pressing a no button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Log10 milliseconds||Standard Error|Least Squares Mean
32370|NCT01564862|Secondary|Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT)|"The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function.~An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||Errors||Standard Error|Least Squares Mean
32371|NCT01564862|Secondary|Change in Time From Baseline to Week 8 in the Stroop Test|The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||seconds||Standard Deviation|Mean
32372|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test B (TMT-B)|The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||seconds||Standard Error|Least Squares Mean
32387|NCT01563406|Secondary|Median Number of Microbial Colony Forming Units Per Hub Interior|This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.|15 months|||colony forming units (CFU) per hub|Participants|Inter-Quartile Range|Median
32388|NCT01563406|Secondary|Number of Contaminated Central Venous Catheter Tips|"This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as yes or no."|10 months|Unable to collect a sufficient number of catheter tips to analyze. Therefore, this outcome was dropped early in the study.|||||
32373|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test (TMT-A)|The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||seconds||Standard Error|Least Squares Mean
32374|NCT01564862|Secondary|Clinical Global Impressions-Improvement (CGI-I) Score at Week 8|"The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis."|Baseline, Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
32375|NCT01564862|Secondary|Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore|PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
32376|NCT01564862|Primary|Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)|The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Participants with scores of > 70 at Baseline were excluded.||Correct symbols||Standard Error|Least Squares Mean
32377|NCT01564758|Secondary|Number of Participants With Clinical Response|Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.|EOT (Day 10 up to 28)|Efficacy was evaluated for the safety analysis set which included all the participants who received at least 1 dose of study medication||participants|||Number
32378|NCT01564758|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to End of Treatment (EOT) (Day 10 up to 28)|Safety analysis set included all the participants who received at least 1 dose of study medication.||participants|||Number
32379|NCT01564732|Secondary|Quantitative Change in Hypertriglyceridemia|Triglyceride levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.|36 months|Data not collected.|||||
32380|NCT01564732|Secondary|Quantitative Change in Hyperlipidemia|Lipid levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.|36 months|Data not collected.|||||
32381|NCT01564732|Secondary|Quantitative Change in Diabetes|Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.|36 months|Data not collected|||||
32382|NCT01564732|Secondary|Quantitative Change in Hypertension|Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.|36 months|Data not collected.|||||
32383|NCT01564732|Secondary|Quality of Life||36 months|data not collected|||||
32384|NCT01564732|Primary|Weight Loss||36 months|Data not collected.|||||
32385|NCT01564706|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.|0-380 min after injection|||mSv/MBq||Standard Deviation|Mean
32392|NCT01564537|Secondary|PFS in High-Risk Participants|Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis.|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Participants from the ITT population, all randomized participants, with cytogenic abnormalities.||months||95% Confidence Interval|Median
32393|NCT01564537|Secondary|OS in High-Risk Participants|Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||12/2020||||
32394|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)|The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||12/2020||||
32395|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||12/2020||||
32396|NCT01564537|Secondary|Percentage of Participants Achieving Pain Response|Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity (“worst,” “least,” “average,” and “now” [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst).|At screening; Day 1 of each cycle; and thereafter every 4 weeks until disease progression||12/2020||||
32397|NCT01564537|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|From the date of signing of the informed consent form through 30 days after the last dose of study drug up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Safety population included all randomized participants who received at least 1 dose of ixazomib.||participants|||Number
32398|NCT01564537|Secondary|Time to Progression (TTP) as Assessed by the IRC|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants||months||95% Confidence Interval|Median
32399|NCT01564537|Secondary|Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment, all responders.||months||95% Confidence Interval|Median
32430|NCT01563536|Secondary|Percentage of Participants With Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) after 4 weeks of combination therapy.|4 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
32400|NCT01564537|Secondary|Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) as Assessed by the IRC|Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.||percentage of participants|||Number
32401|NCT01564537|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.||percentage of participants|||Number
32402|NCT01564537|Secondary|Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]|Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle (every 4 weeks) until disease progression and thereafter every 12 weeks until death or study termination||12/2020||||
32403|NCT01564537|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|Date of randomization until death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population was defined as all randomized participants.||months||95% Confidence Interval|Median
32404|NCT01564537|Primary|Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|"Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria.~PD requires 1 of the following:~Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed."|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Intent-to-Treat (ITT) population was defined as all randomized participants.||months||95% Confidence Interval|Median
32405|NCT01564459|Primary|Percentage of Participants Who Were Discontinued Form the Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.|up to 7 days for run-in; up to 14 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.||Percentage of Participants|||Number
32406|NCT01564459|Primary|Percentage of Participants Who Experienced 1 or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.|up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.||Percentage of Participants|||Number
32407|NCT01564459|Secondary|Change in Pain Intensity Scores - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant’s average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.||Score on a scale||95% Confidence Interval|Least Squares Mean
32408|NCT01564459|Secondary|Change in Pain Intensity Scores - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant’s average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the primary responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.||Score on a Scale||95% Confidence Interval|Least Squares Mean
32409|NCT01564459|Secondary|TTEF - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥20% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.||Days||95% Confidence Interval|Median
32410|NCT01564459|Primary|Time to Efficacy Failure (TTEF) - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.||Days||95% Confidence Interval|Median
32411|NCT01564394|Primary|FACIT-Fatigue Change From Baseline to 13-weeks.|Our primary outcome of change in fatigue was assessed with the Functional Assessment Chronic Illness Therapy (FACIT)-Fatigue scale. This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .||Units on scale||Inter-Quartile Range|Median
32412|NCT01564394|Primary|Attendance Rates in Study (Feasibility Outcome)|The class attendance rates were the number of classes attended by participants divided by the total number of classes offered. Range of attendance rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks|||Proportion of classes|||Number
32413|NCT01564394|Primary|Retention Rate in Study (Feasibility Outcome)|The retention rate was the proportion of participants who remained enrolled in the study and completed post-intervention measures. Range of retention rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks|||proportion of participants|||Number
32414|NCT01564394|Secondary|Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks|The BSI-18 assesses global distress and three subscales (anxiety, depression, & somatization). Scores are converted to T-scores based on US population norms. Negative change scores indicate improvement in distress. We report data separately for prostate cancer survivors and family members. Based on the population norm a T-score of 63 or above indicates heightened global distress.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .||T-Score||Inter-Quartile Range|Median
32415|NCT01563978|Secondary|DAS28-CRP Improvement|ANCOVA=analysis of covariance, BID=twice daily, DAS28-CRP=Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (C-reactive protein [CRP]) and the patient’s own assessment, FAS=full analysis set, IP=investigational product. Scores can take any positive value with a lower value indicative of a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicating a better clinical condition.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes those patients from the FAS who were still on IP at 4 weeks and had a valid measurement for this type of assessment.||Units on a scale||Standard Deviation|Mean
32416|NCT01563978|Secondary|Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP|BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|Day 29 to Day 36|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes patients from the FAS still on IP at Day 36 and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32417|NCT01563978|Secondary|Mean Change From Baseline in Evening Post-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32418|NCT01563978|Secondary|Mean Change From Baseline in Morning Pre-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32419|NCT01563978|Secondary|Mean Change From Baseline in Clinic SBP and DBP|Blood pressure was measured in the clinic using an automated blood pressure machine (oscillometric method). Three separate measurements were taken 2 to 5 minutes apart and the mean of the 2nd and 3rd measurements calculated. ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32420|NCT01563978|Secondary|Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32421|NCT01563978|Secondary|Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32422|NCT01563978|Secondary|Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32423|NCT01563978|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and had a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32424|NCT01563978|Primary|Change From Baseline in 24-hour Mean Ambulatory SBP|ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.||mmHg||Standard Deviation|Mean
32425|NCT01563536|Other Pre-specified|Resistance-Associated Variants and Phenotypic Resistance|Baseline (pre-dose on Day 1) samples were analyzed for resistance-associated amino acid (AA) variants using population sequencing. Phenotypic resistance to ABT-267 at Baseline was assessed by calculating the fold difference in the the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Day 3 samples were analyzed using population sequencing and were compared with the baseline and appropriate prototypic reference sequences to assess AA changes. Phenotypic resistance at Day 3 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding Baseline sample. The number of participants with variants at resistance-associated AA positions and phenotypic resistance at Baseline and Day 3 are presented.|Day 1 Pre-dose (Baseline) and Day 3 Pre-dose|All participants who received at least one dose of study drug (ITT population) and had evaluable data were analyzed for baseline resistance-associated amino acid variants; the development of viral resistance was analyzed in all participants who received at least 1 dose of ABT-267 whose samples had sufficient viral titer to allow analysis.||participants|||Number
32426|NCT01563536|Primary|Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy|The baseline value was the last measurement before the first dose of ABT-267 monotherapy (Day 1). The maximal decrease during monotherapy was the change from baseline to the lowest log10 IU/mL HCV RNA level any time from the first dose of ABT-267 on Day 1 to the last log10 HCV RNA level before the first dose of ABT-267 combination therapy (Study Day 3).|Pre-dose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).||log10 IU/mL||Standard Error|Least Squares Mean
32427|NCT01563536|Secondary|Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy|The relationship between ABT-267 dose, ABT-267 concentration, and response was analyzed as the change in viral load (measured as log10 IU/mL) from baseline (pre-dose on Day 1) to pre-dose on Days 2 and 3. Plasma concentrations of ABT-267 pre-dose on Days 2 and 3 are presented above in 4. Primary Outcome: Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3.|Predose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).||log10 IU/mL||Standard Deviation|Mean
32428|NCT01563536|Secondary|Percentage of Participants With Extended Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at Weeks 4 through 12 of combination therapy.|Weeks 4 to 12|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
32429|NCT01563536|Secondary|Percentage of Participants With End-of-Treatment Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at the end of combination therapy (12 weeks).|12 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
32431|NCT01563536|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 and 24 weeks after the last dose of combination study drug. The LLOQ for the assay was 25 IU/mL.|12 and 24 weeks after last dose of combination study drug|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.||percentage of participants|||Number
32432|NCT01563536|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs), and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks).|All participants who received at least one dose of study drug (safety population).||participants|||Number
32433|NCT01563536|Primary|Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3|Blood samples were collected pre-dose on Day 2 (prior to second dose of ABT-267 monotherapy) and pre-dose on Day 3 (prior to first dose of combination therapy). The samples were analyzed for ABT-267 using validated analytical methods. Pre-dose plasma concentrations on Day 2 and Day 3 (Ctrough, measured in ng/mL) are reported.|Day 2 (pre-dose) and Day 3 (pre-dose)|All participants who received at least one dose of study drug (ITT population).||ng/mL||Standard Deviation|Mean
32434|NCT01563536|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[24]; measured in ng multiplied by hour/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).||ng*hr/mL||Standard Deviation|Mean
32435|NCT01563536|Primary|Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Time of maximum plasma concentration (Tmax; measured in hours) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).||hours||Standard Deviation|Mean
32436|NCT01563536|Primary|Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (intent-to-treat [ITT] population).||ng/mL||Standard Deviation|Mean
32437|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Volume Distribution (V/F)|V/F were estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group|||L/70 kg||Standard Deviation|Mean
32438|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Individual Oral Clearance (CL/F)|CL/F was estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable and all 9 were in the multiple dose pharmacokinetic group).||L/h/70 kg||Standard Deviation|Mean
32439|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUC(0-t))|AUC(0-t) was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average AUC values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 patient was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).||ug*h/mL||Standard Deviation|Mean
32440|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Maximum Observed Concentration (Cmax)|Cmax was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average Cmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).||ug/mL||Standard Deviation|Mean
32441|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Time of Maximum Observed Concentration (Tmax)|Tmax was estimated for ibuprofen and famotidine.The PK parameters for ibuprofen and famotidine represent average Tmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).||hours||Standard Deviation|Mean
32442|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Serum C Reactive Protein (CRP) Concentration|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CRP Concentration. This ACR value represents the average change in Serum C Reactive Protein (CRP) Concentration from the baseline visit to the week 24/ET visit. The normal range referenced was 0 mg/L - 4.99 mg/L.|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||mg/L||Standard Error|Mean
32443|NCT01563185|Secondary|ACR Pediatric Components by Time Point: Number of Joints With Active Arthritis and the Number of Joints With Limited Range of Motion Number of Joints With Active Arthritis|"The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: number of joints with active arthritis and the number of joints with limited range of motion. These ACR values represent the average change in number of joints with active arthritis and the number of joints with limited range of motion from the baseline visit to the week 24/ET visit.~The joints that were assessed include the right and left temporomandibular, sternoclavicular, arcomiclavicular, shoulder, elbow, wrist, MCP - 1. MCP - 2, MCP - 3, MCP - 4, MCP - 5, PIP - 1, PIP - 2, PIP - 3, PIP - 4, PIP - 5, DIP - 1, DIP - 2, DIP - 3, DIP - 4, and DIP - 5."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||Number of joints||Standard Error|Mean
32444|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: CHAQ - Disability Index|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CHAQ - Disability Index. This ACR measurement represents the average change in the Childhood Health Assessment Questionnaire (CHAQ) - Disability Index from the baseline visit to the week 24/ET visit. The CHAQ disability index is measured on a scale of 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||units on a scale||Standard Error|Mean
32445|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Physician's Global Assessment of Disease Activity and Parent's Assessment of Overall Well-being|The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: the physician's global assessment of disease activity and the parent's global assessment of overall well-being. These ACR values represent the average change in the physician's global assessment of disease activity and the parent's global assessment of overall well-being from the baseline visit to the week 24/ET visit. The ACR pediatric core measure: Physician's global assessment of disease activity and parent's assessment of overall well being was measured on a scale of 0-100 mm (0 = very good, 100=very poor).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||units on a scale||Standard Error|Mean
32446|NCT01563185|Secondary|Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores|"To assess patient quality of life while on study medication, the CHQ was administered to the patients' parent or guardian on Day 0 and at the Week 24/ET visit. The raw scale scores were transformed into scores on a 0 to 100 scale, 100 indicating best health and 0 indicating worst health. The algorithm is:~Transformed Score = ((Actual Raw Score - Lowest Possible Raw Score)/(Possible Raw Score Range)) x100. The actual raw score is the mean of the item responses in a scale (sum of item responses/number of completed items). The possible raw score range is the highest possible raw score minus the lowest possible raw score. The outcome measure data table shows the average change in the CHQ concepts from Baseline to the week 24 visit. The average change in the CHQ concepts is on a -100 to 100 scale, -100 representing a negative change in health and 100 indicating a positive change in health."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).|||units on a scale||Standard Deviation|Mean
32447|NCT01563185|Primary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs)|Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.|Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)|||participants|||Number
32448|NCT01563081|Secondary|Cmax and Cmin of Levocetirizine in Plasma|Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the >=6 months and <12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the >=12 months and <24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa.|Weeks 1 and 2/Early Withdrawal|Pharmacokinetic Concentration Population: all participants who underwent blood sampling, who provided data at the time of the last dose and the time of blood sampling, and who provided valid drug concentrations||nanograms per milliliter||Full Range|Median
32449|NCT01563081|Secondary|Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal|The investigator comprehensively assessed the pariticipant’s severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none.|First day of treatment; Weeks 1 and 2/Early Withdrawal|FAS. Only those participants with pruritis associated with skin diseases at Baseline were assessed for pruritis severity.||participants|||Number
32565|NCT01562327|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least one of the conditions.|Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
32450|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator|The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened.|First day of treatment; Weeks 1 and 2/Early Withdrawal|"FAS. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2/Early Withdrawal. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."||participants|||Number
32451|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression|"The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."|First day of treatment; Weeks 1 and 2/Early Withdrawal|Full Analysis Set (FAS): all participants, excluding those with any major good clinical practice deviation, those who did not meet the primary criteria for enrollment, those who received no dose of study medication, and those with no data after supply of the investigational product||participants|||Number
32452|NCT01563081|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)|A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of >=5%, please see the SAE/non-serious AE module of this record.|up to Week 2/Early Withdrawal (EW)|Safety Population : all participants who participated in this study and who received at least one dose of medication||participants|||Number
32453|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
32454|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
32455|NCT01563055|Secondary|Cmax/D for Phenyl Acetic Acid Mustard|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL/mg||95% Confidence Interval|Geometric Mean
32456|NCT01563055|Secondary|Dose Normalized Cmax (Cmax/D) for Chlorambucil|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL/mg||95% Confidence Interval|Geometric Mean
32457|NCT01563055|Secondary|AUC (0-t) of Phenyl Acetic Acid Mustard|AUC (0-t) represents the area under the concentration curve of phenyl acetic acid mustard in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL||95% Confidence Interval|Geometric Mean
32566|NCT01562327|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||6 months after treatment initiation|The Full Analysis Set (FAS) was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants||95% Confidence Interval|Number
32458|NCT01563055|Secondary|AUC (0-t) of Chlorambucil|AUC (0-t) represents the area under the concentration curve of chlorambucil in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*ng/mL||95% Confidence Interval|Geometric Mean
32459|NCT01563055|Secondary|AUC (0-t) of Ofatumumab|AUC (0-t) represents the area under the concentration curve of ofatumumab in plasma from 0 to time t hours. AUC (0-t) was assessed at 168 hours and 672 hours post-dose.|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hr*µg/mL||95% Confidence Interval|Geometric Mean
32460|NCT01563055|Secondary|%AUC_extrap of Phenyl Acetic Acid Mustard|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
32461|NCT01563055|Secondary|%AUC_extrap of Chlorambucil|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
32462|NCT01563055|Secondary|%AUC_extrap of Ofatumumab|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
32463|NCT01563055|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil|Vz/F of chlorambucil is defined as the apparent volume of distribution during terminal phase after non-intravenous (oral) administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||L/m^2||95% Confidence Interval|Geometric Mean
32464|NCT01563055|Secondary|Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil|CL/F is defined as the apparent total clearance of the drug from plasma after oral administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||L/hr/m^2||95% Confidence Interval|Geometric Mean
32465|NCT01563055|Secondary|Volume of Distribution (Vz) of Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||mL||95% Confidence Interval|Geometric Mean
32466|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard|MRTinf is the average amount of time that phenyl acetic acid mustard spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
32467|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Chlorambucil|MRTinf is the average amount of time that chlorambucil spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
32468|NCT01563055|Secondary|Mean Residence Time to Infinity (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||hours||95% Confidence Interval|Geometric Mean
32582|NCT01562314|Secondary|Plasma Endocannabinoid Levels - Oleoylethanolamide (OEA)|Change from baseline in the endocannabinoid OEA|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
32469|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
32470|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Chlorambucil|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
32471|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Ofatumumab|Tmax is the time required for reaching maximum concentration of drug (Cmax). Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
32472|NCT01563055|Secondary|Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard|t1/2 is the time required for the plasma/serum concentration of phenylacetic acid mustard to decrease by half. Blood samples for serum concentration of phenylacetic acid mustard was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population||hours||95% Confidence Interval|Geometric Mean
32473|NCT01563055|Secondary|Plasma Half-life (t1/2) of Chlorambucil|t1/2 is the time required for the serum concentration of chlorambucil to decrease by half. Blood samples for serum concentration of chlorambucil was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
32474|NCT01563055|Secondary|Plasma Half-life (t1/2) of Ofatumumab|t1/2 is the time required for the plasma concentration of ofatumumab to decrease by half. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||95% Confidence Interval|Geometric Mean
32475|NCT01563055|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||mL||95% Confidence Interval|Geometric Mean
32476|NCT01563055|Secondary|AUC(0-infinity) for Phenyl Acetic Acid Mustard|The total AUC or AUC(0-infinity) is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
32477|NCT01563055|Secondary|AUC(0-infinity) for Chlorambucil|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
32478|NCT01563055|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed on Cycle 1-Day 1. The samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||Hr*ug/mL||95% Confidence Interval|Geometric Mean
32488|NCT01563055|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Maximum (peak) plasma drug concentration of ofatumumab was determined at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
32479|NCT01563055|Secondary|AUC(0-tau) of Phenyl Acetic Acid Mustard|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
32480|NCT01563055|Secondary|AUC(0-tau) of Chlorambucil|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hr*ng/mL||95% Confidence Interval|Geometric Mean
32481|NCT01563055|Secondary|Area Under the Drug Plasma Concentration-time Curve From Dosing to Time Tau (AUC[0-tau]) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. For ofatumumab it was assesed at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Hours*nanogram/milliliter (hr*ng/mL||95% Confidence Interval|Geometric Mean
32482|NCT01563055|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population||Milliliters/hour (mL/hr)||95% Confidence Interval|Geometric Mean
32483|NCT01563055|Secondary|Cmin of Phenyl Acetic Acid Mustard|Cmin of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Geometric Mean
32484|NCT01563055|Secondary|Cmin of Chlorambucil|Cmin of chlorambucil was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Mean
32485|NCT01563055|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Minimum plasma drug concentration of ofatumumab was determined at Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), Cycle 2-Day 29 (pre-dose), Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr), Cycle 4-Day 85 (pre-dose, 30 min post end of infusion), Cycle 5-Day 113 (pre-dose and end of infusion) and Cycle 6-Day 141 (pre-dose and end of infusion).|Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
32486|NCT01563055|Secondary|Cmax of Serum Phenyl Acetic Acid Mustard|Cmax of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Geometric Mean
32487|NCT01563055|Secondary|Cmax of Serum Chlorambucil|Cmax of serum chlorambucil was assesed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.||ng/mL||95% Confidence Interval|Geometric Mean
32583|NCT01562314|Secondary|Plasma Endocannabinoid Levels - Anandamide (AEA)|Change from baseline in the endocannabinoid AEA|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
32489|NCT01563055|Secondary|Complement (CH50) at Cycle 1-Day 1 and Cycle 4-Day 85|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation. Peripheral blood samples were collected for analysis at Cycle 1-Day 1 and Cycle 4-Day 85.|Cycle 1-Day 1 and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects pPopulation.||Kilo units per liter (KU/L)||Standard Deviation|Mean
32490|NCT01563055|Secondary|Beta-2 Microglobulin at Cycle 1-Day 1|Beta-2-microglobulin is a protein present on the surface of most cells. Higher levels indicate a poor prognosis of CLL. Beta-2 microglobulin was measured at Cycle 1-Day 1.|Cycle 1-Day 1|All Subjects Population||Nanomoles per liter (NMOL/L)||Standard Deviation|Mean
32491|NCT01563055|Secondary|Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted in peripheral blood by flow cytometry. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. B-cell monitoring (CD5+CD19+ and CD5-CD19+) was performed at Cycle 1 (Day 1, Day 15) and Cycle 2 (Day 29, Day 43), on Day 1 of Cycle 3, 4, 5, 6, 9 and 12 (Day 57, Day 85, Day 113, Day 141, Day 225, Day 309), 28 days after the first day of the last treatment cycle (FU 1-PDFU 1) for all participants depending on the number of cycles administered, and 84 and 168 days after the day of FU 1-PDFU 1 for participants in CR, PR, and SD.|Baseline, C1-D15, C2-D29, C2-D43, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.||Cells per microliter||Standard Deviation|Mean
32492|NCT01563055|Secondary|Number of Participants Who Were Positive or Negative for Minimal Residual Disease (MRD), as Assessed by IRC With CT|MRD refers to small number of leukemic cells that remain in the participant's body during treatment or after treatment in participants who achieved a confirmed complete remission. MRD assessment in bone marrow aspiration sample was perfrmed by flow cytometry (cluster of differentiation [CD]5, CD19, CD20, CD23). The absence of MRD was defined as less than one CLL cell per 10,000 leukocytes. The number of participants who were positive and negative for MRD are presented.|FU 85-PDFU 85 (84 days after FU-1)|All Subjects Population. Only those participants who were positive and negative for MRD were analyzed.||Participants|||Number
32493|NCT01563055|Secondary|Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Immunoglobulins were measured at Cycle 1-Day 1, FU 1-PDFU 1, and FU 169-PDFU 169 for participants in CR, PR, and stable disease (SD).|Baseline (Cycle 1-Day 1), FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.||Grams per liter||Standard Deviation|Mean
32494|NCT01563055|Secondary|Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points|HAHA are indicators of immunogenicity induced by ofatumumab. Blood samples were taken from participants at Screening, Cycle 4-Day 85, FU 1-PDFU 1, and FU 169-PDFU 169. The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. The results are presented as participants with HAHA results as positive, negative or confirmation required.|Screening, Cycle 4-Day 85, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
32495|NCT01563055|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events|"Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Participants with Grade (G)3 or G4 adverse event of infection and myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Also presented are number of participants with autoimmune hemolytic anemia (AIHA). AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells."|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population||Participants|||Number
32496|NCT01563055|Secondary|Number of Participants With AEs of Maximum Severity|Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population||Participants|||Number
32538|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
32497|NCT01563055|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population||Participants|||Number
32498|NCT01563055|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from Baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was the last pre-dose assessment performed on Cycle 1-Day 1(C1-D1). When C1-D1 was missing, the last assessment performed prior to pre-dose C1-D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.||Participants|||Number
32499|NCT01563055|Secondary|Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points|The number of participants with no B-symptoms (no night sweat [without signs of infection], no unexplained, unintentional weight loss >= 10% within the previous 6 months, no recurrent, unexplained fever of greater than 38 degrees celcius for 2 weeks and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at Cycle (C) 1-Day (D) 1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
32500|NCT01563055|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From start of treatment until the first administration of the next CLL therapy (up to Week 62.3)|All Subjects Population. Only those participants who received next CLL therapy were evaluated.||Weeks||95% Confidence Interval|Median
32501|NCT01563055|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the first documented evidence of CR, CRi, nPR or PR until the first documented sign of PD or death in participants with CR, CRi, nPR or PR. For participants who did not progress or die, duration of response was censored on the date of last assessment.|From initial response (CR/CRi/nPR/PR) until disease progression or death (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.||Weeks||95% Confidence Interval|Median
32502|NCT01563055|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from start of treatment until the first response (CR/CRi/nPR/PR). Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. This analysis only included participants who had a response while in the study, there was no censoring.|From start of treatment until the first response (CR/CRi/nPR/PR) (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.||Weeks||95% Confidence Interval|Median
32503|NCT01563055|Secondary|Overall Survival|Overall survival is defined as time from start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of the last date of contact.|From start of treatment until death (up to Week 62.3|All Subjects Population||Weeks||95% Confidence Interval|Median
32504|NCT01563055|Secondary|Progression-free Survival (PFS), as Assessed by the IRC and the Investigator|Progression free survival is defined as the time from start of treatment until disease progression (PD) or death due to any cause. PD was determined by the IRC or investigator according to the definitions of response in the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 per microliter B-lymphocytes; transformation to a more aggressive histology; or occurrence of cytopenia attributable to chronic lymphocytic leukemia. PFS was censored at the last visit with adequate assessment for participants who were alive and had not progressed.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population. Only participants who progressed or died were analyzed.||Weeks||95% Confidence Interval|Median
32561|NCT01562327|Secondary|Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||participants|||Number
32505|NCT01563055|Secondary|Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, CR (all the criteria at least 2 months after last treatment): peripheral blood lymphocytes below < 4,000/μL, no Ly > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; Neu >1500 /µL, PL >100,000/µL, Hb >11 g/dL, BM sample must be normocellular for age, <30% lymphocytes, no LN. PR: >=50% decrease in peripheral blood lymphocytes, Ly, size of liver and spleen; and blood count showing at least one of the following results: Neu>1500/μL, PL >100,000/µL or 50% improvement over BL, Hb >11 g/dL or 50% improvement over BL. No increase in LN and no new LN.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population||Participants|||Number
32506|NCT01563055|Primary|Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator|Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (>=2 months after last treatment): lymphocytes (LC) <4000 per microliter (μL), no lymphadenopathy (Ly)>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)>1500/µL, platelets (PL)>100,000/µL, hemoglobin (Hb)>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,<30% LC, no lymphoid nodule (LN). PR:>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N>1500/μL, PL>100,000/µL or 50% improvement over Baseline (BL), Hb>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population||Participants|||Number
32507|NCT01563055|Primary|Number of Participants Who Developed Toxicity Requiring Discontinuation From Study Treatment During Cycle 1|Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or <=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.|From start of treatment through Cycle 1 (Week 4)|All Subjects Population: all participants who received at least one dose of investigational product.||Participants|||Number
32508|NCT01563029|Secondary|Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period|The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.|Up to Week 12|ITT Population||Participants|||Number
32509|NCT01563029|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the percentage of symptom free 24-hr periods in the last 7 days of the run-in period. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment group.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
32510|NCT01563029|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
32511|NCT01563029|Secondary|Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
32512|NCT01563029|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.||liters per minute (L/min)||Standard Error|Least Squares Mean
32513|NCT01563029|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. The Baseline rescue-free value was defined as the percentage of rescue-free 24-hr periods from the last 7 days of the Run-in Period. Change from Baseline was calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
32514|NCT01563029|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, actual pre-screening ICS use, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements. Only those participants available at the specified time points were analyzed.|Baseline, Week 12|ITT Population. Only participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
32515|NCT01563029|Primary|Change From Baseline in Daily Pre-dose Morning (AM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, actual pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population: participants randomized to treatment who received at least 1 dose of study medication. Only participants available at the specified time points were analyzed.||Liters per minute (L/min)||Standard Deviation|Least Squares Mean
32516|NCT01563003|Secondary|Clinical Global Impression - Severity Scale|Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
32517|NCT01563003|Secondary|Anxiety Disorders Interview Schedule Clinical Severity Rating|Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
32518|NCT01563003|Primary|Pediatric Anxiety Rating Scale|Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
32519|NCT01562886|Secondary|Number of Subjects With HIV Viral Load Above 50 Copies Per mL|Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL)|Day 3,14, 28, 60, 80-100|||participants|||Number
32520|NCT01562886|Primary|CSF:Plasma Ratio of Rilpivirine Levels|The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure|Day 60|||ratio expressed as a percentage||95% Confidence Interval|Geometric Mean
32521|NCT01562743|Secondary|Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit|SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, Up to 53 weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
32522|NCT01562743|Primary|Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit|PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement.|Baseline, Up to 53 weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
32523|NCT01562743|Secondary|Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit|"ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24).~A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 52 weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
32524|NCT01562743|Secondary|Efficacy Rate in IRLS Sum Score|Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.|Baseline, Up to 53 weeks|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
32525|NCT01562743|Secondary|Change of IRLS Sum Score From the Baseline to Each Visit|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, Up to 53 weeks|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
32562|NCT01562327|Secondary|Reason for DMARDs Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.||participants|||Number
32526|NCT01562743|Primary|Augmentation|"Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity.~Augmentation is clinically significant when at least one of the following occurs:~Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;~Negative impact on the patient’s quality of life (sleep, mood, etc.) due to augmentation;~Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose);~Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity);~Any other aspect as judged by the evaluator (should be specified)."|Up to 53 weeks|SS||participants|||Number
32527|NCT01562743|Primary|The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters.~AEs of special interest (1-3) are defined as below:~sudden onset of sleep~obsessive-compulsive disorder or impulse-control disorder~hallucination, delusion"|Up to 54 weeks|Safety set (SS)||participants|||Number
32528|NCT01562613|Secondary|Change in Framingham Stroke Risk Profile Scores of the Participating Patients|"The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke.~First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D’Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D’Agostino et al.~The score can range from 0-38 (according to the scales of D’ Agostino et al) with higher scores yielding increased 10-year probability of stroke."|Baseline up to 6 months|"Excluded from Framingham calculation were patients with either~a history of cerebrovascular accident~any of the parameters missing for the calculation of the Framingham~age <54 years or > 84 years for females & <54 or > 85 years for males"||score on a scale||Full Range|Median
32529|NCT01562613|Primary|The Absolute Change in Systolic Blood Pressure From Baseline|The absolute change in systolic Blood Pressure from baseline|Baseline up to 6 months|||mmHg||Standard Deviation|Mean
32530|NCT01562613|Primary|The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions.|"The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions.~Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of <140 mmHg/90 mmHg [systolic BP (SBP)/diastolic BP (DBP)] for the general population of hypertensive patients OR of <130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions [stroke, myocardial infarction, coronary artery disease (CAD)]"|Baseline up to 6 months|||Percentage of participants||95% Confidence Interval|Number
32531|NCT01562548|Secondary|Global Assessment of Headache Intensity (GAHI)|Categorized after treatment as: ‘decreased’, ‘increased’ or ‘stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||participants|||Number
32532|NCT01562548|Secondary|Global Assessment of Headache Frequency (GAHF)|Categorized after treatment as: ‘decreased’, ‘increased’ or ‘stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||participants|||Number
32533|NCT01562548|Secondary|Global Assessment of Sleep Disturbance (GASD)|Categorized after treatment as: ‘decreased’, ‘increased’ or 'stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||participants|||Number
32534|NCT01562548|Secondary|Global Assessment of Treatment Helpfulness (GATH)|Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
32535|NCT01562548|Secondary|Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores|Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst.|Before treatment, 4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
32536|NCT01562548|Secondary|Muscle Relaxation Scores|The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
32537|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
32539|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
32540|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who receive at least one dose of study medication and who had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
32541|NCT01562548|Primary|Mean Change From Baseline of Both AM and PM Spasm Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.|7 Days|Efficacy analysis was conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. Subjects were analyzed according to the treatment to which they were randomized.||Score on a Scale||Standard Deviation|Mean
32542|NCT01562327|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.|approximately 3 years|Safety population was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
32543|NCT01562327|Secondary|Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
32544|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6|The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
32545|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6|The Patient Global Assessment of fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
32546|NCT01562327|Secondary|Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.||percentage of participants|||Number
32547|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
32548|NCT01562327|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.||units on a scale||Full Range|Median
32563|NCT01562327|Secondary|Percentage of Participants Who Previously Received DMARDs||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
32564|NCT01562327|Secondary|Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||participants|||Number
32584|NCT01562314|Secondary|Plasma Endocannabinoid Levels - 2-arachidonoyl Glycerol (2-AG)|Change from baseline in the endocannabinoid 2-AG|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
32549|NCT01562327|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.||percentage of participants|||Number
32550|NCT01562327|Secondary|European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant’s disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Month 3, Month 6|Data was not collected, hence not reported.|||||
32551|NCT01562327|Secondary|Simplified Disease Activity (SDAI) Response Classification|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.|Month 3, Month 6|Data was not collected, hence not reported.|||||
32552|NCT01562327|Secondary|Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6|CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.||participants|||Number
32553|NCT01562327|Secondary|Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.||participants|||Number
32554|NCT01562327|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A decrease in score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Full Range|Median
32555|NCT01562327|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A decrease in score indicated improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.||units on a scale||Full Range|Median
32556|NCT01562327|Secondary|Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy|Percentage of participants on Tocilizumab as monotherapy or combination therapy (with DMARDs) were reported at start of treatment and at 6 months from the start of treatment.|Baseline, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
32557|NCT01562327|Secondary|Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy||Approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
32558|NCT01562327|Secondary|Reasons for Dose Modifications||approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.||participants|||Number
32559|NCT01562327|Secondary|Reason for Biologic Agent Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.||participants|||Number
32560|NCT01562327|Secondary|Percentage of Participants Who Previously Received Biologic Agents||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.||percentage of participants|||Number
32567|NCT01562314|Post-Hoc|Mayo Partial Score - PP Analysis Set|"Change in Mayo partial score from Baseline to Final Visit.~The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).~The Mayo partial score does not include the endoscopy findings sub-score, and is calculated by summing the remaining three sub-scores (stool frequency, rectal bleeding and PGAS) to give a value ranging from 0-9 points. As with the Mayo total score, higher Mayo partial scores indicate more severe disease."|Baseline to end of treatment (10 weeks treatment period)|PP Analysis Set||Points on a scale||Standard Deviation|Mean
32568|NCT01562314|Secondary|Clinical Body Weight Assessment|Change in body weight from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Kg||Standard Deviation|Mean
32569|NCT01562314|Primary|Percentage of Participants Achieving Remission Quantified as a Mayo Score of 2 or Less (With no Sub-score >1) - PP Analysis Set|The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).|Baseline to end of treatment (10 weeks treatment period)|Per protocol (PP) analysis set||percentage of participants|||Number
32570|NCT01562314|Post-Hoc|Mayo Score: Responder Analysis - PP Analysis|"Proportion of participants responding between Baseline and Final Visit.~The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).~A responder was defined as a participant with a decrease in their Mayo total score of ≥3 points, compared to baseline, with a reduction of at least 1 point in endoscopy findings sub-score."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||% of participants|||Number
32571|NCT01562314|Post-Hoc|Mayo Total Score - PP Analysis|"Change in Mayo total score from Baseline to Final Visit.~The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
32572|NCT01562314|Post-Hoc|Ulcerative Colitis Symptom Measures - Pain - PP Analysis|"Change in Pain from Baseline to end of treatment.~Pain scores using a 0-10 numerical rate scale (0 = no pain; 10 = pain as bad as you can imagine) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean pain score of the last seven available days of the baseline period; the end of treatment value is defined as the mean pain score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
32573|NCT01562314|Post-Hoc|Clinical Efficacy Stool Sample Measurements - PP Analysis|Change in faecal inflammatory marker calprotectin from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||ug/g||Standard Deviation|Mean
32574|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - TNF - PP Analysis|Change in serum cytokine TNF-alpha from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||pg/mL||Standard Deviation|Mean
32575|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - IL-6 - PP Analysis|Change in serum cytokine IL-6 from Baseline to Final Visit.|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||ng/L||Standard Deviation|Mean
32576|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - IL-2 - PP Analysis|Change in serum cytokine IL-2 from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||ng/L||Standard Deviation|Mean
32577|NCT01562314|Post-Hoc|Clinical Efficacy Blood Sample Measurements - CRP - PP Analysis|Change in serum CRP from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||mg/L||Standard Deviation|Mean
32578|NCT01562314|Secondary|Mayo Score: Responder Analysis|"Proportion of participants responding between Baseline and Final Visit~The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).~A responder was defined as a participant with a decrease in their Mayo total score of ≥3 points, compared to baseline, with a reduction of at least 1 point in endoscopy findings sub-score."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||% of participants|||Number
32579|NCT01562314|Secondary|Mayo Partial Score|"Change in Mayo partial score from Baseline to Final Visit.~The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).~The Mayo partial score does not include the endoscopy findings sub-score, and is calculated by summing the remaining three sub-scores (stool frequency, rectal bleeding and PGAS) to give a value ranging from 0-9 points. As with the Mayo total score, higher Mayo partial scores indicate more severe disease."|Baseline to end of treatment (10 weeks treatment period)|ITT Analysis Set||Points on a scale||Standard Deviation|Mean
32580|NCT01562314|Secondary|Mayo Total Score|"Change in Total Mayo score from Baseline to Final Visit.~The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
32581|NCT01562314|Secondary|Plasma Endocannabinoid Levels - PEA|Change from baseline in the endocannabinoid PEA|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||nmol/L||Standard Deviation|Mean
32585|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Rectal Bleeding - PP Analysis|"Change in rectal bleeding from Baseline to end of treatment.~Rectal bleeding scores using a 0-4 numerical rate scale (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time or more; 3 = Blood alone passes) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean rectal bleeding score of the last seven available days of the baseline period; the end of treatment value is defined as the mean rectal bleeding score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
32586|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Rectal Bleeding|"Change in rectal bleeding from Baseline to end of treatment.~Rectal bleeding scores using a 0-4 numerical rate scale (0 = No blood seen; 1 = Streaks of blood with stool less than half the time; 2 = Obvious blood with stool most of the time or more; 3 = Blood alone passes) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean rectal bleeding score of the last seven available days of the baseline period; the end of treatment value is defined as the mean rectal bleeding score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
32587|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Stool Frequency - PP Analysis|"Change in stool frequency from Baseline to end of treatment.~Stool frequency scores using a 0-4 numerical rate scale (0 = Normal number of stools; 1 = 1-2 stools more than normal; 2 = 3-4 stools more than normal; 3 = 5 or more stools more than normal) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean stool frequency score of the last seven available days of the baseline period; the end of treatment value is defined as the mean stool frequency score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
32588|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Stool Frequency|"Change in stool frequency from Baseline to end of treatment.~Stool frequency scores using a 0-4 numerical rate scale (0 = Normal number of stools; 1 = 1-2 stools more than normal; 2 = 3-4 stools more than normal; 3 = 5 or more stools more than normal) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean stool frequency score of the last seven available days of the baseline period; the end of treatment value is defined as the mean stool frequency score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
32589|NCT01562314|Secondary|Ulcerative Colitis Symptom Measures - Pain|"Change in Pain from Baseline to end of treatment.~Pain scores using a 0-10 numerical rate scale (0 = no pain; 10 = pain as bad as you can imagine) were recorded in daily diaries, by participants, during the baseline and treatment periods. For analysis the baseline value is defined as the mean pain score of the last seven available days of the baseline period; the end of treatment value is defined as the mean pain score of last seven days of the treatment period."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
32590|NCT01562314|Secondary|Clinical Assessments - PGAS - PP Analysis|"Change in PGAS from Baseline to Final Visit.~The PGAS required the physician to assess participants' disease severity on a four point scale (0=normal, 1=mild disease, 2=moderate disease, 3=severe disease)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
32591|NCT01562314|Secondary|Clinical Assessments - Physician's Global Assessment of Illness Severity (PGAS)|"Change in PGAS from Baseline to Final Visit.~The PGAS required the physician to assess participants’ disease severity on a four point scale (0=normal, 1=mild disease, 2=moderate disease, 3=severe disease)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Deviation|Mean
32592|NCT01562314|Secondary|Clinical Assessments - SGIC - PP Analysis|"SGIC - percentage of participants showing improvement at Final Visit.~Participants were asked to assess the status of their ulcerative colitis since study entry using a seven-point scale (very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||% of participants|||Number
32593|NCT01562314|Secondary|Clinical Assessments - Subject Global Impression of Change (SGIC)|"SGIC - percentage of participants reporting improvement at Final Visit.~Participants were asked to assess the status of their ulcerative colitis since study entry using a seven-point scale (very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||% of participants|||Number
32594|NCT01562314|Secondary|Clinical Assessments - IBDQ - PP Analysis|"Change in IBDQ total score from Baseline to Final Visit.~The IBDQ is a validated and reliable tool to measure health-related quality of life in adult patients with inflammatory bowel disease. Each of the 32 questions falls into one of four domains (bowel symptoms, systemic symptoms, emotional status and social functioning). All questions were scored out of seven, with higher scores attributed to increasingly favourable responses; accordingly, any increase in score signified an improvement in condition. Individual question scores were summed to give the IBDQ total score (range: 32-224 points)."|Baseline to end of treatment (10 weeks treatment period)|PP analysis set||Points on a scale||Standard Deviation|Mean
32595|NCT01562314|Secondary|Clinical Assessments - Inflammatory Bowel Disease Questionnaire (IBDQ)|"Change in IBDQ total score from Baseline to Final Visit.~The IBDQ is a validated and reliable tool to measure health-related quality of life in adult patients with inflammatory bowel disease. Each of the 32 questions falls into one of four domains (bowel symptoms, systemic symptoms, emotional status and social functioning). All questions were scored out of seven, with higher scores attributed to increasingly favourable responses; accordingly, any increase in score signified an improvement in condition. Individual question scores were summed to give the IBDQ total score (range: 32-224 points)."|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||Points on a scale||Standard Error|Mean
32596|NCT01562314|Secondary|Clinical Efficacy Stool Sample Measurements|Change in faecal inflammatory marker calprotectin from Baseline to Final Visit|Baseline to end of treatment (10 weeks treatment period)|ITT analysis set||ug/g||Standard Deviation|Mean
32601|NCT01562314|Primary|Percentage of Participants Achieving Remission, Quantified as a Mayo Score of 2 or Less (With no Sub-score >1).|The Mayo score is an assessment of ulcerative colitis activity, with higher scores indicating more severe disease. The Mayo total score (range 0-12 points) is made up of four sub-scores (stool frequency, rectal bleeding, endoscopy findings and the physicians assessment of illness severity); each carrying equal numerical weight (0-3 points).|Baseline to end of treatment (10 weeks treatment period)|Intention to treat (ITT) analysis set||percentage of participants|||Number
32602|NCT01562275|Secondary|Progression-Free Survival (PFS) Time for Participants With Measurable Disease According to RECIST v1.1|PFS is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.|||||
32603|NCT01562275|Secondary|Duration of Objective Response for Participants With Measurable Disease According to RECIST v1.1|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.|||||
32604|NCT01562275|Secondary|Number of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|RECIST v1.1 (for measurable disease), CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|Safety analysis population.||participants|||Number
32605|NCT01562275|Secondary|Last Measurable Concentration (Clast) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."||ng/mL||Standard Deviation|Mean
32606|NCT01562275|Secondary|Time Taken to Reach Cmax (Tmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."||hours||Full Range|Median
32607|NCT01562275|Secondary|Maximum Plasma Concentration (Cmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
32608|NCT01562275|Secondary|Area Under Concentration-Time Curve From Time Zero to Last Measurable Concentration After Dose [AUC0–Last] of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population: Included all participants who received study treatment and had at least 1 cobimetinib and ipatasertib plasma concentration available. n represents the number of participants who were evaluable for that particular assessment."||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
32609|NCT01562275|Primary|Number of Participants With At Least One AE Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version (V) 4.0|AE was defined in Outcome Measure 3. AEs were graded as per NCI CTCAE V 4.0 as follows: G 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL) (instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money and others); G 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL (refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden); G 4: Life-threatening consequences, urgent intervention indicated; G 5: Death related to AE. If a participant had multiple events of different grades, the highest grade that occurred in that participant was counted.|From Baseline up to 30 days after the last dose of study treatment or until initiation of another anticancer treatment whichever occurred first (Up to 33 months)|Safety analysis population.||participants|||Number
32610|NCT01562275|Primary|Maximum Tolerated Doses (MTDs) in Combination of Cobimetinib and Ipatasertib During Dose-Escalation Stage 1|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. On the basis of AEs that did not meet protocol-defined DLT criteria (defined in Outcome measure 1) but indicated intolerability of a given dose combination, the combination MTDs were determined (as per investigator) during Stage 1 of the study.|Cycle 1 (28 Days)|Safety analysis population participants from dose escalation cohorts.||milligrams|||Number
32630|NCT01561469|Secondary|Number of Antibiotic Free Days||Up to 28 days after diagnosis of VAP|Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.|||||
32631|NCT01561469|Secondary|Duration of Antimicrobial Treatment||Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Standard Deviation|Mean
32632|NCT01561469|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Inter-Quartile Range|Median
32611|NCT01562275|Primary|Number of DLTs Categorized as Per the Nature|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) G ≥3 febrile neutropenia, b) G ≥4 neutropenia (ANC <500/μL) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or ALP lasting >3 days, f) Hepatic transaminases >3 × ULN and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days. Hematologic, Hepatic and non-hematologic and non-hepatic DLT categories were to be reported.|Cycle 1 (28 Days)|Data for this outcome measure was not analyzed as no participant experienced DLT.|||||
32612|NCT01562275|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) Grade (G) ≥3 febrile neutropenia, b) G ≥4 neutropenia (absolute neutrophil count [ANC] <500/ microliter [μL]) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or alkaline phosphatase (ALP) lasting >3 days, f) Hepatic transaminases >3 × Upper Limit of Normal (ULN) and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days.|Cycle 1 (28 Days)|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome was analyzed in safety analysis population participants in dose escalation cohorts.||participants|||Number
32613|NCT01562132|Secondary|Cryptococcal Meningitis-free Survival at 24 Weeks|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.~Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks||||||
32614|NCT01562132|Secondary|Number of Individuals With Treatment Related Serious Adverse Events||24 weeks||||||
32615|NCT01562132|Secondary|Number of Individuals With Treatment Related Adverse Events||24 weeks||||||
32616|NCT01562132|Secondary|Proportion of Individuals Requiring Dose Reduction||24 weeks||||||
32617|NCT01562132|Secondary|Proportion of Individuals Requiring Treatment Discontinuation||4 weeks||||||
32618|NCT01562132|Secondary|Achieve Targeted Recruitment, Retention and Adherence Rates||24 weeks||||||
32619|NCT01562132|Secondary|Number of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus|"Individuals who develop clinical meningitis without evidence of fungal, bacterial, or parasitic (e.g. malaria) organisms in the cerebrospinal fluid. Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks||||||
32620|NCT01562132|Secondary|Number of Individuals Who Develop Cryptococcal Meningitis|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.~Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks||||||
32621|NCT01562132|Secondary|Survival at 24 Weeks||24 weeks||||||
32622|NCT01562132|Secondary|Survival at 2 Weeks||2 weeks||||||
32623|NCT01562132|Primary|Survival at 12 Weeks||12 weeks|||participants|||Number
32624|NCT01561898|Primary|Incidence of Adverse Events|The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.|48 weeks|Intent-to-treat (ITT) population||percentage of patients|||Number
32625|NCT01561898|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|Baseline, Week 48|Intent-to-treat (ITT) population||scores on a scale||Standard Deviation|Mean
32626|NCT01561898|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS)|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 48|Intent-to-treat (ITT) population||scores on a scale||Standard Deviation|Mean
32627|NCT01561716|Primary|Energy Expenditure|Energy expenditure is measured using continuous, computerized open-circuit indirect calorimetry (oxygen consumption and carbon dioxide production) and converted to metabolic equivalents (METs).|30 min continuous monitoring at rest and during each physical activity|||METs||Standard Deviation|Mean
32628|NCT01561703|Primary|Healthcare Utilization|Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.|6 wks post-operative appointment|||participants|||Number
32629|NCT01561560|Primary|End-of-day Comfort|"End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, Please rate the study lenses you have been wearing the in the following area: End-of-day comfort and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent)."|Week 2|This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.||Units on a scale||Standard Deviation|Mean
32658|NCT01560260|Secondary|OS|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks||||||
32633|NCT01561469|Secondary|Duration of Intensive Care Unit (ICU) Stay|Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Inter-Quartile Range|Median
32634|NCT01561469|Secondary|Duration of Hospital Stay|Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||days||Inter-Quartile Range|Median
32635|NCT01561469|Secondary|Number of Participants With Microbiological Outcome|Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).|28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.||participants|||Number
32636|NCT01561469|Primary|Percentage of Participants With Clinical Success|Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.|14 days after diagnosis with VAP or hospital discharge, whichever occurred first|Analysis population included all participants who met the eligibility criteria for this study.||percentage of participants|||Number
32637|NCT01561313|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious Adverse Events were collected from the time the participant signed the informed consent.|||participants|||Number
32638|NCT01561313|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
32639|NCT01561313|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
32640|NCT01561313|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
32641|NCT01561313|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
32642|NCT01561313|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection, with 0 representing no pain and 10 representing the worst possible pain.|15 minutes post injection|||cm||Standard Deviation|Mean
32643|NCT01561313|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection|||cm||Standard Deviation|Mean
32644|NCT01560975|Secondary|Effect After CPAP Removal on the IOP Pattern|IOP pattern immediately after CPAP removal upon waking in patients with or without POAG|30 min|||mvEq||Standard Deviation|Mean
32645|NCT01560975|Secondary|Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters|"Heart rate and ocular pulsation rate during sleep:~using CPAP in patients with or without POAG~not using CPAP in patients with or without POAG"|24-hours|||Correlation||Standard Deviation|Mean
32646|NCT01560975|Primary|Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG|"24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS.~using CPAP in patients with or without POAG~not using CPAP in patients with or without POAG"|24 hours|||mVEq/h||Standard Deviation|Mean
32647|NCT01560819|Primary|Clinical Response|Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment|4 weeks following GMT Treatment|One participant showed intolerance to the treatment (immediate leaking of enema) and was not included in post-treatment disease activity evaluation.||Participants|||Number
32648|NCT01560507|Secondary|Quit Success Genotype Score|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.”|After 6 month Follow-Up|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
32649|NCT01560507|Primary|Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|End of study drug treatment period (11-12 weeks)||||||
32650|NCT01560429|Primary|Anesthetic Consumption (mg)|amount of anesthetic consumed was calculated for each group over time.|4,8,12, 24 and 48 hours postoperatively|||mg||Standard Error|Mean
32651|NCT01560429|Secondary|Worst Pain While Coughing|Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy|48 hours postoperatively||||||
32652|NCT01560429|Secondary|Worst Pain Scores|worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery|48 hours postoperatively||||||
32653|NCT01560429|Primary|Local Anesthetic Consumption|Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.|48 hours postoperatively|||ug||Standard Error|Mean
32654|NCT01560403|Primary|Summary of Treatment-emergent Adverse Events|As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.|12 months|Safety Population||participants|||Number
32655|NCT01560260|Secondary|Time to Progression|Evaluated using cumulative incidence.|Up to 2 years||||||
32656|NCT01560260|Secondary|Response Duration|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks||||||
32657|NCT01560260|Secondary|PFS|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Time from date of enrollment to time of progression or death due to any cause, assessed up to 37 weeks||||||
32662|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum|Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set||ratio||95% Confidence Interval|Least Squares Mean
32663|NCT01560234|Primary|Summary for Lymphocytes Laboratory Results||Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)|Safety Analysis Set||cells*10^9/L||Standard Deviation|Mean
32664|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 48 Hours|Pharmacodynamic Population Set||ratio||95% Confidence Interval|Least Squares Mean
32665|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set||ratio||95% Confidence Interval|Least Squares Mean
32666|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population||nmol/L||Geometric Coefficient of Variation|Geometric Mean
32667|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
32668|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
32669|NCT01560234|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event|Screening up to Day 13|Safety Analysis Set||participants|||Number
32670|NCT01560143|Primary|Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours|The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L)|4 days (96 hours)|||hour*mg/L||Standard Deviation|Mean
32671|NCT01559922|Primary|ASRS Responder Rate at 6 Months|"Subject considered to be a responder if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment)."|6 months post-treatment|Full Analysis Population included only subjects that passed screening||percentage of participants||95% Confidence Interval|Number
32672|NCT01559844|Primary|Number of Participants Who Died|"Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days.~Only those participants who underwent liver transplantation were analyzed for death post-transplantation."|Up to 48 weeks following transplant|Safety Analysis Set||participants|||Number
32673|NCT01559844|Secondary|Proportion of Participants With Virologic Failure Prior to Transplant|"Virologic failure (VF) in the pretransplant phase was defined by:~Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA < 25 IU/ml, while on treatment)~Rebound (breakthrough or > 1 log10 IU/ml increase in HCV RNA from nadir while on treatment)~Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment)~Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA < 25 IU/ml at last observed HCV RNA on treatment)"|Up to 48 weeks prior to transplant|On-treatment VF: Full Analysis Set. Posttreatment/Pretransplant VF - 24 Weeks or 48 Weeks: Participants who completed 24 or 48 weeks of treatment and had an observed or imputed Week 4 posttreatment follow-up HCV RNA value relapsed during posttreatment follow-up were analyzed.||percentage of participants|||Number
32674|NCT01559844|Secondary|HCV RNA and Change From Baseline in HCV RNA Through Week 8||Up to 8 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
32675|NCT01559844|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48||Up to 48 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
32676|NCT01559844|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant.|Up to 48 weeks following transplant|Participants in the Full Analysis Set who underwent liver transplantation and who had ≥ 12 weeks treatment and HCV RNA < LLOQ at last measurement prior to transplant were analyzed.||percentage of participants|||Number
32677|NCT01559844|Primary|Percentage of Participants With Graft Loss Following Transplant||Up to 48 weeks following transplant|Participants in the Safety Analysis Set who underwent liver transplantation were analyzed.||percentage of participants|||Number
32678|NCT01559844|Primary|Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant||Up to 48 weeks prior to transplant|Safety Analysis Set||percentage of participants|||Number
32679|NCT01559844|Primary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant.|Posttransplant Week 12|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study drug) who underwent liver transplantation, and who had HCV RNA < LLOQ at last measurement prior to transplant were analyzed.||percentage of participants|||Number
32680|NCT01559675|Secondary|Postoperative Pain|Assessed daily by visual analog pain score (0 to 10; no pain to severe)|Postoperative day 1 - 7||||||
32681|NCT01559675|Secondary|Hemodynamic Instability|Hemodynamic instability defined by heart rate >100 bpm, <60 bpm, Systolic blood pressure <90 mm Hg|From time of surgical incision to Postoperative day 7||||||
32682|NCT01559675|Secondary|Length of Postoperative Hospitalization (Days)||Duration of hospital stay (expected average of 5 days)||||||
32683|NCT01559675|Secondary|Minor and Major Medical and Surgical Complications||Through Postoperative day 30||||||
32684|NCT01559675|Secondary|Postoperative Fatigue|Measured daily, score 0 (no fatigue) to 10 (very fatigued)|Postoperative day 1 - 7||||||
32685|NCT01559675|Secondary|Postoperative Nausea|Measured daily Postoperative day 1 - 7 on a scale from 0 (no nausea) to 10 (nausea as bad as can be)|Postoperative day 1 - 7||||||
32688|NCT01559649|Secondary|Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items|Determine if stroke-ward staff nurses can make reliable inter-rater judgments of swallowing (e.g. cough after swallow, wet voice after swallow) and nonswallowing features (e.g. decreased volitional cough, dysarthria) historically used by SLPs to make judgments of aspiration.|3 years|||kappa||95% Confidence Interval|Number
32689|NCT01559649|Secondary|Average Accuracy Rate for Nurse Administration for All Screening Procedures|Determine if current stroke-ward staff nurses can accurately administer screening items.|3 years|||percentage of accuracy||Full Range|Mean
32690|NCT01559649|Primary|Negative Predictive Value of Screening Items|Identify the combination of screenings items that provide the highest level of negative predictive value in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure||percentage of agreement||95% Confidence Interval|Number
32691|NCT01559649|Primary|Specificity of Screening Items|Identify the combination of screenings items that provide the highest level of specificity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure||percentage of agreement||95% Confidence Interval|Number
32692|NCT01559649|Primary|Sensitivity of Screening Items|Identify the combination of screenings items that provide the highest level of sensitivity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure||percentage of agreement||95% Confidence Interval|Number
32693|NCT01559506|Primary|CFU Density|Colony-forming unit density at incision site (CFU/m3)|Surgical case CFU density will be determined at up to 1 month from completion of surgical cases|||CFU/m^3||95% Confidence Interval|Mean
32694|NCT01559311|Primary|LVESV|Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.||ml||Standard Deviation|Mean
32695|NCT01559311|Primary|LVEF|Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.||% LVEF||Standard Deviation|Mean
32696|NCT01559116|Secondary|Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment.~Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)||Litres (L)||Standard Error|Mean
32697|NCT01559116|Secondary|Trough FVC Response [L] After 6 Weeks Treatment.|"Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period.~The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
32698|NCT01559116|Secondary|FVC AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
32699|NCT01559116|Secondary|FVC AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)||Litres (L)||Standard Error|Mean
32700|NCT01559116|Secondary|FVC AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres(L)||Standard Error|Mean
32701|NCT01559116|Secondary|Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response.~The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
32930|NCT01556724|Secondary|Increased Infusion Rates|Number of patients requiring increased infusion rates to better optimize pain control|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)||||||
32702|NCT01559116|Secondary|Trough FEV1 Response [L] After 6 Weeks Treatment.|"Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period.~The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)||Litres||Standard Error|Mean
32703|NCT01559116|Secondary|FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
32704|NCT01559116|Secondary|FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).||Litres (L)||Standard Error|Mean
32705|NCT01559116|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS): This patient set included patients in the Treated Set (TS) who had any period baseline and any evaluable post-dose data for the primary efficacy endpoint at any Week 6 visits.||Litres (L)||Standard Error|Mean
32706|NCT01559064|Primary|Subject Experience Measured by Patient Satisfaction Questionnaire|Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy|3 weeks|||Units on a scale||Standard Deviation|Mean
32707|NCT01559012|Secondary|Diastolic Blood Pressure|Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle|10 days|||mmHg||95% Confidence Interval|Mean
32708|NCT01559012|Secondary|Systolic Blood Pressure|Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)|10 days|||mmHg||95% Confidence Interval|Mean
32709|NCT01559012|Secondary|Newborn Outcome Measure: APGAR Score.|"The APGAR score is the most common indicator of neonatal status immediately after delivery.~The test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's:~Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth."|at 1 minute and at 5 minutes after delivery|APGAR score of newborns at 1 minute and at 5 minutes||units on a scale||Full Range|Mean
32710|NCT01559012|Secondary|Pregnancy Outcome Measures: Birth Weight.|Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.|at delivery|no determination of sample size Recording for safety issue||grams||Full Range|Mean
32711|NCT01559012|Secondary|Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.|the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective|at 10 days since start of treatment|no determination of sample size||participants|||Number
32712|NCT01559012|Secondary|Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only|if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days|||Proportion of person-days||95% Confidence Interval|Mean
32713|NCT01559012|Secondary|Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.|"The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis.~All patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms."|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days|||daily doses of antiemetics||95% Confidence Interval|Mean
32714|NCT01559012|Secondary|Morning Urine Ketonuria|Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days|||Proportion of person-days||95% Confidence Interval|Mean
32715|NCT01559012|Primary|VAS Score for Assessment of Severity in Hyperemesis Gravidarum|VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.|||units on a scale||95% Confidence Interval|Mean
32931|NCT01556724|Secondary|NRS Pain Score|Pain scores (VAS; at rest and with physical therapy; 0-10) at 24 hours postoperative|24 hours postoperatively||||||
32716|NCT01559012|Primary|PUQE Score for Assessment of Severity in Hyperemesis Gravidarum|"PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy.~It is composed of three items; every item has a score from 1 (best) to 5 (worst).~The sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily."|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.|A sample size calculation for crossover studies using a model available on line (MGH Mallinckrodt General Clinical Research Center - Harvard Medical School) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P < 0.01 and a beta > 0.90.||units on a scale||95% Confidence Interval|Mean
32717|NCT01558791|Primary|Illness Perception - Duration of Symptoms|Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted questionnaire||units on a scale||Standard Deviation|Mean
32718|NCT01558791|Primary|Illness Perception - Current Symptoms|Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans who accepted questionnaire||units on a scale||Standard Deviation|Mean
32719|NCT01558791|Secondary|Feasibility Questionnaire|A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.|One month- Providers complete a questionnaire within 1 month after data collection ends for the site.||||||
32720|NCT01558791|Primary|mTBI Questionnaire|The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted the questionnaire.||correct answers out of 10||Standard Deviation|Mean
32721|NCT01558739|Secondary|Percentage of Participants With Transfusion Dependency Status|Transfusion dependency status from baseline through the end of study was assessed. New onset of transfusion dependency was defined as the use of 2 or more units of red blood cell products during the 8 weeks prior to a study visit. New onset of transfusion independency was defined as the use of 0 or 1 unit of red blood cell products during the 8 weeks prior to a study visit.|baseline (BL), end of treatment (up to 28 days post last treatment) (EOT)|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
32722|NCT01558739|Secondary|Number of General Practitioner (GP), Specialists' and Urgent Care Visits|MRU was assessed according to the number of GP, specialists', and urgent care visits.|baseline to week 12, week 12 to, week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||number of visits||Full Range|Median
32723|NCT01558739|Secondary|Number of Accident & Emergency Visits From Baseline|MRU was assessed according to the number of accidents and emergency room visits.|baseline to week 12, week 12 to week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Number of visits||Full Range|Median
32724|NCT01558739|Secondary|Duration of Hospitalizations|MRU was assessed according to the mean duration of hospitalization visits.|week 48|Participants from the full analysis set, who were hospitalized between baseline and week 48, were included in the analysis.||days||Standard Deviation|Mean
32725|NCT01558739|Secondary|Number of Hospitalizations|Medical resource utilization (MRU) was assessed according to the number of hospitalizations.|week 12, week 24, week 26, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at the post-baseline week time point, were included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||number of hospitalizations||Standard Deviation|Mean
32726|NCT01558739|Secondary|Change From Baseline in EQ5D Preference Index (5 Level EuroQol Questionnaire Determining Quality of Life) From Baseline|The EQ-5D is a standardized instrument used for measuring health outcomes in a wide range of health conditions and treatment. It consists of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ-VAS records the participant's self-rated health on a vertical, VAS where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state'. The EQ-5D health state was converted to a single summary index by applying a formula that attaches a weight to each of the levels in each dimension. The final EQ5D preference index scores range from 0 to 1 with higher scores indicating better health.|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||unit on a scale||Standard Deviation|Mean
32740|NCT01558271|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks|Pancreatic enzyme (lipase and total amylase) concentrations were measured.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pancreatic enzyme data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units/liter||Inter-Quartile Range|Median
32932|NCT01556724|Secondary|Patient Satisfaction With Pain Control|Patient satisfaction with pain control at 24 hours (0-10 scale)|24 hours postoperatively||||||
32727|NCT01558739|Secondary|Change From Baseline in Myelofibrosis Symptoms Assessment Form (MF-SAF)|The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions are scored on a scale of 0–10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1–6, which together comprise a Total Symptom Score (TSS), investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asks patients to report levels of inactivity. The TSS reflects the sum of the scores of these symptoms excluding inactivity, with the maximum possible score being 60 (most severe symptom experienced).|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||score on a scale||Standard Deviation|Mean
32728|NCT01558739|Secondary|Percentage of Participants With Best Overall Response|Response to treatment and disease progression was assessed by physical examination, specifically assessing changes in spleen size by palpation. Disease response and progression was evaluated using the International Working Group for myelofibrosis Research and Treatment Response Criteria.|week 48|Full Analysis Set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
32729|NCT01558739|Primary|Percentage of Participants With Treatment Success|Treatment success was defined as a 50% or greater reduction in palpable spleen length versus baseline at 48 weeks and/or a 50% or greater improvement in total symptom score (derived from the MF symptom assessment form (MFSAF) questionnaire) versus baseline at the week 48 time point. The MFSAF assesses the following symptoms (all scored from absent (0) to worst imaginable (10)): general fatigue, abdominal pain (and discomfort), inactivity (ability to move and walk around), cough, night sweats, itching (pruritus), bone pain (diffuse not joint pain or arthritis), fever, change in appetite/unintentional weight loss (or gain) in past 6 months, overall quality of life (QoL).|48 Weeks|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
32730|NCT01558700|Secondary|Change in Pain Magnitude|The Western Ontario and McMaster Osteoarthritis Index (WOMAC) score change was assess by subtracting WOMAC score after treatment (week 16) to the baseline WOMAC score. WOMAC score has a range from 0 up to 96, higher score meaning worse condition. The outcome is the decrease in WOMAC scores, meaning that the higher is the decrease, the most improvement in the condition.|16 weeks compared to baseline|||Scores on a scale||Standard Deviation|Mean
32731|NCT01558700|Primary|Change in Brain Gray Matter Volume|The change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline)|16 weeks compared to baseline|||percentage of change||Standard Deviation|Mean
32732|NCT01558596|Primary|Troponin I Elevation Above the URL|Troponin I is biomarker of myocardial necrosis|Within 3 days of the vascular operation|||participants|||Number
32733|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).|6 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.||pounds||Standard Deviation|Mean
32734|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 3 months after first treatment session.|3 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.||pounds||Standard Deviation|Mean
32735|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 1.5 months after first treatment session.|1.5 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.||pounds||Standard Deviation|Mean
32736|NCT01558271|Secondary|Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks|Fridericia Corrected QT (QTcF) Interval and PR Interval are summarized. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means were calculated using ANCOVA model with treatment as a fixed effect and the baseline ECG parameter as the covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable ECG data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milliseconds (msec)||Standard Error|Least Squares Mean
32737|NCT01558271|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26 and 52 weeks.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||participants|||Number
32738|NCT01558271|Secondary|Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks|A participant was considered to have treatment-emergent LY2189265 ADAs if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from the baseline measurement.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication and had LY2189265 evaluable ADA data.||participants|||Number
32739|NCT01558271|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks||Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable serum calcitonin data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms/milliliter||Inter-Quartile Range|Median
32741|NCT01558271|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks|Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||participants|||Number
32742|NCT01558271|Secondary|Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable blood pressure data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milliliters of mercury (mmHG)||Standard Error|Least Squares Mean
32743|NCT01558271|Secondary|Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks|Sitting pulse rate was measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline pulse rate as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pulse rate data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||beats per minute (bpm)||Standard Error|Least Squares Mean
32744|NCT01558271|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||participants|||Number
32745|NCT01558271|Secondary|30-Day Rate of Hypoglycemic Episodes|The 30-day total hypoglycemia rate over 26 weeks and 52 weeks of treatment is summarized. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication. One participant in the Liraglutide reporting group received study drug but discontinued from the study on the same day and, therefore, was not included in the analysis.||events per participant per 30 days||Standard Deviation|Mean
32746|NCT01558271|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week or 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.||percentage of participants|||Number
32747|NCT01558271|Secondary|Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in beta-cell function was assessed based on change from baseline of HOMA2-%B using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%B as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%B data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.||percentage of HOMA2||Standard Error|Least Squares Mean
32748|NCT01558271|Secondary|Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in insulin sensitivity was assessed based on change from baseline of HOMA2-%S using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%S as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%S data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.||percentage of HOMA2||Standard Error|Least Squares Mean
32749|NCT01558271|Secondary|Change From Baseline in Body Weight at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
32933|NCT01556724|Primary|Opiate Consumption Postoperatively|Postoperative opiate consumption at 24 hours|24 hours postoperatively|||mg||95% Confidence Interval|Mean
32750|NCT01558271|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, and at bedtime. LS means were calculated using analysis of covariance (ANCOVA) model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline SMBG as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
32751|NCT01558271|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable FBG data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
32752|NCT01558271|Secondary|Percentage of Participants Who Achieved HbA1c <=6.5% or <7%|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% at Week 26 and Week 52 was analyzed with a Cochran-Mantel-Haenszel test stratified by prestudy therapy (OAM yes/no) and baseline BMI group (<25 or >=25 kg/m^2).|Up to 26 and 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.||percentage of participants|||Number
32753|NCT01558271|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 52 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.||percentage of HbA1c||Standard Error|Least Squares Mean
32754|NCT01558271|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication [OAM] yes/no), baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.||percentage of HbA1c||Standard Error|Least Squares Mean
32755|NCT01558089|Secondary|Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)|In a first step a univariate logistic regression model was fit for the following baseline variables: DAS28 (n=48), Physician’s Global Assessment of Disease Activity (VAS) (n=47), Patient’s Global Assessment of Disease Activity (VAS) (n=47), CRP (n=46), Patient Pain (VAS) (n=47), HAQ-DI (n=47), EQ-5D (n=47). Only those variables that were significant at a 10% level were then included in the second step: a multivariate analysis with stepwise regression (entry level=10%, stay level=5%). The final model presented in the Basic Results table displays those covariates which were significant at the 2-sided 5% level (baseline value for DAS28; n=48). Note that DAS28 is not a categorical variable; therefore no stratified results for this variable are presented.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||Odds Ratio (per unit increase)||95% Confidence Interval|Number
32756|NCT01558089|Secondary|Change From Baseline in HAQ-DI at Visit 4 (Month 6)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is composed of 20 items. It is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score ranges from 0-3: 0=least difficulty and 3=extreme difficulty.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||units on scale||Standard Deviation|Mean
32757|NCT01558089|Secondary|Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)|The European Quality of Life–5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||units on scale||Standard Deviation|Mean
32758|NCT01558089|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)||Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||mm/hour||Standard Deviation|Mean
32759|NCT01558089|Secondary|Change From Baseline in Patient’s Assessment of General Health (VAS) at Visit 4 (Month 6)|The patients used a 100 mm Visual Analogue Scale (VAS) to score their general health during the last week. The scale ranged from 0 (no pain) to 100 mm (severe pain)|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||mm||Standard Deviation|Mean
32760|NCT01558089|Secondary|Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was ‘Present’. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||Joints||Standard Deviation|Mean
32761|NCT01558089|Secondary|Change From Baseline in Tender Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was ‘Present’. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the Full Analysis Set (FAS) population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.||Joints||Standard Deviation|Mean
32762|NCT01558089|Primary|Primary: Participants With EULAR (Good)|Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 >5.1|Visit 4 (Month 6)|Last observation carried forward (LOCF) was applied where data were available. Participants where a EULAR response value could not be calculated, were omitted from the analysis. Only 48 Participants had available EULAR response data at 6 months.||participants|||Number
32763|NCT01557959|Secondary|Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||2 years||||||
32764|NCT01557959|Secondary|Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||1 year||||||
32765|NCT01557959|Secondary|Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||2 years||||||
32766|NCT01557959|Secondary|Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||1 year||||||
32767|NCT01557959|Primary|Time to Progression|Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2 years|||months||95% Confidence Interval|Median
32768|NCT01557920|Post-Hoc|Frequency of Spontaneous Swallows During Anesthesia vs Wakefulness|The number of swallows were counted during wakefulness and anesthesia. The frequency of swallowing was calculated per hour|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows). If the pathological swallow incidence between sevoflurane and propofol anesthesia had a p-value >0.05, subsequent analyses were conducted to evaluate depth of anesthesia related differences rather than compound specific ones.||number of swallows/hr||Standard Deviation|Mean
32769|NCT01557920|Secondary|Duty Cycle|(T(ins)/T(total))*100|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of Duty cycle.||percentage of Ttotal||Standard Deviation|Mean
32770|NCT01557920|Secondary|Minute Ventilation (Tidal Volume and Respiratory Rate)|Measured by spirometry. Subjects wear a full-face mask. Reported in L/min|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of minute ventilation.||L/min||Standard Deviation|Mean
32771|NCT01557920|Secondary|Genioglossus Muscle Electromyogram|will be measured during steady state anesthesia as well as during carbon dioxide reversal, and during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|The number of participants in this group are only 9 since the genioglossus EMG signals were poor in 2 participants and these were excluded from the analysis.||percentage of maximum recorded activity||Standard Error|Mean
32772|NCT01557920|Secondary|Airway Diameter|Using acoustic pharyngometry, we intend to measure the cross-sectional area of the airway at several points during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|No data were obtained.|||||
32773|NCT01557920|Primary|Proportion of Pathological Swallows|A pathological swallow was defined as a swallow that was followed by inspiratory flow. A physiological swallow was defined as a swallow that was followed by expiratory flow. The number of pathological and physiological swallows were measured during wakefulness and anesthesia. The pathological swallows are presented as percentage of path. swallows calculated as path.sw/[path.sw+phys.sw]*100 (%).|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows).||percentage of pathological swallows|||Number
32774|NCT01557920|Primary|Upper Airway Closing Pressure|Upper airway closing pressure will be measured during steady state anesthesia as well as during carbon dioxide reversal.|participants will be followed for the duration of anesthesia, an expected average of 6 hours|Ten out of 12 subjects were analyzed. In two subjects we could not record high quality biologically plausible recordings of upper airway closing pressure. Data from multiple measurements per participant were combined to calculate an average upper airway closing pressure per subject.||cm H20||Standard Deviation|Mean
32775|NCT01557894|Secondary|Anxiety Sensitivity Index (ASI)|The Anxiety Sensitivity Index (ASI) is a 16-item questionnaire that measures the beliefs about the social and somatic consequences of anxiety symptoms. The total ASI score ranges from 0 to 64, with higher scores corresponding to greater anxiety sensitivity.|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
32776|NCT01557894|Secondary|Attitude and Belief Scale-II (ABS-II)|"The Attitude and Belief Scale-II (ABS-II) measures rational and irrational thinking as described by Albert Ellis. The scale was designed to capture four cognitive processes (i.e., demandingness, awfulizing, low frustration tolerance, and self-downing/global evaluation) in three content areas (i.e., achievement, approval, and comfort). We selected the 72-item ABS-II because preliminary psychometrics are available for the Romanian population.~The total ABS-II score range from 0 to 360, with higher scores corresponding to greater irrationality."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
32777|NCT01557894|Secondary|Beck Depression Inventory-II (BDI-II)|"Beck Depression Inventory-II (BDI-II) is a 21-item self-report inventory widely used to assess DSM-IV depressive symptoms. Each item consists of four statements, scored 0–3, indicating increasing symptom severity.~Thus, for BDI-II the range of scores is 0-63, with higher scores reflecting higher levels of depression."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
32778|NCT01557894|Primary|Social Phobia Inventory (SPIN)|"The Social Phobia Inventory (SPIN) is a brief (i.e., 17-item) self-report instrument measuring fear in social situations, avoidance of performance/social events, and physiological discomfort in social situations. Each item is rated on a 4-point scale.~Thus, for SPIN the range of scores is 0-68, with higher scores reflecting higher levels of social anxiety symptomatology"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
32779|NCT01557894|Primary|Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)|"The Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) measures social anxiety.~LSAS-SR presents 24 commonly anxiety-provoking situations, and asks participants to rate their fear and avoidance for each situation.~In order to obtain the total LSAS-SR score the Anxiety and Avoidance subscales scores are added together.~The LSAS-SR total score ranges from 0-144, with higher scores corresponding to greater social anxiety"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)|||units on a scale||Standard Deviation|Mean
32780|NCT01557868|Secondary|Visual Analogue Scale (VAS) at 6 Months|The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement.|Assessments were at baseline to 6 month follow-up|The discrepancy between the number of subjects included in this analysis (140) and the number of subjects reported completing the study (141) is due to a missing values for one subject for this variable.||units on a scale||Standard Deviation|Mean
32781|NCT01557868|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale|"The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the best score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline."|Baseline and at 6 month follow-up|||units on a scale||Standard Deviation|Mean
32782|NCT01557842|Primary|Cardiac-related Death|Subjects with cardiac-related death|2 years follow up|All enrolled subjects||percentage of participants|||Number
32783|NCT01557842|Primary|Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events|The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.|From one month to 2 years follow up|All enrolled subjects||percentage of participants|||Number
32784|NCT01557699|Secondary|Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84|Geometric Mean Titre by Plaque Reduction Neutralization Test were assessed on Day -7, 28 and 84 at CDC, Atlanta. Titers are expressed as IU/ml.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||IU/ml||95% Confidence Interval|Geometric Mean
32785|NCT01557699|Secondary|Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies|Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies were measured on Day -7, Day 28 and Day 84 by ELISA using Trinity ELISA Kits for Measles.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||IU/ml||95% Confidence Interval|Geometric Mean
32786|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for PRNT|The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||percentage of participants|||Number
32787|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG|The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.||percentage of participants|||Number
32880|NCT01556997|Secondary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).||Day 0 to Day 42|The Analysis Population for the Secondary Outcome (Change from baseline to end of treatment in the mean seated trough cuff systolic blood pressure (SBP)) consists of the Intent-to-treat population for the study||mmHg||Standard Deviation|Mean
32788|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre|The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.||percentage of participants|||Number
32789|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies|The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.||percentage of participants|||Number
32790|NCT01557699|Primary|Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions|Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.|Day 180|Intention-To-Treat (ITT) Population was used for safety and immunogenicity analysis. ITT population included subjects who had blood drawn to confirm a measles protective titer at Day -7 and met all inclusion/ exclusion criteria and did not receive a vaccine forbidden in the study protocol within the previous 30 days.||participants|||Number
32791|NCT01557699|Primary|Incidence of Unsolicited Adverse Events Within 84 Days|Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.|Day 84|Intention-To-Treat (ITT) Population was used for safety analysis.||participants|||Number
32792|NCT01557699|Primary|Incidence of Solicited Reactions|Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.|Day 14|Intention-To-Treat (ITT) Population included all subjects who received at least one dose of study vaccine and had at least one post-baseline assessment, regardless of whether they adhered to the study eligibility criteria or whether their study medication administration and study procedure visits are within the protocol-specified windows.||participants|||Number
32793|NCT01555567|Secondary|Central Activation Ratio|CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force|Time of return to activity (~6 months following surgery)|||ratio||Standard Deviation|Mean
32794|NCT01555567|Primary|Quadriceps Strength||Time of return to activity (~6 months following surgery)|||Nm/kg||Standard Deviation|Mean
32795|NCT01557595|Secondary|Wake Up and Bedtime Diaries|At the screen visit, participants will receive 7 sets of Wake Up and Bedtime Diaries and be instructed to complete them twice daily. At the baseline visit, the completed diaries will be retrieved, and participants will be given 14 sets of Wake Up and Bedtime Diaries. Participants will also be given the polarized glasses to wear from sundown until bedtime for 2 weeks. Diaries will be filled out daily for 2 weeks. All forms will be collected with the glasses after the 2 weeks, at the termination visit.|Change from baseline in diaries at 2 weeks||||||
32796|NCT01557595|Primary|Change in Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline|The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality. The PSQI is considered appropriate in identifying “new-onset” insomnia in the clinical setting.|Change from baseline in PSQI at 2 weeks|||units on a scale||Full Range|Mean
32797|NCT01557582|Secondary|Intra-Observer Variability|Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|||Percent difference||Standard Deviation|Mean
32798|NCT01557582|Secondary|Inter-Observer Variability|A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|All evaluable subjects.||Percent difference||Standard Deviation|Mean
32799|NCT01557582|Primary|Observed Mean (Std Err) for % Difference Between VMS and MRI.|% Difference was measured for right ventricular EDV, ESV and EF.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|Only evaluable participants were analyzed||Percent difference||Standard Error|Mean
32800|NCT01557569|Primary|Time Till Relapse|The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse)|57 days|Only 4 of 13 finished the 2-week residential stay. Since subjects who drop out are deemed relapsed, all subjects receiving >/=1 dose of study med were included in the analyses. Those who dropped out before completing the residential stay were considered relapsed by the second day and the date of discharge was subtracted from this relapse date.||Days to Relapse||Full Range|Median
32801|NCT01557504|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.|Up to 9 days|All participants as treated defined as all participants who received at least one dose of study drug.||Participants|||Number
32802|NCT01557504|Primary|Number of Participants Who Experienced an Abnormal Vital Sign Value|Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.||Participants|||Number
32803|NCT01557504|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.||Participants|||Number
32804|NCT01557504|Primary|Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||Hour||Geometric Coefficient of Variation|Geometric Mean
32805|NCT01557504|Primary|Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||Hour||Full Range|Median
32806|NCT01557504|Primary|Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
32807|NCT01557504|Primary|Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM||Geometric Coefficient of Variation|Geometric Mean
32808|NCT01557504|Primary|Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
32809|NCT01557504|Primary|AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr/mL||Geometric Coefficient of Variation|Geometric Mean
32810|NCT01557504|Primary|AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
32811|NCT01557504|Primary|Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours (hrs) prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hrs post study drug administration. Owing to resumption of therapeutic metformin administration 24 hrs after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and area under the curve 0 to 24 hrs (AUC0-24hr). Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.||nM*hr||Geometric Coefficient of Variation|Geometric Mean
32812|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 9|The Swallowing Ability Questionnaire was completed on Day 9 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 9|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 9, all participants received matching placebo, so the two treatment groups were pooled on Day 9.||Participants|||Number
32813|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 6|The Swallowing Ability Questionnaire was completed on Day 6 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 6|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 6, all participants received matching placebo, so the two treatment groups were pooled on Day 6.||Participants|||Number
32881|NCT01556997|Primary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).||Day 0 to Day 42|The Analysis Population for the Primary Outcome (Change from baseline to end of treatment in the mean seated trough cuff diastolic blood pressure (DBP)) consists of the Intent-to-treat population for the study||mmHg||Standard Deviation|Mean
32814|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 4|The Swallowing Ability Questionnaire was completed on Day 4 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 4|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 4, all participants received matching placebo, so the two treatment groups were pooled on Day 4.||Participants|||Number
32815|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2|The Swallowing Ability Questionnaire was completed on Day 2 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 2|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 2, all participants received matching placebo, so the two treatment groups were pooled on Day 2.||Participants|||Number
32816|NCT01557348|Secondary|Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi|The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors.|Baseline|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.||participants|||Number
32817|NCT01557348|Secondary|Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy|The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.||participants|||Number
32818|NCT01557348|Secondary|Number of Participants With Previous TNFi Therapy|The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.||participants|||Number
32819|NCT01557348|Secondary|Number of Participants With Reasons for Discontinuation of the First TNFi Therapy|The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.||participants|||Number
32820|NCT01557348|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death|An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to 12 Months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.||participants|||Number
32821|NCT01557348|Secondary|Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice||Up to 12 months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (ie,Treatment Group) and reason for changing biologic therapy was known.||Number of participants|||Number
32822|NCT01557348|Secondary|Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy|Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.|Month 6 and Month 12|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (i.e,Treatment Group) and reason for changing biologic therapy was known.||Percentage of participants|||Number
32823|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||minutes||Standard Error|Least Squares Mean
32824|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||scores on a scale||Standard Error|Least Squares Mean
32825|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Participant’s VAS Pain Score at Months 6 and 12|Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain”. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm||Standard Error|Least Squares Mean
32826|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12|Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm||Standard Error|Least Squares Mean
32827|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12|Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm||Standard Error|Least Squares Mean
32828|NCT01557348|Secondary|Least Squares Mean Change From Baseline in ESR at Months 6 and 12|The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||mm/hr||Standard Error|Least Squares Mean
32829|NCT01557348|Secondary|Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12|C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||milligram/Liter||Standard Error|Least Squares Mean
32830|NCT01557348|Secondary|Least Squares Mean Change From Baseline in SJC at Months 6 and 12|The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||swollen joints||Standard Error|Least Squares Mean
32831|NCT01557348|Secondary|Least Squares Mean Change From Baseline in TJC at Months 6 and 12|The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.||tender joints||Standard Error|Least Squares Mean
32832|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.||scores on a scale||Standard Error|Least Squares Mean
32905|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.||pg/mL||Standard Deviation|Mean
32833|NCT01557348|Primary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.||scores on a scale||Standard Error|Least Squares Mean
32834|NCT01557322|Other Pre-specified|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 6|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
32835|NCT01557322|Other Pre-specified|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
32836|NCT01557322|Other Pre-specified|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Mean
32837|NCT01557322|Other Pre-specified|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, acute phase reactants (ESR, millimeters per hour or CRP, milligram per liter) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Mean
32838|NCT01557322|Other Pre-specified|Number of Participants Who Died or Hospitalized Due to Adverse Events|Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
32839|NCT01557322|Other Pre-specified|Number of Participants With Malignancy|Malignancy included lymphoproliferative tumors, Hodgkins lymphoma, myeloma, leukaemia, non-melanoma skin cancer, and solid tumor. Number of participants with each of these malignancies is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
32840|NCT01557322|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline.||participants|||Number
32841|NCT01557322|Primary|Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment|Direct costs included: outpatient costs, physician visits, outpatient surgery, emergency room visits, visits to healthcare professionals other than physicians, medications, diagnostic and/or therapeutic procedures, medical devices, inpatient costs, admission to acute-care nonsurgical departments, admission to acute-care surgical departments, admission to extended-care facilities, and other direct costs (travel expenses, home care, home remodeling, medical devices, non-physician healthcare professionals, alternative medicine practitioner, participant time). Indirect cost (related to lost productivity through morbidity and death) included: lost productivity in employed participants (disability, sick-leaves), lost opportunities (lost productivity in family members caring for the patient, disability requiring changes to everyday activities), and lost wages.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.|||||
32842|NCT01557322|Primary|Number of Rheumatoid Arthritis (RA) Related Visits|Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.|||||
32843|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.|||||
32844|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.|||||
32845|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 60|Result not reported as no participants were evaluable at this time-point.|||||
32846|NCT01557322|Primary|Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60|The pain VAS is a horizontal line; 100 millimeter (mm) in length, self-administered by the participant to rate pain from 0 mm (no pain) to 100 mm (worst possible pain).Change = mean scores at observation minus mean scores at baseline.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
32847|NCT01557322|Primary|Time to Therapeutic Goal|Therapeutic goal achievement was based on physician’s discretion.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
32848|NCT01557322|Primary|Time to Disease Worsening|Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
32849|NCT01557322|Primary|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.|||||
32850|NCT01557322|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
32851|NCT01557322|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
32852|NCT01557322|Primary|Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs)|Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline.||participants|||Number
32853|NCT01557322|Primary|Time Since Recalled Symptom Onset|RA symptoms include joint pain, stiffness, and swelling.|Baseline|Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis.|||||
32854|NCT01557322|Primary|Time Since First Rheumatologist Visit||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||years||Standard Error|Mean
32855|NCT01557322|Primary|Duration of Disease (Rheumatoid Arthritis)||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||years||Standard Error|Mean
32856|NCT01557322|Primary|Change From Baseline in Patient’s Global Assessment (PtGA) of Disease Activity at Month 60|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||mm||Standard Error|Mean
32857|NCT01557322|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||mm/hour||Standard Error|Mean
32858|NCT01557322|Primary|Change From Baseline in C-Reactive Protein (CRP) Level at Month 60|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is <10 milligram/liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||mg/L||Standard Error|Mean
32859|NCT01557322|Primary|Change From Baseline in Swollen Joints Count (SJC) at Month 60|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||swollen joints||Standard Error|Mean
32860|NCT01557322|Primary|Change From Baseline in Tender Joints Count (TJC) at Month 60|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||tender joints||Standard Error|Mean
32861|NCT01557322|Primary|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, acute phase reactants (erythrocyte sedimentation rate [ESR, millimeters per hour] or C-reactive protein [CRP, milligram per liter]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Error|Mean
32862|NCT01557322|Primary|Blood Pressure (BP)|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively."||millimeter of mercury (mmHg)||Standard Error|Mean
32863|NCT01557322|Primary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||kg/m^2||Standard Error|Mean
32864|NCT01557322|Primary|Number of Participants With Comorbidities|Comorbidities included: hypertension, moderate or severe heart failure, angina, stroke, epilepsy, asthma, chronic bronchitis/emphysema, peptic ulcer, tuberculosis, pre-existing or recent onset of central nervous system demyelinating disorders, chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis, active tuberculosis, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease, malignancy or history of malignancy, hyperthyroidism, depression and/or anxiety, recent substance abuse (drug or alcohol), human immunodeficiency virus (HIV) infection or active hepatitis B/C infection (including associated chronic active hepatitis). Participants suffering from any of the comorbidity are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
32865|NCT01557322|Primary|Number of Participants With Chest X-Ray Prior to New Therapy||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
32866|NCT01557322|Primary|Number of Participants With Prior Joint Replacement or Surgery|Participants who had prior total knee replacement, total hip replacement, total shoulder replacement, total elbow replacement, wrist/hand/ankle/foot surgery, and neck surgery are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
32867|NCT01557322|Primary|Number of Participants With Systemic Features|Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified).|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.||participants|||Number
32868|NCT01557322|Primary|Number of Participants With American College of Rheumatology (ACR) Criteria|ACR criteria: 1) Morning stiffness: in and around joints, lasting at least (>=) 1 hour; 2) Arthritis/deformity of >=3 joint areas: presence of soft tissue swelling or fluid (not bony overgrowth alone), 14 possible areas are right/left proximal interphalangeal (PIP), metacarpophalangeal (MCP), wrist, elbow, knee, ankle, metatarsophalangeal (MTP) joints; 3) Arthritis of hand joints: >=1 area swollen in wrist, MCP, PIP joint; 4) Symmetric arthritis: simultaneous involvement of same joint areas (as defined in 2) on both sides of body; 5): Rheumatoid nodules: subcutaneous nodules over bony prominences or extensor surfaces or in juxtaarticular regions; 6): Rheumatoid factor (RF): abnormal amounts of RF by any method for which result has been positive in <5% of normal control participants; 7) Radiographic changes: typical of RA on posteroanterior hand and wrist radiographs, which must include erosions/unequivocal bony decalcification localized in or most marked adjacent to involved joints.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
32869|NCT01557283|Other Pre-specified|Number of Participants Who Received Intermittent Treatment|Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
32870|NCT01557283|Other Pre-specified|Number of Participants Who Received Continuous Treatment|Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist’s discretion was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
32871|NCT01557283|Secondary|Number of Participants With Reasons for Treatmant Discontinuation|Number of participants who discontinued etanercept before completing the study was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.||participants|||Number
32872|NCT01557283|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.||percentage of BSA||Standard Deviation|Mean
32873|NCT01557283|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
32874|NCT01557283|Secondary|Number of Weeks of Off-Treatment|Total duration of time in weeks for which participants discontinued etanercept treatment was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||weeks||Standard Deviation|Mean
32875|NCT01557283|Primary|Number of Weeks of Etanercept Treatment|Average duration of time in weeks for treatment with etanercept was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.||weeks||Standard Deviation|Mean
32876|NCT01557166|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 345 subjects contributed to the statistical analysis||percentage of glycosylated haemoglobin||Standard Deviation|Mean
32877|NCT01557166|Secondary|Change From Baseline in Fasting Plasma Glucose|Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 355 subjects contributed to the statistical analysis.||mmol/L||Standard Deviation|Mean
32878|NCT01557166|Secondary|Change From Baseline in Body Weight (kg)|Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 353 subjects contributed to the statistical analysis.||kg||Standard Deviation|Mean
32879|NCT01557166|Primary|Change From Baseline in Apnoea-hypopnoea Index (AHI)|Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0−14.9; moderate 15.0−29.9; severe ≥30.0 events/hour.|Week 0, Week 32|Full analysis set (FAS) - included all randomised subjects. 334 subjects contributed to the statistical analysis.||events/hour||Standard Deviation|Mean
32882|NCT01556932|Primary|The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.|The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a “prn” (as needed) gel in actual practice, when relief is needed in short order.|60 minutes after application|25 participants were consented, two subjects declined treatment, one expired subject. Two subjects refused to continue after first treatment and did not complete the second treatment. Only 20 patients were analyzed because of missing data not done by those two subjects on the second treatment.||units on a scale||Standard Deviation|Mean
32883|NCT01556906|Secondary|Absolute Change From Baseline in Linoleic Acid (LA)|Absolute Change From Baseline in LA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
32884|NCT01556906|Secondary|Absolute Change From Baseline in Docosahexaenoic Acid (DHA)|Absolute Change From Baseline in DHA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
32885|NCT01556906|Secondary|Absolute Change From Baseline in Eicosapentaenoic Acid (EPA)|Absolute Change From Baseline in EPA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
32886|NCT01556906|Secondary|Absolute Change From Baseline in Alpha Linoleic Acid (ALA)|Absolute Change From Baseline in ALA|Baseline and 16 weeks of treatment|All patients treated||mg/mL||Standard Deviation|Mean
32887|NCT01556906|Secondary|Absolute Change From Baseline in Ratio of Vitamin E to Total Lipids|Absolute Change From Baseline in ratio of vitamin E to total lipids|Baseline and 16 weeks of treatment|All patients treated||ratio||Standard Deviation|Mean
32888|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin D|Absolute Change From Baseline in Vitamin D|Baseline and 16 weeks of treatment|All patients treated||nmol/L||Standard Deviation|Mean
32889|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin E|Absolute change from Baseline in vitamin E|Baseline and 16 weeks of treatment|All patients treated||umol/L||Standard Deviation|Mean
32890|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin A|Absolute change from Baseline in vitamin A|Baseline and 16 weeks of treatment|All patients treated||µmol/L||Standard Deviation|Mean
32891|NCT01556906|Secondary|Absolute Change From Baseline in Carbon Monoxide Lung Diffusing Capacity (DLCO)(a Pulmonary Function Test)|Absolute change from Baseline in DLCO|Baseline and 16 weeks of treatment|All patients treated||mL CO/min/mm Hg||Standard Deviation|Mean
32892|NCT01556906|Secondary|Absolute Change From Baseline in Forced Expiratory Volume During 1 Second (FEV1)|Absolute change from Baseline in FEV1|Baseline and 16 weeks of treatment|All patients treated||Liters||Standard Deviation|Mean
32893|NCT01556906|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and 16 weeks of treatment|All patients treated||percent of hapatic fat||Standard Deviation|Mean
32894|NCT01556906|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and 16 weeks of treatment|All patients treated||mg/dL||Standard Deviation|Mean
32895|NCT01556906|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and 16 weeks of treatment|All patients treated||U/L||Standard Deviation|Mean
32896|NCT01556906|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and 16 weeks of treatment|All patients treated||U/L||Standard Deviation|Mean
32897|NCT01556906|Primary|LDL-C|Percent change in LDL-C compared to Baseline.|Up to 16 weeks of treatment comapred to Baseline|All patients treated||percentage change in LDL-C||Standard Deviation|Mean
32898|NCT01556763|Secondary|P300 Peak Amplitude|P300 auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the peak amplitude over 250-500 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -0.4 to 1.2 microvolts. Normalization is suggested by a more positive value.|Days -1 to 20|Subjects providing valid and measurable P300 responses.||microvolts||Standard Error|Mean
32899|NCT01556763|Secondary|MMN Summed Amplitude|Mismatch negativity (MMN) auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the voltage difference over 100-200 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -1.2 to 0.2 microvolts. Normalization is suggested by a more negative value.|Days -1 to 20|Subjects providing valid and measurable MMN responses.||microvolts||Standard Error|Mean
32900|NCT01556763|Secondary|P50 Amplitude Difference|P50 auditory evoked potential response (amplitude measured in microvolts) using sensory gating paradigm. Measured by EEG as amplitude difference (conditioning stimulus minus test stimulus). Plotted on a scale of -0.2 to 0.8 microvolts. Normalization is suggested by a higher value.|Days -1 to 20|Subjects providing valid and measurable P50 responses.||microvolts||Standard Error|Mean
32901|NCT01556763|Secondary|N100 Gating Ratio|N100 auditory evoked potential response (amplitude measured in microvolts) using the sensory gating paradigm. Measured by electroencephalography (EEG) as the amplitude ratio of test stimulus to conditioning stimulus. Plotted on a unitless scale of 0 to 2. Normalization is suggested by a lower value.|Days -1 to 20|Subjects providing valid and measurable N100 responses.||ratio||Standard Error|Mean
32902|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving paliperidone/risperidone for whom blood samples were available for analysis.||hr||Standard Deviation|Mean
32903|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.||pg*hr/ml||Standard Deviation|Mean
32904|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.||hr||Full Range|Median
32910|NCT01556763|Primary|Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.|Safety and tolerability was measured by number of reported adverse events (serious and non-serious) and repeated clinical evaluation of physical examinations, vital signs, 12-lead electrocardiogram (ECG), 24-hour continuous cardiac monitoring, and laboratory tests (hematology/blood chemistry/urinalysis).|Screening (Day -5 for continuous cardiac monitoring) to Day 22|All randomized patients who ingested at least one dose of study drug or placebo.||participants|||Number
32911|NCT01555463|Secondary|Change From Baseline in Index Value at End of Treatment|The EuroQol Group Questionnaire–5 Dimensions–5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: “no problems” (level 1), “slight problems” (level 2), “moderate problems” (level 3), “severe problems” (level 4), and “extreme problems” (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Scores on a scale||Full Range|Median
32912|NCT01555463|Secondary|Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment|"The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented."|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Scores on a scale||Full Range|Median
32913|NCT01555463|Secondary|Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score|The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant’s skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: “very much” (question 7: “yes”) (score=3), “a lot” (score=2), “a little” (score=1), or “not at all”/”not relevant” (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment – baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
32914|NCT01555463|Secondary|Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score|The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant’s quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are “never” (score=1), “rarely” (score=2), “sometimes” (score=3), “often” (score=4), or “all the time” (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Scores on a scale||Standard Deviation|Mean
32915|NCT01555463|Secondary|Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment|At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
32916|NCT01555463|Secondary|Participants' Opinion on Cosmetic Acceptability at End of Treatment|At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
32917|NCT01555463|Secondary|Participants' Global Assessment of Tolerability at End of Treatment|At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
32918|NCT01555463|Secondary|Participants' Global Assessment of Treatment Response at End of Treatment|At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.||Participants|||Number
41843|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|3 years||||||
32919|NCT01555463|Secondary|Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)|Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
32920|NCT01555463|Secondary|Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)|Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an ‘improved’ telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, ‘no change’ if the rating was identical, and ‘worsened’ if the rating was higher. The percentage of participants in each category is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
32921|NCT01555463|Secondary|Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)|The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
32922|NCT01555463|Secondary|Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) lesion count at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Inflammatory lesions||Standard Deviation|Mean
32923|NCT01555463|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Scores at End of Treatment (LOCF)|The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
32924|NCT01555463|Secondary|Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)|Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into ‘improved’, ‘no change’, or ‘worsened’. A participant was considered to have an ‘improved’ erythema rating if the erythema rating was lower compared to the baseline rating, ‘no change’ if the rating was identical, and ‘worsened’ if the rating was higher. The percentage of participants in each of these categories is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
32925|NCT01555463|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)|Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as ‘responder’. Participants with an IGA of moderate or severe at the end of treatment were considered as ‘non-responder’. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as ‘non-responders’. The percentage of responders is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
32926|NCT01555463|Secondary|Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percent change of inflammatory lesions||Standard Deviation|Mean
32927|NCT01555463|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)|The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Inflammatory lesions||Standard Deviation|Mean
32928|NCT01555463|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.||Percentage of participants|||Number
32929|NCT01556724|Secondary|Decreased Infusion Rates|Number of patient requiring decreased infusion rates due to increased motor blockade|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)||||||
32934|NCT01556633|Secondary|Number of Participants With Abnormal Shifts in Vital Signs|"Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature.~Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as <=70 mmHg (SBP) and <=40 mmHg (DBP); high blood pressure defined as >=140 mmHg (SBP) and >=90 mmHg (DBP); low temperature defined as <=36.5 degrees Celsius and high temperature defined as >=37.5 degrees Celsius."|Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
32935|NCT01556633|Secondary|Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit|ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond [msec]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as <=30, >30-60, and >60 msec increase from baseline.|From Baseline (Day -1) to Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
32936|NCT01556633|Secondary|Number of Participants With Marked Abnormality in Laboratory Measurements|"Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase [ALT], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis.~Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L."|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
32937|NCT01556633|Primary|Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate|CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t).|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine.|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||L/h||Geometric Coefficient of Variation|Geometric Mean
32938|NCT01556633|Primary|Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate|"The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration.~The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||h||Full Range|Median
32939|NCT01556633|Primary|C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration.~Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis.||ng/mL||Standard Deviation|Mean
32940|NCT01556633|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
32941|NCT01556633|Primary|AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose|AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
32955|NCT01556165|Secondary|Time to Onset of Levodopa Therapy|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26||||||
32942|NCT01556633|Primary|AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."||nanogram (ng)*h/ milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
32943|NCT01556633|Secondary|Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.||participants|||Number
32944|NCT01556633|Primary|Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose.~CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed[0-48])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC[0-48])~CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed[0-8]/AUC[0-8] + Aed[24-32]/AUC[24-32]) / 2~CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed[8-16]/AUC[8-16] + Aed[16-24]/AUC[16-24] + Aed[32-48]/AUC[32-48]) / 3"|CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood|Pharmacokinetic (PK) population: Only 9 participants were included for this analysis as they did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or if data was unavailable or incomplete which influence the PK analysis were excluded from the PK analysis population.||Litre (L)/hour (h)||Geometric Coefficient of Variation|Geometric Mean
32945|NCT01556594|Secondary|Mean Peak Plasma Concentration (Cmax) of Glucose|mean plasma glucose level after treatment with test article|Samples were obtained at 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All subjects treated were analyzed||mmol/L||Standard Error|Mean
32946|NCT01556594|Primary|Participants With at Least One Adverse Event|Safety and tolerability will be evaluated through the assessment of adverse events, physical examination, laboratory tests, vital signs and ECG.|Safety evaluations were recorded from dosing up until 3 hours after dosing with test medication|All patients who were treated were included in the analysis||participants with at least one AE|||Number
32947|NCT01556594|Primary|Percentage of Responders|A responder will be defined as a subject who achieved normal blood glucose ( ≥3.8 mmol/L) within 30 minutes after treatment.|Within 30 minutes of treatment with test article|All subjects were included in the analysis||percentage of patients treated|||Number
32948|NCT01556451|Primary|Percentage of Participants Discontinued Due to Clinical Adverse Experiences||Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up||Percentage of Participants|||Number
32949|NCT01556451|Primary|Percentage of Participants With Clinical Adverse Experiences|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up||Percentage of Participants|||Number
32950|NCT01556451|Primary|Geometric Mean Titer (GMT) of VZV Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV|Day 1 (Baseline) and 4 weeks postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures||gpELISA units/mL||95% Confidence Interval|Geometric Mean
32951|NCT01556451|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).|Day 1 (Baseline) and Week 4 postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures||Ratio||95% Confidence Interval|Geometric Mean
32952|NCT01556204|Secondary|Pain|Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.|Baseline, 6-weeks, 6-months|||units on a scale||Standard Deviation|Mean
32953|NCT01556204|Primary|Operative Time|Operative time is defined as skin incision to skin closure.|1st 24 hours|||minutes||Standard Deviation|Mean
32954|NCT01556165|Secondary|Levodopa Administration Within 26 Weeks|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26||||||
32956|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
32957|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
32958|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
32959|NCT01556165|Primary|Change From Baseline to Week 26 in UPDRS Total Score|The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson’s disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.||units on a scale||Standard Error|Mean
32960|NCT01556061|Secondary|Second Laryngoscopy|A second laryngoscopy will be performed in patients with the video laryngoscope from the other group. Patients will be intubated after second laryngoscopy with with this same video laryngoscope.|30 seconds|||seconds||Inter-Quartile Range|Median
32961|NCT01556061|Secondary|First Laryngoscopy|Patients underwent laryngoscopy first with their assigned randomized laryngoscope. Time measured was from the time from the moment the anesthesiologist had the laryngoscope in hand to time to optimal visualization of vocal cords.|30 seconds|||seconds||Inter-Quartile Range|Median
32962|NCT01556061|Primary|Time for Intubation|Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.|90 seconds|The unit of measure of time in seconds from D-MAC larynogoscopy to intubation in the (C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy) group and from C-MAC laryngoscopy to intubation in the (D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy) group.||seconds||Inter-Quartile Range|Median
32963|NCT01555983|Primary|Number of Participants Achieving a Reduction in Pain Intensity of 30% or More|Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.|hourly pain assessments for 8 hours|||participants|||Number
32964|NCT01555931|Secondary|LNG-IUS Expulsion or Removal|Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study|up to 6 months|||participants|||Number
32965|NCT01555931|Primary|Breastfeeding|Reported any breastfeeding at the final 6 month visit|6 months|||participants|||Number
32966|NCT01555164|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations; analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
32967|NCT01555164|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
32968|NCT01555164|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations, and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.||percent of HbA1c in blood||Standard Deviation|Mean
32969|NCT01555151|Secondary|Plasma Cortisol Concentrations|Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L|Baseline, days 1 and 28|The safety set includes all subjects who received at least one dose of study drug.||nmol/L||Standard Deviation|Mean
32970|NCT01555151|Secondary|Fractional Exhaled Nitric Oxide (FeNO)|FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.|Days 15 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||ppm||Standard Error|Mean
32981|NCT01555138|Secondary|Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'|A ‘day with no rescue use’ is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of ‘days with no rescue use’ will be derived and analyzed as for the percentage of ‘nights with no nighttime awakenings’.|26 weeks|Full Analysis Set||% of Days||Standard Error|Least Squares Mean
33073|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
32971|NCT01555151|Secondary|Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment|"Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.~A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.~The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use."|4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||percentage days||Standard Error|Least Squares Mean
32972|NCT01555151|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment|Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Baseline and 4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||number of puffs||Standard Error|Least Squares Mean
32973|NCT01555151|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).|Baseline, days 8,15,22 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Units on a scale||Standard Error|Least Squares Mean
32974|NCT01555151|Secondary|Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment|Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.|Baseline and week 4|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters per min||Standard Error|Least Squares Mean
32975|NCT01555151|Secondary|Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Percent||Standard Error|Least Squares Mean
32976|NCT01555151|Secondary|Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters per second||Standard Error|Least Squares Mean
32977|NCT01555151|Secondary|Forced Vital Capacity (FVC) at All Time Points|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters||Standard Error|Least Squares Mean
32978|NCT01555151|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 8, 15 and 22|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters||Standard Error|Least Squares Mean
32979|NCT01555151|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.|Day 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.||Liters||Standard Error|Least Squares Mean
32980|NCT01555138|Secondary|St Georges Respiratory Questionnaire for COPD|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|12 and 26 weeks|Full Analysis set||scores on a scale||Standard Error|Least Squares Mean
41844|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|2 years||||||
32982|NCT01555138|Secondary|Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment|The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.|12 and 26 weeks|||number of puffs||Standard Deviation|Mean
32983|NCT01555138|Secondary|Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)|The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks|||participants|||Number
32984|NCT01555138|Secondary|TDI Focal Score at Week 12 and Week 26: Treatment Comparisons|The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.|12 and 26 weeks|||Units on a scale||Standard Error|Least Squares Mean
32985|NCT01555138|Secondary|Analysis of AUC (5 Min – 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison|The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.|12 and 26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
32986|NCT01555138|Secondary|FVC Over 26 Weeks of Treatment|FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 and 26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
32987|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .|26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
32988|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
32989|NCT01555138|Secondary|Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons|Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.|26 weeks|Full analysis set||Liters||Standard Error|Least Squares Mean
32990|NCT01555138|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons|Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.|12 weeks|full analysis set||Liters||Standard Error|Least Squares Mean
32991|NCT01555073|Secondary|Quality of Life|To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months|||||
32992|NCT01555073|Primary|Post Operative Pain Control|To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months|||||
32993|NCT01554982|Other Pre-specified|IV Iron Use|Percent of subjects with No IV iron intake from first dose of study drug to Week 48|48 weeks|||percentage of participants|||Number
32994|NCT01554982|Other Pre-specified|Hemoglobin- Week 48||48 weeks|||g/dL||Standard Deviation|Mean
32995|NCT01554982|Other Pre-specified|Hemoglobin- Baseline||Baseline|||g/dL||Standard Deviation|Mean
32996|NCT01554982|Other Pre-specified|TSAT- Week 48||48 weeks|||percentage of saturation||Standard Deviation|Mean
32997|NCT01554982|Other Pre-specified|Transferrin Saturation (TSAT) - Baseline||Baseline|||percentage of saturation||Standard Deviation|Mean
32998|NCT01554982|Other Pre-specified|Ferritin- Week 48||48 weeks|||ng/mL||Standard Deviation|Mean
32999|NCT01554982|Other Pre-specified|Ferritin- Baseline||Baseline|||ng/mL||Standard Deviation|Mean
33000|NCT01554982|Other Pre-specified|Serum Phosphorus- Week 48||48 weeks|||mg/dL||Standard Deviation|Mean
33001|NCT01554982|Other Pre-specified|Serum Phosphorus- Baseline||Baseline|||mg/dL||Standard Deviation|Mean
33002|NCT01554982|Primary|Safety Parameters|Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).|48 Weeks|Safety Population; Treatment Emergent Adverse Events (TEAEs), not including SAEs, reported include only those occurring at a frequency >5%||participants|||Number
33003|NCT01554904|Secondary|Apnea-Hypopnea Index (AHI)|The number of apneas and hypopneas per hour of monitoring|baseline and after 6 weeks of facial muscle training|Participants completing 6 weeks of training and second sleep study||events per hour||Standard Deviation|Mean
33040|NCT01553539|Primary|Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|See the adverse event tables for specifics.|Approximately 1 year|||Participants experiencing adverse events|||Number
33109|NCT01552694|Primary|Inflammatory Biomarker 1: Plasma hsCRP Concentration|Fasting serum and plasma samples obtained at baseline and week 8 are batched for ELISA analysis (end of sudy) of hsCRP, IL-6 and D-dimer concentrations.|2 months|||mg/L||Standard Deviation|Mean
33004|NCT01554904|Primary|Snore Index|The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device [Sleep Scout (ClevMed, Cleveland Ohio)] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).|baseline and after 6 weeks of facial muscle training|Subjects completing 6 weeks of training and Home Sleep Test # 2||snores per hour of monitoring||Standard Deviation|Mean
33005|NCT01554891|Primary|Sensitivity and Specificity of the SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI|6-months after medical evacuation|Data were only collected for cohort 3.||percentage|||Number
33006|NCT01554891|Primary|Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.|Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2) Cohort 2: The primary endpoint for this sub-study is the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen. (Speciﬁc Aim 2).|baseline|Analyses done for Cohort 2 only.||percentage of participants||95% Confidence Interval|Number
33007|NCT01554891|Primary|Test-retest Reliability SAFE-TBI|Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1) Cohort 1: The primary endpoints for this sub-study (cohort) are the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks) as well as the two rater types TRC vs. TBIC. (Speciﬁc Aim 1).|Up to 6 weeks|Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview.||kappa (reliability)||95% Confidence Interval|Number
33008|NCT01554241|Secondary|Free 25-OH Vitamin D3|circulating free 25-OH vitamin D3 concentration|16 weeks|||pg/mL||Standard Deviation|Mean
33009|NCT01554241|Primary|Total 25-OH Vitamin D3 Level|circulating total 25-OH vitamin D concentration|16 weeks|||ng/mL||Standard Deviation|Mean
33010|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.|From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
33011|NCT01554176|Primary|Number of Participants With an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.|From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
33012|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
33013|NCT01554176|Primary|Number of Participants With an Adverse Event (AE) During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.||Participants|||Number
33014|NCT01554176|Secondary|Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 54. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. A participant with HAM-D17 total score ≤7 at Week 6 of the Treatment Phase was defined to have achieved HAM-D17 remission.|Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 score.||percentage of participants|||Number
41908|NCT01434823|Secondary|Daytime Intensivist Daily Sleep Duration|This will be the primary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
33015|NCT01554176|Secondary|Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). The Bech subscale of the HAM-D17 is composed of 6 identified items out of the 17 items rated. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 22. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). The reported measure is the change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 Beck Subscale score.||score on a scale||Standard Deviation|Mean
33016|NCT01554176|Secondary|Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item|"The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. This measure considered 9 of the 10 MADRS items: apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. It excluded reduced sleep. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values."|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 MADRS score.||score on a scale||Standard Deviation|Mean
33017|NCT01554176|Primary|Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 value.||score on a scale||Standard Deviation|Mean
33018|NCT01554163|Secondary|Time-Weighted Mean Response on the Investigator Global Assessment of Response to Therapy|Study investigators were asked to rate the global assessment of participant response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a value at Week 6 and Week 12 for the Investigator Global Assessment of Response to Therapy.||Score on a Scale||Standard Error|Least Squares Mean
33019|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Stiffness Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The stiffness subscale rates stiffness after first waking and later in the day using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of stiffness and 100 is the highest level of stiffness. The stiffness subscale is calculated as the average of the responses to the 2 questions related to stiffness. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all paricipants that received one dose of study medication and had a baseline value for the WOMAC stiffness subscale, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
33020|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Investigator Global Assessment of Disease Status|Study investigators were asked to rate the global assessment of participant disease status on a Likert scale from 0 to 4, with 0 = very well, 1 = good, 2 = fair, 3 = poor and 4 = very poor. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Investigator Global Assessment of Disease Status, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
33021|NCT01554163|Secondary|Time-Weighted Mean Response in the Participant Global Assessment of Response to Therapy|Participants were asked to rate their global assessment of response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a Week 2, Week 6, and Week 12 value for the Participant Global Assessment of Response to Therapy.||Score on a Scale||Standard Error|Least Squares Mean
33022|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Participant Global Assessment of Disease Status|The Participant Global Assessmet of Disease was a one item questionnaire that asked participants to answer the following question, “Considering all the ways your arthritis affects you, mark (X) on the scale for how well you are doing.” The questionnaire employed a 0-100 mm visual analog scale (VAS) to record participant responses, with 0 representing the best possible assessment and 100 representing the worst possible assessment. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Participant Global Assessment of Disease Status, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
41909|NCT01434823|Secondary|Discharge Home From Hospital|Patients who were discharged from the hospital to their homes|Assessed up to 12 months|||participants|||Number
33023|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of functioning and 100 is the highest level of functioning. The physical function subscale was calculated as the average of the responses to the 17 questions related to functional status. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC physical function subscale, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
33024|NCT01554163|Primary|Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC pain subscale, and had at least one post-randomization observation.||Score on a Scale||Standard Error|Least Squares Mean
33025|NCT01553851|Secondary|Percent of Participants With Metabolic Changes in OCSCC Using FDG-PET/CT Imaging.|Intratumarol metabolic changes were evaluated by changes in in SUVmax in the primary tumor; quantitative analysis SUVmax with the primary tumor site was determined within a volume of interest around the tumor using a Siemens eSoft workstation.|Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)||percentage of participants|||Number
33026|NCT01553851|Secondary|Percent Change in Tumor Size Area||Baseline and Day 15|Quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.||percent change in tumor size area||Full Range|Median
33027|NCT01553851|Secondary|Safety of GSK1120212|Number of adverse events were monitored for 30 day following last dose of GSK1120212|1st 4-6 week follow-up visit|||Adverse events|||Number
33028|NCT01553851|Secondary|Percent Change in Maximum Standard Uptake Value in Oral Cavity Saqumous Cell Carcinoma (OCSCC) Using F18-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT).||Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)||percentage change in SUVmax||Full Range|Median
33029|NCT01553851|Secondary|Flow Cytometric Analysis of the Peripheral Blood and Tumor.|"Peripheral blood - baseline and Day 14~Tumor - baseline and Day 15"|Baseline, Day 14, and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.|||||
33030|NCT01553851|Secondary|Percentage of Participants With Clinical Response Induced by GSK1120212, as Determined by Change in Tumor Size.|Clinical Response was evaluted by quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.|Baseline and Day 15|||percentage of participants|||Number
33031|NCT01553851|Secondary|Tumor Specific Findings for Pathologic Changes Including Proliferation (Ki-67 Staining), Tumor Vasculature Staining (Microvessel Density), ERK1/2 Mediated Changes in p27 (Kip1) & Flow Cytometric Analysis of the Peripheral Blood & Tumor.||Baseline and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.|||||
33032|NCT01553851|Primary|Number of Participants With Changes in TumorCell Surface CD44 Expression After Treatment With GSK1120212.|Pre-post measure of CD44 expression using IHC.|Baseline and Day 15|||Participants|||Number
33033|NCT01553851|Primary|Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.|Pre-post measure of p-EKP expression was measured by change in staining intensity and quartile distribution.|Baseline and Day 15|Only15 of the 17 participants had sufficient pre- and post-treatment biopsies with sufficient tumor content to be evaluated for this biomarker assessment.||participants|||Number
33034|NCT01553708|Secondary|Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.|"Pain and itching assessment is evaluated by patients themselves in every time of wound observations using Visual Analog Scale.~% Wound contraction.~Time and type of analgesic or itching medication after treatment.~Laboratory measurement such as CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes or any systemic effect after treatment.~Adverse reaction such as swelling, edema and redness at wound site."|On 28th day after admission||||||
33035|NCT01553708|Primary|Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).|Time (days)for complete epithelialization (no open wound exists as determined by 2 surgeons) is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.|On 28th day after admission|||Days||Standard Deviation|Mean
33036|NCT01553539|Secondary|Plasma Levels of Angiogenic Peptides Including PIGF||Day 22||||||
33037|NCT01553539|Secondary|Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)||Day 1||||||
33038|NCT01553539|Secondary|Overall Survival||Approximately 5 years||||||
33039|NCT01553539|Secondary|Time to Disease Progression||Approximately 5 years||||||
33041|NCT01553539|Primary|Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response|'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria) among all evaluable patients.|Approximately 1 year|||participants|||Number
33042|NCT01553318|Secondary|Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10|Change in peripheral blood levels of IL-8, MCP-1 and Eotaxin from baseline to week 10|baseline and week10|We do not have data on the chemokines because of the problems we had with the assays. Indeed, IL-8, MCP-1 and Eotaxin were all secondary outcomes.|||||
33043|NCT01553318|Secondary|Fibromyalgia Impact Questionnaire|Change in global symptom severity [scale range from -100 to +100] = the more negative the value is, the greater the improvement in overall symptom severity|baseline and week 10|Indeed, fibromyalgia impact questionnaire is a secondary outcome.||units on a scale||Standard Deviation|Mean
33044|NCT01553318|Secondary|Change From Baseline in Evoked Pain Score at Week 10|Change in evoked pain score from baseline to week 10 (scale range -20 to +20): interpretation= the more negative the value is, the larger the reduction in sensitivity to pressure pain stimuli|baseline and week 10|||units on a scale||Standard Deviation|Mean
33045|NCT01553318|Primary|Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10|Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is|baseline and week 10|||units on a scale||Standard Deviation|Mean
33046|NCT01553292|Secondary|Needs for Intubation During the Procedure|The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)|10 minutes|The number of preterm infants that needed intubation by ETT (endotracheal intubation) during ECALMIST||Number of participants|||Number
33047|NCT01553292|Secondary|Oxygen Requirements After the Procedure|Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100. The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.|4 hours|The mean of oxygen level (proportion) of all participant after ECALMIST||Proportion of oxygen saturation||Standard Deviation|Mean
33048|NCT01553292|Secondary|Oxygen Saturation Before the Procedure|Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of saturation of all participants before ECALMIST||Proportion of oxygen saturation||Standard Deviation|Mean
33049|NCT01553292|Secondary|CPAP Pressure Before the Proceudre|Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)|1 hour|The mean of CPAP pressure that is measured by centimeter of water of all the participant before ECALMIST||Centimeter of water||Standard Deviation|Mean
33050|NCT01553292|Secondary|Index After the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.~FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|4 hours|The mean of ECALMIST index of all the participants after ECALMIST||Score||Standard Deviation|Mean
33051|NCT01553292|Secondary|Oxygen Saturation After the Procedure|Oxygen saturation is measured by pulse oximetry. It is express as proportion out of 1 (decimal) that is equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|4 hours|The mean of oxygen saturation after ECALMIST for all the participants||Proportion of oxygen saturation||Standard Deviation|Mean
33052|NCT01553292|Secondary|Oxygen Requirement Before the Procedure|Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of oxygen requirement of all the participants before ECALMIST||Proportion of oxygen requirement||Standard Deviation|Mean
33053|NCT01553292|Secondary|CPAP Pressure After the Procedure|Continuous positive airway pressure (CPAP) is measured in centimeter of water|4 hours|The mean of CPAP pressure express as centimeter of water of all participants after completion of ECALMIST||Centimeter of water||Standard Deviation|Mean
33054|NCT01553292|Secondary|Index Before the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.~FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|1 hour|The mean of index of all participants before ECALMIST||Score||Standard Deviation|Mean
33055|NCT01553292|Primary|Incidence of Early Ventilation Hours|The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing|72 hours|The number of preterm infants that need intubation by ETT within 72 hours of life(early ventilation). This is includes all infants intubated whether during or after the ECALMIST procedure in the 1st 3 days of life (after delivery)||Number of participants|||Number
33056|NCT01553292|Secondary|Failure to Catheterized the Trachea by the Vascular Catheter|Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.|20 seconds|Number of infatns that failed to pass the angiocath to the trachea after 2 trials, 20 seconds each trial.||Number of participants|||Number
33057|NCT01553292|Secondary|Saturation During the Procedure|Level of oxygen which is measured by oxygen pulse Oximetry. It is express as proportion out of one which is equal to percentage of 100. The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.|10 minutes|The mean of oxygen saturation of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)||Proportion of oxygen saturation||Standard Deviation|Mean
33072|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
33058|NCT01553292|Secondary|Incidence of Bradycardia During Procedure|Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.|Range of 10 minutes|The mean of heart beat per minute of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)||Number of participants|||Number
33059|NCT01553240|Secondary|Vineland Maladaptive Behavior Scale||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
33060|NCT01553240|Primary|Repetitive Behavior Scale-revised||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
33061|NCT01552954|Secondary|Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16|Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16 in the Intensive Education Group compared to the Conventional Education Group|week 8 and week 16|||mm Hg||Standard Deviation|Mean
33062|NCT01552954|Secondary|Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16|Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet at week 16|week 8 and week 16|||mEq/day||Standard Deviation|Mean
33063|NCT01552954|Secondary|∆Hemoglobin (0 Week - 16 Weeks)|The change of hemoglobin after prescription of Olmesartan|0 week, 16 weeks|||g/dL||Standard Deviation|Mean
33064|NCT01552954|Primary|∆Albuminuria by 24-hour Urine Protein Excretion|"Change in albuminuria as a 24-hour urine protein excretion by intensive education of low salt diet during taking olmesartan~*In outcome measure data table, the 24-hour urine collection at 16th week was omitted in 3 out of 245 patients (1 for intensive education group and 2 for conventional education group). Values of each study week were “mean” of all participants on specific study week, but “∆albuminuria (week 8 - week 16)” value was “mean” of ∆ values of “8 weeks-16 weeks” in each individuals. Therefore, values of 3 patients were excluded in “mean of ∆albuminuria (week 8 - week 16)”. That's why simple subtraction (week 8 - week 16) of values are not matched with the data."|changes from week 8 at week 16 (week 8 - week 16)|||mg/day||Standard Deviation|Mean
33065|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point|"The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33066|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33067|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33068|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point|The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats per minute||90% Confidence Interval|Least Squares Mean
33069|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33070|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
33071|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.||ng/ml||Standard Deviation|Geometric Mean
33074|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax|The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33075|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33076|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33077|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax||Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats per minute||90% Confidence Interval|Least Squares Mean
33078|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)|QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||90% Confidence Interval|Least Squares Mean
33079|NCT01552915|Secondary|Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.||bpm||Standard Deviation|Mean
33080|NCT01552915|Secondary|Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.||mmHg||Standard Deviation|Mean
33081|NCT01552915|Secondary|Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 Weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.||mmHg||Standard Deviation|Mean
33082|NCT01552915|Secondary|Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.||percentage of participants|||Number
33083|NCT01552915|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.|Baseline and week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
33084|NCT01552902|Other Pre-specified|Change From Baseline in Pulse Rate at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.||Beats per minute||Standard Deviation|Mean
33085|NCT01552902|Other Pre-specified|Change From Baseline in Blood Pressure at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.||millimeter of mercury (mmHg)||Standard Deviation|Mean
33086|NCT01552902|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 3 days after last dose (last dose at Week 6)|Safety set.||participants|||Number
33087|NCT01552902|Secondary|Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6|The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.|Week 6|FAS.||percentage of participants|||Number
33088|NCT01552902|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6|The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.|Baseline, Week 6|Full Analysis Set (FAS) was defined as all participants in the Safety set who had at least 1 post-baseline measurement of the ADHD-RS-IV. Not all FAS participants were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
33089|NCT01552876|Other Pre-specified|Phase II: Absolute Rotation|Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.|1-minute during Phase II|Analysis was on those subjects who were enrolled, randomized, and completed the study.||Degrees|Participants|Standard Deviation|Mean
33090|NCT01552876|Primary|Phase I: Absolute Lens Rotation|Lens orientation position as assessed on a scale of 0-180 on both eyes.|3 min after lens insertion during Phase I|Analysis was on those subjects who were enrolled, randomized, and completed the study.||Degrees|Participants|95% Confidence Interval|Least Squares Mean
33091|NCT01552876|Secondary|Phase I: Number of Blinks Until Settled|Number of blinks for the right eye was counted until lens settling using headcam video.|Baseline to 5 minutes during Phase I|Subjects analyzed are those who were enrolled, randomized, and completed the study.||Blinks||Standard Error|Least Squares Mean
33092|NCT01552876|Secondary|Phase I: Time to Lens Settling|With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.|5 minutes after lens insertion during Phase I|Subjects analyzed were those who were enrolled, randomized, and completed the study.||minutes||95% Confidence Interval|Least Squares Mean
33093|NCT01552876|Primary|Phase I: Absolute Lens Rotation|At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.|At 1-min after lens insertion during Phase I|Subjects included in the analysis were those who were enrolled, randomized, and completed the study.||Degrees|Participants|95% Confidence Interval|Least Squares Mean
33094|NCT01552772|Secondary|CGI-I Scale Score in LOCF Data.|The efficacy of trial medication were rated for each participant using the Clinical Global Impression Improvement (CGI-I) scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
33095|NCT01552772|Secondary|Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
33096|NCT01552772|Secondary|Change From Baseline in CGI-S Score in LOCF Data.|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 1, 2 and 4.|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
33097|NCT01552772|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
33098|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
33099|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for OC Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
33100|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.||Units on a scale||Standard Deviation|Mean
33101|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for OC Data.|The Positive and Negative Syndrome Scale (PANSS) consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
33102|NCT01552772|Secondary|Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety extrapyramidal symptoms (EPS) assessment scales.||Units on a scale||Standard Deviation|Mean
33103|NCT01552772|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).||Units on a scale||Standard Deviation|Mean
33104|NCT01552772|Primary|Number of Participants With Adverse Events (AE).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events.|From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).|The safety analyses dataset consisted of data from all enrolled participants who received one dose of trial medication, regardless of any protocol deviation. All observed data for these participants were included.||Participants|||Number
33105|NCT01552694|Primary|Inflammatory Biomarker 3: Serum D-dimer Concentration|There are 3 levels of the primary outcome measure, hsCRP, IL-6, and D-dimer|2 months|||µg FEU/mL||Standard Deviation|Mean
33106|NCT01552694|Primary|Inflammatory Biomarker 2: Plasma IL-6 Concentration|There are 3 levels of the primary outcome measure; hsCRP, IL-6, and D-dimer concentrations measured at baseline and week 8|2 months|||pg/mL||Standard Deviation|Mean
33107|NCT01552694|Secondary|Blood Endothelial Progenitor Cells|Monocytes are isolated from 20 mL blood. CD34+/VEGFR2+ and CD133+/CD34+/VEGFR2+ monocytes are counted (flow cytometry) and represent markers for endothelial progenitor cell number.|2 months||||||
33108|NCT01552694|Secondary|Adipose Inflammation|Adipose tissue from obese, insulin resistant subjects is characterized by increased macrophage infiltration and overexpression of inflammatory cytokines/chemokines. In obese humans, the presence of CD68+ macrophages in direct contact with mature adipocytes has been noted in histologic sections of adipose tissue, and these appear as a macrophage “crown” around individual adipocytes. In adipocyte sections, we will use positive immunohistochemical staining for CD68 to quantify the density of macrophages and the frequency of “crown’ like structures.|2 months||||||
33110|NCT01552681|Secondary|Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one injection site reaction or Grade 2 or higher adverse event within 24 hours of injection are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.||Percent of participants|||Number
33111|NCT01552681|Secondary|Percent of Participants With Grade 3 or Higher Infection Adverse Event|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher infection adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.||Percent of participants|||Number
33112|NCT01552681|Secondary|Percent of Participants With Adverse Events of Grade 3 or Higher|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.||Percent of participants|||Number
33113|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||units on a scale||Standard Deviation|Mean
33114|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.||units on a scale||Standard Deviation|Mean
33115|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.||units on a scale||Standard Deviation|Mean
33116|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.||units on a scale||Standard Deviation|Mean
33158|NCT01551199|Secondary|Anxiety Disorders Interview Schdule- DSM-IV (ADIS-IV)|The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV crtieria for panic disorder include recurrent unexpected panic attacks and (1) persisent concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.|3 Months|||percentage of participants|||Number
33117|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.||mm/5 min||Standard Deviation|Mean
33118|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.||mm/5 min||Standard Deviation|Mean
33119|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 48. Data were not available for six participants||mm||Standard Deviation|Mean
33120|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 24. Data were not available for six participants||mm||Standard Deviation|Mean
33121|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||mm||Standard Deviation|Mean
33122|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.||mm||Standard Deviation|Mean
33123|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||mm||Standard Deviation|Mean
33124|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.||mm||Standard Deviation|Mean
33219|NCT01549977|Secondary|Change From Baseline in Time to Onset of Angina During ETT at Week 12|The change between the time to onset of angina during the exercise treadmill test (ETT) at Week 12 relative to Baseline.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
33125|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.||Percent of participants|||Number
33126|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and one participant who received placebo.||Percent of participants|||Number
33127|NCT01552681|Secondary|Change From Baseline in European League Against Rheumatism (EULAR) Sjogren’s Syndrome Disease Activity Index (ESSDAI) at Week 24|The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Baseline to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had an ESSDAI score at Baseline and Week 24. Data were not available for five participants who received baminercept and two participants who received placebo.||units on a scale||Standard Deviation|Mean
33128|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 48|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had unstimulated salivary flow results at Screening and Week 48. Data were not available for six participants who received baminercept and one participant who received placebo.||mL/min||Standard Deviation|Mean
33129|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 24|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had an unstimulated salivary flow assessment at screening and week 24. Data were not available for N=7 subjects (e.g., N=5 in baminercept and N=2 in placebo group).||mL/min||Standard Deviation|Mean
33130|NCT01552681|Secondary|Change From Screening in Stimulated Whole Salivary Flow at Week 48|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had stimulated salivary flow results at screening and Week 48. Wk 48 stimulated salivary flow results were not available for N=7 subjects (e.g., N=6 in baminercept and N=1 in placebo group).||mL/min||Standard Deviation|Mean
33145|NCT01552057|Secondary|Clinical Global Impression of Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33756|NCT01541553|Secondary|Partial Clearance of AKs at Week 11|Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11|Week 11|||participants|||Number
33131|NCT01552681|Primary|Change From Screening in Stimulated Whole Salivary Flow at Week 24|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject.||mL/min||Standard Deviation|Mean
33132|NCT01552603|Secondary|Mean Deviation From Target Blood Glucose|Mean difference of venous blood glucose from glucose target. Daytime venous blood glucose values (7am-11pm) subtracted from daytime target of 115 mg/dl. Nighttime venous blood glucose values (11pm-7am) subtracted from nighttime target of 140 mg/dl. This is a metric of how successful the closed loop algorithm was at controlling glucose.|all 28 hour studies|||mg/dl||Standard Deviation|Mean
33133|NCT01552603|Primary|Mean Percent of Time in Target Blood Glucose Range|Mean percent of time venous blood glucose was sampled between 70-180 mg/dl|all 28 hour studies|||percentage of time||Standard Deviation|Mean
33134|NCT01552057|Primary|Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); Last Observation Carried Forward (LOCF) values were used.||units on a scale||Standard Error|Least Squares Mean
33135|NCT01552057|Primary|Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 10 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33136|NCT01552057|Primary|Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33137|NCT01552057|Primary|Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 4 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33138|NCT01552057|Primary|Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33146|NCT01552057|Secondary|Patients Global Impression of Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33239|NCT01549873|Secondary|Amplitude of the SSEPs|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. The amplitude is the voltage of the electrical stimulation recorded.|day of surgery|||microvolt||Standard Deviation|Mean
33139|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33140|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary|Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33141|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33142|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33143|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant’s quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.||units on a scale||Standard Error|Least Squares Mean
33144|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33157|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (dailly/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|3-month follow-up (approximately week 26)|||units on a scale||Standard Deviation|Mean
33147|NCT01552057|Primary|Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).||units on a scale||Standard Error|Least Squares Mean
33148|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg/mL||Standard Deviation|Mean
33149|NCT01551888|Secondary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg*hr/mL||Standard Deviation|Mean
33150|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg/mL||Standard Deviation|Mean
33151|NCT01551888|Primary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters||pg*hr/mL||Standard Deviation|Mean
33152|NCT01551355|Secondary|Body Mass Index - BMI|The body mass index (BMI), or Quetelet index, is a measure of relative weight based on an individual's mass and height = Kg/m²|baseline|||Kg/m²||Standard Deviation|Mean
33153|NCT01551355|Secondary|KAH Score for Teachers|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among teachers after 5 months of intervention as compared to prior to intervention.~Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).~We developed questionnaires to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 37 teachers in healthy habits arm and 35 teachers in usual curriculum arm.||units on a scale||95% Confidence Interval|Mean
33154|NCT01551355|Secondary|KAH Score for Parents|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among parents after 5 months of intervention as compared to prior to intervention.~Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).~Questionnaires were developedheae to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 402 parents in healthy habits arm and 360 parents in usual curriculum arm.||units on a scale||95% Confidence Interval|Mean
33155|NCT01551355|Primary|Change in KAH Score for Children|"Change in weighted knowledge, attitude, habit (KAH) (70/20/10) score among children after 5 months of intervention as compared to prior to intervention.~The study hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, differential weights (70, 20, and 10, respectively) were given to the scores a priori to compose a standardized weighted total score (WTS).~The developed questionnaires measured knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100~Higher values represent a better outcome"|at baseline and at 6 months|"The analysis was done with children that answered al questions in 3 topics: knowledge, attitudes and habits.~Change Score in Weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention."||units on a scale||95% Confidence Interval|Mean
33156|NCT01551303|Primary|Affective Ratings in Affective Learning Task|"We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so better or worse outcome."|30 minutes after drug administration|||units on a scale||Standard Error|Mean
33159|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (dailly/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|1-week post-treatment (approximately week 14)|||units on a scale||Standard Deviation|Mean
33160|NCT01551173|Secondary|Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint|LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels < 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels < 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect.|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit||Percent of participants|||Number
33161|NCT01551173|Secondary|Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit||mmol/L||Standard Error|Mean
33162|NCT01551173|Primary|Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.|Baseline, week 12|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit||Percent change||Standard Error|Mean
33163|NCT01551095|Secondary|Migration of PEGJ Feeding Tube|Risk of retrograde migration within 3 weeks of placement|From date of PEGJ placement up to 3 weeks|||participants|||Number
33164|NCT01551095|Primary|Safety: Number of Participants With Adverse Events|Complications as a result of the PEGJ will be assessed (pain, vomiting, nausea)|From date of PEGJ placement up to 3 weeks|||participants|||Number
33165|NCT01551082|Primary|Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes|Outcome measures for this study were to correlate outpatient chest tube management with patient satisfaction. Also to correlate decreased length of stay without compromising any patient outcomes.|2 years|Study was terminated and no data were collected for the outcome|||||
33166|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of activity impairment||Standard Deviation|Mean
33167|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage|WPAI-SHP is a questionnaire used to assess the effect of the participant’s health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The overall work impairment data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of overall work impairment||Standard Deviation|Mean
33178|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs|UC-related direct and indirect health care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments, medications and indirect costs based on WPAI.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Pound Sterling (GBP)||Standard Deviation|Mean
33431|NCT01545232|Secondary|Ventilator Free Days||first 30 days after ED admission|Number of ventilator free days for each group.||days||Inter-Quartile Range|Median
33168|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of impairment while working data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of impairment while working||Standard Deviation|Mean
33169|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of work time missed data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||percentage of work time missed||Standard Deviation|Mean
33170|NCT01550965|Secondary|Mean Change From Baseline in European Quality of Life – 5 Dimensions – 5 Level (EQ-5D-5L) Total Score|EQ-5D-5L Total Score provides a descriptive profile of health status. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems). A unique EQ-5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from -0.594 to 1, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
33171|NCT01550965|Secondary|Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)|The SCCAI measures disease activity as assessed by the investigator and includes the following 6 items: bowel frequency (day), bowel frequency (night), urgency of defecation, blood in stool, general well-being and extra colonic features. The score ranges from 0 (best) to 19 points (worst).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
33172|NCT01550965|Secondary|Mean Change From Baseline in Physician's Global Assessment (PGA)|The Physician’s Global Assessment was used to measure the participant’s disease activity. The physician considered the participant’s reported information such as number of stools, rectal bleeding, abdominal discomfort, and functional assessment during the previous day prior to the visit, and other observations such as physical findings, and the participant’s performance status at the time of the visit. Based on the above information the investigator made an overall assessment of participant’s current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
33173|NCT01550965|Secondary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
33174|NCT01550965|Secondary|Percentage of Participants With Absence of Blood in Stool|Participants with absence of blood in stool were reported.|Week 26|All participants in the ITT population with evaluable data.||percentage of participants|||Number
33175|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures|UC-related outpatient utilization was determined from the health care utilization information. Outpatient utilization was the number of procedures/surgeries performed during outpatient visits. Participants without any outpatient utilization were excluded.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Procedures/ Surgeries||Standard Deviation|Mean
33176|NCT01550965|Secondary|Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a questionnaire to be completed by the participants to determine their satisfaction of the medications for ulcerative colitis including the study drug. The TSQM is a 14-item subject-rated scale that evaluates the effectiveness, side effects, convenience, and global satisfaction of the medication over the past 2-3 weeks. Each of the 14 questions are scored from 1 (worst) to 7 points (best); and each of the domains are scored from 0 (less satisfaction) to 100 (better satisfaction). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
33177|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization|Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Days||Standard Deviation|Mean
33179|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Pound Sterling (GBP)||Standard Deviation|Mean
33180|NCT01550965|Primary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.||Pound Sterling (GBP)||Standard Deviation|Mean
33181|NCT01550965|Primary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score|The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
33182|NCT01550952|Secondary|Total Oral Opioid Intake in 48hrs|Opioid Usage|0-48hrs|||mg||Standard Deviation|Mean
33183|NCT01550952|Secondary|Numeric Rating Scale (NRS) Pain Scores With Movement|NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.|2 days postoperatively|||units on a scale||Inter-Quartile Range|Median
33184|NCT01550952|Secondary|Number of Participants With Reduced Sensation in a Dermatome|Pin-prick sensation assessed.|2 days postoperatively|Dermatomes could not be assessed for one patient due to sedation||participants|||Number
33185|NCT01550952|Primary|Hand Grip Strength|Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.||percent||Inter-Quartile Range|Median
33186|NCT01550952|Primary|Anterior Deltoid Strength|Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.||percent||Inter-Quartile Range|Median
33187|NCT01550809|Secondary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Above the Threshold of 140 mg/dl (AUC-PG>140).|"The AUC-PG>140 during the 5-hour period following the meal test represents the hyperglycemic risk related to the modality of prandial insulin administration.~Plasma glucose (PG) for calculation of AUC-PG>140 was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. the 5-hour postprandial period|||mg*h/dl||Standard Deviation|Mean
33188|NCT01550809|Primary|The Area Under the Curve (AUC) of the Glucose Infusion Rate (GIR) During the 5-hour Postprandial Period (AUC-GIR0-5h).|"The amount of glucose infused during the 5-hour postprandial period (AUC-GIR0-5h) is a measure of the hypoglycemic exposure associated with the modality of prandial insulin administration. Indeed, glucose will be infused only when patients are under a predefined blood glucose values (80 mg/dl) with a descending trend.~Glucose infusion rate (GIR) for calculation of AUC-GIR was measured every minute following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours.|||mg/kg||Standard Deviation|Mean
33189|NCT01550809|Primary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Concentrations During the 5-hour Postprandial Period (AUC-PG0-5 h).|"AUC-PG0-5 h (5-hour postprandial glucose following the mixed meal test) is a measure of the overall glucose-lowering efficacy of the insulin bolus. The lower the AUC-PG0-5 h without hypoglycemia, the greater the effectiveness of the prandial insulin administration to control the meal related glucose excursion.~Plasma glucose (PG) for calculation of AUC-PG was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours|This was a proof-of-concept study. However, as an estimation of N, a two-sided t-test achieved 84% power to infer that the mean difference was not 0 when the total sample size of a 2x2 crossover design was 12, the actual mean difference in the AUC-PG0-5 h was 100mg*dl-1*h, the square root of the within mean square error was 75.0 and alpha was 0.05.||mg*h/dl||Standard Deviation|Mean
33190|NCT01550744|Secondary|The Percentage of Participants With a PASI 75 Response Over Time|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.||percentage of participants|||Number
33191|NCT01550744|Secondary|The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.||number of visits||Standard Deviation|Mean
33218|NCT01549977|Secondary|Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12|The change between the time to onset of ≥1 mm ST-segment depression during exercise treadmill test (ETT) at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
33192|NCT01550744|Secondary|The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time|Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.||percentage of participants|||Number
33193|NCT01550744|Primary|The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)|Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.||number of visits||95% Confidence Interval|Mean
33194|NCT01550705|Secondary|Participants With Increased Sun Sensitivity|Study participants were asked to report after 3 months if they had experienced an increase in subjective measures of sun sensitivity during the trial. Reported outcome is the number of study participants who reported increased sun sensitivity|Baseline and 3 Months|||participants|||Number
33195|NCT01550705|Primary|Change in Plasma Protoporphyrin IX Level|Plasma Protoporphyrin IX will be measured at baseline and at 3 months|Baseline and 3 Months|||µg/dL||Standard Deviation|Mean
33196|NCT01550549|Post-Hoc|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|Baseline scan|||florbetapir scans|||Number
33197|NCT01550549|Post-Hoc|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|Baseline scan|||florbetapir scans|||Number
33198|NCT01550549|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|Baseline scan|||percentage of true positives/negatives||Full Range|Median
33199|NCT01550549|Post-Hoc|Inter-reader Reliability|Measure of agreement among multiple readers using binary read method (Fleiss' kappa). Where available, histopathology analysis at autopsy was the truth standard (TS).|Scan acquired 50-60 min post-injection|59 from study A07(NCT00857415)/A16(NCT01447719) and 92 from study A05(NCT00702143)||kappa statistic||95% Confidence Interval|Number
33200|NCT01550549|Secondary|Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true negatives which are correctly identified|at autopsy, within 2 years of scan|||percentage of negative cases IDed||95% Confidence Interval|Number
33201|NCT01550549|Secondary|Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true positives which are correctly identified|at autopsy, within 2 years of scan|||percentage of positive cases IDed||95% Confidence Interval|Number
33202|NCT01550549|Primary|Inter-rater Reliability|Measure of agreement among five readers using a binary read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.|Scan acquired 50-60 min post-injection|59 autopsy subjects (study A07[NCT00857415]/A16[NCT01447719]) + 20 healthy controls + 20 mild cognitive impairment + 20 AD (from study A05[NCT00702143])||kappa statistic||95% Confidence Interval|Number
33203|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.||Titer ratio||95% Confidence Interval|Geometric Mean
33204|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
33205|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.||Titer ratio||95% Confidence Interval|Geometric Mean
33206|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
33207|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
33208|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
33209|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
33210|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
33211|NCT01550289|Primary|Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.|Day 0 up to Day 14 post each injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.||Percentage of participants|||Number
33212|NCT01550289|Primary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.||Titer ratio||95% Confidence Interval|Geometric Mean
33213|NCT01550289|Primary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
33214|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
33215|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.||Percentage of participants|||Number
33216|NCT01549977|Secondary|Percentage of Participants Stopping ETT Due to Angina at Week 12|The percentage of participants who had to stop exercise treatment testing (ETT) due to experiencing angina symptoms at Week 12.|Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
33217|NCT01549977|Secondary|Change From Baseline in Maximum ST-segment Depression During ETT at Week 12|The change between the maximum ST-segment depression during ETT at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
33220|NCT01549977|Primary|Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12|The change between the duration of ETT at Week 12 relative to Baseline. ETTs were conducted using the modified Bruce Protocol. Participants exercised on a treadmill, starting at 1.7 mph and 0% incline. The intensity of exercise (speed and/or incline) was increased at 3 minute intervals.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.|||||
33221|NCT01549964|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 relative to Baseline. A MMRM model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.||mg/dL||Standard Error|Least Squares Mean
33222|NCT01549964|Secondary|Incidence of HbA1c <7%|Incidence (percentage) of participants with glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than 7% at Week 24.|24 Weeks|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized||percentage of participants|||Number
33223|NCT01549964|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A Mixed Model Repeated Measures (MMRM) model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.||Percent||Standard Error|Least Squares Mean
33224|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in ECG|The number of participants who reported clinically significant abnormalities in ECG were measured throughout study. ECGs were performed after the participant had been supine for at least 10 minutes.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
33225|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
33226|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs|The number of participants with any clinically significant abnormalities in vital signs collected throughout study. Vital signs included body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
33227|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values|The number of participants with any clinically significant abnormalities in safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
33228|NCT01549951|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.||participants|||Number
33229|NCT01549951|Secondary|Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
33230|NCT01549951|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.||hours||Full Range|Median
33432|NCT01545232|Secondary|Initial Hospital Discharge Status||Hospital discharge or 30 days, whichever comes first|Disposition of subject at time of hospital discharge||participants|||Number
33231|NCT01549951|Secondary|AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite|AUC(0-6) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 6 hours in this study). Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|Pharmacokinetic (PK) population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
33232|NCT01549951|Secondary|Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel|Coefficient of correlation was measured using linear mixed effects model for the association between two variables; change from baseline versus the plasma concentration. Participant’s effects on the intercept and plasma concentration slope were included in the model as random effects terms. Plasma concentrations were re scaled for model convergence. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||correlation coefficient||Standard Error|Least Squares Mean
33233|NCT01549951|Secondary|Number of Participants Reporting Change From Baseline in ECG Morphology|Participants with incidence of ECG morphology abnormalities were observed. Types of abnormalities included appearance of abnormal U waves, T waves inversion, elevation of ST segment, depression of ST segment, second or third degree heart block, right or left bundle branch block, atrial fibrillation/flutter, and myocardial infarction. New morphological changes were observed in abnormal U waves, depression of ST segment, and T waves inversion. Here, 'new' refers to change not present at baseline, ie, at any evaluation predose, and only seen postbaseline. Results of change in ECG morphology analyzed from 12-lead ECGs at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||participant|||Number
33234|NCT01549951|Secondary|Changes From Baseline in Heart Rate|Triplicate 12-lead Electrocardiogram (ECG) measurements were performed and average was calculated. Supine heart rate was measured as beats per minute (bpm). Results of change in heart rate analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||bpm||Standard Deviation|Mean
33235|NCT01549951|Secondary|Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 1 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette’s formula (QTcB = QT divided by square root of RR). Results of change in QTcB, PR, QRS and uncorrected QT analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||msec||Standard Deviation|Mean
33236|NCT01549951|Primary|Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.||millisecond (msec)||Standard Deviation|Mean
33237|NCT01549925|Primary|Surgical Time|To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures|at time of surgery, up to 10 minutes|||SECONDS||95% Confidence Interval|Mean
33238|NCT01549873|Secondary|Latency of the SSEP’s|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. Latency is the time interval between the stimulation and response.|day of surgery|||milliseconds||Standard Deviation|Mean
33757|NCT01541553|Secondary|Percentage Change From Baseline in Number of AKs at Week 11|Percentage change from baseline in number of AKs at Week 11|Baseline to week 11|||percentage of change||Standard Deviation|Mean
33240|NCT01549873|Primary|Amplitude Required to Elicit the MEP|Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).|at time of surgery|||milliamperes||Standard Deviation|Mean
33241|NCT01549860|Secondary|Change in Pain VAS Scores|"Compare VAS Pain Scores between arms at baseline and 4 weeks post randomization~Subjects indicate their pain level by drawing a mark on a 10 cm line on a visual analog scale (VAS) at randomization and 4 week post treatment visit. The left end of the line indicates no pain and the right end of line indicates worst pain imaginable. VAS score is determined by using a ruler placed at 0 (left end of scale) and measuring the distance from zero to the patient's mark . The objective is to compare the change in VAS values in MIST+SC to SC alone.~H0: The average change in pain level is not different between MIST and SC HA: The average change in pain level is different between MIST and SC H0: µMIST = µSC vs HA: µMIST ≠ µSC,~Statistical Analysis. A repeated measures ANCOVA will be used to test for differences in change in VAS with an indicator variable to indicate treatment, any demographic variables which were significant in the baseline comparisons."|Baseline, 2 weeks and 4 weeks post randomization|Eligible Subjects Randomized||VAS pain level measured in centimeters||Full Range|Median
33242|NCT01549860|Secondary|Heal Rates|Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.|12 weeks post randomization|Eligible subjects randomized||participants|||Number
33243|NCT01549860|Primary|Wound Area Mean Percent Reduction|"Compare between the treatment groups percent wound area reduction at four weeks of study treatment.~H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size."|4 weeks post baseline visit (randomization visit)|eligible subjects that were randomized||percentage of mean area reduction||Standard Deviation|Mean
33244|NCT01549613|Secondary|Digital and Infrared Imaging|Change in lesion area and temperature|Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.||||||
33245|NCT01549613|Primary|Satisfaction of Discharge Criteria|RDTC cellulitis protocol discharge criteria|Time point at which outcome measure is assessed 30 days from the date of admission.|||participants|||Number
33246|NCT01549405|Primary|Total Consumption of Tramadol Will be Measured for the First 24 Hours||Postoperative 24th hour|||mg||Standard Deviation|Mean
33247|NCT01549405|Secondary|Postoperative Pain Will be Evaluated.|The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.(“0” no pain, to “10”, the maximum pain )Pain score less then 4 is acceptable.|24 hours|||units on a scale||Inter-Quartile Range|Median
33248|NCT01549405|Primary|Postoperative Analgesic (Tramadol) Consumption|Total consumption of tramadol will be measured for the first 24 hours.|Postoperative 24th hour||||||
33249|NCT01549392|Primary|3 Month Response|participants who had reduction of tumor size from avastin at 3 months|at 3 months after initial DECT and MR spectroscopy|||participants who had tumor reduction|||Number
33250|NCT01549340|Secondary|Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone|The mean duration in years of SCIT or SLIT treatment for all participants with AR and asthma and for all participants with AR only was calculated. Duration of SCIT or SLIT treatment was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR and asthma or AR alone who were advised by their physician to receive AIT to treat their AR and who initiated AIT.||years||Standard Deviation|Mean
33251|NCT01549340|Secondary|Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT|The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.|Up to 5 years|The analysis population consisted of those participants with AR and asthma who were advised by their physician to receive AIT to treat their AR and who initiated SCIT or SLIT.||percentage of participants|||Number
33252|NCT01549340|Primary|Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course|The reason for discontinuation of SCIT or SLIT treatment more than 6 months before completion of the recommended course of therapy was recorded. The percentage of participants whose records were reveiwed and who discontinued SCIT or SLIT due to different reasons was calculated.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR, who initiated and subsequently discontinued AIT, and had their charts reviewed for the reason for discontinuation.||percentage of participants|||Number
33253|NCT01549340|Primary|Duration of Treatment With SCIT or SLIT|The mean duration in years of SCIT or SLIT treatment for all participants with AR who initiated SCIT or SLIT was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.||years||Standard Deviation|Mean
33254|NCT01549340|Primary|Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment|The percentage of participants who initiated SCIT or SLIT and completed 5 years of treatment was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled. If extract refills continued past the recommended time for therapy (e.g. 5 years from the start of therapy), the participant was deemed successful in completing the recommended course. If the extract refills stopped prior to the end of the recommended time for therapy, but the last refill occurred within 6 months of the recommended time for therapy, this participant was deemed successful in completing the recommended course.|At 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.||percentage of participants|||Number
33255|NCT01549340|Primary|Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops|The percentage of participants who were advised by their physician to start AIT and elected to initiate AIT was calculated. AIT initiation was broken down by type of AIT initiated (SCIT or SLIT).|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR.||percentage of participants|||Number
33433|NCT01545232|Secondary|Incidence of Transfusion Related Serious Adverse Events||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of transfusion related serious adverse events-Reportable to FDA||participants|||Number
33256|NCT01549275|Secondary|Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells|104 Patients with complete follow-up data were further divided into receiving (1) curative treatment of HCC including operative resection and local ablation therapy, (2) palliative transcatheter arterial chemoembolization (TACE), and (3) supportive treatment.|6 months after plating of cells|Correlation between the growth speeds of cultured cells and worsening of AJCC TNM stages or HCC related death 6 months after plating of cells||participants|||Number
33257|NCT01549275|Primary|Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study.|Patients were divided into AJCC TNM staging < = IIIA and > = IIIB two groups. The incidences of patients with rapidly proliferative cultured cells in these two groups were compared. Rapidly proliferative group was defined as (1) growth area of cultured cells at the 28th day of primary culture exceeded two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 28th day reached > 70% growth area of the flask. Based on the results from special stain, patients in rapidly proliferative group were further divided into patients with rapid proliferation of HCC cells alone, rapid proliferation of HCC cells with concomitant cancer-associated fibroblasts (CAFs) (HCC + CAFs) and CAFs alone.|28 days after plating of cells|Comparison the incidence of patients with rapidly proliferative cultured cells between two groups||participants|||Number
33258|NCT01549041|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7 with 1 representing the lowest severity of symptoms and 7 representing the highest severity; thus the lowest and highest possible total scores are 18 and 126|From baseline to day 14|||units on a scale||Standard Error|Mean
33259|NCT01549041|Primary|Patient Acceptance|A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment.|At day 14|||units on a scale||Standard Error|Mean
33260|NCT01549002|Secondary|Score on Likert Scale for Patient Satisfaction|Patient satisfaction will be measured on a Likert scale just prior to Emergency Department discharge. If the patient is 8 years of age and older, both the patient and the parent or guardian will complete a satisfaction survey. If the patients is younger than 8 years, their parent or guardian will complete the satisfaction survey.|10 minutes after procedure completion||||||
33261|NCT01549002|Secondary|Score on the Faces Pain Scale Revised (FPS-R)|The Faces Pain Scale Revised (FPS-R) has been validated in patients 4 - 16 years of age undergoing painful procedures and will be used to assess patients' self reported pain. Patients will complete the FPS-R at four times during their medical encounter: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion.|Up to 10 minutes after procedure completion||||||
33262|NCT01549002|Primary|Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)|Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The scores documented here are the total OSBD-R scores.|Up to 10 minutes after the procedure completion|||units on a scale||Standard Deviation|Mean
33263|NCT01548885|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose(BG) below 70 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number (190) of BG results was possible for each BGMS. Subjects provided 1,2,or 3 capillary samples, of which 190 samples were less than 70 mg/dL.||percentage|Participants|95% Confidence Interval|Mean
33264|NCT01548885|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number 388(393-3-2)BG results possible for each BGMS.Subjects provided 1,2,or 3 capillary samples-total 393 samples. 3 glycolyzed samples were not analyzed - glycolysis exceeded the protocol-defined time. All meter data for 2 glycolyzed samples were not evaluable (not analyzed)- their YSI results were less than the meter operating ranges.||percentage|Participants|95% Confidence Interval|Mean
33265|NCT01548833|Primary|Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.|Day 7, 16 hours after lens insertion|||seconds||Standard Deviation|Mean
33266|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)|% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.|Weeks 9 and 17|Intent to treat analysis||percentage clinical responders||95% Confidence Interval|Number
33267|NCT01548742|Secondary|Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up|The PHQ-9 is a valid and reliable measure of depression symptom severity. Score range from 0-27; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 5 or more points on the PHQ-9.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).||units on a scale||95% Confidence Interval|Mean
33268|NCT01548742|Secondary|PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up|The CAPS is a valid and reliable measure of PTSD symptom severity. Score range from 0-136; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the CAPS.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).||units on a scale||95% Confidence Interval|Mean
33269|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL|% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.|Weeks 9 and 17|Intent to treat analysis||percentage clinical responders||95% Confidence Interval|Number
33270|NCT01548742|Primary|PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up|The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.|Baseline, Weeks 3, 6, 9 and 17|Intent to treat population (all participants randomized to treatment).||units on a scale||95% Confidence Interval|Mean
33271|NCT01548638|Secondary|Side Effects of Galantamine|"Side effects of galantamine were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). A 37-item checklist of side effects based on the product insert (e.g., Nausea, Vomiting, Diarrhea, Loss of appetite, Stomach pain, Constipation, Gastroesophageal Reflux Problems (Heartburn)) was administered to participants at all study visits after the Intake. An open-ended side effects question was also be included.~Items were measured on a scale from 0 (None) to 3 (Severe).~The side effect summary score (total side effects averaged from the 37 item checklist) at each visit is reported below. Each score ranges from 0 (None) to 3 (Severe)."|Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session|||units on a scale||Standard Deviation|Mean
33272|NCT01548638|Secondary|Subjective Symptoms - Smoking Behavior, Urges, Mood, Nicotine Withdrawal|The subjective symptoms listed above will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).|Days 7, 14, 21, 28, 35, and 43; Baseline session||||||
33273|NCT01548638|Secondary|Cognitive Performance: Working Memory Accuracy|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.~Number of correct responses (true positives) is described below.~The maximum number of correct responses is 60."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43|||correct responses||Standard Deviation|Mean
33274|NCT01548638|Secondary|Cognitive Performance: Working Memory Reaction Time|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.~Median reaction time to correct responses is described below.~Typical responses range from 250 ms to 1500 ms."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43|||ms||Standard Deviation|Mean
33275|NCT01548638|Primary|Number of Days of Abstinence During a 7-day Quit Attempt|Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.|Days 36-43; following a 5-week dose run-up|||days||Full Range|Mean
33276|NCT01548417|Secondary|Drinking|Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70.|2 weeks|Three randomized subjects who met exclusionary criteria were not included in the regression analysis for drinking: two subjects were excluded for unreliable reporting and one subject was excluded for being treatment seeking.||alcoholic drinks per week||Standard Error|Mean
33277|NCT01548417|Primary|Craving to Drink|Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.|1 week|1 participant who completed the study had missing VAS scores.||units on a scale||Standard Error|Mean
33278|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Population with valid actigraphy data||% (efficiency=% of time asleep)||90% Confidence Interval|Least Squares Mean
33279|NCT01548287|Secondary|Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data||Minutes||90% Confidence Interval|Least Squares Mean
33434|NCT01545232|Secondary|Incidence of Primary Surgical Procedure||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of primary surgical procedure||participants|||Number
33280|NCT01548287|Secondary|Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data||Minutes||90% Confidence Interval|Least Squares Mean
33281|NCT01548287|Secondary|Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set||Rank transformed duration (minutes)||90% Confidence Interval|Least Squares Mean
33282|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set||% change||90% Confidence Interval|Least Squares Mean
33283|NCT01548287|Primary|Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.|Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.|Baseline and Week 4.|Primary analysis set||Minutes||90% Confidence Interval|Least Squares Mean
33284|NCT01547728|Primary|Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration|Restored antithrombin level is defined as an activated clotting time > 480 seconds 3 minutes after the initial dose of 500 units of rhAT is administered. The percentage of patients who meet this criterion will be summarized using a point estimate and a 95% confidence interval.|3 minutes after the initial dose of rhAT, Day 1 of the study|The study was terminated because there were too many barriers to enroll participants.|||||
33285|NCT01547715|Secondary|Number of Subjects With Unsolicited Adverse Events|The safety of one dose of MenACWY –CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.|Day 1 through day 29|The analysis was performed on the safety analysis dataset.||participants|||Number
33286|NCT01547715|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set.||Participants|||Number
33287|NCT01547715|Secondary|Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.||Participants|||Number
33288|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33289|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33290|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33291|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33292|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33293|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33294|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.|Day 29 ( ie, 1 month post vaccination)|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33295|NCT01547715|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS.||Titer||95% Confidence Interval|Geometric Mean
33296|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33297|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33298|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.|Day 29|Analysis was done on the FAS.||Percentage||95% Confidence Interval|Number
33299|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33300|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33301|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33302|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33303|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS||Percentage of subjects||95% Confidence Interval|Number
33304|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33305|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33306|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.||Percentages of subjects||95% Confidence Interval|Number
33307|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A.|Day 29 (1 month post vaccination)|Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.||Percentages of subjects||95% Confidence Interval|Number
33308|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 6|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 6|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
33309|NCT01547598|Secondary|Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg|IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.||percentage of participants|||Number
33310|NCT01547598|Secondary|Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline|IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Baseline, Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.||percentage of participants|||Number
33311|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
33312|NCT01547598|Primary|Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the modified Intent-to-treat (mITT) population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.||mmHg||Standard Deviation|Mean
33313|NCT01547299|Secondary|Number of Patients With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation|To assess the number of patients with AEs that led to permanent discontinuation of enzalutamide, temporary interruption of enzalutamide, dose reduction of enzalutamide, or study drug (enzalutamide, leuprolide, or dutasteride) discontinuation.|6 months|All patients who received at least one partial dose of enzalutamide.||patients|||Number
33314|NCT01547299|Secondary|Change From Baseline in Serum Testosterone|To determine serum hormone effects as measured by change in testosterone at baseline and at completion of therapy.|Baseline, 6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a serum testosterone result at baseline and 6 months postbaseline.||ng/mL||Full Range|Median
33315|NCT01547299|Secondary|Serum Testosterone: 6 Months Postbaseline||6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a 6 month postbaseline serum testosterone result.||ng/mL||Full Range|Median
33316|NCT01547299|Secondary|Serum Testosterone: Baseline||Baseline|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline serum testosterone result.||ng/mL||Full Range|Median
33317|NCT01547299|Secondary|Change From Baseline in Serum Dihydrotestosterone (DHT)|To determine serum hormone effects as measured by change in DHT values from baseline to the completion of therapy.|Baseline, 6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a serum DHT result at baseline and 6 months postbaseline.||ng/mL||Full Range|Median
33318|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): 6 Months Postbaseline||6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a 6 month postbaseline serum DHT result.||ng/mL||Full Range|Median
33319|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): Baseline||Baseline|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline serum DHT result.||ng/mL||Full Range|Median
33320|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling|To determine the effects of triplet therapy and enzalutamide alone on androgen receptor signaling in prostatectomy specimens.|6 months||08/2015||||
33321|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Mitotic Index|To determine the effects of triplet therapy and enzalutamide alone on mitotic index (rate of cell growth) in prostatectomy specimens.|6 months||08/2015||||
33322|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Apoptosis|"To determine the effects of triplet therapy and enzalutamide alone on apoptosis in prostatectomy specimens.~Assessment of apoptosis was not performed due to limited amounts of tissue available."|6 months||||||
33323|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Testosterone|To determine pharmacodynamic effects as measured by tissue testosterone in prostatectomy specimens following radical prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist.||pg/mg||Full Range|Median
33324|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)|To determine pharmacodynamic effects as measured by tissue DHT in prostatectomy specimens following radical prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist.||pg/mg||Full Range|Median
33325|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Mental Component Summary|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in mental component summary is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33326|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Role-Emotional Domain Score|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in role-emotional domain score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33327|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Physical Functioning Domain Score|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in physical functioning domain score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33328|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 General Health Domain Score|The Twelve-Item Short Form Version 2 is an HRQoL instrument that measures general health and well-being across physical and mental components. Best change from baseline category in general health domain score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33471|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||mEq/min||Standard Deviation|Mean
33329|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score|EPIC Hormonal Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's hormonal function. Best change from baseline category in EPIC hormonal bother subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33330|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score|EPIC Hormonal Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's hormonal function. Best change from baseline category in EPIC hormonal function subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33331|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score|EPIC Hormonal Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's hormonal function. Best change from baseline category in EPIC hormonal domain summary score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33332|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score|EPIC Sexual Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's sexual function and sexual satisfaction. Best change from baseline category in EPIC sexual bother subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33333|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score|EPIC Sexual Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's sexual function and sexual satisfaction. Best change from baseline category in EPIC sexual function subscale score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33334|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score|EPIC Sexual Domain is an HRQoL instrument that measures the effects of prostate cancer treatment on a patient's sexual function and sexual satisfaction. Best change from baseline category in EPIC sexual domain summary score is summarized below. Categories are worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference is defined as one-half the standard deviation of the score of interest at baseline.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one postbaseline score.||patients|||Number
33335|NCT01547299|Secondary|Percentage of Patients With Reduction in Prostate-Specific Antigen (PSA)|To determine the effects on PSA as measured by the percentage of patients with PSA < 0.2 ng/mL, and a 50% and 90% decrease in PSA value prior to prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one postbaseline PSA.||percentage of patients||95% Confidence Interval|Number
33336|NCT01547299|Secondary|Time to Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the time to the lowest postbaseline PSA value prior to prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one postbaseline PSA.||months||Full Range|Median
33337|NCT01547299|Secondary|Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the lowest postbaseline PSA value prior to prostatectomy.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one postbaseline PSA.||µg/L||Full Range|Median
33338|NCT01547299|Secondary|Percentage of Patients With Positive Lymph Nodes|To determine the percentage of patients with positive lymph nodes at prostatectomy as assessed by the local and central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
33339|NCT01547299|Secondary|Percentage of Patients With Positive Seminal Vesicles|To determine the percentage of patients with positive seminal vesicles at prostatectomy as assessed by the local and central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
33472|NCT01544998|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes||Baseline, 60 minutes after saline load||05/2017||||
33473|NCT01544998|Secondary|Change in Glomerular Filtration Rate (GFR) at 60 Minutes||Baseline, 60 minutes after saline load||05/2017||||
33340|NCT01547299|Secondary|Percentage of Patients With Extracapsular Extension: Central Review|To determine the percentage of patients with extracapsular extension at prostatectomy as assessed by the central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. One patient in the Enzalutamide alone treatment arm was excluded from the analysis because the result reported by the central lab was indeterminate.||percentage of patients||95% Confidence Interval|Number
33341|NCT01547299|Secondary|Percentage of Patients With Extracapsular Extension: Local Review|To determine the percentage of patients with extracapsular extension at prostatectomy as assessed by the local pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist.||percentage of patients||95% Confidence Interval|Number
33342|NCT01547299|Secondary|Percentage of Patients With Positive Surgical Margins|To determine the percentage of patients with positive surgical margins at prostatectomy as assessed by the local and central pathologist.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
33343|NCT01547299|Primary|Pathologic Complete Response Rate|Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 6 months prior to prostatectomy in patients with localized prostate cancer. Pathologic complete response is defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as evaluated by the site pathologist using standard methods.|6 months|All patients randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist.||percentage of patients||95% Confidence Interval|Number
33344|NCT01547247|Secondary|Success Rate of Minimal Sedation Colonoscopy|A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.|3 months|||percentage of all subjects in arm|||Number
33345|NCT01547247|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months||||||
33346|NCT01547247|Primary|Cecal Intubation Time|The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.|3 months|Statistical power was calculated for the primary endpoint. A sample size of 93 subjects per arm was calculated using two-tailed alfa 0.05, beta 0.2, assuming that difference 20 % in intubation times would have been clinically relevant.||minutes||95% Confidence Interval|Number
33347|NCT01547130|Secondary|Total Preparation Time|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.|Upto 24 weeks|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.||hours||Full Range|Mean
33348|NCT01547130|Secondary|Patient-reported Adverse Events.|Patients from both groups reported adverse events in a symptom questionnaire.|Upto 24 weeks|Patients from both groups reported adverse events in a symptom questionnaire.||participants|||Number
33349|NCT01547130|Secondary|Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.|"Subjects rated the SCC as Willingness to repeat the same prep in future"|Upto 24 weeks|Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale.||participants|||Number
33350|NCT01547130|Secondary|Palatability of Bowel Prep|"Patients completed a symptom questionnaire where they rated solution palatability of their assigned prep on a 1-5 Likert scale. A rating of more than 3 was considered as Palatable."|Upto 24 weeks|All subjects enrolled and completed the bowel preparation. .||participants|||Number
33351|NCT01547130|Primary|Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy|The primary endpoint was the “success” rate of the preparations. Preparation efficacy was evaluated by a single, blinded endoscopist (V.A.), who performed all of the colonoscopies. The evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon and cecum) on the 5 point Arya Bowel Prep Scale (ABPS). Aggregating the segmental scores resulted in overall scores. Grade A was defined as a total overall score of 19–24, grade B as a score of 13–18, grade C as a score of 7–12, and grade D as a score of 0–6. Grade A or B preparation was considered “successes”, while grade C or D was considered “failures.” To assess the reliability of ABPS, we trained 4 gastroenterologists and 3 fellows.|Within 48 hours of bowel preparation|The non-inferiority margin was set at -15%. This means the intervention will be considered non-inferior if the difference in success rates is less than 15%. The study was designed to have 90% power to establish non-inferiority when the two treatment groups are equivalent using a one-tailed test at the 5% significance level.||Score||Standard Deviation|Mean
33352|NCT01546922|Secondary|Change in Perceived Common Somatic Complaints After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|The patients report common somatic complaints by filling in structured daily diaries.|during treatment period 1 (that is from week 1 to week 10 from baseline) and during treatment period 2 (that is from week 11 to week 20 from baseline).||||||
33353|NCT01546922|Secondary|Change in Somatosensation After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Measures of somatosensation: the mechanical detection threshold, the mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, wind up ratio and the pressure pain threshold.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).||||||
33354|NCT01546922|Secondary|Change in Metabolic Profile After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Cardiovascular and metabolic risk factors, (pituitary) hormones and bone markers.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).||||||
33355|NCT01546922|Secondary|Change in Quality of Life After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Quality of life questionnaires have to be filled in by the participant at his/her home place and have to be returned by post.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).||||||
33356|NCT01546922|Primary|Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|"Cognitive domains to be tested: memory, executive functioning, attention and social cognition.~The psychological tests consist of oral and written questions or computer tasks.~Data is given as Z-scores based on normative data. Higher Z-scores represent a better performance."|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|The participants completing both study periods were analyzed||Z-scores based on normative data.||Standard Deviation|Mean
33357|NCT01546883|Primary|Percentage of Fibrosis|We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.|MRI at baseline and MRI at 12 months post-enrollment|Data were not collected for the analysis population and therefore could not be summarized to include in this report.|||||
33358|NCT01546688|Secondary|Percentage of Responders During Last 28 Days of Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits.|Baseline and Month 4|Intent-to-Treat Population. Percentages are based on the number of subjects present in the Maintenance Phase.||Percentage of Participants|||Number
33359|NCT01546688|Secondary|Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.|Baseline and Month 4|Intent-to-Treat Population.||Percent Change||Full Range|Median
33360|NCT01546688|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period|The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population||Scores on a Scale||Standard Deviation|Mean
33361|NCT01546688|Primary|Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period|The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication.||Seconds||Standard Deviation|Mean
33362|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale|The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|After 4 weeks of home use (2 weeks for each socket style)|||units on a scale|||Number
33363|NCT01546675|Primary|Degrees of Shoulder Displacement Within the Prosthetic Socket|A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|||degrees|||Number
33364|NCT01546675|Primary|Degrees of Shoulder Internal Rotation Within the Prosthetic Socket|Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|||degrees|||Number
33365|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale|The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|after 2 weeks of home use of each socket type|||units on a scale|||Number
33366|NCT01546675|Secondary|Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)|This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.|After 4 weeks of home use (2 weeks for each socket style)|||units on a scale|||Number
33367|NCT01546675|Primary|Degrees of Shoulder Abduction Within the Prosthetic Socket|Shoulder abduction was performed to the subject’s maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|One male and one female with traumatic amputation at the transhumeral level.||degrees|||Number
33368|NCT01546649|Secondary|QT Interval Measured by 12-lead Electrocardiogram (ECG)|12-lead electrocardiography measurement was performed in supine position after 5 minutes at rest. Each measurement was recorded continuously for 10 seconds at the recording speed of 25 millimeter/second (mm/second).|Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337|Safety evaluation was conducted in the safety analysis set (SAS). Here ‘N’ represents evaluable baseline and post-baseline assessment population.||millisecond (msec)||Standard Deviation|Mean
34071|NCT01536145|Secondary|Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||0 hour (predose) in Cycles 2 up to 16|Multiple dose Cmin data were listed for individual subjects, however were not summarized by descriptive statistics.|||||
33369|NCT01546649|Secondary|Serum Unchanged TAP-144 Level|This measure indicates the unchanged TAP-144 level in serum.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309 and 337|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||nanogram per deciliter (ng/dL)||Standard Deviation|Mean
33370|NCT01546649|Secondary|Distant Disease Free Survival (DDFS) Rate at Week 96|DDFS is defined as time from randomization to earliest day of onset the events, distant recurrence, secondary cancer [including breast cancer in the contralateral breast] and death. DDFS at week 96 was defined as the percentage calculated with Kaplan-Meier method, of participants did not experience any events at week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.||percentage of participants|||Number
33371|NCT01546649|Secondary|Disease Free Survival (DFS) Rate at Week 96|DFS is defined as time from randomization to earliest day of onset the events, recurrence [including recurrence in the ipsilateral breast], secondary cancer [including breast cancer in the contralateral breast] and death. DFS at Week 96 was defined as the percentage, calculated with Kaplan-Meier method, of participants did not experience any events at Week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.||percentage of participants|||Number
33372|NCT01546649|Secondary|Concentration of Follicle Stimulating Hormone (FSH)|This measure indicates serum FSH concentration at baseline and post-baseline time points.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||mIU/mL||Full Range|Median
33373|NCT01546649|Secondary|Concentration of Serum Luteinizing Hormone (LH)|This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||mIU/mL||Full Range|Median
33374|NCT01546649|Secondary|Concentration of Serum E2|The measure indicates serum E2 concentration at baseline and post-baseline time points.|Baseline, Hour (hr) 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.||pg/mL||Full Range|Median
33375|NCT01546649|Primary|Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48|Comparison of both the treatment groups was done by assessing the suppressive effect on serum E2 concentration maintained at menopausal level (=<30pg/mL). Suppression rate was calculated as proportion of participants maintained at menopausal level.|Week 4 up to Week 48|Full analysis set (FAS) included all randomized participants who had received at least a single dose of study treatment.||percentage of participants||95% Confidence Interval|Number
33376|NCT01546636|Secondary|Postanesthesia Care Unit Length of Stay (Total Time)||Approximately 5 hours|||minutes||Full Range|Median
33377|NCT01546636|Secondary|Number of Patients Experiencing Nausea and Vomiting|Assessed by recovery nurses|Postanesthesia care unit-first 2 hours|||participants|||Number
33378|NCT01546636|Primary|Incidence of Cerebral Desaturation Events|Cerebral desaturation events were measured with near-infrared spectroscopy|Intraoperative-first 2 hours|||number of events|||Number
33379|NCT01546623|Secondary|12-lead ECG||At 1 hour, week 24, and week 48 after administration|Safety evaluation was conducted in the safety analysis set (SAS), which includes all 160 patients who received the study drug [TAP-144-SR (&M) group: 81 patients, TAP-144-SR (3M) group: 79 patients||msec||Standard Deviation|Mean
33380|NCT01546623|Secondary|Serum Unchanged TAP-144 Level||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||ng/dL||Standard Deviation|Mean
33381|NCT01546623|Secondary|Bone Lesion Response|Partially revised assessment based on the “criteria for therapeutic effect” from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression|At Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||Percentage of participants|||Number
33382|NCT01546623|Secondary|Soft Tissue Response|Assessment in accordance with the “criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||Percentage of participants|||Number
33383|NCT01546623|Secondary|Percentage of Participants With Progression by PSA (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants|Participants||Number
33474|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||mEq/min||Standard Deviation|Mean
33384|NCT01546623|Secondary|The Maximum Rate of Change in PSA Suppression (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percent change||Full Range|Median
33385|NCT01546623|Secondary|Time Course of Change Rate in Serum PSA (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen [PSA])|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percent change||Full Range|Median
33386|NCT01546623|Secondary|Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||mIU/mL||Full Range|Median
33387|NCT01546623|Secondary|Time Course of Changes in Serum Luteinizing Hormone (LH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||mIU/mL|Participants|Full Range|Median
33388|NCT01546623|Secondary|Time Course of Changes in Serum Testosterone||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||ng/dL||Full Range|Median
33389|NCT01546623|Primary|The Rate of Suppression of Serum Testosterone to Castrate Level|Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)|From the start of study drug administration through Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of study drug) was used.||Participants|||Number
33390|NCT01546519|Secondary|Apparent Non-renal Clearance (CLNR/F) of Vismodegib|Apparent Non-Renal Clearance (CLNR) describes the removal of vismodegib by organs other than the kidneys. This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
33391|NCT01546519|Secondary|Apparent Clearance (CL/F) of Vismodegib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr). This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
33392|NCT01546519|Secondary|Minimum Plasma Concentration (Cmin) of Vismodegib|Cmin is defined as the minimum observed plasma concentration of Vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
33393|NCT01546519|Secondary|Time to Maximum Plasma Concentration (Tmax) of Vismodegib|Tmax is the time to reach maximum plasma concentration of vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.|||||
33394|NCT01546519|Secondary|Amount of Vismodegib Excreted Into Urine in 24 Hours (Ae0-24hr)|The amount of total vismodegib excreted in urine over a 24-hr total interval (Ae0-24hr) was estimated.|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.||milligrams/24 hour||Standard Deviation|Mean
33395|NCT01546519|Secondary|Renal Clearance of Vismodegib|Renal clearance (CLR) is defined as the apparent total clearance of the drug from plasma after oral administration.|0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.||Liter/hour||Standard Deviation|Mean
33396|NCT01546519|Secondary|The Percentage of Dose of Vismodegib in 24-hour Total Urine|The percentage of dose vismodegib excreted in urine over a 24-hr total interval was estimated|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.||% Dose Excreted in 24 hr||Standard Deviation|Mean
33397|NCT01546519|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-24hours]) Following Multiple Doses of Vismodegib|The steady state pharmacokinetic profile following oral administration of multiple doses of vismodegib included determining the area under the curve over the dosing interval (AUC[0-24 hours]). The AUC[0-24 hrs]) was determined by standard non-compartmental analysis using WinNonlin. Blood samples were collected at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8 to estimate AUC(0-24 hrs).|Day 1, 2, 4 and 0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples||Micromolar*hour||Standard Deviation|Mean
33497|NCT01544348|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit|Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.|Days 1 (pre-dose), 15, 43, and 85|Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result.||participants|||Number
33398|NCT01546519|Primary|Maximum Observed Plasma Concentration and Concentration at Steady-state Following Multiple Doses of Vismodegib|Maximum observed plasma Concentration (Cmax) & Concentration at steady-state (Css) following multiple doses of vismodegib (150 mg QD) were analyzed. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated. Blood samples for assessing Cmax and Css for analysis were collected following multiple oral doses of vismodegib at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8. From the plasma concentration-time curve, the PK parameter Cmax and Css were determined by standard non-compartmental analysis using WinNonlin|Day 1,2,4 and 0, 0.5, 1, 2, 4, 8 and 24 hours post dose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples||micromolar||Standard Deviation|Mean
33399|NCT01546454|Primary|Total to HDL Cholesterol Ratio||Entire Study|||Total to HDL Cholesterol Ratio||95% Confidence Interval|Mean
33400|NCT01546402|Secondary|Change in the Visual Acuity|Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best|Difference in number of letters read (6 months minus baseline)|||Number of letters on ETDRS scale||Standard Deviation|Mean
33401|NCT01546402|Primary|Change in the Central Macular Thickness|The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.|Baseline and 6 MONTHS|||Microns||Standard Deviation|Mean
33402|NCT01546285|Primary|Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements|The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.|End of each blood pressure reading|66 subjects were enrolled. 64 subjects contributed data to the study. Subject 058 had a lateral difference of the reference diastolic blood pressure more than 10mmHg, and NIBP data was excluded from final analysis as specified in AAMI SP-10 standard. And Subject 046 had circulation issues and no data was collected.||mmHg||Standard Deviation|Mean
33403|NCT01546207|Secondary|Signal-Average ECG|Relationship between change in pre/post saECG and success of the step-wise ablation strategy|baseline and post-op day one after procedure||||||
33404|NCT01546207|Secondary|Procedural Safety|2) Procedural safety as defined by the number of complication within 1week associated with the procedure.|1 week post-op||||||
33405|NCT01546207|Secondary|ICD Interrogation|Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.|baseline and 6 months follow-up||||||
33406|NCT01546207|Primary|Catheter Ablation|The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia|at time of catheter ablation procedure (intraoperative)||||||
33407|NCT01546194|Primary|Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).|Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.|First postoperative day|||units on a scale||Full Range|Median
33408|NCT01546142|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||units on a scale||Standard Deviation|Mean
33409|NCT01546142|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.||percentage of participants|||Number
33410|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
33452|NCT01544062|Secondary|48 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.||participants|||Number
33411|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
33412|NCT01545843|Secondary|Change in Neuropsychological Functioning|Change in multiple domains of neuropsychological functioning (e.g., memory, attention, executive functioning)|Baseline, 2 weeks, 8 weeks||||||
33413|NCT01545843|Secondary|Change in EEG Sleep Measures|Measurement of EEG activity during sleep using polysomnography|Baseline, 2 weeks, 8 weeks||||||
33414|NCT01545843|Secondary|Pittsburgh Sleep Quality Index|Self-report measure of sleep quality|Posttreatment (8 weeks)||||||
33415|NCT01545843|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.|Post-treatment (8 weeks)|||units on a scale||Standard Deviation|Mean
33416|NCT01545843|Primary|Hamilton Rating Scale for Depression-17 Item Minus Sleep Items|Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.|Post-treatment (8 weeks)|||units on a scale||Standard Deviation|Mean
33417|NCT01545765|Primary|Duration of Anesthesia(Minutes)|Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).|From T0 (product removal) up to T8 hours after product removal|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.||Minutes||Full Range|Median
33418|NCT01545765|Secondary|Adverse Events|Incidence of adverse events was to be reported during the study period|During the study|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.||participants|||Number
33419|NCT01545700|Primary|Serum Blood Glucose Concentrations|Serum blood glucose concentrations|Patient were followed for the duration of hospitalization, for an average of 6 days|per protocol||mg/dl||Standard Deviation|Mean
33420|NCT01545700|Secondary|Pain Scores|VAS pain scoes at rest 0=no pain, 100=worst pain imaginable|Patients were followed for the duration of hospitalization, for an average of 6 days|||0-100 VAS scale scores on a scale||Standard Deviation|Mean
33421|NCT01545518|Primary|Immune Abnormalities|neuronal nuclear, cytoplasmic, and cell surface autoantibodies|Screening visit|No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.|||||
33422|NCT01545388|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.||Participants|||Number
33423|NCT01545388|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Up to 26 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.||Percentage of participants|||Number
33424|NCT01545388|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Based on a cLDA model with terms for treatment, other prior AHA therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
33425|NCT01545388|Primary|Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)|Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
33426|NCT01545336|Secondary|Six Minute Walk Distance||Baseline, 3 months|||% change from baseline||Inter-Quartile Range|Median
33427|NCT01545336|Primary|Tricuspid Annular Plane Systolic Excursion (TAPSE)||Baseline, 3 months|||% change from baseline||Inter-Quartile Range|Median
33428|NCT01545336|Primary|Plasma Estradiol (E2) Level||Baseline, 3 months|||% change from baseline||Inter-Quartile Range|Median
33429|NCT01545232|Secondary|Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission||24 hours after ED admission|Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized.||units of blood products||Inter-Quartile Range|Median
33430|NCT01545232|Secondary|ICU Free Days||first 30 days after ED admission|Number of ICU free days for each group.||days||Inter-Quartile Range|Median
33435|NCT01545232|Secondary|Functional Status at Time of Hospital Discharge|The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.|Hospital discharge or 30 days, whichever comes first|Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) > 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum).||units on the GOSE scale||Inter-Quartile Range|Median
33436|NCT01545232|Secondary|Amount of Randomized Blood Products Given to Hemostasis||24 hours from randomization|||units of blood products||Inter-Quartile Range|Median
33437|NCT01545232|Secondary|Time to Hemostasis|Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.|ED admission to hospital discharge or 30 days, whichever comes first|Time to anatomic hemostasis||minutes||Inter-Quartile Range|Median
33438|NCT01545232|Secondary|Hospital Free Days||first 30 days after ED admission|Number of hospital free days for each group.||days||Inter-Quartile Range|Median
33439|NCT01545232|Primary|Coagulation and Inflammatory Phenotypes at Emergency Department Admission and Over Time.||72 hours||||||
33440|NCT01545232|Primary|30-day Mortality||First 30 days after ED admission|Number of subjects enrolled into each group.||participants|||Number
33441|NCT01545232|Primary|24-hour Mortality||First 24 hours after ED admission|Number of subjects who were randomized to each group||participants|||Number
33442|NCT01545193|Secondary|PACU Length of Stay|The time required to meet discharge criteria and achieve actual discharge will be noted.|Early postoperative period, up to 24 hours|||minutes||Inter-Quartile Range|Median
33443|NCT01545193|Secondary|Respiratory Events Potentially Related to Residual Neuromuscular Blockade|Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation < 94% on pulse oximetry) in the PACU|Early postoperative period, up to 24 hours|||participants|||Number
33444|NCT01545193|Secondary|Signs and Symptoms of Residual Neuromuscular Blockade|A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission|Early postoperative period, up to 24 hours|||symptoms||Inter-Quartile Range|Median
33445|NCT01545193|Primary|Incidence of Residual Neuromuscular Blockade|The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.9 in each group will be compared.|Early postoperative period, up to 24 hours|||participants|||Number
33446|NCT01544153|Secondary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence"|3 months post-randomization|Intent to treat||Participants|||Count of Participants
33447|NCT01544153|Primary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence."|9 months post-randomization|Intent to treat||Participants|||Count of Participants
33448|NCT01544062|Secondary|48 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 7 study subjects in normal saline group and 4 study subjects in IV acetaminophen group.||participants|||Number
33449|NCT01544062|Secondary|24 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
33450|NCT01544062|Secondary|48 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.||participants|||Number
33451|NCT01544062|Secondary|24 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
33470|NCT01544023|Primary|Participants Who Received TiLOOP Mesh Reconstruction|Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM.|1 month|||Patients with TiLOOP mesh reconstruction|||Number
33453|NCT01544062|Secondary|24 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
33454|NCT01544062|Secondary|48 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 8 study subjects in normal saline group and 6 study subjects in IV acetaminophen group.||participants|||Number
33455|NCT01544062|Secondary|24 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||participants|||Number
33456|NCT01544062|Secondary|48 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|||participants|||Number
33457|NCT01544062|Secondary|24 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|||participants|||Number
33458|NCT01544062|Secondary|48 Hour Patient Satisfaction|"The extent to which subjects overall pain experience met their expectations question responses were converted to the Likert scale with the following values: not at all (1), a little (2), a fair amount (3), very much (4) and extremely well (5)."|48 hours after arriving in ICU|Questionnaire not completed by 12 study subjects in normal saline group and 10 study subjects in IV acetaminophen group.||units on a scale||Standard Deviation|Mean
33459|NCT01544062|Secondary|Length of ICU Stay|The length of ICU stay will be determined based on the “ICU Discharge Criteria” checklist that will be completed by nursing staff every 4 hours until ICU discharge.|From the time of arrival in ICU until ICU discharge|||hours||Standard Deviation|Mean
33460|NCT01544062|Secondary|Length of Mechanical Ventilation|The length of mechanical ventilation will be determined based on the “Extubation Criteria” checklist that will be completed by nursing staff every 2 hours until extubation.|From the time of arrival in ICU until extubation|||minutes||Standard Deviation|Mean
33461|NCT01544062|Secondary|48 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.||cm||Standard Deviation|Mean
33462|NCT01544062|Secondary|24 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||cm||Standard Deviation|Mean
33463|NCT01544062|Secondary|48 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
33464|NCT01544062|Secondary|24 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
33465|NCT01544062|Secondary|48 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
33466|NCT01544062|Secondary|24 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data for 3 study subjects in normal saline group.||units on a scale||Standard Deviation|Mean
33467|NCT01544062|Secondary|48 Hour Postoperative Opioid Consumption|48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|48 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.||mg||Standard Deviation|Mean
33468|NCT01544062|Primary|24 Hour Postoperative Opioid Consumption|The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|24 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.||mg||Standard Deviation|Mean
33469|NCT01544023|Secondary|Complication Rate|Secondary study outcome was the prevalence of complications.|2 years|||percentage of participants|||Number
33475|NCT01544920|Secondary|Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24|SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in, who were randomized at Week 4, and also had undetectable HCV RNA at Week 4.||Percentage of participants|||Number
33476|NCT01544920|Primary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)|SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 74|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in and who were randomized at Week 4.||Percentage of participants|||Number
33477|NCT01544582|Secondary|Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash|The incidence (events per 1000 participant-days) of the protocol-defined HOIs (anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash) was calculated over the 48-week period following the start of CHC treatment exposure. All protocol-defined HOIs were taken into account (serious and non-serious HOIs). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The incidence per 1000 participant-days of anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash were reported by CHC treatment group of exposure with 95% confidence intervals.|Up to 48 weeks of treatment|Participants in Analysis Population (CHC genotype-1 participants meeting eligibility criteria and treated with boceprevir+PR, telaprevir+PR, or PR alone) with available data who did not already experience HOI during 3 months preceding CHC treatment regimen. Participants categorized by treatment group of exposure further described in Arm Description||events per 1000 participant-days||95% Confidence Interval|Number
33478|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid (TC), intravenous (IV) and/or oral (PO) corticosteroids (IV/PO CS), emollients/moisturizers (E/M), antihistamines (AH), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of serious rash episodes managed by a particular intervention are reported out of the total number of managed serious rash episodes with data available for that intervention (i.e. serious rash episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
33479|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention|Serious rash was considered a HOI for this study and included rash > 50% of body surface area, rash associated with significant systemic symptoms, or rash resulting in hospitalization or urgent care visit. Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid use, intravenous (IV) and/or oral corticosteroids, emollients/moisturizers, antihistamines, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of serious rash episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
33480|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin (TPO), platelet transfusion (PT), other treatment (OT) , and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of grade 3/4 thrombocytopenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 thrombocytopenia episodes with data available for that intervention (i.e. grade 3/4 thrombocytopenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
33498|NCT01544348|Secondary|Observed Serum Concentration|Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.|Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85|Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
33481|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 thrombocytopenia (Grade 3: platelet count 25 - <50 × 10^9/L, Grade 4: <25 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin, platelet transfusion, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 thrombocytopenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
33482|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use, other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). More than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of grade 3/4 neutropenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 neutropenia episodes with data available for that intervention (i.e. grade 3/4 neutropenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
33483|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 neutropenia (Grade 3: neutrophil count 0.5 - <0.75 × 10^9/L, Grade 4: <0.5 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 neutropenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
33484|NCT01544582|Primary|Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes|"Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion (BT), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). Interventions could be used in combination (e.g. ESA plus blood transfusion) and more than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of anemia episodes managed by a particular intervention are reported out of the total number of managed anemia episodes with data available for that intervention (i.e. anemia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants||Number
33485|NCT01544582|Primary|Percentage of Anemia Episodes Managed by at Least One Clinical Intervention|Anemia (hemoglobin <10 g/dL) was considered a Health Outcome of Interest (HOI) for this study. Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion, drug dose reduction, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of anemia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).||percentage of episodes|Participants|95% Confidence Interval|Number
33516|NCT01544309|Primary|Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level||Baseline, and 12 months after administration|Participants in full analysis set (FAS) except the ones who had no HDL-C data at 12 months.||Percent change||Standard Deviation|Mean
33758|NCT01541553|Primary|Complete Clearance of AKs at Week 11|To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.|11 weeks|||participants|||Number
33486|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score|The Child-Pugh Score is used to determine the prognosis of chronic liver disease, in particular cirrhosis. It is classified into Classes A (best prognosis) to C (worst prognosis). Child-Pugh scores assessed within 3 months before CHC treatment regimen initiation were recorded from the eCRF, and the number of participants who were Grade A, Grade B, Grade C, not assessed, or unknown whether assessed were reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (Child Pugh score).||participants|||Number
33487|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load|Participant baseline HCV viral load was recorded from the eCRF and categorized as either “Low” (<800,000 IU/mL or <2,000,000 RNA copies/mL) or “High” (≥800,000 IU/mL or ≥2,000,000 RNA copies/mL).|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (viral load).||participants|||Number
33488|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype|Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (HCV genotype).||participants|||Number
33489|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)|Baseline mean body mass index (SD) in Kg/m^2 was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (BMI).||Kg/m^2||Standard Deviation|Mean
33490|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height|Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (height).||centimeters||Standard Deviation|Mean
33491|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight|Baseline mean weight (standard deviation [SD]) in kilograms (Kg) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (weight).||kilograms (Kg)||Standard Deviation|Mean
33492|NCT01544582|Primary|Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)|The percentage of CHC participants initiating boceprevir plus PR treatment, telaprevir plus PR treatment, or PR treatment alone was determined from a Drug Utilization questionnaire that was administered to physicians using an electronic Case Report Form (eCRF) to collect site level information and reported with 95% confidence intervals.|Up to 37 months|Analysis Population: All CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone.||percentage of participants||95% Confidence Interval|Number
33493|NCT01544361|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814||Day 1, 29, 57, 85, and 106|Analyses of immunogenicity was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.|||||
33494|NCT01544361|Secondary|Pharmacokinetic (PK) Parameters of MEDI7814|Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed.|Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106|Analyses of PK was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.|||||
33495|NCT01544361|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Day 1 to Day 106|Safety population included all randomized participants who received MEDI7814 and had safety data available.||Participants|||Number
33496|NCT01544348|Secondary|Free Immunoglobulin E (IgE) Serum Concentration||Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only|Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively.||ng/mL||Standard Deviation|Mean
34072|NCT01536145|Secondary|Multiple Dose Cinf for CP-751,871||1 hour postdose in Cycles 2 up to 16|Multiple dose Cinf data were listed for individual subjects, however were not summarized by descriptive statistics.|||||
33499|NCT01544348|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 to 85|Safety population included all participants who received any amount of investigational product and had safety data available.||participants|||Number
33500|NCT01544309|Secondary|Change From Baseline in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|||μg/mL||Standard Deviation|Mean
33501|NCT01544309|Secondary|Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007|Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.|3 months after administration, the end of starting dose and the end of study treatment|Full analysis set except participants who have reached the target LDL-C level specified at the treatment start||Percentage of participants||95% Confidence Interval|Number
33502|NCT01544309|Secondary|Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation|Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)|Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment||||||
33503|NCT01544309|Secondary|Percent Change in Non-HDL-C Level||Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no non-HDL-C level data at 12 months.||Percent change||Standard Deviation|Mean
33504|NCT01544309|Secondary|Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)||Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no lipids level data at 12 months.||Percent change||Standard Deviation|Mean
33505|NCT01544309|Secondary|Frequency of Serious Adverse Events (SAE)||Up to 12 months|||Number of patients with SAE|||Number
33506|NCT01544309|Secondary|Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)||From the start of the treatment to the end of study treatment|||Number of patients with any events|||Number
33507|NCT01544309|Secondary|Change From Baseline in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.||μU/mL||Standard Deviation|Mean
33508|NCT01544309|Secondary|Percent Change in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa.|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug||Percent change||Standard Deviation|Mean
33509|NCT01544309|Secondary|Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|||mg/dL||Standard Deviation|Mean
33510|NCT01544309|Secondary|Percent Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no blood glucose level data at 12 months.||Percent change||Standard Deviation|Mean
33511|NCT01544309|Secondary|Change in HbA1c Level||Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.||Amount of change (%)||Standard Deviation|Mean
33512|NCT01544309|Secondary|Percent Change in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no 1,5-AG data at 12 months.||Percent change||Standard Deviation|Mean
33513|NCT01544309|Secondary|Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status|“Deterioration of diabetic treatment status” is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.|Baseline, 3, 6, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.||participants|||Number
33514|NCT01544309|Secondary|Occurrence of Deterioration of Diabetic Treatment Status|“Deterioration of diabetic treatment status” is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.|Baseline, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.||Participants|||Number
33515|NCT01544309|Primary|Change in HbA1c Level||Baseline, 12 months after administration|Participants in FAS except the ones who had no HbA1c data at 12 months.||Amount of change (%)||Standard Deviation|Mean
33517|NCT01544179|Secondary|Time to Worsening in Lung Cancer Subscale|A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Weeks||95% Confidence Interval|Median
33518|NCT01544179|Secondary|Improvement in Lung Cancer Subscale|An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Number of participants improving|||Number
33519|NCT01544179|Secondary|Time to Worsening in FACT-L Total Score|A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Weeks||95% Confidence Interval|Median
33520|NCT01544179|Secondary|Improvement in FACT-L Total Score|An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Number of patients improving|||Number
33521|NCT01544179|Secondary|Time to Worsening in Trial Outcome Index|A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Weeks||95% Confidence Interval|Median
33522|NCT01544179|Secondary|Improvement in Trial Outcome Index|An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL||Number of participants improving|||Number
33523|NCT01544179|Secondary|Disease Control Rate (DCR)|DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must have shown an absolute increase of ≥5mm|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set||Percentage of Participants|||Number
33524|NCT01544179|Secondary|Objective Response Rate (ORR) (Site Read Data)|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set||Percentage of Participants|||Number
33525|NCT01544179|Secondary|Median Overall Survival (OS) at Time of PFS Analysis||Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.|Full analysis set||Months||95% Confidence Interval|Median
33526|NCT01544179|Secondary|Overall Survival (OS)|OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.|Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.|Full analysis set||Number of patients with an OS event|||Number
33527|NCT01544179|Primary|Median Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)||Months||95% Confidence Interval|Median
33528|NCT01544179|Primary|Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)||Patients with a progression event|||Number
33860|NCT01539512|Secondary|Complete Response Rate|Complete response rate was defined as the percentage of participants who achieved a complete response.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.||percentage of participants|||Number
33529|NCT01544166|Other Pre-specified|Number of Subjects With Drug Related Serious and Non- Serious Adverse Events|An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a “reasonable causal relationship” to the study treatment.|From baseline to approximately 7 days after injection|SAF included all subjects who received any amount of gadobutrol.||subjects|||Number
33530|NCT01544166|Secondary|Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection|eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k * height / Scr where k = 0.45 in term newborn infants < 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413*height/Scr.|Before gadobutrol injection|"SAF included all subjects who received any amount of gadobutrol. Here n included subjects who were evaluable at specified age group."||milliliter/minute/1.73 square||Standard Deviation|Mean
33531|NCT01544166|Secondary|Number of Subjects With Clinically Significant Abnormal Laboratory Values|Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.|Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection|Safety Analysis Set (SAF) included all subjects who received any amount of gadobutrol.||subjects|||Number
33532|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33533|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33534|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33535|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33536|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33537|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33538|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33539|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33540|NCT01544166|Secondary|Number of Subjects With Final Diagnosis by Body Region|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33541|NCT01544166|Secondary|Number of Subjects With Final Diagnosis|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33542|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis by Body Region|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33543|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33544|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain by Body Region|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33545|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33546|NCT01544166|Secondary|Number of Subjects With Diagnoses by Body Region|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33547|NCT01544166|Secondary|Number of Subjects With Diagnoses|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33548|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33549|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33550|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel by Body Region|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33551|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33552|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel by Body Region|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33553|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33554|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected by Body Region|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.||subjects|||Number
33555|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.||subjects|||Number
33556|NCT01544166|Secondary|Number of Subjects With Presence of Pathology by Body Region|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded. Results per body region were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33557|NCT01544166|Secondary|Number of Subjects With Presence of Pathology|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33558|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality by Body Region|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33559|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33560|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis by Body Region|The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33561|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis|The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33573|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33562|NCT01544166|Secondary|Number of Subjects With Anatomical Area Evaluated|Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.||subjects|||Number
33563|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|30 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. C30 was simulated for 2400 virtual paediatric participants.||micromole/L||Full Range|Median
33564|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|20 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. Here number of subjects analysed= 43. C20 was simulated for 2400 virtual paediatric participants.||micromole/L||Full Range|Median
33565|NCT01544166|Primary|Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual|Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||hours||Full Range|Median
33566|NCT01544166|Primary|Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual|MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||hours||Full Range|Median
33567|NCT01544166|Primary|Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||L/kg||Full Range|Median
33568|NCT01544166|Primary|Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual|Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h*kg).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||L/(h*kg)||Full Range|Median
33569|NCT01544166|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual|AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole*hour per liter (micromole*h/L).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|Per-protocol set (PPS) included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.||micromole*h/L||Full Range|Median
33570|NCT01543958|Secondary|Primary Adverse Events|Number of subjects experiencing primary adverse events, defined as all reported Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities and other serious adverse events (SAEs)|baseline and week 16|All 40 subjects enrolled in A5296 were included in this analysis.||participants|||Number
33571|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33572|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
35466|NCT01516879|Primary|Percent Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set (all randomized subjects who received at least 1 dose of study drug).||percent change||Standard Error|Least Squares Mean
33574|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33575|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from week 8 to week 16|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33576|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33577|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33578|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33579|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33580|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33581|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33582|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33583|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33584|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
33585|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
33586|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
33587|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from week 8 to week 16, where baseline is the average of pre-entry and entry|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
33588|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
33589|NCT01543958|Secondary|Change in C-reactive Protein (CRP)|Changes in levels of systemic inflammation marker CRP from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||ng/mL||Inter-Quartile Range|Median
33590|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33591|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33592|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33593|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||cells/mm^3||Inter-Quartile Range|Median
33594|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||cells/mm^3||Inter-Quartile Range|Median
33595|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||cells/mm^3||Inter-Quartile Range|Median
33596|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||log10(copies/mL)||Inter-Quartile Range|Median
33597|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.||log10(copies/mL)||Inter-Quartile Range|Median
33598|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||log10(copies/mL)||Inter-Quartile Range|Median
33599|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from week 8 to week 16|from week 8 to week 16|Among 40 subjects enrolled in A5296, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33600|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 8|Baseline to Week 8|Among 40 subjects enrolled in A5296, 37 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33601|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 4, where baseline value is the average of pre-entry and entry|from baseline to week 4|Among 40 subjects enrolled in A5296, 39 subjects with valid data at both baseline and week 4 were included in this secondary analysis.||mg/dL||Inter-Quartile Range|Median
33602|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from week 8 to week 16 in cycling CD4+ , defined as the %Ki67+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33603|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 8 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33604|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 4 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33605|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from week 8 to week 16 in cycling CD8+ , defined as the %Ki67+|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33759|NCT01541397|Secondary|Plasma Phenylalanine Levels|Plasma phenylalanine levels will be monitored to determine effectiveness of Kuvan therapy.|weekly for 6 weeks, then at least every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
33606|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 8 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33607|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 4 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33608|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33609|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33610|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change from baseline to week 4 in CD8+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33611|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from week 8 to week 16 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33612|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 4 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33613|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 8 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.||percentage||Inter-Quartile Range|Median
33614|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects had valid data at both week 8 and week 16 and were included in this secondary analysis.||ug/mL||Inter-Quartile Range|Median
33615|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.||ug/mL||Inter-Quartile Range|Median
33616|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid endpoint at both week 8 and week 16 were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33617|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.||pg/mL||Inter-Quartile Range|Median
33618|NCT01543958|Primary|Change in Soluble CD14 (sCD14)|Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.||ug/mL||Inter-Quartile Range|Median
33619|NCT01543958|Primary|Change in Endotoxin|Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.|baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.||pg/mL||Inter-Quartile Range|Median
33620|NCT01543828|Primary|Time (in Minutes) to Patient's Perception of Onset of Effect|"Defined as the first time point that the patient responds yes to the following self-administered question:~I feel that the drug is working in improving my breathing?"|5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2|Full Analysis Set included all participants who received one dose of study drug.||Minutes||Standard Deviation|Mean
33629|NCT01543581|Secondary|Complete Response Rate|A secondary variable is the complete response rate, defined as the proportion of patients with no histological evidence of basal cell carcinoma on the post treatment MMS excision of the target tumor area. For this analysis, the placebo data will be pooled together to calculate the complete response rate for the placebo group.|12 to 14 weeks|||participants|||Number
33621|NCT01543685|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
33622|NCT01543685|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
33623|NCT01543685|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
33624|NCT01543685|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours|Intent to Treat Population||units on a scale*hour||Standard Deviation|Mean
33625|NCT01543685|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
33626|NCT01543685|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
33627|NCT01543685|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
33628|NCT01543685|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent to Treat Population||mm*hour||Standard Deviation|Mean
33630|NCT01543581|Primary|Mohs Micrographic Surgery (MMS)|The final wound size taken immediately after the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) was determined using pre treatment lesion outlined plus one additional concentric 2mm margin removed to establish an objective consistent measure for wound size. The diameter of the final wound size was measured in mm.|The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.|||mm|||Number
33631|NCT01543568|Secondary|Mean Number of 0.2 mg Aflibercept Injections Administered||at 6 months|||injections||Full Range|Mean
33632|NCT01543568|Secondary|Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos||6 Months|Given lack of visual benefit upon switching to aflibercept (Eylea), such analyses were not performed.|||||
33633|NCT01543568|Secondary|Mean Change in Visual Acuity (BCVA)|Change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to month 6. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|6 Months|||ETDRS BCVA letters||Full Range|Mean
33634|NCT01543568|Secondary|The Percentage of Patients Who Lose > 15 Letters Visual Acuity||6 Months|||Percentage of patients|||Number
33635|NCT01543568|Secondary|Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT||6 months|||months||Full Range|Mean
33636|NCT01543568|Secondary|Mean Change in OCT Central Foveal Thickness||6 Months|||micrometers||Full Range|Mean
33637|NCT01543568|Primary|The Number of Patients With no Fluid on OCT||6 months|||participants|||Number
33638|NCT01543503|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|"The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point||scores on a scale||95% Confidence Interval|Least Squares Mean
33639|NCT01543503|Secondary|Shift From Baseline in Morning Stiffness|Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis.||participants|||Number
33640|NCT01543503|Secondary|Mean Change From Baseline in Visual Analogue Scale Pain Score|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||units on a scale||95% Confidence Interval|Least Squares Mean
33641|NCT01543503|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||scores on a scale||95% Confidence Interval|Least Squares Mean
33642|NCT01543503|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||Scores on a scale||95% Confidence Interval|Least Squares Mean
33643|NCT01543503|Secondary|Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.|Up to Week 52|The safety population was used for analysis.||participants|||Number
33644|NCT01543503|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events|An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|The safety population was used for analysis.||participants|||Number
33645|NCT01543503|Secondary|Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy|An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.|Up to Week 52|The safety population was used for analysis.||participants|||Number
33646|NCT01543503|Secondary|Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period|The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as ‘censored’ at the date study termination.|Up to end of treatment|The safety population was used for analysis.||participants|||Number
33647|NCT01543503|Secondary|Reasons for Treatment Discontinuation|The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.|Up to Week 52|The safety population was used for analysis.||participants|||Number
33648|NCT01543503|Secondary|Proportion of Participants Who Terminated Biologic Treatment|The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.|Up to Week 52|The safety population was used for analysis.||Percentage of participants|||Number
33649|NCT01543503|Secondary|Loss of Efficacy or Development of Intolerance to Biologic Therapy|Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.|Up to Week 52|The safety population included all recruited participants who received at least one dose of a TNF inhibitor or tocilizumab during the study.||participants|||Number
33650|NCT01543503|Secondary|Mean Change From Baseline in Physician Global Assessment Score|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||scores on a scale||95% Confidence Interval|Least Squares Mean
33651|NCT01543503|Secondary|Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score|Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||units on a scale||95% Confidence Interval|Least Squares Mean
33652|NCT01543503|Secondary|Mean Change From Baseline in Tender Joint Count|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||Number of tender joints||95% Confidence Interval|Least Squares Mean
33653|NCT01543503|Secondary|Mean Change From Baseline in Swollen Joint Count|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||Number of swollen joints||95% Confidence Interval|Least Squares Mean
33654|NCT01543503|Secondary|Mean Change From Baseline in C-reactive Protein|Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point||mg/L||95% Confidence Interval|Least Squares Mean
33655|NCT01543503|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate|Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.||mm/hr||95% Confidence Interval|Least Squares Mean
33656|NCT01543503|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient’s Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 52|The effectiveness analysis population was used for analysis. Data of participants available at the time of the assessment were included in the analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
33771|NCT01541254|Secondary|Unplanned Embolization Coiling Within 6 Months|If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.|Day 1-6 months||||||
33657|NCT01543503|Primary|Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient’s Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|Participants belonging to the safety population who had first biologic administration within 60 days after the last Rheumatoid Arthritis (RA) disease activity assessment were included in the effectiveness analysis population. Data of participants available at the time of the assessment were included in the analysis.||Units on a scale||95% Confidence Interval|Least Squares Mean
33658|NCT01543204|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.|From first dose of study drug until 30 days after the last dose (up to 28 weeks)|Primary analysis set||participants|||Number
33659|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Flaking|The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating “no flaking at all” and 10 indicating “worst flaking imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
33660|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Pain|The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating “does not hurt at all” and 10 indicating “worst hurt imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
33661|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Itch|The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating “no itch at all” and 10 indicating “worst itch imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
33662|NCT01543204|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI)|The impact of disease severity on the participant’s ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value and who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
33663|NCT01543204|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value – Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.||units on a scale||Standard Deviation|Mean
33664|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 24|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33665|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 12|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 12|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33691|NCT01543074|Primary|Cmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. Cmax (mean +/- SD) values are shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.|||micromoles/L||Standard Deviation|Mean
33772|NCT01541254|Secondary|Device and Procedure Related Serious Adverse Events|All Serious Adverse events will be reported per protocol|Day 1-6months(± 4 months)||||||
33666|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percent change||Standard Deviation|Mean
33667|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percent change||Standard Deviation|Mean
33668|NCT01543204|Secondary|Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percent change||Standard Deviation|Mean
33669|NCT01543204|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percent change||Standard Deviation|Mean
33670|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
33671|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33672|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
33673|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33674|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
33675|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33676|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
33677|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33678|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
33679|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33680|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||units on a scale||Standard Deviation|Mean
33681|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
33682|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
33683|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33684|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with available data||percentage of participants||95% Confidence Interval|Number
33685|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.||percentage of participants||95% Confidence Interval|Number
33686|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set with available data||percentage of participants||95% Confidence Interval|Number
33687|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set (all participants who received at least one dose of investigational product during the study) with at least 1 post-baseline value. Participants with missing post-baseline data were imputed using the last observation carried forward (LOCF) method.||percentage of participants||95% Confidence Interval|Number
33688|NCT01543178|Primary|Repeat Treatment Responders|Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.|4-week treatment-free follow-up in double-blind repeat treatment phase.|Intent-to-treat population, defined as patients who received ≥ 1 dose of study drug in the double-blind period.||percentage of patients|||Number
33689|NCT01543074|Primary|Tmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. The time to achieve highest plasma concentration (Tmax) is shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.|||hours||Standard Deviation|Mean
33690|NCT01543074|Secondary|Histone Acetylation|Change in histone acetylation|21 days||||||
33692|NCT01542957|Secondary|Change From Baseline in Hamilton-Depression Rating Scale-17 Items|This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.|End of therapy|||units on a scale||Standard Deviation|Mean
33693|NCT01542957|Primary|Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy|To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.|End of therapy (16 weeks)|||units on a scale||Standard Deviation|Mean
33694|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set who had an end-of-treatment response (HCV RNA < LLOQ as the last observed on-treatment value) were analyzed.||percentage of participants|||Number
33695|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values|Baseline to Week 12|Full Analysis Set||percentage of participants|||Number
33696|NCT01542788|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Post-treatment Week 24|Full Analysis Set||percentage of participants|||Number
33697|NCT01542788|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Post-treatment Week 4|Full Analysis Set||percentage of participants|||Number
33698|NCT01542788|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.|Baseline to Week 12|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug||participants|||Number
33699|NCT01542788|Primary|Percentage of Participants Achieving SVR12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy|Post-treatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
33700|NCT01542684|Primary|Overall Response Rate (ORR)|ORR is percentage total participants with overall response (Complete Response (CR) or Partial Response (PR)) within two treatment cycles. Response based on modified International Working Group (IWG) criteria: Complete response - Bone marrow: 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia noted, Peripheral blood Hgb 11 g/dL, Platelets 100x109/L, Neutrophils 1.0x109/L, Blasts 0%. Partial response: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by 50% over pretreatment but still > 5% , Cellularity and morphology not relevant; Stable disease - Failure to achieve at least PR, but no evidence of progression for > 8 weeks; No Response or Failure - Death during treatment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS French-American-British (FAB) classification subtype than pretreatme|Baseline up to 2 treatment cycles (8 weeks)|||percentage of participants|||Number
33701|NCT01542645|Secondary|Marker of Myocardial Injury (Troponin I)|In a cohort of patients undergoing only coronary artery bypass graft surgery (n=75), serum troponins will be measured postoperatively to determine whether methadone has a potential cardioprotective effect.|12 hours after surgery|||nanograms per millimeter||Full Range|Median
33702|NCT01542645|Secondary|Chronic Postoperative Pain Scores||1,3,6, and 12 months after surgery||||||
33703|NCT01542645|Secondary|Postoperative Pain Scores|Pain was assessed on a 11-point verbal analogue scale with 0=no pain, 10=worst pain imaginable|2 hours after cardiac surgery|||units on a scale||Full Range|Median
33704|NCT01542645|Primary|Total Opioid Consumption in the Postoperative Period|Total intravenous morphine used first three days (72 hours after ICU admission)|First 3 days after surgery|||milligrams||Full Range|Median
33705|NCT01542632|Primary|Rate of Seroconversion to Each of Four Dengue Serotypes|Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Up to 30 days after the last immunization (Up to Day 120)|Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.||percentage of participants|||Number
33706|NCT01542632|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 30, 90 and 120 after 1st vaccination|Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point.||titer||Standard Deviation|Geometric Mean
33707|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.||participants|||Number
33708|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.||participants|||Number
33709|NCT01542632|Secondary|Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations|Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.|various timepoints up to 30 days after each dose (Up to Day 120)|Full Analysis Set included all enrolled participants.||percentage of participants|||Number
33710|NCT01542632|Primary|Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported|Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.|Day 0 to Day 104|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
33711|NCT01542541|Secondary|SUVavg in Each Colonic Segment||Day 2||||||
33712|NCT01542541|Primary|SUVmax of FDG in Each Colonic Segment||Day 2|||SUV||Standard Deviation|Mean
33713|NCT01542502|Other Pre-specified|Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope)|Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.|14 days||||||
33714|NCT01542502|Other Pre-specified|Inflammatory Biomarkers|Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.|28 days||||||
33715|NCT01542502|Other Pre-specified|Adverse Events|Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.|28 days||||||
33716|NCT01542502|Other Pre-specified|Heart Failure Symptoms (DASI)|Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.|28 days||||||
33717|NCT01542502|Other Pre-specified|Correlation Between Endpoints|Correlation between interval change in peak VO2 and high sensitivity C-reactive protein|28 days||||||
33718|NCT01542502|Secondary|Exercise Time|Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment|14 days|||minutes||Inter-Quartile Range|Median
33719|NCT01542502|Primary|Peak Oxygen Consumption (Peak VO2)|The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).|14 days|||ml*kg^-1*min^-1||Inter-Quartile Range|Median
33720|NCT01542255|Secondary|Clinical Response Rate|To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol|Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met.||||||
33721|NCT01542255|Primary|Progression Free Survival|Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.|From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months|||weeks||Full Range|Median
33722|NCT01542125|Primary|Pain|"A horizontal 100 mm anchored Visual Analogue Scale (0 = no pain, 100 = worst possible pain) was used by the adult caregiver and the orthopedic technician to document the pain associated with Perc Pin removal for participant children.~The Oucher Scale was used to assess pain intensity in participant children and included two separate scales. 6 photographs were assigned scores of 0, 20, 40, 60, 80, and 100 (in increasing increments of pain), such that these would be the scores averaged for participants unable to count by number. Children able to count to 100 by ones or tens and who could identify the larger of 2 numbers used the second scale; a vertical numeric one (0–100) that was printed next to the faces."|Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes|||units on a scale||Standard Deviation|Mean
33723|NCT01542034|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||units on a scale||Standard Deviation|Mean
33724|NCT01542034|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.||percentage of participants|||Number
33725|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0–4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0–4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
33726|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0–4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0–4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.||percentage of participants|||Number
33727|NCT01541969|Secondary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 10' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 36 weeks (visit 10)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 36 weeks (visit 10). Here we report complete case data.||units on a scale||Standard Deviation|Mean
33728|NCT01541969|Secondary|Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG)|"Non-invasive recording to measure rhythmic patterns of spontaneous brain activity at rest. An a priori hypothesis targeted normalized delta rhythm. Band powers were calculated as percent change in delta brainwave pattern relative to change in total (1-90 Hz) EEG band. Comparison made between 'visit 2' and 'visit 6'.~We used a Neuroscan system (SynAmps2 model 8050, Compumedics Neuroscan, Charlotte, NC, USA) and custom cap with 66 equidistant scalp electrodes (Easycap, GmbH, Germany). A central frontal electrode was used as ground and a nose-tip electrode as reference. Electrode impedances were maintained at 5 kΩ prior to recordings. Recording was done with an offline filter of 0.5 to 200 Hz pass-band and 1 kHz sampling rate. Recording was over a continuous 10-minute period. Participants were seated in a quiet, darkened soundproof booth and were instructed to relax, keep eyes open and fix gaze on a marker point."|Baseline (visit 2) and 12 weeks (visit 6)|The EEG assessment was offered only to the first 50 participants enrolled at the Nottingham site. We have analyzed only complete case data for the mean change in delta band power from baseline (visit 2) to 12 weeks (visit 6).||Percent change||Standard Deviation|Mean
33729|NCT01541969|Secondary|World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)|The WHOQOL-BREF is a 26-item, multi-attribute questionnaire measure of health related quality of life. Outcome was measured as a change on Question 1: 'How would you rate your quality of life (over the past 4 weeks)?' There are 5 response options (Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction in self-perceived quality of life.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in Q1 score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
33730|NCT01541969|Secondary|Tinnitus Functional Index (TFI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global TFI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
33731|NCT01541969|Secondary|Tinnitus Handicap Inventory (THI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
33732|NCT01541969|Primary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.||units on a scale||Standard Deviation|Mean
33733|NCT01541930|Secondary|Pain (Visual Analogue Scale)|The pain linked to the fungating tumour over the last 24 hours was evaluated by the patient. The pain was graded using a 100 mm linear visual analogical scale (graded from 0 mm = no pain to 100 mm = severe pain).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||mm||Standard Deviation|Mean
33734|NCT01541930|Secondary|Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)|Appearance score was evaluated by the Study Investigator using the following scale; 0: None (No discharge, e.g. frequency of dressing change: once daily), 1: Mild (Dressing need to be Changed twice daily), 2: Moderate (Dressing need to be Changed 3 times daily), 3: Marked (Dressing need to be Changed >3 times daily / Bloody).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
33735|NCT01541930|Secondary|Smell Score by Patient|Tumour smell score was evaluated by the Patient using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
33736|NCT01541930|Secondary|Smell Score by Nurse|Tumour smell score was evaluated by the Nurse using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
33737|NCT01541930|Secondary|Smell Score by Investigator|Tumour smell score was evaluated by the Study Investigator using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell, 3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.||participants|||Number
33738|NCT01541930|Primary|The Success Rate|The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator|at Day 14 (end of treatment)|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. Only observed cases were part of the analyses. If the primary endpoint was missing, an additional analysis of this endpoint was performed using the last observation carried forward (LOCF) to impute the missing data.||percentage of participants||90% Confidence Interval|Number
33739|NCT01541865|Secondary|Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.||participants|||Number
33740|NCT01541865|Secondary|Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||participants|||Number
33741|NCT01541865|Secondary|Chronic Symptomatic Orthostatic Hypotension||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||participants|||Number
33742|NCT01541865|Secondary|Angiographically-documented Renal Stenosis Requiring an Intervention||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||participants|||Number
33743|NCT01541865|Secondary|Sudden Cardiac Death at Time of Procedure||Duration of the procedure (average of 65 minutes)|||participants|||Number
33744|NCT01541865|Secondary|Myocardial Infarction at Time of Procedure||Duration of the procedure (average of 65 minutes)|||participants|||Number
33745|NCT01541865|Secondary|Cerebrovascular Accident (CVA) at Time of Procedure||Duration of the procedure (average of 65 minutes)|||participants|||Number
33746|NCT01541865|Secondary|Renal Artery Infarction or Embolus||Duration of the procedure (average of 65 minutes)|||participants|||Number
33747|NCT01541865|Secondary|Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery||Duration of the procedure (average of 65 minutes)|||participants|||Number
33748|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure|Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment.||mm Hg||Standard Deviation|Mean
33749|NCT01541865|Secondary|Absence of Flow Limiting Stenosis in the Renal Artery|Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.||participants w/o flow limiting stenosis|||Number
33750|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment|Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.||mm Hg||Standard Deviation|Mean
33751|NCT01541735|Primary|Total Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion|Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)|||µU/ml||Standard Deviation|Mean
33752|NCT01541735|Primary|Second Phase of Insulin Secretion|Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)|Baseline and 45 day|||µU/ml||Standard Deviation|Mean
33753|NCT01541735|Secondary|Glycated Hemoglobin A1C||Change from Baseline in glycated hemoglobin A1C at 45 day.|||percentage||Standard Deviation|Mean
33754|NCT01541735|Primary|First Phase of Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.|Change from Baseline at 45 days. (plus or minus 3 days)|The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial||µU/ml||Standard Deviation|Mean
33755|NCT01541644|Primary|To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)|The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians & the TNSc in our trial was performed by a research nurse. The reliability & validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.|Baseline and 10 weeks|||units on a scale (1 - 100)||Standard Deviation|Mean
33773|NCT01541254|Secondary|Stent Migration at 6 Months|Angiographic images will be comparing post procedure sent position to 6 months|6 months||||||
33760|NCT01541397|Secondary|Diet Analysis|Subjects will provide a 3 day diet record for every plasma amino acid evaluation. Diets will be analyzed to determine phenylalanine, protein, calories, fat, vitamins and minerals.|every 3 months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
33761|NCT01541397|Secondary|Plasma Amino Acid Profile|Evaluation of levels of plasma amino acids.|every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
33762|NCT01541397|Primary|Bone Mineral Density|A DXA scan will be conducted one year after Kuvan therapy is initiated.|1 year after initiation of Kuvan therapy|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).|||||
33763|NCT01541371|Secondary|Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12|The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."||mm||Standard Deviation|Mean
33764|NCT01541371|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."||Participants|||Number
33765|NCT01541371|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =<30, functioning so poorly as to require intensive supervision.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
33766|NCT01541371|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."||units on a scale||Standard Deviation|Mean
33767|NCT01541371|Secondary|Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Percentage of participants with at least 20 percent improvement of PANSS total score was measured.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||Percentage of participants||95% Confidence Interval|Number
33768|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
33769|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
33770|NCT01541371|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.||unit on a scale||Standard Deviation|Mean
33777|NCT01541254|Primary|Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months|A major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥ 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.|30 days-6 months|||patients|||Number
33778|NCT01541254|Primary|Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)|Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.|6 months ± 4 weeks|||percent occlusion of aneurysm||Standard Deviation|Mean
33779|NCT01540981|Secondary|Change in Mean Wound Area|Measured from randomization to last visit (14 days or at discharge from hospital)|14 days|||square centimeters||Standard Deviation|Mean
33780|NCT01540981|Primary|Effectiveness|"To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue).~Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy"|14 days|||participants|||Number
33781|NCT01540851|Secondary|Range of Motion|Percentage of participants able to bend knee at least 120 degrees|6 months after TKA|Percentage of participants who self-reported on their 6 month questionnaire that they were able to bend their index knee to greater than 120 degrees||percentage of participants|||Number
33782|NCT01540851|Secondary|Satisfaction|Percentage of patients in each study arm who reported being very satisfied with the results of TKA|Measured at 6 months post TKA|The proportion of participants who reported being very satisfied with the results of TKA was assessed using a 5-item Likert scale on the 6 month follow-up questionnaire||percentage of participants|||Number
33783|NCT01540851|Primary|Change in WOMAC Physical Function|The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months|Change in functional status from baseline to 6 months|The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst. Change in function was calculated as the WOMAC Physical Function score at 6 months minus the WOMAC Physical Function score at baseline||units on a scale||95% Confidence Interval|Mean
33784|NCT01540825|Primary|Assessment of Tolerability by the Investigator|Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.|End of study visit, up to day 10|Treated set||Percentage of participants|||Number
33785|NCT01540825|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study visit, up to 10 days|Treated set||Percentage of participants|||Number
33786|NCT01540825|Secondary|t1/2|Terminal half-life of the analyte in plasma (t1/2)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||Hours||Geometric Coefficient of Variation|Geometric Mean
33787|NCT01540825|Secondary|AUC0-infinity|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
33788|NCT01540825|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
33789|NCT01540825|Secondary|Tmax|Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||Hours||Full Range|Median
33790|NCT01540825|Secondary|Cmax|"Maximum measured concentration of the analyte in plasma (Cmax).~The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK."|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
33791|NCT01540825|Primary|Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test|Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test|From administration of study drug until end-of-study visit, up to 10 days|Treated set||Percentage of participants|||Number
33792|NCT01540487|Secondary|AUC0-tz for Linagliptin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
33793|NCT01540487|Secondary|AUC(0-infinity) for Metformin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
35467|NCT01516749|Secondary|Change in C-reactive Protein|Change assessed from baseline to end of treatment phase.|Baseline, 8 weeks|Patients who completed 8 weeks of therapy||mg/L||95% Confidence Interval|Mean
33794|NCT01540487|Secondary|Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
33795|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Metformin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
33796|NCT01540487|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
33797|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Linagliptin.||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
33798|NCT01540487|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
33799|NCT01540370|Primary|Inter- Examiner Agreement in Angle Width by Goniometric Lens|Inter-rater agreement (among 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)||Kappa statistics|||Number
33800|NCT01540370|Primary|Intra- Examiner Agreement in Angle Width by Goniometric Lens|Intra-rater agreement (for each of the 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)||Kappa statistics|||Number
33801|NCT01540266|Secondary|Estimates of the Current Status||5 minutes||||||
33802|NCT01540266|Secondary|Estimates of the Quality of the Communication||5 minutes||||||
33803|NCT01540266|Primary|Number of Items Recalled From the Communication in the Video|The students in the structured condition and the students in the non-structured condition were independently shown a video in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form. The key memory measure of interest was immediate recall performance expressed as the number of items recalled from the overall 28 items in the two videos. Participants’ recall protocols were evaluated by two independent raters, one of whom rated all protocols and the other, only a subset of them. Analyses of the agreement between the two raters resulted in a Cohen’s kappa of 0.74, indicating substantial interrater reliability according to Landis and Koch (35). In case of disagreement between the two raters, consensus was reached through joint analysis and discussion of the protocols.|5 minutes|||number of items recalled||Standard Deviation|Mean
33804|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 12 month of life|||participants|||Number
33805|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 6 month of life|||participants|||Number
33806|NCT01540162|Primary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 28 days of life|||participants|||Number
33807|NCT01540045|Primary|Dysgeusia (BITTER Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes|pre - post chemotherapy (6 weeks)|||participants|||Number
33808|NCT01540045|Primary|Dysgeusia (SWEET Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.|pre - post chemotherapy (6 weeks)|we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy||participants|||Number
33809|NCT01540045|Primary|Dysgeusia (UMAMI Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)|pre - post chemotherapy (6 weeks)|||participants|||Number
33810|NCT01540045|Primary|Dysgeusia (BITTER Recognition)|"Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Median
33861|NCT01539512|Secondary|Overall Survival|Overall survival was defined as the interval from randomization to death from any cause.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.||months||95% Confidence Interval|Median
33811|NCT01540045|Primary|Dysgeusia (BITTER Perception)|"Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Mean
33812|NCT01540045|Primary|Dysgeusia (SWEET Recognition)|"Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Median
33813|NCT01540045|Primary|Dysgeusia (SWEET Perception)|"Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||μmol/ml||Full Range|Median
33814|NCT01540045|Secondary|Global Status of Quality of Life (C-30,LC13 EORTC)|"differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste.~score of scale 0-100, a higher score represents better overall state."|time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks|||units on a scale||Inter-Quartile Range|Median
33815|NCT01540045|Secondary|Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)|comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks|||Units on a scale||Full Range|Median
33816|NCT01540045|Secondary|Change From Baseline in Albumin After 2 Cycles of Chemotherapy|comparison of patients who increased or decreased their sensibility to the PT of umami taste|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||g/dL||Standard Deviation|Mean
33817|NCT01540045|Secondary|Quality o f Life|The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||Scores on a scale||Full Range|Median
33818|NCT01540045|Primary|Dysgeusia (UMAMI Recognition)|"Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||μmol/ml||Full Range|Median
33819|NCT01540045|Secondary|IRON Consumption|IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||mg||Standard Deviation|Mean
33820|NCT01540045|Secondary|PROTEIN AND FAT Consumption|energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks|||gr||Standard Deviation|Mean
33821|NCT01540045|Secondary|Subjective Global Assessment|validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).|descriptive values before chemotherapy|||participants|||Number
33822|NCT01540045|Secondary|Body Mass Index|Body mass index, using the formula kg/m^2|Change from Baseline in threshold of perception and recognition at 6 weeks|||kg/m^2||Standard Deviation|Mean
33823|NCT01540045|Secondary|BODY COMPOSITION|fat mass and lean body mass pre-post chemotherapy|Change from Baseline in perception and recognition thresholds at 6 weeks|||kg||Standard Deviation|Mean
33862|NCT01539512|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization||percentage of participants||95% Confidence Interval|Number
33824|NCT01540045|Primary|Dysgeusia (UMAMI Perception)|"Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|||μmol/ml||Full Range|Median
33825|NCT01539980|Secondary|Liver Enzyme (AST)|Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased.|Within 14 days after operation|||u/L||Standard Deviation|Mean
33826|NCT01539980|Secondary|Proinflammatory Cytokines (IL)|The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.|Within 14 days after operation|||pg/mL||Standard Deviation|Mean
33827|NCT01539980|Secondary|Pain Levels of Wounds|Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.|Within 14 days after operation|||units on a scale||Standard Deviation|Mean
33828|NCT01539980|Secondary|Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Number of patients with infected wound|Within 14 days after operation|||Number of patients with infected wound|||Number
33829|NCT01539980|Primary|Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.|Within 14 days after operation|||Days||Standard Deviation|Mean
33830|NCT01539811|Secondary|Length of Antibiotics|Length of antibiotic|6 weeks||||||
33831|NCT01539811|Secondary|Hospital Stay|Length of hospital stay, total cost of hospital stay|2 weeks||||||
33832|NCT01539811|Secondary|Clearance of Infection|Clearance of infection (as determined by negative culture, normal complete blood count (CBC), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP)|6 weeks||||||
33833|NCT01539811|Secondary|Reinfection/Reintervention|Reinfection or Reintervention to the operative site|3 months||||||
33834|NCT01539811|Primary|Wound Healing|Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.|3 months||||||
33835|NCT01539759|Secondary|Women's Satisfaction With IUDs||0-6 months postpartum||||||
33836|NCT01539759|Secondary|IUD Expulsion||0-6 months postpartum|||participants|||Number
33837|NCT01539759|Primary|IUD Use|The use of an IUD at 6 months postpartum is the primary outcome measure|6 months postpartum|||participants|||Number
33838|NCT01539642|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326.~Time-weighted SPID48 = ∑ [T(i) – T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours.~Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one active patient receiving placebo inadvertently."|48 hours|||Units on a scale||Standard Error|Least Squares Mean
33839|NCT01539590|Secondary|Symptoms and Clinical Signs of CHF|Symptoms and clinical signs of CHF measured by NYHA classification|6 months||||||
33840|NCT01539590|Secondary|Change in Body Weight||6 months||||||
33841|NCT01539590|Secondary|Change From Baseline eCrCl||6 months||||||
33842|NCT01539590|Secondary|Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia||6 months||||||
33843|NCT01539590|Secondary|All-cause Mortality||6 months||||||
33844|NCT01539590|Secondary|Frequency of MACCE||6 months||||||
33845|NCT01539590|Secondary|Frequency of AE, SAEs||6 months||||||
33846|NCT01539590|Secondary|Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram||6 months||||||
33847|NCT01539590|Secondary|Number of Hospitalizations for CHF Through 6 Months||6 months||||||
33848|NCT01539590|Secondary|Frequency of New Onset CHF Through 6 Months||6 months||||||
33849|NCT01539590|Secondary|Frequency of MACE||6 months||||||
33850|NCT01539590|Secondary|Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain||1 and 6 months||||||
33851|NCT01539590|Secondary|Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography||1 and 6 months||||||
33852|NCT01539590|Secondary|LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography||6 months||||||
33853|NCT01539590|Secondary|Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)||6 months||||||
33854|NCT01539590|Secondary|Change in Symptoms and Clinical Signs of CHF||6 months||||||
33855|NCT01539590|Secondary|Change in BNP Levels||6 months||||||
33856|NCT01539590|Secondary|Change in CK-MB and Troponin||6 months||||||
33857|NCT01539590|Primary|Evaluation of the Degree of Late Ventricular Remodeling|Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).|6 months||||||
33858|NCT01539590|Primary|Evaluation of Reduction in Infarct Size|Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage|6 month|Five subjects were enrolled into the study; 3 subjects were randomized to BB3 and 2 subjects to placebo. Of the 3 subjects randomized to BB3, 1 completed study treatment; all three subjects discontinued the study prematurely. The two subjects randomized to placebo completed study treatment and neither discontinued the study prematurely.|||||
33863|NCT01539512|Secondary|Overall Response Rate|"Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.~Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.~Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors."|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.||percentage of participants||95% Confidence Interval|Number
33864|NCT01539512|Primary|Progression-Free Survival|Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.|Up to 17 months|Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization.||months||95% Confidence Interval|Median
33865|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 3|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 3 (End of Study)|Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days.||Units on a scale||Inter-Quartile Range|Mean
33866|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 2|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 2 (Week 4)|Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days.||Units on a scale||Inter-Quartile Range|Mean
33867|NCT01539317|Primary|Location of Pain in Postmenopausal Dyspareunia|"To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0=no pain and 10=the worst pain you have ever felt."|Enrollment visit|||units on a scale from 0 to 10||Inter-Quartile Range|Median
33868|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 1|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 1 (Enrollment)|Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.||units on a scale||Inter-Quartile Range|Mean
33869|NCT01539317|Primary|Prevention of Entry Dyspareunia With Non-hormonal Therapy|"Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being no pain and 10 being worst possible pain). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase."|During Phase II (0-4 weeks) and during Phase III (5-12 weeks)|||Units on a scale||Inter-Quartile Range|Mean
33870|NCT01539135|Secondary|Number of Participants With Unanticipated Intensive Care Unit Admission|Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.|Time from discharge from PACU to discharge from hospital up to 72 hours|||participants|||Number
33871|NCT01539135|Secondary|Number of Participants With Postoperative Pneumonia|Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery|Up to 30 days after surgery|||participants|||Number
33872|NCT01539135|Secondary|Length of Hospital Stay|Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.|Time from discharge from PACU to discharge from hospital up to 72 hours|||hours||Standard Deviation|Mean
33873|NCT01539135|Primary|Number of Participants With Dye Leakage|Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.|Duration of surgical procedure - from 2 to 12 hours|||participants|||Number
33874|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase|Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.|Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.||units on a scale||Standard Deviation|Mean
33875|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase|The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).|Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.||units on a scale||Standard Deviation|Mean
33876|NCT01539083|Secondary|Consolidation Phase: Overall Survival (OS)|OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.|Up to 3 years|All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment.||months||95% Confidence Interval|Median
33877|NCT01539083|Secondary|Consolidation Phase: Disease-free Survival (DFS)|DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).|Up to 3 years|Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, ‘N’ (number of participants analyzed) signifies the participants who had complete response.||months||95% Confidence Interval|Median
33878|NCT01539083|Secondary|Consolidation Phase: Progression Free Survival (PFS)|PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|Baseline until progressive disease (up to 3 years)|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||months||95% Confidence Interval|Median
33879|NCT01539083|Secondary|Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12|sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||percentage of participants|||Number
33880|NCT01539083|Secondary|Consolidation Phase: Pecentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||percentage of participants|||Number
33881|NCT01539083|Primary|Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours.|Month 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.||percentage of participants|||Number
33882|NCT01539070|Primary|Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment|In order to calculate children’s BMI and age and sex specific BMI z-scores at baseline and 3 month follow-up, study staff assessed child’s height in meters and weight in kilograms. BMI was calculated as weight in kilograms divided by the square of height in meters.|0, 3 month|||z score||Standard Error|Mean
33883|NCT01539070|Secondary|Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group|We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.|3 months|||participants|||Number
33884|NCT01539070|Primary|Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment|Staff assisted parents in reporting the average time the participating child spent in pre-specified active and sedentary activities during the week and on weekends. For each of the pre-specified activities parents reported time spent in open-ended response format. From these responses we derived total hours/week of physical activity composed of active play (e.g. running, jumping, walking, playing ball, playing in the park, biking, swimming, dancing), as well as total hours/week of screen time, composed of television, DVD/video, and video and computer games.|0, 3 months|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 and to 6 months between the intervention and usual care groups.||hours/week||Standard Deviation|Mean
33885|NCT01539070|Primary|Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment|We asked parents about the average number of servings in the week or month the child consumed each food. We constructed grouped diet variables corresponding to food categories : sweet snacks (sugar-sweetened dairy, sugary cereal, cookies, sweet bread, cake, packaged pastries ], caramel pops, candies and chocolates); fast food (hamburgers, pizza, hot dogs, quesadillas, fried tacos, French fries); savory snacks (packaged snack foods, corn or potato chips); fruit (orange, mango, papaya, watermelon, grapes, apple, banana); vegetables (chard, broccoli, jitomate [tomato], nopales [cactus], chayote [squash], spinach, lettuce, zucchini, carrot); sugar-sweetened beverages (soda, flavored milk, homemade [agua fresca] and packaged fruit drinks); and added sugar in beverages (teaspoons sugar or sweet flavoring added to milk, coffee, tea, or fruit juice).|0, 3 months|Intent-to-treat analyses with multiple imputation to account for missing data. Were included in the analysis of children between 0 and 3 BMI z score, age between 24 and 59 months and parents signed letter of consent to participate in the study||servings/week||Standard Error|Mean
33886|NCT01538472|Primary|3-Year Overall Survival|Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.|3 years|||percentage of participants|||Number
33887|NCT01538472|Primary|Overall Survival Median|Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.|Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)|||days||Full Range|Median
33888|NCT01537900|Secondary|Plasma t½ of GZR|t1/2 is a measure of time for the maximum plasma concentration of GZR to decrease by 50%.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
33889|NCT01537900|Secondary|Time to Maximum Plasma Concentration (Tmax) of GZR|Tmax is a measure of time to reach maximum post-dose plasma drug concentration.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
33890|NCT01537900|Secondary|Lowest Plasma Concentration (Ctrough) of GZR|Ctrough is a measure of drug concentration 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
33891|NCT01537900|Secondary|Maximum Plasma Concentration (Cmax) of GZR|Cmax is a measure of the maximum plasma concentration post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
33892|NCT01537900|Secondary|Plasma AUC[0-24 hr] of GZR|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.|||||
33893|NCT01537900|Primary|Apparent Terminal Hepatic Half-life (t[H]½ ) of GZR|t(H)1/2 is a measure of the time required for the maximum post-dose liver concentration of GZR to decrease by 50%.|4, 8, 24, and 72 hours post-dose on Day 7|Apparent t(h)1/2 could not be estimated due to insufficient data in the terminal phase.|||||
33894|NCT01537900|Primary|Hepatic Concentration of GZR (C[H]Xhr)|C(H)Xhr of GZR was expressed as liver concentration (μmol GZR/L liver) using the concentration of the extracted liver sample (mass of the liver biopsy/0.2 mL solvent), and assuming that liver has the specific gravity of water (1 g/mL). The arithmetic mean C(H)Xhr concentration is based on the means of 4 FNA passes per participant in all 4 participants.|4, 8, 24, and 72 hours post-dose on Day 7|The PPP includes all participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment.||µM||Standard Deviation|Mean
33895|NCT01537900|Primary|Estimated Area Under the Liver Concentration-time Curve for 24 Hours Post-dose (AUC[H]0-24hr) of Grazoprevir|Each participant was assigned to undergo Fine Needle Aspiration (FNA) to obtain liver tissue at different time points. Specifically, one participant underwent FNA at 4 hr post-dose only, another participant underwent FNA at 8 hr post-dose only, and a third participant underwent FNA at 24 hr post-dose only. (The fourth participant underwent FNA at 72 hr post-dose and therefore was not included in the calculation of AUC0-24hr.) Therefore, in calculating AUC0-24hr, there were only 3 data points: 1 data point at 4 hr post-dose, 1 data point at 8 hr post-dose, and 1 data point at 24 hr post-dose. The model assumed that drug concentration was at steady-state, and that the concentration at 24 hr post-dose was equal to the concentration at 0 hr post-dose.|4, 8, and 24 hours post-dose on Day 7|The per protocol population (PPP) includes all participants (4, 8, and 24 hr time points) who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment. As each data point was obtained from unique participants, there is no measure of variability.||µM*hr|||Number
33896|NCT01537835|Secondary|Assess for Methicillin Resistent Staphylococcus Aureus, Vancomycin Resistant Enterococci, and Gram-negative Bacterial Contamination on Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform.|Number of healthcare workers with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and resistant gram-negative bacteria on the three scrub types, all obtained after the eight-hour workday.|8 hours|Healthcare workers randomized to one of three types of uniform||participants|||Number
33897|NCT01537835|Primary|Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.|Total bacterial colony count of samples obtained from the breast or lower front pocket, the sleeve cuff of the dominant hand and the pant leg at the mid-thigh of the dominant leg on all scrubs after an eight-hour workday.|8 hours|healthcare workers randomized to one of three types of uniform.||colony formation units||Inter-Quartile Range|Median
33898|NCT01537666|Secondary|Lung Pharmacokinetics - Minimum Sputum Concentration (Cmin)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.~Cmin is the minimum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.||µg/ml||Standard Deviation|Mean
33899|NCT01537666|Secondary|Lung Pharmacokinetics - Maximum Sputum Concentration (Cmax)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.~Cmax is the maximum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.||µg/ml||Standard Deviation|Mean
33900|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUCinf)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~AUCinf is a way of estimating the total amount of drug exposure over an infinite time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||h*ng/ml||Standard Deviation|Mean
33901|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~AUCt is a way of expressing the total amount of drug exposure over a specified time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||h*ng/ml||Standard Deviation|Mean
33902|NCT01537666|Secondary|Plasma Pharmacokinetics - Maximum Plasma Concentration (Cmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Cmax is the maximum observed concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||ng/ml||Standard Deviation|Mean
33903|NCT01537666|Secondary|Plasma Pharmacokinetics - Time to Reach the Maximum Plasma Concentration (Tmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Tmax is the time it takes to reach the maximum plasma concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||Hours||Standard Deviation|Mean
33904|NCT01537666|Secondary|Plasma Pharmacokinetics - Elimination Half Life (t½)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Half-life is the time it takes for the concentration of drug to decline by 50%."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.||Hours||Standard Deviation|Mean
33905|NCT01537666|Primary|Safety and Tolerability - Number of Participants With Treatment Emergent Adverse Events (TEAEs = Adverse Events That Started During or After the First Dose of Study Drug)|Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: “How do you feel?” or “Have you had any (other) medical problems since your last visit/assessment?” Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable.|Healthy volunteers = 2 weeks; CF Patients = 1 week|All 18 healthy volunteers who received single doses of AeroVanc, 6 of which also received a single dose of IV vancomycin. All 7 Cystic Fibrosis patients who received at least one single dose of AeroVanc.||participants|||Number
33906|NCT01537432|Secondary|Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52|"Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient’s lesional skin biopsy was scored for the degree of histological improvement compared to that patient’s baseline disease on a five point scale; -~1 (worse) to +3 (excellent). Histological disease reversal or “excellent improvement” (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Week 52|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.||percentage of participants|||Number
33907|NCT01537432|Primary|Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12|"Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient’s lesional skin biopsy was scored for the degree of histological improvement compared to that patient’s baseline disease on a five point scale; -~1 (worse) to +3 (excellent). Histological disease reversal or “excellent improvement” (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Baseline, Week 12|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.||percentage of participants|||Number
33908|NCT01537367|Primary|The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure).|Primary care visits are scheduled appointments for HIV-positive patients to see a physician, nurse practitioner, or physician assistant (a provider who can prescribe medication) at the HIV clinic.|12 months after enrollment|Intention to Treat (ITT)||Percentage of Pt kept visits/#scheduled|||Number
33909|NCT01537367|Secondary|Mean Counts Per Person (Rates) of Kept Visits.|The rate of kept clinic visits per person over 12 months.|12 months after enrollment|||# kept visits/person/12 months||Standard Error|Mean
33910|NCT01537367|Primary|The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)|Kept visits for each patient were assessed in 4-month periods over the 12 months of the intervention. This is a binary measure, requiring attendance at least once in each of the three 4-month periods.|12 months after enrollment|Intention to Treat (ITT)||percent in care each 4 month period|||Number
33911|NCT01537315|Primary|Change From Baseline in Inflammatory Marker, Hs-C Reactive Protein, at 6 Months|Hs-CRP will be measured at baseline (before study drug) and at end of study (6 months). This marker is measured by ELISA assay from serum.|Baseline and 6 months|||ng/ml||Standard Deviation|Mean
33912|NCT01537302|Secondary|Contrast/Flush Volumes|Evaluation of the contrast/flush volumes.|Day 0||||||
33913|NCT01537302|Secondary|Use of Assist Devices|Evaluation of the use of assist devices.|Day 0||||||
33914|NCT01537302|Secondary|Crossing Times|Evaluation of crossing times.|Day 0||||||
33915|NCT01537302|Secondary|Fluoroscopic Times|Evaluation of fluoroscopic times.|Day 0||||||
33916|NCT01537302|Secondary|Procedural Times|Evaluation of procedural times.|Day 0||||||
33917|NCT01537302|Secondary|Device Performance|Device performance as assessed by Investigator’s input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO.|Day 0||||||
33918|NCT01537302|Secondary|Technical Success|Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.|Day 0|201 Enrolled||participants|||Number
33919|NCT01537302|Secondary|Procedural Success|Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.|Day 0|201 Enrolled||participants|||Number
33920|NCT01537302|Primary|Primary Efficacy Endpoint|Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.|Day 0|201 Enrolled||participants|||Number
33921|NCT01537302|Primary|Primary Safety Endpoint|No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.|Day 30|201 Enrolled, 2 Not Completed, 199 Analyzed||participants|||Number
33922|NCT01537198|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)|An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.|From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis|||participants|||Number
33923|NCT01537185|Secondary|Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG|• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.|28, 56 and 84 days following initial vaccination|only subjects with both baseline and day 84 samples were included in the analysis.||participants|||Number
33924|NCT01537185|Primary|Unsolicited Adverse Event Reports|"Safety and Tolerability assessed by cohort and product received measured by:~•Number of unsolicited AEs within four weeks after each vaccination"|within 1 week (0-7 days) following each vaccinations|||participants|||Number
33925|NCT01537133|Primary|Microbial Community Evenness|Pielou’s evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.||Pielou’s evenness index||Inter-Quartile Range|Median
33926|NCT01537133|Primary|Microbial Community Diversity|The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = −Σ p_i log(p_i).|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.||Shannon Diversity Index||Inter-Quartile Range|Median
34037|NCT01536405|Secondary|Percentage of Participants With Rubella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
33927|NCT01537133|Primary|Microbial Community Richness|Richness is the total number of different bacterial taxa detected in the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.||number of bacterial taxa||Inter-Quartile Range|Median
33928|NCT01537120|Secondary|HbA1C At 12 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.||HbA1c (%)||Standard Deviation|Mean
33929|NCT01537120|Secondary|Hemoglobin A1C (HbA1C) At 2 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.||HbA1c (%)||Standard Deviation|Mean
33930|NCT01537120|Primary|24 Hour Weighted Mean Glucose (WMG) At 2 Weeks|The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.||mg/dL||Geometric Coefficient of Variation|Geometric Mean
33931|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 5|Modified Intent-to-Treat(i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 5 are included.||units on a scale||Standard Deviation|Mean
33932|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 4|Modified Intent-To-Treat (i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 4 are included.||units on a scale||Standard Deviation|Mean
33933|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33934|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33935|NCT01537042|Secondary|Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period|"The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL).~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||scores on a scale||Standard Deviation|Mean
33936|NCT01537042|Secondary|Change From Baseline in Sleep Efficiency to the End of the Maintenance Period|"Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep.~A postive value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||sleep time/ total time in bed||Standard Deviation|Mean
33937|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period|"The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||movement per hour||Standard Deviation|Mean
33938|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33939|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33940|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33941|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33942|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33943|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33944|NCT01537042|Secondary|Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score|The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill).|Visit 2 (Baseline); Visit 6 (End of Maintence Period)|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||participants|||Number
33945|NCT01537042|Secondary|Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period|"The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated.~A negative value in Change from Baseline indicates an improvement from Baseline in IRLS."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||units on a scale||Standard Deviation|Mean
33946|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period.|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||movement/ hour||Standard Deviation|Mean
33947|NCT01537042|Primary|Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)|"The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG).~The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline].~A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.||ratio||95% Confidence Interval|Least Squares Mean
33948|NCT01536938|Primary|Subjects With ‘Controlled Disease’ (‘Clear’/‘Almost Clear’ for Subjects w. at Least Moderate Disease at Baseline, ‘Clear’ for Subjects With Mild Disease at Baseline) According to the Investigator’s Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks|||participants|||Number
33949|NCT01536886|Primary|Subjects With ‘Controlled Disease’ (‘Clear’/‘Almost Clear’ for Subjects w. at Least Moderate Disease at Baseline, ‘Clear’ for Subjects With Mild Disease at Baseline) According to the Investigator’s Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks|||participants|||Number
33950|NCT01536860|Primary|Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products|The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.|0-120 minutes|||mmol*min/L||Standard Error|Mean
33951|NCT01536704|Secondary|Elimination Rate Constant for Plasma Nicotine: K (el)|Kel was calculated with the help of plasma time concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||1/hr||Full Range|Median
33952|NCT01536704|Secondary|Apparent Elimination Half-life of Nicotine T(1/2)|T(1/2) was calculated using plasma time-concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||hr||Full Range|Median
33953|NCT01536704|Secondary|Time to Reach Maximum Plasma Nicotine Concentration (Tmax)|Tmax was time at which Cmax of nicotine was reached.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||hr||Full Range|Median
33954|NCT01536704|Secondary|AUC [0-infinity (Inf)]|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||ng.hr/mL||Standard Deviation|Mean
33955|NCT01536704|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)]|Cmax was depicted from plasma concentration of nicotine.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||ng/mL||Standard Deviation|Mean
33956|NCT01536704|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]|AUC(0-t) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.||nanogram (ng).hour (hr)/millilitre (mL)||Standard Deviation|Mean
33957|NCT01536587|Secondary|Arterial Stiffness at Baseline (Week 0) and at Week 4|Arterial stiffness occurs as a consequence of age and arteriosclerosis. Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. PWV was evaluated in terms of meters per second (m/s). PWV after salmeterol inhalation at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after inhalation of salmeterol) was assessed.|Baseline and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||m/s||Standard Deviation|Mean
33958|NCT01536587|Secondary|Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4|Diastolic dysfunction refers to the decline in performance of one (usually the left ventricle) or both (left and right) ventricles during diastole. The number of participants with diastolic dysfunction on echocardiography was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
33959|NCT01536587|Secondary|Lung Function (Forced Vital Capacity [FVC], Functional Residual Capacity [FRC; Body and Helium], Total Lung Capacity [TLC], and Residual Volume [RV]) at Baseline (Week 0) and at Week 4|FVC is defined as the volume of air that can be forcibly blown out from the lungs after a full inspiration. FRC is defined as the volume of air present in the lungs, specifically the parenchyma tissues, at the end of a passive expiration. TLC is defined as the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to VC plus the RV and is approximately 5800 milliliters. RV is defined as the amount of gas remaining in the lungs at the end of a maximal exhalation. All parameters describing lung function are expressed in terms of liters (L). Lung function (FVC, FRC [body and helium], TLC, and RV) was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||L||Standard Deviation|Mean
33960|NCT01536587|Secondary|Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4|Transcutaneous carbon dioxide monitoring is a noninvasive way of continuously measuring the tension of these gases in the skin. This methodology provides a continuous noninvasive estimation of the arterial CO2 value. Change in tCO2 after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population. Only those participants available at the indicated time points were assessed.||mmHg||Standard Deviation|Mean
33961|NCT01536587|Secondary|Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. Change in SpO2 after salmeterol inhalation is expressed in terms of percent. Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population: all participants included in the study who received at least one dose of study medication. Only those participants available at the indicated time points were assessed.||percent||Standard Deviation|Mean
33962|NCT01536587|Secondary|Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (BNP) after salmeterol inhalation is expressed in terms of picograms per milliliter (pg/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||pg/mL||Standard Deviation|Mean
33963|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma epinephrine) after salmeterol inhalation is expressed in terms of nanograms per milliliter (ng/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ng/mL||Standard Deviation|Mean
33964|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma norepinephrine) after salmeterol inhalation is expressed in terms of nanogramms per liter (ng/L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ng/L||Standard Deviation|Mean
33965|NCT01536587|Secondary|Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4|Respiratory minute volume is defined as the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. Change in respiratory minute volume after salmeterol inhalation is expressed in terms of milliliters per minute (mL/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||mL/min||Standard Deviation|Mean
34038|NCT01536405|Secondary|Percentage of Participants With Measles-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
33966|NCT01536587|Secondary|Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4|Tidal volume is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 milliliters or 7 milliliters per kilogram of body weight). Change in tidal volume after salmeterol inhalation is expressed in terms of milliliters (mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||mL||Standard Deviation|Mean
33967|NCT01536587|Secondary|Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4|Respiratory rate is defined as the number of breaths taken within a set amount of time (typically within 60 seconds). Change in respiratory rate after salmeterol inhalation is expressed in terms of respiratory rate (breaths) per minute (min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||breaths per minute||Standard Deviation|Mean
33968|NCT01536587|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4|Systolic and diastolic BP was manually measured. Change in BP after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||mmHg||Standard Deviation|Mean
33969|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||L||Standard Deviation|Mean
33970|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||L||Standard Deviation|Mean
33971|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||ms/mmHg||Standard Deviation|Mean
33972|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ms/mmHg||Standard Deviation|Mean
33973|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||beats per minute (bpm)||Standard Deviation|Mean
33974|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||beats per minute (bpm)||Standard Deviation|Mean
34039|NCT01536405|Secondary|Percentage of Participants With Mumps-like Symptoms||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
33975|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency Power (HF) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||percent change||Standard Deviation|Mean
33976|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||percent change||Standard Deviation|Mean
33977|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||percent change||Standard Deviation|Mean
33978|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||percent change||Standard Deviation|Mean
33979|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms^2||Standard Deviation|Mean
33980|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms^2||Standard Deviation|Mean
33981|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (N-N) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation), respectively.|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms^2||Standard Deviation|Mean
34040|NCT01536405|Secondary|Percentage of Participants With Zoster-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
34041|NCT01536405|Secondary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
33982|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline were calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms^2||Standard Deviation|Mean
33983|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms||Standard Deviation|Mean
33984|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms||Standard Deviation|Mean
33985|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population||ms||Standard Deviation|Mean
33986|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate variability (HRV) refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.||ms||Standard Deviation|Mean
33987|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per minute (bursts/minute). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||Bursts/minute||Standard Deviation|Mean
33988|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per minute [bursts/minute]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population||Bursts/minute||Standard Deviation|Mean
33989|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per 100 heart beats (bursts/100 heart beats). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.||Bursts/100 heart beats||Standard Deviation|Mean
34042|NCT01536405|Primary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 5 days after vaccination 1|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
33990|NCT01536587|Primary|Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats [bursts/100 heart beats]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population: all participants who received at least one dose of study medication and who had a valid data registration period of the primary endpoint.||Bursts/100 heart beats||Standard Deviation|Mean
33991|NCT01536574|Secondary|Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||Scores on a scale||Standard Deviation|Mean
33992|NCT01536574|Secondary|Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe.|Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.||Scores on a scale||Standard Deviation|Mean
33993|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population||Participants|||Number
33994|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population||Participants|||Number
33995|NCT01536574|Primary|Number of Participants With an Adverse Event During the Follow-up Phase|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population||Participants|||Number
33996|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.|From the start of treatment (Baseline) up to Week 25|Safety Population||Participants|||Number
33997|NCT01536574|Primary|Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|From the start of treatment (Baseline) up to Week 25|Safety Population: all participants who received at least one dose of study drug||Participants|||Number
33998|NCT01536561|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||G/dL||Full Range|Median
34043|NCT01536405|Primary|Geometric Mean Titer (GMT) of Rubella Virus Antibodies|Sera were tested for rubella virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results||IU/mL||95% Confidence Interval|Geometric Mean
34179|NCT01535235|Primary|Change in HIV RNA (Copies/Million Rectal Cells)|Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.||copies/million rectal cells||Inter-Quartile Range|Median
33999|NCT01536561|Secondary|Nadir Values for the Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.||1000 cells/millimeters cubed (mm^3)||Full Range|Median
34000|NCT01536561|Secondary|Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters|Time to recovery to baseline is the time required for recovery from nadir values to baseline values.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.||days||95% Confidence Interval|Median
34001|NCT01536561|Secondary|Time to Nadir for the Indicated Hematologic Laboratory Parameters|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.||days||Full Range|Median
34002|NCT01536561|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||participants|||Number
34003|NCT01536561|Secondary|Time to HAMA Positivity From the First Dosimetric Dose (Time From Baseline [Dosimetric Dose] to the First Reported Presence of HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.||days||Full Range|Median
34004|NCT01536561|Secondary|Number of Participants Who Developed Human Anti-mouse Antibodies (HAMA Postivitiy) After Receiving Tositumomab|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.||participants|||Number
34005|NCT01536561|Secondary|Volume of Distribution at Steady State (Vss) of I 131 TST for the Indicated Antibody Predose Levels|Vss is defined as the volume of distribution of the drug at steady state.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||liters|Participants|Standard Deviation|Mean
34006|NCT01536561|Secondary|Maximum Blood Concentration (Cmax) of I 131 TST for the Indicated Antibody Predose Levels|Cmax is defined as the maximum observed concentration of the drug in blood.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||% Injected Dose per milliliter (%ID/mL)|Participants|Standard Deviation|Mean
34007|NCT01536561|Secondary|Area Under the Concentration Time Curve (AUC) of I 131 TST for the Indicated Antibody Predose Levels|Area under the concentration-time curve from the end of the infusion extrapolated to infinite time. AUC measures how much drug is in the system over time after infusion. ID, injected dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||%ID * hours per milliliter (%ID.hr/mL)|Participants|Standard Deviation|Mean
34008|NCT01536561|Secondary|Clearance (CL) of I 131 TST for the Indicated Antibody Predose Levels|Clearance is defined as the volume of blood from which drug is removed per unit time and is a measure of the rate at which drug is removed from the body after the dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||Milliliters per hour (mL/hr)|Participants|Standard Deviation|Mean
34009|NCT01536561|Secondary|Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model . t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model; also denoted as t1/2. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.||hours (hr)|Participants|Standard Deviation|Mean
34010|NCT01536561|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
34011|NCT01536561|Secondary|Time to Progression of Disease or Death|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who experienced progression were evaluated.||months||95% Confidence Interval|Median
34012|NCT01536561|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants with unconfirmed response (CR, CCR, or PR) and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
34013|NCT01536561|Secondary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
34014|NCT01536561|Secondary|Number of Participants (Par.) With the Indicated Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
34015|NCT01536561|Secondary|Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)|The effect of unlabeled TST pre-treatment on targeting of radioactive TST was evaluated. Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose (DD) and then daily for at least 5 days. Initially, participants received either two or three DDs, each of which was preceded by a pre-dose of unlabeled tositumomab (0, 95, or 475 mg) to determine the dose of unlabeled tositumomab that optimized the radiation dose to tumor. The tumor radiation absorbed dose was determined using gamma camera images.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Participants who received unlabelled doses of 0 mg, 95 mg, or 475 mg were analyzed. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ."||cGy/75 cGy TBD|Participants|Standard Deviation|Mean
34016|NCT01536561|Primary|Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)|Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose and then daily for at least 5 days. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). Spleen volume may vary based on disease status, and volume correction allows for a comparison of spleen dose across participants.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ depending on whether adequate gamma camera images were available for analysis after each of the 86 DD."||cGy/75 cGy TBD|Participants|Standard Deviation|Mean
34044|NCT01536405|Primary|Geometric Mean Titer (GMT) of Mumps Virus Antibodies|Sera were tested for mumps virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results||Mumps Ab units/mL||95% Confidence Interval|Geometric Mean
34180|NCT01535222|Primary|Incidence of Serious Adverse Events|Number of patients experiencing Serious Adverse Events|7 days (day of surgery to day 7)|||participants|||Number
34017|NCT01536561|Primary|Maximum Tolerated Dose (MTD) of TST/I 131 TST Evaluated in the Study|Participants who had prior bone marrow transplantation (BMT) initiated TD at 65 cGy TBD, whereas those who had no prior BMT initiated TD at 25 cGy TBD. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||Total body radiation dose in cGy|||Number
34018|NCT01536561|Primary|Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)|Retreatment was administered to participants either at the initial TD of TST/I 131 TST or at a reduced dose if a >=Grade 2 toxicity had occurred after initial treatment, until the MTD was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 participants experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no participants were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population||participants|||Number
34019|NCT01536561|Primary|Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)|Par. (groups of 3-6) received the TD at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (par. who had bone marrow transplantation), increasing by 10 cGy increments at each dose level, until the maximum tolerated dose (MTD) was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced dose-limiting toxicity (DLT): any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug.||participants|||Number
34020|NCT01536496|Secondary|Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.|Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.|Up to 30 days post-injury.|||participants|||Number
34021|NCT01536496|Secondary|Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.||28 days.|||days||Inter-Quartile Range|Median
34022|NCT01536496|Secondary|Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury|Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.|24 hours post-injury|||units||Inter-Quartile Range|Median
34023|NCT01536496|Secondary|Change in r-TEG LY30 Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||percent of clot lysis at 30 min.||Inter-Quartile Range|Median
34024|NCT01536496|Secondary|Change in r-TEG Maximal Amplitude (MA) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||mm||Inter-Quartile Range|Median
34025|NCT01536496|Secondary|Change in r-TEG Angle Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||degrees||Inter-Quartile Range|Median
34026|NCT01536496|Secondary|Change in r-TEG ACT (Activated Clotting Time) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||seconds||Inter-Quartile Range|Median
34027|NCT01536496|Secondary|Change in D-dimer Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||ug/mL||Inter-Quartile Range|Median
34028|NCT01536496|Secondary|Change in Platelet Count Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||k/uL||Inter-Quartile Range|Median
34029|NCT01536496|Secondary|Change in Fibrinogen Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.|||mg/dL||Inter-Quartile Range|Median
34030|NCT01536496|Secondary|Change in INR Test Results.|A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|Within first 6 hours post-injury, 12 and 24 hours post-injury.|||units on a scale||Inter-Quartile Range|Median
34031|NCT01536496|Secondary|Time to Death From Injury in Hours.||From time of injury to 28th day of hospitalization.|||hours||Inter-Quartile Range|Median
34032|NCT01536496|Secondary|Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).||Up to 28 days post-injury.|||deaths|||Number
34033|NCT01536496|Secondary|Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).||Within 24 hours post-injury.|||deaths|||Number
34034|NCT01536496|Primary|28 Day In-hospital Mortality||28 days in hospital|||participants|||Number
34035|NCT01536405|Secondary|Percentage of Participants With an Injection-site Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.|Up to 5 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
34036|NCT01536405|Secondary|Percentage of Participants With Varicella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data||Percentage of participants|||Number
34181|NCT01535222|Primary|Incidence of Adverse Events|Number of patients experiencing Adverse Events|7 days (day of surgery to day 7)|||participants|||Number
34045|NCT01536405|Primary|Geometric Mean Titer (GMT) of Measles Virus Antibodies|Sera were tested for measles virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results||mIU/mL||95% Confidence Interval|Geometric Mean
34046|NCT01536405|Primary|Geometric Mean Titer (GMT) of VZV Antibodies|Sera were tested for VZV IgG antibody levels by gpELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results||ELISA units/mL||95% Confidence Interval|Geometric Mean
34047|NCT01536405|Primary|Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)|Sera were tested for rubella virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results||Percentage of participants||95% Confidence Interval|Number
34048|NCT01536405|Primary|Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL|Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results||Percentage of participants||95% Confidence Interval|Number
34049|NCT01536405|Primary|Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL|Sera were tested for measles virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results||Percentage of participants||95% Confidence Interval|Number
34050|NCT01536405|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL|Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results||Percentage of participants||95% Confidence Interval|Number
34051|NCT01536366|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||ng.h/mL||Standard Deviation|Mean
34052|NCT01536366|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||ng.h/mL||Standard Deviation|Mean
34053|NCT01536366|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||hours||Full Range|Median
34054|NCT01536366|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.|||ng/mL||Standard Deviation|Mean
34055|NCT01536262|Secondary|Trough FEV1 Response|"Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.~Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose after 52 weeks|Full analysis set (FAS)||L||Standard Error|Mean
34056|NCT01536262|Secondary|FEV1 AUC0-3h Response|"Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.~Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks|Full analysis set (FAS): This patient set included all randomised patients who received at least 1 dose of treatment and had both non-missing baseline and at least 1 non-missing post-baseline efficacy measurement. Assignment to FAS was done after implementation of any data handling rules which set measurements to missing.||L||Standard Error|Mean
34057|NCT01536262|Primary|Number (%) of Patients With Drug-related AEs|Number (%) of patients with drug-related Adverse Events (AEs).|From first drug administration until 21 days after the last administration, upto 392 days|Treated set: This patient set included all patients who received at least 1 dose of treatment.||percentage of participants|||Number
34058|NCT01536197|Secondary|Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).|-Eating behavior will be measured with validated questionnaires including among others the Dutch Eating Behavior Questionnaire (DEBQ) and the Food Craving Inventory (FCI). The DEBQ measures three common psychological dimensions of eating behavior: 1) emotional eating , 2) external eating (an inclination to eat in response to external food cues such as the smell and taste of food), and 3) restrained eating (an inclination to consciously restrict food intake to control body weight). The FCI is a validated measure of the frequency of overall food cravings as well as cravings for specific types of foods (high fats, sweets, carbohydrates/ starches, and fast-food fats) during the past month. For the DEBQ and the FCI, subjects score their answers by using a 5-point Likert scale (1=never, 5=very often/always).Therefore, lower numbers means having less frequent food cravings (for FCI), or engaging less frequently in the particular type of eating behavior (for DEBQ).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery|||units on a scale||Standard Deviation|Mean
34059|NCT01536197|Primary|Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).|-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery|||mmol/L||Inter-Quartile Range|Median
34070|NCT01536145|Secondary|Pharmacodynamic-based Dose|The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression|Cycle 1 (Week 4 or Week 8)|Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.|||||
34060|NCT01536184|Secondary|The Strengths and Difficulties Questionnaire SDQ|The Emotional Symptoms (SDQ-ES), Conduct Problems (SDQ-CP), Hyperactivity (SDQ-HA), Peer Problems (SDQ-PP), and Prosocial (SDQ-PS) Scales each range from 0-10 Higher values in (ES, CP, HA, and PP) indicate a greater degree of abnormal behavior; low values indicate more normative behavior. For the PS scale, higher values indicate greater strengths in prosocial behaviour and lower values indicate more difficulties with prosocial behavior. A Total Difficulties Score ranges from 0 to 40 with higher scores reflecting higher levels of behavioral difficulty. The Total Impact Supplement Score (Total IS) ranges from 0 to 10 with higher values indicating greater behavioral difficulty and social impairment.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Please see category specific n values below.||units on a scale||Full Range|Mean
34061|NCT01536184|Secondary|The Depression Anxiety Stress Scale (DASS)|"A self-report measure of depression, anxiety, and stress. The scales of the DASS show high internal consistency and produce meaningful discriminations in different settings, and are appropriate for measuring the emotional states of caregivers over time.~The score for each item ranges from 0 to 3, where 0 indicates did not apply to me at all and 3 indicates applied to me very much, or most of the time. The individual items are combined using a scoring template into measures of Depression (D), Anxiety (A), and Stress (S). Depression is scored out of 28 where 0-9 is normal and 10-28 reflect mild, moderate, and severe degrees of depression. Anxiety is scored out of 20 where 0-7 is normal and 8-20 reflect mild, moderate, and severe degrees of anxiety. Stress is scored out of 34 where 0-14 is normal and 15-34 reflect mild, moderate, and severe degrees of stress."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2||units on a scale||Full Range|Mean
34062|NCT01536184|Secondary|The Parenting Stress Index (PSI)|"A parent-report questionnaire of parental stress reflecting parent-child interaction style and difficult child behaviour. There are two main domain scores, a Child Domain Score and Parent Domain Score from which a Total Stress Score is calculated.~Child and Parent Domain raw scores combine to form a Total Stress raw score. Higher scores for each item indicate a higher degree of negative attributes in the given scale while lower scores indicate lower relationship stress and a greater sense of enjoyment in the relationship.~Items include:~Defensive Responding (DR) Score range 7-35 Parental Distress (PD) Score range 12-60 Parent-Child Dysfunctional Interaction (PCDI) Score range 12-60 Difficult Child (DC) Score range 12-60 PSI Total Stress Score range 36-180"|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|||units on a scale||Full Range|Mean
34063|NCT01536184|Secondary|The Parenting Scale (TPS)|"A self-report measure of dysfunctional parenting practices including laxness, over-reactivity, and verbosity. The scale has good internal consistency and test-restest reliability and scores are consistent with other measures of dysfunctional discipline and child misbehaviour.~Each subscale score, ranges from 1 to 7; for each subscale (Laxness, Overreactivity, Verbosity) lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours. The total score is calculated from a combination of each subscale and also ranges from 1 to 7, reflecting the degree of ineffective parenting behaviours across all categories with lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of Participants Analyzed Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2||units on a scale||Full Range|Mean
34064|NCT01536184|Primary|Attachment Classification|Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of participants analyzed Receives COS Intervention Pretest= 8; Post-test=3; Follow-up=4 Control Group Pretest=4; Post-test=1; Follow-up=1||participants|||Number
34065|NCT01536171|Primary|Metabolic Rate During Barefoot and Shod Running|"This study will measure the metabolic rate when a person runs on the treadmill with shoes (shod) and without shoes.~Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit|||kilojoules per minute||Standard Deviation|Mean
34066|NCT01536171|Secondary|Peak Impact Forces During Barefoot and Shod Running|"This study will be measuring the peak impact forces that a runner produces when running on the treadmill with shoes (shod) and without shoes.~Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit|||Newtons||Standard Deviation|Mean
34067|NCT01536145|Secondary|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease [PD])|Baseline up to end of treatment|A substantial number of participants were not followed-up prior to disease progression, therefore time to disease progression was not estimated.|||||
34068|NCT01536145|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).|Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)|All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.||percentage of participants|||Number
34069|NCT01536145|Secondary|Human Anti-human Antibody (HAHA) Response to CP-751,871||30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg|All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.|||||Number
43424|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
34073|NCT01536145|Secondary|Single Dose Systemic Clearance (CL) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
34074|NCT01536145|Secondary|Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||mL/kg||Standard Deviation|Mean
34075|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||mg•hr/L||Standard Deviation|Mean
34076|NCT01536145|Secondary|Single Dose Plasma Decay Half-life (t1/2) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||days||Standard Deviation|Mean
34077|NCT01536145|Secondary|Single Dose Volume of Distribution (Vz) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.||milliliter/kilogram (mL/kg )||Standard Deviation|Mean
34078|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.||milligram•hour/liter (mg•hr/L)||Standard Deviation|Mean
34079|NCT01536145|Secondary|Single Dose End-of-infusion Concentration (Cinf) for CP-751,871||1 hour postdose in Cycle 1|All participants treated who had at least 1 concentration.||milligram/liter (mg/L)||Standard Deviation|Mean
34080|NCT01536145|Primary|Maximum Tolerated Dose (MTD)|The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants|Baseline up to Cycle 1 (Week 4 or Week 8)|All participants who received at least 1 dose of study drug CP-751,871.||mg/kg|||Number
34081|NCT01536119|Secondary|Paternal Infant Feeding Attitude|Paternal infant feeding attitude will be assessed using the Iowa Infant Feeding Attitude Scale. This scale consist of 17 items with a five point response range (1-5). The total scores range from 17-85. Negative items were reverse scored. Lower scores indicate a preference for formula feeding, while higher scores indicating a preference for breastfeeding.|6 weeks postpartum|Analysis population included only fathers who completed the scale at 6 weeks postpartum||units on a scale||Standard Deviation|Mean
34082|NCT01536119|Secondary|Paternal Breastfeeding Self-Efficacy|"Breastfeeding Self-Efficacy Scale- Short Form will be adapted and used to assess fathers' confidence with assisting their partner with breastfeeding.~This instrument has 14 items, with responses ranging from 1-5. The total scores range from 14-70 with higher scores indicating higher breastfeeding self-efficacy."|6 weeks postpartum|Analysis population included fathers completed the scale and who had infants breastfeeding at 6 weeks postpartum (fathers of infants fed expressed breastmilk were not included).||units on a scale||Standard Deviation|Mean
34083|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|12 weeks|Analysis population included only mothers who completed the scale at 12 weeks postpartum||units on a scale||Standard Deviation|Mean
34084|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|6 weeks|Analysis population included only mothers who completed the scale at 6 weeks postpartum.||units on a scale||Standard Deviation|Mean
34085|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS). There are 35 items in total in this tool. There is a 7 point response scale ranging from 0 to 6. Total scores range from 0 - 210. Negative items are reversed. Higher scores indicated positive coparenting.|12 weeks postpartum|Analysis population included only mothers who completed the scale at 12 weeks postpartum.||units on a scale||Standard Deviation|Mean
34086|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS) Brief Form. There are 14 items in total in this tool. There is a 7 point response scale ranging from 0 - 6. The total score ranges from 0 - 84. Negative items are reversed and the higher scores indicate positive coparenting.|6 weeks|Analysis population included only mothers who completed the questionnaire at 6 weeks postpartum.||units on a scale||Standard Deviation|Mean
34087|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|12 weeks|Analysis population included only mothers||participants|||Number
34088|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|6 weeks|Analysis population included only mothers||participants|||Number
34089|NCT01536119|Secondary|Exclusive Breastfeeding|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|6 weeks|Analysis population included only mothers||percentage of participants|||Number
34090|NCT01536119|Primary|Exclusive Breastfeeding Rate at 12 Weeks Postpartum|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|12 weeks postpartum|Analysis population included only mothers||percentage of participants|||Number
34091|NCT01536093|Secondary|Development of Adverse Effects|"category of adverse effects~general - fever or hypothermia, rash~respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia~gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis~renal - oliguria (urine output < 1.0cc/kg/day)~laboratory - hypo-/hyper-natremia, acidosis, hypercarbia"|from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age||||||
34092|NCT01536093|Secondary|In-hospital Death||up to 4 months of age||||||
34093|NCT01536093|Secondary|Development of Intraventricular Hemorrhage ≥ Grade 3||up to 4 months of age||||||
34094|NCT01536093|Secondary|Development of Bronchopulmonary Dysplasia ≥ Moderate||up to 4 months of age||||||
34095|NCT01536093|Secondary|Episodes of Pneumonia|numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics|from date of randomization up to 4 months of age||||||
34096|NCT01536093|Secondary|Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2||from date of randomization up to 4 months of age||||||
34097|NCT01536093|Secondary|Episodes of Culture Positive Sepsis|numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)|from date of randomization up to 4 months of age||||||
34098|NCT01536093|Secondary|Total Hospital Admission Duration|days from admission to discharge from NICU|up to 4 months of age||||||
34099|NCT01536093|Secondary|Time to Reach Full Feeding|day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day|up to 2 months of age||||||
34100|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||2 weeks of age||||||
34101|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||1 week of age||||||
34102|NCT01536093|Secondary|Concentration of Urinary IL-1 Beta||2 weeks of age|||ug per g creatinine||Standard Deviation|Mean
34103|NCT01536093|Secondary|Concentration of Urinary Lactoferrin||1 week of age|||ug per g creatinine||Standard Deviation|Mean
34104|NCT01536093|Secondary|Salivary IL-8 Concentration at 2 Weeks of Age||2 weeks of age|||ng/mL||Standard Deviation|Mean
34105|NCT01536093|Secondary|Salivary TGF-beta 1 Concentration at 2 Week of Age||2 week of age|||ug/mL||Standard Deviation|Mean
34106|NCT01536093|Secondary|Urinary Secretary IgA Concentration at 1 Week of Age||1 week of age|||ng per g creatinine||Standard Deviation|Mean
34107|NCT01536093|Primary|Urinary Secretary IgA Concentration at 2 Weeks of Age||2 weeks of age|||ng per g creatinine||Standard Deviation|Mean
34108|NCT01536067|Secondary|Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0|Maximum grade per participant of any AE.|Every 30 days for 2 months|All treated and eligible patients||participants|||Number
34109|NCT01536067|Secondary|Duration of Response||From the observation of a response to the time of disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
34110|NCT01536067|Secondary|Progression-free Survival||From start of treatment to disease progression or death (regardless of the cause of death), whichever comes first, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
34111|NCT01536067|Secondary|Time to Progression||From start of treatment to disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
34112|NCT01536067|Secondary|Frequency of PR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
34113|NCT01536067|Secondary|Frequency of Very Good Partial Response (VGPR)||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
34114|NCT01536067|Secondary|Frequency of Near (n)CR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
34115|NCT01536067|Secondary|Frequency of Complete Remission (CR)||Every 28 days||||||
34116|NCT01536067|Primary|Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib|Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.|Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
34117|NCT01536015|Secondary|Change in Score on Parkinson’s Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period|The Parkinson’s Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
34118|NCT01536015|Secondary|Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period|"The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree)."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
34119|NCT01536015|Secondary|Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period|Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
34120|NCT01536015|Secondary|"Change in Predictability of Off Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
34121|NCT01536015|Secondary|"Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the on State From Baseline to the End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
34122|NCT01536015|Primary|"Change in Rotigotine Versus Placebo in the Absolute Time Spent Off From Baseline to the End of the 7-week Maintenance Period"|"Mean number of hours marked off during a 24-hour period."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.|||||
34123|NCT01535976|Primary|Intraoperative Hypoventilation|Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.|8 hours|The median percentage of the sedation time with TCO2 > 50 mmHg||% time||95% Confidence Interval|Median
34124|NCT01535807|Secondary|Post Operative Atrial Fibrillation|Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.|Within 30 days||||||
34125|NCT01535807|Primary|Inflammatory Biomarkers|"The identification of global low molecular weight (LMW) serum proteomic changes associated with CorMatrix ECM treated patients.~Identification of porcine specific LMW and phosphoproteomic serum protein changes associated with CorMatrix ECM treated patients."|Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3.|||participants|||Number
34126|NCT01535729|Secondary|Median Overall Survival: Best Response to Prior Chemotherapy|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the CRF, hence, the analysis could not be performed.|||||
34127|NCT01535729|Secondary|Median Overall Survival: Smoking Status|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34128|NCT01535729|Secondary|Median Overall Survival: Gender|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34129|NCT01535729|Secondary|Median Overall Survival: Overall|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34130|NCT01535729|Secondary|Median Progression Free Survival: Best Response to Prior Chemotherapy|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the Case Report Form (CRF), hence, the analysis could not be performed.|||||
34182|NCT01535118|Secondary|Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma|Participants were asked about co-morbid health conditions. The percentage of participants who had received allergy shots to treat ARC and had asthma was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey and received allergy shots.||percentage of participants|||Number
34131|NCT01535729|Secondary|Median Progression Free Survival: Smoking Status|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34132|NCT01535729|Secondary|Median Progression Free Survival: Gender|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34133|NCT01535729|Secondary|Median Progression Free Survival: Age|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34134|NCT01535729|Secondary|Median Progression Free Survival: Overall|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression no death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34135|NCT01535729|Secondary|Percentage of Participants With Remission of CR and PR|Remission was defined as participants with CR or PR. CR: disappearance of all TLs and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34136|NCT01535729|Secondary|Time to Start of Erlotinib Therapy After End of First Line Therapy||Baseline|SAF with number of participants evaluable for this outcome measure.||months||Full Range|Median
34137|NCT01535729|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)|Response rate was observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST). It consisted of CR, PR, SD and progressive disease (PD). Participants with CR, PR and SD were reported. CR: disappearance of all target lesions (TLs) and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34138|NCT01535729|Secondary|Percentage of Participants With Dyspnea by Severity|Severity of dyspnea was categorized as mild, moderate, severe, life-threatening and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no dyspnea were not included.|Baseline, Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34139|NCT01535729|Secondary|Percentage of Participants With Cough by Severity|Severity of cough was categorized as mild, moderate, severe and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no cough were not included.|Baseline, Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34140|NCT01535729|Secondary|Percentage of Participants With Dose Withdrawals by Reason|Reasons for dose withdrawals included progression, participants' wish, intolerance, others and not known. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34141|NCT01535729|Secondary|Percentage of Participants With Dose Modifications by Reason|Dose modification included increase or decreased in the dose of the drug and interrupted dose. Reasons for dose modification included progression, participants' wish, intolerance and others. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34142|NCT01535729|Secondary|Percentage of Participants With Fatigue Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34143|NCT01535729|Secondary|Percentage of Participants With Diarrhea Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34144|NCT01535729|Secondary|Percentage of Participants With Rash Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34145|NCT01535729|Secondary|Percentage of Participants With Diarrhea||Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34146|NCT01535729|Secondary|Percentage of Participants With Rash||Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34147|NCT01535729|Secondary|Percentage of Participants With Fatigue||Months 3, 6, 9, 12|SAF||percentage of participants|||Number
34148|NCT01535729|Secondary|Median Overall Survival: Age|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF||months||95% Confidence Interval|Median
34149|NCT01535729|Primary|Percentage of Participants Who Were Alive 1 Year After Start of Treatment|Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.|Year 1|SAF||percentage of participants||95% Confidence Interval|Number
34150|NCT01535664|Primary|Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).~Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT*0.5) + (ZADT*0.2) + (ZLOS*0.3)~Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)||units on a scale||Standard Deviation|Mean
34151|NCT01535664|Secondary|Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS population~A higher walking speed is indicative of better performance"|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population||Feet per second (ft/s)||Standard Deviation|Mean
34152|NCT01535664|Secondary|Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch.~A larger walking distance is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population||Meters||Standard Deviation|Mean
34153|NCT01535664|Secondary|Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|The BBS is a 14-item scale that evaluates subjects ability to sit, stand, reach, maintain single-leg stance, and turn. The scoring is rated from 0 (cannot perform task) to 4 (normal performance of task) for each of 14 items. The maximum possible score is 56 and the lowest 0. A higher total score is indicative of better performance.|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population||units on a scale||Standard Deviation|Mean
34154|NCT01535664|Primary|Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).~ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway).~Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)||units on a scale||Standard Deviation|Mean
34155|NCT01535638|Primary|Cmax|Maximum measured concentration of Deleobuvir in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|1:00 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS).||nmol/L||Geometric Coefficient of Variation|Geometric Mean
35689|NCT01512745|Secondary|Disease Control Rate(DCR)|Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.|30 months|||percentage of participants|||Number
34156|NCT01535638|Primary|AUC0-∞|"Area under the concentration-time curve of Deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS) included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK and no vomiting must have occurred at or before two times the median tmax.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34157|NCT01535599|Secondary|Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary|Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.|Time to event, up to Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. Patients who did not report ear pain at any diary entry during first 7 days of the study were excluded from the analysis.||days||Standard Error|Median
34158|NCT01535599|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.||percentage of participants|||Number
34159|NCT01535599|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.||percentage of participants|||Number
34160|NCT01535560|Secondary|Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary|Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.|Time to event (Day 1 to Day 11)|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline, minus missing responses.||Days||Standard Error|Median
34161|NCT01535560|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.||Percentage of participants|||Number
34162|NCT01535560|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.||Percentage of participants|||Number
34163|NCT01535365|Secondary|Request for Rescue Analgesia|Number of participants requesting a rescue analgesic be given|30 minutes|||Participants|||Number
34164|NCT01535365|Primary|Pain Score After Treatment|Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable|30 minutes|this sample size gives 80% power to detect a size effect of one SD||mm||95% Confidence Interval|Mean
34165|NCT01535326|Other Pre-specified|Post-procedure Discomforts and 30 Day Complication Rate|telephone follow up for post-procedure discomforts and 30 day complication rate|one month||||||
34166|NCT01535326|Secondary|Number of Participants With at Least One Adenoma|the number of participants with at least one adenoma in each of the study groups.|9 to 12 months|||participants|||Number
34167|NCT01535326|Secondary|Patient Satisfaction Score|satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied|9 to 12 months|||units on a scale||Full Range|Median
34168|NCT01535326|Secondary|Patient Pain Score|The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)|9 to 12 months|||units on a scale||Full Range|Median
34169|NCT01535326|Primary|Proportion of Patients Without Pain|proportion of patients without insertion pain during colonoscopy|up to 12 months|||participants|||Number
34183|NCT01535118|Primary|Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication|Participants who received subcutaneous immunotherapy (allergy shots) were asked about prescription and over-the-counter medication use. The percentage of participants who received allergy shots to treat ARC, had not taken over-the-counter allergy medication and required supplemental prescription allergy medication for ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey, received immunotherapy (allergy shots) and had not taken over-the-counter allergy medication.||percentage of participants|||Number
35690|NCT01512745|Primary|Overall Survival(OS)|Overall Survival of the Participants|30 months|||month||95% Confidence Interval|Median
34170|NCT01535261|Secondary|Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value for both baseline and the post-baseline visit.||Score on a scale||Standard Deviation|Mean
34171|NCT01535261|Secondary|Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.||Microns||Standard Deviation|Mean
34172|NCT01535261|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.||Letters|||Number
34173|NCT01535261|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at month 12 as compared with baseline|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.||Letters|||Number
34174|NCT01535261|Secondary|Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy|Month 12 and Month 24|Full analysis set with use of LOCF consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value at treatment interruption and an average for the post treatment interruption visits.||Letters||Standard Deviation|Mean
34175|NCT01535261|Secondary|Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients.|Baseline and Month 1 to 12 or Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.||letters||Standard Deviation|Mean
34176|NCT01535261|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.||Letters||Standard Deviation|Mean
34177|NCT01535261|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.||Letters||Standard Deviation|Mean
34178|NCT01535235|Secondary|Change in HIV DNA (Copies/Million Rectal Cells)|Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.||copies/million rectal cells||Inter-Quartile Range|Median
34276|NCT01533597|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours||at week 24 relative to baseline|||episodes||95% Confidence Interval|Mean
34184|NCT01535118|Primary|Percentage of Participants Who Received Immunotherapy to Treat ARC|Participants who had ever received immunotherapy for ARC were asked about the type of immunotherapy - subcutaneous or sublingual - received. The percentage of participants who received immunotherapy to treat ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
34185|NCT01535118|Primary|Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months|Participants were asked about prescription and over-the-counter medication use for ARC. The percentages of participants who used prescription and/or over-the-counter medication to treat ARC in the past 12 months were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
34186|NCT01535118|Primary|Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months|Participants were asked about the impact of ARC on loss of work and school time. The percentage of participants who experienced work or school absence due to ARC in the prior 12 months was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
34187|NCT01535118|Primary|Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)|Participants were asked about the frequency and severity of ARC symptoms when allergies were at their worst. The percentages of participants who experienced different symptoms of ARC on a daily basis when allergies were at their worst were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.||percentage of participants|||Number
34188|NCT01535040|Secondary|Smoking Withdrawal|The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).|12 weeks|Participants who provided data at any time||units on a scale||Standard Error|Least Squares Mean
34189|NCT01535040|Secondary|Nicotine Dependence|The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.|12 weeks|Participants who reported any data||units on a scale||Standard Error|Least Squares Mean
34190|NCT01535040|Primary|Adherence|Adherence is the percentage of prescribed pills taken while on therapy.|12 weeks|Participants who returned pill diaries.||percentage of prescribed pills||Full Range|Mean
34191|NCT01535040|Primary|Retention|Retention is defined as the percentage of participants who complete the 12 week visit|12 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
34192|NCT01535001|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.~Number of sites with pain in the previous 24 hours shaded on a region-divided body chart~Pain location and type assessed using the Knee Pain Map.~Maximum isometric muscle strength measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander).~Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II) at five sites at the knee and the m. tibialis anterior muscle and the m. extensor carpi radialis longus.~Postural balance assessed using an instrumented force platform (Good Balance), measuring the centre of pressure excursion.~Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'."|Baseline, 3months, 6months, 12months and 24months|Since this is exploratory outcomes they will be analyzed in future publications.|||||
34193|NCT01535001|Secondary|Change From Baseline in Time From the Timed Up and Go||Primary: 12 months.|||sec||95% Confidence Interval|Mean
34194|NCT01535001|Secondary|Number of Serious Adverse Events Reported at Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants.|Primary: 12months.|||Serious adverse events related to knee|||Number
34195|NCT01535001|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.|||proportion of participants||95% Confidence Interval|Number
34196|NCT01535001|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in this analysis.||kg||95% Confidence Interval|Mean
34197|NCT01535001|Secondary|Change in the Five KOOS Subscale Scores From Baseline|Range of all subscales are 0 to 100 (worst to best).|Primary: 12 months.|||units on a scale||95% Confidence Interval|Number
34198|NCT01535001|Secondary|Change From Baseline in 20-meter Walk||Primary: 12months.|||sec||95% Confidence Interval|Mean
34199|NCT01535001|Secondary|Change From Baseline in EQ-5D|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See statistical analysis plan for further description (available under Links).~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
34200|NCT01535001|Primary|Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)|"The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best).~Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority."|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
34201|NCT01534962|Secondary|Number of Patients in Sinus Rhythm 48 Hours After Cardioversion With Documented AF Recurrence|Documented AF recurrences in those patients who did not experience early relapses (within 48 hours after cardioversion)|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion||participants|||Number
34202|NCT01534962|Secondary|Time From Randomization to First Documented AF Recurrence in Patients With Sinus Rhythm 48 Hours After Cardioversion|Excluding patients with early relapses (within 48 hours) while the study drug, started after cardioversion, had not yet reached steady-state.|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion||Days||95% Confidence Interval|Median
34203|NCT01534962|Secondary|Number of Patients With Documented and Confirmed AF Recurrences||16 weeks (112 days)|Intention-to-Treat||participants|||Number
34204|NCT01534962|Secondary|Time From Randomization to First Documented and Confirmed AF Recurrence|A confirmed AF recurrence was defined as a documented AF recurrence which was confirmed by a consecutive ECG performed at least 1 hour after first AF documentation.|16 weeks (112 days)|Intention-to-Treat (N=238)||Days||95% Confidence Interval|Median
34205|NCT01534962|Secondary|Number of Patients With Documented AF Recurrences||16 weeks (112 days)|Intention-to-Treat (N=238)||participants|||Number
34206|NCT01534962|Primary|Time From Randomization to First Documented AF Recurrence.|"Time to first AF recurrence reported by patient-reported TT-ECG or 12-Lead ECG at the study site, whichever occurred first.~Patients discontinuing the study without AF were censored at the time of the last available ECG."|16 weeks (112 days)|Intention-to-treat-approach that analyzed all randomised patients who took at least one dose of study medication (N=238, i.e. excluding 3 randomized patients).||Days||95% Confidence Interval|Median
34207|NCT01534910|Secondary|Carotid IMT|intima-media thickness|1 year||||||
34208|NCT01534910|Secondary|Serum Biomarkers|cholesterol, inflammatory markers, oxidative biomarkers.|1 year||||||
34209|NCT01534910|Primary|CT Angiography Plaque|"we measured low attenuation plaque at baseline (in volume) and then again at 1 year. In a double-blinded analysis, there was reduction in low attenuation plaque volume (percent of change from baseline, defined as [followup-baseline]/baseline x100%.~Baseline was time zero, followup CT scan was 1 year. For this measure (Low attenuation plaque), we had 28 interpretable baseline and follow up images to use in placebo(sugar pill), for Aged garlic extract, we had 27 interpretable paired data sets (both baseline and follow up had to be interpretable to use the measure)."|1 year|||percentage of low attenuation plaque||Standard Deviation|Mean
34210|NCT01534910|Secondary|Coronary Calcium||1 year||||||
34211|NCT01534689|Secondary|Change in Percent (%) of mm Clear Nail|Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.|12 weeks|||percentage of change in mm clear nail||Standard Deviation|Mean
34212|NCT01534689|Secondary|Change in Millimeter (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.|12 weeks|||millilmeters||Standard Deviation|Mean
34213|NCT01534689|Primary|Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail|"Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success.~Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria."|12 weeks|||percentage of toenails|||Number
34214|NCT01534676|Primary|Non-transferrin-bound Iron Level||2 hours after transfusion|Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed.|||||
34215|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs||Week 5|||participants|||Number
34216|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs||Week 1|||participants|||Number
34217|NCT01534637|Primary|Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation|Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.|Over 10 weeks|||participants|||Number
34218|NCT01534533|Secondary|Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods|Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||12/3333||||
34219|NCT01534533|Secondary|Dietary Intake of Energy During the Study Periods|Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||12/3333||||
34220|NCT01534533|Secondary|Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months|Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).|at baseline and after 12 months||12/3333||||
34221|NCT01534533|Primary|Table 1 Study Specific Characteristic of Serum Carotenoids|serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||μg/ml||Standard Deviation|Mean
34222|NCT01534533|Primary|Table 1 Study Specific Characteristic of Blood Pressure (BP)|systolic BP and diastolic BP in four groups was measure twice between 15minutes|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||mm Hg||Standard Deviation|Mean
34223|NCT01534533|Primary|Table 1 Study Specific Characteristic of Body Mass Index (BMI)|the mean and standard deviation of BMI in four groups was calculated|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||Kg/m^2||Standard Deviation|Mean
34224|NCT01534533|Primary|Table 1 Study Specific Characteristic of Age|the mean and standard deviation of age was calculated in four groups|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||years||Standard Deviation|Mean
34225|NCT01534533|Primary|Table 1 Study Specific Characteristic Part One|The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.||Percentage of Participants|||Number
34226|NCT01534520|Secondary|Need for Pain Medication up to 7 Days|Number of women taking pain medication for at least one day following IUD insertion|7 days post-insertion|||participants|||Number
34227|NCT01534520|Secondary|Percentage of IUDs Considered by Physicians Easy to Insert|"The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be easy was calculated for each study group."|Directly after IUD insertion|Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later.||percentage of insertions declared easy||95% Confidence Interval|Number
34228|NCT01534520|Secondary|To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD|"Number of participants who rated self-application of study gel as some what easy or very easy on Likert scale"|After inserting the gel but prior to IUD insertion|||participants who found gel easy to use|||Number
34229|NCT01534520|Primary|Change in Pain From Baseline to IUD Insertion|To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient’s life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).|change in pain score from baseline (before IUD insertion) to time of IUD insertion|||change in visual analog scale score||Inter-Quartile Range|Median
34230|NCT01534351|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 52 weeks|All Participants as Treated (APaT) - population consists of all randomized participants who received at least one dose of study treatment. As only one participant was randomized in the study, no analyses were performed.||Participants|||Number
34231|NCT01534351|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 54 weeks|||Participants|||Number
34232|NCT01534351|Primary|Percent Change From Baseline in Prostate Volume|Prostate volume was assessed by trans-rectal ultrasound (TRUS).|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.|||||
34233|NCT01534351|Primary|Change From Baseline in International Prostate Symptom Score (IPSS)|The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.|||||
34234|NCT01534208|Primary|Change From Baseline in FSH|Change from baseline in FSH at end of treatment (26 weeks)|6 months|||U/L||Standard Deviation|Mean
34235|NCT01534208|Primary|Change From Baseline in BMI|Mean change from baseline in BMI at end of treatment (26 weeks)|6 months|ITT||kg/m2||Standard Deviation|Mean
34236|NCT01534208|Primary|Mean Change From Baseline FPG|Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)|6 months|||mg/dL||Standard Deviation|Mean
34237|NCT01534208|Primary|Absolute Values of Morning Testosterone|Absolute values of morning testosterone at end of treatment (26 weeks)|6 months|ITT||ng/dL||Standard Deviation|Mean
34238|NCT01534208|Primary|Change From Baseline in LH|Mean change from baseline in LH at end of treatment (26 weeks)|6 months|ITT||mIu/mL||Standard Deviation|Mean
34239|NCT01534208|Primary|Change From Baseline in Total Morning Testosterone at 26 Weeks|Changes in values from baseline of total morning testosterone levels at Week 26|6 months|Intent to Treat population||ng/dL||Standard Deviation|Mean
34240|NCT01534182|Secondary|Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)|The SF-36 is a health-related quality of life instrument used in numerous disease states, including MS (Brazier et al 1992). It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each domain was scored by adding the individual items from the domain and transforming the resulting scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, 6 months|Participants from the full analysis set were considered for this analysis. However, for a given time frame, participants analyzed had both baseline and 6 month asssessment values.||scores on scale||Standard Deviation|Mean
34241|NCT01534182|Secondary|Change in Patient-reported Depression|The Beck Depression Inventory (BDI-I) scale was used to measure this outcome. The scale consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each item was scored from 0 - 3. If more than one score was provided for an item, the maximum score was considered the item score. The total score was calculated as the sum of all individual items and then compared to a key to determine the depression's severity. The standard key ranges were: 0 - 9 indicated minimal depression; 10 - 18 indicated mild depression; 19 - 29 indicated moderate depression and 30 - 63 indicated severe depression. Higher total scores indicate more severe depressive symptoms.|Baseline, 6 months|FAS: The LOCF method was applied.||scores on a scale||Standard Deviation|Mean
34242|NCT01534182|Secondary|Changes in Patient-reported Effectiveness, Side Effects and Convenience|TSQM v 1.4 domains for effectiveness, side effects and convenience were used to evaluate this outcome. The effectiveness domain for items 1 - 3 was scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the side effects domain, item 4 scored as 0(no) or 1(yes); item 5 scored as 1 (extremely bothersome) to 5 (not at all bothersome); and items 6 - 8 scored as 1 (a great deal) to 5 (not at all). For the convenience domain, items 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and item 11 scored as 1 (extremely inconvenient) to 7 (extremely convenient). For each domain, scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|FAS: The LOCF method was applied.||scores on a scale||Standard Deviation|Mean
34243|NCT01534182|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|6 months|Safety Set: This set included all randomized participants who received at least one dose of study medication.||Participants|||Number
34244|NCT01534182|Primary|Change in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|Full Analysis Set (FAS): This set included all randomized participants who had taken at least one dose of study medication and had at least one post-baseline assessment of the TSQM. The last observation carried forward (LOCF) method was applied.||scores on a scale||Standard Deviation|Mean
34245|NCT01534143|Secondary|Recovery of T-cell, B Cell and NK Cell Phenotypes||Days 30, 60, 90, and at 6 months after transplant||||||
34246|NCT01534143|Secondary|Progression Free Survival||From the day of transplant to progression, death, or last contact, assessed up to 2 years||||||
34247|NCT01534143|Secondary|Overall Survival||Up to 2 years post transplant||||||
34248|NCT01534143|Secondary|Incidence of Opportunistic Infections Including CMV, HSV, and EBV Reactivation||Weekly to day 100||||||
34249|NCT01534143|Secondary|Incidence and Severity of Chronic GVHD||Up to 2 years post transplant||||||
34250|NCT01534143|Secondary|Incidence of SOS||Up to 2 years post transplant||||||
34251|NCT01534143|Secondary|Incidence of TTP||Up to 2 years post transplant||||||
34252|NCT01534143|Secondary|Incidence of Transplant Related Mortality and Morbidity||Up to 2 years post transplant||||||
34253|NCT01534143|Secondary|Incidence of Myeloma Progression||Time to the first observation of disease progression/relapse post transplant, assessed up to 2 years post transplant||||||
34254|NCT01534143|Primary|Grade III and IV Non Hematologic Toxicities|Based on NCI CTCAE version 4.|First 6 months post transplant||||||
34255|NCT01534143|Primary|Treatment Related Mortality Defined as Death in Continuous or Complete Remission|Based on National Cancer Institute (NCI) CTCAE version 4.|From the date of transplant to the date of death, assessed up to 6 months post transplant||||||
34256|NCT01534143|Primary|Time to Platelet Absolute Neutrophil Recovery (Engraftment)|Estimated using Kaplan-Meier method.|First 6 months post-transplant||||||
34257|NCT01534143|Primary|Incidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin|Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.|First 6 months post-transplant||||||
34258|NCT01533974|Primary|Number of Participants Who Stopped Smoking by 12 Month Post Treatment|30 day point prevalence abstinence at 12 months. Missing = smoking and self report.|12 months|||participants|||Number
43428|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
34259|NCT01533935|Secondary|FEV1 (1 Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose).~The presented means are adjusted means from MMRM model."|6 weeks|All patients in FAS with available FEV1 data at baseline and week 6 are included in the analysis.||Litres||Standard Error|Mean
34260|NCT01533935|Secondary|Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).~Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.~A decrease in slope indicates improvement.~The presented means are adjusted means from MMRM model."|6 weeks|FAS||units on a scale / s||Standard Error|Mean
34261|NCT01533935|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted mean from the MMRM model."|6 weeks|FAS||seconds||Standard Error|Geometric Mean
34262|NCT01533935|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.||Litres||Standard Error|Mean
34263|NCT01533922|Secondary|Forced Expiratory Volume in 1 Second (One Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose)~The presented means are adjusted means from MMRM model."|6 weeks|FAS||Litres||Standard Error|Mean
34264|NCT01533922|Secondary|Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).~Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.~A decrease in slope indicates improvement.~The presented means are adjusted means from MMRM model."|6 weeks|FAS||units on a scale / second||Standard Error|Mean
34265|NCT01533922|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted mean from the MMRM model."|6 weeks|FAS||seconds||Standard Error|Geometric Mean
34266|NCT01533922|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.||Litres||Standard Error|Mean
34267|NCT01533753|Secondary|Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)|Assess percent change in quality of life from baseline to cycle 6, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.|over the 6 month treatment period|Zero participants analyzed due to early termination of study|||||
34268|NCT01533753|Secondary|Assess Changes in the Hot Flash Scores for the Two Arms|Assess percentage changes in the hot flash score from baseline to cycle 6 between gabapentin and venlafaxine in men with prostate cancer treated with for hot flashes related to androgen deprivation therapy|6 month treatment period|Zero participants analyzed due to early termination of study|||||
34269|NCT01533753|Secondary|Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups|Toxicity rates will be compared between the two groups|over a 6 month treatment period|Zero participants analyzed due to early termination of study|||||
34270|NCT01533753|Primary|Changes in Quality of Life|We will measure the absolute change in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy|observed over a 6 month treatment period|Zero participants analyzed due to early termination of study.|||||
34271|NCT01533597|Secondary|Change of Qmax|maximal urinary flow rate (Qmax) assessed by uroflowmetry|at week 24 relative to baseline|||mL/sec||95% Confidence Interval|Mean
34272|NCT01533597|Secondary|Change of PVR|Change from baseline in Post-Void Residual (PVR) volume|at week 24 relative to baseline|||mL||95% Confidence Interval|Mean
34273|NCT01533597|Secondary|Change in Score of IPSS|Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.|at week 24 relative to baseline|||units on a scale||95% Confidence Interval|Mean
34274|NCT01533597|Secondary|Change in Total Score of OABSS|Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)|at week 24 relative to baseline|||units on a scale||95% Confidence Interval|Mean
34275|NCT01533597|Secondary|Numeric Change of Urgency Episodes Per 24 Hours||at week 24 relative to baseline|||episodes||95% Confidence Interval|Mean
34277|NCT01533493|Primary|Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)|"This is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales: Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Example item: I make careless errors when completing tasks. Items are rated 1 Never, 2 Sometimes, or 3 Often. The Global Executive Composite (GEC) Score is calculated by totaling all items on the scale. GEC T-scores range from 34-108, with higher scores indicating more difficulties with executive function."|baseline, 12 weeks|||percentage change from baseline score||Standard Deviation|Mean
34278|NCT01533428|Secondary|Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12|Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12|Baseline to Week 12|Safety Analysis Set (SAF)||participants|||Number
34279|NCT01533428|Secondary|Number of Participants Who Used Rescue Pain Medication Days 1 Through 5|Summarized number of participants who used Rescue Pain Medications for Pain|Days 1 - 5|Safety Analysis Set (SAF)||participants|||Number
34280|NCT01533428|Secondary|"Change From Pre-application inPain Now Score"|"Change from pre-application inPain Now score was measured on a scale from 0-10 where 0 equates to No Pain and 10 to Pain as bad as you can imagine. Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment."|Pre-application and 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)||units on a scale||Standard Deviation|Mean
34281|NCT01533428|Secondary|Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.|Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal.|Day 1, 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)||participants|||Number
34282|NCT01533428|Secondary|Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12|"Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies “pain does not interfere with sleep” and 10 identifies “pain completely interferes with sleep. Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12."|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||percentage of change||Standard Deviation|Mean
34283|NCT01533428|Secondary|Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12|"Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question Over the past 7 days, how much has the study treatment improved your pain level?"|Baseline, Weeks 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
34284|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
34285|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
34286|NCT01533428|Secondary|Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12|Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0–100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
34287|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12|Baseline to Week 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
34288|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8|Baseline to Week 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
34289|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2|Baseline to Week 2|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||participants|||Number
34290|NCT01533428|Secondary|Percentage of Participants With 50% Reduction in Average Daily Pain Score.|Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.||percentage of participants|||Number
34291|NCT01533428|Secondary|Percentage of Participants With 30% Reduction in Average Daily Pain Score.|Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.||percentage of participants|||Number
34292|NCT01533428|Secondary|Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline|Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline and Weeks 2, 4, 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||units on a scale||Standard Deviation|Mean
34293|NCT01533428|Secondary|Weekly Percent Change From Baseline in Average Daily Pain Score|Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12|Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used.||percentage change||Standard Deviation|Mean
34294|NCT01533428|Secondary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12|Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||percentage change||Standard Deviation|Mean
34295|NCT01533428|Primary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8|Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 to 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.||percentage change||Standard Deviation|Mean
34296|NCT01533259|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Weeks 24 and 48|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
34297|NCT01533259|Secondary|Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities|This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.|Up to 48 weeks plus 30 days|Safety Analysis Set||percentage of participants|||Number
34298|NCT01533259|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 12|Full Analysis Set: participants who received at least one dose of study drug and had no major protocol violations of study drug resistance at baseline.||percentage of participants||95% Confidence Interval|Number
34299|NCT01533246|Secondary|Progression Free Survival|Progression Free survival (PFS) time was measured as the time from the date of on study up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.|assessed up to 2 years|Patients that received treatment||Months||Full Range|Median
34300|NCT01533246|Secondary|Overall Survival Based on the RECIST v1.1|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|Up to 2 years|Patients that received treatment||Months||Full Range|Median
34301|NCT01533246|Secondary|Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved.|assessed up to 12 weeks|Patients that received treatment.||months||95% Confidence Interval|Median
34302|NCT01533246|Secondary|Number of Patients With Bidimensional Measurable Disease RECIST-based Response|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|Up to 2 years|Patients with soft tissue disease only||participants|||Number
34303|NCT01533246|Secondary|Incidence of Toxicities Based on CTCAE Version 4.0 Criteria|Number of patients with at least possibly related to treatment toxicities grade 3 or higher based on Common Terminology Criteria for Adverse Events.|Up to 2 years|Patients that received treatment||participants|||Number
34304|NCT01533246|Primary|PSA Response Analyzed Using the PCWG2 Definition|Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.|12 weeks|Patients that received treatment||participants|||Number
34305|NCT01533181|Other Pre-specified|Changes in Biomarker Expression|To be assessed by the Wilcoxon rank sum test.|Baseline to up to day 1 of course 3||||||
34306|NCT01533181|Secondary|Overall Survival (OS)|OS: Time from study enrollment to death from any cause. OS summarized similarly to PFS utilizing the K-M method.|Up to 2 years|All participants who received treatment||months||95% Confidence Interval|Median
34307|NCT01533181|Secondary|Incidence of Serious Adverse Events (SAEs) Possibly/Probably Definitely Related to Study Drugs|Participants with Grade 3 and 4 toxicities, possibly/probably/definitely related to study drugs. Number of Participants is per Event Category. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|1 year, 6 months|All participants who received treatment||participants|||Number
34308|NCT01533181|Secondary|Disease Control Rate (DCR)|DCR: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) + Progressive Disease (PD). DCR summarized using both point estimates and exact confidence intervals based on the binomial distribution by arm.|Up to 2 years|All evaluable participants at time of analysis||participants|||Number
34309|NCT01533181|Primary|Median Progression Free Survival (PFS)|PFS: Time from randomization to time of disease progression or death. PFS summarized with the Kaplan-Meier (K-M) method by two arms (experimental versus control). Confidence intervals for the median PFS and PFS rates at different time points to be constructed when appropriate.|Up to 6 months|All participants who received treatment||months||95% Confidence Interval|Median
34310|NCT01533116|Primary|AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose|AUEC0-24 - Area under the effect-time curve (AUEC) to 24 h post-dose.|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||pmol/mg Hb/h.h||Standard Deviation|Mean
34311|NCT01533116|Primary|tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity|tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||hours||Standard Deviation|Mean
34312|NCT01533116|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||ng.h/mL||Standard Deviation|Mean
34313|NCT01533116|Primary|Tmax - Time to Maximum Plasma Concentration|Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||hours||Full Range|Median
34314|NCT01533116|Primary|Cmax - Maximum Plasma Concentration|Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)||ng/mL||Standard Deviation|Mean
34315|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34316|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34352|NCT01532869|Secondary|Percentage of Participants With Anti-Tocilizumab Antibody||Baseline, and post-baseline (up to Week 48)|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure.||percentage of participants|||Number
34317|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (BIA 9-1067)|Pharmacokinetic parameters of BIA 9-1067. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
34318|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
34319|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34320|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34321|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
34322|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
34323|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34324|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34325|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (3-OMD)|Pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD). For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
34326|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
34327|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34328|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng.h/mL||Standard Deviation|Mean
34329|NCT01533077|Primary|Tmax - Time of Occurrence of Cmax Maximum Observed Plasma Concentration (L-DOPA)|Pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA). For tmax = time to Cmax values are presented as median with range values.|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||hours||Full Range|Median
34330|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.||ng/mL||Standard Deviation|Mean
34331|NCT01533038|Primary|Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met|"LUTS: ≥ 30% reduction in IPSS compared to baseline~Recovery Experience: Return to pre-operative activity levels by 1 month~Erectile function: Less than 6-point reduction in SHIM compared to baseline.~Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response Could not ejaculate~Continence: ISI score of 4 points or less at all follow-up time points~Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up."|Month 12|||% Responders of Participants|||Number
34332|NCT01532999|Secondary|PTSD Remission|Total CAPS score of less than or equal to 45 at week 9 (single observation point)|Week 9|All participants who were randomized and attended at least one intervention session.||percentage of participants|||Number
34333|NCT01532999|Secondary|PTSD Response|Greater than or equal to 30% improvement on PTSD CAPS scale|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||percentage of participants|||Number
34334|NCT01532999|Secondary|Change From Baseline in CAPS D Subscale|Clinician Administered PTSD Scale (CAPS) D subscale measures the hyperarousal cluster (i.e. D criterion) of PTSD symptoms and includes the items 13 - 17 of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
34335|NCT01532999|Secondary|Change From Baseline in CAPS C Subscale|Clinician Administered PTSD Scale (CAPS) C subscale measures the avoidance and emotional numbing cluster (i.e. C criterion) of PTSD symptoms and includes the items 6 - 12 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 56 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
34336|NCT01532999|Secondary|Change From Baseline in CAPS B Subscale|Clinician Administered PTSD Scale (CAPS) B subscale measures the re-experiencing cluster (i.e. B criterion) of PTSD symptoms and includes the first 5 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
34337|NCT01532999|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9)|Patient Health Questionnaire (PHQ-9) is a brief 9-item measure of depressive symptoms that has established reliability and validity in community and clinical populations. All items are summed for total score ranging from 0 to 27 (higher score = more severe depression).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
34338|NCT01532999|Secondary|Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)|"Five Facet Mindfulness Questionnaire (FFMQ) is used to evaluate the effects of MBSR vs. PCGT on mindfulness (S1). The FFMQ is a 39-item self-report instrument that assesses the general tendency to be mindful in daily life through 5 facets: observing, describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. Increases in FFMQ mediate improvements in well being in observational studies of MBSR. Each item is rated 1 to 5 (never or very rarely true to very often or always true). Some of the items are reverse scored (R). Scoring Information: Observe items:1, 6, 11, 15, 20, 26, 31, 36; Describe items: 2, 7, 12R, 16R, 22R, 27, 32, 37; Act with Awareness items: 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R; Nonjudge items: 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R; Nonreact items: 4, 9, 19, 21, 24, 29, 33. Total all subscales for score (higher score = greater degree of mindfulness). Score range 39-195 with higher=more mindfulness."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
34339|NCT01532999|Secondary|Change From Baseline in PTSD Checklist (PCL)|"PTSD Checklist (PCL) is a 17-item self-report scale intended to measure PTSD symptom severity. The PCL has demonstrated excellent internal consistency (alpha = .94-.97), and test-retest reliability over 2 to 3 days was .96 for Vietnam veterans. Respondents rate each item from 1 (not at all) to 5 (extremely) to indicate the degree to which they have been bothered by that particular symptom over the past month. Thus, total possible scores (items summed) range from 17 to 85 (higher score is more severe). A cut-off score of 50 indicates a probable diagnosis of PTSD."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
34340|NCT01532999|Primary|Change From Baseline in Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item standard rating scale that measures PTSD severity with scores ranging from 0-136 (higher score = more severe). Scores of frequency and intensity are summed for the 17-items to yield the total CAPS score.|Baseline to week 9|All participants who were randomized and attended at least one intervention session.||units on a scale||Standard Deviation|Mean
34341|NCT01532973|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.|Up to 5 days|All participants who received at least 1 dose of study drug. Event summarized by drug taken at time of event and not by panel or genotype||Participants|||Number
37111|NCT01491035|Primary|Oral Clearance (CL/F) of Vortioxetine|Oral clearance expressed as a function of bioavailability|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||L/h||Standard Deviation|Median
34342|NCT01532973|Primary|Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|Up to 5 days|All participants who received at least 1 dose of study drug. Events reported by drug taken at time of event and not by panel or genotype||Participants|||Number
34343|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.||IU/mL||95% Confidence Interval|Least Squares Mean
34344|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
34345|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
34346|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.||IU/mL||95% Confidence Interval|Least Squares Mean
34347|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
34348|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.||IU/mL||95% Confidence Interval|Least Squares Mean
34349|NCT01532934|Secondary|New Criminal Charge|New criminal charge vs. no new criminal charge at follow-up as indicated by county database.|one year|||participants|||Number
34350|NCT01532934|Secondary|Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)|A measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.|six months|||units on a scale||Standard Deviation|Mean
34351|NCT01532934|Primary|Percent Days Abstinent Per Month From Drug Use|Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.|three to six months post baseline|105 adults (68 men and 37 women) were recruited in an urban pretrial jail diversion program. 78 (74.3%) were retained through six months. Of these, 73 were out of controlled environments (e.g., jail, inpatient treatment) for long enough to have their substance use data analyzed.||percentage of days abstinent||Standard Deviation|Mean
37112|NCT01491035|Primary|t½ of Lu AA34443|Half-life of the major, inactive metabolite Lu AA34443 in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||h||Standard Deviation|Median
34353|NCT01532869|Secondary|Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||pg/mL||Standard Deviation|Mean
34354|NCT01532869|Secondary|Mean Serum Concentrations of Interleukin (IL)-6 by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||picograms per milliliters (pg/mL)||Standard Deviation|Mean
34355|NCT01532869|Secondary|Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)|AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (*) hour per milliliters (µg*hr/mL). It is used to characterize drug absorption.|Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16|Pharmacokinetic (PK) population included all participants who received at least one TCZ injection and had at least one PK sample with detectable results. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.||µg*hr/mL||Standard Deviation|Mean
34356|NCT01532869|Secondary|Change From Baseline in Tender Joint Count 28 (TJC28)|Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.|Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48|ITT population. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.||joint count||Standard Deviation|Mean
34357|NCT01532869|Secondary|Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline <0) that maintained or further improved at Week 48 were reported as “Yes” and “No” with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 <= change from baseline at Week 24.|Week 48|ITT population. Here number of participants analyzed included those with mRSS change from baseline <0 at Week 24 and with non-missing change from baseline in mRSS at Week 48.||percentage of participants|||Number
34358|NCT01532869|Secondary|Change From Baseline in mRSS at Week 48|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at specified time point up to 48 weeks.||unit on a scale||95% Confidence Interval|Least Squares Mean
34359|NCT01532869|Secondary|Change From Baseline in 5-D Itch Scale at Week 24 and Week 48|The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||units on a scale||95% Confidence Interval|Least Squares Mean
34360|NCT01532869|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48|This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant’s condition.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||units on a scale||95% Confidence Interval|Least Squares Mean
34361|NCT01532869|Secondary|Change From Baseline in Patient’s Global Assessment at Week 24 and Week 48|The Patient’s Global Assessment was a patient's reported outcome that represented the participant’s overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||mm||95% Confidence Interval|Least Squares Mean
34362|NCT01532869|Secondary|Change From Baseline in Clinician’s Global Assessment at Week 24 and Week 48|The Clinician’s Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||mm||95% Confidence Interval|Least Squares Mean
34380|NCT01532570|Secondary|Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, Week 14, Week 30, Week 54|||cells/mL|||Number
34363|NCT01532869|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48|The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant’s self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.||units on a scale||95% Confidence Interval|Least Squares Mean
34364|NCT01532869|Secondary|Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)|SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant’s disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant’s daily activities. Each VAS item was rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified timeframe.||mm||95% Confidence Interval|Least Squares Mean
34365|NCT01532869|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.|Week 48|Safety population.||percentage of participants|||Number
34366|NCT01532869|Primary|Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants randomized who had received any study drug at the time of the Week 24 cutoff date (14 January 2014). Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at any time point up to Week 24.||unit on a scale||95% Confidence Interval|Least Squares Mean
34367|NCT01532635|Secondary|Assessment for Tumor Escape Mechanisms|To test for loss of one or both HLA haplotypes in patients who relapse post-transplant and examine the relapse in the context of the characteristics of the 2 donors|1 year post transplant||||||
34368|NCT01532635|Secondary|Tolerance of DLI|Assessment of the tolerance of the period of fever, diarrhea, and rash after the introduction of second donor and qualitatively compare it to prior patient groups or concurrent patient groups|2-6 days prior to transplant||||||
34369|NCT01532635|Secondary|Non-relapse Morbidity and Mortality|Assessment of regimen related toxicity, GVHD incidence and severity, and overall survival.|1 year||||||
34370|NCT01532635|Secondary|Immune Reconstitution|Assess T and B cell Reconstitution|1 year||||||
34371|NCT01532635|Secondary|Engraftment|To assess the consistency and pace of engraftment of both donors.|1 year||||||
34372|NCT01532635|Secondary|Relapse Rates|To assess if establishment of a dominant donor versus persistent chimerism of both donors is associated with a lower relapse rate.|1 year||||||
34373|NCT01532635|Secondary|Assessment of Dominance|If dominance is observed, to compare the 2 donors with regard to degree of HLA mismatch, KIR types, CD 34+ cell doses, infusion order, donor age, and donor alloreactivity points in an effort to identify potential biologic factors that predict for dominance. To determine if trends toward dominance occur in T cell, NK cell, or other cellular subsets prior to emerging in the graft as a whole.|1 year||||||
34374|NCT01532635|Secondary|Chimerism Assessment|To assess chimerism to ascertain whether one donor is emerging as dominant at regular intervals beginning at the time of engraftment.|1 year||||||
34375|NCT01532635|Primary|One Year Relapse-Free Survival|"To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors.~Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover."|1 year||||||
34376|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients|"The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||participants|||Number
34377|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients|"The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||participants|||Number
34378|NCT01532570|Secondary|The Number of Improved Intestinal BD Patients From Baseline|"The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as  No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor.~We calculated improved patients in comparison with those for Week 0."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||participants|||Number
34379|NCT01532570|Secondary|Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD||Week 0, Week 14, Week 30, Week 54|||pg/mL|||Number
34381|NCT01532570|Secondary|Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||mm/hr||Inter-Quartile Range|Median
34382|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (CRP) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||mg/dL||Inter-Quartile Range|Median
34383|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||mg/dL||Inter-Quartile Range|Median
34384|NCT01532570|Secondary|Imaging Findings: CT, PET/CT for Vascular-BD|"Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, Improves, Unchanged or Worsened by comparison with those at Week 0."|Week 14, Week 30, Week 54|||participants|||Number
34385|NCT01532570|Secondary|Imaging Findings: Brainstem MRI for Chronic Neuro-BD|"Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, Unchanged or Reduced in the brainstem area compared to Week 0."|Week 14, Week 30, Week 54|||participants|||Number
34386|NCT01532570|Secondary|Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD|"Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, No high-intensity areas, Reduction or No changes/increase in the size of high-intensity areas compared to Week 0."|Week 14, Week 30, Week 54|||participants|||Number
34387|NCT01532570|Secondary|Imaging Findings:Endoscopic Examination for Intestinal BD|"The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, Healed/scarred, Reduced to =< 25%, Reduced to > 25% to =< 50% or Reduced to > 50%/no change/increased in the principal intestinal ulcer compared to size at Week 0."|Week 14, Week 30, Week 54|||participants|||Number
34388|NCT01532570|Secondary|Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD|"The VAS evaluation measured using the General VAS evaluation From and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as 0 and the worst condition is defined as 100.~The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54|||units on a scale||Standard Deviation|Mean
34389|NCT01532570|Secondary|Percentage of Participants With Complete Response at Week 14 and 54|"We defined the patient who met the following criteria as the complete responders.~The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 14, Week 54|||percentage of Complete Responders|||Number
34390|NCT01532570|Primary|Percentage of Participants With Complete Response at Week 30|"We defined the patient who met the following criteria as the complete responders.~The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 30|||percentage of Complete Responders|||Number
34391|NCT01532453|Secondary|Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas||2 Years|"The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.~For patient 10018 (MD-3511356 group) the age of first organ transplant was not computable due to missing date."||percentage of patients|||Number
34392|NCT01532453|Primary|Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas||2 Years|241 patients were randomized: 160 to the MD 3511356 group and 81 to the standard care group. All 241 randomized patients received at least one dose of trial device and therefore were all included in the safety population. The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.||new actinic keratoses or scc||Standard Deviation|Mean
34393|NCT01532414|Primary|Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT.||percentage of participants|||Number
34394|NCT01532414|Primary|Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range|"Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.||Percentage of Subjects|Participants|95% Confidence Interval|Number
34564|NCT01528332|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5|The RMDQ is a 24 list of yes/no questions about the effects of back pain on the participants daily activities. Each positive answer is a point; maximum total score = 24.|Baseline (days -7 to +1) to Treatment 5 (day +14)||||||
34395|NCT01532362|Secondary|Effect of Apricoxib on Levels of CD4+CD25+ T Regulatory Cells in Peripheral Blood.Also,Biomarkers of Apoptosis Resistance,Angiogenesis,Invasion and Immunity Will be Tested in the Lab to Check How Effective Apricoxib is in Inhibiting These Proteins.|Peripheral blood from patients with NSCLC has been reported to have an increase in the percentages of CD4+CD25+ T reg cells.In contrast <10% of the PBLs of normal donors have this phenotype. As such, CD4+CD25+ cells will be assessed in addition to FOXP3 levels in PBL. In addition, exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity will be studied. COX-2, FOXP3, IL-10, IL-12, MDC, CXCR4 and survivin will be analyzed in plasma.|7 days||||||
34396|NCT01532362|Primary|Compare Level of CD4+CD25high T Lymphocyte Regulatory Cells in Peripheral Blood Lymphocytes and Tumor Infiltrating Lymphocytes From Surgical Resection Specimens of Subjects With Early Stage NSCLC Who Have Received Apricoxib to Those Who Have Not|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision). Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7|7 days|No analysis occurred|||||
34397|NCT01532141|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng.h/mL||Standard Deviation|Mean
34398|NCT01532141|Secondary|Time of Occurrence of Cmax (Tmax)|6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers|pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||hours||Full Range|Median
34399|NCT01532141|Primary|Cmax - Maximum Observed Plasma Drug Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng/mL||Standard Deviation|Mean
34400|NCT01532128|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng.h/mL||Standard Deviation|Mean
34401|NCT01532128|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||hours||Full Range|Median
34402|NCT01532128|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose|||ng/mL||Standard Deviation|Mean
34403|NCT01531998|Secondary|Number of Participants With Response|Overall response defined as number of participants with International Myeloma Working Group Uniform Response Criteria: Complete Response (CR): Negative immunofixation serum & urine, Disappearance soft tissue plasmacytomas & =/<5% plasma cells in bone marrow; Stringent Complete Remission: CR + Normal Normal free light chain (FLC) ratio & Absence clonal cells in bone marrow by Immunohistochemistry/ immunofluorescence; Very Good Partial Response (VGPR): Serum & urine M-protein detectable by immunofixation but not on electrophoresis or 90%> reduction in serum M-protein +urine M-protein level <100mg per 24 hour; Partial Remission (PR): =/>50% reduction serum M-protein & reduction in 24-hour urinaryMprotein by >90% or to < 200mg per 24 hour, =/>50% reduction of serum M-protein & reduction in 24-hour urinary Mprotein by >90%/or <200mg, and if present at baseline, a >50% reduction in size of soft tissue plasmacytomas; Stable Disease: Not CR, VGPR, PR Or Progressive disease|Evaluated after eight cycles of 21 days.|||participants|||Number
34404|NCT01531998|Primary|Maximum Tolerated Dose (MTD) of Siltuximab|Maximum tolerated dose (MTD) defined as follows: At first dose level, if greater than 1 out of 3 patients or greater than 1 out of 6 patients experience dose limiting toxicity (DLT), the dose level exceeds the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) defined as toxicities graded in severity according to the guidelines outlined in the NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.|21 days|||mg/kg|||Number
34405|NCT01531725|Secondary|Major Adverse Cardiac Events (MACE)|MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.|at 180 days post procedure|Patients with follow up available either 180 or 360 days post procedure.||participants|||Number
34406|NCT01531725|Primary|Target Vessel Failure (TVF)|Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.|at 180 days post procedure|Patients with follow up data available either 180 or 360 days post procedure.||participants|||Number
34407|NCT01531387|Secondary|Quality of Life|Standard Quality of Life measure will be taken during specific time points, as well as one newly-developed Sickle Cell Disease Quality of Life measure.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
34408|NCT01531387|Secondary|Cumulative Incidence of Non-Neurological Events|The cumulative incidence of non-neurological sickle cell-related events, including vaso-occlusion and splenic sequestration, will be estimated over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
34409|NCT01531387|Secondary|Cumulative Incidence of Neurological Events|The cumulative incidence of neurological events as a secondary endpoint, which include both stroke and non-stroke neurological events, will be determined over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
34410|NCT01531387|Secondary|Serial TCD Velocities|This secondary outcome measure will be the highest TAMV obtained in specific arteries. Serial TCD velocities are measured throughout the SCATE trial and will be compared to the baseline value.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.|||||
34439|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
34411|NCT01531387|Primary|Conversion to Abnormal Maximum TAMV|The primary endpoint of the SCATE trial is the cumulative incidence of conversion to abnormal maximum TAMV (time-averaged mean velocity) measured by transcranial doppler (TCD) ultrasonography. Subjects must have conditional velocities at baseline, defined as 170 - 199 cm/sec, which indicate moderate stroke risk. Abnormal velocities are defined as ≥ 200 cm/sec, which indicate high stroke risk. The number of conversions from conditional velocities to abnormal velocities in each treatment arm will be compared as the primary outcome.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the primary outcome measure was not analyzed.|||||
34412|NCT01531335|Secondary|Insulin Requirements|This is an indirect measure of glycemic control, and is reported as a daily average.|Daily until day 21 or discharge from ICU|||International Unit of insulin||Standard Deviation|Mean
34413|NCT01531335|Primary|SOFA (Sequential Organ Failure Assessment) Score|SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).|48 hours since nutritional regime starts|||units on a scale||Standard Deviation|Mean
34414|NCT01531205|Secondary|Incidence of Detecting Circulating Tumor Cells (CTC)|To determine the feasibility of detecting circulating tumor cells in this patient population. CTC results per patient in milliliters.|One Year|All participants||CTC/mL|||Number
34415|NCT01531205|Secondary|Incidence of Perioperative and Postoperative Morbidity|Number of events. To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.|One Year|Participants who proceeded to surgery||events|||Number
34416|NCT01531205|Secondary|Incidence of Complete Response (CR)|Percentage of participants with CR post surgery. To evaluate the pathological complete response rate to androgen ablation plus Cabazitaxel in patients with locally recurrent prostate cancer following radiation therapy. Pathological Complete Response (pCR): Participants with no residual cancer in the local resection specimen and pelvic lymph nodes will be considered pCR.|One Year|Participants who proceeded to surgery||percentage of participants|||Number
34417|NCT01531205|Secondary|Incidence of PSA Progression Free Survival (PFS)|Percentage of participants with stable (has not increased) or undetectable PSA post surgery. To assess Prostate-specific antigen(PSA)-progression free survival and prostate cancer specific survival for patients treated by chemohormonal therapy followed by salvage surgery for biopsy proven androgen-dependent high-risk locally recurrent prostate cancer following radiation therapy.|Four Months|Participants who proceeded to surgery||percentage of participants|||Number
34418|NCT01531205|Primary|Surgical Margin Negative Rate (SM Rate)|Post surgery percentage of participants with negative surgical margin. To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy. Margin: The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|One Year|Participants who proceeded to surgery||percentage of participants|||Number
34419|NCT01530477|Primary|Short Term Precision Comparison Across Three DXA Devices|"BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the Skeletal & Body Composition cohort identified in participant flow and overall study summary will not have an analysis provided."|Less than 6 months|||Percentage of variance|||Number
34420|NCT01530464|Primary|Area Under the Curve Post Dosing (AUC_0-infinity) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing|||h*ng/ml||Standard Deviation|Median
34421|NCT01530464|Primary|Area Under the Curve Within 24 Hours Post Dosing (AUC_0-24 Hours) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing|||h*ng/ml||Standard Deviation|Median
34422|NCT01530464|Primary|Maximum Plasma Concentration (Cmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)|24h after dosing|||ng/ml||Standard Deviation|Median
34423|NCT01530464|Primary|Time Until Maximum Plasma Concentration (Tmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing|||hours||Standard Deviation|Median
34543|NCT01528605|Secondary|Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer|Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks|at baseline, 24, 48 weeks and 2 years during the intervention||12/2015||||
34424|NCT01530464|Primary|Plasma Halflife of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24 hours after dosing|||hours||Standard Deviation|Median
34425|NCT01530464|Primary|Mean Number of Adverse Events Following Each Dose|"Dosing schedule:~Aminophylline Alone (Single Dose of 500mg Aminophylline) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan and Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)"|48 h following each dose|||Mean number of adverse events||Standard Deviation|Mean
34426|NCT01530399|Primary|Chest Tube Drainage at 12 Hours After Surgery||12 hours post CABG|||mL||Inter-Quartile Range|Median
34427|NCT01530334|Secondary|Time to Worsening of Disease Related Symptoms|Time to worsening of disease related symptoms (LCS) Time to worsening of disease-related symptoms based on FACT-L LCS was defined as the interval from the date of enrollment to the first visit response of ‘worsened’ without a subsequent response of ‘improved’ or ‘no change’ within 21 days (or to the last assessment), death due to any cause, or early discontinuation from the study. Time to worsening was censored at the last non-missing assessment visit if the worsening was not observed.|every 6 weeks after the Start of Study Treatment until the worsening of desease related symptoms or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population||days|Participants|95% Confidence Interval|Median
34428|NCT01530334|Secondary|Treatment Duration With Gefitinib|Treatment duration was calculated from the date of the first to the date of the last intake.|every 6 weeks after the Start of Study Treatment until discontinuation of drug or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population||days|Participants|95% Confidence Interval|Median
34429|NCT01530334|Secondary|Overall Survival (OS)|OS was calculated as the time from the first dose until the day of death from any cause. Any patient not known to have died at the time of data analysis was censored at the time of the last follow-up date.|every 6 weeks after the Start of Study Treatment until death or time of data cut off (6 months after the last patient has started study treatment)|Analysis conducted both in FAS and EFS population||days|Participants|95% Confidence Interval|Median
34430|NCT01530334|Secondary|Progression Free Survival|Progression free Survival was calculated as the time from the first dose of gefitinib study treatment until the date of (i) progression or (ii) death from any cause in the absence of progression.|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|PFS was analysed on FAS and EFS population||Days|Participants|95% Confidence Interval|Median
34431|NCT01530334|Primary|Clinical Benefit Rate|"Clinical benefit rate is the sum of patients with a best visit response of Complete Response, Partial Response or Stable Desease Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.~Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions, Stable Desease (SD) defined as no progression for>= 6 weeks. Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|CBR was analyzed both on FAS and EFS population||Patients|Participants||Number
34432|NCT01530334|Primary|Objective Response Rate|"Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.~Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions; Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed both in the FAS population (i.e. all enrolled patients into the study) and in EFS population (i.e. all screened patients who entered and received at least one dose of study agent)||Patients|Participants||Number
34433|NCT01530243|Other Pre-specified|Pain|The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain.|Expected 2 weeks later|||units on a scale||Standard Deviation|Mean
34434|NCT01530243|Secondary|Quality of Life|The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.|Expected 2 weeks later|||units on a scale||Standard Deviation|Mean
34435|NCT01530243|Primary|Lower Urinary Tract Symptoms (LUTS)|LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.|Expected average of 2 weeks|The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.||units on a scale||Standard Deviation|Mean
34436|NCT01530087|Secondary|Security|wear time leakage barrier erosion|30 days|Study was stopped ; no data are available|||||
34437|NCT01530087|Primary|Peristomal Skin Condition|mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)|1 - 30 days|Study was stopped due to inability to inability to enroll. No data are available for any outcome measures.|||||
34438|NCT01529645|Primary|Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination|The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||percentages of subjects||95% Confidence Interval|Number
34544|NCT01528605|Secondary|Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention||at baseline, 24, 48 weeks and 2 years during the intervention||12/2015||||
34440|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
34441|NCT01529645|Primary|Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
34442|NCT01529645|Secondary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens|The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.|Day 30 post vaccination/Day 1|Analysis was done on the per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
34443|NCT01529645|Secondary|GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination|The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
34444|NCT01529645|Secondary|Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.|Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.|Day 30 post vaccination|Analysis was done on the per-protocol population.||percentage of subjects||95% Confidence Interval|Number
34445|NCT01529645|Primary|GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||µg/mL||95% Confidence Interval|Geometric Mean
34446|NCT01529645|Primary|GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.||µg/mL||95% Confidence Interval|Geometric Mean
34447|NCT01529645|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding.||µg/mL||95% Confidence Interval|Geometric Mean
34448|NCT01529645|Primary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.|From day 1 to day 365|Analysis was done on the safety set.||participants|||Number
34449|NCT01529645|Primary|The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.|Day 1 through 7 after vaccination|Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.||participants|||Number
34450|NCT01529632|Secondary|Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment|The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of 'nights with no nighttime awakenings'. The symptom variables for the whole active treatment period was analyzed using the similar MIXED model as for the primary endpoint, with the baseline FEV1 term being replaced by the respective baseline symptom variables.|28 days|The Modified per protocol set (PPS) was defined post-DBL and included all patients with available data and without any major protocol deviations or criteria or GCP finding causing exclusion. Patients were analyzed according to the treatment to which they were randomized.||percentage of days||Standard Deviation|Mean
34451|NCT01529632|Secondary|Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening) then a half day was used in the denominator.|Baseline and 28 days|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."||puffs||Standard Deviation|Mean
34452|NCT01529632|Secondary|Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28|Time course of Forced Expiratory Volume in 1 second (FEV1) was measured at -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|-45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28|The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion. Patients were analyzed according to the treatment to which they were randomized.||Liters||Standard Error|Least Squares Mean
34453|NCT01529632|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 min - 4 hr at Days 1 and 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
34454|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 28 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
34455|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
34456|NCT01529632|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 29|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."||Liters||Standard Error|Least Squares Mean
34457|NCT01529515|Secondary|Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase|The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||Units on a Scale||Standard Deviation|Mean
34458|NCT01529515|Secondary|Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase|The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||Units on a Scale||Standard Deviation|Mean
34459|NCT01529515|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||Units on a Scale||Standard Deviation|Mean
34582|NCT01527513|Secondary|Change From Baseline in Standardized Seizure Frequency - Part I||Baseline; Titration Period (4 Weeks: V2-V3-V4)|Modified Efficacy ITT population – all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||Seizures per week||Standard Deviation|Mean
34460|NCT01529515|Primary|Time to Relapse During the Double-Blind Phase|Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.|Approximately Week 60|The intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least one dose of Double-blind study agent.||Days||95% Confidence Interval|Median
34461|NCT01529450|Secondary|Molecular Markers Associated With Clinical Response|Following consent, historical biopsy samples were analyzed for molecular markers associated with clinical response. Tumors were analyzed and present of Smooth mutation (SMO [genetic changes which influence Ki 67 and Gli levels]). was determined. The number of participants with and without SMO were reported by clinical outcome (SD = stable disease; PD = progressive disease).|Assessed on day 1|Participants with tissue available for screening were analyzed.||participants|||Number
34462|NCT01529450|Primary|Progression Free Survival (PFS) of All Participants||End of treatment or at time of disease progression (up to 58 weeks)|Progression is defined using RECIST version 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion or the appearance of new lesion.||weeks||95% Confidence Interval|Median
34463|NCT01529385|Primary|Microcirculation for Dorsum of Foot|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage|||mmHg||95% Confidence Interval|Mean
34464|NCT01529385|Primary|Microcirculation for Lateral Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage|||mmHg||95% Confidence Interval|Mean
34465|NCT01529385|Primary|Microcirculation for Medial Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage|||mmHg||95% Confidence Interval|Mean
34466|NCT01529385|Secondary|Physical Activity Level|Physical activity monitors will be used to assess physical activity patters of participants for 48 hours prior to initiating sock usage and for 48 hours after the participants have worn the socks for four weeks.|baseline and after four weeks of wearing the socks|physical activity measurements were only made for a sub-sample of the study's complete sample||steps||Standard Deviation|Mean
34467|NCT01529385|Primary|Foot Edema|The circumference of the foot was measured by a tape measure.|change from baseline after 4 weeks of sock usage|||cm||95% Confidence Interval|Mean
34468|NCT01529385|Primary|Ankle Brachial Index|ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage|||unit-less ratio data||95% Confidence Interval|Mean
34469|NCT01529385|Primary|Toe Brachial Index|ratio of systolic blood pressure of toe relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage|||unit-less ratio data||95% Confidence Interval|Mean
34470|NCT01529385|Primary|Ankle Edema|The circumference of ankle was measured by a tape measure.|change from baseline after 4 weeks of sock usage|||cm||95% Confidence Interval|Mean
34471|NCT01529385|Primary|Calf Edema|The circumference of calf was measured by a tape measure.|change from baseline after 4 weeks of sock usage|||cm||95% Confidence Interval|Mean
34472|NCT01529385|Primary|Cutaneous Water Content|Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.|change from baseline after 4 weeks of sock usage|||percentage change in dielectric constant||95% Confidence Interval|Mean
34473|NCT01529203|Secondary|Related Adverse Event|Number of subjects reporting related adverse events|Month 6|||participants|||Number
34474|NCT01529203|Secondary|Global Aesthetic Improvement From Baseline|"The scale responses are: -1 indicating worse, 0 indicating no change, 1 indicating improved, 2 indicating much improved and 3 indicating very much improved."|Week 3|||percentage of total subjects|||Number
34475|NCT01529203|Primary|Subject Satisfaction for the Full Face|based on the subject's satisfaction questionnaire|Month 6|only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis||percentage of total subjects|||Number
34476|NCT01529112|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)|Blood samples were collected for lenvatinib PK analysis. Lenvatinib concentrations from sparse PK sampling were measured. The data is presented as mean nanograms per milliliter +/- Standard deviation of lenvatinib serum concentration.|Cycle 1/Day 1 (between 0.5 and 4 hours postdose and 6 and 10 hours postdose), Cycle 1/Day 15 (predose, between 0.5 and 4 hours postdose, and 6 and 10 hours postdose), and Day 1 of Cycles 2 though 4 (predose and between 2 and 12 hours postdose)|The analysis was performed using the pharmacokinetic (PK) analysis set defined as all subjects who received at least one dose of study drug and had evaluable PK data.||nanograms per milliliter||Standard Deviation|Mean
34477|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL|The EORTC module QLQ-LC13 symptom score was a self-reporting cancer-specific questionnaire composed of 13 questions incorporated into 1 multi-item scale designed to evaluate dyspnea and a series of single items assessing different types of pain, as well as, cough, hemoptysis, dysphagia, sore mouth, alopecia, and peripheral neuropathy. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with 100 representing the best possible function/QOL, and highest burden of symptoms for symptom domains and single items. The data is presented as percentage of participants with EORTC module QLQ-C13 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of participants|||Number
34545|NCT01528605|Secondary|Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention|best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 24 weeks, 48 weeks, 2 years during the intervention|||letters||Standard Deviation|Mean
34478|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)|The EORTC QLQ-C30 symptom score, a cancer specific self-reporting questionnaire was composed of 9-symptom scales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All of the multi-item scales and single-item measures ranged in score from 0 to 100. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with a higher scale score representing a higher response level/ high level of symptomatology / problems. The data is presented as percentage of participants with EORTC QLQ-C30 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of participants|||Number
34479|NCT01529112|Secondary|Disease Control Rate (DCR)|The percentage of participants with CR, PR, or stable disease (SD) for greater than or equal to 12 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
34480|NCT01529112|Secondary|Response Duration (RD)|Response duration, defined as the time from the date of the first assessment demonstrating a CR or PR to the date of the first assessment demonstrating progressive disease or death, whichever occurred first. This is an investigator assessed outcome, measured using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response duration was summarized by including only subjects with events. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using subjects with events.||Weeks||95% Confidence Interval|Median
34481|NCT01529112|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death from any cause.|From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||weeks||95% Confidence Interval|Median
34482|NCT01529112|Secondary|Overall Response Rate (ORR)|ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
34483|NCT01529112|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the randomization until the date of first documented disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or date of death from any cause (whichever occurred first), assessed based on investigator's assessment. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until date of first documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||weeks||95% Confidence Interval|Median
34484|NCT01529112|Secondary|1-year Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 1 year and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 1 year|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
34485|NCT01529112|Secondary|6-Month Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 6 months and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 6 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.||Percentage of Participants||95% Confidence Interval|Number
34656|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.|Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)|Day 0 to Week 26|||mm||Standard Error|Least Squares Mean
34486|NCT01529112|Secondary|Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the subject was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, treatment emergent adverse events (TEAEs) (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)|Safety was analyzed in Safety Analysis Set defined as all subjects enrolled and randomized to treatment in study, except for those who (i) dropped out prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.||Participants|||Number
34487|NCT01528969|Secondary|The Changes in the Counts of the 14 Other Bacterial Species|The bacterial species were measured from stimulated saliva at the beginning and after the intervention|5 weeks||||||
34488|NCT01528969|Primary|MS Counts of Stimulated Saliva|The MS counts were measured at the beginning and in the end of the 5 weeks intervention|5 weeks|||MS counts log CFU/ml||Standard Deviation|Mean
34489|NCT01528891|Primary|Diastolic Blood Pressure (DBP)|"mmHg~Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis."|Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Diastolic blood pressure values were compared between groups at each time point and within groups over time.||mmHg||Standard Deviation|Mean
34490|NCT01528891|Primary|Systolic Blood Pressure (SBP)|"mmHg~Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis."|Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Systolic blood pressure values were compared between groups at each time point and within groups over time.||mmHg||Standard Deviation|Mean
34491|NCT01528891|Secondary|Incidence of Emergence Agitation (EA)|Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.|The highest PAED score for each patient within the first 30 minutes after waking up was recorded.|There were 2 patients in the Dexmedetomidine group and 9 patients in the placebo group who were excluded from analysis of emergence agitation. These patients were excluded because they received medications that were not a part of the anesthetic protocol and could affect their PAED score.||percentage of patients with EA|||Number
34492|NCT01528891|Primary|Heart Rate (HR)|beats per minute (bpm)|Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Heart rate values were compared between groups at each time point and within groups over time.||bpm||Standard Deviation|Mean
34493|NCT01528735|Secondary|Predose Measured Concentration of RBV|Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34494|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of RBV|"Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
34495|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,57) of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34496|NCT01528735|Secondary|AUC Accumulation Ratio of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34546|NCT01528605|Secondary|Changes of Serum Xanthophylls Concentrations During the Intervention|Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 4, 12, 24 and 48 weeks during the intervention|||μmol/L||Standard Deviation|Mean
34497|NCT01528735|Secondary|Predose Measured Concentration of CD 6168-AG|Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34498|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168-AG|"Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide.~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
34499|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34500|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34501|NCT01528735|Secondary|Predose Measured Concentration of CD 6168|Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34502|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168|"Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
34503|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34504|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34505|NCT01528735|Secondary|Predose Measured Concentration of BI 208333|Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34506|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of BI 208333|"Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
34558|NCT01528332|Secondary|Vital Sign Parameters|Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups|Baseline (days -7 to -1) to Follow up (up to day +42)||||||
34507|NCT01528735|Secondary|AUC Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34508|NCT01528735|Secondary|Cmax Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34509|NCT01528735|Secondary|Predose Measured Concentration of Faldaprevir|Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34510|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Faldaprevir|Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||mL/min||Geometric Coefficient of Variation|Geometric Mean
34511|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Faldaprevir|"Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||||
34512|NCT01528735|Secondary|AUC Accumulation Ratio of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34513|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34514|NCT01528735|Secondary|Predose Measured Concentration of Deleobuvir|Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34515|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Deleobuvir|Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||Litres per hour||Geometric Coefficient of Variation|Geometric Mean
34516|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Deleobuvir|Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.||hours||Geometric Coefficient of Variation|Geometric Mean
34559|NCT01528332|Secondary|Frequency, Severity, Nature and Duration of Adverse Events During the Whole Duration of the Study|Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.|Baseline (days -7 to -1) to Follow up (up to day +42)||||||
34560|NCT01528332|Secondary|Change From Treatment in RMDQ at Follow up||Treatment (days +1 to +14) to Follow up (up to day +42)||||||
34517|NCT01528735|Secondary|AUC Accumulation Ratio of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34518|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Ratio||Geometric Coefficient of Variation|Geometric Mean
34519|NCT01528735|Secondary|Area Under the Curve (AUC) of RBV|Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
34520|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of RBV|Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
34521|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of RBV|Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34522|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168-AG|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34523|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG|Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
34524|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168-AG|Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34525|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34526|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168|Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
34527|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168|Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34561|NCT01528332|Secondary|Change From Baseline in RMDQ at Follow up||Baseline (days -7 to +1) to Follow-up (up to day +42)||||||
34528|NCT01528735|Secondary|Area Under the Curve (AUC) of BI 208333|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34529|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333|Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
34530|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of BI 208333|Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34531|NCT01528735|Secondary|Area Under the Curve (AUC) of Faldaprevir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
34532|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir|Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
34533|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Faldaprevir|Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34534|NCT01528735|Secondary|Area Under the Curve (AUC) of Deleobuvir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34535|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir|Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
34536|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Deleobuvir|Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34537|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 8|Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8.|8 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load||percentage of participants|||Number
34538|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 4|Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4.|4 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load||percentage of participants|||Number
34539|NCT01528735|Primary|Number of Patients With Drug-related Adverse Events|Number of patients with investigator defined drug-related Adverse Events|From first dose of study medication until 30 days after last dose of study medication, up to 199 days|Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
34540|NCT01528605|Secondary|Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention||at baseline, 24, 48 weeks and 2 years||12/2015||||
34541|NCT01528605|Secondary|Changes From Baseline in Microperimetry (MP) During the Intervention|Microperimetry (MP) was measured by the MP1 Microperimeter|at baseline, 24, 48 weeks and 2 years during the intervention||12/2015||||
34542|NCT01528605|Secondary|Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks||at baseline and 48 weeks during the intervention||12/2015||||
34547|NCT01528605|Primary|Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years|"Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.~4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer."|at baseline and 24 weeks, 48 weeks, 2 years during the intervention|||density units||Standard Deviation|Mean
34548|NCT01528592|Primary|Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.|Correlation coefficient between UPDRS III score and independent components analysis network strength in left parietal cortex. UPDRS III is the Unified Parkinson's Disease Rating Scale composite motor score.|1 hour|||unitless|||Number
34549|NCT01528592|Primary|Efficacy of Parkinson's Medication on Brain Connectivity|Two 25-30 minute MRI scans will be conducted. The first when the patient is OFF PD medications for approximately 12 hours and the second following dosage of PD medication thereby being ON PD medication for the 25-30minute scan. There is an hour between the two scans that the patient will complete a series of cognitive assessments: UPDRS, MOCA, medical history, geriatric depression scale, and family history.|2 and 1/2 hours||||||
34550|NCT01528345|Secondary|Time to Worsening of ECOG Performance Status|Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.)|Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)|This outcome measure was not analyzed as the study was terminated before time to worsening ECOG performance could be analyzed.|||||
34551|NCT01528345|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events.~The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details."|Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months)|Safety Set: Consisted of all patients who received at least one dose of any compound of the study treatment (dovitinib +fulvestrant or placebo+fulvestrant). Patients were analyzed according to the actual study treatment received. Actual treatment received was defined as the treatment the patient received at the first day of study medication.||Participants|||Number
34552|NCT01528345|Secondary|Overall Survival (OS) Using Kaplan- Meier Method|OS was defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.|From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.||Months||95% Confidence Interval|Median
34553|NCT01528345|Secondary|Duration of Response (DOR)|DOR was defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment.|From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months|This outcome measure was not analyzed as the study was terminated before duration of response could be analyzed.|||||
34554|NCT01528345|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.||Percentage of participants||95% Confidence Interval|Number
34555|NCT01528345|Primary|Progression Free Survival (PFS) Based on Local Investigator Assessment|PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they wereassigned at randomization.||Months||95% Confidence Interval|Median
34556|NCT01528332|Secondary|Average Visual Analog Scale Pain Relief Over 5 Treatments|The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief|5 treatments (days +1 to +14)||||||
34557|NCT01528332|Secondary|Changes From Baseline in Skin Condition|Skin condition (erythema and hyperpigmentation as measured with the MX-18) and appearance (recorded with Polaroid photos) will be assessed once each at baseline and follow up, and before and after each treatment. The changes from baseline will be analysed using descriptive statistics and the two treatment arms compared.|Baseline (days -7 to -1) to Follow up (up to day +42)||||||
34562|NCT01528332|Secondary|Change From Treatment in VAS Pain Intensity at Follow up||Treatment (day +1 to +14) to Follow-up (up to day +42)||||||
34565|NCT01528332|Primary|Change From Baseline (Mean of Three Measurements at Screening, Prior to Treatment Visit 1 and Treatment Visit 1 Pretreatment) in the Average Visual Analog Scale (VAS) Pain Intensity Over the 5 Treatment Days|Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable|Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)|||cm||Standard Error|Mean
34566|NCT01528319|Secondary|Adverse Event Evaluation|To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery|Between the time of obtainment of consent and 24 weeks after surgery|||participants|||Number
34567|NCT01528319|Secondary|Number of Participants With Abnormal Changes in One or More Laboratory Tests|To evaluate changes over time in each laboratory test item from before surgery to 12 and 24 weeks after surgery regarding the presence or absence of abnormal changes, causal relationship with this product and causes for development|12 weeks and 24 weeks after surgery|||participants|||Number
34568|NCT01528319|Secondary|Clinical Function Evaluation|"To evaluate the JSS-SIS score and Rowe score at 24 weeks after surgery~JSS-SIS Score (subscales are summed, higher values represent a better outcome):~Pain (0 to 20)~Function (0 to 20)~Range of Motion (0 to 20)~Evaluation of X-ray findings (0 to 10)~Stability (0 to 30)~Rowe Score (subscales are summed, higher values represent a better outcome):~Stability (0 to 50)~Motion (0 to 20)~Function (0 to 30)"|24 weeks|||units on a scale||Standard Deviation|Mean
34569|NCT01528319|Secondary|Procedure Success|The rate of successful cases when procedure success was defined as “The anchors can be inserted into the burr holes without breakage and the glenohumeral ligament labral complex can be sutured without tear of the sutures”|12 weeks|||participants|||Number
34570|NCT01528319|Primary|Clinical Function Evaluation|"To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery~JSS-SIS Score (subscales are summed, higher values represent a better outcome):~Pain (0 to 20)~Function (0 to 20)~Range of Motion (0 to 20)~Evaluation of X-ray findings (0 to 10)~Stability (0 to 30)~Rowe Score (subscales are summed, higher values represent a better outcome):~Stability (0 to 50)~Motion (0 to 20)~Function (0 to 30)"|12 weeks|||units on a scale||Standard Deviation|Mean
34571|NCT01528319|Primary|Surgery Success|The rate of successful cases when surgery success is defined as “Procedure success is confirmed, the anchors are confirmed to be in the burr holes by the MRI examination, the glenohumeral ligament labral complex is maintained at the anterior edge of the glenoid cavity at 12 weeks after surgery, and there is no need of retreatment”|12 weeks after surgery|||participants|||Number
34572|NCT01528293|Secondary|Degree of Take|Degree of split thickness skin graft taken or bioengineered alternative tissue induced wound shrinkage after 6 weeks of ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 Weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
34573|NCT01528293|Secondary|Quality of Life|Quality of life between ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
34574|NCT01528293|Secondary|Compare the Time to Wound Bed Preparation, Quality of Life, Degree of Split Thickness Skin Graft/Bio-engineered Alternative Tissue Take|-Compare the time to wound bed preparation between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
34575|NCT01528293|Primary|Compare Wound Healing|Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.|||||
34576|NCT01528215|Primary|Marginal Bone Level|Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value denotes gain of bone. Negative value denotes loss of bone.|12 months after implant loading|||Millimeter|Participants|Standard Deviation|Mean
34577|NCT01528150|Primary|Freedom From RA and RV Lead-related Complications|Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.|up to 12 months post-implant|A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.||percentage of participants||97.5% Confidence Interval|Number
34578|NCT01527942|Secondary|Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.|The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.|24 hours after baseline|Study was terminated - data were determined to be unusable by IRB due to consent issues.|||||
34579|NCT01527942|Secondary|Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours|The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.|||||
34580|NCT01527942|Primary|Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours|The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.|||||
34581|NCT01527513|Secondary|Change From Baseline in Seizure Frequency During the One-year Open-Label (OL)|Overall Change from Baseline in Seizure Frequency per week for the One-Year Open-Label Period|Weeks 1 to ≥ 41 weeks|Modified Efficacy Intent-to-Treat (ITT) population– all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||Seizure per week||Standard Error|Mean
34583|NCT01527513|Primary|Change From Baseline in Power of Attention Score to the End of the Double Blind (DB) Period|Power of Attention was defined as the sum of the reaction time measures from the attentional tasks (simple [dominant hand only] reaction time, choice reaction time and digit vigilance speed) in order to assess information processing speed and attention/psychomotor speed.Change from baseline to the end of the double-blind period in Power of Attention will be compared between the treatment groups using an ANCOVA. Non-inferiority of ESL vs Placebo will be assessed by comparing the 95% CI’s upper bound of the difference of Least Squares Mean (LSmeans) between treatment groups (ESL-placebo) with 121 ms. If the upper bound is greater than 121 ms then the null hypothesis that the change from baseline in the Power of Attention score in ESL group is at least 121 ms inferior than the placebo group will be rejected. Single Values were calculated the average of post treatment visits (visits 5 and 7or EDV) minus average of baseline visits (visits 1 and 2)|Visit 1 (-4 weeks for training), Visit 2 (Day 1), Visit 5 (6 weeks), Visit 7 (12 weeks) or at early discontinuation visit (EDV)|The primary analysis was based on the Cognitive Per-protocol (PP) population – all patients in the Modified Cognitive Intent-to-Treat (ITT) population who completed the 8-week maintenance period and were not Important Protocol Deviations (IPDs) with respect to the primary cognitive endpoint.||Milli seconds (ms)||Standard Error|Mean
34584|NCT01527487|Secondary|Disease-Free Survival (DFS) at 2 Years|Defined as the percent probability that participants had not experienced disease recurrence or died from any cause at 2 years post-surgery, analyzed by Kaplan-Meier methodology.|24 months|Includes all patients that completed surgery.||percent probability of survival||95% Confidence Interval|Number
34585|NCT01527487|Secondary|Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy|Defined as the number of patients with a best response of clinical complete or partial response (cCR or cPR) divided by the number of patients qualified for tumor response analysis per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI or CT. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD;|43 months|All patients evaluated/evaluable per RECIST v1.1||percentage of participants|||Number
34586|NCT01527487|Secondary|The Number of Adverse Events as a Measure of Safety and Tolerability.|Treatment-Related Adverse Events occurring in >= 15% of treated patients|43 months|||participants|||Number
34587|NCT01527487|Primary|Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery|One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist.|18 weeks|Patients who completed 6 cycles and proceeded to surgery.||percentage of surgical patients|||Number
34588|NCT01527370|Primary|Number of Participants With Serious Adverse Events|"A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to 42 days postvaccination|This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.||Participants|||Number
34589|NCT01527370|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination|GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.||Ratio||95% Confidence Interval|Geometric Mean
34590|NCT01527370|Primary|The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination|Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
34591|NCT01527162|Secondary|Assessment of Life Habits for Children (LIFE-H)|Participation in habits of daily life will be by parental report of the Life Habits questionnaire(Life-H for children) by the weighted total score on a scale of 0 to 9, with a higher score representing more participation in habits of daily life.|previous 7 day reference|||units on a scale||Standard Deviation|Mean
34592|NCT01527162|Secondary|Physical Activity Scale for Kids - Performance Version (ASKp)|Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey- total score. Scale ranges from 0 to 100 with higher scores representing more physical activity. A score of 100 on this criterion referenced evalutive measure is consistent with physical activity like that of a typically developing 5 year old.|previous 7 day reference|||units on a scale||Standard Deviation|Mean
34593|NCT01527162|Primary|Walking Activity Levels|Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.|average of 5 days of second week of intervention|||average total strides/day||Standard Deviation|Mean
34594|NCT01527006|Secondary|The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at planned visit and at EOT (the duration after the day of first study drug dose up to 7 days after the Extension Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to the planned/EOT visits compared to Baseline (Week 0).|Week 0 (Baseline), Week 11, Week 28, Week 52 or EOT|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Participants|||Number
34595|NCT01527006|Secondary|Seizure-free Rate During the Overall Treatment Duration [Extension Phase]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. The percentage of participants who were seizure free was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as the percentage of participants.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Percentage of participants|||Number
34596|NCT01527006|Secondary|50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the overall treatment duration. The percentage of responders was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as percentage of responders.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Percentage of responders|||Number
34597|NCT01527006|Secondary|Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.||Percent change||Full Range|Median
34598|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
34599|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
34600|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
34601|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
34602|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
34603|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.|||||
34604|NCT01527006|Secondary|Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the three options (yes, no and don't mind).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
34605|NCT01527006|Primary|Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]|C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F [L/h]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation.|From Day 8 up to Day 78|The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.||ng/mL||Standard Deviation|Mean
34606|NCT01527006|Secondary|Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
34607|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
34608|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.||Participants|||Number
34609|NCT01527006|Secondary|Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results.|For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase|The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.||Participants|||Number
34610|NCT01527006|Secondary|The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0).|Week 0 (Baseline), Week 11 or EOT|The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Participants|||Number
34611|NCT01527006|Secondary|Seizure-free Rate During the Maintenance Period [Core Study]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization.|Week 9 to Week 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Percentage of participants|||Number
34612|NCT01527006|Secondary|50% Responder Rate During the Maintenance Period-LOCF [Core Study]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Percent responders|||Number
34613|NCT01527006|Primary|Apparent Clearance (CL/F) of Perampanel [Core Study]|CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation.|From Day 8 up to Day 78|The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.||Liter per hour||Standard Deviation|Mean
34614|NCT01527006|Secondary|Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.||Percent change||Full Range|Median
34615|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Near Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol||units on a scale||Standard Deviation|Mean
34616|NCT01526902|Primary|Objective Vision Assessments: High Contrast Near Visual Acuity|Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol||logMAR units||Standard Deviation|Mean
34657|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .|Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis|Day 0 to Week 26|||Ratio||Standard Error|Least Squares Mean
34617|NCT01526902|Primary|Objective Vision Assessments: High Contrast Intermediate Visual Acuity|Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol||logMAR units||Standard Deviation|Mean
34618|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Intermediate Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol||units on a scale||Standard Deviation|Mean
34619|NCT01526902|Secondary|Subjective Overall Vision: High Contrast Distance Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol||units on a scale||Standard Deviation|Mean
34620|NCT01526902|Primary|Objective Vision Assessments: High Contrast Distance Visual Acuity|Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol||logMAR units||Standard Deviation|Mean
34621|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.||percent predicted FVC||Standard Deviation|Mean
34622|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.||percent predicted FVC||Standard Deviation|Mean
34623|NCT01526785|Secondary|Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52|GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale.The score for each dimension was expressed as a percentage of the maximum score for that dimension.Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 GMFM-88 data.||percentage of total score||Standard Deviation|Mean
34624|NCT01526785|Secondary|Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.||Z score||Standard Deviation|Mean
34625|NCT01526785|Secondary|Invasive Ventilator-Free Survival Rate at Week 52|Percentage of participants, who were invasive ventilator-free at week 52, are reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.||percentage of participants||95% Confidence Interval|Number
34626|NCT01526785|Secondary|Survival Rate at Week 52|Percentage of participants who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population.||percentage of participants||95% Confidence Interval|Number
34627|NCT01526785|Primary|Percentage of Participants Who Were Clinically Stable or Improved at Week 52|Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.||percentage of participants||95% Confidence Interval|Number
34628|NCT01526733|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360])|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]). Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable AUMC(0-360)/AUC(0-360) data.||ratio||Standard Deviation|Mean
34629|NCT01526733|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360])|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose Days 1 and 4|Participants who completed both phases of the study and with evaluable AUC(0-360) data.||picomoles*minutes/liter||Standard Deviation|Mean
34630|NCT01526733|Secondary|Time to 50% Total Glucose Infused (50%Gtot)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable 50%Gtot data.||minutes||Standard Deviation|Mean
34631|NCT01526733|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)|Early and late tGIR50%max are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable early and late tGIR50%max data.||minutes||Standard Deviation|Mean
34632|NCT01526733|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable tGIRmax data.||minutes||Standard Deviation|Mean
34633|NCT01526733|Secondary|Maximum Glucose Infusion Rate (GIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable GIRmax data.||milligrams/kilogram/minute||Standard Deviation|Mean
34634|NCT01526733|Primary|Early Insulin Exposure (%AUC[0-60])|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0 360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 60 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable %AUC(0-60) data.||percentage of AUC(0-60)||Standard Deviation|Mean
34635|NCT01526551|Primary|Number of Students Who Completed HPV Vaccination as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program|August 2012 -- June 2013|||participants|||Number
34636|NCT01526551|Primary|Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program|August 2012-June 2013|||participants|||Number
34637|NCT01526538|Secondary|Learning Task by Itami and Uno||At the baseline laboratory visit|||% correct||Standard Error|Mean
34638|NCT01526538|Primary|Medication Side-effects|self-report of medication side effects (Units of Measure is the count of specific reported effects)|1 month post-treatment.|||Adverse event reports|||Number
34639|NCT01526538|Primary|Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)|The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results|1 month post-treatment|||ng/ml||Standard Deviation|Mean
34640|NCT01526213|Primary|Primary Pharmacokinetic Measure: Area Under the Curve (AUC)||0-72 hours|||micromolar*hr||Full Range|Geometric Mean
34641|NCT01526148|Secondary|Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)|Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.|Screening and Week 16|||IR Score||Standard Deviation|Mean
34642|NCT01526148|Primary|Time to Study Discontinuation|The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure|Week 16|||days||95% Confidence Interval|Mean
34643|NCT01525927|Secondary|Identify Additional Toxicity of Treatment|To identify additional toxicity of treatment|During therapy and up to 5 years following completion of treatment||||||
34644|NCT01525927|Secondary|Assessment of Quality of Life Outcomes|Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function.|Baseline, during therapy and up to two years following completion of radiation phase||||||
34645|NCT01525927|Secondary|Assess Distant Disease Control at 2 Years.|3.5 To assess distant disease control at 2 years.|At two years following completion of radiation phase||||||
34646|NCT01525927|Secondary|Assess Locoregional Disease Control at 2 Years|To assess locoregional disease control at 2 years|At two years following completion of radiation phase||||||
34647|NCT01525927|Secondary|Assess Overall Survival at 2 Years.|To assess overall survival at 2 years.|At two years following completion of radiation phase||||||
34648|NCT01525927|Secondary|Progression-free Survival at 2 Years|assess Progression-free survival at 2 years.|At two years following completion of radiation phase||||||
34649|NCT01525927|Secondary|To Define Objective Tumor Response Rates to Induction Chemotherapy and to Subsequent Radiation-based Treatment.|To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria.|Three months following completion of radiation therapy phase.||||||
34650|NCT01525927|Primary|Response (CR+PR) Status at 3 Months Post-therapy|"The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5).~Zero (0) participants analyzed"|3 months following completion of radiation phase|No study intervention or data collected.|||||
34651|NCT01525745|Secondary|Survival|Progrsesion Free and Overall Survival|2 years|data not collected, therefore no analysis done|||||
34652|NCT01525745|Secondary|Long Term Effects of Image-guided Radiosurgery/SBRT|Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord|2 years|data not collected, therefore no analysis done|||||
34653|NCT01525745|Secondary|Quality of Life|Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D|2 years|data not collected, therefore no analysis done|||||
34654|NCT01525745|Secondary|Duration of Pain Response|Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy|2 years|data not collected, therefore no analysis done|||||
34655|NCT01525745|Primary|Pain Control as Measured by NPRS|Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy|2 years|study was terminated by the local IRB due to slow accrual. 1 participant withdrew consent and 1 participant did not complete the assigned arm treatment per protocol and then removed from study. left with 4 participants and data were not collected for any participants therefore no analysis has been done.|||||
34660|NCT01525667|Primary|Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.|Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.|Day 0 to Week 26|||Newtons||Standard Error|Least Squares Mean
34661|NCT01525641|Secondary|Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA|Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.|Week 52|Patients in safety set and with concomitant L-DOPA||participants|||Number
34662|NCT01525641|Secondary|Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA|"Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off."|Week 52|Patients in safety set and with concomitant L-DOPA.||participants|||Number
34663|NCT01525641|Secondary|Change From Baseline in the Modified Hoehn & Yahr to Last Observation|Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.|Baseline and week 52|Efficacy set||Units on a scale||Standard Deviation|Mean
34664|NCT01525641|Secondary|Change From Baseline in Total Score of the UPDRS Part III to Last Observation|"Change from baseline at the last observation in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III total score.~UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient’s physical status.~The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.~The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia."|Baseline and week 52|Efficacy set||units on a scale||Standard Deviation|Mean
34665|NCT01525641|Secondary|Clinical Global Impression of Effect|Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.|Week 52|Efficacy set: included all patients in the “safety set” except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease||participants|||Number
34666|NCT01525641|Primary|Percentage of Adverse Drug Reactions|Percentage of subjects with adverse drug reactions|From baseline up to week 52|Safety set||percentage of participants|||Number
34667|NCT01525628|Secondary|Number of Participants With Sustained Virological Response (SVR12)|Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.|12 weeks post treatment|Treated set (TRT): This subject set includes all patients who were dispensed trial medication and were documented to have taken at least one dose of trial drug.||Participants|||Number
34668|NCT01525628|Primary|AUC 0-12hr of Raltegravir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
34669|NCT01525628|Primary|C12hr of Raltegravir|Concentration of an analyte in plasma at 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
34670|NCT01525628|Primary|Cmax of Raltegravir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
34671|NCT01525628|Primary|AUC 0-24hr of Tenofovir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
34672|NCT01525628|Primary|C24hr of Tenofovir|Concentration of an analyte in plasma at 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
34673|NCT01525628|Primary|Cmax of Tenofovir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.|||||
34674|NCT01525628|Primary|AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34675|NCT01525628|Primary|Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34676|NCT01525628|Primary|AUC 0-infinity of Midazolam|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34677|NCT01525628|Primary|Cmax of Midazolam|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34678|NCT01525628|Primary|AUC 0-infinity of Tolbutamide|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34679|NCT01525628|Primary|Cmax of Tolbutamide|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34680|NCT01525628|Primary|AUC 0-infinity of Caffeine|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
34681|NCT01525628|Primary|Cmax of Caffeine|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34682|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34683|NCT01525628|Primary|C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34684|NCT01525628|Primary|Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34685|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34686|NCT01525628|Primary|C6hr of Deleobuvir Reduction Metabolite CD 6168|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34687|NCT01525628|Primary|Cmax of Deleobuvir Reduction Metabolite CD 6168|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34688|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34689|NCT01525628|Primary|C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34690|NCT01525628|Primary|Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34691|NCT01525628|Primary|AUC 0-6hr of Deleobuvir (BI 207127)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
34692|NCT01525628|Primary|C6hr of Deleobuvir (BI 207127)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34693|NCT01525628|Primary|Cmax of Deleobuvir (BI 207127)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
34694|NCT01525628|Primary|Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
34695|NCT01525628|Primary|C24hr of Faldaprevir (BI 201335)|Concentration of an analyte in plasma at 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34696|NCT01525628|Primary|Cmax of Faldaprevir (BI 201335)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34697|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 12 weeks of treatment|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
34809|NCT01523756|Primary|Leakage Under the Base Plate Using a 24-point Scale|Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)|Each product will be tested 2 weeks|||units on a scale|Participants|Standard Deviation|Mean
34698|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 6 weeks of treatment|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
34699|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed on day 1|1 day|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
34700|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||units / seconds||Standard Error|Least Squares Mean
34701|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||units / seconds||Standard Error|Least Squares Mean
34702|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 1 day of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates slowing down in decline in breathing, i.e., favorable results."|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.||units / seconds||Standard Error|Least Squares Mean
34703|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 6 weeks of treatment.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
34704|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) on Day 1.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.||liters||Standard Error|Least Squares Mean
34705|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||seconds||Standard Error|Least Squares Mean
34706|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity on Day 1. Analysis of covariance model on log10 transformation data. Adjusted means are back transformed to report in original units. Standard errors (SEs) are calculated using the delta method.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.||seconds||Standard Error|Least Squares Mean
34767|NCT01524796|Secondary|Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Participants|||Number
34707|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 12 weeks of treatment.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||liters||Standard Error|Least Squares Mean
34708|NCT01525615|Secondary|Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks|Key secondary endpoint was endurance time during endurance shuttle walk test to symptom limitation at 85% of predicted maximum oxygen consumption (VO2) peak after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Endurance shuttle walk test (ESWT) substudy set - This patient set included all patients in the Treated Set who had given informed consent for participating in the ESWT substudy and had a baseline and at least one post-baseline measurement during ESWT before or at Week 12 for the key secondary endpoint.||seconds||Standard Error|Least Squares Mean
34709|NCT01525615|Primary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks|Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.||seconds||Standard Error|Least Squares Mean
34710|NCT01525563|Secondary|Overall Clinical Response|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.|6 months|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.||participants|||Number
34711|NCT01525563|Secondary|Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment|To observe the evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.|6 months|To observe the evolution of duration of menstrual bleeding from baseline (all enrolled) to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment (EOT).||Days||Standard Deviation|Mean
34712|NCT01525563|Secondary|Overall Patient Satisfaction|The overall patient satisfaction was recorded on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied).|6 months|Overall at the EOT, of 910 patients population the overall satisfaction was assessed||participants|||Number
34713|NCT01525563|Secondary|Evolution of Pain During Menstruation From Baseline to End of Treatment|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline and end of treatment where 0 means no pain, and 10 means worst pain.|6 months|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline for all enrolled subjects and end of treatment where 0 means no pain, and 10 means worst pain.||participants|||Number
34714|NCT01525563|Secondary|Amount of Menstrual Bleeding From Baseline to End of Treatment|Assessment of average number of pads changed per day at baseline and at the end of treatment (EOT).|6 months|The amount of menstrual bleeding (based on no. of pads used per day) was analyzed for all subjects completing EOT and change was noted from baseline to EOT||pads/day||Standard Deviation|Mean
34715|NCT01525563|Secondary|Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT)|The evolution of cycle duration from baseline to EOT was assessed by mean cycle duration (in days) at baseline, separately in polymenorrhea and oligomenorrhea groups, and at the EOT. The patients were included in polymenorrhea group in case the cycle duration at baseline was less than 21 days and in oligomenorrhea group in case the cycle duration at baseline was greater than 35 days.|6 months|All patients were assessed for overall reduction in cycle duration (910).||Days||Standard Deviation|Mean
34716|NCT01525563|Primary|Percentage of Patients Reporting a Regular Cycle|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.|6 months|Intent-to-Treat Population||percentage of participants||95% Confidence Interval|Number
34717|NCT01525420|Secondary|7-day and 24-hour Point Prevalence Quit Rates|7-day and 24-hour point prevalence quit rates|6-month||||||
34718|NCT01525420|Primary|Number of Participants Who Stopped Smoking by 6 Month Post Treatment|30-Day point prevalence abstinence at 6 months post treatment|6 months|||participants|||Number
34719|NCT01525238|Secondary|Number of Participants With Marked Urinalysis Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Blood, urine (Qualitative): >=2 (If Pre-Rx >= 1, >=2*Pre-Rx). Glucose, urine (Qualitative): >=1, (If Pre-Rx >=1, >=2*Pre-Rx). Protein, urine (Qualitative): >=2 (If Pre-Rx >=1, >=2*Pre-Rx). Red Blood Cells (RBC), urine (RBC per High Power Field (hpf)): >=2 (If Pre-Rx>=2, >=4).~White Blood Cells (WBC), urine (hpf): >=2 (If Pre-Rx>=2, >=4)."|Day 1 (Pre-dose) to Day 3|All treated participants with evaluable lab results||participants|||Number
34805|NCT01523873|Secondary|Diagnostic Quality|"Diagnostic quality was assessed by the radiologist by answering the question could you come to a diagnostic ? (answer : yes or no)."|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 308 patients.||participants|||Number
34720|NCT01525238|Secondary|Number of Participants With Marked Abnormalities in Other Chemistry Testing|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Glucose, fasting serum (mmol/L): <0.8*LLN, >1.3*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN).~Protein (grams per deciliter: g/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN:~>1.1*Pre-Rx, <LLN). Albumin (g/L): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mmol/L): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx).~Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)"|Day 1 (Pre-dose) to Day 3|All treated participants||participants|||Number
34721|NCT01525238|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L):~>1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).~Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (micromoles per Liter (umol/L)): >1.5*ULN if Pre-Rx missing or <= ULN, >1.33*Pre-Rx if PreRx > ULN. Sodium (mmol/L): >1.05*ULN, 1.05*Pre-Rx if Pre-Rx>ULN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN). Potassium(mmol/L), Chloride (mmol/L), Calcium(mmol/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN)."|Day 1 (Pre-dose) to Day 3|All treated participants||participants|||Number
34722|NCT01525238|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose (Day -1). Lab values that met the following criteria were marked as abnormalities:~Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (x10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx).~Leukocytes (x10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre- Rx>ULN, use >1.15*Pre-Rx or <LLN). Neutrophils (Absolute) (x10^3 c/uL): <=1.5. Lymphocytes (Absolute) (x10^3 c/uL): <0.75 or >7.5. Monocytes (Absolute) (x10^3 c/uL): >2.000. Basophils (x10^3 c/uL): >0.4. Eosinophils (Absolute) (x10^3 c/uL): >0.75. Blasts (Absolute) (x10^9 c/L) > 0."|Day 1 (Pre-dose) to Day 3|All treated participants||participants|||Number
34723|NCT01525238|Secondary|Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.|Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported.|Day 1 to Day 3|All treated participants||participants|||Number
34724|NCT01525238|Secondary|Mean Total Amount of Glucose Excreted in Urine Over 24 Hours|The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams.|Time of dose to 24 hours post-dose, Day 1 to Day 2|All treated participants with evaluable PD profiles||grams||Standard Deviation|Mean
34725|NCT01525238|Secondary|Mean Change in Fasting Plasma Glucose From Baseline Until Day 2|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable PD profiles||mg/dL||Standard Deviation|Mean
34726|NCT01525238|Secondary|Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable pharmacodynamic (PD) profiles||mg/dL||Standard Deviation|Mean
34727|NCT01525238|Secondary|Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||hours||Standard Deviation|Mean
34728|NCT01525238|Secondary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
34729|NCT01525238|Secondary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
34730|NCT01525238|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin 3-O-Glucuronide was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||hours||Full Range|Median
34731|NCT01525238|Secondary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34806|NCT01523873|Secondary|Image Quality|Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 164 patients.||participants|||Number
34732|NCT01525238|Primary|Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin|Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||Liters||Geometric Coefficient of Variation|Geometric Mean
34733|NCT01525238|Primary|Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin|Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||mL/min||Geometric Coefficient of Variation|Geometric Mean
34734|NCT01525238|Primary|Mean Plasma Half-life (T-HALF) of Dapagliflozin|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||hours||Standard Deviation|Mean
34735|NCT01525238|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
34736|NCT01525238|Primary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
34737|NCT01525238|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles.||hours||Full Range|Median
34738|NCT01525238|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable pharmacokinetic (PK) profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
34739|NCT01525225|Secondary|Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities|Lower limit of normal (LLN); upper limit of normal (ULN); treatment (RX); pre-treatment (Pre-Rx); units per liter (U/L); millimoles per liter (mmol/L). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-RX >ULN or >1.25*ULN if Pre-RX <=ULN; aspartate aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;alanine aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;blood urea nitrogen mmol/L: >1.1*ULN if Pre-RX <=ULN or >1.2*Pre-RX if Pre-RX >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-RX <=ULN or >1.25*Pre-RX if Pre-RX >ULN; creatine phosphokinase U/L: >1.5*Pre-RX if Pre-RX>ULN or >1.5*ULN if Pre-RX <= ULN. Grams per liter (g/L); cells per liter (c/L). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (%): <0.85*pre-RX;erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN.|Day 1 to Day 8|Participants who received at least one dose of study drug.||participants|||Number
34740|NCT01525225|Primary|Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 up to Day 8, plus 30 days|All participants who received at least one dose of study drug.||participants|||Number
34741|NCT01525173|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Per protocol population included all qualified participants who completed three months of treatment.||mm Hg||Standard Deviation|Mean
34742|NCT01524900|Primary|Number of Patients Reporting Hepatic Events|Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.|up to 72 weeks|||participants|||Number
34743|NCT01524900|Primary|Number of Patients Reporting Rash of Any Severity|Number of patients reporting rash of any severity as adverse event|up to 72 weeks|Patients TS||participants|||Number
34744|NCT01524900|Secondary|Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation|The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.|24 weeks|Patients from FAS||participants|||Number
34807|NCT01523873|Secondary|Nephrogenic Systemic Fibrosis Incidence|For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.|Follow-up of at least 3 months after magnetic resonance examination|Patients of the Safety Population with moderate to severe impaired renal function.||participants|||Number
34745|NCT01524900|Secondary|Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks|The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|baseline and week 24|Patients from FAS with documented MMAS-8 score at baseline and after 24 weeks.||units on a scale||Standard Deviation|Mean
34746|NCT01524900|Secondary|Change in CD4+ Cell Count From Baseline to Week 24|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.|baseline and week 24|Patients from FAS with documented CD4+ at baseline and after 24 weeks.||cells/mm^3||Standard Deviation|Mean
34747|NCT01524900|Secondary|Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)|Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of < 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.|24 weeks|Patients from the Full analysis set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.||participants|||Number
34748|NCT01524900|Primary|Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation|The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.|up to 72 weeks|Patients from TS.||participants|||Number
34749|NCT01524887|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE||Throughout infusions, approximately 2-5 hours|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||infusions|Participants||Number
34750|NCT01524887|Secondary|Number of Infusions Causally Associated With AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||infusions|Participants||Number
34751|NCT01524887|Secondary|Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion||During or within 7 days of completion of an infusion|||infusions|Participants||Number
34752|NCT01524887|Secondary|Number of Infusions Temporally Associated With AEs and/or SAEs|A temporal association was defined as an AE and/or SAE occurring during or within 72 hours of completion of an infusion, regardless of causality.|During or within 72 hours of completion of an infusion|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||infusions|Participants||Number
34753|NCT01524887|Secondary|Number of Participants Experiencing Any AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||participants|||Number
34754|NCT01524887|Secondary|Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.||participants|||Number
34755|NCT01524887|Secondary|Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)|The IADCQ is a 12-item validated questionnaire that has been developed to measure the emotional, physical, and social impact of care giving on AD caregivers. Higher scores on the IADCQ are associated with a higher impact. IADCQ total score range: 0 (no impact) - 48 (greatest impact). Each item can be scored either 0 (Not at all), 1 (A little), 2 (Somewhat), 3 (A lot), or 4 (Extremely). As this is a 12-item scale, the minimum possible score is 0 and the maximum possible score is 4x12 = 48.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
34756|NCT01524887|Secondary|Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant´s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52, with lower scores associated with a lower quality of life.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
34757|NCT01524887|Secondary|Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement||Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||mm^3||Standard Deviation|Mean
34758|NCT01524887|Secondary|Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 10 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
34759|NCT01524887|Secondary|ADCS-Clinical Global Impression of Change (CGIC) at 18 Months|The ADCS-CGIC is a validated categorical measure of change in a participant’s global clinical status between baseline and follow-up visits, based on interview of the participant and the caregiver by a skilled and experienced clinician who was blinded to treatment assignment. The ADCS-CGIC score is based on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||95% Confidence Interval|Least Squares Mean
34760|NCT01524887|Primary|Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
34761|NCT01524887|Primary|Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.||Scores on a scale||Standard Deviation|Mean
34762|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|After Baseline, Month 1, 2, 3 visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.||Participants|Participants||Number
34763|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|Before Baseline, Month 1, 2, 3 Visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.||Participants|Participants||Number
34764|NCT01524796|Secondary|Pregabalin Dose|"Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.||Milligram (mg) per day||Standard Deviation|Mean
34765|NCT01524796|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire|"WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.||Units on a scale||Standard Deviation|Mean
34766|NCT01524796|Secondary|Health-related Quality of Life Scale Score|"Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant’s health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.||Units on a scale||Standard Deviation|Mean
34768|NCT01524796|Secondary|Sleep Interference Scale Score|"Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated “pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3, Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.||Units on a scale||Standard Deviation|Mean
34769|NCT01524796|Primary|Change From Baseline In Least Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Units on a scale||Standard Deviation|Mean
34770|NCT01524796|Primary|Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Units on a scale||Standard Deviation|Mean
34771|NCT01524796|Primary|Change From Baseline In Average Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.||Units on a scale||Standard Deviation|Mean
34772|NCT01524783|Secondary|Pharmacokinetics (PK)|A single blood sample to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin).|Visit 3 (Cycle 2, Study Day 29)||||||
34773|NCT01524783|Secondary|Time to Definitive Deterioration in WHO Performance Status Change During the Study|The estimated average duration is at least 5-8.5 months until disease progression. WHO Performance Status is a scale rated from 0 (normal) to 5 (dead) by a healthcare professional to assess the overall status of a patient. Deterioration is defined as an increase of at least one category compared to baseline.|Every visit up from randomization to 5 years||||||
34774|NCT01524783|Secondary|Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study|The estimated average treatment duration is at least 5-8.5 months until disease progression. CgA and NSE are potential biomarkers for tumor response. Change from baseline will be noted and correlated with tumor response.|Every visit from baseline up to 5 years||||||
34775|NCT01524783|Secondary|Disease Control Rate (DCR)|The estimated average treatment duration is at least 5-8.5 months until disease progression. DCR will be assessed per modified RECIST 1.0. DCR is the proportion of patients with best overall response of CR, PR or stable disease (SD).|5 years||||||
34776|NCT01524783|Secondary|Objective Response Rate (ORR)|ORR will be assessed per modified RECIST 1.0. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR).|Every Visit from randomization up to 5 years||||||
34777|NCT01524783|Secondary|FACT-G Total Score Over the Duration of the Study|FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions, scored 0 to 4, examining physical, social/family, emotional, and functional well-being. Deterioration is defined as a decrease by at least 7 points compared to baseline.|Every Visit from randomization up to 5 years||||||
34778|NCT01524783|Secondary|Overall Safety Evaluation of Everolimus Versus Placebo|The assessment of safety will be based mainly on the frequency and type of treatment emergent adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. vital signs) will be considered as appropriate. Safety events will be graded using the CTCAE V4.03 (Common Terminology Criteria for Adverse Events).|Every visit from randomization up to 5 years||||||
34779|NCT01524783|Secondary|Overall Survival (OS) Using Kaplan-Meier|OS is defined as the time from the date of randomization to date of death due to any cause.|Every visit from randomization up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.||Percentage of participants||95% Confidence Interval|Number
34780|NCT01524783|Primary|Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier|PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by cat scan (CT) and/or magnetic resonance imaging (MRI).|From date of randomization to progression or death up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.||Percentage of participants||95% Confidence Interval|Number
34781|NCT01524770|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide with evaluable concentration-time data.||hours||Full Range|Median
34782|NCT01524770|Primary|Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
34783|NCT01524770|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.||nanograms times hours per milliliters||Geometric Coefficient of Variation|Geometric Mean
34808|NCT01523873|Primary|Frequency of Adverse Events|Adverse Events were notified and described.|During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).|||Adverse Events|||Number
35080|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Group C|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.||log10 IU/mL||Standard Deviation|Mean
34784|NCT01524302|Primary|Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).~These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively."|2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug|||Log inhibition|||Number
34785|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.|To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||mg*hr/L||Standard Deviation|Mean
34786|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||hours||Standard Deviation|Mean
34787|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||liters per hour||Standard Deviation|Mean
34788|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion|||Liters||Standard Deviation|Mean
34789|NCT01524198|Secondary|Change in Asthma Score From Baseline as Compared to the Score at Disposition|A negative change of asthma score from baseline measurement to measurement at disposition, which could be at 2, 3, or 4 hours time points would indicate a decrese in asthma severity. The asthma score ranged between 5 and 15 points as in the protocol, where 5 is the mildest and 15 is the most severe.|2, 3, or 4 hours from baseline|||units on asthma score||Standard Deviation|Mean
34790|NCT01524198|Primary|Patients Hospitalization Rate|The number of patients hospitalized over the study period (17 months).|17 months|||participants|||Number
34791|NCT01523964|Primary|Number of Subjects With an Adverse Event.|Adverse events will be assessed during the time the subject is enrolled in the trial.|1 day|||participants|||Number
34792|NCT01523886|Secondary|Anti-emetics|Use of anti-emetics during the first 24 hours after surgery|During the first 24 hours after surgery||||||
34793|NCT01523886|Secondary|Nausea and Vomiting|The incidence of nausea and vomiting during the first 24 hours after surgery|The first 24 hours after surgery||||||
34794|NCT01523886|Secondary|Consumption of Analgesics|Consumption of analgesics during the first 24 hours after surgery|The first 24 hours after surgery||||||
34795|NCT01523886|Secondary|Duration of Anesthesia|Duration of anesthesia|From induction of anesthesia to patient ready to leave the operating theatre||||||
34796|NCT01523886|Secondary|Duration of Surgery|Duration of surgery|From surgical incision to last suture has been placed.||||||
34797|NCT01523886|Secondary|Surgical Procedures at Low Pneumoperitoneum|Number of procedures which can be done with pneumoperitoneum 8 mmHg|From surgical incision to last suture has been placed, an expected average of 30 minutes.||||||
34798|NCT01523886|Secondary|Normal Functional Level|Numer of days before re-establing normal functional level|from the day of surgery to re-establishing normal functional level - an expected average of 7 days.||||||
34799|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.|At arrival to the postanesthesia care department, 2 hours and 1 day after surgery||||||
34800|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.|Preoperatively to 7 days after surgery||||||
34801|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).|During dissection of the gallbladder||||||
34802|NCT01523886|Secondary|Surgical Space Conditions|The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.|From surgical incision to last suture has been placed, an expected average of 30 minutes.||||||
34803|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest|From surgical incision to last suture has been placed, an expected average of 30 minutes.||||||
34804|NCT01523886|Primary|The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less|The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 (“optimal”) = “optimal” surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.|From surgical incision to last suture has been placed, an expected average of 30 minutes|||percentage of patients|||Number
44702|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed on the first postoperative day after mastectomy|||units on a scale||Inter-Quartile Range|Median
34810|NCT01523743|Primary|Quality of Life (0-100 Point)|Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.|6 weeks|The primary analysis was based on the ITT population which included 118 subjects. 7 subjects were excluded from the ITT population. They were excluded because they discontniued the investigation and only baseline data was collected from them. Furthermore, not all subjects in the ITT population answered the QoL questionaire for both products.||units on a scale||Standard Deviation|Mean
34811|NCT01523587|Secondary|Change in Score Over Time in Coughing,Dyspnoea and Pain|"Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race.~Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.~The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table)."|First treatment administration up to 28 days after last intake of study medication|Randomised set i.e. all patients who were randomised regardless of whether they received investigational treatment.||units on a scale||Standard Error|Mean
34812|NCT01523587|Secondary|Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.|Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.|First treatment administration up to 28 days after the last intake of study medication.|Randomised set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||months||95% Confidence Interval|Median
34813|NCT01523587|Secondary|Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire|"Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30 questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at EOT and follow up prior to clinical assessment. The results displayed show improvement in the relevant criteria.~For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The proportion of patients that were improved: Change in cough; dyspnoea and pain scores over time."|First treatment administration up to 28 days after the last intake of study medication.|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||participants|||Number
34814|NCT01523587|Secondary|Tumour Shrinkage|"Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review.~The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation.~A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size."|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.||percentage of decrease||Standard Deviation|Mean
34815|NCT01523587|Secondary|Disease Control According to RECIST 1.1|Disease control (defined as CR, PR or Stable Disease (SD)) according to RECIST 1.1.|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||participants|||Number
34816|NCT01523587|Secondary|Objective Response According to RECIST 1.1|Objective response as defined by RECIST 1.1 as either complete response (CR) or partial response (PR).|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||participants|||Number
34817|NCT01523587|Secondary|Overall Survival|"The primary analysis of Overall Survival (OS) will be conducted after 632 deaths have occured.~Overall Survival is defined as the time from randomisation to death."|From randomisation until 632 deaths||08/2017||||
34818|NCT01523587|Primary|Progression-free Survival, Based on Central Independent Review as Determined by RECIST 1.1|The primary endpoint of this study was Progression Free Survival (PFS), as determined by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. PFS was defined as the time from randomisation to disease progression (or death if the patient died before progression).|First treatment administration up until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.||Months||95% Confidence Interval|Median
34819|NCT01523392|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available||ng/mL||Standard Deviation|Geometric Mean
34820|NCT01523392|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available||ng/mL||Standard Deviation|Geometric Mean
34821|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8||At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
34822|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose||At 0.5 hour and 8 hours after the loading dose|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
34823|NCT01523392|Primary|Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose||At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=32) - included all participants for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel||PRU||95% Confidence Interval|Least Squares Mean
34824|NCT01523366|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The SD is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|PK Analysis Set||ng/mL||Standard Deviation|Geometric Mean
34825|NCT01523366|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set, defined as all participants for whom at least one valid PK reading was available||ng/mL||Standard Deviation|Geometric Mean
34826|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8|The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
34827|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 0.5 and 8 hours after the loading dose|PD Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
34828|NCT01523366|Primary|Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set||PRU||95% Confidence Interval|Least Squares Mean
34829|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)|The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
34830|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)|The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
34831|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)|The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
34832|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (Motor Subscale)|Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson’s disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
34833|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)|The UPDRS Part II is a tool to measure Activities in Daily Living – it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
34834|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)|The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
34835|NCT01523301|Primary|Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)|The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.||units on a scale||95% Confidence Interval|Least Squares Mean
34836|NCT01522976|Primary|Overall Survival (Phase III)|"OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.~This trial did not move forward to the Phase III portion, so results for this Phase III primary outcome cannot be reported. Overall survival is reported for the Phase II cohort as a secondary outcome."|Up to 5 years||||||
34837|NCT01522976|Secondary|Toxicity Rate|Adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Analysis includes only eligible patients who also received treatment.||Participants|||Number
34838|NCT01522976|Secondary|Pre-study Cytogenetic Abnormalities|Cytogenetic risk group is used to identify cytogenetic abnormalities.|Up to 5 years|Analysis includes eligible patients only.||participants|||Number
34839|NCT01522976|Secondary|Overall Survival|OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow- up for patients last known to be alive is censored at the date of last contact. OS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients only.||Days||95% Confidence Interval|Median
34840|NCT01522976|Secondary|Relapse-free Survival|RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients who had a response.||Days||95% Confidence Interval|Median
34841|NCT01522976|Primary|Response Rate (Phase II)|A response is any of complete hematological remission, partial remission, or hematologic improvement.|Up to 5 years|Analysis includes eligible patients only.||percentage of patients having a response||95% Confidence Interval|Number
34842|NCT01522924|Primary|Change From Baseline in Tobacco Cessation Knowledge Score|The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.|Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
34843|NCT01522924|Primary|Change From Baseline in Intentions Score|Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
34844|NCT01522924|Primary|Change From Baseline in Self-efficacy Score|Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.|Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
34845|NCT01522924|Primary|Change From Baseline in Perceived Skills Score|The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|||units on a scale||Standard Deviation|Mean
34857|NCT01522456|Secondary|Cumulative Tolerability (Combined)|Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
34858|NCT01522456|Secondary|Cumulative Tolerability (Stinging/Burning)|Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
34846|NCT01522924|Primary|Change From Baseline in Subjective Norms Score|Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.|Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The number of participants for analysis was determined by the completing the questionnaire after the lecture or after the counseling practice sessions using standardized patients.||units on a scale||Standard Deviation|Mean
34847|NCT01522924|Primary|Change From Baseline in Perceived Barriers Score|The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)|The number of participants for analysis was determined by completing the second questionnaire after the lecture or after the counseling practice sessions using standardized patients.||units on a scale||Standard Deviation|Mean
34848|NCT01522924|Primary|Change From Baseline in Attitude Score|"The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) It is important for members of the profession to discuss tobacco use with patients and 2.) A brief intervention (3 minutes) for tobacco cessation with my patients would be effective. The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2."|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The control group (lecture only) completed the second questionnaire after the lecture and the intervention group (counseling practice sessions) completed the second questionnaire after the counseling practice sessions and the debriefing session.||units on a scale||Standard Deviation|Mean
34849|NCT01522703|Primary|Exhaled Nitric Oxide Concentrations|exhaled nitric oxide concentrations|at 3 days|||ppb||Inter-Quartile Range|Median
34850|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Overall Tolerability Preference Survey Results|Overall Tolerability Preference Survey Results at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type (FST). Data collected from available subjects on day 22. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). One subject did not participate in the User Preference Survey; as a result, 1 subject was not included in the FST I - III group results below.|Day 22|||participants|||Number
34851|NCT01522456|Post-Hoc|Fitzpatrick Skin Type User Preference Survey at Day 22|User Preference Survey at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type. Fitzpatrick skin type (FST) is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). Two subjects did not participate in the User Preference Survey; as a result, 2 subjects were not included in the FST I - III group results below.|Day 22|||participants|||Number
34852|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Stinging/Burning. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
34853|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Dryness. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
34854|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Scaling. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
34855|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Erythema. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population||participants|||Number
34856|NCT01522456|Other Pre-specified|Overall Tolerability Preference Survey|Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.|Day 22|Safety population||participants|||Number
35081|NCT01519960|Secondary|Quantitative HBsAg Level in Group C|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.||log10 IU/mL||Standard Deviation|Mean
34859|NCT01522456|Secondary|Cumulative Tolerability (Dryness)|Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
34860|NCT01522456|Secondary|Cumulative Tolerability (Scaling)|Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
34861|NCT01522456|Secondary|Cumulative Tolerability (Erythema)|Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population||scores on a scale|||Number
34862|NCT01522456|Secondary|Tolerability at Day 22 (Stinging/Burning)|Tolerability assessments at day 22 for stinging/burning|Day 22|Safety population||participants|||Number
34863|NCT01522456|Primary|Worst Postbaseline Tolerability (Stinging/Burning)|Worst postbaseline tolerability assessments for stinging/burning|Day 1 - Day 22|Safety population||participants|||Number
34864|NCT01522456|Secondary|Tolerability at Day 22 (Scaling)|Tolerability assessments at day 22 for scaling|Day 22|Safety population||participants|||Number
34865|NCT01522456|Primary|Worst Postbaseline Tolerability (Dryness)|Worst postbaseline tolerability assessments for dryness.|Day 1 - Day 22|Safety population||participants|||Number
34866|NCT01522456|Primary|Worst Postbaseline Tolerability (Scaling)|Worst postbaseline assessment for scaling.|Day 1 - Day 22|Safety population||participants|||Number
34867|NCT01522456|Other Pre-specified|User Preference Survey (Subjects)|"Response from subjects when asked: Which side of the face feels less irritated? Data collected from available participants on each assessment day."|Day 5, day 12, day 19, and day 22|Safety population||participants|||Number
34868|NCT01522456|Other Pre-specified|User Preference Survey (Investigator)|"Response from investigator when asked: Which side of the face appears to be less irritated? Data collected from available participants."|Day 5, day 12, day 19, and day 22|Safety population||participants|||Number
34869|NCT01522456|Secondary|Tolerability at Day 22 (Dryness)|Tolerability assessments at day 22 for dryness|Day 22|Safety population||participants|||Number
34870|NCT01522456|Secondary|Tolerability at Day 22 (Erythema)|Tolerability assessments at day 22 for erythema|Day 22|Safety population||participants|||Number
34871|NCT01522456|Primary|Worst Postbaseline Tolerability (Erythema)|Worst postbaseline tolerability assessment for erythema.|Day 1 - Day 22|Safety population||participants|||Number
34872|NCT01522339|Secondary|MRI Image Quality|The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.|Post MRI Scan for Each Infant|Number of NICU MRI Images with Equal or Better Quality than Adult Scanner Images||Images|||Number
34873|NCT01522339|Primary|Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam|Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.|Day 1|||Adverse Events|||Number
34874|NCT01522131|Secondary|Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)|Patients with periodontitis lose bone and clinical attachment over a period of time in vertical direction also. In both control and test a UNC probe marked in mm was used to quantify this loss or gain of clinical attachment in a vertical direction from the cemento-enamel junction to the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done.This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. Increase and decrease of vertical probing depth will be noted by a positive number.|At Baseline and 6 months|||mm||Standard Deviation|Mean
34875|NCT01522131|Primary|Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.|Patients with periodontitis lose bone and clinical attachment over a period of time. In both control and test a Nabers probe( curved probe) marked in mm was used to quantify this loss or gain of clinical attachment in a horizontal direction from the cemento-enamel junction to the the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done. This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. If there is a loss in attachment it will be denoted by negative number. If theres a gain in attachment it will be denoted by a positive number after the comparison.|At Baseline and 6 months|||mm||Standard Deviation|Mean
34876|NCT01521923|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2|"LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2.~DAS28 values range from 2.0 to 10.0 with a higher value indicating a higher disease activity."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34877|NCT01521923|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|The Arthritis interference in the last month with household productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34878|NCT01521923|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days missed of family/social/leisure activities in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
34879|NCT01521923|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with hired outside help days in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
34880|NCT01521923|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with reduced household work productivity in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
34881|NCT01521923|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with no household work in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2."||days||Standard Deviation|Mean
34882|NCT01521923|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.~Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34883|NCT01521923|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"Number of work days with reduced productivity in the last month for employed subjects.~Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
34884|NCT01521923|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of work days missed in the last month for employed subjects.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||days||Standard Deviation|Mean
34885|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2|BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue), whereas the score for each dimension is different due to the varied number of questions (0 –22 for physical, 0- 21 for living, 0- 15 for cognition, and 0- 12 for emotion). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34886|NCT01521923|Secondary|Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"Time to flare, defined as an increase of DAS28[ESR] >= 0.6 above Week 52 DAS28[ESR] level, having a DAS28[ESR] >= 3.2 and judged by the Investigator as due to RA and all three criteria confirmed at an additional visit two weeks thereafter, from Week 52 onwards.~Data not available as > 75% of the participants failed to meet flare criteria."|Week 104 in RA0055 Period 2|"FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||days||Geometric Coefficient of Variation|Geometric Mean
34887|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34888|NCT01521923|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2|"Normative physical function is defined as HAQ-DI score <= 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34889|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34890|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34891|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.A negative value in CDAI change from Baseline indicates an improvement from Baseline.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34892|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.~A negative value in CDAI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34893|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.~A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34894|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.~A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||units on a scale||Standard Deviation|Mean
34895|NCT01521923|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2|"Good response is defined as:~DAS28[ESR] <= 3.2 and decrease from Baseline by >1.2;~moderate response is defined as achievement of one of the following:~DAS28[ESR] <= 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28[ESR] > 5.1 and decrease from Baseline >1.2.~LOCF= Last Observation Carried Forward"|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34896|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:~Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1 and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34897|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34898|NCT01521923|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34899|NCT01521923|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34900|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2|"The ACR/EULAR 2011 remission criteria is defined as:~Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1, C-Reactive Protein (CRP) <= 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34901|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2|The assessments are based on a 70 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34908|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.~Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||percentage of subjects|||Number
34902|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2|The assessments are based on a 50 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34903|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2|The assessments are based on a 20 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34904|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
34905|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
34906|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
34907|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
35095|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Group C|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population.||percentage of participants|||Number
34909|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.~Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||percentage of subjects|||Number
34910|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
34911|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."||units on a scale||Full Range|Median
34912|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|Full Analysis Set Period 2 (FAS2) with Non-Responder Imputation (NRI). FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.||percentage of subjects|||Number
34913|NCT01521923|Primary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring|This Outcome Measure includes all subjects that have a DAS28 [ESR] <= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"||percentage of subjects|||Number
34914|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccination Sites|Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
34915|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccines|Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
34916|NCT01521897|Other Pre-specified|Number of Participants by Vaccination Sites at Each Vaccination Time|Number of participants was counted by vaccination sites at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
34917|NCT01521897|Other Pre-specified|Number of Participants by Month of Age at Each Vaccination Time|Number of participants was counted by month of age at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
34940|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4|||units on a scale||Standard Deviation|Mean
34918|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
34919|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
34920|NCT01521897|Secondary|Number of Participants With Injection Site Reactions|Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for “injection site erythema”; induration for “injection site erythema” and “injection site swelling”; tenderness for ”injection site pain”; and warmth for “injection site warmth”.|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||Participants|||Number
34921|NCT01521897|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
34922|NCT01521897|Primary|Number of Participants With Adverse Reactions|An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.||participants|||Number
34923|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated. DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||correlation coefficient|||Number
34924|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated. DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||correlation coefficient|||Number
34925|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||correlation coefficient|||Number
34956|NCT01521845|Primary|Cardiac Necrosis Biomarkers (CKMB, Troponin I)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention|||ng/ml||Inter-Quartile Range|Median
34926|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)|Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.|Baseline, Month 6,1 2, 18, 24|ITT population, Here “n” = participants evaluable for this measure for specified component score and “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||correlation coefficient|||Number
34927|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated. AIMS2 : 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||correlation coefficient|||Number
34928|NCT01521884|Secondary|Health Assessment Questionnaire (HAQ) Total Score|HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of item scores. HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
34929|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
34930|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)|DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score=more disease activity (DA). DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
34931|NCT01521884|Secondary|Visual Analog Scale (VAS) Fatigue Score|Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.||units on a scale||Standard Deviation|Mean
34932|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
35096|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Group C|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants|||Number
34933|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 18|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
34934|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 12|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
34935|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 6|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
34936|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Baseline|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.||units on a scale||Standard Deviation|Mean
34937|NCT01521871|Primary|Patients´Self Satisfaction.|"The patients` self-satisfaction was evaluated by means of a questionnaire rating the following 3 domains on a numerical (1-5) scale:~Total satisfaction regarding wound healing/wound care. 1 (satisfied) to 5 (dissatisfied)~Satisfaction regarding wound discomfort; pain, itching, paresthesia, pressure etc. 1 (almost no discomfort) to 5 (lot of discomfort)~Satisfaction regarding wound care; suppleness, practicability versus mobilization, showering etc. 1 (almost no practical challenges) to 5 (lot of practical challenges)~Patients' Self Satisfaction score was the sum of three domains, ranges from 3 (completely satisfied) to 15 (completely dissatisfied).~These data were collected at the day of discharge, with guidance from two interviewers."|These data were collected at the day of discharge from hospital (postoperative day 4-8).|||units on a scale||Standard Deviation|Mean
34938|NCT01521871|Primary|TIme Consumption|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.|||minutes||Standard Deviation|Mean
34939|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
37114|NCT01491035|Primary|Cmax of Lu AA34443|Maximum plasma concentration of the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set||ng/mL||Standard Deviation|Median
34941|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2|||units on a scale||Standard Deviation|Mean
34942|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
34943|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)|||units on a scale||Standard Deviation|Mean
34944|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 2 (2 days after kidney donation)|||units on a scale||Standard Deviation|Mean
34945|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
34946|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4|||units on a scale||Standard Deviation|Mean
34947|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2|||units on a scale||Standard Deviation|Mean
34948|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
34949|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4|||units on a scale||Standard Deviation|Mean
34950|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2|||units on a scale||Standard Deviation|Mean
34951|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7|||units on a scale||Standard Deviation|Mean
34952|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)|||units on a scale||Standard Deviation|Mean
34953|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postoperative day 2 (2 days after kidney donation)|||units on a scale||Standard Deviation|Mean
34954|NCT01521845|Secondary|MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death||30 days|||participants|||Number
34955|NCT01521845|Primary|Inflammation Marker (CRP)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention|||mg/l||Inter-Quartile Range|Median
34957|NCT01521780|Secondary|Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.|Resected tumors and adjacent tissues were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for LDL-R protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
34958|NCT01521780|Secondary|Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
34959|NCT01521780|Secondary|Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin mRNA by qRT-PCR.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
34960|NCT01521780|Secondary|Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to derive a Median ADC for each tumor. The mean of the Median ADCs is presented based on tumours as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only eight of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.||um^2/s|Participants|Standard Deviation|Mean
34961|NCT01521780|Secondary|Tumor Volumes From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to determine the volume of each tumor. The mean of log tumor volume is presented, based on tumors as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only ten of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.||log cm^3|Participants|Standard Deviation|Mean
34962|NCT01521780|Primary|Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
34963|NCT01521780|Primary|Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.|||||
34964|NCT01521559|Secondary|Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline to week 24|FAS||scores on a scale||Standard Deviation|Mean
34965|NCT01521559|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF|CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).|Baseline to week 24|FAS||microns||Standard Deviation|Mean
34966|NCT01521559|Secondary|Change From Baseline to Week 24 in BCVA Score - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to Week 24|FAS||letters correctly read||Standard Deviation|Mean
34967|NCT01521559|Primary|Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to week 24|FAS||participants|||Number
34968|NCT01521546|Primary|12-month Change in Myocardial Strain|a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline.|baseline and 12 months|||percent change in heart dimension||Inter-Quartile Range|Median
34969|NCT01521507|Secondary|Stage 2 Mean Total OSDI Score at 12 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. Frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. The total OSDI score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat (All participants who received at least a partial LipiFlow treatment or Crossover LipiFlow treatment and had data available at 12 Months). The Two LipiFlow treatments subgroup was not analyzed because the sample size (n<5) was too small for meaningful analysis.||units on a scale||95% Confidence Interval|Mean
34970|NCT01521507|Secondary|Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. To be eligible for the study, the Baseline total OSDI score must have been 13 points or higher in each eye. Change=3 Months score-Baseline score.|Baseline, 3 Months|Intent to Treat Population (All participants who were randomized and received at least partial device treatment or used warm compress at least once and had data available at 3 Months).||units on a scale||95% Confidence Interval|Mean
34971|NCT01521507|Primary|Stage 2 Mean Total Meibomian Gland Score at 12 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat Population (All participants who received at least partial LipiFlow or Crossover LipiFlow treatment and had data available at 12 Months). Two LipiFlow treatments subgroup was not analyzed because sample size was too small (n<5) for meaningful analysis.||units on a scale||95% Confidence Interval|Mean
34972|NCT01521507|Primary|Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.|Baseline and 3 Months|Intent to Treat Population (All Participants who were randomized and received at least partial LipiFlow treatment or used warm compress therapy at least once and had data available at 3 Months).||units on a scale||95% Confidence Interval|Mean
34973|NCT01521364|Secondary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Saliva.|The data will be used to clinically validate the analysis linezolid in saliva as surrogate marker for linezolid in plasma.|At week 3 (after co-administration of 250mg clarithromycin)||||||
34974|NCT01521364|Secondary|Pharmacokinetic Parameters, e.g. Tmax, T1/2, Cmax, Cmin, Cl, of Anti-TB Drugs That Are Co-administered as Part of the Continued Standard Care.||At week 1 (baseline), week 3 (250mg clarithromycin) and week 5 (500mg clarithromycin)||||||
34975|NCT01521364|Secondary|Number of Patients With Adverse Events (AEs)|To assess short-term safety and tolerability when combining linezolid (LIN) with clarithromycin (CLA) by monitoring AEs, i.e. gastro-intestinal effects, hyperlactatemia, haematological abnormalities and neuropathy.|Up to week 6|No serious adverse events||participants|||Number
34976|NCT01521364|Secondary|Linezolid (LIN) and Clarithromycin (CLA) Pharmacokinetic Parameters, e.g. Tmax, Cmax, Cmin, T1/2, Cl.||At week 1 (baseline), week 3 (250mg clarithromycin), and week 5 (500mg clarithromycin) and week 6 (baseline).||||||
34977|NCT01521364|Primary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Plasma After Addition of 0mg, 250mg, or 500mg Clarithromycin (CLA).|"The AUCs of linezolid will be measured at 3 time points after addition of 3 different clarithromycin dosages.~Samples were obtained before doseing and 1h, 2h, 3h, 4h, 8h, and 12h after administration of linezolid (and claritromycin depending on the period)."|At week 1 (baseline), week 3 (250mg clarithromycin), and week 5(500mg clarithromycin).|||mg*h/L||Inter-Quartile Range|Median
34978|NCT01521260|Secondary|Complications and Adverse Events||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34979|NCT01521260|Secondary|Implant Failure|defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection|baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34980|NCT01521260|Secondary|Marginal Soft Tissue Recession||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34981|NCT01521260|Secondary|Presence of Calculus||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34982|NCT01521260|Secondary|Presence of Plaque||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34983|NCT01521260|Secondary|Radiographic Marginal Bone Level on Standardized Intraoral Radiographs||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34984|NCT01521260|Secondary|Microbiological Composition of the Peri-implant Sulcus||baseline (T0), 3 and 12 months after intervention (T3, T12)||||||
34985|NCT01521260|Secondary|Suppuration on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34986|NCT01521260|Secondary|Probing Pocket Depth||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
34987|NCT01521260|Secondary|Bleeding on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)||||||
35000|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)|AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose|Day 1|||ng.h/mL||Standard Deviation|Mean
34988|NCT01521260|Primary|Change in Total Bacterial Load on the Exposed Implant Surface|Total bacterial load as obtained by sweeping a microbrush across the implant surface after flap deflection. Samples are obtained immediately after flap deflection and granulation tissue removal AND after the decontamination procedure (mechanical debridement, rinsing of the implant surface using the placebo or chlorhexidine solution, saline rinsing) but before flap closure. The log-transformed mean change in bacterial load is calculated (difference between the two time points --> difference in sample BEFORE decontamination and AFTER decontamination procedure).|During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.|||log (colony forming units/ml)|Participants|Standard Deviation|Log Mean
34989|NCT01521143|Secondary|Part B - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
34990|NCT01521143|Secondary|Part B - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
34991|NCT01521143|Secondary|Part B - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
34992|NCT01521143|Secondary|Part A - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
34993|NCT01521143|Secondary|Part A - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
34994|NCT01521143|Primary|Part A - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.|||||
34995|NCT01521026|Secondary|Hopkins Verbal Learning Test Percent Retained|"Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial.~Score ranges from 0-100. Higher scores represent better performance."|3 months|||units on a scale||Standard Deviation|Mean
34996|NCT01521026|Primary|UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)|Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.|3 months|||units on a scale||Standard Deviation|Mean
34997|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||hours||Full Range|Median
34998|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|"Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose"|Day 1|||hours||Full Range|Median
34999|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)|"AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||ng.h/mL||Standard Deviation|Mean
35111|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35001|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10)|"AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||ng.h/mL||Standard Deviation|Mean
35002|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1)|"AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose."|Day 1|||ng.h/mL||Standard Deviation|Mean
35003|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10|||ng/mL||Standard Deviation|Mean
35004|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.|Day 1|||ng/mL||Standard Deviation|Mean
35005|NCT01520922|Secondary|Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR)|An Infusion reaction is defined as events occurring after the beginning of an infusion of ofatumumab or within 24 hours following the end of an infusion of bendamustine.|From the first dose of study medication to 60 days after the last dose of study medication (up to 24 hours after last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.||Participants|||Number
35006|NCT01520922|Secondary|Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|ZAP-70 is a protein normally expressed near the surface membrane of T cells and natural killer cells. ZAP-70 in B cells is used as a prognostic marker in identifying different forms of CLL. Participants with ZAP-70 testing results intermediate (Int), positive (Pos) and negative (Neg) at Baseline and who had a clinical response after last dose of study treatment are provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35007|NCT01520922|Secondary|Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Participants with IgVH mutation results as mutated and unmutated status and clinical response after last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35008|NCT01520922|Secondary|Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment|Participants with B2M concentration of <=4000 µg/L and >4000 µg/L at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35009|NCT01520922|Secondary|Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Cytogenetics refers to the study of numerical and structural chromosomal abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization [FISH]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35010|NCT01520922|Secondary|Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver)|Organomegaly is the abnormal enlargement of organs. Physical examination of the liver (L) and spleen (S) were done at Screening (SCR), C3D1, C6D1, 12-Month F/U, 24-Month F/U and 36-Month F/U. The result of the physical examination of the liver (L) and spleen (S) was presented as normal (NOR), enlarged (EL) and not assessed (NOA).|Screening (Scr), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 -Month Follow-Up (F/U)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35011|NCT01520922|Secondary|Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline|Lymph nodes were evaluated by physical examination which involved recording the diameter in two planes (sum of the product of the diameter [SPD]) of the largest palpable node in each of the following sites: cervical, axillary, supraclavicular, inguinal and femoral. Lymphadenopathy is defined as lymph nodes with the largest diameter greater than 1.5 centimeters. The maximum reduction in SPD from Baseline at C2D1, C3D1, C4D1, C5D1, C6D1, 3-Month F/U, 6-Month F/U and 9-Month F/U are provided.|Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), 3-Month Follow-Up (F/U), 6-Month F/U and 9-Month F/U|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||cm^2 (centimeters squared)||Standard Deviation|Mean
35012|NCT01520922|Secondary|Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (C Neg) results.|Cycle 1 Day 1 (C1D1), Cycle 6 Day 1 (C6D1), 6-Month Follow-up (F/U), and any post-dose time point|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35013|NCT01520922|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline (BL), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 month follow up (F/U)|Safety Population. All subjects who receive at least one dose of study medication.. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35014|NCT01520922|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms|Participants with the indicated constitutional or B-symptoms (night sweats, weight loss, fever or extreme fatigue) were presented for different time points.|Screening (SCR), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 Month Follow-up (F/U)|Safety Population: All subjects who receive at least one dose of study medication. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
35015|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Event of Infection|Participants with the indicated Grade 3 or Grade 4 adverse event of infection are presented. AEs were graded according to the NCI CTCAE grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: All subjects who receive at least one dose of study medication.||Participants|||Number
35016|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication|Safety Population||Participants|||Number
35017|NCT01520922|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population All subjects who receive at least one dose of study medication.||Participants|||Number
35018|NCT01520922|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.||Participants|||Number
35112|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT in Group C|The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35019|NCT01520922|Secondary|Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the partcipants who were suspected of achieving a primary endpoint CR. Analysis of CD5+ CD19+ was performed on the bone marrow aspirate sample obtained no sooner than 2 months following the last dose of study treatment. MRD results were reported as negative or positive. The absence of MRD (negative MRD) is defined as less than one CLL cell per 10000 leukocytes.|3 month follow up to the 36 Month Follow-up (in 3 month interval)|ATS Population. Number of subjects who had CR with bone marrow confirmation are included. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
35020|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months|CD5-CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5- CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Cell per microliter||Standard Deviation|Mean
35021|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months|CD5+ CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+ CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).||Cell per microliter||Standard Deviation|Mean
35022|NCT01520922|Secondary|Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and end of study treatment (up to 30 months)|Safety Population. Only those participants who were available at the indicated time points were analyzed.||Gram per liter||Standard Deviation|Mean
35023|NCT01520922|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: all participants who received at least one dose of any study treatment (ofatumumab or bendamustine).||Participants|||Number
35024|NCT01520922|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from the date of the first administration of study treatment until the start of the next anti-CLL therapy.|From the start of study treatment until the start of the next anti-CLL therapy (up to 3 years after the last dose of study treatment)|ATS Population. Only participants that took anti-CLL therapy were evaluated.||Months||95% Confidence Interval|Median
35025|NCT01520922|Secondary|Investigator-Assessed Kaplan-Meier Estimates of Time to Progression|Time to progression is defined as the time from the date of the first administration of study treatment to disease progression (PD). PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000 B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From the start of study treatment to disease progression (up to 3 years after the last dose of study treatment)|All treated subjects (ATS). This analysis includes patients who had progression.||Months||95% Confidence Interval|Median
35026|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Overall Survival|OS is defined as the interval of time between the date of the first administration of study treatment and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From the start of study treatment to the date of death due to any cause (up to 3 years after the last dose of study treatment)|All treated subjects. N= Death||Months||95% Confidence Interval|Median
35027|NCT01520922|Secondary|Investigator-assessed of Kaplan-meier Estimates of Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of the first administration of study treatment and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following:new lesion or increase by >=50% from BL in LC, Ly, size of liver and spleen, PL >= 50% decrease from BL, or to <100,000/uL secondary to CLL, Hb decrease of >2 g/dL from BL or to <10 g/dL secondary to CLL, CLL- transformation. Response was determined according to the IWCLL updated NCI-WG guidelines 2008. Participants who have neither progressed or died at the time of analysis were censored at the date of the last adequate assessment. If there was more than 1 scheduled visit missed, PFS is censored at the last adequate assessment of response. An adequate assessment is defined as an assessment where the investigator determined a response of CR, CRi, nPR, PR, or stable disease (SD).|From the start of study treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|All Treated Subjects’ (ATS) population. N= Progression or Death||Months||95% Confidence Interval|Median
35028|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Duration of Response|The duration of response is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of disease progression (PD) or death due to any cause. PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From time of initial response (CR, CRi, nPR, or PR) to disease progression or death, whichever came first (up to 3 years after the last doseof study treatment)|ATS Population. Only participants with an initial response (CR, CRi, nPR, or PR) with PD or death were assessed for duration of response.||Months||95% Confidence Interval|Median
35029|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Time to Response|Time to response is defined as time from date of the first administration of study treatment to the first response (CR, CRi, nPR, or PR). Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR: all of the following criteria at least 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/ thrombocytopenia/ neutropenia unrelated to CLL but related to drug toxicity. nPR: persistent nodules BM. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11.0 g/dL or 50% improvement over BL, LC <4000/µL.|From the start of study treatment to the first response (CR, CRi, nPR, or PR) (up to 3 Month Follow-up (F/U) visit)|ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.||Months||95% Confidence Interval|Median
35030|NCT01520922|Secondary|Number of Participants With Complete Response (CR) With and Without a CT Scan Assessment After the Last Dose of Study Treatment, as Assessed by the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500/µL, platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 g/dL, lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population||Participants|||Number
35031|NCT01520922|Secondary|Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population. OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.||Participants|||Number
35032|NCT01520922|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|As-treated subjects (ATS) Population: all participants who received at least one dose of both study drugs (ofatumumab and bendamustine). OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.||Participants|||Number
35033|NCT01520909|Secondary|Population PK Model Point Estimate for Eltrombopag for Absorption Rate-constant (Ka)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Ka is defined as the absorption rate constant. This parameter is dose independent, and the population estimate Ka is reported.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||1/h|||Number
35034|NCT01520909|Secondary|PK Assessments for Eltrombopag for Apparent Central Volume (Vc/F) and Apparent Peripheral Volume (Vp/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Vc/F is defined as the volume of the central (e.g. plasma) compartment and Vp/F is defined as the volume of the peripheral compartment. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||Liters (L)||95% Confidence Interval|Geometric Mean
35035|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Oral Clearance (CL/F) and Apparent Intercompartmental Clearance (Q/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
35036|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Cmax is defined as the maximum observed concentration. The Cmax for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
35037|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for AUC (0-t)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. The AUC(0-t) for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed||micrograms*hour per milliliter (ug.h/mL)||95% Confidence Interval|Geometric Mean
35038|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Follow-Up Week 24|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Follow-up Week 24 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Follow-Up Week 24 (Week 61)|Safety Population. Only those participants who had worsening visual acuity at Week 61 were analyzed.||Participants|||Number
35039|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 24 of Part 2|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 24 of Part 2 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 24 of Part 2|Safety Population. Only those participants who had worsening visual acuity at Week 24 were analyzed.||Participants|||Number
35040|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 12 of Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 12 of Part 1 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 12 of Part 1|Safety Population. Only those participants who had a result of ‘worsening’ in assessment of change of visual acuity at this timepoint were analyzed.||Participants|||Number
35041|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Follow-Up Week 24|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Follow-Up Week 24 (Study Week 61)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
35042|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 24 of Part 2|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 24 of Part 2|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
35043|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 12 of Part 1|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No (no change from Baseline), Not Clinically Significant (NCS), Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 12 of Part 1|Safety Population||Participants|||Number
35050|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening; requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Part 2 up to Week 24 of Part 2 + 1 day|Safety Population||Participants|||Number
35217|NCT01519765|Secondary|Time to Active Labor|Time from induction to active labor. Active labor defined as 4 cm and above. P-value computed by Kruskal-Wallis test.|Until active labor|||hours||Full Range|Median
35044|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 2|Vital sign measurements were taken before any blood draw and included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard RR as reference range high(RRH) and reference range low(RRL) from SCR up to Week 24 of Part 2 and from Follow-up Week 1 to Week 4. RR for Blood Pressure(mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120; DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR (bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Week 1 up to Week 24 of Part 2 and Follow-up Week 1 to Week 4 (up to Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
35045|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 1|Vital sign measurements were taken before any blood draws and included systolic blood pressure(SBP), diastolic blood pressure(DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard reference ranges RR as reference range high(RRH) and reference range low(RRL). The Baseline(BL) value is defined as the value taken at Day 1 or if missing, the latest non-missing SCR value. RR for Blood Pressure (mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120;, DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR(bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Screening (SCR) up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
35046|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 2|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none, G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline up to Week 24 of Part 2 and Follow-up Weeks 1 to 4 (up to Study Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
35047|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 1|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
35048|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 2|Clinical chemistry parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: AST, ALP, total bilirubin, albumin, ALT, and creatinine. For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For serum creatinine, the value taken at Week 13 of Part 1 will be used as BL. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as BL. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline (BL) of Part 2 through Follow-up|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
35049|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 1|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: Grade 0 (G0), none; Grade 1 (G1), mild; Grade 2 (G2), moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling. Clinical chemistry parameters included: aspartate amino transferase (AST), alkaline phosphatase (ALP), total bilirubin, albumin, alanine amino transferase (ALT), prothrombin international normalized ratio (PT INR), activated partial thromboplastin time (APTT), and creatinine. The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as Baseline. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
35218|NCT01519765|Secondary|Time to Delivery|Time from induction to delivery. All participants were included.|Until delivery|||hours||Full Range|Median
35051|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Treatment up to Week 13 of Part 1+ 1 day|Safety Population: all participants who received at least one dose of the investigational product||Participants|||Number
35052|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the WHO Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO Grades were dichotomized into the following categories: no bleeding = Grade 0; any bleeding = Grade 1 to 4; no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4.|From Baseline of Part 2 through Follow-up|ITT Population. Only those participants who entered into Part 2 open-label Eltrombopag only phase were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Participants|||Number
35053|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
35054|NCT01520909|Secondary|Number of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During Part 2 Without Requiring Subsequent Rescue Therapy|Participants who discontinued or had a sustained reduction of a baseline immune (idiopathic) thrombocytopenic purpura (ITP) medication during the 24 weeks of Part 2 (Open-Label Period) and without requiring subsequent rescue therapy. For participants randomized to placebo in Part 1, Baseline is defined as Week 13 of Part 1. For participants randomized to eltrombopag in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction was defined as a reduction for 4 weeks or more.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) and taking an ITP medication at Baseline were analyzed.||Participants|||Number
35055|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During Part 2|The maximum duration for which a participant continuously maintained a platelet count of >=50 Gi/L was calculated and summarized for the 24 weeks of eltrombopag dosing (Part 2). Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Weeks||Standard Deviation|Mean
35056|NCT01520909|Secondary|Number of Weeks in Which Participants Achieved a Platelet Count >=50 Gi/L, Between Weeks 4 and 24 of Part 2|Platelet response was analyzed after Week 4 for the eltrombopag-only period to allow participants who had been randomized to placebo in the Randomized Period time to escalate to their optimal dose of eltrombopag. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Week 4 up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Weeks||Standard Deviation|Mean
35057|NCT01520909|Secondary|Number of Participants Who Achieved a Platelet Count >=50 Gi/L at Any Time During Part 2|Participants who achieved a platelet count >=50 Gi/L at any time during Part 2 (up to Week 24) were reported.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.||Participants|||Number
35058|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 1|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline was defined as the Day 1 assessment or the latest possible screening assessment.|From Baseline through Follow-up of Part 1|ITT Population. Only those participants that did not enroll in Part 2 were analyzed during the follow-up visits. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).||Participants|||Number
35059|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1|Rescue treatment is defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 12 of Part 1|ITT Population||Participants|||Number
35060|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the First 12 Weeks of Part 1|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L was calculated and summarized for the first 12 weeks of Part 1. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 12 of Part 1|ITT Population||Weeks||Standard Deviation|Mean
37115|NCT01491035|Primary|t½ of Vortioxetine|Half-life of vortioxetine in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||h||Standard Deviation|Median
35061|NCT01520909|Secondary|Weighted Mean Platelet Count|"The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the study (12 weeks). Weighted mean platelet counts from baseline to week 12 of the randomized period was compared between placebo and eltrombopag using an analysis of covariance model (ANCOVA) adjusting for baseline platelet count and age cohort. For each subject the area between two adjacent visits with platelet counts was calculated. The area was calculated for all pairs of adjacent visits starting at Day 1 of randomized period and then the total sum of all the areas was divided by the total duration of time during the randomized period. For each subject, this method calculates an ‘average’ platelet count and it allows the possibility that subjects may have had different number of assessments during different times relative to baseline."|Baseline and Week 12 of Part 1|ITT Population. Only those participants with a value at Baseline and post-Baseline were analyzed.||Gi/L||Standard Deviation|Mean
35062|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 6 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 6 weeks of Part 1 were reported.|From Baseline up to Week 6 of Part 1|ITT Population||Participants|||Number
35063|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 12 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 12 weeks of Part 1 were reported.|From Baseline up to Week 12 of Part 1|ITT Population||Participants|||Number
35064|NCT01520909|Secondary|Percentage of Responders|Percentage of participants who responded (defined as platelet count >= 50 Gi/L in absence of rescue) at least once up to week 12 of Part 1 (Odds of achieving a platelet count >=50 Gi/L during the first 12 weeks of Part 1)|From Week 1 up to Week 12 of Part 1|ITT Population||Percentage of participants|||Number
35065|NCT01520909|Primary|Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1|Participants who achieved a platelet count >=50 Gi/L for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1, were reported.|From Week 5 up to Week 12 of Part 1|Intent-to-Treat (ITT) Population: all randomized participants. The ITT Population was the primary population used for assessing efficacy.||Participants|||Number
35066|NCT01520727|Secondary|Time to Cmax (Tmax)||pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose|||hours||Full Range|Median
35067|NCT01520727|Secondary|Cmax - BIA 9-1067|Cmax - maximum plasma concentration|pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose|||ng/mL||Standard Deviation|Mean
35068|NCT01520727|Primary|Adverse Events (AEs)|Safety was evaluated from the number of reported adverse events (AEs)|7 weeks|||Number of Adverse Events|||Number
35069|NCT01520714|Primary|Evidence of Change in Threshold of >1 Volt With Posture Changes||6 months|Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.|||||
35070|NCT01520532|Secondary|Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.|The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.|Day 1 (End of Procedure)|All subjects who underwent ablation and post-procedure MRI.||participants|||Number
35071|NCT01520532|Secondary|Acute Safety Events|Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.|30 days|All subjects who underwent an ablation and post-procedure MRI||events|||Number
35072|NCT01520532|Primary|New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.|An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.|Within 1-3 days post ablation|All subject who underwent an ablation and post-procedure MRI.||participants|||Number
35073|NCT01520506|Secondary|Renal Denervation Procedure Effectiveness|Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline|From baseline to 6 months|||percentage of participants|||Number
35074|NCT01520506|Secondary|Chronic Procedural Safety|Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months|6 months|||percentage of participants|||Number
35075|NCT01520506|Primary|Acute Procedural Safety|"Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:~SAE's related to groin and vascular access complications, and~SAE's related to renal artery injury."|One Week|||percentage of participants|||Number
35076|NCT01520402|Primary|Median Cumulative Warfarin Dose Requirement by Genotype Category (CYP2C9 and VKORC1 -1639 G>A Combination)|Subjects were also grouped into four categories based on CYP2C9 and VKORC1 genotype profile: Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant). Median cumulative warfarin dose requirement was determined for each genotype category.|2-30 days|Of the 35 subjects enrolled, 30 were included in the study as above.||milligrams||Inter-Quartile Range|Median
35077|NCT01520402|Secondary|Explained Variation in Combined Therapeutic Warfarin Dose Models|The proportion of variance (R^2) explained by each predictor was calculated using multivariate regression analysis and adjusted for age, gender and reported race, with outcome values logarithmically transformed. The study was powered to detect R^2 > 20%, and significance was accepted at p<0.05.|average of 2 - 30 days|Of the 35 subjects enrolled, 30 completed the study as described above.||proportion of variance|||Number
35078|NCT01520402|Secondary|Median Cumulative Warfarin Dose Requirements by CYP4F2 Genotype Status|To assess the effect of CYP4F2 genotype variants on the anticoagulant response to warfarin.|average of 2 - 30 days|Of 35 subjects were enrolled, 30 were included as listed above.||milligrams||Inter-Quartile Range|Median
35079|NCT01520402|Primary|Median Cumulative Therapeutic Warfarin Dose (Milligrams)Requirements by Genotype|To assess the effect of genotype variants (CYP2C9 and VKORC1 -1639 G>A) on the anticoagulant response to warfarin, the primary outcome was the cumulative dose required to achieve an INR value in the usual clinical therapeutic range (>2.0) for two consecutive days.|average of 2 - 13 days|Of the 35 subjects enrolled, 30 were included in the study as listed above.||milligrams||Inter-Quartile Range|Median
35082|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Group C|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||log10 PEIU/mL||Standard Deviation|Mean
35083|NCT01519960|Secondary|Quantitative HBeAg Level in Group C|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 PEIU/mL||Standard Deviation|Mean
35084|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Group C|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
35085|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Groups A and B|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||log10 IU/mL||Standard Deviation|Mean
35086|NCT01519960|Secondary|Quantitative HBsAg Level in Groups A and B|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
35087|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Groups A and B|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||log10 PEIU/mL||Standard Deviation|Mean
35088|NCT01519960|Secondary|Quantitative HBeAg Level in Groups A and B|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL).|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 PEIU/mL||Standard Deviation|Mean
35089|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Groups A and B|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
35090|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35091|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||standard deviations||Standard Deviation|Mean
35092|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|Safety Population.||standard deviations||Standard Deviation|Mean
35093|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||standard deviations||Standard Deviation|Mean
35094|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||standard deviations||Standard Deviation|Mean
35097|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||percentage of participants|||Number
35098|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||percentage of participants|||Number
35099|NCT01519960|Secondary|Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category|AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL).|Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)|"PK Substudy Population: All participants who consented to participate in the PK substudy. The Number of Participants Analyzed reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table."||h*ng/mL||Full Range|Mean
35100|NCT01519960|Secondary|Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C|Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis.|Baseline; Week 48; FU Week 24 (up to 72 weeks overall)|"Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."||kPa||Standard Deviation|Mean
35101|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Group C|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
35102|NCT01519960|Secondary|Quantitative HBV DNA Level in Group C|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
35103|NCT01519960|Secondary|Quantitative Serum ALT Level in Group C|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
35104|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35105|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35106|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35107|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35108|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35109|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35110|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT in Group C|The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35113|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.||percentage of participants||95% Confidence Interval|Number
35114|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35115|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35116|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35117|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35118|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35119|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35120|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35121|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.||percentage of participants||95% Confidence Interval|Number
35122|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.||percentage of participants||95% Confidence Interval|Number
35123|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Groups A and B|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
35124|NCT01519960|Secondary|Quantitative HBV DNA Level in Groups A and B|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||log10 IU/mL||Standard Deviation|Mean
35125|NCT01519960|Secondary|Quantitative Serum ALT Level in Groups A and B|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.||factor of ULN||Standard Deviation|Mean
35126|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35127|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35219|NCT01519765|Secondary|Time to Vaginal Delivery|Time from start of induction to vaginal delivery was computed in participants who achieved vaginal delivery.|Start of induction until vaginal delivery|Participants who achieved vaginal delivery were included in the analysis||hours||Full Range|Median
35128|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35129|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35130|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35131|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT/POP in Groups A and B|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35132|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35133|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35134|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35135|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.||percentage of participants||95% Confidence Interval|Number
35136|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35137|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35138|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35139|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35140|NCT01519960|Secondary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35141|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B|Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35142|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35143|NCT01519960|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35144|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.||percentage of participants||95% Confidence Interval|Number
35145|NCT01519960|Primary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.||percentage of participants||95% Confidence Interval|Number
35146|NCT01519934|Secondary|Patient Satisfaction|Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.|180 days post-treatment|||percentage of participants|||Number
35147|NCT01519934|Secondary|Subject Perception of Age|"Percentage of subjects rated as looking younger as measured using a Subject Perception of Age questionnaire."|Baseline to 180 days post-treatment|||percentage of participants|||Number
35148|NCT01519934|Secondary|Overall Aesthetic Improvement|"Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"|Baseline to 180 days post-treatment|||percentage of participants|||Number
35149|NCT01519934|Primary|Improvement in Overall Lifting and Tightening of the Skin|Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.|Baseline to 180 days post-treatment|||percentage of participants|||Number
35150|NCT01519921|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.|Up to Week 72|Safety population included participants who received at least one dose of study medication and who had at least one post-baseline safety assessment.||Participants|||Number
35151|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72|A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
35152|NCT01519921|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72|A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
35153|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion|A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
35154|NCT01519921|Secondary|Percentage of Participants With a Combined Response At Week 48 and Week 72|A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
35155|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72|Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
35156|NCT01519921|Secondary|Percentage of Participants With ALT Normalization At Week 48 and Week 72|Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
35157|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72|Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.|Week 72|The ITT population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
35158|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.|Week 72|Intent-to-treat (ITT) population included all participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
35159|NCT01519882|Secondary|Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~The number of turnings in bed was determined via a postural sensor placed on the subject’s chest."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||Number of turnings in bed|||Number
35160|NCT01519882|Secondary|Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~Sleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by:~(Time in bed (Period between lights off and lights on))-(Sleep time)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||minutes||Standard Deviation|Mean
35161|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
35162|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
35163|NCT01519882|Secondary|Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~The sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by:~(Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||minutes||Standard Deviation|Mean
35164|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period|"The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:~0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.~The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
35165|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period|"The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:~0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.~The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
35166|NCT01519882|Secondary|Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period|"The PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.~Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
35167|NCT01519882|Secondary|Change From Baseline in the Parkinson’s Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.~Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)|||units on a scale||Standard Deviation|Mean
35168|NCT01519882|Primary|Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period|"The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between lights off and lights on)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)|||percentage change||Standard Deviation|Mean
35169|NCT01519791|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52|LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35220|NCT01519765|Primary|Vaginal Delivery Within 24 Hours of Labor Induction|Percentage of participants able to achieve vaginal delivery within 24 hours of labor induction.|Within 24 hours of labor induction|||percentage of participants||95% Confidence Interval|Number
35170|NCT01519791|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||units on a scale||Standard Deviation|Mean
35171|NCT01519791|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
35172|NCT01519791|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
35173|NCT01519791|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
35174|NCT01519791|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
35175|NCT01519791|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||units on a scale||Standard Deviation|Mean
35176|NCT01519791|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
35177|NCT01519791|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.||days||Standard Deviation|Mean
35178|NCT01519791|Secondary|Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52|"BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).~A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing BRAF-MDQ values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
35179|NCT01519791|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52|"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability.~A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing HAQ-DI values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
35180|NCT01519791|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52|"Normative physical function is defined as HAQ-DI score ≤ 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35277|NCT01519323|Secondary|Best Overall Response Rate (BORR)|BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants who achieved a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper–Pearson.|Up to 2 years|Intent to treat population included all participants enrolled.||percentage of participants||95% Confidence Interval|Number
35181|NCT01519791|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing SDAI values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
35182|NCT01519791|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.~The CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing CDAI values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
35183|NCT01519791|Secondary|Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing DAS28(ESR) values were imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
35184|NCT01519791|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52|"Good response is defined as:~DAS28[ESR] ≤ 3.2 and decrease from Baseline by > 1.2;~moderate response is defined as achievement of one of the following:~DAS28[ESR] ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28[ESR] > 5.1 and decrease from Baseline >1.2."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR).||percentage of subjects|||Number
35185|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:~Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35186|NCT01519791|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35187|NCT01519791|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35188|NCT01519791|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35278|NCT01519323|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to approximately 2 years 11 months|Safety population included all participants who received at least one dose or a partial dose of study treatment.||participants|||Number
35189|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52|"The ACR/EULAR 2011 remission criteria is defined as:~Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35190|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline in the number of tender joints, a 70 %, or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35191|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline in the number of tender joints, a 50 %, or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35192|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35193|NCT01519791|Secondary|Change From Baseline in the Joint Narrowing Score to Week 52|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||units on a scale||Standard Deviation|Mean
35194|NCT01519791|Secondary|Change From Baseline in the Joint Erosion Score to Week 52|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280."|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||units on a scale||Standard Deviation|Mean
35195|NCT01519791|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52|Radiographic non-progression is defined as change in mTSS ≤ 0.5.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||percentage of subjects|||Number
35196|NCT01519791|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.||units on a scale||Standard Deviation|Mean
35197|NCT01519791|Secondary|Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52|Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
36228|NCT01504867|Primary|Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days|ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.|Within seven days from hospital presentation|Intention-to-Treat||participants|||Number
35198|NCT01519791|Primary|Percentage of Subjects in Sustained Remission at Week 52|"Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.~DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.||percentage of subjects|||Number
35199|NCT01519778|Primary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).|24-31 days|Patients receiving any amount of study drug||participants|||Number
35200|NCT01519765|Secondary|Patient Preference|All patients were given a patient satisfaction survey after delivery. They were asked to select their preference for misoprostol intervention type: buccal, vaginal, or either.|Until 72 hours after delivery|All participants were given the survey however incomplete collection was obtained.||participants|||Number
35201|NCT01519765|Secondary|Patient Satisfaction With Buccal Versus Vaginal Misoprostol Administration.|"All patients were given a patient satisfaction survey. Patients were asked to use a Likert scale to rate their experience on the following:~Likert sub-scale: 1 to 5~1=Not at all/ Never to 5= Very Much/ Always~Nausea and vomiting 1=better outcome 5=worse outcome~effectiveness of misoprostol 1=worse outcome 5=better outcome~concerns of misoprostol 1=better outcome 5=worse outcome~overall labor experience 1=worse outcome 5=better outcome Patients will be followed for the duration of their labor(usually up to 72hrs). The satisfaction survey will be conducted after delivery but will evaluate side effects that they recollect in labor."|Until 72 hours after delivery|Patient surveys were requested from all participants however incomplete patient survey collection was obtained.||units on a scale||Full Range|Median
35202|NCT01519765|Secondary|APGARS|"Median (APGAR) score at 5 minutes after delivery. APGAR: Appearance, Pulse, Grimace, Activity, Respiration Apgar scale is determine by evaluating a newborn on 5 categories on a scale from 0 to 2, then summing up the five values.~Score range is 0 to 10. Score above 7 are generally normal. Score below 3 may indicated poor status."|5 minutes after delivery|||score||Full Range|Median
35203|NCT01519765|Secondary|Chorioamnionitis|Percentage of participants affected with chorioamnionitis|Until 48 hours after delivery|||percentage of participants||95% Confidence Interval|Number
35204|NCT01519765|Secondary|Meconium|Percentage of participants who developed meconium was computed. Presence of meconium was evaluated by the delivering physician. P-value was computed using Fisher exact test.|Until delivery|||percentage of participants||95% Confidence Interval|Number
35205|NCT01519765|Secondary|Neonatal Intensive Care Unit (NICU) Admission|"Percentage of participants whose baby was admitted to NICU was computed from time to delivery to time of hospital discharge.~P-value was computed using Fisher Exact test."|Until discharge from hospital|||percentage of participants||95% Confidence Interval|Number
35206|NCT01519765|Secondary|Tachysystole|Fetal heart tracing was reviewed until 4 hours after last misoprostol dose. Percentage of participant with tachysystole were computed. Tachysystole was defined as more than five uterine contractions in 10 minutes. P value was computed using Fisher exact test|Until 4 hours after last misoprostol dose|||percentage of participants||95% Confidence Interval|Number
35207|NCT01519765|Secondary|Tachysystole With Abnormal FHT|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.~Percentage of participants who presented with tachysystole and abnormal fetal heart tracing was computed.~Abnormal fetal heart tracing was defined as category 2 and above. Tachysystole was defined as more than 5 uterine contractions within 10 minutes. P values were computed by Fisher exact test."|Until 4 hours after last misoprostol dose|||percentage of participants||95% Confidence Interval|Number
35208|NCT01519765|Secondary|Abnormal Fetal Heart Tracing (FHT)|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.~Percentage of participants who presented with abnormal fetal heart tracing was computed.~Abnormal fetal heart tracing was defined as category 2 and 3 fetal heart tracing according to standard criteria.~Abnormal fetal heart tracing included any of the following tachycardia, bradycardia without absent variability, minimal variability, absent variability with or without recurrent decelerations, marked variability, prolonged deceleration and recurrent late deceleration, sinusoidal pattern.~P values were computed by Fisher exact test."|Until 4 hours of last misoprostol dose|||percentage of participants||95% Confidence Interval|Number
35209|NCT01519765|Secondary|Artificial Rupture of Membranes (AROM)|Percentage of participants that required AROM|Until delivery|||percentage of participants||95% Confidence Interval|Number
35210|NCT01519765|Secondary|Foley Bulb|Percentage of participants that required foley bulb use.|Until delivery|||percentage of participants||95% Confidence Interval|Number
35211|NCT01519765|Secondary|Pitocin|Percentage of patients that used pitocin during labor. P-values were computed using Fisher exact test.|Until delivery|||percentage of participants||95% Confidence Interval|Number
35212|NCT01519765|Secondary|Failed Induction of Labor|"Percentage of participants who were determined as a failed induction of labor. Failed induction was defined as no cervical change despite 24 hours of pitocin or 12 hours of pitocin after rupture of membranes.~P value was computed by Fisher exact test."|Until delivery|||percentage of participants||95% Confidence Interval|Number
35213|NCT01519765|Secondary|Arrest of Dilation|"Percentage of participants who presented with arrest of dilation. Arrest of dilation was determined by the delivering physician.~P-value was computed using Fisher exact test."|Until delivery|||percentage of participants||95% Confidence Interval|Number
35214|NCT01519765|Secondary|Number of Misoprostol Doses|Number of misoprostol 25 mcg doses used during induction of labor.|Until delivery|||doses||Full Range|Median
35215|NCT01519765|Secondary|Cesarean Delivery Rate|Percentage of participants who underwent a cesarean delivery was computed. P-value was computed using Fisher's exact test.|Until delivery|||percentage of participants||95% Confidence Interval|Number
35216|NCT01519765|Secondary|Rates of Vaginal Delivery|Percentage of participants who delivered vaginally|Until delivery|||percentage of participants||95% Confidence Interval|Number
35221|NCT01519713|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.||Participants|||Number
35222|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
35223|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|Days 0 and 28 post-vaccination|Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
35224|NCT01519713|Secondary|Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Participants|||Number
35225|NCT01519713|Secondary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Participants|||Number
35226|NCT01519713|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.||Participants|||Number
35227|NCT01519700|Secondary|Incidence of Hospitalizations Due to Febrile Neutropenia|Incidence of hospitalizations due to Febrile Neutropenia|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.||participants|||Number
35228|NCT01519700|Secondary|Frequency of Infections|Frequency of infections by cycle and across all cycles|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups.||participants|||Number
35229|NCT01519700|Secondary|Time to Absolute Neutrophil Count Recovery|Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 & Neupogen group, one patient’s time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint.||Days||Full Range|Median
35230|NCT01519700|Secondary|Depth of Absolute Neutrophil Count Nadir|Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation||10^9 cells/L||Standard Deviation|Mean
35231|NCT01519700|Secondary|Number of Days of Fever|Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.|21 weeks/ 6 cycles|PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations.||participants|||Number
35232|NCT01519700|Secondary|Incidence of Febrile Neutropenia|Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)|21 weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.||participants|||Number
35233|NCT01519700|Primary|Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)|21 days (Cycle 1 of chemotherapy treatment)|PP population||Days||Standard Deviation|Mean
35234|NCT01519674|Secondary|Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.|Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0−100 scale with higher scores indicating greater satisfaction.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 545 subjects contributed to the statistical analysis at Week 24.||scores||Standard Error|Least Squares Mean
35468|NCT01516749|Secondary|Change in Dermatology Quality of Life Index (DLQI)|Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life|Baseline, 8 weeks|Patients who completed 8 weeks of therapy||units on a scale||95% Confidence Interval|Mean
35235|NCT01519674|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.|Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.||episodes|||Number
35236|NCT01519674|Secondary|Adverse Events (AEs)|Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.||Events/100 years of patient exposure|||Number
35237|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Overall Mean Increment.|Estimated overall mean post prandial increment after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 557 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
35238|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Dinner.|Estimated mean post prandial increments at dinner after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 550 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
35239|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Lunch.|Estimated mean post prandial increments at lunch after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 548 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
35240|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Breakfast|Estimated mean post prandial increments at breakfast after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 555 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
35241|NCT01519674|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in fasting plasma glucose (FPG)|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 556 subjects contributed to the statistical analysis at Week 24.||mmol/L||Standard Error|Least Squares Mean
35242|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)|Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.||percentage (%) of subjects|||Number
35243|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)|Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.||percentage (%) of subjects|||Number
35244|NCT01519674|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 24 weeks of treatment.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
35245|NCT01519661|Secondary|Time to Use of New Anti-pseudomonal Antibiotic|Time to first use of new anti-pseudomonal antibiotic was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.||Days||95% Confidence Interval|Median
35246|NCT01519661|Secondary|Number of Days of New Anti-pseudomonal Antibiotic Use|The total number of days of new anti-pseudomonal antibiotic use was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Days||Standard Deviation|Mean
35247|NCT01519661|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Percentage of participants|||Number
35248|NCT01519661|Secondary|Time to First Hospitalization Due to Serious Respiratory-related Adverse Events|The day of first hospitalization due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.||Days||95% Confidence Interval|Median
35249|NCT01519661|Secondary|Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Days||Standard Deviation|Mean
35250|NCT01519661|Secondary|Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.||Percentage of participants|||Number
35251|NCT01519661|Secondary|Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa|Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had data at each time point/cycle were analyzed at each time point. The safety set included all participants who received at least one dose of study drug.||ug/mL|||Number
36229|NCT01504854|Secondary|Comparison of the Response to Treatment of Resveratrol Based on ApoE Genotype|CSF Abeta40|Week 52|ITT analyses. Total population and subpopulation of ApoE4 non-carriers.||ng/ml||Standard Deviation|Mean
35252|NCT01519661|Secondary|Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum|Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.|Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had Pa sputum density values at both baseline and the given time point were included in the analysis. The safety set included all participants who received at least one dose of study drug.||log10 Colony Forming Unit (CFU)||Standard Deviation|Mean
35253|NCT01519661|Secondary|Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 – baseline FEF25-75) / baseline FEF25-75) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
35254|NCT01519661|Secondary|Relative Change From Baseline in FVC Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted – baseline FVC % predicted) / baseline FVC % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
35255|NCT01519661|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted – baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had FEV1 percent predicted values at both baseline and the post baseline time points were analyzed at each given time point. The safety set included all participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
35256|NCT01519661|Primary|Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths|Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.|337 days|Safety set: The safety set included all participants who received at least one dose of study drug.||Percentage of participants|||Number
35257|NCT01519648|Primary|The Rate of Invasive Fungal Infections|Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.|6 month|||participants|||Number
35258|NCT01519518|Secondary|Door-to-first Device Time||28 days||||||
35259|NCT01519518|Secondary|Development of Thrombocytopenia||28 days||||||
35260|NCT01519518|Secondary|All Cause Mortality||1 year||||||
35261|NCT01519518|Secondary|For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes||28 days||||||
35262|NCT01519518|Secondary|Stent Thrombosis Rate (ARC Definite or Probable)||28 days|||percentage of total participants|||Number
35263|NCT01519518|Secondary|Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition||28 days|||percentage of total participants|||Number
35264|NCT01519518|Secondary|CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure||28 days||||||
35265|NCT01519518|Primary|Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition||28 days|||percentage of total participants|||Number
35266|NCT01519518|Primary|Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization||28 days|||percentage of total participants|||Number
35279|NCT01519323|Secondary|Area Under the Concentration-Time Curve for Vemurafenib||Pre-dose, 2, 4, 8, 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 22 (each cycle is of 28 days)|Pharmacokinetic (PK) population included all enrolled participants who received at least one dose or a partial dose of study treatment and provided at least one post-dose blood sample for PK analysis.||hour*nanogram per millitre (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
35267|NCT01519466|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).~There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).~The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test."|Day 60 compared to day 1|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.||Units on a scale||Standard Deviation|Mean
35268|NCT01519466|Secondary|HbA1c|"HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).~The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol)."|Day 1 compared with Day 74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.||Percentage of Glycosylated Haemoglobin||Standard Deviation|Mean
35269|NCT01519466|Primary|Time in Target Blood Glucose Range|Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)|Day 1-15 compared with Day 60-74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.||hours per day||Standard Deviation|Mean
35270|NCT01519427|Secondary|Overall Survival|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.||days||Full Range|Median
35271|NCT01519427|Secondary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.||days||Full Range|Median
35272|NCT01519427|Secondary|Changes in Biomarker Expression|Pre-treatment tumor biopsy tissue and blood and day 7-14 tumor biopsy tissue and blood will be examined by immunohistochemistry for expression and phosphorylation of the proteins pERK, pMEK, pAKT, Ki67, pRpS6, CRAF, cyclin D, PDGFr, pPDGFr. IGFr1, and COT/Tp12 for changes from baseline|Before initiation of treatment and at 7-14 days, up to 2 years|This clinical trial was terminated early. The investigators did not perform any biomarker expression analyses.|||||
35273|NCT01519427|Primary|Objective Response|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response.||participants|||Number
35274|NCT01519323|Secondary|Overall Survival (OS)|Overall survival was defined as the time between the date of first treatment to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of their last being known alive. Median overall survival was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until death (2 years)|Intent to treat population included all participants enrolled.||days||95% Confidence Interval|Median
35275|NCT01519323|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the day of first treatment and the first documentation of progressive disease or death. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Participants who were withdrawn from the study without documented progression were to be censored at the date of the last known tumor assessment when the participant was known to be progression free. Median PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until disease progression or death or which ever occur first (2 years)|Intent to treat population included all participants enrolled.||days||95% Confidence Interval|Median
35276|NCT01519323|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the number of participants that achieved a CR, PR or stable disease (SD) (SD for at least 6 weeks) as assessed by investigators according to the RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as at >=30% decrease under baseline of the sum of diameters of all target lesions. SD was defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Up to 2 years|Intent to treat population included all participants enrolled.||percentage of participants|||Number
36254|NCT01502787|Secondary|Blood Pressure During Angiotensin II Infusion||12 weeks after initiation of nebivolol||||||
36255|NCT01502787|Secondary|Blood Pressure During Angiotensin II Infusion||12 weeks after initiation of metoprolol||||||
35280|NCT01519323|Primary|Maximum Tolerated Dose (MTD)/Recommended Dose|The MTD was defined as the dose level at which six evaluable participants had been treated and at most one participant experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 participant experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Up to 28 days of treatment|A MTD could not be determined in this study because of the low number of participants enrolled.|||||
35281|NCT01519284|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity|AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.|8 days|||ng.h/mL||Standard Deviation|Mean
35282|NCT01519284|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days|||ng.h/mL||Standard Deviation|Mean
35283|NCT01519284|Secondary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.|8 days|||hours||Full Range|Median
35284|NCT01519284|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days|||ng/mL||Standard Deviation|Mean
35285|NCT01519245|Secondary|Volume of Blood Loss After 12 Hours|Volume of chest tube loss at 12 hours (assuming the total volume of loss is blood).|12 hours following admission to the Intensive Care Unit|||mL||Standard Deviation|Mean
35286|NCT01519245|Secondary|Volume of Blood Loss at 6 Hours|Volume of chest tube loss at 6 hours (assuming the total volume of loss is blood).|6 hours following admission to the Intensive Care Unit|||mL||Standard Deviation|Mean
35287|NCT01519245|Primary|Number of Units of Packed Red Blood Cells (PRBC) Transfused Following Coronary Artery Bypass Graft Surgery|Research participants were to receive a blood transfusion in the Intensive Care Unit (ICU) post-operatively if hemoglobin reached a nadir of 80g/L, or at the discretion of the intensivist or cardiac surgeon according to patient clinical status. Transfusion was quantified based on the number of units of PRBC received. (1 unit = 1 bag of blood, as prepared by Canadian Blood Services). Clinical status of research participants was followed throughout their duration in the ICU only. Participation in this study ended upon transfer out of the ICU, to the Cardiology Ward.|From ICU admission to transfer to the Cardiology Ward (placebo group = 24.4 hours; trial group = 24.7 hours)|None of the research participants received PRBC transfusion postoperatively in the ICU.||Unit(s) of PRBC|||Number
35288|NCT01519245|Primary|Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood).|According to standard practice, research participants were be transferred to the intensive care unit (ICU) for post-operative monitoring. Measurement of chest tube output began immediately on arrival to the ICU. Hourly measurements were recorded. Data collection ended upon chest tube removal, or return to the operating room for exploratory surgery due to massive blood loss. As per ICU protocol, chest tubes were be removed when blood loss was recorded to be less than 200mL after six consecutive hours.|From ICU admission post-operatively to mediastinal chest tube removal (placebo group = 20.6 hours; trial group = 19.8 hours)|A total of 44 consented participants were randomized. Prior to unblinding, 3 of the randomized participants were withdrawn from the study due to discovery of ineligibility criteria (1 EF <50%, 1 weight <75kg, 1 CABG x 7). Therefore, a total 41 patients were included in final analysis.||mL||Standard Deviation|Mean
35289|NCT01519206|Secondary|Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment|Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.|Baseline to 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) subjects missed the 1 year visit.||Percentage of Participants|||Number
35290|NCT01519206|Secondary|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.|During Ulthera treatment|||Units on a scale||Full Range|Mean
35291|NCT01519206|Secondary|Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.|"Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 60 days, 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) additional subjects missed the 1 year visit.||Percentage of Participants|||Number
35305|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis|The rheumatologist investigator assessed how the subject’s overall arthritis appeared at the time of the visit. This was an evaluation based on the subject’s disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator’s response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
36256|NCT01502787|Secondary|Blood Pressure During Exercise||12 weeks after initiation of nebivolol||||||
35292|NCT01519206|Primary|Improvement in Overall Lifting and Tightening of Skin|Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.|Baseline to 90 days post treatment|Thirty-five (35) subjects were enrolled; 3 were screen failures. Thirty-two (32) subjects received study treatment. Three (3) subjects were lost-to-follow-up.||percentage of participants improved|||Number
35293|NCT01519167|Secondary|Number of Subjects Converted to Alternative Sedation or Anesthetic Therapy Due to Failure of Treatment of Study Drug and Rescue Medication||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||Participants|||Number
35294|NCT01519167|Secondary|Total Amount of Rescue Analgesia (Fentanyl)|Total amount of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.||microgram||Standard Deviation|Mean
35295|NCT01519167|Secondary|Total Amount of Rescue Sedation (Midazolam)|Total amount of rescue sedation (midazolam) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.||milligram||Standard Deviation|Mean
35296|NCT01519167|Secondary|Frequency of Fentanyl Use for Analgesia|Frequency of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure.|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.||Occurrence||Full Range|Median
35297|NCT01519167|Secondary|Frequency of Midazolam Required for Sedation|Frequency of rescue sedation (midazolam) required to maintain a subject within the target sedation range (UMSS score greater than 1 or N-PASS score less than -2).|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.||Occurrence||Full Range|Median
35298|NCT01519167|Secondary|Time to First Dose of Rescue Midazolam From Start of Dexmedetomidine Infusion|Kaplan-Meier estimates of time in minutes to first dose of rescue midazolam from onset of study drug infusion|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||Hours||95% Confidence Interval|Median
35299|NCT01519167|Secondary|Number of Subjects Who Were Adequately Sedated at Least 80% of Time|Subjects who are adequately sedated (UMSS score of 1 to 3 or NPASS score of -5 to -2) at least 80% of the time sedated with the study drug|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
35300|NCT01519167|Secondary|Number of Subjects Who Have Undergone Procedures Without Artificial Ventilation or Intervention||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
35301|NCT01519167|Secondary|Number of Subjects Not Receiving Rescue Midazolam|Number of subjects who did not receive any rescue midazolam for sedation during the study drug infusion.|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
35302|NCT01519167|Primary|Number of Subjects Who Had Success in Sedation|"Success in sedation was defined by a combined endpoint which was the combination of the following:~Subject had adequate level of sedation (University of Michigan Sedation Scale [UMSS] score between 1 to 3 [minimally sedated to deeply sedated] or Neonatal Pain, Agitation and Sedation Scale [N-PASS] score between -5 to -2 [Light sedation]) at least 80% of the time the subject was given the study drug.~Subject had successfully completed the procedure without a need for rescue sedation (Midazolam).~Subject had undergone the procedure without artificial ventilation or intervention to restore baseline or normal hemodynamic status"|From baseline to end of post-treatment period (approximately 24 hours)|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)||participants|||Number
35303|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35304|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)|The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||mg/dL||Standard Deviation|Mean
35740|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||hour||Standard Deviation|Mean
35306|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis|Subjects answered the following question, “Considering the possible effects of the arthritis, how are you feeling today?” The subject’s response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35307|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain|Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35308|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count|Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Swollen joints||Standard Deviation|Mean
35309|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count|Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Tender/painful joints||Standard Deviation|Mean
35310|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35311|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35312|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35313|NCT01519089|Secondary|Joint Pain Assessment (JPA)|The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to “select the number that best describes any joint pain that participant may have experienced over the past 24 hours” with response options ranging from “0-no joint pain” to “10-worst possible joint pain.”|Baseline, Week 4, 16, 28, 52|The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35314|NCT01519089|Secondary|Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Percentage of participants|||Number
35345|NCT01518322|Secondary|Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study|The total number of subjects who reported prior episodes of cough, wheeze, and shortness of breath.|anytime prior to the single study visit|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.||participants|||Number
35315|NCT01519089|Secondary|Work Limitation Questionnaire (WLQ)|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline (BL), Week (W) 4, 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35316|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35317|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week (W) 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35318|NCT01519089|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35319|NCT01519089|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35320|NCT01519089|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||nails||Standard Deviation|Mean
35321|NCT01519089|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35322|NCT01519089|Secondary|Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35375|NCT01517984|Secondary|Percentage of Participants With Donor-Specific Memory Using Elispot|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-randomization|No analyses were performed due to early study closure.|||||
35323|NCT01519089|Secondary|Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported."|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35324|NCT01519089|Secondary|Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Percentage of participants|||Number
35325|NCT01519089|Secondary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35326|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of body surface area (BSA)” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35327|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Units on a scale||Standard Deviation|Mean
35328|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Percentage of participants|||Number
35344|NCT01518322|Post-Hoc|Of the 22 Subjects With a High FeNO (>50ppb Age 12 Years and Above; >35ppb Age Less Than 12 Years)During the Original Study Visit, Number of Subjects Subsequently Treated With Asthma Medications or Diagnosed With Asthma.|A medical record review of the 22 subjects with a high FeNO Value (>50ppb age 12 years and above; >35ppb age less than 12 years)during the original study visit was conducted. The number of subjects who were either diagnosed with asthma or treated with asthma medications is presented.|4 to 6 months after the original study visit.|Of the 162 subjects in the per-protocol population, 22 had a high FeNO (>50ppb age 12 years and above; >35ppb age less than 12 years). A retrospective medical record review was conducted and the number of subjects either diagnosed with asthma or treated with asthma medications is presented.||participants|||Number
36257|NCT01502787|Secondary|Blood Pressure During Exercise||12 weeks after initiation of metoprolol||||||
35329|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
35330|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
35331|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
35332|NCT01519089|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.||Week||95% Confidence Interval|Median
35333|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35334|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35335|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35336|NCT01519089|Primary|Number of Participants With Malignancy Events _Week 0 Through Follow-up|For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist’s report to the central laboratory for a blinded review by a central pathologist.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.||Participants|||Number
35337|NCT01519089|Primary|Number of Participants With Adjudicated Cardiovacular Events|Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.||Participants|||Number
35338|NCT01519089|Primary|Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 16|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35339|NCT01519089|Primary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35340|NCT01519089|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.||Percentage of participants|||Number
35341|NCT01518946|Primary|Time to Onset of Syncope/Near Syncope While on Tilt Table|After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.|1 hour post-dose|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of randomized investigational product and who had at least 1 measurement of the time to onset of syncopal symptoms/near syncope during tilt-table testing.||seconds||Standard Error|Least Squares Mean
35342|NCT01518530|Secondary|Efficacy as Per the NDI-Neck Disability Index|The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented.|6 weeks||||||
35343|NCT01518530|Primary|Occiflex Device Safety|A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.|6 weeks|||Number of adverse effects|||Number
35376|NCT01517984|Secondary|Percentage of Participants With New Donor Specific Antibodies (DSAs)|Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.|6 to 18 months post-randomization|Intent-to-treat||percentage of participants|||Number
36258|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Angiotensin II Infusion||12 weeks after initiation of nebivolol||||||
35346|NCT01518322|Primary|Relationship Between FeNO and the Prescription of ICS in Primary Care Practices|The total number of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.||participants|||Number
35347|NCT01518322|Primary|Relationship Between FeNO and the Diagnosis of Asthma|For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.||participants|||Number
35348|NCT01518270|Secondary|Eyelash Darkness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.|Baseline|All participants with values available.||Units on a scale||Full Range|Mean
35349|NCT01518270|Secondary|Eyelash Thickness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).|Baseline|All participants with values available.||Millimeters squared (mm^2)||Full Range|Mean
35350|NCT01518270|Primary|Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.|Baseline|All participants with values available.||Millimeters (mm)||Full Range|Mean
35351|NCT01518257|Post-Hoc|Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.||Score on a scale||Standard Deviation|Mean
35352|NCT01518257|Post-Hoc|Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Weeks 4, 8 and 12|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.||Score on a scale||Standard Deviation|Mean
35353|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
35354|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
35355|NCT01518257|Secondary|Patient Global Impression of Change Score|The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.|Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure.||Score on a scale||Standard Deviation|Mean
35356|NCT01518257|Secondary|Change From Baseline in WOMAC Physical Function Score|The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
35357|NCT01518257|Secondary|Change From Baseline in WOMAC Pain Score|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
35377|NCT01517984|Secondary|Participant Survival Rate|Number of participants who did not die within the course of this study.|6 to 18 months post-transplantation|Intent-to-treat||participants|||Number
35378|NCT01517984|Secondary|Allograft Survival Rate|Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study.|6 to 18 months post-randomization|Intent-to-treat||participants|||Number
35358|NCT01518257|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score|The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
35359|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants based on the actual treatment received.||Score on a scale||Standard Deviation|Mean
35360|NCT01518244|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).||percentage of participants|||Number
35361|NCT01518244|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).||milllimeters mercury (mmHg)||Standard Deviation|Mean
35362|NCT01518192|Secondary|Selected Subjective Symptoms in Patients and Control Subjects|Comparison of the number of patients and controls with selected 8 symptoms (fatigue, arthralgias, myalgias, headache, paresthesias, dizziness, irritability, or nausea) within the preceding week, irrespective of whether they were new or increased since erythema migrans.|Examination at 12 months|all participants who followed the protocol||participants|||Number
35363|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.|Comparison of the number of patients and controls with new or increased symptoms since erythema migrans at 12 months.|12 months|all participants who followed the protocol||participants|||Number
35364|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 12 months post inclusion|12 months|all participants who followed the protocol||participants|||Number
35365|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 6 months post inclusion|6 months|all participants who followed the protocol||participants|||Number
35366|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 2 months post inclusion|2 months|all participants who followed the protocol||participants|||Number
35367|NCT01518192|Primary|Adverse Events|Number of patients reporting adverse events|at 14 days|All participants who followed the protocol.||participants|||Number
35368|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.|Comparison of the number patients and controls with new or increased symptoms since erythema migrans at 6 months.|6 months|all participants who followed the protocol||participants|||Number
35369|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days|Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion|at 14 days post inclusion|All participants who followed the protocol were eligible for analysis||participants|||Number
35370|NCT01518153|Secondary|Overall Survival (OS)|Overall Survival is defined as the interval between day of transplant and day of death.|Every 3 months until day of death|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.||days||Full Range|Median
35371|NCT01518153|Primary|Success Rate|Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).|100 days|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI. 9 participants did not meet the criteria to receive randomized planned DLI.||participants|||Number
35372|NCT01517984|Secondary|Measurement of Urinary Parameters Before and After Randomization|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 months post-transplantation to 18 months post-randomization|No analyses were performed due to early study closure.|||||
35373|NCT01517984|Secondary|Incremental Change in IF/TA Scores|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-transplant|No analyses were performed due to early study closure.|||||
35374|NCT01517984|Secondary|Percentage of Participants in the Experimental Arm Off Tacrolimus|Participants in the ‘Randomized to Tacrolimus Withdrawal’ group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies.|18 months post-randomization|Intent-to-treat||percentage of participants|||Number
36259|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Angiotensin II Infusion||12 weeks after initiation of metoprolol||||||
35379|NCT01517984|Secondary|Incidence of Acute Rejection|Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the ‘Randomized to Tacrolimus Withdrawal’ group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events.|6 to 18 months post-randomization|Intent-to-treat||participants|||Number
35380|NCT01517984|Secondary|Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation|Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function|6 months post-transplantation, 24 months post-transplantation|Intent-to-treat||mL/min||Standard Deviation|Mean
35381|NCT01517984|Primary|Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization|The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.|IF/TA scores on protocol biopsies obtained at 24 months post-randomization will be compared to those obtained at the time of implantation for this measurement.|No analyses were performed due to early study closure.|||||
35382|NCT01517893|Secondary|Decrease in Serum Chemokines|Determination of the effects of simvastatin treatment on multiple chemokines in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed prior to treatment and periodically while on treatment||||||
35383|NCT01517893|Secondary|Correlation Among Various Outcome Measures for Vitiligo|Comparison of all tested outcome measures to identify the level of correlation among them, including VASI, Sentinel Patch, Investigator's Global Assessment Score, and Patient's Global Assessment Score|Assessed at final study visit, 6 months after randomization||||||
35384|NCT01517893|Secondary|Increase in Patient's Global Assessment Score|Increase in Patient's Global Assessment Scores of 30% or more from baseline to last available visit|Assessed at final study visit, 6 months after randomization||||||
35385|NCT01517893|Secondary|Decrease in CXCR3 Expression on CD8+ T Cells|Determination of the effects of simvastatin treatment on CXCR3 expression in melanocyte-specific, autoreactive CD8+ T cells in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed prior to treatment and periodically while on treatment||||||
35386|NCT01517893|Secondary|Increase in Quality of Life (QoL) Score|Increased quality of life based on end of study questionnaire scores of subjects randomized to treatment with simvastatin versus placebo|Assessed at final study visit, 6 months after randomization||||||
35387|NCT01517893|Secondary|Decrease in Sentinel Patch Area|Decrease in percent depigmentation of sentinel patch lesion from baseline to last available study visit.|Assessed at final study visit, 6 months after randomization||||||
35388|NCT01517893|Secondary|Safety and Tolerability of High-dose Simvastatin Use in Vitiligo Patients.|Monitoring lab values and patient symptoms for evidence of simvastatin toxicity|Assessed at every visit following randomization (monthly for 6 months)||||||
35389|NCT01517893|Secondary|Increase in Investigator's Global Assessment Score|Increase in Investigator Global Assessment Scores of 30% or more from baseline to last available visit|Assessed at final study visit, 6 months after randomization||||||
35390|NCT01517893|Primary|Decrease in VASI Score|Number of participants with 33% decrease in the Vitiligo Area Scoring Index (VASI) from baseline to the last available study visit|Assessed at final study visit, 6 months after randomization|||participants|||Number
35391|NCT01517750|Post-Hoc|Adherence With ENT Surgeries||6 weeks after randomization|||mins||Standard Deviation|Mean
35392|NCT01517750|Post-Hoc|Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries||6 weeks after randomization|||units on a scale||Standard Deviation|Mean
35393|NCT01517750|Secondary|Nasopharyngeal Complaints|"Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 (“no complaints”) to 5 (“very strong). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25."|6 weeks after patient randomization|||units on a scale||Standard Deviation|Mean
35394|NCT01517750|Secondary|Functional Outcome of Sleep Questionnaire (FOSQ)|"FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = I don't do this activity for other reasons, 1=Yes extremely, 2=Yes moderately, 3= Yes a little, 4 = No. Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities."|6 weeks after patient randomization|||units on a scale||Standard Deviation|Mean
35395|NCT01517750|Secondary|Epworth Sleepiness Score (ESS)|The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness|6 weeks after patient randomization|||units on a scale||Standard Deviation|Mean
35396|NCT01517750|Primary|Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.||6 weeks after patient randomization|||minutes||Standard Deviation|Mean
35397|NCT01517529|Secondary|Number of Participants Who Cleared the Virus|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses|9 months|||participants|||Number
35398|NCT01517529|Primary|Number of Participants Who Completed Standard Treatment|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.|9 months|Measure HCV viral load and HCV-specific immune responses at baseline||participants|||Number
36260|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Exercise||12 weeks after initiation of nebivolol||||||
36261|NCT01502787|Primary|Sympathetic Nerve Activity (SNA) During Exercise||12 weeks after initiation of metoprolol||||||
35399|NCT01517412|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.|Baseline, Week 24|mITT population.||Units on a scale||Standard Error|Least Squares Mean
35400|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24|On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
35401|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period|Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
35402|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24|Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
35403|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|Week 24|mITT population.||Percentage of participants|||Number
35404|NCT01517412|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|Baseline, Week 24|mITT population.||kg||Standard Error|Least Squares Mean
35405|NCT01517412|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|Baseline, Week 24|mITT population.||mmol/L||Standard Error|Least Squares Mean
35406|NCT01517412|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|Baseline, Week 24|mITT population.||mmol/L||Standard Error|Least Squares Mean
35407|NCT01517412|Secondary|Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24|Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Week 24|mITT population.||Percentage of participants|||Number
35408|NCT01517412|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug and had both baseline and at least one post-baseline assessment of any primary or secondary efficacy endpoints, irrespective of compliance with study protocol and procedures.||Percentage of hemoglobin||Standard Error|Least Squares Mean
35419|NCT01517373|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 2, 4, 6, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.||percentage of hemoglobin||Standard Deviation|Mean
35409|NCT01517373|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure||participants|||Number
35410|NCT01517373|Secondary|Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||kilogram (kg)||Standard Deviation|Mean
35411|NCT01517373|Secondary|Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant|Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.|Baseline (Day 1) up to Week 14|Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.|||||
35412|NCT01517373|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||events per participant||Full Range|Median
35413|NCT01517373|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||percentage of participants|||Number
35414|NCT01517373|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
35415|NCT01517373|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator’s discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure||participants|||Number
35416|NCT01517373|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data|Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia’s correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure.||participants|||Number
35417|NCT01517373|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.|Week 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure.||percentage of participants|||Number
35418|NCT01517373|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12||Baseline (Day 1), Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
36262|NCT01502787|Primary|Forearm Blood Flow||12 weeks after each specified medication|||ml/min||Standard Deviation|Mean
35420|NCT01517373|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||percentage of hemoglobin||Standard Deviation|Mean
35421|NCT01517295|Secondary|Peak Urine Concentration of Hydromorphone|Analyze the urine concentration of hydromorphone|Up to 4 hours|||ng/mL||Standard Deviation|Mean
35422|NCT01517295|Secondary|Correlation of Plasma PK of Hydrocodone|Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.|1 Month|Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.|||||
35423|NCT01517295|Primary|Peak Plasma Concentration of Hydromorphone|Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.|Up to 6 hours|||ng/mL||Standard Deviation|Mean
35424|NCT01517282|Secondary|Number of New or Enlarging T2 Lesions|T2-weighted magnetic resonance imaging (MRI) tests were performed at Weeks 8, 12, and 16 to assess the number of new or enlarging T2 brain lesions, a sign of MS activity. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 8, 12, and 16 were:~MOR103 0.5 mg/kg: 8,8,8 MOR103 1.0 m/kg: 6,6,6 MOR103 2.0 mg/kg: 7,7,7 Placebo: 6, 4, 5"||Number of new or enlarging T2 lesions|||Number
35425|NCT01517282|Secondary|Number of New T1 Gadolinium-enhancing Lesions|Magnetic resonance imaging (MRI) tests were performed at screening (to confirm subject eligibility) and at Weeks 4, 8, 2, and 16. MRIs at post-screening time points were used to assess the number of new lesions as revealed by gadolinium (Gd) enhancement. Gd-enhanced MRIs reveal new brain lesions reflecting areas of active inflammation. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 4, week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 4, 8, 12, and 16 were:~MOR103 0.5 mg/kg: 8,8,8,8 MOR103 1.0 m/kg: 6,6,6,6 MOR103 2.0 mg/kg: 8,7,7,7 Placebo: 6, 6, 4, 5"||Number of new T1 Gd-enhancing lesions|||Number
35426|NCT01517282|Secondary|Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC|At week 0 (first dose) and week 10 (last dose), serum samples were obtained at pre-dose and at 1, 2, 4, and 336 hours after start of dosing. To calculate the accumulation ratio, the apparent AUC calculated for the last dose was divided by the apparent AUC following the first dose using the described time points for each dosing. Because AUC is a summary outcome, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). Data were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).||ratio of AUC values||Standard Deviation|Mean
35427|NCT01517282|Secondary|Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Tmax values for each patient were calculated based on these data, and the mean Tmax values for the dose cohort are presented here. Because Tmax refers to the time to maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).||hour||Standard Deviation|Mean
35428|NCT01517282|Secondary|Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Cmax values for each patient were calculated based on these data, and the mean Cmax values for the dose cohort are presented here. Because Cmax refers to the maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable, as they represent the concentration of MOR103, but not the Cmax.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).||mg/L||Standard Deviation|Mean
35429|NCT01517282|Secondary|Mean Serum Concentration of MOR103 Over Time|MOR103 serum levels were measured at each visit. At all visits during the dosing period (weeks 0, 2, 6, 8, and 10), serum samples were taken before MOR103 administration (pre-dose) and 1 hour after the dose. In addition, at week 0 (first dose) and week 10 (last dose), additional samples were obtained at 2 hours and 4 hours after MOR103 administration. At visits that followed the dosing period (weeks 12, 14, 16, and 20), a single serum sample was obtained at any time during the visit.|Week 0 (dose 1) to week 20 (end of study)|Pharmacokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data were not available for all patients at each time point.||mg/L||Standard Deviation|Mean
35463|NCT01516879|Secondary|Percent Change From Baseline in LDL-C at Week 12|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 12|Full Analysis set||percent change||Standard Error|Least Squares Mean
35464|NCT01516879|Secondary|Percentage of Participants With an LDL-C Response at Week 52|An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.|Week 52|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
35430|NCT01517282|Secondary|Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples|To assess the potential immunogenicity of MOR103, a central bioanalytical laboratory (Eurofins Medinet BV, Breda, The Netherlands) tested serum samples obtained at baseline and at 3 post-treatment time points (week 14, week 16, and week 20/end of study) for anti-MOR103 antibodies.|Baseline, week 14, week 16, and week 20/end of study|All subjects who received 1 or more dose of placebo or MOR103 (safety population). Data were missing for 1 patient each in the MOR103 1.0 mg/kg and 2.0 mg/kg groups at week 14 and week 16. Data were also missing for 1 patient in the placebo group at all post-baseline timepoints (week 14, 16, and 20).||percentage of participants|||Number
35431|NCT01517282|Primary|Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)|The safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) was assessed by evaluation of the incidence of TEAEs and TESAEs. A full listing of adverse events recorded during this trial can be found in the Adverse Events section. AEs were regarded as treatment emergent if they started on or after the first date of study drug administration or if they were present prior to the first date of study drug administration and increased in severity or relationship to study drug during the study. AEs were coded using MedDRA version 16.1|From the first dose (week 0) to study endpoint (week 20)|All subjects who received 1 or more dose of placebo or MOR103 (safety population).||percentage of participants|||Number
35432|NCT01517178|Primary|Degree of Output Under the Base Plate (Leakage).|Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).|Each test product was assessed for 2 weeks.|||units on a scale|Participants|Standard Deviation|Mean
35433|NCT01517074|Secondary|Step Changes in Scleral Inflammation According to the Standardized Photographic Grading System Developed at National Eye Institute (NEI)||Baseline and Week 52||||||
35434|NCT01517074|Secondary|Number of Participants Who Experience a Substantial Rise in Elevated Intraocular Pressure (IOP)|A substantial rise in intraocular pressure can be defined as ≥10 mmHg change in pressure.|Baseline and Week 52|||participants|||Number
35435|NCT01517074|Secondary|Proportion of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52||||||
35436|NCT01517074|Secondary|Number of Participants Who Tapered Off One or More Systemic Immunosuppressive Medications or Tapered Off Prednisone (≤10 mg) After Week 16|Four (4) out of 5 participants were on immunosuppressive medications at enrollment.|Week 16 and Week 52|||participants|||Number
35437|NCT01517074|Secondary|Number of Participants Who Experienced Systemic Toxicities||Baseline and Week 52|||participants|||Number
35438|NCT01517074|Secondary|Number of Participants Who Experienced Ocular Toxicities||Baseline and Week 52|||participants|||Number
35439|NCT01517074|Secondary|Mean Number of Days Between the First Injection to the Second Injection|For participants who demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection|Baseline and Week 52|||Days||Full Range|Mean
35440|NCT01517074|Secondary|Number of Participants Needing a Second Injection|Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).|Baseline and Week 52|||participants|||Number
35441|NCT01517074|Secondary|Median Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52||||||
35442|NCT01517074|Secondary|Mean Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52||||||
35443|NCT01517074|Secondary|Number of Participants Who Experience a Disease Flare as Defined by a ≥ 1-step Increase in Scleral Inflammation|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)|Baseline and Week 52|||participants|||Number
35444|NCT01517074|Primary|Number of Participants Who Experience at Least 2-step Reduction or Reduction to Grade 0 of Scleral Inflammation in the Study Eye According to the National Eye Institute (NEI) Photographic Scleritis Grading System Within 8 Weeks Post-injection.|"The primary efficacy outcome was a 2-step reduction in scleritis grading out of a scale of 0 to 4+ (where 0.5+ is recognized as an ordinal step between 1+ and 0+).~Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)."|Baseline and Week 8|||participants|||Number
35445|NCT01516970|Secondary|Percentage of Participants Who Developed Detectable HIV Antibodies|Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies (defined as positive) and percentage of participants who had not developed detectable HIV antibodies (defined as negative). Per protocol (PP) population included all participants in mITT (defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|At Month 3|Analysis was performed on PP population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
35446|NCT01516970|Secondary|Worst Sheehan Disability Scale (SDS) Score for the Safety Population|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 inter-related domains: work/school, social and family life, using a rating scale for each item ranging from 0 (not at all) to 10 (extremely).|Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.||units on a scale||Standard Deviation|Mean
35447|NCT01516970|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined to be non-treatment-emergent if the onset date of the AE was clearly before the date of first HIV PEP administration, otherwise it is considered treatment-emergent.|Up to Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.||participants|||Number
35448|NCT01516970|Primary|Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)|Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT [defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person]) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|Up to 30 days|Analysis was performed on PP population.||participants||95% Confidence Interval|Number
35449|NCT01516892|Secondary|Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score|The HIT-6 measures the impact of headache and treatment on the participant’s functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.|Baseline, Week 60, Week 108|Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis.||score on a scale||Standard Deviation|Mean
35450|NCT01516892|Secondary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 60|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.||headache days||Standard Deviation|Mean
35451|NCT01516892|Primary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 108|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.||headache days||Standard Deviation|Mean
35452|NCT01516879|Secondary|Percent Change From Week 12 to Week 52 in LDL-C|Cholesterol was measured by means of ultracentrifugation.|Week 12 and Week 52|The Effect Durability Analysis Set included participants in the FAS who adhered to the scheduled study drug and had nonmissing LDL-C values at Baseline, Week 12 and Week 52.||percent change||Standard Error|Least Squares Mean
35453|NCT01516879|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35454|NCT01516879|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35455|NCT01516879|Secondary|Percent Change From Baseline in Triglycerides at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35456|NCT01516879|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35457|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35458|NCT01516879|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35459|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 52||Baseline and Week 52|Full analysis set||percent change||Standard Error|Least Squares Mean
35460|NCT01516879|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35461|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 52||Baseline and Week 52|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35462|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full Analysis Set||percent change||Standard Error|Least Squares Mean
35469|NCT01516749|Secondary|Change in Quality of Life Assessments|"The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).~The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit? with a scale of 0=no acitivity to 100=maximal activity."|Baseline, 8 weeks|Patients who completed 8 weeks of therapy||units on a scale||95% Confidence Interval|Mean
35470|NCT01516749|Primary|Change in Modified Sartorius Score|"At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5–10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.~Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity."|Baseline, 8 weeks|The 5 patients who completed 8 weeks of therapy||units on a scale||95% Confidence Interval|Mean
35471|NCT01516632|Secondary|Continuous Abstinence at 4-weeks Post-quit|Smoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other|4 weeks post-quit|||participants|||Number
35472|NCT01516632|Secondary|Point Prevalence|A cigarette, even just a puff, within the last 7 days (yes/no).|4-weeks post-quit|||participants|||Number
35473|NCT01516632|Primary|Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations|"Continuous abstinence is defined as 5 or fewer cigarettes smoked since one's quit date. The question was asked based upon West et al., 2005: Have you smoked at all, even just a puff, since [insert quit date]? If yes, the respondent will be probed for how many cigarettes were smoked. Responses will be categorized into one of three options: A) No, not a puff; B) 1-5 cigarettes; C) More than 5 cigarettes.~Self-reported cessation is confirmed by a significant other."|3-months post-quit|||participants|||Number
35474|NCT01516268|Primary|Narcotic Dosage|The total dosage of morphin consumed by the patients in sufentanil or control group.|over 24 hours after surgery|||mgm,.||Standard Deviation|Mean
35475|NCT01516268|Secondary|Pain||24h||||||
35476|NCT01516268|Primary|Narcotic Dosage||24 h||||||
35477|NCT01516034|Secondary|Tolerability Score|The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.|0, 2, 4, 6, 8, 10 weeks (after every treatment)||||||
35478|NCT01516034|Primary|Tattoo Removal Efficiency|"Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:~Scoring by independent dermatologist~Measuring pigment clearance using image analysis"|6 months (termination)|The number of participants that completed follow up.|||||
35479|NCT01516008|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage of participants|||Number
35480|NCT01516008|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.||Scores on a scale||Standard Deviation|Mean
35481|NCT01516008|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values||Scores on a scale||Standard Deviation|Mean
35482|NCT01516008|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.||Scores on a scale||Standard Deviation|Mean
35494|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||h⋅ng-eq/mL||Standard Deviation|Mean
35483|NCT01516008|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage of participants|||Number
35484|NCT01516008|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage of participants|||Number
35485|NCT01516008|Secondary|Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours|Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|Baseline (Day 1) and 12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Percentage Reduction||Inter-Quartile Range|Median
35486|NCT01516008|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|Up to 48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.||Hours||Inter-Quartile Range|Median
35487|NCT01516008|Primary|Sum of Pain Intensity Differences (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.||Scores on a scale||Standard Deviation|Mean
35488|NCT01515943|Secondary|Successful Treatment of Convergence Insufficiency (CI) Based on Signs/Symptoms at 12 Weeks|The proportion of subjects who are successfully treated for CI based on signs/symptoms at the 12-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points since baseline and an 12-week score of < 16 points.|12 weeks after randomization (baseline)|||participants|||Number
35489|NCT01515943|Secondary|Successful Treatment of Convergence Insufficiency (CI) According to Clinical Measures at 12 Weeks|"The proportion of subjects who are successfully treated for CI based on clinical measures at the 12-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:~Near point of convergence (NPC): 12-week/baseline NPC <0.763 and a mean 12-week NPC <6 cm~Positive fusional vergence (PFV): 12-week/ baseline PFV > 1.419 and a mean 12-week PFV > 15 pd"|12-weeks after randomization (baseline)|||participants|||Number
35490|NCT01515943|Secondary|Convergence Improvement at 12 Weeks Since Randomization|"Pairwise treatment group comparisons of the proportion of subjects with improved convergence will be performed at the 12 week visit using logistic regresion, adjusting for baseline covariates. Improvement is based on whether all 3 criteria (below) are met as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline~Near point of convergence (NPC): 12-week/baseline NPC <0.763~Positive fusional vergence (PFV): 12-week/ baseline PFV > 1.419"|12 weeks after randomization (baseline)|||participants|||Number
35491|NCT01515943|Secondary|Successful Treatment of Convergence Insufficiency (CI) for the Near Target Push-up Versus Placebo Group Comparison at 12 Weeks|"The proportion of subjects who are successfully treated for CI at the 12-week visit. Success is defined according to whether all 3 criteria (below) are met as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline and an 12-week score of < 16 points~Near point of convergence (NPC): 12-week/baseline NPC <0.763 and a mean 12-week NPC <6 cm~Positive fusional vergence (PFV): 12-week/ baseline PFV > 1.419 and a mean 12-week PFV > 15 pd"|12 weeks after randomization (baseline)|||participants|||Number
35492|NCT01515943|Primary|Successful Treatment of Convergence Insufficiency (CI) for the Computer-based Therapy Versus Placebo Group Comparison at 12 Weeks|"A treatment comparison of the proportion of subjects who are successfully treated for CI at the 12-week visit using binomial regression, adjusting for baseline covariates of CISS score, mean NPC break, and mean PFV blur. Success is defined according to whether all 3 criteria (below) are met as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline and an 12-week score of < 16 points~Near point of convergence (NPC): 12-week/baseline NPC <0.763 and a mean 12-week NPC <6 cm~Positive fusional vergence (PFV): 12-week/ baseline PFV > 1.419 and a mean 12-week PFV > 15 pd"|12-weeks after randomization (baseline)|||participants|||Number
35493|NCT01515943|Primary|Successful Treatment of Convergence Insufficiency (CI) for Computer-based Therapy Versus Near Target Push-up Group Comparison at 12 Weeks|"A treatment comparison of the proportion of subjects who are successfully treated for CI at the 12-week visit using binomial regression, adjusting for baseline covariates of CISS score, mean NPC break, and mean PFV blur. Success is defined according to whether all 3 criteria (below) are met as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline and an 12-week score of < 16 points~Near point of convergence (NPC): 12-week/baseline NPC <0.763 and a mean 12-week NPC <6 cm~Positive fusional vergence (PFV): 12-week/ baseline PFV > 1.419 and a mean 12-week PFV > 15 pd"|12 weeks after randomization (baseline)|||participants|||Number
35495|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||h⋅ng-eq/mL||Standard Deviation|Mean
35496|NCT01515891|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||hours||Standard Deviation|Mean
35497|NCT01515891|Primary|Maximum Plasma Concentration (Cmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose|||ng-eq/mL||Standard Deviation|Mean
35498|NCT01515865|Primary|Percent of Subjects Who Failed to Maintain a Response|"Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:~The Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by >=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms.~There was an increase in the number of syncopal/near syncopal events or severity of events within 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness."|30 minutes post-dose on Day 16|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of double-blind investigational product.||percentage of participants|||Number
35499|NCT01515696|Post-Hoc|Necrotizing Enterocolitis|necrotizing enterocolitis stage 2a after Bell|End of study|||participants|||Number
35500|NCT01515696|Secondary|Feeding Tolerance- Full Enteral Feedings|full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg|days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg|per protocol||days||Full Range|Median
35501|NCT01515696|Primary|Time to Complete Meconium Evacuation in Days|Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life|days of life until until the complete meconium evacuation from birth up to 40 days of life|per protocol||days of life||Full Range|Median
35502|NCT01515657|Primary|Time to 99% Inhibition of Serum Thromboxane (TxB2)|Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|4 days|Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition||Hours||Standard Deviation|Mean
35503|NCT01515566|Secondary|Effect of Fentanyl on Walk Distance|Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.|Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.|||feet||Standard Deviation|Mean
35504|NCT01515566|Primary|Retention Rate|Retention rate is defined as the percentage of subjects able to complete the study.|Baseline to study completion, up to 100 minutes.|||percentage of participants|||Number
35505|NCT01515566|Secondary|Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea|Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 (“no shortness of breath”) to 10 (“worst possible shortness of breath”) and every 5 minutes during the rest period.|Baseline to 100 minutes for study participation.|||units on a scale||Standard Deviation|Mean
35506|NCT01515540|Primary|"Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents no Pain and 100 Was the Worst Pain Imaginable."|"the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch.~A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful."|2 weeks|based on a literature search.||peak pain intensity||Standard Deviation|Mean
35507|NCT01515488|Secondary|Patient Satisfaction|Custom survey with 4 items capturing satisfaction with Understanding, Ease of Answering Questions, Respect for Privacy, and Overall Feelings. For each item, the lowest possible score was 1 and the highest possible score was 6. For Understanding, the lowest actual score was 2 and the highest actual score was 6. For Ease of Answering Questions, the lowest actual score was 2 and the highest actual score was 6. For Respect for Privacy the lowest actual score was 3 and the highest actual score was 6. For Overall Feelings, the lowest actual score was 3 and the highest actual score was 6. For the (unweighted) average of all 4 items, the lowest possible score was 1 and the highest possible score was 6. The lowest actual score was 3.5 and the highest actual score was 6.0.|Upon completion of triage.|||units on a scale||Standard Deviation|Mean
35508|NCT01515488|Secondary|Accuracy of Medical History|To check for accuracy of medical history information, two RAs approached enrolled parents during the course of their ED visit in the individual patient examination rooms. The RAs conducted a brief face-to-face interview with parents and verified information from the nursing triage summary sheet (for non-kiosk users) and the printout of history sheet from the kiosk users, noting any discrepancies on a Discrepancy Rating Scale. All historical discrepancies were categorized into three groups: major discrepancy, minor discrepancy and no discrepancy.|Upon completion of triage.|||Inaccuracies||Standard Deviation|Mean
35509|NCT01515488|Primary|Triage Time|The time it takes for the patient to be triaged, compared across the kiosk and nurse-initiated triage conditions.|From beginning of triage to completion of triage.|||Seconds||Standard Deviation|Mean
35510|NCT01515423|Secondary|Change From Baseline in Marder Factor Subscale Score at Week 48|5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
35511|NCT01515423|Secondary|Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
35512|NCT01515423|Secondary|Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria|Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.|Weeks 41 to 65|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
35513|NCT01515423|Secondary|Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48|The Personal and Social Performance (PSP) scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
35514|NCT01515423|Secondary|Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
35515|NCT01515423|Secondary|Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
35516|NCT01515423|Primary|Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase|Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.|Up to 48 weeks|Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
35517|NCT01515410|Primary|"The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent OFF Time."|"OFF indicates wearing off motor fluctuations before the next levodopa dose. Percent OFF time is calculated as the total OFF time divided by the total awake time for each day and multiplied by 100.~Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.~Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.~End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.~Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits."|Baseline and 10 days for each of the 2 study periods|Modified Intent-to-treat (ITT) Population||percentage of time||95% Confidence Interval|Least Squares Mean
35518|NCT01515345|Secondary|Probable Stent Thrombosis|"Probable stent thrombosis is considered to have occurred in case of~any unexplained death within the first 30 days.~any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure"|30days|||participants|||Number
35519|NCT01515345|Primary|Any Bleeding Event|"Bleeding classified by the TIMI hemorrhage classification scheme:~Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin of 3 to < 5 g/dL~Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL"|30days|||participants|||Number
35520|NCT01515345|Primary|Definite Stent Thrombosis|"The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis"|30 days|||participants|||Number
35521|NCT01515306|Secondary|Part B: Immunogenicity of Ramucirumab as Monotherapy - Incidence of Anti-Ramucirumab Antibodies||0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug||06/2017||||
35522|NCT01515306|Secondary|Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Incidence of Anti-Ramucirumab Antibodies||-1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug||06/2017||||
35523|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel|Dose-normalized Cmax was calculated from Cmax divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2 of Part A.||micrograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
35524|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2 of Part A.||micrograms*hour/milliliters/milligram||Geometric Coefficient of Variation|Geometric Mean
35525|NCT01515306|Primary|Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion|All participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 1 of Part B.||micrograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
35526|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 2.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
35527|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 1.||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
35528|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 2.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
35529|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 1.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
35559|NCT01514422|Primary|Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)|Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).|baseline and week 8|||units on a scale||Full Range|Mean
35530|NCT01514864|Secondary|Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality|Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 – 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received study drug.||Participants|||Number
35531|NCT01514864|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug||Participants|||Number
35532|NCT01514864|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug||Months||90% Confidence Interval|Median
35533|NCT01514864|Secondary|Progression-free Survival (PFS) Distribution|PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug||Percentage of participants||90% Confidence Interval|Median
35534|NCT01514864|Secondary|Overall Survival|Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received treatment||Months||90% Confidence Interval|Median
35535|NCT01514864|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated.|||||
35536|NCT01514864|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated.|||||
35537|NCT01514760|Secondary|Asthma Control Test™ Scores|"The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5)."|Baseline and eight weeks|All participants and participants with uncontrolled asthma at baseline. The number of participant with uncontrolled asthma 10.||units on a scale||Standard Deviation|Mean
35538|NCT01514760|Secondary|Asthma Self-Efficacy for Adolescent Children|"The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from “not at all sure” (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to “completely sure” (5 points). Total score range from 14-70. The higher score represent a greater degree of self-efficacy. The Cronbach’s α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention)."|Baseline and eight weeks|||units on a scale||Standard Deviation|Mean
35539|NCT01514760|Secondary|Number of Participants That Utilized the Asthma Action Plan|The frequency of utilization of the Asthma Action Plan for acute symptoms among the study population will be measured and compared to responses of daily prompts that will ask participants to record whether they used rescue medication.|Eight weeks|||participants|||Number
35540|NCT01514760|Primary|Mobile Asthma Action Plan (AAP) Usage|Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements.|Eight weeks|||days per week||Full Range|Median
35541|NCT01514734|Primary|Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).|Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|8 weeks|||millimeters mercury (mmHg)||Standard Deviation|Mean
35542|NCT01514630|Primary|HAMD Rating Scores|"Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.|||Units on a scale||Standard Deviation|Mean
35543|NCT01514513|Secondary|Adverse Events|Number of participants with adverse events|15 days|||participants|||Number
35544|NCT01514513|Primary|The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice|No live lice 15 days following initial treatment|15 days|||participants|||Number
35545|NCT01514461|Secondary|Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death||52 weeks|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
35546|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)|Average observed blood concentration measured by (AUC0-24)/24.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||ng/mL||Standard Deviation|Mean
35547|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)||0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||hours||Full Range|Median
35548|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)|The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment||ng/mL *hr||Standard Deviation|Mean
35549|NCT01514461|Secondary|Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax)|Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment||ng/mL||Standard Deviation|Mean
35550|NCT01514461|Secondary|Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12|Post prandial peak triglycerides – maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 – area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours|0-24 hours at Baseline, Week 12|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. For each category, the number of randomized patients who have non-missing values are included in this analysis.||Percent change||95% Confidence Interval|Geometric Mean
35551|NCT01514461|Secondary|Percent Change From Baseline in Fasting Triglycerides||Baseline, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percent change||95% Confidence Interval|Geometric Mean
35552|NCT01514461|Secondary|Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds|Percentage of patients reaching target values of <1000 mg/dL or target values of < 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of patients|||Number
35553|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of participants|||Number
35554|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of participants|||Number
35555|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.||Percentage of participants|||Number
35556|NCT01514461|Primary|Percent Change in Fasting Triglycerides From Baseline to 12 Weeks|Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.|Baseline to 12 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. The number of randomized patients with non-missing fasting triglycerides values at baseline and Week 12 are included in this analysis.||percent change||95% Confidence Interval|Geometric Mean
35557|NCT01514422|Secondary|Changes in Young Mania Rating Scale (YMRS)|Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).|baseline and week 8|||units on a scale||Standard Deviation|Mean
35558|NCT01514422|Secondary|Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan|Measured at baseline and week 8|baseline and week 8|||mmol/L||Standard Deviation|Mean
35560|NCT01514318|Secondary|Harris Hip Score|A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.|10 year|||units on a scale||Standard Deviation|Mean
35561|NCT01514318|Secondary|Western Ontario McMaster Arthritis Index (WOMAC)|Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.|10 year|||units on a scale||Standard Deviation|Mean
35562|NCT01514318|Primary|Survivorship of the Device|The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.|10 year|Subjects who signed the consent form and completed the study paperwork.||participants|||Number
35563|NCT01514292|Primary|CGM Relative Differences to Laboratory Reference|The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.|7 days|||Percentage of difference||Standard Deviation|Mean
35564|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35565|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35566|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35567|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35606|NCT01513902|Primary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
37510|NCT01484912|Secondary|Change in Consumption of Short-acting Nitrates|The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|from baseline (visit 2) through week 6 (visit 5)||||||
35568|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35569|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35570|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35571|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35572|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35573|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35574|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35575|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35576|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35577|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35578|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35579|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35580|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 10|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35581|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 8|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35582|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 4|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35583|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 2|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35584|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
35585|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
35586|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
35587|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
35588|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
35589|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.||Participants|||Number
35590|NCT01514240|Secondary|Cumulative Remission Rate at Week 8|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Percentage of participants||90% Confidence Interval|Number
35591|NCT01514240|Secondary|Cumulative Remission Rate at Week 4|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Percentage of participants||90% Confidence Interval|Number
35592|NCT01514240|Secondary|Cumulative Remission Rate at Week 2|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Percentage of participants||90% Confidence Interval|Number
35593|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 8|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35660|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants who achieved a clinical cure of the initial CDI episode.||Percentage of participants|||Number
35594|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 4|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35595|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 2|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
35596|NCT01514240|Secondary|Remission After 4-week of Treatment|For the secondary efficacy variable “Remission after 4 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Participants|||Number
35597|NCT01514240|Secondary|Remission After 2-week of Treatment|For the secondary efficacy variable “Remission after 2 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Participants|||Number
35598|NCT01514240|Primary|Remission After 8-week of Treatment|For the primary efficacy variable “Remission after 8 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period||Participants|||Number
35599|NCT01514136|Primary|Degree of Leakage|"The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.~The scale was developed by Coloplast A/S"|One week|||units on a scale|Participants|Standard Deviation|Mean
35600|NCT01513902|Secondary|Taste Assessment|Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.|Day 1, Day 5|The analysis population was defined as all participants who had received at least 1 oral solution formulation of tofacitinib.||participants|||Number
35601|NCT01513902|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.||hours||Standard Deviation|Mean
35602|NCT01513902|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.||liter||Geometric Coefficient of Variation|Geometric Mean
35603|NCT01513902|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.||hours||Full Range|Median
35604|NCT01513902|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
35605|NCT01513902|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
37116|NCT01491035|Primary|AUC(0-24h) of Vortioxetine|Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||ng*h/mL||Standard Deviation|Median
35607|NCT01513902|Primary|Number of Participants With Laboratory Test Abnormalities|Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell[RBC] count:<0.8*lower limit of normal [LLN], platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal[ULN], white blood cell [WBC] count:<0.6*LLN></0>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function (total bilirubin: >1.5*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>3.0*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN);Renal Function (blood urea nitrogen, creatinine:>1.3*ULN, uric acid:>1.2*ULN); Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN);Clinical chemistry (glucose <0.6*LLN or >1.5*ULN, creatine kinase:>3.0*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to [>=] 6/High Power Field [HPF]).|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
35608|NCT01513902|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.|Baseline up to 28 days after the last dose of study drug (Day 5)|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
35609|NCT01513902|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'number of participants analyzed (N)' signifies those participants who were evaluable for this outcome measure.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
35610|NCT01513590|Secondary|Number of Treatment Emergent AEs (Adverse Events)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
35611|NCT01513590|Secondary|Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks|Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Data for 15 subjects were excluded, as only subjects exposed for at least 12 weeks were included in this measurement.||participants|||Number
35612|NCT01513590|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data were imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
35613|NCT01513590|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||episodes|||Number
35614|NCT01513590|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||episodes|||Number
35615|NCT01513590|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. At baseline 195 subjects each in IDegAsp BID and BIAsp 30 BID treatment group were analysed.||mmol/L||Standard Deviation|Mean
35616|NCT01513590|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
35679|NCT01512849|Primary|Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284|The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC – urinary glucose excretion) on the preceding day and on the day of administration.|For 24 hours after each administration|||percent of RGR at baseline||95% Confidence Interval|Mean
35617|NCT01513473|Secondary|Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)|Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)|After 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.||%B/T||Standard Deviation|Mean
35618|NCT01513473|Secondary|Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment|Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.|Between week 1 and week 26|Full Analysis Set (FAS) Included all randomised subjects. 1 subject was excluded from the analysis in the IDet arm as he was withdrawn before exposure to trial drug.||pmol/L||Standard Deviation|Mean
35619|NCT01513473|Secondary|Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))|Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment|After 26 weeks and 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects||episodes|||Number
35620|NCT01513473|Secondary|Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))|Episodes of PG >11.1mmol/L (200mg/dL)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.||episodes|||Number
35621|NCT01513473|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 – 07:00] and over the entire day (24 hours)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.||episodes|||Number
35622|NCT01513473|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.||events|||Number
35623|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 52 weeks of treatment.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks.||mmol/L||Standard Deviation|Mean
35624|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks. FPG samples were missing for 9 subjects.||mmol/L||Standard Deviation|Mean
35625|NCT01513473|Secondary|Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 52 weeks of treatments.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
35626|NCT01513473|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
35627|NCT01513460|Secondary|Mean Percentage of Days With Performance of Usual Activities|A ‘day able to perform usual daily activities’ was defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of ‘days able to perform usual daily activities’ was derived and analyzed using a similar mixed model as specified for primary analysis as for the percentage of nights with ‘no nighttime awakenings’.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage of days||Standard Error|Mean
35628|NCT01513460|Secondary|Mean Percentage of Nights With 'no Nighttime Awakenings'|A night with 'no nighttime awakenings' is defined from diary data as any night where patient did not wake up due to symptoms. Total number of nights with 'no nighttime awakenings' over treatment period was divided by total number of nights where diary recordings have been made in order to derive percentage of 'no nighttime awakenings' which will be summarized by treatment and analyzed using a similar mixed model as specified for primary analysis. Diary data recorded during the 7 day run-in period was used to calculate baseline percentage of nights 'no nighttime awakenings'.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage of nights||Standard Error|Mean
35629|NCT01513460|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use|The total number of puffs of rescue medication used over the last 12 h recorded in the morning (nighttime use) and in the evening (daytime use) over the full 12 weeks was divided by the total number of days with non-missing rescue data to derive the mean daytime and nighttime number of puffs of rescue medication. Change from baseline in the mean daytime and nighttime number of puffs of rescue medication was analyzed as for the change from baseline in the mean daily number of puffs of rescue medication.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.||puffs of rescue medication||Standard Error|Mean
35630|NCT01513460|Secondary|Change From Baseline in Total Score of the St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment|SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest is 100. Higher values corresponded to greater impairment in quality of life. An analysis model included terms for treatment, baseline total SGRQ score, FEV1 and baseline smoking status. The model also contained as fixed effects the baseline total SGRQ score, FEV1 prior to inhalation of short acting bronchodilator, FEV1 post inhalation of short acting bronchodilator and stratification factors as covariates. A negative change from baseline indicates improvement.|12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.||units on a scale||Standard Error|Mean
35631|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.||Liters||Standard Error|Mean
35632|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.||Liters||Standard Error|Mean
35633|NCT01513460|Primary|Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 12 weeks|Participants from the per-protocol set (PPS), who had values at both baseline and week 12, were included in the analysis. The PPS included all randomized participants who had at least one dose of study drug and who were without any major protocol or non-protocol deviations.||liters||Standard Error|Mean
35634|NCT01513447|Secondary|Total Local Anesthetic Consumption|It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.|24 hours|||milliliters||Standard Deviation|Mean
35635|NCT01513447|Primary|Number of Participants With Breakthrough Back Labor Pain|It is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.|within 24 hours|||participants|||Number
35636|NCT01513330|Primary|Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)|Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.|14 days|||points on a scale|Participants|Standard Deviation|Mean
35637|NCT01513317|Secondary|Median Number of Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) During the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants who completed Week 13 unblinding||RBC Transfusions||Full Range|Median
35638|NCT01513317|Secondary|Mean Changes From Baseline in Percentages of Bone Marrow Blast Cells at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13||Percentage of Bone Marrow Blast Cells||Standard Deviation|Mean
35639|NCT01513317|Secondary|Percentage of Participants Who Did Not Require a Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) in the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants||Percentage of Participants|||Number
35640|NCT01513317|Secondary|Percentage of Participants Achieving Hemoglobin Improvement (≥1.5 g/dL Increase From Baseline) Unrelated to Red Blood Cell (RBC) Transfusion at Week 13||Week 13|Intent-to-treat population: Included all randomized participants||Percentage of Participants|||Number
35641|NCT01513317|Secondary|Change From Baseline in the Mean Hemoglobin Concentrations at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13||g/dL||Standard Deviation|Mean
35642|NCT01513317|Primary|Percentage of Participants Who Achieved a Reduction in Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS)|Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.|Up to Week 13|Intent-to-treat population: Included all randomized participants||Percentage of participants|||Number
35680|NCT01512849|Primary|Effect of Renal Function on Urinary Glucose Excretion of TA-7284||For 24 hours after each administration|||g||95% Confidence Interval|Mean
35681|NCT01512849|Primary|Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284||For 72 hours after each administration|||ng･h/mL||Standard Deviation|Mean
35643|NCT01513291|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Percentage of participants||95% Confidence Interval|Number
35644|NCT01513291|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Percentage of participants||95% Confidence Interval|Number
35645|NCT01513291|Secondary|Mean Change From Baseline in Monthly Headache Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Days/month||Standard Error|Least Squares Mean
35646|NCT01513291|Primary|Percentage of Participants Discontinued From Study Medication Due to an Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.||Percentage of participants|||Number
35647|NCT01513291|Primary|Percentage of Participants With One or More Adverse Events|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.||Percentage of participants|||Number
35648|NCT01513291|Primary|Mean Change From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.||Days/month||Standard Error|Least Squares Mean
35649|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Compromised Immunity|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Compromised immunity is an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|12 weeks|Treated participants with compromised immunity||Percentage of participants|||Number
35650|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those 65 Years and Older|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants 65 years and older.||Percentage of participants|||Number
35682|NCT01512849|Secondary|Clinical Laboratory Tests|Change from baseline in Clinical laboratory tests|For 72 hours after each administration||||||
35683|NCT01512849|Secondary|Vital Signs|Change from baseline in Vital signs (BP, PR and BT)|For 72 hours after each administration||||||
35684|NCT01512849|Secondary|12-lead Electrocardiogram (ECG)|Change from baseline in ECG parameters|For 72 hours after each administration||||||
35651|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Participants with clinically severe CDI have a Zar Score greater than or equal to 2 points based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2) body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dl (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|12 weeks|Treated participants with clinically severe CDI||Percentage of participants|||Number
35652|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. An epidemic strain includes ribotypes 027, 014, 002, 001, 106 or 020.|12 weeks|Treated participants with an epidemic strain||Percentage of participants|||Number
35653|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. The 027 ribotype is a more virulent, epidemic strain responsible for several outbreaks of disease associated with an increased risk of severity and mortality.|12 weeks|Treated participants with the 027 ribotype||Percentage of participants|||Number
35654|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants with a history of CDI in the past 6 months.||Percentage of participants|||Number
35655|NCT01513239|Primary|Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 24 hours|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
35656|NCT01513239|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
35657|NCT01513239|Primary|Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
35658|NCT01513239|Primary|Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
35659|NCT01513239|Primary|Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK- 3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.||Percentage of participants|||Number
35685|NCT01512849|Secondary|Adverse Events|Incidence and severity of AEs|Upto approximately 14 days after last administration||||||
35661|NCT01513239|Secondary|Percentage of Participants With Global Cure|Global cure is defined as the clinical cure of the initial CDI episode with no CDI recurrence through Week 12. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.||Percentage of participants|||Number
35662|NCT01513239|Primary|Percentage of Participants With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The (Full Analysis Set) FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.||Percentage of participants|||Number
35663|NCT01513148|Secondary|Temperature (Degrees C)|Change in superficial skin temperature (degrees C) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment|||Degrees Celsius||Standard Deviation|Mean
35664|NCT01513148|Secondary|Negative Peak Latency (Milliseconds)|Change in negative peak latency (ms) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment|||ms||Standard Deviation|Mean
35665|NCT01513148|Primary|Nerve Conduction Velocity (Meters Per Second)|Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment|||m/s||Standard Deviation|Mean
35666|NCT01513122|Secondary|Mean Glucose Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||mmol/L||95% Confidence Interval|Mean
35667|NCT01513122|Secondary|Mean Total Cholesterol Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||mmol/L||95% Confidence Interval|Mean
35668|NCT01513122|Secondary|Mean Triglycerides Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||mmol/L||95% Confidence Interval|Mean
35669|NCT01513122|Secondary|Mean Total Body Fat Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||kg||95% Confidence Interval|Mean
35670|NCT01513122|Primary|Mean Limbs Fat Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||percentage of limb fat change||95% Confidence Interval|Mean
35671|NCT01513122|Primary|Mean Bone Mineral Density Changes Over 48 Weeks as Measured by DXA Scan||May 2013|||percentage of BMD change||95% Confidence Interval|Mean
35672|NCT01512979|Secondary|Change From Baseline in FPG by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC, Observed Cases||mg/dL||Standard Error|Mean
35673|NCT01512979|Secondary|Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment|The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.||participants|||Number
35674|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.||participants|||Number
35675|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.||participants|||Number
35676|NCT01512979|Secondary|Change From Baseline in HbA1c by Visit Over Time|HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC (observed cases)||percent||Standard Error|Mean
35677|NCT01512979|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment|The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 24 weeks|Patients from PPCC (LOCF)||mg/dL||Standard Error|Mean
35678|NCT01512979|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c|Baseline and 24 weeks|Per Protocol completers cohort (PPCC): All patients randomised, treated with at least 1 dose of study drug, with a baseline HbA1c value without important protocol violations and who completed 24 weeks of treatment, were not treated with rescue medication and have an HbA1c measurement after 24 weeks of treatment.||percent||Standard Error|Mean
35686|NCT01512849|Primary|Effect of Renal Function on Maximum Plasma Concentration of TA-7284||For 72 hours after each administration|||ng / mL||Standard Deviation|Mean
35691|NCT01512745|Primary|Progression Free Survival(PFS)|Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|30 months|||month||95% Confidence Interval|Median
35692|NCT01512368|Secondary|Change From Baseline Fasting Glucose Acutely and at Two Weeks|Serum measurement of glucose was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||mg/dL||Standard Deviation|Mean
35693|NCT01512368|Secondary|Change From Baseline Total Adiponectin Acutely and at Two Weeks|Serum measurement of total adiponectin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||ng/mL||Inter-Quartile Range|Median
35694|NCT01512368|Secondary|Change From Baseline Leptin Acutely and at Two Weeks|Serum measurement of leptin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||ng/mL||Inter-Quartile Range|Median
35695|NCT01512368|Secondary|Change From Baseline Epinephrine Acutely and at Two Weeks|Serum measurement of epinephrine was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report (5), we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||pg/mL||Inter-Quartile Range|Median
35696|NCT01512368|Secondary|Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks|Serum measurement of free fatty acids (FFAs) was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.||mg/dL||Inter-Quartile Range|Median
35697|NCT01512368|Primary|Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks|Serum measurement of FGF21 using human ELISA kit was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated. All participants were analyzed.||ng/L||Inter-Quartile Range|Median
35698|NCT01512160|Secondary|Supine Pulse Rate|Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.||beats per minute||Standard Deviation|Mean
35699|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.||beats per minute||Standard Deviation|Mean
35700|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia’s formula (QTcF = QT divided by cube root of RR interval).|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.||milliseconds||Standard Deviation|Mean
35701|NCT01512160|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)|Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.||mmHg||Standard Deviation|Mean
37948|NCT01478256|Secondary|Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics|Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis|Three weeks|||participants|||Number
35702|NCT01512160|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormality|Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
35703|NCT01512160|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
35704|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||mcg*hr/mL||Standard Deviation|Geometric Mean
35705|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||microgram*hour per milliliter (mcg*h/mL)||Standard Deviation|Geometric Mean
35706|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||hours||Full Range|Median
35707|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
35708|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
35709|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
35710|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||hours||Full Range|Median
35711|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
35712|NCT01512160|Secondary|Participant Satisfaction Questionnaire|Participant's response to 2 questions about “how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)” was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.||participants|||Number
35713|NCT01512160|Secondary|Participant Global Evaluation of Study Medication|Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.||participants|||Number
35714|NCT01512160|Secondary|Number of Participants With Rescue Medication|Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||participants|||Number
35715|NCT01512160|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.|1.5 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||hours||90% Confidence Interval|Median
35716|NCT01512160|Secondary|Time to Onset of First Meaningful Pain Relief (PR)|Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||hours||90% Confidence Interval|Median
35717|NCT01512160|Secondary|Time to Onset of First Perceptible Pain Relief (PR)|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||hours||90% Confidence Interval|Median
35718|NCT01512160|Secondary|Total Pain Relief (TOTPAR) Score From 0 to 24 Hours|TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF.||units on a scale*hour||Standard Error|Least Squares Mean
35719|NCT01512160|Secondary|Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.|0 to 6, 0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF.||units on a scale*hour||Standard Error|Least Squares Mean
35720|NCT01512160|Secondary|Time-specific Pain Intensity Difference (PID) Score|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.|15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.||units on a scale||Standard Deviation|Mean
35721|NCT01512160|Secondary|Time-specific Pain Relief (PR) Score|PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.|0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.||units on a scale||Standard Deviation|Mean
35722|NCT01512160|Secondary|Number of Participants With Peak Pain Relief (PPR)|PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.||participants|||Number
35723|NCT01512160|Primary|Total Pain Relief (TOTPAR) Score From 0 to 6 Hours|TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 6 hours|Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).||units on a scale*hour||Standard Error|Least Squares Mean
35724|NCT01512108|Secondary|Change in FPG From Baseline to Week 52|Estimated mean change from baseline in FPG after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.||mmol/L||Standard Error|Mean
35725|NCT01512108|Secondary|Change in HbA1c From Baseline to Week 52|Estimated mean change in HbA1c from baseline after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.||percentage of glycosylated haemoglobin||Standard Error|Mean
35726|NCT01512108|Secondary|Number of Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).|Week 0 to Week 52|Safety analysis set includes all subjects who received at least one dose of the trial product.||episodes|||Number
37949|NCT01478256|Primary|Improvement in Signs and Symptoms of Blepharitis|Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics|Four weeks|||participants|||Number
35727|NCT01512108|Primary|Incidence of Treatment Emergent Adverse Events (AEs)|Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.|Week 0 to Week 52 + 7 days|Safety analysis set included all subjects who received at least one dose of the trial product.||Events/100 years of patient exposure|||Number
35728|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation|Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"For this analysis, the subject who was taking warfarin and aspirin was included in both the Pennsaid, warfarin group and the Pennsaid, aspirin and/or clopidogrel group, and the subject who was taking dabigatran and aspirin was included in both the Pennsaid, dabigatran group and the Pennsaid, aspirin and/or clopidogrel group."||Seconds||Full Range|Mean
35729|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)|PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."||Seconds||Full Range|Mean
35730|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)|INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."||ratio||Full Range|Mean
35731|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)|PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."||seconds||Full Range|Mean
35732|NCT01511809|Secondary|Efficacy and Safety|"Proportion of pts with confirmed virological and treatment failure at w96. Change in CD4 cell counts.~Occurrence of viral resistance to atazanavir in pts with confirmed virologic failure.~Proportion of pts with adverse events, with ≥grade 2 adverse events or abnormal laboratory tests, proportion of pts with side effects leading to discontinuation.~Body fat redistribution and vertebral and femoral bone mineral density. Adherence changes; changes in HIV-associated neurocognitive disorders. Difference in levels of activated Tcells and pro-inflammatory cytokines between treatment groups."|week 96||||||
35733|NCT01511809|Primary|Proportion of Patients With Treatment Failure (TF)|Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA <50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success).|Up to week 48|||percentage of patients|||Number
35734|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)||Pre abiraterone dose on Day 1 of Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||ng/mL||Standard Deviation|Mean
35735|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)|Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval.|0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||ng*h/mL||Standard Deviation|Mean
35736|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||hour||Full Range|Median
35737|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.||ng/mL||Standard Deviation|Mean
35738|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||L/m^2||Standard Deviation|Mean
35739|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||L/h/m^2||Standard Deviation|Mean
37950|NCT01478087|Primary|Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 days post-treatment|||percentage of device related SAE|||Number
35741|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose|5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.||ng*h/mL||Standard Deviation|Mean
35742|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on pharmacokinetic (PK) population which included all participants who received at least 1 treatment. Pre-dose samples from 3 participants of Phase 2, were above lower limit of quantification (LLOQ) (1.00 ng/mL). Hence, those participants were excluded from analysis.||ng/mL||Standard Deviation|Mean
35743|NCT01511536|Secondary|Phase 2: Overall Survival|Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|From baseline up to death or study cut-off (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.||months||95% Confidence Interval|Median
35744|NCT01511536|Secondary|Phase 2: Percentage of Participants With Objective Response|Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters).|Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)|Efficacy/activity population. Number of participants analyzed=participants with measurable disease at baseline.||percentage of participants||95% Confidence Interval|Number
35745|NCT01511536|Secondary|Phase 2: PSA Progression Free Survival|"Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.~Analysis was performed by Kaplan Meire method."|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.||months||95% Confidence Interval|Median
35746|NCT01511536|Secondary|Phase 2: Objective Progression Free Survival (PFS)|"Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:~1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.~Analysis was performed by Kaplan-Meier method."|From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5|Analysis was performed on efficacy/activity population.||months||95% Confidence Interval|Median
35747|NCT01511536|Primary|Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population included all participants who had received at least 2 cycles of the study drug in Phase 2, and had a baseline and at least one post-baseline assessment for the efficacy variable of interest.||percentage of participants||95% Confidence Interval|Number
35748|NCT01511536|Primary|Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate|MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.|Up to Cycle 2 of Phase 1 (up to 42 days)|Analysis was performed on DLT evaluable population defined as all participants who received the first 2 cycles, unless they discontinued the study drug during the first 2 cycles for a DLT.||mg/m^2|||Number
35961|NCT01508130|Secondary|Number of Participants With Safety-related Dose Reductions|The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.||participants|||Number
35749|NCT01511315|Secondary|Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36|The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).||percentage of participants|||Number
35750|NCT01511315|Secondary|Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36|The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).||percentage of participants|||Number
35751|NCT01511315|Secondary|Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline|The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
35752|NCT01511315|Secondary|Change in Psoriasis Quality of Life – 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline|The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient’s own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
35753|NCT01511315|Secondary|Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline|The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)|Baseline, 36 Weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Deviation|Mean
35754|NCT01511315|Secondary|Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline|The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 12 and 24 weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
35755|NCT01511315|Primary|Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.|The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 36 weeks|Only participants who completed the study were included in this analysis (n=32).||units on a scale||Standard Error|Mean
35756|NCT01511107|Secondary|The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product|Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.||participants|||Number
35757|NCT01511107|Secondary|The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.||participants|||Number
35816|NCT01510457|Primary|PamSys Actigraph Data|We used a body worn sensor (PAMSys™, Biosensics, LLC, MA)(25-27) embedded in a comfortable t-shirt at the sternal level. Participants wore the PAMSys after the visit for 48 hours. The device provides values related to subjects spontaneous physical activity including percentage of time standing and walking. These variables provide different indexes of participants’ level of activity and activity organization, and were reported by subjects with KOA pain as relevant.|48 hours after visit 3|||percentage of activity (over 48 hours)||Standard Error|Mean
37951|NCT01478087|Primary|Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 Days Post Treatment|||percentage of procedure related SAE|||Number
35758|NCT01511107|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14|"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. The parent rated each of these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2, and recorded the ratings in a diary. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. For instances in which the participant was declared a treatment failure, scores are included up to, but not including the day of the failure. Otherwise, scores day 6 to day 14 are included."|From day 6 of administration of study product until day 14 for all episodes|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score from day 6 of administration of study product to day 14. The scores were based on diaries completed at home by the child's parent.||AOM-SOS score||Standard Deviation|Mean
35759|NCT01511107|Secondary|The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season|Systemic antibiotics include the study product, Amoxicillin-Clavulanate, dispensed for either 10 or 5 days and various concomitant medications, i.e. Amoxicillin, Amox/Clav, Azithromycin, Cefdinir, Cefpodoxime, Ceftriaxone, Erythromycin, Trimethoprim-Sulfamethoxazole, Omnicef, Augmentin, Azithromycin, Cefazolin, Clarythromycin and Ciprofloxacin.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible.||days||Standard Deviation|Mean
35760|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses by the number of months of follow-up."|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.||recurrences/relapses per months followed||Standard Deviation|Mean
35761|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses within 60 days of enrollment by the number of months of follow-up within 60 days of enrollment."|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.||recurrences/relapses per month||Standard Deviation|Mean
35762|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children completing the study.||participants|||Number
35763|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up greater than or equal to day 60.||participants|||Number
35764|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.||recurrence|Recurrences||Number
35765|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.||participants|||Number
35766|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.||recurrence|Recurrences||Number
35979|NCT01508013|Primary|Indoor Tanning Willingness|Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).|12 months|Adolescent females aged 12-18 years old that expressed interest in indoor tanning in the future.||units on a scale||Standard Deviation|Mean
35767|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.||participants|||Number
35768|NCT01511107|Secondary|The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children with at least one follow-up, nonillness visit, with a nasopharyngeal (NP) culture which is either positive (+) for >=1 penicillin nonsusceptible pathogens or positive (+) only for >=1 penicillin susceptible pathogens or pathogen negative (-).||Visit|Visits||Number
35769|NCT01511107|Secondary|The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 365|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is either pathogen negative or positive only for >=1 susceptible pathogen and a NP culture at some time over the course of followup.||participants|||Number
35770|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) for >=1 nonsusceptible pathogen & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||recurrence|Recurrences||Number
35771|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.6.|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is positive (+) for one or more nonsusceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||participants|||Number
35788|NCT01510834|Secondary|Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)|The PSS is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in the past month. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are of a general nature and relatively free of content specific to any subpopulation. Internal consistency reliability of the PSS has been shown to be moderate (Cronbach alpha coefficient =.78) and that it has good test-re-test reliability. Scores can range from 0-40 as items are scored 1-4 points each. A higher score indicates more stress, so a negative change from baseline (T1)to 3-month follow-up (T3) is a better outcome.|Change in PSS score from baseline (T1) to final 3 mos. follow-up (T3)|All participants completing all 3 time points of the study.||units on a scale||Standard Deviation|Mean
37958|NCT01478009|Secondary|Total Number of Days of Symptoms and Duration of All Colds|Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds|up to 12 weeks||||||
35772|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.9.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) only for one or more susceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||recurrence|Recurrences||Number
35773|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.2.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is positive only for >=1 susceptible pathogen & a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||participants|||Number
35774|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||recurrence|Recurrences||Number
35775|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.3.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.||participants|||Number
35776|NCT01511107|Secondary|The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit|"Proportion of AOM recurrences resulting in treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of the recurrence, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the AOM recurrence was diagnosed until day 21 of the recurrence. The mean day for this visit was 13.3.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit following an AOM recurrence.||recurrence|Recurrences||Number
35812|NCT01510457|Primary|Pain Visual Analogue Scale|Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on a 100mm pain scale||Standard Deviation|Mean
35813|NCT01510457|Primary|Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10)|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on the depression scale||Standard Deviation|Mean
35777|NCT01511107|Primary|The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM|"Proportion of children initially diagnosed with AOM who experience treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of randomization, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the tympanic membrane (TM) or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2.|The analysis was intent to treat (ITT). The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit.||participants|||Number
35778|NCT01511016|Primary|Rate of Net Lipolysis|Rate of net lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment||mmol FFA/kg/h||Standard Error|Mean
35779|NCT01511016|Secondary|Insulin Levels After Oral Glucose Challenge.|An oral glucose tolerance test was performed to measure endogenous insulin response. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a clinical test of endogenous insulin response to glucose i.e., an endocrine test. Although multiple time points are used in this test, the outcome is a single value, i.e., an area-under-the-curve for insulin.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.||microU/mL||Standard Error|Mean
35780|NCT01511016|Secondary|Glucose Levels After Glucose Challenge|An oral glucose tolerance test was performed. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a standard clinical test of glucose tolerance. i.e., a test for diabetes and pre-diabetes. Although multiple time points are used in this test, the outcome is a single value, either a blood glucose level after 2 hours or an area-under-the-curve. In this study we are reporting the area-under-the-curve.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.||mg/dL||Standard Error|Mean
35781|NCT01511016|Secondary|Fasting Plasma Non-HDL-C|Fasting plasma non-HDL-cholesterol was calculated from measured total cholesterol and HDL cholesterol.|4 months after treatment.|Number of subjects in each group remaining after 4 months of treatment.||mg/dL||Standard Error|Mean
35782|NCT01511016|Secondary|Rates of Fatty Acid Oxidation|Rates of fatty acid oxidation were measured in breath samples following stable isotope infusions of 13C-labeled palmitate.|4 months after treatment|Number of subjects in each group remaining at the end of 4 months of treatment.||mmol FFA/kg/h||Standard Error|Mean
35783|NCT01511016|Primary|Rate of Total Lipolysis|Rate of total lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment.||mmol FFA/kg/h||Standard Error|Mean
35784|NCT01510912|Other Pre-specified|Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination|||units on a scale||Standard Deviation|Mean
35785|NCT01510912|Other Pre-specified|Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination|||units on a scale||Standard Deviation|Mean
35786|NCT01510912|Primary|Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.|Baseline to Week 52/Early Termination|||participants|||Number
35787|NCT01510834|Secondary|Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)|The PHQ-9 is the self-administered depression module of the Patient Health Questionnaire that assesses common mental disorders. Eight of the 9 items in the scale are included in the Depression Prevention Assessment and is also known as the PHQ-8. Item 9, which assesses suicidality has been omitted in the online version. The PHQ-8 has been shown to have a sensitivity of 81% and specificity of 99% for scores 15 and above in diagnosing major depression, with a positive predictive value of 94%. Scores range from 0 to 24, with 10-14 indicating minor depression, 15-19 moderately severe major depression, and >19 indicating sever major depression. An initial drop of 5 points is considered adequate treatment response for 3 counseling sessions over 4-6 weeks. A higher score indicates more depression, so a reduction in score from baseline (T1) to 3-month follow-up (T3) is a better outcome.|Change in PHQ-8 score from baseline (T1) to final 3 mos. follow-up (T3)|Those participants who completed all 3 time points.||units on a scale||Standard Deviation|Mean
35814|NCT01510457|Primary|Pain Disability Index (PDI)|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on a disability scale||Standard Deviation|Mean
35789|NCT01510834|Secondary|Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)|"The QOLS contains 16 items that represent five conceptual domains of quality of life. QOLS was developed with more consideration to cultural diversity and individual perspectives than other commonly used measures. It uses a unique 7-item Likert scale that allows responses regarding different aspects of life to range from delightful to terrible. It has been found to be internally consistent with alpha from .82 to .92 and showed high test-retest reliability over 3-weeks (r = 0.78 to r = 0 .84). The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Previous validation research showed that patients who participated in a treatment program and rated their symptoms as improved by 60% or gained on average 7 to 8 points on the QOLS total score. A higher QOLS score indicates better quality of life, therefore, a positive score change is a better outcome."|Change in QOLS score from baseline (T1) to final 3 mos. follow-up (T3)|Participants completing all 3 study time points.||units on a scale||Standard Deviation|Mean
35790|NCT01510834|Primary|Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)|Developed by researchers at the VA National Center for PTSD, PCL is a self-report questionnaire that consists of 17 questions that map directly onto DSM-IV criteria for PTSD. Respondents are asked how often they have been bothered by each symptom in the past month on a 5-point Likert scale (1=not at all to 5=extremely). Previous research has shown internal consistency coefficients were high for the total scale (.97) and for each subscale (.92 - .93). Test-retest reliability over 2-3 days was shown to be .96. Scores can range from 17-85, with a score of 48 typically indicating PTSD in military populations. The National Center for PTSD recommends using 5 points as a minimum threshold for determining whether an individual has responded to treatment and 10 points as a minimum threshold for determining whether the improvement is clinically meaningful. A higher score indicates more PTSD symptoms, therefore, a score reduction from T1 to T3 is a better outcome than an increase.|Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3)|57 completing all time points for intervention and assessment.||units on a scale||Standard Deviation|Mean
35791|NCT01510769|Secondary|Quality of Life|Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient’s level of functional ability with items scores ranging from 0-3 with 0 being the least disability.|12 Months|Intent-to-Treat Population||Proportion of Subjects|||Number
35792|NCT01510769|Secondary|Complete or Partial Response of at Least One Tophus|Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12|12 Months|Intent-to-Treat Population||Proportion of Subjects|||Number
35793|NCT01510769|Secondary|Complete Resolution of at Least One Target Tophus|Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12|12 Months|Intent-to-Treat Population||Proportion of Subjects|||Number
35794|NCT01510769|Primary|Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6|Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6|6 months, analysis after all subjects complete 12 months|Intent-to-Treat Population||Proportion of Subjects|||Number
35795|NCT01510756|Secondary|Safety and Tolerability|Frequency, severity and relatedness of adverse events|3 months|zero participants analyzed due to termination of study|||||
35796|NCT01510756|Secondary|To Determine the iwCLL-WG Defined Overall Response Rate (ORR) - Complete Response (CR) and Partial Responses (PR) to 3 Cycles of Sorafenib Therapy and Following the Completion of All Therapy.|A response assessment must be performed 2 months following completion of therapy to document responses, including a bone marrow if in clinical response (CR) and a computed tomography (or magnetic resonance imaging scan [MRI]) if initial imaging was abnormal or physical examination inconclusive.|Two months following completion of treatment with sorafenib according to iwCLL guidelines.|zero participants analyzed due to termination of study|||||
35797|NCT01510756|Primary|Overall Response Rate|Determination of absolute lymphocyte count (ALC), lymphadenopathy, splenomegaly, and/or marrow leukemia as measured by 4-color flow minimal residual disease (MRD) panel after 3 cycles of study treatment. (Decrease in absolute lymphocyte count by 50%, decrease in lymphadenopathy (sum of lymph node product) by 50%, decrease in splenomegaly by 50%, or decrease in leukemia infiltration of the bone marrow by 50%.)|3 months|Zero participants analyzed due to termination of study|||||
35798|NCT01510717|Primary|Mesopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
35799|NCT01510717|Primary|Mesopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
35815|NCT01510457|Primary|Pain Anxiety Symptoms Scale (PASS)|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on an anxiety scale||Standard Deviation|Mean
44705|NCT01391663|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter|CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants||L/hr||Standard Deviation|Mean
35800|NCT01510717|Primary|Photopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
35801|NCT01510717|Secondary|Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses for seeing objects up close?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.||participants|||Number
35802|NCT01510717|Secondary|Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses overall?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.||participants|||Number
35803|NCT01510717|Secondary|Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180|VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.||logMAR|Participants|Standard Error|Mean
35804|NCT01510717|Secondary|Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180|VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.||logMAR|Participants|Standard Error|Mean
35805|NCT01510717|Primary|Photopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.||logMAR||Standard Deviation|Mean
35806|NCT01510717|Primary|Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180|Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.|Day 0 first operative eye visit, up to Day 120-180 from second eye implantation|This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).||adverse events|Participants||Number
35807|NCT01510717|Primary|Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180|Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.||logMAR|Participants|Standard Error|Mean
35808|NCT01510704|Primary|Post-operative Nausea or Vomiting||24 hours|ITT||participants|||Number
35809|NCT01510652|Secondary|Implant Duration|This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.|Total duration of the implant procedure reported at the end of the procedure|The number of participants analyzed is the number of patients with implant data duration time available.||min||Standard Deviation|Mean
35810|NCT01510652|Secondary|Percentage of Cardiac Resynchronization Therapy Responders|Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)|Baseline and 6 months|The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable)||% of patients that are CRT responders|||Number
35811|NCT01510652|Primary|Lead Performance|"Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.~Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off."|6 months|||% of patients with freedom from event|||Number
35817|NCT01510457|Secondary|Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day|Averages of daily diary outcomes were taken over the first and last week of the trial (week 1 and week 11) to compare pre and post treatment. diary was filled out 3 times a day and asked subjects to rate pain at rest, pain when walking, and fatigue on a scale 0-10 (0=none, and 10=the worst)|electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11|||units on a 0-10 NRS scale||Standard Deviation|Mean
35818|NCT01510457|Primary|McGill Pain Questionnaire – Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.|||units on a pain scale||Standard Deviation|Mean
35819|NCT01510379|Secondary|Quantify the Amounts of Phenergan Used Between the Two Groups.||one week|||mg||Standard Deviation|Mean
35820|NCT01510379|Primary|Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.|Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).|24 hours|||units on a scale||Standard Deviation|Mean
35821|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
35822|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
35823|NCT01510327|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
35824|NCT01510327|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
35825|NCT01510327|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
35826|NCT01510327|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
35827|NCT01510327|Secondary|All Death|Number of participants no longer alive|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants who died|||Number
35828|NCT01510327|Secondary|Total Blood Clearance - Everolimus (CL)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; CL could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine CL value.||L/h||Standard Deviation|Mean
35855|NCT01509638|Secondary|Patient Discharged From Hospital for at Least 3 Days|Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants|||Number
35829|NCT01510327|Secondary|Terminal Phase Half-life (t1/2) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; half-life could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine half-life.||Hours||Standard Deviation|Mean
35830|NCT01510327|Secondary|Time of Occurrence of Maximum Everolimus Concentration (Tmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups reported here had 3 or more subjects.||hours||Standard Deviation|Mean
35831|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; AUC0-∞ could be inaccurately determined for a subset of samples. AUC0-∞ determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine AUC0-∞.||ng*hr/mL||Standard Deviation|Mean
35832|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.||ng*hr/mL||Standard Deviation|Mean
35833|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.||ng*hr/mL||Standard Deviation|Mean
35834|NCT01510327|Primary|Maximum Observed Everolimus Blood Concentration (Cmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.||ng/mL||Standard Deviation|Mean
35835|NCT01510158|Secondary|Tophus|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 Months|||Proportion of Subjects|||Number
35836|NCT01510158|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12|12 Months|||Gout Flares||Standard Deviation|Mean
35837|NCT01510158|Primary|Proportion of Subjects With an sUA Level That is < 6.0 mg/dL||6 Months, analysis after all subjects complete 12 months|Intent-to-Treat Population||Proportion of Subjects|||Number
35838|NCT01510145|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|This anaylysis population includes all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.||percentage of patients|||Number
35839|NCT01510145|Primary|Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|This analysis population includes all patients who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.||mmHg||Standard Deviation|Mean
35840|NCT01509807|Secondary|Experienced Any Health Problems or Changed in Health Since Hospital Discharge|Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
35841|NCT01509807|Secondary|Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
35856|NCT01509638|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical analgesia|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants|||Number
35842|NCT01509807|Secondary|Make Unplanned VIsit(s) With Any Healthcare Providers|Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
35843|NCT01509807|Secondary|Readmission to Hospital Since Discharge|Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
35844|NCT01509807|Secondary|Patient Discharged From the Hospital for at Least 3 Days|Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||participants|||Number
35845|NCT01509807|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||percentage of patients|||Number
35846|NCT01509807|Primary|Health Economic Benefit - Length of Stay|Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||days||Full Range|Median
35847|NCT01509807|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||events|||Number
35848|NCT01509807|Primary|Health Economic Benefits - Total Cost of Hospitalization|1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||dollars||Standard Deviation|Mean
35849|NCT01509807|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time the discharge order is written or Day 30, whichever is sooner|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).||mg morphine equivalent||Standard Deviation|Mean
35850|NCT01509664|Primary|Gross Weekly Purchasing of Fruits and Vegetables|Gross weekly purchasing of fruits and vegetables from the discounted items list in $|week|||$||Standard Error|Mean
35851|NCT01509638|Secondary|Time to First Opioid Administration|Time in hours to first opioid administration|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||hours||Full Range|Median
35852|NCT01509638|Secondary|Experienced Health Problems or Changes in Health Since Hospital Discharge|Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants who answered yes|||Number
35853|NCT01509638|Secondary|Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants who answered yes|||Number
35854|NCT01509638|Secondary|Patient Made Unplanned Visit(s) With Any Healthcare Providers|Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||participants who answered yes|||Number
35857|NCT01509638|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||number of events||Standard Deviation|Mean
35858|NCT01509638|Primary|Health Economic Benefit|Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||days||Full Range|Median
35859|NCT01509638|Primary|Health Economic Benefits|Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||dollars||Standard Deviation|Mean
35860|NCT01509638|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)||mg morphine equivalent||Standard Deviation|Mean
35861|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding tumor ki67 expresion in 121 patients.||month||95% Confidence Interval|Median
35862|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2|"To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding HER2 status in 31 patients.||month||95% Confidence Interval|Median
35863|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were 5 patients that have not received previous tamoxifen or an aromatases inhibitor, so they are not included in one of these two groups.||month||95% Confidence Interval|Median
35864|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases|"Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients.||month||95% Confidence Interval|Median
35865|NCT01509625|Secondary|Number of Participants With Adverse Events||22 months|||percentage of patients||95% Confidence Interval|Number
35866|NCT01509625|Secondary|Duration of Clinical Benefit|"Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|For the study of the duration of the clinical benefit, only the patients that get a clinical benefit could be analyzed (this is the reason becasuse the number of participants analyzed was 140)||month||95% Confidence Interval|Median
35867|NCT01509625|Secondary|Overall Survival|Response to treatment with fulvestrant in terms of Overall Survival|22 months|||month||95% Confidence Interval|Median
35868|NCT01509625|Secondary|Clinical Benefit Rate|Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).|22 months|||percentage of patients|||Number
35869|NCT01509625|Primary|Progression Free Survival|"Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|22 months|||month||95% Confidence Interval|Median
35870|NCT01509586|Primary|Quit Attempts and Abstinence|"% of study participants making a quit attempt or staying abstinent from smoking during the study~Notes:~Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence"|From study enrollment through end of one-year follow up|||percentage of participants|||Number
35871|NCT01509105|Secondary|Number of Participants Discontinued Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose of study vaccination (13 Months)|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.||participants|||Number
35872|NCT01509105|Secondary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no-resolved'.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."||participants|||Number
35873|NCT01509105|Secondary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, n signifies those participants who were evaluable at specified time points."||participants|||Number
35874|NCT01509105|Secondary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."||days||Standard Deviation|Mean
35875|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
35876|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
35877|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
35891|NCT01509053|Secondary|Clinical Global Impression of Improvement (CGI-I) Score|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
35878|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
35879|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
35880|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
35881|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.||participants|||Number
35882|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “number of participants analyzed” (N) signifies those participants who were evaluable for this outcome measure.||participants|||Number
35883|NCT01509079|Secondary|Vitamin D Binding Protein Genotype||Baseline||||||
35884|NCT01509079|Secondary|Bone Mineral Density||Change from screen to 6 months||||||
35885|NCT01509079|Secondary|Change in Steady State Concentrations of Serum Anastrazole and Letrozole|Difference in steady state concentrations in plasma from baseline to 6 months|baseline to 6 months|Only study participants with baseline and 6 month blood samples available were analyzed||mg/L||Standard Deviation|Mean
35886|NCT01509079|Secondary|Serum Estradiol Concentrations||baseline and 6 months|only participants whose serum was obtained at both time points are included||pg/ml||Standard Error|Geometric Mean
35887|NCT01509079|Secondary|Average Percent Adherence to Vitamin D Interventio|adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months|average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months|||% of adherence for each treatment arm|||Number
35888|NCT01509079|Secondary|Change in PROMIS Physical Functioning Questionnaire|PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).|baseline to 6 months|only data from participants with measures at both time points are included||units on a scale||Standard Deviation|Mean
35889|NCT01509079|Primary|Change in Hand Grip Strength||baseline to 6 months|only data from participants that were collected at both time points is included||pounds||Standard Deviation|Mean
35890|NCT01509079|Primary|Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale|The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia|baseline to 6 months|Only participants who provided data at both time points are included||units on a scale||Standard Deviation|Mean
35892|NCT01509053|Secondary|Clinical Global Impression of Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
35893|NCT01509053|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores|The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
35894|NCT01509053|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.|||||
35895|NCT01509053|Primary|Comparison of Inpatient Psychiatric Hospitalization Rates|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.|Retrospective period Months 4-6; Prospective period Months 4-6|Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated.|||||
35896|NCT01509040|Secondary|Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses|Clinical diagnoses of cerebral bleeding, stroke, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, rib or sternal fractures, internal thoracic or abdominal injuries as noted in the discharge summary|Discharge|||participants|||Number
35897|NCT01509040|Secondary|Unexpected Adverse Device Events (UADE)|These will be defined as any unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in this investigation plan or application which will be submitted to the Food and Drug Administration (including a supplementary plan or application), or any other unexpected serious problem associated with a device. The death or neurological impairment of an individual patient will not be considered an adverse event in this study.|48 hours|||participants|||Number
35898|NCT01509040|Secondary|Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia|"ST-Elevation Myocardial Infarction- ECG criteria and biomarker criteria for acute infarction.~Radiographic Pulmonary Edema- radiographic presence of alveolar or interstitial edema, bilateral pleural effusions, cardiomegaly or venous congestion.~Arrhythmia- other than sinus rhythm observed after randomization. Arrhythmia requiring treatment- rhythm with subsequent use of an antiarrhythmic drug or electrical therapy observed after randomization.~Arrhythmia with cardiovascular instability- any rhythm with cardiovascular instability as determined by the DSMB, observed after randomization."|48 hours|||Participant|||Number
35899|NCT01509040|Secondary|Expected Adverse Event|"Device-Related Hematoma at insertion site, vessel perforation, wound infection, deep venous thrombosis or pulmonary embolism.~Device Failure Mechanical failure Hypertension- SBP>160 mmHg, or DBP >120 mmHg. Hypotension- SBP<60 mmHg. Hypervolemia- CVP > 12 cm. Hypovolemia- CVP < 2 cm. Hypokalemia- serum potassium concentration < 3.5 mmol/L. Alkalosis- serum bicarbonate > 32 mmol/L. Hyperglycemia- serum glucose > 240 mg/dL. Hypophosphatemia- serum phosphate concentration < 0.8 mmol/L. Hypocalcemia- serum ionized calcium < 2.2 mmol/L. Lactic acidosis- serum lactate > 6 mmol/L."|48 hours|||participants|||Number
35900|NCT01509040|Secondary|Time Interval From 911 Call to Patient Death|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|1 year|||Days||Inter-Quartile Range|Mean
35901|NCT01509040|Secondary|Number of Hospital Days|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|6 months|||days||Inter-Quartile Range|Mean
35902|NCT01509040|Secondary|Ejection Fraction|This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients|48 hours|||percentage||Inter-Quartile Range|Mean
35903|NCT01509040|Secondary|Shock|This will be defined as systolic blood pressure < 65 at the end of any four hour period during the initial 48 hours of enrollment in control and intervention patients.|48 hours|||participants|||Number
35904|NCT01509040|Secondary|Use of Pressors and Inotropes|This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.|48 hours|||participants|||Number
35905|NCT01509040|Secondary|Total Volume Intravenous Fluid Infused|This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.|48 hours|||mL||Inter-Quartile Range|Mean
35906|NCT01509040|Secondary|Clearance of Inflammatory Mediators|Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.|48 hours|The outcome was not assessed.|||||
35907|NCT01509040|Secondary|Enrollment|This will be defined as the proportion of eligible patients who are randomized.|12 hours|||participants|||Number
35908|NCT01509040|Primary|Intervention Compliance|Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.|48 hours|||participants|||Number
35909|NCT01508936|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion at screening, weeks 8 and 16 or early withdrawal. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).~Endpoint =week 16 or early withdrawal.~Counts represent the total number of participants at each time point with a positive immunogenicity test, and not 'new' participants with a positive test. An overall status of positive includes participants who had a positive ADA at any time point."|Screening (Week -3), Weeks 8 and 16|Safety analysis set; antibody assessments reported for active treatment arm only.||participants|||Number
35910|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities|Counts represent the number of participants with potentially clinically significant ECG abnormalities as assessed by the investigator.|Week 16 or endpoint|Safety analysis set||participants|||Number
35911|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values during any of the treatment period exams.~Significance criteria~Heart rate - high: >100 and increase of >= 30 beats/minute (bpm)~Sitting systolic blood pressure - high: >160 and increase of >=30 mmHg~Sitting systolic blood pressure - low: <90 and decrease of >=30 mmHg~Sitting diastolic blood pressure - high: >100 and increase of >=12 mmHg~Sitting diastolic blood pressure - low: <50 and decrease of >=12 mmHg~Body temperature - high: >100.5° Fahrenheit or 38.1° Celsius and increase of >2°~Body temperature - low: <96.5° Fahrenheit or <35.8° Celsius"|Week 4 to Week 28|Safety analysis set of participants with assessments||participants|||Number
35912|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values during any of the lab tests conducted during the treatment period.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 4-49 U/L.~Total bilirubin: >=34.2 μmol/L~Creatinine phosphokinase: >5*ULN. Normal range is 24-207 U/L.~White blood cells: <=3.0 or >20 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Platelets: <=75 10^9/L~Absolute neutrophil count: <=1.0 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 16|Safety analysis set with assessments||participants|||Number
35913|NCT01508936|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 28|The safety analysis set includes all patients who took at least 1 dose of study drug, regardless of whether the patients were randomized.||participants|||Number
35914|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16|The ACQ score was measured using the ACQ-7. Six questions are self-assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12 and 16|Full analysis set. Number of participants analyzed represents # with ACQ baseline values. Number participants with assessments in the timeframes are listed with the time designation. ACQ were excluded if obtained at visits which were preceded by usage within 7 days of a limited subset of medications that could significantly alter interpretation.||units on a scale||Standard Error|Least Squares Mean
35915|NCT01508936|Secondary|Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint|Blood eosinophil counts were measured using a standard complete blood count with differential blood test at each scheduled visit. Follow-up was performed approximately 12 weeks after the 16 week treatment period. Endpoint is the last post-baseline assessment.|Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)|Full analysis set. Number of participants analyzed represents # with blood eosinophil count baseline values. Number participants with assessments in the timeframes are listed with the time designation.||10^9/liter||Standard Deviation|Mean
35916|NCT01508936|Secondary|Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16|SABA are used for quick relief of asthma symptoms. The number of times SABA therapy was used was assessed using 3 day recall at scheduled visits. Participants were asked to recall whether SABAs were used within 3 days of the scheduled visit and, if so, how many puffs were used. Daily use was the average of those 3 days. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with SABA use baseline values. Number participants with assessments in the timeframes are listed with the time designation.||puffs of SABA/day||Standard Error|Least Squares Mean
35917|NCT01508936|Secondary|Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16|The FEF25%-75% is the forced expiratory flow at 25% to 75% of the forced vital capacity. FEF25%-75% was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEF25%-75% baseline values. Number of participants with assessments in the timeframes are listed with the time designation.||liters/second||Standard Error|Least Squares Mean
35918|NCT01508936|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. FV was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FVC baseline values (one reslizumab participant was missing a valid baseline FVC.) Number participants with assessments in the timeframes are listed with the time designation.||liters||Standard Error|Least Squares Mean
35919|NCT01508936|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient’s predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.||percentage of predicted FEV1||Standard Deviation|Mean
35920|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16|FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.||liters||Standard Error|Least Squares Mean
35921|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.~As with the primary outcome, data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group. However the FEV1 subpopulation includes participants with more impaired lung function (% predicted FEV1 <85% at baseline)."|Baseline (Day 1), Week 16|The FEV1 sub-population analysis set includes all participants in the FAS with % predicted FEV1 <85% at baseline. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
35922|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient’s % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.~During study (Weeks 4, 8, 12 and 16) average value was calculated from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, history of asthma exacerbation in the previous year, height, baseline value, and sex as fixed factors, and patient as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set of participants who contributed at least once to the analysis. ACQ were excluded from the FAS if they were obtained at scheduled visits which were preceded by usage within 7 days of a limited subset of medications that could significantly confound interpretation.||units on a scale||Standard Error|Least Squares Mean
35923|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.~During study (Weeks 4, 8, 12 and 16) average value was calculated using a mixed effects model for repeated measures (MMRM) with treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and contributed at least once to the analysis. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.||liters||Standard Error|Least Squares Mean
35924|NCT01508936|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.~Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group."|Baseline (Day 1), Week 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and had assessments in the timeframes. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
35925|NCT01508910|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period||From randomization until the end of the 24 month follow-up period|Safety Population as Treated.||percent|||Number
35981|NCT01508013|Primary|Indoor Tanning Behavior|Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the future.||Indoor tanning sessions over past year||Standard Deviation|Mean
35926|NCT01508910|Secondary|Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period|"Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee.~The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke."|From randomization until the end of the 24 month follow-up period|Participants in the safety population as Treated.||percent||95% Confidence Interval|Number
35927|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit||6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||angina episodes per week||Standard Deviation|Mean
35928|NCT01508910|Secondary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||seconds||Standard Deviation|Mean
35929|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit|Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||angina episodes per week||Standard Deviation|Mean
35930|NCT01508910|Primary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.||seconds||Standard Deviation|Mean
35931|NCT01508832|Primary|The Change in the Average Finger Temperature From Baseline to Post-intervention.||30 minutes prior and 240 minutes post intervention.|The correspondingly-treated(lidocaine, bupivacaine) finger of all 12 study participants included in analysis for each arm/group||degrees centigrade||Standard Error|Mean
35932|NCT01508702|Primary|Number of Subjects With an sUA Level That is < 6.0 mg/dL||6 months|ITT Population||Number of Subjects|Participants||Number
35933|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment|"Subjects rated their constant pain and hypersensitivity using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks|||Visual Analog Scale||Standard Deviation|Mean
35934|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Burning After Treatment|"Subjects rated their burning pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks|Only subjects||Visual Analog Scale||Standard Deviation|Mean
35935|NCT01508676|Primary|VAS After Treatment|"Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks.|Only subjects who completed both phases of the crossover study were considered for data analysis.||Visual Analog Scale||Standard Deviation|Mean
35936|NCT01508455|Secondary|Time to Successful Extubation||From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours)|Subjects who had successful extubation alone (n=5) were included in this analysis.||Hours||95% Confidence Interval|Median
35937|NCT01508455|Secondary|Time Spent With a Total N-PASS Score >3 During DEX Infusion|The N-PASS score >3 indicates adequately sedated and not manifesting signs of pain/agitation.|Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.||Hours||Standard Deviation|Mean
35938|NCT01508455|Secondary|Amount of Rescue Medication for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|Number of subject who received rescue medication for analgesia during DEX infusion||mcg/kg|||Number
35939|NCT01508455|Secondary|Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|No participants analyzed for this assessment since none required rescue Midazolam for sedation.|||||
35940|NCT01508455|Secondary|Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.||participant|||Number
35941|NCT01508455|Primary|Percent of Subjects Requiring Rescue Midazolam for Sedation||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All Subjects who received study drug for at least 6 hours||percentage of participants|||Number
35942|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 24 hours heart rate at Week 12 and of the baseline heart rate was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
35943|NCT01508325|Secondary|Heart Rate Response Rate|Heart rate response was defined as decrease in heart rate from baseline >=10 percent (%). Heart rate response rate was calculated by using the number of subjects with heart rate response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.||percentage of subjects|||Number
35944|NCT01508325|Secondary|Blood Pressure Response Rate|Blood pressure response was defined as DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.||percentage of subjects|||Number
35945|NCT01508325|Secondary|Change From Baseline in 24-hour Blood Pressure Variability at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
35946|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
35947|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
35948|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12|The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
35949|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
35950|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
35951|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||mmHg||Standard Deviation|Mean
37411|NCT01486966|Secondary|Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment|FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L.|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
35952|NCT01508325|Primary|Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.||beats/min||Standard Deviation|Mean
35953|NCT01508325|Primary|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment|Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all the randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively||mmHg||Standard Deviation|Mean
35954|NCT01508169|Secondary|Manchester Foot and Pain Disability Index(MFPDI)|"The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase Because of pain in my feet…, organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: none of the time (score = 0), some days (score = 1), and most days/every day (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability."|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||scores on a scale||Standard Deviation|Mean
35955|NCT01508169|Secondary|Numeric Pain Scale|Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||units on a scale||Standard Deviation|Mean
35956|NCT01508169|Primary|Timed up and Go Test (TUG)|The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||seconds||Standard Deviation|Mean
35957|NCT01508169|Primary|Berg Balance Scale (BBS)|The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.||scores on a scale||Standard Deviation|Mean
35958|NCT01508130|Secondary|Change From Baseline in Work Loss And Productivity Outcomes (WPAI)|WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.|Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||units on a scale||Standard Error|Least Squares Mean
35959|NCT01508130|Secondary|Number of Participants With Any AEs and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. All 671 participants received at least one dose of study drug; however, 632 of these participants were included in the safety population.||participants|||Number
35960|NCT01508130|Secondary|Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.||participants|||Number
37412|NCT01486966|Secondary|Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
35962|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label|As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.|Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)|The safety population was defined as all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35963|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label|As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.|Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35964|NCT01508130|Secondary|Compliance of Study Treatment|Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.|Weeks 4, 8, 12, and 24|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35965|NCT01508130|Secondary|Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||Percentage of dose reduction||Standard Deviation|Mean
35966|NCT01508130|Secondary|Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||Micrograms||Standard Deviation|Mean
35967|NCT01508130|Secondary|Treatment Duration, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.||Weeks||Standard Error|Mean
35968|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Intolerance|The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||Weeks||Full Range|Median
35969|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Lack of Efficacy|The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||Weeks||Full Range|Median
35970|NCT01508130|Secondary|Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment|The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant’s first date of undetectable HCV RNA and the date of the participant’s last dose.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||weeks||Full Range|Median
35980|NCT01508013|Primary|Indoor Tanning Intentions|A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the next year.||units on a scale||Standard Deviation|Mean
35971|NCT01508130|Secondary|Number of Participants With SVR by Subgroups (Demographic and Baseline Factors)|Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease < 2 log10 at Week 12), partial responder (HCV RNA decrease > 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant’s choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.|Week 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35972|NCT01508130|Secondary|Predictors of Sustained Virologic Response by Week|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA < 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA < 50 IU/mL or unquantifiable or HCV-RNA >=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.|Weeks 2, 4, 6, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35973|NCT01508130|Secondary|Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder|The extended VR is defined as initial HCV RNA < 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA < 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by >=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA < 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35974|NCT01508130|Secondary|Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above|VRVR was defined as HCV RNA < 50 IU/mL at treatment Week 2; RVR as HCV RNA < 50 IU/mL by treatment Week 4, but no HCV RNA < 50 IU/mL at Week 2; Week 8 VR as HCV RNA < 50 IU/mL by study Week 8 but no HCV RNA < 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA < 50 IU/mL by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 12.|Weeks 2, 4, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35975|NCT01508130|Secondary|Number of Participants With Virologic Response (VR)|VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)|Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.||participants|||Number
35976|NCT01508130|Primary|Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period|12 weeks or later post-completion of the treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.||participants|||Number
35977|NCT01508130|Primary|Time to Premature Treatment Discontinuation Due to Any Reason|Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason – first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.|Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)|modified all-treated (mTRT) population: It included all enrolled participants who had an hepatitis C Virus Ribo Nucleic Acid (HCV RNA) of 50 IU/mL or more just prior to start chronic hepatitis C (CHC) therapy, received 1 triple therapy (PegIFN, RBV, and TEL or BOC), and treatment documentation was sufficient for assignment to treatment groups.||weeks||95% Confidence Interval|Median
35978|NCT01508052|Primary|Core Body Temperature|Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.|from baseline record core temperature every 15 minutes up to operative end|||degree C||Standard Deviation|Mean
36790|NCT01495858|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent.|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
35982|NCT01507896|Primary|Incremental Recovery (IR) at 15±5 Minutes Following Loading Dose Prior to Surgery|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 15±5 minutes for the loading dose.|Within 60 minutes prior to surgery and 15 ± 5 minutes after loading dose/rebolus, if applicable.|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who provided data for incremental recovery (IR) after the loading dose prior to surgery.~Note: a unique participant could have more than one surgical procedure."||[IU/dL] : [IU/kg]|surgeries with IR data|Standard Deviation|Mean
35983|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Vss was computed as CL·MRT.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||dL/kg|pre-surgical PK assessments|Standard Deviation|Mean
35984|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|T1/2 was determined as ln2 / λz.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
35985|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Incremental Recovery (IR) at 30 Min|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 30±5 minutes for pre-surgical PK.|Within 30 mins pre-infusion and post-infusion at 30 minutes|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||IU/dL : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
35986|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|CL is the volume of plasma which is completely cleared of study product per unit time and is calculated as the dose divided by the total area under the curve from 0 to infinity (AUC0-inf).|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||dL/(kg•hr)|pre-surgical PK assessments|Standard Deviation|Mean
35987|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Mean Residence Time (MRT)|The MRT is the average time that the study product stays in the body (or plasma) and is calculated as: AUMC 0-inf / AUC 0-inf, where AUMC 0-inf was determined in a similar manner as AUC 0-inf.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
35988|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve Per Dose (Total AUC/Dose)|Total AUC/Dose is also AUC0-inf (area under the plasma concentration/time curve from time 0 to infinity) and was defined as AUC0-t + Ct / λz, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration and λz is the terminal rate constant.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
35989|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 72 Hours Post-infusion Per Dose|AUC0-72h (area under the plasma concentration/time curve from time 0 to 72 hours) was computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R2.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
35990|NCT01507896|Primary|Safety: Occurence of a Thrombotic Event||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||surgeries|treatments with BAX326 before surgery||Number
35991|NCT01507896|Primary|Safety: Number of Adverse Events Related to BAX326||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||adverse events|treatments with BAX326 before surgery||Number
35992|NCT01507896|Primary|Safety: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|If there was more than 2-dilution increase as compared to pre-study level at screening.|Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||participants|treatments with BAX326 before surgery||Number
35993|NCT01507896|Primary|Safety: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."||participants|treatments with BAX326 before surgery||Number
35994|NCT01507896|Primary|Volume of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.~Note: a unique participant could have more than one surgical procedure."||mL|surgery where blood transfusion given|Standard Deviation|Mean
35995|NCT01507896|Primary|Number of Units of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.~Note: a unique participant could have more than one surgical procedure."||units|surgery where blood transfusion given|Standard Deviation|Mean
35996|NCT01507896|Primary|Total Weight-Adjusted Dose of BAX326 Per Participant|Assessed for the intra- and postoperative periods.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."||IU/kg|surgeries|Standard Deviation|Mean
35997|NCT01507896|Primary|Daily Weight-Adjusted Dose of BAX326 Per Participant|"Daily weight-adjusted doses of BAX326 per participant were recorded from the day of surgery until postoperative Days 11+.~Each category in outcome measure includes number of all, major and minor surgeries, respectively, if different from the totals."|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."||IU/kg|surgeries|Standard Deviation|Mean
35998|NCT01507896|Primary|Actual Postoperative Blood Loss Compared to Average and Maximum Blood Loss Predicated Preoperatively by the Operating Surgeon|"Predicted average/maximum blood loss minus actual blood loss for participants who had a drain placed during surgery.~Prior to the surgery, the surgeon will predict the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study subject for the postoperative period until drain removal."|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure."||mL|surgeries with drain placed|Standard Deviation|Mean
35999|NCT01507896|Primary|Actual Postoperative Blood Loss|Postoperative blood loss was based on the drainage fluid and was only assessed for participants who had a drain placed during surgery.|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure."||mL|surgeries with drain placed|Standard Deviation|Mean
36000|NCT01507896|Primary|Postoperative Hemostatic Efficacy on Day of Discharge|"Assessment by the operating surgeon on a 4 point ordinal scale:~Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant~Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant~Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."||surgeries|surgeries||Number
36001|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Postoperative Day 3|"Assessment by the operating surgeon on a 4 point ordinal scale:~Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant~Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant~Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set who were provided with a hemostatic efficacy assessment by the operating surgeon at post operative day 3 where no drain was employed.~Note: a unique participant could have more than one surgical procedure."||surgeries|surgeries||Number
36015|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
36002|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Drain Removal|"The postoperative hemostatic efficacy was to be assessed by the operating surgeon according to the following criteria (4-point ordinal scale):~Excellent: Volume in drain was less than or equal than that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )~Good: Volume in drain was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101% - 150%)~Fair: Volume in drain was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)~None: Uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure"||major surgeries with drain placed|major surgeries with drain placed||Number
36003|NCT01507896|Primary|Actual Intraoperative Blood Loss Compared to Average and Maximum Blood Loss Predicted Preoperatively by the Operating Surgeon|Predicted average/maximum blood loss minus actual blood loss. Prior to the surgery, the surgeon predicted the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study participant for the intraoperative period.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."||mL|surgeries|Standard Deviation|Mean
36004|NCT01507896|Primary|Actual Intraoperative Blood Loss|Actual intraoperative blood loss was determined by the drainage volume, if a drain was placed, and the estimated blood loss into swabs and towels during the procedure.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."||mL|surgeries|Standard Deviation|Mean
36005|NCT01507896|Primary|Intraoperative Hemostatic Efficacy|"Assessment by the operating surgeon on a 4 point ordinal scale (according to the definitions provided below):~Excellent: Intraoperative blood loss was less than or equal to that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )~Good: Intraoperative blood loss was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101 – 150%)~Fair: Intraoperative blood loss was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)~None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 and had surgery.~Note: a unique participant could have more than one surgical procedure."||surgeries|surgeries||Number
36006|NCT01507831|Post-Hoc|Percentage of Participants Who Experienced Major Adverse CV Events|Major adverse CV events were defined as all adverse CV events except Congestive heart failure (CHF) requiring hospitalization; and ischemia-driven coronary revascularization procedure.|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.||percentage of participants|||Number
36007|NCT01507831|Other Pre-specified|Percentage of Participants Who Experienced Cardiovascular (CV) Events|CV events included coronary heart disease (CHD) death; non-fatal myocardial infarction (MI); fatal and non-fatal ischemic stroke; unstable angina requiring hospitalization; congestive heart failure (CHF) requiring hospitalization; ischemia-driven coronary revascularization procedure. Reported events are CV events as confirmed by an independent Clinical Events Committee (CEC) that occurred during the treatment emergent period ( i.e. from first dose up to the last dose of study drug + 70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.||percentage of participants|||Number
36008|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.||percent change||Standard Error|Least Squares Mean
36009|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.||percent change||Standard Error|Least Squares Mean
36010|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
36011|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
36012|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A1 ITT population.||percent change||Standard Error|Least Squares Mean
36013|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
36014|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
36016|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).||percent change||Standard Error|Least Squares Mean
36017|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
36018|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
36019|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Mean
36020|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.||percentage of participants|||Number
36021|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
36022|NCT01507831|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.||percentage of participants|||Number
36023|NCT01507831|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in imputation model.|Up to Week 52|ITT population.||percentage of participants|||Number
36024|NCT01507831|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.||percent change||Standard Error|Least Squares Mean
36025|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.||percent change||Standard Error|Least Squares Mean
36026|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.||percent change||Standard Error|Least Squares Mean
36027|NCT01507831|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).||percent change||Standard Error|Least Squares Mean
36028|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).||percent change||Standard Error|Least Squares Mean
36029|NCT01507831|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).||percent change||Standard Error|Least Squares Mean
36075|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.||unitless||95% Confidence Interval|Number
36030|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).||percent change||Standard Error|Least Squares Mean
36031|NCT01507831|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).||percent change||Standard Error|Least Squares Mean
36032|NCT01507831|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment.||percent change||Standard Error|Least Squares Mean
36033|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.||percent change||Standard Error|Least Squares Mean
36034|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.||percent change||Standard Error|Least Squares Mean
36035|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
36036|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.||percent change||Standard Error|Least Squares Mean
36037|NCT01507831|Primary|Percentage of Participants Who Experienced Adverse Events (AEs)|Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).||percentage of participants|||Number
36038|NCT01507493|Secondary|Preoperative Pressure Pain Tolerance (PTO)|The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say “ok” when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.|12 hours before the operation|||kg/cm2||Standard Deviation|Mean
36039|NCT01507493|Primary|PCA Press Frequency 48h After Operation.||48 hours after the operation|||presses per day||Standard Deviation|Mean
36040|NCT01507493|Secondary|Preoperative Pressure Pain Threshold (PPT)|The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say “pain” when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.|12 hours before the operation|||kg/cm2||Standard Deviation|Mean
36041|NCT01507493|Secondary|The Visual Analog Scale 48h After Operation.|The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain|48 hours after the operation|||units on a scale||Standard Deviation|Mean
36042|NCT01507493|Primary|Opioid Consumption Dose 48h After Operation.||48 hours after the operation|||microgramme||Standard Deviation|Mean
36043|NCT01507246|Primary|Health Economic Benefits - Length of Stay|Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Up to Day 30|All subjects analyzed, no censored events||days||Inter-Quartile Range|Median
36044|NCT01507246|Secondary|Incidence of Predefined Opioid-related Adverse Events|The incidence of predefined opioid-related adverse events|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner|Per protocol.||Number of patients|||Number
36045|NCT01507246|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|per protocol||dollars||Standard Deviation|Mean
36046|NCT01507246|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|Per protocol||mg||Standard Deviation|Mean
36076|NCT01507090|Primary|Predictive Performance of the Mercy TAPE|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||root mean square error (kg)|||Number
36047|NCT01507233|Secondary|Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia.|"Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.~Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
36048|NCT01507233|Primary|Health Economic Benefits|"Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.~Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to Day 30|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
36049|NCT01507233|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
36050|NCT01507220|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
36051|NCT01507220|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||Adverse events|||Number
36052|NCT01507220|Primary|Health Economic Benefit|"Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner.~Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
36053|NCT01507220|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||||
36054|NCT01507181|Secondary|Patient Rated Inventory of Side Effects (PRISE)|The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Data reported in in Adverse Events section.|duration of study|||events|||Number
36055|NCT01507181|Secondary|The Clinician-Administered Dissociative States Scale (CADSS)|The CADSS measures dissociation with higher scores indicating more severe symptoms (scale range 0 – 92).|baseline, 40 minutes post infusion and 240 minutes post infusion|||units on a scale||Standard Deviation|Mean
36056|NCT01507181|Secondary|The Brief Psychiatric Rating Scale (BPRS)|The BPRS measures psychomimetic effects with higher scores indicating more severe symptoms (scale range 7 – 49).|baseline, 40 minutes post infusion, and 240 minutes post infusion|||units on a scale||Standard Deviation|Mean
36057|NCT01507181|Secondary|The Young Mania Rating Scale (YMRS)|An 11-item questionnaire, used to assess manic symptoms based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.|baseline, 40 minutes post infusion, 240 minutes post infusion|||units on a scale||Standard Deviation|Mean
36058|NCT01507181|Secondary|Suicidality Item of the MADRS (MADRS-SI)|The MADRS-SI ranges from 0 to 6; a score of 2 corresponds to fleeting, passive SI; a score of 4 indicates that SI is frequent with at least moderate intensity but without specific plans or intention; a score of 6 corresponds to active intention and planning for suicide.|24 hours post infusion|||units on a scale||Standard Deviation|Mean
36059|NCT01507181|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|up to 7 days post infusion|||units on a scale||Standard Deviation|Mean
36060|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 48 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 48 hours post infusion|||units on a scale||Standard Deviation|Mean
36061|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 24 hours post infusion|||units on a scale||Standard Deviation|Mean
36074|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.||unitless||95% Confidence Interval|Number
36817|NCT01495572|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|10 months|||participants|||Number
36062|NCT01507155|Secondary|Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months|"To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales:~Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression~Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life~Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating~the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe"|3 months|Only 197 patients completed self-assessments at 3 months.||Scores on a scale||Standard Deviation|Mean
36063|NCT01507155|Primary|Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months|To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).|3 months|||Participants|||Number
36064|NCT01507103|Primary|Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline|IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available|||||
36065|NCT01507103|Secondary|Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)|Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.|Baseline and Week 18 (follow-up / end-of trial)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analysed for each category.||log2 (percentage of T cells)||Standard Deviation|Mean
36066|NCT01507103|Secondary|Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)|Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).|Baseline and Week 14 (post-surgery)|The pre-specified statistical threshold for reporting of results of planned analysis for either arm or interaction effect was not met in the analysis population. Hence the data was not assessed for the outcome measure.|||||
36067|NCT01507103|Primary|Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline|IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available|||||
36068|NCT01507103|Primary|Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category|A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).|18 weeks|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive.||subjects|||Number
36069|NCT01507103|Primary|Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)|Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.|Baseline and Week 14 (post-surgery)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analyzed for each category.||TILs per 100 tumor cells||Standard Deviation|Mean
36070|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||root mean square error (kg)|||Number
36071|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||correlation coefficieint|||Number
36072|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Percentage Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.||percentage error||Standard Deviation|Mean
36073|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.|study day 1|Final population for data analysis.||percent of estimations||95% Confidence Interval|Number
36077|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||correlation coefficient|||Number
36079|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Percent of Participants)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg). The outcome measure below relfects the percent of participants with weight estimated within within 20% of actual weight.|study day 1|||percent of participants||95% Confidence Interval|Number
36080|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Slope)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|||unitless||95% Confidence Interval|Number
36081|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Intercept)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|||kilograms||95% Confidence Interval|Number
36082|NCT01507090|Secondary|Device Print Batch Variability|"Geometric mean of the ratio (CV) of true to estimated weight calculated by TAPE version. Mercy TAPEs were printed in 2 batches numbers 1 and 2 accordingly."|study day 1|||ratio||Geometric Coefficient of Variation|Geometric Mean
36083|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Percentage Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||percentage error||Standard Deviation|Mean
36084|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis||kilograms||Standard Deviation|Mean
36085|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Intercept)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.||kilograms||95% Confidence Interval|Number
36086|NCT01507090|Secondary|Inter-rater Reliability for the 2D and 3D Mercy TAPEs.|Intraclass correlation coefficient|study day 1|All pre-qualified study coordinators||Intraclass correlation coefficient|||Number
36087|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Slope)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.||unitless||95% Confidence Interval|Number
36088|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.|study day 1|Final population for data analysis.||percentage of participants||95% Confidence Interval|Number
36089|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||1/Liter||Geometric Coefficient of Variation|Geometric Mean
36090|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
36091|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||1/Liter||Geometric Coefficient of Variation|Geometric Mean
36092|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
36093|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of Rivaroxaban After Last Dose|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|3, 24, 48, and 72 h after the last administration of rivaroxaban|PK/PD set; derived parameter could not be evaluated for all participants.||hours||Geometric Coefficient of Variation|Geometric Mean
36094|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Minimum (Trough) Concentration (Ctrough) of Rivaroxaban After Second to Fourth Dose|Ctrough refers to the time after dosing when the drug concentration is expected to reach its minimum (trough) concentration.|Always 24 h after the second, third, and fourth dose|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
36095|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Maximum (Peak) Concentration (Cpeak) of Rivaroxaban After Second to Fourth Dose|Cpeak refers to the time after dosing when the drug concentration is expected to reach its maximum (peak) concentration.|Always 3 h after second, third, and fourth dose|PK/PD set||Microg/L||Geometric Coefficient of Variation|Geometric Mean
36096|NCT01507051|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Rivaroxaban After First Dose|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||hours||Full Range|Median
36097|NCT01507051|Secondary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||Kg/L||Geometric Coefficient of Variation|Geometric Mean
36098|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Divided by Dose Per kg Body Weight [AUC(0-24)Norm] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC(0-24)norm] is defined as AUC divided by dose per kg body weight from zero to 24 hours after first (single) dose.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||Kg*h/L||Geometric Coefficient of Variation|Geometric Mean
36099|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of S-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set||hours||Geometric Coefficient of Variation|Geometric Mean
36100|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of R-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set||hours||Geometric Coefficient of Variation|Geometric Mean
36101|NCT01507051|Secondary|Maximum Drug Concentration in Plasma (Cmax) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||microg/L||Geometric Coefficient of Variation|Geometric Mean
36102|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample ([AUC(0-24)] is defined as area under the concentration vs. time curve from zero to 24 hours after first (single) dose).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set||microg*h/L||Geometric Coefficient of Variation|Geometric Mean
36103|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor IIa activity was the area under the measurement (Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at baseline divided by Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36104|NCT01507051|Secondary|Emax (Maximum Effect) on Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. Emax on Factor IIa activity was measured as the ratio of Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma) at baseline divided by minimum Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36105|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor VIIa activity was the area under the measurement (Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at baseline divided by Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36106|NCT01507051|Secondary|Emax (Maximum Effect) on Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. Emax on Factor VIIa activity was measured as the ratio of Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma) at baseline divided by minimum Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36107|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak time was the area under the measurement (ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at different time-points divided by ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36108|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak time was measured as the ratio of maximum ETP peak time (measured in minutes as time to reach the maximum coagulation activity) divided by ETP peak time (measured in minutes as time to reach the maximum coagulation activity) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36290|NCT01502033|Primary|Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.|5 days of Treatment 30 or Last Treatment|||units on a scale||Standard Deviation|Mean
36109|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak was the area under the measurement (ETP peak [measured in nm as maximum coagulation activity] at baseline divided by ETP peak measured [in nm as maximum coagulation activity] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36110|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak was measured as the ratio of ETP peak (measured in nm as maximum coagulation activity) at baseline divided by minimum ETP peak (measured in nm as maximum coagulation activity).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36111|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP lag time was the area under the measurement (ETP lag time [in minutes as measure for the start of coagulation] at different time-points divided by ETP lag time [in minutes as measure for the start of coagulation] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36112|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP lag time was measured as the ratio of maximum ETP lag time (in minutes as measure for the start of coagulation) divided by ETP lag time (in minutes as measure for the start of coagulation) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36113|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP AUC was the area under the measurement (ETP AUC [measured in nm*min as integral of fluorescence measurements] at baseline divided by ETP AUC [measured in nm*min as integral of fluorescence measurements] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36114|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP AUC was measured as the ratio of ETP AUC (measured in nm*min as integral of fluorescence measurements) at baseline divided by minimum ETP AUC (measured in nm*min as integral of fluorescence measurements).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36115|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PiCT was the area under the measurement (PiCT [measured in seconds] at different time-points divided by PiCT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36116|NCT01507051|Secondary|Emax (Maximum Effect) on PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on PiCT was measured as the ratio of maximum PiCT (measured in seconds) divided by PiCT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio||Geometric Coefficient of Variation|Geometric Mean
36117|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of HepTest was the area under the measurement (HepTest [measured in seconds] at different time-points divided by HepTest [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36118|NCT01507051|Secondary|Emax (Maximum Effect) on HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on HepTest was measured as the ratio of maximum HepTest (measured in seconds) divided by HepTest (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio||Geometric Coefficient of Variation|Geometric Mean
36291|NCT01500434|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death|In hospital (average of 1-2 days post index procedure)|Analysis was intention to treat||percentage of participants|||Number
36119|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of aPTT was the area under the measurement (aPTT [measured in seconds] at different time-points divided by aPTT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36120|NCT01507051|Secondary|Emax (Maximum Effect) on aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. Emax on aPTT was measured as the ratio of maximum aPTT (measured in seconds) divided by aPTT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36121|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. AUC(0-tn) of anti-Factor Xa activity was the area under the measurement (anti-Factor Xa activity [measured in U/L] at different time-points divided by anti-Factor Xa activity [measured in U/L] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36122|NCT01507051|Secondary|Emax (Maximum Effect) on Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. Emax on anti-Factor Xa activity was measured as the ratio of maximum anti-Factor Xa activity (measured in U/L) divided by anti-Factor Xa activity (measured in U/L) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.||ratio||Geometric Coefficient of Variation|Geometric Mean
36123|NCT01507051|Secondary|AUC(0-tn) (Area Under the Inverse Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. AUC(0-tn) of Factor Xa activity was the area under the inverse measurement [100*(Factor Xa activity at baseline (measured as activity per mL) - Factor Xa activity (measured as activity per mL) at different time-points) / Factor Xa activity at baseline (measured as activity per mL)] versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||Percentage of inhibition*h||Geometric Coefficient of Variation|Geometric Mean
36124|NCT01507051|Secondary|Emax on Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. Emax on Factor Xa activity was calculated as 100*(Factor Xa activity at baseline [measured as activity per mL] - minimum of Factor Xa activity [measured as activity per mL]) / Factor Xa activity at baseline [measured as activity per mL].|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||Percentage of inhibition||Geometric Coefficient of Variation|Geometric Mean
36125|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) for PT (Measured as INR=International Normalized Ratio)|Prothrombin time – INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT (INR) was the area under the measurement (PT measured as INR at different time-points divided by PT measured as INR at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36126|NCT01507051|Secondary|Emax on PT (Measured as INR=International Normalized Ratio)|Prothrombin time – INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. Emax on PT (INR) was measured as the ratio of maximum INR divided by baseline INR.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36127|NCT01507051|Secondary|AUCBA(0-tn) (Baseline Adjusted Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUCBA(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points minus PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||s*h||Geometric Coefficient of Variation|Geometric Mean
36128|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points divided by PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio*h||Geometric Coefficient of Variation|Geometric Mean
36139|NCT01506882|Secondary|Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||days||95% Confidence Interval|Median
36129|NCT01507051|Primary|Emax,BA (Baseline Adjusted Maximum Effect) on Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax,BA on PT was measured as maximum PT (measured in seconds) minus PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||seconds||Geometric Coefficient of Variation|Geometric Mean
36130|NCT01507051|Primary|Emax (Maximum Effect) on Prothrombin Time (PT) (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax on PT was measured as the ratio of maximum PT (measured in seconds) divided by PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set||ratio||Geometric Coefficient of Variation|Geometric Mean
36131|NCT01506960|Secondary|Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).|Measured at the time of cardiac catheterization|Per protocol||mm (LCP length)|Participants|Standard Deviation|Mean
36132|NCT01506960|Primary|Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.|Measured one point in time during cardiac catheterization|||% pts with lipid on NIRS and OCT|||Number
36133|NCT01506908|Secondary|Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.|Baseline to Day 5 post treatment administration|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.||Participants|||Number
36134|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 10 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique||Score on a scale||95% Confidence Interval|Least Squares Mean
36135|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 7 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
36136|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue Baseline, 3 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
36137|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline, 1 minute post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
36138|NCT01506908|Primary|Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline,5 minutes|Intention to Treat (ITT) population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.||Score on a scale||95% Confidence Interval|Least Squares Mean
36140|NCT01506882|Secondary|Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||days||95% Confidence Interval|Median
36141|NCT01506882|Secondary|Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||days||95% Confidence Interval|Median
36142|NCT01506882|Secondary|Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||days||95% Confidence Interval|Median
36143|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||percentage of participants||95% Confidence Interval|Number
36144|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.||percentage of participants||95% Confidence Interval|Number
36145|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||percentage of participants||95% Confidence Interval|Number
36146|NCT01506882|Primary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for the primary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.||percentage of participants||95% Confidence Interval|Number
36147|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by decreasing growth differentiation factor-15 (GDF-15) in UAE subjects. Change in the GDF-15 from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.||pg/ml||Standard Deviation|Mean
36148|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces C-reactive protein (CRP) in UAE subjects. Change in the CRP from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.||ug/ml||Standard Deviation|Mean
36149|NCT01506726|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by salsalate on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at 6 months). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
36150|NCT01506726|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at 6 months). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
36151|NCT01506726|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
36152|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by salsalate on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 6 months. Scores range from 0-188 with higher scores indicating better function.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||scores on a scale||Standard Deviation|Mean
36153|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by salsalate on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to 6 months. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||t score||Standard Deviation|Mean
36154|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||change in Z-Score||Standard Deviation|Mean
36155|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||change in Z-Score||Standard Deviation|Mean
36156|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||change in Z-Score||Standard Deviation|Mean
36170|NCT01506362|Secondary|Proportion of Patients With Mucosal Healing After Completion of Study Treatment Defined as Reduction in Endoscopy Subscore of ≥ 1 From Baseline & an Absolute Endoscopy Subscore of ≤ 1 Assessed by Flexible Sigmoidoscopy.||5 weeks following first administration||||||
36157|NCT01506726|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:~“In the past month, on average, have you been feeling unusually tired during the day?” is answered “yes” and indicated as “all of the time” or “most of the time.”~“In the past month, on average, have you felt unusually weak?” is answered “yes” and indicated as “all of the time” or “most of the time.”~Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.~The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at month 6 as reported by the subject."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.||participants|||Number
36158|NCT01506726|Secondary|Change in Cognitive Outcome Measures-Trail Making Test Part B|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to month 6.|baseline; 6 months|Two subjects in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.||second per completed circle||Standard Deviation|Mean
36159|NCT01506726|Secondary|Change in Serum Hepcidin Levels|To compare the change in serum hepcidin levels between treatment groups and whether such a change is proportional to the decline in IL-6 levels. Change in the hepcidin from prior to study drug to 6 months. Positive changes represent increases in hepcidin levels and negative changes represent decreases.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and 3 subjects in the placebo arm are missing outcome measures.||ng/ml||Standard Deviation|Mean
36160|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by increasing erythropoietin (Epo) in UAE subjects. Change in the Epo from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.||mIU/ml||Standard Deviation|Mean
36161|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces markers of inflammation including IL-6 and Tumor Necrosis Factor Receptor1 (TNF-R1) in UAE subjects. Change in the marker from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.||pg/ml||Standard Deviation|Mean
36162|NCT01506726|Other Pre-specified|Association Between Change in Hemoglobin and Change in Markers of Inflammation.|To examine whether there is an association between change in hemoglobin and changes in markers of inflammation from prior to study drug to 6 months. Inflammatory markers to be measured are iL-6, Tumor Necrosis Factor alpha Receptor1 (TNF-R1), and C-reactive protein (CRP) in anemia subjects.Correlation between change in the inflammatory markers and the change in HB from prior to study drug to 6 months.|prior to study drug; 6 months|One subject from the active drug oral salsalate group and 2 subjects from the placebo arm group are missing outcomes.||correlation coefficient|||Number
36163|NCT01506726|Other Pre-specified|Change in the 6 Minute Walk Test (6MWT) Distance.|To assess the impact of treatment of anemia with oral salsalate will improve 6 minute walk test (6MWT) distance from baseline to 6 months as measured in meters and centimeters.|baseline; 6 months|Two subjects were missing outcome measure in both the active drug and the placebo arm.||meters||Standard Deviation|Mean
36164|NCT01506726|Primary|Change in Hemoglobin Level From Baseline to 6 Month Visit|To test whether the administration of oral salsalate to a subset of elderly subjects with unexplained anemia (UAE) and high interleukin (IL-6) levels will improve hemoglobin level|baseline; 6 months|||g/dL||Standard Deviation|Mean
36165|NCT01506596|Secondary|Overall Survival (OS)|OS was measured from date of consent until time of death from any cause, up to 32 months.|Date of Consent until death, up to 32 months|||months||95% Confidence Interval|Median
36166|NCT01506596|Secondary|Duration of Response|Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.|Measure of the amount of time that the criteria for response per RECIST are first met until disease progression|Since so few patients experienced a response, the pre-specified endpoint of duration of response was not analyzed.|||||
36167|NCT01506596|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Date of consent until end of study treatment, up to 32 months|||percentage of participants|||Number
36168|NCT01506596|Secondary|Progression Free Survival (PFS)|PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months.|Date of Consent until progression or death, up to 27 months|||months||95% Confidence Interval|Median
36169|NCT01506596|Primary|12-week Progression Free Rate|Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion.|Assessed after 12 weeks of study treatment|||percentage of participants||95% Confidence Interval|Number
36171|NCT01506362|Primary|Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus ≥ 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of ≤ 1|"Mayo score assesses stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment. It is assessed according to the following parameters:~Stool frequency (subscore 0-3) 0: Normal number of stools for patient~1 to 2 stools per day more than normal~3 to 4 stools more than normal~> or = to 5 stools more than normal~Rectal bleeding (subscore 0-3) 0: No blood seen~Streaks of blood with stool less than half the time~Obvious blood with stool most of the time~Blood alone passes~Endoscopic findings (subscore 0-3) 0: Normal or inactive disease~1 Mild Disease (erythema, decreased vascular pattern, mild friability) 2: Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3: Severe Disease (spontaneous bleeding, ulceration)~Physician's Global Assessment (subscore 0-3) 0: Normal~Mild disease~Moderate disease~Severe disease"|From Baseline to day 34 (end of treatment period)|||participants|||Number
36172|NCT01506323|Secondary|Five Facet Mindfulness Questionnaire (FFMQ)|FFMQ a 39-item scale that measures five components of mindfulness: observing; describing; acting with awareness; non-judging of inner experience; and non-reactivity to inner experience. Each subscale contains either 7 or 8 items that are rated on a 1 (never or very rarely true) to 5 (very often or always true) Likert scale. Items are randomly reversed scored and higher scores represent greater levels of mindfulness. Total scores range from 39 to 195.|Baseline to post-treatment (week 8); baseline to 2-months follow-up.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36173|NCT01506323|Secondary|Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)|The FACIT-SpEx was developed to assess spiritual components (e.g., harmony, meaning, purpose in life, peacefulness, faith/assurance) of quality of life using 23 items rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Total scores range from 0 to 92. Higher scores indicating greater spiritual well-being. Validity has been demonstrated by significant Pearson correlations between measures of quality of life, mood, and religious growth. It has demonstrated internal consistency reliability.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36174|NCT01506323|Secondary|Spielberger Trait Anger Inventory-Short Form|Spielberger Trait Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale used to measure anger as a personality trait. Scores range from 10 to 40 with higher scores indicating more trait anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36175|NCT01506323|Primary|PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]|PCL-M: PTSD Checklist-Military version (PCL-M) is a 17-item self-report screening instrument for PTSD symptoms related to military trauma. Items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Total scores range from 17 to 85. Higher scores indicate greater symptom bothersomeness. A score of > 50 can suggest PTSD Test-retest reliability is high (r = 0.96) and validity is adequate, with a Kappa of 0.64 agreement for PTSD diagnosis compared to the Structured Clinical Interview for DSM-IV.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36176|NCT01506323|Secondary|Spielberger State Anger Inventory-Short Form|Spielberger State Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale to measure anger as an emotional state. Scores range from 10 to 40 with higher scores indicating more anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36177|NCT01506323|Secondary|Patient Health Questionnaire (PHQ-9) for Depression|PHQ-9 is a 9-item depression screening tool based on the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and total scores range from 0 to 27. Higher scores indicate worse depression. A score of 11 or more considered probable depression and 20 or more is considered severe depression. It is well-validated and widely-used in medical settings such as primary care. The PHQ-9 includes the two major symptom domains characteristic of depression: affective and somatic symptoms.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36178|NCT01506323|Secondary|Insomnia Severity Index (ISI)|ISI is a widely used measure of insomnia with well-established reliability and validity. It consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Both categorical and continuous measures of sleep difficulties can be assessed. Items are rated on a 0-4 Likert scale with higher scores meaning greater insomnia. Total scores range from 0-28. Original results were interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia and 21-28 = severe clinical insomnia. Later recommendations for a clinical, not community sample, are a cut-off of 11 points.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36179|NCT01506323|Primary|Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of increased arousal as indicated by two or more of the following: (1) difficulty falling or staying asleep, (2) irritability or outbursts of anger, (3) difficulty concentrating, (4) hypervigilance, and/or (5) exaggerated startle response. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 40. Higher scores indicate greater severity of symptoms.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36180|NCT01506323|Primary|Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: (1) efforts to avoid thoughts, feelings, or conversations associated with the trauma, (2) efforts to avoid activities, places or people that arouse recollections of the trauma, (3) inability to recall an important aspect of the trauma, (4) markedly diminished interest or participation in significant activities, (5) feelings of detachment or estrangement from others, (6) restricted range of affect, and/or (7) sense of a foreshortened future. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 56 with higher scores indicating greater severity of avoidance.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36181|NCT01506323|Primary|Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of (1) recurrent or intrusive recollections of trauma, (2) recurrent, distressing dreams of the trauma, (3) acting as if the traumatic event were recurring like a flashback, (4) intense psychological distress at exposure to internal or external cues that resemble the trauma; and/or (5) physiological reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the trauma. Duration of these symptoms is greater than one month and symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores can range from 0 to 40 and higher scores mean greater severity of re-experiencing.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36182|NCT01506323|Primary|Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)|PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, & excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms. CAPS total score ranges from 0-136 with higher scores indicating greater symptom severity.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.||units on a scale||Standard Deviation|Mean
36183|NCT01506193|Secondary|Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.|At Day 42 after vaccination|The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.||Titers||95% Confidence Interval|Geometric Mean
36184|NCT01506193|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout study period (from Day 0 to approximately Month 4)|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
36185|NCT01506193|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
36186|NCT01506193|Secondary|Number of Subjects Reporting Any, Localised and Generalised Rashes|Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin’s surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin’s surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
36187|NCT01506193|Secondary|Number of Subjects Reporting Fever Per Half Degree|Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
36188|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
36189|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day (Days 0-14) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
36190|NCT01506193|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.||Subjects|||Number
36191|NCT01506193|Primary|Number of Seroprotected Subjects for rSBA-MenC Antibodies|Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.|At 42 days after vaccination|The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.||Subjects|||Number
36192|NCT01506193|Primary|Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus|Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.|42 days after vaccination|The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.||Subjects|||Number
36193|NCT01505881|Secondary|Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.|"Clinical efficacy outcome events presented are:~Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis"|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
36194|NCT01505881|Secondary|Percentage of Patients With Serious AEs|Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
36195|NCT01505881|Secondary|Percentage of Patients With AEs Leading to Discontinuation of Trial Drug|"Percentage of patients with Adverse Events leading to discontinuation of trial drug.~Prespecified clinical outcome events were not recorded as Adverse Events."|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
36196|NCT01505881|Primary|Percentage of Patients With Any Adverse Event (AE)|Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug||percentage of participants|||Number
36197|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 182 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.||Participants|||Number
36198|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.||Participants|||Number
36199|NCT01505647|Secondary|Number of Participants With One or More Adverse Experiences (AEs)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.||Participants|||Number
36226|NCT01504867|Secondary|Number of Participants With ARDS or Mortality Within 7 Days||within 7 days|||participants|||Number
36200|NCT01505647|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).|Day 1 (Baseline) to Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster.||Ratio||95% Confidence Interval|Geometric Mean
36201|NCT01505647|Primary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster||Units/mL||95% Confidence Interval|Geometric Mean
36202|NCT01505608|Secondary|Median Overall Survival (OS) of Participants|To determine OS and clinical benefit (CR/PR/SD) in this population|3 years|Not evaluated due to early closure. Study data does not exist.|||||
36203|NCT01505608|Secondary|Progression Free Survival (PFS) of Participants Using Days Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|Arm A- 2 subjects randomized to TMZ+I. Arm B- 6 evalubale patients in Phase 1 + 4 evaluable patients in Phase 2- all received TMZ+I+TPI||Days|||Number
36204|NCT01505608|Secondary|Measure Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|Evaluate the impact on QOL of children receiving TPI+I+TMZ|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
36205|NCT01505608|Secondary|Pharmacokinetics (PK) of TPI 287 in the Phase I Population of This Trial.|To evaluate the drug levels and pharmacokinetics (PK) of TPI 287 from blood samples at multiple time points within the first 24 hours on study.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
36206|NCT01505608|Primary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|"Phase I portion of trial- All patients enrolled to recieve TPI+I+TMZ. These patients will be added to the Phase II patients that were randomized to Arm B- Arm with TPI 287 (recieved same tx as Phase I participatns).~Phase II portion of trial- TPatients enrolled to this portion (different patients than enrolled to Phase 1) were randomized to Arm A: I+TMZ OR Arm B: TPI+I+TMZ Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|3 years|"8 enrolled to Phase 1: two were non-evaluable =6 move to analysis. Another 4 randomized to Arm B with TPI 287 in Phase 2=10 evaluable in TPI 287 analysis.~2 subjects were enrolled in the Phase 2 randomized portion of the trial to Arm A- without TPI 287. This makes 2 evaluable subjects in this analysis population (did not receive TPI 287)."||participants|||Number
36207|NCT01505608|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma.~Phase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized to TPI 287."|6 months|This group includes the 8 patients enrolled to phase 1 TPI 287 portion of the study plus the 4 additional patients randomized to TPI 287 in the Phase 2 portion = 12 patients total that received TPI 287 on this study.||participants|||Number
36208|NCT01505387|Secondary|Blood Pressure|Measured in mm Hg|24 weeks||||||
36209|NCT01505387|Secondary|Full Blood Count|Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)|24 weeks||||||
36210|NCT01505387|Secondary|Body Mass Index (kg/m^2)|Changes from baseline to end of study|24 weeks||||||
36211|NCT01505387|Secondary|Waist and Hip Circumference (cm)|Changes from baseline to end of study|24 weeks||||||
36212|NCT01505387|Primary|Mean Change in Body Weight From Baseline to End of 24 Weeks|Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction|24 weeks|||kg||Standard Deviation|Mean
36213|NCT01504997|Secondary|Incidence of Adverse Events||Participants will be followed for the duration of hospital stay, an expected average of 10 days||||||
36214|NCT01504997|Secondary|Completion Rate of Robot Assisted Surgery||During the surgery, an expected average of 5 hours||||||
36215|NCT01504997|Secondary|Relapse Free Survival||5 years||||||
36216|NCT01504997|Secondary|Overall Survival||5 years||||||
36217|NCT01504997|Primary|The Incidence of Post-operative Intra-abdominal Infectious Complications||Participants will be followed for the duration of hospital stay, an expected average of 10 days|||participants||90% Confidence Interval|Number
36218|NCT01504971|Secondary|Association of Each Endoscopic Finding With Treatment Effect of PPI|Treatment effect of PPI is assessed by changes of symptom score|2 month||||||
36219|NCT01504971|Secondary|Association of Each Endoscopic Finding With pH Monitoring Result||1 month||||||
36220|NCT01504971|Secondary|Association of Each Endoscopic Finding With Symptom Score|Symptom score is assessed by a self-reported questionnaire|1 month||||||
36221|NCT01504971|Primary|Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.|Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month|1 month|||percentage of participants||95% Confidence Interval|Number
36222|NCT01504867|Secondary|Mean Hospital Length of Stay||approximately 7 days|Intention-to-Treat||days||Standard Deviation|Mean
36223|NCT01504867|Secondary|Number of Subjects Admitted to Intensive Care Unit (ICU)||7 days|Intention-to-Treat||participants|||Number
36224|NCT01504867|Secondary|Mean Number of Subjects Who Were Ventilator-Free To Day 28||Day 28|Intention-to-Treat||participants||Standard Deviation|Mean
36225|NCT01504867|Secondary|Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization||approximately 7 days|Intention-to-Treat||participants|||Number
36230|NCT01504854|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|The ADCS-ADL is an activities of daily living inventory developed by the ADCS to assess functional performance in participants with AD. The ADCS-ADL includes some items from traditional basic ADL tests (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as instrumental (complex) activities of daily living (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading). This structured questionnaire is administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|Week 52|||units on a scale||Standard Deviation|Mean
36231|NCT01504854|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)|MRI will be used to assess the effect of treatment on rate of whole brain volume|Baseline and Week 52|ITT population||cm^3||Standard Deviation|Mean
36232|NCT01504854|Primary|Number of Adverse Events|The safety and tolerability of treatment with resveratrol will be assessed by analysis of adverse events, including symptoms, abnormal findings on physical examinations, standard laboratory tests and PK analysis of resveratrol and its major metabolites. The frequencies of adverse events or laboratory abnormalities between the participants who receive resveratrol and those receiving placebo will be compared.|Baseline, Weeks 6, 13, 19, 26, 32, 39, 45, and 52|ITT population||number of AEs|||Number
36233|NCT01504854|Post-Hoc|Change From Baseline in Cerebrospinal Fluid Amyloid β40 Concentration at 52 Weeks|Mean change from baseline in cerebrospinal fluid amyloid β40 concentration at 52 weeks|Baseline and Week 52|Post-hoc modified intention-to-treat (ITT) re-analysis of primary outcomes at Week 52 adjusting for age and AD duration in the mixed-model repeated measures model||ng/ml||Standard Deviation|Mean
36234|NCT01503749|Secondary|Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score|The efficacy (mean change in Child-Pugh score and Model For End-Stage Liver Disease score [at weeks 24]) of ultrasound-guided percutaneous portal transplantation of peripheral blood monocyte cell in cirrhotic patients. MELD Score = (0.957 * ln(Serum Cr) + 0.378 * ln(Serum Bilirubin) + 1.120 * ln(INR) + 0.643 ) * 10 (if hemodialysis, value for Creatinine is automatically set to 4.0) (minimum <9: 1.9% mortality; maximum 40 or more: 71.3% mortality). Child-Pugh score = Bilirubin (mg/dl): <2 (1 point),2-3 (2 points), >3 (3 points) + Albumin (g/dl): >3.5 (1 point),3.5-2.8 (2 points), <2.8 (3 points) + PT prolongation (INR): <4 seconds (<1.7) (1 point), 4-6 seconds (1.7-2.3) (2 points),>6 seconds (>2.3) (3 points) + Ascites: Absent (1 point), Slight (2 points), Moderate (3 points) + Encephalopathy: Absent (1 point), Mild (I-II) (2 points), Severe (III-IV) (3 points) ; Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15; higher Child-Pugh score with worse prognosis)|Baseline and Week 24|A total of 9 decompensated cirrhotic patients (5 men and 4 females, age range 45–71 years) grouped by randomization.||score||Standard Deviation|Mean
36235|NCT01503749|Primary|Number of Participants With Severe Adverse Events|No serious adverse event. Minor adverse events (not considered to be related to this study), as follows; Control: 6 events (ascites and pleural tapping, gum bleeding, ascties tapping x3, diarrhea) G-colony stimulating factor group: 6 events (percutaneous vertebroplasty, abdominal pain and nausea, hyperkalemia, ascties tapping, diarrhea, liver transplantation) Infusion of the mobilized peripheral blood mononucleated cells group: 1 event (hepatic encephalopathy)|up to 6 months|Nine patients who fulfilled the inclusion and exclusion criteria.||participants|||Number
36236|NCT01503021|Other Pre-specified|Incidence of Patients Meeting Hy's Law Criteria|The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||participants|||Number
36237|NCT01503021|Other Pre-specified|Transferrin Saturation|The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percent transferrin saturation||Standard Deviation|Mean
36238|NCT01503021|Other Pre-specified|Serum Iron|The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
36239|NCT01503021|Other Pre-specified|Ferritin|The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micrograms per liter||Standard Deviation|Mean
36240|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percent transferrin saturation||Standard Deviation|Mean
36241|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percent transferrin saturation||Standard Deviation|Mean
36292|NCT01500434|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Index Procedure|Analysis was intention to treat||percentage of stents|Participants||Number
36242|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
36243|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
36244|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
36245|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||micromoles per liter||Standard Deviation|Mean
36246|NCT01503021|Secondary|Incidence of Serious Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36247|NCT01503021|Secondary|Incidence of Systemic/Serious Infections|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36248|NCT01503021|Secondary|Incidence of Other Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36249|NCT01503021|Secondary|Incidence of Hemodialysis Vascular Access Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36250|NCT01503021|Secondary|Incidence of Composite Cardiovascular Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36251|NCT01503021|Primary|Incidence of Related Suspected Hypersensitivity Reactions|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36252|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36253|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).||percentage of participants|||Number
36263|NCT01502709|Secondary|Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam|RDC for Temporomandibular disorders (TMD) is a reliable & valid system for diagnosis of TMD, utilizing clinical procedures, diagnostic algorithms, and a dual-axis assessment comprising symptom history and physical exam. Signs and symptoms were evaluated by a trained professional and the history was obtained through use of questionnaires. In all sections and scales the higher the number reported corresponds to the more pain being experienced, therefore, a worse outcome. The clinical exam consists of facial, dental, and cervical evaluations including mandibular range of motion, Temporomandibular disorders Joint sound, and palpation of the orofacial muscles and temporomandibular joints (TMJ). Subjects are classified as TMD if they report pain in or around the temporomandibular joints or muscles of mastication for more than 3 months.|Baseline, Month 3|||Participants|||Number
36264|NCT01502709|Secondary|Mean Percentage of Time Spent in Pain From Days 1-7|The mean of measures taken from days 1-7 was calculated. Composite pain is a measure of mean pain intensity experienced and pain duration. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. Duration of pain ranges from 0 to 100% of a day. For example a pain free subject would report O pain intensity for 0% of the day.|Days 1-7|||percentage of day in pain||Standard Deviation|Mean
36265|NCT01502709|Primary|Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment|The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.|Daily Self-reports at Baseline and on Days 1 through 7|||millimeters||Standard Deviation|Mean
36266|NCT01502423|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious adverse events were collected from the time that participant signed the informed consent.|||participants|||Number
36267|NCT01502423|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
36268|NCT01502423|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
36269|NCT01502423|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
36270|NCT01502423|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection|||Percentage of Participants|||Number
36271|NCT01502423|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection.|15 minutes post injection|||cm||Standard Deviation|Mean
36272|NCT01502423|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection.|||cm||Standard Deviation|Mean
36273|NCT01502410|Secondary|Presence of BRAF Mutation or RET/PTC Rearrangement|Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline for patients with PTC, TG and TG antibody, and presence of BRAF mutation or RET/PTC rearrangement.|At baseline||||||
36274|NCT01502410|Secondary|Change in VEGF and VEGFR-2|Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline and steady state VEGF and VEGFR-2. Changes from baseline to steady state on treatment with sorafenib will be evaluated using non-parametric paired tests if there is evidence of intra-patient correlation as assessed by Spearman's rank correlation.|From baseline to day 15 of course 1||||||
36275|NCT01502410|Secondary|Pharmacokinetic (PK) Parameters of Sorafenib Tosylate|The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).|At baseline, up to 12 hours and on day 15 of course 1, and prior to odd courses||||||
36276|NCT01502410|Secondary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 5 years||||||
36277|NCT01502410|Secondary|Progression-free Survival According to RECIST Version 1.1|Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.|From date of enrollment to the date of disease progression, date of death, date of removal of all tumor by surgery or last patient contact, whichever occurs first, assessed up to 5 years||||||
36278|NCT01502410|Primary|Objective Response by RECIST Criteria v 1.1|Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 cycles (168 days)|||participants|||Number
36317|NCT01500382|Primary|Number of Participants Who Discontinued Use of Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The AST population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.||Participants|||Number
36279|NCT01502371|Secondary|Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI 50 mcg or MF DPI were included in this secondary analysis.||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
36280|NCT01502371|Secondary|Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo|The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
36281|NCT01502371|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo|PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.||Liters/minute||95% Confidence Interval|Least Squares Mean
36282|NCT01502371|Primary|Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.|Baseline and Week 12|The Full Analysis Set (FAS) population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI or Placebo were included in this primary analysis.||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
36283|NCT01502332|Secondary|Hospital Mortality|Deaths occurred during hospital stay, tested with logistic regression.|From the day of surgery up to Hospital discharge or death, with no maximum censoring.|||percentage of participants|||Number
36284|NCT01502332|Secondary|Incidence of Barotrauma|Confirmed by X-ray. Test with logistic regression|Five days after surgery|||percentage of participants|||Number
36285|NCT01502332|Secondary|Length of Hospital Stay|Days since surgery until Hospital discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the Hospital. The censoring was performed at 28 days. Patients dying before leaving the Hospital were censored as not discharged from Hospital at day 28.|From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery|||days||Inter-Quartile Range|Median
36286|NCT01502332|Secondary|Length of ICU Stay|Days since surgery until ICU discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the ICU. The censoring was performed at 28 days. Patients dying before leaving the ICU were censored as not discharged from ICU at day 28.|From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery|||days||Inter-Quartile Range|Median
36287|NCT01502332|Primary|Severity of Pulmonary Complications in the Post-operative Period|"Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication.~The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test.~Data shown are percentage of participants with pulmonary complications grade ≥ 3."|Participants were followed for the duration of hospital stay.|||percentage of participants|||Number
36288|NCT01502033|Secondary|The Clinical Global Impression - Improvement (CGI-I)|The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of 30 treatments or after last treatment in case of early withdrawal|||units on a scale||Standard Deviation|Mean
36289|NCT01502033|Secondary|Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of Treatment 30 or Last Treatment|||units on a scale||Standard Deviation|Mean
36293|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|31-365 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36294|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36295|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36296|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36297|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36298|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36299|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36300|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36301|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36302|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36303|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36304|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36305|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36306|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36307|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36308|NCT01500434|Secondary|All Cause Death||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36309|NCT01500434|Secondary|All Cause Death||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36310|NCT01500434|Secondary|All Cause Death||30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36311|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36312|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36313|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36314|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36315|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.||percentage of participants|||Number
36316|NCT01500434|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.||percentage of participants|||Number
36378|NCT01500317|Secondary|Colonic Geometric Center at 8 and 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|8 hours, 48 hours|||units on a scale||Standard Deviation|Mean
36318|NCT01500382|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The All Subjects as Treated (AST) population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.||Participants|||Number
36319|NCT01500382|Secondary|Fold-change From Baseline in Volume of Urine at First Desire to Void Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
36320|NCT01500382|Primary|Fold-change From Baseline in Maximum Cystometric Capacity Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
36321|NCT01501162|Secondary|Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines|For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.|7 days after probiotics|||EU/mL||Standard Deviation|Mean
36322|NCT01501162|Primary|Liver Enzymes(ALT)|Blood analysis was performed using standard methodologies.|7 days after probiotics|||IU/L||Standard Deviation|Mean
36323|NCT01501110|Primary|Serum T3 Levels at 48 Hours||48 hours|||ng/dL||Standard Deviation|Mean
36324|NCT01500772|Secondary|Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||48 weeks|The study was terminated before the outcome measure time point.|||||
36325|NCT01500772|Secondary|Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)|Level of detection (LOD) was defined as 10 IU/mL|12 weeks posttreatment|The study was terminated before the outcome measure time point.|||||
36326|NCT01500772|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks posttreatment|The study was terminated before the outcome measure time point.|||||
36327|NCT01500772|Primary|Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)|SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks posttreatment|The study was terminated before the outcome measure time point.|||||
36328|NCT01500746|Secondary|Pain With Lavage Treatments|After each lavage treatment, the subjects will complete a visual analogue scale that will determine the level of discomfort that they experienced during the study.|4 days||||||
36329|NCT01500746|Primary|Change in Gene Expression Analysis|A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated.|4 days||||||
36330|NCT01500746|Primary|Change in Bacterial Counts|A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed.|Baseline and at 4 days|||cfu/mL||Full Range|Mean
36331|NCT01500720|Secondary|Overall Objective Tumor Response Rate|Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.|Randomization to disease progression/occurrence (maximum 7.6 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
36332|NCT01500720|Secondary|Progression Free Rate at Week 12|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.|Week 12|ITT population.||percentage of participants||95% Confidence Interval|Number
36333|NCT01500720|Secondary|Overall Survival|Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.|From randomization to date of death (maximum 15 months)|ITT population.||months||95% Confidence Interval|Median
36394|NCT01500213|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT||percentage of participants||95% Confidence Interval|Number
36334|NCT01500720|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)|Intent-to-treat (ITT) population included all randomized participants.||months||95% Confidence Interval|Median
36335|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36336|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36337|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36338|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36339|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||participants|||Number
36340|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||participants|||Number
36341|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||participants|||Number
36342|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes|||participants|||Number
36343|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36344|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36345|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36346|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36347|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36348|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36349|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36350|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36351|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36352|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36353|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36354|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36355|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
37413|NCT01486966|Secondary|Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
36356|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36357|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36358|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36359|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36360|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36361|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36362|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36363|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36364|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36409|NCT01500031|Other Pre-specified|Device-related Clinically Significant Peripheral Embolism|"All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
36365|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36366|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36367|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
36368|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
36369|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
36370|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||sneezes||Standard Deviation|Mean
36371|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36372|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Deviation|Mean
36373|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36374|NCT01500629|Primary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes (±5 minutes)|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.||units on a scale||Standard Error|Mean
36375|NCT01500317|Secondary|Ascending Colon Emptying (AC t1/2)|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 24 hour data.|Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles|||hours||Standard Deviation|Mean
36376|NCT01500317|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours|||percentage of radio-labeled meal||Standard Deviation|Mean
36377|NCT01500317|Primary|Gastric Emptying Half-time (t1/2) at 24 Hours||24 hours|||minutes||Standard Deviation|Mean
36425|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)|from baseline to 12 months||||||
36426|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 12 months||||||
36427|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 6 months||||||
36379|NCT01500317|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours|||units on a scale||Standard Deviation|Mean
36380|NCT01500252|Secondary|Number of Revision Surgeries|This measure examined the number of reoperation in the two groups of subjects|10 years|All participants were analyzed.||participants|||Number
36381|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the five-year score from the 10 year score."|5 years postoperative to 10 years postoperative|||units on a scale||Standard Deviation|Mean
36382|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative|||units on a scale||Standard Deviation|Mean
36383|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
36384|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative|"This is the change in the patients' perceived pain between preoperative and 5 years postoperative.~The WOMAC stiffness scale has a minimum value of 0 (maximal stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
36385|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative|"This measures the change in patients' reported function from preoperative to 5 years postoperative.~The WOMAC Function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
36386|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|||units on a scale||Standard Deviation|Mean
36387|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
36388|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
36389|NCT01500252|Primary|Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.||units on a scale||Standard Deviation|Mean
36390|NCT01500226|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT||percentage of participants||95% Confidence Interval|Number
36391|NCT01500226|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT||percentage of participants||95% Confidence Interval|Number
36392|NCT01500226|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT||percentage of particpants||95% Confidence Interval|Number
36393|NCT01500213|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT||percentage of participants||95% Confidence Interval|Number
36457|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
36395|NCT01500213|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT||percentage of participants||95% Confidence Interval|Number
36396|NCT01500135|Secondary|Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. Hemostasis was assessed at 3, 4, and 5 minutes. If hemostasis was not obtained after 5 minutes a second application of IMP was applied with 3 minutes of light pressure and hemostasis was re-assessed at 8, 9 and 10 minutes.|Within 10 minutes|FAS included all randomized participants. Participants who did not achieve hemostasis by 10 minutes were censored.||minutes||95% Confidence Interval|Median
36397|NCT01500135|Secondary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.|Within 5 minutes|FAS included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 5 minutes.||percentage of participants||95% Confidence Interval|Number
36398|NCT01500135|Primary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.|Within 3 minutes|Full Analysis Set (FAS) included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 3 minutes.||percentage of participants||95% Confidence Interval|Number
36399|NCT01500109|Secondary|Pain Scores Using the Age-appropriate Pain Scale|The investigators will also be looking for the presence of pruritus, nausea, vomiting and/or sedation|24 hours||||||
36400|NCT01500109|Primary|Opioid (Fentanyl and Morphine) Consumption|The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in morphine equivalents).|intraoperative period and first postoperative 24 hours|||mcg•kg-1||95% Confidence Interval|Mean
36401|NCT01500083|Primary|Number of Adverse Events||Up to 266 days|APTS||number of adverse events|||Number
36402|NCT01500031|Other Pre-specified|OffRoad System Use Length of Time|"From time of positioning balloon catheter introduced in the body until time final OffRoad component removed."|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 1 participant was not evaluable (No data available).||minutes||Standard Deviation|Mean
36403|NCT01500031|Other Pre-specified|Overall Procedure Time|Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body.|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis.||minutes||Standard Deviation|Mean
36404|NCT01500031|Other Pre-specified|Device-related Dissection, Grade C or Greater|"Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material.~Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles.~Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material.~Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow.~Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
36405|NCT01500031|Other Pre-specified|Target Lesion Revascularization Due to a Complication|Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
36406|NCT01500031|Other Pre-specified|Acute Procedure Success|Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)}|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
36407|NCT01500031|Other Pre-specified|All Adverse Events|All adverse events (AEs) reported by the centers.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||adverse events|||Number
36408|NCT01500031|Other Pre-specified|Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb|"All Major amputations related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
36458|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
36410|NCT01500031|Other Pre-specified|Device-related Perforation Requiring Intervention|"All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
36411|NCT01500031|Other Pre-specified|Device-related Death|All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).||percentage of participants|||Number
36412|NCT01500031|Primary|Effectiveness (On the Day of Procedure)|Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)|Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis.||percentage of participants||95% Confidence Interval|Number
36413|NCT01500031|Primary|Composite Rate of Major Adverse Events|"Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above).~Events are based on data adjudicated by a Clinical Event Committee."|30 days|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day)||percentage of participants|||Number
36414|NCT01499862|Primary|Ambulation Speed|Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||meters per second (m/s)|||Number
36415|NCT01499862|Secondary|Step Length|The length of the patient's average step, in meters, as measured during comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Meters|||Number
36416|NCT01499862|Secondary|Five Times Sit to Stand Test (5 x STS)|The time, in seconds, for the patient to rise from a seated to full standing position and return to sitting five times in rapid succession. This evaluation is called the Five Times Sit to Stand Test (5 x STS)|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Seconds|||Number
36417|NCT01499862|Secondary|Timed Up and Go (TUG) Test|The time, in seconds, for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn around, walk back to the chair, and sit down. This evaluation is called the Timed Up and Go test (TUG). The patient may wear their usual footwear and use any aids (canes, walkers, etc.) they typically employ for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Seconds|||Number
36418|NCT01499862|Secondary|6 Minute Walk Test (6 MWT)|The total distance walked by the patient, in meters, as obtained by the Six (6) Minute Walk Test (6 MWT). The 6 MWT is performed over level ground, using any walking aids (canes, walkers, etc.) the patient requires for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.||Meters|||Number
36419|NCT01499849|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rates in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT||percentage of participants||95% Confidence Interval|Number
36420|NCT01499849|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours)phase of CINV|0 to 24 hours|MITT||percentage of participants||95% Confidence Interval|Number
36421|NCT01499849|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT||percentage of participants||95% Confidence Interval|Number
36422|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 6 months||||||
36423|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 12 months||||||
36424|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000|from baseline to 6 months||||||
36428|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months|||difference between ratios||Standard Deviation|Mean
36429|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months|||difference between ratios||Standard Deviation|Mean
36430|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months|||difference between two ratios||Standard Deviation|Mean
36431|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months|||difference between two ratios||Standard Deviation|Mean
36432|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 12 months|||no specific units||Standard Deviation|Mean
36433|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 6 months|||no specific units||Standard Deviation|Mean
36434|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 1 week|||no specific units||Standard Deviation|Mean
36435|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 12 months|||g/l||Standard Deviation|Mean
36436|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 6 months|||g/l||Standard Deviation|Mean
36437|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 1 week|||g/l||Standard Deviation|Mean
36438|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 12 months|||micromol/l||Standard Deviation|Mean
36439|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 6 months|||micromol/l||Standard Deviation|Mean
36440|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 1 week|||micromol/l||Standard Deviation|Mean
36441|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
36442|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
36443|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
36444|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months|||mmHg||Standard Deviation|Mean
36445|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months|||mmHg||Standard Deviation|Mean
36446|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months|||mmHg||Standard Deviation|Mean
36447|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months|||mmHg||Standard Error|Mean
36448|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)|from baseline to 12 months|||mmHg||Standard Error|Mean
36449|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months|||percentages||Standard Deviation|Mean
36450|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months|||difference between percentages||Standard Deviation|Mean
36451|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months|||percentages||Standard Deviation|Mean
36452|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months|||percentages||Standard Deviation|Mean
36453|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
36454|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 12 months|||mmHg||Standard Deviation|Mean
36455|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
36456|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 6 months|||mmHg||Standard Deviation|Mean
36470|NCT01499810|Primary|Number of Serious Adverse Events|A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.|from baseline to 12 months|||Events|||Number
36471|NCT01499810|Primary|Change in Office Systolic BP||from baseline to 12 months|All patients who completed 12 month assessment according to the protocol.||mmHg||Standard Deviation|Mean
36472|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod||participants|||Number
36473|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod||participants|||Number
36474|NCT01499667|Secondary|Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion|Gadolinium-enhancing lesions will be measured on post-contrast T1-weighted brain MRI scans|8 weeks and 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.||Number of Gd enhanced T1 Lesions||Standard Deviation|Mean
36475|NCT01499667|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group|Kurtzke’s Expanded Disability Status Scale (EDSS) measures the changes in neurologic impairment, either chronic (progression over time), or acute (MS relapses). The EDSS steps range from 0 (normal) to 10 (death due to MS). Relapse severity is assessed based on severity of neurologic impairment as evaluated using the EDSS.|Baseline to week 16 and week 32|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.||Units on a scale||Standard Deviation|Mean
36476|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline)|Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated for 24 weeks from baseline.|Baseline up to 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization||Count of Active T2 Lesions||Standard Deviation|Mean
36477|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated for first 8 weeks of fingolimod treatment.|Number of active T2 lesions during 8 wks of fingolimod treatment|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization||Count of Active T2 Lesions||Standard Deviation|Mean
36478|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated from baseline to beginning of treatment.|8, 12 and 16 weeks (number of active T2 lesions during the washout period only)|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization||Count of active T2 lesions||Standard Deviation|Mean
36479|NCT01499667|Primary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment|Active lesions were measured on brain MRI scans, performed at week 8, compared to the prior scan. The primary variable was analyzed by fitting a negative binomial regression model adjusted for washout group.|Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment|The modified Full Analysis Set (mFAS) included all patients in the Full Analysis Set who completed 8 weeks of fingolimod treatment and provided an MRI scan at this time point. The analysis of primary variable was performed on the mFAS.||Count of Active T2 Lesions||Standard Deviation|Mean
36480|NCT01499654|Post-Hoc|Injection and Scan Times|Time in minutes between doses of resting Tc-99m sestamibi doses and image scanning.|Baseline|||minutes||Standard Deviation|Mean
36481|NCT01499654|Post-Hoc|Resting Full-Tracer Dose|Amount of the standard, clinically-accepted, full-dose Tc-99m sestamibi dose administered|Baseline|Entire Cohort||millicurie||Standard Deviation|Mean
36482|NCT01499654|Primary|Segments With Resting Perfusion Defect|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect.|Baseline|||segments||Standard Deviation|Mean
36483|NCT01499654|Secondary|Diagnostic Confidence Score|Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline|||units on a scale||Standard Deviation|Mean
36484|NCT01499654|Secondary|Image Quality Score|Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline|||units on a scale||Standard Deviation|Mean
36789|NCT01495858|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
36485|NCT01499654|Primary|Sum Rest Score|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.|Baseline|||units on a scale||Standard Deviation|Mean
36486|NCT01499576|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.|up to 1week after the acetic acid chromoendoscopy|||participants|||Number
36487|NCT01499576|Secondary|Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists|"The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.~We calculate the Kappa index of agreement for the acetic acid chromoendoscopy."|One month after the completion of the study|||Kappa index of agreement|Participants||Number
36488|NCT01499576|Primary|Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy|Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.|3 months after the completion of the study (a pathologist reviewed all the biopsy slide)|||percentage of lesions|Participants||Number
36489|NCT01499498|Secondary|Number of Patients With Adverse Events|The number of repeated adverse events will be used to assess the safety of the drugs in combination|Day 1 - 16|||participants|||Number
36490|NCT01499498|Primary|Boceprevir Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16|||ng/mL||95% Confidence Interval|Geometric Mean
36491|NCT01499498|Primary|Sildenafil Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16|||ng/mL||95% Confidence Interval|Geometric Mean
36492|NCT01499498|Primary|Boceprevir Alone Maximum Plasma Concentration|Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)|day 10-15|||ng/mL||95% Confidence Interval|Geometric Mean
36493|NCT01499498|Primary|Sildenafil Alone Maximum Plasma Concentration|Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 1|||ng/mL||95% Confidence Interval|Geometric Mean
36494|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study|Number of days between first visit with response to last consecutive visit with partial or complete response. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|up to Week 52|The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).||days||Standard Deviation|Mean
36495|NCT01499355|Secondary|Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period|AEs that had an onset on or after dosing of BIIB023 or placebo, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Week 12 to Week 56|The safety population was defined as all subjects who received at least 1 dose of study treatment (including placebo or BIIB023).||participants|||Number
36496|NCT01499355|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period|AEs that had an onset on or after dosing of MMF on run-in Day 1 up to the first double-blind dose, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Day 1 to Week 12|All enrolled participants||participants|||Number
36514|NCT01499290|Primary|Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|The CE analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.||Participants|||Number
36497|NCT01499355|Secondary|Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52|Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): > 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and > 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory, and presence of cellular casts (RBC or WBC). Inactive urinary sediment is defined as: < 5 RBC/HPF and < 5 WBC/HPF, or within the laboratory reference range, and no cellular casts (no RBC or WBC casts).|Baseline, Week 52|Participants with active urinary sediment at Day 1 in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants||90% Confidence Interval|Number
36498|NCT01499355|Secondary|Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52||Baseline (Day 1), Week 52|Participants with a uPCR > 3.0 mg/mg at Baseline in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes those who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants||90% Confidence Interval|Number
36499|NCT01499355|Secondary|Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52|Onset of renal response was calculated as weeks elapsed from baseline date to first visit where renal response was achieved. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|Baseline to Week 52|Participants in the ITT population who achieved a renal response at Week 52. The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).||weeks||Full Range|Median
36500|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52|Duration of response was calculated as the days in between the date of Week 52 visit and the date when the participant last became complete renal responder on or before Week 52 visit. Complete renal response: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||Participants|||Count of Participants
36501|NCT01499355|Secondary|Percentage of Participants Who Achieve Complete Renal Response at Week 52|Complete renal response is defined as uPCR < 0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants|||Number
36502|NCT01499355|Primary|Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52|Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) < 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range).|Week 52|Participants in the modified intent-to-treat (mITT) population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)||percentage of participants||90% Confidence Interval|Number
36503|NCT01499303|Primary|Objective Response Rate|Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis.|Week 8|Full analysis set - all randomised patients||Patients||95% Confidence Interval|Number
36504|NCT01499290|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug|PK analysis set||(NG/ML)||Full Range|Geometric Mean
36505|NCT01499290|Secondary|Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day.|Test of Cure: 1 to 14 days after start of study drug|Clinically evaluable (CE) with fever, defined as >38ºC at study entry.||Participants|||Number
36538|NCT01499199|Primary|Plasma DTG Unbound Fraction at Week 2 and Week 16|The unbound fraction of DTG in plasma (presented as a percentage of unbound [i.e., free DTG not bound to cellular proteins] DTG plasma concentration over paired plasma total DTG concentration) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population||Percentage||Full Range|Median
36506|NCT01499290|Secondary|Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|Microbiological responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
36507|NCT01499290|Secondary|Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
36508|NCT01499290|Secondary|Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
36509|NCT01499290|Secondary|Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug.|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
36510|NCT01499290|Secondary|Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to a surgical review panel (SRP) assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
36511|NCT01499290|Secondary|Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
36512|NCT01499290|Secondary|Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|Extended ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, pathogen in the initial/prestudy culture, regardless of susceptibility.||Participants|||Number
36513|NCT01499290|Secondary|Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, susceptible pathogen in the initial/prestudy culture.||Participants|||Number
36539|NCT01499199|Primary|Unbound DTG Plasma Concentrations at Week 2 and Week 16|Unbound (free, not bound to cellular proteins) plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population||Nanograms per milliliter (ng/mL)||Full Range|Median
36515|NCT01499290|Primary|Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|TOC: 28 to 35 days after start of study drug|The MITT analysis set included all randomized patients who met the disease definition of cIAI and who received any amount of study drug.||Participants|||Number
36516|NCT01499290|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.||Participants|||Number
36517|NCT01499277|Secondary|Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME|Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set|7 to 20 days after the last dose of study drug|||Participants|||Number
36518|NCT01499277|Secondary|Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set|The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.|48 to 72 hours after first dose of study drug|||Participants|||Number
36519|NCT01499277|Secondary|Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC|The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.|21 to 42 days after the last dose of study drug|||Participants|||Number
36520|NCT01499277|Secondary|Clinical Response at EOT in CE Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or +1 day)|||Participants|||Number
36521|NCT01499277|Secondary|Clinical Response at End of Treatment (EOT) in MITT Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or + 1 day)|||Participants|||Number
36522|NCT01499277|Secondary|Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set|Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically evaluable (ME)||Participant|||Number
36523|NCT01499277|Secondary|Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set|Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically modified-intent-to-treat (mMITT)||Participant|||Number
36524|NCT01499277|Primary|Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Clinical evaluable (CE)||Participant|||Number
36525|NCT01499277|Primary|Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Modified intent-to-treat (MITT)||Participant|||Number
36526|NCT01499199|Secondary|Number of Participants With Treatment-emergent Genotypic and Phenotypic Resistance to DTG and Other Antiretroviral Therapy (ART)|The number of participants with treatment-emergent genotypic and phenotypic resistance to integrase inhibitors (INIs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transctiptase inhibitors (NNRTIs), and protease inhibitors (PIs) was assessed.|Baseline through the date the last participant completed Week 96|Protocol Defined Virologic Failure (PDVF) Genotypic Population (Integrase inhibitor [IN] Results at Baseline and PDVF): The PDVF Genotypic and Phenotypic populations consisted of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time of PDVF||participants|||Number
36537|NCT01499199|Primary|DTG Concentrations in CSF at Weeks 2 and Week 16|CSF is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma PK sampling. DTG concentration in CSF were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|CSF DTG Concentration Population: all participants receiving DTG who underwent lumbar puncture during the study and provided evaluable DTG CSF concentration data. One participant was excluded from the analysis at Week 2.||Nanograms per milliliter (ng/mL)||Full Range|Median
36527|NCT01499199|Secondary|The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Any abnormal laboratory test result (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., electrocardiograms [ECGs], radiological scans, vital sign measurements), including those that worsen from Baseline, and were felt to be clinically significant in the medical and scientific judgment of the investigator, were recorded as AEs or SAEs. Clinically suspected cases of hypersensitivity to ABC were also SAEs.|Baseline (BL) through the date the last participant completed Week (W) 96 + the follow-up visit (if applicable)|Safety Population: all participants who received at least one dose of study medication. Participants were analyzed according to the actual treatments received. Participants were not excluded from this population as a result of changes to the background regimen.||participants|||Number
36528|NCT01499199|Secondary|Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences|The number of participants who reported a new or recurrent Centers for Disease Control and Prevention (CDC) Class B or Class C condition was assessed from Baseline though the date the last participant completed Week 96 + the follow-up visit (if applicable). Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition.|Baseline through the date the last participant completed Week 96 + follow-up visit (if applicable)|ITT-E Population||participants|||Number
36529|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96|The absolute value for CD48+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 12, Week 16, Week 24, Week 48, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 12, 16, 24, 48, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.||cells/mm^3||Full Range|Median
36530|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.||cells/mm^3||Full Range|Median
36531|NCT01499199|Secondary|Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall|The Pearson Correlation Coefficient is a measure of the correlation between CSF DTG concentrations and absolute values/changes from Baseline in CSF HIV-1 RNA at Week 2 and Week 16. CSF HIV-1 RNA is measured as log10 copies per milliliter (copies/mL).|From Baseline to Week 16|CSF Pharmacodynamic Population. The overall analysis combines Week 2 and Week 16 data; thus, analysis was performed on 22 data points from 11 participants.||Pearson Correlation Coefficient||90% Confidence Interval|Mean
36532|NCT01499199|Secondary|Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16|The relationship between HIV-1 RNA suppression in plasma and the CSF was measured as a comparison and as a change in the number of participants in the cross tabulation of <50 copies/mL in plasma, <50 copies/mL in CSF, >=50 copies/mL in plasma, and >=50 copies/mL in CSF at Baseline, Week 2, and Week 16.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time point were assessed.||participants|||Number
36533|NCT01499199|Secondary|Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as absolute values and change from Baseline in HIV-1 RNA levels in CSF at Week 2 and Week 16. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time points were assessed.||log10 c/mL||Full Range|Median
36534|NCT01499199|Secondary|Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as the number of participants with HIV-1 RNA <50 copies/milliliter (c/mL).|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population: all participants who received DTG and underwent lumbar puncture during the study and provided CSF HIV-1 RNA data. Only those participants available at the indicated time points were assessed.||participants|||Number
36535|NCT01499199|Secondary|Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The plasma samples were collected at the Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96 visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.||log10 copies/mL||Full Range|Median
36536|NCT01499199|Secondary|Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16|HIV-1 RNA response in plasma was measured as the number of participants with HIV-1 RNA less than 50 c/mL at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16.|Baseline; Weeks 2, 4, 8, 12, and 16|Intent -to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of investigational product||participants|||Number
37960|NCT01478009|Primary|Frequency of ILI(Influenza Like Illness)|Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.|12 weeks|per protocol analysis||participants|||Number
36540|NCT01499199|Primary|Total DTG Plasma Concentrations at Week 2 and Week 16|Total plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population: all participants receiving DTG who underwent PK sampling during the study and provided evaluable DTG plasma concentration data||Micrograms per milliliter (µg/mL)||Full Range|Median
36541|NCT01499199|Primary|The Ratio of Total and Unbound DTG Concentrations Between Cerebrospinal Fluid (CSF) and Plasma at Week 2 and Week 16|Cerebrospinal fluid (CSF) is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma pharmacokinetic (PK) sampling. The ratio (presented as a percentage) of CSF DTG concentration over paired plasma total DTG concentration (RCSF_plasma) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma/CSF DTG Paired Sample Population: participants (par.) with plasma and CSF samples collected post-dose and within 1 hour of each other (one par. withdrew prior to Week 2 and did not contribute to PK assessments). One par. was excluded from the analysis at Week 2 because his/her paired samples were not collected within the specified timeframe.||percentage||Full Range|Median
36542|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Stairs Score|Change in stairs score as captured by the Walking Impairment Questionnaire (WIQ) stairs subscale. This scale item asks the subject to describe the degree of difficulty climbing one, two, or three flights of stairs in the past week. A flight of stairs is defined as 14 steps. A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, 5) Unable to Do, or 6) Didn Do for Other Reasons. The items on the subscale are weighted according to the difficulty of the task. The stairs score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|"Four people in the nebivolol group and 1 person in the metoprolol group did not complete the items in the Stairs WIQ subscale therefore they were excluded from the analysis. One person in the metoprolol succinate group withdrew consent before the end of the study so they were also excluded from the final analysis."||units on a scale||Standard Deviation|Mean
36543|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Speed Score|Change in speed score as captured by the Walking Impairment Questionnaire (WIQ) speed score subscale. In the walking speed component, the degree of difficulty walking is ranked on a 0 to 4 scale where speed is assessed for each of the following speeds: at the following speeds: 1, slowly; 2, average speed; 3, quickly; or 4, running or jogging 1 block. Zero represents the inability to walk the specified speed, and 4 represents no difficulty. The items on the subscale are weighted according to the difficulty of the task. The speed score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group. One patient in the nebivolol group failed to complete the items in the WIQ speed score subscale, therefore, only 8 patients were included in the analysis for this outcome.||units on a scale||Standard Deviation|Mean
36544|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score|Change in distance score as captured by the Walking Impairment Questionnaire (WIQ) distance score subscale. The degree of difficulty in the walking of specific distances is ranked on a 0 to 4 Likert scale, in which 0 represents the inability to walk the distance and 4 represents no difficulty. A Likert scale is an ordinal scale of consecutive, equidistant, numerical values (ie, 0 to 4). The distances assessed in the WIQ range from walking indoors around the home to walking 5 blocks (1500 feet). The items on the subscale are weighted according to the difficulty of walking. The distance score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||units on a scale||Standard Deviation|Mean
36545|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain|Change in buttock pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||units on a scale||Standard Deviation|Mean
36546|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change Calf Pain|Change in calf pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||units on a scale||Standard Deviation|Mean
36547|NCT01499134|Secondary|Claudication Onset Time (COT)|Change in measurement of claudication onset time (COT). The COT is defined as the time when a patient first experienced pain walking during a treadmill test.|Baseline COT is measured at the time of enrollment and again at the final study visit at 26 weeks.|Final measurements of COT in the metoprolol succinate group excludes one subject who did not experience claudication while walking during the treadmill test, and one subject who withdrew consent prior to the end of the study, therefore, only 6 participants are included in the analysis for this group.||seconds||Standard Deviation|Mean
36548|NCT01499134|Secondary|Ankle-brachial Index (ABI)|Change in measurement of Ankle-brachial index (ABI). The ABI is the ratio of the blood pressure measured in the lower legs to the blood pressure measured in the arms.|Baseline ABI is measured at the time of enrollment and again at the final study visit at 26 weeks|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||Ankle-Brachial Index||Standard Deviation|Mean
36549|NCT01499134|Primary|Peak Walking Time (PWT)|Change in peak walking time (PWT) is measured in seconds. The PWT is defined as when walking on a treadmill cannot continue due to maximal leg pain, resulting in the discontinuation of the treadmill test.|Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.||seconds||Standard Deviation|Mean
36550|NCT01499095|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6 up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants who were receiving HOE901­U300 (Adaptable dosing intervals or Fixed dosing intervals). Missing data imputed using last observation carried forward.||percentage of hemoglobin||Standard Error|Least Squares Mean
36551|NCT01499095|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
36552|NCT01499095|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
36553|NCT01499095|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.||U/kg||Standard Error|Least Squares Mean
36554|NCT01499095|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time­point of 8­point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Only participants from the mITT population with a value at baseline and at the specified timepoint were analyzed (represented by n=X, X in the category titles). Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
36555|NCT01499095|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
36556|NCT01499095|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
36557|NCT01499095|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
36558|NCT01499095|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.||percentage of mean||Standard Error|Least Squares Mean
36559|NCT01499095|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.||mmol/L||Standard Error|Least Squares Mean
37961|NCT01477892|Secondary|Adverse Reaction|bradycardia, hypotension, apnea, desaturation|during and after 10min of remifentanil continous infusion|||participants|||Number
36560|NCT01499095|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis.|Week 9 Up to Month 6|Modified intent­to­treat population.||percentage of participants|||Number
36561|NCT01499095|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of hemoglobin||Standard Error|Least Squares Mean
36562|NCT01499082|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.|Month 6 Up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants enrolled in the substudy and who were receiving HOE901-U300 (Adaptable dosing intervals or Fixed dosing intervals).||percentage of hemoglobin||Standard Error|Least Squares Mean
36563|NCT01499082|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.||percentage of participants|||Number
36564|NCT01499082|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
36565|NCT01499082|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.||U/kg||Standard Error|Least Squares Mean
36566|NCT01499082|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point. Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
36567|NCT01499082|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
36568|NCT01499082|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
36569|NCT01499082|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of participants|||Number
36570|NCT01499082|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.||percentage of mean||Standard Error|Least Squares Mean
36571|NCT01499082|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.||mmol/L||Standard Error|Least Squares Mean
44994|NCT01385995|Secondary|Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham|Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)|20 weeks|||mg/dL||Standard Deviation|Mean
36572|NCT01499082|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).|Week 9 Up to Month 6|Modified intent-to-treat population.||percentage of participants|||Number
36573|NCT01499082|Primary|Change in HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.||percentage of hemoglobin||Standard Error|Least Squares Mean
36574|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period|48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."||percentage of subjects|||Number
36575|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time|24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."||percentage of subjects|||Number
36576|NCT01498822|Secondary|Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period||From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."||months||Full Range|Median
36577|NCT01498822|Primary|Percentage of Subjects With a Treatment Failure|Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.|Week 0 (First Dose) to Week 50|Per Protocol Set (PPS) consisted of all subjects who received at least 1 (partial) dose of study mediaction, returned at least 1 post-Baseline seizure diary and had no important protocol deviations. Subjects who discontinued the study before Week 50 for any reason other than treatment failure were excluded from the PPS.||percentage of subjects|||Number
36578|NCT01498744|Secondary|Complication to Antibiotic Regime||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.||participants|||Number
36579|NCT01498744|Secondary|Additional Skin or Soft Tissue Infections in Household Contacts||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.||participants|||Number
36580|NCT01498744|Secondary|Additional Skin and Soft Tissue Infections in Patient|The outcome measure was reported by responding to a yes/no|Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included here.||participants|||Number
36581|NCT01498744|Primary|Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.||At office visit 10-14 days post operation|Only participants that had data collected for this outcome measure are included above.||participants|||Number
36582|NCT01498692|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death.|Duration of Hospital Stay (average 1-2 days)|Analysis was intention to treat||percentage of participants|||Number
36583|NCT01498692|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|During the index procedure (minutes)|Analysis was intention to treat||percentage of stents|Participants||Number
36584|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with ST|||Number
36585|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with ST|||Number
36586|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC)Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with ST|||Number
36587|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TVR|||Number
36588|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TVR|||Number
36589|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TVR|||Number
36590|NCT01498692|Secondary|Target Lesion Revascularization TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TLR|||Number
36591|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TLR|||Number
36592|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with TLR|||Number
36593|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36594|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36595|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36596|NCT01498692|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36597|NCT01498692|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36598|NCT01498692|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36650|NCT01498120|Primary|Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.||subjects|||Number
38317|NCT01474200|Secondary|CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days|Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge|||Rehospitalizations/100 Pt-Days at Risk|||Number
36599|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with MI|||Number
36600|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with MI|||Number
36601|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants with MI|||Number
36602|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36603|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36604|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36605|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.||percentage of participants|||Number
36606|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
36607|NCT01498692|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.|12 Months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.||percentage of participants|||Number
36608|NCT01498679|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
36668|NCT01497665|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability||Upon enrollment through end of study period (1 year after last patient is enrolled)|||participants|||Number
36609|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily diary by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
36610|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
36611|NCT01498679|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. A Repeated Measures analysis adjusted for Baseline, region, sex, age, treatment, week, week by Baseline interaction, and week by treatment interaction was used.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. Only those participants who had AM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization and were available at the indicated time point were assessed.||L/min||Standard Error|Least Squares Mean
36612|NCT01498679|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
36613|NCT01498653|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
36614|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had symptom-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
36626|NCT01498588|Primary|Pathologic Complete Response Rate at the Time of Surgery|Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist’s standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR.|Average of 24 weeks|Pathology information at the time of definitive resection was available for six of seven patients. One patient was ultimately lost to follow-up.||participants|||Number
36741|NCT01496274|Secondary|Annualized Spontaneous Bleeding Events Compared Between 7 Day Prophylactic and Extended Regimens|Median number of spontaneous bleeds per year per subject comparing 7-, 10- and 14- day prophylactic regimens.|During treatment, between median 240 and 386 days per subject.|Efficacy Population||bleeds/year/subject||Inter-Quartile Range|Median
36615|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had rescue-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
36616|NCT01498653|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had PM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.||L/min||Standard Error|Least Squares Mean
36617|NCT01498653|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
36618|NCT01498640|Secondary|Recurrence of Contracture|Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.|Day 365|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed||joints|Participants||Number
36619|NCT01498640|Secondary|Subject Global Assessment of Satisfaction|Subject global assessment of overall treatment satisfaction|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||participants|||Number
36620|NCT01498640|Secondary|Physician Global Assessment of Improvement|Physician global assessment of change (improvement) in subject's Dupuytren's contracture|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||participants|||Number
36621|NCT01498640|Primary|Change in Range of Motion|Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||degrees||Standard Deviation|Mean
36622|NCT01498640|Primary|Percent Change From Baseline in Degree of Contracture|Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||percentage of contracture change||Standard Deviation|Mean
36623|NCT01498640|Primary|Clinical Success|Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500|30 days after last injection|Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure||percentage of particpants||95% Confidence Interval|Number
36624|NCT01498601|Primary|Hospital Acquired Pneumonia Occurrences|Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.|10 months|||participants|||Number
36625|NCT01498588|Secondary|Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events)|Toxicity of chemotherapy at each physician visit using Common Toxicity Criteria for Adverse Effects (CTCAE) criteria.|Through 20 weeks of chemotherapy|||participants|||Number
36648|NCT01498185|Primary|Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7|7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.|From Baseline to Day 7|All randomized participants who received study medication and had nonmissing values at baseline and Day 7||mg/dL||Standard Error|Mean
36627|NCT01498575|Primary|Late Driving Performance in On-road Assessment (ODA) Test|The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.|24 weeks after enrollment|512 teen-parent dyads were eligible and agreed to participate. Of these, 217 teens were scheduled to complete the ODA (128 were randomized to Teen Driving Plan (TDP), 89 to Usual Practice). Participant attrition over the time of the study resulted in 151 teens (86 TDP and 65 control) completing the 24-week ODA.||Participants|||Number
36628|NCT01498458|Secondary|Clinical Benefit Rate (CBR)|To determine the clinical benefit rate (CBR) in patients with measurable disease. CBR consists of complete response , partial response, and stable disease lasting greater than 24 weeks. All patients are included when determining this rate. 2 patients were on study treatment for a long time.Hence the outcome rate of 25 percent ( 2 from 8 patients)|3 years|All patients are included when determining this rate.||percentage of participants|||Number
36629|NCT01498458|Secondary|Objective Response Rate (ORR)|To determine the objective response rate (ORR) in patients with measurable disease. ORR consists of complete response and partial response according to the RECIST criteria. Complete Response refers to the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to less than 10 mm. Partial Response refers to an at least 30 percent decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|3 years|All patients are included when determining this rate.||percentage of participants|||Number
36630|NCT01498458|Secondary|Other Toxicity of the Combination of Pazopanib and Capecitabine||3 years|6 patients experience 6 Serious Adverse Reactions||participants|||Number
36631|NCT01498458|Secondary|Hematological Toxicity of the Combination of Pazopanib and Capecitabine||3 years|||Number of cycles|||Number
36632|NCT01498458|Secondary|Dose-limiting Toxicity (DLT)||3 years|||participants|||Number
36633|NCT01498458|Primary|Maximum Tolerable Dose (MTD) of Pazopanib|The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.|3 years|||mg|||Number
36634|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. This was measured at visit 24(Day 57).|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.||percentage of patients|||Number
36635|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 206.||days||Inter-Quartile Range|Median
36636|NCT01498419|Secondary|Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm.||8 weeks|The Safety population was analyzed for this outcome.||percentage of participants|||Number
36637|NCT01498419|Secondary|The Rate of Change in Time to Sputum Culture Positivity (TTP) Through 8 Weeks in the MGIT System in Sputum Over 8 Weeks in Participants as Derived From a Non-linear Regression Model.|Measurement of TTP in liquid culture media Mycobacteria growth indicator tube (MGIT) using standard procedures|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 179.||log10hours/day||95% Confidence Interval|Mean
36638|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. (Day 57)|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.||percentage of participants|||Number
36639|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media|liquid culture = Mycobacteria growth indicator tube (MGIT) Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants included for this outcome was 206.||days||Inter-Quartile Range|Median
36640|NCT01498419|Primary|The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment.|The primary efficacy endpoint was bactericidal activity characterized by the daily rate of change in mean log10CFU counts during 8 weeks of treatment (bactericidal activity assessed by CFU on solid media for days 0–56).|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 173.||log10CFU/ml/day||95% Confidence Interval|Mean
36641|NCT01498185|Secondary|Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. MR was calculated as the ratio of metabolite to parent AUC(TAU), corrected for molecular weights of dapagliflozin and dapagliflozin 3-O-glucuronide (408.82 and 584.99, respectively).|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||(ng*h/mL):(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
36642|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
36643|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||hour||Full Range|Mean
36644|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
36645|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
36646|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||hour||Full Range|Mean
36647|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles||ng/mL||Geometric Coefficient of Variation|Geometric Mean
36649|NCT01498120|Primary|Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.||subjects|||Number
36651|NCT01498068|Secondary|Number of Participants in Each Specific Category of Treatment Outcome|Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =>25 IU/mL during follow-up period after previous HCV RNA<25 IU/mL at planned end of treatment(EOT)[Week 24 or Week 48] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase >1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA has previously become <25 IU/mL during treatment).Stopping rule defined as HCV RNA value >1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA <25 IU/mL at actual EOT and never HCV RNA =>25 IU/mL thereafter.|From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
36652|NCT01498068|Secondary|Number of Participants With Virologic Failure|Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.|Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
36653|NCT01498068|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48|The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.|Weeks 8, 12, 24, 32, 40 and 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."||Participants|||Number
36654|NCT01498068|Secondary|Number of Participants With Rapid Virologic Response (RVR) at Week 4|A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4|Week 4|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
36655|NCT01498068|Secondary|Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Changes from baseline in log10 HCV RNA levels were calculated.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."||Log 10 IU/mL||Full Range|Median
36656|NCT01498068|Primary|Number of Participants With Extended Rapid Virologic Response (eRVR)|A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.|Week 4 and Week 12|Full analysis (FA) population: All participants who received at least one dose of the study medication.||Participants|||Number
36657|NCT01497938|Primary|The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)|An event is identified as: LGS feature in the correct setting; CGM values <= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was <= 65 mg/dL; The rate of change before reaching sensor glucose value of <= 65 mg/dL was <= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value <= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data.|5 months|||mg/dL x min||Standard Deviation|Mean
36658|NCT01497938|Primary|Change in A1C From Baseline to End of Study Participation|The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.|5 months|||Percent||Standard Deviation|Mean
36659|NCT01497899|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 24 and 48||Baseline; Weeks 24 and 48|Full Analysis Set||cells/uL||Standard Deviation|Mean
36660|NCT01497899|Secondary|Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48||Baseline; Weeks 24 and 48|Full Analysis Set||log10 copies/mL||Standard Deviation|Mean
36661|NCT01497899|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set||percentage of participants|||Number
36662|NCT01497899|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants randomized to the Double-Blind Phase and received at least 1 dose of study drug.||percentage of participants|||Number
36663|NCT01497756|Secondary|Side Effects|Any recorded complications|Eight months|All patients||participants|||Number
36664|NCT01497756|Primary|Usage|Number of patients on whom CAPP is used|Eight months|Entire number of participants||participants|||Number
36665|NCT01497665|Secondary|Six Month Overall Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further survival data was collected and there was insufficient number of participants with data collected for this outcome measure.|||||
36666|NCT01497665|Secondary|Duration of Overall Progression Free Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further efficacy data was collected and there was insufficient number of participants with data collected for this outcome measure.|||||
36667|NCT01497665|Secondary|Duration of Overall Objective Response||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further data on response was collected and there was insufficient number of participants with data collected for this outcome measure.|||||
36669|NCT01497665|Primary|Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis|Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), < 30% decrease but <20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), >= 20% (>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.|upon enrollment through end of study period (1 year after last patient is enrolled)|||participants|||Number
36670|NCT01497366|Secondary|Percentage of Participants With Viral Relapse Following Treatment|Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.|Up to Post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
36671|NCT01497366|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either~Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement~Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)"|Baseline up to Week 24|Full Analysis Set||percentage of participants|||Number
36672|NCT01497366|Secondary|Change From Baseline in HCV RNA||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
36673|NCT01497366|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 Weeks|Participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
36674|NCT01497366|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)|SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.|Post-treatment Week 24|Full Analysis Set||percentage of participants|||Number
36675|NCT01497366|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities||Up to 24 weeks plus 30 days following the last dose of study drug|Safety Analysis Set||participants|||Number
36676|NCT01497366|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.|Post-treatment Week 12|Full Analysis Set||percentage of participants|||Number
36677|NCT01497275|Secondary|Overall Survival at 5 Year|Number of participants who were alive at the 5 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|5 year|No analysis completed due to study being terminated prior to the 5 year time point.|||||
36678|NCT01497275|Secondary|Overall Survival at 1 Year|Number of participants who were alive at the 1 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|1 year|1 subject did not reach the one year evaluation because the study was terminated.||participants|||Number
36679|NCT01497275|Secondary|Number of Participants With Progression Free Survival|Progression-free survival will be defined as time from on-study to disease progression or death, whichever comes first|6 months|Only 3 subjects provided evaluable data at the 6 month time point. 2 subjects did not reach this time-point so they were not assessed for progression||participants|||Number
36680|NCT01497275|Primary|Response Rate (Complete Response + Partial Response)|"Disease will be assessed every 3 months.~The Cheson criteria will be used to define response:~Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy.~Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features: a) they should be clearly measurable in at least two perpendicular measurements; b) they should be from as disparate regions of the body as possible; and c) they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved."|3 months|Only 3 subjects completed the drug regimen; 1 subject did not complete due to disease progression; 1 did not complete due to adverse event.||participants|||Number
36681|NCT01497262|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity|28 weeks|Safety set includes all patients who received at least one dose of study drug||Participants|||Number
36682|NCT01497262|Secondary|Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.|The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.|4 months|Safety set includes all patients who received at least one dose of study drug||Percent of Participants|||Number
36683|NCT01497197|Secondary|Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to 15-20 days post r-hCG administration|Safety population included all randomized subjects who received at least one dose of the trial treatment.||subjects|||Number
36788|NCT01495858|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
36684|NCT01497197|Secondary|Number of Subjects With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35–42.|35 to 42 days post r-hCG administration|MITT included all subjects randomized into trial who received at least 1 dose of Gonal-f® or Luveris®, and completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). ‘N’=signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.||subjects|||Number
36685|NCT01497197|Secondary|Number of Subjects With Biochemical Pregnancies|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.|35 to 42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||subjects|||Number
36686|NCT01497197|Secondary|Cycle Cancellation Rate Prior to r-hCG|If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.|Up to 85 days|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||percentage of subjects|||Number
36687|NCT01497197|Secondary|Total Pregnancy Rate and Clinical Pregnancy Rate|The subject was considered to have a positive pregnancy result if beta-hCG >10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15–20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35–42.|35-42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||percentage of subjects|||Number
36688|NCT01497197|Secondary|Number of Fetal Sacs With Detectable Heart Beats|Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.||Fetal sacs||Standard Deviation|Mean
36689|NCT01497197|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35–42 post r-hCG to confirm clinical pregnancy.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.||Fetal sacs||Standard Deviation|Mean
36690|NCT01497197|Secondary|Implantation Rate|The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.||fetal sacs/embryo transferred||Standard Deviation|Mean
36691|NCT01497197|Secondary|Total Number of Stimulation Treatment Days|The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.|6 days post stimulation (Number of stimulation days+6 days)|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).||days||Standard Deviation|Mean
36692|NCT01497197|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)|Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.|Screening|Data was not analysed as per planned analysis due to frequent protocol violations/deviations, there was no subject eligible to be analyzed per protocol.|||||
36693|NCT01497197|Primary|Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation|Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.|34-38 hours post r-hCG administration|Modified intention-to-treat (MITT) included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following recombinant human follicle stimulating hormone (r-hFSH) stimulation and r-hCG injection).||oocytes||Standard Deviation|Mean
36694|NCT01497171|Primary|Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.|Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.|12 months|No analysis was done due to early termination of the study.|||||
36695|NCT01496469|Secondary|Change From Baseline in Serum Urate Levels at Week 6||Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
36696|NCT01496469|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean DBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
36697|NCT01496469|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
36698|NCT01496456|Secondary|Lesion Survival After 3 Years|Discrete time survival analysis of time to first lesion progression.|3 years|Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased.||Lesions|Participants||Number
36699|NCT01496456|Secondary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories|Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).|Baseline through 3 years|||Lesions|Participants||Number
36700|NCT01496456|Primary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)|Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).|Baseline through 3 years|Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).||Lesions|Participants||Number
36701|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT|The change between the AUC for glucagon at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||ng*hours/L||Standard Error|Least Squares Mean
36702|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT|The change between the AUC for insulin/glucose ratio at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||pmol*hr/mmol||Standard Error|Least Squares Mean
36703|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT|The change between the AUC for C-peptide at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||nmol*hours/L||Standard Error|Least Squares Mean
36704|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT|The change between the AUC for insulin at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||pmol*hours/L||Standard Error|Least Squares Mean
36705|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT|The change between the AUC for glucose at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mmol*hours/L||Standard Error|Least Squares Mean
36706|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)|The change between the glucose value collected at weeks 6 and 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mmol/L||Standard Error|Least Squares Mean
36707|NCT01496430|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
36708|NCT01496430|Secondary|Change From Baseline in HbA1c|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
36709|NCT01496430|Secondary|Time to First Glycemic Rescue|The time to the first instance of participants requiring glycemic rescue during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.||Days||Inter-Quartile Range|Median
36710|NCT01496430|Secondary|Percentage of Participants Requiring Rescue Glycemic Therapy|Percentage of participants requiring rescue glycemic therapy during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.||percentage of participants|||Number
36711|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36712|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36713|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36714|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36715|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36716|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36717|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36718|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean systolic blood pressure measured week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36719|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36720|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.||mm Hg||Standard Error|Least Squares Mean
36721|NCT01496430|Secondary|Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
36722|NCT01496430|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
36723|NCT01496430|Primary|Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
36724|NCT01496352|Secondary|Incidence of Surgical Site Infection|The incidence of probable or definite surgical site infection as determined by the Investigator.|Up to 30 Days After Surgery|As treated||Participants|||Number
36725|NCT01496352|Secondary|Antibiotic Resistance|Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery|Baseline up to Day 5|As Treated||Participants|||Number
36726|NCT01496352|Secondary|Renal Function|Changes in serum creatinine from surgery on Day 1 until 14 days after surgery|Baseline up to Day 14|As treated||Participants|||Number
36727|NCT01496352|Secondary|Maximal Plasma Concentration (Cmax)|Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48, 96 hours post-dose|All subjects receiving DFA-02 active gel||mcg/mL||Standard Deviation|Mean
36728|NCT01496352|Primary|Area Under Curve (AUC)|Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48 96 hours post-dose|All Subjects Receiving Active Drug||mcg/h/mL||Standard Deviation|Mean
36729|NCT01496352|Primary|Number of Patients With Adverse Events, Laboratory, Physical Examination Changes|Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.|Baseline up to Day 30|As Treated||Participants|||Number
36730|NCT01496313|Secondary|Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.||Week 3 to week 60 (maximum)|All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.||ng/ml||Standard Deviation|Mean
36731|NCT01496313|Secondary|Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||% change||Standard Deviation|Mean
36732|NCT01496313|Secondary|Time to Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||Months||95% Confidence Interval|Median
36733|NCT01496313|Secondary|Duration of Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||Months||95% Confidence Interval|Median
36734|NCT01496313|Secondary|Best Objective Response||Randomisation to week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD||Participants|||Number
36735|NCT01496313|Primary|Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator|ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1|Randomisation to week 60 (maximum)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR||Proportion of participants||95% Confidence Interval|Number
36736|NCT01496287|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post procedure|Only 62 of the initial 70 subjects achieved procedure success, and were present for 2 week follow-up assessment with Tula tube in situ, such that tube retention could be measured.||ears|Participants||Number
36737|NCT01496287|Secondary|Procedure Tolerability|"Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient’s score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.~Tolerability was defined as an average post-procedure pain score (of treated ears) <= 3"|Day 0 (day of procedure)|||participants|||Number
36738|NCT01496287|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)|||participants|||Number
36739|NCT01496287|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)|Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted.||devices|Participants||Number
36740|NCT01496287|Primary|Number of Participants With Procedural, Serious, and Device-Related Adverse Events|Adverse events which are procedural, serious, and device-related.|procedure up to 2 weeks post procedure|||participants|||Number
36742|NCT01496274|Secondary|Investigator’s (or Surgeon’s) Overall Clinical Assessment of Hemostatic Efficacy for Surgical Prophylaxis, Based on a Four Point Ordinal Scale (Excellent, Good, Moderate, Poor/No Response)|Number of surgical events treated prophylactically with rIX-FP that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s (surgeon’s) overall assessment of hemostatic efficacy for surgical prophylaxis.|Up to 14 days after surgery|Surgical Population||events|Participants||Number
36743|NCT01496274|Secondary|Clearance of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||mL/hr||Standard Deviation|Mean
36744|NCT01496274|Secondary|Area Under the Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUClast) of a single dose of rIX-FP. PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||IU*hr/dL||Standard Deviation|Mean
36745|NCT01496274|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||hour||Standard Deviation|Mean
36746|NCT01496274|Secondary|Incremental Recovery of rIX-FP|Pharmacokinetic (PK) data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.||(IU/dL)/(IU/kg)||Standard Deviation|Mean
36747|NCT01496274|Secondary|rIX-FP Consumed Per Month While Maintaining Assigned Prophylactic Treatment Interval During Routine Prophylaxis.|Time frame: For Prophylaxis Arm 7-, 10- and 14-day regimens, median 269, 240 and 386 days respectively. For On-demand Arm, prophylaxis regimen, median 316 days.|Median 269, 240, 386 and 316 days, respectively (see Description)|Efficacy Population||IU/kg/month||Standard Deviation|Mean
36748|NCT01496274|Secondary|Investigator’s Overall Clinical Assessment of Hemostatic Efficacy for Treatment of Bleeding Episodes, Based on a Four Point Ordinal Scales (Excellent, Good, Moderate, Poor/No Response)|Number of bleeding episodes requiring treatment that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s clinical assessment of hemostatic efficacy, expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months|Efficacy Population||percentage of bleeding episodes|Participants||Number
36749|NCT01496274|Secondary|Proportion of Bleeding Episodes Requiring One or ≤ Two Injections of rIX-FP to Achieve Hemostasis|Number of injections required to achieve hemostasis expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months.|Efficacy Population||percentage of bleeding episodes treated|Participants||Number
36750|NCT01496274|Secondary|Number of Subjects Developing Antibodies Against rIX-FP||For the duration of the study; median 20.27 months.|Safety Population||participants|||Number
36751|NCT01496274|Secondary|The Frequency of Related Adverse Events|The percentage of participants experiencing treatment-related adverse-events (TEAEs).|For the duration of the study; median 20.27 months.|Safety Population||Percentage of participants|||Number
36752|NCT01496274|Primary|Number of Subjects Developing Inhibitors Against Factor IX (FIX)|The number of participants developing inhibitors against factor IX (FIX) along with the 95% Clopper-Pearson confidence interval, are summarized for subjects with 50 or more exposure days (EDs) to rIX-FP, and for all participants in the study.|Up to 27.7 months (maximum)|Safety Population||participants||95% Confidence Interval|Number
36753|NCT01496274|Primary|Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized)|Subjects in the on-demand arm received on-demand dosing with rIX-FP for up to 26 weeks (on-demand regimen), and then received weekly prophylaxis with rIX-FP for the remainder of the study (prophylaxis regimen). The effectiveness of prophylaxis in comparison to on-demand therapy was investigated by comparing the same subject’s annualized spontaneous bleeding rate (AsBR) during the on-demand regimen and during the prophylaxis regimen.|Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.|This analysis includes only the participants assigned to the on-demand arm who received at least 1 dose of rIX-FP in the on-demand regimen and at least 1 dose of rIX-FP in the prophylaxis regimen.||bleeds/year/subject||Inter-Quartile Range|Median
36754|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|8 weeks|||units on a scale||Standard Deviation|Mean
36755|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|Baseline|||units on a scale||Standard Deviation|Mean
36756|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|8 weeks|||units on a scale||Standard Deviation|Mean
36757|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|Baseline|||units on a scale||Standard Deviation|Mean
36758|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|8 weeks|||units on a scale||Standard Deviation|Mean
36759|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|Baseline|||units on a scale||Standard Deviation|Mean
36760|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|8 weeks|||units on a scale||Standard Deviation|Mean
36761|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|Baseline|||units on a scale||Standard Deviation|Mean
36762|NCT01496183|Secondary|Change From Baseline in Palatability of Meal Using a Visual Analog Scale||Assessed at different time points: 1 week and 2 weeks||||||
36763|NCT01496183|Secondary|Change From Baseline in Appetite Sensations Using a Visual Analog Scale||Assessed at different time points: 1 week and 2 weeks||||||
36764|NCT01496183|Secondary|Physical Activity|motion monitor samples body movements|2 weeks||||||
36765|NCT01496183|Secondary|Change From Baseline in Insulin||Assessed at different time points: 1 week and 2 weeks||||||
36766|NCT01496183|Secondary|Change From Baseline in Leptin||Assessed at different time points: 1 week and 2 weeks||||||
36767|NCT01496183|Secondary|Change From Baseline in Glucose||Assessed at different time points: 1 week and 2 weeks||||||
36768|NCT01496183|Secondary|Change From Baseline in Ghrelin||Assessed at different time points: 1 week and 2 weeks||||||
36769|NCT01496183|Secondary|Change From Baseline in Lipid Profile||Assessed at different time points: 1 week and 2 weeks||||||
36770|NCT01496183|Secondary|Change From Baseline in Resting Metabolic Rate||2 weeks||||||
36771|NCT01496183|Secondary|Change From Baseline in 24-Hour Dietary Recall||Assessed at different time points: 1 week and 2 weeks||||||
36772|NCT01496183|Secondary|Change From Baseline in Body Composition|percent of fat vs. fat-free -or lean mass|2 weeks||||||
36773|NCT01496183|Primary|Change From Baseline in Weight||Assessed at baseline and 2 weeks|||Kg||Standard Deviation|Mean
36774|NCT01495975|Secondary|Unplanned Readmission or ED Visit|Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.|1 month after discharge||||||
36775|NCT01495975|Secondary|Diabetes Self-Management||1 month from discharge||||||
36776|NCT01495975|Secondary|Diabetes Distress|Measured by the Problem Areas in Diabetes (PAID) Questionnaire|1 month from discharge||||||
36777|NCT01495975|Primary|Glycemic Control|Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge|1 month from discharge|||mg/dL||Standard Deviation|Mean
36778|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2||Baseline and day 2|Safety Population||Breaths/min||Standard Deviation|Mean
36779|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2||Baseline and day 2|Safety Population||Beats/min||Standard Deviation|Mean
36780|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2||Baseline and Day 2|Safety Population||mmHg||Standard Deviation|Mean
36781|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2||Baseline and day 2|Safety Population||mmHg||Standard Deviation|Mean
36782|NCT01495858|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36783|NCT01495858|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population||participants|||Number
36784|NCT01495858|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
36785|NCT01495858|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
36786|NCT01495858|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
36787|NCT01495858|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
36791|NCT01495858|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36792|NCT01495858|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36793|NCT01495858|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36794|NCT01495858|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36795|NCT01495858|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36796|NCT01495858|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36797|NCT01495858|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36798|NCT01495858|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
36799|NCT01495858|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
36800|NCT01495858|Secondary|Total Sleep Time Measured by Actigraphy|Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
36801|NCT01495858|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
36802|NCT01495858|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
36803|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
36804|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
36876|NCT01494610|Secondary|Mean of Maximum Heart Rate Over 0 to 4 Hours Post Dose for Salmeterol|The maximum observed value of heart rate was measured from the time of the morning dose on Day 10 to 4 hours post dose.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||bpm||Standard Deviation|Mean
47726|NCT01350245|Primary|Probability of Overall Survival at 15 Months Post-treatment|Probability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant.|15 months|||percentage of probability|||Number
36805|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
36806|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L (Liter)||95% Confidence Interval|Least Squares Mean
36807|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
36808|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
36809|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
36810|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.||L/h (liter per hour)||95% Confidence Interval|Least Squares Mean
36811|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
36812|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
36813|NCT01495702|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set||percentage of participants|||Number
36814|NCT01495702|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: participants were randomized, received at least 1 dose of study drug, had no documented resistance, and were on an NNRTI at screening||percentage of participants|||Number
36815|NCT01495585|Secondary|ALT Levels||7 months|||U/L||Standard Deviation|Mean
36816|NCT01495585|Primary|Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.||28 days|||log(IU/ml)||Standard Deviation|Mean
36818|NCT01495572|Primary|Clinical Tumor Response|Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|One year|||participants|||Number
36819|NCT01495286|Secondary|Skin Assessment|Areas of skin where the Stim Care electrodes are placed will be assessed for redness, tenderness, or any other change in skin condition. Assessment will take place at baseline, after the NESAP procedure, upon discharge from the hospital, and after one week. If there is a problem at one week, there will be additional follow-up at two weeks.|Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants,we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one sided paired t test||participants|||Number
36820|NCT01495286|Secondary|Pain During TENS Treatment and Routine Heel Stick|Pain scores were measured using the Premature Infant Pain Profile (PIPP). The PIPP is a composite pain tool that measures pain based on behavioral and physiologic parameters and adjusts for gestational age. Differences in pain scores were recorded throughout the heel stick process, using a baseline score as reference. Mean pain scores were calculated before NESAP (baseline), after the TENS unit was turned on, after ten minutes of NESAP but before heel stick, during heel cleaning, during the initial heel stick, during heel squeeze, and during recovery. For term infants, the range of PIPP scores is on a scale of 0 for no pain to 18 for severe pain. A score of 6 indicate mild pain, and a score of 11 -12 indicates moderate pain. An increase in PIPP score of 4 or greater from baseline indicates a significant change in pain level.|Pain score given during the heel stick process and for 2 minutes afterwards|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.||units on a scale||Standard Deviation|Mean
36821|NCT01495286|Secondary|Blood Pressure During TENS Treatment and Heel Stick|Changes in systolic and diastolic blood pressure after initial baseline. Measurements will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.||mm Hg||Standard Deviation|Mean
36822|NCT01495286|Primary|Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick|Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.|Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant increase in pain level. With 30 infants, we had 90% power to detect a significant increase in PIPP score with a .05 level, one-sided paired t-test.||percentage of oxygen saturation||Standard Deviation|Mean
36823|NCT01495286|Primary|Heart Rate During Treatment With TENS Unit|Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.||beats per minute||Standard Deviation|Mean
36824|NCT01495000|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6|The number of participants with positive and negative results for both neutralizing antibodies to denosumab and for binding antibodies to denosumab at Month 6 are summarized.|Month 6|ITT Population. Only participants available at the specified time point were analyzed.||participants|||Number
36825|NCT01495000|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Blood samples were collected for the measurement of red cell distribution width values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||percentage||Standard Deviation|Mean
36826|NCT01495000|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Blood samples were collected for the measurement of red blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
36827|NCT01495000|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Blood samples were collected for the measurement of mean corpuscular volume values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||femtoliters||Standard Deviation|Mean
36828|NCT01495000|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Blood samples were collected for the measurement of hemoglobin values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||picograms||Standard Deviation|Mean
36829|NCT01495000|Secondary|Change From Baseline in Hematocrit at Month 6|Blood samples were collected for the measurement of hematocrit values. Change from Baseline was calculated as the Month 6 value minuse the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||proportion of RBCs in blood||Standard Deviation|Mean
36830|NCT01495000|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Blood samples were collected for the measurement of calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglyceride, urea/BUN, and VLDL cholesterol calculation values. Change from Baseline was calcualted as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||millimoles per liter (MMOL/L)||Standard Deviation|Mean
36831|NCT01495000|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||micromoles per liter (UMOL/L)||Standard Deviation|Mean
36832|NCT01495000|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6|Blood samples were collected for the measurement of basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil, total neutrophil, platelet count, and white blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
36833|NCT01495000|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6|Blood samples were collected for the measurement of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatinine kinase, gamma glutamyl transferase, and lactate dehydrogenase values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
36834|NCT01495000|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6|Blood samples were collected for the measurement of albumin, hemoglobin, mean corpuscle hemoglobin concentration, and total protein values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||grams per liter (g/L)||Standard Deviation|Mean
36835|NCT01495000|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Blood samples were collected for the measurement of albumin/globulin ratio and BUN/creatinine ratio values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.||ratio||Standard Deviation|Mean
36836|NCT01495000|Secondary|Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6|The number of participants with laboratory parameter values of potential clinical concern at Month 6 are summarized. The following are the laboratory values of potential clinical concern: alkaline phosphatase, High: >375 units/Liter (L); aspartate aminotransferase, High: >165 units/L; creatinine, High: >159 micromoles (µmol)/L; glucose, Low: <3 millimoles (mmol)/L; hematocrit, Low: <0.325; hemoglobin, Low: <91grams/L; phosphorus, High: >1.723 mmol/L; potassium, High: >6.3 mmol/L; sodium, Low: <130 mmol/L; total neutrophils, Low: <0.9 10^9 cells (GI)/L; blood urea nitrogen (BUN), High: >21mmol/L; uric acid, High: 654 µmol/L.|Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||participants|||Number
36837|NCT01495000|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6|"Vital sign values of potential clinical concern were defined as: change in heart rate >30 beats per minutes (bpm), change in systolic blood pressure (SBP) >30 millimeters of mercury (mmHg), and change in diastolic blood pressure (DBP) >20 mmHg. The number of participants with post-Baseline vital sign values of potential clinical concern who did not have values of potential clinical concern at Baseline are summarized. If the change from Baseline is a decrease greater than the threshold, it is categorized as “low.” If the change from Baseline is an increase greater than the threshold, it is categorized ad “high."|Baseline; Months 1, 3, and 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.||participants|||Number
36838|NCT01495000|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|ITT Population: all participants who received one dose of study medication||participants|||Number
36839|NCT01495000|Secondary|Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6|Blood samples were collected for the measurement of s-CTx and s-PINP, which are used as biomarkers of bone resorption and formation, respectively. The median percent change from Baseline in s-CTX and s-PINP markers at Months 1, 3, and 6 was calculated as: (post-Baseline value minus Baseline value) * 100 / Baseline value.|Baseline; Months 1, 3, and 6|ITTE Population. Only participants with s-CTX and s-PINP values at both Baseline and Months 1, 3, and 6 were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITTE Population.||percent change||Inter-Quartile Range|Median
36840|NCT01495000|Secondary|Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6|BMD at the total hip, femoral neck, and trochanter was measured by the DXA scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate).|Baseline and Month 6|ITTE Population. Only participants with BMD values at both Baseline and Month 6 were analyzed.||percent change||Standard Error|Least Squares Mean
36841|NCT01495000|Primary|Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6|Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all randomized participants who received one dose of study medication, and who had a Baseline measure and at least one post-Baseline efficacy measure during the Double-blind Treatment Phase. Only participants with BMD values at both Baseline and Month 6 were analyzed.||percent change||Standard Error|Least Squares Mean
36842|NCT01494987|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
36843|NCT01494987|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
36844|NCT01494987|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations, analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
36845|NCT01494987|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.||percent of HbA1c in blood||Standard Deviation|Mean
36846|NCT01494818|Secondary|Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||micrograms||Standard Deviation|Mean
36847|NCT01494818|Secondary|Median Front Lens Deposits|Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Units on a scale||Full Range|Median
36848|NCT01494818|Secondary|Protective Index|A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Percent of visible contact lens surface||Standard Deviation|Mean
36849|NCT01494818|Primary|Change From Baseline in Upper Eyelid Margin Staining at Month 3|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||square millimeters||Standard Deviation|Mean
36850|NCT01494818|Primary|Upper Lid Redness|The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Percentage of total surface measured||Standard Deviation|Mean
36902|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||Femtoliters (FL)||Standard Deviation|Mean
36851|NCT01494818|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Seconds||Standard Deviation|Mean
36852|NCT01494818|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Units on a scale||Full Range|Median
36853|NCT01494818|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol||Units on a scale||Full Range|Median
36854|NCT01494753|Primary|Mean Intra Ocular Pressure (IOP) at 8.00am|Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.|Day 42 and Day 84 (8.00am for the IOP)|Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment.||mmHg||Standard Deviation|Mean
36855|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
36856|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
36857|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.|Baseline and immediately after treatment administration|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
36858|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
36859|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
36985|NCT01494298|Secondary|LDL Density in African American Males With Diabetes and Those Without Diabetes|"LDL size subclassification was divided into the following groups (from largest size to smallest size): LDL I, LDL IIa, LDL IIb, LDL IIIa, LDL IIIb, LDL IVa, LDL IVa, and LDL IVb.~For differences posted P<0.05 for LDL I, LDL IIb, LDL IIIa, and LDL IIIa +b"|at entry|||percentage of total LDL particles||Standard Error|Least Squares Mean
36860|NCT01494649|Primary|Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.|Baseline and immediately after treatment administration|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.||units on a scale||95% Confidence Interval|Mean
36861|NCT01494610|Secondary|Number of Participants With an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization (Day 1) up to Follow-up (Days 47-50)|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
36862|NCT01494610|Secondary|Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)|"Blood samples of participants were collected for the evaluation of calcium, chloride, glucose, potassium, sodium, carbon dioxide (CO2) content/bicarbonate, and urea/BUN. All of these parameters are measured to help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||µmol/L||Standard Deviation|Mean
36863|NCT01494610|Secondary|Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid|"Blood samples of participants were collected for the evaluation of DP, TB, creatinine, and uric acid. DB and TB are measures that help assess the condition of the liver, and creatinine and uric acid are measures that help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
36864|NCT01494610|Secondary|Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)|"Blood samples of participants were collected for the evaluation of AP, ALT, AST, and GGT. All of these parameters are measured to help assess the condition of the liver. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
36865|NCT01494610|Secondary|Mean Albumin and Total Protein|"The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||g/L||Standard Deviation|Mean
36866|NCT01494610|Secondary|Mean Hematocrit|"Blood samples of participants were collected for the evaluation of hematocrit. The hematocrit is the percentage of the RBCs in the blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||percentage of RBCs||Standard Deviation|Mean
36867|NCT01494610|Secondary|Mean Corpuscle Volume (MCV)|"Blood samples of participants were collected for the evaluation of MCV. MCV is a measure of the average red blood cell size that is reported as part of a standard complete blood count. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Femtoliters (fL; 10^-15 L)/cell||Standard Deviation|Mean
36903|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||Picograms (PG) per cell (PG/cell)||Standard Deviation|Mean
36868|NCT01494610|Secondary|Mean Corpuscule Hemoglobin (MCH)|"Blood samples of participants were collected for the evaluation of MCH. MCH is the average mass or amount of hemoglobin per red blood cell in a sample of blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subject Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||picograms (pg)/cell||Standard Deviation|Mean
36869|NCT01494610|Secondary|Red Blood Cell (RBC) Count and Reticulocytes|"Blood samples of participants were collected for the evaluation of RBC and reticulocytes count. Reticulocytes are immature red blood cells. Normally, about 1% to 2% of the red blood cells in the blood are reticulocytes. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Trillion (10^12) cells/L||Standard Deviation|Mean
36870|NCT01494610|Secondary|Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration|"Blood samples of participants were collected for the evaluation of mean hemoglobin (mean level of hemoglobin in the whole blood sample) and MCH concentration. The MCH concentration is the average concentration of hemoglobin in a red blood cell. Hemoglobin is the red pigment in the blood, and it is reponsible for carrying oxygen. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
36871|NCT01494610|Secondary|Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count|"Blood samples of participants were collected for the evaluation of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and WBC count. Data are reported for the first (1st) and second (2nd) administration (admin) of FP/salmeterol via MDPI or capsule-based inhaler. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population: all participants who received at least one dose of study medication. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.||Giga (10^9) cells/L||Standard Deviation|Mean
36872|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the maximum plasma glucose level. Weighted mean was calculated by using all values of plasma glucose at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||mmol/L||Standard Deviation|Mean
36873|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the minimum plasma potassium level. Weighted mean was calculated by using all values of plasma potassium at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Only those participants contributing data at the indicated time points were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
36874|NCT01494610|Secondary|Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett’s Formula (QTc[B]) and the QT Interval Corrected According to Fridericia’s Formula (QTc[F])|The electrocardiogram (ECG) of the participants was taken, and the maximum and weighted mean of QTc(B) and QTc(F) was measured. Weighted mean was calculated by using all values of QTc(B) and QTc(F) at the indicated timepoint contributing to the calculation of the mean but with different weightage. The ECG helps in the assessment of the condition of the heart. The QT interval gives the measure of the heart rate, and the cQT interval gives the corrected value.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 3 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||Milliseconds (msec)||Standard Deviation|Mean
36875|NCT01494610|Secondary|Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose|The diastolic and systolic blood pressure of the participants was measured. The maximum and minimum observed values from the time of the morning dose on Day 10 to 4 hours post dose were measured for SBP and DBP. The weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. Weighted mean was calculated by using all values of DBP and SBP at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||millimeters of mercury (mmHg)||Standard Deviation|Mean
36986|NCT01494298|Primary|ApoB Levels in African American Men With Diabetes and Those Without.|Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.|At study entry|||mg/dL||Standard Error|Least Squares Mean
36877|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Heart Rate for Salmeterol|The heart rate (number of heartbeats per unit of time, typically expressed as beats per minute [bpm]) of the participants was monitored for evaluating the weighted mean over the course of 0 to 4 hours post dose. The Capsule-MDPI difference for heart rate was calculated for each participant, and the weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. The weighted mean was calculated by using all values at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||bpm||Standard Deviation|Mean
36878|NCT01494610|Secondary|Serum Cortisol Minimum (Cmin) for FP|Blood samples of participants were collected for the evaluation of minimum serum cortisol. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in serum cortisol concentrations.|Day 10 of each study period (Periods 1-4); Study Day 10 (+/-1) (reference day is Study Day 1 or Randomization day), Period 1; Study Day 20 (+/-1), Period 2; Study Day 30 (+/-1), Period 3; Study Day 40 (+/-1), Period 4|PK/PD Population||nmol/L||95% Confidence Interval|Geometric Mean
36879|NCT01494610|Secondary|Mean Urine Cortisol Excretion Over 0 to 24 Hours Post Dose for FP|Urine samples of participants were collected to evaluate urine cortisol excretion over 0-24 hours post treatment dose. A 24-hour urine cortisol sample was used to measure the total amount of cortisol excreted in urine in 24 hours. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in the amount of cortisol excreted in the urine.|0-24 hours post dose on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||nmol||95% Confidence Interval|Geometric Mean
36880|NCT01494610|Secondary|Tmax for Salmeterol|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||hours||Full Range|Median
36881|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for Salmeterol|Blood samples of participants were collected for evaluating t1/2. t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.||hours||95% Confidence Interval|Geometric Mean
36882|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of Salmeterol in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||pg/mL||95% Confidence Interval|Geometric Mean
36883|NCT01494610|Secondary|Time of Occurrence of Cmax (Tmax) for FP|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||hours||Full Range|Median
36884|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for FP|Blood samples of participants were collected for evaluating t1/2. The t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.||hours||95% Confidence Interval|Geometric Mean
36885|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of FP in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum, respectively.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||Picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
36886|NCT01494610|Secondary|Mean AUC(0-tlast) for FP|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tlast). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||pg*h/mL||95% Confidence Interval|Geometric Mean
36887|NCT01494610|Secondary|Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tau) and AUC(0-tlast). AUC(0-tau) is a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||pg*h/mL||95% Confidence Interval|Geometric Mean
36888|NCT01494610|Primary|Weighted Mean Serum Cortisol (SC) Over 0 to 12 Hours Post Dose|Participants' blood samples were collected and analyzed for SC levels. Weighted mean SC levels are evaluted as a measure of the degree of cortisol suppression, allowing for the determination of whether differences in systemic exposure to the inhaled steroid component of two devices can be significant enough to result in the differences in the body’s ability to release cortisol. Weighted means were derived by calculating the AUC over the 0-12 hour period, using the linear trapezoidal rule (statistical technique used for numerical analysis) and then dividing it by the actual time interval.|At pre-morning dose; 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population||Nanomoles per liter (nmol/L)||95% Confidence Interval|Geometric Mean
36889|NCT01494610|Primary|Mean Area Under the Concentration Time Curve Over the Dosing Period (AUC[0-tau]) for FP|Blood samples of participants (par.) with asthma and chronic obstructive pulmonary disease (COPD) were collected and analyzed for AUC(0-tau), a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to difficulty in breathing. COPD is a chronic lung disease with structural changes in lungs, leading to difficulty in breathing.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Pharmacokinetic/pharmacodynamic (PK/PD) Population: all participants who received at least one dose of study medication, except for one who was identified as a full protocol violator. Participants with at least one non-missing value in the replicate observations were included.||Picogram hours per milliliter (pg*h/mL)||95% Confidence Interval|Geometric Mean
36890|NCT01494584|Secondary|Number of Participants With the Indicated Neurological Abnormality|Abnormal Central Nervous System (CNS) symptoms were assessed by a full and brief neurological examination. A full neurological examination included assessment of mental status, cranial nerves, gait, coordination, sensation, speech/language, muscle strength, muscle tone, and reflexes. A brief neurological examination included assessment of mental status, cranial nerves, gait, coordination, reflexes, and speech/language. Neurological parameters assessed were memory impairment, impaired intellect, decreased attention, psychomotor slowing, decreased muscle strength, hpertonia, somnolence, right and left bicpes, right and left brachioradialis, right and left knee, right and left ankle, and right and left planter response. Neurological examination was performed at Day 7 of Titration 3 (600 mg/day).|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population||Participants|||Number
36891|NCT01494584|Secondary|Change From Baseline in Post Void Residual Ultrasound at Day 21|A post void residual (PVR) bladder ultrasound was carried out as a measure of bladder function. PVR was clinically indicated following the occurrence of adverse events relating to the lower urinary tract (e.g., micturition difficulties, including urinary hesitancy or urinary retention). These assessments were also repeated following drug withdrawal following such events. A prompt follow-up PVR was recommended if a high score was obtained from a participant on the Pediatric Lower Urinary Tract Symptom scale (the PLUTS scale is a clinician-rated scale used to assess lower urinary tract symptoms, including urinary retention) and if the clinician felt that the participant was at risk or had symptoms of urinary retention. PVR was measured at Day 7 of Titration 3 (600 mg/day). Baseline is defined as the Screening visit.|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population||ML||Standard Deviation|Mean
36892|NCT01494584|Secondary|Change From Baseline in Heart Rate (HR)|Vital sign assessment included heart rate measurement and was assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.||Beats per Minute (BPM)||Standard Deviation|Mean
36893|NCT01494584|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Vital sign assessment included the measurement of systolic and diastolic blood pressure at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), Day 7 pre-dose, and 3 h post dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): Day 21 pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): Day 35 pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
36904|NCT01494584|Secondary|Change From Baseline in Hematocrit at Day 7 Post Each Up-titration|"Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. The International System of Units (SI) Fraction of one unit (1) is reported here."|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||Fraction of one unit (1)||Standard Deviation|Mean
36894|NCT01494584|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate (QTc intervals) was used. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). ECG parameters were assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose, and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. The number of participants with abnormal (Abn) clinically significant (CS) and not clinically significant (NCS) ECG findings was recorded. The investigator determined if an ECG finding was CS or NCS.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Participants|||Number
36895|NCT01494584|Secondary|Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma t1/2. Steady-state t1/2 is derived as (Vd/F) / (CL/F), where Vd/F is defined as the apparent volume of distribution after extravascular (e.g., oral) administration, and CL/F is defined as the apparent clearance following oral dosing.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population. Only those participants available at the indicated time point were analyzed.||Hours||95% Confidence Interval|Geometric Mean
36896|NCT01494584|Secondary|Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma Tmax.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population||Hours||Full Range|Median
36897|NCT01494584|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine|Ctau refers to the pre-dose (trough) concentration at the end of the dosing interval which is equivalent to the minimum observed concetration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the Ctau for n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population||ng/mL||95% Confidence Interval|Geometric Mean
36898|NCT01494584|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine|The area under the curve was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the plasma n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population||h*ng/mL||95% Confidence Interval|Geometric Mean
36899|NCT01494584|Secondary|Percent Change From Baseline in 28-day Seizure Frequency Rate|Participants or their caregivers recorded the number of seizures experienced by the participant, by seizure type (e.g., simple partial seizure [seizure that affects only a small region of the brain; consciousness is unaffected], complex partial seizure [seizure associated with unilateral cerebral hemisphere involvement and causing impairment of awareness or responsiveness], etc.), as well as by duration of episodes of innumerable seizure activity, in their daily diaries during all phases of this study. Percent change from baseline is defined as 100 * (rate in a given period minus the baseline rate) / (baseline rate). baseline seizures are defined as those seizures that occurred after Screening and before the start of the treatment. Post-baseline seizures are defined as those seizures that occurred from the start of the treatment until the start of Follow-up. Seizure frequency rate was computed as: 28 * (number of seizures during given period / number of days in given period).|Baseline (Screening) and until Follow-up or early discontinuation (assessed up to 46 days)|All Subjects Population. Only participants with baseline and post-baseline seizure measurements were included in the analysis.||Percent change||Standard Deviation|Mean
36900|NCT01494584|Secondary|Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up|Urinalysis parameters analyzed included: urine occult blood (UOB), urine glucose (UG), urine ketones (UK), and urine protein (UP). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test provides results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, and 80, indicating proportional concentrations in the urine sample. Urinalysis parameters were assessed at Titration 1 (T1; 300 mg/day), Titration 2 (T2; 450 mg/day), Titration 3 (T3; 600 mg/day), Titration 4 (T4; 750 mg/day), and Titration 5 (T5; 900 mg/day).|Screening, Day 1 (D1), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), Day 35 (D35), and at the Follow-up Visit (up to Day 46)|All Subjects Population (ASP). Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points and for different parameters, so the overall number of participants analyzed reflects everyone in the ASP.||Participants|||Number
36901|NCT01494584|Secondary|Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.||10^12 cells/L (TI/L)||Standard Deviation|Mean
36914|NCT01494584|Primary|Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine|Clearance (CL/F) is defined as dose/AUC(0-tau). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate CL/F.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population||Liters/Hour||95% Confidence Interval|Geometric Mean
36905|NCT01494584|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (G/L)||Standard Deviation|Mean
36906|NCT01494584|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Giga (10^9) cells per liter (GI/L)||Standard Deviation|Mean
36907|NCT01494584|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
36908|NCT01494584|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
36909|NCT01494584|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International Units per Liter (IU/L)||Standard Deviation|Mean
36910|NCT01494584|Secondary|Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per Liter (G/L)||Standard Deviation|Mean
36911|NCT01494584|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|From the start of the first titration until follow-up (assessed up to 46 days)|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
36912|NCT01494584|Primary|Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine|The volume of distribution (Vd/F) is defined as MRT*CL/F, where MRT is the mean residence time (calculated as AUMC[0-tau]/AUC[0-tau], where AUMC[0-tau] is the area under the first moment curve determined as the area under the concentration*time versus time curve). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate the apparent volume of distribution.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Geometric Mean
36913|NCT01494584|Primary|Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine|Cmax is defined as the first occurrence of the maximum observed plasma concentration. Ctau refers to the pre-dose (trough) concentration after the dosing interval which is equal to the minimum observed concentration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate Cmax and Ctau.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population||Nanograms/Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
36915|NCT01494584|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine|The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC[0-tau]). The area under the plasma concentration-time curve over the dosing interval (AUC[0-tau]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate AUC(0-tau).|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of study medication) for whom a pharmacokinetic sample was obtained and analyzed||Hour*Nanograms/Milliliter (h.ng/mL)||95% Confidence Interval|Geometric Mean
36916|NCT01494545|Primary|Likert Statement: I am Interested in Purchasing These Contact Lenses.|The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36917|NCT01494545|Primary|Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:|The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36918|NCT01494545|Secondary|Investigator's Rating of Ease of Fit|"The investigator indicated agreement/disagreement with the statement, The study lenses were easy to fit for this subject, by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree."|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36919|NCT01494545|Secondary|Investigator's Overall Impression of Surface Wettability by Visit|The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36920|NCT01494545|Secondary|Investigator's Satisfaction With Lens Fit by Visit|The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36921|NCT01494545|Secondary|Duration of Overall Training Time|The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Minutes||Standard Deviation|Mean
36922|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of eyes|Participants||Number
36923|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 7|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of eyes|Participants||Number
36924|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of eyes|Participants||Number
36925|NCT01494545|Primary|Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36926|NCT01494545|Primary|Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36927|NCT01494545|Primary|Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36928|NCT01494545|Primary|Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36929|NCT01494545|Primary|Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36930|NCT01494545|Primary|Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36931|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36932|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Percentage of participants|||Number
36933|NCT01494545|Primary|Average Comfortable Daily Wear Time by Visit|Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Hours||Standard Deviation|Median
36934|NCT01494545|Primary|Overall Quality of Vision by Visit|Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36935|NCT01494545|Primary|Quality of Vision at End of Day by Visit|Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36936|NCT01494545|Primary|Quality of Vision During the Day by Visit|Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36937|NCT01494545|Primary|Quality of Vision at Insertion by Visit|Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36938|NCT01494545|Primary|Initial Quality of Vision|Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36939|NCT01494545|Primary|Overall Comfort by Visit|Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36940|NCT01494545|Primary|Comfort at End of Day by Visit|Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36941|NCT01494545|Primary|Comfort During the Day by Visit|Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36942|NCT01494545|Primary|Comfort at Insertion by Visit|Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36943|NCT01494545|Primary|Initial Comfort|Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.||Units on a scale||Standard Deviation|Mean
36944|NCT01494532|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here. All participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.|From start of study treatment until end of treatment (assessed up to 18 weeks)|ITT Population. Participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.||Percentage of participants|||Number
36945|NCT01494532|Secondary|Change From Baseline in UPDRS Part I at Week 4 of the Maintenance Period|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and par. were tested during the on phase of PD. This component of the UPDRS is the total score for 4 items (the items 1 to 4 include intellectual impairment, thought disorder, motivation / initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician. The higher score (16) indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component would also be missing. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline (BL) and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
36946|NCT01494532|Secondary|"Change From Baseline in UPDRS ADL Score With Participants in an Off State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test was performed when the par is in the off state of PD. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
36947|NCT01494532|Secondary|"Change From Baseline in UPDRS Activities of Daily Living (ADL) Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test were performed when the par. is in the on state of PD. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
36948|NCT01494532|Secondary|"Change From Baseline in Unified Parkinson Disease Rating Scale (UPDRS) Motor Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the par.. One of the six features include the Part III-motor examination where scores can range 0 to 108 with par. in an on state where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Score on scale||95% Confidence Interval|Least Squares Mean
36949|NCT01494532|Secondary|Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep as a Percentage of a 24-hour Day, at Week 4 of the Maintenance Period|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. The percentage of a 24-hour day spent asleep during the night time hours = Total sleep hours during the night time hours of sleep divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Percentage of time in hours||95% Confidence Interval|Least Squares Mean
36950|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of a 24-hour day spent on = Awake time spent on divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
36981|NCT01494350|Secondary|Number of Index Lesions With Reepithelialization Throughout the Study|Number of index lesions with 100% reepithelialization on Days 28 and 42.|Measured at day 28 and 42|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.||lesions|Participants||Number
36951|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24- Hour Day Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit. The total number of day awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percentage of 24 hr day spent on without TD= awake time spent on without TD divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
36952|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of 24 hour day spent off= awake time spent off divided by 24 x 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
36953|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of awake time spent on= Awake time spent on divided by (Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
36954|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit of the study. The total number of awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hr spent on without TD in each 24-hr diary card. Percentage of awake time spent onwithout TD= Awake time spent on without TD divided by(Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting BL values from MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
36955|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility(bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of awake time spent off= Awake time spent off divided by (Awake time spent off + Awake time spent on) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
36956|NCT01494532|Secondary|Percent Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep, at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL value × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Percentage of total sleep time in hours||95% Confidence Interval|Least Squares Mean
36987|NCT01493947|Other Pre-specified|Time to Relapse|Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.|Week 16 up to Week 52|||Median days to relapse||95% Confidence Interval|Median
36957|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to recordawake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
36958|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
36959|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values multiplied (×) the results with 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
36960|NCT01494532|Secondary|Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
36961|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on at Week 4 of the Maintenance Period"|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of the awake hours spent on in each 24 hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
36962|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in Parkinson's Disease (PD). TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24 hour diary card. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from Mixed Model Repeated Measures (MMRM). Par with a non-missing efficacy observation at BL and during the MP were analyzed."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
36963|NCT01494532|Secondary|Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2. The Generalized Estimating Equations (GEE) model was used to determine CGI responder rate with treatment, visit, and treatment by visit interaction included in the model. Only scheduled visits were included."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Percentage of participants|||Number
36964|NCT01494532|Secondary|"Percentage of Participants With a >=2 Hours Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||percentage of participants||95% Confidence Interval|Least Squares Mean
36965|NCT01494532|Secondary|"Percentage of Participants With a >=1 Hour Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||percentage of participants||95% Confidence Interval|Least Squares Mean
36966|NCT01494532|Secondary|"Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period"|"The responder rate was defined as the percentage of par with greater than or equal to (>=) 20 percent (%) reduction in their individual BL off time at Week 4 of the Maintenance Period. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. Responder Rate (Least Squares [LS] means on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline total awake time 'Off', treatment, visit and treatment*visit are included in the model."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||percentage of participants||95% Confidence Interval|Least Squares Mean
36967|NCT01494532|Primary|"Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period"|"Off time is defined as the state in which the participants(par) symptoms include lack of mobility(bradykinesia) with or without additional features such as tremor or rigidity. Par were asked to record awake time “off ”, awake time on, troublesome dyskinesias(TD) during awake time on, or time asleep for 30 minute intervals in 24 hr diary cards for 2 days preceding visits. Total number of awake hrs spent off per 24-hr period was the average of the 2 diary cards of the sum of awake hours spent off in each 24-hr diary card. BL is the last non-missing assessment measured on or before the first dose, change from BL was calculated by subtracting the BL values from the MP Week 4 values. Mixed Model Repeated Measures (MMRM) model used BL total awake time 'Off', treatment, visit and treatment by visit"|Baseline and Week 4 of the Maintenance Period (Study Week 17)|The Intent to Treat(ITT) Population included all randomized par who received at least one dose of study medication, had a BL efficacy assessment for the outcome, and at least one respective Post-BL efficacy assessment. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.||Hours||95% Confidence Interval|Least Squares Mean
36968|NCT01494506|Secondary|Pharmacokinetic Measurements of Total Irinotecan|Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.|6 weeks after first study drug administration|PK population was based on Protocol, all participants who received the appropriate dose of MM-398.||Total irinotecan = ug/L; SN38= ug/L||Geometric Coefficient of Variation|Geometric Mean
36969|NCT01494506|Secondary|EORTC-QLQ-C30|This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.||percent of patients in category|||Number
36970|NCT01494506|Secondary|Percentage of Patients With Tumor Marker (CA 19-9) Response|Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|Patients with elevated baseline CA19-9 value (> 30 U/mL) who received study drug.||percent of participants with TMR|||Number
36982|NCT01494350|Secondary|Area of Index Lesions Throughout the Study|Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.|Measured at day 0, 20, 28, 42, and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (1 index lesion) who withdrew on Day 18.||mm^2|Participants|Standard Deviation|Mean
36983|NCT01494350|Primary|Final Clinical Cure Rate for the Index Lesion|Number of index lesions with 100% reepithelialization at Day 98.|Final clincial cure is measured at day 98|modified intent to treat (mITT)||lesions|Participants||Number
36984|NCT01494298|Secondary|Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.||at study entry|||mg/dL||Standard Error|Least Squares Mean
36988|NCT01493947|Primary|Percent Change in Inflammatory Lesions From Baseline to Week 16|Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period|Baseline and Week 16|||percentage of change||Standard Deviation|Mean
36971|NCT01494506|Secondary|Percentage of Patients With Clinical Benefit Response|"Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either:~(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.~With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.~Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period."|Randomization to treatment discontinuation.The maximum time in follow up was 25 months|"Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR:~baseline pain intensity ≥ 20 (out of 100)~baseline morphine consumption ≥ 10 mg/day PO morphine equivalents~baseline KPS of 70 to 90 points"||percentage of participants with CBR|||Number
36972|NCT01494506|Secondary|Time to Treatment Failure|Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.|Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months|ITT Population||months||95% Confidence Interval|Median
36973|NCT01494506|Secondary|Objective Response Rate|The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.|Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.|ITT Population||percentage with confirmed response||95% Confidence Interval|Number
36974|NCT01494506|Secondary|Progression Free Survival|"Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|Randomization until disease progression or death from any cause; Until the data cut off of 14 Feb 2014. The maximum time in follow up was 25 months.|ITT Population||months||95% Confidence Interval|Median
36975|NCT01494506|Primary|Overall Survival|"Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.|Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.||months||95% Confidence Interval|Median
36976|NCT01494467|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|||Percentage of change in lesion counts||Standard Deviation|Mean
36977|NCT01494467|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT||Lesion count change||Standard Deviation|Mean
36978|NCT01494467|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT||Percentage of participants|||Number
36979|NCT01494350|Secondary|Number of All Ulcerated Lesions With Reepithelialization on Day 28|Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28|Measured on day 28|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.||lesions|Participants||Number
36980|NCT01494350|Secondary|Area of All Ulcerated Lesions Throughout the Study|Area of all ulcerated lesions on Days 20, 28, 42, and 98.|Measured at day 20, 28, 42 and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (2 lesions) who withdrew on Day 18.||mm^2|Participants|Standard Deviation|Mean
36989|NCT01493687|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT||Percentage of change in lesion counts||Standard Deviation|Mean
36990|NCT01493687|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT||Lesion count change||Standard Deviation|Mean
36991|NCT01493687|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT||Percentage of participants|||Number
36992|NCT01493557|Secondary|Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom|Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.|Week 8|Full Analysis Set (FAS)||days||Standard Deviation|Mean
36993|NCT01493557|Secondary|Rates of Complete or Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS).||percentage of participants|||Number
36994|NCT01493557|Secondary|Rates of Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
36995|NCT01493557|Secondary|Rates of Complete Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full analysis Set (FAS).||percentage of participants|||Number
36996|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
36997|NCT01493557|Secondary|Rate of Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
36998|NCT01493557|Secondary|Rate of Complete Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 8|Full Analysis Set (FAS)||percentage of participants|||Number
36999|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)||percentage of participants|||Number
37000|NCT01493557|Secondary|Rate of Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)||percentage of participants|||Number
37001|NCT01493557|Primary|The Rate of Complete Effectiveness of Initial GIS Management Strategy|"The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 4|Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies.||percentage of participants|||Number
37002|NCT01493531|Secondary|Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 months|||Proportion of Subjects|||Number
37005|NCT01493427|Secondary|Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.||Percentage of participants|||Number
37006|NCT01493427|Primary|Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|"The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit (N=187). Here, n is the number of participants with non-missing values at the specific time point."||millimeters mercury (mmHg)||Standard Deviation|Mean
37007|NCT01493180|Primary|Change in the Keratoconjunctival Staining Score From Baseline|"Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better.~The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test."|Basekine, 4 weeks|||scores on a scale||Standard Deviation|Mean
37008|NCT01493167|Primary|Efficient Casting With Woodcast Circular System|Efficient casting conduc ted with Novel Woodcast material|1 - 6 weeks|||participants|||Number
37009|NCT01493089|Secondary|Percentage of Patients Responding in 90 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes|14 days|mITT||Percentage of patients||95% Confidence Interval|Number
37010|NCT01493089|Secondary|Percentage of Patients Responding in 60 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes|14 days|mITT||Percentage of patients||95% Confidence Interval|Number
37011|NCT01493089|Secondary|Percentage of Patients Responding in 45 Minutes|percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes|up to 14 days|mITT||percentage of patients||95% Confidence Interval|Number
37012|NCT01493089|Secondary|Median Time to Sustained Total Relief|Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more|14 days|mITT||Minutes||95% Confidence Interval|Median
37013|NCT01493089|Secondary|Median Time to Sustained Partial Response|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days|mITT||Minutes||95% Confidence Interval|Median
37014|NCT01493089|Primary|Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days following treatment|mITT||Minutes||95% Confidence Interval|Median
37015|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment|||Seconds||Standard Deviation|Mean
37016|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment|||Incorrect Responses||Standard Deviation|Mean
37017|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following baseline assessment|||Seconds||Standard Deviation|Mean
37018|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following Baseline assessment|||Incorrect Responses||Standard Deviation|Mean
37019|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following baseline assessment|||Correct responses||Standard Deviation|Mean
37020|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following Baseline assessment|||Percentage of responses||Standard Deviation|Mean
37021|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The Wcst is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
37022|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment|||Percentage of responses||Standard Deviation|Mean
37023|NCT01492439|Secondary|The Trail Making Part B at 6 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment|||Seconds||Standard Deviation|Mean
37024|NCT01492439|Secondary|The Trail Making Test Part B at 3 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment|||Seconds||Standard Deviation|Mean
37025|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|6 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
37026|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|3 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
37027|NCT01492439|Secondary|The Trail Making Test Part A at 6 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment|||Seconds||Standard Deviation|Mean
37028|NCT01492439|Secondary|The Trail Making Test Part A at 3 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment|||Seconds||Standard Deviation|Mean
37029|NCT01492439|Secondary|The California Verbal Learning Test at 6 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|6 months following Baseline assessment|||Correct responses||Standard Deviation|Mean
37030|NCT01492439|Secondary|The California Verbal Learning Test at 3 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|3 months following Baseline Assessment|||Correct responses||Standard Deviation|Mean
37031|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 6 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|6 months following Baseline assessment|||units on a scale||Standard Deviation|Mean
37032|NCT01492439|Secondary|The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|6 months following Baseline assessment|||units on a scale||Standard Deviation|Mean
37033|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 3 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|3 months following Baseline|||units on a scale||Standard Deviation|Mean
37034|NCT01492439|Secondary|Positive and Negative Symptoms Scale (PANSS) Score at 3 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|3 months following baseline|||units on a scale||Standard Deviation|Mean
37035|NCT01492439|Primary|Completion of Academic Semesters|During the study period, course instructors provided information as to whether participants had completed or withdrawn from academic semester 1 and 2. This data was used to determine whether completion of academic semesters might be explained by attending cognitive remediation alongside supported education. At the end of the each semester, course instructors notified the research team as to whether participants had completed or not completed the academic semester. The unit of measure, 'course completed' refers to the completion of the required number of courses in that academic semester to progress through to the next semester.|The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)|||Courses completed||Standard Deviation|Mean
37036|NCT01492426|Secondary|Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1a participants assessed for SVR12 response.||Percentage of participants||95% Confidence Interval|Number
37037|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)|SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.|Week 24 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR24 response.||Percentage of participants||95% Confidence Interval|Number
37038|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for cEVR response.||percentage of participants||95% Confidence Interval|Number
37039|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12|eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.|Week 4, Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for eRVR response.||Percentage of participants||95% Confidence Interval|Number
37040|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for RVR response.||Percentage of participants||95% Confidence Interval|Number
37041|NCT01492426|Primary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR12 response.||Percentage of participants||95% Confidence Interval|Number
37042|NCT01492400|Secondary|Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)|FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).|Baseline, Month 12|Intent-to-Treat: all randomized patients||Square Millimeters (mm^2)||Standard Deviation|Mean
37043|NCT01492400|Secondary|Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye|OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).|Baseline, Month 12|Intent-to-Treat: all randomized patients||Microns||Standard Deviation|Mean
37044|NCT01492400|Primary|Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 12 Months|Intent-to-Treat: all randomized patients||Letters||Standard Deviation|Mean
37045|NCT01491984|Secondary|Time to Successful Intubation|Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.|intraoperative||||||
37046|NCT01491984|Secondary|Operator Rating of Difficulty|The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.|intraoperative||||||
37047|NCT01491984|Secondary|Number of Intubation Attempts|Number of intubation attempts was recorded after intubation was completed.|intraoperative||||||
37048|NCT01491984|Primary|Cormack-Lehane Grade|"The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale.~Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen"|intraoperative|||participants|||Number
39251|NCT01462227|Secondary|Cortisol (ug/dL)|Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||ug/dL||Standard Deviation|Mean
37049|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements (note: the participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40. The mean from the blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in diastolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).||mmHg||Standard Deviation|Mean
37050|NCT01491919|Secondary|Change in Systolic Blood Pressure (BP) From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements. Note: these participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40 (inclusive). The mean of these blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in systolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).||mmHg||Standard Deviation|Mean
37051|NCT01491919|Secondary|Change in Systolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.~Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).~The mean from these measurements was calculated."|Baseline to Day 14 (+/- 3 days)|Change in systolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care (SOC) group which are reported separately).||mmHg||Standard Deviation|Mean
37052|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.~Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).~The mean of these measurements was calculated."|Baseline to Day 14 (+/-3 days)|Change in diastolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care group which are reported separately).||mmHg||Standard Deviation|Mean
37053|NCT01491919|Secondary|Change in Urine Protein/Creatinine From Baseline in Lisinopril-naive Participants.|Change in urine protein/creatinine obtained as follows: Mean change (worst post-dose from baseline) presented for urine protein/creatinine ratio. Geometric mean of the ratio (worst post-dose / baseline with Geometric Coefficient of Variation percent (CV%) and greatest decrease presented for eGFR by dose group. Two patients in the high dose group had an evaluable urine protein/creatinine change.|Baseline to worst post-dose before Day 14 (+/- 3 days)|||mg/mg||Geometric Coefficient of Variation|Geometric Mean
37054|NCT01491919|Secondary|Largest eGFR Percent Decrease From Baseline in Lisinopril-naive Participants|"The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitor (ACEI) mediated reduction in kidney function.~Largest eGFR percent decrease from baseline reported in results section."|Baseline to Day 14 (+/- 3 days)|||percentage|||Number
37055|NCT01491919|Primary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) During/After Study Drug Administration|Number of Adverse Events (AEs) related and not related to study drug; number of Serious Adverse Events (SAEs) related and not related to study drug|First dose of study drug to 30 days after final study visit for AEs and until resolution for SAEs|||events|||Number
37056|NCT01491919|Primary|PK Renal Clearance (CLrenal)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CLrenal. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose.|||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
37057|NCT01491919|Primary|PK - Oral Clearance (CL/F)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CL/F. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and at 1, 2, 4, 5, 8, 12, and 24 hrs after dose|||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
37058|NCT01491919|Primary|PK - Time of the Maximum Observed Concentration in Plasma (Tmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of plasma lisinopril concentration. Medium was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose|||hours||Full Range|Median
37059|NCT01491919|Secondary|Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants|The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitors (ACE-I)-mediated reduction in kidney function. eGFR ratio was computed from the worst post-dose value divided by the Baseline value.|Baseline to Day 14 (+/- 3 days)|||ratio||Geometric Coefficient of Variation|Geometric Mean
37060|NCT01491919|Secondary|Change in Potassium Level From Baseline in Lisinopril-naive Participants|Potassium values will be obtained at Baseline and Day 14 prior to the final dose of study drug. Mean calculated from the two measurements.|At baseline visit and Day 14 prior to final study dose.|||mEq/L||Standard Deviation|Mean
37061|NCT01491919|Primary|PK - Maximum Observed Concentration of Drug in Plasma (Cmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of Cmax. Geometric mean was calculated from all measurements.|Day14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
37062|NCT01491919|Primary|Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of AUC. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 days) of lisinopril therapy at hours 0 (pre-dose) and 1,2,4,5,8,12 and 24 hrs after dose|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
37063|NCT01491672|Secondary|Duration of Response (DoR)|DoR was defined as the time from the first occurrence of PR or CR (as per local radiological review) until the date of the first documented disease progression or death due to underlying cancer.|20 months|The FAS was considered for this analysis. The FAS included all enrolled participants. Only participants who achieved a CR or PR were analyzed. Therefore, actual n=4,3,3,10.||months||95% Confidence Interval|Median
37064|NCT01491672|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants with best overall response of CR or PR based on the local radiological data according to the RECIST 1.0 Criteria|20 months|The FAS was used. It included all enrolled participants.||Participants|||Number
37065|NCT01491672|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease based on the local radiological data according to the RECIST 1.0 criteria.|20 months|The FAS was used. It included all enrolled participants.||Participants|||Number
37066|NCT01491672|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause.|28 months|The FAS was used. It included all enrolled participants.||months||95% Confidence Interval|Median
37067|NCT01491672|Secondary|Duration of PFS for Each First-line Treatment Cohort|Duration of PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. Participants' assessment was based on the local radiological data according to the RECIST 1.0 Criteria.|20 months|The FAS was used. It included all enrolled participants.||months||95% Confidence Interval|Median
37068|NCT01491672|Primary|Progression-free Survival (PFS) - All Participants|PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. The primary analysis of PFS was based on a local radiology review of CT scans and MRI collected until the participant experienced disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.|20 months|The full analysis set (FAS) was used. It included all enrolled participants.||months||95% Confidence Interval|Median
37069|NCT01491633|Post-Hoc|Time on Study|Number of days participant remained on study|2 years|||days||Standard Deviation|Mean
37070|NCT01491633|Secondary|Toxicities|Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.|2 years|||grade 3 toxicities|||Number
37071|NCT01491633|Secondary|Survival|Establish the overall survival of patients with SCC treated with dasatinib|2 years|One subject who was alive at the end of the study was censored from the survival analysis||days||Standard Deviation|Mean
37072|NCT01491633|Secondary|Types and Frequency of DDR2 Mutations|Determine frequency of DDR2 mutations in study patients|2 years|||participants|||Number
37073|NCT01491633|Primary|Response Rate|Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib|2 years|||percent|||Number
37074|NCT01491607|Secondary|Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||percentage of participants|||Number
37075|NCT01491607|Secondary|Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||participants|||Number
37076|NCT01491607|Secondary|Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||percentage of participants|||Number
37077|NCT01491607|Secondary|Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).||participants|||Number
39252|NCT01462227|Secondary|Glucagon (pg/mL)|Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||pg/mL||Standard Deviation|Mean
37078|NCT01491607|Secondary|Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Days 63 to 100|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive.||percentage of participants||95% Confidence Interval|Mean
37079|NCT01491607|Secondary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 70 +/- 2 days|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days.||percentage of participants||95% Confidence Interval|Least Squares Mean
37080|NCT01491607|Primary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 63 +/- 2 days|Subjects who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.||percentage of participants||95% Confidence Interval|Mean
37081|NCT01491490|Primary|Change in Bodyweight.|Efficacy of a 40:1 ratio of GWP42003:GWP42004 compared with placebo in the change from baseline in body weight after 42 days (6 weeks) in subjects currently being treated with olanzapine for schizophrenia or other non-affective psychosis.|6 weeks from Baseline.|||Kg|||Number
37082|NCT01491113|Secondary|Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated according: CLHD=CLD+CLUF.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mL/min||Geometric Coefficient of Variation|Geometric Mean
37083|NCT01491113|Secondary|Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mL/min||Geometric Coefficient of Variation|Geometric Mean
37084|NCT01491113|Secondary|Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mL/min||Geometric Coefficient of Variation|Geometric Mean
37085|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period|tmax refers to the time to reach maximum plasma concentration (tmax).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
37086|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
37087|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 140 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Full Range|Median
37088|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period|tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
37089|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L057 for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
37090|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Full Range|Median
37091|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D|"tmax refers to the time to reach maximum plasma concentration (tmax).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
37092|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Geometric Coefficient of Variation|Geometric Mean
37093|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
37094|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D|"tmax refers to the time to reach maximum plasma concentration of ucb L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||hours||Full Range|Median
37095|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Geometric mean and Coefficient of Variation (CV) was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Full Range|Median
37096|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L057 for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
37097|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D|"Ae refers to the total amount of ucb L057 excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mg||Geometric Coefficient of Variation|Geometric Mean
37098|NCT01491113|Secondary|Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D|"The Non-Renal Clearance (CLNR) describes the removal of drug by organs other than the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
37099|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
37113|NCT01491035|Primary|AUC(0-24h) of Lu AA34443|Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set||ng*h/mL||Standard Deviation|Median
37100|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||L/h||Geometric Coefficient of Variation|Geometric Mean
37101|NCT01491113|Secondary|Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D|"fe refers to the fraction of dose excreted in urine of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||Percentage of Dose Administered||Geometric Coefficient of Variation|Geometric Mean
37102|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D|"Ae refers to the total amount of ucb L059 (Levetiracetam) excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||mg||Geometric Coefficient of Variation|Geometric Mean
37103|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
37104|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L057.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
37105|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
37106|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
37107|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
37108|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D|"Cmax refers to the maximum observed concentration of ucb L057.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
37109|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
37110|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D|"Cmax refers to the maximum observed concentration of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
37117|NCT01491035|Primary|Cmax of Vortioxetine|Maximum plasma concentration of vortioxetine|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set = all patients who took at least one dose of IMP and who contributed with both Day 1 pre-dose pharmacokinetic sampling data and sufficient post-dose sampling data for estimation of the pharmacokinetic parameters.||ng/mL||Standard Deviation|Median
37118|NCT01490931|Primary|Comparison of Pain Intensity Scores at 6 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||6 Hours post-dose|||millimeters||Standard Error|Mean
37119|NCT01490931|Primary|Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||5 Hours post-dose|||millimeters||Standard Error|Mean
37120|NCT01490931|Primary|Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||4 Hours post-dose|||millimeters||Standard Error|Mean
37121|NCT01490931|Primary|Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||3 hours post-dose|||millimeters||Standard Error|Mean
37122|NCT01490931|Primary|Comparison of Pain Intensity Scores at 2 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||2 Hours|||millimeters||Standard Error|Mean
37123|NCT01490931|Primary|Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||90 minutes post-dose|||millimeters||Standard Error|Mean
37124|NCT01490931|Primary|Comparison of Pain Intensity Scores at 60 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period|VAS pain intensity score 60 minutes after dosing.|60 minutes post dose|||millimeters||Standard Error|Mean
37125|NCT01490931|Primary|Comparison of Pain Intensity Scores at 40 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|VAS pain intensity score at 40 minutes post-dose|40 minutes post dose|||millimeters||Standard Error|Mean
37126|NCT01490931|Secondary|Median Onset of Meaningful Pain Relief|Measure obtained using recognized double-stop watch technique. Patient is asked to depress the second stop watch when pain relief is meaningful to them. Each patient decides what meaningful relief is for them.|At time of depressing meaningful relief stopwatch up to 6 hours.|||seconds||95% Confidence Interval|Median
37127|NCT01490931|Secondary|Most Frequent Number of Days of Analgesic Dosing in Dental Implant Surgery Patients When Employing Intranasal Ketorolac as Their Pain Medication.|Self explanatory|Up to 5 days|||days|||Number
37128|NCT01490931|Secondary|Percentage of Subjects Who Reach a Level of at Least Moderate Pain by Achieving a Score of at Least 40 mm on a 100 mm Visual Analog Scale Within 5 Hours After the Completion of Surgery.||Up to 5 hours after last suture is placed|All subjects (regardless of pain intensity) receiving one to three dental implants||percentage of participants|||Number
37129|NCT01490931|Primary|Comparison of Pain Intensity Scores at 20 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale|20 minutes post dose|||millimeters||Standard Error|Mean
37130|NCT01490931|Secondary|The Median Onset of First Perceptible Pain Relief of Intranasal Ketorolac in Dental Implant Surgery Patients|Data will be obtained employing the well-described double stop watch technique|Censored at 6 hours|||seconds||95% Confidence Interval|Median
37131|NCT01490866|Secondary|Frequency of Adverse Events as a Measure of Safety|The frequency of adverse events (AEs) was analyzed in 2 groups of patients, those receiving FOLFOX/bevacizumab (N=70), and patients who received axitinib maintenance (N = 48). AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.|||participants|||Number
37132|NCT01490866|Secondary|Overall Survival (OS)|Defined as the time from first treatment until death from any cause.|every 8 weeks until progression then every 3 months for up to 5 years.|||months||95% Confidence Interval|Median
37133|NCT01490866|Secondary|Time To Progression (TTP)|Defined as the time after a disease is diagnosed (or treated) until worsening of the disease.|every 8 weeks, assessed approximately up to 24 months|||months||95% Confidence Interval|Median
37134|NCT01490866|Secondary|Objective Response Rate|Defined as the percentage of evaluable patients showing a complete or partial response (CR or PR) per RECIST v1.1 criteria. CR = disappearance of all lesions. PR = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks, assessed up to approximately 24 months|||percentage of participants|||Number
37135|NCT01490866|Primary|Progression-free Survival|Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.|24 months|All patients who received at least one dose of any study drug.||months||95% Confidence Interval|Median
37136|NCT01490840|Secondary|Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A positive change from baseline indicates improvement.|Baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.||L/s||95% Confidence Interval|Least Squares Mean
37137|NCT01490840|Secondary|Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||[ml/min/kg][watt/kg body weight]||95% Confidence Interval|Least Squares Mean
37138|NCT01490840|Secondary|Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory Second Edition (BDI-II) is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders Fourth Edition. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II. There is a four-point scale for each item ranging from 0 to 3. The total score ranges from 0 - 63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
37139|NCT01490840|Secondary|Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)|The WEIMuS (Würzburg Fatigue Inventory for MS) scale is a validated self-assessment instrument to quantify the degree of fatigue. The scale consists of 17 items with 5 categories that are scored from ‘0’ to ‘4’. The subscores for cognitive and physical fatigue range from 0 to 36 and from 0 to 32, respectively, with the total sum score ranging from 0 to 68; higher scores indicate higher degrees of fatigue. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
37140|NCT01490840|Secondary|Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)|The Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) consists of 44 items, 28 of which are the basis for computation of five subscale scores reflecting major dimensions of health-related quality of life (HRQoL) in MS: Fatigue/Thinking (4 items), Mobility lower limb (5 items), Mobility upper limb (5 items), Social function (6 items) and Mood (eight items). Subscales and total score range from 1 to 5, with high scores indicating a lower quality of life. In this study, the total score and following 3 subscales: fatigue/thinking, mobility lower limb and mobility upper limb only were analyzed. A negative change from baseline indicates improvement.|Baseline, 6 months, 12 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
37141|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).~Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||joule||95% Confidence Interval|Least Squares Mean
37142|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).~Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||newton meter||95% Confidence Interval|Least Squares Mean
37143|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test|The Sit to Stand Test is a functional outcome measure of the lower-extremity muscle power. The test was performed 3 times with one minute rest in between. The best attempt out of three was used for the analysis. A positive change from baseline indicates improvement.|baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.||watt/kilogram body weight||95% Confidence Interval|Least Squares Mean
37144|NCT01490840|Primary|Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).|The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.||score on a scale||95% Confidence Interval|Least Squares Mean
37145|NCT01490294|Secondary|Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)||Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in FAS with assessment for this outcome measure. Evaluation included all participants in the full analysis population with an assessment for this outcome measure||Percentage of participants|||Number
37146|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure||Percent segmental assessment|Participants||Number
37147|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|PPS. Evaluation included all participants in the per protocol population with an assessment for this outcome measure||Percent segmental assessment|Participants||Number
37157|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
37148|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent regional assessment|Participants||Number
37149|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent segmental assessment|Participants||Number
37150|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent segmental assessment|Participants||Number
37151|NCT01490294|Secondary|Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.||Percent regional assessments|Participants||Number
37152|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
37153|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
37154|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
37155|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
37156|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment||Participants|||Number
37158|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
37159|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
37160|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
37161|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
37162|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
37163|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
37164|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
37165|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Delayed enhancement assessments|Participants||Number
37166|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.||Participants|||Number
37167|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. The evaluation included only participants with delayed enhancement in at least 1 segment ( PPS) based on the assessment of at least one blinded reader.||Delayed enhancement assessments|Participants||Number
37168|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement (DE)-[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessment|Participants||Number
37219|NCT01490190|Primary|Number of Participants With Regular Menstrual Cycles|The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37169|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
37170|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
37171|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."||Percent regional assessments|Participants||Number
37172|NCT01490294|Secondary|Time to Peak Based on Segments|"Time to peak is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes|PPS||Seconds||Standard Deviation|Mean
37173|NCT01490294|Secondary|Upslope Based on Segments|"Upslope is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in Units/sec. The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Units/sec||Standard Deviation|Mean
37174|NCT01490294|Secondary|Signal Intensity (SIrel) Based on Segments|"The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Signal intensity||Standard Deviation|Mean
37175|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
37176|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
37177|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
37434|NCT01486927|Secondary|Cmax (Part 1)|Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||IU/dL||Standard Deviation|Mean
37178|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
37179|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions|For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure||Percent regional assessments|Participants||Number
37180|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI)  (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)"|MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI <=1.5 (perfusion defect) and >1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of >70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure||Percent regional assessments|Participants||Number
37181|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of > 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure||Percent regional assessments|Participants||Number
37182|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments|Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percentage of segments with artifacts|Participants||Number
37183|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments|Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percentage of segments with artifacts|Participants||Number
37184|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
37185|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
37202|NCT01490190|Secondary|Number of Participants Who Reported a Serious Adverse Event During the Study|A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
37186|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
37187|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
37188|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessment|Participants||Number
37189|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
37190|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
37191|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia. The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
37192|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."||Percent segmental assessment|Participants||Number
37193|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia.The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
39469|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 4 (week 2)||||||
37194|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
37195|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of scar. The number of regional assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
37196|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."||Percent segmental assessments|Participants||Number
37197|NCT01490294|Secondary|Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."||Percent regional assessments|Participants||Number
37198|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent segmental assessments|Participants||Number
37199|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS||Percent regional assessments|Participants||Number
37200|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)||Percent segmental assessment|Participants||Number
37201|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent [LAD], left circumflex [LCX], right coronary artery [RCA]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)||Percent regional assessments|Participants||Number
37218|NCT01490190|Primary|Average Number of Bleeding Days Per Cycle|Mean duration of menstruation, per day, per cycle, during the study period.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.||Days||Standard Deviation|Mean
37203|NCT01490190|Secondary|Number of Participants Who Reported at Least One Adverse Event During the Study|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
37204|NCT01490190|Secondary|Number of Pregnancies Due to Contraceptive Method Failure During the Study|For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Pregnancies|||Number
37205|NCT01490190|Primary|Number of Participants Who Would Recommend Vaginal Ring to Others|Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
37206|NCT01490190|Primary|Number of Participants Who Plan to Continue Using Vaginal Ring|Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
37207|NCT01490190|Primary|Participants' Overall Satisfaction With Vaginal Ring|Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.||Participants|||Number
37208|NCT01490190|Primary|Frequency of Partner Objecting to Vaginal Ring Use|Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37209|NCT01490190|Primary|Frequency of Partner Feeling Vaginal Ring During Intercourse|Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37210|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring During Intercourse|Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37211|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring at Any Time|Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37212|NCT01490190|Primary|Participants' Assessment of Ease of Removal of Vaginal Ring|Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37213|NCT01490190|Primary|Participants' Assessment of Ease of Insertion of Vaginal Ring|Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37214|NCT01490190|Primary|Number of Spotting Days Per Cycle|Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Participants in the Per Protocol Population who experienced spotting were evaluated for duration of spotting.||Days||Standard Deviation|Mean
37215|NCT01490190|Primary|Number of Bleeding Days Per Cycle|Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.|Up to 84 days (three 28-day cycles)|One participant in Per Protocol Population who experienced vaginal bleeding was evaluated for duration of bleeding.||Days||Standard Deviation|Mean
37216|NCT01490190|Primary|Number of Participants With Intermenstrual Bleeding/Spotting|Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.||Participants|||Number
37217|NCT01490190|Primary|Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring|Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.||Pads||Full Range|Median
47727|NCT01350245|Primary|Disease-Free Survival (DFS)|1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.|1 year post-transplant|||percentage of patients|||Number
37220|NCT01490125|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment|The number of puffs of rescue medication taken by participants, were collected each day during the study via entries in e-diaries|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||puffs||Standard Deviation|Least Squares Mean
37221|NCT01490125|Secondary|Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment|The Capacity of Daily Living during the Morning (CDLM) is a self-administered daily assessment. The CDLM asks COPD patients to (i) report their ability to carry out 6 morning activities and (ii) rate the difficulty in performing those activities on a five point Likert-type scale ranging from “not at all difficult” to “extremely difficult”. For each of the six morning activities a score ranging from 0 (=so difficult that they could not carry out the activity by themselves) to 5 (not at all difficult to carry out the activity by themselves) is calculated by using the responses from the two questions for each activity. Daily CDLM is calculated using the scores average from the 6 morning activities. CDLM is calculated as the average daily CDLM score over 6 weeks of treatment. The change from baseline in CDLM score over 6 weeks is analyzed using a MIXED model with baseline CDLM score as a covariate. A CDLM score of 0.20 is considered to be a minimal clinically important difference.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Units on a scale||Standard Error|Least Squares Mean
37222|NCT01490125|Secondary|Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Vital Capacity (FVC) is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC was measured via spirometry conducted according to internationally accepted standards at 5 min-4 hr post dose of day 1 and week 6.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Liters||Standard Error|Least Squares Mean
37223|NCT01490125|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Expiratory Volume in 1 second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were taken at 5 min- 4hr post-dose of day 1 and week 6. The standardized FEV1 Area under the curve (AUC) was calculated as the sum of trapezoids divided by the length of time.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Liters||Standard Error|Least Squares Mean
37224|NCT01490125|Secondary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Units on a scale||Standard Deviation|Mean
37225|NCT01490125|Primary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.||Units on a scale||Standard Deviation|Mean
37240|NCT01489956|Primary|Participants Demonstrating Tolerance to KLH Using T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part B)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI <3 on Day 32 indicated tolerance to KLH. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 32|Intent-to-treat||participants|||Number
37226|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale|The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
37227|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale|The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had receiving at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
37228|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale|The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
37229|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale – Severity (CGI-S)|Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
37230|NCT01490086|Primary|Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.||scores on a scale||Standard Deviation|Mean
37231|NCT01490060|Primary|Complete Response|Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.|From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).|Out of 40 eligible participants, 2 participants had change of treatment, 1 participant was noncompliant and 1 participant had an adverse event related to chemotherapy. 36 participants completed cycle 1 and cycle 2.||percentage of participants|||Number
37232|NCT01489956|Secondary|Compare the Level of KLH-specific Antibodies in the Serum (Samples From Various Time Points) Between Parts A and B|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.|||||
37233|NCT01489956|Secondary|Other Mechanistic Assessments on Archived Serum Samples Like Anti-KLH Antibodies and Secreted Cytokines (Part B)|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.|||||
37234|NCT01489956|Secondary|Suppression (or Non-activation) of T Cell Stimulation Index Measured by CFSE Staining After KLH Stimulation (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.|||||
37235|NCT01489956|Secondary|Suppression (or Non-activation) of Cytokine Secretion Profile of T Cells Stimulated by KLH Following Oral Feeding (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.|||||
37236|NCT01489956|Secondary|T Cell Stimulation Index Measured by Carboxyfluorescein Diacetate Succinimidyl Ester (CFSE) Staining After KLH Stimulation (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.|||||
37237|NCT01489956|Secondary|Cytokine Secretion Profile of T Cells Stimulated by KLH (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.|||||
37238|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses.|Day 16|Data were not collected and therefore no analyses could be performed.|||||
37239|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses|Day 9|Data were not collected and therefore no analyses could be performed.|||||
37286|NCT01489189|Secondary|Number of Eyes With Vitreous Hemorrhage||2-years|||Eyes|Eyes||Number
37241|NCT01489956|Primary|Participants With a Positive Immune Response to T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI ≥3 on day 16 will indicate the presence of immune response. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 16|Intent-to-treat||participants|||Number
37242|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist|Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.|8 months|||percentage of participants||95% Confidence Interval|Number
37243|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist|Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.|8 months|||percentage of participants||95% Confidence Interval|Number
37244|NCT01489891|Secondary|Percentage of Participants With Adverse Events in Both Groups|Hypoxemia (SatO2<90% or >4% if the baseline was under 93%), bradycardia (<60 bpm or >10% from baseline), hypotension (systolic blood pressure under 90 mmHg and/or diastolic 60 mmHg), anaphylactic reaction, aspiration o methaemoglobinemia.|Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure|||percentage of participants||95% Confidence Interval|Number
37245|NCT01489891|Primary|Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy|The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).|8 months|||mcg/kg/min||Standard Deviation|Mean
37246|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 8|Mean Cmax of Cremophor on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL/mL||Geometric Coefficient of Variation|Geometric Mean
37247|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 1|Mean Cmax of Cremophor on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL/mL||Geometric Coefficient of Variation|Geometric Mean
37248|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 8|Mean Cmax of Dexanabinol on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
37249|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 8|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
37250|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 1|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
37251|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 8|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
37252|NCT01489826|Secondary|Progression Free Survival|Tumour response evaluation using RECIST 1.1. (Assessment by CT scan or MRI).|At Screening and after every 2 cycles of treatment (+/-1 week)|Patients included in this analysis were from the 'Efficacy population', defined as those with a baseline and at least one post-baseline assessment of efficacy.||Days||Inter-Quartile Range|Median
37253|NCT01489826|Secondary|Number of Adverse Events (AEs)|AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials|30 +/-3 days from the end of the last infusion|The numbers represent the total number of AEs per group. Refer to AE tables for specific information.||Events|||Number
37254|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 1|Mean Cmax of Dexanabinol on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
37255|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 1|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
37256|NCT01489826|Primary|Number of Patients Experiencing Dose Limiting Toxicity (DLT)|"Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD).~3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no DLT has occurred. Upon occurrence of the first DLT within a cohort, an additional 3 patients were to be added to that cohort. For a six patient cohort, all 6 patients were to have completed their first dexanabinol treatment cycle with no more than 1 DLT before dose escalation to the next cohort. If 2 or more DLTs occur in a cohort, the next lower dose level will be declared the MTD.~DLTs will be graded for severity based on the National Cancer Institute (NCI) Common Terminology Criteria version 4.03."|Each patient will be followed for 22 days|Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the MTD (highest dose it is safe to give patients) or alternatively the Maximum Administered Dose(MAD). DLT evaluation in 3 to 6 patients at end of 1 treatment cycle||Number of patients with DLT|||Number
37257|NCT01489670|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.|Week 12|All participants with complete data available for IOP.||mm Hg||Full Range|Median
37258|NCT01489670|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|Week 12|All participants with data available for this outcome measure.||Participants|||Number
37259|NCT01489670|Secondary|Physician Reported Reasons for Early Discontinuation of Treatment|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 Weeks|All participants who discontinued treatment early.||Participants|||Number
37260|NCT01489670|Secondary|Physician Evaluation of Tolerability of Treatment|The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.|Week 12|All participants with data available for this outcome measure.||Participants|||Number
37261|NCT01489670|Secondary|Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.||Participants|||Number
37262|NCT01489670|Secondary|Physician Evaluation of Efficacy Using a 5-Point Scale|The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.||Participants|Participants||Number
37263|NCT01489670|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All participants with complete data available for IOP.||mm Hg||Full Range|Median
37264|NCT01489527|Secondary|Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58|The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.|18 Months|All treated participants||percentage of participants|||Number
37265|NCT01489527|Secondary|Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18|Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.|18 Months|Participants who were randomized to Gardasil and received all 3 doses of Gardasil||percentage of participants|||Number
37266|NCT01489527|Secondary|Percentage of Participants Who Were Seropositive by HPV Type|Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.|At Enrollment - 5 Month Enrollment Period|All treated participants||percentage of participants|||Number
37267|NCT01489527|Secondary|Study Compliance Rate|Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.|18 Months|All treated participants||percentage of participants|||Number
37268|NCT01489527|Primary|Human Papillomavirus (HPV) Rate|HPV type distribution and prevalence of each HPV type at enrollment.|At Enrollment - 5 Month Enrollment Period|All treated participants||participants|||Number
37269|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|24 weeks after the first vaccination|All subjects who received at least one vaccination||titre||95% Confidence Interval|Geometric Mean
37270|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|Pre-vaccination (Week 0)|All subjects who received at least one vaccination||titre||95% Confidence Interval|Geometric Mean
37271|NCT01489358|Secondary|Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)|ELISA titer (strain 37997) For ELISA, week 0 values were used to background correct titres for subsequent weeks.|24 weeks after the first vaccination|All subjects who received at least one vaccination||titre||95% Confidence Interval|Geometric Mean
37287|NCT01489189|Secondary|Development of Central DME With Vision Impairment by 2-years||2-years|Excludes that did not have central DME with vision impairment (20/32 or worse) at baseline.||eyes|Eyes||Number
37288|NCT01489189|Secondary|Mean Change in OCT Central Subfield Thickness From Baseline|All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.|2-years|Eyes with optical coherence tomography (OCT) data at baseline and 2-years.||µm|Eyes|95% Confidence Interval|Mean
37289|NCT01489189|Secondary|Frequency of Vitrectomy||2-years|||eyes|Eyes||Number
37272|NCT01489358|Primary|Number of Subjects Reporting 1 or More Unsolicited Adverse Event|"Unsolicited adverse events were recorded from enrollment through 28 days after the second vaccination; and from the third vaccination through 28 days after this vaccination.~Between and after the indicated time periods, through the last expected study visit (i.e., 24 weeks after the third vaccination), only SAEs and new chronic medical conditions were recorded. The number of unsolicited events reported for Group 3 here is lower than the total number of adverse events in the Adverse Event Module, which reports both solicited and unsolicited adverse events."|28 days after each vaccination|All subjects who received at least one vaccination||participants|||Number
37273|NCT01489358|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 44 weeks after the first vaccination.|44 weeks after first vaccination|All subjects who received at least one vaccination||participants|||Number
37274|NCT01489358|Primary|Number of Subjects With an Any Abnormal Laboratory Result|Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44|44 weeks after first vaccination|All subjects who received at least one vaccination||participants|||Number
37275|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after any vaccination|All subjects who received at least one vaccination||participants|||Number
37276|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination||participants|||Number
37277|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination||participants|||Number
37278|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination||participants|||Number
37279|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after any vaccination|Number of subjects who received at least one vaccination||participants|||Number
37280|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination||participants|||Number
37281|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination||participants|||Number
37282|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination||participants|||Number
37283|NCT01489254|Primary|The Number of T1-Gadolinium Enhancing Lesions During Months 7-9|The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.|9 months|Full Analyis Set (FAS): all randomized subjects who received at least 1 dose of trial medication||Number of lesions||95% Confidence Interval|Mean
37284|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss||2-year|Participants that completed the 2-year visit.||eyes|Eyes||Number
37285|NCT01489189|Secondary|Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years||2-years|Eyes with baseline diabetic retinopathy level 61B or worse (active neovascularization). Last-observation-carried-forward was used for 23 eyes in the anti-VEGF+Deferred PRP group and 25 eyes in the Prompt PRP group missing photographs at 2 years if 1-year fundus photographs were available.||eyes|Eyes||Number
37290|NCT01489189|Secondary|Humphrey Visual Field Test Cumulative Score Change From Baseline|Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test [for each quadrant], and from 0 to about 400 or 450 for the peripheral test.|2-years|Humphrey visual fields were obtained at a subset of sites. Fields with excessive false positive response, excessive false negative response, or excessive fixation loss were excluded from analysis. Twenty-two eyes in the anti-VEGF+deferred PRP group and 25 eyes in the prompt PRP group were excluded.||decibels|Eyes|Inter-Quartile Range|Median
37291|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain||2-years|Eyes with a baseline letter score of 78 or less (approximate Snellen equivalent 20/32 or worse) from participants that completed the 2-year visit.||eyes|Eyes||Number
37292|NCT01489189|Secondary|Mean Visual Acuity|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.||letters|Eyes|Standard Deviation|Mean
37293|NCT01489189|Primary|Mean Change in Visual Acuity From Baseline|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.||letters|Eyes|95% Confidence Interval|Mean
37294|NCT01488994|Secondary|Health Resource Use: Days Lost From School|The number of days lost from school per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who missed days from school||Days||Full Range|Median
37295|NCT01488994|Secondary|Health Resource Use: Emergency Room Visits|The number of Emergency Room visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|||Visits||Full Range|Median
37296|NCT01488994|Secondary|Health Resource Use: Unscheduled Doctor's Office Visits|The number of unscheduled doctor's Office visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who had unscheduled visits to a doctor's office||Visits||Full Range|Median
37297|NCT01488994|Secondary|Health Resource Use: Length of Hospitalization|The length of hospitalization per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|||Days||Full Range|Median
37298|NCT01488994|Secondary|Health Resource Use: Number of Hospitalizations|The number of hospitalizations per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|||Hospitalizations||Full Range|Median
37299|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): Haemo-QoL, Change From Baseline in Total Score|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline and 6 months|Participants in the Full Analysis Set who had Haemo-QoL data for baseline and 6 months||Scores on a scale||Standard Deviation|Mean
37300|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): PedsQL™ Change From Baseline in Total Score|"For this study, the PedsQL™ questionnaires for participants 2 to 7 years of age (parent-proxy versions for age groups 2-4 years and 5-7 years) and PedsQL™ Child version for participants 8 to 12 years of age were used.~The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. A 5-point score is used for each domain: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0 so that higher scores indicate better quality of life (QoL). The total score is the mean (average) of all scores from the 4 domains.~The change from baseline in total score is reported- a positive score indicates a better QoL compared to baseline and a negative score indicates a poorer QoL compared to baseline."|Baseline and 6 months|Participants in the Full Analysis Set who had PedsQL™ data for baseline and 6 months||Scores on a scale||Standard Deviation|Mean
37301|NCT01488994|Secondary|Safety: Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins and Recombinant Furin (rFurin)|If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.|Throughout study period (approximately 17 months)|||Participants|||Number
37302|NCT01488994|Secondary|Safety: Number of Participants With Clinically Significant Changes in Routine Laboratory Parameters (Haematology and Clinical Chemistry), and Vital Signs|"Categories consist of Clinically Significant (CS) changes in haemaotology parameters, clinical chemistry parameters and vital signs.~Abbreviations in categories; Clin=clinical; params=parameters"|Throughout study period (approximately 17 months)|||Participants|||Number
37303|NCT01488994|Secondary|Safety: Number of Participants With Thrombotic Events||Throughout study period (approximately 17 months)|||Participants|||Number
37305|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|"If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.~AB=antibodies in category for outcome measure data."|Throughout study period (approximately 17 months)|||Participants|||Number
37306|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout study period (approximately 17 months)|||Participants|||Number
37307|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Event|Event includes prophylactic infusions of study product and infusions of study product for treatment of bleeding episodes (BEs).|Throughout study period (approximately 17 months)|||IU/kg||Standard Deviation|Mean
37308|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Year (Annualized)||Throughout study period (approximately 17 months)|||IU/kg per year||Standard Deviation|Mean
37309|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Month||Throughout study period (approximately 17 months)|||IU/kg per month||Standard Deviation|Mean
37310|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Year||Throughout study period (approximately 17 months)|||Infusions per year||Standard Deviation|Mean
37311|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Month||Throughout study period (approximately 17 months)|||Infusions per month||Standard Deviation|Mean
37312|NCT01488994|Secondary|Hemostatic Efficacy: Prophylaxis: Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during prophylaxis was calculated only for participants who had adequate treatment time for bleeding rate assessment (i.e., more than 3 months of prophylaxis treatment). The observation period for prophylaxis was to be the time between the first and the last prophylactic infusions. The treatment period for surgery was to be excluded from the bleed rate calculation.~ABR calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25."|Throughout study period (approximately 17 months)|||Bleeding episodes per year||Standard Deviation|Mean
37313|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Resolution of Bleed|"Rating Scale for Treatment of bleeding episodes (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes||Bleeding Episodes|Participants||Number
37314|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode||Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes||Bleeding Episodes|||Number
37315|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) Over Time|"IR calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose. IR is determined at baseline (PK analysis), Week 5, Week 13 and Week 26 timepoints.~Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants > 6 years of age; pediatric participants 6 to <12 years of age; pharmacokinetic Full Analysis Set (PKFAS)."|Within 30 mins pre-infusion and 30 mins post-infusion at baseline, Week 5, Week 13 and Week 26.|||IU/dL : IU/kg||Standard Deviation|Mean
37316|NCT01488994|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Computed as Clearance (CL) * Mean residence time (MRT)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||dL/kg||Standard Deviation|Mean
37317|NCT01488994|Secondary|Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|Calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||hours (hr)||Standard Deviation|Mean
37318|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|The rise in FIX activity in IU/dL per unit dose administered in IU/kg. Calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose|Within 30 mins pre-infusion and 30 mins post-infusion|||IU/dL : IU/kg||Standard Deviation|Mean
37319|NCT01488994|Secondary|Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|Computed as the dose divided by total Area under the curve (AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||dL/(kg*hr)||Standard Deviation|Mean
37320|NCT01488994|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|Computed as total area under the first moment curve (total AUMC) divided by the total area under the concentration versus time curve (total AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||hours (hr)||Standard Deviation|Mean
38318|NCT01474200|Secondary|CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.|Within 30 days and 90 days after hospital discharge|||Days|||Number
37321|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity Post-infusion Per Dose (Total AUC/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"||IU*hour (hr)/dL||Standard Deviation|Mean
37322|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion Per Dose (AUC 0-72h/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints|On completion of the study, prospective changes to the planned statistical analysis were made not to analyze AUC 0-72h due to the different time points for the last PK blood sample. Only total AUC [i.e. AUC 0-infinity] was included in the PK analysis.|||||
37323|NCT01488994|Primary|Adverse Events (AEs) Possibly or Probably Related to BAX326||Throughout study period (approximately 17 months)|Full analysis set||AEs considered related to BAX326|||Number
37324|NCT01488877|Secondary|Change From Baseline in Sitting Pulse Rate at Day 15|Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
37325|NCT01488877|Secondary|Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15|Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.||millimeter of mercury (mmHg)||Standard Deviation|Mean
37326|NCT01488877|Secondary|Plasma Pharmacokinetic (PK) Parameters|PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.|0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14|Data for all pre-specified PK parameters were not analyzed because a decision was made to prematurely terminate the study.|||||
37327|NCT01488877|Primary|Number of Participants With Confirmed and Severe Hyperkalemia|Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level >= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.|Baseline up to Day 15|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
37328|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 15|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.|Baseline, Day 14, 15|Safety analysis set included all participants who received at least 1 dose of study medication.||mEq/L||Full Range|Median
37329|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 8|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.|Baseline, Day 7, 8|Safety analysis set included all participants who received at least 1 dose of study medication.||milliequivalent/liter (mEq/L)||Full Range|Median
37330|NCT01488578|Primary|Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.|The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.||events|||Number
37331|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment|Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37332|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day|Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37333|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)|Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37334|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency|Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37335|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder|Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37336|NCT01488578|Secondary|Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.||events|||Number
37337|NCT01488578|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy|Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor.|12 week|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
37338|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Age|Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37339|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Complications|Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37340|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Gender|Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37341|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies|Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37342|NCT01488578|Primary|Number of Participants With an Investigator’s Assessment of Clinical Outcome at End of the Study.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.|12 week|"The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.~Number of participants evaluable for which was evaluated effect."||participants|||Number
37343|NCT01488578|Primary|"Number of Participants Which Was Evaluated as Degree of Satisfaction."|Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37344|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs|Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
37345|NCT01488578|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|12 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.||participants|||Number
37346|NCT01488487|Secondary|Objective Response Rate (ORR)|"ORR is the rate of complete responses (CRs) + partial responses (PRs) as determined by RECIST (v1.1) and modified HCC RECIST criteria. Responses defined as follows:~CR: disappearance of all clinical/radiological evidence of tumor including any intratumoral arterial enhancement in all target lesions.~Partial Response (PR): at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, referencing the baseline sum.~Stable Disease (SD): any cases that do not qualify for either partial response or progressive disease.~Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of viable target lesions, referencing the nadir sum, and/or the appearance of one or more new lesions. A new hepatic nodule signals PD when the longest diameter is at least 10 mm and the nodule shows the typical vascular pattern of HCC on dynamic imaging or if at least 1-cm interval growth is seen in subsequent scans."|3.5 years|Two patients were not evaluable; one due to death prior to radiographic evaluation (death clinically attributed to progressive disease) and the other due to early termination of treatment due to intolerance.||percentage of participants|||Number
37347|NCT01488487|Secondary|Overall Survival (OS)|Overall survival is defined as the time from study enrollment until death.|3.5 years|||months||95% Confidence Interval|Median
37348|NCT01488487|Secondary|Number of Individuals Experiencing Toxicity|Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).|3.5 years|||participants|||Number
37544|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
37349|NCT01488487|Primary|Time to Progression (TTP)|Time to progression is defined as the time from study enrollment until radiological progression in a previously embolized lobe, development of new lesions in an untreated lobe, or evidence of extrahepatic progression (based on modified Hepatocellular Carcinoma (HCC) Response Evaluation Criteria In Solid Tumors (RECIST) criteria). Patients will be followed until death. Patients that die of causes unrelated to the study drug without evidence of progression will be censored.|3.5 years|||months||95% Confidence Interval|Median
37350|NCT01488448|Primary|Length of Stay in the Study-LOS by Per Protocol Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Per protocol analysis (only includes participants who completed the study)||Days||Inter-Quartile Range|Median
37351|NCT01488448|Post-Hoc|LOS Analysis for Patients Whose Study Entry Respiratory Distress Assessment Instrument (RDAI) Was Greater Than or Equal to 4 or Who Had Hypoxia <92%||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of patients who had a study entry Respiratory Distress Assessment Instrument (RDAI) of greater than or equal to 4 points OR hypoxia <92% on admission||days||Inter-Quartile Range|Median
37352|NCT01488448|Post-Hoc|LOS Subgroup Analysis of Patients With a History of Prematurity||through hospitalization/while receiving study medication, average 2-3 days|Patients who reported a history of prematurity/whose Gestational age was <37 weeks||days||Inter-Quartile Range|Median
37353|NCT01488448|Post-Hoc|LOS in Patients With a History of Previous Wheeze||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of the study population who reported a history of wheezing prior to this admission||days||Inter-Quartile Range|Median
37354|NCT01488448|Post-Hoc|LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)||through hospitalization/while receiving study medication, average 2-3 days|This is the population in the study whose RSV testing was positive.||days||Inter-Quartile Range|Median
37355|NCT01488448|Secondary|Total Adverse Events|Clinical worsening events (defined prior) + 7 day readmissions|Time of enrollment in the study through 1 week after hospital discharge|||adverse events|||Number
37356|NCT01488448|Secondary|Clinical Worsening|transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment|though hospitalization/time period receiving study treatment, average 2-3 days|all patients enrolled in the study were analyzed for events related to clinical worsening||participants|||Number
37357|NCT01488448|Secondary|Readmission for Bronchiolitis Within 7 Days of Discharge|Phone call at 7 days to assess for readmission to any hospital|within 7 days of hospital discharge|This population is those who completed the study.||participants|||Number
37358|NCT01488448|Primary|Length of Stay in the Study-LOS--Intention to Treat Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Intention to Treat Analysis||Days||Inter-Quartile Range|Median
37359|NCT01488409|Secondary|Change From Baseline in Lipid Profile at 6-months|Change in direct low density lipoprotein (LDL) cholesterol is given|Change from Baseline to 6-months|all available data used||mg/dL||Standard Deviation|Mean
37360|NCT01488409|Secondary|Change From Baseline in Intramyocellular Lipid Content at 6-months|Change in tibialis intramyocellular lipid (IMCL) normalized to creatinine is given.|Change from Baseline to 6-months|all available data used||ratio of IMCL peak to Creatinine peak||Standard Deviation|Mean
37361|NCT01488409|Secondary|Change From Baseline in Mitochondrial Density at 6 Months|Muscle tissue obtained from biopsy will be used to assess mitochondrial number and morphology by microscopes at Baseline and at 6-months. The change in mitochondrial density from 6 months to baseline is given.|Change from Baseline to 6-months|all available data used||percentage of total muscle fiber area||Standard Deviation|Mean
37362|NCT01488409|Secondary|Change From Baseline in Insulin Sensitivity at 6-months|Change in insulin resistance assessed by hyperinsulinemic-euglycemic clamp study at Baseline and at 6-months. Change in insulin-stimulated glucose uptake (M) during 40 mU/m2/min insulin clamp is given.|Change from Baseline to 6-months visit|all available data used||mg/kg/min||Standard Deviation|Mean
37363|NCT01488409|Primary|Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months|The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.|Change from Baseline to 6-months Visit|all available data used||mM/s||Standard Deviation|Mean
37364|NCT01488188|Secondary|Cell Mediated Immune Responses|Interferon gamma production in peripheral blood monocyte (PBMC) after in vitro re-stimulation with influenza virus antigen at 21 days after vaccination.|21 days after vaccination|||pg/ml||Full Range|Median
37365|NCT01488188|Secondary|Salivary IgA|Salivary Flu-specific IgA titer at Days 21 after vaccination|21 days after vaccination|||Titer||Full Range|Median
37366|NCT01488188|Secondary|Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus|Flu virus-specific IgG- and IgA -antibody secreting cells per ml of blood at 7 days after vaccination|7 days after vaccination|||cells/ml||Full Range|Median
37367|NCT01488188|Primary|Passive Haemagglutination Inhibition Titer.|Passive haemagglutination inhibition titer of serum at 21 days after vaccination.|21 days after vaccination|||Titer||Full Range|Median
37368|NCT01488097|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) Change From Baseline||From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the FAS for whom hs-CRP data were available at both baseline and the indicated timepoint||change from baseline in mg/dL||Standard Deviation|Mean
37369|NCT01488097|Secondary|Serum Ferritin Change From Baseline||From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the FAS for whom serum ferritin data were available at both baseline and the indicated timepoint||change from baseline in µg/L||Standard Deviation|Mean
37370|NCT01488097|Secondary|Lipid Changes From Baseline|Change from baseline in total cholesterol (Total-C), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), and triglycerides (TG).|From baseline (study LAL-CL01) to week 10 or 12, week 24, week 52, week 104|Subjects in the FAS for whom lipid data were available at both baseline and the indicated timepoint||change from baseline in mg/dL||Standard Deviation|Mean
37371|NCT01488097|Primary|ALT and AST Changes From Baseline|Changes from baseline (study LAL-CL01) to specific post-treatment time points in study LAL-CL04 for alanine aminotransferase (ALT) and aspartate aminotransferase (AST).|From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the Full Analysis Set (FAS) for whom ALT and AST data were available at both baseline (study LAL-CL01) and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||Change from baseline in U/L||Standard Deviation|Mean
37372|NCT01488097|Secondary|GGT and ALP Changes From Baseline|Changes from baseline (study LAL-CL01) to specific post-treatment time points in study LAL-CL04 for gamma glutamyltransferase (GGT) and alkaline phosphatase (ALP).|From baseline (study LAL-CL01) to week 12, week 24, week 52, and week 104|Subjects in the Full Analysis Set (FAS) for whom GGT and ALP data were available at both baseline and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||Change from baseline in U/L||Standard Deviation|Mean
37373|NCT01488097|Secondary|Change From Baseline in Liver Fat Content|Percentage change in liver fat content from the LAL-CL04 baseline to the indicated post-treatment time point in study LAL-CL04, as assessed by multi-echo gradient-echo MRI|From baseline (study LAL-CL04) to week 10 or 12, week 24, week 52, week 104|Subjects in the full analysis set (FAS) for whom liver content data were available at both baseline (study LAL-CL04) and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||percentage change from baseline||Standard Deviation|Mean
37374|NCT01488097|Secondary|Change From Baseline in Liver Volume|Change in liver volume (in multiples of normal [MN]) from the LAL-CL04 baseline to the indicated post-treatment time point in study LAL-CL04, as assessed by MRI|From baseline (study LAL-CL04) to week 10 or 12, week 24, week 52, week 104|Subjects in the Full Analysis Set (FAS) for whom liver volume data were available at both baseline (study LAL-CL04) and the indicated post-treatment time point in study LAL-CL04. The FAS included all subjects who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.||change from baseline in MN||Standard Deviation|Mean
37375|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
37376|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 8|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
37377|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)||Week 12|FAS, LOCF||percentage of participants|||Number
37378|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF||percentage of participants|||Number
37379|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 12|FAS, LOCF||percentage of participants|||Number
37380|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 8|FAS, last observation carried forward (LOCF)||percentage of participants|||Number
37381|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 12||Week 12|FAS||units on a scale||Standard Error|Mean
37382|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. Higher score = more affected.|Week 8|FAS||units on a scale||Standard Error|Mean
37383|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
37384|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 8|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
37385|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
37386|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 8|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
37387|NCT01488071|Secondary|Change From Baseline in MADRS Total Score at Week 12||Baseline and Week 12|FAS||units on a scale||Standard Error|Mean
37388|NCT01488071|Primary|Change From Baseline in MADRS Total Score at Week 8|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|full-analysis set (FAS)||units on a scale||Standard Error|Mean
37389|NCT01487954|Secondary|Change in Urine pH|A paired sample t-test (a=0.05) assessing change in urine pH between before treatment day 0 and after radiation and alkaline water treatment day 33.|at baseline and at week 5 (day 33)|Only the first ten patients in the alkaline water group, who took part in the safety lead-in portion of the study were analyzed for urine pH||units on pH scale||Standard Deviation|Mean
37390|NCT01487954|Primary|Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen. Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment. Observed toxicity differences among the treatment arms may be reported in frequency tables.|at 1 month after treatment|||percentage of participants|||Number
37391|NCT01487668|Secondary|Improved Mental Health-related Quality of Life|Change in SF-12 mental health scores from baseline to 12 months. The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months|||units on a scale||Standard Deviation|Mean
37392|NCT01487668|Primary|Physical Health-related Quality of Life|The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months|||units on a scale||Standard Deviation|Mean
37393|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Steady State Concentration to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, steady-state concentrations.|100 days|||mcg/mL||Full Range|Median
37394|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Clearance to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, clearance.|100 days|||mL/min/kg||Full Range|Median
37395|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF AUC to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, area under the plasma concentration versus time curve (AUC).|100 days|||mcg*hr/mL||Full Range|Median
37396|NCT01487577|Secondary|Number of Participants in Overall Survival.||1 year|||participants|||Number
37397|NCT01487577|Secondary|Number of Participants Who Experienced Nonrelapse Mortality.||1 year|||participants|||Number
37398|NCT01487577|Secondary|Number of Participants Who Experienced Relapse.||1 year|||participants|||Number
37399|NCT01487577|Secondary|Number of Participants With Neutrophil and Platelet Engraftment.|Neutrophil and platelet engraftment definitions as defined by the CIBMTR Data Management Manual.|100 days|||participants|||Number
37400|NCT01487577|Primary|Number of Participants With Acute Grade II-IV GVHD, Acute Grade III-IV GVHD, and Chronic GVHD.|Acute GVHD will be graded according to the Modified Glucksberg Staging Criteria. Chronic GVHD will be graded according to NIH Chronic GVHD Consensus Guidelines.|1 year|||participants|||Number
37401|NCT01487577|Primary|Number of Participants With Grade ≥3 Toxicities Scored According to the CTCAE Version 4.0.||100 days|||participants|||Number
37402|NCT01487525|Secondary|Knee Pain|Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire Pain Sub-Scale (0-100); larger absolute values represent less pain; a positive % changes indicates a reduction in pain|0, 6 weeks|||Percent change||Standard Deviation|Mean
37403|NCT01487525|Secondary|Isokinetic Knee Extensor Strength||0, 6 weeks|||percent change||Standard Error|Mean
37404|NCT01487525|Primary|Change in Isotonic Leg Press 1RM|double leg press 1 rep maximum strength|0,6 weeks|||percent change||Standard Deviation|Mean
37405|NCT01487499|Secondary|Overall Survival|Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.|5 years||||||
37406|NCT01487499|Secondary|Progression-free Survival||18 months||||||
37407|NCT01487499|Primary|Solid Tumor Growth After Completion of Interventional Bronchoscopies|The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.|18 months|No participants were analyzed because total enrollment numbers were too low to meet any statistical analysis.|||||
37408|NCT01486966|Secondary|Incidence of Hypoglycaemic Episodes|"All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.~Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl).~A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal."|Weeks 0-2|Safety analysis set included all subjects receiving at least one dose of the trial products.||events|||Number
37409|NCT01486966|Secondary|Change From Baseline in Fructosamine After Two Weeks of Treatment||Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||Umol/L||Standard Error|Least Squares Mean
37410|NCT01486966|Secondary|Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment|FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.||percentage (%) of subjects|||Number
37414|NCT01486966|Secondary|Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment|The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
37415|NCT01486966|Secondary|Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment|The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
37416|NCT01486966|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment|The FPG referred to pre-breakfast plasma glucose.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
37417|NCT01486966|Primary|Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment|Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.||mmol/L||Standard Error|Least Squares Mean
37418|NCT01486927|Other Pre-specified|AUC0-∞ (Part 3)|AUC0-∞ (AUC from 0 extrapolated to infinity) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion|||IU*h/dL||Standard Deviation|Mean
37419|NCT01486927|Other Pre-specified|Cmax (Part 3)|Cmax of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion|||IU/dL||Standard Deviation|Mean
37420|NCT01486927|Other Pre-specified|Tmax (Part 3)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after an initial and repeat infusion of rVIII-SingleChain.|Before infusion and at up to 12 time points within 96 hours of infusion.|||hours||Full Range|Median
37421|NCT01486927|Other Pre-specified|Half-life (t1/2) (Part 3)|Half-life (t1/2) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||hours||Standard Deviation|Mean
37422|NCT01486927|Other Pre-specified|Mean Residence Time (MRT) (Part 3)|Mean residence time (MRT) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||hours||Standard Deviation|Mean
37423|NCT01486927|Other Pre-specified|Clearance (Cl) (Part 3)|Clearance (Cl) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||mL/h/kg||Standard Deviation|Mean
37424|NCT01486927|Other Pre-specified|Volume of Distribution at Steady-state (Vss) (Part 3)|Volume of distribution at steady-state (Vss) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.|||mL/kg||Standard Deviation|Mean
37425|NCT01486927|Other Pre-specified|Incremental Recovery (Part 3)|Incremental recovery of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|At 30 minutes after infusion|||[IU/dL]/[IU/kg]||Standard Deviation|Mean
37426|NCT01486927|Secondary|Proportion of Bleeding Episodes Requiring 1, 2, 3 or > 3 Infusions of rVIII-SingleChain to Achieve Hemostasis|Percentage of bleeding episodes requiring 1, 2, 3 or > 3 infusions of rVIII-SingleChain to achieve hemostasis. The denominator includes all treated bleeding episodes.|During the study (up to 24 months; assessed at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24)|||Percentage of bleeding episodes|Participants||Number
37427|NCT01486927|Secondary|Annualized Bleeding Rate for Total Bleeds and Traumatic Bleeds|The annualized bleeding rate was derived for each subject as follows: 365.25*(number of bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months|||Number of bleeds per year||Inter-Quartile Range|Median
37428|NCT01486927|Secondary|Incremental Recovery (Part 1)|Incremental recovery of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|At 30 minutes after infusion|||[IU/dL]/[IU/kg]||Standard Deviation|Mean
37429|NCT01486927|Secondary|Volume of Distribution at Steady-state (Vss) (Part 1)|Volume of distribution at steady-state (Vss) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||mL/kg||Standard Deviation|Mean
37430|NCT01486927|Secondary|Clearance (Cl) (Part 1)|Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||mL/h/kg||Standard Deviation|Mean
37431|NCT01486927|Secondary|Mean Residence Time (MRT) (Part 1)|Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion|||hours||Standard Deviation|Mean
37432|NCT01486927|Secondary|Half-life (t1/2) (Part 1)|Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion.|||hours||Standard Deviation|Mean
37433|NCT01486927|Secondary|Tmax (Part 1)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain.|Before infusion and at up to 10 time points within 72 hours of infusion|||hours||Full Range|Median
37435|NCT01486927|Secondary|AUC0-∞ (Part 1)|AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion|||IU*h/dL||Standard Deviation|Mean
37436|NCT01486927|Primary|Treatment Success During the Peri-operative Surgical Sub-study|"Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator."|From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)|||% of surgeries with successful treatment|||Number
37437|NCT01486927|Primary|Annualized Spontaneous Bleeding Rate|The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months|||Number of spontaneous bleeds per year||Inter-Quartile Range|Median
37438|NCT01486927|Primary|Inhibitor Formation to FVIII|Number of subjects who develop inhibitors to FVIII|Up to 24 months|||participants|||Number
37439|NCT01486927|Primary|Treatment Success|"The investigator rated the efficacy of the treatment based on a 4-point rating scale excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation."|Up to 24 months|||% bleeding events successfully treated|Participants|95% Confidence Interval|Number
37440|NCT01486615|Secondary|Number of Patients With Loss of Memory for Being Transferred to Operating Room.|Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.|24 hour after surgery|||Participants|||Number
37441|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at one hour after premedication|||Centimeter||Standard Deviation|Mean
37442|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at 30 minutes after premedication|||centimeter||Standard Deviation|Mean
37443|NCT01486615|Secondary|Amount of Propofol Consumption|Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.|1 - 2 hour after premedication|||mg||Standard Deviation|Mean
37444|NCT01486615|Secondary|Number of Patients With Intact Memory|Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.|24 hour after surgery|||Participants|||Number
37445|NCT01486615|Secondary|Orientation Score|Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.|Orientation score at one hour after premedication|||units on a scale||Inter-Quartile Range|Median
37446|NCT01486615|Secondary|Sedation Score at One Hour After Premedication|Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.|Sedation score at 1 hour after the premedication|||units on a scale||Inter-Quartile Range|Median
37447|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Change from baseline in VAS anxiety score at 15 minutes after premedication|sample size of 16 patients in each group was determined by a power analysis (α, 0.05; β, 0.10) assuming that there will be 50% reduction in anxiety VAS from baseline in the experimental groups and 4% in the placebo group. To compensate for dropout cases and shifting from normality in data distribution, 20 cases were studied in each group.||Centimeter||Standard Deviation|Mean
37448|NCT01486446|Other Pre-specified|Sleep Interference Due to Pain in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded sleep interference scores in their diary cards for each night (scores were recorded upon waking).~Sleep Interference due to pain is scored using an 11 point numerical rating scale where 0 = pain does not interfere with sleep and 10 = completely interferes, unable to sleep due to pain.~A lower sleep interference score compared to Baseline indicates that the subjects' pain interfered with sleep less on treatment than during Baseline."|Baseline to 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
37449|NCT01486446|Other Pre-specified|Daily Pain (Maximum Pain Intensity) in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded pain scores in their diary cards 3 times each day (upon waking, lunchtime and evening).~On each recording occasion, subjects recorded the maximum pain experienced since the previous recording occasion using an 11 point numerical rating scale of pain intensity, PINRS (where 0 = no pain and 10 = worst pain imaginable).~A lower score compared to Baseline indicates that the subjects experienced less severe pain on treatment than during Baseline."|Baseline to 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
37450|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.~A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.~A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
37451|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.~A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.~A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5|||Percentage of Baseline||Inter-Quartile Range|Mean
37452|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.~A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days|||Percentage of Baseline||Inter-Quartile Range|Mean
37453|NCT01486446|Primary|Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2.~A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days|||cooling uses/day||Inter-Quartile Range|Mean
37454|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.~A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5|||Percentage of Baseline||Inter-Quartile Range|Mean
37455|NCT01486446|Other Pre-specified|Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use and duration of all non-pharmacological cooling methods used to relieve their EM pain each day during Treatment Period 2.~A smaller average duration of cooling each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days|||minutes/day||Inter-Quartile Range|Mean
37456|NCT01486238|Secondary|Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.|"There is a possibility that some subjects may not respond to the study treatment to which they have been assigned. Macular laser treatment is considered an alternative treatment for retinal edema. A lower proportion of subjects requiring macular laser treatment would indicate a superior treatment regimen.~This will be assessed at week 12, and again at week 24."|24 weeks||||||
37457|NCT01486238|Secondary|Mean Change From Baseline at Week 24 in Central Foveal Thickness|Optical Coherence Tomography (OCT) will be used to assess the central foveal thickness of each patient. The mean change from baseline to week 24 will be calculated for each patient.|24 Weeks||||||
37528|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in PGAA|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.|Day 43 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
37458|NCT01486238|Primary|Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.|The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score in the Study Eye compared with baseline at 24 weeks. The BCVA is to be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.|24 weeks|Proportion of subjects who gain two or more lines BCVA was calculated.||participants|||Number
37459|NCT01486043|Secondary|Hemoglobin A1c||At 1 month|||percent of hemoglobin||Full Range|Mean
37460|NCT01486043|Secondary|Serum Fructosamine Level||At 1 month|||uM||Full Range|Mean
37461|NCT01486043|Primary|Length of Insulin Therapy (Days)||During the 30 days of induction chemotherapy (plus or minus 2 weeks)|||days||Full Range|Mean
37462|NCT01485991|Secondary|Percentage of Participants With Viral Relapse|Participants are considered to have a viral relapse if both conditions as specified are met: 1) <25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (>=) 25 IU/mL during follow-up.|End of Treatment (Week 48) up to Follow-up Period (until Week 72)|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
37463|NCT01485991|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than <25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable (24 weeks after the planned EOT).|24 Weeks After the Planned EOT (Week 48)|ITT population included all randomized participants who took at least 1 dose of study medication.||percentage of participants|||Number
37464|NCT01485991|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable.|12 Weeks After the Planned End of Treatment (EOT: Week 48)|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication.||percentage of participants|||Number
37465|NCT01485887|Secondary|Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score and QIDS16-SR-J score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
37466|NCT01485887|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
37467|NCT01485887|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
37468|NCT01485887|Secondary|Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.||Units on a scale||Standard Deviation|Mean
37488|NCT01485172|Secondary|Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Participants|||Number
37469|NCT01485887|Primary|Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.||Participants|||Number
37470|NCT01485887|Primary|Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes|Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)> 450 millisecond (ms), >480 ms, and >500 ms respsctively, change from baseline in QTc, QTcB, and QTcF >= 30 ms, and >= 60 ms, respectively.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the electrocardiogram while on study treatment.||Participants|||Number
37471|NCT01485887|Primary|Number of Participants With Clinical Significant Laboratory Tests Changes|Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count <0.8 x lower limit normal (LLN); Lymphocytes (%) <0.8 x LLN; Eosinophils (%) >1.2 x upper limit normal (ULN); Total Bilirubin >1.5 x ULN; Alanine Aminotransferase (ALT) >3.0 x ULN; Gamma glutamyl transferase (GGT) >3.0 x ULN; Uric Acid >1.2 x ULN; Cholesterol >1.3 x ULN; Low density lipoprotein (LDL) cholesterol >1.2 x ULN; Triglycerides >1.3 x ULN; Glucose >1.5 x ULN; Urine Glucose [qualitative (Qual)] >=1; Urine Protein (Qual) >=1; Urine Blood/Hemoglobin (Hgb) (Qual) >=1.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the given laboratory test while on study treatment or during lag time.||Participants|||Number
37472|NCT01485887|Primary|Number of Participants With Clinical Significant Vital Changes|Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP >= 90 mmHg with change from the baseline >= 10 mmHg; SBP >= 140 mmHg with change from the baseline >= 20 mmHg; PR >= 100 bpm with change from the baseline >= 15 bpm.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.||Participants|||Number
37473|NCT01485887|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who recieved at least one dose of the study drug.||Participants|||Number
37474|NCT01485640|Secondary|Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|18 months|Only 153 subjects who had baseline and at least one post-baseline assessments.||units on a scale||Standard Deviation|Mean
37475|NCT01485640|Primary|Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs|Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.|18 months|Safety Population - subjects who took at least one dose of study medication||participants|||Number
37476|NCT01485536|Primary|Overall Response Rate (ORR)|Percentage of participants with objective response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|Up to 12 cycles or 48 weeks|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis||percentage of participants|||Number
37477|NCT01485536|Primary|Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL)|Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|56 days|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis||Participants|||Count of Participants
37478|NCT01485380|Primary|Number of Participants With Changes in the Brains Default Mode Network.|Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states.|1.5hrs|All 17 participants were analyzed. Blood oxygen level depended (BOLD) signals during the awake (n = 16), unconscious (n = 16), and recovery (n = 15) states were included in the final data set.||participants|||Number
37479|NCT01485172|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.|Up to Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Percentage of participants|||Number
37511|NCT01484912|Secondary|Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).|Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.|baseline (visit 2) through week 6 (visit 5)|||seconds||Standard Deviation|Mean
37480|NCT01485172|Secondary|Responder Rate According to the Clinical Global Impression – Global Improvement (CGI-I) Scale|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Percentage of participants|||Number
37481|NCT01485172|Secondary|Change From Baseline in the UPDRS Part I (Mentation)|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the on phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Score on a scale||95% Confidence Interval|Least Squares Mean
37482|NCT01485172|Secondary|Change From Baseline in the Total UPDRS Score (Parts I-III)|"The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Score on a scale||95% Confidence Interval|Least Squares Mean
37483|NCT01485172|Secondary|Change From Baseline in UPDRS Activities of Daily Living|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Score on a scale||95% Confidence Interval|Least Squares Mean
37484|NCT01485172|Secondary|Change From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Scores on a scale||95% Confidence Interval|Least Squares Mean
37485|NCT01485172|Secondary|Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score|The responder rate is defined as the percentage of participants with a greater than or equal to (>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Percentage of Participants|||Number
37486|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Participants|||Number
37487|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed||Participants|||Number
39470|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 3 (week 2)||||||
37489|NCT01485172|Primary|Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III – Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).|Baseline and Week 4 of the Maintenance Period (Study Week 17)|Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment.||Score on a scale||95% Confidence Interval|Least Squares Mean
37490|NCT01485094|Secondary|Daily Current Pain Intensity|"Participants recorded their current pain intensity score 3 times a day, using a 0 -10 (11 point) Numeric Rating Scale where a rating of 0 corresponded to No Pain and a rating of 10 to Pain as bad as you can imagine.~The daily current pain intensity reported was derived as the mean of the 3 current pain intensity assessments taken on the day from all participants in the treatment group.~The lower the value on the 11 point scale the less pain was reported on a treatment."|Baseline; Day 10|Intent-to-Treat.||units on a scale||Standard Deviation|Mean
37491|NCT01485094|Secondary|Change in painDETECT Grading From Baseline (Day -1) to End of Double-blind Treatment (Day 7)|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated between 0 and 38 for each participant. Participants with a score between 0 and 12 are graded as negative and having no neuropathic pain component. Scores between 19 and 38 result in a positive grading, in other words having presence of neuropathic component. Values from 13 to 18 result in participants being graded as having an unclear neuropathic component to their pain. The painDETECT questionnaire was first administered on Day-1 (baseline). The data reported is for before treatment start (Day -1) and the change from baseline on Day 7 (end of the double-blind period)."|Day 7 (end of double blind treatment)|Intent-to-treat. 5 participants did not complete the painDETECT questionnaire on Day 7. Two participants in both the placebo and pregabalin treatment arm and 1 in the GRT6010 treatment arm.||participants|||Number
37492|NCT01485094|Secondary|Difference in Leeds Sleep Evaluation Questionnaire After 7 Days of Treatment|"On the last day of the double-blind treatment period sleep was evaluated using the Leeds sleep evaluation questionnaire. This questionnaire has 10 self-rating 100 mm line analogue questions concerning sleep and early morning behavior. The higher the score, i.e. the closer the value is to 100 the worse the rating by the participant.~The 10 responses are grouped into 4 subscores:~The ease of getting to sleep.~The perceived quality of sleep.~The ease of awakening from sleep.~The integrity of behavior following wakefulness."|Day 7|Intention-to-treat. No responses were obtained from 2 participants, one in the placebo and one in the pregabalin treatment arm.||units on a scale||Standard Deviation|Mean
37493|NCT01485094|Secondary|Change in Area of Static Allodynia and Dynamic Allodynia From Baseline|"Allodynia is pain due to a stimulus that does not normally provoke pain. To measure the areas of dynamic and static allodynia, a point lying in the center of the area of maximum pain was marked at baseline (Day -2 and -1). From the baseline point, 8 radii were drawn.~The area of dynamic allodynia was determined by gently stroking the skin with a standardized brush along the lines. The participant was asked to report when the sensation became unpleasant.~The area of static allodynia was determined by a 128 mN (millinewton) pinprick stimulus along the lines of the 8 radii while asking the subject to report when the sensation became unpleasant.~The area was calculated from the summing of the 8 triangles that are generated from the points along each of the 8 radii at which unpleasantness was reported. The larger the area in square centimeters the more allodynia. A reduction in the area of allodynia indicates improvement."|Baseline; Day 7 (end of double blind treatment)|Intent-to-treat||square centimeters||Standard Deviation|Mean
37494|NCT01485094|Secondary|The Difference Between Baseline and End-of-double-blind Treatment Scores for Dynamic Mechanical Allodynia and Mechanical Pain Sensitivity Compared to Placebo|"Allodynia is pain due to a stimulus that does not normally provoke pain. Dynamic mechanical allodynia was assessed using a set of 3 light tactile stimulators as moving innocuous stimuli.~Each participant gave numerical pain ratings for each of 15 stimuli at the affected side.~Mechanical pain sensitivity was assessed using a set of 7 weighted pinprick stimuli to obtain the stimulus–response function for pinprick-evoked pain.~The participant gave a numerical pain ratings for each of 35 pinprick stimuli at the affected site.~Dynamic mechanical allodynia and mechanical pain sensitivity was calculated as the geometric mean of all numerical ratings. The values obtained on Day -2 and -1 were taken as the baseline and values on Day 6 and 7 were taken as the end of treatment. A negative change indicates an improvement on the 0 (no pain) to 100 point scale, where 100 indicates the worst imaginable pain."|Day 7 (end of double blind treatment)|Intention-to-treat||units on a scale||Standard Deviation|Mean
37495|NCT01485094|Secondary|Difference in Patient's Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the 7 day treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Day 7 (end of double blind treatment)|Intention-to-treat||participants|||Number
37506|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.||Percentage of corneal staining||Standard Deviation|Mean
37507|NCT01484912|Secondary|Consumption of Short-acting Nitrates||The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|The data was not available for analysis, because only two patients administered short-acting nitrates||mg||Standard Deviation|Mean
37496|NCT01485094|Secondary|Change in Neuropathic Pain Symptom Inventory Scores on Day 7 From Baseline (Day -1)|"The Neuropathic Pain Symptom Inventory (NPSI) Score is an assessment of neuropathic pain symptoms.~A participant answered 10 questions on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable).~The total NPSI score is the sum of all ten responses and ranges between 0 and 100.~The baseline score and the mean NPSI change is reported over the double-blind treatment period. A negative mean change in score on Day 7 indicates an improvement on this 0 to 100 point scale from baseline for the total score.~For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores a negative mean change indicate an improvement on the 11 point scale. A participant will score 10 to indicates the worst imaginable symptom, e.g. worst burning imaginable. A participant will score 0 if there is no burning, i.e. the symptom is absent."|Day -1; Day 7 (end of double blind treatment)|intent-to-treat||units on a scale||Standard Deviation|Mean
37497|NCT01485094|Secondary|Onset of Ongoing Pain Relief|"Onset of ongoing pain relief defined as the first time-point at which the participant reports a decrease of more than 1-point reduction in ongoing pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1. Study drug intake started on Day 1.~Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)||||||
37498|NCT01485094|Secondary|Onset of Current Pain Relief|"Onset of current pain relief defined as the first time-point at which the participant reports a decrease of a 1-point reduction in current pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1.~Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)||||||
37499|NCT01485094|Secondary|Assessment of Responder Rates|"The assessment was performed on Day 7.~The percentage of change from baseline (Day -3 to Day -1, i.e. the 3 days in the days prior to first dose) in the daily ongoing pain intensity was calculated at Day 7.~The percentage of change from baseline in the daily ongoing pain intensity was calculated at Day 7 as follows:~% change = (Baseline Pain Intensity - Daily pain intensity at treatment visit) / Baseline Pain Intensity × 100~The threshold values represent an improvement in ongoing pain intensity greater than 20, 30, 40, 50, 60, 70, 80 or 90% as per calculation.~Participants who showed a worsening in their daily pain intensity or who prematurely discontinued the trial were regarded as non-responders in terms of the respective treatment."|Day 7 (end of double blind treatment)|||participants|||Number
37500|NCT01485094|Primary|The Difference Between Baseline and End-of-double-blind Treatment Brush-evoked Pain Intensity Scores|"The difference between baseline and end-of-double-blind treatment brush-evoked pain intensity scores compared to placebo on a 0-100 point NRS (measured as part of the dynamic mechanical allodynia assessments).~Each participant rated each brush-evoked pain intensity on a 0 to 100 point Numerical Pain Rating Scale, with 0 indicating ‘No Pain’ and 100 indicating ‘most intense pain imaginable’. Lower values compared to an individual subject’s baseline are an improvement in symptoms.~The baseline brush-evoked pain intensity score was defined as the average of the geometric mean of all of the values obtained on Day -2 and Day -1, and compared with the scores obtained on day 6 and 7.~For the analysis, only pain scores on days where participants received study drug were considered.~A negative change indicates a decrease in brush-evoked pain intensity from baseline."|Baseline and day 7 (end of double blind treatment)|||units on a scale||Standard Deviation|Mean
37501|NCT01485094|Primary|Difference Between Baseline and End-of-double-blind Treatment Ongoing Pain Intensity Scores|The baseline pain intensity score was calculated as a mean of pain intensity scores during the Baseline Period (from Day -3 to Day -1). The ongoing pain intensity data from Day-3 to Day 7 was used. For the analysis, only pain scores on days where participants received study drug were considered. The primary efficacy analysis of the ongoing pain intensity score were analyzed in a Bayesian framework, via a mono exponential decay model, with the baseline Numeric Rating Score (NRS) as intercept. Considering the inclusion criteria of baseline pain intensity being in the range from 4 to 9, the range in ongoing pain intensity difference between baseline and end-of-double-blind treatment can be from 6 (worst possible value) to -9 (best possible value). A negative value indicates improvement whilst on the treatment.|Baseline; Day 7 (end of double blind treatment)|Intention-to-treat||units on a scale||Standard Deviation|Mean
37502|NCT01484977|Primary|Retention at the End of the 21-week Treatment Period|Retention is a summary measure that integrates both the patient’s and clinician’s assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.|Duration of the Treatment Period (21 Weeks)|The primary analysis consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.||percentage of participants|||Number
37503|NCT01484951|Secondary|Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy|As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.|Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.||Percentage of Participants|||Number
37504|NCT01484951|Primary|Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)|As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.|Baseline, Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.||millimeters mercury (mmHg)||Standard Deviation|Mean
37505|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.||Units on a scale||Standard Deviation|Mean
37508|NCT01484912|Secondary|Change in Pharmacological Parameters|The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.|baseline (visit 2) to week 6 (visit 5)||||||
37512|NCT01484912|Primary|Change in Total Exercise Time|Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.|baseline (visit 2) and week 6 (visit 5)|||seconds||Standard Deviation|Mean
37513|NCT01484873|Secondary|Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)|Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks|baseline, 50 weeks|||minutes||95% Confidence Interval|Mean
37514|NCT01484873|Secondary|Insulin Secretion (Area Under the Curve)|Change in insulin secretion from baseline|baseline, 50 weeks|||120 min*uU/mL x||95% Confidence Interval|Mean
37515|NCT01484873|Secondary|Visual Analogue Scales for Post-meal Satiety|Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).|baseline, 50 weeks|||mm||95% Confidence Interval|Mean
37516|NCT01484873|Secondary|Resting Energy Expenditure (Kcals Per Day)|Change in resting energy expenditure from baseline to 50 weeks|baseline, 50 weeks|8 patients completed the study but one patient did not have REE data available due to technical difficulties||kcal/day||95% Confidence Interval|Mean
37517|NCT01484873|Primary|Body Weight (kg)|Change in body weight from baseline to end of study|baseline, 50 weeks|Patients that completed the study||kg||95% Confidence Interval|Mean
37518|NCT01484652|Primary|SPID48 (Summed Pain Intensity Difference)|Pain intensity (PI) is measured using the 11-point (0-10) Numeric Pain Rating Scale (NPRS) score. PID is the arithmetic difference in NPRS score at the time point of interest from the baseline score. SPID48 is the sum of time-weighted PID scores measured 22 times over the 48 hour assessment period, with a total score ranging from -480 (worst) to 480 (best). A higher SPID value indicates greater pain relief.|48 hours|The analysis population for the primary outcome measure was the modified intent-to-treat population (mITT). The mITT analysis population includes 303 subjects from Cohort 2. Missing pain intensity difference scores were imputed using a multiple imputation method.||scores on a scale||Standard Error|Mean
37519|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 43 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
37520|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
37521|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 43 of Period 1|FAS||score on a scale||Standard Error|Least Squares Mean
37522|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 43 of Period 2, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
37523|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
37524|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 43 of Period 1|FAS||mm||Standard Error|Least Squares Mean
37525|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 43 of Period 1, Day 29 of Period 1|FAS||mm||Standard Error|Least Squares Mean
37526|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
37527|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 43 of Period 1|FAS||mm||Standard Error|Least Squares Mean
37529|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in PGAA|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.|Day 1 of Period 1, Day 29 of Period 2|FAS||mm||Standard Error|Least Squares Mean
37530|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly.|Day 1 of Period 1, Day 43 of Period 1|FAS||mm||Standard Error|Least Squares Mean
37531|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in CRP||Day 43 of Period 1, Day 29 of Period 2|FAS||mg/L||Standard Error|Least Squares Mean
37532|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in CRP||Day 1 of Period 1, Day 29 of Period 2|FAS||mg/L||Standard Error|Least Squares Mean
37533|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in CRP||Day 1 of Period 1, Day 43 of Period 1|FAS||mg/L||Standard Error|Least Squares Mean
37534|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS||swollen joints||Standard Error|Least Squares Mean
37535|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS||swollen joints||Standard Error|Least Squares Mean
37536|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS||swollen joints||Standard Error|Least Squares Mean
37537|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS||tender/painful joints||Standard Error|Least Squares Mean
37538|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS||tender/painful joints||Standard Error|Least Squares Mean
37539|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal [IP], PIP, and distal interphalangeals [DIP]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals [MTP], great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS||tender/painful joints||Standard Error|Least Squares Mean
37540|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
37541|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
37542|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS||score on a scale||Standard Error|Least Squares Mean
37543|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS||score on a scale||Standard Error|Least Squares Mean
37545|NCT01484561|Secondary|Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])|DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS||score on a scale||Standard Error|Least Squares Mean
37546|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)||percentage of participants|||Number
37547|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)||percentage of participants|||Number
37548|NCT01484561|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥)20 percent (%) improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS, missing values while participant was still enrolled utilized last observation carried forward (LOCF) imputation while participants with missing values after a participant was discontinued from study participation (for any reason) were considered to be nonresponders (nonresponder imputation [NRI])||percentage of participants|||Number
37549|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in serum creatinine.||fold change||90% Confidence Interval|Geometric Mean
37550|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in serum creatinine.||fold change||90% Confidence Interval|Geometric Mean
37551|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in serum creatinine.||fold change||90% Confidence Interval|Geometric Mean
37552|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (Cockcroft-Gault).||fold change||90% Confidence Interval|Geometric Mean
37553|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (Cockcroft-Gault).||fold change||90% Confidence Interval|Geometric Mean
37554|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (Cockcroft-Gault).||fold change||90% Confidence Interval|Geometric Mean
37555|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS (OC); three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (MDRD).||fold change||90% Confidence Interval|Geometric Mean
37556|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (MDRD).||fold change||90% Confidence Interval|Geometric Mean
37557|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS (OC); one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (MDRD).||fold change||90% Confidence Interval|Geometric Mean
37558|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in mGFR.||fold change||90% Confidence Interval|Geometric Mean
37559|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR.||fold change||90% Confidence Interval|Geometric Mean
37560|NCT01484561|Primary|Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)|Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m^2) body surface area. A normal GFR is greater than (>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the test article (CP-690,550 or placebo). Observed Case (OC): missing data were not imputed. One participant was excluded (took wrong treatment) from FAS analysis of change at end of Period 1 from baseline in mGFR.||fold change||90% Confidence Interval|Geometric Mean
37561|NCT01484314|Secondary|Incidence of Grade 3/4 Thrombocytopenic Events|To assess whether eltrombopag decreases the incidence of grade 3/4 thrombocytopenic events by day 1 of Cycle 3 of chemotherapy|2 years||||||
37562|NCT01484314|Primary|Safety and Tolerability|To determine whether eltrombopag administration results in an increased number of participants with adverse events.|2 years||||||
37563|NCT01484314|Primary|Maintenance of Platelet Count|To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at > 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy|2 years|patient privacy concern due to a one patient accrual|||||
37564|NCT01484197|Secondary|Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)||Day 1, Day 7|PK Analysis Set||hour*pg/mL||Standard Deviation|Mean
37565|NCT01484197|Secondary|Observed Maximum Concentration (Cmax) After Drug Administration||Day 1, Day 7|PK Analysis Set||pg/mL||Standard Deviation|Mean
37566|NCT01484197|Secondary|Time to Reach Maximum Concentration (Tmax) After Drug Administration||Day1, Day 7|PK Analysis Set||Hours||Full Range|Median
37567|NCT01484197|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section|Up to 101 days|Safety population inlcuded all participants who received at least one dose of study drug.||Participants|||Number
37568|NCT01484197|Secondary|Number of Puffs of Rescue Medicine|Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect.|Up to 101 days|Participants in the Pharmacodynamics Analysis set (included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement) who used rescue medication.||Puffs/day||90% Confidence Interval|Least Squares Mean
37569|NCT01484197|Secondary|Peak Expiratory Flow Rate in the Morning in the Evening|PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model.|Up to 101 days|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters per second||Standard Error|Least Squares Mean
37570|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)|Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||90% Confidence Interval|Least Squares Mean
37571|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)|Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||90% Confidence Interval|Least Squares Mean
37572|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters/second||Standard Deviation|Mean
37573|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters/second||Standard Deviation|Mean
37574|NCT01484197|Secondary|FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Ratio||Standard Deviation|Mean
37575|NCT01484197|Secondary|FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Ratio||Standard Deviation|Mean
37576|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
37577|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
37578|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
37579|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement||Liters||Standard Deviation|Mean
37580|NCT01484197|Secondary|Time to Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Hours||Full Range|Median
37581|NCT01484197|Secondary|Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||90% Confidence Interval|Least Squares Mean
37603|NCT01483937|Secondary|Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1|A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)|Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days|||percentage of participants|||Number
37582|NCT01484197|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment|Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||Standard Error|Least Squares Mean
37583|NCT01484197|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment|Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.||Liters||Standard Error|Least Squares Mean
37584|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 15 subjects who had BPA at 14 days after the second dental treatment were used.||ng/mL||Standard Deviation|Mean
37585|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 26 subjects who had BPA at 1 day after the second dental treatment were used.||ng/mL||Standard Deviation|Mean
37586|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 81 subjects who had BPA at 14 days after the first dental treatment were used.||ng/mL||Standard Deviation|Mean
37587|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 89 subjects who had BPA at 1 day after the first dental treatment were used.||ng/mL||Standard Deviation|Mean
37588|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at follow-up minus BPA at baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 6 months|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 77 subjects who had BPA at 6 months were used.||ng/mL||Standard Deviation|Mean
37615|NCT01483924|Secondary|Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|||hour||Full Range|Median
37589|NCT01484054|Primary|Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.||units on a scale||Standard Error|Least Squares Mean
37590|NCT01484054|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.||units on a scale||Standard Error|Least Squares Mean
37591|NCT01484054|Primary|Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.||units on a scale||Standard Error|Least Squares Mean
37592|NCT01484041|Secondary|Progression-free Survival|Length of time from study entry until progressive disease|24 weeks|Data not collected for this outcome as study terminated by company prior to completing accrual|||||
37593|NCT01484041|Secondary|Pharmacodynamic Effects|Expression of pFGFR, pFRS2, pERK in tumor tissue and VEGF, bFGF, PLGF, sVEGFR1/2 and FGF23 levels in plasma|24 weeks|Data were not collected for this outcome|||||
37594|NCT01484041|Secondary|Number of Participants With Adverse Events|Number of participants experiencing adverse events|24 weeks|||participants|||Number
37595|NCT01484041|Secondary|Recommended Phase 2 Dose|The dose of dovitinib at which 1 or less subjects experience a dose limiting toxicity when administered every day for 5 days followed by 2 days off schedule in combination with an aromatase inhibitor|4 weeks|Subjects on study evaluated for toxicity||mg|||Number
37596|NCT01484041|Primary|Clinical Benefit Rate|Complete response, partial response, or stable disease at 24 weeks from trial entry as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|24 weeks|||participants|||Number
37597|NCT01484028|Primary|Corneal Staining of Grade 3 or 4|Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.|After 7-9 days of lens wear|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.||% of Eyes|Participants|95% Confidence Interval|Number
37598|NCT01484028|Primary|Lens Fit Acceptance|The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.||% of Eyes|Participants|95% Confidence Interval|Number
37599|NCT01484028|Primary|Monocular Visual Acuity|Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.||LogMAR score|Participants|Standard Deviation|Mean
37600|NCT01483937|Secondary|Head Shake Sensory Organization Test (HS_SOT)|"Head Shake Sensory Organization Test (HS-SOT)~HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis."|Pre Test, Post Test 1 and Post Test 4||||||
37601|NCT01483937|Secondary|Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4|Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.|Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days|||units on a scale||Standard Deviation|Mean
37602|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2|"Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment.~Scoring: A five-point ordinal scale, ranging from 0-4. “0” indicates the lowest level of function and “4” the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling.~Criterion Validity: “Authors support a cut off score of 45/56 for independent safe ambulation”.~Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 –20 = high fall risk~Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded:~Sensitivity = 64% (Correctly predicts fallers)~Specificity = 90% (Correctly predicts non-fallers)"|Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.|||percentage of participants|||Number
37604|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2|"Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where 0 indicates the lowest level of function and 3 the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling.~Criterion Validity: “Authors support a cut off score of 23/30 for independent safe ambulation”.~Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders.~3) 23-30 = safe ambulators"|Pre Test to Post Test 2 after four physical therapy sessions within 10 days|||percentage of participants|||Number
37605|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)|||units on a scale||Standard Deviation|Mean
37606|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)|||units on a scale||Standard Deviation|Mean
37607|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)|||units on a scale||Standard Deviation|Mean
37608|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Pre Test to Post Test 1 after two physical therapy sessions (one week)|||units on a scale||Standard Deviation|Mean
37609|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score|In the PGA, the physician assigns a single estimate of a patient’s overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
37610|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System–Physician Global Assessment (LS-PGA) Scores|The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51–100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from “none” to “marked”; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
37611|NCT01483924|Secondary|Efficacy of APO805K1 as Assessed by Achievement of PASI-75|The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12|12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||percentage of patients|||Number
37612|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores|PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 Weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
37613|NCT01483924|Secondary|T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14|T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)||hour||Standard Deviation|Mean
37614|NCT01483924|Secondary|AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14|AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)||ng *hr/mL||Standard Deviation|Mean
37691|NCT01482091|Secondary|Presence of Headache||Participants will be followed for the duration of their ED visit, an expected average of 6 hours|||participants|||Number
37616|NCT01483924|Secondary|Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)||ng/mL||Standard Deviation|Mean
37617|NCT01483924|Primary|Number of Patients With Adverse Events|The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.|12 Weeks|The Safety Population consisted of all patients who received at least 1 dose of study medication.||participants|||Number
37618|NCT01483820|Secondary|To Evaluate the Drug Levels and Pharmacokinetics (PK) of TPI 287 From Blood Samples at Multiple Time Points Within the First 24 Hours on Study.|To evaluate the pharmacokinetics (PK) of TPI 287 in the Phase I population of this trial.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
37619|NCT01483820|Secondary|Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|To evaluate the impact of QOL of children receiving TPI287 using PedsQL questionnaires|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.|||||
37620|NCT01483820|Secondary|Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|3 years|Not evaluated due to early closure. Study data does not exist.|||||
37621|NCT01483820|Secondary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years|||Days|||Number
37622|NCT01483820|Secondary|Number of Participants With Overall Response Assessed Using RECIST Criteria|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|||participants|||Number
37623|NCT01483820|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Phase I portion of trial- To determine the safety and tolerability of TPI 287 as a single agent in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma. Adverse events collected from time of first dose to 30 days past last dose and until all related events resolved, average of one year.|length of study +30 days|||participants|||Number
37624|NCT01483651|Primary|Area Under the Curve for Glucose Above Baseline|The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production [mg/kg/min] measured over time [min]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.|60 minutes after each glucagon administration|||mg/kg glucose per mcg glucagon||Standard Deviation|Mean
37625|NCT01483625|Secondary|Weekly Rescue Medication Use Over the 12 Weeks of Study|Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.|12 weeks|TS with non missing rescue medication use.||puffs||Standard Deviation|Mean
37626|NCT01483625|Secondary|Responder Status at Week 12 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:~Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).~Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).~Subject did not recover."|12 weeks|TS with non missing responder data at week 12. Responder defined by >= 20% improvement. .||participants|||Number
37627|NCT01483625|Secondary|Responder Status at Week 4 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:~Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).~Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).~Subject did not recover."|4 weeks|Responder defined by >= 20% improvement. TS with non missing responder data.||participants|||Number
37628|NCT01483625|Secondary|Trough FVC (in Litres) at 12 Weeks|The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|TS with non missing FVC data.||Litres||Standard Deviation|Least Squares Mean
37629|NCT01483625|Secondary|Time to Recovery From Acute Respiratory Symptoms|"Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations.~The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation.~The EXACT-PRO was answered by the patients on a daily basis in the evening."|12 weeks|TS with non missing EXACT-PRO data.||units on a scale||Standard Deviation|Geometric Mean
37630|NCT01483625|Primary|Trough FEV1 After 12 Weeks on Study Drug|The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|Treated Set (TS) with non missing FEV1 data.||Litre||Standard Error|Least Squares Mean
37692|NCT01482091|Secondary|Presence of Bradycardia|Number of participants who had bradycardia|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
37631|NCT01483378|Primary|Answers to Survey Questions|All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.|January 9, 2012 to February 12, 2012|||Percentage of responders||95% Confidence Interval|Number
37632|NCT01483352|Secondary|Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response|The participant questionnaire consisted of two parts including description of routine operations, followed by 23 questions used to determine the following: percentage of participants needing consultation of instructions for use of fixation disc or infusion set; percentage of participants with pain after implantation, percentage of participants with moderate pain during 4 to 6 days after implantation, moderate pain for 7 days or more; percentage of participants with temporal disconnection from infusion set; percentage of participants with use of handling aid for temporal storage; percentage of participants with a reason for temporal disconnection of infusion set from port either sex, shower, or sport; percentage of participants changing fixation disc ≥3 days or infusion set ≥4 days and the cartridge, and percentage of participants cleaning the skin around the port daily, every second day, or every third to fifth day, either with saline during healing or with alcohol after healing.|Week 12|All participants were included in the analysis.||percentage of participants|||Number
37633|NCT01483352|Secondary|Percentage of Participants Achieving Target Glucose Levels|Target glucose values were 70-180 mg/dL. Participants with glucose levels below 70 mg/dL were considered to be under target and those above 180 mg/dL were considered over target. The mean of Glucose-Measurements at the visit date was calculated as follows: a variable was created for each category (“within target [70-180 mg]”, “below target” and “above target”) that tells if the value lies within this category. Then the percentage per participant and visit was calculated. The mean represents the mean of these percentages per participant at the visit.|Screening, Week 12 and 6 Months|All participants were included in the study; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants||Standard Deviation|Mean
37634|NCT01483352|Secondary|Glycemic Variability: Percent Coefficient of Variation in Blood Glucose|Both self monitored (SMBG) and continuous (CGM) glucose measurements were used to determine the coefficient of variation in blood glucose. CGM data are only evaluated for a 1 week time period and are no direct comparison to the SMBG that reflect the full time frame between visits.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percent of mean glucose value||Standard Deviation|Mean
37635|NCT01483352|Secondary|Continuous Glucose Measurement (CGM) - Glucose Levels|CGM measurements were performed using a diurnal CGM sensor and group means were calculated over 10 minute periods of the CGM measurements.|Screening, Week 12 and 6 Months|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||mg/dL||Standard Deviation|Mean
37636|NCT01483352|Secondary|Self Monitored Blood Glucose Levels|Participants monitored glucose levels on a daily basis and recorded for evaluation. Glucose levels are measured as milligrams per deciliter (mg/dL)|Screening, Week 12 and Months 6, 9 and 12|All participants were included in analysis; n= number of participants analyzed for the given parameter at the specified time point||mg/dL||Standard Deviation|Mean
37637|NCT01483352|Secondary|Hemoglobin A1c Levels|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. HbA1c levels are a measure of glycemic control.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percent of glycated hemoglobin||Standard Deviation|Mean
37638|NCT01483352|Secondary|Insulin Doses Dispensed From Insulin Pump|Total insulin dose (in international units per milliliter [IU/mL]) from pump was measured per day as mean per day measured over 7 days.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||IU/mL||Standard Deviation|Mean
37639|NCT01483352|Primary|Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally|Problems in ability to deliver insulin intraperitoneally was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
37640|NCT01483352|Primary|Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant|Signs of infection/allergic reaction at the site of implant was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
37641|NCT01483352|Primary|Percentage of Participants With Persistent Dull Pain Due to Catheter|Pain due to catheter was determined by a participant questionnaire and categorized as follows: Category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5= Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
37642|NCT01483352|Primary|Percentage of Participants With Signs of Pain in the Tissue Around the Port|Signs of pain was determined from the participant questionnaire which was categorized as follows: category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5=Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
37706|NCT01481740|Secondary|Neonatal Acidosis||intraoperative|||pH value||Standard Deviation|Mean
37643|NCT01483352|Primary|Percentage of Participants With Signs of Infection in the Tissue Around the Port|Signs of infection were determined by the physician and categorized as follows : Category 1= None; 2= Minor, negligible; 3= Some, noticeable 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
37644|NCT01483352|Primary|Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port|Signs of Redness/Swelling was determined by the physician and was categorized as follows: Category 1= None; 2= Minor, negligible; 3= Some, noticeable; 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
37645|NCT01483352|Primary|Percentage of Participants With Dislocation of Port|Position of the port was determined by the physician and was categorized as follows: Category 1= No dislocation; 2= Minimal dislocation; 3= Clearly visible dislocation, with minimal impairment of function; 4= Dislocation impairs functions; 5= Dislocation results in disabling functions. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint||percentage of participants|||Number
37646|NCT01483352|Primary|Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin|Mechanical stability of the device was determined by the stability of the ingrowth surrounding the port as determined by the physician. The ingrowth problems are categorized as follows: Category 1= complete stable Ingrowth, 2= Ingrowth working with negligible problems, 3= Ingrowth working with some problems, 4= Ingrowth working with major problems and 5= Ingrowth resulting in almost non-functional port. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the study; number (n)= number of participants analyzed for the given parameter at the specified timepoint||percentage of partcipants|||Number
37647|NCT01483352|Primary|Suitability of the Device - Overall Suitability Score|Suitability of the device was assessed by the investigator using a questionnaire that determined the following: 1) condition of the tissue around the port: tight connection between port and skin (mechanical stability, dislocation of port, signs of redness/swelling, infection, or pain), 2) peritoneal reactions (persistent dull pain due to catheter, signs of infection/allergic reaction) and ability to deliver insulin intraperitonally at every visit after implantation. Suitability score was determined using participant's responses to a questionnaire where 1 equals (=) no problem, 2=minor/negligible problems, 3=some/noticeable problems, 4=major/cumbersome and 5=severe/almost unbearable problems. Each question was scored and an average across the questions was determined as an overall score. The scores ranged from 1 (not at all suitable) to 5 (completely suitable).|Week 12|All participants who received the implant were included in the analysis.||units on a scale||Standard Deviation|Mean
37648|NCT01483209|Secondary|Digital Amputations|The number of digits amputated in our patient cohort is a secondary endpoint of this study. We will use a paired t-test to compare the number of digital amputations in the control versus experimental group.|12 months|Due to insufficient accrual, data analysis was not performed.|||||
37649|NCT01483209|Primary|Perfusion (as Determined by Laser Doppler Measurements)|A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).|12 months|Due to insufficient accrual, data analysis was not performed.|||||
37650|NCT01482910|Secondary|Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 – LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|At week 28|Full analysis set||Percentage of participants|||Number
37651|NCT01482910|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 – Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline and at week 28|Full analysis set||Letters correctly read||Standard Deviation|Mean
37652|NCT01482884|Secondary|Immunogenicity|Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.|Pre-dose sampling at baseline, Week 8, 12, 16, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.||participants|||Number
37653|NCT01482884|Secondary|Serum Concentration of Tralokinumab||Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.||ug/ml||Full Range|Mean
37654|NCT01482884|Secondary|Change From Baseline in Calprotectin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||ug/g||Full Range|Mean
37655|NCT01482884|Secondary|Change From Baseline in Albumin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||g/L||Full Range|Mean
37656|NCT01482884|Secondary|Change From Baseline in C - Reactive Protein||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||mg/L||Full Range|Mean
37657|NCT01482884|Secondary|Change From Baseline in Modified Riley Score|Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.||Grade on scale||Standard Error|Least Squares Mean
37707|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - postdelivery|||participants|||Number
37708|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - predelivery|||participants|||Number
37658|NCT01482884|Secondary|Change From Baseline in Partial Mayo Score|The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician’s global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.|From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants||Score on scale||Full Range|Mean
37659|NCT01482884|Secondary|Clinical Remission at Week 8 Based on Mayo Score|Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants||Percentage of participants|||Number
37660|NCT01482884|Secondary|Mucosal Healing at Week 8 Based on Mayo Score|Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.|Eight week treatment period|The full analysis set consist of all randomised participants||Percentage of participants|||Number
37661|NCT01482884|Secondary|Change in Mayo Score From Baseline to Week 8|Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.||Score on scale||Standard Error|Least Squares Mean
37662|NCT01482884|Primary|Clinical Response at Week 8 Based on Mayo Score|Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants||Percentage of responders|||Number
37663|NCT01482819|Primary|Endothelia Blebs|0 to 100% of area; measured as a percentage of corneal area with blebs.|after 20 minutes of lens wear|Subjects who were enrolled, randomized and completed the study.||percentage of area|Participants|Standard Deviation|Mean
37664|NCT01482819|Primary|Limbal Redness|grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study.||units on a scale|Participants|Standard Deviation|Mean
37665|NCT01482819|Primary|Corneal Swelling|measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured.||microns|Participants|Standard Deviation|Mean
37666|NCT01482767|Secondary|Number of Participants With Grade 2 or Higher Signs and Symptoms and Laboratory Abnormalities and Other Serious AEs|This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted. Refer to Outcome Measure 2 above for the safety outcome that includes the whole study duration from entry to week 72.|From study treatment dispensation to Week 28|This outcome measure was intended for a potential interim analysis which was not conducted.|||||
37667|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 16, 20, 24 and 28 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted.|Weeks (W) 16, 20, 24, and 28|This outcome measure was intended for a potential interim analysis which was not conducted.|||||
37668|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0.|Weeks (W) 4, 8, 12|All eligible participants with HCV RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.||participants|||Number
37669|NCT01482767|Secondary|CD4+ T-Cell Count (CD4) Change From Baseline|Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry.|Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants enrolled with CD4 result available from entry and the respective post-entry visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.||cells/mm^3||Inter-Quartile Range|Median
37670|NCT01482767|Secondary|Percentage of Participants With HIV-1 Viral Load <50 Copies/mL|HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL).|Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants with HIV-1 RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.||percentage of participants|||Number
37671|NCT01482767|Secondary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)|SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12.|12 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).||percentage of participants||95% Confidence Interval|Number
37709|NCT01481740|Primary|Incidence of Nausea and Vomiting||24hrs postoperative|||participants|||Number
37710|NCT01481740|Primary|Incidence of Nausea and Vomiting||2 hrs postoperative|||participants|||Number
37672|NCT01482767|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)|Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|From study treatment dispensation to Week 72|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).||percentage of participants||95% Confidence Interval|Number
37673|NCT01482767|Primary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)|SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24.|24 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).||percentage of participants||95% Confidence Interval|Number
37674|NCT01482429|Primary|Length of Intensive Care Unit Stay||days||||||
37675|NCT01482429|Primary|Duration of Mechanical Ventilation||days||||||
37676|NCT01482429|Primary|Duration of Weaning From Mechanical Ventilation||days|overall||days||Standard Deviation|Mean
37677|NCT01482429|Primary|Mortality||length of ICU stay (days)|Overall||participants|||Number
37678|NCT01482325|Primary|Data Collection for Engineering Development|"This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely.~Software iterations are not pre-defined."|After each iteration of software development|Subject analysis was not performed because study was prematurely terminated. Work on the project ceased when it was terminated.The study was intended to have the engineers review data produced by each blood pressure determination to work on new software algorithm in development. This was not and will not be conducted.|||||
37679|NCT01482312|Primary|Ocular Comfort|Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.|90 minutes|As treated.||cm|Participants|Standard Deviation|Median
37680|NCT01482312|Primary|Tear Osmolarity|The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.|90 minutes|As treated.||mOsms/L|Participants|Standard Deviation|Mean
37681|NCT01482091|Secondary|Hypoxia|Number of participants who had hypoxia within 30 min of study drug adminsitration|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
37682|NCT01482091|Secondary|Hypotension|Participants who had hypotension within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
37683|NCT01482091|Secondary|Respiratory Distress|Participants who had respiratory distress within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration|||participants|||Number
37684|NCT01482091|Secondary|Change in Pain Score|Due to confounding factors we were unable to obtain reliable data for this outcome|Baseline and immediately prior to IV insertion||||||
37685|NCT01482091|Secondary|Change in Pain Score at 30 Minutes|"Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points."|Baseline and 30 minutes after administration of study drug|||units on a scale||Inter-Quartile Range|Median
37686|NCT01482091|Secondary|Change in Pain Score at 10 Minutes|"Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points."|Baseline and 10 minutes after administration of study drug|||units on a scale||Inter-Quartile Range|Median
37687|NCT01482091|Secondary|Time to Study Drug Administration||Time from triage to adminstration of study drug|||minutes||Standard Deviation|Mean
37688|NCT01482091|Secondary|Total Amount of Narcotics Administered|Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure|Participants will be followed for the duration of their ED visit, an expected average of 6 hours||||||
37689|NCT01482091|Secondary|Length of Stay in ED|Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure|Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours||||||
37690|NCT01482091|Secondary|Admission Rate||This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage|||participants|||Number
37693|NCT01482091|Primary|Change in Pain Score 20 Minutes After Administration of Study Drug|"Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points."|Baseline and 20 minutes after administration of study drug|||units on a scale||Inter-Quartile Range|Median
37694|NCT01482065|Secondary|MRI Indices||6 Months|We were not able to obtain MRI data from 2 people within the CPAP group at 6 months. One withdrew from study and the other a clear scan could not be obtained.||percentage of fat in liver||Standard Deviation|Mean
37695|NCT01482065|Secondary|Analysis of Variance (ANOVA) in CPAP Versus No-CPAP Therapy on NAFLD|we will test our hypothesis that CPAP therapy improves NAFLD. The main independent variables will be CPAP vs. deferred-CPAP therapy. In a subanalysis, responses in the CPAP treatment group will be compared based on compliance. Compliance with CPAP is defined as using it on > 70% of the days, at least 4 h per night. Our primary outcome will be serum activity of ALT and AST. We will use ANOVA to examine changes in ALT and AST depending on CPAP therapy group and compliance. Secondary outcomes will include the degree of hepatic steatosis and fibrosis, as assessed by MRI.|6 months|We were unable to achieve enrollment goals due to limited clinical indications. Thereby not obtaining enough participant data to do an Analysis of Variance (ANOVA).|||||
37696|NCT01482065|Secondary|Liver Values|Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) activity.|6 Months|Withdrawal by subject in CPAP group.||U/L||Standard Deviation|Mean
37697|NCT01482065|Primary|Cross Sectional Analysis of NAFLD Versus Sleep Apnea Severity Indices (AHI)|Cross-sectional analysis will be performed in NAFLD study participants from the Johns Hopkins (JH) Hepatology Clinic to examine the relationship between findings on liver biopsy and sleep apnea severity indices. The main predictor variable will be presence/severity of OSA and nocturnal oxyhemoglobin desaturation (assessed by T90%, time w/ oxyhemoglobin desaturation < 90%; Delta SaO2 between baseline and minimal oxyhemoglobin saturation, and standard deviation of nocturnal SaO2). Our primary outcome will be NAFLD activity score on biopsy.|6 months|We were unable to obtain liver biopsy on most of our participants due to limited clinical indications.|||||
37698|NCT01481935|Primary|Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii|Swabs will be collected from the disposable gown and gloves of healthcare workers exiting the enrolled room. A single swab will be used for both gloves and the gown. The swab will be assayed for methicillin-resistant Staphylococcus aureus, multi-drug-resistant Acinetobacter baumannii, or both, depending on which organism(s) the occupant of the enrolled room is colonized with. The swab will be considered positive if the relevant organism is isolated. We will sample the first 15 healthcare worker exits after the room has received the allocated intervention.|As a healthcare worker exits the enrolled room (1 day)|Unit of analysis was the ICU room. Results from multiple participants who occupied a single room over the course of the trial were summarized by room.||percentage of positive cultures|Participants|Standard Error|Mean
37699|NCT01481896|Secondary|Patient Satisfaction Per Hip|Whether or not an individual is satisfied with the outcome of their hip arthroplasty is evaluated using a questionnaire. Since a participant with both hips replaced could have a different level of satisfaction for each hip, patient satisfaction is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|||number of participants|Participants||Number
37700|NCT01481896|Secondary|Component Revision Per Hip|For implants that require a component revision, the reason for the revision is determined based on the pre-operative history and operative findings at the time of revision. Since a participant with both hips replaced could have a revision of each hip, component revision is reported per hip.|At a mean of 6.7 years after primary total hip arthroplasty|||number of hips|Participants||Number
37701|NCT01481896|Secondary|Implant Stability Per Hip|Implant stability is classified and stable/bone ingrown, fibrous fixed or loose and evaluated using conventional radiographs. Since a participant with both hips replaced could have a different type of stability for each hip, implant stability is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|All hips that had a follow-up x-ray taken at least 4.75 years after their joint replacement were included.||number of hips|Participants||Number
37702|NCT01481896|Secondary|Osteolysis Per Hip|Osteolysis is defined as localized areas of peri-prosthetic bone loss that did not exist prior to surgery and is evaluated using radiographs and CT scans. Since a participant with both hips replaced could have a osteolysis present or absent for each hip, osteolysis is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|Patients who had radiographs or computed tomography (CT) scans taken as part of routine care were included.||Number of hips with osteolysis|Participants||Number
37703|NCT01481896|Secondary|Harris Hip Score Per Hip|Harris Hip Scores are derived from a patient questionnaire and physical examination. Since a participant with both hips replaced could have different Harris Hip Scores for each hip, the Harris Hip Scores are reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|||units on a scale|Participants|Full Range|Median
37704|NCT01481896|Secondary|Cup Orientation Per Hip|Cup orientation including abduction and anteversion is determined using follow-up radiographs. Since a participant with both hips replaced could have different cup orientations for each hip, cup abduction and anteversion angles are reported per hip.|On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty|Cup orientation was measured for all 131 total hip replacements included in the study population.||degrees|Participants|Full Range|Median
37705|NCT01481896|Primary|Metal Ion Levels Per Participant|Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced.|At a mean of 4.2 years after primary total hip arthroplasty|Patients who had blood drawn and analyzed for serum cobalt levels as part of routine care are included.||micrograms per liter||Full Range|Median
37712|NCT01481558|Primary|Apathy Symptoms|Apathy evaluated by Apathy Scale by Starsktein et al, 1992, which consists of 14 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale. The total score range from 0 to 42, with higher scores indicating greater apathy severity. Apathy was assessed at baseline and at the end of the sixth session (second week).|Differences in outcome measure comparing second week to baseline|"alpha=5%, power=80%, SD estimated at 8 on Apathy scale scores, and correlation coefficient estimated at 0.7, a sample with 20 participants per arm is required to detect a between-group effect size of 0.5.~Intention to treat (ITT) analyses were conducted using the method of last observation carried forward (LOCF) for missing data."||units on a scale||95% Confidence Interval|Mean
37713|NCT01481376|Secondary|Hospital Length of Stay||Duration of the hospital stay (expected average of 1 day)|||Days||Standard Deviation|Mean
37714|NCT01481376|Secondary|Operative Time||From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)||||||
37715|NCT01481376|Secondary|Patient Satisfaction||at least 12 month post-operatively|||participants|||Number
37716|NCT01481376|Secondary|Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc||up to 12 months|||participants|||Number
37717|NCT01481376|Secondary|Analgesic Use||The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively||||||
37718|NCT01481376|Secondary|Incidence of Groin Pain (Pain Score 0-10)||12 month post-operatively|||participants|||Number
37719|NCT01481376|Primary|Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery.|Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin. The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the recurrence diagnosis is confirmed during a physical examination by a physician.|At least 12 months post-surgery|||participants|||Number
37720|NCT01481324|Primary|Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)|Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.|3 months|||percentage of time worn||Full Range|Mean
37721|NCT01481116|Secondary|Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104|The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline.|Baseline and Weeks 26, 52, 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
37722|NCT01481116|Secondary|Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia||Weeks 26, 52, 78 and 104|Data for this outcome measure was not analyzed as prespecified in the protocol.|||||
37723|NCT01481116|Secondary|Percentage of Participants With HbA1c <7%||Weeks 26, 52, 78 and 104|FAS included all randomized subjects who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.||percentage of participants|||Number
37724|NCT01481116|Secondary|Change From Baseline in HbA1c at Weeks 26 and 52|The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline.|Baseline and Weeks 26 and 52|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
37725|NCT01481116|Secondary|Change From Baseline in Body Weight at Weeks 78 and 104|The change between the body weight to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period. Data for body weight was not available at Week 104 due to early termination of the study.||kg||Standard Error|Least Squares Mean
37726|NCT01481116|Secondary|Percentage of Participants With Hypoglycemia|Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded.|Day 1 up to Weeks 78 and 104|Safety analysis set included all participants who received at least 1 dose of double-blind study medication. Participants were analyzed according to the study medication they received.||percentage of participants|||Number
37727|NCT01481116|Primary|Change From Baseline in HbA1c at Weeks 78 and 104|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline assessment.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
37728|NCT01480674|Secondary|The Duration of Treatment of Trastuzumab|Total treatment duration and duration of the first line of treatment is reported.|Up to 1 Year|Analyzed Set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.||Years||Standard Deviation|Mean
37729|NCT01480674|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.|Up to 1 year|The safety population set included of all participants who received at least one dose of study drug. Participants with available data in the prospective period were analysed.||Participants|||Number
37730|NCT01480674|Secondary|Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment|Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
37731|NCT01480674|Secondary|Dosage Schedule of Herceptin Treatment|Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.||Participants|||Number
37732|NCT01480674|Secondary|Overall Survival|The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.||Years||95% Confidence Interval|Median
37733|NCT01480674|Secondary|Time to Progression|The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.||Years||95% Confidence Interval|Median
37734|NCT01480674|Secondary|Progression-free Survival|The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.||Years||95% Confidence Interval|Median
37735|NCT01480674|Primary|Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment|Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.||Percentage of participants||95% Confidence Interval|Number
37736|NCT01480674|Primary|Tumor Hormone Receptor Status of Participants Without Progression|The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.||Percentage of participants||95% Confidence Interval|Number
37737|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores range from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
37738|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores ranges from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 12 and Week 24|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
37739|NCT01480596|Secondary|Number of Participants With MGFA-PIS (Unchanged, Improved, Worsened) at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being unchanged, improved or worsened.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
37808|NCT01479868|Secondary|Change From Baseline in CD4+ Cell Count in Percentage||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."||percentage of lymphocyte||Standard Deviation|Mean
37740|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Response Sustained Response (PR at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
37741|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Minimal Manifestation Sustained Response (MM at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
37742|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Remission or Better at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
37743|NCT01480596|Secondary|Number of Participants With a Myasthenia Foundation of America-post Intervention Status (MGFA-PIS) of Minimal Manifestation or Better at Week 24 and Week 36.|Myasthenia Foundation of America-post intervention status assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.|||||
37744|NCT01480596|Secondary|Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
37745|NCT01480596|Secondary|Median Time to MGC Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants' last available assessment prior to initiation of study intravenous (IV) infusion.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).|||||
37746|NCT01480596|Secondary|Number of Participants With a Sustained Response in the MGC Score|AA sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Odds ratios are calculated by Cochran-Mantel-Haenszel method without adjusting for any strata. Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
37747|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
37748|NCT01480596|Secondary|Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
37749|NCT01480596|Secondary|Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through to Week 24|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit.|Baseline and up to Week 24|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
37750|NCT01480596|Secondary|Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. Total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (mild) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at baseline (BL) is the average of the screening and Week 0 BL scores. Change from BL was calculated by subtracting the BL value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative trt difference indicates benefit relative to placebo. Analysis method was Mixed-Model Repeated Measures adjusted for Trt, Visit, BL QMG Score, Trt by Visit and BL QMG Score by Visit. Only follow-up visits are presented but the analysis also includes all trt phase visits. Only those par. available at indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.||Units on a scale||Standard Error|Least Squares Mean
37751|NCT01480596|Secondary|Median Time to QMG Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).|||||
37752|NCT01480596|Secondary|Number of Participants With a Sustained Response in the QMG Score|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Odds ratios are calculated by Cochran-Mantel-Haenszel method stratified by the observed median baseline score (<= median, > median). Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
37753|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through to Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (<=median, > median). Exact odds ratio, double the exact one-sided p-value and exact confidence interval were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
37754|NCT01480596|Secondary|Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (less than or equal to [<=] median, greater than [ >] median). Exact odds ratio, double the exact one-sided p-value and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.||Number of participants|||Number
37755|NCT01480596|Primary|Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means were presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline QMG Score, Treatment by Visit, and Baseline QMG Score by Visit.|Baseline and Week 24|Intent-to-Treat (ITT) Population includes participants in the Safety Population who has provided any post treatment efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
37756|NCT01480297|Primary|Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm|Intra-epidermal Nerve Fiber Density (IENFD) was measured at two anatomic locations (thigh and ankle) at baseline and after 12 weeks of treatment with Salsalate. IENFD is expressed as fibers per mm. Means and standard deviations are shown.|Baseline and 12 weeks|Type 1 diabetes with painful neuropathy||fibers per mm||Standard Deviation|Mean
37757|NCT01480284|Secondary|Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study)|"The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered Negative in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study)|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
37758|NCT01480284|Secondary|Number of Participants With Virological Breakthrough Through End of the Study|The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit.|From Baseline to throughout study|FAS Population||Participants|||Number
37759|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
37760|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
37761|NCT01480284|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBsAg and negative HBsAb at Baseline were analyzed.||Participants|||Number
37762|NCT01480284|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population.||Participants|||Number
37763|NCT01480284|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg and negative HBeAb at Baseline were analyzed.||Participants|||Number
37764|NCT01480284|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg at Baseline were analyzed.||Participants|||Number
37765|NCT01480284|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of IP and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.||Participants|||Number
37766|NCT01480284|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96|The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
37767|NCT01480284|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96|The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values.|Baseline, Week 48 and Week 96|Full Analysis Set (FAS) Population: all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation.||log10 copies/mL||Standard Deviation|Mean
37809|NCT01479868|Secondary|Mean Change From Baseline in CD4+ Cell Count||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."||cell counts per microliter||Standard Deviation|Mean
37768|NCT01480284|Primary|Mean Change From Baseline in Serum HBV DNA Level at Week 24|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 24|Per Protocol Set (PPS) Population: all participants who received at least 1 dose of investigational product (IP) and had at least one efficacy assessment after the treatment initiation, and with no major protocol violations. Missing values observed during the treatment period were imputed by the last observation carried forward (LOCF) method.||log10 copies/milliliter (copies/mL)||Standard Error|Least Squares Mean
37769|NCT01480219|Primary|Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)||Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8|Final analysis set included participants who met the eligibility criteria.||participants|||Number
37770|NCT01480089|Secondary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|12 hours after surgery|All individuals randomized are included in this analysis.||millimeters||Standard Deviation|Mean
37771|NCT01480089|Primary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|2 hours after surgery|All individuals randomized are included in this analysis.||millimeters||Standard Deviation|Mean
37772|NCT01480076|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|From signing of Informed Consent (SAEs) or from first dose of study treatment (AEs) through Week 50 or Early Termination (14 +/- 7 days after last dose)|Intent-to-treat population: all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit.||participants|||Number
37773|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of activity impairment||Standard Error|Least Squares Mean
37774|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of overall work impairment||Standard Error|Least Squares Mean
37810|NCT01479868|Secondary|Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here n signifies participants evaluable for this measure at specified time point."||copies per milliliter||Standard Deviation|Mean
38319|NCT01474200|Secondary|CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge|||Rehospitalizations|||Number
37775|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of impairment while working||Standard Error|Least Squares Mean
37776|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of work time missed||Standard Error|Least Squares Mean
37777|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37778|NCT01480076|Secondary|Change From Baseline in the Current Health State of EQ-5D VAS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37779|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the PRIMUS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37780|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37781|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37782|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37783|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37784|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of activity impairment||Standard Error|Least Squares Mean
37785|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of overall work impairment||Standard Error|Least Squares Mean
37811|NCT01479868|Secondary|Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure|Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.|Baseline to Week 72.|Participants who received potent anti-HIV treatment with a combination of more than 3 anti-antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed.||percentage of participants|||Number
38320|NCT01474200|Secondary|CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge|Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge|||Rehospitalizations|||Number
37786|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of impairment while working||Standard Error|Least Squares Mean
37787|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of work time missed||Standard Error|Least Squares Mean
37788|NCT01480076|Secondary|Change From Baseline in EQ-5D Index Scores at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37789|NCT01480076|Secondary|Change From Baseline in Current Health State of the EQ-5D VAS at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37790|NCT01480076|Secondary|Change From Baseline in the Activity Limitation Scale (ALS) of PRIMUS Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37791|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37792|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37793|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37794|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37795|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of activity impairment||Standard Error|Least Squares Mean
37796|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of overall work impairment||Standard Error|Least Squares Mean
37812|NCT01479868|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase Levels|Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.|Baseline up to Week 72|"The ITT population included all participants who received at least 1 dose of study drug. Here N signifies participants evaluable for this measure."||percentage of participants|||Number
37797|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of impairment while working||Standard Error|Least Squares Mean
37798|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS, by the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||percentage of work time missed||Standard Error|Least Squares Mean
37799|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying United Kingdom (UK) weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37800|NCT01480076|Secondary|Change From Baseline in the Current Health State of EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Months 3, 6, 9, And 12|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37801|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) at Months 3, 6, 9, and 12|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37813|NCT01479868|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.|Week 1 to 72|"The ITT population included all participants who received at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure."||percentage of participants|||Number
37814|NCT01479868|Secondary|Percentage of Participants With Viral Breakthrough|Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
37802|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37803|NCT01480076|Secondary|Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37804|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37805|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12). In contrast to the primary endpoint, this analysis was done using data from both responder and non-responder groups; therefore, 'responder group' and 'visit by responder group interaction' were included as fixed effects.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37806|NCT01480076|Primary|Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. Within-group least squares means are presented.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.||units on a scale||Standard Error|Least Squares Mean
37807|NCT01479868|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.|Week 1 to Week 72|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
37815|NCT01479868|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
37816|NCT01479868|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable|Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.|Week 4, 12, 24, 36, and 48|"ITT population included all participants who had at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure, n is the number of participants analyzed for this outcome measure at specific time points."||percentage of participants|||Number
37817|NCT01479868|Secondary|Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)|The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.|24 weeks after end of treatment (Week 24 or 48)|The ITT population included all perticipants who had at least 1 dose of study drug.||percentage of participants|||Number
37818|NCT01479868|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)|The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.|12 weeks after end of treatment (Week 24 or 48)|Intent to treat (ITT) population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
37819|NCT01479777|Secondary|Change in Peak Cough Flow|Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||liters/minute||Full Range|Mean
37820|NCT01479777|Secondary|Change in Vital Capacity|Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||litres||Full Range|Mean
37821|NCT01479777|Secondary|Change in Rate of Perceived Exertion|"Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters.~The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion."|Baseline, 8 weeks|||scores on RPE scale||Full Range|Mean
37822|NCT01479777|Secondary|Change in Diastolic Plood Pressure|Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||mmHg||Full Range|Mean
37823|NCT01479777|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||mmHg||Full Range|Mean
37824|NCT01479777|Secondary|Change in Heart Rate|Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.|Baseline, 8 weeks|||beats per minute||Full Range|Mean
37825|NCT01479777|Primary|Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)|"Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome.~AIS Classificatrion:~A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5.~B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.~C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.~D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.~E = Normal: motor and sensory function are normal."|Baseline, 8 weeks|||scores on AIS Scale||Full Range|Mean
37826|NCT01479764|Secondary|Time From Start of Study Drug Administration to Operating Room Discharge-ready|The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.|Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).||minutes||95% Confidence Interval|Least Squares Mean
37827|NCT01479764|Primary|Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry|Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|At PACU entry on Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate) and had a reliable TOF measurement at PACU entry.||participants|||Number
37828|NCT01479595|Secondary|Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.|baseline, 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||parts per billion (ppb)||Standard Error|Least Squares Mean
37829|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ug/mL||Standard Deviation|Mean
37830|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ng/mL||Standard Deviation|Mean
37831|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ug/mL||Standard Deviation|Mean
37832|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.||ng/mL||Standard Deviation|Mean
37833|NCT01479595|Secondary|Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies|Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.|12 weeks|All randomized participants||Participants|||Number
37834|NCT01479595|Secondary|Change From Baseline in Maximum Expiratory Flow|Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||L/sec||Standard Deviation|Mean
37835|NCT01479595|Secondary|Morning and Evening Peak Expiratory Flow (PEF) Rate|Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.|Baseline and 12 weeks|No analysis was performed on the collected data with the eDiary device due to overall poor data quality (values were obtained that were not physiologically possible) and high variability. Therefore, there is no data to present for this outcome measure.|||||
37836|NCT01479595|Secondary|Change in Asthma Quality of Life Questionnaire (AQLQ) Score|"The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.~Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes."|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
37837|NCT01479595|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||Liters||Standard Error|Least Squares Mean
37838|NCT01479595|Primary|Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
37839|NCT01479543|Secondary|Gastrointestinal and Immune Effects of Probiotics Consumption.|"Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks).~Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period)."|At Time zero, after 4 weeks, and 2 later.||||||
37840|NCT01479543|Primary|Gastrointestinal Tolerance After Probiotic Consumption.|"Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the number of participants was tolerant to the intervention."|4 weeks of the treatments. Daily recorded.|Calculation of simple size was based on the variance in the probiotic strain count (log strain CFU/g) in feces and a difference of 25% compared with the placebo. alfa: 0.05 power 90%||participants|||Number
37841|NCT01479530|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF||units on a scale||Standard Error|Mean
37857|NCT01479127|Secondary|Ratio of Metabolite 3-OMD to Levodopa (M/P [AUC0-12]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|M/P (AUC0-12) after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||ratio||Standard Deviation|Mean
37842|NCT01479530|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF||units on a scale||Standard Error|Mean
37843|NCT01479530|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 16|FAS; last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
37844|NCT01479530|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary|"Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.~The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time."|Baseline and Weeks 4, 8, 12, and 16|Full-analysis set (FAS); observed cases (OC)||hours||Standard Error|Mean
37845|NCT01479517|Secondary|Naris Examination|Number of patients with an abnormal naris examination finding.|60 minutes post drug administration|||Participants|||Count of Participants
37846|NCT01479517|Secondary|The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.||60 minutes|||participants|||Number
37847|NCT01479517|Secondary|The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.||60 minutes|||participants|||Number
37848|NCT01479517|Primary|The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure||at 15 minutes, with +10 minute window|||participants|||Number
37849|NCT01479374|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
37850|NCT01479374|Secondary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
37851|NCT01479374|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
37852|NCT01479374|Secondary|Mean Conjunctival Redness at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
37853|NCT01479374|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
37854|NCT01479374|Primary|Mean Ocular Itching at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
37855|NCT01479374|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.||Units on a scale||Standard Deviation|Mean
37856|NCT01479127|Secondary|Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
37898|NCT01478958|Primary|Percent Change in Flow Mediated Dilatation (FMD)||Baseline, 4 months|Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully.||post-occlusion diameter change as %||Standard Error|Mean
37858|NCT01479127|Secondary|Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Degree of Fluctuation (calculated as [Cmax – Cmin] / Cavg)) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||ratio||Standard Deviation|Mean
37859|NCT01479127|Secondary|AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12/Dose0-12 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). AUC0-16/Dose0-16 of levodopa, carbidopa, and 3-OMD after administration of intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||µg*h/mL/mg||Standard Deviation|Mean
37860|NCT01479127|Secondary|The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12 and AUC0-16 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||µg*h/mL||Standard Deviation|Mean
37861|NCT01479127|Secondary|Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Cmax, Cavg, Cmin, and Cmin (2-12 hours) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). Cmin values for levodopa and carbidopa during the 16 hours of infusion were observed either at time 0 or 15 min after start of the infusion and were a result of drug washout prior to establishment of infusion.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||µg/mL||Standard Deviation|Mean
37862|NCT01479127|Secondary|Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187|Tmax of levodopa, carbidopa, and its metabolite 3-O-methyldopa (3-OMD) after administration of oral L/C tablets and intra-jejunal administration of ABT-SLV187.|Baseline (Day -1): pre-dose; 15, 30, 45, 60 mins post-morning dose; every 30 mins thereafter for 12 hrs. Day 21: pre-dose; 15, 30, 45, 60 mins post-infusion; every 30 mins from hrs 1 to 12 post-infusion; every 2 hrs from 12 to 16 hrs post-infusion.|Pharmacokinetic (PK) sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.||hours||Standard Deviation|Mean
37863|NCT01479127|Primary|Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the “Normal” State on the Treatment Response Scale (TRS) I|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists’ evaluations was calculated as a percentage of ratings in the “Normal” state (ie, “mild OFF” to “ON with mild dyskinesia”) on the TRS I (total 10 assessments per day).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||percentage of ratings||Standard Deviation|Mean
37864|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period|High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
37865|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period|↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
37866|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
37867|NCT01479127|Secondary|Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||participants|||Number
37868|NCT01479127|Secondary|Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment|The Schwab and England scale was used to rate the subject’s activities of daily living by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Full Range|Median
37869|NCT01479127|Secondary|Modified Hoehn and Yahr Staging at Baseline and End of Treatment|Participant’s ON and OFF states staged according to the Modified Hoehn and Yahr criteria, an 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Full Range|Median
37870|NCT01479127|Secondary|Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients, including Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort, as well as a Summary Index Total Score. Scores for each are on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
37871|NCT01479127|Secondary|Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score ranges from 0-176, with 176 representing the worst (total) disability, and 0 no disability. The Part I Score is the sum of the answers to the 4 questions related to Mentation, Behavior and Mood, and ranges from 0-16. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. The Part IV Score is the sum of the answers to the 11 questions related to Complications of Therapy, and ranges from 0-23. The Part IV dyskinesia subscore ranges from 0-12. For each part of the UPDRS, higher scores are associated with more disability.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
37872|NCT01479127|Secondary|Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the video under blinded conditions using the following assessments: Tremor at Rest (UPDRS item #20), Finger Taps (UPDRS #23), Rapid Alternating Movement of Hands (UPDRS #25), Arising from Chair (UPDRS #27), Gait (UPDRS #29), Postural Stability (UPDRS #30), Body Bradykinesia and Hypokinesia (UPDRS #31), and Dyskinesia (evaluated with the Goetz Dyskinesia Rating Scale). The UPDRS score is the sum of the answers to individual questions, each of which are measured on a 5-point scale (0-4), with higher scores associated with more disability. The Goetz Dyskinesia Rating Scale is a 5-point scale of the severity of dyskinesias, from 0 (absent) to 4 (violent dyskinesias).|Baseline (Day -1), Endpoint (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
37873|NCT01479127|Secondary|Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment|For each half hour period during 3 consecutive days prior to each assessment of the diary, participants (and/or their caregivers) entered into a diary whether they were asleep, in the ON motor state or in the OFF motor state in the following 5 grades: asleep, OFF, ON (no dyskinesia [D]), ON with non-troublesome dyskinesia (NTD), ON with troublesome dyskinesia (TD). ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug. Dyskinetic time is time with involuntary muscle movement. The ON or OFF times were calculated as the average of 3 daily times from the diaries. w/o = without, w/ = with|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||hours||Standard Deviation|Mean
37874|NCT01479127|Secondary|Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the “OFF” and “Dyskinesia” States on the TRS I and the “Normal,” “OFF,” and “Dyskinesia” States on the TRS II|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and TRS under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia for TRS I, with the addition of Tremor at Rest and Postural Stability for TRS II. The average of the 3 neurologists’ evaluations was calculated as a percentage of ratings in the “Normal” state (ie, “mild OFF” to “ON with mild dyskinesia”), the “Off” state (“moderate OFF” to “severe OFF”), and the “Dyskinesia” state (“ON with moderate dyskinesia” to “ON with severe dyskinesia”) on the TRS I or II.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.||percentage of ratings||Standard Deviation|Mean
37875|NCT01479127|Primary|Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period|M=male, F=female|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
37876|NCT01479127|Primary|Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period|M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
39471|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 2 (week 1)||||||
37877|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period|M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
37878|NCT01479127|Primary|Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.||participants|||Number
37879|NCT01479127|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|During the Run-in period (up to approximately 28 days)|Full safety sample: participants who had at least one dose of oral levodopa-carbidopa study drug in the Run-in Period.||participants|||Number
37880|NCT01479010|Secondary|Oxygen Uptake Efficiency Slope||28 days||||||
37881|NCT01479010|Secondary|Total Exercise Time||28 days||||||
37882|NCT01479010|Secondary|Rate of Adverse Events and Hospitalizations||28 days||||||
37883|NCT01479010|Secondary|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||28 days||||||
37884|NCT01479010|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)||28 days||||||
37885|NCT01479010|Secondary|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||28 days||||||
37886|NCT01479010|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.|||||
37887|NCT01479010|Primary|Median Interval Change From Baseline in Peak VO2|Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.|||||
37888|NCT01478971|Secondary|Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion||12 months|Safety population||percentage of participants|||Number
37889|NCT01478971|Secondary|Percentage of Participants Who Received at Least One Intravenous Iron Dose|Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.|12 months|Safety population||percentage of participants|||Number
37890|NCT01478971|Secondary|Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL|Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.|Months 1, 2, 3, 4, 5 and 6 of each treatment period|Full Analysis Population included all enrolled participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period. n indicates the number of participants with available data at each time point.||percentage of participants|||Number
37891|NCT01478971|Secondary|Peginesatide Dose Deviations|Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.|Months 6 - 12||||||
37892|NCT01478971|Secondary|Peginesatide Dosing|The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.|Month 6 - 12|Participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period.||mg||Standard Deviation|Mean
37893|NCT01478971|Primary|Percentage of Participants Undergoing Conversion to Peginesatide Injection||6 months|All participants who received at least one dose of study treatment.||percentage of participants|||Number
37894|NCT01478958|Secondary|Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)|Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).|4 months||||||
37895|NCT01478958|Secondary|Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)|PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)|4 months||||||
37896|NCT01478958|Secondary|24-hour Ambulatory Blood Pressure|24-hour, daytime and night-time measures of systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP; SBP-DBP) and heart rate (HR)|4 months||||||
37897|NCT01478958|Secondary|Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)|Data for fasting serum lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC:HDL-C ratio, low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG)).|4 months||||||
37899|NCT01478828|Secondary|Capture Difference in MYC Downregulation Between Treated Participants and Non-treated Patients|7. To compare the MYC downregulation between our prostatectomy samples treated with high-dose lovastatin and up to 21 matched prostatectomy reference samples from untreated patients from a pre-existing reference dataset.|1 year||||||
37900|NCT01478828|Secondary|Number of Participants Who Follow All of the Study Rules.|6. To assess the study compliance.|1 year||||||
37901|NCT01478828|Secondary|Capture the Associated Changes in Participants With Regards to the Relationship Between MYC and Increased Apoptosis.|5. To assess an association of pharmacodynamic target inhibition of MYC with markers of increased apoptosis (cleaved caspase-3) and proliferation (Ki-67).|1 year||||||
37902|NCT01478828|Secondary|Capture the Pharmacodynamic Changes in Participants After the Pre-treatment Biopsy.|4. To assess the relationship of pharmacodynamic target inhibition of MYC with pretreatment prostate biopsy Gleason sum, Ki-67, and degree of MYC overexpression.|1 year||||||
37903|NCT01478828|Secondary|Number and Type of Cholesterol Changes After Lovastatin Treatments.|3. To characterize the effect of continuous daily oral lovastatin on cholesterol level in this patient population, at the doses tested in this trial.|1 year||||||
37904|NCT01478828|Secondary|To Estimate What the Doses Given to Men With MYC Target Inhibition When Factoring in Their Tumor Biopsies Before and After Lovastatin Treatment.|2. To estimate an overall and per dose proportion of men with MYC target inhibition in prostate tumor tissue using paired tumor biopsies before and after lovastatin administration.|1 year||||||
37905|NCT01478828|Secondary|Number of Participants Who Experience Specific Adverse Events at Different Dosing Points Prior to Surgery.|1. To assess the tolerability and toxicity of the different doses of continuous daily oral lovastatin in generally healthy men with prostate cancer prior to surgery.|1 year||||||
37906|NCT01478828|Primary|Number of Participants That Can Achieve 60% MYC Modulation Response|To determine the dose of continuous daily oral lovastatin needed to achieve MYC down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.|1 year|||participants|||Number
37907|NCT01478620|Secondary|Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)||||||
37908|NCT01478620|Secondary|Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)||||||
37909|NCT01478620|Secondary|Proportion of Patients Who Require Antibiotic Treatment Until Day 7||During active treatment period||||||
37910|NCT01478620|Secondary|Duration of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)||||||
37911|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 37||Day 37||||||
37912|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 7||Day 7||||||
37913|NCT01478620|Secondary|Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)||Day 7||||||
37914|NCT01478620|Secondary|Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days||During active treatment period||||||
37915|NCT01478620|Primary|Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N|No study drug related adverse drug reactions were registered.|During active treatment period (day 1 until day 7)|||Adverse Drug Reactions|||Number
37916|NCT01478594|Secondary|Progression-Free Survival Events by Tumor Placental Growth Factor (PIGF) RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor PIGF RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
37917|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-D RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-D RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
37918|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C / VEGF-A RNA Ratio|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C/VEGF-A RNA ratio.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
37919|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
39472|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|26 week follow up||||||
37920|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-A Ribonucleic Acid (RNA) Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-A RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples||participants|||Number
37921|NCT01478594|Secondary|Progression-Free Survival Events by Serum Neuropilin Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum neuropilin level. Neuropilin protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
37922|NCT01478594|Secondary|Progression-Free Survival Events by Serum Interleukin-8 (IL-8) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum interleukin-8 level. IL-8 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
37923|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-3 (sVEGFR-3) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-3 level. sVEGFR-3 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
37924|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-2 (sVEGFR-2) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-2 level. sVEGFR-2 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
37925|NCT01478594|Secondary|Progression-free Survival Events by Serum VEGF-C / VEGF-A Ratio|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C/VEGF-A ratio. VEGF-A and VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the ratio is expressed relative to the observed median.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
37926|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-C (VEGF-C) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C level. VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
37927|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-A (VEGF-A) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum vascular endothelial growth factor-A (VEGF-A) level. VEGF-A protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples||participants|||Number
37928|NCT01478594|Secondary|Progression-free Survival Events by Lactate Dehydrogenase (LDH) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum lactate dehydrogenase status.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||participants|||Number
37938|NCT01478373|Secondary|Overall Survival (OS) of Patients Treated With Dovitinib|Outcome Measure Description: OS: time from the date of entry into the study to the date of death due to any cause. A patient who has not died by the date of the analysis cut-off would have the OS censored at the time of the last contact before the cut-off date.|21 months (9 months of estimated treatment plus 12 months of survival follow up)|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Months||95% Confidence Interval|Median
37959|NCT01478009|Secondary|Symptom Severity of All Colds|"Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone.~Symptom severity of all colds (score 0–27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia).~Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst)."|12 weeks|per protocol analysis||Scores on a scale||Standard Deviation|Mean
37929|NCT01478594|Secondary|Safety as Assessed by Physical Examination, Vital Signs, Laboratory Assessments, 12-lead Electrocardiogram (ECGs), and Adverse Events (AEs)|"An abnormality identified during a medical test is defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion.~An AE was serious if it resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required or prolonged inpatient hospitalization or other medically important event.~AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute Common Terminology Criteria for Grading Adverse Events (NCI-CTCAE) Version 4.03 per the following: 1=mild; 2= moderate; 3= severe; 4= life threatening; 5=death.~Treatment-related AEs were defined as events where the relationship to study drug was marked as probably or possibly, or was missing."|From first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib (tiv) arm and 162.0 days in the bevacizumab (bev) arm.|The safety analysis set consisted of all randomized participants who received at least one dose of study drug (tivozanib or bevacizumab), analyzed according to the treatment actually received.||participants|||Number
37930|NCT01478594|Secondary|Health Related Quality of Life (HRQoL)|Time to deterioration in HRQoL measured by Colorectal cancer (CRC) subscale of the Functional Assessment of cancer Therapy Colorectal (FACT-C) scale, change in score from baseline using the European Quality of Life – 5 Dimensions (EQ-5D) and Fact Colorectal Symptom Index (FCSI) were not evaluated due to study closure.|3 years|Analysis was not performed due to study closure.|||||
37931|NCT01478594|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) is defined as the time from randomization to last dose date of tivozanib/bevacizumab. If a participant discontinued treatment for any reason, the participant was considered as an event. Participants remaining on treatment at the time of analysis were censored at date of last dose.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||months||95% Confidence Interval|Median
37932|NCT01478594|Secondary|Duration of Response (DoR)|Duration of response (DoR) is defined as the time from the date of the first documented response of CR or PR (whichever is first recorded) to documented progression or death. If a participant did not progress or had not died at the time of analysis, the duration of response was censored at the date of last tumor assessment. Duration of response is only defined for participants whose best overall response was CR or PR.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Participants with a best overall response of complete response (CR) or partial response (PR).||months||95% Confidence Interval|Median
37933|NCT01478594|Secondary|Objective Response Rate (ORR)|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) confirmed a minimum of four weeks apart based on RECIST 1.1 criteria.~CR: Disappearance of all target and non-target lesions and no new lesions.~PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and no progression of non-target lesions and no new lesions, or, disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||percentage of participants|||Number
37934|NCT01478594|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of randomization until the documented date of death. Participants still alive at the time of analysis were censored on the last day the participant was known to be alive.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set||months||95% Confidence Interval|Median
37935|NCT01478594|Secondary|Progression-Free Survival (PFS) Based on Independent Radiological Review (IRR)|The time from the date of randomization until the date of radiological disease progression assessed by the IRR or until death due to any cause, even in the absence of radiological progression.|3 years|Analysis was not performed due to study closure.|||||
37936|NCT01478594|Primary|Investigator-assessed Progression-Free Survival (PFS)|"The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1):~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.~Participants who did not progress or had not died at the time of the analysis were censored at the date of last tumor assessment where non-progression was documented."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|The full analysis set included all randomized participants.||months||95% Confidence Interval|Median
37937|NCT01478373|Secondary|DCR (CR+PR+SD) at the End of Treatment|DCR is defined as the proportion of patients with a best overall response of CR, PR and SD at the end of dovitinib treatment according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Up to 9 months of estimated treatment|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Percentage of Participants||90% Confidence Interval|Number
37939|NCT01478373|Secondary|Overall Response Rate (ORR) of Patients Treated With Dovitinib|Outcome Measure Description: ORR: proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Baseline, 12 weeks|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Percentage of Participants||90% Confidence Interval|Number
37940|NCT01478373|Secondary|Time to Tumor Progression (TTP)of Patients Treated With Dovitinib|TTP: time from the date of entry into the study to first documentation of tumor progression or death due to the underlying cancer. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||95% Confidence Interval|Median
37941|NCT01478373|Secondary|Duration of Response or Stable Disease (SD)|Duration of response or SD: time from date of entry into study to earliest date of first objective tumor progression or death. DCR is defined as proportion of patients with best overall response of CR, PR and SD at 12 weeks according to RECIST (version 1.1). CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1; PR: At least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||Standard Deviation|Mean
37942|NCT01478373|Secondary|Time to Treatment Failure (TTF)of Patients Treated With Dovitinib|TTF: the date of entry into the study to the earliest date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||95% Confidence Interval|Median
37943|NCT01478373|Secondary|Progression-free Survival (PFS) of Patients Treated With Dovitinib|The PFS duration: time from entry into the study to the date of the first documented progression (assessed using conventional RECIST (version 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Days||90% Confidence Interval|Median
37944|NCT01478373|Primary|Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease|DCR is defined as the proportion of patients with a best overall response of Complete Responses (CR), Partial Response (PR) and Stable Disease (SD) at 12 weeks according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|12 Weeks|Full Analysis Set: all subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.||Percentage of Participants||90% Confidence Interval|Number
37945|NCT01478360|Primary|Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score|The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.|Baseline and 85 Days|The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received.||Score||90% Confidence Interval|Least Squares Mean
37946|NCT01478347|Primary|Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).|The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include – AEs considered to be related to blood draw procedure and all SAEs.|Day 92 to day 331|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part two of the study.||subjects|||Number
37947|NCT01478347|Primary|Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.|The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.|Day 1 to day 91|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part one of the study.||subjects|||Number
37952|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele|ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele at randomization were analyzed.||percentage of participants||95% Confidence Interval|Number
37953|NCT01478048|Primary|1 Year Progression-Free Survival Rate - Randomized Participants|PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Year 1 after last participant was randomized|All randomized participants were analyzed.||percentage probability||95% Confidence Interval|Number
37954|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants|ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
37955|NCT01478048|Secondary|Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele were analyzed.||Months||95% Confidence Interval|Median
37956|NCT01478048|Primary|Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants|PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.|Randomization until 111 events, up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.||Events (progression or death)|||Number
37957|NCT01478048|Primary|Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.||Months||95% Confidence Interval|Median
37962|NCT01477892|Primary|Premature Infant Pain Profile|"P0-P2 units on a scale~; changes in PIPP from baseline (P0) to procedure (needle puncture, P2)~PIPP (preterm infant pain profile)~min 0 ~ max 21~higher pain scale on higher score"|first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop|||units on a scale||Standard Deviation|Mean
37963|NCT01477853|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 54 weeks|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.||Participants|||Number
37964|NCT01477853|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 56 weeks (including 2-week follow-up)|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.||Participants|||Number
37965|NCT01477853|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
37966|NCT01477853|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
37967|NCT01477853|Secondary|Percent Change From Baseline in Triglycerides at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
37968|NCT01477853|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
37969|NCT01477853|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
37970|NCT01477853|Secondary|Percent Change From Baseline in Total Cholesterol at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Error|Mean
37971|NCT01477853|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||mg/dL||Standard Error|Mean
37972|NCT01477853|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent change||Standard Deviation|Mean
37973|NCT01477853|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.|Baseline and Week 16|Full analysis set (FAS) population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.||Percent||Standard Error|Mean
37974|NCT01477749|Primary|Product Viability (Percentage)|Product viability was measured as the percentage of live PBMC in final product for infusion 1, 2, and 3 as measured by a trypan blue assay and are reported for each final product for infusion 1, 2, and 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||Percentage of PBMC that are live||Full Range|Mean
37975|NCT01477749|Primary|Cumulative Total Nucleated Cell (TNC) Count|Descriptive summarization of the cumulative sum of TNC counts across infusions|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||10^9 cells/mL||Standard Error|Mean
37976|NCT01477749|Primary|Cumulative CD54 Upregulation|The increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on post-culture versus pre-culture cells. Cumulative CD54 upregulation = CD54 upregulation ratio for infusion 1 + CD54 upregulation ratio for infusion 2 + CD54 upregulation ratio for infusion 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||Ratio||Standard Error|Mean
37977|NCT01477749|Primary|Cumulative CD54+ Cell Count|"Descriptive summarization of the cumulative sum of CD54+ counts across infusions.~Cumulative CD54 upregulation = CD54 upregulation for infusion 1 + CD54 upregulation for infusion 2 + CD54 upregulation for infusion 3"|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)|||10^9 cells/mL||Standard Error|Mean
37978|NCT01477710|Primary|Tidal Volume|Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded.|10 minutes per technique, for a total of 30 minutes per participant|||milliliters (mL)||Standard Error|Mean
37979|NCT01477567|Secondary|Number of Participants Forming Antibody to LY3009385|The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.|Baseline through Day 28|Participants who received a dose of LY3009385 or Placebo.||participants|||Number
37980|NCT01477567|Secondary|Change in Level of Glucagon Before and After a Standard Meal|The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.|Baseline, Day 14|Participants who received a dose of LY3009385 or Placebo and have evaluable glucagon concentration data. The effect of LY3009385 on postprandial glucagon concentrations was not evaluated on Day 14 for the 0.3 and 1 mg treatment arms.||picomoles per liter||Standard Deviation|Mean
37981|NCT01477567|Secondary|Change in Level of C-peptide Before and After a Standard Meal|The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable c-peptide concentration data.||picomoles times hours per liter||Standard Deviation|Mean
37982|NCT01477567|Secondary|Change in Level of Blood Glucose Before and After a Standard Meal|The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable blood glucose concentration data.||milligrams times hours per deciliter||Standard Deviation|Mean
37983|NCT01477567|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had evaluable LY3009385 concentration data.||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
37984|NCT01477567|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385|LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had sufficient quantifiable plasma LY3009385 concentrations in the terminal phase.||micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
37985|NCT01477567|Primary|Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs|The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 28|All enrolled participants.||participants|||Number
37986|NCT01477463|Secondary|Incidence of Hypercalcemia for Vitamin D Toxicity|Calcium levels|2 years|||participants|||Number
37987|NCT01477463|Secondary|Vitamin D Toxicity|serum 25(OH)D for|2 years|||ng/ml||Standard Deviation|Mean
37988|NCT01477463|Primary|Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment|We utilized a prior gene expression study that compared malignant melanoma cells to benign nevi (moles) and identified over 2300 genes that were differentially regulated in melanoma compared to benign nevi. There were approximately 270 genes in our data set that showed changes in expression after vitamin D treatment. We wish to identify overlap between these two groups.|2 years|||number of genes|||Number
37989|NCT01477463|Primary|Number of Genes That Showed Changes in Expression After Vitamin D Treatment|Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation.|2 years|All subjects treated with vitamin D3.||number of genes|||Number
37990|NCT01477450|Primary|Return of Oxygen Saturation to Baseline (Sea Level) Values|Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.|50 minutes|||participants|||Number
38009|NCT01476722|Primary|Corneal Fluorescein Staining Area at Day 30|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
37991|NCT01475734|Secondary|Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period|Treatment-emergent AEs are defined as those with an onset on or after study drug administration. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)|Safety Population: all participants who received one dose of albiglutide or placebo. The Safety Population was analyzed according to treatment received.||Participants|||Number
37992|NCT01475734|Secondary|Average Albiglutide Concentration on the Day of the Clamp Procedure|Plasma samples were taken from participants at two time points on Day 4 (at 0 hours and 4 hours and 45 minutes post-dose) of Week 1 of the study for albiglutide study drug level analyses. The average concentration for each participant was calculated as the mean of the concentrations at 0 hours and 4 hours 45 minutes. The clamp procedure is a glucose-controlled insulin infusion system. Variable infusions of glucose are administered to achieve various glucose target levels. It is a way of quantifying insulin secretion and resistance.|Day 4|Albiglutide Pharmacokinetic Population: all participants who had at least one sample to compute albiglutide exposure||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
37993|NCT01475734|Secondary|Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)|The effect of albiglutide and placebo on the recovery time of plasma glucose levels to >=3.9 mmol/L (7>=0 mg/dL) from the hypoglycemic clamp level of 2.8 nmol/L (50.4 mg/dL) was calculated as the time in minutes between switching off of the insulin infusion and reaching the level of >=3.9 mmol/L (>=70 mg/dL). Censored values were censored at 70 minutes. The median and 95% confidence interval data are obtained from Kaplan-Meier estimates.|Day 4|Pharmacodynamic Population||Minutes||95% Confidence Interval|Median
37994|NCT01475734|Secondary|C-peptide Values During the Glucose Clamp Period|C-peptide levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
37995|NCT01475734|Secondary|Cortisol Values During the Glucose Clamp Period|Cortisol levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
37996|NCT01475734|Secondary|Insulin Values During the Glucose Clamp Period|Insulin levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Picomoles per liter (pmol/L)||Standard Deviation|Geometric Mean
37997|NCT01475734|Secondary|Growth Hormone Values During the Glucose Clamp Period|Growth hormone levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Micrograms per liter (µg/L)||Standard Deviation|Geometric Mean
38124|NCT01475487|Secondary|Number of Attempts|Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.|not more than 300 seconds|||participants|||Number
37998|NCT01475734|Secondary|Norepinephrine Values During the Glucose Clamp Period|Norepinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
37999|NCT01475734|Secondary|Epinephrine Values During the Glucose Clamp Period|Epinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
38000|NCT01475734|Secondary|Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period|The insulin secretion rate (ISR) was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. ISR was measured at 1 hr, 1 hr 15 min, 1 hr 45 min, 2 hr, 2 hr 45 min, 3 hr, 3 hr 30 min, 3 hr 45 min, 4 hr 15 min, and 4 hr 30 min. Repeated-measures analysis of variance was performed on insulin secretion rate using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect.|Day 4|Pharmacodynamic Population||Milliunits per hour (mU/hr)||Standard Deviation|Mean
38001|NCT01475734|Primary|Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure|Plasma glucagon levels were measured for the estimation of glucagon secretion during the hypoglycemic periods. Glucagon response was measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on non-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification (0.03780 nmol/L) were set to the quantification limit for summary.|Day 4|Pharmacodynamic (PD) Population: all participants who received 1 dose of albiglutide or placebo, had a Baseline assessment, and had at least 1 post-Baseline assessment of the primary endpoint (glucagon) during the clamp procedure. PD Population participants were analyzed according to randomly assigned treatment.||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
38002|NCT01475721|Secondary|Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours|Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.|From Day 1 up to 26 weeks|mITT Population. Only those participants available at specified timepoint were analysed.||Number of Puffs||Standard Error|Mean
38003|NCT01475721|Secondary|Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|mITT Population||Participants|||Number
38004|NCT01475721|Secondary|Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death|Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility.|From Day 1 up to 26 weeks|ITT Population||Participants|||Number
38005|NCT01475721|Primary|Number of Participants Experiencing at Least One Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment.||Participants|||Number
38006|NCT01475721|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.|From Day 1 up to 26 weeks|Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug.||Participants|||Number
38007|NCT01476748|Primary|Trocar Slippages With LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes|Pilot study||Participants|||Number
38008|NCT01476748|Secondary|Trocar Slippages Without LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes|||Participants|||Number
38010|NCT01476722|Primary|Corneal Fluorescein Staining Area at Baseline|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
38011|NCT01476722|Primary|Corneal Fluorescein Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
38012|NCT01476722|Primary|Corneal Fluorescein Staining Type at Baseline|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.||Units on a scale||Standard Deviation|Mean
38013|NCT01476696|Secondary|Number of Participants With Hemorrhagic Events Requiring Medical Intervention|Hemorrhagic events were determined by the study investigator. Medical intervention was defined as any medical attention resulting in therapy or further investigation, as determined by a trained medical professional.|Part B: Baseline up to Day 36|Participants who received at least 1 dose of prasugrel.||participants|||Number
38014|NCT01476696|Secondary|Number of Participants With Pain|"The number of participants who answered yes to the first question in the Sickle Cell Disease Pain (SCD) Questionnaire is reported. Question 1: In the past 2 weeks, did you experience any sickle cell pain?"|Part B: Baseline and Day14 ± 4 days postdose in each dosing period|Participants who responded to Question 1 of the SCD Questionnaire. A participant could be counted more than once because there were 2 dosing periods during Part B of the study.||participants|||Number
38015|NCT01476696|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite|AUC of prasugrel inactive metabolite(s) from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)]. Improvements in bioanalytical methodology enabled direct measurement of Pras-AM from plasma, obviating the need to estimate its concentration from inactive downstream metabolite(s). Thus, the AUC of prasugrel inactive metabolite(s) was not analyzed.|Part A: 0.5, 1, 1.5, 2, 4 hours postdose|No participants were analyzed.|||||
38016|NCT01476696|Primary|Percentage of Platelet Inhibition as Measured by VerifyNow™P2Y12 (VN)|Accumetrics VN assay: A point-of-care device that measures platelet aggregation. Percentage of platelet inhibition is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and also during the once-daily repeated dosing phase in Part B, at steady state, 14 ± 4 days after each new dose (0.06, 0.08, and 0.12 mg/kg) is administered. One participant received the same dose at multiple visits (Part A) and one participant received the same daily dose during both dosing periods in Part B.|Part A: 4 hours postdose and Part B: at steady state (14 ± 4 days after the start of each new dosage)|Participants who received at least 1 dose of prasugrel.||percentage of platelet inhibition||Standard Deviation|Mean
38017|NCT01476696|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM)|AUC of Pras-AM from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)] is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and is reported for doses administered on site (0.06, 0.08, and 0.12 mg/kg) during Part B (once-daily repeated dosing phase) of the study. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected.|Parts A and B: 0.5, 1, 1.5, 2, 4 hours postdose|Participants who received at least 1 dose of prasugrel.||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
38018|NCT01476475|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)|Safety population that included all randomized participants who received at least 1 dose of study medication regardless of the amount of treatment administered.||percentage of participants|||Number
38019|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24|Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data.|Week 24|mITT population. Here, number of participants analyzed = participants with any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart or with one of the components (for HbA1c and body weight) showing non-response based on the last post-baseline on-treatment value.||percentage of participants|||Number
38321|NCT01474200|Secondary|CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge|Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs|Within 30 days and 90 days after hospital discharge|||Visits|||Number
38020|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Baseline up to Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
38021|NCT01476475|Secondary|Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24|30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
38022|NCT01476475|Secondary|Change in 30-minute and 1-hour PPG From Baseline to Week 24|The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline PPG assessment during on-treatment period. Here, 'n' signifies number of participants with available data for specified category.||mmol/L||Standard Error|Least Squares Mean
38023|NCT01476475|Secondary|Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24|On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
38024|NCT01476475|Secondary|Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
38025|NCT01476475|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
38026|NCT01476475|Secondary|Average Daily Insulin Glargine Dose at Week 24|Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with insulin glargine dose measured during on-treatment period||Units (U)||Standard Error|Least Squares Mean
38027|NCT01476475|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.||kg||Standard Error|Least Squares Mean
38028|NCT01476475|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
38029|NCT01476475|Secondary|Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24|2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with both baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
39473|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|12 week follow up||||||
38030|NCT01476475|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population.Here, number of participants analyzed = participants with both baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
38031|NCT01476475|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).|Baseline, Week 24|Modified intent-to-treat (mITT) population consisted of all randomized participants received at least 1 dose of IMP and had both baseline and at least 1 post-baseline efficacy assessment. Number of participants analyzed = participants with both baseline and at least one post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
38032|NCT01476345|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Gtot. Participants were analyzed based on the treatment they received.||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
38033|NCT01476345|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Rmax. Participants were analyzed based on the treatment they received.||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
38034|NCT01476345|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.||picomoles/Liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
38035|NCT01476345|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.||picomoles*hour/Liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
38036|NCT01476202|Secondary|Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)|AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique.||Score on a scale*minutes||95% Confidence Interval|Log Mean
38037|NCT01476202|Primary|Mean Change From Baseline in Nicotine Craving Score on a VAS|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.||Score on a scale||Standard Deviation|Mean
38038|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 7|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38039|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 6|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38322|NCT01474200|Secondary|CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge|Days rehospitalized for HF symptoms requiring hospital, emergency room or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs.|Within 30 days and 90 days after hospital discharge|||Days|||Number
38040|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38041|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38042|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38043|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 2|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|||participants|||Number
38044|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|||participants|||Number
38045|NCT01475955|Secondary|Scaling and Dryness at Visit 7|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38046|NCT01475955|Secondary|Scaling and Dryness at Visit 6|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38047|NCT01475955|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38048|NCT01475955|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38049|NCT01475955|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 2|||participants|||Number
38050|NCT01475955|Secondary|Scaling and Dryness at Visit 2|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|||participants|||Number
38051|NCT01475955|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|||participants|||Number
38052|NCT01475955|Secondary|Stinging/Burning at Visit 7|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38053|NCT01475955|Secondary|Stinging/Burning at Visit 6|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38054|NCT01475955|Secondary|Stinging/Burning at Visit 5 Post PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38055|NCT01475955|Secondary|Stinging/Burning at Visit 5 During PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|during PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38056|NCT01475955|Secondary|Stinging/Burning at Visit 5 (Pre-drug)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 8 prior to drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38057|NCT01475955|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38058|NCT01475955|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38059|NCT01475955|Secondary|Stinging/Burning at Visit 2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|24-48 hours post PDT #1|||participants|||Number
38060|NCT01475955|Secondary|Stinging/Burning Post Light-Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #1|||participants|||Number
38061|NCT01475955|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|During PDT #1 (most intense sensation)|||participants|||Number
38062|NCT01475955|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Baseline|||participants|||Number
38063|NCT01475955|Secondary|Edema at Week 24|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38064|NCT01475955|Secondary|Edema at Week 12|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38065|NCT01475955|Secondary|Edema Post PDT #2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38066|NCT01475955|Secondary|Edema at Visit 5 (Pre-drug)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38067|NCT01475955|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38068|NCT01475955|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38069|NCT01475955|Secondary|Edema at Visit 2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours post PDT#1|||participants|||Number
38070|NCT01475955|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1|||participants|||Number
38071|NCT01475955|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|||participants|||Number
38072|NCT01475955|Secondary|Erythema at Visit 7|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38073|NCT01475955|Secondary|Erythema at Visit 6|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38074|NCT01475955|Secondary|Erythema at Visit 5 (Post-light)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 5 minutes post light treatment|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38075|NCT01475955|Secondary|Erythema at Visit 5 (Pre-drug)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38076|NCT01475955|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38077|NCT01475955|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38078|NCT01475955|Secondary|Erythema at Visit 2|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|||participants|||Number
38079|NCT01475955|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1|||participants|||Number
38080|NCT01475955|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|||participants|||Number
38081|NCT01475955|Secondary|Hypopigmentation at Visit 7|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38082|NCT01475955|Secondary|Hypopigmentation at Visit 6|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38083|NCT01475955|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38084|NCT01475955|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38085|NCT01475955|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38086|NCT01475955|Secondary|Hypopigmentation at Visit 2|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 Hours after PDT #1|||participants|||Number
38087|NCT01475955|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|||participants|||Number
38088|NCT01475955|Secondary|Hyperpigmentation at Visit 7|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38089|NCT01475955|Secondary|Hyperpigmentation at Visit 6|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38090|NCT01475955|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38091|NCT01475955|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.||participants|||Number
38092|NCT01475955|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 2|||participants|||Number
38093|NCT01475955|Secondary|Hyperpigmentation at Visit 2|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 Hours after PDT #1|||participants|||Number
38094|NCT01475955|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|||participants|||Number
38095|NCT01475955|Secondary|Subject Satisfaction Score|"0 = no improvement or worsening (not satisfied at all)~= slight improvement (slightly satisfied)~= moderate improvement (moderately satisfied)~= excellent improvement (very satisfied)"|Week 24|||participants|||Number
38096|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 24|||percent clearance||Standard Deviation|Median
38097|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 12|||percent clearance||Standard Deviation|Median
38098|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 8|||percent clearance||Standard Deviation|Median
38099|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 4|||percent clearance||Standard Deviation|Median
38100|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline Week 24|||participants|||Number
38101|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 12|||participants|||Number
38102|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 8|||participants|||Number
38103|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 4|||participants|||Number
38104|NCT01475955|Secondary|Complete Clearance Rate|the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 24|||participants|||Number
38105|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8|||participants|||Number
38106|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 4|ITT LOCF||participants|||Number
38107|NCT01475955|Primary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data||participants|||Number
38108|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, >=6.0 log10) (kilo units per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population||Participants|||Number
38109|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized.|Baseline, Week 24, Week 48 and Week 96|FAS Population||participants|||Number
38158|NCT01475175|Primary|Stroke Volume During Sub-maximal Exercise.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.|Test day visit (within 14 days of enrollment)||||||
38110|NCT01475851|Secondary|Number of Participants With Virological Breakthrough and Resistance-related Mutations|"The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase >=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered negative in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||participants|||Number
38111|NCT01475851|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg)/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
38112|NCT01475851|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
38113|NCT01475851|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
38114|NCT01475851|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population||participants|||Number
38115|NCT01475851|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of investigational product and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.||participants|||Number
38116|NCT01475851|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96|The number of participants with serum HBV DNA level < the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 48 and Week 96|FAS Population.||participants|||Number
38117|NCT01475851|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation [i.e. 2.1 log10 copies/mL] for the assay were set to the lower limit minus 0.1 [i.e. 2.0 log10 copies/mL]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.|Baseline and Week 24, Week 48 and Week 96|FAS Population||log10 copies/mL||95% Confidence Interval|Mean
38118|NCT01475851|Primary|Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24|The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level < the lower limit of quantitation (2.1 log10 copies/millilitres[copies/mL]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA <2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.|Week 24|Full Analysis Set (FAS) Population: all participants who received at least one dose of investigational product (IP) and had at least one efficacy assessment after the start of study treatment.||participants|||Number
38119|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
38120|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
38121|NCT01475838|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set||percentage of participants|||Number
38122|NCT01475838|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: Participants who were randomized and treated, and had no major eligibility criteria violations||percentage of participants|||Number
38123|NCT01475487|Secondary|Correct Landmarking|Correct landmarking by all participants between the ultrasound and digital palpation group|less than 300 seconds|||participants|||Number
38125|NCT01475487|Primary|The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries|The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)).|On avergae less than 300 seconds|||Participants|||Number
38126|NCT01475487|Secondary|Insertion Time|Defined as palpation of the skin to completion of procedure- cannula in trachea.|less than 5 minutes from starting of procedure|||seconds||Standard Deviation|Mean
38127|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores.|"The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20.~This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner)."|Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.||Percentage change||Inter-Quartile Range|Median
38128|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings.|This co-primary effectiveness endpoint was calculated as a relative percentage of the baseline Accidental Bowel Leakage (ABL) using the following equation: % reduction in ABL = 100*(baseline period ABL - treatment period ABL) / (baseline period ABL)|Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.||percentage change||Inter-Quartile Range|Median
38129|NCT01475461|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||participants|||Number
38130|NCT01475461|Secondary|Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 8 , 12 , 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure and n=participants who were evaluable at given time points for each group.||kilogram (kg)||Standard Deviation|Mean
38131|NCT01475461|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||events per participant||Full Range|Median
38132|NCT01475461|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||percentage of participants|||Number
38133|NCT01475461|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
38159|NCT01475175|Primary|Stroke Volume During Atrial Pacing.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.|Test day visit (within 14 days of enrollment)||||||
38134|NCT01475461|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator’s discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||participants|||Number
38135|NCT01475461|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data|Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia’s correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.||participants|||Number
38136|NCT01475461|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.|Week 12|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure.||percentage of participants|||Number
38137|NCT01475461|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14||Baseline (Day 1), Week 1, 2, 4, 8, 12, 14|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 1 had not been reported because as per protocol it was not intended to be collected.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
38138|NCT01475461|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline(Day 1), Week 2, 4, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.||percentage of hemoglobin||Standard Deviation|Mean
38139|NCT01475461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.||percentage of hemoglobin||Standard Deviation|Mean
38140|NCT01475253|Secondary|Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings|Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner’s lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.|Baseline, Day 14|Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||percentage of participants|||Number
38141|NCT01475253|Secondary|Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score|Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||score on a scale||Standard Deviation|Mean
38142|NCT01475253|Secondary|Change Form Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||score on a scale||Standard Deviation|Mean
38143|NCT01475253|Secondary|Change From Baseline in Voiding Frequency|Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||Voids||Standard Deviation|Mean
38160|NCT01475175|Primary|Stroke Volume at Rest|Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.|Test day visit (within 14 days of enrollment)||||||
38144|NCT01475253|Secondary|Change From Baseline in Urinary Urgency as Assessed by VAS|Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words “No Urgency” (best) at the left end (0 cm) and the words “Urgency as bad as you can imagine” (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
38145|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 42|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
38146|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 28|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
38147|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 14|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
38148|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 7|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||centimeters||Standard Deviation|Mean
38149|NCT01475253|Secondary|Percentage of Responders Using the Global Response Assessment (GRA)|Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.||Percentage of Responders|||Number
38150|NCT01475214|Primary|Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen|Describe and compare changes in 24-hour urinary nitrogen in the low and high dose and KHCO3 group and in placebo.|84 days|healthy men and women age 60 years and older||mmol/day||Standard Error|Mean
38151|NCT01475214|Primary|The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide|Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses.|84 days|Healthy men and women age 60 years and older||nmol/day||Standard Error|Mean
38152|NCT01475175|Secondary|Electrical Conduction During Sub-maximal Exercise.|Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.|Time Frame: Test day visit (within 14 days of enrollment)||||||
38153|NCT01475175|Secondary|Cardiac Function With Nominal Settings During Sub-maximal Exercise.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.|Test day visit (within 14 days of enrollment)||||||
38154|NCT01475175|Secondary|Cardiac Function With aCRT Settings During Sub-maximal Exercise.|Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.|Test day visit (within 14 days of enrollment)||||||
38155|NCT01475175|Secondary|Electrical Conduction at Rest.|Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval. The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.|Test day visit (within 14 days of enrollment)||||||
38156|NCT01475175|Secondary|Cardiac Function With Nominal Settings at Rest.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.|Test day visit (within 14 days of enrollment)||||||
38157|NCT01475175|Secondary|Cardiac Function With aCRT Settings at Rest|Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.|Test day visit (within 14 days of enrollment)||||||
38161|NCT01475097|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.|Overall Image Quality rated as ‘Excellent, Adequate or Poor’ by radiologists blinded to the contrast administration.|Within 10 minutes post contrast administration.|"A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis.~This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis."||participants|||Number
38162|NCT01475097|Primary|Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography|The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.|Within 10 minutes post contrast administration.|249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol.||participants|||Number
38163|NCT01475071|Primary|Pain Score|Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)|Baseline (during procedure), assessed after procedure|ITT population||units on a scale||Standard Deviation|Mean
38164|NCT01475071|Primary|Lesion Response|Percent of lesions treated at Baseline, in complete response at Week 12|Week12|Only Per Protocol subjects are included in this analysis||percentage of lesions complete response||Standard Deviation|Mean
38165|NCT01474993|Secondary|Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene and Protein Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks||Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks||||||
38166|NCT01474993|Secondary|Change From Screening and Baseline in Urinary Isoprostane F2α-VI Levels at 24 Hours After First Dose, at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks||Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks||||||
38167|NCT01474993|Secondary|Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||*10^3 cells/µL||Standard Deviation|Mean
38168|NCT01474993|Secondary|White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||*10^3 cells/µL||Standard Deviation|Mean
38169|NCT01474993|Secondary|Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||*10^6 cells/µL||Standard Deviation|Mean
38170|NCT01474993|Secondary|Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||uIU/mL||Standard Deviation|Mean
38171|NCT01474993|Secondary|Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||mg/dL||Standard Deviation|Mean
38172|NCT01474993|Secondary|Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks|||U/L||Standard Deviation|Mean
38173|NCT01474993|Secondary|Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Ohio Autism Clinical Impressions Improvement Scale (OACIS-I) is a 10 domain scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.~Each domain is rated on a scale of 1 to 7, where “1” is very much improved; “2” is much improved; “3” is minimally improved; “4” is no change; “5” is minimally worse; “6” is much worse; or “7 is very much worse."|4 weeks, 10 weeks, 18 weeks, 22 weeks|||units on a scale||Standard Deviation|Mean
38174|NCT01474993|Secondary|Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"OACIS-S is a 10 domain scale that requires the clinician to rate the severity of the patient's autism symptoms at the time of assessment. The 10 domains cover different aspects of patients’ behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.~Each domain is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily."|4 weeks, 10 weeks, 18 weeks, 22 weeks|||units on a scale||Standard Deviation|Mean
38175|NCT01474993|Secondary|Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of 0 for particular behavior is not a problem at all, 1 indicates that the behavior is a problem but slight in degree, 2 indicates that the problem is moderately serious, and 3 indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome.~For the purposes of this study, ABC scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average ABC scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks, 22 weeks|||units on a scale||Standard Deviation|Mean
38176|NCT01474993|Primary|Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated on the scoring sheet on a scale from 0 to 3, where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome.~For the purposes of this study, SRS scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average SRS scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks and 22 weeks|||units on a scale||Standard Deviation|Mean
38177|NCT01474915|Secondary|Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during a delayed period after neurological surgery under general anesthesia.~- Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.~Nausea is evaluated by a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting is evaluated by the investigator or nursing staff numerically as either 0, no vomiting;, 1, mild vomiting;, 2, moderate vomiting;, or 3, severe vomiting."|24 hours post-operatively|Severity of nausea and vomiting||units on a scale||Full Range|Mean
38178|NCT01474915|Primary|Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during the first 24 hours after neurological surgery under general anesthesia.~- Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia.~Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia.~Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia."|24 hours post operatively|Number of patients with Complete Control||participants|||Number
38179|NCT01474876|Secondary|Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis who received adalimumab treatment||Percentage of participants|||Number
38180|NCT01474876|Primary|Percentage of Participants With Peripheral Symptoms in Remission|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)||Percentage of participants||95% Confidence Interval|Number
38181|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis|The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with psoriatic arthritis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with psoriatic arthritis who received adalimumab treatment.||Percentage change||Standard Deviation|Mean
38182|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
38183|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)||Odds Ratio||95% Confidence Interval|Number
38192|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)||Odds Ratio||95% Confidence Interval|Number
38323|NCT01474200|Secondary|CLINICAL: Length of Stay (LOS) During the Index Hospitalization|Number of days patient is in hospital for HF treatment.|Index hospitalization admission to index hospitalization discharge|||Days||Standard Deviation|Mean
38184|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)||Correlation coefficient|||Number
38185|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
38186|NCT01474876|Secondary|Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis who received adalimumab treatment||Percentage of participants|||Number
38187|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis|Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with ankylosing spondylitis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with ankylosing spondylitis who received adalimumab treatment.||Percentage change||Standard Deviation|Mean
38188|NCT01474876|Secondary|Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study|Participants were surveyed at each study visit for their use of NSAID medication.|Baseline (Visit 0) to 12 months|Participants who were receiving NSAID medication at baseline||Percentage of participants|||Number
38189|NCT01474876|Secondary|Duration of Treatment With Adalimumab|The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment||Months||Standard Deviation|Mean
38190|NCT01474876|Secondary|Mean Frequency of Extra-articular Manifestations (EAMs)|Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn’s disease or ulcerative colitis).|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment||Mean EAMs per participant||Standard Deviation|Mean
38191|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
38529|NCT01472432|Primary|Capillary Density|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.~Capillary density is measured using immunohistochemistry"|3 months of treatment with vildagliptin|||capillaries/mm2||Inter-Quartile Range|Median
38193|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)||Correlation coefficient|||Number
38194|NCT01474876|Secondary|Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
38195|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)||Units on a scale||Standard Deviation|Mean
38196|NCT01474876|Primary|Percentage of Participants With Active Axial Symptoms in Remission|The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)||Percentage of participants||95% Confidence Interval|Number
38197|NCT01474876|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)||Percentage of participants||95% Confidence Interval|Number
38198|NCT01474876|Primary|Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline|The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of the BASDAI > 4).||Percentage of participants||95% Confidence Interval|Number
38199|NCT01474772|Secondary|Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The EQ-5D describes participant`s health status based on 5 attributes producing an 5 digit index score. The 5 dimensions are: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Dolan 1997 advised how to transfer this index score to a single score for clinical trials, a revised single index was published in 2001. The index uses general population weighted estimates for various health states. In general, the range of the single index tends to vary between 0 = death and 1 = perfect health and there are some states that have been rated by the general population to be worse than death which may result in numbers below 0.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38228|NCT01474512|Secondary|Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)||Weeks 12 and 24|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had Ctrough ss results at specified time points where the concentration met the definition of being a trough concentration.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
38200|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38201|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38202|NCT01474772|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates “does not interfere with sleep” and 10 indicates “completely interferes (unable to sleep due to pain)”. Self-assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38203|NCT01474772|Secondary|Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (OS; 7 different scores) and categorized scores (CS; 4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V6).|End of Period 1 (V6)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||percentage of participants|||Number
38204|NCT01474772|Secondary|Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The autonomic domain score should be summed as follow: Σ(19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38205|NCT01474772|Secondary|Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38227|NCT01474512|Secondary|Percentage of Participants With Anti-ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline through Week 12|All randomized participants who received at least 1 dose of study drug and had evaluable data.||percentage of participants|||Number
38206|NCT01474772|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38207|NCT01474772|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38208|NCT01474772|Secondary|Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The symptoms domain score should be summed as follow: Σ(1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38209|NCT01474772|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38210|NCT01474772|Secondary|Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|The Walk-12 is a self-administered questionnaire that assesses the impact of the participant’s diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38211|NCT01474772|Secondary|Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||steps||Standard Error|Least Squares Mean
38246|NCT01474434|Secondary|Interleukin-6 (IL-6) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
38212|NCT01474772|Secondary|Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|"Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||counts||Standard Error|Least Squares Mean
38213|NCT01474772|Secondary|BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38214|NCT01474772|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38215|NCT01474772|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38216|NCT01474772|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||percentage of participants|||Number
38217|NCT01474772|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||percentage of participants|||Number
38247|NCT01474434|Secondary|Other Related Lipid Parameters (Part A)||Baseline, day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
38218|NCT01474772|Primary|DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)|The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38219|NCT01474772|Post-Hoc|Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The longitudinal mean weekly DPN pain scores were defined as the mean of 7 daily diary pain ratings. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).||units on a scale||Standard Deviation|Mean
38220|NCT01474772|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the Intent-to-Treat (ITT) analysis (N: 203). This was the primary analysis set.||units on a scale||Standard Error|Least Squares Mean
38221|NCT01474551|Primary|Overall Objective Response|The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.|2 years|||participants|||Number
38222|NCT01474538|Secondary|Percentage of Participants With Hypoglycemic Events|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.||percentage of participants|||Number
38223|NCT01474538|Secondary|Change From Baseline in Weight|Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%), baseline weight and participants.|Baseline, Week 16 of treatment Periods 1 and 2|All randomized participants who received at least 1 dose of study drug and had weight measured at baseline and Week 16 of Treatment Period 1 or 2. Participants were analyzed based on the treatment they received.||kilograms (kg)||Standard Error|Least Squares Mean
38224|NCT01474538|Secondary|Rate of Hypoglycemic Events Per 30 Days|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%).|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.||hypoglycemic events per 30 days||Standard Error|Least Squares Mean
38225|NCT01474538|Secondary|Total Daily Insulin Dose|Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%) and participants.|Week 16 of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug and had total daily insulin dose recorded during Treatment Period (TP) 1 or 2. If endpoint data was missing for a specific TP, last observation carried forward (LOCF) method was implemented for that respective TP. Participants were analyzed based on the treatment they received.||units of insulin||Standard Error|Least Squares Mean
38226|NCT01474538|Primary|Glycosylated Hemoglobin A1C (HbA1c) at Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (>8% or ≤8%) and participants.|After 16 weeks of each treatment (Periods1 and 2)|All randomized participants who received at least 1 dose of study drug and had HbA1c measured at Week 16 of treatment Period 1 or 2. Participants were analyzed based on the treatment they received.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
38248|NCT01474434|Secondary|Pharmacokinetics of Pradigastat (LCQ908): Plasma Concentration (Part A)||Part A: Day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
38229|NCT01474512|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps at baseline.||percentage of participants|||Number
38230|NCT01474512|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.||units on a scale||Standard Error|Least Squares Mean
38231|NCT01474512|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. It comprises 36-items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.||units on a scale||Standard Error|Least Squares Mean
38232|NCT01474512|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.||units on a scale||Standard Error|Least Squares Mean
38233|NCT01474512|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])|WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
38234|NCT01474512|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.||units on a scale||Standard Error|Least Squares Mean
38235|NCT01474512|Secondary|Percent of Body Surface Area (BSA) Involvement of Ps|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.||percentage of body surface||Standard Error|Least Squares Mean
38236|NCT01474512|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.||units on a scale||Standard Error|Least Squares Mean
38237|NCT01474512|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM)."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had at least 1 post-baseline DLQI measurement.||units on a scale||Standard Error|Least Squares Mean
38238|NCT01474512|Secondary|Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had an Itch NRS score ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
38239|NCT01474512|Secondary|Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|Maintenance Period Primary Population (MPPP): all randomized participants from Period 2 who achieved sPGA (0, 1), were re-randomized at Week 12 and who received at least 1 dose of study treatment Period 3 period. Participants did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
38240|NCT01474512|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
38241|NCT01474512|Secondary|Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
38242|NCT01474512|Primary|Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.||percentage of participants|||Number
38243|NCT01474512|Primary|Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|"The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.||percentage of participants|||Number
38244|NCT01474434|Secondary|Adiponectin Level ( Part B)||Part B; Baseline, day 15, day 43 and day 85|The study was terminated based on the interim analysis on Part A, cohort 1 after patients completed Part A. Part B of the study was not commenced.|||||
38245|NCT01474434|Secondary|C-reactive Protein (CRP) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.|||||
39474|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)||||||
38249|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 2)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour (before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.||ratio||Standard Error|Geometric Mean
38250|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 1)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour(before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.||ratio||Standard Error|Geometric Mean
38251|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 2)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.||Participants|||Number
38252|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 1)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.||Participants|||Number
38253|NCT01474434|Primary|Aortic Plaque Inflammation (Part B)|This endpoint was palnned for analysis on Part B patients which was never started becasue study got terminated on Part A interim analysis.|Baseline and on treatment day 85 +/- 3 days|The study was terminated based on the interim analysis after patients completed Part A. Part B of the study was never started.|||||
38254|NCT01474434|Primary|Time to Onset of Exercise-induced Ischemia(Part A, Cohort 1)|Exercise-induced ischemia was defined as the new development of horizontal or down-sloping ST-segment depression (≥ 1mm at 60 milliseconds after the J point) versus baseline tracings.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .|||||
38255|NCT01474434|Primary|Time to Onset of Angina (Part A, Cohort 1)|Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the patient and recorded by the performing investigator.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .|||||
38256|NCT01474434|Primary|Change From Baseline in Total Exercise Duration (Part A, Cohort 1)|Total exercise duration was the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline and on day 5 of each of the two treatment periods|Efficacy analysis set- Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of total exercise duration at both baseline and post-treatment visits. Patients who had no baseline or post-treatment exercise duration data in 1 of 2 periods were excluded from the analysis.||minute||Standard Error|Least Squares Mean
38257|NCT01474434|Primary|Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)|MPRi (myocardial perfusion reserve index) is a measure of coronary microvascular function. Myocardial perfusion scans using 0.05 mmol/kg of gadolinium contrast were acquired at rest and under stress (pharmacological stress induced with adenosine 140 μg/kg/min for three minutes). An independent central reader performed the cardiac image analysis of all time points including the calculation of the myocardial perfusion reserve index from the ratio of the global stress myocardial blood flow divided by the resting blood flow values. Higher/increased index indicates improved flow/better outcome. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline, and on day 5 of each of the two treatment periods|Efficacy analysis set - Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of MPRi at both baseline and post-treatment visits. Patients who had no baseline or post-treatment MPRi data in 1 of 2 periods were excluded from the analysis.||myocardial perfusion reserve index||Standard Error|Least Squares Mean
38258|NCT01474317|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?'|1 hour|||participants|||Number
38259|NCT01474317|Secondary|Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<75mg/dL YSI venous plasma) or +/- 5to20% (>=75mg/dL YSI venous plasma).|1 hour|Venipuncture was unsuccessful for one subject. 223 (224-1) venous blood test results were analyzed.||percentage of meter test results|||Number
38260|NCT01474317|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for 3 subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.||percentage of meter test results|||Number
38261|NCT01474317|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.||percentage of meter test results|||Number
38262|NCT01474291|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding if accompanied by clinical symptoms, results in a change in study treatment, results in a medical intervention or a change in concomitant therapy or clinically significant in the investigator’s judgment), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 30 months|Safety population, defined as participants who received at least one infusion of tocilizumab.||percentage of participants|||Number
38263|NCT01474291|Secondary|Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire.|"Participants were asked: If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) unacceptable? The percentage of participants who responded acceptable at each time point is presented."|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.||percentage of participants|||Number
38264|NCT01474291|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score|The RAID questionnaire is a participant-reported outcome measure evaluating the impact of rheumatoid arthritis on participant quality of life. This composite index score ranges from 0 (best) to 10 (worst) and includes questions regarding 7 domains (pain, functional disability assessment, fatigue, sleep, physical well-being, emotional well-being, coping). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6, Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.||units on a scale||Standard Deviation|Mean
38265|NCT01474291|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI is a participant-reported assessment of ability to perform daily living activities. This composite index score ranges from 0 (normal) to 3 (total functional disability) and includes questions regarding 8 domains (dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.||units on a scale||Standard Deviation|Mean
38266|NCT01474291|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12|"EULAR response was categorized as good or moderate response and was calculated as the difference between DAS28-ESR scores at baseline and Month 12. DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity.~If diminution from baseline >1.2 and score ≤3.2 at Month 12 = good response~If diminution from baseline >1.2 and score >3.2 at Month 12 = moderate response~If diminution from baseline >0.6 and ≤1.2, and score ≤5.1 at Month 12 = moderate response~If diminution from baseline >0.6 and ≤1.2, and score >5.1 at Month 12 = non-response~If diminution from baseline ≤1.2 at Month 12 = non-response~Participants with missing data were considered as non-response"|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38267|NCT01474291|Secondary|Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12|ACR20/50/70 response was calculated as improvement (from baseline) of at least 20/50/70% (respectively) of tender and of swollen joints, and improvement from baseline of least 20/50/70% (respectively) in at least 3 of the 5 following parameters: participant's pain assessment, patient's global assessment of disease activity, physician’s global assessment of disease activity, health assessment questionnaire disability index (HAQ-DI) score, and ESR (mm/hour) or CRP (mg/L). Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38268|NCT01474291|Secondary|Percentage of Participants With SDAI Remission at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, CRP (mg/L), and the patient’s global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤3.3 was considered to be SDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38269|NCT01474291|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, C-reactive protein (CRP) (milligrams per liter (mg/L)) per , and the patient’s global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤11 was considered to be SDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
39475|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)||||||
38270|NCT01474291|Secondary|Percentage of Participants With CDAI Remission at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient’s global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤2.8 was considered to be CDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38271|NCT01474291|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient’s global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤10 was considered to be CDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38272|NCT01474291|Secondary|Percentage of Participants With DAS28-ESR Remission at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of <2.6 was considered to be DAS28-ESR remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38273|NCT01474291|Secondary|Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of ≤3.2 was considered to be DAS28-ESR LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38274|NCT01474291|Secondary|Percentage of Participants With at Least One csDMARD Intensification During the Study|csDMARD intensification was defined as an addition of a csDMARD without suppression of other csDMARD, dose increase of a csDMARD, switch (addition and suppression) of a csDMARD without intolerance, biological abnormality or symptom improvement to the suppressed csDMARD, or modification of the MTX administration route (from oral route to intramuscular/subcutaneous) with dose increase or maintenance.|Up to 30 months|Participants in Efficacy population who received at least 1 infusion of tocilizumab, who met all inclusion/exclusion criteria, and with no permanent discontinuation of tocilizumab treatment over the study period. For efficacy criteria with response/non response values, participants with non-evaluable response were considered as non-responders.||percentage of participants|||Number
38275|NCT01474291|Secondary|Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period|The percentage of participants with no modifications (dose modification or discontinuation) is presented.|Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38276|NCT01474291|Secondary|Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period|The percentage of participants who received infusions is presented by category of total infusions received over the study period.|Up to 13.4 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||percentage of participants|||Number
38277|NCT01474291|Secondary|Mean Number of Tocilizumab Infusions Over the Study Period||Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||infusions||Standard Deviation|Mean
38278|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs)|The percentage of participants who discontinued treatment with unspecified csDMARDs prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued treatment with unspecified csDMARDs and with available data.||percentage of participants|||Number
38279|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine|The percentage of participants who discontinued hydroxychloroquine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued hydroxychloroquine and with available data.||percentage of participants|||Number
38280|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine|The percentage of participants who discontinued sulfasalazine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued sulfasalazine and with available data.||percentage of participants|||Number
38281|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide|The percentage of participants who discontinued leflunomide treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued leflunomide and with available data.||percentage of participants|||Number
38530|NCT01472432|Primary|Full Epithelialization of the Wound|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.~Optic microscopy is used to evaluate the epithelialization of the wound."|3 months of treatment with vildagliptin|||participants|||Number
38282|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)|"The percentage of participants who discontinued MTX treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.~Reason for discontinuation Other Intolerance = intolerance other than cytopenia or hepatic cytolysis."|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued MTX and with available data.||percentage of participants|||Number
38283|NCT01474291|Primary|Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion|The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.|Day 1|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.||participants|||Number
38284|NCT01474239|Secondary|Time to WHO PS Deterioration|Time to WHO PS deterioration was defined as the time from randomization to the first date of deterioration of the WHO performance status score. WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.||months||95% Confidence Interval|Median
38285|NCT01474239|Secondary|Percentage of Participants With World Health Organization (WHO) Performance Status (PS) Deterioration|WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.||percentage of participants|||Number
38286|NCT01474239|Secondary|Time to Karnofsky Performance Status (KPS) Deterioration|Time to KPS deterioration was defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Time to KPS deterioration was estimated using Kaplan Meier method. If the participant was not known to have the event, time was censored at the last available visit date.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.||months||95% Confidence Interval|Median
38287|NCT01474239|Secondary|Percentage of Participants With Karnofsky Performance Status (KPS) Deterioration|Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.||percentage of participants|||Number
38288|NCT01474239|Secondary|Percentage of Participants in Each Class of Corticosteroid Use|Corticosteroid use was classified as: 1. No Change (if corticosteroid dose at each assessment was equal to baseline); 2. Decreased (if corticosteroid dose at each assessment was lower than baseline); 3. Increased (corticosteroid dose at each assessment was greater than baseline).|Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, post-treatment follow-up (up to Day 691)|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."||percentage of participants|||Number
38289|NCT01474239|Secondary|Time to Corticosteroid Initiation|Time to corticosteroid initiation was defined as the time from screening to the start date of the first corticosteroid administration in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage ≥2 mg dexamethasone equivalent. Instead, if the participant was not known to have the event, time was censored at the last available visit date. Time to corticosteroid initiation was estimated using Kaplan Meier method.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.||months||95% Confidence Interval|Median
38290|NCT01474239|Secondary|Percentage of Participants With Corticosteroid Initiation During the Study Period|Corticosteroid initiation was assessed in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage greater than equal to (>/=) 2 mg dexamethasone equivalent.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.||percentage of participants|||Number
38291|NCT01474239|Secondary|Change From Screening in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores at Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|EORTC QLQ-C30: included global health status/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global QOL/functional scales indicates better level of QOL/functioning, or a higher score for symptom scale indicates greater degree of symptoms.|Screening, Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."||units on a scale||Standard Deviation|Mean
38301|NCT01474213|Primary|Intubation Score|graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing|during the inserting of the tracheal tube|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.||units on a scale||Inter-Quartile Range|Median
39476|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 10 (week 5)||||||
38292|NCT01474239|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Percentage of participants achieving CR or PR as overall response between first drug administration and documented disease progression were calculated. Tumor response was evaluated according to both the RANO and the Macdonald response criteria. As per Macdonald criteria, CR was defined as the disappearance of all enhancing disease, sustained for at least 4 weeks, and no new lesions along with clinical features of clinically stable or improved, with no corticosteroid; PR was defined as a 50% or more decrease of all measurable enhancing lesions, sustained for at least 4 weeks, and no new lesion along with clinical features of clinically stable or improved, with stable or reduced corticosteroids. RANO criteria defined CR and PR the same as Macdonald criteria with the following additions: CR - improved non enhancing T2/FLAIR lesions; PR - no progression of non-measurable disease, stable or improved non enhancing FLAIR/T2 lesions.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.||percentage of participants|||Number
38293|NCT01474239|Secondary|Percentage of Participants Alive 30 Days After Last Dose of Study Drug|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|30 days after last dose of study drug (up to Day 600)|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.||percentage of participants||95% Confidence Interval|Number
38294|NCT01474239|Secondary|Percentage of Participants Alive 12 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|12 months|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.||percentage of participants||95% Confidence Interval|Number
38295|NCT01474239|Secondary|Percentage of Participants Alive 9 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|9 months|ITT population.||percentage of participants||95% Confidence Interval|Number
38296|NCT01474239|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using the RANO or the Macdonald Response Criteria, whichever occurred first. As per RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.||months||95% Confidence Interval|Median
38297|NCT01474239|Secondary|Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment|Progression-free survival (PFS) was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using Response Assessment in Neuro-Oncology (RANO) or Macdonald Response Criteria, whichever occurred first. As per the RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per the Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|6 months|ITT population.||percentage of participants||95% Confidence Interval|Number
38298|NCT01474239|Primary|Overall Survival (OS)|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|Baseline until death (up to 691 days)|ITT population.||months||95% Confidence Interval|Median
38299|NCT01474239|Primary|Percentage of Participants Alive 6 Months After Start of Treatment|Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|6 months|Intent-to-Treat (ITT) population included all randomized participants with at least one administration of the study drug.||percentage of participants||95% Confidence Interval|Number
38300|NCT01474213|Secondary|Post Intubation Score|"Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome.~Post-intubation score 1 2 3~Cooperative, obeying commands~Uncomfortable, GA imminent~Other（specify）"|immediately after the intubation|||units on a scale||Inter-Quartile Range|Median
38302|NCT01474213|Primary|Endoscopy Scores|"Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition.~Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing"|during the procedure of fibreoptic and tracheal intubation|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.||units on a scale||Inter-Quartile Range|Median
38303|NCT01474213|Secondary|Cardiac Rhythm|Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.|15 minutes before intubation and duration of intubation|||participants|||Number
38304|NCT01474213|Secondary|Peripheral Oxygen Saturation(SPO2)|Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point|||percentage oxygen saturation||Standard Deviation|Mean
38305|NCT01474213|Secondary|Heart Rate|Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point|||beats per minute||Standard Deviation|Mean
38306|NCT01474213|Secondary|Mean Arterial Blood Pressure|MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point|||mmHg||Standard Deviation|Mean
38307|NCT01474213|Secondary|Post Operative Visit|visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.|24 hours|||participants|||Number
38308|NCT01474213|Secondary|Patient's Reaction to Procedure|"Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level.~Clinical score Level of sedation~Patient is anxious and agitated or restless, or both~Patient is cooperative, oriented and tranquil~Patient responds to commands only~Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus~Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus~Patient exhibits no response to stimuli"|the duration of intubation, an expected average of 10 minutes|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.||units on a scale||Inter-Quartile Range|Median
38309|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mL/min/1.73m2||Standard Deviation|Mean
38310|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mg/dL||Standard Deviation|Mean
38311|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Baseline: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mg/dL||Standard Deviation|Mean
38312|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.||mg/dL||Standard Deviation|Mean
38313|NCT01474200|Secondary|CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge|KCCQ Questionnaire analysis based on patient's self-assessment of how they feel at various intervals compared to how they felt prior to index treatment. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=92 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.||Scores on a Scale||Standard Deviation|Mean
38314|NCT01474200|Secondary|CLINICAL: Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge|Questionnaire assessed patients quality of life prior to index treatment versus timeframes following hospital discharge. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=91 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.||Scores on a Scale||Standard Deviation|Mean
38324|NCT01474200|Secondary|EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time|Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.|Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=108 for AQ arm, n=109 for LD arm. 72 hours from baseline: n=81 for AQ arm, n=77 for LD arm. Discharge: n=83 for AQ arm, n=89 for LD arm. 90 days follow up: n=65 for AQ arm, n=76 for LD arm.||pg/mL||Standard Deviation|Mean
38325|NCT01474200|Secondary|EFFICACY: Freedom From Congestion|Defined as jugular venous distention of < or equal to 8 cm, with no orthopnea, and with trace peripheral edema or no edema at hospital discharge|Index Hospitalization, an average of 8 days|||Participants|||Number
38326|NCT01474200|Secondary|EFFICACY: Time to Freedom From Congestion|Time from hospital admission to time patient is free of congestion in the hospital. Freedom from congestion is defined as jugular venous distention of < or equal to 8 cm, with no orthopnea and with trace peripheral edema or no edema. Measurement taken every 24 hours after treatment initiation.|Index Hospitalization, an average of 8 days|||Days||Standard Deviation|Mean
38327|NCT01474200|Secondary|EFFICACY: Total Weight Loss During the Index Hospitalization|Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.|Index Hospitalization, an average of 8 days|||lbs||Standard Deviation|Mean
38328|NCT01474200|Secondary|EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment|Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.|72 hours after treatment initiation|||lbs||Standard Deviation|Mean
38329|NCT01474200|Secondary|EFFICACY: Net Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.|Index Hospitalization, an average of 8 days|||mL||Standard Deviation|Mean
38330|NCT01474200|Secondary|EFFICACY: Total Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics|Index Hospitalization, an average of 8 days|||mL||Standard Deviation|Mean
38331|NCT01474200|Primary|Time to First Heart Failure (HF) Event|"Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as~HF rehospitalization or~unscheduled outpatient or emergency room treatment with IV loop diuretics or~unscheduled outpatient Aquapheresis treatment"|90 days after discharge from index HF hospitalization.|Results reported are for the 25th percentile.||Days||95% Confidence Interval|Median
38332|NCT01474122|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis – Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Units on a scale||Standard Deviation|Mean
38333|NCT01474122|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Units on a scale||Standard Deviation|Mean
38334|NCT01474122|Secondary|Change in Hand Functionality Health Assessment Questionnaire – Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Units on a scale||Standard Deviation|Mean
38335|NCT01474122|Secondary|Percentage of Participants With at Least One DU Complication|"DU complications were defined as any one of the following:~resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs."|Up to 95 weeks|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Percentage of participants|||Number
38336|NCT01474122|Secondary|Percentage of Participants Without a New DU up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.||Percentage of participants|||Number
38337|NCT01474122|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to Week 16|Full analysis set||new DUs/16 weeks|||Number
38338|NCT01474109|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis – Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||units on a scale||Standard Deviation|Mean
38339|NCT01474109|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||units on a scale||Standard Deviation|Mean
38340|NCT01474109|Secondary|Change in Hand Functionality Health Assessment Questionnaire – Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||units on a scale||Standard Deviation|Mean
38341|NCT01474109|Secondary|Percentage of Participants With at Least One DU Complication|DU complications were defined as any one of the following, resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.|Up to approximately 90 weeks|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||percentage of participants|||Number
38342|NCT01474109|Secondary|Percentage of Participants Without a New DU Up To Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to week 16|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.||Percentage of participants|||Number
38343|NCT01474109|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to week 16|Full analysis set||number of new DUs/observation days|||Number
38344|NCT01473992|Primary|Physical Functional Performance (Continuous Scale; 10-items)|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.|||scores on a scale||Standard Deviation|Mean
39477|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 9 (week 5)||||||
38345|NCT01473992|Secondary|Prosthesis Evaluation Questionnaire: Utility Score.|The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||score on a scale||Full Range|Median
38346|NCT01473992|Secondary|Balance and Stability|Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||scores on a scale||Standard Deviation|Mean
38347|NCT01473992|Primary|75 Meter Self Selected Walking Test|Time to Complete a 75 meter walking distance.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||seconds||Standard Deviation|Mean
38348|NCT01473953|Secondary|Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up||Day 0 and Day 21|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.||participants|||Number
38349|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment||0 to 168 hours after dosing|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.|||||
38350|NCT01473953|Secondary|Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment||1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
38351|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. This evaluation was not done on placebo cohort.||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
38352|NCT01473953|Secondary|Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.||hours||Geometric Coefficient of Variation|Geometric Mean
38353|NCT01473953|Secondary|Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.||pmol/L||Geometric Coefficient of Variation|Geometric Mean
38354|NCT01473953|Primary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.|Day 0 and up to 21 days after treatment|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.||events|||Number
38355|NCT01473836|Secondary|Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole|Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.|Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.|No population pharmacokinetic analysis results are available just for the current study.|||||
38356|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Investigator Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
38382|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Initial Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percent||Standard Error|Least Squares Mean
38357|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Data Review Committee Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
38358|NCT01473836|Secondary|Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)|"The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; number of participants assessed as continuation over total number of participants that excluding ones assessed as indeterminate multiplied by 100."|Baseline to Day 4|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants|||Number
38359|NCT01473836|Secondary|Clinical Response: Response Rate (Investigator Assessment)|"Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting effective” criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
38360|NCT01473836|Primary|Clinical Response: Response Rate (Data Review Committee Assessment)|"Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting effective” criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."||percentage of participants||95% Confidence Interval|Number
38361|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Extended Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||meters/second||Standard Error|Least Squares Mean
38362|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Initial Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||meters/second||Standard Error|Least Squares Mean
38363|NCT01473758|Secondary|Exacerbation Length (Extended Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||days||95% Confidence Interval|Median
38364|NCT01473758|Secondary|Exacerbation Length (Initial Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||days||95% Confidence Interval|Median
39386|NCT01460732|Primary|Awake Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks|||mmHg||Standard Deviation|Mean
38365|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Extended Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||hours||Standard Error|Least Squares Mean
38366|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Initial Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||hours||Standard Error|Least Squares Mean
38367|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Extended Approach)|Any changes in the participant’s usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Error|Least Squares Mean
38368|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Initial Approach)|Any changes in the participant’s usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
38369|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Extended Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Error|Least Squares Mean
38370|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Initial Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
38371|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Extended Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||liters/minute||Standard Error|Least Squares Mean
38372|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Initial Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||liters/minute||Standard Error|Least Squares Mean
38381|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Extended Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percent||Standard Error|Least Squares Mean
38373|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||scores on a scale||Standard Error|Least Squares Mean
38374|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
38375|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Deviation|Mean
38376|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Deviation|Mean
38377|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||scores on a scale||Standard Error|Least Squares Mean
38378|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Error|Least Squares Mean
38379|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||score on a scale||Standard Deviation|Mean
38380|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||score on a scale||Standard Deviation|Mean
38448|NCT01473589|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.~Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.||percentage of participants|||Number
38383|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Extended Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||liters||Standard Error|Least Squares Mean
38384|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Initial Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||liters||Standard Error|Least Squares Mean
38385|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Extended Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||liters||Standard Error|Least Squares Mean
38386|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Initial Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||liters||Standard Error|Least Squares Mean
38387|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Extended Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||mmol/L||Standard Error|Least Squares Mean
38388|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Initial Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||mmol/L||Standard Error|Least Squares Mean
38389|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Extended Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||umol/L||Standard Error|Least Squares Mean
38390|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Initial Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||umol/L||Standard Error|Least Squares Mean
38391|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Extended Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||mg/L||Standard Error|Least Squares Mean
38392|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Initial Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||mg/liter(L)||Standard Error|Least Squares Mean
38393|NCT01473758|Secondary|Change From Baseline in Blood Biomarker IL-1β (Extended Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
38394|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin-1 Beta (IL-1β) (Initial Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
38395|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Extended Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
38396|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Initial Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
38397|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||µg/mL||Standard Error|Least Squares Mean
38398|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||µg/mL||Standard Error|Least Squares Mean
38399|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||ng/mL||Standard Error|Least Squares Mean
38400|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||ng/mL||Standard Error|Least Squares Mean
38401|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
38784|NCT01467882|Secondary|Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12|This is a lab test to see what percentage of children were returned to lower than normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 6, 9 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
38402|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
38403|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||pg/mL||Standard Error|Least Squares Mean
38404|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||pg/mL||Standard Error|Least Squares Mean
38405|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocytes (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of lymphocytes||Standard Error|Least Squares Mean
38406|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocyte (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of lymphocytes||Standard Error|Least Squares Mean
38407|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of macrophages||Standard Error|Least Squares Mean
38408|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of eosinophils||Standard Error|Least Squares Mean
38409|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of macrophages||Standard Error|Least Squares Mean
38410|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of macrophages||Standard Error|Least Squares Mean
38411|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction. A negative change from Baseline indicates improvement.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of neutrophils||Standard Error|Least Squares Mean
38412|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of neutrophils||Standard Error|Least Squares Mean
38413|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
38414|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
38415|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||percentage of participants||95% Confidence Interval|Number
38416|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.||percentage of participants||95% Confidence Interval|Number
38417|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
38449|NCT01473589|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized and received at least 1 dose of study drug.||percentage of participants||90% Confidence Interval|Number
38418|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Analysis included all participants who received treatment in Cycle 1.||10^6 cells/gram sputum||Standard Error|Least Squares Mean
38419|NCT01473745|Secondary|1 Nasolabial Angular Parameters|2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®)|up to post-operation 6 months|||degree||Standard Deviation|Mean
38420|NCT01473745|Secondary|14 Nasolabial Linear Parameters|"baseline characteristics: intercanthulus distance~nasal linear parameters~nasolabial linear parameters"|up to post-operation 6 months|||mm||Standard Deviation|Mean
38421|NCT01473745|Primary|Soft and Hard Tissue Landmarks Movement|"The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy.~The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery."|The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.|similar sex distribution in both groups (7 male and 17 female patients in Group C, and 8 male and 16 female patients in Group M)||mm||Standard Deviation|Mean
38422|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.||Units on a scale||Standard Error|Least Squares Mean
38423|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..||Units on a scale||Standard Error|Least Squares Mean
38424|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..||Units on a scale||Standard Error|Least Squares Mean
38425|NCT01473602|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to Revision Surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 14; placebo = 19.||Days||Full Range|Median
38426|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement.||m/s||Standard Error|Least Squares Mean
38427|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement..||Units on a scale||Standard Error|Least Squares Mean
38494|NCT01473160|Primary|Average Tear Meniscus Height|The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.|Up to 16 hours after lens insertion|All enrolled participants||pixels||Standard Deviation|Mean
38428|NCT01473602|Secondary|Percentage of Participants Who Regained Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.||Percentage of participants|||Number
38429|NCT01473602|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received treatment and had at least 1 nonmissing post-baseline measurement. LOCF values used||Percentage of participants|||Number
38430|NCT01473602|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s.~Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|Up to 12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.||Percentage of participants|||Number
38431|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.||Percentage of participants|||Number
38432|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours.. LOCF values used.||Percentage of participants|||Number
38433|NCT01473602|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.||Percentage of participants|||Number
38434|NCT01473602|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.~Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.||Percentage of participants|||Number
38435|NCT01473602|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized, received at least 1 dose of study drug.||Percentage of participants||90% Confidence Interval|Number
38436|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.|Baseline, up to 6 Months|All randomized participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur, and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
38437|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
38438|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
38439|NCT01473589|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to revision surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 51; placebo = 51.||days||Full Range|Median
38440|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement.||m/s||Standard Error|Least Squares Mean
38441|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized and received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
38442|NCT01473589|Secondary|Percentage of Participants Who Regain Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.||percentage of participants|||Number
38443|NCT01473589|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.|Up to 12 months|Participants who were randomized and received at least 1 dose of study drug and had at least 1 nonmissing post-baseline measurement. LOCF values used.||percentage of participants|||Number
38444|NCT01473589|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.~Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.||percentage of participants|||Number
38445|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement. LOCF values used.||percentage of participants|||Number
38446|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours. LOCF values used.||percentage of participants|||Number
38447|NCT01473589|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received treatment, and had baseline and at least one nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.||percentage of participants|||Number
39387|NCT01460732|Primary|Asleep Diastolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
38450|NCT01473563|Secondary|Time to Treatment Failure (TTF)|The time from the date of the first dose of study treatment (Cycle 1, Day 1) to the date of death from any cause, PD (clinical and objective), or discontinuation of pemetrexed due to toxicity. Response was defined using RECIST, v1.1 criteria. PD was defined as having at least a 20% increase in the sum of the longest diameter of target lesions and at a minimum 5 mm increase above nadir. TTF was censored at the date of the last visit for participants who did not discontinue pemetrexed, who were still alive, and who had not progressed.|Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug. Two (2) participants were censored.||months||95% Confidence Interval|Median
38451|NCT01473563|Secondary|Overall Survival (OS) at 6 Months|The percentage of participants who were alive at Month 6 was calculated as a cumulative percentage by Kaplan-Meier survival analyses approach. For participants not known to have died as of the cut-off date, OS was censored as the last contact date (known alive).|Cycle 1, Day 1 to the date of death from any cause (up to Month 6)|ITT population: Participants who received at least 1 dose of study drug. Twenty-four (24) participants were censored (alive) at the end of the study.||percentage of participants||95% Confidence Interval|Number
38452|NCT01473563|Secondary|Resource Utilization: Distances Traveled|The distance traveled is reported by region (Great Britain and Sweden) and includes the distance traveled by the participant from his/her home to the hospital (Cycle 1) and other cycles where the homecare nurse traveled from the hospital to the participant's home. Due to the limited number of participants with evaluable data, results are reported for Cycles 1 through 4.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had data for distance traveled for at least 1 cycle from Cycle 1 through Cycle 4.||kilometers (km)||Standard Deviation|Mean
38453|NCT01473563|Secondary|Resource Utilization: Duration of Health Care Visits|The duration of the health care visit in the home setting is reported. The visit started when the nurse arrived and included the entire treatment process. The visit ended when the nurse left the home setting. Due to the limited number of participants with evaluable data, results are reported for Cycles 2 through 4.|Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 health care visit in the home setting from Cycle 2 through Cycle 4.||hours||Standard Deviation|Mean
38454|NCT01473563|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died|The number of participants who had at least 1 TEAE or serious TEAE (regardless of causality) is reported along with the number of participants who died (due to any cause) while on therapy or during treatment discontinuation follow-up (up to 6 months). TEAEs started on or after the date and time of first dose of study drug, or started prior to study drug but worsened after study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.|First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]|Safety Population: Participants who received at least 1 dose of study drug.||participants|||Number
38455|NCT01473563|Secondary|Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services|The unplanned use of any 1 of the following 4 resources is reported, as well as the unplanned use of each resource: accident and emergency dept., specialists (oncologist, pulmonologist etc.), GP or family doctor, and diagnostic procedures. Results are reported as the number of participants with an unplanned resource use (visit) for a specified number of times.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 unplanned use of health care resources.||participants|||Number
38456|NCT01473563|Secondary|Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources|The number of participants who had at least 1 unplanned use of health care resources [accident and emergency department (dept.), specialists [oncologist, pulmonologist, etcetera (etc.)], general practitioner (GP) or family doctor, or diagnostic procedures] during the study is reported.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug.||participants|||Number
38457|NCT01473563|Secondary|Physician Satisfaction: Distant Management of Participant|"The physician was asked, How would you rate your overall satisfaction with the distant management of the participant during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and for whom the investigator answered the specified question at 30 days post treatment discontinuation.||investigators|||Number
38458|NCT01473563|Secondary|Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment|"Participants were asked to evaluate their preferences regarding home and/or hospital treatment delivery in this study by answering 2 questions (Q). Q15: Do you prefer having your chemotherapy at home or at the hospital, or are you indifferent? Choices included: Home, Hospital, or Indifferent. Q16: Would you recommend having chemotherapy at home to someone else in your same situation? Choices included: Yes, No, or Not sure."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
38495|NCT01473160|Primary|Pre-Lens Noninvasive Tear Break-Up Time|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.|Up to 16 hours after lens insertion|All enrolled participants||seconds||Standard Deviation|Mean
39388|NCT01460732|Primary|Asleep Systolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
38459|NCT01473563|Secondary|Participant Satisfaction: Regarding the Study Nurse|"Participants were asked 7 questions (Q) about their study nurse for home treatment. Q8: Was the nurse an easy person to talk to?, Q9: When the nurse came, did you feel he/she had enough time to do the required things?, Q10: Do you think the nurse had time to discuss things with you?, Q11: Did you feel that the nurse knew enough about you and your illness? Choices for Q8 through Q11 included: Yes or No. Q12: Were you able to get all the information you wanted about your illness or treatment? Choices included: Yes, No, or Uncertain. Q13: Would you say that the nurse gave… Choices included: a lot of reassurance and support, some reassurance and support, or hardly any reassurance and support. Q14: How would you rate your overall satisfaction with the nursing staff during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
38460|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Home|"Participants were asked to evaluate their home treatment experiences in this study by answering 4 questions (Q). Q5: What do you do consider advantages of having chemotherapy at home? Choose all that apply. Choices included: No need to travel, Not having to wait for treatment, Personalized service, More privacy, and Other. Q6:What do you consider disadvantages of having chemotherapy at home? Choose all that apply. Choices included: Lack of other patients’ support, Extra burden for family/friends, Safety concerns, Need to rely on 1 medical specialist, and Other. Q7: How would you rate your overall satisfaction with chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
38461|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Hospital|"Participants were asked to evaluate their hospital experiences in this study by answering 4 questions (Q). Q1: What do you consider advantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Support from other patients, Access to other medical specialists, Access to more technical services, Safer in case something goes wrong, and Other. Q2: What do you consider disadvantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Need to travel, Having to wait for treatment, Not having a personalized treatment, Lack of privacy on the ward, and Other. Q3: How would you rate your overall satisfaction with chemotherapy at the hospital? and Q4: How would you rate your overall satisfaction with the nursing staff during chemotherapy at the hospital? Choices for Q3 and Q4 included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.||participants|||Number
38462|NCT01473563|Secondary|Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores|LCSS is a 9-item questionnaire; 6 items are symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe overall symptomatic distress, interference with activity level, and overall quality of life during the past 24 hours. Participant responses were measured using a VAS with 100-millimeter (mm) lines. Scores ranged from 0 mm (no symptoms and no impact on activities, quality of life) to 100 mm (symptoms as bad as they could be, impacting activities and quality of life).|Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline LCSS assessment.||mm||Standard Deviation|Mean
38463|NCT01473563|Secondary|Change From Baseline in the EQ-5D Index Score|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline EQ-5D Index score is reported and the EQ-5D Index score was calculated by converting health state scores into a weighted health state index according to a United Kingdom population-based algorithm. The possible values for the EQ-5D Index score range from −0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), on a scale where 1 represents the best possible health state.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D index assessment.||units on a scale||Standard Deviation|Mean
38464|NCT01473563|Secondary|Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline in EQ-5D VAS is reported.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D VAS assessment.||units on a scale||Standard Deviation|Mean
38496|NCT01473160|Primary|Number of Participants With Corrected Visual Acuity of 0.0 or Better|Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.|Up to 16 hours after lens insertion|All enrolled participants||participants|||Number
38497|NCT01472939|Secondary|Time to Maximum Plasma Concentration (Tmax) of SSP-002358||Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.||hours||Full Range|Median
38465|NCT01473563|Primary|Percentage of Participants Who Adhered to Treatment Administration at Home|Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation.|Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)|Intention-to-Treat (ITT) population: Participants who received at least 1 dose of study drug. The number of participants censored was 6, 9, 7, 8, 7, 1, 0, 2, 2, 2, 2, 0, 3, 0, 0, 0, 0, 0, and 1 for Cycles 1 through 19, respectively.||percentage of participants||95% Confidence Interval|Number
38466|NCT01473524|Secondary|Gamma-glutamyltransferase (GGT) Absolute Change From Baseline to Month 12|Gamma-glutamyltransferase (GGT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
38467|NCT01473524|Secondary|Aspartate Aminotransferase (AST) Absolute Change From Baseline to Month 12|Aspartate Aminotransferase (AST) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
38468|NCT01473524|Secondary|Alanine Aminotransferase (ALT) Absolute Change From Baseline to Month 12|Alanine Aminotransferase (ALT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
38469|NCT01473524|Secondary|Direct Bilirubin Absolute Change From Baseline to Month 12|Direct Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||umol/L||Standard Error|Least Squares Mean
38470|NCT01473524|Secondary|Total Bilirubin Absolute Change From Baseline to Month 12|Total Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||umol/L||Standard Error|Least Squares Mean
38471|NCT01473524|Secondary|Alkaline Phosphatase Absolute Change From Baseline to Month 12|Alkaline Phosphatase Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population||U/L||Standard Error|Least Squares Mean
38472|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 Months|Intent-to-Treat Population||percentage of participants|||Number
38473|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 Months|Intent-to-Treat Population||percentage of participants|||Number
38474|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 months|Intent-to-Treat Population||percentage of participants|||Number
38475|NCT01473524|Primary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg OCA vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 months|Intent-to-Treat Population||percentage of participants|||Number
38476|NCT01473394|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate|The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.||Percentage of participants||95% Confidence Interval|Number
38477|NCT01473394|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8|The CGI-S is a clinician-rated scale for assessing the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question “Considering your total clinical experience with this population, how mentally ill is the participant at this time?” on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
38478|NCT01473394|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
38498|NCT01472939|Secondary|Steady State Maximum Plasma Concentration (Cmax) of SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.||pg/ml||Standard Deviation|Mean
38499|NCT01472939|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358|Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.||pg*h/ml||Standard Deviation|Mean
38479|NCT01473381|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.||Percentage of participants||95% Confidence Interval|Number
38480|NCT01473381|Secondary|Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score|The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: “Considering your total clinical experience with this population, how mentally ill is the patient at this time?” The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
38481|NCT01473381|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.||Units on a scale||Standard Error|Least Squares Mean
38482|NCT01473368|Primary|Operational Taxonomic Units|"Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day 0 to Day 21|||units||Standard Deviation|Mean
38483|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21|||percentage of total bacteria||Standard Deviation|Mean
38484|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21|||percentage of total bacteria||Standard Deviation|Mean
38485|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21|||percentage of total bacteria||Standard Deviation|Mean
38486|NCT01473368|Primary|Gastrointestinal Symptoms Response Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 21|Participants analyzed were those with complete data at Day 14||units on a scale||Standard Deviation|Mean
38487|NCT01473368|Primary|Gastrointestinal Symptoms Response Score|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 14|Participants analyzed were those with complete data at Day 14||units on a scale||Standard Deviation|Mean
38488|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 7|||Units on a scale||Standard Deviation|Mean
38489|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 0|Control participants were not assessed at this time point.||units on a scale||Standard Deviation|Mean
38490|NCT01473160|Secondary|Number of Participants With Adequate Lens Fit|Lens fit was assessed by the investigator with a biomicroscope (slit lamp).|Up to 16 hours after lens insertion|All enrolled participants||Participants|||Number
38491|NCT01473160|Secondary|Subjective Vision|"Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, What is the quality of your vision with the lens at present?"|Up to 16 hours after lens insertion|All enrolled participants||Units on a scale||Standard Deviation|Mean
38492|NCT01473160|Secondary|Subjective Comfort|"Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, How comfortable is the lens feeling at present?"|Up to 16 hours after lens insertion|All enrolled participants||Units on a scale||Standard Deviation|Mean
38493|NCT01473160|Primary|Average Ocular Surface Temperature|Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.|Up to 16 hours after lens insertion|All enrolled participants||Degrees Celsius||Standard Deviation|Mean
38500|NCT01472939|Secondary|Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8|PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.|Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
38501|NCT01472939|Secondary|Change From Baseline in Heartburn-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of days||Standard Error|Least Squares Mean
38502|NCT01472939|Primary|Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of days||Standard Error|Least Squares Mean
38503|NCT01472874|Secondary|Zn Urine||Months 1,2,3,6,9,12 (mean)|||mcg/24hr||Standard Deviation|Mean
38504|NCT01472874|Secondary|Zn Urine||Pre Treatment (mean)|||mcg/24hr||Standard Deviation|Mean
38505|NCT01472874|Secondary|Cu Urine||Months 1,2,3,6,9,12 (mean)|||mcg/24hr||Standard Deviation|Mean
38506|NCT01472874|Secondary|Cu Urine||Pre Treatment (mean)|||mcg/24hr||Standard Deviation|Mean
38507|NCT01472874|Primary|Cu Serum||Months 1,2,3,6,9,12 (mean)|||mcg/24h||Standard Deviation|Mean
38508|NCT01472874|Primary|Cu Serum||Pre Treatment (mean)|||mcg/24h||Standard Deviation|Mean
38509|NCT01472874|Secondary|Albumin||Months 1,2,3,6,9,12 (mean)|||g/dL||Standard Deviation|Mean
38510|NCT01472874|Secondary|Albumin||Pre Treatment (mean)|||g/dL||Standard Deviation|Mean
38511|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Months 1,2,3,6,9,12 (mean)|||international normalized ratio||Standard Deviation|Mean
38512|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Pre Treatment (mean)|||international normalized ratio||Standard Deviation|Mean
38513|NCT01472874|Primary|ALT|Alanine transaminase|Months 1,2,3,6,9,12 (mean)|||U/L||Standard Deviation|Mean
38514|NCT01472874|Primary|ALT|Alanine transaminase|Pre Treatment (mean)|||U/L||Standard Deviation|Mean
38515|NCT01472835|Secondary|Satisfaction|5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.|1 day|||units on a scale||Standard Deviation|Mean
38516|NCT01472835|Secondary|Oswestry Disability Index|Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability|1-month|||units on a scale||Standard Deviation|Mean
38517|NCT01472835|Secondary|Procedure-related Pain Score|0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable|1 day|||units on a scale||Standard Deviation|Mean
38518|NCT01472835|Secondary|Pain Score|0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.|1-month|||units on a scale||Standard Deviation|Mean
38519|NCT01472835|Primary|Pain Score|pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable|through 6 hours after injection|||units on a scale||Standard Deviation|Mean
38520|NCT01472822|Secondary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
38521|NCT01472822|Secondary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||ng/ml||Standard Deviation|Mean
38522|NCT01472822|Secondary|Changes in Hs-CRP(High Sensitivity C-reactive Protein)|hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/L||Standard Deviation|Mean
38523|NCT01472822|Secondary|Changes in Lysholm Index Score|"Lysholm index score total score (score 0–100) was measured in study visit 1(0 week) and visit 3(12 week).~The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best)."|12 weeks|per protocol analysis||units on a scale(0-100)||Standard Deviation|Mean
38524|NCT01472822|Primary|Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score|"WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0–96) was measured in study visit 1(0 week) and visit 3(12 week).~The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst)."|12 weeks|per protocol analysis||Score||Standard Deviation|Mean
38525|NCT01472432|Secondary|iNOS|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue|||||
38526|NCT01472432|Secondary|VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form)|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue|||||
38527|NCT01472432|Secondary|VEGF|The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor.|3 months|||arbitrary units||Inter-Quartile Range|Median
38528|NCT01472432|Secondary|HIF-1α|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor.|3 months|||arbitrary units||Inter-Quartile Range|Median
38531|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0 to infinity)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to infinity for efavirenz.||h*ug/mL||Standard Deviation|Mean
38532|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t) for efavirenz.||h*ug/mL||Standard Deviation|Mean
38533|NCT01472380|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the maximum concentration (Cmax)for efavirenz.||ug/mL||Standard Deviation|Mean
38534|NCT01472341|Primary|Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline|Participants with fasting plasma insulin and glucose concentration assessments at baseline.||Percentage Beta Cell Function||Standard Deviation|Mean
38535|NCT01472341|Primary|Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years|Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline and Year 4|Participants who had laboratory parameters at Baseline and at Year 4.||PI/I||Standard Deviation|Mean
38536|NCT01472341|Primary|Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5.|Baseline and 4 years|Participants who had laboratory parameters at Baseline and at Year 4.||Percentage of Beta Cell Function||Standard Deviation|Mean
38537|NCT01472289|Secondary|Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test|Subjects were analyzed to see if they were able to walk any distance and the distance covered by patients in 6 minutes was measured to assess the functional changes from baseline. The American Thoracic Society has issued guidelines for the 6-minute walk test (6 MWT). The 6 MWT is safe, easy to administer, well tolerated, and reflects activities of daily living.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Participants|||Number
38538|NCT01472289|Secondary|Clinical Evaluation for the Presence of Ulcer and/or Gangrene in the Affected Limb From Baseline to 12 Months|Evaluation of the integument for ulceration, gangrene and other skin changes in the affected limb was performed at baseline and follow-up visits at 1 month, 3 months, 6 months, and 12 months.The ulceration and gangrene in the affected limb of the subjects was evaluated by visual clinical inspection.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Participants|||Number
38539|NCT01472289|Secondary|Change in Rest Pain and Intermittent Claudication Assessment From Baseline to 12 Months|"Rest pain is a burning sensation felt at rest, usually in the skin of the foot. It is a symptom of critical ischemia due to severe, chronic, and occlusive peripheral arterial disease (PAD). While, Intermittent Claudication is a crampy leg pain that occurs during exercise, especially walking. The pain is due to the insufficient blood flow in the legs (caused by blocked arteries). Intermittent claudication is the most prominent symptom of PAD.~Both Rest Pain assessment and Intermittent Claudication assessment was performed through Visual Analog Scale or Visual Analogue Scale (VAS). VAS is a psychometric (self-report) response scale that ranges from 0 to 10, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain."|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||scores on a scale||Standard Deviation|Mean
38567|NCT01471574|Secondary|Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Percentages calculated as number of responders/number who received treatment.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy. Here 'n' signifies number of participants evaluable at the specified time-point.||Percentage of participants||95% Confidence Interval|Number
38540|NCT01472289|Secondary|Measurement of Change in Transcutaneous Oxygen Pressure (TcPO2) From Baseline to 12 Months|TcPO2 was used to assess the partial pressure (tension) of oxygen in the capillaries of tissues of lower limbs. It was measured by applying a special set of electrodes to the skin. These electrodes contain photoelectric sensors capable of detecting the specific wavelengths of radiation emitted by oxygenated versus reduced hemoglobin.|Baseline, 1, 3, 6 and 12 months|The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||mmHg||Standard Deviation|Mean
38541|NCT01472289|Secondary|Measurement of Mean Change in Ankle Brachial Index From Baseline to 12 Months|ABI was used to provide a measure of blood flow in the lower limbs. It is the ratio of the blood pressure in the lower limbs to the blood pressure in the upper limbs. Compared to the upper limb, lower blood pressure in the lower limb is an indication of blocked arteries (peripheral vascular disease). The ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. ABI test was performed at baseline, 1 month, 3 months, 6 months, and 12 months.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Ratio||Standard Deviation|Mean
38542|NCT01472289|Secondary|Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months|Measurement of blood supply facilitated by the formation of collateral blood vessels assessed by CT angiography after the procedure.|Baseline and 12 month|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).||Number of Vessels||Standard Deviation|Mean
38543|NCT01472289|Primary|Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration|The Primary objective of this study was to determine the safety of intramuscular administration of concentrated autologous BMMNCs harvested, and processed using the Res-Q 60 technology (a point-of-care system). Safety measurements included close vigilance for major limb amputation free survival at 1, 3, 6 and 12 months post BMMNCs administration and stringent reporting of AEs and SAEs.|1, 3, 6 and 12 Months|All the safety end points in the study were analyzed on the ITT population. Out of 17 subjects, adverse events were reported for seven subjects. Of the seven subjects, three underwent major amputation, two reported minor amputation, and two died due to cardiac arrest (unrelated death). Furthermore, major limb amputation free survival rate was 14.||participants|||Number
38544|NCT01472185|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
38545|NCT01472185|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at time [T] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
38546|NCT01472185|Secondary|Percentage of Participants With HbA1c < 7% at Week 24||Week 24|Participants in the Full Analysis Set with Baseline HbA1c ≥ 7% and available data were analyzed.||percentage of participants|||Number
38547|NCT01472185|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Deviation|Mean
38548|NCT01472185|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding subjects with major eligibility violations and analyzed based on the randomized treatment regardless of actual treatment received) with available data were analyzed.||percent of HbA1c in blood||Standard Deviation|Mean
38549|NCT01471782|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α) and interferon gamma (IFN-ɣ) using cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the lower limit of quantification (LLOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.|Cycle 1 and 2 day 1 (prior to infusion, 2 and 6 hours after infusion start), day 2 and day 3.|Phase 1 full analysis set participants with available data||pg/mL||Standard Deviation|Mean
38550|NCT01471782|Secondary|Number of Participants Who Developed Anti-blinatumomab Antibodies|Antibodies to blinatumomab were detected using an electrochemiluminescence (ECL)-based assay.|Predose up until 30 days after last dose of study medication; median treatment duration was 28 days.|Full analysis set||participants|||Number
38551|NCT01471782|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant During Blinatumomab Induced Remission|The percentage of participants who received allogeneic hematopoietic stem cell transplantation (HSCT) while in remission due to treatment with blinatumomab during the first two cycles, and received no further anti-leukemic medication before HSCT.|Up to the data cut-off date of 12 January 2015; Maximum duration on study was 24 months in phase 1 and 15 months for phase 2.|Full analysis set||percentage of participants||95% Confidence Interval|Number
38552|NCT01471782|Secondary|Relapse-free Survival|"Relapse-free survival (RFS) was assessed for participants who achieved a complete remission during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.~Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission||months||95% Confidence Interval|Median
38553|NCT01471782|Secondary|Overall Survival|"Overall survival (OS) was measured for all participants from the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive. For patients who withdrew their informed consent only information until the date of withdrawal was analyzed.~Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.6 months for phase 2.|Full analysis set||months||95% Confidence Interval|Median
38554|NCT01471782|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured only for participants in remission and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.~Hematological relapse is defined as the proportion of blasts in bone marrow > 25% following documented remission, or extramedullary relapse.~Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission||months||95% Confidence Interval|Median
38555|NCT01471782|Secondary|Steady State Concentration of Blinatumomab|"Blinatumomab serum concentrations were quantified in all patients during the first 2 treatment cycles in the phase 1 part of the study only. Blinatumomab concentrations were quantified using a validated bioassay, the lower limit of quantification was 50 pg/mL. Steady state serum concentration (Css) was presumed on day 1, approximately 5 half-lives after the start of the IV infusion.~The steady state serum concentration reported is the mean of the observed concentrations collected after during cycles 1 and 2."|Cycles 1 and 2 during the IV infusion on day 3 (at least 48 hours after start of infusion) and days 8, 15 and 22 (steady state) and day 29 at End of Infusion (EoI) and 2, 4, and 8 hours after EoI for ages ≥ 2 years.|Phase 1 participants with available blinatumomab concentration data||pg/mL||Standard Deviation|Mean
38556|NCT01471782|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of adverse events (AEs) was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03 and according to the following:~Grade 1 - Mild adverse event; Grade 2 – Moderate adverse event; Grade 3 – Severe and undesirable adverse event; Grade 4 - Life-threatening or disabling adverse event; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days|Full analysis set||participants|||Number
38557|NCT01471782|Primary|Percentage of Participants With Complete Remission in the First Two Cycles|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central laboratory. Complete remission (CR) was defined as~M1 bone marrow (bone marrow blasts < 5%)~No evidence of circulating blasts or extra-medullary disease~Complete remission includes participants with incomplete recovery of peripheral blood counts."|Cycles 1 and 2 (12 weeks)|The full analysis set includes all participants who received any infusion of blinatumomab.||percentage of participants||95% Confidence Interval|Number
38558|NCT01471782|Primary|Phase I: Number of Participants With Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) was defined as one or fewer out of 6 participants experiencing a dose limiting toxicity (DLT) or the maximum administered dose (MAD).~A dose limiting toxicity is any Grade ≥ 3 adverse event related to study drug, Grade 3 fatigue, headache, insomnia, fever, hypotension or infection were not considered dose limiting toxicities. Laboratory parameters of Grade ≥ 3 but not considered as clinically relevant and/or responding to routine medical management, thrombocytopenia, leukopenia (including neutropenia and lymphopenia), and anemia were not considered dose limiting toxicities."|Cycle 1, 28 days|Participants in the Phase 1 dose evaluation/escalation part of the study||participants|||Number
38559|NCT01471691|Secondary|Total Number of Ranibizumab Injections||month 12||||||
38560|NCT01471691|Secondary|Excess Foveal Thickness||Month 6 and 12||||||
38561|NCT01471691|Secondary|Percentage of Patients With CFT Less Than 300um||Month 6 and 12||||||
38562|NCT01471691|Secondary|Change in Mean Best Corrected Visual Acuity From Baseline||months 1-12||||||
38563|NCT01471691|Secondary|Mean Change From Baseline in Center Point Thickness||months 1-12||||||
38564|NCT01471691|Primary|Mean Change From Baseline BCVA|Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.|Baseline to month 6|||Letters (ETDRS chart)||Standard Deviation|Mean
38565|NCT01471626|Primary|Quality of Polysomnographic Recordings|Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.|1 week|||percentage of recording failure|||Number
38566|NCT01471574|Secondary|Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation|Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy.|From Day 1 to 7 days post last dose of study treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study drug.||Participants|||Number
38613|NCT01470170|Primary|Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3|After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||second||Standard Deviation|Mean
38568|NCT01471574|Secondary|Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL|Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.|End of treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study therapy||Percentage of participants||95% Confidence Interval|Number
38569|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.||Percentage of participants|||Number
38570|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.||Percentage of participants|||Number
38571|NCT01471574|Primary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy.||Percentage of participants||95% Confidence Interval|Number
38572|NCT01471379|Secondary|Dose Related Incremental Benefit in Pain Reduction Based on VAS|The investigator was looking to see if, for group A, when increased from 50 mg BID to 100 mg BID there is significant improvement of pain scores i.e. 30% pain reduction, and for group C, if there was significant improvement of pain scores when switched from placebo to 50 mg BID of Milnacipran|12 Weeks|||percentage of participants|||Number
38573|NCT01471379|Secondary|Treatment Efficacy Questionnaire (TEQ)|Treatment Efficacy Questionnaire is a measure of treatment effectiveness. The score ranges from 1 to 48, 1 is minimum score and 48 is the maximum score. The investigators was looking to see if the Milnacipran treatment groups have a higher proportion of subjects with significant improvement in efficacy, judged as a TEQ score of >28, compared to placebo group.|Twelve Weeks|Only one subject was enrolled and was analyzed even though subject did not complete the study.||percentage of subject with score >28|||Number
38574|NCT01471379|Secondary|Subject Self Reported Adequate Relief of Pain|The study sought to determine if the Milnacipran arms had a greater proportion of adequate relief over the placebo group. Subjects were asked to answer ‘yes’ or ‘no’ as to whether or not they had adequate relief of pain due to irritable bowel syndrome.|Twelve Weeks|||percentage of participants|||Number
38575|NCT01471379|Secondary|Quality of Life ( IBS-QOL)|After six weeks of treatment with Milnacipran, treatment groups were compared with placebo for clinically significant improvement in IBS-QOL. 11 point reduction in IBS-QOL compared to baseline was considered as clinically significant improvement.|Six Weeks||||||
38576|NCT01471379|Primary|Pain Response|Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain before the beginning of the study, at 6 weeks of treatment and at the end visit i.e. 10 weeks. Ideally, VAS would have been administered at 12th week; however, subject was terminated at 10th week visit. More than >30% relief in pain would have been considered better outcome.|Twelve Weeks|||participants|||Number
38577|NCT01471197|Secondary|Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study.|Day 1 to Date of last patient, last visit, approximately 7 months after study started.|All participants who received at least one dose of study drug.||participants|||Number
38578|NCT01471197|Secondary|Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants|Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose.|Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.|All participants who were randomized and treated with at least one dose of either study drug.||participants|||Number
38614|NCT01470170|Primary|Propofol Dose Needed to Reach Conscious Level OAAS-3|After the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||mg||Standard Deviation|Mean
39478|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 8 (week 4)||||||
38579|NCT01471197|Primary|Overall Survival of Participants During the Study - All Treated Participants|Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.|Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started|All participants who received at least one dose of either study drug.||participants|||Number
38580|NCT01471171|Secondary|Change From Baseline in Intensity of Dyspnoea|Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.||Units on a scale||Standard Error|Least Squares Mean
38581|NCT01471171|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)|Change from baseline in trough IC after 3 weeks of treatment|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.||Litres||Standard Error|Least Squares Mean
38582|NCT01471171|Primary|Change From Baseline in Endurance Time (Seconds)|Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.||Seconds||Standard Error|Least Squares Mean
38583|NCT01471041|Secondary|Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide|Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide|6 months|||participants|||Number
38584|NCT01471041|Primary|Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis|Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.|3 months|||participants|||Number
38585|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the Second Dose.|"The pharmacokinetic profile of Darbe will be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. A second dose of Darbe will be given at 7 days of age, and serum drug levels will be obtained at 12, 18, 24, and 36 hours post second dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 36 hours after second dose|||AUC (h*mU/L)||Inter-Quartile Range|Median
38586|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the First Dose During Cooling|"The pharmacokinetic profile of Darbe wil be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. Serum levels will be drawn at 4,12, 18, 24, 36, 60, and 72 hours post initial dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 72 hours after first dose|||AUC (h*mU/L)||Inter-Quartile Range|Median
38587|NCT01471015|Secondary|Number of Participants With Adverse Events.|"Potential adverse events such as (but not limited to) alterations in blood pressure, secondary infections, neutropenia, thrombotic/vascular events, hematologic events (platelets, Hct level, polycythemia), and hepatic/renal function that are outside of normal range for the study population.~Complications associated with HIE or cooling therapy will not be considered an AE for this study. AEs reported to be associated with cooling include: bleeding/thrombosis, persistent pulmonary hypertension of the newborn (PPHN), skin changes, arrhythmia, and persistent acidosis."|30 days or until hospital discharge|||participants|||Number
38588|NCT01470859|Secondary|Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).|"Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved.~The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)"|twice, at 10 weeks(V2) and 1 year(V5)|||participants|||Number
38589|NCT01470859|Secondary|Hoehn&Yahr (H&Y) Staging|"The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe.~The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5)."|twice baseline and 1 year|||units on a scale||Standard Deviation|Mean
38590|NCT01470859|Secondary|Parkinson's Disease Questionnaire (PDQ39)|"The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).~PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe."|twice baseline and 1 year|||units on a scale||Standard Deviation|Mean
38591|NCT01470859|Secondary|Unified Parkinson's Disease Rating Score (UPDRS II, III)|baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.|three times: baseline, 10 weeks, 1 year|||units on a scale||Standard Deviation|Mean
38592|NCT01470859|Primary|Longitudinal Change of Brain Network Activity|"The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).~The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1."|twice, baseline and 1 year after baseline|||Z-score in PDRP||Standard Deviation|Mean
39389|NCT01460732|Primary|Awake Diastolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
38593|NCT01470651|Secondary|Fatigue Severity Scale (FSS)|Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. “fatigue interferes with my work, family or social life”). Response format is a 7-point Likert scale of agreement with a 1-week time frame. Total score is the sum of item scores and ranges from 9 to 63 points, with higher scores indicating greater fatigue. A score greater than 40 is considered to be a clinically significant level of fatigue. Scores on the scale correlate highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil.|Biweekly for the first month, monthly thereafter|||FSS score (out of 63)||Standard Deviation|Mean
38594|NCT01470651|Primary|Adherence to Medications Form|The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil.|HCV medication adherence reported at 12 weeks|Not all patients were given all medications, subjects are not factored in if they were not told to take a given drug.||Percentage of doses missed||Standard Error|Mean
38595|NCT01470469|Primary|Change From Baseline in ECG QTcF Interval at up to 12 Weeks|The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||Standard Deviation|Mean
38596|NCT01470469|Primary|Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks|QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||msec||Standard Deviation|Mean
38597|NCT01470469|Primary|Change From Baseline in Weight at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||kg||Standard Deviation|Mean
38598|NCT01470469|Primary|Change From Baseline in Height at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||cm||Standard Deviation|Mean
38599|NCT01470469|Primary|Change From Baseline in Pulse Rate at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
38600|NCT01470469|Primary|Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
38601|NCT01470469|Primary|Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
38602|NCT01470417|Secondary|Prognostic Risk Stratifiers|Evaluate key biochemical, radiographic, and pathologic factors that may impact response to neoadjuvant therapy|5 years||||||
38603|NCT01470417|Secondary|Quality of Life Analysis|Evaluate quality of life as related to treatment and toxicity.|2 years||||||
38604|NCT01470417|Secondary|Treatment Associated Toxicity|Evaluate treatment related acute and long-term toxicity|5 years||||||
38605|NCT01470417|Secondary|90 Day Post-operative Mortality|Evaluate mortality in the first 90 days after surgery|90 days after surgery|||participants|||Number
38606|NCT01470417|Secondary|Overall Survival|Survival status 5 years after treatment|5 years after treatment||||||
38607|NCT01470417|Secondary|Disease Free Survival|Length of disease free survival after treatment|5 years||||||
38608|NCT01470417|Primary|Pathologic Downstaging and Margin Status|Pathologic stage and margin status after resection. Pathologic downstaging was determined my looking at the rate of R0 (all residual tumor removed during surgery) vs R1 (microscopic tumor present at the resection margin per pathology) resections.|At the time of surgery after neoadjuvant therapy|Subjects who had a surgical resection of their primary tumor were included in this analysis.||participants|||Number
38609|NCT01470417|Primary|Radiographic Response Rate|Evaluate radiographic response of the measurable disease with repeat imaging at 4 - 8 weeks after therapy. Measurable disease was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. Per RECIST v1.1 in target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >20% growth in the sum of the longest diameter or target lesions or appearance of new lesions; Stable Disease (SD), change in sum of longest diameter of target lesions does not meet criteria for PR or PD. The number of subjects experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) is reported.|4 - 8 weeks after neoadjuvant therapy|All subjects enrolled in the study were included in this analysis.||participants|||Number
38610|NCT01470417|Primary|Biochemical Response Rate|Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values.|4 - 8 weeks after neoadjuvant therapy|The seven subjects included in this analysis had CA19-9 testing performed at baseline and again prior to surgery. Pre-operative CA19-9 testing was not performed for one subject so they were not included in this analysis nor were two subjects who were found to have progressive disease prior to completing neoadjuvant therapy.||U/mL||Full Range|Mean
38611|NCT01470170|Secondary|Hypotension|Check the frequency of hypotension episode during induction, procedure and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||participants|||Number
38612|NCT01470170|Secondary|Hypoxemia|Check the frequency of hypoxemia episode during induction, procedure, and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||participants|||Number
39390|NCT01460732|Primary|Awake Systolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks|||mmHg||Standard Deviation|Mean
38615|NCT01470170|Primary|Effect Site Concentration When Conscious Level Reaches OAAS-3|After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours|||ug/ml||Standard Deviation|Mean
38616|NCT01470144|Secondary|Exposure Duration|Duration of exposure to EFI|Study start to end of treatment|||year||Full Range|Median
38617|NCT01470144|Primary|Treatment-emergent Adverse Events||Up to 24 hours post treatment|All patients who received at least one dose of EFI||Number of patients|||Number
38618|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38619|NCT01470118|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38620|NCT01470118|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38621|NCT01470118|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38622|NCT01470118|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38623|NCT01470118|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38624|NCT01470118|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38625|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 0 Hour 16|Intent-to-Treat: All randomized subjects||Scores on a Scale||Standard Deviation|Mean
38626|NCT01469819|Secondary|Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.||Measured at baseline and 2 weeks after baseline.|||participants|||Number
38627|NCT01469819|Secondary|Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day.||Measured at baseline and 2 weeks after baseline.|Number of Bowel Movements per week||number per week||Standard Error|Mean
38628|NCT01469819|Secondary|Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.|Changes in Time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week.|Measured at baseline and 2 weeks after baseline.|||Hours||Standard Error|Mean
38629|NCT01469819|Secondary|Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).||Measured at baseline and 2 weeks after baseline|||number per week||Standard Error|Mean
38785|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
38630|NCT01469819|Primary|Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day.|The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.|Measured at baseline and 2 weeks after baseline.|||Hours||Standard Error|Mean
38631|NCT01469715|Primary|Absolute Relative Difference (ARD)|"ARD=100*(G_sensor-G_reference)/G_reference~Calculated for when patient's G_ref was Normal (70-180 mg/dl), Hyperglycemic (>180 mg/dl) and Hypoglycemic (<70 mg/dl)~The study data includes 208 paired sensor-YSI plasma glucose readings (G_reference) for each GBP CGM sensor (G_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as median and mean absolute deviations and median and mean absolute relative deviation and Point CG-EGA, as well as dynamic parameters, such as warm-up time, trend accuracy (Rate CG-EGA), and sensor lag."|25.5 hours|||percentage of error|||Number
38632|NCT01469637|Primary|Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ug/ml||Standard Deviation|Mean
38633|NCT01469637|Primary|Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||h*ug/ml||Standard Deviation|Mean
38634|NCT01469546|Secondary|Median Progression-Free Survival (PFS)Time|To evaluate PFS time in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.||months||95% Confidence Interval|Number
38635|NCT01469546|Secondary|Number of Patients That Experienced Grade 3 or 4 Toxicities|The number of patients who develop these while on treatment and for 28 days after cessation of axitinib, and graded in severity per CTCAE v. 3.0 and as described in the protocol. According to the CTCAE v. 3.0, grade 3 toxicities are severe and grade 4 toxicities are life-threatening or disabling.|28 Days Post Treatment|All patients that received at least one dose of treatment were analyzed for toxicity.||patients|||Number
38636|NCT01469546|Secondary|Number of Participants Who Achieved Complete Response, Partial Response or Stable Disease|"To determine the disease control rate (complete response+partial response+stable disease), in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.~Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) will be used.~Complete Response is defined as the disappearance of all tumor for a period of one month.~Partial Response is defined as a 30% or more decrease in the sum of the longest diameters (LD) of all measured lesions without any evidence of progression of any lesion or the appearance of any new lesion for a period of one month.~Stable Disease is defined as any change in measurable disease which is less than the criteria for partial remission or progression without any evidence of new lesions and persisting for at least 2 evaluations or 2 months."|2 years|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.||participants|||Number
38637|NCT01469546|Primary|Percentage of Patients Alive and Free of Progression at 6 Months|To determine the 6-months progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.||percentage of patients|||Number
38638|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|Within-subject change to absolute FEF 25-75 month 1 vs. 0. FEF 25-75 was measured 14-35 days after the start of months 1|Baseline, month 1|||Liter||Inter-Quartile Range|Median
38639|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|Within-subject change to absolute FEF 25-75 month 5 vs 0. FEF 25-75 was measured 14-35 days after the start of months 5|Baseline, month 5|||Liter||Inter-Quartile Range|Median
38640|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 5 vs 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in theTotal Score. The SGRQ was completed 14-35 days after the start of month 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.||units on a scale||Inter-Quartile Range|Median
38681|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))||10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng/mL||Standard Deviation|Geometric Mean
38641|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 1 vs. 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in the Total Score. The SGRQ was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28) time-points.||units on a scale||Inter-Quartile Range|Median
38642|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5.|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 5 vs 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 and 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.||units on a scale||Inter-Quartile Range|Median
38643|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 1 vs. 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28)||units on a scale||Inter-Quartile Range|Median
38644|NCT01469364|Secondary|Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC).|The study team is measuring the change in neutrophils AFTER treatment. They will compare a SOC BAL taken after AZLI with the BAL taken within 90 days of AZLI initiation (pre or baseline measure). The post AZLI BAL measurement time range is 15 days after first course of AZLI up to last day of the 3rd and final course of AZLI (over a period of 5 consecutive months).|Baseline - defined as a within 90 days of enrollment and After Treatment (5 months)|Participants with paired SOC bronchoalveolar lavage fluid cell differential counts performed within 90 days of AZLI month 1 (baseline timepoint) and >=15 days after AZLI dose 1 through the completion of dose 3 (study month 5) were included in the analysis (n=5).||mean percentage of neutrophils||Standard Deviation|Mean
38645|NCT01469364|Secondary|Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid.|Microbiology data was collected when performed for SOC purposes on BAL or sputum samples. Baseline and 1 month value represents the culture final report value (0,1+, 2+, 3+, 4+) of Pseudomonas aeruginosa. A value of zero represents no Pseudomonas aeruginosa sputum or bronchoalveolar fluid. A value of 4 represents high amounts of Pseudomonas aeruginosa sputum or bronchoalveolar fluid.|Baseline, month 1|The statistical analysis was unable to be performed due to insufficient number of paired observations. Only 9 of 30 enrolled had baseline microbiology data, 3 were cultured positive for Pseudomonas Aeruginosa. Only 1 of the 3 had a subsequent SOC BAL sample collected. Therefore, only raw data is entered for the one subject.||culture value of Pseudomonas aeruginosa|||Number
38646|NCT01469364|Secondary|Change in HRQOL Off AZLI Therapy.|This will be compared to study month 0 (baseline), when obtained at standard of care visit (SOC)|At study months 2 or 4|Partial data for this outcome measure was collected on 4 participants and due to not having a complete data set the analyzation was not completed.|||||
38647|NCT01469364|Secondary|Change in FEV1 Off AZLI Therapy|This will be compared to study month 0 (baseline, when obtained as standard of care (SOC).|At Study Months 2 and 4|Partial data for this outcome measure was collected on 4 participants and due to not having complete data set analyzation was not completed.|||||
38648|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 5 vs 0.|Baseline, month 5|||Liter||Inter-Quartile Range|Median
38649|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 1 vs. 0. FEV1 was measured 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|||Liter||Inter-Quartile Range|Median
38650|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38682|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))||0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning|||ng/mL||Standard Deviation|Geometric Mean
38651|NCT01469234|Secondary|Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point|"The individual symptom score for Nasal Congestion was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38652|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Eyes was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38653|NCT01469234|Secondary|Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Water Eyes was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38654|NCT01469234|Secondary|Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point|"The individual symptom score for Sneezing was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38655|NCT01469234|Secondary|Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Nose was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38656|NCT01469234|Secondary|Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Runny Nose was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38657|NCT01469234|Primary|Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)|The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."||units on a scale||Standard Deviation|Mean
38658|NCT01469182|Secondary|Number of Participants Who Discontinued Due to Treatment-emergent AEs|Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 28|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38659|NCT01469182|Secondary|Number of Participants Reporting Skin Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38660|NCT01469182|Secondary|Number of Participants Reporting Nasal Passage Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38661|NCT01469182|Secondary|Number of Participants Reporting Eye Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38662|NCT01469182|Secondary|Number of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38663|NCT01469182|Secondary|Number of Participants Reporting Throat Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38664|NCT01469182|Secondary|Number of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38665|NCT01469182|Secondary|Number of Participants Reporting Oral Pruritus.|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment||Participants|||Number
38666|NCT01469182|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 35|All subjects as treated (ASAT) consisting of participants who received at least one dose of study treatment||Participants|||Number
38667|NCT01469065|Secondary|Change From Baseline in Fasting Lipid Parameters at Day 14 and 16|Baseline for fasting triglycerides (TG) was defined as the average of the Day -1 (hour -48), Day 0 (hour -24), and Day 1 pre-dose (hour 0) measurements. Baseline for fasting total cholesterol (TC), cholesterol (high-density lipoprotein (HDL)), and cholesterol (low-density lipoprotein (LDL)) was defined as the Day 1 pre-dose (hour 0) measurement.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 on Day 1 for TG and Hour 0 (before morning dose) on Day 1 for TC, HDL, and LDL; 48 hours after morning dose on Day 16 for TG and Hour 0 (before morning dose) on Day14 for TC, HDL, and LDL|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."||mg/dL||Standard Deviation|Mean
38668|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of C-peptide from Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) was calculated based on 8 C-peptide measurements at prespecified timepoints using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||ng*hr/mL||Standard Deviation|Mean
38669|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of Insulin from Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) was calculated based on 8 insulin measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||milliUnit*hour/liter (mU*hr/L)||Standard Deviation|Mean
38722|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2||||||
38670|NCT01469065|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The average of the Day -1 (hour -48), Day 0 (hour -24) and Day 1 pre-dose (hour 0) measurements was the baseline for fasting plasma glucose (FPG) analyses.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 (before morning dose) on Day 1; hour 0 (before morning dose of each day) on Days 1, 2, 3, 6, and 10; and 24 hours after Day 14 morning dose on Day 15|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."||mg/dL||Standard Deviation|Mean
38671|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area under the curve of glucose from time 2 to 6 hours post morning dose (Glucose AUC(2-6)) was calculated based on 8 glucose measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||mg*hr/dL||Standard Deviation|Mean
38672|NCT01469065|Secondary|Change From Baseline (Day -2) in Mean Daily Glucose at Day 13|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day.|Baseline: hours -72, -70, -68, -66, -62, -60, -57, and -54 on Day -2 (Day 1 morning dose was hour 0); Day 13: 0 (before morning dose), 2, 4, 6, 10, 12, 15 and 18 hours after Day 13 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||mg/dL||Standard Deviation|Mean
38673|NCT01469065|Secondary|Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532|Maximum Observed Plasma Concentration of PF-04991532 after Morning Dose Administration (Cmax(AM)) divided by dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng/mL/mg||Standard Deviation|Geometric Mean
38674|NCT01469065|Secondary|Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532|Area under the curve from time zero to 24 Hours Postdose (AUC24) divided by total daily dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng*hr/mL/mg||Standard Deviation|Geometric Mean
38675|NCT01469065|Secondary|Observed Accumulation Ratio of Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Rac, Cmax(AM))|Maximum observed plasma concentration of PF-04991532 after morning dose administration (Cmax(AM)) of Day 14 divided by Cmax(AM) of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Geometric Mean
38676|NCT01469065|Secondary|Observed Accumulation Ratio of Area Under the Curve From Time Zero to 10 Hours Postdose of PF-04991532 (Rac)|Area under the curve from time zero to 10 hours postdose of PF-04991532 (AUC10) of Day 14 divided by AUC10 of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Geometric Mean
38677|NCT01469065|Secondary|Apparent Oral Clearance (CL/F) of PF-04991532|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 and Day 14: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10 (before evening dose), 10.5, 11, 12, 13, 15, 18 and 24 hours after morning dose|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||milliliter/minute (mL/min)||Standard Deviation|Geometric Mean
38678|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM))|Time was computed as post morning dose.|10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||hour||Full Range|Median
38679|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM))||0 (predose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||hour||Full Range|Median
38680|NCT01469065|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532||Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
38723|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2||||||
39479|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 7 (week 4)||||||
38683|NCT01469065|Secondary|Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 10 hours post morning dose.|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||ng*hr/mL||Standard Deviation|Geometric Mean
38684|NCT01469065|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours post morning dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
38685|NCT01469065|Primary|Change From Baseline (Day -1) in Mean Daily Glucose at Day 14|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.|Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
38686|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||hr||90% Confidence Interval|Geometric Mean
38687|NCT01469052|Secondary|Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||L/hr||90% Confidence Interval|Geometric Mean
38688|NCT01469052|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||ng*hr/mL||90% Confidence Interval|Geometric Mean
38689|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||hr||90% Confidence Interval|Mean
38690|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.||ng/mL||90% Confidence Interval|Geometric Mean
38691|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||hr||Standard Deviation|Mean
38692|NCT01469052|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||Liter/hr (L/hr)||95% Confidence Interval|Geometric Mean
38693|NCT01469052|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)]|AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||ng*hr/mL||95% Confidence Interval|Geometric Mean
38786|NCT01467882|Secondary|Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12|This is a lab test to see what percentage of children were returned to normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 9 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
38694|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||hr||Full Range|Median
38695|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug.‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.||Nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
38696|NCT01469052|Primary|Maximum Tolerated Dose (MTD)|"MTD is defined as the dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD). DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity."|Baseline up to Day 28|Analysis population included all enrolled participants who received at least one dose of the study drug.||mg BID|||Number
38697|NCT01469039|Secondary|Clinical Global Impression - Improvement (CGI-I) Scores at Day 85|"The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse."|85 Days|FAS, defined as all randomized subjects who received at least 1 IM dose of study drug and had at least 1 primary efficacy assessment after administration of IM study drug.||participants in category|||Number
38698|NCT01469039|Primary|The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.|Data collected from baseline to day 85|Full Analysis Set (FAS) defined as all randomized subjects who received at least 1 dose of IM study drug and had at least 1 primary efficacy assessment after administration of IM study drug.||units on a scale||Standard Error|Least Squares Mean
38699|NCT01469000|Secondary|Time to Worsening of Symptoms Using the Lung Cancer Symptom Scales (LCSS)||Baseline to Progressive Disease (Estimated Up To 18 Months)||08/2018||||
38700|NCT01469000|Secondary|Change From Baseline in Lung Cancer Symptom Scale (LCSS) Score(Symptom Control)||Baseline to Progressive Disease (Estimated Up To 18 Months )||08/2018||||
38701|NCT01469000|Secondary|Duration of Response (DoR)|DoR was defined as the time from the date of the first CR or PR to the first date of Progressive Disease (PD) ( RECIST 1.1 Criteria) or death from any cause.CR is the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression. Participants not known to have died or to have had progression of disease as of the data-inclusion cut-off date for a particular analysis,duration of tumor response was censored at the date of the participants last tumor assessment prior to that cut-off date.|First Observation of CR or PR to Progressive Disease or Death Due to Any Cause (Up To 30.29 Months)|All randomized participants who received at least 1 dose of drug had evaluable baseline and post baseline data. Participants censored: Gefitinib/Pemetrexed =30, Gefitinib=7||months||95% Confidence Interval|Median
38702|NCT01469000|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) (Disease Control Rate [DCR])|Disease control rate is the percentage of participants with a confirmed CR, PR or SD as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Randomization to Progressive Disease (Up To 31.38 months)|All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline data.||percentage of participants|||Number
38703|NCT01469000|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|ORR is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Partial Response (PR) is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.|Randomization to Progressive Disease (Up to 31.38 Months)|All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline data.||percentage of participants|||Number
38704|NCT01469000|Secondary|Overall Survival (OS)||Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 50 Months)||08/2018||||
38724|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48|||ETDRS letters|Participants|Full Range|Mean
38705|NCT01469000|Secondary|Time To Progressive Disease (TTPD)|TTPD is defined as time from the date of randomization to the first date of disease progression. For each participant who is not known to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, or who has died without progression of disease, TTPD will be censored for that analysis at the date of the participant’s last tumor assessment prior to that cut-off date. TTPD was analyzed twice: (1) excluding clinical progressions of disease (that is,those not defined according to the RECIST version 1.1 criteria ), and (2) including clinical progressions. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to Progressive Disease (Up To 31.38 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =44, Gefitinib=9||months||95% Confidence Interval|Median
38706|NCT01469000|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization to the first date of objectively determined progressive disease or death from any cause, whichever is earlier. The censoring is taken in the following order: If a participant didn't have a complete baseline disease assessment, then the PFS time was censored at the enrollment date, regardless of whether or not objectively determined disease progression or death has been observed for the participant; otherwise, if a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 31.38 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =38, Gefitinib=9||months||95% Confidence Interval|Median
38707|NCT01468818|Secondary|Level of Persistence of the Transferred Cells in Blood|Determine level of transferred cells in the blood following a non-myeloablative lymphodepleting chemotherapy preparative regimen.|Once week and one month after transfer|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 35 subjects was needed to perform an analysis.|||||
38708|NCT01468818|Primary|Objective Response in Patients With Metastatic Melanoma|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 2 Years|||participants|||Number
38709|NCT01468584|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
38710|NCT01468558|Primary|AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg*h/ml||Standard Deviation|Geometric Mean
38711|NCT01468558|Primary|Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Geometric Mean
38712|NCT01468350|Secondary|Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function|"Hand strength as measured by a composite Z-score derived from the grip test, and key, tip and palmar pinch tests~Manual dexterity as measured by the Box and Block Test~Walking speed as measured by the Timed 25 Foot Walk (T25FW)~Gait as measured by gait analysis equipment (to be performed by sites that have the capability to perform it)~For Part B only, subjective impressions of treatment as measured by:~Subject Global Impression (SGI)~Clinician Global Impression (CGI)"|up to 31 days||||||
38713|NCT01468350|Primary|Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)|"Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs)~TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study.~The severity categories of mild, moderate or severe, are defined below:~Mild is defined as causing no limitation of usual activities~Moderate is defined as causing some limitation of usual activities~Severe is defined as causing inability to carry out usual activities"|up to 31 days|Safety Population (Took at least one dose)||participants|||Number
38714|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 48 Compared to Baseline||Baseline and Week 48||||||
38715|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 48 Compared to Baseline||Baseline and Week 48||||||
38716|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 48 Compared to Baseline||Baseline and Week 48||||||
38717|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48||||||
38718|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48||||||
38719|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 2 Compared to Baseline||Baseline and Week 2||||||
38720|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 2 Compared to Baseline||Baseline and Week 2||||||
38721|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 2 Compared to Baseline||Baseline and Week 2||||||
38725|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48|||ETDRS letters|Participants|Full Range|Mean
38726|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2|||ETDRS letters|Participants|Full Range|Mean
38727|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2|||ETDRS letters|Participants|Full Range|Mean
38728|NCT01468337|Primary|Number of Participants Who Withdrew From the Study||Week 48|||participants|||Number
38729|NCT01468337|Primary|Total Number of Non-ocular Adverse Events Related to the Investigational Product||Week 48|||Adverse Events|||Number
38730|NCT01468337|Primary|Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product||Week 48|||Adverse Events|||Number
38731|NCT01468337|Primary|Total Number of Ocular Adverse Events Related to Investigational Product||Week 48|||Adverse Events|||Number
38732|NCT01468337|Primary|Total Number of Severe Ocular Adverse Events Related to the Investigational Product||Week 48|||Adverse Events|||Number
38733|NCT01468233|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population||units on a scale||Standard Error|Least Squares Mean
38734|NCT01468233|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) – at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3||percentage of participants|||Number
38735|NCT01468233|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II||percentage of participants|||Number
38736|NCT01468233|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage||percentage of participants|||Number
38747|NCT01468181|Primary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug||percentage of participants|||Number
38737|NCT01468207|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population||units on a scale||Standard Error|Least Squares Mean
38738|NCT01468207|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) – at worst at Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3||percentage of participants|||Number
38739|NCT01468207|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II||percentage of participants|||Number
38740|NCT01468207|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage||percentage of participants|||Number
38741|NCT01468181|Secondary|Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)|The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HOMA2 data. LOCF was used to impute missing postbaseline values.||percentage of HOMA2||Standard Error|Mean
38742|NCT01468181|Secondary|Change From Baseline in Body Weight||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable body weight data. LOCF was used to impute missing postbaseline values.||kilograms (kg)||Standard Error|Mean
38743|NCT01468181|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable SMBG data. LOCF was used to impute missing postbaseline. values.||mg/dL||Standard Error|Mean
38744|NCT01468181|Secondary|Change From Baseline in Fasting Blood Glucose (FBG)||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable FBG data. LOCF was used to impute missing postbaseline values.||milligrams/deciliters (mg/dL)||Standard Error|Mean
38745|NCT01468181|Secondary|Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%||26 weeks and 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. LOCF was used to impute missing postbaseline values.||percentage of participants|||Number
38746|NCT01468181|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, up to 26 Weeks and up to 52 Weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. Last observation carried forward (LOCF) was used to impute missing postbaseline values.||percentage of HbA1c||Standard Error|Mean
38781|NCT01467882|Secondary|Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat girls, defined as all girls enrolled||ng/L||Standard Deviation|Mean
38782|NCT01467882|Secondary|Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled||IU/L||Standard Deviation|Mean
38748|NCT01468181|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug||percentage of participants|||Number
38749|NCT01468077|Secondary|Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Weeks 4, 8. 12, 20, and 24|ITT Completers||Percentage of Participants|||Number
38750|NCT01468077|Secondary|Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Baseline, Weeks 4, 8, 12, 20, and 24|ITT Completers||scores on a scale||Standard Deviation|Mean
38751|NCT01468077|Secondary|High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits|hsCRP is a marker for inflammation and is measured in milligrams per liter (mg/L). High levels of this protein indicate inflammation in diseases such as RA.|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||mg/L||Standard Deviation|Mean
38752|NCT01468077|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits|ACR90 response is defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers||Percentage of Participants|||Number
38753|NCT01468077|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits|ACR70 response is defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers||Percentage of Participants|||Number
38754|NCT01468077|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits|ACR50 response is defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
38755|NCT01468077|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits|ACR20 response is defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]).|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
38756|NCT01468077|Secondary|DAS28 Score by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Baseline, Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers; n = the number of participants analyzed for the given parameter at the specific visit.||scores on a scale||Standard Deviation|Mean
38757|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
38758|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
38783|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the lower than normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
38759|NCT01468077|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits|Improvement in Rheumatoid Arthritis (RA) disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response High sensitivity C-Reactive Protein (hsCRP), and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score less than (<)3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
38760|NCT01468077|Secondary|Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits|Increased levels of high density lipoproteins (HDL) equal to or greater than (≥)1.5 millimoles per liter (mmol/L), and low density lipoproteins (LDL) ≥4.1 mmol/L, and total cholesterol ≥5.1 mmol/L, are defined according to the Adult Treatment Panel III (ATP-III) guidelines.|Screening and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers||Percentage of Participants|||Number
38761|NCT01468077|Secondary|Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits|"Increased liver enzyme values defined as Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values of >1.5 times, or >3 times, or >5 times over the ULN. Almost none of the participants had increased measurements of AST, thus only values of ALT were presented. None of the participants presented with increased values of ALT above 3 or 5 ULN at any of the visits.~ITT Completers is defined as a subset of the participants in the ITT population who completed all study visits."|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers with liver enzyme datasets for each analyzed visit||Percentage of Participants|||Number
38762|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab for Other Reasons|Participants that stopped the administration of tocilizumab and discontinued the study prematurely due to reasons other than an AE or SAE were analyzed.|Baseline and Weeks, 4, 8, 12, 16, 20, and 24|SAS Population||Percentage of Participants|||Number
38763|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)|All occurrences of participants who received at least 1 infusion of tocilizumab and then stopped tocilizumab infusions due to an AE or SAE were analyzed.|Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24|SAS Population||Percentage of Participants|||Number
38764|NCT01468077|Primary|Percentage of Participants With Any Infusion Reaction|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.|Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20|Safety Analysis Set (SAS) Population: All randomized participants who received at least one infusion of tocilizumab.||Percentage of Participants|||Number
38765|NCT01468012|Primary|Retention in Treatment|The number of participants who completed the 12-week medication phase of the study.|12 weeks|||participants|||Number
38766|NCT01468012|Primary|Cocaine Urine Toxicology|Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation|collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.||||||
38767|NCT01467960|Primary|Detection of Apolipoprotein D|Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)|Baseline|||microg / ml||Standard Deviation|Mean
38768|NCT01467947|Secondary|Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies|Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months|||Subjects|||Number
38769|NCT01467947|Primary|Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies|Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months|||subjects|||Number
38770|NCT01467934|Primary|Fever >= 100.4||8 days|Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.||percentage of participants|||Number
38771|NCT01467882|Secondary|Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat boys, defined as all boys enrolled||percentage of participants|||Number
38772|NCT01467882|Secondary|Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat girls, defined as all girls enrolled||percentage of participants|||Number
38773|NCT01467882|Secondary|Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12||at Months 6 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
38774|NCT01467882|Secondary|Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
38775|NCT01467882|Secondary|Change From Baseline in Growth Velocity at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||cm/year||Standard Deviation|Mean
38776|NCT01467882|Secondary|Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||percentile||Standard Deviation|Mean
38777|NCT01467882|Secondary|Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled||Z-score||Standard Deviation|Mean
38778|NCT01467882|Secondary|Percentage of Children Without Higher Basal LH and Estradiol or Testosterone||at 2 days after second triptorelin injection (Day 171)|AOC Subset is defined as 50% of the population randomly assigned||percentage of participants|||Number
38779|NCT01467882|Secondary|Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||at Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled||percentage of participants|||Number
38780|NCT01467882|Secondary|Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat boys, defined as all boys enrolled||ng/dL||Standard Deviation|Mean
38787|NCT01467882|Primary|Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6|This is a lab test to see what percentage of participants were returned to normal before-puberty levels at Month 6.|Month 6|Intention to treat, defined as all participants enrolled||percentage of participants||95% Confidence Interval|Number
38788|NCT01467713|Secondary|Quality of Life, Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score|Q-LES-Q-SF is a self-administered 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by patients in various areas of daily functioning. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes relative to baseline indicate improved quality of life.|Baseline and Months 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12|Participants from the Full Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy, with available data.||percent of maximum total score||Standard Deviation|Mean
38789|NCT01467713|Secondary|Time From Randomization to Study Withdrawal for Any Reason|The time from randomization to study withdrawal during the 12 month double-blind treatment period. Withdrawal includes pretreatment event/adverse event; liver function test abnormalities; major protocol deviation; lost to follow-up; voluntary withdrawal; study termination; pregnancy; lack of efficacy; participant has a depressive, mania/hypomania or mixed episode; is hospitalized for psychiatric reasons; receives electroconvulsive therapy for bipolar disorder; receives any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes; or any other reason.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy.||days||Standard Error|Mean
38790|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychotropic Medication Change Prescribed for the Treatment of Depression, Mania/Hypomania or Mixed Episodes|The time from randomization to relapse event during the 12 month double-blind treatment period due to any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episode(s).|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
38791|NCT01467713|Secondary|Time From Randomization to Relapse Due to Electroconvulsive Therapy (ECT) Administration|The time from randomization to relapse event during the 12 month double-blind treatment period due to ECT.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
38792|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychiatric Hospitalization for Bipolar Disorder|The time from randomization to relapse event during the 12 months double-blind treatment period due to psychiatric hospitalization for bipolar disorder.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
38793|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mixed Episode|Relapse due to Mixed episode is determined by PI judgement and/or MADRS score ≥16 and YMRS total score ≥16. MADRS is a 10-item scale that measures overall severity of depressive symptoms rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
38794|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania|Relapse due to mania/hypomania is determined by the primary investigator (PI) judgement and/or a YMRS total score ≥16. YMRS is a 11 item scale with four items scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to 12 Month double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
38795|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression From PI Judgement and/or MADRS ≥16|The time from randomization to relapse event during the 12 month double-blind treatment period due to depression, determined by the PI judgement and/or a MADRS score ≥16. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
38861|NCT01467479|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38796|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode|Relapse due to mania/hypomania or mixed episode is determined by any of the following criteria: PI judgment, mania/hypomania [YMRS ≥16], mixed episode [MADRS ≥16 and YMRS ≥16], psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||days||Standard Error|Mean
38797|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression|Relapse due to depression determined by any of the following criteria during the 12-month double-blind treatment period: PI judgment, MADRS ≥16, psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of depressive episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||Days||Standard Error|Mean
38798|NCT01467713|Primary|Time From Randomization to Any Relapse|The time from randomization to relapse over 12 months double-blind treatment period as determined by the Principal Investigator (PI) or defined by any of the following criteria: depression [Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥16]; mania/hypomania [Young Mania Rating Scale (YMRS) total score ≥14]; mixed episode [MADRS score ≥16 and YMRS total score ≥16]; or, whether participant receives psychiatric hospitalization for bipolar disorder, electroconvulsive therapy (ECT) or any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.||Days||Standard Error|Mean
38799|NCT01467700|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS comprises patient-rated items designed to measure the extent to which the subject’s life is impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities, are impaired by his or her symptoms on 10-point visual analogue scales from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. There are verbal descriptors for the points on the scales as well as numerical scores that provide more precise levels of the verbal descriptors. In addition, the SDS addresses the number of days lost and the number of days under-productive due to the symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
38800|NCT01467700|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16 item QIDS-SR16 version is designed to assess the severity of depressive symptoms. The QIDS-SR16 assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition, DSM-IV, to diagnose a major depressive episode. QIDS-SR16 assessment has been used to screen for depression and also to measure symptom severity. This scale is also used to distinguish response from remission, as well as to quantify between group treatments effects in open label and randomized controlled trials. The patient is asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
38801|NCT01467700|Secondary|Percentage of Participants With MADRS Remission at Week 6, With Remission Defined as a MADRS Total Score ≤10|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||percentage of participants|||Number
38802|NCT01467700|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Week 6|"The CGI-S at week 6 relative to Baseline. The CGI-S assesses the clinician's impression of the participant's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
38847|NCT01467505|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38803|NCT01467700|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|6 Weeks|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
38804|NCT01467700|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS total score at week 6 relative to baseline. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analyses with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
38805|NCT01467700|Secondary|Percentage of Participants With MADRS Response at Week 6, With Response Defined as a ≥ 50% Decrease in the MADRS Total Score From Baseline|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||percentage of participants|||Number
38806|NCT01467700|Secondary|Change From Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) Short Form Total Score at Week 6|Q-LES-Q -SF is a self-administered, 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are two global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of total possible score, with higher scores indicating better health status. A positive change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||percent of maximum score on a scale||Standard Error|Least Squares Mean
38807|NCT01467700|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6|The change between MADRS score at week 6 relative to Baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A mixed measures repeated measures (MMRM) model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from full analysis set (FAS), all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.||score on a scale||Standard Error|Least Squares Mean
38808|NCT01467661|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||participants|||Number
38809|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).||percentage of participants|||Number
38848|NCT01467492|Other Pre-specified|Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)||48 weeks|Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.|||||
38973|NCT01466270|Primary|Compliance|Compliance is the percentage of pills taken while on study (based on returned diaries)|24 weeks|Participants who returned pill diaries. Note that some participants did not return diaries so the numbers of participants for this analysis may not agree with the numbers for other analyses.||percentage of pills||Full Range|Mean
38810|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||percentage of participants|||Number
38811|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).||percentage of participants|||Number
38812|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||percentage of participants|||Number
38813|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).||percentage of participants|||Number
38814|NCT01467661|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||percentage of participants|||Number
38815|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number for participants evaluable at the specific category.||percentage of participants|||Number
38849|NCT01467492|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.|up to Week 72|FA Set.||participants|||Number
38974|NCT01466270|Primary|Retention|Retention is the percentage of participants who stay in the study for 24 weeks.|24 Weeks|All randomized patients||percentage of participants||Standard Error|Mean
38816|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number for participants evaluable at the specific category.||percentage of participants|||Number
38817|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.||percentage of participants|||Number
38818|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.|Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number of participants analysed at specific time point.||percentage of participants|||Number
38819|NCT01467661|Primary|Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
38820|NCT01467661|Primary|Change From Baseline in Platelet Count at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
38821|NCT01467583|Secondary|To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period|Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study|2 years|||participants|||Number
38822|NCT01467583|Primary|To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.|Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay.|2 years|||mcg/ml||Standard Deviation|Mean
38823|NCT01467570|Secondary|ORS Intake at 4 h|% of prescribed ORS that was consumed during first 4 hours|4 hrs|||percentage of prescribed ORS||Standard Deviation|Mean
38824|NCT01467570|Secondary|Adverse Events|any adverse event, providing a description if related or not related to study intervention|24 hours|||participants|||Number
38825|NCT01467570|Secondary|Hospitalization|need for hospitalization within a week|1 week|||participants|||Number
38826|NCT01467570|Secondary|Return Visit to the Emergency Department|Return visit to the emergency department within a week|1 week|||participants|||Number
38827|NCT01467570|Secondary|Duration of Diarrhea (Hrs)|Time of diarrhea in hours|7days|||hrs||Standard Deviation|Mean
38828|NCT01467570|Secondary|Weight Gain in Gram|Weight gain in gram (in the first 24 hours, and total)|24 hours|||gram||Standard Deviation|Mean
38829|NCT01467570|Secondary|ORS Intake in ml|ORS intake in ml (in the first 24 hours, and total)|24 hours|||ml||Standard Deviation|Mean
38830|NCT01467570|Secondary|Vomiting|Vomiting starting or progressing in the first 24 hours of therapy|24 hours|||participants|||Number
38831|NCT01467570|Secondary|Unscheduled Intravenous Therapy|Need for intravenous therapy within 24 hours|24 hours|||participants|||Number
38832|NCT01467570|Primary|Number of Participants That Were Successfully Rehydrated|"The following components are included in primary outcome:~resolution of signs of dehydration~adequate weight gain~production of urine output during the trial"|Proportion of successfully rehydrated at 24 hours|||Participants|||Number
38975|NCT01466192|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
38833|NCT01467557|Secondary|Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys|The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).|Baseline, 2 Week, 4 Month or 12 Month surveys|The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points.||units on a scale||Standard Deviation|Mean
38834|NCT01467557|Primary|Incidence of Adverse Events|Adverse events were reported by subjects via the electronic surveys if they responded “yes” to the question “Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?”. Consensus diagnosis was made after review of clinical records by Adjudication Panel.|Self-report at 2 Week, 4 Month or 12 Month surveys|The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)||participants|||Number
38835|NCT01467505|Other Pre-specified|Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)||4 weeks after last planned dose of study drug (up to Week 52)|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
38836|NCT01467505|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 52|Safety Set included all participants who received at least 1 dose of study drug.||participants|||Number
38837|NCT01467505|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
38838|NCT01467505|Secondary|Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
38839|NCT01467505|Secondary|Percentage of Participants With Biopsy Confirmed and Treated Rejection||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
38840|NCT01467505|Secondary|Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
38841|NCT01467505|Secondary|Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
38842|NCT01467505|Secondary|Percentage of Participants With Viral Relapse||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.|||||
38843|NCT01467505|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.|Baseline up to Week 48|Safety Set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
38844|NCT01467505|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38845|NCT01467505|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38846|NCT01467505|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|Safety Set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
39070|NCT01464931|Secondary|Percent Change From Baseline in Serum C-Telopeptide Over Time||Baseline and Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacodynamic Analysis Set (all participants who received at least 1 dose of denosumab and from whom baseline and at least 1 postbaseline value was collected)||percent change||Inter-Quartile Range|Median
38850|NCT01467492|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety Set.||percentage of participants|||Number
38851|NCT01467492|Secondary|Percentage of Participants With On Treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48|FA Set.||percentage of participants|||Number
38852|NCT01467492|Secondary|Percentage of Participants With Virologic Breakthrough|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, and 12|FA Set.||percentage of participants|||Number
38853|NCT01467492|Secondary|Percentage of Participants With Relapse|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.|4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT|FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA <lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.||percentage of participants|||Number
38854|NCT01467492|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38855|NCT01467492|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last actual dose of study drug (up to Week 72)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38856|NCT01467492|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last actual dose of study drug (up to Week 60)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38857|NCT01467479|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.|Baseline, follow-up (Week 96)|Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.||participants|||Number
38858|NCT01467479|Secondary|Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)|Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.|Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir|Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
38859|NCT01467479|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety set.||percentage of participants|||Number
38860|NCT01467479|Secondary|Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.|EOT (up to Week 48)|Full analysis set included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
39480|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 6 (week 3)||||||
38862|NCT01467479|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38863|NCT01467479|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)|SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|24 weeks after last planned dose of study drug (up to Week 72)|Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.||percentage of participants|||Number
38864|NCT01467479|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.||percentage of participants|||Number
38865|NCT01467076|Secondary|Length of Hospital Stay||Up to one year||||||
38866|NCT01467076|Secondary|Number of Days of Oxygen (O2) Used, and Need for Supplemental Oxygen (O2)||28 Days of LIfe||||||
38867|NCT01467076|Secondary|Duration of Mechanical Ventilation||Until death or hospital discharge, up to on year||||||
38868|NCT01467076|Secondary|Need for Extracorporeal Membrane Oxygenation (ECMO)||Until death or hospital discharge, up to one year||||||
38869|NCT01467076|Secondary|Death||Up to one year||||||
38870|NCT01467076|Secondary|Duration of iNO Therapy||Until death or hospital discharge, up to one year||||||
38871|NCT01467076|Secondary|Need for INO 72 Hours After INO||72 hours after INO||||||
38872|NCT01467076|Secondary|Improvement in Oxygenation Index (OI)||72 Hours||||||
38873|NCT01467076|Secondary|Improvement in Partial Pressure of Oxygen in the Blood (PaO2)||72 hours||||||
38874|NCT01467076|Primary|Assess Feasibility to Recruit at Least 50 Infants|The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (>20%) protocol violations.|9 months after 75% of the participating sites are enrolling|Late preterm & term infants ≤ 7 days postnatal age undergoing conventional ventilation (CNV) or high frequency oscillatory ventilation (HFOV) for NHRF (including perinatal aspiration syndrome, suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic PPHN or suspected pulmonary hypoplasia) with suboptimal response to INO||participants|||Number
38875|NCT01467037|Other Pre-specified|Vaccine Effectiveness of RV1|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.~Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. RV1 VE was estimated as (1 − exposure odds ratio) × 100. Based upon our sampling scheme, the exposure odds ratio from our analyses approximates the rate ratio."|From February 1, 2012 to May 31, 2014|||adjusted VE||95% Confidence Interval|Number
38876|NCT01467037|Primary|Matched VE Participants|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.~We estimated RV1 VE of 2- versus 0-doses and ≥1- versus 0-doseto prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. Children vaccinated with RV5 (private market,minimal penetrance) were excluded."|From February 1, 2012 to May 31, 2014|Rotavirus vaccination history by rotavirus disease status among matched VE participants||participants|||Number
38877|NCT01466881|Other Pre-specified|Aurora Kinase A Expression|To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237|Baseline|Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.||proportion of positivity||Standard Deviation|Mean
38878|NCT01466881|Secondary|To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
38891|NCT01466673|Secondary|Number of Participants With Treatment Response at the End-of-Therapy by Participant’s Self-Assessment at Month 6|Participant’s self-assessment at end-of-therapy was measured by using the self-assessment questionnaire which included 3 questions, about the rating of acne improvement since start of study; comparison of this acne treatment with the one used in past and the continuity of treatment on physician’s prescription to evaluate efficacy and acceptability of the study medication. The score was graded at 4 parameters as excellent, better, no change and worse.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."||Participants|||Number
38879|NCT01466881|Secondary|Progression Free Survival (PFS)|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Patients last known to be alive and without report of progressive disease are censored at date of last contact. Progressive disease is at least 50% increase in the sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions over the smallest sum observed. New bone marrow involvement. New lesion > 1.5 cm in longest axis, or ≥ 50% increase in GTD of any previously involved node with a diameter ≤ 1.0 cm in the short axis such that its longest axis is now > 1.5 cm. Lymph nodes with long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm. PET should be positive if positive PET at baseline.|Up to 2 years after registration|Only eligible patients were included in the analysis||Months||95% Confidence Interval|Mean
38880|NCT01466881|Secondary|Overall Survival (OS)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years after registration|Only eligible patients were included in the analysis.||Months||95% Confidence Interval|Median
38881|NCT01466881|Primary|Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to 1 year after registration|All eligible patients who started treatment were included in assessing response estimates.||participants|||Number
38882|NCT01466790|Secondary|Number of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.|During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
38883|NCT01466790|Secondary|Number of Participants With Inadequate Virologic Response|Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.|Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
38884|NCT01466790|Secondary|Number of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.|Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
38885|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) at Week 48|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.|Week 48|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
38886|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.|Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
38887|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.|Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
38888|NCT01466790|Primary|Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.|Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.||Participants|||Number
38889|NCT01466673|Secondary|Change From Baseline in Body Weight at Month 6|Change from Baseline in body weight is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Kilograms||Standard Deviation|Mean
38890|NCT01466673|Secondary|Change From Baseline in Blood Pressure (BP) at Month 6|Blood pressure is the pressure of blood flowing through blood vessels. Change from Baseline in blood pressure is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Millimeters of Mercury||Standard Deviation|Mean
38892|NCT01466673|Secondary|Percentage of Participants Showing Treatment Response on the Investigator’s Global Assessment at Month 6|Percentage of participants showing treatment response on the Investigator’s global assessment was graded on a 5-point scale as 0=worse, 1=no change, 2=fair, 3=good, and 4=excellent.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."||Percentage of participants|||Number
38893|NCT01466673|Secondary|Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6|Sebum assessment that is facial seborrhea (very oily skin) was assessed using sebutape strip on the forehead. Percentage of participants with facial seborrhea were assessed using categorical scores ranging from level 1 (lowest) to level 5 (highest). Highest level indicates worsening.|Baseline and Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of Participants|||Number
38894|NCT01466673|Secondary|Number of Participants Non-Compliant With Therapy|Compliance was assessed by transforming the data of forgotten tablets listed in the diary cards. Number of participants who forgot to take the drug was reported.|Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Participants|||Number
38895|NCT01466673|Secondary|Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6|Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day.|Month 1, 3 and 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Participants|||Number
38896|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Lesions||Standard Deviation|Mean
38897|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 3|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Lesions||Standard Deviation|Mean
38898|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 1|Intent-to-treat population (ITT) included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||Lesions||Standard Deviation|Mean
38899|NCT01466595|Secondary|Primary Adverse Events|Primary adverse events include all SAEs, defined according to ICH guidelines and targeted protocol events (grade 2 or higher signs and symptoms, grade 2 or higher laboratory abnormality, all diagnoses identified by the ACTG criteria for clinical events, and all events that led to a change in treatment regardless of grade).|from study enrollment until study completion at 12 weeks|||participants|||Number
38900|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 12|Change in total CD4 T-cell count from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||cells/mm3||Inter-Quartile Range|Median
38901|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 12|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 12.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||MFI (relative intensity)||Inter-Quartile Range|Median
38902|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 12|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
38903|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
38904|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
38905|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage CD38+ of CD8+||Inter-Quartile Range|Median
38906|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12||percentage CD38+ of CD4+||Inter-Quartile Range|Median
38907|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 12|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
38908|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 12|Change in soluble CD14 from week 4 to week 12|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 ng/mL||Inter-Quartile Range|Median
38909|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 12|Change in hsCRP from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 ng/mL||Inter-Quartile Range|Median
38910|NCT01466595|Secondary|Change in LPS From Week 4 to Week 12|Change in LPS from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 pg/mL||Inter-Quartile Range|Median
38911|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 12|Change in IL-6 from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 pg/mL||Inter-Quartile Range|Median
38912|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 12|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||log10 ng/mL||Inter-Quartile Range|Median
38913|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 12|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who had data for both week 4 and week 12, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
38914|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 8|Change in total CD4 T-cell count from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||cells/mm3||Inter-Quartile Range|Median
38915|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 8|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 8.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||MFI (relative intensity)||Inter-Quartile Range|Median
38916|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 8|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
38917|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
38918|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
38919|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage CD38+ of CD8+||Inter-Quartile Range|Median
38920|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage CD38+ of CD4+||Inter-Quartile Range|Median
38921|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 8|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
38922|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 8|Change in soluble CD14 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 ng/mL||Inter-Quartile Range|Median
38923|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 8|Change in hsCRP from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 ng/mL||Inter-Quartile Range|Median
38924|NCT01466595|Secondary|Change in LPS From Week 4 to Week 8|Change in LPS from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 pg/mL||Inter-Quartile Range|Median
38925|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 8|Change in IL-6 from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 pg/mL||Inter-Quartile Range|Median
38926|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 8|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8||log10 ng/mL||Inter-Quartile Range|Median
38927|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 8|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who had data for both week 4 and week 8, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8.||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
38928|NCT01466595|Secondary|Change in CD4 Count From Baseline to Week 4|Change in total CD4 T-cell from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||cells/mm3||Inter-Quartile Range|Median
38929|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Baseline to Week 4|"Change in CD38+ of CD8+ MFI (Median Fluorescence Intensity) from baseline to week 4, where baseline value is the average of pre-entry and entry.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||MFI (relative intensity)||Inter-Quartile Range|Median
38930|NCT01466595|Secondary|Change in %HLA-DR+/CD38+ of CD4+ From Baseline to Week 4|Change in CD4 activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
38931|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
39071|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2|Estimated using the linear trapezoidal method.|Days 29 (predose), 36, 43, 57, 71, and 85|PK Parameter Analysis Set||μg*day/mL||Standard Deviation|Mean
38932|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
38933|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage CD38+ of CD8+||Inter-Quartile Range|Median
38934|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage CD38+ of CD4+||Inter-Quartile Range|Median
38935|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cell From Baseline to Week 4|Change in gut-homing percent B7hi+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
38936|NCT01466595|Secondary|Change in sCD14 From Baseline to Week 4|Change in soluble CD14 (sCD14) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 ng/mL||Inter-Quartile Range|Median
38937|NCT01466595|Secondary|Change in hsCRP From Baseline to Week 4|Change in High Sensitivity C-reactive Protein (Hs-CRP) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 ng/mL||Inter-Quartile Range|Median
38938|NCT01466595|Secondary|Change in LPS From Baseline to Week 4|Change in Lipopolysaccharide (LPS) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 pg/mL||Inter-Quartile Range|Median
38939|NCT01466595|Secondary|Change in IL-6 From Baseline to Week 4|Change in Interleukin (IL)-6 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 pg/mL||Inter-Quartile Range|Median
38940|NCT01466595|Secondary|Change in D-dimer From Baseline to Week 4|"Change in D-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry.~D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.||log10 ng/mL||Inter-Quartile Range|Median
38941|NCT01466595|Primary|Change in CD8+ T-cell Activation From Baseline to Week 4|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where the baseline value is the average of pre-entry and entry values.|At baseline and 4 weeks|The primary analysis is as-treated, limited to subjects who had data for both baseline and week 4, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change antiretroviral therapy (ART) or use prohibited medications or have virologic failure during this time period.||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
38942|NCT01466387|Secondary|Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone|In addition to the AEs and SAEs. Additional AESI were collected from day 1 to day 57 postvaccination in subjects after the vaccination of Japanese encephalitis and rabies virus vaccines given concomitantly with MenACWY-CRM197 or alone.|day 1 to day 57 post last vaccination|Analysis was done on the safety data set, i.e. the subjects in the exposed population who provided postvaccination safety data.||subjects|||Number
38943|NCT01466387|Secondary|Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection of anti-rabies virus antibody concentrations 28 days after vaccination of the third dose of rabies virus vaccine, when administered alone or concomitantly either with Japanese encephalitis or with Japanese encephalitis and MenACWY-CRM197 vaccines.~Seroprotection is defined as percentages of subjects who achieved anti-rabies virus antibody concentrations ≥ 0.5 IU/mL on day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
38944|NCT01466387|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197|The immunogenicity was assessed in rabies virus vaccine as measured by geometric mean rabies virus neutralizing antibody concentration, 28 days after vaccination of the third dose, when administered alone or concomitantly either with Japanese encephalitis vaccine or with Japanese Encephalitis and MenACWY-CRM197 vaccines.|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.||IU/mL||95% Confidence Interval|Geometric Mean
38945|NCT01466387|Secondary|Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.~Seroresponse is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post last vaccination (day 29 or day 57)|The analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
38946|NCT01466387|Secondary|Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.|Baseline and 1 month post last vaccination (day 29 or day 57).|The analysis was done on the MITT data set.||titers||95% Confidence Interval|Geometric Mean
38947|NCT01466387|Secondary|Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.~Seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥1:4, seroresponse is defined as a postvaccination hSBA titer of at least four times the baseline."|1 month postvaccination (day 29)|The analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
38948|NCT01466387|Secondary|Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone|Immunogenicity was assessed by Serum Bactericidal Assay using human complement (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the MITT data set.||titers||95% Confidence Interval|Geometric Mean
38949|NCT01466387|Secondary|Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-rabies neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.~Seroprotection is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a post-vaccination hSBA titer of at least 4 times the baseline."|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the MITT data set.||Percentages of subjects||95% Confidence Interval|Number
38950|NCT01466387|Secondary|Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-Japanese encephalitis neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.~Seroprotection is defined as percentages of subjects who achieved anti-JE neutralizing titers ≥ 1/10 on Day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.||Percentages of subects||95% Confidence Interval|Number
38951|NCT01466387|Secondary|Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-YF neutralizing antibody titers after the vaccination of typhoid Vi polysaccharide and yellow fever, given alone or concomitantly with MenACWY-CRM197 on day 29.~Seroprotection is defined as percentages of subjects who achieved anti-YF neutralizing antibody titers ≥ 1/10 on day 29."|Baseline and 1 month postvaccination (day 29).|Analysis was done on the Modified-Intention to Treat (MITT) set, i.e. the subjects who provided evaluable serum samples whose assay results are available for at least one antigen on baseline and on at least one post-baseline visit.||Percentages of subjects||95% Confidence Interval|Number
38952|NCT01466387|Primary|Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||IU/mL||95% Confidence Interval|Geometric Mean
39072|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1|Estimated using the linear trapezoidal method.|Days 1, 8, 15, and 29 (predose)|PK Parameter Analysis Set||μg*day/mL||Standard Deviation|Mean
38953|NCT01466387|Primary|Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the PP set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
38954|NCT01466387|Primary|Geometric Mean Anti-Yellow Fever Antibody Titer|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
38955|NCT01466387|Primary|Geometric Mean Anti-typhoid Vi Antibody Concentrations|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||El.U/mL||95% Confidence Interval|Geometric Mean
38956|NCT01466361|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|"AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.~SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect."|Baseline, 0 minute, 60 minutes and 5 days post treatment|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.||participants|||Number
38957|NCT01466361|Secondary|Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group|Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.|Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm|||percentage|||Number
38958|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 3 minutes and 15 minutes post-treatment|ITT population: All randomized participants who had at least one cravings assessment measurement post dose.||Score on a scale||Standard Error|Least Squares Mean
38959|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 1, 3, 5, 10 and 15 minutes post-treatment|Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data.||Score on a scale||Standard Error|Least Squares Mean
38960|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test|Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with ‘not at all’ and the right hand end with ‘extremely’. For each question, ‘9’ represented the ‘best’ score and ‘1’ represented the ‘worst’ score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Score on a scale||Standard Error|Mean
38961|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Responses||Standard Error|Mean
38962|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Mean
39170|NCT01462942|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24|||Liters||Standard Error|Least Squares Mean
38963|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Error|Mean
38964|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||msec||Standard Error|Mean
38965|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Responses||Standard Error|Mean
38966|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Error|Mean
38967|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Responses||Standard Error|Mean
38968|NCT01466348|Secondary|Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||milliseconds (msec)||Standard Error|Mean
38969|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Deviation|Mean
38970|NCT01466348|Primary|Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 30 minutes post treatment administration|Intent-To-Treat (ITT) population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.||Valid responses||Standard Deviation|Mean
38971|NCT01466270|Secondary|Fatigue|Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.|24 weeks|All randomized participants except two who did not provide any data.||units on a scale||Standard Error|Least Squares Mean
38972|NCT01466270|Secondary|HVLT-IR|Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.|24 weeks|All randomized participants except two who did not provide any data.||number of words recalled||Standard Error|Least Squares Mean
38976|NCT01466179|Secondary|Best Response During the Core Study|"Complete Remission (CR):~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL~Complete Remission With Partial Hematological Recovery (CRh*):~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL~Blast Free Hypoplastic or Aplastic Bone Marrow:~bone marrow blasts ≤ 5%~no evidence of disease~insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL~Partial Remission:~• bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline."|From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.|Primary analysis set||percentage of participants||95% Confidence Interval|Number
38977|NCT01466179|Secondary|Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment|"Blast Free Hypoplastic or Aplastic Bone Marrow was defined as:~bone marrow blasts ≤ 5%~no evidence of disease~insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or absolute neutrophil count (ANC) ≤ 500/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
38978|NCT01466179|Secondary|Serum Cytokine Peak Levels|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.~Serum IL-4 levels were below detection limit (< 20 pg/mL) at all time points in all participants studied."|Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.|Pharmacodynamic Data Set (PDS): All patients who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected. N indicates the number of participants with available data at each time point.||pg/mL||Standard Deviation|Mean
38979|NCT01466179|Secondary|Serum Blinatumomab Concentration at Steady State|The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.|Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.|Pharmacokinetic Data Set (PKS) defined as all patients who received any infusion of blinatumomab and had at least one PK sample collected unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption or sampling information was missing.||pg/mL||Standard Deviation|Mean
38980|NCT01466179|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in remission (CR/CRh*) following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~Patients alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of patients having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods."|From the date of allogeneic HSCT until the data cut-off date of 10 October 2013; median observation time was 7.4 months.|Participants who received an allogeneic HSCT while in remission induced by blinatumomab treatment.||percentage of participants||95% Confidence Interval|Number
38981|NCT01466179|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~An AE was considered “serious” if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.~Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.|Full analysis set (FAS), defined as all patients who received any infusion of blinatumomab.||participants|||Number
38982|NCT01466179|Secondary|Overall Survival|Overall survival was measured for all participants from the time the participant received the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan Meier method.|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set||months||95% Confidence Interval|Median
38983|NCT01466179|Secondary|Event-free Survival|"Event-free survival was calculated from the start date of blinatumomab infusion until the date of bone marrow aspiration at which hematological relapse was first detected, or the date of diagnosis on which the hematological or extramedullary relapse was documented or the date of start of any new therapy for ALL (excluding HSCT), or the date of death, whichever was earlier. Participants who did not achieve complete remission or complete remission with partial hematological recovery during the core study were evaluated as having an event on Day 1. Participants in remission who did not experience hematological relapse, did not receive a new therapy for ALL (excluding HSCT), and did not die were censored on the date of the last available bone marrow aspiration or on the last date of survival follow-up visit, whichever was later.~Event free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set||months||95% Confidence Interval|Median
38984|NCT01466179|Secondary|Relapse-free Survival|"Relapse-free survival was assessed for participants who achieved a complete remission or complete remission with partial hematological recovery during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.~Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.9 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study||months||95% Confidence Interval|Median
38985|NCT01466179|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
38986|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Complete Remission With Partial Hematological Recovery was defined by the following criteria:~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
38987|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"Complete Remission was defined by the following criteria:~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set||percentage of participants||95% Confidence Interval|Number
38988|NCT01466179|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.|Up to the data cut-off date of 10 October 2013. Maximum duration on study was 17.8 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the first 2 cycles of treatment.||percentage of participants||95% Confidence Interval|Number
38989|NCT01466179|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.~Hematological relapse is defined as:~proportion of blasts in bone marrow > 5% after documented CR/CRh* or~blasts in peripheral blood after documented CR/CRh*.~Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.||months||95% Confidence Interval|Median
38990|NCT01466179|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.~Hematological remissions were defined by the following criteria:~Complete Remission (CR):~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL~Complete Remission With Partial Hematological Recovery (CRh*):~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|The Primary Analysis Set (PAS), defined as participants from the first 3 stages of the study who received any infusion of blinatumomab.||percentage of participants||95% Confidence Interval|Number
38991|NCT01466075|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system.|1 hour|Blood data for three subjects were not considered evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.||participants|||Number
38992|NCT01466075|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma).|1 hour|609 venous BG results(203 subjects x 3 test strip lots) were available. Three subjects did not have successful venipunctures so no blood obtained. BGMS testing was not performed with one subject's blood sample. Study staff tested each subject venous blood sample using 3 test strip lots.||percentage of Blood Glucose Test Results|Participants||Number
39020|NCT01465802|Secondary|Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
38993|NCT01466075|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. The remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.||percentage of Blood Glucose Test Results|Participants||Number
38994|NCT01466075|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution Investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.||percentage of Blood Glucose Test Results|Participants||Number
38995|NCT01466062|Secondary|Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121|The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.|Screening, Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.||participants|||Number
38996|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121|Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||mg/dL||Standard Deviation|Mean
38997|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121|Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||U/L||Standard Deviation|Mean
38998|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121|Normal ranges for RBC and platelet count varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||cells *10^4/µL||Standard Deviation|Mean
38999|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121|Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.||cells *10^3/µL||Standard Deviation|Mean
39000|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121|Normal range for hematocrit varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||percentage of red blood cells||Standard Deviation|Mean
39001|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121|Normal range for hemoglobin varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||g/dL||Standard Deviation|Mean
39002|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Weight at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||kilograms||Standard Deviation|Mean
39003|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||beats per minute||Standard Deviation|Mean
39004|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||respirations per minute||Standard Deviation|Mean
39005|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.||degrees Celcius||Standard Deviation|Mean
39006|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n= number of participants with measurements at given time points.||mm Hg||Standard Deviation|Mean
39007|NCT01466062|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants||participants|||Number
39481|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 5 (week 2.5)||||||
39008|NCT01466062|Secondary|Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants who required any of the investigated treatments for RSV. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.|||||
39009|NCT01466062|Secondary|Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection|Number of days of hospitalization caused by RSV infection.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants hospitalized. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.|||||
39010|NCT01466062|Secondary|Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Percentage of participants who required any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants||percentage of participants||95% Confidence Interval|Number
39011|NCT01466062|Secondary|Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection||From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants||percentage of participants||95% Confidence Interval|Number
39012|NCT01466062|Primary|Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121|Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).|Day 1 (Screening), Day 31, Day 121|All participants; n=number of non-missing observations.||µg/mL||Standard Deviation|Mean
39013|NCT01465958|Primary|Mean Trough of Serum Total IgG|Mean trough serum total IgG values were calculated for each subject for the IV Phase (IV #1 and IV #2) and the SC phase (SC Weeks #9 and #12, and End of Treatment/Early termination visit). Mean trough concentration values of serum total IgG during the IV and SC phases were calculated based on the IgG population (subjects who received any amount of study drug and had serum total IgG concentration data).|4 - 5 weeks of IV administration and 12 weeks for SC administration|The IgG Population was used to calculate the trough serum concentrations. The IgG population consisted of all subjects who received any amount of GAMUNEX-C and had any serum total IgG concentration data.||mg/dL||Full Range|Mean
39014|NCT01465958|Primary|Steady-state Area Under the Curve (AUC) for Serum Total Immunoglobulin (IgG)|Steady-state area under the curve (AUC): For the IV phase, the mean adjusted AUC was calculated for all 11 subjects, which included subjects on both 3 and 4 week intravenous (IV) dosing schedules and who had sufficient immunoglobulin G (IgG) data. For the SC phase, the mean AUC was calculated for 10 subjects on weekly subcutaneous (SC) administration and who had sufficient IgG data.|4 to 5 weeks for IV administration; 12 weeks for SC administration|The PK population included the subjects with the availability of sufficient pharmacokinetics (PK) data to calculate area under the curve (AUC) for either the IV or SC phases.||h*mg/dL||Full Range|Mean
39015|NCT01465802|Secondary|Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.~Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
39016|NCT01465802|Secondary|Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.~Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
39017|NCT01465802|Secondary|Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I|CL/F was calculated as dose/AUCtau.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
39018|NCT01465802|Secondary|Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."||hr||Full Range|Median
39019|NCT01465802|Secondary|Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Cmax was obtained from direct inspection of the data.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
39021|NCT01465802|Primary|Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.||hours (hr)||Full Range|Median
39022|NCT01465802|Primary|Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
39023|NCT01465802|Primary|Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|"AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.~ng*hr/mL = nanogram hours per milliliter"|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
39024|NCT01465802|Secondary|Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III|Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).|Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)|As Treated Population||Percentage of Participants|||Number
39025|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II|"PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.~Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Skindex Analysis Population||Score on a scale||Standard Deviation|Mean
39026|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
39027|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
39028|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II|"Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.~Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).~M/T = mouth and throat."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Modified OMDQ Analysis Population; participants meeting primary endpoint analysis & modified OMDQ specific criteria: a) Modified OMDQ completion criteria for initial visit & end of Cycle 2 or EoT visit; b) Completion criteria for at least 5 of 6 visits between initial & end of Cycle 2 visit. n = number of participants completing scale.||Score on a scale||Standard Deviation|Mean
39029|NCT01465802|Primary|Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
39065|NCT01464996|Secondary|Secondary Caries|Percentage of restorations with alfa scores. Absence of caries is evidenced by softness, opacity, or etching at the margin of the restoration.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
39066|NCT01464996|Secondary|Cavosurface Margin Discoloration|Percentage of restorations scoring alfa. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
39030|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I|"Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.~Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|First 8 Weeks of Treatment|PRO Skindex Analysis Population: participants that met primary endpoint analysis & Skindex specific criteria: a) Skindex completion criteria (as above) for initial visit & end of Cycle 2 or EoT visit; b) Skindex completion criteria for at least 5 of 6 visits between initial visit & end of Cycle 2 visit. n = number of participants completing scale.||Score on a scale||Standard Deviation|Mean
39031|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).~95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population||Percentage of Participants||95% Confidence Interval|Number
39032|NCT01465802|Primary|Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.~95% confidence interval (CI) calculated using exact method based on binomial distribution.~After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population - included all participants who received the study treatment assigned at enrollment, but did not discontinue dacomitinib treatment less than 6 weeks from first dosing due to either disease progression or death.||Percentage of Participants||95% Confidence Interval|Number
39033|NCT01465763|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Baseline, Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
39034|NCT01465763|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
39035|NCT01465763|Secondary|Partial Mayo Scores|A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
39036|NCT01465763|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39037|NCT01465763|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39038|NCT01465763|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39039|NCT01465763|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39040|NCT01465763|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39041|NCT01465763|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39042|NCT01465763|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|Full analysis set (FAS) included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39043|NCT01465412|Secondary|Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
39044|NCT01465412|Secondary|AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
39045|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
39046|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
39047|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
39067|NCT01464996|Secondary|Color Match|Percentage of restorations that scored alfa. Restoration matches adjacent tooth structure in color, shade and translucency.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
39068|NCT01464996|Primary|Retention|Overall retention of restorations|6 and 18 months post-baseline|what is reported here is the retention rate using the restoration as the unit of analysis||percentage of restorations|Participants||Number
39048|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
39049|NCT01465412|Primary|Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||ng/mL||Full Range|Least Squares Mean
39050|NCT01465412|Primary|Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.||hr*ng/mL||Full Range|Least Squares Mean
39051|NCT01465230|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|36 months|Participants withdrew from study before primary outcome could be measured|||||
39052|NCT01465178|Secondary|Change in Parameters of the Vitamin D Assay Panel|Secondary outcomes are change in cholecalciferol, 24,25(OH)D3 and free 25(OH)D3.|Baseline, 1 and 4 months post supplementation|Postmenopausal Caucasian women with 25(OH)D < 10 > 30 ng/ml||ng/ml||Standard Deviation|Mean
39053|NCT01465178|Primary|Change in Serum 25-hydroxy Vitamin D3|Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;|Baseline, 1 and 4 months post supplementation|||ng/ml||Standard Deviation|Mean
39054|NCT01465048|Secondary|Dynamics of Plasmodium Falciparum Parasite Growth Following PfSPZ Challenge Administered in Various Regimens|To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge||||||
39055|NCT01465048|Secondary|Frequency, Incidence and Nature of Adverse Events and Serious Adverse Events Arising.|To assess the safety of PfSPZ Challenge administered in various regimens by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements, including lab reports and adverse events.|Participants will be followed for the duration of the study, an expected average of 3 months||||||
39056|NCT01465048|Primary|Number of Participants Infected|To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge|||Participants|||Number
39057|NCT01465022|Secondary|Infant Occipitofrontal Circumference Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."||cm||Standard Deviation|Mean
39058|NCT01465022|Secondary|Infant Weight Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."||kg||Standard Deviation|Mean
39059|NCT01465022|Secondary|Infant Length Growth From 2-8 Weeks|Comparison of infant length at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."||cm||Standard Deviation|Mean
39060|NCT01465022|Secondary|Number of Participants Who Continued Birth Control Method After 6 Months|Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period||participants|||Number
39061|NCT01465022|Primary|Number of Participants Who Continued to Breastfeed at 6 Months|Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period||participants|||Number
39062|NCT01464996|Secondary|Post Operative Sensitivity|Percentage of restorations with alfa scores. No sensitivity.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
39063|NCT01464996|Secondary|Marginal Adaptation and/or Integrity|Percentage of restorations with alfa scores. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
39064|NCT01464996|Secondary|Anatomic Form|Percentage of restorations with alfa scores. Restoration is continuous with existing anatomic form.|18 months post-baseline|||% of restorations with alfa scores|Participants||Number
39069|NCT01464931|Secondary|Number of Participants Who Developed Anti-denosumab Antibodies||From Day 1 (predose) to Day 113|Safety analysis set||participants|||Number
39073|NCT01464931|Secondary|Time to Maximum Observed Serum Denosumab Concentration (Tmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|PK Parameter Analysis Set||days||Full Range|Median
39074|NCT01464931|Secondary|Maximum Observed Serum Denosumab Concentration (Cmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacokinetic (PK) Parameter Analysis Set (all participants who received at least 1 dose of denosumab and for whom PK parameter estimates could be derived)||μg/mL||Standard Deviation|Mean
39075|NCT01464931|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The investigator assessed whether AEs were possibly related to study drug by answering the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?” Abnormal laboratory findings without clinical significance (based on the investigator's judgment) were not recorded as AEs, however, laboratory value changes that required treatment or adjustment in current therapy were considered AEs. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life-threatening (places the participant at immediate risk of death), • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event.|113 days|Safety analysis set||participants|||Number
39076|NCT01464931|Secondary|Percent Change From Baseline in Serum Magnesium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point||percent change||Inter-Quartile Range|Median
39077|NCT01464931|Secondary|Percent Change From Baseline in Serum Phosphorus Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point||percent change||Inter-Quartile Range|Median
39078|NCT01464931|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point||percent change||Inter-Quartile Range|Median
39079|NCT01464931|Secondary|Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria|The severity of hypomagnesemia (a low concentration of magnesium in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (1.5 mg/dL) - 1.2 mg/dL; Grade 2: < 1.2 - 0.9 mg/dL; Grade 3: < 0.9 - 0.7 mg/dL; Grade 4: < 0.7 mg/dL.|113 days|Safety analysis set||participants|||Number
39080|NCT01464931|Secondary|Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria|The severity of hypophosphatemia (a low concentration of phosphates in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (3 mg/dL) - 2.5 mg/dL; Grade 2: < 2.5 - 2.0 mg/dL; Grade 3: < 2.0 - 1.0 mg/dL; Grade 4: < 1.0 mg/dL.|113 days|Safety analysis set||participants|||Number
39081|NCT01464931|Secondary|Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria|The severity of hypocalcemia (a low concentration of calcium, corrected for albumin, in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: albumin-adjusted serum calcium < lower limit of normal (LLN; 9.2 mg/dL) to 8.0 mg/dL; Grade 2: albumin-adjusted serum calcium < 8.0 to 7.0 mg/dL; Grade 3: albumin-adjusted serum calcium < 7.0 to 6.0 mg/dL; Grade 4: albumin-adjusted serum calcium < 6.0 mg/dL.|113 days|Safety analysis set||participants|||Number
39082|NCT01464931|Primary|Number of Participants With Clinically Significant Hypocalcemia|Clinically significant hypocalcemia is defined as albumin-adjusted calcium < 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.|113 days|Safety Analysis Set (all participants who received at least 1 dose of denosumab)||participants|||Number
39083|NCT01464840|Primary|Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration|The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.|48 hours after delivery|||number of participants|||Number
39084|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
39085|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
39086|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
39482|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 4 (week 2)||||||
39087|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.||percentage of participants|||Number
39088|NCT01464827|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin|"The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G)."|Post Treatment Week 24|Intent-to-treat population (all participants who received at least 1 dose of direct-acting antiviral agent); participants with missing data were counted as non-responders.||percentage of participants|||Number
39089|NCT01464827|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:~Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).|Safety population. Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.||participants|||Number
39090|NCT01464619|Secondary|Change in Parenting Discipline|Change from baseline to follow-up of the Parenting Scale (PS), a validated self-report measure of parents' self-reported parenting discipline. Total scores range from 1 to 7 with lower scores indicating better parenting discipline.|3 months|||units on a scale||Standard Deviation|Mean
39091|NCT01464619|Secondary|Change in Social Support|Change from baseline to follow-up of the Multidimensional Scale of Perceived Social Support (MSPSS), a validated self-report measure of perceived social support from family, friends, and a significant other. Total scores range from 12 to 84 with higher scores indicating greater perceived social support.|3 months|||units on a scale||Standard Deviation|Mean
39092|NCT01464619|Secondary|Change in Parenting Stress|Change from baseline to follow-up of the Parenting Stress Index-Short Form Total (PSI-SF), a validated self-report measure of parenting stress. Total scores range from 36 to 180 with higher scores indicating greater levels of parenting stress.|3 months|||units on a scale||Standard Deviation|Mean
39093|NCT01464619|Secondary|Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.|3 months|||participants|||Number
39094|NCT01464619|Secondary|Attendance at 6 or More Incredible Years (IY) Sessions|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of IY.|3 months|||percentage of subjects enrolled|||Number
39095|NCT01464619|Secondary|Acceptability of the Parent Coaching Intervention|"Acceptability of the parent coaching intervention will be assessed by a response to the question How did you like the parenting program? at the conclusion of the parent sessions. the responses ranged from 1 (highly disliked) to 5 (highly liked)"|3 months|No satisfaction measures were collected from the control group, as they received the intervention in a delayed format after their study participation had ended.||units on a scale||Standard Deviation|Mean
39096|NCT01464619|Secondary|Change in Caregiver Depressive Symptoms|Change from baseline to follow-up of the Beck Depression Scale-II (BDI-II), a validated self-report measure of depressive symptoms. The scale range is from 0 to 63 with higher scores indicating worse depressive symptoms.|3 months|||units on a scale||Standard Deviation|Mean
39097|NCT01464619|Primary|Feasibility of a Parent Coaching Intervention|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.|3 months|Original number who enrolled and were assigned to each group.||participants|||Number
39098|NCT01464424|Primary|Overall Mean Intraocular Pressure (IOP)|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.|Week 6|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.||millimeters mercury (mmHg)||Standard Deviation|Mean
39099|NCT01464424|Secondary|Mean IOP at Each After Office Hour Evaluation Timepoint|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.|Week 6: 4 pm, 6 pm, 8 pm|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.||millimeters mercury (mmHg)||Standard Deviation|Mean
39483|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 3 (week 2)||||||
39100|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 2 years from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only untilthe resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|2 Years from Transplantation||||||
39101|NCT01464359|Secondary|Duration of Survival||2 years after Transplantation.||||||
39102|NCT01464359|Secondary|Duration of Survival||1 year after Transplantation.||||||
39103|NCT01464359|Secondary|Duration of Survival||6 months after Transplantation.||||||
39104|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 1 year from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only until the resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|1 Year from Transplantation||||||
39105|NCT01464359|Secondary|Transplant-Related Mortality||Day 180 after Transplantation||||||
39106|NCT01464359|Secondary|Incidence of Acute Graft-Versus-Host Disease||Day 60||||||
39107|NCT01464359|Secondary|Incidence of Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia)|Day 42||||||
39108|NCT01464359|Primary|Disease Free Survival|The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo.|At 3 months|||participants|||Number
39109|NCT01464307|Secondary|Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, ‘n’ specifies those subjects who were evaluated for this outcome measure at given time point.|Baseline, Week 4, 8, and 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.||Units on a scale||Standard Deviation|Mean
39110|NCT01464307|Secondary|Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)|Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4, 8, and 12|"The FAS included subjects in SES of main period for whom primary efficacy variable was available, whereby SES is subset of all subjects who were exposed to IP in main period at least once. Here, “N”(Number of Participants Analyzed) and n signifies those participants who were evaluable for this outcome measure and at given time point respectively."||Percentage of Participants|||Number
39111|NCT01464307|Primary|Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12|A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.|Baseline to Week 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.||Percentage of Participants|||Number
39112|NCT01464307|Primary|Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Baseline and Week 4|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.||Units on a scale||Standard Deviation|Mean
39113|NCT01464255|Primary|Lens Fit – Post-Blink Lens Movement Prior to Removal|The ophthalmologist’s objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
39114|NCT01464255|Primary|Lens Fit – Post-Blink Lens Movement After Insertion|The ophthalmologist’s objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
39115|NCT01464255|Secondary|Overall Lens Pair Preference|Participant’s subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
39484|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 2 (week 1)||||||
39116|NCT01464255|Secondary|Overall Preference – Handling, Removing|Participant’s subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
39117|NCT01464255|Secondary|Overall Preference – Handling, Inserting|Participant’s subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
39118|NCT01464255|Secondary|Overall Preference – Dryness Before Removal|Participant’s subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
39119|NCT01464255|Secondary|Overall Preference – Dryness After Insertion|Participant’s subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
39120|NCT01464255|Secondary|Overall Preference – Comfort Before Removal|Participant’s subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
39121|NCT01464255|Secondary|Overall Preference – Comfort After Insertion|Participant’s subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit|||percentage of participants|||Number
39122|NCT01464255|Primary|Lens Fit – Tightness at One Week|The ophthalmologist’s rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||percentage of tightness||Standard Deviation|Mean
39123|NCT01464255|Primary|Lens Fit – Tightness After Insertion|The ophthalmologist’s rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||percentage of tightness||Standard Deviation|Mean
39124|NCT01464255|Primary|Lens Fit – Decentration at One Week|The ophthalmologist’s objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
39125|NCT01464255|Primary|Lens Fit – Decentration After Insertion|The ophthalmologist’s objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2||mm||Standard Deviation|Mean
39126|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.||pg/mL||Standard Deviation|Mean
39485|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|26 week follow up||||||
39127|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Calcium|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.||mg/dL||Standard Deviation|Mean
39128|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Phosphorus|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.||mg/dL||Standard Deviation|Mean
39129|NCT01464021|Secondary|Percent Change From Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI)|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
39130|NCT01464021|Secondary|Percent Change From Baseline in Physician’s Global Assessment of RA Disease Activity|A horizontal VAS (100 mm) measure of the physician's global assessment of the participant’s current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
39131|NCT01464021|Secondary|Percent Change From Baseline in Patient’s Assessment of Pain|A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
39132|NCT01464021|Secondary|Percent Change From Baseline in Patient’s Global Assessment of Disease Activity|A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
39133|NCT01464021|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
39134|NCT01464021|Secondary|Percent Change From Baseline in C-reactive Protein|C-reactive protein level in serum (mg/dL)|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||percent change||Standard Deviation|Mean
39135|NCT01464021|Secondary|Percent Change From Baseline in Tender and Swollen Joint Counts|Change in number of tender joints and swollen joints for 28 assessed joints.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.||Percent change||Standard Deviation|Mean
39136|NCT01464021|Secondary|Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available||percent change||Standard Deviation|Mean
39137|NCT01464021|Primary|Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1"|Week 12|Participants who received at least 6 consecutive injections of adalimumab (every other week) and have the necessary clinical data for both the Baseline and the Week 12 visit available.||participants|||Number
39138|NCT01463982|Secondary|Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)|"by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100.~Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100.~Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100."|tumor response evaluation can continue to receive the study drug until PD confirmation|||percentage of participants||95% Confidence Interval|Number
39139|NCT01463982|Primary|Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination|If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)|Cycle 1 (21 days)|||percentage of participants||95% Confidence Interval|Number
39140|NCT01463878|Secondary|Quadriceps Muscle Volume|The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.|First versus last measurment in ICU. Up to 14 days (average 7 days)||||||
39141|NCT01463878|Primary|Glycemic Variability|The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.|Entire ICU stay. Up to 14 days in the ICU (average about 7 days)|||mg/dl (MAGE)||Standard Deviation|Mean
39142|NCT01463696|Secondary|AUC at Time of Last Sample (AUClast) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
39143|NCT01463696|Secondary|Area Under the Concentration Time Curve From Hour 0 to Hour 12 (AUC0-12) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 and Day 7, Hour 0 through Hour 12|The APaT population consisted of all participants who received at least one dose of study drug.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
39144|NCT01463696|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours postdose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.||Hours||Full Range|Median
39145|NCT01463696|Secondary|Maximum Observed Plasma Concentration (Cmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8,and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 24 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.||nM||Geometric Coefficient of Variation|Geometric Mean
39146|NCT01463696|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as: any drug-related hematologic toxicity ≥ Grade 3 lasting ≥1 week, ≥ Grade 3 thrombocytopenia with bleeding, ≥ Grade 3 neutropenia with infection OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions/clarifications: 1) Grade 3 nausea, vomiting, diarrhea, and dehydration were excluded from the determination of DLT if, in the opinion of the investigator and sponsor, they occurred in a setting of inadequate treatment, 2) Grade 3 nausea, vomiting, diarrhea, and dehydration were each considered a DLT if they persisted despite 72 hours of maximal supportive care measures or 3) Any abnormal non-hematological laboratory value ≥ Grade 3 (that is not attributable to any other causes) was considered a DLT only if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for ≥1 week.|Cycle 1 (21 days)|The DLT-evaluable population consisted of participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 (dose escalation) or the dose confirmation portion of Part 2, or discontinued due to toxicity.||Participants|||Number
39147|NCT01463683|Primary|Percentage of Participants With Pyrexia Adverse Events|Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis||Percentage of participants|||Number
39148|NCT01463683|Primary|Percentage of Participants With Injection-site Adverse Events|Participants were evaluated for injection-site adverse events using MedDRA version 15.1|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis||Percentage of participants|||Number
39149|NCT01463683|Primary|Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection|Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.|Month 7|The per protocol population consisted of all randomized participants who met enrollment criteria, did not violate the protocol, were seronegative at Baseline, and had vaccination and blood collection. Seroprotection was evaluated only for participants receiving vaccine subcutaneously; intramuscular vaccination was evaluated for safety only.||Percentage of participants|||Number
39150|NCT01463527|Secondary|Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.||Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)||||||
39151|NCT01463527|Primary|Frequency of Staff Interventions for Hypoventilation.|These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.|Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)|||Events per patient minute of sedation||Full Range|Mean
39152|NCT01463384|Primary|Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)|"It has been demonstrated in numerous studies over the past decade that magnetic resonance spectroscopy (MRS) can be used for the diagnosis of Alzheimer’s disease. By measuring an area within the posterior cingulate gyrus, one can obtain a biochemical signature of that region in AD whereby NAA is reduced and mI is increased.~These two biomarkers, N-acetylaspartate (NAA, a neuronal marker) and myo-inositol (mI, a glial marker) were quantified and then used to calculate NAA/mI (an index currently widely used for AD and MCI diagnosis).~Scale of MRS biomarkers for aged-matched controls: NAA = 1.43, mI = 0.60, NAA/mI = 2.38. Any value lower than NAA/mI of 2.38 are considered not normal.~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)|||Ratio||Standard Deviation|Mean
39153|NCT01463384|Primary|Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).|"Using magnetic resonance images acquired, hippocampal volume was measured monthly for 6 months.~Normal range for hippocampal volume in aged-matched controls is 6.6 - 8.8 cm^3.~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)|||cm^3||Standard Deviation|Mean
39154|NCT01463384|Primary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|"RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial skills. RBANS was developed as a stand-alone “core” battery for the detection and neurocognitive characterization of dementia and as a brief neurocognitive battery for the detection and tracking of neurocognitive deficits in a variety of disorders. (Reference: http://rbans.com/)~Qualitative Description of Index Scores:~Index Score Classification 130 and above Very Superior 120-129 Superior 110-119 High Average 90-109 Average 80-89 Low Average 70-79 Borderline 69 and below Extremely Low~Psychometric range for RBANS:~AD 0 - 77 MCI 78 - 99 Normal > 100~Range of scores: Minimum = 0, Maximum = 130~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)|||units on a scale||Standard Deviation|Mean
39155|NCT01463293|Secondary|Adverse Event Frequency|All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.|4 weeks||||||
39156|NCT01463293|Secondary|Overall Product Satisfaction|At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product’s ability to relieve their constipation symptoms on a 5-point ordinal scale|4 weeks||||||
39157|NCT01463293|Secondary|Stool Consistency|Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form|4 weeks||||||
39158|NCT01463293|Secondary|Bowel Movement Frequency|Subjects will record the number of defecations per day in a diary.|4 weeks||||||
39159|NCT01463293|Secondary|Adequate Relief of Constipation (Yes/no)|Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.|4 weeks||||||
39160|NCT01463293|Secondary|Bowel Function Index|The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.|4 weeks||||||
39161|NCT01463293|Secondary|Patient Assessment of Constipation QoL (PAC-QoL)|The PAC-QoL is a 28-question survey that asks questions on their quality of life.|4 weeks||||||
39162|NCT01463293|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM)|The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.|4 weeks||||||
39163|NCT01463293|Primary|Whole Gut Transit Time|The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28|4 weeks|Only 39 out of the 224 enrolled subjects consumed the radio-opaque markers in line with the protocol. Because of the substantial number of protocol deviations and the lack of sufficient evaluable subjects, no further analyses of the study data were performed. The study appears not to have yielded evaluable data.|||||
39164|NCT01463033|Secondary|Adverse Events|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period.|30 day treatment period|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Symptoms reported to be moderate or severe are listed. Adverse events were not monitored for the Observational group.||Events|||Number
39165|NCT01463033|Primary|Post-Traumatic Epilepsy|occurrence of PTE (Post-Traumatic Epilepsy)|2 years|||participants|||Number
39166|NCT01463007|Secondary|Cosmetic Outcome|Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.|2 years|||participants|||Number
39167|NCT01463007|Primary|Early and Intermediate Toxicity|Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.|2 years|||participants|||Number
39168|NCT01462942|Secondary|Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score|SGRQ is a standardised, self-administered tool for measuring impaired health and perceived well-being in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact) Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100: zero (0) score indicating no impairment of quality of life The total SGRQ score ranging from 0 to 100 is a summary score utilising responses to all items calculated using weights attached to each item of the questionnaire Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status|Baseline and Week 24|||Score on a scale||Standard Error|Least Squares Mean
39169|NCT01462942|Secondary|Change in Transition Dyspnoea Index (TDI) Focal Score|Evaluation of dyspnea was performed by an independent interviewer experienced in taking a respiratory history The TDI includes three categories: functional impairment which determines the impact of breathlessness on the ability to perform activities, magnitude of task which determines the type of task that caused breathlessness and magnitude of effort which establishes the level of effort needed to evoke breathlessness Each category ranges from minus three (-3; major deterioration) to plus three (+3; major improvement) including a zero (0) score to indicate 'no change' The three categories are totalled to obtain a focal score (total score) ranging from minus nine (-9), including zero (0), to plus nine (+9) Provision is made for circumstances when dyspnoea could not be rated - if reduction of activities, effort or functional impairment was caused by reasons other than respiratory A change of 1 unit in TDI is used as the criterion for a minimal meaningful improvement|Baseline and Week 24|||Score on a scale||Standard Error|Least Squares Mean
39171|NCT01462942|Primary|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment||Liters||Standard Error|Least Squares Mean
39172|NCT01462929|Secondary|Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value||Liters||Standard Error|Least Squares Mean
39173|NCT01462929|Primary|Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value||Liters||Standard Error|Least Squares Mean
39174|NCT01462877|Secondary|Change in Serum High Sensitivity C-reactive Protein|Blood tests|Baseline and up to 8 weeks after intervention||||||
39175|NCT01462877|Secondary|Change in Serum Creatinine|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of Creatinine change||Full Range|Median
39176|NCT01462877|Secondary|Change in Serum Creatine Kinase|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of CK change||Full Range|Median
39177|NCT01462877|Secondary|Change in Serum Aspartate Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of AST change||Full Range|Median
39178|NCT01462877|Secondary|Change in Serum Alanine Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set||percentage of ALT change||Full Range|Median
39179|NCT01462877|Secondary|Change in Serum Apolipoprotein B|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of apoB change||Standard Deviation|Mean
39180|NCT01462877|Secondary|Change in Serum Apolipoprotein A1|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of apoA1 change||Standard Deviation|Mean
39181|NCT01462877|Secondary|Change in Serum Non-high-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of Non-HDL-C change||Standard Deviation|Mean
39182|NCT01462877|Secondary|Change in Serum High-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of HDL-C change||Standard Deviation|Mean
39183|NCT01462877|Secondary|Change in Serum Low-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set||percentage of LDL-C change||Standard Deviation|Mean
39184|NCT01462877|Secondary|Change in Serum Total Cholesterol|Blood tests|Baseline and up to 8 weeks after intervention|Full analysis set||percentage of TC change||Standard Deviation|Mean
39185|NCT01462877|Primary|Percentage of Triglyceride (TG) Change|Blood tests|Baseline and up to 8 weeks after intervention|Full Analysis Set||percentage of TG change||Standard Deviation|Mean
39186|NCT01462812|Primary|Headache Relief|The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.|120 Minutes|The full analysis dataset (FAD) will include all subjects who are randomized, receive study medication, and record at least one post-treatment assessment of pain severity. The treatment group assignment will be designated according to treatment received. The FAD will serve as the basis for the efficacy analyses.||participants|||Number
39187|NCT01462773|Secondary|Document Any Objective Anti-tumor Responses and Time to Tumor Progression That May Occur in Response to This Treatment Regimen.|"Measure levels of the cell cycle proteins p21 and p27 in PBMCs and tumor biopsies obtained pre-study and during week 4 of Cycle 1 (Day 26).~Conduct histologic evaluations of microvessel density, tumor apoptosis and lymphocytic infiltrates within tumor biopsies obtained pre- and post-study.~Measure plasma levels of bFGF and VEGF over the course of the study.~Monitor the effects of proteasome inhibition on the biological activity of IFN-α within immune cells by measuring Jak-STAT signal transduction in patient PBMCs."|up to 25 weeks|||patients|||Number
39188|NCT01462773|Primary|Determine Dose Limiting Toxicities (DLTs) of VELCADE When Administered in Combination With IFN-α-2b to Patients With Metastatic Malignant Melanoma.|A standard method for the design of this study. Initially, three patients will be treated at a starting dose of VELCADE (1.0 mg/m2). If one of the three patients demonstrates a DLT, then an additional 3 patients will be treated at that dose level. If only one of the six show DLT, then the next cohort of three patients will be entered at the next dose level (1.3 mg/m2). If two or more of the six demonstrate DLT, no further patients will be treated at that dose level. The highest dose level at which less than 2 patients experienced DLT will be expanded to six patients.|up to 25 weeks or until disease progression|||toxicities|||Number
39189|NCT01462695|Primary|Sustained Objective Response Rate|Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks.|Up to 5 years|One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.||percentage of patients||95% Confidence Interval|Number
39198|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose|At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.|24 Hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 24 hours post initial dose of study medication||Participants|||Number
39190|NCT01462435|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours|||units on a scale*hour||Standard Deviation|Mean
39191|NCT01462435|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours|||units on a scale*hour||Standard Deviation|Mean
39192|NCT01462435|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours|||units on a scale*hour||Standard Deviation|Mean
39193|NCT01462435|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight.The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours|||units on a scale*hour||Standard Deviation|Mean
39194|NCT01462435|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours|||mm*hour||Standard Deviation|Mean
39195|NCT01462435|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours|||mm*hour||Standard Deviation|Mean
39196|NCT01462435|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours|||mm*hour||Standard Deviation|Mean
39197|NCT01462435|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48), ANCOVA Model.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent-to-Treat Population||mm*hour||Standard Deviation|Mean
39199|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose|At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.|6 hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 6 hours post initial dose of study medication.||Participants|||Number
39200|NCT01462370|Secondary|PR at Up to 24 Hours Following the Initial Dose|PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation at up to 24 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39201|NCT01462370|Secondary|PID at Up to 24 Hours Following the Initial Dose|PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation up to 24 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39202|NCT01462370|Secondary|PR at Up to 12 Hours Following the Initial Dose|PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation up to 12 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39203|NCT01462370|Secondary|PID at Up to 12 Hours Following the Initial Dose|PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation at up to 12 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39204|NCT01462370|Secondary|Number of Participants Using Rescue Medication 24 Hours After the Initial Dose|Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.|24 Hours|Due to the low number of participants requiring rescue medication use, the time to rescue medication use was not calculated.||Participants|||Number
39205|NCT01462370|Secondary|Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose|"Peak PR during the 6 hours post initial dose is defined as the maximum PR score~recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief."|Up to 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one Peak PR observation up to 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39206|NCT01462370|Secondary|Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose|Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had a PID observation at up to 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39207|NCT01462370|Secondary|Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose|The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.|Baseline and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had an observation at 6 hours post initial dose of study medication, and had a baseline measurement.||Hours||95% Confidence Interval|Mean
39208|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)|The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|24 hours|The population consisted of all participants that received at least one dose of study treatment had a GLOBAL24 observation at 24 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39209|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)|The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|6 hours|The population consisted of all participants that received at least one dose of study treatment and had a GLOBAL6 observation at 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39222|NCT01462357|Secondary|B-cell-mediated Immune Responses in the Sub-cohort for CMI|The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||B-cells/million cells||Inter-Quartile Range|Median
39210|NCT01462370|Secondary|Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)|The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had at least one SPID6 observation up to 6 hours post initial dose of study medication, and had a baseline measurement.||Score on a Scale||Standard Error|Least Squares Mean
39211|NCT01462370|Primary|Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one TOPAR6 observation up to 6 hours post initial dose of study medication.||Score on a Scale||Standard Error|Least Squares Mean
39212|NCT01462357|Secondary|Number of Subjects With Pregnancies|Note: No pregnancies were reported up to the Month 36 time point.|Throughout the study period (From Day 0 up to Month 36)|The Total Vaccinated cohort included all subjects with at least one study vaccine administered.||Subjects|||Number
39213|NCT01462357|Secondary|Number of Subjects Completing the Vaccination Schedule|The number of subjects who have completed the three-dose vaccination schedule in all groups.|Throughout the study period (From Day 0 up to Month 36)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39214|NCT01462357|Secondary|Number of Subjects Starting a Concomitant Medication|The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39215|NCT01462357|Secondary|Number of Subjects Starting a Concomitant Medication|The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.|During the 30-day (Days 0-29) post-vaccination period|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39216|NCT01462357|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39217|NCT01462357|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39218|NCT01462357|Secondary|Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)|Note: Results beyond Month 24 will be updated when validated results become available.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39219|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post-vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39220|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) following vaccination (across doses)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39221|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) following vaccination (across doses)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39223|NCT01462357|Secondary|T-cell-mediated Immune Responses in the Sub-cohort for CMI|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||T-cells/million cells||Inter-Quartile Range|Median
39224|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects|Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.|At Months 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Titers||95% Confidence Interval|Geometric Mean
39225|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Subset of Subjects|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.|At Months 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.||Subjects|||Number
39226|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects|Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Titer||95% Confidence Interval|Geometric Mean
39227|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
39228|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (EL.U/mL) based on ELISA.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||EL.U/mL||95% Confidence Interval|Geometric Mean
39229|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination in the primary study.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
39230|NCT01462357|Primary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|"Anti-HPV 16/18 antibody concentrations were presented as geometric mean titers (GMT) and expressed in IU/mL.~Assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL respectively, after applying the conversion factor from EL.U/mL to IU/mL."|At Month 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||IU/mL||95% Confidence Interval|Geometric Mean
39231|NCT01462357|Primary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA|"Seroconversion was defined as the appearance of antibodies [i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 3.1 and 3.2 international units per milliliter (IU/mL), respectively], in the serum of subjects who were seronegative before vaccination in the primary study.~The assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL, after applying the conversion factor from EL.U/mL to IU/mL."|At Month 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
39232|NCT01462357|Primary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (EL.U/mL) based on ELISA.|One month after the last dose of study vaccine (Month 7)|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||EL.U/mL||95% Confidence Interval|Geometric Mean
39233|NCT01462357|Primary|Number of Seroconverted Subjects for Anti-HPV-16/18, as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 19 and 18 EL.U/mL, respectively), in the serum of subjects seronegative before vaccination in the primary study.|One month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.||Subjects|||Number
39234|NCT01462344|Secondary|Percentage of Asthma Control Days Over the 6-month Study Treatment Period|An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population||Percentage of asthma control days||Standard Error|Mean
39235|NCT01462344|Secondary|Percentage of Rescue-free Days Over the 6-month Study Treatment Period|Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population||Percentage of rescue-free days||Standard Error|Mean
39486|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|12 week follow up||||||
39236|NCT01462344|Secondary|Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period|An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.|From Day 1 up to 6 months|mITT Population||Participants|||Number
39237|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period|Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population||Participants|||Number
39238|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period|Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population||Participants|||Number
39239|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.|Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population||Participants|||Number
39240|NCT01462344|Primary|Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period|Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.|From Day 1 up to 6 months|mITT Population||Participants|||Number
39241|NCT01462344|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a >=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.|From Day 1 up to 6 months|ITT Population||Participants|||Number
39242|NCT01462279|Secondary|Improvement in Hemodynamics|Measurements are taken at baseline and are continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.|Baseline to Nine Hours||||||
39243|NCT01462279|Primary|Improvement in VO2|VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.|Baseline to 9 Hours|||ml/min||Standard Deviation|Mean
39244|NCT01462266|Secondary|Time to Achieve the Fasting Glucose Target|Fasting glucose target 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). This analysis was the Kaplan-Meier estimated 50th percentile of time (days) to first attainment of target.|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication and had at least one post-randomization glycemic goal assessment.||Days to first attainment of target||95% Confidence Interval|Median
39245|NCT01462266|Secondary|Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study|The fasting glucose target was defined as 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L).|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication, and had at least one post-randomization glycemic goal assessment.||Percentage of participants||95% Confidence Interval|Number
39246|NCT01462266|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change in FPG (before breakfast) following 24 weeks of therapy (i.e., FPG at Week 24 minus FPG at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.||mg/dL||95% Confidence Interval|Least Squares Mean
39247|NCT01462266|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
39248|NCT01462266|Primary|Change From Baseline in Daily Insulin Dose at Week 24|Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)|Baseline and Week 24|Full Analysis Set (FAS) population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.||International Units (IU)||95% Confidence Interval|Least Squares Mean
39249|NCT01462227|Secondary|Norepinephrine (pg/mL)|Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||pg/mL||Standard Deviation|Mean
39250|NCT01462227|Secondary|Epinephrine (pg/mL)|Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||pg/mL||Standard Deviation|Mean
39253|NCT01462227|Primary|Glucose Infusion Rate (mg/kg.Min)|The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||mg/kg.min||Standard Deviation|Mean
39254|NCT01462227|Primary|Glucose (mg/dL)|Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.||mg/dL||Standard Deviation|Mean
39255|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||percentage of participants|||Number
39256|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||percentage of participants|||Number
39257|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population|DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure.||score on a scale||Standard Deviation|Mean
39258|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24|DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis: All participants who had at least one measurement of effectiveness subsequent to the start of tocilizumab (RoActemra) treatment were included. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||score on a scale||Standard Deviation|Mean
39259|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||score on a scale||Standard Deviation|Mean
39260|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||score on a scale||Standard Deviation|Mean
39307|NCT01461811|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
39487|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|5 weeks (or after treatment session 10)||||||
39261|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||score on a scale||Standard Deviation|Mean
39262|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.||score on a scale||Standard Deviation|Mean
39263|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||centimeter||Standard Deviation|Mean
39264|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24|Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||centimeter||Standard Deviation|Mean
39265|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||hours||Standard Deviation|Mean
39266|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||hours||Standard Deviation|Mean
39267|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||swollen joints||Standard Deviation|Mean
39268|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, Week 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.||swollen joints||Standard Deviation|Mean
39269|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population|Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.||unstandardized regression coefficient|||Number
39270|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. Here, N=number of participants analyzed for this measure.||unstandardized regression coefficient|||Number
39271|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. N=number of participants analyzed for this measure.||unstandardized regression coefficient|||Number
39272|NCT01462162|Secondary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. Here, N=number of participants analyzed for this measure.||unstandardized regression coefficient|||Number
39273|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Serum Hemoglobin|The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants for each category.||g/L||Standard Deviation|Mean
39274|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, Week 24|Effectiveness analysis population.||units on a scale||Standard Deviation|Mean
39275|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 24|Effectiveness analysis population. Here, N=number of participants evaluable for this measure.||unstandardized regression coefficient|||Number
39276|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12|Effectiveness analysis population included all participants who had all measurements of effectiveness and had complete information of the FACIT questionnaire throughout the study. Here, Number of participants analyzed (N) = number of participants evaluable for this measure.||unstandardized regression coefficient|||Number
39277|NCT01462045|Secondary|Cortisol|Change from baseline in serum cortisol levels at 8 weeks. Serum cortisol samples were collected at 8:00 Ante Meridian (AM). The changes are calculated from two time points as the values at 8 weeks minus the values at baseline.|baseline and 8 weeks|||μg/dl||Standard Deviation|Mean
39294|NCT01461980|Secondary|Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens|Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.||percentage of participants||95% Confidence Interval|Number
39278|NCT01462045|Primary|Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score|The PCL-C is a 17-item self-report instrument that measures the symptoms of PTSD. A total score, ranging from 17 to 85, is found by summing the scores of the 17 items. Higher values are considered to be a worse outcome. The inclusion criteria in the PTSD symptomatic group is a PCL-C total score of at least 28 with a score of 3 or higher on 1 or more items.To detect a reduction in PTSD symptom severity with a 2-sided 5% significance level and a power of 80%, the mean difference of PCL-C scores of 5.16 or greater requires a sample size of 20 participants for Exercise and Control groups, given an anticipated dropout rate of 10%. Data analyses are conducted using an a priori intention-to-treat approach. The analysis for the between-group differences of the intervention is conducted using t-tests comparing Exercise and Control groups at post-intervention. The analysis for the within-group difference is conducted using repeated measures ANOVA for both groups at baseline and week 8.|Baseline and 8 weeks|For Base Group, the values entered represent the mean value of the baseline PCL-C scores. The mean difference score for the Base Group is not available because the Base Group was assessed only at baseline.||scores on a scale||Standard Deviation|Mean
39279|NCT01461993|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|||percentage of participants|||Number
39280|NCT01461993|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)||Before Vaccination 1, 1 month after Vaccination 2, 3|||titer||95% Confidence Interval|Geometric Mean
39281|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Vaccination 1, 1 month after Vaccination 2, 3|||percentage of participants|||Number
39282|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||Before vaccination 1, 1 month after vaccination (Vac) 2, 3|||percentage of participants|||Number
39283|NCT01461993|Secondary|Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants||Before vaccination 1|||percentage of participants|||Number
39284|NCT01461993|Secondary|Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)||1 month after Vaccination 3|||percentage of participants|||Number
39285|NCT01461993|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]||1 month after Vaccination 3|||titer||95% Confidence Interval|Geometric Mean
39286|NCT01461993|Primary|Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens||1 month after Vaccination 3|||titer||95% Confidence Interval|Geometric Mean
39287|NCT01461980|Other Pre-specified|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.||percentage of participants|||Number
39288|NCT01461980|Other Pre-specified|Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.||percentage of participants||95% Confidence Interval|Number
39289|NCT01461980|Other Pre-specified|Immunogloblulin G (IgG) Measured by GMC|IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.|Before Vaccination 1, 1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
39290|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.||percentage of participants||95% Confidence Interval|Number
39291|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.||percentage of participants||95% Confidence Interval|Number
39292|NCT01461980|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.||titer||95% Confidence Interval|Geometric Mean
39293|NCT01461980|Secondary|Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens|Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen.||percentage of participants||95% Confidence Interval|Number
39295|NCT01461980|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3|Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|1 Month after Vaccination 3|Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
39296|NCT01461980|Primary|Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens|Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘N’ signifies participants with valid and determinate assay results for given strain for each group, respectively.||titer||95% Confidence Interval|Geometric Mean
39297|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens|Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid and determinate assay results for given antigen.||EU/mL||95% Confidence Interval|Geometric Mean
39298|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens|Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, ‘number of participants analyzed’ signifies participants with valid and determinate assay results for given antigen.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
39299|NCT01461811|Secondary|Back Surface Debris/Deposits (None, Very Slight)|"Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
39300|NCT01461811|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
39301|NCT01461811|Secondary|Front Surface Wettability (None, Very Slight)|"Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
39302|NCT01461811|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
39303|NCT01461811|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of lenses|||Number
39304|NCT01461811|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
39305|NCT01461811|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
39306|NCT01461811|Secondary|Subjective Rating of End of Day Dryness|End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
39488|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|2.5 weeks (or after treatment session 5)||||||
39308|NCT01461811|Secondary|Subjective Rating of End of Day Comfort|End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
39309|NCT01461811|Secondary|Subjective Rating of Insertion Comfort|Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Units on a scale||Standard Deviation|Mean
39310|NCT01461811|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.||Percentage of eyes|||Number
39311|NCT01461733|Primary|Conversion From Atrial Fibrillation to Sinus Rhythm|Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.|From randomization to conversion or ICU discharge up to 100 months.|||participants|||Number
39312|NCT01461655|Secondary|Investigator Global Assessment (IGA) of Disease Severity|"The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).~The outcome was the proportion of success (improvement of two grades of the IGA) from baseline to the end of treatment. “Success” is defined as improvement of two grades from the baseline assessment."|Baseline to End of treatment (4 weeks)|||participants|||Number
39313|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 22|Baseline to Day 22|||percentage of change||Standard Deviation|Mean
39314|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 15|Baseline to Day 15|||percentage of change||Standard Deviation|Mean
39315|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total leasions count from baseline to day 8|Baseline to Day 8|||percentage of change||Standard Deviation|Mean
39316|NCT01461655|Secondary|Total Lesions Count|Percentage change in total lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)|||percentage of change||Standard Deviation|Mean
39317|NCT01461655|Secondary|Non-inflammatory Lesions Count|Percentage change in non-inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)|||percentage of change||Standard Deviation|Mean
39318|NCT01461655|Primary|Percentage Change in Inflammatory Lesions From Baseline to End of Treatment|Percentage change in inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)|||percentage of change||Standard Deviation|Median
39319|NCT01461551|Secondary|Intensive Care Unit Staying Days||participants will stay in intensive care unit after surgery, an expected average of 2 days||||||
39320|NCT01461551|Primary|Lymphocyte Count|Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.|1 day after surgery|||cells/nanoliter||Standard Deviation|Mean
39321|NCT01461538|Secondary|Incidence of Anti-therapeutic Antibodies (ATA)|Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.|Up to approximately 3 years|Immunogenicity-evaluable set||participants|||Number
39322|NCT01461538|Secondary|Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available MMAE Ctrough results||ng/mL||Geometric Coefficient of Variation|Geometric Mean
39323|NCT01461538|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)||Up to approximately 3 years|All treated patients with available Cmax of MMAE results||ng/mL||Geometric Coefficient of Variation|Geometric Mean
39324|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available ADC Ctrough results||ug/mL||Geometric Coefficient of Variation|Geometric Mean
39325|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)||Up to approximately 3 years|All treated patients with available ADC Ceoi results||ug/mL||Geometric Coefficient of Variation|Geometric Mean
39326|NCT01461538|Secondary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category|Up to approximately 3 years|All treated patients||participants|||Number
39327|NCT01461538|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to approximately 3 years|All treated patients||participants|||Number
39328|NCT01461538|Secondary|Progression-Free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 2 years|All treated patients, excluding 3 patients without available response results||months||95% Confidence Interval|Median
39329|NCT01461538|Secondary|Duration of Complete Response by Kaplan-Meier Analysis|Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with CR||months||Full Range|Median
39330|NCT01461538|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with objective response (CR [+CRi; leukemia] + PR)||months||Full Range|Median
39331|NCT01461538|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population||percentage of participants||95% Confidence Interval|Number
39332|NCT01461538|Primary|Objective Response Rate (ORR) by Investigator|Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population||percentage of participants||95% Confidence Interval|Number
39333|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Pain Imaginable.~The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.||mm||Standard Error|Least Squares Mean
39334|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.||mm||Standard Error|Least Squares Mean
39335|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
39336|NCT01461369|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
39337|NCT01461369|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
39360|NCT01461044|Secondary|Percentage of Participants With Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.||percentage of participants|||Number
39338|NCT01461369|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.||mm||Standard Error|Least Squares Mean
39339|NCT01461096|Secondary|Time to First New Persistent Oral HPV Infection of Vaccine Types Detected From Oral Rinse|"The outcome for this evaluation was time to the first new persistent infection of any of oral HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive oral HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary endpoint if they were PCR negative for at least one of the four vaccine HPV types at baseline.~NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study|mITT population wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.||Years||95.1% Confidence Interval|Number
39340|NCT01461096|Secondary|Number of Participants With Grade 3 or 4 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine, as Determined by the Local Investigator|To grade diagnoses, signs and symptoms, and laboratory results, sites must refer to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, august 2009).|From baseline to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study|mITT population including all participants who received at least one dose of vaccine.||Participants|||Count of Participants
39341|NCT01461096|Secondary|Number of Participants With Anal Cytological Abnormality Occurrences|Anal cytologic abnormalities include: atypical squamous cells undetermined significance (ASCUS), atypical squamous cells favor high-grade SIL/squamous cell carcinoma (ASC-H), low-grade squamous intraepithelial lesion/mild dysplasia/HPV (LSIL), or high-grade SIL/moderate dysplasia to severe dysplasia/carcinoma in situ/features of invasion (HSIL).|At baseline, Week 52, Week 104 and Week 156|mITT population including all participants who received at least one dose of vaccine.||Participants|||Count of Participants
39342|NCT01461096|Secondary|Number of Participants With Biopsy-proven High-grade Anal Intraepithelial Neoplasia (HGAIN) Occurrences and Reoccurrences After Week 52|HGAIN was defined as AIN2 (moderate dysplasia, with no mention of AIN grade III), AIN3 (severe dysplasia, carcinoma in-situ, or AIN grade II/III), high grade AIN not specified, or adenocarcinoma in situ found in the intra-anal or perianal region.|From Week 52 to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study|mITT population including all participants who received at least one dose of vaccine.||Participants|||Count of Participants
39343|NCT01461096|Primary|Time to the First New Persistent Infection of HPV 6, 11, 16, or 18|"The outcome for this evaluation was time to the first new persistent infection of any of HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive anal HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary outcome if they were PCR negative for at least one of the four vaccine HPV types at baseline.~NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, which occurred 3 to 4 years after the last participant was enrolled in the study|The efficacy analysis for persistent anal HPV employed a modified intent-to-treat (mITT) approach wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.||Years||95.1% Confidence Interval|Number
39344|NCT01461057|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|Randomization of first participant to clinical cutoff date (01 March 2015) (approximately 41 months)|Safety population included all participants who received at least one dose of study treatment.||participants|||Number
39345|NCT01461057|Primary|Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)||Day 43|The primary pharmacokinetic (PK) analysis population consisted of all participants with a measurable PK samples on Day 43.||percentage of participants||95% Confidence Interval|Number
39346|NCT01461044|Secondary|Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||percentage of participants|||Number
39347|NCT01461044|Secondary|Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were available for this evaluation.||percentage of participants|||Number
39361|NCT01461044|Secondary|Percentage of Participants With Reasons for Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.||percentage of participants|||Number
39489|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|26 Week follow up||||||
39348|NCT01461044|Primary|Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39349|NCT01461044|Primary|Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39350|NCT01461044|Primary|Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression|The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with < or >=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39351|NCT01461044|Primary|Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression|MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39352|NCT01461044|Primary|Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39353|NCT01461044|Primary|Percentage of Participants With HR Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39354|NCT01461044|Primary|Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39355|NCT01461044|Primary|Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39356|NCT01461044|Primary|Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants|||Number
39357|NCT01461044|Primary|Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.||percentage of participants||95% Confidence Interval|Number
39358|NCT01461044|Primary|Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression|Percentage of participants that reported metastatic disease in less than or equal to (<=) 3 sites or greater than (>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of metastatic sites.||percentage of participants||95% Confidence Interval|Number
39359|NCT01461044|Secondary|Percentage of Participants With Reasons for Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were definitive discontinued.||percentage of participants|||Number
39362|NCT01461044|Secondary|Percentage of Participants With Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.||percentage of participants|||Number
39363|NCT01461044|Secondary|Duration of Bevacizumab as First Line Treatment||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||months||Full Range|Median
39364|NCT01461044|Primary|Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression|Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.||percentage of participants||95% Confidence Interval|Number
39365|NCT01461044|Primary|Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BRCA mutation.||percentage of participants|||Number
39366|NCT01461044|Primary|Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BMI which was measured in kg/m^2.||kg/m^2||Standard Deviation|Mean
39367|NCT01461044|Primary|Mean Height at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of height.||centimeters||Standard Deviation|Mean
39368|NCT01461044|Primary|Mean Body Weight at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of body weight.||kilograms||Standard Deviation|Mean
39369|NCT01461044|Primary|Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of ECOG PS.||percentage of participants|||Number
39370|NCT01461044|Primary|Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression|Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of menopausal status.||percentage of participants|||Number
39371|NCT01461044|Primary|Mean Age at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.||years||Standard Deviation|Mean
39372|NCT01461044|Primary|Disease-Free Interval|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.||months||Full Range|Median
39373|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.||percentage of participants||95% Confidence Interval|Number
39374|NCT01461044|Secondary|Overall Survival (OS)|OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||months||95% Confidence Interval|Median
39375|NCT01461044|Secondary|Percentage of Participants With Death|Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.||percentage of participants|||Number
39376|NCT01461044|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.||months||95% Confidence Interval|Median
39377|NCT01461044|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.||months||95% Confidence Interval|Median
39378|NCT01461044|Secondary|Percentage of Participants With Disease Progression or Death|"Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment."|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population.||percentage of participants|||Number
39379|NCT01461044|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.||percentage of participants||95% Confidence Interval|Number
39380|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.||percentage of participants||95% Confidence Interval|Number
39381|NCT01460927|Primary|Fitzpatrick Classification of Wrinkling and Degree of Elastosis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri orbital wrinkles.~Observing changes to the surface by visual and photographic analysis based on the score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis. (Lasers Surg Med 2003;33(4):232 42)~Score Wrinkling & Degree of Elastosis 1-3 Fine wrinkles (rhytides) and Mild Elastosis (fine textural changes with subtly accentuated skin lines) 4-6 Fine to moderate depth wrinkles, moderate number of lines and Moderate Elastosis (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia)"|Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU|Per protocol||Fitzpatrick Classification Scale||Full Range|Mean
39382|NCT01460732|Secondary|Dippers Defined by ABPM and HBPM-Nocturnal|As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.|2 weeks|All patients who had their Daytime and Nocturnal BP assessed by both methods.||percentage of patients|||Number
39383|NCT01460732|Primary|Asleep Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks|||mmHg||Standard Deviation|Mean
39384|NCT01460732|Primary|Asleep Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks|||mmHg||Standard Deviation|Mean
39385|NCT01460732|Primary|Awake Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks|||mmHg||Standard Deviation|Mean
39391|NCT01460446|Secondary|The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score|"The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) contains 6 items which can be scored from 0=‘very bad’ to 6=‘very good’. The total score is the sum of the scores of the 6 items and ranges from 0 to 36. A higher score indicates more satisfaction. This questionnaire was administered at Baseline only.~The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3=‘much worse now’ to 3=‘much better now’). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only."|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Units on a scale||Standard Deviation|Mean
39392|NCT01460446|Secondary|Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24|The Hypoglycemia Fear Survey-II (HFS-II) contains 33 items (15 items regarding behavior and 18 items regarding worry) which can be rated from 0=‘never’ to 4=‘always’). The total HFS-II score ranges from 0 to 132 with a higher score indicating more fear. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.||Units on a scale||Standard Deviation|Mean
39393|NCT01460446|Secondary|Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24|The Problem Area in Diabetes (PAID) scale contains 20 items which can be rated from 0=‘not a problem’ to 4=‘serious problem’. The total PAID scale score ranges from 0 to 80 with a higher score indicating more diabetes-related problems. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.||Units on a scale||Standard Deviation|Mean
39394|NCT01460446|Secondary|Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24|The Major Depression Disorder (MDD) scale is derived from the Patient Health Questionnaire depression scale (PHQ-8) and was used to categorize participants in regard to the severity of their depression. There are 5 categories on the MDD scale: None, mild, moderate, moderately severe, and severe. The category for each participant is determined from their PHQ-8 score. A total PHQ-8 score of 0 to 4 represents no significant depressive symptoms. A total PHQ-8 score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. A higher score indicates more depression.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Participants|||Number
39395|NCT01460446|Secondary|Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24|The Patient Health Questionnaire depression scale (PHQ-8) contains 8 items which can be rated from 0='not at all' to 3='nearly every day'. The total PHQ-8 score is the sum of the responses to the 8 items and ranges from 0 to 24. A lower score indicates less depression. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who had data available for analysis.||Units on a scale||Standard Deviation|Mean
39396|NCT01460446|Secondary|Change in Carbohydrate Counting Accuracy From Baseline to Week 24|Participants were asked to assess the carbohydrate content (grams) of 10 standardized meals by using a set of Dose Adjustment for Normal Eating (DAFNE) plates, which provide standardized photographs of meals with known carbohydrate values. The mean meal error (MME), an indicator of accuracy, and mean meal absolute error (MMAE), an indicator of variability were calculated from their responses. The MME is defined as the mean of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. A negative MME indicates an underestimation and a positive MME indicates an overestimation of the actual carbohydrate content. The MMAE is defined as the mean of the absolute value of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. The MMAE is ≥ 0 with a lower value indicating a better ability to estimate the actual carbohydrate content.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.||Grams||Standard Deviation|Mean
39397|NCT01460446|Secondary|Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study|Participants using the Aviva Nano blood glucose meter received individualized advice in how to use their insulin:carbohydrate ratio (I:CHO) and insulin sensitivity factor (ISF) values to determine their insulin dose. The I:CHO ratio advice was considered to have been used correctly if the meal bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant’s total carbohydrate intake and the I:CHO ratio. The ISF advice was considered to have been correctly used if the correction bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant’s blood glucose target, current blood glucose value, and the ISF.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study. Results are only reported for participants using the Aviva Nano blood glucose meter who had data available for analysis.||Number of advices per day||Standard Deviation|Mean
39398|NCT01460446|Secondary|Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.||Number of advices modified per day||Standard Deviation|Mean
39399|NCT01460446|Secondary|Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.||Percentage of opportunities||Standard Deviation|Mean
39441|NCT01459783|Secondary|Change in Caregiver Depression at 6 and 12 Months|"The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks. The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders. It covers each of the 9 DSM-IV depression criteria scoring them as 0 (not at all) to 3 (nearly every day)."|0, 6 and 12 months||||||
39400|NCT01460446|Secondary|Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24|Approximately half of the investigational sites monitored glucose levels in participants enrolled in this study using the DexCom Seven® Plus Continuous Glucose Monitoring device. The device provides glucose measurements every 5 minutes for up to 7 days. The system contains a sensor, transmitter, and receiver. The sensor is a flexible round wire that goes under the skin to read glucose levels. The transmitter snaps into the sensor and wirelessly sends glucose readings to the receiver. Data was obtained from approximately one-third of participants and was used to calculate MAGE. Data were collected in the 3 days prior to Baseline and the Week 24 visit. The standard deviation of the blood glucose measurements in each 3-day period was calculated. For each glucose measurement, the difference from the previous reading was calculated. Absolute differences smaller than the standard deviation were discarded. MAGE is the mean of the remaining difference scores.|3 days prior to Baseline to Week 24|Intent-to-treat population: All randomized participants with continuous glucose monitoring data at Baseline and at Week 24 who completed the study.||mg/dL||Standard Deviation|Mean
39401|NCT01460446|Secondary|Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24|A symptomatic hypoglycemic episode was defined as an event with symptoms consistent with hypoglycemia which was confirmed by a blood glucose reading < 70 mg/dL (3.9 mmol/L). Symptoms might include but were not limited to sweating, dizziness, lightheadedness, tremors, nervousness, hunger, headaches, and weakness or tiredness.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Episodes per year||Standard Deviation|Mean
39402|NCT01460446|Secondary|Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24|Participants measured their blood glucose at least 3-4 times daily throughout the study. The mean blood glucose level was calculated for each 3-day period from Baseline to Week 24 and the percentage of 3-day blood glucose levels with the target range of 70-180 mg/dL (3.9-10 mmol/L) was calculated for the 2 reporting periods of Screening to Baseline and Week 23 to Week 24.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Percentage of measurements||Standard Deviation|Mean
39403|NCT01460446|Primary|Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24|HbA1C was measured in blood samples at a central laboratory.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.||Percentage||Standard Deviation|Mean
39404|NCT01460342|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) Score at 2 Weeks|The mIPSS Total Score was the sum of Questions 1 through 7 in the mIPSS questionnaire, which was a modified version of the IPSS questionnaire. Questions about the participant's urination experiences and prostate symptoms in the IPSS questionnaire were modified to obtain responses based on time since the last visit rather than during the last month. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an mIPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the analysis of covariance (ANCOVA) model with treatment, prior alpha-blocker use (yes/no), and country (Japan/Korea) as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
39405|NCT01460342|Secondary|Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks|The CGI-I measured the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.||participants|||Number
39406|NCT01460342|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks|The PGI-I scale measured the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.||participants|||Number
39407|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|"The IPSS QoL Index assessed the participant's response to the following question, If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options were 0 (Delighted), 1 (Pleased), 2 (Mostly satisfied), 3 (Mixed, about equally satisfied and dissatisfied), 4 (Mostly dissatisfied), 5 (Unhappy), and 6 (Terrible), for a QoL Index Score that ranged from 0 to 6. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates."|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
39408|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|The IPSS Voiding (Obstructive) Subscore was the sum of Questions 1, 3, 5, and 6 in the IPSS questionnaire. Each question was scored from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms) for an IPSS Voiding (Obstructive) Subscore that ranged from 0 to 20; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
39417|NCT01460290|Secondary|World Health Organization Disability Assessment Scale (WHO-DAS)|The WHO-DAS II is used to assess patients for difficulties that they experience due to health conditions. Six subscales are represented which cover the following domains: Getting Around (range 1-10), Self Care (range 1-10), Life Activities (range 1-20), Understand/Communicate (range 1-10), Participation in Society (range 1-10), and Getting Along with People (range 1-10). Lower scores represent more positive outcomes, while higher scores represent worse outcomes. Total summary scores were not computed for our analyses and is optional for the measure.|12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
39409|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|The IPSS Storage (Irritative) Subscore was the sum of Questions 2, 4, and 7 in the IPSS questionnaire. Each question was scored from 0 (no irritative symptoms) to 5 (frequent irritative symptoms) for an IPSS Storage (Irritative) Subscore that ranged from 0 to 15; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
39410|NCT01460342|Secondary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS)|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
39411|NCT01460342|Primary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.||units on a scale||Standard Error|Least Squares Mean
39412|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Recognition Discrimination Index appears in this entry below"|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||number of items||Standard Deviation|Mean
39413|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Retention scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||percentage of items||Standard Deviation|Mean
39414|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Delayed recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||correctly recalled items||Standard Deviation|Mean
39415|NCT01460290|Secondary|Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS)|The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. The highest possible total score is 40. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
39416|NCT01460290|Secondary|Barnes Drug-induced Akathisia Rating Scale (BARS)|This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
39490|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|12 Week follow up||||||
39418|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS)|The DRS contains items that evaluate cognitive function across 5 subscales: attention, initiation/perseveration, construction, conceptualization, and memory. Subscale raw score ranges are: attention (0-37), initiation/perseveration (0-37), construction (0-6), conceptualization (0-39), and memory (0-25). Raw subscale scores are added for a total raw score with range 0-144. For each raw subscale score, scaled scores are looked up from a battery of 13 tables. Age of the participant determines which table is to be used. Total raw subscale score also has its own scaled score in the tables. In addition to use in determining scaled scores for each of the subscales, these tables are used to look up the scaled score for the total raw score. The tables are contained in the article Robust and Expanded Norms for the Dementia Rating Scale (Pedraza, Lucas, et al. 2010); Archives of Clinical Neuropsychology 25; 347-358. Higher scores, raw and scaled, indicate better cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||units on a scale||Standard Deviation|Mean
39419|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-36). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Total recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||correctly recalled items||Standard Deviation|Mean
39420|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Trail Making Test|The Trails test is a measure of cognitive functioning. The measure consists of two parts: A and B. In part A, participants are asked to draw a trail connecting a series of numbers in sequential order. In Part B, participants are asked to draw a trail connecting a combination of letters and numbers. The time taken to complete each task is noted as the score (e.g., 78 seconds). For Trails A, there is no upper limit on the score, as subjects are given as much time as is needed for them to complete the task. Higher scores indicate poorer cognitive functioning. In Trails B, the task is timed with an upper limit of five minutes. If, at four minutes, it is determined that the subject will not likely complete the task in the time allotted, then the task can be called off. Higher scores indicate poorer cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||seconds||Standard Deviation|Mean
39421|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Stroop Task|The Stroop evaluates patients for cognitive functioning. Patients are to read words aloud or name colors as quickly as possible in a 45-second period. The measure contains three tasks, each associated with a subscale as follows: Word, Color, and Color-Word. Each subscale contains 100 items. The raw score range for each of the subscales is 0-100. Each raw subscale score is converted to a T-Score. The possible T-Score range for the Word subscale is 15 to 85. The possible T-Score range for the Color subscale is 8 to 92. The possible T-Score range for the Color-Word subscale is 3 to 98. Higher scores on the subscales indicate better cognitive functioning. Subscales are scored independently and are not added to produce a total score.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.||T-Score||Standard Deviation|Mean
39422|NCT01460290|Secondary|Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
39423|NCT01460290|Secondary|Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline MADRS score of 16 or greater were analyzed. LOCF||units on a scale||Standard Deviation|Mean
39424|NCT01460290|Secondary|Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
39425|NCT01460290|Secondary|Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.||units on a scale||Standard Deviation|Mean
39426|NCT01460290|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)|"The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.~The CGI-BP has three scores - Mania Severity, Depression Severity, and Overall Bipolar Illness Severity."|Baseline and 12 weeks|Intention To Treat (ITT) and LOCF||units on a scale||Standard Deviation|Mean
39427|NCT01460290|Primary|Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline YMRS score of 12 or greater were analyzed. LOCF||units on a scale||Standard Deviation|Mean
39428|NCT01460290|Primary|Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with baseline HAM-D score of 8 or greater were analyzed. Last Observational Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
39440|NCT01459783|Secondary|Change in Caregiver Quality of Life at 6 and 12 Months|The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.|0, 6 and 12 months||||||
39429|NCT01459913|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 48|Safety set included all subjects who received at least 1 dose of study drug.||participants|||Number
39430|NCT01459913|Secondary|Number of Subjects With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 4 and Week 12|FA Set.||participants|||Number
39431|NCT01459913|Secondary|Number of Subjects With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 4|FA Set.||participants|||Number
39432|NCT01459913|Secondary|Percentage of Subjects With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.|Baseline up to Week 48|FA Set.||percentage of participants|||Number
39433|NCT01459913|Secondary|Percentage of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up|FA Set.||percentage of participants|||Number
39434|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)|SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 72|FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to ‘Study Terminated by the Sponsor’ are excluded from this analysis.||percentage of participants|||Number
39435|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|24 weeks after last planned dose of study drug (up to Week 48)|FA Set.||percentage of participants|||Number
39436|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)|SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|4 weeks after last planned dose of study drug (up to Week 28)|FA Set.||percentage of participants|||Number
39437|NCT01459913|Primary|Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|12 weeks after last planned dose of study drug (up to Week 36)|Full Analysis (FA) Set.||percentage of participants|||Number
39438|NCT01459783|Secondary|Change in Process Measures of Dementia Care Quality at 6 and 12 Months|The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.|0, 6 and 12 months||||||
39439|NCT01459783|Secondary|Change in Care Recipient Quality of Life at 6 and 12 Months|The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.|0, 6 and 12 months||||||
39442|NCT01459783|Primary|Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months|The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues. The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week. Higher RMBPC scores mean worse memory/behavior problems. The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.|0, 6 and 12 months|||units on a scale||Standard Deviation|Mean
39443|NCT01459783|Primary|Change in Caregiver Burden at 6 and 12 Months|The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Originally a 29-item instrument, the 22-item modified version is easily completed by telephone. This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden. Higher Zarit scores indicate greater caregiver burden. The minimum possible score is 0, and the maximum possible score is 110.|0, 6 and 12 months|||units on a scale||Standard Deviation|Mean
39444|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|2.5 weeks (or after treatment session 5)||||||
39445|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 10 (week 5)||||||
39446|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 9 (week 5)||||||
39447|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 8 (week 4)||||||
39448|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 7 (week 4)||||||
39449|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 6 (week 3)||||||
39450|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 5 (week 2.5)||||||
39451|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 4 (week 2)||||||
39452|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 3 (week 2)||||||
39453|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 2 (week 1)||||||
39454|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 10 (week 5)||||||
39455|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 9 (week 5)||||||
39456|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 8 (week 4)||||||
39457|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 7 (week 4)||||||
39458|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 6 (week 3)||||||
39459|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 5 (week 2.5)||||||
39460|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 4 (week 2)||||||
39461|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 3 (week 2)||||||
39462|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 2 (week 1)||||||
39463|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 10 (week 5)||||||
39464|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 9 (week 5)||||||
39465|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 8 (week 4)||||||
39466|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 7 (week 4)||||||
39467|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 6 (week 3)||||||
39468|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 5 (week 2.5)||||||
39497|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|26 Week follow up||||||
39498|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|12 Week follow up||||||
39499|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|5 weeks (or after treatment session 10)||||||
39500|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|2.5 weeks (or after treatment session 5)||||||
39501|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|26 Week follow up||||||
39502|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|12 Week follow up||||||
39503|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|5 weeks (or after treatment session 10)||||||
39504|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|2.5 weeks (or after treatment session 5)||||||
39505|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|26 Week follow up||||||
39506|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|12 Week follow up||||||
39507|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|5 weeks (or after treatment session 10)||||||
39508|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|26 week follow up||||||
39509|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|12 week follow up||||||
39510|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|2.5 weeks (or after treatment session 5)||||||
39511|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|5 weeks (or after treatment session 10)||||||
39512|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|2.5 weeks (or after treatment session 5)||||||
39513|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 1 (week 1)||||||
39514|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 1 (week 1)||||||
39515|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 1(week 1)||||||
39516|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 1 (week 1)||||||
39517|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Screening Visit (Day 1)||||||
39518|NCT01459705|Secondary|Behavior and Sympton Identification Scale (BASIS-24)|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)||||||
39519|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|Screening Visit(Day 1)||||||
39520|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)||||||
39521|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|Screening Visit(Day 1)||||||
39522|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|Screening Visit(Day 1)||||||
39523|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|Screening Visit(Day 1)||||||
39524|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|Screening Visit (Day 1)||||||
39525|NCT01459705|Secondary|PTSD Checklist- Civilian (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|Screening Visit (Day 1)||||||
39526|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|26 Week follow up|||units on a scale||Standard Deviation|Mean
40465|NCT01451398|Secondary|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population||percentage of participants|||Number
39527|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|12 week follow up|||units on a scale||Standard Deviation|Mean
39528|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|5 weeks (or after treatment session 10)|Participants who provided outcome data at post treatment||units on a scale||Standard Deviation|Mean
39529|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|2.5 weeks (or after treatment session 5)|Participants who provided data at mid treatment||units on a scale||Standard Deviation|Mean
39530|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|Screening Visit (Day 1)|Baseline scores on the CAPS-W (last week reference)||units on scale||Standard Deviation|Mean
39531|NCT01459653|Secondary|Patient-level Predictor for Cancer-related Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006 in all patients and those with break-through FN episodes.~Table presents patient level predictors for cancer-related mortality: female gender, poor performance (ECOG >=2) during study.~ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data||participants|||Number
39532|NCT01459653|Primary|Incidence of Outcomes|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample||percentage of participants|||Number
39533|NCT01459653|Primary|EP2006 Cycles by Treatment Duration|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration||cycles|Participants||Number
39534|NCT01459653|Primary|EP2006 Day of Initiation: Cycle Distribution|"Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.~Table presents number of cycles by day after chemotherapy."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of study drug initiation||cycles|Participants||Number
39535|NCT01459653|Secondary|Patient-level Predictors for All-cause Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes.~Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG >=2) during study"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data||participants|||Number
39536|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score. H/o repeated infections refers at enrollment; H/o: History of"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in evaluable sample with composite outcome data||participants|||Number
39537|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients from evaluable sample with composite outcome data||cycles|Participants||Number
39538|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related chemotherapy disturbance data||cycles|||Number
39539|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with data||cycles|Participants||Number
39540|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related hospitalization data||participants|||Number
39541|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with CIN/FN-related hospitalization data||cycles|Participants||Number
39542|NCT01459653|Secondary|Modeling FN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with FN episode data||participants|||Number
39550|NCT01459653|Primary|Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.~Mean and standard error estimated from ANCOVA"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample||participants|Participants||Number
40000|NCT01456143|Primary|Sensitivity|Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
39543|NCT01459653|Secondary|Modeling FN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with FN episode data||cycles|Participants||Number
39544|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are shown in the statistical appendices.~H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data||participants|||Number
39545|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are added as statistical analyses appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample with any grade 4 CIN data||cycles|Participants||Number
39546|NCT01459653|Secondary|Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for liver, renal and/or cardiovascular disease."||participants|||Number
39547|NCT01459653|Secondary|Characteristics of Clusters: History of Antibiotic Use for CIN|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~CIN=Chemotherapy Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for history of antibiotic use for CIN."||participants|||Number
39548|NCT01459653|Secondary|Characteristics of Clusters: Cancer Stage|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for cancer stage."||participants|||Number
39549|NCT01459653|Secondary|Characteristics of Clusters: ECOG Performance Status|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982.~FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for ECOG performance status."||Scores on a scale||Standard Deviation|Mean
39551|NCT01459653|Primary|Predictors of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.~Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used.~Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb~Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles for patients in evaluable sample with data||participants|Participants||Number
39552|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients with any CIN/FN-related chemotherapy disturbances by treatment decision.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by treatment decision with data||participants|||Number
39553|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients with any CIN/FN-related chemotherapy disturbance by prophylaxis type.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type||participants|||Number
39554|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients who had a cancer-related death by any/no CIN/FN-related chemotherapy disturbance~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data||participants|||Number
39555|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients that had a cancer-related death by any/no grade 4 CIN or FN~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN or FN with data||participants|||Number
39556|NCT01459653|Primary|Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table shows number of patients who died by any or no CIN/FN related chemotherapy disturbance.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any or no CIN/FN related chemotherapy disturbance.||participants|||Number
39557|NCT01459653|Primary|Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table shows number of patients that died in each group.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN/FN||participants|||Number
39589|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 3||days|Participants|Standard Deviation|Mean
39558|NCT01459653|Primary|Number of Patients by Cause of Death|Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Safety population, i.e. all patients who received at least one dose of study drug||participants|||Number
39559|NCT01459653|Primary|Incidence of Outcomes by Study Drug Duration: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level by study drug duration. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug duration. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.||percentage of participants|||Number
39560|NCT01459653|Primary|Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level by day of study drug initiation. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010). *Day of EP2006 initiation- Day 0 (during chemotherapy); **Day of EP2006 initiation- Days 1-3 (per guidelines)"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.||percentage of participants|||Number
39561|NCT01459653|Primary|Incidence of Outcomes: Cycles Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||Percentage of participants|||Number
39562|NCT01459653|Primary|Incidence of Outcomes by Mean GIS: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes by day (mean GIS over all visits). ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by mean GIS||percentage of participants|||Number
39563|NCT01459653|Primary|Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug dose||percentage of participants|||Number
39572|NCT01459653|Primary|GCSF Persistence Score (GPS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in the evaluable sample with a GCSF persistence score (GPS).||participants|||Number
39564|NCT01459653|Primary|Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis decision (relative to guidelines)||percentage of participants|||Number
39565|NCT01459653|Primary|Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type||Percentage of participants|||Number
39566|NCT01459653|Primary|Incidence of Outcomes by Chemotherapy Risk: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by chemotherapy risk||percentage of participants|||Number
39567|NCT01459653|Primary|CIN/FN Episodes: Cycle Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.~Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization [RH] or CIN/FN-related chemotherapy disturbance [RCD])"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample||cycles|Participants||Number
39568|NCT01459653|Primary|Number of Patients With CIN/FN Episodes: Patient Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance)~A patient may fall into more than one or none of the categories displayed."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||participants|||Number
39569|NCT01459653|Primary|Absolute Neutrophil Count (ANC) Across All Cycles|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||Per mm^3|Participants|Standard Deviation|Mean
39570|NCT01459653|Primary|Absolute Neutrophil Count (ANC) at EP2006 Initiation|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of patients in evaluable sample with initial ANC result||Per mm^3||Standard Deviation|Mean
39571|NCT01459653|Primary|GCSF Congruence Score (GCS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The GCS is computed at the patient level as an overall grade of how congruent actual GCSF treatment is to recommended treatment. The GCS is computed as follows and scores range from 0 to 3: GCS = Σ(CRS + mean GIS over all cycles + GPS), with higher scores indicating higher congruence.~CRS: Chemotherapy Risk Score (0 or 1 with 1 best); FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS=GCSF Initiation Score (0 to 1 with 1 best); GPS=GCSF persistence score (0 to 1 with 1 best);"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with GCSF congruence score by tumor type||scores on a scale||Standard Deviation|Mean
39573|NCT01459653|Primary|GCSF Initiation Score (GIS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~ANC=Absolute Neutrophil Count; GIS Score 0 (EP2006 initiated on day 0 of chemotherapy or on day 10 or later); GIS Score 0.50 (EP2006 initiated on days 7-9 of chemotherapy); GIS Score 0.75 (EP2006 initiated on days 4-6 of chemotherapy); GIS Score 1.00 (EP2006 initiated per EORTC guidelines (2010) on days 1-3 after chemotherapy)~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor; GIS=Granulocyte Colony-Stimulating Factor Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)||Percent of participants|||Number
39574|NCT01459653|Primary|EP2006 Day of Initiation Relative to Guidelines by Cancer Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines~DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles with initiation on different days during chemotherapy for evaluable sample. A patient may have initiated EP2006 during chemotherapy on different days for different cycles. The categories therefore are not mutually exclusive on a patient level and the sum of patients may therefore exceed the sample size.||cycles|Participants||Number
39575|NCT01459653|Primary|Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient’s chemotherapy toxicity (<10%, 10–20% or >20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample: total and by tumor type||percentage of patients|||Number
39576|NCT01459653|Primary|Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~FN: Febrile Neutropenia; EORTC: European Organisation for Research and Treatment of Cancer"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||percentage of participants|||Number
39577|NCT01459653|Primary|Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).~Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type||Scores on a scale||Standard Deviation|Mean
39578|NCT01459653|Primary|Patient Risk Score (PRS) for All Patients|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).~Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample||Scores on a scale||Standard Deviation|Mean
39615|NCT01459653|Primary|Concomitant Antibiotic Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||participants|||Number
39579|NCT01459653|Secondary|Characteristics of Clusters: Hemoglobin Study Start|Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for hemoglobin at study start."||g/dL||Standard Deviation|Mean
39580|NCT01459653|Secondary|Cohort Identification|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the “high risk group” comprised of only 3.0% of the evaluable sample.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).||participants|||Number
39581|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10–20% at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy risk 10–20% in evaluable sample||percentage of patients|||Number
39582|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010).~CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample||percentage of participants|||Number
39583|NCT01459653|Primary|EP2006 Duration by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
39584|NCT01459653|Primary|EP2006 Duration by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
39585|NCT01459653|Primary|EP2006 Duration by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type with data||days|Participants|Standard Deviation|Mean
39586|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 6||days|Participants|Standard Deviation|Mean
39587|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 5||days|Participants|Standard Deviation|Mean
39588|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 4||days|Participants|Standard Deviation|Mean
39590|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 2||days|Participants|Standard Deviation|Mean
39591|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 1||days|Participants|Standard Deviation|Mean
39592|NCT01459653|Primary|EP2006 Treatment Duration in Any Cycle|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration||days|Participants|Standard Deviation|Mean
39593|NCT01459653|Primary|EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
39594|NCT01459653|Primary|EP2006 Day of Initiation by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
39595|NCT01459653|Primary|EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||days|Participants|Standard Deviation|Mean
39596|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 6||days|Participants|Standard Deviation|Mean
39597|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 5||days|Participants|Standard Deviation|Mean
39598|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 4||days|Participants|Standard Deviation|Mean
39599|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 3||days|Participants|Standard Deviation|Mean
39600|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 2||days|Participants|Standard Deviation|Mean
39601|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 1||days|Participants|Standard Deviation|Mean
39616|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Tumor Type|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type||participants|||Number
39602|NCT01459653|Primary|EP2006 Day of Initiation: All Cycles|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of initiation of study drug||days|Participants|Standard Deviation|Mean
39603|NCT01459653|Primary|EP2006 Dose by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||cycles|Participants||Number
39604|NCT01459653|Primary|Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type||participants|||Number
39605|NCT01459653|Primary|EP2006 Dose by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|||cycles|Participants||Number
39606|NCT01459653|Primary|EP2006 Dose by Patient Weight: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles treated||cycles|Participants||Number
39607|NCT01459653|Primary|EP2006 Dose (Cycle 6)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 6 with dose data||participants|||Number
39608|NCT01459653|Primary|EP2006 Dose (Cycle 5)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 5 with dose data||participants|||Number
39609|NCT01459653|Primary|EP2006 Dose (Cycle 4)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 4 with dose data||participants|||Number
39610|NCT01459653|Primary|EP2006 Dose (Cycle 3)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 3 with dose data||participants|||Number
39611|NCT01459653|Primary|EP2006 Dose (Cycle 2)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 2 with dose data||participants|||Number
39612|NCT01459653|Primary|EP2006 Dose (Cycle 1)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 1 with dose data||participants|||Number
39613|NCT01459653|Primary|EP2006 Dose (Enrollment Cycle)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at enrollment cycle with dose data||participants|||Number
39614|NCT01459653|Primary|EP2006 Dose (All Cycles)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample||cycles|Participants||Number
39640|NCT01459016|Secondary|Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir|Composite summary standardized uptake value ratio (SUVR) normalized to mean whole cerebellum. Regions used for composite summary were posterior cingulum, anterior cingulum, parietal cortex, lateral temporal cortex and frontal cortex.|Baseline|All participants with an amyloid positive florbetapir F 18 PET scan at baseline.||SUVR unit 1||Standard Deviation|Mean
39617|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Age Group|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by age||participants|||Number
39618|NCT01459653|Primary|Type of EP2006 Prophylaxis by Gender|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by gender||participants|||Number
39619|NCT01459653|Primary|Type of EP2006 Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|"Delayed Primary: EP2006 initiated in cycle 2 or later with no CIN/FN in prior cycle.~True secondary: EP2006 initiated in cycle 2 or later following CIN/FN in prior cycle."||participants|||Number
39620|NCT01459653|Primary|Clinical Events Ever During Study (Frequency Threshold: 5%)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)||participants|||Number
39621|NCT01459653|Primary|Fever and Infections Ever During the Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).||participants|||Number
39622|NCT01459653|Primary|Cancer Treatment Type - Ever Received During Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).||participants|||Number
39623|NCT01459653|Primary|Chemotherapy Toxicity (%FN Risk)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~Chemotherapy regimens were classified for FN risk (<10% risk, 10-20% risk or >20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data. Please refer to baseline characteristics tables as well.||participants|||Number
39624|NCT01459588|Secondary|Change From Baseline in Schirmer Test Results|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.||millimeters||Standard Deviation|Mean
39637|NCT01459016|Secondary|Change From Baseline in the Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.||units on a scale||95% Confidence Interval|Least Squares Mean
39625|NCT01459588|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Score on as scale||Standard Deviation|Mean
39626|NCT01459588|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
39627|NCT01459588|Secondary|Change From Baseline in Tear Break-up Time|Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Seconds||Standard Deviation|Mean
39628|NCT01459588|Primary|Change From Baseline in Ocular Surface Disease Index© Questionnaire Score|The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
39629|NCT01459068|Secondary|Alcohol Use|Alcohol use was measured using the Alcohol Use Disorders Identification Test (AUDIT). Respondents reported frequency and amount of alcohol consumed, referencing photographs of local alcohols (local beers, rice whiskeys, etc.). Total scores were calculated as sum totals across the 10-item scale. AUDIT total scores ranged from 0 (best possible outcome) to 40 (worst possible outcome).|10-16 weeks|||units on a scale||Standard Error|Mean
39630|NCT01459068|Secondary|Aggression Behaviors|The 12-item Aggression Questionnaire (AQ) was adapted for local use. Respondents rated frequency in general of aggressive behaviors from 0 “None of the time” to 4 “Almost all of the time.” Scores were calculated as averages scores for each behavior across the 12-item scale and therefore ranged from 0-4|10-16 weeks|||units on a scale||Standard Error|Mean
39631|NCT01459068|Secondary|Anxiety Symptoms|Anxiety symptoms were measured using the 10-item HSCL-25 anxiety subscale with local adaptations. Respondent instructions and response categories were the same as the HSCL-25 depression subscale. Scores were calculated as average symptom scores across the 11-item scale and therefore ranged from 0-4|10-16 weeks|||units on a scale||Standard Error|Mean
39632|NCT01459068|Primary|Posttraumatic Stress Symptoms|Posttraumatic stress symptoms (PTSS) were measured using the 30-symptom items of the Harvard Trauma Questionnaire (HTQ). Response options were the same as the HSCL-25. An algorithm was applied to the HTQ to determine eligibility on the basis of moderate to severe PTSS. The HTQ was also used to measure the PTSS severity outcome: Scores for PTSS were calculated as average symptom scores across the 30 items. PTSS scores ranged from 0 (best possible outcome) to 3 (worst possible outcome).|10-16 weeks|||units on a scale||Standard Error|Mean
39633|NCT01459068|Secondary|Functional Impairment|Functional impairment was measured using locally-developed, gender-specific scales. The scales contained 16 and 23 tasks for men and women, respectively. Respondents reported current difficulty compared to others of same gender and similar age (from 0 “No difficulty” to 4 “Often cannot do”). Scores were calculated as average task scores across the 16- and 23-item scales and therefore ranged from 0-4|10-16 weeks|||units on a scale||Standard Error|Mean
39634|NCT01459068|Primary|Depression|Depression symptoms were measured using a modified, locally validated version of the 15-item Hopkins Symptoms Checklist (HSCL-25) depression subscale. Respondents reported symptom frequency in the last month (0 “None of the time” to 3 “Almost always”). An algorithm was applied to the HSCL-25 to determine eligibility on the basis of moderate to severe depression. The HSCL-25 was also used to measure the depression severity outcome: Scores on the depression scale were calculated as average symptom scores across the 17 items and therefore ranged from 0-3|10-16 weeks|||units on a scale||Standard Error|Mean
39635|NCT01459016|Secondary|Change From Baseline in the Clinical Dementia Rating (CDR) Total Score|The CDR is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score ranges from 0 to 18. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.||units on a scale||95% Confidence Interval|Least Squares Mean
39636|NCT01459016|Secondary|Change From Baseline in the Alzheimer’s Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.||units on a scale||95% Confidence Interval|Least Squares Mean
39638|NCT01459016|Secondary|Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T||Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||participants|||Number
39639|NCT01459016|Secondary|Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)||Baseline|All participants who had an MRI during screening and were classified as screen failures.||participants|||Number
39641|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)|DTI scans used MD to measure the overall magnitude of water diffusion in selected WM tracts, without specific regard to directionality. ROI: CC, IC, PCB, TWM, UF, SLF. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||square meters per second (m²/sec) * 10¹⁰||95% Confidence Interval|Least Squares Mean
39642|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)|DTI scans used FA to measure water diffusion directionality in selected white matter (WM) tracts. ROI: Corpus collosum (CC), internal capsule (IC), posterior cingulum bundle (PCB), temporal white matter (TWM), uncinate fasciculus (UF), superior longitudinal fasciculus (SLF). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||au||95% Confidence Interval|Least Squares Mean
39643|NCT01459016|Primary|Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)|Distributed functional connectivity in selected brain networks was calculated from the rsfMRI scans. Values were derived from low-frequency (0.01-0.1 hertz [Hz]) temporal correlations between different regions over the approximately 6-minute rsfMRI time series scan. Distributed measures of functional connectivity were calculated as the mean Pearson correlation between the average low-frequency time courses in predefined sets of regions of interest (ROI) within the default mode network (DMN), salience network (SN) and sensorimotor networks (SMN). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||arbitrary units (au)||95% Confidence Interval|Least Squares Mean
39644|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)|Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||percentage of hippocampus volume average||95% Confidence Interval|Least Squares Mean
39645|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)|BBSI and VBSI were calculated based on the voxel-wise difference between co-registered baseline and follow-up scans. Least squares (LS) mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.||milliliters (mL)||95% Confidence Interval|Least Squares Mean
39646|NCT01458951|Secondary|Change From Baseline in Total Mayo Score at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Baseline, Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
39647|NCT01458951|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in Partial Mayo scores at Weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each graded from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Error|Least Squares Mean
39648|NCT01458951|Secondary|Partial Mayo Scores|A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
39649|NCT01458951|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39650|NCT01458951|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39677|NCT01458587|Secondary|Edema at Visit 5|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT||participants|||Number
39651|NCT01458951|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39652|NCT01458951|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39653|NCT01458951|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39654|NCT01458951|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39655|NCT01458951|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.||percentage of participants|||Number
39656|NCT01458639|Secondary|Safety of Technegas in Patients With Possible PE|Safety will be assessed by the incidence of treatment emergence adverse events and changes in clinical laboratory measurements, blood pressure, oxygen saturation, physical examination and pulmonary examination before and after treatment.|Prospective, from enrollment through 30 days follow-up|All subjects who received Technegas and completed safety follow-up procedures.||participants|||Number
39657|NCT01458639|Secondary|Likelihood Ratio for Diagnosis of PE|Likelihood ratios of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
39658|NCT01458639|Secondary|Negative Predictive Value (NPV) of Imaging for Diagnosis of PE|NPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
39659|NCT01458639|Secondary|Positive Predictive Value (PPV) of Imaging for Diagnosis of PE|PPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
39660|NCT01458639|Secondary|Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE|Accuracy of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|prospective, 30 days follow-up.|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
39661|NCT01458639|Primary|Specificity of Technegas V/Q SPECT for the Diagnosis of PE.|"Compared to the specificity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
39662|NCT01458639|Primary|Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE|"Compared to the sensitivity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.|||||
39663|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT observed||participants|||Number
39664|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT observed||participants|||Number
39665|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2 after PDT #1|ITT observed||participants|||Number
39666|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT observed||participants|||Number
39667|NCT01458587|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks Post PDT #1|ITT observed||participants|||Number
39668|NCT01458587|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks Post PDT #1|ITT observed||participants|||Number
39669|NCT01458587|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks Post PDT #1|ITT observed||participants|||Number
39670|NCT01458587|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT observed||participants|||Number
39671|NCT01458587|Secondary|Stinging/Burning at Visit 5|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT, observed||participants|||Number
39672|NCT01458587|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT, observed||participants|||Number
39673|NCT01458587|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT, observed||participants|||Number
39674|NCT01458587|Secondary|Stinging/Burning Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT, observed||participants|||Number
39675|NCT01458587|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT, observed||participants|||Number
39676|NCT01458587|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT, observed||participants|||Number
39678|NCT01458587|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT||participants|||Number
39679|NCT01458587|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 Weeks after PDT #1|ITT||participants|||Number
39680|NCT01458587|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT #1|ITT||participants|||Number
39681|NCT01458587|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT||participants|||Number
39682|NCT01458587|Secondary|Erythema at Visit 5|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT||participants|||Number
39683|NCT01458587|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT||participants|||Number
39684|NCT01458587|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT||participants|||Number
39685|NCT01458587|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT #1|ITT||participants|||Number
39686|NCT01458587|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT||participants|||Number
39687|NCT01458587|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|12 Weeks after PDT #1|ITT||participants|||Number
39688|NCT01458587|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|8 Weeks after PDT #1|ITT||participants|||Number
39689|NCT01458587|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|2 Weeks after PDT #1|ITT||participants|||Number
39690|NCT01458587|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Baseline|ITT||participants|||Number
39691|NCT01458587|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 weeks after PDT #1|ITT||participants|||Number
39692|NCT01458587|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 weeks after PDT #1|ITT||participants|||Number
39693|NCT01458587|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 weeks after PDT #1|ITT||participants|||Number
39694|NCT01458587|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT||participants|||Number
39695|NCT01458587|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|ITT||participants|Participants||Number
39696|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 12|ITT LOCF||arms >75% cleared|Participants||Number
39697|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 8|ITT LOCF||arms >75% cleared|Participants||Number
39698|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 12|ITT LOCF||arms 100% cleared|Participants||Number
39699|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 8|ITT LOCF||arms 100% cleared|Participants||Number
39700|NCT01458587|Secondary|Lesion Clearance Rate||Week 8|ITT LOCF||percentage of lesions cleared|Participants|Standard Deviation|Median
39701|NCT01458587|Primary|Lesion Clearance Rate|Clearance rate for all lesions|Week 12|ITT analysis with LOCF||percentage of lesions cleared|Participants|Standard Deviation|Median
39702|NCT01458561|Secondary|Number of Procedure Complications and/or Adverse Events||Through final follow-up (2 years postoperatively)|||Number of complications and AEs|||Number
39703|NCT01458561|Secondary|Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers|Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points|Preoperatively (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postoperatively, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yr postop|Blood samples were to be analyzed in batches to more accurately assess for any changes over time; the study was terminated before the first batch was analyzed, so no data is available for anti-BSA titer testing.|||||
39704|NCT01458561|Secondary|Subjects Requiring Additional Hospitalization/Surgical Intervention|Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up|Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm||# of participants|||Number
39705|NCT01458561|Secondary|Total Hospitalization Time|Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)|Hospital admission (day of surgery) until hospital discharge (average 5-7 days)|Study terminated before any subjects were enrolled into the BioFoam arm||days|||Number
39706|NCT01458561|Secondary|Core Body Temperature||At the time of test or control article application (expected average 3-4 hours from skin cut)|Study terminated before any subjects were enrolled into the BioFoam arm||degrees Celcius|||Number
39707|NCT01458561|Secondary|Total Time of Operative Procedure||Skin cut to skin closure (average 4-5 hour duration)|Study terminated before any subjects were enrolled into the BioFoam arm||minutes|||Number
39708|NCT01458561|Secondary|Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)|Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)|After final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm||number of participants|||Number
39709|NCT01458561|Secondary|Eval. for Presence of Device by MRI w/ & w/Out Contrast, & Diagnose/Eval. Abdominal Fluid Collection/Biliary Leak, Residual Scarring, Hepatic Regeneration, & Assess for Emergence of Primary/Recurrent Malignancy by MRI w/ or w/Out Contrast as Appropriate||Within 48 hours postoperatively, up to 48 hours prior to hospital discharge (avg. 5-7 days postoperatively), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively|||participants|||Number
39710|NCT01458561|Secondary|Subject Laboratory Evaluations|Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up|Preoperatively through final 2 year follow-up|Study terminated before any subjects were enrolled into the BioFoam arm||Number of participants with labs in rang|||Number
39711|NCT01458561|Secondary|Amount of Intraoperative Blood Products Administered|Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)|Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)|Study terminated before any subjects were enrolled into the BioFoam arm||units of blood product(s)|||Number
39712|NCT01458561|Secondary|Duration of Drainage|Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm||hours|||Number
39713|NCT01458561|Secondary|Amount of Postoperative Fluid Loss|Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]|Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm||milliliters (mL)|||Number
39714|NCT01458561|Secondary|Amount of Postoperative Bilious Drainage||Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm||milliliters (mL)|||Number
39715|NCT01458561|Secondary|Intraoperative Blood Loss|Amount of blood lost between time of initial application of prescribed hemostatic agent and confirmed achievement of hemostasis (achievement of hemostasis eval. out to 10 minutes following application of prescribed hemostatic agent)|Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)|Study terminated before appropriate data collection/analysis|||||
39716|NCT01458561|Secondary|Achievement of Immediate Hemostasis|Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent|1 minute after application of prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm||participants|||Number
39717|NCT01458561|Secondary|Time to Hemostasis|"Number of subjects achieving hemostasis [by assessing for hemostasis (yes/no)] at pre-determined time points: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent. Time to hemostasis is recorded as the first of the predetermined time points to receive a yes assessment."|1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent|Study terminated before any subjects were enrolled into the BioFoam arm||minutes|||Number
39718|NCT01458561|Primary|Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent|Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent|3 minutes following a single application of the prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm||participants|||Number
39719|NCT01458535|Secondary|Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)|Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 48|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.||percentage of participants|||Number
39720|NCT01458535|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
39721|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
39722|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
39723|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
39724|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
39725|NCT01458535|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||percentage of participants|||Number
39726|NCT01458288|Secondary|the Pharmacodynamics (PD) of TG-0054|To evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.|pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.||||||
39727|NCT01458288|Secondary|the Safety of TG-0054 in Patients With MM, NHL or HD|To evaluate the safety of TG-0054 in patients with MM, NHL or HD All adverse events will be coded according to the MedDRA dictionary, and be limited to events related or not related to study drug.|1 month||||||
39728|NCT01458288|Secondary|the Average Number of Leukapheresis Sessions|To determine the average number of leukapheresis sessions required to collect 2.5 x106 CD34+ cells/kg.|1 week||||||
39729|NCT01458288|Primary|Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg|"Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD).~Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8."|1 week|||participants|||Number
39730|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3|||Percentage of participants|||Number
39731|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3|||participants|||Number
39732|NCT01458275|Secondary|Treatment-emergent AEs Causing Study Medication Discontinuation||Weeks 0 - 3|||participants|||Number
39733|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3|||Percentage of participants|||Number
39734|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3|||participants|||Number
39735|NCT01458275|Secondary|Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.|Weeks 0 - 2|||Days|||Number
39736|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement"|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
39737|NCT01458275|Secondary|Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
39738|NCT01458275|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
39739|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
39740|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment||units on a scale||Standard Error|Least Squares Mean
39758|NCT01458171|Secondary|Number of Days of Hospitalization Due to Infections.|Median number of days of hospitalization due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||days||Full Range|Median
40001|NCT01456143|Primary|Accuracy|Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
39741|NCT01458275|Primary|Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatmentgroup with completed assessment||units on a scale||Standard Error|Least Squares Mean
39742|NCT01458249|Secondary|Best Overall Response (BOR)|The best overall response categories (CR, PR, SD [including non-CR/non-PD], PD, not evaluable [NE], and unknown [UNK]) were derived based on time point tumor responses during the study as assessed by the IRC as well as the investigator. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. BOR of SD must have occurred at least 35 days (at least 5 weeks) after the first dose of study drug. If a participant had a BOR of non-CR/non-PD, the participant's BOR was grouped with the SD category.|Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants|||Number
39743|NCT01458249|Secondary|Durable Stable Disease (SD) Rate (dSDR)|Durable stable disease rate was defined as the percentage of participants who manifested durable stable disease (the duration of stable disease for greater than or equal to eleven weeks) and was estimated based on the tumor response assessments performed according to RECIST v1.1. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. A 2-sided 95% CI was calculated using the exact method of binomial distribution.|Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
39744|NCT01458249|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who had a BOR of CR + PR + dSD (duration of SD greater than or equal to 11 weeks [77 days] after the first dose of study treatment). Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. For participants whose BOR was SD, the duration of SD was defined as the time from the date of the first dose of study treatment to the first documented PD or death, whichever occurred first (i.e., same definition of PFS). If the dSD was censored at a time less than 11 weeks, the participant was considered as not having a clinical benefit. A 95% CI was calculated using exact method of binomial distribution.|First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
39745|NCT01458249|Secondary|Disease Control Rate (DCR)|Disease control rate was defined as the percentage of participants who had BOR of CR + PR + SD. BOR of SD must have manifested at least five weeks (35 days) after the first dose of study treatment. Tumor assessment was performed at Week 6 and Week 12 after the start of treatment, and every six weeks thereafter. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started. A 95% CI was calculated using exact method of binomial distribution.|Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
39746|NCT01458249|Secondary|Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants who had a best overall rate (BOR) of CR or PR. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. The BOR of CR and PR in this study required confirmation by a subsequent assessment of response at least four weeks (28 days) later. CR and PR were determined by the Investigator and IRC using RECIST v1.1 for target lesions assessed by MRI/CT scans. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A 95% CI was calculated using exact method of binomial distribution.|Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||95% Confidence Interval|Number
39759|NCT01458171|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||days||Full Range|Median
39747|NCT01458249|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of treatment start to the date of death from any cause. Participants were followed for survival every twelve weeks after PD. In the absence of confirmation of death, participants were censored either at the date that the participant was last known alive or the date of study cutoff, whichever came earlier. Participants censored before database cutoff included those who were lost to follow up and who withdrew consent. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method is used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Months||95% Confidence Interval|Median
39748|NCT01458249|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from the date of treatment start to the first documented date of event (disease progression or death from any cause, whichever occurred first). PFS was assessed every six weeks (until disease progression was confirmed, or sooner, if clinically indicated) and was based on Investigator and Independent Review Committee (IRC) assessments according to RECIST v1.1. Disease progression was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors and defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method was used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Months||95% Confidence Interval|Median
39749|NCT01458249|Primary|Progression-free Rate at 12 Weeks (PFR12wks)|The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution.|Week 12|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).||Percentage of participants||90% Confidence Interval|Number
39750|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen – Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.||hours||Full Range|Median
39751|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen – Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
39752|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
39753|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.||hours||Full Range|Median
39754|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
39755|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
39756|NCT01458171|Other Pre-specified|Rate of Infection Episodes (Serious and Non-serious)|The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the FAS population and the PPS population and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||infection episodes per subject year|Participants||Number
39757|NCT01458171|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||days||Full Range|Median
39823|NCT01457950|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||percentage (%) of mean RBC volume||Standard Deviation|Mean
39760|NCT01458171|Secondary|Number of Infection Episodes (Serious and Non-serious)||24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||infection episodes|||Number
39761|NCT01458171|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||SBIs per subject year|Participants||Number
39762|NCT01458171|Secondary|IgG Trough Level|Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown|24 weeks|The Full Analysis Set (FAS) comprised all subjects receiving at least 1 IgPro20 infusion. The Per Protocol Set (PPS) comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.||g/L||Standard Deviation|Mean
39763|NCT01458171|Secondary|Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'|"Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as “very good”, “good”, “fair”, or “poor”. The reported percentage represents the percentage of subjects with local tolerability assessments of very good or good at any given study infusion."|24 to 72 hours after infusion|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.||percentage of infusions|||Number
39764|NCT01458171|Secondary|Number of Subjects With Newly Developing or Worsening AEs|Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.||participants|||Number
39765|NCT01458171|Secondary|Overall Rate of AEs Per Infusion|The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.||AEs per infusion|Participants||Number
39766|NCT01458171|Primary|Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion|The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The All Treated (AT) set comprised all subjects receiving at least 1 IgPro20 infusion.||AEs per infusion||Full Range|Median
39767|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; Two-stage Chromogenic Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
39768|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; One-stage aPTT Clotting Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||percentage of AUCinf||95% Confidence Interval|Geometric Mean
39769|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
39824|NCT01457950|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
39770|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
39771|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; Two-stage Chromogenic Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
39772|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; One-stage aPTT Clotting Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL||95% Confidence Interval|Geometric Mean
39773|NCT01458106|Secondary|Volume at Terminal Phase (Vz; Two-stage Chromogenic Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
39774|NCT01458106|Secondary|Volume at Terminal Phase (Vz; One-stage aPTT Clotting Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
39775|NCT01458106|Secondary|Lambda Z (Two-stage Chromogenic Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||1/hours||95% Confidence Interval|Geometric Mean
39776|NCT01458106|Secondary|Lambda Z (One-stage aPTT Clotting Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||1/hours||95% Confidence Interval|Geometric Mean
39777|NCT01458106|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
39825|NCT01457950|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Femtoliters (FL)||Standard Deviation|Mean
39778|NCT01458106|Secondary|Time at Maximum Activity (Tmax; One-stage aPTT Clotting Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
39779|NCT01458106|Secondary|Incremental Recovery (IR; Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
39780|NCT01458106|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
39781|NCT01458106|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
39782|NCT01458106|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
39783|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
39784|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
39785|NCT01458106|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
39826|NCT01457950|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Picograms (PG)/cell||Standard Deviation|Mean
39786|NCT01458106|Secondary|Volume at Steady State (Vss; One-stage aPTT Clotting Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
39787|NCT01458106|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/h/kg||95% Confidence Interval|Geometric Mean
39788|NCT01458106|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/h/kg||95% Confidence Interval|Geometric Mean
39789|NCT01458106|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
39790|NCT01458106|Secondary|Elimination Half Life (t1/2; One-stage aPTT Clotting Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
39791|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; Two-stage Chromogenic Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL||95% Confidence Interval|Geometric Mean
39792|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL||95% Confidence Interval|Geometric Mean
39793|NCT01458106|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.||IU/kg|Participants|Full Range|Median
39794|NCT01458106|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.||injections|Participants|Inter-Quartile Range|Median
39795|NCT01458106|Secondary|Number of Days From Last Treatment Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.||days|Participants|Inter-Quartile Range|Median
39796|NCT01458106|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Consumption was calculated overall for all participants and for the last 3 months (91 days) on study, counted backwards from the end of the efficacy period, for participants with at least 24 weeks on study.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and ≥ 24 weeks on study.||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
39797|NCT01458106|Secondary|Physician’s Global Assessment of the Participant’s Response to His rFVIIIFc Regimen|Investigators assessed each participant’s response to his rFVIIIFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFVIIIFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of responses.||percentage of responses|Participants||Number
39798|NCT01458106|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment (provided by the caregiver) of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of first injections for which a response was provided, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within approximately 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had a bleeding episode; participants with a non-evaluable bleed are counted in the number of participants analyzed, but not the percentages.||percent of 1st injections w/ a response|Participants||Number
39799|NCT01458106|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleed=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last inject|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period is of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
39827|NCT01457950|Secondary|Change From Baseline in Hematocrit at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Proportion of RBCs in blood||Standard Deviation|Mean
39800|NCT01458106|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period was of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
39801|NCT01458106|Primary|Occurrence of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥50 EDs to rFVIIIFc. In addition, the incidence for all participants, regardless of their EDs to rFVIIIFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26|Safety Analysis Set: participants who received at least 1 dose of prestudy FVIII, or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
39802|NCT01457950|Other Pre-specified|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.|Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Participants|||Number
39803|NCT01457950|Other Pre-specified|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||Participants|||Number
39804|NCT01457950|Other Pre-specified|Change From Baseline in Red Cell Distribution Width at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||percentage (%) of mean RBC volume||Standard Deviation|Mean
39805|NCT01457950|Other Pre-specified|Change From Baseline in Red Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
39806|NCT01457950|Other Pre-specified|Change From Baseline in Mean Corpuscle Hemoglobin at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||Picograms (PG)/cell)||Standard Deviation|Mean
39807|NCT01457950|Other Pre-specified|Change From Baseline in Hematocrit at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.||Proportion of RBCs in blood||Standard Deviation|Mean
39808|NCT01457950|Other Pre-specified|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
39809|NCT01457950|Other Pre-specified|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Micromole/liter (UMOL/L)||Standard Deviation|Mean
39810|NCT01457950|Other Pre-specified|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
39811|NCT01457950|Other Pre-specified|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
39812|NCT01457950|Other Pre-specified|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Grams (G)/Liter (L)||Standard Deviation|Mean
39813|NCT01457950|Other Pre-specified|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.||Ratio||Standard Deviation|Mean
39814|NCT01457950|Other Pre-specified|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Month 6 to Month 12|ITT-OL Population||Participants|||Number
39815|NCT01457950|Other Pre-specified|Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.||Percent change||Inter-Quartile Range|Median
39816|NCT01457950|Other Pre-specified|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline – measure at Baseline) divided by measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.||Percent change||Inter-Quartile Range|Median
39817|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.||Percent change||Standard Error|Mean
39818|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.||Percent change||Standard Error|Mean
39819|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.||Percent change||Standard Error|Mean
39820|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.||Percent change||Standard Error|Mean
39821|NCT01457950|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.|Month 6|ITT Population. Only participants at the specified time points were analyzed.||Participants|||Number
39822|NCT01457950|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Participants|||Number
39828|NCT01457950|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
39829|NCT01457950|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Micromole/liter (UMOL/L)||Standard Deviation|Mean
39830|NCT01457950|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
39831|NCT01457950|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed. .||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
39832|NCT01457950|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Grams (G)/Liter (L)||Standard Deviation|Mean
39833|NCT01457950|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.||Ratio||Standard Deviation|Mean
39834|NCT01457950|Secondary|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.||Participants|||Number
39835|NCT01457950|Secondary|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline – measure at Baseline) divided by measure at Baseline * 100.|Baseline, Months 1, 3 and 6|ITTE Population. Only participants at the specified time points were analyzed.||Percent change||Inter-Quartile Range|Median
39836|NCT01457950|Secondary|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline, Month 1 and Month 6|ITTE Population||Percent change||Standard Error|Mean
39837|NCT01457950|Secondary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 1|ITTE Population||Percent change||Standard Error|Mean
39838|NCT01457950|Primary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.||Percent change||Standard Error|Mean
39839|NCT01457885|Secondary|Incidence of Relapse||2 years|75 patients were enrolled. One patient was not treated. 3 patients were pediatric and therefore left off of this analysis.||percentage of patients||95% Confidence Interval|Number
39840|NCT01457885|Secondary|The Percentage of Patients Alive at 1 Year|Overall survival was calculated following transplant using a CloBu4 conditioning regimen for patients with non-remission AML|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.||percentage of patients||95% Confidence Interval|Number
39841|NCT01457885|Primary|Cumulative Incidence of Non Relapse Mortality (NRM)|Percentage of patients passed without relapse/recurrence at 1 year.|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.||percentage of patients||95% Confidence Interval|Number
39842|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 2)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH.||IU/L||Standard Deviation|Mean
39843|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 1)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH.||IU/L||Inter-Quartile Range|Mean
39844|NCT01457703|Primary|Changes in Pregnanediol Glucuronide (PdG) (Aim 2)|Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.|Averaged over the length of menstrual cycle|This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG.||ug/cycle||Standard Deviation|Mean
39845|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude.||IU/L||Standard Deviation|Mean
39846|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1.||IU/L||Inter-Quartile Range|Mean
39847|NCT01457521|Primary|11-point Visual Analog Scale for Pain|Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)|1-2 weeks|||units on a scale||Standard Deviation|Mean
39848|NCT01457430|Secondary|Percent Change in VAS Scores|Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity|Percent Change in VAS Score from Baseline to 4 Hours|||percent change||Inter-Quartile Range|Median
39849|NCT01457430|Primary|Time to Complete or Near Complete Resolution From Onset of Symptoms|Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.|Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours|||minutes||Inter-Quartile Range|Median
39850|NCT01457417|Primary|Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|Patients with advanced NSCLC receiving the study drug at 300 mg every 2 weeks in Part B||months||95% Confidence Interval|Median
39851|NCT01457417|Secondary|Objective Response Rate (ORR) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|FAS : For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|FAS : NSCLC - All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. Two patients in treatment group 300 mg Q2W did not have assessments performed after Baseline.||participants||95% Confidence Interval|Number
39852|NCT01457417|Secondary|Objective Response Rate (ORR) in Oncologic Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. One Patients from the 300 mg QW treatment group, and two patients from 300 mg Q2W treatment group did not have assessments performed after Baseline.||Participants||95% Confidence Interval|Number
39853|NCT01457417|Secondary|Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC|For Part B only. OS was defined as the time from the date of signed informed consent to the date of death from any cause. For patients who were still alive as of the data cut-off date, OS time was censored on the date of the patient’s last contact (last contact for patients in post-discontinuation was the last date of contact in long-term follow-up eCRF).|Time from the date of signed informed consent to the date of death from any cause|For patients who are still alive as of the data cut-off date, OS time will be censored on the date of the patient’s last contact (last contact for patients in post-discontinuation = last Date of Contact in Long Term Follow-up eCRF).||Months||95% Confidence Interval|Median
39854|NCT01457417|Secondary|Progression Free Survival (PFS) in Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (i.e, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|All patients who received at least one dose of study treatment during Part A or Part B of the study.||Months||95% Confidence Interval|Median
39855|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth dose for QW groups)|All patients who received at least one dose of study treatment during Part A of the study.||ng/mL||Standard Deviation|Mean
39856|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the first and fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.||ng/mL||Standard Deviation|Mean
39857|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth Dose for QW)|All patients who received at least one dose of study treatment during Part A study.||hr*ng/mL||Standard Deviation|Mean
39858|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.||hr*ng/mL||Standard Deviation|Mean
39859|NCT01457417|Primary|Summary of Patients With Adverse Events (AE)|Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.||Patients|||Number
39860|NCT01457417|Primary|Summary of Total Adverse Events (AE)|Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.||Events|||Number
39861|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
39862|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
39863|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
39864|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
39897|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39865|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
39866|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Arcsine proportion correct||Standard Error|Mean
39867|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39868|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39869|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39870|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39871|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39872|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39873|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39874|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39875|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39876|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39877|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39878|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Log10 milliseconds||Standard Error|Mean
39879|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
39880|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
39881|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
39882|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
39883|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
39884|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||Number of Errors||Standard Error|Mean
39885|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
40002|NCT01456130|Secondary|Change From Baseline in Fasting Glucose|The change in the value of fasting glucose collected at Week 52 or the final visit relative to Baseline.|Baseline and Week 52|Full analysis set.||mg/dL||95% Confidence Interval|Mean
39886|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39887|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39888|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39889|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39890|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39891|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39892|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39893|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39894|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39895|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39896|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
40003|NCT01456130|Secondary|Percentage of Participants With a Clinical Response|Clinical response is defined as an HbA1c level less than 5.8% or less than 6.5% at Week 52 or at the final visit.|Week 52|Full analysis set||percentage of participants||95% Confidence Interval|Number
39898|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39899|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39900|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39901|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39902|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39903|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39904|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39905|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39906|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39907|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39908|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39909|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
40004|NCT01456130|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin collected at Week 52 or at the final visit relative to Baseline.|Baseline and Week 52|Full analysis set: All randomized participants who received at least one dose of double-blind study medication.||percentage of glycosylated hemoglobin||95% Confidence Interval|Mean
39910|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39911|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39912|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39913|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39914|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||units on a scale||Standard Error|Mean
39915|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
39916|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
39917|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
39918|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
39919|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
39920|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
39954|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
40466|NCT01451398|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24||Liters||Standard Deviation|Mean
39921|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
39922|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
39923|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
39924|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||beats/min||Standard Deviation|Mean
39925|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39926|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39927|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39928|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39929|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39930|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39931|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39932|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39933|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39934|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
39935|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng/ml||Standard Deviation|Mean
39936|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
39937|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
39938|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
39939|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
39940|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
39941|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.||ng*hr/ml||Standard Deviation|Mean
39942|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39943|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39944|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
39945|NCT01457053|Primary|Myocardial Blood Flow|Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).|1 - 5 days|No data analyzed due to inadequate enrollment.|||||
39946|NCT01457014|Secondary|Number of Arterial Oxygen Saturation Per Hour|Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|||times per hour||Standard Deviation|Mean
39947|NCT01457014|Secondary|Percent Oxygen Saturation|Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|||percentage of oxygen saturation||Standard Deviation|Mean
39948|NCT01457014|Primary|Number of Sleep Related Events Per Hour|The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|After the Diagnostic Polysomnography (PSG) each participant completed a night in each arm.||events/hour||Standard Deviation|Mean
39949|NCT01456962|Primary|CD4+ to CD8+ T Cell Ratio in Cervical Biopsies|Evaluation of cervical immune health in HIV-infected women on tenofovir (TDF) and emtricitabine (FTC) and either raltegravir or atazanavir. Cervical CD4+ to CD8+ T cell ratios will be measured at one time point from cervical biopsies. Higher ratios will be a measure of better cervical immune health. In addition, ratios will be compared to the concentration of the drug in the genital tract.|Subjects were on treatment from 6 months to 10 years. Subjects were required to be on one of the antiretroviral treatment combinations for at least 6 months for study entry.|||Cervical CD4+:CD8+ T cell ratio||95% Confidence Interval|Geometric Mean
39950|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence (Overall)|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39951|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Psychiatric History Cohort|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39952|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Non-psychiatric History Cohort|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39953|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39998|NCT01456143|Primary|Positive Predictive Value|PPV = proportion of those with a positive test who have neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
39955|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39956|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39957|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39958|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the intent-to-treat (ITT) principle as all randomized participants (N=8144) and was used for all efficacy endpoints.||percentage of participants|||Number
39959|NCT01456936|Secondary|"Clinical Global Impression of Improvement (CGI‑I), No Change Rating by Visit"|"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as normal, not at all ill on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as no change on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs."|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants|||Number
39960|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Overall|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants with positive responses|||Number
39961|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants with positive responses|||Number
39962|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Non-psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants with positive responses|||Number
39963|NCT01456936|Secondary|HADS Total Score (Overall)|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||Units on a scale||Standard Deviation|Mean
39964|NCT01456936|Secondary|HADS Total Score, Psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||Units on a scale||Standard Deviation|Mean
39999|NCT01456143|Primary|Specificity|Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
39965|NCT01456936|Secondary|Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||Units on a scale||Standard Deviation|Mean
39966|NCT01456936|Secondary|Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)|The NPS AE endpoint was the occurrence of at least 1 treatment-emergent “severe” AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent “severe” AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
39967|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
39968|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
39969|NCT01456936|Secondary|Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants|||Number
39970|NCT01456936|Secondary|Occurrence of the Components of NPS AE Primary Endpoint (Overall)|The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
39971|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
39972|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||participants|||Number
39973|NCT01456936|Primary|Estimated NPS AE Rate (%), by Cohort|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants||95% Confidence Interval|Least Squares Mean
39974|NCT01456936|Primary|Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.||percentage of participants|||Number
39975|NCT01456299|Secondary|Frequency of Apnea|If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group|baseline, 30sec after drug injection||||||
39976|NCT01456299|Primary|LMA Insertion Condition|The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.|at that time on LMA insertion only|||participants|||Number
39977|NCT01456195|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)|The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. MTT were only done at sites that had MTT capabilities.||mmol/L||Standard Error|Least Squares Mean
39978|NCT01456195|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.||mg/dL||Standard Error|Least Squares Mean
39979|NCT01456195|Secondary|Incidence of HbA1c <7%|The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.|Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. Last Observation Carried Forward.||percentage of participants|||Number
39980|NCT01456195|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.||percent||Standard Error|Least Squares Mean
39981|NCT01456169|Secondary|Percentage of Participants Who Achieve Both Clinic Systolic and Diastolic Blood Pressure Targets at Week 8|Percentage of participants who achieve both clinic systolic and diastolic blood pressure targets at Week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease) for systolic AND less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease) for diastolic blood pressure.|Week 8|Full analysis set||percentage of participants|||Number
39982|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Diastolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic diastolic blood pressure measured at final visit or week 8, defined as less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease). Diastolic blood pressure is based on the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Week 8|Full analysis set||percentage of participants|||Number
39983|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Systolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic systolic blood pressure measured at final visit or week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease). Systolic blood pressure is the arithmetic mean of the 3 trough sitting Systolic blood pressure measurements.|Week 8|Full analysis set||percentage of participants|||Number
39984|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at final visit or Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39985|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39986|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39987|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39988|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39989|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39990|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39991|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39992|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included||mm Hg||Standard Error|Least Squares Mean
39993|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a baseline and at least 1 post-baseline value of acceptable quality were included.||mm Hg||Standard Error|Least Squares Mean
39994|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change between trough diastolic blood pressure measured at final visit or week 8 relative to baseline Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8|Full analysis set; LOCF was used.||mm Hg||Standard Error|Least Squares Mean
39995|NCT01456169|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline (of the double-blind treatment period) and Week 8|Full analysis set, consisting of all randomized participants who received at least 1 dose of double-blind study drug. A participant was included in the analyses only when there was both a baseline value and at least 1 value during the double-blind treatment period. Last observation carried forward (LOCF) was used.||mm Hg||Standard Error|Least Squares Mean
39996|NCT01456143|Primary|Interrater Reliability|Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||proportion of agreement among 11 experts||95% Confidence Interval|Number
39997|NCT01456143|Primary|Negative Predictive Value|NPV = proportion of those with a negative test without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)|||Percent of images with correct diagnosis||95% Confidence Interval|Mean
40005|NCT01456130|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|52 Weeks|Safety analysis set - All participants who received at least one dose of the investigational product (alogliptin) and a rapid-acting insulin secretagogue.||participants|||Number
40006|NCT01456052|Secondary|Change From Baseline in Total Modified Mayo Score|A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- >4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity.|Baseline to 8 weeks|||units on a scale||Standard Deviation|Mean
40007|NCT01456052|Secondary|Number of Subjects Achieving Clinical Remission|Clinical remission is defined as a total modified Mayo score ≤2 with no individual score >1 at Week 8.|Baseline to 8 weeks|||participants|||Number
40008|NCT01456052|Secondary|Number of Subjects Achieving Clinical Response|Clinical response is defined as a decrease in the total modified Mayo score from baseline of ≥3 or a ≥30% decrease in the total modified Mayo score from baseline, along with a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1 at Week 8.|Baseline to 8 weeks|||participants|||Number
40009|NCT01456052|Primary|Number of Subjects Experiencing a Treatment Emergent Adverse Event||8 weeks|||participants|||Number
40010|NCT01456039|Secondary|Kaplan Meier (K-M) Estimate of Time to Progression (TTP) in PTCL Participants Based on the Modified 2007 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin||days||95% Confidence Interval|Median
40011|NCT01456039|Secondary|Kaplan Meier Estimate of Time to Progression (TTP) in PTCL Participants Based on the 1999 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin||days||95% Confidence Interval|Median
40012|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 2007 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||95% Confidence Interval|Median
40013|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 1999 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||95% Confidence Interval|Median
40014|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 2007 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||Full Range|Median
40015|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 1999 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)||days||Full Range|Median
40016|NCT01456039|Secondary|Percentage of PTCL Participants With the Best Response in Accordance With the Modified 2007 International Workshop Response Criteria as Assessed by IER|Objective disease response in PTCL was defined as achieving a CR or PR based on the Modified 2007 IWC. A CR = a complete disappearance of all disease; lymph node mass regression to normal size on computerized tomography (CT) scan or negative on positron emission tomography (PET); non-palpable splenic and disappearance of liver nodules; infiltrate cleared on repeat bone marrow (BM), immunohistochemistry negative. PR = a reduction of measurable lesions; ≥ 50% decrease in sum of the products of the greatest diameters (SPD) of up to 6 largest dominant masses, no enlargement in size of other nodes; ≥ 50% decrease in SPD and no increase in liver or spleen.|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin||percentage of participants||95% Confidence Interval|Number
40017|NCT01456039|Secondary|The Percentage of Participants With Abnormal Q-wave and T Wave Intervals|The time from the start of the Q-wave to the end of the T-wave QTc intervals greater than 450 msec post-baseline performed by centralized reviewer. The Bazett's (QTcB) and Fridericia (QTcF) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval|Median follow-up: 100 days; up to data cut-off of 28 July 2015|The ECG population includes all participants who received romidepsin on Day 1 of Cycle 1 with at least one post-baseline QTc result||percentage of participants|||Number
40018|NCT01456039|Secondary|Cmax Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Cmax of Romidepsin: accumulation ratio based on Cmax calculated as Cmax,ss/Cmax|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at end of administration) hours after the start of administration, 0.25, 0.5, 1, 2, 4, 6, 20, and 44 hours after the end of administration. Day 8, Cycle 1, samples collected at 0 hour|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ratio||Geometric Coefficient of Variation|Geometric Mean
40019|NCT01456039|Secondary|AUC0-t, Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point; accumulation ratio calculated as AUC (0-t),ss/AUC (0-t)|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ratio||Geometric Coefficient of Variation|Geometric Mean
40020|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1 at Cycle 1, Day 15|The terminal phase half-life of romidepsin after a single dose on Day 15, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Geometric Coefficient of Variation|Geometric Mean
40021|NCT01456039|Secondary|Tmax,ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Observed time to first maximum plasma concentration at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Full Range|Median
40022|NCT01456039|Secondary|Cmax, ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Maximum observed concentration in plasma at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
40023|NCT01456039|Secondary|AUC0-t, at Steady State (ss) of Romidepsin in Phase 1 at Cycle 1, Day 15|Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
40024|NCT01456039|Secondary|Apparent Volume of Distribution (Vz/F) of Romidepsin in Phase 1|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||Liters||Geometric Coefficient of Variation|Geometric Mean
40025|NCT01456039|Secondary|Apparent Total Clearance of Romidepsin (CL/F) of Romidepsin in Phase 1|The apparent total clearance of romidepsin after a single dose on Day 1, calculated as dose/AUC0-infinity.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||L/h||Geometric Coefficient of Variation|Geometric Mean
40026|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1|The terminal phase half-life of romidepsin after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Geometric Coefficient of Variation|Geometric Mean
40027|NCT01456039|Secondary|Time to Maximum Plasma Concentration of Romidepsin (Tmax) in Phase 1|The time to first maximum observed plasma concentration of romidepsin after a single dose on Day 1.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||hours||Full Range|Median
40028|NCT01456039|Secondary|Maximum Plasma Concentration (Cmax) of Romidepsin in Phase 1|The maximum observed plasma concentration of romidepsin (Cmax) obtained directly from the observed concentration versus time data|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|Pharmacokinetic (PK) Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
40029|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC∞) of romidepsin on Day 1; if possible the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population consisted of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for romidepsin for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
40030|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
40031|NCT01456039|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.|Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks|Safety population includes all participants who received at least one dose of romidepsin||participants|||Number
40032|NCT01456039|Primary|Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2|Objective disease response in PTCL was defined as patients with a complete response (CR), unconfirmed complete response (CRu) or a partial response (PR) according to modified IWC 1999 criteria and assessed by an independent efficacy reviewer. A CR is >75% decrease in size of maximum 6 largest target within nodal and extranodal lesions, complete disappearance of other nodal and extranodal; total disappearance of clinical disease; disease-related signs and symptoms, normalization of biochemical abnormalities, disappearance of spleen, liver, or kidney enlargement; no bone marrow (BM) involvement, no new sites of disease. CRu: all above criteria fulfilled except for BM involvement is indeterminate. PR: a ≥50% decrease in size of 6 largest target lesions and no increase other nodal and extranodal; no progression of clinical disease; disease-related signs and symptoms, normalization or biochemical abnormalities, no progression in size of liver, spleen, or kidney; and no new sites of disease|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of Romidepsin||percentage of participants||95% Confidence Interval|Number
40045|NCT01455545|Secondary|Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion).~Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks|The same as primary outcome.||units on a scale (parts per billion)||Inter-Quartile Range|Median
40149|NCT01454791|Secondary|Subject Global Impression at 2 Weeks|"This is a single question: How would you rate your level of comfort with Copaxone injection during the past two weeks? Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad."|2 weeks|The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint||Likert scale 1-7 (7= best)||Standard Deviation|Mean
40033|NCT01456039|Primary|Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC)|DLT was defined as an adverse event (AE) occurring in Cycle 1 in Phase 1 and judged that the causal relationship to the investigational product could not be denied. The severity of all AEs was graded based upon the NCI CTCAE version 3.0. DLTs were defined as: • Grade 4 Hemoglobin <6.5 g/dL • Grade 4 Neutrophil <500/μL continuing for at least 5 days • Febrile neutropenia (Grade 4 neutropenia caused by fever and ≥ 38.5° C for more than 1 hour) • Grade 4 thrombocyte (< 25,000/μL), or thrombocytopenia with hemorrhage requiring platelet transfusion • Nausea, vomiting, or diarrhea at > grade 3 in spite of treatment • Grade 3 ALT (alanine aminotransferase) or AST (aspartate aminotransferase) values continued for 7 days. • Grade 4 ALT or AST • Grade 2 arrhythmia • Grade 4 non-hematological AEs • Other grade 3 non-hematological AEs except transient fatigue, anorexia, hyponatremia, and tumor lysis syndrome • Other AEs leading to discontinuation of administration|Up to Day 28; Cycle 1|DLT population included all participants in the Phase 1 portion who received at least one dose of romidepsin. Of 8 participants enrolled in the 14mg/m^2 cohort, 2 participants, one with a critical Good Clinical Practice (GCP)violation and the other who did not complete Cycle 1 due to consent withdrawal, were excluded from the DLT assessment.||participants|||Number
40034|NCT01456000|Primary|Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description|Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.|1 year|||Successful Participants|||Number
40035|NCT01455545|Secondary|Asthma Severity According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA).~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months|||participants|||Number
40036|NCT01455545|Secondary|Pulmonary Function Test (Spirometry) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry).~Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months|||percentage of the theoretical||Standard Deviation|Mean
40037|NCT01455545|Primary|Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.|"Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks|||participants|||Number
40038|NCT01455545|Secondary|Concomitant Psychiatric Disorders According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders.~Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks|||participants|||Number
40039|NCT01455545|Secondary|Gastroesophageal Reflux According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux.~Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks|||participants|||Number
40040|NCT01455545|Secondary|Sinusitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.~Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group."|4 weeks|||participants|||Number
40041|NCT01455545|Secondary|Rhinitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis.~Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.~Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline."|4 weeks|||participants|||Number
40042|NCT01455545|Secondary|Obesity According to Level of Asthma Control.|"Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI > 30 obesity.~Asthma control was measured by Asthma Control test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19 ."|4 weeks|||participants|||Number
40043|NCT01455545|Secondary|Smoking Habit According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit.~Good control if ACT score > 19. Bad control if ACT score < or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked."|4 weeks|||participants|||Number
40044|NCT01455545|Secondary|Gender According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender.~Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19."|4 weeks|||participants|||Number
40046|NCT01455545|Primary|Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.|"The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence.~Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma.~To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers)."|4 weeks|||units on a scale||Inter-Quartile Range|Median
40047|NCT01455519|Secondary|Change in NRS After Box Lift|Numeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
40048|NCT01455519|Secondary|Change in NRS After Sit to Stand Repetitions|Numeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
40049|NCT01455519|Secondary|Change in NRS After Treadmill Walk|Numeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
40050|NCT01455519|Secondary|Change in NRS After Stair Climb|Numeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||NRS pain score||Standard Error|Mean
40051|NCT01455519|Secondary|Change in Time to Lift Box|Time to lift 13 pound box to floor and back up to table.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||seconds per lift||Standard Error|Mean
40052|NCT01455519|Secondary|Change in Distance to Floor|Distance from fingers to Floor when bending forward. A functional test of flexibility|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||centimeters||Standard Error|Mean
40053|NCT01455519|Secondary|Change in Sit to Stand Repetitions|Sit to stand repetitions completed in 1 minute|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||number of repetitions||Standard Error|Mean
40054|NCT01455519|Secondary|Change in Treadmill Distance Walked|Treadmill distance walked in 6 minutes|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||miles||Standard Error|Mean
40055|NCT01455519|Secondary|Change in Stair Climb Time|Time to climb 1 flight of stairs|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||seconds||Standard Error|Mean
40056|NCT01455519|Secondary|Change in Pain Disability|The Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
40057|NCT01455519|Secondary|Change in PASS|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
40058|NCT01455519|Primary|Change in VAS|Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
40059|NCT01455519|Primary|Change in McGill Pain Questionnaire – Short Form|The McGill Pain Questionnaire – Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention|||units on a scale||Standard Error|Mean
40060|NCT01455428|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40061|NCT01455428|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40062|NCT01455428|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Deviation|Mean
40063|NCT01455428|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant’s perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40064|NCT01455428|Secondary|Clinical Global Impression of Change (CGIC) Score at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician’s perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40065|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40066|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40067|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40068|NCT01455428|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (consisted of all participants randomized to treatment that received at least 1 dose of study medication) with available data to contribute to the analysis.||percentage of participants|||Number
40069|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40079|NCT01455428|Secondary|Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
40070|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40071|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40072|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
40073|NCT01455428|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure.||units on a scale||Standard Deviation|Mean
40074|NCT01455428|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
40075|NCT01455428|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
40076|NCT01455428|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108||units on a scale||Standard Deviation|Mean
40077|NCT01455428|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8|SF-MPQ was assessed according to the participant’s answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 3, 5, and 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point.||units on a scale||Standard Deviation|Mean
40078|NCT01455428|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|The DPRS consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.|End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||percentage of participants|||Number
40080|NCT01455428|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
40081|NCT01455428|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Deviation|Mean
40082|NCT01455428|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8|The DPRS consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
40083|NCT01455428|Primary|Change From Baseline in Mean Pain Score at Endpoint|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Error|Least Squares Mean
40084|NCT01455428|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Deviation|Mean
40085|NCT01455415|Secondary|PGIC Score at the End of Period 1 (Week 6) - Categorized Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (7 different scores) and categorized scores (4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.||percentage of participants|||Number
40086|NCT01455415|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40087|NCT01455415|Secondary|Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.||percentage of participants|||Number
40108|NCT01455194|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
40088|NCT01455415|Secondary|EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 – but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40089|NCT01455415|Secondary|EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 – but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40090|NCT01455415|Secondary|EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40091|NCT01455415|Secondary|EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40092|NCT01455415|Secondary|EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40093|NCT01455415|Secondary|EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40094|NCT01455415|Secondary|Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale (no problems, some/moderate problems, extreme problems) and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40124|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Oral Calcium at Each Visit||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.||percentage of change||Standard Deviation|Mean
40125|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit||24 Weeks|||percentage of change||Standard Deviation|Mean
40095|NCT01455415|Secondary|Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). The autonomic domain score should be summed as follow: Σ (19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 12). The QOL-DN version that was administered in this study was modified with a 2-week recall period.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40096|NCT01455415|Secondary|Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The small fiber domain score should be summed as follow: Σ (10, 16, 17, 18). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of the listed questionnaire items (range: 0 - 16). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40097|NCT01455415|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. With exception of questions 31 and 32, items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, middle item, is scored as 0, “very good” as -1 , “excellent” as -2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. Physical functioning / large fiber domain score should be summed as follow: Σ (8, 11, 13 - 15, 24, 27 - 35). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: -4 - 56). QOL-DN version that was administered in the study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40098|NCT01455415|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). Activities of the daily living domain score should be summed as follow: Σ (12, 22, 23, 25, 26). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: 0 - 20). The QOL-DN version that was administered in the study was modified with a 2-week recall period.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40099|NCT01455415|Secondary|Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. Item 9 is scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The symptoms domain score should be summed as follow: Σ (1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 32). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40100|NCT01455415|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as -1, “excellent” as -2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The (sub)scales are calculated without weighting of any kind, and reported as the integer sum of listed questionnaire items (range: -4 - 136). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40150|NCT01454791|Primary|Pain Scale at 2 Weeks|0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint||units on a scale||Standard Deviation|Mean
40101|NCT01455415|Secondary|HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|HADS is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40102|NCT01455415|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40103|NCT01455415|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates “does not interfere with sleep” and 10 indicates “completely interferes (unable to sleep due to pain)”. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40104|NCT01455415|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Seven sub-questions evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on an 11-point scale (0: does not interfere; 10: completely interferes). Scores range from 0 - 10 with higher scores indicating greater interference.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40105|NCT01455415|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Four items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 10 with higher scores indicating greater pain severity.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||units on a scale||Standard Error|Least Squares Mean
40106|NCT01455415|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||percentage of participants|||Number
40107|NCT01455415|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.||percentage of participants|||Number
40126|NCT01455181|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks|||percentage of participants||95% Confidence Interval|Number
40109|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
40110|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP >170 millimeters of mercury (mm Hg) or <85 mm Hg, Diastolic BP >105 mm Hg, resting pulse rate: >120 bpm or <50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment >40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment >30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
40111|NCT01455194|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
40112|NCT01455194|Secondary|Number of Participants With Markedly High Benefits|The analyses was intended to identify participant’s subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included.|Week 1 up to Week 52|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.||participants|||Number
40113|NCT01455194|Secondary|Number of Participants Reporting Asthma Exacerbations Rates|Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
40114|NCT01455194|Secondary|Number of Participants Reporting Time to First Asthma Exacerbation|Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
40115|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point|Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
40127|NCT01455064|Primary|Clarke Error Grid Analysis|Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.|15 days sensor wear|One subject was withdrawn due to a mild reaction to the sensor adhesive. This subject's data was included in the study up to the point of withdrawal.||Percentage of Results|Participants||Number
40116|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
40117|NCT01455194|Secondary|Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||participants|||Number
40118|NCT01455194|Secondary|Number of Weeks With Well-controlled Asthma Over the Course of the Study|The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||weeks|weeks||Number
40119|NCT01455194|Secondary|Time Course of ACQ|The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline, Week 52 (Treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||Weeks||Full Range|Median
40120|NCT01455194|Primary|Change From Baseline in ACQ Score to Tlast|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||units on a scale||Standard Error|Mean
40121|NCT01455194|Primary|Asthma Control Questionnaire (ACQ) Score at Baseline|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline|The intent-to-treat (ITT) analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.||units on a scale||Standard Error|Mean
40122|NCT01455181|Secondary|Mean Change From Baseline in 24-hour Urine Calcium Excretion||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.||mg/24 hour||Standard Deviation|Mean
40123|NCT01455181|Secondary|Proportion of Patients Achieving the Primary Endpoint at Each Visit|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement .||percentage of participants|||Number
40128|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 6 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 6 measures subject's tiredness or sleepiness during the day on a 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40129|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 5 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 5 measures the severity of RLS during day not rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 5 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40130|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 4 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 4 measures the severity of RLS during day rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 4 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40131|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 3 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 3 measures the severity of RLS during the night on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 3 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40132|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 2 measures the severity of RLS at time falling asleep on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 2 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40133|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 1 measures subject's satisfaction with sleep on a 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40134|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period|"The CGI Item 3 score measures the therapeutic efficacy on a 4-point scale consisting of the following categories:~1- Very good~2- Moderate~3- Slight~4- Unchanged or worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||participants|||Number
40135|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period|"The CGI Item 1 score measures the severity of illness on a 7-point scale consisting of the following categories:~1- Normal, not ill at all~2- Borderline ill~3- Mildly ill~4- Moderately ill~5- Markedly ill~6- Severely ill~7- Among the most extremely ill subjects"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||participants|||Number
40136|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period|"The CGI Item 2 score measures any change in severity of RLS from Baseline on a 7-point scale consisting of the following categories:~1- Very much improved~2- Much improved~3- Minimally improved~4- No change~5- Minimally worse~6- Much worse~7- Very much worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||participants|||Number
40148|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 week|||hours/night||Standard Deviation|Mean
40137|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period|The RLS-QoL is a disease-specific instrument for the evaluation of Quality of life. It consists of 12 items and the overall sum score is calculated from all 12 items and measured on a scale that ranges from 0 (lowest Quality of life) to 60 (highest level of Quality of life). A negative value in RLS-QoL Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40138|NCT01455012|Secondary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period|The IRLS is a subject-based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' daytime functioning. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items was calculated. A negative value in IRLS Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||units on a scale||Standard Deviation|Mean
40139|NCT01455012|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in PLMI Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||Periodic Limb Movements/hour||Standard Deviation|Mean
40140|NCT01455012|Secondary|Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.~A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||Nocturnal Elevations of Systolic BP||Standard Deviation|Mean
40141|NCT01455012|Primary|Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.~A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.||Nocturnal Elevations of Systolic BP||95% Confidence Interval|Least Squares Mean
40142|NCT01454830|Secondary|Acceptability of Study Intervention and Comparative Group|"Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to interview at study termination and debriefing (3 months)"|3 months|"Acceptability rating by participants allocated to interview at study termination and debriefing; self-reported rating for binary response to satisfaction with study experience (yes/no); reported as percentage responding yes; no data available for participants who withdrew or were excluded prior to 3-month visit."||"percentage of allocated responding yes"|||Number
40143|NCT01454830|Secondary|Proportion of Participants Who Withdrawal|Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals requested from study||percentage of participants|||Number
40144|NCT01454830|Secondary|Proportion of Participants Who Complete Protocol After Allocation|Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals, administrative withdrawals for incomplete protocol procedures due to attrition; does NOT include excluded by a priori determined exclusion criteria for protocol||percentage of participants|||Number
40145|NCT01454830|Secondary|Proportion of Sleep Time on CPAP|% of Total Sleep Time (TST) using CPAP|1 week|Randomized participants with complete primary outcome data and secondary outcome data (total sleep time) measured by concurrent wrist actigraphy during first week of PAP treatment||percentage of TST on PAP||Standard Deviation|Mean
40146|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|3 months|||hours/night||Standard Deviation|Mean
40147|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 month|||hours/night||Standard Deviation|Mean
40151|NCT01454791|Primary|Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks|patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint||units on a scale||Standard Deviation|Mean
40152|NCT01454778|Primary|Rutherford Classification of Peripheral Arterial Disease|"Evidence of stenosis of lower extremity as measured by the Rutherford Classification post revascularization. The ABI and Rutherford Classification will be assessed at 10 months post revascularization with a lower Rutherford score indicating a better outcome.~0 = Asymptomatic, 1 = Mild Claudication, 2 = Moderate Claudication, 3 = Severe Claudication, 4 = Ischemic Rest Pain, 5 = Minor Tissue Loss, 6 = Ulceration or Gangrene"|10 months|||units on a scale||Standard Deviation|Mean
40153|NCT01454778|Secondary|Number of Serious Adverse Events||Up to 19 months|||Number of SAE's|||Number
40154|NCT01454778|Secondary|Freedom From Binary Restenosis||10 months|||percentage of participants|||Number
40155|NCT01454778|Secondary|Freedom From Target Vessel Revascularization Event||up to 10 months|||percentage of participants|||Number
40156|NCT01454778|Secondary|Freedom From Amputation Event||up to 10 months|||percentage of participants|||Number
40157|NCT01454778|Primary|Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months|The Ankle-Brachial Index is calculated as a ratio of the ankle blood pressure and the arm blood pressure. The ABI and Rutherford Classification will be assessed at 10 months post revascularization|10 months|||ratio||Standard Deviation|Mean
40158|NCT01454726|Primary|Change in Dizziness Handicap Inventory (DHI) Questionnaire Score|dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0.|0 and 24 hours|Among the 27 participants enrolled in the study, one participant quitted the study before treatment application. Twenty-six patients fulfilled all the procedures and were eligible for the full analysis.||units on a scale||Standard Deviation|Mean
40159|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|3 years follow up|||percentage of patients|||Number
40160|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|2 years follow up|||percentage of patients|||Number
40161|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|1 year follow up|||percentage of patients|||Number
40162|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 3 years|||percent change||Standard Deviation|Mean
40163|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 3 years|||percent change||Standard Deviation|Mean
40164|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years|||percent change||Standard Deviation|Mean
40165|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years|Patients with DM or HF and RR measurement at baseline and 3 years follow-up||percent change||Standard Deviation|Mean
40166|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years|||percent change||Standard Deviation|Mean
40167|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years|Patients with RR measurement at baseline and 2 years follow-up||percent change||Standard Deviation|Mean
40168|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 1 year|||percent change||Standard Deviation|Mean
40169|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 2 years|||percent change||Standard Deviation|Mean
40251|NCT01453374|Secondary|Opioid Use|Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.|7 months|All subjects with non-missing data who had at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants with positive opioid use|||Number
40170|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 2 years|||percent change||Standard Deviation|Mean
40171|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 1 year|||percent change||Standard Deviation|Mean
40172|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 1 year|||percent change||Standard Deviation|Mean
40173|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the three years of observation period|3 years follow up|||percentage of patients|||Number
40174|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first two years of observation period|2 years follow up|||percentage of patients|||Number
40175|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first year of observation period|1 year follow up|||percentage of patients|||Number
40176|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 3 years|||percentage of patients|||Number
40177|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 2 years|||percentage of patients|||Number
40178|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 1 year|||percentage of patients|||Number
40179|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100|baseline and 1 year|||percent change||Standard Deviation|Mean
40180|NCT01454531|Secondary|Change in Immediate Cutaneous Response to Phleum Pratense|Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1|baseline (visit 1) and at 6 weeks (visit 6)|Participants in which results of the Parallel Line Assay are valid||CTI, Cutaneous Tolerance Index||95% Confidence Interval|Mean
40181|NCT01454531|Secondary|Change in Phleum Pratense Specific IgG4||baseline (visit 1) and at 6 weeks (visit 6)|Number of subject with valid data in visit 1 and visit 6||mgA/l||Standard Deviation|Mean
40182|NCT01454531|Secondary|Change in Phleum Pratense Specific IgE-blocking Factor|"IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of:~IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure"|baseline (visit 1) and at 6 weeks (visit 6)|||arbitrary units||Standard Deviation|Mean
40183|NCT01454531|Secondary|Frequency of Subjects With Local Adverse Reaction|Frequency of patients with local adverse reactions|6 weeks|||participants|||Number
40184|NCT01454531|Secondary|Frequency of Subjects With Systemic Reactions|Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)|6 weeks|||participants|||Number
40185|NCT01454531|Primary|Frequency of Subjects With Adverse Drug Reactions|Frequency of patients with adverse reactions, local or systemic|6 weeks|Subjects treated||participants|||Number
40186|NCT01454505|Primary|Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.||Units on a scale||Standard Deviation|Mean
40187|NCT01454505|Secondary|Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.||Units on a scale||Standard Deviation|Mean
40188|NCT01454505|Primary|Number of Adverse Events in Stage A|Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.|Day 1|This reporting group includes all subjects exposed to test article during Stage A.||Adverse Events|||Number
40189|NCT01454414|Secondary|Seroconversion Against a Tick-borne Illness|We will define seroconversion as one in which there is a 4-fold change in Immunoglobulin G class antibody titer between sera at enrollment, sera obtained after one year and/or sera obtained at study's end or between acute and convalescent sera for participants developing an acute illness. The antigens that will be used in the serologic assays include Ehrlichia chaffeensis (which would also detect antibodies to E. ewingii and Anaplasma phagocytophilum) and Rickettsia rickettsii (which would also detect antibodies to other spotted fever group rickettsiae).|Upon enrollment, after the first year, and after the second year||||||
40190|NCT01454414|Primary|Work Related Tick Bites|Tick bites are defined as ticks attached to or embedded in the skin|Weekly for two years|||tick bites|||Number
40191|NCT01454401|Primary|Ulcer Healing Within 20 Weeks|Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.|20 weeks|Number of the patients achieved complete epithelialisation at 20 weeks in the ITT population and in the PP population||participants|||Number
40192|NCT01454401|Secondary|Ulcer Healing Within 12 Weeks.|Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population|12 weeks|Complete epithelialisation was achieved in 15 patients (34%) in ITT population and 38% in the PP population||participants|||Number
40193|NCT01454258|Primary|Number of Different Substitution Solutions Administered||24h|Surgical patients from 10 hospitals over a period of 13 months||participants|||Number
40194|NCT01454063|Secondary|Ocular Pain VAS Score After Day of Surgery - Day 1|Pain VAS scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time-point.|One day|Number of subjects with scores at time point.||units on a scale||Standard Deviation|Mean
40195|NCT01454063|Secondary|Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1|"The mean SOIS summarized by treatment arm and time point on Day 1 postoperatively. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with score at time point.||units on a scale||Standard Deviation|Mean
40196|NCT01454063|Secondary|Best Corrected Visual Acuity (BVCA) Log Score on Day 1|Best-Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day|Subject who could read well enough to obtain visual acuity score.||Log score||Standard Deviation|Mean
40197|NCT01454063|Secondary|Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at Day 1 postoperatively|One day|Subjects with scores at time point.||participants|||Number
40198|NCT01454063|Secondary|Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at 6 hours postoperatively.|Six hours postoperatively|Subjects with scores at time point.||participants|||Number
40199|NCT01454063|Secondary|Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively|The primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) was based on the mean area-under-the-curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hours. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours|Subjects with scores at time points.||units on a scale||Standard Deviation|Mean
40200|NCT01454063|Primary|Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery|"Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute).~The primary analysis of the change in pupil diameter was based on the mean area-under-the-curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC."|from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.||mm||Standard Deviation|Mean
40201|NCT01453998|Primary|Concentrations for Anti-Pertussis Toxoid.||One month after the booster dose||12/2020||||
40202|NCT01453998|Primary|Concentrations for Anti-poliovirus Types 1, 2 and 3||One month after the booster dose||12/2020||||
40203|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-Pertussis Toxoid.||One month after the booster dose||12/2020||||
40204|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3.||One month after the booster dose||12/2020||||
40205|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40206|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40207|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40208|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40209|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40210|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40211|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40212|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.||Subjects|||Number
40213|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
40214|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
40215|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
40216|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
40217|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
40218|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
40219|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||IU/mL||95% Confidence Interval|Geometric Mean
40220|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
40221|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||µg /mL||95% Confidence Interval|Geometric Mean
40222|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
40223|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||IU/mL||95% Confidence Interval|Geometric Mean
40224|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.||Subjects|||Number
40225|NCT01453946|Primary|Adverse Event|Any kind of adverse event|16 weeks|Safety analysis set||Subjects|||Number
40226|NCT01453946|Secondary|IMPACT 3|IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE|12 weeks|Safety analysis set||Score units||Standard Deviation|Mean
40227|NCT01453946|Secondary|PCDAI|Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)|12 weeks|Full Analysis Set||Scores on a scale||Standard Deviation|Mean
40228|NCT01453894|Primary|Completion of a Fecal Occult Blood Test (FOBT)|This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.|within 6 months of randomization|||participants|||Number
40229|NCT01453855|Primary|Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)|As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)|The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
40230|NCT01453725|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.|Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2|The APaT population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.||Percentage of Participants|||Number
40231|NCT01453725|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.|Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)|The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.||Percentage of Participants|||Number
40232|NCT01453725|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16|Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1, who completed Part 1, and who had Baseline and Week 16 MRI SI joint measurements.||Score on a Scale||Standard Deviation|Mean
40233|NCT01453725|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Week 16|ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.||Percentage of Participants|||Number
40234|NCT01453725|Secondary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16|The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1 and had a Baseline BASDAI assessement.||Percentage of Participants|||Number
40235|NCT01453725|Secondary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.||Percentage of Participants|||Number
40236|NCT01453725|Primary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.|Week 16|The Full-Analysis-Set (FAS) population consisted of all randomized participants who received at least one dose of study drug in Part 1.||Percentage of Participants|||Number
40237|NCT01453595|Primary|Objective Response Rate (ORR)|In patients with advanced clear cell RCC, progressing after prior first-line or second-line mTOR therapy. The determination of antitumor efficacy will be based on objective tumor assessments made according to the RECIST1.1.|1 year|ORR was only assessed for participants who completed the study, which were only 5 patients on Cohort -1||participants|||Number
40252|NCT01453374|Secondary|Incidence of Subject Re-incarceration|Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants re-incarcerated|||Number
40253|NCT01453374|Primary|Incidence of Subject Re-arrest|Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants re-arrested|||Number
40238|NCT01453569|Secondary|Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.||units on a scale||Standard Error|Mean
40239|NCT01453569|Secondary|Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.||units on a scale||Standard Error|Mean
40240|NCT01453569|Secondary|Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse.|24 weeks|||participants|||Number
40241|NCT01453569|Primary|Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.||units on a scale||Standard Error|Mean
40242|NCT01453413|Secondary|Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)||percentage of subjects||95% Confidence Interval|Number
40243|NCT01453413|Primary|Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)||percentage of subjects||95% Confidence Interval|Number
40244|NCT01453374|Secondary|Criminal Activity|Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants with criminal activity|||Number
40245|NCT01453374|Secondary|Cocaine Use|Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL||participants who used cocaine|||Number
40246|NCT01453374|Secondary|Opioid Dependence|Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence|7 months||||||
40247|NCT01453374|Secondary|Opioid Craving|Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.|8 months|All subjects with non-missing data who received at least 1 injection of VIVITROL||units on a scale||Standard Deviation|Mean
40248|NCT01453374|Secondary|Retention in the Community|Number of subjects who received all 6 post-release VIVITROL injections|6 months|All subjects who received at least 1 injection of VIVITROL||participants received all 7 injections|||Number
40249|NCT01453374|Secondary|Drug Abuse Treatment Program Entry|Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data||participants who entered drug treatment|||Number
40250|NCT01453374|Secondary|Opioid Overdose|"Number of subjects who overdosed during the study; measured through reported AEs of overdose and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times."|7 months|All subjects who received at least 1 injection of VIVITROL||participants who overdosed|||Number
40254|NCT01453348|Secondary|Percentages of Subjects With Unsolicited Adverse Events (AEs)|Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).|Day 1 to day 57.|Analysis was done on safety set- subjects who provided any post-baseline safety data.||percentage of subjects|||Number
40255|NCT01453348|Secondary|hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29|Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.|28 days post vaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.||Titers||95% Confidence Interval|Geometric Mean
40256|NCT01453348|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29|"Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.~For a subject with a baseline hSBA titer < 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days postvaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.||percentage of subjects||95% Confidence Interval|Number
40257|NCT01453348|Secondary|Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination|Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination.|28 days post primary or booster vaccination.|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.||percentage of subjects||95% Confidence Interval|Number
40258|NCT01453348|Primary|Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination|Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.|Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.|Analysis was done on Per Protocol (PP) population who provided evaluable serum samples and whose assay results were available at the relevant time points, and had no major protocol deviations||Concentrations (mIU/mL)||95% Confidence Interval|Geometric Mean
40259|NCT01453296|Primary|Weighted Mean QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia’s formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds||Standard Error|Least Squares Mean
40260|NCT01453296|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 1 and Day 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed.||micrograms||Standard Deviation|Mean
40261|NCT01453296|Secondary|Total Emitted Dose (TED) on Day 1 and Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.||micrograms||Standard Deviation|Mean
40282|NCT01453296|Primary|Mean Corpuscle Hemoglobin (MCH) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^12 picograms (pg) per cell||Standard Deviation|Mean
40262|NCT01453296|Secondary|Peak Pressure Drop on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilopascal (kpa)||Standard Deviation|Mean
40263|NCT01453296|Secondary|Inhaled Volume on Day 1 and Day 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg."|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
40264|NCT01453296|Secondary|Inhalation Time on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Seconds (sec)||Standard Deviation|Mean
40265|NCT01453296|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
40266|NCT01453296|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (centimeters cubed [cm^3]) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||cm^3||Standard Deviation|Mean
40267|NCT01453296|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters (cm)||Standard Deviation|Mean
40268|NCT01453296|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters squared (cm^2)||Standard Deviation|Mean
40269|NCT01453296|Secondary|Blood Glucose and Potassium on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. . Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
40270|NCT01453296|Secondary|Tmax, t1/2, and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, t1/2 is defined as the time required to reduce the plasma concentration to one half its initial value, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
40271|NCT01453296|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
40272|NCT01453296|Secondary|AUC(0-t) and AUC(0-8) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 8 hours AUC(0-8) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 14 of the respective treatment period (up to Study Day 49)|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzee. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
40273|NCT01453296|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia’s formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds||Standard Error|Least Squares Mean
40283|NCT01453296|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
40298|NCT01453049|Secondary|Change From Baseline in Heart Rate at Week 24/EW|The heart rate of the participants was measured. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||beats per minute (bpm)||Standard Deviation|Mean
40274|NCT01453296|Primary|Weighted Mean Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Error|Least Squares Mean
40275|NCT01453296|Primary|Maximum Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Error|Least Squares Mean
40276|NCT01453296|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, Day 8, and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1, Day 8, and Day 14 of the respective treatment period. PD=post-dose. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
40277|NCT01453296|Primary|Peak Expiratory Flow on Day 1, Day 8, and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||liters/minute||Standard Deviation|Mean
40278|NCT01453296|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
40279|NCT01453296|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
40280|NCT01453296|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
40281|NCT01453296|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
40467|NCT01451398|Secondary|Time to Rescue|Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment|Baseline to Week 24|Full analysis set||Days||Full Range|Median
40284|NCT01453296|Primary|Hematocrit Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.||proportion of 1||Standard Deviation|Mean
40285|NCT01453296|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
40286|NCT01453296|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
40287|NCT01453296|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
40288|NCT01453296|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 8)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
40289|NCT01453166|Secondary|Blood Glucose|Change From Baseline in blood glucose|12 weeks|Participants who were evaluable at this time point were analyzed||mg/dl||Standard Error|Mean
40290|NCT01453166|Secondary|Waist Circumference|Change From Baseline in wais circumference|12 weeks|Participants who were evaluable at this time point were analyzed||cm||Standard Error|Mean
40291|NCT01453166|Primary|Total Cholesterol|Change From Baseline in total Cholesterol|12 weeks|Participants who were evaluable at this time point were analyzed.||mg/dl||Standard Error|Mean
40292|NCT01453166|Secondary|Weight|Change From Baseline in weight|12 weeks|Participants who were evaluable at this time point were analyzed||kg||Standard Error|Mean
40293|NCT01453166|Primary|Systolic Blood Pressure|Change From Baseline in systolic blood pressure|12 weeks|Participants who were evaluable at this time point were analyzed||mmHg||Standard Error|Mean
40294|NCT01453075|Primary|Effect of HSV-2 Suppression on HCV Viral Load.|Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo|baseline; 12 weeks|Analyzed patients who completed study||log(IU/mL)||Standard Error|Mean
40295|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW|PR, QT, QTc, RR, QRS, and QRS axis data were measured by ECG. The PR interval (int.) starts at the beginning of the atrial contraction and ends at the beginning of the ventricular contraction. QT (QT int.) and QTc (corrected QT int.) indicate how fast the ventricles are repolarized, becoming ready for a new cycle. The RR int. represents the duration of the ventricular cardiac cycle and is an indicator of ventricular rate. QRS (QRS duration) indicates how fast the ventricles depolarize. The QRS axis is an indicator of the electrical heart axis, which is an average of all heart depolarization.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||milliseconds (msec)||Standard Deviation|Mean
40296|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Assessment of Heart Rate at Week 24/EW|Electrocardiograms of the participants were taken for the evaluation of heart rate. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||bpm||Standard Deviation|Mean
40297|NCT01453049|Secondary|Change From Baseline in Weight at Week 24/EW|The weight of the participants was measured. Change from Baseline in weight was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||kilograms (kg)||Standard Deviation|Mean
40468|NCT01451398|Secondary|Proportion of Subjects Requiring Rescue Therapy||Baseline to Week 24|Full analysis set||percentage of participants|||Number
40299|NCT01453049|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24/EW|The blood pressure of the participants was measured. Change from Baseline in SBP and DBP was calculated as the value at Weeks 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
40300|NCT01453049|Secondary|Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW|Blood samples of participants were collected for TB, DB, creatinine, and UC assessment. Change from Baseline in TB, DB, creatinine, and UC was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Micromoles per liter (mcmol/L)||Standard Deviation|Mean
40301|NCT01453049|Secondary|Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW|Blood samples of participants were collected for ALT, AST, GGT, LDH, ALP, and CK assessment. Change from Baseline in ALT, AST, GGT, LDH, ALP, and CK was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Units per liter (U/L)||Standard Deviation|Mean
40302|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Week 24/EW|Blood samples of participants were collected for MCH assessment. Change from Baseline in MCH was calculated as the value at Week 24/EW minus the value at Baseline. MCH is the average amount of hemoblobin inside a RBC expressed in picograms. MCH is calculated by dividing the hemoglobin concentration in grams per deciliter by the RBC count in millions per microliter, then multiplying by 10. MCH is one of the three main RBC indices which are helpful to determine the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Picograms (pg) per cell||Standard Deviation|Mean
40303|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV) at Week 24/EW|Blood samples of participants were collected for MCV assessment. Change from Baseline in MCV was calculated as the value at Week 24/EW minus the value at Baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the RBC count in millions per microliter of blood, then multiplying by 10. MCV is one of the three main RBC indices that are helpful in determining the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Femtoliters (FL) per cell||Standard Deviation|Mean
40304|NCT01453049|Secondary|Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW|Blood samples of participants were collected for HE, MCHC, and TP assessment. Change from Baseline in HE, MCHC, and TP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Grams per liter (G/L)||Standard Deviation|Mean
40305|NCT01453049|Secondary|Change From Baseline in Hematocrit (HCT) at Week 24/EW|Blood samples of participants were collected for HCT assessment. Change from Baseline in HCT was calculated as the value at Week 24/EW minus the value at Baseline. HCT is measured as the percentage of the volume of whole blood that is made up of red blood cells.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||percentage of volume of whole blood||Standard Deviation|Mean
40306|NCT01453049|Secondary|Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW|Blood samples of participants were collected for lymphocyte, monocyte, neutrophil, eosinophil, and basophil assessment. Change from Baseline in lymphocytes, monocytes, neutrophils, eosinophils, and basophils was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||percent of WBC count||Standard Deviation|Mean
40307|NCT01453049|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 24/EW|Blood samples of participants were collected for RBC count assessment. Change from Baseline in RBC count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Pico per liter (10^12/ L) cells||Standard Deviation|Mean
40308|NCT01453049|Secondary|Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW|Blood samples of participants were collected for WBC count and platelet count assessment. Change from Baseline in WBC count and platelet count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Giga per liter (10^9/L) cells||Standard Deviation|Mean
40309|NCT01453049|Secondary|Number of Participants With a Bone Fracture|Participants with a break in the continuity (fracture) of the bone were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
40310|NCT01453049|Secondary|Number of Hypoglycemic Events|A hypoglycemic event is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants, participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Hypoglycemic events|||Number
40311|NCT01453049|Secondary|Number of Participants With Hypoglycemic Events|Blood samples of participants were collected for the assessment of blood glucose levels. Hypoglycemia is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants; participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
47728|NCT01350232|Secondary|Cytokine Profile|To characterize the profiles of cytokines released following administration of the lymphoid portion of the transplant (donor lymphocyte infusion [DLI]).|Through 5 years after infusion||||||
40312|NCT01453049|Secondary|Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW|In diabetic participants, QOL, anxiety, and depression were measured by the A-DQOL scale . There are 46 core items (10 additional items for adolescents) and 4 major dimensions: treatment satisfaction, treatment impact, worry about long-term complications, and worry about social/vocational issues. Participants respond to all items on a 5-point Likert scale: 1, no impact, no worries, or always satisfied; 5, always affected, always worried, or never satisfied. The total score is a sum of the individual scores of all 46 items (range of 46 to 230); a lower score indicates a better QOL.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
40313|NCT01453049|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW|EQ-5D is used as a measure of health outcome and includes single-item measures (coded on a 3-point scale [1, no problems; 2, some problems; 3, severe problems]) of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument includes a global rating of current health using a visual analog scale (VAS): 0 (worst imaginable) to 100 (best imaginable). Health states may be converted to a single summary index by applying a formula that attaches values to each of the levels in each dimension. The index scale is -0.111 to 1. A lower index indicates worse health.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
40314|NCT01453049|Secondary|Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Percent change from Baseline in hs-CRP was calculated as the value at Visit 8 (Wk 24)/ EW minus the value at Baseline divided by value at Wk 24/ EW multiplied by 100.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||percent change||Full Range|Median
40315|NCT01453049|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Change from Baseline in hs-CRP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||mmol/L||Standard Deviation|Mean
40316|NCT01453049|Secondary|Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C and LDL-C) assessment. The ratio of TC/HDL-C and LDL-C/HDL-C was calculated. Change from Baseline in the ratio of TC/HDL-C and LDL-C/HDL-C was calculated as the value at Week 24/EW minus the value at Baseline. For TC/HDL-C, the numerator is TC, and the denominator is HDL-C. For LDL-C/HDL-C, the numerator is LDL-C, and the denominator is HDL-C.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||ratio||Standard Deviation|Mean
40317|NCT01453049|Secondary|Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW|Blood samples of participants were collected for BUN and electrolyte (sodium, potassium, chloride, calcium, and phosphorus) assessment. The electrolyte balance asseses the condition of the heart and the kidneys, and BUN assesses the condition of the kidneys. Change from Baseline in BUN, sodium, potassium, chloride, calcium, and phosphorus was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population: all participants who received at least one dose of study medication. Only those participants contributing data at the indicated time points were analyzed.||mmol/L||Standard Deviation|Mean
40318|NCT01453049|Secondary|Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C, LDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Change from Baseline in TC, HDL-C, LDL-C, and TG was calculated as the value at Week 24)/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||mmol/L||Standard Deviation|Mean
40319|NCT01453049|Secondary|Number of Participants at Various Dose Levels at Week 24/EW|The number of participants at the different dose levels at Week 24/EW was recorded. The different dose levels for Rosi + Glim are: Dose level 1, Rosi 4 mg + Glim 1 mg; Dose level 2, Rosi 4 mg + Glim 2 mg; Dose level 3, Rosi 4 mg + Glim 4 mg. The different dose levels for Glim are: Dose level 1, Glim 1 mg; Dose level 2, Glim 2 mg; Dose level 3, Glim 4 mg.|Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed. Data were missing for one participant in the rosiglitazone+glimepiride FDC arm.||participants|||Number
40320|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-B is calculated using the following mathematical model to predict glucose and insulin concentrations=(20*FI[mU/ml])/(FG[mmol/l]-3.5).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||Ratio: 20*FI (num.); FG-3.5 (denom.)||Standard Deviation|Mean
40321|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW|Blood samples of participants who had fasted for 12-14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-S is calculated using the following model to predict glucose and insulin concentrations=(FI[milliunits (mU)/milliliter (ml)]*FG [millimoles per liter (mmol/l)])/22.5. numerator, num.; denominator, denom.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||Ratio: FI*FG (num.); 22.5 (denom.)||Standard Deviation|Mean
40469|NCT01451398|Secondary|FPG Change From Baseline to Week 24|Efficacy as measured by mean change in fasting plasma glucose (FPG)|Baseline to Week 24|Full analysis set for subjects with data at both Baseline and at Week 24||mg/dL||Standard Error|Least Squares Mean
40322|NCT01453049|Secondary|Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW)|Blood samples of participants who had fasted for 12-14 hours were collected for fasting proinsulin (precursor of insulin) and insulin assessment. Preproinsulin is sequentially processed via proinsulin, through intermediate proteolytic cleavage products, to insulin and C-peptide before release from the beta cell granule by exocytosis. Elevated levels of proinsulin are considered indicative of beta cell dysfunction. Insulin is a hormone that regulates carbohydrate and fat metabolism in the body. Change from Baseline was calculated as the value at Week 24/ EW minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.||Picomoles per liter (pmol/L)||Standard Deviation|Mean
40323|NCT01453049|Secondary|Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline|Blood samples of participants were collected for HbA1c assessment.|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
40324|NCT01453049|Secondary|Number of FPG Responders and Non-responders|Blood samples of participants were collected for FPG assessment. FPG responders are definded as participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG level < 6.1 mmol/L at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
40325|NCT01453049|Secondary|Number of HbA1c Responders and Non-responders|Blood samples of participants were collected for HbA1c assessment. HbA1c responders were defined as participants who had achieved HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
40326|NCT01453049|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood samples of participants were collected for FPG assessment. The FPG test, also known as the fasting blood sugar test, measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FBG was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|FAS. Missing values were imputed using the Last Observation Carried Forward (LOCF) method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
40327|NCT01453049|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|Full Analysis Set (FAS): all randomized participants who received >=1 dose of study medication and had >=1 post-Baseline efficacy assessment. Missing values were imputed using Last Observation Carried Forward (used to estimate subsequent missing data points). Only those participants contributing data at the indicated time points were analyzed.||Percent of total hemoglobin||Standard Deviation|Mean
40328|NCT01453036|Primary|Helicobacter Pylori Eradication Rate|Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.|8 weeks|Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence – 50%, expected dropout rate -15%, predicted eradication rate – 80%, significance level - 0.05, statistical power - 90%||percentage of participants||95% Confidence Interval|Number
40329|NCT01453023|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
40330|NCT01453023|Secondary|Total Emitted Dose (TED) on Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
40470|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 6.5%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24|Week 24|Full analysis set for subjects with available data at Week 24||percentage of participants|||Number
40331|NCT01453023|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilopascal (kpa)||Standard Deviation|Mean
40332|NCT01453023|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
40333|NCT01453023|Secondary|Inhalation Time on Days 1 and 14 of of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Seconds (sec)||Standard Deviation|Mean
40334|NCT01453023|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
40335|NCT01453023|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
40336|NCT01453023|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters (cm)||Standard Deviation|Mean
40354|NCT01453023|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^12 picograms (pg) per cell||Standard Deviation|Mean
47729|NCT01350232|Secondary|Quality of Life|To describe the quality of life and functional status following transplantation.|Through 5 years post infusion||||||
40337|NCT01453023|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day X)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters squared (cm^2)||Standard Deviation|Mean
40338|NCT01453023|Secondary|Serum Cortisol (SC) Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period|"SC weighted mean was determined for each participant over the time period of 0–12 hours on Day 14 of the respective treatment period. SC weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 8, and 12 hours (relative to the 0 time point). Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect."|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||nanomoles per Liter||95% Confidence Interval|Geometric Mean
40339|NCT01453023|Secondary|Blood Glucose and Potassium Values on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
40340|NCT01453023|Secondary|Tmax and Tlast of VI on Day 1 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum VI concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.||hours||Full Range|Median
40341|NCT01453023|Secondary|Cmax of VI on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of VI on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
40342|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of VI on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for VI.||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
40343|NCT01453023|Secondary|Tmax and Tlast of FF on Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.||hours||Full Range|Median
40344|NCT01453023|Secondary|Cmax of FF on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of FF on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
40471|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set for subjects with available data at Week 24||percentage of participants|||Number
40345|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of FF on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|FF Pharmacokinetic (PK) Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for FF.||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
40346|NCT01453023|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|QTcF is the QT domain corrected for heart rate by Fridericia’s formula. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds||Standard Error|Least Squares Mean
40347|NCT01453023|Primary|Change From Baseline in Heart Rate at Day1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Error|Least Squares Mean
40348|NCT01453023|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1 and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
40349|NCT01453023|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||liters/minute||Standard Deviation|Mean
40350|NCT01453023|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
40351|NCT01453023|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
40352|NCT01453023|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
40353|NCT01453023|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
40472|NCT01451398|Primary|Change From Baseline to Week 24 in HbA1c|Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24|Baseline to Week 24|Full analysis set||percentage of hemoglobin||Standard Error|Least Squares Mean
40355|NCT01453023|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
40356|NCT01453023|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.||proportion of 1||Standard Deviation|Mean
40357|NCT01453023|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
40358|NCT01453023|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
40359|NCT01453023|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
40360|NCT01453023|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 9)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
40361|NCT01452854|Primary|Ovarian Aging (AFC and Hormones)|Transvaginal Ultrasound will be use to measure Antral Follicle Counts (AFC) and blood will be drawn to measure hormones (FSH, LH, estradiol, estrone, AMH, SHBG, testosterone, and inhibin B).|Every 3 months for 1 year|Data collection was terminated and analyses were not performed due to low enrollment|||||
40362|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Week 12||||||
40363|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Week 12||||||
40364|NCT01452529|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test."|Week 12||||||
40365|NCT01452529|Secondary|Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)|The scale consists of 12 individual items categorized into a sleep problems index and 6 subscales: 4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 daytime somnolence, 1 snoring, 1 shortness of breath. Scores range from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12||||||
40366|NCT01452529|Primary|"Mean Pain Intensity for Average Pain Over the Last 24 Hours Score"|"Mean pain intensity for average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale||Standard Error|Mean
40367|NCT01452425|Primary|Intracompartmental Pressure (ICP)|[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block|45 minutes|||mmHg||Standard Deviation|Mean
40368|NCT01452425|Primary|Comparison Between INVOS Monitoring and Electromyography|"A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block.~Measures were:~[mean (SD)] INVOS (in %) value at baseline and at the time of the block"|45 minutes|||% of StcO2||Standard Deviation|Mean
40527|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 26||26 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.||copies/ml||Full Range|Median
40369|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12|Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group.|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
40370|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
40371|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
40372|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||percentage of participants|||Number
40373|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
40374|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
40375|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
40376|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
40377|NCT01452269|Primary|Change in Physical Activity Assessment (PAA) Score|We measured the mean change in the moderate PAA scoare for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. PAA moderate activity scores range from 0-27; higher scores are better (more physical activity).|Baseline and 6 months|||moderate PAA score||Standard Error|Mean
40528|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 12||12 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.||copies/ml||Full Range|Median
40378|NCT01452269|Primary|Change in Dietary Risk Assessment (DRA) Score|We measured the mean change in DRA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. DRA scores range from 0-96; lower scores are better (improved dietary quality).|Baseline and 6 months|||DRA score||Standard Error|Mean
40379|NCT01452269|Primary|Weight Change|We measured the mean change in weight for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point.|Baseline and 6 months|||kilograms||Standard Error|Mean
40380|NCT01452152|Secondary|Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization||One year||||||
40381|NCT01452152|Secondary|Occurrence of Adverse Events||One year||||||
40382|NCT01452152|Secondary|Health Care Resource Utilization and Cost-effectiveness||One year||||||
40383|NCT01452152|Secondary|Post-treatment Platelet Aggregation|Platelet aggregation will be performed on a subset of subjects. Platelet aggregation studies are optional and will not be used to modulate antiplatelet therapy|10 days||||||
40384|NCT01452152|Secondary|Occurrence of Bleeding Events|Bleeding events will classified by the Bleeding Academic Research Consortium definition.|One year||||||
40385|NCT01452152|Primary|Occurrence of Post-randomization Cardiovascular Events|Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke, definite or probable stent thrombosis (ARC definition) and death secondary to any cardiovascular cause.|One year|||participants|||Number
40386|NCT01452126|Secondary|Number of Patients With Complications|All patients were followed up for complications such as bleeding, infection, side effects, nerve damage|3 days|||Participants|||Count of Participants
40387|NCT01452126|Primary|Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population|The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.|1 day|||percentage concentration, ropivacaine|||Number
40388|NCT01451983|Primary|Total Brain Volume||Baseline|MRI acquisition was performed using Siemens Q4 TIM Trio 3 tesla scanner with standard 12-channel receive-only head coil. An 8-minute whole-brain T1-weighted inversion recovery turboflash (MPRAGE) was acquired. Volumetric measurements were obtained using the software suite Freesurfer. Not all participants received imaging due to age and impairment.||cubic centimeters||Standard Deviation|Mean
40389|NCT01451931|Secondary|Accuracy for Stones by Arm||Up to 6 month follow-up for stone passage|||Percent probability||95% Confidence Interval|Number
40390|NCT01451931|Secondary|Return Visits to ED or Hospital||6 months post-baseline|||Number of visits|||Number
40391|NCT01451931|Secondary|ED Length of Stay||Baseline visit excluding hospitalization|||Hours||Inter-Quartile Range|Median
40392|NCT01451931|Primary|Cumulative Radiation Exposure||Baseline plus 6 months post-baseline|||mSv||Standard Deviation|Mean
40393|NCT01451931|Primary|High Risk Diagnosis With Complication|Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.|30 days from baseline|||participants|||Number
40394|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 26 Weeks|Biochemically verified abstinence from smoking over the past 7 days|26 Weeks|||percentage of participants abstinent|||Number
40395|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 16 Weeks|Biochemically verified abstinence from smoking over the past 7 days|16 Weeks|||percentage of participants abstinent|||Number
40396|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 8 Weeks|Biochemically verified abstinence from smoking over the past 7 days|8 weeks|||percentage of participants abstinent|||Number
40397|NCT01451775|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Screening until end of trial, average of 45 days|Treated Set(TS): TS includes all subjects who have taken at least 1 dose of trial medication||participants|||Number
40398|NCT01451775|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagloflozin (empa) in plasma, per period.~The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
40399|NCT01451775|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞).~The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
40529|NCT01450189|Secondary|Time to HIV RNA Suppression <1000 c/ml|median time to viral load suppression (<1000 c/ml)|From date of randomization until viral load suppression, up to 52 weeks|||weeks||95% Confidence Interval|Median
40530|NCT01450189|Secondary|Suppression of HIV RNA to <1000c/ml at 12 Weeks|Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks|12 weeks|||Proportion of participants||95% Confidence Interval|Number
40400|NCT01451762|Primary|Quality of Recovery 40 at 24 Hours|Scores on QOR (quality of recovery) 40 questionnaire.The QoR-40 score, which ranges from 40 to 200, representing very poor to outstanding quality of recovery, respectively.|24 hours post operatively|Primary outcome was QOR 40 a sample size of 23 per group was estimated to achieve 80% power to detect a 10 point difference in aggregated QOR040 score for the three groups. A 10 point difference represents a clinically relevant improvement in quality of recovery. TO account for drop outs lost to follow up 90 subjects were randomized.||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
40401|NCT01451749|Secondary|Change in Functional Scores: Instrumental Activities of Daily Living (IADL).|Functional ability was evaluated with the Instrumental Activities of Daily Living (IADL) IADL, at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The IADL contains eight items, which are the ability to use a telephone, shop, prepare food, run laundry, use modes of transportation, take responsibility for one’s own medications, complete housekeeping, and handle finances,each items ranges from 1 to 4 points, 1 points means no problem, and 4 points means greater impairment in instumental acvtiveity of daily living.The total is sub of the eight items, and the total range of the IADL is 8-32 points, higher scores indicate greater impairments. The changes was calculted by weeks 24 minus baseline.|Baseline to weeks 24|The efficacy measurement were conducted in the intent-to-treat population, the ITT consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.||units on a scale||95% Confidence Interval|Mean
40402|NCT01451749|Secondary|Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB)|memory function was evaluated with the DSR subtest,at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The DSR is a tool which was designed to assess immediate registration of verbal information and retention over time. It contains six sub-tests: two verbal memory tests (one of which is a story recall), two visual memory tests and two information-processing tests. The story recall test includes immediate story recall (ISR) and delayed story recall (DSR). The DSR total score ranges from 0-56 points. Lowers score means higher impairment of memory.The Change in cognitive scores was calculated as 24 week minus the baseline.|Baseline and 24 weeks|The efficacy measurement was conducted of ITT patients. The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.||units on a scale||95% Confidence Interval|Mean
40403|NCT01451749|Primary|Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)|Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) , at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24. The ADAS-cog was designed specifically to evaluate the severity of cognitive dysfunctions characteristic of AD patients and includes 11 items. Among these items, memory, orientation, language function, practical ability, and attention are evaluated. The score on the ADAS-cog range from 0 to 70 point, with 0 point indicating no impairment and 70 points indicating severe impairment of cognition. In the Shenwu capsule group, the ADAS-cog score is ranges 3-38.3 points, and 3.3-30.7 points in the Donepezil group. The Change in cognitive scores was calculated as24 week minus the baseline.|baseline and 24 weeks|the analyses for efficacy were conducted in the intent-to-treat population (ITT). The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.||units on a scale||95% Confidence Interval|Mean
40404|NCT01451723|Secondary|Brain Atrophy|Difference between the two groups in brain atrophy as measured by SIENA|1 year||||||
40405|NCT01451723|Primary|Rate of Change in NAA Levels Adjusted for Water Content.|The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.|1 year|No subjects completed either the six or twelve month point so no data was available for analysis.|||||
40406|NCT01451645|Secondary|Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||days||Standard Deviation|Mean
40407|NCT01451645|Secondary|Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||Percentage of Participants||95% Confidence Interval|Number
40408|NCT01451645|Secondary|Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||Percentage of Participants||95% Confidence Interval|Number
40409|NCT01451645|Primary|Number of Gout Flares Per Participant From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).||gout flares||Standard Deviation|Mean
40410|NCT01451632|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction||||||Number
40423|NCT01451541|Secondary|Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.||Number of Days|||Number
40556|NCT01449955|Secondary|Psychophysiology Measurements: Skin Conductance|The participant's skin conductance response is monitored during a script-driven imagery procedure. This procedure involves listening to 4 scripts: 2 neutral, 2 combat-related|one week after medication||||||
40411|NCT01451632|Secondary|Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121|Data presented by dose level of MM-121, regardless of the cohort (i.e. 15 patients in Part 1 were administered the 40/20 dose level of MM-121: 3 in cohort 3b, 4 in cohort 4, and 8 in the Part 1 expansion)||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
40412|NCT01451632|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
40413|NCT01451632|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks|||participants with objective response|||Number
40414|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD~Part 1:~Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW~Part 2:~Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs and thus not included in determining MTD/RP2D) NOTE: MTD of MM-121 provided in separate endpoint entry||mg/m2|||Number
40415|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD~Part 1:~Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW~Part 2:~Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs) MTD of cetuximab and irinotecan for the combination(s) are presented in a separate endpoint entry||mg/kg|||Number
40416|NCT01451632|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination|To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 48.1 weeks|Patients participating in dose escalation||participants reporting DLTs|||Number
40417|NCT01451554|Primary|Weight Change at 6 Months|Weight change as a percentage of baseline at post 6 months.|6 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.||percentage||Standard Deviation|Mean
40418|NCT01451554|Secondary|Weight Change at 3 Months|Percentage change in weight at 3 months post study baseline|3 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.||percentage||Standard Deviation|Mean
40419|NCT01451541|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12|||percentage of subjects|||Number
40420|NCT01451541|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12|||participants|||Number
40421|NCT01451541|Secondary|Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12|||percentage of subjects|||Number
40422|NCT01451541|Secondary|Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12|||participants|||Number
40424|NCT01451541|Secondary|Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.||units on a scale||Standard Error|Least Squares Mean
40425|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
40426|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.||units on a scale||Standard Error|Least Squares Mean
40427|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
40428|NCT01451541|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
40429|NCT01451541|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
40430|NCT01451541|Primary|The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0-6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.||units on a scale||Standard Error|Least Squares Mean
40431|NCT01451437|Secondary|Urine Concentration of MK-8242 (Part 2 Arm A Only)|The urine concentration of MK-8242 assessed as a measure of drug bioavailability was not determined due to early termination of the study (Study Part 2 was not performed).|Day 1 (predose and postdose) and Day 7 (postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (urine concentration) at the time of assessment|||||
40432|NCT01451437|Secondary|Accumulation Ratio (R) of MK-8242 Alone and in Combination With Cytarabine|The accumulation ratio (R) at steady state (based on dosing interval and apparent terminal half-life (t1/2)) for MK-8242 alone was not determined due to confounding of results by significant concentrations of a drug metabolite (M16). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (R) at the time of assessment.|||||
40433|NCT01451437|Secondary|Apparent Terminal Half-life (t1/2) for MK-8242 Alone and in Combination With Cytarabine|Elimination phase t1/2 was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (at least three time-points after Tmax).||hr||Geometric Coefficient of Variation|Geometric Mean
40434|NCT01451437|Secondary|Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine|Tmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Tmax) at the time of assessment.||Hours||Full Range|Median
40435|NCT01451437|Secondary|Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine|Cmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Cmax) at the time of assessment.||nM||Geometric Coefficient of Variation|Geometric Mean
40436|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for MK-8242 Alone and in Combination With Cytarabine|AUC0-∞ defined as AUC from time zero to infinity was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax (condition not met for 60 QD and 120 BID dose groups). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-∞) at the time of assessment.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
40437|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-last) defined as AUC from time zero to the time of last quantifiable sample was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-last) at the time of assessment.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
40438|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-24hr) defined as AUC from time zero to 24 hours was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. For the BID arms, a projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 24 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], and 24 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-24hr) at the time of assessment.||hr*nM||Geometric Coefficient of Variation|Geometric Mean
40439|NCT01451437|Secondary|Number of Participants With CRi at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at dose levels other than RP2D. CRi is defined as fulfillment of all CR criteria with exceptions for residual neutropenia (<1,000/µL), thrombocytopenia (<100,000/µL), and RBC transfusion dependence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.||Participants|||Number
40440|NCT01451437|Secondary|Number of Participants With CR at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at dose levels other than RP2D. CR is defined as a morphologic leukemia-free state with a neutrophil count ≥1,000/µL, a platelet count ≥100,000/µL, no extramedullary disease, and RBC transfusion independence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.||Participants|||Number
40441|NCT01451437|Primary|Number of Participants With Complete Remission With Incomplete Marrow Recovery (CRi) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.|||||
40442|NCT01451437|Primary|Number of Participants With Complete Remission (CR) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 wild type (WT) status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.|||||
40443|NCT01451437|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with <5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) <100/µL, platelet count <10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.|Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities|DLT-evaluable Population: participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 or discontinued due to reason of toxicity.||Participants|||Number
40444|NCT01451424|Secondary|Change in Quality of Life|Percentage change from baseline in median quality of life using uterine fibroid symptom and quality of life questionnaire (UFSQOL)|12 or 16 weeks|MITT. Note: lower score is improvement||Percent change||Full Range|Median
40445|NCT01451424|Secondary|Endometrial Thickness|Percent change in median endometrial thickness from baseline to end of treatment assessed by ultrasound determination of uterine stripe.|12 or 16 weeks|Safety population, data based on subjects with both baseline and end of treatment assessments||Percent change||Full Range|Median
40446|NCT01451424|Secondary|Induction of Amenorrhea at End of Treatment|"Percentage of subjects with induced amenorrhea during last 28 days on drug~Amenorrhea was deemed to be achieved if no daily bleeding score was greater than 1 during the last 28 calendar days of the dosing period. A score of 1 was to be indicated if spotting was observed which did not require a sanitary product. Subjects that terminated early were deemed not to have achieved amenorrhea."|End of treatment|||Percentage of particpants|||Number
40447|NCT01451424|Secondary|Uterine Fibroid Size|Percent change in volume of confirmed uterine fibroids at end of treatment, assessed by MRI|12 or 16 weeks|MITT population||Percentage change||Full Range|Median
40448|NCT01451424|Secondary|Blood Levels of Proellex|Determination of Cmax of Proellex at end of treatment|12 or 16 weeks|Subjects with end of treatment PK assessment||ng/dL||Standard Deviation|Mean
40449|NCT01451424|Primary|Change From Baseline in Vaginal Bleeding|"Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period~Less blood loss represents an improvement."|12 or 16 weeks|MITT population||mL||Full Range|Median
40450|NCT01451411|Secondary|Population Pharmacokinetics: Volume of Distribution (Vd)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median Vd|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.|||||
40451|NCT01451411|Secondary|Population Pharmacokinetics: Clearance (CL)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median CL|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.|||||
40452|NCT01451411|Secondary|Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline|an absolute serum sodium of 145 mEq/L at Hour 24 or an increase in serum sodium of greater than 12 mEq/L|baseline and Hours 3, 8, 12 and 24.|||participants|||Number
40453|NCT01451411|Secondary|Change From Baseline in Free Water Clearance (FWC)||Baseline and 48 hours|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.|||||
40454|NCT01451411|Secondary|Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours||Baseline, Hours 12, 24, 36 and 48|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.|||||
40455|NCT01451411|Secondary|Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L)||baseline and 48 hours|||participants|||Number
40456|NCT01451411|Secondary|Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||baseline and 48 hours|||participants|||Number
40457|NCT01451411|Secondary|Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||48 hours|Data from two subjects (one conivaptan, and one placebo) were censored as the serum sodium never achieved a value greater or equal to 4 mEq/L above the baseline value.||hours||Full Range|Mean
40458|NCT01451411|Primary|Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium||baseline and 48 hours|||mEq/L||Standard Deviation|Mean
40459|NCT01451398|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24||kg||Standard Error|Least Squares Mean
40473|NCT01451203|Secondary|Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR Boolean-based remission rate measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~Patient's global assessment of disease activity (PtGADA);~C-reactive protein (CRP)~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~A participant was considered to be in remission if all the criteria for each variable was met:TJC (in 28 joints) ≤1; SJC (in 28 joints) ≤1; CRP ≤1 mg/dl; PtGADA ≤1.~Last Observation Carried Forward (LOCF) was applied"|Week 24 and Week 52|FAS||percentage of participants||95% Confidence Interval|Number
40474|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Simplified Disease Activity Index (SDAI)-Based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR SDAI remission rate measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~Patient's global assessment of disease activity (PtGADA);~Physician’s Global Assessment of Disease Activity (PhGADA);~C-reactive protein (CRP)~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~A participant was considered to be in remission if SDAI ≤3.3.~Last Observation Carried Forward (LOCF) was applied."|Week 24 and Week 52|FAS||percentage of participants||95% Confidence Interval|Number
40475|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52|"The DAS28(ESR) measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~ESR;~Patient's global assessment of disease activity (PtGADA).~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A participant was considered to be in remission if DAS28(ESR) <2.6.~Last Observation Carried Forward” (LOCF) was applied."|Week 24 and Week 52|FAS||percentage of participants||95% Confidence Interval|Number
40476|NCT01451203|Secondary|Change From Baseline in mTSS at Week 24|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 24|FAS with available data.||units on a scale||Standard Deviation|Mean
40477|NCT01451203|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 52|FAS with available data.||units on a scale||Standard Deviation|Mean
40478|NCT01450800|Other Pre-specified|Antibiotic Resistance to Macrobid|We examined for macrobid resistance on urine culture results within 3 weeks of surgery|6 weeks after surgery|Examined urine cultures with susceptibility testing results for all participants who had positive urine culture results||urine culture resistant to nitrofurantoi|||Number
40479|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to postoperative catheter type|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
40480|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to total postoperative catheter days|3 weeks following surgery|Used entire study population to determine risk factors for UTI||days of catheterization||95% Confidence Interval|Median
40481|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to sling as part of surgery|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
40482|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to Creatinine Clearance|3 weeks following surgery|Used entire study population to determine risk factors for UTI||mL/min||Standard Deviation|Mean
40483|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to preoperative UTI treatment|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
40484|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to history of recurrent UTIs|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
40485|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to vaginal estrogen therapy|3 weeks following surgery|Used entire study population to determine risk factors for UTI||participants|||Number
40555|NCT01449955|Secondary|Psychophysiological Measurements: Electromyogram|The participant's left lateral frontalis and left corrugator muscle activity is monitored during a script-driven imagery procedure. This procedure involves listening to 4 scripts: 2 neutral, 2 combat-related|one week after medication||||||
40486|NCT01450800|Primary|Urinary Tract Infections|The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.|three weeks post-operative|Intent-to-treat analysis||participants|||Number
40487|NCT01450787|Other Pre-specified|Corneal Staining|Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.|at the time of the exam|All patients underwent corneal staining evaluations using fluorescein.||units on a scale|Participants|Standard Error|Mean
40488|NCT01450787|Other Pre-specified|Tear Break-up Time|The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.|at the time of the exam|Each patient underwent tear break-up time testing||seconds|Participants|Standard Error|Mean
40489|NCT01450787|Other Pre-specified|Schirmer Score|The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.|at the time of the exam|Each patient underwent schirmer testing||mm|Participants|Standard Error|Mean
40490|NCT01450787|Other Pre-specified|OSDI Score|The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.|at the time of the exam|All patients completed the OSDI survey||units on a scale||Standard Error|Mean
40491|NCT01450787|Secondary|Tear Film Osmolarity|The tear film osmolarity is measured at the time of the exam.|at the time of the exam|Tear film osmolarity was measured in all patients, but two patients in the diabetic group had an insufficient tear film to obtain a reading. Therefore, only 36 diabetics were included.||mOsml/L|Participants|Standard Error|Mean
40492|NCT01450787|Primary|Conjunctival Staining Score|Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.|at the time of the evaluation|There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.||units on a scale|Participants|Standard Error|Mean
40493|NCT01450761|Secondary|Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy|Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|From randomization until disease progression, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy||months||95% Confidence Interval|Median
40494|NCT01450761|Secondary|Overall Survival in All Randomized Participants|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization until date of death, up to March 2015, approximately 38 months|All randomized participants||months||95% Confidence Interval|Median
40495|NCT01450761|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|Randomization until date of death, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy||months||95% Confidence Interval|Median
40496|NCT01450696|Secondary|Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS|Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days)|"FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, n reflects the number of participants who were evaluable for each category in the respective arms."||μg/mL||Standard Deviation|Mean
40497|NCT01450696|Secondary|Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS|Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL.|Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, “n” reflects the number of participants who were evaluable for each category in the respective arms.||μg/mL||Standard Deviation|Mean
40498|NCT01450696|Secondary|Percentage of Participants With Objective Response - PPS|Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||percentage of participants||95% Confidence Interval|Number
40531|NCT01450189|Secondary|Proportion of Partners Reporting for HIV Testing|Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants|52 weeks|The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35)||proportion of sex partners|sexual partners|95% Confidence Interval|Number
40499|NCT01450696|Secondary|Progression-Free Survival - PPS|Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||months||95% Confidence Interval|Median
40500|NCT01450696|Secondary|Percentage of Participants With Disease Progression or Death - PPS|Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||percentage of participants|||Number
40501|NCT01450696|Secondary|Overall Survival - PPS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.||months||95% Confidence Interval|Median
40502|NCT01450696|Secondary|Percentage of Participants Who Died - Per Protocol Set (PPS)|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|The PPS included all participants who were found to have a trastuzumab minimum plasma concentration (Cmin) less than (<) 12 micrograms per milliliter (μg/mL) on treatment Day 21 of Cycle 1 following the initial loading dose of 8 mg/kg.||percentage of participants|||Number
40503|NCT01450696|Primary|Overall Survival - FAS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
40504|NCT01450696|Primary|Percentage of Participants Who Died - FAS|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.||percentage of participants|||Number
40505|NCT01450683|Primary|Reduction in Serum PSA|Number of subjects with > 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks|12 weeks treatment, with primary outcome assessed at 15 weeks|||participants|||Number
40506|NCT01450631|Secondary|Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:~Antimicrobials for surgical site infection~Surgical drainage of the incision~Surgical incision packing~Adjunctive negative pressure therapy~Debridement~Re-operation"|Post-op Day: 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.||participants|||Number
40507|NCT01450631|Primary|Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:~Unanticipated local inflammatory response~Prolonged drainage~Fluid collection~Dehiscence~Surgical site infection (SSI)"|Post-op Day 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.||participants|||Number
40508|NCT01450397|Primary|The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.|Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.|Baseline and 30 days|||mm^3||Full Range|Mean
40509|NCT01450319|Secondary|Beta 2-microglobulin||Baseline, Week 8|"MITT analysis set included all the subjects who received study drug treatment. Here n signifies number of evaluable subjects for each category, as specified."||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
40510|NCT01450319|Secondary|Overall Survival (OS) Related to Killer Inhibitory Receptors 2DS4 (KIR2DS4) Functional Receptor (f/d) and Non-functional Receptor (NFR)|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal assessed up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies number of evaluable subjects for this outcome measure."||months||95% Confidence Interval|Median
40511|NCT01450319|Secondary|Overall Survival (OS) Related to Codon G13D|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies total number of evaluable subjects for this outcome measure; “n” signifies number of evaluable subjects for each category, as specified."||months||95% Confidence Interval|Median
40512|NCT01450319|Secondary|Number of Subjects With Fcγ Receptors (FCγR) IIa/IIIa Polymorphisms|The antibody fragment C portion (FCy) of cetuximab interacts with Fc-gamma receptors (FCyRs) expressed by immune effector cells. Polymorphisms were described in genes coding for FCyRIIa and in FCyRIIIa. A histidine/arginine polymorphism at position 131 for FCyRIIa gene and valine ⁄ phenylalanine polymorphism at position 158 for the FCyRIIIa gene were reported to be functionally relevant in the ADCC mechanism. All subjects were analyzed and classified as carriers of every different polymorphism of FCy Receptors: for FCyRIIa (H/H, homozygous alleles with histidine and R/H, heterozygous alleles with arginine/histidine) and FCyRIIIa (V/V, homozygous alleles with valine, F/F, homozygous alleles with phenylalanine and F/V, heterozygous alleles with valine ⁄ phenylalanine) (units: subjects with every type of polymorphism) .The FCyR genotype was determined using a TaqMan Allelic Discrimination Assay.|Baseline|MITT analysis set included all the subjects who received study drug treatment. Subjects may fall into more than one category.||Subjects|||Number
40513|NCT01450319|Secondary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, AEs Leading to Death|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the date of enrollment up to 30 days after the last dose of study drug administration, assessed up to 3 years|Safety analysis set included all the subjects who received at least one dose of the study drug treatment.||Subjects|||Number
40514|NCT01450319|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the time from informed consent signature until PD or death, whatever occurred first. Subjects who did not have disease progression or were lost to follow-up, were censored at the date of last contact, known to be alive and progression free; moreover, those subjects who started a new treatment (different from cetuximab), were censored at the date of starting the new treatment. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|From the date of informed consent signature until progressive disease (PD) or death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.||Months||95% Confidence Interval|Median
40515|NCT01450319|Secondary|Percentage of Subjects With Disease Control Rate (DCR)|DCR was defined as those subjects achieving complete response (CR), partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of longest diameter (SLD) of the TLs, taking as a reference the baseline (BL) SLD; Stable disease (SD) was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and progressive disease (PD) was defined as the appearance|From the date of informed consent signature until progressive disease, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.||Percentage of subjects|||Number
40516|NCT01450319|Primary|Overall Survival (OS) Time|Overall survival was defined as the time from date of informed consent signature until death.|From the date of informed consent signature until death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.||Months||95% Confidence Interval|Median
40517|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Improvement|"Clinician rating of global illness severity (at post-treatment)~CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2"|2 weeks|||participants|||Number
40518|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Severity|"Clinician rating of global illness severity (at pre- and post-treatment)~CGI-Severity range 1-7; higher scores indicate greater illness severity."|2 weeks|||units on a scale||Standard Deviation|Mean
40519|NCT01450306|Primary|Snake Questionnaire (SNAQ)|"30-item self-report scale of severity of snake fear and avoidance~Range: 0-30; higher values indicate greater fear severity"|2 weeks|||units on a scale||Standard Deviation|Mean
40520|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Men|median HIV RNA concentration as measured in semen|52 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
40521|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Men|median HIV RNA concentration as measured in semen|26 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
40522|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Men|median HIV RNA concentration as measured in semen|12 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
40523|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Women|median HIV RNA concentration in cervical lavage fluid|52 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
40524|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Women|median HIV RNA concentration in cervical lavage fluid|26 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
40525|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Women|median HIV RNA concentration in cervical lavage fluid|12 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.||copies/ml||Full Range|Median
40526|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 52||52 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.||copies/ml||Full Range|Median
40533|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.|52 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52||Proportion of participants||95% Confidence Interval|Number
40534|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.|26 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26||Proportion of participants||95% Confidence Interval|Number
40535|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|At least one incident infection with either gonorrhea, chlamydia or trichomoniasis|52 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26||proportion of participants||95% Confidence Interval|Number
40536|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis|26 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests||proportion of participants||95% Confidence Interval|Number
40537|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 52 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/month||95% Confidence Interval|Mean
40538|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 26 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/month||95% Confidence Interval|Mean
40539|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 12 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/month||95% Confidence Interval|Mean
40540|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 52 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/week||95% Confidence Interval|Mean
40541|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 26 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/week||95% Confidence Interval|Mean
40542|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 12 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit||unprotected sex acts/week||95% Confidence Interval|Mean
40543|NCT01450189|Primary|Number of Adverse Events|Mean number of adverse events per group|one year|||number of events||95% Confidence Interval|Mean
40544|NCT01450189|Primary|Proportion of Persons Completing All Scheduled Visits in Each Study Arm||1 year|||Proportion of participants||95% Confidence Interval|Number
40545|NCT01450189|Primary|Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.|In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.|1 year|All persons in the two behavioral intervention arms||proportion of participants||95% Confidence Interval|Number
40546|NCT01450189|Primary|Proportion of Participants Completing Full Course of ARVs in Arm BIA|Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that|1 year|Number of persons in BIA arm eligible for study-provided ARVs||proportion of BIA participants||95% Confidence Interval|Number
40547|NCT01450189|Primary|Proportion of Persons With AHI Successfully Recruited Into the Study|This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.|1 year|||Proportion of persons with AHI recruited||95% Confidence Interval|Number
40548|NCT01450189|Primary|Prevalence of AHI Among Persons Screened|Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.|1 year|||proportion of participants||95% Confidence Interval|Number
40549|NCT01450189|Primary|Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening||1 year|All persons screened||proportion of participants screened||95% Confidence Interval|Number
40550|NCT01450007|Secondary|Patient Satisfaction With Pain Control|Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.|24 hours, 48 hours, 1 week|Patients analyzed for each category varied see explanations per row (time point): (n=dexamethasone block, dexamethasone IV, placebo).||units on a scale||Standard Deviation|Mean
40551|NCT01450007|Secondary|Time Until First Dose of Analgesic||Approximately 10 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.||hours||Standard Deviation|Mean
40552|NCT01450007|Secondary|Post Operative Opioid Dose at 24 Hours||approximately 24 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.||mg morphine equivalents||Standard Deviation|Mean
40553|NCT01450007|Primary|Duration of Sensory Blockade|Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.|Within 48 hours|Patients will be included in the primary analysis on the basis of intention to treat.||hours||Standard Deviation|Mean
40554|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report measure of the intensity of PTSD symptoms|change in PCL score from baseline to one week posttreatment||||||
40563|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|The CAPS is administered to assess the frequency and intensity of PTSD symptoms at baseline, and then again 3 months posttreatment.|change in CAPS score from baseline to 3 months posttreatment||||||
40564|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|Clinician administered interview which assesses the symptoms of Posttraumatic Stress disorder at baseline, and then again 1 month posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.|Baseline and 1 month posttreatment|||scores on a scale||Standard Deviation|Mean
40565|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Convenience Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The convenience score is the score for item 5 (range: 0-6).|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.||Scores on a scale||Standard Deviation|Mean
40566|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Lifestyle/Ease Sub Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The lifestyle/ease score is the sum of items 4, 5, 6, 7 and 8 (range: 0-30).|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.||Scores on a scale||Standard Deviation|Mean
40567|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Total Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The treatment satisfaction score (range: 0-60) was the sum of the individual items. HIVTSQ mITT-E Population=Only participants from USA, France, Germany, Italy, Spain for whom valid translations were available from the mITT-E Population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.||Scores on a scale||Standard Deviation|Mean
40568|NCT01449929|Secondary|Change From Baseline in EQ-5D Thermometer Scores at Week 24 and Week 48|The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. Thermometer score is based on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, Baseline viral load, background dual NRTI therapy and Baseline EQ-5D thermometer score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Scores on a scale||Standard Error|Mean
40569|NCT01449929|Secondary|Change From Baseline in EQ-5D Utility Scores at Week 24 and Week 48|The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and Baseline EQ-5D utility score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Scores on a scale||Standard Error|Mean
40594|NCT01449526|Secondary|Slit Lamp > Grade 2|Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.|3 months|Number of dispensed eyes with non-missing scores in each treatment group.||eyes (2 per participant)|Participants||Number
40570|NCT01449929|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Bother Score at Week 4, Week 24, and Week 48|SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and baseline symptom bother score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicates a decline in a participant’s quality of life over that period.|Baseline, Week 4, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Scores on a scale||Standard Error|Mean
40571|NCT01449929|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Resistance to DTG, DRV+RTV and Other On-study ART at Time of Protocol Defined Virology Failure (PDVF)|An assessment was made of every change across all amino acids within the integrase (IN), reverse transcriptase (RT), and Protease (PRO) encoding region at Baseline and at time of suspected PDVF. PDVF is defined as the confirmed plasma HIV-1 RNA >200 c/mL >=Week 24.|Baseline until PDVF up to Week 48|PDVF Genotypic Population: all participants in the mITT-E population with available on-treatment genotypic resistance data, at time of PDVF. Only those participants with data available at the specified time points were analyzed.||Participants|||Number
40572|NCT01449929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Maximum Post-Baseline Chemistry and Hematology Laboratory Toxicities|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred.|From Baseline through Week 48|mSafety Population||Participants|||Number
40573|NCT01449929|Secondary|Percentage of Participants With Grade 2 or Higher Abnormalities in Fasting LDL Cholesterol Through Week 48|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for which an increase in fasting LDL cholesterol to Grade 2 or higher occurred.|From Baseline through Week 48|mSafety Population. Only those participants with data available at the specified time points were analyzed.||Percentage of Participants|||Number
40574|NCT01449929|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol Through Week 48|Fasting LDL cholesterol change from Baseline was analyzed. Values represented are for adjusted means. Estimates are calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, background dual NRTI therapy, Baseline LDL cholesterol, treatment*visit interaction and Baseline LDL cholesterol*visit interaction. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline through Week 48|mSafety Population. Only those participants with data available at the specified time points were analyzed.||millimoles per liter (mmol/L)||Standard Error|Mean
40575|NCT01449929|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shift to CDC Class C, or New CDC Class C or Death at Week 48|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|Week 48|mITT-E Population||Participants|||Number
40576|NCT01449929|Secondary|Change From Baseline in CD4+ and CD8+ Cell Counts|Change from Baseline in CD4+ cell counts was assessed at Weeks 4, 8, 12, 16, 36 and 48. Change from Baseline in CD8+ cell counts was assessed at Weeks 4, 12, 24 and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 4, 8, 12, 16, 36 and 48 for CD4+ and Baseline and Weeks 4, 12, 24 and 48 for CD8+|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits and parameters, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
40577|NCT01449929|Secondary|Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48|Change from Baseline in plasma HIV-1 RNA (log10 c/mL) was assessed at Weeks 4, 8, 12, 16, 24, 36 and 48 . Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 4, 8, 12, 16, 24, 36 and 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.||Log10 copies per mL||Standard Deviation|Mean
40595|NCT01449526|Primary|Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.|4 visits over 3 months|All Eligible, Dispensed Eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
40596|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40578|NCT01449929|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at Week 48 was assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks)."|Week 48|mITT-E Population||Percentage of participants|||Number
40579|NCT01449929|Secondary|Time to Virologic Suppression (<50 Copies/mL) Through Week 48|The time to viral suppression (i.e. first viral load value <50 copies/mL) through Week 48 was derived and summarized using Kaplan-Meier plots. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. Confidence intervals were estimated using the Brookmeyer-Crowley method.|From Baseline through Week 48|mITT-E Population||Days||95% Confidence Interval|Median
40580|NCT01449929|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks)."|Week 48|Modified Intent-To-Treat Exposed (mITT-E) Population: all randomized participants who received at least one dose of investigational product excluding one participant at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV Healthcare sponsored trial.||Percentage of participants|||Number
40581|NCT01449747|Primary|Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1, total GLP-1 and total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurements were measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Comparisons were made using Area under the curve (AUC) values and incremental area under the curve (ΔAUC) of active GLP-1, total GLP-1 and total GIP before and after the addition of sitagliptin.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol*min/L||Standard Deviation|Mean
40582|NCT01449747|Primary|Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment|Plasma concentrations of total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GIP were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol/L||Standard Deviation|Mean
40583|NCT01449747|Primary|Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment|Plasma concentrations of total GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol/L||Standard Deviation|Mean
40584|NCT01449747|Secondary|Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups|The DPP-4 activity was measured at baseline and 0, 15, 30, 45 and 60 min during the meal tolerance test. Second measurement of DPP-4 activity was measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Plasma DPP-4 activity during meal tolerance test is expressed as percentage activity relative to baseline. DPP-4 activity % was calculated using the following formula : (DPP-4 activity at time t / Baseline DPP-4 activity) × 100.|0, 15, 30, 45, 60 min post-dose|||percentage of DPP4 activity||Standard Deviation|Mean
40585|NCT01449747|Primary|Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose|||pmol/L||Standard Deviation|Mean
40586|NCT01449734|Primary|Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score|Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making. After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied).|From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|By invitation||units on a scale||Standard Deviation|Mean
40587|NCT01449734|Secondary|Patient Mortality||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months||||||
40588|NCT01449734|Secondary|Patient Length of Stay on the ICU||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months||||||
40589|NCT01449734|Secondary|Patient Severity of Illness||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months||||||
40590|NCT01449708|Secondary|PONV Between Different Surgical Procedures (Percentage of Participants)||24 hours|analysis was conducted with all participants and NOT per arm||percentage of participants|||Number
40591|NCT01449708|Secondary|Number of Patients Requiring Antiemetic Rescue Medication (AERM)||24hours|||participants|||Number
40592|NCT01449708|Primary|PONV During the First 24 Hours After Bariatric Surgery|Postoperative Nausea and Vomiting|24 hours|||participants|||Number
40593|NCT01449539|Primary|Number of Stem Cells Collected|Total stem cells collected from all participants at one week post-study treatment|one week post-treatment|Four of eight enrolled subjects completed the study.||stem cells|||Number
40597|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40598|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40599|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel,0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40600|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40601|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40602|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40603|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40604|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM(Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40605|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40606|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40607|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40608|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40609|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40610|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40611|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40612|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40613|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40614|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40615|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40616|NCT01449513|Primary|Change in Degree of Infiltration|Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40617|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40701|NCT01447433|Secondary|Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||kg||Standard Error|Mean
40618|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in Sub actinic keratosis (AK) skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage of change||Standard Deviation|Mean
40619|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in actinic keratosis (AK) skin.This RCM imaging technique is a relatively new non-invasive, real-time evaluation method to generate horizontal skin sections at a resolution comparable to routine histology.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.||percentage change||Standard Deviation|Mean
40620|NCT01449305|Other Pre-specified|Medicine Administration for Pain Relief During Study Period|Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.|first menstrual cycle, second menstrual cycle and third menstrual cycle|It was analyzed based on the PP population.||percentage of participants|||Number
40621|NCT01449305|Primary|The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline|The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).|baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle|Subjects were asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles in house. Primary objective was analyzed based on the Per-protocol (PP) population.||scores||Standard Deviation|Mean
40622|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|The evaluation of the decrease in seric concentration of gadolinium, 4h after the third hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of detection were kept for analysis.|Dotarem® dialysability assessed 4h after third hemodialysis session which took place 4 days after Dotarem® administration|8 subjects had a gadolinium concentration <LLQ after third hemodialysis session||percent change in Gd concentration||Full Range|Geometric Mean
40623|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|Evaluation of the decrease in seric concentration of gadolinium, 4h after the second hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of quantification (LLQ) were kept for analysis.|Dotarem® dialysability assessed 4h after second hemodialysis session which took place 2 days after Dotarem® administration|3 subjects had a gadolinium concentration <LLQ after the second hemodialysis session||Percent change in Gd concentration||Full Range|Geometric Mean
40624|NCT01449266|Secondary|Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.|To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.|Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration|||participants|||Number
40625|NCT01449266|Primary|Dialysability of Dotarem® in Dialysed Patients|To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)|Dotarem® dialysability assessed up to 4 days after Dotarem® administration|After second hemodialysis, 3 subjects had Gd concentration<LLQ and are not included in the analysis; after third hemodialysis, 8 subjects had Gd concentration<LLQ and are not included in the analysis||percent change in Gd concentration||Full Range|Geometric Mean
40626|NCT01449240|Secondary|Levels of GAG in Urine|The levels of GAG (including sulfated DS/HS oligosaccharides) in urine were determined by the Blyscan sulfated GAG assay kit. The concentration of GAG in urine was normalized to the urine creatinine value and reported as mg GAG/mmol creatinine.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. Urinary GAG was not measured in 2 patients: 1 pediatric patient who provided a retrospective CSF sample only (no urine sample was collected) and 1 adult patient whose CSF sample was not considered evaluable and therefore their urinary GAG was not measured.||mg GAG/mmol Creatinine||95% Confidence Interval|Mean
40627|NCT01449240|Primary|Levels of Total Glycosaminoglycan (GAG) in CSF|The concentration of total GAG, including heparan sulfate (HS) and dermatan sulfate (DS) oligosaccharides, in CSF was measured using an enzymatic assay.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. This included a pediatric patient who was consented to provide a retrospective CSF sample.||ng/mL||95% Confidence Interval|Mean
40750|NCT01445951|Other Pre-specified|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population||percentage of participants|||Number
40628|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H2O as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.||ratio||Standard Error|Least Squares Mean
40629|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echot time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.||ratio||Standard Error|Least Squares Mean
40630|NCT01449006|Secondary|Change in CSF Neopterin Concentration|Change in concentration of the CSF neuroinflammatory marker neopterin (measured in nmol/L) from baseline to 12-months.|Baseline and 12-months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control and n=2 maraviroc who did not provide a CSF sample at 12-months.||nmol/L||Standard Error|Least Squares Mean
40631|NCT01449006|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6-months and 12-months|Modified intent-to-treat analysis. All randomized participants were included except for n=2 controls with baseline data only (1 lost to follow-up, 1 withdrew before 6-months) and n=1 control where a protocol violation was noted (randomized without conclusive evidence of neurocognitive impairment - see participant flow section).||Global Neurocognitive Z-Score||Standard Error|Least Squares Mean
40632|NCT01448850|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit|Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.|Day 1 up to Week 69|Immunogenicity (IM) population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum sample for IM testing.||participants|||Number
40633|NCT01448850|Secondary|Observed Serum Concentrations of MEDI8968||Pre-dose (Baseline), Post-dose on Week 53|PK population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum concentration.||nanogram per milliliters (ng/mL)||Standard Deviation|Mean
40634|NCT01448850|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to Week 69|Safety population included all participants who were randomized and received at least one dose of investigational product.||participants|||Number
40635|NCT01448850|Secondary|Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.||percentage of participants|||Number
40636|NCT01448850|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.||units on a scale||Standard Error|Mean
40645|NCT01448707|Secondary|Change From Baseline in Global Neurocognitive Performance z-Score|Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).|Baseline, Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Units on a Scale||Standard Error|Mean
40637|NCT01448850|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total Score|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.|Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of participants|||Number
40638|NCT01448850|Secondary|Change From Baseline in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Error|Mean
40639|NCT01448850|Secondary|Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.||days||Inter-Quartile Range|Median
40640|NCT01448850|Secondary|Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.||AECOPD events/year||90% Confidence Interval|Mean
40641|NCT01448850|Primary|Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.||AECOPD events/year||90% Confidence Interval|Mean
40642|NCT01448707|Secondary|Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results|The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL >400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.|Over 48 and 96 Weeks|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Participants|||Number
40643|NCT01448707|Secondary|Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance|The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA >= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).|At Weeks 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Participants|||Number
40644|NCT01448707|Secondary|Time to Loss of Virologic Response|Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA >= 50 copies/mL or premature discontinuation.|Baseline up to Week 96 or early withdrawal|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Days||Full Range|Median
40646|NCT01448707|Secondary|Virologic Response (FDA Snapshot, Switch Included)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.|Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Percentage of Participants|||Number
40647|NCT01448707|Secondary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol.|Week 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Percentage of Participants|||Number
40648|NCT01448707|Primary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.|Week 48|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.||Percentage of Participants|||Number
40649|NCT01448616|Secondary|Asymptomatic Shedding (Shedding on Days Without Genital Lesions)|"Within person changes in shedding on days without lesions between the lead-in (observational) phase and the study drug (treatment) phase. Each arm is evaluated separately and no inter arm comparisons are made.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|All randomized participants are included in ITT analysis. Per protocol analysis includes persons receiving 30 or more days of study drug with >90% adherence as documented by returned product counts.||% days with asymptomatic shedding||95% Confidence Interval|Number
40650|NCT01448616|Secondary|Genital Lesion Rate|"The within person change in proportion of days with lesions between the lead-in (observational) and study drug (treatment) phase for each arm separately. No between arm comparisons were performed. We include intent to treat with all randomized participants as well as per protocol (persons receiving study drug for at least 30 days with 90% or better reported compliance per returned product counts).~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|||percentage of days with lesions (%)||95% Confidence Interval|Number
40651|NCT01448616|Secondary|Within-person Changes in Log-copy Numbers of HSV|"The within-person changes in mean log-copy numbers of HSV shed during treatment phase (oral TDF, vaginal TFV, or double placebo) compared with the lead-in (observation) phase in the same participants. Each treatment arm is analyzed separately without comparison between arms.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|Analysis is within person changes such that the observational group contributed to analyses of those persons in each treatment randomization group||log-copy number of HSV DNA shed||95% Confidence Interval|Mean
40652|NCT01448616|Primary|HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo|The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms.|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|This includes intent to treat, ( all randomized participants) and per-protocol analyses (persons receiving 30 or more days of treatment with >90% compliance as recorded by returned product counts)||percentage of swabs positive (%)||95% Confidence Interval|Number
40653|NCT01448525|Secondary|Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score|The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.|Baseline, Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.||Percentage of participants|||Number
40654|NCT01448525|Primary|Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported."|Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.||Percentage of participants|||Number
40655|NCT01448486|Secondary|Cerebrospinal Fluid|To determine if there is improvement in CSF neopterin concentrations with the addition of Raltegravir.|Baseline and 12 months|Study was terminated prematurely with an incomplete study dataset before any meaningful analyses of the data could be conducted. CSF was not collected at 12 months for n=1 raltegravir and n=1 control who refused lumbar puncture.||nmol/L||Standard Error|Mean
40656|NCT01448486|Primary|Neurocognitive Function|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6 months and 12 months|Study was terminated prematurely with an incomplete study dataset any before any meaningful statistical analysis of the data (including change over the study time-points) could be performed.||Global Neurocognitive Z-Score||Standard Error|Mean
40657|NCT01448356|Secondary|Tear Film Break up Time|After instillation of fluorescein, the participant will then be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye.|20 minutes after the required temperature and humidity in the chamber is achieved|||seconds||95% Confidence Interval|Mean
40658|NCT01448356|Primary|Tear Evaporation Rate|The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.|20 minutes after the required temperature and humidity in the chamber is achieved|||Watt/meter^2||95% Confidence Interval|Mean
40659|NCT01448213|Secondary|Number of Eyes With Intraocular Pressure (IOP) Elevation|Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.|one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK|||eyes|Participants||Number
40660|NCT01448213|Primary|Number of Eyes With Immunologic Graft Rejection Episodes||Within 1 year|||eyes|Participants||Number
40661|NCT01448057|Secondary|Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms|Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms|Day 3|In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm||mm||Standard Deviation|Mean
40662|NCT01448057|Primary|Physician Global Evaluation of Effectiveness on Nasal Symptoms|"The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.~Range from 1 to 5 where 1 is excellent and 5 is bad :~1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms"|Day 2|In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm||score on a scale||Standard Deviation|Mean
40663|NCT01448044|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|From Day 1 (start of study treatment) up to Follow-up Week 4|Analysis was performed on all treated participants.||participants|||Number
40664|NCT01448044|Secondary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.|Post Treatment Weeks 12, 24|For SVR12; analysis was performed by backward imputation method, For SVR24: analysis was performed in Modified ITT population.||Percentage of participants|||Number
40665|NCT01448044|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels|Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48|The analysis was performed in modified ITT population.||Percentage of participants||95% Confidence Interval|Number
40666|NCT01448044|Secondary|Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)|Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48|The analysis was performed in modified ITT population.||Percentage of participants||95% Confidence Interval|Number
40667|NCT01448044|Primary|Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)|Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.|Week 12 (Follow-up period)|The analysis was performed in modified Intent to treat population (ITT), defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. Missing values were imputed using backward imputation technique.||Percentage of participants||95% Confidence Interval|Number
40668|NCT01447927|Secondary|Overall Adverse Event Rates|"Number of patients that experienced adverse events (grade 1 or above) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v. 4.0.~The data reported in the table include only the commonly occurring adverse events (3 or more events)."|Up to 30 days|||participants|||Number
40669|NCT01447927|Primary|Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus|The percent change in pS6K1 was calculated as month 3 pS6k1 values minus baseline pS6k1 values, then divide by baseline pS6k1 values and multiply by 100.|Baseline to 3 months|Participants were considered evaluable for primary endpoint if pS6K1 data were available from both the pre- and post-intervention evaluations based on the intent-to-treat principle.||percentage of change||Full Range|Median
40670|NCT01447914|Post-Hoc|Cycles of Tivantinib Treatment Administered|Number of treatment cycles completed by study participants.|From start of participant treatment to completion or disease progression; Data collected for overall study period January 2012 to February 2014.|||number of treatment cycles||Full Range|Mean
40671|NCT01447914|Secondary|Time to Next Treatment (TTNT)|Kaplan and Meier product limit methods will be used to estimate the TTNT with 95% confidence intervals.|From registration on trial to next treatment or death due to any cause, whichever comes first, assessed up to 30 days||||||
40673|NCT01447914|Secondary|Progression-free Survival (PFS)|Kaplan and Meier product limit methods will be used to estimate the median PFS with 95% confidence intervals. Furthermore, the univariate and multivariate Cox proportional hazards regression model will be used to identify prognostic factors for PFS.|From start of the treatment to disease progression or death (regardless of cause of death), whichever comes first, assessed up to 30 days||||||
40674|NCT01447914|Primary|Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4|Toxicities with a grade 3 nonhematologic or grade 4 hematologic toxicities according to CTCAE, version 4. Grade 3 and estimated with a 95% credible interval. Summary statistics will be provided for continuous variables.|Up to 30 days||||||
40675|NCT01447914|Primary|Overall Response Rate (ORR)|ORR using International Myeloma Working Group Response Criteria, achieve at least a partial response (PR) or better: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR): CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour; Stable Disease (SD): Not CR, VGPR, PR or progressive disease; Progressive Disease (PD):>25% from lowest value Serum and/or Urine M-component, new lesions or soft tissue plasmacytomas, or hypercalcemia.|Up to 30 days|Proportion of participants reported on an intent-to-treat basis.||participants|||Number
40676|NCT01447849|Secondary|Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.|The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.|To provide 0.80 statistical power for detection of significance.||Centipoises||Standard Error|Mean
40677|NCT01447849|Primary|Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.|The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.|Number of participants was calculated to provide statistical power of 0.80 for detection of significance.||mg/hour||Standard Error|Mean
40678|NCT01447719|Other Pre-specified|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|at autopsy within 12 months of florbetapir PET scan|Includes only those subjects with time from scan to autopsy less than one year.||florbetapir PET scans|||Number
40679|NCT01447719|Other Pre-specified|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|at autopsy within 24 months of florbetapir PET scan|||florbetapir PET scans|||Number
40680|NCT01447719|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|at autopsy within 24 months of florbetapir PET scan|||percentage of true positives/negatives||Full Range|Median
40681|NCT01447719|Secondary|Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|18 of 46 subjects who died within 1 year of scan had no or sparse neuritic plaques at autopsy||participants|||Number
40682|NCT01447719|Secondary|Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|28 of 46 subjects who died within 1 year of scan had moderate to frequent neuritic plaques at autopsy||participants|||Number
40683|NCT01447719|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy within 24 months of florbetapir PET scan|||Correlation coefficient||95% Confidence Interval|Number
40684|NCT01447719|Primary|Specificity Analysis in All Autopsy Population|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|20 of 59 subjects from the all autopsy population had no or sparse neuritic plaques at autopsy||participants|||Number
40685|NCT01447719|Primary|Sensitivity Analysis in All Autopsy Population|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|39 of 59 subjects from all autopsy population had moderate to frequent neuritic plaques at autopsy||participants|||Number
40751|NCT01445951|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set (subjects with data available at Baseline and at Week 24)||kg||Standard Error|Least Squares Mean
40686|NCT01447706|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Paclitaxel in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to Paclitaxel can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 3.9 years|Patients with available tissue for RNA-ISH analysis||months PFS||95% Confidence Interval|Median
40687|NCT01447706|Secondary|Overall Survival|To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, with a median of approximately 13 months|||months||95% Confidence Interval|Median
40688|NCT01447706|Primary|Progression Free Survival|"To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 3.9 years|||months||95% Confidence Interval|Median
40689|NCT01447576|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.|The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and atleast 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.||Units on a scale||Standard Deviation|Mean
40690|NCT01447576|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.|The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and at least 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.||Units on a scale||Standard Deviation|Mean
40691|NCT01447576|Primary|Participants With Adverse Events (AEs).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.|After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit|The primary safety dataset included all participants exposed to at least 1 dose of brexpiprazole.||Participants|||Number
40692|NCT01447511|Primary|Warfarin Clearance.|Warfarin enantiomer (S-warfarin and R-warfarin) clearance was measured in healthy volunteers genotyped for CYP2C9*1/*1, CYP2C9*1B/*1B, CYP2C9*1/*3, CYP2C9*2/*3 and CYP2C9*3/*3 to determine the magnitude of the warfarin-fluconazole (inhibition) and warfarin-rifampin (induction) drug interactions.|Over three (two for CYP2C9*1B/*1B participants) 12-16 day study periods.|Participants with the CYP2C9*1B/*1B haplotype did not participate in the fluconazole period (inhibition). One CYP2C9*1/*3 participant only completed the control period. One CYP2C9*2/*3 participant only completed the control and fluconazole (inhibition) study periods.||mL/h||Standard Deviation|Mean
40693|NCT01447433|Secondary|Change in Energy Intakes||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||kcal/d||Standard Deviation|Mean
40694|NCT01447433|Secondary|Change in Fasting Plasma Insulin||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mIU/L||Standard Deviation|Mean
40695|NCT01447433|Secondary|Change in Fasting Plasma Glucose||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mmol/L||Standard Deviation|Mean
40696|NCT01447433|Secondary|Change in Lipid-lipoprotein Profile||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mmol/L||Standard Deviation|Mean
40697|NCT01447433|Secondary|Change in Blood Pressure|Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||mm Hg||Standard Deviation|Mean
40698|NCT01447433|Secondary|Change in Waist, Abdominal and Hip Circumference|Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||cm||Standard Deviation|Mean
40699|NCT01447433|Secondary|Change in Visceral Fat Area|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||cm^2||Standard Deviation|Median
40700|NCT01447433|Secondary|Change in Fat Percentage|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||Percentage of body weight||Standard Deviation|Mean
40702|NCT01447433|Primary|Change in Body Weight|Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.||kg||Standard Deviation|Mean
40703|NCT01447420|Secondary|Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12|Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.|From Baseline (Week 0) to Week 12|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline. Participants with available data at the time of evaluation were analyzed.||participants|||Number
40704|NCT01447420|Secondary|Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment|Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.|Up to Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.||participants|||Number
40705|NCT01447420|Secondary|Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression|Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.|Weeks 4, 12, 24, 48, 60 and 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.||participants|||Number
40706|NCT01447420|Primary|Percentage of Participants With Incidence of Anemia|Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.|Up to Week 72|Safety population included all enrolled participants who received at least one dose of any study medication.||Percentage of participants||95% Confidence Interval|Number
40707|NCT01447420|Primary|Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression|Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.|At Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at Baseline (Week 0).||Percentage of participants||95% Confidence Interval|Number
40708|NCT01447225|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction||||||Number
40709|NCT01447225|Secondary|Pharmacokinetics (AUClast)|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2).|Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
40710|NCT01447225|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg).|Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
40711|NCT01447225|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 88.1 weeks|||participants with objective response|||Number
40712|NCT01447225|Primary|To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies|To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 88.1 weeks|||participants reporting DLTs|||Number
40713|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks|||mg/m2|||Number
40714|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks|||mg/m2|||Number
40715|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin|"Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula~Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks|||target AUC (mg*min/mL)|||Number
40716|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8"|From date of first dose to 30 days after termination, the longest 88.1 weeks|NOTE: Maximum tolerated dose is for the combination of gemcitabine and MM-121. MTD of MM-121 is provided in separate endpoint.||mg/m2|||Number
40717|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks|Note: data provided below is for MM-121 doses only for the combination. Combination therapy MTDs are provided in separate endpoint measures.||mg/kg|||Number
40718|NCT01447225|Primary|To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies|Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting|From date of first dose to 30 days after termination, the longest 88.1 weeks|||participants reporting adverse events|||Number
40730|NCT01446419|Secondary|Change in ODI From Baseline to 6 Months Post-treatment|"The improvement in ODI at 6 months compared to baseline.~ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|6 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.||units on a scale||95% Confidence Interval|Least Squares Mean
40719|NCT01447121|Secondary|Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results.|1 hour|115 (115x1) test results are possible. Staff tested blood from 118 subjects (one of 3 test strip lots). All study results from 2 subjects were excluded from data analyses as already described. Also, one test exceeded time interval (defined in protocol) between meter test and reference method.||BG test results|||Number
40720|NCT01447121|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|115(115x1)test results are possible. 118 subjects tested one of 3 test strip lots on the BGM system. Study results from 2 subjects were excluded from all data analyses as already described. One subject test exceeded time interval (defined in protocol) between meter test and reference method.||BG test results|Participants||Number
40721|NCT01447017|Primary|Adverse Events (AEs)|"AEs were collected by a non-leading question such as have you experienced any new health problems or worsening of existing conditions as well as reporting events directly observed or spontaneously volunteered by patients. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were recorded as an AE including the following information: Diagnosis; Start date (and time, if relevant), Stop date (and time, if relevant) or resolution; Severity; Action taken; Causality; Seriousness; Outcome."|"AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational medicinal product (IMP), previously reported AEs were followed up and assessed as recovered or not recovered."|All safety analyses were performed on safety analysis set. All randomised patients who received at least 1 dose of the IMP and had at least 1 safety follow-up performed were included in the safety analysis set.||participants|||Number
40722|NCT01446796|Secondary|Functional Capacity and Symptoms|To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.|14 days|Study terminated early due to low accrual. No data analysis completed.|||||
40723|NCT01446796|Secondary|Right Ventricular Function|To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.|14 days|Study terminated early due to low accrual. No data analysis completed.|||||
40724|NCT01446796|Secondary|Post-operative Need for Hemodynamic / Respiratory Support|To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.|14 days|Study terminated early due to low accrual. No data analysis completed.|||||
40725|NCT01446796|Primary|Length of Hospitalization|To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.|14 days|Study terminated early|||||
40726|NCT01446705|Secondary|Health Care Quality: Care Sensitive Admissions|This study will use the Agency for Healthcare Research and Quality's (AHRQ) Prevention Quality Indicators (PQI) to calculate the outcome measure. The PQIs are a set of measures used with hospital inpatient data to identify ambulatory care sensitive conditions. The PQIs consist of 14 conditions. The study will adopt 12 that are commonly used for adult patients: angina, asthma, bacterial pneumonia, chronic obstructive pulmonary disease, congestive heart failure, dehydration, diabetes long-term complications, diabetes short-term complications, diabetes uncontrolled, hypertension, lower-limb amputation among diabetes patients, and urinary infection.|3 years||12/2016||||
40727|NCT01446705|Primary|Health Care Quality: Ambulatory Care Performance Measures|This study will measure the impact of HIE upon health care quality the underuse of ambulatory care services. Measurements of underuse before and after implementation will detect improvements in the quality of care. To measure underuse, the study employs a measurement set that is sensitive to the potential effects and feasible for electronic data capture. 15 measures have been chosen, falling in the areas of prevention, diabetes, asthma, cardiovascular disease, congestive heart failure, mental health and osteoporosis.|3 years||12/2016||||
40728|NCT01446705|Primary|Effect of Health Information Exchange on Cost|Before after analysis of the presence of health information exchange on costs within the VA healthcare system; Measure is cost, unadjusted, in dollars for the year post enrollment in the health information exchange|2 Years|5269 individuals were excluded due to lacking cost information.||$ per year unadjusted total VA cost||Standard Deviation|Median
40729|NCT01446705|Primary|Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data|Determining rates of usage of healthcare by veterans by source of data. This will clue us into any differences in utilization patterns between groups.|2 years|Veterans divided into enrolled and non-enrolled in HIE groups||participants|||Number
40745|NCT01446250|Primary|Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.|||||
40746|NCT01445951|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set||percentage of participants|||Number
40752|NCT01445951|Secondary|Mean 7-point Glucose Week 24 Values||Week 24|Full analysis set||mg/dL||Standard Deviation|Mean
40731|NCT01446419|Secondary|Patient Success at 3 Months|"Proportion of subjects with clinical success at 3 months, where clinical success was defined as:~3 month ODI score represented at least a 15-point reduction from baseline~no device or procedure related SAE between baseline and 3 mos.~no increase in opioid use between procedure and 3 mos.~no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.~no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.||percentage of patients|||Number
40732|NCT01446419|Primary|Change in ODI From Baseline to 3 Months Post-treatment|"The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.~ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.||units on a scale||95% Confidence Interval|Least Squares Mean
40733|NCT01446289|Secondary|Percentages of Infants Reporting SAEs|Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.|From birth until study termination|The analysis was done on the Safety Set.||Percentages of subjects|||Number
40734|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)|Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician’s visit, AEs leading to withdrawal are reported.|All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician’s visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.|The analysis was done on the Safety Set.||Percentages of subjects|||Number
40735|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.|From day 1 to 7 after vaccination|The analysis was done on the Safety Set, ie, all subjects in the enrolled population who received a study vaccination, provided post vaccination safety data, provided post-baseline safety data.||Percentages of subjects|||Number
40736|NCT01446289|Secondary|Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization|Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.|1 month after the last routine infant immunization|The analysis was done on the Immunogenicity PPS.||Percentages of subjects||95% Confidence Interval|Number
40737|NCT01446289|Secondary|GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth|GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.|Day 91 after birth|The analysis was done on the Immunogenicity PPS.||Ratio||95% Confidence Interval|Geometric Mean
40738|NCT01446289|Secondary|GMC (ELISA) of Anti-GBS CPS Antibodies in Infants|GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.|Day of birth and day 91 after birth|The analysis was done on the Immunogenicity PPS.||μg/mL||95% Confidence Interval|Geometric Mean
40739|NCT01446289|Secondary|Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects|GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.|Day 31, day of delivery, day 91 post-delivery|The analysis was done on the Immunogenicity PPS.||Ratio|Participants|95% Confidence Interval|Geometric Mean
40740|NCT01446289|Secondary|GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects|GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.|Day 1, day 31 and day 91 post-delivery|The analysis was done on the Immunogenicity PPS.||µg/mL||95% Confidence Interval|Geometric Mean
40741|NCT01446289|Primary|Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery|The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|The analysis was done on the Immunogenicity PPS.||Ratio||95% Confidence Interval|Geometric Mean
40742|NCT01446289|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth|GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|The analysis was done on the Immunogenicity Per Protocol Set (PPS), ie: all subjects in the enrolled population who correctly received the vaccine, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to un-blinding.||µg/mL||95% Confidence Interval|Geometric Mean
40743|NCT01446250|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.|24 weeks post-treatment|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.|||||
40744|NCT01446250|Secondary|Percentage of Participants With Emergence of Resistant Mutations||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.|||||
40754|NCT01445951|Secondary|FPG Change From Baseline to Week 24|Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)|Baseline to Week 24|Full analysis set||mg/dL||Standard Error|Least Squares Mean
40755|NCT01445951|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Safety population||Liters||Standard Error|Least Squares Mean
40756|NCT01445951|Primary|Change From Baseline to Week 24 in HbA1c|Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24|Baseline to Week 24|Full analysis set||Percent of hemoglobin||Standard Error|Least Squares Mean
40757|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy|Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.||participants|||Number
40758|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation|Number of participants who received an heart/lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.||participants|||Number
40759|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation|Number of participants who received an lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.||participants|||Number
40760|NCT01445873|Secondary|Number of Hospitalizations|All hospitalizations during the follow-up period recorded in medical records.|Day 1 to Month 6|FAS||hospitalizations||95% Confidence Interval|Mean
40761|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality|Number of participants who died during the follow-up period.|Day 1 to Month 6|FAS||participants|||Number
40762|NCT01445873|Secondary|Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening|Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class.|Day 1 to Month 6|FAS||months||Standard Deviation|Mean
40763|NCT01445873|Secondary|Change From Baseline in Percent of Predicted Peak VO2|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.||percent Vo2||95% Confidence Interval|Mean
40764|NCT01445873|Secondary|Change From Baseline in Borg Dyspnoea Score|Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum). Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.||units on a scale||95% Confidence Interval|Mean
40765|NCT01445873|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)|6MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and 1 value recorded during follow-up period.||meters||95% Confidence Interval|Mean
40766|NCT01445873|Secondary|Change From Baseline in Tricuspid Regurgitant Velocity|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.||m/sec||95% Confidence Interval|Mean
40767|NCT01445873|Secondary|Change From Baseline in Tei Index|Difference between pre-index and follow-up value. Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.||ratio||95% Confidence Interval|Mean
40768|NCT01445873|Secondary|Change From Baseline in Cardiac Output|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.||L/min||95% Confidence Interval|Mean
40769|NCT01445873|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.||Dyn/s/cm5||95% Confidence Interval|Mean
40770|NCT01445873|Secondary|Change From Baseline in Left Ventricular End Diastolic Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values for this outcome measure.||mm Hg||95% Confidence Interval|Mean
40771|NCT01445873|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up values.||mm Hg||95% Confidence Interval|Mean
40772|NCT01445873|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values reported for this outcome measure.||mm Hg||95% Confidence Interval|Mean
40773|NCT01445873|Secondary|Change From Baseline in Mean Right Atrial Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 value recorded during follow-up period.||mm Hg||95% Confidence Interval|Mean
40774|NCT01445873|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension|Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.|Baseline to Month 6|FAS; N=number of participants with pre-index (prior to Thelin initiation) and ≥ 1 WHO value recorded during follow-up.||participants|||Number
40776|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage|Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.|Day 1 to Month 6|FAS||mg||95% Confidence Interval|Mean
40777|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed|Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.|Day 1 to Month 6|Not analyzed: duration of Thelin therapy as number of therapy days dispensed was not summarized; this measure was reported as duration in months only.||days||Standard Deviation|Mean
40778|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration|Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.|Day 1 to Month 6|FAS; participants without evidence of discontinuation of Thelin therapy were censored at the end of follow-up (at 6 months or death if prior to 6 months).||months||Standard Deviation|Mean
40779|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation|Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.|Day 1 to Month 6|FAS||participants|||Number
40780|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching|Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.|Day 1 to Month 6|FAS||participants|||Number
40781|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation|Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.|Day 1 to Month 6|Full analysis set (FAS): participants with idiopathic pulmonary arterial hypertension (PAH) or PAH secondary to connective tissue disease, receipt of Thelin for treatment of PAH, 6 months of follow-up (except for death) after initial receipt (IR) of Thelin, and at least 1 clinic visit in medical record during 6-month period after IR of Thelin.||months||Standard Deviation|Mean
40782|NCT01445847|Primary|Number of Patients With Laryngospasm Postoperatively|"There were 4 scores of laryngospasm:~0 = No Laryngospasm~= Stridor or partial laryngospasm~= Complete Laryngospasm~= Cyanosis"|within first 15 minutes post‐dose|Trial was terminated by data monitoring committee due to safety concerns||participants|||Number
40783|NCT01445769|Other Pre-specified|Dose Distribution at Week 24|Average Daily Dose for the last 28 days on study.|Week 24|Intent-to-treat population: All enrolled participants.||participants|||Number
40784|NCT01445769|Secondary|Number of Participants With Grade 3 or Grade 4 Adverse Events||Baseline to the end of the study|Safety population: All participants who took at least 1 dose of study drug.||participants|||Number
40785|NCT01445769|Secondary|Median Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]).|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Full Range|Median
40786|NCT01445769|Secondary|Mean Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]), each on a scale of 0 to 10. A higher score indicates worse symptoms. A negative change score indicates improvement. The Baseline abdominal symptom score was the mean of daily abdominal symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 30. The Week 24 abdominal symptom score was the mean of the daily abdominal symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 30.|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Standard Deviation|Mean
40787|NCT01445769|Secondary|Percentage of Participants With Clinically Notable Anemia|Clinically Notable Anemia was a pre-specified safety parameter examined at Weeks 12, 18 and 24 and defined as: 1) New onset Grade 3 or higher anemia in subjects who are transfusion independent at Baseline, 2) New onset transfusion dependence in subjects who are transfusion independent at Baseline, defined as receipt of ≥ 2 units in ≤ a 12-week interval, 3) 50% increase in transfusions compared to Baseline in subjects who are transfusion dependent at Baseline.|Baseline to Weeks 12, 18 and 24|Safety population: All participants who took at least 1 dose of study drug.||Percentage of participants|||Number
40788|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Their Transfusion Status or With New Transfusion Independence Status for Those Participants Who Were Transfusion Dependent at Baseline|"Transfusion dependence at Baseline is defined as subjects who received ≥ 2 units of red blood cell product(s) in the 12 consecutive weeks prior to the date of first dose.~Transfusion independence On-Study is defined as subjects who received 0 units of red blood cell products over any 12-week period after starting dosing with ruxolitinib.~Improvement in transfusion dependence On-Study is defined as a 50% or greater reduction in the frequency of red blood cell transfusions over any 12-week period after starting dosing with ruxolitinib."|Baseline to Week 24|Intent-to-treat population: All enrolled participants who were transfusion dependent at baseline (n=15).||Percentage of participants||95% Confidence Interval|Number
40808|NCT01445626|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.||µm||Standard Deviation|Mean
40789|NCT01445769|Secondary|Median Percent Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.||Percentage change||Full Range|Median
40790|NCT01445769|Secondary|Mean Percentage Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.||Percentage change||Standard Deviation|Mean
40791|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
40792|NCT01445769|Secondary|Percentage of Participants With a ≥ 10% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
40793|NCT01445769|Secondary|Percentage of Participants With a ≥ 35% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
40794|NCT01445769|Secondary|Median Percent Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily TSS was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Full Range|Median
40795|NCT01445769|Secondary|Mean Percentage Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0). Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score (TSS) was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline TSS was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 TSS was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.||Percentage change||Standard Deviation|Mean
40809|NCT01445626|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.||Percentage of participants|||Number
40796|NCT01445769|Primary|Median Percent Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.||: Percentage change||Full Range|Median
40797|NCT01445769|Primary|Mean Percentage Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.||Percentage change||Standard Deviation|Mean
40798|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit|LFU; 38 to 45 days after first study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.||percentage of subjects|||Number
40799|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit.|LFU; 38 to 45 days after first study drug administration|MITT: Randomized patients, with baseline pathogen.||percentage of subjects|||Number
40800|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.||percentage of subjects|||Number
40801|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|MITT: Microbiological Intent-to-Treat: Randomized patients, with baseline pathogen.||percentage of subjects|||Number
40802|NCT01445678|Secondary|The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population|Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen|TOC; 26-30 days after start of study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.||percentage of subjects|||Number
40803|NCT01445678|Primary|The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population|Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|TOC; 26-30 days after start of study drug administration|MITT: Randomized patients, with baseline pathogen.||percentage of subjects|||Number
40804|NCT01445652|Primary|Subjective Vision With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.||Units on a scale||Standard Deviation|Mean
40805|NCT01445652|Primary|Subjective Happiness With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.||Units on a Scale||Standard Deviation|Mean
40806|NCT01445626|Secondary|Time to Improvement of 3 Lines or More in BCVA|Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.||Days||Full Range|Median
40807|NCT01445626|Secondary|Time to Improvement of 2 Lines or More in BCVA|Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.||Days||Full Range|Median
40810|NCT01445626|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.||Percentage of participants|||Number
40811|NCT01445626|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.||Letters||Standard Deviation|Mean
40812|NCT01445626|Primary|Time to OZURDEX® Re-injection|Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.|Up to 12 months|All participants with data available for analysis.||Days||Standard Deviation|Mean
40813|NCT01445613|Secondary|Clinical Success|Clinical success is defined as the attainment of < 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.|30 days|FAS population||percentage of participants||95% Confidence Interval|Number
40814|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|365 days|FAS population||percentage of participants|||Number
40815|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|180 days|FAS population||percentage of participants|||Number
40816|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|30 days|FAS population||percentage of participants|||Number
40817|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age||365 days|FAS population||percentage of participants|||Number
40818|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Age||30 days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.||percentage of participants||95% Confidence Interval|Number
40819|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status||365 days|FAS population||percentage of participants|||Number
40820|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Symptomatic Status||30 days|FAS population||percentage of participants||95% Confidence Interval|Number
40821|NCT01445613|Primary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days||365 days|FAS population||percentage of participants|||Number
40822|NCT01445613|Secondary|Death and All Stroke||30 Days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.||percentage of participants||95% Confidence Interval|Number
40823|NCT01445613|Primary|Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)||0 to 365 days|FAS population||percentage of participants||Standard Error|Mean
40824|NCT01445548|Secondary|Development of Exudative Age-Related Macular Degeneration (AMD) as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline||Baseline and 12 Months||||||
40825|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio|Participants|Standard Deviation|Mean
40826|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio|Participants|Standard Deviation|Mean
40827|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio|Participants|Standard Deviation|Mean
40895|NCT01444391|Primary|Number of Subjects With Procedural, Serious and Device-related Adverse Events.|Adverse events which are procedural, serious, and device-related.|Procedure through 2 weeks post-procedure|||subjects|||Number
40896|NCT01444300|Secondary|Change in Timed 25 Foot Walking Speed||Baseline to 12 weeks|||seconds||Standard Deviation|Mean
41352|NCT01438814|Secondary|Change From Baseline in Body Weight by Visit at Week 14|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight|Baseline and 14 weeks|FAS1000 having values for weight at baseline and week 14.||kg||Standard Error|Mean
40828|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|||Ratio|Participants|Standard Deviation|Mean
40829|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss.The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
40830|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
40831|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
40832|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
40833|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.||MPS DA|Participants|Standard Deviation|Mean
40834|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.||MPS DA|Participants|Standard Deviation|Mean
40835|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|||Ratio||Standard Deviation|Mean
40836|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||Ratio||Standard Deviation|Mean
40902|NCT01444287|Primary|Corneal Thickness|Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.|After 8 hours of contact lens wear|Subjects are those enrolled and randomized to a trial arm.||Percent Change||Standard Error|Least Squares Mean
40837|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
40838|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2|Participants|Standard Deviation|Mean
40839|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||ETDRS letters|Participants|Standard Deviation|Mean
40840|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||ETDRS letters|Participants|Standard Deviation|Mean
40841|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2/month|Participants|Standard Deviation|Mean
40842|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.||mm^2/month|Participants|Standard Deviation|Mean
40843|NCT01444924|Secondary|Pain Scores|Pain scores by the Visual Analog Scale (VAS) and Wisconsin Brief Pain Inventory (BPI), collected once the day of surgery (at least 2 hours post-op), and both the morning and afternoon/evening on post-operative day #1.|2 days||||||
40844|NCT01444924|Primary|24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents||24 hours|||mg||Standard Deviation|Mean
40845|NCT01444898|Primary|Appetite Scores|"Appetite scores using a syndrome-validated hyperphagia questionnaire~11 item questionnaire divided into subcategories of behavior (5 questions), drive (4 questions), severity (2 questions). Tallied and analyzed as total and subcategory scores. Each question scored 1-5 with higher scores correlating with worse hyperphagia.~Possible ranges: Total 11-55, behavior 5-25, drive 4-20, severity 2-10"|6 months|||units on a scale||Standard Deviation|Mean
40846|NCT01444898|Primary|Change in Pancreatic Peptide (PP)||6 months|||pg ml^-1||Standard Deviation|Mean
40847|NCT01444898|Primary|Change in Acy Ghr||6 months|||pg ml^-1||Standard Deviation|Mean
40848|NCT01444898|Primary|Change in Leptin||6 months|||ng ml^-1||Standard Deviation|Mean
40849|NCT01444898|Primary|Change in Insulin Levels||6 months|||u/U ml^-1||Standard Deviation|Mean
40850|NCT01444898|Primary|Change in HbA1c (%)||6 months|||percentage||Standard Deviation|Mean
40851|NCT01444898|Primary|Change in BMI Z-Score||6 months|||units on a scale||Standard Deviation|Mean
40852|NCT01444898|Primary|% Change in Body Mass Index (BMI)|Prior to analysis, distributions were evaluated for normality and natural log transformation was performed to analyse data not normally distributed. Data are presented as mean ±SD unless not normally distributed, in which case they are presented as median with intra-quartile ranges (25th and 75th percentiles). Within-subject changes between visits were analysed by mixed model repeated measures. When the overall F-test for difference among visits was significant, Dunnett-adjusted pairwise comparisons were made between baseline and each subsequent visit.|6 months|||% change in BMI||Standard Deviation|Mean
40853|NCT01444898|Primary|Change in Weight|Change in weight (kg) after 6 months of treatment with study drug. Described as mean +/- SD|6 months|||kg||Standard Deviation|Mean
40854|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions were assessed in the Safety Analysis Set.||Participants|||Number
40901|NCT01444287|Primary|Endothelial Blebs|Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).|baseline, after 20 minutes of treatment conditions|||percentage of bleb area||Standard Error|Mean
40855|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received the study or control vaccine.||Participants|||Number
40856|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.|Day 30 after final booster vaccination|Geometric mean titers to vaccine antigens were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
40857|NCT01444781|Secondary|Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata|Anti-PT and anti-FHA antibodies were measured by ELISA.|Day 0 (pre-vaccination) and Day 30 after final booster vaccination|Booster responses to vaccine antigens were assessed in the Per Protocol Analysis Set.||Participants|||Number
40858|NCT01444781|Secondary|Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.|Day 30 after final booster vaccination|Geometric mean titers against Prevenar vaccine serotypes were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
40859|NCT01444781|Secondary|Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.|Day 30 after final booster vaccination|Antibody responses against Prevenar vaccine serotypes were assessed in the Per-protocol Analysis Set.||Participants|||Number
40860|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.|"Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker).~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Geometric mean titers against vaccine antibodies were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
40861|NCT01444781|Primary|Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.||Participants|||Number
40862|NCT01444781|Primary|Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.||Participants|||Number
40863|NCT01444781|Primary|Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per-protocol Analysis Set.||Participants|||Number
40897|NCT01444300|Secondary|Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores|The ABC is an 11-point scale and subjects are asked to indicate personal level of confidence in doing specific activities without losing balance or becoming unsteady on a scale from 0% to 100%. The ratings are added (possible range =0 -1600) and divide by 16 to get each subject's ABC score. A high ABC score indicates a high degree of confidence and a low ABC score indicates a low degree of confidence.|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
40864|NCT01444781|Primary|Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine|"Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers"|Day 140 (Primary series) and Day 0 (Pre-booster)|Antibody responses were assessed in the Per Protocol Analysis Set, which includes all persons who did not have any protocol deviations.||Participants|||Number
40865|NCT01444651|Secondary|Baseline to 3-month Change in Matsuda Disposition Index|Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = [Matsuda sensitivity index * insulinogenic index]|Baseline and 3 months|||unitless index||Standard Deviation|Mean
40866|NCT01444651|Secondary|Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index|The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin|Baseline and 3 months|||unitless index||Standard Deviation|Mean
40867|NCT01444651|Secondary|Insulinogenic Index|The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = [fasting insulin - insulin at time 30 min] / [fasting glucose - glucose at time 30 min]|Baseline and 3 months|||unitless index||Standard Deviation|Mean
40868|NCT01444651|Secondary|Baseline to 3-month Change in Endothelial Function Measured by EndoPAT|Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)|Baseline and 3 months|||unitless index||Standard Deviation|Mean
40869|NCT01444651|Secondary|Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index|The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT [fasting glucose*fasting insulin* (mean glucose from time 30, 60, 90, 120 min) * (mean insulin at time 30, 60, 90, and 120 min)]|Baseline and 3 months|||unitless index||Standard Deviation|Mean
40870|NCT01444651|Primary|Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR|The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = [fasting glucose * fasting insulin]/405|Baseline and 3 months|||mg*microunits/dL*mL||Standard Deviation|Mean
40871|NCT01444456|Secondary|Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time|The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).|From Baseline to Week 13|Primary analysis set||percentage of participants|||Number
40872|NCT01444456|Secondary|Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time|The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|From Baseline to Week 13|Primary analysis set||percentage of participants|||Number
40873|NCT01444456|Secondary|Time to First Increase in Hemoglobin|Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL|From Baseline until Week 9|Primary analysis set||days||95% Confidence Interval|Median
40874|NCT01444456|Secondary|Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points|The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline and Week 9|Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline||units on a scale||Standard Deviation|Mean
40898|NCT01444300|Primary|Change in Automatic Postural Response (APR )Latency|Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of ~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects.|Baseline to 12 weeks|||milliseconds||Standard Deviation|Mean
40875|NCT01444456|Secondary|Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline to Week 9|Primary analysis set||percentage of participants||95% Confidence Interval|Number
40876|NCT01444456|Primary|Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.|The Primary analysis set consists of enrolled participants who received at least 1 dose of darbepoetin alfa, have baseline assessments for each of Hemoglobin, FACT-F subscale and VAS, and analyzable post-baseline assessments for each of Hemoglobin, FACT-F subscale, and VAS at Week 9.||percentage of participants||95% Confidence Interval|Number
40877|NCT01444430|Secondary|Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation|Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.||Participants|||Number
40878|NCT01444430|Secondary|Percent of Nights With Awakening(s) Due to Asthma|Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.||Percentage of nights||Standard Error|Least Squares Mean
40879|NCT01444430|Secondary|Asthma Control Questionnaire (ACQ6)|"The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide.~The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions."|baseline, day 28, day 84, day 182|Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score.||ACQ6 overall score change from baseline||Standard Error|Least Squares Mean
40880|NCT01444430|Secondary|Mean Number of Puffs of Rescue Medication Per 24 Hours|Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.||Inhalations/day||Standard Error|Least Squares Mean
40881|NCT01444430|Secondary|Percent of Days With Activity Limitation Due to Asthma|Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms.||Percentage of days||Standard Error|Least Squares Mean
40882|NCT01444430|Secondary|Percent of Days With no Asthma Symptoms|Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.||Percentage of days||Standard Error|Least Squares Mean
40899|NCT01444287|Secondary|Overall Comfort|Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).|after 8 hours|||units on a scale||Standard Error|Least Squares Mean
40900|NCT01444287|Primary|Limbal Redness|Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.|Baseline, After 8 hours of treatment conditions|||units on a scale||Standard Error|Least Squares Mean
40883|NCT01444430|Primary|Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation|Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.||Participants|||Number
40884|NCT01444430|Primary|Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)|Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 27 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug.||Participants|||Number
40885|NCT01444417|Secondary|Number of Participants With Adverse Events|"A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal,~life threatening (places the subject at immediate risk of death),~requires in-patient hospitalization or prolongation of existing hospitalization,~results in persistent or significant disability/incapacity,~congenital anomaly/birth defect, and/or~other significant medical hazard. Adverse events were graded for severity according to the CTCAE version 3.0 grading scale, where Grade 3 = moderate, Grade 4 = life-threatening and Grade 5 = fatal.~Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to study drug. This relationship was determined by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by study drug?”"|From the first dose of study drug until 4 weeks after last dose; 28 weeks.|Safety analysis set (all participants who received at least one dose of study drug)||participants|||Number
40886|NCT01444417|Secondary|Total Number of Composite Bleeding Episodes|A composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.|Week 2 to week 25|Efficacy analysis set||bleeding episodes||Standard Deviation|Mean
40887|NCT01444417|Secondary|Percentage of Participants Who Received Rescue Medication During the Treatment Period|Rescue medication is any medication (other than excluded medications) that is intended to increase platelet counts or prevent bleeding.|24 weeks|Efficacy analysis set||percentage of participants||95% Confidence Interval|Number
40888|NCT01444417|Secondary|Number of Weeks With Platelet Response|Number of weeks with platelet counts ≥ 50 x 10^9/L during week 2 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.|Week 2 to week 25|Efficacy analysis set||weeks||Full Range|Median
40889|NCT01444417|Secondary|Percentage of Participants With an Overall Platelet Response|"Overall platelet response is defined as either a durable platelet response or transient platelet response.~Durable platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 6 or more times during week 18 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medication.~Transient platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 4 or more times during week 2 to week 25 measurements but without durable platelet response. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications."|Week 2 to week 25|Efficacy analysis set||percentage of participants||95% Confidence Interval|Number
40890|NCT01444417|Primary|Percentage of Participants With a Durable Platelet Response|A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10^9/L during the last 8 weeks of treatment (platelet counts obtained from week 18 to week 25). If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.|Week 18 to week 25|Efficacy analysis set (all randomized participants)||percentage of participants||95% Confidence Interval|Number
40891|NCT01444391|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post-procedure|"This outcome measure analysis includes evaluation only of ears with TDS-placed tube.~Two subjects (3 ears) were excluded due to missing follow-up data. An additional 3 subjects (4 ears) were excluded because no TDS tube was placed. Three of the 37 participants analyzed had one of two study ears excluded, due to no TDS in that ear."||ears|Participants||Number
40892|NCT01444391|Secondary|Procedure Tolerability|Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient’s score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.|Day 0 (day of procedure)|The analysis population includes subjects with successful tube placement using the Tube Delivery System (TDS) in one or both ears. Six subjects were excluded for whom one ear had a successful TDS placement and one ear did not.||participants|||Number
40893|NCT01444391|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)|||participants|||Number
40894|NCT01444391|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)|||devices|Participants||Number
40906|NCT01443923|Secondary|Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
40907|NCT01443923|Secondary|Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment||End of Treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
40908|NCT01443923|Secondary|Safety and Treatment Outcome Measures Stratified by ESA Use||6 months|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
40909|NCT01443923|Secondary|Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects||Day 0, Day 7|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
40910|NCT01443923|Primary|Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.|||||
40911|NCT01443858|Secondary|Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 3 (Session P3) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 3 weeks of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"||percentage change||Standard Error|Mean
40912|NCT01443858|Secondary|Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 1 (Session P2) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 1 week of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"||percentage change||Standard Error|Mean
40913|NCT01443858|Secondary|Number of Participants Completing the Continuous 4 Week Abstinence From Smoking|Continuous 4 week abstinence from smoking (weeks 3-6 post quit date), based on self-reported abstinence confirmed by expired air CO ≤8ppm, will be compared between each meclizine group and placebo, using logistic regression analyses|weeks 3-6 post quit date|||participants||95% Confidence Interval|Number
40914|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3|To evaluate the effects of meclizine as an augmentation treatment in conjunction with nicotine patch, the percent decrease in expired air carbon monoxide (CO) at the end of week 3 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 3 weeks of treatment (relative to baseline)|||percentage change||Standard Error|Mean
40915|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1|To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 1 week of treatment (relative to baseline)|||percentage change||Standard Error|Mean
40916|NCT01443845|Secondary|Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)|Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)|Week 0 (Visit 2) to Week 52|Intent-to-Treat Population who the completed 52-week treatment period||Liters||Standard Error|Least Squares Mean
40917|NCT01443845|Secondary|Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics|Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.|Week 0 (Visit 2) to Week 52|||COPD Exacerbations per Patient per Year||95% Confidence Interval|Number
40918|NCT01443845|Secondary|Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)|Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Week 0 (Visit 2) to Week 52|Intent-to-Treat Study Population||COPD exacerbations per patient per year||95% Confidence Interval|Number
40919|NCT01443845|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.|Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Baseline to Week 52|Intent-to-Treat Study Population||COPD exacerbations per patient per year||95% Confidence Interval|Number
40920|NCT01443494|Secondary|Perfused Vessel Density|Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by SDF, including the parameters of perfused vessel density|Target MAP stabilization for 30 min|||vessels/mm^2||Standard Deviation|Mean
40921|NCT01443494|Primary|Mean Arterial Pressure|"As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients’ physical examination records of the last two years was registered and assumed as patients’ usual level of MAP and target MAP. If patients’ medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.~After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements."|Target MAP stabilization for 30 min|||mmHg||Standard Deviation|Mean
40922|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40923|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40924|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40925|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40926|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40927|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40928|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40929|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40930|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40931|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40932|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40933|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40934|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 2|||units on a scale||Full Range|Median
40935|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40936|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40937|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40938|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40939|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40940|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40941|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40942|NCT01443364|Secondary|Bone Erosion at Week 0|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40943|NCT01443364|Secondary|Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40944|NCT01443364|Secondary|Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40945|NCT01443364|Secondary|Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40946|NCT01443364|Secondary|Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40947|NCT01443364|Secondary|Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40948|NCT01443364|Secondary|Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40949|NCT01443364|Secondary|Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40950|NCT01443364|Secondary|Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40951|NCT01443364|Secondary|Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40952|NCT01443364|Secondary|Cartilage Damage at Week 0|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40953|NCT01443364|Secondary|Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40954|NCT01443364|Secondary|Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40955|NCT01443364|Secondary|Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40956|NCT01443364|Secondary|Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40957|NCT01443364|Secondary|Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40958|NCT01443364|Secondary|Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40959|NCT01443364|Secondary|Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40960|NCT01443364|Secondary|Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41099|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set||percentage of participants|||Number
40961|NCT01443364|Secondary|Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40962|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 0|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40963|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40964|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40965|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40966|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40967|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40968|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40969|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40970|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40971|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40972|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 0|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40973|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40974|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40975|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40976|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40977|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40978|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40979|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40980|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40981|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40982|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40983|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40984|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40985|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40986|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41100|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set||percentage of participants|||Number
40987|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40988|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40989|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40990|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40991|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40992|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40993|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40994|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40995|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40996|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40997|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40998|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
40999|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41000|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41001|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41002|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41003|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41004|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41005|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41006|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41007|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41008|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41009|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41010|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41011|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41012|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41013|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41014|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41015|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41016|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41017|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41018|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41019|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41020|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41021|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41022|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41023|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41024|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41025|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41026|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41027|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41028|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41029|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41030|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41031|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41032|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41033|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41034|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41035|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).||units on a scale||Full Range|Median
41117|NCT01441765|Secondary|Effect on Circulating Regulatory T Cells|To evaluate the effect of CT-011 alone or in conjunction with DC/RCC fusions on circulating regulatory T cells and PD-1 expression by circulating and bone marrow derived T cells.|2 years|Data was not analyzed as so few participants were enrolled and no participants achieved a PR.|||||
41036|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 1 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
41037|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 2 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
41038|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 4 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
41039|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 6 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
41040|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 8 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
41041|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 12 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.||percentage of subjects||95% Confidence Interval|Number
41042|NCT01443130|Secondary|Incidence of Infection in the Fetal Circulation|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants with cord blood smears and cord PCR results obtained.||percentage of participants||97.5% Confidence Interval|Number
41043|NCT01443130|Secondary|Incidence of Clinical Malaria, All Species|Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.||percentage of participants||97.5% Confidence Interval|Number
41044|NCT01443130|Secondary|Incidence of Malaria Infection, All Species.|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.||percentage of participants||97.5% Confidence Interval|Number
41045|NCT01443130|Secondary|Incidence of Active Placental Malaria Infection|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR).|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all maternal subjects with placental slides reviewed and PCR results obtained.||percentage of participants||97.5% Confidence Interval|Number
41046|NCT01443130|Secondary|Incidence of Intrauterine Growth Restriction (IUGR)|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar.|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery.||percentage of participants||97.5% Confidence Interval|Number
41047|NCT01443130|Secondary|Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all infants born alive with weight data collected at birth.||percentage of infants||97.5% Confidence Interval|Number
41048|NCT01443130|Secondary|Infant Mortality Rate to 14 Weeks of Age|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery.|For 14 weeks after delivery.|The analysis population includes all enrolled infants.||percentage of infants||97.5% Confidence Interval|Number
41049|NCT01443130|Secondary|Incidence of Preterm Delivery|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.||percentage of deliveries||97.5% Confidence Interval|Number
41050|NCT01443130|Secondary|Incidence of Miscarriage|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants.||percentage of pregnancies||97.5% Confidence Interval|Number
41051|NCT01443130|Secondary|Incidence of Stillbirth|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.||percentage of deliveries||97.5% Confidence Interval|Number
41052|NCT01443130|Secondary|Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl.|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.||percentage of maternal participants||97.5% Confidence Interval|Number
41053|NCT01443130|Secondary|Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL).|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.||percentage of maternal participants||97.5% Confidence Interval|Number
41054|NCT01443130|Secondary|Incidence of Placental Malaria by Placental Impression Smear|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed.||percentage of placentas||97.5% Confidence Interval|Number
41055|NCT01443130|Primary|Incidence of Placental Malaria Infection Based on Histology|The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue.|At delivery: Approximately 12-36 weeks after enrollment|All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis.||percentage of pregnancies||97.5% Confidence Interval|Number
41056|NCT01443078|Secondary|Overall Response Rate|"(FDG PET and CT), rate of pathologic down-staging, rate of pathologic response, and stage-specific disease free and overall survival in patients with resectable Stage Ib-IIIa non-squamous, NSCLC treated with neoadjuvant pemetrexed + cisplatin"|2 years||||||
41057|NCT01443078|Primary|PERCIST Partial Metabolic Response|"The primary endpoint was partial metabolic response after 2 cycles of switch therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline)."|2 years|||participants|||Number
41058|NCT01443026|Primary|Changes in Serum Biomarkers|Change in serum lycopene, umol/L|baseline and 6 months|||umol/L||Full Range|Mean
41059|NCT01443026|Secondary|Changes in Nuclear Morphometry|We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.|baseline and 6 months||||||
41060|NCT01443026|Primary|Tissue Biomarkers|We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.|baseline and 6 months||||||
41061|NCT01442844|Primary|Percentage of Wound Re-epithelialization||4 weeks|||percentage of wound re-epithelialization||Full Range|Mean
41062|NCT01442779|Secondary|Participants With Change in Cough|changes in cough status after treatment for 1 month.|1 month|During the course of the study it was noted that subjects experienced a change in the cough that is sometimes associated with IPF. The 6 subjects still enrolled in the study were asked to complete a questionnare regarding the status of the cough.||Participants|||Number
41063|NCT01442779|Primary|Minimal/no Change in Quality of Life||12 months|Analysis was performed only on those subject who continue on medication for at least one year.||Participants|||Number
41064|NCT01442779|Primary|Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function|Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects.|1 yr|||Participants|||Number
41065|NCT01442688|Primary|Maximum Plasma Concentration (Cmax) for Amoxicillin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set||ug/ml||Standard Deviation|Mean
41066|NCT01442688|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|The Pharmacokinetic Analysis Set was defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||h*ug/ml||Standard Deviation|Mean
41067|NCT01442675|Secondary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
41068|NCT01442675|Secondary|Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point.||Titers ratio||95% Confidence Interval|Geometric Mean
41069|NCT01442675|Secondary|Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point.||Titers||95% Confidence Interval|Geometric Mean
41070|NCT01442675|Secondary|Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.||Participants|||Number
41071|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).~Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.||Participants|||Number
41072|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).~Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.||Participants|||Number
41073|NCT01442675|Primary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)|Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set.||Participants|||Number
41074|NCT01442376|Secondary|Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from >24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle.|from >24 to 120 hours (delayed phase) after T0|Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
41075|NCT01442376|Primary|Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy.|0 to 24 hours after T0|Full Analysis Set (FAS) population||percentage of patients||95% Confidence Interval|Number
41076|NCT01442181|Other Pre-specified|Directed Fluency, Animals|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many animals as possible beginning with a letter, for one minute.|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||animals||Standard Deviation|Mean
41101|NCT01442038|Primary|Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization|Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set: all participants in the Safety Analysis Set (randomized and received at least one dose of study drug), except participants with no qualifying percutaneous coronary intervention (PCI; formerly known as angioplasty with stent))||percentage of participants|||Number
41077|NCT01442181|Other Pre-specified|Stroop Word Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop word test, and only 6 patients in the medical therapy group completed the stroop word test.~In this test, subjects are asked to read a list of words. 100 is the maximum amount of correct responses per trial."|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
41078|NCT01442181|Other Pre-specified|Wtar (Wechsler Test of Adult Reading) Word List|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).~The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete. The examiner begins by presenting the first word card and prompting the patient for a single pronunciation of the word. This procedure continues through all 50 word cards and is discontinued if the patient provides 12 consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, with 50 as the maximum raw score."|Baseline|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
41079|NCT01442181|Other Pre-specified|Stroop Color Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop color test, and only 6 patients in the medical therapy group completed the stroop color test.~In this test, subjects are asked to read a list of color words. 100 is the maximum amount of correct responses per trial."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||colors||Standard Deviation|Mean
41080|NCT01442181|Other Pre-specified|Hopkins Verbal Learning Test Version A|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). This test measures word recognition. 12 words are read to the subject and they have to repeat as many as they can recall. There are 4 trials, each with 12 total possible words.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
41081|NCT01442181|Other Pre-specified|Directed Fluency; Cowa (Controlled Oral Word Association Test)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many words as possible beginning with a letter, excluding proper nouns, for one minute and this procedure is repeated three times.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||words||Standard Deviation|Mean
41082|NCT01442181|Other Pre-specified|Montreal Cognitive Assessment (Moca)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The score is 0 - 30 point test with the higher the score the better cognitive function.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
41083|NCT01442181|Other Pre-specified|STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
41084|NCT01442181|Other Pre-specified|STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
41085|NCT01442181|Primary|Quality of Life RAND 36-Item Health Survey|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).~The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores which will have a 0 to 100 range."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.||units on a scale||Standard Deviation|Mean
41116|NCT01441765|Secondary|Number of Participants Who Survived at 2 Years|To evaluate overall survival following treatment with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.|2 years|||participants|||Number
41086|NCT01442155|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 3 years|Safety population included all participants treated with at least one dose of study drug.||percentage of participants|||Number
41087|NCT01442155|Primary|Disease-Free Survival (Time to Event)|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).|Up to 3 years|Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy.||months||95% Confidence Interval|Median
41088|NCT01442129|Secondary|Functional Status and Ventricular Function|"The key efficacy endpoint of this study is functional status and ventricular function, while weaned from LVAD support, at 90 days post intervention (LVAD implantation + intramyocardial injection of study product). Functional status is defined by the ability to tolerate wean from LVAD support for 30 minutes without signs or symptoms of hypoperfusion, including, but not limited to symptoms of low output or signs of vascular congestion. Ventricular function will be assessed by transthoracic echocardiogram (TTE) in those patients able to be weaned for 30 minutes from LVAD support.~The number of participants who successfully tolerated the 30 minute wean from LVAD support at 90 days is reported."|90 days|||participants|||Number
41089|NCT01442129|Primary|Intervention Related Adverse Events|The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.|90 days|||events|||Number
41090|NCT01442103|Secondary|Pain Upon Application of Investigational Product.|VAS pain scale will be used to measuring pain at each dressing change.|4 weeks||||||
41091|NCT01442103|Secondary|Infection Assessment|Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.|4 weekks||||||
41092|NCT01442103|Primary|Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.|Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.|4 weeks|Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit.||participants|||Number
41093|NCT01442064|Secondary|Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)|"NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24.~Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836)."|Baseline (Day 0 of extension study), Months 12 and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||Scores on a scale||Standard Deviation|Mean
41094|NCT01442064|Secondary|Change From Baseline in Central Foveal Thickness at Month 6 and Month 12|Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.|Baseline (Day 0 of extension study), Months 6 and 12|"Enrolled participants for whom data was available for analyses at the given time-point as indicated by n in the categories. Observed data were used with no imputation."||µm||Standard Deviation|Mean
41095|NCT01442064|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA)|Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.|Baseline (Day 0 of extension study), Months 6, 12, 18, and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||letters||Standard Deviation|Mean
41096|NCT01442064|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.~Additional information about adverse events can be found in the adverse events section."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.||participants|||Number
41097|NCT01442064|Primary|Number of Participants With Ocular Adverse Events in the Study Eye|"Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.||participants|||Number
41098|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set||percentage of participants|||Number
41102|NCT01441973|Secondary|Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate|All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Participants|||Number
41103|NCT01441973|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality|Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Participants|||Number
41104|NCT01441973|Primary|Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow|Estimated using linear regression model, with baseline CD56^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56^dim cells (% chg from BL in M pro/% chg CD56^dim cs)|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).||% chg from BL in M pro/% chg CD56^dim cs||95% Confidence Interval|Number
41105|NCT01441973|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Participants|||Number
41106|NCT01441973|Secondary|Objective Response Rate (ORR)|ORR is defined by criteria of modified International Myeloma Working Group as the number of responders (those with stringent compete response [SCR], complete response [CR], very good partial response [VGPR], and partial response [PR])/number of participants in arm. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level <100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to <200 mg/24 hour.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug||Percentage of participants||90% Confidence Interval|Number
41107|NCT01441960|Secondary|Differences in Seizure Duration Between Compounds|Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.|Up to six weeks following inclusion|||Seconds||Standard Deviation|Mean
41108|NCT01441960|Secondary|Compound Specific Differences in Time to Recovery From Neuromuscular Blockade|The investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.|Up to six weeks following inclusion|||minutes||Standard Deviation|Mean
41109|NCT01441960|Primary|Optimal Dose of Neuromuscular Blocking Agent During ECT|The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.|Up to six weeks following inclusion|||mg.kg-1||95% Confidence Interval|Mean
41110|NCT01441843|Secondary|Somatic Symptoms and Complaints|Medical records are used to assess somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure somatic symptoms and complaints.|Baseline; first postoperative working day; 1 week after surgery||||||
41111|NCT01441843|Secondary|Depressive Mood|The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of depression.|baseline; 1 week after surgery||||||
41112|NCT01441843|Secondary|Aggression Regulation|The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of aggression|baseline; 1 week after surgery||||||
41113|NCT01441843|Secondary|Fatigue|The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of fatigue.|baseline; 1 week after surgery||||||
41114|NCT01441843|Secondary|Anxiety|The State-Trait Anxiety Inventory (STAI) is used to assess anxiety. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of anxiety.|baseline; after surgery but before discharge; 1 week after surgery||||||
41115|NCT01441843|Primary|Quality of Recovery Score|"The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery.~Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery."|Baseline; first postoperative working day; seventh postoperative day.|||scores on a scale||Standard Deviation|Mean
41118|NCT01441765|Secondary|Immunologic Response|To evaluate immunologic response directed against RCC and tumor specific antigens following therapy with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Immunologic response will be characterized as peak response post-therapy and ongoing response at 3 and 6 months following treatment.|2 years|Data was not analyzed as so few participants were enrolled and none of the participants achieved a PR or CR.|||||
41119|NCT01441765|Primary|Number of Participants With PR or CR at 2 Years|"To evaluate the complete and partial response rate following completing 4 cycles of CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, (with an absolute increase of at least 5 mm), or the appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|2 years|||participants|||Number
41120|NCT01441765|Primary|Number of Participants With Adverse Events|Assessment of toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction with DC/RCC. Toxicity was assessed and classified according to CTCAE Version 4.0.|2 years|||participants|||Number
41121|NCT01441596|Secondary|Overall Survival|Overall Survival is defined as time from randomisation to the date of death from any cause.|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who died||weeks||Inter-Quartile Range|Median
41122|NCT01441596|Secondary|Progression-Free Survival|"Progression-Free Survival is defined as the time from the date of randomisation to the date of disease progression or death whichever came first.~Disease progression was defined as either disease progression in CNS lesions (including worsening in NSS and use of corticosteroid) or disease progression in extra-CNS lesions according to RECIST 1.1."|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who experienced disease progression or death||weeks||Inter-Quartile Range|Median
41123|NCT01441596|Primary|Patient Benefit Rate at 12 Weeks|Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1|12 weeks from randomisation|Randomised Set (RS): includes all randomised patients, whether treated or not.||percentage of participants||95% Confidence Interval|Number
41124|NCT01441466|Secondary|Cross-infection|nosocomially acquired cross-infection|measured until 1 week after hospital exit|||participants|||Number
41125|NCT01441466|Secondary|Mechanical Ventilation|Mechanical ventilation and endotracheal intubation needed|duration of hospitalisation, an average of 3-4 days|||participants|||Number
41126|NCT01441466|Secondary|Highest Dyspnoea Score|highest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)|duration of hospitalisation, an average of 3-4 days|||units on a scale (0-10)||Standard Deviation|Mean
41127|NCT01441466|Secondary|Supplemental Oxygen Needed|number of days that supplemental oxygen was needed|duration of hospitalisation, an average of 3-4 days|||days||Standard Deviation|Mean
41128|NCT01441466|Secondary|Number of Days With Tube Feeding|number of days the patient has been tube fed|duration of hospitalisation, an average of 3-4 days|||days||Standard Deviation|Mean
41129|NCT01441466|Primary|Duration of Hospital Stay||duration of hospitalisation, an average of 3-4 days|||days||Standard Deviation|Mean
41130|NCT01441440|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
41131|NCT01441440|Secondary|Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
41132|NCT01441440|Secondary|Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination|HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
41167|NCT01441245|Primary|Evaluation of Renal Function in Terms of Creatinine Levels at Discharge||from admission to discharge, an average of 12 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.||mg/dL||Standard Deviation|Mean
41133|NCT01441440|Secondary|Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
41134|NCT01441440|Secondary|Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination|MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 – 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
41135|NCT01441440|Primary|Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.||Units on a scale||Standard Error|Mean
41136|NCT01441414|Secondary|Overall Survival (OS) at 2 Years|OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS.|5 years|This endpoint was not assessed due to the early termination of the study.|||||
41137|NCT01441414|Secondary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date – the date of randomization +1).|3 years|This endpoint of estimating median PFS was not assessed due to early termination of the study.|||||
41138|NCT01441414|Secondary|Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive|Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.|0 and 360 hours post dose and end of study|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||ADA samples|Participants||Number
41139|NCT01441414|Secondary|Cmin (Trough PF-04856884 Serum Concentration)|Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||ng/mL||Standard Deviation|Mean
41140|NCT01441414|Secondary|Cmax (Observed Peak Serum PF-04856884 Concentration)|Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||ng/mL||Standard Deviation|Mean
41141|NCT01441414|Secondary|Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)|Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||hr||Standard Deviation|Mean
41142|NCT01441414|Secondary|Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone|DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR − first CR or PR that is subsequently confirmed +1).|3 years|This endpoint was not assessed due to the early termination of the study.|||||
41143|NCT01441414|Secondary|Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.|ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||Percentage of participants|||Number
41144|NCT01441414|Secondary|Number of Participants With Non-serious AEs and SAEs|Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).|3 years|This endpoint was not assessed due to the early termination of the study.|||||
41145|NCT01441414|Primary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date – the date of randomization +1).|3 years|The primary efficacy endpoint of estimating median PFS in Part II was not assessed due to early termination of the study.|||||
41146|NCT01441414|Primary|Number of Participants With Serious Adverse Events (SAEs) in Part I|Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||participants|||Number
41147|NCT01441414|Primary|Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).|"Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below.~Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week)."|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.||participants|||Number
41148|NCT01441401|Other Pre-specified|Reduction From Baseline in Epileptic Seizure Frequency|Reduction from baseline in epileptic seizure frequency was defined by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: Reduction from baseline in epileptic seizure frequency (%) = [(T-B) / B] X 100. The median percentages were presented along with the corresponding minimum and maximum percentages.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.||Percentage||Full Range|Median
41149|NCT01441401|Other Pre-specified|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was – 0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of – 0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.||Percentage of participants||95% Confidence Interval|Number
41150|NCT01441401|Other Pre-specified|Response Ratio (R Ratio)|R Ratio was calculated by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: R Ratio = (T - B) / (T + B). R Ratio is within the range of -1 to +1, and a negative value represents a reduction in the frequency of seizure.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.||Ratio||Standard Deviation|Mean
41151|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)|Aggressive behaviors including affect lability and hostility were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined as the 101 preferred terms listed by pharmaceuticals and medical devices agency and classified according to MedDRA/J version 17.1. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
41152|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)|Central nervous system depressant actions including somnolence and ataxia were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined according to MedDRA/J version 17.1 as the events classified in “psychiatric disorders” or “nervous system disorders” of the system organ classes, or those classified in “asthenia” or “gait disturbance” of the preferred terms. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
41153|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period|Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term [less than 1 year] or long term [1 year or more]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
41154|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
41155|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 versus >8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
41156|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.||Participants|||Number
41157|NCT01441401|Secondary|Number of Participants With Risk Factors for Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by each candidate risk factor (including gender, age, and disease eligible for the survey) to assess whether these were risk factors for the treatment-related adverse events. No inferential analyses of risk factors were performed because of a small number of the events (5 events).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. No data displayed because outcome measure has zero total participants analyzed.|||||
41158|NCT01441401|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
41159|NCT01441401|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population from which those with data not assessable were excluded. n=number of participants with assessable data at each post-baseline time point.||Percentage of participants||95% Confidence Interval|Number
41160|NCT01441401|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||Participants|||Number
41161|NCT01441245|Secondary|Dopamine Infusion During Hospitalization||in-hospital|||percentage of partecipants|||Number
41162|NCT01441245|Primary|Evaluation of Renal Function in Terms of GFR Values at Discharge||from admission to discharge, an average of 12 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant||(ml/min·1.73 m2)||Standard Deviation|Mean
41163|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in GFR||from admission to discharge, an average of 12 days|||(ml/min·1.73 m2)||Standard Deviation|Mean
41164|NCT01441245|Primary|Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge||participants were followed for the duration of hospital stay, an average of 13 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.||pg/mL||Standard Deviation|Mean
41165|NCT01441245|Primary|Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment||from admission to discharge, an average of 12 days|||pg/ml||Standard Deviation|Mean
41166|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in Creatinine Levels|evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.|participants were followed for the duration of hospital stay, an average of 13 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.||mg/dL||Standard Deviation|Mean
41168|NCT01441245|Secondary|Length of Hospitalization in the Two Groups|percentage of participants with hospital stay > 10 days|in-hospital|Qualitative variables are expressed as percentage and compared with chi-square test . p values <0.05 were considered significant.||percentage of partecipants|||Number
41169|NCT01441245|Primary|Evaluation of Mean Urine Output Volume During the Infusion Period|this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge|time period ranging from 72 h to 120 h.|||mL||Standard Deviation|Mean
41170|NCT01441180|Primary|Sustained Virologic Response|Sustained virology response at 24 weeks post treatment completion|24 weeks post treatment completion|on protocol analysis||percentage of total participants||95% Confidence Interval|Number
41171|NCT01441180|Primary|Participants With Adverse Events|Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.|24 weeks|||partipants|||Number
41172|NCT01441102|Secondary|Number of Participants Withdrawn From the Study Therapy Due to Vision Loss or Adverse Events||Duration of the study, up to 24 months||||||
41173|NCT01441102|Secondary|Changes in Mean Macular Sensitivity at 24 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 24 Months||||||
41174|NCT01441102|Secondary|Changes in Mean Macular Sensitivity at 18 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 18 Months||||||
41175|NCT01441102|Secondary|Changes in Mean Macular Sensitivity at 12 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 12 Months||||||
41176|NCT01441102|Secondary|Changes in Mean Macular Sensitivity at 6 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 6 Months||||||
41177|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 24 Months||||||
41178|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 18 Months||||||
41179|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 12 Months||||||
41180|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 6 Months||||||
41181|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months||||||
41182|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months||||||
41183|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 12 Months||||||
41184|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Two participants withdrew from the study prior to the 6-month visit.||ETDRS letters|Participants|Standard Deviation|Mean
41185|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 24 Months||||||
47861|NCT01348139|Secondary|E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit|Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.|0 - 24 hrs|PD analysis set||Liters||Standard Deviation|Mean
41186|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 18 Months||||||
41187|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 12 Months||||||
41188|NCT01441102|Primary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 months|Two participants withdrew from the study prior to the 6-month visit.||percentage change in retinal thickness|Participants|Standard Deviation|Mean
41189|NCT01440972|Secondary|Change in Isokinetic Knee Extensor Strength||4 weeks|||Nm/kg||Standard Error|Least Squares Mean
41190|NCT01440972|Secondary|Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.|4 weeks|||units on a scale||Standard Deviation|Mean
41191|NCT01440972|Secondary|Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum||4 weeks|||Watts||Standard Deviation|Mean
41192|NCT01440972|Secondary|Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging||4 weeks|||Percent change||Standard Deviation|Mean
41193|NCT01440972|Primary|Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass||4 weeks|||kg per kg body mass||Standard Deviation|Mean
41194|NCT01440959|Secondary|Overall Survival|Overall survival duration is calculated as time from the first treatment to the date of death. For patients who are still alive at the cut‐off date for statistical reporting, the overall survival duration will be right censored on the last known alive date.|Up to 3 years|||months||95% Confidence Interval|Median
41195|NCT01440959|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Up to 3 years|||months||95% Confidence Interval|Median
41196|NCT01440959|Secondary|Number of Participants With Adverse Events|Adverse events will be graded according to Common Terminology Criteria for Adverse events version 3.0, up to 3 year.|Monitoring of adverse events will be continued for at least 28 days following the last dose of study treatment, up to 3 year.|||participants|||Number
41197|NCT01440959|Secondary|Efficacy According to the Concentrations of Circulating Growth Factors|Correlation between efficacy results, such as response, progression-free survival, and overall survival andcirculating growth factors (including vascular endothelial growth factor, fibroblast growth factor, interleukin‐8, placental growth factor, and fibroblast growth factor23), and soluble receptors (including soluble form of membrane bound vascular endothelial growth factor receptor-1 and -2).|Up to 24weeks||||||
41198|NCT01440959|Secondary|Efficacy According to the Primary Mutation Type|Correlation between efficacy results such as response, progression-free survival and overall survival, and primary mutation type including KIT exons 9, 11, 13, and 17 and PDGFRα exons 12 and 18.|Up to 24weeks||||||
41199|NCT01440959|Secondary|Overall Response Rate Using Both CT and PET Scans|PET scan will be performed at baseline and at 4 weeks of treatment. Metabolic response was defined based on the PET response criteria of the European Organization for Research and Treatment of Cancer (EORTC); a metabolic partial response (mPR) was defined as a 25% reduction in average SUVmax; metabolic stable disease (mSD) between a 25% decrease and 25% increase in average SUVmax; metabolic progressive disease (mPD) as a 25% increase in average SUVmax or the appearance of new uptake in metastatic lesions.|Up to 24 weeks|||Percentage of participants|||Number
41200|NCT01440959|Primary|Disease Control Rate (DCR; OR + Stable Disease)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD~This was evaluated with abdominal and pelvic dynamic CT scan every 4 weeks for the initial 8 weeks, and then every 8 weeks."|Up to 24 weeks|||Percentage of participants||95% Confidence Interval|Number
41228|NCT01440595|Secondary|Number of Participants Achieving Rapid Viral Response (RVR)|RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 4|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
41201|NCT01440946|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|IR for FIX activity following rFIXFc dosing: IU/dL rise in plasma FIX per IU/kg drug administered. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
41202|NCT01440946|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|MRT: the average time for all the drug molecules to reside in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
41203|NCT01440946|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|DNAUC: dose normalized area under the drug concentration-time curve (extent of unmetabolized drug in circulation). Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
41204|NCT01440946|Secondary|Volume of Distribution at Steady State (Vss; One-stage aPTT Clotting Assay)|Vss: volume of distribution at steady state. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/kg||95% Confidence Interval|Geometric Mean
41205|NCT01440946|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|CL: the measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||mL/h/kg||95% Confidence Interval|Geometric Mean
41206|NCT01440946|Secondary|Terminal Half Life (t1/2; One-stage aPTT Clotting Assay)|t1/2: time required for the concentration of the drug to reach half of its original value in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||hours||95% Confidence Interval|Geometric Mean
41207|NCT01440946|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Cmax: maximum plasma FIX activity during a dosing interval. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.||IU/dL||95% Confidence Interval|Geometric Mean
41208|NCT01440946|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.||IU/kg|Participants|Inter-Quartile Range|Median
41209|NCT01440946|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleeding episode, until the last date/time within the bleeding episode window are counted. The resolution of a bleeding episode is defined as no sign of bleeding following injection for the bleeding episode. For 'Per participant' values, the number of injections required to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.||injections|Participants|Inter-Quartile Range|Median
41210|NCT01440946|Secondary|Number of Days From the Last Prophylaxis Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.||days|Participants|Inter-Quartile Range|Median
41211|NCT01440946|Secondary|Annualized rFIXFc Consumption by Type of Injection|Annualized consumption of rFIXFc for prevention of bleeding (prophylactic), treatment of bleeding, and other rFIXFc injections. Consumption is calculated for the efficacy period. The efficacy period began with the first prophylactic dose of rFIXFc and ended with the last dose (regardless of the reason for dosing). Surgery/rehabilitation and PK evaluation periods were not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Participants who did not have a particular injection type are counted as having zero injections for that type.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.||IU/kg rFIXFc per year||Standard Deviation|Mean
41212|NCT01440946|Secondary|Physician's Global Assessment of the Participant's Response to His rFIXFc Regimen|Investigators assessed each participant's response to his rFIXFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFIXFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received ≥ 1 dose of rFIXFc; based on the number of responses.||percentage of responses|Participants||Number
41213|NCT01440946|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response (provided by the caregiver) to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had ≥ 1 bleeding episode; based on the number of injections with an evaluation.||percent of 1st injections w/ a response|Participants||Number
41214|NCT01440946|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleeding episode=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. Efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended ≤ 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections ≤ 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken > 72 hours after the preceding 1 was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period is of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
41229|NCT01440595|Secondary|Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)|Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
41215|NCT01440946|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended no more than 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period was of at least 1 day in duration.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
41216|NCT01440946|Primary|Occurence of Factor IX (FIX) Inhibitor Development|An inhibitor test result ≥ 0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥ 50 exposure days (EDs) to rFIXFc. In addition, the incidence for all participants, regardless of their EDs to rFIXFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to 50 weeks +/- 7 days, or up to 50 EDs if reached prior to Week 50|Safety Analysis Set: participants who received at least 1 dose of prestudy FIX, or at least 1 dose of rFIXFc; n=number of participants with given number of EDs who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
41217|NCT01440881|Primary|The Examine and Measure Urinary NGAL to Measure Kidney Injury|Urinary NGAL,a biomarker for kidney injury was measured.|A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.|randomized as outlined in protocol||ng/ml||Inter-Quartile Range|Median
41218|NCT01440881|Primary|The Examine and Measure Endothelin-1 to Measure Kidney Injury|Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1.|30 days from the start of infusion|randomized as outlined in the protocol||pg/ml||Inter-Quartile Range|Median
41219|NCT01440881|Primary|The Examine and Measure Cytokines to Measure Kidney Injury|Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.|30 days from the start of infusion|randomized per protocol||pg/ml||Inter-Quartile Range|Median
41220|NCT01440881|Primary|Measure Neutrophils to Measure Kidney Injury|0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression.|30 days from the start of infusion|||log2 expression||Standard Deviation|Mean
41221|NCT01440647|Secondary|Percentage of Participants With Reintubation|Reintubation rate is a measure of the efficacy of NIPPV.|0-7 days post-extubation|||% of participants with reintubation|||Number
41222|NCT01440647|Primary|Number of Days Being Intubated||30 days from birth|||days||Full Range|Median
41223|NCT01440634|Primary|Effect of an Exercise Intervention on Walking Ability (Functional Outcome)|Walking distance (Six-Minute Walk test). Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible. A research assistant walks slightly behind each participant so as not to pace the individual. The research assistant records whether or not each person stops during the 6-minute walk. During the proposed study, members of the research team and trained lay health promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked.|6 months|||meters||Standard Deviation|Mean
41224|NCT01440595|Secondary|Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
41225|NCT01440595|Secondary|Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
41226|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)|SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
41227|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)|SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
41838|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41230|NCT01440595|Primary|Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.|||||
41231|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48||Up to 48 weeks|Full Analysis Set||percentage of participants|||Number
41232|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24||Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
41233|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.||cells/µL||Standard Deviation|Mean
41234|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.||cells/μL||Standard Deviation|Mean
41235|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)||Week 48|Full Analysis Set||percentage of participants|||Number
41236|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)||Week 24|Full Analysis Set||percentage of participants|||Number
41237|NCT01440569|Primary|Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24||Up to 24 weeks|Full Analysis Set||percentage of participants|||Number
41238|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.|6 months|Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant.||percentage of all participants|||Number
41239|NCT01440543|Secondary|Patient Comfort During the Procedure and During First 24 Hours After Procedure|Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure|six months||||||
41240|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.|six months||||||
41241|NCT01440517|Secondary|Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.|||||
41242|NCT01440517|Primary|Evidence of Active Myocardial Angiogenesis/Remodeling|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.|||||
41243|NCT01440387|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
41244|NCT01440387|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
41245|NCT01440387|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were chest tightness, chills, cough, fatigue, headache, joint pain at other location, muscle pain, red eyes, sore throat, swelling of the face and fever [oral temperature ≥ 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
41246|NCT01440387|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling greater than 100 millimeters (mm). i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
41247|NCT01440387|Primary|HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.|SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
41248|NCT01440387|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
41249|NCT01440387|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
41250|NCT01440387|Primary|Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.|Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
41251|NCT01440374|Primary|Percentage of Participants With Clinically Relevant Thrombocytopenic Events (CRTE) From Week 5 up to Week 12 During Part 2|A participant was considered to have a CRTE at a given assessment if he/she had platelet counts <10 Gi/L, or platelet transfusions, or >=Grade 3 hemorrhagic adverse events. CRTEs during Weeks 5 to 12 were compared between treatments using a generalized linear mixed model. Average of weekly proportion of subjects with CRTE during Week 5 to 12 was estimated for each treatment. Intent to Treat (ITT) Population was comprised of all randomized participants during Part 2.|From Week 5 up to Week 12 during Part 2|ITT Population||Percentage||95% Confidence Interval|Mean
41252|NCT01440374|Primary|Number of Participants With Platelet Response up to Week 8 During Part 1|A participant was considered as a responder if he/she met the following response criteria: a Baseline platelet count <20 Giga cells per liter (Gi/L) and a post-Baseline increased to >20 Gi/L and at least 2 times the Baseline value; or a Baseline platelet count >=20 Gi/L and a post-Baseline absolute platelet count increased to >=50 Gi/L and at least 2 times the Baseline value. The response criteria was evaluated at each visit. Increase in platelet count observed up to 3 days after a platelet transfusion was not considered as a platelet response. The Part 1 Population was comprised of all participants enrolled into Part 1.|From Baseline up to Week 8 during Part 1|Part 1 Population||Participants|||Number
41253|NCT01440322|Secondary|Back Surface Deposits (None, Very Slight)|"Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
41254|NCT01440322|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
41255|NCT01440322|Secondary|Dry Areas/Non-Wetting (None, Very Slight)|"Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
41256|NCT01440322|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
41257|NCT01440322|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of lenses|Participants||Number
41258|NCT01440322|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."||Units on a scale||Standard Deviation|Mean
41259|NCT01440322|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."||Units on a scale||Standard Deviation|Mean
41260|NCT01440322|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."||Units on a scale||Standard Deviation|Mean
41261|NCT01440322|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."||Percentage of eyes|Participants||Number
41262|NCT01440283|Secondary|Quantify (in mm/cm) the Range of Target Movement During the Breathing Phase Measured by 4DMRI and 4DCT.|Obtain target tissue motion-defining data which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue.|Baseline and approximately 2 weeks following initiation of irradiation.|All participants underwent complete surgery prior to RT, therefore, no visible tumor tissue target was available for movement measurements.|||||
41263|NCT01440283|Secondary|Quantify the Range of Organ Movement During the Breathing Phase Measured by 4-dimensional MRI (4DMRI) and 4DCT.|Normal tissue motion-defining measurements were obtained which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue. Participants underwent CT simulation and 4D-CT acquisition as well as real-time dynamic 4D MRI prior to the start of radiation therapy (RT), and a subsequent repeat 4D-CT was obtained approximately 2 weeks after the start of RT. The imaging position was supine with general anesthesia. Renal edges were marked in a customized graphical interface for each imaging series with the image resolution determining the minimum motion extent. Vectors of renal edge motion were quantified in the anterior-posterior (A-P), medial-lateral (M-L), and superior-inferior (S-I) dimensions. The motion extent derived from the MRI dataset was considered in defining the margins for RT treatment planning.|Baseline and approximately 2 weeks following initiation of irradiation.|Five participants did not receive all scans for motion evaluations and are excluded from the analysis. Age at scan ranges from 8 months to 9.5 years old. The median age was 3.8 years.||mm||Standard Deviation|Mean
41264|NCT01440283|Primary|Pattern of Local-regional Failure.|Categorical measurements of local-regional failure.|2 years after last patient enrollment|There was no local-regional failure noted (please see outcome #1), therefore, no pattern of failure could be determined.|||||
41265|NCT01440283|Primary|Percentage of Participants Who Failed to Reach Local-regional Control|Measured from start of radiation therapy to date of local-regional failure or last follow-up.|2 years after last patient enrollment|||percentage of participants|||Number
41266|NCT01440101|Secondary|Part A: Summary of Lymphocyte Counts Over Time||Baseline [Week 0]); 28 days post-dose; Weeks 12, 24, and 32 (follow-up)|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of lymphocytes; n=participants with assessment at timepoint.||cells/microliter||Standard Deviation|Mean
41267|NCT01440101|Secondary|Part A: Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)|Pharmacodynamic activity was assessed by measuring the degree of saturation by BG00002 of the very late antigen-4 (VLA-4, also known as α4β1 integrin) receptor on peripheral blood mononuclear cell populations. This was accomplished by staining cells with phycoerythrin-conjugated anti-human immunoglobulin G4 (IgG4) antibody (hIgG4-PE) to label the cell-bound BG00002, followed by flow cytometric detection and quantification.|Pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose; Weeks 8, 12, and 16: pre-dose; Week 20: pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of α4-integrin saturation; n=participants with an assessment at timepoint.||percent saturation||Standard Deviation|Mean
41268|NCT01440101|Secondary|Part B: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24|||participants|||Number
41269|NCT01440101|Secondary|Part B: Status of Serum Antibodies to Natalizumab|Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Baseline (Week 0) and Week 24|Participants with one or more post-baseline screening antibody result.||participants|||Number
41270|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: CL|Systemic clearance (CL) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration.||mL/h||Full Range|Geometric Mean
41271|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Vd|Volume of distribution (Vd) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||L||Full Range|Geometric Mean
41272|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Tmax and T1/2|Time to maximum concentration (Tmax) and half-life (T1/2) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||hours||Full Range|Geometric Mean
41273|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: AUC(0-last) and (0-AUC∞)|Area under the curve to the last measurable concentration (AUC[0-last]); and area under the curve extrapolated to infinity (0-AUC∞) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||µg*h/mL||Full Range|Geometric Mean
41274|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Cmax|Observed maximum concentration (Cmax) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.||µg/mL||Full Range|Geometric Mean
41275|NCT01440101|Secondary|Part B: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Baseline (Week 0), Week 12, Week 24|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint. Participants with values <LLQ were not counted in the n for that timepoint.||µg/mL||Standard Deviation|Mean
41276|NCT01440101|Secondary|Part A: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Week 0: pre-dose, post-dose and 2, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose; Weeks 4, 8, 12, and 16: pre-dose; Week 20 pre-dose, post-dose, and 2, 24, 48 and 96 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants who received at least 1 infusion of BG00002 with at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of participants with an assessment at given timepoint. At Weeks 8, 12, and 16, one participant had values less than the lower limit of quantitation (<LLQ) and was not counted in the n for that timepoint.||µg/mL||Standard Deviation|Mean
41277|NCT01440101|Secondary|Part B: Change From Baseline to Weeks 12 and 24 in the Global Assessment of Well-Being As Assessed by Participants Using a Visual Analog Scale (VAS)|The participant's self-rating of global impression of his/her well-being was assessed with a VAS. The instrument ranged from 0 to 100 (mm), where a score of 0 denoted 'poor' and a score of 100 denoted 'excellent.'|Baseline (Week 0), Week 12, Week 24|n = all participants with an assessment at baseline and given timepoint.||units on a scale||Standard Deviation|Mean
41278|NCT01440101|Secondary|Part B: Number of Participants Who Were Relapse Free Over 24 Weeks|Participants were categorized as relapse free=yes, relapse free=no, or relapse free=unknown. The category of relapse free=unknown includes participants who withdrew from the study and did not experience a relapse prior to withdrawal.|Baseline (Week 0) to Week 24|All participants who received study drug.||participants|||Number
41279|NCT01440101|Secondary|Part B: Cumulative Number Of New Or Newly Enlarging, Non-Enhancing T2-Hyperintense Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions||Standard Deviation|Mean
41280|NCT01440101|Secondary|Part B: Cumulative Number of Gd+ Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions||Standard Deviation|Mean
41281|NCT01440101|Secondary|Part B: Adjusted Annualized Relapse Rate Over 24 Weeks|The frequency of clinical exacerbations over 24 weeks was assessed using an annualized relapse rate that was calculated for each treatment group as the total number of relapses experienced in the group over the 24 weeks of treatment, divided by the total number of subject-years followed in the study. Obtained from a Poisson regression model, adjusted for the baseline relapse rate.|Week 24|||relapses per year|Participants|95% Confidence Interval|Number
41282|NCT01440101|Secondary|Part B: Cumulative Number of New Active Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions||Standard Deviation|Mean
41283|NCT01440101|Primary|Part B: Rate of Development of New Active Lesions Over 24 Weeks|New active lesions were the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly enlarging T2 hyperintense lesions that did not enhance as seen on cranial magnetic resonance imaging (MRI) scans. The rate is calculated for each participant as the ordinary least squares slope of the cumulative new active lesions over time.|Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.||lesions per week over 24 weeks||Standard Deviation|Mean
41284|NCT01440101|Primary|Part A: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24|All participants who received study drug.||participants|||Number
41285|NCT01440049|Other Pre-specified|Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population|Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.|Baseline|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41286|NCT01440049|Other Pre-specified|Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population|New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.|Baseline, Months 3, 6, 9, 12|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||Percentage of participants||95% Confidence Interval|Number
41287|NCT01440049|Other Pre-specified|Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.|Baseline up to Month 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||mmol/L||Standard Deviation|Mean
41288|NCT01440049|Other Pre-specified|Maximum Kalaemia Levels in Serum in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||mmol/L||Standard Deviation|Mean
41289|NCT01440049|Other Pre-specified|Number of Measurements Per Month for Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.|Months 3, 6, 9, 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||Measurements per month||Standard Deviation|Mean
41290|NCT01440049|Other Pre-specified|Percentage of Participants With General Practitioner (GP) Consultation in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.||Percentage of participants||95% Confidence Interval|Number
41305|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
47862|NCT01348139|Secondary|E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.|Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.|FEV1 at 5 min|PD analysis set||Liters||Standard Deviation|Mean
41291|NCT01440049|Other Pre-specified|Percentage of Participants With Other Notable Events in FAS Population|Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.||Percentage of participants||95% Confidence Interval|Number
41292|NCT01440049|Secondary|Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population||Baseline up to Month 12|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41293|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in SAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|SAS population included all participants who received study medication.||Participants|||Number
41294|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in FAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.||Participants|||Number
41295|NCT01440049|Secondary|Number of Participants With Reason for Increased or Decreased Eplerenone Dose||Baseline up to Month 12|Data were not statistically summarized and were provided in individual participant listings as per the planned analysis.|||||
41296|NCT01440049|Primary|Number of Participants With Worsened Renal Function||Baseline up to Month 12|Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study.|||||
41297|NCT01440049|Primary|Percentage of Participants Hospitalized in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41298|NCT01440049|Primary|Percentage of Participants Who Died in SAS Population||Baseline up to Month 12|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41299|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41300|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41301|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41302|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 3|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.||Percentage of participants||95% Confidence Interval|Number
41303|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41304|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41306|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population|Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.|Month 3|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
41307|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of EDV||Standard Deviation|Mean
41308|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.||Percentage of EDV||Standard Deviation|Mean
41309|NCT01439724|Secondary|Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.|Oral mucositis survival free, pain, opioid treatment, hospitalization, treatment interruption, treatment delay, patient weight loss, nasogastric tube or of a gastrostomy.The oral cavities of all patients were evaluated, from the first day to the last day of treatment.|7 weeks||||||
41310|NCT01439724|Primary|Incidence and / or Severity of Oral Mucositis|The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.|7 weeks|Data related to the primary endpoint were handled in a per protocol treatment analysis.||Grade 3-4 oral mucositis|||Number
41311|NCT01439672|Primary|Insulin Sensitivity|Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.|24 hours|||1/min per uU/mL||Standard Deviation|Mean
41312|NCT01439282|Secondary|Number of Patients With Adverse Events of 4 Cycles of Eribulin Plus Capecitabine in the Adjuvant Setting|"Safety will be assessed by the monitoring and recording all AEs and serious adverse events (SAEs), regular monitoring of hematology and clinical chemistry, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status, regular physician assessments, concomitant medications, medical histories, and physical examinations.~Not posted. Treatment-emergent adverse events (TEAEs) and SAEs will be reported with the AEs and SAEs."|12 weeks||||||
41313|NCT01439282|Secondary|Use of Cold Cap for Alopecia|Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.|On the day of study drug infusion treatments during Cycles 1 through 4|Safety analysis set included all participants who received at least one dose of study treatments and had at least one postbaseline safety assessment.||Participants|||Number
41314|NCT01439282|Primary|Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%|Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant’s body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.|21-Day Cycle 1 through 21-Day Cycle 4|Full analysis set included all participants who received at least one dose of eribulin mesylate plus capecitabine.||Percentage of participants||95% Confidence Interval|Number
41315|NCT01439204|Secondary|Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population|12-lead electrocardiograms were performed on a supine participant (5 minutes supine) at baseline (baseline = screening; Days -21 to -2) and at Day 71. QT interval and QTc were measured in mille seconds (msec). A change from baseline QT and QTc (corrected for heart rate by Fridericia formula) greater than (>) 30 msec or less than (<) 60 msec were presented, as well as values over 450 and 500 msec. QT interval on ECG image defined as: time from the beginning of the QRS (complex consisting of Q, R and S waves) to the end of the T wave.|Day 1 to Day 71|All participants who received study drug and had at least one ECG value.||participants|||Number
41430|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months|||mmHg||Standard Deviation|Mean
41316|NCT01439204|Secondary|Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had diastolic assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||mmHg||Standard Deviation|Mean
41317|NCT01439204|Secondary|Change From Baseline in Systolic Blood Pressure - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had systolic assessment were included in the analysis. Days 1 and 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||mmHg||Standard Deviation|Mean
41318|NCT01439204|Secondary|Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population|Blood samples obtained: Days 2, 4, 8, 15, 22, 29, 43, 57 and 71. Male(M); Female (F). Reference ranges (low/high) for laboratory parameters for which participants were identified with marked abnormalities during the study: Leukocytes (quantitative White blood cells) (M/F) 4-11*10^3/microliters (µL); Neutrophils (absolute)(M/F) 1.4- 8.2*10^3/µL.|Day 2 to Day 72|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||participants|||Number
41319|NCT01439204|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population|Blood samples obtained: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71. International Units per liter (U/L); milligram per deciliter (mg/dL); Male(M); Female (F). Reference ranges (low/high) for laboratories for which participants were identified with marked abnormalities during the study: Blood Urea Nitrogen (M/F) 10-20mg/dL ; Creatine Kinase (F) 21-21 U/L,(M) 32-294 U/L; Direct Bilirubin (M/F) 0.1-0.4 mg/dL ; Fasting Glucose (M/F) 70-110 mg/dL; Lactate Dehydrogenase (M/F) 110-209 U/L.|Day 2 to Day 71|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).||participants|||Number
41320|NCT01439204|Secondary|Number of Participants With Positive Abatacept-induced Immunogenicity Response|Immunogenicity determination was based on titers of anti-abatacept and anti- cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4-T) antibodies in serum over time. A participant had a positive abatacept-induced immunogenicity if 1 of the following criteria were met: missing baseline measurement and a positive response after baseline; negative baseline response and positive response after baseline; a baseline response and a positive response after baseline that has a titer value strictly greater than the baseline titer value. A validated, sensitive, electrochemiluminescence assay (ECL) method was used to analyze the antibodies in serum. Samples confirmed positive with ECL and with abatacept serum concentrations of less than equal to 1 µg/mL were further analyzed with a validated, in vitro, cell-based bioassay to analyze the sera containing the abatacept neutralizing activity. Samples obtained on Days 29, 57 and 71 post dose of abatacept on Day 1 (baseline).|Days 29, 57, 71|Immunogenicity Data Set: All participants with at least 1 postdose visit.||participants|||Number
41321|NCT01439204|Primary|Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Vss was measured in liters per kg body weight (L/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||L/kg||Geometric Coefficient of Variation|Geometric Mean
41322|NCT01439204|Primary|Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
41323|NCT01439204|Primary|Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). T-HALF was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||h||Standard Deviation|Mean
41324|NCT01439204|Primary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - INF) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - INF) was measured in µg*h/mL.|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
41325|NCT01439204|Primary|Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - T) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - T) was measured in micro grams*hour per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
41326|NCT01439204|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - 28) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - 28) was measured in micro grams*hours per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
41327|NCT01439204|Primary|Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Tmax was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.||h||Full Range|Median
41328|NCT01439204|Primary|Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).|Days 1 to 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles. All completers had evaluable PK.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
41329|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Changes in the Columbia Suicide Severity Rating Scale (C-SSRS)|"The outcome reported is the number of subjects that responded Yes to the question “Do you have a wish to be dead” at Visit 20.~C-SSRS is a clinician-rated instrument designed to provide consistent and systematic assessment of both suicidal ideation and behavior within a study, as well as across studies. The scale is a feasible, low burden series of questions that appropriately assess and track all suicidal events, including ideation. Suicidal ideation is assessed according to yes/no responses to 5 questions of increasing severity (from a wish to die to an active thought of killing oneself with plan and intent) as follows:~Wish to be Dead~Non-Specific Active Suicidal Thoughts~Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Active Suicidal Ideation with Specific Plan and Intent"|Visit 20 (Week 40)|Double-Blind Full Analysis Set||participants|||Number
41330|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs||From study start to study end (40 weeks)|Double-Blind Full Analysis Set||Participants|||Number
41331|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Epworth Sleepiness Scale for Children (ESS-C)|"Change in the ESS-C scale from randomization to end of randomized-withdrawal period. The ESS-C is a simple eight-tem Likert scale designed to assess daytime sleepiness in children aged 2-18 years. The scale takes less than two minutes to be completed by patient or by parent rating. Sleepiness is a common symptom in both medicated and unmedicated children with ADHD given the predominance of impaired sleep quality. The total score achieved when the chance of dozing in each situation is added up serves as the outcome measure.~The ESS-C comprises 8 items describing various daytime activities. Item scores ranging from 0 (“would never doze or sleep”) to 3 (“high chance of dozing or sleeping”). A total score is derived as the sum of the items, with higher total scores indicative of a greater level of sleepiness (worse outcome). Total scores range from 0 to 24."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||units on a scale||Standard Deviation|Mean
41332|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P)|"The WFIRS-P is designed to assess the impact of child’s behavior or emotional problems on 7 domains related to function: Family (10 items), School Learning (4 items), School Behavior (6 items), Life Skills (10 items), Child’s Self-concept (3 items), Social Activities (7 items), and Risky Activities (10 items). Each item was scored on a scale ranging from 0 (“never or not at all”) to 3 (“very often or very much”). Each scale score was calculated as the average for that scale. The total score is the average of all non-missing items. Higher scores are associated with greater impact of disease on functioning."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||units on a scale||Standard Deviation|Mean
41351|NCT01438814|Secondary|Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)||participants|||Number
41333|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Clinical Global Impressions-Severity of Illness Scale (CGI-S)|"The CGI-S is a clinician rated instrument designed to assess the subject’s current illness state. The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||scores on a scale||Standard Deviation|Mean
41334|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the ADHD-Rating Scale-4th Edition (ADHD-RS-IV)|The ADHD-RS-IV (clinician version), has been widely used as a measure of efficacy in clinical trials of treatments in children and adolescents with ADHD. It is derived from the 18 inattentive and hyperactive/impulsive diagnostic criteria for ADHD from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). The clinician version of the ADHD-RS-IV has a large base of normative data and has demonstrated reliability and discriminant validity in children and adolescents. The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse and a lower score more favourable). Two subscales are summed.|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set||scores on a scale||Standard Deviation|Mean
41335|NCT01439126|Secondary|To Evaluate the Long-term Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Time to Treatment Failure From the Start of Randomized-withdrawal Period|Time to treatment failure was calculated as follows: Treatment failure (not premature termination) = visit date where the failure criteria was met – visit 9 date + 1; Treatment failure (premature termination) = termination date – visit 9 date + 1|Time From randomization to treatment failure (up to 26 weeks)|Double-Blind Full Analysis Set||days||95% Confidence Interval|Median
41336|NCT01439126|Primary|Long-term Maintenance of Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Percentage of Treatment Failures in the KAPVAY vs. Placebo Groups|"Treatment failure a ≥30 percentage increase (worsening)(ADHD-RS-IV, clinician version) total score and a ≥2 point increase (worsening) in Clinical Global Impressions-Severity of Illness Scale (CGI-S) at any two consecutive visits during the randomized-withdrawal period.~The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse).~The CGI-S is a 7-point scale,1 (Normal, not at all ill) to 7 (extremely ill patients).The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set. This set included all randomized subjects who took at least 1 dose of study medication during the double blind (randomized-withdrawal) phase||% of Participants|||Number
41337|NCT01439074|Secondary|% of Study Burn Healed After One Week||1 week|||percentage of study burn healed||Standard Deviation|Mean
41338|NCT01439074|Secondary|Number of Dressing Changes|Including first assembly|4 weeks|||applications||Standard Deviation|Mean
41339|NCT01439074|Secondary|Percent of Burn Epithelised/Healed|Healing will be defined as 95% or more epithelialisation|4 weeks|||percentage of study burn healed||Standard Deviation|Mean
41340|NCT01439074|Primary|Time to Healing|Number of days|4 weeks|||days||Standard Deviation|Mean
41341|NCT01438996|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 28-day period after vaccination|||participants|||Number
41342|NCT01438996|Secondary|Number of Subjects Reporting AE|AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)|During the 28-day period after vaccination|||participants|||Number
41343|NCT01438996|Secondary|Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.|During the 7-day period after vaccination|||participants|||Number
41344|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 28 days after vaccination as compared to baseline|||percentage of subjects||95% Confidence Interval|Number
41345|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 7 days after vaccination as compared to baseline|||percentage of subjects||95% Confidence Interval|Number
41346|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 3 days after vaccination as compared to baseline|||percentage of subjects||95% Confidence Interval|Number
41347|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA|At 28 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
41348|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA|At 7 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
41349|NCT01438996|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)|At 3 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
41350|NCT01438814|Secondary|Change From Baseline in HbA1c Over Time|Means are adjusted by treatment and continuous baseline HbA1c|Baseline, 2 weeks and 8 weeks|Patients from FAS1000 (LOCF)||percent||Standard Error|Mean
41353|NCT01438814|Secondary|Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)||participants|||Number
41354|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment).|14 weeks|Patients from the FAS1000 (NCF)||participants|||Number
41355|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)||participants|||Number
41356|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF) having a baseline HbA1c>=6.5%.||participants|||Number
41357|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment|The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c.|14 weeks|Patients from the FAS1000 using original results (OR) and having GI adverse events which were assessed for severity by the patient.||units on a scale||Standard Error|Mean
41358|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment|Patients could experience multiple events, therefore, multiple answers were possible for each patient.|14 weeks|Patients from FAS1000 and having GI adverse events which were assessed for severity by the investigator.||events|Participants||Number
41359|NCT01438814|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 14 weeks|Patients from FAS1000 with LOCF||mg/dL||Standard Error|Mean
41360|NCT01438814|Secondary|Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment|Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks|14 weeks|Patients from FAS1000||participants|||Number
41361|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment)|14 weeks|Patients from FAS1000 with non-completer considered as failure (NCF) having a baseline HbA1c>=7.0%.||participants|||Number
41362|NCT01438814|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment|Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c.|Baseline and 14 weeks|FAS1000mg with last observation carried forward (LOCF): all patients randomised and treated who had a baseline at least 1 on-treatment HbA1c value and who tolerated a daily metformin dose of at least 1000 mg at the end of the titration phase.||percent||Standard Error|Mean
41363|NCT01438710|Primary|Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.|"The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion.~The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor.~Below the mean total score and standard deviation for each treatment is given in addition to the mean change."|14 days|"Of the 40 patients who completed the study period, 38 patients were evaluable for efficacy evaluation and included in the modified intention to treat (mITT) population.~The outcome measure is given as total score below."||units on a scale||Standard Deviation|Mean
41364|NCT01438541|Secondary|Evaluate the Dressing Shape|Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent|14 days|||participants|||Number
41365|NCT01438541|Secondary|Overall Experience of Use of the Dressing|Investigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured|14 days|||participants|||Number
41366|NCT01438541|Primary|Erythema ( No/Yes)|Total improvement of erythema|14 days|Vulnerable subjects with high risk of skin breakdown.||participants|||Number
41367|NCT01438489|Secondary|Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365|Accumulation ratio for trough concentration (Ctrough,AR) of anifrolumab after multiple administration at Day 169 and 365 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||Ratio||Full Range|Median
41368|NCT01438489|Secondary|Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365|Trough concentration (Ctrough) of anifrolumab at Day 29, 169 and 365 were calculated.|Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||microgram per milliliter||Standard Deviation|Mean
47863|NCT01348139|Secondary|tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit|Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.|0 - 24 hrs.|PD analysis set||Hours||Full Range|Median
41369|NCT01438489|Secondary|Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab|Accumulation ratio for maximum plasma concentration (Cmax,AR) of anifrolumab after multiple administration at Day 169 and 337 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||Ratio||Full Range|Median
41370|NCT01438489|Secondary|Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337|Maximum plasma concentration (Cmax) was defined as the peak plasma level of anifrolumab, derived from plasma concentration ­time data.|Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
41371|NCT01438489|Secondary|Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature|The PD positive and negative gene signature was determined by comparing the expression of type I IFN-inducible genes in a 21-gene panel in study participants relative to pooled normal blood collected from healthy participants.|Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."||Ratio||Standard Deviation|Mean
41372|NCT01438489|Secondary|Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)|Anti-drug antibody responses to anifrolumab in serum were evaluated.|Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)|"The safety population included participants who received any investigational product. Here, N and “n” signifies evaluable participants for this outcome measure and for specified category of the arms respectively. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in Anifrolumab 1000 mg group."||Percentage of Participants|||Number
41373|NCT01438489|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant changes from the screening ECG was recorded as TEAEs. An abnormal ECG findings such as QT prolonged were reported as treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
41374|NCT01438489|Secondary|Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign parameters are temperature, blood pressure, respiratory rate, heart rate and weight. Vital signs abnormalities were reported as TEAEs.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
41375|NCT01438489|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events|Any medically significant change in laboratory evaluations were recorded as Treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
41376|NCT01438489|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A serious AE (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly (in offspring of participant). AEs may be treatment emergent (TE) [that is, occurring after initial receipt of investigational product] or non-TE. An AESI is one of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by investigator to sponsor.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."||Participants|||Number
41377|NCT01438489|Secondary|Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365|Participants on OCS >=10 mg/day of prednisone or equivalent at baseline who were able to taper to <= 7.5 mg/day at Day 365 were evaluated.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
41378|NCT01438489|Secondary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365|An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the MDGA (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 281 through Day 365 (less than 10 mg/day and less or equal to the dose received on Day 1). SRI was analyzed by a logistic regression model.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
41379|NCT01438489|Primary|Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169|Type I IFN signature in whole blood assessed by using a 4-gene diagnostic test. The blood samples collected were to be used to prospectively identify participants as IFN test-high or test-low. The results of this test were used to stratify participants. An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 mg/day and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
41380|NCT01438489|Primary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169|An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index ‘A’ organ system score and no more than one new or worsening BILAG-2004 Index ‘B’ organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The modified Intent-To-Treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."||Percentage of Participants|||Number
41381|NCT01438424|Secondary|Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and had serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)||Log10 copies/mL||Standard Error|Mean
41382|NCT01438424|Secondary|Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR Assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. ULN=upper limit of normal.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)||Percentage of participants|||Number
41383|NCT01438424|Primary|Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal.|End of dosing to Week 48 off-treatment follow-up|Participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.||Percentage of participants|||Number
41384|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from study AI463-027 who were nucleoside-naive HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41385|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-027 who were nucleoside-naive HBeAg-negative, received lamivudine, and had >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41431|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months|||mmHg||Standard Deviation|Mean
41386|NCT01438424|Primary|Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 192|Participants who enrolled from Phase 3 studies of nucleoside-naive HBeAg-positive (AI463-022) and HBeAg-negative (AI463-027) participants and received at least 1 dose of study drug in the current study up to Week 192. (n=number of evaluable participants)||Participants|||Number
41387|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41388|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41389|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort)|The Entecavir Retreatment Cohort consisted of participants who were nucleoside-naive, HBeAg-negative and enrolled from BMS study AI463-027 with >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as retreatment in the current study.|Baseline to Weeks 48, 96, and 144|Participants enrolled from study AI463-027 who were nucleoside-naive, HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41390|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort)|The Entecavir Continuous Treatment Cohort consisted of participants from study AI463-022 (NCT00035633) who were nucleoside-naive HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current. This cohort is considered to be on continuous entecavir treatment and permitted assessment of continuous administration of entecavir in AI463-022 and the current study.|Baseline to Weeks 48, 96, 144, 192, and 240|Participants enrolled from study AI463-022 who were nucleoside-naive, HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current study and were evaluable. (n=number of evaluable participants)||Percentage of participants|||Number
41391|NCT01438424|Primary|Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 144|Participants enrolled up to Week 144 who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
41392|NCT01438424|Secondary|Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay||Baseline to Week 144|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41393|NCT01438424|Primary|Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing|Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-<90; Gr 3=80-<85; Gr 4=40-<80. Hyperchloremia: Gr 1=113-<117; Gr 2=117-<121; Gr 3=121-125; Gr 4>125. Hypocarbia: Gr 1=19-21; Gr 2=15-<19; Gr 3=41-45; Gr 4=>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=>45. Hyponatremia: Gr 1=130-132; Gr 2=123-<130; Gr 3=116-<123; Gr 4<116. Hypernatremia: Gr 1=148-<151; Gr 2=151-<158; Gr 3=158-165; Gr 4=>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-<3; Gr 3=2-<2.5; Gr 4=<2. Hyperkalemia: Gr 1=5.6-<6.1; G2=6.1-<6.6; Gr 3=6.6-7; Gr 4=>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-<55; Gr 3=30-< 40; G4=-<30. Hyperglycemia: Gr 1=116-<161; Gr 2=161-<251; Gr 3=251-500; Gr 4>500.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
41432|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months|||mmHg||Standard Deviation|Mean
41394|NCT01438424|Primary|Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing|Amylase: Grade 1=1.10-<1.40*ULN; Grade 2=1.40-< 2.10*ULN; Grade 3=2.10-5.00*ULN; Grade 4=>5.00*ULN. Lipase: Grade 1.1-<1.4*ULN; Grade 2=1.4-<2.1*ULN; Grade 3=2.1-5.0*ULN; Grade 4=>5.0*ULN. Creatinine: Grade 1=1.10-< 1.60*ULN; Grade 2=1.60-<3.10*ULN; Grade 3=3.10-6.00*ULN; Grade 4=>6.00*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-<2.60*ULN; Grade 2=2.60-<5.10*ULN; Grade 3=5.10-10*ULN; Grade 4=>10*ULN. ULN=upper limit of normal.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
41395|NCT01438424|Primary|Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240|Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-<9.5; Gr 3=6.5-<8.0; Gr 4=<6.5 White blood cells (cells/mm^3): Gr 1=2,500-<4,000; Gr 2=1,000-<2,500; Gr 3=800-<1,000; Gr 4=<800. Neutrophils (cells/mm^3): Gr 1=1000-<1500; Gr 2=750-<1000; Gr 3=500-<750; Gr 4=<500. Platelets (cells/mm^3): Gr 1=75,000-99,000; Gr 2=50,000-<75,000; Gr 3=20,000-<50,000; Gr 4=<20,000. Prothrombin time (seconds): Gr 1=1.01-<1.26*ULN; Gr 2=1.26-<1.51 *ULN; Gr 3=1.51-3*ULN; Gr 4=>3*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=>3. INR=international normalized ratio; ULN=upper limit of normal. .|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Participants|||Number
41396|NCT01438424|Secondary|Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)|The Ishak Modification for Hepatic Activity Index (HAI) scores necroinflammatory activity in chronic hepatitis. 0=no fibrosis, 1=fibrosis expansion of some portal areas, 2=fibrosis expansion of most portal areas, 3=fibrosis expansion of most portal areas with occasional bridging, 4=fibrosis expansion of portal areas with marked bridging, 5=incomplete cirrhosis, 6=probable or definite cirrhosis. Higher score=more severe necrosis. Improvement in fibrosis=≥1-point reduction in HAI score. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)||Percentage of participants||95% Confidence Interval|Number
41397|NCT01438424|Secondary|Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)|The Knodell Histologic Activity Index scores stage of necrosis and grade of inflammation in liver biopsies. Components are necrosis near the portal vein, intralobular degeneration and focal necrosis, portal inflammation, and fibrosis. The 4 components are scored from 1 to 4 and 1 to 10 (necrosis near the portal vein) and combined for a total score, with 22 being the highest possible score. Higher the score for each component=greater liver damage. Histologic improvement=a ≥2-point reduction in total Knodell score and no worsening in fibrosis. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell necroinflammatory scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)||Percentage of participants||95% Confidence Interval|Number
41398|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved ALT Normalization|ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0*ULN.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41399|NCT01438424|Secondary|Overall Study: Mean Alanine Transaminase (ALT) Levels|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||U/L||Standard Deviation|Mean
41400|NCT01438424|Secondary|Overall Study: Percentage of Participants With HBeAg Seroconversion|Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41401|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41402|NCT01438424|Secondary|Overall Study: Mean HBV DNA Level by PCR Assay||Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||log10 copies/mL||Standard Deviation|Mean
41403|NCT01438424|Primary|Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal.|Continuously from Day 1 through Week 240|All participants who received at least 1 dose of study drug in the current study.||Participants|||Number
41404|NCT01438424|Secondary|Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay|Observed values.|Baseline to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41405|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41406|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)||Percentage of participants|||Number
41433|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months|||mmHg||Standard Deviation|Mean
41407|NCT01438294|Other Pre-specified|Energy Expenditure|Was measured using a biaxial accelerometer (SenseWearTM Pro activity monitor, USA) (Kuys et al. 2011). The equipment was always used on the upper right limb for the determination of skin temperature, galvanic skin response and movement. Energy expenditure was calculated in metabolic equivalents (METS) and calories per minute. The SenseWear arm bandTM was used during the exercise sessions as a comparative parameter of effort intensity in the VGG and TG. The energy expenditure at rest, medium and maximum effort was the average of all sessions of all children.|baseline and during all training sessions 8 weeks||||||
41408|NCT01438294|Other Pre-specified|Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease|"Asthma control questionnaire (ACQ) is a standardized toll to assess clinical control in asthmatic patients and consists of 7 questions, 5 related to asthma symptoms, one regarding the use of short- acting ß2 agonists as rescue medication, and one regarding FEV1 before bronchodilator in percent of predicted.~ACQ score is the average these items and ranges from 0 (completely controlled) to 6 (uncontrolled) obtained in a 7 days period. The total points is divided by six to provide the final score ( six questions with range 0 to 6 points, maximal 36 points divided by six maximal 6 and mimimal 0)~The cutoff point for controlled/uncontrolled asthma is 2 points. Patient was classified according ACQ scores into controlled (<0.75), partially controlled (0.75-1.5) and uncontrolled asthma (>1.5). A minimal clinical important difference is 0.5 on a 7-point scale (Juniper et al.2005, Leite et al. 2008 and Ko et al. 2012)."|clinical control week 8|||units on a scale||Inter-Quartile Range|Median
41409|NCT01438294|Secondary|Pulmonary Function|was performed before and after the inhalation of 400μg of salbutamol (Easy One™, USA), and technical procedures were performed as recommended by ATS/ERS. Predicted normal values were those proposed by Polgar and Promadhat 1971 and a 12% and 200 mL increase in FEV1 from baseline were characterized as a positive response to the bronchodilator) in a climate-controlled room.|baseline and after 8 weeks||||||
41410|NCT01438294|Secondary|Body Composition|All participants were evaluated individually, always during the afternoon to avoid circadian changes. Height, weight and abdominal circumference were determined. Tetrapolar bioimpedance was measured using the Biodynamics™ model 310 (Biodynamics Corporation Seattle WA, USA) by positioning the child in the supine position and electrodes in the extremity of the right upper and lower limbs (Goran et al.1993).|baseline and after 8 weeks||||||
41411|NCT01438294|Secondary|Treadmil Test (Bruce Protocol)|"A maximal exercise testing was performed in a treadmill using Bruce protocol that has been used to provide information on exercise capacity, physiopathological characteristics during effort, the efficacy of medications and the potential risk for diseases ( Zijp et al. 2010). The test was interrupted when the child reported maximal fatigue or reached the maximum heart rate around 200bpm (Peyer et al. 2011). During the test, blood pressure and peripheral oxygen saturation were quantified and an electrocardiogram was performed. The Borg scale was used to quantify for the sensation of shortness of breath during effort and at rest (Lamb 1995).~Change from baseline in the distance walked on treadmill test will be consider as outcome measure."|8 week distance walked on treadmill test|||meters||Standard Deviation|Mean
41412|NCT01438294|Primary|Exhaled Nitric Oxide (FeNO) Level|"The measurement of exhaled FeNO level is performed by several commercially available devices, however the equipment NIOX ® (Aerocrine, Sweden) analyzer is the only FDA-approved and Anvisa (Food and Drug Administration) for clinical monitoring of asthma.~The measure will be performed before and after the training program of exercise, or pulmonary rehabilitation, by means of portable equipment NIOX MINO ®."|The FeNO level was performed in week 8|||ppb||Standard Deviation|Mean
41413|NCT01438229|Other Pre-specified|Cystatin C||24 months|||mg/L||Standard Deviation|Mean
41414|NCT01438229|Other Pre-specified|Cystatin C||18 months|||mg/L||Standard Deviation|Mean
41415|NCT01438229|Other Pre-specified|Cystatin C||12 months|||mg/L||Standard Deviation|Mean
41416|NCT01438229|Other Pre-specified|Cystatin C||6 months|||mg/L||Standard Deviation|Mean
41417|NCT01438229|Other Pre-specified|Cystatin C||Baseline|||mg/L||Standard Deviation|Mean
41418|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|24 months|||mL/min per 1.73m^2||Standard Deviation|Mean
41419|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|18 months|||mL/min per 1.73m^2||Standard Deviation|Mean
41420|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|12 months|||mL/min per 1.73m^2||Standard Deviation|Mean
41421|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|6 months|||mL/min per 1.73m^2||Standard Deviation|Mean
41422|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|Baseline|||mL/min per 1.73m^2||Standard Deviation|Mean
41423|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||24 months|||mg/g||Standard Deviation|Mean
41424|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||18 months|||mg/g||Standard Deviation|Mean
41425|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||12 months|||mg/g||Standard Deviation|Mean
41426|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||6 months|||mg/g||Standard Deviation|Mean
41427|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||Baseline|||mg/g||Standard Deviation|Mean
41428|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months|||mmHg||Standard Deviation|Mean
41429|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months|||mmHg||Standard Deviation|Mean
41443|NCT01438177|Secondary|Median Duration of Response of This Regimen|Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).|up to 2 years|patients who have responded||months||Full Range|Median
41444|NCT01438177|Secondary|Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy||until clinical response (up to 2 years)||||||
41445|NCT01438177|Secondary|Number of Participants With Adverse Events of Grade 3 or Higher|Adverse events reported here were at least possibly related to the protocol therapy.|Treatment period plus 30 days post-treatment|Any patients who started the treatment||participants|||Number
41446|NCT01438177|Primary|Response Rate (CR + PR After 2 Cycles)|"Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:~CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h"|Up to 2 years|Evaluable patients.||percentage of participants|||Number
41447|NCT01438151|Primary|Remicade Dose Escalation|At visit 1 and 2, Remicade given at 5mg/kg. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.|2/16/12-3/22/13|||participants|||Number
41448|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 140 to Week 328|Participants in France who completed the 130-week open-label extension phase and continued beyond Week 140 were included in safety sample.||Participants|||Number
41449|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.||Participants|||Number
41450|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.||Participants|||Number
41451|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.||Participants|||Number
41452|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.||Participants|||Number
41453|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.||Participants|||Number
41454|NCT01438060|Secondary|Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||units on a scale||Standard Error|Mean
41463|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.||Participants|||Number
41455|NCT01438060|Secondary|Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on Scale||Standard Error|Mean
41456|NCT01438060|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase|"AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on Scale||Standard Error|Mean
41457|NCT01438060|Secondary|Clinical Global Impression (CGI) Improvement Score During Extension Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on Scale||Standard Error|Mean
41458|NCT01438060|Secondary|Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values~Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."||Units on a Scale||Standard Error|Mean
41459|NCT01438060|Secondary|Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants who were evaluated for electrocardiogram||Participants|||Number
41460|NCT01438060|Secondary|Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for vital signs||Participants|||Number
41461|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline.|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for laboratory findings||Participants|||Number
41462|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.||Participants|||Number
48608|NCT01337297|Secondary|Intensity of the Urge to the Use of Crack-cocaine|The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.|before and after ERP in two weekly sessions over two weeks||||||
41464|NCT01438060|Secondary|Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"Observed cases data set, efficacy sample. n=Participants with both post-baseline and baseline measures.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Unit on scale||95% Confidence Interval|Mean
41465|NCT01438060|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase|"The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|Baseline (Day 0), Weeks 2, 4, 8, and 10|"Observed Cased data set, efficacy sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on scale||95% Confidence Interval|Mean
41466|NCT01438060|Secondary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline (Day 0), Weeks 2, 4, and 10|"Observed cases data set, Efficacy Sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on scale||95% Confidence Interval|Mean
41467|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41468|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41469|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41470|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41494|NCT01437878|Secondary|Change in Oxygen Uptake Per Heartbeat|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41471|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41472|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41473|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41474|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41475|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41476|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41477|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41495|NCT01437878|Secondary|Change in Carbon Dioxide Output|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41478|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41479|NCT01438060|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline (Day 0), Week 10|"LOCF data set, efficacy sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on Scale||Standard Error|Mean
41480|NCT01438060|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase|"The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.~A negative change score signifies improvement."|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Unit on Scale||95% Confidence Interval|Mean
41481|NCT01438060|Secondary|CGI Improvement Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on Scale||Standard Error|Mean
41482|NCT01438060|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2). An additional participant did not have CGI-Severity score and was not included in the analysis"||Units on Scale||95% Confidence Interval|Mean
41483|NCT01438060|Secondary|Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41484|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Unit on a Scale||95% Confidence Interval|Mean
41496|NCT01437878|Secondary|Change in Oxygen Uptake|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
49422|NCT01328756|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||mmHg||Standard Deviation|Mean
41485|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Participants|||Number
41486|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Participants|||Number
41487|NCT01438060|Secondary|Change From Baseline in NPI Total Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a Scale||95% Confidence Interval|Mean
41488|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on Scale||95% Confidence Interval|Mean
41489|NCT01438060|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Week 10|"Last Observation Carried forward (LOCF) data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"||Units on a scale||Standard Error|Mean
41490|NCT01437878|Secondary|Change in Minute Ventilation|Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41491|NCT01437878|Secondary|Change in Tidal Volume|Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41492|NCT01437878|Secondary|Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry|Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41493|NCT01437878|Secondary|Change in Heart Rate|Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41548|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||6 months|||percent||Standard Deviation|Mean
41549|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||30 days|||percent||Standard Deviation|Mean
41497|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Oxygen|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41498|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Carbon Dioxide|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41499|NCT01437878|Secondary|Change in Pulmonary Vascular Resistance|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41500|NCT01437878|Secondary|Change in Right Ventricular Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41501|NCT01437878|Secondary|Change in Cardiac Output|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41502|NCT01437878|Secondary|Change in Mean Right Atrial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41503|NCT01437878|Secondary|Change in Mean Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41504|NCT01437878|Secondary|Change in Diastolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41505|NCT01437878|Secondary|Change in Systolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41506|NCT01437878|Secondary|Participants With Treatment-emergent Adverse Events|Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks|Baseline up to 24 hours post-EOT, approximately 4 weeks|Total population||participants|||Number
41507|NCT01437878|Primary|Change in Endurance Time|Change from baseline to week 4 in endurance time during constant work rate exercise testing|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.|||||
41508|NCT01437501|Secondary|Change From Baseline in Levels of Glucoraphanin/Sulforaphane and Their Metabolites Over Intervention Period||Endpoints assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12.||01/2014||||
41509|NCT01437501|Primary|Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period|Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks|Endpoints were assessed on urine samples collected at the end of the intervention on week 12.|Analyses were conducted on all urine samples provided by study participants at week 12.||pmol/mg creatinine||Inter-Quartile Range|Median
41604|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban After Three Days of 50 mg IV Daily in HRS Type 1 Patients||3 days|||hours||Standard Deviation|Mean
41605|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban Acylglucuronide After Three Days of 15 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41510|NCT01437423|Other Pre-specified|Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.|The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported.|Up to 30 days post-primary and booster of vaccination|Adverse events were reported from the Safety Analysis Set.||Participants|||Number
41511|NCT01437423|Other Pre-specified|Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unsolicited adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 year surveillance period|Up to 30 days post-primary and booster of TETRAXIM™ vaccination|Unsolicited adverse events were reported from the Safety Analysis Set.||Participants|||Number
41512|NCT01437423|Other Pre-specified|Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours.|Up to 30 days post-primary and booster vaccination|Solicited adverse events were reported from the Safety Analysis Set.||Participants|||Number
41513|NCT01437423|Primary|Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period.|Up to 30 days post-primary and booster vaccination|Adverse events were reported from the Safety Analysis Set.||Participants|||Number
41514|NCT01437319|Primary|Corneal Infiltrate Event- Phase II|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|12-Month Follow-up|The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification.||percentage of subjects|||Number
41515|NCT01437319|Primary|Corneal Infiltrate Events - Phase I|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|1-Month Follow-up|The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective.||percentage of subjects|||Number
41516|NCT01437267|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population||participants|||Number
41517|NCT01437267|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
41518|NCT01437267|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
41519|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set||percentage of subjects||95% Confidence Interval|Number
41520|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.||percentage of subjects||95% Confidence Interval|Number
41521|NCT01437124|Secondary|Chromosomal Abnormality|Deviation of karyotype from normal 2 years post THR|2 years post THR|24 colour FISH||% chromosomal abberations||95% Confidence Interval|Mean
41522|NCT01437124|Primary|Cobalt Chromium Levels|Serum cobalt chromium levels post THR|2 years post THR|metal ion levels||micrograms/dl||95% Confidence Interval|Mean
41523|NCT01437111|Secondary|Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26|Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.|Baseline and Week 26|Per Protocol Population consisted of FAS but excluded participants who had important deviations from protocol or did not complete study on study drug. For analysis, participants in Per Protocol Population were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve.||Percent change||Standard Deviation|Mean
41524|NCT01437111|Primary|Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26|Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.|Week 26|Full Analysis Set (FAS) consisted of participants who received >=1 dose of study drug; had >=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve||Participants|||Number
41525|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 36 Months|||Points||Inter-Quartile Range|Median
41606|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban Acylglucuronide After Three Days of 15 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
41526|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 24 Months|||Points||Inter-Quartile Range|Median
41527|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 12 months|||Points||Inter-Quartile Range|Median
41528|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 6 months|||Points||Inter-Quartile Range|Median
41529|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 30 days|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Q of L available at this visit were analyzed. Not everyone followed to this visit had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||Points||Inter-Quartile Range|Median
41530|NCT01437098|Secondary|Valve-related Deaths||0 day to 36 months|||prob of freedom from event @ 1095 days|||Number
41531|NCT01437098|Secondary|Valve-related Deaths||0 day to 24 months|||prob of freedom from event @ 730 days|||Number
41532|NCT01437098|Secondary|Valve-Related Deaths||0 day to 12 months|||prob of freedom from event @ 365 days|||Number
41533|NCT01437098|Secondary|Valve-related Deaths||0 day to 6 months|||prob of freedom from event @ 183 days|||Number
41534|NCT01437098|Secondary|Valve-related Deaths||0 day to 30 days|||prob of freedom from event @ 30 days|||Number
41535|NCT01437098|Secondary|Repeat Hospitalization||0 day to 36 months|||prob of freedom from event @ 1095 days|||Number
41536|NCT01437098|Secondary|Repeat Hospitalization||0 day to 24 months|||prob of freedom from event @ 730 days|||Number
41537|NCT01437098|Secondary|Repeat Hospitalization||0 day to 12 months|||prob of freedom from event @ 365 days|||Number
41538|NCT01437098|Secondary|Repeat Hospitalization||0 day to 6 months|||prob of freedom from event @ 183 days|||Number
41539|NCT01437098|Secondary|Repeat Hospitalization||0 day to 30 days|||prob of freedom from event @ 30 days|||Number
41540|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percentage of participants|||Number
41541|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Total AR available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percentage of participants|||Number
41542|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||12 months|||percentage of participants|||Number
41543|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||6 months|||percentage of participants|||Number
41544|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||30 days|||percentage of participants|||Number
41545|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percent||Standard Deviation|Mean
41546|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||percent||Standard Deviation|Mean
41547|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||12 months|||percent||Standard Deviation|Mean
41550|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||cm²||Standard Deviation|Mean
41551|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had EOA measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||cm²||Standard Deviation|Mean
41552|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||12 months|||cm²||Standard Deviation|Mean
41553|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||6 months|||cm²||Standard Deviation|Mean
41554|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||30 days|||cm²||Standard Deviation|Mean
41555|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||mmHg||Standard Deviation|Mean
41556|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had mean gradients available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.||mmHg||Standard Deviation|Mean
41557|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||12 months|||mmHg||Standard Deviation|Mean
41558|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient||6 months|||mmHg||Standard Deviation|Mean
41559|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||30 days|||mmHg||Standard Deviation|Mean
41560|NCT01437098|Secondary|Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.||after procedure or discharge|||percentage of participants|||Number
41561|NCT01437098|Secondary|Device Success as Defined in the Description.|"successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system~correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)~Intended performance of the prosthetic valve (aortic valve area >1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR)~Only one valve implanted in the proper anatomical location"|after procedure or discharge|The AT cohort that went through an index procedure were analyzed for Device Success. Also, all components that went into the success measures had to be non-missing. Therefore n=53.||percentage of participants|||Number
41562|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 36 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event at 1095 days|||Number
41563|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 24 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event at 730 days|||Number
41564|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 12 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event @ 365 days|||Number
41565|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 6 months|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event @ 183 days|||Number
41566|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 30 days|The Kaplan-Meier Method was used to calculate the number.||prob of freedom from event @ 30 days|||Number
41567|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 Months|||percentage of participants|||Number
41568|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 Months|||percentage of participants|||Number
41569|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 Months|||percentage of participants|||Number
41570|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|||percentage of participants|||Number
41571|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|NYHA denominators included deaths (n=2). Taken deaths out, you have n=51 at 30 days.||percentage of participants|||Number
41572|NCT01437098|Primary|Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).|The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.|baseline and 6 months|All subjects implanted with the MDT-2111 device.||percentage of participants|||Number
41573|NCT01436799|Primary|Regional Cerebral Oxygen Satuation (rSO2)|definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)|1, 3, 5, 7, and 9 min after the beach chair position|A power analysis was calculated based on a previous study.14 In each group, 16 patients were needed to detect a mean intergroup difference of 5% in the rSO2 value with a power of 80% and a type I error of 0.05. To compensate for a dropout rate of 20%, 40 patients were included in this study.||percentage of rSO2 (%)||Standard Deviation|Mean
41574|NCT01436643|Primary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|"In this analysis patients with all (serious and non-serious) adverse events, and death were reported.~See Safety Section."|21 weeks|The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant||Participants|||Number
41575|NCT01436526|Secondary|Half-life Associated With the Terminal Slope (t½)|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||hr||Geometric Coefficient of Variation|Geometric Mean
41576|NCT01436526|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||hr||Full Range|Median
41577|NCT01436526|Secondary|Mean Residence Time (MRT)|The mean residence time is the average time that the molecules introduced into the body stay in the body.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||hr||Geometric Coefficient of Variation|Geometric Mean
41607|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban Acylglucuronide After Three Days of 15 mg IV Daily in HRS Type 2 Patients||3 days|||hr||Standard Deviation|Mean
41608|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban Acylglucuronide After Three Days of 15 mg IV Daily in HRS Type 1 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41578|NCT01436526|Secondary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||kg/L||Geometric Coefficient of Variation|Geometric Mean
41579|NCT01436526|Secondary|Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUCnorm is defined as AUC divided by dose per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||kg*hr/L||Geometric Coefficient of Variation|Geometric Mean
41580|NCT01436526|Primary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||µg/L||Geometric Coefficient of Variation|Geometric Mean
41581|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC (0-tn)] is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
41582|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample (AUC is defined as area under the concentration vs. time curve from zero to infinity after single (first) dose).|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
41583|NCT01436500|Secondary|Change in 24-hour Urine Volume||Baseline to Hour 96|||mL||Standard Deviation|Mean
41584|NCT01436500|Secondary|The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements||Day 0 to Day 5|||percent|||Number
41585|NCT01436500|Secondary|Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL||Day 0 through Day 5|||percent|||Number
41586|NCT01436500|Primary|Safety: Day 28 Mortality||28 days|||percent|||Number
41587|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban Acylglucuronide After Three Days of 150 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41588|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban Acylglucuronide After Three Days of 150 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
41589|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban Acylglucuronide After Three Days of 150 mg IV Daily in HRS Type 2 Patients||3 days|||hours||Standard Deviation|Mean
41590|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban After Three Days of 150 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41591|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban After Three Days of 150 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
41592|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban After Three Days of 150 mg IV Daily in HRS Type 2 Patients||3 days|||hours||Standard Deviation|Mean
41593|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban Acylglucuronide After Three Days of 50 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41594|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban Acylglucuronide After Three Days of 50 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
41595|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban Acylglucuronide After Three Days of 50 mg IV Daily in HRS Type 2 Patients||3 days|||hours||Standard Deviation|Mean
41596|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban Acylglucuronide After Three Days of 50 mg IV Daily in HRS Type 1 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41597|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban Acylglucuronide After Three Days of 50 mg IV Daily in HRS Type 1 Patients||3 days|||ng/mL||Standard Deviation|Mean
41598|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban Acylglucuronide After Three Days of 50 mg IV Daily in HRS Type 1 Patients||3 days|||hours||Standard Deviation|Mean
41599|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban After Three Days of 50 mg IV Daily in HRS Type 2 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41600|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban After Three Days of 50 mg IV Daily in HRS Type 2 Patients||3 days|||ng/mL||Standard Deviation|Mean
41601|NCT01436500|Primary|Pharmacokinetic Parameters (Time) of Ifetroban After Three Days of 50 mg IV Daily in HRS Type 2 Patients||3 days|||hours||Standard Deviation|Mean
41602|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban After Three Days of 50 mg IV Daily in HRS Type 1 Patients||3 days|||ng*hr/mL||Standard Deviation|Mean
41603|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban After Three Days of 50 mg IV Daily in HRS Type 1 Patients||3 days|||ng/mL||Standard Deviation|Mean
41629|NCT01436435|Secondary|Major Adverse Events (MAE)|Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||Major Adverse Events|||Number
41630|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable.||percentage of patients|||Number
41631|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable.||percentage of patients|||Number
41632|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.||percentage of patients|||Number
41633|NCT01436435|Secondary|Procedural Success|Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy|Index Procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of patients|||Number
41634|NCT01436435|Primary|Binary Restenosis|Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable.||percentage of patients|||Number
41635|NCT01436370|Secondary|Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.||participants|||Number
41636|NCT01436370|Secondary|Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2011-2012 vaccines.||participants|||Number
41637|NCT01436370|Secondary|Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire|The RAPID 3 score is an index of the three patient-reported measures from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) R808 and serves as an assessment of patient status for those with rheumatoid arthritis. The score consists of the cumulative total of the Function (FN), Pain (PN), and Patient Global (PTGL) values. The severity of the RAPID 3 score is categorized as: >12=High Severity; 6.1-12=Moderate Severity; 3.1-6=Low Severity; and ≤3=Remission. The NP2 questionnaire was completed by RA participants at all clinic visits. Scores at Days 7, 21 and 180 were compared to Day 0 to determine worsening, defined as moving from the baseline category to a more severe category.|Day 0 to Days 7, 21 and 180|All RA participants are included in the analysis population for this outcome measure.||participants|||Number
41638|NCT01436370|Secondary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes RA participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose recipient is not included at Day 180 because the participant was out of window.||participants|||Number
41672|NCT01436175|Primary|Change From Baseline in Pulse Rate at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.||beats per minute(bpm)||Standard Deviation|Mean
41839|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41639|NCT01436370|Secondary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes all RA subjects enrolled and vaccinated with the 2011-2012 vaccines.||participants|||Number
41640|NCT01436370|Primary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2012-2013 vaccines.||participants|||Number
41641|NCT01436370|Secondary|Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
41642|NCT01436370|Secondary|Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
41643|NCT01436370|Secondary|Number of Participants Reporting Fever|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
41644|NCT01436370|Secondary|Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, shivering, and asthenia for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
41645|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2012-2013 seasonal inactivated TIV. Within each 2012-2013 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180|The analysis population includes all participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.||titers||95% Confidence Interval|Geometric Mean
41646|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2011-2012 seasonal inactivated TIV. Within each 2011-2012 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180|||titers||95% Confidence Interval|Geometric Mean
41647|NCT01436370|Secondary|Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study.|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 to Day 180|The analysis population includes all participants enrolled and vaccinated in the study.||participants|||Number
41648|NCT01436370|Primary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2011-2012 vaccines.||participants|||Number
41649|NCT01436253|Primary|Percentage of Participants With Reduced Cardiovascular Risk|Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; >=17 total points for men, and >=25 total points for women indicates a >=30% risk of developing cardiovascular disease.|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.||Percentage of participants|||Number
41650|NCT01436253|Primary|Percentage of Participants Achieving Target Lipid Values|Target total cholesterol value was <4.5 mmol/L and target low densisty lipoprotein (LDL) value was <2.5 mmol/L|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
41651|NCT01436201|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Tmax data.||hours||Full Range|Median
41652|NCT01436201|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Cmax data.||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
41653|NCT01436201|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin AUC data.||nanograms times hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
41654|NCT01436175|Secondary|PRUQ-MDD – Effect of Depressive Symptoms|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale – 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories||units on scale||Standard Deviation|Mean
41655|NCT01436175|Secondary|PRUQ-MDD – Number of Hours|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||hours||Standard Deviation|Mean
41656|NCT01436175|Secondary|PRUQ-MDD – Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions – 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories||events||Standard Deviation|Mean
41657|NCT01436175|Secondary|PRUQ-MDD – Number of Days of Resource Utilization|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.||days||Standard Deviation|Mean
41658|NCT01436175|Secondary|Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)|"The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions:~1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is.~Number of participants with response is reported."|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure||participants|||Number
41659|NCT01436175|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Week 53|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
41660|NCT01436175|Secondary|Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET|CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.||units on a scale||Standard Deviation|Mean
49423|NCT01328756|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||mmHg||Standard Deviation|Mean
41661|NCT01436175|Secondary|Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories||units on a scale||Standard Deviation|Mean
41662|NCT01436175|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure||units on a scale||Standard Deviation|Mean
41663|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale|EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
41664|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
41665|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
41666|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
41667|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
41668|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
41669|NCT01436175|Secondary|Short Form-12 Health Survey Version 2 (SF-12V2)|SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
41670|NCT01436175|Secondary|Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)|Participants who did not have Clinical Global Impressions – Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.||participants|||Number
41671|NCT01436175|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET|"Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.~Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162])."|Baseline, Week 52/ET|Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points.||units on a scale||Standard Deviation|Mean
41673|NCT01436175|Primary|Change From Baseline in Diastolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.||mmHg||Standard Deviation|Mean
41674|NCT01436175|Primary|Change From Baseline in Systolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.||millimeter of mercury(mmHg)||Standard Deviation|Mean
41675|NCT01436175|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Week 5 up to Week 52/Early Termination(ET)|Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study||participants|||Number
41676|NCT01436162|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an AE, or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).||Score||Standard Deviation|Mean
41677|NCT01436162|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an adverse event [AE], or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41678|NCT01436162|Secondary|Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI)|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Error|Least Squares Mean
41679|NCT01436162|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41680|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Female subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Deviation|Mean
41681|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Male subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Deviation|Mean
41682|NCT01436162|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41683|NCT01436162|Secondary|Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores|The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||t-score||95% Confidence Interval|Least Squares Mean
42371|NCT01428128|Primary|Decrease in p53 Protein Production|A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.|Day 1 of chemotherapy|||mg/kg|||Number
41684|NCT01436162|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of MADRS total score after the Augmentation Baseline Visit (Visit 8). Sample size (n) of MADRS total score at each visit differed from sample size (N) of the FAS.||units on a scale||95% Confidence Interval|Least Squares Mean
41685|NCT01436162|Secondary|Percent of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41686|NCT01436162|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e. ≥50% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41687|NCT01436162|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e. ≥25% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41688|NCT01436162|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41689|NCT01436162|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41690|NCT01436149|Secondary|Amphetamine Cessation Symptom Assessment (ACSA)|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||Standard Deviation|Mean
41691|NCT01436149|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41692|NCT01436149|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41693|NCT01436149|Secondary|Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41694|NCT01436149|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41726|NCT01435928|Secondary|Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)|Smoking history and frequency were assessed during the study by a research staff member. During the study, smoked subjects were asked about the average number of cigarettes per day they smoked over the last week.|28 Weeks - Double Blind Phase|ITT Subjects who smoked||number of cigarettes smoked daily||Standard Deviation|Mean
49424|NCT01328756|Primary|Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||beats per minute||Standard Deviation|Mean
41695|NCT01436149|Secondary|Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)|The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41696|NCT01436149|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41697|NCT01436149|Secondary|Percentage of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41698|NCT01436149|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41699|NCT01436149|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||percentage of participants|||Number
41700|NCT01436149|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41701|NCT01436149|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).||units on a scale||95% Confidence Interval|Least Squares Mean
41702|NCT01436110|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 24/Early Withdrawal|ITT Population||Participants|||Number
41703|NCT01436110|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
41704|NCT01436110|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
41705|NCT01436110|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
41706|NCT01436110|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
41707|NCT01436110|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
41708|NCT01436084|Primary|Number of Participants With Overall Response|Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still > 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.|28 days to one year|Study was halted prior to completion of treatment and assessment for any participant(s).|||||
41709|NCT01436071|Secondary|Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 12/Early Withdrawal|ITT Population||Participants|||Number
41710|NCT01436071|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
41711|NCT01436071|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
41712|NCT01436071|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
41713|NCT01436071|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
41714|NCT01436071|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
41715|NCT01436045|Primary|Trails B - Errors|The results are presented as the mean sum of the errors during the Trails B assessment For each of these, a higher number of errors is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration|||mean number of errors||Standard Error|Mean
41716|NCT01436045|Primary|Trails B - Seconds|The results are presented as the number of seconds to complete Trails B. For each of these, a higher number of seconds is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration|||mean seconds||Standard Error|Mean
41717|NCT01436045|Secondary|Olfactory Function|"The Sniff Magnitude Test (SMT) measures olfactory function not influenced by cognitive problems (minimal dependence on language, cognitive ability, memory, and odor naming ability). Sniff magnitude ratios are calculated as a ratio of sniff magnitudes (area under the sniff curve). Lower sniff magnitude ratios indicate more impairment.~[average sniff magnitude of malodor/average sniff magnitude to a null odor]"|60 minute post intranasal administration|||ratio of area under the sniff curve||Standard Error|Mean
41718|NCT01436045|Primary|Cognitive Performance|"The results are presented as a mean number of correct responses for each cognitive assessment.~For each of these, a lower number correct is indicative of a higher cognitive deficit.~Ranges are as follows: RBANS List Learning (0-40), RBANS Story Memory (0-24), RBANS Figure Copy (0-20), RBANSLine Orientation (0-20), RBANS Semantic Fluency (0-unlimited), RBANS List Recall (0-10), RBANS List Recognition (0-20), RBANS Story Recall (0-12), RBANS Figure Recall (0-20), Digit Span Forward (0-16), Digit Span Backward (0-16), Boston Naming (0-15)."|20 minutes post-intranasal administration|||mean total correct responses||Standard Error|Mean
41719|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Spine CT Examinations.||one year|||mGy||Standard Deviation|Mean
41720|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest Abdomen and Pelvis CT Examinations.||one year|||mGy||Standard Deviation|Mean
41721|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Cardiac CT Examinations.||one year|||mGy||Standard Deviation|Mean
41722|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations.||one year|||mGy||Standard Deviation|Mean
41723|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest CT Examinations.||one year|||mGy||Standard Deviation|Mean
41724|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Head CT Examinations.||One year|||mGy||Standard Deviation|Mean
41725|NCT01435928|Secondary|Intent to Attend (ITA) Assessment at Open-label Baseline|The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the screening visit: “How likely is it that you will complete the study?”|Open Label Baseline|All subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||units on a scale||Standard Deviation|Mean
43222|NCT01413516|Primary|7 Day Point Prevalence Abstinence From All Forms of Tobacco|Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.|4 weeks after beginning study|||participants|||Number
41727|NCT01435928|Other Pre-specified|EuroQol (EQ-5D): EQ-VAS Score|"The EQ-5D is a self-administered, standardized measure of health states consisting of two parts: EQ-5D descriptive system consisting of one question in each of five dimensions (mobility, self-care, pain, usual activities, and anxiety) with three possible response levels per question, classifying patients into one of 243 distinct health states, and a 20-cm visual analogue health status rating.~The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline assessment.||units on a scale||Standard Deviation|Mean
41728|NCT01435928|Secondary|Brief Adherence Rating Scale|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 - 100%) of doses taken by the subject in the previous month.|Double-blind phase - 28 Weeks|There were 6 Lurasidone subjects and 2 placebo subjects that had no post-baseline assessment.||percentage of monthly doses taken||Standard Deviation|Mean
41729|NCT01435928|Secondary|Change From Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) Total Score|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items divided into two subscales: Social functioning (comprised of 7 items from interpersonal relationships section) and Community Living Skills (comprised of 17 items from activities and work skills sections). Each item is rated on a 5-point scale and mapped to 0 to 4 with a higher score indicating worse condition. The total score will be the sum of all 24 items and ranges from 0 to 96.|Double-blind phase - 28 Weeks|There were 19 Lurasidone subjects and 20 placebo subjects that had no post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
41730|NCT01435928|Secondary|Change From Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score|"The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales.~Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline SF-12 assessment.||units on a scale||Standard Error|Least Squares Mean
41731|NCT01435928|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Double-blind phase - 28 Weeks|There were four Lurasidone subjects and 2 placebo subjects that had no post-baseline MADRS assessment.||units on a scale||Standard Error|Least Squares Mean
41732|NCT01435928|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Double-blind phase - 28 Weeks|||units on a scale||Standard Error|Least Squares Mean
41733|NCT01435928|Secondary|Change From Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three scales: the Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Double-Blind phase - 28 Weeks|||units on a scale||Standard Error|Least Squares Mean
41734|NCT01435928|Secondary|Time to All-cause Discontinuation|The Kaplan-Meier method was used for estimation.|Double-blind phase - 28 weeks|||days||95% Confidence Interval|Median
41735|NCT01435928|Primary|Time to First Relapse Event During Double-blind Phase|The Kaplan-Meier method is used for the estimation.|Double-blind phase - 28 Weeks|||days||95% Confidence Interval|Median
41736|NCT01435759|Primary|Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.|Augmentation Baseline (Week 8) to Week 16|Dose Response Evaluable Set (DRES): All randomized subjects who had at least 1 valid primary efficacy measurement (MADRS total score) during the Dose Maintenance Period (Weeks 11-16) while on the target dose level of investigational product.||units on a scale||90% Confidence Interval|Least Squares Mean
41737|NCT01435759|Secondary|Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.||bpm||Standard Deviation|Mean
41738|NCT01435759|Secondary|Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.||mmHg||Standard Deviation|Mean
41739|NCT01435759|Secondary|Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.||mmHg||Standard Deviation|Mean
41740|NCT01435655|Other Pre-specified|Plasma Concentration of Tafamidis at Week 8, Week 26, Week 52 and Week 78|Mean plasma concentration of tafamidis at 3 hours after administration|Week 8, Week 26, Week 52, Week 78|The PK Analysis Set included all participants treated who had at least 1 quantifiable plasma tafamidis concentration.||ng/mL||Standard Deviation|Mean
41741|NCT01435655|Secondary|Number of Participants With Transthyretin (TTR) Stabilization at Week 26, Week 52, and Week 78 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|TTR tetramer was assessed using a validated immunoturbidimetric assay. The TTR tetramer level for each plasma sample was measured before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the “TTR stabilization” is defined as the patient whose percent stabilization is equal to or more than 32%.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Participants|||Number
41742|NCT01435655|Secondary|Change From Baseline in Ambulatory Status at Week 26, Week 52 and Week 78|Ambulatory status was evaluated using walking ability scale in polyneuropathy disability score. The ambulatory status was evaluated as: 0=Good, 1=Sensory disturbances in the feet but able to walk without difficulty, 2=Some difficulties with walking but can walk without aid, 3a=Able to walk with 1 stick or crutch, 3b=Able to walk with 2 sticks or crutches, 4=Not ambulatory, confined to a wheelchair or bedridden.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Participants|||Number
41743|NCT01435655|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Week 8, Week 26, Week 52 and End of Study|The mBMI was calculated by multiplying the BMI (the weight in kilograms divided by the square of the height in meters) by serum albumin level (gram/liter). Change in mBMI was calculated as the mBMI at the given week minus the Baseline mBMI.|Baseline, Week 8, Week 26, Week 52, End of Study|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
41744|NCT01435655|Secondary|Change From Baseline in Summated 3 Nerve Tests Small Fiber Normal Deviate Score (∑ 3 NTSF Nds) as Measured by Cooling and Heat Pain Thresholds by QST and HRDB at Week 26, Week 52 and Week 78|The Σ3 NTSF nds measures small-fiber function. It is a composite score defined as 3 times the mean of non-missing values of normal deviates of cooling threshold for lower limbs, heat pain intermediate response for lower limbs, and HRDB. The total score range is approximately -11.2 to 11.2, with a higher score demonstrating worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
41745|NCT01435655|Secondary|Change From Baseline in Summated 7 Nerve Tests Normal Deviate Score (∑ 7 NTs Nds) as Measured by Nerve Conduction Studies (NCS), Vibration Detection Threshold (VDT) and Heart Rate Response to Deep Breathing (HRDB) at Week 26, Week 52, and Week 78|The Σ7 NTs nds measures primarily large-fiber function. It is a composite score derived from five NCS attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with VDT obtained in great toes by Quantitative Sensory Testing (QST), and HRDB value. It is defined as 7 times the mean of non-missing values of, the five normal deviates of NCS, HRDB, and average normal deviate for VDT of toes. Score was determined through reference to normal values for age, sex, height and abnormalities scored. Total score range is approximately -26 to 26, where higher score=worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
41746|NCT01435655|Secondary|Change From Baseline in Scores of the Total Quality of Life (TQOL) and 5 Domains as Measured by the Norfolk QOL – Diabetic Neuropathy (Norfolk QOL-DN) at Week 26, Week 52 and Week 78.|Norfolk QOL-DN is a 35-item participant-rated questionnaire. It consists of 5 domains: Physical Functioning/Large Fiber [score range: -4 – 56] , Activities of Daily Living (ADL) [0 - 20], Symptoms [0 - 32], Small Fiber [0 - 16] and Autonomic [0 - 12]. Total of quality of life (TQOL) score is the sum of all five domains with a range of -4 to 136 (Pfizer Data Standards). Higher scores on each item of the Norfolk QOL-DN TQOL indicate worse quality of life.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
41747|NCT01435655|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS); NIS (Total), NIS-LL (Lower Limb) and NIS-UL (Upper Limb) at Week 26, Week 52 and Week 78|The NIS provides a total body single score of neuropathic deficits (score range: 0-122, higher score = more deficit), comprising subset scores for cranial nerves, muscle weakness, reflexes, and sensation (based on mean of 2 scores in 1 week period; each item scored separately for left and right). The NIS-LL is a subscale that provides a score for the lower limbs functions (muscle weakness, reflexes and sensation in great toe) and has a score range of 0-44 (higher score = more deficit). The NIS-UL is a subscale that provides a score for the upper body functions (muscle weakness [including cranial nerves], reflexes and sensation in finger) and has a score range of 0-78 (higher score = more deficit). The components for cranial nerves and muscle weakness are scored from 0 (Normal) to 4 (Paralysis), and those for reflexes and sensation from 0 (Normal) to 2 (Absent). For all items, higher scores indicate greater impairment.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Units on a scale||Standard Deviation|Mean
41760|NCT01435577|Secondary|Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores|Individual participants response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.||participants|||Number
41748|NCT01435655|Primary|Number of Participants With Transthyretin (TTR) Stabilization at Week 8 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|TTR tetramer level for each plasma sample was assessed using a validated immunoturbidimetric assay before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer average concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the “TTR stabilization” is defined as the patient whose percent stabilization is equal to or more than 32%.|8 weeks|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.||Participants|||Number
41749|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data (indicated in brackets)||units on a scale||Standard Deviation|Mean
41750|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data.||units on a scale||Standard Deviation|Mean
41751|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol-O-glucuronide|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL."|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.||ng/mL||Full Range|Mean
41752|NCT01435577|Post-Hoc|Number of Participants Scored as a Responder Based on Patient Global Impression of Change|Responders are those participants with Patient Global Impression of Change (PGIC) values “Much improved”, or “Very much improved”. Participants with missing value are considered non-responders.|Fixed time points at 12, 24 and 48 hours after baseline|Participants with early second dose the PGIC assessment from End-of-double-blind Treatment was taken as the 48 hours value. Assessments done more than 4.5 hours after the 12th infusion were excluded from analysis and participants were considered non-responders.||participants|||Number
41753|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol|Tapentadol concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.||ng/mL||Full Range|Mean
41754|NCT01435577|Secondary|Time to Meaningful Pain Relief|The participant was instructed to stop the stopwatch when they had meaningful pain relief. That is, when the pain relief made a real difference, after the first drug administration.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time in hours to meaningful pain relief are not reported for matching placebo arm due to the high discontinuation rate.||hours||95% Confidence Interval|Median
41755|NCT01435577|Secondary|Time to Perceptible Pain Relief|When the participant began to feel any pain-relieving effect after the administration of the first dose they were requested to stop the first stopwatch. The time was noted. This measured when the participant first felt any difference in the pain.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time to perceptible pain relief is not reported for matching placebo arms because of the high number of discontinuations.||hours||95% Confidence Interval|Median
41756|NCT01435577|Secondary|Time to First Rescue Medication|The median time to first rescue medication intake (600 mg ibuprofen) in hours.|up to 48 hours|Full analysis set.||hours||95% Confidence Interval|Median
41757|NCT01435577|Secondary|Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.||participants|||Number
41758|NCT01435577|Secondary|Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.||participants|||Number
41759|NCT01435577|Secondary|Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.||participants|||Number
41840|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41761|NCT01435577|Secondary|Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.||participants|||Number
41762|NCT01435577|Secondary|Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.||participants|||Number
41763|NCT01435577|Secondary|Sum of Pain Intensity Differences After 48 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 48 hours after first study drug administration|Full Analysis Set.||units on a scale||95% Confidence Interval|Mean
41764|NCT01435577|Secondary|Sum of Pain Intensity Differences After 12 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 12 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 12 hours after first study drug administration|Full Analysis Set.||units on a scale||95% Confidence Interval|Mean
41765|NCT01435577|Secondary|Sum of Pain Intensity Differences After 8 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 8 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 8 hours after first study drug administration|Full Analysis Set.||units on a scale||95% Confidence Interval|Mean
41766|NCT01435577|Secondary|Sum of Pain Intensity Differences After 4 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 4 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 4 hours after first study drug intake|Full analysis set. Primary imputation method was analyzed: Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 h after each rescue medication intake.||units on a scale||95% Confidence Interval|Mean
41767|NCT01435577|Secondary|Sum of Pain Intensity Differences After 60 Minutes|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the value is negative then the baseline pain intensity was greater than the pain intensity measured after dosing.|Baseline value to 60 minutes after first study drug administration|Full analysis set.||units on a scale||95% Confidence Interval|Mean
41768|NCT01435577|Secondary|Patient Global Impression of Change After 48 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 48 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.||participants|||Number
41769|NCT01435577|Secondary|Patients Global Impression of Change After 24 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 24 hours after study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.||participants|||Number
41770|NCT01435577|Secondary|Patient Global Impression of Change After 12 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 12 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.||participants|||Number
41771|NCT01435577|Secondary|Pain Intensity Differences at Fixed Time Points|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline pain intensity (prior to the first dose) and the pain intensity at the time. A negative number indicates a decrease in pain in the whole treatment group. The greater the negative pain intensity difference value the greater the pain relief in the treatment arm. A score of 0 indicates that there has been no change in pain in a treatment group. A positive value indicates an increase in pain in the treatment group.|Starting at 15 minutes and up to 48 hours after first drug administration|Full Analysis Set (FAS): Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.||units on a scale||Standard Deviation|Mean
41772|NCT01435577|Secondary|Mean Pain Intensity Scores at Fixed Time Points|The mean pain intensity at fixed time points in the trial for all participants is listed. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; up to 48 hours|Full Analysis Set (FAS). Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.||units on a scale||Standard Deviation|Mean
41773|NCT01435577|Primary|Sum of Pain Intensity Differences (SPID 24)|"Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline."|Baseline value; up to 24 hours after first study drug administration|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.||units on a scale||95% Confidence Interval|Least Squares Mean
41774|NCT01435460|Secondary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
41775|NCT01435460|Secondary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
41776|NCT01435460|Primary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
41777|NCT01435460|Primary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population||units on a scale||Standard Deviation|Mean
41778|NCT01435265|Secondary|Adherence to Adalimumab Treatment|Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.|Baseline to 12 months|All participants||days||Standard Deviation|Mean
41779|NCT01435265|Primary|Investigator's Global Assessment (IGA) of Psoriasis|Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).|12 months|All participants completing the study.||participants|||Number
41780|NCT01435265|Primary|Change in Psoriasis Area Severity Index (PASI-75)|The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.|Baseline, 1 month, 3 months, 6 months, 9 months, 12 months|All participants who completed the study.||participants|||Number
41781|NCT01435174|Secondary|QT Interval|Calculation of the QT interval after receiving a single-dose of ranolazine|At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30||||||
41782|NCT01435174|Primary|Pharmacokinetic Parameters of Ranolazine|Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine|At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65|||mcg/mL||Standard Deviation|Mean
41783|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|5 years||||||
41784|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|4 years||||||
41785|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|3 years||||||
41786|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|2 years||||||
41787|NCT01435031|Secondary|Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants|||Number
41788|NCT01435031|Primary|Angioplasty Predilatation-related: Successful Predilatation of the CTO|"Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and;~Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and;~Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and;~Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|Angiographically Evaluable Subjects||percentage of participants||95% Confidence Interval|Number
41789|NCT01435031|Primary|Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)|"Successful recanalization of the CTO defined as:~Confirmation of placement of the guide wire in the distal true lumen (component 1)~Absence of in-hospital MACE, based on protocol MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.||percentage of participants||95% Confidence Interval|Number
41790|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|5 years||||||
41791|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|4 years||||||
41792|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|3 years||||||
41793|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|2 years||||||
41794|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41795|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|very late (>1 year)||||||
41796|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Late (>30 days to 1 year)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41797|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Subacute (>24 hours to 30 days)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41815|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|3 years||||||
41816|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|2 years||||||
41798|NCT01435031|Secondary|Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Acute (0-24 hours)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41799|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|5 years||||||
41800|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|4 years||||||
41801|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|3 years||||||
41802|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|2 years||||||
41803|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41804|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41805|NCT01435031|Secondary|Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41806|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|5 years||||||
41807|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|4 years||||||
41808|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|3 years||||||
41809|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|2 years||||||
41810|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41811|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41812|NCT01435031|Secondary|Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41813|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|5 years||||||
41814|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|4 years||||||
41817|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41818|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41819|NCT01435031|Secondary|Clinically-Driven Target Vessel Revascularization (Clinically-Driven TVR)|Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41820|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|5 years||||||
41821|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|4 years||||||
41822|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|3 years||||||
41823|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|2 years||||||
41824|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41825|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41826|NCT01435031|Secondary|Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41827|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|5 years||||||
41828|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|4 years||||||
41829|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|3 years||||||
41830|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|2 years||||||
41831|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41832|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41833|NCT01435031|Secondary|Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41834|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|5 years||||||
41835|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|4 years||||||
41836|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|3 years||||||
41837|NCT01435031|Secondary|Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|2 years||||||
41845|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41846|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41847|NCT01435031|Secondary|Target Vessel-related MI|"TLF Component; per protocol~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41848|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)~Q wave MI: development of new, pathological Q wave on the ECG~Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|5 years||||||
41849|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)~Q wave MI: development of new, pathological Q wave on the ECG~Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|4 years||||||
41850|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)~Q wave MI: development of new, pathological Q wave on the ECG~Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|3 years||||||
41851|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)~Q wave MI: development of new, pathological Q wave on the ECG~Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|2 years||||||
41852|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)~Q wave MI: development of new, pathological Q wave on the ECG~Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41853|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol. Myocardial Infarction (Protocol Definition)~Q wave MI: development of new, pathological Q wave on the ECG~Non-Q-wave MI: elevation of CK levels to ≥ 2 x ULN with elevated CK-MB in the absence of new pathological Q waves"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41854|NCT01435031|Secondary|Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component; per protocol~Myocardial Infarction (Protocol Definition)~Q wave MI: development of new, pathological Q wave on the ECG~Non-Q-wave MI: elevation of CK levels to ≥ 2 x upper limit of normal (ULN) with elevated Creatine kinase myocardial-band isoenzyme (CK-MB) in the absence of new pathological Q waves"|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41855|NCT01435031|Secondary|Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|5 years||||||
41856|NCT01435031|Secondary|Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|4 years||||||
41857|NCT01435031|Secondary|Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|3 years||||||
41858|NCT01435031|Secondary|Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|2 years||||||
41859|NCT01435031|Secondary|Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|1 year|ITT set||percentage of participants||95% Confidence Interval|Number
41860|NCT01435031|Secondary|Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41861|NCT01435031|Secondary|Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41862|NCT01435031|Secondary|Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|5 years||||||
41863|NCT01435031|Secondary|Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|4 years||||||
41864|NCT01435031|Secondary|Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|3 years||||||
41865|NCT01435031|Secondary|Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|2 years||||||
41866|NCT01435031|Secondary|Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41867|NCT01435031|Secondary|Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41868|NCT01435031|Secondary|Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41869|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|5 years||||||
41870|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|4 years||||||
41871|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|3 years||||||
41872|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|2 years||||||
41873|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41874|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41875|NCT01435031|Secondary|Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|30 days|ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
42672|NCT01423617|Secondary|Subjects' Global Feeling of Satiety|Subject’s feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = ”no”; 1 = ”slightly”, 2 = ”moderate” and 3 = ”strong”.|12 weeks||||||
41876|NCT01435031|Secondary|Clinically Significant Perforation|Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT.The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41877|NCT01435031|Secondary|Resource Utilization: Contrast Volume||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||mL||Standard Deviation|Mean
41878|NCT01435031|Secondary|Resource Utilization: Fluoroscopic Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Minutes||Standard Deviation|Mean
41879|NCT01435031|Secondary|Resource Utilization: Procedural Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||Minutes||Standard Deviation|Mean
41880|NCT01435031|Secondary|Procedural Success With Multiple Crossing Techniques|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41881|NCT01435031|Secondary|Procedural Success With Sub Intimal Technique|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41882|NCT01435031|Secondary|Procedural Success With Kissing Wire Technique|per protocol; combined antegrade and retrograde crossing method|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41883|NCT01435031|Secondary|Procedural Success With Reverse CART|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41884|NCT01435031|Secondary|Procedural Success With Controlled Antegrade-Retrograde Technique (CART)|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41885|NCT01435031|Secondary|Procedural Success With Primary Retrograde Wire Crossing|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41886|NCT01435031|Secondary|Procedural Success With Knuckle Wire|per protocol; antegrade crossing method|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41887|NCT01435031|Secondary|Procedural Success With STAR Technique|"per protocol; antegrade crossing method~STAR is Subintimal Tracking and Re-entry technique."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41888|NCT01435031|Secondary|Procedural Success With Antegrade Crossing|per protocol|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.||percentage of participants|||Number
41889|NCT01435031|Secondary|Procedure Success|"Device success and absence of in-hospital MACE.~Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).~Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41890|NCT01435031|Secondary|Device Success|Achievement of <50% diameter stenosis within the target lesion segment using assigned study device|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41910|NCT01434823|Secondary|Re-admission to the MICU Within 48 Hours|The investigators will measure, in hours, the time spent from discharge from the MICU until a patient is re-admitted to the MICU during the same hospital stay.|From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months|||participants|||Number
41911|NCT01434823|Secondary|In-hospital Mortality|Mortality will be assessed during each patient's stay in the hospital.|From time of admission to MICU to hospital discharge - assessed up to 12 months|||participants|||Number
41912|NCT01434823|Secondary|MICU Mortality|Mortality will be assessed during each patient's stay in the MICU from admission to discharge|From time of admission to MICU until discharge from MICU - assessed up to 12 months|||participants|||Number
41891|NCT01435031|Secondary|Change in TIMI Flow Grade: Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~TIMI Classification:~TIMI 0 No perfusion.~TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.~TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.~TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41892|NCT01435031|Secondary|Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~TIMI Classification:~TIMI 0 No perfusion.~TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.~TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.~TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.||percentage of participants||95% Confidence Interval|Number
41893|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment – in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||mm||Standard Deviation|Mean
41894|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment – in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.||mm||Standard Deviation|Mean
41895|NCT01435031|Primary|Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)|"Successful recanalization of the CTO defined as:~Confirmation of placement of the guide wire in the distal true lumen (component 1)~Absence of in-hospital MACE, based on ARC MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.||percentage of participants||95% Confidence Interval|Number
41896|NCT01435031|Primary|Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.||percentage of participants|||Number
41897|NCT01435031|Primary|Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.||percentage of participants|||Number
41898|NCT01434823|Secondary|Duration of Rounds for Daytime Intensivist|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
41899|NCT01434823|Secondary|Total Number of Calls Per Night for Daytime Intensivist|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
41900|NCT01434823|Secondary|Daytime Intensivist Hours Worked Per Week (Inclusive of Home Call)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Weekly||||||
41901|NCT01434823|Secondary|Daytime Intensivist Hours Worked Per Week (Without Home Call)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Weekly||||||
41902|NCT01434823|Secondary|Daytime Intensivist False Starts (on Vigilance Testing)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily on Weekdays||||||
41903|NCT01434823|Secondary|Daytime Intensivist Lapses in Attention (on Vigilance Testing)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily on Weekdays||||||
41904|NCT01434823|Secondary|Reaction Time of Daytime Intensivists (on Vigilance Testing)|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily on Weekdays||||||
41905|NCT01434823|Secondary|Maximal Uninterrupted Sleep Duration for Daytime Intensivists|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
41906|NCT01434823|Secondary|Number of Interruptions Per Night for Daytime Intensivists|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
41907|NCT01434823|Secondary|Daytime Intensivist Sleep Efficiency|This will be a secondary outcome of the Intensivist Sleep and Work sub-study.|Daily||||||
41914|NCT01434693|Primary|Incidence of Adverse Events|Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms|6 mo|All patients who were randomized were treated according to the protocol and therefore were all included in the Safety Population.||events|||Number
41915|NCT01434680|Secondary|Number Of Subjects Reporting Solicited Local And Systemic Adverse Events|"Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV.~Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS."|From day 1 through day 7|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
41916|NCT01434680|Secondary|Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set.||Titers||95% Confidence Interval|Geometric Mean
41917|NCT01434680|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
41918|NCT01434654|Secondary|Cerebrospinal Fluid|To measure plateaux CSF ARV concentrations. This will identify the proportion of patients achieving levels of specific ARVs capable of inhibiting 95% of in vitro viral replication (IC95).|Baseline to 12 Months|Data presented for n=5 participants with detectable CSF ARV concentrations who had lumbar puncture at Baseline and 12 months. The pre-specified analysis was not conducted as nevirapine, raltegravir, and darunavir were the only ARVs detected in CSF, and of these, only nevirapine was detected above the minimum threshold (set at >50 ug/L).||ug/L||Standard Error|Mean
41919|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H20 as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.||Ratio||Standard Error|Least Squares Mean
41920|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), after a 12 month period of observation. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echo time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.||Ratio||Standard Error|Least Squares Mean
41921|NCT01434654|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, after a 12-month period of observation, between HIV positive patients taking antiretroviral regimens categorized as being either of high or low CNS penetration. To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, Standard Deviation=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Change from baseline Neuropsychological testing at 6 and 12 months|Modified intent-to-treat analysis. All enrolled participants were included aside n=2 low CNS penetrance with baseline data only (1 lost to follow-up, 1 withdrew before 6-months).||Global neurocognitive z-score||Standard Error|Least Squares Mean
41922|NCT01434641|Secondary|Rest/Stress Myocardial Count Density Ratio|"The rest and stress myocardial count densities are determined automatically using Evolution software on the GE Healthcare Xeleris Nuclear Medicine computer workstation. The ratio is calculated by simple division.~Please not that patient outcomes are NOT measured in this research protocol."|immediately following SPECT image processing (1 hour after the test)||||||
41923|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 16 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 16- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 16 minutes|Of the total 102 patients enrolled, additional 16-minute post-stress SPECT was performed on 37 patients.||participants|||Number
41924|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 12 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 12- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 12 minutes|||participants|||Number
42673|NCT01423617|Secondary|Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)||12 weeks||||||
41925|NCT01434511|Secondary|Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41926|NCT01434511|Secondary|Anti-OBI-1 Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41927|NCT01434511|Secondary|Anti-human Factor VIII Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41928|NCT01434511|Secondary|Efficacy Assessment of OBI-1 in Participants With Anti-human Factor VIII Titers >30 Bethesda Units (BU)||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41929|NCT01434511|Secondary|Recovery and Elimination Rate Parameters of OBI-1 in Subjects With Inhibitors Treated With OBI-1 Therapy.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41930|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers and the Recovery of OBI-1.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41931|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode.||Frame: Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41932|NCT01434511|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41933|NCT01434511|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41934|NCT01434511|Secondary|Total Dose of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41935|NCT01434511|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41936|NCT01434511|Secondary|Proportion of Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41937|NCT01434511|Secondary|Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41953|NCT01433549|Secondary|Mean Non-Invasive Tear Film Break-Up Time (NITBUT)|As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.|Hour 12|All participants who participated in both phases of the study.||Seconds||Standard Deviation|Mean
41938|NCT01434511|Primary|Proportion of Serious Bleeding Episodes Responsive to OBI-1|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, the study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within the OBI-1-302 study (Congenital Hemophilia A).|24 hours after initiation of treatment|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).|||||
41939|NCT01434121|Secondary|Plasma Cytokine/Chemokine Levels||during time of infusions - 96 hours from time of enrollment||||||
41940|NCT01434121|Secondary|Multiple Organ Dysfunction Score||during time of infusion - 96 hours from time of enrollment||||||
41941|NCT01434121|Secondary|Length of Time on Vasopressor Medication||during time of infusion - 96 hours from time of enrollment||||||
41942|NCT01434121|Secondary|Ventilator-free Days||subject will be followed until discharged from the hospital, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first||||||
41943|NCT01434121|Secondary|Duration of Mechanical Ventilation||subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 28 days from time of enrollment, whichever is first||||||
41944|NCT01434121|Secondary|Intensive Care Unit Length of Stay||subject will be followed until discharged from the ICU, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first||||||
41945|NCT01434121|Primary|Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients|There were no instances of arterial hypotension, vomiting, or tachycardia within the study population related to the study drug|during time of infusion- 96 hours from time of enrollment|||participants|||Number
41946|NCT01434030|Secondary|Willingness to Follow PGASystem Advice|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would follow this type of advice from a PGASystem.|2 hour focus group|||percentage of participants|||Number
41947|NCT01434030|Primary|Desire to Receive Advice From Personal Glucose Advisory System (PGASystem)|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would like to receive this type of information from a PGASystem.|2 hour focus group|||percentage of participants|||Number
41948|NCT01433913|Secondary|Comparison of Changes in Serum PSA, Fasting Glucose, Fasting Insulin, IGF-1/IGFBP-3, Testosterone, and SHBG Between Study Groups as Assessed by Liquid Chromatography-tandem Mass Spectrometry Assay|Changes in a serum biomarker (from baseline to post-intervention) and secondary tissue endpoints will be compared between intervention groups using a t-test. If the distributions are not normally distributed, a non-parametric rank-sum test will be utilized. Correlations among the biomarkers and between postintervention metformin levels and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients). Plasma levels of metformin will also be compared between groups using a t-test and the correlation of plasma and prostate tissue levels will be examined.|Baseline and 12 weeks||||||
41949|NCT01433913|Secondary|Comparison of Apoptosis (Cleaved Caspase 3), Angiogenesis (CD34), AMPK Activation (p-AMPK), mTOR Regulation (p-p70S6K), Cell Cycle Regulation (Cyclin D1and p-pRb) in the Prostatectomy Tissue Between Study Groups as Assessed by IHC|Changes in a serum biomarker (from baseline to post-intervention) and secondary tissue endpoints will be compared between intervention groups using a t-test. If the distributions are not normally distributed, a non-parametric rank-sum test will be utilized. Correlations among the biomarkers and between postintervention metformin levels and changes in biomarker levels, will be explored (using Pearson or Spearman Rank correlation coefficients). Plasma levels of metformin will also be compared between groups using a t-test and the correlation of plasma and prostate tissue levels will be examined.|12 weeks||||||
41950|NCT01433913|Secondary|Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry|Descriptive statistics will be performed on prostate tissue metformin concentrations within each intervention group. Little if any metformin is expected in the placebo group. Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. The means (and 95% confidence intervals) and distribution of actual values will be reported. Linear regression will be performed to the post-intervention metformin concentration levels to adjust for demographics and duration on intervention. Logistic regression will also be performed.|12 weeks||||||
41951|NCT01433913|Primary|Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)|Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. If the data are not normally distributed, a non-parametric rank-sum test will be utilized.|12 weeks|Participants with tissue sections available from prostatectomy||% positively stained nuclei||Standard Deviation|Mean
41952|NCT01433731|Primary|Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)|Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% – 99% decrease in CAILS score; Stable Disease (SD): < 25% increase to < 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.|Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42|||percentage of participants|||Number
41954|NCT01433549|Primary|Mean End-of-Day Comfort|As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.|Hour 12|All participants who participated in both phases of the study.||Units on a scale||Standard Deviation|Mean
41955|NCT01433471|Secondary|Change From Baseline of the Simple Clinical Colitis Activity Index at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 Weeks|To assess ulcerative colitis disease activity without requiring endoscopy|Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
41956|NCT01433471|Secondary|Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks|To assess ulcerative colitis disease activity|Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
41957|NCT01433471|Primary|Change From Baseline of Gene Expression at 12 Weeks and 24 Weeks as Assessed by Microarray and Real-time Polymerase Chain Reaction Analysis of Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
41958|NCT01433471|Primary|Change From Baseline of Bacterial Composition and Attachment at 12 Weeks and 24 Weeks as Assessed by Real-time Polymerase Chain Reaction and 454 Sequencing of Pinch Biopsies and Stool Specimens||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
41959|NCT01433471|Primary|Change From Baseline of Effector Lymphocyte Populations (Th1, Th2, Th17, and T-regulatory Cells) at 12 and 24 Weeks as Assessed by Flow Cytometry of Peripheral Blood Mononuclear Cells and Isolated Leukocytes From Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
41960|NCT01433471|Primary|Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.|||||
41961|NCT01433354|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which participants entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study.~AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 participants are shown under ‘Prior to Ext. first dose’.~AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated."|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.||participants|||Number
41962|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in time (minutes)||Standard Deviation|Mean
41963|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in time (minutes)||Standard Deviation|Mean
41964|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in time (minutes)||Standard Deviation|Mean
41965|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||percentage change in number of steps||Standard Deviation|Mean
42674|NCT01423617|Secondary|Changes in Body Fat Content (%)||12 weeks||||||
42675|NCT01423617|Secondary|Changes in Waist-hip-ratio||12 weeks||||||
42676|NCT01423617|Secondary|Changes in Hip Circumference||12 weeks|||cm||Standard Deviation|Mean
41966|NCT01433263|Secondary|Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8||Percentage Change in BMD||Standard Deviation|Mean
41967|NCT01433263|Secondary|Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8|total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8||Percentage Change in LBM||Standard Deviation|Mean
41968|NCT01433263|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||hr||Inter-Quartile Range|Median
41969|NCT01433263|Secondary|Maximum Observed Serum Concentration (Cmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.||ng/ml||Standard Deviation|Mean
41970|NCT01433263|Secondary|Percentage Change in Body Weight From Baseline at Week 7 and Week 9|Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9|Baseline, Week 7 and Week 9|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.||Percent Change of Weight (kg)||Standard Deviation|Mean
41971|NCT01433263|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.|Baseline, week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8||Percentage Change of TMV||Standard Deviation|Mean
41972|NCT01433250|Secondary|Measure of Disability: Expanded Disability Status Scale (EDSS).|The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.|Baseline to week 97|Not all patients may have been available at all time points for EDSS evaluation||participants|||Number
41973|NCT01433250|Secondary|Change in Brain Volume at End of Study.|Change in volume from start to end of study|week 97|||ml||Standard Deviation|Mean
41974|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions|weeks 13,25,37,53,73 and 97|||lesions||Full Range|Mean
41975|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans|weeks 13,25,37,53,73 and 97|||lesions||Full Range|Mean
41976|NCT01433250|Secondary|Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)|Description: number of relapses based on neurological assessments and EDSS|week 97|||Participants|||Number
41977|NCT01433250|Primary|Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments|Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome|97 weeks|||participants|||Number
41978|NCT01433159|Primary|Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score|"Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores.~Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound >24 cm x cm, containing necrotic tissue, with heavy exudate)"|baseline, 14 Days|Per Protocol Population||scores on a scale||Standard Deviation|Least Squares Mean
41979|NCT01433107|Secondary|Number of Subjects With Adverse Event|Number of Subjects with adverse event|6 weeks|Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.||participants|||Number
41980|NCT01433107|Secondary|Total Clinical Signs and Symptoms (S/S) Scores|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:~0 = absent~= mild~= moderate~= severe In order to calculate the total symptom score, the scores for each individual symptom are added up.~Possible range : 0 to 18"|week 6|||units on a scale||95% Confidence Interval|Mean
41994|NCT01432626|Primary|Number of Participants Who Had an Abnormal Regional Uptake of I-123 mIBG at Baseline (Acute Phase) and the Number of Participants Who Had an Abnormal I-123 mIBG Uptake on Follow up (Recovery Phase)|Number of participants who had an abnormal regional uptake of I-123 mIBG at baseline (acute phase) and the number of participants who had an abnormal I-123 mIBG uptake on follow up (recovery phase)|During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks)|||participants|||Number
42677|NCT01423617|Secondary|Changes in Waist Circumference (cm)||12 weeks|||cm||Standard Deviation|Mean
42678|NCT01423617|Secondary|Number of Subjects Who Lost at Least 3% of Baseline Body Weight||12 weeks|||participants|||Number
41981|NCT01433107|Primary|Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:~0 = absent~= mild~= moderate~= severe In order to calculate the total symptoms score the rating for all symptoms are added up.~Possible range 0 to 18"|week 6|Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).||participants|||Number
41982|NCT01433081|Secondary|Opioid Consumption|Opioid consumption after discharge|24 hours|||miligram morphine equivalents||Inter-Quartile Range|Median
41983|NCT01433081|Primary|Quality of Recovery Scores Post Operative|Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).|24 hours post operative|Two drop outs for either arm were removed from analysis.||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Mean
41984|NCT01433042|Primary|Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians|precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians|up to 6 months from end of recruitment|"Five (2%) cases were excluded from the efficacy analysis due to the following :~1 patient withdrawn prior to any procedure.~1 patient did not meet the inclusion criteria~3 cases, the capsule remained in the stomach during the entire procedure.~Therefore, 220 cases are included in the efficacy analysis."||percentage of cases|||Number
41985|NCT01433016|Primary|PDR Peak|PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.|At study day one after one hour|||percentage of dose recovery||Standard Deviation|Mean
41986|NCT01432938|Secondary|Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax) of Warfarin|Observed INRmax was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least 1 dose of warfarin with evaluable warfarin INR data.||ratio||Geometric Coefficient of Variation|Geometric Mean
41987|NCT01432938|Secondary|Pharmacodynamics: Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin|AUCINR was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin INR data.||ratio||Geometric Coefficient of Variation|Geometric Mean
41988|NCT01432938|Primary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.||hours||Full Range|Median
41989|NCT01432938|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
41990|NCT01432938|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin|Area under the concentration versus time curve (AUC) from zero to infinity was determined from plasma concentrations of the S- and R- enantiomers of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.||nanograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
41991|NCT01432886|Primary|Number of Participants With Adverse Events|The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years|The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation.||Participants|||Number
41992|NCT01432886|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.|Up to 3 weeks|The DLT analysis set included those participants who received at least one dose of study drug and had a DLT assessment in cycle 1 (3 weeks) without deviations from the eribulin mesylate/trastuzumab dosing regimens and other major protocol prescripts. Participants with a DLT, regardless of this criterion, were also included in the DLT analysis set.||Participants|||Number
41993|NCT01432756|Primary|Number of Topics Discussed Between Parent and Child|"Measured using the Parent-Child Communication Scale (communication on sexual and HIV topics that the intervention covers) for both parent and child participants in pre- and post-assessments. This is a measurement of the number of sex and HIV topics discussed. 16 topics were assessed, including how women get pregnant, how to use condoms to prevent pregnancy and HIV, and how to recognize sexual pressure.~For each topic, participants answered yes or no if they discussed it, and then rate between 1-16 to indicate their communication (higher scores mean better communication). The total scores is reported as the sum of the 16 items, and can range from 0-16."|6 months|Each dyad consisted of one parent and their adolescent child. Sixty-six parents and 66 adolescents participated.||number of sex and HIV topics discussed||Standard Deviation|Mean
41995|NCT01432574|Secondary|Change in Antibody Titers|Change in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) were calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution.|Points: Day 1 and Month 7|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.||mMU/mL (geometric mean titer)||95% Confidence Interval|Geometric Mean
41996|NCT01432574|Primary|Percentage of Participants Seropositive at Month 7|Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7.|7 Months|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.||percentage of participants|||Number
41997|NCT01432561|Primary|Time to Peak Plasma Cysteamine Concentration (Tmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose|||minutes||Standard Deviation|Mean
41998|NCT01432561|Primary|Peak Plasma Cysteamine Concentration (Cmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose|||uM||Standard Deviation|Mean
41999|NCT01432561|Primary|Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose|||min*uM||Standard Deviation|Mean
42000|NCT01432535|Primary|Apparent Volume of Distribution (Vd/F)|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||Liters||95% Confidence Interval|Geometric Mean
42001|NCT01432535|Primary|Apparent Total Body Clearance (CL/F)|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||mL/min||95% Confidence Interval|Number
42002|NCT01432535|Primary|Apparent Terminal Half-life (T1/2)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||Hours||Geometric Coefficient of Variation|Geometric Mean
42003|NCT01432535|Primary|Time to Maximum Observed Serum Concentration (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||hours||95% Confidence Interval|Median
42004|NCT01432535|Primary|Maximum Observed Serum Concentration (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||pg/mL||95% Confidence Interval|Geometric Mean
42005|NCT01432535|Primary|AUC From Time 0 to the Last Measurable Sample (AUC0-last)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||pg*hr/mL||95% Confidence Interval|Least Squares Mean
42006|NCT01432535|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.||pg*hr/mL||95% Confidence Interval|Least Squares Mean
42007|NCT01432457|Secondary|Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score|"The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.~Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function."|Baseline to Week 8 (final on-therapy)|Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline.||Units on a scale||Standard Error|Mean
42008|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.|Baseline to week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used.||percentage of the number of participants|||Number
42009|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used.||percentage of the number of participants|||Number
42010|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.||Units on scale||Standard Error|Mean
42011|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate.||Units on scale||Standard Error|Mean
42012|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data.||number of participants|||Number
42013|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.||Units on a scale||Standard Error|Mean
42014|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.||Units on a scale||Standard Error|Mean
42015|NCT01432444|Secondary|Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.|The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Week 4, 12 and 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
42057|NCT01432236|Other Pre-specified|Mean Patient Static Global Assessment (PSGA) Score at Baseline.|PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point NRS ranging from 0 (very poor) to 10 (very good).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
42679|NCT01423617|Primary|Change in Mean Body Fat (kg)|Change in mean body fat at week 12 compared to baseline|12 weeks|||kg||Standard Deviation|Mean
42016|NCT01432444|Secondary|Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).|The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
42017|NCT01432444|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
42018|NCT01432444|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
42019|NCT01432444|Secondary|Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210.|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||Units on a scale||Standard Deviation|Mean
42020|NCT01432444|Primary|Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).|Retrospective period Months 4-6; Prospective period Months 4-6|The core dataset for all efficacy analyses is the Intent-to-Treat (ITT) dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.||participants|||Number
42021|NCT01432405|Secondary|Plasma Adipocytokines|the effect of the intervention on plasma adiponectin levels.|one year|||microgram per ml||Standard Error|Mean
42022|NCT01432405|Primary|Hepatic Fat|The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.|one year|||percent of liver fat||Standard Error|Mean
42023|NCT01432379|Secondary|Incidence Rate of Intractable Migraine|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A||events per 1,000 person-months||95% Confidence Interval|Number
42024|NCT01432379|Primary|Incidence Rate of Dysphagia|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A||events per 1,000 person-months||95% Confidence Interval|Number
42025|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline|Correlation between BMQ concerns score and participant’s characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants’ beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant’s characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.||correlation coefficient||95% Confidence Interval|Number
42680|NCT01423617|Primary|Change in Mean Body Weight (kg)|Change in mean body weight at week 12 compared to baseline.|12 weeks|||kg||Standard Deviation|Mean
42026|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline|Correlation between BMQ necessity score and participant’s characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants’ beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant’s characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.||correlation coefficient||95% Confidence Interval|Number
42027|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity–concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost–benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.||correlation coefficient||95% Confidence Interval|Number
42028|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity–concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost–benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.||correlation coefficient||95% Confidence Interval|Number
42029|NCT01432366|Secondary|Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline, Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||percentage of participants|||Number
42030|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||percentage of participants|||Number
42047|NCT01432262|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 1 Month (28 to 42 days) after vaccination|Safety Population included all participants who received the vaccine.||percentage of participants||95% Confidence Interval|Number
43223|NCT01413360|Secondary|The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks|Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level|Baseline and 12 weeks|||pg/mL||Full Range|Median
42031|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items.||percentage of participants|||Number
42032|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety|Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at each specified time point.||correlation coefficient||95% Confidence Interval|Number
42033|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.||correlation coefficient||95% Confidence Interval|Number
42034|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety|Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.||correlation coefficient||95% Confidence Interval|Number
42035|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.||correlation coefficient||95% Confidence Interval|Number
42036|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12|Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
42056|NCT01432236|Other Pre-specified|Mean PSGA Score at End of Period.|PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point numeric rating scale (NRS) ranging from 0 (very poor) to 10 (very good).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
42695|NCT01423084|Secondary|Number of Subjects Reporting SAEs and AE Leading to Withdrawal|Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject’s withdrawal from the study after any vaccination.|Throughout the study period.|Safety Set||Number of subjects|||Number
42037|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12|Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
42038|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12|Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
42039|NCT01432366|Primary|Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12|Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 [very well] to 100 millimeter (mm) [extremely bad]). DAS28 less than or equal to (<=) 3.2=low DA; greater than (>) 3.2 to <=5.1=moderate DA; >5.1=high DA; <2.6=remission.|Month 12|Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||correlation coefficient||95% Confidence Interval|Number
42040|NCT01432327|Secondary|Step Count|Daily number of steps|One Year||||||
42041|NCT01432327|Secondary|Stages of Motivational Readiness for Physical Activity|According to The Stages of Motivational Readiness for Change Model (SOC), individuals move through a series of stages as they adopt and maintain a new habit(Prochaska & DiClemente, 1983). Specifically, the stages include Precontemplation, Contemplation, Preparation, Action, and Maintenance.The relevant variables were assessed in a self-administered questionnaire.|One Year||||||
42042|NCT01432327|Secondary|Percent of Participants Losing Fat Percentage|The amount of body fat is measured by bioelectrical impedance analysis (BIA).|One Year||||||
42043|NCT01432327|Secondary|Daily Energy Expenditure in Physical Activity|Minutes of physical activity. Activities can be classified as moderate-intensity, vigorous-intensity or very vigorous-intensity activities based upon the amount of energy used by the body while doing the activity.|One year||||||
42044|NCT01432327|Primary|Physical Activity Level|To account for differences in body size and composition, the 24-hour energy requirement (kcal/day) is expressed as a multiple of the basal metabolic rate per 24 hours by using the PAL value (PAL = total energy expenditure/basal metabolic rate). A desirable PAL includes the regular practice of physical activity at work or in spare time with an intensity and duration that will reduce the risk of becoming overweight and developing a variety of non-communicable chronic diseases usually associated as co-morbidities with obesity. This corresponds to PAL values of 1.75 and higher.|One year|Intention to treat analysis was used and analyses data from all participants, including those who did not complete the study||Metabolic Equivalent||Standard Deviation|Mean
42045|NCT01432262|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination|Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result, received no prohibited vaccines, and had no other major protocol violations. Here “N” signifies participants with valid and determinate assay results at both pre-vaccination and post-vaccination.||fold rise||95% Confidence Interval|Geometric Mean
42046|NCT01432262|Secondary|Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
42048|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in >1 category.||percentage of participants||95% Confidence Interval|Number
42049|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in >1 category.||percentage of participants||95% Confidence Interval|Number
42050|NCT01432262|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.|One month (28 to 42 days) after vaccination|Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
42051|NCT01432236|Other Pre-specified|Health Utilization Assessment (Time for Help no Payment) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. 'Time for help no payment' refers to time other people spent without receiving payment to help with activities the patient cannot perform due to fibromyalgia.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Hours||Standard Deviation|Mean
42052|NCT01432236|Other Pre-specified|Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Visits||Standard Deviation|Mean
42053|NCT01432236|Other Pre-specified|Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline.|WPAI-SHP assessed work productivity and impairment. It was a participant-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past 7 days. Subscale scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Each subscale score was expressed as an impairment percentage (0-100) where higher numbers indicated greater impairment and less productivity.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
42054|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline.|C-SSRS assessed whether participant experienced following:completed suicide (1), suicide attempt (2) (response of Yes on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (Yes on “preparatory acts or behavior”), suicidal ideation (4) (Yes on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on “Has subject engaged in non-suicidal self-injurious behavior”). Below table indicated one participant (10141023) treated with Pregabalin reported preparatory act. However upon study unblinding it was clarified that preparatory act occurred while the participant was taking placebo. Since preparatory act was reported at first visit of Period 2, by convention statistical summaries classified this under Pregabalin treatment.|From Visit 3 to Visit 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Participants|||Number
42055|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline.|C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Participants|||Number
42058|NCT01432236|Secondary|EQ-5D Score at End of Period.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
42059|NCT01432236|Secondary|Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
42060|NCT01432236|Secondary|HADS at End of Period.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
42061|NCT01432236|Secondary|Hospital Anxiety and Depression Scale (HADS) at Baseline.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
42062|NCT01432236|Secondary|Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Number of times awakened||Standard Error|Least Squares Mean
42063|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Minutes||Standard Error|Least Squares Mean
42064|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Minutes||Standard Error|Least Squares Mean
42065|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Minutes||Standard Error|Least Squares Mean
42066|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.|Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
42067|NCT01432236|Secondary|Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.|Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period.|Visits 2, 6, and 12|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Percentage of participants|||Number
42068|NCT01432236|Other Pre-specified|PGIC at the End of Period 2.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Because of the crossover design and PGIC recall period (since starting study medication), the Period 1 PGIC data were felt to provide the clearest comparison across treatments, whereas Period 2 PGIC data were felt to have a more complex interpretation. Thus PGIC at End of Period 2 was separately analyzed from PGIC at End of Period 1.|End of Period 2 at Week 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Percentage of Participants|||Number
42069|NCT01432236|Secondary|Patient Global Impression of Change (PGIC) at the End of Period 1.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|End of Period 1 at Week 6|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Percentage of participants|||Number
42070|NCT01432236|Secondary|FIQ Score at End of Period.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study.||Units on a scale||Standard Error|Least Squares Mean
42071|NCT01432236|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Deviation|Mean
42072|NCT01432236|Primary|Mean NRS Pain Score at End of Period.|The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
42073|NCT01432015|Primary|Overall Complete Response Rate|no emetic episodes or rescue therapy following the initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).||percentage of participants|||Number
42074|NCT01432015|Secondary|Impact on Daily Living Activities|Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).||percentage of participants|||Number
42075|NCT01431989|Primary|First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)|This parameter is estimated via linear regression of time versus log concentration. It allows for the obtainment of estimates of T1/2 (T1/2=ln(2)/Kel) considering the schedule and the detection limits defined.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||1/hr||Standard Deviation|Mean
42076|NCT01431989|Primary|Terminal Half-life (T1/2_Kel)|T1/2_Kel is calculated by using the formula T1/2_Kel = Ln(2)/Kel.T1/2 is of particular use in measuring bioavailability, by measuring the elimination of the product.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||hr||Standard Deviation|Mean
42113|NCT01431716|Primary|Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.||mmHg||Standard Deviation|Mean
42696|NCT01423084|Secondary|Number of Subjects Reporting Unsolicited AEs|Number of subjects reporting any Unsolicited AEs after any vaccination.|From day 1 to day 7 after any vaccination.|Safety Set||Number of subjects|||Number
42077|NCT01431989|Primary|Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC_%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter is to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t) Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||percentage||Standard Deviation|Mean
42078|NCT01431989|Primary|Time of Maximum Observed Concentration (Tmax)|The time of maximum observed concentration (Tmax) is obtained directly from the plasma concentration curve of the drug by non-compartimental method. Tmax is of particular use in measuring bioavailability, by measuring the time at which the maximum concentration is achieved.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||hr||Standard Deviation|Mean
42079|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)|Measurement of AUC0-inf is obtained directly from the plasma concentration curve of drug against time (non-compartmental method). AUC0-inf is calculated from time 0 (prior to administration of medication) extrapolated to infinity, by using the formula AUC0-inf = AUC0-t + Clast/Kel, where Clast is the last measurable concentration, and Kel is the first-order rate constant associated with the terminal portion of the curve. AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1[Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||ng*hr/mL||Standard Deviation|Mean
42080|NCT01431989|Primary|Maximum Observed Concentration of Drug Through Time (Cmax)|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Measurement is obtained directly from the plasma concentration curve of the drug (non-compartmental method).|Collection points (hrs): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||ng/mL||Standard Deviation|Mean
42081|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)|The area under the plot of plasma concentration of drug against time (non-compartmental method), after drug administration, is defined as the area under the curve (AUC). AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; mL, milliliter.|Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population||ng per hour per ml (ng*hr/mL)||Standard Deviation|Mean
42082|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Extension Phase (ExP) Overall|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided.|Extension Week 12 (Extension Visit 1 [Ext-V1], every 12 week after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Days||Standard Deviation|Mean
42083|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Main Study Phase (Fixed Escalation Phase [FEP], Escalation Phase [EP], Maintenance Phase [MP]), and FEP+EP+MP)|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title)|Up to Study Week 50|FAS||Days||Standard Deviation|Mean
42084|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Assessment Point in the Extension Phase (ExP)|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the ExP, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 24 (Extension Visit 2 [Ext-V2], every 24 weeks after the Ext-V2 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Participants|||Number
42085|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Each Assessment Point in the Extension Phase (ExP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 12 (Extension Visit 1 [Ext-V1]), every 24 weeks after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Participants|||Number
42114|NCT01431716|Primary|Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||mmHg||Standard Deviation|Mean
42697|NCT01423084|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.|From day 1 to day 7 after any vaccination|Safety Set||Number of subjects|||Number
42086|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs During Week 4 and Week 8 of the Maintenance Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Maintenace Phase, HV-clinical signs were assessed at Visit 1 (Week 4) and Visit 2 (Week 4).|Week 4 and Week 8 of the Maintenance Phase (up to Study Weeks 42 and 46, respectively)|FAS. Only those participants who were dosed with investigational product at the indicated time points were analyzed.||Participants|||Number
42087|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Escalation Phase, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Up to Study Week 49|FAS. Only those participants given the indicated dose of investigational product were analyzed.||Participants|||Number
42088|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them.|Up to Study Week 49|FAS||Participants|||Number
42089|NCT01431976|Primary|Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes using a pin-wheel provided to them.|Week 12 of the Maintenance Phase (up to Study Week 50)|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and contributed data to at least one efficacy measure after the first dosing of investigational product||Participants|||Number
42090|NCT01431963|Secondary|Time to the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)|The time to the first seizure in the Maintenance Phase is measured at the time the first seizure occurred in the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|FAS. Only those participants available at the specified time point were analyzed.||Days||Standard Error|Mean
42091|NCT01431963|Secondary|Time to Withdrawal/Dropout From the Study (Across Seizure Types and by Seizure Type in Past 6 Months in the Escalation and Maintenance Phases)|Time to withdrawal is defined as the time from the start of treatment until withdrawal from the study. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures which affect only a small region of the brain, often the temporal lobes or hippocampi. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|up to Week 30|FAS. Only those participants available at the specified time point were analyzed.||Days||Standard Error|Mean
42092|NCT01431963|Primary|Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study)|Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|Full Analysis Set (FAS): all participants in the Safety Population (SP) who provided at least one set of efficacy data after the first dosing of investigational product. The SP is comprised of all participants who had taken at least one dose of investigational product. Only those participants available at the specified time point were analyzed.||participants|||Number
42115|NCT01431716|Primary|Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||mmHg||Standard Deviation|Mean
42093|NCT01431950|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
42094|NCT01431950|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||L/min||Standard Error|Least Squares Mean
42095|NCT01431950|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
42096|NCT01431950|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
42097|NCT01431950|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
42098|NCT01431846|Primary|See Primary Outcome Description Below|Follow up appointment within 2 weeks of discharge back to their primary care providers at a primary care facility from a tertiary referral center.|Within 2 weeks of discharge|||participants|||Number
42099|NCT01431755|Secondary|Number of Subjects Reporting Adverse Event|"Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.~All subjects were injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek."|Up to 12 months|Safety population, 54 subjects.||participants|||Number
42100|NCT01431755|Secondary|Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.|A subject diary was completed for 14 days following the initial treatment and the optional re-treatment at the 3-month visit. Each subject was asked to record the presence of bruising, redness, swelling, pain, tenderness and itching.|14 days|Safety Population. 54/54 subjects.||participants|||Number
42116|NCT01431716|Primary|Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||dyn/sec/cm^5||Standard Deviation|Mean
42101|NCT01431755|Secondary|Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks|The severity of midface volume loss or midface contour deficiency was assessed by the investigators using a 4-graded scale, Medicis Midface Volume Scale -MMVS (1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing). Each score were exemplified by photographic images on the scale. A one grade decrease in score from screening was defined as a treatment success/improvement.The efficacy in terms of Medicis Midface Volume Scale (MMVS) was assessed by the Investigator per treatment group. The two cheeks were evaluated separately. MMVS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects||percentage of participants||95% Confidence Interval|Number
42102|NCT01431755|Secondary|Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)|Esthetic improvement was evaluated by using Global Esthetic Improvement Scale. GEIS was evaluated by comparing current photos with pre-treatment photos and using a 5-graded scale (worse/no change/somewhat improved/much improved/very much improved). A clinically significant global esthetic improvement was defined as a score of somewhat improved, much improved or very much improved. GEIS was assessed by the Investigator and the subject. Each cheek/study product was evaluated separately. GEIS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects||percentage of participants||95% Confidence Interval|Number
42103|NCT01431755|Secondary|Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.|"Pain was assessed during the first 2 hours after the initial injection of the study products using a 100 mm VAS. The endpoints of the scale were no pain (0 mm) and worst possible pain (100 mm). Pain was assessed at the time points 15, 30, 60, 90 and 120 minutes after injection."|15 and 120 minutes|Intention to treat. 54/54 subjects||units on a scale||Standard Deviation|Mean
42104|NCT01431755|Primary|Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.|When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).|When injection of both cheeks were completed|Intention to treat. 54/54 subjects||percentage of participants||95% Confidence Interval|Number
42105|NCT01431716|Other Pre-specified|Number of Participants With Adverse Events Leading to Discontinuation of Study Drug From Baseline to EOT.|Adverse events that led to discontinuation of study drug from the start of study treatment until the end of study treatment were recorded.|Approximately 3 months|All-treated set.||participants|||Number
42106|NCT01431716|Other Pre-specified|Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question global satisfaction scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
42107|NCT01431716|Other Pre-specified|Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question convenience scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
42108|NCT01431716|Other Pre-specified|Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question effectiveness scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
42109|NCT01431716|Other Pre-specified|Change in N-terminal Pro-B-type Natriuretic Peptide (NT proBNP) From Baseline to EOT.|Blood sampling for NT proBNP was performed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||ng/L||Standard Deviation|Mean
42110|NCT01431716|Other Pre-specified|Number of Participants With Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) From Baseline to EOT.|NYHA FC was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. Disease severity was assessed by NYHA classification of pulmonary arterial hypertension criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||participants|||Number
42111|NCT01431716|Other Pre-specified|Change in Borg Dyspnea Score From Baseline to EOT.|"The Borg dyspnea score was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labelled extremely severe, or the worst possible dyspnea imaginable."|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||units on a scale||Standard Deviation|Mean
42112|NCT01431716|Primary|Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values||L/min/m^2||Standard Deviation|Mean
42117|NCT01431716|Other Pre-specified|Change in 6-minute Walk Distance (6MWD) From Baseline to EOT.|The 6MWD was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The 6-minute walk test is a non-encouraged test that measures the distance walked for the duration of 6 min.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.||m||Standard Deviation|Mean
42118|NCT01431716|Primary|Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.||dyn/sec/cm^5||Standard Deviation|Mean
42119|NCT01431521|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The AST Population consists of all participants who received at least one dose of the study drug.||Participants|||Number
42120|NCT01431521|Primary|Number of Participants Experiencing One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 10 weeks|All Subjects as Treated (AST) Population consists of all participants who received at least one dose of the study drug.||Participants|||Number
42121|NCT01431521|Secondary|Percent Change From Baseline Aspartate Transaminase (AST)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, including AST, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have AST data for Day 28.||Percent change||95% Confidence Interval|Least Squares Mean
42122|NCT01431521|Secondary|Percent Change From Baseline in Alanine Transaminase (ALT)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, specifically ALT, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have ALT data for Day 28.||Percent change||95% Confidence Interval|Least Squares Mean
42123|NCT01431521|Primary|Percent Change From Baseline in Hepatic Fat|Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant.|Baseline and Week 4|Per-Protocol (PP) Population consists of those participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percent change||95% Confidence Interval|Least Squares Mean
42124|NCT01431508|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.|At Baseline and Week 12|Intention-to-Treat||mm Hg||Standard Deviation|Mean
42125|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
42126|NCT01431339|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
42127|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of other therapy|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
42128|NCT01431339|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|After 48-72 hours of therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
42129|NCT01431300|Secondary|Quantitative Analysis Noise Ratios|"Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows:~Signal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background.~Contrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background."|14 weeks|||ratio||Standard Deviation|Mean
42130|NCT01431300|Primary|Imaging Quality Score|"Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows:~poor / nondiagnostic~adequate~good~excellent"|14 weeks|||Units on a visualization score scale||Full Range|Mean
42406|NCT01427803|Secondary|Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection|28 days|Participants in Patterns of Use cohort who took the product||Percentage of dosing occasions|Participants||Number
42131|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 365 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42132|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 85 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42133|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 43 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42134|NCT01431287|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42135|NCT01431287|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42136|NCT01431287|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12-hr PFT set||Litres||Standard Error|Least Squares Mean
42298|NCT01430091|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.||nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
42137|NCT01431287|Secondary|FVC AUC(0-12h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12-hr PFT set||Litres||Standard Error|Least Squares Mean
42138|NCT01431287|Secondary|FEV1 AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12−hr PFT set||Litres||Standard Error|Least Squares Mean
42139|NCT01431287|Secondary|FEV1 AUC(0-12h) Response in Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.||Litres||Standard Error|Least Squares Mean
42140|NCT01431287|Secondary|Trough FVC Response on Day 365|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42141|NCT01431287|Secondary|Trough FVC Response on Day 170|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23h and at 23h 50 min after inhalation of study medication on day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42142|NCT01431287|Secondary|Trough FVC Response on Day 85|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42317|NCT01429077|Secondary|Participation in Everyday Activities|Measures on CETI, QCL,BOSS, CCRSA.|Change from Baseline in participation in everyday activities at 6 weeks||||||
42143|NCT01431287|Secondary|Trough FVC Response on Day 43|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42144|NCT01431287|Secondary|Trough FVC Response on Day 15|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42145|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
42146|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
42147|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
42218|NCT01430754|Primary|Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks|||participants|||Number
42148|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Median
42149|NCT01431287|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42150|NCT01431287|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42151|NCT01431287|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42152|NCT01431287|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42153|NCT01431287|Secondary|Trough FEV1 Response on Day 15|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42154|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42155|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (on day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42156|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42157|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274) is the key secondary endpoint.~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42158|NCT01431287|Primary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42159|NCT01431287|Primary|Trough FEV1 Response on Day 170|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42219|NCT01430624|Secondary|PTSD Symptom Scale Self-Report (PSS-SR)|Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.|2 weeks prior to 6 week, 3 month, 6 month followup|Only includes those with complete scale score information||units on a scale||Standard Deviation|Mean
42220|NCT01430624|Secondary|Non-medical Use of Prescription Drugs Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|2 participants had missing data at 6 month follow-up||days of use||Standard Deviation|Mean
42221|NCT01430624|Primary|Marijuana Use Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|||days of use||Standard Deviation|Mean
42160|NCT01431287|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.||Litres||Standard Error|Least Squares Mean
42161|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 365 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42162|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 85 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS||points on a scale||Standard Error|Least Squares Mean
42163|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 43 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42164|NCT01431274|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42165|NCT01431274|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42318|NCT01429077|Secondary|Functional Communication Skills|Scores derived from language sample analyses|Change from Baseline in functional communication skills at 6 weeks||||||
42166|NCT01431274|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set||Litres||Standard Error|Least Squares Mean
42167|NCT01431274|Secondary|FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12−hr PFT set||Litres||Standard Error|Least Squares Mean
42168|NCT01431274|Secondary|FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set||Litres||Standard Error|Least Squares Mean
42169|NCT01431274|Secondary|FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.||Litres||Standard Error|Least Squares Mean
42170|NCT01431274|Secondary|Trough FVC Response on Day 365.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42171|NCT01431274|Secondary|Trough FVC Response on Day 170.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42222|NCT01430624|Primary|Amount of Alcohol Use|estimated number of drinks during the 14 days prior to each follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|1 participant with missing data at 6 week follow-up||Drinks||Standard Deviation|Mean
42172|NCT01431274|Secondary|Trough FVC Response on Day 85.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42173|NCT01431274|Secondary|Trough FVC Response on Day 43.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42174|NCT01431274|Secondary|Trough FVC Response on Day 15.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42175|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42176|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42223|NCT01430624|Secondary|Any Other Illicit Drug Use|Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up|14 days prior to 6 week, 3 month, 6 month follow-up|||participants|||Number
42224|NCT01430624|Primary|Cigarettes (Estimated Number)|quantity in 14 days prior to 6 week, 3 month and 6 month follow-up|14 days preceding 6 week, 3 month and 6 month follow-up|1 participant missing 6 week cigarette smoking information||cigarettes||Standard Error|Mean
42225|NCT01430624|Primary|Alcohol Use Disorders Identification Test (AUDIT)|Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months|6 months|Includes only participants with full scale score information at 6 months||units on a scale||Standard Deviation|Mean
42177|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42178|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42179|NCT01431274|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42180|NCT01431274|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42181|NCT01431274|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42182|NCT01431274|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43.|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42183|NCT01431274|Secondary|Trough FEV1 Response on Day 15.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42184|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42185|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42186|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42187|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) is the key secondary endpoint.~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42188|NCT01431274|Primary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||points on a scale||Standard Error|Least Squares Mean
42226|NCT01430624|Primary|Drug Abuse Screening Test (DAST-10)|total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months|6 months|Only includes participants with complete scale data at 6 months||units on a scale||Standard Deviation|Mean
42254|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-4 (Omalizumab vs. ICS)|The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients >= 12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of <= 19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent-to-treat with available ACT Scores||ACT Score||Standard Error|Mean
42189|NCT01431274|Primary|Trough FEV1 Response on Day 170.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.||Litres||Standard Error|Least Squares Mean
42190|NCT01431274|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169.|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.||Litres||Standard Error|Least Squares Mean
42191|NCT01431170|Post-Hoc|Number of Subjects Treated Successfully at Close-Out Visit (Week 16)|Treatment Success is defined as a grade of 0 or improvement by 2 or more compared to the prior visit.|Baseline to Week 16 (Close-Out Visit)|||Number of Treatment Success|||Number
42192|NCT01431170|Secondary|Medication Safety Outcomes|During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator.|Baseline to Week 16 (Closeout Visit )|No safety issues were reported||Number of Adverse Events|||Number
42193|NCT01431170|Secondary|Treatment Failure|"Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists.~Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care."|Baseline to the time of failure or Week 16 (Closeout Visit)|||Number of Treatment Failures|||Number
42194|NCT01431170|Secondary|Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO|"Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as Treatment Success or Treatment Failure according to study protocol."|Baseline to Week 16 (Closeout Visit)|||participants|||Number
42195|NCT01431170|Secondary|Number of Recurrences by Randomization Group|"Recurrence is defined as when the NLDO with infection in the subject’s study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit.~Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group."|Baseline to Week 16 (Closeout Visit )|The overall study recurrence rate was 10% study-wide (2 of 20 subjects), with one Besivance subject (11%), and one Polytrim subject (9%) experiencing recurrence.||Recurrence Subjects|||Number
42196|NCT01431170|Primary|Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier.|"The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4:~0: No tearing and discharge.~1: Tearing, moderate mucous discharge around nasolacrimal punctum~2: Moderate redness of the medial eyelid with mucous discharge~3: Redness and swelling of the eyelid with mucopurulent discharge~4: Redness and swelling of eyelid with purulent discharge~Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following:~Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit.~Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit.~Treatment Failure: grade is worse than or same as the baseline visit."|Baseline to Week 8|||participants|||Number
42197|NCT01431144|Primary|Soft Tissue Thickness Over the Implant|Soft tissue thickness at the facial osseous crest.|1 year|||mm||Standard Deviation|Mean
42198|NCT01431131|Secondary|Histologic Healing of the Osseous Graft|Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages|4 months|||percentage vital bone||Standard Deviation|Mean
42199|NCT01431131|Primary|Horizontal Ridge Dimension|WIll be measured with a digital caliper at baseline and 4 months.|Baseline and 4 months|||mm||Standard Deviation|Mean
42200|NCT01431079|Secondary|Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine|"Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.~The difference between post and pre-test was taken to determine a change score. This score was then used for regressions."|Post interventions and up to 3 months follow-up|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
42201|NCT01431079|Secondary|Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine|"Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability.~Difference between post and pre-test were used to obtain a change score. This score was used for regressions."|Post interventions and up to three months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
42202|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine|"Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.~A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression."|post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
42203|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine|"Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
42204|NCT01431079|Secondary|Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
42205|NCT01431079|Secondary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
42253|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4)|Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/=20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day. Odds ratio comparing Inhaled corticosteroid boost therapy (ICS) and Omalizumab arms at Treatment Steps 2-4.|90 Day outcome period|Intent-to-treat||Percent of adjusted prevalence|||Number
42206|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units)|"Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted.~Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale."|Post intervention and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||units on a scale||Standard Deviation|Mean
42207|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine|Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted.|Post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.||participants|||Number
42208|NCT01431014|Primary|Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery|Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose.|1 year|||ml||Standard Deviation|Mean
42209|NCT01430819|Other Pre-specified|Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.~Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios."|Day 21 post-vaccination|Geometric mean of titer ratios of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
42210|NCT01430819|Other Pre-specified|Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40; or a pre-vaccination titer ≥ 1:10 and a four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population||Participants|||Number
42211|NCT01430819|Other Pre-specified|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|GMTs of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
42212|NCT01430819|Primary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm."|Day 0 to up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population (Safety Analysis Set).||Participants|||Number
42213|NCT01430754|Secondary|Change From Run-In in Circadian Time to Relapse During the Randomized Phase|Time to relapse is defined as a 45 minute or greater decrement in the weekly average of subjective nighttime total sleep time (nTST) compared to the Run-in Phase.|Approximately 8 weeks|||days||95% Confidence Interval|Median
42214|NCT01430754|Secondary|Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase|Midpoint of Sleep Timing (MoST) is the measurement of the average timing of sleep relative to bedtime. The average MoST value will trend to 0 as an individual’s sleep becomes more fragmented. Improvement is defined as an increase in the average.|Approximately 12 weeks|||minutes||Standard Error|Mean
42215|NCT01430754|Secondary|Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase|UQ-dTSD measures the average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) from run-in and randomized phase. Lower number indicates improvement.|Approximately 12 weeks|||minutes||Standard Error|Mean
42216|NCT01430754|Secondary|Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase|LQ-nTST measures the average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) from run-in and randomized phase. The higher number indicates improvement.|Approximately 12 weeks|||minutes||Standard Error|Mean
42217|NCT01430754|Secondary|Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks|||participants|||Number
43224|NCT01413360|Primary|The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks|Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level|Baseline and 12 weeks|||IU/L||Full Range|Median
42227|NCT01430611|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature >39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set (SafAS). A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (where classification was per vaccine randomized to) and also Group 1 SafAS (where classification was according to vaccine actually received).||Participants|||Number
42228|NCT01430611|Secondary|Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
42229|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
42230|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
42231|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
42232|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
42233|NCT01430611|Primary|Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 30 post-vaccination|Seroconversion was assessed in the Per-protocol Analysis Set.||Participants|||Number
42234|NCT01430585|Secondary|Number of Participants With Genetic Alterations: Phase 2|Following genetic alterations were planned to be analyzed: mutations in Phosphoinositide 3-kinase, catalytic, alpha (PIK3CA), amplification of PIK3CA, Phosphate and tensin homolog (PTEN) deficiency, and changes in other genes or proteins in, or impacting V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS), Insulin-like Growth Factor 1 Receptor (IGF-1R), phosphatidylinositol 3-kinase (PI3K)/ mammalian target of rapamycin (mTOR) pathway.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42235|NCT01430585|Secondary|Change From Baseline in Pharmacodynamic, Cell Proliferation and Survival Biomarkers in Biopsied Tumor Tissue at Week 2 and 6: Phase 2|Change from baseline in following pharmacodynamic parameters were planned to be calculated: expression and/or phosphorylation of Phosphoinositide-3-kinase (PI3K) pathway proteins in biopsied tumor tissue and markers of cell cycle and survival.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42236|NCT01430585|Secondary|Pharmacokinetic (PK) Parameters of PF-04691502 and Letrozole: Phase 1B and 2|Phase 1B: Following PK parameters were planned to be calculated from the plasma concentration time data using standard non-compartmental methods. For PF-04691502: area under the curve from time zero to last quantifiable concentration (AUClast), area under the curve from time zero to end of dosing interval (AUCtau), maximum observed plasma concentration (Cmax), minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), time to reach maximum observed plasma concentration (Tmax), observed accumulation ratio (Rac [obs]); for letrozole: AUClast, Cmax. Phase 2: Following PK parameters were planned to be calculated for PF-04691502 from the plasma concentration time data using standard non-compartmental methods- AUClast, Cmax and Tmax.|Phase 1B: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1 (letrozole alone), Day 2 (PF-0491502 alone), Day 12, Week 5 (PF-0491502 and letrozole in combination); Phase 2: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1, pre-dose on Week 2, 6|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42296|NCT01430091|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.||hours||Full Range|Median
42237|NCT01430585|Secondary|Number of Participants With Objective Response (OR): Phase 1B and 2|Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No appearance of new lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (>=) 30 percent (%) decrease from baseline of the sum of diameters of all target lesions, using the short diameter in the sum for target nodes and the longest diameter in the sum for all other target lesions.|Phase 1B: Baseline, Week 12, end of treatment (Week 34); Phase 2: Baseline, Week 6, 16 or ET|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42238|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Corrected QT (QTc) Interval: Phase 1B||Phase 1B: Baseline up to end of treatment (Week 34)|Data was not analyzed due to premature termination of the study.|||||
42239|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs: Phase 1B and 2|Vital signs assessments planned to include measurement of blood pressure and heart rate.|Phase 1B: Baseline up to 28 days after last dose of study treatment (Week 34); Phase 2: Baseline up to Week 16 or ET|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42240|NCT01430585|Secondary|Number of Participants With Clinically Significant Laboratory Tests Abnormalities: Phase 1B and 2|Laboratory analysis planned to include blood chemistry, hematology and urinalysis.|Phase 1B: Baseline up to end of treatment (Week 34); Phase 2: Baseline up to Week 16 or early termination (ET)|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42241|NCT01430585|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 2|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 2: Baseline up to 28 days after last administration of study treatment|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42242|NCT01430585|Primary|Change From Baseline in Ki-67 Percent Positive Tumor Cells in Biopsied Tumor Tissue at Week 6: Phase 2|Nuclear proliferation marker Ki-67 was to be assessed by immunohistochemistry technique in all specimens.|Phase 2: Baseline, Week 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.|||||
42243|NCT01430585|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 1B|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 1B: Baseline up to 28 days after last administration of study treatment|Safety analysis set included all enrolled participants who started study treatment.||participants|||Number
42244|NCT01430403|Secondary|Home Allergen Levels||4-5 months||08/2016||||
42245|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-4 (Omalizumab vs. ICS)|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent-to-treat||percent adherence||Standard Error|Mean
42246|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-5 (Omalizumab vs. Placebo)|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent–to-treat||percent adherence||Standard Error|Mean
42247|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-4 (Omalizumab vs. ICS)|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent-to-treat||Rate||Standard Error|Mean
42248|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-5 (Omalizumab vs. Placebo)|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent–to-treat||Rate||Standard Error|Mean
42249|NCT01430403|Secondary|Work Disruptions Due to Child’s Asthma, Treatment Steps 2-4 (Omalizumab vs. ICS)|The ratio of the work hours missed due to child’s asthma over the numbers of work hours in the past 14 days among caretakers working|90 Day outcome period|Intent-to-treat with available data||Rate||Standard Error|Mean
42250|NCT01430403|Secondary|Work Disruptions Due to Child’s Asthma, Treatment Steps 2-5 (Omalizumab vs. Placebo)|The ratio of the work hours missed due to child’s asthma over the numbers of work hours in the past 14 days among caretakers working.|90 Day outcome period|Intent–to-treat with available data||Rate||Standard Error|Mean
42251|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-4 (Omalizumab vs. ICS)|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined.|90 Day outcome period|Intent-to-treat with available C-ACT Scores||C-ACT Score||Standard Error|Mean
42252|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-5 (Omalizumab vs. Placebo)|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined|90 Day outcome period|Intent–to-treat with available C-ACT Scores||C-ACT Score||Standard Error|Mean
42255|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-5 (Omalizumab vs. Placebo)|Outcome measure description: The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients >= 12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of <= 19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent–to-treat with available ACT scores||ACT Score||Standard Error|Mean
42256|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-4 (Omalizumab vs. ICS)|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.|90 Day outcome period|Intent-to-treat||percent FEV1/FVC ratio||Standard Error|Mean
42257|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5 (Omalizumab vs. Placebo)|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.|90 Day outcome period|Intent–to-treat||percent FEV1/FVC ratio||Standard Error|Mean
42258|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4 (Omalizumab vs. ICS)|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent-to-treat||percent predicted FEV1||Standard Error|Mean
42259|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5 (Omalizumab vs. Placebo)|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent–to-treat||percent predicted FEV1||Standard Error|Mean
42260|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-4 (Omalizumab vs. ICS)|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent-to-treat with available CASI scores||CASI Score||Standard Error|Mean
42261|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-5 (Omalizumab vs. Placebo)|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent–to-treat||CASI Score||Standard Error|Mean
42262|NCT01430403|Secondary|Number of Exacerbations Evaluated Monthly With and Without Viral Respiratory Infections||4-5 months||08/2016||||
42263|NCT01430403|Secondary|Severity of Asthma Symptoms Associated With a Viral Infection|Defined as the highest value among the following 3 variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which the participant had to slow down or discontinue play/physical activities over a two-week period|4-5 months||08/2016||||
42264|NCT01430403|Secondary|Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples||4-5 month||08/2016||||
42265|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5])|Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day. Odds ratio comparing Placebo and Omalizumab arms across all treatment steps (Steps 2-5).|90 Day outcome period|Intent–to-treat||Percent of adjusted prevalence|||Number
42266|NCT01430325|Primary|Participant Perception of Breathing Gas|Percent of participants in each arm guessing that their breathing gas was 100% oxygen.|Within 15 minutes of chamber excursion|40 of 42 participants provided an answer to this question.||percentage of participants|||Number
42267|NCT01430325|Primary|Participant Perception of Depth|Mean depth perception for participants providing a free response.|Within 15 minutes of chamber excursion|"23 of 42 participants provided a numerical response. The remainder selected I do not know."||fsw||Standard Deviation|Mean
42268|NCT01430325|Primary|"Participants Indicating I do Not Know on Depth Questionnaire."|"Participants indicating I do not know on depth questionnaire instead of providing a free response guess."|Within 15 minutes of chamber excursion|All participants who enrolled in the study were analyzed.||participants|||Number
42269|NCT01430182|Primary|Opioid Consumption|Number of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit|First 24 hours after discharge from Post-Anesthesia Care Unit|||mg of morphine IV equivalents||Standard Deviation|Mean
43225|NCT01413204|Secondary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs||Week 24||||||
42270|NCT01430169|Primary|AUX-II Tmax After Injection 2|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19) In addition, 2 subjects have been excluded from the analysis due to ELISA interference. Of the 38 AUX-II profiles,23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.||hours||Standard Deviation|Mean
42271|NCT01430169|Primary|AUX-I Tmax After Injection 2|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|"Pharmacokinetic (PK) population (N=19). In addition, 2 subjects have been excluded from the analysis due to ELISA interference.~Of the 38 AUX-I profiles, 7 had no quantifiable plasma concentrations through 24 hours post injection."||hour||Standard Deviation|Mean
42272|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)||ng*h/mL||Standard Deviation|Mean
42273|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng*h/mL||Standard Deviation|Mean
42274|NCT01430169|Primary|AUX-II Cmax After Injection 2|Maximum AUX-II enzyme concentration from zero to 24 hours after Injection 2. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)||ng/mL||Standard Deviation|Mean
42275|NCT01430169|Primary|AUX-I Cmax After Injection 2|Maximum AUX-I enzyme concentration from zero to 24 hours after Injection 2.AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng/mL||Standard Deviation|Mean
42276|NCT01430169|Primary|AUX-II Tmax After Injection 1|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19) One subject was excluded from AUX-II PK analyses due to insufficient quantities of plasma for bioanalysis. Of the 38 AUX-II profiles, 23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.||hours||Standard Deviation|Mean
42277|NCT01430169|Primary|AUX-I Tmax After Injection 1|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). For 3 subjects Tmax was considered missing if concentration was BLQ for all time points at that injection and 2 subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||hours||Standard Deviation|Mean
42278|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19)||ng*h/mL||Standard Deviation|Mean
42279|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng*h/mL||Standard Deviation|Mean
42280|NCT01430169|Primary|AUX-II Cmax After Injection 1|Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19).||ng/mL||Standard Deviation|Mean
42297|NCT01430091|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
42281|NCT01430169|Primary|AUX-I Cmax After Injection 1|Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)||ng/mL||Standard Deviation|Mean
42282|NCT01430130|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months||||||
42283|NCT01430130|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks||||||
42284|NCT01430130|Secondary|Ease of Use||Up to 12 months||||||
42285|NCT01430130|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months||||||
42286|NCT01430130|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.~[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O’Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|6 months|Per protocol, all eligible patients who did not exit the study prematurely.||Units on a scale||Standard Error|Mean
42287|NCT01430104|Secondary|Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
42288|NCT01430104|Secondary|Concentrations of Serum 25-Hydroxy-Vitamin D||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
42289|NCT01430104|Secondary|Change From Baseline in Daily Urine Calcium Excreted||Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis.||grams per day (g/day)||Standard Deviation|Mean
42290|NCT01430104|Secondary|Mean Daily Urine Calcium Excreted||Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.||grams per day (g/day)||Standard Deviation|Mean
42291|NCT01430104|Secondary|Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline|Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.||participants|||Number
42292|NCT01430104|Secondary|Change From Baseline in Serum Calcium|Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were controlled for Day, Timepoint, Day*Timepoint, and random error. Postdose refers to after Teriparatide dose.|Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.||mg/dL||90% Confidence Interval|Least Squares Mean
42293|NCT01430104|Secondary|Mean Serum Calcium Levels|Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).|Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.||mg/dL||90% Confidence Interval|Least Squares Mean
42294|NCT01430104|Secondary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis.||participants|||Number
42295|NCT01430104|Primary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). Postdose refers to after Teriparatide dose.|Day 28 (16 and 24 hours postdose)|All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.||participants|||Number
43226|NCT01413204|Secondary|Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test||Week 24||||||
42299|NCT01429584|Secondary|Satisfaction With Pain Control|A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control.|Within 30 days|Same as other outcome measures||Likert Satisfaction Scale||Standard Deviation|Mean
42300|NCT01429584|Secondary|Pain Relief|Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Same as other outcome measures.||Visual Analogue Scale for pain||Standard Deviation|Mean
42301|NCT01429584|Primary|Abnormal Lung Function|Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Power analysis was performed and a drop-out rate of 10% was anticipated.||participants w/ abnormal diaphragm fxn|||Number
42302|NCT01429532|Primary|Surgically Induced Astigmatism|Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation.|post-operative week 1, post-operative month 1, and post-operative month 3|||Diopters||Standard Deviation|Mean
42303|NCT01429532|Secondary|Best-corrected Visual Acuity|The best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist, preoperatively and at postoperative 1 day, 1 week, 1 month and 3 months.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis.||logMAR||Standard Deviation|Mean
42304|NCT01429532|Primary|Central Cornea Endothelial Cell Loss|Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis and sample size calculation. Mean ultrasound time (UST), surgical time, cumulative dissipated energy (CDE), total BSS volume, and SIA were compared using multifactor analysis of variance.||% of endothelial cell loss||Standard Deviation|Mean
42305|NCT01429441|Secondary|Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24|≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.|Month 24|FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis.||Percentage (weighted across strata)||95% Confidence Interval|Number
42306|NCT01429441|Primary|Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28|Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.|Day 28|Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits.||Percentage (weighted across strata)||95% Confidence Interval|Number
42307|NCT01429259|Secondary|Meropenem Pharmacodynamics|Meropenem exposures defined from the population model for each participant will be analyzed as a function of the isolated pathogens meropenem minimum inhibitory concentration (MIC) to define the exposure of meropenem associated with an absolute and relative percent change in the Forced Expiratory Volume (FEV1).|14-21 days||||||
42308|NCT01429259|Secondary|Practicality of 3 Hour Prolonged Infusion|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be utilized to assess patient or parent assessments of the burden of the prolonged infusion treatment. The CFQ-R will be administered at the beginning of the study and then within 7 days after completion of meropenem therapy.|14-21 days||||||
42309|NCT01429259|Secondary|Safety|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. Participants will be monitored for any sign of symptom of adverse events throughout the course of the study. An adverse event will be defined as any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug.|14-21 days||||||
42310|NCT01429259|Primary|Population Pharmacokinetics - Volume of Central Compartment|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment.|During 8 hour dosing interval after 3rd meropenem dose|||L/kg||Standard Deviation|Mean
42311|NCT01429259|Primary|Population Pharmacokinetics - Total Body Clearance|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.|8 hour dosing interval after 3rd meropenem dose|||L/hr/kg||Standard Deviation|Mean
42312|NCT01429077|Secondary|Participation in Everyday Activities (Maintenance)||Change in participation in everyday activities from 6 weeks to 12 weeks||||||
42313|NCT01429077|Secondary|Functional Communication Skills (Maintenance)||Change in functional communication skills from 6 weeks to 12 weeks||||||
42314|NCT01429077|Secondary|Western Aphasia Battery Reading and Writing Scores (Maintenance)||Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks||||||
42315|NCT01429077|Secondary|Western Aphasia Battery Aphasia Quotient (Maintenance)||Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks||||||
42316|NCT01429077|Secondary|Western Aphasia Battery - Reading and Writing Scores||Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks||||||
42319|NCT01429077|Primary|Language Quotient (LQ) on the Western Aphasia Battery|"Includes a measure of auditory comprehension, oral expression, reading and written expression skills.~The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement."|Change from Baseline in Western Aphasia Battery LQ at 6 weeks|||units on a scale||Standard Deviation|Mean
42320|NCT01429064|Primary|Frequency of Adverse Events|Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.|From first dose of study treatment up to 4 weeks after last dose of study treatment|Safety population||participants|||Number
42321|NCT01429051|Secondary|Number of Participants With Adverse Events (AEs)|The severity (intensity of each AE was assessed as mild (transient symptoms, no interference with daily activities), moderate (marked symptoms, moderate interference with daily activities), or severe (considerable interference with daily activities) by the investigator. Serious adverse events are defined as any untoward medical occurrence that at any dose results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The investigator assessed each AE as either related or not related to study treatment.|12 weeks|Safety analysis set||participants|||Number
42322|NCT01429051|Secondary|Efficacy Phase: General Impression (GI) Score at 60 Minutes After First Dose|"Participants assessed their general impression (GI) of treatment efficacy for treated BTP episodes at 60 minutes after first dose of study drug. The validated, categorical 5-point Verbal Rating Scale (VRS) was used for this assessment and scored as follows:~0 =poor;~1 =fair;~2 =good;~3 =very good;~4 =excellent."|During the efficacy phase (II), at each episode of breakthrough pain, 60 minutes after first dose of study drug.|Efficacy Phase, Full Analysis Set||units on a scale||95% Confidence Interval|Least Squares Mean
42323|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 33% or 50% Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • Greater than 33% reduction in PI from time 0; • Greater than or equal to 50% reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set||proportion of breakthrough pain episodes|Participants||Number
42324|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 1, 2 or 3 Point Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • greater than or equal to 1 point reduction in pain intensity (PI) from time 0, • greater than or equal to 2 point reduction in PI from time 0, and • greater than or equal to 3 point reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set||proportion of breakthrough pain episodes|Participants||Number
42325|NCT01429051|Secondary|Efficacy Phase: Sum of Pain Intensity Differences (SPID0-60 and SPID0-30) Derived From PI Scores|"The SPID30 and SPID60 represent the average improvement in pain intensity over the 30 minute interval and 60 minute interval, respectively. SPIDt was calculated as the area under the curve (AUC) for Pain Intensity Difference over the time interval 0 to t minutes, respectively, divided by the length of the time interval (t minutes). A positive value is a decrease (improvement) of the pain.~Pain intensity was assessed at 0, 5, 30 and 60 minutes after study drug using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set||units on a scale||95% Confidence Interval|Least Squares Mean
42326|NCT01429051|Secondary|Efficacy Phase: Pain Intensity Difference (PID) at 5, 30, and 60 Minutes After First Dose of Study Drug|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0, 5, 30 and 60 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug.|Efficacy Phase, Full Analysis Set||units on a scale||95% Confidence Interval|Least Squares Mean
42327|NCT01429051|Secondary|Incidence of Improvement or Worsening in Nasal Mucosa Sign or Abnormality Score|Medical examination of the nasal cavity by rhinoscopy was performed by an oto-rhino-laryngologist before the start of study treatment and at 12 weeks. Signs and any abnormalities were observed for each nostril using the following 4 points assessment scale: • 0 =not present; • 1 =present in a mild degree; • 2 =present in a moderate degree; • 3 =present in a severe degree. A difference in score of 1 or more from Baseline to the end of treatment represented a worsening, while a negative value indicated an improvement of the observed clinical sign. The oto-rhino-laryngologist also assessed whether worsening of a sign was related to study drug. Assessments for both left and right nostrils are presented together. The incidence is calculated as the number of assessments (n) in the improvement or worsening category divided by the number of assessments with a non-missing score for the Nasal Mucosa or Abnormality assessment. Only those signs or abnormalities with n>0 were included|Baseline and at 12 weeks|Safety Analysis Set, which included all patients who received at least 1 dose of INFS (including the initial test dose) with non-missing assessments.||proportion of nostril assessments|Participants|95% Confidence Interval|Number
42352|NCT01428583|Other Pre-specified|Duration of Exposure to Study Medication|Duration of exposure to study medication during the course of the study was assessed.|Baseline up to 2 weeks after last dose|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||days||Full Range|Median
43227|NCT01413204|Secondary|Change in Blood Pressure||Week 24||||||
42328|NCT01429051|Primary|Induction Phase: Pain Intensity Difference at 10 Minutes (PID10) After Treatment|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 10 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II), at each episode of breakthrough pain, at 0 and 10 minutes after first dose of study drug.|The Full Analysis Set consisted of all randomly assigned participants who entered the Efficacy Phase (II) of the trial and were treated for at least 1 BTP episode with double-blind INFS in the Efficacy Phase of the trial.||units on a scale||95% Confidence Interval|Least Squares Mean
42329|NCT01428882|Secondary|Rate of Patients and Physician Satisfaction With Sedation|"Endoscopists and patients rated their satisfaction with sedation in a 10-cm visual analogue scale after discharge.The patients were contacted 24–48 h after the procedure to answer a questionnaire regarding if they remembered scope insertion or scope removal and willingness to repeat it with a similar protocol and rated their satisfaction and pain perception from 0 to 10. This phone survey was done by the nurse specifically making the measurements in the endoscopy room, who was blinded to the sedation regimen.~For the interpretation of results of the 0-10 point numerical scale, 0 stands for 'extremely dissatisfied with sedation level during the endoscopic procedure', whereas 10 stands for 'extremely satisfied with sedation level during the endoscopic procedure."|Up to 1 hour after colonoscopy for endoscopists and up to 48 hours for patients|||units on a scale||Full Range|Mean
42330|NCT01428882|Secondary|Rate of Sedation-related Complications During the Procedure and the Recovery Phases|The following events were considered complications of procedural sedation: a decline in oxygen saturation to less than 85 % longer than 30 s after increasing the oxygen flow rate to 5 L/min and transient propofol interruption, a heart rate less than 40 beats per minute and blood pressure less than 80/50 mmHg. Major complications were defined as need for mechanical ventilation or any cardiorespiratory event requiring anaesthesiologist assistance.|Up to two hours, including colonoscopy performance and recovery period|||participants|||Number
42331|NCT01428882|Secondary|Duration of Recovery After the Endoscopic Procedure|"After completion of the procedure, the patient stood in the examination room monitored continuously by a nurse. When patients responded to normal verbal command, they were asked to sit up and were offered a drink. This was considered the early recovery time.~If they were able to stand unassisted by the bed and had stable hemodynamics parameters (saturation>90 % on room air and blood pressure and heart rate within 20 % of baseline), they were transferred to a locker room accompanied by a relative. The discharge criteria included ability to stand unassisted and tolerate clear liquids once dressed. Once a patient met discharge criteria, they were allowed to leave at their own discretion"|Up to 1 hour after colonoscopy|||minutes||Full Range|Mean
42332|NCT01428882|Primary|Level of Sedation Throughout the Entire Procedure|Assessment every two minutes of the level of sedation during the endoscopic procedure, rating it as minimal, moderate or deep.|Up to 1 hour after introduction of the colonoscope|||participants|||Number
42333|NCT01428765|Primary|Concomitant Medication||Baseline|||participants|||Number
42334|NCT01428765|Primary|Medical History||Baseline|||participants|||Number
42335|NCT01428765|Primary|Age Group||Baseline|||participants|||Number
42336|NCT01428765|Primary|Gender||Baseline|||participants|||Number
42337|NCT01428765|Primary|Antithrombotic Treatment Choice at Baseline||Baseline|||participants|||Number
42338|NCT01428765|Primary|HAS-BLED Risk Score|The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.|Baseline|||participants|||Number
42339|NCT01428765|Primary|CHA2DS2-VASc Score|The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65–74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to “low risk”, a score of 1 corresponds to “intermediate risk”, and a score of 2 or more corresponds to “high risk”.|Baseline|||participants|||Number
42340|NCT01428765|Primary|CHADS2 Score|CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).|Baseline|||participants|||Number
42341|NCT01428713|Primary|To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.|"To assess~change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of TA~change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of TA~change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of COCP~change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of COCP~PBAC score:~Quantitative score to measure menstrual blood loss. Scale range: Minimum - 0 score, Maximum: No maximum Interpretation: Score > 100 indicates heavy menstrual bleeding~Peds QL score:~Score to measure quality of life in children Scale range: Minimum: 0, Maximum 100 Calculation: Subscales are reverse scored (using formula 100 - a x 25) and then all subscales are averaged Eg: Subscale score of 3 is reverse scored as: 100 - (3 x 25) = 25 Interpretation: Higher score indicates better quality of life"|Baseline, 3 cycles|10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.||Scores on a scale||Standard Error|Mean
42369|NCT01428219|Primary|Percentage of Participants Who Remain Progression-free at 12 Weeks|Efficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study.|12 weeks after participant initiates study|||Percentage of participants||95% Confidence Interval|Number
43228|NCT01413204|Secondary|Change in Body Weight||Week 24||||||
42342|NCT01428661|Primary|Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)|Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.|8 weeks|The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.||units on a scale||Standard Error|Mean
42343|NCT01428583|Other Pre-specified|Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. “Pain at its worst in the last 24 hours” was reported.|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||unit on a scale||Standard Deviation|Mean
42344|NCT01428583|Other Pre-specified|Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours was reported."|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||unit on a scale||Standard Deviation|Mean
42345|NCT01428583|Other Pre-specified|Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. “Pain right now” was reported.|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||units on a scale||Standard Deviation|Mean
42346|NCT01428583|Other Pre-specified|Participants Global Assessment of Treatment Satisfaction|"Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question Please rate your overall satisfaction with the study drug you received?” where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied."|Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||unit on a scale||Standard Deviation|Mean
42347|NCT01428583|Other Pre-specified|Mean Daily Dose of Immediate-release Oxycodone as Rescue Medication|Immediate-release oxycodone as a single ingredient product was used as a rescue medication only during the first 4 weeks of the treatment period to support the initiation of oxycodone HCl and naltrexone HCl treatment.|Up to Week 4|Data for mean daily dose of immediate-release oxycodone was not reported because as per protocol and analysis plan it was not planned to be summarized.|||||
42348|NCT01428583|Other Pre-specified|Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above|The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior.|Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."||percentage of participants|||Number
42349|NCT01428583|Other Pre-specified|Percentage of Participants With Response to Urine Drug Test|Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed.|Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||percentage of participants|||Number
42350|NCT01428583|Other Pre-specified|Number of Participants With Rescue Medication (Acetaminophen Tablets)|Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication.|Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Intent-to-treat (ITT) included all participants in the safety analysis set who had at least 1 pain intensity score reported during treatment. Here n signifies those participants who were evaluable at specified time point."||participants|||Number
42351|NCT01428583|Other Pre-specified|Mean Daily Dose of Study Medication (Oxycodone Component)||Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."||milligram/day||Standard Deviation|Mean
42353|NCT01428583|Other Pre-specified|Time to Stabilization of Study Medication|Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1.|Baseline up to Month 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."||days||Full Range|Median
42354|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of 6-Beta-naltrexol|6-Beta-naltrexol was a metabolite of naltrexone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
42355|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
42356|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone|Noroxycodone was a metabolite of Oxycodone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
42357|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.|||||
42358|NCT01428583|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.|Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."||units on a scale||Standard Deviation|Mean
42359|NCT01428583|Secondary|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.|Baseline up to Month 12|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||percentage of participants|||Number
42360|NCT01428583|Secondary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant’s usual function) and severe (interferes significantly with participant’s usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||participants|||Number
42361|NCT01428583|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.||participants|||Number
42362|NCT01428219|Secondary|Time-to-progression.||18 months||||||
42363|NCT01428219|Secondary|Change in Serum PSA With Treatment of Cabozantinib|PSA response.|18 months||10/2016||||
42364|NCT01428219|Secondary|Duration of Response.||18 months||||||
42365|NCT01428219|Secondary|Response Proportion in Both Soft Tissue and Bone Disease.||18 months||||||
42366|NCT01428219|Secondary|Progression-free Survival Time||18 months||10/2016||||
42367|NCT01428219|Secondary|Change in Bone Metabolism Biomarker Expression With Cabozantinib|"Changes in markers of bone metabolism in bone and serum with cabozantinib.~Changes in MET, AKT and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells from bone biopsy specimens with cabozantinib.~Changes in perfusion and diffusion MRI and CT images in bone lesions with cabozantinib and correlate those with response."|18 months||10/2016||||
42368|NCT01428219|Secondary|Incidence of Adverse Events (AEs) Related to Treatment|Toxicity will be analyzed.|18 months||10/2016||||
42370|NCT01428128|Secondary|Complete Blood Count (CBC)|Another objective of this trial is to assess if arsenic protects the blood counts that are adversely affected by chemotherapy|Day 9 of chemotherapy||||||
42372|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) – Depression Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||participants|||Number
42373|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) – Anxiety Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||participants|||Number
42374|NCT01428115|Secondary|State Trait Anxiety Index (STAI) Trait Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||scores on a scale||Standard Deviation|Mean
42375|NCT01428115|Secondary|State Trait Anxiety Index (STAI) State Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||scores on a scale||Standard Deviation|Mean
42376|NCT01428115|Secondary|Harvey-Bradshaw Index (HBI) Scores by Visit|Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn’s disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||participants|||Number
42377|NCT01428115|Secondary|Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit|The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.||scores on a scale||Standard Deviation|Mean
42378|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) – Depression, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||participants|||Number
42379|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) – Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||participants|||Number
42380|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||scores on a scale||Standard Deviation|Mean
42381|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.||scores on a scale||Standard Deviation|Mean
42382|NCT01428076|Primary|Weight-adjusted Polidocanol Cmax (Serum)|Cmax measured and adjusted for weight|pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose|PK population||ng/mL||Standard Deviation|Mean
43229|NCT01413204|Secondary|Change in Fasting Plasma Glucose||Week 24||||||
42383|NCT01428063|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Participants|||Number
42384|NCT01428063|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.|Week 24 (Follow-up)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
42385|NCT01428063|Secondary|Percentage of Participants With End of the Treatment Response (EOTR)|EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.|End of the study (Week 24)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
42386|NCT01428063|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.|Week 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
42387|NCT01428063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.|Week 4 and 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
42388|NCT01428063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4|RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.|Week 4|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.||Percentage of participants|||Number
42389|NCT01428063|Secondary|Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis||Percentage of participants||95% Confidence Interval|Number
42390|NCT01428063|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)|SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.|Week 12 (Follow-up period)|Participants with genotype 1 HCV who received at least 1 dose of study drug||Percentage of participants||95% Confidence Interval|Number
42391|NCT01427933|Other Pre-specified|Number of Participants With Adverse Events (AE) and Participants Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to end of treatment and within 30 days of last dose of study drug (22.6 months)|All randomized participants who received at least 1 dose of study drug and according to the treatment received.||participants|||Number
42392|NCT01427933|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who developed treatment-emergent antibody responses after baseline. The antibody test can produce positive results in participants without ramucirumab exposure. Treatment emergent anti-ramucirumab antibody positive was defined as: when baseline titer was greater than 0 and post baseline titer was equal to or greater than 4-fold the baseline titer or if the baseline titer was not detected and post baseline titer is equal to or greater than a value of 20.|Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 months|All randomized participants who received at least 1 dose of study drug and assessed for treatment emergent antibodies.||participants|||Number
42393|NCT01427933|Secondary|Change in Tumor Size (CTS)|CTS was defines as the change from baseline measurement of target lesions to the post treatment measurement in participants with measurable disease. Change was assessed using radiographic imagining. Log ratio calculated as: log of (tumor size post baseline) divided by (tumor size at baseline). A negative result indicated a shrinking tumor.|Baseline, 6 weeks|All participants with measurable disease at baseline and at 6 weeks.||log ratio||Standard Deviation|Mean
42394|NCT01427933|Secondary|Duration of Response (DOR) Time of Response to Progressive Disease|DOR was measured from the time criteria were met for first objectively recorded CR or PR until first date criteria for PD was met or death. Response defined using RECIST v1.1 criteria. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of diameter (SOD) of target lesions. PD defined ≥20% increase in SOD of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time from Observed CR or PR to PD up to 12.1 months|ITT population: all participants according to their randomized treatment group and who had CR or PR. Participants censored: Ramucirumab+Eribulin=1, Eribulin=3.||months||95% Confidence Interval|Median
42407|NCT01427803|Secondary|Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.|28 days|Participants in Patterns of Use cohort who took the product||Percentage of participants|||Number
42395|NCT01427933|Secondary|Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)|ORR was defined as the percentage of participants with measurable disease achieving a best overall response of PR or CR as defined by RECIST v.1.1. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in SOD of target lesions. Participants who did not have any post baseline tumor response assessments for any reason were considered non-responders and included in the denominator when calculating the response rate. ORR for each treatment arm calculated as: [(CR + PR in the treatment arm) divided by (total number of participants in the treatment arm)] x 100.|Start of treatment until documented CR or PR up to 16.5 months|ITT population: all participants according to their randomized treatment group.||percentage of participants||95% Confidence Interval|Number
42396|NCT01427933|Secondary|Overall Survival (OS) Randomization to Date of Death From Any Cause|Time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date, OS data were censored on the last date the participants were known to be alive prior to that cut-off date.|Randomization to date of death from any cause up to 28.6 months|ITT Population: All randomized participants. Participants censored: Ramucirumab and Eribulin=24 , Eribulin Monotherapy=28||Months||95% Confidence Interval|Median
42397|NCT01427933|Primary|Progression‐Free Survival (PFS)|PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.|Start of treatment until documented disease progression or death from any cause up to 16.5 months|Intent-to-treat Population (ITT): all participants according to their randomized treatment group. Participants censored: Ramucirumab+Eribulin=14; Eribulin=17.||months||95% Confidence Interval|Median
42398|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 17 subjects did not contribute to data.||scores on a scale||Standard Deviation|Mean
42399|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 4|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 20 subjects did not contribute to data.||scores on a scale||Standard Deviation|Mean
42400|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 0|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 10 subjects did not contribute to data.||scores on a scale||Standard Deviation|Mean
42401|NCT01427920|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to week 20|Safety analysis set included all subjects who received at least one dose of BIAsp 30. One subject did not contribute to data.||episodes|||Number
42402|NCT01427920|Secondary|Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)|Estimated mean change from baseline in FPG after 20 Weeks of treatment|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.||mmol/L||Standard Error|Least Squares Mean
42403|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - PP|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.|Week 0, week 20|Per protocol (PP) analysis set - analysis included subjects exposed to BIAsp 30 for more than 12 weeks without any major protocol violations. 24 subjects did not contribute to the statistical analysis after Week 20.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
42404|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - FAS|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 Weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
42405|NCT01427907|Primary|Serum Phosphorus Levels|The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject|2 weeks|Modified intent-to-treat: subjects who were randomized, received at least one prescribed dose of the study medication and provided at least one of the last 4 laboratory assessments of each treatment period||mg/dL||Standard Deviation|Mean
42408|NCT01427803|Secondary|Percentage of Dosing Occasions Where More Than One Tablet Was Taken|Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product||Percentage of dosing occasions|Participants||Number
42409|NCT01427803|Secondary|Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken|Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product||Percentage of participants|||Number
42410|NCT01427803|Secondary|Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day|Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product||Percentage of participants|||Number
42411|NCT01427803|Secondary|Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days|Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product||Percentage of participants|||Number
42412|NCT01427803|Secondary|Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course|This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by “use day”. A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive “evaluable days.”|28 days|Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population||Percentage of participants|||Number
42413|NCT01427803|Secondary|Non-therapeutic Reasons for Misuse|Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.|28 days|Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis||Participants|||Number
42414|NCT01427803|Primary|Estimated Percentage of Misuse for Non-Therapeutic Reasons|The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.|28 days|Participants in Patterns of Use cohort who took the product + Participants in Reason for Misuse cohort who completed interview||Percentage of Participants|||Number
42415|NCT01427751|Secondary|Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure|Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.|12 Months|Intent-to-treat population included all randomized participants.||percentage of participants|||Number
42416|NCT01427751|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)|The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||score on a scale||Standard Deviation|Mean
42417|NCT01427751|Secondary|Time to BCVA Improvement of 15-or-More Letters|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.|12 Months|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||days||Standard Deviation|Mean
42418|NCT01427751|Secondary|Percentage of Patients With a 15-or-More Letter Decrease in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||percentage of participants|||Number
42419|NCT01427751|Secondary|Percentage of Patients With 15-or-More Letter Improvement in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||percentage of participants|||Number
42420|NCT01427751|Secondary|Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||microns||Standard Deviation|Mean
42421|NCT01427751|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.||letters||Standard Deviation|Mean
42422|NCT01427738|Secondary|Number of Participants Who Found GV and Nystatin Acceptable.|Acceptability was defined as the willingness to use the drug if it is proven effective to treat oral candidiasis. Participants were asked whether or not they would be willing to use the assigned treatment via questionnaires.|After 14 days of treatment|The analysis for acceptability of treatment was based on 209 subjects.||participants|||Number
42423|NCT01427738|Secondary|Self-Assessment of General Health|Participants rated their general health on two scales. One is a five point scale ranging from 1 to 5 (1=Excellent; 2=Very Good; 3=Good; 4=Fair; 5=Poor)|Weeks 0, 6|N=110 (GV), 110 (Nystatin) wk 0 N= 96 (GV), 95 (Nystatin) wk 6||participants|||Number
42424|NCT01427738|Secondary|Number of Participants Who Were Adherent.|Adherence was reported as a dichotomous variable (adherence vs. non-adherence). Participants who have missing doses less than 15% will be considered as adherent, i.e., if a participant is in the GV arm, then the cutoff point is 28*0.15=4 doses; and for the nystatin arm is 56*0.15=8 doses.|After 14 days of treatment|The analysis for adherence was based on 209 observations.||participants|||Number
42425|NCT01427738|Secondary|Tolerance|The investigators will measure tolerance using a scale from 0 to 3 (0=No side effects experienced, no changes in treatment; 1=Some side effects experienced, but not enough to modify treatment; 2=Some side effects experienced, resulted in treatment interruption; 3=Side effects experienced, resulted in treatment discontinuation.)|After 14 days of treatment|The analysis for tolerance was based on 208 observations.||participants|||Number
42426|NCT01427738|Secondary|Quantitative Yeast Colony Counts|If quantitative yeast culture yielding < 20 CFU/mL of Candida spp., then we call this mycological success|At weeks 0, 2, 6|"At entry, 210 observations were available (182 had positive culture result for Candida specimen, and 175 of those had colony count performed) to evaluate quantitative yeast colony counts.~N= 78 (GV), 70 (Nystatin) at end of treatment; N= 51 (GV), 35 (Nystatin) at week 6;"||CFU/mL||Standard Deviation|Mean
42427|NCT01427738|Secondary|Number of Participant With Symptom|Symptoms were assessed using a visual analog scale where the level of discomfort and pain were recorded and quantified using a scoring system from 0 to 3. 0=no discomfort/pain; 1=mild discomfort/pain; 2=Moderate discomfort/pain; 3=Severe discomfort/pain.|after 14 days of treatment|At entry, a total of 217 observations (106 in GV arm; 111 in nystatin arm) were available to evaluate the symptoms (pain and discomfort) associated with OC. At the end of treatment, a total of 204 observations were available to evaluate the symptoms associated with OC using extended Mantel-Haenszel test between GV and nystatin arms.||participants|||Number
42428|NCT01427738|Primary|Number of Participants With Clinical Efficacy|The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.|After 14 days of treatment|Out of 221 subjects,17 had oral exams at entry but not week 2: 11 premature discontinuation, 2 missed visits, and 4 without specific reasons. 204 subjects received oral exams at both entry and week 2. 2 more participants were excluded from the final analysis because they had no pseudomem candi at entry, which led to a total of 202 subjects.||participants|||Number
42429|NCT01427517|Primary|Brain GSH|change in brain GSH levels from baseline to post-NAC administration (90 - 110 minutes) in all subjects|Baseline and up to 110 minutes post-NAC administration|||percent increase from baseline||Standard Deviation|Mean
42430|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
42431|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
42432|NCT01427504|Primary|Etravirine AUC Pharmacokinetics Coadministered With Boceprevir|Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
42433|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics Coadministered With Etravirine|Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
42434|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine|Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
42435|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics Coadministered With Etravirine|Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||Ratio||90% Confidence Interval|Geometric Mean
42436|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics|Determine etravirine Cmin when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
42437|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics|Determine etravirine Cmax when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
43230|NCT01413204|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||baseline and 24 weeks|Full analysis set, last observation carried forward||percent HbA1C||Standard Error|Least Squares Mean
43231|NCT01413191|Secondary|Tumor Shrinkage for All Efficacy-evaluable Patients||Up to 2 years||||||
42438|NCT01427504|Primary|Etravirine AUC Pharmacokinetics|Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
42439|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics|Determine boceprevir 8 hour concentration when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
42440|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics|Determine the Cmax of boceprevir when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
42441|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics|Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants was based on the number of subjects that completed all three sequences of medication.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
42442|NCT01427309|Other Pre-specified|Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period|All serious adverse events, including deaths and adverse events (AEs) of special interest (Guillain Barre Syndrome, Bell's Palsy, encephalitis/myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis) were collected.|Day 0 up to Day 240 post-vaccination|Safety was assessed in the Full Analysis Set.||Participants|||Number
42443|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture).~Respiratory illness is defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
42444|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~Respiratory illness was defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
42445|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
42446|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.||Participants|||Number
42468|NCT01426516|Secondary|Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.|Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.|one week||||||
43232|NCT01413191|Secondary|Overall Survival (OS)||Up to 2 years||||||
43233|NCT01413191|Secondary|Progression-free Survival (PFS)||Up to 2 years||||||
42447|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness|"For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture).~A protocol-defined influenza-like illness (ILI) was determined by the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a protocol-defined influenza-like illness was assessed in the Per-Protocol Analysis Set.||Participants|||Number
42448|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)|Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture. For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).||Participants|||Number
42449|NCT01427309|Primary|Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).|"Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type–specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration through a 510K evaluation for specific detection of Influenza A, B or Respiratory Syncytial Virus.~A protocol-defined influenza-like illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).||Participants|||Number
42450|NCT01426958|Primary|Area Under Curve From 0 to ∞ Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
42451|NCT01426958|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
42452|NCT01426958|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
42453|NCT01426867|Primary|Mean Ocular Discomfort Score|Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).|Week 1|Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.||Units on a scale||Standard Deviation|Mean
42454|NCT01426854|Secondary|Proportion of Subjects Who Were Pain-Free at All Postoperative Visits|Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.|Up to Day 14|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.||Percentage of subjects|||Number
42514|NCT01425853|Secondary|Number of Adverse Events Defined by Relationship With Treatment|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population||number of events|||Number
42515|NCT01425853|Secondary|Number of Participants With at Least One Adverse Events|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population||number of participants|||Number
42455|NCT01426854|Primary|Proportion of Subjects With Clinical Cure at Day 14|Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.|Day 14 postoperative|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.||Percentage of subjects|||Number
42456|NCT01426789|Secondary|Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis. Statistical analysis was not done on the other biomarkers: osteoprotegerin (OPG), rheumatoid factor (RF), anti-cyclic citrullinated peptide antibodies (CCP) and hsCRP. Therefore, data is provided for the alleles only.||score on a scale||Standard Error|Least Squares Mean
42457|NCT01426789|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.||Percentage of participants|||Number
42458|NCT01426789|Primary|Change From Baseline in Disease Activity Score 28 (DAS28) in Association With the Presence or Absence of HLA-DRB1 04|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis.||score on a scale||Standard Error|Least Squares Mean
42459|NCT01426789|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.||Percentage of participants|||Number
42460|NCT01426763|Secondary|Number of Subjects With C1 INH Antibodies||Through 30 days after final dose||||||
42461|NCT01426763|Secondary|C1 Inhibitor (C1 INH) and C4 Levels||18 days||||||
42462|NCT01426763|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study||18 days|||participants|||Number
42463|NCT01426555|Secondary|Validation of DXA Scanning in Patients With SCI|This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia.|12 months|Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB.|||||
42464|NCT01426555|Primary|Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure|This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid.|12 months|Data was never analyzed because the study was closed by the VABHS IRB. Full dataset is unavailable for analysis.|||||
42465|NCT01426516|Secondary|Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey|To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder|6 months||||||
42466|NCT01426516|Secondary|Cost|To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.|6 months||||||
42467|NCT01426516|Secondary|Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.|baseline, 3, 6 months||||||
49781|NCT01324882|Primary|Intubation of Cecum|The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.|(day 1) Within time for performance of colonoscopy||||||
42469|NCT01426516|Primary|Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months|"To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months~Add:~highest score on any 1 of the 4 sleep items (items 1 to 4)~highest score on any 1 of the 4 weight items (items 6 to 9)~highest score on either of the 2 psychomotor items (15 and 16)~scores for each of the 6 MDD symptom domains~Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression"|6 months|Invalid Data Collection|||||
42470|NCT01426438|Secondary|Change in D-Dimer|Change in D-Dimer from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||ug/ml||Inter-Quartile Range|Median
42471|NCT01426438|Secondary|Change in C-reactive Protein (CRP)|Change in C-reactive protein from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||ug/ml||Inter-Quartile Range|Median
42472|NCT01426438|Secondary|Change in IL-6|Change in IL-6 from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||pg/ml||Inter-Quartile Range|Median
42473|NCT01426438|Secondary|Change in HOMA-IR|Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||HOMA IR Score||Inter-Quartile Range|Median
42474|NCT01426438|Secondary|Change in Large HDL Particles|Change in Large HDL Particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||nmol/L||Inter-Quartile Range|Median
42475|NCT01426438|Secondary|Change in Small LDL Particles|Change in Small LDL particles from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||nmol/L||Inter-Quartile Range|Median
42476|NCT01426438|Secondary|Change in LDL Cholesterol|Change in LDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
42477|NCT01426438|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
42478|NCT01426438|Secondary|Change in HDL Particles|Change in total HDL particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||nmol/L||Inter-Quartile Range|Median
42479|NCT01426438|Secondary|Women: Change in HDL Cholesterol|Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Women in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
42480|NCT01426438|Secondary|Men: Change in HDL Cholesterol|Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Men in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
42481|NCT01426438|Secondary|Change in Triglycerides|Change in Triglycerides (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||mg/dL||Inter-Quartile Range|Median
42482|NCT01426438|Secondary|Change in Cholesterol|Absolute change in total cholesterol from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan and had lipid panels at weeks 0 and 24.||mg/dL||Inter-Quartile Range|Median
42483|NCT01426438|Primary|Absolute Change in Relative FMD (%)|The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.||% FMD||Inter-Quartile Range|Median
42484|NCT01426373|Secondary|Change From Baseline in Line Drawing Assessment|Each participant was given 2 example line drawings representing each of the 5 submental fat grades (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme) and asked to select the drawing that best represents their current profile. Improvement is any decrease in grade, and worsening is any increase in grade.|Baseline and month 3 after last treatment|Treatment effect population with available data||participants|||Number
42485|NCT01426373|Secondary|Change From Baseline in Submental Skin Laxity Grade (SMSLG)|"SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds).~Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy (no skin draping (vertical folds) or skin sagging (horizontal folds));~Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy (slight skin draping and sagging);~Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy (moderate skin draping and skin sagging);~Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy (marked skin draping and sagging)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"||units on a scale||Standard Deviation|Mean
42486|NCT01426373|Secondary|Percent Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured using calipers.|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (164) and at each time point||percent change||Standard Deviation|Mean
42487|NCT01426373|Secondary|Response to Subject Global Questions|"Participants answered 3 questions on a 7-point scale that ranged from a great deal worse to a great deal better (questions 1 and 2) or from extremely dissatisfied to extremely satisfied (question 3).~Question 1: Since the start of the study, how would you rate the fat under your chin right now?~Question 2: Since the start of the study, how would you rate the definition between your chin and neck right now?~Question 3: How satisfied are you with the treatment you received in this study?"|Month 3 and month 12 after last treatment|Treatment effect population with available data at each time point||participants|||Number
42488|NCT01426373|Secondary|Mean Change From Baseline in Self-rating of Attractiveness|"Self-rating of Attractiveness assesses aspects of appearance from the participant's perspective with a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 (1 = not at all attractive, 5 = neither attractive nor unattractive, and 9 = extremely attractive). A positive change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (163), month 3 (144), and month 12 (130)||units on a scale||Standard Deviation|Mean
42489|NCT01426373|Secondary|Mean Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 (0 = extremely dissatisfied, 1 = dissatisfied, 2 = slightly dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = slightly satisfied, 5 = satisfied and 6 = extremely satisfied). A positive change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"||units on a scale||Standard Deviation|Mean
42490|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and each time point (indicated by n)"||units on a scale||Standard Deviation|Mean
42491|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"||percentage of participants|||Number
42492|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"||percentage of participants|||Number
42493|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat). A negative change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline (163) and at each time point (indicated by n)"||units on a scale||Standard Deviation|Mean
42494|NCT01426373|Secondary|Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement.|Baseline and months 3, 6, 9, and 12 after last treatment|"Treatment effect population (all participants who received at least 1 injection with study drug and had any posttreatment data for treatment effect variables or for the submental skin laxity grade) and with available data at each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
42495|NCT01426373|Primary|Number of Participants With Adverse Events (AEs)|"Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard.~The severity of each AE was defined as either:~Mild: The participant was aware of the sign or symptom, but it was easily tolerated.~Moderate: The sign or symptom caused discomfort and interfered with usual activity.~Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity.~The investigator determined the relationship of each AE to the study drug using the question: “Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"|Up to 12 months after last treatment (maximum of 18 months from first treatment)|Safety population||participants|||Number
42496|NCT01426360|Primary|Air Blast Hypersensitivity Score 3 Days After Dentifrice Use|"After 3 days, tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.~0 - Subject does not respond to air stimulus;~- Subject responds to air stimulus, but does not request discontinuation of stimulus;~- Subject responds to air stimulus and requests discontinuation or moves from stimulus;~- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|3 days after dentifrice use|||scale||Standard Deviation|Mean
42529|NCT01425749|Secondary|Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.|Antibody responses were assessed in serum by ELISA, assay for IgG. Seroconversion was defined as a detectable Ab response by ELISA (>20 EU/ml).|Over 6 months, typically weeks 1, 7, 13, 26|All eligible participants.||percentage of evaluable participantes|||Number
42497|NCT01426360|Primary|Tactile Hypersensitivity Score After 3 Days of Dentifrice Use|After 3 days, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified, reproducible force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|3 days after dentifrice use|||gram||Standard Deviation|Mean
42498|NCT01426360|Primary|Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use|"The tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at the exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.~0 - Subject does not respond to air stimulus;~- Subject responds to air stimulus, but does not request discontinuation of stimulus;~- Subject responds to air stimulus and requests discontinuation or moves from stimulus;~- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|immediately after dentifrice use|||scale||Standard Deviation|Mean
42499|NCT01426360|Primary|Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use|Immediately after dentifice use, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|immediately after dentifrice use|||gram||Standard Deviation|Mean
42500|NCT01426269|Other Pre-specified|Period 1: Tolerability (Dryness)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)|||participants|||Number
42501|NCT01426269|Other Pre-specified|Period 1: Tolerability (Stinging/Burning)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)|||participants|||Number
42502|NCT01426269|Other Pre-specified|Period 1: Tolerability (Scaling)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)|||participants|||Number
42503|NCT01426269|Secondary|Period 2: Inflammatory Lesion Count|The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.|Period 2 (40 Weeks)|||lesions||Standard Deviation|Mean
42504|NCT01426269|Secondary|Period 2: Clinician's Erythema Assessment|The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score.|Period 2 (40 Weeks)|||units on a scale||Standard Deviation|Mean
42505|NCT01426269|Secondary|Period 2: Investigator's Global Assessment Success|The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score).|Period 2 (40 weeks)|||participants|||Number
42506|NCT01426269|Primary|Period 2: Number of Subjects Who Relapsed|"Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria:~A return to the baseline lesion count~A return to the baseline IGA score~The investigator determines that a change in rosacea treatment is warranted due to the subject’s clinical condition. The numbers reported here are accumulative numbers for each arm."|Period 2 (40 weeks)|||participants|||Number
42507|NCT01426230|Primary|Change From Baseline to End of Study in LOCF VAS|"Change from baseline in pain score on visual analog scale (VAS) (intensity scored from No Pain (0mm) to Worst Possible Pain (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis"|8 weeks (Baseline and Week 8)|The Number of Participants Analyzed was based on the available VAS.||scores on a scale||95% Confidence Interval|Mean
42508|NCT01426113|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 6|Due to early termination of the study, no statistical analysis was performed and no data summaries were generated. From a target of 120 patients, only 6 patients (3 in each group) were enrolled.|||||
42509|NCT01425879|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment|||months||95% Confidence Interval|Mean
42510|NCT01425879|Secondary|Overall Survival|Analyzed using Kaplan-Meier method.|From study initiation to time of death, assessed up to 4 weeks after completion of study treatment|||months||95% Confidence Interval|Median
42511|NCT01425879|Secondary|Frequency of Adverse Events Related to MK-2206|Severity of adverse events is graded according to the NCI CTCAE 4.0.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year|||percentage of patients|||Number
42512|NCT01425879|Primary|Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year|||patients|||Number
42513|NCT01425853|Secondary|Biomarker Analysis|The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2|6 months||||||
49782|NCT01324687|Secondary|Cost of Care|Comparison of cost of care between intervention and control groups.|Up to 36 months||12/2016||||
42516|NCT01425853|Secondary|Health Status According to EuroQoL|"EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits.~The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3.~The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ and ‘Worst imaginable health state’. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.~Total scale range for VAS dimension reported is 0 to 100."|6 months|ADO on PP population||points||Standard Deviation|Mean
42517|NCT01425853|Secondary|Patient’s and Investigator's Global Assessment of Response to Therapy|The investigator were asked to evaluated the patient’s response to therapy of the index knee by marking a (I) a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Left hand marker “Excellent-Best possible anticipated response, considering the severity and stage of the disease”, right hand marker “None-no response, absence of drug effect”.|6 months|Investigator and Patient's global assessment assessment of response to therapy. ADO on PP population.||units on a scale||Standard Deviation|Mean
42518|NCT01425853|Secondary|Patient’s Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity|Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: “Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing.” Left hand marker “Very Well”, Right hand marked “Very Poor”.|6 months|Patient and Investigator's global assessment of disease activity. ADO on PP population||units on a scale||Standard Deviation|Mean
42519|NCT01425853|Secondary|Consumption of Rescue Medication|"Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary.~Total Number of pills per month"|6 months|Consumption of rescue medication (number of daily tablets consumed). ADO on PP population. daily tablets consumed/month||daily tablets consumed/month||Standard Deviation|Mean
42520|NCT01425853|Secondary|Percentage of Presence of Joint Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population||percentage of participants|||Number
42521|NCT01425853|Secondary|Percentage of Presence of Joint Swelling|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population||percentage of participants|||Number
42522|NCT01425853|Secondary|Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)|"The OARSI Standing Committee for Clinical Trials Response Criteria Initiative and the OMERACT committee, in concert with the international rheumatology community, has led to the development of a uniform core set of outcome measures for OA. One of the objectives was to propose a set of criteria for measurement based on multiple domains to present the results of changes after treatment in symptomatic parameters as a single variable for clinical trials.~To be considered as responder patients should met one the following criteria:~High improvement in pain or in function ≥ 50% and absolute change ≥ 20 or~Improvement in at least 2 of the 3 following:~Pain ≥ 20% and absolute change ≥ 10~Function ≥ 20% and absolute change ≥ 10~Patient’s global assessment ≥ 20% and absolute change ≥ 10"|6 months|ADO on PP population||percentage of participants|||Number
42523|NCT01425853|Secondary|Huskisson’s VAS|Visual Analogue Scale: 0 No Pain 100 Maximum Pain Huskisson’s VAS measures global pain intensity. Patients were asked to quantify their disease status on a 100 mm VAS as follows: “Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line”. Left hand marker represents “No pain” and right hand marker represents “The worst pain imaginable”.|6 months|ADO on PP population||units on a scale||Standard Deviation|Mean
42524|NCT01425853|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 1700 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.|6 months|||units on a scale||Standard Deviation|Mean
42525|NCT01425853|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 200 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.|6 months|ADO on PP population||units on a scale||Standard Deviation|Mean
42526|NCT01425853|Primary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.|6 months|Imputed data on PP population||units on a scale||Standard Deviation|Mean
42527|NCT01425749|Secondary|A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).|Cells per mm^2 in the superficial dermis at the vaccine site microenvironment, by enumeration of immunohistochemically stained slides. Biopsies of the vaccine sites were taken at week 1 (1 week after the first vaccine) and week 7 (1 week after the 3rd vaccine). This only was evaluable in Arm B patients.|Over 6 months|Participants enrolled on Arm B who had sufficient biopsy site samples.||cells per mm^2 of dermis||Standard Deviation|Mean
42528|NCT01425749|Secondary|Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.|Number of CD83+ cells (mature DC) and CD1a+ cells (immature DC/Langerhans cells) per mm^2 in cross-sections of sentinel immunized nodes|Over 3 weeks|Evaluable patients with sufficient node sample for the analysis of DC infiltrates.||cells per mm^2 in SIN||Standard Deviation|Mean
42530|NCT01425749|Secondary|Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.|The analysis determined the proportion of CD4+ (and/or CD8+) T cells producing IFN-gamma or TNFα, or both, in response to MAGE-A3 peptide pools (with irrelevant peptide as negative control). T cell response was defined when T cells producing both IFNγ and TNFα in response to MAGE-A3 peptides exceeded (a) twice the maximum of 2 negative controls (PRAME peptides, media only), corrected for pre-existing response; and (b) exceeded the negative controls by at least 0.2% of the T cell population. These criteria also were used to define immunogenicity by ELIspot (IFNγ only). If the negative control values for a given sample were zero, a meaningful fold-increase could not be calculated; so, in those cases, we used the minimum detectable value among all similar assays (0.06%) as the negative control value for that sample.|Over 6 months|All eligible patients with evaluable peripheral blood mononuclear cells; this corresponds to all enrolled patients.||participants|||Number
42531|NCT01425749|Primary|Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.|Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.|One week after 3 doses of study drug, on day 22.|Eligible participants with evaluable sentinel immunized node specimens.||participants|||Number
42532|NCT01425749|Primary|Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability|grade 2 treatment-related adverse events graded by CTCAE v4|Over 6 months|All eligible patients.||participants|||Number
42533|NCT01425632|Secondary|Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)||Week 2||||||
42534|NCT01425632|Secondary|Adverse Events and Adverse Drug Reactions||Week 2||||||
42535|NCT01425632|Secondary|Change From Baseline in Severity Score||Week 2||||||
42536|NCT01425632|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Week 2||||||
42537|NCT01425632|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||Week 2||||||
42538|NCT01425632|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||Week 2||||||
42539|NCT01425632|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .|Baseline and Week 2|||units on a scale||Standard Error|Least Squares Mean
42540|NCT01425528|Secondary|Pittsburgh Sleep Quality Index||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
42541|NCT01425528|Secondary|Brief Symptom Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
42542|NCT01425528|Secondary|Beck Depression Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
42543|NCT01425528|Secondary|Behavior Rating Inventory of Executive Function (BRIEF) Adult Version||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
42544|NCT01425528|Secondary|Hamilton Depression Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
42545|NCT01425528|Secondary|Hamilton Anxiety Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)||||||
42546|NCT01425528|Primary|Change in Neurotransmitter Metabolite Levels in Cerebral Spinal Fluid||Baseline, 8 wks, 12 wks||||||
42547|NCT01425528|Primary|Change in BH4 Levels in Cerebral Spinal Fluid|Identify dosing range of oral Kuvan® necessary and sufficient to normalize CSF BH4 levels in adults with GTPCH Deficiency.|Baseline, 8 wks, 12 wks|Data from 4 of 6 participants was analyzed for Kuvan Cohort 1 and for Kuvan Cohort 2 for this outcome measure. 2 participant withdrew, 1 participant's diagnosis was reclassified and we were unable to obtain baseline CSF on 1 participant.||nmol/L||Standard Deviation|Mean
42548|NCT01425463|Secondary|Percentage of Responders at Week 12|Responders are defined as having an increment of Hemoglobin (Hb) > 15 g/L and post-treatment Hb > 120 g/L (male) or > 110 g/L (female) at Visit 6 (Week 12).|End of Treatment Period (Week 12)|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||percentage of participants|||Number
42549|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8||From Baseline to Week 8|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
42550|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4||From Baseline to Week 4|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
42551|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2||From Baseline to Week 2|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
42552|NCT01425463|Primary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12||From Baseline to Week 12|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.||gramm per liter (g/L)||Standard Deviation|Mean
42553|NCT01425359|Secondary|Patient's Global Impression of Change (PGIC) Scale Score|The PGIC was completed at the end of treatment/last visit.The PGIC scale measures the change in the participant's overall status since the beginning of the study on a scale ranging from 1 (no change or worse) to 7 (very much improved).|8 weeks|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Error|Mean
42569|NCT01424943|Primary|KIPS|KIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.|Baseline, 5 months|||scores on a scale||Standard Deviation|Mean
42554|NCT01425359|Secondary|Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. Participants were asked to complete the survey at randomization (prior to receiving treatment), and at end of treatment visit (Week 8) or early study drug discontinuation or early termination visit. The survey asked participants for responses specific to the preceding 4 weeks prior to completing the survey.|Up to 8 weeks|Participants in the Full Analysis Set with available data were analyzed.||units on a scale||Standard Error|Mean
42555|NCT01425359|Secondary|Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency||6 weeks|Full Analysis Set||percentage of weeks||Standard Error|Mean
42556|NCT01425359|Secondary|Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency|For each participant, the percentage of the last 6 weeks on treatment during which the angina frequency was less than or equal to 50% of the baseline average weekly angina frequency was determined.|6 weeks|Participants in the Full Analysis Set with available data were analyzed.||percentage of weeks||Standard Deviation|Mean
42557|NCT01425359|Secondary|Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment|Average weekly frequency of sublingual nitroglycerin use was defined as the total number reported during the last 6 weeks of treatment divided by the duration corresponding to the last 6 weeks of treatment.|6 weeks|Full Analysis Set||nitroglycerin uses per week||Standard Deviation|Mean
42558|NCT01425359|Primary|Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment|"Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks.~For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject’s actual duration of treatment."|6 weeks|Full Analysis Set (FAS): randomized participants who received at least 1 dose of randomized study drug with at least 1 postbaseline primary efficacy measurement and did not have any major eligibility violations. Participants were included in the FAS if they did not discontinue study drug prior to Day 14.||angina attacks per week||Standard Deviation|Mean
42559|NCT01425229|Primary|Cmax|Cmax after the first dose of bosentan, at steady-state, during clarithromycin|after first dose, at steady-state, during clarithromycin|||ng/ml||95% Confidence Interval|Geometric Mean
42560|NCT01425229|Primary|AUC|AUC of bosentan after first-dose, at steady-state and during clarithromycin therapy|0-infinity; dosing interval|||h*ng/ml||95% Confidence Interval|Geometric Mean
42561|NCT01425203|Secondary|Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8|EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.|Treatment Week 8|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. The Crossover arm had zero participants at TW8 since the first opportunity for participants in the PBO + PR Control arm to roll over to the Crossover arm was at TW12.||percentage of participants|||Number
42562|NCT01425203|Secondary|Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)|SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|mITT population included all randomized participants who received ≥1 dose of experimental trial drug: BOC (for Experimental RGT BOC + PR arm) or Placebo (for PBO + PR Control arm). Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.||percentage of participants|||Number
42563|NCT01425203|Primary|Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)|SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.||percentage of participants|||Number
42564|NCT01425190|Primary|Final Dose of Boceprevir By Age Group||Day 1|This outcome measure could not be analyzed due to termination of the study prior to enrolling Cohorts 2 and 3.|||||
42565|NCT01425190|Primary|Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir|The time at which the maximum plasma boceprevir concentration was observed.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.||Hour||Full Range|Mean
42566|NCT01425190|Primary|Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir|The maximum observed plasma concentration of boceprevir across sampling intervals was determined.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.||ng/mL||Full Range|Mean
42567|NCT01425190|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir|Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.||ng hr/mL||Full Range|Mean
42568|NCT01424943|Secondary|Parent Symptoms of Depression, Anxiety and Stress|DASS-21, brief screening measure of symptoms of depression, anxiety, and stress. Scores on each scale range from 0-21. Higher scores indicate more symptoms in each area.|baseline, 5 months|||scores on a scale||Standard Deviation|Mean
42583|NCT01424813|Other Pre-specified|Percent of Rescue Medication Free Days in the Patient Diary||Treatment days 1 through 85||||||
42570|NCT01424943|Primary|Parenting Self-confidence|Toddler Care Questionnaire. Measures parent reported self-confidence in parenting a toddler. Parents rate their confidence in performing parenting tasks specific to toddlers. Higher scores indicate more confidence. Scores range from 37-185. The total sum score derived from adding the scores for the 37 items in this survey was used for this outcome measure.|Baseline, 5 months|||units on a scale||Standard Deviation|Mean
42571|NCT01424943|Primary|Child Behavior|Child Behavior Checklist 1/5-5. A parent report measure of child behavioral problems. The score used for this outcome was the CBCL Total Score, which is a T-Score. T scores average 50 with a standard deviation of 10. Scores above 65 considered in the clinical range.|Baseline, 5 months|||T-score||Standard Deviation|Mean
42572|NCT01424943|Primary|Parenting Style|Parenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.|Baseline, 5 months|||scores on a scale||Standard Deviation|Mean
42573|NCT01424930|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.||ng*h/mL||Standard Deviation|Geometric Mean
42574|NCT01424930|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.||hours||Full Range|Median
42575|NCT01424930|Secondary|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.||ng/mL||Standard Deviation|Geometric Mean
42576|NCT01424930|Primary|Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication|AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.|Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1|Safety population: Participants who received at least 1 dose of study medication and contributed any safety data after the start of study treatment.||Participants|||Number
42577|NCT01424813|Other Pre-specified|Morning Peak Expiratory Flow Reading Reported on Patient Diary||Treatment days 1 through 85||||||
42578|NCT01424813|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).~Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:~Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Day 8, Day 85|Safety population||participants|||Number
42579|NCT01424813|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized. Two placebo participants were missing endpoint physical examinations.||participants|||Number
42580|NCT01424813|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 92|Safety analysis set||participants|||Number
42581|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
42582|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point||L*hr||95% Confidence Interval|Mean
42585|NCT01424813|Other Pre-specified|Duration of Response on Days 1, 8 and 85|Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes|Day 1, Day 8, Day 85||||||
42586|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85||||||
42587|NCT01424813|Other Pre-specified|Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85||||||
42588|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)||Day 1, Day 8, Day 85||||||
42589|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85||Day 85||||||
42590|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8||Day 8||||||
42591|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1||Day 1||||||
42592|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period||Day 1, Day 8, Day 85||||||
42593|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 85||||||
42594|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 8||||||
42595|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6||Day 1||||||
42596|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period||Day 1, Day 8, Day 85||||||
42597|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set||L*hr||95% Confidence Interval|Mean
42598|NCT01424813|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set which includes all participants in the intent-to-treat (ITT) population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.||L*hr||Standard Error|Mean
42599|NCT01424644|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|"The number of subjects reporting any unsolicited adverse reactions (AEs) when Tdap and HPV are concomitantly administered with MenACWY-CRM as compared to when Tdap and HPV vaccine are concomitantly administered with placebo.~Note: A total of 2 MenACWY-CRM+Tdap+HPV subjects reported AEs leading to premature withdrawal – one subject due to treatment emergent AE and another subject prior to study vaccination on day 1."|Throughout the study (Day 1 to Day 211).|Analysis was done on overall safety population - All subjects in the exposed population who provided postvaccination and post-baseline safety data.||Subjects|||Number
42600|NCT01424644|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine, Tdap and HPV vaccine as compared to concomitant administration of placebo with Tdap and HPV.|Day 1-7 after any vaccination.|Analysis was done on solicited safety Set - All subjects in the exposed population who provided solicited AEs.||Subjects|||Number
42601|NCT01424644|Secondary|Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.|The immunogenicity was assessed in terms of geometric mean hSBA titers of MenACWY when administered concomitantly with Tdap and HPV at 1 month after 1 dose of MenACWY vaccination.|1 month post MenACWY-CRM vaccination.|Analysis was done on the MenACWY per-protocol population - all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at baseline and one month postvaccination for at least one serogroup, and had no major protocol violation as defined prior to unblinding.||Titers||95% Confidence Interval|Geometric Mean
42602|NCT01424644|Primary|Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo|The geometric mean concentrations (GMCs) of antibodies against pertussis antigens (PT, FHA and PRN), as measured by ELISA, following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
42621|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42603|NCT01424644|Primary|Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo|The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population, i.e., all subjects who received all the relevant doses of vaccine correctly, and provided serology results at one month postvaccination, and had no major protocol violation as defined prior to unblinding.||percentages of subjects||95% Confidence Interval|Number
42604|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42605|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42606|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42607|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42608|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42609|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42610|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42611|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
43235|NCT01413191|Secondary|Durable Response Rate (i.e., the Proportion of Subjects With a Confirmed Complete or Partial Response ≥ 6 Months in Duration)|The durable response rate will be presented and the adjusted 95% confidence interval will be calculated.|Up to 2 years||||||
42612|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing 2 or More Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-17 (IL-17).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42613|NCT01424501|Secondary|Frequency of M72-specific CD8+ T Cells Per Million Cells Expressing at Least 2 Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42614|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42615|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42616|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42617|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42618|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42619|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42620|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
43234|NCT01413191|Secondary|Duration of Response|Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.|From the date criteria are first met for complete or partial response until the first date of documented progression, assessed up to 2 years||||||
42622|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing 2 or More Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-17 (IL-17).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42623|NCT01424501|Secondary|Frequency of M72-specific CD4+ T Cells Per Million Cells Expressing Any Combination of the Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Days 7 – D7 and 30 – D30), post-dose 2 (Days 37 – D37, 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||T cells/million cells||Inter-Quartile Range|Median
42624|NCT01424501|Secondary|Concentrations of Mycobacterium Tuberculosis Fusion Protein M72|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL).|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Day 30 – D30), post-dose 2 (Days 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||EU/mL||95% Confidence Interval|Geometric Mean
42625|NCT01424501|Secondary|Number of Subjects With Anti-mycobacterium Tuberculosis Fusion Protein M72 Antibodies|Cut-off values assessed were greater than or equal to 2.8, measured by ELISA (Enzyme Linked Immunosorbent Assay) in the sera of subjects seronegative before vaccination.|Prior to dose 1 (Day 0 - PRE), post-dose 1 (Day 30 – D30), post-dose 2 (Days 60 – D60 and 210 – D210)|The analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects who did not meet any of the criteria for elimination from ATP analysis,who complied with the procedures and intervals defined in the protocol and for whom data concerning immunogenicity endpoint measures were available at the time of each analysis.||Subjects|||Number
42626|NCT01424501|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to day 210|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
42627|NCT01424501|Primary|Number of Subjects With Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29), after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
42628|NCT01424501|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, malaise, myalgia and temperature [body temperature equal to or above 37.5 degrees Celsius (°C)]. The symptoms were assessed after each dose (Dose 1 = D1, Dose 2 = D2) and across doses.|During the 7 day (Days 0-6), after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
42629|NCT01424501|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. They were assessed after each dose (Dose 1 = D1, Dose 2 = D2) and across doses.|During the 7 day (Days 0-6), after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.||Subjects|||Number
42630|NCT01424228|Secondary|Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
42631|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
42648|NCT01424072|Primary|Coping Strategy: Distancing Domain|The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).|after 75 days|||units on a scale||Standard Deviation|Mean
42632|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
42633|NCT01424228|Secondary|Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks|Rescue medications include laxatives and enemas.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||days/week||Standard Deviation|Mean
42634|NCT01424228|Secondary|Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||tablets/week||Standard Deviation|Mean
42635|NCT01424228|Secondary|Time to First SCBM After Investigational Product Intake on Day 1 and Day 28||Day 1 and 28|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||hours||95% Confidence Interval|Median
42636|NCT01424228|Secondary|Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
42637|NCT01424228|Secondary|Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||percentage of SCBM||Standard Deviation|Mean
42638|NCT01424228|Secondary|Change From Baseline in Straining Per SCBM at Up to 24 Weeks|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
42639|NCT01424228|Secondary|Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||percentage of SCBM||Standard Deviation|Mean
42640|NCT01424228|Secondary|Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||units on a scale||Standard Deviation|Mean
42641|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
42642|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
42643|NCT01424228|Secondary|Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||SCBM/week||Standard Deviation|Mean
42644|NCT01424228|Secondary|Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.||SCBM/week||Standard Deviation|Mean
42645|NCT01424228|Secondary|Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
42646|NCT01424228|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. There were 21 subjects with a risk of potential unblinding due to an error in the randomization system who were excluded from the ITT Population to avoid the risk of bias to the study results.||percentage of subjects|||Number
42647|NCT01424072|Primary|Coping Strategy: Social Support Domain|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).||units on a scale||Standard Deviation|Mean
42649|NCT01424072|Primary|Coping Strategy: Domain Social Support(After 60 Days)|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).||units on a scale||Standard Deviation|Mean
42650|NCT01424072|Secondary|Stress Scale|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).||units on a scale||Standard Deviation|Mean
42651|NCT01424033|Primary|Pulmonary Function Tests||Every 3 months||||||
42652|NCT01423916|Secondary|Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.|Changes in HR with values 25% decrease from Day −1 and HR < 50 bpm and 25% increase from Day −1 and HR > 100 bpm; PR interval of greater than or equal to 25% change from Day −1 and PR > 200 msec; QRS interval of Greater than or equal to 25% change from Day −1 and > 100 msec were noted on Day 11. Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate.|Day 11|Electrocardiograms were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.||participants|||Number
42653|NCT01423916|Secondary|Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.|Participants with incidence of ECG morphology abnormalities on Day 11 (participants who had abnormalities during Day 11 but not at Day -1) were noted. Types of abnormalities included appearance of abnormal U waves, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, and left bundle branch block. ECGs were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.|Day 11|Number of participants who took at least one dose of study drug post Day −1, and had evaluations of the ECG parameters at Baseline and Post Baseline.||participants|||Number
42654|NCT01423916|Secondary|Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.|The number of participants who were noted with new incidence of QT interval of > 500 msec on Day 11 and a 12-lead ECG was used.|Day 11|Assay sensitivity sample dataset demonstrated the ability of the trial that detected the effect of moxifloxacin on the QTcI that consisted from randomized participants in moxifloxacin and placebo arms, who had evaluable time-matched ECG assessments in both periods (Day -1/1 or Day 11/12) in placebo and moxifloxacin on Days -1, 1, 11, and 12.||participants|||Number
42655|NCT01423916|Secondary|Number of Participants With QTcI Interval > 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change of > 60 msec on Day 11 were presented here.|Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.||participants|||Number
42656|NCT01423916|Secondary|Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change between 30 to 60 msec were presented here.|Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.||participants|||Number
42657|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change from Baseline in summary of maximum QTcI on Day 11 minus maximum QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.||msec||Standard Deviation|Mean
42658|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change form Baseline in summary of maximun QTcI on Day 11 minus mean QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.||msec||Standard Deviation|Mean
42659|NCT01423916|Secondary|Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.|New onset (> 450, > 480, or > 500 msec) in QTc was defined as a participant who attained a QTc > 450, > 480, > 500 msec during Day 11 but not on Day −1. The number of participants were noted with time-matched change in mean QTcI change from Baseline for assay sensitivity of moxifloxacin treatment corrected for placebo. The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.||participants|||Number
42660|NCT01423916|Primary|Area Under the Plasma Concentration-time Curve During Dosing (AUCT).|Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations. For Moxifloxacin group, area under the plasma concentration-time curve was calculated to the last observable concentration.||ng*h/mL||Standard Deviation|Mean
42661|NCT01423916|Primary|Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.||Hours||Full Range|Median
42662|NCT01423916|Primary|Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|Pharmacokinetics (PK) analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.||ng/mL||Standard Deviation|Mean
42663|NCT01423916|Primary|Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).|Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.|AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication|Safety dataset of randomized participants received 1 dose of study medication after Day 1.||participants|||Number
42664|NCT01423916|Primary|Time-matched QTcI Change From Baseline (Day −1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.|Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)|The dataset quantitates effect of brexpiprazole on individual QTcI corrected for placebo of the completer population where participants received study medication from Day 1 to Day 11 (placebo at Day 1) had 1 Predose and Post-dose time-matched ECG assessments on Day 1 and Day 11. The first 5 time points for moxifloxacin arm only were 2-sided 98% CI.||msec||90% Confidence Interval|Mean
42665|NCT01423773|Primary|Final Comfort|"Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable (My eyes are in pain. I cannot tolerate my lenses) and 100=Extremely Comfortable (My eyes feel GREAT, better than normal. I cannot feel my lenses)."|Day 2, Hour 10|All enrolled participants||Units on a scale||Standard Deviation|Mean
42666|NCT01423760|Secondary|Overall Survival (OS)|Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.|From randomization to death, assessed up to 3.6 years|Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)|||||
42667|NCT01423760|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death|An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.|Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years|Only subjects treated with tecemotide were included in the safety analysis set.||Subjects|||Number
42668|NCT01423617|Secondary|Global Evaluation of Efficacy by Subjects|"The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of very good, good, moderate and poor."|12 weeks||||||
42669|NCT01423617|Secondary|Global Evaluation of Safety by Subjects|"The subjects evaluate independently the safety of the investigational product, using a scale with scores of “very good”, “good”, “moderate” and “poor."|12 weeks||||||
42670|NCT01423617|Secondary|Global Evaluation of Safety by Investigators|"The investigators evaluate independently the safety of the investigational product, using a scale with scores of “very good”, “good”, “moderate” and “poor."|12 weeks||||||
42671|NCT01423617|Secondary|Changes in Body Fat Free Mass (kg)||12 weeks||||||
42681|NCT01423604|Secondary|Summary of Clinical Benefit|"A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:~Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status~Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation."|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||percentage of participants|||Number
42682|NCT01423604|Secondary|Durable Response Rate|Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||percentage of participants|||Number
42683|NCT01423604|Secondary|Objective Response Rate|Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Measured every 4 weeks for duration of study treatment (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||percentage of participants|||Number
42684|NCT01423604|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||days||95% Confidence Interval|Median
42685|NCT01423604|Primary|Overall Survival|Overall survival was measured as the length of time (in days) between the randomization date and the date of death.|Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.||days||95% Confidence Interval|Median
42686|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to week 12|Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
42687|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score|The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to week 12|Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
42688|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score|The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to week 12|Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
42689|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in CGI-S Score|The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|baseline to week 12|Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)||units on a scale||Standard Deviation|Mean
42690|NCT01423253|Primary|Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)|12 Weeks|Safety Population||percentage of subjects|||Number
42691|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)|Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)|12 Weeks|Safety Population||percentage of subjects|||Number
42692|NCT01423253|Secondary|Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores|Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject’s level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to12 Weeks|Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).||units on a scale||Standard Deviation|Mean
42693|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects with treatment emergent adverse events (TEAEs)|12 Weeks|Safety population||percentage of subjects|||Number
42694|NCT01423162|Primary|Percent Iron Absorption|Percentage of iron available for absorption from fortified oat drink with and without added vitamin C|14 days after administration|Per protocol||percentage of Iron absorbed||Standard Error|Mean
42698|NCT01423084|Secondary|GMR of ELISA GMCs Against Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset||Ratio of GMTs||95% Confidence Interval|Geometric Mean
42699|NCT01423084|Primary|ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|One month after the second vaccination (day 61)|Per Protocol Set population||IU/ml||95% Confidence Interval|Geometric Mean
42700|NCT01423084|Secondary|ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset.||IU/ml||95% Confidence Interval|Geometric Mean
42701|NCT01423084|Secondary|Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.|The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Population, immunogenicity subset||Percentage of subjects||95% Confidence Interval|Number
42702|NCT01423084|Secondary|GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|"The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N.~meningitidis serogroup B reference strains at two weeks after last vaccination."|Two weeks after the second vaccination (day 45)|Per Protocol Set, Immunogenicity subset||Ratio of GMTs||95% Confidence Interval|Geometric Mean
42703|NCT01423084|Secondary|hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset||Titers||95% Confidence Interval|Geometric Mean
42704|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population||Ratio of GMTs||95% Confidence Interval|Geometric Mean
42705|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.|The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population||Ratio of GMTs||95% Confidence Interval|Geometric Mean
42706|NCT01423084|Secondary|Percentage of Subjects in Each Lot With hSBA ≥ 1:5|The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group|One month after the second vaccination (day 61)|Per Protocol Set population||Percentage of subjects||95% Confidence Interval|Number
42707|NCT01423084|Primary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.|Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).|One month after the second vaccination (day 61)|Per Protocol Set population||Titers||95% Confidence Interval|Geometric Mean
42708|NCT01422889|Secondary|Stent Thrombosis|Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|Annually, after the first year, through 2 years.|There were 57 subjects not evaluable for 2-year cardiac events (No follow-up ≥ 700 days and events-free within 730-day) leaving a total of 1054 subjects evaluated for ARC ST Definite/Probable.||percentage of participants|||Number
42709|NCT01422889|Primary|Cardiac Death or Myocardial Infarction (CD/MI)|Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|12 Months|There were 83 subjects not evaluable for 12-month cardiac events (No follow-up ≥ 335 days and events-free within 365-day) leaving a total of 1028 subjects evaluated for 12 month CD/MI.||percentage of paricipants|||Number
42710|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients|Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS-treatment naive patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
42711|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Metformin Background Patients|Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS- Metformin background patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
42712|NCT01422876|Secondary|Change From Baseline in Body Weight for Treatment Naive Patients|Change from baseline in body weight for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||kg change from baseline||Standard Error|Least Squares Mean
42713|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised to and treated who had a baseline and at least 1 on treatment HbA1c value.||% change from baseline||Standard Error|Least Squares Mean
42714|NCT01422876|Secondary|Change From Baseline in Body Weight for Metformin Background Patients|Change from baseline in body weight for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||kg change from baseline||Standard Error|Least Squares Mean
42715|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients|Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||mg/dL change from baseline||Standard Error|Least Squares Mean
42716|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients|Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||mg/dL change from baseline||Standard Error|Least Squares Mean
42717|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.||% change from baseline||Standard Error|Least Squares Mean
42718|NCT01422850|Primary|Blood Pressure, Pulse and Temperature|Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25|||participants|||Number
42719|NCT01422850|Secondary|The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed.|No significant conclusion of efficacy is possible due to the study design with only one group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy, defined as stable disease or partial response, are possible. Trends towards possible treatment response were measured by monitoring PSA, a potential marker for prostate cancer disease progression; by other blood markers; and by Quality of life questionnaire (EORTC QLQ-C30) and WHO/ECOG (Eastern Cooperative Oncology Group). Control of any bone metastases were followed by hotspots and bone scan index measured by skeletal scintigraphy.|Within 12 weeks|||participants|||Number
42720|NCT01422850|Primary|Adverse Events|"To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes).~AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not."|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25|No formal statistical analysis plan was considered for this study. Any subject that received one administration of ALECSAT and a 6 week follow-up period will be considered as having received ALECSAT and be included in the efficacy part of the report. All patients that received at least one injection of ALECSAT was assessed for safety.||Events|||Number
42721|NCT01422824|Secondary|Hemoglobin Levels||Baseline; Weeks 8, 16, 24, 48|Efficacy intent-to-treat population included all treated participants. Here, 'n' signifies the number of participants with available data for hemoglobin at specified visits.||gram per liter||Standard Deviation|Mean
42722|NCT01422824|Primary|Number of Participants With Adverse Events (AEs)|AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.|Up to 12 months|Safety population||participants|||Number
42723|NCT01422720|Secondary|Change From Baseline in Standardized Seizure Frequency|Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.|8-week Baseline Period and 26-week Treatment Period|||seizures/4 weeks||Standard Deviation|Mean
42724|NCT01422720|Primary|Number of Subjects With Reported Adverse Events (AE)|"An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP.~TEAE assessment:~patients who died~patients who died due to Treatment-emergent adverse event (TEAE)~patients with at least one Serious Adverse Event (SAE)~patients with at least one Treatment-emergent Serious Adverse Event (TESAE)~patients prematurely terminated due to TEAE~patients with at least one TEAE~patients with at least one related TEAE~patients with at least one severe TEAE~patients with at least one severe TEAE"|throughout the study|||participants|||Number
42889|NCT01420081|Secondary|Pharmacokinetic Parameters of PF-04691502 and PF-05212384 at Each Specified Time Points|Pharmacokinetic parameters were to be evaluated at each specified time points. This outcome measure will be updated once the data is available with the supplemental clinical study report.|0, 0.5, 1, 2, 4, 6, 24, 72, and 120 hours post dose and pre and 0.5 hour post dose cycles 2, 3, 4||12/2016||||
42725|NCT01422538|Secondary|Subject Satisfaction at 180 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.||percentage of participants Satisfied|||Number
42726|NCT01422538|Secondary|Subject Satisfaction at 90 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.|90 days post-treatment.|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied or Satisfied.||percentage of participants Satisfied|||Number
42727|NCT01422538|Other Pre-specified|Subject's Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only.|During Ulthera study treatment|||units on a scale||Full Range|Mean
42728|NCT01422538|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment|||percentage of participants improved|||Number
42729|NCT01422538|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment.|||percentage of participants improved|||Number
42730|NCT01422538|Primary|Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.|Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.|90 days post-treatment|||percentage of participants improved|||Number
42731|NCT01422434|Secondary|Change in mPASI From Baseline to Week 1|The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8|Baseline to Week 1|||percentage of change||Standard Deviation|Mean
42732|NCT01422434|Secondary|Physician's Global Assessment of Psoriasis|"Subjects with ‘clear’ or ‘almost clear’ disease by physician’s global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.~The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Week 4|||participants|||Number
42733|NCT01422434|Secondary|Change From Baseline in Target Lesion Assessment|"Percentage change in composite severity score of the target lesion from baseline to Week 4.~At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.~At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.~The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated."|Baseline to Week 4|||percentage of change||Standard Deviation|Mean
42734|NCT01422434|Primary|Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)|"The primary response criterion was the percentage change in m-PASI from baseline to Week 4.~The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:~Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8."|Baseline to Week 4|||percentage of change||Standard Deviation|Mean
42735|NCT01422382|Secondary|Number of Participants With at Least One Adverse Event.||24 Days|||Participants|||Number
42736|NCT01422382|Primary|NK-104 AUC||15 Days|All subjects with measurable pharmacokinetic (PK) values||ng * h/mL||Standard Deviation|Mean
42737|NCT01422369|Secondary|Number of Participants With at Least One Adverse Event.||16 Days|All subjects who took at least one dose of study medication.||Participants|||Number
42738|NCT01422369|Primary|NK-104 AUC||16 Days|All subjects with measurable pharmacokinetic (PK) values.||ng * h/mL||Standard Deviation|Mean
42739|NCT01422356|Primary|HPV Prevalence|Prevalence of anal HPV of any type at baseline|Baseline|Number of men at baseline visit||participants|||Number
42740|NCT01422304|Other Pre-specified|Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration|This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased.|Up to 72 hours post study drug administration|APaT population||participants|||Number
42741|NCT01422304|Other Pre-specified|Postoperative Changes in Hgb Concentrations Using the Bleeding Index|The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 – Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline.|Baseline and Visit 3 (24-48 hours post study drug administration)|APaT population||g/L||Standard Deviation|Mean
42742|NCT01422304|Other Pre-specified|Total Transfusion Volume in Participants Who Required Postoperative Transfusion|Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to “normal” volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume.|From end of study drug administration through approximately 120 hours after study drug administration|Participants in APaT population who received a transfusion unit that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion)||mL||Geometric Coefficient of Variation|Geometric Mean
42743|NCT01422304|Other Pre-specified|Number of Participants Requiring Any Postoperative Transfusion|The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion) was determined.|From end of study drug administration through approximately 120 hours after study drug administration|APaT population||participants|||Number
42744|NCT01422304|Other Pre-specified|Postoperative Drainage Volume Within 24 Hours After Study Drug Administration|The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.|Up to 24 hours post study drug administration|APaT population||mL||Standard Deviation|Mean
42745|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms.|Up to 14 days post study drug administration|APaT population||participants|||Number
42746|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis).|Up to 14 days post study drug administration|APaT population||participants|||Number
42747|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 14 days post study drug administration|APaT population||participants|||Number
42748|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 24 hours post study drug administration|APaT population||participants|||Number
42772|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Acquisition)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS||number of words correctly recalled||Standard Error|Mean
42749|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration|"This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 14 days post study drug administration|APaT population||participants|||Number
42750|NCT01422304|Secondary|Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = [PT-Test/PT-Normal]^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline PT(INR) measurement within defined assessment window (10 or 60 minutes post study drug).||percent change||Standard Deviation|Mean
42751|NCT01422304|Secondary|Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline aPTT measurement within defined assessment window (10 or 60 minutes post study drug).||percent change||Standard Deviation|Mean
42752|NCT01422304|Primary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration|"Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 24 hours post study drug administration|APaT population||participants|||Number
42753|NCT01422239|Secondary|Change in Smoking From Baseline to the Followup Assessment (Week 12)|Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study.|Week 0 (baseline), Week 12 (one month followup)|Participants who completed the week 8 appointment and provided the number of cigarettes smoked per day were included.||CPD||Standard Deviation|Mean
42754|NCT01422239|Secondary|Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|12 weeks|participants who did not complete the appointment were considered to be smoking||participants|||Number
42755|NCT01422239|Primary|Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|Up to 8 weeks|Participants who dropped out of the study were considered to be smoking.||participants|||Number
42756|NCT01422226|Primary|Ease of IUD Insertion (Use of Ancillary Measures)|The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.|During the IUD insertion procedure, up to 2 hours|||participants|||Number
42757|NCT01422213|Secondary|Risk of Suicidality Using C-SSRS Scores|"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient.~For 2 patients in each treament group (6 in total) the CSSRS assessments are missing during study."|Up to 8 weeks|APTS||participants|||Number
42773|NCT01422213|Secondary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols)|"Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning). as a description of DSST."|Baseline and Week 8|FAS||number of correct symbols||Standard Error|Mean
42758|NCT01422213|Secondary|Change From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables."|Baseline and Week 8|FAS, LOCF||z score||Standard Error|Least Squares Mean
42759|NCT01422213|Secondary|Change From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables.~In the week 1 analysis the vortioxetine 10 and 20 mg groups were pooled because patients randomized to vortioxetine 20 mg received vortioxetine 10 mg in the first week of the study."|Baseline and Week 1|FAS, LOCF||z score||Standard Error|Least Squares Mean
42760|NCT01422213|Secondary|Proportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF||percentage of participants|||Number
42761|NCT01422213|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline||Baseline and Week 8|FAS, last observation carried forward (LOCF)||percentage of participants|||Number
42762|NCT01422213|Secondary|Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS||units on a scale||Standard Error|Mean
42763|NCT01422213|Secondary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
42764|NCT01422213|Secondary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS||units on a scale||Standard Error|Mean
42765|NCT01422213|Secondary|Change From Baseline to Week 8 in the CRT (Attention)||Baseline and Week 8|FAS||log10 (ms)||Standard Error|Mean
42766|NCT01422213|Secondary|Change From Baseline to Week 8 in the SRT (Speed of Processing)|"Simple Reaction Time (SRT) is designed to assess psychomotor speed, and Choice Reaction Time (CRT) is designed to assess visual attention. Two computerised tests, part of the CogState battery were used to measure SRT and CRT in milliseconds:~The detection task measures SRT: the patient presses a yes button, whenever an onscreen playing card is turned over.~The identification task measures CRT: the patient presses a yes button whenever an onscreen playing card is turned over and is red, or a no button if the card is not red."|Baseline and Week 8|FAS||log10 (ms)||Standard Error|Mean
42767|NCT01422213|Secondary|Change From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)||Baseline and Week 8|FAS||seconds||Standard Error|Mean
42768|NCT01422213|Secondary|Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)|Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline and Week 8|FAS||seconds||Standard Error|Mean
42769|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT B (Executive Function)|TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline and Week 8|FAS||seconds||Standard Error|Mean
42770|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT A (Speed of Processing)|Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline and Week 8|FAS||seconds||Standard Error|Mean
42771|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Delayed Recall)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS||number of words correctly recalled||Standard Error|Mean
49783|NCT01324687|Primary|Emergency Department Use|Use of emergency department by individuals with access to care via telemedicine as compared to those without such access to care.|Up to 42 months|||Emergency dept use rate per person-month|||Number
42774|NCT01422213|Primary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores|"DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).~RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.~The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25."|Baseline and Week 8|FAS||z score||Standard Error|Mean
42775|NCT01422187|Secondary|Hemoglobin|Hemoglobin measure yearly|60 months|||mg/dL||Standard Error|Mean
42776|NCT01422187|Secondary|Platelet Count|Platelet count measure annually|60 months|||platelets/mm^3||Standard Error|Mean
42777|NCT01422187|Secondary|Liver Volume|Liver volume by MRI|60 months|||Milliliters||Standard Error|Mean
42778|NCT01422187|Primary|Spleen Volume|Spleen volume measured by MRI|60 months|||Milliliters||Standard Error|Mean
42779|NCT01422070|Secondary|Number of ICU Readmissions|Number of readmissions to intensive care unit during the same hospital course|Max 90 days after admission to the Study Unit|||readmissions|||Number
42780|NCT01422070|Secondary|Length of Hospital Stay|Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital|Max 90 days after admission to the Study Unit|||days||Inter-Quartile Range|Median
42781|NCT01422070|Secondary|Length of ICU Stay|Number of days (calendar days -1) from admission to and discharge from the Study Unit|Max 90 days after admission to intensive care unit|||days||Inter-Quartile Range|Median
42782|NCT01422070|Primary|Vital Status at Hospital Discharge|Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital|Max 90 days after admission to the Study Unit|||participants|||Number
42783|NCT01421667|Secondary|Baseline Soluble CD30 Expression|Serum concentration of soluble CD30 before first dose of brentuximab vedotin|Baseline|All patients who were treated with brentuximab vedotin monotherapy and had baseline sCD30 expression results.||ng/mL||Full Range|Median
42784|NCT01421667|Secondary|Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)|Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Tmax of MMAE results.||days||Full Range|Median
42785|NCT01421667|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)|Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Cmax of MMAE results.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
42786|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)|Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Ctrough of ADC results.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
42787|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)|End of infusion concentration of ADC following the first dose of brentuximab vedotin|1 day|All patients who were treated with brentuximab vedotin monotherapy and had Ceoi of ADC results.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
42788|NCT01421667|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy.||participants|||Number
42789|NCT01421667|Secondary|Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
42790|NCT01421667|Secondary|Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.||months||Full Range|Median
42791|NCT01421667|Secondary|Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved CR||months||Full Range|Median
42792|NCT01421667|Secondary|Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved a CR or PR.||months||Full Range|Median
42793|NCT01421667|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
42794|NCT01421667|Secondary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab|Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
42795|NCT01421667|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin plus rituximab.||participants|||Number
42796|NCT01421667|Primary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
42797|NCT01421654|Primary|Hours Used|The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.|30 days|||Total Hours Used||Standard Deviation|Mean
42798|NCT01421641|Secondary|Tenaculum Placement Satisfaction|Satisfaction with overall tenaculum placement procedure. Subjects asked to answer their overall satisfaction with the pain control. Subjects asked to complete 100mm Visual Analog Scale (0mm=not at all satisfied to 100mm=very satisfied)|After placement of the tenaculum|||mm||Standard Deviation|Mean
42799|NCT01421641|Secondary|Intervention Pain|Pain with the intervention (injection or gel application). Subjects are asked to complete pain scale using a 100mm Visual Analog Scale (0mm=no pain and 100mm=worst pain of my life)|after application of randomized intervention|||mm||Standard Deviation|Mean
42800|NCT01421641|Primary|Tenaculum Pain|The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.|After tenaculum placement|4 subjects were excluded due to protocol violations||mm||Standard Deviation|Mean
42801|NCT01421589|Secondary|Change in Phosphocreatine Recovery|Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Obese men with reduced GH secretion were treated with rhGH for 12 weeks. All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties.||mM/min||Standard Error|Mean
42802|NCT01421589|Secondary|Change in Insulin Sensitivity|Change in fasting glucose from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||mg/dl||Standard Error|Mean
42803|NCT01421589|Secondary|Change in Inflammatory Marker|Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||mg/l||Standard Error|Mean
42804|NCT01421589|Secondary|Change in Body Composition|Change in waist circumference from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||cm||Standard Error|Mean
42805|NCT01421589|Secondary|Change in Skeletal Muscle IGF-1 Gene Expression|Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Paired analyses (both Baseline and 12-weeks) from only 10 subjects are available for gene expression||fold change||Standard Error|Mean
42806|NCT01421589|Secondary|Change in Circulating IGF-1 Concentration|Change in circulating IGF-1 from Baseline to 12-weeks is reported.|Baseline and 12-weeks|||ug/l||Standard Error|Mean
42807|NCT01421589|Primary|Phosphocreatine Recovery|The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.|12-weeks|All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties. In addition, paired analyses (both Baseline and 12-weeks) from only 10 subjects were available for gene expression analyses. Therefore univariate regression analyses between IGF-1 mRNA and PCr recovery could only be performed in 10 subjects.||correlation coefficient|||Number
42808|NCT01421511|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.||units on a scale||Standard Deviation|Mean
42809|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the Day-7 Visit|Clinical improvement defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
42810|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement defined as improvement in overall clinical status.|48-72 Hours|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
42811|NCT01421511|Secondary|Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized participants receiving minimal study therapy, completed EOT and PTE Investigator's assessments, no concomitant systemic antibiotic therapy through PTE, and no confounding events or factors.||participants|||Number
42812|NCT01421511|Secondary|Investigator’s Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
42813|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set|Responder: No increase in lesion surface area from baseline.|End of Therapy Day 11|All randomized participants receiving minimal study therapy, completed EOT assessment, no concomitant systemic antibiotic therapy and no confounding events or factors.||participants|||Number
42814|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit|Responder: No increase in lesion surface area from baseline.|Day 11|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
42815|NCT01421511|Primary|The Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline.|48-72 hours|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
42816|NCT01421472|Primary|Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)|Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.|At time of surgery, an expected average of 24-26 weeks|Subjects with evaluable resection.||participants|||Number
42817|NCT01421459|Other Pre-specified|Percentage of Participants With Treatment Emergent Antibody Response (TEAR)|TEAR is defined as an absolute increase of at least 1% in insulin antibody levels (measured in % binding) and at least 30% relative increase from Baseline for participants who are insulin antibody-positive at Baseline, or turning from insulin antibody-negative status at Baseline to antibody-positive during the course of the study following treatment with study drug.|4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).||percentage of participants|||Number
42818|NCT01421459|Other Pre-specified|Percentage of Participants With Detectable Insulin Antibody Levels||Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).||percentage of participants|||Number
42819|NCT01421459|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event.||hypoglycemic events per 30 days||Standard Deviation|Mean
42820|NCT01421459|Secondary|Incidence of Hypoglycemic Events|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline hypoglycemic event measure.||hypoglycemic events in 24 weeks|||Number
42821|NCT01421459|Secondary|Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).||percentage of participants|||Number
43037|NCT01416610|Secondary|Percentage of Participants With SVR 12|SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|12 weeks after completing treatment, within 3 years, 6 months|||percentage of participants||95% Confidence Interval|Number
42822|NCT01421459|Secondary|Insulin Dose (Units)|Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline insulin dose measure; last observation carried forward (LOCF).||units per day (U/day)||Standard Error|Least Squares Mean
42823|NCT01421459|Secondary|Insulin Dose Per Body Weight (U/kg) Per Day|Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Insulin Dose per Body Weight measure; last observation carried forward (LOCF).||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
42824|NCT01421459|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure; last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
42825|NCT01421459|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on “Behavior” items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment."|4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ALBSS measure; last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
42826|NCT01421459|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure; last observation carried forward (LOCF).||kilogram (kg)||Standard Error|Least Squares Mean
42827|NCT01421459|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure; last observation carried forward (LOCF).||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
42828|NCT01421459|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint [up to 24 weeks (wk)]|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure; last observation carried forward (LOCF).||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
42829|NCT01421459|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure.||percentage of HbA1c||Standard Error|Least Squares Mean
42830|NCT01421459|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.|Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline insulin antibody measure; last observation carried forward (LOCF).||percentage of insulin antibody binding||Standard Error|Least Squares Mean
42944|NCT01419197|Secondary|6-month and 1-year Survival|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
42831|NCT01421459|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
42832|NCT01421355|Primary|Change in Brachial Artery Diameter|The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.|Day 0 and Day 4|||percentage of dilation||Standard Deviation|Mean
42833|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between change from baseline in WPAI-AS and EQ-5D VAS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
42834|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between WPAI-AS and EQ-5D VAS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42835|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between change from baseline in WPAI-AS and EQ-5D total score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
42836|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between WPAI-AS and EQ-5D total score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42862|NCT01421147|Secondary|Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])|Total daily insulin dose was adjusted for body weight [units of insulin/kilogram/day (U/kg/day)]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 daily insulin dose per body weight measurements. Last observation carried forward (LOCF) principle was used.||U/kg/day||Standard Error|Least Squares Mean
42837|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10(norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and MCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
42838|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline|WPAI-AS: 6-item questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). Sub-scores transformed to impairment percentages (range 0 to 100), higher numbers=greater impairment,less productivity. SF-36:standardized survey evaluating 8 aspects of functional health, well being (physical, social functioning; physical, emotional role limitations; bodily pain; general health; vitality; mental health). 8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50, standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and MCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42839|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity),activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100),higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and PCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
42840|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and mental component summary (MCS).Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and PCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42841|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between change from baseline in WPAI-AS and BAS-G score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
42842|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between WPAI-AS and BAS-G score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42843|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between change from baseline in WPAI-AS and BASMI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
42844|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between WPAI-AS and BASMI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42845|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between change from baseline in WPAI-AS and BASFI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at visit 1 (baseline), started the treatment with etanercept and had at least one visit during follow-up. Here 'n' signifies those participants who were evaluable at specified time points for the given sub-scale items.||Correlation coefficient|||Number
42846|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between WPAI-AS and BASFI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42871|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)||Baseline to Week 6|Intent to treat population||percentage of subjects|||Number
42847|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between change from baseline in WPAI-AS and BASDAI score at Month 6 and 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Correlation coefficient|||Number
42848|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between WPAI-AS and BASDAI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.||Correlation coefficient|||Number
42849|NCT01421303|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24|WPAI: AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis (AS) for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.||Percentage of impairment||Standard Deviation|Mean
42850|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 24.||Percentage of impairment||Standard Deviation|Mean
42851|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 18|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 18.||Percentage of impairment||Standard Deviation|Mean
42852|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 12|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 12.||Percentage of impairment||Standard Deviation|Mean
51648|NCT01301079|Primary|Pain 120 Minutes|The scale measure pain after 120 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|120 minutes|||units on a scale||Standard Deviation|Mean
42853|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 6|Follow-up analysis set (FAS) consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 6.||Percentage of impairment||Standard Deviation|Mean
42854|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline|Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given sub-scale items at baseline.||Percentage of impairment||Standard Deviation|Mean
42855|NCT01421277|Primary|Main Reason for Stopping Triptan Use||Up to 3 months|All screened participants who were fully eligible for the study.||Number of partiicpants|||Number
42856|NCT01421277|Primary|Number of Participants Continuing Triptan Therapy|Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.|Up to 3 monoths|All screened participants who were fully eligible for the study.||Number of participants|||Number
42857|NCT01421277|Primary|Number of Participants Using a Triptan for Migraine Attacks|Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.|Up to 3 months|All screened participants who were fully eligible for the study.||Number of participants|||Number
42858|NCT01421147|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.||hypoglycemic events per 30 days||Standard Deviation|Mean
42859|NCT01421147|Secondary|Incidence of Hypoglycemic Events|Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.||events|||Number
42860|NCT01421147|Secondary|Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).||percentage of participants|||Number
42861|NCT01421147|Secondary|Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])|Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 insulin daily dose measurements. Last observation carried forward (LOCF) principle was used.||units of insulin per day (U/day)||Standard Error|Least Squares Mean
42872|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).||Baseline to Week 6|Intent to treat population||percentage of subjects|||Number
51649|NCT01301079|Primary|Pain 90 Minutes|The scale measure pain after 90 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|90 minutes|||units on a scale||Standard Deviation|Mean
42863|NCT01421147|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen [(IR) 5 items: scores range 5-35], Lifestyle Flexibility [(LF) 3 items: scores range 3-21], Glycemic Control [(GC) 3 items: scores range 3-21], Hypoglycemic Control [(HC) 5 items: scores range 5-35], Insulin Delivery Device [(IDD) 6 items: scores range 6-42]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×[(7-raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ITSQ measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).||units on a scale||Standard Error|Least Squares Mean
42864|NCT01421147|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on Behavior items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country."|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ALBSS measurement. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).||units on a scale||Standard Error|Least Squares Mean
42865|NCT01421147|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline body weight measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).||kilogram (kg)||Standard Error|Least Squares Mean
42866|NCT01421147|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints (up to 24 weeks and up 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline fasting blood glucose measurement. Last observation carried forward (LOCF) principle was used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
42867|NCT01421147|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline SMBG measurement. Last observation carried forward (LOCF) principle was used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
42868|NCT01421147|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline HbA1c measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
42869|NCT01421147|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and were insulin antibody positive at baseline and had at least 1 post-baseline insulin antibody positive measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 and up to 52 weeks).||percentage of insulin antibody binding||Standard Error|Least Squares Mean
42870|NCT01421147|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
42873|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score|The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to Week 6|Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment.||units on a scale||Standard Error|Least Squares Mean
42874|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to Week 6|Intent to treat population: If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.||units on a scale||Standard Error|Least Squares Mean
42875|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to Week 6|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
42876|NCT01421134|Secondary|Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Baseline to Week 6|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
42877|NCT01421134|Primary|Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to Week 6|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
42878|NCT01420926|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|Duration of treatment||||||
42879|NCT01420926|Secondary|Progression-free Survival|Progression free survival (PFS) was defined as the time from study entry to progression or death. Progression free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to progression and/or death (up to 10 years)||||||
42880|NCT01420926|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) was defined as the time from CR to relapse or death. Relapse free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method. Relapse is defined as the reappearance of blood blasts or >= 5% marrow blasts after achieving a CR or CRi.|Time from study entry to relapse and/or death (up to 10 years)||||||
42881|NCT01420926|Secondary|Complete Remission Rate (CR and CRi)|Defined as the number of patients who achieve a CR or CRi divided by the total number of evaluable patients. A Complete remission (CR) requires: <5% marrow blast, > 200 nucleated cells, no blasts with auer rods, no extramedullary disease, ANC >1,000/mm^3 and platelets > 100,000/mm^3. A CR with incomplete blood count recovery (CRi) is defined as CR with exception of ANC < 1,000/mm^3 or platelets < 100,000/mm^3.|Duration of study up to 10 years||||||
42882|NCT01420926|Primary|Overall Survival (OS) Time|Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to death assessed up to 10 years|||months||95% Confidence Interval|Median
42883|NCT01420848|Secondary|Students Anxiety Levels|The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.|90 days|It was analysed only the number of participants that ended the study.||units on a scale||Standard Deviation|Mean
42884|NCT01420848|Primary|Students Stress Levels|The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.|90 days|It was analysed only the subjects that ended the study.||units on a scale||Standard Deviation|Mean
42885|NCT01420289|Secondary|Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.|Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks|16 weeks|||Percent improvement in mean VAS pain sco||Standard Error|Mean
42886|NCT01420289|Secondary|Perceived Improvement in Physical Function After 16 Weeks|"Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16.~The higher the score on the SF-36 questionnaire the better the QOL."|16 weeks|||Percent improvement in Sf-36 QOL score||Standard Error|Mean
42890|NCT01420081|Secondary|Percentage of Participants in Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue|Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, and PIK3CA gene amplification were to be assessed. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline, Post-baseline||12/2016||||
42891|NCT01420081|Secondary|Percentage of Participants in Each Treatment Arm With Expression and/or Phosphorylation in PI3K Pathway Proteins in Biopsied Tumor Tissue|Expression and/or phosphorylation in biopsied tumor tissue of PI3K pathway proteins such as p-AKT, p-S6, p-S6K, p-mTOR, p-PRAS40, stathmin were to be assessed. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline, Post-baseline||12/2016||||
42892|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline, Post-baseline||12/2016||||
42893|NCT01420081|Secondary|Overall Survival (OS) for PF-05212384|OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.|12 months|Survival analysis was not performed as the study was terminated early. No data are available because data were not collected. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||||
42894|NCT01420081|Secondary|Progression Free Survival for PF-04691502|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Time to Event (Days)|||Number
42895|NCT01420081|Secondary|Progression Free Survival for PF-05212384|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Days||95% Confidence Interval|Median
42896|NCT01420081|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384|Progression free survival is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the probability of remaining progression-free at 6 months (based on Kaplan-Meier estimates). Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|6 months|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Percentage of participants||95% Confidence Interval|Number
42897|NCT01420081|Secondary|Objective Response for PF-04691502|"Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions. The outcome data table below presents the number of participants with objective response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Participants response|||Number
42898|NCT01420081|Secondary|Percentage of Participants With Objective Response for PF-05212384|Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions.|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Percentage of participants||95% Confidence Interval|Number
43038|NCT01416610|Primary|Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)|SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).|24 weeks after completing treatment, within 3 years, 6 months|||percentage of participants||95% Confidence Interval|Number
42899|NCT01420081|Secondary|Clinical Benefit Response for PF-04691502|"Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Participants|||Number
42900|NCT01420081|Primary|Percentage of Participants With Clinical Benefit Response for PF-05212384|Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||Percentage of participants||95% Confidence Interval|Number
42901|NCT01419977|Primary|Change in Clinical Pain Scores|The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with “0” corresponding to no pain at one end and “10” indicating the worst pain at the other.|Baseline to day 3|9 subjects were discharged prior to obtaining day 3 VAS score.||units on a scale||Standard Deviation|Mean
42902|NCT01419977|Primary|Change in Thrombin Generation Assay - Endogenous Thrombin Potential|Patients will have thrombin generation assay samples drawn on Day 1 and 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.||nM||Standard Deviation|Mean
42903|NCT01419977|Primary|Change in Clinical Pain Scores|The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with “0” corresponding to no pain at one end and “10” indicating the worst pain at the other.|Baseline to day 1|||units on a scale||Standard Deviation|Mean
42904|NCT01419977|Primary|Change in D-dimer|Patients will have D-dimer,for samples drawn on Day 1 and Day 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.||ng/mL||Standard Deviation|Mean
42905|NCT01419769|Primary|Safety - Freedom From Major Complications: SAE's|Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population||percentage of patients|||Number
42906|NCT01419769|Primary|Safety - Freedom From Major Complications: Tissue Injury|Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.|Through the duration of the 1-week post-stent removal study period|Per protocol population||percentage of patients|||Number
42907|NCT01419769|Primary|Safety - Freedom From Major Complications: Stent Migration/Dislodement|Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen|Through the duration of the 1-week post-stent removal study period|Per protocol population of subjects with stent successfully placed||percentage of patients|||Number
42908|NCT01419769|Primary|Safety - Freedom From Major Complications: Perforation|Subjects are free of surgery for access-site related perforation|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population||percentage of patients|||Number
42909|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Infection|Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Through the duration of the 1-week post-stent removal study period|Per protocol population||percentage of patients|||Number
42910|NCT01419769|Secondary|Clinical Success|Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol.||percentage of patients|||Number
42911|NCT01419769|Secondary|Effectiveness: Technical Success|Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.|Up to 60 days|Intent-to-Treat population||participants|||Number
42912|NCT01419769|Secondary|Effectiveness: Stent Removability at 30 Days and/or 60 Days|AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.|Up to 60 days|Patients who had AXIOS stent successfully placed during index procedure.||percentage of patients|||Number
42913|NCT01419769|Secondary|Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days|Stent lumen patency at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol with successful stent placement.||percentage of patients|||Number
42914|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Bleeding|Subjects are free of access site-related bleeding requiring transfusion|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population||percentage of patients|||Number
42915|NCT01419639|Primary|Change in Tumor Size From Baseline||1 Year|||% of change in tumor size from baseline|Participants|Full Range|Median
42916|NCT01419639|Secondary|Audiologic Response|"Defined as improvement in speech discrimination score (SDS), defined as an improvement in the score above the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment. Audiologic worsening: decrease in SDS score below the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment.~Patients with vestibular schwannomas will receive baseline audiograms within 28 days before enrollments and subsequent audiograms at the time of each MRI."|1 Year|||participants|||Number
42917|NCT01419639|Primary|Radiographic Response|To estimate the objective response rates to RAD001 in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas. Radiographic response for study purposes = greater than or equal to 15% reduction in tumor volume in any of the target tumors (partial response). Complete disappearance of any of the target tumors = complete response. MRI of the brain and spine will be performed every 3 months. If an objective response (15% reduction in tumor volume compared to baseline) is observed in any target tumor or stable disease, drug will be continued.|1 Year|||participants|Participants||Number
42918|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test~For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 6|The number of participants returning for the 6 week follow-up||Meters (m)||Standard Deviation|Mean
42919|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test~For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 3|The number of participants returning for the 3 week follow-up with complete data||Meters (m)||Standard Deviation|Mean
42920|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.|week 6|The number of participants returning for the second follow-up||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
42921|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.|week 3|The number of participants returning for the first follow-up with complete data.||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
42922|NCT01419314|Secondary|Function-Reach|"Forward reach test~For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 6|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.||Centimeters (cm)||Standard Deviation|Mean
42923|NCT01419314|Secondary|Function-Reach|"Forward reach test~For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 3|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.||Centimeters (cm)||Standard Deviation|Mean
42924|NCT01419314|Primary|Pain Scores|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 6|The total number of participants that completed the 6 week trial in each investigational group||units on a scale 0-100 (0=no pain)||Standard Deviation|Mean
42925|NCT01419314|Primary|Pain Scores at Week 3|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 3|The total number of participants returning for the first follow-up at week three with complete data.||units on a scale 0-100 (0= no pain)||Standard Deviation|Mean
42926|NCT01419249|Primary|Height Velocity Standard Deviation Score (SDS) at Year 1|Height velocity SDS was calculated as height velocity minus reference mean height velocity divided by standard deviation of the reference population. Height velocity SDS reflects the height velocity relative to a reference population of the same age and gender. Height velocity SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.||standard deviation score||Standard Deviation|Mean
42927|NCT01419249|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 1|Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender. Change from baseline in height SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.||standard deviation score||Standard Deviation|Mean
42981|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
42928|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in TS Girls Using Turner Syndrome Kabi-Pharmacia International Growth Study (TS KIGS) Predictive Model|TS KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum GH response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.|||||
42929|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in IGHD Children Using Growth Hormone Deficiency Kabi-Pharmacia International Growth Study (GHD KIGS) Predictive Model|GHD KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum growth hormone (GH) response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.|||||
42930|NCT01419249|Primary|Change From Baseline in Height at Year 1|Change from baseline in height at year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.||centimeter||Standard Deviation|Mean
42931|NCT01419236|Secondary|Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks|"The MSHQ-EjD-SF was a 4 item, self-reported questionnaire used for the assessment of EjD during the past month. The MSHQ-EjD-SF Bother/Satisfaction Score was based on Q4: If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this? Scores ranged from 0 (no problem with ejaculation), 1 (not at all bothered) to 5 (extremely bothered). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Bother/Satisfaction Score as fixed effects, and unstructured covariance structure for modeling correlation."|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
42932|NCT01419236|Secondary|Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks|IIEF: 15 item, self-reported questionnaire assessing overall erectile function and satisfaction during past month. Orgasmic Function Domain Score: sum of IIEF scores for Q9 and Q10. In Q9, participants (pts) identified how often they ejaculated when having sexual stimulation or intercourse. In Q10, pts identified how often they had a feeling of an orgasm with or without ejaculation when having sexual stimulation or intercourse. For each Q, scores ranged from 0 (no sexual stimulation or intercourse), 1 (almost never or never) to 5 (almost always or always). Total Orgasmic Function Domain Scores ranged from 0 to 10. LS mean of change from baseline calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Orgasmic Function Domain Score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
42933|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Reported is orgasmic pleasure rated from 0 (no pleasure) to 10 (excellent). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline orgasmic pleasure as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
42934|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the change from baseline number of sexual attempts at 16 weeks. LS mean of change from baseline was calculated using an analysis of covariance (ANCOVA) including treatment group, region, baseline total testosterone level, baseline ED severity (normal, mild, moderate, severe) as fixed effects, and centered baseline as a covariate.|Baseline, up to 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline; Last observation carried forward (LOCF).||sexual attempts||Standard Error|Least Squares Mean
42935|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is delayed ejaculation rated from 0 (did not ejaculate) to 10 (optimal/best ejaculate time). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline delayed ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
42936|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived force of ejaculation rated from 0 (could not ejaculate) to 10 (strong ejaculation). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline perceived force of ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
42937|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived volume of ejaculate rated from 0 (no ejaculate) to 10 (high volume of ejaculate). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
42938|NCT01419236|Secondary|Change From Baseline in Ejaculate Volume at 16 Weeks|The change from baseline in ejaculate volume was determined by actual measurement of semen volume in milliliters (mL). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||mL||Standard Error|Least Squares Mean
42939|NCT01419236|Primary|Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks|MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed‐effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level [≥200 nanograms per deciliter (ng/dL) versus (vs.) <200 ng/dL], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.||units on a scale||Standard Error|Least Squares Mean
42940|NCT01419197|Secondary|6-month and 1-year Survival (Final Analysis)|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
42941|NCT01419197|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
42942|NCT01419197|Secondary|Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle|The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.||Units on a scale||Standard Deviation|Mean
42943|NCT01419197|Secondary|Time to Pain Symptom Progression|Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
42945|NCT01419197|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with an objective response were included in the analysis. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
42946|NCT01419197|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
42947|NCT01419197|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
42948|NCT01419197|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.||Months||95% Confidence Interval|Median
42949|NCT01419184|Secondary|cSSSI-related Medical Resource Utilization and Costs|Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented.|Baseline (Day 0) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.||dollars (United States)||Standard Deviation|Mean
42950|NCT01419184|Secondary|30-day cSSSI-related Hospital Readmission Rates|Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented.|End of Hospital Stay (up to Day 14) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.||participants|||Number
42951|NCT01419184|Secondary|Participant Global Impression of Improvement (PGI-I) at Hospital Discharge|PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement.|End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable PGI-I data at hospital discharge.||units on a scale||Standard Deviation|Mean
42952|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)|Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility.|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable EQ-5D data at baseline and at hospital discharge.||units on a scale||Standard Deviation|Mean
42982|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
42953|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)|Pain was measured as the amount of pain experienced “right now” by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain.|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable BPI-SF data at baseline and at hospital discharge.||units on a scale||Standard Deviation|Mean
42954|NCT01419184|Primary|Infection-Related Hospital Length of Stay|Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.|Baseline (Day 0) through the End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. As the end of the IRLOS depended upon the participant’s course of treatment, no static set of items were answered to determine if a participant had complete data.||Hours||Standard Deviation|Mean
42955|NCT01419171|Secondary|Clinical Procedural Success Rate|Clinical Procedural Success: lesion diameter stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. Summarized per patient.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of patients||95% Confidence Interval|Number
42956|NCT01419171|Secondary|Periprocedural Endpoints: Technical Success Rate|Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day|||percentage of patients|Participants|95% Confidence Interval|Number
42957|NCT01419171|Secondary|12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42958|NCT01419171|Secondary|12 Month All Death/MI/TVR Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42959|NCT01419171|Secondary|12 Month All Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42960|NCT01419171|Secondary|12 Month Cardiac Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42961|NCT01419171|Secondary|12 Month All Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42962|NCT01419171|Secondary|12 Month Non-cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42963|NCT01419171|Secondary|12 Month Cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42964|NCT01419171|Secondary|12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42983|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
42965|NCT01419171|Secondary|12 Month Target Vessel Failure (TVF) Rate|Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42966|NCT01419171|Secondary|12 Month Target Vessel Revascularization (TVR) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42967|NCT01419171|Secondary|12 Month Target Lesion Revascularization (TLR) Rate|Any ischemia-driven repeat percutaneous coronary intervention (PCI), to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.||percentage of participants||95% Confidence Interval|Number
42968|NCT01419171|Primary|9-month Target Lesion Failure (TLF) Rate|The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|Nine Month|N=323 (5 patients were not evaluable for the endpoint: Follow-up < 240 days and event-free)||percentage of participants||95% Confidence Interval|Number
42969|NCT01419028|Secondary|Invasive Ventilator-free Survival Time|Invasive ventilator-free survival is defined as the time during which the patient is alive and not invasively ventilated. For the purpose of this study, invasive ventilation is defined as mechanical ventilation via intubation of trachaeostomy.|Retrospective data collected on or before the date of abstraction.|||days||95% Confidence Interval|Median
42970|NCT01419028|Primary|Survival|Overall survival is defined as the time from birth to time of death.|Retrospective data collected on or before the data of abstraction.|||days||95% Confidence Interval|Median
42971|NCT01418937|Primary|Number of Pregnant Subjects Reporting Pregnancy Outcomes|The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.|Throughout the study period (from Month 0 up to Month 12)|The analysis was performed on the number of pregnant subjects participating in the study.||Subjects|||Number
42972|NCT01418937|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered||Subjects|||Number
42973|NCT01418937|Primary|Number of Subjects With Potential Immune-mediated Disease (pIMDs)||Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered||Subjects|||Number
42974|NCT01418937|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered||Subjects|||Number
42975|NCT01418703|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR|||mg/dL||Standard Deviation|Mean
42976|NCT01418703|Secondary|Percent Time Spent in Near Normoglycemia|Comparison of time spent in near normoglycemia (3.9 to 10 mmol/mL) in open-loop vs closed-loop sCTR and eCTR.|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR|||percentage of time||Standard Deviation|Mean
42977|NCT01418703|Primary|Hypoglycemic Events|Number of hypoglycemic events below 70 mg/dL per patient per day|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR|||events/admission per patient||Standard Deviation|Mean
42978|NCT01418365|Primary|Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set||ng/ml||Standard Deviation|Mean
42979|NCT01418365|Primary|Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consists of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ng*h/ml||Standard Deviation|Mean
42980|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
42984|NCT01418209|Primary|Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 8 study assessment to produce a mean daily frequency for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||number of hot flashes per day||95% Confidence Interval|Mean
42985|NCT01418209|Secondary|Severity of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS severity for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
42986|NCT01418209|Secondary|Severity of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS severity for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||units on a scale||95% Confidence Interval|Mean
42987|NCT01418209|Primary|Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 4 study assessment to produce a mean daily frequency for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.||number of hot flashes per day||95% Confidence Interval|Mean
42988|NCT01418001|Secondary|Pathologic Response|will be assessed by both MRI and by pathologic review after surgery. An estimate of each response rate and the 95% CI will be provided|2 years||||||
42989|NCT01418001|Primary|Overall Objective Response|Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Every 6 weeks|||participants|||Number
42990|NCT01417936|Secondary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||Subjects|||Number
42991|NCT01417936|Secondary|Volume of Distribution (Vz)|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||milliliter/kilogram||Standard Deviation|Mean
42992|NCT01417936|Secondary|Time to Reach Minimum Serum Concentration (Tmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||hour||Standard Deviation|Mean
42993|NCT01417936|Secondary|Time to Reach Maximum Serum Concentration (Tmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||hour||Standard Deviation|Mean
42994|NCT01417936|Secondary|Terminal Half Life (T1/2)|The apparent terminal half-life was defined as the time required for the serum concentration of Sym004 to decrease 50% in the final stage of its elimination.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||hour||Standard Deviation|Mean
42995|NCT01417936|Secondary|Clearance (CL)|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||milliliter/hour/kilogram||Standard Deviation|Mean
42996|NCT01417936|Secondary|Minimum Serum Concentration (Cmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram/milliliter||Standard Deviation|Mean
42997|NCT01417936|Secondary|Maximum Serum Concentration (Cmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram/milliliter||Standard Deviation|Mean
42998|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf])|The AUC (0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram-hour/milliliter||Standard Deviation|Mean
43073|NCT01416129|Primary|Quality of Life|Validated surveys will be used to solicit participants' subjective experience and feedback.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||||
42999|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168])|The AUC (0-168h) was estimated by determining the total area under the curve of the concentration versus time curve.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.||microgram-hour/milliliter||Standard Deviation|Mean
43000|NCT01417936|Secondary|Number of Subjects With Detectable Biomarkers at Any Visit|The biomarkers human papilloma virus (HPV), mutated epidermal growth factor receptor (EGFRvIII), c-MET and human epidermal growth factor receptor (HER) 2, HER3 were analyzed only in tumor cells while EGFR, phosphorylated epidermal growth factor receptor (pEGFR), and Ki-67 were analyzed both in tumor and skin biopsy cells.|Weeks 0 and 4; and 4 weeks after last dose|"The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. n signifies subjects evaluable for specified biomarker type."||Subjects|||Number
43001|NCT01417936|Secondary|Overall Survival Time|Overall survival time was defined as the time from first infusion of Sym004 until date of death. Subjects who withdraw the consent or lost to follow-up were censored.|Time from first infusion of Sym004 until death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||days||95% Confidence Interval|Median
43002|NCT01417936|Secondary|Time to Progression (TTP)|The TTP was defined as the time from first infusion of Sym004 until disease progression according to RECIST Version 1.1 criteria. Disease progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The subjects who died without prior assessment of PD were censored for TTP.|Time from first infusion of Sym04 until disease progression, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||days||95% Confidence Interval|Median
43003|NCT01417936|Secondary|Duration of Overall Response|Duration of overall response was defined as the time from the first time point where measurement criteria are met for CR or PR until first date of recurrence or PD was objectively documented according to RECIST Version 1.1. Duration of overall response was censored at date of last imaging data of measured lesions if no confirmation of recurrence or PD was available.|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|Duration of overall response could not be calculated as no subject showed CR or PR.|||||
43004|NCT01417936|Secondary|Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate)|"Best objective tumor response was defined as the occurrence of complete response (CR), partial response (PR), stable disease (SD), or PD according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.~Objective response was defined as the occurrence of CR or PR according to RECIST Version 1.1. Disease control was defined as the occurrence of CR, PR or SD according to RECIST Version 1.1.~CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm; PR: At least a 30% decrease in the sum of diameters of all - lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial."|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||Percentage of subjects||95% Confidence Interval|Number
43005|NCT01417936|Primary|Progression Free Survival (PFS) Time|The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates.|Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.||days||95% Confidence Interval|Median
43006|NCT01417481|Secondary|Changes in Other Spirometric Variables|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks|||Percentage of baseline||Standard Error|Mean
43007|NCT01417481|Secondary|Changes in FEV1, FEF25, and FEFmax|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks|||Percentage of baseline||Standard Error|Mean
43008|NCT01417481|Secondary|Changes in Pulse Oximetry, FEV1/FVC, and FEF50.|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks|||Percentage of baseline||Standard Error|Mean
43009|NCT01417481|Secondary|Changes in Score for Sputum Production, Dyspnea and Global Symptoms|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).~In the symptoms questionnaire, each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks|||Percentage of baseline||Standard Error|Mean
43010|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|||log (percent change)||Standard Error|Mean
43011|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (IL-6)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children did not expectorate at some visits. Thus, only a non-paired population of 9 children under glycine and 11 under placebo could be analyzed.||log (percent change)||Standard Error|Mean
43012|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.||log (percent change)||Standard Error|Mean
43013|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (Other Than IL-6 and G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children at some visits could not give an appropriate sputum sample. Thus, only a non-paired population of 9 (glycine group) and 11 (placebo group) children could be analyzed.||log (percent change)||Standard Error|Mean
43014|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (Other Than TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.||log (percent change)||Standard Error|Mean
43015|NCT01417481|Secondary|Changes in Clinical Data Scores (Other Than Sputum Production, Dyspnea and Global Symptoms)|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).~Each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks|||Percentage of baseline||Standard Error|Mean
43016|NCT01417455|Primary|Osteoclast Activity Ex-vivo|Total area resorbed by osteoclasts as percentage of total area analyzed|at baseline and at 6 months|||percentage of resorbed area||Inter-Quartile Range|Median
43017|NCT01417455|Primary|Osteoclast Differentiation Ex-vivo|Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.|at baseline and at 6 months|||OC/mm2||Inter-Quartile Range|Median
43018|NCT01417377|Secondary|Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)||Up to 6 months|The number of doses were not collected because the participants never achieved Hb level of 11 to 12 g/dL.|||||
43019|NCT01417377|Secondary|Number of Dose Adjustments Required to Maintain Hb Levels||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.|||||
43020|NCT01417377|Secondary|Time to Achieve Hb Level to 11-12 g/dL||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.|||||
43021|NCT01417377|Primary|Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study||Month 4 up to Month 6|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.|||||
43022|NCT01417195|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics.|Day 1 up to Day 20|Safety population||participants|||Number
43023|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 6|"Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 6|Intent to treat population for the combination treatment arm only||participants|||Number
43024|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 1|"Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 1|Intent to treat population for the combination treatment arm only||participants|||Number
43074|NCT01416129|Primary|Balance and Stability|Balance and stability will be assessed for limits of stability and postural stability.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||||
43025|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6|Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 6|Intent to treat population for the combination treatment arm only||participants|||Number
43026|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1|Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 1|Intent to treat population for the combination treatment arm only||participants|||Number
43027|NCT01417195|Primary|Fertilization Rate|The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100.|approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))|Intent to treat population||percentage of oocytes retrieved||Standard Deviation|Mean
43028|NCT01417104|Other Pre-specified|Change From Baseline in Resting Diastolic Blood Pressure|Difference between end of treatment and baseline in resting diastolic blood pressure|baseline to end of treatment ( up to 36 weeks)|Intent to treat analysis including only participants who had at least one post-baseline assesment||mm Hg||95% Confidence Interval|Mean
43029|NCT01417104|Secondary|Change in the Percentage Wall Volume (PWV) Between Baseline and End of Treatment|Using an approach similar to intravascular atheroma volume calculations, percentage wall volume (PWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated. and a difference between baseline and end of treatment was calculated.|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI not analyzable, 23 final MRI not obtained due to trial termination||Percentage of the Outer Wall Volume||Standard Deviation|Mean
43030|NCT01417104|Primary|Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment|"All patients underwent imaging using a 3T, MRI system. The MRI sequence method used for wall depiction was a 3D, fat suppressed, dark blood, turbo spin echo sequence with variable flip angles (SPACE). Following co-registration of pre and post treatment MR images, and generation of MPR sections, images were magnified, contrast adjusted and patient/exam identifier information was removed and replaced by pre-assigned code to blind images for measurements.~An experienced observer performed manual measurements of lumen and lumen plus wall areas by delineating the inner border and the outer border of the vessel wall in each cross-section image of the aorta. Using an approach similar to intravascular atheroma volume calculations, normalized total aortic wall volume (TWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated."|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI data sets were not analyzable ( low quality images), and 23 post-treatment MRI not obtained ( <17 weeks on drug when trial terminated owing to ALTITUDE results)||mm3||Standard Deviation|Mean
43031|NCT01416610|Secondary|Beck Depression Inventory (BDI) Score by Visit|The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
43032|NCT01416610|Secondary|Beschwerdeliste (BL) Score by Visit|"The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit."|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
43033|NCT01416610|Secondary|Fatigue Severity Scale (FSS) Score by Visit|The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
43034|NCT01416610|Secondary|Short Form Health Survey (SF-36) Scores by Visit|The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point||units on a scale||Standard Deviation|Mean
43035|NCT01416610|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|by end of follow-up, within 3 years, 6 months|Participants who completed treatment||percentage of participants||95% Confidence Interval|Number
43036|NCT01416610|Secondary|Percentage of Participants With End of Treatment Response|A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|at end of treatment, within 3 years, 6 months|||percentage of participants||95% Confidence Interval|Number
43075|NCT01416129|Primary|Gait|Gait will be assessed in terms of biomechanics and spatiotemporal parameters.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||||
43039|NCT01416571|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43040|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 20 and from Day 0 to Day 84.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43041|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43042|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43043|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43044|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43045|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43046|NCT01416571|Secondary|Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43047|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43048|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43049|NCT01416571|Secondary|Duration of Solicited General Symptoms After Vaccination.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.||days||Inter-Quartile Range|Median
43050|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43051|NCT01416571|Secondary|Duration of Solicited Local Symptoms After Vaccination.|Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.||days||Inter-Quartile Range|Median
43052|NCT01416571|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.||Subjects|||Number
43053|NCT01416571|Secondary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||ratio||95% Confidence Interval|Geometric Mean
43054|NCT01416571|Secondary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||Subjects|||Number
43055|NCT01416571|Secondary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||Subjects|||Number
43056|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||titers||95% Confidence Interval|Geometric Mean
43057|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.||Subjects|||Number
43058|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||titers||95% Confidence Interval|Geometric Mean
43076|NCT01416025|Primary|Number of Participants With Treatment Failure|"The primary endpoint of the study will be a binary outcome, called Failure, defined as one of the following: measured at 42 days from initiation of drug administration:~Progression of underlying infection (clinical failure)~Death~Development of a voriconazole-associated SAE: LFTs, Rash, Visual disturbance, Neurologic abnormality (e.g: hallucinations)"|42 days|||participants|||Number
43059|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||Subjects|||Number
43060|NCT01416571|Primary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||Subjects|||Number
43061|NCT01416571|Primary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||ratio||95% Confidence Interval|Geometric Mean
43062|NCT01416571|Primary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.||Subjects|||Number
43063|NCT01416272|Secondary|Visual Acuity - High Contrast|High contrast visual acuity measured with high ambient illumination (HCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.|||||
43064|NCT01416272|Secondary|Visual Acuity - Low Contrast|Low contrast visual acuity measured with high ambient illumination (LCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.|||||
43065|NCT01416272|Primary|Comfort|Symptoms and complaints measured on an analog scale|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.|||||
43066|NCT01416155|Secondary|Mean Change From Baseline in the Assessment of Expanded Disability Status Scale (EDSS) up to Week 192|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.|Day 1 up to Week 192|n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
43067|NCT01416155|Secondary|Adjusted Annualized Relapse Rate|Clinical relapses are defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist. The annualized relapse rate is calculated overall as the total number of relapses experienced in the study divided by the number of days followed in the study, and the ratio multiplied by 365. Obtained from a Poisson regression model, adjusted for the baseline relapse rate from study 101MS203 (NCT01440101).|Day 1 up to approximately 50 months|||relapses per subject-years|Participants|95% Confidence Interval|Number
43068|NCT01416155|Primary|Number of Participants With Serum Antibodies to Natalizumab|Negative is defined as negative for antibodies at all post-baseline results. Transient positivity is defined as only 1 positive result. Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Day 1 up to approximately 50 months|Immunogenicity population: all participants who had received at least 1 infusion of BG00002, were negative for BG00002 antibodies at baseline and had at least 1 nonmissing post-baseline assessment of antibody status.||participants|||Number
43069|NCT01416155|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|Day 1 through First Follow-Up (12 Weeks After Last Infusion) +/- 7 days. Approximately 62 months|Safety population: all participants who received at least 1 dose of study treatment.||participants|||Number
43070|NCT01416142|Secondary|Preference for Test Lens|Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.|During the movie (Visit 2)|All eligible, dispensed subjects||participants|||Number
43071|NCT01416142|Primary|Visual Acuity|Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.|Screening visit (Visit 1) and one week follow-up(Visit 3)|Mean scores are based on the number of eyes with nonmissing logMAR VAs. All eligible, dispensed eyes while wearing spectacles vs. wearing PureVision2 lenses.||logMAR|Participants|Standard Deviation|Mean
43072|NCT01416129|Primary|Socket Pressure|Pressure sensors are placed on the skin and measured.|10 minutes after fitting with both sockets|||mm Hg||Standard Deviation|Mean
43077|NCT01415986|Secondary|Changes in the Quality of Life (QoL)|The change in the overall score of the University of Washington quality of life questionnaire (UW-QOL). Each of the domain-specific items is scored from 0 (worst quality of life (QOL) to 100 (Best QOL). The composite score is created by averaging the scores.|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment.|No data was collected because the participant was lost to follow up.|||||
43078|NCT01415986|Primary|Local Tumor Response to Interstitial Photodynamic Therapy (I-PDT) With Temoporfin|Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment|No data was collected because the participant was lost to follow up.|||||
43079|NCT01415960|Secondary|Determination of Leuprolide Tmax|Leuprolide Pharmacokinetic Parameters (PK Population).|84 days|||day||Standard Deviation|Mean
43080|NCT01415960|Secondary|Safety Endpoints|"The WHO/ECOG, bone pain, urinary pain and urinary symptoms data reported are the most frequent percentage at the assessment time.~The WHO/ECOG performance status was summarized using the 0 to 4 WHO/ECOG performance status scale. (0= fully active, able to carry on all pre-disease performances without restriction).~Bone pain, urinary pain and urinary symptoms were determined using a 10-point scale (1= no pain/symptoms, 10= worst pain/symptom imaginable)."|168 Days|Safety endpoints adverse events (AEs), local tolerability, vital signs, performance status, bone pain, urinary pain, and urinary symptoms, occurrence of hot flushes and clinical laboratory and electrocardiogram (ECG) results.||percentage of participants|||Number
43081|NCT01415960|Secondary|Determination of Leuprolide Cmax|Leuprolide Pharmacokinetic Parameters (PK Population).|84 days|||ng/mL||Standard Deviation|Mean
43082|NCT01415960|Secondary|Prostate-specific Antigen (PSA) Concentrations|For purposes of calculating summary statistics, any concentration values Below Limit Quantification (BLQ) were to be assigned ½ the Low Limit Quantification (LLOQ) (LLOQ=0.36). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.|168 days|||ng/mL||Standard Deviation|Mean
43083|NCT01415960|Secondary|Follicle-stimulating Hormone (FSH)|For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=3.66). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was to be calculated for that time point.|168 days|||mIU/mL||Standard Deviation|Mean
43084|NCT01415960|Secondary|Determination of Serum Luteinizing Hormone (LH)|For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=2.00). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.|168 days|||mIU/mL||Standard Deviation|Mean
43085|NCT01415960|Primary|Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168.|The primary endpoint was testosterone ≤ 0.5 ng/mL assessed on Days 28, 84, and 168. Thereby, maintenance of castration was to be demonstrated through Day 168 with no missing data at these key time points, unless the missing data were due to an event unrelated to the study drug (ITT patients).|168 days|||percentage of participants||95% Confidence Interval|Number
43086|NCT01415921|Primary|Post Exercise Heart Rate Recovery|Change in heart rate from peak exercise to 1 minute post-exercise (beats per minute)|12 weeks|||beats per minute||Standard Deviation|Mean
43087|NCT01415921|Primary|Baseline Heart Rate||Baseline|||beats per minute||Standard Deviation|Mean
43088|NCT01415908|Secondary|Hospital Stay||During the time of hospital stay|||days||Standard Deviation|Mean
43089|NCT01415908|Secondary|Blood Loss||During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group|||mls||Standard Deviation|Mean
43090|NCT01415908|Secondary|Operative Time||Operative time was recorded from skin incision to wound closure|||minutes||Standard Deviation|Mean
43091|NCT01415908|Secondary|Percent of Subjects Who Had Additional Surgical Procedures/Interventions||24 months|||percentage of participants|||Number
43092|NCT01415908|Secondary|Success Rate of General Health Status|The Medical Outcomes Study 36-Item Short Form (SF-36) health survey was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The scores for PCS and MCS are between 0 and 100, with higher scores denoting better quality of life. To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: post-operative score - pre-operative score >= 0. The results are reported as percent of subjects who have SF-36 PCS success, SF-36 MCS success, and overall SF-36 success.|24 months|||percentage of participants|||Number
43093|NCT01415908|Secondary|Success Rate of Leg Pain|Numerical rating scales were used to evaluate leg pain intensity and frequency. Subjects rated their leg pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, subjects recorded their leg pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” The total leg pain score were the sum of pain intensity and frequency scores. Success rate of leg pain is reported as percent of subjects whose leg pain improvement met: pre-operative score - post-operative score > 0.|24 months|||percentage of participants|||Number
43094|NCT01415908|Secondary|Success Rate of Back Pain|Numerical rating scales were used to evaluate back pain intensity and frequency. Subjects rated their back pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, subjects recorded their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” The total back pain score were the sum of pain intensity and frequency scores. Success rate of back pain is reported as percent of subjects whose back pain improvement met: pre-operative score - post-operative score > 0.|24 months|||percentage of participants|||Number
43095|NCT01415908|Secondary|Success Rate of Neurological Status|Neurological status was assessed in six sections: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections had a number of elements. Success rate of neurological status is reported as percent of subjects whose neurological status was maintained or improved in three key neurological assessments—motor, sensory, and deep tendon reflexes.|24 months|||percentage of participants|||Number
43096|NCT01415908|Secondary|Success Rate of Oswestry Disability Index|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.|24 months|||percentage of participants|||Number
43097|NCT01415908|Secondary|Rate of Fusion Success|"Rate of fusion success is reported as percent of subjects having fusion success. The fusion success was defined radiologically as:~evidence of bridging bone;~no evidence of motion;~no evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface."|24 months|Eight investigational and 3 control subjects were evaluated for fusion success at 24 months.||percentage of participants|||Number
43098|NCT01415908|Primary|Rate of Overall Success|"Rate of overall success is reported as percent of subjects who met all of the following criteria:~fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion);~pain/disability (Oswestry Disability Index) success;~neurological status success;~no serious adverse event classified as implant associated or implant/surgical procedure associated;~no additional surgical procedure classified as a failure."|24 months|||percentage of participants|||Number
43099|NCT01415531|Secondary|Trough Seated Systolic Blood Pressure (SBP)|Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment||mm Hg||Standard Deviation|Mean
43100|NCT01415531|Primary|Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment||mmHG||Standard Deviation|Mean
43101|NCT01415518|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the whole treatment period (12 weeks)|||times/day||95% Confidence Interval|Least Squares Mean
43102|NCT01415518|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
43103|NCT01415518|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the last week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
43104|NCT01415518|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period (12 weeks)|||exacerbations/12 weeks||95% Confidence Interval|Least Squares Mean
43105|NCT01415518|Secondary|COPD Symptoms Sputum|Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)|||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
43106|NCT01415518|Secondary|COPD Symptoms - Cough|Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)|||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
43107|NCT01415518|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)|||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
43108|NCT01415518|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period (12 weeks)|||times/day||95% Confidence Interval|Least Squares Mean
43109|NCT01415518|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
43110|NCT01415518|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment|||times/day||95% Confidence Interval|Least Squares Mean
43111|NCT01415518|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period (12 weeks)|||L/min||95% Confidence Interval|Least Squares Mean
43112|NCT01415518|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured at 5 minutes after inhalation of study drug in the first week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
43113|NCT01415518|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
43114|NCT01415518|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period (12 weeks)|||L/min||95% Confidence Interval|Least Squares Mean
43115|NCT01415518|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured before inhalation of study drug in the first week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
43116|NCT01415518|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment|||L/min||95% Confidence Interval|Least Squares Mean
43117|NCT01415518|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
43118|NCT01415518|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
43119|NCT01415518|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
43120|NCT01415518|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
43121|NCT01415518|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|||Ratio||95% Confidence Interval|Geometric Mean
43122|NCT01415518|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS||Ratio||95% Confidence Interval|Geometric Mean
43123|NCT01415518|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS||Ratio||95% Confidence Interval|Geometric Mean
43124|NCT01415518|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS||Ratio||95% Confidence Interval|Geometric Mean
43125|NCT01415453|Primary|Phosphene Perception in Response to Ultrasound Pulse.|The investigators will test the hypothesis that compression of retinal nerves by ultrasound force will cause perception of light (phosphenes) in blind subjects lacking functioning photoreceptors (retinitis pigmentosa). With each of two 5 msec ARFI exposures, if the subject either perceived the spark of light (phosphene), then it was documented as a positive response; if they did not, it was marked as a negative response.|Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.|Only one subject was examined.||participants|||Number
43126|NCT01415401|Secondary|Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|This analysis population includes all subjects who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.||percentage of participants|||Number
43127|NCT01415401|Primary|Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|This analysis population includes all subjects who received study medication and had at least one on-therapy study visit. Last observation carried forward (LOCF) was used.||mmHg||Standard Deviation|Mean
43170|NCT01414192|Secondary|Mortality Rate|The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.|up to 48 months|All enrolled participants with available data.||Deaths per 100,000 patient-years||95% Confidence Interval|Number
43128|NCT01415349|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.||ng*h/ml||Standard Deviation|Mean
43129|NCT01415349|Primary|Maximum Plasma Concentration (Cmax) for SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.||ng/ml||Standard Deviation|Mean
43130|NCT01415232|Primary|Epidural Depth|epidural depth measured from the skin to the epidural space with the use of ultrasound done just prior to labor epidural catheter insertion for relief of labor pain.|at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)|per protocol||correlation coefficient||95% Confidence Interval|Number
43131|NCT01415232|Primary|Estimate Epidural Depth in Morbidly Obese Parturients (BMI>40kg/m2)|To determine the correlation between actual epidural needle depth (ND) and estimated epidural depth (Est-D) with the use of ultrasound and the epidural depth equation (EQ-US).|Five minutes for ultrasound measurement||||||
43132|NCT01414855|Secondary|Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count||Up to approximately 24 months||||||
43133|NCT01414855|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)|Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||day*μg/mL||Standard Deviation|Mean
43134|NCT01414855|Secondary|Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab|V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||mL||Standard Deviation|Mean
43135|NCT01414855|Secondary|Pharmacokinetics: Clearance (Cl) for Obinutuzumab|Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||mL/day||Standard Deviation|Mean
43136|NCT01414855|Secondary|Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab|T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||days||Standard Deviation|Mean
43137|NCT01414855|Secondary|Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab|Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.||μg/mL||Standard Deviation|Mean
43138|NCT01414855|Secondary|Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)|"SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes.~Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae.~Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated."|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|Participants from the Safety population, all randomized participants who received at least 1 dose of study drug, who received shorter duration infusions.||participants|||Number
43139|NCT01414855|Secondary|Percentage of Participants With Adverse Events as a Measure of Safety|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|Safety population included all randomized participants who received study drug.||percentage of participants|||Number
43140|NCT01414855|Secondary|Duration of Response (DOR)|DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause.|From the first dose of study treatment to response assessment (Up to 28 months)|All participants with data available. Participants who had not progressed, relapsed, or died at the time of analysis, the participants was censored for duration of response at the date of the last valid response assessment.||months||Full Range|Median
43171|NCT01414192|Secondary|Percentage of Participants With at Least 1 Discontinuation of Study Drug|The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.|up to 48 months|All enrolled participants with available data.||Percentage of Participants|||Number
43141|NCT01414855|Secondary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.|From the first dose of study treatment to PFS assessment (Up to 28 months)|All participants. Patients who had not progressed, relapsed or died at the time of analysis were censored on the date of last valid disease assessment. If no tumor assessments were performed after the baseline visit, the patient was censored for PFS at the date after the first dose of study treatments.||months||Full Range|Median
43142|NCT01414855|Secondary|Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants||percentage of participants||95% Confidence Interval|Number
43143|NCT01414855|Secondary|Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.||percentage of participants||95% Confidence Interval|Number
43144|NCT01414855|Primary|Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants||percentage of participants||95% Confidence Interval|Number
43145|NCT01414855|Primary|Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.||percentage of participants||95% Confidence Interval|Number
43146|NCT01414634|Primary|Number of Adverse Events||3 months after treatment|||Number of AE|||Number
43147|NCT01414634|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||12 months||||||
43148|NCT01414413|Secondary|Adult Mortality|Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention|The first 6-months following availability of home-based HIV testing||||||
43149|NCT01414413|Secondary|Adherence to ART|Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period|First 6-months following availability of home-based HIV testing||||||
43150|NCT01414413|Secondary|Loss to Retention|Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months|The first 6-months following availability of home-based HIV testing|||participants|||Number
43151|NCT01414413|Secondary|Reporting of HIV-positive Results|Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period|The first 6-months following availability of home-based HIV testing|||participants|||Number
43152|NCT01414413|Secondary|Uptake of Home-based HIV Testing|Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study.|The first 6-months following home assessment and initiation of ART being made available|||participants|||Number
43153|NCT01414413|Primary|ART Initiation|Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.|First six months following introduction of home-based HIV testing|||participants|||Number
43154|NCT01412983|Secondary|Overall Comfort|The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.|One week|All eligible dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
43155|NCT01412983|Primary|Visual Acuity|The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.|One week|All eligible dispensed eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
43156|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as a CD19 result ≥ 0.07 × 10^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) [PD before B-cell recovery or PD within 45 days after recovery] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|Randomization to Clinical data cut-off: 27 April 2013 (Up to 1.5 years)|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, with B-Cell depletion.||Participants|||Number
43157|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell depletion was defined as a CD19 result < 0.07 × 10^9/L after at least one dose of study drug has been administered.|Randomization to Clinical data cut-off: 27 April 2013 (Up to 1.5 years)|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, who had data available for this outcome measure.||Participants|||Number
43158|NCT01414205|Secondary|PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). T1/2 was reported in Days.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||Days||Geometric Coefficient of Variation|Geometric Mean
43159|NCT01414205|Secondary|PK Parameter: Volume of Distribution at Steady State (Vss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss is reported in liters.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||Liters||Geometric Coefficient of Variation|Geometric Mean
43160|NCT01414205|Secondary|PK Parameter: Clearance at Steady State (CLss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLss is reported in milliliters per day (mL/day).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||mL/day||Geometric Coefficient of Variation|Geometric Mean
43161|NCT01414205|Secondary|PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in day times micrograms per milliliter (day*μg/mL).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.||day*μg/mL||Geometric Coefficient of Variation|Geometric Mean
43162|NCT01414205|Secondary|PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for Pharmacokinetic (PK) Parameter Cmax after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Day 148 (at end of infusion)|All randomized participants who received study drug with PK data available for analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
43163|NCT01414205|Secondary|Percentage of Participants With Adverse Events Leading to Study Discontinuation|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.|Randomization to Clinical data cut-off: 27 April 2013 (Up to 1.5 years)|Safety population included all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
43164|NCT01414205|Secondary|Percentage of Participants With Adverse Events of Interest|Adverse Events of interest for this study were: serious infusion related reactions during or within 24 hours of infusion, serious neutropenia, serious infection, tumor lysis syndrome and Hepatitis B reactivation.|Randomization to Clinical data cut-off: 27 April 2013 (Up to 1.5 years)|Safety population included all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
43165|NCT01414205|Secondary|Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|"An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator.~Additional information about AEs can be found in the Adverse Event Section"|Randomization to Clinical data cut-off: 27 April 2013 (Up to 1.5 years)|Safety population included all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
43166|NCT01414205|Secondary|Overall Survival (OS)|OS was defined as the time from randomization until death from any cause.|up to 3.5 years||03/2017||||
43167|NCT01414205|Secondary|Duration of Response|Duration of response was defined as the first occurrence of a documented, objective response until the first occurrence of relapse or progression or death from any cause.|up to 3.5 years||03/2017||||
43168|NCT01414205|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.|up to 3.5 years||03/2017||||
43169|NCT01414205|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (Cri) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes < 4 x 10^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils > 1.5 x 10^9/L, Platelets > 100 x 10^9/L, Hemoglobin >11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils > 1.5 x 10^9/L or > 50% of pretreatment value, Platelets > 100 x 10^9/L or 50% of pretreatment value and Hemoglobin > 11 g/dL or > 50% of pretreatment value.|Week 32|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
43172|NCT01414192|Secondary|Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months|Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.|up to 48 months|All enrolled participants with available data. The ezetimibe monotherapy with or without previous lipid-lowering treatment groups were combined for this outcome.||Percentage of Participants|||Number
43173|NCT01414192|Secondary|Percentage of Participants With CV Risk Factors|Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.|At enrollment (baseline)|All enrolled participants with available data||Percentage of Participants|||Number
43174|NCT01414192|Secondary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months|LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.|Baseline and Month 12|All participants with available data for endpoint. The ezetimibe plus statin and ezetimibe/simvastatin arms were combined for this outcome.||Percentage Change||Full Range|Mean
43175|NCT01414192|Primary|Rate of Cardiovascular (CV) Events|Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.|up to 48 months|All participants with available data for endpoint.||Events per 1000 patient-years||95% Confidence Interval|Number
43176|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16|The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43177|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43178|NCT01414166|Secondary|Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16|The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43179|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16|The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43180|NCT01414166|Secondary|Percent Change From Baseline in Non-HDL-C at Week 16|The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43181|NCT01414166|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43182|NCT01414166|Secondary|Percent Change From Baseline in HDL-C at Week 16|The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43183|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16|The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed|||||
43184|NCT01414166|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16|The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.|Baseline and Weeks 12 to 16|Due to early study termination, this efficacy endpoint was not analyzed.|||||
43185|NCT01414153|Secondary|Proportion of Subjects With Adverse Events.||Baseline to Day 120|||percentage of subjects|||Number
43186|NCT01414153|Secondary|Proportion of Subjects With ETDRS BCVA of 20/40 or Better.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. 20/40 Snellen corresponds to a range of 69-73 letters by ETDRS.|Baseline to Day 120|||percentage of subjects||80% Confidence Interval|Number
43187|NCT01414153|Secondary|Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. One line is equivalent to 5 letters, so a loss of 3 lines is a loss of 15 letters.|Baseline to Day 120|||percentage of subjects||80% Confidence Interval|Number
43188|NCT01414153|Secondary|Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120|||percentage of subjects||80% Confidence Interval|Number
43189|NCT01414153|Secondary|Mean Change in CNV Lesion Area as Determined by Fluorescein Angiography (FA).||Baseline to Day 120|ITT population||mm^2||Standard Error|Least Squares Mean
43190|NCT01414153|Secondary|Mean Change in Central Subfield Retinal Thickness||Baseline to Day 120|ITT population||μM||Standard Error|Least Squares Mean
43191|NCT01414153|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120|Intent-to-treat (ITT) Population||letters||Standard Deviation|Least Squares Mean
43192|NCT01414036|Secondary|Use of Other Tobacco Treatment Support|self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.||participant|||Number
43193|NCT01414036|Secondary|Stage of Change With Regard to Smoking Cessation|Stage of change is assessed at baseline and 3 months. Three months after study entry, 7 of patient navigation-intervention participants who had initially said that they did not have a time frame in mind for quitting reported that they now had a time frame in mind for quitting, relative to 1 of ETC-control participants.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.||participant|||Number
43194|NCT01414036|Primary|Engagement in Smoking Cessation Treatment|This is a dichotomous variable, Y/N, based on a) completion of > 1 quit line counseling session (based on self-report) OR b) > 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of > 1 session of a BMC smoking cessation group (medical record review).|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.||participant|||Number
43195|NCT01413958|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)|"The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3~questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains."|Up to Day 8|The Intent-To-Treat Population was used in this analysis. There were 285 evaluable participants for the Placebo Group at Day 8.||Scores on a scale||Standard Deviation|Mean
43196|NCT01413958|Secondary|Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 5 and 7, 287 on Days 1, 3, 4 and 286 on Days 2 and 6. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 5, 6 and 285 on Day 7 and 284 on Day 4.||Scores on a scale||Standard Deviation|Mean
43197|NCT01413958|Secondary|Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 1, 2, 3, 4, 5, 7 and 286 evaluable participants at Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 3, 5, 6 and 285 on Days 2, 4, 7.||Scores on a scale||Standard Deviation|Mean
43198|NCT01413958|Secondary|Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Day 5, 287 on Days 1, 3, 4, 6 and 286 on Day 2. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, 6, 285 on Days 3 and 7 and 284 on Day 4.||Scores on a scale||Standard Deviation|Mean
43199|NCT01413958|Secondary|Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 2 - 5 and 287 on Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, and 6 and 285 on Days 3, 4, and 7.||Scores on a scale||Standard Deviation|Mean
43218|NCT01413516|Secondary|Stage of Change||4 weeks||12/2016||||
43219|NCT01413516|Secondary|Time to First Cigarette Post-hospitalization||4 weeks||12/2016||||
43220|NCT01413516|Secondary|Medication Compliance Rate|This will be measured using two biomarkers collected from blood, urine, and saliva samples.|4 weeks after initial assessment||12/2016||||
43200|NCT01413958|Secondary|Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
43201|NCT01413958|Secondary|Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Day 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and at Day 7 was 285.||Scores on a scale||Standard Deviation|Mean
43202|NCT01413958|Secondary|Time to Maximal Phenylephrine Effect|The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group.|Baseline up to Day 7|All participants in the intent-to-treat population (all randomized participants who received at least 1 tablet of study medication).||Days|||Number
43203|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Day 2 - 7. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6 and 285 on Day 7.||Scores on a scale||Standard Deviation|Mean
43204|NCT01413958|Secondary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Days 2 - 7. For Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6, and 285 on Day 7.||Scores on a scale||Standard Deviation|Mean
43205|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
43206|NCT01413958|Secondary|Mean Change From Baseline in the Evening Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
43207|NCT01413958|Secondary|Mean Change From Baseline in the Morning Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
43208|NCT01413958|Primary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.||Scores on a scale||Standard Deviation|Mean
43209|NCT01413750|Secondary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose in which 33% or more of the patients experience a DLT. The MTD is based on the first cycle of therapy. The recommended Phase II dose is generally the MTD, although secondary considerations of toxicity and dose reductions on subsequent cycles and other secondary considerations may result in the recommended Phase II dose being below the MTD.|4 weeks from start of treatment, up to 1 year|||mg|||Number
43210|NCT01413750|Secondary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III or higher non-hematological toxicity except nausea, vomiting or alopecia. Nausea or vomiting (> grade 2) that last longer than 48 hours despite maximal medical therapy. Absolute neutrophil count < 1000/uL lasting longer than 7 days. Grade 4 thrombocytopenia (platelet < 25,000/uL). Grade 3 or 4 neutropenia associated with sepsis or fever > 38 C. Delay in starting cycle 2 by more than 2 weeks due to toxicity.Abnormal non-hematological laboratory criteria (Grade 3 or higher) will be considered a DLT, if clinically significant and drug-related. If baseline value is elevated prior to drug therapy, an increase will not be considered a DLT unless there is an elevation by more than 2 grades, and it is of clinical significance. Dose escalation schedule for vorinostat: 600 mg QD; 800 mg QD.|4 weeks from start of treatment, up to 1 year|||participants with DLTs|||Number
43211|NCT01413750|Primary|Progression-free Survival (PFS)|"Estimated using the product-limit method of Kaplan and Meier.~PFS defined as time from randomization to progression or death due to any cause.~Progression defined as Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year|Due to early termination phase II portion of the study did not reach planned accrual.||months||95% Confidence Interval|Median
43212|NCT01413542|Secondary|Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion||Blood for analysis of GLP-1 levels was obtained one hour after sitagliptin (DPP4 inhibition) vs. placebo administration and after each dose of GLP-1|||pmol/L||Standard Error|Mean
43213|NCT01413542|Secondary|Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)||Blood for analysis of norepinephrine (NE) release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)|||pg/mL||Standard Error|Mean
43214|NCT01413542|Secondary|Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)||Heart rate was measured every 5 minutes throughout the study day (and thus during each dose of peptide infusion)|||beats per minute||Standard Error|Mean
43215|NCT01413542|Secondary|Assess Tissue Type Plasminogen Activator (tPA) Release|Following measurement of FBF, samples will be obtained to determine the effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) (group 1)|Blood for analysis of tPA release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)|||estimate of difference (ng/min/100mL)||95% Confidence Interval|Number
43216|NCT01413542|Primary|The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).|Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined.|60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehicle|In Group 1: Peptide 1=Max dose Bradykinin; Peptide 2=Substance P (SP) In Group 2: Peptide 1=GLP-1; Peptide 2=BNP (FBF expressed as percent change for both peptides) ACE inhibition=enalaprilat DPP4 inhibition=sitagliptin||estimate of difference(ml/min/100ml FBF)||95% Confidence Interval|Mean
43217|NCT01413516|Secondary|Adverse Events|Adverse effects assessed by structured checklist with choices of not present, mild, moderate, severe graded by FDA toxicity criteria.|4 weeks||12/2016||||
43236|NCT01413191|Secondary|Disease Control Rate (i.e., the Proportion of Subjects With a Confirmed Complete or Partial Response of Any Duration or Stable Disease ≥3 Months in Duration)|The disease control rate will be presented and the adjusted 95% confidence interval will be calculated.|Up to 2 years||||||
43237|NCT01413191|Primary|Response Rate (% Participants With Complete or Partial Response)|Response rate is the percentage of subjects with a confirmed complete or partial response using revised Response Evaluation Criteria in Solid Tumors (RECIST) where changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria: Complete Response (CR): Disappearance all target lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): 30% or > decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): 20% or > increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study); and sum must demonstrate absolute increase of 5+ mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.|Baseline to 2 years|One participant was not evaluable for response assessment.||participants|||Number
43238|NCT01412957|Secondary|Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).|Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)|QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment.||msec||Standard Deviation|Mean
43239|NCT01412957|Secondary|Number of Participants With Adverse Events (AEs)|The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.|From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.|Safety Analysis Set (all randomized participants)||participants|||Number
43240|NCT01412957|Secondary|Objective Response Rate in Participants With Wild-type RAS|Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set||percentage of participants||95% Confidence Interval|Number
43241|NCT01412957|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT analysis set||percentage of participants||95% Confidence Interval|Number
43242|NCT01412957|Secondary|Progression Free Survival (PFS) in Participants With Wild-type RAS|"PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death.~Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date."|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set||months||95% Confidence Interval|Median
43425|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
43243|NCT01412957|Secondary|Overall Survival in Participants With Wild-type RAS|A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS)||months||95% Confidence Interval|Median
43244|NCT01412957|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT Analysis Set||months||95% Confidence Interval|Median
43245|NCT01412957|Primary|Overall Survival|Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol.||months||95% Confidence Interval|Median
43246|NCT01412944|Secondary|Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy|This outcome measure was not analyzed due to the small sample size of the study (43 participants).|End of study||||||
43247|NCT01412944|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant’s ability to respond to secukinumab treatment.|Baseline, weeks 12, 24 and 40|Participants from full analysis set (FAS), who had values at baseline and post-baseline, were included in the analysis. The FAS included all participants to whom treatment was assigned.||Number of participants|||Number
43248|NCT01412944|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.||Percent change||Standard Deviation|Mean
43249|NCT01412944|Secondary|Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percent change||Standard Deviation|Mean
43250|NCT01412944|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percentage of participants|||Number
43426|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
43251|NCT01412944|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percentage of participants|||Number
43252|NCT01412944|Secondary|Mean Percent Change From Baseline in PASI Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.||Percent change||Standard Deviation|Mean
43253|NCT01412944|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.||Percentage of participants|||Number
43254|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.||Percentage of participants|||Number
43255|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.||Percentage of participants|||Number
43256|NCT01412918|Secondary|Percentage of Participants Which Showed Presence of SCN9 Gene Expression.|Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.|Single visit (day 1), evaluated at the time of the genetic collection.|||% of participants with gene expression|||Number
43257|NCT01412918|Primary|Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception|Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.|Single visit (day 1), assessed the day of visit|||percentage of participants|||Number
43258|NCT01412801|Primary|Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.|The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).||Ratios||95% Confidence Interval|Geometric Mean
43259|NCT01412801|Secondary|Percentages of Infants Who Experienced Unsolicited Adverse Events|Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination|Birth to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Infants)||percentages of Infant subjects|||Number
43260|NCT01412801|Secondary|Percentages of Subjects Who Experienced Unsolicited Adverse Events|Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine|Day 1 to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Maternal Subjects)||percentages of subjects|||Number
43261|NCT01412801|Secondary|Percentages of Subjects With Solicited Systemic AEs|Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)||percentages of Subjects|||Number
43262|NCT01412801|Secondary|Percentages of Subjects With Solicited Local Adverse Events (AEs)|Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)||percentage of Subjects|||Number
43263|NCT01412801|Secondary|Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery|Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.|Day of Delivery|FAS (Maternal Subjects)||Percentage of maternal subjects|||Number
43264|NCT01412801|Secondary|Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery|Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.|Day 1, 15, 31 and at Delivery|FAS (Maternal Subjects in the Exposed Population) who -Secondary objective serum GMC: provided at least one evaluable sample result at day 1 (prior to vaccination), day 15, day 31, or at delivery;- Secondary objective kinetics: provided at least one evaluable serum sample at day 1 (prior to vaccination), day 15, day 31, and at delivery.||µg/mL||95% Confidence Interval|Geometric Mean
43265|NCT01412801|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth|GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).||μg/mL||95% Confidence Interval|Geometric Mean
43266|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 12 Months.|Percentage of subjects with Readmission for cardiovascular events at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43267|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 6 Months.|Percentage of subjects with Readmission for cardiovascular events at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43268|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 1 Month.|Percentage of subjects with Readmission for cardiovascular events at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43269|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 12 Months.|Percentage of subjects with Major vascular complications at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43270|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 6 Months.|Percentage of subjects with Major vascular complications at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43271|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 1 Month.|Percentage of subjects with Major vascular complications at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43272|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 12 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43273|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 6 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43274|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1 Month.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43275|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 12 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43276|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 6 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43277|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 1 Month.|Percentage of subjects with Target Vessel Revascularization (TVR) at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43278|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 12 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participans||95% Confidence Interval|Number
43279|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 6 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of partiipants||95% Confidence Interval|Number
43280|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 1 Month.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43281|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 12 Months.|Percentage of subjects with All-cause death at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43282|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 6 Months.|Percentage of subjects with All-cause death at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43283|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 1 Month.|Percentage of subjects with All-cause death at 1 Month|1 month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43284|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 6 Months: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 6 months: index limb amputation, index limb re-intervention, and index-limb-related death.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of Participants||95% Confidence Interval|Number
43285|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 1 Month: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 1 Month.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 1 Month: index limb amputation, index limb re-intervention, and index-limb-related death at 1 month.|1 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of Participants||95% Confidence Interval|Number
43286|NCT01412541|Secondary|Secondary Safety #1 - Percentage of Subjects With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint).|Percentage of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)|30 days|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43287|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical Component and Mental Component of SF-36 v2 From Baseline to 12 Months.|Mean change in quality of life physical component and mental component of SF-36 v2 from baseline to 12 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
43288|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical and Mental Component of SF-36 v2 From Baseline to 6 Months.|Mean change in quality of life physical and mental component of SF-36 v2 from baseline to 6 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
43289|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 12 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 12 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
43290|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 6 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 6 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
43291|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline Through 12 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline through 12 months|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||meters||Standard Deviation|Mean
43292|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline to 6 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline to 6 months|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||meters||Standard Deviation|Mean
43293|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 12 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 12 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
43346|NCT01411852|Secondary|Ventilator Free Days Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of the 911 call through Day 28|Patients with known discharge status.||Ventilator-free days||Standard Deviation|Mean
43294|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 6 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 6 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 6 months|The sample size were subjects that had data available for analysis of the endpoint.||units on a scale||Standard Deviation|Mean
43295|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 12 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 12 months of resting ankle brachial index (ABI).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||ratio||Standard Deviation|Mean
43296|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 6 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 6 months of resting ankle brachial index (ABI).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||ratio||Standard Deviation|Mean
43297|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 12 Months.|Percentage of subjects with change of Rutherford classification from baseline to 12 months Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants improving|||Number
43298|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 6 Months (%Improved).|"Percentage of subjects with change of Rutherford classification from baseline to 6 months (%Improved).~Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain"|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants improving|||Number
43299|NCT01412541|Other Pre-specified|Sectondary Safety #9|Percentage of subjects with Target limb related hospital days|1 and 2 years||10/2016||||
43300|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 12 Months|12 Month|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43301|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 6 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43302|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of partcipants||95% Confidence Interval|Number
43303|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subject With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6 Months.|Percentage of subject with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43304|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.5 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.5 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43305|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Suplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <2.5 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Suplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <2.5 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43306|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <3.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <3.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43307|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <3.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <3.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43308|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43309|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound Peak Systolic Velocity Ratio (DUS PSVR) <2.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound peak systolic velocity ratio (DUS PSVR) <2.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|.The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43310|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency Rate at 12 Months (Defined by Core Lab Adjudication).|Percentage of subjects with Secondary Patency Rate at 12 Months (defined by core lab adjudication)|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43311|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency (Absence of Target Lesion Restenosis by Core Lab Adjudication) at 6 Months.|Percentage of subjects with Secondary Patency (absence of target lesion restenosis by core lab adjudication) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of Participants||95% Confidence Interval|Number
43312|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 12 Months.|Percentage of subjects with duplex ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 12 months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43313|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 6 Months.|Percentage of subjects with Duplex Ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 6 months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.||percentage of participants||95% Confidence Interval|Number
43314|NCT01412541|Secondary|Secondary Efficacy #1B - Number of Subjects With Procedural Success.|Number of subjects with Procedural Success defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.|During the procedure|Based on number of subjects with Procedural success as identified by the core lab.||participants|||Number
43315|NCT01412541|Secondary|Secondary Efficacy #1A - Number of Subjects With Technical Success.|Number of subjects with Technical Success defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent.|During the procedure|Based on number of subjects with Technical success as identified by the core lab.||participants|||Number
43316|NCT01412541|Secondary|Secondary Efficacy #1 - Number of Devices With Device Success.|Number of devices with Device Success defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.|During the procedure|Based upon devices used in the study (432 for DCB and 180 for PTA).||devices|Participants||Number
43317|NCT01412541|Primary|Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year.|Percentage of subjects with Primary patency of the target lesion at one year. Primary patency is defined as freedom from target lesion restenosis (defined by duplex ultrasound core lab adjudication) and target lesion revascularization (TLR).|12 months|Overall, 83.5% (264/316) test DCB subjects and 84.4% (135/160) control PTA subjects were evaluable for the primary efficacy endpoint testing.||percentage of participants||95% Confidence Interval|Number
43318|NCT01412541|Primary|Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative (≤30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 12 Months.|Percentage of subjects with Composite of freedom from all-cause peri-operative (≤30 day) death and freedom from the following: index limb amputation, index limb re-intervention, and index-limb-related death at 12 months.|12 months|Overall, 90.5% (286/316) test DCB subjects and 89.4% (143/160) control PTA subjects were evaluable for primary safety endpoint testing.||percentage of participants||95% Confidence Interval|Number
43319|NCT01412424|Secondary|Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period|Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants|||Number
43320|NCT01412424|Secondary|Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period|The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants||95% Confidence Interval|Number
43321|NCT01412424|Secondary|Maintenance of Response During the Extension Treatment Period|Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration < 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants||95% Confidence Interval|Number
43322|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 < 1.3 times the upper level of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Beginning and the end of the extension treatment period (up to 6 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of participants|||Number
43323|NCT01412424|Secondary|Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period|Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)|Fixed dose population: All enrolled participants who received any amount of study drug, who had at least 1 IGF-1 or GH assessment after the first dose of octreotide, and who entered the fixed dose phase of the core treatment period.||Percentage of participants|||Number
43324|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 < 1.3 times the upper limit of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Baseline and the end of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.||Percentage of participants|||Number
43325|NCT01412424|Primary|Percentage of Responders at the End of the Extension Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.||Percentage of responders||95% Confidence Interval|Number
43326|NCT01412424|Primary|Percentage of Responders at the End of the Core Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.||Percentage of responders||95% Confidence Interval|Number
43327|NCT01412281|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects||participants|||Number
43328|NCT01412281|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage of seroconverted subjects||95% Confidence Interval|Number
43427|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
43329|NCT01412281|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||percentage of seroprotected subjects||95% Confidence Interval|Number
43330|NCT01412281|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase from baseline||95% Confidence Interval|Number
43331|NCT01412164|Secondary|Stent Implantation Success Rate|30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis|5 years||||||
43332|NCT01412164|Primary|Device Related Cardiovascular Composite Endpoint|Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure|12 months|||participants|||Number
43333|NCT01412151|Secondary|Biological Markers of Disease Progression|Biological indicators that creatine treatment might affect the progression of HD: serum creatine levels, neuroimaging, metabolomic and gene expression analysis|310 Weeks||||||
43334|NCT01412151|Secondary|Clinical Measures|Components of the UHDRS (Unified Huntington Disease Rating Scale)|310 Weeks||||||
43335|NCT01412151|Primary|Tolerability|Proportion of subjects able to complete treatment|306 Weeks|||Participants|||Number
43336|NCT01412086|Primary|Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.||Kappa statistics||95% Confidence Interval|Number
43337|NCT01412086|Primary|Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters scored 112 subjects’ eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kendall’s W was provided.|Day 1|||Kendall's W||95% Confidence Interval|Number
43338|NCT01411891|Primary|Femoral Nerve Catheter Bacterial Colonization|Describes rate of femoral nerve catheter bacterial colonization.|Colonization measured following catheter removal (approximately 48 hours after placement).|Patients presenting for elective TKA.||participants|||Number
43339|NCT01411891|Secondary|Catheter Insertion Site Colonization.|Skin at the FNC insertion site will be swabbed with a sterile cotton tip applicator moistened with sterile normal saline. The swab will be placed in a sterile container. The swab will be inoculated onto a blood agar plate/eosin-methylene blue plate/chocolate agar plate and incubated for 3 days aerobically, then inoculated onto an anaerobic brucella-agar plate and incubated for 7 days anaerobically. Bacterial growth found in the first quadrant of the inoculated plate will be defined as low grade, in the second and/or third will be moderate, and in the fourth quadrant will be heavy.|24-48 hours.||||||
43340|NCT01411891|Primary|Catheter Tip Colonization|Three cm of the for research purposes only, a 3 cm distal portion will be cut using sterile scissors into a sterile container, and sent to the lab for culture in a sterile container. The catheter segments will be rolled onto blood agar plates at 35°C under aerobic and anaerobic conditions. Number of colonies will be counted at 1 week. The peripheral nerve catheter tip will be considered colonized if the culture yields 15 or greater colony forming units.|24-48 hours after placement of femoral nerve catheter.||||||
43341|NCT01411852|Secondary|In-hospital Mortality|Number of patients who died prior to discharge.|From day of the 911 call through hospital discharge|All enrolled patients||participants|||Number
43342|NCT01411852|Secondary|Penetrating Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by penetrating mechanisms in each arm.|From time of hospital arrival through first 24 hours|Patients with traumatic shock due to penetrating traumatic mechanisms||participants|||Number
43343|NCT01411852|Secondary|Blunt Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by blunt mechanisms in each arm.|From time of hospital arrival through first 24 hours|Analyzed patients had traumatic shock due to blunt traumatic mechanisms. One patient randomized to the controlled resuscitation group was not analyzed because neither blunt force nor penetrating injury had occurred. It was determined that the source of bleeding was from a gastrointestinal lesion.||participants|||Number
43344|NCT01411852|Secondary|Days Alive Out of the Hospital Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the hospital"|From day of the 911 call through Day 28|Patients with known discharge status||Days alive out of hospital thru day 28||Standard Deviation|Mean
43345|NCT01411852|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the intensive care unit"|From day of the 911 call through Day 28|Patients with known discharge status||ICU-free days||Standard Deviation|Mean
43347|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Failure Without Glomerular Filtration Rate (GFR)"|Increased plasma creatinine > 3 x reference measure (ED admission) or acute plasma creatinine = 350 umol/L or acute rise = 44 umol/L or urine output < 0.3 mL/k/h x 24h. Only measured for patients with at least 2 days of ICU stay assessed.|From ED arrival through the first 24 hours|Patients with at least at 2 day stay in the ICU||participants|||Number
43348|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Injury Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 2 x reference measure (ED admission) or urine output < 0.5 mL/kg/h x 24h. The RIFLE urine criterion for this level actually specifies a 12 hour period of assessment but study data are collected for 24-hr periods. This row includes patients who met the Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least at 2 day stay in the ICU||participants|||Number
43349|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Risk Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 1.5 x reference measure (ED admission). Urine criteria is based on 6-hour periods for this level of the RIFLE and cannot be assessed since study data are collected for 24-hour periods. This row includes patients who met the Injury and Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least a 2 day ICU stay||participants|||Number
43350|NCT01411852|Secondary|Hemorrhage Control Procedure Within 2 Hours of ED Arrival|Hemorrhage control procedures include blood vessel ligated or embolized, organ packed or removed, laparotomy or thoracotomy|From ED arrival through the first 2 hours|All patients except for 1 patient who was enrolled while in police custody||participants|||Number
43351|NCT01411852|Secondary|International Normalized Ratio (INR) on Admission to the Emergency Department|The first International normalized ratio (INR) value reported from blood drawn within the first 24 hours from arrival|From final Emergency Department arrival time through first 24 hours|Patients who had a first INR value measured within the first 24 hours of ED arrival||ratio||Standard Deviation|Mean
43352|NCT01411852|Secondary|Platelet Value on Admission|First platelet value from blood drawn in the the first 24 hours after arrival|From final Emergency Department arrival time through first 24 hours|All patients with the first platelet value measured within the first 24 hours of ED arrival||10^9 Platelets/Liters||Standard Deviation|Mean
43353|NCT01411852|Secondary|Hemoglobin on Admission to the Emergency Department|The first hemoglobin value reported from blood drawn in the final Emergency Department|From final Emergency Department arrival time through first 24 hours|All patients with a first hemoglobin measured within the first 24 hours of ED arrival||grams/deciliter||Standard Deviation|Mean
43354|NCT01411852|Secondary|Base Deficit on Admission to the Emergency Department (ED)|The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal.|From final Emergency Department arrival time through first 24 hours|Patient with the first base deficit recorded in the first 24 hours of the ED arrival||mmol/Liter||Standard Deviation|Mean
43355|NCT01411852|Secondary|Total Blood Product Requirements in First 24 Hours|Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo)|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody||Liters||Standard Deviation|Mean
43356|NCT01411852|Secondary|Total Fluid Requirement During First 24 Hours|Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody||Liters||Standard Deviation|Mean
43357|NCT01411852|Secondary|Number of Ineligible Patients Enrolled at the Time of Randomization|"Eligibility criteria:~Inclusion Criteria~Included will be those with:~Blunt or penetrating injury~Age ≥15yrs or weight ≥50kg if age is unknown~Prehospital SBP ≤ 90 mmHg 5.3 Exclusion Criteria~Excluded will be those with:~Ground level falls~Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8~Bilateral paralysis secondary to suspected spinal cord injury~Fluid greater than 250 ml was given prior to randomization~Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization~Known prisoners~Known or suspected pregnancy~Drowning or asphyxia due to hanging~Burns Total Body Surface Area (TBSA) > 20%~Time of call received at dispatch to study intervention > 4 hours"|From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival|All patients enrolled in the study.||participants|||Number
43358|NCT01411852|Primary|24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients each arm|From time of hospital arrival through the first 24 hours|All patients except for one who was enrolled while in police custody||participants|||Number
43359|NCT01411852|Primary|Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility)|The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period|From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first|Patients with traumatic shock due to blunt or penetrating mechanisms||liters||95% Confidence Interval|Mean
43360|NCT01411696|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.|Baseline, 4 to 20 Weeks after Each injection (up to 6 months)|All participants with data available for analysis.||Micron (μm)||Standard Deviation|Mean
43361|NCT01411696|Secondary|Percentage of Participants With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.||Percentage of participants|||Number
43362|NCT01411696|Secondary|Percentage of Participants With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.||Percentage of participants|||Number
43363|NCT01411696|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 4 to 20 weeks after last injection (Up to 6 months)|All participants with data available for analysis.||Lines||Full Range|Mean
43364|NCT01411592|Secondary|Debonding of the RBFDP|Restoration was rebonded without any impairment of function|5 years|||participants|||Number
43365|NCT01411592|Primary|Final Loss of the Restauration||5 years|||participants|||Number
43366|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 8th Week|"This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3.~0—Without difficulty~Defecation straining~Severe defecation straining~Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.~[the average score of one week at the 8th week]-[the average score of one week at baseline]"|baseline and at 8 weeks|||participants|||Number
43367|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 8th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.|baseline and at 8 weeks|||units on a scale||Full Range|Mean
43368|NCT01411501|Secondary|Changes of the SBMs From Baseline at Week 8|[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 8 weeks|||times per week||95% Confidence Interval|Mean
43369|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 4th Week|"This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3.~0—Without difficulty~Defecation straining~Severe defecation straining~Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.~[the average score of one week at the 4th week]-[the average score of one week at baseline]"|baseline and at 4 weeks|||participants|||Number
43370|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 4th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.|baseline and at 4 weeks|||units on a scale||95% Confidence Interval|Mean
43371|NCT01411501|Primary|Change of the SBMs From Baseline at Week 4|[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 4 weeks|||times per week||95% Confidence Interval|Mean
43372|NCT01411228|Secondary|Liver Volume|Liver volume by MRI or Ultrasound. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||Milliliters||Standard Error|Mean
43373|NCT01411228|Secondary|Platelet Count|Platelet count. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12, 24 and 33-36|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||Platelets/mm^3||Standard Error|Mean
43374|NCT01411228|Secondary|Spleen Volume|Spleen volume measured by MRI (or ultrasound). Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||Milliliters||Standard Error|Mean
43375|NCT01411228|Secondary|Chitotriosidase|Chitotriosidase. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Chitotriosidase was not analyzed for the subjects in the Switchover group||nmol/mL*h||Standard Deviation|Mean
43376|NCT01411228|Primary|Hemoglobin|Median and interquartile range. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program||g/dL||Inter-Quartile Range|Median
43377|NCT01411215|Secondary|Number of RA Participants Had Remission of Disease|Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.||Participants|||Number
43378|NCT01411215|Secondary|Number of RA Participants Had DAS28-4 (ESR) Improvement|Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2.|Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR) improvement. n=number of evaluable participants at the corresponding visit.||Participants|||Number
43423|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
43379|NCT01411215|Secondary|Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity.|Baseline (Week 0), Week 2, Week 4, Week 12, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.||units on a scale||Standard Deviation|Mean
43380|NCT01411215|Secondary|Swollen Joint Count (SJC) for RA Participants|SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for SJC. n=number of evaluable participants at the corresponding visit.||Joints||Standard Deviation|Mean
43381|NCT01411215|Secondary|Tender Joint Count (TJC) for RA Participants|TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for TJC. n=number of evaluable participants at the corresponding visit.||Joints||Standard Deviation|Mean
43382|NCT01411215|Secondary|Number of Participants With Any Abnormal Laboratory Test Results|Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN).|Baseline (Week 0) up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for laboratory test abnormalities.||Participants|||Number
43383|NCT01411215|Secondary|Evaluate the Association Between Participant's Age and Treatment Adherence Rate|Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded. n=number of evaluable participants at the corresponding age group.||Participants|||Number
43384|NCT01411215|Secondary|Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%|Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded.||Participants|||Number
43385|NCT01411215|Secondary|VAS Score for Pain|Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for pain. n=number of evaluable participants at the corresponding visit.||mm||Standard Deviation|Mean
43386|NCT01411215|Secondary|Participant’s Global Assessment (PtGA) of Disease Activity|Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for PtGA of disease activity. n=number of evaluable participants at the corresponding visit.||mm||Standard Deviation|Mean
43387|NCT01411215|Secondary|Physician’s Global Assessment of Disease Activity|Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant’s disease according to the participant’s clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for physician’s global assessment of disease activity. n=number of evaluable participants at the corresponding visit.||mm||Standard Deviation|Mean
43388|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
43389|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
43390|NCT01411215|Primary|Number of Participants Who Had Any SAEs During 52 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
43391|NCT01411215|Primary|Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
43392|NCT01411215|Primary|Number of Participants Who Had Any AEs During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
43393|NCT01411215|Primary|Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.||Participants|||Number
43394|NCT01410773|Secondary|Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the YSI capillary plasma reference method results.|1 hour|One subject had low blood sugar. The protocol (and User Guide) do not allow alternative site testing when blood sugar is low. The remaining 109 subjects tested one strip lot on the BGM system. 109 test results were available.||participants|||Number
43395|NCT01410773|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|110 subjects tested one of 3 test strip lots on the BGM system. 110 (1x110) test results are available.||participants|||Number
43396|NCT01410604|Secondary|Waist Circumference|Change from baseline in Waist circumference after 3 months of treatment.|baseline and 3 months|||cm||Standard Deviation|Mean
43397|NCT01410604|Secondary|Body Mass Index|Change from baseline in Body Mass Index after 3 months of treatment.|baseline and 3 months|||kg/m^2||Standard Deviation|Mean
43398|NCT01410604|Secondary|Fasting Insulin|Change from baseline in Fasting insulin after 3 months of treatment.|baseline and 3 months|||µU/mL||Standard Deviation|Mean
43399|NCT01410604|Secondary|Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose after 3 months of treatment.|baseline and 3 months|||mg/dL||Standard Deviation|Mean
43400|NCT01410604|Primary|Tumour Necrosis Factor Alpha|Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.|baseline and 3 months|||pg/mL||Standard Deviation|Mean
43401|NCT01410604|Primary|Interleukin 6|Change from baseline in Interleukin 6 after 3 months of treatment.|baseline and 3 months|||pg/mL||Standard Deviation|Mean
43402|NCT01410604|Primary|High-sensitivity C-reactive Protein|Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.|baseline and 3 months|||mg/dL||Standard Deviation|Mean
43403|NCT01410604|Primary|Adiponectin|Change from baseline in Adiponectin after 3 months of treatment.|baseline and 3 months|||µg/mL||Standard Deviation|Mean
43404|NCT01410565|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.|24 Months from Randomization|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.||participants|||Number
43405|NCT01410565|Secondary|Recurrence Rate at 24 Months|Measurement the number of participants with the recurrence at 24 months.|24 months|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.||participants|||Number
43406|NCT01410565|Primary|Time to Recurrence|Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).|Recurrence of cancer in the bladder during 24 months of follow-up|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase. Participants without recurrence were censored.||months||Full Range|Mean
43407|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years|Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population.||Subjects|||Number
43408|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years|Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.||Subjects|||Number
43409|NCT01410474|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.|Day 1 and 29|Analysis was done on MITT population||Percentages of Subjects||95% Confidence Interval|Number
43410|NCT01410474|Secondary|Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and Day 29|Analysis was done on MITT population||Ratio||95% Confidence Interval|Geometric Mean
43411|NCT01410474|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and 29|Analysis was done on MITT population||hSBA Titers||95% Confidence Interval|Geometric Mean
43412|NCT01410474|Secondary|Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups.~Seroresponse is defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on MITT population||Percentages of Subjects||95% Confidence Interval|Number
43413|NCT01410474|Primary|Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29).~Seroresponse is defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.||Percentages of Subjects||95% Confidence Interval|Number
43414|NCT01410409|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.~Number of sites with pain in the previous 24 hours shaded on a region-divided body chart~Pain location and type assessed using the Knee Pain Map.~Maximum isometric muscle strength (converted to Nm using the length of the lower leg) measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander from JTech Medical Industries, Salt Lake City, Utah, USA)~Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at five sites at the knee and the m. tibialis anterior muscle.~Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.~Further exploratory objectives may be added later on."|Baseline, 3months, 6months, 12months and 24 months.|Will be reported in later publications, as it is exploratory outcomes|||||
43415|NCT01410409|Secondary|Serious Adverse Events Related to the Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants|Primary: 12months|||Serious adverse events related to knee|||Number
43416|NCT01410409|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.|||proportion of participants||95% Confidence Interval|Number
43417|NCT01410409|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in the analysis||kg||95% Confidence Interval|Mean
43418|NCT01410409|Secondary|Change in the Five Subscales of KOOS From Baseline|All subscales going from 0 to 100 (worst to best)|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
43419|NCT01410409|Secondary|Change in 20-meter Walk From Baseline||Primary: 12months.|||sec||95% Confidence Interval|Mean
43420|NCT01410409|Secondary|Change in Timed Up & Go (TUG) From Baseline||Primary: 12months.|||sec||95% Confidence Interval|Mean
43421|NCT01410409|Secondary|Change in EQ-5D From Baseline|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description (Links)~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
43422|NCT01410409|Primary|Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)|The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.|Primary: 12months.|||units on a scale||95% Confidence Interval|Mean
43429|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
43430|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set||participants|||Number
43431|NCT01410240|Secondary|Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
43432|NCT01410240|Secondary|Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
43433|NCT01410240|Secondary|Proportion of Participants With Transfusion Requirements||Intra-operative|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
43434|NCT01410240|Secondary|Length of Hospital Stay||From the day of hospitalization to the day of discharge|Full Analysis Set||Days||Standard Deviation|Mean
43435|NCT01410240|Primary|Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)|"Proportion of Participants who have serious injuries (SIs) related to IP~Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP"|Throughout the study period, 1 year and 4 months|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"||Proportion of participants||95% Confidence Interval|Number
43436|NCT01410240|Secondary|Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6|"Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.~Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) – (Baseline Scores)."|Baseline and Postoperative Weeks 1, 2, and 6|||Scores on a scale||Standard Deviation|Mean
43437|NCT01410240|Secondary|Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.|Preoperative, and Postoperative Weeks 1, 2, and 6|Full Analysis Set||Scores on a scale||Standard Deviation|Mean
43438|NCT01410240|Secondary|Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores|"A well-validated scale to reflect problems in people with lower limb issues.~Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)~Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)~Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).~Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues).~Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
43439|NCT01410240|Secondary|Western Ontario and McMaster Universities (WOMAC) Function Index Scores|"A well-validated scale to reflect problems in people with lower limb issues.~Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)~Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)~Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD)~Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).~Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues)~Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
43440|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
43441|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2|Full Analysis Set||score on a scale||Standard Deviation|Mean
43442|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1|Full Analysis Set||score on a scale||Standard Deviation|Mean
43443|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3|Full Analysis Set||score on a scale||Standard Deviation|Mean
43444|NCT01410240|Secondary|Visual Analogue Scale (VAS) Pain Scores|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6|Full Analysis Set||score on a scale||Standard Deviation|Mean
43445|NCT01410240|Secondary|Pain Management - Number of Days When Pain Medication Was Used|"Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis.~While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary."|Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6|Full Analysis Set||days||Standard Deviation|Mean
43446|NCT01410240|Secondary|Total Drain Output at Day 1 Post-operatively||1 day post-operatively|Full Analysis Set||mL||Standard Deviation|Mean
43447|NCT01410240|Secondary|Transfusion Requirements - Packed Red Blood Cells||Intra-operatively (Day 0) thru Postoperative Day 3|Full Analysis Set - participants with transfusion requirement||mL||Standard Deviation|Mean
43448|NCT01410240|Secondary|Duration of Surgery||Time from first incision to complete wound closure (Day 0)|Full Analysis Set||minutes||Standard Deviation|Mean
43449|NCT01410240|Secondary|Amount of FLOSEAL Applied||Intra-operatively (Day 0)|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 15 Run-In participants"||mL||Standard Deviation|Mean
43450|NCT01410240|Secondary|Total Tourniquet Time|Measured from the time point of the tourniquet inflation to deflation using the same watch/clock|Intra-operatively (on day of surgery = Day 0)|Full Analysis Set||minutes||Standard Deviation|Mean
43451|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 3||Pre-operative and day 3 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."||percent||Standard Deviation|Mean
43452|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 2||Pre-operative and day 2 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."||percent||Standard Deviation|Mean
43453|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 1|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.|Pre-operative and day 1 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."||percent||Standard Deviation|Mean
43454|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.|Pre-operative and day 3 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."||g/dL||Standard Deviation|Mean
43455|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively||Pre-operative and day 1 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."||g/dL||Standard Deviation|Mean
43456|NCT01410240|Primary|Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively||Pre-operative and 2 days post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the primary outcome assessment of Hgb level at postoperative Day 2 were excluded from the primary outcome analysis."||g/dL||Standard Deviation|Mean
43457|NCT01410227|Secondary|PK80- Ratio of Intra-participant PK of VWF:RCo, VWF:Ag and VWF:CB at Baseline and After 6 Months|Area under the plasma concentration curve (AUC) from time 0 to infinity per dose (AUC0-∞/dose) for von Willebrand Factor Ristocetin cofactor (VWF:RCo), von Willebrand Factor Antigen (VWF:Ag) and von Willebrand Factor Collagen Binding (VWF:CB). Each parameter was compared between the two PK assessments after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. 13 participants had data available for this endpoint i.e. data for PK1 and PK2.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|Participants from the PK80 Arm who had pharmacokinetic (PK) data available after both the first infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] [PK1] and the second infusion of 80 IU/kg rVWF [PK2].||ratio of AUC0-∞/dose||90% Confidence Interval|Geometric Mean
43458|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43530|NCT01410110|Primary|Days of Use in Prior 30 Days|Days of Use based on Time-Line Follow-back, Toxicology Screen, Breathalyzer, and Chart Review. The range at 6 month follow-up is 0 to 30 days of use with more days being a worse outcome.|30 Days Prior to 6 month follow-up|||Days of Use||Standard Deviation|Mean
43459|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43460|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
43461|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43462|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43463|NCT01410227|Secondary|PK80 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
43464|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43465|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participatns from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43514|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to rFurin|The presence of total binding anti-rFurin antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against rFurin protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
43466|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43467|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
43468|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43469|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43470|NCT01410227|Secondary|PK80 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
43471|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43472|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43515|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to CHO|The presence of total binding anti-CHO antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against Chinese Hamster Ovary (CHO) protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
43473|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43474|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study. PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
43475|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43476|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43477|NCT01410227|Secondary|PK80 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
43478|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43479|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43526|NCT01410110|Secondary|Verbal and Visual Working Memory|WAIS Digit Span and Wechsler Memory Scale (WMS) Spatial Span. T Scores are averaged. T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Month, 6 Months|||T Scores||Standard Deviation|Mean
43480|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43481|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of FVIII:C|Volume of Distribution at Steady State (Vss) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
43482|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of FVIII:C|Elimination Phase Half-Life (T1/2) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43483|NCT01410227|Secondary|PK50 - Incremental Recovery of FVIII:C|Incremental Recovery (IR) at the maximum plasma concentration of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43484|NCT01410227|Secondary|PK50 - Clearance of FVIII:C|Clearance (CL) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
43485|NCT01410227|Secondary|PK50 - Mean Residence Time of FVIII:C|Mean Residence Time (MRT) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43486|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43487|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43488|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants[N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
43489|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43490|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43491|NCT01410227|Secondary|PK50 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
43492|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43493|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43494|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43495|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
43496|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43527|NCT01410110|Secondary|Verbal and Visual Learning and Memory|Brief Visual-Spatial Memory Test (BVMT) and Hopkins Verbal Learning and Memory Test (HVLT). Total Score T Scores for tests were averaged. T score range is 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
43497|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43498|NCT01410227|Secondary|PK50 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
43499|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43500|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43501|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43502|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg||95% Confidence Interval|Median
43503|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43504|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43528|NCT01410110|Secondary|Processing Speed Index|Wechsler Adult Intelligence Scale (WAIS) Digit Coding and Symbol Search. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
43505|NCT01410227|Secondary|PK50 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||dL/kg/hours||95% Confidence Interval|Median
43506|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||hours||95% Confidence Interval|Median
43507|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43508|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for subjects in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
43509|NCT01410227|Secondary|Number of Adverse Events by Infusion Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) by infusion related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of Adverse Events|Participants||Number
43510|NCT01410227|Secondary|Number of Participants With Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Number of participants with Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of participants|||Number
43511|NCT01410227|Secondary|Number of Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS). Category title includes number of AEs [N] for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of Adverse Events|Participants||Number
43512|NCT01410227|Secondary|Percentage of Participants Who Had an Occurrence of Thrombotic Events||After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
43513|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to Mouse Immunoglobulin|The presence of total binding anti-Murine immunoglobulin (IgG) antibodies was determined using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
43529|NCT01410110|Primary|Weeks of Sobriety|0 to 26 Weeks. Higher number of Weeks is better.|26 weeks|1 additional participant in Work Therapy Only had missing data for this variable.||Weeks||Standard Deviation|Mean
43516|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to VWF|The presence of total binding anti-VWF antibodies was determined by an enzyme-linked immunosorbent assay (ELISA) employing polyclonal anti-human immunoglobulin (Ig) antibodies (IgG, IgM and IgA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
43517|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to VWF|Neutralizing antibodies (inhibitors) to Von Willebrand Factor Ristocetin cofactor (VWF:RCo), VWF collagen binding (VWF:CB) and VWF Factor VIII binding (VWF:FVIIIB) activities were measured using Nijmegen modification of the Bethesda assay. One Bethesda Unit (BU) is thereby defined as the amount of inhibitor that decreased the measured activity in the assays to 50% of that of the negative control samples. The assays were validated using human plasma samples from two type 3 VWD patients with low (1-2 BU/mL) and high (~10 BU/mL) titer inhibitors and plasma samples from non-human primates immunized with human rVWF (>100 BU/mL). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
43518|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to FVIII|Development of neutralizing antibodies (inhibitors) to factor VIII (FVIII) was assessed by the Nijmegen modification of the Bethesda assay. Positive FVIII inhibitor tests were defined as ≥ 0.4 Bethesda units/mL (BU/mL) by the Nijmegen-modified Bethesda assay that is confirmed by a second test performed on an independent sample obtained 2-4 weeks following the first test. Category title includes number of participants [N] who provided data for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants|||Number
43519|NCT01410227|Secondary|Number of Units of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The number of units is provided as the actual dose [IU/kg] of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant’s PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product of known lot number with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||IU/kg|Participants|90% Confidence Interval|Median
43520|NCT01410227|Secondary|Number of Infusions of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The actual number of infusions of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant's PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Number of infusions|Participants|90% Confidence Interval|Median
43521|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good, Excluding Gastrointestinal Bleeds"|"Efficacy ratings of excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs excluding gastrointestinal (GI) bleeds treated with study product with an available efficacy rating from participants in the Full Analysis Set."|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of bleeding episodes|Participants|90% Confidence Interval|Geometric Mean
43522|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good"|"Efficacy ratings excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set"|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of bleeding episodes|Participants|90% Confidence Interval|Number
43523|NCT01410227|Primary|Percentage of Participants With Treatment Success for Treated Bleeding Episodes|Treatment success was defined as the extent of control of bleeding episodes (BEs) using a mean efficacy rating score of <2.5 for a participant’s BEs treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) during the study period. Scores used: Excellent = 1 - actual infusions ≤ estimated number of infusions required to treat BE; no additional VWF required (all BEs); Good = 2 - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); Moderate = 3 ≥ 3 infusions (minor/moderate BEs) or ≥ 1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); None = 4 - severe uncontrolled bleeding or intensity of bleeding not changed; additional VWF required. Included participants with available primary efficacy rating (prospective-excluding gastrointestinal bleeds) in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF|||Percent of participants||90% Confidence Interval|Number
43524|NCT01410110|Secondary|Global Index|Comprised of the average of 5 Index T Scores (Attention, Processing Speed, Visual and Verbal Memory and Learning, Working Memory and Executive Function). T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
43525|NCT01410110|Secondary|Executive Function|Mazes, Wisconsin Card Sorting Task (WCST) Perseverative Error, Non-Perseverative Error, Conceptual Level. T Scores for each variable were averaged together. T Scores have a range of 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months|||T Scores||Standard Deviation|Mean
43531|NCT01410110|Secondary|Attention Index|Index comprised on Trails A and Continuous Performance Test. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 month and 6 month follow-up|||T Scores||Standard Deviation|Mean
43532|NCT01410110|Primary|Days of Sobriety in First 90 Days|Abstinence will be determined by toxicology screening, breathalyzer and substance abuse calendar weekly during 3 months of active intervention. Days of sobriety has a range of 0 to 90 with higher being a better outcome.|3 months|||Days of Sobriety||Standard Deviation|Mean
43533|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|The proportion (per cent) of the total number of sperm cell with abnormal appearance.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.||Per cent||Standard Deviation|Geometric Mean
43534|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|The proportion (per cent) of the sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat||Per cent||Standard Deviation|Geometric Mean
43535|NCT01409837|Primary|Total Sperm Cell Count|The total number of sperm cells found in each milliliter of seminal fluid.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.||Millions/ml||Standard Deviation|Geometric Mean
43536|NCT01409837|Primary|Ejaculate Volume|The volume in milliliters of seminal fluid produced per ejaculation.|Week 282|All the patients who were randomized into eacg group was analyzed on the basis of intention-to-treat||ml||Standard Deviation|Geometric Mean
43537|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|Proportion (per cent) of sperm cells with abnormal appearance|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat.||per cent||Standard Deviation|Geometric Mean
43538|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|This was determined as the proportion (percent) of the total sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat||Per cent||Standard Deviation|Geometric Mean
43539|NCT01409837|Primary|Total Sperm Cell Count Per Milliliter of Seminal Fluid.|the number of sperm cells counted per milliliter volume of seminal fluid|Week 96|All the patients randomized into each group were analyzed on the basis of intention-to-treat||Millions/ml||Standard Deviation|Mean
43540|NCT01409837|Secondary|Adverse Events Monitoring|The patients were encouraged to report every event promptly by phone to one of the authors (NOG), no matter however minor.Blood pressure measurements were done with mercury sphygmomanometers fitted with adult-size cuffs (Accoson, England). Serum potassium levels were estimated using the flame photometric method as described by Davidson and Henry|At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282|All the patients who were randomized into each group were monitored for adverse events.||participants|||Number
43541|NCT01409837|Primary|Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study|The seminal fluid characteristics were assessed twice before the entry of each patient and both at least two-weeks apart. The two values were averaged and recorded as baseline for week 0 while subsequent changes from the baseline were monitored during each of the scheduled visits at weeks 6, 12, 24, 48, 96, 102, 114, 138, 186 and 282. The two groups swopped treatments at the 96th week. The number of pregnancies achieved was also documented throughout the study period.|Week 96.|All the patients randomized into each group were included in the analysis on the basis of intention-to-treat (last value carried forward)||ml||Standard Deviation|Geometric Mean
43542|NCT01409707|Primary|Timeline Follow Back|The timeline follow back is a measure of drug and alcohol consumption in the prior 90 days. The timeline follow back is a calendar-based retrospective account of drug and alcohol consumption for a specified period of time (e.g., past 90 days). One of the most commonly reported metrics of drug and alcohol consumption from this measure is percent days abstinent (PDA). Percent days abstinent is simply the proportion of days for the specified period of time (e.g., 90 days) in which drugs or alcohol were not consumed. Percent days abstinent can range from 0 to 100 with 0 representing no abstinence during a specified period of time (i.e., consumed alcohol every day) and 100 representing complete abstinence during a specified period of time.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.||percentage of days abstinent||Standard Error|Mean
43543|NCT01409707|Primary|Impact of Event Scale-Revised|The Impact of Event Scale-Revised is a 22-item self-report measure of posttraumatic stress disorder symptoms. The total score for the Impact of Event Scale-Revised ranges from 0 to 88 with lower scores representing less severe symptoms of posttraumatic stress disorder and higher scores representing more severe symptoms of posttraumatic stress disorder.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.||units on a scale||Standard Error|Mean
43544|NCT01408628|Secondary|Severity of Self-reported Hypoglycemia|Severity was defined by the scale used by the DCCT: grade 1 - subject was able to recognize and treat appropriately without assistance; grade 2 - subject required help from another person either to recognize or recognize/treat; grade 3 - subject required injection of glucagon or treatment in ER|6 Months|Subjects who completed both the Internet intervention and the 6 months of follow up||incidents (count)|||Number
43545|NCT01408628|Secondary|Change in HbA1c|Change in HbA1c (average measure of the % of glycosolated hemoglobin in the blood over the past 3 months) from baseline to end of follow up period.|Change from Baseline through Month 6 of follow-up period|Subjects who both completed the Internet intervention and the six months of follow up||percentage of glycosolated hemoglobin||Standard Deviation|Mean
43546|NCT01408628|Primary|Frequency of Hypoglycemia|Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject.|6-month follow up period following the Internet Intervention|Subjects who both completed the Internet intervention AND the 6 months of follow up||incidents per person-year||Standard Deviation|Mean
43547|NCT01408537|Secondary|Neutralizing Antibody Persistence One Year After the Primary Vaccination|To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.|1 year after primary vaccination|The analysis was excluded 5 subjects who had NT titer >10 on D0||participants|||Number
43548|NCT01408537|Secondary|Adverse Events of Vaccine|To determine the adverse events of JEVAC|7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively|Determined AEs by number of injections 152 injection for the first dose 151 injection for the second dose 145 injection for the third dose||events|Participants||Number
43549|NCT01408537|Secondary|Geometric Mean Titer of NT After Primary and Booster Vaccination|To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.|28 days after second vaccination, before and 28 days after booster vaccination with JEVAC|152 were enrolled, 1 withdrawn consent before second vaccine, 5 had NT >= 10 before first vaccine, 146 included in D28 after second vaccine. At 1 year, 3 received JE vaccine outside the study, 3 lost follow up, 140 included in before booster, At D28 after booster, 1 could not draw blood, 139 included in D28 after booster.||titer||95% Confidence Interval|Geometric Mean
43550|NCT01408537|Primary|Seroconversion Rate After Primary Vaccination|To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from <10 on before first vaccination To >= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer >=10 before first vaccination, will not be included in immunogenicity evaluation.|28 days after second dose of JEVAC|There were 152 enrolled subjects in the study. However, 5 subjects had NT titer >= 10 before first vaccination and one subject whom blood on 28days after second vaccination was not drawn due to withdrawn consent. Therefore, the number of subjects for the outcome measurement should be 146.||percentage of seroconversion|||Number
43551|NCT01408485|Secondary|Secondary Efficacy|Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.|3 months|||participants|||Number
43552|NCT01408485|Primary|Primary Efficacy|Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes|||participants|||Number
43553|NCT01408485|Primary|Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.||participants|||Number
43554|NCT01409564|Secondary|Fazekas Scale|"Level of severity of white matter lesions in AD patients who can be legitimately administered with cilostazol. Measured by professionally trained clinicians.~The higher score indicates more severe white matter lesion. Max-min: 0-3"|Baseline|||participants|||Number
43555|NCT01409564|Secondary|Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)|"Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms.~Score Scale: 0-18 (min-MAX)"|Baseline, 12-month, 24-month|||units on a scale||Standard Deviation|Mean
43556|NCT01409564|Secondary|Activities of Daily Living (ADCS-ADL)|"The caregiver answered to the questions given to measure the cognitive function level of the patients in daily living. Lower scores indicate greater severity.~23 questions Score Scale: 0-78 (min-MAX)"|Baseline, 12-month, 24-month|||units on a scale||Standard Deviation|Mean
43557|NCT01409564|Secondary|Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)|Basic cognitive functions are checked. (0-30) The score is better when higher.|Baseline, 12-month, 24-month|||units on a scale||Standard Deviation|Mean
43558|NCT01409564|Secondary|Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog)|"The ADAS-Cog score is measured by the number of questions answered incorrectly, therefore the higher is the worse.~Score Scale: 0-75 (min-MAX)~Each subcategory scores are summed.~Word-recall test (0-10)~Commands (0-5)~Constructional praxis (0-5)~Naming Objects/ Fingers (0-5)~Ideational Praxis (0-5)~Orientation (0-8)~Word Recognition (0-12)~Remembering Test Instructions (0-5)~Spoken Language Ability (0-5)~Word Finding Difficulty (0-5)~Comprehension (0-5)"|Baseline, 12-week, 24-week|||units on a scale||Standard Deviation|Mean
43559|NCT01409564|Primary|Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method|Regional cerebral glucose uptake level was measured as the ratio value of FDG uptake of the each unit level to the global mean uptake value.|Baseline, 24-week|Number of patients with increased whole brain glucose uptake level. In the real analysis, however, a voxel-based image analysis results were used; therefore, data which can be entered here is not much meaningful.||Bq/Bq (no unit)||Standard Deviation|Mean
43560|NCT01409434|Secondary|High Density Lipoprotein (mg/dL)||High Density Lipoprotein was obtained at time 0 min.|||mg/dL||Standard Deviation|Mean
43561|NCT01409434|Secondary|Low Density Lipoprotein (mg/dL)||Low Density Lipoprotein was obtained at time 0 min.|||mg/dL||Standard Deviation|Mean
43562|NCT01409434|Secondary|Triglycerides (mg/dL)||Triglycerides was obtained at time 0 min.|||mg/dl||Standard Deviation|Mean
43563|NCT01409434|Secondary|Oral Glucose Tolerance Test (mg/dl h)|Area under the curve for the OGTT was calculated for each patient using the 3 time points (0 hour, 1 hour and 2 hour). Average value for participants is provided.|one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)|Patients that underwent an OGTT||mg/dL*h||Standard Deviation|Mean
43564|NCT01409434|Primary|Fasting Glucose (mg/dL)||Fasting glucose was obtained at time 0 min.|A total of 44 patients were included in the study, however 4 patients were treated with anti-diabetic medications and so were excluded from the analysis. Therefore there are a total of 40 patients that were included in the analysis.||mg/dL||Standard Deviation|Mean
43565|NCT01409382|Other Pre-specified|Pregnancy and Neonatal Outcomes|Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies|Three years|||participants (babies)|||Number
43619|NCT01407276|Primary|Apparent Total Body Clearance (CL/F) of Omarigliptin|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||mL/min||95% Confidence Interval|Geometric Mean
43566|NCT01409382|Secondary|Refractory Hypoglycemia|"Any glucose level ≤ 40/dL at 1, 2 or 4 h:~Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.~A new heel stick blood sample will be drawn to assess glucose levels.~Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia."|One hour after feeding or after intravenous dextrose|All hypoglycemic neonates were screened for refractory hypoglycemia. Only neonates born to mothers who were physically inactive and reported excessive carbohydrate consumption displayed refractory hypoglycemia.||neonates with refractory hypoglycemia|||Number
43567|NCT01409382|Primary|Neonatal Hypoglycemia|Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.|1, 2 and 4 h after birth.|||neonates|Participants||Number
43568|NCT01409291|Secondary|Fast Food Meals Per Week|Mean number of fast food meals per week|1 year|||meals per week||Standard Deviation|Mean
43569|NCT01409291|Primary|Minutes of Exercise Per Week|Mean minutes of exercise per week|1 year|||minutes||Standard Deviation|Mean
43570|NCT01409239|Primary|Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group|difference in mean low frequency/high frequency heart rate variability (LF/HF HRV)at 6 hour. 2 patients were excluded who did not have usable LF/HF HRV data at 6 hours. These patients remained in the study as they did have other measures.|6 hour|||none (ratio)||Inter-Quartile Range|Median
43571|NCT01409213|Primary|Change From Baseline for Mean Fasting Blood Glucose (FBG)|Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.||mg/dL||Standard Deviation|Mean
43572|NCT01409213|Primary|Change From Baseline for Mean Hemoglobin A1c (HbA1C)|Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.||Percent of glycosylated hemoglobin||Standard Deviation|Mean
43573|NCT01409096|Secondary|Hamilton Rating Scale for Anxiety (HRSA)|"The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where less than 17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|12 weeks|||units on a scale||Standard Error|Least Squares Mean
43574|NCT01409096|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).~Score:~Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks|||units on a scale||Standard Error|Least Squares Mean
43575|NCT01409096|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.~Score:~Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks|||units on a scale||Standard Error|Least Squares Mean
43576|NCT01409096|Primary|The 17-item Hamilton Rating Scale for Depression (HRSD17)|"The HRSD is an observer-rated measure of depressive symptomatology.~Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less."|12 weeks|||units on a scale||Standard Error|Least Squares Mean
43577|NCT01408992|Primary|Standard Hearing Test|Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB).|Baseline|||participants|||Number
43578|NCT01408992|Post-Hoc|Sensitivity of FMHT to Detect the Hearing Loss.|"FMHT has 15 questions and there are 4 possible answer for each question. The best possible answer is never and is scored 0, occasionally is scored 1, half the time is scored 2 and almost always the worst answer is scored 3. The total possible range for the FMHT scores 0-45. We then compared the total score with the better hearing ears as in Outcome measure 1. The total number of participants with a score from 0 to 45, and that all participants in the study had a score within this range. It would appear, from information provided in the previous version of this record, that the total score might range from 0 to 45."|baseline|The frequencies of subjects who had FMHT score from 0 to 45 were counted.||participants|||Number
43579|NCT01408992|Secondary|Prevalence of Ear Diseases|the frequency of diseased ears per the total examined ears|Immediate|||ears|Participants||Number
43580|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 tmax data.||hours||Full Range|Median
43581|NCT01408888|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 Cmax data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
43582|NCT01408888|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265|Area under the LY2189265 pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (168 hours) is summarized.|Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 AUC data.||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
43583|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin||Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin tmax data||hours||Full Range|Median
43584|NCT01408888|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin||Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin Cmax data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
43585|NCT01408888|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin|Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (24 hours) is summarized.|Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin AUC data.||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
43586|NCT01408862|Primary|Changes in Basal or Aggregant-induced Platelet Activation (With and Without Glucose Added to the Media, 200 mg/dl, 400 mg/dL) by GLP-1-(7-36)NH2 and Its Metabolite (GLP-1-(9-36)NH2)and a GIP Agonist at Different Concentrations.|"1 Direct effect of GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist on platelet aggregation, with and without preincubation at different glucose concentrations.~2. GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist modulation (with and without 300 mg/dL glucose added to the media) of platelet activation and aggregation induced by classical platelet agonists such as ADP, collagen and bovine von Willebrand factor.~Data points from various conditions were combined (averaged),"|Platelets drawn from a volunteer will be evaluated 1 time (in 1-2 days)|We assume that with 10 samples per condition divided in 5 categories (1 control plus 4 concentrations of GLP1 and GIP agonists) for a standardized difference of 0.5 between groups and a p=0.05, the statistical power would be higher than 90%. We used a similar design to test the effect of GLP1 and GIP agonists on platelet aggregants.||% of Inhibition||Standard Deviation|Mean
43587|NCT01408862|Primary|Expression of Glucagon Like Peptide -1 (GLP-1) and Gastric Inhibitory Peptide (GIP) Receptors in Normal Human Platelets|1.1 Measurement of GLP-1 and GIP receptors at the platelet RNA level by Real Time-PCR 1.2 GLP-1 and GIP receptors detection at the protein level: 1.2.1 Expression on platelet membrane by flow cytometry. 1.2.2 Detection in total platelet proteins by western-blot. Data of flow cytometry are provided below|Platelets drawn from a volunteer were evaluated 1 time (in 1-2 days)|||percentage of positive cells||Standard Deviation|Mean
43588|NCT01408719|Secondary|Changes in Body Weight and Waist Circumference(WC)|Body weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.|Every day for body weight; beginning and end of each phase for WC||||||
43589|NCT01408719|Primary|Changes in LDL Cholesterol|Serum LDL cholesterol will be estimated using the Friedewald equation.|Beginning and end of each phase||||||
43590|NCT01408719|Secondary|Potential Gene-nutrient Interactions: CYP7A1 and APOE|The Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.|Once for each participant||||||
43591|NCT01408719|Secondary|Cholesterol Absorption/Synthesis|The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.|End of each phase||||||
43592|NCT01408719|Primary|Changs in Total Cholesterol|Fasted total cholesterol concentration will be measured using the automated enzymatic methods.|Beginning and end of each phase|||mmol/L||Standard Error|Least Squares Mean
43593|NCT01408329|Primary|Plasma Glucose Concentration||Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10–12 h fast the morning after a CVAC session (except for baseline).|Those that completed the study||mg/dl||Standard Deviation|Mean
43594|NCT01408303|Primary|Serum Non-HDL Cholesterol|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.|6 weeks|"The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented."||Percent change from baseline||95% Confidence Interval|Least Squares Mean
43595|NCT01408277|Primary|Mean Percent Change in Wound Area|Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.|6 and 12 weeks|Primary analysis was based on the Intent-to-treat dataset which consisted of all subjects randomized to treatment.||percentage of change in wound area||Standard Error|Mean
43596|NCT01407575|Primary|Weight|Participant weight|6 weeks|||lbs||Standard Deviation|Mean
43597|NCT01407575|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|6 weeks|||Beats per minute||Standard Deviation|Mean
43598|NCT01407575|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 – 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 – 50, with lower scores representing lower levels of negative affect."|6 weeks|reduced sample size verified. This was secondary to administrative error.||units on a scale||Standard Deviation|Mean
43599|NCT01407575|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|6 weeks|||units on a scale||Standard Deviation|Mean
43600|NCT01407575|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|6 weeks|||units on a scale||Standard Deviation|Mean
43601|NCT01407575|Primary|Blood Pressure|Measure of systolic and diastolic blood pressure. 140/90 or lower is considered normal and indicates a better outcome.|6 weeks|||mm Hg||Standard Deviation|Mean
43602|NCT01407575|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity Theoretical Range 0-60 lower values represent better outcome|6 weeks|||units on a scale||Standard Deviation|Mean
43603|NCT01407523|Secondary|Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|During the Evaluation Period (Day 1 to Day 4)|Full Analysis Set (FAS). The FAS consisted of all subjects in the Safety Set (SS) with evaluable seizure frequency data over the Evaluation Period. All 16 subjects in the SS are included in the FAS.||Seizures per day||Inter-Quartile Range|Median
43951|NCT01401153|Primary|Tonic Alertness (Deviation of Reaction Time)|Deviation of reaction time --> logarithmic standard deviation of the reaction times|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Unitless||Inter-Quartile Range|Median
43604|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
43605|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
43606|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
43607|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
43608|NCT01407523|Primary|Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)|A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)||participants|||Number
43609|NCT01407523|Primary|Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)||participants|||Number
43610|NCT01407354|Secondary|Number of Movement Recorded by Activity Monitor (SAM)|SAM movements not just steps were gathered one time pre, crossover and post and worn on ankle for 5 days; percent change for each intervention|7 months|||number of movements||Standard Deviation|Mean
43611|NCT01407354|Primary|Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak|Peak VO2 via Arm Ergometer and Lokomat with metabolic cart|7 months|||participants|||Number
43612|NCT01407276|Secondary|Number of Participants Withdrawn From Study||Up to Day 15|All participants that received a single 3 mg dose of omarigliptin.||Participants|||Number
43613|NCT01407276|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|From pre-dose to 14 days post-dose (Up to Day 15)|All participants that received a single 3 mg dose of omarigliptin.||Participants|||Number
43614|NCT01407276|Primary|Apparent Terminal Half-life (t1/2) of Omarigliptin|T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||hour||Standard Deviation|Mean
43615|NCT01407276|Primary|Time to Maximum Concentration (Tmax) of Omarigliptin|Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||hour||Full Range|Median
43616|NCT01407276|Primary|Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin|Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||mg||95% Confidence Interval|Least Squares Mean
43617|NCT01407276|Primary|Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin|fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||Percentage of total dose||95% Confidence Interval|Geometric Mean
43618|NCT01407276|Primary|Renal Clearance (CLr) of Omarigliptin|CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||mL/min||95% Confidence Interval|Geometric Mean
43620|NCT01407276|Primary|Apparent Volume of Distribution (Vd/F) of Omarigliptin|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||L||95% Confidence Interval|Geometric Mean
43621|NCT01407276|Primary|Concentration at 168 Hours Post-dose (C168h) of Omarigliptin|C168h is a measure of the plasma drug concentration 168 hours post-dose.|168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM||95% Confidence Interval|Geometric Mean
43622|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin|AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM*hr||95% Confidence Interval|Geometric Mean
43623|NCT01407276|Primary|Maximum Concentration (Cmax) of Omarigliptin|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM||95% Confidence Interval|Geometric Mean
43624|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.||nM*hr||95% Confidence Interval|Geometric Mean
43625|NCT01407068|Secondary|Clinical Success by Joint Type|Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.|30 days after injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||number of joints|Participants||Number
43626|NCT01407068|Primary|Change in Total Range of Motion|The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||degrees||Standard Deviation|Mean
43627|NCT01407068|Secondary|Investigator Assessment of Improvement With Treatment|"At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject’s treated finger(s) compared with screening as follows:~Very Much Improved~Much improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||participants|||Number
43628|NCT01407068|Secondary|Subject Satisfaction With Treatment|"At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows:~Very Satisfied~Quite Satisfied~Neither Satisfied nor Dissatisfied~Quite Dissatisfied~Very Dissatisfied"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||participants|||Number
43629|NCT01407068|Primary|Percent Change From Baseline in Total Fixed Flexion|Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.||percentage of contracture change||Standard Deviation|Mean
43630|NCT01406990|Primary|Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin|Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.|Time of enrollment|||participants|||Number
43631|NCT01406938|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies will decrease a participant’s ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60|Baseline, weeks 12, 24, 52 and 60|Full analysis set (FAS) - All patients to whom study treatment was assigned||Number of participants|||Number
43632|NCT01406938|Secondary|Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12|The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12|week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||percent of participants|||Number
43633|NCT01406938|Secondary|Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participants|||Number
43952|NCT01401153|Primary|Tonic Alertness (Mean Reaction Time)|Mean reaction time to response to a simple visual stimulus without a preceding warning signal|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Milliseconds||Inter-Quartile Range|Median
43634|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included||Percent of participants|||Number
43635|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included||Percent of participants|||Number
43636|NCT01406938|Secondary|Median Time to Relapse (Weeks) From Week 12.|Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement|Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned||Number of weeks||95% Confidence Interval|Median
43637|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participant|||Number
43638|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participants|||Number
43639|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
43640|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
43659|NCT01405937|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43641|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
43642|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
43643|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant’s disease state at the time of the assessments and does not attempt a comparison to any of the participant’s previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe|Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participants|||Number
43644|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe|Baseline, week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Percent of participant|||Number
43645|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
43646|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 2, 3 , 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned||Units on a scale||Standard Deviation|Mean
43647|NCT01406938|Primary|For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 40 , week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned.||Percent of participants|||Number
43648|NCT01406574|Secondary|Best Overall Response|Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.|From first dose of study medication up to 28 weeks|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.~No statistical analysis provided for Best Overall Responders."||participants|||Number
43660|NCT01405937|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43678|NCT01405794|Primary|Cytochrome P450 Assay on Midazolam in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
43649|NCT01406574|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.~DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice"|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|"DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4.~No statistical analysis provided for Subjects With DLTs."||participants|||Number
43650|NCT01406574|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame.|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.||participants|||Number
43651|NCT01405950|Secondary|Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day~0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine~PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population||nanogram/mililiter||Standard Error|Mean
43652|NCT01405950|Primary|Pharmacokinetic (PK) Parameter AUC0–8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day~0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine~PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population||hour*nanogram/mililiter||Standard Error|Mean
43653|NCT01405937|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants|||Number
43654|NCT01405937|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|Participants in the FAS population (all randomized participants who received at least one dose of study treatment) that had HCV RNA data available.||Log IU/ml||Standard Deviation|Mean
43655|NCT01405937|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants||95% Confidence Interval|Number
43656|NCT01405937|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
43657|NCT01405937|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.||Percentage of participants||95% Confidence Interval|Number
43658|NCT01405937|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43677|NCT01405794|Secondary|Total Change in Systolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days|||mmhg||95% Confidence Interval|Mean
43661|NCT01405924|Secondary|Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy|Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
43662|NCT01405924|Secondary|Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy|"Participants rated their degree of nausea in response to How much nausea have you had over the last 24 hours? using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score <25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated."|From 24 to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
43663|NCT01405924|Secondary|Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy|"The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. No Impact on daily life was defined as a FLIE Total Score >108. Participants completed the FLIE questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days."|From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2)|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Score on a Scale||Standard Deviation|Mean
43664|NCT01405924|Secondary|Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy|A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
43665|NCT01405924|Secondary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data. Participants were grouped into 2 cohorts based on type of chemotherapy received.||Percentage of Participants|||Number
43666|NCT01405924|Primary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.||Percentage of Participants|||Number
43667|NCT01405898|Secondary|Difference in Change in Arterial Stiffness From Baseline|carotid-femoral pulse wave velocity [m/s] measured by Vicorder|4 weeks|||m/s||Standard Deviation|Mean
43668|NCT01405898|Primary|Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
43669|NCT01405898|Primary|Difference in Change in Ambulatory Systolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
43670|NCT01405898|Primary|Difference in Change in Clinic Diastolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
43671|NCT01405898|Secondary|Difference in Change in Endothelial Function From Baseline|as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function|4 weeks|||% dilatation||Standard Deviation|Mean
43672|NCT01405898|Secondary|Difference in Change in Plasma Nitrite Concentration From Baseline||4 weeks|||umol/L||Standard Deviation|Mean
43673|NCT01405898|Primary|Difference in Change in Clinic Systolic Blood Pressure From Baseline||4 weeks|||mmHg||Standard Deviation|Mean
43674|NCT01405820|Primary|Cumulative Number of Combined Unique Active Lesions|Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.|Up to Week 60|Modified intent-to-treat (mITT) population: all randomized participants who received at least 1 dose of study drug, had at least 1 efficacy assessment, and had no statistical protocol deviations.||lesions||Standard Deviation|Mean
43675|NCT01405794|Secondary|Total Change in Heart Rate in Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days|||beats per minute||95% Confidence Interval|Mean
43676|NCT01405794|Secondary|Total Change in Diastolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days|||mmhg||95% Confidence Interval|Mean
43679|NCT01405794|Secondary|Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
43680|NCT01405794|Primary|Cytochrome P450 Assay on Omeprazole in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
43681|NCT01405794|Primary|Cytochrome P450 Assay on Caffeine in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
43682|NCT01405794|Primary|Cytochrome P450 Assay on Losartan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
43683|NCT01405794|Primary|Cytochrome P450 Assay on Dextromethorphan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days|||ng/ml||Standard Deviation|Mean
43684|NCT01405794|Primary|Change In Eosinophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
43685|NCT01405794|Primary|Change In Basophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
43686|NCT01405794|Primary|Change In Monocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
43687|NCT01405794|Primary|Change In Lymphocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
43688|NCT01405794|Primary|Change In Granulocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
43689|NCT01405794|Primary|Change In Platelet Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||k/uL||Standard Deviation|Mean
43690|NCT01405794|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||gm/dL||Standard Deviation|Mean
43691|NCT01405794|Primary|Change In Mean Corpuscular Volume Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||fL||Standard Deviation|Mean
43692|NCT01405794|Primary|Change In Hematocrit Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||percent||Standard Deviation|Mean
43693|NCT01405794|Primary|Change In Hemoglobin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||gm/dL||Standard Deviation|Mean
43694|NCT01405794|Primary|Change In Red Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||M/uL||Standard Deviation|Mean
43695|NCT01405794|Primary|Change In White Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||k/uL||Standard Deviation|Mean
43696|NCT01405794|Primary|Change In Calcium Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dL||Standard Deviation|Mean
43697|NCT01405794|Primary|Change In Albumin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||g/dL||Standard Deviation|Mean
43698|NCT01405794|Primary|Change In Total Bilirubin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dL||Standard Deviation|Mean
43699|NCT01405794|Primary|Change in Total Protein Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||g/dL||Standard Deviation|Mean
43700|NCT01405794|Primary|Change In Alanine Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||U/L||Standard Deviation|Mean
43701|NCT01405794|Primary|Change In Aspartate Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||U/L||Standard Deviation|Mean
43702|NCT01405794|Primary|Change In Alkaline Phosphatase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||U/L||Standard Deviation|Mean
43703|NCT01405794|Primary|Change In Glucose Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dl||Standard Deviation|Mean
43704|NCT01405794|Primary|Change In Creatinine Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mg/dL||Standard Deviation|Mean
43705|NCT01405794|Primary|Change In Urea Nitrogen Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mg/dL||Standard Deviation|Mean
43706|NCT01405794|Primary|Change in Carbon Dioxide Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mmol/L||Standard Deviation|Mean
43707|NCT01405794|Primary|Change in Chloride Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mmol/L||Standard Deviation|Mean
43708|NCT01405794|Primary|Change Potassium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days|||mmol/L||Standard Deviation|Mean
43709|NCT01405794|Primary|Change Sodium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days|||mmol/L||Standard Deviation|Mean
43722|NCT01405560|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43710|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure|||units on a scale||Full Range|Median
43711|NCT01405768|Primary|Injection Pain Score (Median)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of the procedure|||units on a scale||Full Range|Median
43712|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure|||units on a scale||Standard Deviation|Mean
43713|NCT01405768|Primary|Injection Pain Score (Mean)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure|||units on a scale||Standard Deviation|Mean
43714|NCT01405742|Secondary|F.VIII Activity|F.VIII Activity (IU/mL) performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.|||IU/mL||Full Range|Median
43715|NCT01405742|Secondary|Inter-dose Hypocoagulability by Thrombin Generation|Thrombin generation was performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.|||nMs||Full Range|Median
43716|NCT01405742|Primary|Number of Bleeds|The primary outcome was bleed frequency. The data were total number of events for each Arm, and not per-participant.|Weeks 26 (first intervention) and 52 (second intervention)|3 completing study were analyzed||bleeds per 26 weeks|||Number
43717|NCT01405560|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants|||Number
43718|NCT01405560|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment.||Log IU/ml||Standard Deviation|Mean
43719|NCT01405560|Secondary|Percentage of Participants Achieving Undetectable HCV Ribonucleic Acid (RNA) at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43720|NCT01405560|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43721|NCT01405560|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43735|NCT01405469|Secondary|Reflux Symptoms|Number of Participants with Reflux Symptoms|during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment|||participants|||Number
43723|NCT01405560|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment||percentage of participants||95% Confidence Interval|Number
43724|NCT01405560|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)24|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
43725|NCT01405508|Secondary|Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period.|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|4.5-day Evaluation Period|Safety Population consisting of all subjects who took at least 1 dose of study drug.||Participants|||Number
43726|NCT01405508|Secondary|Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.||Participants|||Number
43727|NCT01405508|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.||Participants|||Number
43728|NCT01405469|Secondary|Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||percentage of treated patients|||Number
43729|NCT01405469|Secondary|Myotomy Length|myotomy length in cm|POEM procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||cm||Standard Deviation|Mean
43730|NCT01405469|Secondary|Duration Hospitalization|duration hospitalization (days)|hospitalization for POEM procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||days||Standard Deviation|Mean
43731|NCT01405469|Secondary|Duration Time Procedure|duration time of POEM procedures in minutes|procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||minutes||Standard Deviation|Mean
43732|NCT01405469|Secondary|Medication 3 Months After POEM|proton pump inhibitor (PPI) use at 3 months after POEM procedure|3 months|||participants|||Number
43733|NCT01405469|Secondary|Procedure-related Adverse Events|procedure-related adverse events per protocol|procedure to 3 months post procedure|||participants|||Number
43734|NCT01405469|Primary|Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||eckhardt score||Standard Deviation|Mean
43736|NCT01405469|Secondary|Pressure of the Lower Esophageal Sphincter 3 Months After POEM Procedure|esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure|manometry at 3 month after therapy|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.||mmHg||Standard Deviation|Mean
43737|NCT01405027|Secondary|Number of Participants With Adverse Events|Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs|Throughout entire study, at end of treatment and follow up week 24|||participants|||Number
43738|NCT01405027|Secondary|Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)|"Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs.~Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life."|Baseline, end of treatment, follow-up week 24|The Quality of Life scores are derived from the responses from subjects who completed questionnaires at protocol-scheduled timepoints.||score||Standard Deviation|Mean
43739|NCT01405027|Secondary|Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.|Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.|Follow-up week 24|Follow-up SVR includes data collected 10 weeks or greater from last treatment.||percentage of participants|||Number
43740|NCT01405027|Secondary|Drug Exposure|Total number of patients receiving treatment over specified time intervals.|End of treatment up to treatment week 48|||participants|||Number
43741|NCT01405027|Primary|Treatment Duration Compliance Rate|The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).|End of treatment up to treatment week 48|Population analyzed represents patients who had a PCR at treatment weeks where expected duration of treatment could have been determined. Subjects who discontinued the study due to Treatment Futility were considered to have 100% treatment duration compliance.||Percentage of compliance||95% Confidence Interval|Mean
43742|NCT01404988|Secondary|Self-reported Medication Adherence|Assessed using Morisky medication-taking scale. Higher score corresponds to worse adherence.|6 months from baseline|||participants|||Number
43743|NCT01404988|Secondary|Adherence to Beta Blockers|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline|||proportion of refill compliance||Inter-Quartile Range|Median
43744|NCT01404988|Secondary|Adherence to ACE Inhibitors and ARB|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months after baseline|||proportion of refill compliance||Inter-Quartile Range|Median
43745|NCT01404988|Primary|Medication Adherence (Refill Compliance for All HF Medications)|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline visit|||proportion of refill compliance||Inter-Quartile Range|Median
43781|NCT01404234|Secondary|Change From Baseline in FEV1 % Predicted in Subjects Aged ≥ 6 Years|"The change in FEV1 % predicted was assessed at the end of each 28-day AZLI treatment course.~FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.||percentage of FEV1 % predicted||Standard Deviation|Mean
43746|NCT01404936|Primary|Participants' Response|Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: > 25 % increase in size of any measurable lesion or appearance of significant new lesions.|After 6 courses (3 months)|Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.||participants|||Number
43747|NCT01404923|Primary|Percentage of Improvement of the Total IBSQoL Scores|Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage|Baseline and 6 Months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at lesat one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.||% of improvement of IBSQoL total scores||Standard Deviation|Mean
43748|NCT01404923|Primary|Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score|Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.|Baseline and 6 months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at least one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.||units on a scale||Standard Error|Mean
43749|NCT01404832|Secondary|Number of Patients Who Had Resolution of Heartburn With Lansoprazole|Resolution of heartburn defined as >50% improvement in symptoms|After 8 weeks of treatment|||participants|||Number
43750|NCT01404832|Primary|Number of Participants With Eosinophilic Esophagitis||8 weeks|||participants|||Number
43751|NCT01404650|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Worst toxicity grades per patient were tabulated for select adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.0|Days 1, 8 and 15 of each 21-day cycle plus 30 days after treatment discontinuation.|All participants who received at least one dose of study drug.||participants|||Number
43752|NCT01404650|Secondary|Overall Survival (OS)|Evidence of survival was obtained by clinic visit or telephone contact from the time of first dose until death from any cause.|Every 3 months until patient death or lost to follow-up, for up to 4 years.|All 25 patients who received treatment were included in the analysis of overall survival.||months||95% Confidence Interval|Median
43753|NCT01404650|Secondary|Response Rate (RR)|Defined as the proportion of complete and partial responses, assessed per RECIST v1.1. Complete response (CR) defined as a disappearance of all lesions; partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|At 6 and 12 weeks then every 9 weeks thereafter until progressive disease or intolerable toxicity, for up to 4 years.|Of 25 patients enrolled, 4 patients were not evaluable for response due to treatment discontinuation prior to first disease evaluation.||percentage of participants|||Number
43754|NCT01404650|Primary|Progression-free Survival (PFS)|Measured from time of randomization until objective tumor progression or death; assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions.|At 6 and 12 weeks then every 9 weeks thereafter until progression or intolerable toxicity, up to 4 years.|||months||95% Confidence Interval|Median
43755|NCT01404611|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study (up to 22 days)|||days||95% Confidence Interval|Median
43756|NCT01404572|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.|||||
43757|NCT01404572|Secondary|Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Study Day 1|All participants who tasted at least 1 dose of atazanavir||Participants|||Number
43758|NCT01404572|Secondary|Number of Participants With Abnormal Findings on Electrocardiograms||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.|||||
43759|NCT01404572|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.|||||
43760|NCT01404572|Primary|Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Standard Deviation|Mean
43761|NCT01404572|Secondary|Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Standard Deviation|Mean
43762|NCT01404572|Secondary|Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Full Range|Median
43763|NCT01404572|Primary|Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir||Units on a scale||Full Range|Median
43764|NCT01404559|Primary|Bioenergetics Between Feet Components 21 Days After Fitting Prostheses|Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.|21 days total (7days per prosthetic foot condition)|||ml O2/kg/min||Standard Deviation|Mean
43765|NCT01404559|Primary|Obstacle Course Completion Time|Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.|21 days total (7days per prosthetic foot condition)|||seconds||Standard Deviation|Mean
43766|NCT01404429|Secondary|Proportion Who Withdrew Due to Intolerance||3 months|||participants|||Number
43767|NCT01404429|Secondary|Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)||3 months||||||
43768|NCT01404429|Secondary|Proportion of Patients Who Withdrew Because of Any Cause||3 months|||participants|||Number
43769|NCT01404429|Primary|Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)||3 months|||participants|||Number
43770|NCT01404429|Primary|Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline|DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity|12 weeks|||units on a scale||Standard Deviation|Mean
43771|NCT01404260|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .|The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured|Efficacy analysis, including PFS will be based on intent to treat (ITT) population.. ITT population includes all the randomised patients who receive at least one dose of study treatment with at least one baseline data of volume of plaque and at least one data after treatment.||months||95% Confidence Interval|Median
43772|NCT01404234|Secondary|Adverse Event Rates Adjusted for Study Duration|Adverse events occurring in ≥ 5% of participants adjusted for study duration were summarized. The adjustment was made by using a standardized rate calculated as the sum of study duration across patients divided by 28 for the total number of patient months. Rate calculations presented are the number of adverse events (AEs) per patient month.|Baseline to Day 168|Full Analysis Set||AEs (per patient month)|||Number
43773|NCT01404234|Secondary|Percentage of Participants With Study-drug Induced Bronchospasm|Study-drug induced bronchospasm (airway reactivity) was assessed at the baseline visit as the percent change in FEV1 from the pretreatment measurement to 30 minutes following treatment for subjects ≥ 6 years or as from the Investigator's assessment for subjects < 6 years.|Pretreatment at Baseline to 30 minutes following treatment|Full Analysis Set||percentage of participants|||Number
43774|NCT01404234|Secondary|Time to Pulmonary Exacerbation|The median days to first pulmonary exacerbation was summarized using Kaplan-Meier (KM) summary statistics.|Baseline to Day 168|Full Analysis Set||days||95% Confidence Interval|Median
43775|NCT01404234|Secondary|Percentage of Participants With Pulmonary Exacerbations|Pulmonary exacerbations were defined as respiratory hospitalizations or discrete courses of non-study IV/inhaled antipseudomonal antibiotics. Use of oral antibiotics alone for respiratory signs or symptoms was considered to be representative of milder clinical events and, therefore, was not included in the definition of pulmonary exacerbations.|Baseline to Day 168|Full Analysis Set||percentage of participants|||Number
43776|NCT01404234|Secondary|Number of Days Participants Were Hospitalized Due to a Respiratory Event|The average number of days hospitalized due to a respiratory event, among the 11 participants who were hospitalized for respiratory event, was reported.|Baseline to Day 168|Full Analysis Set||days||Standard Deviation|Mean
43777|NCT01404234|Secondary|Percentage of Participants Hospitalized at Least Once Due to a Respiratory Event||Baseline to Day 168|Full Analysis Set||percentage of participants|||Number
43778|NCT01404234|Secondary|Percentage of Participants Who Used Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (IV, inhaled, oral, IV/inhaled, IV/inhaled/oral) was summarized (number and percent) for all subjects.|Baseline to Day 168|Full Analysis Set||percentage of participants|||Number
43779|NCT01404234|Secondary|Change in Pseudomonas Aeruginosa (PA) Sputum Density|The change in PA sputum density (log10 colony-forming units per gram [cfu/g]) was assessed at the end of each 28-day AZLI treatment course.|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.||log10 CFU/g||Standard Deviation|Mean
43780|NCT01404234|Secondary|Change From Baseline in CFQ-R Respiratory Symptoms Scale (RSS) Score in Subjects Aged ≥ 6 Years|"The change in CFQ-R RSS score was assessed at the end of each 28-day AZLI treatment course.~The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.||units on a scale||Standard Deviation|Mean
43782|NCT01404234|Primary|Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons|Participants who discontinued study drug due to safety or tolerability reasons were defined as those with “Adverse Event (AE)/Safety or Tolerability” on the Study Drug Completion electronic case report form as the reason for early discontinuation. The 95% confidence interval (CI) was calculated using the exact binomial method.|Baseline to Day 168|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study medication) who completed the study or discontinued study drug due to safety or tolerability reasons were analyzed. Two participants voluntarily withdrew from the study prior to completion (not due to AEs/safety or tolerability reasons).||percentage of participants||95% Confidence Interval|Number
43783|NCT01404078|Secondary|Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics||8 weeks||||||
43784|NCT01404078|Primary|Tolerability of a Double Dose of Half Strength Polycap||8 weeks||||||
43785|NCT01404078|Primary|BLOOD PRESSURE LIPIDS|Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose.|8 weeks|||mmHG||95% Confidence Interval|Mean
43786|NCT01403987|Secondary|Readmission and Mortality Rates|Percentage of patients in each arm that were either readmitted within 30 days or died within 90 days (ie a combined endpoint of either/or readmission or death)|18 months|||percentage of patients|||Number
43787|NCT01403987|Secondary|Improvement in Guideline Adherence|Improvement in adherence to AASLD guidelines is summarized as yes or no improvement based on investigator chart review performed prior to and after the intervention. This is not a measure of resident reporting adherence but rather investigator interpretation of patient care and whether care was in line with published guidelines.|18 months|||percentage of participants|||Number
43788|NCT01403987|Primary|Score Out of Total Possible 25 on a Likert Scale.|"Primary outcome is quantified by summation of Likert scale responses to five questions assessing for comfort level in caring for and managing inpatients with ascites. The scale ranges from strongly disagree, which is assigned a value of 1, to strongly agree, assigned a value of 5. The summation scores will therefore range from 5 to 25 points out of a total of 25 possible points. The post-intervention scores will be compared between groups using a multiple regression model with terms for treatment, baseline summary scores, and other baseline demographic variables as needed."|6 months|Those who provided both baseline and follow up surveys||units on a Likert scale (maximum is 25)||Standard Deviation|Mean
43789|NCT01403805|Other Pre-specified|Died Before Oral Care Starting|Number of resident died before the start of oral care|This participant was died before treatment, Day 1|"This participant was determined as Not Completed due to Died before oral care starting. We excluded this participant from analysis for outcome measure."||participants|||Number
43790|NCT01403805|Other Pre-specified|Reject Vaccine|Number of resident to reject vaccine|These participants rejected vaccine before treatment, Day 1|"These participants were determined as Not Completed due to Reject vaccine. We excluded these participants from analysis for outcome measure."||participants|||Number
43791|NCT01403805|Other Pre-specified|Reject Oral Care|Number of resident to reject oral care|This participant rejected oral care before treatment, Day 1|"This participant was determined as Not Completed due to Reject oral care. We excluded this participant from analysis for outcome measure."||participants|||Number
43792|NCT01403805|Other Pre-specified|Leaving Nursing Home|Numer of resident for leaving nursing home|These participants were followed for the duration of nursing home stay, an average of 22 weeks.|"These participants were determined as Not Completed due to Leaving nursing home. We excluded these participants from analysis for outcome measure."||participants|||Number
43793|NCT01403805|Secondary|Death From Pneumonia|Number of participants for the death from pneumonia|1 year|||participants|||Number
43794|NCT01403805|Primary|Number of Participants With Pneumonia|Number of Participants with Pneumonia sufferers|1 year|||participants|||Number
43795|NCT01403376|Secondary|Immunoglobulin Levels||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||g/L||Standard Deviation|Mean
43796|NCT01403376|Secondary|Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||ratio post/pre vaccination||90% Confidence Interval|Geometric Mean
43797|NCT01403376|Secondary|Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 4-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||percentage of participants||90% Confidence Interval|Number
43798|NCT01403376|Secondary|Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 2-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined||percentage of participants||90% Confidence Interval|Number
43799|NCT01403376|Primary|Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination|"For each viral strain (H1N1, H3N2, and B), the antibody titer, level of antibodies in blood sample when exposed to antigen, was calculated as the mean of two replicates. If the titer was below or above the limit of detection, the threshold value was used.~The percentage of participants achieving a titer of 40 or more, as well as the 90% confidence interval (CI) using normal approximation were calculated for each strain and treatment group."|28 days post vaccination|Per-protocol population: Enrolled and vaccinated participants with antibody assessments at Day 28, but excluding those with important events/deviations potentially impacting analysis (multiple sclerosis relapse, poor compliance to treatment, interfering concomitant drug). Participants were considered according to the treatment actually received.||percentage of participants||90% Confidence Interval|Number
43800|NCT01403194|Secondary|Change in Level of Lipids||baseline, 3 months|Only one participant returned for the 3 month visit.|||||
43801|NCT01403194|Secondary|Change in Level of Fasting Insulin||baseline, 3 months|Only one participant returned for the 3 month visit.|||||
43802|NCT01403194|Primary|Change in Level of Fasting Glucose||baseline, 3 months|Only one participant returned for the 3 month visit.|||||
43804|NCT01403051|Secondary|The Changes From Baseline in iPTH to Weeks 24 and 48|iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."||pg/mL||Inter-Quartile Range|Median
43805|NCT01403051|Secondary|The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48|Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline].|Weeks 0, 4, 12, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=78 and 86 for changes at week 4, n=77 and 85 for changes at week 4, n=76 and 84 for changes at week 24, n=69 and 80 for changes at week 48."||cells/mm^3||Inter-Quartile Range|Median
43806|NCT01403051|Secondary|The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48|"Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Fractional Excretion of Phosphate (in %) is defined as:~[Urine Phosphate x Serum Creatinine] / [Urine Creatinine x Serum Phosphate] x 100%"|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=58 and 70 for changes at week 24, n=59 and 69 for changes at week 48."||percent||Inter-Quartile Range|Median
43807|NCT01403051|Secondary|The Changes From Baseline in Fasting LDL to Weeks 24 and 48|Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=70 and 72 for changes at week 24, n=65 and 67 for changes at week 48."||mg/dL||Inter-Quartile Range|Median
43808|NCT01403051|Secondary|The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48|Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=74 and 80 for changes at week 24, n=68 and 73 for changes at week 48."||mg/dL||Inter-Quartile Range|Median
43809|NCT01403051|Secondary|The Changes From Baseline in HOMA-IR to Weeks 24 and 48|Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=69 and 73 for changes at week 24, n=64 and 69 for changes at week 48."||HOMA-IR||Inter-Quartile Range|Median
43810|NCT01403051|Secondary|The Changes From Baseline in CTX to Weeks 24 and 48|CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."||ng/mL||Inter-Quartile Range|Median
43811|NCT01403051|Secondary|The Changes From Baseline in P1NP to Weeks 24 and 48|P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."||ng/mL||Inter-Quartile Range|Median
43812|NCT01403051|Secondary|The Changes From Baseline in sCD14 to Weeks 24 and 48|Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=68 and 68 for changes at week 24, n=62 and 63 for changes at week 48."||log10 ng/mL||Inter-Quartile Range|Median
43813|NCT01403051|Secondary|The Changes From Baseline in IL-6 to Weeks 24 and 48|Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=66 and 68 for changes at week 24, n=58 and 62 for changes at week 48."||log10 pg/mL||Inter-Quartile Range|Median
43814|NCT01403051|Secondary|The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48|"Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Total 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL"|Weeks 0, 24, and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=71 and 74 for changes at week 24, n=65 and 68 for changes at week 48."||ng/mL||Inter-Quartile Range|Median
43815|NCT01403051|Secondary|Number of Participants With Primary Adverse Events|Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table|From first study treatment to week 48|All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.||participants|||Number
43816|NCT01403051|Secondary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine|The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan|Weeks 0 and 48|This analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.||percentage change||Inter-Quartile Range|Median
43817|NCT01403051|Primary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip|The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)|Weeks 0 and 48|The primary analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.||percentage change||Inter-Quartile Range|Median
43818|NCT01402947|Primary|Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ng/ml||Standard Deviation|Mean
43819|NCT01402947|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.||ng*h/ml||Standard Deviation|Mean
43820|NCT01402869|Secondary|Delta Methemoglobin Blood Level|Change in percentage of methemoglobin in blood from baseline level to peak level|From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours|Per protocol||percentage of methemoglobin in blood||Standard Deviation|Mean
43821|NCT01402869|Secondary|Time to Peak Methemoglobin Blood Levels|The length of time between the administration of local anesthetic (Prilocaine and Lidocaine Groups) or start of restorative dental procedures (No local anesthetic Group) and the time at which the maximum methemoglobin blood level is observed.|Measured at 10 second intervals during dental treatment for an average of 2 hours|per protocol||minutes||Standard Deviation|Mean
43822|NCT01402869|Primary|Peak Methemoglobin Blood Levels|The maximum percentage of methemoglobin in blood|Measured at 10 second intervals during dental treatment for an average of 2 hours|Per protocol||percentage of methemoglobin in blood||Standard Deviation|Mean
43823|NCT01402817|Secondary|Volumetric Disease Evaluation|To determine the response rate with Sutent® in patients with plexiform neurofibromas using volumetric analysis of MRI scans|6 months|||percentage of subjects|||Number
43824|NCT01402817|Primary|Disease Response|To estimate the disease control rate (SD, PR, CR) with Sutent® in patients with neurofibromas (NF1). Tumor response criteria are determined by changes in size using all 3 dimensional measurements: width (W), transvers (T) , and length (L) measurements. Partial Response: ≥20% decrease in the sum of the products of the three perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements.Stable Disease (SD): Neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for PR (taking as reference the initial baseline measurements), nor sufficient increase in a single target lesions to qualify for PD, (taking as reference the smallest disease measurement since the treatment started).Progressive Disease (PD): 40% or more increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed.|6 months|||percentage of subjects||95% Confidence Interval|Number
43825|NCT01402700|Primary|Major Adverse Event Rate at 9 Months|The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.|9 months|||percentage of participants|||Number
43826|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue|Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one’s ability to carry out daily activities, including the ability to work effectively and to function at one’s usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.|Baseline, 1 month, 2 months and 3 months|||units on a scale||Standard Deviation|Mean
43827|NCT01402570|Primary|Steps Per Day|Count of steps per day using activity monitor worn on upper arm.|Baseline, 1 month, 2 months and 3 months|||steps per day||Standard Deviation|Mean
43828|NCT01402570|Primary|Sleep Efficiency|The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.|Baseline, 1 month, 2 months and 3 months|||units on a scale||Standard Deviation|Mean
43829|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning|Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.|Baseline, 1 month, 2 months and 3 months|||units on a scale||Standard Deviation|Mean
43830|NCT01402427|Secondary|Subjective Pain|Analysis of the rates of signiﬁcant pain deﬁned as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.|Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
43831|NCT01402427|Secondary|Contrast Volume||The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.|||milliliter||Inter-Quartile Range|Median
43832|NCT01402427|Secondary|Fluoroscopic Time||Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.|||minutes||Inter-Quartile Range|Median
43833|NCT01402427|Secondary|Procedural Time||Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.|||minutes||Inter-Quartile Range|Median
43834|NCT01402427|Secondary|Rate of Vasodilator Use||Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
43835|NCT01402427|Secondary|Rate of Code Breaks|Code break: a composite of access site conversion and unplanned use of vasodilators.|Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
43836|NCT01402427|Primary|Rate of Access Site Conversions||Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.|||participants|||Number
43837|NCT01402141|Primary|Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo)|"Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size was measured in study visit 1(0 week) and visit 3(12 week).~Percentage change in histamine-induced wheal size calculations were calculated by the formula ((12weeks - 0weeks) * 100/0weeks).~Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size compared with placebo."|12weeks|per protocol analysis||participants|||Number
43838|NCT01402141|Secondary|Changes in Eosinophil Cationic Protein(ECP)|Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||μg/L||Standard Deviation|Mean
43839|NCT01402141|Secondary|Changes in Eosinophil|Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||Percentage of WBCs(white blood cells)||Standard Deviation|Mean
43840|NCT01402141|Secondary|Changes in Interleukin-4|Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||pg/ml||Standard Deviation|Mean
43841|NCT01402141|Secondary|Changes in Interferon-gamma|Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||IU/ml||Standard Deviation|Mean
43842|NCT01402141|Secondary|Changes in Serum Histamine|Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||μg/g creatinine||Standard Deviation|Mean
43843|NCT01402141|Secondary|Changes in Immunoglobulin E|Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||IU/mL||Standard Deviation|Mean
43844|NCT01402141|Primary|Changes in Histamine-induced Wheal Size|Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||mm^2||Standard Deviation|Mean
43845|NCT01402128|Secondary|Changes in Subcutaneous Adipose Tissue|Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||cm^3||Standard Deviation|Mean
43846|NCT01402128|Primary|Changes in Percent Body Fat(%)|Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||percentage of body fat||Standard Deviation|Mean
43847|NCT01402128|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/L||Standard Deviation|Mean
43848|NCT01402128|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/l||Standard Deviation|Mean
43849|NCT01402128|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||µEq/L||Standard Deviation|Mean
43850|NCT01402128|Secondary|Changes in Triglyceride|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
43851|NCT01402128|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
43852|NCT01402128|Secondary|Changes in HDL-C(High Density Lipoprotein-cholesterol)|HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dl||Standard Deviation|Mean
43853|NCT01402128|Secondary|Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)|LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dl||Standard Deviation|Mean
43854|NCT01402128|Secondary|Changes in Visceral Adipose Tissue|Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||cm^3||Standard Deviation|Mean
43855|NCT01402128|Primary|Changes in Body Fat Mass(kg)|Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||kg||Standard Deviation|Mean
43856|NCT01402115|Secondary|Changes in PTH(Parathyroid Hormone)|PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||pg/mL||Standard Deviation|Mean
43857|NCT01402115|Secondary|Changes in bALP(Bone-specific Alkaline Phosphatase)|bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||U/L||Standard Deviation|Mean
43858|NCT01402115|Secondary|Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)|CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||µg/L||Standard Deviation|Mean
43859|NCT01402115|Primary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||ng/mL||Standard Deviation|Mean
43860|NCT01402115|Primary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
43861|NCT01402102|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||µEq/L||Standard Deviation|Mean
43862|NCT01402102|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/L||Standard Deviation|Mean
43863|NCT01402102|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||g/L||Standard Deviation|Mean
43864|NCT01402102|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dL||Standard Deviation|Mean
43865|NCT01402102|Secondary|Changes in Triglycerides|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis||mg/dl||Standard Deviation|Mean
43866|NCT01402102|Secondary|Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)|HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis||mg/dl||Standard Deviation|Mean
43867|NCT01402102|Primary|Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)|LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis||mg/dl||Standard Deviation|Mean
43868|NCT01402063|Primary|Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation|"MRI response evaluated by RANO criteria~Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response.~Partial Response (PR): Decrease of > 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan.~Progression (P): A > 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT."|Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.|||participants|||Number
43869|NCT01401842|Secondary|Dynamic Lumbar Extension Muscular Endurance at 11 Weeks|Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for this outcome (n = 11 stabilization arm; n = 18 strengthening arm).||repetitions||Standard Error|Mean
43870|NCT01401842|Secondary|Isometric Core Muscular Endurance at 11 Weeks|Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for primary outcome (n = 4 stabilization arm; n = 1 strengthening arm), and incomplete data for this outcome (n = 1 stabilization arm).||seconds||Standard Error|Mean
43871|NCT01401842|Primary|Isometric Lumbar Extension Muscular Strength at 11 Weeks|Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric lumbar extension muscular strength in Nm (mean ± SE) at follow-up||Nm||Standard Error|Mean
43872|NCT01400698|Post-Hoc|Duration of Participation in the Study||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluated for this measure.||years||Standard Deviation|Mean
43873|NCT01400698|Post-Hoc|Duration of Treatment||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were treated and hence, were evaluated for this measure.||years||Standard Deviation|Mean
43874|NCT01400698|Secondary|Parental Adjusted Height Standard Deviation Score (PAHSDS)|PAHSDS is the distance between the participant’s current and target heights, expressed in units of SD of the height distribution of the reference population. Target height is a measure of the height which the participant could hypothetically reach based only on his parents’ heights. Target height standard deviation score (THSDS) was calculated as target height minus mean adult height of the reference population divided by SD of the mean adult height of the reference population.|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.||standard deviation score||Standard Deviation|Mean
43875|NCT01400698|Primary|Height Standard Deviation Score (HSDS)|HSDS was calculated as height minus reference mean height divided by SD of the reference mean height, both given by the reference growth table (Sempe) for the corresponding chronological age at the height measurement. Greater HSDS indicate greater height. (Sempe M et al., 1979)|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.||standard deviation score||Standard Deviation|Mean
43876|NCT01400698|Primary|Final Height|Final height was defined as the height reached 1 year after height velocity (HV) was less than 2 centimeter/year (cm/year). Height velocity was the change in height since the previous year’s measurement. Height was measured with a wall-mounted stadiometer (or in supine position if the participant’s age was less than 3 years) and the measurement was repeated thrice by the same observer. The mean of the values obtained in the repeated measurements was taken for the analysis.|One year after final height was attained up to 10.6 years|Intention-to-treat (ITT) population included all participants enrolled in this study. Safety population was identical in this study.||cm||Standard Deviation|Mean
43877|NCT01401647|Secondary|Number of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|||Participants|||Count of Participants
43878|NCT01401647|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|The primary objective is to determine if survival to hospital discharge is improved with early therapeutic administration of IV amiodarone (PM101) compared to placebo.The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of Lidocaine vs placebo; PM101 vs lidocaine.||participants|||Number
43879|NCT01401517|Secondary|Assessment of Improvement of Quality of Life.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in measures of claudication symptoms at 10 weeks following the first administration of a dose. Quality of Life questionnaires (WIQ & RAND 36)will be completed prior to the first dose of the investigational product and again after 10 weeks of administration but before dose escalation.|10 weeks||||||
43880|NCT01401517|Secondary|Assessment of Changes in Walking Distance.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in functional measures of walking distance. The distance a subject can walk in 6 minutes will be measured prior to the first administration of the investigational product and 10 weeks after taking the investigational product but before the dose escalation.|10 weeks||||||
43881|NCT01401517|Secondary|Assessment of Changes in Brachial Artery Flow-Mediated Dilation (FMD)at 10 Weeks From Baseline|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in FMD by imaging before investigational product administration and 10 weeks after administration of investigational product but before dose escalation.|10 weeks||||||
43882|NCT01401517|Primary|Reporting of Adverse Events During 11 Week Treatment Period.|The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sodium nitrite compared with placebo over a 10 week treatment period. Subjects will be asked to report any adverse events during the trial period, and blood pressure, methemoglobin levels and other blood chemistries will be assessed during the trial period for changes from baseline.|11 weeks|||participants|||Number
43883|NCT01401478|Secondary|Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination|"The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded.~Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks."|6 months|||Percentage of participants||95% Confidence Interval|Number
43884|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
43885|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
43886|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
43887|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
43888|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.|6 months|The analysis for this outcome was based on the number of participants (55) who completed the study.||Percentage of participants||95% Confidence Interval|Number
43889|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
43890|NCT01401478|Primary|The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study|The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.|6 months|||Percentage of participants||95% Confidence Interval|Number
43891|NCT01401465|Secondary|The Percentage of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT||percentage of participants|||Number
43892|NCT01401465|Secondary|The Number of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT||participants|||Number
43893|NCT01401465|Secondary|The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT||percentage of participants|||Number
43894|NCT01401465|Secondary|The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT||participants|||Number
43895|NCT01401465|Secondary|Work/Disability Days: Reduced Activity Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|IIT||Incidence Rate (#events/person-days)|||Number
43896|NCT01401465|Secondary|Work/Disability Days: Missed Work|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population||Incidence Rate (#events/person-days)|||Number
43897|NCT01401465|Secondary|Work/Disability Days: Bed Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population||Incidence Rate (#events/person-days)|||Number
43898|NCT01401465|Secondary|Treatment Outcome Composite Score Assessed at the End of the Study|Reflects preference on items concerned with perceived drug effectiveness (longer relief; symptom relief; prefer if both were the same price; for feeling better about your appearance; for few problems with irritation to nose; faster relief; how it makes your nose feel). The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates an equal number of items preferred in the two groups. Larger values than 50 indicated greater than 50 percent of the subjects indicated preference for ciclesonide, while smaller values than 50 indicated greater than 50 percent preference for mometasone. Data is presented as the mean treatment outcome composite score. This analysis presents the comparison of ciclesonide versus mometasone in relation to preference for ciclesonide.|End of Study - Day 43|ITT Population||Scores on a scale||Standard Deviation|Mean
43899|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale|The mean of 1 question on how many days worked and 12 questions on level of satisfaction with work, ability to do work, problems completing work (physical and emotional); 1 questions on rating of leisure activities. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43900|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale|The mean of 11 questions on sleep disturbance, vitality and general health status. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43901|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale|The mean of 24 questions encompassing anxiety, depression, and loss of behavioral and emotional control (Psychological Distress), life satisfaction, positive well being and emotional ties (Psychological Well Being).Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43902|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale|The mean of 48 questions including allergic-rhinitis and allergic-rhinitis treatment specific and general symptoms measured for prevalence, frequency and distress severity. Scores range from 100 (lower satisfaction) to 600 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43903|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale|The mean of 7 questions concerning life interference due to nonallergic rhinitis specific symptoms (“other symptoms or health problems such as fatigue, pain and depression” with the same life activities: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) “feeling your best”. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43904|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale|The mean of 7 questions concerning interference with life activities due to the symptoms of allergic-rhinitis (nasal congestion, runny nose, itchy throat or sneezing) interfered with your ability to perform life activities. The life activities included: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) “feeling your best”. Scores range from 1 (lower satisfaction) to 6 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43905|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)|The mean of 5 questions: Feeling past month 1) overall or in general, 2) physically, 3) emotionally, 4) personal life and 5) about job or work. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43906|NCT01401465|Secondary|The Change From Baseline in Overall Quality of Life Composite Score|Mean of all items in the Mental and Emotional Health and General Health Perceptions scales. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT||scores on a scale||Standard Error|Least Squares Mean
43907|NCT01401465|Secondary|The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief|The patient’s perceived level of relief along with the degree of satisfaction associated with that amount of relief was evaluated within this scale. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43908|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management|This subscale evaluates the patient’s assessment of issues relating to dosing (number of times and the time required to dose), ability to remember to use the spray, the ease/difficulty of the spray and several questions further pertaining to the convenience of the treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43909|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Burden|This subscale evaluates the patient’s assessment of the level of degree of burden that treatment for allergic rhinitis imposes on a number of areas, including adherence to the treatment regimen, exercise, performing daily activities, social activities, and enjoying life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43953|NCT01401101|Primary|PTSD Symptoms|same as baseline and 6 months|12 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.||CAPS scores||95% Confidence Interval|Mean
43910|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle|This subscale focuses specifically on the patient’s assessment of the amount of bother and hassle of the treatment regimen, including coordinating activities, dosing, carrying supplies, rubbing nose or eyes, blowing nose repeatedly, or facial puffiness. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43911|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact|This subscale evaluates the patient’s assessment of the sensory attributes including medication running out of the nose, medication running down the throat, and impact on smell and taste. Issues regarding skipping the medication because of the way the nose feels and wanting to try other medications to find a better one are also included. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43912|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties|This subscale evaluates the patient’s degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43913|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation|This subscale evaluates the patient’s assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43914|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation|This subscale evaluates the patient’s assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43915|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Interference|This subscale evaluates the patient’s assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||units on a scale||Standard Error|Least Squares Mean
43916|NCT01401465|Secondary|Change From Baseline in the Regimen Acceptance Composite Score|A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||scores on a scale||Standard Error|Least Squares Mean
43917|NCT01401465|Secondary|Change From Baseline in the Treatment Functional Impact Composite Score|A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||scores on scale||Standard Error|Least Squares Mean
43918|NCT01401465|Secondary|Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.|The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.|Averages over each two week treatment period|Per Protocol (PP) Population||units on a scale||Standard Error|Least Squares Mean
43919|NCT01401465|Secondary|Treatment Process Composite Preference Score|The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less “Run out” of nose, Less “Run down” of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone.|End of Study - Day 43|ITT||scores on a scale||Standard Deviation|Mean
43954|NCT01401101|Primary|PTSD Symptoms|same as baseline|6 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.||CAPS scores||95% Confidence Interval|Mean
43920|NCT01401465|Primary|Change From Baseline in Regimen Attributes Composite Score|The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population||scores on a scale||Standard Error|Least Squares Mean
43921|NCT01401465|Primary|Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items|"For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less run out of nose, Longer relief, Less run down of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide."|End of Study - Day 43|Intent to Treat (ITT)- All randomized subjects who received at least one dose of study medication||scores on a scale||Standard Deviation|Mean
43922|NCT01401361|Secondary|Secondary Efficacy|"Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,~1c, III) during the 3 months post ablation are considered chronic failures."|3 months|134 subjects were treated with the investigational catheter and system with 10 subjects experiencing recurring AFL. Thus 124 subjects comprised the secondary efficacy cohort (freedom from AFL at 90 days).||participants|||Number
43923|NCT01401361|Primary|Primary Efficacy|Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes|134 subjects were treated with the investigational catheter and system with 1 subject failing to pass the bidirectional block inducibility test 30 minutes post ablation. Thus 133 subjects comprised the primary efficacy cohort.||participants|||Number
43924|NCT01401361|Primary|Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|150 subjects who met Inc/Excl criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 were treated. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.||participants|||Number
43925|NCT01401322|Primary|Time-to-Progression (TTP)||12 weeks|||Days||Full Range|Median
43926|NCT01401283|Secondary|Hospital Stay|length of stay in the postoperative care unit, length of hospital stay|Participants will be followed for the duration of hospital stay, an expected average of 10 days|||days||Inter-Quartile Range|Median
43927|NCT01401283|Primary|Postoperative Complications|Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)|Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days|||numbers of complications|||Number
43928|NCT01401257|Secondary|To Assess the Plasma Concentrations of PXT3003|PXT3003 plasmatic concentrations after one administration (randomization) and after 1-,6-and 12-months of treatment.|Randomization, 1-, 6- and 12-month treatment||||||
43929|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on a Series of Biochemical Biomarkers|"Dosages of biochemical biomarkers in plasma.~Change from baseline after 3-month of treatment."|Randomization and 3-month treatment||||||
43930|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on Selected Neurophysiological Parameters|"Electrophysiological examination will be performed to assess sensory and motor responses of the median and ulnar nerves (non-dominant side) including: NCV, compound muscle action potential (CMAP) and SNAP.~Change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-month treatment||||||
43931|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on PMP22 mRNA Levels and Intra-epidermal Axon Density in Cutaneous Biopsy|"A cutaneous biopsy (consisting in 2 small punch biopsies) will be performed to assess PMP22 mRNA expression and intra-epidermal axon density.~Change from baseline after 12-month of treatment."|Randomization and 12-month treatment||||||
43932|NCT01401257|Secondary|To Obtain Preliminary Data on the Efficacy of PXT3003 on Clinical Scores and Functional Tests|"Efficacy scores and functional tests will be assessed CMTNS/CMTES:ONLS, VAS, fatigue, pain, six minute walk test (6MWT), nine-hole peg test, quantified muscular testing (QMT; hand grip and foot dorsiflexion), CGI.~For each test or score, change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-months treatment||||||
43933|NCT01401257|Primary|Safety and Tolerability of PXT3003|"The Primary Objective is to assess the clinical and laboratory safety and tolerability of three doses of PXT3003 administered orally for 12 months to CMT1A patients versus placebo.~Number of participants with adverse events in each arm."|Screening, randomization, 1-, 3-, 6-, 9-, 12-month treatment and 1-month follow-up|||Participants|||Count of Participants
43995|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||percentage of blood volume||Standard Deviation|Mean
43934|NCT01401166|Secondary|Participant Satisfaction With Subcutaneous Self-administration Using the Single-use Device|Following the crossover period, participants in Cohort 1 who had at least 2 of the total of 18 treatment cycles remaining, were offered the opportunity to self-administer trastuzumab subcutaneously using the single-use injection device under the supervision of a healthcare provider. Of the ≥ 2 treatment cycles remaining, one was used by the healthcare provider to train the patient. Patients were given an evaluation questionnaire after their first self-administration. Participants answered 5 questions using a 5-item rating scale: Strongly disagree, disagree, unsure, agree, strongly agree. Responses to the 5 questions rated their comfort with self-injection, the convenience of the single-use device, their self-confidence using the single-use device, their satisfaction with the single-use device, and whether they would consider using the single-use device again in the future.|Week 24|Subcutaneous self-administration population: All participants in Cohort 1 who self-administered trastuzumab subcutaneously using the single-use injection device and completed the single-use injection device questionnaire.||Percentage of participants|||Number
43935|NCT01401166|Secondary|Event-free Survival|Event-free survival is defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. As event-free survival is a long-term Outcome Measure and participants have received trastuzumab both intravenously and subcutaneously, the results are presented for all participants as a single group.|Baseline to the end of the study (up to 3 years, 2 weeks)|Intent-to-treat population: All participants who received trastuzumab both intravenously and subcutaneously and who completed the trial-specific telephone interview conducted after the end of the crossover period.||Months||Inter-Quartile Range|Median
43936|NCT01401166|Secondary|Healthcare Practitioners’ Perceived Time to Perform Each Method of Drug Administration|Healthcare professionals were asked to rate the amount of time it took to administer trastuzumab subcutaneously and intravenously in the following time block categories: < 5, 6-10, 11-15, 16-20, > 20 minutes, Not sure, and Unknown. Reported is the percentage of healthcare practitioners who rated the amount of time in each of the categories.|Week 24|Healthcare practitioner population: All healthcare practitioners who participated in the study and completed the healthcare practitioner questionnaire.||Percentage of healthcare practitioners|||Number
43937|NCT01401166|Secondary|Healthcare Practitioners’ Most Satisfied Method of Drug Administration|The method of drug administration with which healthcare practitioners were most satisfied, intravenous or subcutaneous, was assessed at the end of the crossover period by the response to the question in the healthcare practitioner questionnaire “All things considered, with which method of administration were you most satisfied?”. Reported is the percentage of healthcare practitioners who were most satisfied with each method of drug administration.|Week 24|Healthcare practitioner population: All healthcare practitioners who participated in the study and completed the healthcare practitioner questionnaire.||Percentage of healthcare practitioners|||Number
43938|NCT01401166|Primary|Participants’ Preferred Method of Drug Administration|The preferred method of drug administration, intravenous or subcutaneous, was assessed in trial-specific telephone interviews with each study participant conducted after the end of the crossover period. Specifically, the participant was asked “All things considered, which method of administration did you prefer?” Reported is the percentage of participants who preferred each method of drug administration.|Week 24|Intent-to-treat population: All participants who received trastuzumab both intravenously and subcutaneously and who completed the trial-specific telephone interview conducted after the end of the crossover period.||Percentage of participants|||Number
43939|NCT01401153|Primary|Mean Time Incorrect Reactions|Mean time to react incorrectly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Seconds||Inter-Quartile Range|Median
43940|NCT01401153|Primary|Mean Time Correct Reactions|Mean time to react correctly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Seconds||Inter-Quartile Range|Median
43941|NCT01401153|Primary|Incorrect Reactions|Number of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Incorrect reactions||Inter-Quartile Range|Median
43942|NCT01401153|Primary|Number Correct Reactions|Number of correct reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Correct reactions||Inter-Quartile Range|Median
43943|NCT01401153|Primary|Percentage Incorrect Reactions|Percentage of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Incorrect reactions %||Inter-Quartile Range|Median
43944|NCT01401153|Primary|Reactions|Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Total reactions||Inter-Quartile Range|Median
43945|NCT01401153|Primary|Sequencing Errors|Sequences including all the blocks of a prescribed sequence, but in the wrong order|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Sequences with wrong order||Inter-Quartile Range|Median
43946|NCT01401153|Primary|Correct Immediate Block Span|Number of sequences correctly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Sequences correctly reproduced||Inter-Quartile Range|Median
43947|NCT01401153|Primary|Incorrect Immediate Block Span|Number of sequences incorrectly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Sequences incorrectly reproduced||Inter-Quartile Range|Median
43948|NCT01401153|Primary|Immediate Block Span|Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Longest sequence correctly reproduced||Inter-Quartile Range|Median
43949|NCT01401153|Primary|Tonic Alertness (Omission Errors)|Stimuli to which no reaction follows within 1.5s|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Omission errors||Inter-Quartile Range|Median
43950|NCT01401153|Primary|Tonic Alertness (Commission Errors)|Reactions when no stimulus had been presented|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis||Commission errors||Inter-Quartile Range|Median
43955|NCT01401101|Primary|PTSD Symptoms|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|0 months (baseline)|all patients who completed the assessment||CAPS scores||95% Confidence Interval|Mean
43956|NCT01401049|Secondary|To Compare Patient Satisfaction With Sedation Including the Recall of Pain.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours after the end of the procedure.||||||
43957|NCT01401049|Primary|Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours|Due to flooding from Hurricane Sandy at our site, all files and pertinent patient data were lost.|||||
43958|NCT01401023|Primary|Mean (SD) Stool Tigecycline Concentration Level|Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay|day 3 of tigecycline therapy|||micrograms/gram||Standard Deviation|Mean
43959|NCT01401023|Primary|Mean (SD) Serum Tigecycline Concentration Level|Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.|day 3 of tigecycline therapy|||milligram/liter||Standard Deviation|Mean
43960|NCT01401023|Primary|Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates||day 1 stool sample|||milligram/liter||Standard Deviation|Mean
43961|NCT01401023|Primary|Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile|Serum and stool levels of tigecycline|day 3 of treatment||||||
43962|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic area under serum curve of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||milligrams * hour/liters||Standard Deviation|Mean
43963|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic clearance of drug of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||Liters/hour||Standard Deviation|Mean
43964|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic half life of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||hours||Standard Deviation|Mean
43965|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic elimination rate constant of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||hour^-1||Standard Deviation|Mean
43966|NCT01401010|Secondary|Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC))|"Following determination of pharmacokinetic (PK) parameters from patients with febrile neutropenia, Monte Carlo simulations were then conducted to determine time of serum concentrations above the MIC (40% of the time) against Gram-negative isolates.~These Gram-negative isolates had a range of minimum inhibitory concentrations (MIC) to Doripenem."|1, 4, 6, 8 hours after an infusion of doripenem to determine the PK parameters|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||probability of target attainment|||Number
43967|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic volume of distribution of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.||Liters||Standard Deviation|Mean
43968|NCT01400958|Secondary|Occurrence of Improved Cognitive Performance|Determine if Nuvigil® improves cognitive function of patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained average (T=50) to slightly below average (T=40 or greater) cognitive function.|5 months|Available, evaluable participants with average T Score range cognitive function at baseline||participants|||Number
43969|NCT01400958|Primary|Occurrence of Improved Fatigue Experience After Treatment|Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine).|5 months|Available, evaluable participants with minimal fatigue at baseline||participants|||Number
43996|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||ml||Standard Deviation|Mean
43997|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||ml||Standard Deviation|Mean
43970|NCT01400932|Secondary|Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Itching and burning/stinging were evaluated by the participant as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (mild)=noticeable discomfort that caused continuous awareness; 3 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 4 (severe)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
43971|NCT01400932|Secondary|Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Erythema (redness), dryness, and peeling were evaluated independently by the investigator as: 0 (absent)=no erythema, dryness, or peeling; 1 (slight)=faint red/pink coloration, barely perceptible dryness with no flakes or fissure, mild localized peeling; 2 (mild)=light red/pink coloration, perceptible dryness with no flakes/fissure, mild and diffuse peeling; 3 (moderate)=medium red coloration, easily noted dryness and flakes but no fissure, moderate and diffuse peeling; 4 (severe)=beet red coloration, dryness with flakes and fissure, prominent dense peeling. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
43972|NCT01400932|Secondary|Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12|The proportion of participants who have a reduction in total lesions (inflammatory and non-inflammatory) of at least 50% from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
43973|NCT01400932|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
43974|NCT01400932|Secondary|Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Baseline and Week 12|ITT Population. Only those participants with data available at the specified time point were analyzed.||Participants|||Number
43975|NCT01400932|Secondary|Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12|The percent change from Baseline to Weeks 1, 2, 4, 8, and 12 in lesion counts (total [inflammatory and non-inflammatory], inflammatory [IL], and non-inflammatory [NIL]) was analyzed using an ANOVA model with terms for treatment and center. Percent change from Baseline was calculated as: (post-Baseline value minus Baseline value) * 100.|Baseline; Weeks 1, 2, 4 and 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percent change in lesion counts||Standard Error|Least Squares Mean
43976|NCT01400932|Secondary|Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Lesion counts||Standard Error|Least Squares Mean
43998|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||ml||Standard Deviation|Mean
43977|NCT01400932|Secondary|Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, and 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Lesion counts||Standard Error|Least Squares Mean
43978|NCT01400932|Primary|Absolute Change in Total Lesion Counts From Baseline to Week 12|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all randomized participants who received at least one application of investigational product. Only those participants with data available at the specified time point were analyzed. Analysis was based on an analysis of covariance (ANCOVA) model with terms for Baseline value, treatment, and center.||Lesion counts||Standard Error|Least Squares Mean
43979|NCT01400919|Primary|Major Adverse Event Rate||9 months|||percentage of participants|||Number
43980|NCT01400906|Secondary|Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period|Sputum induction was performed using hypertonic saline solution to collect an adequate sample of secretions from lungs. The collected sputum was analyzed for neutrophil and eosinophil counts. Sputum induction was performed after methacholine challenge and post-dose administration on Day 7. Zero values are imputed to 0.001 for this analysis. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.||10^4 cells per gram of sputum||95% Confidence Interval|Geometric Mean
43981|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in WM FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants were non-smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
43982|NCT01400906|Primary|LAR - Smokers: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
43983|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were non-smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
43999|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||ml||Standard Deviation|Mean
51650|NCT01301079|Primary|Pain 60 Minutes|The scale measure pain after 60 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|60 minutes|||units on a scale||Standard Deviation|Mean
43984|NCT01400906|Secondary|Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period|The concentration of eNO was measured on Day 6 pre-dose and on Day 7 post-study medication administration. eNO was measured 3 times at each time point, and all 3 measurements were recorded. The mean of the 3 measurements was calculated and was used in the derivation of summary statistics.|Day 6 and Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.||Parts per billion||Standard Deviation|Mean
43985|NCT01400906|Secondary|Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% decrease in FEV1 from the post-saline value was achieved.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.||milligrams per milliliter||95% Confidence Interval|Geometric Mean
43986|NCT01400906|Secondary|Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline FEV1 was measured on Day 1 pre-dose administration. FEV1 was measured on Day 1 post-dose, on Day 6 (prior to allergen challenge), and on Day 7 pre dose administration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Baseline, Day 1, Day 6, and Day 7|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.||Liters||95% Confidence Interval|Least Squares Mean
43987|NCT01400906|Secondary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes [min], 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs). The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.||Liters||95% Confidence Interval|Least Squares Mean
43988|NCT01400906|Primary|Late Asthmatic Response (LAR) - Smokers: Absolute Change From Saline in Minimum Forced Expiratory Volume in One Second (FEV1) Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (all participants who received at least one dose of study medication) who had a post-dose FEV1 assessment in the same period. Only those participants who were smokers were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
43989|NCT01400880|Primary|Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC|Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.|Stage I and II Labor|Pregnant women between the ages of 18-50 with a single viable fetus in stages I and/or II of labor||seconds||Standard Deviation|Mean
43990|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||l/min/m^2||Standard Deviation|Mean
43991|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||l/min/m^2||Standard Deviation|Mean
43992|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||l/min||Standard Deviation|Mean
43993|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.||l/min||Standard Deviation|Mean
43994|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.||percentage of blood volume||Standard Deviation|Mean
44000|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 3 of 11 participants.||cm||Standard Deviation|Mean
44001|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 5 of 15 participants.||cm||Standard Deviation|Mean
44002|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 7 of 11 participants.||cm||Standard Deviation|Mean
44003|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants.||cm||Standard Deviation|Mean
44004|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 6 of 11 participants.||g||Standard Deviation|Mean
44005|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants||g||Standard Deviation|Mean
44006|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.||mm Hg||Standard Deviation|Mean
44007|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.||mm Hg||Standard Deviation|Mean
44008|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.||mm Hg||Standard Deviation|Mean
44009|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.||mm Hg||Standard Deviation|Mean
44010|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years postprocedure (extended follow-up)|||participants|||Number
44011|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months postprocedure|NYHA evaluation not done on 1 of 15 participants||participants|||Number
44012|NCT01400841|Secondary|Event-free Survival|Event-free survival is defined as survival free from device-related death|6 months postprocedure|||percentage of participants||95% Confidence Interval|Number
44013|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 2 years postprocedure:~Device-related mortality~Complete heart block~Structural device failure~Endocarditis~Periprosthetic leak or dehiscence~Thromboembolism~Bleeding Event~Native Valve Deterioration~Valve Thrombosis~Hemolysis~Reoperation and explant at 2 years"|2 years postprocedure|||percentage of implant procedures||95% Confidence Interval|Number
44014|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 1 month postprocedure:~Device-related mortality~Complete heart block~Structural device failure~Endocarditis~Periprosthetic leak or dehiscence~Thromboembolism~Bleeding Event~Native Valve Deterioration~Valve Thrombosis~Hemolysis~Reoperation and explant at 1 month"|1 month postprocedure|||percentage of implant procedures||95% Confidence Interval|Number
44015|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:~Aortic annular dissection, rupture, or leaflet damage~Paravalvular leak > +2 or requiring intervention~Mitral valve impingement due to implant~implant dehiscence/migration into aorta~implant dehiscence/migration into left ventricle~Hemodynamics requiring intervention~Other adverse event resulting in reoperation, explantation, or permanent disability."|2 years postprocedure (extended follow-up)|||percentage of implant procedures||95% Confidence Interval|Number
44016|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:~Aortic annular dissection, rupture, or leaflet damage~Paravalvular leak > +2 or requiring intervention~Mitral valve impingement due to implant~implant dehiscence/migration into aorta~implant dehiscence/migration into left ventricle~Hemodynamics requiring intervention~Other adverse event resulting in reoperation, explantation, or permanent disability."|discharge or 14 days postprocedure, whichever comes first|||percentage of implant procedures||95% Confidence Interval|Number
44017|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years postprocedure (extended follow-up)|||participants|||Number
44018|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months postprocedure|||participants|||Number
44019|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|2 years postprocedure (extended follow-up)|Extended follow-up participants||percentage of participants||95% Confidence Interval|Number
44020|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|1 month postprocedure|||percentage of participants||95% Confidence Interval|Number
44102|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS||participants|||Number
44021|NCT01400451|Primary|Number of Participants With Hepatic Dose Limiting Toxicities (DLT) in Participants Treated With Concurrent Ipilimumab and Vemurafenib|DLT defined as a >= Grade 3 drug-related AE during induction with ipilimumab in combination with vemurafenib excluding: Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor); Grade 3 cutaneous squamous cell carcinoma; Grade 3 photosensitivity that resolved to a Grade 1 or baseline within 15 days; Grade 3 immune-mediated events of the skin (rash, pruritis) or endocrine systems (hypothyroidism, hyperthyroidism, hypopituitarism, adrenal insufficiency, hypogonadism and cushingoid) that resolved to a Grade 1 or baseline within 28 days; a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Hepatic=elevated aspartate aminotransferase and alanine aminotransferase. Maximum tolerable dose (MTD) was defined as the maximum dose of combination treatment that could be given to 6 subjects such that no more than 2 subjects experience DLT. Day 1=first day of concurrent therapy with ipilimumab and vemurafenib.|Day 1 to last dose of drug + 90 (approximately 2 years)|All participants who received at least one dose of concurrent study drugs.||participants|||Number
44022|NCT01400451|Primary|During the Combination Treatment Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Concurrent Ipilimumab and Vemurafenib|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. AEs: onset on or after ipilimumab start and within 90 days of last dose. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Day 1=first dose of ipilimumab.|Combination drugs: Day 1 to last dose of drug + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.||participants|||Number
44023|NCT01400451|Primary|During the Lead In Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Vemurafenib Alone|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Lead In Period: between the first vemurafenib dose and the day prior to the first ipilimumab dose.|From first vemurafenib dose to day prior to first ipilimumab dose (28 days); Patients who never progressed from Lead-in to combination treatment (720 mg Alone): first dose to last dose + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.||participants|||Number
44024|NCT01400425|Other Pre-specified|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis After Obtaining a Florbetapir F 18 PET Scan.|The impact of a florbetapir F 18 PET scan on a physician's clinical diagnosis of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a florbetapir scan that led to a change in hypothetical clinical diagnosis is presented below.|6 weeks|Subjects who have received a florbetapir scan (either positive or negative).||Percentage of subjects||95% Confidence Interval|Number
44025|NCT01400425|Secondary|Change in Physician Management Plans|Determine the percentage of subjects that had at least one hypothetical change between pre and post scan physician management plans. Change in management is defined as the number of subjects prescribed different item-wise plans at the two assessments divided by the total number of subjects in the population with both a pre and post florbetapir F 18 PET scan physician management plan.|6 weeks|All subjects with progressive cognitive decline who have received a florbetapir scan.||Percentage of subjects||95% Confidence Interval|Number
44026|NCT01400425|Secondary|Change in Confidence of the Clinical Diagnosis|Change in confidence of the clinical diagnosis prior to obtaining a florbetapir F 18 PET scan to the confidence after obtaining a florbetapir F 18 PET scan among subjects in whom the clinical diagnosis remains unchanged. Confidence levels were self-determined by physicians based on their diagnostic certainty and ranged from 0-100%. The mean (SD) change in confidence reflects the average change in diagnostic confidence along the 0-100% scale for the 62 subjects analyzed.|6 weeks|The hypothetical clinical diagnosis remained unchanged in 62 of 229 subjects who received a florbetapir scan.||Percent Change in Confidence||Standard Deviation|Mean
44027|NCT01400425|Other Pre-specified|Item Wise Changes in Physician Management Plan|This outcome analyzed the percentage of subjects who had a hypothetical change in one of the medication or diagnostic categories listed below after receiving a florbetapir scan.|6 weeks|The number of subjects analyzed for each reporting group is determined by scan status. There were 229 total subjects with progressive cognitive decline of whom 113 received a positive florbetapir scan and 116 received a negative florbetapir scan.||Percentage of subjects|||Number
44028|NCT01400425|Secondary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Positive Florbetapir F 18 PET Scan|The impact of a positive florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a positive florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A positive florbetapir PET scan is indicative of moderate to frequent β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|113 out of 229 subjects with progressive cognitive decline received a positive florbetapir scan.||Percentage of subjects||95% Confidence Interval|Number
44029|NCT01400425|Primary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Negative Florbetapir F 18 PET Scan.|The impact of a negative florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a negative florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A negative florbetapir PET scan is indicative of none to sparse β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|116 of 229 subjects with progressive cognitive decline received a negative florbetapir scan.||Percentage of subjects||95% Confidence Interval|Number
44030|NCT01400412|Secondary|Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events|"Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.~See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)"|From study treatment initiation to week 48|All participants who initiated study treatment||participants|||Number
44031|NCT01400412|Secondary|Number of Participants Who Died During the Study||From study treatment initiation to week 48|All participants who started study treatment||participants|||Number
44032|NCT01400412|Secondary|Number of Participants Who Experienced Bone Fractures|Number of participants who experienced bone fractures during the study|From study treatment initiation to week 48|All participants who started study treatment||participants|||Number
44033|NCT01400412|Secondary|Cumulative Probability of Virologic Failure by Week 48|"Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.~Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group."|From study treatment initiation to week 48|All participants who started study treatment||cumulative probability per 100 persons||95% Confidence Interval|Number
44034|NCT01400412|Secondary|Change in Levels of D-dimer From Baseline||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||ng/ml||Inter-Quartile Range|Median
44035|NCT01400412|Secondary|Change in Levels of sCD14 From Baseline|Change in levels of soluble CD14 from baseline|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||pg/ml||Inter-Quartile Range|Median
44036|NCT01400412|Secondary|Change in Levels of sCD163 From Baseline to Week 48|Change in levels of soluble CD163 from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||ng/ml||Inter-Quartile Range|Median
44037|NCT01400412|Secondary|Change in Level of IP-10 From Baseline to Week 48|Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||pg/ml||Inter-Quartile Range|Median
44038|NCT01400412|Secondary|Change in Levels of IL-6 From Baseline to Week 48|Change in levels of Interleukin 6 (IL-6) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||pg/ml||Inter-Quartile Range|Median
44039|NCT01400412|Secondary|Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44040|NCT01400412|Secondary|Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44041|NCT01400412|Secondary|Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44042|NCT01400412|Secondary|Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44043|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44044|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44045|NCT01400412|Secondary|CD8+ T-cell Change From Baseline to Week 48||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||cell/mm^3||Inter-Quartile Range|Median
44046|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 48|Change in CD4 count from baseline (week 0) to week 48|Week 0, week 48|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.||cells/mm^3||Inter-Quartile Range|Median
44047|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 24|Change in CD4 count from baseline (week 0) to week 24|Week 0, week 24|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.||cells/mm^3||Inter-Quartile Range|Median
44048|NCT01400412|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD)|The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44049|NCT01400412|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)|The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|The primary analysis was as-treated which included only participants with total hip BMD measurements available at both week 0 and week 48 who remained on their randomized MVC or TDF component by the time week 48 measurement was taken without an interruption of treatment of more than 10 weeks.||percentage change||Inter-Quartile Range|Median
44050|NCT01400243|Primary|POMS Vigor/Positive Affect (PA)|"Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from 0 (no vigor) to 32 (maximally high vigor score)."|16 days (baseline through day 15 of treatment)|||units on a scale||Standard Error|Mean
44051|NCT01400243|Primary|Marijuana Withdrawal Questionnaire (MWC) Total Score|"The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from 0 = no withdrawal symptoms to 47 = maximally high levels of withdrawal."|16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)|||units on a scale||Standard Error|Mean
44052|NCT01400243|Secondary|Diastolic Blood Pressure (DBP)|Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.|From baseline to Day 15 of abstinence|||mm Hg||Standard Error|Mean
44053|NCT01400243|Secondary|Heart Rate|Heart rate measured during laboratory assessment sessions.|Baseline through Day 15 of abstinence|||beats per minute||Standard Error|Mean
44054|NCT01400243|Secondary|Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.|Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.|across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence|||ng/ml urine creatinine-corrected THC||Standard Error|Mean
44055|NCT01400243|Secondary|Tobacco and Nicotine Intake|Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.|Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.|||Cigarettes per 30 days||Standard Error|Mean
44056|NCT01400243|Secondary|Systolic Blood Pressure (SBP)|Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.|From baseline to Day 15 of abstinence|||mmHg||Standard Error|Mean
44057|NCT01400243|Secondary|Patch Guess and Attributions Questionnaire|The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.|Day 15 of abstinence|||Percentage chance on nicotine patch||Standard Error|Mean
44058|NCT01400243|Primary|Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)|"POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of 0 = best possibly level and a maximum value of 154 = worst possible level."|16 days (prequit baseline and 15 days of abstinence)|||units on a scale||Standard Error|Mean
44059|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part II|The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided.|At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension||||||
44074|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (skin conductance) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||||
44131|NCT01398982|Secondary|Sedation Level|Sedation score in-patient|In Hospital postoperative measures, average 4-5 days||||||
44060|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part I|The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. TSQ - Part I was not administered in the extension period.|At Week 52 or upon early discontinuation at or before Week 4 in maintenance||||||
44061|NCT01400139|Secondary|Patient Global Impression of Change (PGIC)|The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. The proportion of subjects with a response of “much improved” (category 2) and “very much improved” (category 1), is provided along with 95% confidence intervals for the proportion.|At Week 52 in maintenance and at Week 24 in extension||||||
44062|NCT01400139|Secondary|Medical Outcomes Study 36-item Short Form (SF-36)|The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject’s perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. For SF-36, a higher score indicates a better perception of health.|Up to 52 weeks in maintenance and up to 24 weeks in extension||||||
44063|NCT01400139|Secondary|Brief Pain Inventory Short Form (BPI-SF) - Pain Interference|The BPI-SF questionnaire was used to assess the severity of pain and the interference of pain on daily functions. It consists of 9 sections that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Four of the items (questions 3 through 6) assess the severity of pain and 7 items (questions 9A through 9G) assess the interference of pain. The pain severity subscale was determined by calculating the arithmetic mean of the responses to items 3, 4, 5 and 6. For BPI, a lower score indicates a lower pain.|Up to 52 weeks in maintenance and up to 24 weeks in extension||||||
44064|NCT01400139|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep: sleep problems index II and 6 subscale scores – sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For the derived scores in the MOS Sleep-R, a higher score indicates a better sleep pattern.|Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period||||||
44065|NCT01400139|Secondary|"Pain Right Now Score"|"“Pain right now” scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The pain right now scores were only collected during the Core Study. “Pain right now” scores were not assessed during the Extension Period."|Week 12||||||
44066|NCT01400139|Primary|"Daily Average Pain Over the Last 24 Hours"|"Average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks)|The Core Study population analyzed (N=727) was the group of subjects who received at least 1 dose of study drug during the maintenance period. The Extension Period population analyzed (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.||units on a scale||Standard Deviation|Mean
44067|NCT01400139|Primary|The Number of Participants With Adverse Events as a Measure of Safety|Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.|Up to 84 weeks|The Core Study safety population (N=922) was defined as the group of subjects who received at least 1 dose of study drug during the study. The Extension Period safety population (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.||participants|||Number
44068|NCT01400113|Secondary|Clinical Global Impression Scale|Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.|2 hours||||||
44069|NCT01400113|Primary|Positive and Negative Syndrome Scale - Excited Component|The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies.|Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.|||PANSS SCORE||95% Confidence Interval|Mean
44070|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cues|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET|Up to 6 weeks||||||
44071|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Craving|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less craving at the Post-Extinction Assessment than those who receive placebo + CET|Up to 6 weeks||||||
44072|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (electromyogram) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||||
44073|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||||
44075|NCT01399866|Primary|Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.|Participants assigned to receive D-cycloserine + CET will achieve better maintenance of tobacco abstinence, as assessed with self-report and saliva cotinine measurements, than those who receive placebo + CET at week 6 follow up visits|Up to 6 weeks|||percentage of participants|||Number
44076|NCT01399788|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||hr||Full Range|Median
44077|NCT01399788|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.||hr||Standard Deviation|Mean
44078|NCT01399788|Secondary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞][dn]) for Pyrazinamide|AUC [0-∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-∞) divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
44079|NCT01399788|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
44080|NCT01399788|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) for Pyrazinamide|It is obtained from Cmax divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||(ng/mL)/mg||Standard Deviation|Geometric Mean
44081|NCT01399788|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) for Pyrazinamide|AUClast[dn] = Dose normalized area under the plasma concentration-time curve (AUC[dn]) from time zero (pre-dose) to the time of last measured concentration. It is obtained from AUClast divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
44082|NCT01399788|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
44083|NCT01399788|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
44084|NCT01399723|Secondary|Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview|Definition of death as described in third secondary outcome measure.|Day 14|||participants|||Number
44085|NCT01399723|Secondary|Death at or Before Five Days Following Enrollment|Death defined as: in-hospital death occurring at any time after randomisation (recruitment for HIV-exposed participants) or verbal report of death of the enrolled patient from parent/guardian communicated either directly or via telephone conversation.|Day 0 to Day 5||||||
44086|NCT01399723|Secondary|Readmission With Diagnosis of Severe or Very Severe Pneumonia Within 14 Days of Enrollment||Day 0 to Day 14||||||
44087|NCT01399723|Secondary|Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First)|Treatment failure as defined in the primary outcome measure.|Patients will be followed up from the day of hospitalisation (day 0) until the day of medical discharge (average duration of 3 days) or until day 5 of hospitalisation (whichever occurs first).|Intention to treat analysis||participants|||Number
44088|NCT01399723|Primary|Treatment Failure at 48 Hours (Two Full Days After Enrollment)|Development of any signs of very severe pneumonia at any time Hypoxemia defined as SpO2 <85% or <80% for altitude < or ≥1500m respectively measured after minimum of 3 minutes on ambient air Persistent vomiting (occurring within 30 minutes of administration of amoxicillin with failure to retain drug after 3 successive attempts at administration) at any time Clinical diagnosis of new bacterial co-morbid condition requiring revision of antibiotic treatment at any time Lower chest wall indrawing Temperature ≥38◦C Respiratory rate ≥5bpm of admission rate if above age-adjusted normal upper limit|48 hours|Intention to treat analysis||participants|||Number
44132|NCT01398982|Secondary|Postoperative Nausea and Vomiting|Postoperative nausea and vomiting (score of 0-3)|In Hospital postoperative measures, average 4-5 days||||||
44089|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
44090|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
44091|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life.|Week 16 and Week 28|ITT Population; only participants with non missing data were included in the analysis.||units on a scale||Standard Deviation|Mean
44092|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
44093|NCT01399697|Secondary|Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.||units on a scale||Standard Deviation|Mean
44094|NCT01399697|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28|SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI <3.3 = clinical remission.|28 weeks|ITT Population; only participants with SDAI scores at Week 28 were included in the analysis.||percentage of participants|||Number
44095|NCT01399697|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28|CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters [cm]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI <2.8 = clinical remission.|Week 28|ITT Population; only participants with CDAI scores at Weeks 28 were included in the analysis.||percentage of participants|||Number
44096|NCT01399697|Secondary|Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 28|ITT Population; only participants with Week 28 DAS28 values were included in the analysis.||percentage of participants|||Number
44097|NCT01399697|Primary|Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline, Week 16, and Week 28|Intent-to-treat (ITT) population: all randomized participants who received at least one dose of study medication and who had at least one efficacy measurement performed.||units on a scale||Standard Deviation|Mean
44098|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS||participants|||Number
44099|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS||participants|||Number
44100|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.|48 weeks|FAS||participants|||Number
44101|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.|48 weeks|FAS||participants|||Number
44133|NCT01398982|Secondary|Duration of Hospital Stay|Duration of hospital stay (# of days)|In-patient hospital stay, average of 4-5 days||||||
44103|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS||participants|||Number
44104|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no|The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.|48 weeks|FAS||participants|||Number
44105|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes|The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.|48 weeks|FAS||participants|||Number
44106|NCT01399619|Secondary|Early Treatment Success (ETS)|Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8|Week 4, week 8 and week 60|FAS||participants|||Number
44107|NCT01399619|Secondary|Virological Response 24 Weeks Post Treatment (SVR24)|Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.|72 weeks|FAS||percentage of participants||95% Confidence Interval|Number
44108|NCT01399619|Primary|Sustained Virological Response (SVR12)|Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.|60 weeks|FAS||percentage of participants||95% Confidence Interval|Number
44109|NCT01399229|Primary|Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing|Time Stamps of the Peaks of Corresponding Contractions|9 - 41 Minutes|||Seconds||Standard Deviation|Mean
44110|NCT01399190|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to approximately 30 months|Includes enrolled participants eligible for inclusion in the final analysis.||percentage of participants|||Number
44111|NCT01399190|Secondary|Response Rate (Tumor Assessments According to RECIST)|Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR|Up to approximately 30 months|Includes enrolled participants who were evaluable for the primary endpoint analysis.||percentage of participants|||Number
44112|NCT01399190|Primary|Progression-free Survival|Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.|From randomization to progression or death during the study (up to approximately 30 months)|Includes enrolled participants who were evaluable for the primary endpoint analysis.||months||95% Confidence Interval|Median
44113|NCT01399125|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Score|The Mini-Mental State Examination (MMSE) was used to establish patient’s eligibility for the study and it was also used as an efficacy parameter in the Double-blind Treatment Period. The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating betterfunction. The total MMSE score at screening was between 10 and 20, inclusive, in order forthe patient to be eligible to participate in the trial.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||scores on a scale||Standard Deviation|Mean
44114|NCT01399125|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|NPI including Caregiver Distress Scale (NPI-D) assesses a wide range of behavior problems encountered in dementia patients to provide a means of distinguishing frequency and severity of changes in behavioral problems & facilitates rapid behavioral assessment using screening questions.10 behavioral problems & 2 neurovegetative domains were evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency & severity ratings of ea. domain as well as a composite domain score(frequency x severity). Frequency: 1(occasionally) - 4(very frequently)&severity:1(mild) - 3(marked).The sum of the composite scores of the 12 domains yields the NPI total score. The NPI-D: 0(not severe & not at all distressing) - 5 (very severe or extremely distressing) for each of the 12 domains. NPI-12 total score: from 0-144, the NPI-10 total score: from 0-120, & NPI-D score: from 0-60, all with higher scores indicating more severe behavioral disturbance.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||scores on a scale||Standard Deviation|Mean
44134|NCT01398982|Secondary|Quality of Recovery|Quality of Recovery (QOR) score (0-18)|In-patient hospital stay, first post operative 48 hours||||||
44135|NCT01398982|Secondary|Anti-nausea Consumption|Total in-hospital cumulative anti-nausea consumption|In-patient hospital stay, average 4-5 days||||||
44136|NCT01398982|Secondary|First Bowel Movement|Time to first bowel movement (# of days)|In-patient hospital stay, average 4-5 days||||||
44137|NCT01398982|Secondary|Pain Disability|Pain Disability Index Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
44138|NCT01398982|Secondary|Daily Pain Intensity Scores at Rest and With Movement|Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)|In Hospital postoperative measures, average 4-5 days||||||
44139|NCT01398982|Secondary|Total In-hospital Cumulative Opioid Consumption|Total in-hospital cumulative opioid consumption levels|In-patient hospital stay average of 4 - 5 days||||||
44115|NCT01399125|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score|"Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) is a caregiver-based Activities of Daily Living (ADL) scale composed of 23 items developed for use in dementia clinical studies. It was designed to assess the patient’s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item were obtained from the caregiver through an interview. For each basic ADL, there was a forced choice of best response or a yes or no question with additional sub questions. Higher numbered scores and answers of yes reflected a more self-sufficient individual. Therefore, the higher total score, the higher functioning the patient was. The total score was the sum of all items and sub questions. The range for the total ADCS-ADL score was 0 to 78."|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||scores on a scale||Standard Deviation|Mean
44116|NCT01399125|Secondary|Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)|Alzheimer’s disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale provides a single global rating of change from baseline. It was recommended that the baseline interview be conducted by two raters, one designated as the primary rater, the other as a backup. Both raters were independent trained clinicians, experienced in the assessment of patients with dementia. Neither rater was involved in any other way with the patients’ treatment or evaluation throughout the study. At baseline, both raters had access to all of the patient’s available records and evaluations. Subsequently, for all ratings of change from baseline, the rater relied solely on information obtained during the baseline interview of the patient and caregiver, including written notes and, if available, the baseline interview audio- or videotape. The rater had no access to any other safety or efficacy data, including all previous post-baseline ADCS-CGIC ratings by either rater.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||participants|||Number
44117|NCT01399125|Primary|Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)|The Alzheimer’s Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.||Scores on a scale||Standard Deviation|Mean
44118|NCT01399099|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months||||||
44119|NCT01399099|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks||||||
44120|NCT01399099|Secondary|Ease of Use||Up to 12 months||||||
44121|NCT01399099|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months||||||
44122|NCT01399099|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.~[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|12 months|Per protocol, all eligible patients who did not exit the study prematurely.||Units on a scale||Standard Error|Mean
44123|NCT01399047|Secondary|Feasibility of Clinical Trials in Rare Disorder|To pilot the feasibility of conducting controlled clinical trials of this rare neurological disorder base on collaboration between a national center of excellence in the disease (URBC), and children's local care-providers (pediatricians and/or local neurologists.|||||||
44124|NCT01399047|Secondary|Preliminary Evidence of Efficacy|To gather preliminary evidence of the short-term (8 week) impact of mycophenolate mofetil on clinically relevant features of Juvenile Neuronal Ceroid Lipofuscinosis as measured by the Unified Batten Disease Rating Scale, including motor features, seizures, behavior, cognitive and functional measures.|8 week||||||
44125|NCT01399047|Primary|Tolerability|The primary outcome measure is tolerability, defined as the completion of 8 weeks on the assigned dosage of study drug.|8 weeks|||Participants|||Count of Participants
44126|NCT01399008|Primary|Serum Uric Acid|Percent change from baseline in serum uric acid in Per Protocol population|Percent change from baseline in serum uric acid at Week 4|Per Protocol population (all randomized patients who received at least 1 dose of blinded study drug, had at least 1 post-treatment evaluation, had not violated any major entry criterion likely to confound an efficacy analysis and had not deviated significantly from the protocol between enrollment and study completion).||percent change||Standard Deviation|Mean
44127|NCT01398982|Secondary|Time to Ambulation|Time to ambulation (# of days)|In-patient hospital stay, average 4-5 days||||||
44128|NCT01398982|Secondary|Health Related Quality of Life|Short-form health-related quality of life 36 Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
44129|NCT01398982|Secondary|Anxiety and Depression|Hospital Anxiety and Depression Scale Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
44130|NCT01398982|Secondary|Pain Frequency and Intensity|Short-form McGill Pain Questionnaire Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge||||||
44140|NCT01398982|Primary|Mean Total Opioid Consumption|The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.|first postoperative 48 hours|||mg||Standard Deviation|Mean
44141|NCT01398852|Primary|Changes in Corneal Curvature||24 MO|The CXL-003 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.|||||
44142|NCT01398839|Primary|Changes in Corneal Curvature||6 Months|The CXL-002 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.|||||
44143|NCT01398787|Primary|Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)|"The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1)."|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
44144|NCT01398787|Primary|Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)|The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
44145|NCT01398787|Primary|Subjective Rating of Initial Comfort|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Units on a scale||Standard Deviation|Mean
44146|NCT01398787|Primary|Appearance Preference|The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
44147|NCT01398787|Primary|Initial Comfort Preference|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
44148|NCT01398787|Primary|Overall Preference|The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.||Percentage of participants|||Number
44149|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 5).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 5 of the Acquisition Phase."|Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)|||micro-Siemens (square rooted)||Standard Error|Mean
44150|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 4).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 4 of the Early Extinction Phase."|Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)|||micro-Siemens (square rooted)||Standard Error|Mean
44180|NCT01397851|Secondary|Contract Defaults|Defaults on input loans, as defined in the routine data collection system of the participating cotton outgrowing agribusiness. Odds ratios calculated in accordance with NIH guidance: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)|||odds ratio|||Number
44151|NCT01398410|Secondary|Cumulative Recurrent Rate of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.|Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)|The analysis was performed using Full Analysis Set, defined as all participants who received at least one dose of rabeprazole, with at least one post-initiation endoscopic assessment results, and showed no ulcers on baseline endoscopy; excluding participants from the newly-initiated rabeprazole groups of study E3810-J081-309.||Percentage of participants||95% Confidence Interval|Number
44152|NCT01398410|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.|For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)|The analysis was performed using Safety Analysis Set, defined as all participants who received at least one dose of rabeprazole.||Percentage of participants|||Number
44153|NCT01398176|Primary|Physiological Modifications to Gamma Delta T Cell Function|Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T cells express CD3.|4 weeks|Intent to treat||percent of T lymphocytes||Standard Error|Mean
44154|NCT01397890|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||exacerbations/participant/12 weeks||95% Confidence Interval|Least Squares Mean
44155|NCT01397890|Secondary|Change in COPD Symptoms - Sputum|Change in Sputum symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||score on a scale||95% Confidence Interval|Least Squares Mean
44156|NCT01397890|Secondary|Change in COPD Symptoms - Cough|Change in Cough symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||score on a scale||95% Confidence Interval|Least Squares Mean
44157|NCT01397890|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||score on a scale||95% Confidence Interval|Least Squares Mean
44158|NCT01397890|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
44159|NCT01397890|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
44160|NCT01397890|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
44161|NCT01397890|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
44162|NCT01397890|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
44181|NCT01397851|Primary|Cotton Yields|Farmer's cotton yields (kg delivered per household), as defined in the routine data collection system of the participating cotton outgrowing agribusiness|2010-2011 season (up to 1 year)|||kg||Standard Deviation|Mean
44163|NCT01397890|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||times/day||95% Confidence Interval|Least Squares Mean
44164|NCT01397890|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
44165|NCT01397890|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
44166|NCT01397890|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
44167|NCT01397890|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
44168|NCT01397890|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
44169|NCT01397890|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.||L/min||95% Confidence Interval|Least Squares Mean
44170|NCT01397890|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44171|NCT01397890|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44172|NCT01397890|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44173|NCT01397890|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44174|NCT01397890|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44175|NCT01397890|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44176|NCT01397890|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44177|NCT01397890|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.||Ratio||95% Confidence Interval|Geometric Mean
44178|NCT01397851|Secondary|Self-reported Malaria Prevalence|Over two weeks before interview, collected through validation survey. Odds ratio calculated in accordance with NIH guidance http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)|Subset of study population selected for validation survey||odds ratio|||Number
44179|NCT01397851|Secondary|Increase in Maize Productivity|Increase in self-reported maize productivity (yield on maize plots divided by size of maize plots), collected through validation survey; calculated as maize productivity 2010-11 minus maize productivity 2009-10, measured in bags (ordinarily 50kg bags; however, kg measure not specified)|2009-2010 and 2010-2011 seasons (up to 2 years)|Subset of study population selected for validation survey||bags (not further specified)||Standard Error|Mean
44182|NCT01397747|Primary|Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.|An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100*(multitarget DNA or FIT negative test/negative colonoscopy).|90 Days|||percent||95% Confidence Interval|Number
44183|NCT01397617|Secondary|Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intention to treat analysis.||percentage of surviving implants|Participants||Number
44184|NCT01397617|Primary|The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.~Missing data was not imputed and not included in evaluation."|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.||mm||Standard Deviation|Mean
44185|NCT01397591|Secondary|Number of Participants With Adverse Events (Toxicity)|Toxicities and adverse experiences will be assessed at each visit using the NCI Common Toxicity Criteria for Adverse Events v4.0 Interim analyses on toxicity will be implemented based on the toxicity endpoints of the first 6 patients, and will be conducted sequentially 4 weeks after the treatment of each patient, or when serious toxicity has been observed for the patient, whichever comes earlier. we assume a non-informative prior distribution (Beta (0.001, 0.001)) for toxicity rate, and compute the posterior distribution of toxicity rate sequentially.|Days 1, 8, and 15 of each course and 4-6 weeks after final treatment|||participants|||Number
44186|NCT01397591|Secondary|Disease Free Survival|The period of time between complete remission and recurrence of disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.|||||
44187|NCT01397591|Secondary|Progression Free Survival|This outcome measure is defined as the length of time after treatment during which the patient survives with no sign of the disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.|||||
44188|NCT01397591|Secondary|Overall Survival|This outcome measure is defined as the time from initiation of treatment to death due to any cause.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.|||||
44189|NCT01397591|Primary|Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma|Based on International Working Group (IWG) criteria, recorded in four categories: Complete Response (CR), disappearance of all evidence of disease; Partial Response (PR), regression of measurable disease and no new sites of disease; Progressive Disease (PD), Any new lesion or increase by >= 50% of previously involved sites from nadir. Stable Disease (SD), failure to attain CR/PR or PD. A response is defined to be either CR/PR. A failure in response includes SD/PD.|Every 2 cycles during treatment and then every 3 months for 2 years|||participants|||Number
44190|NCT01397461|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.~Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.~The SIRS is a severity index based on seven signs or symptoms:~Exudate/pus~Crusting~Erythema/inflammation~Tissue warmth~Tissue oedema~Itching~Pain~Each sign/symptom is rated on a scale from 0 to 6:~0 = absent~1 2 = mild 3 4 = moderate 5 6 = severe"|2 weeks|||percentage of participants|||Number
44191|NCT01397448|Primary|Cumulative Recurrent Rates of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.|24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.||Events/100 participants/24 weeks||95% Confidence Interval|Number
44192|NCT01397448|Secondary|Cumulative Incidence of Bleeding Ulcers||24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.||Events/100 participants/24 weeks||95% Confidence Interval|Number
44193|NCT01397409|Secondary|Stage 3: Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||letters||Standard Deviation|Mean
44194|NCT01397409|Secondary|Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||microns||Standard Deviation|Mean
44195|NCT01397409|Secondary|Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||letters||Standard Deviation|Mean
44196|NCT01397409|Secondary|Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.||microns||Standard Deviation|Mean
44197|NCT01397409|Secondary|Stage 2: Time Between Second Treatment and Recurrence of Active Disease|Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.|32 Weeks|mITT Population||days||Inter-Quartile Range|Median
44198|NCT01397409|Primary|Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified-Intent-to-Treat (mITT) Population||letters||Standard Deviation|Mean
44199|NCT01397409|Primary|Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease|Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.|Baseline, Week 16|Per-protocol Population included all treated participants who received all scheduled treatments.||days||Inter-Quartile Range|Median
44200|NCT01397409|Primary|Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants.||microns||Standard Deviation|Mean
44201|NCT01397409|Primary|Highest Tolerated Dose (HTD) of AGN-150998|Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.|24 Weeks|Safety population included all treated participants.||mg|||Number
44202|NCT01397253|Secondary|Patient PCP Visits, Emergency Room Visits and Rehospitalizations Within 30 Days Post-discharge.|Details regarding patient PCP follow-up office appointments, ER visits and rehospitalizations occuring within 30 days post-discharge will be collected from the EMR.|Within 30 post-discharge from hospital||||||
44203|NCT01397253|Primary|Medication Errors at Hospital Discharge|Medication name, dose, and frequency of administration for patient pre-admission medications will be recorded. Medications received during the hospitalization and discharge medications will be obtained by medical record review following hospital discharge. Pre-admission medications will be compared to discharge medications and differences will be considered discharge medication variances. Two trained pharmacists will independently review medication variances to determine clinical indications or medication errors.|Approximately 1-30 days|Hospitalized medical patients with ≥2 comorbidities and ≥5 chronic medications, at a single center||Errors|Participants||Number
44204|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 8 weeks|Efficacy Population (104 participants)||Participants|||Number
44205|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks.|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.||Participants|||Number
44206|NCT01397084|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.||Days with heartburn||Standard Deviation|Mean
44207|NCT01397084|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline and 8 weeks|Efficacy Population (104 participants)||Days with heartburn||Standard Deviation|Mean
44208|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44209|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44210|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44211|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44212|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44213|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44214|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44215|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44216|NCT01396525|Secondary|Stent Thrombosis|Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target lesions|Participants|95% Confidence Interval|Number
44217|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
44218|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
44219|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
44220|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint||percentage of target limbs|Participants||Number
44221|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44222|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44223|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|18 months|ITT population.This analysis represents those subjects who were event free at this timepoint||percentage of particpants|||Number
44224|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this timepoint||percentage of particpants|||Number
44225|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
44226|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
44227|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of target limbs|Participants||Number
44228|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint||percentage of target limbs|Participants||Number
44229|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44230|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44231|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44232|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint||percentage of participants|||Number
44233|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44234|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|2 years|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44235|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
44236|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint.||percentage of participants|||Number
44237|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
44238|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
44239|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
44240|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|3 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
44241|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|2 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
44242|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
44243|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
44244|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
44245|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
44246|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
44247|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.||percentage of limbs|Participants||Number
44248|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.||percentage of target vessels|Participants||Number
44249|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.||percentage of target vessels|Participants||Number
44280|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44250|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint||percentage of target vessels|Participants||Number
44251|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint||percentage of target vessels|Participants||Number
44252|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.||percentage of target vessels|Participants||Number
44253|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.||percentage of target vessels|Participants||Number
44254|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.||percentage of target vessels|Participants||Number
44255|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint||percentage of target vessels|Participants||Number
44256|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
44257|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
44258|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
44259|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
44260|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
44261|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
44262|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.||percentage of target lesions|Participants||Number
44263|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
44264|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44265|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44266|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44267|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44268|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44269|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44270|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44271|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44272|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of target limbs|Participants||Number
44273|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44274|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44275|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44276|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
44277|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|Pre-procedure|ITT population, per subject analysis||score on a scale||Standard Deviation|Mean
44278|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44279|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44281|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between Baseline and 1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44282|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and Post-procedure|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44283|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44284|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44285|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44286|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44287|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44288|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
44289|NCT01396525|Secondary|Procedure Success|Procedure success is defined as technical success (device success and attainment of a final residual stenosis of < 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population, per subject analysis||percentage of participants||95% Confidence Interval|Number
44290|NCT01396525|Secondary|Technical Success|Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of < 30% by QA or as reported by the investigator.|Acute: from beginning of index procedure to end of procedure|ITT population, per lesion analysis||percentage of target lesions|Participants|95% Confidence Interval|Number
44291|NCT01396525|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|Acute: from beginning of index procedure to end of procedure|ITT population, per device analysis. Included 210 stents plus 1 stent inserted but not implanted due to device malfunction, 2 stents excluded due to inappropriate sizing (stents were not implanted), 1 stent excluded as stent was not implanted per physician's choice and had no device malfunction.||percentage of devices|Participants|95% Confidence Interval|Number
44292|NCT01396525|Primary|Major Adverse Event (MAE)|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants||95% Confidence Interval|Number
44293|NCT01396512|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
44294|NCT01396512|Secondary|Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.||Participants|||Number
44295|NCT01396512|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|"Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).~JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)"|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
44296|NCT01396512|Primary|Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.|Day 28 post-vaccination|Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.||Percentage of Participants|||Number
44297|NCT01396434|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.|Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period|Participants who received at least 1 dose of 13vPnC.||participants|||Number
44298|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score|The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety [G2], guilt feelings [G3], tension [G4], depression [G6]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44299|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score|The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement [P4], hostility [P7], uncooperativeness [G8], poor impulse control [G14]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44300|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score|The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization [P2], difficulty in abstract thinking [N5], mannerisms and posturing [G5], disorientation [G10], poor attention [G11], disturbance of violation [G13], preoccupation [G15]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44301|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score|The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect [N1], emotional withdrawal [N2], poor rapport [N3], passive/apathetic social withdrawal [N4], lack of spontaneity and conversation flow [N6], motor retardation [G7], active social avoidance [G16]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44302|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score|The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions [P1], hallucinatory behaviour [P3], grandiosity [P5], suspiciousness [P6], stereotyped thinking [N7], somatic concern [G1], unusual thought content [G9], lack of judgment and insight [G10]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44303|NCT01396421|Secondary|Discontinuation Rate for Lack of Efficacy at Week 6||Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Percentage of participants|||Number
44352|NCT01396226|Secondary|PR Interval|Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
51651|NCT01301079|Primary|Pain 30 Minutes|The scale measure pain after 30 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|30 minutes|||units on a scale||Standard Deviation|Mean
44304|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score|The PEC consists of 5 PANSS items (excitement [P4], hostility [P7], tension [G4], uncooperativeness [G8], and poor impulse control [G14]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44305|NCT01396421|Secondary|Response Rate at Week 6|Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Percentage of participants|||Number
44306|NCT01396421|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6|The participant’s overall improvement was rated using the CGI-I. The rater or study physician rated the participant’s total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant’s condition at screening/baseline. Response choices were: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
44307|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score|For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44308|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score|For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44309|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)|The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 122, 55 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44310|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|The severity of illness was rated using the CGI-S. To perform this assessment, the rater or study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.|Baseline to Week 1, 2, 3, 4 and 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44311|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 1, 2, 3, 4, 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44353|NCT01396226|Secondary|HV Interval|Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44312|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 124, 56 and 109 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44313|NCT01396421|Primary|Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 134, 132, 62 and 124 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.||Units on a scale||Standard Error|Least Squares Mean
44314|NCT01396395|Secondary|Number of Subjects Who Showed Compliance to Nicorandil|Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated.|Baseline up to 12 Weeks|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.||subjects|||Number
44315|NCT01396395|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.||subjects|||Number
44316|NCT01396395|Secondary|Walk Distance in Six Minute Walk (6-MWT) Test at Week 12|The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.||meters||Standard Deviation|Mean
44317|NCT01396395|Secondary|Number of Nitroglycerin Tablets Consumed in a Week||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||tablets per week||Inter-Quartile Range|Median
44318|NCT01396395|Secondary|Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||subjects|||Number
44319|NCT01396395|Secondary|Frequency of Angina Attack|The total number of times angina attacks occurred within a week (number of times/week)|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||angina attacks per week||Inter-Quartile Range|Median
44320|NCT01396395|Secondary|Number of Subjects Experienced Angina Attack||Baseline up to 12 Weeks|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||subjects|||Number
44321|NCT01396395|Secondary|ECG QT Dispersion|The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12‐lead ECG.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||milliseconds||Standard Deviation|Mean
44322|NCT01396395|Secondary|Number of Arrhythmia Occurred Within 24 Hours|The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||beats per 24 hours||Standard Deviation|Mean
44323|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on ‘normal-to-normal’ (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||millisecond square (ms^2)||Standard Deviation|Mean
44324|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Time Domain|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on ‘normal-to-normal’ (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means.|At Week 12|"FAS included all randomized subjects who received at least one dose of study treatment. n signifies the number of subjects evaluable for each category in each group for this outcome measure, respectively."||millisecond||Standard Deviation|Mean
44325|NCT01396395|Secondary|Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test|The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||percentage of subjects|||Number
44326|NCT01396395|Secondary|Change From Baseline in Longest Duration of ST Segment Depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||seconds||Standard Deviation|Mean
44327|NCT01396395|Secondary|Change From Baseline in Maximum ST-depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||millimeter||Standard Deviation|Mean
44328|NCT01396395|Secondary|Change From Baseline in Total Myocardial Ischemic Burden at Week 12|The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.||millimeter*minutes||Standard Deviation|Mean
44329|NCT01396395|Primary|Number of Myocardial Ischemia Attacks in 24 Hours|Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (>=) 0.1 millivolts (mV), and lasted for >= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.||ischemic attacks per 24 hours||Standard Deviation|Mean
44330|NCT01396382|Primary|Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan|Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).|at 1 year|A major change in management is defined as:planned surgery cancelled, added, or a different type of surgery was planned, or a medication was added or stopped, or a new treatment modality (e.g. radiation) was added. A minor change was adjustment to planned surgery or radiation field, or in current medication dosage.||participants|||Number
44331|NCT01396382|Secondary|Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability|Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life‐threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.|at 1 year|||participants|||Number
44332|NCT01396265|Secondary|Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)|V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||Litres||Geometric Coefficient of Variation|Geometric Mean
44333|NCT01396265|Secondary|Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)|CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||mL/min||Geometric Coefficient of Variation|Geometric Mean
44334|NCT01396265|Secondary|Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo)|MRTpo represents the mean residence time of the analyte in the body after oral administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||hours||Geometric Coefficient of Variation|Geometric Mean
44335|NCT01396265|Secondary|Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞)|%AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||percentage of AUCtz-∞||Geometric Coefficient of Variation|Geometric Mean
44336|NCT01396265|Secondary|Area Under Curve From 0 to 24 h (AUC0-24)|AUC0-24 represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (h)|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
44337|NCT01396265|Secondary|Terminal Half-life of Afatinib in Plasma (t1/2)|t1/2 represents the terminal half-life of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||hours||Geometric Coefficient of Variation|Geometric Mean
44338|NCT01396265|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)|tmax represents the time from dosing to the maximum concentration of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||hours||Full Range|Median
44339|NCT01396265|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
44340|NCT01396265|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
44341|NCT01396265|Primary|Area Under Curve From 0 to Infinity Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
44342|NCT01396239|Post-Hoc|Frequency of AEs Related to Eteplirsen|Frequency of AEs that the study physician considered to be any of the following: Related; Possibly related; or Probably related to eteplirsen.|24 Weeks|||Number of patients|||Number
44343|NCT01396239|Post-Hoc|Adverse Events >30%|Adverse events that occurred in >30% of the overall patient population across treatment arms.|24 Weeks|||Number of patients|||Number
44344|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Modified Intent to Treat Population (mITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment of the 6-MWT distance. Change from baseline: 6 Minute Walk Test (6MWT) - modified Intent-to-Treat population (mITT).|24 weeks|The mITT population excludes 2 patients in the 30mg/kg arm who showed rapid disease progression within weeks of enrollment, and were unable to complete assessments that required ambulation at or beyond Week 24.||Meters||Standard Error|Mean
44345|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Intent to Treat Population (ITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment Change from baseline: 6 Minute Walk Test (6MWT) - Intent to Treat population (ITT)|24 weeks|||Meters||Standard Error|Mean
44346|NCT01396239|Primary|Change in the Number (%) of Dystrophin Positive Fibers|The primary efficacy endpoint will be based on the pre-treatment and post-treatment change in the number (%) of dystrophin positive fibers as measured in the muscle biopsy tissue on immunohistochemistry (IHC).|After 12 weeks for 4 patients who received 50 mg/kg and 2 patients who received placebo. After 24 weeks for 4 patients who received 30 mg/kg and 2 patients who received placebo.|The sample size for the study was selected based on Proof of Principal approach.||percentage of dystrophin Pos. fibers||Full Range|Least Squares Mean
44347|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|PP||msec||Standard Deviation|Mean
44348|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|PP||msec||Standard Deviation|Mean
44349|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Per Protocol (PP)||msec||Standard Deviation|Mean
44350|NCT01396226|Secondary|RR Interval|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44351|NCT01396226|Secondary|QRS Duration|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44354|NCT01396226|Secondary|AH Interval|Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44355|NCT01396226|Secondary|PA Interval|Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44356|NCT01396226|Secondary|Atrio-ventricular Effective Refractory Period|Change from observation before IP infusion to during 1st and 2nd LAERP Mean|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44357|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44358|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|FAS||msec||Standard Deviation|Mean
44359|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Full A analysis Set (FAS)||msec||Standard Deviation|Mean
44360|NCT01396187|Secondary|Average Plasma Concentration (Cav) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Geometric Mean
44361|NCT01396187|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Geometric Mean
44362|NCT01396187|Secondary|Volume of Distribution of PF-05231023 at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. PF-05231023 with C-terminal and N-terminal Vss at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."||liter||Standard Deviation|Geometric Mean
44363|NCT01396187|Secondary|Apparent Clearance (CL) of PF-05231023 at Steady State|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants who received PF-05231023 with C-terminal and N-terminal CL at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||liter per hour||Standard Deviation|Geometric Mean
44364|NCT01396187|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023 at Steady State|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."||hour||Standard Deviation|Mean
44365|NCT01396187|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF- 05231023|Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 25) divided by Cmax at first dose (Day 1). Participants who received PF-05231023 with C-terminal and N-terminal Rac,Cmax at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ratio||Standard Deviation|Geometric Mean
44366|NCT01396187|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval of PF-05231023 (Rac)|Rac was obtained from AUCtau at steady state (Day 25) divided by AUCtau after single dose (Day 1). AUCtau was the area under the concentration-time profile from time zero to end of dosing interval, where tau = 72 hours for Day 1 and tau = 96 hours for Day 25. Participants who received PF-05231023 with C-terminal and N-terminal Rac at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ratio||Standard Deviation|Geometric Mean
44367|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Geometric Mean
44368|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Tmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hour||Full Range|Median
44369|NCT01396187|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05231023 at Steady State|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. Participants who received PF-05231023 with C-terminal and N-terminal AUClast at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Geometric Mean
44370|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Geometric Mean
44371|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Participants who received PF 05231023 with C-terminal and N-terminal Cmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
44372|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.||hour||Full Range|Median
44373|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|Pharmacokinetic (PK) parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
44374|NCT01396187|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6* LLN or >1.5* ULN.|Baseline up to Day 32|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
44375|NCT01396187|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
44376|NCT01396187|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mm Hg), supine diastolic BP (DBP) <50 mm Hg, supine pulse rate <40 beats per minute (bpm), > 120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mm Hg and maximum increase or decrease from baseline in supine DBP >=20 mm Hg.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
44377|NCT01396187|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities were reported.|Baseline up to Day 42|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
44378|NCT01396187|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 77 which were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
44550|NCT01393106|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|ITT Analysis Set||months||95% Confidence Interval|Median
44379|NCT01396187|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure, pulse rate and body temperature. Criteria for abnormal physical findings was based on investigator’s discretion and were reported as adverse event (AE), as planned.|Baseline up to Day 42|Physical examination data reported in this study was for identification of adverse events and were reported as adverse event in the AE section.|||||
44380|NCT01396161|Secondary|Urinary Recovery|Percentage of PF-05175157 excreted unchanged in urine over the dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||percentage||Standard Deviation|Mean
44381|NCT01396161|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|It was not possible to calculate data for half-life as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the half-life.|||||
44382|NCT01396161|Secondary|Renal Clearance (CLr)|CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||mL/min||Standard Deviation|Mean
44383|NCT01396161|Secondary|Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)|Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]).|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||ratio||Standard Deviation|Mean
44384|NCT01396161|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data||µg times (*)hr divided by mL (µg *hr/mL)||Standard Deviation|Mean
44385|NCT01396161|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Parameter (PKP) Analysis Population: all enrolled participante who received at least 1 dose of PF05175157 and had at least 1 PKP of interest calculated;Number of Participants Analyzed (N): number of participants with evaluable data||hours (hrs)||Full Range|Median
44386|NCT01396161|Secondary|Maximum Observed Plasma Concentration (Cmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Concentration (PKC) Analysis Population: all enrolled participants who received at least 1 dose of PF-05175157 and had at least 1 concentration value reported. Number of Participants Analyzed (N): number of participants with evaluable data||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
44387|NCT01396161|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|2 weeks|Safety Analysis Set: all participants who received at least 1 dose of study medication (PF-05175157 or placebo).||participants|||Number
44388|NCT01396083|Secondary|Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline|The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment||Participants|||Number
44389|NCT01396083|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis||Units on a scale||Standard Deviation|Mean
44390|NCT01396083|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.||Units on a scale||Standard Deviation|Mean
44391|NCT01396083|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Score on a scale||Standard Deviation|Mean
44551|NCT01393106|Secondary|Overall Survival|Overall survival was defined as the time from start of idelalisib treatment to death from any cause.|Up to Week 110|ITT Analysis Set||months||95% Confidence Interval|Median
44552|NCT01393106|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.|Up to Week 110|Responding Analysis Set||months||Full Range|Median
44392|NCT01396083|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||µm||Standard Deviation|Mean
44393|NCT01396083|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||letters||95% Confidence Interval|Least Squares Mean
44394|NCT01396083|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Time to event (Days)||95% Confidence Interval|Median
44395|NCT01396083|Secondary|Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Participants|||Number
44396|NCT01396083|Secondary|Mean BCVA Change at Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||95% Confidence Interval|Least Squares Mean
44397|NCT01396083|Primary|Mean Average BCVA Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||Standard Deviation|Mean
44398|NCT01396057|Secondary|Rate of the Internal Ocular Pressure (IOP)|The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment||Participants|||Number
44399|NCT01396057|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis||Units on a scale||Standard Deviation|Mean
44400|NCT01396057|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.||Units on a scale||Standard Deviation|Mean
44401|NCT01396057|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Score on a scale||Standard Deviation|Mean
44402|NCT01396057|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||µm||Standard Deviation|Mean
44403|NCT01396057|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||95% Confidence Interval|Least Squares Mean
44404|NCT01396057|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Time to event (Days)||95% Confidence Interval|Median
44405|NCT01396057|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Participants|||Number
44406|NCT01396057|Secondary|Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters (EDTRS)||95% Confidence Interval|Least Squares Mean
44407|NCT01396057|Primary|Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned||Letters||Standard Deviation|Mean
44408|NCT01396044|Secondary|Standardized Mortality Ratio||Hospital admission|All patients treated with at least one day of empirical antibiotics.||observed/expected deaths||95% Confidence Interval|Mean
44409|NCT01396044|Secondary|Proportion of Patients-days on Which Empirical Antibiotics Were Used|Proportion of patients-days on which empirical antibiotics were used|ICU admission|All patients who received at least one day of empirical antibiotics.||Number of patient-days|||Number
44410|NCT01396044|Secondary|Proportion of Successful Prompts|"Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred~Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed"|During ICU admission, an average of 5 days (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.||proportion of patient-days|||Number
44411|NCT01396044|Secondary|Ventilator-free Days|Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.|During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.||days||Inter-Quartile Range|Median
44412|NCT01396044|Secondary|Length of Stay||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.||days||Inter-Quartile Range|Median
44413|NCT01396044|Secondary|Hospital Mortality||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirican antibiotics during ICU admission||number of deaths|||Number
44414|NCT01396044|Primary|Proportion of Empiric Antibiotics|The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).|ICU admission|All patients who received at least one day of empirical antibiotics during their ICU admission.||proportion of antibiotic-days||Standard Deviation|Mean
44415|NCT01396044|Primary|Empiric Antibiotic Duration||During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)|All patients who received at least one day of empirical antibiotics during their ICU admission.||days||Inter-Quartile Range|Median
44416|NCT01396005|Secondary|Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued on Day 6.||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
44553|NCT01393106|Secondary|Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)||Up to Week 110|An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples.|||||
44417|NCT01396005|Secondary|AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
44418|NCT01396005|Primary|Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued from study on Day 6.||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
44419|NCT01396005|Primary|AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
44420|NCT01396005|Primary|Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
44421|NCT01396005|Primary|Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir||(ng.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
44422|NCT01395966|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study ( up to 22 days)|||days||95% Confidence Interval|Median
44423|NCT01395901|Secondary|Proportion of Patients Without Nausea (Patient Aged > 6 Years)||0-24 hours after T0|The Full Analysis Set (FAS) population aged ≥ 6 years||percentage of patients||95% Confidence Interval|Number
44424|NCT01395901|Secondary|Proportion of Patients Without Antiemetic Rescue Medication|Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
44425|NCT01395901|Secondary|Proportion of Patients Without Emetic Episodes|An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
44426|NCT01395901|Secondary|Proportion of Patients With no Vomiting|Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.||percentage of patients||95% Confidence Interval|Number
44427|NCT01395901|Primary|Proportion of Patients With Complete Response|Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) included all randomized patients who received the active study drug, general anesthesia and surgery (evaluable patients). Following the intent-to-treat principle, patients were assigned to the study treatment arm according to their randomized treatment.||percentage of patients||95% Confidence Interval|Number
44428|NCT01395888|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of Eh/2pR, where E is Young’s modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and p is the blood density. Change from Baseline was calculated as the Day 84 value minus the Baseline value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking status at screening, geographical region, Baseline aPWV, and interaction terms of Baseline by visit and treatment by visit.|Baseline to Day 84 (Early Withdrawal)|Intent-to-Treat (ITT) Population: all participants (par.) who were randomized to and received >=1 dose of randomized medication in the TP. The analysis model included all par. in the ITT Population without missing covariate information (MCI) and with >=1 post-BL measurement. Par. presented represent those with data available at Day 84 without MCI.||meters per second (m/sec)||Standard Error|Least Squares Mean
44429|NCT01395823|Primary|EPO Dose|The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.|Baseline, 6 months|||units/week||Inter-Quartile Range|Median
44430|NCT01395784|Secondary|Analgesic Responses Using the Cold Pressor Test|Latency to withdraw hand from cold water during the cold pressor test.|Measured during the lab session conducted at the end of each maintenance period|||seconds||Standard Deviation|Mean
44431|NCT01395784|Primary|"Subjective Ratings of Good Drug Effect"|Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)|Measured during the lab session conducted at the end of each maintenance period|Shown below are peak drug effects from each of the 3 maintenance periods (Placebo, Pioglitazone (PIO) 15, and PIO 45)||units on a scale||Standard Deviation|Mean
44432|NCT01395524|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Participants|||Number
44433|NCT01395524|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Participants|||Number
44434|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat (ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.The N denotes the number of patients with a baseline and last on-treatment value.||units on a scale||Standard Deviation|Mean
44435|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat(ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The N denotes the number of patients with a baseline and last on-treatment value.||units on a scale||Standard Deviation|Mean
44436|NCT01395524|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Participants|||Number
44437|NCT01395394|Primary|C-Reactive Protein (CRP)|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|CRP will be measured every other hour for six hours at baseline (study visit 1) for all study groups and again during a second visit 2 weeks after baseline in BH4 Non-Responders only (study visit 2)|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. CRP was measured in 10 subjects - data were unavailable for 1 control participant due to inadequate sample volume.||mg/dl||Standard Deviation|Mean
44438|NCT01395394|Primary|Lipid Peroxidation|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|Lipid peroxidation will be measured every other hour for six hours at baseline (study visit 1) for all study groups|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. TBARS was measured in 3 BH4 responders only - data were unavailable for 8 other participants (2 responders, 3 non-responders, and 3 controls) due to inadequate sample volume.||umole/L||Standard Deviation|Mean
44439|NCT01395368|Primary|Brain Speed Test|Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.|Participants completed brain speed test on the same day as enrollment. No follow-up required.|Number of participants who completed the study with the exception of 4 subjects whose data was excluded due to the fact that they were younger than the the normative age-specific data available and BST Z-scores were not able to be calculated.||z-score||95% Confidence Interval|Mean
44440|NCT01395277|Secondary|Pulse Wave Velocity / Arterial Stiffness|Assessment of pulse wave velocity in the common carotid artery and the femoral artery provides an index of arterial stiffness.|Prior to (baseline) and 2 hours following beverage consumption|||cm / sec||Standard Deviation|Mean
44441|NCT01395277|Primary|Cutaneous Blood Flow Response to Local Heating of the Skin.|Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.|prior to (baseline) and 2 hours post beverage consumption|||percent change in mean skin blood flow||Standard Deviation|Mean
44442|NCT01395043|Primary|Postoperative Pain Using Numerical Rating Scale (NRS) 0-10|"NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain.~NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing."|0-36 hours postoperative|||Units on Numerical Rating Score||Inter-Quartile Range|Median
44443|NCT01395043|Secondary|Opioid Requirements Postoperative|Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine.|48 hours from arriving in the post anesthesia care unit.|||mg iv morphin equivalent||95% Confidence Interval|Mean
44444|NCT01395017|Secondary|Progression Free Survival (PFS)|PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.|Time from randomization to earliest PFS event by 02 December 2013|The ITT data which was composed of all randomized participants.||Days||95% Confidence Interval|Median
44445|NCT01395017|Primary|Overall Survival|Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.|From randomization until date of death from any cause by 02 December 2013|The intent-to-treat (ITT) data which was composed of all randomized participants.||Days||95% Confidence Interval|Median
44446|NCT01394991|Secondary|Red Blood Cell Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.||participants|||Number
44447|NCT01394991|Secondary|Number of Hemoglobin Responders|Hemoglobin response was defined as a hemoglobin increase of ≥2 g/dL from baseline or reaching a hemoglobin concentration of 12 g/dL, regardless of dose adjustment.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.||participants|||Number
44448|NCT01394991|Secondary|Mortality|Number of participants who died during the study.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
44449|NCT01394991|Secondary|Time to First Suspected Thrombovascular Event|Analysis of time to first suspected thrombovascular event (TVE) measured from the date of randomization to the date of the first suspected TVE during the study. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
44450|NCT01394991|Secondary|Number of Suspected Thrombovascular Events|Number of participants who have at least 1 suspected thrombovascular events (TVEs) during the entire study. Suspected TVEs were defined as suspected TVEs during the entire study, whether clinically relevant and objectively confirmed by the Adjudication Committee or not, whether confirmed by the investigator or not.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
44451|NCT01394991|Secondary|Time to First Positively Adjudicated Thrombovascular Event|Analysis of time to first positively adjudicated thrombovascular event (TVE) measured from the date of randomization to the date of the first clinically relevant and objectively confirmed TVE as determined by the Adjudication Committee. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
44452|NCT01394991|Secondary|Number of Positively Adjudicated Thrombovascular Events|The number of participants who have at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) during the study.|during the study (randomization through week 26)|The modified intent-to-treat (mITT) population used for safety analysis population included all randomized participants who received at least 1 dose of study drug.||participants|||Number
44453|NCT01394991|Primary|Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16|Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests.|from randomization through Week 16|The modified intent-to-treat (mITT) population was defined to include all randomized participants who received at least 1 dose of study drug.||particpants|||Number
44454|NCT01394926|Secondary|Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group.|Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison , this study was stopped prematurely. No efficacy analyses were performed.|||||
44455|NCT01394926|Primary|Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.|Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison, this study was stopped prematurely. No efficacy analyses were performed.|||||
44456|NCT01394718|Secondary|Average Pruritus Score|Pruritus scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Pruritus scores range from 1 (none) to 3 (intolerable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo||units on a scale||Full Range|Median
44457|NCT01394718|Secondary|Average Nausea Score|Nausea scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Nausea Scores range from 1 (none) to 4 (severe).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo||units on a scale||Full Range|Median
44458|NCT01394718|Secondary|Average Pain Score|Pain Scores were monitored using the numeric pain assessment scale in both treatment arms of the study and recorded and averaged for the first 24 hours after initial intra-operative dose of study drug. The numeric pain assessment scale is a verbal self-reported pain assessment that ranges between 1 (no pain) to 10 (worst pain imaginable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo||units on a scale||Standard Deviation|Mean
44459|NCT01394718|Primary|Total Opiate Requirement|Total opiate requirement was monitored 24 hours post-operatively. Morphine and hydromorphone measurements were totaled and recorded in mg/kg/day of morphine equivalents.|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo.||mg/kg||Standard Deviation|Mean
44460|NCT01394692|Secondary|Neurological Deficit|Assessment of new postoperative deficits following tumor surgery|7 days||||||
44461|NCT01394692|Secondary|Volumetric Assessment|Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI|72 hours||||||
44462|NCT01394692|Secondary|Progression-free Survival|Progression-free survival (radiological and/or clinical progression) at 6 months following surgery|6 months||||||
44463|NCT01394692|Primary|Extent of Resection|Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved|72 hours|Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.||participants|||Number
44464|NCT01394614|Primary|Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine|Incidence rates will be computed by comparing narcolepsy incidence rates in exposed and non-exposed subjects. Comparison of narcolepsy incidence rates in the period prior to vaccine administration and pseudo-vaccine administration will be used to test the comparability of exposed and non-exposed group.|Narcolepsy onset during the 16-week post-vaccination period.|||events per 100,000 person-years|||Number
44465|NCT01394510|Secondary|Oral Disposition Index|The change in the oral disposition index defined was the change in the early insulin response divided by the change in glucose from 0-30 minutes during the oral glucose tolerance test divided by fasting insulin.|4 weeks|||mg/dl||Standard Deviation|Mean
44466|NCT01394510|Secondary|Area Under the Curve for Glucose (AUCg)|Change in AUCg from 0-120 minutes during the oral glucose tolerance test at 4 weeks compared to baseline|4 weeks|||mg/dl x 120 minutes||Standard Deviation|Mean
44467|NCT01394510|Primary|Fasting Urine F2 Alpha Isoprostane Levels|Change in fasting urine isoprostane levels at 4 weeks vs baseline as a marker of oxidative stress|4 weeks|Change in urine F2 alpha isoprostanes/mg urine creatinine. Urine isoprostanes were only measured in a subset of participants due to lack of effect of the intervention on glucose tolerance.||ng/ml||Standard Deviation|Mean
44508|NCT01393899|Secondary|CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS||Score on a scale||Standard Deviation|Mean
44468|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The HAQ is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). Data allowing the evaluation of HAQ was available for 73 participants in DMARD-IR group and 157 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The “n” represents the number of participants analyzed at a specified time point.||units on a scale||Standard Deviation|Mean
44469|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|VAS for fatigue is a 100 mm scale for participant’s assessment of their current level of fatigue: 0 mm corresponds to “no perception of fatigue”; 100 mm is the “maximum that may be perceived”. The mean VAS fatigue scores were evaluated after the first infusion of TCZ in two different sub populations, classified according to the previous pharmacological treatment: participants with inadequate response to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of fatigue (VAS) was available for 45 participants in DMARD-IR group and 113 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."||units on a scale||Standard Deviation|Mean
44470|NCT01394276|Secondary|Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The DAS28 index applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints) 3. ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. The mean DAS28 scores were evaluated after the first infusion of TCZ in two different sub populations: participants with inadequate response (IR) to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of DAS28 was available for 81 participants in DMARD-IR group and 203 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."||units on a scale||Standard Deviation|Mean
44471|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.|The presence and severity of SH and JE of third MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
44472|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand|The presence and severity of SH and JE of second MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of second MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
44473|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of SH and JE of third MCP joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of right hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intraarticular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
44518|NCT01393743|Secondary|50% Responder Rate for Primary Generalized Seizure Subtype During Maintenance-LOCF (for Core Study)|Primary generalized seizure subtype includes absence and myoclonic seizures. A responder is a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance-(last observation carried forward LOCF) from prerandomization. The data is presented as percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set||Percentage of participants|||Number
44474|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of synovial hyperplasia (SH) and joint effusion (JE) of second metacarpo-phalangeal (MCP) joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, synovial hyperplasia and joint effusion were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
44475|NCT01394276|Secondary|Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion|Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||percentage of participants|||Number
44476|NCT01394276|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
44477|NCT01394276|Secondary|Percentage of Participants Discontinuing Treatment With Tocilizumab|The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||percentage of participants|||Number
44478|NCT01394276|Secondary|Number of Participants With Concomitant Medications|Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.||participants|||Number
44479|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab|The health assessment questionnaire (HAQ) is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, the participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score of minimum/maximum i.e., 0 (best) to 3 (worst).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of HAQ was available for 66 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.||units on a scale||Standard Deviation|Mean
44480|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab|VAS for fatigue is a 100 mm scale for participant’s assessment of their current level of fatigue. The ‘0 ‘mm corresponds to “no perception of fatigue,” ‘100 mm’ is the “maximum level of fatigue that may be perceived.” Mean score of VAS fatigue in participants were reported.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of fatigue based on VAS was available for 50 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.||units on a scale||Standard Deviation|Mean
44481|NCT01394276|Secondary|Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab|The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3.ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation.|Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease activity based on 28 joints count was available for 93 participants in TCZ group.||units on a scale||Standard Deviation|Mean
44506|NCT01393899|Secondary|Kaplan-Meier Estimate of the Rate of Time to Relapse|Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8 12, 20 and 26|mFAS, n=number of participants remaining at risk||Percent Probability||80% Confidence Interval|Number
44482|NCT01394276|Primary|Percentage of Participants Achieving Disease Remission After 6 Months of Treatment|Disease remission is defined as a DAS28 score < 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease remission was available for 226 participants in TCZ group.||percentage of participants|||Number
44483|NCT01394276|Primary|Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment|Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant’s judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of low disease activity was available for 226 participants in TCZ group.||percentage of participants|||Number
44484|NCT01394250|Secondary|Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The FLACC score was completed immediately after IV cannulation by a member of the clinical care team who was not part of the study. During initial trial design, the goal was to collect FLACC score pre and post cannulation; however, it was decided prior to enrollment that FLACC score would not be collected pre cannulation, only post.|Up to 5 minutes after IV Cannulation|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.||units on a scale||95% Confidence Interval|Median
44485|NCT01394250|Primary|Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation|The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of “no pain” (0) to “very much pain” (10).|Baseline and 30 minutes|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.||units on a scale||95% Confidence Interval|Mean
44486|NCT01394159|Secondary|Technical Failure|Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved|6 months|||participants|||Number
44487|NCT01394159|Secondary|Diagnosis Achieved With the Needle||6 months|||participants|||Number
44488|NCT01394159|Primary|Compare the Median Number of Passes Required to Establish a Diagnosis||6 months|||No. of passes for diagnosis||Inter-Quartile Range|Median
44489|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN – 3.0; Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 – 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN – 11.5, Gr2:>11.5 – 12.5, Gr3: 12.5 – 13.5, Gr4: >13.5.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
44490|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
44507|NCT01393899|Secondary|Change From Baseline in CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Weeks 4, 8, 12, 20 and 26|mFAS||Score on a scale||Standard Deviation|Mean
44554|NCT01393106|Secondary|Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically||Baseline, Week 8, Week 48, and up to Week 110|ITT Analysis Set||percent change in SPD||Full Range|Median
44491|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes absolute (abs) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils abs: Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
44492|NCT01393964|Secondary|Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.|Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cylcle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants with baseline ADA result and at least one on-treatment ADA result.||participants|||Number
44493|NCT01393964|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.||participants|||Number
44494|NCT01393964|Secondary|Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Vz was measured in mL per kilogram body weight (mL/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
44495|NCT01393964|Secondary|Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. CLT was measured in mL per hour per kilogram body weight (mL/h/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
44496|NCT01393964|Secondary|Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. T-Half was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||h||Standard Deviation|Mean
44706|NCT01391663|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter|Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants||hr||Standard Deviation|Mean
44497|NCT01393964|Secondary|Median Time to Maximal Concentration (Tmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Tmax was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||h||Full Range|Median
44498|NCT01393964|Primary|Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD participants had 2 additional sample times: immediately prior to and immediately after dialysis. AUC was measured in µg*h/mL. PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
44499|NCT01393964|Primary|Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using a validated Enzyme-linked immunoassay (ELISA). Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Cmax was measured in micrograms per milliliter (µg/mL). Pharmacokinetic (PK) parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
44500|NCT01393899|Secondary|Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose|Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.|Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit|Pharmacokinetic analysis set - included all participants who received at least 1 dose of study medication and had at least 1 measurable plasma concentration. n=number of observations above lower limit of quantification.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
44501|NCT01393899|Secondary|Change From Baseline in Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Weeks 8, 12 and 26|mFAS||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
44502|NCT01393899|Secondary|Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline and Weeks 8, 12 and 26|mFAS||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
44503|NCT01393899|Secondary|Change From Baseline in CRP by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 4, 8, 12, 20 and 26|mFAS||milligram per liter (mg/L)||Standard Deviation|Mean
44504|NCT01393899|Secondary|C-Reactive Protein (CRP) by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS||milligram per liter (mg/L)||Standard Deviation|Mean
44505|NCT01393899|Secondary|Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline|Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Week 26|mFAS who were on steroids at A3921084 Baseline||Percentage of participants||80% Confidence Interval|Number
44509|NCT01393899|Secondary|Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
44510|NCT01393899|Secondary|Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
44511|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
44512|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
44513|NCT01393899|Secondary|Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS||Percentage of participants||80% Confidence Interval|Number
44514|NCT01393899|Secondary|Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12 and 20|mFAS||Percentage of participants||80% Confidence Interval|Number
44515|NCT01393899|Primary|Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn’s Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 26|Modified full analysis set (mFAS), defined as all randomized participants who received at least 1 dose of investigational product (ie, active or placebo study medication) in this study and who were randomized into 1 of the tofacitinib (CP-690,550) dose groups in Study A3921083.||Percentage of participants||80% Confidence Interval|Number
44516|NCT01393743|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of Perampanel in Subjects With Inadequately Controlled PGTC Seizures|An Adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the subject was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect (in the child of a subject who was exposed to the study drug). In this study, treatment emergent adverse events (TEAEs) (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first treatment dose till 30 days after the last dose or up to 21 weeks for core study and 142 weeks for extension phase.|The Safety Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had at least 1 postbaseline safety assessment.||Participants|||Number
44517|NCT01393743|Primary|50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance-LOCF (for Core Study)|A responder is a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance-(last observation carried forward (LOCF) from prerandomization. The data is presented as percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set||Percentage of participants|||Number
44519|NCT01393743|Secondary|50% Responder Rate for All Seizure During Maintenance-LOCF (for Core Study)|All seizures includes PGTC, myoclonic, absence and all other seizures that occur during the study. A responder is a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance- LOCF from prerandomization. The data is presented as percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set||Percentage of participants|||Number
44520|NCT01393743|Primary|Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization)- for Core Study|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days (as determined from participant diaries) was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change from baseline in PGTC seizure was analyzed over the Titration and Maintenance Periods combined, while baseline was defined as seizure frequency per 28 days based on all valid diary data during the Prerandomization Phase.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|The Full Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had any postbaseline seizure frequency data during the Randomization Phase.||Percent Change||Full Range|Median
44521|NCT01393743|Secondary|Median Percent Change in Primary Generalized Seizure Subtype Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - for Core Study|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for primary generalized seizure subtype (myoclonic and absence) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set||Percent Change||Full Range|Median
44522|NCT01393743|Secondary|Median Percent Change in All Seizure Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization)- for Core Study|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for all seizures (PGTC, myoclonic, absence and all other seizures that occur during the study) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set||Percent Change||Full Range|Median
44523|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44524|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44525|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44526|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44548|NCT01393106|Secondary|Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire|"Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline.~The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life."|Baseline and up to Week 110|FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint.||units on a scale||Standard Deviation|Mean
44527|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44528|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44529|NCT01393613|Secondary|Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.|Participants discontinued for lack of efficacy during the trial were reported here.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||percentage of participants|||Number
44530|NCT01393613|Secondary|Percentage of Participants With Response at Week 6.|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of 1 or 2.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||percentage of participants|||Number
44531|NCT01393613|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
44532|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44533|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). The analysis of secondary endpoints was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Although only the comparison of brexpiprazole 4 mg/day vs placebo met the gatekeeping threshold in the primary analysis, statistical testing for the other doses was reported for information.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44534|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.|PSP is a validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 3 and Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44535|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.|Severity of illness for each participant was rated using the CGI-S, which was the key secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44536|NCT01393613|Primary|Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.||Units on a scale||Standard Error|Least Squares Mean
44537|NCT01393444|Secondary|Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System|Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.||participants|||Number
44538|NCT01393444|Primary|Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG|Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.||participants|||Number
44539|NCT01393132|Secondary|Tear Film Break up Time|"Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).~The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.~Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms)."|Days 56 (+28 day follow up)|||seconds||Standard Deviation|Mean
44540|NCT01393132|Secondary|Ocular Discomfort Index|"Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).~(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).~The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.~For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time.~OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability."|Days 56 (+28 day follow up)|||units on a scale||Standard Deviation|Mean
44541|NCT01393132|Secondary|Corneal Fluorescein Staining|"Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).~The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability."|Days 56 (+28 day follow up)|||units on a scale||Standard Deviation|Mean
44542|NCT01393132|Primary|Safety|Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).|Day 1, Day 14, Day 28 and Day 56|||event|||Number
44543|NCT01393106|Secondary|Idelalisib Trough and Peak Plasma Concentration at Week 4|Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.|Predose and 1.5 hours postdose at Week 4|Participants in the ITT Analysis Set with available data were analyzed.||ng/mL|||Number
44544|NCT01393106|Secondary|Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug||Up to Week 110|ITT Analysis Set||number of doses||Standard Deviation|Mean
44545|NCT01393106|Secondary|Overall Safety Profile of Idelalisib|"The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. Clinically significant abnormalities in ECG were as determined by the investigator."|Up to Week 110|ITT Analysis Set||percentage of participants|||Number
44546|NCT01393106|Secondary|Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines||Up to Week 110|This analysis was not conducted due to discrepancies with the transfer of samples.|||||
44547|NCT01393106|Secondary|Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age|Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|Baseline and up to Week 110|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
44549|NCT01393106|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.|Up to Week 110|No data are presented because time to treatment failure data were not collected.|||||
44555|NCT01393106|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|Responding Analysis Set: participants who achieved a best response of CR or PR.||months||95% Confidence Interval|Median
44556|NCT01393106|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator.~CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.~PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions."|Up to Week 110|Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
44557|NCT01392742|Secondary|Percentage of Participants With Virological Response|The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.|4 weeks after EOT (up to Week 76)|PP population.||percentage of participants|||Number
44558|NCT01392742|Secondary|Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."||mg||Full Range|Mean
44559|NCT01392742|Secondary|Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."||µg||Full Range|Mean
44560|NCT01392742|Secondary|Duration of Treatment in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."||days||Full Range|Mean
44561|NCT01392742|Secondary|Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response|Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Week 4 and 12|PP population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure||predictive value|||Number
44562|NCT01392742|Secondary|Correlation of SVR With Early Virological Response (EVR)|Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."||correlation coefficient|||Number
44563|NCT01392742|Secondary|Correlation of SVR With Rapid Virological Response (RVR)|Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."||correlation coefficient|||Number
44564|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 12|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 12|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific group."||percentage of participants|||Number
44565|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 4|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 4|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure and n signified evaluable participants for specific group."||percentage of participants|||Number
44566|NCT01392742|Primary|Percentage of Participants Who Were Non-Responders|Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.|Up to 24 weeks after EOT (up to Week 96)|PP population.||percentage of participants|||Number
44567|NCT01392742|Primary|Percentage of Participants With Relapse|Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.|Up to 24 weeks after EOT (up to Week 96)|PP population.||percentage of participants|||Number
44568|NCT01392742|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).|24 weeks after End of treatment (EOT) (up to Week 96)|Per Protocol (PP) population included all participants without any protocol violation.||percentage of participants|||Number
44626|NCT01392326|Secondary|Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis|Week 24|Full Analysis Set||% participants acheiving goal|||Number
44569|NCT01392703|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|Criteria for normal: bilirubin (0.2 to 1.3 mg/dL); lactate dehydrogenase (101 to 227 U/L); eosinophils (0.06 to 0.87*103 c/μL); erythrocytes (4.2 to 5.8*10^6 c/μL). Participants were required to fast for a minimum of 4 hours prior to the collection of specimens for clinical laboratory tests at screening and for at least 8 hours prior to collection on Day -1. Marked abnormalities were reported for the treatment regiment that participants received just prior to clinical laboratory testing.|Day -1, Screening, and Day 9 of current treatment regimen|All participants who received at least 1 dose of any study drug.||Participants|||Number
44570|NCT01392703|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs or Electrocardiogram (ECG) Findings|Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. ECG findings were recorded after the participant had been supine for at least 5 minutes. Clinically significant as reported by principal investigator.|Day -1, Screening, and Days 1, 5, 9 and 10 (at study discharge)|All participants who received at least 1 dose of any study drug.||Participants|||Number
44571|NCT01392703|Secondary|Number of Participants With at Least 1 Adverse Event (AE), With at Least 1 Treatment-related AE, Who Discontinued Due to AEs, and With at Least 1 Serious Adverse Event (SAE)|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant who has received an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is an untoward medical event that at any dose results in death, persistent or significant disability/incapacity; is life-threatening or a congenital anomaly/birth defect; or requires or prolongs hospitalization; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention.|Continually from enrollment through Day 9 and at study discharge on Day 10|All participants who received at least 1 dose of any study drug.||Participants|||Number
44572|NCT01392703|Secondary|Half-life of Dasatinib||Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||Hours||Standard Deviation|Mean
44573|NCT01392703|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib|Single-dose pharmacokinetic parameters, such as Tmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||Hours||Full Range|Median
44574|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib|Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
44575|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib|Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
44576|NCT01392703|Primary|Maximum Observed Concentration (Cmax) of Dasatinib|Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
44577|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure|To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo|Baseline to week 8|Full Analysis Set, participants with non-missing baseline and week 8 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
44578|NCT01392677|Secondary|Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)|To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
44579|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Total Body Weight|To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
44580|NCT01392677|Secondary|Adjusted Mean Change From Baseline in FPG|To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
44581|NCT01392677|Primary|Adjusted Mean Change From Baseline in HbA1c Levels|To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 values||Percent||95% Confidence Interval|Least Squares Mean
44582|NCT01392573|Secondary|Change in Body Weight|Observed mean change from baseline in body weight after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using LOCF.||kg||Standard Deviation|Mean
44583|NCT01392573|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Observed mean change from baseline in HbA1c after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
44625|NCT01392326|Secondary|Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis|Week 24|Full Analysis Set||% of participants acheiving goal|||Number
44584|NCT01392560|Primary|Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia|The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia|Baseline and 8 weeks|Per protocol set for renal (PPS_RENAL) consists of all patients who were treated with study drug and had a baseline measurement and evaluable post-dosing renal data under the clamped hyperglycemia condition for the primary endpoint.||mL/min/1.73 m^2||Standard Error|Mean
44585|NCT01392547|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies|Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.||Subjects|||Number
44586|NCT01392547|Secondary|Number of Adverse Events|Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.||events|||Number
44587|NCT01392547|Secondary|Number of Doses of Trial Product Given for Each Acute Bleed||Up to 6 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.||bleeding episodes|||Number
44588|NCT01392547|Secondary|Effective and Sustained Bleeding Control||Up to 48 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.||bleeding episodes|||Number
44589|NCT01392547|Primary|Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given||Within 12 hours of first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.||bleeding episodes|||Number
44590|NCT01392495|Secondary|Medical Resource Utilization||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.|||||
44591|NCT01392495|Secondary|Time to Clinical Worsening (TTCW) Endpoints||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.|||||
44592|NCT01392495|Secondary|Change From Baseline in the Six Minute Walk Distance (6MWD)||baseline, 144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.|||||
44593|NCT01392495|Primary|Number of Patients With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the trial.|144 weeks|Safety Analysis Set: The safety analysis set included all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment.||Participants|||Number
44594|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Toddler dose up to 1 Month (28 to 42 days) after toddler dose|Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.||participants|||Number
44595|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).|1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose|Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.||participants|||Number
44602|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.||percentage of participants||95% Confidence Interval|Number
44596|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Baseline up to 1 Month (28 to 42 days) after infant series|Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.||participants|||Number
44597|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after toddler dose|Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’ =participants reporting yes for >=1 day or no for all days for specified event for each arm, respectively.||percentage of participants|||Number
44598|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.|Within 4 days after infant series Dose 3|Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.||percentage of participants|||Number
44599|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 2|Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.||percentage of participants|||Number
44600|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1|Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 1|Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. ‘N’(number of participants analyzed)=participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.||percentage of participants|||Number
44601|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.||percentage of participants||95% Confidence Interval|Number
44603|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||titer||95% Confidence Interval|Geometric Mean
44604|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mIU/mL||95% Confidence Interval|Geometric Mean
44605|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||IU/mL||95% Confidence Interval|Geometric Mean
44606|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||EU/mL||95% Confidence Interval|Geometric Mean
44607|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mcg/mL||95% Confidence Interval|Geometric Mean
44608|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||titer||95% Confidence Interval|Geometric Mean
44609|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mIU/mL||95% Confidence Interval|Geometric Mean
44610|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||IU/mL||95% Confidence Interval|Geometric Mean
44611|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||EU/mL||95% Confidence Interval|Geometric Mean
44612|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.||mcg/mL||95% Confidence Interval|Geometric Mean
44613|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series|Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
44614|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series|Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.||percentage of participants||95% Confidence Interval|Number
44703|NCT01391858|Primary|Oral Opioids Consumption|Oral opioids consumption after mastectomy until hospital discharge.|Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy|||milligram (mg)||Inter-Quartile Range|Median
44615|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.|1 month after the toddler dose|mITT toddler immunogenicity set: eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
44616|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
44617|NCT01392378|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
44618|NCT01392326|Secondary|Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline||Week 24|Full Analysis set||% participants|||Number
44619|NCT01392326|Secondary|Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline||Week 24|Full analysis set||% participants|||Number
44620|NCT01392326|Secondary|Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)|Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.|Week 24|.Full analysis set.||units on a scale||Standard Error|Mean
44621|NCT01392326|Secondary|Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.|Week 24|Full analysis set||% participant|||Number
44622|NCT01392326|Secondary|Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg|"HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities – dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week Are you able to … perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled)."|Week 24|Full Analysis Set||units on a scale||Standard Error|Least Squares Mean
44623|NCT01392326|Secondary|Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Week 24|Full Analysis Set||units on scale||Standard Error|Least Squares Mean
44624|NCT01392326|Secondary|Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg|"DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 (0:no activity, 100: highest activity possible)"|Week 24|Full Analysis Set||units on scale||Standard Error|Least Squares Mean
51747|NCT01300286|Secondary|Fresh Frozen Plasma Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||mL||Inter-Quartile Range|Median
44627|NCT01392326|Primary|Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)|Week 24|Full analysis set||% participant|||Number
44628|NCT01391559|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication|FEV1|2 hours|||mL||Standard Deviation|Mean
44629|NCT01391507|Secondary|Number of Participants With Holter Electrocardiography (ECG) Parameters|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.||Participants|||Number
44630|NCT01391507|Secondary|Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.||Beats per minute||Standard Deviation|Mean
44631|NCT01391507|Secondary|Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6|Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant’s perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Units on a scale||Standard Deviation|Mean
44632|NCT01391507|Secondary|Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression|Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants).|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Participants|||Number
44633|NCT01391507|Secondary|Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6|A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.||Meter||Standard Deviation|Mean
44634|NCT01391507|Secondary|Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6|Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||Centimeter (cm)/ Second (sec)||Standard Deviation|Mean
44635|NCT01391507|Secondary|Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6|Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. No participants were evaluable for arms COR-1 80 mg and COR-1 160 mg.||Centimeter (cm)||Standard Deviation|Mean
44636|NCT01391507|Secondary|Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6|The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.||Picogram (pg)/ Milliliter (mL)||Standard Deviation|Mean
44637|NCT01391507|Secondary|Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9|The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).|Baseline and Month 9|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.||Percentage of blood pumped out||Standard Deviation|Mean
44638|NCT01391507|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6|The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).|Baseline and Month 6|Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment. Missing data was imputed using last observation carried forward (LOCF) method.||Percentage of blood pumped out||Standard Deviation|Mean
44704|NCT01391858|Primary|The Postoperative Opioid Requirement After Mastectomy|IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy|Participants received PCA pump, an average of 24 hrs after mastectomy|||milligram (mg)||Inter-Quartile Range|Median
44639|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44640|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44641|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44642|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44643|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44644|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44645|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44646|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44647|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44648|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44649|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44650|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44651|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44652|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44653|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44654|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44655|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44656|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44657|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44685|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44658|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44659|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44660|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44661|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44662|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44663|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44664|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44665|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44666|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44698|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 30th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
44699|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 14th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
44667|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44668|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44669|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44670|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44671|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44672|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44673|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44674|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44675|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44700|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 7th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
44676|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44677|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44678|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44679|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44680|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44681|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44682|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44683|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44684|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44701|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at hospital discharge, an average of 3 days after mastectomy|||units on a scale||Inter-Quartile Range|Median
44686|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).||participants|||Number
44687|NCT01392300|Primary|Investigator's Global Impression of Change|This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case).||units on a scale||Standard Error|Least Squares Mean
44688|NCT01392300|Primary|Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern|"Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow.~The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.||units on a scale||Standard Error|Least Squares Mean
44689|NCT01392170|Primary|Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)|Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).|12 months from start of treatment with PEG-IFNá-2a|Study terminated due to low accrual. No participants were evaluable for outcome.|||||
44690|NCT01392053|Secondary|Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.|Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers. Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups. The questionnaire applied after labour intended to assess how most women felt regarding this subject.|30 minutes|All patients participatin in the study answered a satisfaction questionnaire after labour.||participants|||Number
44691|NCT01392053|Secondary|Obstetric Outcomes - Moment of Utilization of Oxytocin|Oxytocin is a drug used to induce or enhance the muscular activity of the uterus. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed||centimeters||Standard Deviation|Mean
44692|NCT01392053|Secondary|Obstetric Outcome - Moment of Corioamniorrhexis|Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed||centimeters||Standard Deviation|Mean
44693|NCT01392053|Secondary|Obstetric Outcomes - Duration of Labour|"The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design. It was defined two sets of measures dichotomizing the groups into up to 7 hours or more than 7 hours."|10 hours|All patients in both groups were analyzed||percentage of participants|||Number
44694|NCT01392053|Secondary|Obstetric Outcomes - Delivery|Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress.|10 hours|All patients of both groups were analyzed.||participants|||Number
44695|NCT01392053|Secondary|Pharmacological Analgesia Request According to the Cervical Dilation.|In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly. Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods.|10 hours|Of the 46 patients who where evaluated, only 1 (one) in each group didn't request pharmacological analgesia and, thus, were excluded of the analysis of this specific outcome||centimeters||Standard Deviation|Mean
44696|NCT01392053|Primary|Effectiveness of Massage Therapy in Pain Relief During Labor.|The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.|30 minutes|A pilot study was conducted previously to determine the size of the population needed. Using a paired sample t-test, with a power of 95% and 5% significance level, it was determined a minimum of 12 patients for Control Group and 16 patients for Massage Group||milimeters||Standard Deviation|Mean
44697|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 90th day after mastectomy|||units on a scale||Inter-Quartile Range|Median
44707|NCT01391663|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.|Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.|Day 1-4, Day 10.|Healthy Korean Participants||ng·hr/mL||Standard Deviation|Mean
44708|NCT01391663|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter|Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants||ng·hr/mL||Standard Deviation|Mean
44709|NCT01391663|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10.|Healthy Korean Participants||hr||Full Range|Median
44710|NCT01391663|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter|Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10|Healthy Korean Participants||ng/mL||Standard Deviation|Mean
44711|NCT01391468|Post-Hoc|Change of Serum IL-10 Level at 6 Months|IL-10 is an anti-inflammatory cytokine; The change of serum IL-10 level at 6 months was measured|6 months|||pg/ml||Standard Deviation|Mean
44712|NCT01391468|Post-Hoc|Change of Serum Endotoxin Level at 6 Months|endotoxin is a marker of inflammation in chronic kidney disease patients|6 months follow-up|||EU/ml||Standard Deviation|Mean
44713|NCT01391468|Secondary|Change of Gastrointestinal Symptoms at 6 Months|The change in gastrointestinal symptom rating scale (min and maximum scores 0-45) after treatment. The total score is reported. The higher scale represents a worse outcome.|6 months follow-up|||units on a scale||Standard Deviation|Mean
44714|NCT01391468|Primary|the Occurrence of Cardiovascular Event and Peritonitis Events||6 month follow-up|||participants|||Number
44715|NCT01391325|Secondary|Mean Change From Baseline to Month 6 in SF-36 PCS+MCS|The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.|Month 6|Subjects who recieved at least one dose of allopurinol||units on a scale||Standard Deviation|Mean
44716|NCT01391325|Secondary|Incidence of Gout Flares|Proportion of subjects who experienced at least one gout flare requiring treatment during the study.|Every month for 6 months.|Subjects who received at least one dose of allopurinol||percentage of subjects||95% Confidence Interval|Number
44717|NCT01391325|Secondary|Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL|Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.|Month 6|All subjects who received at least one dose of allopurinol||percentage of subjects||95% Confidence Interval|Number
44718|NCT01391325|Primary|Safety of Allopurinol|Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.|Every month for 6 months.|All subjects who received at least one dose of allopurinol||percentage of subjects|||Number
44719|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60|The Investigator rated the subject’s severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 60|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.||Percentage of participants|||Number
44720|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30|The Investigator rated the subject’s severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.||Percentage of participants|||Number
44721|NCT01391312|Primary|Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30|Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.||Percentage of participants|||Number
44722|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest|Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.||Percentage of participants|||Number
44723|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest|The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.||Percentage of participants|||Number
44762|NCT01390844|Secondary|Percentage of Participants in India Achieving EVR at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
44724|NCT01391299|Secondary|Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines|Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.|Day 30|Includes participants from the Intent-to-treat Population (all randomized participants) with a rating of very unsatisfied, unsatisfied or neutral in the Subject's Assessment of Satisfaction of Appearance at baseline.||Percentage of participants|||Number
44725|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
44726|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
44727|NCT01391286|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||Units on a scale||Full Range|Median
44728|NCT01391286|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||mm^2||Full Range|Median
44729|NCT01391286|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||mm||Full Range|Median
44730|NCT01391286|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.||Percentage of participants|||Number
44731|NCT01391273|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||Units on a scale||Standard Deviation|Mean
44732|NCT01391273|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.||mm^2||Standard Deviation|Mean
44733|NCT01391273|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent to treat population included all randomized participants.||mm||Standard Deviation|Mean
44734|NCT01391273|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.||Percentage of participants|||Number
44735|NCT01391013|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||CD4 cells||Inter-Quartile Range|Median
44736|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of ‘0’ and a standard deviation of ‘1’. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Z score||Inter-Quartile Range|Median
44737|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||T score||Inter-Quartile Range|Median
44738|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of ‘0’ and a standard deviation of ‘1’. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Z score||Inter-Quartile Range|Median
44739|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||T score||Inter-Quartile Range|Median
44740|NCT01391013|Secondary|Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)|Visceral fat content in abdomen will be analyzed with median change in VAT by an abdomen Computerized Tomography.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||cm square||Inter-Quartile Range|Median
44741|NCT01391013|Secondary|Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)|Leg fat content will be analyzed by Dual Energy X-ray Absortiometry (DEXA scan).|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Percentage of fat||Inter-Quartile Range|Median
44742|NCT01391013|Secondary|Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score|The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of a participant. It is calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, and systolic blood pressure. The framingham risk score is calculated as: for males: 0 point (1 percentage) up to 17 points (30 percentages); whereas for females: 0 to 9 points (1 percentage) up to 25 points (30 percentage). Higher scores indicate high cardiovascular risk.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Framingham risk score||Inter-Quartile Range|Median
44743|NCT01391013|Secondary|Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The Homeostatic Model Assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. HOMA-IR is reflected in the diminished effect of insulin on hepatic glucose production. HOMA-IR is calculated as: (Glucose [mg/dL] X Insulin [pmol/L]) / (405 X 6.945). Higher scores indicate worse insulin resistance.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||HOMA score||Inter-Quartile Range|Median
44744|NCT01391013|Secondary|Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||mg/dL||Inter-Quartile Range|Median
44745|NCT01391013|Secondary|Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||mg/dL||Inter-Quartile Range|Median
44746|NCT01391013|Secondary|Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL||Baseline (Day1 of Week 1), Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||mg/dL||Inter-Quartile Range|Median
44747|NCT01391013|Secondary|Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Endothelial cells||Full Range|Median
44748|NCT01391013|Secondary|Change From Baseline to Week 48 in Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Endothelial cells||Full Range|Median
44749|NCT01391013|Secondary|Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Participants|||Number
44750|NCT01391013|Secondary|Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Percentage of brachial artery diameter||Inter-Quartile Range|Median
44751|NCT01391013|Primary|Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline (Day 1 of Week 1) to Week 24|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.||Percentage of brachial artery diameter||Inter-Quartile Range|Median
51748|NCT01300286|Secondary|Packed Red Blood Cell Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)|||units||Inter-Quartile Range|Median
44752|NCT01390909|Primary|Average Annualized Costs|Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.|1 year|For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.||United States dollars||Standard Deviation|Mean
44753|NCT01390870|Primary|Number of Participants Reporting Compliance With Medication|"Compliance was calculated based on the participant's response to the following question: In general, how many times did you miss taking your prostate medication? Responses were measured on a 5-point scale. Participants who answered I never miss a dose of my medication were considered compliant. All other responses were considered non-compliant."|Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)|All enrolled participants taking 5-alpha reductase inhibitors and/or alpha blockers||participants|||Number
44754|NCT01390857|Secondary|Number of Participants Classified as Effective and Not Effective|"The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. “Improved” was regarded as “Effective,” and “Unchanged” and ” Worsen” were regarded as “Not effective. The two participants classifed as “Not effective” were classified as “Unchanged.”"|1 month|Efficacy Analysis Set: all participants assessed for efficacy who completed all study visits; 7 participants did not undergo an efficacy evaluation, and 13 participants failed to visit after the first visit.||participants|||Number
44755|NCT01390857|Secondary|Number of Participants With Any Unexpected Adverse Drug Reactions|An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.|1 month|ITT Safety Population||participants|||Number
44756|NCT01390857|Secondary|Number of Participants With the Indicated Adverse Drug Reactions|"An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|1 month|ITT Safety Population||participants|||Number
44757|NCT01390857|Primary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|1 month|Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants.||participants|||Number
44758|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in India|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
44759|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in Korea and Taiwan|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.||Percentage of Participants|||Number
44760|NCT01390844|Secondary|Percentage of Participants With an AE of Anemia in India|Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
44761|NCT01390844|Secondary|Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan|Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|All Participants as Treated (APaT) - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.||Percentage of Participants|||Number
44763|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).||Percentage of Participants|||Number
44764|NCT01390844|Secondary|Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm); participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
44765|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm).||Percentage of Participants|||Number
44766|NCT01390844|Primary|Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.||Percentage of Participants|||Number
44767|NCT01390844|Primary|Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population|SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).||Percentage of Participants|||Number
44768|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.|in selected 30-second SENSIMED Triggerfish recording intervals during sleep|One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.||% of accurate recording intervals||95% Confidence Interval|Number
44769|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|"Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep.~One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording."|from 1 hour before sleep to 1 hour after sleep|Subjects were included in this analysis if the difference in IOP from wake to sleep was at least 3 mmHg, as determined using pneumatonometry on the eye contralateral to that of SENSIMED Triggerfish, and if the SENSIMED Triggerfish recording contained at least 80% of the expected data points.||mV/h||Standard Deviation|Mean
44770|NCT01390649|Secondary|Responder Rate|The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to ≥ 50 x 10^9/L after the first IgPro10 administration).|Within 6 days after the first infusion|Full analysis set: all subjects who received at least 1 IgPro10 infusion.||percentage of participants||95% Confidence Interval|Number
44771|NCT01390649|Primary|Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis|The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.|Within 3 days of infusion||||||
44772|NCT01390441|Primary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation in the Extension Study|Serum ADA positivity is determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 56, Week 68, Week 80, Week 82, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.|||||
44773|NCT01390441|Primary|Number of Participants With Immunoglobulin G (IgG) Response in the Extension Study|Serum IgG levels are determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 68, Week 80, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.|||||
44774|NCT01390441|Other Pre-specified|Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point|The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP.|Baseline, Week 6, Week 12|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.||Score||Standard Deviation|Mean
44775|NCT01390441|Other Pre-specified|Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.||Participants|||Number
44776|NCT01390441|Other Pre-specified|Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|Full Analysis Set defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.||Participants|||Number
44777|NCT01390441|Secondary|Part B: Cmax After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment.|Day 15|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.|||||
44778|NCT01390441|Secondary|Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3.|Day 15|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15); had no major protocol violations; had a complete PK profile; had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course.||ng/mL||95% Confidence Interval|Geometric Mean
44779|NCT01390441|Primary|Number of Participants Who Discontinued Study Drug Due to Adverse Events|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks|APaT population defined as all participants who received at least one dose of study drug.||Participants|||Number
44780|NCT01390441|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks|All Participants as Treated (APaT) population defined as all participants who received at least one dose of study drug.||Participants|||Number
44781|NCT01390441|Primary|Part B: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.|||||
44820|NCT01389882|Secondary|Expiratory Tidal Volume|Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mL/Kg||Standard Deviation|Mean
44782|NCT01390441|Primary|Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15), had no major protocol violations, had a complete pharmacokinetic (PK) profile, had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course||hr*mg/mL||95% Confidence Interval|Geometric Mean
44783|NCT01390428|Primary|Apparent Terminal Half-life (t1/2) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||hr.||Geometric Coefficient of Variation|Geometric Mean
44784|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10|Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 10 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||nM||95% Confidence Interval|Geometric Mean
44785|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Mild HI, Moderate HI and Healthy Matched to Mild HI or Moderate HI are absent because they had a different Measure Type and Method of Dispersion||nM||Full Range|Median
44786|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Severe HI and Matched Healthy to Severe HI are absent because they had a different Measure Type and Method of Dispersion||nM||95% Confidence Interval|Geometric Mean
44787|NCT01390428|Primary|Time to Peak Concentration (Tmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||hr.||Full Range|Median
44788|NCT01390428|Primary|Maximum Concentration (Cmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||uM||95% Confidence Interval|Geometric Mean
44789|NCT01390428|Primary|Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||95% Confidence Interval|Geometric Mean
44790|NCT01390415|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 6.|Baseline and Month 6|||mmHg||Standard Deviation|Mean
44791|NCT01390415|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 6.|Baseline and Month 6|||mmHg||Standard Deviation|Mean
44792|NCT01390415|Primary|Number of Participants With Macroalbuminuria After 6 Months of Treatment|Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.|Baseline and Month 6|||participants|||Number
44793|NCT01390402|Primary|Number of Participants With Molecular Complete Remission at 3 Month Post Transplant|Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.|Baseline to up to 4 months post-transplant|||participants|||Number
44794|NCT01390389|Secondary|To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.|Changes in PCr and beta NTP will be demonstrated in Geri BD group challenged with CoQ10.|4-week trial||||||
44821|NCT01389882|Secondary|Minute Ventilation|Minute ventilation measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||L/min/Kg||Standard Deviation|Mean
44795|NCT01390389|Primary|Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline|Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.|Baseline|||Integration Expressed as Arbitrary Unit||Standard Error|Mean
44796|NCT01390259|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|22 hours|||mg/dL||Standard Error|Mean
44797|NCT01390259|Secondary|Percent Time in Euglycemia|Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl|22 hours|||percentage of time in range||Standard Error|Mean
44798|NCT01390259|Primary|Hypoglycemic Events|"Number of hypoglycemic events below 70 mg/dL per patient per day~Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms"|22 hours|||events/patient||Standard Error|Mean
44799|NCT01390233|Primary|Vaginal Delivery|The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.|Gestational age 26-42 weeks|||participants|||Number
44800|NCT01390038|Secondary|Pain: Visual Analog Scale|0 (best) - 10 (worst)|24 Months|||units on a scale||Standard Deviation|Mean
44801|NCT01390038|Secondary|American Shoulder and Elbow Surgeon Score|0 (worst) - 100 (best)|24 Months|||units on a scale||Standard Deviation|Mean
44802|NCT01390038|Secondary|Device Parameters|"Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:~Migration~Osteolysis~Subsidence"|24 months|||Percentage of participants|||Number
44803|NCT01390038|Secondary|Strength|Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier|24 months|||Pounds||Standard Deviation|Mean
44804|NCT01390038|Secondary|Range of Motion|"Elevation in the scapula plane~Internal rotation with arm at the side~External rotation with arm at the side"|24 months|||Degrees||Standard Deviation|Mean
44805|NCT01390038|Secondary|Quality of Life|"Simple Shoulder Test~1 (worse) - 12 (best)"|24 months|||units on a scale||Standard Deviation|Mean
44806|NCT01390038|Primary|Device Success Rate|"A subject is a Patient Success at 24-months if:~There is NO continuous radiolucent line around the prosthesis; and~The adjusted Constant Score is > 85 (successful outcome); and~They did not have revision surgery; and~They did not have a system-related serious adverse event."|24 months|||participants|||Number
44807|NCT01389973|Secondary|Part 1: Percent Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, and Bilirubin Concentration at Week 28||Baseline and Week 28|"Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial). N (number of participants analyzed) signifies participants who were evalubale for this outcome measure. n signifies participants who were evalubale for each specified category."||percent change||Standard Deviation|Mean
44808|NCT01389973|Secondary|Part 1: Percent Change From Baseline in ALP Concentration at Week 28||Baseline and Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||percent change||Standard Deviation|Mean
44809|NCT01389973|Secondary|Part 1: Number of Participants With ALP Remission at Week 28|ALP remission is defined as either normalization of ALP (for participants with baseline ALP between 1.67*and 2.8* upper limit of normal [ULN] or an ALP less than [˂]1.67*ULN [for participants with baseline ALP greater than {˃} 2.8* ULN]). ALP levels above 1.67* ULN level were associated with an increased rate of disease progression.|Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||participants|||Number
44810|NCT01389973|Secondary|Part 1: Number of Participants With ALP Response at Week 28||Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||participants|||Number
44811|NCT01389973|Primary|Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12|The ALP response was defined as a greater than 40 percent (%) decrease from Baseline in ALP concentration at Week 12.|Week 12|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).||participants|||Number
44812|NCT01389882|Secondary|Capillary Blood HCO3|Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mmol/L||Standard Deviation|Mean
44813|NCT01389882|Secondary|Capillary Blood pO2|Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mmHg||Standard Deviation|Mean
44814|NCT01389882|Secondary|Capillary Blood pCO2|Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mmHg||Standard Deviation|Mean
44815|NCT01389882|Secondary|Capillary Blood pH|Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||pH||Standard Deviation|Mean
44816|NCT01389882|Secondary|Fraction of Oxygen|Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode|four hours|||percentage of concentration||Full Range|Median
44817|NCT01389882|Secondary|Peak EAdi|Peak electrical activity of the diaphragm|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||uV||Standard Deviation|Mean
44818|NCT01389882|Secondary|Work of Breathing|Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mJ/L||Full Range|Median
44819|NCT01389882|Secondary|Dynamic Compliance|Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||mL/cmH2O||Standard Deviation|Mean
44822|NCT01389882|Secondary|Mean Airway Pressure|mean airway pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||cmH2O||Standard Deviation|Mean
44823|NCT01389882|Primary|Peak Inspiratory Pressure|peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."||cmH2O||Standard Deviation|Mean
44824|NCT01389856|Secondary|Accumulation Index (AI) for Bosentan|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Days 1 and 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AI was calculated as the ratio AUCtau /AUC0-12 for the subjects having PK samples collected on Day 1 and Day 5 and with AUC0-12 > 0 ng.h/mL.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||accumulation index||95% Confidence Interval|Geometric Mean
44825|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 5 (AUC0-24C Day 5) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 5 was calculated as a multiple of AUCtau, (2 × AUCtau for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
44826|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 1 (AUC0-24C Day 1) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 1 was calculated as a multiple of AUC0-12, (2 × AUC0-12 for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
44827|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Dosing Interval at Steady State on Day 5 (AUCtau) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUCtau Day 5 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
44828|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 12 h (AUC0-12 Day 1)) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-12 Day 1 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||h*ng/mL||95% Confidence Interval|Geometric Mean
44829|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
44830|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
45494|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|1 month|||Log10 copies per ml||Standard Deviation|Mean
44831|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
44832|NCT01389856|Secondary|Tmax for Bosentan on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
44833|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
44834|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
44835|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
44836|NCT01389856|Secondary|Time to Maximum Whole Blood Concentration (Tmax) for Bosentan on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||hours||Full Range|Median
44837|NCT01389856|Secondary|Cmax for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Cmax obtained directly from the measured concentrations . Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||ng/mL||95% Confidence Interval|Geometric Mean
44838|NCT01389856|Secondary|Maximum Whole Blood Concentration (Cmax) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Cmax was obtained directly from the measured concentrations. Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|up to 12 hours|Pharmacokinetic (PK) analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.||ng/mL||95% Confidence Interval|Geometric Mean
44839|NCT01389856|Secondary|Change in Fraction of Inspired Oxygen (FiO2) From Baseline to 72 Hours Following Study Drug Administration|FiO2 was determined according to each study centers’ standard procedure at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage of oxygen||95% Confidence Interval|Median
44840|NCT01389856|Secondary|Change in Post-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage saturation||95% Confidence Interval|Median
44841|NCT01389856|Secondary|Change in Pre-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage saturation||95% Confidence Interval|Median
45611|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|3 months|All study subjects||participants|||Number
44842|NCT01389856|Secondary|Change in Partial Pressure of Carbon Dioxide (PaCO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaCO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||mm Hg||95% Confidence Interval|Median
44843|NCT01389856|Secondary|Change in Partial Pressure of Oxygen (PaO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||mm Hg||95% Confidence Interval|Median
44844|NCT01389856|Secondary|Change in Arterial Blood Oxygen Saturation (SaO2) From Baseline to 72 Hours Following Study Drug Administration|SaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||percentage saturation||95% Confidence Interval|Median
44845|NCT01389856|Secondary|Change in Arterial Blood Gas (ABG) pH From Baseline to 72 Hours Following Study Drug Administration|pH was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data||pH||95% Confidence Interval|Median
44846|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 72 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|72 hours|Randomized and treated patients with available data||oxygenation index||95% Confidence Interval|Median
44847|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 48 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|48 hours|Randomized and treated patients with available data||oxygenation index||95% Confidence Interval|Median
44848|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 24 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|24 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
44849|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 12 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|12 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
44850|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 5 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|5 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
44851|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 3 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|3 hours|Randomized and treated patients||oxygenation index||95% Confidence Interval|Median
44852|NCT01389856|Secondary|Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment|"The presence of PH was assessed by echocardiography. PH was reported as ‘present’ if at least one of the following criteria was met:~Shunt through ductus arteriosus was either ‘predominant right to left’ or ‘bidirectional’~Shunt through foramen ovale was either ‘predominant right to left’ or ‘bidirectional’~Marked right ventricular dilation was ticked ‘present’~Paradoxical shift of intraventricular septum was ticked ‘present’~Right ventricular systolic pressure (mmHg) was > 2/3 of the reported systemic blood pressure"|From baseline to up to 14 days|Randomized and treated patients||percentage of participants|||Number
44853|NCT01389856|Secondary|Percentage of Patients Requiring Re-initiation of iNO Therapy|Re-initiation of iNO therapy following weaning from iNO therapy|From baseline to up to 21 days|Randomized and treated patients||percentage of participants|||Number
44854|NCT01389856|Primary|Time to Complete Weaning From Mechanical Ventilation|Calculated from the time from first study drug administration to complete weaning from mechanical ventilation|From baseline to up to 21 days|Randomized and treated patients||days||95% Confidence Interval|Median
44855|NCT01389856|Primary|Time to Complete Weaning From iNO|Calculated from the time from first study drug administration to complete weaning from iNO. Weaning from iNO was considered complete if there was no requirement for the re-initiation of iNO within 24 h after stopping|From baseline to up to 21 days|Randomized and treated patients||days||95% Confidence Interval|Median
44856|NCT01389856|Primary|Percentage of Patients With Treatment Failure|Treatment failure was defined as the need for extra corporeal membrane oxygenation or initiation of alternative pulmonary vasodilator treatment|From baseline to up to 21 days|Randomized and treated patients||percentage of participants|||Number
44857|NCT01389817|Primary|N95 Peak Via pERG and fERG -PhNR|The primary comparison will be a paired comparison of pre- and post-treatment retinal ganglion cell N95 pattern electroretinogram (pERG) peaks and fERG - Photopic Negative Response (PhNR). Pairing will be done between a subject's treatment and control eye.|12 months|All participants were withdrawn before any data could be obtained.|||||
44870|NCT01389284|Secondary|Summed, Time-weighted Pain Intensity Differences (SPID)|Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose|Intent-to-treat (ITT)||Score on the scale||95% Confidence Interval|Mean
44858|NCT01389323|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died|An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.|From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])|"All treated participants for TP and all follow-up participants for FUP. Here, n signifies the number of participants evaluable in their respective study periods."||participants|||Number
44859|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.||percentage of participants||95% Confidence Interval|Number
44860|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels <LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.||percentage of participants||95% Confidence Interval|Number
44861|NCT01389323|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category.||percentage of participants||95% Confidence Interval|Number
44862|NCT01389323|Primary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts.||percentage of participants||95% Confidence Interval|Number
44863|NCT01389284|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent|24 hours postdose or immediately before the first intake of rescue medication|Intent-to-treat (ITT)||Participants|||Number
44864|NCT01389284|Secondary|Number of Times the Participants Took Rescue Medication Over the 24-hour Period||24 hours postdose|Intent-to-treat (ITT)||Rescue medication intakes||Standard Deviation|Mean
44865|NCT01389284|Secondary|Cumulative Percentage of Participants Who Took Rescue Medication||At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)||Percentage of participants|||Number
44866|NCT01389284|Secondary|Median Time to First Intake of Rescue Medication|Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group.|Up to 24 hours postdose|Intent-to-treat (ITT)||Hours||Full Range|Median
44867|NCT01389284|Secondary|Pain Relief From Initial Dose|Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief|At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)||Score on the scale||Standard Deviation|Mean
44868|NCT01389284|Secondary|Pain Intensity Differences (PIDs) by Time From Initial Dose|Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe|At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)||Score on the scale||95% Confidence Interval|Mean
44869|NCT01389284|Secondary|Summed, Time-weighted Total Pain Relief Scores (TOTPARs)|TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24.|0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose|Intent-to-treat (ITT)||Score on the scale||95% Confidence Interval|Mean
44871|NCT01389284|Primary|Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)|SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|From 0 to 24 hours post-dose|Intent-to-treat (ITT)||Score on the scale||Standard Error|Mean
44872|NCT01389102|Primary|Mean Change the Severity of Moderate to Severe Vasomotor Symptoms|"Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.~Mild, moderate and severe were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3."|baseline to week 12 (12 weeks)|||Scores on a scale||Standard Deviation|Mean
44873|NCT01389102|Primary|Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day|"Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day.~Mild, moderate and severe hot flushes and sweating were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity"|baseline to week 12|||Vasomotor symptoms per day||Standard Deviation|Mean
44874|NCT01389076|Secondary|Number of Participants That Experienced SAEs During Treatment.||Up to week 13|||participants|||Number
44875|NCT01389076|Secondary|Median Progression Free Survival (PFS) Time|The median time patients survived without progression.|2 Years|Due to the withdrawal of Bexxar by the manufacture and failure to find another supplier, the trial was abandoned and follow-up scans were not obtained. Therefore only survival is known. Progression information is not available.|||||
44876|NCT01389076|Secondary|The Percentage of Participants Alive at 2 Years|Overall survival was examined at 2 years|2 years|||percentage of participants|||Number
44877|NCT01389076|Secondary|Percentage of Participants That Respond to Treatment|"The overall response rate (PR [partial response] + CR [complete response]) was determined.~Partial response is defined as the regression of measurable disease with no new sites of disease.~Complete response is defined as the disappearance of all evidence of disease."|2 years|||percentage of participants||95% Confidence Interval|Number
44878|NCT01389076|Primary|Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment|The percentage of patients that experience early onset HAMA conversion following treatment. Early-onset HAMA is defined as antimouse antibody levels (in blood serum) of at least 5 times the level of detection, occurring at or prior to the 7th week of I-131 tositumomab therapy.|7 weeks|||percentage of participants||95% Confidence Interval|Number
44879|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively|three months|Below the number of patients with pain three months postoperatively. For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.||Number of participants|||Number
44880|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively|one month postoperatively|Below the number of patients with pain one month postoperatively For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.||number of participants|||Number
44881|NCT01388946|Secondary|Pain Scores During Cough 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient in this group presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 48 h postoperatively||mm||Standard Deviation|Mean
44882|NCT01388946|Secondary|Pain Scores During Cough 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) 8 h postoperatively||mm||Standard Deviation|Mean
44883|NCT01388946|Secondary|Pain Scores During Cough 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 4 h postoperatively||mm||Standard Deviation|Mean
44884|NCT01388946|Secondary|Pain Scores During Cough 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 2 h postoperatively||mm||Standard Deviation|Mean
44885|NCT01388946|Secondary|Pain Scores During Cough in the PACU|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|PACU|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough in PACU||mm||Standard Deviation|Mean
44905|NCT01388816|Secondary|Changes in CETP Inhibition in Plasma|Percent change from baseline in CETP Inhibition|28 days|ITT with LOCF||percentage from baseline||95% Confidence Interval|Least Squares Mean
44906|NCT01388816|Secondary|To Evaluate Trough Levels of DRL-17822 in Plasma|Trough levels of DRL-17822 in plasma after 28 days of treatment|28 days|||ng/mL||Standard Deviation|Mean
44886|NCT01388946|Secondary|Pain Scores at Rest 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|50 patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. 1 patient in this group presented ileus after the first 24 h assessment, remaining 49 patients for assessment at 48 hours postoperatively Below are the VAS values (mean and standard deviation) at rest 48 hours postoperatively||mm||Standard Deviation|Mean
44887|NCT01388946|Secondary|Pain Scores at Rest 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 24 h postoperatively||mm||Standard Deviation|Mean
44888|NCT01388946|Secondary|Pain Scores at Rest 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 8 h postoperatively||mm||Standard Deviation|Mean
44889|NCT01388946|Secondary|Pain Scores at Rest 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 4 h postoperatively||mm||Standard Deviation|Mean
44890|NCT01388946|Secondary|Pain Scores at Rest 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h postoperatively|"Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery.~Below are the VAS values (mean and standard deviation) 2 h postoperatively at rest"||mm||Standard Deviation|Mean
44891|NCT01388946|Secondary|Pain Scores in the Postoperative Care Unit (PACU) at Rest|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|in PACU|Below is the mean and standard deviation of the VAS scores in PACU at rest Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery||mm||Standard Deviation|Mean
44892|NCT01388946|Primary|VAS Score Changes ( Cough) During 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24 h|Fifty patients in the Ropivacaine group were analyzed for the primary (VAS score at cough) and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery||mm||Standard Deviation|Mean
44893|NCT01388920|Secondary|Plasma Glucose|Changes from baseline in fasting blood glucose|6 months||||||
44894|NCT01388920|Secondary|COPD Exacerbations|Frequency and severity of COPD exacerbations|6 months||||||
44895|NCT01388920|Secondary|Adverse Events|Number and percentage of subjects with adverse events|6 months||||||
44896|NCT01388920|Secondary|Change From Baseline in Patient-reported Outcomes at 6 Months||6 months||||||
44897|NCT01388920|Secondary|Change From Baseline in Peripheral Muscle Strength at 6 Months||6 months||||||
44898|NCT01388920|Secondary|Change From Baseline in Exercise Capacity at 6 Months||6 months||||||
44899|NCT01388920|Primary|Change From Baseline in Lean Body Mass at 6 Months|The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan|6 months|The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.|||||
44900|NCT01388907|Secondary|mAFS Abdominopelvic Adhesion Score|mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome).|10 to 20 weeks post surgery|||units on a scale||Standard Deviation|Mean
44901|NCT01388907|Secondary|Adnexal Adhesions|Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980’s by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome).|10 to 20 weeks post surgery|||units on a scale||Standard Deviation|Mean
44902|NCT01388907|Secondary|Fertility|Fertility was assessed by pregnancy and deliveries rates at 3 years.|3 years|||participants|||Number
44903|NCT01388907|Primary|Number of Patients With Adhesions to Uterine Scars|"The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy.~This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand."|10 to 20 weeks post surgery|Two patients in group Prevadh group were withdrawn from the study, at 1 and 6 days post-myomectomy. One patient was re-operated for compress removal in Prevadh group and was excluded. Two patients in group Lactate Ringer group were withdrawn from the study, at 1 and 6 days post-myomectomy.||participants|||Number
44904|NCT01388816|Secondary|Changes in Other Lipids and Apolipoproteins|Change from baseline (LOCF, ITT population)|28 days|ITT with LOCF||percentage change from baseline||95% Confidence Interval|Least Squares Mean
44909|NCT01388816|Primary|Percent Change in HDL-C From Baseline|Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia|28 days|Intention to treat (ITT) analysis with last observation carried forward (LOCF) for missing data.||percent change from baseline||95% Confidence Interval|Least Squares Mean
44910|NCT01388790|Secondary|Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment.|Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.||months||95% Confidence Interval|Median
44911|NCT01388790|Primary|Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 [RECIST v 1.0] criteria).|Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.||percentage of participants||95% Confidence Interval|Number
44912|NCT01388647|Other Pre-specified|Dose Limiting Toxicity (DLT)|DLT is defined as grade 4 thrombocytopenia; grade 4 anemia; grade 4 neutropenia lasting > 5 days; or any grade 3 or 4 non-hematologic toxicity occurring during Cycle 1 which is attributable to eribulin, carboplatin, trastuzumab or the combination, or the inability to deliver all three agents at the assigned dose and scheduled time during Cycle 1.The following events are excluded from the DLT definition: grade 3 nausea and/or vomiting responsive to antiemetics; grade 3 fever or infection; grade 3 diarrhea responsive to antidiarrheal therapy.|Approximately 22 days from study treatment start, per subject|||participants|||Number
44913|NCT01388647|Other Pre-specified|Maximum Tolerated Dose (MTD) of Eribulin in Combination With Carboplatin and Trastuzuamb|The MTD is defined as the dose at which <= 1 of 6 subjects experience DLT (Dose Limiting Toxicity) and above which >= 2 of 6 subjects experience DLT.|Approximately 22 days from study treatment start, per subject|The MTD of ECH as neoadjuvant therapy for HER2+ breast cancer was determined per protocol definitions; however, due to the combination of increased hematologic toxicity and possible reduced efficacy, Phase II of this trial was not initiated.||mg/m^2|||Number
44914|NCT01388647|Secondary|Clinical Response|Clinical assessment of response will be performed 3 weeks after completion of study treatment. The treating physician will assess clinical response using physical examination and radiologic evaluation. Clinical response options are complete response (no invasive tumor in breast and lymph nodes), partial response (> 50% reduction in longest diameter of pretreatment tumor), no response (< 50% response to 10% growth of tumor as determined by longest diameter of pretreatment tumor size), and progression.|Assessed prior to definitive surgery, approximately 18 weeks from study treatment start.|||percentage of participants||95% Confidence Interval|Number
44915|NCT01388647|Primary|Pathologic Response|Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).|Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start|||percentage of participants||95% Confidence Interval|Number
44916|NCT01388530|Secondary|Attention Network Task - Incongruent Reaction Time|"Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network.~Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who completed 4 weeks of treatment, but comparison is based on Week 8 vs. baseline.||milliseconds (ms).||Standard Deviation|Mean
44917|NCT01388530|Secondary|Conners Global Index - Parent|"A standard, parent completed measure of ADHD symptoms.~Scale range from 0 (best) to 27 (worst).~Unit of Measure - units on a scale.~Outcome value reflects change from baseline at endpoint (Week 8)."|Baseline and Week 8.|Participants with data at baseline and week 4. We required 4 weeks treatment to include in analysis, but analysis is based on comparison of baseline and week 8.||units on a scale||Standard Deviation|Mean
44918|NCT01388530|Secondary|Clinical Global Impression - Improvement (CGI-I)|"A global measure of clinical improvement compared with baseline.~A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse).~Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others."|Week 8|Participants with data at baseline and week 4. As with the ADHD-RS, we included participants with at least 4 weeks of treatment, but outcome was assessed at Visit 8 compared with baseline.||percentage of improved|||Number
44919|NCT01388530|Primary|ADHD-IV Rating Scale (ADHD-RS)|"A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms.~Scale ranges from 0 (best) to 54 (worst).~Unit of Measure - units on a scale.~Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who participated in 4 weeks of treatment, but change comparison is baseline vs. week 8.||units on a scale||Standard Deviation|Mean
44920|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin|Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||nmol/L||Standard Error|Least Squares Mean
45612|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 weeks|All subjects||participants|||Number
44921|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)|Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||mIU/L||Standard Error|Least Squares Mean
44922|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol|Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||nmol/L||Standard Error|Least Squares Mean
44923|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin|Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||mg/L||Standard Error|Least Squares Mean
44924|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||ratio||Standard Error|Least Squares Mean
44925|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||ratio||Standard Error|Least Squares Mean
44926|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII|Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
44927|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII|Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
44928|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity|Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
44929|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin|Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
44930|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity|The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
44931|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen|The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||percentage of normal||Standard Error|Least Squares Mean
44932|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer|Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||mcg/L||Standard Error|Least Squares Mean
44933|NCT01388491|Primary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels|Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per-protocol (PP) population. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.||pmol/L||Standard Error|Least Squares Mean
44934|NCT01388361|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL).|Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator||events|||Number
44935|NCT01388361|Secondary|Change From Baseline in Body Weight|Corresponds to the values of change in body weight in kilograms from baseline to week 26.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period and missing data was imputed using LOCF. At baseline, the body weight values were missing for 1 subject in IDeg + Liraglutide arm from FAS and 3 subjects in NAS for IDeg arm.||kg||Standard Deviation|Mean
44936|NCT01388361|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Values for change in FPG in mmol/L from baseline to week 26 of randomised period.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period. The FPG values were missing for 7 subjects in FAS (2 subjects with IDeg+ liraglutide; 5 subjects with IDeg+IAsp arm) and 10 subjects in NAS for IDeg arm at baseline. The missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
44937|NCT01388361|Primary|Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)|Values for change in HbA1c from baseline to 26 weeks of treatment period.|week 0, week 26|The FAS and NAS included all randomised and non-randomised subjects respectively, and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
44938|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence.|12 months and baseline|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.||units on a scale||Standard Deviation|Mean
44939|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months.|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence.|6 months and 12 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months.||units on a scale||Standard Deviation|Mean
46410|NCT01367860|Secondary|VAS for Leg Pain - 1st Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery|||units on a scale||Standard Deviation|Mean
44940|NCT01388166|Primary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|Baseline and 6 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.||units on a scale||Standard Deviation|Mean
44941|NCT01387789|Secondary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
44942|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|Participants with available data at this time point||centimeters||Standard Deviation|Mean
44943|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
44944|NCT01387789|Secondary|Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
44945|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|Participants with available data at this time point||centimeters||Standard Deviation|Mean
44946|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|||units on a scale||Standard Deviation|Mean
44947|NCT01387789|Primary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
44948|NCT01387789|Primary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months|||centimeters||Standard Deviation|Mean
44949|NCT01387789|Primary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
44950|NCT01387737|Secondary|Change in Blood Pressure||Week 52||||||
44951|NCT01387737|Secondary|Change in Body Weight||Week 52||||||
44952|NCT01387737|Secondary|Change in Fasting Plasma Glucose||Week 52||||||
44953|NCT01387737|Secondary|Change in HbA1c||Week 52||||||
44954|NCT01387737|Primary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events||54 weeks|||percentage of incidences|||Number
44955|NCT01387672|Secondary|Headache|"Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from 0 to 10. A vertical line marked at 0 means no headache (score recorded = 0), a vertical line marked at 10 means a terrible headache (score recorded = 10)."|Run-in phase - 2 days|The mean headache score considering all subjects in each of the treatment/formulation group was calculated.||score on a scale||Standard Deviation|Mean
44956|NCT01387672|Primary|Bone Turnover Markers|"Markers of Bone Formation:~Serum Procollagen type 1 amino- terminal propeptide (P1NP)~Serum Osteocalcin (OC)~Serum Bone-specific alkaline phosphatase (BALP)~Markers of Bone Resorption:~- Serum C-telopeptides of collagen cross-links (CTX)"|3 months|One subject from the Treatment Arm 3 had outlier bone turnover markers values and was excluded from the analysis. Total number of subjects analyzed in Treatment Arm 3 was therefore 32.||Percent change from baseline||Standard Deviation|Mean
44957|NCT01387581|Primary|Specificity|"Dermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called Negative."|Within 120 days of Data Lock|||percent of true negatives||95% Confidence Interval|Mean
44958|NCT01387581|Primary|Sensitivity|"Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called Positive."|Within 120 days of Data Lock|||percent of true positives||95% Confidence Interval|Mean
44959|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
44960|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 6|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
44961|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 2|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
44962|NCT01387542|Primary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening ."|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.||Units on a scale||Standard Deviation|Mean
44964|NCT01387347|Secondary|Number of Adverse Events as a Measure of Safety and Tolerability|The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.|Throughout the study till Day 29|Intention to treat (ITT)||Events|||Number
44965|NCT01387347|Primary|Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye.|"Dry eye causes ocular discomfort, which is measured using a validated 4-point ORA Scale from the start of the dosing till the end of treatment (Day 29). 0 = no discomfort to 4 = constant discomfort.~If the measurement is lower, then improvement of ocular discomfort can be inferred. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29.~Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes had were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat (ITT)||Units on a Scale||Standard Deviation|Mean
44966|NCT01387347|Primary|Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye|"This is a test that uses orange dye (fluorescein) and a blue light to detect ocular surface defects associated with dry eye. If the test result is normal, the dye remains in the tear film on the surface of the eye and does not adhere to the eye itself. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. The scale used to determine the difference in corneal fluorescein staining between RGN-259 and placebo is the ORA scale: 0= no staining (no detectable ocular defect)to 4= confluent staining( severe ocular defect).~Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat population||units on a scale||Standard Deviation|Mean
44967|NCT01387230|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours Post-dose at Days 1 and 84 (Week 12)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 measurements of interest for Day 1 were collected at 1, 3, 6, 23 and 24 hours post-dose on Day 1 and for Day 84, the measures were pre-dose (24 hours post-dose of Day 83 morning dose but prior to Day 84’s dose) and 1, 3, 6, 23 and 24 hours post dose on Day 84. Baseline is the mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis performed separately by Visit/Day using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, time, time by Baseline and time by treatment interactions.|Baseline, Day 1 and Day 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
44968|NCT01387230|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Days 1, 28 (Week 4) and 84 (Week 12)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, and Day 84 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 1 hour, 3 hours, and 6 hours. Change from Baseline was the WM minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Days 1, 28 and 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
44969|NCT01387230|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56, 84, and 85. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 84). Change from Baseline was calculated as the trough FEV1 minus the Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all randomized par. who received >=1 dose of study drug. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
44970|NCT01387178|Secondary|Number of COPD-related Healthcare Encounters||1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007||number of encounters|||Number
44971|NCT01387178|Primary|Mean Number of COPD Exacerbations|Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.|1 year|The total population including participants with index dates between January 1,2004 and June 30, 2008.||number of exacerbations||Standard Deviation|Mean
44972|NCT01387178|Primary|Post-index Period COPD-related, Unadjusted Costs|The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.|1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007||United States (US) dollars||Standard Deviation|Mean
44973|NCT01387139|Secondary|Nurse Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour|||units on a scale||Inter-Quartile Range|Median
44974|NCT01387139|Secondary|Physician Performing Procedure Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour|||units on a scale||Inter-Quartile Range|Median
44975|NCT01387139|Secondary|Parent Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour|||units on a scale (1-10)||Inter-Quartile Range|Median
44976|NCT01387139|Secondary|Efficacy of Sedation|"Efficacy is defined as:~The patient does not have unpleasant recall of the procedure.~The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation~The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.~The procedure was successful"|After procedure is completed, on average less than 1 hour|||participants|||Number
44977|NCT01387139|Secondary|Recovery Time|Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.|Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour|||minutes||Inter-Quartile Range|Median
44978|NCT01387139|Primary|Frequency of Adverse Events|We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.|From enrollment through completion of follow-up, up to 7 days|Adverse events||participants|||Number
44979|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
44980|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
44981|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
44982|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
44993|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham|The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.|20 weeks|All subjects with available fasting and and 2-hour insulin measurements are included.||iIU/dL||Standard Deviation|Mean
44983|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
44984|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
44985|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.||Participants|||Number
44986|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.||Participants|||Number
44987|NCT01386008|Secondary|Investigator Fit Preference|Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.||participants|||Number
44988|NCT01386008|Primary|Ocular Health|Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.|Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. Change from baseline V1 over 30 days V4 cannot be analyzed.|||||
44989|NCT01386008|Primary|Subjective Comfort Preference - Participants Preference Response|Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.||participants|||Number
44990|NCT01386008|Secondary|Investigator Surface Preference|Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.||participants|||Number
44991|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham|Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity.|20 Weeks|||units on a scale||Standard Deviation|Mean
44992|NCT01385995|Secondary|Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP|20 weeks|All subjects with available fasting insulin, glucose measurements||percentage of beta cell function||Standard Deviation|Mean
44995|NCT01385995|Primary|Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)|Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL)|20 weeks|All available oral glucose tolerance test data was analyzed for the total sample.||subjects|||Number
44996|NCT01386983|Secondary|Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month|EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.|3 months prior to and 12 months following index date|Enrolled Population||dollars||95% Confidence Interval|Mean
44997|NCT01386983|Primary|Number of Participants With Clinical Progression|Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.|3 months prior to and 12 months following index date|Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID.||participants|||Number
44998|NCT01386944|Secondary|Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study|Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians’ discretion.|From Baseline up to 28 days|The Analysis Population refers to the Eligibility Completer Set (ECS). The ECS is a subset of the Completer Set excluding patients with Parkinson’s disease and/or treated Polyneuropathy as concomitant disease identified by the preferred term (PT) of the MedDRA coding and patients treated with Neupro up to 4 weeks before Visit 1.||participants|||Number
44999|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1."|From Baseline up to 13 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
45000|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1."|From Baseline up to 10 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
45001|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
45002|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1."|From Baseline up to 4 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
45003|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1."|From Baseline up to 28 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
45004|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.||score on a scale||Standard Deviation|Mean
45005|NCT01386788|Primary|Serum Cyanide Levels||blood sampling within 2 hours after smoke inhalation|All recruited patients that met all inclusion criteria including blood sampling for cyanide serum level||participants|||Number
45006|NCT01386788|Primary|Overall Survival After 24 Hours|Number of participants who survived at 24 hours after smoke inhalation were reported.|24 hours|||participants|||Number
45007|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.|The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).|Week 6|PK population||ng*h/mL||Standard Deviation|Mean
45008|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.|The Tmax for plasma concentration.|Week 6|PK population||h||Standard Deviation|Mean
45009|NCT01386606|Secondary|Change in Follicle Stimulating Hormone (FSH)|Changes in morning FSH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.||mIU/mL||Standard Deviation|Mean
45010|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.|The Cmax for plasma concentration.|Week 6|PK population||ng/mL||Standard Deviation|Mean
45011|NCT01386606|Post-Hoc|Morning Testosterone Correlated With Serial Testosterone.|"9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.~If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation."|Week 6|All Androxal subjects with Week 6 serial testosterone measurements.||Number of Subjects|||Number
45012|NCT01386606|Secondary|Change in Leuteinizing Hormone (LH)|Changes in morning LH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.||mIU/mL||Standard Deviation|Mean
45013|NCT01386606|Primary|24 Hour Average and Maximum Testosterone Concentration|"The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.~Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24."|Baseline and Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.||ng/dL||Standard Deviation|Mean
45014|NCT01386125|Primary|Change From Baseline in Total Polyp Size Score|An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.||score on a scale||Standard Error|Least Squares Mean
45015|NCT01386125|Primary|Change From Baseline in Congestion/Obstruction Score|At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.|Baseline and Weeks 1-4|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.||score on a scale||Standard Error|Least Squares Mean
45016|NCT01385696|Secondary|Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2|"The correct use of devices will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice (visit 2).~Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose."|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.||Percentage of Patients|||Number
45017|NCT01385696|Secondary|Mean Overall Satisfaction With Genuair and Handihaler at Visit 2|The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 5 [very satisfied]) after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.||Units on a scale (1-5)||95% Confidence Interval|Mean
45125|NCT01383499|Secondary|Mean Evening PEF Response|Mean Evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||Litre/min||Standard Error|Least Squares Mean
45018|NCT01385696|Primary|Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2|Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data was handled via the observed cases approach.||Percentage of Patients|||Number
45019|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline|DLCO was measured as a percentage of predicted, and the percentage change between 6 months post-infusion and baseline is reported.|6 months post MSC infusion|||percentage of baseline||Inter-Quartile Range|Median
45020|NCT01385644|Secondary|Percentage Change in 6 Minute Walk Distance Compared to Baseline|At 6 months 6 Minute Walk Distance was mesured and compared as a percentage to baseline|Baseline and 6 months post MSC infusion|||percentage of baseline||Inter-Quartile Range|Median
45021|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by FVC Compared to Baseline|Forced Vital Capacity (FVC) was measured and reported as a percentage of predicted and comapred from 6 months post-infusion to baseline|6 months post MSC infusion|||percentage of baseline||Inter-Quartile Range|Median
45022|NCT01385644|Primary|Number of Participants Who Demonstrated Acute Adverse Events Following Infusion|Acute adverse events following infusion was defined as the development of anaphalaxis and/or a 25% increase or decrease from baseline of hemodynamic measurements.|4 hours post-infusion|Data from 8 participants was analyzed. (4 from each group)||participants|||Number
45023|NCT01385579|Primary|Completion of a Colorectal Cancer Screening|Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)|within 4 months of the initiation of outreach (by June 30, 2010)|||participants|||Number
45024|NCT01385566|Primary|Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)|Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
45025|NCT01385566|Primary|Number of Participants Reporting Systemic Adverse Experiences|Systemic AEs included all reported AEs except injection-site AEs|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
45026|NCT01385566|Primary|Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)|The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.|Up to 5 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||Participants|||Number
45027|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention|Within 5 days after the blood draw at approximately 20 months following vaccine administration|The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up||Participants|||Number
45028|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience (SAE)|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
45029|NCT01385566|Primary|Number of Participants Reporting an Adverse Experience (AE)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination||participants|||Number
45030|NCT01385566|Primary|Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies|VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.|Baseline and 6 weeks following vaccine administration|The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.||Geometric mean fold change||90% Confidence Interval|Geometric Mean
45031|NCT01385371|Secondary|Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)|For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants <12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.entry.||score on a scale||Full Range|Median
45032|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Peak GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Standard Error|Mean
45033|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Peak GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
45034|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Entire GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Standard Error|Mean
45035|NCT01385371|Secondary|Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS|The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants ≥12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
45036|NCT01385371|Secondary|Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.~For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.~For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
45037|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Entire GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
45038|NCT01385371|Primary|Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.~For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.~For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Entire GPS (expected average duration of 5 to 6 weeks)|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.||score on a scale||Full Range|Median
45039|NCT01385202|Secondary|Rate of Acute Success|Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).|End of procedure|The analysis population for this endpoint includes two groups; a): Calibration Roll-in subjects who were prospectively identified prior to the study procedure and b) the Effectiveness Cohort. Both groups underwent an AF ablation procedure with the study catheter.||percentage of participants|||Number
45040|NCT01385202|Primary|Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.|Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.|7 days of the AF ablation procedure|Safety cohort includes all enrolled subjects who had the study catheter inserted.||Percentage of patients with primary AE||95% Confidence Interval|Number
45184|NCT01382251|Secondary|Short Form 12|A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
45041|NCT01385202|Primary|The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up|The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).|12-months|Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia.||percentage of participants||95% Confidence Interval|Number
45042|NCT01385033|Primary|Amyloid Plaque Burden Threshold Determined by the Trimmed HE Sample Mean and SD Brain Cortical [18F]MK-3328 SUVR|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and SD (trimmed). This step is performed to remove HE participants with positive plaque burden. Using HE data, the threshold for classification of plaque burden as positive/negative will be calculated as mean (trimmed) + k*SD (trimmed). Value of k will be chosen to fine tune sensitivity/specificity, with specificity of at least 0.9 in the sub-group remaining after trimming of data.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of an amyloid plaque burden threshold using PET imaging data obtained after [18F]MK-3328 administration was not performed.|||||
45043|NCT01385033|Primary|Brain Cortical [18F]MK-3328 SUVR in AD Participants and HE Participants|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulated gyrus, posterior cingulated gyrus, temporal cortex, lateral temporal cortex and occipital cortices). A trimming procedure will be applied to remove the sub-population of HE participants who have positive amyloid plaque burden. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and standard deviation (SD)(trimmed).|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of brain cortical [18F]MK-3328 SUVR values in AD and HE participants was not performed.|||||
45044|NCT01385033|Primary|Area Under the Receiver Operating Curve (AUC of ROC) for Distinguishing Between AD and HE Participants Based on Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR)|Using PET brain images acquired after dosing, regions of interest (ROIs) are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue time-activity curves (TACs). SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices). The receiver operating curve (ROC) for determining whether a participant is in HE or AD group by using cortical SUVR values is determined. The ROC is a plot of sensitivity on the y-axis versus 1-specificity (false positive rate) on the x-axis for the range of cortical SUVR threshold values. The AUC of ROC is determined.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the potential of [18F]MK-3328 to distinguish between AD and HE participants was not assessed.|||||
45045|NCT01384760|Secondary|Epworth Sleepiness Score (ESS)|The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness. It was first described in 1991 as a simple, self-administered questionnaire. The questionnaire is based on eight common situations in life. Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances. This gives a total score of 0 to 24 in each subject.The total score ranges from 0 to 24, with higher scores indicating higher sleepiness.|1 year|||units on a scale||Standard Deviation|Mean
45046|NCT01384760|Primary|Apnea-hypopnea Index (AHI) at One Year|AHI is a count of the number of upper airway obstruction per hour of sleep. The index will be derived from the overnight home sleep study.|1 year|||events per hour||Standard Deviation|Mean
45047|NCT01384292|Primary|Response (Responder/Non-responder) to Study Drug|Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.|Baseline to Week 4|All randomized patients||Participants|||Number
45048|NCT01384019|Secondary|Reperfusion Success|microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR|3-5 days||||||
45049|NCT01384019|Primary|Postinfarct Remodeling|postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI|6 months|Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group.||Number of participants with remodeling|||Number
45050|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
45291|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45051|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
45052|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
45053|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
45054|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
45055|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
45056|NCT01383993|Secondary|Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration|Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration|AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Mean
45057|NCT01383993|Primary|Number of Participants Assessed Visual Questionnaire||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.||participants|||Number
45058|NCT01383993|Primary|Number of Participants Assessed Color Vision Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.||participants|||Number
45059|NCT01383993|Primary|Number of Participants Assessed Near Distance Visual Acuity Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.||participants|||Number
45060|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
45061|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
45062|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
45063|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||hrs||Full Range|Median
45064|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
45065|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
45066|NCT01383928|Secondary|Phase 2: Overall Survival|Overall survival was measured as the time from the date of first dose of study treatment to the time of death plus 1 day. For participants who did not die, survival was censored at the date of last contact. Overall Survival was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline up to treatment cycle 35|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||months||95% Confidence Interval|Median
45067|NCT01383928|Secondary|Phase 2: Percentage of Participants Achieving Survival at Year 1||1 year after the first dose of study treatment|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||participants||95% Confidence Interval|Number
45068|NCT01383928|Secondary|Phase 2: Progression Free Survival (PFS)|PFS was defined as the time from the date of first dose of study treatment to the date of first documentation of progressive disease or to death due to any cause, whichever occurred first plus 1. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved,uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants who received ASCT or an alternate anticancer therapy were censored at the last response assessment that was SD or better before initiation of therapy. Participants without a response assessment were censored at the date of first dose. PFS was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline until progressive disease (up to treatment cycle 35)|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||months||95% Confidence Interval|Median
45069|NCT01383928|Secondary|Phase 2: Time to Disease Progression (TTP)|Time to progression was defined as the time from the date of first dose of study treatment to the date of first documentation of PD + 1 day. Participants that did not experience PD will be censored at the last response assessment that is SD or better. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants that received Autologous Stem Cell Transplantation (ASCT) or an alternate cancer therapy were also be censored at the last response assessment that is, SD or better prior to initiation of therapy. Participants without response assessment will be censored at the date of first dose. TTP was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline until progressive disease (up to treatment cycle 35)|modified-intent-to-treat (mITT) population included all participants who received at least one dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.||months||95% Confidence Interval|Median
45070|NCT01383928|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as >=25% increase from lowest value in: serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; development of new bone lesions or soft tissue plasmacytomas development or increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcaemia development.|Baseline until end of study treatment (up to treatment cycle 35)|Included a subset of response-evaluable population who achieved response.||months||95% Confidence Interval|Median
45071|NCT01383928|Secondary|Phase 2: Time to Response|Time to first response is defined as the time from the date of first dose of study treatment to the date of the first documentation of a confirmed response (PR or better) in a participant who responded + 1 day. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.||months||Full Range|Median
45072|NCT01383928|Primary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.||percentage of participants|||Number
45073|NCT01383928|Primary|Phase 2: Percentage of Participants Experiencing Serious Adverse Events|A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least one dose of any study drug.||percentage of participants|||Number
45074|NCT01383928|Secondary|Phase 2: Percentage of Participants With Minimal Response (MR)|MR as per IMWG criteria is 25%-49% reduction in serum paraprotein and 50%-89% reduction in urine light chain excretion for 6 weeks.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45075|NCT01383928|Secondary|Phase 2: Percentage of Participants With Partial Response (PR)|PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45076|NCT01383928|Secondary|Phase 2: Percentage of Participants With Near Complete Response (nCR)|nCR as per IMWG criteria is positive immunofixation analysis of serum or urine as the only evidence of disease; appearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45077|NCT01383928|Secondary|Phase 2: Percentage of Participants With Very Good Partial Response (VGPR)|VGPR as per IMWG criteria is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45078|NCT01383928|Secondary|Phase 2: Percentage of Participants With Stringent Complete Response (sCR)|sCR as per IMWG criteria is CR plus normal FLC ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45079|NCT01383928|Secondary|Phase 2: Pecentage of Participants With Complete Response (CR)|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45080|NCT01383928|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) After Cycles 4, 8, and 16|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR were applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein; Urine M-protein; Serum FLC assay.|Cycles 4, 8, and 16|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45081|NCT01383928|Secondary|Phase 2: Percentage of Participants With Objective Response|Objective response is defined as CR, VGPR or PR based on IMWG Response Criteria for malignant lymphoma. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein+urine M-protein level <100 mg/24h. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes.|Baseline until end of study treatment (up to Cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
45082|NCT01383928|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. As per Common Terminology Criteria for Adverse Events v4.0 (CTCAE), Grade 3 = AE with severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = AE with life-threatening consequences; urgent intervention indicated and Grade 5 = Death related to AE.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.||percentage of participants|||Number
45083|NCT01383928|Primary|Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR)|CR as per International Myeloma Working Group (IMWG) uniform criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR was applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein greater than or equal to (>=)1 g/dL; Urine M-protein >=200 mg/24 hours; Serum FLC assay level >=10 mg/dL, provided serum FLC ratio was abnormal.|Baseline up to treatment cycle 35|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
45084|NCT01383928|Primary|Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure and heart rate.|Baseline and Day 1 of each treatment cycle up to 35 treatment cycles|Safety population included all participants who received at least 1 dose of any study drug.||participants|||Number
45085|NCT01383928|Primary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity|TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.||participants|||Number
45086|NCT01383928|Primary|Phase 1: Number of Participants With Change From Baseline Value in Clinical Laboratory Test Results to Worst Value|Number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology (white blood cell [WBC] count, lymphocytes, neutrophils, platelets, hemoglobin), clinical chemistry and urinalysis were performed. Number of participants with baseline laboratory values as per National Cancer Institute Common Terminology Criteria (NCI CTC) grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes to the worst CTC grade were presented. Baseline value defined as value collected at time closest to, but prior to, first dose of study drug on Cycle 1 Day 1. Worst post-baseline value defined as worst value between first dose of any study drug and End of Study (EOS) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for corrected calcium, glucose, magnesium, potassium and sodium irrespective of change in the CTC grade.|Baseline and Cycle 1 up to Cycle 35|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.||participants|||Number
45087|NCT01383928|Secondary|Phase 1: Percentage of Participants With Best Overall Response|Best response observed during study.CR:no immunofixation on serum,urine;soft tissue plasmacytomas disappearance;<5% plasma cells in bone marrow.Stringent CR(sCR):CR as defined,normal free light chain ratio,absence of clonal cells in bone marrow.Partial response(PR):>=50% reduction of serum M-protein,urinary M-protein by >=90%/to <200 mg/24 hr reduction.Near CR(nCR):positive immunofixation of serum/urine;soft tissue plasmacytomas disappearance;<=5% plasma cells in bone marrow.VGPR:serum,urine M-protein detectable by immunofixation but not on electrophoresis/>=90% reduction in serum M-protein+urine M-protein level <100 mg/24hr.Stable disease (SD):failure to attain CR,VGPR,PR/progressive disease (PD).PD:>=25% increase from lowest value in:serum/urine M-component;difference between involved,uninvolved FLC levels;bone marrow plasma cell percent;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise;hypercalcaemia development.|Baseline until end of study treatment (up to Cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment. Results were summarized together for all Phase 1 participants, as per planned analysis. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
45088|NCT01383928|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC (0-72) on Day 11 to the AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||ratio||Standard Deviation|Geometric Mean
45089|NCT01383928|Secondary|Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||hours||Full Range|Median
45090|NCT01383928|Secondary|Phase 1: AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib|AUC(0-72) is a measure of the area under the plasma concentration time-curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
45091|NCT01383928|Secondary|Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|Pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
45092|NCT01383928|Primary|Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.||percentage of participants|||Number
45093|NCT01383928|Primary|Phase 1: Recommended Phase 2 Dose (RP2D)|The RP2D of ixazomib was determined after the evaluation of the available data from the phase 1 portion of the trial which included, but was not limited to analyses of efficacy results, toxicity characterization, all grades peripheral neuropathy, and treatment discontinuation.|Cycle 1 up to Cycle 35|Safety population included all participants who received at least 1 dose of any study drug.||mg|||Number
45113|NCT01383720|Primary|Clinical Procedural Success|Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.|Discharge or 7 days post-procedure, whichever comes first|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis||participants|||Number
45126|NCT01383499|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||Litre/min||Standard Error|Least Squares Mean
45094|NCT01383928|Primary|Phase 1: Maximum Tolerated Dose (MTD)|MTD was highest dose of ixazomib given with combination drugs, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >14 days; <=80% lenalidomide doses administered due to other >=Grade 2 combination study drug-related nonhematologic toxicities requiring therapy discontinuation.|Cycle 1|DLT-evaluable population included all participants who received all Cycle 1 doses of MLN9708 and completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in Phase 1.||mg|||Number
45095|NCT01383720|Other Pre-specified|Acute Kidney Injury - Stage 2 or 3|"Stage 2: Increase in serum creatinine to 200-300% (2.0-3.0 times increase compared with baseline).~Stage 3: Increase in serum creatinine to ≥ 300% (> 3 times increase compared with baseline) or serum creatinine of ≥ 4.0 mg/d (≥ 354 μmol/L) with an acute increase of at least 0.5 mg/dl (44 μmol/L). Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria."|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45096|NCT01383720|Other Pre-specified|Bleeding|"Life-threatening or Disabling Bleeding~Fatal bleeding OR~Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR~Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR~Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units~Major Bleeding~Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC AND~Does not meet criteria of life-threatening or disabling bleeding"|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45097|NCT01383720|Other Pre-specified|New Conduction Disturbances or Arrhythmias Requiring Permanent Pacemaker||Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45098|NCT01383720|Other Pre-specified|Major Vascular Complication|"Any thoracic aortic dissection~Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, or compartment syndrome) leading to either death, need for significant blood transfusions (≥4 units), unplanned percutaneous or surgical intervention, or irreversible end-organ damage (e.g. hypogastric artery occlusion causing visceral ischemia or spinal artery injury causing neurologic impairment)~Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage"|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45099|NCT01383720|Other Pre-specified|Urgent/Emergent Conversion to Surgery or Repeat Procedure for Valve-related Dysfunction||Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45100|NCT01383720|Other Pre-specified|Major Stroke|Confirmed with a Modified Rankin score >/= 2 at 30 and 90 days|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45101|NCT01383720|Other Pre-specified|Peri-procedural Myocardial Infarction|"Peri-Procedural Myocardial Infarction (≤72 hours after the index procedure)~New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs (e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, or imaging evidence of new loss of viable myocardium or new wall motion abnormality), AND~Elevated cardiac biomarkers (preferably creatine kinase-myoglobin band) within 72 h after the index procedure, consisting of two or more post-procedure samples that are > 0.6 to 8 h apart with a 20% increase in the second sample and a peak value exceeding 10X the 99th percentile upper reference limit (URL), or a peak value exceeding 5X the 99th percentile URL with new pathological Q waves in at least 2 contiguous leads"|72 hours|||participants|||Number
45102|NCT01383720|Other Pre-specified|Death||Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45103|NCT01383720|Other Pre-specified|Aortic Valve Area|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||cm^2||Standard Deviation|Mean
45104|NCT01383720|Other Pre-specified|Mean Aortic Valve Gradient|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||mm Hg||Standard Deviation|Mean
45105|NCT01383720|Other Pre-specified|No Major Adverse Cardiovascular and Cerebrovascular Events Through Discharge|Major adverse cardiovascular or cerebrovascular events include all-cause mortality, periprocedural myocardial infarction ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45106|NCT01383720|Other Pre-specified|Single Valve Implanted in the Proper Anatomical Location||procedure|||participants|||Number
45107|NCT01383720|Other Pre-specified|Intended Performance of the Lotus Valve|Aortic valve area >1.0 cm2 plus either a mean aortic valve gradient <20 mmHg or peak velocity <3m/sec, without moderate or severe prosthetic valve aortic regurgitation|At time of discharge or 7 days post procedure|||participants|||Number
45108|NCT01383720|Other Pre-specified|Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System||Procedure|||participants|||Number
45109|NCT01383720|Secondary|Paravalvular Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45110|NCT01383720|Secondary|Central Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first|||participants|||Number
45111|NCT01383720|Secondary|Device Performance Endpoint-Valve Retrieval, if Attempted|Successful retrieval of the Lotus Valve System if retrieval is attempted|procedure|||participants|||Number
45112|NCT01383720|Secondary|Device Performance Endpoint-Repositioning|Successful repositioning of the Lotus Valve System if repositioning is attempted|procedure|Patients in whom repositioning of the Lotus Valve was attempted||participants|||Number
45292|NCT01380730|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45114|NCT01383707|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first study drug administration to the date of death due to any cause. Participants who were alive at the time of the analysis were censored at the last date the participant was known to be alive. OS was calculated as follows: OS (months) = ([Date of Death - first study drug administration] + 1)/30|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||months||95% Confidence Interval|Median
45115|NCT01383707|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first study drug administration to the date of disease progression or death due to any cause, whichever came first. Progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants, who did not progress were censored at the date of the last assessment performed. Participants who withdrew from the study without documented progression and for whom an electronic case report form (eCRF) existed as evidence that evaluations had been made, were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessments, but known to be alive were censored at the time of first study drug administration. PFS was calculated: PFS (months) = ([Date of Event - Date of first study drug administration] + 1)/30.|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||months||95% Confidence Interval|Median
45116|NCT01383707|Secondary|Disease-free Interval (DFI)|"DFI was defined as the time from the date of R0/R1 surgery to the date of disease relapse or death due to any cause. Participants who did not progress were considered censored at the date of the last assessment performed. For participants receiving two-stage resection, the date of R0/R1 surgery was the date of the second surgery. Participants, who did not receive surgery and participants without R0/R1 surgery were censored at Day 1.~DFI was calculated as follows: DFI (months) = ([Date of R0/R1 surgery ‐ Date of 1st relapse/Death] + 1)/30"|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||months||95% Confidence Interval|Median
45117|NCT01383707|Secondary|Percentage of Participants Achieving No Residual Tumor (R0)/Surgical Margin With Microscopic Residual Tumor (R1) Liver Resection|The percentage of participants achieving R0/R1 liver resection was defined as the percentage of participants achieving R0 surgery (no residual tumor) plus percentage of participants achieving R1 surgery (surgical margin with microscopic residual tumor).|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||percentage of participants||95% Confidence Interval|Number
45118|NCT01383707|Primary|Objective Response Rate (ORR) in the Per-protocol Analysis Set (PPAS)|ORR was defined as the percentage of participants with shrinkage (PR) or disappearance of cancer (CR). Tumor response was evaluated according to the RECIST v1.1. The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of CT scan (abdomen + pelvis + chest) or CE-MRI (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The PPAS included all subjects in the ITT set, who did not experience any major protocol violations.||percentage of participants||95% Confidence Interval|Number
45119|NCT01383707|Primary|Objective Response Rate (ORR) in the Intent-to-treat (ITT) Analysis Set|ORR was defined as the percentage of participants with shrinkage (partial response [PR]) or disappearance of cancer (complete response [CR]). Tumor response was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of computerized tomography (CT) scan (abdomen + pelvis + chest) or contrast-enhanced magnetic resonance imaging (CE-MRI) (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.||percentage of participants||95% Confidence Interval|Number
45120|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Month 12|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.|||||
45121|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Baseline|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.|||||
45122|NCT01383499|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model. The scores for this question used the following scale where: 1='Did not wake up', 2='Woke up once', 3='Woke up 2-5 times', 4='Woke up more than 5 times' and 5='Was awake all night'.|Baseline and last week of treatment (week 4)|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||scores on a scale||Standard Error|Least Squares Mean
45123|NCT01383499|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with at least one on-treatment value.||Score||Standard Error|Least Squares Mean
45124|NCT01383499|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day (24 h, daytime and night-time use). Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."||Puffs||Standard Error|Least Squares Mean
45127|NCT01383499|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
45128|NCT01383499|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
45129|NCT01383499|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
45130|NCT01383499|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
45131|NCT01383499|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.||Litre||Standard Error|Least Squares Mean
45132|NCT01383499|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.||Litre||Standard Error|Least Squares Mean
45133|NCT01383486|Secondary|The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score </= 60 at visit 1.|Up to 14 days|Subgroup of Selection Evaluation Population: low literacy participants who had REALM score </= 60 at visit 1 and chose naproxen sodium.||Percentage of participants|||Number
45134|NCT01383486|Secondary|The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours||Within 24 hours of their selection decision taken up to 14 days|Subgroup of Selection Evaluation Population||Percentage of participants|||Number
45135|NCT01383486|Primary|The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).|up to 14 days|Only subjects who chose naproxen sodium were included in the analysis.||Percentage of participants|||Number
45136|NCT01383356|Secondary|Area Under the Curve 0 to Inf (AUC0-inf)|AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period||ng*h/ml||Standard Deviation|Mean
45137|NCT01383356|Primary|Area Under the Curve 0 to Last Measurable Value (AUC0-t)|AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period||ng*h/ml||Standard Deviation|Mean
45138|NCT01383356|Primary|Maximum Plasma Concentration (Cmax)|Maximum measured concentration of metformin in plasma, per period.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period.||ng/ml||Standard Deviation|Mean
45139|NCT01383213|Secondary|to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality|"The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of:~CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint~Control: patients randomised to Venturi mask treatment~Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP"|participants will be followed for the duration of hospital stay, an expected average of 4 weeks||||||
45183|NCT01382251|Secondary|Brief Pain Inventory (BPI) Functional Interference Score.|Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for “does not interfere” and 10 for “completely interferes.” The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
45140|NCT01383213|Primary|to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation.|"Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2<90%;Exhaustion.~The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician."|the reaching of the following endotracheal intubation criteria maintained for at least one hour:|||participants|||Number
45141|NCT01383200|Primary|Participants Score on Pain Scale|Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort|1 hour (60minutes) post LASIK operation|Five participants received tetracaine right eye and lidocaine left eye and six participants received lidocaine right eye and tetracaine left eye. A total of 22 eyes were analyzed for pain.||Score on scale|Participants|Standard Deviation|Mean
45142|NCT01383174|Secondary|Breast Cancer-Specific Distress of the Intrusive Thoughts Scale|Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45143|NCT01383174|Secondary|Somatization a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45144|NCT01383174|Secondary|Depression a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45145|NCT01383174|Primary|Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0–108. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45146|NCT01383174|Primary|Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to Enjoyment of Life. Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0–16. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45147|NCT01383174|Primary|Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0–28. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45293|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45148|NCT01383174|Primary|Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0–20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45149|NCT01383174|Primary|Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0–20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45150|NCT01383174|Secondary|Anxiety a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45151|NCT01383174|Primary|Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0–24. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.||units on a scale||Standard Deviation|Mean
45152|NCT01383096|Primary|OZ439 t1/2|Apparent terminal half life (t1/2)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.||hours||Geometric Coefficient of Variation|Geometric Mean
45153|NCT01383096|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
45154|NCT01383096|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
45155|NCT01383005|Secondary|Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies|Adherence to LPV/r QD therapy (overall study population of QD-KAPITAL) compared with that of LPV/r BID therapy using data of Cohort 2 from a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. (A full comparison of the adherence between the QD-KAPITAL study and the KAPITAL2 study could not be made due to formal differences in the applied adherence questionnaires; therefore, the above in-common specified item was compared.) Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data.||percentage of participants|||Number
45180|NCT01382719|Secondary|Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
45294|NCT01380730|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45156|NCT01383005|Secondary|Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies|Participants' perceptions of the QD and BID LPV/r regimens using data from the overall study population of QD-KAPITAL and from Cohort 2 of a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data. n=the number of participants with data for given dimension.||units on a scale||Standard Deviation|Mean
45157|NCT01383005|Secondary|Mean Number of Days on LPV/r QD|This independent variable was correlated with the percentage of participants with the dependent variable of an HIVTSQ Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analysis for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension||days||Standard Deviation|Mean
45158|NCT01383005|Secondary|Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)|Viral load change was categorized as either 'detectable to undetectable,' 'undetectable to undetectable,' or 'current detectable' (includes participants whose viral load changed from undetectable to detectable and those whose viral load was detectable throughout). This independent variable was correlated with the percentage of participants with the dependent variable of a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analyses for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension||participants|||Number
45159|NCT01383005|Secondary|Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions. The Overall Satisfaction dimension has a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10). The mean of the individual item scores were dichotomized as 'mean score <5 (lower participant perception of LPV/r QD)' and 'mean score ≥5 (high or very high participant perception of LPV/r QD).' The dependent variable of a mean score <5 was correlated with the independent variables of viral load and time on treatment (see Outcome Measures 9 and 10), to determine the factors associated with a participant's lower perception of QD LPV/r treatment.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants||percentage of participants|||Number
45160|NCT01383005|Secondary|Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen|Participants’ cumulative reasons for starting or switching to a LPV/r QD regimen were tabulated via the following yes/no questions entered on the case report form by the physician: simplification (simp) as reason to change to LPV/r QD; preference (pref) of patient as reason to change to LPV/r QD; adjustment to other antiretrovirals (adjust to ARV) as reason to change to LPV/r QD; adherence as reason to change to LPV/r QD; patient’s lifestyle as reason to change to LPV/r QD; tolerability as reason to change to LPV/r QD.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants||participants|||Number
45161|NCT01383005|Secondary|Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)|Participants' adherence was classified according to answers for 5 of 6 items on the participant questionnaire Simplified Medication Adherence Questionnaire (SMAQ): 4 yes/no questions: Do you ever forget to take your medicines? Do you take your medicines at the instructed time? If you ever feel ill, do you stop taking the medication? Have you ever missed your medication during weekends?; plus the following: In the past week, how many times have you missed your medication? (0, 1-2, 3-5, 6-10, >10). (Please see Outcome Measure 5 for details regarding the 6th item on the SMAQ.) Perfect adherence = no dose was forgotten, medication was not skipped for any reason, and the schedule was not modified; adequate adherence = no dose was forgotten, but at least one dose was not taken at the indicated time; poor adherence = one or more doses were not taken.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.||participants|||Number
45162|NCT01383005|Secondary|Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)|Number of days without medication was assessed by 1 of the 6 items on the patient questionnaire Simplified Medication Adherence Questionnaire (SMAQ): How many full days have you missed your medication since your last visit? (Please see Outcome Measure 6 for details regarding the remaining 5 items on the SMAQ.)|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.||participants|||Number
45163|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). The mean score per dimension was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
45295|NCT01380730|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
45164|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). Each dimension was considered for the evaluation of the primary outcome. For each participant, each dimension score was calculated as a sum of the individual item scores.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
45165|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The mean score per item was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
45166|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population|Participant treatment satisfaction was measured using the HIVTSQ, which consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). Each single item was considered for the evaluation of the primary outcome.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.||units on a scale||Standard Deviation|Mean
45167|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment.~The CTCAE includes the following severity descriptions:~“Moderate” means mild to moderate interference with the patient’s daily activities, no or minimal medical intervention/therapy required;~Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible.~If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.||percentage of participants||95% Confidence Interval|Number
45168|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion|"The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 (Mild) to Grade 5 (Death). Grade 3 AEs are Severe and Grade 4 AEs are Life-threatening, Disabling."|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.||percentage of participants||95% Confidence Interval|Number
45169|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment.~The CTCAE includes the following severity descriptions:~“Moderate” means mild to moderate interference with the patient’s daily activities, no or minimal medical intervention/therapy required;~Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible.~If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
45181|NCT01382719|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)|"The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = Yes minus the number of baseline events with FSEP-R Q10 = Yes. Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.|||SSEs||Standard Deviation|Mean
45170|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion|"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows:~Grade 3 means Severe, indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible.~Grade 4 means Life-threatening, Disabling, based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
45171|NCT01382940|Secondary|Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion|IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.||percentage of participants||95% Confidence Interval|Number
45172|NCT01382940|Secondary|Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion|A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
45173|NCT01382940|Primary|Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion|"The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). Incidence is defined as the percentage of participants experiencing an IRR."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.||percentage of participants||95% Confidence Interval|Number
45174|NCT01382901|Primary|International Restless Legs Syndrome (IRLS) Total Score|The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.|Change from Baseline to Day 28|Evaluable Population||Scores on a scale||Standard Deviation|Mean
45175|NCT01382719|Secondary|FSDS–DAO Total Score|"FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, How often do you feel: Distressed about your sex life and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
45176|NCT01382719|Secondary|Quality of Relationship With Partner as Measured by GAQ Question 4|"This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
45177|NCT01382719|Secondary|Satisfaction With Desire as Measured by GAQ Question 2|"This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
45178|NCT01382719|Secondary|Desire Domain From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
45179|NCT01382719|Secondary|Satisfaction With Arousal as Measured by GAQ Question 1|"This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)|||units on a scale||Standard Deviation|Mean
45182|NCT01382446|Primary|Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients|Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol.|18 Months|Intention to Treat Analysis Used||participants|||Number
45185|NCT01382251|Secondary|Zarit Burden Interview (ZBI)|"A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for never and 4 for nearly always. Scores range from 0-88 with higher scores indicating increased burden of care."|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
45186|NCT01382251|Primary|Functional Autonomy Measurement System (SMAF)|29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability|Baseline, one week, and one month following surgery|||units on a scale||Standard Deviation|Mean
45187|NCT01382225|Secondary|Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating|"The subject was asked on a questionnaire, Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life, and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement."|Baseline, Up to Day 14|Modified Intent-to-Treat||Percentage of Participants|||Number
45188|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score|For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percentage change||Standard Deviation|Mean
45189|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score|The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percent change||Standard Deviation|Mean
45190|NCT01382225|Secondary|Percentage Change From Baseline in Schirmer I Score|The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percent change||Standard Deviation|Mean
45191|NCT01382225|Secondary|Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score|The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat||Percent change||Standard Deviation|Mean
45192|NCT01382225|Secondary|Change From Baseline in GSF Total Score at Day 14|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat||Units on a scale||Standard Deviation|Mean
45193|NCT01382225|Secondary|Change From Baseline in LGS Total Score at Day 14|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat||Units on a scale||Standard Deviation|Mean
45194|NCT01382225|Primary|Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat||Units on a scale||Standard Deviation|Mean
45195|NCT01382225|Primary|Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat (mITT): The set of all randomized subjects who received at least one administration of the allocated product, had baseline efficacy measurement, had at least 1 post-baseline measurement and received the correct formulation of the lissamine green solution.||Units on a scale||Standard Deviation|Mean
45196|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Physical Examination Findings||Baseline (Day 1) and Final Visit (up to Week 12)|All-treated data set||participants|||Number
45197|NCT01382212|Secondary|Oral Body Temperature: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||degrees Celsius||Standard Deviation|Mean
45198|NCT01382212|Secondary|Heart Rate: Mean Change From Baseline to Final Visit|Heart rate was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||bpm||Standard Deviation|Mean
45199|NCT01382212|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit|Blood pressure was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||mm Hg||Standard Deviation|Mean
45200|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings|12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.|Baseline (Day 1) to Final Visit (up to Week 12)|All-treated data set||participants|||Number
45201|NCT01382212|Secondary|Number of Subjects With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).|All-treated data set||participants|||Number
45202|NCT01382212|Secondary|Osteocalcin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||ng/mL||Standard Deviation|Mean
45203|NCT01382212|Secondary|Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||pg/mL||Standard Deviation|Mean
45204|NCT01382212|Secondary|Total Protein and Albumin: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set||g/dL||Standard Deviation|Mean
45205|NCT01382212|Secondary|Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||mEq/L||Standard Deviation|Mean
45206|NCT01382212|Secondary|Alkaline Phosphatase: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||IU/L||Standard Deviation|Mean
45207|NCT01382212|Secondary|Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||mg/dL||Standard Deviation|Mean
45208|NCT01382212|Secondary|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||U/L||Standard Deviation|Mean
45209|NCT01382212|Secondary|Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||cells x 10^9/µL||Standard Deviation|Mean
45210|NCT01382212|Secondary|White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||cells x 10^3/µL||Standard Deviation|Mean
45211|NCT01382212|Secondary|Red Blood Cells: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||cells x 10^6/µL||Standard Deviation|Mean
45212|NCT01382212|Secondary|Hematocrit: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||percent||Standard Deviation|Mean
45213|NCT01382212|Secondary|Hemoglobin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data||g/dL||Standard Deviation|Mean
45214|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set||percentage of participants||95% Confidence Interval|Number
45215|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set||percentage of participants||95% Confidence Interval|Number
45216|NCT01382212|Primary|Percentage of Subjects With Hypercalcemia|The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).|Day 1 to Week 12|All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol||percentage of participants||95% Confidence Interval|Number
45217|NCT01382186|Primary|Veteran Need for Education Support for My HealtheVet and Secure Messaging Use.|Veterans were asked to report if they would like to have education and support using My HealtheVet and the Secure Messaging tool.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
45218|NCT01382186|Primary|Veterans That Believed Improvements to the Secure Messaging System Would Make the Tool More Useful in the Future Are Presented in the Table.|Veterans were asked to report if improvements to the secure messaging system would make the tool more useful for use in the future.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
45219|NCT01382186|Primary|Intention to Use Secure Messaging in the Future|Veteran respondent intention to use Secure Messaging in the future|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
45220|NCT01382186|Primary|Benefits of Using Secure Messaging|Veterans report benefits of using Secure Messaging|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
45221|NCT01382186|Primary|Reasons for Using Secure Messaging Tool on My HealtheVet|Participants reported reasons for Using Secure Messaging tool on My HealtheVet|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.||participant|||Number
45222|NCT01382186|Primary|Frequency of Electronic Resource Use|Mail surveys examine Veterans frequency of electronic resource use.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans. The purposive sample of 33 Veterans from phase 1 was not included in this method of the study.||participants|||Number
45223|NCT01382186|Primary|Secure Messaging Use and Content Patterns|Extraction of secure messages over a three-month time frame to examine message content type, including: general, tests, medication, and appointments.|3 months|This method of secondary data collection was conducted with the purposive sample of 33 Veterans in phase 1 of the study. The random sample of 819 Veteran survey respondents in phase 2 were not included in this method of data collection.||secure messages|Participants||Number
45224|NCT01382186|Primary|Usability of Secure Messaging|To determine ease of use and usefulness of secure messaging. Purposive sample of 33 participants were assessed for their ability to complete the following tasks: navigate to Secure Messaging, log-in to My HealtheVet and Secure Messaging, Set user preferences, check Secure Message inbox, open and send Secure Message, Open and read Secure Message attachment. Measured as: (1) able to complete task; (2) able to complete task with some difficulty; (3) not able to complete task.|baseline|This user-testing method was conducted with the first purposive sample of 33 participants in phase 1 of the study. The random sample of 819 participants in phase 2 were not a part of the user-testing study method.||participants|||Number
45225|NCT01382108|Primary|Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.|Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.|||mm||Standard Deviation|Mean
45226|NCT01382108|Primary|Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.|Measurements will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.|||seconds||Standard Deviation|Mean
45227|NCT01382108|Primary|Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6)|"Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.~The meibomium gland dropout score subjective grading scale:~0 = no loss of mebomium glands~= area of meibomium gland loss less than 33%~= area of meibomium gland loss between 33% and 67%~= area of meibomium gland loss more than 67%."|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.|||units on a scale||Standard Deviation|Mean
45228|NCT01381952|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)||percentage of dose reduction||Standard Deviation|Mean
45229|NCT01381952|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)||percentage of dose reduction||Standard Deviation|Mean
45230|NCT01381952|Primary|Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.|"The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics.~A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA."|1 day|||Scores on a scale||95% Confidence Interval|Mean
45231|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18|The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Percentage of patients|||Number
45296|NCT01380730|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
45232|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Percentage of patients|||Number
45233|NCT01381900|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Pecent change||Standard Error|Least Squares Mean
45234|NCT01381900|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
45235|NCT01381900|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of double-blind study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
45236|NCT01381679|Secondary|Change From Baseline in TG at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.||mg/dL||95% Confidence Interval|Mean
45237|NCT01381679|Secondary|Change From Baseline in Triglycerides (TG) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.||mg/dL||95% Confidence Interval|Mean
45238|NCT01381679|Secondary|Change From Baseline in HDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.||mg/dL||95% Confidence Interval|Mean
45239|NCT01381679|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.||mg/dL||95% Confidence Interval|Mean
45240|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.||mg/dL||95% Confidence Interval|Mean
45241|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.||mg/dL||95% Confidence Interval|Mean
45242|NCT01381679|Secondary|Change From Baseline in TC at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.||mg/dL||95% Confidence Interval|Mean
45243|NCT01381679|Secondary|Change From Baseline in Total Cholesterol (TC) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.||mg/dL||95% Confidence Interval|Mean
45244|NCT01381679|Primary|Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level|Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively|Up to 12 months|||Participants|||Number
45245|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])|Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
45246|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])|Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
45247|NCT01381575|Secondary|Number of Subjects Completing the Vaccination Course|The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.|Up to Month 13|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
45297|NCT01380639|Secondary|Brain Natruretic Peptide (BNP)|change in BNP from baseline to day 19|day 1, day 19||||||
45298|NCT01380639|Secondary|Arterial Blood Gas||day 1||||||
45299|NCT01380639|Secondary|Lung Function||day 1||||||
45300|NCT01380639|Secondary|BODE-Score|Change in Bode-Score from baseline to day 19|day 1, day 19||||||
45248|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response|"The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.~For this group, results were only made available one month after the last vaccine dose, at Month 13."|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million B-cells||Inter-Quartile Range|Median
45249|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T-cells||Inter-Quartile Range|Median
45250|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination and B-cell pre-vaccination status.||cells/million B-cells||Inter-Quartile Range|Median
45251|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million B-cells||Inter-Quartile Range|Median
45252|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)|The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 7 EL.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T-cells||Inter-Quartile Range|Median
45253|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)|The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T cells||Inter-Quartile Range|Median
45254|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)|"The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells.~All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titer lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titer ≥ 7 EL.U/mL) prior to vaccination."|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T cells||Inter-Quartile Range|Median
45301|NCT01380639|Secondary|Isometric Maximum Handgrip Force|change in isometric max. handgrip force from baseline to day 19|day 1, day 19||||||
45302|NCT01380639|Secondary|Body Composition|Change in body composition from baseline to day 19|day 1 and 19||||||
45255|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)|"The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells.~All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination."|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||cells/million T cells||Inter-Quartile Range|Median
45256|NCT01381575|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination."|From Day 0 up to Months 7, 13, 18, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
45257|NCT01381575|Secondary|Number of Subjects With Pregnancies Ongoing and Their Outcome|Specific pregnancy outcomes were elective termination with apparent congenital anomaly and ectopic pregnancy.|From Day 0 up to Months 7, 13, 24 and 36|The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
45258|NCT01381575|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Months 7, 13, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
45259|NCT01381575|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|"pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Note: Results up to Months 24 and 36 will be updated once they become available."|From Day 0 up to Months 7, 13, 18, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
45260|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = Unsolicited AE preventing normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the study vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.||Subjects|||Number
45261|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = Occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Fever > 39.0 °C. Related = General symptom assessed by the investigator as causally related to the vaccination.|During the 7-day period (Days 0-6) following any vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.||Subjects|||Number
45262|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-16 and ≥ 7 EL.U/mL for HPV-18.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
45263|NCT01381575|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = Significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = Redness/swelling above 50 millimeters (mm).|During the 7-day period (Days 0-6) following any vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.||Subjects|||Number
45303|NCT01380639|Primary|6-Minute-Walking-Distance|Change in 6-minute-walking-distance from baseline to day 19|day 1, day 19|||m||Standard Deviation|Mean
52890|NCT01287416|Secondary|Suicidal Ideation in Past 2 Days at Baseline|Number of people who endorsed having thought about suicide in the past 2 days as measured at baseline (not at all vs a little to a lot)|July 19-20, 2010|||participants|||Number
45264|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
45265|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-016 and ≥ 7 EL.U/mL for HPV-018|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
45266|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
45267|NCT01381575|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were and expressed as geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay [ELISA] units per millilitre (EL.U/mL), with the cut-off values of 8 EL.U/mL for HPV-016 and 7 EL.U/mL for HPV-018.|1 month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
45268|NCT01381575|Primary|Number of Subjects Seroconverted for Anti- Human Papilloma Virus 16 (Anti-HPV-16) and Anti-Human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|1 month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
45269|NCT01381471|Primary|Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period|The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)||healthcare encounters||Standard Deviation|Mean
45270|NCT01381471|Primary|Mean Number of Pharmacy Claims by Participants During the Post-Index Period|The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)||pharmacy claims||Standard Deviation|Mean
45271|NCT01381406|Secondary|Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years|Unadjusted incidence rates per 100 person years of chronic obstructive pulmonary disease (COPD)-related hospitalizations and emergency department visits by treatment group are presented. Incidence rate is calculated by dividing the number of healthcare service encounters by the number of person years of follow up. Person years adjust for different lengths of follow up for individual participants|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.||visits per 100 person years|||Number
45272|NCT01381406|Secondary|Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group|The mean costs of health care encounters adjusted to control for baseline differences between treatment groups and reported in 2008 United States dollars as calculated with the consumer price index (CPI) are presented. CPI is standard multiplier for adjusting the cost of goods and services to a single year. Total costs include pharmacy and medical costs. Medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. COPD-related pharmacy costs were computed from paid amounts of COPD-related prescription medications.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.||United States dollars||95% Confidence Interval|Mean
45348|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45273|NCT01381406|Primary|Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)|A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.||exacerbations per 100 person years|||Number
45274|NCT01381120|Secondary|Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.|Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and three months.|||units on a scale||95% Confidence Interval|Mean
45275|NCT01381120|Primary|Change in Post-ureteroscopy Stent-induced Pain|Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and 3 months.|||units on a scale||95% Confidence Interval|Mean
45276|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude||Post estradiol at one month|||IU/L||Standard Error|Mean
45277|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude|The study is powered on luteinizing hormone pulse amplitude because it is the clinical outcome for which the most data is available. The primary comparison is whether there is a significant reduction in the pulse amplitude in the obese between the pre- and post-treatment periods and whether there is no change in the pulse amplitude in the normal weight patients between the pre and post-treatment periods.|Baseline|||IU/L||Standard Error|Mean
45278|NCT01380834|Secondary|Opioid Consumption|Other secondary end points will total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used at 24 hours postoperatively (or until the patient is discharged, if sooner).|24 hrs after blocks were done or until the patient is discharged|||mg/kg||Standard Deviation|Mean
45279|NCT01380834|Secondary|Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).|The VAS (Visual Analog Scale, 0 mm “no pain”, to 100 mm,” the worst pain possible “) is used to assess postoperative pain for patients. Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block.|24 hrs after blocks were done or until the patient is discharged|||units on a scale||Standard Deviation|Mean
45280|NCT01380834|Primary|Opioids Consumption Via PCA|The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.|12 hrs after the blocks were done|||ng/kg/min||Standard Deviation|Mean
45281|NCT01380782|Other Pre-specified|Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI|To explore the correlation between perfusion MRI, diffusion MRI and response to therapy.|2 years||||||
45282|NCT01380782|Other Pre-specified|Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells|To explore the correlation between serum angiogenic peptides, circulating endothelial cells, and circulating progenitor cells with response to therapy.|2 years||||||
45283|NCT01380782|Other Pre-specified|Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile|To explore the extent to which the tumor's genotype and expression profile correlate with outcome.|2 years||||||
45284|NCT01380782|Other Pre-specified|Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG)|To explore the efficacy of BIBF 1120 in bevacizumab-naïve and bevacizumab-treated participants with recurrent anaplastic gliomas (AG) survival was assessed at 6 months for Arm A and 3 months for Arm B.|Arm A - 6 months; Arm B - 3 months|||percentage of participants|||Number
45285|NCT01380782|Secondary|Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial)|Safety profile in both populations - as adverse events are posted separately in detail, these results will demonstrate serious adverse events (defined as grades 3-5) that were judged at least possibly related to Nintedanib (BIBF 1120).|2 years|||number of incidents|||Number
45286|NCT01380782|Secondary|Time-to-tumor Progression|Time-to-tumor progression in both populations.|2 years|||days||95% Confidence Interval|Median
45287|NCT01380782|Secondary|Overall Survival|Overall survival in both populations|2 years|||months||95% Confidence Interval|Median
45288|NCT01380782|Secondary|Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response|Best radiographic response in both populations. There were no participants with partial or complete responses, so the results are being reported in the proportion of participants who experienced stable disease (SD) as their best response (as opposed to progressive disease).|2 years|||% of patients with best response SD|||Number
45289|NCT01380782|Primary|3-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-treated participants with recurrent GBM as measured by 3-month progression free survival (PFS3).|3 months|||percentage of participants|||Number
45290|NCT01380782|Primary|6-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).|Six months|||percentage of participants|||Number
45304|NCT01380379|Secondary|Change in Assertiveness Between Baseline and Post-intervention|"Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior.~The positive change indicates an increase in assertive behavior."|Change in assertiveness from baseline to post-class (8 weeks)|||units on a scale||Standard Deviation|Mean
45305|NCT01380379|Primary|Change in Self-efficacy From Baseline to Post-treatment|General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence.|Change in GSE from baseline to 8 weeks|The data is the change in general self efficacy from baseline to post-class, with higher scores indicating a greater increase in self-efficacy||units on a scale||Standard Deviation|Mean
45306|NCT01380366|Secondary|To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.|Following completion of Visit 2, study staff will obtain results of liver injury/function tests (ALT, Aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALK or ALP), GGT) from the medical record from each routine clinical exam from Month 3 through Month 24. Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.|(Visit 1) Baseline, (Visit 2) 28-31 days after baseline, then at regularly scheduled follow-up clinic visits for two years from Month 3 through Month 24|||participants|||Number
45307|NCT01380366|Primary|To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).|Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.|(Visit 1) Baseline to (Visit 2) 28-31 days after baseline|||participants|||Number
45308|NCT01380327|Secondary|Percent of Participants With the Occurrence of Adverse Events (AEs)|Percent of participants who experienced at least one AE.|Participant enrollment to end of study (up to 3 months post-baseline)|||Percentage of population|||Number
45309|NCT01380327|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity Over Time|Outcome is change in mean IgE FAB activity level from baseline to post-baseline (status post 3 months of treatment). Serum from cockroach sublingual immunotherapy (SLIT)-treated participants were analyzed to determine if treatment inhibits in-vitro cockroach SLIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.(Reference: Shamji MH et al. The IgE-facilitated allergen binding (FAB) assay: validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods 2006;317(1-2): 71-9).|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Percent antibody binding||95% Confidence Interval|Mean
45310|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin subclass 4 (IgG4). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Ratio||95% Confidence Interval|Geometric Mean
45311|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin G (IgG). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Ratio||95% Confidence Interval|Geometric Mean
45312|NCT01380327|Primary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.||Ratio||95% Confidence Interval|Geometric Mean
45313|NCT01379183|Secondary|Small Intestine and Colon Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
45314|NCT01379183|Secondary|Small Intestine Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
45315|NCT01379183|Secondary|Colonic Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
45316|NCT01379183|Secondary|Ileal Volume|The Ileal is the terminal portion of the small intestine extending from the jejunum to the cecum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
45317|NCT01379183|Secondary|Jejunal Volume|The jejunum is the section of the small intestine between the duodenum and the ileum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
45318|NCT01379183|Primary|Gastric Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds.|Approximately 60 minutes after beginning ingestion of fluid volume|||mL||Standard Error|Mean
45319|NCT01380197|Secondary|Pain Relief||2 days|||participants|||Number
45320|NCT01380197|Primary|Acute Chest Syndrome|A new pulmonry infiltrate on Chest X-ray|3 days|||participants|||Number
45321|NCT01380145|Secondary|Assessment of Survival and Time to Subsequent Therapy|Progression-free survival (PFS) was calculated as the date from first immunization to first observation of disease progression or death due to any cause, censored on the start date of subsequent therapy or at the last date of disease assessment for subjects without a PFS event. Overall survival (OS) was calculated as the date from first immunization to death due to any cause, censored at the date of last follow-up for subjects who were alive at the time of the analysis. Time to subsequent therapy was calculated as the date from first immunization to start of subsequent therapy for myeloma, censored at the date of death or last follow-up for subjects who did not receive subsequent therapy.|Continuously on study and for up to 5 years post-study|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.||days||Full Range|Median
45322|NCT01380145|Secondary|Assessment of Tumor Response|"Tumor responses were evaluated using appropriate imaging methods and were categorized according to the IMWG criteria, which includes the following response designations:~Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% plasma cells in bone marrow; Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow; Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component <100 mg/24 hrs; Partial Response (PR): ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to <200 mg/24 hrs Stable disease: not response or progression"|At 3 and 12 months after auto-SCT|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.||participants|||Number
45323|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Cellular Immunity|Cellular immunity was determined by enzyme-linked immunosorbent spot assay (ELISPOT) or intracellular flow cytometry to determine peripheral blood levels of interferon gamma-producing CD4+ and CD8+ T cells specific for MAGE-A3. Results were considered significant if > 50 spots and > 2 times the number of spots to negative control were observed.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.||participants|||Number
45324|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Humoral Immunity|Humoral immunity was determined by enzyme-linked immunosorbent assay (ELISA) to measure the presence of circulating antibodies to MAGE-A3. Titers against an antigen were considered significant if they were >100. Induction of responses was considered significant if there was a change from undetectable (<100) to detectable (>100) or if there was an at least 4-fold increase in titers over time.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.||participants|||Number
45325|NCT01380145|Primary|Assessment of Safety of recMAGE-A3 + AS15|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs, with severity graded according to the NCI CTCAE, Version 4.0.|Continuously for up to 14 months|The Safety Analysis Set comprises all subjects who received at least 1 immunization with study drug.||participants|||Number
45326|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45327|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45328|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45329|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45330|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
46349|NCT01368536|Secondary|Percentage of Patients Achieving Blood Pressure Control After Treatment|Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg.|12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
45331|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45332|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45333|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||pg/mL||Standard Deviation|Mean
45334|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs||Standard Deviation|Mean
45335|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45336|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45337|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45338|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45339|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45340|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45341|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45342|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||pg/mL||Standard Deviation|Mean
45343|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs||Standard Deviation|Mean
45344|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45345|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45346|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45347|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45349|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45350|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs*pg/mL||Standard Deviation|Mean
45351|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
45352|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.||hrs||Standard Deviation|Mean
45353|NCT01380093|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45354|NCT01380093|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45355|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45356|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45357|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45358|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45359|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45490|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||Log10 copies per ml||Standard Deviation|Mean
45360|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45361|NCT01380093|Secondary|Take Drug Again Effect at 24 Hours|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”).|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45362|NCT01380093|Secondary|Overall Drug Liking Effect at 24 Hours|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm= “neither like nor dislike”, and 100 mm= “strong liking”).|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45363|NCT01380093|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45364|NCT01380093|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45365|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45366|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45367|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45368|NCT01380093|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45369|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45370|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45491|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|9 months|Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).||Log10 copies per ml||Standard Deviation|Mean
45371|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45372|NCT01380093|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45373|NCT01380093|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45374|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45375|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45376|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45377|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45378|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45379|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45380|NCT01380093|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45381|NCT01380093|Secondary|Feel Sick: Peak Effect (Emax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45382|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45383|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45384|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45385|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45386|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45387|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45388|NCT01380093|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45389|NCT01380093|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45390|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-24 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45391|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-12 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45392|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-8 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45393|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-4 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45492|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|6 months|||Log10 copies per ml||Standard Deviation|Mean
45394|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-2 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45395|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45396|NCT01380093|Secondary|Bad Effects: Time to Maximum (Peak) Effect (TEmax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45397|NCT01380093|Secondary|Bad Effects: Peak Effect (Emax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45398|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45399|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45400|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45401|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45402|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45403|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45404|NCT01380093|Secondary|Any Effects: Time to Maximum (Peak) Effect (TEmax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45439|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 That is at Least a One-grade Increase From Baseline for the Following Targeted Laboratory Values by Week 48|"Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48~The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST"|From study entry to week 48||12/2020||||
45405|NCT01380093|Secondary|Any Effects: Peak Effect (Emax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45406|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45407|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45408|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45409|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45410|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45411|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45412|NCT01380093|Secondary|Good Effects: Time to Maximum (Peak) Effect (TEmax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45413|NCT01380093|Secondary|Good Effects: Peak Effect (Emax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45414|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45415|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45440|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48|Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48|From study entry to week 48||12/2020||||
45416|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45417|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45418|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45419|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45420|NCT01380093|Secondary|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45421|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-24 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45422|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-12 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45423|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-8 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45424|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-4 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45425|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-1 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45426|NCT01380093|Secondary|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs||Standard Deviation|Mean
45441|NCT01380080|Secondary|Proportion of Participants With TB Diagnosis Per Current ACTG Diagnosis Appendix by Week 96|Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96|From study entry to week 96||12/2020||||
45427|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45428|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45429|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45430|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45431|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45432|NCT01380093|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45433|NCT01380093|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). Emax = Maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.||mm||Standard Deviation|Mean
45434|NCT01380093|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2)."|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose pharmacodynamic (PD) data from each period and did not have major protocol violations.||hrs*mm||Standard Deviation|Mean
45435|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48|Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48|From study entry to week 48||12/2020||||
45436|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48|Proportion of participants with premature discontinuation of any component of TB treatment by Week 48|From study entry to week 48||12/2020||||
45437|NCT01380080|Secondary|Proportion of Participants With Reportable Hospitalization by Week 48|Proportion of participants with any hospitalization reported by Week 48|From study entry to week 48||12/2020||||
45438|NCT01380080|Secondary|Proportion of Participants With IRIS (Using Current ACTG Definition) by Week 48|Proportion of participants with IRIS (using current ACTG definition Appendix 60) by Week 48|From study entry to week 48||12/2020||||
45442|NCT01380080|Secondary|Time to Initiation of TB Treatment by Week 96|Median time to TB treatment initiation by week 96|From study entry to week 96||12/2020||||
45443|NCT01380080|Secondary|CD4+ T-cell Count Change From Baseline|Change was calculated as the CD4+ T-cell count at week (4 and 24) minus the baseline CD4+ T-cell count. The results at week 48 will be submitted after the study is completed|From study entry to weeks 4, 24 and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||cells/ mm^3||Inter-Quartile Range|Median
45444|NCT01380080|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm^3) at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: Participants were analyzed per original assigned randomized treatment. Missing data were assigned missing completely at random.||cells/ mm^3||Inter-Quartile Range|Median
45445|NCT01380080|Secondary|Proportion of Participants With HIV-1 RNA Level <400 Copies/mL|Proportion of participants with HIV-1 RNA level <400 copies/mL at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completed at random||Proportion of participants||95% Confidence Interval|Number
45446|NCT01380080|Secondary|Cumulative Probability of Death or AIDS Progression by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24~The result of cumulative probability of death or AIDS progression by week 48 will be submitted after the study is completed. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment||Cumulative probablity per 100 persons||95% Confidence Interval|Number
45447|NCT01380080|Secondary|Cumulative Probability of First AIDS Progression by Week 96|The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition|From study entry to week 96||12/2020||||
45448|NCT01380080|Secondary|Cumulative Probability of Death by Week 24|The Kaplan-Meier estimate of cumulative probability of death by week 24|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment||Cumulative probablity per 100 persons||95% Confidence Interval|Number
45449|NCT01380080|Primary|Cumulative Probability of Death or Unknown Vital Status by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24.~Vital status at week 48 and again at weeks 60, 72, 84, and 96 was determined for participants who do not complete study follow-up, including those who are prematurely discontinued from the study before week 24 without coming in to the clinic. Vital status for participants who are not discontinued from the study whenever a scheduled visit of any type is missed was also obtained. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment||Cumulative probablity per 100 persons||95% Confidence Interval|Number
45450|NCT01379963|Secondary|Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL|Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.||Percentage of participants|||Number
45451|NCT01379963|Primary|Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)|Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.||Percentage of participants|||Number
45452|NCT01379937|Secondary|Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies|This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
45453|NCT01379937|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies||At Days 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
45454|NCT01379937|Secondary|Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364."|At Days 0, 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
45455|NCT01379937|Secondary|Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease|Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
45456|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364.~This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol."|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
45457|NCT01379937|Secondary|Mean Geometric Increase for Anti-H5N1 Antibody Titers|"MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
45458|NCT01379937|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.~Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192."|At Days 0,42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
45459|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease|"A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
45460|NCT01379937|Secondary|Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364."|At Days 0, 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Subjects|||Number
45461|NCT01379937|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
45462|NCT01379937|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)||During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
45463|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During Day 0 to Telephone Contact (TC) Day 84 overall.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
45464|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 21-day (Days 0 – 20) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
45465|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature[defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more.|During a 7-day (Day 0-6) follow-up period after vaccination|The analysis was based on subjects aged 6 years or more, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
45466|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on subjects aged less than 6 years, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
45467|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
45468|NCT01379937|Secondary|H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
45469|NCT01379937|Secondary|H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
45470|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade.|From Day 0 to Day 364.|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.||Subjects|||Number
45471|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|From Day 0 to Day 182|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.||Subjects|||Number
45472|NCT01379937|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Day 192.|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.||Titer||95% Confidence Interval|Geometric Mean
45473|NCT01379781|Primary|Hamilton Rating Scales of Depression|"Assessing severity of depression; clinician rated~24 questions~13 items are scored on a 5 point scale ranging from 0=not present to 4=severe~11 items are scored from 0-2~A composite score is created by the sum of the scores from all items. Scores can range from 0-74~0-7: normal~8-13: mild depression~14-18: moderate depression~19-23: severe depression~24: very severe depression~Higher summed values indicate a greater severity of depression"|6 weeks postpartum|Those in the analysis received both baseline and 6-week assessment sessions.||units on a scale||Standard Deviation|Mean
45489|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||Log10 copies per ml||Standard Deviation|Mean
45474|NCT01379768|Primary|Change From Week 1 in Relative Oxidative Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
45475|NCT01379768|Primary|Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
45476|NCT01379768|Primary|Change From Week 1 in Leukocyte Population at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.||Leukocytes||Standard Deviation|Mean
45477|NCT01379768|Primary|Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).|Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
45478|NCT01379768|Primary|Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.|Week 5|This reporting group includes all participants who completed the study per protocol.||Ratio||Standard Deviation|Mean
45479|NCT01379768|Primary|Leukocyte Population|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.|Week 5|This reporting group includes all participants who completed the study per protocol.||Leukocytes||Standard Deviation|Mean
45480|NCT01379703|Secondary|Adverse Events Observed on Treatment With Lopinavir/Ritonavir.|"Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.~All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the Reported Adverse Events section of this record."|18 months|||Events|||Number
45481|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed any doses of their antiretroviral treatment.|18 months|Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.||Participants|||Number
45482|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed doses of their antiretroviral treatment.|9 months|||Participants|||Number
45483|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||Participants|||Number
45484|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|9 months|||Participants|||Number
45485|NCT01379703|Primary|Laboratory Parameter Lipids|A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||millimoles per liter||Standard Deviation|Mean
45486|NCT01379703|Primary|Laboratory Parameter Transaminases|Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.||international units per liter||Standard Deviation|Mean
45487|NCT01379703|Primary|Laboratory Parameter Blood Glucose|Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed after 9 months.||millimoles per liter||Standard Deviation|Mean
45488|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on last observation carried forward (N=660).||Log10 copies per ml||Standard Deviation|Mean
45493|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|3 months|||Log10 copies per ml||Standard Deviation|Mean
45495|NCT01379703|Primary|Viral Load|Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.|Baseline|Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.||Log10 copies per ml||Standard Deviation|Mean
45496|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 18 months.||cells per mm³||Standard Deviation|Mean
45497|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 15 months.||cells per mm³||Standard Deviation|Mean
45498|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 12 months.||cells per mm³||Standard Deviation|Mean
45499|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 9 months|Change from baseline analysis is based on participants with CD4 count results available at 9 months.||cells per mm³||Standard Deviation|Mean
45500|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 6 months|Change from baseline analysis is based on participants with CD4 count results available at 6 months.||cells per mm³||Standard Deviation|Mean
45501|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 3 months|Change from baseline analysis is based on participants with CD4 count results available at 3 months.||cells per mm³||Standard Deviation|Mean
45502|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 1 month|Change from baseline analysis is based on participants with CD4 count results available at 1 month.||cells per mm³||Standard Deviation|Mean
45503|NCT01379703|Primary|CD4 Count|CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.|Baseline|Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.||cells per mm³||Standard Deviation|Mean
45504|NCT01379651|Secondary|Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP|Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.|Baseline and 6 months|We were unable to calculate sample size because no quantitative data about the clinical outcome could be hypothesized. Indeed, the few reports of food causing allergy, the protocol, the way of SOTI administration and food doses administered yielded reported variable results. the analysis was per intention to treat||mm diameter||Full Range|Median
45505|NCT01379651|Primary|Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg|To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.|baseline and 6 months|||participants|||Number
45506|NCT01379534|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|up to 30 days after the last dose of study drug, up to 18 weeks|Safety analysis set: The safety set included all participants who received at least one dose of study medication.||Participants|||Number
45507|NCT01379534|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Months||95% Confidence Interval|Median
45508|NCT01379534|Secondary|Overall Survival (OS)|OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.|up to 18 weeks|Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.||Months||95% Confidence Interval|Median
45627|NCT01377636|Other Pre-specified|Number of Participants With Significant Change in Heart Rate|Heart rate measured by standard EKG monitor during anesthesia. Pre- and Post Heart rates where noted. An increase of 8 percent or more was defined as a significant change in heart rate.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
45509|NCT01379534|Secondary|Duration of Response (DR)|Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.|up to 18 weeks|This outcome measure was not analyzed. The analysis was not required because there were too few responders.|||||
45510|NCT01379534|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Percentage of participants|||Number
45511|NCT01379534|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Percentage of participants|||Number
45512|NCT01379534|Primary|Progression Free Survival (PFS) Rate|The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as “failure”. Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.||Percentage of participants|||Number
45513|NCT01378988|Primary|Number of Subjects Who Received Rescue Medication for Sedation and Analgesic|Participants who received rescue medication midazolam for sedation and/or fentanyl for analgesic during study drug Infusion|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate pharmacokinetic samples to estimate primary parameters.||participants|||Number
45514|NCT01378988|Primary|Absolute Time That Subject is in UMSS Range 2-4 During Treatment Period|"The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS).~Score 0 (awake/alert); Score 1 (sleepy/responds appropriately); Score 2 (somnolent/arouses to light stimuli); Score 3 (deep sleep/arouses to deeper physical stimuli); Score 4 (unarousable).~The UMSS scores obtained just prior the loading dose (LD) and 5 and 10 minutes during LD; 0, 5, 10, 15, 30, and 60 minutes and thereafter every 4 hours of the maintenance infusion; within 5 minutes of obtaining each pharmacokinetic sample; within 5 minutes prior and after any midazolam rescue during dexmedetomidine infusion period."|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Hours||Standard Deviation|Mean
45515|NCT01378988|Primary|Average Total Faces, Legs, Activity, Cry, and Consolability (FLACC) Score|FLACC scale is a 5 category observational measure to assess pediatric pain on face, legs, activity, cry and consolability. Responses in each category are scored between 0 to 2 (0 = normal, relaxed to 2 = upset, rigid), for a maximum total score of 10.|Prior to loading dose and every hour during the maintenance infusion; within 5 minutes after any fentanyl administration during DEX infusion or every 4 hours in case of continuous fentanyl infusion; within 5 minutes prior and after titration of fentanyl|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||units on a scale||Standard Deviation|Mean
45516|NCT01378988|Primary|Weight-Adjusted Volume of Distribution (Vdw)|Weight-Adjusted Volume of distribution of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre per Kilogram||Standard Deviation|Mean
45517|NCT01378988|Primary|Volume of Distribution (Vd)|Volume of distribution of dexmedetomidine after intravenous administration. Volume of distribution measures how much the drug spreads through the body after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre||Standard Deviation|Mean
45518|NCT01378988|Primary|Plasma Clearance (CL)|Clearance of dexmedetomidine after intravenous administration. Clearance is the rate at which the drug is removed from the plasma after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre per Hour||Standard Deviation|Mean
45519|NCT01378988|Primary|Weight-Adjusted Plasma Clearance (CLw)|Weight-Adjusted Plasma Clearance of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Litre per Hours per Kilogram||Standard Deviation|Mean
45520|NCT01378988|Primary|Time to Reach Maximum Plasma Concentration (Tmax)|Observed time to reach maximum plasma concentration of dexmedetomidine, expressed in hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Hours||Standard Deviation|Mean
45521|NCT01378988|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life of dexmedetomidine. Half-life is the time required for plasma concentration of the drug to decrease by 50%.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||Hours||Standard Deviation|Mean
45522|NCT01378988|Primary|Steady State Concentration (Css)|Concentration of dexmedetomidine at steady state in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||picogram per millilitre||Standard Deviation|Mean
45523|NCT01378988|Primary|Observed Peak Plasma Concentration (Cmax)|Maximum observed concentration of dexmedetomidine in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||picogram per millilitre||Standard Deviation|Mean
45524|NCT01378988|Primary|Area Under the Plasma Concentration-time Curve (AUC0-∞)|Area under the plasma concentration-time curve of dexmedetomidine at 0 to Infinity hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.||picogram*hour per millilitre||Standard Deviation|Mean
45525|NCT01378975|Secondary|Percentage of Participants With Adverse Events (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|From signing of informed consent form up to 28 days after the last dose of study drug (approximately up to 4 years)|The safety population included all participants who received at least one dose of study medication.||percentage of participants|||Number
45526|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Not Necessarily Follows the RECIST Criteria - as Assessed by Investigator)|Percentage of participants who were responders (with best overall response (BOR) documented as confirmed complete response [CR] or partial response [PR]) were reported.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
45527|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Assessed by Investigator)|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, ‘n’ indicates the number participants who were evaluable for within brain assessment and who had measurable disease outside brain at baseline for outside brain assessment.||percentage of participants|||Number
45528|NCT01378975|Secondary|Overall Survival|Overall survival was defined as time between enrollment on Day 1 and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the latest date they were known to be alive prior to or on the cutoff date.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||months||Full Range|Median
45529|NCT01378975|Secondary|Time to Development of New Brain Metastases in Responders|Time to development of new lesions within the brain was defined as the interval between the date of first treatment and the earliest date of documentation of new brain lesions. Participants who were known to be free of new lesions were censored on the date of last tumor assessment.|Date of first treatment and the earliest date of documentation of new brain lesions (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, number of participants analyzed is the participants who were responders.||months||Full Range|Median
45530|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Tumor Assessment Within Brain Only (Assessed by Investigator )|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||months||Full Range|Median
45531|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Overall Tumor Response (Assessed by Investigator)|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within or outside the brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||months||Full Range|Median
45628|NCT01377636|Secondary|Number of Participants Who Follow Verbal Command to Squeeze Hands|"Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Ability to follow verbal commands before and after isoproterenol infusion was assessed by asking subjects to squeeze my hands."|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
45532|NCT01378975|Secondary|Duration of Response (DOR) (Assessed by Investigator and IRC)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the earliest date of PD or death from any cause. For participants who were alive without progression following the qualifying response, DOR were censored on the date of last available tumor assessment on or before the data cutoff date.|Date of the earliest qualifying response until the earliest date of PD or death from any cause (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, 'n' indicates number of participants who were responders within brain or outside brain assessed by investigator or IRC.||months||Full Range|Median
45533|NCT01378975|Secondary|Best Overall Response Rate Outside the Brain (Assessed by IRC)|BORR outside of brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, number participants analyzed is the total number of participants who had measurable disease outside brain at baseline.||percentage of participants||95% Confidence Interval|Number
45534|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated Brain Metastases as Assessed by the IRC Using RECIST v1.1|BORR within brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
45535|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated or Untreated Brain Metastases as Assessed by the IRC Using RECIST v1.1|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.||percentage of participants|||Number
45536|NCT01378975|Primary|Best Overall Response Rate (BORR) Within Brain of Previously Untreated Participants (Assessed by Independent Review Committee [IRC] Using Modified Response Evaluation Criteria in Solid Tumors [RECIST])|BORR assessed by IRC is defined as percentage of participants who were responders [with best overall response (BOR) documented as confirmed complete response (CR) or partial response (PR)]. The RECIST v1.1 criteria modified for independent review of body and brain lesions was based on current radiology practices. The modifications to RECIST v1.1 included allowing target lesions in the brain to be >=5 mm by contrast-enhanced magnetic resonance imaging scan (in traditional RECIST v1.1 this is >=10 mm), allowing up to 5 target lesions in the brain (in traditional RECIST v1.1 only 2 target lesions), and examining the lesions within the brain and outside the brain separately for analytical purposes. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm), PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The intent to treat (ITT) population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
45537|NCT01378962|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).|Baseline, At progression of disease (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had samples for EGFR mutation. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.||percentage of participants|||Number
45538|NCT01378962|Secondary|Percentage of Participants With Primary and Secondary Resistance|Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline up to disease progression (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had a documented PD response during the study period.||percentage of participants|||Number
45754|NCT01375777|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
45539|NCT01378962|Secondary|Percentage of Participants Achieving CR, PR, or SD as Best Overall Response|The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.||percentage of participants||95% Confidence Interval|Number
45540|NCT01378962|Primary|Probability of Being Progression Free 12 Months After Baseline|According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|ITT population.||probability of being progression-free||Standard Error|Mean
45541|NCT01378962|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.|Up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.||months||90% Confidence Interval|Median
45542|NCT01378962|Secondary|Percentage of Participants With Objective Response|Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.||percentage of participants||95% Confidence Interval|Number
45543|NCT01378962|Secondary|Percentage of Participants With a Response by Best Overall Response|Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.||percentage of participants|||Number
45544|NCT01378962|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.|Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.||months||Standard Error|Mean
45545|NCT01378962|Secondary|Percentage of Participants Who Died||Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.||percentage of participants|||Number
45546|NCT01378962|Primary|Percentage of Participants With Disease Progression or Death at 12 Months After Baseline|According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|Intent to treat (ITT) population included all participants enrolled in the study who received at least 1 dose of treatment.||percentage of participants|||Number
45547|NCT01378520|Secondary|Change in Level of B-endorphin Immunoreactivity|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L|At the end of resistance load breathing (4.5 hours after receiving the test article)|||pmol/L||Standard Deviation|Mean
45548|NCT01378520|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
46350|NCT01368536|Secondary|Percentage of Responders After Treatment|Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
45549|NCT01378520|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for unpleasantness through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.~Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|||units on a scale||Standard Deviation|Mean
45550|NCT01378429|Secondary|Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||units on a scale||Standard Deviation|Mean
45551|NCT01378429|Secondary|Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of devices|Participants||Number
45552|NCT01378429|Secondary|Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||Devices|Participants||Number
45553|NCT01378429|Secondary|Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of number of correct advances||Standard Deviation|Mean
45554|NCT01378429|Secondary|Apparent Volume of Distribution (Vz/F)|Vz/F Liters (L) is the apparent volume of distribution|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||L||Standard Deviation|Mean
45555|NCT01378429|Secondary|Apparent Clearance of the Drug (CL/F)|CL/F liter per hour (L/hour) is the apparent clearance of the drug|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||L/hour||Standard Deviation|Mean
45556|NCT01378429|Secondary|Terminal Half Life (t1/2)|Terminal half-life (t1/2) (hour)|Weeks 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||Hour||Standard Deviation|Mean
45557|NCT01378429|Secondary|Time to the Occurrence of Cmax|tmax (hour) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||Hour||Standard Deviation|Mean
45558|NCT01378429|Secondary|Maximum Observed Concentration|Cmax (ng/mL) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
45559|NCT01378429|Secondary|AUC(0-24h)|Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing.|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.||ng*hr/mL||Standard Deviation|Mean
45560|NCT01378429|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of participants|||Number
45561|NCT01378429|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||participants|||Number
45562|NCT01378429|Secondary|Percentage of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||percentage of participants|||Number
45563|NCT01378429|Secondary|Number of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.||participants|||Number
45564|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine||weeks 0-6|The PP population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no IPDs.||mcg/g||Standard Error|Least Squares Mean
45565|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine||weeks 0-6|The PP population. Subjects with either missing baseline data or post dose data, or both were not included in the analysis||mcg/g||Standard Error|Least Squares Mean
45566|NCT01378429|Primary|The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period|Area under the concentration-time curve from time 0 to 24 hours [AUC(0-24h)]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.|Week 0 and 6|The Per Protocol (PP) population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no important protocol deviations (IPDs).||mcg•hour/dL||Standard Error|Least Squares Mean
45567|NCT01378416|Primary|AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, day 3|||ng∙hr/mL||Standard Deviation|Mean
45568|NCT01378416|Primary|Tmax (Time at Which Cmax First Observed)|3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3|||hours||Standard Deviation|Mean
45569|NCT01378416|Primary|Cmax (Maximum Plasma Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3|||ng/mL||Standard Deviation|Mean
45570|NCT01378416|Primary|Average Total Body Clearance (Calculated From Rate and Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3|||L/hr/m^2|||Number
45571|NCT01378416|Secondary|Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)|Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients|6 weeks|||Participants|||Number
45572|NCT01378325|Primary|Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.|"Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:~stopping the phenylephrine infusion~changing the rate of phenylephrine infusion~rescue intravenous bolus of phenylephrine (100 µg) for hypotension~rescue intravenous bolus of atropine (0.4 mg) for bradycardia"|Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).|||number of interventions||Full Range|Median
45573|NCT01378221|Primary|Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients||change from baseline within 1 month after cardiac surgery|||percentage||Standard Error|Mean
45574|NCT01378195|Secondary|Perceived Quality of Life|"The Perceived Quality of Life (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome."|3 months|||units on a scale||Standard Deviation|Mean
45575|NCT01378195|Secondary|Revised Memory and Behavior Problems Checklist|"This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this bothered or upset them. A conditional bother score is calculated which is the upset or bother ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome."|3 months|||units on a scale||Standard Deviation|Mean
45576|NCT01378195|Primary|Perceived Stress Scale|"The Perceived Stress Scale measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome."|3 months|||units on a scale||Standard Deviation|Mean
45577|NCT01378117|Secondary|Hospital Mortality|Hospital mortality. Mortality is defined as death occurring during admission|during hospitalization, average 5 days||||||
45578|NCT01378117|Secondary|Acute Renal Failure|Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (serum creatinine > 2.2 mg/dL or an increment > 0.5 mg/dL from baseline).|during hospitalization, average 5 days||||||
45579|NCT01378117|Secondary|Composite Cardiac Complications|Cardiac complications are defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, congestive heart failure, or cardiac arrest.|during hospitalization, average 5 days||||||
45580|NCT01378117|Secondary|ICU Need|Need for ICU care (transfer to ICU)|during hospitalization, average 5 days||||||
45581|NCT01378117|Secondary|Total Daily Dose of Insulin||during hospitalization, average 5 days||||||
45582|NCT01378117|Secondary|Hyperglycemia|Number of episodes of hyperglycemia (BG > 300 mg/dl) after the first day of treatment.|during hospitalization, average 5 days||||||
45583|NCT01378117|Secondary|Severe Hypoglycemia|severe hypoglycemic events (<40 mg/dl).|during hospitalization, average 5 days||||||
45584|NCT01378117|Secondary|Hypoglycemia|Number of hypoglycemic events (<70 mg/dl)|during hospitalization, average 5 days||||||
45585|NCT01378117|Primary|Glucose Levels|The primary outcome of the study is to determine differences in glycemic control as measured by mean daily BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2DM.|during hospitalization, average 5 days|||mg/dl||Standard Deviation|Mean
45586|NCT01378104|Secondary|IL28B Polymorphism Effect on SVR|We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.|post treatment 24 weeks|The patients who agreed to check the genotype were analysed.||percentage of SVR|||Number
45587|NCT01378104|Primary|Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a|We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.|post treatment 24 weeks|We present the result of intention-to-treat analysis.||participants who achieved SVR|||Number
45588|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 12 months|All subjects||units on a scale||Standard Deviation|Mean
45589|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 months|All subjects||units on a scale||Standard Deviation|Mean
45590|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 3 months|All subjects||units on a scale||Standard Deviation|Mean
45591|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 weeks|All subjects||units on a scale||Standard Deviation|Mean
45592|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 12 months|The 25 subjects who completed the PISQ-12 at the twelve month follow up visit.||units on a scale||Standard Deviation|Mean
45593|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 months|The 26 subjects who completed the PISQ-12 at the six month follow up visit.||units on a scale||Standard Deviation|Mean
45594|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 3 months|The 25 subjects who completed the PISQ-12 at the three month follow up visit.||units on a scale||Standard Deviation|Mean
45595|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 weeks|The 28 subjects who completed the PISQ-12 at the six week follow up visit.||units on a scale||Standard Deviation|Mean
45596|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months|Bladder function is measured by UDI-6 Questionnaire at 12 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 12 months|All subjects.||units on a scale||Standard Deviation|Mean
45597|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months|Bladder function is measured by UDI-6 Questionnaire at 6 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 months|All subjects.||units on a scale||Standard Deviation|Mean
46378|NCT01368211|Primary|Change in Maximum Amplitude at 1-hour Post-transfusion|Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion|pre-transfusion, 1-hour post transfusion|||mm||Standard Deviation|Mean
45598|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months|Bladder function is measured by UDI-6 Questionnaire at 3 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 3 months|All subjects.||units on a scale||Standard Deviation|Mean
45599|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks|Bladder function is measured by UDI-6 Questionnaire at 6 weeks. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 weeks|All subjects.||units on a scale||Standard Deviation|Mean
45600|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.|"The PGI-I Index consists on one question and was collected at 12 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|12 months|All subjects||participants|||Number
45601|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.|"The PGI-I Index consists on one question and was collected at 6 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 months|The 29 subjects who completed the PGI-I at the six month follow up visit.||participants|||Number
45602|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.|"The PGI-I Index consists on one question and was collected at 3 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|3 months|The 29 subjects who completed the PGI-I at the three month follow up visit.||participants|||Number
45603|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.|"The PGI-I Index consists on one question and was collected at 6 weeks. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 weeks|The 29 subjects who completed the PGI-I at the six week follow up visit.||participants|||Number
45604|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 month|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.||percentage of subjects|||Number
45605|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 month|The 5 subjects who were treated in the posterior compartment with Restorelle Direct Fix and have POP-Q measurement recorded at the six month follow-up visit.||percentage of subjects|||Number
45606|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 month|The six subjects who had posterior compartment vaginal reconstruction surgery.||percentage of subjects|||Number
45607|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 week|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.||percentage of subjects|||Number
45608|NCT01378065|Secondary|Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.|"Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months. Per the protocol, mesh extrusion is defined as passage gradually out of a body structure or tissue. Mesh exposure is defined as  a condition of displaying, revealing, exhibiting or making accessible e.g. vaginal mesh visualized through separated vaginal epithelium."|12 months|All study subjects.||percentage of subjects|||Number
45609|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|12 months|All subjects||participants|||Number
45610|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 months|All subjects||participants|||Number
45613|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
45614|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
45615|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
45616|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks|Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 weeks|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.||percentage of subjects|||Number
45617|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 12 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|12 months|The 11 sexually active subjects without dyspareunia at baseline. At the 12 month follow-up visit, only 11 subjects were sexually active and thus only 11 subjects completed Question 3.5 on the PISQ-12 questionnaire. Therefore, the number of participants analyzed for this outcome was 11 at the 12 month follow-up visit.||percentage of subjects|||Number
45618|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at six months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 months|The 12 sexually active subjects without dyspareunia at baseline.||percentage of subjects|||Number
45619|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 3 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|3 months|The 12 sexually active subjects without dyspareunia at baseline.||percentage of subjects|||Number
45620|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 weeks|The 12 sexually active subjects without dyspareunia at baseline.||percentage of subjects|||Number
45621|NCT01378065|Primary|Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|Baseline|All subjects||participants|||Number
45622|NCT01377636|Primary|BIS Change|The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.The difference between Pre-BIS and Post-BIS was calculated.|Within 20 minutes of starting isoproterenol infusion|||units on a scale||95% Confidence Interval|Mean
45623|NCT01377636|Other Pre-specified|Number of Participants Who Developed Ischemia or ST Segment Changes|The (ST) segment on the EKG was monitored for changes suggestive of demand ischemia. An observable EKG change compared to baseline was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
45624|NCT01377636|Other Pre-specified|Number of Participants With New Arrhythmia During Steady State.|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation after return to sinus rhythm. If a non-sinus arrhythmia resulted from the infusion, the arrhythmia was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of start of isoproterenol|||participants|||Number
45625|NCT01377636|Other Pre-specified|Number of Participants With Amnesia or No Recall During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Specific pre-determined test words were spoken to the subject during administration of isoproterenol. After anesthesia, patients were tested for possible recall of those specific words. If no words were recalled, the result was categorically defined as amnesia.|Within one hour of completing anesthesia|||participants|||Number
45626|NCT01377636|Other Pre-specified|Number of Participants With Change in Blood Pressure|Non-Invasive Blood Pressure (NIBP) is measured routinely as part of an anesthetic. Pre- and Post Blood Pressures where noted. An increase or decrease of 10 percent or more was defined as a significant change in systolic blood pressure.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
45629|NCT01377636|Secondary|Number of Participants With Spontaneous Musculoskeletal Movement|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Patients under steady state total venous anesthesia (TIVA) with propofol and remifentanil infusions with BIS around 50 normally do not move even in the absence of neuromuscular blockade. Spontaneous movement appearing like restlessness during sleep is unusual. Several patients under anesthesia after isoproterenol appear to wake up and move spontaneously.|Within 20 minutes of starting isoproterenol infusion|||participants|||Number
45630|NCT01377636|Primary|Number of Participants With an Increase in BIS Readings During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. BIS levels were measured continuously before and after isoproterenol administration. Number of participants with increase in BIS reading during anesthetic steady state are reported below. The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.|During time of Electrophysiology (EP) studies.|||participants|||Number
45631|NCT01377623|Secondary|Concentration of IL-8||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
45632|NCT01377623|Secondary|Concentration of IL-6||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
45633|NCT01377623|Secondary|Concentration of IL-1a||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
45634|NCT01377623|Secondary|Concentration of TNF-alpha||Post-operative Day 1|||pg/ml||Inter-Quartile Range|Median
45635|NCT01377623|Primary|Quality of Recovery Score (QoR-40)|The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).|Post-operative Day 3|||units on a scale||Standard Deviation|Mean
45636|NCT01377480|Primary|Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction|Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.|Day 180|The Full Analysis Population included all randomized subjects who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
45637|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45638|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45639|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45640|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45641|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45642|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45643|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45644|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.||Percent change||95% Confidence Interval|Median
45645|NCT01377467|Other Pre-specified|1,25-(OH)2 Vitamin D3|Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||ng/L||95% Confidence Interval|Least Squares Mean
45646|NCT01377467|Other Pre-specified|25-OH-vitamin D3|Blood levels of 25-OH-vitamin D3 were measured as microgramm/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||microgramm/L||95% Confidence Interval|Least Squares Mean
45647|NCT01377467|Other Pre-specified|Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12|Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12|baseline and months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||ng/L||95% Confidence Interval|Least Squares Mean
45648|NCT01377467|Other Pre-specified|Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||mmol/L||95% Confidence Interval|Least Squares Mean
45649|NCT01377467|Other Pre-specified|Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, thus all randomised patients with valid data at all time points were included.||mmol/L||95% Confidence Interval|Least Squares Mean
45650|NCT01377467|Secondary|P1NP at Baseline and Months 3, 6 and 12|Blood concentrations of P1NP were measured in microgram/L|baseline, month 3, month 6, and month 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||microgram/L||95% Confidence Interval|Least Squares Mean
45651|NCT01377467|Secondary|Beta-CTX at Baseline and Months 3, 6 and 12|Blood concentrations of beta-CTX (microgram/L)|baseline, month 3, month 6, and month 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.||microgram/L||95% Confidence Interval|Least Squares Mean
45652|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 6|The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
45653|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 6|The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
45654|NCT01377467|Secondary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6|The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.|Baseline and month 6|The intention-to-treat was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
45655|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 12|The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
45656|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 12|The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
45657|NCT01377467|Primary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12|The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the primary efficacy analysis, i.e. all subjects were included that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).||percent change||Standard Deviation|Mean
45658|NCT01377441|Secondary|Quality of Recovery Score (QoR-40).|The secondary outcome parameters will be the quality of recovery score (QoR-40) to measure quality of recovery from surgery, a simple fatigue scale, digits forward and backward, and the global depression schedule. Forty questions in five dimensions will be scored by patients on a five-point Likert scale. Seven point fatigue scales (in- and out-patient) is often used to assess progress of recovery in head trauma patients. Metrics will be administered on at the baseline visit and or on the day of surgery and on postoperative days 1, 2, 4 and 6.|48h||||||
45659|NCT01377441|Primary|Concentrations of the Cytokines Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin IL-1Beta (IL-1Beta), IL-2, IL-6, IL-10, and Interferon-gamma (IFN-gamma) as Well as Prostaglandin E2 at Different Time Points.|Concentration of the cytokines TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, and IFN-gamma as well as prostaglandin E2 at different time points will be our primary outcome. Changes in mediator levels in the IV ibuprofen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), at the end of the surgery, and on the first postoperative day.|48h|Unfortunately, due to major flooding at our site, due to Hurricane Sandy, all data and samples for this study were lost. Therefore, it was impossible to analyze any data for this study.|||||
45660|NCT01377402|Secondary|Cardiac Events During Follow-up.|Cardiovascular death.. Myocardial infarctions (re-MIs) defined according to WHO criteria of 1979.|2-5 years||||||
45661|NCT01377402|Primary|Total Mortality.|Mortality for any reason|2-5 years|Patients with suspected ACS||participants|||Number
45662|NCT01377233|Secondary|Clinical Global Impression Improvement Scale (CGI-I)|The CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)||units on a scale||Standard Deviation|Mean
45737|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||µm||Standard Deviation|Mean
45663|NCT01377233|Secondary|Clinical Global Impression Severity Scale (CGI-S) Change From Baseline|The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)||units on a scale||Standard Error|Mean
45664|NCT01377233|Secondary|Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the analysis.||units on a scale||Standard Error|Mean
45665|NCT01377233|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)|11 weeks for open-label period; 13 weeks for double-blind period|Adverse events for the 46 patients enrolled in the open-label period are reported in the first (open-label) study arm. Adverse events for the 42 patients (out of the 46 enrolled) who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.||participants|||Number
45666|NCT01377194|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.||units on a scale||Standard Error|Least Squares Mean
45667|NCT01377194|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.|The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.||Units on a scale||Standard Deviation|Mean
45668|NCT01376908|Secondary|Population PK Parameter: Time to Maximum Plasma Concentration (Tmax)||Up to Week 26|Tmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/F and interindividual variability could not be estimated for Ka.|||||
45669|NCT01376908|Secondary|Population PK Parameter: Maximum Observed Plasma Concentration (Cmax)||Up to Week 26|Cmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/f and interindividual variability could not be estimated for absorption rate constant (Ka).|||||
45670|NCT01376908|Secondary|Population PK Parameter: Terminal Elimination Half-life (t1/2)|The t1/2 was defined as the time required for plasma concentration of drug to decrease 50 percent (%) in the final stage of elimination. Since t1/2 could not be obtained from non-compartmental analysis because of sparse data, t1/2 was estimated as Log(2)*(V/F)/(CL/F), where V/F & CL/F were the population apparent central Volume & clearance, estimated from population PK model. The reason for pooling subjects receiving Kuvan & subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.||hours|||Number
45671|NCT01376908|Secondary|Population PK Parameter: Area Under the Plasma Concentration Curve, Time 0 to Infinity (AUC [0-infinity])|AUC [0-infinity] was estimated by determining total area under the curve of the concentration versus time curve extrapolated to infinity. Since AUC could not be obtained from non-compartmental analysis because of sparse data, AUC = Dose/(CL/F); CL/F was population apparent clearance estimated from the population PK model, & Dose the actual total dose received by the patient on one dosing interval. The reason for pooling subjects receiving Kuvan &subjects with Phe-restricted Diet was to facilitate estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led to biased estimated of Kuvan PK parameters. This pooling assumes that the the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 were same for the 2 arms and cannot be presented per arm/per treatment group as per planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.||microgram*hour per liter(mcg*hour/liter)||Standard Deviation|Mean
45672|NCT01376908|Secondary|Population PK Parameter: Apparent Volume of Distribution (V/f)|V/f is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.||liter||Standard Error|Mean
45673|NCT01376908|Secondary|Population Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/f)|CL/f is the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways.The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.||liter per hour||Standard Error|Mean
45674|NCT01376908|Secondary|Number of Samples With Phenylalanine Hydroxylase (PAH) Gene Mutations|The DNA samples received were quantified by using a nanophotometer, and were aliquoted to a concentration of 20 nanogram/microliter DNA and aliquots from each sample were distributed to one 96-well plate. All samples were Sanger sequenced regarding exons 1 to 13 of the PAH gene in forward direction using the DNAs in the 96-well plate. All samples showing variants were Sanger sequenced regarding the concerned exon in reverse direction using DNA from the original tube. All samples showing a homozygous mutation were analyzed by MLPA. All samples showing only 1 mutation were analyzed by MLPA. All samples showing only 1 or no mutation were resequenced completely (exons 1 to 13) in both directions.|Screening (within 42 days prior to Day 1 of the 26-week study period)|Analysis population included subjects who signed pharmacogenetics (PGx) informed consent and whose samples were available for analysis. Out of 109 subjects screened for the study, 77 PGx informed consent forms were signed and 73 samples were analyzed.||Sample|||Number
45675|NCT01376908|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."||mmHg||Standard Deviation|Mean
45676|NCT01376908|Secondary|Dietary Phe Tolerance During Extension Period|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Every 6 months during 3 year extension period or until product is commercially approved|The extension period of this study is ongoing. Data will be provided after completion of extension period i.e first quarter 2017|||||
45677|NCT01376908|Secondary|Number of Subjects With Hypophenylalanemia|Hypophenylalanemia is defined as the condition of blood Phe levels <120 mcmol/L.|Week 26|Safety population consisted of all subjects who had some safety assessment data available (at least one visit in vital signs, AE or laboratory results) in the Study Period and who received at least one dose of Kuvan in the Study Period, or who were randomized to Phe-restricted diet alone.||Subjects|||Number
45678|NCT01376908|Secondary|Growth Parameters Standard Deviation Scores (SDS)|Growth assessment was performed by monitoring body mass index, height (or length), weight, and maximal occipital-frontal head circumference (MOFHC). Supine length was measured up to 2 years of age thereafter standing height was measured unless subject was unable to stand upright, in which case supine length was measured. Respective parameter SDS was calculated as the value of parameter minus reference mean value of parameter divided by standard deviation of the reference population.|Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."||SDS||Standard Deviation|Mean
45679|NCT01376908|Secondary|Neurodevelopmental Status Assessed Using Bayley III Scales of Infant and Toddler Development|Neurodevelopmental assessments was done using the following age-dependent scales: Bayley III for subjects less than (<) 3.5 years of age and WPPSI III for subjects greater than or equal to (>=) 3.5 to <4 years of age, based on following scores: adaptive behavior composite (ABC) score, cognitive composite (CC) score, language composite (LC) score, motor composite (MC) score., and social-emotional composite (SEC) score. Composite scores ranged from 40 (very poor) to 160 (excellent) and are classified as following: >=115: accelerated performance; 85-114: development within normal limits; 70-84: mildly delayed development; less than or equal to (<=) 69: significant delayed development.|Baseline and Week 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."||Units on a scale||Standard Deviation|Mean
45738|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||µm||Standard Deviation|Mean
46379|NCT01368185|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 3.|Baseline and Month 3|||mmHg||Standard Deviation|Mean
46380|NCT01368185|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 3.|Baseline and Month 3|||mmHg||Standard Deviation|Mean
45680|NCT01376908|Secondary|Number of Subjects With Normal Neuromotor Developmental Milestones Assessed Using Denver Developmental Scale (DDS)|"Subjects with normal neuromotor development were assessed by standardized developmental milestones using a parent/guardian report form in the following areas: fine motor, gross motor, language, and personal-social using DDS Test. DDS Test is a widely used to examine the developmental progress of 0-6 years of children. It is a test for screening cognitive & behavioral problems and to assess subjects at risk for developmental problems. The scale reflects what percentage of a certain age group is able to perform a certain task. Tasks are grouped into 4 categories (social contact, fine motor skill, language, and gross motor skill) and include items such as smiles spontaneously, knocks 2 building blocks against each other, speaks 3 words other than mom and dad, or hops on 1 leg. For a newborn, testing can detect neurologic problems. For an infant, testing often serves to reassure parents or to identify the nature of problems early enough hopefu"|Baseline, Weeks 12, 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."||subjects|||Number
45681|NCT01376908|Secondary|Number of Subjects With Any TEAEs, AEs Related to Kuvan, Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study treatment and up to 31 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 31 days after the last dose of study drug administration|Safety population included all subjects who either received at least one dose of Kuvan in the study period, or were randomized to Phe-restricted diet alone and who had some safety assessment data available.||subjects|||Number
45682|NCT01376908|Secondary|Change From Baseline in Dietary Phe Tolerance After 26 Weeks|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Baseline and at Week 26 (last observation carried-forward [LOCF])|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.||mg/kg/day||Standard Error|Mean
45683|NCT01376908|Secondary|Mean Blood Phe Levels|Mean blood phe levels were defined as the mean of blood phe levels assessed over each 2-week intervals|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.||micromol per liter (mmol/L)||Standard Deviation|Mean
45684|NCT01376908|Primary|Dietary Phenylalanine (Phe) Tolerance at Week 26|Phe tolerance was defined as the amount of dietary Phe prescribed (milligram per kilogram per day [mg/kg/day]) while maintaining blood Phe levels within the selected therapeutic target range (defined as greater than or equal to [>=] 120 to less than [<] 360 micromoles per liter [mcmol/L]).|Week 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated.||mg/kg/day||Standard Error|Mean
45685|NCT01376804|Secondary|Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)|All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.|52 Weeks|All patients meeting the resistance analysis criteria are included into the resistance analysis.||Participants|||Number
45686|NCT01376804|Secondary|Number of Participants With Death||52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
45687|NCT01376804|Secondary|Number of Participants With Graft Loss|Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
45688|NCT01376804|Secondary|Number of Participants With Biopsy Proven Rejection|Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
45689|NCT01376804|Secondary|Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant|Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above.|52 weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
45690|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
45691|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.||Participants|||Number
45692|NCT01376804|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs|"An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs.~A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant."|52 weeks|Safety Population included all enrolled patients who received at least one dose of study medication and had at least one post-baseline assessment of safety.||Participants|||Number
45693|NCT01376700|Post-Hoc|Number of Inhibitors in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) - (Only ‘True’ Inhibitors)|"PUPs = no previous FVIII exposure; MTPs ≤4 previous FVIII exposures~’True’ positive inhibitor (PI) = any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, per study protocol) assessed as either:~i. High FVIII inhibitor titer (>5 BU/mL)~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as ‘true’ positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:~a) Lower or absent therapeutic response at infusion of standard replacement doses (“clinically relevant”) as deemed by clinician in charge.~b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.~Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:~> 5 BU/mL, categorized as high-titer inhibitor~≥0.6 BU/mL but ≤5 BU/mL, categorized as low-titer"|50 exposure days to ADVATE|Safety Analysis Set||inhibitors|||Number
45694|NCT01376700|Post-Hoc|Number of Participants With Factor VIII (FVIII) Inhibitors by Inhibitor Type (Only ‘True’ Inhibitors)|"’True’ positive inhibitor (PI) defined as any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, in accordance with study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL)~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as ‘true’ positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:~a) Lower or absent therapeutic response at infusion of standard replacement doses (“clinically relevant”) as deemed by the clinician in charge.~b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.~Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:~> 5 BU/mL, then categorized as a high-titer inhibitor~≥0.6 BU/mL but ≤5 BU/mL, then categorized as a low-titer."|50 exposure days to ADVATE|Safety Analysis Set||participants|||Number
45695|NCT01376700|Secondary|Number of Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) at Least Possibly Related to ADVATE|Possibly or probably related adverse events|50 exposure days to ADVATE|Safety Analysis Set||adverse events|||Number
45696|NCT01376700|Secondary|FVIII-Specific Antibody Isotype for All Participants at Study Entry and Every 10 Exposure Days (EDs)||50 exposure days to ADVATE|Summary statistics of FVIII-Specific Antibody Isotypes were not performed due to the early termination of the study|||||
45697|NCT01376700|Secondary|Total Factor VIII (FVIII) Consumption by Participant||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess the total FVIII consumption by participant|||||
45698|NCT01376700|Secondary|Correlation of Known Risk Factors to Factor VIII (FVIII) Inhibitor Formation||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess associations between known risk factors to inhibitor formation.|||||
45699|NCT01376700|Secondary|Number and Type of Surgeries|"Elective surgery is not allowed during period of first 20 exposure days (EDs)~Peripherally inserted central catheter (PICC)"|50 exposure days to ADVATE|Safety Analysis Set||surgeries|||Number
45700|NCT01376700|Secondary|Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)|"Nominal Dosing Frequency:~1 time per week~2 times per week~Unknown dosing frequency (UK)~Bleeding Type (BT):~Skin~Muscle and Soft Tissue~Mucosal~Joint~Other~Multiple~Total~Bleeding severity:~Minor~Moderate~Severe~Total"|50 exposure days to ADVATE|Safety Analysis Set||Bleeds|Participants||Number
45701|NCT01376700|Secondary|Number of Participants With Low-titer, High-titer, Transient, and All Factor VIII (FVIII) Inhibitors|"High FVIII inhibitor titer (> 5 Bethesda Unit (BU)/mL)~Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)"|50 exposure days to ADVATE|Safety Analysis Set||participants|||Number
45702|NCT01376700|Secondary|Number of Exposure Days of Treatment With Advate Prior to First Positive Factor VIII (FVIII) Confirmed Inhibitor Assessment|"Confirmed inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 BU/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set||days||Inter-Quartile Range|Median
45703|NCT01376700|Secondary|Number of Participants With Severe Hemophilia A (FVIII ≤ 1%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.~Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set||participants|||Number
45739|NCT01376362|Primary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||µm||Standard Deviation|Mean
45704|NCT01376700|Primary|Number of Participants With Severe and Moderately Severe Hemophilia A (FVIII ≤ 2%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.~Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|"Safety Analysis Set~All study participants had severe Hemophilia A, less than 1% Factor VIII levels. (ie there were no moderately severe hemophilia A participants (FVIII levels >1% to ≤ 2%) in this study."||participants|||Number
45705|NCT01376557|Secondary|Change From Baseline in Triglycerides at Week 12||12 weeks|ITT||mg/dL||Standard Deviation|Mean
45706|NCT01376557|Secondary|Change From Baseline in Systolic Blood Pressure (SPB) at Week 12||12 weeks|ITT||mm Hg||Standard Deviation|Mean
45707|NCT01376557|Secondary|Change From Baseline in Body Weight at Week 12||12 weeks|ITT||kg||Standard Deviation|Mean
45708|NCT01376557|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12||12 weeks|ITT||mg/dL||Standard Deviation|Mean
45709|NCT01376557|Secondary|Number of Participants Achieving a HbA1c Value of <7% at Week 12||12 weeks|ITT||participants|||Number
45710|NCT01376557|Primary|Change From Baseline in HbA1c to Week 12||12 weeks|ITT||% change||Standard Deviation|Mean
45711|NCT01376388|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD visits were conducted for participants who completed the Week 24 visit or withdrew before Week 24 and completed the Week 52 visit or withdrew before Week 52, respectively. The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|Baseline (Screening visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."||Participants|||Number
45712|NCT01376388|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population."||Beats per minute||Standard Deviation|Mean
45713|NCT01376388|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population."||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
45714|NCT01376388|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||Millimoles/Liter (MMOL/L)||Standard Deviation|Mean
45751|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45752|NCT01375777|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45753|NCT01375777|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
45715|NCT01376388|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measuremnt of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||Micromoles/Liter (µM/L)||Standard Deviation|Mean
45716|NCT01376388|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||International Units/Liter (IU/L)||Standard Deviation|Mean
45717|NCT01376388|Secondary|Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."||Proportion||Standard Deviation|Mean
45718|NCT01376388|Secondary|Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)|Blood samples were collected for the measurement of hemoglobin, albumin, and total protein at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."||Grams/Liter (G/L)||Standard Deviation|Mean
45719|NCT01376388|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurment of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X'' in the category title.||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
45720|NCT01376388|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X in the category title."||Percentage of cells in blood||Standard Deviation|Mean
45721|NCT01376388|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|52 weeks|ITT Population||Participants|||Number
45722|NCT01376388|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of >=5%) and SAEs.|52 weeks|Intent-to-Treat (ITT) Population: all participants who had received at least one dose of study drug||Participants|||Number
45723|NCT01376362|Secondary|Proportion of Participants With a Visual Loss of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in the Study Eye|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks|||Percentage of Participants|||Number
45724|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks|||mm Hg||Standard Deviation|Mean
45725|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks|||mm Hg||Standard Deviation|Mean
45726|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week|||mm Hg||Standard Deviation|Mean
45727|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week|||mm Hg||Standard Deviation|Mean
45728|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks|||ETDRS Letters||Standard Deviation|Mean
45729|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks|||ETDRS Letters||Standard Deviation|Mean
45730|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week|||ETDRS Letters||Standard Deviation|Mean
45731|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week|||ETDRS Letters||Standard Deviation|Mean
45732|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||mm^3||Standard Deviation|Mean
45733|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||mm^3||Standard Deviation|Mean
45734|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||mm^3||Standard Deviation|Mean
45735|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week|||mm^3||Standard Deviation|Mean
45736|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks|||µm||Standard Deviation|Mean
45740|NCT01376297|Primary|Percentage of Patients With Adverse Events|This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.|Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks|Safety Population||percentage of patients with TEAE|||Number
45741|NCT01376245|Secondary|Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168|CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions.|Baseline (BL) and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
45742|NCT01376245|Primary|Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represents those with data available at the time point being presented, however, all par. in the ITT population without missing covariate information with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
45743|NCT01376089|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Overall Image Quality rated as ‘Excellent, Adequate or Poor’ by radiologists blinded to the contrast administration.|Ten minutes post contrast administration.|||Number of subject images|||Number
45744|NCT01376089|Primary|Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration.|||Number of Subjects with discomfort|||Number
45745|NCT01376089|Primary|Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration|||Number of Subjects with discomfort|||Number
45746|NCT01376050|Secondary|Change in Ulcer Size|The study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success.|Baseline and 12 Weeks|||cm²||Standard Deviation|Mean
45747|NCT01376050|Primary|Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups|'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.|Baseline and 12 Weeks|||participants|||Number
45748|NCT01376037|Primary|Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint|Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).|baseline and 2 weeks|||participants|||Number
45749|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45750|NCT01375777|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45755|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45756|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45757|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45758|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45759|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45760|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45761|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45762|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.||percent change||Standard Error|Least Squares Mean
45763|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
45764|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.||mg/dL||Standard Error|Least Squares Mean
45765|NCT01375764|Primary|Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
45766|NCT01375764|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
45767|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B /Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
45768|NCT01375751|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputaton was used.||percent change||Standard Error|Least Squares Mean
45769|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used||percent change||Standard Error|Least Squares Mean
45770|NCT01375751|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
45771|NCT01375751|Secondary|Absolute Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; LOCF imputation was used.||mg/dL||Standard Error|Least Squares Mean
45772|NCT01375751|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C data at Week 12 were imputed using last observation carried forward (LOCF) and calculated LDL-C.||percent change||Standard Error|Least Squares Mean
45773|NCT01375660|Secondary|Incident Diabetes||12 Months|||participants|||Number
45774|NCT01375660|Post-Hoc|Change in Glycemia||12 Months|||percentage of participants|||Number
45788|NCT01375127|Primary|Number of Participants With Central Nervous System (CNS) Infection|Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
45775|NCT01375660|Secondary|C-Peptidogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. C-peptide circulates in blood in amounts equal to insulin because insulin and C-peptide are linked when first made by the pancreas. C-peptide is more stable in blood than insulin; therefore it can be reliably used to evaluate insulin secretion. It is calculated by a special formula using C-peptide and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.~Insulin secretion was assessed based on formula C-Peptidogenic index-30 [(C-Peptide at 30 min – fasting C-peptide)/(glucose at 30 min – fasting glucose)]Bergstrom RW, Wahl PW, Leonetti DL, Fujimoto WY. Association of fasting glucose levels with a delayed secretion of insulin after oral glucose in subjects with glucose intolerance. J Clin Endocrinol Metab. 1990;71:1447-1453.)"|12 Month|||(ng/mL)/(mg/dL)||Standard Deviation|Mean
45776|NCT01375660|Secondary|Insulinogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.~Insulin secretion was assessed based on formula Insulinogenic index-30 [(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952)"|12 Month|||(µU/mL)/(mg/dL)||Standard Deviation|Mean
45777|NCT01375660|Secondary|Insulin Sensitivity by Matsuda Composite|"Insulin Sensitivity by Matsuda Composite – index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS.~Matsuda composite calculated based on formula 10^4/Square Root of [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)]."|12 Months|||10^4/√[(µU/mL)/(mg/dL)x(µU/mL)/(mg/dL)]||Standard Deviation|Mean
45778|NCT01375660|Secondary|Change in HbA1c From Baseline at 12 Months||Baseline and 12 Months|||percentage of A1C||Standard Deviation|Mean
45779|NCT01375660|Primary|Oral Glucose Insulin Sensitivity (OGIS)|"Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test.~The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline."|12 months|||ml/min/m^2 of body surface area||Standard Deviation|Mean
45780|NCT01375569|Secondary|Number of Participants With Adverse Events|here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|25 months, 15 days|||participants|||Number
45781|NCT01375569|Primary|Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).|Time to tumor progression is defined as the proportion of participants who are progression free after 4 months on study. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|2 years|||Weeks||Full Range|Mean
45782|NCT01375374|Secondary|Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||mmol/L||Full Range|Median
45783|NCT01375374|Secondary|Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||pmol/L||Full Range|Median
45784|NCT01375374|Secondary|Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||Free Androgen Index||Full Range|Median
45785|NCT01375374|Primary|Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.||nmol/L||Full Range|Median
45786|NCT01375127|Primary|Number of Participants Who Died||Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
45787|NCT01375127|Primary|Number of Participants With Graft Failure|Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
46381|NCT01368185|Secondary|The Percentage of Patients With Hyperuricemia|Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.|Baseline and Month 3|||percent of participants|||Number
45789|NCT01375127|Primary|Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)|All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.||participants|||Number
45790|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.|Day 28 to Day 196|Sensitivity Analysis Set||percentage of participants||95% Confidence Interval|Number
45791|NCT01375049|Secondary|Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam|The plasma concentration of aztreonam for participants < 6 years of age was obtained 1 hour after the first dose of AZLI on Day 1 and immediately prior to the last dose of AZLI on Day 28.|Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)|Participants in the Full Analysis Set < 6 years of age with evaluable PK profiles were analyzed.||ng/mL||Standard Deviation|Mean
45792|NCT01375049|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline to Days 28, 56, 112, and 196|Full Analysis Set||kg/m^2||Standard Deviation|Mean
45793|NCT01375049|Secondary|Change From Baseline in Height||Baseline to Days 28, 56, 112, and 196|Full Analysis Set||cm||Standard Deviation|Mean
45794|NCT01375049|Secondary|Change From Baseline in Weight||Baseline to Days 28, 56, 112, and 196|Full Analysis Set||kg||Standard Deviation|Mean
45795|NCT01375049|Secondary|Use of Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (an indication of PA exacerbation) while on treatment and posttreatment was summarized.|Baseline to Day 196|Full Analysis Set||percentage of participants|||Number
45796|NCT01375049|Secondary|Percentage of Participants With PA-negative Cultures|The percentage of participants with a PA-negative culture was summarized at each visit.|Days 28, 56, 112, and 196|Participants from the Full Analysis Set who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course were included in the analysis at all time points.||percentage of participants|||Number
45797|NCT01375049|Secondary|Change From Baseline in CFQ-R RSS Score|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) only in participants ≥ 6 years of age. The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.||units on a scale||Standard Deviation|Mean
45798|NCT01375049|Secondary|Change From Baseline in FEV1% Predicted|Spirometry assessments were performed only in participants ≥ 6 years of age. Forced expiratory volume in 1 second (FEV1) % predicted was defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex and body composition.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.||percentage of FEV1% predicted||Standard Deviation|Mean
45799|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.|Day 28 to Day 196|Evaluable Analysis Set||percentage of participants||95% Confidence Interval|Number
45800|NCT01374971|Secondary|Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment|The DAS 28 ESR is a score calculated from the results of a 28-count joint assessment (total number of tender joint possible is 28, and total number of swollen joints possible is 28), the Erythrocyte Sedimentation Rate (ESR), and the Patient Global Assessment (measured using a 100 mm visual analogue scale, with the lowest possible score of 0 mm meaning the subject is not affected at all by arthritis and the highest possible score of 100 mm meaning the subject is severely affected by arthritis). A lower DAS 28 ESR indicates less active disease, and a higher DAS 28 ESR indicates more active disease. The DAS 28 ESR was calculated for each subject at the screening visit and at the Week 14 final visit. The percent change was then calculated for each patient, and a mean percent change for all subjects was determined.|Screening and Week 14|||percent change||Standard Deviation|Mean
45801|NCT01374971|Primary|Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis|Synovial tissue biopsy samples were taken at baseline and at 12 weeks after starting treatment with CZP. These samples were analyzed to determine the concentrations of select biomarkers and to determine the percent change in concentration from baseline to week 12.|Baseline and Week 12|||Percent change||95% Confidence Interval|Geometric Mean
45802|NCT01374919|Secondary|Number of Participants With Treatment Related Serious Adverse Events. Calls for Minor Side Effects Will Occur at 24 and 48 Hours and One Week. A Followup Visit Will Occur at 4 Weeks.||immediate, 24 and 48 hours, one week and followup visit at 4 weeks|||participants|||Number
45803|NCT01374919|Primary|Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.|Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8|baseline 4 weeks and 8 weeks|Two patients had minor infusion reactions and refused rechallenge. All other patients completed the study. Their hemoglobin levels, the primary outcome, were obtained at 4 and 8 weeks.||percentage of participants|||Number
45804|NCT01374802|Secondary|Tmax,ss of Darunavir|time from last dosing to maximum concentration of the analyte in plasma at steady state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set||h||Full Range|Median
45805|NCT01374802|Primary|Cmax,ss of Darunavir|maximum measured concentration of the analyte in plasma at steady-state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
45806|NCT01374802|Primary|Cτ,ss of Darunavir|concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
45807|NCT01374802|Primary|AUCτ,ss of Darunavir|"area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
45808|NCT01374451|Secondary|Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg||Cycle 1 Day 21, Cycle 2 Day 29|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||ng/mL||Standard Deviation|Mean
45809|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Tmax||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||hr||Inter-Quartile Range|Median
45810|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||ng/mL||Standard Deviation|Mean
45811|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for CL/F||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||L/hr||Standard Deviation|Mean
45812|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for AUClast||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.||ng*hr/mL||Standard Deviation|Mean
45813|NCT01374451|Secondary|Disease Control Rate (DCR) as Per Radiology Review|Disease control rate is the percentage of patients with a best overall response of CR or PR or stable disease (SD) determined by the local radiologist according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.0. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). PD: Any progression ≤ 18 weeks after randomization (and not qualifying for CR, PR or stable disease SD.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.||Percentage of participants||95% Confidence Interval|Number
45814|NCT01374451|Secondary|PFS and the Predictive Probability of Success in Phase III|105 PFS events expected after approximately 36 months|Once 105 PFS events had occurred occurred|Since the study was terminated because the study did not meet its primary objective which was based on PFS as per local radiology assessment, minimal efficacy data was obtained. Only 80 PFS events occurred before study was terminated so 105 PFS events was not reached to analyze this data.|||||
45815|NCT01374451|Secondary|Overall Survival (OS) Using Kaplan Meier Method|Overall survival was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was to be censored at the date of last contact.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.||Percentage of participants||95% Confidence Interval|Number
45816|NCT01374451|Secondary|Duration of Response (DoR)|80 PFS are expected after approximately 24 months. Kaplan Meier was initially planned to be used to depict duration of response by treatment group and by stratum. Later based on the mode of action of everolimus and pasireotide and based on study experience, only a low number of objective responses per RECIST were expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients. Only a low number of objective responses per RECIST was expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.|||||
45817|NCT01374451|Secondary|Objective Response Rate (ORR) as Per Radiology Review|"Objective response was determined by the local radiologist according to the RECIST Version 1.0. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). This is also referred to as Overall response rate.~CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline."|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.||Percentage of participants||95% Confidence Interval|Number
45818|NCT01374451|Secondary|Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR|Consisted of monitoring and recording the rate, type, severity, and causal relationship of adverse events (AEs) and serious AEs (SAEs) to treatment. The safety analysis was based mainly on the frequency of AEs or SAEs and on the number of laboratory values that fell outside of pre-determined range.|Once 80 PFS events had occurred|"Safety analysis population included all patients who received any study medication (i.e. at least 1 dose of the study drug in case of monotherapy or at least 1 dose of any 1 compound of the study treatment in case of a combination therapy) with a post-Baseline safety assessment.~See Adverse Events (AE) section for all AEs collected."||Participants|||Number
46382|NCT01368185|Primary|Serum Uric Acid (SUA) Level|SUA at baseline and Month 3.|Baseline and Month 3|||mg/dL||Standard Deviation|Mean
45819|NCT01374451|Primary|Progression-free Survival (PFS) Per Local Radiological Review|PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.|Once 80 PFS events had occurred aproximately after 24 months|"The FAS consisted of all randomized patients. Following the intention to treat principle patients were analyzed according to the treatment (and stratum) they were assigned to at randomization.~One patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems."||months||95% Confidence Interval|Median
45820|NCT01374438|Secondary|Change From Baseline in HMW Adiponectin of MSDC-0160 or Placebo Over 12 Weeks|Estimate the effect of 150 mg daily MSDC-0160 versus placebo on levels of high molecular weight adiponectin. Increases in HMW adiponectin suggest improved insulin sensitivity.|Days 1(baseline) and 91|||micromol/L||Standard Deviation|Mean
45821|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Estimate With the Executive Function Scale|Estimate of the effect of 3-months of MSDC-0160 treatment versus placebo on a 9-item executive function scale. A summary measure of executive function was constructed by converting raw scores from 9 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the executive function tests at both study time points.||z-score||Standard Deviation|Mean
45822|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Determined by the ADAS-Cog Subscale|Alzheimer’s Disease Assessment Scale – Cognitive Subscale, an assessment of cognitive ability. Scores on 11 individual tasks were summed to produce the reported total score, with a possible range of 0 (no impairment) to 70 (severe impairment).|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the ADAS-Cog tests at both study time points.||Scores on a scale||Standard Deviation|Mean
45823|NCT01374438|Secondary|Change From Baseline in Global Cognitive Function Tests|Change from baseline in cognitive function, as determined by global cognitive function on a neuropsychological battery of 19 tests, following 3 months treatment with MSDC-0160 versus placebo. A summary measure of global cognitive function was constructed by converting raw scores from 19 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91|||z-scores||Standard Deviation|Mean
45824|NCT01374438|Primary|Effects of MSDC-0160 on Cerebral Metabolic Glucose Rate or Placebo Over 12 Weeks in Pre-specified Regions of Interest Analysis Referenced to Cerebellum|Investigate the effect of 150 mg daily MSDC-0160 vs placebo on 3-month change in brain glucose utilization using FDG-PET pre-specified regions of interest analysis referenced to cerebellum, including five bilateral regions: posterior cingulate, parietal cortex (angular gyrus), lateral temporal cortex, medial temporal cortex, and anterior cingulate-medial frontal cortex. Results are reported as Standardized Uptake Value Ratios. A change from baseline in the metabolic rate of glucose that is ≥0 indicates maintenance of brain glucose utilization, whereas values <0 indicate a decline in brain glucose utilization.|Days 1(baseline) and 91|Intent-to-treat||Ratio||Standard Deviation|Mean
45825|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45826|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45827|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
46255|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
45828|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45829|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45830|NCT01374425|Secondary|OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45831|NCT01374425|Secondary|OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45832|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45833|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45834|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45835|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45836|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45837|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45838|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45839|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.||percentage of participants||95% Confidence Interval|Number
45840|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.||percentage of participants||95% Confidence Interval|Number
45841|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45842|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
46256|NCT01369784|Primary|Predictive Value of R-IPI at Diagnosis||At diagnosis|||participants|||Number
45843|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45844|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1|Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population||percentage of participants||95% Confidence Interval|Number
45845|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45846|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45847|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||percentage of participants||95% Confidence Interval|Number
45848|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1|Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population||percentage of participants||95% Confidence Interval|Number
45849|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45850|NCT01374425|Secondary|OS in Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45870|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||percentage of participants|||Number
45851|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45852|NCT01374425|Secondary|Overall Survival (OS)|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|ITT Population||months||95% Confidence Interval|Median
45853|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45854|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45855|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45856|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45857|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45871|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||percentage of participants|||Number
46383|NCT01368081|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients||participants|||Number
45858|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45859|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45860|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."||months||95% Confidence Interval|Median
45861|NCT01374425|Primary|Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm). Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|Intent-to-treat (ITT) Population||months||95% Confidence Interval|Median
45862|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||participants|||Number
45863|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||participants|||Number
45864|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|4 weeks|||participants|||Number
45865|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||Days||Standard Deviation|Mean
45866|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||Days||Standard Deviation|Mean
45867|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|4 weeks|||Days||Standard Deviation|Mean
45868|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|6 weeks before starting|||Days||Standard Deviation|Mean
45869|NCT01374269|Secondary|Treatments Associated With Low Back Pain at 6 Months|we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.|6 months|||participants|||Number
46135|NCT01371006|Primary|Group B - Faldaprevir: Cmax,ss|Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
45872|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45873|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45874|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|At the beginning|||units on a scale||Standard Deviation|Mean
45875|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|4 weeks|||units on a scale||Standard Deviation|Mean
45876|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45877|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45878|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|4 weeks|||units on a scale||Standard Deviation|Mean
45879|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|At the beginning|||units on a scale||Standard Deviation|Mean
45880|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45881|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
46190|NCT01370538|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Treatment period is considered to be both weeks 1 and 2 between V3 and V4.|From randomisation to the day 14|Full Analysis Set||Participants|||Number
45882|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|4 weeks|||units on a scale||Standard Deviation|Mean
45883|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|At the beginning|||units on a scale||Standard Deviation|Mean
45884|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45885|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45886|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|4 weeks|||units on a scale||Standard Deviation|Mean
45887|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|At the beginning|||units on a scale||Standard Deviation|Mean
45888|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45889|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
46191|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set||Percentage of heartburn free days||Standard Deviation|Mean
45890|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|4 weeks|||units on a scale||Standard Deviation|Mean
45891|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|At the beginning|||units on a scale||Standard Deviation|Mean
45892|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45893|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45894|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|4 weeks|||units on a scale||Standard Deviation|Mean
45895|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|At the beginning|||units on a scale||Standard Deviation|Mean
45896|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45897|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
46192|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomization to day 14|Per-protocol analysis set||Percentage||Standard Deviation|Mean
45898|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|4 weeks|||units on a scale||Standard Deviation|Mean
45899|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|At the beginning|||units on a scale||Standard Deviation|Mean
45900|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45901|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45902|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|4 weeks|||units on a scale||Standard Deviation|Mean
45903|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|At the beginning|||units on a scale||Standard Deviation|Mean
45904|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45905|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
46411|NCT01367860|Secondary|VAS for Leg Pain - 1st Week|Pain Score for leg pain- Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery|||units on a scale||Standard Deviation|Mean
45906|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|4 weeks|||units on a scale||Standard Deviation|Mean
45907|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|At the beginning|||units on a scale||Standard Deviation|Mean
45908|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45909|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45910|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|4 weeks|||units on a scale||Standard Deviation|Mean
45911|NCT01374269|Primary|Visual Analogue Scale of Pain|The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45912|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45913|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.|4 weeks|||units on a scale||Standard Deviation|Mean
45914|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|At the beginning|||units on a scale||Standard Deviation|Mean
45915|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45916|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45917|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|4 weeks|||units on a scale||Standard Deviation|Mean
45918|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|At the beginning|||units on a scale||Standard Deviation|Mean
45919|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.||units on a scale||Standard Deviation|Mean
45920|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.||units on a scale||Standard Deviation|Mean
45921|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|4 weeks|||units on a scale||Standard Deviation|Mean
45922|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|At the beginning|||units on a scale||Standard Deviation|Mean
45923|NCT01374269|Primary|Visual Analogue Scale of Pain|In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.|At the beginning|||units on a scale||Standard Deviation|Mean
45924|NCT01374178|Secondary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.|Baseline up to 30 days|All randomized participants were included in the analysis.||participants|||Number
45925|NCT01374178|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data.||hour (h)||Full Range|Median
45926|NCT01374178|Secondary|Total Glucose Infused (Gtot)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.||gram (g)||Geometric Coefficient of Variation|Geometric Mean
45927|NCT01374178|Secondary|Maximum Glucose Infusion Rate (Rmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.||grams per hour (g/h)||Geometric Coefficient of Variation|Geometric Mean
45928|NCT01374178|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.||picomole per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
46431|NCT01367665|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)|Note: This is an interim safety analysis, efficacy is not reported at this time.|Until disease progression or unacceptable toxicity (approximately 2 years)||||||
45929|NCT01374178|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)|AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.|Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.||picomole*hour per liter (pmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
45930|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by weight at the time of hospital discharge (approximately 5 weeks)|approximately 5 weeks|||g||Standard Deviation|Mean
45931|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by growth velocity at 28 days of age|28 days of age|||g/d||Standard Deviation|Mean
45932|NCT01373918|Secondary|Mortality Rate|death|at the end of the hospital stay which is expected to be an average of 5 weeks|||participants|||Number
45933|NCT01373918|Primary|Presence of Cholestasis|Cholestasis will be defined by a direct bilirubin > 2 mg/dL|prior to 100 days of life, hospital discharge, or death whichever comes first|||participants|||Number
45934|NCT01373671|Primary|Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone|The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.|1 year|Per protocol 300 subjects were selected for analysis based on 89% power & 5% type one error rate determination.||unitless|breasts|Standard Error|Mean
45935|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR) and hence determine ISR/G.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in placebo n = 18.||ISR (ng/min) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
45936|NCT01373450|Secondary|Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in a placebo n = 18.||mg/dL||Standard Deviation|Least Squares Mean
45937|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment|The reproducibility of insulinotrophic effects was compared after two separate placebo treatment periods within the same treatment sequence. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single subcutaneous dose of placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Over these two treatment periods glucose (G), insulin and C-peptide levels were measured from blood collected at the highest glucose infusion rate; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR), and hence to determine the insulinotrophic effect, ISR/G.|Baseline and 160 minutes after start of GGI at each placebo treatment period|Participants within the same treatment sequence who were treated with Placebo in two separate treatment periods. Participants treated with Oxyntomodulin or Liraglutide were not analyzed for this outcome measure.||ISR (ng/mg) / Glucose (mg/dL)||Standard Deviation|Mean
45938|NCT01373450|Primary|Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM|Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G).|Baseline and up to160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.||ISR (ng/mL) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
45980|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement.|Day 14|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed for each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
45939|NCT01373450|Primary|Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.||mg/dL||Standard Deviation|Least Squares Mean
45940|NCT01373450|Primary|Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)|Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes.|Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.||mg/dL||Standard Deviation|Least Squares Mean
45941|NCT01373346|Secondary|Albumin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of albumin level after operation for the evaluation of long-term safety in good responder group.||g/dl||Standard Deviation|Mean
45942|NCT01373346|Secondary|Hemoglobin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of hemoglobin after operation in good responder group for the evaluation of long-term safety.||g/dl||Standard Deviation|Mean
45943|NCT01373346|Secondary|HbA1c : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of HbA1c after operation in good response group.~HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)~The HbA1c was calculated as a ratio to total hemoglobin."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HbA1c after operation in good responder group."||percentage of glycated hemoglobin||Standard Deviation|Mean
45944|NCT01373346|Secondary|Body Mass Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of weight change after operation in good response group.~BMI(Body Mass index , kg/㎡) was measured.~BMI was obtained using the following formula:~Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of weight after operation in good responder group."||kg/㎡||Standard Deviation|Mean
45945|NCT01373346|Secondary|HOMA-B : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.~HOMA-B was obtained using the following formula:~225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of beta cell function after operation in good responder group."||percentage of beta cell function||Standard Deviation|Mean
45994|NCT01372813|Primary|Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR))|Clinical response is the best response recorded from the start of treatment until disease progression. Clinical response is assessed by the Response Evaluation in Solid Tumors (RECIST) criteria. A partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. A complete response (CR) is the disappearance of all target lesions.|12 months|||Participants|||Number
45946|NCT01373346|Secondary|HOMA-IR : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin resistance after operation in good response group.~HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.~HOMA-IR was obtained using the following formula:~Glucose(mg/dl) x Insulin/405"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HOMA-IR after operation in good responder group."||units on a scale||Standard Deviation|Mean
45947|NCT01373346|Secondary|QUICKI : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.~The QUICKI is obtained using the following formula:~1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of QUICKI after operation in good responder group."||units on a scale||Standard Deviation|Mean
45948|NCT01373346|Secondary|Matsuda Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group.~The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:~Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of insulin sensitivity after operation in good responder group."||units on a scale||Standard Deviation|Mean
45949|NCT01373346|Primary|Operation Related Mortality|Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.|Until end of study (on average 14.8 months)|All of enrolled patient were included.(N=15)||participants|||Number
45950|NCT01373346|Primary|Albumin|For the evaluation of long-term safety, albumin was measured to determine malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.||g/dl||Standard Deviation|Mean
45951|NCT01373346|Primary|Hemoglobin|For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.||g/dl||Standard Deviation|Mean
45952|NCT01373346|Primary|HbA1c|"For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).~HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin."|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||percentage of glycated hemoglobin||Standard Deviation|Mean
45953|NCT01373346|Secondary|Body Mass Index|"BMI(Body Mass index , kg/㎡) was measured.~BMI was obtained using the following formula:~Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||kg/㎡||Standard Deviation|Mean
45954|NCT01373346|Secondary|HOMA-B|"HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.~HOMA-B was obtained using the following formula:~225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||percentage of beta cell function||Standard Deviation|Mean
45955|NCT01373346|Secondary|HOMA-IR|"HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.~HOMA-IR was obtained using the following formula:~Glucose(mg/dl) x Insulin/405"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||units on a scale||Standard Deviation|Mean
45956|NCT01373346|Secondary|QUICKI|"The quantitative insulin sensitivity check index (QUICKI) was measured.~The QUICKI was obtained using the following formula:~1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation , 6 months after operation , Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||units on a scale||Standard Deviation|Mean
45957|NCT01373346|Primary|Morbidity|"For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected.~*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.~Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix “d” (for ‘disability’) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.~For the evaluation of long-term safety, the patients were evaluated every month after discharge."|Until end of study (on average 14.8 months)|All of enrolled patient were included. (N=15)||participants|||Number
45958|NCT01373346|Secondary|Matsuda Index|"Matsuda Index(Insulin Sensitivity Index) was measured.~The Matsuda index was obtained using the following formula:~Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.||units on a scale||Standard Deviation|Mean
45959|NCT01373294|Other Pre-specified|Comparison of the Correlative Assay|For comparing the correlative assay results of ever-relapsers vs non-relapsers, the combined data with the monotherapy and combination therapy groups would be applied. The participants would be categorized based on 1-year relapse.|1 year post disease response||||||
45960|NCT01373294|Other Pre-specified|Effect of Addition of Revlimid on Cytokines|The immunologic impact of the addition of Revlimid™ to BCG for secondary prevention of non-muscle-invasive transitional cell bladder cancer, in terms of a panel of correlative assays. The effect of addition of Revlimid on cytokines associated with generation of immune response and on cytotoxic T lymphocytes and memory phenotype lymphocytes.|Duration of study treatment and follow-up - average of 12 months||||||
45961|NCT01373294|Secondary|Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|Number of participants with treatment emergent AEs or SAEs per category. SAEs will be specifically labeled as such. Participants were assessed at monthly intervals (corresponding to Revlimid™ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated.|Duration of study treatment and follow-up - average of 12 months|All participants.||participants|||Number
45962|NCT01373294|Primary|Arm A: Progression Free Survival (PFS)|The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison|1 year|Experimental Arm A Group Only.||participants|||Number
45963|NCT01373281|Primary|Density Incidence of Symptomatic Virologically Confirmed Dengue Cases Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|"Symptomatic virologically-confirmed dengue (VCD) cases were defined as acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmed by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Cases defined as number of subjects with at least one symptomatic VCD episode from 28 days post-injection 3 to the end of Active Phase.~Density incidence: data are cases per 100 person-years at risk. Data presented is the sum of individual units of time for which the participants contributed to the analyses. Incidence density was calculated as the number of VCD cases divided by the cumulative person-years at risk."|28 days and up to 14 months post-injection 3|Density incidence of symptomatic virologically confirmed dengue cases were assessed in the Per-Protocol Analysis Set.||Cases per 100 person-year at risk|||Number
45964|NCT01373281|Primary|The Person-years at Risk for Participants With Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|The person-years at risk was the cumulative time (in years) until the participant was diagnosed with VCD or until the end of the active period, whichever came first. Data presented is the sum of individual units of time for which the participants contributed to the analyses. Incidence density was calculated as the number of VCD cases divided by the cumulative person-years at risk. The vaccine efficacy is considered as significant if the lower bound of its 95% CI (exact method by Breslow & Day) is greater than 25%.|28 days and up to 14 months post-injection 3|Vaccine Efficacy Against Symptomatic Virologically confirmed Dengue Cases were assessed in the Per-Protocol Analysis Set.||Cumulative time (in years) until VCD|||Number
45965|NCT01373281|Secondary|Percentage of Subjects With Solicited Injection-site and Systemic Reactions Following Any and Each Injection With CYD Dengue Tetravalent Vaccine|Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited injection site reactions (12-14 years): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 Solicited injection site reactions: Fever, ≥39°C; Headache, Malaise, Myalgia, and Asthenia, Significant, prevents daily activity.|Day 0 up to Day 14 post each vaccination|Solicited injection site reactions and systemic reactions were assessed in a subset of the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Percentage of participants|||Number
45966|NCT01373281|Secondary|Percentage of Flavi Virus-Immuned Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07)|Antibody titers against each dengue virus serotype strain were assessed in the Per-Protocol Analysis Set for Immunogenicity population, i.e. those who received vaccine 3 doses in the Immunogenicity subset only.||Percentage of participants|||Number
45967|NCT01373281|Secondary|Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With CYD Dengue Tetravalent Vaccine|Geometric mean titers against each serotypes of the Dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) in a pre-defined subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).|Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07)|Antibody titers against each dengue virus serotype strain were assessed in a subset of the Full Analysis Set for Immunogenicity (FASI), subjects who received at least one dose of vaccine.||Titers||95% Confidence Interval|Geometric Mean
45968|NCT01373281|Primary|Number of Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|"Symptomatic virologically-confirmed dengue (VCD) cases were defined as acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmed by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Cases defined as number of subjects with at least one symptomatic VCD episode from 28 days post-injection 3 to the end of Active Phase.~The vaccine efficacy is considered as significant if the lower bound of its 95% CI (exact method by Breslow & Day) is greater than 25%."|28 days and up to 13 months post-injection 3|Number of symptomatic virologically confirmed dengue cases were assessed in the Per-Protocol Analysis Set.||Cases per 100 person-years at risk|||Number
45969|NCT01372995|Secondary|Day 84 Mortality|The number of participants who died prior to the end of the study (Day 84) was collected.|Day 84|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11, as one participant withdrew.||participants|||Number
45970|NCT01372995|Secondary|Number of Hospital Mortality Cases|The number of study participants who died while in the hospital was collected.|12 weeks|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11.||participants|||Number
45971|NCT01372995|Secondary|Number of Hospital Acquired Infections|The number of study participants who had a hospital acquired infection.|12 weeks|||participants|||Number
45972|NCT01372995|Secondary|Change in Sequential Organ Failure Assessment (SOFA) Score|Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score.|Baseline, Day 7|SOFA score obtained daily while in the ICU. The portion of the study participants included in the analysis of the change in SOFA score between Baseline and Day 7 is limited to participants having values for both time points..||units on a scale||Standard Deviation|Mean
45973|NCT01372995|Secondary|Duration of Time in Hospital|The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported.|12 weeks|||days||Standard Deviation|Mean
45974|NCT01372995|Secondary|Duration of Time in Intensive Care Unit (ICU)|The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported.|12 weeks|||days||Standard Deviation|Mean
45975|NCT01372995|Secondary|Duration of Time on Ventilator|The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported.|12 weeks|||days||Standard Deviation|Mean
45976|NCT01372995|Secondary|Change in Plasma LL-37 Levels|Plasma LL-37 was measured at Baseline, Day 7 and Day 14.|Baseline, Day 7, Day 14|For the Day 14 analysis there were 8 participants in the Placebo arm, 6 participants in the 250,000 of Vitamin D arm, and 5 participants in the 500,000 of Vitamin D arm.||ng/mL||Inter-Quartile Range|Median
45977|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement.|Day 84|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
45978|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement.|Day 28|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
45979|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement.|Day 21|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
45981|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement.|Day 7|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.||participants|||Number
45982|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.|Baseline|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. At the baseline time point, 10 patients were randomized to the placebo arm, 9 to the arm receiving 250,000 IU of Vitamin D3, and 11 to the arm receiving 500,000 of Vitamin D3.||participants|||Number
45983|NCT01372878|Secondary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference|Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.|1 year, same as study duration|||percentage of participants||95% Confidence Interval|Number
45984|NCT01372878|Primary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference|"Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.~Sensitivity measures the proportion of actual positives which are correctly identified as such.~Specificity measures the proportion of negatives which are correctly identified as such.~positive event defined as patients with polyps ≥6 mm detected by OC procedure."|1 year, same as study duration|||percentage of participants||95% Confidence Interval|Number
45985|NCT01372813|Secondary|Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib)|If an adequate number of responses were seen, the relation of these responses to the presence/absence of inactivating VHL mutations in tumor tissue would have been assessed.|12 months|Not enough samples for meaningful analysis.|||||
45986|NCT01372813|Secondary|The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density|Tumor tissue sections were to be stained with hematoxylin and eosin (H and E) and endothelial cell markers at baseline and specified timepoints following initiation of therapy (when tumor tissue was available)|12 months|Not enough samples for meaningful analysis.|||||
45987|NCT01372813|Secondary|Tumor Tissue Used to Evaluate Von Hippel-Lindau (VHL) Status and/or Components of the Vascular Endothelial Growth Factor (VEGF)/Epidermal Growth Factor Receptor (EGFR) Pathway|Components of the VEGF and EGFR pathways were to be evaluated using Western blot analysis at baseline and specified timepoints following initiation of therapy when tumor tissue was available.|12 months|Not enough samples for meaningful analysis.|||||
45988|NCT01372813|Secondary|Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|Flow dynamics within specific tumor sites will be evaluated based on the results of the DCE-MRI obtained first without contrast enhancement and then after contrast enhancement. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters previously defined (Ktrans, Kep, etc.).|12 months|||Participants with changes|||Number
45989|NCT01372813|Secondary|Number of Circulating Endothelial Cells (CEC) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEC cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.|||||
45990|NCT01372813|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11.5 months|||Participants|||Number
45991|NCT01372813|Secondary|Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Progression free survival is defined as the time from initiation of treatment to either progression or death.~RECIST evaluates tumor response. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For detailed information about RECIST, see the protocol Link module."|12 months|||Days||95% Confidence Interval|Median
45992|NCT01372813|Secondary|Number of Circulating Endothelial Progenitor Cells (CEP) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEP cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.|||||
45993|NCT01372813|Secondary|Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2)|Plasma VEGFR and VEGFR2 would have been measured using the (enzyme-linked immunosorbent assay)ELISA at baseline and specified timepoints following initiation of therapy.|12 months|Not enough samples for meaningful analysis.|||||
46134|NCT01371006|Primary|Group B - Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
45995|NCT01372748|Secondary|Percentage of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|||percentage of participants|||Number
45996|NCT01372748|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA).||participants|||Number
45997|NCT01372605|Secondary|Depression-free Days|Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months|12 months|All participants with at least one depression measure contributed to this analysis.||days||Standard Deviation|Mean
45998|NCT01372605|Secondary|Safety Endpoint|Psychiatric hospitalizations|12 months|||participants|||Number
45999|NCT01372605|Secondary|Self-reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|12 months|All participants completing the 12-month interview contributed data to this analysis. Some participants did not complete the 12-month interview but still completed the study and contributed other data.||units on a scale||Standard Deviation|Mean
46000|NCT01372605|Secondary|Self Reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|6 months|All participants completing the 6-month interview and currently on antiretrovirals contributed to this analysis. Some participants did not complete the 6-month interview but still continued in the study and contributed to later data.||units on a scale||Standard Deviation|Mean
46001|NCT01372605|Secondary|Quality of Life|Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.|6 months|All participants who completed a 6-month research interview contributed data to this endpoint. Some participants did not complete the 6-month interview but still continued in the study and contributed later data.||units on a scale||Standard Deviation|Mean
46002|NCT01372605|Secondary|Number of Participants With Viral Load Below Detection|HIV RNA viral load below the limit of detection at 6 months|6 months|All participants with a viral load available at 6 months. Some individuals without a viral load at 6 months still continued in the study and provided later data.||participants|||Number
46003|NCT01372605|Secondary|Appointment Adherence|Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment|12 months|All participants with available medical chart data on appointment attendance were analyzed. Some participants did not complete the study but still contributed chart abstraction data.||Percent of appts that were kept||Standard Deviation|Mean
46004|NCT01372605|Secondary|Health Care Costs|Total health care costs over 12 months|12 months|All participants were analyzed using all available time points, with multiple imputation used to address missing data.||dollars||Standard Error|Mean
46005|NCT01372605|Secondary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor|12 months|Includes all individuals who completed a 6-month pill count that could be linked to an earlier (usually, 5-month) pill count, so as to calculate adherence. Some individuals did not complete this data point but still continued in the study and contributed later data.||Percentage of expected pills||Standard Deviation|Mean
46006|NCT01372605|Secondary|Depressive Symptoms|Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.|Six months|All those completing a 6-month outcomes interview which resulted in a valid HAMD measure||units on a scale||Standard Deviation|Mean
46007|NCT01372605|Primary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor|Six months post-enrollment|All those completing a 6-month pill count which resulted in a valid adherence measure||observed pills taken as % of expected||Standard Deviation|Mean
46008|NCT01372501|Secondary|Change in Absolute Weight Loss From Baseline to Week 52||Week 52|Per Protocol Population (n=14); subjects who had the device implanted for 52 weeks.||kg||Standard Deviation|Mean
46009|NCT01372501|Primary|Assessment of the % Excess Weight Loss at Week 52 or Last Assessment|Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2|52 Weeks|Full Analysis Set (FAS) population had a device successfully implanted.||%EWL||Standard Deviation|Mean
46010|NCT01372462|Secondary|Borg Dyspnea Score During Constant Workrate Exercise at Isotime|"Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome.~0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome"|Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N|Per Protocol||units on a scale||Standard Deviation|Mean
46432|NCT01367665|Secondary|Symptoms in Metastatic BCC Patients: M.D. Anderson Symptom Inventory (MDASI)|Note: This is an interim safety analysis, efficacy is not reported at this time.|Until disease progression or unacceptable toxicity (approximately 2 years)||||||
46011|NCT01372462|Secondary|SpO2 During Constant Workrate Exercise at Isotime|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg|Per Protocol||percentage of oxyHb saturation||Standard Deviation|Mean
46012|NCT01372462|Primary|Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.|Per protocol analysis||minutes||Standard Deviation|Mean
46013|NCT01372410|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 8 is defined as the value obtained 24 hours after the morning dose administered on Day 7. Analysis was performed using a mixed model with covariates of mean Baseline, period Baseline, treatment, and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each particiapant. Change from Baseline for each treatment period is the trough FEV1 at Day 8 minus the Baseline value for that treatment period.|Baseline and Day 8 of each treatment period (up to Study Day 50)|mITT Population. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 8.||Liters||Standard Error|Least Squares Mean
46014|NCT01372410|Primary|Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. β-FEV1MB-S0 is defined as the covariate (Baseline trough FEV1) effect on the mean Baseline trough FEV1 estimate (S0). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.||fraction of mean estimated Baseline FEV1|||Number
46015|NCT01372410|Primary|Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. ED50 is defined as the potency and is the dose that yields 50% of Emax (maximum predicted FEV1 response). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.||micrograms||95% Confidence Interval|Geometric Mean
46016|NCT01372410|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours After the Morning Dosing on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour post-dose measurements at Day 7 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 23, and 24 hours. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the weighted mean FEV1 at Day 7 minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 7.||Liters||Standard Error|Least Squares Mean
46017|NCT01372410|Secondary|Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period|Serial FEV1 for once daily dosing is recorded at the pre-AM dose (AMD; time 0 hour [h]) and at 1, 3, 6, 9, 12,13, 15, 23, and 24 hours after the AMD on Day 7. For twice daily dosing, the 12 h AMD corresponds to the pre-PM dose (PMD), the 13 h AMD corresponds to the 1 h PMD, the 15 h AMD corresponds to the 3 h PMD, the 23 h AMD corresponds to the 11 h PMD, and the 24 h AMD corresponds to the 12 h PMD in this table. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, period, time, time by period BL interaction, time by mean BL interaction, and time by treatment interaction as fixed effects and participant as a random effect. BL is the value recorded pre-dose on Day 1 of each TP, mean BLis the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each timepoint within a TP is the serial FEV1 measure at that timepoint minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.||Liters||Standard Error|Least Squares Mean
46018|NCT01372410|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate trough FEV1dose response. The Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed separately and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. The fixed-effects parameters of the dose response model include Emax (the maximum predicted FEV1 response), ED50 (potency), and S0 (estimated Baseline FEV1). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Data for Emax and S0 are reported in this table. mITT=Modified Intent-to-Treat; par.=participants; BL=Baseline.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.||Liters||95% Confidence Interval|Geometric Mean
46019|NCT01372384|Secondary|Overall Survival|The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|The ITT population included all patients with at least one valid post-baseline assessment.||Days||Full Range|Median
46020|NCT01372384|Secondary|Safety: Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|All participants who received at least one dose of study medication and had a safety assessment performed post baseline were included in the safety population. Participants were analyzed according to the first dose received during the study.||participants|||Number
46021|NCT01372384|Secondary|Objective Response Rate (Investigator Assessed)|Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.|Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)|The ITT population included all patients with at least one valid post-baseline assessment. Only those participants available at the specified time points were analyzed (represented by n=X).||Percentage||95% Confidence Interval|Number
46022|NCT01372384|Primary|Progression-free Survival (Tumour Assessments According to RECIST Criteria)|Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.|Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.|The Intent-to-treat (ITT population) included all patients with at least one valid post-baseline assessment.||Days||Inter-Quartile Range|Median
46023|NCT01372150|Secondary|Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population||Percentage of Participants|||Number
46024|NCT01372150|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|ITT Population||Percentage of Participants|||Number
46025|NCT01372150|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Baseline and Week 8|ITT Population||Score on a Scale||Standard Error|Mean
46026|NCT01372150|Primary|Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Baseline and Week 8|Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.||Score on a Scale||Standard Error|Mean
46027|NCT01371994|Secondary|Time From Baseline to First Day of Returning to Work|The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.|From Baseline to Week 12|Full analysis set participants who were employed prior to the study.||days||95% Confidence Interval|Median
46048|NCT01371877|Primary|Medication Usage|The Unit of Measure is Efficacy. The primary outcome of this study is to determine if vitamin D supplementation reduces the medication usage in subjects with CUA. Thus, for the outcome of reduction in pills, at 12 weeks, subjects whose pill usage decreases by 2 or more pills per day will be classified as improved. Subjects whose pill consumption did not change or increased will be classified as unchanged.|12 week intervention|||number of pills/day||Standard Deviation|Mean
46028|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant’s assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||Percent activity impairment||Standard Error|Least Squares Mean
46029|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants with available WPAI data at Baseline.||percent activity impairment||Standard Deviation|Mean
46030|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant’s assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||percent overall work impairment||Standard Error|Least Squares Mean
46031|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.||percent overall work impairment||Standard Deviation|Mean
46032|NCT01371994|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant’s assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||percent impairment while working||Standard Error|Least Squares Mean
46033|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.||percent impairment while working||Standard Deviation|Mean
46034|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||Percent work time missed||Standard Error|Least Squares Mean
46035|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.||percent work time missed||Standard Deviation|Mean
46047|NCT01371877|Secondary|Total Urticaria Severity Score at 3 Months|The Unit of Measure is Efficacy. The Total Urticaria Severity Score (USS) ranges from 0 to 93, higher scores = worse symptoms. This secondary outcome of this study is to determine if high dose vitamin D supplementation improves the urticaria severity score (USS). The change in USS will be compared between the groups using the independent sample t-test (assuming the distribution is normal). Logistic regression and multiple linear regression will be used to adjust for possible confounders.|3 month intervention|||units on a scale||Standard Error|Mean
46036|NCT01371994|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline and Week 12|"Full analysis set with available ICIQ-SF data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||units on a scale||Standard Error|Least Squares Mean
46037|NCT01371994|Secondary|International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline|Full analysis set with available ICIQ-SF QOL data at Baseline.||units on a scale||Standard Deviation|Mean
46038|NCT01371994|Secondary|Change From Baseline in American Urology Association Quality of Life (QOL) Score|"The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUA data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||units on a scale||Standard Error|Least Squares Mean
46039|NCT01371994|Secondary|American Urology Association Quality of Life (QOL) Score at Baseline|The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).|Baseline|Full analysis set with available AUA QOL data at Baseline.||units on a scale||Standard Deviation|Mean
46040|NCT01371994|Secondary|Change From Baseline in American Urology Association Symptom Score (AUASS)|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUASS data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||units on a scale||Standard Error|Least Squares Mean
46041|NCT01371994|Secondary|American Urology Association Symptom Score (AUASS) at Baseline|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst)."|Baseline|Full analysis set with available AUASS data at Baseline.||units on a scale||Standard Deviation|Mean
46042|NCT01371994|Secondary|Change From Baseline in Average Daily Pad Usage|"Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Weeks 4, 8 and 12|"Full analysis set with available pad usage data at both Baseline and each time point; n indicates the number of participants with available data at each time point."||pads||Standard Error|Least Squares Mean
46043|NCT01371994|Secondary|Average Daily Pad Usage at Baseline|Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.|Baseline (7 days prior to Day 1)|Full analysis set with available pad usage data at Baseline.||pads||Standard Deviation|Mean
46044|NCT01371994|Secondary|Percentage of Participants Who Gain Continence During 12-week Treatment Period|"Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period.~End of treatment is the last on-treatment assessment during the treatment period."|Weeks 4, 8, and 12|Full analysis set; the calculation of percentage of participants uses the full analysis set as the denominator at each time point.||percentage of participants|||Number
46045|NCT01371994|Primary|Time From First Dose to Urinary Continence|Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.|12 weeks|Full analysis set defined as all randomized participants who took at least one dose of study drug and had at least one efficacy endpoint evaluation.||days||95% Confidence Interval|Median
46046|NCT01371877|Secondary|Number of Participants With Adverse Events|Unit of Measure is Safety and Tolerability. The number of participants with adverse events will be compared between the groups using the independent sample t-test (assuming the distribution is normal).|3 month study trial|No significant adverse events. All subjects in the high vitamin D3 group completed the study; 4 subjects in the low vitamin D3 600 IU/day withdrew from the study (1 for pregnancy and 3 unknown). There was no evidence of hypercalcemia.||participants|||Number
46252|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
46049|NCT01371851|Primary|Change in Psychostimulant-positive Urines Over Time|Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.|twice-weekly urine samples (8 weeks)|Those eligible participants who received at least one dose of study medication.||proportion of psychostimulant-pos urines|Participants|Standard Deviation|Mean
46050|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in ME Population||21-42 days after last dose of study drug|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations||Participants|||Number
46051|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population||21-42 days after last dose of study drug|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).||Participants|||Number
46052|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population||21-42 days after last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome). For this measure only patients who were cured at TOC could be assessed for relapse.||Participants|||Number
46053|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population||21-42 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. For this measure only patients who were cured at TOC could be assessed for relapse.||Participants|||Number
46054|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population||7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).||Participants|||Number
46055|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.||Participants|||Number
46056|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.||Participants|||Number
46057|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).||Participants|||Number
46058|NCT01371838|Secondary|Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.||Participants|||Number
46059|NCT01371838|Secondary|Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.||Participants|||Number
46060|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in ME Population||7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.||Participants|||Number
46061|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in mMITT Population||7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).||Participants|||Number
46062|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.||Participants|||Number
46063|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in CE Population||Last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).||Participants|||Number
46064|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in MITT Population||Last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.||Participants|||Number
46065|NCT01371838|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population|Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome|7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).||Participants|||Number
46066|NCT01371825|Secondary|Percentage of Subjects Achieving Transfusion-free Hemoglobin Normalization|The percentage of subjects achieving transfusion-free hemoglobin normalization (TFHN) of ≥ 4 weeks at any time during the study (also referred to as short-term TFHN), and the percentage of subjects who maintained TFHN for ≥ 13 weeks beginning at Week 6 (also referred to as sustained early TFHN). A subject was considered to have achieved short-term TFHN if the/she had two post-baseline measurements of hemoglobin, obtained at least 4 weeks apart, that were above the age-adjusted lower limit of normal (LLN), and had no additional hemoglobin measurements below LLN during this minimum 4-week period and no transfusions administered during the minimum 4-week period or for 2 weeks prior to the start of this period.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Analysis Set (PES) who received treatment with sebelipase alfa for at least 4 weeks (and could therefore be assessed for short-term TFHN). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||percentage of subjects|||Number
46067|NCT01371825|Secondary|Change in Serum Ferritin|Change from baseline in serum ferritin|from week 0 to week 1|Subjects in the Primary Efficacy Analysis Set (PES) with available data at both baseline and week 1. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||change from baseline (µg/L)||Full Range|Median
46068|NCT01371825|Secondary|Changes in Serum Transaminases|Change from baseline for alanine aminotransferase (ALT) and aspartate aminotransferase (AST)|from week 0 to weeks 1 and 4|Subjects in the Primary Efficacy Analysis Set (PES) with available data at both baseline and week 1 (or week 4). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||Change from baseline (U/L)||Full Range|Median
46069|NCT01371825|Secondary|Dichotomous Growth Status Indicators|The percentages of subjects meeting criteria for each dichotomous indicator of under nutrition, i.e., underweight (at least 2 SD below median for weight-for-age [WFA]), wasting (at least 2 SD below median for weight-for-length or -height [WFL/WFH]), and stunting (at least 2 SD below median for length- or height-for-age [LFA/HFA])|Month 12 of treatment|Subjects in the Primary Efficacy Analysis Set (PES) with available anthropometric data at Month 12 of treatment as of the data cut-off date (10 June 2014). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||percentage of subjects|||Number
46070|NCT01371825|Secondary|Effect on Growth Parameters (Weight-for-age)|Changes from baseline in percentiles for weight-for-age (WFA)|from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Analysis Set (PES) who had growth failure at baseline and who survived beyond week 4 of treatment. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||subjects|||Number
46071|NCT01371825|Secondary|Median Age at Death||from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Ananlysis Set (PES) who died. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.||months||Full Range|Median
46072|NCT01371825|Secondary|Percentage of Subjects in the PES Surviving at 24 Months of Age|The percentage of subjects in the Primary Efficacy Analysis Set (PES) who survived to at least 24 months of age.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. Non-evaluable subjects (n=4) were defined as subjects who were alive, still in the study, and had not yet reached 24 months of age.||percentage of subjects|||Number
46073|NCT01371825|Secondary|Percentage of Subjects in the PES Surviving at 18 Months of Age|The percentage of subjects in the Primary Efficacy Analysis Set (PES) who survived to at least 18 months of age.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. Non-evaluable subjects (n=3) were defined as subjects who were alive, still in the study, and had not yet reached 18 months of age.||percentage of subjects|||Number
46074|NCT01371825|Primary|Percentage of Subjects in the PES Surviving to 12 Months of Age|The primary efficacy endpoint was the percentage of subjects (%) in the Primary Efficacy Analysis Set (PES) who survived to at least 12 months of age.|From week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. All 9 subjects were evaluable.||% of subjects||95% Confidence Interval|Number
46075|NCT01371786|Secondary|Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8, and 10 minutes post dose|Scinitigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
46433|NCT01367665|Secondary|Quality of Life: Skindex-16 Questionnaire|Note: This is an interim safety analysis, efficacy is not reported at this time.|Until disease progression or unacceptable toxicity (approximately 2 years)||||||
46076|NCT01371786|Secondary|Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
46077|NCT01371786|Secondary|Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8 and 10 minutes post dose|Scinitgraphic Population||percentage of of radiolabled||Standard Deviation|Mean
46078|NCT01371786|Secondary|Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
46079|NCT01371786|Primary|Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post dose|Scintigraphic Population||percentage of radiolabeled||Standard Deviation|Mean
46080|NCT01371747|Secondary|Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||percentage of participants||95% Confidence Interval|Number
46081|NCT01371747|Secondary|Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||Days||95% Confidence Interval|Median
46082|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||percentage of participants||95% Confidence Interval|Number
46083|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||percentage of participants||95% Confidence Interval|Number
46084|NCT01371747|Secondary|Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days||Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Deviation|Mean
46085|NCT01371747|Secondary|Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Deviation|Mean
46086|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Day 3 were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Day 3|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Error|Least Squares Mean
46087|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Week 8/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Error|Least Squares Mean
46088|NCT01371747|Primary|Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group|Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.||mEq/L||Standard Error|Least Squares Mean
46253|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
46089|NCT01371721|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Percentage of Participants|||Number
46090|NCT01371721|Primary|Percentage of Participants Experiencing a Treatment Emergent Adverse Event||Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031.||Percentage of Participants|||Number
46091|NCT01371721|Secondary|Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Percentage of Participants|||Number
46092|NCT01371721|Secondary|Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Percentage of Participants|||Number
46093|NCT01371721|Secondary|Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Score on a Scale||Standard Deviation|Mean
46094|NCT01371721|Secondary|Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.||Score on a Scale||Standard Deviation|Mean
46095|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Percentage of participants|||Number
46096|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Percentage of participants|||Number
46097|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Percentage of participants|||Number
46469|NCT01366976|Primary|Plasma F2-isoprostane Concentrations|Plasma F2-isoprostane concentrations as a measure of lipid peroxidation|24 hours|||pg/mL||Standard Error|Mean
46098|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Percentage of participants|||Number
46099|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Percentage of participants|||Number
46100|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Percentage of participants|||Number
46101|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Units on a scale||Standard Deviation|Mean
46102|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Units on a scale||Standard Deviation|Mean
46103|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.||Units on a scale||Standard Deviation|Mean
46104|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.||Units on a scale||Standard Deviation|Mean
46105|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030||Percentage of participants|||Number
46106|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030||Percentage of participants|||Number
46107|NCT01371643|Secondary|Percentage of Responders (Only Including Surgical Failures in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months|||percentage of participants||95% Confidence Interval|Number
46108|NCT01371643|Primary|Percentage of Responders (All Treatments)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months|||percentage of participants||95% Confidence Interval|Number
46109|NCT01371643|Primary|Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months|||percentage of participants||95% Confidence Interval|Number
46110|NCT01371565|Primary|Number of Participants With Adverse Events|Safety was assessed at all visits and adverse events were recorded.|6 months|Due to the small number of patients enrolled (N=4), no formal assessments were planned. All patients who received study drug were included in the safety review.||participants|||Number
46111|NCT01371552|Primary|"Percentage of Participants Responding Yes"|The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.|Part 2: Day 7|This reporting group includes all participants who completed Part 2.||Percentage of participants|||Number
46112|NCT01371552|Primary|Lens Wettability|Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.|Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
46113|NCT01371552|Primary|Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear|"The participant circled a number from 1 to 5 in response to the question, Overall, which lens do you prefer - the lens you wore today or your regular lenses? in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Percentage of participants|||Number
46114|NCT01371552|Primary|Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear|"The participant circled a number from 0 to 4 in response to the question, Over the entire day while wearing these contact lenses, how often did your eyes feel dry? in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 2|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Percentage of participants|||Number
46115|NCT01371552|Primary|Mean Overall Ease of Handling at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall ease of handling these lenses? in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
46116|NCT01371552|Primary|Mean Overall Quality of Vision at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall quality of vision while wearing these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
46117|NCT01371552|Primary|Mean Overall Comfort Given at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall comfort of these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.||Units on a scale||Standard Deviation|Mean
46118|NCT01371552|Primary|Mean Value of Comfort During the Day|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the comfort of your lenses over the last hour? in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged."|Part 1: Day 2 at 4 hours, 8 hours, and 12 hours|This reporting group includes all participants who completed 12 hours of lens wear on Day 2.||Units on a scale||Standard Deviation|Mean
46133|NCT01371006|Primary|Group B - Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
46119|NCT01371539|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||logMAR||Standard Deviation|Mean
46120|NCT01371539|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||logMAR||Standard Deviation|Mean
46121|NCT01371006|Secondary|Group B - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.~AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)|all subjects entered in sequence group B of the treated set.||participants|||Number
46122|NCT01371006|Secondary|Group A - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.~AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)|all subjects entered in sequence group A of the treated set.||participants|||Number
46123|NCT01371006|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From first treatment administration (Day 1) up to Day 24|treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication||participants|||Number
46124|NCT01371006|Secondary|Group B - Midazolam: AUC0-∞|Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
46125|NCT01371006|Secondary|Group B - Midazolam: Tmax|Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.||hours||Full Range|Median
46126|NCT01371006|Secondary|Group B - Midazolam: Cmax|Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
46127|NCT01371006|Secondary|Group B - Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group B of the PK set||hours||Full Range|Median
46128|NCT01371006|Secondary|Group A - Efavirenz: Tmax|Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz|All patients entered in sequence group A of the PK set||hours||Full Range|Median
46129|NCT01371006|Secondary|Group A – Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
46130|NCT01371006|Secondary|Group A – Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
46131|NCT01371006|Secondary|Group A – Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence sequence group A of the PK set||hours||Full Range|Median
46132|NCT01371006|Secondary|Group A – Faldaprevir: Cmax,ss|Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
46470|NCT01366976|Secondary|Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)|Changes in urinary NGAL (neutrophil gelatinase-associated lipocalin) as marker of acute kidney injury|24 hours|||ng/mL||Standard Error|Mean
46136|NCT01371006|Primary|Group A - Efavirenz: AUC0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz|all subjects entered in sequence group A of the PK set.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
46137|NCT01371006|Primary|Group A - Efavirenz: Cmax|Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz|all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
46138|NCT01370863|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks|The PAGI-SYM contains 20 items and the scores range from 0 (no symptoms)-5 (very severe symptoms) for each item with a total score of 0-100. Higher scores indicate more severe gastrointestinal symptoms.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.||Units on a scale||Standard Deviation|Mean
46139|NCT01370863|Secondary|Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks||Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.||Number of days||Standard Deviation|Mean
46140|NCT01370863|Primary|Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks|This is used to characterize gastric reflux events. The measurements were made over a 24-hour period at baseline and again at week 4.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.||Number of Reflux Events||Standard Deviation|Mean
46141|NCT01370837|Primary|Induration Size as a Response to Intracutaneous Candida Albicans.||48 hours after injection.|||millimeters||95% Confidence Interval|Median
46142|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).~This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects||participants|||Number
46143|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6.~This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (up to week 6)|Per Protocol Population||participants|||Number
46144|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used.~This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.||participants|||Number
46145|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).~This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects||participants|||Number
46146|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6.~This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population||participants|||Number
46147|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used.~This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|||participants|||Number
46148|NCT01370733|Secondary|Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)|"All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change.~This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects||units on a scale||Standard Deviation|Mean
46149|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Per Protocol - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen.~For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population||units on a scale||Standard Deviation|Mean
46150|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Intent to Treat - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen.~For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.||units on a scale||Standard Deviation|Mean
46151|NCT01370694|Secondary|Clinical Response of Tumor to MK-8808/CVP Combination Therapy|The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.|Up to 2 years|All participants with evaluable data||Participants|||Number
46152|NCT01370694|Secondary|Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.|||||
46153|NCT01370694|Secondary|Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.|||||
46154|NCT01370694|Secondary|Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy|Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.|||||
46155|NCT01370694|Secondary|Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP|Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.|||||
46156|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of single agent MK-8808 up to 2 years|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.|||||
46157|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of combination therapy up to 24 weeks|All participants receiving at least one dose of any study drug.||Participants|||Number
46158|NCT01370642|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.||percentage of participants|||Number
46159|NCT01370642|Secondary|Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||Log IU/ml||95% Confidence Interval|Least Squares Mean
46160|NCT01370642|Primary|Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted “Tier 1” safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.||percentage of participants|||Number
46161|NCT01370642|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.|At Week 24 or 48|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
46162|NCT01370642|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
46163|NCT01370642|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
46164|NCT01370642|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.|12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
46165|NCT01370642|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.|24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.||percentage of participants|||Number
46166|NCT01370616|Secondary|Percentage of Participants Who Discontinued Treatment Due to an AE|Participants chose to discontinue treatment or were discontinued from the study by the investigator due to any untoward effects, or for safety reasons such as an AE. The investigator determined whether or not the AE caused the test drug to be discontinued.|Up to day 28|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
46167|NCT01370616|Secondary|Percentage of Participants With Serious AEs (SAEs)|A SAE is an AE occurring at any dose that resulted in any of the following: death, was life threatening, a persistent or significant disability/incapacity, prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect in an offspring, was a cancer, an overdose, or other important medical events requiring medical or surgical intervention.|Up to day 42|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
46168|NCT01370616|Secondary|Percentage of Participants With Drug-related AEs|A drug-related AE is any AE caused by the test drug as determined by an investigator who is a qualified physician. Drug-relatedness of the AE was assessed by evidence that the participant was actually exposed to the test drug, whether the AE followed a reasonable temporal sequence from administration of the test drug, and whether or not the AE was more reasonably explained by another source.|Up to day 42|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
46169|NCT01370616|Secondary|Percentage of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the investigational product, whether or not considered related to the use of the medicinal product. This also includes any change in frequency and/or intensity of a preexisting condition which is temporally associated with the use of the medicinal product.|Up to day 42|Participants who received at least one dose of IV study therapy||Percentage of participants|||Number
46170|NCT01370616|Secondary|Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for both a favorable clinical response (clinical improvement or cure) and a favorable microbiological response (eradication or presumptive eradication). Clinical improvement means that most pretherapy signs and symptoms of the index infection, had resolved, and no further IV antibiotic therapy is required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. Eradication means that the original pathogen was absent from the last available culture obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy and clinical assessment, appropriate antimicrobial therapy, and microbiological assessment. One participant from the Ertapenem arm with indeterminate clinical response, was excluded from the analysis. A modified LOCF (failure was carried forward), was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
46171|NCT01370616|Secondary|Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable microbiological response, defined as eradication or presumptive eradication. Eradication means that the original pathogen was absent from the last available culture of an adequate specimen obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy, adequate clinical assessment, appropriate antimicrobial therapy, and proper microbiological assessment. A modified LOCF, where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
46172|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 15 up to Day 38|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at FUA, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
46173|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at Day 5, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
46174|NCT01370616|Primary|Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5 up to Day 28|Participants with confirmed clinical diagnosis, adequate IV study therapy, protocol-specified visit at DCIV, and no protocol-specific exclusions. A modified last-observation-carried-forward (LOCF), where only failure was carried forward, was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
46175|NCT01370603|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
46176|NCT01370603|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
46177|NCT01370603|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
46178|NCT01370603|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
46179|NCT01370603|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|"Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have~substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period."||Percentage Change||95% Confidence Interval|Least Squares Mean
46180|NCT01370603|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.||Percentage Change||95% Confidence Interval|Least Squares Mean
46181|NCT01370590|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
46182|NCT01370590|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
46183|NCT01370590|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
46184|NCT01370590|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
46185|NCT01370590|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
46186|NCT01370590|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
46187|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Per-protocol analysis set||Percentage of heartburn free days||Standard Deviation|Mean
46188|NCT01370538|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14|Full Analysis Set||Participants|||Number
46189|NCT01370538|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to day 14|Full Analysis Set||Participants|||Number
46193|NCT01370525|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14|||Participants|||Number
46194|NCT01370525|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to the day 14|Full Analysis Set||Participants|||Number
46195|NCT01370525|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.|From randomisation to day 14|Full Analysis Set||Participants|||Number
46196|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set||Percentage||Standard Deviation|Mean
46197|NCT01370460|Secondary|Postoperative Transfusion Rate|Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.|participants will be followed for the duration of hospital stay, an expected average of 3 days|||participants|||Number
46198|NCT01370460|Primary|Blood Loss|Preoperative and lowest postoperative hemoglobin|participants will be followed for the duration of hospital stay, an expected average of 3 days|||mL||Standard Deviation|Mean
46199|NCT01370408|Secondary|Number of Patients That Experience Treatment Failure Within the First 24 Hours|Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours|24 hours|||participants|||Number
46200|NCT01370408|Secondary|Number of Patients That Required First Administration of Rescue Medication Within 24 Hours|Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours|24 hours|||participants|||Number
46201|NCT01370408|Secondary|Patients Who Experience First Emetic Episode Within 24 Hours|Number of patients with first emetic episode experienced within 24 hours|24 hours|||participants|||Number
46202|NCT01370408|Secondary|Emetic Episodes|Number of emetic episodes|120 Hours|||episodes||Full Range|Mean
46203|NCT01370408|Secondary|Complete Control Rate for Nausea & Vomiting|Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)|120 hours|||participants|||Number
46204|NCT01370408|Secondary|Complete Remission During Overall Chemotherapy Time Period|Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period|120 hours|||participants|||Number
46205|NCT01370408|Secondary|Complete Remission During Acute Phase Post-chemotherapy|Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)|24 hours|||participants|||Number
46206|NCT01370408|Primary|Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting|Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.|120 hours|||participants|||Number
46207|NCT01370356|Secondary|Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation|"The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant`s smoking status and other nicotine use was evaluated based on the last 4 weeks questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?; and Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
46208|NCT01370356|Secondary|Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation|"The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant`s smoking status and other nicotine use was evaluated based on the last 7 days questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 7 days?; and Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 12, 24, and 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
46209|NCT01370356|Secondary|Percentage of Participants With CO Confirmed Long Term CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Weeks 21 - 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
46210|NCT01370356|Secondary|Percentage of Participants With CO Confirmed 4-Week CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 21 - 24|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
46211|NCT01370356|Primary|Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking|Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 15 - 24|The Full Analysis Set was referred to as the Intent-to-Treat (ITT) population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.||percentage of participants|||Number
46212|NCT01370265|Secondary|Hyperemic Blood Pressure (mmHg)|Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||mmHg||Standard Deviation|Mean
46213|NCT01370265|Secondary|Heart Rate (Beats Per Minute (BPM))|The resting heart rate was measured approximately 35 minutes after arrival in the PET unit. The hyperemic heart rate was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||bpm||Standard Deviation|Mean
46214|NCT01370265|Secondary|Segmental CFR|CFR was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||ratio||Standard Deviation|Mean
46215|NCT01370265|Secondary|Hyperemic Segmental MBF|"Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes.~The hyperemic MBF was measured approximately 4 hours after arrival in the PET unit, depending on the randomization."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||mL/min/gm||Standard Deviation|Mean
46216|NCT01370265|Secondary|Global Cardiac Flow Rate|Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||ratio||Standard Deviation|Mean
46217|NCT01370265|Secondary|Resting Global MBF and Resting Segmental MBF|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Global Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).~Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes."|Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit|Resting MBF was measured on all subjects prior to the interventions.||ml/min/gm||Standard Deviation|Mean
46218|NCT01370265|Primary|Global Hyperemic Myocardial Blood Flow (MBF)|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).~The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.||mL/min/gm||Standard Deviation|Mean
46219|NCT01370083|Secondary|Tongue-palate Pressure Amplitude for Maximum Isometric Pressures|We will measure the amplitude of peak tongue-pressure amplitudes on maximum isometric pressure tasks performed using the Iowa Oral Performance Instrument. The maximum amplitude across a series of 3 maximum isometric pressure tasks performed with the bulb in a posterior position (flat end aligned with the first molar tooth) will be used to document tongue strength.|Post-treatment value|Individuals with complete pre and post-treatment data available||Kilopascals||Standard Deviation|Mean
46220|NCT01370083|Secondary|Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows|The Penetration-Aspiration Scale is an 8-point ordinal scale that addresses the depth of airway invasion and response to airway invasion during swallowing. We will measure penetration-aspiration for a series of 3 X 5 cc thin liquid swallows in videofluoroscopy. The participant's worst score will be taken to reflect their swallowing safety. This score will be collapsed into a binary score < vs. > 3 on the scale, reflecting material entering and remaining in or below the supraglottic space (versus transient entry or no entry at all).|Post-treatment (12 weeks)|Participants with complete pre and post-treatment videofluoroscopy data available.||participants|||Number
46221|NCT01370083|Primary|Change in Swallow Response Time for 5 cc Thin Liquid Swallows|Swallow response time (the time duration between bolus passing the ramus of the shadow of the mandible and onset of hyolaryngeal excursion for airway protection 5cc thin liquid barium boluses in videofluoroscopy. Measures > 350 ms are considered to reflect impairment and a heightened risk of penetration-aspiration. The participant's mean swallow response time will be calculated across a series of 3 X 5 cc swallows and then reduced to a binary score < vs > 350 milliseconds.|Post treatment (12 weeks)|||participants|||Number
46222|NCT01370005|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of participants with confirmed hypoglycaemic adverse events|From drug administration until last drug administration plus seven days, up to 171 days|Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.||participants|||Number
46223|NCT01370005|Secondary|Orthostatic Blood Pressure|Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.|Baseline and 12 weeks|Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.||participants|||Number
46224|NCT01370005|Secondary|Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight|A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure > 3 mmHg from baseline and reduction of weight from baseline > 2%|Baseline and 12 weeks|"Patients in the full analysis set (FAS). Treatment assignment as randomised.~Non-completers (missing data due to early discontinuation, values after start of rescue medication or changes in antihypertensive therapy) considered 'failure' was used as the imputation rule."||participants|||Number
46225|NCT01370005|Secondary|Proportion of Patients Reaching Blood Pressure <130/80 mmHg|Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment|Baseline and 12 weeks|"Patients in the FAS without blood pressure control at baseline. Blood pressure control is defined as DBP<80 mmHg and SBP <130 mmHg. Treatment assignment as randomised.~Non-completers (missing data due to early disc, values after start of rescue medication or changes in antihyp. therapy) considered 'failure' was used as the imputation rule."||participants|||Number
46226|NCT01370005|Secondary|Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in trough mean seated DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46227|NCT01370005|Secondary|Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46228|NCT01370005|Secondary|Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in nighttime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46229|NCT01370005|Secondary|Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in nighttime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46230|NCT01370005|Secondary|Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in daytime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46231|NCT01370005|Secondary|Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in daytime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46232|NCT01370005|Secondary|Body Weight Change From Baseline|Change from baseline in body weight after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."||kg||Standard Deviation|Mean
46233|NCT01370005|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|Change from baseline in FPG after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."||mg/dL||Standard Deviation|Mean
46234|NCT01370005|Secondary|Proportion of Patients With HbA1c <7%|Proportion of patients with HbA1c <7% after 12 weeks.|Baseline and 12 weeks|"Patients in the full analysis set (FAS) and with baseline HbA1c >= 7%. Treatment assignment as randomised.~Non-completers (missing data due to early discontinuation or values after start of rescue medication) considered 'failure' was used as the imputation rule."||participants|||Number
46235|NCT01370005|Secondary|Mean 24-hour Diastolic Blood Pressure Change From Baseline|Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46236|NCT01370005|Primary|Mean 24-hour Systolic Blood Pressure Change From Baseline|Change from baseline of mean 24-hour systolic blood pressure (SBP).|Baseline and 12 weeks|"FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."||mmHg||Standard Deviation|Mean
46254|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis|||participants|||Number
46237|NCT01370005|Primary|HbA1c Change From Baseline|Change from baseline in HbA1c after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||percentage of HbA1c||Standard Deviation|Mean
46238|NCT01369888|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months, 9 days|||participants|||Number
46239|NCT01369888|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL.|Intravenous recombinant IL-15 as a daily intravenous bolus for 10 consecutive days in patients with metastatic melanoma who have received a lymphodepleting chemotherapy and ACT TIL with dose escalation (i.e., dose level 1: 0.25 mcg, dose level 2: 0.50 mcg, dose level 3: 1 mcg, and dose level 4: 2 mcg) to further characterize the safety of the MTD prior to starting the phase 2 portion.|2 years|||mcg/kg/day|||Number
46240|NCT01369875|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 years|||Participants|||Number
46241|NCT01369875|Primary|Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|3 years|||Participants|||Number
46242|NCT01369849|Secondary|Treatment-free Survival|The distribution of treatment free survival will be estimated using the method of Kaplan-Meier.|Time from registration to the date of initiation of subsequent therapy or death, assessed up to 5 years||||||
46243|NCT01369849|Secondary|Overall Response Rate, Estimated by the Total Number of Complete or Partial Responses (CR, CRi, CCR, nPR, or PR) Divided by the Total Number of Evaluate Patients|Exact binomial 95% confidence intervals for the true overall response rate will be calculated.|3 months post-treatment||||||
46244|NCT01369849|Secondary|Minimal-residual Disease|Minimal residual disease will be evaluated after treatment in patients who achieve a clinical response. Minimal residual disease status will be explored in relation to both the quality and duration of response.|Up to 5 years||||||
46245|NCT01369849|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|The date at which the patient’s objective status is first noted to be a CR, CRi, CCR, nPR, or PR to the earliest date progression is documented, assessed up to 5 years||||||
46246|NCT01369849|Secondary|Biomarker Analysis (IgVH Gene Mutation, CD38, CD49d, ZAP-70 and FISH Status)|Nonparametric quantitative comparisons by group will be made as appropriate (Fisher’s exact, Wilcoxon rank sum, or Kruskal-Wallis test).|Baseline||||||
46247|NCT01369849|Primary|Proportion of Complete Response Defined to be a CR or CRi Noted as the Objective Status (Phase II)|"A Complete Response (CR) is defined by the NCI Working Group criteria and requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy (e.g. lymph nodes >1.5 cm) by physical examination.~No hepatomegaly or splenomegaly by physical examination.~Absence of constitutional symptoms.~Neutrophils ≥1500/ul.~Platelets >100,000/ul (untransfused).~Hemoglobin >11.0 gm/dl (untransfused)~Peripheral blood lymphocytes <4000/uL~Patients who fulfill all criteria for a CR but who have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity rather than residual CLL will be classified as CR with incomplete marrow recovery (CRi).~The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|From registration to response, up to 84 days|All eligible patients treated at Dose Level 1 were included in the Phase II primary endpoint. All 6 patients from Phase I, Dose level 1 and 4 of the 5 patients registered to the Phase II portion of the study were eligible for this endpoint.||percentage of participants||95% Confidence Interval|Number
46248|NCT01369849|Primary|Maximum Tolerated Dose of Akt Inhibitor MK2206 (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.The number of patients reporting a dose-limiting event are reported.|Up to 35 days|Only the patients registered to the Phase I portion of this study were analyzed for this endpoint. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 are included in this endpoint.||Patients reporting Dose-Limiting Events|||Number
46249|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse|||mg/100ml||Standard Deviation|Mean
46250|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse|||participants|||Number
46251|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse|||participants|||Number
46471|NCT01366976|Primary|Plasma Isofuran Concentrations|Plasma isofuran concentrations as a measure of lipid peroxidation|24 hours|||pg/mL||Standard Error|Mean
46257|NCT01369784|Secondary|Response to Second Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.~Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After second line of treatment|||participants|||Number
46258|NCT01369784|Secondary|Response to First Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.~Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After first line treatment|||participants|||Number
46259|NCT01369784|Secondary|Ann Arbor Staging|Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition|At the beginning of the 2nd line of treatment|||percentage of patients|||Number
46260|NCT01369784|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status|ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus|At the beginning of the 2nd line of treatment|||participants|||Number
46261|NCT01369784|Secondary|MUM-1 Expression|immunohistochemical reaction of cells with MUM-1 antibody|At the beginning of the 2nd line of treatment|||percentage of participants|||Number
46262|NCT01369784|Secondary|Multiple Myeloma Oncogene 1 (MUM-1) Expression|immunohistochemical reaction of cells with MUM-1 antibody|At diagnosis|||percentage of participants|||Number
46263|NCT01369784|Secondary|p53 Expression|immunohistochemical reaction of cells with p-53 antibody|At the beginning of the 2nd line of treatment|||percentage of participants|||Number
46264|NCT01369784|Secondary|p-53 Expression|immunohistochemical reaction of cells with p-53 antibody|At diagnosis|||percentage of participants|||Number
46265|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|The IPI is based on the evaluation of 5 clinical factors: age > 60 years Ann Arbor stage III or IV disease > 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.|At the beginning of the 2nd line of treatment, an average of 2 years|||percentage of patients|||Number
46266|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At the beginning of the second line of treatment|||percentage of participants|||Number
46267|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At diagnosis|||participants|||Number
46268|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At the beginning of the 2nd line of treatment|||participants|||Number
46269|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At diagnosis|||percentage of participants|||Number
46270|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|Data will be recorded from diagnosis to second line response, an expected average of 7 months|At diagnoses|||percentage of participants|||Number
46271|NCT01369745|Secondary|Time to Failure (Days)|Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.|Baseline to 12 weeks|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
46272|NCT01369745|Secondary|Multidimensional Assessment of Fatigue (MAF) at Week 12|"The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week.~To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15.~Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they do not do any activity for reasons other than fatigue. If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index."|week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
46273|NCT01369745|Secondary|Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks|The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.|Week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
46274|NCT01369745|Secondary|Change From Baseline in DAS28-CRP Individual Components at 12 Weeks|"The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity."|Baseline to week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.|||||
46275|NCT01369745|Primary|Change From Baseline in DAS28-CRP at 12 Weeks|"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores."|baseline to week 12|The efficacy analysis population includes all 252 subjects who received at least one dose of study drug after randomization and who provided at least one post-baseline measurement of the primary endpoint||units on a scale||Standard Deviation|Mean
46276|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria||upto 7 days after surgery|||participants|||Number
46277|NCT01369732|Secondary|the Duration of Hospital Stay|Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.|upto 1 month after surgery||||||
46278|NCT01369732|Secondary|the Duration of ICU Stay|Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery||||||
46279|NCT01369732|Secondary|the Duration of Mechanical Ventilation|Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery||||||
46280|NCT01369732|Secondary|Mortality|Participants will be followed for the mortality, an expected average of 1 month after surgery.|upto 1 month after surgery||||||
46281|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria|Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.|upto 7 days after surgery||||||
46282|NCT01369706|Primary|Electromagnetic Interference|inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function|time during exposure to hand-held metal detector (2x 30 sec)|Electromagnetic interference||participants|||Number
46283|NCT01369680|Secondary|Pain Control|"Subjects will be assessed for clinically significant change in pain scores during and after study drug administration. Significant change in pain scores were determined at week 2, though week 14 scores were collected as well.~Participants with a 2 point (or greater) decrease in pain scores compared to baseline were considered to have responded. The NRS scale was used, the scale ranges from 0-10, with 10 being the most pain."|Week 2|Number of participants for analysis was determined in negotiation with the FDA for safety of all participants.||participants|||Number
46284|NCT01369680|Secondary|Norketamine Cmax (Measured in ng/mL).|Pharmacokinetic testing will be done during chronic ketamine administration on subjects consenting to additional testing one week into study drug administration. This is to further describe the activity of ketamine in the blood of children when administered chronically and to enable comparison of any clinical effect or toxicity with steady state levels of ketamine in children.|At week 1|All participants consenting for pharmacokinetics were analyzed. No participants in ketamine 1.5 mg/kg/dose group consented for pharmacokinetics.||ng/mL||Full Range|Mean
46285|NCT01369680|Secondary|Neurocognitive Effect|"Baseline neurocognitive testing will be done before study drug is given. Subjects will be reassessed for any changes in neurocognitive scores at end of dosing (week 2) and at three weeks off study drug (week 14). Significant changes were measured at week 14 compared to baseline. Week 2 was measured to inform future studies.~The neurocognitive scores are standardized scores with a mean of 100; low scores correlate with low neurocognitive function, while high scores correlate with high function. A significant change is defined as greater than or equal to 10% decrease in scores."|At 14 weeks|All participants not lost to follow-up were analyzed||participants|||Number
46286|NCT01369680|Primary|Number of Participants Tolerating Dose|According to CTCae any dose causing grade 2 or worse toxicity will be an untolerated dose. Tolerability is defined as ability to take the medication for 2 weeks without having a grade 2 or worse toxicity.|Up to 2 weeks|Number of participants was determined through negotiation with the FDA for safety of all participants.||participants|||Number
46287|NCT01369641|Primary|Efficacy of Intratympanic Sodium Thiosulfate (STS)|"To assess the efficacy of intratympanic sodium thiosulfate (STS) on reducing the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy using puretone and speech audiometry, and distortion product otoacoustic emissions (DPOAE).~Pure tone and speech audiometry: hearing will be assessed prior to any initiation of cisplatin therapy, again at three weeks, 6 weeks, 12 weeks, and every 6 months thereafter for up to one year."|Through 1 year post-treatment||||||
46288|NCT01369615|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.|Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).|The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.||participants|||Number
46289|NCT01369485|Primary|Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week and 12 month median change from baseline in mean urgency (urinary) incontinence episodes (leaks) between treatment groups. The mean of the number of urinary incontinence episodes over 24 hours” is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).~Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov – Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks (Randomized Phase) and 12 Months (Open Label)|||Episodes/day||Inter-Quartile Range|Median
46290|NCT01369485|Secondary|Change Clinical Global Impressions at 12 Weeks|"CGI is an Investigator assessment, which rates the severity of illness at baseline on a scale of 1 (normal, not ill at all) to 7 (Amongst the most extremely ill patients), and then rates improvement at 12 weeks on a scale of 1 (very much improved) to 10 (very much worse). The analysis was based upon the number of patients that much and very much improved."|12 weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to treat||% patients much or very much improved|||Number
46291|NCT01369485|Secondary|Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)|Overall satisfaction with treatment was assessed (OAB-SAT-q) an 11 question list with multiple scaled checkboxes to allow the subject to rate the treatment with regard to satisfaction, bother from side effects, treatment endorsement, and convenience.|12 weeks|Intent to treat population for those who had prior treatment for OAB.||percentage of patient prefer treatment|||Number
46292|NCT01369485|Secondary|Assessment of Treatment Benefit Scale (TBS)|TBS is a patient-reported outcome comprised of a 4-point scale of checkboxes to describe the change in condition during treatment (greatly improved to worsened). Improvement was defined as a change in the patient's assessment of overall condition to improved or greatly improved over the course of treatment. Analysis was based upon the number of patients who reported an improvement in condition.|12 Weeks|Intent to Treat||percentage patients improved (responded)|||Number
46293|NCT01369485|Secondary|Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.|PPBC is a 6-point scale (from 'no problems at all' to ‘many severe problems’) describing the problem level of the bladder condition at that moment. Improvement is defined as a reduction in the number and/or severity of observed problems.|12 Weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to Treat||percentage of patients that improved|||Number
46294|NCT01369485|Secondary|Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12|The OAB-q is validated to measure symptom bother and life impact due to OAB. It consists of an 8-item Bother Scale to assess individual symptoms and a 25-item HRQL scale that in turn consists of 4 subscales (coping-8 items, concern-7 items, sleep-5 items and social-5 items) to assess impact on life. Responses for each item in the Bother Scale range from 1 (bothered not at all by the symptom) to 6 (Bothered A Very Great Deal). Scores are then added generating an overall Bother Score (severity) ranging from 8 to 48. For HRQL, individual responses range between 1-None of the Time to a 6-All of the Time. Subscale scores range from 8-48 (coping) 7-42 (concern), 5-30 (sleep) and 5-30 (social). Subscale scores are then added to generate the HRQL ranging between 25-150. Raw HRQL scores are transformed for standardization purposes as follows: ((Highest Possible Score-Actual Raw Score)/Range of Scores)*1 00 so that scores could range from 0 (All of the Time) to 100 (None of the Time).|12 Weeks (Randomized Phase) and 12 Months (Open Label).|Intent to Treat||units on a scale||Inter-Quartile Range|Median
46295|NCT01369485|Secondary|Measure Improvement in the Median of the Mean OAB-Symptom Composite Score|"OAB Symptom Composite Score (OAB-SCS) is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence combining the Indevus Urgency Severity Scale (IUSS) for capture of urgency severity per toilet void with 24-hour frequency and UUI episodes.~IUSS Score/void and/or UUI is assigned an OAB-SCS Point/Void: 0(none)=1, 1(mild/easily tolerated)=2, 2(moderate discomfort interfering with activities)=3, 3(severe/extreme urgency discomfort that abruptly stopped all activity or tasks)=4, UUI without void=5.~Overall OAB-SCS Score is calculated for each day by multiplying the OAB-SCS Points/Void and/or UUIs by the number of events meeting criteria and adding the individual scores together. The minimum overall OAB-SCS score in a 24 hour period would be a 1 (representing a single mild void with a OAB –SCS Point/Void score of 0). The score would increase based upon the number voids/events and overall severity each event. Medians calculated for each treatment group."|12 weeks|||units on a scale||Inter-Quartile Range|Median
46296|NCT01369485|Secondary|Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes|"Evaluate the 12 week change from baseline in median for mean number of urgency episodes between the active and sham treatment groups.~Patients were required to complete seven 3-day voiding diaries throughout the course of the study. The voiding diary collected the following information: amount voided (in ml); urgency associated with each toileted void , approximate time of leak, and presence of urge preceding leak.The mean number of urgency episodes over 24 hours was then calculated for each patient during the observation period. The change in median for the mean of the number of urgency episodes over 24 hours) for each treatment group was then calculated.~Distribution of changes from baseline were assessed prospectively using the Kolmogorov – Smirnoff test. The Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks|||Difference in episodes/24 Hours||Inter-Quartile Range|Median
46297|NCT01369485|Secondary|Measure Median Change in Mean Volume Per Void|Evaluate the 12 week median change from baseline in mean volume (ml) per void between the active and sham treatment groups|12 weeks|||ml||Inter-Quartile Range|Median
46321|NCT01368900|Secondary|Patient Satisfaction Questionnaire 90 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.|90 days post-treatment|Data analyzed included subjects completing a 90 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 90 post-treatment photographic images. Responses were tabulated.||percentage of participants Satisfied|||Number
46298|NCT01369485|Secondary|Measure Change in the Median of the Mean Urinary Frequency|"Evaluate the 12 week change from baseline in median urinary frequency between the active and sham treatment groups.~Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov – Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks and 12 Months|||Episodes/24 hours||Inter-Quartile Range|Median
46299|NCT01369485|Primary|Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours” is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).~The primary objective of the open label phase of the study is to evaluate and confirm the continued efficacy of the VERV™ System for long-term use. The primary objective was assessed with rate of responders, where responder was defined as a subject who achieved a decrease of ≥50% in mean urgency urinary incontinence episodes at 12 weeks compared to baseline."|12 weeks (Randomized Phase) and 12 Months (Open Label)|Intent to treat population. Responders are defined as patients who had a greater than or equal to 50% decrease in mean number urgency incontinence episodes over 24 hours.||Number of responders|||Number
46300|NCT01369342|Secondary|Number of Participants With CDAI 70 Point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46301|NCT01369342|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46302|NCT01369342|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46303|NCT01369342|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission at Week 8 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46304|NCT01369342|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46305|NCT01369329|Secondary|Number of Participants With CDAI 70-point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46306|NCT01369329|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46307|NCT01369329|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46308|NCT01369329|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46333|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP|"Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.~A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results."|90 Days post-treatment|||participants|||Number
46309|NCT01369329|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.||participants|||Number
46310|NCT01369030|Secondary|Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale|"Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating not at all satisfied and 9 as very satisfied."|Baseline to Endpoint (90 days)|||units on a scale||Full Range|Mean
46311|NCT01369030|Secondary|Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms||Baseline to Endpoint (90 days)|||percentage of participants|||Number
46312|NCT01369030|Primary|Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value 0 represents not at all, 1 several days, 2 indicates more than half the days, and the maximum value 3 stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression."|Baseline to Endpoint (90 days)|Analyses were performed on the 554 patients who had a baseline PHQ-9>=5 and further analyzed by baseline depression severity groups defined by baseline PHQ-9 scores: 5<=PHQ-9<=9; 10<=PHQ-9<=14; 15<=PHQ-9<=19; and 20<=PHQ-9<=27.||units on a scale||Standard Deviation|Mean
46313|NCT01368965|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera treatment|||Average NRS score||Full Range|Mean
46314|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.||percentage of participants Satisfied|||Number
46315|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90 Days post-treatment|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.||percentage of participants Satisfied|||Number
46316|NCT01368965|Secondary|Global Aesthetic Improvement at 180 Days Post-treatment|At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|180 days post-treatment|"Subjects completing the 180-Day SGAIS = 39; however, the 180-Day PGAIS was not obtained for 2 subjects. PGAIS data are based on n=37.~The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"||percentage of participants improved|||Number
46317|NCT01368965|Secondary|Global Aesthetic Improvement at 90 Days Post-treatment|At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|90 Days post-treatment|"The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"||percentage of participants improved|||Number
46318|NCT01368965|Primary|Change in Overall Lifting and Tightening of Treated Tissue|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos|90 days post treatment|Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site.|||||
46319|NCT01368900|Other Pre-specified|Subject Assessment of Pain|Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.|Average pain scores reported during study treatment|The subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated, using a validated numeric rating scale of 0-10 with 1 representing no pain and 10 representing the highest degree of pain.||units on a scale||Full Range|Mean
46320|NCT01368900|Secondary|Patient Satisfaction Questionnaire at 180 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.|180 days post-treatment|Data analyzed included subjects completing a 180 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 180 post-treatment photographic images. Responses were tabulated. 60 of 61 subjects provided responses. One subject's response was missing.||percentage of participants Satisfied|||Number
52891|NCT01287416|Secondary|Lifetime Suicide Attempt at Baseline|Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline|July 19-20, 2010|||participants|||Number
46322|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 180 days post-treatment, per protocol.||percentage of participants improved|||Number
46323|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 90 days post-treatment, per protocol.||percentage of participants improved|||Number
46324|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment|"At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|60 days post-treatment|At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
46325|NCT01368900|Primary|Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes|Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.|90 days post-treatment|Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.||percentage of participants improved|||Number
46326|NCT01368874|Secondary|L'Oreal Photographic Scale 180 Days Post-treatment|"At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|180 Days post-treatment|||units on a scale||Full Range|Mean
46327|NCT01368874|Secondary|L'Oreal Photographic Scale 90 Days Post-treatment|"At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|90 Days post-treatment|||units on a scale||Full Range|Mean
46328|NCT01368874|Secondary|L'Oreal Photographic Scale Baseline|"At baseline, the Principal Investigator (PI) assessed the subjects’ horizontal neck folds, neck sagging, and texture and ptosis changes using the L’Oreal Photographic Scales. The L’Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|Baseline|||units on a scale||Full Range|Mean
46329|NCT01368874|Secondary|Patient Satisfaction Questionnaire 180 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|180 days post-treatment|||Percentage of participants|||Number
46330|NCT01368874|Secondary|Patient Satisfaction 90 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|90 Days post-treatment|||Percentage of participants|||Number
46331|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|180 days post-treatment|At 180 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
46332|NCT01368874|Other Pre-specified|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible.|During Ulthera treatment|||units on a scale||Full Range|Mean
46334|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|90 days post-treatment|At 90 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
46335|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|60 days post-treatment|At 60 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.||percentage of participants improved|||Number
46336|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity|Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.|90 Days post-treatment|||participants|||Number
46337|NCT01368835|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera study treatment|Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed.||Average NRS score||Full Range|Mean
46338|NCT01368835|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available.||percentage of participants improved|||Number
46339|NCT01368835|Secondary|Change in Submental and Neck Skin Laxity by Quantitative Analysis|The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants.||percentage of participants improved|||Number
46340|NCT01368835|Primary|Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants, for a masked assessment.||percentage of participants improved|||Number
46341|NCT01368809|Secondary|Postoperative Pain|"Postoperative pain measured using a Verbal Rating Scale (VRS) at post-anesthesia care unit (PACU), (90 minutes after arriving).~Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain."|one day|||Scores on a scale||Standard Deviation|Mean
46342|NCT01368809|Secondary|Incidence of Nausea and Vomiting|Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.|1 day|||participants|||Number
46343|NCT01368809|Primary|Incidence of Coughing|during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.|one day|||participants|||Number
46344|NCT01368653|Secondary|Prolonged Abstinence|This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.|10 weeks|||participants|||Number
46345|NCT01368653|Secondary|Mediators of Treatment Effects|Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators of the first phase treatment. Additional analyses of reports of emotions, thoughts, and behaviors will explore mediators of non-nicotine cigarette effects on smoking. These measures will be analyzed to see if treatment affects them and if they predict smoking behavior.|1 week post-quit and 6 weeks post-quit||||||
46346|NCT01368653|Secondary|10-week Abstinence|This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.|10 weeks|||participants|||Number
46347|NCT01368653|Primary|4-week Abstinence|7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).|4 weeks|||participants|||Number
46348|NCT01368536|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone||12 weeks|Safety Set — Consists of all patients who received at least one dose of the double-blind study drug. Patients were analyzed according to the treatment that they received.||Participants|||Number
47730|NCT01350232|Secondary|Immune Recovery|To assess the pace of lymphoid recovery and associated risk for opportunistic infections and relapse (return to recipient erythropoiesis) in this patient population.|100 days post infusion through 5 years post infusion||||||
46351|NCT01368536|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment|Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
46352|NCT01368536|Secondary|Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
46353|NCT01368536|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
46354|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At 12 weeks|||units on a scale||Standard Deviation|Mean
46355|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At baseline|||units on a scale||Standard Deviation|Mean
46356|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)."|At 12 weeks|||units on a scale||Standard Deviation|Mean
46357|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)."|At baseline|||units on a scale||Standard Deviation|Mean
46358|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At 12 weeks|||units on a scale||Standard Deviation|Mean
46359|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At baseline|||units on a scale||Standard Deviation|Mean
46360|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable."|12 weeks|||units on a scale||Standard Deviation|Mean
46361|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable."|baseline|||units on a scale||Standard Deviation|Mean
46362|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|12 weeks|||units on a scale||Standard Deviation|Mean
46363|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|Baseline|||units on a scale||Standard Deviation|Mean
46364|NCT01368432|Secondary|Clinical Global Impression (CGI)- Improvement|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.~The scores range from 1-7~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse"|at 12 weeks|||units on a scale||Standard Deviation|Mean
46365|NCT01368432|Secondary|Clinical Global Impression (CGI) - Severity at Baseline|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7~= Normal—not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients."|Baseline|||units on a scale||Standard Deviation|Mean
46366|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.~In this study the score was used as a continuous variable."|MADRS score at 12 weeks|||units on a scale||Standard Deviation|Mean
46367|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.~In this study the score was used as a continuous variable."|MADRS score at baseline|||units on a scale||Standard Deviation|Mean
46368|NCT01368406|Primary|Change in Weight From Baseline to Endpoint|All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes.Measures were collected by the same investigator in all assessments.|baseline, 3-month|||kg||95% Confidence Interval|Mean
46369|NCT01368276|Secondary|Durable Response Rate|"Durable response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) assessed by the investigator, initiating at any time while receiving talimogene laherparepvec or GM-CSF therapy on the 005/05 or the 005/05-E study and maintained continuously for at least 6 months from response initiation. This reflects all new sites of disease as well as disease sites identified at baseline.~Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|Full analysis set||percentage of participants||95% Confidence Interval|Number
46370|NCT01368276|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. Best overall response for a patient is the best overall response observed across all time points and is cumulative (ie, includes responses during the parent study 005/05 and during Study 005/05-E).~Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|The full analysis set for the extension study is defined as all participants who received at least one dose of extension treatment.||percentage of participants||95% Confidence Interval|Number
46371|NCT01368276|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|"AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline:~Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.~Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator.~A serious AE is one that meets one or more of the following criteria/outcomes:~Results in death.~Is life-threatening.~Requires inpatient hospitalization or prolongation of existing hospitalization.~Results in persistent or significant disability/incapacity.~Is a congenital anomaly/birth defect.~Is an important medical event."|From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.|Safety population (randomized participants who received at least one dose of extension treatment).||participants|||Number
46372|NCT01368263|Secondary|PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less||16 weeks|(1) of the participants in Group 1 had an inconclusive PEPI score at week 16 and was not evaluable. (1) of the participants in Group 1 did not have surgery and was not evaluable. Participants in Group 2 and Group 3 were not evaluable for this outcome as the estradiol and Ki67 levels were above outcome specified levels.||percentage of participants|||Number
46373|NCT01368263|Secondary|Preoperative Endocrine Prognostic Index Score (PEPI Score)|To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).|At time of definitive surgery|2 participants in Group 1 did not have a PEPI score at time of surgery as (1) participant did not have nodal dissection and (1) did not have surgery. Both participants in Group 2 and Group 3 did not have surgery study tissue collected||participants|||Number
46374|NCT01368263|Secondary|Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67||Baseline and 4 weeks post-treatment|This outcome was not analyzed due to funding issues.|||||
46375|NCT01368263|Primary|Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy|Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.|6 months post neoadjuvant endocrine therapy and surgery|None of the participants had a PEPI score and 0 and pathological stage 1.|||||
46376|NCT01368263|Primary|Pathologic Complete Response (CR) Rate|"In patients with Ki67 >10% and <= 15 pg/ml at 4 weeks.~The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy."|1 month|There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 >10% and estradiol levels of <= 15 pg/ml at 4 weeks.|||||
46377|NCT01368211|Secondary|Change in Maximum Amplitude at 24-hours Post-transfusion|Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion|pre-transfusion, 24-hour post transfusion|||mm||Standard Deviation|Mean
46384|NCT01368081|Primary|Number of Patients With Drug Related Adverse Events|Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients||participants|||Number
46385|NCT01368081|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Full analysis set||percentage of HbA1c||Standard Error|Least Squares Mean
46386|NCT01368042|Secondary|Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from enrollment (at least 1 month after starting treatment with paricalcitol iv) through 3 months post-enrollment and 6 months post-enrollment.|Enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||pg/mL per month||95% Confidence Interval|Mean
46387|NCT01368042|Secondary|Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months|All enrolled participants with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up).||pg/mL||Standard Deviation|Mean
46388|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)|Ca×P product levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg˄2/dL˄2||Standard Deviation|Mean
46389|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)|Phosphorous levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
46390|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)|Calcium levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
46391|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)|Creatinine levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
46392|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)|Urea levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.||mg/dL||Standard Deviation|Mean
46405|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.|Overactive Bladder subjects answered the Overactive Bladder Questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions # 1 (Frequent urination during the daytime hours?); #5 (Nighttime urination?) and #6 (Waking up at night because you have to urinate?) are asking about frequency. Choices of answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal) 6 (A very great deal). Multiple responses to the questionnaire were averaged for each participant at baseline and at 6 weeks and then all participants' answers were totaled and averaged at baseline and at 6 weeks.|Outcome measure was assessed at baseline and after the 6 week visit.|||scores on a scale||Standard Deviation|Mean
46393|NCT01368042|Primary|Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.|Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale/month||95% Confidence Interval|Mean
46394|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46395|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘General Health Perceptions’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46396|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Bodily Pain’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46397|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Social Functioning’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46398|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Emotional Well-Being’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46406|NCT01367886|Primary|Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment|Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.|Outcome measure was assessed at baseline and at the end of the 6-week treatment|||urinations/day||Standard Deviation|Mean
46399|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Energy/Fatigue’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46400|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46401|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46402|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.||scores on a scale||Standard Deviation|Mean
46403|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..|Overactive bladder subjects answered the Overactive Bladder questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions #2 (An uncomfortable urge to urinate?); #3 (A sudden urge to urinate with little or no warning?); #4 (Accidental loss of small amounts of urine?); #7 (An uncontrollable urge to urinate?); #8 (Urine loss associated with a strong desire to urinate?) are asking about urgency. Choices for answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal); 6 (A very great deal). Multiple responses to the questionnaire was averaged per participant at baseline and at 6 weeks and then all participants answers were totaled and then averaged at baseline and at 6 weeks.|Outcome measures were assessed at baseline and after the 6 week visit.|||scores on a scale||Standard Deviation|Mean
46404|NCT01367886|Primary|Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment|The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.|Outcome measure was assesses at baseline and at the end of the 6-week treatment period.|||scores on Urinary Sensation Scale||Standard Deviation|Mean
46407|NCT01367860|Secondary|VAS for Leg Pain - 12th Month|pain scale - VAS for leg pain - 12th month|12th month from surgery|||units on a scale||Standard Deviation|Mean
46408|NCT01367860|Secondary|VAS for Leg Pain - 6rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery|Intention to treat||units on a scale||Standard Deviation|Mean
46409|NCT01367860|Secondary|VAS for Leg Pain - 3rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery|||units on a scale||Standard Deviation|Mean
46412|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 12th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|12th month from surgery|||units on a scale||Standard Deviation|Mean
46413|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 6th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|6th month from surgery|Intention to treat||units on a scale||Standard Deviation|Mean
46414|NCT01367860|Primary|Oswestry Disability Index (ODI) - 3th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|3th month|Intention to treat||units on a scale||Standard Deviation|Mean
46415|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|1st month from baseline|||units on a scale||Standard Deviation|Mean
46416|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Week|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|1st week minus baseline|Intention to treat||units on a scale||Standard Deviation|Mean
46417|NCT01367860|Secondary|VAS for Lumbar Pain - 12th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|12th month from surgery|||units on a scale||Standard Deviation|Mean
46418|NCT01367860|Secondary|VAS for Lumbar Pain - 6th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery|||units on a scale||Standard Deviation|Mean
46419|NCT01367860|Secondary|VAS for Lumbar Pain - 3rd Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery|||units on a scale||Standard Deviation|Mean
46420|NCT01367860|Secondary|VAS for Lumbar 1st Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery|intention to treat||units on a scale||Standard Error|Mean
46421|NCT01367860|Secondary|VAS for Lumbar - 1st Week|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery|||units on a scale||Standard Deviation|Mean
46422|NCT01367860|Secondary|Clinical Evaluation|"Will be measured dichotomously: (present or absent)~Variables:~Infection; residual pain; herniation recurrency"|6th month|Infection||participants|||Number
46423|NCT01367860|Primary|VAS for Lumbar Pain in 3 Months|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|VAS for Lumbar Pain at 3 Months|intention to treat||units on a scale||Standard Deviation|Mean
46424|NCT01367704|Primary|Change From Baseline to 3 Months Using the Intentions to Intervene Scale|Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from “very unlikely” to “very likely” (minimum = 1 and maximum = 5). This scale was investigator developed by Miller (PI) et al to assess participants report of how likely they would be to do something to stop the behavior and modeled as a mean of 8 items.|3 months|||mean scores||Standard Deviation|Mean
46425|NCT01367704|Primary|Change From Baseline to 3 Months Using the Gender Equitable Attitudes Scale|Assessment of gender-equitable attitudes comparing baseline mean score with follow up mean score, using a 5-point Likert-like scale ranging from “strongly agree” to “strongly disagree” (minimum = 1 and maximum = 5). This scale includes questions modified from Barker’s Gender-Equitable Norms Scale and modeled as a mean of responses to 11 items.|3 months|||mean scores||Standard Deviation|Mean
46426|NCT01367704|Primary|Change From Baseline to 3 Months Using the Recognition of Abusive Behavior Scale|Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from “not abusive” to “extremely abusive” (minimum = 1 and maximum = 5). This scale was developed by Silverman et al to assess perceptions of the degree of abusiveness of specified relationship behaviors and modeled as a mean of responses to 12 items.|3 months|||mean scores||Standard Deviation|Mean
46427|NCT01367665|Secondary|Overall Survival|Note: This is an interim safety analysis, efficacy is not reported at this time.|Until disease progression or unacceptable toxicity (approximately 2 years)||||||
46428|NCT01367665|Secondary|Progression-free Survival|Note: This is an interim safety analysis, efficacy is not reported at this time.|Until disease progression or unacceptable toxicity (approximately 2 years)||||||
46429|NCT01367665|Secondary|Duration of Response|Note: This is an interim safety analysis, efficacy is not reported at this time.|Until disease progression or unacceptable toxicity (approximately 2 years)||||||
46430|NCT01367665|Secondary|Time to Response|Note: This is an interim safety analysis, efficacy is not reported at this time.|Until disease progression or unacceptable toxicity (approximately 2 years)||||||
46434|NCT01367665|Primary|Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)||Baseline to the data cut-off of 06 Nov 2013 (up to 2 years, 6 months)|Safety population: All participants who received at least 1 dose of study medication.||percentage of participants|||Number
46435|NCT01367457|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)|Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||participants|||Number
46436|NCT01367457|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.|From initiation of treatment untill death (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||months||95% Confidence Interval|Median
46437|NCT01367457|Primary|Duration of Response (DOR)|Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
46438|NCT01367457|Primary|Percentage of Participants With Objective Response|Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||percentage of participants|||Number
46439|NCT01367457|Primary|Progression-free Survival (PFS)|Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.||months||95% Confidence Interval|Median
46440|NCT01367249|Secondary|Ocular Pain|The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of “None” on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.|Day 1|LOCF Analysis, ITT Population||eyes|Participants||Number
46441|NCT01367249|Primary|Ocular Inflammation|The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.|Day 15|LOCF Analysis, ITT Population||eyes|Participants||Number
46442|NCT01367158|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination|Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on Safety Set (all subjects in the exposed set who provided post-vaccination solicited AE data).||Number of Subjects|||Number
46443|NCT01367158|Secondary|Numbers of Subjects With Other Unsolicited AEs|Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|Day 8 After vaccination Through Study Termination, up to 6 months|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).||Number of Subjects|||Number
46444|NCT01367158|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).||Number of Subjects|||Number
47143|NCT01358864|Secondary|Early Treatment Success (ETS)|Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.|Week 4 and Week 8|FAS||percentage of participants|||Number
46445|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
46446|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
46447|NCT01367158|Secondary|GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
46448|NCT01367158|Secondary|GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
46449|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
46450|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
46451|NCT01367158|Secondary|GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by Per MITT Set.||Ratio||95% Confidence Interval|Geometric Mean
46452|NCT01367158|Secondary|GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.||Titers||95% Confidence Interval|Geometric Mean
46453|NCT01367158|Secondary|Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT month 7 Set.||Percentages of subjects||95% Confidence Interval|Number
46454|NCT01367158|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.|At month 7|Analysis was done by MITT month 7 Set.||Percentages of subjects||95% Confidence Interval|Number
46472|NCT01366885|Secondary|Number of Mothers Who Developed Side Effects From Vitamin D|Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.|During pregnancy and the 3 years of the child's development|The children born were assessed for whether they developed autism or not.||participants|||Number
46455|NCT01367158|Secondary|GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT Month 7 Set.||Ratio||95% Confidence Interval|Geometric Mean
46456|NCT01367158|Secondary|GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 6 and month 7|Analysis was done by MITT Month 7 Set.||Titers||95% Confidence Interval|Geometric Mean
46457|NCT01367158|Secondary|Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB|At month 7|Analysis was done by MITT Month 7 Set.||Ratio||95% Confidence Interval|Geometric Mean
46458|NCT01367158|Secondary|Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.||Titers||95% Confidence Interval|Geometric Mean
46459|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.||Percentages of subjects||95% Confidence Interval|Number
46460|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).|At month 6 and month 7|Analysis was done by Modified Intention-To-Treat (MITT) Month 7 Set. MITT is defined as all subjects in the enrolled set who received a study vaccination at Month 6 and provided one evaluable serum sample at Month 7.||Percentages of subjects||95% Confidence Interval|Number
46461|NCT01367119|Secondary|Mean Post Anesthesia Recovery Side Effects|Post anesthesia recovery side effects were assessed at the time of discharge from recovery with five patient self-report items: nausea, headache, myalgia, visual disturbance, and confusion. These were rated by the patients on a four point scale (0, 1, 2, 3) – absent, mild, moderate, severe. This means that for each item a subject could score between 0 (no symptoms) and 3 (severe symptoms). Also, degree of recovery room agitation was rated by the nurse on a similar four point scale.|Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure|||units on a scale||Standard Deviation|Mean
46462|NCT01367119|Secondary|Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression.~The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whos treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was mde to administer them 2 days after the last treatment.~Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 65 observations, for the methohexital arm there were 63 observations.||units on a scale||Standard Deviation|Mean
46463|NCT01367119|Primary|Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)|"The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression.~The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment.~Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 54 observations, for the methohexital arm there were 55 observations.||units on a scale||Standard Deviation|Mean
46464|NCT01367080|Secondary|t1/2|Terminal half-time(t1/2) of Amitryptyline in Plasma|Up to 72 hours|||hour||Standard Deviation|Mean
46465|NCT01367080|Secondary|Tmax|Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma|Up to 72 hours|||hour||Standard Deviation|Mean
46466|NCT01367080|Secondary|Cmax|Maximum Concentration(Cmax) of amitryptyline in plasma|Up to 72 hours|||ng/mL||Standard Deviation|Mean
46467|NCT01367080|Primary|AUClast and AUCinf|Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma|Up to 72 hours|||ng*hr/mL||Standard Deviation|Mean
46468|NCT01366976|Secondary|Serum Creatinine|Serum creatinine measured over a 72 hour period|72 hours|||mg/dL||Standard Error|Mean
46473|NCT01366885|Primary|Number of Children Who Developed Autism|The child will be screened by an Modified Checklist for Autism in Toddlers (MCHAT) interview at 18 months of age, and by a questionnaire, the Pervasive Developmental Disorder Behavioral Inventory (PDDBI) at 3 years of age to determine whether the child has developed autism or not.|Child assessed at 3 years of age|Children who developed autism||Children who developed autism|||Number
46474|NCT01366872|Secondary|Radiographic Predictors of Implant Failures and Poor Outcomes|Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.|A Minimum of 2 Years Post Index Procedure|Per protocol, patients who were completely revised were excluded.||participants|||Number
46475|NCT01366872|Secondary|Evaluation of Complication and Reoperation Rates|Number of reported complications/reoperations following the index procedure.|A Minimum of 2 Years Post Index Procedure|Per Protocol||participants|||Number
46476|NCT01366872|Primary|Assessment of Functional Outcomes Following Agility LP Ankle Replacement|Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.|A Minimum of 2 Years Post Index Procedure|Per surgical history (protocol).||Degrees||Standard Deviation|Mean
46477|NCT01366846|Secondary|Proportion of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Per Protocol||percentage of participants|||Number
46478|NCT01366846|Secondary|Proportion of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Intent-to-treat||percentage of participants|||Number
46479|NCT01366846|Primary|Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Per Protocol||percentage of participants|||Number
46480|NCT01366846|Primary|Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|72 months|Per Protocol||percentage of participants|||Number
46481|NCT01366846|Primary|Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat||percentage of participants|||Number
46482|NCT01366846|Primary|Proportion of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat||percentage of participants|||Number
46483|NCT01366638|Primary|Plasma Concentrations of TMC435|"The table below shows the median (range) TMC435 predose plasma concentrations (C0h) and maximum concentration (Cmax) values for participants in each treatment group. “Overall” is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
46484|NCT01366638|Primary|The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h)|"The table below shows the median (range) AUC24h values for TMC435 for all participants in each TMC435 treatment group who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng·h/mL||Full Range|Median
46485|NCT01366638|Primary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFNα-2b) and Ribavirin (RBV) at Week 24|"The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2b and RBV at Week 24. Participants in the TMC435 Treatment-Naïve and TMC435 Prior Relapser treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48 (does not apply to the TMC435 Non-responder treatment group because the specified treatment duration was 48 weeks and RGT criteria was not assessed at Week 24). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24 or 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
46486|NCT01366638|Primary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|"The table below shows the percentage of participants in each treatment group with greater than or equal to 2 log10 IU/mL drop from baseline in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at each time point during treatment and post-treatment follow-up. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT (up to Week 24 or 48), follow-up (FU) Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
46487|NCT01366638|Primary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT)|"The table below shows the number of participants in each treatment group with abnormal ALT levels at Baseline who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at EOT. At Baseline, 15 treatment-naïve participants, 13 prior relapsers, and 13 prior non-responders had abnormal ALT levels at Baseline. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
46488|NCT01366638|Primary|The Number of Participants Demonstrating Viral Relapse|"The table below shows the number of participants in each treatment group who demonstrated viral relapse, defined as having undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at end of treatment (EOT [Week 24 or 48]) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of an assessment of sustained virologic response (SVR). The number of participants analyzed in each treatment group below are those with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
46489|NCT01366638|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period. Viral breakthrough is defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of greater than 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 48 Weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
46499|NCT01366521|Secondary|Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment|Hematology laboratory parameters included platelet count, red blood cells (RBC) count, white blood cell (WBC) count, hemoglobin, hematocrit, reticulocyte count, mean corpuscle volume (MCV), mean corpuscle hemoglobin (MCH), mean corpuscle hemoglobin concentration (MCHC), neutrophils, segmented neutrophils (SN), total neutrophils (TN), lymphocytes, monocytes, eosinophils and basophils assessed at Baseline, Weeks 4, 8, 12 and 20. Hematology abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 (follow-up visit)|Safety Population||Participants|||Number
46490|NCT01366638|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment|"The table below shows the percentage of participants in each treatment group with undetectable HCV RNA less than 1.2 log10 IU/mL during treatment and at end of treatment (EOT). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
46491|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|"The table below shows the percentage of participants in each treatment group with a SVR24 defined as participants with undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment and at 24 weeks after the last dose of treatment (Week 48 or 72). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|24 weeks after the last dose of treatment (Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
46492|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|"The table below shows the percentage of participants in each treatment group with an SVR12 defined as participants with undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma HCV RNA 12 weeks after the last dose of treatment (Week 36 or 60). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of Participants|||Number
46493|NCT01366521|Secondary|Mean Dose Normalized Cmax Ratio to Assess the Relative Bioavailability of SC Mepolizumab as Compared With IV Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed dose-normalized (DM) Cmax were be analyzed using an analysis of variance (ANOVA) model. The ratio for each SC dose group versus IV and across SC doses versus IV will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Percentage||90% Confidence Interval|Mean
46494|NCT01366521|Secondary|Mean AUC to Assess the Absolute Bioavailability of SC Mepolizumab|Population modelling techniques using non-linear mixed effect methods were used to estimate individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed individual clearance estimates were analysed using an analysis of variance (ANOVA) model. The absolute bioavailability for each SC dose group and across SC doses will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population||Percentage||90% Confidence Interval|Mean
46495|NCT01366521|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening (SCR) and Day 3 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and at Day 3|Safety Population||Participants|||Number
46496|NCT01366521|Secondary|Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies by antibody detection (AD) and antibody neutralisation (AN) assay. For participants who prematurely withdrew from the study and had been dosed, immunogenicity testing occurred (if possible) at the time of premature withdrawal and at 16 weeks after dosing (or the end of the study, whichever came first). Serum was tested for the presence of anti-mepolizumab antibodies using the currently approved analytical methodology incorporating screening, confirmation and titration steps. Samples confirmed positive for the presence of anti-mepolizumab antibodies in the original assay were tested for the presence of neutralizing antibodies.|Day 1, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Participants|||Number
46497|NCT01366521|Secondary|Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including heart rate (HR) was measured at Baseline (Pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||beats per minute (BPM)||Standard Deviation|Mean
46498|NCT01366521|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Baseline (pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Millimeter of mercury (mmHg)||Standard Deviation|Mean
46500|NCT01366521|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment|Clinical chemistry laboratory parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB) and direct bilirubin, creatinine, chloride, uric acid, glucose, total carbondioxide (CO2), gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP) and total protein assessed at Baseline, Weeks 4, 8, 12 and 20. Laboratory abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Baseline (Day 1 pre-dose), Weeks 4, 8, 12 and 20|Safety Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Participants|||Number
46501|NCT01366521|Primary|Terminal Half-life (t½) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Terminal half-life (t1/2) was estimated by modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters for mepolizumab from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population||Days||95% Confidence Interval|Mean
46502|NCT01366521|Primary|Time to Maximum Plasma Concentration (Tmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Time to maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||hours||Full Range|Median
46503|NCT01366521|Primary|Maximum Plasma Concentration (Cmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
46504|NCT01366521|Primary|Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab|AUC of mepolizumab was estimated by population modeling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Individual cumulative plasma of mepolizumab AUC to Day 84 (cumAUC(0-day 84)), is the sum of the AUCs over each dosing interval after each of the three doses administered, for those participants with data up to Day 84. Individual cumulative plasma of mepolizumab AUC to Day 140 (cumAUC(0-day 140) is the sum of the AUCs over each dosing interval after each of the three doses administered plus the AUC post the last dose interval up to Day 140 (i.e. from Day 84 to Day 140). Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 hour (h), 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|Pharmacokinetic (PK) Population: all participants randomized to treatment and who received at least one dose of study treatment and who have at least one PK sample taken and analyzed. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).||Nanogramper milliliter per hour(ng*h/mL)||95% Confidence Interval|Geometric Mean
46505|NCT01366521|Primary|Number of Participants Who Achieved >=50% Eosinophil Repletion by Day 140|This summarizes the number of participants who returned to at least 50% of their Baseline blood eosinophil levels after maximum inhibition had been achieved and without any subsequent decrease in blood eosinophil levels. Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population||Participants|||Number
46506|NCT01366521|Primary|Time to Maximum Change in Blood Eosinophils Levels (Tmaxeos)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the time to first occurrence of maximum reduction from baseline in blood eosinophil levels between Day 1 pre-dose and last quantifiable study measurement.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population.||Days||95% Confidence Interval|Mean
46507|NCT01366521|Primary|Maximum Change From Baseline in Blood Eosinophils (Emax)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the maximum reduction from Baseline in blood eosinophils between Day 1 pre-dose and last quantifiable study measurement. Change from Baseline was calculated as the ratio of the post-Baseline value divided by the Baseline value. The maximum reduction from Baseline in eosinophils is represented by the minimum ratio to Baseline.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population||Giga units per liter (GI/L)||95% Confidence Interval|Geometric Mean
46508|NCT01366521|Primary|Area Under the Blood Eosinophil Time Curve (AUEC) up to Day 84|Area under the absolute blood eosinophil time curve to Day 84 (AUECeos[0-day 84]) determined using the linear trapezoidal rule for subset of participants with blood eosinophil data to Day 84. Blood samples for the analyses of AUEC(eos) (0-day 84) were collected at Days 1, 3, 7, 28, 56, 70 and 84.|Days 1, 3, 7, 28, 56, 70 and 84|PD Population. Only participants with eosinophil data to Day 84 were analyzed.||Giga unit per liter per day (GI*d/L)||95% Confidence Interval|Geometric Mean
46521|NCT01365910|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
47731|NCT01350232|Secondary|Correction of Hemoglobinopathy|To evaluate the extent of correction of hemoglobinopathy following this reduced intensity transplant.|100 days post infusion through 5 years post infusion||||||
46509|NCT01366521|Primary|Change From Baseline in Blood Eosinophil Levels at Week 12 (Day 84)|Change from Baseline in blood eosinophils was calculated as the post-Baseline value minus the Baseline value. The change from Baseline in log-transformed blood eosinophil levels at Week 12 was analyzed using both a linear and non-linear (Imax) dose response models. The dose response was found to be non-linear and hence only the results of the non-linear model are presented. Mepolizumab 75mg IV assumed to equate to 100 mg SC within model. Prior to log10-transformation, zero values were imputed with half the minimum value across all dose groups and time points. An adjustment for Baseline eosinophil count was also incorporated into the model.|Baseline (Day 1 pre-dose) and Week 12|Pharmacodynamic (PD) Population: all participants randomized to treatment and who received at least one dose of study medication and who also had a Baseline PD or biomarker measurement and at least one post-treatment PD or biomarker measurement. Only participants who were available at the specified time point were analyzed.||Proportion of Baseline blood eosinophil||95% Confidence Interval|Number
46510|NCT01366443|Primary|Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus|Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.|1 week|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes who underwent all three assessments.||participants|||Number
46511|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.|10 minutes after treatment|Subjects whose Treatment Day Baseline bacterial counts met qualification criteria||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
46512|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.|30 seconds after treatment|subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments.||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
46513|NCT01366209|Primary|Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52||52 weeks|Intent to Treat all randomized Patient||percentage of patients|||Number
46514|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The ratio between CD4+CD25+FOXP3+ regulatory T cells (Treg) and CD4 conventional T cell (Tcon) counts were measured.|16 weeks of study follow-up|||ratio||Inter-Quartile Range|Median
46515|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The CD4+CD25+FOXP3+ regulatory T cells (Treg) counts were measured.|16 weeks of study follow-up|||cell count/ uL||Inter-Quartile Range|Median
46516|NCT01366092|Secondary|Overall Survival and Progression-free Survival|Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. OS was defined as from the study entry to death from any cause. Patients who were alive or lost to follow-up were censored at the time last seen alive. PFS was defined from the study entry to disease relapse or progression or death from any cause, whichever occurred first.|2 years from start of IL-2|||probability|||Number
46517|NCT01366092|Secondary|Prednisone Taper With IL-2 Therapy|Participants had their steroid dose assessed at weeks 6, 12,16, and every 8 weeks while on extended duration IL-2 therapy.|End of treatment after 16 weeks or most recent follow-up date for patients on extended|Participant's steroid taper was measured using their steroid dose at the start of therapy and their dose at the end of 16 weeks. For participants who continued on extended duration therapy, their final steroid dose was determined at the time of stopping treatment or, if still ongoing, the last clinic visit at the time of data analysis.||percent taper||Full Range|Mean
46518|NCT01366092|Secondary|Toxicity of 12-week Course of Low-dose SC IL-2 Therapy|Participants were evaluated at clinical visits for toxicities related to IL-2 throughout their 12-week treatment course|12 weeks|Grade 2 or higher, related to IL-2, adverse events (AE) were recorded for participants during their 12-week IL-2 treatment course. AE's were evaluated based on the CTCAE version 4.0.||Grade 2 or higher related AEs|||Number
46519|NCT01366092|Primary|Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD|Participants were evaluated according to the cGVHD NIH Consensus criteria at baseline, 6 weeks, and 12 weeks on study. Per cGVHD NIH Consensus criteria, cGVHD involved organ systems are given a grade 0-3 and an overall cGVHD score, from 0-10, is given. Complete Response is defined as resolution of all reversible manifestations in each organ or site of cGVHD. A partial response is defined as an improvement in measure at least one organ or site, or decrease in global ratings by at least a 2-point change on the 10-point scale, without progression measured at any other organ or site. Non-responders have no change in cGVHD meeting criteria for either partial response or disease progression. Progressive disease is defined as an increase in organ or site scales (1-point change on a 3-point scale) or 2- to 3-point increase on the global cGVHD ratings. Clinical worsening of cGVHD is not synonymous with progressive cGVHD per NIH criteria.|Baseline, 6 weeks, and 12 weeks|33 of 35 patients were evaluable for response criteria. To be evaluable, patients had to receive at least 6 weeks of daily IL-2 and had their disease re-assessed.||participants|||Number
46520|NCT01365910|Secondary|Number of Patients With Each Worst‐Grade Toxicity|"Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1= mild; grade 2 = moderate; grade 3 = severe; grade 4 = life‐threatening; grade 5 = death~Assessed: days 1 &15 of cycle 1; day 1 of each subsequent 28-day cycle; at 30-day follow-up for two years"|date on‐study up to 2 years following final dose of study|Total number of patients reported with any toxicity||participants|||Number
46553|NCT01365585|Secondary|Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4|RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
46522|NCT01365910|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring. Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
46523|NCT01365910|Primary|Overall Response Rate (Complete Response + Partial Response) With a Target of at Least 15%|Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Defined as the CR + PR recorded from the start of the treatment until disease progression/recurrence, the exact two-sided 95% confidence intervals will be reported.|Baseline and every 8 weeks, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||percentage of target lesions||95% Confidence Interval|Median
46524|NCT01365845|Secondary|Assessment of Cardiac Function Markers|Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.|after treatment||||||
46525|NCT01365845|Secondary|Assessment of Longterm Side Effects and Disease Specific End Points.|"Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies.~Analyze local control, progression-free survival, and overall survival."|1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.||||||
46526|NCT01365845|Secondary|Assessment of Acute Side Effects|Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.|Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.||||||
46527|NCT01365845|Secondary|Secondary Dosimetric Endpoint|Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.|2 weeks prior to starting radiation therapy.||||||
46528|NCT01365845|Primary|Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)|A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.|2 weeks prior to starting radiation therapy.|||% of heart receiving >= 5 Gray (Gy)||Full Range|Median
46529|NCT01364558|Primary|Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations.|"To calculate bioavailability we used the following formula:~Area Under the Curve (Intranasal Spray)*100/Area Under the Curve (Intravenous Injection)"|2 days|||Percentage of Bioavailability||90% Confidence Interval|Geometric Mean
46530|NCT01365650|Primary|MRT (the Mean Residence Time)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||hours||Standard Deviation|Mean
46531|NCT01365650|Primary|t1/2z (the Terminal Half-life, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||hours||Standard Deviation|Mean
46532|NCT01365650|Primary|AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||ng*h/mL||Standard Deviation|Mean
46533|NCT01365650|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||ng*h/mL||Standard Deviation|Mean
46534|NCT01365650|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||hours||Full Range|Median
46535|NCT01365650|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine|||ng/mL||Standard Deviation|Mean
46536|NCT01365624|Primary|MRT (Mean Residence Time)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.||hours||Standard Deviation|Mean
46537|NCT01365624|Primary|t1/2z (Terminal Half-life)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.||hours||Standard Deviation|Mean
46538|NCT01365624|Primary|AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.||ng*hours/mL||Standard Deviation|Mean
46539|NCT01365624|Primary|AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|||ng*hours/mL||Standard Deviation|Mean
46540|NCT01365624|Primary|Tmax (Time to Reach Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|||hours||Full Range|Median
46541|NCT01365624|Primary|Cmax (Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
46542|NCT01365611|Primary|MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.||hours||Standard Deviation|Mean
46543|NCT01365611|Primary|t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.||hours||Standard Deviation|Mean
46544|NCT01365611|Primary|AUC Inf (the AUC From Time Zero to Infinity, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.||ng*hours/mL||Standard Deviation|Mean
46545|NCT01365611|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine).||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|||ng*hours/mL||Standard Deviation|Mean
46546|NCT01365611|Primary|Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|||hours||Full Range|Median
46547|NCT01365611|Primary|Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|||ng/mL||Standard Deviation|Mean
46548|NCT01365585|Secondary|Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4|Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
46549|NCT01365585|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4|PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
46550|NCT01365585|Secondary|Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4|CI: calculated as COsys divided by BSA.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
46551|NCT01365585|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4|PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
46552|NCT01365585|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4|mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.|||||
46554|NCT01365585|Secondary|Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4|NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. Here, 'n' included those participants who were evaluable for this measure at specified time points.||participants|||Number
46555|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
46556|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 3|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
46557|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 2|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
46558|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 1|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||meter||Standard Deviation|Mean
46559|NCT01365546|Secondary|Post-operative Efficacy Assessment|Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration|up to 30 days|||participants|||Number
46560|NCT01365546|Secondary|Assessment of Intra-operative Hemostatic Efficacy|The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy.|1 Day|||participants|||Number
46561|NCT01365546|Primary|Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale.|Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results (‘secondary adjudication’) and adjudicated the surgeons’/investigators’ assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments (‘primary adjudication’). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures).|30 Days|||participants||95% Confidence Interval|Number
46562|NCT01365507|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
46563|NCT01365507|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
46564|NCT01365507|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Events/100 years of patient exposure|||Number
47732|NCT01350232|Secondary|Acute Graft Versus Host Disease|To describe the incidence and severity of acute and chronic GVHD following this reduced intensity transplant from partially matched related donors using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|100 days post infusion||||||
46565|NCT01365507|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects baseline values were missing, hence not included in the analysis.||mmol/L||Standard Deviation|Mean
46566|NCT01365507|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
46567|NCT01365494|Secondary|Percentages of Subjects Reporting Adverse Events (AEs)|Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.|All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period|Safety population- All subjects in the Exposed population who provide post vaccination safety data and as vaccinated (as treated)||percentages of subjects|||Number
46568|NCT01365494|Secondary|Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations|Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules|Day 0, Day 7, Day 14 and Day 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized||IU\ml||95% Confidence Interval|Geometric Mean
46569|NCT01365494|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42|Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Study day 7, 14 and 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized||Percentages of Subjects|||Number
46570|NCT01365494|Primary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule|On Day 0 and Day 14|Per Protocol Set-All subjects in the FAS (Full analysis set) population who:correctly receive the vaccine, provide evaluable serum sample at day 14, and have no major protocol violation as defined prior to analysis||IU/mL||95% Confidence Interval|Geometric Mean
46571|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point|Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication.that has Chronic Kidney Disease (CKD)||Percentage of patients|||Number
46572|NCT01365481|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
46573|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point|Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication that has Chronic Kidney Disease (CKD) only||Percentage of patients|||Number
46574|NCT01365481|Secondary|Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height|Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height|End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. This analysis includes only participants with baseline MSSBP or MSDBP or (MSSBP or MSDBP combined) ≥95th percentile for gender, age and height. n analyzed is displayed in left column. This OM did not break up the analysis between CKD and non-CKD patients.||Number of Participants|||Number
46575|NCT01365481|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
46604|NCT01365273|Primary|VAS Score for Pain Before Dressing Removal|"Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = no pain at one end to 100 = most intense pain imagaginable at the other end."|At visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.||units on a scale||Standard Deviation|Median
47733|NCT01350232|Secondary|Overall Survival|To determine the overall survival at 6 months post-transplant in patients receiving a matched or partially-matched related donor transplant after reduced-intensity conditioning.|6 months post infusion||||||
46576|NCT01365468|Other Pre-specified|Physician’s Global Assessment of Clinical Condition (PGA) of Skin Lesions|The Physician‟s Global Assessment of Clinical Condition (PGA) is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the patient‟s skin disease as compared to baseline. Responses must be confirmed by at least two assessments separated in time by at least 4 weeks. The grading ranges from 0 to 6; 0 is Completely clear where as 6 is for worse condition. A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement.|Screening, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.|||||
46577|NCT01365468|Other Pre-specified|Number of Patients With Clinical Response|Clinical response is defined as improvement of function, performance status, or decrease in PN related pain persisting for at least 28 days on treatment.|Screening, Day 1, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.|||||
46578|NCT01365468|Primary|Number of Patients With Adverse Events Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) V.04|Adverse events were assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to grades 1 - 4 respectively, were used. CTCAE grade 5 (death) was not used in this study.|From the time ICF was signed until 28 days after End of Treatment (up to a maximum of 25 months)|The Safety Population consisted of all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.||Patients|||Number
46579|NCT01365468|Primary|Number of Patients With Objective Radiographic Responses Based on Volumetric MRI Measurements (In Stratum 2 Only)|"Response was assessed at the time that a follow up volumetric MRI scan is performed (after course 6 and then every 6 months and at the end of treatment).~Complete response (CR): complete resolution of all measurable or palpable PN for ≥ 28days and no appearance of new lesions.~Partial response (PR): A ≥ 20% reduction in the sum of the volume of all index PN lesions for ≥ 28days.~Stable disease (SD): A ‹ 20% increase and ‹ 20% decrease in the sum of the volume of all index PN lesions for ≥ 28days."|Screening, after course #6, then every 6 months and end of treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.||Patients|||Number
46580|NCT01365468|Primary|Time to Disease Progression (TTP) Based on Change in Volumetric MRI Measurements in Children and Adults (In Stratum I Only)|This endpoint was planned to be analyzed for only Stratum 1 patients. Progression of disease defined as a ≥ 20% increase in the volume (by volumetric MRI) of at least one of the index plexiform neurofibromas (PN) compared to the pretreatment volume measured prior to the start of the current treatment phase.|Screening, after course #6, #12, #18, #24, End of Treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.||Days||95% Confidence Interval|Median
46581|NCT01365455|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant’s ability to respond to secukinumab treatment.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||participants|||Number
46582|NCT01365455|Secondary|Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy|PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)& severity is estimated by clinical signs, erythema,induration & desquamation;scale 0(none) to 4(max). Final PASI=sum of severity parameters for each area* area score weight of section(head:0.1,arms:0.2 body:0.3 legs:0.4).PASI 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
46583|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24,36, & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
46605|NCT01365130|Secondary|To Assess the Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.|We will look at the number of patients who have Hematologic Toxicity as well as non-hematologic toxicity|at approx 6, 12 and 18 months||||||
46584|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 4, 8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
46585|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24, 36 & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||95% Confidence Interval|Median
46586|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 4, 8 & 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||95% Confidence Interval|Median
46587|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Week 12, 24, 36, 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||Standard Deviation|Mean
46588|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, Week 4,8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||percent change||Standard Deviation|Mean
46589|NCT01365455|Secondary|Time to PASI 75 Response up to 12 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 was defined as participants achieving ≥ 75% improvement from baseline.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||days||Inter-Quartile Range|Median
46606|NCT01365130|Primary|Number of Patients Without Progression at 3 Months|Response will be assessed via RECIST 1.1 criteria|every three cycles approx every 63 days|||participants|||Number
46607|NCT01365091|Primary|AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area Under the Concentration-time Curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable||ng*h/mL||Standard Deviation|Mean
46590|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
46591|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
46592|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent change||Standard Deviation|Mean
46593|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percent Change||Standard Deviation|Mean
46594|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
46595|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
46608|NCT01365091|Secondary|Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1|All enrolled participants who receive study medication||Participants|||Number
46596|NCT01365455|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. A reduction in score from baseline shows efficacy. Each question has a score of 0 (no symptoms) up to 10 (Severe symptoms)|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Scores on a Scale||Standard Error|Mean
46597|NCT01365455|Secondary|Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||number of participants|||Number
46598|NCT01365455|Secondary|Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||number of participants|||Number
46599|NCT01365455|Secondary|Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 was defined as participants who achievied ≥ 90% improvement from baseline.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
46600|NCT01365455|Primary|Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of Participants|||Number
46601|NCT01365455|Primary|Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.||Percentage of participants|||Number
46602|NCT01365273|Primary|VAS Score for Pain After Dressing Removal|"Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.||units on a scale||Standard Deviation|Median
46603|NCT01365273|Primary|VAS Score for Pain During Dressing Removal|"Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All included subjects to post-randomization treatment and that provided some data for the primary endpoint was included in the Intention To Treat analyses.||units on a scale||Standard Deviation|Median
46609|NCT01365091|Primary|AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area under the concentration-time curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable||pg*h/mL||Standard Deviation|Mean
46610|NCT01365091|Primary|Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets||Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable||μg/mL||Standard Deviation|Mean
46611|NCT01365052|Other Pre-specified|Treatment Compliance - Duration of Exposure to Treatment in Days||10 days after randomization|Safety population||Days||Standard Deviation|Mean
46612|NCT01365052|Other Pre-specified|Treatment Compliance - Number of Capsules Taken||10 days after randomization|Safety population||Capsules||Standard Deviation|Mean
46613|NCT01365052|Primary|Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in AE section|10 days after randomization|Safety population||Percentage of participants|||Number
46614|NCT01365052|Primary|Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in Adverse Events (AE) section|10 days after randomization|Safety population||Percentage of participants|||Number
46615|NCT01365052|Other Pre-specified|Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product||10 days after randomization|Safety population||Percentage of participants|||Number
46616|NCT01365039|Primary|High Contrast, Distance logMAR Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint|4 visits over 3 months|All Eligible, Dispensed Eyes||logMAR|Participants|Standard Deviation|Mean
46617|NCT01365039|Primary|Slit Lamp Findings > Grade 2|Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses|4 visits over 3 months|Over All Follow-up Visits, Eyes with Findings > Grade 2 (All Dispensed Eyes)||eyes|Participants||Number
46618|NCT01364922|Secondary|Participant’s Global Assessment of Study Drug at Final Evaluation|"The participant’s overall impression of the study drug was obtained by having the participant answer the question How would you rate your overall response to the study medication? on a 5-point categorical scale: excellent; very good; good; fair; poor."|Double-blind baseline to Day 29|Double-blind intent to treat population; scores for participants with no post-randomization assessment were excluded from this analysis.||participants|||Number
46619|NCT01364922|Secondary|Participant’s Global Assessment of Back Pain Status at Final Evaluation|"The participant’s overall impression of their back pain status was obtained by having the participant answer the question Considering all the ways your chronic low back pain affects you, how are you doing today? on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)."|Double-blind baseline to Day 29|||participants|||Number
46620|NCT01364922|Primary|Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.|Double-blind baseline to Day 29|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat) and had at least 1 assessment during the double-blind period.||scores on a scale||Standard Error|Least Squares Mean
46621|NCT01364896|Primary|Number of Participants With High-grade Anal Dysplasia Lesions|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months|||participants|||Number
46622|NCT01364896|Primary|Number of Participants Who Had One or More Anal Biopsies|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months|||participants|||Number
46623|NCT01364896|Primary|Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)|High-resolution anoscopy with anal cytology testing|Baseline and 6 to 12 months|||participants|||Number
46624|NCT01364896|Primary|Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58||Baseline and 6 to 12 months|||percentage of participants|||Number
46625|NCT01364896|Primary|Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types|Anal (and vaginal for female participants) HPV PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) using the SYBR-Green-based real-time PCR assay with a reverse line blot assay for genotyping of HPV in the positive samples and Taqman probe-based real-time PCR assays for quantification of individual HPV subtypes|Baseline and 6 to 12 months|||participants|||Number
46626|NCT01364740|Other Pre-specified|Attitude Toward Device Use Questionnaire Scores|Questionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores|one night|||units on a scale||Standard Deviation|Mean
46627|NCT01364740|Secondary|Oxygen Saturation|Mean oxygen saturation|One night|||percent||Standard Deviation|Mean
46628|NCT01364740|Secondary|Hypopnea Index|Number of events/hour of sleep. Hypopneas scored without EEG arousals.|One night|||events/hour||Standard Deviation|Mean
46629|NCT01364740|Secondary|Apnea Index|Number of events/hour of sleep|One night|||events/hour||Standard Deviation|Mean
46630|NCT01364740|Primary|AHI|Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.|One night|||events/hour||Standard Deviation|Mean
46685|NCT01363713|Other Pre-specified|Change in Palpebral Hyperemia Score by Visit|"Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week|||score||Standard Error|Mean
46631|NCT01364649|Secondary|Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved.|Baseline and Weeks 1, 2, 4, 6 and 8|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. Last observation carried forward.||number of participants|||Number
46632|NCT01364649|Secondary|Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline and Weeks 1, 2, 4 and 6|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.||scores on a scale||Standard Error|Least Squares Mean
46633|NCT01364649|Primary|Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.||scores on a scale||Standard Error|Least Squares Mean
46634|NCT01364428|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
46635|NCT01364428|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
46636|NCT01364428|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
46637|NCT01364428|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 22 weeks of treatment.|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 5 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
46638|NCT01364428|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 22 weeks of treatment|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
46639|NCT01364389|Secondary|Effect on Health-related Quality of Life||6 months||||||
46640|NCT01364389|Secondary|Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885||6 months||||||
46641|NCT01364389|Secondary|Pharmacokinetics of AIN457 and ACZ885||Day 15||||||
46642|NCT01364389|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths||6 months|Safety analysis set: This set included all participants who received at least one dose of study medication.||Participants|||Number
46643|NCT01364389|Secondary|Cumulative and/or Mean Steroid Dose Over a 6 Month Period||6 months||||||
46644|NCT01364389|Secondary|Number of Flares Over a 6 Month Period||6 months||||||
46645|NCT01364389|Secondary|Time to First Flare||6 months||||||
46646|NCT01364389|Secondary|Time to Complete Clinical Response|The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: >70% reduction in patient global assessment VAS compared with baseline, morning stiffness < 30 min, CRP < 1.0 mg/dL and/or ESR < 30 mm/1st hr.|Day 15|PD analysis set||Percentage of participants|||Number
46647|NCT01364389|Secondary|Time to Partial Clinical Response|"The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had:~>50% reduction in patient global assessment VAS compared with baseline and morning stiffness < 60 minutes."|Day 15|PD analysis set||Percentage of participants|||Number
46648|NCT01364389|Primary|Polymyalgia Rheumatica Activity Score (PMR-AS)|The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient’s elevation on upper limbs, patient’s assessment of pain, and physician’s global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants.|Baseline, Day 15|Pharmacodynamic (PD) Analysis Set: This set included participants who received at least one dose of study medication and had no major protocol deviation that may impact the PD data.||Percent reduction||Standard Error|Least Squares Mean
46649|NCT01364298|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 7 up to Day 84 (+7 days)|Safety population included all the randomized participants who received at least one dose of study drug.||participants|||Number
46650|NCT01364298|Secondary|Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)|NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.||percentage of participants|||Number
46651|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale|CGIC is an assessment that the physician performs to assess the participant’s global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
46652|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale|GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
46653|NCT01364298|Secondary|Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration|Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12).|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.||participants|||Number
46654|NCT01364298|Secondary|Profile of Mood States (POMS) Score|"POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means not at all and 4 extremely. The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score."|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.||units on a scale||Standard Deviation|Mean
46655|NCT01364298|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84|VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.||centimeter||Standard Deviation|Mean
46665|NCT01363908|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were assessed to determine if a participant was a successful responder and were determined from serum biochemistry analyses conducted at the central laboratories. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||ng/mL||Standard Deviation|Mean
46656|NCT01364298|Secondary|Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84|The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The ﬁrst 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their signiﬁcance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.||units on a scale||Standard Deviation|Mean
46657|NCT01364298|Primary|Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84|An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.||units on a scale||Standard Deviation|Mean
46658|NCT01364207|Primary|Change in Intraocular Pressure at 90 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion~At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.||mm Hg||Standard Deviation|Mean
46659|NCT01364207|Primary|Change in Intraocular Pressure at 60 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion~At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.||mm Hg||Standard Deviation|Mean
46660|NCT01363986|Secondary|Brain Progression-Free Survival (B-PFS)|B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|Due to the premature interruption of the study and the small number of enrolled participants (3 nerolled), all participant data were listed only, without any descriptive statistics or data analysis. The endpoint of B-PFS was thus not analyzed.|||||
46661|NCT01363986|Secondary|Overall Survival|The number of participants surviving at the final visit.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|ITT population; survival status of 1 participant was unknown at the final visit.||participant|||Number
46662|NCT01363986|Secondary|Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit|Brain objective response was defined as either a CR or PR), provided that there was no increase in steroid requirements, or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment|ITT population; 1 participant was not assessed at the final visit.||participant|||Number
46663|NCT01363986|Secondary|Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15|Brain objective response was defined as either a CR or PR, provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)|ITT population; 2 participants were not assessed at Cycle 15.||participants|||Number
46664|NCT01363986|Primary|Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7|Brain objective response was defined as either a complete response (CR) or partial response (PR), provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all central nervous system (CNS) lesions. PR was defined as a greater than or equal to (≥) 30 percent (%) reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])|ITT population; 1 participant was not assessed at Cycle 7.||participants|||Number
47734|NCT01350232|Secondary|Organ Toxicity|To assess organ toxicity related to fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation in a population with severe sickle cell anemia.|30 days post infusion||||||
46666|NCT01363908|Secondary|Change From Baseline in Cardiac Iron Load Assessed by T2* MRI|The efficacy of SPD602 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||milliseconds||Standard Deviation|Mean
46667|NCT01363908|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
46668|NCT01363908|Secondary|Change From Baseline in LIC Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
46669|NCT01363908|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
46670|NCT01363908|Primary|Change From Baseline in Liver Iron Concentration (LIC) Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The Full Analysis Set (FAS), defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.||mg Fe/g*dw||Standard Deviation|Mean
46671|NCT01363908|Primary|Fraction Of Orally Administered Drug Excreted Unchanged In Urine (fe) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||percentage of total dose||Standard Deviation|Mean
46672|NCT01363908|Primary|Amount Excreted Into Urine (Ue) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||mg||Standard Deviation|Mean
46673|NCT01363908|Primary|Renal Clearance (CLr) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||L/h||Standard Deviation|Mean
46674|NCT01363908|Primary|Terminal Half-life (t1/2) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||hours||Standard Deviation|Mean
46684|NCT01363713|Other Pre-specified|Change in Bulbar Conjunctiva Hyperemia Score by Visit|"Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week|||score||Standard Error|Mean
46747|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)|Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||ng/mL|||Number
46675|NCT01363908|Primary|Area Under The Plasma Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||h*mg/L||Standard Deviation|Mean
46676|NCT01363908|Primary|Time of Maximum Observed Plasma Concentration Sampled During a Dosing Interval (Tmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.||hours||Full Range|Median
46677|NCT01363908|Primary|Maximum Observed Plasma Concentration (Cmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The Pharmacokinetic (PK) set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable. The Safety Analysis Set was defined as all participants who had taken at least 1 dose of investigational product. Treatment assignment was based on the treatment actually received.||ng/mL||Standard Deviation|Mean
46678|NCT01363843|Secondary|Evaluate the Toxicity of Study Therapy|"Evaluate the toxicity of induction FOLFOX and subsequent infusional 5-FU or capecitabine/radiation.~•Secondary efficacy measures include the clinical response rate, as measured endorectal ultrasound or pelvic MRI, and incidence and severity of toxicities seen during the various phases of study treatment, including treatment delays, bleeding and post-op complications. Each visit will have a toxicity assessment completed"|approx 1 year||||||
46679|NCT01363843|Primary|Incidence of Complete Resection|The primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine|approx 6 months|||participants|||Number
46680|NCT01363765|Secondary|NRR of Negative-laboratory TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.~Numbers are driven from linkage between lab (all tests done) and notification databases; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.~Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)|||notifications/100,000 persons/year||95% Confidence Interval|Number
46681|NCT01363765|Secondary|NRR of Non-laboratory Tested TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.~Numbers are participants in the notification database who were not in the lab (all tests done) database; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.~Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)|The result is the notification rate ratio||notifications/100,000 persons/year||95% Confidence Interval|Number
46682|NCT01363765|Primary|Costs Per Detected Case|Costs per detected case were analyzed using a decision tree model from the national health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated as (costs with Xpert - costs with smears)/(cases detected with Xpert - cases detected with smears). Negative ICERs mean cost saving.|October 2012 (up to 2 years)|||American dollars|||Number
46683|NCT01363765|Primary|Notification Rate Ratio|Proportion of additional bacteriologically confirmed notified TB cases during intervention period compared to the observation period Patients notified who had a positive test result. The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.|October 2012 (up to 2 years)|Only patients found both in laboratory and in the notification databases were included since this is an outcome based on notification rates. Population growth during time was estimated. NR per 100,000 population||notifications/100,000 persons/year||95% Confidence Interval|Number
47139|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
46686|NCT01363713|Primary|Change in Ocular Itching Score by Visit|"Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week|||score||Standard Error|Mean
46687|NCT01363700|Secondary|Mean Hyperemia Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 7 (5, 10, and 20 minutes post-CAC)|||score||Standard Error|Mean
46688|NCT01363700|Secondary|Mean Ocular Itching Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 7 (3, 5, and 10 minutes post-CAC)|||score||Standard Error|Mean
46689|NCT01363700|Primary|Mean Hyperemia Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 5 (5, 10, and 20 minutes post-CAC)|||score||Standard Error|Mean
46690|NCT01363700|Primary|Mean Ocular Itching Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 5 (3, 5, and 10 minutes post-CAC)|||score||Standard Error|Mean
46691|NCT01363661|Secondary|Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population||Number of events|||Number
46692|NCT01363661|Secondary|Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population||Number of events|||Number
46693|NCT01363661|Secondary|Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).||Month 12|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
46694|NCT01363661|Secondary|Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).|The results are expressed mean relative change (%) between month 6 or month 12, and baseline. A positive result means improvement in the augmentation index between baseline and month 6 or month 12. It could be considered as a surrogate of a decrease of the arterial stiffness. A negative percentage means the inverse. The are no fixed limits to the scale. At month 6,the minimum observed was -139% and the maximum observed was +1600%.At month 12, the minimum observed was -524% and the maximum observed was +1600%.|Month 6 and Month 12|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
46695|NCT01363661|Secondary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).|The results are expressed mean relative change (%) between month 6 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 6. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -200% and the maximum observed was +6100%.|Month 6|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
46696|NCT01363661|Primary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).|The results are expressed mean relative change (%) between month 12 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 12. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -275% and the maximum observed was +4200%.|12 months|Per protocol population||Relative change versus baseline (%)||Standard Deviation|Mean
46697|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter pNN50||Baseline to week 55|||msec||Standard Deviation|Mean
46698|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter rMSSD||Baseline to week 55|||msec||Standard Deviation|Mean
46699|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter SDNN||Baseline to week 55|||msec||Standard Deviation|Mean
46700|NCT01363492|Secondary|Change From Baseline in Urine Gb3||Baseline to week 55|||(nmol/g creatinine)||Standard Deviation|Mean
46701|NCT01363492|Secondary|Change From Baseline in Plasma Gb3||Baseline to week 55|||(nmol/mL)||Standard Deviation|Mean
46702|NCT01363492|Secondary|Change From Baseline in MFS||Baseline to week 55|||(%)||Standard Deviation|Mean
46703|NCT01363492|Secondary|Change From Baseline in LVMI||Baseline to week 55|||(g/m^2.7)||Standard Deviation|Mean
46704|NCT01363492|Primary|Development of IgG Anti-Agalsidase Alfa Antibody|Reflects development of Anti-Agalsidase antibodies post baseline|Baseline to Week 55|||participants|||Number
46705|NCT01363492|Primary|Number of Treatment Emergent Adverse Event (TEAE)||Baseline to week 55|||events|||Number
46706|NCT01363492|Primary|Number of Serious Adverse Event (SAE)||Baseline to week 55|||events|||Number
46707|NCT01363479|Secondary|Proportion of Patients With no Rescue Medication||0-24 hours||||||
46708|NCT01363479|Secondary|Proportion of Patients With no Emesis||0-24 hours||||||
46709|NCT01363479|Primary|Proportion of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication||0-24 hours|Full Analysis Set i.e. patients receiving study drugs and chemotherapy||percentage of responders||95% Confidence Interval|Number
46710|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline and Week 52|||scores on a scale||Standard Error|Least Squares Mean
46711|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline and Week 52|||scores on a scale||Standard Error|Least Squares Mean
46712|NCT01363440|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline and Week 52|||microns||Standard Error|Least Squares Mean
46713|NCT01363440|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline and Week 52|||percentage of participants|||Number
46714|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52|||percentage of participants|||Number
46715|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52|All secondary efficacy endpoints were analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).||percentage of participants|||Number
46716|NCT01363440|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.|Baseline and Week 52|The Primary efficacy endpoint was analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).||letters correctly read||Standard Error|Least Squares Mean
46717|NCT01363401|Secondary|Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)|"The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score presents more severe disability. The higher the score presents less disability.~This was measured at Visit 5 and Visit 9. (week 0,16) The first injection was performed at 0 week.~The score variation between baseline(Visit 5) and 12 weeks following second administration(Visit 9)"|week 0, 16|The SF-36 was assessed except Two participants of no treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.||point||Standard Deviation|Mean
46718|NCT01363401|Secondary|Change in Forced Vital Capacity (FVC) (Percent of Predicted Normal)|"Secondary efficacy was measured by comparing the rate of decline of mean FVC by treatment group.~FVC which is a clinical scale to observe variation in patient’s respiratory competence, was conducted at Visit 1, Visit 5 and Visit 9. (week -12,0,16) The first injection was performed at 0 week. FVC variation between baseline(Visit 5) and 12 weeks following second administration(Visit 9)"|week -12,0,16|"One of the test group, FVC was assessed except because received tracheostomy during the clinical trial.~FVC was assessed except Two participants of no treatment group because 1) ICU admissions for breathing therapy 2) Patients reject the measurement"||percent of prediceted||Standard Deviation|Mean
46719|NCT01363401|Secondary|Change in Appel Scale|"To evaluate the disease change, Appel scale will be assessed. Appel scale is a test tool, which is devised to evaluate the functional condition and variation of ALS(Lou Gehrig’s disease) patients (rating 6~36 for functional condition, 30~164 total).~The higher the total score presents more severe disability. This was done at Visit 1, Visit 5 and Visit 9 (week -12,0,16). The first injection was performed at 0 week Appel scale total score variation between baseline(Visit 5) and 12 weeks following second administration(Visit 9)"|week -12,0,16|Apple scale was assessed except Two participants of No treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.||point||Standard Deviation|Mean
46720|NCT01363401|Primary|The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised (ALSFRS-R) Between Treatment Groups and Control Groups.|ALSFRS-R is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. ALSFRS-R was evaluated at baseline and week 28.(The first injection was performed at 0 week) ALSFRS-R total score variation between baseline(Visit 5) and 12 weeks following second administration(Visit 9)|28 weeks (12-week lead-in period + 16-week treatment and follow-up period)|The ALSFRS-R score was assessed by all the subjects in Phase 1/2 clinical trials.||score on a scale||Standard Deviation|Mean
46721|NCT01363349|Secondary|Long Term Schizophrenia Treatment|Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment|Baseline and 6, 12 and 24 weeks of treatment||||||
46722|NCT01363349|Secondary|Long Term Cognition|Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment|12 and 24 weeks of treatment||||||
46745|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)|Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||ng/mL|||Number
46723|NCT01363349|Primary|Cognition|To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.|Baseline and 6 weeks|Analysis for MCCB Score ITT population.||Scores on a scale||Standard Deviation|Mean
46724|NCT01363076|Primary|MRT (Mean Residence Time)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||hr||Standard Deviation|Mean
46725|NCT01363076|Primary|t1/2 (the Terminal Half-life, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||hr||Standard Deviation|Mean
46726|NCT01363076|Primary|AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng•h/mL||Standard Deviation|Mean
46727|NCT01363076|Primary|AUCinf (the AUC Time From Zero to Infinity, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. AUCinf calculated as: AUCinf = AUC(0-24) + (concentration at 24 hr/elimination constant).|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng•h/mL||Standard Deviation|Mean
46728|NCT01363076|Primary|AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng•h/mL||Standard Deviation|Mean
46729|NCT01363076|Primary|Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. Individual plasma ketorolac concentrations were summarized by dose level for the PK population at each sampling time using n, arithmetic mean, SD, CV(%), geometric mean, 95% confidence intervals (CI) for the arithmetic mean, median, minimum, and maximum.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||hr||Full Range|Median
46730|NCT01363076|Primary|Cmax (the Maximum Observed Plasma Concentration)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose|||ng/mL||Standard Deviation|Mean
46731|NCT01363050|Primary|MRT (the Mean Residence Time|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Standard Deviation|Mean
46732|NCT01363050|Primary|AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng*hours/mL||Standard Deviation|Mean
46746|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)|Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||ng/mL||Standard Deviation|Mean
46733|NCT01363050|Primary|Tmin,ss (the Time to Minimum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Full Range|Median
46734|NCT01363050|Primary|Cmin,ss (the Minimum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng/mL||Standard Deviation|Mean
46735|NCT01363050|Primary|Tmax,ss (the Time to Maximum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Full Range|Median
46736|NCT01363050|Primary|Cmax,ss (the Maximum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng/mL||Standard Deviation|Mean
46737|NCT01363050|Primary|AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng*hours/mL||Standard Deviation|Mean
46738|NCT01363050|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||hours||Full Range|Median
46739|NCT01363050|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.||ng/mL||Standard Deviation|Mean
46740|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)|t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||hours||Inter-Quartile Range|Median
46741|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)|t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||hours|||Number
46742|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)|Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||hours||Inter-Quartile Range|Median
46743|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)|Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||hours|||Number
46744|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)|Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||ng/mL||Standard Deviation|Mean
47140|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
46748|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)|AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.||h*ng/mL||Standard Deviation|Mean
46749|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)|AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)||h*ng/mL|||Number
46750|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)|Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
46751|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)|Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)||percentage of participants|||Number
46752|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 2)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Safety Analysis Set (treatment-experienced only)||percentage of participants|||Number
46753|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug||percentage of participants|||Number
46754|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug||percentage of participants|||Number
46755|NCT01363011|Primary|Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|PK/PD Substudy Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.||mL/min||Inter-Quartile Range|Median
46756|NCT01363011|Primary|Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|Pharmacokinetic/Pharmacodynamic (PK/PD) Substudy Analysis Set (treatment-naive only): participants in the treatment-naive group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.||mL/min|||Number
46757|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46758|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46759|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 1)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)||percentage of participants|||Number
46760|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-experienced participants in the Full Analysis Set with available data were analyzed.||percentage of participants|||Number
46761|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-naive participants in the Full Analysis Set with available data was analyzed.||percentage of participants|||Number
46776|NCT01362946|Secondary|Overall Treatment Recommendation - Parent|At end end of both treatment blocks, parents selected which treatment they though was best for their child - standard behavioral treatment or modified behavioral treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.||percentage of participants|||Number
46762|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46763|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46764|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46765|NCT01363011|Primary|Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46766|NCT01363011|Primary|Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46767|NCT01363011|Primary|Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46768|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46769|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46770|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46771|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min/1.73 m^2||Inter-Quartile Range|Median
46772|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Week 48|Participants in the Safety Analysis Set (treatment-experienced only) with available data were analyzed.||mL/min||Inter-Quartile Range|Median
46773|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.||mL/min||Inter-Quartile Range|Median
46774|NCT01363011|Primary|Change From Baseline in eGFR-CG at Week 24 (Cohort 2)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).|Baseline; Week 24|Safety Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug||mL/min||Inter-Quartile Range|Median
46775|NCT01363011|Primary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).|Baseline; Week 24|Safety Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug||mL/min||Inter-Quartile Range|Median
47141|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
46777|NCT01362946|Secondary|Overall Treatment Recommendation - Counselor|At end end of both treatment blocks, counselors sorted children into one of four treatment response groups: (1) responded best to standard behavior therapy; (2) responded best to modified behavior therapy; (3) responded well to both treatments; (4) did not respond to either treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.||percentage of participants|||Number
46778|NCT01362946|Secondary|Overall Effectiveness|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate how effective this treatment was in changing your child as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (this treatment much less effective) to 4 (this treatment much more effective)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
46779|NCT01362946|Secondary|Overall Satisfaction|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate your overall satisfaction with this treatment as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (much less satisfied with this program) to 4 (much more satisfied with this program)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
46780|NCT01362946|Secondary|Recommend Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you recommend this treatment to other parents?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
46781|NCT01362946|Secondary|Would You Send Your Child to This Treatment Again?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you send your child to this treatment if you could do it over again?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
46782|NCT01362946|Secondary|How Much Did Your Child Enjoy the Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
46783|NCT01362946|Secondary|How Much Did You (the Parent) Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did you benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
46784|NCT01362946|Secondary|How Much Did Your Child Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.||units on a scale||Standard Error|Least Squares Mean
46785|NCT01362946|Secondary|WPRF Overall Problems - Parent|"At the end of each treatment week parents rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46797|NCT01362946|Primary|Positive Peer Behavior|Counselors recorded each instance of positive behavior with peers, defined as helping, sharing and ignoring teasing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of positive peer behave per day||Standard Error|Least Squares Mean
46786|NCT01362946|Secondary|WPRF Overall Problems - Counselor|"At the end of each treatment week counselors rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46787|NCT01362946|Secondary|WPRF Rule Following Problems - Parent|"At the end of each treatment week parents rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46788|NCT01362946|Secondary|WPRF Rule Following Problems - Counselor|"At the end of each treatment week counselors rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46789|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Parent|"At the end of each treatment week parents rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46790|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Counselor|"At the end of each treatment week counselors rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46791|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Parent|"At the end of each treatment week parents rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46792|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Counselor|"At the end of each treatment week counselors rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46793|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Parent|"At the end of each treatment week parents rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46794|NCT01362946|Primary|Minutes of Physical Management|Counselors recorded the total number of minutes children had to be physically managed due to behavior dangerous to themselves or others. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Minutes of Physical Manage per day||Standard Error|Least Squares Mean
46795|NCT01362946|Primary|Number of Time Outs|Counselors recorded the total number of Time Outs children served due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of Time Outs per day||Standard Error|Least Squares Mean
46796|NCT01362946|Primary|Minutes in Time Out|Counselors recorded the total number of minutes children were in Time Out due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Minutes in Time Out per day||Standard Error|Least Squares Mean
46798|NCT01362946|Primary|Rule Violations|Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of rule violations per day||Standard Error|Least Squares Mean
46799|NCT01362946|Primary|Noncompliance|Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of noncompliance per day||Standard Error|Least Squares Mean
46800|NCT01362946|Primary|Interruption|Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of interruptions per day||Standard Error|Least Squares Mean
46801|NCT01362946|Primary|Complaining|Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of complaints per day||Standard Error|Least Squares Mean
46802|NCT01362946|Primary|Negative Verbalizations|Counselors recorded each instance of negative verbalizations, defined as verbal abuse to staff, teasing peers, and swearing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of negative verbals per day||Standard Error|Least Squares Mean
46803|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Counselor|"At the end of each treatment week counselors rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||units on a scale||Standard Error|Least Squares Mean
46804|NCT01362946|Primary|Conduct Problems|Counselors recorded each instance of conduct problems, defined as lying, stealing, intentional destruction of property, and intentional aggression. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).||Number of conduct problems per day||Standard Error|Least Squares Mean
46805|NCT01362907|Secondary|Overall Lens Fit|As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale|Participants|Standard Deviation|Mean
46806|NCT01362907|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale||Standard Deviation|Mean
46807|NCT01362907|Primary|Overall Vision Quality|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale||Standard Deviation|Mean
46808|NCT01362907|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||Units on a scale||Standard Deviation|Mean
46809|NCT01362907|Primary|Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)|As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.||logMAR|Participants|Standard Deviation|Mean
46810|NCT01362894|Secondary|Ease of Selecting Final Lens Power|As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.|Day 0|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
46811|NCT01362894|Primary|Overall Satisfaction|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
47524|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
46812|NCT01362894|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
46813|NCT01362894|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
46814|NCT01362894|Primary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.||Units on a scale||Standard Deviation|Mean
46815|NCT01362530|Secondary|Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
46816|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
46817|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1|Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the acute phase of Cycle 1.|0 to 24 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
46818|NCT01362530|Primary|Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.|25 to 120 hours after the start of chemotherapy|Intent-to-treat (ITT) population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.||Percentage of participants|||Number
46819|NCT01362517|Secondary|Safety: Adverse and Serious Adverse Events|Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection|From Day 1 up to 30 days after the third vaccination|||Number of children with AE per 100 doses|Participants||Number
46820|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 14 months (equivalent to 12 months after the first vaccination|Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up||percentage of subjects||95% Confidence Interval|Number
46821|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 5 months (equivalent to 1 month after the third vaccination)|Analysis population excludes one subject excluded as a protocol violator||percentage of subjects||95% Confidence Interval|Number
46822|NCT01362491|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief|1, 2, & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
46823|NCT01362491|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|1, 2, 3 hours post-dose|ITT population included all randomized patients who received study medication and provided a baseline assessment.||percentage of participants|||Number
46824|NCT01362491|Secondary|Duration of Relief|Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first.|0 to 3 hours|Population included all randomized patients that reported a treatment failure or received rescue medication.|||||
46825|NCT01362491|Secondary|Cumulative Percentage of Participants With First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
47211|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.||mm||Standard Deviation|Mean
46826|NCT01362491|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
46827|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
46828|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
46829|NCT01362491|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
46830|NCT01362491|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
46831|NCT01362491|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
46832|NCT01362491|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
46833|NCT01362491|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
46834|NCT01362491|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
46835|NCT01362491|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
46836|NCT01362491|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0-3 Hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||units on scale||Standard Deviation|Mean
46837|NCT01362439|Secondary|Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores|Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe).|Baseline and Week 13|Safety population included all participants who received atleast one dose of study medication.||units on a scale||Standard Deviation|Mean
46838|NCT01362439|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.|Baseline and Week 13|ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46839|NCT01362439|Secondary|Quality of Sleep Score|This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46840|NCT01362439|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46841|NCT01362439|Secondary|Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.||units on a scale||Full Range|Median
46842|NCT01362439|Secondary|Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13|The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as – 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46843|NCT01362439|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13|The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46844|NCT01362439|Secondary|Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. 'N' (number of participants analyzed) signified participants evaluable for this measure.||percentage of participants|||Number
46845|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46846|NCT01362439|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46847|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.||units on a scale||Standard Deviation|Mean
46848|NCT01362439|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|Intent to Treat Population (ITT) included all participants who received at least 1 dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using Last observation carried forward (LOCF) method.' N' (number of participants analyzed): participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
46849|NCT01362296|Secondary|GSK1120212 Plasma Pharmacokinetic (PK) Concentration|Blood samples for PK analysis of GSK1120212 were collected at the following time points: Cycle 1 (Study Day 15), Cycle 2 (Study Day 22), Cycle 3 (Study Day 43), and Cycle 4 (Study Day 64). Post-dose PK samples collected on Day 15 of Cycle 1 occurred at least 1 hour apart. Participants were instructed to withhold the dose of GSK1120212 until after blood for PK samples had been drawn. Pre-dose samples were taken 15 minutes or less prior to taking the next dose (i.e., trough).|Day 15 of Cycle 1: pre-dose; 0.5-2 hours, 2-4 hours, and 4-8 hours post-dose; Day 1 of Cycle 2, Cycle 3 and Cycle 4: pre-dose|PK Population. Only participants with data available at the specified time points were analyzed.||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
46850|NCT01362296|Secondary|Overall Survival (OS)|OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, OS was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (maximum of 22 months)|MITT Population||Months||95% Confidence Interval|Median
46851|NCT01362296|Secondary|Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase|DOR was assessed by the investigator for participants with CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 mm in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). DOR is defined as the time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause (maximum of 10.2 months)|MITT Population. Only participants who achieved a CR or PR were analyzed for duration of response.||Weeks||95% Confidence Interval|Mean
46852|NCT01362296|Secondary|Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From the date of the first dose of study treatment in the Crossover Phase until the first documented evidence of a CR or PR (maximum of 4 months)|Crossover Population||Participants|||Number
46853|NCT01362296|Secondary|Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From randomization until the first documented evidence of a CR or PR (maximum of 10.2 months)|MITT Population||Participants|||Number
46854|NCT01362296|Secondary|Change From Baseline in Heart Rate: Crossover Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
47642|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours||8-hour intervals from the start of dosing through 48 hours|||mg||Standard Deviation|Mean
46855|NCT01362296|Secondary|Change From Baseline in Heart Rate: Randomized Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
46856|NCT01362296|Secondary|Change From Baseline in SBP and DBP: Crossover Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||mmHg||Standard Deviation|Mean
46857|NCT01362296|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle thereafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
46858|NCT01362296|Secondary|Number of Participants With Any SAE or Non-serious AE: Crossover Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study treatment in the Crossover Phase until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 12 months)|Crossover Population||Participants|||Number
46859|NCT01362296|Secondary|Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From randomization until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 19 months)|Safety Population||Participants|||Number
46860|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, and myelocytes. Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46861|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, myelocytes, neutrophil bands (%). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46886|NCT01362244|Secondary|Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|"Participants were asked to indicate on a VAS (0 to 10 centimeters) the severity of four nasal polyposis symptoms (one VAS for each symptom): rhinorrhea; mucus in the throat; nasal blockage; loss of smell. The left-hand side of the scale (0) represents “not troublesome,” and the right hand side of the scale (10) represents “worst possible troublesome."|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Scores on a scale||Standard Deviation|Mean
46862|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46863|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46864|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46865|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46866|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase|Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3, or Grade 4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population: all participants who, at the point of disease progression during the Randomized Phase, elected to enter the crossover portion of the study. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46875|NCT01362244|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|Blood samples were scheduled to be collected for the assessment of AUC(0-inf) at Weeks 1, 2, 5, 9, 13, and 25 AUC[0-inf] is derived from individual systemic clearance estimates using the expression AUC[0-inf] = Dose/CL. Hence all data are incorporated into the estimation of CL and by implication AUC[0-inf]. The actual time range over which pharmacokinetic data were collected was from time 0 to 336 days post first dose.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Microgram.day per milliliter||Standard Error|Least Squares Mean
46876|NCT01362244|Secondary|Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS)|Blood samples were collected for the assessment of Cmax, Cav(0-inf), and Cmax SS at Weeks 1, 2, 5, 9, 13, and 25. These parameters were estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Micrograms per milliliter||Standard Error|Least Squares Mean
46867|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G, G3, or G4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population: all participants (KRAS, BRAF, NRAS, and MEK1 mutation positive) that received at least one dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. Only participants with data available at the specified time points were analyzed.||Participants|||Number
46868|NCT01362296|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator (INV)|PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. For participants (PAR) who did not have a documented date of PD or DT, PFS was censored at the date of the last adequate assessment. For PAR who received subsequent anti-cancer therapy prior to the date of documented PD or DT, PFS was censored at the date of the last adequate assessment prior to the initiation of therapy.|From randomization (RAN) until the earliest date of documented radiological disease progression (PD) or death (DT) due to any cause (maximum of 10.2 months)|Modified Intent-to-Treat (MITT) Population: all randomized participants with KRAS mutation-positive non-small cell lung cancer (NSCLC), whether or not treatment was administered||Weeks||95% Confidence Interval|Median
46869|NCT01362244|Secondary|Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing)|Blood samples were collected at Weeks 1, 5, 13, and 25 for anti-mepolizumab antibody testing.|Weeks 1, 5, 13, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Participants|||Number
46870|NCT01362244|Secondary|PK/PD Model Derived Maximum Inhibition|Blood samples were collected for the assessment of Maximum Inhibition at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Percentage of inhibition||Standard Error|Least Squares Mean
46871|NCT01362244|Secondary|PK/PD Model Derived Half Maximal Effective Drug Concentration (EC50)|Blood samples were collected for the assessment of PK/PD model derived EC50 at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-partcipant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Microgram per liter||Standard Error|Least Squares Mean
46872|NCT01362244|Secondary|PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual|A residual is the difference between the observed and predicted values. Blood samples were collected for the assessment of PK/PD model derived CV(Baseline), CV(Emax), and residual at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated subjects). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Percentage of variation||Standard Error|Least Squares Mean
46873|NCT01362244|Secondary|Pharmacokinetic/Pharmacodynamic (PK/PD) Model Derived Baseline|Blood samples were collected for the assessment of PK/PD model derived Baseline at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available blood eosinophil count data were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.||Giga units per liter||Standard Error|Least Squares Mean
46874|NCT01362244|Secondary|Half-life (Alpha) and Half-life (Beta)|Half-life (Alpha) is the rate of decline in plasma concentrations due to the process of drug redistribution from the central to the peripheral compartment and half-life (Beta ) is the rate of decline due to the process of drug elimination due to metabolism. Blood samples were collected for the assessment of half-life (Alpha) and half-life (Beta) at Weeks 1, 2, 5, 9, 13, and 25. Half-life was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Days||Standard Error|Least Squares Mean
47643|NCT01351090|Primary|Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours||8-hour intervals from the start of dosing through 24 hours|||mg||Standard Deviation|Mean
46877|NCT01362244|Secondary|Steady-State Volume of Distribution|Steady-state volume of distribution is the blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected for the assessment of steady-state volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. Steady-state volume of distribution was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Liters||Standard Error|Least Squares Mean
46878|NCT01362244|Secondary|Bodyweight-adjusted Clearance|Clearance is the volume of plasma that would contain the amount of drug excreted per day. Blood samples were collected for the assessment of bodyweight-adjusted clearance at Weeks 1, 2, 5, 9, 13, and 25. Clearance was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Liters per day||Standard Error|Least Squares Mean
46879|NCT01362244|Secondary|Volume of Distribution at Weeks 1, 2, 5, 9, 13, and 25|Volume of distribution at steady-state was derived from pharmacokinetic parameter estimates of a population pharmacokinetic model. Blood samples were collected for analysis of volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. All available concentrations at all available datapoints from all participants were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.||Liters||Standard Deviation|Mean
46880|NCT01362244|Secondary|Systemic Clearance at Weeks 1, 2, 5, 9, 13, and 25|Blood samples were collected for the assessment of systemic clearance at Weeks 1, 2, 5, 9, 13, and 25. Systemic Clearance (CL) is estimated using a population-Pharmacokinetic model incorporating all available data points from all subjects. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|Pharmacokinetic (PK) Population: participants in the Safety Population for whom at least one PK sample was obtained and analyzed.||Liters per day||Standard Deviation|Mean
46881|NCT01362244|Secondary|VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The second part of the questionnaire is a VAS question, requiring the participant to self rate his/her health score on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
46882|NCT01362244|Secondary|Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The first part contains descriptions of the following five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses to each of the five domains are measured on a 3-point scale (1-no problems, 2-some problems, and 3-severe problems). An index for the descriptive scores was derived using the general European weights, obtained for each of the countries in this study. Index scores were derived for each participant at each time point. ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
46883|NCT01362244|Secondary|Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline)|"SNOT-22 questionnaire is a modification of the SNOT-20 and contains the questions (ques) related to smell and nasal obstruction. Each ques is graded with a numerical score for each response (res); scores range from 0 for no symptoms to 5 for as bad as things could be. Scores for each of the ques is summed to derive the total score for that par. at that visit. If the par. did not complete any ques at a visit, then he/she were not to have any missing values imputed, and his/her total score for that visit was set to missing. If a par. had some missing scores (but no more than 50% missing at that visit), then scores for the missing resp were imputed as the mean of the non-missing resp for that par. at that visit. The SNOT-22 total score ranges from 0 to 110, with higher scores representing a worse quality of life. Questionnaire data analysis was done using an ANCOVA to obtain the LS-means, treatment difference and confidence interval at Week 25, adjusting for Week 1 Baseline scores."|Week 1 and Week 25|ITT Population||Scores on a scale||Standard Error|Least Squares Mean
46884|NCT01362244|Secondary|Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Sniffin’Sticks were used to assess each participant’s sense of smell (olfaction). Olfaction testing results were recorded for both the right and left nostrils The worst nostril score (number of correct answers for the worst nostril) and the mean nostril score (mean number of correct answers across both nostrils) were recorded. Scores range from 0 to 12 (high score indicating normal olfactory sensation). Olfaction data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
46885|NCT01362244|Secondary|Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Participants used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken, and the largest measurement was recorded in the electronic diary. PNIF data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||L/min||95% Confidence Interval|Least Squares Mean
46900|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ALT, AST, ALP, and GGT were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
46887|NCT01362244|Secondary|Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PEFR is defined as the maximum airflow generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Liters/minute (L/min)||95% Confidence Interval|Least Squares Mean
46888|NCT01362244|Secondary|Mean of Forced Vital Capacity (FVC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|FVC is defined as the maximum amount of air that can forcibly be blown out after a maximum inspiration. FVC was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
46889|NCT01362244|Secondary|Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. FEV1 measurements were taken by spirometry at each clinic visit. FEV1 was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 2, 5, 9, 13, 17, 21, and 25|ITT Population: all randomized participants who received at least one dose of study treatment. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Liters (L)||95% Confidence Interval|Least Squares Mean
46890|NCT01362244|Secondary|Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|Up to Week 25|Safety Population||Participants|||Number
46891|NCT01362244|Secondary|Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks (Wk) 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Results for all urinalysis parameters were assessed for clinical relevance.||participants|||Number
46892|NCT01362244|Secondary|Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Reticulocyte count was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Fraction of 1||Standard Deviation|Mean
46893|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCV was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Femtoliters||Standard Deviation|Mean
46894|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCH was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Picograms (pg)||Standard Deviation|Mean
46895|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|RBC count and RC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||10^12 cells per litre||Standard Deviation|Mean
46896|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Hemoglobin and MCHC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
46897|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Platelet count, WBC count, basophils, eosinophils, lymphocytes, monocytes, and neutrophils were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||10^9 cells per liter||Standard Deviation|Mean
46898|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Total and direct bilirubin, creatinine, and uric acid were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Micromoles per liter||Standard Deviation|Mean
46899|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Albumin and protein were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
47644|NCT01351064|Secondary|Percent of Patients Receiving ADHD Care Component||one year|||percentage of participants|||Number
46901|NCT01362244|Secondary|Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|BUN, glucose fasting, chloride, sodium, potassium, carbon dioxide (CO2), and calcium were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
46902|NCT01362244|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were identified. ECG abnormaility with respect to CS and NCS findings were judged by the investigator or appropriately qualified designee.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Participants|||Number
46903|NCT01362244|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25|Pulse rate was measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||beats per minute||Standard Deviation|Mean
46904|NCT01362244|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 21, and 25|SBP and DBP were measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population: participants who received >=1 dose of study treatment (based on actual treatment received). A participant randomized to mepolizumab took placebo in error. Thus, “N” for the placebo arm of the SP is greater than for the ITT Population. Participants available at the specified time points (represented by n=X, X) were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
46905|NCT01362244|Secondary|Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Assessment of the nasal polyposis condition was performed after 6 months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a VAS. Surgery was required for participants with ENP scores of >=3, or ENP scores of 2 and a VAS symptom score of >7.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population||Participants|||Number
46906|NCT01362244|Secondary|Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Screening and Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Each nostril was assessed for polyps and graded at Screening and at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. The ENP score ranges from 0 (no polyps) to 4, with a higher score indicating a larger polyp. The ENP score was recorded for both the right and the left nostril. The higher of the two scores was derived and used for the analysis.|Screening; Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.||Participants|||Number
46907|NCT01362244|Primary|Number of Participants With a Reduced Need for Surgery at the End of the Study (Week 25)|Assessment of the nasal polyposis condition was performed after six months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a visual analogue scale (VAS). Surgery was still deemed required for a participant with an ENP score of >=3, or an ENP score of 2 and a VAS symptom score of >7. The number of participants with reduced need for polyp surgery are presented as missing data set to non-responders (NR) and missing data last observation carry forward (LOCF). LOCF is defined as missing responses at Week 25 imputed with the last non-missing post-dose observation for that participant.|Week 25|Per Protocol Population: all randomized participants who received at least one dose of study treatment and who complied with the protocol.||Participants|||Number
46908|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|12 weeks (2nd laser treatment)|intent-to-treat||Numeric Pain Rating Score||Standard Deviation|Mean
46909|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment.|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|Day 0 (1st laser treatment)|intent-to-treat||Numeric Pain Rating Score||Standard Deviation|Mean
46910|NCT01362192|Secondary|Percent of Subjects Satisfied With Improvement of Treated Spider Veins.|"Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale:~1 = Very Much Not Satisfied~2 = Not Satisfied~3 = Somewhat Satisfied~4 = Satisfied~5 = Very Much Satisfied"|24 weeks (12 weeks post-final laser treatment)|per protocol||percent of participants|||Number
46911|NCT01362192|Secondary|"Percent of Subjects With Significant to Very Significant Improvement of Lower Extremity Spider Veins, as Assessed by Subject."|"Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol||percent of participants|||Number
46912|NCT01362192|Secondary|"Percent of Subjects With Significant or Very Significant Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator."|"The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol||percent of participants|||Number
47645|NCT01351064|Primary|Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment||one year|||number of kids|||Number
46913|NCT01362192|Secondary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|12 weeks (post-1st laser treatment)|per protocol||points on Improvement scale||95% Confidence Interval|Mean
46914|NCT01362192|Primary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol||points on Improvement scale||95% Confidence Interval|Mean
46915|NCT01362140|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Fatigue|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~Clinically meaningful improvement in fatigue is defined as an increase of ≥ 3 points in the FACIT-Fatigue subscale score, from baseline to EOTP."|Baseline to week 24|FACIT-fatigue analysis set||percentage of participants||95% Confidence Interval|Number
46916|NCT01362140|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) Visual Analog Scale (VAS)|"The EQ-5D visual analog scale (VAS) is a global evaluation of overall health state with scores ranging from 0 (worse health state a participant can imagine) to 100 (best health state a participant can imagine).~End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|The EQ-5D visual analog analysis set includes all participants in the primary analysis set who completed both the baseline and at least 1 subsequent visual analog scale.||units on a scale||Standard Deviation|Mean
46917|NCT01362140|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement. End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|FACIT-Fatigue Analysis Set, includes all participants in the primary analysis set who completed or partially completed both the baseline and at least 1 subsequent FACIT-F questionnaire.||units on a scale||Standard Deviation|Mean
46918|NCT01362140|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa|"Two validated assays were used to detect the presence of anti-darbepoetin alfa antibodies.~Samples were first tested in an immunoassay to detect antibodies capable of binding to darbepoetin alfa. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against darbepoetin alfa. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~The number of participants who developed antibodies to darbepoetin alfa is defined as participants who were neutralizing antibody positive post-baseline with a negative or no result at baseline."|Baseline and end of double-blind treatment period (24 weeks)|Safety analysis set participants with post-baseline antibody results||participants|||Number
46919|NCT01362140|Secondary|Number of Participants With Malignancies Other Than AML, Basal Cell Carcinoma, or Squamous Cell Carcinoma of the Skin||Up to 24 weeks|Safety analysis set||participants|||Number
46920|NCT01362140|Secondary|Number of Participants With Disease Progression to Acute Myeloid Leukemia (AML)|Transformation to AML was assessed according to WHO guidelines in the absence of IP and any haematopoietic growth factors (2 weeks off dosing). Bone marrow and/or cytogenetic report confirmation of AML was required (marrow or peripheral blast cells ≥ 20%, presence of pathognomic AML cytogenetic change, or evidence of marrow blast criteria for erythroleukemia). A pathology report confirming other leukemias such as chloroma (granulocytic sarcoma, myeloid sarcoma) or leukemia cutis also constituted transformation to AML.|24 weeks|Safety analysis set with available data||participants|||Number
46921|NCT01362140|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading scale, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.~Prespecified adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer, included the following categories: hypersensitivity, cardiac failure, hypertension, malignancies, embolic and thrombolic events, venous thromboembolic events (VTEs), central nervous system vascular disorders, and ischemic heart disease."|From first dose of study drug until the end of the double-blind treatment period; 24 weeks.|Safety Analysis Set, including all participants who received at least 1 dose of study drug. One participant in the placebo arm inadvertently received a dose of darbepoetin alfa and is counted in the darbepoetin alfa group for safety analyses.||participants|||Number
46922|NCT01362140|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on International Working Group (IWG) 2006 Criteria in the Double-blind Treatment Period|"International Working Group 2006 erythroid response was defined as achieving an initial ≥ 1.5 g/dL increase in hemoglobin from baseline and sustaining an average rise of ≥ 1.5 g/dL in a rolling 56-consecutive day period in the absence of RBC transfusion.~Participants with no hemoglobin collected to the minimum time required to observe an IWG erythroid response (Week 13) were considered non-responders."|Up to 24 weeks|Primary analysis set participants with a central laboratory baseline hemoglobin value||percentage of participants||95% Confidence Interval|Number
46923|NCT01362140|Primary|Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period||Week 5 to Week 25|Transfusion Primary Analysis Set which includes all randomized and consented participants who received at least 1 dose of study drug and who had an end of treatment period (EOTP) visit ≥ day 29 (ie, start of week 5).||percentage of participants|||Number
46924|NCT01362062|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit|HAQ-DI is a self-completed patient questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The HAQ-DI is the sum of the scores from all domains and ranged from 0 (best) to 24 (worst). A negative change from baseline indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||units on scale||Standard Deviation|Mean
46925|NCT01362062|Secondary|Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit|The participant assessed their pain on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm, and is described as “unbearable pain”. A negative change indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||millimeters||Standard Deviation|Mean
46926|NCT01362062|Secondary|Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as “maximum disease activity” (maximum arthritis disease activity).|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||millimeters||Standard Deviation|Mean
46927|NCT01362062|Secondary|Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as “maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||millimeters||Standard Deviation|Mean
46928|NCT01362062|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
46929|NCT01362062|Secondary|Change From Baseline (CFB) in ESR Values at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||mm/hour||Standard Deviation|Mean
46930|NCT01362062|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit|ACR20/ACR50/ACR70/ACR 90 response: greater than or equal to (≥) 20%/50%/70%/90% improvement in tender and swollen joint counts and 20%/50%/70%/90% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) Participant assessment of disease activity, 3) Participant assessment of pain (VAS), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) ESR at each visit.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 42), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
46931|NCT01362062|Secondary|Time Taken to Achieve Remission (DAS28 <2.6 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment. Time taken to achieve remission is reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||days||Full Range|Mean
46932|NCT01362062|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
50204|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
46933|NCT01362062|Secondary|Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity is defined as decrease in DAS28 to a value <3.2 Units at the time of assessment. Time taken to achieve low disease activity was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||days||Full Range|Mean
46934|NCT01362062|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low Disease Activity is defined as DAS28 value of <3.2 Units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
46935|NCT01362062|Secondary|Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement. Time taken to achieve clinically meaningful improvement in DAS28 was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.||days||Full Range|Mean
46936|NCT01362062|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters [mm]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale [VAS]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*square root (√) of TJC + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population included participants who were observed prospectively in this study. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.||percentage of participants|||Number
46937|NCT01362062|Primary|Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well as non-serious AEs.|Up to 12 months|Safety analysis population: Included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
46938|NCT01361854|Primary|Failure Rate of Sleep Study|"failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as poor or unsatisafctory according to Redline et al. SLEEP 1998 are considered as failed."|1 day|||percentage of participants|||Number
46939|NCT01361633|Secondary|Implicit Memory Task|Assesses implicit memory for anxious and neutral words|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46940|NCT01361633|Secondary|Stroop|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46941|NCT01361633|Secondary|Trails B|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46942|NCT01361633|Secondary|Tower of London|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46943|NCT01361633|Secondary|Wisconsin Card Sort Test|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46944|NCT01361633|Secondary|Logical Memory Subtests|Measures verbal memory recall|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46945|NCT01361633|Secondary|Controlled Oral Word Association Test|Measure of a person's ability to make verbal associations to specified letters.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46946|NCT01361633|Secondary|Continuous Performance Test|Assesses Sustained Attention|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up||||||
46947|NCT01361633|Primary|California Verbal Learning Test-II (CLVT-II)|The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. Software produces a report that computes raw and standardized scores. Our dependent variable was the age adjusted t-score for total number of words recalled after 5 trials. A higher score indicated better recall. The maximum possible score was 80 and a minimum was 0.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without patient follow up. Scores for the experimental and control group were compared.|||age adjusted t-scores||Standard Deviation|Mean
46948|NCT01361620|Primary|Whole Blood Coagulation|Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.|Single measurement at 7-10 days after beginning aspirin|||Aspirin response units (ARU)||Standard Deviation|Mean
46949|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit|within 3 months after discharge||||||
46950|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|Within 3 months after discharge||||||
46951|NCT01361594|Secondary|Surgical Wound Infection|Superficial and deep sternal wound infection|within 3 months after discharge||||||
46952|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).~Congestive heart failure~Cardiac arrhythmias: malignant arrhythmia"|within 3 months after discharge||||||
46953|NCT01361594|Secondary|Measures of Inflammation|Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers|average 1 month during the hospitalization||||||
46954|NCT01361594|Secondary|Incidence of Organ Failures Assessed by the Daily SOFA Score|Incidence of organ failures assessed by the daily SOFA score|average 1 month during the hospitalization||||||
46955|NCT01361594|Secondary|Number of Hospital Readmissions and Emergency Room Visits|Number of hospital readmissions and emergency room visits|Within 30 days after discharge||||||
46956|NCT01361594|Secondary|Thirty Day Mortality|Thirty day mortality|within 30 days of discharge||||||
46957|NCT01361594|Secondary|Duration of Ventilatory Support and ICU Readmission|Duration of ventilatory support and ICU readmission|average 1 month during the hospitalization||||||
46958|NCT01361594|Primary|Hospital Mortality|Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.|average 1 month during the hospitalization|||participants|||Number
46959|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit.|average 1 month during the hospitalization||||||
46960|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|average 1 month during the hospitalization||||||
46961|NCT01361594|Secondary|Surgical Wound Infection|superficial and deep sternal wound infection|average 1 month during the hospitalization||||||
46962|NCT01361594|Secondary|ICU and Hospital Length of Stay, and ICU Readmissions|ICU and hospital length of stay, and ICU readmissions|average 1 month during the hospitalization||||||
46963|NCT01361594|Secondary|Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.|average 1 month during the hospitalization||||||
46964|NCT01361594|Secondary|Acute Renal Failure|new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline|average 1 month during the hospitalization||||||
46965|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).~Congestive heart failure~Cardiac arrhythmias: malignant arrhythmia"|average 1 month during the hospitalization||||||
46966|NCT01361594|Secondary|Glycemic Control|"Hyperglycemic events (BG > 200 mg/dL) in ICU and non-ICU~Hypoglycemic events (BG < 70 mg/dl; severe hypoglycemia (BG < 40 mg/dl)."|average 1 month during the hospitalization||||||
46967|NCT01361594|Primary|Number of Subjects That Were Diagnosed for Peri-operative Complications|Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization|Within 6 months of hospitalization|||participants|||Number
46968|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Vomiting||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.||percentage of patients|||Number
46969|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Nausea||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.||percentage of patients|||Number
46970|NCT01361568|Secondary|Global Evaluation Responder Analysis|"Responders = Excellent or Very Good; Non-Responders = Fair or Poor. Patient who reported a score of Good were not included in the analysis as the midpoint cannot be unambiguously assigned for a binary outcome measurement."|At 24 hours|The responder analysis included all patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.||Responder Count|||Number
52892|NCT01287416|Secondary|Lifetime Suicidal Ideation at Baseline|Number of people who endorsed having thought about suicide in their lifetime as measured at baseline|July 19-20, 2010|||participants|||Number
46971|NCT01361568|Secondary|Total Pain Relief Within the First 2 Hours (TOTPAR 0-2) Following Postoperative Study Drug Treatment Using LOCF|"Patients reported their pain relief using a 5-point categorical scale of 0 to 4 (0 = No Relief, 1 = A Little Relief, 2 = Some Relief, 3 = A Lot of Relief and 4 = Complete Relief). TOTPAR 0-2 was represents the cumulative time-weighted sum of the pain relief (PR) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 15 to 30 min, 30 to 45 min, etc.) over the first 2 hours. Pain relief assessments were measured at 15, 30, 45, 60, 90, 120 minutes after the start of the infusion of study drug following surgery.~Positive TOTPAR values represent an increase in pain relief."|0 to 2 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.||units on a scale * hours||Standard Error|Mean
46972|NCT01361568|Secondary|Morphine Consumption Following Postoperative Study Drug Treatment in the 2-24 Hour Period After Recovery in the Post-Anesthesia Care Unit (Post-PACU)||2 to 24 hours (post-PACU)|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion. Morphine consumption was calculated for the 2-24 hour period, after patients were transferred out of the PACU.||mg||Standard Error|Mean
46973|NCT01361568|Secondary|Summed Pain Intensity Difference From 0-24 Hours (SPID 0-24) Following Postoperative Study Drug Treatment Using Last Observation Carried Forward (LOCF)|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score), then at 15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, 720, 960, and 1440 minutes after the start of the infusion of study drug following surgery.~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.||units on a scale * hours||Standard Error|Mean
46974|NCT01361568|Primary|Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment||24 hours|The primary analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion.||mg||Standard Error|Mean
46975|NCT01361464|Secondary|Number of Participants With Relapse Free Survival|Relapse-free survival is calculated from the date of documentation of complete remission/morphologic complete remission with incomplete blood count recovery (CR/CRi) until disease relapse or death from any cause.|7 months|All evaluable participants||participants|||Number
46976|NCT01361464|Secondary|Median 1-Year Survival Rate|Prior to the early discontinuation of the study (for not meeting the primary endpoint of at least 3 CR/CRi after 2 cycles), investigators had planned to calculate one year survival from Kaplan Meier estimates.|1 year|Evaluable participants at planned study completion date|||||
46977|NCT01361464|Secondary|Median Overall Survival (OS)|Overall survival is calculated from the first day of R115777 treatment and lasts until the date of death recorded on the case report form (CRF).|From first treatment through follow up period, an expected average of 12 months|All evaluable participants||months||95% Confidence Interval|Median
46978|NCT01361464|Primary|Complete Remission (CR) Rate|Complete Remission (CR) rate in Acute Myelogenous Leukemia (AML) patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. AML Complete Remission: Bone marrow aspiration - Less than 5% leukemic blasts, Auer rods not detected; Peripheral blood counts - Absolute neutrophil count >/= 1,000/mm^3, Platelet count >/= 100,000/mm^3, Leukemic blasts not present; Blood-product transfusion independence; Absence of extramedullary leukemia.|From first treatment through follow up period, an expected average of 12 months|All evaluable participants||percentage of participants|||Number
46979|NCT01361308|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity score per day||Standard Deviation|Mean
46980|NCT01361308|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Change from baseline BMI kg/m2||Full Range|Median
47009|NCT01361009|Secondary|Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)|Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).|Baseline (Visit 1) and 12 weeks (Visit 3)|There were 1891 patients in full analysis set(FAS). FAS includes all patients who fulfilled the inclusion criteria and exclusion criteria, without missing PGI values at visit 1 and visit 3. In the recruited 2017 patients, 116 patients didn't fully meet the inclusion or exclusion criteria and 10 patients missed PGI data at visit 1 or visit 3.||unit on a scale||Standard Deviation|Mean
46981|NCT01361308|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject’s total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
46982|NCT01361308|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).~The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.~Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).~Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).~Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.~The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percentage of participants|||Number
46983|NCT01361308|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject’s overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)~The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.~Responders: Subjects Achieving a Score of “Very Much Improved” Or “Much Improved” Or “Minimally Improved”.~Non Responders: Subjects with a Score of “No Change” Or “Minimally Worse” Or “Much Worse” Or “Very Much Worse”."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
46984|NCT01361308|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
46985|NCT01361308|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score|"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.~The sum of the scores for all 5 items was calculated at Week 4 and Week 12. The results presented below are change from baseline at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||units on a scale||Standard Deviation|Mean
46986|NCT01361308|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject’s overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).~The measure being reported below is percentage of responders who had an improvement in NRSscore at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is defined as a score ≤5 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
47010|NCT01361009|Primary|Incidence of AE/SAE|The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.|12 weeks|There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment.||Percentage of participants|||Number
46987|NCT01361308|Secondary|Percentage of Patient Global Improvement (PGI) Scale Responders (%)|"Percentage of PGI Responders: Subject’s overall improvement in VMS from baseline assessed using the Patient Global Improvement (PGI) scale. Responders: Subjects Achieving a Score of “Very Much Better” Or “Much Better” Or “A Little Better”.~Non Responders: Subjects with a Score of “No Change” Or “A Little Worse” Or “Much Worse” Or “Very Much Worse”.~Patient Global Improvement (PGI) scale is described below:~Compared to before starting study medication, how would you describe your hot flushes now? 0 = Not assessed~= Very much better~= Much better~= A little better~= No change~= A little worse~= Much worse~= Very much worse"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
46988|NCT01361308|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
46989|NCT01361308|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||units on a scale||Full Range|Median
46990|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
46991|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
46992|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
46993|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
50205|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
46994|NCT01361308|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.~The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Nightime awakenings||Full Range|Median
46995|NCT01361308|Secondary|Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%)|"A patient improvement scale questionnaire was used during participant visits.~The clinical meaningfulness of the observed treatment effect was demonstrated by performing the following analysis:~Subjects were categorized in to 2 groups (satisfied and unsatisfied). Based on a 7 point patient global impression (PGI) questionnaire which assesses the subject improvement in VMS. Subjects were considered satisfied with their treatment if their response to the question “Compared to before starting the study medication, how would you describe your hot flushes now?” is ‘Very much better’ (1) or ‘Much better’ (2) or ‘A little better’ (3) and will be considered unsatisfied if their response to the same question is ‘No change’ (4) or ‘A little worse’ (5) or ‘Much worse’ (6) or ‘Very much worse’ (7). Receiver Operator Curve (ROC) analysis was performed on the combined data.~Subjects who were satisfied with their treatment were considered to have a treatment effect with clinical meaningfulness"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percentage of satisfied participants|||Number
46996|NCT01361308|Primary|Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.~The results reported are:~Mean Baseline frequency of moderate to severe VMS~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flash per day||Standard Deviation|Mean
46997|NCT01361126|Secondary|Breakthrough Bleeding Events|Number of breakthrough bleeding events (spontaneous bleeding events) requiring treatment per subject in subjects receiving prophylactic treatment regimen with rIX-FP|Week 9 to approximately Week 20|Per protocol population||Events per subject||Standard Deviation|Mean
46998|NCT01361126|Secondary|Clearance of a Single Dose of rIX-FP||Pre-dose and up to 14 days after rIX-FP infusion|PK population||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
46999|NCT01361126|Secondary|Incremental Recovery of rIX-FP at 30 Minutes Following Infusion of rIX-FP|Incremental recovery (IU/mL/IU/kg) is defined as FIX activity (IU/mL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method.|30 minutes after infusion|PK population||IU/dL/IU/kg||Geometric Coefficient of Variation|Geometric Mean
47000|NCT01361126|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP||Pre-dose and up to 14 days after infusion|PK population||hours||Geometric Coefficient of Variation|Geometric Mean
47001|NCT01361126|Secondary|Area Under the Curve to the Last Sample With Quantifiable Drug Concentration (AUC0-t) After a Single Dose of rIX-FP|The plasma concentrations of rIX-FP were measured as FIX activity using a validated, 1-stage assay in a central laboratory for a quantification range from 0.25 to 150% (or 0.25 IU/dL to 150 IU/dL). The PK population comprised all subjects who received at least 1 dose of rIX-FP and for whom a sufficient number of analyzable PK samples had been obtained in order to permit the evaluation of the PK profile of rIX-FP, and who did not receive a dose of rIX-FP or any other FIX product for the treatment of a bleed during the PK sampling period.|Pre-dose and up to 14 days after rIX-FP infusion.|PK population||h*IU/dL||Geometric Coefficient of Variation|Geometric Mean
47002|NCT01361126|Primary|Number of Subjects Who Developed Antibodies to rIX-FP|Antibodies against rIX-FP were detected using a direct binding enzyme-linked immunosorbent assay (ELISA).|Pre-dose, Day 10 and Weeks 4, 12, and 20|Safety Population||participants|||Number
47003|NCT01361126|Primary|Number of Subjects With Inhibitors Against Factor IX (FIX)|The presence of inhibitors against FIX was assessed by the central laboratory by a FIX potency assay. To quantify anti-FIX neutralizing antibodies, the Bethesda assay with the Nijmegen modification was used, and the results expressed as Bethesda Units per mL (BU/mL). A positive inhibitor test is >=0.6 BU/mL.|Baseline, Day 10 and Weeks 4, 12 and 20|Safety Population||participants|||Number
47004|NCT01361126|Primary|Number of Subjects With Treatment-related Adverse Events|The causal relationship of each adverse event to rIX-FP was assessed by the Investigator.|Approximately 20 weeks|Safety Population||participants|||Number
47005|NCT01361048|Secondary|Tolerability of the Study Product|any side effects?|day 12-15 day 30-35||||||
47006|NCT01361048|Primary|Cure of Vaginal Trichmonas|microbiological cure of trichomonas|day 12-15|||percentage of participants|||Number
47007|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at the End of Study|At the end of study, the distribution of patients in 3 pramipexole dosage categories.|12 weeks|There were 2017 patients in SAS set||percentage of patients|||Number
47008|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at Baseline|At enrollment, the distribution of patients in 3 pramipexole dosage categories.|baseline|There were 2017 patients in SAS set.||percentage of patients|||Number
47011|NCT01360840|Other Pre-specified|To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome||From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years|Data for this outcome measure was presented graphically as per planned analysis but not statistically summarized.|||||
47012|NCT01360840|Secondary|Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion|The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"PKA included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."||liter||Standard Deviation|Mean
47013|NCT01360840|Secondary|Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)|The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"Pharmacokinetic Analysis Set (PKA) included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."||Liter per hour||Standard Deviation|Mean
47014|NCT01360840|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.|From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years|The Safety analysis set included all the randomized subjects who received at least 1 dose of planned trial treatment and had at least one safety assessment following the trial treatment.||Subjects|||Number
47015|NCT01360840|Secondary|Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)||Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Percent change||Standard Deviation|Mean
47016|NCT01360840|Secondary|Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)||Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Percent change||Standard Deviation|Mean
47017|NCT01360840|Secondary|Minimum Percentage Change From Baseline in PSA Serum Concentration||Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Percent change||Standard Deviation|Mean
47018|NCT01360840|Secondary|Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response|PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Subjects|||Number
47019|NCT01360840|Secondary|Number of Subjects With Presence of Skeletal Related Events|Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||Subjects|||Number
47020|NCT01360840|Secondary|Bone and Soft Tissue Lesions Composite Tumor Response|Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||Subjects|||Number
47021|NCT01360840|Secondary|Number of Subjects With Presence of DC in Bone Lesions|Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.|At Weeks 13, 19 and 25|ITT analysis set included all the subjects randomized in the study.||Subjects|||Number
47022|NCT01360840|Secondary|Number of Subjects With New Bone Lesions Compared to Baseline|New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.||Subjects|||Number
47032|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
47023|NCT01360840|Secondary|Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions|Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|"ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure."||Subjects|||Number
47024|NCT01360840|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator’s discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||months||95% Confidence Interval|Median
47025|NCT01360840|Secondary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.||months||95% Confidence Interval|Median
47026|NCT01360840|Primary|Progression Free Survival (PFS) Time|PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator’s discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|Intention-to-treat (ITT) analysis set included all the subjects who were randomized in the study.||months||95% Confidence Interval|Median
47027|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
47028|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
47029|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
47030|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
47031|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Percentage of participants|||Number
47078|NCT01360021|Secondary|Peak Expiratory Flow||Recorded morning upon rising and evening before sleep for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||L/Min||Standard Deviation|Mean
47033|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-A Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Error|Least Squares Mean
47034|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Anxiety (HAM-A) Rating Scale Total Score for the Efficacy Sample|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Error|Least Squares Mean
47035|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-D Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.||Units on a scale||Standard Error|Least Squares Mean
47036|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Depression (HAM-D) Rating Scale Total Score for the Efficacy Sample.|The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.|Baseline and Week 14|Efficacy Sample comprised all participants in Safety Sample who had end of Phase A value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The Last-observation-carried-forward (LOCF) data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.||Units on a scale||Standard Error|Least Squares Mean
47037|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Per the Final Protocol.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47038|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47039|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the IDS-SR Total Score for the Efficacy Sample Per the Final Protocol.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.~The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47040|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score for the Efficacy Sample.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.~The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47041|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in CGI-S Scale Score for the Efficacy Sample Per the Final Protocol.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47042|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score for the Efficacy Sample.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47043|NCT01360645|Secondary|Mean CGI-I Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample Per the Final Protocol.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Deviation|Mean
47044|NCT01360645|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.||Units on a scale||Standard Deviation|Mean
47045|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47046|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47047|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in SDS Score for the Efficacy Sample Per the Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47676|NCT01350973|Secondary|Percent Change From Baseline in Triglyceride Level Over Time|The percentage change between triglycerides collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47048|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in Sheehan Disability Scale (SDS) Score for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47049|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47050|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47051|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks, 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Percentage of participants|||Number
47052|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Percentage of participants|||Number
47053|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol|MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13 and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Percentage of participants|||Number
47054|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set|MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Percentage of participants|||Number
47055|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Percentage of participants|||Number
50206|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
47056|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Percentage of participants|||Number
47057|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Deviation|Mean
47058|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set|"The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment.~Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse."|Week 8 to Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Deviation|Mean
47059|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher score indicating worse anxiety symptoms.|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47060|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47061|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52, with higher score indicating more severe depression.|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47062|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52, with higher scores indicating more severe depression.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47063|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol|The IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDSSR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47064|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) IDS-SR Total Score for the Efficacy Sample Set|IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms and atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDS-SR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47065|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47066|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Weeks 8, 9, 10, 11, 12,13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47067|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47068|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47069|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47079|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose|Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Liters||Geometric Coefficient of Variation|Geometric Mean
47142|NCT01358864|Primary|Sustained Virological Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS||percentage of participants||95% Confidence Interval|Number
47070|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47071|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Week 8, 9, 10, 11, 12, and 13|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47072|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Week 8, 9, 10, 11, 12, and 13|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47073|NCT01360632|Primary|Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline and Week 14|Analysis was based on all participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||Units on a scale||Standard Error|Least Squares Mean
47074|NCT01360632|Primary|Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||Units on a scale||Standard Error|Least Squares Mean
47075|NCT01360021|Secondary|Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)|Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.|Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Inhalations/24 hrs||Standard Deviation|Mean
47076|NCT01360021|Secondary|Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)|The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.|Recorded 6:00 – 11:00 AM for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Percentage of days with no awakenings||Standard Deviation|Mean
47077|NCT01360021|Secondary|Asthma Symptoms Score (Total)|The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.|Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Asthma score on a scale of 0 to 3||Standard Deviation|Mean
47080|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Post Dose|Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).||Liter||Geometric Coefficient of Variation|Geometric Mean
47081|NCT01359943|Secondary|Change From Baseline in ESR|Blood for this assessment was obtained to monitor disease activity and response to therapy. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||mm/hr||Standard Error|Least Squares Mean
47082|NCT01359943|Secondary|Change From Baseline in hsCRP|Blood for this assessment was obtained to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||mg/L||Standard Error|Least Squares Mean
47083|NCT01359943|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|The physician’s global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question “Considering all the ways rheumatoid arthritis affects your patient, how would you rate his or her current condition?”. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
47084|NCT01359943|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|"The patient’s global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question Considering all the ways rheumatoid arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are doing today”. A negative change from baseline indicates improvement."|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
47085|NCT01359943|Secondary|Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain|The patient’s assessment of pain was performed using 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (unbearable pain) after the question “Please indicate with a vertical mark through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours”. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
47086|NCT01359943|Secondary|Change From Baseline in Tender 68-joint Count|The 68 joints assessed for tenderness included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Number of joints||Standard Error|Least Squares Mean
47087|NCT01359943|Secondary|Change From Baseline in Swollen 66-joint Count|The 66 joints assessed for swelling included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). A negative change in baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Number of joints||Standard Error|Least Squares Mean
47088|NCT01359943|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response criteria are based on DAS28 status in combination with DAS28 improvements. The EULAR response criteria are as follows: present DAS28 <3.2 with DAS28 improvement >1.2 corresponds to 'good response'; present DAS28 <3.2 with DAS28 improvement between 0.6 to 1.2, or present DAS28 between 3.2 to 5.1 with DAS28 improvement from 0.6 to >1.2, or present DAS28 >5.2 with DAS28 improvement >1.2 correspond to 'moderate response; present DAS28 <3.2 with DAS28 improvement <0.6, or present DAS28 between 3.2 to 5.1 with DAS28 improvement <0.6, or present DAS28 >5.1 with DAS28 improvement <0.6 to 1.2 correspond to 'no response'.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Percentage of participants|||Number
47089|NCT01359943|Secondary|Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), erythrocyte sedimentation rate (ESR), and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-ESR is calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The calculation results in a DAS28-ESR score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
47111|NCT01359449|Secondary|Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.|Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group|28 days post-vaccination|Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.||Titers||95% Confidence Interval|Geometric Mean
47090|NCT01359943|Secondary|Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28-CRP is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-CRP is calculated using the following formula: DAS28-4(crp) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28-CRP score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
47091|NCT01359943|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.|The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.|baseline, 12 Weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||score on a scale||Standard Error|Least Squares Mean
47092|NCT01359943|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Percentage of participants|||Number
47093|NCT01359943|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.||Percentage of participants|||Number
47094|NCT01359904|Secondary|the Number of Infections Related to Vascular Access in Dialysis Among Those Who Receive a Higher Glucose Concentration in the Dialysate and Those Who Receive the Standard Concentration|In the two groups, we will measure the number of episodes of vascular access related infections ie. catheter, AV fistula or AV graft associated infections in the study period. The episode was defined as a diagnosis in the chart written by the nurse or physician with a prescription of antibiotics.|3 months|||episodes|||Number
47095|NCT01359904|Secondary|To Record the Effects of a Higher Dialysate Concentration of Glucose on Glycemic Control of Hemodialysis Patients With Type 2 Diabetes Mellitus by Measuring Serum Levels of Hemoglobin A1c.|Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value. The blood samples were taken prior to dialysis treatments mid-week for each subject at baseline and at the end of the study in both the control and intervention groups.|3 months|||percent||Full Range|Median
47096|NCT01359904|Primary|Hemoglobin A1c Levels|post intervention hemoglobin A1c levels|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.||percent||Full Range|Median
47097|NCT01359904|Secondary|Episodes of Hypoglycemia|record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.||episodes|||Number
47098|NCT01359748|Primary|BP Measurement Using Multifunction KEITO|"Prior starting the measurement phase using Multifunction KEITO, the under test device was reset before each new measurement.~The subject has to be at rest at least 60 seconds before be measured."|30 seconds|||mmHg||Standard Deviation|Mean
47099|NCT01359748|Primary|BP Measurements Using the Reference Auscultatory Sphygmomanometer|"The subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope.~The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures."|Five minutes|||mmHg||Standard Deviation|Mean
47100|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe|AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)|All participants who received at least 1 dose of study drug and entered follow-up period||Participants|||Number
47101|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.|First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)|All participants who received at least 1 dose of study drug.||Participants|||Number
47102|NCT01359644|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24|Change from baseline in log10 HCV RNA at scheduled sampling time.|Baseline, Follow-up week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.||IU/mL||Standard Deviation|Mean
47103|NCT01359644|Secondary|Percentage of Participants Who Experienced Viral Relapse During Follow-up Period|Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.|Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
47104|NCT01359644|Secondary|Percentage of Participants With Viral Breakthrough During the Treatment Period|Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.|First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
47105|NCT01359644|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as participant’s hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here the ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
47106|NCT01359644|Primary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
47107|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination|Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population||Participants|||Number
47108|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.~Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population||Participants|||Number
47109|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.~Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population||Participants|||Number
47110|NCT01359449|Secondary|Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)|Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers < 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate|28 days post-vaccination|Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group||Participants|||Number
47137|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
47112|NCT01359449|Secondary|Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population||Participants|||Number
47113|NCT01359449|Secondary|Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
47114|NCT01359449|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population||Participants|||Number
47115|NCT01359449|Primary|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population||Titers||95% Confidence Interval|Geometric Mean
47116|NCT01359371|Secondary|Estimate the Costs of Implementing the Volunteer Peer Telephone Counseling Including Cost Per Patient and Cost Per Quit.||Collect cost of labor data and number of hours spent by the volunteers providing peer telephone counseling.||||||
47117|NCT01359371|Secondary|Evaluate Satisfaction With Program, Barriers and Facilitators to Implementation and Participating in the Program, and Quality of the Counseling||Interviews with patients, volunteers, and staff; observing volunteer phone calls||||||
47118|NCT01359371|Secondary|Determine if There Were Differences in Quit Rates Between Those That do and do Not Participate in the Peer Telephone Cessation Counseling.||7-day point prevalence quit rate on 60-day survey||||||
47119|NCT01359371|Primary|Determine Differences in the Demographics, Health Characteristics, and Smoking Characteristics of Those Who Were Reached 3-4 Times and Those Who Were Reached 0-2 Times for Peer Telephone Counseling.|Bivariate relationships between number of times a veteran was reached by the volunteer and smoking outcomes as well as other covariates were calculated, using Wald chi-square tests for differences in proportions.|60-day survey - one survey, completed 60 days after discharge|At 60-days after in-patient discharge, seven-day point-prevalence quit rates were higher for those reached 3-4 times.||participants|||Number
47120|NCT01359254|Secondary|Survival at Day 100|Percent of subjects who are alive 100 days after the stem cell infusion|100 days|The only enrolled patient failed to complete the study due to death.|||||
47121|NCT01359254|Primary|Cord Blood Engraftment by Day 100|"Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.~As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient."|100 days|The only enrolled patient failed to complete the study due to death.|||||
47122|NCT01359150|Secondary|Geometric Mean Titer (GMT) of Anti-Influenza Antibody|Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.||titer||95% Confidence Interval|Geometric Mean
47123|NCT01359150|Secondary|Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody|Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.||microgram/milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
47124|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)|GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||fold rise||95% Confidence Interval|Geometric Mean
47138|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS||participants|||Number
47125|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)|Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||fold rise||95% Confidence Interval|Geometric Mean
47126|NCT01359150|Secondary|Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine|Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of >= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
47127|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 3 Influenza Antigens|Response to the influenza vaccine (seroconversion) was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
47128|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens|Response to the pneumococcal vaccine (seroconversion) was defined as >= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
47129|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the influenza vaccine was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
47130|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (End of Study [EOS])|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.||percentage of participants||95% Confidence Interval|Number
47131|NCT01359111|Secondary|Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.|The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day|||percentage of injections|Participants||Number
47132|NCT01359111|Secondary|Proportion of Participants With Safety Events|The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|2 days|||percentage of participants|||Number
47133|NCT01359111|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day|||percentage of injections|Participants||Number
47134|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
47135|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
47136|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS||participants|||Number
47144|NCT01358864|Secondary|Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS||percentage of participants||95% Confidence Interval|Number
47145|NCT01358825|Primary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL|Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
47146|NCT01358825|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period|The analysis was performed on the Total Cohort, which included all subjects enrolled in the study.||Subjects|||Number
47147|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PRP.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (EL.U/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||μg/mL||95% Confidence Interval|Geometric Mean
47148|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).|A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
47149|NCT01358825|Primary|Concentrations of Antibodies Against Anti-HBs.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||mIU/mL||95% Confidence Interval|Geometric Mean
47150|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).|Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
47151|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||EL.U/mL||95% Confidence Interval|Geometric Mean
47152|NCT01358825|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).|Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
47153|NCT01358825|Primary|Concentrations of Antibodies Against Anti-D and Anti-T|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||IU/mL||95% Confidence Interval|Geometric Mean
47154|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.||Subjects|||Number
47155|NCT01358734|Other Pre-specified|Percentage of Participants Alive at One Year|Percentage of participants who survived at one year|Up to 12 months|ITT||Percentage of participants||95% Confidence Interval|Number
47156|NCT01358734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|Up to data cut-off of 01 May 2015; 36 months and 4 days|Safety population includes all participants who have received at least 1 dose of Investigational Product (IP).||participants|||Number
47157|NCT01358734|Secondary|Percentage of Participants With 30-day Treatment-related Mortality|30-day mortality rate is defined as death from any cause within 30 days after first dose.|30 days|ITT includes all randomized participants||percentage of participants|||Number
50207|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
47158|NCT01358734|Secondary|Relapse-Free Survival (RFS)|Relapse-free survival is defined only for participants who achieve a CR or CRi and is measured as the interval from the date of first documented leukemia-free state (defined as less than 5% blasts in an aspirate sample) to the date of leukemia relapse, death from any cause, whichever occurs first, censoring at the last visit date for participants alive in continuous CR or CRi.|Up to 74 months||04/2019||||
47159|NCT01358734|Secondary|Event-Free Survival (EFS)|EFS is defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurs first|Up to 74 months||06/2019||||
47160|NCT01358734|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first observation of documented disease progression or death due to any cause whichever occurs first.|Up to 74 months||04/2019||||
47161|NCT01358734|Secondary|Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)|Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods) AND an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery (CRi) is defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission (PR) is defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if Auer rods are present).|Up to 74 months||04/2019||||
47162|NCT01358734|Secondary|Cytogenetic Complete Remission Rate (CRc)|The CRc response category is comprised of the subset of participants who had abnormal ctyogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment|Up to 74 months||04/2019||||
47163|NCT01358734|Secondary|Duration of Remission (DoR)|Duration of remission defined as the time from the date a response of CR or CRi is first documented until the date the participant has documented relapse after CR or CRi or dies from any cause, whichever occurs first.|Up to 74 months||04/2019||||
47164|NCT01358734|Secondary|Remission Rate (CR + CRi)|Remission Rate was defined as CR + CRi). Morphologic complete remission (CR) was defined as a leukemia-free state defined as less than 5% blasts in a bone marrow aspirate with bone marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods or persistence of extra-medullary disease) AND an absolute neutrophil count (ANC) of > 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and Red Blood Cell transfusion (RBC) independence (no RBC transfusions for 1 week before each assessment). Morphologic complete remission with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC (Absolute Neutrophil Count) may be < 1 x 10^9/L or plateletsmay be < 100 x 10^9/L.|Up to 74 months||04/2019||||
47165|NCT01358734|Primary|Kaplan Meier Estimates for One Year Survival|Overall Survival (OS) was defined as the time from randomization to death from any cause. OS was calculated using the date of randomization and date of death, or date of last follow-up for censored participants.|Up to 24 months|ITT included all randomized participants||months||95% Confidence Interval|Median
47166|NCT01358708|Secondary|Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study|Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study|8 weeks|Analysis conducted on the Intent-to-Treat population for both treatment phases||participants|||Number
47167|NCT01358708|Secondary|Stool Characteristics During the Open-Label Treatment Phase Using the BSFS|The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase ; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind study medication||units on a scale (from 1 to 7)||Standard Deviation|Mean
47168|NCT01358708|Secondary|Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind medication.||units on a scale (from 0 to 500)||Standard Deviation|Mean
47169|NCT01358708|Secondary|Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase|The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome).|At Screening and End of Double-Blind Treatment Phase|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made||units on a scale (from 0 to 42)||Standard Deviation|Mean
47170|NCT01358708|Secondary|Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale|The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.||units on a scale (from 1 ato 7)||Standard Deviation|Mean
47735|NCT01350232|Primary|Stable Engraftment|To determine if the reduced intensity preparative regimen of fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation will generate stable engraftment with donor hematopoietic stem cells in at least 80% of patients with severe sickle cell anemia.|180 days post-infusion||||||
47171|NCT01358708|Secondary|Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.||units on a scale (from 0 to 500)||Standard Deviation|Mean
47172|NCT01358708|Secondary|Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered Yes to the following question at least 50% of the time during the 4-week treatment phase: Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|4 weeks|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; SGA data not available for one patient so that the analysis was performed on 16 rather than 17 patients||percentage of participants|||Number
47173|NCT01358708|Primary|Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered “Yes” to the following question at least 50% of the time during the 4-week treatment phase: “Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|4 weeks|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made||percentage of participants|||Number
47174|NCT01358578|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)|60 weeks|Full Analysis Set||# participants tested positive|||Number
47175|NCT01358578|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set||Units on a scale||Standard Error|Mean
47176|NCT01358578|Secondary|Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set||units on scale||Standard Error|Mean
47177|NCT01358578|Secondary|Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment||52 wks|Full analysis set||participants who reached goal|||Number
47178|NCT01358578|Secondary|Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)||52 wks|Full analysis set||participants who reached goal|||Number
47179|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator’s Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks|FAS||participant acheiving goal|||Number
47180|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS||participant who acheived goal|||Number
47181|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS||participant who acheived goal|||Number
47212|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.||mm||Standard Deviation|Mean
47182|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator’s Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks|||participants acheiving goal|||Number
47183|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|||participants achieving goal|||Number
47184|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the “average pain over the last 24 hours” score for week 12 of the double-blind period.|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||participants (responders)|||Number
47185|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the “average pain over the last 24 hours” score for week 12 of the double-blind period.|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||participants (responders)|||Number
47186|NCT01358526|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test."|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||participants (responders)|||Number
47187|NCT01358526|Secondary|The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12|The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale||95% Confidence Interval|Mean
47188|NCT01358526|Primary|The “Average Pain Over the Last 24 Hours” at Week 12 of the Double-blind Period|The “average pain over the last 24 hours” score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.|24 hours (Week 12)|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale (0 - 10)||Standard Error|Mean
47189|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score|The Q-LES-Q-SF is a 16-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living. The questionnaire was developed and validated for use in depressed outpatient subjects and has eight summary scales that reflect major areas of functioning: physical health, mood, leisure time activities, social relationships, general activities, work, household duties and school/coursework. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The Q-LES-Q-SF percentage maximum possible score is calculated as 100 × (Raw Score – 14 [Minimum Score]) / (70 [Maximum Score] – 14 [Minimum Score]). Higher percent maximum scores indicate better quality of life.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 12 lurasidone + Li/VPA subjects and 11 placebo +Li/VPA subjects did not have post-DB baseline Q-LES-Q-SF percent maximum possible score.||units on a scale||Standard Error|Least Squares Mean
47190|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score|The PIRS-2 is a 2-item self-report of insomnia assessed via a computer interface. Each item is scored from 0-3. The PIRS-2 total score is calculated as the sum of the 2 items. The PIRS total score ranges from 0 to 6. Higher scores are associated with greater severity of insomnia.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline PIRS-2 total score.||units on a scale||Standard Error|Least Squares Mean
47191|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient’s life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on treatment they were randomized. 63 lurasidone + Li/VPA subjects and 57 placebo +Li/VPA subjects did not have post-DB baseline SDS total score.||units on a scale||Standard Error|Least Squares Mean
47192|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 6 lurasidone + Li/VPA subjects and 3 placebo +Li/VPA subjects did not have post-DB baseline PANSS-P score.||units on a scale||Standard Error|Least Squares Mean
47193|NCT01358357|Secondary|Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline QIDS-SR16 total score.||units on a scale||Standard Error|Least Squares Mean
47194|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depressive symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline MADRS total score.||units on a scale||Standard Error|Least Squares Mean
47195|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score|the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline YMRS total score.||units on a scale||Standard Error|Least Squares Mean
47196|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with a greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S depression score.||units on a scale||Standard Error|Least Squares Mean
47197|NCT01358357|Secondary|Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S mania score.||units on a scale||Standard Error|Least Squares Mean
47198|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score|The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1=Normal, not at all ill, to 7=Among the most extremely ill patients. a higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S overall score.||units on a scale||Standard Error|Least Squares Mean
47199|NCT01358357|Secondary|Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||percentage of participants|||Number
47200|NCT01358357|Secondary|Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||Days||95% Confidence Interval|Median
47201|NCT01358357|Secondary|Time to All-cause Discontinuation||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||Days||95% Confidence Interval|Median
47265|NCT01357551|Secondary|Estimated Metabolic Minutes of Walking Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks|||metabolic minutes per week||Standard Deviation|Mean
47266|NCT01357551|Secondary|Estimated Daily Caloric Intake|Based on self-report using Block Brief Food Frequency Questionnaire|56 weeks|||kcal per day||Standard Deviation|Mean
47202|NCT01358357|Primary|Time to Recurrence of Mood Event During the Double Blind Treatment Phase|"A mood event is defined as one of the following during the double-blind phase:~(1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator)."|28 weeks (up to 33 weeks)|ITT (Intent to treat) population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.||Days||95% Confidence Interval|Median
47203|NCT01358175|Secondary|Assessment of Responders for ASAS Partial Remission|ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|16 weeks|||% responders|||Number
47204|NCT01358175|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL|ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.|baseline and 16 weeks|||units on a scale||Standard Error|Least Squares Mean
47205|NCT01358175|Secondary|Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS|SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|baseline, 16 weeks|||units on a scale||Standard Error|Least Squares Mean
47206|NCT01358175|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI|"BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating  worst problem), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 – 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis."|Baseline and 16 weeks|||units on scale||Standard Error|Least Squares Mean
47207|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response|ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|||% responders|||Number
47208|NCT01358175|Secondary|Change From Baseline in Serum hsCRP|The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.|Base line and Week 16|FAS. Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value are from mixed-effect model repeated measures (MMRM) with treatment, visit, TNF-alpha inhibitor status as factors, log(e) baseline and weight as covariates.||ratio||Standard Error|Least Squares Mean
47209|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response|ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.||% responders|||Number
47210|NCT01358175|Primary|Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response|ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.||% responders|||Number
47267|NCT01357551|Primary|Weight||56 weeks post-randomization|||kilograms||Standard Deviation|Mean
47213|NCT01357980|Secondary|Quality of Life (QoL) Total Summary Score|"Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score.~The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0=“Not at all” to 4=“Extremely” for the first 6 items, from 0=“Never” to 4=“Always” for item 7 and from 0=”Always” to 4=”Never” for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated.~Total score has been calculated as the mean of all the items completed among the 8 items.~Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL."|Baseline, 14, 42 and 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.||score on a scale||Standard Deviation|Mean
47214|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.||participants|||Number
47215|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 42|Analysis based on number of subjects in the Intent to Treat (ITT) population.||participants|||Number
47216|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 14|Analysis based on number of subjects in the Intent to Treat (ITT) population.||participants|||Number
47217|NCT01357980|Secondary|Urodynamics:Maximum Detrusor Pressure|Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.||cm water (cm H20)||Standard Deviation|Mean
47218|NCT01357980|Secondary|Urodynamics: Maximum Cystometric Capacity|Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.||mL||Standard Deviation|Mean
47219|NCT01357980|Primary|Daily Incontinence Episode Frequency (IEF)||Baseline and Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.||episodes per day||Standard Deviation|Mean
47220|NCT01357889|Primary|Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase|To assess the bioequivalence of the two formulations of study drug, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter Cmax estimated from the BE phase. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
47221|NCT01357889|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase|To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide Pharmacokinetic (PK) Population: all participants who had sufficient samples to calculate PK parameters of albiglutide. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
47222|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit|ECG parameters include heart rate, QRS interval, QTinterval, QT interval – Bazett correction (QTcB), QT interval – Fridericia correction (QTcF), RR interval, and PR interval. Criteria for values of potential concern were determined by the medical monitors. For the QRS interval, an increase of >25% when Baseline QRS >100 milliseconds (msec) and an increase of >50% when Baseline QRS <=100 msec was considered to be of clinical concern. For QTcF, a >=60 msec change from Baseline was considered to be of clinical concern. For the PR interval, an increase of >25% when Baseline PR >200 msec and an increase of >50% when Baseline PR <=200 msec was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the Safety Population.||Participants|||Number
47268|NCT01357512|Secondary|Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups|Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.|at the end of the study (up to 1 year)||||||
47223|NCT01357889|Secondary|Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17|A complete physical examination was performed at Screening and at Week 17 and included evaluation of the following organ or body systems: skin (including injection site); head; eyes; ears, sose, and throat (ENT); thyroid; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; central nervous system (CNT); and extremities. The assessment was categorized as improved, no change, worsened, and not done.|Screening and Week 17|Safety Population. Only participants analyzed at Week 17 are presented.||Participants|||Number
47224|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit|Vital signs measured included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Criteria for values of potential concern were determined by the medical monitors. For SBP, a decrease or increase >30 millimeters of mercury (mmHg) from Baseline was considered to be of clinical concern. For DBP, a decrease or increase >20 mmHg from Baseline was considered to be of clinical concern. For heart rate, a decrease or increase >30 beats per minute (bpm) was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
47225|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit|Criteria for values of potential concern were determined by the medical monitors. For hematocrit, a >0.1 decrease from Baseline was considered to be of clinical concern. For hemoglobin, a >25 grams per liter (g/L) decrease from Baseline was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
47226|NCT01357889|Secondary|Number of Participants With Indicated Adverse Events of Special Interest|Adverse events of special interest included cardiovascular events, hypoglycemic events, pancreatitis events, thyroid events, gastrointestinal (GI) events, diabetic retinopathy events, systemic allergic reactions (SAR), injection site reactions (ISR), and liver events (AEs from investigations and hepatobiliary disorders were considered).|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study|Safety Population||Participants|||Number
47227|NCT01357889|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Hypoglycemic events are excluded from this table, except for serious adverse events.|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study|Safety Population||Participants|||Number
47228|NCT01357889|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17|This analysis used the LOCF method for missing post-Baseline FPG values. FPG values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on ANCOVA: Change = treatment + Baseline FPG + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF||millimoles per liter||Standard Error|Least Squares Mean
47229|NCT01357889|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This analysis used the last observation carried forward (LOCF) method for missing post-Baseline HbA1c values. HbA1c values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on analysis of covariance (ANCOVA): Change = treatment + Baseline HbA1c + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF: all participants who received a dose of study medication and who had a Baseline measurement and at least 1 post-Baseline HbA1c or fasting plasma glucose (FPG) measurement. Only participants available at the specified time point were analyzed.||Percentage of HbA1c in blood||Standard Error|Least Squares Mean
47230|NCT01357889|Secondary|Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase|The apparent volume of distribution in the terminal phase (V/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||Liters||Geometric Coefficient of Variation|Geometric Mean
47231|NCT01357889|Secondary|Apparent Clearance of Albiglutide in the BE Phase|The apparent clearance (CL/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
47232|NCT01357889|Secondary|t1/2 of Albiglutide in the BE Phase|The terminal elimination half-life (t1/2) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.||Hours||Geometric Coefficient of Variation|Geometric Mean
47233|NCT01357889|Secondary|Cmax of Albiglutide in the BE Phase|Cmax of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
47234|NCT01357889|Secondary|Tmax and Tlag of Albiglutide in the BE Phase|Time of the maximum observed plasma concentration (tmax) and the observed time prior to the first quantifiable plasma concentration (tlag) of albiglutide in the BE Phase were measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or terminal elimination rate constant not estimable were excluded.||Hours||Full Range|Median
47235|NCT01357889|Secondary|AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase|The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of albiglutide in the BE Phase were measured. AUC is a measure of how much albiglutide is in the blood at certain time points. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PK Population.||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
47236|NCT01357889|Secondary|Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase|The presence of anti-albiglutide antibodies after repeat-dose administration was assessed using a qualified enzyme-linked immunosorbent assay. The assay involved screening, confirmation, and titration steps (tiered-testing approach). The number of participants who tested positive for anti-albiglutide antibodies are presented by visit.|Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)|Safety Population: all par. who received at least 1 dose of study medication. Only those par. available at the specified time points were analyzed (represented by n= X, X in the category titles). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Safety Population.||Participants|||Number
47237|NCT01357889|Secondary|Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)|The trough concentration of albiglutide at Week 5, Week 9, Week 13, Week 17 (EOT), and Week 25 (Follow-up) following multiple-dose administration was estimated. The time and date of sample collection pre-dose was to be recorded.|Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)|PK Concentration Population (PKCP): participants (par.) in the MDP for whom a PK sample was collected/analyzed. Only par. available at the specified time points were analyzed (n= X, X in the category titles). Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PKCP.||ng/mL||Standard Deviation|Mean
47238|NCT01357850|Secondary|Number of Participants With Adverse Events by the Indicated Severity|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Severity categories: Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities;Moderate: an event that was sufficiently discomforting to interfere with normal everyday activities; Severe: an event that prevents normal everyday activities.|Baseline and Week 13|All Subjects Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
47239|NCT01357850|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Please refer to the AE/SAE section for further details.|Baseline and Week 13|All Subject Population: all randomized participants who received >= 1 dose of study medication. Only those participants available at the specified time points were analyzed.||Participants|||Number
47240|NCT01357850|Secondary|Change From Baseline in Quality of Life as Assessed by the Minnesota Living With Heart Failure Questionnaire|Minnesota living with heart failure questionnaire (MLHFQ) is a validated instrument to measure participant-reported quality of life at Baseline and Week 13. For each of 21 items, participants rated the effects of heart failure and its treatment on physical, socioeconomic and psychological aspects of their life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each participant to indicate their response using a 6-point scale (ranging from 0 to 5, 0=no, 1=very little, and 5=very much). The min and max scores can range from 0 to 105. The likert scale measures the effect of heart failure and treatments for heart failure on an individual's ability to live as they want. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||95% Confidence Interval|Geometric Mean
47864|NCT01348139|Primary|E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit|Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.|22-26 hrs.|PD analysis set||Liters||Standard Deviation|Mean
47241|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Insulin|Blood samples for biomarker analysis of fasting levels of insulin were collected at Weeks 1, 7 and 13. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||picomole per liter (pmol/L)||Standard Error|Geometric Mean
47242|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Glucose, and Free Fatty Acids (FFA)|Blood samples for biomarker analysis of fasting levels of glucose and FFA were collected at Weeks 1, 7 and 13; glucose was also collected at Weeks 2, 4, 6, 8, 10, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Millimole per liter (mmol/L)||Standard Error|Geometric Mean
47243|NCT01357850|Secondary|Change From Baseline in Serum N-terminal Fragment Brain Natriuretic Peptide (NT-BNP) Level|Baseline is defined as the last available assessment on or prior to the first dose of study medication. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Change from Baseline at Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Nanogram per liter||Standard Error|Geometric Mean
47244|NCT01357850|Secondary|Change From Baseline in Exercise Capacity Assessed by 6-minute Walk Test|The six minute walk test was performed at Baseline and Week 13. All participantss were given standardized instructions and the distance walked was measured. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Meters||95% Confidence Interval|Geometric Mean
47245|NCT01357850|Secondary|Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS)|Change in Baseline in cardiac and liver fat by proton spectroscopy was planned at Baseline and Week 13. The protocol allowed for sites to perform all or only efficacy assessments, depending on site designation, capability and feasibility. No sites that enrolled participants into this study were able to perform this outcome measure.|Baseline and Week 13||||||
47246|NCT01357850|Secondary|Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS)|Participants underwent a CMR scan performed on a 3 Tesla MR system at Baseline and Week 13 to assess cardiac mass, volumes (global function and dilatation), strain and torsion, cardiac and liver lipid content and cardiac energy metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|Magnetic Resonance Substudy Population (MRS): all randomized participants who participated in the MRS substudy and had valid Baseline and/or Week 13 assessments for either PCr/ATP via 31P MRS. Only those participants available at the specified time points were analyzed.||ratio||95% Confidence Interval|Least Squares Mean
47247|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left/right ventricular ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.||Grams||Standard Error|Geometric Mean
47248|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess LV and RV ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.||Milliliters||Standard Error|Geometric Mean
47249|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left ventricular (LV) and right ventricular (RV) ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Only those participants available at the specified time points were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population: all randomized participants who participated in the CMR substudy and had valid Baseline and/or Week 13 assessments for >= 1 one of the imaging parameters of LV and RV function assessed by CMR (LVEF, LV and RV volumes in systole and diastole, LV mass), myocardial strain assessed by myocardial tagging indices.||Percentage||Standard Error|Geometric Mean
47250|NCT01357850|Secondary|Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Milliliters||Standard Error|Geometric Mean
47251|NCT01357850|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave, and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage||Standard Error|Geometric Mean
47269|NCT01357512|Secondary|Number of Positive Biopsies in MRI and no MRI Groups|The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.|at the end of the study (up to 1 year)|||number of cancer-positive biopsy cores||Inter-Quartile Range|Median
47252|NCT01357850|Primary|Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing|Peak VO2 was measured at Baseline and Week 13. Participants performed a maximal exercise test limited by dyspnea or fatigue on a cycle ergometer. After a rest period, the workloads were increased in a step fashion by 25 watts every 3 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||Milliliters per kilogram per minute||95% Confidence Interval|Least Squares Mean
47253|NCT01357850|Primary|Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest|MVO2 was estimated by measuring the rate of myocardial clearance of 11C-activity which represents overall myocardial oxidative flux through the TCA cycle. Cardiac work was measured by echocardiography and cardiac efficiency index was calculated as work (by echocardiography) divided by MVO2. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.||millimeters of mercury/liter/minute2||95% Confidence Interval|Least Squares Mean
47254|NCT01357850|Primary|Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging|FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and had >= 1 on treatment assessment. Only those participants available at the specified time points were analyzed.||micromoles per gram per minute||95% Confidence Interval|Least Squares Mean
47255|NCT01357720|Primary|Seroprotection Rate: Anti-B. Pertussis Antibodies|Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
47256|NCT01357720|Primary|Seroprotection Rate: Anti-tetanus Toxoid Antibodies|Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
47257|NCT01357720|Primary|Seroprotection Rate: Anti-diphtheria Toxoid Antibodies|Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
47258|NCT01357720|Primary|Seroprotection Rate: Anti-hepatitis B Surface Antibodies|Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
47259|NCT01357720|Primary|Seroprotection Rate: Anti-PRP Antibodies|Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4||percentage of subjects||95% Confidence Interval|Number
47260|NCT01357616|Secondary|Mean IOP Change From Baseline (5 PM) at Week 8|Mean IOP change from baseline (5 PM) at Week 8 was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||mmHg||Standard Deviation|Least Squares Mean
47261|NCT01357616|Secondary|Mean IOP Change From Baseline at 11 AM|Mean IOP change from baseline at 11 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||mmHg||Standard Deviation|Least Squares Mean
47262|NCT01357616|Secondary|Mean IOP Change From Baseline at 9 AM|Mean IOP change from baseline at 9 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||mmHg||Standard Deviation|Least Squares Mean
47263|NCT01357616|Primary|Mean Diurnal IOP Change From Baseline at Week 8|Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.||millimeters mercury (mmHg)||Standard Deviation|Least Squares Mean
47264|NCT01357551|Secondary|Estimated Metabolic Minutes of Moderate Physical Activity Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks|||metabolic minutes per week||Standard Deviation|Mean
47865|NCT01348139|Primary|Emax: Maximum Value of FEV1 for Every Treatment Visits|Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.|0-24 hrs|||Liters||Standard Deviation|Mean
47270|NCT01357512|Primary|Number of Prostate Cancer Diagnoses in MRI and no MRI Groups|The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.|at the end of the study (up to 1 year)|||participants|||Number
47271|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum II|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score on a scale||Standard Error|Least Squares Mean
47272|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum I|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score on a scale||Standard Error|Least Squares Mean
47273|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum II|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment||Number of participants|||Number
47274|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum I|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment||Number of participants|||Number
47275|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech, and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum II|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
47276|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum I|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
47277|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum II|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum II included patients whose FMR1 gene was partially methylated|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Participants|||Number
47278|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum I|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Participants|||Number
47279|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum II Patients|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum II included patients whose FMR1 gene was partially methylated|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
47280|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum I Patients|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
47281|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum I Patients Exposed to the Two Lower Doses of AFQ056 (25 mg Bid and 50 mg Bid)|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose FMR1 gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
47282|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum II Patients Exposed to All 3 Doses of AFQ056|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum II included patients whose FMR1 gene was partially methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
47896|NCT01347840|Secondary|Percent Weight Loss|(Weight at Baseline – Weight at Each Visit) divided by the (Weight at Baseline).|16 Months|||percentage of weight loss|||Number
47283|NCT01357239|Primary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the Aberrant Behavior Checklist–Community Edition (ABC-CFX) Total Score in Stratum I Patients Exposed to AFQ056 100 mg Bid|The Aberrant Behavior Checklist-Community edition (ABC-C) is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose Fragile X Mental Retardation 1 (FMR1) gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included||Score||Standard Error|Least Squares Mean
47284|NCT01357148|Primary|Number of Participants Taking Concomitant Medications||Up to approximately 28 months|||participants|||Number
47285|NCT01357148|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months|||participants|||Number
47286|NCT01357148|Primary|Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl||Up to approximately 28 months|||years||Standard Deviation|Mean
47287|NCT01357148|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months|||participants|||Number
47288|NCT01357135|Primary|Percentage of Participants With Strict Changes in Initial Dual Therapy|Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.|Up to 3 years|All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.||Percentage of Participants|||Number
47289|NCT01357135|Primary|Median Duration (in Months) of Initial Dual Therapy|The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.|Up to 3 years|All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.||months||95% Confidence Interval|Median
47290|NCT01356966|Secondary|Change in Heart-rate-corrected Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows: HR-corrected AIx = -0.39 x (75 - HR) + AIx. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks|||percent||Standard Error|Mean
47291|NCT01356966|Secondary|Change in Mean Central Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks|||percent||Standard Error|Mean
47292|NCT01356966|Primary|Change in Resting Muscle Sympathetic Nerve Activity (MSNA)||Baseline, 12 weeks|Two subjects withdrawn from each arm due to adverse events. Additionally, two subjects from the treatment group and one subject from the placebo group were not included in this analysis because an adequate MSNA neurogram was unable to be obtained at the end of the study.||bursts/minute||Standard Error|Mean
47293|NCT01356940|Secondary|Stepcount|daily stepcount recorded by an accelerometer and averaged over 1 week of wear|10 weeks||||||
47294|NCT01356940|Primary|Peak Activity Index|peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention|10 weeks|||change in strides per minute||Standard Deviation|Mean
47295|NCT01356667|Secondary|Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.|The Addiction Severity Index, Native American Version will be utilized to assess problem severity in alcohol use, drug use, employment, family and social relationships, legal, psychological, and medical status. In addition, additional information with regards to mental health characteristics will be obtained from the Brief Symptom Inventory.|Change from Baseline in Mental Health and psychosocial characteristics at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.|||||
47296|NCT01356667|Secondary|Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension|The General Alcoholics Anonymous Tools of Recovery (GAATOR 2.1) will be provided in order to determine and track patient's knowledge of the 12-steps during their participation in the DARTNA treatment program.|Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.|||||
47297|NCT01356667|Primary|Drug and Alcohol Use as a Measure of Treatment Effectiveness|Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.|Change from Baseline in Drug and Alcohol use at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.|||||
47298|NCT01356602|Secondary|C-reactive Protein Level|A central laboratory was used for analysis of all blood samples collected.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||mg / L||95% Confidence Interval|Least Squares Mean
47299|NCT01356602|Secondary|Amount of Rescue Medication Taken (mg)|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||milligrams (mg)||Standard Deviation|Mean
47300|NCT01356602|Secondary|Time to First Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Hours||Full Range|Median
47301|NCT01356602|Secondary|Proportion of Patients With Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Particpants|||Number
47302|NCT01356602|Secondary|Physician's Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
47303|NCT01356602|Secondary|Physician's Assessment of Erythema|The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
47304|NCT01356602|Secondary|Physician's Assessment of Swelling|The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Partipants|||Number
47305|NCT01356602|Secondary|Physician's Assessment of Tenderness|The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that “there is pain”, 2 = patient states “there is pain and winces” and 3 = patient states “there is pain, winces and withdraws” on palpation or passive movement of the affected study joint.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
47306|NCT01356602|Secondary|Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
47307|NCT01356602|Secondary|Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
47308|NCT01356602|Secondary|Time to Resolution of Gouty Arthritis Flare as Reported by Patient|Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Hours||95% Confidence Interval|Median
47309|NCT01356602|Secondary|Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Hours||95% Confidence Interval|Median
47310|NCT01356602|Secondary|Time to the First New Gouty Arthritis Flare|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Days||95% Confidence Interval|Median
47311|NCT01356602|Secondary|Number of Patients With at Least One New Gouty Arthritis Flare After Baseline|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Particpants|||Number
47312|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of Patients|||Number
47313|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 0-100mm VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Millimeters||Standard Error|Least Squares Mean
47314|NCT01356602|Secondary|Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Millimeters||Standard Error|Least Squares Mean
47315|NCT01356602|Primary|Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Millimeters||Standard Error|Least Squares Mean
47316|NCT01356589|Secondary|Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants. 'N' (number of participants analyzed) included those participants who were evaluable for this outcome measure.||percentage of participants|||Number
47317|NCT01356589|Secondary|Number of Full Hemoglobin Cycles Per Participant|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants.||cycles||Standard Deviation|Mean
47318|NCT01356589|Primary|Percentage of Participants With at Least One Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.|9 months|Analysis population included all treated participants.||percentage of participants|||Number
47319|NCT01356498|Secondary|Gout Flare Incidence|Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.|Assessed in 3-month intervals up to 2 years|The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.||Percentage of participants|||Number
47320|NCT01356498|Secondary|Gout Flare Frequency|The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment|Up to 2 years|Analysis is based on ITT population, and is presented by intervals of time on pegloticase||Flares||Standard Deviation|Mean
47321|NCT01356498|Secondary|Patient Reported Outcome: SF-36 Physical Component Summary Score|"SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best).~The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status."|RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101|Number of participants was the subset of the ITT population with SF-36 baseline data||units on a scale||Standard Deviation|Mean
47322|NCT01356498|Secondary|Tophus Response|Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.|Up to 2 years|ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.||participants|||Number
47323|NCT01356498|Primary|Uric Acid (mg/dL)|Uric acid measured at 3 month-intervals|Week 13, Week 25, Week 53, Week 101|ITT||mg/dL||Standard Deviation|Mean
47324|NCT01356407|Secondary|Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation|The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||participants|||Number
47325|NCT01356407|Secondary|Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)|At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality “adequate for clinical diagnostic purposes” (Y/N). The total Ottawa Scale scores was correlated with ‘adequate’ or ‘inadequate’ quality of bowel preparation for clinical diagnostic purposes|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||units on a scale||Standard Deviation|Mean
47326|NCT01356407|Secondary|Percentage of Successful Completion of Colonoscopy|An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||Percentage of Subjects (%)|||Number
47327|NCT01356407|Secondary|Ottawa Scale Score by Colon Segment|Mean Ottawa Scale scores, and score categories (from 'excellent’ to ‘bad’), are summarised by colon segment together with the overall fluid content score|Day 2|All randomized patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||units on a scale||Standard Deviation|Mean
47328|NCT01356407|Secondary|Patient Response to Acceptability and Tolerability Questionnaire|On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set||units on a scale||Standard Deviation|Mean
47329|NCT01356407|Primary|The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation|The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 (‘excellent’ visibility) to 4 (‘inadequate’ visibility); The component scores for each of the colon segment are added together, along with an overall ‘fluid’ score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)|day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.||units on a scale||Standard Deviation|Mean
47330|NCT01356147|Secondary|Number of Days on Ventilator Support||7 days||||||
47331|NCT01356147|Secondary|Reduction in White Blood Cell Count and Bacterial Load From Tracheal Aspirate||During first week of treatment or until extubation whichever is earlier||||||
47332|NCT01356147|Primary|Percent Reduction in Oxygen Requirement From Baseline|Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation|First week of treatment or extubation|||percentage FiO2||Full Range|Mean
47333|NCT01355978|Secondary|Safety and Device-related Adverse Events|Any adverse events reported during he study period.|Continuous from Study Day 2 through Study Day 6|||participants|||Number
47334|NCT01355978|Secondary|Device Preference|"5-point Likert Scale completed at the end or the 5-day study period~- Preference Scale: 5 = Max preference (Prefer to use the test device), 1 = Min preference (Do not prefer to use the test device)"|At conclusion of subject's participation (up to two weeks)|||units on a scale||Full Range|Median
47335|NCT01355978|Primary|Device Tidal Volume|Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).|Periodically over six hours x 5 days|||mL||Standard Deviation|Mean
47336|NCT01355679|Secondary|Activity of Treatments Chosen Based on Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year|||Days||95% Confidence Interval|Mean
47337|NCT01355679|Secondary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|||percentage of participants with PR or CR|||Number
47338|NCT01355679|Secondary|Number of Participants With Adverse Events as a Measure of Safety|To determine the safety of allowing a molecular tumor board to determine individualized treatment plans|1 year|||participants|||Number
47897|NCT01347840|Secondary|Body Mass Index|Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.|16 Months|||units on a scale|||Number
47339|NCT01355679|Primary|Percentage of Participants That Are Able to Meet Feasibility Parameters.|Feasibility parameter defined as: Enrollment onto study, quality mRNA obtained, gene chip completed, tumor board held, medical monitor review and approval, start of treatment by 21 days post biopsy/surgical resection date, and then completion of 1 cycle of therapy.”|1 year|All subjects had soft tissue disease in which biopsy was possible. Two subjects were deemed ineligible due to benign tumor type after biopsy.||percentage of participants|||Number
47340|NCT01355627|Secondary|Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele|Non-clinically evident pseudomeningocele was defined as a cerebrospinal fluid accumulation found on a postoperative computerized tomography (CT) or magnetic resonance imaging (MRI) scan which fulfilled the following criteria according to the radiologist assessment before Day of Discharge: CT Scan-Fluid accumulation seen as Hypodense signal, MRI Scan-Fluid accumulation seen as Hypointense signal in T1-weighted image and/ OR Fluid accumulation seen as Hyperintense signal in T2-weighted image.|Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks)|Full Analysis Population included all enrolled randomized patients.||percentage of participants||95% Confidence Interval|Number
47341|NCT01355627|Primary|Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure|An assessment was performed daily from randomization to Day of Discharge and at the Efficacy Follow-up visit at week 7 ± 1 week. Clinically evident cerebrospinal fluid leak was confirmed by: 1. Glucose concentration test and/or 2. β-2-transferrin test. A clinically evident pseudomeningocele was considered to be present post-operatively if the following criteria were fulfilled: 1. A subcutaneous, visible/palpable fluctuant fluid accumulation was noted at the site of the surgical incision or adjacent to it; 2. It is suspected the fluid accumulation is cerebrospinal fluid. A treatment failure was defined as application of a new and/or different treatment after application of the study treatment or a third application of (or part of) the selected study treatment on the outside of the dura.|Up to 8 Weeks (7 Weeks ± 1 Week)|Full Analysis Population included all enrolled randomized patients.||percentage of participants||95% Confidence Interval|Number
47342|NCT01355588|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||hours||Full Range|Median
47343|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||ng*h/mL||Standard Deviation|Mean
47344|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||ng*h/mL||Standard Deviation|Mean
47345|NCT01355588|Primary|Maximum Observed Plasma Concentration (Cmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose|||ng/mL||Standard Deviation|Mean
47346|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 10 Weeks Postoperatively|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.~Units of measure = % of patients with YES to POCD"|App. 10 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 10 weeks postoperatively.||Percentage of patients|||Number
47347|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 2 Weeks Postoperatively.|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.~Units of measure = % of patients with YES to POCD"|App. 2 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 2 weeks postoperatively.||Percentage of patients|||Number
47348|NCT01355523|Secondary|HPER3 Genotype|A blood sample will be taken at inclusion and analysed for HPER3 genotype (4/4, 4/5, 5/5) and this will be investigated for a correlation with sleep, cognitive function and depressive symptoms 7 patients did not give blood samples|At inclusion = day-7|||Participants|||Number
47349|NCT01355523|Secondary|Sleep Architecture|Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph will be worn from inclusion till 14 days postoperatively.|From inclusion till 14 days postoperatively||||||
47397|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Directly Related to NRTI|incidence of elevated venous lactate levels more than 2 mmol/L directly related to NRTI until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
47350|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Long-term Postoperative Period|"Subjective sleep on a Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
47351|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Immediate Postoperative Period|"Subjective sleep score on Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
47352|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Long-term Postoperative Period|"Pain on a Visual Analog Scale - filled out every 14th day. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
47353|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Immediate Postoperative Period|"Pain on a Visual Analog Scale - filled out daily. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
47354|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on General Well-being - Long-term Postoperative Period|"General well-being on a Visual Analog Scale - filled out every 14th day. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
47355|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on General Well-being - Immediate Postoperative Period|"General well-being on a Visual Analog Scale - filled out daily. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|Patients were only included in the analysis if they had completed daily VAS on anxiety for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward.||mm*day||Inter-Quartile Range|Median
47356|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Long-term Postoperative Period|"Fatigue on a Visual Analog Scale - filled out every 14th day. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||mm*2 weeks||Inter-Quartile Range|Median
47357|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Immediate Postoperative Period|"Fatigue on a Visual Analog Scale - filled out daily. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
47358|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Long-term Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|||Units on KSS*2 weeks||Inter-Quartile Range|Median
47359|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Immediate Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|||Units on KSS*day||Inter-Quartile Range|Median
47435|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||bpm||Standard Deviation|Mean
47360|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Long-term Postoperative Period|"Anxiety measured by VAS (visual analog scale). Completed every 14th day. A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|Patients were only included in the analysis if they had completed VAS on anxiety in the long-term postoperative period. Single missing data were filled out using last observation carried forward.||mm*2 weeks||Inter-Quartile Range|Median
47361|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Immediate Postoperative Period|"Anxiety measured by VAS (visual analog scale). A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily - from inclusion till 8 days postoperatively|||mm*day||Inter-Quartile Range|Median
47362|NCT01355523|Primary|Intention to Treat (Overestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as “YES” for depression."|Intention to treat (overestimate) - depression at one point in the study period (not baseline)|"All missing data have been analyzed as YES depression."||participants|||Number
47363|NCT01355523|Primary|Intention to Treat (Underestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as “NO” depression."|Intention to treat (underestimate) - depression at one point in the study period (not baseline)|"All missing MDI data have been analyzed as NO depression."||participants|||Number
47364|NCT01355523|Primary|Per Protocol - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 This analysis includes only patients who have taken study medication as planned."|Per protocol - depression at one point in the study period (not baseline)|Includes only patients who have taken the study medication as planned||participants|||Number
47365|NCT01355523|Primary|Major Depression Inventory (MDI)- Depression at One Point in the Study|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Diagnostic scale using the ICD-10 algorithm:~Mild depression: 2 core symptoms and 2 other symptoms Moderate depression: 2 core symptoms and 4 other symptoms Severe depression: 3 core symptoms and 5 other symptoms~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50"|Depression at one point in the study (not including baseline) out of 4 measurements at app. day 21, day 35, day 63 and day 91 of the study.|Includes all patients who have completed at least one other MDI than baseline||participants|||Number
47366|NCT01355484|Primary|Lean Body Mass|Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.|Day 84|Subjects included in the Full Analysis Set||percentage of subjects||95% Confidence Interval|Number
47367|NCT01355484|Primary|Physical Function|Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.|Day 84|Subjects included in the Full Analysis Set||percentage of subjects||95% Confidence Interval|Number
47368|NCT01355471|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population(i.e. Hours 3,6,9,12)||participants|||Number
47369|NCT01355458|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12)||participants|||Number
47370|NCT01355419|Secondary|Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients|Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy|baseline and at 3 months|||steps||Standard Deviation|Mean
47371|NCT01355419|Primary|Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients|change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy|baseline and at 3 months|||minutes||Standard Deviation|Mean
47898|NCT01347840|Secondary|Hemoglobin A1c and Lipid Panel|These laboratory values will be collected at Screening, Visit 8, and Visit 10.|16 months|||units on a scale|||Number
47372|NCT01355081|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment|The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).||scores on a scale||Standard Error|Least Squares Mean
47373|NCT01355081|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate."|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).||scores on a scale||Standard Error|Least Squares Mean
47374|NCT01355081|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment|The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward.||scores on a scale||Standard Error|Least Squares Mean
47375|NCT01355081|Secondary|Percentage of Patients With MADRS Remission After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.|Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.||percentage of participants|||Number
47376|NCT01355081|Secondary|Percentage of Patients With MADRS Response After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.||percentage of participants|||Number
47377|NCT01355081|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug; who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last observation carried forward.||scores on a scale||Standard Error|Least Squares Mean
47378|NCT01355068|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
47379|NCT01355068|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||hr||Standard Deviation|Mean
47380|NCT01355068|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrap)|AUC%extrap is the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as (AUC [0-∞] minus AUClast)*100/ AUC [0-∞], where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Percent AUC||Standard Deviation|Geometric Mean
47381|NCT01355068|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
47382|NCT01355068|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
47383|NCT01355068|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
47384|NCT01354990|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months|||participants|||Number
47385|NCT01354990|Primary|Number of Participants With Concomitant Therapies||Up to approximately 28 months|||participants|||Number
47386|NCT01354990|Primary|Age of Participants Prescribed Sitagliptin||Up to approximately 28 months|||years||Standard Deviation|Mean
47387|NCT01354990|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months|||participants|||Number
47388|NCT01354938|Primary|Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. The change from Baseline of 4 or more units lower, consistent with a clinically significant change in the participant, was considered in this study to be the ‘minimal clinically important difference’ (MCID).|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data||participants|||Number
47389|NCT01354938|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|AE=any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. SAE=an event meeting any of the following criteria: results in death, hospitalization, prolongation of hospitalization, is life-threatening, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention, spontaneous or elective abortion. AEs and SAEs were collected during the course of the study. See the Reported Adverse Event section for details.|From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)|All enrolled participants||participants|||Number
47390|NCT01354938|Primary|St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the participant.|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data||units on a scale||Standard Deviation|Mean
47391|NCT01354899|Secondary|Overall Experience of Use of the Dressing|Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent|During 5 days|||participants|||Number
47392|NCT01354899|Primary|Erythema (No/Yes)|Measure number of skin breakdown during from enrolment to termination.|During 5 days|||participants|||Number
47393|NCT01354652|Secondary|Overall OLT-free Survival|Overall OLT-free survival until development of OLT and death and participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months|Participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months||||||
47394|NCT01354652|Secondary|Arterial pH and Anion Gap in Cases With Elevated Blood Lactate Levels (at the Time of Detection and Peak Levels|Arterial pH and anion gap in cases with elevated blood lactate levels (at the time of detection and peak levels until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
47395|NCT01354652|Secondary|Frequency of Concomitant Prescribed Medications Possibly Associated With Lactic Acidosis Other Than NTRIs|Frequency of concomitant prescribed medications possibly associated with lactic acidosis other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
47396|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Caused by Etiologies Other Than NTRIs|incidence of elevated venous lactate levels more than 2 mmol/L caused by etiologies other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks||||||
47436|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.||beats per minute (bpm)||Standard Deviation|Mean
47398|NCT01354652|Primary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L of Any Etiology|incidence of elevated venous lactate levels more than 2 mmol/L of any etiology until development of lactic acidosis, orthotropic liver transplantation (OLT), death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Our study was terminated early with only 5 participant enrolled. We gained lactic acid levels for the 5 patients (all elevated), however we considered that it was not sufficient to be analyzed. Morever, we did not further investigate the etiology for elevated lactic acid levels in the 5 patients and secondary outcomes were not recorded here.||participants|||Number
47399|NCT01354431|Secondary|Median Progression Free Survival (PFS) in Months at Interim Data Cut-off - Randomized Population|PFS: the time from randomization to the date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) was measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Participants were censored if they had not experienced disease progression (they were still on treatment or in follow-up) or had received subsequent cancer therapy. Disease Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to March 2015 data cut off. Study on-going.||Months||80% Confidence Interval|Median
47400|NCT01354431|Secondary|Median Overall Survival in Months at Interim Data Cut-off - Randomized Population|Median Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to interim data cut off, March 2015. Study on-going.||Months||80% Confidence Interval|Median
47401|NCT01354431|Secondary|Number of Participants With Best Overall Response at Primary Endpoint - Randomized Population|Best response defined as the best response across all time points. Primary endpoint=116 events, approximately 2 years. Tumor response was evaluated by investigator according to RECIST version 1.1. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; partial response (PR): at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease Progression (PD) was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions; Stable disease: neither shrinkage to qualify for PR or increase to qualify for PD.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All Randomized participants were summarized up to Primary endpoint data cut off, approximately 2 years.||participants|||Number
47402|NCT01354431|Secondary|Objective Response Rate (ORR) at Primary Endpoint- Randomized Population|Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate (ORR) was defined as the number of responders divided by the number of randomized participants; Responders=complete response (CR) or partial response (PR). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR was estimated along with exact 80% Confidence Interval (CI) using the Clopper and Pearson method.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All randomized participants were analyzed up to Primary endpoint, approximately 2 years.||percentage of participants||80% Confidence Interval|Number
47403|NCT01354431|Primary|Median Progression Free Survival (PFS) at Primary Endpoint - Randomized Population|PFS: time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) and measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator’s assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All participants who were randomized to a treatment arm.||Months||80% Confidence Interval|Median
47404|NCT01354223|Secondary|Evaluation of Average Lens Wearing Time - Average Daily Hours Worn|The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|||hours||Standard Deviation|Mean
47405|NCT01354223|Primary|Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better|"The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B.~Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared."|week 1 visit, week 2 visit, month 1 visit, month 2 visit combined|For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.||percentage of possible examinations|Participants||Number
47437|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||millimeter of mercury (mmHg)||Standard Deviation|Mean
47406|NCT01354223|Secondary|Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort|"The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens.~Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3)."|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.||percentage of eyes|Participants||Number
47407|NCT01354223|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses.~The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit)."|Any occurrence from dispensing to month 3 visit|Unique eyes are defined as each individual eye in the study.||number of adverse events|Participants||Number
47408|NCT01354223|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses.~The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings||units on a scale|Participants|Full Range|Mean
47409|NCT01354145|Secondary|Use of Acetaminophen|"Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit.~Daily consumption of acetaminophen was calculated as an average."|3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728)|Intention-To-Treat||Daily number of caplets taken||Standard Deviation|Mean
47410|NCT01354145|Secondary|Percentage of Participants With Presence of Joint Swelling and Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and effusion.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||percentage of participants|||Number
47411|NCT01354145|Secondary|Short Form (SF-36) Health Survey|"The SF-36 is composed of 35 items measuring:~8 health concepts (or dimensions), [(Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH)]~and 1 reported health transition item.~The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||Scores on a scales||Standard Deviation|Median
47412|NCT01354145|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
47413|NCT01354145|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
47414|NCT01354145|Secondary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
47415|NCT01354145|Secondary|Visual Analog Scale (VAS)|Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson’s VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: “Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line”. Left hand marker represents “No pain” and right hand marker represents “The worst pain imaginable”.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||centimeters||Standard Deviation|Mean
47438|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.||millimeter of mercury (mmHg)||Standard Deviation|Mean
47416|NCT01354145|Secondary|Percentage of Participants With the Presence of Extrusion in the Meniscus|The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||percentage of participants|||Number
47417|NCT01354145|Secondary|Synovial Fluid Volume|To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||mililiters||Standard Deviation|Mean
47418|NCT01354145|Secondary|Bone Marrow Lesions Score|"To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.~The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows:~Grade 0 = Absence of lesion in the sub region~Grade 1 = less than 25% of the surface~Grade 2 = 25-50% of the surface~Grade 3 = more than 50% of the surface"|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||units on a scale||Standard Deviation|Mean
47419|NCT01354145|Secondary|Synovial Membrane Thickness|"To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.~The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||milimeters||Standard Deviation|Mean
47420|NCT01354145|Secondary|Cartilage Volume in the Medial Compartment|To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||cubic milimeters||Standard Deviation|Mean
47421|NCT01354145|Secondary|Cartilage Volume Loss of the Global Knee|To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-to-Treat||cubic milimeters||Standard Deviation|Mean
47422|NCT01354145|Primary|Cartilage Volume Loss of the Lateral Compartment|To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat||cubic milimeters||Standard Deviation|Mean
47423|NCT01354106|Primary|Skin Trauma|"Expert grader using Erythema/Edema Scale 0=No visible response~mild response~moderate response~severe response~extreme response"|24 hours|||Units on a scale||Standard Deviation|Mean
47424|NCT01354028|Primary|Number of Infants Sleeping at the End of the Massage Period|Investigators compared the number of infants sleeping at the end of the massage period with the percentage of infants sleeping at the same time on the non massage day.|Minute massage ended|A convenient number of infants was determined for this pilot study||participants|||Number
47425|NCT01354028|Secondary|Heart Rate|Heart rate during massage therapy|During massage therapy|A convenient size was determined for this pilot study||beats per minute||Standard Deviation|Mean
47426|NCT01354028|Secondary|Oxygen Saturation Levels During Massage|Infants in the NICU are routinely attached to pulse oximeter monitors that measure oxygen saturation continuously. If the infant is stressed, oxygen levels may drop. Oxygen saturation was monitored during massage therapy as a routine measure but also to ensure that infants did not become stressed during the massage.|During massage|We determined a convenient size for this pilot study||percentage of oxygen saturation||Standard Deviation|Mean
47427|NCT01354028|Primary|Quality of Sleep, Defined by Number and Duration of Awakenings, and Longest Sustained Sleep Period for the Study Interval. These Data Were Measured by the Actigraph Software and Summarized as Percentage of Time Spent Sleeping, or Sleep Efficiency|Sleep onset following the first quiet alert state after the 9 AM feed Sleep end time Number of awakenings and duration of the awakenings during the study period Longest sustained sleep period for the study interval Percentage of time spent sleeping, or sleep efficiency, will be used to summarize the data, comparing sleep efficiency over 2 days and using each infant as his/her own control|Participants were followed for two days|A convenient number of participants was selected for this pilot study.||percentage of time spent sleeping||Standard Deviation|Mean
47428|NCT01354015|Secondary|Fall in HbA1c Over 3 Months|Fall in HbA1c|3 months|||percentage of total Hb||Standard Deviation|Mean
47429|NCT01354015|Primary|Change in HbA1c|change in A1c from baseline in intervention and control groups|6 months|||percentage of Hb||Standard Deviation|Mean
47430|NCT01353976|Secondary|Mycological Cure|Mycological Cure defined as negative KOH and negative culture at Day 43.|Day 43|MITT||Participants|||Number
47431|NCT01353976|Secondary|Effective Treatment|Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43.|Day 43|MITT||Participants|||Number
47432|NCT01353976|Primary|Complete Cure|Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.|Day 43|MITT||Participants|||Number
47433|NCT01353963|Primary|Change From Baseline in Weight at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||kg||Standard Deviation|Mean
47434|NCT01353963|Primary|Change From Baseline in Weight at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.||kilogram (kg)||Standard Deviation|Mean
47439|NCT01353963|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.|Week 4 to Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.||Participants|||Number
47440|NCT01353911|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 72|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 72|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
47441|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (TND) HCV RNA at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after the end of all treatment (up to 72 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
47442|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (TND) HCV RNA at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after the end of all treatment (up to 60 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
47443|NCT01353911|Secondary|Percentage of Participants Achieving Rapid Viral Response (RVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). RVR was defined as undetectable (TND) HCV RNA at Week 4 of study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|After 4 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
47444|NCT01353911|Secondary|Median Time to First Achievement of Undetectable HCV RNA During Treatment|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 48 weeks of treatment)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens. Participants in the FAS not achieving TND were censored.||days||95% Confidence Interval|Median
47445|NCT01353911|Primary|Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|APaT population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||participants|||Number
47482|NCT01353508|Secondary|Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker|BNP was analyzed at a central laboratory.|0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
47446|NCT01353911|Primary|Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|All Participants as Treated (APaT) population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||participants|||Number
47447|NCT01353911|Primary|Percentage of Participants Achieving Complete Early Viral Response (cEVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). cEVR was defined as undetectable HCV RNA (target not detected [TND]) at Week 12. 95% confidence intervals provided based on the Clopper-Pearson method.|After 12 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.||percentage of participants||95% Confidence Interval|Number
47448|NCT01353898|Primary|Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo|Blood was collected at baseline and on Day 10, and the plasma concentration for HIV-1 RNA was determined using the Abbott RealTime HIV assay.|Baseline and Day 10 (24 hours post-dose)|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.||log10 copies/mL||Standard Error|Mean
47449|NCT01353898|Secondary|The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection|Plasma concentration of MK-1972 was determined from blood collected from HIV-1 infected participants on Day 10 : pre-dose up to 24 hours post-dose in order to determine the AUC0-24hrs.|Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. MK-1972 was not measured for the placebo group since it did not receive any of this drug.||nM.hr||Geometric Coefficient of Variation|Geometric Mean
47450|NCT01353898|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an adverse event.|From consent to 14 days after the last dose (up to Day 24)|All participants who received at least one dose of the investigational drug, according to the treatment they actually received.||Participants|||Number
47451|NCT01353859|Secondary|C-Reactive Protein Levels|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Baseline, Weeks 4, 8, 12,16, 20, and 24|ITT Population||mg/L||Standard Deviation|Mean
47452|NCT01353859|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation rate was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population||mm/hr||Standard Deviation|Mean
47453|NCT01353859|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response|ACR20/50/70 response was defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) as well as improvement in at least 3 of the 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the health assessment questionnaire [HAQ]); and acute phase response: C-reactive protein (CRP) or ESR.|Week 24|ITT Population||percentage of participants|||Number
47454|NCT01353859|Secondary|Percentage of Participants With DAS28 <3.2 by Visit|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
47455|NCT01353859|Secondary|Time to Achieve DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 remission was defined as DAS28 <2.6. Time to achieve remission was calculated in weeks as the time from the date of first infusion to the date of first achieving remission.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population||weeks||Standard Deviation|Mean
47456|NCT01353859|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Remission was defined as DAS28 <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
47899|NCT01347840|Secondary|Area Under the Curve of Glucose|This variable will measure the combined effects of glucose concentration and duration.|16 months|||units on a scale|||Number
47457|NCT01353859|Secondary|Time to Clinically Significant Improvement in DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement is a reduction in DAS28 score of at least 1.2 units. Time to clinically significant improvement was determined in weeks from the date of first infusion to the date of first achievement of reduction of 1.2 units in DAS28.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population||weeks||Standard Deviation|Mean
47458|NCT01353859|Secondary|Percentage of Participants With a Clinically Significant Improvement in DAS28 Score|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement in DAS28 score was defined as a reduction of at least 1.2 units.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population||percentage of participants|||Number
47459|NCT01353859|Secondary|Time to Achieve Low Disease Activity (DAS28 ≤3.2)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity; time to low disease activity was calculated as the time in weeks from the date of first infusion to the first achievement of DAS28 ≤3.2|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||weeks||Standard Deviation|Mean
47460|NCT01353859|Primary|Percentage of Participants Achieving Low Disease Activity Score|Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population: All participants randomized in the study who received administration of at least one dose of the study drug and who had the last week 24 assessment performed.||percentage of participants|||Number
47461|NCT01353664|Primary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days|Safety Population = Participants who received at least one dose of study drug.||Participants|||Number
47462|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation|All SNA subjects were to be evaluated by expert neurologists for existing neurological deficits prior to ablation procedure. After procedure, those subjects were also to be assessed for new neurological deficits.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.||percentage of participants|||Number
47463|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation|Evaluation of post-ablation generation incidence of asymptomatic cerebral microembolic lesions post ablation, as documented by MRI. All microembolic lesions reported in this study are asymptomatic.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.||percentage of subjects with ACE Lesion|||Number
47464|NCT01353586|Secondary|Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure|This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure.|6 and12 months post study procedure|This analysis population is the effectiveness cohort, excluding 2 subjects who withdrew consent prior to Day 91. The effectiveness cohort includes those who received treatment with the investigational device; but does not include 20 workflow and 22 roll-in subjects.||percentage of participants||95% Confidence Interval|Number
47465|NCT01353586|Secondary|Incidence of Completion of Ablation Procedure|This secondary outcome describes the acute effectiveness, which is defined as pulmonary vein isolation (PVI) documented by confirmed entrance block (with or without the use of a focal catheter).|From 7 days to 12 months post study procedure|Safety population excluding one subject without source document at site||percentage of participants||95% Confidence Interval|Number
47466|NCT01353586|Secondary|Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation|Incidence of narrowing of PV and stenosis at 3 months post ablation, for subjects with available CT/MRA scans at 3 months. PV Stenosis is defined as 70% or more PV diameter reduction.|Three months after index ablation|Subjects in safety analysis group who also had CT/MRI PV scan available at the 3-month post-ablation interval (144 of 160 subjects)||percentage of participants with CT/MRI|||Number
47467|NCT01353586|Secondary|Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months|This secondary safety endpoint includes non-primary serious adverse events within 7 days post-procedure and serious adverse events from 7 days to 12 months post-procedure.|12 months post study procedure|Safety population||percentage of participants|||Number
47523|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47468|NCT01353586|Primary|Incidence of Freedom From Documented Symptomatic Atrial Fibrillation|The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.|Evaluated from Day 91 to Day 240|Effectiveness cohort: This population excludes those subjects who never underwent insertion of study catheter, those who terminated procedure prior to ablation, and those who were enrolled during the Workflow phase (20 subjects) and Roll-in phase (22 subjects). This analysis also excludes two subjects who withdrew consent post ablation.||percentage of participants||95% Confidence Interval|Number
47469|NCT01353586|Primary|The Incidence of Early Onset Primary Adverse Events|The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Primary adverse events include pericardial effusion requiring intervention, atrial perforation, pericarditis requiring intervention, cardiac tamponade, pneumothorax, death, pulmonary edema, diaphragmatic paralysis, heart block, stroke / cerebrovascular accident (CVA), hospitalization (initial and prolonged), thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), and vascular access complications. In addition, pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure are deemed primary adverse event.|Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure)|Safety Population as defined above||percentage of participants||95% Confidence Interval|Number
47470|NCT01353508|Secondary|Supine Pulse Rate|Pulse rate measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||BPM||Standard Deviation|Mean
47471|NCT01353508|Secondary|Supine Diastolic Blood Pressure|Diastolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmHg||Standard Deviation|Mean
47472|NCT01353508|Secondary|Supine Systolic Blood Pressure|Systolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmHg||Standard Deviation|Mean
47473|NCT01353508|Secondary|Renal Blood Flow (RBF) Over Time|RBF was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL/min||Standard Deviation|Mean
47474|NCT01353508|Secondary|Glomerular Filtration Rate (GFR) Over Time|GFR was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL/min||Standard Deviation|Mean
47475|NCT01353508|Secondary|Percent Change From Baseline in Blood Plasma Creatinine|Blood plasma creatinine was analyzed at a central laboratory.|4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
47476|NCT01353508|Secondary|Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
47477|NCT01353508|Secondary|Percent Change From Baseline in Aldosterone Biomarker|Aldosterone was analyzed at a central laboratory.|6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
47478|NCT01353508|Secondary|Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker|NT-proBNP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
47479|NCT01353508|Secondary|Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker|CT-proET-1 was analyzed at a central laboratory.|12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
47480|NCT01353508|Secondary|Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker|ProCNP was analyzed at a central laboratory.|2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.||Percentage change||95% Confidence Interval|Least Squares Mean
47481|NCT01353508|Secondary|Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker|MR-proADM was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.||Percentage change||95% Confidence Interval|Least Squares Mean
47483|NCT01353508|Secondary|Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker|MR-proANP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||Percentage change||95% Confidence Interval|Least Squares Mean
47484|NCT01353508|Secondary|Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours|cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM.|day 1, day 6, day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||nmol/24 hours||95% Confidence Interval|Least Squares Mean
47485|NCT01353508|Secondary|7-day Cumulative Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|7-day cumulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL||95% Confidence Interval|Least Squares Mean
47486|NCT01353508|Secondary|24-hour Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mL/24 hours||95% Confidence Interval|Least Squares Mean
47487|NCT01353508|Primary|Cumulative 7-day Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|7 day-cummulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmol/7 days||95% Confidence Interval|Least Squares Mean
47488|NCT01353508|Primary|24-hour Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.||mmol/24 hours||95% Confidence Interval|Least Squares Mean
47489|NCT01353274|Secondary|Proportion of Patients Who Normalised Their BP|Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||Percentage of patients (normalised BP)|||Number
47490|NCT01353274|Secondary|Proportion of Patients Who Achieved the Target BP|Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||Percentage of patients (target BP)|||Number
47491|NCT01353274|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||mmHg||Standard Deviation|Mean
47492|NCT01353274|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg Fixed Dose Combination (FDC) and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||mmHg||Standard Deviation|Mean
47493|NCT01353274|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 months|Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact||participants|||Number
47494|NCT01353144|Secondary|Number of Participants Deveoping Peptic Ulcer Bleeding|Number of participants deveoping peptic ulcer bleeding during 8-week study period|8 weeks|||participants|||Number
47495|NCT01353144|Primary|Number of Participants in Whom Peptic Ulcer Was Healed|Number of participants in whom peptic ulcer was healed at week 8|8 weeks|||participants|||Number
47496|NCT01353079|Secondary|Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)|"Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS).~Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season."|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.||Scores on a scale||Standard Deviation|Least Squares Mean
47506|NCT01352845|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1||Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
47900|NCT01347840|Secondary|Subject Questionnaires|The subscales and total scores as set out in the scoring algorithms for Food Craving Inventory-II and Questionnaire on Craving for Sweet and Rich Foods will be presented.|16 months|||participants|||Number
47497|NCT01353079|Secondary|Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)|Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.|2011 ragweed pollen season; 8/2011 - 10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement||Scores on a scale||Standard Deviation|Least Squares Mean
47498|NCT01353079|Secondary|Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)|Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.||Scores on a scale||Standard Deviation|Least Squares Mean
47499|NCT01353079|Primary|Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]|Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|2011 ragweed pollen season, 8/2011 -10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement||Scores on a scale||Standard Deviation|Least Squares Mean
47500|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
47501|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.|||||
47502|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Titer||95% Confidence Interval|Geometric Mean
47503|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary endpoint ‘Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1’.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
47504|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
47505|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1||One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
47522|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.||Percentage of participants||95% Confidence Interval|Number
47507|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain. This outcome measure was planned to be analyzed for Group 1 only.||Titers||95% Confidence Interval|Geometric Mean
47508|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
47509|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.||Percentage of participants||95% Confidence Interval|Number
47510|NCT01352845|Primary|Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. Here, number of participants analyzed signifies subjects that were evaluable for this outcome measure.||Days||Standard Deviation|Mean
47511|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
47512|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
47513|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
47514|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47515|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.||Percentage of participants||95% Confidence Interval|Number
47516|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47517|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47518|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
47519|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
47520|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
47521|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47525|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
47526|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
47527|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
47528|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47529|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47530|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.||Percentage of participants||95% Confidence Interval|Number
47531|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47532|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
47533|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
47534|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
47535|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47536|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.||Percentage of participants||95% Confidence Interval|Number
47537|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
47538|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
47539|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
47540|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, 'N' signifies participants with known values reporting specific characteristic.||Percentage of participants||95% Confidence Interval|Number
47541|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.||Percentage of participants||95% Confidence Interval|Number
47542|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.||Percentage of participants||95% Confidence Interval|Number
47543|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.||Percentage of participants||95% Confidence Interval|Number
47544|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.||Percentage of participants||95% Confidence Interval|Number
47545|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.||Percentage of participants||95% Confidence Interval|Number
47546|NCT01352845|Primary|Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1|Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
47547|NCT01352793|Secondary|Number of Days Participant Missed School or Work Due to Adverse Events (AEs)||Vaccination 1 up to 1 month after Vaccination 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||days||Full Range|Median
47548|NCT01352793|Secondary|Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 minutes after Vaccination 1, 2, 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
47549|NCT01352793|Secondary|Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
47550|NCT01352793|Secondary|Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
47551|NCT01352793|Secondary|Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
47706|NCT01350414|Secondary|Emergency Room Visits for Respiratory Symptoms|Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage subjects ER respir. symptoms||95% Confidence Interval|Number
47552|NCT01352793|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
47553|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 3|Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).||percentage of participants||95% Confidence Interval|Number
47554|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 2|Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.||percentage of participants||95% Confidence Interval|Number
47555|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 1|Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.||percentage of participants||95% Confidence Interval|Number
47556|NCT01352793|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study|An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Vaccination 1 up to 6 months after Vaccination 3|Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.||percentage of participants||95% Confidence Interval|Number
47557|NCT01352741|Secondary|Double-blind Comparative Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~“How would you rate your overall satisfaction with your current pain treatment?”: Excellent, Very Good, Good, Fair and Poor."|End of Comparative Period at Final Evaluation Visit (Day 77)|Last Observation Carried Forward (LOCF); Per Protocol Set||participants|||Number
47558|NCT01352741|Secondary|Open-label Titration Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~“How would you rate your overall satisfaction with your current pain treatment?”: Excellent, Very Good, Good, Fair and Poor."|End of Open-label Titration Period at Randomization Visit (Day 22)|Last Observation Carried Forward (LOCF); Per Protocol Set||participants|||Number
47559|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Randomization Visit (Day 22) to Final Evaluation (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
47560|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
47561|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Baseline Visit (Day 1)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
47562|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12)|Double-Blind Comparative Population. Per Protocol Set (PPS).||participants|||Number
47563|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||participants|||Number
47901|NCT01347840|Secondary|Adiponectin and Lectin|These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.|16 months|||units on a scale|||Number
47564|NCT01352741|Secondary|Double-blind Comparative Period: Sleep Evaluation Questionnaire - Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline Visit (Day -12); Randomization Visit (Day 1); Final Evaluation Visit (Day 77)|Per Protocol Set.||hours||Standard Deviation|Mean
47565|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Hours Slept in the Double-blind Comparative Period Population|"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).||hours||Standard Deviation|Mean
47566|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Time Slept|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~The participant was asked: How long did you sleep last night? [Answered in hours and minutes]."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||hours||Standard Deviation|Mean
47567|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Number of Awakenings|The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings. Participants were asked: How many times did you wake up during the night? The change in the Number of Awakenings was calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Final Evaluation Visit (Day 77). A negative change indicates that the number of awakenings in a treatment group have gone down since the Baseline or Randomization Visit. In general pain can interfere with sleep, one potential indicator is the number of awakenings.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).||Number of Awakenings||Standard Deviation|Mean
47568|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation - Number of Awakenings in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||Number of Awakenings||Standard Deviation|Mean
47569|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Number of Awakenings|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||Number of Awakenings||Standard Deviation|Mean
47570|NCT01352741|Secondary|Double-blind Comparative Period Sleep Evaluation Questionnaire: Change in Latency|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).||hours||Standard Deviation|Mean
47571|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Latency in the Double-blind Comparative Period Population|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. Sleep evaluation questionnaire (SQ) items|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).||hours||Standard Deviation|Mean
47572|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Latency|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the sleep latency.~To assess latency the participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||hours||Standard Deviation|Mean
47573|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47784|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity||mIU/mL||95% Confidence Interval|Mean
47574|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind Comparative Population; Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47575|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47576|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47577|NCT01352741|Secondary|Double-blind Comparative Period: Clinician Global Impression of Change (CGIC)|"In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Full Analysis Set (FAS).||participants|||Number
47578|NCT01352741|Secondary|Double-blind Comparative Period: Patient Global Impression of Change (PGIC)|"In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale where the patient's rates overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-blind comparative population. Full Analysis Set (FAS).||participants|||Number
47579|NCT01352741|Secondary|Double-blind Comparative Period: Change EuroQol-5 Dimension (EQ-5D) Health Status Index|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47580|NCT01352741|Secondary|Open-label Titration Period: EuroQol-5 Dimension (EQ-5D) Health Status Index Score for the Double-blind Comparative Period Population|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47581|NCT01352741|Secondary|Double-blind Comparative Period: Change in Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47582|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47583|NCT01352741|Secondary|Double-blind Comparative Period: Changes in the Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical summary scores were calculated from the individual responses to those questions covering physical health. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47584|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47585|NCT01352741|Secondary|Double-blind Comparative Period: Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. Spontaneous Pressing Pain Subscore). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 10 (100 for the overall score) . A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47586|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment in the Double-blind Comparative Period Population|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47587|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
47588|NCT01352741|Secondary|Double-blind Comparative Period: Change in painDETECT Final Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 19. A negative change indicated a decrease in their neuropathic component of pain."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47589|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population painDETECT Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47785|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity||mIU/mL||95% Confidence Interval|Mean
47590|NCT01352741|Secondary|Open-label Titration Period: painDETECT Assessments|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
47591|NCT01352741|Secondary|Double-blind Comparative Period: Change in Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit.~A negative change indicates that the pain intensity decreased from the start of the trial."|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47592|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric Rating Scale (NRS), where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked : Please rate your pain intensity by assessing the one number that best describes your worst pain during the past 24 hours prior to the visit."|Enrollment Visit (Day-12); Baseline Visit (day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS)||units on a scale||Standard Deviation|Mean
47593|NCT01352741|Secondary|Open-label Titration Period: Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit."|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
47594|NCT01352741|Secondary|Double-blind Comparative Period: Change in NRS-3 Pain Intensity Score for the Radiating Pain|"NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot).~The value reported represents the change from the randomization visit (i.e., the last 3 days in the titration period) to the end of the double-blind comparative period (i.e., the last 3 days in the comparative period). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit)."|Randomization Visit (Day 22); End of Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47595|NCT01352741|Secondary|Open-label Titration Period: Radiating Mean Pain Intensity Score for the Comparative Period Population|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47596|NCT01352741|Secondary|Open-label Titration Period: Radiating Pain|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.||units on a scale||Standard Deviation|Mean
47597|NCT01352741|Secondary|End of Open-label Pick-up Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Final Evaluation Visit (Day 77)|Observed.||units on a scale||Standard Deviation|Mean
47598|NCT01352741|Secondary|Open-label Continuation Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Observed values.||units on a scale||Standard Deviation|Mean
47599|NCT01352741|Secondary|Open-label Titration Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine. This is the treatment period prior to the primary outcome period.|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed values.||units on a scale||Standard Deviation|Mean
47600|NCT01352741|Primary|Change in the Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|"The primary endpoint is defined as the comparison of tapentadol prolonged release (PR) 300 mg plus 200 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) from the randomization visit to the final evaluation visit.~Theoretically a maximum decrease of -10 and an increase of +4 in the pain intensity would have been possible. A negative sign indicates a decrease in pain intensity from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline visit)."|Randomization (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).||units on a scale||Standard Deviation|Mean
47601|NCT01352715|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline|Fasting was for 8 hours and the metabolic panel was drawn locally.|Study entry and week 48|Intention to treat: All 512 participants without a major eligibility violation with data available at entry and week 48 were included in their assigned randomized treatment arm. total cholesterol (Arm A N=216 B N=220) HDL (Arm A N=219 B N=223) LDL (Arm A N=202 B N=205) triglycerides (Arm A N=219 B N=222), glucose (Arm A N=213 B N=223)||mg/dL||95% Confidence Interval|Mean
47602|NCT01352715|Secondary|Percentage of Time Spent in Hospital|The percentage of total study time that participants were in hospital.|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without a major eligibility violation were in the analysis: participants were analyzed per original assigned randomized treatment.||percentage of time spent in hospital|||Number
47603|NCT01352715|Secondary|Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death|Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.||participants|||Number
47604|NCT01352715|Secondary|Number of Participants With a New AIDS-defining Events or Death|AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO)|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.||participants|||Number
47605|NCT01352715|Secondary|Number of Participants Discontinuing Randomized Treatment for Toxicity|Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations.|From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)|Competing risk approach: Time was measured from start of randomized treatment until the date of randomized treatment discontinuation for toxicity. Randomized treatment discontinuation for other reasons was considered as an independent competing risk, and participants discontinuing the study were censored on the date of last participant contact.||participants|||Number
47606|NCT01352715|Secondary|Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline|The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs.|From start of randomized treatment to off randomized treatment (up to 96 weeks)|As treated: Participants on randomized treatment are included in this analysis.||participants|||Number
47607|NCT01352715|Secondary|Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure|Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline.|From study entry through to week 96|Participants with virologic failure, and with a pair of baseline and virologic failure sequences available, were included in the analysis.||participants|||Number
47608|NCT01352715|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry.|Study entry and week 48|Intention to treat: All 488 participants without a major eligibility violation, and with baseline and week 48 data available were used in the analysis: participants were analyzed per original assigned randomized treatment.||cells/mm^3||95% Confidence Interval|Mean
47609|NCT01352715|Primary|Cumulative Probability of Virologic Failure by Week 48|The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used.|From study entry to week 48|Intention to treat: All 512 participants without a major eligibility violation were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
47610|NCT01352585|Secondary|Hematocrit Level||1 year|Safety Set||Hematocrit (fraction of 1)||Standard Deviation|Mean
47611|NCT01352585|Secondary|Hemoglobin Concentration||1 year|Safety set||g/L||Standard Deviation|Mean
47612|NCT01352585|Secondary|Differential WBC Count||1 year|Safety Set||percent||Standard Deviation|Mean
47613|NCT01352585|Secondary|White Blood Cell (WBC) Count||1 year|Safety Set||WBC Count (x10^9/L)||Standard Deviation|Mean
47614|NCT01352585|Secondary|Red Blood Cell (RBC) Count||1 year|The Safety Set consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride.||RBC Count (x10^12/L)||Standard Deviation|Mean
47615|NCT01352585|Secondary|Platelet Count||1 year|FAS||Platelets (x10^9/L)||Standard Deviation|Mean
47616|NCT01352585|Secondary|Number of Patients With Platelet Count ≤400x10^9/L After 12 Months|A platelet count of ≤400x10^9/L after 12 months is considered a complete response.|1 year|FAS||participants|||Number
47617|NCT01352585|Primary|Number of Patients With Platelet Count ≤600x10^9/L After 12 Months|A platelet count of ≤600x10^9/L after 12 months is considered at least a partial response.|1 year|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who had at least 1 post-baseline platelet count and their JAK2 mutation status was assessed. 35 patients in the FAS had a viable platelet sample.||participants|||Number
47618|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Erectile Function Domain|Self-reported erectile function over the past 4 weeks. IIEF erectile function was the sum of Q1 through Q5 and Q15 of the IIEF. Q1 through Q5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Q15 was scored 1 (no/low confidence) to 5 (high confidence). IIEF erectile function domain scores ranged from 1 to 30. Change was defined as endpoint minus baseline domain score. Change in IIEF erectile function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF EF domain score. Higher scores were indicative of better erectile function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
47619|NCT01352507|Secondary|Change in PAIRS Time Concerns Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The time concerns domain score was the average score for Items 1, 2, 6, 7, 8, 20, 24, and 25. Time concern domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS time concerns at Week 8 and Week 18 were averaged to produce an overall change in PAIRS time concerns domain score. Higher scores were indicative of more time concerns.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.||units on a scale||Standard Deviation|Mean
47620|NCT01352507|Secondary|Change in PAIRS Spontaneity Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The spontaneity domain score was the average score for Items 3, 12, 13, 16, 17, 19, 21, 22, and 28. Spontaneity domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS spontaneity domain at Week 8 and Week 18 were averaged to produce an overall change in PAIRS spontaneity domain score. Higher scores were indicative of greater spontaneity.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.||units on a scale||Standard Deviation|Mean
47621|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 3|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score was determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Change in the percentage of yes responses to SEP Q3 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q3."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 SEP post-baseline measurement.||"percentage of yes responses"||Standard Deviation|Mean
47622|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function over the past 4 weeks. IIEF orgasmic function was the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF orgasmic function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF orgasmic function domain score. Higher scores were indicative of better orgasmic function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
47623|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire over the past 4 weeks. IIEF sexual desire was the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF sexual desire domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF sexual desire domain score. Higher scores were indicative of increased sexual desire.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
47624|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction over the past 4 weeks. IIEF intercourse satisfaction was the sum of Q6, Q7, and Q8 of the IIEF. Scores ranged from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15. Change was defined as endpoint minus baseline domain score. Change in IIEF intercourse satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF intercourse satisfaction domain score. Higher scores were indicative of an increase in intercourse satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
47625|NCT01352507|Secondary|Drug Attributes Questionnaire (DRAQ) at Week 18|DRAQ was a questionnaire used to record explanations for why participants preferred a drug. Participants identified their first and second reasons for drug preference from a choice of 7 reasons. Each reason for drug preference includes participants who selected that reason as their first or second reason.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the DRAQ, and were analyzed according to their assigned treatment.||percentage of participants|||Number
47626|NCT01352507|Secondary|Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The sexual self-confidence domain score was the average score for Items 5, 10, 15, 23, 27, and 29. Sexual self-confidence domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS sexual self-confidence domain scores at Week 8 and Week 18 were averaged to produce an overall change in PAIRS sexual self-confidence domain score. Higher scores were indicative of greater sexual self-confidence.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.||units on a scale||Standard Deviation|Mean
47627|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 2|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of “yes” responses at endpoint minus the percentage of “yes” responses at baseline. Change in percentage of “yes” responses to SEP Q2 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q2."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 post-baseline SEP measurement.||"percentage of yes responses"||Standard Deviation|Mean
47628|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction over the past 4 weeks. IIEF overall satisfaction was the sum of Q13 and Q14. Scores ranged from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF overall satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF overall satisfaction domain score. Higher IIEF overall satisfaction domain scores were indicative of greater overall satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.||units on a scale||Standard Deviation|Mean
47629|NCT01352507|Secondary|Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ|PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, “For the treatment preference you selected in Q1, what is your degree of preference?”. Choices were moderate or strong.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.||percentage of participants|||Number
47630|NCT01352507|Primary|"Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the Phosphodiesterase 5 Inhibitor Treatment Preference Questionnaire (PITPQ)"|PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.||percentage of participants||95% Confidence Interval|Number
47631|NCT01352442|Secondary|Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months|||Scores on a scale||95% Confidence Interval|Mean
47632|NCT01352442|Primary|Uncorrected Near Visual Acuity 20/32 or Better||12 months|||percentage of subjects|||Number
47633|NCT01352416|Primary|Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.|Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.|The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged|Study was prematurely terminated. Data for this Outcome Measure were not collected|||||
47634|NCT01351506|Secondary|Acute Kidney Injury|New acute kidney injury in ICU|Acute kidney injury|||participants|||Number
47635|NCT01351506|Secondary|Re Intubation Within 72 Hours|Patient who need re-intubation within 72 hours|ICU complications up to 28 days after ICU admission|All||participants|||Number
47636|NCT01351506|Primary|In Hospital Mortality|28 days mortality if patient still have be admitted in hospital.|within 28 days after ICU admission to dead|Total 465 patients||participants|||Number
47637|NCT01351337|Other Pre-specified|The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results|The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative). The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive). The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.|During the operation|||percentage of stimulation sites|||Number
47638|NCT01351337|Secondary|Postoperative Motor Function and Long-time Functional Status|Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge. The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale. Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed. Grade 2: Muscle can onlly move if resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.|3 days to 6 months after surgery|||participants|||Number
47639|NCT01351337|Primary|Extent of Tumor Resection|Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas. The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume. Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.|within 3 days|||participants|||Number
47640|NCT01351090|Secondary|Pain Intensity Difference (PID) Scores|Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.|6 hours after study drug administration|||units on a scale||Standard Deviation|Mean
47641|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours||8-hour intervals from 24 hours after the start of dosing through 48 hours|||mg||Standard Deviation|Mean
47646|NCT01351025|Secondary|Number of Participants With Safety Endpoints After Study Treatment Cross-over (Week 24 to Week 48)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events after study treatment cross-over (week 24 to week 48).~The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 24 to week 48|participants who crossed over study treatment at week 24||participants|||Number
47647|NCT01351025|Secondary|Number of Participants With Safety Endpoints Before Study Treatment Cross-over (Baseline to Week 24)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events prior to study treatment cross-over (baseline to week 24).~The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 0 to week 24|participants who started study treatment||participants|||Number
47648|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD163 (log10 Transformed)|"CD163 (Cluster of Differentiation 163) is a protein that in humans encoded by the CD163 gene; and sCD163 is soluble CD163.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/ml||Inter-Quartile Range|Median
47649|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in P-selectin (log10 Transformed)|"P-selectin is a protein that in humans encoded by the SELP gene. P-selectin functions as a cell adhesion molecule (CAM) on the surfaces of activated endothelial cells, which line the inner surface of blood vessels, and activated platelets.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/ml||Inter-Quartile Range|Median
47650|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD14 (log10 Transformed)|Soluble cluster of differentiation 14 (sCD14) is a human gene. Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline].|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/ml||Inter-Quartile Range|Median
47651|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in CD40L (log10 Transformed)|"Cluster of differentiation 40 (CD40L) is a costimulatory protein found on antigen presenting cells and is required for their activation.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/ml||Inter-Quartile Range|Median
47652|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in IP-10 (log10 Transformed)|"IFN-gamma-inducible protein 10 (IP-10 or CXCL10) is a chemokine secreted from cells stimulated with type I and II IFNs and LPS, is also a chemoattractant for activated T cells.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/ml||Inter-Quartile Range|Median
47653|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in MCP-1 (log10 Transformed)|"Monocyte chemoattractant protein-1 (MCP-1/CCL2) is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/ml||Inter-Quartile Range|Median
47654|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD8+ T-cell Activation Percent|CD8+ T-cell activation percent (% CD38+/DR+ of CD8+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||percent||Inter-Quartile Range|Median
47655|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 D-dimer|D-dimer in log10 ng/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 ng/mL||Inter-Quartile Range|Median
51758|NCT01300247|Secondary|Percentage of Participants Who Were Alive||Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.||percentage of participants|||Number
47656|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD4+ T-cell Activation Percent|CD4+ T-cell activation percent (% CD38+/DR+ of CD4+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||percent||Inter-Quartile Range|Median
47657|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 IL-6|IL-6 (Interleukin 6) in log10 pg/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.||log10 pg/mL||Inter-Quartile Range|Median
47658|NCT01350999|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol|Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47659|NCT01350999|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47660|NCT01350999|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47661|NCT01350999|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47662|NCT01350999|Secondary|Percent Change From Baseline in Triglyceride Level||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set (all participants who were randomized and received at least one dose of the investigational product) with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47663|NCT01350999|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47664|NCT01350999|Primary|Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47665|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47666|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47667|NCT01350999|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47668|NCT01350973|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47669|NCT01350973|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47670|NCT01350973|Secondary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47671|NCT01350973|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.||participants|||Number
47672|NCT01350973|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time|The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47673|NCT01350973|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time|The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47674|NCT01350973|Secondary|Percent Change From Baseline in Total Cholesterol Over Time|The percentage change between total cholesterol measured at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47675|NCT01350973|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time|The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."||percent change||Standard Deviation|Mean
47677|NCT01350973|Primary|Percent Change From Baseline in Triglyceride Level at the Final Visit|The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.|Baseline and 12 weeks|Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data.||percent change||Standard Error|Least Squares Mean
47678|NCT01350947|Primary|Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.|Complete Hematologic Response is defined as: bone marrow evaluation shows <= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts|24 months|||percentage of patients|||Number
47679|NCT01350934|Other Pre-specified|Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12|"The term vitamin D insufficiency is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D <20 ng/mL."|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.||Percentage of Participants|||Number
47680|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-CTx at Month 12|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
47681|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-P1NP at Month 12|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
47682|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
47683|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.||Percent change||95% Confidence Interval|Least Squares Mean
47684|NCT01350934|Primary|Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12|BMD at the lumbar spine was assessed by DXA at baseline and Month 12.|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
47685|NCT01350934|Primary|Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6|BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.|Baseline and Month 6|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
47686|NCT01350804|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data|Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||mm/hr||Standard Deviation|Mean
47687|NCT01350804|Secondary|Change From Baseline in hsCRP - Observed Data|Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||mg/L||Standard Deviation|Mean
47902|NCT01347840|Secondary|Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)|These variables will measure the combined effects of hormone concentration and duration.|16 months|||units on a scale|||Number
47688|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Deviation|Mean
47689|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups||score on a scale||Standard Error|Least Squares Mean
47690|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Observed Data|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation."|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Deviation|Mean
47691|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)|"The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for this analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups.||score on a scale||Standard Error|Least Squares Mean
47692|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||Percentage of participants|||Number
47693|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. Participants with missing data were considered non-responders at the respective time point. Placebo and Abatacept participants were considered non-responders from the time of treatment switch.||Percentage of participants|||Number
47707|NCT01350414|Secondary|Respiratory Adverse Events|Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the “Respiratory System” that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage subjects with respiratory AE||95% Confidence Interval|Number
47694|NCT01350804|Secondary|Percentage of Participants Achieving ACR50|ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||Percentage of participants|||Number
47695|NCT01350804|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Error|Least Squares Mean
47696|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||score on a scale||Standard Error|Least Squares Mean
47697|NCT01350804|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.||Percentage of participants|||Number
47698|NCT01350583|Secondary|Number of Participants With Improvement in Pain Indices|Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.|||||
47699|NCT01350583|Secondary|Percent of Patients Where Treatment Was Well Tolerated|Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.|||||
47700|NCT01350583|Primary|Percent of Patients With Improvement|Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.|4 weeks per participant|Results data was not calculated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.|||||
47701|NCT01350414|Secondary|Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage of change from Baseline||Standard Deviation|Mean
47702|NCT01350414|Secondary|Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage of change from Baseline||Standard Deviation|Mean
47703|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Number of Hospitalizations for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/subjects/year||95% Confidence Interval|Number
47704|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Proportion of subjects with hospitalizations for respiratory symptoms.|12 Month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage of subjects hospitalized||95% Confidence Interval|Number
47705|NCT01350414|Secondary|Emergency Room (ER) Visits for Respiratory Symptoms|Number of Emergency Room Visits for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/subject/year||95% Confidence Interval|Number
47708|NCT01350414|Secondary|Respiratory Adverse Events|Number of respiratory adverse events per subject per year. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the “Respiratory System” that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/number of subject/Year||95% Confidence Interval|Number
47709|NCT01350414|Secondary|Severe Exacerbations|Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Number of events/Number of subjects/Year||95% Confidence Interval|Number
47710|NCT01350414|Primary|Severe Exacerbations|"The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%.~Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02)."|12 month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.||Percentage subjects severe exacerbations||95% Confidence Interval|Number
47711|NCT01350388|Secondary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma hsCRP concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
47712|NCT01350388|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma IL-6 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
47713|NCT01350388|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma TNF-α concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
47714|NCT01350388|Primary|Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks|The percent difference in TGF-beta1 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
47715|NCT01350388|Primary|Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in adiponectin concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
47716|NCT01350388|Primary|Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in thiobarbituric acid reactive substance (TBARS) concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
47717|NCT01350271|Secondary|Faecal Egg Count Reduction 2 (FECR2)|FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up were included in the analysis||percentage of eggs excreted||Standard Deviation|Mean
47718|NCT01350271|Secondary|Faecal Egg Count Reduction 1 (FECR1)|FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow-up, were included in the analysis||percentage of eggs excreted|||Number
47719|NCT01350271|Primary|Cure Rate|Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up.||percentage of participants|||Number
47720|NCT01350258|Secondary|Overall Survival|To assess overall survival in patients undergoing HSCT treated on this trial.|At 1 and 3 years||||||
47721|NCT01350258|Secondary|Engraftment Rate and Lymphoid Reconstitution|To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial.|100 days post-transplant||||||
47722|NCT01350258|Secondary|GVHD Incidence and Severity|To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen using MEL for T cell tolerization as well as tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|At 1 and 3 years||||||
47723|NCT01350258|Secondary|Relapse Rate|To compare relapse rates in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|At 1 and 3 years||||||
47724|NCT01350258|Primary|Phase 2: Non-Relapse Mortality (NRM)|To evaluate the 100 day non-relapse mortality (NRM) rate in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|100 days post-treatment||||||
47725|NCT01350258|Primary|Phase 1: Defined Dose of Melphalan (MEL)|To define the dose of MEL required for the establishment of peripheral T cell tolerance with concomitant immune reconstitution.|100 days post-transplant||||||
47736|NCT01350115|Secondary|Measure: Disease Burden by BCC Tumor Counts|BCC tumor counts were performed separately for five body regions: head and neck, trunk back, trunk front (including axillae and groin), upper extremities and lower extremities (including buttocks). During the counting, the BCC tumors, were categorized upon inspection by their longest diameter measurement (<10 mm, 10-19 mm, 20-29 mm, and >+30mm), and also by the type of BCC (superficial, nodular, other). The counts for all of the BCC type and size categories were determined (or estimated if many small lesions) for each body region. The body region counts were summated to provide the overall BCC tumor count.|Baseline, day 85, and day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.||Number of BCC tumors|||Number
47737|NCT01350115|Secondary|Histological Clearance Assessment of Main Target BCCs|The main (and secondary, if appropriate) target BCC tumor area(s) was/were excised surgically and sent to a central laboratory for histological examination.|day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.||Percentage of participants|||Number
47738|NCT01350115|Primary|Clinical Clearance Assessment of Main Target Basal Cell Carcinomas (BCCs)|The clinical response of the main target (and secondary target, as appropriate) BCC(s) to treatment was evaluated using the following 6-point scale comparing the assessment at the visit to the clinical presentation at Baseline: 0 = Worsening, 1 = No change, 2 = Slight clearance (1-25% improvement), 3 = Moderate clearance (26-75% improvement), 4 = Marked clearance (76-99% improvement),5 = Complete clearance (100% improvement) Complete clearance was defined as no clinical residual signs of carcinoma, as evaluated by the Investigator at a post-Baseline visit, with the exception of post-inflammatory changes such as minimal residual erythema or residual hyper-pigmentation or hypo-pigmentation or residual scarring.|Day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.||Participants|||Number
47739|NCT01349959|Other Pre-specified|Gene Methylation Evaluated Using Quantitative Multiple Methylation-specific Polymerase Chain Reaction (QM-MSP)|Wilcoxon rank sum tests will be used to determine the association between azacitidine or entinostat exposure and methylation changes expressed as a categorical variable (i.e.: response or no response). Data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Up to 8 weeks||||||
47740|NCT01349959|Other Pre-specified|Feasibility of the Addition of Hormone Therapy, Evaluated by Calculating the Percentage of Patients With Disease Progression That go on to Receive Hormonal Therapy||Up to 3 years||||||
47741|NCT01349959|Other Pre-specified|Confirmed Response Rate to Azacitidine and Entinostat Plus the Addition of Hormone Therapy|Will be estimated in each cohort. All evaluable patients who receive hormonal therapy will be used for this analysis.|Up to 3 years||||||
47742|NCT01349959|Other Pre-specified|Circulating DNA Evaluated Using QM-MSP|Data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Up to 8 weeks||||||
47743|NCT01349959|Other Pre-specified|Change in Expression of Relevant Genes (e.g., ER Alpha and RAR Beta) Evaluated by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|To evaluate baseline and change in candidate gene re-expression such as ER re-expression in malignant tissue, the absolute difference between prior to and following combination therapy (i.e., at 8 weeks) will be estimated and the median difference will be reported. These data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Baseline to up to 8 weeks||||||
47744|NCT01349959|Secondary|Progression-free Survival|Estimated using the method of Kaplan-Meier.|At 6 months|||months||95% Confidence Interval|Median
47745|NCT01349959|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|Up to 3 years|||months||95% Confidence Interval|Median
47746|NCT01349959|Secondary|Clinical Benefit Rate Estimated by the Number of Patients Who Achieve a Confirmed Response Plus the Number of Patients Who Have Stable Disease for a Duration of at Least 6 Months Divided by the Total Number of Evaluable Patients|All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.|Up to 3 years||||||
47747|NCT01349959|Primary|Confirmed Response Rate (Complete or Partial Response Noted as the Objective Status on Two Consecutive Evaluations at Least 4 Weeks Apart) Assessed by RECIST|The proportion of successes will be estimated independently for each cohort by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 3 years|||Percentage of participants||95% Confidence Interval|Number
47748|NCT01349933|Secondary|Duration of Response||The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years||||||
47749|NCT01349933|Secondary|Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)||Up to 3 years||||||
47750|NCT01349933|Secondary|Progression-free Survival|Estimated using the method of Kaplan-Meier.|From registration to the first of either death due to any cause or progression, assessed up to 3 years||||||
47751|NCT01349933|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years||||||
47752|NCT01349933|Secondary|Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the severe or worse adverse events will be assessed, regardless of relationship to the study treatment.|Up to 30 days after completion of study treatment||||||
47786|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity||mIU/mL||95% Confidence Interval|Mean
47753|NCT01349933|Primary|Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart|Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|6 months|||percentage of participants|||Number
47754|NCT01349933|Primary|Proportion of Patients Alive and Progression-free|The primary endpoint of this trial is the proportion of patients alive and progression-free at 6 months. Progression status is evaluated using RECIST version 1.1. A Progression is defined as either: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (less than 1.0 cm short axis) and increased to greater than or equal to 1 cm short axis during follow up. Or, at least a 20% increase in sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes.|6 months|||participants|||Number
47755|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation|The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline, Week 6, Week 22|Participants who had both blinded and unblinded scores available for analysis.||Correlation coefficient||90% Confidence Interval|Number
47756|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers|Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)|Participants who had both baseline serum or stool measurements available for analysis.||Correlation coefficient||90% Confidence Interval|Number
47757|NCT01349920|Primary|Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22|To determine R^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R^2 at weeks 6 and 22 is approximately 0.7.|Baseline and Week 6 or 22|Participants who had a blinded CDEIS score and measurements for each of the biomarkers included in the models at both baseline and at Week 6 or 22.||Coefficient of Determination|||Number
47758|NCT01349920|Primary|Change From Baseline in REG3-A at Week 22|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for REG3-A at both baseline and at Week 22.||ng/mL||Standard Deviation|Mean
47759|NCT01349920|Primary|Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for REG3-A at both baseline and at Week 6.||ng/mL||Standard Deviation|Mean
47760|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 22|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for lipocalin-2 at both baseline and at Week 22.||ng/mL||Standard Deviation|Mean
47761|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 6|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for lipocalin-2 at both baseline and at Week 6.||ng/mL||Standard Deviation|Mean
47762|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 22|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for calprotectin at both baseline and at Week 22.||µg/g||Standard Deviation|Mean
47763|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 6|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for calprotectin at both baseline and at Week 6.||µg/g||Standard Deviation|Mean
47764|NCT01349920|Primary|Change From Baseline in Serum hsCRP at Week 22|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for hsCRP at both baseline and at Week 22.||mg/L||Standard Deviation|Mean
47765|NCT01349920|Primary|Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for hsCRP at both baseline and at Week 6.||mg/L||Standard Deviation|Mean
47787|NCT01349829|Secondary|Seroprotection at Month 7|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity||percentage of participants||95% Confidence Interval|Number
47766|NCT01349920|Primary|Change From Baseline in CDEIS Blinded Score at Week 22|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 22|Participants who had a blinded CDEIS score at both baseline and at Week 22.||Score on a scale||Standard Deviation|Mean
47767|NCT01349920|Primary|Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 6|Participants who had a blinded CDEIS score at both baseline and at Week 6.||Score on a scale||Standard Deviation|Mean
47768|NCT01349907|Secondary|Change From Baseline in PQ-LES-Q Overall Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week. Item 15, the PQ-LES-Q overall score, observed OC, is a global assessment of overall quality of life, and ranges from 1 to 5, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47769|NCT01349907|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., health, mood or feelings); item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant, OC is the sum of the rating assigned to each of the first 14 items, and ranges from 14 to 70, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47770|NCT01349907|Secondary|Percentage of Participants With a CGAS Score of Equal or Greater Than 70|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The percentage of participants with a score of 70 or greater, representing normal to superior social functioning, is shown.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
47771|NCT01349907|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). An improvement in function is represented by a change from baseline value that is positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47772|NCT01349907|Secondary|Percentage of Participants With Emergent Depression Based on CDRS-R|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Participants with a CDRS-R score of 40 or greater (whose baseline CDRS-R is less than 40) exhibit emergent depression, which is a strong indicator of the presence or potential for a major depressive disorder.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
47773|NCT01349907|Secondary|Percentage of CDRS-R Responders|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. A CDRS-R responder experiences a 50% or more decrease from baseline in CDRS-R total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
47788|NCT01349829|Secondary|Seroprotection at Month 6|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity||percentage of participants||95% Confidence Interval|Number
47774|NCT01349907|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7, and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47775|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)|The CGI-BP mania is a single value score OC for assessing mania, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47776|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)|The CGI-BP depression is a single value score OC for assessing depression, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47777|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)|The CGI-BP overall is a single value score OC for assessing overall bipolar illness, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47778|NCT01349907|Secondary|Time to Failure to Maintain Response in Y-MRS Total Score|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to failure is the number of days from first achieving a 50% or more decrease from baseline in Y-MRS total score to the first subsequent day of a less than 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment. Restricted to participants who were total Y-MRS 50% responders in base trial P06107.||Days||95% Confidence Interval|Median
47779|NCT01349907|Secondary|Time to First Total Y-MRS 50% Response|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to 50% response is the number of days on treatment to achieve a 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Days||95% Confidence Interval|Median
47780|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Responders|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A Y-MRS responder experiences a 50% or more decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
47781|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A remitter is a participant with a Y-MRS total score of 12 or lower.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Percentage of participants|||Number
47782|NCT01349907|Secondary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score|The Y-MRS assesses the severity of manic episodes by assigning a severity rating to each of 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight). Seven of the 11 items are rated on a scale of 0-4, and 4 of the items are rated on a scale of 0-8. The Y-MRS total score, observed cases (OC), the assessment closest to the scheduled assessment day within the allowed window, is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.||Score on a scale||Standard Deviation|Mean
47783|NCT01349907|Primary|Number of Participants Who Experienced Clinical or Laboratory Adverse Events|A clinical or laboratory adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)|Participants who received at least one dose of trial medication, and were 17 years old or younger. One treated participant from the Placebo/Asenapine group, who was 18 years old, was excluded from this analysis.||Participants|||Number
47856|NCT01348139|Secondary|Tmax:Time to Maximum Plasma Concentration|Time to maximum plasma concentration (tmax), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||Hours||Full Range|Median
47789|NCT01349829|Primary|Seroprotection at Month 1|Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity||percentage of participants||95% Confidence Interval|Number
47790|NCT01349803|Secondary|Mean Change From Baseline in QTcF Interval|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, Day 7, and Day 14|Safety Population||msec||Standard Deviation|Mean
47791|NCT01349803|Secondary|Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Tachycardia episodes / hour||Standard Error|Mean
47792|NCT01349803|Secondary|Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Bradycardia episodes / hour||Standard Error|Mean
47793|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Supraventricular runs / hour||Standard Error|Mean
47794|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Supraventricular couplets / hour||Standard Error|Mean
47795|NCT01349803|Secondary|Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Supraventricular events / hour||Standard Error|Mean
47796|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Ventricular runs / hour||Standard Error|Mean
47797|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Ventricular couplets / hour||Standard Error|Mean
47903|NCT01347840|Primary|Area Under the Curve of Ghrelin and GLP-1|These variables will measure the combined effects of hormone concentration and duration.|16 months|||units on a scale|||Number
47798|NCT01349803|Secondary|Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||Ventricular events / hour||Standard Error|Mean
47799|NCT01349803|Secondary|Change From Baseline in 24-Hour Minimum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
47800|NCT01349803|Secondary|Change From Baseline in 24-Hour Maximum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
47801|NCT01349803|Secondary|Change From Baseline in Night Time Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
47802|NCT01349803|Secondary|Change From Baseline in Daytime Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
47803|NCT01349803|Secondary|Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|24 hours|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
47804|NCT01349803|Secondary|Change From Baseline in Mean FEV1 Trough|Trough FEV1 averaged over Day 7 and Day 14|Day 7 to Day 14|MITT - patients from the ITT population who completed at least one evaluable FEV1 spirometry assessment for baseline (pre-dose on Day 1) and had an evaluable FEV1 spirometry assessment on at least one of the following: Day 7 pre-dose or Day 14 pre-dose (or both).||Liters||95% Confidence Interval|Least Squares Mean
47805|NCT01349803|Primary|Change From Baseline in 24-Hour Mean Heart Rate Post-dose|The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).|14 days|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.||bpm||95% Confidence Interval|Least Squares Mean
47806|NCT01349595|Primary|The Incidence of a Combined Endpoint of Death-censored Graft Loss or Greater Than 50% Reduction in Estimated Glomerular Filtration (eGFR) in Study Subjects.||60 months after enrollment in the study|Results data for zero participants were analyzed; long-term follow-up evaluation of participants was not possible due to discontinuation of funding.|||||
47807|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."||Percentage of participnats|||Number
47808|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."||Percentage of participants|||Number
47809|NCT01349465|Secondary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability||End of study (at month 36)|||Participants|||Number
47810|NCT01349465|Secondary|Percentage of Participants With Late Viral Relapse|Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.|End of study (at month 36)|Late viral relapse was evaluated in all enrolled participants with SVR at LPVPS.||percentage of participants|||Number
47811|NCT01349465|Primary|Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of participants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."||Percentage of participants|||Number
47812|NCT01349465|Primary|Percentage of Participants Maintaining SVR at the Last Available Visit|The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).|Last Available Visit (Month 36 for subjects completing the study)|All participants with SVR at LPVPS were included in the population analysis set.||Percentage of participants||95% Confidence Interval|Number
47813|NCT01349231|Secondary|Depression Symptoms|We will examine change from baseline in Hamilton Rating Scale for Depression (HRDS) ratings of depression severity at day 1-3 following a single ketamine infusion. The HRDS assesses severity of, and change in, depressive symptoms. The HRDS is a 21 item scale with scores ranging from 0-66. The higher the score, the more severe the depression.|Baseline, Day 1, Day 2, and Day 3|||units on a scale||Standard Deviation|Mean
47814|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 3 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 3 days following infusion|||units on a scale||Standard Deviation|Mean
47815|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 2 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 2 days following infusion|||units on a scale||Standard Deviation|Mean
47816|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 1 day following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 1 day after ketamine infusion|||units on a scale||Standard Deviation|Mean
47817|NCT01349114|Secondary|Mean Central Aortic Pressure at 3 Months|Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)|3 months after start of study|||mm Hg||Standard Deviation|Mean
47818|NCT01349114|Primary|Change in Flow-mediated Dilation|Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion|Baseline to 3 months|||percentage of flow-mediated dilation||Standard Deviation|Mean
47819|NCT01348854|Secondary|Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)||6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.||percentage of eyes|Participants||Number
47820|NCT01348854|Primary|Reduction of Astigmatism|Reduction of astigmatism as determined by manifest refractive cylinder|6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.||diopter|Participants|Standard Deviation|Mean
47821|NCT01348789|Secondary|Hair Clearance|Hair Clearance = the percent of hair cleared from baseline to follow up|8 weeks after last treatment|||%baseline hair count|Participants|Standard Deviation|Median
47822|NCT01348789|Secondary|Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.|Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)|0, 3, 7 days (after treatment #1, #2, and #3 respectively)|||number of areas|Participants||Number
47857|NCT01348139|Secondary|AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),|Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||nmol*h/L||Standard Deviation|Mean
47823|NCT01348789|Primary|Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.|"The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes:~Presence of transient (disappearing < 24 hours) or prolonged erythema~Presence of transient (disappearing < 24 hours) or prolonged edema~Self-limited bleeding from mechanical shaving~Blister formation~Ulcer formation~Pigment changes (hypo/hyper)~Textural changes~Scarring~Infection~Pruritis~Post inflammation reactions~Allergic reaction~The safety of the device will be confirmed if no device related serious adverse event will occur."|Up to 3 months|Intention to treat analysis - all participants that received at least 1 treatment.||percentage of particpants||95% Confidence Interval|Number
47824|NCT01348776|Secondary|Subject Satisfaction|Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.|5 months (final follow up)|Two subjects did not report on satisfaction.||participants|||Number
47825|NCT01348776|Secondary|Tolerability Level of the Procedure Following Treatments|"Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]) .~The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated."|1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)|||% treated areas|Participants||Number
47826|NCT01348776|Secondary|Occurrence of Anticipated Effects on Skin|As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.|Up to 19 weeks|||Number of reports|Participants||Number
47827|NCT01348776|Secondary|Hair Clearance at 3-month (Final) Follow up|Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.|5 months (3 months after 7 weekly treatments)|All areas with photos that allowed reliable hair counting were included for this analysis.||%baseline hair count|Participants|Standard Error|Mean
47828|NCT01348776|Primary|Hair Clearance 1 Month After Last Treatment|Hair clearance = the percent of hair cleared from baseline to endpoint.|3 months (1 month after 7 weekly treatments)|Sample size was discussed with the FDA during a pre-IDE meeting.||%baseline hair count|Participants|Standard Deviation|Mean
47829|NCT01348607|Secondary|Adverse Events|Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.|29 days|||events|||Number
47830|NCT01348607|Primary|Average Daytime Napping Minutes in a Week|Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries|29 days|||minutes||Standard Deviation|Mean
47831|NCT01348425|Primary|Percent Change in Stent Length Upon Deployment||During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)|||Change in stent length (%)||Standard Deviation|Mean
47832|NCT01348165|Primary|Assessment of Tolerability by Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories ‘good’, ‘satisfactory’, ‘not satisfactory’, and ‘bad’.|28 days|Treated Set||Participants|||Number
47833|NCT01348165|Primary|Body Temperature|Change from baseline to 28 Days in Body temperature|Baseline and 28 days|Treated Set||degrees celcius||Standard Deviation|Mean
47834|NCT01348165|Secondary|Minimum Effect (Emin)|Minimum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
47835|NCT01348165|Secondary|Maximum Effect (Emax)|Maximum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
47836|NCT01348165|Secondary|Area Under the Effect Curve (AUEC)|Area under the effect curve for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. Geometric mean and geometric coefficient of variation was not calculated for any parameter in any dose group in which zero or a negative value was calculated, as geometric means cannot be calculated with negative or zero values.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
47837|NCT01348165|Secondary|Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.|Percent of inhibition of fMLP induction of LTB4 production. Concentrations of LTB4 in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Results indicate percent change from baseline of fMLP induction of LTB4 production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||percentage of LTB4 production||Standard Deviation|Mean
47858|NCT01348139|Secondary|Cmax: Maximum Plasma Concentration|Maximum plasma concentration (Cmax) for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||nmol/L||Standard Deviation|Mean
47859|NCT01348139|Secondary|E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit|Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set||Beats/min||Standard Deviation|Mean
47860|NCT01348139|Secondary|Emax: Maximum Value of Pulse for Every Treatment Visits|Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set||Beats/min||Standard Deviation|Mean
47838|NCT01348165|Secondary|Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo|Concentrations of TNF-α in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Concentrations of TNF-α in blood drawn after treatment with BI 137882 were compared with those in pre-dose samples to calculate the percent of inhibition of LPS induction of TNF-α production. Results indicate percent change from baseline of LPS-induced TNF-α production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.||percentage of TNF-α production||Standard Deviation|Mean
47839|NCT01348165|Secondary|Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2|Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.|||||
47840|NCT01348165|Secondary|Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2|Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.|||||
47841|NCT01348165|Secondary|Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2|Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.|||||
47842|NCT01348165|Secondary|Apparent Volume of Distribution (Vz/F)|Apparent volume of distribution of the analyte during the terminal phase.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||L||Geometric Coefficient of Variation|Geometric Mean
47843|NCT01348165|Secondary|Apparent Clearance (CL/F)|Apparent clearance of the analyte in plasma after extravascular administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||mL/min||Geometric Coefficient of Variation|Geometric Mean
47844|NCT01348165|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
47845|NCT01348165|Secondary|Terminal Rate Constant (λz)|Terminal rate constant in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||1/h||Geometric Coefficient of Variation|Geometric Mean
47846|NCT01348165|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
47847|NCT01348165|Secondary|Terminal Half-life (t1/2)|Terminal half-life of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
47848|NCT01348165|Secondary|Area Under the Curve 0 to Infinity (AUC0-infinity)|Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
47849|NCT01348165|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration of the analyte in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||hours||Full Range|Median
47850|NCT01348165|Secondary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
47851|NCT01348165|Primary|Respiratory Rate (RR)|Change from Baseline to 28 Days in Respiratory rate (RR)|Baseline and 28 days|Treated Set||breaths/min||Standard Deviation|Mean
47852|NCT01348165|Primary|Pulse Rate (PR)|Change from Baseline to 28 Days in Pulse Rate|Baseline and 28 days|Treated Set||bpm||Standard Deviation|Mean
47853|NCT01348165|Primary|Blood Pressure|Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Baseline and 28 days|Treated Set||mmHg||Standard Deviation|Mean
47854|NCT01348165|Primary|Number of Subjects With Drug Related Adverse Events|Number of subjects with drug related adverse events (AEs)|From baseline up to 28 days|Treated Set which included all subjects who received one dose of trial medication||Participants|||Number
47855|NCT01348139|Secondary|t1/2 :Terminal Half-life|Terminal half-life (t1/2),for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set||Hours||Standard Deviation|Mean
47866|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone Divided by Dose - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL/mg||Standard Deviation|Mean
47867|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng*h/mL||Standard Deviation|Mean
47868|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
47869|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||hours||Full Range|Median
47870|NCT01348100|Secondary|Duration That the Concentration of Iloperidone Was Above 4 ng/mL (Teff) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The duration that the concentration of iloperidone was above 4 ng/mL was calculated by linear interpolation. PK/pharmacodynamic analysis performed in other studies suggests that iloperidone plasma levels of 4 ng/mL or above provide clinical efficacy.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||hours||Full Range|Median
47871|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
47872|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng*h/mL||Standard Deviation|Mean
47873|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng*h/mL||Standard Deviation|Mean
47874|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
47875|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||hours||Full Range|Median
47876|NCT01348100|Primary|The Average Plasma Concentration (Cav) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||ng/mL||Standard Deviation|Mean
47904|NCT01347840|Primary|Resting Energy Expenditure|Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.|16 months|||units on a scale|||Number
47877|NCT01348100|Primary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.||Ratio of Cmax to Cav||Standard Deviation|Mean
47878|NCT01348087|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).|Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which patients entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study. AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 patients are shown under (‘Prior to Ext. first dose’). AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure||Participants|||Number
47879|NCT01347931|Secondary|Borg Dyspnea Score|"Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from:~0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome"|Measured during activity testing in a single day study visit|Per Protocol||units on a scale||95% Confidence Interval|Median
47880|NCT01347931|Secondary|Arterial Oxygen Saturation|O2 saturation measured by pulse oximetry|Measured during activity testing in a single day study visit|Per Protocol||percentage of oxyHb saturation||Standard Deviation|Mean
47881|NCT01347931|Primary|Activity Endurance Time|Time in minutes of sustained activity while using test treatments|Measured during single day study visit|Per Protocol||minutes||Standard Deviation|Mean
47882|NCT01347879|Secondary|Severe and Very Severe Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.||participants|||Number
47883|NCT01347879|Secondary|Mild and Moderate Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.||participants|||Number
47884|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.||participants|||Number
47885|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.||participants|||Number
47886|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment|||participants|||Number
47887|NCT01347879|Secondary|Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after first treatment|||percent change||Full Range|Median
47888|NCT01347879|Secondary|Clear and Almost Clear Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.||participants|||Number
47889|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment|||participants|||Number
47890|NCT01347879|Secondary|Number of Patients With Adverse Events.||From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration|||participants|||Number
47891|NCT01347879|Secondary|Pain During Illumination.|Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.|Immediately after first treatment|||VAS score in cm||Full Range|Mean
47892|NCT01347879|Secondary|Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.|One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.|From baseline to 12 weeks after first treatment|||participants|||Number
47893|NCT01347879|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.||From baseline to 12 weeks after the first treatment|||percent change||Full Range|Median
47894|NCT01347879|Secondary|Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after the first treatment|||lesion count||Standard Deviation|Mean
47895|NCT01347879|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).||From baseline to 12 weeks after first treatment|||lesion count||Standard Deviation|Mean
47905|NCT01347840|Primary|Percent Excess Weight Loss|Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.|16 months|||percentage of excess weight|||Number
47906|NCT01347788|Primary|Partial Response in Bone Scan From Baseline to Week 6|Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.|Baseline and Week 6|||participants|||Number
47907|NCT01347710|Secondary|Diagnostic Certainty in PET MPI and SPECT MPI|Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of patients|||Number
47908|NCT01347710|Secondary|Image Quality of Rest and Stress (PET vs SPECT).|Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||percent of images|||Number
47909|NCT01347710|Secondary|Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good|Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
47910|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity|Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard|60 days|all safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data and had evaluable invasive coronary angiography||Proportion of true negatives||95% Confidence Interval|Number
47911|NCT01347710|Secondary|Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good|Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true positives||95% Confidence Interval|Number
47912|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
47913|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true positives||95% Confidence Interval|Number
47914|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).|Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
47915|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).|Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 Flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||Proportion of true positives||95% Confidence Interval|Number
47916|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography||proportion of true negatives||95% Confidence Interval|Number
47917|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|"Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard~I"|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography||proportion of true postives||95% Confidence Interval|Number
47918|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity|Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography||Proportion of true positive cases||95% Confidence Interval|Number
47919|NCT01347632|Primary|p24 Antigen Concentration ng/mL|"The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:~During a BV infection~Approximately 1 week after completing a 7-day course of metronidazole therapy~Approximately 1 month after completing the 7-day course of metronidazole therapy~You will not come in contact with HIV during this study - only your samples (after we have removed them from your vagina/cervix) come in contact with HIV."|6 weeks|||ng/mL||95% Confidence Interval|Mean
47920|NCT01347580|Secondary|Minor and Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition)|after 48 hours post first dose|safety||patients|||Number
47921|NCT01347580|Secondary|Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition) include life threatening and other major bleedings|after 48hours post-first dose|safety||patients|||Number
47922|NCT01347580|Secondary|Minor and Major Bleedings Within 48 Hours|non CABG related bleeds (PLATO definition)|within 48 hours of first dose|Safety||patients|||Number
47923|NCT01347580|Secondary|Major Bleeds Within 48 Hours|non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds|within 48 hours of first dose|Safety||patients|||Number
47924|NCT01347580|Secondary|Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI|Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.|during PCI|mITT||patients|||Number
47925|NCT01347580|Secondary|ST Segment Elevation Resolution Post-PCI >= 70%|ST segment elevation resolution post PCI >=70% is defined as complete resolution|Between baseline and ECG 60 mn post-PCI|mITT on patients with non missing ECG values||patients|||Number
47926|NCT01347580|Secondary|TIMI Flow Grade 3 Post -PCI|TIMI) flow grade 3 is complete perfusion post-PCI.|at coroangiography post-PCI|mITT, on patients with non missing TIMI flow grade values||patients|||Number
47927|NCT01347580|Secondary|Definite Stent Thrombosis|Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint|during 30 days of treatment|mITT||patients|||Number
47928|NCT01347580|Secondary|2nd Composite Clinical Endpoint|Death/MI/urgent revascularization. Adjudicated events except death|within 30 days of study|mITT||patients|||Number
47929|NCT01347580|Secondary|1st Composite Clinical Endpoint|death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death|during the 30 days of treatment|mITT||patients|||Number
47930|NCT01347580|Primary|ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)|ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.|Between baseline and PCI|mITT, on patients with non missing values||patients|||Number
47931|NCT01347580|Primary|Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)|(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.|At initial angiography, pre PCI|mITT, on patients with non missing values||patients|||Number
47932|NCT01347554|Secondary|Any Bleeding||Two year|||participants|||Number
47933|NCT01347554|Secondary|Stent Thrombosis|Definite and probable stent thrombosis|Two years|||participants|||Number
47934|NCT01347554|Secondary|Device-oriented Composite Outcome|defined as a composite of all-cause mortality, any MI (includes non-target vessel territory) and repeat revascularization (includes all target and non-target vessel)|Two years|||participants|||Number
47935|NCT01347554|Primary|Device-oriented Composite Outcome|defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization|Two year|||participants|||Number
47936|NCT01347255|Secondary|Changes in Total Skin Thickness|Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline|Baseline and Days 8, 15, 22, and 29.|||millimetres||Standard Deviation|Mean
47937|NCT01347255|Secondary|Change From Baseline in Echo-poor Band Thickness at End of Treatment|Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound|Baseline and Day 29|||millimetres||Standard Deviation|Mean
47938|NCT01347255|Secondary|Changes in Total Clinical Score (TCS) by Visit|Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.|Baseline and Days 4, 8, 11, 15, 18, 22, 25|||Scores on a scale||Standard Deviation|Mean
47939|NCT01347255|Secondary|Change in Clinical Sign Scores|"Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline.~The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)).~Negative changes in mean score represent improvement."|Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)|||units on a scale||Standard Deviation|Mean
47940|NCT01347255|Primary|Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline|TCS range from 0 (all signs absent) to 9 (all signs severe).|Day 1 (Baseline)/Day 29|Intra-individual analysis population||Scores on a scale||Standard Deviation|Mean
47941|NCT01347112|Secondary|Heavy Drinking Days at End of Treatment|Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method.|week 12|||days||Standard Deviation|Mean
47942|NCT01347112|Secondary|Prolonged Abstinence at 24 Weeks|Prolonged abstinence is identified by a negative response to the question, “Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”|week 24|||participants|||Number
47943|NCT01347112|Primary|Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment|"Prolonged smoking abstinence will be identified by a negative response to the question, Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”"|12 weeks|||participants|||Number
47944|NCT01347086|Secondary|Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide).~The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
47945|NCT01347086|Secondary|Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
47946|NCT01347086|Secondary|AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168 Acylglucuronide) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg, Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
47947|NCT01347086|Secondary|Cmax of CD 6168 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
47948|NCT01347086|Secondary|Tmax of CD 6168 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
47949|NCT01347086|Secondary|AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
47950|NCT01347086|Secondary|Cmax of BI 208333 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (BI 208333).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
47951|NCT01347086|Secondary|Tmax of BI 208333 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) .|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
47952|NCT01347086|Secondary|AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (BI 208333) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
47953|NCT01347086|Secondary|Cmax of Deleobuvir|Maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||µmol/L||Geometric Coefficient of Variation|Geometric Mean
47954|NCT01347086|Secondary|Tmax of Deleobuvir|Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.||h||Full Range|Median
47955|NCT01347086|Secondary|AUC0-∞ of Deleobuvir|Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration|The pharmacokinetic (PK) analysis set: all evaluable subjects of the treated set who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
47981|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination|To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.|Day 1, Day 29|Analysis was done on the FAS (Persistence).||Titers||95% Confidence Interval|Geometric Mean
47956|NCT01347086|Primary|Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|"Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint.~New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure)."|From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.|The treated set.||participants|||Number
47957|NCT01347086|Primary|Number of Subjects With Drug Related Adverse Events|"Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint.~The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history."|From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.|Treated set (full analysis set according to the International Conference on Harmonization (ICH) E9 guideline): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.||Participants|||Number
47958|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Safety Extension portion of the protocol ( please note: HPN-100 treatment only during Safety Extension )|12 months|All patients that entered the Safety Extension were included in the analysis of adverse events||participants|||Number
47959|NCT01347073|Secondary|Hyperammonemic Crisis|Rate of HAC during pre-enrollment on NaPBA compared to HAC during HPN-100 treatment|1 year|||number of crises|||Number
47960|NCT01347073|Secondary|Frequency of Ammonia Levels Greater Than the Upper Limit of Normal (ULN) on HPN-100 Compared With NaPBA|Ammonia values were converted to SI units (umol/L) and normalized to a standard ULN of 35 umol/L prior to analysis|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.||Ammonia Values > ULN|Ammonia Values||Number
47961|NCT01347073|Secondary|Blood Ammonia|24-hour ammonia AUC of blood ammonia levels on Days 1 (NaPBA) and 10 (HPN-100) were compared. Ammonia was assessed at Hour 0 (pre-first dose, fasted), Hour 8 (~2-4 hours after lunch or the second main meal and dose of NaPBA), Hour 12 (~4 hours after the last main meal) and 24 hours post-first dose (pre-first dose on following day, fasted).|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.||umol/L*hours||Standard Deviation|Mean
47962|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Switch-Over portion of the Protocol|2 weeks|All patients who received any amount of study medication were included in this population, which is the primary population for all baseline, accountability, demographic and safety analyses.||participants|||Number
47963|NCT01347060|Secondary|Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant|The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.||albuterol canisters||Standard Deviation|Mean
47964|NCT01347060|Secondary|Mean Asthma-related Costs in the Post-index Period|Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.||United States dollars||Standard Deviation|Mean
47965|NCT01347060|Primary|Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims|Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.||Asthma-related events||Standard Deviation|Mean
47966|NCT01347034|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)|Evaluate the safety of intratumoral injections of DCs in combination with an intensified RT regimen patients with high-grade large STS. Toxicity assessments were performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention was paid to DC injection and biopsy related toxicity. Only treatment related SAEs and AEs are reported for this measure.|11 weeks per participant|All participants||participants|||Number
47982|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains|The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.|Day 50, Day 209|Subjects aged 6 through <72 months of age - Full Analyses Set (FAS) Persistence||Percentage of subjects||95% Confidence Interval|Number
47967|NCT01347034|Primary|Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)|Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. Criteria for immune response evaluation: Individual patients were considered as responders to TAAs if at any time point the response in IFN-γ ELISPOT assay was found higher than 30 spots per 200,000 cells or in proliferation assay higher than 3000 counts/min (CPM) AND the response in IFN-γ ELISPOT or proliferation assays to tumor cell lysates (TCL) or Ad-Surv was found more than 2SD higher than the response to corresponding control lysate or Ad-c at the same time point AND 2SD higher than the response to the same stimuli at a base line (before start of the treatment).|11 weeks per participant|All participants||participants|||Number
47968|NCT01347008|Secondary|Daily Frequency of Raynaud's Phenomenon Attacks|Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit.|8 weeks|||number of attacks per day||Standard Deviation|Mean
47969|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.||8 weeks|||perfusion units||Standard Deviation|Mean
47970|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus|Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).|8 weeks|||perfusion units||Standard Deviation|Mean
47971|NCT01346852|Secondary|Mean Number of Short-acting Beta-agonist (SABA) Canisters Used|The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=1 albuterol canister dispensed during the 12-month pre-index period.||canisters||Standard Deviation|Mean
47972|NCT01346852|Primary|Mean Ratio of Controller Medication to Total Asthma Medication|The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=5 albuterol canisters dispensed identified in the database during the 12-month identification period (pre-index). We tested 3 different capture/follow-up periods; thus, sample sizes varied depending capture period used.||ratio||Standard Deviation|Mean
47973|NCT01346839|Secondary|Trigger Positive Predictive Value|Positive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.|15 months|||Percentage of participants|||Number
47974|NCT01346839|Secondary|Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation|Subsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.|15 months|||Number of patients diagnosed with cancer|||Number
47975|NCT01346839|Secondary|Percentage of Cases With no Documented Justification for no Follow-up|This is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.|15 months|||percentage with no documentation|||Number
47976|NCT01346839|Secondary|Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer|The percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.|15 months|||percentage of follow-up|||Number
47977|NCT01346839|Primary|Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer|Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.|15 months|||Days||Inter-Quartile Range|Median
47978|NCT01346774|Primary|Participants With Clinically-diagnosed and Treated UTI's.|The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records.|From surgery to post-op visit, approximately 6 weeks post surgery|Analysis was run on all 160 subjects that were ascribed to an arm of the study. Data were analyzed using an intent to treat protocol.||participants||95% Confidence Interval|Number
47979|NCT01346592|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).|Day 1 to Day 394|Analysis was done on the safety population i.e all subjects who had received at least one study vaccine and had postvaccination safety data||Participants|||Number
47980|NCT01346592|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination|The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.|Day 1 through Day 7 after any vaccination|Analysis was done on solicited safety set i.e all subjects who had received at least one study vaccine and had provided data on post vaccination solicited AEs||Participants|||Number
48005|NCT01346397|Primary|Graft Survival|in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%|5 years|||percentage of participants||95% Confidence Interval|Number
47983|NCT01346592|Secondary|The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)|The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 50, Day 209|Analysis was done on the FAS Persistence||Titers||95% Confidence Interval|Geometric Mean
47984|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
47985|NCT01346592|Secondary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the Full Analysis Set.||Percentages of subjects||95% Confidence Interval|Number
47986|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.|Day 50|Analysis was done on the Per Protocol Set.||Percentages of subjects||95% Confidence Interval|Number
47987|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the PPS.||Titers||95% Confidence Interval|Geometric Mean
47988|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains|The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)||Percentage of subjects||95% Confidence Interval|Number
47989|NCT01346592|Secondary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group|The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)||Percentage of subjects||95% Confidence Interval|Number
47990|NCT01346592|Secondary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)||Ratios||95% Confidence Interval|Geometric Mean
47991|NCT01346592|Secondary|The HI GMTs Against Homologous Strains, by Vaccine Group|The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence) i.e. all subjects in the enrolled population who actually received a study vaccination, and provided evaluable serum samples at all relevant timepoints and also at day 209.||Titers||95% Confidence Interval|Geometric Mean
47992|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS||Percentage of subjects||95% Confidence Interval|Number
47993|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the FAS||Titers||95% Confidence Interval|Geometric Mean
47994|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS||Percentage of subjects||95% Confidence Interval|Number
47995|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Full Analysis Set (FAS) i.e all enrolled subjects who received study vaccination and provided serum samples.||Titers||95% Confidence Interval|Geometric Mean
47996|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age|The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Subjects aged 6 through <36 months of age - Per Protocol Set (PPS).||Percentage of subjects||95% Confidence Interval|Number
47997|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)|The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to <36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the PPS.||Titers||95% Confidence Interval|Geometric Mean
47998|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains|"The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 50|Analysis was done on the PPS.||Percentage of subjects||95% Confidence Interval|Number
47999|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Per Protocol Set (PPS) i.e all subjects in the enrolled population who correctly received the study vaccine, provided evaluable serum samples at relevant time-points and had no major protocol violations as defined prior to unblinding.||Titers||95% Confidence Interval|Geometric Mean
48000|NCT01346501|Secondary|Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions|Adverse drug reactions (serious and non-serious) are adverse events for which the causal relationship between adalimumab and the event could not be ruled out. Adverse event was defined as any untoward or unintended medical occurrences (including abnormal laboratory findings), signs/symptoms, or diseases of the participant receiving adalimumab, regardless of causality of adalimumab treatment. Data are presented as percentage of participants.|From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years|Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.||Percentage of participants|||Number
48001|NCT01346501|Secondary|Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5|The mTSS, a method of assessing radiographs, was used to evaluate the level of joint destruction by disease. Digitized X-rays of hands and feet were obtained and scored on a scale ranging from 0 [no damage] to 5 [complete collapse or total destruction of joint] for erosion and 0 [no damage] to 4 [complete luxation of joint] for joint space narrowing. The scores on each task were summed and averaged to derive the total mTSS score ranging from 0 [normal] to 380 [maximal disease]. Large positive change in mTSS indicated disease progression; small positive/no change indicated slowing/halting of disease progression. The mTSS score ≤ 0.5 was defined as minimal radiographic progression. Data are presented as the percentage of the participants with mTSS ≤ 0.5 and ≤ 1.5 at the end of third year of the observation period (at Week 104 of P12-707).|3 years|The effectiveness analysis set was defined as all participants who had evaluable mTSS score during studies P12-069 and P12-707.||Percentage of participants|||Number
48002|NCT01346501|Primary|Mean Health Assessment Questionnaire (HAQ) Score|The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable HAQ score during studies P12-069 and P12-707.||Score on a scale||Standard Deviation|Mean
48003|NCT01346501|Primary|Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)|MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level < 121 ng/mL in men and < 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable MMP-3 score during studies P12-069 and P12-707.||Percentage of participants|||Number
48004|NCT01346501|Primary|Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment|The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score <3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score < 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156|The effectiveness analysis set was defined as all participants who had evaluable DAS28-CRP score during studies P12-069 and P12-707.||Percentage of participants|||Number
48007|NCT01346293|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference >50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 28 post-final vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Participants|||Number
48008|NCT01346293|Other Pre-specified|Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
48009|NCT01346293|Other Pre-specified|Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.||Participants|||Number
48010|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.||Participants|||Number
48011|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.||Participants|||Number
48012|NCT01346293|Primary|Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
48013|NCT01346293|Primary|Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration <1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.||Participants|||Number
48014|NCT01346293|Primary|Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
48015|NCT01346293|Primary|Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration <0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but <2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.||Participants|||Number
48016|NCT01346293|Primary|Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
48017|NCT01346293|Primary|Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Booster responses to pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but <4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.||Participants|||Number
48045|NCT01345721|Primary|Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination|The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.|1 month post booster vaccination|The analysis was done on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
48018|NCT01346176|Secondary|Patient Satisfaction With Advance Care Planning.|Patients’ satisfaction with their advance care planning was assessed two months after they completed their ADs. One of two authors blinded to patients’ group assignments contacted patients by phone and administered a satisfaction survey based on the Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This thirteen-item questionnaire has been validated for assessing satisfaction with end-of-life care planning. Patients were asked to indicate satisfaction with various parts of advance care planning (e.g. decisions about the use of life sustaining technologies including CPR or cardiopulmonary resuscitation, breathing machines, and dialysis) on a scale from 1 to 5, where 1 means not at all satisfied and 5 means completely satisfied. The overall average across the 13 item scale in each group is presented in the results below.|Two months after AD completion|These numbers reflect the number of patients who completed and returned and advance directive as well as completed a satisfaction interview and questionnaire with a research associate.||units on a scale||Full Range|Mean
48019|NCT01346176|Primary|Proportion of Subjects Who Select Palliative Care Options|The primary outcome variable will be the proportion of subjects that select palliative care options compared to the those who request aggressive treatment in each study arm. We will analyze the effects of manipulating default options and delays in alerting subjects to the presence of multiple default options on each selection in the ADs in order to see how default options influence decisions on general treatment goals and instructions for specific procedures.|6 months|This number was based on the number of participants who returned completed advance directive forms in each group||percentage who select palliative care||95% Confidence Interval|Number
48020|NCT01346085|Secondary|Any Adverse Event Throughout Follow-up|Among study participants there were no reports of death, post-transplantation lymphoproliferative disease, cancer, or opportunistic infections. There was no evidence of cytomegalovirus disease, infection or serological activation (CMV early antigens negative during the whole follow-up), nor of Epstein–Barr clinical and serological reactivation (all patients were antibodies anti EBV positive before transplant, as per the inclusion criteria).|up to 3 years||||||
48021|NCT01346085|Secondary|Severe Hypoglycemic Events Since Completion of Transplant||up to 3 years||||||
48022|NCT01346085|Secondary|the Reduction in Insulin Requirement Compared to Baseline||up to 3 years||||||
48023|NCT01346085|Secondary|Basal and Stimulated Blood C-peptide Levels in Response to Arginine Challenge Throughout Follow-up||up to 3 year||||||
48024|NCT01346085|Secondary|Glycated Hemoglobin Levels Throughout Follow-up||up to 3 years||||||
48025|NCT01346085|Secondary|Insulin Independence With Adequate Glycemic Control Throughout Follow-up||up to 3 years|||participants|||Number
48026|NCT01346085|Primary|The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion|Insulin independence is defined as no need for exogenous insulin, with adequate glycemic control [i.e., glycated hemoglobin <7% (normal range 3.5 - 6.0%), fasting glucose levels not exceeding 140 mg/dL (7.8 mmol/L) more than three times per week and 2-hour postprandial levels not exceeding 180 mg/dL (10 mmol/L) more than four times per week].|3 year|||participants|||Number
48027|NCT01345929|Secondary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|ME: Treated patients, with baseline pathogen, complied with protocol.||percentage of subjects|||Number
48028|NCT01345929|Primary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|mMITT: Treated subjects, with baseline pathogen.||percentage of subjects|||Number
48029|NCT01345786|Secondary|Volume of Distribution (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||L|Participants|Standard Deviation|Mean
48030|NCT01345786|Secondary|Clearance (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||L/h|Participants|Standard Deviation|Mean
48031|NCT01345786|Secondary|t1/2 of E2||0 hours to t1/2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Mean
48032|NCT01345786|Secondary|Terminal Phase Half Life (t1/2) of NOMAC||0 hours to t1/2 (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Mean
48033|NCT01345786|Secondary|Tmax of E2||0 hours to tmax of E2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Median
48034|NCT01345786|Secondary|Tmax of NOMAC||0 hours to tmax of NOMAC (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||hours|Participants|Full Range|Median
48035|NCT01345786|Primary|Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~AUC72 is the AUC from time 0 to 72 hours.~Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to 72 hours|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||pg*h/mL|Participants|Full Range|Mean
48036|NCT01345786|Primary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~AUClast is the AUC from time 0 to the time of the final quantifiable sample.~AUC infinity is the AUC from time 0 to infinity.~Blood samples for PK evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of the last measurable sample (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||ng*h/mL|Participants|Full Range|Mean
48037|NCT01345786|Primary|Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to time of maximum observed serum concentration of E2 (tmax of E2) (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||pg/mL|Participants|Full Range|Mean
48038|NCT01345786|Primary|Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~Blood samples for pharmacokinetic (PK) evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of maximum observed plasma concentration of NOMAC (tmax of NOMAC) (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."||ng/mL|Participants|Full Range|Mean
48039|NCT01345721|Secondary|Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination|The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.|Day 1-28 after vaccination|The analysis was done on the safety dataset.||Participants|||Number
48040|NCT01345721|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination|The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.|Day 1-7 after vaccination|The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data||Participants|||Number
48041|NCT01345721|Secondary|Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset||Titers||95% Confidence Interval|Geometric Mean
48042|NCT01345721|Secondary|Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset||Percentages||95% Confidence Interval|Number
48043|NCT01345721|Primary|Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine|The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
48044|NCT01345721|Primary|Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination|The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y|1 month after vaccination|The analysis was done on the per-protocol dataset.||Percentages||95% Confidence Interval|Number
48046|NCT01345721|Primary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination|The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.|1 month post booster|The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.||Percentages||95% Confidence Interval|Number
48047|NCT01345721|Secondary|Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|13-33 months after primary vaccination|The analysis was done on the per-protocol persistence dataset.||Titers||95% Confidence Interval|Geometric Mean
48048|NCT01345721|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|"The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported.~The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)"|13-33 months post primary vaccination|The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.||Percentages||95% Confidence Interval|Number
48049|NCT01345682|Secondary|Time to Deterioration in Global Health Status|The time to deterioration was defined as the time from randomisation to a score decreased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS||months||95% Confidence Interval|Median
48050|NCT01345682|Secondary|Time to Deterioration in Swallowing|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS||months||95% Confidence Interval|Median
48051|NCT01345682|Secondary|Time to Deterioration in Pain|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS||months||95% Confidence Interval|Median
48052|NCT01345682|Secondary|Status Change in Global Health Status Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48053|NCT01345682|Secondary|Status Change in Swallowing Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48054|NCT01345682|Secondary|Status Change in Pain Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48055|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||scores on a scale||Standard Error|Mean
48085|NCT01345630|Secondary|Number of Participants With Grade 3 or 4 AEs|Number of participants with grade 3 or 4 AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
48056|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||scores on a scale||Standard Error|Mean
48057|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)||scores on a scale||Standard Error|Mean
48058|NCT01345682|Secondary|Tumour Shrinkage|"Tumour shrinkage, defined as the maximum decrease from baseline in the sum of diameters of the target lesions, as measured by central imaging. The longest diameter of target lesions was recorded, except for lymph nodes, which were measured by their short axis.~Negative values indicate a reduction in the sum of target lesion diameters and positive values an increase.~Percentage of Participants with Tumour shrinkage as per the categories (>=20% increase, >=0 − <20% increase, >0 − <30% decrease, >=30 − <50% decrease, >=50% decrease) are presented."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months)|RS (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48059|NCT01345682|Secondary|Disease Control (DC)|"DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD.~CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis).~PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;~SD for TL: change in the sum of diameters does not satisfy PR or PD.~SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months)|RS||percentage of participants||95% Confidence Interval|Number
48060|NCT01345682|Secondary|Objective Response (OR)|"OR is defined as the best overall response of complete response (CR) and partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis).~PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;~All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months)|RS||percentage of participants||95% Confidence Interval|Number
48061|NCT01345682|Secondary|Overall Survival (OS)|Overall survival (OS) was a key secondary endpoint of this trial. OS was defined as the time from randomisation to death (irrespective of the cause of death). Patients for whom there was no evidence of death at the cut-off date (30 Jun 2014) were to be censored on the date that they were last known to be alive.|From randomization until death or data cut-off (30Jun2014); Up to 29 months|RS||months||95% Confidence Interval|Median
48062|NCT01345682|Primary|Progression-free Survival (PFS) Based on Central Independent Review|"PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the cut-off date (7 May 2014).~The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied:~At least 20% increase in the SoD of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm~Appearance of one or more new lesions~Unequivocal progression of existing non-target lesions"|From randomization until disease progression, death or data cut-off (07May2014); Up to 28 months|RS||months||95% Confidence Interval|Median
48063|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)|Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||pg/mL||Standard Deviation|Mean
52438|NCT01292265|Primary|Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
48064|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin|Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||ng/mL||Standard Deviation|Mean
48065|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||g/cm^2||Standard Error|Least Squares Mean
48066|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||g/cm^2||Standard Error|Least Squares Mean
48067|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||g/cm^2||Standard Error|Least Squares Mean
48068|NCT01345630|Secondary|Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
48069|NCT01345630|Secondary|Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.||gram||Standard Error|Least Squares Mean
48070|NCT01345630|Secondary|Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48|The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||Ratio||Standard Deviation|Mean
48071|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)|The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||Percentage of lymphocytes||Standard Deviation|Mean
48072|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)|The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||cell/mm^3||Standard Deviation|Mean
48073|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)|The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||Percentage of lymphocytes||Standard Deviation|Mean
48074|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)|The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.||cell/mm^3||Standard Deviation|Mean
48075|NCT01345630|Secondary|Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria|For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI’s were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. The assessment was performed using the overall (ie. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15 for the MVC+DRV/r arm and 3 for the FTC/TDF+DRV/r arm.||participants|||Number
48076|NCT01345630|Secondary|Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.|For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.||participants|||Number
48077|NCT01345630|Secondary|Tropism Change Between Screening or Baseline and PDTF|For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF.|Week 48|Number of Evaluable PDTF = Virology Analysis Population (VAP) 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).||participants|||Number
48078|NCT01345630|Secondary|Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).|Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012).|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. No imputation for missing values was performed for this endpoint. 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).||Number of participants|||Number
48079|NCT01345630|Secondary|The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).|The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA’s Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.||proportion of participants|||Number
48080|NCT01345630|Secondary|Severity of Abnormal Laboratory Values|Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
48081|NCT01345630|Secondary|Number of Participants With Abnormal Laboratory Values|Number of participants with laboratory abnormalities are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. One participant was not analyzed for laboratory data as the collection date for all lab data was less than the first active therapy date.||participants|||Number
48082|NCT01345630|Secondary|Number of Participants With Treatment-emergent Serious Adverse Events|Total number of participants with treatment-emergent serious adverse events are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
48083|NCT01345630|Secondary|Number of Treatment-related AEs|Number of treatment-related AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||events|||Number
48084|NCT01345630|Secondary|Number of Participants Who Discontinued Due to AEs|Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
48086|NCT01345630|Secondary|Frequency of Adverse Events (AE).|Number of participants with treatment-emergent non serious AEs|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.||participants|||Number
48087|NCT01345630|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.|The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.|Week 48|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of the study drug. The missing value was imputed per FDA’s MSDF Snapshot algorithm as described under “Outcome Measure Description” above.||Percentage of participants|||Number
48088|NCT01345292|Secondary|Global Subjective VAS Score at Week 4|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
48089|NCT01345292|Secondary|Global Subjective VAS Score at Week 2|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
48090|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
48091|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
48092|NCT01345292|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
48093|NCT01345292|Secondary|Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
48159|NCT01344538|Primary|Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo.|% Change between baseline and day 28 in PGE2 levels standardized by protein|Baseline and day 28|||percentage of change from baseline||Standard Deviation|Mean
48094|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
48095|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams of force||Standard Error|Least Squares Mean
48096|NCT01345253|Secondary|Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks.|Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|52 weeks|MITT Population||Days||Inter-Quartile Range|Median
48097|NCT01345253|Secondary|Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks.|Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compaired between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.|Week 52|MITT Population||Days||Inter-Quartile Range|Median
48098|NCT01345253|Secondary|Percent of Participants With SRI7 Response at Week 52.|SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time point were analyzed.||Percentage of participants|||Number
48099|NCT01345253|Secondary|Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.|The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time points were analyzed.||Percentage of participants|||Number
48100|NCT01345253|Primary|Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52.|SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Week 52|Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.||Percentage of participants|||Number
48101|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|Up to Study End at Month 51||12/2017||||
48102|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48103|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48104|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48105|NCT01345240|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48106|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|Up to Study End at Month 51||12/2017||||
48107|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From study start at Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48108|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 to Month 8.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48109|NCT01345240|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48110|NCT01345240|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subject|||Number
48140|NCT01345123|Primary|Total Medical Costs Per Member Per Month|total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Instituted >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.||Total dollars / member months||95% Confidence Interval|Mean
48111|NCT01345240|Secondary|Anti-Rotavirus (Anti-RV) Antibody Concentrations|Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix™ as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Rotarix™. Results presented are for the study groups pooled by RTS,S or Engerix-B™ vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.|At Month 3, aka one month post Dose 2 of Rotarix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||U/mL||95% Confidence Interval|Geometric Mean
48112|NCT01345240|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT)|The antibodies against BPTassessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL.|At Day 0 and at Month 3 (one month post Dose 3 of Infanrix™-Hib)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
48113|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. . Results will be posted when they become available.|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
48114|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
48115|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.|The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. Results will be posted when they become available.|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Titer||95% Confidence Interval|Geometric Mean
48116|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.|"The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8.~This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups."|At Month 3, aka at one month (1M) post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Titer||95% Confidence Interval|Geometric Mean
48117|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.|Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA). Results will be posted when they become available.|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||μg/mL||95% Confidence Interval|Geometric Mean
48157|NCT01344616|Primary|Birthweight|Birth weight < 2500 grams|9 months|One Set of twins in the lifestyle counseling arm and 4 sets of twins in the usual clinical care arm||participants|||Number
48118|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.|Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA). This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
48119|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations .|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. Results for months 38 and 50 will be posted when they become available.|At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B™.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
48120|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results with study groups pooled by vaccination regimen received.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
48121|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. Results will be posted when they become available.|At Month 51, aka one month post the Month 50 booster dose of Engerix-B™||12/2017||||
48122|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
48123|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. Results will be posted when they become available.|At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B™ and one month post the Month 50 booster dose of Engerix-B™||12/2017||||
48124|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. Results for Months 38 and 50 will be posted when they become available.|At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
48125|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
48158|NCT01343485|Primary|On-time Completion of the Human Papillomavirus Vaccine Series||32 weeks after receipt of initial vaccine|||participants|||Number
48207|NCT01344369|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
48126|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by RTS,S or Engerix-B™ vaccination regimen received.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
48127|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B™).|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
48128|NCT01345162|Secondary|Development of Persistent Postoperative Pain|Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain.|Up to 3 months||||||
48129|NCT01345162|Secondary|Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications|"Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain.~Assessment of any difference between the two groups."|4 days postherniotomy||||||
48130|NCT01345162|Secondary|Difference in Recovering Daily Activity|Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)|4 days after surgical procedure||||||
48131|NCT01345162|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded.~Assessment of any difference between the two groups."|4 days postherniotoy||||||
48132|NCT01345162|Primary|Analgesic Efficacy|"percentage of patients with NRS≥4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible).~NRS≥4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs."|4 days postherniotomy|||percentage of patients with NRS≥4|||Number
48133|NCT01345123|Primary|Total Medical Costs That Can be Impacted Per Member Per Month|"total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.~Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded"|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.||Total dollars / member months||95% Confidence Interval|Mean
48134|NCT01345123|Secondary|Decision Satisfaction|Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again.|6 months||||||
48135|NCT01345123|Secondary|Decision Conflict|Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents.||units on a scale||95% Confidence Interval|Mean
48136|NCT01345123|Secondary|Knowledge|Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score.||number of correct answers||95% Confidence Interval|Mean
48137|NCT01345123|Secondary|Quality of Decision Making Process|Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions.|6 months||||||
48138|NCT01345123|Secondary|Concordance|Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function|6 months||||||
48139|NCT01345123|Secondary|Rate of Targeted Conditions Surgeries|rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.||percentage of participants|||Number
48141|NCT01344876|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs.||participants|||Number
48142|NCT01344876|Secondary|Treatment Response|"Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin’s lymphoma, acute myeloid leukemia, chronic myeloid leukemia.~“Response” was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment."|From first dose of study medication to withdrawal examination|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.~No statistical analysis provided for treatment response."||participants|||Number
48143|NCT01344876|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.||participants|||Number
48144|NCT01344759|Secondary|Room Air SpO2|The patient's oxygen saturation on room air.|During MRI and until recovery room discharge - approximately 30-250 minutes|||percentage of SpO2||Inter-Quartile Range|Mean
48145|NCT01344759|Secondary|Needed Artificial Airway|This is the count of the number of patients who needed an artificial airway.|During MRI and until recovery room discharge - approximately 30-250 minutes|||Number of artifical airway events|||Number
48146|NCT01344759|Secondary|Respiratory Disturbance Index|The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.|During MRI and until recovery room discharge - approximately 30-250 minutes|||respir.disturbance events/hr of sleep||Inter-Quartile Range|Mean
48147|NCT01344759|Secondary|Obstructive Index Until Recovery Room Discharge|The Obstructive Index is a count of the obstructive apnea events per hour of sleep|During MRI and until recovery room discharge - approximately 30-250 minutes|||Apnea events/hour of sleep||Inter-Quartile Range|Mean
48148|NCT01344759|Primary|Cross Sectional Area of the Pharyngeal Airway|The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.|during MRI within first 10 minutes of scanning|||mm^2||95% Confidence Interval|Median
48149|NCT01344629|Secondary|MRTpo|mean residence time of Telmisartan in the body after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||hour||Geometric Coefficient of Variation|Geometric Mean
48150|NCT01344629|Secondary|t1/2|terminal half-life of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||hour||Geometric Coefficient of Variation|Geometric Mean
48151|NCT01344629|Secondary|λz|terminal rate constant of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||/hour||Geometric Coefficient of Variation|Geometric Mean
48152|NCT01344629|Secondary|Tmax|time from dosing to the maximum concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.||hour||Full Range|Mean
48153|NCT01344629|Secondary|AUC0-∞|area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
48154|NCT01344629|Primary|Cmax|maximum measured concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48155|NCT01344629|Primary|AUC0-tz|Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
48156|NCT01344616|Secondary|Gestational Weight||9 months||||||
48160|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
48161|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
48162|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
48163|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.||participants|||Number
48164|NCT01344460|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they had recommended an additional imaging study for each participant, and the data were recorded.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
48165|NCT01344460|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1=Not confident; 2=Somewhat confident; 3=Confident; 4=Very confident.|Images were taken pre-injection and post-injection|"FAS; In the below table, n signifies the number of segments that were evaluable in specified category."||Units on scale||Standard Deviation|Mean
48166|NCT01344460|Secondary|The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
48167|NCT01344460|Secondary|The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
48168|NCT01344460|Secondary|The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present.|Images were taken pre-injection and post-injection|FAS||percentage of accessory|||Number
48169|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|||Number
48170|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|||Number
48171|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifact presence.||percentage of segments|||Number
48172|NCT01344460|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||percentage of segments|||Number
48173|NCT01344460|Secondary|The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis >=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta.|Images were taken pre-injection and post-injection|"Participants in FAS that were evaluable; in below table, n signifies the number of segments that were evaluable in specified category."||Percentage of location|||Number
48174|NCT01344460|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR).|Images were taken pre-injection and post-injection|Evaluable participants in FAS||mm|Participants|Standard Deviation|Mean
48175|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||millimeter(s) (mm)||Standard Deviation|Mean
48176|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||millimeter(s) (mm)||Standard Deviation|Mean
48177|NCT01344460|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease (stenosis) was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of specificity|Participants||Number
48178|NCT01344460|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%|Clinically significant disease was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of sensitivity|Participants||Number
48179|NCT01344460|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of specificity|Participants||Number
48180|NCT01344460|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of sensitivity|Participants||Number
48181|NCT01344460|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category for both groups."||Percentage of segments|Participants||Number
48182|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
48183|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
48184|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
48185|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.||participants|||Number
48186|NCT01344447|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.|Images were taken pre-injection and post-injection|FAS||percentage of participants|||Number
48187|NCT01344447|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1 = Not confident, 2 = Somewhat confident, 3 = Confident, and 4 = Very confident.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments that were evaluable for the specified category of each group."||units on a scale||Standard Deviation|Mean
48188|NCT01344447|Secondary|Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present. If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments with presence of secondary radiologic indicators for the specified category of each group."||percentage of segments|||Number
48189|NCT01344447|Secondary|The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies segments that were evaluable for the specified category of each group."||percentage of radiologic indicator|||Number
48190|NCT01344447|Secondary|Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%. If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated. If there was no stenosis of >=70% in a segment then the length was designated as 0.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in the below table, n signifies number of segments that were evaluable for the specified category of each group."||millimeter(s)||Standard Deviation|Mean
48191|NCT01344447|Secondary|The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; in the below table, n signifies number of locations that were evaluable for the specified category of each group."||pecentage of location|||Number
48192|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|Participants||Number
48193|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|Participants||Number
48208|NCT01344161|Primary|Change in Insulin Concentrations||3 months minus baseline|||pmol/L||Standard Deviation|Mean
48209|NCT01344161|Primary|Change in Post Load Glucose Concentrations|It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).|3 months minus baseline|||mmol/L||Standard Deviation|Mean
48194|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.||percentage of segments|Participants||Number
48195|NCT01344447|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS||percentage of segments|Participants||Number
48196|NCT01344447|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).|Images were taken pre-injection and post-injection|FAS; Number of participants/segments analyzed in below ordered categories (Normal-BRs; Narrowest-BRs; Normal-CIs; Narrowest-CIs) in Enhanced MRA group was 457/6182, 457/6182, 419/1361, 419/1352 respectively; in Unenhanced MRA group was 455/4776, 455/4776, 367/989, 367/980 respectively; in CTA was 442/3158, 442/3158, 419/1569, 419/1555 respectively.||millimeter(s) (mm)||Standard Deviation|Mean
48197|NCT01344447|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of specificity|Participants||Number
48198|NCT01344447|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."||percentage of sensitivity|Participants||Number
48199|NCT01344447|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group if it varies from Number of participants/segments analyzed."||percentage of specificity|Participants||Number
48200|NCT01344447|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group."||percentage of sensitivity|Participants||Number
48201|NCT01344447|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.|Images were taken pre-injection and post-injection|FAS||percentage of segments|Participants||Number
48202|NCT01344369|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
48203|NCT01344369|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
48204|NCT01344369|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
48205|NCT01344369|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
48206|NCT01344369|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
48210|NCT01344161|Primary|Change in Glucose Concentrations||3 months minus baseline|||mmol/L||Standard Deviation|Mean
48211|NCT01344161|Primary|Change in Body Fat Mass|Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.|3 months minus baseline|We assessed body composition by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).||kg||Standard Deviation|Mean
48212|NCT01344057|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using PP set.||Percentage of participants||95% Confidence Interval|Number
48213|NCT01344057|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using PP set.||Ratio||95% Confidence Interval|Geometric Mean
48214|NCT01344057|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 1 up to and including day 4 after the FLUAD vaccination.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; participants who received study vaccination and who provided post-vaccination safety data.||Number of participants|||Number
48215|NCT01344057|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had correctly received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
48216|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48217|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48218|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48219|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48220|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48221|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48222|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48223|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
48224|NCT01343888|Secondary|Early Treatment Success (ETS)|Early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants|||Number
48225|NCT01343888|Secondary|Sustained Virological Response 24 Weeks Post-treatment (SVR24)|Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
48226|NCT01343888|Primary|Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
48227|NCT01343823|Secondary|Time to Symptom Resolution Based on the Visual Analog Scale (VAS)|"Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups.~The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from totally resolved to very severe."|6 hours|Time to Symptom Resolution Based on the VAS (Safety Population)||hours||95% Confidence Interval|Median
48228|NCT01343823|Primary|Safety and Efficacy of Ecallantide|"Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy.~Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER.~A responder was defined as a patient meeting all six discharge eligibility criteria as below:~Improvement of edema to “a little better” or “a lot better” as assessed by health care provider using a five point scale~Stable vital signs (within an acceptable range)~Absence of stridor~Absence of dyspnea or use of accessory muscles during respiration~Absence of drooling~Able to drink without difficulty"|6 hours|Safety Population||participants||95% Confidence Interval|Number
48229|NCT01343667|Primary|Major Adverse Events (MAE)|Major Adverse Events include death, stroke and myocardial infarction|Onset from start of index procedure to 30-day follow-up assessment|Enrolled subjects with successful procedure and sufficient follow-up||participants|||Number
48230|NCT01343277|Primary|Overall Survival (OS)|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]|Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).||Months||95% Confidence Interval|Median
48231|NCT01343277|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])|Safety population included all the treated participants.||Participants|||Number
48232|NCT01343277|Secondary|Duration of Response|"Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.~Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Months||95% Confidence Interval|Median
48233|NCT01343277|Secondary|Objective Response Rate|The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Percentage of Participants||95% Confidence Interval|Number
48234|NCT01343277|Secondary|Time to Progression|"Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.~Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Months||95% Confidence Interval|Median
48235|NCT01343277|Secondary|Progression-Free Survival (PFS)|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."||Months||95% Confidence Interval|Median
48236|NCT01343251|Secondary|Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)|Compare incidence of hospitalization (for any reason) between study arms. Reasons for hospitalizations included: infection, cardiac problems, bleeding, vascular access thrombosis, fall (injury), hematuria, fluid overload, peripheral neuropathy, pulmonary embolism, edema, and shortness of breath.|1 year|||Percentage of patients|||Number
48237|NCT01343251|Secondary|Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)|Compare vascular intervention rates between study arms. The vascular interventions which were included were: Angioplasty, Thrombectomy, Arteriovenous (AV) Fistulogram/Diagnostic Angiogram, Banding, Access Removal, Access Exchange, Access Revision, Creation of New Access, and any combination of these interventions which were performed simultaneously.|1 year|||percentage of participants|||Number
48238|NCT01343251|Secondary|Quality of Life|Compare the RAND Short Form (SF)-36 Health Survey, Total Test Scores at baseline, 3, 6, and 12 months between study arms. Total test scores range on a scale from 0-100, with the lower the score equating to more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The total score is calculated using a methodology described by the RAND Corporation, which assigns a recoded value to each survey item. Recoded items are averaged amongst scales and the total score is an average of the eight sections. (http://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_core_36item_scoring.pdf).|1 year|The number of completed tests varied by time point and study group. The number of completed tests for Test 1, Test 2, Test 3, and Test 4 was 14, 13, 10, and 8 for the HeRO Graft group and 17, 13, 7, and 4 for the Control group, respectively. Only completed tests were included in the analysis.||units on a scale||Standard Deviation|Mean
48239|NCT01343251|Secondary|Infection Rate (Percentage of Participants With at Least One Infection)|Compare incidence of infection between study arms|1 year|||Percentage of Patients|||Number
48240|NCT01343251|Primary|Mortality|Compare mortality rate between study arms|1 year|||percentage of participants who died|||Number
48241|NCT01343082|Primary|Change From Baseline in IOP (Intraocular Pressure) at End of Study||Treatment period: Week 0 (Baseline) and Week 52 (End of Study)|||mmHg||Standard Deviation|Mean
48242|NCT01342965|Secondary|Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire||approximately 21 months||||||
48243|NCT01342965|Secondary|Safety: Incidence of Adverse Events||36 months||||||
48244|NCT01342965|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|Baseline to the end of the study (3 years, 1 month)|Full analysis set: All randomized participants.||Months||95% Confidence Interval|Median
48245|NCT01342965|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants. Only participants who had a complete response or partial response were included in the analysis.||Months||95% Confidence Interval|Median
48246|NCT01342965|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.||Percentage of participants|||Number
48247|NCT01342965|Secondary|Percentage of Responders as Assessed by the Investigator|A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.||Percentage of responders|||Number
48295|NCT01342458|Secondary|First Peak of the Knee Adduction Moment (KAM) During Gait.|The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure.|6 month|||% body weight x height in centimeters||Standard Deviation|Mean
48248|NCT01342965|Primary|Investigator-assessed Duration of Progression-free Survival|The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.|Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)|Full analysis set: All randomized participants.||Months||95% Confidence Interval|Median
48249|NCT01342913|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.|Baseline and Day 85|Only participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
48250|NCT01342913|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.||Minutes||Full Range|Median
48251|NCT01342913|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
48252|NCT01342770|Secondary|Post-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Time of surgery|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained||SUV||Full Range|Median
48253|NCT01342770|Secondary|Pre-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Baseline|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained||SUV||Full Range|Median
48254|NCT01342770|Secondary|Percent Change in SUVmax From the PET Scan|The percent change from pre to post-intervention in SUV max values will be summarized using descriptive statistics and simple graphical plots.|Baseline to the time of surgery|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained||Percent change in tumor SUV max values||Full Range|Median
48255|NCT01342770|Secondary|Percent Change in PPARy|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in PPARy measurements||Full Range|Median
48256|NCT01342770|Secondary|Percent Change in p21|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in p21 measurements||Full Range|Median
48257|NCT01342770|Secondary|Percent Change in MUC1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in MUC1 measurements||Full Range|Median
48258|NCT01342770|Secondary|Percent Change in Cyclin D1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically as well as formally assessed using Wilcoxon signed rank tests.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in Cyclin D1 measurements||Full Range|Median
48259|NCT01342770|Secondary|Number of Participants With Complete Pathologic Response|Complete pathologic response was defined as no viable residual tumor cells. Acellular residual mucin pools also considered a pathologic complete response.|Up to the time of surgery|Includes all registered participants||participants|||Number
48260|NCT01342770|Secondary|Number of Participants With Clinical Response, Based on Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1|Clinical response rates will be summarized. Complete response (CR) is the disappearance of all non-nodal target lesions (TL) and each target lymph node (LN) must have reduction in short axis to <1.0cm. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the non-nodal TR and the short axis of the target LN with the baseline sum diameters (BSD) as reference. Progression (PD) is at least 1 new malignant lesion or LN whose short axis increased to >1.5 cm or at least a 20% increase in the sum of TL diameters with the minimum sum of diameters as reference.|Up to the time of surgery||||||
48296|NCT01342458|Secondary|Six-minute Walk Test|The six-minute walk test assesses distance in meters walked over 6 minutes.|6 month|||meter||Standard Deviation|Mean
48261|NCT01342770|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.0|To evaluate the adverse events profile, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (both regardless of attribution as well as those that are at least possibly, probably, or definitely related) will be tabulated and summarized.|Up to the time of surgery|Includes all registered eligible participants||participants|||Number
48262|NCT01342770|Secondary|Gene Expression Analysis of RNA From Bronchial Brush Cells|For the gene expression profiles obtained from the data from normal bronchial brush cells, each participant’s pre- and post gene expression will be graphically represented and the mean expression levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Up to the time of surgery||||||
48263|NCT01342770|Secondary|Change in Levels of Serum CRP|Each participant’s pre- and post serum levels of CRP will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline to the time of surgery||||||
48264|NCT01342770|Secondary|Change in Levels of Serum CA-153|Each participant’s pre- and post serum levels of CA-153 will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline to the time of surgery||||||
48265|NCT01342770|Secondary|Change in Apoptosis Assessment (e.g., Caspase-3)|Changes in the expression levels (or grades) from baseline (prior to intervention) to post-intervention (resected tumor sample) will be plotted graphically as well as formally assessed using the McNemar’s tests (for categorical variables) or Wilcoxon signed rank tests (for continuous variables) respectively.|Baseline to the time of surgery||||||
48266|NCT01342770|Primary|Percent Change in Ki-67 by Immunohistochemistry (IHC)|Changes in the expression levels of Ki-67 will be plotted graphically, and percent change in expression levels will be formally assessed using the paired t-test or the Wilcoxon signed rank test, if the assumptions of the t-test (i.e. normality) are not met.|Baseline to the time of surgery|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration||Percent change in Ki-67 measurements||Full Range|Median
48267|NCT01342757|Primary|Measurable Change on Magnetic Resonance Spectroscopy Imaging After Vorinostat Administration|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and NAA signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks|Patients collected until measurable spectroscopic indexes were available in at least three cases with metabolic response and three without metabolic response||Spectroscopic index||Standard Deviation|Mean
48268|NCT01342757|Secondary|Mean (or Median) Change in Metabolite Levels||Baseline to 1 week||||||
48269|NCT01342757|Primary|Proportion of Patients Who Experience Metabolic Restoration Between the Responders and Non-responder Groups by MRS Scans||After 1 week||||||
48270|NCT01342757|Primary|Proportion of Patients With Magnetic Resonance Spectroscopy Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and N-acetylaspartate signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks|||participants|||Number
48271|NCT01342666|Primary|High Density Lipoprotein Cholesterol (HDL-c)|To evaluate the effect of two daily tomatoes consumption on HDL-c levels.|Baseline and after one month|The sample size was calculated using the formula for means for two-tailed comparisons. According to a previous report, we expected a minimal change of 5 mg/dL in HDL-c after one month of consumption. Using a SD of 9 mg/dL with alfa of 0.05 and study power of 80%, a total of 48 subjects were calculated.||mg/dL||Standard Deviation|Mean
48272|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 28|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 28|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome||gm/dL||Standard Deviation|Mean
48273|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 24|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 24|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.||gm/dL||Standard Deviation|Mean
48288|NCT01342484|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.||Percentage of HbA1c||Standard Error|Least Squares Mean
48274|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 20|Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 20|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point.||Grams per deciliter (gm/dL)||Standard Deviation|Mean
48275|NCT01342549|Primary|Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.||24 weeks|||Weeks||Standard Deviation|Mean
48276|NCT01342523|Secondary|Increased Quit Attempts|Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.|Measured at the 1 month, 3 month and 7 month follow up assessments.||||||
48277|NCT01342523|Secondary|Treatment Satisfaction|We will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.|Measured at the 1 month, 3 month and 7 month follow up assessments||||||
48278|NCT01342523|Secondary|Perceived Support|We will measure perceived support from both treatment and non-treatment resources.|Measured at the1 month, 3 month and 7 month follow up assessments.||||||
48279|NCT01342523|Secondary|Withdrawal Symptoms|We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.||||||
48280|NCT01342523|Secondary|Effectiveness of the Experimental Resources.|We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.|Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.||||||
48281|NCT01342523|Secondary|Resource Use/Engagement|We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.|Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.||||||
48282|NCT01342523|Secondary|Smoking Outcomes|Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.||||||
48283|NCT01342523|Primary|7-Day Point-Prevalence Abstinence From Smoking|Abstinence will be defined as 7-day point prevalence.|Measured after the 3 month follow up assessment|"Intention to treat (ITT)"||percentage of participants not smoking|||Number
48284|NCT01342510|Primary|Number of Patients With Pain Associated With Injection of Propofol.|Ten seconds following injection of propofol, subjects were asked “Are you having pain at your IV site?” Any behavioral signs were noted. Injection pain was assessed using the following four point scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).|< 1 minute.|||participants|||Number
48285|NCT01342510|Primary|Pain With Injection of Propofol|Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).|Approximately one minute following administration of propofol.||||||
48286|NCT01342484|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment|Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.||mmol/L||Standard Error|Least Squares Mean
48287|NCT01342484|Secondary|Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State|DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100.|Baseline and 4 weeks or 8 weeks or 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. OR (Original Results). The analysis excludes placebo patients and 1 FAS patient from Linagliptin 1 mg group.||Percentage of DPP-4 inhibition||Inter-Quartile Range|Median
48289|NCT01342471|Secondary|TV Viewing Time|Change in self-reported TV viewing time per day between 0 and 6 months|0 and 6 months|||hr/day||Standard Deviation|Mean
48290|NCT01342471|Secondary|Weight|Change in weight in kgs between 0 and 6 months|0 and 6 months|||kg||Standard Deviation|Mean
48291|NCT01342471|Secondary|TV Related Energy Intake|Change in energy intake (kcals/day) while watching TV between 0 and 6 months|0 and 6 months|||kcals/day||Standard Deviation|Mean
48292|NCT01342471|Secondary|Total Energy Intake|Change in total energy intake(kcals/day) between 0 and 6 months|0 and 6 months|||kcals/day||Standard Deviation|Mean
48297|NCT01342458|Secondary|Global Score of the Lequesne´s Questionaire Algo-functional.|This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively.|6 month|||score||Standard Deviation|Mean
48298|NCT01342458|Secondary|WOMAC Total Score|The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition.|6 month|||score||Standard Deviation|Mean
48299|NCT01342458|Secondary|WOMAC Physical Function Subscale|The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.|6 month|||score||Standard Deviation|Mean
48300|NCT01342458|Secondary|WOMAC Stiffness Subscale|The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.|6 month|||score||Standard Deviation|Mean
48301|NCT01342458|Primary|Western Ontario and McMaster Universities (WOMAC) Pain Subscale|The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.|6 month|An intention-to-treat analysis was performed, and the missing data were treated as missing completely at random (MCAR) using the Mahalanobis imputation method (SOLAS software version 4.0; Statistical Solutions Ltd., Cork, Ireland).||score||Standard Deviation|Mean
48302|NCT01342445|Primary|Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)|BRIEF-A is a standardized self-report measure that captures adults’ views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.|after receiving Placebo or LDX for 1 week|||T score||Standard Deviation|Mean
48303|NCT01342445|Primary|Conners Adult ADHD Rating Scale - Short Version (CAARS)|CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).|after receiving Placebo or LDX for 1 week|||T score||Standard Deviation|Mean
48304|NCT01342341|Primary|Alcohol Consumption in Drinks/Week.|Each subject will record how many drinks/week they are consuming while on the study drug and placebo during the 45-day study. The primary outcome of this study is to determine the effect of chlorzoxazone on alcohol consumption. Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide.|45 days|||number of drinks||Standard Deviation|Mean
48305|NCT01342172|Secondary|To Determine the Impact of Treatment on Circulating Tumor Cells|Circulating epithelial tumor cells (CTC) will be investigated as an experimental endpoint using immunofluorescence techniques and CTC identification by positive expression of epithelial markers and a viability marker and negative expression of hematopoietic markers. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycles 0, 1 and 2 (each Cycle is 21 days)||||||
48306|NCT01342172|Secondary|To Determine the Impact of Treatment on Peripheral Blood Immune Cell Subsets|We plan to determine the changes in cellular immunity with lenalidomide in peripheral blood mononuclear cells including Tregs, NK, NKT cells (Berg et al JCO 2010), sIl-2R, TNF alpha (Bartlett et al BJC 2004) and markers indicative of activation, i.e. CD107a. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycle 0 and Day 1 of Cycle 2 (each Cycle is 21 days)||||||
48307|NCT01342172|Secondary|To Evaluate Lenalidomide as Maintenance Treatment in Patients Achieving an Objective Response or Stable Disease Following Completion of 6 Cycles of Combination Therapy.||168 days||||||
48308|NCT01342172|Secondary|To Determine the Safety of Combination Therapy With Gemcitabine, Cisplatin, and Lenalidomide|The safety of combination therapy with gemcitabine, cisplatin plus lenalidomide as determined by the frequency and severity of adverse events as per the NCI Common Terminology for Adverse Events (CTCAE) version 4.0.|Day 1 and Day 8 of each treatment cycle; 21 days after the last dose of Lenalidomide||||||
48309|NCT01342172|Secondary|To Determine the Objective Response Rate to Treatment With Gemcitabine, Cisplatin, Plus Lenalidomide|The objective response rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST). Restaging CT scans will be performed after every 2 cycles (after cycles 2, 4, and 6). Each cycle is 21 days.|After every 2 cycles (a cycle is 21 days)||||||
48310|NCT01342172|Primary|Phase II: Progression-free Survival at 1 Year||1 year||||||
48311|NCT01342172|Primary|Phase I: To Determine the Recommended Phase II Dose of the Combination of Gemcitabine, Cisplatin, Plus Lenalidomide|Safety as measured by the frequency and type of adverse event as per the NCI Common Terminology for Adverse Events (CTCAE) version 4 on Day 1 of each cycle (Cycle is 21 days).|Day 1 of each 21 day cycle|The dose of lenalidomide was not escalated beyond 10 mg because of cytopenias requiring repeated dose delays and reductions.|||||
48338|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48312|NCT01342107|Primary|Lens Wettability|As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.|16 hours|Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set.||percentage of lenses||95% Confidence Interval|Number
48313|NCT01342094|Primary|Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study|Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)|||mmHg||Standard Deviation|Mean
48314|NCT01342081|Primary|Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study|Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)|||mmHg||Standard Deviation|Mean
48315|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 8, 16 hours|Intent to treat.||Degrees||Standard Deviation|Mean
48316|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 1, 8 hours|Intent to Treat.||Degrees||Standard Deviation|Mean
48317|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)|Day 90|||Subjective Rating||Standard Deviation|Mean
48318|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert item|Day 90||||||
48319|NCT01341912|Secondary|To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis|"The efficacy of human-cl rhFVIII will be determined using a 4 point efficacy assessment scale.~After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 - 12 hours after an infusion requiring up to 2 infusions for complete resolution.~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.~The assessment was made at the end of a BE in case more than one infusion was needed."|up to 3 years|||percentage of bleeding episodes|Participants||Number
48320|NCT01341912|Primary|Long-term Immunogenicity|Patients will be monitored for inhibitors against FVIII every 3 months. Blood samples were drawn and inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) in the central lab.|up to 3 years|||occurrence of inhibitors|||Number
48321|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL|iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set||visits||Standard Deviation|Mean
48322|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set||visits||Standard Deviation|Mean
48323|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set||percentage of participants||95% Confidence Interval|Number
48324|NCT01341782|Secondary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|The last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set||percentage of participants||95% Confidence Interval|Number
48325|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia|The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).|The Full Analysis Set (FAS) consists of all randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline iPTH measurement.||percentage of participants||95% Confidence Interval|Number
48339|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48326|NCT01341782|Primary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).|The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken.||percentage of participants||95% Confidence Interval|Number
48327|NCT01341067|Secondary|Change in Basal Insulin Dose From Baseline Values||Assessed at baseline and 6 months|||units of insulin||Standard Deviation|Mean
48328|NCT01341067|Secondary|Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl||Measured at baseline and 6 months|||percentage of time spent >180 mg/dl||Standard Deviation|Mean
48329|NCT01341067|Secondary|Percentage of Time Spent at Glycemic Levels <65 mg/dl||Measured at baseline and at 6 months|||percentage of time spent < 65 mg/dl||Standard Deviation|Mean
48330|NCT01341067|Primary|Change in HgbA1c||Measured at 6 months|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
48331|NCT01340937|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population defined as all vaccinated participants with safety follow up and temperature data. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.||Percentage of participants|||Number
48332|NCT01340937|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.||Percentage of participants|||Number
48333|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes|Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||µg/mL||95% Confidence Interval|Geometric Mean
48334|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48335|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48336|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48337|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48340|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48341|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48342|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48343|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48344|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48345|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48346|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48347|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48348|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48349|NCT01340937|Secondary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48350|NCT01340937|Secondary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48385|NCT01340625|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.||pg*h/mL||Standard Deviation|Mean
48351|NCT01340937|Secondary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48352|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Titer||95% Confidence Interval|Geometric Mean
48353|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Titer||95% Confidence Interval|Geometric Mean
48354|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Titer||95% Confidence Interval|Geometric Mean
48355|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48356|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48357|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48358|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48359|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Tetanus Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||IU/mL||95% Confidence Interval|Geometric Mean
48360|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||IU/mL||95% Confidence Interval|Geometric Mean
48361|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||mIU/mL||95% Confidence Interval|Geometric Mean
48362|NCT01340937|Secondary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48363|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||µg/mL||95% Confidence Interval|Geometric Mean
48364|NCT01340794|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years.|Up to 5 years from registration|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable.||months||95% Confidence Interval|Median
48365|NCT01340794|Secondary|Progression-free Survival Time|Progression-free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Progression-free survival time will be estimated using the Kaplan-Meier method.|The time from registration to documentation of disease progression or death, whichever occurs first, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable||months||95% Confidence Interval|Median
48366|NCT01340794|Secondary|Overall Survival Time|Overall survival time is defined as the time from registration to death due to any cause and will be estimated using the Kaplan-Meier method.|The time from registration to death due to any cause, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable||months||95% Confidence Interval|Median
48367|NCT01340794|Secondary|Duration of Tumor Response|Defined for all patients whose tumor met the criteria of CR or PR (using the RECIST criteria) as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. None of the 4 patients that initiated treatment with a run-in responded|||||
48368|NCT01340794|Primary|Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|"Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1) Ninety-five percent confidence intervals for the true response proportion was calculated using the exact binomial test.~Complete Response (CR): All of the following must be true:~Disappearance of all target and non-target lesions.~Each lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR):~At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking baseline measures as reference.~Overall Response (OR) was calculated by summing the number of patients with a CR or PR."|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable||percentage of participants||95% Confidence Interval|Number
48369|NCT01340768|Secondary|Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
48370|NCT01340768|Primary|Percentage of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
48371|NCT01340664|Secondary|Percentage of Patients With HbA1c <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of Participants|||Number
48372|NCT01340664|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
48373|NCT01340664|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
48374|NCT01340664|Primary|Change in HbA1c From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
48375|NCT01340651|Secondary|Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. The area under the plasma concentration-time curve (AUC) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule for increasing concentrations and the log-trapezoidal rule for decreasing concentrations with the software WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA).|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.||nM*h||Standard Deviation|Mean
48376|NCT01340651|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard noncompartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Tmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.||h||Full Range|Median
48377|NCT01340651|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard non-compartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Cmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.||nM||Standard Deviation|Mean
48378|NCT01340651|Secondary|Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
48379|NCT01340651|Secondary|Change From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms. A negative change score indicated improvement.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage change||Standard Deviation|Mean
48380|NCT01340651|Secondary|Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage of participants||95% Confidence Interval|Number
48381|NCT01340651|Secondary|Change From Baseline in Spleen Length at Week 16|Spleen length was measured in centimeters by palpation.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage change||Standard Deviation|Mean
48382|NCT01340651|Secondary|Change From Baseline in Spleen Volume at Week 16|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage change||Standard Deviation|Mean
48383|NCT01340651|Primary|Overall Response (OR) at Week 16|The investigator graded OR according to the International Working Group for Myelofibrosis Research and Therapy criteria for treatment response. As bone marrow biopsies were not taken after baseline, the best achievable response was clinical improvement which required 1 of the following in the absence of progressive disease (PD): (1) A ≥ 2 g/dL increase in hemoglobin level or (2) either a palpable ≥ 50% reduction of splenomegaly of a spleen ≥ 10 cm at baseline or a spleen palpable at > 5 cm at baseline becoming not palpable. PD required 1 of the following: (1) Progressive splenomegaly defined by the appearance of previously absent splenomegaly that was palpable at > 5 cm below the left costal margin or a ≥ 100% increase in palpable distance for baseline splenomegaly of 5-10 cm or a ≥ 50% increase in palpable distance for baseline splenomegaly of > 10 cm or (2) an increase in peripheral blood blast percentage to ≥ 20% that lasted for ≥ 8 weeks. Stable disease: None of the above.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.||Percentage of participants|||Number
48384|NCT01340651|Primary|Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16||Baseline to Week 16|Safety population: All enrolled participants who took at least 1 dose of study drug.||Percentage of participants|||Number
48386|NCT01340625|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.||pg*h/mL||Standard Deviation|Mean
48387|NCT01340625|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.||pg/mL||Standard Deviation|Mean
48388|NCT01340625|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
48389|NCT01340625|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
48390|NCT01340625|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
48391|NCT01340586|Other Pre-specified|Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation|"The number of participants who died or experienced SAEs or AEs leading to discontinuation was reported for each arm.~AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling."|From Day 1 to 30 days post study discontinuation|All treated participants||participants|||Number
48392|NCT01340586|Other Pre-specified|Number of Participants With Laboratory Marked Abnormalities|"ULN=Upper Limit of Normal, LLN=Lower Limit of Normal, Pre-Rx= Baseline value. BUN=Blood Urea Nitrogen (mmol/L=millimoles per Liter): High if BUN > 1.1*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx).~Platelet count (*10^9 cell/L): Low if Platelet Count < 0.85*LLN (if Pre-Rx<LLN: <0.85*Pre-Rx).~Creatine (umol/L=micromoles per Liter): High if Creatine > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Calcium, Total (mmol/L): High if Calcium > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Potassium, serum (mmol/L): High if Potassium > 1.1*ULN (if Pre-Rx>ULN: >1.1*Pre-Rx; if Pre-Rx<LLN: >ULN).~Phosphorus, Inorganic (mmol/L): Low if Phosphate < 0.85*LLN (if Pre-Rx>ULN: <LLN).~Lactate dehydrogenase (U/L=Units per Liter): High if Lactate Dehydrogenase > 1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)."|From 24 hours pre-dose to 72 hours post-dose|All treated participants||participants|||Number
48393|NCT01340586|Secondary|Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban|Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||IU/mL||Standard Deviation|Mean
48394|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban|The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||maximum percent change from baseline||Standard Deviation|Mean
48395|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||maximum percent change from baseline||Standard Deviation|Mean
48396|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||maximum percent change from baseline||Standard Deviation|Mean
48397|NCT01340586|Primary|Percentage of BMS-730823 Extracted During Hemodialysis|The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||percentage of BMS-730823 extracted||Standard Deviation|Mean
48398|NCT01340586|Primary|Percentage of Apixaban Extracted During Hemodialysis|The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||percentage of apixaban extracted||Standard Deviation|Mean
48399|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of BMS-730823|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis||mL/min||Standard Deviation|Mean
48609|NCT01337297|Primary|Abstinence|abstinence to the use of crack-cocaine up to 3 months after the completion of two-weeks of treatment sessions with active-tDCS or sham-tDCS.|Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.|||percentage of participants|||Number
48400|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of Apixaban|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||mL/min||Geometric Coefficient of Variation|Geometric Mean
48401|NCT01340586|Primary|Mean Renal Clearance (CLR) of BMS-730823|Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants||mL/min||Geometric Coefficient of Variation|Geometric Mean
48402|NCT01340586|Primary|Mean Renal Clearance (CLR) of Apixaban|Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants||mL/min||Geometric Coefficient of Variation|Geometric Mean
48403|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)|Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis||percent of dose recovered in dialysate||Standard Deviation|Mean
48404|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Urine (%UR)|The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered.|24 hours pre-dose to 72 hours post-dose|All treated participants||percent of dose recovered in urine||Standard Deviation|Mean
48405|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
48406|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
48407|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823|Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||hours||Full Range|Median
48408|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban|Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||hours||Full Range|Median
48409|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of BMS-730823|Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data.|24 hours pre-dose to 72 hours post-dose|All treated participants with ESRD maintained with hemodialysis||hours||Standard Deviation|Mean
48410|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban|Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants||hours||Standard Deviation|Mean
48411|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants||ng*h/mL||Standard Deviation|Mean
48412|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
48413|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
48414|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
48415|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48416|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48417|NCT01340573|Secondary|Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire|Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.|Week 12|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48418|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48419|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment||Week-48|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48420|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48421|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment|Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48422|NCT01340573|Primary|Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48423|NCT01340573|Primary|Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48424|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up|Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48425|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment|Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-48|The study was terminated early due to low enrollment. This analysis was not performed.|||||
48426|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms During the Day (Response)|"Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline.~5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set||Scores on a scale||Standard Deviation|Mean
48427|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms in the Morning (Response)|"Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline.~5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set||Scores on a scale||Standard Deviation|Mean
48428|NCT01340209|Secondary|Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)|Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.|baseline and week 52|Full analysis set||Puffs||Standard Deviation|Mean
48429|NCT01340209|Secondary|Weekly Mean PEF Variability Response|"Weekly mean PEF variability response was defined as change from baseline at week 52.~The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline."|baseline and week 52|Full analysis set||percentage||Standard Error|Least Squares Mean
48430|NCT01340209|Secondary|Weekly Mean PEFpm Response|Weekly mean PEFpm response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||L/min||Standard Error|Least Squares Mean
48431|NCT01340209|Secondary|Weekly Mean PEFam Response|Weekly mean PEFam response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||L/min||Standard Error|Least Squares Mean
48432|NCT01340209|Secondary|Trough PEF Response|Trough PEF response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||L/min||Standard Error|Least Squares Mean
48433|NCT01340209|Secondary|Trough FVC Response|Trough FVC response was defined as change from baseline at week 52|baseline and week 52|Full analysis set||Liter||Standard Error|Least Squares Mean
48434|NCT01340209|Secondary|Trough FEV1 Response|Trough FEV1 response was defined as change from baseline at week 52|baseline and week 52|Full analysis set: all patients of the treated set for which baseline and at least 1 post-baseline efficacy measurement were available||Liter||Standard Error|Least Squares Mean
48435|NCT01340209|Primary|Number of Patients With Drug-related Adverse Events|The primary endpoint is the number of patients with drug-related adverse events|after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409|Treated set: all randomised patients who received at least 1 dose of study medication||participants|||Number
48518|NCT01339832|Secondary|Type of Adjuvant Chemotherapy|The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
48436|NCT01340196|Secondary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG|"Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.~Preferred term of relevant AE: Presyncope"|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).||participants|||Number
48437|NCT01340196|Secondary|Number of Patients With Drug Related Adverse Events During the Trial|Outcome data are the numbers of subjects with investigator defined drug-related AEs|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).||participants|||Number
48438|NCT01340196|Primary|Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22|Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48439|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48440|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
48441|NCT01340196|Primary|Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15|Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48442|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48443|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects who were documented to have taken at least one dose of trial medication (treated set) who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
48444|NCT01340144|Primary|Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject.|The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication.|Two years after TKA (Total Knee Arthroplasty) procedure|||participants|||Number
48445|NCT01340066|Primary|Percentage of Participants With a Decrease in Leakage Events of 30% or More.|Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period.|Change from baseline after 4 weeks of treatment.|||Percentage of participants|||Number
48446|NCT01340027|Secondary|Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
48447|NCT01340027|Secondary|Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
48448|NCT01340027|Secondary|Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Deviation|Mean
48449|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
48450|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
48451|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|"The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
48452|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
48453|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||participants|||Number
48454|NCT01340027|Secondary|Percentage of Participants With a Health-related Quality of Life Total Score Response|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||percentage of participants|||Number
48455|NCT01340027|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
48456|NCT01340027|Secondary|Percentage of Participants With a Symptom Bother Response|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||percentage of participants|||Number
48457|NCT01340027|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
48458|NCT01340027|Secondary|Percentage of Participants With Deterioration in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||percentage of participants|||Number
48459|NCT01340027|Secondary|Percentage of Participants With Major Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||percentage of participants|||Number
48460|NCT01340027|Secondary|Percentage of Participants With Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.||percentage of participants|||Number
48461|NCT01340027|Secondary|Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set participants with available Baseline and post-baseline data; LOCF imputation was used||units on a scale||Standard Error|Least Squares Mean
48462|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours|Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one nocturia episode at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||nocturia episodes||Standard Error|Least Squares Mean
48463|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours|The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one use of pad at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||pads||Standard Error|Least Squares Mean
48464|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Level of Urgency|Average of participants’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||units on a scale||Standard Error|Least Squares Mean
48465|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||urgency episodes||Standard Error|Least Squares Mean
48466|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence participants who had at least 1 urgency (grade 3 or 4) incontinence episode at Baseline, including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."||urgency incontinence episodes||Standard Error|Least Squares Mean
48467|NCT01340027|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes|The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."||percentage of participants|||Number
48468|NCT01340027|Secondary|Percentage of Participants With Zero Incontinence Episodes Post-baseline|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.|Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."||percentage of participants|||Number
48469|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n)."||incontinence episodes||Standard Error|Least Squares Mean
48470|NCT01340027|Secondary|Percentage of Participants With a Micturition Response|A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants with at least 8 micturitions per 24 hours at Baseline and including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."||percentage of participants|||Number
48471|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n)."||micturitions||Standard Error|Least Squares Mean
48472|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n).."||mL||Standard Error|Least Squares Mean
48473|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set-Incontinence comprised participants in the FAS who reported at least 1 incontinence episode in the baseline diary. LOCF was used.||incontinence episodes||Standard Error|Least Squares Mean
48474|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set; LOCF was used.||micturitions||Standard Error|Least Squares Mean
48475|NCT01340027|Primary|Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set (FAS) comprised all participants took at least 1 dose of double-blind study medication after randomization and had primary efficacy data (mean volume voided) derived from the diary at Baseline and at least 1 post-baseline visit. Last observation carried forward imputation (LOCF) was utilized.||mL||Standard Error|Least Squares Mean
48476|NCT01340014|Secondary|Ocular Discomfort|Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).|Day 7 of each period|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated, minus any missing responses.||Units on a scale||Standard Deviation|Mean
48477|NCT01340014|Primary|Preferred Treatment|"The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer? Preferred treatment is presented as a percentage."|At the end of both periods, Day 15|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated.||Percentage of participants|||Number
48478|NCT01339936|Secondary|Ocular Surface Disease Index Score|"The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient’s ability to function.~The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability."|after 30 days of eye drop usage|||points||Standard Deviation|Mean
48479|NCT01339936|Secondary|Tear Break Up Time|The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35||seconds||Standard Deviation|Mean
48480|NCT01339936|Primary|Tear Film Evaporation Rate|The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10^-7 g/cm^2 /s and recorded for relative humidity of 25% to 35%.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35||10^-7g/cm^2/sec||Standard Deviation|Mean
48481|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on unsolicited safety set.|Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)|Unsolicited safety set||Number of subjects|||Number
48482|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ. Analysis was done on unsolicited safety set.|Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)|Unsolicited safety set||Number of subjects|||Number
48483|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set.|Until 12 months of age; Day 1 to day 7 (All AEs)|Unsolicited safety set||Number of subjects|||Number
48484|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set||Number of subjects|||Number
48485|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set||Number of subjects|||Number
48486|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set||Number of subjects|||Number
48487|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set||Number of subjects|||Number
48488|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set||Number of subjects|||Number
48489|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ|Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set.||Number of subjects|||Number
48490|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence|Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence||IU/mL||95% Confidence Interval|Geometric Mean
48491|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-primary and FAS-booster||IU/mL||95% Confidence Interval|Geometric Mean
48492|NCT01339923|Secondary|GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-persistence and FAS-booster||Titers||95% Confidence Interval|Geometric Mean
48493|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination and 1 month after booster vaccination|FAS-primary series and FAS-booster||Percentages of subjects||95% Confidence Interval|Number
48494|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence||Titers||95% Confidence Interval|Geometric Mean
48495|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination, 1 month after booster vaccination|FAS-primary series and FAS-booster||Titers||95% Confidence Interval|Geometric Mean
48496|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster.|Baseline, 1 month after second vaccination and 1 month after booster vaccination|PPS-primary series and PPS-booster.||Percentages of subjects||95% Confidence Interval|Number
48497|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series||IU/mL||95% Confidence Interval|Geometric Mean
48498|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster.|1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination|FAS-persistence and FAS-booster||IU/mL||95% Confidence Interval|Geometric Mean
48499|NCT01339923|Secondary|Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence||Titers||95% Confidence Interval|Geometric Mean
48500|NCT01339923|Secondary|Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence||Percentages of subjects||95% Confidence Interval|Number
48501|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B_2h3h5_11 and 3rd dose for B_3h5_11 and B_68_11). Analysis was done on FAS-booster.|1 month post-booster dose|FAS-booster||Percentages of subjects||95% Confidence Interval|Number
48502|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose.|Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)|FAS-post first dose||Percentages of subjects||95% Confidence Interval|Number
48503|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV.|Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (after 1 month for group B_2h3h5_11b, 1.5 months for group B_2h3h5_11b and 2 months for group B_68_11b). Analysis was done on FAS-post first dose.|1, 1.5 or 2 months after first infant vaccination|FAS-post first dose||Titers||95% Confidence Interval|Geometric Mean
48504|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV|"Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B_2h3h5_11 and 1 month after 2nd infant vaccination in B_3h5_11, B_68_11 and B_02).~Analysis was done on FAS-primary series."|1 month after primary series vaccination|FAS-primary series||Titers||95% Confidence Interval|Geometric Mean
48505|NCT01339923|Secondary|Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|"Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule).~Analysis was done on FAS- primary series."|1 month after second vaccination|FAS- primary series||Percentages of subjects||95% Confidence Interval|Number
48506|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series||Percentages of subjects||95% Confidence Interval|Number
48507|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series.|1 month after third vaccination|FAS-primary series||Percentages of subjects||95% Confidence Interval|Number
48508|NCT01339923|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.|1 month after second vaccination|FAS-Primary series||Percentages of subjects||97.5% Confidence Interval|Number
48509|NCT01339897|Secondary|Pharmacokinetics of N6022 Cmax Values on Study Day 7|Pharmacokinetic Analysis of N6022 Cmax values on Study Day 7|Day 7, 24 hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48510|NCT01339897|Secondary|Pharmacokinetics of N6022 on Study Day 1|Analysis of N6022 Cmax values on Study Day 1|Day 1, 24 hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48511|NCT01339897|Secondary|Pharmacokinetics of N6022 Over 7 Days|Analysis of N6022 AUC0-tau values from Study Day 7|Day 7, 24 hours|N6022 AUC0-tau values from Study Day 7||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
48512|NCT01339897|Secondary|Pharmacokinetics of N6022|N6022 AUC0-tau measurements from Day 1|Day 1, 24 hours|Any subject that completed N6022 or placebo PK sampling||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
48513|NCT01339897|Primary|Safety of Escalating Multiple Doses of N6022 in Healthy Subjects|Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)|Over 7 days|Any subject that received any dose of N6022 or placebo.||participants|||Number
48514|NCT01339832|Secondary|Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
48515|NCT01339832|Secondary|Long Term Side Effects|Long term side effects for bowel and urinary function was assessed. Bowel function was assessed in terms of mean bowel frequency, regular use of constipating agents as well as fecal incontinence. Urinary function was evaluated according to the presence (YES or NO) of incontinence. Overall participant satisfaction was assessed in terms of satisfaction with bowel, stoma and urinary function on a 4-stage scale (very good, good, poor, and very poor). In case of different assessment(s) of bowel or urinary function within the same surveillance period, the assessment with worst grade was documented and reported.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
48516|NCT01339832|Secondary|Compliance to Diagnostic Procedures in Surveillance|The surveillance compliance was calculated per participant in percent and frequencies for methods of diagnostic procedure adhered to, taking into account all expected procedures in the time span the participant participated and was based on the Swiss Society of Gastroenterology (SGG) follow-up care recommendations|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
48517|NCT01339832|Secondary|Length of Adjuvant Chemotherapy|The length of adjuvant chemotherapy was defined as time between first start date to last stop date of adjuvant chemotherapy regimen. Length of adjuvant chemotherapy was calculated as length [days] = last stop date - first start date + 1, missing day of start and stop date was replaced by 1.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||days||Full Range|Median
49237|NCT01330355|Primary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.||participants|||Number
48519|NCT01339832|Secondary|Tumor Recurrence Rate (Local and Distant)|Participant with tumor recurrence were determined by the presence or absence of date of tumor recurrence detection. In case of absence of empty tumor recurrence date it was considered that the participant had not experienced tumor recurrence. Participants with local tumor recurrence (’Was it local to the primary tumor?’ answered ‘yes’.) compared to participants with distant tumor recurrence (specification for other tumor location given).|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||participants|||Number
48520|NCT01339832|Secondary|Overall Survival|Overall survival (OS) was defined as time from date of first administration of the study medication in ML18280 study to date of death from any cause. Participants without documented date of death were assumed to be alive and were censored at the latest of the following dates: last date alive on survival status pages, last date known to be alive on survival status pages, and last date of tumor assessment (diagnostic procedures or markers) on surveillance pages. OS time in days was calculated as OS [days] =date of death date of first intake+ 1, for participants who died, OS [days]= censoring date date of first intake+ 1, for participants alive, and OS time in months was calculated as OS [months]= 12 *OS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||months||Full Range|Median
48521|NCT01339832|Primary|Progression-free Survival|Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause. In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance). PFS time in days was calculated as PFS [days]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS [days] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS [months]= 12 * PFS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.||months||Full Range|Median
48522|NCT01339429|Secondary|Number of Participants With Serious Adverse Events|Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.|3 days|||participants|Participants||Number
48523|NCT01339429|Primary|Maintenance of Negative Pressure|The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.|3 days|85 dressings were applied. 5 applications excluded due to a change in patient condition, unrelated to sNPWT. 9 dressings excluded due to occlusion of the drainage tube. 71 dressings were analyzed in total.||hours|Participants|Standard Deviation|Mean
48524|NCT01339416|Secondary|Incidence Rate of Death|Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses.|Up to Week 626|Analysis population included all participants enrolled in the study.||death per 100 person-years||95% Confidence Interval|Number
48525|NCT01339416|Secondary|Incidence Rate of Rhabdomyolysis|Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown.|Up to Week 626|Analysis population included all participants enrolled in the study.||rhabdomylosis per 100 person-years||95% Confidence Interval|Number
48526|NCT01339416|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus.|Up to Week 626|Analysis population included all participants enrolled in the study.||viral encephalitis per 100 person-years||95% Confidence Interval|Number
48527|NCT01339416|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.||liver failure per 100 person-years||95% Confidence Interval|Number
48528|NCT01339416|Primary|Incidence Rate of Myocardial Infarction|Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.||MI per 100 person-year||95% Confidence Interval|Number
48537|NCT01339403|Primary|Incidence Rate of Myocardial Infarction and Ischemia|Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||CVS events per 100,000 person-years|||Number
48529|NCT01339416|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.|Up to Week 626|Analysis population included all participants enrolled in the study.||infections per 100 person-years||95% Confidence Interval|Number
48530|NCT01339416|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin’s disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years.|Up to Week 626|Analysis population included all participants enrolled in the study. Here, n=participants who were evaluable for this measure at given time points for each group, respectively.||malignancies per 100 person-years||95% Confidence Interval|Number
48531|NCT01339403|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).|Up to Week 730|Analysis population included all participants enrolled in the study.||VE per 100,000 person-years|||Number
48532|NCT01339403|Primary|Incidence Rate of All-Cause Mortality|Incidence rate of all-cause mortality was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||death per 100,000 person-years|||Number
48533|NCT01339403|Primary|Incidence Rate of Rhabdomyolysis|Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||rhabdomyolysis per 100,000 person-years|||Number
48534|NCT01339403|Primary|Incidence Rate of Liver Related Death|Incidence rate of liver related death was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||death per 100,000 person-years|||Number
48535|NCT01339403|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||liver failure per 100,000 person-years|||Number
48536|NCT01339403|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||infections per 100,000 person-years|||Number
48556|NCT01339000|Primary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on Specific Immune Responses to Vaccines (in Particular to Neo Antigens) in Older Subjects Following Chemotherapy||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
48538|NCT01339403|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.||malignancies per 100,000 person-years|||Number
48539|NCT01339390|Primary|Change in Weight (From Baseline)|Weight as recorded in the medical record during a 6-month period around the follow-up point.|Measured at 12 and 24 months|For the analysis, we included those lost to follow up by using the last observation carried forward to impute missing values||Pounds||Standard Deviation|Least Squares Mean
48540|NCT01339299|Primary|The Oestradiol Concentration on the Day of Ovulation Induction||treatment day 10 to 14|||pmol/L||Standard Deviation|Mean
48541|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||0-120 hours|FAS||percentage of responders||95% Confidence Interval|Number
48542|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1||0-24 hours|FAS||percentage of responders||95% Confidence Interval|Number
48543|NCT01339260|Primary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||25-120 hours|FAS||percentage of responders||95% Confidence Interval|Number
48544|NCT01339247|Primary|Cmax_ss|Cmax_ss is defined as the maximum or “peak” concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population||ng/ml||Standard Deviation|Mean
48545|NCT01339247|Primary|Cmin_ss|Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population||ng/ml||Standard Deviation|Mean
48546|NCT01339247|Primary|AUC_ss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population||ng.h/ml||Standard Deviation|Mean
48547|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
48548|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.||participants|||Number
48549|NCT01339091|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
48550|NCT01339091|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.||participants|||Number
48551|NCT01339013|Primary|Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.|A conventional heat and moisture exchanger used in a respiratory circuit during anasthesia was exchanged by an AnaConDa. The AnaConDa causes re-breathing of carbon dioxide which clinically is equivalent to an increased airway dead space. The total airway dead space effect of the AnaConDa, i.e. volume of the device plus rebreathing from the charcoal filter was measured using the Single Breath Test for carbon dioxide, as was airway deadspace of the conventional Heat and Moisture Exchanger. Airway dead space differences between devices was calculated by subtraction of volumes thus achieved. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger.|1 hour|||mL||95% Confidence Interval|Median
48552|NCT01339000|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|12 months|||participants|||Number
48553|NCT01339000|Secondary|Based on the First Two Primary Objectives, Consider and Discuss the Need for Larger Studies to Evaluate the Potential Benefit of Interleukin-7 (CYT107) Administration in a Broad, Mass Protection Strategy for an Aging Population||1 year|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
48554|NCT01339000|Secondary|Evaluate the Effects of Interleukin-7 (CYT107) Therapy on the Quality of T Cell Specific Responses by Multiparameter Flow Cytometry||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
48555|NCT01339000|Secondary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on the T Cell Receptor Diversity in Older Subjects Following Chemotherapy||10 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.|||||
48557|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% loss in body weight from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
48558|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
48559|NCT01338870|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||kilogram (kg)||Standard Deviation|Mean
48560|NCT01338870|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes, and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
48561|NCT01338870|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||percentage of hemoglobin||Standard Deviation|Mean
48562|NCT01338870|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
48563|NCT01338870|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||percentage of hemoglobin||Standard Deviation|Mean
48564|NCT01338857|Primary|Objective Response Rates|Determination of tumor response (CR, PR, SD) will be defined based on the comparison of the baseline MRI performed at study entry to the subsequent MRI which demonstrated best response. PR will be defined by a >15% decrease in tumor volume, as measured by 3D volumetric analysis.|MRIs performed after every 3rd 28-day cycle and off-study|Study terminated and 1/12 participants completed and data was analyzed||participants|||Number
48565|NCT01338857|Primary|Response Rate to Sorafenib|To estimate the objective response rates to sorafenib in children and young adults with low-grade astrocytomas, including optic pathway gliomas.|one year|Study terminated and 1/12 participants completed and data was analyzed||participants|||Number
48566|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score|SDS,5-self-rated questionnaire to measure the extent a pt’s disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.||Scores on a scale||Standard Deviation|Mean
48579|NCT01338025|Secondary|Number of Participants Non-adherent as Measured by 3-day Recall|Number of participants reporting a missed medication dose in the past 3 days.|28 Weeks|All eligible participants with adherence data available at week 28.||participants|||Number
48580|NCT01338025|Secondary|Change in HIV-1 RNA Levels|Change in HIV-1 RNA levels from Entry to Week 28|28 Weeks|All eligible participants with HIV-1 RNA results available at entry and at week 28.||copies/mL||Inter-Quartile Range|Median
48581|NCT01338025|Secondary|Change in CD4+ T Cell Count|Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).|Entry to week 28|All eligible participants with CD4+ cell count results available at entry and at week 28.||CD4+ T cell count/mL||Inter-Quartile Range|Median
48567|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (rarely or never) to 3 (Very often). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing."|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.||scores on a scale||Standard Deviation|Mean
48568|NCT01338818|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths.|Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.|Week 40 - Week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.||participants|||Number
48569|NCT01338792|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 year|All participants who started treatment were included.||Participants|||Number
48570|NCT01338792|Secondary|Time to Disease Progression and Overall Survival|Progression-free survival was defined as the time from the first infusion of study treatment to the date of radiographic disease progression according to RECIST 1.0, or until two consecutive PSA rises occurred with an absolute increase of 5 ng/mL and a 50% relative increase over baseline. For patients without documented disease progression, the date of death or last follow-up without disease progression was used.|Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progression|Participants who received at least the first infusion of treatment were included.||Months||95% Confidence Interval|Mean
48571|NCT01338792|Primary|Best Overall Response|For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = <30% decrease or <20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.|RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year|All participants who received at least 1 cycle of treatment were included.||Participants|||Number
48572|NCT01338649|Secondary|MSLT and Polysomnograph (PSG) Testing Will be Compared.|MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.|4 weeks||||||
48573|NCT01338649|Secondary|Actigraphy Measures Including Total Sleep Time, Sleep Efficiency, Sleep Fragmentation Index, Frequency of Naps, and Mean Activity Level (a Measurement of Daytime Function) Will be Collected.|Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.|6 weeks||||||
48574|NCT01338649|Secondary|The Global PSQI Score and PDSS Score Will be Compared.|The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.|6 weeks||||||
48575|NCT01338649|Primary|Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.|ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.|baseline and 4 weeks|||score||Standard Deviation|Mean
48576|NCT01338610|Primary|Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28|An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).|Up to 28 days|All subjects randomized to treatment and receiving at least 1 administration of study medication (intent-to-treat). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.||Units on a scale x days||Standard Error|Least Squares Mean
48577|NCT01338493|Secondary|Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)|"Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced.~0 = no pain, 10 = worst possible pain"|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.||units on a scale||95% Confidence Interval|Mean
48578|NCT01338493|Primary|Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.||units on a scale||95% Confidence Interval|Mean
48582|NCT01338025|Primary|Number of Participants With Immunologic Deterioration|"Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:~greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or~development of CDC class C events.~Results report number of participants with immunologic deterioration at week 28 calculated."|From entry to week 28|All eligible participants who entered the study were included in analyses. One participant on Arm A did not meet entry eligibility criteria; was taken off study after the entry visit, and is therefore excluded from all analyses.||participants|||Number
48583|NCT01337960|Secondary|Anticipatory Postural Adjustments|During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|These data were not collected due to technical issues.|||||
48584|NCT01337960|Secondary|Dynamic Gait Index|The Dynamic Gait Index (DGI) assesses individual’s ability to modify balance while walking in the presence of external demands. Performed with a marked distance of 20 feet . The DGI can be performed with or without an assistive device. Scores are based on a 4-point scale: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; 0 = Severe impairment. The highest possible score is 24 points. asks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; Stair climbing.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||units on a scale||Standard Error|Mean
48585|NCT01337960|Secondary|Berg Balance Scale|14-item scale to assess balance function and fall risk, 56 is top score possible (0-56); higher scores indicate higher balance function. Items assess static and dynamic activities of varying difficulty; they are performed to evaluate global level of balance function. Item-level scores range from 0-4, determined by ability to perform the assessed activity; item scores are summed to create the overall score. Subscales are not analyzed.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||units on a scale||Standard Error|Mean
48586|NCT01337960|Secondary|Gait Kinetics|Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||Newton-seconds||Standard Error|Mean
48587|NCT01337960|Primary|Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention|Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.||cm/sec||Standard Error|Mean
48588|NCT01337739|Secondary|Time to Discharge|Time to discharge from the Post Anesthesia Care Unit or home or to hospital room.|24 Hours|||minutes||Standard Deviation|Mean
48589|NCT01337739|Primary|The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.|The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.|Interoperative period|||Total Morphine Equivalents mg||Standard Deviation|Mean
48590|NCT01337674|Secondary|Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618|Blood samples were collected on Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose for the determination of plasma MK-4618 concentration. The hypothesis for this outcome is that the steady-state AUC0-24hr for MK-4618 is >=0.47 uM*hr.|Predose and up to 24 hours postdose on Day 7|The Per Protocol population included participants who complied with the protocol sufficiently to ensure that the data will likely exhibit the effects of treatment, according to the underlying scientific model.||uM*hr||90% Confidence Interval|Geometric Mean
48591|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.||mmHg||95% Confidence Interval|Mean
48592|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.||mmHg||95% Confidence Interval|Mean
48593|NCT01337674|Primary|Percentage of Participants With a Clinical or Laboratory Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded.|Up to 42 days|The All Subjects as Treated population included all participants who received >=1 dose of study drug||Percentage of participants|||Number
48594|NCT01337635|Secondary|Time to Restart Topical Steroids|The time to restart topical steroids and the SCORAD score at time of restart will be secondary study endpoints.|2 years||||||
48595|NCT01337635|Primary|Atopic Dermatitis Severity at the Completion of Treatment|The SCORAD (Severity Scoring of Atopic Dermatitis) is a clinical measurement tool assessing the severity of atopic dermatitis. The range of SCORAD measurements is 0 (best possible outcome) - 103 (worst possible outcome). The primary study endpoint will be the SCORAD score at the end of the 6 week treatment period.|6 weeks|||units on a scale||Full Range|Mean
48596|NCT01337609|Secondary|Patient Global Impression of Change (PGI-C) - IBS Symptoms|The PGI-C is a self-administered measure of the degree of improvement in IBS symptoms compared to the first study visit. Degree of improvement in IBS symptoms from first to final visit will be assessed using this scale.|Administered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
48597|NCT01337609|Secondary|Adequate Relief of IBS Pain (AR-IBS)|The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.|Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
48598|NCT01337609|Secondary|Visual Analog Scale (VAS)|The VAS is a self-administered measure of abdominal pain, discomfort, and bloating. The change in total score from baseline to study endpoint will be assessed.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
48599|NCT01337609|Secondary|IBS Severity Scoring System (IBS-SSS)|The IBS-SSS is a validated instrument used to assess common IBS symptoms over the past 10 days including abdominal pain, distention, bowel habit, and global function. The IBS-SSS will be used to assess the absolute change in specific IBS symptoms at endpoint, namely the bloating/distension score.|Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
48600|NCT01337609|Primary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)is a self report measure that addresses depressive symptoms. MDD responders will be defined as those exhibiting a 50% decrease in the QIDS SR at study endpoint.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.|||||
48601|NCT01337336|Secondary|Number of the Indicated COPD-related Exacerbations|The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).||number of exacerbations||Standard Deviation|Mean
48602|NCT01337336|Secondary|Mean Annual COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).||United States (US) dollars||Standard Deviation|Mean
48603|NCT01337336|Secondary|Number of Participants With the Indicated COPD-related Exacerbations|The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintanance medication for COPD (index date).||participants|||Number
48604|NCT01337336|Primary|Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation|The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).||participants|||Number
48605|NCT01337297|Secondary|State of Depression|It will be applied Hamilton Scale for Depression, a structured multiple choice questionnaire used to assess the severity of the symptoms of depression. It will be applied with cognitive tests.|Before the first experimental session, in the middle of the treatment and after the last experimental session.||||||
48606|NCT01337297|Secondary|Cognitive Tests|Cognitive tests are comprised by frontal assessment battery (FAB), Mini-Mental Status Examination (MMSE), verbal n-back task, visuospatial n-back task, go/no-go test.|Before the first experimental session, in the middle of the protocol and two days after the last experimental session||||||
48607|NCT01337297|Secondary|Event Related Potentials|Event Related Potentials (ERPs) elicited by random presentation of three related images and three non-related images to crack use every Monday and Friday over the two-weeks period of active-tDCS or sham-tDCS.|twice a week over two consecutive weeks during the treatment||||||
48610|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 181 days after any infant vaccination (up to 12 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
48611|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 15 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
48612|NCT01337167|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.||Percentage of participants|||Number
48613|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after each infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
48614|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
48615|NCT01337167|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.||Percentage of participants|||Number
48616|NCT01337167|Secondary|Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||units/mL||95% Confidence Interval|Geometric Mean
48617|NCT01337167|Secondary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||μg/mL||95% Confidence Interval|Geometric Mean
48618|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48619|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48620|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48621|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||EU/mL||95% Confidence Interval|Geometric Mean
48803|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).|1 hour|||Breaths Per Minute||95% Confidence Interval|Mean
48622|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48623|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48624|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48625|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.||Percentage of participants||95% Confidence Interval|Number
48626|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48627|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48628|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48629|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||EU/mL||95% Confidence Interval|Geometric Mean
48630|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48631|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48632|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48653|NCT01337050|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
48633|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48634|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48635|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48636|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48637|NCT01337167|Primary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48638|NCT01337167|Primary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 International unit (IU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48639|NCT01337167|Primary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 milli International units (mIU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48640|NCT01337167|Primary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer >=0.15 μg/mL and >=1.0 μg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.||Percentage of participants||95% Confidence Interval|Number
48641|NCT01337115|Primary|VAS Results - Pain Scores Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 24h after surgery .~VAS scale:~0 - no pain 100 - worst possible pain"|24h after surgery|In the CFNB group 2 patients did not complete the protocol. Analysis was made in an ITT manner and Last Observational Carried Forward (LOCF) was the imputation technique used. In the SNB group, all 25 patients completed the protocol||units on a scale||Standard Deviation|Mean
48642|NCT01337115|Primary|VAS Results - Pain Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 12h after surgery .~VAS scale:~0 - no pain 100 - worst possible pain"|12h after surgery|All 25 patients in each arm completed the protocol. Analysis was made in an ITT manner.||units on a scale||Standard Deviation|Mean
48643|NCT01337115|Secondary|Satisfaction With Anesthesia Technique in Each Arm of the Study|"Satisfaction with the anesthesia technique using a categorical scale with three levels:~Bad Reasonable Good/Very Good A Fisher's Exact test is made to asses any differences in the distribution of patients in each arm to each level of the categorical scale"|1 month after surgery|Analysis was performed on Participants available for telephone contact one month after surgery and was made per protocol.||participants|||Number
48644|NCT01337115|Primary|Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)|Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain|15-30 min after arrival on post anesthesia care unit (PACU)|Participants were analyzed in an Intention to treat (ITT) manner. All randomized subjects (25 in each arm) completed the protocol so all were included for analysis as planned.||units on a scale||Standard Deviation|Mean
48645|NCT01337076|Primary|CNC Monosyllabic Word Score - Treated Ear|"The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements.~CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet."|Six months|||percent correct||Full Range|Mean
48646|NCT01337050|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization or the first dose date plus 1) divided by 30.44). PFS was calculated using the median, and 95% Confidence Intervals (CIs) and Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||months||95% Confidence Interval|Median
48647|NCT01337050|Secondary|Number of Participants With Clinical Benefit Response (CBR)|Number of participant with clinical benefit response (CBR): CBR was defined as CR, PR, SD >12 weeks, SD<12weeks or PD according to RECIST criteria; Complete response (CR): disappearance of all lesions, Pathological lymph nodes’ reduction in short axis (SA) to <10 mm; Partial response (PR): >=30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
48648|NCT01337050|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST); Complete response (CR): disappearance of all lesions, Pathological lymph nodes’ reduction in short axis (SA) to less than (<)10 millimeter (mm); Partial response (PR): greater than equal to (>=) 30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start. Confirmed response=that persist at least 4 weeks after initial documentation.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
48649|NCT01337050|Secondary|Number of Participants With Human Anti-Human Antibody (HAHA)|HAHA analysis was performed using validated, sensitive and specific chemiluminescence enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline, Post-dose (Day 1 of every Cycle up to 28 days after last dose) up to Cycle 30|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
48650|NCT01337050|Secondary|Soluble Proteins Level|Soluble proteins related to Activin Receptor-Like Kinase 1 (ALK-1) signaling and angiogenesis signaling including Vascular adhesion molecule (VAM), Monocyte chemotactic protein 1 (MCP-1), Angiopoietin 2, Tear intercellular adhesive molecule 1 (ICAM-1), Soluble intracellular adhesion molecule 1 (SIAM-1), Soluble vascular adhesion molecule 1 (SVAM-1), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Soluble vascular endothelial growth factor- Receptor 1 (REC 1) (SVEGF-REC 1), Soluble vascular endothelial growth factor- REC 2 (SVEGF-REC 2), Soluble vascular endothelial growth factor- REC 3 (SVEGF-REC 3), Bone morphogenetic protein-9 (BMP-9), Endoglin, Transforming growth factor- beta 1 (TGF- Beta 1), Placental growth factor (PGF) was evaluated.|Baseline, Day 1, 0 hour (H), 6 H Cycle 1 Day 1, Day 22 of Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3 and end of treatment (up to cycle 30)|Biomarker analysis population included all enrolled and treated participants with baseline and on-treatment biomarker sample analyzed. Here “n”= participants who were evaluable for specified biomarker at given time point for each arm, respectively.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
48651|NCT01337050|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||days||Standard Deviation|Mean
48652|NCT01337050|Secondary|Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liter (L)||Geometric Coefficient of Variation|Geometric Mean
48654|NCT01337050|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) for drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
48655|NCT01337050|Secondary|Area Under the Curve From Time Zero to 28 Days [AUC (0-28)]|AUC (0-28)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28).|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
48656|NCT01337050|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.||hours (hr)||Full Range|Median
48657|NCT01337050|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
48658|NCT01337050|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|Pharmacokinetic (PK) parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
48659|NCT01337050|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormalities were segregated into hematology, chemistry, coagulation and urinalysis test. It had been graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) into Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life-threatening). Participants with abnormality of any of these grades are reported.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
48660|NCT01337050|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (non-SAEs). Relatedness to study drug was assessed based on investigator's discretion.|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
48661|NCT01337050|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 1 (Mild Adverse Event), Grade 2 (Moderate Adverse Event), Grade 3 (Severe Adverse Event), Grade 4 (Life- Threatening or Disabling Adverse Event), Grade 5 (Death Related to Adverse Event).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
48662|NCT01337050|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious adverse events (non-SAEs).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
48663|NCT01337050|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.|Baseline up to 28 days after last dose of study medication|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg/kg|||Number
48664|NCT01337050|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than [< ])500/cubic millimeter [mm^ 3]) lasting for greater than equal to (>=) 8 days; Febrile Neutropenia >= Grade 3; Neutropenic Infection >= Grade 3; Grade 4 thrombocytopenia (<25,000/mm^3); Grade 3 thrombocytopenia (<50,000/mm^3) with active bleeding; Grade 3 or higher non-hematological toxicity.|Baseline up to Week 6|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||mg/kg|||Number
48749|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
48665|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
48666|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
48667|NCT01336738|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||kilogram (kg)||Standard Deviation|Mean
48668|NCT01336738|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.||percentage of participants|||Number
48669|NCT01336738|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||percentage of hemoglobin||Standard Deviation|Mean
48670|NCT01336738|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
48671|NCT01336738|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.||percentage of hemoglobin||Standard Deviation|Mean
48672|NCT01336712|Secondary|Cumulative Incidence of Chronic Graft-versus-host Disease||2 year|||percentage of patients analyzed|||Number
48673|NCT01336712|Secondary|Relapse Rate||2 year|||percentage of patients analyzed|||Number
48674|NCT01336712|Secondary|Non-relapsed Mortality (NRM) Percentage||2 year|||percentage of patients|||Number
48675|NCT01336712|Secondary|Disease Free Survival (DFS) Percentage||2 year|||percentage of patients analyzed|||Number
48676|NCT01336712|Secondary|Percentage of Participatns With Donor Chimerism Post-transplant|Characterize donor hematopoietic chimerism in peripheral blood at day 30 after HSCT.|Day 30|||percentage of patients|||Number
48677|NCT01336712|Secondary|Survival|To obtain estimate of overall survival (OS)|2 year|||percentage of patients analyzed|||Number
48678|NCT01336712|Primary|Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant|1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.|6 months|||percentage of patients|||Number
48679|NCT01336647|Secondary|Safety and Tolerability of Ha44 Gel|The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.|From treatment to last visit of the study at 14 days|All subjects who participated||participants with treatment related AEs|||Number
48680|NCT01336647|Primary|Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit||Follow up visit at days 1, 7 and 14 days|Intent to Treat||participants|||Number
48681|NCT01336608|Secondary|Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 24 (Visit 6) each morning and prior to taking study medication (i.e., single-blind and double-blind study medication) supplemental medication (albuterol [salbutamol] if received) and ipratropium bromide (if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Analysis was performed using an analysis of covarience (ANCOVA) model with covariates of treatment, BL mean of occasions of rescue medication use (Week -1), history of exacerbation, and geographical region.|BL (Week -1), Week 1 to Week 24|ITT Population: all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.||Occasions per 24 hours||Standard Error|Least Squares Mean
48682|NCT01336608|Secondary|Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry at Screening, Days 1, 28, 84, 126, and 168. BL FEV1 was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 was defined as the mean of the FEV1 values obtained 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was preformed using a repeated measures model with covariates of visit, treatment, history of exacerbation strata, geographical region, BL FEV1 and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters (L)||Standard Error|Least Squares Mean
48683|NCT01336608|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young’s modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||meters per second (m/sec)||Standard Error|Least Squares Mean
48684|NCT01336569|Primary|Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)|As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.|Baseline, up to 6 weeks|Intent-to-Treat (ITT): All participants who received study medication and had at least one on-therapy study visit.||millimeters mercury (mmHg)||Standard Deviation|Mean
48685|NCT01336296|Secondary|Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection||1 year|||participants|||Number
48686|NCT01336296|Secondary|Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff ‘97|The Banff features suggestive of chronic rejection were: a) chronic transplant glomerulopathy: Glomerular basement membrane duplication and mesangial cell proliferation, and b) vasculopathy: Fibrous intimal thickening often with fragmentation of internal elastic lamina. Chronic changes in the interstitium (ci), tubules (ct), vessels (cv), and glomerulus (cg) were likewise graded into 0, 1, 2, and 3. The severity of interstitial fibrosis and tubular atrophy, as also chronic transplant glomerulopathy and vasculopathy were used to grade chronic allograft changes.|1 year|||participants|||Number
48687|NCT01336296|Secondary|Difference in Renal Function|"Difference in renal function between groups at listed time points assessed by mean serum creatinine. Increased serum creatinine could indicate worsening renal function. A normal serum creatinine range for the transplant population varies by patient, but a typical range for Scr would be 1-2 mg/dL."|Difference at 1 month, 3 months, 6 months, 1 year|||mg/L||Standard Deviation|Mean
48688|NCT01336296|Secondary|Severity of Acute Rejection by Banff '97 Criteria|"Severity of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 1 year. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~As with humoral rejection, there are both acute & chronic forms:~The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).~Class IB: just like Class IA except there is more severe tubulitis.~Class IIA: there is mild-to-moderate intimal arteritis.~Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.~Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|Severity 1 year post transplant|||participants|||Number
48689|NCT01336296|Primary|Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant|"Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~As with humoral rejection, there are both acute & chronic forms:~The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).~Class IB: just like Class IA except there is more severe tubulitis.~Class IIA: there is mild-to-moderate intimal arteritis.~Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.~Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|3, 6 and 12 months post transplant|||participants|||Number
48690|NCT01336205|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.||Participants|||Number
48750|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||mL||Standard Error|Mean
48691|NCT01336205|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.||Participants|||Number
48692|NCT01336205|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.||Participants|||Number
48693|NCT01336140|Secondary|Patients With Recorded Aminophylline Related Major Adverse Events|Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure < 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.|Within 24 hours from the intervention.|All patients.||participant|||Number
48694|NCT01336140|Secondary|Global Symptom Score (GSS) of Regadenoson Related Adverse-effects|"GSS is the sum of severity-weighted (0 = none, 1 = mild, 2 = moderate, 3 = severe) regadenosnon-related adverse-effects of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.~GSS is calculated by weighting each side effect from 0 - 3 (as above) then add the severity weighted scores of all adverse effects (total of 10 as above).~The number of adverse effects contributing to the score is 10, each has a potential severity weight of 0 (absent) to 3 (severe). Thus:~Minimum possible Global Symptom Score (GSS) = 0 Maximum possible Global Symptom Score (GSS) = 30"|Within 2 hours from the intervention.|All patients.||Global Symptom Score||Standard Deviation|Mean
48695|NCT01336140|Secondary|Number of Patients With Any (One or More) Regadenoson-related Adverse-effect|"Regadenoson-related adverse-effects include: flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.~When multiple adverse effects are reported, only one event is counted."|Within 2 hours from the intervention.|All patients.||Participants|||Number
48696|NCT01336140|Primary|Diarrhea (as Reported by the Patient)|"Number of patients who report any incident of diarrhea. Patients will be surveyed for incidents of diarrhea following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory (typically within 2 hours from stress completion).~The primary endpoint encompasses the number of patients with reported symptoms of diarrhea, not the number of bowel movements."|Within 2 hours from the intervention|All patients.||participants|||Number
48697|NCT01335997|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.|||||
48698|NCT01335997|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.|||||
48699|NCT01335867|Secondary|Depression and Anxiety|Measures of depression and anxiety will be assessed using the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale|8 weeks||||||
48700|NCT01335867|Secondary|Alcohol and Cocaine Withdrawal Severity|Measures of alcohol and cocaine withdrawal severity will include Clinical Institutes Withdrawal Scale for Alcohol and Cocaine Selective Severity Assessment|8 weeks||||||
48701|NCT01335867|Secondary|Disease Severity and Improvement|Measures of disease severity and improvement will include the Clinical Global Impression Scale|8 weeks||||||
48702|NCT01335867|Secondary|Addiction Severity|Measures of addiction severity will include the Addiction Severity Index (ASI)|8 weeks||||||
48703|NCT01335867|Secondary|Measures of Cocaine and Alcohol Craving|Measures of cocaine and alcohol craving will be measured using the Minnesota Cocaine Craving Scale and the Penn Alcohol Craving Scale|8 weeks||||||
48704|NCT01335867|Primary|More Alcohol Abstinent Days and Fewer Heavy Drinking Days|The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.|8 weeks|||Days Heavy Drinking|||Number
48705|NCT01335867|Primary|Number of Participants With a Reduction in Cocaine Use|The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples.|3 weeks|||participants|||Number
48706|NCT01335789|Primary|Stress (as Measured by Subjective Report)|Subjective report of stress was measured using a 0-10 Likert Scale (0=not at all, 10=extremely). Reported here is subjective stress level 5 minutes following exposure to the Trier Social Stress Task (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion|||units on a scale||95% Confidence Interval|Mean
48707|NCT01335789|Secondary|Craving (as Measured by the Marijuana Craving Questionnaire)|The MCQ is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1–7 with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. Reported here is MCQ composite score 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion|||units on a scale||95% Confidence Interval|Mean
48708|NCT01335789|Primary|Stress (as Measured by Cortisol)|Salivary cortisol samples were collected via passive drool to provide empirical assessment of stress reactivity. Reported here is salivary cortisol level 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion|||nmol/L||95% Confidence Interval|Mean
48709|NCT01335750|Primary|Corneal Staining Area|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.||units on a scale||Standard Deviation|Mean
48710|NCT01335750|Primary|Corneal Staining Severity|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.||units on a scale||Full Range|Mean
48711|NCT01335750|Secondary|Subjective Dryness|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)||units on a scale||Standard Deviation|Mean
48712|NCT01335750|Secondary|Subjective Comfort|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)||units on a scale||Standard Deviation|Mean
48713|NCT01335724|Secondary|Neck Disability Index|"Neck Disability Index total score. Minimum = 0 Best. Maximum = 50 Worst"|96h|||Total Score||Standard Deviation|Mean
48714|NCT01335724|Secondary|Pain at Rest|"Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|96h|||mm||Standard Deviation|Mean
48715|NCT01335724|Primary|Pain on Movement|"Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|48 h|||mm||Standard Deviation|Mean
48716|NCT01335698|Secondary|Number of Participants With Emergent Genotypic Substitutions|Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level >200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level <50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and <1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor|Baseline through Week 48|All participants with virologic failure.||Participants|||Number
48717|NCT01335698|Secondary|CD4 Cell Count Changes From Baseline|Last observation carried forward: missing values are replaced with the last on-treatment value in the previous visit window;if a patient does not have an on-treatment value, baseline value is carried forward. Baseline observation carried forward: missing values are replaced with the baseline value; if a patient does not have a baseline the first on-treatment value is carried forward.|Baseline to Weeks 24 and 48|All participants with both baseline and time point results||Cells/mm^3||Standard Error|Mean
48718|NCT01335698|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality|Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug. n=number of participants evaluable||Participants|||Number
48719|NCT01335698|Primary|Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event|The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug.||Participants|||Number
48720|NCT01335698|Primary|Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug||Participants|||Number
48721|NCT01335698|Secondary|CD4 Percent Changes From Baseline||Baseline to Weeks 24 and 48|All participants with both baseline and time point results; n=number of participants evaluable at time point||Percent change||Standard Error|Mean
48722|NCT01335698|Secondary|HIV RNA Changes From Baseline||Baseline to Weeks 24 and 48|All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results||Log copies per millileter||Standard Error|Mean
48723|NCT01335698|Secondary|Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort|Virologic success includes patients with HIV RNA <50 copies/mL. Two cohorts were assess: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment.|Day 1 of treatment to Weeks 24 and 48|For efficacy of atazanavir powder to Week 24: Atazanavir Powder Cohort. For efficacy of atazanavir powder efficacy to Week 48 (n): Eligible Week 48 Atazanavir Powder Cohort||Participants|||Number
48724|NCT01335542|Primary|"The Primary Outcome is Time Until a Patient is Ready for Discharge."|"The primary outcome is time until a patient is ready for discharge. Discharge criteria are:~PCA (if present) has been discontinued~Not experiencing moderate or severe nausea (within last 4 hours).~Solid food diet~Able to urinate (Foley catheter removed)~Pain: NRS <4.~Surgical wound dry~No acute medical problems~Physical Therapy Criteria~Independently transfer from supine to sit, from sitting to standing~Ambulate 40 ft. without assistance~Extension range of motion (< 10 degrees)"|Participants will be followed for the duration of their hospital stay, an expected average of 3 days|||days||Inter-Quartile Range|Mean
48725|NCT01335477|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||mmol/min/kPa||Standard Error|Mean
48726|NCT01335477|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent of oxygen saturation||Standard Error|Mean
48727|NCT01335477|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set||percentage of participants|||Number
48728|NCT01335477|Secondary|Time to Death or Lung Transplant Over 52 Weeks|Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period).|52 weeks|Treated Set||percentage of participants|||Number
48729|NCT01335477|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set||percentage of participants|||Number
48730|NCT01335477|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set||percentage of participants|||Number
48731|NCT01335477|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period)."|52 weeks|Treated Set||percentage of participants|||Number
48732|NCT01335477|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set||Participants/Year *100|||Number
48733|NCT01335477|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set||points on a scale||Standard Deviation|Mean
48734|NCT01335477|Secondary|Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
48735|NCT01335477|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA- Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48736|NCT01335477|Secondary|Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48737|NCT01335477|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48738|NCT01335477|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48739|NCT01335477|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48740|NCT01335477|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48741|NCT01335477|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48742|NCT01335477|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks.~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|baseline and 52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
48743|NCT01335477|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
48744|NCT01335477|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set||percentage of participants||95% Confidence Interval|Number
48745|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)||percentage of participants|||Number
48746|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)||percentage of participants|||Number
48747|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
48748|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||%predicted||Standard Error|Mean
48751|NCT01335477|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set||percentage of participants|||Number
48752|NCT01335477|Secondary|Change From Baseline in Saint George’s Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48753|NCT01335477|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate."|52 weeks|Treated Set||mL/year||Standard Error|Mean
48754|NCT01335464|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||mmol/min/kPa||Standard Error|Mean
48755|NCT01335464|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percent of oxygen saturation||Standard Error|Mean
48756|NCT01335464|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48757|NCT01335464|Secondary|Time to Death or Lung Transplant Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48758|NCT01335464|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48759|NCT01335464|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48760|NCT01335464|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period) ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48761|NCT01335464|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||Participants/Year *100|||Number
48762|NCT01335464|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient’s health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Deviation|Mean
48763|NCT01335464|Secondary|Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
48764|NCT01335464|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA-Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48765|NCT01335464|Secondary|Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48766|NCT01335464|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48767|NCT01335464|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48768|NCT01335464|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on scale||Standard Error|Mean
48769|NCT01335464|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48770|NCT01335464|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48771|NCT01335464|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
48772|NCT01335464|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
48773|NCT01335464|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants||95% Confidence Interval|Number
48774|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)||percentage of participants|||Number
48775|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)||percentage of participants|||Number
48776|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
48777|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||% predicted||Standard Error|Mean
48778|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||percent change||Standard Error|Mean
48779|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||mL||Standard Error|Mean
48780|NCT01335464|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days~New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit~Exclusion of infection as per routine clinical practice and microbiological studies~Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)||percentage of participants|||Number
48781|NCT01335464|Secondary|Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint.~SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)||points on a scale||Standard Error|Mean
48782|NCT01335464|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate"|52 weeks|TS (Only patients with observed cases (OC) values were analysed)||mL/year||Standard Error|Mean
48783|NCT01335230|Primary|Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.|We measure gene transcription of the colon tissues (relative expression fold changes of gene transcription compared to control). No preselected criteria were used to assess the participants. Data were analyzed and compared among each group. Relative expression levels of LEAP-2 (Liver expressed anti-microbial peptide-2) in the four groups were shown in the table below. Detailed of other genes had been published in Shata MT, et al, J. Clin Pathology 2013, Nov 66(11):967-75. PMID 23940131, and Abdel-Hameed et al, J. Acquir Immune Defic Syndr. 2013 Jul 10 PMID: 23846566|One year|All the samples were analyzed for gene array transcriptions and cytokines profiles||relative expression levels||Standard Deviation|Mean
48784|NCT01335191|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|54 weeks|all subjects enrolled||ng/mL||Full Range|Mean
48785|NCT01335061|Secondary|Incidence of Less Than Expected Therapeutic Effect (LETE)|The following criteria are the definitions for LETE in this study: 1. LETE in the On-Demand Setting: LETE occurs in the on-demand setting if 2 successive “No Response” ratings are recorded after 2 successive BeneFIX drug infusions in the absence of confounding factors. 2. LETE in the Prophylaxis Setting: LETE occurs in the prophylaxis setting if there is a spontaneous bleed within 48 hours (≤ 48 hours) after a regularly scheduled prophylactic dose of BeneFIX in the absence of confounding factors. 3. LETE (Low Recovery): LETE can also be lower than expected recovery of FIX in the opinion of the investigator following infusion of BeneFIX in the absence of confounding factors. Each reported occurrence of low recovery LETE was listed.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||Percentage of occurence|||Number
48786|NCT01335061|Secondary|Total Factor Consumption.|The total amount (IU) infused for each infusion recorded were summed to calculate the total factor consumption for each participant. For each infusion, IU/kg was calculated, using the most recently recorded weight measurement and the total factor consumption, divided by number of infusions, and was summarized similarly to average infusion dose (IU). Annualized TFC by weight was reported. Annualized TFC by weight = (Total IU/kg / treatment interval duration)*365.25.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||IU/Kg||Standard Deviation|Mean
48787|NCT01335061|Secondary|Average Infusion Dose.|The mean dose by per infusion by weight (IU/kg) was reported for both prophylaxis and on demand infusions|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||IU/Kg||Standard Deviation|Mean
48802|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).|1 hour|||mm Hg||95% Confidence Interval|Mean
48788|NCT01335061|Secondary|Number of Breakthrough (Spontaneous/Non-Traumatic) Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX.|The number of spontaneous, non-traumatic breakthrough bleeds within 48 hours following a prophylaxis dose of BeneFIX were summarized. If there was more than one bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Three participants experienced 1 spontaneous bleeding episode each within 48 hours of a previous prophylaxis infusion.||Number of breakthrough bleeds|Participants|Standard Deviation|Mean
48789|NCT01335061|Secondary|Number of Nonacog Alfa, Recombinant Factor IX (BeneFIX) Infusions Used to Treat Each Bleeding Episode.|The number of study drug infusions administered to treat a bleed will be calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time). The number of infusions needed to treat a bleed will be classified into the following categories: 1, 2, 3, 4 and >4 infusions. If there were more than one bleed location (e.g., ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.||Number of bleeds requiring infusion|Participants||Number
48790|NCT01335061|Secondary|Response to On-Demand Treatment for All Bleeding Episodes.|Assessment scores on a 4-point Response Scale for an on-demand bleeding episode, as assessed by participant/caregiver or investigator/qualified staff. The 4-point scale assessments are Excellent, Good, Moderate or No response. Responses to number of observations were noted.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Follow-up infusion was only required for 18 participants.||Number of observations with response|Participants||Number
48791|NCT01335061|Primary|Annualized Number of Bleeding Episodes.|The annualized bleed rate (ABR) or the annualized number of bleeding episodes per year, will be derived for each participant for each treatment period by using the following formula: ABR = number of bleeds / (Days on treatment period / 365.25) The number of bleeds for the ABR calculation includes all bleeds requiring treatment with factor IX product during the time on treatment.|2 years|The efficacy analysis set (EAS) was used for the primary efficacy analyses with respect to ABR. It includes all participants who participated in at least one day of the routine prophylaxis period (ie, in the study through at least Visit 4).||Number of bleeds per year||Standard Deviation|Mean
48792|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|"Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|6 hours|||units on a scale||95% Confidence Interval|Mean
48793|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours|||Number of Adverse Events|||Number
48794|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours|||Number of Serious Adverse Events|||Number
48795|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours|||Number of Adverse Events|||Number
48796|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours|||Number of Serious Adverse Events|||Number
48797|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent adverse events occurring through extended dosing.|24 hours|||Number of Events|||Number
48798|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent serious adverse events occurring through extended dosing.|24 hours|||Number of Serious Adverse Events|||Number
48799|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).|"The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|4 hours|||units on a scale||95% Confidence Interval|Mean
48800|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever|The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration|4 hours|||Degree Fahrenheit||95% Confidence Interval|Mean
48801|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).|1 hour|||mm Hg||95% Confidence Interval|Mean
48804|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).|1 hour|||Beats Per Minute||95% Confidence Interval|Mean
48805|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting|The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)|1 hour|||Degree Fahrenheit||95% Confidence Interval|Mean
48806|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.|6 hours|This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen||Number of Events|||Number
48807|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours|||Number of Serious Adverse Events|||Number
48808|NCT01334918|Secondary|Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT|Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT.|Day 1 and Day 2|Full analysis set participants with two or more reversible defects.||percentage of participants|||Number
48809|NCT01334918|Secondary|Number of Participants With Fixed Defects|"Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect.~At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.||participants|||Number
48810|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)|"The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.||participants|||Number
48811|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)|"The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.||participants|||Number
48812|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)|"The number of reversible defects in the LAD categorized into absence or presence of ischemia (0–1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.||participants|||Number
48813|NCT01334918|Secondary|Overall Image Quality of Scans by Modality and Reviewer|Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP).|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.||participants|||Number
48858|NCT01333813|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1)|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.||subjects|||Number
48814|NCT01334918|Primary|Number of Participants With Reversible Defects|"The number of reversible defects categorized into absence or presence of ischemia (0–1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set, defined as all randomized patients with interpretable SPECT and CTP scans as determined by at least two of the three blinded readers.||participants|||Number
48815|NCT01334866|Secondary|Composite Major Adverse Event Rate (Late)|"Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:~Major hemorrhage/bleeding requiring surgical intervention~Aortic complications~Graft vessel revision (GVR)~Transient ischemic attacks (TIA)~Cerebrovascular accidents (CVA)/stroke~Myocardial infarction (MI)~Death"|After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation|||percentage of subjects|||Number
48816|NCT01334866|Primary|Composite Major Adverse Event Rate (Early)|"During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include:~Major hemorrhage/bleeding requiring surgical intervention~Aortic complications~Graft vessel revision (GVR)~Transient ischemic attacks (TIA)~Cerebrovascular accidents (CVA)/stroke~Myocardial infarction (MI)~Death"|During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)|||percentage of subjects||95% Confidence Interval|Number
48817|NCT01334866|Primary|Patency of the Index Graft at 6 Months|"For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results.~The FitzGibbon Scoring system is as follows:~A:Excellent graft with unimpaired runoff (< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to <50% of the grafted coronary artery.~O:Occluded (100% stenosed)"|6 months post-procedure|||percentage of grafts|Participants||Number
48818|NCT01334866|Primary|Procedural Success in a MICS Approach|A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.|At time of procedure (day 1)|||percentage of subjects|||Number
48819|NCT01334866|Primary|Technical Success (Graft Patency) in a MICS Approach|For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.|At time of procedure (day 1)|||percentage of grafts|Participants||Number
48820|NCT01334723|Secondary|BPH-Related Costs for Every 30 Days of 5-ARI Therapy|In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
48821|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
48822|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
48823|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||United States dollars per month||Standard Deviation|Mean
48824|NCT01334723|Secondary|Mean Length of 5-ARI Therapy|In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||days||Standard Deviation|Mean
48825|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||participants|||Number
48826|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population||participants|||Number
48827|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%|Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.|The 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population: participants in the IHCIS database with a diagnosis of benign prostate hyperplasia or enlarged prostate as indicated by ICD-9-CM code on claims (222.2x or 600.xx). Participants were included if they had at least 60 days of 5-ARI therapy during the enrollment period, 6 months of continuous enrollment, and no prior surgery.||participants|||Number
48828|NCT01334710|Secondary|Toxicity Assessment|Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.|28 days from study entry||||||
48829|NCT01334710|Primary|Comparison of MRI/CT Scans to Pre-treatment Scan|Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.|6 months||||||
48830|NCT01334606|Secondary|User Acceptability|"After using each pen needle for three weeks, subjects will be asked to respond Yes or No to the question Were the pen needles used for long acting insulin injections at doses greater than 40 units during this past study period acceptable to you? This outcome measure will be determined for the total subject population as well as for the subset of Lantus users."|End of Period 1 (three weeks) and Period 2 (six weeks)||||||
48831|NCT01334606|Secondary|Relative Injection Pain|"Subjects will complete a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm). The sign of each VAS score will be adjusted for the order of pen needle (PN) use, such that the 8mm short PN is always considered the reference."|End of Period 2 (six weeks)||||||
48832|NCT01334606|Secondary|Percentage of Subjects With at Least One Leakage Event|Leakage will be assessed by the subject after any injections of long-acting insulin of greater than 40 units. Subjects will record in their study diary if they observed insulin leakage from the injection site.|3 weeks per pen needle||||||
48833|NCT01334606|Secondary|Glycemic Control as Measured by Fasting Blood Glucose|The measure of glycemic control will be the percent difference in fasting blood glucose (FBG) assessed at the end of Period 1 and Period 2. The average percent difference in FBG between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusted for baseline FBG. This outcome measure will be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle||||||
48834|NCT01334606|Primary|Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine|The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle|No analysis was performed. The study was terminated due to slow enrollment. The same endpoint was studied and reported in a similar subject population, including Lantus users, in study DBC-11-SQUIR05(NCT01231984)which had a similar design.|||||
48835|NCT01334554|Secondary|Endothelial Function|Endothelial function was measured with flow mediated dilation, percent change|Difference between FMD at baseline and 4 weeks|We detected problems with the ultrasound images obtained to measure flow mediated dilation and therefore only data in 14 subjects in the sildenafil group and in 16 subjects in the placebo were analyzed.||percentage of brachial artery diameter|Participants|Standard Deviation|Mean
48836|NCT01334554|Primary|Insulin Sensitivity|insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test|Insulin sensitivity measured at baseline and 4 weeks after the intervention|||min-1/pmol/mlx10-5||Standard Deviation|Median
48856|NCT01333865|Secondary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score|Number of participants with reduction in ASD symptom severity defined as an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2. The CGI-Improvement is a clinician-rated measure of improvement. Scores range from 1 (very much improved) to 7 (very much worse) for PDD.|Pre-treatment - 12 weeks|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.||participants|||Number
48857|NCT01333865|Primary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)|"Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%.~The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings."|Week 12|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.||participants|||Number
48837|NCT01334515|Secondary|Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST)|Number of patients where best overall response is a complete response (CR)-[disappearance of all target lesions and disappearance of any other measureable disease], a very Good Partial Response (VGPR)- [>90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], or partial Response (PR)- [>= 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], and maintains the response. It is possible that a subject’s response to therapy may not occur until after several months of treatment. In order to prevent bias, the maximum duration of time/treatment over which a subject’s response is to be assessed for determination of the best overall response is after the completion of up to 10 courses.|Every two cycles (each cycle lasts 28 days)|Patients will be evaluable for inclusion in the analysis of response if they have an event at any time on the study or if they complete at least 2 cycles of hu14.18-IL2 therapy. Patients who go off-protocol therapy prior to the completion of 2 cycles due to parent/family choice and/or due to toxicity will not be considered evaluable for response.||participants|||Number
48838|NCT01334515|Primary|Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs)|Test for tolerability and monitor for the occurrence of too many unacceptable DLTs using a two-stage stopping rule: (Stage 1) Accrue 10 patients. If more than 1 experience at least one unacceptable DLT during the first treatment cycle, the regimen will be considered to have unacceptable toxicity, and accrual will be temporarily closed, to review all relevant data and consider modifying the regimen to improve safety. If 1 or no patients have an unacceptable DLT in the first treatment cycle, then continue. (Stage 2) Accrue 20 more patients. If 7 or more experience at least one unacceptable DLT in the first treatment cycle, temporarily close the study for possible dosing-safety modifications. If 6 or fewer have an unacceptable DLT in the first treatment cycle, it is reasonable to assume that the combination therapy is safe.|Up to 10 courses|This outcome measure evaluates the first 30 patients to enroll and who receive at least one dose of hu14.18-IL2.||participants|||Number
48839|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Fractional Catabolic Rates With Stable Isotope During Postprandial Period||6 weeks|||pools/day||Standard Deviation|Mean
48840|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Pool Sizes With Stable Isotope During Postprandial Period||6 weeks|||mg||Standard Deviation|Mean
48841|NCT01334229|Secondary|Measurement of Insulin||6 weeks|||pmol/L||Standard Deviation|Mean
48842|NCT01334229|Secondary|Measurement of Glucose||6 weeks|||mmol/L||Standard Deviation|Mean
48843|NCT01334229|Secondary|Measurement of Glucagon-like Peptide-1 by ELISA||6 weeks|||pmol/L||Standard Deviation|Mean
48844|NCT01334229|Primary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Production Rates With Stable Isotope During Postprandial Period||6 weeks|||mg/kg/day||Standard Deviation|Mean
48845|NCT01334125|Secondary|Number of Participants With Minor, Major, and Nocturnal Hypoglycemia|Comparison of the occurrence of hypoglycemic event requiring a third party assistance (major hypoglycemia) per subject during the study, and minor hypoglycemia (plasma glucose of <60 mg/dL or no measurement), as well as nocturnal hypoglycemia (plasma glucose of ≤60 mg/dL between 11PM and 6AM).|12 months|||participants|||Number
48846|NCT01334125|Secondary|Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time|Comparison of the baseline-adjusted differences in adiponectin/leptin ratio over time between the metformin and the placebo groups. The reported values represented mean adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6 mo, and 9 months|||ratio||95% Confidence Interval|Mean
48847|NCT01334125|Secondary|Baseline Adjusted Changes in Lipid Profile Over Time|Comparison of the baseline-adjusted differences in total cholesterol/high density cholesterol index over time between the metformin and the placebo groups. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months|||ratio||95% Confidence Interval|Mean
48848|NCT01334125|Primary|Baseline Adjusted Hemoglobin A1c Over Time|Comparison of the baseline-adjusted differences in HbA1c between the metformin and placebo groups during the trial. Hemoglobin A1c is a marker of glycemic control. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months|||percentage of HbA1c||95% Confidence Interval|Mean
48849|NCT01333956|Secondary|Satisfaction|Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)|2 weeks|||units on a scale||Inter-Quartile Range|Median
48850|NCT01333956|Secondary|Opioid Usage|Opioid Usage (POD1, POD 3, 2 weeks, 3 months)|3 months|||mg||95% Confidence Interval|Mean
48851|NCT01333956|Secondary|Neuropathic Pain|Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.|3 months|||units on a scale||Inter-Quartile Range|Median
48852|NCT01333956|Secondary|Numeric Rating Scale (NRS)|NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)|3 months|||units on a scale||95% Confidence Interval|Mean
48853|NCT01333956|Secondary|Self-assessed Sedation and Confusion|Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)|1 day postoperatively|||percentage of patients|||Number
48854|NCT01333956|Secondary|Opioid-Related Symptom Distress Score|Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).|2 weeks postoperatively|||units on a scale||Inter-Quartile Range|Median
48855|NCT01333956|Primary|Postoperative Pain|Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).|2 weeks postoperatively|||units on a scale||Standard Deviation|Mean
49293|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 12|ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.|Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.||percentage of participants|||Number
48859|NCT01333813|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.||subjects|||Number
48860|NCT01333813|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and temeperature.~Any temperature was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 temperature was axillary temperature > 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination."|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.||subjects|||Number
48861|NCT01333813|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local symptoms assessed were pain, redness and swelling. Any was occurrence of any local symptom regardless of their intensity grade. Grade 3 pain was considerable pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was > 50 millimeter (mm).|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine .||subjects|||Number
48862|NCT01333813|Secondary|Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose|The anamnestic response is defined as an antibody concentration ≥ 10 mIU/mL at post Engerix-B Kinder challenge dose time point for initially seronegative subjects ,and as an antibody concentration at post Engerix-B Kinder challenge dose time point ≥ 4 fold the pre-vaccination antibody concentration for initially seropositive subjects. A seropositive/seronegative subject was defined as subject with HBs antibody concentration below/greater than or equal to the seropositivity cut-off of 6.2 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|After Engerix-B Kinder challenge dose (Month 1)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||subjects|||Number
48863|NCT01333813|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||mIU/mL||95% Confidence Interval|Geometric Mean
48864|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL) and ≥ 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||subjects|||Number
48865|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL), ≥ 10 mIU/mL, ≥ 10 mIU/mL to <100 mIU/mL and ≥ 100 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.||subjects|||Number
48880|NCT01333436|Secondary|Postprandial Mean ApoB-48 Peak Levels|ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.||μg/mL||Standard Deviation|Mean
49322|NCT01329679|Primary|Change in Office Systolic Blood Pressure|SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.|At baseline and 7 days post energy drink and placebo consumption|||mmHg||Standard Deviation|Mean
48866|NCT01333813|Secondary|Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.|"Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL.~A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis."|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.||mIU/mL||95% Confidence Interval|Geometric Mean
48867|NCT01333813|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.||subjects|||Number
48868|NCT01333722|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||minutes||95% Confidence Interval|Median
48869|NCT01333722|Secondary|SPRID (Pain Relief and Pain Intensity Difference)|"SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
48870|NCT01333722|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
48871|NCT01333722|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
48872|NCT01333592|Primary|Incidences of Adverse Events||52 weeks|||Participants|||Number
48873|NCT01333592|Secondary|Change From Baseline in HbA1c at 52 Weeks||at week 0 and week 52|||percentage of HbA1c||Standard Deviation|Mean
48874|NCT01333488|Secondary|Vasospasm|as measured by TCD (Transcranial Doppler)|up to 3 months|||Percentage of participants|||Number
48875|NCT01333488|Secondary|GOS|GOS score|12 months after injury|||GOS score||Full Range|Mean
48876|NCT01333488|Primary|GOS (Glasgow Outcome Score)|"GOS=5 (Good Recovery) - Capacity to resume normal occupational and social activities, although some there may be some minor physical or mental deficits or symptoms.~GOS=4 (Moderate Disability) - Independent and can resume almost all activities of daily living.~GOS=3 (Severe Disability) - No longer capable of engaging in most previous personal, social or work activities. Typically are partially or totally dependent on assistance from others in daily living.~GOS=2 ( Persistent Vegetative State ) GOS=1 (Dead)"|Discharge from Hospital - Within 2 months from Injury|||units on a scale||Full Range|Mean
48877|NCT01333475|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|29 months, 23 days|||participants|||Number
48878|NCT01333475|Primary|pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer|A predetermined target inhibition reduction of 70% of both pERK and pAKT was deemed significant, thus tumor biopsies were performed at C1D1 or C1D22 post administration and evaluated using quantitative chemiluminescence immunoassay to measure pERK and pAKT levels in human tissue.|C1D1 and C1D22 post administration of the combination of AZD6244 hydrogen sulfate and MK-2206|||pg/ µg of protein||Full Range|Mean
48879|NCT01333436|Secondary|Fasting ApoB-48 Levels|ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).|Baseline (Hour 0)|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.||μg/mL||Standard Deviation|Mean
48881|NCT01333436|Primary|Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)|ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.||μg/mL x h||Standard Deviation|Mean
48882|NCT01333397|Secondary|Percentage of Subjects as Responders at Day 29 by the Investigator’s Live Assessment and by Subject’s Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)||Day 29|ITT Population; N’=number of subjects with an assessment at Day 29||percentage of subjects|||Number
48883|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator’s Live Assessment at Rest (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit||percentage of subjects|||Number
48884|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Subject’s Self Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment||percentage of subjects|||Number
48885|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator’s Live Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment||percentage of subjects|||Number
48886|NCT01333397|Other Pre-specified|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study|Treatment Emergent Adverse Event (TEAE)|Up to Day 113 (±3 days)|Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected||participants|||Number
48887|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
48888|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit||percentage of subjects|||Number
48889|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
48890|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 113|ITT Population; N’=number of responders at Day 29||percentage of subjects|||Number
48891|NCT01333397|Secondary|Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.|A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit;||percentage of subjects|||Number
48892|NCT01333397|Secondary|Percentage of Subjects Assessed as Responders, by Both the Investigator’s Live Assessment and the Subject’s Self-assessment at Maximum Frown.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
48893|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject’s Self-assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
48894|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator’s Live Assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
48895|NCT01333397|Secondary|Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 29|ITT Population; Day 29 (N'=34,36,35,33,35); N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit||percentage of subjects|||Number
48908|NCT01333189|Primary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||ratio||Standard Deviation|Mean
48896|NCT01333397|Primary|Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown|"Investigator’s live assessment (ILA), subject’s self assessment (SSA), Next Generation (NG)~4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3;~4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3;~A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2."|Day 29|Intent-to-Treat Population: The intent-to-treat (ITT) population included all randomised subjects who received study treatment, regardless of the actual amount injected. N’=number of subjects with assessment||percentage of subjects|||Number
48897|NCT01333189|Secondary|Hip, Knee, and Ankle Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||Newton-meters per kilogram (Nm/kg)||Standard Error|Mean
48898|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||meters/second||Standard Deviation|Mean
48899|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
48900|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||seconds||Standard Deviation|Mean
48901|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||ratio||Standard Deviation|Mean
48902|NCT01333189|Secondary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.||ratio||Standard Deviation|Mean
48903|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
48904|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||meters/second||Standard Deviation|Mean
48905|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
48906|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||seconds||Standard Deviation|Mean
48907|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.||ratio||Standard Deviation|Mean
49294|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 24||Week 24|Participants in the Safety Analysis Set with Available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.||percentage of participants|||Number
48909|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Nonresponding Participants Treated With Rituximab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
48910|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Participants Treated With 8 Courses of Tocilizumab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48911|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using FACIT at Week 16|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48912|NCT01332994|Secondary|Quality of Life as Assessed Using Functional Assessment of Chronic Illness Therapy (FACIT)|The FACIT-F evaluates quality of life using 5 categories: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and fatigue (FS). Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-General (FACIT-G; range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-Fatigue (FACIT-F) trial outcome index (TOI; range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48913|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to HAQ-DI Criteria|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Response was defined as a change in index score >0.22 from Baseline to Week 16.|Baseline and Week 16|Main ITT Population||percentage of participants|||Number
48914|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Nonresponding Participants Treated With Rituximab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
48915|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Participants Treated With 8 Courses of Tocilizumab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
48932|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in g/L.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||g/L||Standard Deviation|Mean
48916|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using HAQ-DI at Week 16|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit were included.||units on a scale||Standard Deviation|Mean
48917|NCT01332994|Secondary|Quality of Life as Assessed Using HAQ-DI|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48918|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Nonresponding Participants Treated With Rituximab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48919|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Participants Treated With 8 Courses of Tocilizumab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48920|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using SF-36 at Week 16|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48921|NCT01332994|Secondary|Quality of Life as Assessed Using Short Form 36 (SF-36)|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48922|NCT01332994|Secondary|Mean Number of Work Days Missed Per Week|Work days missed were documented by reason (either rheumatoid arthritis [RA] or other reasons) for each participant over the preceding 7-day period. The mean number of work days missed was calculated by averaging the number of days missed per week among all participants.|Baseline and Week 16|Main ITT Population. Employed participants with evaluable data at the designated visit (number shown = n) were included.||days||Standard Deviation|Mean
48923|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 32, 40, 48, and 66 Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 32, 40, 48, and 66|ITT3 Population; n = number of data pairs included in the analysis.||coefficient|Participants||Number
48933|NCT01332994|Secondary|Change in ESR From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change was calculated as [mean ESR at Week 32 minus mean ESR at Week 16] and expressed in mm/h.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||mm/h||Standard Deviation|Mean
49218|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
48924|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 24, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 24, and 32|ITT2 Population; n = number of data pairs included in the analysis.||coefficient|Participants||Number
48925|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Week 16 Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline to Week 16 in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Week 16|ITT1 Population; n = number of data pairs included in the analysis.||coefficient|Participants||Number
48926|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||percentage of B-cells||Full Range|Median
48927|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||percentage of B-cells||Full Range|Median
48928|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT1 Population: All participants who received at least one dose of TCZ in the first treatment period and who completed the study reaching remission at Week 16. Participants with evaluable data at the designated visit (number shown = n) were included.||percentage of B-cells||Full Range|Median
48929|NCT01332994|Secondary|Percentage of Participants Withdrawing From the Study for Insufficient Therapeutic Response|Study discontinuation was documented by reason for each participant prematurely withdrawing from the study. The percentage of participants was calculated as the number withdrawing for insufficient therapeutic response divided by the total number of participants who began treatment.|Baseline to Week 16|Main ITT Population. Participants who withdrew for reasons other than insufficient therapeutic response were not included in the analysis.||percentage of participants||95% Confidence Interval|Number
48930|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in mm/h.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mm/h||Standard Deviation|Mean
48931|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in mg/dL.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mg/dL||Standard Deviation|Mean
48934|NCT01332994|Secondary|Change in CRP From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change was calculated as [mean CRP at Week 32 minus mean CRP at Week 16] and expressed in mg/dL.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||mg/dL||Standard Deviation|Mean
48935|NCT01332994|Secondary|Change in Hemoglobin From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change was calculated as [mean hemoglobin at Week 32 minus mean hemoglobin at Week 16] and expressed in g/L.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.||g/L||Standard Deviation|Mean
48936|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in millimeters per hour (mm/h).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mm/h||Standard Deviation|Mean
48937|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in milligrams per deciliter (mg/dL).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||mg/dL||Standard Deviation|Mean
48938|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in grams per liter (g/L).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||g/L||Standard Deviation|Mean
48939|NCT01332994|Secondary|Change From Baseline in CDAI and SDAI Scores at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48940|NCT01332994|Secondary|Change From Week 16 to 32 in CDAI and SDAI Scores Among Nonresponding Participants Treated With Rituximab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48941|NCT01332994|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Scores at Weeks 4, 8, 12, and 16|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48942|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population||percentage of participants||95% Confidence Interval|Number
49106|NCT01332071|Primary|Cmax of Rosiglitazone Maleate|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
48943|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from the reference visit (Week 16) of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Weeks 16 and 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
48944|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to American College of Rheumatology (ACR) Criteria at Weeks 4, 8, 12, and 16|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate a swollen joint count (SJC) ranging from 0 to 66 swollen joints and a tender joint count (TJC) ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP); plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
48945|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population||percentage of participants||95% Confidence Interval|Number
48946|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit (Week 16). Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Weeks 16 and 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
48947|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Weeks 4, 8, 12 and 16|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
48948|NCT01332994|Secondary|DAS28 Scores During Safety Follow-Up Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Weeks 40, 48, 56, and 66|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48949|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 24, and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48950|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48972|NCT01332578|Secondary|Time to Onset and Completion of Disintegration of Reference Tablets|Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.|Baseline to 10 hours post dose|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Tablet Disintegration endpoints were only measured in the first period for each participant.||minutes||Standard Deviation|Mean
48951|NCT01332994|Secondary|DAS28 Scores During and After Treatment|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.||units on a scale||Standard Deviation|Mean
48952|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction in DAS28 From Week 16 to Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from the reference visit (Week 16) to the assessment visit were considered clinically relevant.|Weeks 16 and 32|ITT3 Population: All participants who received at least one dose of TCZ in the first treatment period and at least one dose of RTX in the second treatment period with at least one efficacy measurement under RTX.||percentage of participants||95% Confidence Interval|Number
48953|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Weeks 4, 8, and 12|Main ITT Population||percentage of participants||95% Confidence Interval|Number
48954|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Week 16|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Week 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
48955|NCT01332994|Secondary|Percentage of Participants Achieving LDAS According to DAS28 Among Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
48956|NCT01332994|Secondary|Percentage of Participants Achieving Low Disease Activity Score (LDAS) According to DAS28|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
48957|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT3 Population||percentage of participants||95% Confidence Interval|Number
48958|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT2 Population||percentage of participants||95% Confidence Interval|Number
48959|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 16, 20, 24, and 28 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 16, 20, 24, and 28|ITT2 Population: All participants who received at least one dose of TCZ in the first treatment period with at least one efficacy measurement under TCZ, receiving TCZ in the second treatment period.||percentage of participants||95% Confidence Interval|Number
48993|NCT01332435|Secondary|Total BPH-related Costs|All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population||United States dollars||Standard Deviation|Mean
48994|NCT01332435|Primary|Number of Participants Who Needed Prostate-Related Surgery|Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population||participants|||Number
48960|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 4, 8, and 12|Main ITT Population||percentage of participants||95% Confidence Interval|Number
48961|NCT01332994|Primary|Percentage of Participants Achieving Remission at Week 16 According to DAS28|The DAS28 was calculated as [0.28 times (x) the square root of number of swollen joints] plus (+) [0.56 x the square root of number of tender joints] + [0.7 x the natural log of erythrocyte sedimentation rate (ESR)] + [0.014 x Visual Analog Scale (VAS) patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 16|Main ITT Population||percentage of participants||95% Confidence Interval|Number
48962|NCT01332981|Secondary|Prognostic Factors For Time to Progression|Prognostic factors for TTP were searched by using Cox regression model. First, all parameters were analysed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15% level were retained for multivariate model. For multivariate analyses, 2 models were built for prognostic factor of TTP. In Model 1, stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In Model 2, stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for exit was 5%. Six parameters remained in the Model 1 to search for prognostic factors of TTP. Once the correlated variables were removed, there were only 3 variables left in Model 2: the age was not kept by the stepwise selection. Results below are for Model 1 and similar results were obtained for Model 2|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Hazard Ratio||95% Confidence Interval|Number
48963|NCT01332981|Secondary|Prognostic Factors for Overall Survival|Search for prognostic factors for OS was performed using Cox regression model. First, all parameters were analyzed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15%-level were retained for the multivariate model. For the multivariate analysis, two models were built for prognostic factors for OS. In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%. The variables n°5 and n°6 were found to be significantly associated, thus only the variable n°6 was tested in the Model 2. This variable was not retained by the stepwise selection in the Model 1, contrary to the variable n°5.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Hazard Ratio||95% Confidence Interval|Number
48964|NCT01332981|Secondary|Median Treatment Duration and the Duration of Exposure to Trastuzumab|Treatment duration was defined as the time between the first and the last infusion of trastuzumab. Exposure duration was defined only for the participants who continued trastuzumab after HERMINE study, as the sum of treatment duration as part of HERMINE study and of the treatment durations as part of post-HERMINE study taking into account temporary treatment discontinuations. For analyses of treatment and exposure duration , dates of infusion of trastuzumab were missing for 18 participants, so treatment and exposure durations were calculated for only 202 participants.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||Full Range|Median
48965|NCT01332981|Secondary|Median Time to Progression|The Time to Progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. If the cause of death was unknown, the death was considered for this analysis as due to the disease. All participants who did not progress, the death was considered to be due to the disease.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||95% Confidence Interval|Median
48966|NCT01332981|Secondary|Median Time to Progression-Free Survival|The Progression-Free Survival (PFS) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. Progression-Free Survival was estimated by using Kaplan-Meier method.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||95% Confidence Interval|Median
48967|NCT01332981|Primary|Median Overall Survival|The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.||Years||95% Confidence Interval|Median
48968|NCT01332721|Secondary|Objective Response According to RECIST 1.1|The best response according to RECIST 1.1 for each patient with measurable disease and who received at least one dose of study drug will be listed by cohort and tumor type|1.5 years|||participants|||Number
48969|NCT01332721|Secondary|Immune Response to TRC105|HAMA and HACA titers will be measured at specified time-points.|1.5 years|||participants|||Number
48970|NCT01332721|Secondary|TRC105 Pharmacokinetic Concentrations|Plasma TRC105 concentrations will be measured at specified timepoints.|1.5 years||||||
48971|NCT01332721|Primary|Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab|Safety and dose limiting toxicity will be assessed by dose cohort.|1.5 years|||mg/kg|||Number
49295|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 12||Week 12|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
48973|NCT01332578|Secondary|Time to Completion of Gastric Emptying|Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.||minutes||Standard Error|Least Squares Mean
48974|NCT01332578|Secondary|Time to Onset of Gastric Emptying|The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.||minutes||Standard Error|Least Squares Mean
48975|NCT01332578|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time after administration when the maximum plasma concentration was reached.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||hours||Full Range|Median
48976|NCT01332578|Secondary|Maximum Plasma Concentration (Cmax)|Cmax was determined using plasma paracetamol concentration time profile.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||ng/mL||Standard Deviation|Mean
48977|NCT01332578|Secondary|AUC (0-60 Min)|AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||ng*h/mL||Standard Deviation|Mean
48978|NCT01332578|Secondary|Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)|AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||nanograms (ng)*hours (h)/mL||Standard Deviation|Mean
48979|NCT01332578|Primary|Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)|Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.|Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|Modified Intent-To-Treat (MITT) population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.||minutes||Full Range|Median
48980|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
48981|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
48982|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||tablets per participant||Standard Deviation|Mean
48995|NCT01332435|Primary|Number of Participants With Acute Urinary Retention|Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population||participants|||Number
49219|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
48983|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
48984|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||United States dollars||Standard Deviation|Mean
48985|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.||tablets per participant||Standard Deviation|Mean
48986|NCT01332487|Secondary|Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery||6 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed.||participants|||Number
48987|NCT01332487|Primary|Number of Participants Who Experienced Progression of Disease|The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.|Up to 5 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)||participants|||Number
48988|NCT01332461|Secondary|Mean Monthly COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge||United States (US) dollars||Standard Deviation|Mean
48989|NCT01332461|Secondary|Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge||participants per 100 person-years|||Number
48990|NCT01332461|Primary|Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge||participants per 100 person-years|||Number
48991|NCT01332435|Secondary|BPH-related Pharmacy Costs|Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population||United States dollars||Standard Deviation|Mean
48992|NCT01332435|Secondary|BPH-related Medical Costs|Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population||United States dollars||Standard Deviation|Mean
48996|NCT01332435|Primary|Number of Participants With Clinical Progression|Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population: Men aged >=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy||participants|||Number
48997|NCT01332357|Primary|Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event|A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.|Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.||participants|||Number
48998|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Sleep Quality|"The PghSD assessed a participant's previous night's sleep. Sleep quality was assessed using a Visual Analogue Scale (VAS). Participants indicated their sleep quality by marking a vertical line on a horizontal scale anchored by responses very bad and very good. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point that the participant marked. Scores ranged from 0 to 100 mm with higher scores indicating better sleep quality and lower scores indicating worse sleep quality."|Baseline (Day -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."||millimeters||Standard Deviation|Mean
48999|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item|The PghSD assessed a participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning after dose), and 16 (at Tmax)value minus the Baseline (Days -1 and 1) value. Total sleep time is expressed in hours.|Baseline (Days -1 and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."||hours||Standard Deviation|Mean
49000|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items|The PghSD assessed participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning), and 16 (at Tmax of GEn and DPH) value minus the Baseline (Days -1 and 1) value. Latency to sleep onset (time to fall asleep) and wake time after sleep onset are expressed in minutes.|Baseline (Days -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."||minutes||Standard Deviation|Mean
49001|NCT01332318|Secondary|Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep.|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
49002|NCT01332318|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12 PM, 12 PM to 4 PM, 4 PM to 8 PM, 6 PM to 10 PM, 8 PM to 12 Midnight, Midnight to 4 AM, and 4 AM to 8 AM).|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
49003|NCT01332318|Secondary|Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the||percentage of participants|||Number
49004|NCT01332318|Secondary|Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. For Arms 2 and 3, upper limits of the confidence intervals are not available, as they are beyond the 24-hour time frame.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the||participants||95% Confidence Interval|Median
49005|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14|"The participant-rated CGI-I is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale)."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
49236|NCT01330355|Secondary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 3 (Day 3)|The analysis population only includes those for whom the outcome was measured within the specified time frame.||participants|||Number
49006|NCT01332318|Secondary|Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
49007|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14|"The investigator-rated CGI-I is a clinician-rated assessment designed to allow clinicians to rate the change of their participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse compared to baseline. For this endpoint, response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale) compared to baseline."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
49008|NCT01332318|Secondary|Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change of the disease severity over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||participants|||Number
49009|NCT01332318|Secondary|Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day -1) and Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."||scores on a scale||Standard Deviation|Mean
49010|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score|Participants (par.) were asked to look at 2 pictures simultaneously; each picture showed 3 different colored balls arranged on 3 pegs. Par. were to estimate the number of times the balls in 1 picture would have to be moved to make the arrangement of balls identical to that of the second picture. Par. were allowed 20 seconds to respond to each pair of pictures. The number of correct items was the TOL Score (range: 0-22). The TOL scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -7.53 to 2.76; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
49011|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score|Participants were given a list of numbers (numerals 1-9) that were each associated with a unique symbol. Participants decoded a list of 110 symbols as quickly as possible in 90 seconds. The total number of symbols correctly decoded was the Symbol Coding Score (range: 0-110). The Symbol Coding scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -7 to 10.08, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
49012|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score|Verbal Fluency included one semantic fluency and two letter fluency tasks. Participants were given 60 seconds to name as many words as possible within a given semantic category (supermarket items), and in two separate trials, participants were given 60 seconds to generate as many words as possible that began with a given letter. The total number of words from all of the 3 trials was the Verbal Fluency score (range: 0-150). The scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -5 to 10.83; higher scaled scores indicate better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
49013|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score|Participants were given 100 plastic tokens and asked to place them in a container, 2 at a time, as quickly as possible for 60 seconds. The number of tokens correctly placed in the container was the Token Motor Task score (range: 0-100). The BAC was conducted prior to each simulated driving test. The Token Motor Task scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -6.95 to 3.35, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
49135|NCT01332019|Secondary|Volume of T2 Hyperintense Lesions|The volume of T2 hyperintense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||cm^3||Standard Deviation|Mean
49014|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS)|Participants (par.) were presented with sets of numbers of increasing length and asked to tell the experimenter the numbers in order from lowest to highest. The task has 7 levels; the first level had 2 digits in the set (e.g., 5, 2); the second level had 3 digits in the set, etc. The number of times the par. correctly arranged the numbers was recorded as the score for each level. The DSS is the sum of the 7 level scores (range: 0-28). The scaled test score was calculated as indicated for the Verbal Memory Test and ranges from -6.68 to 2.73; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
49015|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score|Participants were presented with 15 words and asked to recall as many as possible; the procedure was repeated 5 times. The total number of words recalled correctly across the 5 administrations of the list was the participant’s Verbal Memory Recall score (range: 0-75). The scaled test score was calculated as ((BAC component raw test score - healthy control sample test mean)/healthy control sample test standard deviation); a healthy control sample was matched to the participant's sex and age category. The scaled test score range is -7.37 to 4.86; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
49016|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score|The BAC was designed as a comprehensive measure of cognitive function, including 6 individual tests: Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London. The composite/total BAC score is calculated by scoring each individual test, comparing each score to a healthy control sample (matched for sex and age category) to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
49017|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score|"The Epworth Sleepiness Scale (ESS) is a questionnaire designed to evaluate daytime sleepiness. Participants were asked to rate how likely they were to doze or fall asleep during 8 activities on a scale of 0 (would never do) to 3 (high chance of dozing). The total score ranges from 0-24, with a score greater than 10 representing excessive daytime sleepiness (an increased chance of dozing). Change from baseline was calculated as the Day 14 total score minus the Baseline total score."|Baseline (Day -1) and Day 14|Modified Intent-to-Treat (MITT) Population||scores on a scale||Standard Deviation|Mean
49018|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score|"Alertness VAS was completed immediately before and after each simulated driving assessment. Participants indicated their alertness by marking a vertical line on a horizontal scale anchored by responses extremely sleepy and extremely alert. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point the participant marked. Scores ranged from 0-100 mm, with higher scores indicating more alertness and lower scores indicating more sleepiness. Change score was calculated as the Day 14, 15, or 16 VAS score minus the Baseline VAS score."|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. Varying numbers of participants did not complete either the pre- or post-drive VAS at either Baseline or the day of assessment; as such, the number of participants analyzed varies by day.||millimeters||Standard Deviation|Mean
49019|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time|Brake reaction time was assessed as the time it took for each participant to move their foot off the accelerator and onto the brake pedal after the appearance of a stop sign on the simulation screen. Change from baseline was calculated as the Day 14, 15, or 16 mean reaction time minus the Baseline (Days -1 and 1) mean reaction time.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||seconds||Standard Deviation|Mean
49020|NCT01332318|Secondary|Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)|A simulated crash was defined as a collision with an oncoming car or obstacle (e.g., tree) or when the distance to the center line was greater than 18 feet on either side of the road.|Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||participants|||Number
49021|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed|Participants were instructed to maintain a speed of 55 miles per hour during the driving assessment. Change from baseline in overall average speed was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||miles per hour||Standard Deviation|Mean
49046|NCT01332292|Primary|Total Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
49022|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability|Speed variability was defined as the standard deviation of the speed (measured in miles per hour). Participants were instructed to maintain a speed of 55 miles per hour during the test drive. Change from baseline in overall speed variability was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed variability over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed variability over the 1-hour drive.|Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||miles per hour||Standard Deviation|Mean
49023|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position|Lane position was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall average lane position was calculated as the Day 14 (in the evening), 15 (in the morning after GEn dosed at 5 PM), or 16 (assessment at Tmax of GEn and DPH) mean lane position over the 1-hour drive minus the Baseline (Days -1 and 1) mean lane position over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||feet||Standard Deviation|Mean
49024|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 14 (in the evening) or Day 15 (in the morning after GEn dosed at 5 PM) mean LPV over the 1-hour drive minus the Baseline (Day -1 or Day 1) mean LPV over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14 and 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.||feet||Standard Deviation|Mean
49025|NCT01332318|Primary|Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH.|Baseline (Day -1) and Day 16|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who completed at least one Baseline and one End of Study (Days 14-16) simulated driving assessment. The number of participants assessed at each study day varies due to incomplete/missing data.||feet||Standard Error|Least Squares Mean
49026|NCT01332305|Primary|Mean AUCss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.|Weeks 4 and 12|Safety Population. Placebo participants were not included in the PK assessments, as they had no exposure to GEn. Of participants who completed the study, some were not included at Week 12 (sample not taken or below limit of quantitation).||ng*hour/ml||Standard Deviation|Mean
49027|NCT01332305|Primary|Mean Tmax and T1/2|Tmax is defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.|Weeks 4 and 12|Safety Population. Placebo participants (par.) were not included in the PK assessments, as they had no exposure to GEn. At W4, there were two par. excluded from the T1/2, as a result of no sample taken or a PK profile not possible. Of par. who completed the study, some were not included at W12 (sample not taken or below limit of quantitation).||hours||Standard Deviation|Mean
49028|NCT01332305|Primary|Mean Css, Max and Css, Min|Css, max is defined as the maximum or “peak” concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.|Weeks 4 and 12|Safety Population: all participants (par.) who were randomized and received at least one (or any portion of a) dose of study drug. Population was analyzed as randomized. Placebo par. had no exposure to GEn and were not included in the PK assessments. Of par. who completed the study, some were not included at W12 (sample not taken or BLQ).||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
49029|NCT01332292|Primary|Change From Baseline in the Indicated Electrocardiographic (ECG) Parameters at the Indicated Time Points on Day 14 of the Respective Treatment Period|PR, QRS, QT, QTcB, QTcF, and RR were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. Change from Baseline was calculated as the value at Day 14 minus the Baseline value. QTcB is the QT duration corrected for heart rate by Bazett’s formula. QTcF is the QT duration corrected for heart rate by Fridericia’s formula.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||milliseconds (msec)||Standard Deviation|Mean
49045|NCT01332292|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||liters/minute||Standard Deviation|Mean
49030|NCT01332292|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Days 1 and 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
49031|NCT01332292|Secondary|Total Emitted Dose (TED) on Days 1 and 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||micrograms||Standard Deviation|Mean
49032|NCT01332292|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Kilopascal (kpa)||Standard Deviation|Mean
49033|NCT01332292|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
49034|NCT01332292|Secondary|Inhalation Time on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Seconds||Standard Deviation|Mean
49035|NCT01332292|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters per minute (L/min)||Standard Deviation|Mean
49136|NCT01332019|Secondary|Number of Gd-Enhancing Lesions|The number of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
49036|NCT01332292|Secondary|Oropharyngeal Volume on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||cubic centimeters (cm^3)||Standard Deviation|Mean
49037|NCT01332292|Secondary|Distance of Assessment on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of each treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters (cm)||Standard Deviation|Mean
49038|NCT01332292|Secondary|Average Oropharyngeal Cross-sectional Area on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||centimeters squared (cm^2)||Standard Deviation|Mean
49039|NCT01332292|Secondary|Serum Cortisol Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period|Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time point were analyzed.||nanomoles per Liter||95% Confidence Interval|Geometric Mean
49040|NCT01332292|Secondary|Tmax and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population. Only those participant who had quantifiable FF concentrations were analyzed.||hours||Standard Deviation|Mean
49041|NCT01332292|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
49042|NCT01332292|Secondary|AUC(0-t) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC(0-t)) curve from time zero (pre-dose) to the last time of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. Due to non-quantifiable values, it was not possible to derive AUC(0-12).|Day 14 of the respective treatment period|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzed||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
49043|NCT01332292|Primary|Heart Rate at Baseline and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Beats per minute||Standard Deviation|Mean
49044|NCT01332292|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
49137|NCT01332019|Secondary|Number of New T1 Hypointense Lesions|The total number of new T1 hypointense lesions as assessed by MRI.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
49047|NCT01332292|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
49048|NCT01332292|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
49049|NCT01332292|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
49050|NCT01332292|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.||10^12 picograms (pg) per cell||Standard Deviation|Mean
49051|NCT01332292|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed .||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
49052|NCT01332292|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.||percentage of red blood cells in blood||Standard Deviation|Mean
49053|NCT01332292|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
49054|NCT01332292|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
49055|NCT01332292|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
49056|NCT01332292|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 6)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication||participants|||Number
49057|NCT01332253|Secondary|Blood Loss During Surgery|Amount of Blood Lost During Surgery in milliliters|End of Surgery|Blood loss during surgery in milliliters||milliliters||Standard Deviation|Mean
49138|NCT01332019|Secondary|Number of New Active Lesions|The number of new active lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
49058|NCT01332253|Secondary|Parental Satisfaction With Vomiting Control in the Post-Operative Period.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to vomiting control. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 3 asked How satisfied were you with your child's vomiting management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with Vomiting Control.||participants|||Number
49059|NCT01332253|Secondary|Parent Satisfaction With Regards to Nausea Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to nausea management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 2 asked How satisfied were you with your child's nausea management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with nausea management during the study||participants|||Number
49060|NCT01332253|Secondary|Parent Satisfaction With Regards to Pain Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 1 asked How satisfied were you with your child's pain management at the time of discharge?"|Discharge|Summary of Parent Satisfaction Post-Procedure with Pain Management at the time of discharge?||participants|||Number
49061|NCT01332253|Secondary|Time to Swallow Post Procedure.|Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded.|every 15 minutes until able to swallow|||hours||Standard Error|Mean
49062|NCT01332253|Secondary|Time to Discharge Post Procedure.|To evaluate the secondary objective of pain, the time to participant discharge will be measured.|Discharge|||hours||Standard Error|Mean
49063|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 120 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|120 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 120 minutes post-procedure.||millimeters||Standard Deviation|Mean
49064|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.|"o evaluate the secondary objective of pain, the patient's self-reported pain at 90 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|90 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 90 minutes post-procedure.||millimeters||Standard Deviation|Mean
49065|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 60 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|60 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 60 minutes post-procedure.||millimeters||Standard Deviation|Mean
49066|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.|"The patient's self-reported pain at 30 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|30 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 30 minutes post-procedure.||millimeters||Standard Deviation|Mean
49067|NCT01332253|Primary|Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.|To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.|4 hours|||fentanyl doses||Standard Deviation|Mean
49068|NCT01332227|Secondary|Mean Changes in Fasting Lipid Levels From Baseline to Week 48|LD=low-density lipoprotein; HDL=high-density lipoprotein.|From Baseline to Week 48|All participants who received study drug||mg/dL||Standard Error|Mean
49069|NCT01332227|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to Week 48|All participants who received study drug||Particpants|||Number
49070|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 48|Participants with virologic rebound||Participants|||Number
49071|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 24|Patients who received study drug, who had an HIV-1 RNA measurement at the analysis week and who experienced virologic rebound.||Participants|||Number
49072|NCT01332227|Secondary|Number of Participants With Virologic Rebound at Weeks 24 and 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.|Day 1 to Weeks 28 and 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.||Participants|||Number
49073|NCT01332227|Secondary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48|Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.|From Day 1 to Week 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.||Percentage of participants||95% Confidence Interval|Number
49074|NCT01332227|Primary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24|HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.|From Day 1 to Week 24|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.||Percentage of participants||95% Confidence Interval|Number
49075|NCT01332149|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49076|NCT01332149|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49104|NCT01332071|Primary|AUC0-t of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
49077|NCT01332149|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
49078|NCT01332149|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant’s perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49079|NCT01332149|Secondary|Clinical Global Impression of Change (CGIC) at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician’s perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49080|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49081|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49082|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49083|NCT01332149|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||percentage of participants|||Number
49084|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49105|NCT01332071|Primary|AUC0-infinity of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
49085|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49086|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49087|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49088|NCT01332149|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. N=number of evaluable participants for each category||units on a scale||Standard Deviation|Mean
49089|NCT01332149|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49090|NCT01332149|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49091|NCT01332149|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
49092|NCT01332149|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9|SF-MPQ was assessed according to the participant’s answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 5, and 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. No inferential analyses were performed.||units on a scale||Standard Deviation|Mean
49093|NCT01332149|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline.|End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||percentage of participants|||Number
49094|NCT01332149|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.||units on a scale||Standard Error|Least Squares Mean
49095|NCT01332149|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
49096|NCT01332149|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
49097|NCT01332149|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.||units on a scale||Standard Error|Least Squares Mean
49098|NCT01332149|Primary|Change From Baseline in Mean Pain Score at Endpoint|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Error|Least Squares Mean
49099|NCT01332149|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
49100|NCT01332123|Secondary|Heart Rate Change|Subjects were wearing a wireless heart rate monitor. The respective readings were noted and assessed during and immediately following the trials to estimate individual exertion rates. Changes in heart rate between resting and exertion across the sample were investigated to be able to interpret the primary outcome measures and to discuss limitations of the protocol. Unequal exertion rates within the sample would cause uneven trends biomechanical changes that are related to exertion.|1 hour|||beats/minute||Full Range|Mean
49101|NCT01332123|Primary|Overall Asymmetry Index|"Gait data was continuously recorded and was post processed to determine symmetry between left and right legs. Symmetry was computed by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.~The overall asymmetry index was calculated as the mean of the following: max knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), knee moment, dorsi-flexion moment, plantar-flexion moment, times of max in % of the gait cycle, Stance phase % of gait cycle and step length.~The kinematics asymmetry index was calculated as the mean of the following: maximal knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), the times of max in % of the gait cycle, Stance phase % of gait cycle and step length.~The kinetics asymmetry index was calculated as the mean of the following variables: knee moment, dorsi-flexion moment, plantar-flexion moment, the times of max in % of the gait cycle."|1 hour|Two of the recruited participants were not included in the analysis, as they had bilateral amputations. Bilateral amputation was not posted as an exclusion criteria initially, but posted unanticipated limitations during data collection and analysis.||unit-less index (0 = perfect symmetry)||Standard Deviation|Mean
49102|NCT01332071|Primary|Cmax of Metformin Hydrochloride|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
49103|NCT01332071|Primary|AUC0-infinity of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
49107|NCT01332071|Primary|AUC0-t of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
49108|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Main reason for missed injections? answer choices were given as medication side effects, injection pain, forget to take medication, tired of taking injections, don't think medication is working, or other. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment who missed at least 1 injection at given timepoint.||participants|||Number
49109|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Over the past 4 weeks, did you miss any of your injections? answer choices were given as none missed, miss 1 injection, or miss 2 injections. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||participants|||Number
49110|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement I am satisfied with the dosing frequency (2 times per month) of this medication answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49111|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This medication improves my self-confidence and self-reliance, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49112|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing enables me to be more spontaneous and flexible, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49113|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing makes it more convenient for me to travel/vacation, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49114|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This medication makes it easy for me to carry out my daily responsibilities (ie, going to work, doing household chores or caring for my family), answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49115|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49162|NCT01331304|Secondary|Risk of Cardiovascular Disease - Framingham Risk Score|The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD).|6 months||||||
49116|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How likely would you be to continue to use this medication? answers were numerically rated from 1 (extremely unlikely) to 10 (extremely likely). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49117|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How satisfied or dissatisfied are you with the injection frequency (every 2 weeks)? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49118|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Overall, how satisfied or dissatisfied are you with this medication? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49119|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication every 2 weeks? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49120|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication as instructed? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49121|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How tolerable or intolerable do you find the medication? answers were numerically rated from 1 (extremely intolerable) to 10 (extremely tolerable). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49122|NCT01332019|Secondary|Number of MS-Related Hospitalizations|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment||hospitalizations|||Number
49123|NCT01332019|Secondary|Number of Relapses Requiring IV Steroid Use|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment||relapses|||Number
49124|NCT01332019|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49125|NCT01332019|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D) Index Score|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores of 1, 2, or 3 are possible responses for each of 5 questions (1=no problems, 2=some problems, 3=severe problems). A scoring formula developed by the EuroQol Group is then used to assign utility values for each participant’s Health State Profile. A summary index score (EQ-5D index score) is derived from the 5 questions by conversion with this scoring formula and a table of scores. EQ-5D Summary Index values ranged from -0.6 (worst health state) to 1.00 (perfect health state). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49190|NCT01331005|Secondary|Corneal Ulceration||Baseline to 12 months||||||
49191|NCT01331005|Primary|Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3||From Baseline to 12 months|||mm3||95% Confidence Interval|Mean
49126|NCT01332019|Secondary|Change From Baseline in SF-12 Physical Component Score (PCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. PCS was computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49127|NCT01332019|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. MCS computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49128|NCT01332019|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score|The 29-item MSIS-29 is a disease-specific participant-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Responses use a 5-point Likert scale ranging from 1 to 5. All questions are to be answered. The physical well being assessment portion of the MSIS-29 consists of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49129|NCT01332019|Secondary|Change From Baseline in Symbol Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 (worst) to 110 (best).|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49130|NCT01332019|Secondary|Time to Sustained Disability Progression|Estimated proportion of participants with progression and time to progression based on the Kaplan-Meier product limit method. Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from 105MS302 baseline EDSS ≥ 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from 105MS302 baseline EDSS = 0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Participants were censored at the time of withdrawal/switch/A3 effective date if they withdrew from study, switched to alternative MS medication, or Amendment 3 took effect without a progression.|Weeks 12, 24, 28, 72, 96, 120, 144, 168|Participants in the ITT population (all participants who were assigned a treatment and received at least 1 dose of study treatment) with disability progression.||proportion of participants|||Number
49131|NCT01332019|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS). The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||units on a scale||Standard Deviation|Mean
49132|NCT01332019|Secondary|Percentage Change of Whole Brain Volume|Percentage change of whole brain volume as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||percentage change||Standard Deviation|Mean
49133|NCT01332019|Secondary|Volume of Gd-Enhancing Lesions|The volume of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||cm^3||Standard Deviation|Mean
49134|NCT01332019|Secondary|Volume of T1 Hypointense Lesions|The volume of T1 hypointense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||cm^3||Standard Deviation|Mean
49192|NCT01330914|Secondary|Bone Structure|Trabecular and cortical bone microstructure by HR-pQCT|pre-operatively and 6 and 12 months post-operatively||||||
49296|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 8||Week 8|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
49139|NCT01332019|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The total number of new or newly enlarging T2 hyperintense lesions (from Study 105MS302 Baseline) as assessed by magnetic resonance imaging (MRI). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.||lesions||Standard Deviation|Mean
49140|NCT01332019|Secondary|Percentage of Participants Who Relapsed|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. New or recurrent neurologic symptoms that occur less than 30 days following the onset of a relapse were considered part of the same relapse. Participants who did not experience a relapse prior to switching to alternative MS medications, withdrew from study, or Amendment 3 (A3) took effect were censored at the time of switch/withdrawal/A3 effective date.|Up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.||percentage of participants|||Number
49141|NCT01332019|Secondary|Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of person-years followed in the period.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.||relapses per person-years|Relapses|95% Confidence Interval|Number
49142|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Urinalysis|Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low or high/positive and who had at least 1 post-baseline value.||participants|||Number
49143|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. TSH=thyroid stimulating hormone.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
49144|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Liver Function Laboratory Values|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.||participants|||Number
49145|NCT01332019|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug and at least 1 post-baseline value for given parameter.||participants|||Number
49146|NCT01332019|Primary|Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded.||participants|||Number
49147|NCT01331824|Secondary|Safety as Measured by the Frequency and Type of Adverse Events as Per the Common Terminology for Adverse Events (CTCAE) Version 4.0.||Day 1 of each treatment cycle; and 21 days after the last dose of amrubicin||||||
49148|NCT01331824|Secondary|Overall Survival|The median overall survival|1 year|||months||95% Confidence Interval|Median
49149|NCT01331824|Secondary|Progression-free Survival|"The median progression-free survival~After the last dose of Amrubicin, patients will have follow-up every 3 months with a repeat CT scan of the chest, abdomen, and pelvis until the time of disease progression is documented."|Every 3 months post Amrubicin administration|||months||95% Confidence Interval|Median
49297|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 4||Week 4|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
49150|NCT01331824|Primary|Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|"Response to treatment based on tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|6 weeks|||percentage of participants||95% Confidence Interval|Number
49151|NCT01331694|Secondary|Average Annual Adjusted Post-Index COPD-Related Costs|Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists [LABA], inhaled corticosteroids [ICS], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.|Incurred over the 12 month period after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States||United States dollars||Standard Deviation|Mean
49152|NCT01331694|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Event|The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.|Anytime from 30 days to 12 months after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States.||days||Standard Error|Mean
49153|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
49154|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
49155|NCT01331681|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||micrometer||Standard Deviation|Mean
49156|NCT01331681|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.||Percentage of participants|||Number
49157|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.||Percentage of participants|||Number
49158|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.||Percentage of participants|||Number
49159|NCT01331681|Primary|Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA.||Letters correctly read||Standard Deviation|Mean
49160|NCT01331304|Primary|Necessary Clinical Adjustments|Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations.|6 Months|||Mean NCAs per month||Standard Deviation|Mean
49161|NCT01331304|Secondary|Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships.|6 months||||||
49193|NCT01330914|Secondary|Bone Mineral Density (BMD, Areal and Volumetric)|Areal BMD at the spine, proximal femur, and forearm by dual-energy X-ray absorptiometry (DXA); volumetric BMD at the spine and hip by quantitative computed tomography (QCT); volumetric BMD at the ultradistal radius and ultradistal tibia by high-resolution peripheral QCT (HR-pQCT)|pre-operatively and 6 and 12 months post-operatively||||||
49163|NCT01331304|Primary|Clinical Global Impression-Efficacy Index (CGI-EI)|The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score.|Average 6 month score minus Average baseline score|||Units on the scale||95% Confidence Interval|Mean
49164|NCT01331291|Secondary|Anti-tumor Response|Assess anti-tumor response in patients in Arm B using MacDonald criteria. There are four possible responses: complete response, partial response, stable disease, or progressive disease. Criteria are based on measurements of tumor dimension as visualized with a contrast-enhanced MRI.|2 years|Only Arm B participants were evaluable for this outcome measure||participants|||Number
49165|NCT01331291|Secondary|Safety Profile|Overall safety profile will be characterized by type, frequency, severity (as graded by NCI CTCAE), timing and relationship of study therapy of adverse events and laboratory abnormalities. Safety and tolerability will be measured by the proportion of patients who experience Grade 3 or higher Adverse Events that are possibly, probably or definitely related to bosutinib and the number of same Adverse Events per patient. Adverse Events will be summarized by treatment for each arm by the frequency of patients experiencing treatment emergent adverse events.|2 years|||participants|||Number
49166|NCT01331291|Secondary|Intratumoral Concentration|Assess the intratumoral concentration of bosutinib in recurrent glioblastoma patients who are candidates for surgical re-resection (ARM A).|2 years|Participants in Arm B were never eligible for this outcome measure. Because only two participants were enrolled to Arm A, this analysis was not done as there were not sufficient tumor samples to generate meaningful results.|||||
49167|NCT01331291|Primary|Progression-Free Survival|Assess progression-free survival at six months in patients with recurrent glioblastoma at first or second recurrence who are treated with continuous daily dosing of bosutinib (Arm B). Progression-free survival is measured from initiation of study treatment to date of progression.|2 years|This outcome was only applicable to participants enrolled on Arm B.||weeks||95% Confidence Interval|Median
49168|NCT01331213|Secondary|Post-treatment Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
49169|NCT01331213|Secondary|Colonic Motility Index|The postprandial motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1] A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostatically-controlled balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|Approximately 1 hour after meal|||log mm Hg||Standard Deviation|Mean
49170|NCT01331213|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|Approximately 60 minutes after drug administration|||mL||Standard Deviation|Mean
49171|NCT01331213|Primary|Overall Sensory Ratings in Response to 16, 24, 30 and 36 mm Hg Distensions.|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
49172|NCT01331213|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
49173|NCT01331213|Primary|Postprandial Colonic Tone [Reported as the Symmetric Percent [Change} in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)|||Symmetric percentage change||Standard Deviation|Mean
49174|NCT01331213|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|baseline (1 hour before drug administration), post-treatment (1 hour after drug administration)|||mm Hg||Standard Deviation|Mean
49175|NCT01331161|Secondary|The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX|The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX|2 years|Participants with both T and B cell responses to vaccine||participants|||Number
49176|NCT01331161|Primary|Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX|The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX|2 years|participants with immunoglobulin gene responses that correlated with adaptive immune responses||participants|||Number
49177|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:~Preparatory acts or behavior~Aborted attempt~Interrupted attempt~Actual attempt~Completed suicide attempt"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
49178|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
49179|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
49180|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
49181|NCT01331109|Primary|Adverse Events|Number of Patients who experience one or more treatment emergent adverse event (TEAE)|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
49182|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
49183|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.||participants|||Number
49184|NCT01331005|Secondary|Change in Level of Diabetic Retinopathy on Stereoscopic Fundus Photographs|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|Baseline to 12 months||||||
49185|NCT01331005|Secondary|Change in Number of Thickened Subfields on OCT|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|Baseline to 12 months||||||
49186|NCT01331005|Secondary|Change in OCT Central Subfield Thickness|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months||||||
49187|NCT01331005|Secondary|Mean Change in Visual Acuity|The 95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for diabetic macular edema(DME) before 1 year, visual acuity and optical coherence tomography (OCT) measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months||||||
49188|NCT01331005|Secondary|Irritation||Baseline to 12 months||||||
49189|NCT01331005|Secondary|Corneal Melting||Baseline to 12 months||||||
49194|NCT01330914|Primary|Change in Intestinal Calcium Absorption|"Change in fractional calcium absorption, determined by dual stable isotope method.~Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%."|6 months|Participants from the cohort who underwent assessment of fractional calcium absorption preoperatively and 6 months postoperatively||% of ingested calcium that is absorbed||Standard Deviation|Mean
49195|NCT01330628|Primary|Freedom From Major Adverse Events (MAE)|Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).|30 days|The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis.||# of participants free from MAE|||Number
49196|NCT01330628|Primary|Freedom From Target Lesion Revascularization (TLR)|Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.|6 months|The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis.||# of participants free from TLR|||Number
49197|NCT01330433|Secondary|Hospital Stay|Number of days post surgery.|Length of stay after second surgery up to 1 month|The difference in the number of participants analyzed and the total number of participants is due to feeding issues unrelated to the surgery or the device that required the subject to remain hospitalized longer than anticipated.||days||Standard Deviation|Mean
49198|NCT01330433|Primary|Adhesion Burden|Skin to bypass time as an indicator of adhesion burden.|Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)|||minutes||Standard Deviation|Mean
49199|NCT01330433|Primary|Post-operative Bleeding|Post-operative bleeding through surgical site drainage output.|Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery|The difference in the number of participants analyzed and the total number of participants is due to the information not being properly collected at the time of the surgery. Because there was a lack of confidence in the data, it was discarded.||cm^3||Standard Deviation|Mean
49200|NCT01330433|Primary|Severity of Adhesions at the Right Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
49201|NCT01330433|Primary|Severity of Adhesions at the Left Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
49202|NCT01330433|Primary|Severity of Adhesions at the Diaphragm Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
49203|NCT01330433|Primary|Severity of Adhesions at the Arterial Base Site.|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
49204|NCT01330433|Primary|Severity of Adhesions at the Retrosternal Site|Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery|||percentage of participants|||Number
49216|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
49217|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
49298|NCT01329978|Secondary|Percentage of Participants With HCV RNA < LOD at Week 2||Week 2|Participants in the Safety Analysis Set with Available data were analyzed.||percentage of participants|||Number
49205|NCT01330420|Secondary|The Health Promoting Lifestyle Profile II (HPLP-II)|"The Health Promoting Lifestyle Profile II (HPLP-II) was used to assess health promoting behaviors. Based on the Health Promoting Model (Pender, 1982) this 52-item instrument measures self-initiated health behaviors that serve to maintain or enhance the level of self-actualization and wellness. Included are subscales for physical activity, spiritual growth, health responsibility, interpersonal relations, nutrition, and stress management. It is self-administered and uses a 4-point response format. Both English and Spanish versions are available.~A score for overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items; six subscale scores are obtained similarly by calculating a mean of the responses to subscale items. Scores range from 1 = Never to 4 = Routinely, with a higher score corresponding to a more health promoting lifestyle."|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
49206|NCT01330420|Primary|Satisfaction With Care (PSQ-18)|Patient Satisfaction Questionnaire Short Form (PSQ-18) takes approximately 3-4 minutes to complete, containing 18 items examining seven dimensions of satisfaction with medical care: general satisfaction (2 questions, Mean =3.58, SD =0.94), technical quality (3 questions, Mean = 3.68, SD = 0.76), interpersonal manner (2 questions, Mean = 4.09, SD = 0.69), communication (2 questions, Mean = 3.74, SD = 0.87), financial aspects (2 questions, Mean = 3.78, SD = 0.94), time spent with doctor (2 questions, Mean = 3.59, SD = 0.94), and accessibility and convenience (4 questions, Mean = 3.76, SD = 0.74). Responses to each item are given on a 5-point scale ranging from 1 - strongly agree to 5 - strong disagree, therefore higher scores correspond to less satisfaction. PSQ-18 subscale scores are substantially correlated with their full-scale counterparts and possess generally adequate internal consistency reliability.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
49207|NCT01330420|Primary|Quality of Life (QOL-5)|The QOL-5 is a short, global, and generic quality of life (QoL) questionnaire for clinical databases. The QOL-5 item tool is used to compare various population groups using generic factors common to people everywhere irrespective of age, sex, culture, and state of health. Scores on the QOL-5 ranges from 0 = lowest quality to 100 = highest quality.|comparison pre program initiation and post program completion time points (6 weeks)|||units on a scale||Standard Deviation|Mean
49208|NCT01330420|Primary|Health Status (SF-12)|The SF-12 was used to assess health status. It is the shortened version of the well-validated SF-36, directed at monitoring overall physical and mental health outcomes. It is available in both English and Spanish. Scoring algorithms involve weighted-item responses, all 8 scales to use the same standardization for easy comparison. All scores range from 0–100 where higher scores indicated better QOL. The mean = 50 and the SD = 10.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
49209|NCT01330420|Primary|Depression Severity (CEDS-10)|The Center for Epidemiologic Studies Depression Scale (CES-D 10) was used to assess depression severity pre-and post-intervention. This is the shorter 10-item, modified version of the 20-item CES-D. The total score is the sum of the 10 item weights, with the lowest possible score being 0 and the highest possible score being 30, and a higher score indicating more depressive symptoms. Developed from other well-validated depression scales, this instrument measures the experience of depressive symptoms over the past week. This instrument is shown to be better than the CES-D 20 in combining data from different ethnic and cultural groups, and is available in both English and Spanish. This scale has been reported to have good internal consistency and validity.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.||units on a scale||Standard Deviation|Mean
49210|NCT01330394|Secondary|Effort to Control the Urge for Use Alcohol|Obsessive Compulsive Drinking Scale will be applied before and after ERP procedures|one year and a half||||||
49211|NCT01330394|Secondary|Quality of Life|Quality of life scale will be applied at the end of the protocol|one year and a half||||||
49212|NCT01330394|Secondary|Cognitive Tasks|Cognitive tests comprised by Frontal Assessment Battery (FAB), verbal n-back task, visuospatial n-back task, go-no-go task, counting Stroop, will be done at the beginning of the session 1 and session 6 (one week after the 5 sessions of sham or tDCS).|one year and a half||||||
49213|NCT01330394|Secondary|Event-related Potentials|Event-related potential (ERPs) was recorded under the presentation of 120 sounds [60 of 3 types related to the use of alcoholic beverages (open a can of beer, fill a glass of beer, opening and fall of the lid of a bottle of beer), and 3 types of 60 neutral sounds (open a door, typing a keyboard, shower water)] lasted for 384 s for each period before and after transcranial Direct Current Stimulation|one year and a half||||||
49214|NCT01330394|Primary|Use of Alcohol|Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).|6 months after treatment|||participants|||Number
49215|NCT01330381|Secondary|Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
49299|NCT01329978|Secondary|Change in HCV RNA at Week 12||Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
49220|NCT01330381|Secondary|Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period||Baseline and over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||SBM/week||Standard Deviation|Mean
49221|NCT01330381|Secondary|Number of SBM Per Week in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||SBM/week||Standard Deviation|Mean
49222|NCT01330381|Secondary|Time to First SBM in the Double-Blind Treatment Period|After intake of the trial medication on Day 1.|Day 1 onwards|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.||hours||95% Confidence Interval|Median
49223|NCT01330381|Secondary|Number of Rescue Medications Taken in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||rescue medications/week||Standard Deviation|Mean
49224|NCT01330381|Secondary|Frequency of Toilet Training in the Double-Blind Treatment Period|Only for subjects after acquisition of toileting skills.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||toilet trainings/week||Standard Deviation|Mean
49225|NCT01330381|Secondary|Abdominal Pain Score in Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
49226|NCT01330381|Secondary|Large Diameter Stools in the Double-Blind Treatment Period|Large diameter stools make defecation more difficult. Small diameter stools are better.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||large diameter stools/week||Standard Deviation|Mean
49227|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period|Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
49228|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period|Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
49229|NCT01330381|Secondary|Painful Bowel Movements Score in the Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||units on a scale||Standard Deviation|Mean
49230|NCT01330381|Secondary|Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period|Purposefully avoiding defecation.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||retentions/week||Standard Deviation|Mean
49231|NCT01330381|Secondary|Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period|Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.||percentage of subjects|||Number
49232|NCT01330381|Secondary|Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.||percentage of subjects|||Number
49233|NCT01330381|Primary|Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period|Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.||percentage of subjects|||Number
49234|NCT01330355|Secondary|Microbial Outcome|"Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:~over all bacterial species~over all and individual gram-positive bacterial species~over all and individual gram-negative bacterial species"|Visit 3 (Day 3) and Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species).||events|||Number
49235|NCT01330355|Secondary|Microbial Eradication|Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.||participants|||Number
49238|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure Bilirubin total is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||milligram (mg)/dL||Standard Deviation|Mean
49239|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [AST]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure AST is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||U/L||Standard Deviation|Mean
49240|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [ALT]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure ALT is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||Units (U)/Litre (L)||Standard Deviation|Mean
49241|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure Haemoglobin is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS||gram (g)/decilitre (dL)||Standard Deviation|Mean
49242|NCT01330316|Secondary|Laboratory Test Abnormalities by DAIDS Grades|This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.|baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study|FAS||percentage of participants|||Number
49243|NCT01330316|Secondary|Occurrence of Drug-related AEs as Assessed by the Investigator|This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
49244|NCT01330316|Secondary|Occurrence of Serious Adverse Events (SAEs)|This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
49245|NCT01330316|Secondary|Occurrence of Adverse Events Leading to Treatment Discontinuation|This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
49246|NCT01330316|Secondary|Occurrence of Adverse Events (Overall and by DAIDS Grade)|"This outcome measure will be presented as the percentage of subjects with any adverse event (AE).~Percentages are calculated using total number of subjects per treatment cohort as the denominator.~The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment."|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS||percentage of participants|||Number
49247|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS||participants|||Number
49248|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.|FAS||participants|||Number
49249|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS|FAS||participants|||Number
49250|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS||participants|||Number
49251|NCT01330316|Secondary|Early Treatment Success (ETS)|ETS, defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|FAS||percentage of participants|||Number
49252|NCT01330316|Secondary|Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS||percentage of participants||95% Confidence Interval|Number
49253|NCT01330316|Primary|Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL|The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS||percentage of participants||95% Confidence Interval|Number
49254|NCT01330303|Primary|Cmax|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
49255|NCT01330303|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study||ng.h/ml||Standard Deviation|Mean
49256|NCT01330303|Primary|AUC 0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
49257|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49258|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49259|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49260|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49261|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49262|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49263|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49264|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49265|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49266|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49300|NCT01329978|Secondary|Change in HCV RNA at Week 8||Baseline (Day 1) to Week 8|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
49267|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49268|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49269|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49270|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49271|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49272|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49301|NCT01329978|Secondary|Change in HCV RNA at Week 4||Baseline (Day 1) to Week 4|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
49273|NCT01330290|Secondary|Score for the Physicians’ Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49274|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.||participants|||Number
49275|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.||participants|||Number
49276|NCT01330290|Primary|Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49277|NCT01330290|Primary|Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.||units on a scale|Participants|Standard Deviation|Mean
49278|NCT01330108|Secondary|Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan|Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was.|baseline to 12 weeks|||meters||Full Range|Mean
49279|NCT01330108|Primary|Number of Subjects Not Able to Tolerate Ambrisentan|If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject.|baseline to 12 weeks|||participants|||Number
49280|NCT01330030|Primary|Expired-air Carbon Monoxide Confirmed Smoking Abstinence|expired-air carbon monoxide confirmed smoking abstinence at 52 weeks|52 weeks|intention to treat||participants not smoking|||Number
49281|NCT01330017|Secondary|Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7|The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline, Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
49302|NCT01329978|Secondary|Change in HCV RNA at Week 2||Baseline (Day 1) to Week 2|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
49282|NCT01330017|Secondary|Time to Maximal Effect|Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.|Baseline up to Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Days|||Number
49283|NCT01330017|Secondary|Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the~morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
49284|NCT01330017|Secondary|Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
49285|NCT01330017|Secondary|Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the~morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Day 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
49286|NCT01330017|Secondary|Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
49287|NCT01330017|Secondary|Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
49288|NCT01330017|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.|Baseline, Day 7|The Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study medication.||Units on a Scale||Standard Deviation|Mean
49289|NCT01329978|Secondary|Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).|Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.|End of treatment to Post-treatment Week 24|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
49290|NCT01329978|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either~HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or~HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)~Baseline was Day 1 for all groups."|Baseline (Day 1) to Week 24|Safety Analysis Set||percentage of participants|||Number
49291|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Post-treatment Week 4|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.|Baseline (Day 1) to Post-treatment Week 4|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.||percentage of participants|||Number
49292|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 24|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.|Baseline (Day 1) to Week 24|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.||percentage of participants|||Number
49418|NCT01328756|Primary|Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||beats per minute||Standard Deviation|Mean
49303|NCT01329978|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.|Post-treatment Week 12|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants||95% Confidence Interval|Number
49304|NCT01329978|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline (Day 1) to post-treatment Day 30|Safety Analysis Set||percentage of participants|||Number
49305|NCT01329978|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)|SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Week 24|Participants in the Safety Analysis Set (participants who were randomized and received at least 1 dose of study drug) with genotype 1 and who had available data were analyzed.||percentage of participants||95% Confidence Interval|Number
49306|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio|The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.||pg/mg||95% Confidence Interval|Mean
49307|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels|Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.||mg/mL||95% Confidence Interval|Mean
49308|NCT01329939|Secondary|Beclomethasone Equivalents|The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||micrograms||95% Confidence Interval|Mean
49309|NCT01329939|Secondary|Exhaled Nitric Oxide Measurement|A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||ppb||95% Confidence Interval|Mean
49310|NCT01329939|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.||pg/mL||95% Confidence Interval|Mean
49311|NCT01329939|Secondary|Serum Leptin Levels|Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage.|24 weeks|||ng/mL||95% Confidence Interval|Mean
49312|NCT01329939|Secondary|Spirometric Measures|Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||percent predicted||95% Confidence Interval|Mean
49313|NCT01329939|Primary|Asthma Control Test (ACT) Scores|The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|||units on a scale||95% Confidence Interval|Mean
49314|NCT01329848|Secondary|Conlon Symptom Survey|Measures visual discomfort symptoms while doing near work. 23 item survey using a 4-point rating scale (never, occasionally, often, almost always). Total raw score reported on a range from 0 to 69 with higher scores indicating more frequent symptoms.|3 weeks|||units on a scale||Standard Deviation|Mean
49315|NCT01329848|Primary|Accommodation Lag 5D|Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.|3 week period|||diopters||Standard Deviation|Mean
49316|NCT01329679|Secondary|Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
49317|NCT01329679|Secondary|Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
49318|NCT01329679|Secondary|Max QRS Duration After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
49319|NCT01329679|Secondary|Max PR-interval After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption|||msec||Standard Deviation|Mean
49320|NCT01329679|Secondary|Max Heart Rate After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption|||beats per minute||Standard Deviation|Mean
49321|NCT01329679|Secondary|Office DBP After a Single Energy Shot and After Chronic Consumption|Office diastolic blood pressure (DBP)|At baseline and 7 days post energy drink and placebo consumption|||mmHg||Standard Deviation|Mean
49323|NCT01329562|Secondary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders|"Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From mid luteal phase and for the duration of 1 menstrual migraine until headache free.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
49324|NCT01329562|Secondary|α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline from 24 hours post migraine gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||U/L||Standard Deviation|Mean
49325|NCT01329562|Secondary|CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline to 24 hours post headache gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pmol/mg||Standard Deviation|Mean
49326|NCT01329562|Secondary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria."|From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
49327|NCT01329562|Primary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.|"Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point."|From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
49328|NCT01329562|Primary|α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.||U/L||Standard Deviation|Mean
49329|NCT01329562|Primary|CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.||pmol/mg||Standard Deviation|Mean
49330|NCT01329562|Primary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache.|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.||pg/mL||Standard Deviation|Mean
49331|NCT01329562|Secondary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||U/L||Standard Deviation|Mean
49332|NCT01329562|Secondary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pmol/mg||Standard Deviation|Mean
49333|NCT01329562|Secondary|Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
49334|NCT01329562|Secondary|Time to Pain-Free in Responders vs Non-Responders|"Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.~0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine headache until pain-free.|||hours||Standard Deviation|Mean
49335|NCT01329562|Secondary|Migraine Recurrence Responders vs Non-Responders|"Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.~0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine until 24 hours post treatment.|||participants|||Number
49336|NCT01329562|Primary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||U/L||Standard Deviation|Mean
49337|NCT01329562|Primary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pmol/mg||Standard Deviation|Mean
49338|NCT01329562|Primary|Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.||pg/mL||Standard Deviation|Mean
49339|NCT01329562|Primary|Time to Pain Free|"Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe."|From onset of 1 menstrual migraine headache until pain free.|In Group B, one subject did not report when their headache resolve, therefore a duration for this subject could not be calculated.||hours||Standard Deviation|Mean
49340|NCT01329562|Primary|Migraine Recurrence|"Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe."|From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.|||participants|||Number
49341|NCT01329549|Secondary|Apparent Volume of Distribution at Steady State (Vss)|"Vss was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
49342|NCT01329549|Secondary|Total Plasma Clearance (CL)|"CL was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
49343|NCT01329549|Secondary|Terminal Half-life (t1/2)|"t1/2 was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
49344|NCT01329549|Secondary|Time From Dosing to the Maximum Plasma Concentration (Tmax)|"tmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
49345|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
49346|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)|"AUC0-tz was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
49347|NCT01329549|Secondary|Maximum Measured Plasma Concentration (Cmax)|"Cmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). This endpoint has not been statistically analyzed in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set|||||
49348|NCT01329549|Primary|Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib|to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.|28 days|Treated set|||||
49349|NCT01329419|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|12 weeks|ITT Population||participants|||Number
49350|NCT01329419|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|12 weeks|ITT Population||participants|||Number
49351|NCT01329419|Primary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|12 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments||participants|||Number
49352|NCT01329263|Primary|Subjective Rating of Cigarettes|Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.|Immediately after a cigarette smoked at the study session|Completed measure||units on a scale||Standard Error|Mean
49353|NCT01329263|Primary|Nicotine Levels|Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.|35 days|Those completing Day 5, returning sample for assay||micrograms/mL||Standard Error|Mean
49354|NCT01329263|Primary|Smoking Topography- Carbon Monoxide Boost|Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.|Measured before and after each cigarette smoked at study sessions|||parts per million||Standard Error|Mean
49355|NCT01329263|Primary|Smoking Topography- Puff Volume|The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.|over 35 day study period|Those completing Study session 2 at Day 5.||mL||Standard Error|Mean
49356|NCT01329198|Secondary|Correlation of Tics and Neural Physiology|Electrical recordings of electroencephalography activity were taken from each subject's implanted leads at each visit from baseline to 6 months. At baseline, the recordings were taken with the device in the off state (not stimulating), while at the 6 month visits the recordings were taken with the subject's device set to optimal parameters for tic control. Using Pearson's correlation coefficient, the variations in frequency and power which were observed were correlated with the Yale Global Tic Severity (YGTSS) scores obtained during primary outcome testing.|Baseline to 6 Months|||Pearson Correlation Coefficient|||Number
49357|NCT01329198|Primary|Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented|"The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are:~Total Motor Tic Score (0-25)~Total Phonic Tic Score (0-25~Total Tic Score (0-50)~Overall Impairment Rating (0-50)~Global Severity Score (0-7)~The YGTSS Total Score is obtained by adding the Total Tic Score to the Overall Impairment Rating. The efficacy of the intervention will be assessed by comparing each subject's 6-month YGTSS Total Score to the pre-operative value for the same patient. Efficacy is considered 50% or greater reduction in this score."|Baseline to 6 Months|||units on a scale||95% Confidence Interval|Mean
49358|NCT01329185|Primary|Incidence of EBV or CMV Related Disease in Transplant Recipient|Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.|At least 1 year|||participants|||Number
49359|NCT01329029|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF.|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.||kg/m^2||Standard Error|Least Squares Mean
49360|NCT01329029|Secondary|Change From Baseline in Body Weight|Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF).|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.||kilogram (kg)||Standard Error|Least Squares Mean
49361|NCT01329029|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|52 Weeks|Safety Population included all randomized participants who received at least one dose of study drug.||percentage of participants|||Number
49419|NCT01328756|Primary|Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)|BMI was calculated as (weight [kilogram] per height [square meter]).|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||kilogram per square meter||Standard Deviation|Mean
49362|NCT01329029|Secondary|Time to Trial Withdrawal Due to an Adverse Event|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.||days||Full Range|Median
49363|NCT01329029|Secondary|Time to First Hospitalisation Due to Any Cause During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.||days||95% Confidence Interval|Median
49364|NCT01329029|Secondary|Percentage of Participant With All-Cause Hospitalisation During the Treatment Period|Percentage of patients with at least one hospital admission due to any cause.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
49365|NCT01329029|Secondary|Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
49366|NCT01329029|Secondary|Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke).|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
49367|NCT01329029|Secondary|Time to Withdrawal Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
49368|NCT01329029|Secondary|Time to Withdrawal During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
49369|NCT01329029|Secondary|Time to Mortality Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
49370|NCT01329029|Secondary|Time to Mortality Due to Any Reason During the Treatment Period Score|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
49371|NCT01329029|Secondary|Percentage of Participants With Improvement in CAT|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
49372|NCT01329029|Secondary|Change From Baseline in COPD Assessment Test (CAT) Total Score|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||score on a scale||Standard Error|Mean
49373|NCT01329029|Secondary|Percentage of Rescue Medication-Free Days|Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of days||Standard Deviation|Mean
49374|NCT01329029|Secondary|Percentage of Symptom-Free Days|Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of days||Standard Deviation|Mean
49420|NCT01328756|Primary|Change From Baseline in Height at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||centimeter(s)||Standard Deviation|Mean
49375|NCT01329029|Secondary|Change From Baseline in COPD Symptom Score From Daily Diary|Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome).|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
49376|NCT01329029|Secondary|Change From Baseline in Use of Rescue Medication From Daily Diary|Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data included in the repeated measurements analysis.||puffs per day||Standard Error|Least Squares Mean
49377|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator FEV1/FVC|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percent||Standard Deviation|Mean
49378|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters||Standard Error|Least Squares Mean
49379|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%)|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters/second||Standard Error|Least Squares Mean
49380|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters||Standard Error|Least Squares Mean
49381|NCT01329029|Secondary|Duration of Moderate or Severe COPD Exacerbations Per Participant|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. n in each of the categories is the number of participants with exacerbations.||days||Standard Deviation|Mean
49382|NCT01329029|Secondary|Number of Moderate or Severe COPD Exacerbation Days|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation — start date of exacerbation + 1) of all exacerbations within the category.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||days||Standard Deviation|Mean
49383|NCT01329029|Secondary|Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year|The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)— Rate (Roflumilast 500 μg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||participants|||Number
49384|NCT01329029|Secondary|Time to Third Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||Full Range|Median
49385|NCT01329029|Secondary|Time to Second Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||95% Confidence Interval|Median
49386|NCT01329029|Secondary|Time to First COPD Exacerbation All Categories|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.||days||95% Confidence Interval|Median
49387|NCT01329029|Secondary|Percentage of Participants Experiencing at Least 1 COPD Exacerbation|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||percentage of participants|||Number
49388|NCT01329029|Secondary|Rate of COPD Exacerbations Per Patient Per Year All Categories|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
49389|NCT01329029|Secondary|Rate of Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
49390|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1)|Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||liters||Standard Error|Least Squares Mean
49391|NCT01329029|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
49392|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||United States dollars||Standard Deviation|Mean
49393|NCT01328964|Secondary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||Asthma related events per100 person year|||Number
49394|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||United States dollars||Standard Deviation|Mean
49395|NCT01328964|Primary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.||asthma events per 100 person years|||Number
49396|NCT01328951|Secondary|Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants||95% Confidence Interval|Number
49397|NCT01328951|Secondary|Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants||95% Confidence Interval|Number
49398|NCT01328951|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants||95% Confidence Interval|Number
49399|NCT01328951|Secondary|Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.|At 6 months|ITT Population.||percentage of participants||95% Confidence Interval|Number
49400|NCT01328951|Secondary|Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||weeks||95% Confidence Interval|Median
49401|NCT01328951|Secondary|Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment|Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.||percentage of participants|||Number
49402|NCT01328951|Primary|Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.|At 1 year|ITT Population.||percentage of participants||95% Confidence Interval|Number
49421|NCT01328756|Primary|Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||kilogram(s)||Standard Deviation|Mean
49403|NCT01328951|Primary|Overall Survival (OS) as Median Time to Event During the Overall Study|Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.||months||95% Confidence Interval|Median
49404|NCT01328951|Primary|Percentage of Participants Who Died During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.||percentage of participants|||Number
49405|NCT01328782|Secondary|Need for IV Morphine of Fentanyl|Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.|First 120 minutes after the end of surgery (surgery close time)|All subjects were included in the analysis.||participants|||Number
49406|NCT01328782|Secondary|Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge||Analgesic data collected during first four hours following the end of surgery (surgery close)|All subjects were included in the analysis.||Morphine (po) equivalents [mg*kg-1]||Standard Deviation|Mean
49407|NCT01328782|Secondary|Time (in Minutes) to First Narcotic Administration||first 72 hours after surgery close time|All subjects were included in the analysis.||Minutes||Inter-Quartile Range|Median
49408|NCT01328782|Secondary|Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child’s Current Level of Pain, Question # 17: Child’s Worst Level of Pain When Moving Around After Surgery and Question # 18: Child’s Worst Level of Pain While Resting|Total quality pain management survey is validated survey used to assess parents’ perceptions of their child’s pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain.|Will be obtained from parent(s) 120 minutes after arrival to the recovery room|Based on number of participants and their parents/legal guardians that completed the survey.||Scores on a scale||Standard Deviation|Mean
49409|NCT01328782|Primary|The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).|The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.|Will be obtained 30 - 60 minutes after arrival to the recovery room|Based on the number of participants that self-reported their pain score.||Scores on a scale||Standard Deviation|Mean
49410|NCT01328769|Secondary|Change in Endothelial Function|Endothelial function was calculated by software from the manufacturer VENDYS. The measurement was taken by using the index of area under the curve of the finger temperature recovery curve just after releasing a blood pressure cuff. The blood pressure cuff occluded blood flow for 5 minutes as compared to the temperature curve in the non-occluded arm.|Baseline to 6 weeks|||ratio of finger temperature||Standard Deviation|Mean
49411|NCT01328769|Primary|Change in Renal Plasma Flow in Response to Infused Angiotensin II||Baseline to 6 weeks|||ml/minute||Standard Error|Mean
49412|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.|LOTA (Week 104)|FAS population||participants|||Number
49413|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.|LOTA (Week 104)|FAS population||participants|||Number
49414|NCT01328756|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)|ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.|Baseline (Week 0), LOTA (Week 104)|Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.||Scores on a scale||Standard Deviation|Mean
49415|NCT01328756|Primary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)|The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||scores on a scale||Standard Deviation|Mean
49416|NCT01328756|Primary|Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||milliseconds||Standard Deviation|Mean
49417|NCT01328756|Primary|Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome||milliseconds||Standard Deviation|Mean
49425|NCT01328756|Primary|Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant’s first dose of investigational product in this study and the 3 days following cessation of treatment.|Baseline up to 3 days after the last dose of study treatment (up to 2 years)|Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.||participants|||Number
49426|NCT01328717|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)|Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.|1 hour|Per protocol||Number of Participants|||Number
49427|NCT01328717|Primary|Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results.|1 hour|As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, one subject did not complete the study. The remaining 77 subjects tested 2 test strip lots on the system. 2x77(154) test results were available.||Percentage of BG test results|Participants||Number
49428|NCT01328574|Secondary|Incidence of TRC-105-Related Adverse Events|Adverse events by grade, (e.g. 1 is mild, 2 is moderate, 3 is severe and 4 is life threatening) related to TRC-105.|24 months|||participants|||Number
49429|NCT01328574|Secondary|Median Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 25 months|||Months||95% Confidence Interval|Median
49430|NCT01328574|Secondary|Objective Response|Objective response is defined as the number of participants who meet the criteria for a complete response (CR) or a partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 25 months|||participants|||Number
49431|NCT01328574|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|24 months|||participants|||Number
49432|NCT01328574|Primary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression).-|after 6 months on study|||Months||95% Confidence Interval|Median
49433|NCT01328444|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49434|NCT01328444|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49982|NCT01321749|Primary|Plasma Biomarkers of Coagulation and Fibrinolysis|blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer|the time points of baseline and 1, 15 and 30 days after BLIPC treatment||||||
49435|NCT01328444|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49436|NCT01328444|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49437|NCT01328444|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49438|NCT01328444|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Seconds||Standard Error|Least Squares Mean
49439|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|12 months post enrollment||||||
49440|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|3 months post enrollment||||||
49441|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|12 months post enrollment||||||
49983|NCT01321749|Primary|Blood Pressure and Heart Rates;||at the time points of baseline and 1, 15 and 30 days after BLIPC treatment||||||
49442|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|1 month post enrollment||||||
49443|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|1 month post enrollment||||||
49444|NCT01328431|Primary|Self-report of Tobacco Abstinence or Reduction|Questionnaires to assess self reported tobacco abstinence|3 months|This is the # of participants in each group.||participants|||Number
49445|NCT01328431|Primary|Biochemical Verification of Tobacco Abstinence|Biochemical verification means a breathalyzer reading for carbon monoxide.|3 months after enrollment|This is the # of participants in each group.||participants|||Number
49446|NCT01328405|Secondary|Airway Pathology|The patient will be called 24 hours later by the data collector who will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative Day Two|||participants|||Number
49447|NCT01328405|Secondary|Airway Pathology|In the recovery area, once the patient is fully awake, as judged by the recovery staff, an observer will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative (day 1) in recovery room|||participants|||Number
49448|NCT01328405|Secondary|Glottic View|Once the LMA has been placed and secured and the patient is stable from an anesthetic point of view, a flexible fiberoptic camera will be place into the airway tube of the LMA and the view of the patient's vocal cords in relation to the cuff of the LMA will be assessed.|Intraoperative (day 1)|||participants with grade 1 glottic view|||Number
49449|NCT01328405|Secondary|Grossly Visible Blood or Bile on LMA|At the conclusion of the case, when the patient is breathing on their own and is awake enough, as judged by the anesthesia provider, the LMA will be removed, as would be otherwise done as standard of care. The study LMA will be examined by a data collector for the presence of grossly visible blood or bile, and its presence or absence will be recorded.|Upon LMA removal|||participants|||Number
49450|NCT01328405|Primary|Airway Seal Pressure|The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.|Intraoperative (day 1)|||cmH2O||Standard Deviation|Mean
49451|NCT01328379|Secondary|Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.|The EQ-5D is a brief questionnaire that asks patients to rate general state of health. The VAS score rates the general state of health of a patient with 100 for the best imaginable health state and 0 for the worst imaginable health state.|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population. The number of participants analyzed corresponds with number of subjects who completed the questionnaire in each treatment group.||units on a scale||Standard Error|Mean
49452|NCT01328379|Secondary|Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3.|"Patients completed a brief, generic health status questionnaire: The five specific dimensional scores value patients’ health related to mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each question has 3 distinguishable choices that can be analyzed using a 3-point scale (i.e. 1 = no problem, 2=some problems and 3= extreme problems).~A response of 1 indicates that the patient has no problem with the dimension tested and a response of 3 indicates that the patient has extreme problems with the dimension tested. For each visit, the average score of 5 dimensions was calculated by averaging the scores of 5 dimensions. EQ-5D final score ranges from 1-3."|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population||units on a scale||Standard Error|Mean
49453|NCT01328379|Secondary|Change From Baseline in Six-Minute Walk Distance at Visit 2|The Six-Minute Walk, a test of endurance, measures the distance that a patient can walk in a period of 6 minutes. Six-minute walk distance will be reported in feet.|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population||Feet||Standard Error|Mean
49454|NCT01328379|Secondary|Change From Baseline in MSWS-12 at Visit 2|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.~For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.~MSWS-12 Score = 100 * [(Sum of Items 1-12) – 12]/48"|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population||scores on a scale||Standard Error|Mean
49455|NCT01328379|Secondary|Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.~For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.~MSWS-12 Score = 100 * [(Sum of Items 1-12) – 12]/48"|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population||scores on a scale||Standard Error|Mean
49475|NCT01328184|Secondary|Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of levonorgestrel in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
49456|NCT01328379|Secondary|Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient’s physical disability.~A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient’s foot crosses the tape. Timing will end when any part of the patient’s foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population||feet per second||Standard Error|Mean
49457|NCT01328379|Primary|Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient’s physical disability.~A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient’s foot crosses the tape. Timing will end when any part of the patient’s foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population (FAP): All randomized patients who took at least one dose of double-blind investigational medication and who have a baseline Timed 25 Foot Walk (T25FW) assessment and at least one post-baseline T25FW assessment.||feet per second||Standard Error|Mean
49458|NCT01328366|Secondary|International Index of Erectile Function Score|The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male’s erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Male participants who completed the IIEF questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
49459|NCT01328366|Secondary|Mean Change in Female Sexual Function Index (FSFI) Score From Baseline|The Female Sexual Function Index was a participant-reported questionnaire used to measure a female’s sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation.|4 week, 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
49460|NCT01328366|Secondary|Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female’s sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation.|Baseline; 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
49461|NCT01328366|Secondary|Change in 12-item Short Form Survey (SF-12) Score From Baseline|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
49462|NCT01328366|Secondary|12-item Short Form Survey (SF-12) Score|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
49463|NCT01328366|Secondary|Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant’s satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
49464|NCT01328366|Secondary|Cutaneous Body Image Scale (CBI) Scores|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant’s satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
49476|NCT01328184|Secondary|Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of ethinylestradiol in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
49465|NCT01328366|Secondary|Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.||units on a scale||95% Confidence Interval|Mean
49466|NCT01328366|Secondary|Hospital Anxiety and Depression Scale (HADS) Scores|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.||units on a scale||Standard Deviation|Mean
49467|NCT01328366|Secondary|Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
49468|NCT01328366|Secondary|Psoriasis Area and Severity Index (PASI) Scores|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
49469|NCT01328366|Secondary|Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months after adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
49470|NCT01328366|Secondary|Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
49471|NCT01328366|Primary|Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline|The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant’s QOL. “Responders” to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.||units on a scale||95% Confidence Interval|Mean
49472|NCT01328366|Primary|Dermatology Life Quality Index (DLQI) Scores|The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant’s QOL. Data are reported as the mean DLQI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.||units on a scale||Standard Deviation|Mean
49473|NCT01328184|Secondary|Assessment of Tolerability|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.|Within Day 24 to Day 31|Treated set (TS) included all subjects who took at least one dose of study medication.||percentage of participants|||Number
49474|NCT01328184|Secondary|Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.|Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.|Day 1 to day 17|Treated set (TS) included all subjects who took at least one dose of study medication.||participants|||Number
50013|NCT01320735|Primary|Number of Participants Who Switched to IAD Regimen by Visit|The data are reported as number of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Participants|||Number
49477|NCT01328184|Secondary|Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||1/h||Geometric Coefficient of Variation|Geometric Mean
49478|NCT01328184|Secondary|Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||1/h||Geometric Coefficient of Variation|Geometric Mean
49479|NCT01328184|Secondary|Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
49480|NCT01328184|Secondary|Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Geometric Coefficient of Variation|Geometric Mean
49481|NCT01328184|Secondary|Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||L||Geometric Coefficient of Variation|Geometric Mean
49482|NCT01328184|Secondary|Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||L||Geometric Coefficient of Variation|Geometric Mean
49483|NCT01328184|Secondary|Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of levonorgestrel in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||mL/min||Geometric Coefficient of Variation|Geometric Mean
49484|NCT01328184|Secondary|Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||mL/min||Geometric Coefficient of Variation|Geometric Mean
49485|NCT01328184|Secondary|Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Full Range|Median
49486|NCT01328184|Secondary|Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||hours(h)||Full Range|Median
49487|NCT01328184|Primary|Levonorgestrel: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
49488|NCT01328184|Primary|Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
49489|NCT01328184|Primary|Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
49490|NCT01328184|Primary|Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
49491|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.||percentage of participants|||Number
49492|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.||percentage of participants|||Number
49493|NCT01328158|Secondary|Number of Participants in Each CDC Classification Category of HIV-infection Over Time|CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.|Up to Month 60 after first dose of Lopinavir/Ritonavir|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49494|NCT01328158|Secondary|Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.||Log10 copies/mL||Standard Deviation|Mean
49495|NCT01328158|Secondary|Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.||Log10 copies/mL||Standard Deviation|Mean
49496|NCT01328158|Secondary|Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.||cells/mm^3||Standard Deviation|Mean
49497|NCT01328158|Secondary|Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.||cells/mm^3||Standard Deviation|Mean
49498|NCT01328158|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49499|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49500|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”. Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49513|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|||participants|||Number
49501|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49502|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49503|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49504|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49505|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49506|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49507|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49508|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49509|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49510|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49511|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49512|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49514|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49515|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49516|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49517|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49518|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49519|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49520|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All female participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49521|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||participants|||Number
49522|NCT01328158|Primary|Number of Adverse Drug Reactions|Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period..||number of adverse drug reaction|||Number
49523|NCT01328158|Primary|Percentage of Participants With Adverse Drug Reactions|Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.||percentage of participants|||Number
49524|NCT01328080|Primary|Percentage Change in Total AKN Lesions From Baseline to Week 16.|To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.|Baseline to Week 16|||percentage of lesion count reduction||Full Range|Mean
49525|NCT01328054|Secondary|Median Time to Cmax (Tmax) and the Time Prior to the First Quantifiable (Non-zero) Lapatinib Plasma Concentration (Tlag) Following the Last (3rd) Lapatinib Dose|For each participant, the time at which Cmax was observed (tmax) was determined directly from the raw concentration-time data. For each participant, the time prior to the first quantifiable (non-zero) concentration (tlag) was determined directly from the raw concentration-time data. Since all participants received 2 doses of study medication prior to the collection of the first (pre-dose) blood sample on Day 4, tlag was expected to be zero. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population||Hours||Full Range|Median
49526|NCT01328054|Secondary|Mean Maximum Plasma Concentration (Cmax) and Observed Plasma Concentration at 24 Hours Post-dose (C24) of Lapatinib|The first occurrence of Cmax and C24 was determined directly from the raw concentration-time data. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
49527|NCT01328054|Secondary|Mean Area Under the Plasma Drug Concentration-time Curve (AUC) From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC[0-t]) and From Time Zero (Pre-dose) to 24 Hours Post Dose (AUC[0-24]) for Lapatinib|AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-t) and AUC(0-24) were determined from the plasma concentration-time data using the linear trapezoidal rule for increased concentrations and the logarithmic trapezoidal rule for decreased concentrations. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose)|Pharmacokinetic (PK) Population: all participants in the ATS Population for whom at least one PK sample was obtained and analyzed. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
49528|NCT01328054|Secondary|Number of Participants With 12-lead ECG Findings at Indicated Time Points|The number of participants with the 12-lead ECG findings normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Baseline; on Day 1 (at pre-dose); on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-last- dose); on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-last-dose); at the End of Study visit (Day 8-11); and at the post-treatment Follow-up visit (if applicable).|BL;Day 1 (at pre-dose);Day 2 (at pre-dose, 4, 8, 12 and 24 hr post dose);Day 4 (at pre-dose, 4, 8, 12 and 24 hr post dose);End of Study visit (Day 8-11); and Follow-up (within approx 28 days following last dose of study trt [up to end of Study Week 4])|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Participants|||Number
49529|NCT01328054|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate were measured at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Beats per minute||Standard Deviation|Mean
49530|NCT01328054|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Blood pressure measurements included SBP and DBP and were obtained at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose). Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-dose)|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Millimeter of mercury (mmHg)||Standard Deviation|Mean
49531|NCT01328054|Secondary|Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points|Blood samples were collected for the measurement of total neutrophils (ANC), platelets, and leukocyte count at Baseline; Days 5 and 8-11. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
49532|NCT01328054|Secondary|Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points|Blood samples were collected for the measurement of calcium, chloride, CO2, potassium, sodium, magnesium and urea at Baseline; at Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
49533|NCT01328054|Secondary|Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at Baseline; Days 5 and 8-11; Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
49534|NCT01328054|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALP, ALT, and AST at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
49535|NCT01328054|Secondary|Mean Albumin, and Hemoglobin at the Indicated Time Points|Blood samples were collected for the measurement of albumin and hemoglobin at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
49536|NCT01328054|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, or is an important medical eventsthat jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, new primary cancers, liver events, cardiac dysfunction, pneumonitis, and laboratory abnormalities.|From the start of study treatment until follow-up (within approximately 28 days following the last dose of study medication [up to end of Study Week 4])|ATS Population||Participants|||Number
49537|NCT01328054|Secondary|Number of Participants With the Worst-case Post-Baseline 12-lead Holter ECG Findings With Significant ST, T Wave, and U Wave Abnormalities|Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate Holter ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. The number of participants with the worst-case post-Baseline 12-lead Holter ECG findings with significant ST, T wave, and U wave abnormalities were analyzed.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Pharmacodynamic (PD) Population: all participants from the All Treated Subjects Population (ATS) who completed the ECG acquisition via Holter monitoring of at least one time point on Days 1, 2, 3 and 4.||Participants|||Number
49538|NCT01328054|Secondary|Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points|The number of participants with 12-lead Holter ECG findings of normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate 12-lead Holter ECGs were collected at -30, -15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10,12, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and on Day 3 for lapatinib.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.||Participants|||Number
49539|NCT01328054|Secondary|Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points|A Holter monitor is an ambulatory portable device for continuously monitoring the cardiovascular system. Change from Baseline in QT interval, QTc interval, QTcB interval, QTcI interval, RR interval, PR interval, and QRS duration at each time point for lapatinib was assessed in comparison with time-matched placebo. Three replicate ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 and 3 and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the average of the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. Change from Baseline was calculated by subtracting the Baseline values from individual post-Baseline values for each time point.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.||Milliseconds||Standard Deviation|Mean
49540|NCT01328054|Primary|Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg|A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and on Day 3 for LAP. Mean change from BL was calculated by subtracting the BL values from individual QTcF for each TP. BL adjusted mean difference in absolute QTcF between LAB and PBO (trt difference) with the corresponding 90% confidence interval (CI) was estimated for each TP (pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, and 24-hr post-dose). Trt difference analysis was performed by a repeated measures analysis of variance adjusted for trt group, TP, and trt group*TP interaction.|Baseline (BL) (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours (hr) post-dose on Day 2 for placebo (PBO). Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib (LAP).|Evaluable Population: all participants in the All-Treated Subjects (ATS) Population who met the criteria for dosing compliance, ECG acquisition, and Baseline ECG acquisition. The ATS Population is comprised of all participants who received at least one dose of study medication (placebo or lapatinib).||Milliseconds||Standard Error|Least Squares Mean
49819|NCT01324271|Secondary|Number of Retained (TTDS-placed) Tubes|Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.|14 days|Total in-office (IO) subjects.||tubes|Participants||Number
49541|NCT01328041|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Phenotypic Resistance Populations. Only participants with Baseline DTG IC50 with PDVF who had paired Baseline and time of virological failure samples were considered for analysis.||Participants|||Number
49542|NCT01328041|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Genotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF. Only participants with Baseline IN mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.||participants|||Number
49543|NCT01328041|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.|Day 8, Week 4, and Week 24|Pharmacokinetic (PK) Parameter Population: all participants who received DTG, underwent PK sampling during the study, and provided an evaluable estimate of C0. Only participants with data available at the indicated time points were considered for analysis.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
49544|NCT01328041|Secondary|AUC(0-tau) and AUC(0-24) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||µg*hour/mL||95% Confidence Interval|Geometric Mean
49545|NCT01328041|Secondary|Cmax and Ctau of DTG|The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
49546|NCT01328041|Secondary|Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|ITT-E Population||Participants|||Number
49547|NCT01328041|Secondary|Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48|The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.|Baseline; Weeks 4, 12, 24, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||ratio||Inter-Quartile Range|Median
49590|NCT01327599|Primary|Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|All subjects using Ganfort at baseline who received study medication and attended Week 12 visit.||millimeters mercury (mmHg)||Standard Deviation|Mean
49548|NCT01328041|Secondary|Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion|Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
49549|NCT01328041|Secondary|Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48|Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.|Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
49550|NCT01328041|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion|Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Log10 copies/mL||Standard Deviation|Mean
49551|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion.|ITT-E Population||Participants|||Number
49552|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window|Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population||participants|||Number
49553|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population||Participants|||Number
49554|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population||participants|||Number
49555|NCT01328041|Primary|Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to the DAIDS grading scale. The DAIDS displays events as Grades 1-4 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, potentially life threatening.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population||participants|||Number
49567|NCT01327989|Secondary|Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram|"Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow~Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Minutes||Standard Deviation|Mean
49556|NCT01328041|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population: all participants who received at least one dose of study drug||participants|||Number
49557|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 48|ITT-E Population||participants|||Number
49558|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24|The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 24|ITT-E Population||participants|||Number
49559|NCT01328041|Primary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8|Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.|Baseline and Day 8|Intent-to-Treat-Exposed (ITT-E) Population: all participants who received at least one dose of study drug. Only participants who had Day 8 observations were considered for analysis.||log10 copies/milliliter (mL)||Standard Deviation|Mean
49560|NCT01327989|Primary|Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).|Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.|90 Days|||percentage of events|||Number
49561|NCT01327989|Secondary|Immediate Flow Reperfusion|"Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus – Thrombolysis in Cerebral Infarction (TICI) score 2b or 3.~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|procedure|Due to insufficient imaging, the Core Lab was able to evaluated data from 190 subjects.||percentage of participants|||Number
49562|NCT01327989|Secondary|Incidence of Symptomatic Intracranial Hemorrhage|"Symptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs.~PH1 – Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 – Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH – Any intraparenchymal hemorrhage remote from the ischemic field IVH – Intraventricular hemorrhage SAH – Subarachnoid hemorrhage"|24 hours|||percentage of particpants|||Number
49563|NCT01327989|Secondary|Rate of Mortality||90 Days|||percentage of particpants|||Number
49564|NCT01327989|Secondary|Rate of Morbidity||90 Days|||percentage of particpants|||Number
49565|NCT01327989|Secondary|Good Neurological Condition|Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation|90 Days|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||percentage of particpants|||Number
49566|NCT01327989|Secondary|Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram|"Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow~Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During Procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Minutes||Standard Deviation|Mean
50070|NCT01319877|Primary|Percentage of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|36 months|||percentage of participants|||Number
49568|NCT01327989|Primary|Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.|"Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|Immediately post procedure|Due to insufficient imaging, the Core Lab was able to evaluate data from 190 subjects.||percentage of particpants|||Number
49569|NCT01327976|Primary|Percentage Responder Rate in the Treatment Arm.|The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.|12 months|||percentage of subjects|||Number
49570|NCT01327976|Primary|Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.|Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).|12 months|||percentage of excess weight loss||95% Confidence Interval|Mean
49571|NCT01327976|Primary|Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).|To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.|12 months|An intent-to-treat analysis was performed in the vBloc group.||percentage of participants||95% Confidence Interval|Number
49572|NCT01327703|Secondary|Nutritional Status as Assessed by Hematocrit Level|Nutritional status of participants was assessed by determining their hematocrit level. Mean hematocrit level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.||proportion of hematocrit||Standard Deviation|Mean
49573|NCT01327703|Secondary|Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level|Nutritional status of participants was assessed by determining their albumin, serum transferrin and hemoglobin level. Mean albumin, serum transferrin and hemoglobin level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.||gram/L (g/L)||Standard Deviation|Mean
49574|NCT01327703|Secondary|Nutritional Status as Assessed by Electrolytes Level|Nutritional status of participants was assessed by determining their electrolytes (sodium, potassium and chloride) level. Mean electrolytes level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.||millimole/L (mmol/L)||Standard Deviation|Mean
49575|NCT01327703|Secondary|Nutritional Status as Assessed by Body Mass Index (BMI)|Nutritional status of participants was assessed by determining their BMI. BMI was calculated by dividing body weight (kg) by square of height in meter (m). Mean BMI was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.||kg/m^2||Standard Deviation|Mean
49576|NCT01327703|Secondary|Nutritional Status as Assessed by Body Weight|Mean body weight was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.||kg||Standard Deviation|Mean
49577|NCT01327703|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence regardless of its causal relationship to study drug. A TEAE was defined as any event not present prior to exposure to study drug or any event already present that worsens in either intensity or frequency following exposure to test drug. A SAE was defined as any event that results in death, is immediately life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or is assessed as medically important.|Baseline up to 30 days after last dose|Safety population included all randomized participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) specifies number of participants who were evaluable for this measure.||participants|||Number
49578|NCT01327703|Secondary|Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data. Percent CFA was calculated separately for participants who used and did not use acid suppressing therapy (PPIs) during the study.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population. Here, 'n' specifies number of participants who were evaluable for specific categories for each arm group, respectively.||percent CFA||Standard Error|Least Squares Mean
49579|NCT01327703|Secondary|Percentage of Participants With Abdominal Distension|Abdominal distension is a sense of increased abdominal pressure by the participant that involves an actual measurable change in the circumference of a participant’s abdomen on physical examination. Percentage of participants with abdominal distension was calculated for each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who had abdominal distension assessment at screening and end of specified treatment.||percentage of participants|||Number
49580|NCT01327703|Secondary|Relative Frequency of Days With Abdominal Symptoms|Abdominal symptoms included abdominal pain and flatulence. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). For each type of abdominal symptom, the relative frequency of days with the symptom for each participant in a treatment period was calculated as the number of days in which the symptom was reported divided by the total number of days in which the abdominal symptom case report form (CRF) was completed. Mean relative frequency of days with abdominal symptoms was calculated during each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who were evaluable for this outcome measure and 'n' specifies the number of participants with at least one report of the symptom at that severity level during a treatment period.||days||Standard Deviation|Mean
49581|NCT01327703|Secondary|Mean Weight Per Stool Sample|Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.||gram||Standard Deviation|Mean
49582|NCT01327703|Secondary|Total Weight of Stools|Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.||gram||Standard Deviation|Mean
49583|NCT01327703|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as formed hard, normal or soft stool and abnormal consistency was defined as loose and unformed, liquid stool and diarrhea. Percentage of stools with normal consistency of each participant was calculated as the number of stools with normal consistency relative to the total number of stools during the collection period. Mean percentage of stool with normal consistency during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) specify signifies those participants who were evaluable for this outcome measure.||percentage of stools||Standard Deviation|Mean
49584|NCT01327703|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|Intent-to-treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||stools per day||Standard Deviation|Mean
49585|NCT01327703|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population included all randomized participants who completed both treatment periods and had all bowel movements appropriately collected with no major protocol violations/deviations or other events considered to potentially bias the study evaluations.||percent CFA||Standard Error|Least Squares Mean
49586|NCT01327599|Secondary|Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4|All subjects using Ganfort at baseline who received study medication and attended Week 4 visit.||millimeters mercury (mmHg)||Standard Deviation|Mean
49587|NCT01327599|Secondary|Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4, Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.||percentage of participants|||Number
49588|NCT01327599|Secondary|Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline|Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.||units on a scale||Standard Deviation|Mean
49589|NCT01327599|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.||Units on a scale||Standard Deviation|Mean
49591|NCT01327547|Secondary|Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48|Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||kPa||Standard Deviation|Mean
49592|NCT01327547|Secondary|Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48|"The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1).~ELF score < 7.7: no to mild fibrosis; ≥ 7.7 — < 9.8: Moderate fibrosis; ≥ 9.8 — < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis."|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||ELF score||Standard Deviation|Mean
49593|NCT01327547|Secondary|Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48|Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||IU/L||Standard Deviation|Mean
49594|NCT01327547|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) RNA at Week 48|Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||IU/L||Standard Deviation|Mean
49595|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48|Plasma samples were used to determine markers of immune activation namely TGF beta.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||ng/L||Standard Deviation|Mean
49596|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: D Dimer - Week 48|Plasma samples were used to determine markers of immune activation namely D-Dimer.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||ng/dL||Standard Deviation|Mean
49597|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48|Plasma samples were used to determine markers of immune activation namely CRP.|48 weeks|||mg/dL||Standard Deviation|Mean
49598|NCT01327547|Secondary|Change From Baseline in Markers of Immune Activation: CD38 Expression on CD4 and CD8 Cells - Week 48|Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||cell/mm³||Standard Deviation|Mean
49599|NCT01327547|Secondary|Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48|Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Cells/µL||Standard Deviation|Mean
49600|NCT01327547|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48|The Food and Drug Administration (FDA’s) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the “virology-first principle” and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Percentage of participants|||Number
49601|NCT01327547|Secondary|Percentage of Participants With Hy's Law Abnormalities at Week 48|Hy’s law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Percentage of participants|||Number
49949|NCT01322594|Primary|Incidence of Clinically Significant Serum Chemistry Laboratory Results|Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
49602|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 48 Associated With a Change From Baseline ALT >100 IU/L|Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 48-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Days|||Number
49603|NCT01327547|Secondary|Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L at Week 48|Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 48-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Percentage of participants|||Number
49604|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 48|Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for subjects whose baseline ALT ≤ULN, or >3.5x baseline for subjects whose baseline ALT >ULN, at Week 48.|48 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, LOCF was used if the value at that timepoint was missing.||Days||95% Confidence Interval|Median
49605|NCT01327547|Primary|Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48|Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the Full Analysis Set (FAS) which included participants who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 48, last observation carried forward (LOCF) was used if the value at that timepoint was missing.||Percentage of participants|||Number
49606|NCT01327508|Secondary|Distal Locking Time|Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.|Intraoperative|||minutes||Standard Deviation|Mean
49607|NCT01327508|Primary|Radiation Exposure Measurement|"Radiation exposure measured in two ways:~Whole body badge TLD ring badge"|Intraoperative|Primary endpoint voided. Dosimeters did not capture radiation dose as expected.|||||
49608|NCT01327482|Secondary|Plasma Raltegravir Concentrations|Mean trough concentration from all 3 days|7, 14, 21 days|||ng/mL||Standard Deviation|Mean
49609|NCT01327482|Primary|Tissue Raltegravir Concentrations|Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.|7, 14, 21 days|||ng/mL||Standard Deviation|Mean
49610|NCT01327339|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|one month|ITT Population||participants|||Number
49611|NCT01327339|Secondary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|one month|ITT Population||participants|||Number
49612|NCT01327339|Primary|Number of Participants With Any Adverse Event|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|one month|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments.||participants|||Number
49613|NCT01327313|Secondary|Accumulation Ratio (Rac)|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at 3rd infusion divided by area under the serum concentration-time curve within one complete dosing interval at 1st infusion.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 and Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
49614|NCT01327313|Secondary|Percentage Peak-Trough Fluctuation (PTF)|The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [Cmax - Cmin] / Cav ) multiplied by 100.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
49615|NCT01327313|Secondary|Mean Residence Time at Steady State (MRTss)|MRTss = (AUMCtau + tau(AUCinf – AUCtau))/ AUCtau) - T/2, where AUMCtau was the area under the first moment curve within one complete dosing interval and T was the infusion duration. Area under the serum concentration-time curve from time zero to infinity, calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour||Geometric Coefficient of Variation|Geometric Mean
49616|NCT01327313|Secondary|Mean Residency Time (MRT0-inf)|MRT0-inf of drug in the body was calculated by dividing the area under the first moment curve from time zero to infinity with area under the first moment curve from time zero to infinity minus half of infusion of duration (MRT0-inf = AUMC0-inf/AUMC0-inf - T/2).|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour||Geometric Coefficient of Variation|Geometric Mean
49617|NCT01327313|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||liter||Geometric Coefficient of Variation|Geometric Mean
49618|NCT01327313|Primary|Apparent Volume of Distribution: After Multiple Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/(Area under the serum concentration-time curve within one complete dosing interval [AUCtau]* λz) following multiple dose.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||liter||Geometric Coefficient of Variation|Geometric Mean
49619|NCT01327313|Primary|Pharmacokinetics of EMD 525797 - Trough Values|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49620|NCT01327313|Primary|Apparent Volume of Distribution (Vz): After Single Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the serum concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. A minimum of three points is required to calculate λz.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||liter||Geometric Coefficient of Variation|Geometric Mean
49621|NCT01327313|Primary|Total Body Clearance at Steady State (CLss) of EMD 525797|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL of drug in serum was calculated as : CL= Dose/ AUC0-inf. Area under the serum concentration-time curve from time zero to infinity (AUC0-inf), calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
49622|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49623|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49624|NCT01327313|Secondary|Average Serum Concentration at Steady State (Cav)|The Cav was calculated by dividing the area under the serum concentration-time curve within one complete dosing interval (AUCtau) by the dosing interval (2 weeks or 336 hoursi.e. Cav =AUCtau/tau).|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49625|NCT01327313|Secondary|Observed Serum Concentration Immediately Before Next Dosing (Cpre)|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration)|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
52461|NCT01292226|Secondary|Percentage of Participants With Hematologic Toxicity|Hematological toxicities graded according to WHO worst grade observed (Grade 1=mild, Grade 2=moderate).|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population||percentage of participants|||Number
49626|NCT01327313|Secondary|Minimum Observed Serum Concentration (Cmin) After Multiple Doses|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49627|NCT01327313|Secondary|Elimination Rate Constant ( λ z): After Multiple Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||per hour||Geometric Coefficient of Variation|Geometric Mean
49628|NCT01327313|Secondary|Elimination Rate Constant (λz): After Single Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||per hour||Geometric Coefficient of Variation|Geometric Mean
49629|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour||Full Range|Median
49630|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour||Full Range|Median
49631|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour||Full Range|Median
49632|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour||Full Range|Median
49633|NCT01327313|Secondary|Progression-free Survival (PFS)|PFS time was defined as the time (in months) from the first dosing date to the date of first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST version 1.0) or death for any cause within 12 weeks after last tumor assessment. Subjects without event are censored on the date of last tumor assessment.|From first dosing date until disease progression or death, maximum up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.||months||Full Range|Median
49634|NCT01327313|Secondary|Number of Subjects With Clinical Benefit|Clinical benefit was defined as presence of at least one confirmed CR, PR, or stable disease (SD) lasting at least 12 weeks according to RECIST v1.0. Per RECIST v1.0: CR was defined as disappearance of all target and non-target lesions and normalization of serum levels of tumor markers . PR was defined as >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.||subjects|||Number
49635|NCT01327313|Secondary|Number of Subjects With Overall Tumor Response|Overall tumor response was defined as the presence of at least one confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Complete response was defined as the disappearance of all target and non-target lesions and normalization of serum levels of tumor markers. PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.||subjects|||Number
49636|NCT01327313|Primary|Total Body Clearance (CL) of EMD 525797: After Single Dose|Total body clearance of drug in serum was calculated: as CL= Dose divided by Area under the serum concentration-time curve from time zero to infinity (AUC0-inf).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
49637|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Multiple Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above LLQ.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49950|NCT01322594|Primary|Incidence of Clinically Significant Vital Signs Results|Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
49638|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Single Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above Lower limit of quantification (LLQ).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49639|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax) of EMD 525797:After Multiple Dose||Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
49640|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax): After Single Dose||Pre-dose, hour 1(end of infusion [EOI]), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The pharmacokinetic (PK) analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
49641|NCT01327313|Primary|Number of Subjects With Dose-limiting Toxicities (DLTs)|DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring at any dose level until the end of Week 4, and suspected to be reasonably related to the investigational medicinal product by the Investigator and/or Sponsor. Toxicities not considered to be DLTs are as follows- Allergic reactions or anaphylaxis; any Grade 3 or 4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days, unless the Investigator decided this event is clinically significant. For this reason Grade 3 or 4 out-of-range laboratory values must be re-assessed within 7 days. In case the Investigator provides the subject any treatment(s) due to the out-of-range laboratory values, the event was regarded as a DLT.|Baseline up to Week 4|Dose escalation analysis set/DLT analysis set included all subjects who experienced a DLT or subjects who did not experience a DLT and had a relative dose intensity of >= 75 percent (%) during the DLT observation period.||subjects|||Number
49642|NCT01327300|Secondary|Intestinal Permeability Testing|"Ability of test substances to permeate the intestinal mucosa. The Lactulose/Mannitol test (Genova Diagnostics®, Ashville, NC) directly measures the ability of mannitol and lactulose to permeate the intestinal mucosa. Patient ingests 5 grams of lactulose and 2 grams of mannitol dissolved in a 100 ml of water. Urine is then collected for 24 hours and the ratio of the urinary excretion of lactulose to mannitol is measured. This testing is performed only after completion of each treatment period , after 12 weeks of mesalamine and after 12 weeks of placebo.~Normal ratio of lactulose/mannitol is any value <0.7. An abnormal ratio is defined as >0.7 ratio. The lactulose is measured in the urine as g/kg and the urinary excretion of mannitol is also measures as g/kg."|At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|||ratio||Full Range|Mean
49643|NCT01327300|Secondary|Hospital Anxiety and Depression Scale (HADS)|"A questionnaire is given to each patient with scoring done on a Likert scale ranking from 0-42 which combines anxiety and depression scales. Each of these are scored from 0-21 depending on anxiety versus the depression parameters. Comparison of change in HADs after 12 weeks of intervention with either mesalamine or placebo is provided here with only the total value provided-range is from 0-42.~Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 3 with zero being none at all or occasional and 3 as most of the time. The scale used is a Likert scale and therefore the data returned from the HADS is ordinal.~The best score for the HADS therefore is a 0 with the worst score a 42 for combined anxiety and depression scores.~For the subscales of depression and anxiety, the best score is a 0 and the worst is a 21. This data is not provided here.~Data below includes the change from baseline in the HADS scores."|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|||units on a scale||Standard Deviation|Mean
49644|NCT01327300|Secondary|IBS - Quality of Life (IBS-QOL)Score.|A questionnaire is given to each patient and was completed at baseline then after 12 weeks of intervention with mesalamine and then placebo in the cross-over study. The IBS-QOL comprises 34 items with 5-point response scales (0 to 4) that cover eight dimensions of HRQL: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items),food avoidance (3 items), social reaction (4 items), sexual concerns (2 items) and relationships (3 items). Higher values indicate better HRQL after converting the raw score on the IBS-QOL into 0 to 100 points.|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|Data are the mean change in IBS-QOL between baseline and intervention||units on a scale||Standard Deviation|Mean
49645|NCT01327300|Secondary|Functional Bowel Disorder Severity Index (FBDSI)|Subjects rate pain on a standardized scale. This is a standardized test used to evaluate patients with IBS. Baseline values are compared to 12 weeks after mesalamine and 12 weeks after placebo treatments. The FBDSI is score is interpreted as such: Severity of IBS is rated as none (0 points), mild (1-36 points), moderate as 37-110 points and severe as >110 points. Therefore patients can have a score higher than 110.|An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period.|Change in Functional Bowel Disorder Severity Index (FBDSI)after 12 weeks of intervention.||units on a scale||Standard Deviation|Mean
49646|NCT01327300|Secondary|Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline.|"Colonoscopy/flexible sigmoidoscopy will be performed and mucosal biopsies will be obtained. Each biopsy was stained for activated t lymphocytes, mast cells and eosinophils .~CD117 staining was done for Mast cells. H and E staining was used to identify lymphocytes and eosinophils. Each path specimen was then noted to have increased versus normal number of these inflammatory cells."|For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years)|||participants|||Number
52462|NCT01292226|Secondary|Percentage of Participants With Gastrointestinal Toxicities|Gastrointestinal adverse events (AEs) according to WHO worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)|Safety population||percentage of participants|||Number
49647|NCT01327300|Primary|Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo|Patients rated the severity of their GI symptoms. The GIS scale goes from 1 to 7 with 1 being the worse and 7 as the best score showing improvement in symptoms. The GIS was performed at week one and at week 12 during each of the interventions. The comparisons below list the mean difference for each intervention from baseline (BL) with standard deviations then we list the p-value for the differences of baseline to intervention are reported using the Mann-Whitney test with a two-tailed p value provided.|Baseline and at 12 weeks post-intervention|The first part of the analysis compares the differences between baseline and mesalamine to baseline and placebo. The P value provided below list the comparison of baseline-placebo to baseline-mesalamine using the Mann-Whitney statistical analysis.||units on a scale||Standard Deviation|Mean
49648|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review - Per FAS|Rate of complete response is the proportion of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR will be determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of ‘Unknown” will be treated as non responders|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.||Percentage of participants||95% Confidence Interval|Number
49649|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review - Per pEAS|Rate of complete response is the proportion of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR will be determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of ‘Unknown” will be treated as non responders|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, and including all patients with mBCC included in the FAS.||Percentage of participants||95% Confidence Interval|Number
49650|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC Per FAS|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.~Median DoR for patients with laBCC was non-estimable for both treatment arms. Median DoR was non-estimable for patients with mBCC receiving treatment with sonidegib 200 mg.~Duration of response was for participants with ORR."|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.||Months||95% Confidence Interval|Median
49651|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC -Per pEAS|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.~Median DoR for patients with laBCC was non-estimable for both treatment arms as limited numbers of progressive disease (PD) or deaths were observed as of the 28-Jun-2013 data cut-off date. Median DoR was non-estimable for patients with mBCC receiving treatment with sonidegib 200 mg.~Duration of response was for participants with ORR."|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, and including all patients with mBCC included in the FAS.||Months||95% Confidence Interval|Median
49652|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS)|ORR is the proportion of patient’s objective response (ORR) by 6 months after starting LDE225 treatment. A responder will be defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher.|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by magnetic resonance imaging (MRI) or photography or both, and including all patients with mBCC included in the full analysis set (FAS).||Percentage of participants||95% Confidence Interval|Number
49653|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS).|ORR is the proportion of patient’s objective response (ORR) by 6 months after starting LDE225 treatment. A responder will be defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher.|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.||Percentage of participants||95% Confidence Interval|Number
49654|NCT01326962|Secondary|Number of Participants With Erythrocyte Sedimentation Rate Abnormality|ESR is an acute phase reactant and is a measure of inflammation. It is measured in millimeter per hour (mm/hr).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
49655|NCT01326962|Secondary|Number of Participants With C-Reactive Protein Abnormality|CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||mg/L|||Number
49683|NCT01326026|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
49656|NCT01326962|Secondary|Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient’s Global Assessment of Pain (VAS); Patient’s Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
49657|NCT01326962|Secondary|Number of Participants With AE or SAE Related Discontinuation of Tocilizumab|It included participants who discontinued from the study due to occurrence of AE or SAE.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.||participants|||Number
49658|NCT01326962|Secondary|Number of Participants With Any Adverse Event and Serious Adverse Event|An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.||participants|||Number
49659|NCT01326962|Primary|Change in Fatigue as Measured Using the Fatigue Visual Analog Scale|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||units on a scale|||Number
49660|NCT01326962|Primary|Changes in Participant’s Fatigue Assessed Using the Mean FACIT-Fatigue Score|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, ‘n’ = number of participants analyzed at particular point of time.||Units on a scale|||Number
49661|NCT01326962|Primary|Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response|Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
49662|NCT01326962|Primary|Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)|DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
49663|NCT01326962|Primary|Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
49726|NCT01325493|Primary|Morphine Equivalent Consumption (mg/kg)|Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.|at 24, 48, 72, 96 hours post operatively|||mg/kg||Standard Deviation|Mean
52040|NCT01297465|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||IU||Standard Deviation|Mean
49664|NCT01326962|Primary|Time to Das28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.||Day||Standard Error|Mean
49665|NCT01326962|Primary|Number of Participants Who Achieved Remission (DAS28 < 2.6)|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.||participants|||Number
49666|NCT01326962|Primary|Disease Activity as Measured by Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.||units on a scale||Inter-Quartile Range|Median
49667|NCT01326910|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA)|An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.|through Week 3|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
49668|NCT01326910|Secondary|Assessment of Itch|Subject’s or caregiver’s assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable|through Week 3|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
49669|NCT01326910|Secondary|Interim Eczema Area and Severity Index (EASI)|Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.|Week 2|Intention to Treat||participants|||Number
49670|NCT01326910|Primary|Eczema Area and Severity Index (EASI)|A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72|3 weeks|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
49671|NCT01326845|Secondary|Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months||||||
49672|NCT01326845|Secondary|Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups||3 months, 6 months||||||
49673|NCT01326845|Secondary|the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months||||||
49674|NCT01326845|Secondary|Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6||||||
49675|NCT01326845|Secondary|Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6||||||
49676|NCT01326845|Secondary|Difference in Severity of Overall GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.||||||
49677|NCT01326845|Secondary|Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.||||||
49678|NCT01326845|Secondary|Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.|Study was prematurely terminated and not powered for efficacy.|6 months||||||
49679|NCT01326845|Primary|Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms|Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section.|3 months||||||
49680|NCT01326533|Secondary|Beta Cell Function|Change from baseline in the disposition index (DI)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data||arbitrary units||Standard Error|Mean
49681|NCT01326533|Primary|Insulin Sensitivity|Change from baseline in the insulin sensitivity index (Si)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data||10^-4/pmol*l/min||Standard Error|Mean
49682|NCT01326026|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Episodes/100 years of patient exposure|||Number
49684|NCT01326026|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.||Events/100 years of patient exposure|||Number
49685|NCT01326026|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
49686|NCT01326026|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
49687|NCT01325870|Secondary|Mean Intrathoracic Pressure (Airway Pressure)|Intrathoracic pressures are reported relative to atmospheric pressure|during CPR (day 1)|||mmHg||Standard Deviation|Mean
49688|NCT01325870|Primary|Serious Adverse Events|Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR|during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up|||events|||Number
49689|NCT01325870|Primary|Mean Systolic and Diastolic Blood Pressures||during CPR (day 1)|||mmHg||Standard Deviation|Mean
49690|NCT01325792|Secondary|Early and Long-term Complication Rates|Surgical site abdominal wound event rate|after surgery (day 1) to 24 months|||% of subjects with events|||Number
49691|NCT01325792|Primary|Hernia Recurrence Rate|Investigator confirmed hernia recurrence by physical examination|at about 24 months|||% of subjects with recurrent hernia||95% Confidence Interval|Number
49692|NCT01325714|Secondary|Caregiver-perceived Mutuality|"Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale.~Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal.~responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported mutuality.||units on a scale||Standard Deviation|Mean
49693|NCT01325714|Secondary|Caregiver Burden|"Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always.~Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver burden.||units on a scale||Standard Deviation|Mean
49694|NCT01325714|Secondary|Pleasant Events - Short Form - Alzheimer's Disease|"The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease.~For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no).~For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together.~The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events."|Baseline, 0, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in frequency of pleasant events.||units on a scale||Standard Deviation|Mean
49695|NCT01325714|Secondary|Depression|"Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item.~Total GDS scores range from 0 to 30, with greater scores indicating greater depression."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
49696|NCT01325714|Secondary|Patient-reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
49697|NCT01325714|Secondary|Caregiver Reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months.|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
49698|NCT01325714|Secondary|Patient-reported Worst Pain.|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in patient-reported worst pain.||units on a scale||Standard Deviation|Mean
49699|NCT01325714|Secondary|Caregiver-Reported Worst Pain|"This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity"|Baseline, 3 months, 6 months, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.||units on a scale||Standard Deviation|Mean
49700|NCT01325714|Primary|Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)|"The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred less than once a week or more often) and disruptiveness (i.e., it was a little disruptive or more), he/she was considered aggressive.~Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors.~One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors.~One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors."|Three Months, Six Months, Twelve Months Post Intervention|203 community-dwelling Veterans with pain and dementia and their caregivers||participants|||Number
49701|NCT01325701|Secondary|Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|"Treatment Group 1 PK collection schedule:~Cycle 1 Day 1: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 8: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose~Treatment Group 2 PK collection schedule:~Cycle 1 Day 8: Pre-dose, 1, 2, 4 and 7 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose Cycle 3 Day 1: Pre-dose, 1, 2, and 4 hours post-dose"|Performed during the first month of receiving study drug.|PK samples were collected in all participants (n=70 and 8 in PCI-32765: 560 mg and 840 mg, respectively). Of these, 59 participants in PCI-32765: 560 mg and 7 in PCI-32765: 840 mg on Cycle 1 Day 8 were evaluable for PK.||ng*h/mL||Standard Deviation|Mean
49702|NCT01325701|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Participants will be followed until progression of the disease or start of another anticancer treatment. The clinical database captured all AEs from baseline through end of treatment. Treatment Emergent AEs were collected pre-dose, at the beginning of each cycle and 30 days post last dose of study drug, unless related to study drug.|Adverse events determined to be related to study drug are collected from first dose until study exit.|||participants|||Number
49703|NCT01325701|Primary|Percentage of Patients With an Overall Response to Study Drug|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin’s lymphoma (Cheson et al, 2007), as assessed by the investigator.|The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months)|PCI-32765: 840 mg: A total of 8 subjects were enrolled and followed through their first response assessment. Due to a lack of positive responses observed, enrollment to this Treatment Group was terminated for futility.1 out of 8 = ORR = 12.5%. Response rate reported for the 840 mg should not be generalized due to the study’s small sample size.||percentage of participants|||Number
49704|NCT01325623|Secondary|Post-stimulation Heart Rate Changes|During a 1 hour period during the EMU stay, the VNS Therapy device was programmed to normal mode stimulation ON time 30 seconds, OFF time 5 minutes. AutoStim and Magnet Mode were programmed OFF. In this hour, 10 to 11 normal mode stimulations can be expected. Around each of these stimulations, ECG data were collected to assess potential stimulation related heart rate changes (during stimulation, after stimulation and after black-out time). A black-out time is a period after stimulation during which no seizure detections can occur, to ensure that potential stimulation related heart rate changes were not seen as ictal tachycardia that would trigger false positive detection. During the trial, the black-out time was programmed to 30 seconds. The heart rate changes for all stimulations and all patients were averaged.|EMU stay|ITT population||percentage change||Standard Deviation|Mean
49705|NCT01325623|Secondary|Overall Summary of Seizure Intensity by Subgroup|Quantitative evaluation of EEG was used to characterize the seizures that were treated with Automatic Stimulation. Intensity was evaluated by surveying the average power level from the 10-20 system EEG channel of maximum output during the course of the seizure. Intensity was only reported for seizures with intensity annotated and >= 20% Heart Rate Rise. The relative intensity was calculated by normalizing the power calculations to the pre-seizure state, and thus the reported changes are dimensionless. n= number of seizures|Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay|Patients from the ITT population who had at least one seizure during EMU stay and who had at least one historical seizure recorded. n=total number of seizures||unitless||Standard Deviation|Mean
49706|NCT01325623|Secondary|Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P)|Quality of life data was collected using patient‐completed QOLIE‐31‐P surveys and compared between baseline and follow‐up visits. The MIC score for each subscale defines the threshold for Minimally Important Change. If a score exceeds the MIC Score, the improvement from baseline is considered clinically significant. The range for QOLIE-31-P (all sub-scores) is 0-100 with higher scores reflecting greater well-being.Subscale scores were averaged to compute the QOLIE Total Score.|up to 24 Months Visit|ITT Population||units on a scale||Standard Deviation|Mean
49707|NCT01325623|Secondary|Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Post-ictal duration was quantified by identifying the time at which the number of EEG channels within the 95% confidence interval of relative power reaches a number that is consistent with that during the pre-seizure period. This measure represents the amount of time required following a seizure until the EEG recovers to the pre-seizure state. It is used to objectively estimate patient recovery time. Historical seizures were baseline EEG recordings measured during monitoring prior to implantation. Post-ictal duration is only reported for seizures with Post Ictal Duration (seconds) annotated and >= 20% Heart Rate Rise|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures||Seconds||Standard Deviation|Mean
49727|NCT01325428|Secondary|Progression Free Survival Over the Whole Sudy.|PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.|From first drug administration until end of study, up to 700 days.|"TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.~TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B."||Days||95% Confidence Interval|Median
49708|NCT01325623|Secondary|Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Seizure duration was calculated using historical EEG data from patients enrolled in the trial and compared to the duration of seizures that occurred during the study EMU stay. The seizure start and end times were determined via clinical observation and/or through an adjudication process with qualified EEG reviewers.|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures||Seconds||Standard Deviation|Mean
49709|NCT01325623|Secondary|Proportion of Seizures Ending During Stimulation by Type|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population; All Treated Seizures n=total number of seizures||Percentage of Seizures Ending|||Number
49710|NCT01325623|Secondary|Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 and 24 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.~Mean SSQ scores at 3, 6, 12, 18 and 24 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire. Subscale scores were averaged to compute the SSQ Total Score"|Up to 24 Month visit|ITT Population||Units on a scale||Standard Deviation|Mean
49711|NCT01325623|Secondary|Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.~Negative median value means improvement."|up to 24 Months Visit|ITT Population||Units on a scale||Full Range|Median
49712|NCT01325623|Secondary|Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6, 12, 18 and 24 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 24 Month visit|ITT population||Percentage of participants||95% Confidence Interval|Number
49713|NCT01325623|Secondary|Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from Extremely Difficult (5) to Extremely Easy (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery and the end of EMU.~Usability was calculated as percentage of the users who found the usability of system to be easy-2 or extremely easy-1."|At implant/recovery up to EMU Discharge (2 to 4 weeks)|ITT Population||Percentage of participants rated 1 or 2|||Number
49714|NCT01325623|Secondary|Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting|Latency is defined as the time difference between SDA detection time and the annotated seizure onset time. The earliest SDA detection was considered for each seizure. Seizure onset times were compared with M106 device detections at the randomized SDA setting. Negative latencies indicate that the SDA detection preceded the seizure onset time. The median latency is presented for seizures which met the definition of ictal tachycardia as well as all seizure types and indicate the observed latency range.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population n=total number of seizures in each category||seconds||Full Range|Median
49715|NCT01325623|Secondary|Validation of Cardiac R-Wave Detection|Cardiac R‐wave detection was evaluated against concurrent ECG data (i.e. detailed R‐wave test) collected during implant, the first titration visit, at the beginning of the EMU stay, and at the 12 month visit. R‐R intervals were calculated using detected R‐waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre‐specified time interval. A time series 10 seconds was recorded using the IPG SyncPulse feature. Simultaneously, a corresponding time series over the same interval was recorded using a standard ECG monitor. The total number of beats accurately detected in the entire study population is reported.|At Implant, First Titration Visit, Day 1 EMU and 12 Months|ITT population||percentage of beats accurately detected|||Number
49716|NCT01325623|Primary|Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Potential false positive rate is defined as the sum across all patients of the total number of potential false positive detections divided by the sum across all patients of the appropriate monitoring time during the EMU stay. Data used to support the potential false positive rate analyses included digital ECG/EEG files retrieved from the EMU evaluation, corresponding M106 device downloads, and triple review results of EEG recordings.~The evaluated EMU monitoring time includes a daily 3 minutes stepping exercise during which patients stepped up and down on a step stool at a submaximal effort leve."|Epilepsy Monitoring Unit (EMU) Stay|"ITT Population: all patients implanted with Model 106 VNS Therapy System Version 2 and who have any EMU record.~10 participants analyzed for >=60% setting, 12 participants analyzed for >=40% setting, 8 participants analyzed for >=20% setting."||Potential False Positive per Hour||95% Confidence Interval|Number
49728|NCT01325428|Secondary|Part B: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.|From first drug administration until end of Part B, up to 230 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Days||95% Confidence Interval|Median
49717|NCT01325623|Primary|Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).||percentage of True Positive Detections||95% Confidence Interval|Mean
49718|NCT01325623|Primary|Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Sensitivity is the total number of seizures detected divided by the total number of seizures during EMU stay.Data used to support sensitivity analyses included digital ECG/EEG files,corresponding M106 device downloads,and CRF data.Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define EEG seizure onset times.Seizure onset times were then compared with observed M106 device detections at the detection threshold setting for AutoStim that the patient was randomized to(SDA 2;60%,SDA 4;40%,SDA 6;20%).Sensitivity is only reported if the heart rate surpassed the programmed detection threshold.Number of participants is total number of subjects who had seizures during the EMU stay.~An Ictal tachycardia Seizure is a seizure with Ictal Heart rate >= 100 bpm & at least 55% increase, or 35 bpm increase from baseline) Bootstrap confidence intervals using 3000 bootstrap samples. n=total number of seizures; N= number of participants"|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).||percentage of True Positive Detections||95% Confidence Interval|Mean
49719|NCT01325623|Primary|Summary of Seizures Reported by Investigators and Triple Review|"Subjects were admitted to the EMU and underwent standard continuous data collection of vEEG and ECG for 3 to 5 days. If a seizure occurred during the EMU stay, clinical investigators annotated the start and stop times, the type of seizure, the presumed seizure onset location, and the lobe of origin as applicable.~Following the EMU data collection phase of the trial, the de-identified, continuous electronic records (per patient) from the EMU period were provided to an independent and blinded triple review panel. This panel evaluated the EEG data and annotated seizure onset, seizure offset, and a description of seizure type. In the absence of video, seizure types could only be specified as: partial (particular type not denoted), generalized (non-absence), absence, or partial with secondary generalization."|Epilepsy Monitoring Unit Stay|ITT Population: consists of all patients implanted with the AspireSR VNS Therapy System version 2 and who have any EMU record.||Seizures|||Number
49720|NCT01325532|Secondary|Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.|The Pittsburgh Sleep Quality Index (PSQI) is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study. Scoring is based on 7 individual components. Each component is scored from 0-3. Higher scores indicate worse sleep. Total global sleep score ranges from zero (0) to 21. We report here the overall change in global sleep score for each treatment arm, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of sleep disturbance (improvement), whereas a score of less than zero indicates an increase in sleep disturbance (worsening).|Baseline-Week 3|This is an intent to treat (ITT) analysis of all patients randomized.||units on a scale||Standard Deviation|Mean
49721|NCT01325532|Primary|Reported Side Effects Based on PRISE AE Scores|This measures the emergence of different adverse (side) effects from treatment during the study. This section will describe the most commonly reported adverse effects. The section on adverse events will describe and detail the full range of AEs reported.|Baseline-Week 3|Intent to treat sample with all subjects randomized.||number of subjects reporting|||Number
49722|NCT01325532|Primary|Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3|The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52. This section reports the improvement in depressive symptoms during the course of treatment, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of depressive symptoms (improvement), whereas a score of less than zero indicates an increase in depressive symptoms (worsening).|Baseline-Week 3|Intent to treat sample with last observation carried forward for all randomized subject.||units on a scale||Standard Deviation|Mean
49723|NCT01325493|Secondary|Pain Score During Cough.|Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively|||pain score at cough||Standard Deviation|Mean
49724|NCT01325493|Secondary|Pain Score at Rest|Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively|||pain score at rest||Standard Deviation|Mean
49725|NCT01325493|Secondary|Sedation Score|"Sedation scores 0 = completely awake~= sleepy but responds appropriately~= somnolent but arouses to light stimuli~= asleep but responsive to deeper physical stimuli~= asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery."|24, 48, 72, 96 hours post operatively|||Sedation Score||Standard Deviation|Mean
49750|NCT01325311|Secondary|Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)||up to Day 35|||percentage of participants|||Number
49729|NCT01325428|Secondary|Part A: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.|From first drug administration until end of Part A, up to 713 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Days||95% Confidence Interval|Median
49730|NCT01325428|Secondary|Part B: Duration of Unconfirmed Objective Response.|Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).|From first drug administration until end of Part B, up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Days||95% Confidence Interval|Median
49731|NCT01325428|Secondary|Part A: Duration of Unconfirmed Objective Response.|Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).|From first drug administration until end of Part A, up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Days||95% Confidence Interval|Median
49732|NCT01325428|Secondary|Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Percentage of participants||95% Confidence Interval|Number
49733|NCT01325428|Secondary|Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Percentage of participants||95% Confidence Interval|Number
49734|NCT01325428|Secondary|Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Percentage of participants||95% Confidence Interval|Number
49735|NCT01325428|Secondary|Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Percentage of participants||95% Confidence Interval|Number
49736|NCT01325428|Primary|Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.||Percentage of participants||95% Confidence Interval|Number
49737|NCT01325428|Primary|Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.||Percentage of participants||95% Confidence Interval|Number
49738|NCT01325350|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Intensity units||Standard Deviation|Mean
49739|NCT01325350|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||mm/cm^2||Standard Deviation|Mean
49740|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
49741|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
49742|NCT01325350|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
49743|NCT01325350|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||terminal hairs/cm^2||Standard Deviation|Mean
49744|NCT01325337|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Intensity units||Standard Deviation|Mean
49745|NCT01325337|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||mm/cm^2||Standard Deviation|Mean
49746|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
49747|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
49748|NCT01325337|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||Percentage of participants|||Number
49749|NCT01325337|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.||terminal hairs/cm^2||Standard Deviation|Mean
49751|NCT01325311|Secondary|Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized case data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence."|Up to day Day 35|Due to sample in Arm II one participants data was not analyzed.||Normalized Optical Density||Standard Deviation|Mean
49752|NCT01325311|Secondary|Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized control data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence."|Up to Day 35|||Normalized Optical Density||Standard Deviation|Mean
49753|NCT01325311|Secondary|Total PTH in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm I was not analyzed.||ng/mL||Standard Deviation|Mean
49754|NCT01325311|Secondary|Total IGFBP-3 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study.|Baseline and Up to Day 35|Due to sample one participant from Arm 1 was not analyzed.||ng/mL||Standard Deviation|Mean
49755|NCT01325311|Secondary|Total IGF-2 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed.||ng/mL||Standard Deviation|Mean
49756|NCT01325311|Secondary|Total IGF-1 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study.|Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.||ng/mL||Standard Deviation|Mean
49757|NCT01325311|Secondary|Serum Calcium Levels at Baseline and Pre-Surgery|This is a measurement of calcium in the Blood serum at baseline and at the end of the study.|Baseline and Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.||ng/mL (absolute change)||Standard Deviation|Mean
49758|NCT01325311|Secondary|Total PSA in Serum|This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study.|at Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.||ng/mL||Standard Deviation|Median
49759|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP27B1|This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein.|Up to Day 35|||Ratio to Baseline||Standard Deviation|Geometric Mean
49760|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP24|This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein.|Baseline and Up to Day 35|Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome.||Ratio to Baseline||Standard Deviation|Geometric Mean
49761|NCT01325311|Secondary|Levels of Calcitriol in Participants Serum|This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.|baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.||ng/mL||Standard Deviation|Mean
49762|NCT01325311|Primary|Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms|To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein|up to 35 days|||participants|||Number
49763|NCT01325311|Secondary|Levels of Calcidiol in the Participants Serum|This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study|Baseline and up to day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.||ng/mL||Standard Deviation|Mean
49764|NCT01325311|Primary|Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms|This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein|up to Day 35|||ng/mL||Standard Deviation|Mean
49765|NCT01325181|Secondary|Number of Participants With Adverse Event|number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events|12 months||||||
49766|NCT01325181|Secondary|Number of Participants Who Underwent Rescue Treatment|number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group|12 months||||||
49767|NCT01325181|Secondary|Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography|change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period|12 months||||||
49768|NCT01325181|Secondary|Number of Participants With Leakage on Fluorescein Angiography|number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period|12 months||||||
49769|NCT01325181|Secondary|Change From Baseline in Central Foveal Thickness on OCT|the change from baseline in central foveal thickness measured by OCT throughout the follow-up period|12 months||||||
49770|NCT01325181|Primary|Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment|number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study|12 months|All study eyes were analyzed using intention to treat principle and the last observation forward method||participants|||Number
49771|NCT01325181|Secondary|Change From Baseline in logMAR BCVA|the changes from baseline in logMAR BCVA throughout the follow-up period|12 months||||||
49772|NCT01324947|Secondary|Time to Response Based on IMWG and Assessed by the Investigator|Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks|Includes those who had at least a partial response or better; Intent to Treat||weeks||Full Range|Median
49773|NCT01324947|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival was calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.|Intent to Treat population included all participants enrolled into the study||weeks||95% Confidence Interval|Median
49774|NCT01324947|Secondary|Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria|Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria.|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.|Includes those who had a partial response or better.||weeks||95% Confidence Interval|Median
49775|NCT01324947|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria|"Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG).~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.|Intent to Treat includes all participants enrolled||weeks||95% Confidence Interval|Median
49776|NCT01324947|Secondary|Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas."|From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.|Intent to Treat included all participants enrolled.||weeks||95% Confidence Interval|Median
49777|NCT01324947|Secondary|Number of Participants With Adverse Events and Type of Adverse Events|"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:~Results in death;~Is life-threatening;~Requires or prolongs existing inpatient hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Constitutes an important medical event.~The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):~Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death"|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
49778|NCT01324947|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and requires all of the following:~Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.~<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.~No increase in size or number of lytic bone lesions.~Disappearance of soft tissue plasmacytomas.~PR requires all of the following:~≥50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.~Reduction in 24-hour urinary light chain extraction by ≥90% or to <200 mg, maintained at least 42 days.~For patients with non-secretory myeloma, ≥50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to treat population includes all participants enrolled.||percentage of participants|||Number
49779|NCT01324947|Primary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to Treat Population was defined as all enrolled participants.||percentage of participants|||Number
49780|NCT01324882|Primary|Time to Intubate the Cecum|The time in seconds that it required to intubate the cecum as defined in our protocol.|This outcome was measured the day of the procedure.|||seconds||Standard Deviation|Mean
49784|NCT01324440|Primary|Number of Vaccine-related Serious Adverse Experiences|"Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol:~A serious adverse event (SAE) is any AE that:~results in death,~is life threatening,~results in a persistent or significant disability/incapacity,~results in or prolongs an existing inpatient hospitalization,~is a congenital anomaly/birth defect,~is a cancer,~is an overdose,~or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above."|Up to Day 360 postvaccination|Any subject who received clinical material and had at least 1 day of safety follow-up was included in the safety summary.||participants|||Number
49785|NCT01324440|Primary|Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)|"Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.~The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline."|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.||ratio of IgG titer at Day 14 to baseline||95% Confidence Interval|Geometric Mean
49786|NCT01324440|Primary|Geometric Mean Antibody Concentrations (GMC)|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.||mcg/mL||95% Confidence Interval|Geometric Mean
49787|NCT01324440|Primary|Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.||participants|||Number
49788|NCT01324401|Secondary|Desensitization|A five-fold increase in ED defined by OFC at the conclusion of maintenance therapy|at least 36 months|||Participants|||Count of Participants
49789|NCT01324401|Primary|Tolerance|Tolerance will be defined in this study as a loss of clinical sensitivity to peanut. Subjects will be considered to have achieved tolerance if the post treatment eliciting dose (ED), defined by the double blind placebo controlled food challenge, is five fold increase from the ED of baseline.|at least 36 months|||Participants|||Count of Participants
49790|NCT01324388|Primary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM blood pressure data.||millimeter of mercury (mm Hg)||Standard Deviation|Mean
49791|NCT01324388|Primary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM heart rate data.||beats per minute (bpm)||Standard Deviation|Mean
49792|NCT01324388|Primary|Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril||Day -1, Day 3, Day 24 in Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril Cmax data.||(nanograms per milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
49793|NCT01324388|Secondary|Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol Cmax data.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
49794|NCT01324388|Secondary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol AUC data.||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
49795|NCT01324388|Secondary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM blood pressure data.||millimeter of mercury (mm Hg)||Standard Deviation|Mean
49796|NCT01324388|Secondary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM heart rate data.||beats per minute (bpm)||Standard Deviation|Mean
49797|NCT01324388|Primary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril AUC data.||(nanograms*hours/milliliter)/milligram||Geometric Coefficient of Variation|Geometric Mean
49798|NCT01324349|Secondary|Number of Subjects With Treatment-emergent Adverse Events||Up to 30 days post surgery.|All treated subjects are included in the Safety population.||Participants|||Number
49799|NCT01324349|Secondary|Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness and will be discussed in this report. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil).||Participants|||Number
49800|NCT01324349|Primary|Median Time to Achieve Hemostasis Following Application of Study Treatment.|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil®).||Minutes||Full Range|Median
49801|NCT01324323|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after the last treatment)|The safety population included all subjects who received at least 1 dose of study drug.||participants|||Number
49802|NCT01324323|Primary|Apparent Total Volume of Distribution (Vz).|Apparent total volume of distribution (Vz) was calculated as [(CL)/λz] for Romidepsin and co-administered with Rifampin.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population was to consist of all participants who received at least 1 dose of study drug and had evaluable PK profiles.||Liters||Geometric Coefficient of Variation|Geometric Mean
49803|NCT01324323|Primary|Clearance (CL): Apparent Total Plasma Clearance.|The apparent total plasma clearance (CL) was calculated as [Dose/AUC0-∞] for Romidepsin alone and co-administered with rifampin plasma concentrations.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||L/hr||Geometric Coefficient of Variation|Geometric Mean
49804|NCT01324323|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|The terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]. This was only calculated when a reliable estimate for λz could be obtained.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||hours||Geometric Coefficient of Variation|Geometric Mean
49805|NCT01324323|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Time to maximum observed plasma concentration (Tmax) was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||hours||Full Range|Median
49806|NCT01324323|Primary|Maximum Observed Plasma Concentration (Cmax)of Romidepsin|Maximum observed plasma concentration (Cmax)was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
49807|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞).|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz]. λz is the apparent terminal rate constant. No AUC extrapolation was performed with unreliable λz. If the percentage of AUC extrapolated is ≥ 25%, AUC0–∞ will not be reported.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
49808|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin|Individual and mean romidepsin plasma concentrations by treatment and scheduled time data were collected. AUC0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 and Day 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
49809|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
49820|NCT01324271|Primary|Percentage of Tubes Successfully Placed Using a TTDS Device|"Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.~A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with “tube.” Tube is the outcome of the device use."|Day 0|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting||percentage of devices|Participants|95% Confidence Interval|Number
49810|NCT01324310|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|All 15 subjects in the safety population received at least 1 dose of romidepsin. AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after last treatment)|The safety population consisted of all participants who received at least 1 dose of study drug. The Day 8 analysis population included 13 participants because two participants discontinued from the study prior to Day 8 (one due to an AE, the other due to disease progression).||participants|||Number
49811|NCT01324310|Primary|Apparent Total Volume of Distribution (Vz)|Vz: apparent total volume of distribution, calculated as [(CL)/λz].|Days 1 and 8, At 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||Liter||Geometric Coefficient of Variation|Geometric Mean
49812|NCT01324310|Primary|Apparent Total Plasma Clearance (CL)|Apparent total plasma clearance, (CL) calculated as [Dose/AUC 0-∞].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||L/hr||Geometric Coefficient of Variation|Geometric Mean
49813|NCT01324310|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|Terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]|Days 1 and 8; at 0 (pre-dose),1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||hours||Geometric Coefficient of Variation|Geometric Mean
49814|NCT01324310|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Tmax: time to maximum observed Tmax, obtained directly from the observed concentration versus time data|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||hours||90% Confidence Interval|Median
49815|NCT01324310|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: maximum observed plasma concentration, obtained directly from the observed concentration versus time data; for Cmax, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
49816|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
49817|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC 0-24)|AUC 0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing; for AUC 0-24 an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion|Assess the influence of multiple doses of ketoconazole on the pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
49818|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. For AUC0-t, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% CI between romidepsin alone and romidepsin in the presence to ketoconazole.|Days 1 and 8; at 0 (pre-dose) 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assessment on the influence of multiple doses of ketoconazole on the Pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
49821|NCT01324271|Primary|Percentage of Subjects With In-office Tube Placement Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.|Day 0|||Percentage of Subjects||95% Confidence Interval|Number
49822|NCT01324128|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12|Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.|Week 12 post Baseline|For the Secondary Outcome, data from the Per Protocol Set (PPS) was used. The PPS consists of all subjects who had completed the analysis dose titration period (baseline to Week 12), had at least 1 evaluable serum phosphorus result at or after Week 12, and had no major protocol deviations.||mg/dL||Standard Error|Least Squares Mean
49823|NCT01324128|Primary|Change in Serum Phosphorus Levels From Week 24 to Week 27|Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27|Week 24, Week 27|For the Primary Outcome, data from the Primary Efficacy Set (PES) was used. The PES consists of subjects who were randomized to Stage 2 and received at least 1 dose of study medication during Stage 2 and had at least 1 post-baseline (Stage 2) efficacy assessment in Stage 2.||mg/dL||Standard Deviation|Least Squares Mean
49824|NCT01324102|Primary|Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.|The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).|Primary outcome is measured at baseline and after the 8 week yoga intervention.|This is a small scale pilot study. Due to small sample size, we did pre-post analysis of the total groups, separated by those with and without initial impairment.||units on a scale||Full Range|Mean
49825|NCT01323998|Primary|Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis|The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.|4 years|Males aged 50 and older with a new pharmacy claim for AB, 5ARI or a combination of both. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram, or a procedure code for prostate surgery.||participants|||Number
49826|NCT01323920|Secondary|The Cumulative Incidence of Chronic GVHD Requiring Systemic Immune Suppression up to 1 Year After Stem Cell Infusion||2 years|||percent|||Number
49827|NCT01323920|Secondary|The Non-relapse Mortality, Progression-free and Overall Survival up to 1 Year After Stem Cell Infusion|Progression free and overall survival by 1 year after stem cell infusion will be assessed using the method of Kaplan and Meier. Progression-free survival will be defined as the time from stem cell infusion to the time of disease progression or death from any cause. Overall survival will be defined as the time from stem cell infusion to the time to death from any cause. Patients will be censored at the time last documented alive. Cumulative incidence and Kaplan-Meier curves will be constructed as appropriate.|2 years|||percent|||Number
49828|NCT01323920|Secondary|The Percentage Donor Engraftment up to Day 30 Post Stem Cell Infusion|To assess the percentage donor engraftment up to day 30 post stem cell infusion, defined as the first of 3 consecutive days tested of documented absolute netrophil count (ANC) >/= 500 cells/u/L|2 years|||percent|||Number
49829|NCT01323920|Primary|Cumulative Incidence of Grade II-IV Acute GVHD up to Day 100 After Stem Cell Infusion||2 years|||percentage of participants|||Number
49830|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with mild CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with mild CRI are presented, participants with severe or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure||ng.hr/mL||95% Confidence Interval|Geometric Mean
49831|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with moderate CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with moderate CRI are presented, participants with mild or severe CRI or their corresponding healthy matched controls were not analyzed in this outcome measure||ng.hr/mL||95% Confidence Interval|Geometric Mean
49832|NCT01323855|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|Four participants with severe CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with severe CRI are presented, participants with mild or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure||ng.hr/mL||95% Confidence Interval|Geometric Mean
49833|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
49834|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
49835|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue – First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||hours||95% Confidence Interval|Median
49836|NCT01323790|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of SBMs/week||Standard Error|Least Squares Mean
49837|NCT01323790|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: “Did you feel like your bowels were completely empty after the bowel movement?” Patients provided a yes or a no response. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Percent days/week||Standard Error|Least Squares Mean
49838|NCT01323790|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
49839|NCT01323790|Secondary|Change From Baseline in Degree of Straining|A single-item straining question was asked via the eDiary: “How much did you strain during your bowel movement?” Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
49840|NCT01323790|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of Days||Standard Error|Least Squares Mean
49841|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Hours||95% Confidence Interval|Median
49842|NCT01323790|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.||Number of patients|||Number
49843|NCT01323790|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of patients|||Number
49844|NCT01323673|Secondary|Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15|On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Percent change in scores on a scale||Standard Deviation|Mean
49845|NCT01323673|Secondary|Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
49846|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
49847|NCT01323673|Secondary|Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
49848|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
49849|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
49850|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
49865|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50. This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
49851|NCT01323673|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|Intent-to-Treat (ITT) Population: all randomized participants who were dispensed study product. Missing values were imputed using last observation carried forward (LOCF, i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).||participants|||Number
49852|NCT01323660|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49853|NCT01323660|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 1.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49854|NCT01323660|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49855|NCT01323660|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49866|NCT01323634|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.||Minutes||Full Range|Median
50090|NCT01319500|Primary|"Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons"|"Non-contraceptive reasons for OC prescriptions (including both categories: contraception plus non-contraceptive reasons and non-contraceptive reasons only"|February 2009 - March 2009|||number of participants|||Number
49856|NCT01323660|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Liters||Standard Error|Least Squares Mean
49857|NCT01323660|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.||Seconds||Standard Error|Least Squares Mean
49858|NCT01323647|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (Day 0 to Month 01).|The Total Cohort, including all subjects enrolled in the study.||Subjects|||Number
49859|NCT01323647|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.|Within the 31-day follow-up period after the Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.||Subjects|||Number
49860|NCT01323647|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥37.0°C). Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Grade 3 drowsiness was defined as drowsiness that prevents normal activities. Grade 3 fever was defined as fever (axillary temperature) >39.0°C. Grade 3 irritability was defined as crying more than usual/ interferes with normal activities. Grade 3 loss of appetite was defined as not eating at all. Related = symptom assessed by the investigator as related to the vaccination. This outcome measure concerns subjects only in the Poliorix Group.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.||Subjects|||Number
49861|NCT01323647|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.||Subjects|||Number
49862|NCT01323647|Primary|Antibody Titres Against Poliovirus Type 1, 2 and 3.|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.|Before booster vaccination.|The ATP cohort for antibody persistence included all subjects who completed their full 3-dose primary vaccination course in the primary study and who have not received an additional dose of IPV vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results are available at the persistence timepoint||Titres||95% Confidence Interval|Geometric Mean
49863|NCT01323647|Primary|Antibody Titres Against Poliovirus Type 1, 2 and 3|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.||Titres||95% Confidence Interval|Geometric Mean
49864|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.|Before booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
49867|NCT01323634|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
49868|NCT01323621|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Baseline and Day 1|ITT Population||Minutes||Full Range|Median
49869|NCT01323621|Primary|Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
49870|NCT01323595|Secondary|Bleeding Complications|We will record whether there are any bleeding complications associated with treatment after surgery.|7 days after surgery||||||
49871|NCT01323595|Primary|Level of Pain|Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale (0= no pain, 10=worst pain ever). Patients are asked to rate their pain up to four times a day during the post-operative period. Pain scores from each post-operative day each day will be averaged and reported as the pain score for that day.|1 week after surgery|||Analog pain scale||Standard Deviation|Mean
49872|NCT01323582|Secondary|Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms are. The scale is reported in the references.~This is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change."|Baseline and end of treatment period|||units on a scale||Standard Deviation|Median
49873|NCT01323582|Secondary|Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score.~Negative value reflects this change."|Baseline and end of treatment period|One subject did not complete this part of analysis.||units on a scale||Standard Deviation|Mean
49874|NCT01323582|Secondary|Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|at baseline before initiation of the treatment and after completion of each treatment period.|||minutes||Standard Deviation|Mean
49875|NCT01323582|Secondary|Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|Baseline and end of treatment period|||Minutes||Standard Deviation|Mean
49876|NCT01323582|Secondary|TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)|This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)|||Minutes||Standard Deviation|Mean
49877|NCT01323582|Secondary|NDI Score|"Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50).~For the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life.~Reference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)|||units on a scale||Standard Deviation|Median
49893|NCT01323270|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level||1 month after Vaccination 3|||percentage of participants|||Number
49894|NCT01323270|Secondary|Geometric Mean Titer (GMT) for Poliomyelitis Antigens||1 month after Vaccination 1|||titer||95% Confidence Interval|Geometric Mean
49895|NCT01323270|Secondary|GMC for Acellular Pertussis Antigens|Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)|1 month after Vaccination 1|||EU/mL||95% Confidence Interval|Geometric Mean
49878|NCT01323582|Primary|Gastroparesis Cardinal Symptom Index (GCSI) Score|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms.~Reference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)|One subject did not complete this part of analysis.||units on a scale||Standard Deviation|Mean
49879|NCT01323582|Primary|Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)|||Minutes||Standard Deviation|Mean
49880|NCT01323478|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.|Up to 52 weeks|Suicidal Ideation and Behaviour Based on C-SSRS Scores by Columbia Classification Algorithm for Suicide Assessment (C-CASA) - APTS||participants|||Number
49881|NCT01323478|Secondary|ASEX Total Score After 52 Weeks of Treatment|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Week 52|APTS, OC||units on a scale||Standard Error|Mean
49882|NCT01323478|Secondary|SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 52|FAS, OC||units on a scale||Standard Deviation|Mean
49883|NCT01323478|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Baseline and Week 52|FAS, OC||percentage of patients|||Number
49884|NCT01323478|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Baseline from lead-in study 13267A (NCT01140906) and Week 52|FAS, OC||percentage of patients|||Number
49885|NCT01323478|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS, OC||units on a scale||Standard Deviation|Mean
49886|NCT01323478|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS, OC||units on a scale||Standard Deviation|Mean
49887|NCT01323478|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|full-analysis set (FAS), observed cases (OC)||units on a scale||Standard Deviation|Mean
49888|NCT01323478|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS||percentage of patients|||Number
49889|NCT01323478|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|all-patients-treated set (APTS)||participants|||Number
49890|NCT01323270|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|Summary was performed for participants as per vaccine administration.||percentage of participants|||Number
49891|NCT01323270|Other Pre-specified|Geometric Mean Fold-Rise (GMFR) for IgG||Before Vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.|||||
49892|NCT01323270|Other Pre-specified|Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT)||Before vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.|||||
49898|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores|"Q-LES-Q-SF is a 16-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 16 items. The raw total score is transformed into a percentage maximum possible score using the following formula:(raw total score −minimum score) / (maximum possible raw score −minimum score). The minimum raw score on the Q-LES-Q-SF is 16 (worst), and the maximum score is 80 (best). A higher score indicates a better quality of life."|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Standard Deviation|Mean
49899|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales–Self Report: Screening Version (CAARS-S:SV) Score|CAARS-S:SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-S:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Standard Deviation|Mean
49900|NCT01323192|Secondary|Clinical Global Impression of Change (CGI-C) Scores|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Full Range|Median
49901|NCT01323192|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Full Range|Median
49902|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O: SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment.||Scores on a scale||Standard Deviation|Mean
49903|NCT01323192|Primary|Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.||Scores on a scale||Standard Deviation|Mean
49904|NCT01323140|Primary|Percent of Subjects With Testosterone Levels in the Normal Range.|Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (>= 300 ng/dL to <= 1030 ng/dL), at least 85% of subjects with Cmax <= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax >= 2500 ng/dL.|Day 29/30|||percentage of participants||95% Confidence Interval|Number
49905|NCT01323010|Secondary|Admission Rates in Patients With the Arg16Gly Polymorphisms|Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes).|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|The sequencing of the beta-2 adrenergic receptor gene was performed in a subset of 60 patients, in the other samples these analysis were not feasible due to hemolysis.||participants|||Number
49906|NCT01323010|Secondary|Admission Rates in Patients With and Without Rhinovirus Detect|Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.||percentage of participants|||Number
49951|NCT01322594|Primary|Incidence of Clinically Significant Electrocardiogram Results|Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
49907|NCT01323010|Secondary|Admission Rates in Patients With and Without Any Virus Detected|Admission rates in patients with and without any of the following viruses detected by PCR in nasal lavage samples: Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza (A H3N2, A H1N1/2009, B and C); Metapneumovirus (subtypes A and B); Parainfluenza 1, 2, 3 and 4 (subtypes A and B); Rhinovirus; Respiratory Syncytial Virus type A and Respiratory Syncytial Virus type B.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.||percentage of participants|||Number
49908|NCT01323010|Secondary|Lengths of Stay in the Emergency Room|lengths of stay in the emergency room for discharged patients|one to four hours|||hours||Inter-Quartile Range|Median
49909|NCT01323010|Secondary|Electrocardiogram at Discharge or Hospital Admission|Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|No electrocardiographic abnormalities were detected in both groups.||participants with ECG abnormalities|||Number
49910|NCT01323010|Secondary|Electrocardiogram One Hour Post-treatment.|Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.|One hour post-treatment|No electrocardiographic abnormalities were detected im both groups||participants with ECG abnormalities|||Number
49911|NCT01323010|Secondary|Changes in Heart Rate at Discharge or Hospital Admission|Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|||beats per minute||Standard Error|Mean
49912|NCT01323010|Secondary|Changes in Heart Rate After One Hour|Change in heart rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline|||beats per minute||Standard Error|Mean
49913|NCT01323010|Secondary|Changes in Pulse Oximetry at Discharge or Hospital Admission.|Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|||percentage of oxygen saturation||Standard Deviation|Mean
49914|NCT01323010|Secondary|Change in Pulse Oximetry One Hour Post-treatment|Change in pulse oximetry one hour post-treatment in comparison with baseline|One hour post-treatment in comparison with baseline|||percentage of oxygen saturation||Standard Error|Mean
49915|NCT01323010|Secondary|Changes in Respiratory Rate at at Discharge or Hospital Admission.|Changes in respiratory rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|||breaths per minute||Standard Error|Mean
49916|NCT01323010|Secondary|Changes in Bicarbonate Serum Levels|Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain bicarbonate serum levels from 42 patients in the study group and 37 in the control group (in the other samples, this analysis was not feasible due to the long time to transport the samples to the laboratory in one of our centers).||mmol/L||Standard Error|Mean
49917|NCT01323010|Secondary|Changes in Potassium Serum Levels|Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain potassium serum levels from 54 patients in the study group and 56 in the control group (in the other samples, this analysis was not feasible due to hemolysis).||mEq/L||Standard Error|Mean
49918|NCT01323010|Secondary|Changes in PRAM Score at Discharge or Hospital Admission|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.~The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.~We calculated the difference between the PRAM score measured at discharge or admission and the PRAM score at baseline (PRAM score discharge or admission - PRAM score baseline).~The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).~minimum value of the difference (Albuterol - Higher Dose, experimental group): -9 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0~minimum value of the difference (Albuterol - Lower Dose, control group): -9 maximum value of the difference (Albuterol - Lower Dose, control group): 1"|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|||units on a scale||Inter-Quartile Range|Median
49919|NCT01323010|Secondary|Need for Additional Therapies|The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|no patients received magnesium sulphate or intravenous albuterol in both groups||participants|||Number
49920|NCT01323010|Secondary|Changes in Respiratory Rate After One Hour|Change in respiratory rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline|||breaths per minute||Standard Error|Mean
49921|NCT01323010|Secondary|Electrocardiogram at Baseline|Electrocardiogram performed at baseline|at baseline|no electrocardiopraphic abnormalities were detected in both groups||participants with ECG abnormalities|||Number
49922|NCT01323010|Secondary|Changes in Glucose Serum Levels|Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain glucose serum levels from 57 patients in the study group and 55 in the control group (in the other samples, this analysis was not feasible due to hemolysis).||mg/dL||Standard Error|Mean
49923|NCT01323010|Secondary|Albuterol Determination in the Plasma|Albuterol determination in the plasma was carried out at at discharge or hospital admission (up to 4 hours post treatment), dosage was accomplished by High Performance Liquid Chromatography.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|It was possible to obtain albuterol plasma levels from 52 patients in the study group and 51 in the control group (in the other samples, this analysis was not feasible due to hemolysis).||ng/ml||Inter-Quartile Range|Median
49924|NCT01323010|Secondary|Change in PRAM Score After One Hour|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score one hour post-treatment in comparison with baseline.~The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.~We calculated the difference between the PRAM score measured one hour post treatment and the PRAM score at baseline (PRAM score 1 hour - PRAM score baseline).~The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).~minimum value of the difference (Albuterol - Higher Dose, experimental group): -8 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0~minimum value of the difference (Albuterol - Lower Dose, control group): -8 maximum value of the difference (Albuterol - Lower Dose, control group): 0"|One hour post-treatment|||units on a scale||Inter-Quartile Range|Mean
49925|NCT01323010|Secondary|Forced Expiratory Volume in the First Second|Change in FEV1 one hour post-treatment in comparison with baseline. Spirometry was performed only in subjects older than 6 years and who could perform the maneuver properly.|One hour post-treatment in comparison with baseline|||percentage of predicted||Standard Deviation|Mean
49926|NCT01323010|Primary|Hospital Admission|Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%)|Starting at 4 hours post-treatment|||participants|||Number
49927|NCT01322971|Secondary|Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)||up to 2 years|No data were collected for this outcome|||||
49928|NCT01322971|Secondary|Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)||up to 2 years|No data were collected for this outcome|||||
49929|NCT01322971|Secondary|Pregnancy Rate (Pregnancy Visible on Ultrasound)||up to 2 years|No data were collected for this outcome|||||
49930|NCT01322971|Primary|Biochemical Pregnancy Rate (Positive Pregnancy Test)|Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test|up to 2 years|No data were collected for this outcome|||||
49931|NCT01322945|Secondary|Test-retest Reliability of the ASK Nasal Inventory|First 12 endonasal and 10 control patients enrolled in the study completed the ASK Nasal Inventory at 90 days and 120 days post surgery to measure reliablity of the survey (they scored the 9-item instrument similarly at both time frames)comparing 5-point Likert scale scores. Pearson correlation was used to determine a correlation between each patient's responses at 90 days post op and 120 days post op.|90 days and 120 days post surgery|||Correlation Coefficient|||Number
49932|NCT01322945|Primary|Change in Mean Survey Response From Baseline to 90 Days Post Surgery|Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.|Baseline, 90 days post surgery|Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.||units on a scale||Standard Deviation|Mean
49933|NCT01322841|Secondary|Percentage of Patients Diagnosed With One of the Disorders||six months|||percentage of participants|||Number
49934|NCT01322841|Primary|Percentage of Patients Screened Positive for One of the Disorders||six months|||percentage of participants|||Number
49935|NCT01322815|Primary|Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)|Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.|4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patients|Patients with RAS mutant positive metastatic colorectal cancer (CRC), either newly diagnosed, or having completed first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen.||participants|||Number
49936|NCT01322633|Secondary|Incidence Rate of Overall Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.||incidence per 100000 person-years||95% Confidence Interval|Number
49952|NCT01322594|Primary|Incidence of Clinically Significant Hematology Laboratory Results|Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
49953|NCT01322594|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
49954|NCT01322594|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis||Participants|||Number
49937|NCT01322633|Secondary|Incidence Rate of Composite Gastrointestinal Cancers|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.||incidence per 100000 person-years||95% Confidence Interval|Number
49938|NCT01322633|Primary|Incidence Rate of Gastric Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.||incidence per 100000 person-years||95% Confidence Interval|Number
49939|NCT01322607|Secondary|Balance|Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).|3 months|||units on a scale||Standard Deviation|Mean
49940|NCT01322607|Secondary|Muscular Endurance|Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.|3 months|||seconds||Standard Deviation|Mean
49941|NCT01322607|Secondary|Muscular Strength|Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.|3 months|||newtons (N)||Standard Deviation|Mean
49942|NCT01322607|Primary|Economy of Gait|Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.|3 months|||ml/kg/min||Standard Deviation|Mean
49943|NCT01322594|Secondary|Clearance (CL)|CL of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||L/Days||Standard Deviation|Mean
49944|NCT01322594|Secondary|Apparent Terminal Elimination Phase Half-life (t1/2)|t1/2 of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||Days||Standard Deviation|Mean
49945|NCT01322594|Secondary|Observed Maximum Concentration (Cmax)|Cmax of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||ng/mL||Standard Deviation|Mean
49946|NCT01322594|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI2338|Number of participants with ADA to MEDI2338|Days 1, 57, and 92|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA||Participants|||Number
49947|NCT01322594|Secondary|Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point|Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||ng x day/mL||Standard Deviation|Mean
49948|NCT01322594|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinity|Area under the serum concentration-time curve from time zerio to infinity of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis||ng x day/mL||Standard Deviation|Mean
49955|NCT01322386|Primary|Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia|Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia through improvement of Liver function tests (LFTs) within 3 months of initiating therapy. In addition for PSC, we looked at 25% reduction of abnormal ALT & GGT, reduction in biliary strictures and beading, and reduction of inflammation in liver biopsies and colon biopsies.|Within 3 months of therapy|Ten BA participants had surgery (Kasai portoenterostomyprocedure) at 1 week before starting the Vancomycin so we could not determine if they benefited from the therapy. On oral vancomycin, 9 PSC patients had improvement of LFTs, 8 had improvement of liver biopsies and/or MRI, and colon biopsies,and 1 pt. refused to have these additional studies.||participants|||Number
49956|NCT01322360|Secondary|Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade|Subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade|Up to 21 days|||participants|||Number
49957|NCT01322360|Primary|Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation|"The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade.~Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator."|Up to 21 days|75 subjects were screened and 50 subjects took at least one dose of oral morphine sulfate.||participants|||Number
49958|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.||grams per liter||Standard Deviation|Mean
49959|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
49960|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.||grams per liter per week||Standard Deviation|Mean
49961|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||percentage||Standard Deviation|Mean
49962|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
49963|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||micrograms per liter||Standard Deviation|Mean
49964|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||picograms||Standard Deviation|Mean
49965|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
49966|NCT01322347|Secondary|Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percentage of change from baseline||Standard Deviation|Mean
49980|NCT01321749|Secondary|The Time Point Until the First Stroke Recurrence,|These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.|At the 300-day after the initial treatment||||||
49981|NCT01321749|Primary|Number of Patients Who Got New Brain Lesions|We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)|300 days after treatment|||participants|||Number
49967|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects||units of red blood cells or whole blood|||Number
49968|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects||participants|||Number
49969|NCT01322347|Secondary|Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromole per liter||Standard Deviation|Mean
49970|NCT01322347|Secondary|Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percent||Standard Deviation|Mean
49971|NCT01322347|Secondary|Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
49972|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.||grams per liter||Standard Error|Least Squares Mean
49973|NCT01322022|Primary|Actigraphy - Sleep Latency|Measure of sleep latency defined by the time from lights off to sleep onset.|Baseline, Week 4, Week 8|||minutes||Standard Deviation|Mean
49974|NCT01322022|Primary|Actigraphy - Sleep Efficiency|Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off|Baseline, Week 4, Week 8|||Percentage of Time Sleeping||Standard Deviation|Mean
49975|NCT01322022|Secondary|Actigraphy - Total Sleep Time|Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.|Baseline, Week 4, Week 8|||minutes||Standard Deviation|Mean
49976|NCT01322022|Primary|Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index|The MSPSQ used by Wiggs and colleagues (Wiggs & Stores, 1996 ; Wiggs & Stores, 1999 : Wiggs & Stores, 2004) was used to assess the child's sleep quality. It was completed by the primary caregiver for both groups at baseline and at weeks 4 and 8. Using Wiggs & Stores earlier-described conventions for determining the Composite Sleep Index (CSI) score, the CSI was calculated by assigning a score to the frequency of the targeted sleep problems: bedtime resistance, night awakening, early awakening, and sleeping in places other than bed. In addition, scores were assigned for the duration of sleep latency and night awakenings. The total CSI score ranged from 0 to 12, with higher scores indicating more severe bedtime and sleep patterns.|Baseline, Week 4, and Week 8|||units on a scale||Standard Deviation|Mean
49977|NCT01322009|Secondary|Antioxidant Reserve|Antioxidant reserves in CSF and serum will be calculated in both treatment arms and compared.|Within 5 days of injury|||reactive oxygen species scavenged||Standard Error|Mean
49978|NCT01322009|Primary|Number of Participants Who Experienced Adverse Events|"The number of patients experiencing one or more of the following adverse events:~Acute renal failure Anaphylaxis Acute respiratory distress syndrome Intracranial infection/abscess Arrhythmia, atrial Arrhythmia, ventricular Bradycardia Cardiac arrest Catheter positive culture Cerebrospinal fluid leak Decubitis Deep vein thrombosis Diabetes Insipidus Emesis Extraaxial hematoma Gastrointestinal bleed Gastritis Hematuria Hemorrhage, other Hemoperitonium Hemothorax Hepatitis Hydrocephalus Hypotension Hypoxemia Infection, other Intraparenchymal hemorrhage Intraventricular hemorrhage Meningitis/ventriculitis Multiorgan dysfunction syndrome Myocardial ischemia Pancreatitis Pericarditis Peritonitis Pneumothorax Pulmonary edema Pulmonary embolism Respiratory arrest Seizures Sepsis Syndrome of inappropriate antidiuretic hormone Transtentorial herniation Withdrawal of Life Support Other SAE causing re-hospitalization Other SAE"|14 days after drug administration|||participants|||Number
49979|NCT01321749|Secondary|Brain Perfusion Improvement Are Evaluated With SPECT and TCD|Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection.|300-day after treatment||||||
49984|NCT01321723|Secondary|% Change From Baseline in Bone Formation Marker (P1NP) at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.||percentage of change||Standard Deviation|Mean
49985|NCT01321723|Secondary|Systemic Absorption of PTH at Week 24|AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)|24 weeks|||pg* hr/mL||Standard Deviation|Mean
49986|NCT01321723|Secondary|% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24|Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.|24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.||percentage of change||Standard Deviation|Mean
49987|NCT01321723|Post-Hoc|Number of Participants With AEs as a Measure of Safety and Tolerability||24 weeks|Overall Summary of Adverse Events - Each subject with an event is counted only once although they may have several events.||participants|||Number
49988|NCT01321723|Primary|% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.||percentage of change||Standard Deviation|Mean
49989|NCT01321710|Primary|Change in Infant Sleep Quantity (Objective)|Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.|24 hours before and 24 hours after immunizations at approximately 2 months of age|ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis.||minutes||Standard Deviation|Mean
49990|NCT01321710|Secondary|Maternal Well-being|Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.|1 month postpartum (approximately)|ITT analysis.||Scores on a scale||Standard Deviation|Mean
49991|NCT01321710|Secondary|Maternal Sleep Disturbance (Subjective)|Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.|1 month postpartum (approximately)|ITT analysis.||Scores on a scale||Standard Deviation|Mean
49992|NCT01321710|Primary|Maternal Sleep Quality (Objective)|Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.|1 month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.||percentage of sleep per time in bed||Standard Deviation|Mean
49993|NCT01321710|Primary|Maternal Sleep Quantity (Objective)|Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.|1-month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.||hours||Standard Deviation|Mean
49994|NCT01321697|Primary|Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.||at time of surgery|Data were not collected/analyzed due to study termination.|||||
49995|NCT01321554|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded independent imaging review (IIR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set (Intent-to-Treat Analysis Set) included all randomized subjects.||months||95% Confidence Interval|Median
49996|NCT01321554|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve|AUC was used to determine the total exposure of lenvatinib in blood plasma. From each participant, a total of up to 12 blood samples were collected at the following specified time points: predose, 0.5 to 4 hours postdose, and 6 to 10 hours postdose on Cycle 1/Day 1 and Cycle 1/Day 15; predose and 2 to 12 hours postdose on Cycle 2/Day 1; and predose only on Day 1 of Cycles 3 to 6. The samples were analyzed for the concentration of lenvatinib using validated analytical methods. Population PK model and observed concentration data were used to derive model-predicted lenvatinib PK parameters and lenvatinib exposure (AUC) based on the 24 mg starting dose.|Cycle 1 Day 1 through Cycle 6 Day 1|PK Analysis Set - All the subjects who received at least one dose of study drug and had evaluable PK data||ng*h/mL||Full Range|Median
49997|NCT01321554|Secondary|Overall Survival (OS)|Overall survival measured from the date of randomization until date of death from any cause. Overall survival is adjusted with rank preserving structural failure time.|Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set||months||95% Confidence Interval|Median
50012|NCT01320735|Secondary|Median Percentage of Time Off-treatment During 2 Years IAD Regimen|The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.||Percentage of time off-treatment||Full Range|Median
49998|NCT01321554|Secondary|Overall Response Rate (ORR)|ORR, defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by MRI/CT scans (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
49999|NCT01321008|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.|Day 1 to disease progression or death (up to 5+ years)|Study terminated early, no analysis available.|||||
50000|NCT01320826|Primary|Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."|[When pathology from colonoscopy available (on average 2-3 weeks after procedure)]|For this outcome, we only examined females ≥ 50 years old having their first colonoscopy||percentage of females||95% Confidence Interval|Mean
50001|NCT01320826|Secondary|Percentage of Patients Referred to a Specialist.|The percentage of patients who are anticipated to be referred to specialists, for the gastrointestinal complaint for which the colonoscopy was performed will be determined and the reason for referral will be tabulated. The referral percentage will be determined both from the time of colonoscopy (physician reported) and from the patient satisfaction phone survey (patient reported).|Within four (4) weeks of colonoscopy|||percentage of patients|||Number
50002|NCT01320826|Secondary|Colonoscopy Procedure Time|Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.|At time of colonoscopy (DAY 1 of study)|||minutes||95% Confidence Interval|Mean
50003|NCT01320826|Secondary|Patient Satisfaction With Hospital Experience for Colonoscopy|"Patient satisfaction with their hospital experience during their colonoscopy will be recorded by using a 7 point Likert scale at the time of the patient satisfaction phone survey.~7 = extremely satisfied~1 = extremely dissatisfied~Minimum score = 1 Maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients consented to and completed the post procedural satisfaction survey.||units on a scale||Inter-Quartile Range|Median
50004|NCT01320826|Secondary|Patient Satisfaction With Endoscopy Wait Time|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied~minimum score = 1 maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients completed the post procedural satisfaction survey.||units on a scale||Inter-Quartile Range|Median
50005|NCT01320826|Secondary|Patient Comfort During Colonoscopy|"To determine the patients' comfort level during the colonoscopy, a five-item question used by the Joint Advisory Group on Gastrointestinal Endoscopy in the United Kingdom will be used.~Patient discomfort on the 5 point scale:~0 is no discomfort;~is one or two episodes of discomfort, well tolerated;~is more than two episodes of discomfort adequately tolerated;~is significant discomfort experienced several times during the procedure;~is extreme discomfort experienced frequency throughout the procedure.~Minimum value = 0, maximum value = 4 with 4 being worse."|At time of colonoscopy (DAY 1 of study)|||units on the scale||Standard Deviation|Mean
50006|NCT01320826|Secondary|Colonoscopy Withdraw Time in Cases Where no Lesions Found|Withdrawal time will be defined as the time from leaving the cecum until the colonoscope exits the anus. This will be calculated for cases in which no lesions were found.|At time of colonoscopy (DAY 1 of study)|Only examined patients in which no lesions were detected.||minutes||95% Confidence Interval|Mean
50007|NCT01320826|Secondary|Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.~Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).~All potential serious complications of colonoscopy will be externally adjudicated."|Within four (4) weeks of colonoscopy|||patients undergoing colonoscopy|||Number
50008|NCT01320826|Primary|Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|We only examined this outcome for males 50 years and older having their first colonoscopy||percentage of males||95% Confidence Interval|Mean
50009|NCT01320826|Primary|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|Number of patients who underwent colonoscopy||adenomas / colonoscopy||95% Confidence Interval|Number
50010|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Adjusted)|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)|At time of colonoscopy (DAY 1 of study)|||percentage of colonoscopies attempted||95% Confidence Interval|Number
50011|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100|At time of colonoscopy (DAY 1 of study)|Prospective, observational study, all study participants were analyzed||percentage of colonoscopies performed||95% Confidence Interval|Number
50014|NCT01320735|Secondary|Mean Duration of Treatment-off Time in IAD Regimen|Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin [cycle N+1] minus last dose date [cycle N] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.||Months||Standard Deviation|Mean
50015|NCT01320735|Primary|Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen|The data are reported as percentage of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Percentage of participants|||Number
50016|NCT01320735|Other Pre-specified|Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.||Participants|||Number
50017|NCT01320735|Other Pre-specified|Number of Participants Who Received IAD Regimen During the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.||Participants|||Number
50018|NCT01320735|Secondary|Median Survival Time|Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Participants who died while on study were used for analysis.||Months||Full Range|Median
50019|NCT01320735|Secondary|Median Time to Progression of HRPC in Participants Not Started on IAD Regimen|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements of participants who did not start on IAD regimen.||Months||95% Confidence Interval|Median
50020|NCT01320735|Secondary|Median Time to Progression of HRPC|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.||Months||Full Range|Median
50021|NCT01320735|Primary|Median Number of Leuprorelin Cycles|The Participants were on IAD regimen and the data are reported as number of cycles with full range.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. However, one participant started continuous hormone therapy and was not included in the analysis.||Cycles||Full Range|Median
50022|NCT01320735|Secondary|Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)|Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.||Participants|||Number
50023|NCT01320735|Primary|Mean Duration of Each Leuprorelin Cycle|Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Months||Standard Deviation|Mean
50024|NCT01320735|Primary|Mean Duration of Leuprorelin Exposure|Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.||Months||Standard Deviation|Mean
50025|NCT01320735|Other Pre-specified|Duration of IAD Regimen Induction Phase|Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.|At least 6-9 months after Baseline (enrollment)|Data are of measurements collected from participants who started IAD.||Months||Standard Deviation|Mean
50026|NCT01320683|Secondary|Overall Survival|Overall Survival is calculated for all patients from the date of initial treatment to date of death due to any cause. Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method, and 95% confidence limits calculated for these estimates.|Up to 5 years||||||
50027|NCT01320683|Primary|Progression-free Survival|"Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 24 months||||||
50091|NCT01319500|Primary|Reasons for OC Prescriptions|The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.|February 2009 - March 2009|||percentage of participants||95% Confidence Interval|Number
50028|NCT01320553|Secondary|Ciliary Redness Evaluated by the Investigator|Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed.|Up to 4 weeks|||units on a scale||Standard Deviation|Mean
50029|NCT01320553|Primary|Ocular Itching|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.|Up to 28 days|"Of the 122 subjects enrolled in the study, a total of 8 subjects did not complete the study: 1 in the 1334H 0.15% group, 4 in the 1334H 0.3% group, 2 in the 1334H 0.45% group and 1 in the vehicle treated group.~The Per Protocol population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects."||units on a scale||Standard Deviation|Mean
50030|NCT01320293|Secondary|Changes in Adiponectin Profile Compared to Baseline|Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.|24 weeks|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.||pg/ml||95% Confidence Interval|Mean
50031|NCT01320293|Secondary|Changes in IL-6 Profile Compared to Baseline|IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.||pg/ml||95% Confidence Interval|Mean
50032|NCT01320293|Primary|Percentage Change in Endothelial Function Compared to Baseline.|Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.||percent change||95% Confidence Interval|Mean
50033|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized patients who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
50034|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
50035|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.||grams per liter per week||Standard Deviation|Mean
50036|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percentage of saturation||Standard Deviation|Mean
50037|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||grams per liter||Standard Deviation|Mean
50038|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micrograms per liter||Standard Deviation|Mean
50039|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||picograms||Standard Deviation|Mean
50040|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
50092|NCT01319500|Primary|OC Prescriptions by Treatment Group and Prescribing Medical Specialists|Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)|February 2009 - March 2009|||Prescribing physicians|||Number
50183|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50041|NCT01320202|Secondary|Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||percentage of change||Standard Deviation|Mean
50042|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.||units of red blood cells or whole blood|||Number
50043|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.||participants|||Number
50044|NCT01320202|Secondary|Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromole per liter||Standard Deviation|Mean
50045|NCT01320202|Secondary|Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to treat: all randomized subjects who had at least one dose of study drug and had at least one post-dose hemoglobin measured.||percent||Standard Deviation|Mean
50046|NCT01320202|Secondary|Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat population: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.||micromoles per liter||Standard Deviation|Mean
50047|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained.||grams per liter||Standard Error|Least Squares Mean
50048|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition|Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
50049|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)|Responders are defined as subjects with a concentration after Bet v 1 stimulation above P95 (determined on Bet v 1 BrdU+ subjects) of all concentrations after medium only stimulation|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
50050|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition|"Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays.~Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation."|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
50184|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50051|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines|"Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays.~Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation"|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.||Subjects|||Number
50052|NCT01320072|Secondary|Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients|We will assess FEV1% change from baseline at 12 months in AERD patients who have been on aspirin treatment for 12 months (current standard of care)|12 months|AERD patients will continue aspirin treatment for 12 months and the change from baseline in their FEV1% predicted will be monitored during this time||change in percent predicted FEV1||Standard Error|Mean
50053|NCT01320072|Secondary|Treatment-Related Adverse Events|Adverse reactions defined as bronchospasm requiring endotracheal intubation. The adverse reactions will be assessed through a post challenge follow-up with the patient at baseline and 24 hours after the challenge|24 hours after the challenge|||participants|||Number
50054|NCT01320072|Primary|Eicosanoid Metabolites Concentration|eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge|2 hours|||log-pg/mg creatinine||Standard Error|Mean
50055|NCT01319877|Secondary|Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.|Up to 36 Months|Evaluable participants.||score on a scale||Standard Deviation|Mean
50056|NCT01319877|Secondary|One-year Survival Rate by the Chemotherapy Regimen Subgroup||1 year|Participants with known prior chemotherapy regimens were evaluated||percentage of participants||95% Confidence Interval|Number
50057|NCT01319877|Secondary|One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.|1 year|Participants with known prior chemotherapy regimens were evaluated.||percentage of participants||95% Confidence Interval|Number
50058|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.|Up to 36 Months|Participants with known prior chemotherapy regimens were evaluated||percentage of participants||95% Confidence Interval|Number
50059|NCT01319877|Secondary|One-year Survival Rate by the KRAS Subgroup||1 year|Participants with known KRAS status were evaluated||percentage of participants||95% Confidence Interval|Number
50060|NCT01319877|Secondary|One-year Progression-free Survival Rate Per KRAS Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|1 year|Participants with known KRAS status were evaluated.||percentage of participants||95% Confidence Interval|Number
50061|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|36 months|Participants with known KRAS status were evaluated.||percentage of participants||95% Confidence Interval|Number
50062|NCT01319877|Secondary|One-year Survival Rate||1 year|||percentage of participants||95% Confidence Interval|Number
50063|NCT01319877|Secondary|One-year Progression-free Survival Rate|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.|1 year|||percentage of participants||95% Confidence Interval|Number
50064|NCT01319877|Secondary|Progression-free Survival|Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.|36 months|||months||95% Confidence Interval|Median
50065|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.|36 months|||percentage of participants||95% Confidence Interval|Number
50066|NCT01319877|Primary|Percentage of Participants With Bevacizumab-related Serious Adverse Events||36 months|||percentage of participants|||Number
50067|NCT01319877|Primary|Percentage of Participants With Bevacizumab-Related Adverse Events||36 months|||percentage of participants|||Number
50068|NCT01319877|Primary|Percentage of Participants With Adverse Events of Special Interest||36 months|||percentage of participants|||Number
50069|NCT01319877|Primary|Percentage of Participants With Serious Adverse Events|A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.|36 months|||percentage of participants|||Number
50071|NCT01319851|Secondary|Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)|The severity criteria of chronic graft-versus-host disease (cGVHD) recommended by the NIH Criteria Consensus (NCC) was employed. The number of organs involved and the severity of the disease in these organs dictated the global summary score used to define the disease as mild, moderate, or severe. Mild disease indicates one or two organs involved each with a maximal score of 1. Moderate disease indicates three or more organs involved with a score of 2 in any individual organ, or lung involvement with a score of 1. Severe global GVHD is defined by a score of 3 in any organ, or a lung score of 2.|Day 100 post-transplant|||participants|||Number
50072|NCT01319851|Secondary|Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV|Cumulative Incidence of Grade II-IV aGVHD Score at 30 Days. The NIH Consensus grading and severity criteria includes physical assessments of skin, oral cavity, eyes, gynecological and laboratory data and patient reports. Each domain is scored from Grade 0 (no involvement) to Grade IV (severe involvement).|Day 30 post-transplant|||participants|||Number
50073|NCT01319851|Secondary|Incidence of 100% CD33 Donor Chimerism|CD33 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant|||participants|||Number
50074|NCT01319851|Secondary|Incidence of Greater Than or Equal to 85% CD3 Donor Chimerism|CD3 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant|||participants|||Number
50075|NCT01319851|Secondary|Number of Participants That Expressed Successful Neutrophil Engraftment|Neutrophil engraftment was assessed with absolute neutrophils >500*10^8/kg by 100 days post transplant. Neutrophils were counted by performing a complete blood cell count (CBC).|Day 100 post-transplant|||participants|||Number
50076|NCT01319851|Secondary|Number of Participants That Expressed Grade 2 or 3 Regimen-Related Toxicity|Regimen-related toxicity was measured using the Bearman criteria. The Bearman criteria grades toxicity levels at Grade 1, Grade 2, Grade 3, and Grade 4. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. All regimen-related toxicities were determined to be unlikely attributable to the study drug.|Day 42 post-transplant|||participants|||Number
50077|NCT01319851|Primary|Feasibility of Alefacept Pre-conditioning, Measured by Number of Subjects With Full Donor Engraftment|All subjects received alefacept prior to hematopoietic stem cell transplantation and were followed up to at least two years after transplantation to ensure successful engraftment.|Two years post-transplant|||participants|||Number
50078|NCT01319773|Secondary|Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1|Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).|Day 1|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.||Number of Eyes|Participants||Number
50079|NCT01319773|Secondary|Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)|Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).|3 Days|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.||Number of Subjects|||Number
50080|NCT01319773|Primary|Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)|Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.|Day 1|Safety Population: All randomized subjects who were treated with at least 1 dose of study medication.||Nanogram/milliliter (ng/mL)|||Number
50081|NCT01319721|Secondary|Postoperative Conjunctival Inflammation|The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe).|One month|||eyes|Participants||Number
50082|NCT01319721|Secondary|Eye Movement Amplitude (EMA)||One Year|||millimeter|Participants|Standard Deviation|Mean
50083|NCT01319721|Secondary|Healing Time of Corneal Epithelial Defect||Four Weeks|||days|Participants|Standard Deviation|Mean
50084|NCT01319721|Secondary|Complications||One year|||eyes|Participants||Number
50085|NCT01319721|Primary|Recurrence|Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea.|One Year|||eyes|Participants||Number
50086|NCT01319617|Primary|Ocular Discomfort|Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.|After 24 hours of device wear|||mm||Standard Deviation|Mean
50087|NCT01319552|Primary|Measure of Non-transferrin-bound Iron|"Comparison of increase in non-transferrin-bound iron for each participant between his or her fresh and old blood transfusion four hours after transfusion."|four hours after transfusion|||μM||Standard Deviation|Mean
50088|NCT01319500|Primary|Reasons for OC Prescriptions by Gynecologists and Dermatologists||February 2009 - March 2009|||number of participants|||Number
50089|NCT01319500|Primary|Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)|"Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category non-contraceptive reasons only"|February 2009 - March 2009|||number of participants|||Number
50093|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin With Cytokine Profile.|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|The actin polymerization assay that was to be used for this outcome was not reproducible; hence, the cytokine profile of actin polymerized cells could not be pursued. Data were not analyzed.|||||
50094|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin Polymerization With Adverse Effects and Clinical Responses.|Research bone marrow aspirate is obtained to assess response (optional, but recommended), and to document complete remission, if applicable. Correlation to be determined upon completion of study treatment|Research bone marrow aspirate is obtained at baseline and after completion of 2 cycles of therapy (approximately 56 days)|The actin polymerization assay that was to be used for this outcome was not reproducible and data were not analyzed.|||||
50095|NCT01319422|Secondary|To Compare the Effect of Continuous Versus Intermittent Regimens on F Actin Polymerization in Peripheral Blood Mononuclear Cells and Activation of Tumor Antigen-specific T Cells, as Well as Innate Lymphocytes (Natural Killer or Natural Killer T Cells).|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|N/A: data were not collected on this outcome; initial F actin polymerization assay was unreliable and not reproducible; hence, this outcome could not be pursued.|||||
50096|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days).|||percentage of participants|||Number
50097|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|Efficacy assessments will be made after the first two cycles of therapy (approximately 56 days--each cycle is 28 days)|||percentage of participants|||Number
50098|NCT01319396|Primary|Accuracy of Breathing Rate Measurement|accuracy of breathing rate indicated by the BiancaMed BM07 device, compared to that indicated by Somnoscreen to be +/- 5 breaths per minute (95% confidence)|2 minutes|Each participant gives 8 test points, thus with 22+ participants, there are >160 test points, which is sufficient to give a standard deviation.||breaths per minute||Standard Deviation|Mean
50099|NCT01319318|Primary|Percentage of Participants With Vitreous Cell Count of 0|The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (>50 cells) worst.|Week 4|Intent to treat population included all randomized participants.||Percentage of participants|||Number
50100|NCT01319045|Secondary|Quality of Life|Change in quality of life as assessed by SF-36 QOL|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained|||||
50101|NCT01319045|Secondary|Serum Brain Natriuretic Peptide (BNP)|Change in serum BNP level|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained|||||
50102|NCT01319045|Secondary|Exercise Capacity|Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained|||||
50103|NCT01319045|Primary|Safety and Tolerability|Number of Participants with adverse events, specifically mortality and heart failure.|3 months|Number of adverse events.||participants|||Number
50104|NCT01318967|Secondary|Measurement of Regional Blood Oxygenation by MRI|Estimate of renal blood flow by using MRI scans before and after the administration of furosemide|One measure after furosemide (day 1)|||ml/min||Full Range|Mean
50105|NCT01318967|Primary|Measurement of Renal Blood Flow of the Kidney by Both the PAH Method and by MRI|Renal blood flow is estimated by the PAH method.|Renal blood flow is estimated over 1 hour by PAH and 30 minutes by MRI (day 1)|||ml/min||Full Range|Mean
50106|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8 and 29|||participants|||Number
50107|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation||at day 8 and 29|||participants|||Number
50108|NCT01318733|Primary|Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.|"Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema~/ Almost clear; slight redness~/ Mild erythema; definite redness~/ Moderate erythema; marked redness~/ Severe erythema; fiery redness~Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1."|Over 1 year|||scores on a scale||Standard Deviation|Mean
50109|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data||percentage of participants|||Number
50110|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data||percentage of participants|||Number
50111|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks|"Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).~Participants with multiple abnormalities were counted only once in the worst category."|within 48 weeks|Participants in the Safety Set with available data||percentage of participants|||Number
50203|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50112|NCT01318694|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks|"ALT abnormalities were summarized as participants who had either:~ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline~ALT > 3 x ULN during the study and > 2 x ULN at baseline"|within 48 weeks|Participants in the Safety Set, defined as having received at least one dose of study medication, with available data||percentage of participants|||Number
50113|NCT01318694|Secondary|Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks|ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).|at treatment end within 48 weeks|Participants in the Full Analysis Set with available data||percentage of participants|||Number
50114|NCT01318694|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment|eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.|from 4 to 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
50115|NCT01318694|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment|cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
50116|NCT01318694|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment|pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
50117|NCT01318694|Secondary|Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment|EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
50118|NCT01318694|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)|RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.|after 4 weeks of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
50119|NCT01318694|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks after the end of treatment|Participants in the Full Analysis Set with available data||percentage of participants|||Number
50120|NCT01318694|Primary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
50121|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 6|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 10 (Maintenance Period Month 6)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
50122|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 5|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 9 (Maintenance Period Month 5)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
50123|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 8 (Maintenance Period Month 4)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
50124|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 7 (Maintenance Period Month 3)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
50125|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 6 (Maintenance Period Month 2)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
50126|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 1|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 5 (Maintenance Period Month 1)|All participants who received at least one dose of MIRCERA during the maintenance period.||microgram (µg)||Standard Deviation|Mean
50127|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 4|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
50128|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 3|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
50129|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 2|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
50130|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 1|The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.|Month 1|All participants who received at least one dose of MIRCERA during titration period.||microgram (µg)||Standard Deviation|Mean
50131|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Maintenance Period|The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA|Month 5, 6, 7, 8, 9, 10|All participants who received at least one dose of MIRCERA during maintenance period.||g/L||Standard Deviation|Mean
50132|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Titration Period|The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.|Baseline, Month 1, 2, 3, 4|All participants who received at least one dose of MIRCERA during titration period.||g/L||Standard Deviation|Mean
50133|NCT01318512|Primary|Average Dose of MIRCERA at Entry Level|The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.|Baseline|All participants who received at least one dose of MIRCERA during the titration period.||microgram (µg)||Standard Deviation|Mean
50134|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Pain Free by Visit|Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
50135|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Cured by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
50136|NCT01318499|Post-Hoc|Cumulative Percent Clinical Success by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Clinical success occurred when the cell grade was ≤ 1 (0-5 cells) and flare grade was = 0. To be included in the cumulative summary at a visit, a patient must have been declared a clinical success at the visit and remained a clinical success at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one post-operative assessment (intent-to-treat).||Percentage of patients|||Number
50137|NCT01318499|Secondary|Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 7 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
50138|NCT01318499|Primary|Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 14 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.||Percentage of patients|||Number
50139|NCT01318408|Primary|ADAS-cog at Baseline and at 3 Months.|"ADAScog (Alzheimer's Disease Assessment Scale-cognitive subscale) consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Score ranges from 0 - 70.~Lower scores (negative change) indicate improvements on the Alzheimer’s Disease Assessment Scale–Cognitive (ADAS-cog)."|Baseline and Three (3) months|||units on a scale||Standard Deviation|Mean
50140|NCT01318408|Secondary|Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated.||three months||||||
50141|NCT01318408|Primary|MMSE at Baseline and at Three (3) Months.|The MMSE (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of Food and Drug Administration (FDA) products approved for the treatment of AD. The MMSE consists of five components; 1) orientation to time and place, 2) registration of three words, 3) attention and calculation, 4) recall of three words, and 5) language. The scores from each of the five components are summed to obtain the overall MMSE score. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Baseline and Three months|||units on a scale||Standard Deviation|Mean
50142|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.||percentage of participants||95% Confidence Interval|Number
50161|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50143|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 1 minute prior to tracheal extubation|The Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.||percentage of participants||95% Confidence Interval|Number
50144|NCT01318382|Secondary|Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.||percentage of participants||95% Confidence Interval|Number
50145|NCT01318382|Primary|Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 1 minute prior to tracheal extubation|Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.||percentage of participants||95% Confidence Interval|Number
50146|NCT01318278|Secondary|All Cause Mortality||admission to hospital discharge, up to 15 months|||participants|||Number
50147|NCT01318278|Secondary|Neurodevelopmental Outcomes||hospital discharge to follow up at 18-24 months of age||||||
50148|NCT01318278|Secondary|Presence of Bronchopulmonary Dysplasia (BPD)|Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD|36 weeks postmenstrual age|||participants|||Number
50149|NCT01318278|Secondary|Retinopathy of Prematurity Stage 3 or Higher|"All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis.~Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages."|Until hospital discharge, up to 15 months|||participants|||Number
50150|NCT01318278|Secondary|Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound||Until hospital discharge, up to 15 months|||participants|||Number
50151|NCT01318278|Secondary|Presence of Patent Ductus Arteriosus (PDA)||until hospital discharge, up to 12 weeks|||participants|||Number
50152|NCT01318278|Secondary|Ventilator Days||Until hospital discharge, up to 15 months|||days||Inter-Quartile Range|Median
50153|NCT01318278|Secondary|Necrotizing Enterocolitis||until hospital discharge, up to 12 weeks|||participants|||Number
50154|NCT01318278|Secondary|Evidence of Ischemic Changes|Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.|96 hours or until medication completely stopped|||participants|||Number
50155|NCT01318278|Secondary|Urine Output||96 hours or until hypotension resolved and medication completely stopped|||ml/kg/hr||Standard Deviation|Mean
50156|NCT01318278|Secondary|Hyponatremia||96 hours or until medication completely stopped|||participants|||Number
50157|NCT01318278|Secondary|Acid-base Status||96 hours or until hypotension resolved and medication completely stopped|Treatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gases||pH||Standard Deviation|Mean
50158|NCT01318278|Secondary|Heart Rate Change From Baseline|Heart rate change from baseline during study drug administration|96 hours or until hypotension completely resolved and medications stopped|This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.||beats per minute||Standard Deviation|Mean
50159|NCT01318278|Primary|Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life|Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP|24 hours of life|This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.||participants|||Number
50160|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50162|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50163|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50164|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50165|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50166|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50167|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50168|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50169|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50170|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50171|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50172|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50173|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50174|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50175|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50176|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50177|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to 52).|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50178|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50179|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50180|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50181|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50182|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50185|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50186|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50187|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50188|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50189|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50190|NCT01318135|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis.||participants|||Number
50191|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50192|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50193|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50194|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50195|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50196|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50197|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50198|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50199|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50200|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50201|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50202|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50208|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50209|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50210|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50211|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50212|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50213|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50214|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50215|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50216|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50217|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50218|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50219|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50220|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50221|NCT01318122|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period.||participants|||Number
50222|NCT01318109|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
52463|NCT01292226|Secondary|Percentage of Participants With Infection|Infections were graded according to the World Health Organization (WHO) worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population: all enrolled participants||percentage of participants|||Number
50223|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50224|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50225|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50226|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50227|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50228|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50229|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50230|NCT01318109|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50231|NCT01318083|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50232|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50233|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50234|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50235|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50357|NCT01316380|Secondary|Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment|For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline <= -0.5), no change (-0.5 <change from baseline < 0.5) and worsening (change from baseline >= 0.5).|12 weeks|All patients from FAS.||Number of patients|||Number
50236|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50237|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50238|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50239|NCT01318083|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50240|NCT01318070|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50241|NCT01318070|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50242|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50243|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50244|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50245|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
50246|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50247|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50723|NCT01313182|Primary|Surgical Site Infections Occurring Within 12 Months of Surgical Procedure|Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.|12 months|||participants|||Number
50248|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
50249|NCT01317901|Primary|Response|Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the Revised Response Criteria for Malignant Lymphoma|Day 15 and Day 28 of even-numbered cycles|All treated subjects||participants|||Number
50250|NCT01317797|Secondary|Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)|Ritchie articular index (RAI); a joint count that grades the tenderness of 26 joints on a scale of 0-3); the number of swollen joints from 44 joints (swollen44); ESR in mm/hour after 1 hour and the patient’s global disease activity on a Visual Analogue Scale (VAS) of 100 mm (0=no disease activity to right end of the line 100=maximum disease activity) were used to calculate DAS44-ESR using the following formula: DAS44-ESR = 0.54*sqrt(RAI) + 0.065*(swollen44) + 0.33*ln(ESR) + 0.0072*VAS. Lower numbers were better. A negative change from Baseline indicated improvement.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.||score on a scale||Standard Deviation|Mean
50251|NCT01317797|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.||percentage of participants|||Number
50252|NCT01317797|Secondary|Number of Participants With Anti-MT203 Antibodies|Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
50253|NCT01317797|Secondary|Change From Baseline in MT203/GM-CSF Complexes in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118|All randomized participants with data available for analysis.||pg/mL||Standard Deviation|Mean
50254|NCT01317797|Secondary|Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118|All randomized participants with data available for analysis.||pg/mL||Standard Deviation|Mean
50255|NCT01317797|Secondary|Ctrough: Maximum Observed Plasma Concentration Pre-Dose||Days 1, 15 and 29 Pre-dose|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||μg/mL||Full Range|Geometric Mean
50256|NCT01317797|Secondary|Terminal Phase Elimination Half-life (T1/2) for MT203|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated.||days||Full Range|Mean
50257|NCT01317797|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||day*μg/mL||Full Range|Geometric Mean
50258|NCT01317797|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||day*μg/mL||Full Range|Geometric Mean
50259|NCT01317797|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||day*μg/mL||Full Range|Geometric Mean
50260|NCT01317797|Secondary|Cmax: Maximum Observed Plasma Concentration for MT203|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.||μg/mL||Full Range|Geometric Mean
50261|NCT01317797|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|||days||Full Range|Median
50262|NCT01317797|Primary|Number of Participants Reporting One or More Treatment Emergent Adverse Events|An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
50263|NCT01317797|Primary|Number of Participants With Clinically Significant Physical Examination Findings|The physical examination included body system assessments: eyes, head and neck (including thyroid), ears, nose and throat, lymph nodes, cardiovascular, lungs, mammae, abdomen (liver, spleen), genitals, limbs, central and peripheral nervous system, musculoskeletal system, skin & nails, mucosae. The Investigator classified abnormal findings as either clinically significant or not clinically significant.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
50264|NCT01317797|Primary|Number of Participants With Clinically Significant Pulmonary Function Tests|Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
50265|NCT01317797|Primary|Number of Participants With Clinically Significant Vital Signs|Vital signs included Systolic Blood Pressure (BP), Diastolic BP, body temperature, heart rate. Alert values were: BP systolic > 170 mmHg or < 85 mmHg, BP diastolic > 105 mmHg, Difference BP systolic vs. Baseline (pre-treatment) > 40 mmHg or Pulse rate < 35 bpm or > 120 beats per minute (bpm).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
50266|NCT01317797|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Alert values for ECG were: Heart rate < 35 bpm or > 120 bpm, QTc acc. to Bazett (absolute value)> 500 ms or QTc acc. to Bazett (increase versus Baseline (pre-treatment).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
50267|NCT01317797|Primary|Number of Participants With Clinically Significant Clinical Laboratory Results|Blood was collected for Haematology, Chemistry and Coagulation. Urine was collected for Urinalysis. Alert values for laboratory results include the following: Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl-transpeptidase (GGT), alkaline phosphatase (AP), total bilirubin (TBil): > 3 times upper limit of normal (ULN). Creatinine and Glucose: > 2 times ULN. Potassium > 6.0 or < 3.0 mmol/L. Haemoglobin: Male < 8.0 ;Female < 7.0 g/dL. Erythrocytes :Male < 3.5 x 10^12/L or > 7 x 10^12/L;Female < 3.0 x 10^12/L or > 6.5 x 10^12/L. White Blood Cells (WBC): < 2.8 x10^9/L or > 16.0 x 10^9/L. Eosinophils > 20 % of cells in the WBC differential. Platelet Count < 75 x 10^9/L or 600 x 10^9/L. No alert values were identified for Coagulation or Urinalysis.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.||participants|||Number
50268|NCT01317667|Secondary|Over Response Rates and Comparisons for ELISA and TNA Titers|Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion.|Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12|Per-protocol population. Only observations or specimens collected according to the protocol were included in the immunogenicity analyses.||participants|||Number
50269|NCT01317667|Primary|Number of Vaccinated Subjects Any Averse Events and by Location and Severity||Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months|Safety population: any subject receiving a vaccination||participants|||Number
50270|NCT01317615|Secondary|Overall Survival (OS)|OS was defined as the time from date of start of treatment to date of death due to any cause.|12 months|All participants were included in the analysis.||Days||95% Confidence Interval|Median
50271|NCT01317615|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.|6 months|All participants were included in the analysis.||Days||95% Confidence Interval|Median
50272|NCT01317615|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.||Percentage of participants|||Number
50273|NCT01317615|Secondary|Percentage of Participants With Overall Response Rate (ORR)|ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.|3 months|All participants were included in the analysis.||Percentage of participants|||Number
50358|NCT01316380|Secondary|FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
50274|NCT01317615|Secondary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|All participants were included in the analysis.||Percentage of participants|||Number
50275|NCT01317615|Primary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.||Percentage of participants|||Number
50276|NCT01317160|Secondary|Microdialysis|At 2 weeks postoperatively in-vivo microdialysis will be performed on as described by Greve et al 2012 (DOI: 10.1111/j.1600-0838.2012.01475.x). In the microdialysate different substances will be assessed, eg. markers of tendon callus production, procollagen type I (PINP) and type III (PIIINP) N-Terminal propeptide by enzymatic quantification.|2 weeks||||||
50277|NCT01317160|Secondary|Patient-reported Outcome and Physical Activity|The patients’ symptoms and physical activity levels were assessed using four reliable and valid scores; the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group’s questionnaire (EQ-5D).|One year||||||
50278|NCT01317160|Secondary|Venous Thromboembolic Events (VTE)|"At 6 weeks postoperatively the number of participants with VTE events will be assessed by:~1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|6 weeks|||participants|||Number
50279|NCT01317160|Secondary|Functional Outcome - Muscular Endurance Tests (Heel-rise)|The functional outcome will be assessed at 52 weeks post-operatively by validated muscular endurance test, i.e. heel rise test.|one year||||||
50280|NCT01317160|Primary|Venous Thromboembolic Events (VTE)|"At 2 weeks postoperatively the number of participants with VTE events will be assessed by:~1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|2 weeks|Non-compliance was defined by exposure to less than ten hours of IPC. Therefore, two patients were withdrawn on this basis and the treatment group comprised 67 patients at final analysis.||participants|||Number
50281|NCT01317004|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.|6 months|Participants from the safety set, who had values at month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||Percentage of participants|||Number
50282|NCT01317004|Secondary|Change From Baseline in Patient-reported Health Related Quality of Life (QOL)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
50283|NCT01317004|Secondary|Change From Baseline in Patient-reported Depression|The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
50395|NCT01316315|Primary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|24 hours|Any patient that received a dose of N6022 or placebo.||mg/mL||Standard Error|Mean
50284|NCT01317004|Secondary|Change From Baseline in Patient–Reported Effectiveness and Convenience|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
50285|NCT01317004|Secondary|Change From Baseline in Patient-reported Fatigue|The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
50286|NCT01317004|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL)|The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
50287|NCT01317004|Primary|Change From Baseline in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
50288|NCT01316926|Primary|Cmax_steady-state|Cmax_steady-state (ss) is defined as the maximum or “peak” concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
50289|NCT01316926|Primary|Cmin_steady-state|Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
50290|NCT01316926|Primary|Area Under the Curve_steady-state|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_steady-state (ss) is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study||ng/h/ml||Standard Deviation|Mean
50291|NCT01316913|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
50306|NCT01316887|Secondary|Change From Baseline in Hematocrit at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Proportion of red blood cells in blood||Standard Deviation|Mean
50292|NCT01316913|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
50293|NCT01316913|Primary|Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.|Baseline and Day 169|ITT Population: all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
50294|NCT01316900|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population excluding participants from Investigator 040688. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
50295|NCT01316900|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population excluding participants from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
50296|NCT01316900|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants. .|Baseline and Day 169|ITT Population excluding par. from Investigator 040688: all randomized par. who received >=1 dose of study drug, except for those from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.||Liters||Standard Error|Least Squares Mean
50314|NCT01316887|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period|A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.|From the start of study drug up to 52 weeks|ITT Population||Participants|||Number
50745|NCT01312766|Secondary|Clinical Pregnancy Rate,|defined as a pregnancy showing ultrasound embryonic heart activity at 10 – 11 weeks after embryo transfer;|10 – 11 weeks after embryo transfer|||percentage of participants|||Number
50297|NCT01316887|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning’s dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions.|Baseline; Months 1, 3, 6, 9, and 12|ITT Population. The overall number of participants reflects all participants who provided at least one post-treatment assessment. Participants who provided data the specified time points are represented by n=X, X, X in the category titles.||Liters||Standard Error|Least Squares Mean
50298|NCT01316887|Secondary|Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period|Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline.|From the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the summary.||Percentage of rescue-free days||Standard Deviation|Mean
50299|NCT01316887|Secondary|Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period|Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + [2 * number of salbutamol nebules] + [2 * number of ipratropium nebules]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group.|Baseline; from the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the analysis.||Number of puffs per day||Standard Error|Least Squares Mean
50300|NCT01316887|Secondary|Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation|"Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An any time post-Baseline Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists."|Screening; from the start of study drug up to 52 weeks|ITT Population. Only those participants providing at least one post-Baseline interpretation were summarized.||Participants|||Number
50301|NCT01316887|Secondary|Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline|Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists.|From the start of study drug up to 52 weeks|ITT Population||participants|||Number
50302|NCT01316887|Secondary|Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Beats per minute||Standard Deviation|Mean
50303|NCT01316887|Secondary|Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett’s Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia’s Formula (QTcF), and PR Interval Over the Course of the 52-week|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Milliseconds||Standard Deviation|Mean
50304|NCT01316887|Secondary|Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Beats per minute||Standard Deviation|Mean
50305|NCT01316887|Secondary|Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population||Millimeters of mercury (mmHg)||Standard Deviation|Mean
50396|NCT01316302|Secondary|Patient Global Impression of Change|Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.|Baseline to study endpoint (Week 12)|||percentage of self-rated responders|||Number
50307|NCT01316887|Secondary|Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
50308|NCT01316887|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Percentage in blood||Standard Deviation|Mean
50309|NCT01316887|Secondary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
50310|NCT01316887|Secondary|Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
50311|NCT01316887|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
50312|NCT01316887|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
50313|NCT01316887|Secondary|Time to the First On-treatment COPD Exacerbation|An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants.|From the start of study drug up to 52 weeks|ITT Population||Days||Full Range|Median
50315|NCT01316887|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of study drug up to 52 weeks|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug||Participants|||Number
50316|NCT01316692|Other Pre-specified|Correlation Between MLN8237-induced Selective Aurora Kinase A Inhibition in Post-treatment Tumor Sites and Clinical Benefit of MLN8237|In stage 2 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Post-treatment tumor tissue will be assayed for MLN8237-induced selective Aurora Kinase A inhibition and compared to pre-treatment tumor tissue and the results will be compared and contrasted with patients’ objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|unable to collected the required number of tumor samples|||||
50317|NCT01316692|Other Pre-specified|Characterize the de Novo Molecular Mutation Profile of the Melanomas for Association Between Objective Responses to MLN8237 in Patients With Pre-treatment Melanoma Tissue.|In stage 1 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Tissue will be assayed for mutations that are neither parent-possessed, nor able to be transmitted, in pre- and in post-treatment tissue and the results will be compared and contrasted with patients’ objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|Collected samples of tumors were very limited. It did not allow us to perform the described assays|||||
50318|NCT01316692|Secondary|Number of Grade 3 and 4 Study-related Toxicities|Event are graded using National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death. toxicities measured on day 1 of each 21-day cycle. Treatment continues to disease progression, toxicity, or withdrawal for other reasons.|at 18 weeks|total numbers of adverse events, patients experiencing grade 3 and 4 related to study treatment||toxicities|||Number
50319|NCT01316692|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details) Evaluated every 3 months for 12 months, then every 6 months|On treatment date to last follow-up or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
50320|NCT01316692|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the duration in time from start of therapy to last follow-up, disease progression, or death for any reason.measured every 6 weeks for 24 weeks, and then every 12 weeks or to last date known alive or death, determined every 6 months for up to 5 years. For those who are alive and without progression, they are censored at the last date known alive.|On treatment date to last follow-up, disease progression or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
50321|NCT01316692|Primary|Overall Response Rate|If 2 or more of 23 pts show CR/PR in stage 1, then an additional 33 pts will be enrolled in stage 2. If 6 or more of the total 56 pts show CR/PR at 18 weeks, then further clinical trials will be warranted. Per Response Evaluation Criteria in Solid Tumor (RECIST)1.1: Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|At 18 weeks|All patients with Objective Response, defined as a complete or partial response.||participants||95% Confidence Interval|Number
50322|NCT01316614|Secondary|Amount of Blood||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
50323|NCT01316614|Secondary|Contamination|Percentage of area of slide that represents GI contamination|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
50324|NCT01316614|Secondary|Adequacy of Specimen||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
50325|NCT01316614|Secondary|Degree of Cellularity|Number of cells per slide|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
50326|NCT01316614|Secondary|Degree of Cellularity|Percentage of area of slide that contains cells of the representative lesion|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
50397|NCT01316302|Secondary|Clinical Global Impression of Improvement Scale (CGI-I)|CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.|Baseline to Week 12|||% of subjects who were CGI-I responders|||Number
50327|NCT01316614|Primary|Compare Adequacy of Diagnoses in Passes With and Without a Stylet|"The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet.~There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes."|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 overall passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.||passes|||Number
50328|NCT01316575|Secondary|Length of Stay in Hospital||Up to 2 weeks|||days||Standard Deviation|Mean
50329|NCT01316575|Secondary|Number of Participants Requiring Admission to ICU||Up to 2 weeks|||participants|||Number
50330|NCT01316575|Secondary|Number of Participants Requiring Reintubation||Up to 2 weeks|||participants|||Number
50331|NCT01316575|Primary|Alveolar - Arterial Gradient|Alveolar - arterial gradient|1 hour following admission to PACU|From the literature, a sample size of 19 subjects per group is required for a power >0.9 and alpha <0.05 assuming a normalised difference in A-a gradient between groups of 0.33 and a Standard Deviation (SD) of 0.33||torr||Standard Deviation|Mean
50332|NCT01316419|Secondary|Incidence and Severity of Reported Adverse Events.|Incidence as per the severity of reported adverse events is presented.|24±2 weeks|Patients having received at least one dose of Twynsta tablets||participants|||Number
50333|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.||percentage of participants|||Number
50334|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|12±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.||percentage of participants|||Number
50335|NCT01316419|Secondary|Percentage of Patients Achieving Normal Body Mass Index (BMI)|Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.||percentage of participants|||Number
50336|NCT01316419|Secondary|Mean Blood Lipid Change - Total Cholesterol|Mean blood lipid change - Total Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
50337|NCT01316419|Secondary|Mean Blood Lipid Change - Triglyceride|Mean blood lipid change - Triglyceride|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
50338|NCT01316419|Secondary|Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol|Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
50339|NCT01316419|Secondary|Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol|Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.||mg/dl||Standard Deviation|Mean
50340|NCT01316419|Secondary|Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease|Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease|24±2 weeks|All patients with diabetes, kidney disease or both (diabetes + kidney disease)||percentage of participants|||Number
50341|NCT01316419|Secondary|EuroQol (EQ) Visual Analogue Scale (VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘best imaginable health state’ and ‘worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health.|baseline and 24±2 weeks|Patients with a baseline and an endpoint EQ VAS response||scores on a scale||Standard Deviation|Mean
50342|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
50355|NCT01316380|Secondary|Time to First Asthma Exacerbation During the 12-week Treatment.|An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms.|12 weeks|All patients from FAS.||Days||Inter-Quartile Range|Median
50343|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
50344|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
50345|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||scores on a scale||Standard Deviation|Mean
50346|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response||scores on a scale||Standard Deviation|Mean
50347|NCT01316419|Secondary|Percentage of Patients Achieving SBP Response|Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||percentage of participants|||Number
50348|NCT01316419|Primary|Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||mmHg||Standard Deviation|Mean
50349|NCT01316419|Secondary|Percentage of Patients Achieving DBP Response|Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||percentage of participants|||Number
50350|NCT01316419|Secondary|Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.|Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||percentage of participants|||Number
50351|NCT01316419|Primary|Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.||mmHg||Standard Deviation|Mean
50352|NCT01316380|Secondary|Use of Rescue Medication During Nighttime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.||puffs of rescue medication||Standard Error|Mean
50353|NCT01316380|Secondary|Use of Rescue Medication During Daytime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.||puffs of rescue medication||Standard Error|Mean
50354|NCT01316380|Secondary|Use of Rescue Medication During 24h Period|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.||puffs of rescue medication||Standard Error|Mean
50356|NCT01316380|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment.|Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days.|12 weeks|All patients from FAS.||Days||Inter-Quartile Range|Median
50359|NCT01316380|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
50360|NCT01316380|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
50361|NCT01316380|Secondary|Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.||Liter||Standard Error|Least Squares Mean
50362|NCT01316380|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who received at least one dose of randomized trial medication.||Liter||Standard Error|Least Squares Mean
50363|NCT01316341|Primary|Fasting Plasma Glucose (FPG) Change From Baseline|Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.||mg/dL||Standard Deviation|Mean
50364|NCT01316341|Primary|Urinary Glucose Excretion (UGE) Change From Baseline|Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.||mg||Standard Deviation|Mean
50365|NCT01316341|Secondary|Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference|"Clinically relevant abnormalities for protocol-specified significant adverse events, hypoglycaemic events, vital signs, blood chemistry, use of rescue therapy, change in body weight and change in waist circumference.~Results shown are for hypoglycaemic events, as this was the only event that occurred for this endpoint."|Drug administration until end of trial, up to 21 days|Treated set (TS) includes all patients who were documented to have taken at least one dose of investigational treatment.||participants|||Number
50366|NCT01316341|Primary|Predose Plasma Concentration Before Planned Dose x (Cpre,x)|"Predose plasma concentration of empagliflozin (empa) before planned dose by day.~This endpoint in steady state is identical to Cmin,ss."|5 minutes before drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
50367|NCT01316341|Primary|Accumulation Ratio Based on Cmax (R A,Cmax)|Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration between days 5 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||Ratio||Geometric Coefficient of Variation|Geometric Mean
50368|NCT01316341|Primary|Accumulation Ratio Based on AUC (R A,AUC)|Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration on days 1 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||Ratio||Geometric Coefficient of Variation|Geometric Mean
50369|NCT01316341|Primary|Renal Clearance at Steady State (CL R,ss)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
50370|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss)|Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
50371|NCT01316341|Primary|Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss)|Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol||Geometric Coefficient of Variation|Geometric Mean
50372|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss)|Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||L||Geometric Coefficient of Variation|Geometric Mean
50373|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss)|Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
50374|NCT01316341|Primary|Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
50375|NCT01316341|Primary|Terminal Half-life in Plasma at Steady State (t1/2,ss)|Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
50376|NCT01316341|Primary|Terminal Rate Constant in Plasma at Steady State (λz,ss)|Terminal rate constant in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||1/h||Geometric Coefficient of Variation|Geometric Mean
50377|NCT01316341|Primary|Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
50378|NCT01316341|Primary|Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss)|Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
50379|NCT01316341|Primary|Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss)|Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
50380|NCT01316341|Primary|Renal Clearance After Extravascular Administration (CL R,0-48)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
50381|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24).|Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
50422|NCT01316224|Secondary|Mean Time to First Occurrence of PsA Signs or Symptoms|The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.||Years||95% Confidence Interval|Mean
50382|NCT01316341|Primary|Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24)|Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol||Geometric Coefficient of Variation|Geometric Mean
50383|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/F)|Apparent volume of distribution during the terminal phase λz, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||L||Geometric Coefficient of Variation|Geometric Mean
50384|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F)|Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||mL/min||Geometric Coefficient of Variation|Geometric Mean
50385|NCT01316341|Primary|Mean Residence Time (MRTpo)|Mean residence time of empagliflozin (empa) in the body after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
50386|NCT01316341|Primary|Terminal Half-life (t1/2)|Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
50387|NCT01316341|Primary|Terminal Rate Constant (λz)|Terminal Rate Constant in Plasma (λz), after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||1/h||Geometric Coefficient of Variation|Geometric Mean
50388|NCT01316341|Primary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
50389|NCT01316341|Primary|Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
50390|NCT01316341|Primary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||hours||Geometric Coefficient of Variation|Geometric Mean
50391|NCT01316341|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
50392|NCT01316315|Other Pre-specified|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing||7 Days|Any patient that received a dose of N6022 or Placebo||mg/mL||Standard Error|Mean
50393|NCT01316315|Secondary|To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.|Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed.|10 Weeks|Any patient that received a dose of N6022 or placebo||Adverse Events|||Number
50394|NCT01316315|Secondary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|8 hours|Any patient that received a dose of N6022 or Placebo||mg/mL||Standard Error|Mean
50423|NCT01316055|Secondary|The Steady State Fractional Clearance, Calculated as the Dose / AUC(0-12) (CL/Fss) of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT||liter/hour||90% Confidence Interval|Geometric Mean
50398|NCT01316302|Primary|Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score|Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.|Baseline to study endpoint (Week 12)|The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).||Scores on a scale||Standard Deviation|Mean
50399|NCT01316263|Secondary|Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results|Participants with Treatment Emergent (TE) anti-olaratumab (IMC-3G3) antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles)|All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.||percentage of participants|||Number
50400|NCT01316263|Secondary|Volume of Distribution at Steady State (Vss)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. Vss was not reported. Vss could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
50401|NCT01316263|Secondary|Clearance (CL)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. CL was not reported. CL could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
50402|NCT01316263|Secondary|Half Life (t½)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. t1/2 was not reported. t1/2 could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
50403|NCT01316263|Secondary|Area Under the Curve (AUC)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. AUC was not reported. AUC could not be calculated due to an insufficient number of olaratumab serum concentrations.|||||
50404|NCT01316263|Secondary|Maximum Concentration (Cmax)||Day 1 of Cycles 1 and 3 (14-day cycles)|All participants who had evaluable pharmacokinetic (PK) Cmax results at the specific time point. Due to the limited data, Cmax is not representative of the study population.||nanograms per milliliter (ng/mL)||Full Range|Mean
50405|NCT01316263|Secondary|Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]|DCR defined as CR, PR or SD using RECIST v1.1 criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify PD, taking as reference the smallest sum diameter since the treatment started. PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. Percentage of participants=(number of participants with CR+PR+SD/number of participants in group) * 100.|Baseline up to 35.9 weeks|All participants who received any study drug.||percentage of participants||90% Confidence Interval|Number
50406|NCT01316263|Secondary|Number of Participants With Adverse Events (AE) and Participants Who Died|Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. The number of participants who died due to an AE or disease progression are also reported.|Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up|All participants who received any study drug.||participants|||Number
50407|NCT01316263|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose of study drug to the date of death from any cause. Participants who were alive at the end of the post-study follow-up or were lost to follow-up were censored on the last date the participant was known to be alive.|Date of first dose of study drug to the date of death from any cause up to 57.3 weeks|All participants who received any study drug. Participants censored: PDGFRα Mutant=4, PDGFRα Wild-type=4.||weeks||90% Confidence Interval|Median
50408|NCT01316263|Secondary|Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]|The ORR was the best overall response of CR and PR using RECIST, v1.1 criteria. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator that calculated the response rate. Percentage of participants = (number of participants achieving a response/total of participants treated) * 100.|Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up|All participants who received any study drug.||percentage of participants||90% Confidence Interval|Number
50409|NCT01316263|Secondary|Progression-Free Survival (PFS)|PFS defined as the duration from date of first dose of study drug until first radiographic documentation of PD using RECIST, v1.1 criteria or death from any cause. PD defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. Participants who died with no prior PD were considered to have progressed on day of death. Participants who did not progress or were lost to follow-up were censored at date of last radiographic tumor assessment; if no assessment was available censoring was at date of registration. If death or PD occurred after 2 consecutive missing radiographic visits censoring was date of last radiographic visit prior to missed visits. Use of new anticancer therapy prior to PD, censoring was date of last radiographic assessment prior to new therapy.|Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks|All participants who received any study drug. Censored participants: PDGFRα Mutant=2, PDGFRα Wild-Type=0.||weeks||90% Confidence Interval|Median
50424|NCT01316055|Secondary|The Maximum Measured Plasma Concentration (Cmax) at Steady State, of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT||nanogram/milliliter||90% Confidence Interval|Geometric Mean
50746|NCT01312766|Secondary|Implantation Rate|defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;|10-11 weeks after embryo transfer|||percentage of embryos transferred||Standard Deviation|Mean
50410|NCT01316263|Primary|Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks|Clinical benefit was defined as CR, PR, or SD using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v1.1) criteria. CR: disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR: ≥30% decrease in sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. PD: increase ≥20% in sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or appearance of 1 or more new lesions was considered progression. Percentage of participants=(participants with CR+PR+SD/participants in group) *100.|12 weeks|All participants who received any study drug.||percentage of participants||90% Confidence Interval|Number
50411|NCT01316224|Secondary|Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%|This outcome measure was not calculated.|At Baseline, Week 24, and Week 48||||||
50412|NCT01316224|Secondary|Incidence Rate of PsA Since Psoriasis Diagnosis|"The number of new PsA cases were determined by:~PsA defined by a rheumatologist; or~A participant with inflamed joints >0 and CASPAR score >=3; or~Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA)."|Baseline up to Visit 4 (month 12)|ITT population||new PsA cases per 100 person years||95% Confidence Interval|Number
50413|NCT01316224|Primary|Percentage of Participants Who Developed Signs or Symptoms of PsA|Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
50414|NCT01316224|Primary|Percentage of Participants Who Developed Psoriatic Arthritis (PsA)|"A participant is said to have PsA if they meet the following criteria:~PsA defined by a rheumatologist; or~A participant with inflamed joints >0 and CASPAR score >=3; or~Participant meeting at least one of the two previous definitions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
50415|NCT01316224|Secondary|Percentage of Participants With Joint Symptoms|Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
50416|NCT01316224|Secondary|Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero|"Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
50417|NCT01316224|Secondary|Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point).|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||Percentage of participants|||Number
50418|NCT01316224|Secondary|Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.||CASPAR score||Standard Deviation|Mean
50419|NCT01316224|Secondary|Mean Change in Quality of Life (QoL)|The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|ITT population||Score on scale||Standard Deviation|Mean
50420|NCT01316224|Secondary|Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA|Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.||Percentage of participants|||Number
50421|NCT01316224|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease).|At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)|ITT population||PASI score||Standard Deviation|Mean
50425|NCT01316055|Primary|The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).|AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.|0 and 1,2,3,4,5,6,8, and 12 hours after the last dose|Intention to treat (ITT)||hour*nanogram/milliliter||90% Confidence Interval|Geometric Mean
50426|NCT01316042|Primary|Change in Serum DHEAS Levels|Change in DHEAS level was constructed per subject as the 1-year measurement minus the baseline measurement. Only descriptive statistics are provided, statistical tests were not conducted given the extremely small sample size per group.|1 year|||ug/dL||Full Range|Mean
50427|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During Period When Migraine is Absent (Interictal Phase)(Part III, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 2 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO|||||
50428|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During a Migraine Attack (Ictal Phase)(Part III, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 1 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO|||||
50429|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|In Part I, Period 2 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 1, 2, 3 and 4 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part 1, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol||μM||Standard Deviation|Mean
50430|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 miniutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol||percent CGRP RO|||Number
50431|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|In Part I, Period 1 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 2, 3, 4 and 5 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol||μM||Standard Deviation|Mean
50454|NCT01315158|Secondary|Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups|The number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.|24-48 hours|||participants|||Number
50432|NCT01315847|Primary|Brain Calcitonin Gene-related Peptide (CGRP) Receptor Occupancy (RO) Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, regions of interest (ROIs) were drawn throughout cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue time-activity curves (TACs). Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. Total volume of distribution (VT), an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. Change in VT between baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol||percent CGRP RO|||Number
50433|NCT01315847|Primary|Number of Participants With AEs (Part III)|Any AEs occurring among participants (all were migraine patients) in Part III of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part III of study (Up to approximately 6 months)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part III of study.||participants|||Number
50434|NCT01315847|Primary|Number of Participants With Adverse Events (AEs) (Part I)|Any AEs occurring among participants (all were healthy subjects) in Part I of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part I of study (Up to approximately 14 weeks)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part I of study.||participants|||Number
50435|NCT01315665|Secondary|Measure of Neutrophil Migration Into the Gingival Crevices|Change in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.|Baseline and end of 5 day treatment period|||Neutrophils/mL (Log10)||Standard Deviation|Mean
50436|NCT01315665|Secondary|Measures of Oxidative Stress in Urine|Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period|||ng/mg creatinine (Log10)||Standard Deviation|Mean
50437|NCT01315665|Secondary|Measures of Glutathione From Blood Lymphocytes|Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period|||Micro Molar||Standard Deviation|Mean
50438|NCT01315665|Secondary|Measures of Lipid Peroxidation in Nasal Epithelial Cells|Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)|End of 5 day treatment period|Data not collected and will not be analyzed.|||||
50439|NCT01315665|Primary|Nrf2 Activation in Nasal Epithelial Cells|Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)|Baseline and of end of 5 day treatment period|||participants|||Number
50440|NCT01315574|Secondary|Tear Film Break-Up Time|Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.|At the 6 month follow-up time point|Two subjects did not complete 6-month follow up visit. Data was not collected and analysis not completed.||Seconds||Standard Deviation|Mean
50441|NCT01315574|Secondary|Corneal Fluorescein Staining Score|Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.|At the 6 month follow-up time point|Two subjects did not complete 6-month follow up visit. Data was not collected and analysis not completed.||units on a scale (1-4)||Standard Deviation|Mean
50442|NCT01315574|Primary|Effectiveness in Lowering Intraocular Pressure|Applanation tonometry will be used to measure patients' intraocular pressure|At the 6 month follow-up time point|Two subjects did not complete 6-month follow up visit. Data was not collected and analysis not completed.||mmHg||Standard Deviation|Mean
50443|NCT01315249|Secondary|Number of Participants With Adverse Events|The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.|26 weeks|Safety set includes all participants who received at least one dose of study drug.||participants|||Number
50444|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (26 Weeks)|After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|26 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.~flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."||Liters||Standard Error|Least Squares Mean
50492|NCT01314417|Secondary|Number of Participants Experiencing a Complete Resolution of Fluid as Seen on OCT at Any Time During the Study Period||Baseline and Week 74|||participants|||Number
50445|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (12 Weeks)|After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|12 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.~flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."||Liters||Standard Error|Least Squares Mean
50446|NCT01315249|Secondary|Change From Baseline in Symptom Scores Reported Using the Ediary|"Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.~Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.~0 is the minimum score = “none” or “No symptoms” or “never” or “No”~= mild, a little~= moderate~= severe For the scale range provided, high values represent a worse outcome."|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||units on a scale||Standard Error|Least Squares Mean
50447|NCT01315249|Secondary|Mean Change From Baseline in Daily Number of Puffs of Rescue Medication|Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.|Baseline, 12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||puffs||Standard Error|Least Squares Mean
50448|NCT01315249|Secondary|Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)|The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||units on a scale||Standard Error|Least Squares Mean
50449|NCT01315249|Secondary|Focal Score of the Transitional Dyspnea Index (TDI)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||units on a scale||Standard Error|Least Squares Mean
50450|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 26)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
50451|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 12)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
50452|NCT01315249|Secondary|Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours|Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
50453|NCT01315249|Primary|Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.|Week 26|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.||liters||Standard Error|Least Squares Mean
50747|NCT01312766|Secondary|17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;||up to 23 days after treatment start|||pg/ml||Standard Deviation|Mean
50455|NCT01315158|Secondary|Patient Tolerance as Assessed by Endoscopists|The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.|24-48 hours|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.|||||
50456|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication||One year|||incidences|||Number
50457|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline)||One year|||incidences|||Number
50458|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)||One year|||incidences|||Number
50459|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)||One year|||participants|||Number
50460|NCT01315158|Secondary|Compare Propofol Doses Between the Two Groups|The dose of propofol used between the two groups will be compared|One day (during procedure)|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.|||||
50461|NCT01315158|Secondary|Number of Participants Who Experience Other Sedation Related Complications|Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups|One day (during procedure)|||participants|||Number
50462|NCT01315158|Primary|Number of Participants Who Experience Airway Maneuvers|In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.|One day (during procedure)|||participants|||Number
50463|NCT01315145|Primary|Percentage of Participants With a 2-point Improvement in Visual Analogue Scale|The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.|16 weeks|All participants who reported 16 week outcomes are included in this analysis.||percentage of responders|||Number
50464|NCT01315028|Secondary|Global Assessment of Functioning (GAF)|Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities.|monthly until October 2011|||units on a scale||Standard Deviation|Mean
50465|NCT01315028|Secondary|The Internal State Scale (ISS) (Bauer et al, 1991)|"The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200).~The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows:~Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania >155 >125 Mixed State >155 <125 Euthymia <155 >125 Depression <155"|monthly until October 2011|||units on a scale||Standard Deviation|Mean
50466|NCT01315028|Primary|Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]|"The Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are:~0 to 15 – normal /symptom absent 15 to 20 – mild 21 to 28 – moderate >34 – severe"|Baseline to End of Study|||units on a scale||Standard Deviation|Mean
50467|NCT01315028|Primary|Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)|"The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are:~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Baseline to End of Study.|||units on a scale||Standard Deviation|Mean
50468|NCT01315002|Primary|Error Percentage in Antisaccade Task|Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.|Three hours after patch application|||Error Percentage in Antisaccade Task||Standard Deviation|Mean
50469|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Strong urge episodes||95% Confidence Interval|Least Squares Mean
50470|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Incontinence episodes||95% Confidence Interval|Least Squares Mean
50471|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
50472|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Micturitions at Week 52|Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Micturitions||95% Confidence Interval|Least Squares Mean
50473|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Strong urge episodes||95% Confidence Interval|Least Squares Mean
50474|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Incontinence episodes||95% Confidence Interval|Least Squares Mean
50475|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
50476|NCT01314872|Primary|Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 52 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
50541|NCT01314014|Secondary|Median Time to Progression Free Survival in Participants With Relapsed/Refractory Indolent and Aggressive Lymphomas|Measured from start of treatment until disease progression or death from any cause.|up to 25 months|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.||months||Full Range|Median
50477|NCT01314872|Primary|Extension Study: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 54 weeks (including 2-week follow-up)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
50478|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
50479|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
50480|NCT01314872|Primary|Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.||Micturitions||95% Confidence Interval|Least Squares Mean
50481|NCT01314742|Primary|Duration of Mechanical Ventilation|Time on invasive mechanical ventilation will be measured in days|3 days|||ventilator-days||Standard Deviation|Mean
50482|NCT01314742|Primary|Feasibility|percentage of participants with retention|duration of study, for up to 30 months|||percentage of participants retained|||Number
50483|NCT01314716|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.~Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough~Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set||days||95% Confidence Interval|Median
50484|NCT01314716|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.||units on a scale||Standard Deviation|Mean
50485|NCT01314716|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.||units on a scale||Standard Deviation|Mean
50486|NCT01314703|Primary|Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.|the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.|10 minutes after single application of test material|27 subjects were treated with ChloraPrep on the abdomen and groin treatment sites. 26 of the 27 abdomen sites met the qualifying bacterial baseline count and were included in the analysis. 25 of the groin sites met the qualifying bacterial baseline count and were included in the analysis.||log 10 colony forming units||95% Confidence Interval|Mean
50487|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.|Plasma measurements of malondialdehyde, a marker of lipid peroxidation was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation|Day 0 and 7 of intervention|||microM||Standard Error|Mean
50488|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.|Plasma measurements of gamma-tocopherol was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation.|Day 0 and 7 of intervention|||microM||Standard Error|Mean
50489|NCT01314443|Primary|Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0|Flow-mediated dilation (FMD) of the brachial artery is measured to assess vascular endothelial function. FMD is obtained by monitoring change in vessel diameter before and after brachial artery occlusion with a blood pressure cuff. The unit of FMD is % and is calculated using the following equation: FMD = [(peak dilation at post occlusion - vessel diameter at preocclusion)/vessel diameter at preocclusion]*100.|Day 0 and 7 of intervention|Analysis was performed on all participants completing the 7 d intervention||% of preocclusion diameter||Standard Error|Mean
50490|NCT01314417|Secondary|Cytokine Analysis on Aqueous Samples to Assess Whether Intravitreal Injection of Methotrexate Affects Aqueous Inflammatory Cytokine Levels||Baseline and Week 74||||||
50491|NCT01314417|Secondary|Observation of Dose Reduction of Systemic Immunosuppression or Steroids Over the Course of the Study Period||Baseline and Week 74||||||
50493|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 24 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||participants|||Number
50494|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 12 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||participants|||Number
50495|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 24 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||participants|||Number
50496|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 12 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||participants|||Number
50497|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 20 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20|||ETDRS Letters|Participants|Standard Deviation|Mean
50498|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||ETDRS Letters||Standard Deviation|Mean
50499|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 16 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16|||ETDRS Letters|Participants|Standard Deviation|Mean
50500|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||ETDRS Letters|Participants|Standard Deviation|Mean
50501|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 8 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8|||ETDRS Letters|Participants|Standard Deviation|Mean
50502|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 4 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4|||ETDRS Letters|Participants|Standard Deviation|Mean
50503|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 24 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||µm|Participants|Standard Deviation|Mean
50504|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 20 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20|||µm|Participants|Standard Deviation|Mean
50505|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 16 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16|||µm|Participants|Standard Deviation|Mean
50506|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 12 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||µm|Participants|Standard Deviation|Mean
50507|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 8 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8|||µm|Participants|Standard Deviation|Mean
50508|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 4 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4|||µm|Participants|Standard Deviation|Mean
50509|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 24 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24|||percentage of change from baseline||Standard Deviation|Mean
50510|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 20 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20|||percentage of change from baseline||Standard Deviation|Mean
50748|NCT01312766|Secondary|Controlled Ovarian Stimulation Duration (Days)||up to 23 days after treatment start|||days||Standard Deviation|Mean
50749|NCT01312766|Secondary|Positive b-hCG Test||up to 5 weeks after treatment start|||percentage of participants|||Number
50511|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 16 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16|||percentage of change from baseline||Standard Deviation|Mean
50512|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 12 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12|||percentage of change from baseline||Standard Deviation|Mean
50513|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 8 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8|||percentage of change from baseline||Standard Deviation|Mean
50514|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 4 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4|||percentage of change from baseline||Standard Deviation|Mean
50515|NCT01314417|Primary|Number of Participants Who Meet the Definition of Treatment Success Within 12 Weeks From Baseline.|"Treatment success is defined as achieving at least a 1-step decrease in the LogScore scale for central macular thickness.~A decrease of at least 1-step on the logOCT scale, where Change in logOCT=log(follow-up thickness/200) - log(baseline thickness/200) is considered clinically significant. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness and represents greater than twice the variability of retinal thickness measurements (approximately 25-30 µ).~Examples of OCT measurements with their corresponding LogScore, where LogScore=10xlogOCT are as follows:~LogScore 0 = OCT 200 µm, LogScore 1 = OCT 250 µm, LogScore 2 = OCT 320 µm, LogScore 3 = OCT 400 µm, LogScore 4 = OCT 500 µm, LogScore 5 = OCT 640 µm, LogScore 6 = OCT 800 µm, LogScore 7 = OCT 1000 µm"|12 weeks|||Participants|||Number
50516|NCT01314261|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.|Week 4 through Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
50517|NCT01314261|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Full Range|Median
50518|NCT01314261|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Full Range|Median
50519|NCT01314261|Secondary|Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days.|Approximately 12 weeks|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||Days||95% Confidence Interval|Median
50555|NCT01313923|Primary|Improvement of ABSIS Score While Reducing Steroid Dosage|"Measurement of disease severity will be quantified using ABSIS (Autoimmune Bullous Skin Disorder Intensity Score). Improvement in disease control is quantified by the maintenance or improvement of ABSIS score while reducing steroid dosage.~No results as study has been terminated early by the investigator."|Expected time line 24 months|This outcome was not assessed because no participant completed any visits of the study|||||
50520|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.|24 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
50521|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.|12 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
50522|NCT01314261|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis.||percentage of participants|||Number
50523|NCT01314261|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng*hr/mL||Standard Deviation|Mean
50524|NCT01314261|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||Hours||Standard Deviation|Mean
50525|NCT01314261|Primary|Maximum Plasma Concentration (Cmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
50526|NCT01314261|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.|Baseline and Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.||percentage of participants|||Number
50527|NCT01314261|Primary|Percentage of Participants With 4-week Rapid Virologic Response (RVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.|Week 4|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.||percentage of participants|||Number
50528|NCT01314118|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.|End of Cycle 3 (Approximately Month 3)|Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.||Percentage of Participants||95% Confidence Interval|Number
50556|NCT01313884|Secondary|Progression Free Survival||24 months||||||
50845|NCT01311024|Secondary|Hospital-diagnosed Pneumonia|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
50846|NCT01311024|Secondary|Invasive Pneumococcal Disease|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
50529|NCT01314118|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
50530|NCT01314118|Secondary|Time to Radiographic Evidence of Disease Progression (TTRP)|Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
50531|NCT01314118|Primary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.|End of core study visit (Approximately at Month 6)|Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.||Percentage of participants||95% Confidence Interval|Number
50532|NCT01314105|Secondary|Change From Baseline in Safety Laboratory Parameters|"Change from baseline in safety laboratory parameters.~As the study is still ongoing, this endpoint has not yet been analysed."|From the first drug administration until 28 days after the last drug administration, up to 50 months|Treated set which included all patients who were administered at least one dose of any study medication|||||
50533|NCT01314105|Secondary|Frequency of All Adverse Events Graded by CTCAE (Common Terminology Criteria for Adverse Events) Version 3.0|"Frequency of all adverse events graded by CTCAE (Common Terminology Criteria for Adverse Events) version 3.0.~As the study is still ongoing, this endpoint has not yet been analysed."|From the first drug administration until 28 days after the last drug administration, up to 50 months|Treated set which included all patients who were administered at least one dose of any study medication|||||
50534|NCT01314105|Secondary|The Maximum Measured Plasma Concentration of Nintedanib|"The maximum measured plasma concentration (Cmax) of nintedanib.~As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||||
50535|NCT01314105|Secondary|Area Under the Curve of Nintedanib|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) and area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz) of nintedanib~As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||||
50536|NCT01314105|Secondary|The Maximum Measured Plasma Concentration of Carboplatin|"The maximum measured plasma concentration of carboplatin (determined as ultrafiltrable and total platinum)~As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set|||||
50537|NCT01314105|Secondary|Area Under the Curve of Carboplatin|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) and area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz) of Carboplatin (determined as ultrafiltrable and total platinum)~As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set|||||
50538|NCT01314105|Secondary|The Maximum Measured Plasma Concentration of PLD|"The maximum measured plasma concentration (Cmax) of pegylated liposomal doxorubicin (PLD) (Total Plasma Doxorubicin and Doxorubicinol)~As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set|||||
50539|NCT01314105|Secondary|Area Under the Curve of PLD|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) and area under the plasma concentration-time curve over the time interval from zero to the time of the last quantifiable drug concentration (AUC0-tz) of pegylated liposomal doxorubicin (PLD) (total plasma doxorubicin and doxorubicinol)~As the study is still ongoing, this endpoint has not yet been analysed."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|Pharmacokinetic set (PK set) which included all patients who were administered at least one dose of any study medication and who were documented to have received at least one dose of Nintedanib and who have at least one valid drug plasma concentration available.|||||
50540|NCT01314105|Primary|Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1|Maximum Tolerated Dose (MTD) of Nintedanib in combination with carboplatin and pegylated liposomal doxorubicin based on the occurrence of dose limiting toxicities (DLTs) during treatment course 1. MTD will be determined among the first 6 evaluable patients in each dose level. MTD is the highest dose at which the incidence of DLT is less than 2/6.|28 days|MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of Carboplatin and PLD, started Nintedanib (Nin) and did not miss more than 13 doses of Nin and/or took 1 dose of Carboplatin and PLD, started Nin and discontinued treatment due to a dose limiting toxicity during the MTD period||participants|||Number
50542|NCT01314014|Primary|Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas|CT, PET, or MRI scans for the assessment of objective tumor responses were performed at baseline, after cycle 2, and every 3 cycles thereafter until disease progression. Standard response criteria from the International Harmonization Project on Lymphoma were used for classification of objective tumor responses. Response was defined as PR (Regression of measuable disease and no new sites) if >= 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes (a) [18F]fluorodeoxyglucose (FDG)-avid or PET prior to therapy; one or more (PET) positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|One year|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.||percentage of participants||95% Confidence Interval|Number
50543|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 4|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 4|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
50544|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 1|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 1|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
50545|NCT01314001|Secondary|Total Side-Effect Severity Index at Target Quit Date|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Target Quit Date (Week 0)|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
50546|NCT01314001|Secondary|Total Side-Effect Severity Index at Pre-Quit|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Pre-Quit (Week -1/Baseline)|Intent-to-treat population (all subjects who received at least one dose of intervention).||units on a scale||Standard Deviation|Mean
50547|NCT01314001|Secondary|7-day Point Prevalence Quit Rate at 6-month Follow up Survey|The percentage of ITT subjects who were verified as abstinent at the 6-month follow up survey. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 24|Intent-to-treat population (all subjects who received at least one dose of intervention).||percentage of ITT subjects|||Number
50548|NCT01314001|Primary|7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)|The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 11|Intent-to-treat population (all subjects who received at least one dose of intervention).||percentage of ITT subjects|||Number
50549|NCT01313936|Secondary|Changes in Standardized Uptake Values on FDG-PET Scans|To describe changes in standardized uptake values (SUVs) obtained by 18FDG-PET scan at study entry and in response to one cycle of protocol therapy.|One year||||||
50550|NCT01313936|Secondary|Changes in Diarrhea|To describe the rate of protocol associated diarrhea according to UGT1A1 genotype.|One year||||||
50551|NCT01313936|Secondary|Therapeutic Response Rate in Patients|To estimate the therapeutic response rate to this regimen according to the NANT modified-version of the International Neuroblastoma Response Criteria.|6 weeks|||Responses|||Number
50552|NCT01313936|Primary|Number of Participants With Toxicities and Adverse Events as a Measure of Safety|To describe the toxicities of 131I-MIBG when given with irinotecan/vincristine on a 5-day schedule.|Continuously||||||
50553|NCT01313936|Primary|Number of Participants With Dose-limiting Toxicity as a Measure of Tolerability|To determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are tolerable when given with irinotecan/vincristine on a 5-day schedule to children and young adults with high-risk refractory/relapsed neuroblastoma.|6 weeks|||participants with DLT|||Number
50554|NCT01313923|Secondary|Statistical Measures|"The statistical goal is to observe success, an improvement in disease control while up-titrating sirolimus dosage. As there will be no control group, the subject or progress at the end of the study will be compared to their baseline at the beginning of the study. The subject and disease severity at the beginning of the study will be compared to the disease severity at each visit and be correlated with the dosage of sirolimus and corticosteroid. However, since no patient completed the study, the outcome and any data collected was not assessed."|Intended assessment at 24 months||12/2016||||
50557|NCT01313884|Primary|Overall Response Rate (Partial and Complete Response)|"Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for 2 years or until progression of disease or initiation of new anticancer therapy.~Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters."|Up to 24 months|||Participants|||Count of Participants
50558|NCT01313858|Primary|Number of Participants Who Experienced at Least One Serious Adverse Event|A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.||Participants|||Number
50559|NCT01313858|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.||Participants|||Number
50560|NCT01313858|Primary|Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement."|Baseline and Months 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
50561|NCT01313858|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.|Baseline and Months 3, 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
50562|NCT01313858|Primary|Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score|The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH[%] = (Attained score*100)/(2*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.|Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
50563|NCT01313858|Primary|Clinical Global Impression (CGI) Disease Status|"The CGI is a non-disease-specific evaluation of participants' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from 0 (free of complaints) to 10 (strong discomfort). The closer the score to 0, the better the health status."|Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.||Units on a scale||Standard Deviation|Least Squares Mean
50564|NCT01313780|Secondary|Change in Bowel Habits.|The change of bowel habits from baseline (Visit 1) in bowel habits at Week 4 was investigated, and was categorized as ‘improved’, ‘unchanged’, and ‘worsened’.|4 weeks|FAS analysis, but Oxycodone/naloxone group was missed 15 patients data and Oxycodone group was missed 23 patients data.||participants|||Number
50565|NCT01313780|Primary|Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)|Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment .|4weeks|Analysis of FAS: 117.||units on a scale||Standard Deviation|Mean
50566|NCT01313728|Secondary|Facial Tolerance|All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).|Baseline to 2 Weeks|||Scores on a Scale|||Number
50567|NCT01313728|Secondary|Subject Assessment – Tightness|Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
50568|NCT01313728|Secondary|Subject Assessment – Itching|Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
50569|NCT01313728|Secondary|Subject Assessment – Burning/Stinging|Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
50570|NCT01313728|Primary|Expert Grader Assessment - Dryness|Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
50571|NCT01313728|Primary|Expert Grader Assessment - Erythema|Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)||Scores on a Scale|||Number
50572|NCT01313689|Secondary|Mean Health Change Questionnaire (HCQ) Score|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for ‘my health is a great deal better’ to 9 for ‘my health is a great deal worse’ since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. .||Unit on a scale||Standard Deviation|Mean
50573|NCT01313689|Secondary|Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) – and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||unit on a scale||Standard Deviation|Mean
50574|NCT01313689|Secondary|Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.|From the randomization date up to 60 months post the randomization date.|Safety Population. Only those participants with post-OFA treatment HAHA results were analyzed.||Participants|||Number
50575|NCT01313689|Secondary|Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time|Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU). A cycle is defined as the time between one round of treatment until the start of the next round.|Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 30 Month Follow-up Visit|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Gram per liter||Standard Deviation|Mean
50618|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Osteitis.|RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations. The scores can range from 0 to 75, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo. One participant in the placebo group missing a baseline value was not included in the analysis.||units on a scale||Standard Deviation|Mean
50576|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE) of Special Interest|AEs of special interest included cytopenias (neutropenia [decreased neutrophil count], anaemia [decreased hemoglobin], and thrombocytopenia [decreased platelet count]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 28.9 months)|Safety Population||Participants|||Number
50577|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 28.9 months)|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.||Participants|||Number
50578|NCT01313689|Secondary|Duration of Response as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.||Months||95% Confidence Interval|Median
50579|NCT01313689|Secondary|Time to Response as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (Complete Remission[CR], Complete Remission with incomplete bone marrow recovery[CRi], partial response[PR], or nodular PR[nPR]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only responders (CR, CRi, PR, nPR) were included in the analysis. Response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.||Months||95% Confidence Interval|Median
50580|NCT01313689|Secondary|Time to Next Anti-cancer Therapy by Investigator|Time to next therapy is defined as the time from randomization until the start of the next line of treatment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.||Months||95% Confidence Interval|Median
50581|NCT01313689|Secondary|Time to Progression as Assessed by IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.||Months||95% Confidence Interval|Median
50582|NCT01313689|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed, participants who had not died were censored at the date of last contact.||Months||95% Confidence Interval|Median
50583|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the Investigator|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.||Participants|||Number
50584|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.||Participants|||Number
50585|NCT01313689|Secondary|Progression-free Survival (PFS) as Assessed by Investigator|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.||Months||95% Confidence Interval|Median
50586|NCT01313689|Primary|Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.||Months||95% Confidence Interval|Median
50587|NCT01313676|Secondary|Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date|On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.|From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)|ITT-E Population||Participants|||Number
50588|NCT01313676|Secondary|Decline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.|From start date of IP until IP stop date + 1 (assessed up to 4 years)|ITT-E Population||milliliter/year||Standard Error|Least Squares Mean
50589|NCT01313676|Primary|Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date|Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.|From the date of randomization until date of death due to any cause (average of 2 study years)|ITT-E Population||Participants|||Number
50590|NCT01313663|Secondary|Number of Participants With the Indicated Changes From Baseline Value in Lactate Dehydrogenase (LDH)|"Change from Baseline in the laboratory parameter LDH was assessed as decrease to low, change to normal of no change, and increase to high. Participants with missing Baseline values were assumed to have a normal Baseline value. There is no standard normal range for LDH."|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
50847|NCT01311024|Secondary|Carriage Due to Haemophilus Influenzae|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age||||||
50591|NCT01313663|Secondary|Number of Participants With the Indicated Grade Changes From Baseline Grade in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk. Phos.), and Total Bilirubin (TB)|The laboratory parameters AST, ALT, Alk. Phos., and TB were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for any grade increase, increase to Grade 3, and increase to Grade 4. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. AST/ALT: Grade 1, >upper limit of normal (ULN) - 3.0x ULN; Grade 2, >3.0 to 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, not available (NA). Alk. Phos.: Grade 1, >ULN - 2.5x ULN; Grade 2, >2.5 - 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, NA. TB: Grade 1, >ULN - >1.5x ULN; Grade 2, >1.5 - 3.0x ULN; Grade 3, >3.0 - 10.0x ULN; Grade 4, >10.0x ULN; Grade 5, NA.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
50592|NCT01313663|Secondary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Laboratory Parameters|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Lymphocyte count increased: Grade 3, <500 - 200/millimeters cubed (mm^3); <0.5 - 0.2x 10e9/Liters (L); Grade 4, <200/mm^3; <0.2x 10e9/L. Lymphocyte count decreased: Grade 3, >20000/mm^3; Grade 4, NA. Hyperglycemia; Grade 3, >250 - 500 milligrams per deciliter (mg/dL); >13.9 - 27.8 millimoles per Liter (mmol/L); hospitalization indicated; Grade 4, >500 mg/dL; >27.8 mmol/L; life-threatening consequences. Hypophosphatemia (inorganic phosphorus): Grade 3, <2.0 - 1.0 mg/dL, <0.6 - 0.3 mmol/L; Grade 4, <1.0 mg/dL, <0.3 mmol/L, life-threatening consequences.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
50593|NCT01313663|Secondary|Number of Participants With a Increase From Baseline in Bazett's QTc at the Indicated Time Points|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In clinical studies with pazopanib, events of QT prolongation have occurred.|Baseline; Week 6; Week 15; every 9 weeks in the first 6 months; every 12 weeks in the next 6 months; and, after 1 year, every 6 months (up to Study Week 55)|Safety Population||participants|||Number
50594|NCT01313663|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure (BP) were measured. Categories correspond to the following Common Terminology Criteria for Adverse Events (CTCAE) grades: normal, <120/80 millimeters of mercury (mmHg); prehypertension, 120–139/80–89 mmHg, warranting intervention in participants with high risk; stage I hypertension, 140–159/90–99 mmHg, warranting intervention; and stage II hypertension >/=160/100, warranting immediate attentive intervention to prevent acute symptoms. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Participants with a missing Baseline value were assumed to have a Baseline value of <120 for systolic BP (SBP) and <80 for diastolic BP (DBP).|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population||participants|||Number
50595|NCT01313663|Secondary|Number of Participants With Any On-therapy AE (Serious or Non-serious) Leading to Dose Reductions (DRs) or Interruptions/Delays in the Study|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Management of AEs may require DRs/interruptions in study treatment. If necessary, the pazopanib dose should be reduced stepwise by 200 mg at each step. DRs for pemetrexed were 50-75% of prior dose based on the toxicity leading to DR.|From the time the first dose of study treatment was administered until discontinuation of treatment (up to Study Week 55)|Safety Population||participants|||Number
50596|NCT01313663|Secondary|Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. A participant cold have been withdrawn fom study treatment due to an SAE or AE.|From the time the first dose of study treatment was administered until withdrawal from study treatment (up to Study Week 55)|Safety Population||participants|||Number
50597|NCT01313663|Secondary|Average Dose of Pemetrexed for All Cycles, as a Measure of Extent of Exposure|"The average dose of pemetrexed for all cycles, as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The average dose was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population||milligrams per meters squared (m^2)||Standard Deviation|Mean
50619|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Synovitis.|RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations. The scores can range from 0 to 24, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo||units on a scale||Standard Deviation|Mean
50598|NCT01313663|Secondary|Mean Number of Pemetrexed Dosing Cycles, as a Measure of Extent of Exposure|"Duration of therapy/time on study treatment, measured as the mean number of pemetrexed dosing cycles as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The mean number of dosing cycles was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population||number of cycles||Standard Deviation|Mean
50599|NCT01313663|Secondary|Mean Daily Dose, as a Measure of Extent of Exposure|"Mean daily dose, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Mean daily dose was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population||milligrams||Standard Deviation|Mean
50600|NCT01313663|Secondary|Time on Study Treatment (Pazopanib), as a Measure of Extent of Exposure|"Time on study treatment, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Time on study treatment was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population||months||Standard Deviation|Mean
50601|NCT01313663|Secondary|Number of Participants With Any Non-serious On-therapy Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (up to Study Week 55)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.||participants|||Number
50602|NCT01313663|Secondary|Number of Participants (Par.) With the Indicated Best Overall Response|A par. was defined as a responder if s/he sustained a CR (The disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters) that was confirmed after >=28 days. Response was evaluated by an investigator per RECIST, version 1.1. A par. without a post-Baseline assessment was considered a non-responder. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started). To qualify as a best response of SD, a response of SD had to be observed >=12 weeks after randomization. A par. who was not evaluable had no scans at all or did not have a confirmatory scan.|From randomization until the time of the first documented evidence of a confirmed complete response (CR) or partial response (PR) (average of 10 weeks)|ITT Population||participants|||Number
50603|NCT01313663|Secondary|Overall Survival|Overall survival is defined as the interval between the date of randomization and the date of death from any cause.|From randomization until disease progression or death (up to Study Week 78)|The study size (20 participants) and follow up were not adequate to assess overall survival. Participants who had not died at the time of the cut-off for the analysis were to be censored at the date the particpant was last known to be alive.|||||
50604|NCT01313663|Primary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the first documented sign of investigator-assessed (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) disease progression (PD) or death, whichever occurs first. The date of documented PD is the date of lesion evaluation in the case of radiological PD and the date of symptomatic cancer progression in the case of symptomatic progression (radiological confirmation is required). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was to be censored at the last adequate assessment (LAA) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of progression or death, PFS was to be censored at the date of the LAA.|From randomization until the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered||weeks||90% Confidence Interval|Median
50620|NCT01313520|Other Pre-specified|Change From Baseline in DAS28 CRP.|DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of serum CRP. Scores can range from 2-10; with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo||units on a scale||95% Confidence Interval|Least Squares Mean
50848|NCT01311024|Secondary|Carriage Due to Any Pneumococcal Serotype|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age||||||
50605|NCT01313650|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
50606|NCT01313650|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
50607|NCT01313650|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
50608|NCT01313650|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
50609|NCT01313637|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
50621|NCT01313520|Secondary|Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50).|ACR50 requires that both tender and swollen joint counts improve by at least 50% from baseline, as well as a 50% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and CRP.|Baseline and week 14|Participants treated with Infliximab or placebo||percentage of responders||90% Confidence Interval|Number
50610|NCT01313637|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
50611|NCT01313637|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
50612|NCT01313637|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
50613|NCT01313624|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.~Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough~Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set||days||95% Confidence Interval|Median
50614|NCT01313624|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.||units on a scale||Standard Deviation|Mean
50615|NCT01313624|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.||units on a scale||Standard Deviation|Mean
50616|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis.|"DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of CRP. RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations, ranging from 0 to 24 total. RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations, ranging from 0 to 75 total. The individual~endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic."|Baseline and Week 14|Participants treated with Infliximab or placebo||Z-score||95% Confidence Interval|Least Squares Mean
50617|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans.|Clinical disease activity score (DAS28 CRP) is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), Patient Global Assessment of Disease Status (GADP) on a 100 mm visual analog scale (VAS) and concentration of CRP. Ktrans is the volume transfer rate from the blood plasma to the enhancing synovium. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.|Baseline and Week 14|Participants treated with Infliximab or placebo||Z-score||95% Confidence Interval|Least Squares Mean
50622|NCT01313520|Secondary|Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20).|ACR20 requires that both tender and swollen joint counts improve by at least 20% from baseline, as well as a 20% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and C-reactive protein (CRP).|Baseline and week 14|Participants treated with Infliximab or Placebo||percentage of responders||90% Confidence Interval|Number
50623|NCT01313520|Primary|Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans)|Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).|Baseline and week 14|Participants treated with infliximab or placebo||min ^-1||95% Confidence Interval|Least Squares Mean
50624|NCT01313494|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above. Each AE was assessed by the Investigator as either 'related' or 'not related' to study drug.|24 weeks|Safety population, all randomized patients who took at least 1 dose of the trial treatment after randomization.||participants|||Number
50625|NCT01313494|Secondary|Time to Onset of Second Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation – date of first intake of study drug + 1 day. At least 10 days between the stop date of an exacerbation and the start date of the following exacerbation was required for these to be be considered as two separate COPD exacerbations. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population who experienced a second moderate to severe COPD exacerbation.||days||Full Range|Median
50626|NCT01313494|Secondary|Time to Onset of First Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation – date of first intake of study drug + 1 day. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population with at least one moderate or severe exacerbation||days||Full Range|Median
50627|NCT01313494|Secondary|Mean Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|The mean rate of COPD exacerbations per patient per year rate = (number of exacerbations per treatment group/time to study withdrawal per treatment group) * 365. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat||exacerbations per patient per year|||Number
50628|NCT01313494|Secondary|Percentage of Participants With Moderate or Severe COPD Exacerbations|A COPD exacerbation is an event characterised by a worsening in the patient’s baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat||percentage of participants|||Number
50629|NCT01313494|Secondary|Transition Dyspnoea Index (TDI) Total Score at Week 24|"The TDI is a recognized questionnaire to measure dyspnoea (shortness of breath) in patients with COPD. Questions from the TDI were used to assess the 3 components: change in functional impairment, change in magnitude of task and change in magnitude of effort. Transitions or changes from baseline are rated from -3 (major deterioration) to +3 (major improvement), and summed to give a total score ranging from -9 to +9. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables."|Baseline to Week 24|Intent-to-treat population with available data.||units on a scale||Standard Error|Least Squares Mean
50630|NCT01313494|Secondary|Change From Baseline in Use of Rescue Medication|Salbutamol (given by metered dose inhaler and spacer) was used as rescue medication according to the individual needs of a patient. Each use was documented in the patient’s paper diary. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||puffs/day||Standard Error|Least Squares Mean
50631|NCT01313494|Secondary|Change From Baseline in COPD Symptom Scores|Symptoms of chronic bronchitis with respect to cough and sputum production were assessed daily by the patient and recorded in a diary. Symptoms were assessed on a 4-point scale as follows: Cough: 0: no cough; 1: mild cough (at some time during the day); 2: moderate cough (regularly during the day); 3: severe cough (never free of cough or feeling free of need to cough). Sputum production: 0: no sputum production (unnoticeable); 1: mild sputum production (noticeable as a problem); 2: moderate sputum production (frequent inconvenience); 3: severe sputum production (constant problem). Change from Baseline is reported for cough and sputum separately, and for the sum of the 2 scores (range 0 - 6). Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||units on a scale||Standard Error|Least Squares Mean
50632|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percentage of FEV1/FEV6||Full Range|Mean
50633|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percentage of FEV1/FEV6||Full Range|Median
50634|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percent FEV1/FVC||Full Range|Median
50635|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.||percent FEV1/FVC||Full Range|Median
50636|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/minute||Standard Error|Least Squares Mean
50637|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/minute||Standard Error|Least Squares Mean
50638|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
50639|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
50640|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
50641|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
50642|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/second||Standard Error|Least Squares Mean
50643|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters/second||Standard Error|Least Squares Mean
50644|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
50645|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
50646|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator FEV1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.||liters||Standard Error|Least Squares Mean
50647|NCT01313494|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population included all randomly assigned patients who took at least 1 dose of trial treatment after randomization. Patients were assigned to the treatment group based on the treatment to which they were randomly assigned. Only patients with available data at Baseline and with at least 1 post-baseline measurement are included.||liters||Standard Error|Least Squares Mean
50648|NCT01313299|Primary|Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)|MAS scale is used to assess muscle tone using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.|From Baseline (Day 1) to Week 4|Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.||units on a scale||Standard Deviation|Mean
50649|NCT01313299|Secondary|Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)|"DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited).~If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3."|From Baseline (Day 1) to Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed DAS assessment at baseline and week 4.||units on a scale||Standard Deviation|Mean
50650|NCT01313299|Secondary|Physician's Global Assessment (PGA) of Treatment Response|PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved).|At Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4||units on a scale||Standard Deviation|Mean
50651|NCT01313273|Secondary|Reduction in Chromogranin A Serum Levels||Baseline, Week 96|Study early terminated due to poor enrollment|||||
50652|NCT01313273|Secondary|Median Time to PSA Response||Week 96|Study early terminated due to poor enrollment|||||
50653|NCT01313273|Secondary|Prostate Specific Antigen (PSA) Response||Week 96|Study early terminated due to poor enrollment|||||
50654|NCT01313273|Primary|Progression-free Survival||Week 96|Study early terminated due to poor enrollment.|||||
50655|NCT01313221|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard.|32 weeks|Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.||participants|||Number
50656|NCT01313221|Secondary|Health Resource Utilization: Ability to Perform Daily Activities|Participants were asked: How much did your psoriasis affect your ability to do your daily activities or household chores? Possible answers were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.||participants|||Number
50657|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Missed Hours From Work|Participants who were employed answered the following question regarding the past 4 weeks: How many hours per week did you miss from work because of your psoriasis? The number of participants with one or more missed hours of work per week is reported.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data; LOCF was used.||participants|||Number
50658|NCT01313221|Secondary|Health Resource Utilization: Productivity While Working|Participants who were employed were asked: How much did your psoriasis affect your productivity while you were working? Possible responses were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data at each time point; LOCF was used. For the Etanercept 50 mg BIW group there were 106 and 100 participants with available data at Baseline and Week 24 respectively. For the Etanercept + Topical group there were 93 and 85 participants respectively.||participants|||Number
50659|NCT01313221|Secondary|Health Resource Utilization: Employment Status|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants were asked their employment status at Baseline and at Week 24.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.||participants|||Number
50660|NCT01313221|Secondary|Health Resource Utilization: Out of Pocket Expenses|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess out of pocket expenses, participants answered the following question regarding the past 4 weeks: Not counting study mandated visits, what out-of-pocket expenses did you spend for the management of psoriasis (i.e. costs due to travelling to doctor appointment, hospital or clinic parking costs, alternative medications)?|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||Canadian dollars||Inter-Quartile Range|Median
50661|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Who Needed Friend or Family Care|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants answered the following question regarding the past 4 weeks: How many hours have you had a friend or family member take time off work to provide care or transportation? The number of participants who had paid or non-paid help for one or more hours is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
50662|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Requiring Paid Help With Chores|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of participants who needed paid help with chores, participants answered the following question regarding the past 4 weeks: How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)? The number of participants who paid for help one or more times is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
50663|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Home Healthcare Visits|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of homecare visits, participants answered the following question regarding the past 4 weeks: How many times have you received care from a health professional in your home? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
50664|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician’s office or urgent care clinic? How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.||participants|||Number
50665|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24|The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.|Baseline and Weeks 12 and 24|Full analysis set; LOCF was used; n indicates the number of patients with available data for each scale at each time point.||units on a scale||Standard Deviation|Mean
50666|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24|TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable with available data; n indicates the number of patients with available data for each scale.||units on a scale||Standard Error|Least Squares Mean
50667|NCT01313221|Secondary|Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.|Baseline and Week 12 and Week 24|Full analysis set with available data; LOCF was used||units on a scale||Standard Deviation|Mean
50668|NCT01313221|Secondary|Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set with available data||units on a scale||Standard Error|Least Squares Mean
50669|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments.~Change from Baseline \ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement."|Baseline and Weeks 12, 16, 20, and 24|Full analysis set with available data; LOCF was used||percent change||Standard Deviation|Mean
50670|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement.~Change was adjusted for treatment using a mixed model."|Weeks 12, 16, 20, and 24|Efficacy analysis set with available data||percent change||Standard Error|Least Squares Mean
50671|NCT01313221|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is completed by the same blinded assessor performing the PASI assessments and is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Weeks 12, 16, 20, and 24|Full Analysis Set, LOCF was used.||percentage of participants||95% Confidence Interval|Number
50672|NCT01313221|Secondary|Percentage of Participants With a PASI 90 Response|The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.||percentage of participants||95% Confidence Interval|Number
50673|NCT01313221|Secondary|Percentage of Participants With a PASI 75 Response|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.||percentage of participants||95% Confidence Interval|Number
50674|NCT01313221|Secondary|Percentage of Participants With a PASI 50 Response|The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.||percentage of participants||95% Confidence Interval|Number
50675|NCT01313221|Secondary|Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.|Baseline and Weeks 12, 16, 20, and 24|Full analysis set, (all enrolled participants who had taken at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation) and with available data. Last Observation Carried Forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
50676|NCT01313221|Secondary|Percent Change in PASI From Week 12 to Weeks 16 and 20|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12, Week 16 and Week 20|Efficacy Evaluable set with available data at each time point (indicated by n)||percent change||Standard Error|Least Squares Mean
50690|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50677|NCT01313221|Primary|Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value * 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set, which included all randomized participants who had taken at least 1 dose of study drug and had at least 1 post-randomization efficacy evaluation, and with available data at Week 12 and Week 24.||percent change||Standard Error|Least Squares Mean
50678|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50679|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50680|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50681|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50682|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50699|NCT01313208|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point|The HAQ-DI asks about the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each functional area are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
50683|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50684|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). Sleep Disturbance measures the ability to fall asleep and to maintain restful sleep. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50685|NCT01313208|Secondary|Participant Assessment of Fatigue at Each Time Point|The participant's assessment of fatigue was collected using a single-item 100 mm visual analogue scale. The participant was asked to draw a vertical line through a horizontal line to indicate the degree of fatigue they experienced because of their condition over the past week. The horizontal line is 100 mm in length with ‘0’ and ‘no fatigue’ on the left end of the line and ‘100’ and ‘extreme fatigue’ on the right end of the line. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50686|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."||percent overall work impairment||Standard Error|Least Squares Mean
50687|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis. Percent activity impairment is derived from the patient’s assessment of the degree to which rheumatoid arthritis affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||percent activity impairment||Standard Error|Least Squares Mean
50688|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."||percent impairment while working||Standard Error|Least Squares Mean
50689|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to rheumatoid arthritis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."||percent work time missed||Standard Error|Least Squares Mean
50700|NCT01313208|Secondary|Physician Global Assessment of Disease Activity at Each Time Point|The global assessment of the participant’s arthritis was assessed by the physician circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
50691|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50692|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50693|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50694|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50695|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50696|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50697|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The physical functioning subscale assesses limitations in physical activities because of health problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Error|Least Squares Mean
50698|NCT01313208|Secondary|C-reactive Protein Levels at Each Time Point|C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||mg/L||Standard Deviation|Mean
50701|NCT01313208|Secondary|Patient's Global Assessment of Disease Activity at Each Time Point|The participant’s global assessment of their arthritis disease activity was assessed by the participant circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
50702|NCT01313208|Secondary|Patient Global Assessment of Joint Pain at Each Time Point|"The severity of the participant’s joint pain was assessed using a visual analog scale (VAS). The participant was asked to draw a mark through a 100 mm horizontal line to indicate how much pain they were experiencing “today, from ‘0’ (no pain at all) on the left end of the line to 100 (worst pain imaginable) on the right end of the line."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
50703|NCT01313208|Secondary|Swollen 28-Joint Count (SJC28) at Each Time Point|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||swollen joints||Standard Deviation|Mean
50704|NCT01313208|Secondary|Tender 28-Joint Count (TJC28) at Each Time Point|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||tender joints||Standard Deviation|Mean
50705|NCT01313208|Secondary|Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:~28 tender joint counts,~28 swollen joint counts,~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and~C-reactive protein (CRP) in mg/dL.~The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
50706|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point|The simplified disease activity index (SDAI) is a composite measure that sums the total number of: - 28 tender joint counts, - 28 swollen joint counts, - Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest, and - C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI low disease activity is defined as a score ≤ 11.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
50707|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Remission at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:~28 tender joint counts,~28 swollen joint counts,~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0= lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and~C-reactive protein (CRP) in mg/dL.~The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI remission is defined as a score ≤ 3.3."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
50708|NCT01313208|Secondary|Clinical Disease Activity Index (CDAI) Score at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest).~The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||scores on a scale||Standard Deviation|Mean
50709|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
50710|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Remission at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. CDAI remission is defined as a score ≤ 2.8."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
50711|NCT01313208|Secondary|Percentage of Participants Achieving Count Remission at Each Time Point|"Count remission is achieved when a participant satisfies all of the following at any given time point: - 68 tender joint count ≤ 1, - 66 swollen joint count ≤ 1, - C-reactive protein (CRP) (in mg/dL) ≤1, and - patient global assessment of disease activity ≤ 1 (measured on a likert scale from 0 to 10 ranging from no activity at all to worst activity imaginable)."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
50721|NCT01313182|Secondary|Measure Adverse Events Related to Mupirocin and Povidone-iodine.|Patients were given an adverse event log to complete after treatment|At time of treatment||||||
50712|NCT01313208|Secondary|Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point|"The Multi-Dimensional Health Assessment Questionnaire (MDHAQ) is adapted from the standard HAQ and is used for the computation of the Routine Assessment of Patient Index Data 3 (RAPID3). The RAPID 3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do) and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10, both scored 0 (best) to 10 (worst). The three 0-10 scores for physical function, pain, and global assesment of health are added together for a composite score of 0 to 30. The RAPID3 composite score includes 4 categories: High Severity > 12, Moderate Severity = 6.1 - 12, Low severity = 3.1 - 6, and Remission ≤ 3."|Baseline and Weeks 4, 12, and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
50713|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
50714|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
50715|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-Reactive Protein level.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
50716|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at All Other Timepoints|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP)~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero to ten. A DAS28 above 5.1 indicates high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."||percentage of participants|||Number
50717|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-Reactive Protein (CRP) level~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analysis at each time point."||percentage of participants|||Number
50718|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at Week 12|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP)~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity."|Week 12|Primary analysis set; LOCF was used||percentage of participants|||Number
50719|NCT01313208|Primary|Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Week 12|Primary analysis set (all randomized participants); last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
50720|NCT01313182|Secondary|Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.|Lab will culture isolates when time and money permit|Isolates collected and frozen||||||
50724|NCT01313117|Secondary|Total Neuropathy Score (TNS)|The Total Neuropathy score (TNS) is a validated score that combines signs, symptoms, and very limited nerve conduction studies (NCS). It was designed to assess peripheral nerve function and has been used as an endpoint in clinical trials of toxic neuropathy. The TNS is a composite scale with a range of values from 0 (normal) to 28 (severely affected). It includes data from 7 different categories. Patients are asked to assess the severity of sensory symptoms on a scale of 0 (no symptoms) to 4 (symptoms above knees or elbows, or functionally disabling). Next, 4 examination categories are assessed. These include pin sensation, vibration sensation, deep tendon reflexes, and strength. Signs are scored from 0 to 4 depending on severity. The nerve conduction portion of the scale consists of measurements of a motor (peroneal) and sensory (sural) nerve. Motor and sensory responses are graded on a scale of 0 to 4 depending on the severity of an abnormality.|4 months|Failure to reach the MTD precluded our ability to perform any meaningful analysis of the TNS.|||||
50725|NCT01313117|Secondary|Cumulative Rate of Adverse Events||4 months|||participants|||Number
50726|NCT01313117|Secondary|Proportion of Patients Who Complete the Proposed Regimen of Daily ALA||4 months|||participants|||Number
50727|NCT01313117|Primary|Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile|Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.|4 months|Although our dose finding analysis suggested a maximum tolerated dose of 500mg daily, it should be noted that we failed to fully complete the Continual Reassessment Method (CRM) dose finding portion of the study. As such, we can not make confident dose finding statements on the basis of this trial.||mg|||Number
50728|NCT01313078|Primary|Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|11 months, 25 days|||Participants|||Number
50729|NCT01313078|Primary|6 Month Progression Free Survival|Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as >20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.|6 months|||Participants|||Number
50730|NCT01313039|Secondary|In Vitro Tamoxifen Response in Tumors|To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.|2 years||||||
50731|NCT01313039|Secondary|Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer|To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.|2 years||||||
50732|NCT01313039|Secondary|Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer|To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.|2 Years||||||
50733|NCT01313039|Primary|Increase of ER Protein Expression in ER-Negative/Low Breast Cancer|"To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the ER response rate by both standard immunohistochemistry and Allred Score."|2 years|Only 1 subject had evaluable study data||participants|||Number
50734|NCT01312948|Secondary|Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask|Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the patients usual mask|>4 hours monitored sleep study|Analysis was as per protocol||apnea hypopnoea index||Standard Deviation|Mean
50735|NCT01312948|Primary|Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask|"Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask.~Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability."|8 nights use|Analysis was as per protocol||units on a scale||Standard Deviation|Mean
50736|NCT01312818|Secondary|Number of Subjects With Activated Caspases and Other Regulators of Apoptosis|Activation of caspases and other regulators of apoptosis in treated blast cells will be determined by Western analysis (correlative lab analysis).|From Day 1 to 30 Days After Last Dose|The trial was terminated early with only 2 patients so caspase samples were not sent for analysis.|||||
50737|NCT01312818|Secondary|Number of Subjects Experiencing Drug Related Adverse Events|To characterize the toxicities of bortezomib, vorinostat and dexamethasone when used in combination. Toxicity will be graded using the NCI’s Common Terminology Criteria for Adverse Events (CTCAE 4.0).|Day 1 of Treatment to 30 Days Post Treatment|||participants|||Number
50738|NCT01312818|Primary|Number of Subjects Who Achieved Complete Remission of Their Disease|Complete Remission (CR): A CR requires that the following be recorded concurrently: an absolute neutrophil count (segs and bands) > 1000/μL, no circulating blasts, platelets > 100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and < 5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent. If patients continue on with treatment, there can be no evidence of recurrence of ALL for at least 4 weeks.|Day 30|||participants|||Number
50739|NCT01312805|Primary|Diagnosis Rate of Asthma||one year|||Participants|||Count of Participants
50740|NCT01312766|Secondary|Live Birth Rate||9 months after treatment|||percentage of participants|||Number
50741|NCT01312766|Secondary|Number of Cleaved Embryos||two days after insemination|||embryos||Standard Deviation|Mean
50742|NCT01312766|Secondary|Total Number of Inseminated Oocytes (IVF and ICSI)|number of oocytes that were inseminated via IVF or injected via ICSI technique.|on the day of oocyte retrieval|||oocytes||Standard Deviation|Mean
50743|NCT01312766|Secondary|Ratio Mature/Total Number of Oocytes Retrieved.|Percentage of retrieved oocytes considered to be mature.|at the end of the stimulation.|||percentage of total oocytes retrieved|||Number
50744|NCT01312766|Secondary|Number of Mature (Grade III Metaphase II) Oocytes Retrieved.||at the end of the stimulation.|||oocytes||Standard Deviation|Mean
50750|NCT01312766|Secondary|Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)|Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.|up to 28 days after treatment start|The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer.||percentage of participants|||Number
50751|NCT01312766|Secondary|Mean hMG Dose (Total);||up to 22 days after treatment start|||Internationa Units (IU)||Standard Deviation|Mean
50752|NCT01312766|Primary|Total Number of Oocytes Retrieved||up to 24 days after treatment start|||number of oocytes||Standard Deviation|Mean
50753|NCT01312519|Secondary|Time Necessary to Perform the Bone Marrow Procedure|The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.|Day 1 needle insertion through needle removal|Per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.||seconds||Standard Deviation|Mean
50754|NCT01312519|Primary|Subject Reported Level of Pain During Procedure|Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.|Day 1 during the needle insertion|as per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.||units on a scale||Standard Deviation|Mean
50755|NCT01312467|Secondary|Safety and Tolerability of Metformin Hydrochloride Treatment|"All participants will be evaluable for toxicity from the time of their first dose of metformin. Since toxicities in this study are measured as categorical data, primary analysis shall be by tests of binomial proportions (e.g., Mantel-Haenszel chi-squared statistic). This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting.~We are in the process of identifying and securing funding to complete the secondary and tertiary endpoints. Once the information is available, we will provide those results with any relevant post-hoc analyses."|Up to 16 weeks||||||
50756|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Serum (Fasting and 2 Hour Postprandial Insulin and Glucose, Fasting IGF-1, IGFBP-1, IGFBP-3, Leptin, Adiponectin and Metformin Levels)|We are in the process of identifying and securing funding to complete the secondary and tertiary endpoints. Once the information is available, we will provide those results with any relevant post-hoc analyses.|Up to 16 weeks||||||
50757|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Colorectal Mucosa Proliferation (Ki-67, Phosphorylated IGF-1 Receptor, Phosphorylated Insulin Receptor, Phosphorylated AKT, Phosphorylated mTOR, and Phosphorylated AMP Kinase)|We are in the process of identifying and securing funding to complete the secondary and tertiary endpoints. Once the information is available, we will provide those results with any relevant post-hoc analyses.|Up to 16 weeks||||||
50758|NCT01312467|Primary|Change in Activated S6serine235 (i.e., the Ratio of pS6serine235/S6serine235)|Tissue S6Ser235 immunostaining was analyzed by the study pathologist using Histo Score (HScore) analysis at baseline and post- metformin (Week 12). The Hscore is determined by estimation of the percentage of cells positively stained with mild, moderate, or strong staining intensity. The final score is determined by weighted estimate, as follows: Hscore = (# cell stained with High intensity/total # cells)x3 + (# cells stained with median intensity/total # cells)x2 + (# cells stained with low intensity/total # cells)x1. Mean and standard deviation of the change in the histo score (H score) of pS6serine235 from baseline were calcuated.|From baseline to 12 weeks|The analysis is based on 32 participants who have evaluable data.||weighted ratio of staining cells||Standard Deviation|Mean
50759|NCT01312428|Secondary|To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up||||||
50760|NCT01312428|Primary|To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up|The study was terminated early, therefore, primary or secondary measures were not assessed.|||||
50761|NCT01312272|Secondary|Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score|"This is a frequently used instrument, initially developed by Kay, Opler, and Fiszbein, that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. It will be used to compare the psychopathology between the two treatment groups.~The maximum Total Score on the scale is 210 and the minimum score is 30, with higher values indicating more severe symptoms. The maximum scale of 210 is the sum of the scores from each symptom category (positive symptoms = range 7 to 49; negative symptoms = range 7 to 49; general psychopathology = range to 16 to 112).~Our outcome measure refers to the change in the PANSS Total Score. A greater decrease on the scale indicates greater improvement in symptoms (e.g., a participant with a change score of -20 improved more on the PANSS than a participant with a change score of -5)."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||change in units on scale||Standard Deviation|Mean
50762|NCT01312272|Secondary|Facial Affect Recognition (Low Level Social Cognition)|Participants are asked to identify facial expressions of emotion in still photographs from the standardized stimulus set developed by Ekman. The test includes digitized color photos of eight different posers displaying facial expressions of six basic emotions plus neutral expressions. On each trial, a photo and a list of the seven possible expressions are simultaneously presented on the screen. The participant verbally identifies the emotion he/she believes is correct and the experimenter enters the response. The dependent measure is the total number correct.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
50763|NCT01312272|Secondary|Social Perception Assessment (Low Level Social Cognition)|We will assess social perception using the Half-Profile of Nonverbal Sensitivity (Half-PONS). Brief scenes are shown that include facial expressions, voice intonations, and/or body gestures. Subjects select a label that best describes the situation. The dependent measure is the total number of correct labels.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
50764|NCT01312272|Secondary|Empathy|Empathy was assessed using the Emotional Perspective Taking Task (EPTT) (Derntl et al., 2009). In this task, subjects are presented with 60 digital images depicting two individuals in a social interaction, with one individual's face masked. Subjects are asked to infer the emotional expression of the masked face, selecting between two choices. Scenes portray 5 basic emotions as well as neutrality and each image is displayed for 4 s each.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
50765|NCT01312272|Secondary|Theory of Mind Assessment (High Level Social Cognition)|The Awareness of Social Inference Test (TASIT Part III: Social Inference – Enriched) will be administered to assess theory of mind.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
50766|NCT01312272|Primary|Social Cognition Composite Measure|"Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two high-level measures and two low-level measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)|||Change in z-score||Standard Deviation|Mean
50767|NCT01312129|Primary|% BOLD Response Increase Above Baseline|Test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). BOLD response refers to brain activation in response to the presence of oxygen in a particular part of the brain. To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment. During the fMRI scan session, participants will be presented with the alcohol cue task. We will compare the difference in BOLD response during the presence of alcohol vs. a novel substance during the alcohol cue task. Outcome data collected during the alcohol cue task will provide us with BOLD response data for each intervention period. We will analyze the outcome data using FSL (Oxford Centre for Functional MRI of the Brain (FMRIB) Software – a collection of functional and structural brain image analysis tools).|Over two weeks|||% BOLD Response increase above baseline||Standard Deviation|Mean
50768|NCT01312038|Primary|Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)|The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow|After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment|ears pre-treatment/ears post-treatment||ratio|Participants|Standard Deviation|Mean
50769|NCT01311687|Secondary|Time to First Worsening of Quality of Life (QOL) Domains|"Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following:~For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM.~For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM.~See previous outcome measures for definitions of each scale."|Assessed on Day 1 of the first 6 treatment cycles.|PRO population||days||95% Confidence Interval|Median
50770|NCT01311687|Primary|Progression-free Survival (PFS) With a Later Cut-off Date|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl);~Urine M-component (absolute increase ≥ 200 mg/24 hours);~Bone marrow plasma cell percentage (absolute % ≥ 10%);~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks.|Intent-to-treat population||weeks||95% Confidence Interval|Median
50771|NCT01311687|Secondary|Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score|EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals “perfect health”, a score of 0 equals “death” and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
50772|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain|"The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).~The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
51373|NCT01304589|Secondary|Coital Pain|Intercourse pain is measured by completing a daily diary|18 weeks|22 subjects were assigned to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes the 18 eligible subjects who completed all of the study visits.||units on a scale||Standard Deviation|Mean
50773|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms|"The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).~The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
50774|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
50775|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
50776|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
50777|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
50778|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"The Patient Reported Outcomes (PRO) study population includes any intent-to-treat study participants with 1 active treatment and 1 PRO measurement item completed. Only participants with available data at Baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
50779|NCT01311687|Secondary|Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|"Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score.~The categories of the ECOG Performance Status Scale are as follows:~0: Fully active, able to carry on all pre-disease performance without restriction;~1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work;~2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.~Patients with a score of 3, 4 or 5 were excluded from participating in the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in ECOG performance status during the study||weeks||Full Range|Median
50780|NCT01311687|Secondary|Time to Improvement in Renal Function|"Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function.~Renal Function was categorized as (from best to worst):~Normal: creatinine clearance ≥80 mL/min;~Grade 1: creatinine clearance ≥60 to <80 mL/min;~Grade 2 : creatinine clearance ≥45 to < 60 mL/min.~Participants with creatinine clearance < 45 mL/min at baseline were be excluded from the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in renal function||weeks||Full Range|Median
50781|NCT01311687|Secondary|Time to Improvement in Bone Pain|"Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category.~Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, “Have you had bone aches or pain?”:~Not at all,~A little,~Quite a bit, or~Very much."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in bone pain||weeks||Full Range|Median
50782|NCT01311687|Secondary|Time to the First Hemoglobin Improvement|"Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are:~Normal;~CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL;~CTCAE Grade 2: < 10.0 to <8.0 g/dL.~Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in hemoglobin during the study||weeks||Full Range|Median
50783|NCT01311687|Secondary|Duration of Response|Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population||weeks||95% Confidence Interval|Median
50784|NCT01311687|Secondary|Time to Response|"Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population||weeks||Full Range|Median
50785|NCT01311687|Secondary|Time to Progression|"Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG).~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl);~Urine M-component (absolute increase ≥ 200 mg/24 hours);~Bone marrow plasma cell percentage (absolute % ≥ 10%);~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population||weeks||95% Confidence Interval|Median
50786|NCT01311687|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria|"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee:~CR requires all of the following:~Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.~<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.~No increase in size or number of lytic bone lesions.~Disappearance of soft tissue plasmacytomas.~PR requires all of the following:~≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.~Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days.~For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days.~≥ 50% reduction in the size of soft tissue plasmacytomas.~No increase in size or number of lytic bone lesions."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population||percentage of participants|||Number
50787|NCT01311687|Secondary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria|"Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee:~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population||percentage of participants|||Number
50788|NCT01311687|Secondary|Overall Survival With a Later Cut-off Date|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks.|Intent-to-treat||weeks||95% Confidence Interval|Median
50789|NCT01311687|Secondary|Overall Survival|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks.|Intent-to-treat||weeks||95% Confidence Interval|Median
50790|NCT01311687|Secondary|Number of Participants With Adverse Events (AEs)|"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:~Results in death;~Is life-threatening;~Requires or prolongs existing inpatient hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Constitutes an important medical event.~The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):~Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death."|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 01 March 2013. Maximum time on treatment was 93 weeks.|Safety population (all randomized participants who received at least one dose of study drug (either Pomalidomide or Dexamethasone)).||participants|||Number
50791|NCT01311687|Primary|Progression-free Survival (PFS)|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl);~Urine M-component (absolute increase ≥ 200 mg/24 hours);~Bone marrow plasma cell percentage (absolute % ≥ 10%);~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks.|Intent-to-treat population||weeks||95% Confidence Interval|Median
50792|NCT01311661|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event reporting includes 12 days into the subsequent washout or post-treatment period.|3 weeks + 12 days|Treated set||Participants|||Number
50793|NCT01311661|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 3-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|3 weeks|FAS||Units on a scale||Standard Error|Mean
50794|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS||Number of patients|||Number
50795|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment .|0-3 weeks|FAS||Number of patients|||Number
50796|NCT01311661|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS||Number of patients|||Number
50797|NCT01311661|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM3 device.|0-3 weeks|FAS||Percentage of asthma symptom free days||Standard Error|Mean
50798|NCT01311661|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM3 device (overall mean number obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Puffs||Standard Error|Mean
50799|NCT01311661|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||mL||Standard Error|Mean
50800|NCT01311661|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||mL||Standard Error|Mean
50801|NCT01311661|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Percentage||Standard Error|Mean
50802|NCT01311661|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Liter/min||Standard Error|Mean
50803|NCT01311661|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS||Liter/min||Standard Error|Mean
50804|NCT01311661|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 PEF values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
50805|NCT01311661|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
50806|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
50807|NCT01311661|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
50808|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS||Liter/sec||Standard Error|Mean
50809|NCT01311661|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FVC values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50810|NCT01311661|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post-dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50811|NCT01311661|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50812|NCT01311661|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50813|NCT01311661|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50814|NCT01311661|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
51374|NCT01304589|Secondary|Tampon Pain|"Subjects completed a tampon insertion pain test once a week in their daily diary. The values were averaged and compared pre-treatment versus post-treatment."|18 weeks|22 subjects were eligible and received study medication. Analysis population includes all 22 eligible subjects.||units on a scale||Standard Deviation|Mean
50815|NCT01311661|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50816|NCT01311661|Secondary|FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50817|NCT01311661|Secondary|FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS||Liter||Standard Error|Mean
50818|NCT01311661|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.||Liter||Standard Error|Mean
50819|NCT01311557|Secondary|Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
50820|NCT01311557|Secondary|Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
50821|NCT01311557|Secondary|Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine|Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.|Day 0 (pre-vaccination) and 30 days post-vaccination|Seroprotection rates were assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
50822|NCT01311557|Primary|Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were > 2.56 EU/mL for diphtheria or > 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.|30 days post-vaccination|Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
50823|NCT01311557|Primary|Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.|30 days post-vaccination|Anti-pertussis booster response were assessed in the Per-protocol Analysis Set.||Percentage of participants|||Number
50824|NCT01311557|Primary|Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
50825|NCT01311505|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.||participants|||Number
50826|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Respiratory Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since respiratory rate remained within normal limits throughout the study and there were no significant deviations from baseline.||respirations/minute||Standard Deviation|Mean
50827|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Oral Temperature|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since oral temperature remained within normal limits throughout the study and there were no significant deviations from baseline.||Degrees Celsius||Standard Deviation|Mean
50828|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Pulse Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since pulse rate remained within normal limits throughout the study and there were no significant deviations from baseline.||beats per minute||Standard Deviation|Mean
50829|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Supine Blood Pressure (BP)|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since supine systolic and diastolic BP remained within normal limits throughout the study and there were no significant deviations from baseline.||millimeters of mercury (mmHg)||Standard Deviation|Mean
50830|NCT01311505|Other Pre-specified|Number of Participants With Abnormal Safety Laboratory Test Values|Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.|Screening and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.||participants|||Number
50831|NCT01311505|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC [0-∞] minus AUC[0-10])*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Percent AUC||Geometric Coefficient of Variation|Geometric Mean
50832|NCT01311505|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hrs||Standard Deviation|Mean
50833|NCT01311505|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
50834|NCT01311505|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hrs||Full Range|Median
50835|NCT01311505|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
50836|NCT01311505|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||microgram*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
50837|NCT01311362|Primary|Cmax of Ambrisentan||after first dose, at steady-state and during St John's wort|||ng/ml||95% Confidence Interval|Geometric Mean
50838|NCT01311362|Primary|AUC of Ambrisentan||after first dose, at steady-state, during St John's wort|||h*ng/ml||95% Confidence Interval|Geometric Mean
50839|NCT01311102|Primary|Pain During IUD Placement|"IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Immediately after IUD placement|||units on a scale of 0-9||Standard Deviation|Mean
50840|NCT01311102|Primary|Pain Measurement During Liquid Infusion/Sounding|"After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Recorded at the end of the infusion|||units on a scale of 0-9||Standard Deviation|Mean
50841|NCT01311102|Primary|Pain During Tenaculum Placement|"Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being no pain and 9 being worst pain in life. Taken to adjust for different pain thresholds among subjects"|Immediately following tenaculum placement|||units on a scale of 0-9||Standard Deviation|Mean
50842|NCT01311102|Primary|Pain Scores During Overall IUD Placement|"Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being no pain and 9 being worst pain in life."|Before patient left the examination room at conclusion of procedure|||units on a scale of 0-9||Standard Deviation|Mean
50843|NCT01311024|Secondary|Outpatient Antibiotic Treatment|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
50844|NCT01311024|Secondary|Tympanostomy Tube Surgery|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years||||||
50849|NCT01311024|Primary|Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules|Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age|||percentage of subjects|||Number
50850|NCT01310855|Secondary|Safety and Tolerability||from date of randomisation to death||||||
50851|NCT01310855|Secondary|Time to Deterioration of Neurological Status||from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first.||||||
50852|NCT01310855|Secondary|Steroid Use||from randomization to first increase in dexamethasone dose||||||
50853|NCT01310855|Secondary|Progression-free Survival Rate at 6 Months||from the date of randomisation to 6 months||||||
50854|NCT01310855|Secondary|Radiographic Response Rate||from baseline scan to six week and 12 week scans||||||
50855|NCT01310855|Secondary|Overall Survival||from date of randomization to date of Death due to any cause.||||||
50856|NCT01310855|Primary|Progression-free Survival|"Progression free survival (PFS) defined as the time from the date of randomisation to the date of first progression or death due to any cause, whichever one comes first.~The progression definition will be based on modified RANO criteria (Wen 2010), such that progression will be defined as the earliest time that at least one of the following occurs:~Clinical deterioration~Failure to return for evaluation as a result of death or deteriorating condition~Or, by retrospective radiographic central review:~Any new lesion~Increase in ≥25% of sum of the products of perpendicular diameters of enhancing lesions compared with baseline scan, on stable or increasing doses of steroids (dexamethasone) compared to baseline (T1 post-contrast scan)~Clear progression of non-measureable disease~Significant increase in T2/FLAIR non-enhancing lesion – on stable or increasing steroids (dexamethasone) compared with baseline or best response not caused by co-morbid events."|from the date of randomisation to the date of first progression or death due to any cause|||months||90% Confidence Interval|Median
50857|NCT01310803|Secondary|To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder|The occurrence of serious adverse events (SAEs), occurrence of local adverse reactions (LARs), results of vital signs, physical exams and laboratory test, and study discontinuation due to inability to complete valrubicin instillations|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.|||||
50858|NCT01310803|Primary|To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder.|time interval from randomization to an event. An event is defined as tumor recurrence (any stage or grade), tumor progression to muscle-invasive bladder cancer (MIBC), metastatic bladder cancer or death from any cause, whichever occurs first. Tumor recurrence or progression must be documented by biopsy/transurethral resection of bladder tumor (TURBT).|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.|||||
50859|NCT01310777|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|The intent-to-treat (ITT) analysis set included all subjects who received study drug and completed at least 1 scheduled on-therapy study visit.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
50860|NCT01310582|Secondary|Time to Discharge From PACU||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU|||Minutes||Standard Deviation|Mean
50861|NCT01310582|Primary|Time to Opening of Eyes||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery|||seconds||Standard Deviation|Mean
50862|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50863|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.|During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50874|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50864|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50865|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50866|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50867|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50868|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50869|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50870|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50871|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50872|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50873|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
51227|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat|Means for the change from baseline to follow-up visit 2|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis||units on a scale||Standard Deviation|Mean
50875|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50876|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50877|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50878|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50879|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50880|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.|From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50881|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50882|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50883|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50884|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50885|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50886|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C.|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50887|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50888|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subject|||Number
50889|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, solely on subjects with results available/accessible.||Subject|||Number
50890|NCT01310413|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.|At Day 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.||Subject|||Number
50891|NCT01310413|Secondary|Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.||At Days 0 and 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.||Subject|||Number
50892|NCT01310413|Secondary|Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.|At Days 0, 42, 182 and 385|Analysis was done on the Day 42, 182 and 385 ATP cohorts for immunogenicity, that is, 50 percent of the evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0, 42, 182 and 385 time points.||Titer||95% Confidence Interval|Geometric Mean
50893|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 385.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available||Fold increase||95% Confidence Interval|Geometric Mean
50894|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 385|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available||Subjects|||Number
50895|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Subjects|||Number
52483|NCT01292135|Secondary|Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants|||Number
50896|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Titer||95% Confidence Interval|Geometric Mean
50897|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available||Ratio||95% Confidence Interval|Geometric Mean
50898|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available||Subject|||Number
50899|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Titer||95% Confidence Interval|Geometric Mean
50900|NCT01310413|Secondary|Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 182|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Subject|||Number
50901|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385."|At Day 0 and Day 182.|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Titre||95% Confidence Interval|Geometric Mean
50902|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Days 21 and 42|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Ratio||95% Confidence Interval|Geometric Mean
51318|NCT01305473|Secondary|Procedural Time for Sepramesh Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|Day 0|All enrolled subjects were included in the analysis.||minutes||Standard Deviation|Mean
50903|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|"A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Days 21 and 42|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.||Subject|||Number
50904|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Subject|||Number
50905|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Titer||95% Confidence Interval|Geometric Mean
50906|NCT01310413|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.||Subject|||Number
50907|NCT01310400|Secondary|Safety: Incidence of Solicited and Unsolicited Adverse Events|Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.|Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end|||percentage of subjects with AEs|||Number
50908|NCT01310400|Secondary|Seroprotection|Seroprotection rate, defined as a post-vaccination HI titer of 1:40.|3 weeks after the 2nd vaccination|||percentage seroprotected subjects||95% Confidence Interval|Number
50909|NCT01310400|Secondary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value|3 weeks after the 2nd vaccination|||Fold (ratio)|||Number
50910|NCT01310400|Primary|Immunogenicity, Assessed by the Haemagglutination (HI) Test|Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.|3 weeks after the 2nd vaccination|According-to-protocol population: subjects who received both doses of influenza vaccine, with available pre- and post-vaccination titers and without major protocol violations||percentage of participants||95% Confidence Interval|Number
50911|NCT01310179|Secondary|Treatment Outcome and Percent Change in Tumor Volume|Measurement of tumor response to study drug, as measured by the percentage of change in tumor volume as measured by a physicial measurement using a ruler|Entry through Study Day 56|||participants|||Number
50912|NCT01310179|Primary|Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|Entry through Study Day 56|||participants|||Number
50913|NCT01310127|Primary|Macular Volume|Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength|6 weeks|||mm cubed||Standard Deviation|Mean
50914|NCT01310127|Primary|OCT Retinal Thickness|Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.|Week 6|||micrometers cubed||Standard Deviation|Mean
50915|NCT01310127|Primary|Summed Ocular Inflammation Score (SOIS)|An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).|Week 6|||units on a scale||Standard Deviation|Mean
50916|NCT01310127|Primary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities|ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.|Week 6|||letters||Standard Deviation|Mean
50917|NCT01309997|Secondary|Percentage of CD27+ B Cells in Responders (SCR) and Non-responders|%CD27+ B cells|6 months|||percentage of CD27+ B cells||Full Range|Mean
50918|NCT01309997|Secondary|Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale|Maximum of 10 body areas. Each area can be graded 0 (best) to 4 (worst). Each of those grades requires a percentage of involvement. Improvement is measured by reduction of involvement in any grade and any body area.|6 months|Only patients who were evaluable at 6mo are included.||participants|||Number
50919|NCT01309997|Secondary|Baseline Histopathologic Score in the Two Treatment Arms|"Instrument: Nash dermal fibrosis grade. Measures extent of sclerosis in skin biopsies by histologic examination. Scale ranges from grade 0-5. Nash grade 5 is most severe fibrosis (0 is better outcome, 5 is worse outcome). No subscales are used in Nash grade. Please see table 1 in the reference for grading of dermal fibrosis.~Nash RA, McSweeney PA, Crofford LJ, Abidi M, Chen CS, Godwin JD, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study. Blood 2007;110:1388-96."|Enrollment|Only patients with skin biopsies at enrollment are included.||units on a scale||Full Range|Median
50920|NCT01309997|Secondary|Number of Patients Achieving Improvement in Cutaneous Sclerosis|Assessed by decrease of >= 0.2 units (where 0 is best and 3.0 is worst ) in the Scleroderma Health Assessment Questionnaire (SHAQ).|6 months|Only patients evaluable at 6 mo are included.||participants|||Number
50921|NCT01309997|Secondary|Cumulative Incidence of Treatment Failure|Defined as discontinuation of randomized treatment due to chronic GVHD progression or treatment intolerance or no significant clinical response in sclerosis.|6 months|Only patients who were evaluable for SCR are included.||participants|||Number
50922|NCT01309997|Secondary|Patients Who Were Able to Taper Corticosteroids|Patients who achieved a greater than or equal to 50% reduction in the daily corticosteroid dose at 6mo compared to baseline|6 months|Patients with no corticosteroid dose data missing from baseline or 6mo.||participants|||Number
50923|NCT01309997|Primary|Significant Clinical Response|Assessed by decline in an affected area’s skin score as measured with the Vienna Skin Scale (from 4 [worst] to 2, 3 to 1, or 2 to 0 [best]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.|6 months|Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.||participants|||Number
50924|NCT01309919|Secondary|Insertion Time|Time of insertion of the IUD|immediate|||minutes||Standard Deviation|Mean
50925|NCT01309919|Secondary|Satisfaction|Participant satisfaction with the IUD at 12 weeks post-insertion|12 weeks post-partum|We assessed satisfaction with the IUD of all participants who completed the 12-week follow up call||% of participants who received an IUD|||Number
50926|NCT01309919|Secondary|Expulsions|Incidence of spontaneous IUD expulsion in the six months after insertion|6 months|We assessed the number of expelled IUDs for all participants who had an IUD placed||participants|||Number
50927|NCT01309919|Primary|Bleeding Patterns|Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum|12 weeks post-partum|We were able to analyze all returned bleeding diaries (25 participants in IUD Arm, 27 participants in Diary Arm)||days||Full Range|Median
50928|NCT01309893|Secondary|Overall Comfort|Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.|1 week|All eligible dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
50929|NCT01309893|Secondary|Slit Lamp Findings ≥ Grade 2|Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.|1 week|All dispensed eyes||eyes|Participants||Number
50930|NCT01309893|Primary|Distance High Contrast logMAR Visual Acuity at 1 Week|Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week|Baseline & 1 week|All eligible, dispensed eyes||logMAR|Participants|Standard Deviation|Least Squares Mean
50931|NCT01309880|Secondary|Comfort|At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.|1 Weeks|||units on a scale|Participants|Standard Deviation|Least Squares Mean
50932|NCT01309880|Secondary|Slit Lamp Findings|Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.|1 week|All Dispensed Eyes||eyes|Participants||Number
50933|NCT01309880|Primary|Visual Acuity|Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.|Dispensing & 1-week follow up|All Eligible, Dispensed Eyes||logMAR|Participants|Standard Deviation|Least Squares Mean
50944|NCT01309841|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of patients|||Number
52484|NCT01292135|Secondary|Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants|||Number
50934|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
50935|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.||units on a scale||Standard Error|Least Squares Mean
50936|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue – First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||hours||95% Confidence Interval|Median
50937|NCT01309841|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of SBMs/week||Standard Error|Least Squares Mean
50938|NCT01309841|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: “Did you feel like your bowels were completely empty after the bowel movement?” Patients provided a yes or a no response. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Percent days/week||Standard Error|Least Squares Mean
50939|NCT01309841|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
50940|NCT01309841|Secondary|Change From Baseline in Degree of Straining|A single-item straining question was asked via the eDiary: “How much did you strain during your bowel movement?” Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||units on a scale||Standard Error|Least Squares Mean
50941|NCT01309841|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Number of Days||Standard Error|Least Squares Mean
50942|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.||Hours||95% Confidence Interval|Median
50943|NCT01309841|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.||Number of patients|||Number
50945|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Both a Clinic Systolic and Diastolic Blood Pressure Response|Systolic/diastolic blood pressure is the arithmetic mean of the 3 serial sitting systolic/diastolic blood pressure measurements. Percentage of participants who achieved both a sitting clinic systolic and diastolic blood pressure response, defined as systolic blood pressure less than 130 mm Hg and diastolic blood pressure less than 80 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants||95% Confidence Interval|Number
50946|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Target Diastolic Blood Pressure <80 mm Hg|Diastolic blood pressure is the arithmetic mean of the 3 serial sitting diastolic blood pressure measurements. Percentage of participants at Week 52 who achieved a sitting clinic diastolic blood pressure response, defined as less than 80 mm Hg.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants||95% Confidence Interval|Number
50947|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieve Target Systolic Blood Pressure <130 mm Hg|Systolic blood pressure is the arithmetic mean of the 3 serial sitting systolic blood pressure measurements. Percentage of participants who achieve a sitting clinic systolic blood pressure response defined as less than 130 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.||percentage of participants||95% Confidence Interval|Number
50948|NCT01309828|Primary|Number of Participants With at Least 1 Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious AE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open- label study drug (up to 56 weeks).|Safety analysis set - All participants who received at least 1 dose of open-label study drug.||participants|||Number
50949|NCT01309737|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50950|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means ability to work was not affected by psoriasis, and 10 means ability to work was completely affected by psoriasis. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
50951|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable for specified timepoint for each arm, respectively.||percentage of scheduled hours||Standard Deviation|Mean
50959|NCT01309737|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of Participants|||Number
50952|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure for specified parameter for each arm, respectively.||hours||Standard Deviation|Mean
50953|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.||percentage of participants|||Number
50954|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants (currently employed [Emp]) answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants (unemployed [UEmp]) answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||participants|||Number
50955|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist and Rheumatologist. Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from a site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively.||events|||Number
50956|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline,Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||mm||Standard Deviation|Mean
50957|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50958|NCT01309737|Secondary|Joint Pain Assessment (JPA) Score|"The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain."|Baseline, Week 8,16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50960|NCT01309737|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of participants|||Number
50961|NCT01309737|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands Scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50962|NCT01309737|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale and 7 items comprising the depression subscale. Each item has response options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50963|NCT01309737|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50964|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."||units on a scale||Standard Error|Least Squares Mean
50965|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50966|NCT01309737|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."||units on a scale||Standard Error|Least Squares Mean
50967|NCT01309737|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
51419|NCT01303406|Primary|Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone|The primary efficacy endpoint was the comparison of the number of patients randomized to idebenone and placebo, who assessed that they received idebenone treatment.|At 2 months after study start|||participants|||Number
50968|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."||percentage of participants||95% Confidence Interval|Number
50969|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
50970|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'N' (number of participants analyzed) signifies participants with baseline nail psoriasis and who were unique in longitudinal model.|Baseline,Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."||percent change||Standard Error|Least Squares Mean
50971|NCT01309737|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. 'n' signifies participants evaluable at specified time point for each arm."||nails||Standard Deviation|Mean
50972|NCT01309737|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'n' signifies participants evaluable at specified time point for each arm.|Baseline,Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
50973|NCT01309737|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.'n' signifies participants evaluable at specified time point for each arm.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
51420|NCT01303380|Secondary|Number of Participants Exhibiting Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using bridging ECLIA assay.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.||Number of participants|||Number
50974|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked)."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of participants||95% Confidence Interval|Number
50975|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
50976|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
50977|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N'(number of participants analyzed) signifies the unique participants in the longitudinal model."||percent change||Standard Error|Least Squares Mean
50978|NCT01309737|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of BSA||Standard Deviation|Mean
50979|NCT01309737|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."||percent change||Standard Error|Least Squares Mean
51470|NCT01302899|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril||26 weeks|The safety analysis set consisted of all patients who received at least one study drug and had no major protocol deviations that could have impacted safety data.||Participants|||Number
50980|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50981|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 and where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50982|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. N (number of participants analyzed) signifies the unique participants in the longitudinal model."||units on a scale||Standard Error|Least Squares Mean
50983|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
50984|NCT01309737|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
50985|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."||percentage of participants|||Number
51036|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
50986|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."||percentage of participants||95% Confidence Interval|Number
50987|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
50988|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
50989|NCT01309737|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
50990|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
50997|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 4,16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
50991|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
50992|NCT01309737|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
50993|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included participants who were randomized to study, received at least 1 dose investigational drug. Participants from 1 site were excluded due to GCP compliance issues. 'N' (number of participants analyzed) were participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.||percent change||Standard Error|Least Squares Mean
50994|NCT01309737|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
50995|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline."|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
50996|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
50998|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
50999|NCT01309737|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
51000|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP non-compliance. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
51001|NCT01309737|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS): participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to good clinical practices(GCP) compliance issues. Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used.||percentage of participants|||Number
51002|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.||correlation coefficient|||Number
51003|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance|Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses in the immediate intervention group and one subject was missing responses in the wait list control group.||correlation coefficient|||Number
51004|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses from the wait list control group.||correlation coefficient|||Number
51005|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses from both the immediate intervention group and the wait list control group.||correlation coefficient|||Number
51006|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks|Correlation between baseline soluble transferrin receptor and the change in hemoglobin from the baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject in both the immediate intervention and the wait list control groups were missing responses.||correlation coefficient|||Number
51089|NCT01308918|Secondary|Correlation Between the Difficult Intubation Score and a Successful Intubation||1 hour (Post intubation)||||||
51090|NCT01308918|Secondary|Number of Attempt to Obtain a Successful Intubation||1 hour (Post intubation)|||Attempts|||Number
51007|NCT01309659|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Five subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.||participants|||Number
51008|NCT01309659|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Three subjects in both the immediate intervention group and the wait list control groups were missing responses.||participants|||Number
51009|NCT01309659|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Two subjects in the immediate intervention group and 5 subjects in the wait list group did not respond.||participants|||Number
51010|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as for each of the groups there was missing responses for subjects.||change in the total score||Standard Deviation|Mean
51011|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 2 subjects for each of the groups did not have a response for this data.||change in Z-score||Standard Deviation|Mean
51012|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Wait List Control did not respond to this during their clinic visit.||change in Z-score||Standard Deviation|Mean
51023|NCT01309646|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
51013|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.|Baseline, 12 Week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Immediate Intervention Group did not respond to this during their clinic visit.||change in Z-Score||Standard Deviation|Mean
51014|NCT01309659|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:~“In the past month, on average, have you been feeling unusually tired during the day?” is answered “yes” and indicated as “all of the time” or “most of the time.”~“In the past month, on average, have you felt unusually weak?” is answered “yes” and indicated as “all of the time” or “most of the time.”~Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.~The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at week 12 as reported by the subject."|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Results reported by number of participants reporting change from their baseline exhaustion, and low energy.||participants|||Number
51015|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.||correlation coefficient|||Number
51016|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to week 12. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Number of participants analyzed is correct- 2 subjects for Waitlist Group did not respond.||t score||Standard Deviation|Mean
51017|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. The number of participants analyzed is correct as 4 subjects for the wait list control group did not respond to this during their clinic visit.||change in seconds per completed circle||Standard Deviation|Mean
51018|NCT01309659|Secondary|Number of Participants Who Had a Hemoglobin Increase >= 1g/dL|To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12.|baseline, 12 weeks|||participants|||Number
51019|NCT01309659|Primary|Change in 6 Minute Walk Test Results|Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.||meters||Standard Deviation|Mean
51020|NCT01309646|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
51021|NCT01309646|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
51022|NCT01309646|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
51024|NCT01309646|Secondary|Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.|Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
51025|NCT01309646|Secondary|Concentrations of Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
51026|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
51027|NCT01309646|Secondary|Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||titers||95% Confidence Interval|Geometric Mean
51028|NCT01309646|Secondary|Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
51029|NCT01309646|Secondary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
51030|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
51031|NCT01309646|Secondary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
51032|NCT01309646|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).|A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
51033|NCT01309646|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
51034|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||Subjects|||Number
51035|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.||subjects|||Number
51037|NCT01309581|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)|The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).|Change from beginning of ECT treatment to end; on average 3 weeks||||||
51038|NCT01309581|Primary|Hamilton Rating Scale for Depression-24 (HRSD24)|"The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the gold standard clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability."|Change from beginning of ECT treatment to end; on average 3 weeks||||||
51039|NCT01309451|Primary|OCT CST|change in optical coherence tomography central subfield thickness|change in OCT CST from baseline to twelve months|||microns||Standard Deviation|Mean
51040|NCT01309451|Primary|Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline|Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 12 month|The unit of measure is EYES rather than actual number of participants||letters||Standard Deviation|Mean
51041|NCT01309386|Secondary|Average Change From Baseline in Amount of Rescue Medication Over Time|Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Milligram (mg)||Standard Deviation|Mean
51042|NCT01309386|Secondary|Number of Doses of Rescue Medication Over Time|Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Morphine-equivalent doses||Standard Deviation|Mean
51043|NCT01309386|Secondary|Total Number of Days of Rescue Medication Over Time|Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Days||Standard Deviation|Mean
51044|NCT01309386|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved."|Week 1, 4 and 8|Full analysis set (FAS) population; here ‘N’ signifies those participants evaluable for this outcome measure and ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Participants|||Number
51045|NCT01309386|Secondary|Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy|Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Participants|||Number
51046|NCT01309386|Secondary|Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8|Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Unit on scale||Standard Deviation|Mean
51047|NCT01309386|Primary|Percentage of Participants Who Achieved Pain Control|Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.|Week 1|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.||Percentage of Participants||95% Confidence Interval|Number
51048|NCT01309360|Secondary|Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.|In groups A, B and C was determined the rate of subjective clinical signs of increased Met-Hb-Levels : headaches or dizziness, when correlated with the peak-Met-Hb-Level.|Outpatients were followed for the duration of hospital stay, an average of six hours.|||participants|||Number
51049|NCT01309360|Primary|Onset Time.|Time from beginning of administration of the local anesthetic until complete sensoric block.|within 60 minutes after administration of the local anesthetic|In some cases the investigators were not able to exactly determine an onset time, so in cases of block failure (supplementation needed) or emergency situations outside this study (onset time not examined). Therefore the number of participants analyzed concerning onset time is lower then the total number of outpatients in each group.||minutes||Standard Deviation|Mean
51050|NCT01309360|Primary|Number of Participants With Complete Motor Blocks|To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic.|Within 60 minutes after administration of the local anesthetic|The analysis was per protocol.||participants|||Number
51051|NCT01309360|Secondary|Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability|In groups A, B and C was determined the rate of objective clinical signs of increased Met-Hb-levels : drops in oxygen saturation <93% using pulseoximetry or lip cyanosis.|Outpatients were followed for the duration of hospital stay, an average of six hours.|||participants|||Number
51052|NCT01309360|Secondary|Maximum Concentrations of Methemoglobin|Concentration of Methemoglobin (Met-Hb) was measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. The maximum amount was reached in every case two or three hours after administration of the local anesthetic.|0,1,2,3,4 hours post-dose|Methemoglobin (Met-Hb) levels were measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent.The mean maximum Met-Hb was estimated in each group.||percentage of methemoglobin||Standard Deviation|Mean
51053|NCT01309360|Primary|Number of Participants With Complete Sensory Block|The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.|60 minutes after administration of the local anesthetic|The analysis was per protocol.||participants|||Number
51054|NCT01309308|Secondary|The Duration of Latency Until Labor|The period (in days) from the last cervical measurement to the start of second phase of labor.|15 days|||days||Standard Deviation|Mean
51055|NCT01309308|Primary|Cervical Shortening|Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.|2days|analysis was per person who delivered||millimeters||Standard Deviation|Mean
51056|NCT01309282|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An Adverse Events (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Month 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.||Participants|||Number
51057|NCT01309282|Secondary|Number of Participants With Incidence of Infectious Events|Follow-up of the infectious events was done after Month 6 visit, Month 12 visit and Month 24 visit.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.||Participants|||Number
51058|NCT01309282|Secondary|Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions|An infusion reaction or injection site reaction is an event that occurs after infusion or injection which may include hypersensitivity reactions or anaphylactic reactions.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.||Participants|||Number
51059|NCT01309282|Secondary|Number of Participants on Each Pattern of Re-treatment|"There are two patterns of re-treatment, namely treat-to-target and according to the clinic.~Treat-to-target: a new cycle every 6 months if not in remission, with the participant receiving no new course of treatment as long as he is in remission.~On demand (according to clinic): a new cycle when, in an assessment performed at least 16 weeks after the last treatment cycle, the participant shows moderate or high disease activity [DAS28 > 3.2 or difference in DAS28 (ΔDAS28) > 0.6]"|Up to Month 24|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.||Participants|||Number
51060|NCT01309282|Secondary|Reason for Change From First TNF-inhibitor Therapy to Rituximab|Adverse event, primary and secondary insufficient responses and monoclonal gammopathy were the reasons for starting rituximab therapy.|At Screening|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.||Participants|||Number
51061|NCT01309282|Secondary|Mean Change Form Baseline in Functional Capacity at Month 24|The functional capacity was analyzed using Health Assessment Questionnaire-Disability Index (HAQ-DI). It is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 domains (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each domain are scored from 0 to 3 (0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do). Overall score was computed as sum of domain scores and divided by the number of domains. A total possible score ranged from 0 (best) to 3 (worst).|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, the results are presented only for the participants with available data and who completed Month 24 visit (n=7).||Scores on a scale||Standard Deviation|Mean
51062|NCT01309282|Secondary|Mean Change From Baseline in Severity of Pain at Month 24|The patient's assessment of pain was performed using a 100 mm VAS ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
51063|NCT01309282|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24|The Patient’s Global Assessment of disease activity was assessed using VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
51064|NCT01309282|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24|The Physician’s Global Assessment of disease activity was assessed using a Visual Analogue Scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
51065|NCT01309282|Secondary|Mean Change From Baseline in C-reactive Protein at Month 24|The C-reactive protein is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Milligrams/liter||Standard Deviation|Mean
51066|NCT01309282|Secondary|Mean Change From Baseline in ESR at Month 24|The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Millimeter (mm)/hour||Standard Deviation|Mean
51067|NCT01309282|Secondary|Mean Change From Baseline in SJC at Month 24|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Swollen joints||Standard Deviation|Mean
51068|NCT01309282|Secondary|Mean Change From Baseline in TJC at Month 24|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Tender joints||Standard Deviation|Mean
51069|NCT01309282|Primary|Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24|The disease-activity score 28 (DAS28) score is a measure of validated instrument for the assessment of the overall severity of RA disease activity calculated using the tender joint count (TJC), swollen joint count (SJC), patient's global assessment of disease activity, and erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).||Scores on a scale||Standard Deviation|Mean
51070|NCT01309269|Primary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during study period considered.||microgram (mcg)||Standard Deviation|Mean
51071|NCT01309269|Primary|Percentage of Participants Within Pre-defined Range of Hemoglobin Values|Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10–12 g/dL, 11-13 g/dL, and 10-13 g/dL.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.||percentage of participants|||Number
51072|NCT01309269|Primary|Hemoglobin Levels at Monthly Intervals|Hemoglobin levels were measured as grams/deciliter (g/dL).|Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.||g/dL||Standard Deviation|Mean
51652|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the procedure)|||kilogram force/second||Standard Deviation|Mean
51073|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance|Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Resistance Analysis Set||participants|||Number
51074|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, All Participants|Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Full Analysis Set||percentage of participants|||Number
51075|NCT01309243|Secondary|Change From Baseline in Fasting Triglycerides at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
51076|NCT01309243|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
51077|NCT01309243|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
51078|NCT01309243|Secondary|Change From Baseline in Fasting Total Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.||mg/dL||Standard Deviation|Mean
51079|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.||cells/μL||Standard Deviation|Mean
51080|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.||cells/μL||Standard Deviation|Mean
51081|NCT01309243|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.|Baseline to Week 96|Full Analysis Set||percentage of participants|||Number
51082|NCT01309243|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm.~The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time."|Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
51083|NCT01309204|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
51084|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)|The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|All eligible, dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
51085|NCT01309100|Primary|Visual Acuity (Investigational vs Acuvue Oasys Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.|1 week|All eligible, dispensed eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
51086|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)|The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|1-Week Follow-up, All Eligible, Dispensed Eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
51087|NCT01309100|Primary|Visual Acuity (Investigational vs Air Optix Aqua Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.|1 week|All eligible, dispensed eyes||LogMAR|Participants|Standard Deviation|Least Squares Mean
51088|NCT01308918|Secondary|Number of Complications Associated to the GlideRite DLT Stylet® Utilization|Complications defined either as oxygen desaturation below 95%, oxygen desaturation below 90%, minor bleeding, anatomic lesion.|1 hour (Post intubation)|||Participants|||Number
51091|NCT01308918|Secondary|Duration of the Intubating Process|The timer was started when the GLS blade was inserted between the lips and stopped when the proximal part of the tracheal cuff was passed through the vocal cords. When a patient had teeth at the superior jaw, the DLT was first inserted into the mouth prior to the insertion of the GLS blade in order to avoid rupturing the tracheal cuff. For these cases, the timer was started when the DLT was inserted between the lips.|1 hour (Post intubation)|||Seconds||Standard Deviation|Mean
51092|NCT01308918|Primary|Number of Successfull Primary Placement of the Double Lumen Tube.|To evaluate the number of participants where GlideRite DLT Stylet® associated to the video laryngoscopy (GlideScope®)allowed the primary placement of the double lumen tube into their trachea.|1 hour (Post intubation)|||Participants|||Number
51093|NCT01308840|Secondary|The Number of Participants Who Experience an Adverse Event|Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event|baseline to study completion|||participants|||Number
51094|NCT01308840|Secondary|Median Overall Survival|Death from any cause was used.|enrollment until date of death|||months||Full Range|Median
51095|NCT01308840|Secondary|Median Progression Free Survival|Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|time to cancer progression or death|||months||Full Range|Median
51096|NCT01308840|Primary|The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.|end of cycle 2 of treatment|||participants|||Number
51097|NCT01308788|Primary|2-year Change in OPP||Baseline and 24 month visits|||mm Hg||Standard Error|Mean
51098|NCT01308788|Primary|2-year Change in CRA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome||unitless||Standard Error|Mean
51099|NCT01308788|Primary|2-year Change in CRA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
51100|NCT01308788|Primary|2-year Change in CRA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
51101|NCT01308788|Primary|2-year Change in OA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome||unitless||Standard Error|Mean
51102|NCT01308788|Primary|2-year Change in OA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
51103|NCT01308788|Primary|2-year Change in OA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome||cm/sec||Standard Error|Mean
51104|NCT01308788|Primary|6-month Change in Ocular Perfusion Pressures (OPP)||Baseline and 6 month visits|||mm Hg||Standard Error|Mean
51105|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)||Baseline and 6 month visits|||unitless||Standard Error|Mean
51106|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
51107|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
51108|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)||Baseline and 6 month visits|||unitless||Standard Error|Mean
51109|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
51110|NCT01308788|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits|||cm/sec||Standard Error|Mean
51111|NCT01308762|Secondary|Administration Site Reactions|Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.|Day -3 to Day 56|Safety population||Participants|||Number
51112|NCT01308762|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"Safety and tolerability were measured with respect to:~Safety measurements~Local tolerability at the site of intradermal injection~Incidence of adverse events."|56 days|All analyses were based on the safety population, which comprised of all patients who received at least one dose of IMP. Safety measurements and nature and incidence of adverse events were reported for the Safety population||Participants|||Number
51113|NCT01308736|Primary|Cigarette Reduction|50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.|At 6-month follow-up|||participants|||Number
51114|NCT01308619|Secondary|Change From Baseline in Clinician's Erythema Assessment (CEA) Scores|Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst.|baseline to week 12|||units on a scale||Standard Deviation|Mean
51115|NCT01308619|Secondary|Investigator's Global Assessment (IGA) Scores at Week 12|Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|Week 12|||participants|||Number
51319|NCT01305473|Secondary|Complications in Subjects With Hernias Repaired With Sepramesh.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject’s medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.||participants|||Number
51116|NCT01308619|Secondary|Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12|Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 [LL-37] peptide.|baseline to week 12|Treatment success was defined as all subjects from either treatment group with a score of clear or near clear on the Investigator’s Global Assessment (IGA) scale. Treatment failure was defined as all subjects from either treatment group with a score of mild, moderate, or severe on the IGA scale.||micr grams protein||Standard Deviation|Mean
51117|NCT01308619|Primary|Change From Baseline in Inflammatory Lesion Counts|Mean change in inflammatory lesion counts from baseline to week 12|baseline to week 12|||inflammatory lesions||Standard Deviation|Mean
51118|NCT01308580|Secondary|Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel|Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points.||litre||Standard Deviation|Mean
51119|NCT01308580|Secondary|Plasma Clearance (CL) for Cabazitaxel|Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points.||Litre/hour||Standard Deviation|Mean
51120|NCT01308580|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs.|From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)|Safety population included all randomized participants who received at least one dose of the study drug during study treatment period.||percentage of participants|||Number
51121|NCT01308580|Secondary|Time to First Definitive Consumption of Narcotic Medication|Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
51122|NCT01308580|Secondary|Time to Definitive Weight Loss by 5% and 10% From Baseline|Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
51123|NCT01308580|Secondary|Time to Definitive Deterioration of ECOG PS Score From Baseline|The ECOG PS was used to evaluate participant’s DP and the effect of the disease on the participant’s activities of daily living. Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
51124|NCT01308580|Secondary|Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales|The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population.||months||95% Confidence Interval|Median
51125|NCT01308580|Secondary|Percentage of Participants With FACT-P Total Score Response|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure.||percentage of participants||95% Confidence Interval|Number
51134|NCT01308580|Secondary|Progression Free Survival (PFS)|PFS was evaluated from the date of randomization to the date of the first documentation of any of the following events: Radiological tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1); Prostate-Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.|From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
51126|NCT01308580|Secondary|Change From Baseline in FACT-P:Total Score as a Measure of HRQoL|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||95% Confidence Interval|Least Squares Mean
51127|NCT01308580|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|FACT-P population included randomized participants who completed FACT-P questionnaire at baseline & in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.||units on a scale||95% Confidence Interval|Least Squares Mean
51128|NCT01308580|Secondary|Percentage of Participants With Pain Response|Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value.||percentage of participants||95% Confidence Interval|Number
51129|NCT01308580|Secondary|Time to Pain Progression|Pain Progression was defined as an increase of ≥1 point in the median Present Pain Intensity (PPI) from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score (AS) compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
51130|NCT01308580|Secondary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value.||percentage of participants||95% Confidence Interval|Number
51131|NCT01308580|Secondary|Time to PSA Progression|Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of >25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
51132|NCT01308580|Secondary|Percentage of Participants With Overall Objective Tumor Response|Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value.||percentage of participants||95% Confidence Interval|Number
51133|NCT01308580|Secondary|Time to Tumor Progression|Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Analysis was performed by Kaplan-Meier method.|From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.||months||95% Confidence Interval|Median
51677|NCT01300767|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51135|NCT01308580|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.|From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants.||months||95% Confidence Interval|Median
51136|NCT01308476|Secondary|Patients Satisfaction With SMS System|Only patients in the SMS group were asked to assess their satisfaction with the SMS system by assigning German school grades 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=deficient, 6=insufficient.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percantage of participants|||Number
51137|NCT01308476|Secondary|Physicians Recommendation of the SMS System|Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know)|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percentage of participants|||Number
51138|NCT01308476|Secondary|Physicians Assessment of Usefulness of the SMS System|Only physicians of patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percentage of participants|||Number
51139|NCT01308476|Secondary|Patients Assessment of Usefulness of the SMS System|Only patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only||Percentage of participants|||Number
51140|NCT01308476|Secondary|Patients Compliance With SMS System|Compliance was defined as the percentage of patients answers to the IVR system as compared to the number of SMS automatically sent to the patients by the SMS/ IVR system asking for the number of Spiriva HandiHaler applications.|24 weeks|FAS||Percentage of participants answers||Standard Deviation|Mean
51141|NCT01308476|Secondary|Response Rate Regarding Adherence|Adherence was dichotomised into yes and no at the end of study depending on whether the percentage of adherence was at least 80 percent or less than 80 percent, respectively. Patients who did not respond to the SMS/ IVR system to provide information about the actual number of inhalations were considered with 0 percent adherence.|24 weeks|FAS||Percentage of participants|||Number
51142|NCT01308476|Secondary|Change From Baseline in Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Week 8, Week 12, Week 16, Week 20 and Week 24|FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis.||Percent change||Standard Deviation|Mean
51143|NCT01308476|Primary|Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24|"Full Analysis Set (FAS) is defined as all treated patients who additionally met the study diagnosis (Chronic Obstructive Pulmonary Disease (COPD) requiring long-acting anticholinergics) and who had evaluable data in at least one effectiveness endpoint.~Only subjects who responded to the SMS/ IVR system were considered in this analysis."||Percentage of applications||Standard Deviation|Mean
51144|NCT01308450|Primary|Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test.|"To increase the number of normal Adolescent and Adult tests to the existing Quotient System Database. To assure subjects are normal, participants will complete a standard battery of self assessment questionnaires to screen for the presence of mental health issues including: ADHD, Anxiety Disorder, Depressive Disorder or Bipolar Disorder using the following well established scales and their scoring guidelines:~ADHD Self Rating Scale (ASRS)~Zung Self-Rated Anxiety Scale (SAS)~Zung Self-Rated Depression Scale (SDS)~Mood Disorder Questionnaire (MDQ)~Quotient® ADHD System Test, Adolescent and version Each subject and their individual assessment scores will be evaluated by a physician. Those participants evaluated as normal(without ADHD) will have the results of their Quotient test added to the existing Quotient normative database of Non ADHD subjects."|12 to 18 weeks|||participants|||Number
51145|NCT01308424|Primary|Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).|Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.|7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)|As randomized subjects waited until reoccurrence of cold sore lesions, 23/87 participants in the placebo treatment group and 9/84 in the BTL-TML-HSV group took study medication and were eligible for the primary outcome.||percentage of Participants|||Number
51146|NCT01307787|Secondary|Change in Health Status: Social Interaction|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
51147|NCT01307787|Secondary|Change in Health Status: Psychological Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|analysis per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
51148|NCT01307787|Secondary|Change in Health Status: Physical Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
51149|NCT01307787|Secondary|Change in Muscle Strength of the Lower Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol,Lower extremity(LE) muscle strength data for one participant(n=1) in the WLC group is missing because knee problems prevented testing.||newton||Standard Deviation|Mean
51150|NCT01307787|Secondary|Change in Muscle Strength of the Upper Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol, one subject (n=1) in the intervention fitprogram withdrew from the study.||newton||Standard Deviation|Mean
51151|NCT01307787|Secondary|Change in Self-efficacy Function|Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from ‘totally disagree’ (1) to ‘totally agree’ (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|analysis per protocol, 2 subjects(n=2) in the intervention fitprogram withdrew from the study.||units on a scale||Standard Deviation|Mean
51152|NCT01307787|Secondary|Change in Self-efficacy Pain and Other Symptoms|Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from ‘totally disagree’ (1) to ‘totally agree’ (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|per protocol 2 subjects( n=2) in the intervention fitprogram withdrew from the study||units on a scale||Standard Deviation|Mean
51153|NCT01307787|Primary|Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness|maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants’weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from < 21( sedentary with disease) to > 57 ( very good physical condition).|baseline, postintervention at 9 weeks|Some VO2 max data (n=4 in the intervention group and n=2 in the WLC group)could not be collected because of specific participant conditions at different testing time points. 4 subjects did not reach the necessary heart rate to estimate the VO2 max. One subject had hypertension and one subject had knee problems.||ml/min/kg||Standard Deviation|Mean
51154|NCT01307618|Secondary|Gene Expression Profiles|Gene cluster analysis will be performed using deoxyribonucleic acid (DNA)-Chip Analyzer (dCHIP) software and comparisons will be made before and after treatment in each individual patient, and between responders and non-responders. Attempts will be made to identify gene expression profiles that correlate with clinical outcome.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and gene expression profiles was not measured.|||||
51155|NCT01307618|Secondary|Overall Survival Assessed by Modified WHO Criteria|Median overall survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.|Up to 4 years|||days||95% Confidence Interval|Median
51156|NCT01307618|Secondary|Progression-free Survival Assessed by Modified World Health Organization (WHO) Criteria|"Median progression-free survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.~The criteria for progressive disease are 1) appearance of new lesions, 2) 25% increase in the sum of the product of the largest perpendicular diameters of the indicator lesions, or 3) reappearance of any tumor."|Up to 4 years|||days||95% Confidence Interval|Median
51157|NCT01307618|Primary|Type and Grade of Toxicity Incidents Assessed by Common Toxicity Criteria Version 4.0 (CTCAE v4.0)||Up to 4 years|Patients who experienced any adverse event were counted.||participants|||Number
51168|NCT01307423|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52||06/2018||||
51158|NCT01307618|Primary|Absolute Number of CD4+CD25+FoxP3+ Regulatory T Cells From Peripheral Blood|Descriptive statistics and paired t-tests will be generated to describe the frequency and absolute number of CD4+CD25+FoxP3+ cells before and after daclizumab, and also at subsequent time points. Repeated measures of analysis of variance and mixed effects models will be used to further evaluate change in numbers over time, and to compare these changes between cohorts.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and absolute number of CD4+CD25+FoxP3+Regulatory T Cells from peripheral blood was not measured.|||||
51159|NCT01307618|Primary|Frequency of Vaccine-induced CD8+ T Cells Assessed by Enzyme-linked Immunospot (ELISPOT)|Data before treatment and after 3 vaccines will be assessed using paired t-tests within each cohort as well as a two-sample t-test of the mean post-treatment levels between cohorts. Repeated measures analysis of variance or mixed effects models will be utilized to further characterize changes in the levels of circulating T cells over time.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and frequency of vaccine-induced CD8+T cells was not measured.|||||
51160|NCT01307423|Secondary|Number of Participants With Adverse Events||Up to 5 years||06/2018||||
51161|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51162|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose MASES Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval was based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51163|NCT01307423|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 70% improvement in 78 tender joint count; ≥ 70% improvement in 76 swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51164|NCT01307423|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 50% improvement in 78 tender joint count; ≥ 50% improvement in 76 swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51165|NCT01307423|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject’s DAS28 as the measure of severity of disease. A Good response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method|Baseline and Week 52||06/2018||||
51166|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline by ≥ 1 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51167|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51678|NCT01300767|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51169|NCT01307423|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52||06/2018||||
51170|NCT01307423|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52||06/2018||||
51171|NCT01307423|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present|Baseline and Week 52||06/2018||||
51172|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52||06/2018||||
51173|NCT01307423|Secondary|Change From Baseline in the Participants Assessment of Pain Using the Visual Analog Scale at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52||06/2018||||
51174|NCT01307423|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Measure Description: Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51175|NCT01307423|Secondary|Change From Baseline in the SF-36v2 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52||06/2018||||
51176|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52||06/2018||||
51177|NCT01307423|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 20% improvement in 78 tender joint count; ≥ 20% improvement in 76 swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||06/2018||||
51192|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
51178|NCT01307423|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51179|NCT01307423|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment.~The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51180|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves to 0 at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51181|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose Maastricht Ankylosing Spondylitis Entheses Score Improves to 0 at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51182|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51183|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51184|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51185|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||Percentage of participants|||Number
51186|NCT01307423|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"The EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on th DAS-28.~Good or moderate response is defined as follows:~Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51187|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51188|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51189|NCT01307423|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject’s DAS28 as the measure of severity of disease. Good or moderate response is defined as follows:~Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51190|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51191|NCT01307423|Secondary|Percentage of Participants With ≥ 20% Improvement in Maastricht Ankylosing Spondylitis Entheses Score at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51679|NCT01300767|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51193|NCT01307423|Secondary|Change in Disease Activity Score (DAS 28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
51194|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16||units on a scale||Standard Error|Least Squares Mean
51195|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
51196|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
51197|NCT01307423|Secondary|Change From Baseline in Participants Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
51198|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16, or who did not have sufficient data for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51199|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
51214|NCT01307111|Primary|Patient Perceived Pain on a 100-point Visual Analogue Scale.|Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.|Prior to insertion, immediately after insertion, and prior to clinic discharge.|||units on a scale||Standard Deviation|Mean
51200|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
51201|NCT01307423|Secondary|Change in Baseline in the Disease Activity Score (DAS28) After 16 Weeks of Treatment|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
51202|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
51203|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline to Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
51204|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
51205|NCT01307423|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
51206|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51207|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
51215|NCT01307111|Secondary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.|Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).|Immediately post IUD insertion|||units on a scale||Standard Deviation|Mean
51208|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16||units on a scale||Standard Error|Least Squares Mean
51209|NCT01307423|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
51210|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
51211|NCT01307423|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; one participant randomized in error and not receiving any dose of investigational product was excluded. Participants who withdrew early or did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
51212|NCT01307319|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
51213|NCT01307319|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
51216|NCT01307046|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)||8 weeks|All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
51217|NCT01307046|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) Population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"||mmHg||95% Confidence Interval|Least Squares Mean
51218|NCT01307046|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"||mmHg||95% Confidence Interval|Least Squares Mean
51219|NCT01307033|Primary|Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)||Up to 52 weeks|All-Patients-as-Treated (APaT) Population, which consists of all randomized patients who received at least one dose of MK-0954A. The L100/H12.5 (L50/H12.5) arm only includes data from extension period (44 weeks); L100/H12.5→L100/H12.5 Open Label arm includes data from entire study period (52 weeks).||Percentage of Participants|||Number
51220|NCT01307033|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data||mmHg||95% Confidence Interval|Least Squares Mean
51221|NCT01307033|Secondary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data||mmHg||95% Confidence Interval|Least Squares Mean
51222|NCT01307020|Secondary|Percentage of Patients Using Rescue Medication at 6 Hours|Percentage of patients using rescue medication at 6 hours post-dosing.|Baseline to 6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment||percentage of patients|||Number
51223|NCT01307020|Secondary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %|4, 8 and 12 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment||percentage of patient|||Number
51224|NCT01307020|Primary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %|6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment||percentage of patients|||Number
51225|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.||units on a scale||Standard Deviation|Mean
51226|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.||units on a scale||Standard Deviation|Mean
51228|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis.||units on a scale||Standard Deviation|Mean
51229|NCT01306877|Secondary|Operative Room (OR) Time|Time of insertion of anoscope to time of anoscope removal after stapleline evaluation|Day 0|||minutes||Standard Deviation|Mean
51230|NCT01306877|Secondary|Length of Stay|Length of hospital stay is defined as time of anoscope insertion until discharge|Day 0 time of discharge minus time of admission|||Hours||Standard Deviation|Mean
51231|NCT01306877|Secondary|Location of the Staple Line|Distance of staple line to dentate line as measure by surgical ruler|Day 0|||mm||Standard Deviation|Mean
51232|NCT01306877|Secondary|Overall Quality of Life - General Health Score|Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health|Day 0 minus 60, 1 week, 1 month, 3 months, 6 months|||units on a scale||Standard Deviation|Mean
51233|NCT01306877|Secondary|Post-Operative Pain (Analgesic Intake)|post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.|Day 0, 1 week, 2 week, 1 month, 3 month, 6 month|||participants|||Number
51234|NCT01306877|Secondary|Post Operative Pain - (PI-NIRS)|"Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain.~The data represented is the change in baseline score at the different timepoints."|Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180|||units on a scale||Standard Deviation|Mean
51235|NCT01306877|Primary|Intraoperative Bleeding|Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.|Day 0 - time of surgery|||participants|||Number
51236|NCT01306643|Secondary|Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
51237|NCT01306643|Secondary|Changes in Concentration of Peripheral Blood Chemokines and Cytokines||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
51238|NCT01306643|Secondary|Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
51239|NCT01306643|Secondary|Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.|||||
51240|NCT01306643|Primary|Clinical Response: Overall Response Rate|"Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.~Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.~CR was defined as the disappearance of all evidence of disease.~PR was defined the regression of measurable disease and no new sites."|Up to twelve 28-day cycles (maximum of 12 months)|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
51241|NCT01306643|Primary|Overall Safety of Idelalisib|The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).|30 days post last study treatment (up to 12 months)|Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.||percentage of participants|||Number
51242|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
51243|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
51244|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
51245|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
51246|NCT01306617|Secondary|Resistance-Associated Variants and Phenotypic Resistance|Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at baseline and at the time of failure are presented.|Day 1 to post-treatment week 48|Resistance analyses included all participants who receive at least one dose of study drug (intent-to-treat [ITT] population).||participants|||Number
51247|NCT01306617|Secondary|Time to Virologic Relapse Post-treatment|Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to post-treatment week 48|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.||days||Standard Error|Mean
51248|NCT01306617|Secondary|Time to Failure to Suppress or Rebound During Treatment|Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||days||Standard Error|Mean
51249|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained virologic response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
51250|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained virologic response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
51251|NCT01306617|Secondary|Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
51252|NCT01306617|Secondary|Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
51253|NCT01306617|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
51254|NCT01306305|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population||Subjects|||Number
51255|NCT01306305|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP||Fold (ratio)|||Number
51256|NCT01306305|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP||Number of subjects|||Number
51257|NCT01306305|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population includes all subjects who received study vaccine||Subjects|||Number
51258|NCT01306305|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject lost to follow up and one subject who withdrew consent||Number of subjects|||Number
51259|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline|All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (Qp [litres per minute]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: [(mean PAP-PCWP) divided by Qp] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated.|Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).||dyne*sec/cm^5||Standard Deviation|Mean
51260|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).||mmHg||Standard Deviation|Mean
51261|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) >=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP <25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).||mmHg||Standard Deviation|Mean
51262|NCT01306253|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population||Subjects|||Number
51263|NCT01306253|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP||Fold (ratio)|||Number
51264|NCT01306253|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP||Number of subjects|||Number
51265|NCT01306253|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine||Subjects|||Number
51266|NCT01306253|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject per group lost to follow up||Number of subjects|||Number
51267|NCT01306214|Secondary|Change From Baseline in HbA1c After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)||percentage of HbA1c||Standard Error|Least Squares Mean
51268|NCT01306214|Secondary|Change From Baseline in Body Weight After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)||kg||Standard Error|Least Squares Mean
51269|NCT01306214|Secondary|Change From Baseline in Insulin Dose After 52 Weeks of Treatment|The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set-patients in FAS without important protocol violations leading to exclusion, completed minimum treatment of 357 days and did not prematurely discontinue. Values after start of antidiabetic rescue therapy (week 52 definition) were set to missing and last observation carried forward (LOCF-52) was used for imputation of missing values.||IU/day||Standard Error|Least Squares Mean
51270|NCT01306214|Primary|Change From Baseline in HbA1c After 18 Weeks of Treatment|The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.|Baseline and 18 weeks|The analysis was conducted on the full analysis set (FAS) of patients. Values after start of antidiabetic rescue therapy (week 18 definition) were set to missing and last observation carried forward (LOCF-18) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Least Squares Mean
51271|NCT01306201|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation.||Overall average|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
51272|NCT01306201|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.~The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average for 30 minutes|||Breaths Per Minute (BrPM)|||Number
51320|NCT01305473|Primary|Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.|A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.||participants|||Number
51273|NCT01306201|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.|Participants were monitored for average of 30 minutes|10 participants were excluded from data analysis due to following reasons: unreadable files,arrhythmia,electronic data files coud not be processed||BrPM (Breaths Per Minute)||Standard Deviation|Mean
51274|NCT01306175|Secondary|Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
51275|NCT01306175|Primary|Digoxin: Maximum Measured Concentration (Cmax)|Maximum measured concentration of digoxin, per period.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
51276|NCT01306175|Primary|Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.||ng-h/mL||Geometric Coefficient of Variation|Geometric Mean
51277|NCT01306162|Secondary|Free Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of free dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
51278|NCT01306162|Secondary|Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
51279|NCT01306162|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
51280|NCT01306162|Primary|Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|Pharmacokinetic (PK) set defined as all subjects randomised, treated and who provided evaluable data for at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
51281|NCT01306032|Primary|Progression Free Survival|Time to progression for each participant for the initial intervention.|Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.|Participants evaluable for response.||Cycles of therapy||Full Range|Median
51282|NCT01306032|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 30 days following the last dose of study drug.|||participants|||Number
51283|NCT01306032|Primary|Percentage of Participants With an Overall Response Rate|Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.|Participants evaluable for response.||percentage of participants|||Number
51284|NCT01305811|Other Pre-specified|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|2 months|||units on a scale||Standard Deviation|Mean
51285|NCT01305811|Primary|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|6 months|||units on a scale||95% Confidence Interval|Mean
51286|NCT01305772|Secondary|Nine (9) Month Overall Survival (OS)|Overall survival (OS) was defined as from the time of enrollment to the date of death resulting from any cause. Time as censored at the date of the last follow-up visit for subjects who were still alive. The 9-month OS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are alive.|9 months|||percentage of treated patients surviving||95% Confidence Interval|Number
51287|NCT01305772|Secondary|Nine (9) Month Progression Free Survival (PFS)|"Nine month progression-free survival (PFS) was defined from the time from enrollment to the first date of disease progression or death as a result of any cause. Progression was defined in the same manner as in RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5mm (the appearance of one or more new lesions is also considered progression).~Time was censored at the date of the last follow-up visit for subjects who were still alive and have not progressed. The 9 month PFS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are disease free or alive."|9 months|||percentage of treated patients||95% Confidence Interval|Number
51288|NCT01305772|Primary|Change in Tumor (Primary Tumor and Lymph Node) Response and Progression Between Pre- and Post- Panitumumab Therapy|"The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined in the same manner as in RECIST 1.1.~No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants."|Baseline to 2 years|No results will be reported for the primary outcome measure as only 2 of the 6 subjects had tissue collected after the first dose of panitumumab due to safety risk to the subject.|||||
51289|NCT01305655|Secondary|Evaluate Time at Hospital and Health Costs||6 years 6 months||01/2017||||
51290|NCT01305655|Primary|Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage.|"Glucarpidase was used in case of predefined toxic MTX values at defined time points and/or in combination with decreased renal function.~A total of 47 patients of the 1286 ALL-patients included in the protocol (3.7 %) were treated with Glucarpidase."|6 years 6 months|||participants|||Number
51291|NCT01305577|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
51292|NCT01305577|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
51293|NCT01305577|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:~How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are?” Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
51294|NCT01305577|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
51295|NCT01305577|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||percentage of participants|||Number
51296|NCT01305577|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||mm||Standard Deviation|Mean
51297|NCT01305577|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
51298|NCT01305577|Secondary|Change From Baseline in CR-SMFRS Scores|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
51299|NCT01305577|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.~The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
51416|NCT01303445|Primary|Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)|Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||(nanogram/milliliter)*hours||Geometric Coefficient of Variation|Geometric Mean
51300|NCT01305577|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
51301|NCT01305577|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population, which consisted of all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants|||Number
51302|NCT01305564|Secondary|Filter Penetration >3mm at Retrieval||Pre-retrieval|The denominator of 124 is equal to the number of subjects undergoing a retrieval procedure with imaging to confirm penetration.||percentage of participants||95% Confidence Interval|Number
51303|NCT01305564|Secondary|Filter Penetration >3mm at Placement||Post-placement|Penetration at Placement was measured immediately post-placement but prior to retrieval.||percentage of participants||95% Confidence Interval|Number
51304|NCT01305564|Secondary|Filter Tilt at Retrieval|Rate of filter indwell complications of: tilt >15°|Pre-retrieval imaging|All patients undergoing a retrieval procedure.||percentage of participants||95% Confidence Interval|Number
51305|NCT01305564|Secondary|Filter Tilt at Placement|Rate of filter indwell complications of: tilt >15°|Post-placement imaging|Tilt was measured post-placement with vena cavagram.||percentage of participants||95% Confidence Interval|Number
51306|NCT01305564|Secondary|Filter Migration|Rate of filter indwell complications of: migration >2cm.|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of migration.||percentage of participants||95% Confidence Interval|Number
51307|NCT01305564|Secondary|Filter Fracture|Rate of filter fracture|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of fracture.||percentage of participants||95% Confidence Interval|Number
51308|NCT01305564|Secondary|Rate of New or Worsening Deep Vein Thrombosis|Rate of new or worsening Deep Vein Thrombosis (DVT) from placement to the six month follow-up. Worsening DVT is defined as an extension of existing DVT to a new venous segment on ultrasound in patients that had DVT at the baseline visit.|6 months|The denominator of 188 is equal to the number of subjects completing the 6 month visit or with a filter retrieval procedure.||percentage of participants||95% Confidence Interval|Number
51309|NCT01305564|Secondary|Rate of Recurring Pulmonary Embolism|Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.|24 months|||percentage of participants||95% Confidence Interval|Number
51310|NCT01305564|Primary|Clinical Success of Retrieval|Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here.|24 months|||percentage of participants||95% Confidence Interval|Number
51311|NCT01305564|Primary|Technical Success of Retrieval|Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.|24 months|The denominator of 124 is equal to the number of subjects that had a filter retrieval procedure (successful and unsuccessful retrievals). Subjects were not required to have a retrieval procedure.||percentage of participants||95% Confidence Interval|Number
51312|NCT01305564|Primary|Clinical Success of Placement|Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.|6 months|The denominator of 189 is equal to all of the subjects that completed the 6 month visit, had their filter retrieved, or experienced a component of the clinical success of placement endpoint regardless of follow-up duration.||percentage of participants||95% Confidence Interval|Number
51313|NCT01305564|Primary|Technical Success of Placement|Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism.|6 months|||percentage of participants||95% Confidence Interval|Number
51314|NCT01305473|Post-Hoc|Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias|A recurrent hernia is a hernia (either umbilical or incisional), confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater|This analysis included the 5 subjects who underwent surgery to repair both incisional and umbilical hernias in the index procedure.||participants|||Number
51315|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh.|A recurrent umbilical hernia is an umbilical hernia, confirmed by the Investigator at any point after the surgery, in the same location as the umbilical hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 43 subjects who underwent surgery to repair umbilical hernias in the index procedure.||participants|||Number
51316|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh.|A recurrent incisional hernia is an incisional hernia, confirmed by the Investigator at any point after the surgery, in the same location as the incisional hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 42 subjects who underwent surgery to repair incisional hernias in the index procedure.||participants|||Number
51317|NCT01305473|Secondary|Recovery Time Associated With Hernias Repaired With Sepramesh.|Recovery time will be defined as the time it took for the subject to return to work.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|Data not available: none of the subject medical records reported return to work data. Secondary endpoint analysis could not be performed.|||||
51321|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51322|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51323|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51324|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51325|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51326|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51334|NCT01305408|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
51327|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51328|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51329|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51330|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51331|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51332|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
51333|NCT01305408|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
51371|NCT01304641|Primary|Number of Participants With Post-index Cardiovascular (CV) Events|CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Participants|||Number
51335|NCT01305408|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
51336|NCT01305408|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.||participants|||Number
51337|NCT01305408|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
51338|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
51339|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
51340|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
51341|NCT01305408|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
51372|NCT01304589|Secondary|24-hour Vulvar Pain|Measures average vulvar pain over 24-hours on daily diary|18 weeks|22 subjects were randomized to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes all 18 eligible subjects who completed all of the study visits.||units on a scale||Standard Deviation|Mean
51342|NCT01305408|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
51343|NCT01305408|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
51344|NCT01305265|Primary|Incidence of Tracheopharyngeal Symptoms||within 2 hours after extubation|||participants|||Number
51345|NCT01305239|Secondary|Event-free Survival|Event-free survival: time between first intake of exemestane and date of last follow-up or date of death for deceased participants (date of relapse or death or last follow-up minus first intake date) + 1 / 365.25 * 12.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|ITT population = all participants who received at least 1 dose of study drug and had at least 1 follow-up questionnaire completed. N = number of participants with analyzable (non-missing) data.||months||95% Confidence Interval|Mean
51346|NCT01305239|Secondary|Duration of Treatment|Total duration of adjuvant hormonal therapy with exemestane.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set; N = number of participants with analyzable (non-missing) data. For 2 participants lost to follow-up, the duration of exemestane was calculated until the date of lost to follow-up.||months||Standard Deviation|Mean
51347|NCT01305239|Secondary|Percentage of Participants Who Were Compliant With Treatment|Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. Information on compliance was not available for subjects who did not have a follow-up visit. N = number of participants with analyzable data.||percentage of participants||95% Confidence Interval|Number
51348|NCT01305239|Secondary|Reasons for Discontinuation of Aromasin Therapy||Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. N = number of participants with follow-up visit(s) who discontinued treatment with exemestane.||participants|||Number
51349|NCT01305239|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set: all participants who received at least 1 dose of study medication.||percentage of participants|||Number
51350|NCT01305044|Primary|Satisfaction With the Randomized Controlled Trial|The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.||units on a scale||Inter-Quartile Range|Median
51351|NCT01305044|Secondary|Inflammatory Cytokines|Fasting blood samples were collected in the morning for inflammatory cytokines. Prior to blood draws, we ensured that participants did not experience illness or fever at the time of the blood draw. The assayed cytokines included pro-inflammatory cytokines interleukin(IL)-12, IL-6, tumor necrosis factor (TNF)-α, and anti-inflammatory cytokines IL-10 and IL-4.|13-weeks|||pg/ml||Inter-Quartile Range|Median
51352|NCT01305044|Secondary|Cortisol Area-Under-Curve (AUC)|Five saliva samples (awakening, 30 minutes after awakening, noon, 5pm, & 10pm) were collected on a weekend day at one week after class completion. Cortisol was measured in nmol/L. Cortisol AUC was calculated using the five timepoints with the trapezoid rule. The groups were compared at post-intervention on their log transformed cortisol AUC controlling for baseline cortisol and reported as adjusted means. Four participants with high cortisol profiles across the five collection times (with suspected contamination from gum bleeding) and participants whose collection time was beyond a one hour window were excluded.|13-weeks|||nmol*hr/L||Standard Error|Mean
51353|NCT01305044|Secondary|Blood Pressure|Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.|13-weeks|Please refer to power calculation detailed in Primary Outcome Measure.||mm Hg||Standard Error|Mean
51354|NCT01305044|Secondary|Five-Facet Mindfulness Questionnaire|The Five-Facet Mindfulness questionnaire produces a total score and five facet subscales (observing, describing, acting with awareness, nonjudging, & nonreactivity). These are summation scores, and the scores range from 8 to 40 (except for the nonreactivity facet which ranges from 7 to 35). Higher scores indicate more mindfulness. The Total Score ranges from 39-195, with higher scores indicating more mindfulness.|13-weeks|||units on a scale||Inter-Quartile Range|Median
51355|NCT01305044|Secondary|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.|13-weeks|||units on a scale||Inter-Quartile Range|Median
51356|NCT01305044|Secondary|Impact of Events Scale|The Impact of Event Scale assesses cancer-specific distress. Each item is scored 0 (not at all), 1 (rarely), 3 (sometimes)or 5 (often), with the higher scores reflecting more stressful impact. It has a total score and two subscales (avoidance & intrusion). The two subscales are scored by summing their corresponding items and the total score is the sum of two subscales. The scores for the intrusive subscale range from 0 to 35, and scores for the avoidance subscale range from 0 to 40. The Total Score ranges from 0-75, with higher scores reflecting more stressful impact.|13-weeks|||units on a scale||Inter-Quartile Range|Median
51357|NCT01305044|Secondary|Perceived Stress Scale|The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.|13 weeks|||units on a scale||Inter-Quartile Range|Median
51358|NCT01305044|Secondary|Health-Related Quality of Life (Short Form (SF)-36v1)|SF-36v1 Health Survey assesses quality of life and produces mental and physical component summary scores, with a score range of 0 to 100. Higher scores indicate better quality of life.|13 weeks|Please refer to power calculation detailed in Primary Outcome Measure.||units on a scale||Standard Error|Mean
51359|NCT01305044|Primary|Retention Rates and Class Attendance|The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.||percentage of participants|||Number
51360|NCT01304966|Secondary|Cotreta-Derkay Score|"We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes~Coltera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.~Coltera-Derkay method of staging :~Clinical score:~Voice: Normal - 0, Abnormal - 1, Aphonia - 2~Stridor: Absent - 0, Present on activity - 1, Present at rest - 2~Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.~Anatomical score:~For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.~Total score = Anatomical score + Total clinical score"|12 months|||score||Standard Deviation|Mean
51361|NCT01304966|Primary|Human Papillomavirus Genotypes|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy|12 months|We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively.||participants|||Number
51362|NCT01304706|Primary|Number of Participants With Adverse Events|This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.|12 months|||participants|||Number
51363|NCT01304693|Secondary|Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria|Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.|Time to event, up to Month 6|ITT: All patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit.||Days||Inter-Quartile Range|Median
51364|NCT01304693|Primary|Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)|CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.|Baseline, Month 1|This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT). Efficacy data from visits occurring after standard of care (SoC) were censored and replaced based on LOCF,i.e. by the data observed at the time of the SoC decision.||microns||Standard Deviation|Mean
51365|NCT01304641|Secondary|Percentage of Participants Who Adhered to Index Therapy|Percentage of participants who adhered to index therapy was evaluated. Treatment adherence was defined as the number of days covered by index medication divided by the number of days in the post-index period, expressed as a percentage.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Percentage of participants|||Number
51366|NCT01304641|Secondary|Length of Post-index Period|Post-index period included time during which participants were observed for a minimum of 3 months following index date (fill date on which first observed atorvastatin or simvastatin was filled during the participant identification period) until disenrollment or end of study treatment (28 February 2009).|Index date (baseline) up to end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Days||Standard Deviation|Mean
51367|NCT01304641|Secondary|Number of Participants Per Dose|Index dose was categorized as low dose (atorvastatin 10 mg, simvastatin up to 20 mg), medium dose (atorvastatin 20 mg, simvastatin 40 mg), and high dose (atorvastatin 40 or 80 mg, simvastatin 80 mg).|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Participants|||Number
51368|NCT01304641|Secondary|Mean Dose|The first observed study medication fill during the participation identification period was defined as the index drug. The initial dose of the index drug was determined based on the pharmacy claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||mg||Standard Deviation|Mean
51369|NCT01304641|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)||At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
51370|NCT01304641|Primary|Hazard Ratio for First Cardiovascular (CV) Event|Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.||Participants|||Number
51375|NCT01304589|Primary|Pain Rating Index|"The primary outcome measure will be pain ratings on the Pain Rating Index (PRI) of the short-form McGill Pain Questionnaire (SF-MPQ), which consists of 15 representative words from the sensory (n = 11) and affective (N = 4) categories of the standard, long-form (LF-MPQ). On the PRI, each descriptor is ranked by the patient on an intensity scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. Total score - 0 equals no pain to 45 equals severe pain. The paired t-test was used to compare the PRI score at baseline and at 18 weeks or to further clarify, pre-treatment versus post-treatment comparison."|18 weeks|22 subjects were eligible and received study medication. Analysis population included all 22 eligible subjects.||units on a scale||Standard Deviation|Mean
51376|NCT01304329|Secondary|Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
51377|NCT01304329|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
51378|NCT01304329|Primary|Simvastatin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
51379|NCT01304329|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values"|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
51380|NCT01304329|Primary|Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin.~The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
51381|NCT01304329|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
51382|NCT01304277|Secondary|Overall Summary of TEAEs by Treatment (Replagal RB and Replagal AF)|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status, concomitant medication, vital signs and ECG.|Week 2 to EOS|||participants|||Number
51383|NCT01304277|Secondary|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status (in Serum) at End of Study||EOS|||participants|||Number
51384|NCT01304277|Secondary|Dose-normalized Maximum Serum Concentration (Cmax/Dose)||Week 0 to Week 14|||Ratio||90% Confidence Interval|Geometric Mean
51385|NCT01304277|Secondary|Dose-normalized AUC Extrapolated to Infinity (AUC∞/Dose)||Week 0 to Week 14|||Ratio||90% Confidence Interval|Geometric Mean
51386|NCT01304277|Secondary|Dose-normalized Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast/Dose)||Week 0 to Week 14|||Ratio||90% Confidence Interval|Geometric Mean
51387|NCT01304277|Secondary|Change From Baseline to Week 16 (EOS) in Plasma Gb3 Levels||Baseline to EOS|||(nmol/mL)||Standard Deviation|Mean
51388|NCT01304277|Primary|Change From Baseline to Week 16 (EOS) in Urine Gb3 Levels||Baseline to EOS|||(nmol/g creatinine)||Standard Deviation|Mean
51389|NCT01304238|Secondary|Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
51680|NCT01300767|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51390|NCT01304238|Secondary|Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
51391|NCT01304238|Secondary|Number of Participants Who Underwent Amputation After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
51392|NCT01304238|Secondary|Number of Participants With Fatal Complications After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
51393|NCT01304238|Secondary|Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
51394|NCT01304238|Primary|Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II|Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.||participants|||Number
51395|NCT01304147|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.|2 weeks|Number of events, more detailed in adverse event section||events|||Number
51396|NCT01304147|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration~10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points."|24 hours|20 patients randomized and 18 completed both treatment periods||participants|||Number
51397|NCT01303861|Secondary|Continuous Cigarette Abstinence From Quit Date|Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).|From Quit date to end of treatment (week 11)|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.||participants||95% Confidence Interval|Number
51398|NCT01303861|Secondary|Seven Day Point Abstinence From Cigarette Smoking|Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.|Six months post quit date|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.||participants||95% Confidence Interval|Number
51399|NCT01303861|Primary|Four-week Continuous Abstinence From Cigarette Smoking|The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.|Study week 8 thru week 11|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.||percentage of participants||95% Confidence Interval|Number
51400|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline|Patients completed neurocognitive testing at each QoL measurement assessment. Neurocognitive function was measured via a computerized neurocognitive test battery called CNS Vital Signs. The battery consists of 7 tests that assess verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention, and continuous performance. The battery provides scores over 9 domains with higher scores indicating better performance. Scores were normalized to a standard score mean of 100 and standard deviation of 15 using a normative sample. The mean difference in score in each domain between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in mean score, while a difference less than 0 indicates a decrease in mean score.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial CNS Vital Signs assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.||Scores on a Scale||Standard Deviation|Mean
51417|NCT01303445|Primary|Plasma Dipyridamole Maximum Concentration (Cmax)|Maximum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
51401|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline|Patients completed the 6-minute walk test (6MWT) at each QoL measurement assessment. The 6 minute walk test is a measure of functional capacity in which the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes is measured. The mean difference in distance traveled (in meters) between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in distance traveled, while a difference less than 0 indicates a decrease.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial 6MWT assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.||Meters||Standard Deviation|Mean
51402|NCT01303835|Primary|Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline|"The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated.~Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132)~Functional Assessment of Chronic Illness Therapy (FACIT-F) measures level of fatigue during patients’ usual daily activities (range 0-52)~Epworth Sleepiness Scale measures level of daytime sleepiness. Note that higher scores indicate a greater level of sleepiness (range 0-24)~Medical Outcomes Survey (MOS) measures QoL including physical, mental and general health via 8 domains (range 0-100 for each domain)~Zung Self-Rating Depression Scale quantifies the depressed status of a patient. Lower scores indicate more favorable outcome (range 20-80) A difference"|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial QOL assessments and the 16 week QoL assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.||Scores on a Scale||Standard Deviation|Mean
51403|NCT01303744|Secondary|Changes in Plasma ΔTNFα Concentrations||29 days|ITT||pg/ml||Standard Error|Mean
51404|NCT01303744|Secondary|Measurement of Trough CHF 5074 Plasma Levels|evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.|Days 85|||ng/ml||Standard Deviation|Mean
51405|NCT01303744|Primary|Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point|To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo|up to 12 weeks|ITT||pg/ml||Standard Error|Mean
51406|NCT01303627|Primary|Smooth cLMA Removal Condition (Score 1)|cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)|At the end of the surgery|||percentage of participants|||Number
51407|NCT01303510|Secondary|Incidence of Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population||Subjects|||Number
51408|NCT01303510|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP||Fold (ratio)|||Number
51409|NCT01303510|Primary|Seroprotection|Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP||Subjects|||Number
51410|NCT01303510|Primary|Seroconversion|Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations exclude one subject lost to follow up||Subjects|||Number
51411|NCT01303510|Secondary|Safety: Incidence of Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine||Subjects|||Number
51412|NCT01303445|Secondary|Percentage Peak-to-trough Fluctuation (%PTF)|PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||percent of average hourly plasma conc.||Standard Deviation|Mean
51413|NCT01303445|Secondary|Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)|IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.||percent of baseline platelet aggregation||Standard Deviation|Mean
51414|NCT01303445|Secondary|Plasma Dipyridamole Minimum Concentration (Cmin)|Minimum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
51415|NCT01303445|Primary|Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)|IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.||percent of baseline platelet aggregation||Standard Deviation|Mean
51418|NCT01303406|Secondary|Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms|There was no Withdrawal due to recurrence or worsening of FRDA symptoms|Within 2 months (i.e. Early withdrawal visit)|||percentage of patients|||Number
51421|NCT01303380|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of sandwich ELISA assay with limit of detection at 0.1 picogram/millilitre.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.||picogram(s)/milliliter||Standard Deviation|Mean
51422|NCT01303380|Secondary|Serum Concentration-time Profile of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics (PK) of the drug.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.||microgram(s)/milliliter||Standard Deviation|Mean
51423|NCT01303380|Secondary|Participants Who Received Rescue Treatment|Participants who experienced flares were treated with corticosteroids and NSAIDs as rescue medication.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.||Percentage of participants|||Number
51424|NCT01303380|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (Start of study treatment) up to Month 36 (End of study)|The analysis was performed on Safety Set (SAF) population defined as all participants who received at least one application of study treatment and had at least one post-baseline safety assessment.||Number of participants|||Number
51425|NCT01303380|Secondary|Time to Flare After the Last Dose of Canakinumab During the Follow-up Period|The median time to flare by the participants after administration of the last dose of canakinumab during the follow-up period was analysed using Kaplan-Meier method.|Last dose of canakinumab treatment in follow-up period to end of follow-up period (Day 337)|"The analysis was performed on the FAS population. Here Number of participants analysed signifies the participants assessed for time to flare after the last dose of canakinumab during follow-up period."||days||Full Range|Median
51426|NCT01303380|Secondary|Duration of Flares Experienced During the Study|Flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L. The change in post canakinumab treatment flare duration during the study were assessed as compared to historical period.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.||Days||Full Range|Median
51427|NCT01303380|Secondary|Percentage of Participants Who Received Dose Up-titration During 6-month Treatment Period|Participants who experienced a new HIDS flare between baseline and Week 4 and received an escalated dose of 450 mg of canakinumab every 6 weeks thereafter starting at Week 6 were determined.|Day 1 up to Month 6 (End of follow up)|The analysis was performed in the FAS population.||Percentage of participants|||Number
51428|NCT01303380|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Global Score in Children Over Time|Participants or their parents (participants aged 6 to 17 years) were assessed for HRQoL based on Childhood Health Assessment Questionnaire (CHAQ). CHAQ was an eight domain questionnaire representing functional capacity and independence, evaluated for previous week. Each domain was rated on a 4-point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do.The total score is the mean from the 8 scores, and ranges from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for CHAQ during study."||Score on a scale||Full Range|Median
51429|NCT01303380|Secondary|Health Assessment Questionnaire (HAQ) Global Score in Adults Over Time|Participants were assessed for health-related quality of life (HRQoL) based on Health Assessment Questionnaire (HAQ). HAQ was an eight 8 categories questionnaire representing all activities related to physical function. Each category has various sub-categories, which were rated by the participants on a 4- point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The total score was the mean of the 8 scores, and ranged from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for HAQ during study."||Score on a scale||Full Range|Median
51430|NCT01303380|Secondary|Change From Baseline in Inflammation Markers Over Time up to Month 24|The C-reactive Protein (CRP) and/or Serum amyloid A protein (SAA) were used as inflammatory markers. The normal range of CRP was 0-10 mg/L.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.||milligram(s)/liter||Full Range|Median
51431|NCT01303380|Secondary|Time to Resolution of the Initial Flare After First Canakinumab Treatment|Time to resolution of the initial flare after first dose of canakinumab was determined.|Day 1 (Baseline), Day 28|The analysis was performed in the FAS population.||Days||Full Range|Median
51471|NCT01302899|Secondary|Plasma Rennin Concentration (PRC)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51432|NCT01303380|Secondary|Percentage of Participants Experiencing Abdominal Pain as Assessed by Physician's Global Assessment|Abdominal pain was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
51433|NCT01303380|Secondary|Percentage of Participants Experiencing Lymphadenopathy as Assessed by Physician's Global Assessment|Lymphadenopathy severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
51434|NCT01303380|Secondary|Percentage of Participants Experiencing Apthus Ulcers as Assessed by Physician's Global Assessment|Apthus ulcers were assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
51435|NCT01303380|Secondary|Percentage of Participants Experiencing Fever as Assessed by Physician's Global Assessment|Fever severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
51436|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Physician Assessed Symptom Control|Participants were assessed by physician for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
51437|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Participants Assessed Symptom Control|Participants were assessed by participants/parent (participants aged 6-18 years) for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Percentage of participants|||Number
51438|NCT01303380|Secondary|Number of Participants With Flare Events Based on Participant Assessed HIDS Flare Severity Score|Participant's global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5-point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe. Same investigator assessed the same participant throughout the study to ensure consistency between assessments. Investigators reviewed every participant's diary at each visit after their own clinical assessment.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.||Number of participants|||Number
51439|NCT01303380|Secondary|Number of Participants With Flare Events Based on Physician Assessed HIDS Flare Severity Score|Physician global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5­ point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe.|Any flare event [Baseline up to Month 36 (End of long term treatment period 2)]|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Number of participants|||Number
51440|NCT01303380|Secondary|Number of Participants Who Flared at Month 6, Month 24 and Month 36|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Baseline, Month 6 (End of treatment period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.||Number of participants|||Number
51441|NCT01303380|Secondary|Number of Flares Per Participant at During Treatment Period and 24 Month Extension Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Month 6 (End of treatment period), Month 36 (End of Long term treatment Period 2)|The analysis was performed in the FAS population.||Number of flares||Full Range|Median
51442|NCT01303380|Primary|Number of Flares Per Participant During Historical Period and Treatment Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a C­reactive protein (CRP) value > 10 mg/L. Flares during a historical period were defined as most recent 6-months in which the participant has not received treatment for their HIDS other than symptomatic treatment with NSAIDs and/or corticosteroids.|Historical period, Month 6 (End of treatment period)|The primary analysis was performed in the Full Analysis set (FAS) population defined as all participants who received at least one dose of study treatment and had at least one post baseline assessment.||Number of flares||Full Range|Median
51472|NCT01302899|Secondary|Plasma Rennin Activity (PRA)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51443|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the male population (226)||participants|||Number
51444|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the female population (333)||participants|||Number
51445|NCT01303224|Secondary|Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)|Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from “0”= worst imaginable health state to “100”=best imaginable health state.|Eight weeks|Intention-to-treat; i.e. all ITT patients who provided EQ-5D data at Visit 2 (start of treatment) and Visit 4 (end of treatment).||units on a scale||Standard Deviation|Mean
51446|NCT01303224|Secondary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule)"|Eight weeks|Intention-to-Treat (559)||participants|||Number
51447|NCT01303224|Primary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).|"Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat (559)||participants|||Number
51448|NCT01302938|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (<) 0.8 lower limit of normal(LLN); platelet <0.5 LLN, >1.75 upper LN (ULN);white blood cell <0.6 LLN, >1.5 ULN; lymphocyte, total neutrophil(absolute[AL]),Total protein, albumin, phosphate <0.8 LLN, >1.2 ULN; basophil, eosinophil, monocyte >1.2ULN; Total bilirubin >1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase >3ULN; Blood urea nitrogen, creatinine >1.3ULN; sodium <0.95LLN, >1.05ULN; potassium, chloride, bicarbonate, calcium <0.9LLN, >1.1ULN.|Week 12|Safety set included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
51449|NCT01302938|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.||participants|||Number
51450|NCT01302938|Other Pre-specified|Number of Participants With Adverse Events (AEs) by Relatedness and Severity|AE:any untoward medical occurrence attributed to study medication in participant who received study drug. Relatedness to study medication was assessed by the investigator. Severity of AEs assessed as: mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Mild, moderate and severe are not mutually exclusive; hence same participant may be included in more than 1 type of severity of AEs.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.||participants|||Number
51451|NCT01302938|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.||participants|||Number
51452|NCT01302938|Secondary|Participant Perception Regarding Recommending a Friend to Enter Similar Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 6, “How likely would you be to recommend a friend to enter a similar study?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
51453|NCT01302938|Secondary|Participant Perception Regarding Received Treatment in the Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 5, “What treatment did you think you were on?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
51454|NCT01302938|Secondary|Participant Perception Regarding Cell Phone Diary|PEQ:self-administered, assesses participants perception of trial method. Question4, “How satisfied were you with items?” on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
51455|NCT01302938|Secondary|Participant Perception Regarding Satisfaction Related to Study|PEQ:self-administered, to assess perception of trial method. Question3, “How satisfied were you with items?” on scale 1(very satisfied) to 5(very dissatisfied)- recruitment; questionnaires,surveys(Ques,Sur); identification verification(IV); informed consent(IC) process; website experience; phone call; laboratory(lab) kit delivery; lab location; lab staff service(Ser); physical exam(PE) scheduling,location (sch,loc); PE visit; medication(med) first batch delivery; med second batch delivery; cell phone(CP) received; CP use; call center(CC) ser; medical support(supp); technical supp; overall.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
51456|NCT01302938|Secondary|Number of Participants With Reason for Participation in the Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 2, “What led you to participate given the study drug is already available?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
51457|NCT01302938|Secondary|Number of Participants With Response Regarding Source of First Information About Study|Participant experience questionnaire (PEQ) is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 1, “Where did you hear first about the study?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
51458|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Full Range|Median
51459|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
51460|NCT01302938|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
51461|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12|PPUS: a self-administered, single-item, validated questionnaire that measures the participant’s perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet [without leaking]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC).|Baseline (Bl), Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||participants|||Number
51473|NCT01302899|Secondary|Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51474|NCT01302899|Secondary|Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51475|NCT01302899|Secondary|Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51462|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12|PPBC: self-administered,single-item questionnaire to describe participant’s perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC).|Baseline, Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||participants|||Number
51463|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||episodes per 24 hours||Standard Deviation|Mean
51464|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related nocturnal urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 that occurred between time participant went to bed and time participant arose to start next day divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.|||||
51465|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.|||||
51466|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||micturitions per 24 hours||Standard Deviation|Mean
51467|NCT01302938|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||episodes per 24 hours||Full Range|Median
51468|NCT01302938|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||milliliter (mL)||Standard Deviation|Mean
51469|NCT01302938|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using Last observation carried forward (LOCF) method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||micturitions per 24 hours||Standard Deviation|Mean
51589|NCT01301963|Secondary|Compare Need for Hospitalization During Mobilization Between Mobilization Groups||Day 1||||||
51590|NCT01301963|Secondary|Compare Days of Apheresis Between Mobilization Groups|Using the Wilcoxon Rand Sum Test|Day 1||||||
51476|NCT01302899|Secondary|Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function|All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51477|NCT01302899|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51478|NCT01302899|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51479|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51480|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis|||||
51481|NCT01302860|Secondary|Number of Participants With Anti-canakinumab Antibodies at Week 56|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|Week 56 (End of study)|The analysis was performed in the safety set population. Here, ‘Number of participants analysed’ signifies participants who had immunogenicity samples taken and analyzed during the study.||participants|||Number
51482|NCT01302860|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|Day -14 (prior-vaccination), Day 0 (vaccination), Day 28, Day 57 (post-vaccination)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies evaluable participants who received a total of 31 vaccinations during the study."||vaccination cases|||Number
51483|NCT01302860|Secondary|Percentage of Participants Receiving a Concomitant Vaccination During the Study|Participants received any one of the following inactivated vaccines as per the immunization program: Corynebacterium diphtheria, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani, Influenza type A, Influenza type B, Haemophilus influenza B, Streptococcus pneumoniae, or Hepatitis B were determined.|Day 1 (start of study treatment) to Week 56 (end of study)|The analysis was performed in the FAS population.||Percentage of participants|||Number
51484|NCT01302860|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (start of study treatment) up to Week 56 (end of study)|The analysis was performed in the safety set population defined as participants who received at least one dose of study drug. Here, ‘n’ signifies participants evaluable for this measure at specified time points for each group, respectively.||participants|||Number
51485|NCT01302860|Secondary|Change From Baseline in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations at Week 56|The CRP and SAA were used as inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Baseline, Week 56|The analysis was performed in FAS population. Here ‘n’ signifies those participants with evaluable measurements at both baseline and the post-baseline visit.||mg/L||Standard Deviation|Mean
51486|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician Assessment of Skin Disease at Week 56|Participants were assessed by physician for skin disease (urticarial skin rash) measured on a 5-­point scale as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.||Percentage of participants|||Number
51487|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician’s Global Assessment Score at Week 56|Participants were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.||Percentage of participants|||Number
51681|NCT01300767|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51488|NCT01302860|Secondary|Percentage of Participants Aged 2 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as CRP or SAA to be <15 mg/L and <10 mg/L respectively.|Week 56|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants aged 2 years or younger."||Percentage of participants|||Number
51489|NCT01302860|Primary|Percentage of Participants Aged 4 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as C reactive protein (CRP) or Serum amyloid A protein (SAA) to be less than (<) 15 milligram per liter (mg/L) and <10 mg/L respectively.|Week 56|The analysis was performed in Full analysis set (FAS), defined as all participants who received at least one dose of study drug under this study protocol.||Percentage of participants|||Number
51490|NCT01302691|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
51491|NCT01302691|Primary|Percentage of Participants Who Had Study Drug Stopped Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm|up to 8 weeks|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
51492|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related SAE|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
51493|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
51494|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
51495|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
51496|NCT01302691|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
51497|NCT01302548|Secondary|Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.|"The Abscess Measurement Scale was measured using a centimeter ruler.~Scale 8cm – 10cm = Severe 6cm – 8cm = Moderate/severe 4cm – 6cm = Moderate 2cm – 4cm = Mild/moderate 0cm – 2cm = Mild"|48 hours|Only participants that were MRSA-positive, were analyzed.||units on a scale||Standard Deviation|Mean
51498|NCT01302548|Secondary|Number of Patients Prescribed Oral Antibiotics|Number of patients prescribed oral antibiotics|48 hours|||participants|||Number
51499|NCT01302548|Primary|Abscess Healing Based on Abscess Measurement Scale|"The abscess healing process will use two methods: 1) usual method includes saline irrigation and/or incision & drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler.~Scale 8cm – 10cm = Severe 6cm – 8cm = Moderate/severe 4cm – 6cm = Moderate 2cm – 4cm = Mild/moderate 0cm – 2cm = Mild"|48 hours|||units on a scale||Standard Deviation|Mean
51500|NCT01302483|Secondary|Maximum Change in Pulse Oximetry From Baseline|Maximum change from Baseline at any time point|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intent to Treat||SpO2||Standard Deviation|Mean
51501|NCT01302483|Secondary|Maximum Change in Blood Pressure From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40 50, 60, 120 minutes|Intention to treat||mmHG||Standard Deviation|Mean
51502|NCT01302483|Secondary|Maximum Change in Pulse From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intention to treat||beats per minute||Standard Deviation|Mean
51503|NCT01302483|Secondary|Soft Tissue Anesthesia Duration|"Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were:~Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule~Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule~Site 3: Incisive papilla~Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)"|Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes|Intention to treat||Minutes||Standard Deviation|Mean
51504|NCT01302483|Primary|Pulpal Anesthesia|Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.|Continuous throughout dental treatment period (up to 60 minutes)|Intention to treat||participants|||Number
51505|NCT01302444|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP)as Assessed by Transthoracic Echocardiography Using Doppler Ultrasound||16 weeks|data not reported for one participant for anonymity|||||
51506|NCT01302444|Secondary|Plasma BNP (Brain Natriuretic Peptide)Level Change||16 weeks of therapy|data not reported for one participant for anonymity|||||
51507|NCT01302444|Secondary|Tei Index Change by Transthoracic Echocardiography||16 weeks of therapy|data not reported for one participant for anonymity|||||
51508|NCT01302444|Secondary|6 Minute Walking Distance Change Will Improve||16 weeks of therapy|data not reported for one participant for anonymity|||||
51509|NCT01302444|Primary|Hospitalizations||16 weeks|data not reported for one participant for anonymity|||||
51510|NCT01302444|Primary|WHO Functional Class Will Improve or Remain Stable||16 weeks|data not reported for one participant for anonymity|||||
51511|NCT01302444|Primary|Adverse Events Are no Greater Than With Treprostinil Infusion Alone||16 weeks|data not reported for one participant for anonymity|||||
51512|NCT01302444|Primary|All Cause Mortality||16 weeks|data not reported for one participant for anonymity|||||
51513|NCT01302418|Primary|Detection of Respiratory Viruses|The presence of Influenza A or Influenza B virus.|Specimens will be taken within 5 days of the appearance of symptoms.|All subjects meeting inclusion/ exclusion criteria and who had sufficient specimen volume.||participants|||Number
51514|NCT01302392|Secondary|Duration of Disease Control|Duration of Disease Control was calculated for subjects who achieved disease control. Duration of Disease Control was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving disease control through the final analysis data cutoff with longest follow-up time of approximately 31 months.|The intent to treat (ITT) population comprised randomized participants who achieved disease control.||months||95% Confidence Interval|Median
51515|NCT01302392|Secondary|Disease Control|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||participants|||Number
51516|NCT01302392|Secondary|Duration of Clinical Benefit|Duration of Clinical Benefit was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) or minimal response (MR). Duration of Clinical Benefit was defined as the time in months from the initial start of response (MR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving clinical benefit through the final analysis data cutoff with longest follow-up time of approximately 30 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of MR or better only.||months||95% Confidence Interval|Median
51517|NCT01302392|Secondary|Clinical Benefit Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||participants|||Number
51607|NCT01301729|Secondary|Time to Progression|Time to progression was defined as the time from the date of enrollment until the date of progressive disease.|From the date of enrollment until the date of progressive disease (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||months||95% Confidence Interval|Median
51518|NCT01302392|Secondary|Duration of Response|Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From the time achieving response through the final analysis data cutoff with longest follow-up time of approximately 29 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of PR or better only.||months||95% Confidence Interval|Median
51519|NCT01302392|Secondary|Overall Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||participants|||Number
51520|NCT01302392|Secondary|Progression-free Survival|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||months||95% Confidence Interval|Median
51521|NCT01302392|Primary|Overall Survival|Time elapsed between the randomization date and the date of death. Participants who were still alive were censored at date when the subject is last known alive or the data cutoff date, whichever occurs earlier.|From randomization through the final analysis data cutoff with longest follow-up time of approximately 45 months. Median follow up times were 27.8 months and 29.8 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.||months||95% Confidence Interval|Median
51522|NCT01302366|Primary|Duration of Response (Excluding Patient Choice and Non-compliance)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years|All patients or the patients excluding personal choice or non-compliance||months||Full Range|Median
51523|NCT01302366|Secondary|Percentage of Patients Who Have Responded to TBL12|Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)|2 months|all patients||percentage of participants|||Number
51524|NCT01302366|Primary|Duration of Response (All Treated Patients)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years|||months||Full Range|Median
51525|NCT01302119|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
51526|NCT01302119|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
51527|NCT01302119|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
51528|NCT01302119|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.||participants|||Number
51529|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 12.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. Number of participants with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 12.||Percentage of participants|||Number
51530|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 4.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with baseline UUI >0 per 24 hours and non-missing change from baseline to Week 4.||Percentage of participants|||Number
51531|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
51532|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
51533|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
51534|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
51535|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
51536|NCT01302067|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.||Scores on a scale||Standard Error|Least Squares Mean
51537|NCT01302067|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.|UPS: single-item, self-administered validated questionnaire. Participant answered: “Which of the following would typically describe your experience when you have a desire to urinate?” on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.||Participants|||Number
51538|NCT01302067|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.||Participants|||Number
51539|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.||Participant||Full Range|Median
51540|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 4.||Participant||Full Range|Median
51541|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Standard Error|Least Squares Mean
51542|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Standard Error|Least Squares Mean
51543|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Full Range|Median
51544|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Full Range|Median
51545|NCT01302067|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Standard Error|Least Squares Mean
51546|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Full Range|Median
51547|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Full Range|Median
51682|NCT01300767|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51548|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.||Episodes per 24 hours||Standard Error|Least Squares Mean
51549|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.||Episodes per 24 hours||Standard Error|Least Squares Mean
51550|NCT01302067|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI >0 per 24 hours & non-missing change from BL to Week 12 were included.||Episodes per 24 hours||Standard Error|Least Squares Mean
51551|NCT01302054|Secondary|Percentage of Participants With No UUI Episodes (Diary Dry Rate)|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).||percentage of participants|||Number
51552|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||percentage of participants|||Number
51553|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week -2, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||percentage of participants|||Number
51554|NCT01302054|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
51555|NCT01302054|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
51556|NCT01302054|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12|UPS: single-item, self-administered validated questionnaire. Participant answered: “Which of the following would typically describe your experience when you have a desire to urinate?” on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||participants|||Number
51624|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 5h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-10 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5h after the procedure|||picogram/milliliter||Standard Deviation|Mean
51557|NCT01302054|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12|"PPBC: single-item, self-administered validated questionnaire. Participant answered: “Which of the following statements describes your bladder condition best at the moment? on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2)."|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.||participants|||Number
51558|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline urgency episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||episodes per 24 hours||Standard Deviation|Mean
51559|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline micturitions >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||micturitions per 24 hours||Standard Deviation|Mean
51560|NCT01302054|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).||episodes per 24 hours||Standard Deviation|Mean
51561|NCT01302054|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12(LOCF).||episodes per 24 hours||Standard Deviation|Mean
51562|NCT01302041|Secondary|PSA Doubling Time|PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.|From Baseline to Week 25|Safety Analysis Set with a positive PSA versus time slope|||||
51563|NCT01302041|Secondary|Time to PSA Progression|Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days).|Safety Analysis Set||days||Inter-Quartile Range|Median
51564|NCT01302041|Secondary|Time to PSA ≤ 0.1 ng/ml|"Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded.~Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method."|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days).|Safety Analysis Set||days||Inter-Quartile Range|Median
51565|NCT01302041|Secondary|Time to PSA ≤ 4 ng/ml|Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days).|Safety Analysis Set||days||Inter-Quartile Range|Median
51566|NCT01302041|Secondary|Time to PSA Decline ≥ 90%|Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days)|Safety Analysis Set||days||Inter-Quartile Range|Median
51567|NCT01302041|Secondary|Time to PSA Response|Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.|From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days)|Safety Analysis Set||days||Inter-Quartile Range|Median
51625|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)|||picogram/milliliter||Standard Deviation|Mean
51568|NCT01302041|Secondary|Maximum Decline From Baseline in PSA|The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to Week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.|Baseline to Week 25 and from Baseline up to the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929)|Safety Analysis Set||percent change||Standard Deviation|Mean
51569|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 0.1 ng/ml|"Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.~Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders."|Weeks 25, 49 and 97|Safety Analysis Set; Week 49 and 97 analyses include participants who were on study at each time point.||percentage of participants|||Number
51570|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 4 ng/ml|"Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.~Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders."|Weeks 25, 49 and 97|Safety Analysis Set; Week 49 and 97 analyses include participants who were on study at each time point.||percentage of participants|||Number
51571|NCT01302041|Secondary|Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level|"Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.~Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders."|Baseline and Weeks 25, 49 and 97|Safety Analysis Set; Week 49 and 97 analyses include participants who were on study at each time point.||percentage of participants|||Number
51572|NCT01302041|Secondary|Percentage of Participants With a PSA Response at Weeks 49 and 97|A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to Week 49 or Week 97 for any reason were treated as non-responders.|Baseline and Weeks 49 and 97|Safety Analysis Set||percentage of participants||95% Confidence Interval|Number
51573|NCT01302041|Secondary|Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|"Pharmacokinetic Analysis Set with available data at each time point (indicated by N)."||μg/mL||Standard Deviation|Mean
51574|NCT01302041|Secondary|Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|"Pharmacokinetic Analysis Set (participants who had taken at least 1 dose of study drug and who had at least 1 pharmacokinetic concentration value) with available data at each time point (indicated by N)."||μg/mL||Standard Deviation|Mean
51575|NCT01302041|Secondary|Percent Change From Baseline in Free Testosterone||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
51576|NCT01302041|Secondary|Percent Change From Baseline in Total Testosterone||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
51577|NCT01302041|Secondary|Percent Change From Baseline in Prolactin||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
51578|NCT01302041|Secondary|Percent Change From Baseline in Luteinizing Hormone (LH)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
51579|NCT01302041|Secondary|Percent Change From Baseline in Follicle-stimulating Hormone (FSH)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (Indicated by N)"||percent change||Standard Deviation|Mean
51580|NCT01302041|Secondary|Percent Change From Baseline in Estradiol||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
51581|NCT01302041|Secondary|Percent Change From Baseline in Dihydrotestosterone (DHT)||Baseline and Week 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
51582|NCT01302041|Secondary|Percent Change From Baseline in Dehydroepiandrosterone (DHEA)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
51583|NCT01302041|Secondary|Percent Change From Baseline in Androstenedione||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
51584|NCT01302041|Secondary|Percent Change From Baseline in Sex Hormone-binding Globulin (SHBG)||Baseline and Weeks 25 and 49|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
51585|NCT01302041|Secondary|Percent Change From Baseline in PSA||Baseline and Weeks 25, 49 and 97|"Safety Analysis Set with available data at each time point (indicated by N)"||percent change||Standard Deviation|Mean
51586|NCT01302041|Secondary|Number of Participants With Adverse Events|"Each adverse events (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs).~A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life-threatening~Resulted in persistent or significant disability/incapacity~Resulted in congenital anomaly or birth defect~Required inpatient hospitalization or led to prolongation of hospitalization~Other medically important events."|From first dose of study drug until 30 days after last dose. Adverse events with an onset date occurring within 2 years (i.e., before or on Day 730), as of the cut-off date of 28 December 2013, are reported.|Safety Analysis Set||participants|||Number
51587|NCT01302041|Primary|Percentage of Participants With a Prostate-specific Antigen (PSA) Response at Week 25|"A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory.~Participants with an unknown or missing response or who discontinued prior to Week 25 for any reason were treated as non-responders."|Baseline and Week 25|Safety Analysis Set (all participants who had taken at least 1 dose of study drug)||percentage of participants||95% Confidence Interval|Number
51588|NCT01301963|Secondary|Compare Need for Remobilization Between Mobilization Groups|Using the Chi-square test or Fisher's exact test, as appropriate.|Day 1||||||
51591|NCT01301963|Secondary|Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other|Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.|By day 1||||||
51592|NCT01301963|Secondary|Percentage of Patients Achieving Target Goal CD34+ Cells Dose||In =< 5 days of leukaphereses|Due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study|||||
51593|NCT01301963|Primary|Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg||In =< 2 days of leukaphereses|due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study|||||
51594|NCT01301950|Secondary|To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location||Intraoperative|No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0.|||||
51595|NCT01301950|Secondary|To Compare the Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures|Costs associated with surgery for conventional versus TruMatch® primary total knee replacements .|Intraoperative (Total duration of procedure)|No cost data were collected, resulting in a sample size of 0.|||||
51596|NCT01301950|Secondary|Turnover Time (Time to Clean Operating Room After Surgery is Completed)|Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes].|Intraoperative (Time to clean Operating Room after surgery is completed)|1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection.||minutes||Standard Deviation|Mean
51597|NCT01301950|Secondary|Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete|Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]|Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)|||minutes||Standard Deviation|Mean
51598|NCT01301950|Primary|Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements|Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).|Intraoperative (Time from first incision to first stitch)|||minutes||Standard Deviation|Mean
51599|NCT01301833|Secondary|Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||μU / mL||Standard Deviation|Mean
51600|NCT01301833|Secondary|Change From Baseline in Fasting Glucagon at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||pg / mL||Standard Deviation|Mean
51601|NCT01301833|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||mg / dL||Standard Deviation|Mean
51602|NCT01301833|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.||Percent||Standard Deviation|Mean
51603|NCT01301833|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 Weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.||participants|||Number
51604|NCT01301742|Secondary|Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.~The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
51605|NCT01301742|Primary|Total Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.~The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
51606|NCT01301742|Primary|Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.~The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
51608|NCT01301729|Secondary|Clinical Benefit Rate|Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||percentage of participants||95% Confidence Interval|Number
51609|NCT01301729|Secondary|Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses)||up to 28 months|Biomarker analysis was not performed as the eligible biomarker sample quantity was too limited for testing.|||||
51610|NCT01301729|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.|Up to 28 days after last infusion of the study drug (28 months)|Safety population is defined as all enrolled participants and have taken at least one dose of study drug.||percentage of participants|||Number
51611|NCT01301729|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.|Time from enrollment to the date of death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||months||95% Confidence Interval|Median
51612|NCT01301729|Secondary|Duration of Response|Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions.|From the time of PR or CR until the date of PD or death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study. Here, number of participants are the participants who had response.||months||95% Confidence Interval|Median
51613|NCT01301729|Secondary|Overall Response Rate|Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.||percentage of participants||95% Confidence Interval|Number
51614|NCT01301729|Primary|Progression-Free Survival (PFS)|PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.|From the date of informed consent to the date of death or progressive disease (up to 28 months)|Intention to treat (ITT) data set is defined as all the participants who are eligible through screening, register and enter the study.||months||95% Confidence Interval|Median
51615|NCT01301274|Secondary|ICU Length of Stay|ICU length of stay (in days)|180 days|||days||Standard Deviation|Mean
51616|NCT01301274|Secondary|Mechanical Ventilation Free Days at 28 Day of Admission|mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.|first 28 day after starting mechanical ventilation|||days||Standard Deviation|Mean
51617|NCT01301274|Secondary|Mortality at 28 Days|Mortality in both groups will be compared 28 days after admission|28 days after admission|The analysis was per intention to treat||participants|||Number
51618|NCT01301274|Primary|Serum Sodium Levels in Both Groups|Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion|first 48 hours|||mEq/L||Standard Deviation|Mean
51619|NCT01301092|Secondary|)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
51620|NCT01301092|Secondary|Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.||nanograms*hour/milliliter (ng*h/mL)||90% Confidence Interval|Geometric Mean
51621|NCT01301092|Primary|Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
51622|NCT01301092|Primary|Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.||nanograms*hour/milliliter/milligram||90% Confidence Interval|Geometric Mean
51623|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
51647|NCT01301079|Primary|Pain 150 Minutes|The scale measure pain after 150 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|150 minutes|||units on a scale||Standard Deviation|Mean
51626|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
51627|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
51628|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)|||picogram/milliliter||Standard Deviation|Mean
51629|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
51630|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure|||picogram/milliliter||Standard Deviation|Mean
51631|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)|||picogram/milliliter||Standard Deviation|Mean
51632|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence 24 h After the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the non dominant hand 24 h after the procedure|24 h after the procedure|||participants|||Number
51633|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence Before the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the nondominant hand before the procedure|Before the procedure (Baseline)|||participants|||Number
51634|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region 24 h After the Procedure|The evaluations using the soft brush were performed 2–3 cm from the incision in the periumbilical region (where the large trocar was placed) 24 h after the procedure|24 h after the procedure|||participants|||Number
51635|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region Before the Procedure|The evaluations using the soft brush were performed 2–3 cm from the incision in the periumbilical region (where the large trocar was placed) before the procedure|Before the procedure (Baseline)|||participants|||Number
51636|NCT01301079|Secondary|Extension of Hyperalgesia|The 300-g filament was used 24 hours after the operation to induce a stimulus and delineate the extent of hyperalgesia from the periumbilical region. The stimulus was started outside the periumbilical region, where no pain sensation was reported, and continued every 0.5 cm until the 4 points of the periumbilical scar were reached (top, right side, left side, and bottom). The first point where the patient complained of pain was marked. If no pain sensation was reported, the stimulus was terminated 0.5 cm from the incision. The distance of each point from the surgical incision was measured, and the sum of the distances of the points was determined.|24 hours after the procedure|||centimeter||Standard Deviation|Mean
51637|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure|||kilogram force/second||Standard Deviation|Mean
51638|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the surgery)|||kilogram force/second||Standard Deviation|Mean
51639|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure|||kilogram force/second||Standard Deviation|Mean
51640|NCT01301079|Primary|Pain 24 Hours|The scale measure pain after 24 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|24 hours|||units on a scale||Standard Deviation|Mean
51641|NCT01301079|Primary|Pain 18 Hours|The scale measure pain after 18 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|18 hours|||units on a scale||Standard Deviation|Mean
51642|NCT01301079|Primary|Pain 12 Hours|The scale measure pain after 12 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|12 hours|||units on a scale||Standard Deviation|Mean
51643|NCT01301079|Primary|Pain 6 Hours|The scale measure pain after 6 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|6 hours|||units on a scale||Standard Deviation|Mean
51644|NCT01301079|Primary|Pain 240 Minutes|The scale measure pain after 240 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|240 minutes|||units on a scale||Standard Deviation|Mean
51645|NCT01301079|Primary|Pain 210 Minutes|The scale measure pain after 210 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|210 minutes|||units on a scale||Standard Deviation|Mean
51646|NCT01301079|Primary|Pain 180 Minutes|The scale measure pain after 180 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|180 minutes|||units on a scale||Standard Deviation|Mean
51653|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the postoperative period (24h after the procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24h after the procedure|||gram||Standard Deviation|Mean
51654|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)|||gram||Standard Deviation|Mean
51655|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the postoperative period (24 hours after procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24 hours after procedure|||gram||Standard Deviation|Mean
51656|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)|||gram||Standard Deviation|Mean
51657|NCT01301079|Secondary|Morphine Consumption Within 24 h||24 hours|||milligram||Standard Deviation|Mean
51658|NCT01301079|Secondary|Time to First Morphine Supplementation||24 hours|||minutes||Full Range|Median
51659|NCT01301066|Primary|Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks||12 weeks minus baseline|modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment||mg/dL||Standard Deviation|Mean
51660|NCT01301027|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months|The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
51661|NCT01301027|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months|The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
51662|NCT01301027|Primary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months|The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
51663|NCT01301027|Primary|Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months|The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
51664|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Miscellaneous (4 questions): range 0 – 48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51683|NCT01300767|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51665|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Sexual function (2 questions): range 0 – 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51666|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Urinary (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51667|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Gastrointestinal tract (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51668|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Attention/Memory (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51669|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Perception/Hallucinations (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51684|NCT01300767|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51685|NCT01300767|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51686|NCT01300767|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|||Units on a Scale||Standard Deviation|Mean
51670|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Mood/Cognition (6 questions): range 0 – 72"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51671|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Sleep/Fatigue (4 questions): range 0-48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51672|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Cardiovascular (2 questions): range 0 – 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51673|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)|Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51674|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's Disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change from Baseline to end of Maintenance score indicates improvement.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51675|NCT01300819|Primary|Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score|The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson’s Disease (PD). The severity and frequency of the subject’s nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent [daily or all the time]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.||scores on a scale||Standard Deviation|Mean
51676|NCT01300767|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks|||Percent likely to purchase|||Number
51687|NCT01300767|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51688|NCT01300741|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Percent likely to purchase|||Number
51689|NCT01300741|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51690|NCT01300741|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51691|NCT01300741|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51692|NCT01300741|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51693|NCT01300741|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51694|NCT01300741|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51695|NCT01300741|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51696|NCT01300741|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51697|NCT01300741|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51698|NCT01300741|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
51699|NCT01300741|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses||Units on a Scale||Standard Deviation|Mean
51700|NCT01300728|Secondary|Mean Cognitive Performance at 24 Months|"24 month cognitive performance in treatment (IVIG/placebo) is measured by:~Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)~Scale from 0 to 85 (0 is best cognitive performance)~Score is the sum of 12 sub-scales.~Mini Mental State Exam (MMSE)~Scale from 0 to 30 (30 is best cognitive performance)~Score is the sum of 11 sub-scales.~Clinical Dementia Rating - Sum of Boxes (CDR-SB)~Scale is 0 to 18 (0 is best cognitive performance)~Score is the sum of 6 sub-scales"|24 month|||units on a scale||Standard Deviation|Mean
51743|NCT01300338|Primary|Mean Change in Diastolic Blood Pressure|Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months|||Millimeters of Mercury||95% Confidence Interval|Mean
51701|NCT01300728|Secondary|Mean Cognitive Performance at 12 Months|"12 month cognitive performance in treatment (IVIG/placebo) is measured by:~Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)~Scale from 0 to 85 (0 is best cognitive performance)~Score is the sum of 12 sub-scales.~Mini Mental State Exam (MMSE)~Scale from 0 to 30 (30 is best cognitive performance)~Score is the sum of 11 sub-scales.~Clinical Dementia Rating - Sum of Boxes (CDR-SB)~Scale is 0 to 18 (0 is best cognitive performance)~Score is the sum of 6 sub-scales"|12 months|||units on a scale||Standard Deviation|Mean
51702|NCT01300728|Secondary|Change in Ventricular Volume in Patients With Positive Cerebrospinal Fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer Signature|Mean ventricular volume (cubic centimeters) in patients with positive cerebrospinal fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer signature at 24 months following infusion|Baseline to 24 months following infusion|||cubic centimeters (cc)||Standard Deviation|Mean
51703|NCT01300728|Secondary|Number of Participants Who Converted From Amnestic Mild Cognitive Impairment (a-MCI) to Alzheimer Disease (AD)|The National Institute of Neurological and Communicative Disorders and Stroke - Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria were proposed in 1984 by NINCDS-ADRDA criteria for diagnosing Alzheimer Disease and Clinical Dementia Rating (CDR) will be used to determine conversion from a-MCI to AD.|Baseline to 24 months|||participants|||Number
51704|NCT01300728|Primary|Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI|"Change in ventricular volumetric as measured by MRI at baseline, 12, and 24 months following the first infusion of either 0.4 g/kg NewGam or 0.9% saline solution(placebo) every 14 days x 5.~Participants will also be classified as early MCI (EMCI) if baseline CDR-SB is less than 1.5, and late MCI (LMCI) if CDR-SB is greater than or equal to 1.5."|Baseline, 12, and 24 month MRI evaluation|"Annualized Percent Change in ventricular volume (APCV) at 12 and 24 months was computed as:~((12 or 24 month volume) - (Baseline volume))/(Baseline volume)/(Time (years) between Baseline and 12 or 24 month visit)"||percent change per participant year||Standard Deviation|Mean
51705|NCT01300650|Secondary|Rate of Adverse Events and Hospitalizations||14 days||||||
51706|NCT01300650|Secondary|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||14 days||||||
51707|NCT01300650|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)|The Duke Activity Status Index (DASI) is a scale that quantifies patients' ability to perform various tasks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores reflect improved activity or improved heart failure symptoms. Lower scores reflect worsened ability or worsened heart failure symptoms.|14 days|||units on a scale||Inter-Quartile Range|Median
51708|NCT01300650|Secondary|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||14 days||||||
51709|NCT01300650|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|"The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.~Change in VE/VCO2 slope was calculated as the change in VE/VCO2 slope between baseline and 14 days. We therefore calculated the difference between VE/VCO2 slope measurements that occurred at baseline and at 14 days (change in VE/VCO2 slope = VE/VCO2 slope [day 14] - VE/VCO2 slope [baseline])"|14 days|||(unitless)||Inter-Quartile Range|Median
51710|NCT01300650|Primary|Median Interval Change From Baseline in Peak VO2|"Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.~The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 [day 14] - Peak VO2 [baseline])"|14 days|||mL/kg/min||Inter-Quartile Range|Median
51711|NCT01300624|Secondary|Communicative Effectiveness Ratings|"This questionnaire (Lomas et al, 1989) was provided to persons who communicated with the treatment participant regularly (e.g., a spouse). They rated how well the participant was able to perform on 16 common communication tasks (e.g., participating in a conversation over coffee). They rated each scenario along a line that spanned between the two extremes of ability, from not at all able to as able as before the stroke. The line was 100 mm. To score responses, the place where they bisected the line was measured. An average of their responses across the 16 questions was calculated."|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||units on a scale||Standard Deviation|Mean
51712|NCT01300624|Secondary|Western Aphasia Battery|Standardized measure of aphasia severity|pre-treatment and post-treatment|||units on a scale||Standard Deviation|Mean
51713|NCT01300624|Primary|Complete Utterances in Discourse|Sentence in discourse that were relevant to topic and syntactically correct|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||percentage of complete utterances||Standard Deviation|Mean
51714|NCT01300624|Secondary|Verb Naming|Confrontation of 100 action pictures|pre-treatment and post-treatment|||percentage of correct naming||Standard Deviation|Mean
51715|NCT01300624|Secondary|Noun Naming|Confrontation naming of 162 objects|pre-treatment and post-treatment|||percentage of correct naming||Standard Deviation|Mean
51716|NCT01300624|Primary|Untrained Sentence Probes|Picture description with sentences containing untrained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||percentage of correct sentences||Standard Deviation|Mean
51717|NCT01300624|Primary|Trained Sentence Probe|Picture description task that include trained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)|||percentage of correct sentences||Standard Deviation|Mean
51718|NCT01300559|Primary|Hemoglobin Measurement g/dl|The primary hypothesis was that use of the Aquamantys coagulation system in addition to unipolar cautery results in less intraoperative Hb loss compared with unipolar cautery alone during multilevel spinal decompression and fusion surgery.Intraoperatively, shed blood will be collected into a Cell-saver device. Surgical sponges will be recovered in a container of citrated normal saline. Prior to processing the salvaged blood from the cell-saver device, hemoglobin concentration (g/dL) and volume (dL) of the salvaged blood will be measured, allowing calculation of hemoglobin loss in grams.|At the end of surgery|Based on pilot data, it was estimated that 29 patients per group would provide 90% power with = 0.01 to distinguish such a difference between groups. Therefore, the randomized study was planned for 60 patients.||hemoglobin g/dl||95% Confidence Interval|Mean
51719|NCT01300546|Secondary|Percent Change in Headache Days All Treatment Periods Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine headache days||Standard Deviation|Mean
51720|NCT01300546|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Day 121|||scores on a scale||Standard Deviation|Mean
51721|NCT01300546|Secondary|Migraine Disability Assessment Test (MIDAS)|"Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.|||scores on a scale||Standard Deviation|Mean
51722|NCT01300546|Secondary|Percent Change of Doses of Study Medication|% change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)]*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|12 Subjects did not take any triptans (Group A) or NSAIDs (Group B) during Baseline Period and were not included in Matched Pairs analysis of study medication taken.||percent change of study medication||Standard Deviation|Mean
51723|NCT01300546|Secondary|Doses of Study Medication|Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||doses of study medication||Standard Deviation|Mean
51724|NCT01300546|Secondary|Migraine Attacks With 50% Reduction|Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||participants|||Number
51725|NCT01300546|Secondary|Headache Days With Greater Than 50% Reduction|Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||participants|||Number
51726|NCT01300546|Secondary|Migraine Duration From Time of Treatment to Pain Free|"% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Percent change=[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine duration||Standard Deviation|Mean
51727|NCT01300546|Secondary|Migraine Duration From Onset to Pain Free|Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine duration||Standard Deviation|Mean
51728|NCT01300546|Secondary|Migraine Severity|Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine severity||Standard Deviation|Mean
51729|NCT01300546|Secondary|Migraine Attacks|Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|||percent change of migraine attacks||Standard Deviation|Mean
51744|NCT01300338|Primary|Mean Change in Systolic Blood Pressure|Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months|||Millimeters of Mercury||95% Confidence Interval|Mean
51730|NCT01300546|Primary|Percent Change of Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)|||percent change of headache days||Standard Deviation|Mean
51731|NCT01300455|Secondary|Mean AHI|"Evaluation of the effect of multiple dose administration of suvorexant on~AHI as measured by polysomnography. The AHI is an overall index of OSA severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 1|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction.||Events per hour||95% Confidence Interval|Least Squares Mean
51732|NCT01300455|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Sleep stages were determined by polysomnography.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
51733|NCT01300455|Secondary|Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80%|"Evaluation of the percentage of the night in which SaO2 is less than 90%, less~than 85% and less than 80% following multiple dose administration of~suvorexant and placebo. Total sleep time is the total of all REM and non-REM sleep in a sleep episode."|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Percentage of Total Sleep Time||95% Confidence Interval|Mean
51734|NCT01300455|Secondary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multidose dose suvorexant on mean SaO2 during total sleep time as measured by pulse oximetry. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
51735|NCT01300455|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 13 days|All participants were included in the Safety Population.||participants|||Number
51736|NCT01300455|Primary|Number of Participants With an Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.||participants|||Number
51737|NCT01300455|Primary|Mean Apnea-Hypopnea Index (AHI)|"Evaluation of the effect of multiple dose administration of suvorexant on~AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 4|Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.||Events per hour||95% Confidence Interval|Least Squares Mean
51738|NCT01300351|Secondary|Duration of Clinical Benefit|"Duration of clinical benefit (DoCB) will be evaluated only for patients who have CB, and is defined as the time from the date of randomisation until the date of disease progression or death from any cause, whichever is earlier.~Any patient who has not progressed or died by the date of DCO or who has been lost to follow up will be right censored at the date of their last evaluable disease assessment."|36 months|FAS||months||Inter-Quartile Range|Median
51739|NCT01300351|Secondary|Duration of Response|"Duration of response (DoR) will be evaluated only for patients who have an objective response, and is defined as the time from the date of first documentation of objective response (i.e., the initial visit at which CR or PR was recorded) until the date of disease progression or death due to any cause (whichever is earlier). The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR.~Any patient who has not progressed or died by the date of DCO, or who has been lost to follow up, will be right-censored at the date of their last disease assessment."|36 months|Evaluable for Response Set||months||Inter-Quartile Range|Median
51740|NCT01300351|Secondary|Clinical Benefit Rate|A clinical benefit (CB) responder is defined as a patient having a best overall response of either CR, PR or SD for at least 24 weeks per RECIST v1.1. As tumour assessments can occur ± 2 weeks of the specified time point, the CBR is defined as the proportion of patients in the FAS who have CB ≥ 22 weeks (or 154 days).|36 months|FAS||patients|||Number
51741|NCT01300351|Secondary|Objective Response Rate|The ORR is defined as the proportion of all randomized patients with measurable disease at baseline who have a best objective tumour response of either CR or PR per RECIST v1.1.|36 months|Evaluable for Response Set, included all patients in the FAS with measurable disease at baseline.||patients|||Number
51742|NCT01300351|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions, or death (by any cause in the absence of progression). The primary analysis for PFS was the log rank test stratified by last endocrine therapy received prior to fulvestrant (AO vs. AI). The treatment effect was estimated using the HR of 500 mg fulvestrant to 250 mg fulvestrant together with the corresponding 95% CI and p value.|36 months|FAS: all randomised patients and compared the treatment groups on the basis of randomised treatment, regardless of treatment actually received.||months||Inter-Quartile Range|Median
51749|NCT01300286|Primary|Fibrinogen Level Change|Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.|Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)|||mg/dl||Standard Deviation|Mean
51750|NCT01300260|Other Pre-specified|Area Under the Insulin Concentration-time Curve (AUC)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUCG data.||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
51751|NCT01300260|Secondary|Insulin Maximum Concentration (Cmax)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmaxG data.||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
51752|NCT01300260|Primary|Insulin Area Under the Curve (AUC) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 post dose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(10-180) second response phase data.||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
51753|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(10-180) second response phase data.||picomole per liter (pmol/L)]||95% Confidence Interval|Geometric Mean
51754|NCT01300260|Primary|Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(0-10) first phase response data.||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
51755|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(0-10) first response phase data.||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
51756|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Recovery|B-cell recovery was defined as CD19 >=0.07×10^9/L, where participants’ CD19 were previously depleted. B-cell recovery was only considered possible when the participant had received the last dose of study treatment.|Follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population||percentage of participants|||Number
51757|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Depletion|B-cell depletion was defined as cluster of differentiation 19 (CD19) <0.07×10^9/L and could occur only after at least one dose of study drug had been administered.|Up to the end of the treatment period, and follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population||percentage of participants|||Number
51759|NCT01300247|Secondary|Percentage of Participants Who Were Alive and Progression Free|Progressive disease assessed using IWCLL: >=50% increase in the absolute number of circulating lymphocytes to at least 5x10^9/L; Appearance of new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology.|Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.||percentage of participants|||Number
51760|NCT01300247|Secondary|Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines|DOR for participants with OR: time from first CR, CRi or PR to disease progression (DP), relapse, or death, assessed by the investigator. DP: >=50% increase in lymphocytes to at least 5x10^9/L;new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology. CR:peripheral blood lymphocytes (PBL) <4x10^9/L; no lymphadenopathy; no hepatomegaly or splenomegaly (below relevant costal margin); no symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR: >=50% decrease in PBL, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi: met CR criteria, lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery.|From first documented objective response up to disease progression or relapse or death, whichever occurred first (up to approximately 6 months)|Safety evaluable population.||percentage of participants||95% Confidence Interval|Number
51761|NCT01300247|Secondary|Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines|Objective response was defined as a complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR), as determined by investigator. CR:required peripheral blood lymphocytes <4x10^9/L; absence of lymphadenopathy; no hepatomegaly or splenomegaly by physical examination as determined by measurement below relevant costal margin; absence of disease/constitutional symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR:Greater than equal to (>=) 50% decrease in peripheral blood lymphocyte count, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi:met all CR criteria including confirmed lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery. The 95% confidence interval (CI) was estimated by Clopper-Pearson method. The end of treatment response visit occurred 2-3 months after end of treatment.|Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to approximately 9 months)|Safety evaluable population||percentage of participants||95% Confidence Interval|Number
51762|NCT01300247|Secondary|Half-Life of Obinutuzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
51763|NCT01300247|Secondary|Volume of Distribution of Obinutuzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
51764|NCT01300247|Secondary|Clearance of Obinutuzumab|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on C1D1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
51765|NCT01300247|Secondary|Trough Plasma Concentration (Ctrough) of Obinutuzumab||Pre-dose on C1D1, C1D3, 8, 15, C2D1, C4D1, C6D1|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
51766|NCT01300247|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab||Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.|||||
51767|NCT01300247|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Obinutuzumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The pharmacokinetic (PK) variables could not be calculated as the PK samples were not collected accurately.|||||
51768|NCT01300247|Primary|Number of Participants With Human Anti-Human Antibodies (HAHAs)||Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)|Safety evaluable population||participants|||Number
51769|NCT01300234|Secondary|Number of Participants in the Indicated Category for Hepatic Laboratory Abnormalities|"The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter."|Baseline; up to Week 48/Early Withdrawal|Safety Analysis Population||participants|||Number
51974|NCT01298518|Secondary|Change From Baseline in Fasting Net Triglycerides at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting net triglycerides value. Here, 'n' is participants evaluable at specified time points for each group.||mg/dL||Standard Deviation|Mean
51770|NCT01300234|Secondary|Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus|The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Serum creatinine: Grade 1, >=133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, >177 to 265 µmoles/Liter, Grade 3, >265 to 530 µmoles/Liter, Grade 4, >530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to <0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to <0.63 mmoles/L, Grade 4, <0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmol/L; the upper limit for a Grade 2 abnormality is 0.80 mmol/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range.|up to Week 48/Early Withdrawal|Safety Analysis Population||participants|||Number
51771|NCT01300234|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)|TE grade 3 or grade 4 LAs are defined as values that increase by >=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Sodium: hyponatremia, Grade (G) 3=121-<125 millimoles per Liter (mmol/L), G4=<121 mmol/L; hypernatremia, G3=>154-159 mmol/L, G4=>159 mmol/L. Phosphate: hypokalemia, G3=2.0-<2.5 mmol/L, G4=<2,0 mmol/L; hyperkalemia, G3=>6.5-7 mmol/L, G4=>7.0 mmol/L. Alanine aminotransferase/aspartate aminotransferase: G3=>5.00-10.00 × upper limit of normal (ULN), G4=>10.0 × ULN. Bilirubin: G3=>2.5-5.0 × ULN, G4=>5.0 × ULN. Creatinine kinase: G3=10.0-<20.0 × ULN, G4=>=2.0 × ULN. Hemoglobin: 70-<90 grams per Liter (g/L), G4=<70 g/L. Platelets: G3=25-<50 GI (10^9)/L, G4=<25 GI/L. Neutrophils: G3, 0.50-<0.75 GI/L, G4=<0.50 GI/L. Prothrombin time: G3=>1.50-3.00 × ULN, G4=>3.00 × ULN.|Baseline; up to Week 48/Early Withdrawal|Safety Analysis Population||participants|||Number
51772|NCT01300234|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Refer to the general AE/SAE module for a complete list of AEs and SAEs.|up to Week 48|Safety Analysis Population: all participants who received at least one dose of study medication and had at least one post-Baseline safety assessment||participants|||Number
51773|NCT01300234|Secondary|Number of Participants With Virological Breakthrough at Week 48|The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Week 48 was assessed. Virological breakthrough is defined as an HBV DNA increase of >=1 log10 copies/mL above the treatment nadir, confirmed on two consecutive visits.|Week 48|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
51774|NCT01300234|Secondary|Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48|Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 weeks apart. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Week 24 to Week 48|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis. A non-completers equal failures approach was used for analysis.||participants|||Number
51775|NCT01300234|Secondary|Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24 and 48|HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Weeks 24 and 48|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis.||participants|||Number
51776|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24 and 48|Hepatitis B surface Antigen (HBsAg) loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Weeks 24 and 48|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis.||participants|||Number
51777|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24 and 48|HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported.|Week 24 and 28|ITT Population. Only those participants available at the indicated time points were assessed. A non-completers equal failures approach was used for analysis.||participants|||Number
51788|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
51814|NCT01299454|Secondary|Incidence of Suicidality, Suicidal Behaviour or Suicidal Ideation as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The Baseline version of the C-SSRS was administered at Screening. The Since Last Visit version of the C-SSRS was administered on Day 1 at predose and on Days 4 and 7.|Day 1, Day 4, Day 7|Suicidality, suicidal behaviour or suicidal ideation are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participants|||Number
51778|NCT01300234|Secondary|Number of Participants With Histological Improvement at Week 48 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2|Histological improvement is defined as a reduction of >=2 points in the KNS with no increase in fibrosis at Week 48 in participants with a Baseline KNS >=2, which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal+/-bridging necrosis (scored as 0 [best], 1, 3, 4, 5, 6, or 10 [worst]); and intralobular degeneration/focal necrosis, portal inflammation, and fibrosis (all scored as 0-4). The necroinflammatory score (0 [best] to 14 [worst]) is the combined score for necrosis (0-10) plus inflammation (0-4; the participant is scored for only one inflammatory condition). Liver biopsy was done at selected sites. Liver biopsy slides within 6 months prior to randomization could be accepted as the Baseline evaluation.|Baseline and Week 48|"ITT Population. Only those participants who had a Baseline Knodell necroinflammatory score >=2 were included in this analysis. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative participants. At least 60 participants in each treatment arm were planned to undergo liver biopsy."||participants|||Number
51779|NCT01300234|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 in Participants Who Had Abnormal ALT at Baseline|Participants who had abnormal ALT at Baseline and had normalized ALT at Week 48 were assessed. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter [U/L]). Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48.|Baseline and Week 48|"ITT Population. Only those participants who had abnormal ALT at Baseline were included in this analysis. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative participants."||participants|||Number
51780|NCT01300234|Secondary|Log 10 Copies/mL Reduction From Baseline HBV DNA at Week 48|The log 10 copies/mL reduction from Baseline HBV DNA at Week 48 in the HBeAg-positive and HBeAg-negative population was assessed. This report includes data up to and including Week 48. Long-term efficacy data (up to Week 240) will eventually be reported. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48.|Baseline and Week 48|"ITT Population. Only those participants available at the indicated time point were assessed. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative participants."||log 10 copies/mL||Standard Deviation|Mean
51781|NCT01300234|Secondary|Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240|The number of participants with HBV DNA <400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48.|Weeks 96, 144, 192, and 240||03/2017||||
51782|NCT01300234|Primary|Participants With Hepatitis B Virus (HBV) DNA <400 Copies/Milliliter (mL) at Week 48|The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious.|Week 48|"Intent-to-Treat (ITT) Population: all randomized participants (par.) who received at least one dose of study medication. Only those par. available at the indicated time point were assessed. The ns in the category titles represent the number of HBeAg-positive and HBeAg-negative par. A non-completers equal failures approach was used for analysis."||participants|||Number
51783|NCT01299961|Secondary|12 Month Change in Gray-scale Ultrasound (GSUS)|There were seven different joints in the hands and wrists evaluated to score the GSUS.|baseline, 12 months|||units on a scale||Standard Deviation|Mean
51784|NCT01299961|Secondary|12 Month Change in Power Doppler Ultrasound (PDUS) Scores|There were seven different joints in the hands and wrists evaluated to score the PDUS.|baseline, 12 months|As stated previously||units on a scale||Standard Deviation|Mean
51785|NCT01299961|Primary|12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score|The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.|baseline, 12 months|Total of 19 patients completed 12 mos||units on a scale||Standard Deviation|Mean
51786|NCT01299909|Primary|Smoking Abstinence|Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.|24 weeks post quit day|analysis was conducted on all randomized participants||participants|||Number
51787|NCT01299896|Primary|Effectiveness of CTQ vs UC|We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.|Two (2) year period|||percentage of participants per arm|||Number
51813|NCT01299480|Primary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants||1 month after Injection 4|||percentage of participants|||Number
51875|NCT01298661|Secondary|"First Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
51789|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng/mL||Standard Deviation|Mean
51790|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng*hr/mL||Standard Deviation|Mean
51791|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
51792|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1|Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng/mL||Standard Deviation|Mean
51793|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma|Area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||ng*hr/mL||Standard Deviation|Mean
51794|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
51795|NCT01299805|Primary|Maximum Concentration of 5-HT in Cerobrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg/mL||Standard Deviation|Mean
51796|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg*hr/mL||Standard Deviation|Mean
51797|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||hours||Standard Deviation|Mean
51798|NCT01299805|Primary|Maximum Concentration of 5-HT in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg/mL||Standard Deviation|Mean
51799|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."||pg*hr/mL||Standard Deviation|Mean
51800|NCT01299584|Secondary|Number of Participants With the Indicated Unexpected Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.|24 hours|ITT Population||participants|||Number
51801|NCT01299584|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population||participants|||Number
51802|NCT01299584|Secondary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population||participants|||Number
51803|NCT01299584|Primary|Number of Participants With an Unexpected Serious Adverse Event|A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.|24 hours|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments||participants|||Number
51804|NCT01299571|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|6 months|ITT Population||participants|||Number
51805|NCT01299571|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|6 months|ITT Population||participants|||Number
51806|NCT01299571|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|6 months|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments||participants|||Number
51807|NCT01299480|Other Pre-specified|Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer||1 month after Injection 2, 3, 4|Results were not reported because a decision was made a priori that, although the fold rise outcome measure will still be performed, it will not be performed as a secondary outcome measure. Therefore it was moved from a secondary outcome measure in an earlier protocol version to an exploratory outcome measure in the final protocol.|||||
51808|NCT01299480|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Injection 1, 1 Month after Injection 2, 3, 4|||percentage of participants|||Number
51809|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ||Before Injection 1, 1 Month after Injection 2, 3, 4|||percentage of participants|||Number
51810|NCT01299480|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)||Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4|||titer||95% Confidence Interval|Geometric Mean
51811|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants||1 month after Injection 4|||percentage of participants|||Number
51812|NCT01299480|Primary|Percentage of Participants Reporting At Least 1 Adverse Event (AE)||Injection 1 up to 1 month after Injection 4|Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.||percentage of participants|||Number
51815|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Serum Chemistry, Hematology and Urinalysis Parameters.|Hematology, serum chemistry, and urinalysis, including prothrombin time, international normalized ratio, partial thromboplastin time, and activated partial thromboplastin time, were completed at Screening, Day -1, Day 3 (48 hours postdose), and Day 8 (168 hours postdose)/ET.|Day -1 to Day 8|The abnormal values of laboratory values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participant|||Number
51816|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Parameters.|Electrocardiograms were performed at Screening, Day -1, and Day 1 at predose (in triplicate; within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Standard 12-lead ECGs were performed after the subject was supine and at rest for ≥ 10 minutes prior to the ECG.|Day-1 to Day 8|The abnormal values of ECG values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participants|||Number
51817|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Vital Signs Parameters.|Vital signs (including blood pressure, heart rate, temperature, and respiratory rate) were assessed at Screening, Day -1, Day 1 at predose (within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Blood pressure and heart rate were taken with the subject in the supine (performed first), sitting, and standing|Day -1 to Day 8|The abnormal values of vital signs values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.||Participants|||Number
51818|NCT01299454|Secondary|Number of Adverse Events (AEs) Reported|AEs were captured for all participants from the time the ICF was signed until the end of the study|From the time the Informed Consent Form was signed, throughout the 8 day study up to 30 days after study drug administration.|Participants who received at least one dose of study drug were included in the safety analysis.||Events|||Number
51819|NCT01299454|Secondary|CLr for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
51820|NCT01299454|Secondary|fe,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||% metabolite excreted in urine||Standard Deviation|Mean
51821|NCT01299454|Secondary|Ae,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng||Standard Deviation|Mean
51822|NCT01299454|Secondary|t1/2,z for DM-3411 Metabolite|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The t1/2,z was determined as (ln2)/λz."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Standard Deviation|Mean
51823|NCT01299454|Secondary|Tmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Tmax is the time taken to reach highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Full Range|Median
51824|NCT01299454|Secondary|Cmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Cmax is the highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
51825|NCT01299454|Secondary|AUC∞ for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The AUC∞ were estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
51826|NCT01299454|Secondary|AUCt for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)~The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
51827|NCT01299454|Secondary|Fraction of Systemically Available Brexpiprazole Excreted Into the Urine (fe,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose..~The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||% of drug in urine||Standard Deviation|Mean
51828|NCT01299454|Secondary|Cumulative Amount of Brexpiprazole Excreted Into the Urine (Ae,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng||Standard Deviation|Mean
51829|NCT01299454|Secondary|Renal Clearance (CLr) of Brexipiprazole|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
51830|NCT01299454|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The t1/2,z was determined as (ln2)/λz.~Terminal-phase elimination half-life is the time measured for the plasma concentration to decrease by one half."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Standard Deviation|Mean
51831|NCT01299454|Secondary|Apparent Unbound Clearance of Brexpiprazole From Plasma After Extravascular Administration (CLu/F)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The value of CLu/F (brexpiprazole only) was determined as dose normalized unbound area under the concentration-time curve from time zero to infinity (Dose/AUC∞,u)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
51832|NCT01299454|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu)|Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||% unbound drug in the urine||Standard Deviation|Mean
51833|NCT01299454|Secondary|Apparent Clearance of Brexpiprazole From Plasma After Extravascular Administration (CL/F)|"The value of CL/F (brexpiprazole only) was determined as Dose/AUC∞.~Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
51834|NCT01299454|Secondary|Time to Cmax of Brexiprazole (Tmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.~Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||h||Full Range|Median
51835|NCT01299454|Secondary|Maximum Plasma Concentration of Brexpiprazole (Cmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Cmax is the highest measured concentration of the drug during the dosing interval.~Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
51836|NCT01299454|Secondary|Area Under the Concentration Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).~The AUC∞ was estimated using the linear trapezoidal rule"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
51837|NCT01299454|Secondary|Area Under the Curve of Brexpiprazole Calculated to the Last Observable Concentration at Time t (AUCt)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
51838|NCT01299454|Primary|Unbound Maximum Plasma Concentration of Brexpiprazole (Cmax,u)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Cmax,u is the highest measured unbound plasma concentration during the dosing interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
51839|NCT01299454|Primary|Unbound Brexpiprazole AUC Calculated From Time Zero to Infinity (AUC∞,u)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
51840|NCT01299454|Primary|Unbound Brexpiprazole Area Under the Concentration Time Curve (AUC) Calculated to the Last Observable Concentration at Time t (AUCt,u)|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/Early termination (ET).|Day 1 to Day 8|Pharmacokinetics (PK) set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.||nanograms.hours/mL (ng*h/mL)||Standard Deviation|Mean
51841|NCT01299389|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
51898|NCT01298648|Secondary|Remission Rate at Week 4, Week 8, and Week 24|The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.|Baseline, Week 4, Week 8, and Week 24|Participants with available data at each time point.||percentage of participants|||Number
51842|NCT01299389|Secondary|Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
51843|NCT01299389|Secondary|Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
51844|NCT01299389|Secondary|Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28, higher score indicates greater severity.|Baseline and Week 13 or early discontinuation (ED)|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Standard Deviation|Mean
51845|NCT01299389|Secondary|Participants With Response to the Treatment as Per PANSS Total Score.|Participants with response were defined as those participants who shows 30 percent or more and 20 percent or more reduction in PANSS total score.|up to Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||participants|||Number
51846|NCT01299389|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.||units on a scale||Full Range|Median
51847|NCT01299389|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|Full Analysis Set (FAS) population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. Last Observation Carried Forward (LOCF) method was used.||units on a scale||Standard Deviation|Mean
51848|NCT01299376|Secondary|Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
51849|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during extension period.||Percentage of Participants|||Number
51850|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
51851|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
51852|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
51853|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.||Percentage of Participants|||Number
51854|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
51855|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
51856|NCT01299376|Primary|Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
51857|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
51858|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.||Percentage of Participants|||Number
51859|NCT01299376|Primary|Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data||mmHg||95% Confidence Interval|Least Squares Mean
51860|NCT01299103|Primary|Adverse Events|The rate of adverse events occurring in treatment subjects will be assessed.|90 days post treatment|||number of adverse events reported|||Number
51969|NCT01298518|Secondary|Time to Cmax (Tmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Tmax value.||hr||Full Range|Median
51970|NCT01298518|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmin value.||ng/mL||Standard Deviation|Geometric Mean
51861|NCT01299103|Primary|Fitzpatrick Wrinkle Assessment|Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease|change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.|||units on a scale, change in Fitzpatrick||Standard Deviation|Mean
51862|NCT01299090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The rate of adverse events will be assessed throughout the duration of the study|90 days post treatment|||participants|||Number
51863|NCT01299090|Primary|Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment|"Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study.~The measurement is for percentage of patients who showed improvement"|90 days post treatment|||percentage of participants|||Number
51864|NCT01299077|Secondary|Visual Analogue Scale (VAS) Score|Each patient is Scored on VAS at baseline and two weeks. VAS is the abbreviation of visual analogue score. There is no subscale in VAS. The maximum value of vas is 10 and the minimum is 0. This is self-evaluation method to present the severity of patient pain. More score number, more pain.|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Scores on VAS||Standard Deviation|Mean
51865|NCT01299077|Secondary|Japanese Orthopedic Association (JOA) Score|"Each patient is Scored on JOA at baseline and two weeks. JOA is short for Japanese Orthopedic Association, which consists of 12 items: low back pain, lower extremity pain and numbness, walking ability, straight leg raising, muscle strength, sensory and etc. The first 3 item’s scores are range from 0 to 3 and the others are from 0 to 2. Higher score means better condition.~All of these items scores are combined for a total overall JOA score, which is range from 0 to 27."|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Scores on JOA||Standard Deviation|Mean
51866|NCT01299077|Secondary|Safety Data During Triple Therapy.|Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Percentage of participants|||Number
51867|NCT01299077|Secondary|Onset Time of Symptom Relief.|Kaplan-Meier Estimates for the Average Onset Time of Symptom Relief. In this case the onset time of symptom relief was defined as the days between the end of triple therapy and the symptom improvement reported by patients.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||Average Days of Onset Time||Standard Deviation|Mean
51868|NCT01299077|Primary|Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).|The measurement of overall satisfaction degree was in three scales, that was satisfactory, just so so and dissatisfactory. The measurement was estimated by both the physicians and the patients respectively.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.||percentage of participants|||Number
51869|NCT01299025|Secondary|Change in the 12 Item Walking Scale From Day 1 to Day 42|The 12 item walking scale is a self-rating scale of walking limitations. The scale includes 12 items that each are scores from 1 to 5, where 5 is extremely limited. Scores are added and transformed to a scale from 0-100. 0 indicates no limitation and 100 extremely limited.|Measured at day 1 and day 42, before and after the training|||Scores on a scale||Standard Deviation|Mean
51870|NCT01299025|Secondary|Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42|The ABC scale is a self-rating scale of balance activities in everyday Life. It includes 16 items. The patient rates his/her performance from 0-100. Score on each item are summed an divided by 16. Minimum score is 0 and maximum score 100. A higher score indicate higher confidence in ones balance and walking capacity.|Measured at day 1 (before training) and day 42 (after training)|||Scores on a scale||Standard Deviation|Mean
51871|NCT01299025|Secondary|Change in Score on the Dynamic Gait Index From Day 1 to Day 42|The Dynamic Gait index consists of 8 items. Performance on each item is rated from 0 (severe impairment) to 3 (nomal performance). Minimum total score is 0 and maximum 24. Higher scores indicate better walking and balance performance.|Measured at day 1 (before training) and day 42 (after training)|||Scores on a scale||Standard Deviation|Mean
51872|NCT01299025|Primary|Change in Timed Up and Go Test From Day 1 to Day 42|Change in seconds on the Timed Up and Go test (TUG). In the TUG test time is taken from rising from a chair, walking 3 meters, turning,walking back and sitting down.|Measured at day 1 (before the training period) and at day 42 (after the training period)|||seconds||Standard Deviation|Mean
51873|NCT01298661|Secondary|"Third Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||bpm||Standard Deviation|Mean
51874|NCT01298661|Secondary|"Second Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
51876|NCT01298661|Secondary|"Third Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||bpm||Standard Deviation|Mean
51877|NCT01298661|Secondary|"Second Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor at rest and every two minutes of the test."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
51878|NCT01298661|Secondary|"First Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||bpm||Standard Deviation|Mean
51879|NCT01298661|Secondary|"Third Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||% of hemoglobin||Standard Deviation|Mean
51880|NCT01298661|Secondary|"Second Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter ."|First day or second day of the protocol (random) ,30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
51881|NCT01298661|Secondary|"First Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
51882|NCT01298661|Secondary|"Third Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||% of hemoglobin||Standard Deviation|Mean
51883|NCT01298661|Secondary|"Second Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|,First day or second day of the protocol (random) 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
51884|NCT01298661|Secondary|"First Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||% of hemoglobin||Standard Deviation|Mean
51885|NCT01298661|Secondary|"Third Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 2, the patient will step up down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||units on a scale||Full Range|Median
51886|NCT01298661|Secondary|"Second Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute.The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
51971|NCT01298518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmax value.||ng/mL||Standard Deviation|Geometric Mean
51887|NCT01298661|Secondary|"First Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
51888|NCT01298661|Secondary|"Third Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||units on a scale||Full Range|Median
51889|NCT01298661|Secondary|"Second Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
51890|NCT01298661|Secondary|"First Six Minute Walk Test Exertion Perception"|"This test was conducted by the Rater 1, the subject walked as far as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||units on a scale||Full Range|Median
51891|NCT01298661|Secondary|"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity Index (BODE Index)"|"It was evaluated only in the COPD patients. BODE index is a prognostic index used in COPD patients, it is a 0-10 scale, where lower values means better prognostic. It is composed by other commonly used evaluations tools in COPD, Forced Expiratory Volume in the First second (from spirometry); classification in the scale ranging from 0-3, Body-mass index, classification in the scale ranging from 0-1; Six-minute walk test distance, classification in the scale ranging from 0-3 and referred dyspnea, classification in the scale ranging from 0-3.~It was only used the total score (0-10)"|Second day|2 COPD were excluded since they did not appeared in the second day of evaluation. The other two populations were not verified, since the measure is specific for COPD patients||units on a scale||Inter-Quartile Range|Median
51892|NCT01298661|Secondary|"Third Six Minute Walk Test Distance"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||meter||Standard Deviation|Mean
51893|NCT01298661|Secondary|"Second Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the first or second day of evaluation (random), 30 minutes after the first 6MWT.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||meter||Standard Deviation|Mean
51894|NCT01298661|Secondary|"First Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||meter||Standard Deviation|Mean
51895|NCT01298661|Primary|"Third Six Minute Step Test Performance"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.||steps||Standard Deviation|Mean
51896|NCT01298661|Primary|"Second Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the first or second day of evaluation (random), 30 minutes after the first 6MST.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||steps||Standard Deviation|Mean
51897|NCT01298661|Primary|"First Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. The performance will be evaluated by the number of the steps."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.||steps||Standard Deviation|Mean
51899|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 24|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 24|Participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
51900|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 8|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 8|Participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
51901|NCT01298648|Secondary|Improvement Rating by Investigator at Week 24|Overall response rating, according to investigator’s subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.|Week 24|||percentage of participants|||Number
51902|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 4|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 4|Participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
51903|NCT01298648|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|24 weeks|Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.||participants|||Number
51904|NCT01298544|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL, 36 Months After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population||Percentage of participants||95% Confidence Interval|Number
51905|NCT01298544|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
51906|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Weeks 12 and 16|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||cm||Standard Deviation|Mean
51907|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 8|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||cm||Standard Error|Least Squares Mean
51908|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 4|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||cm||Standard Error|Least Squares Mean
51909|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 16|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51910|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 12|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51911|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51912|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51913|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Weeks 12 and 16|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51914|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51915|NCT01298531|Other Pre-specified|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51916|NCT01298531|Other Pre-specified|Number of Participants With PASS at Weeks 4, 12 and 16|PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51917|NCT01298531|Other Pre-specified|Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8|PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51918|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16|MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51919|NCT01298531|Other Pre-specified|Number of Participants With MCII at Weeks 4, 12 and 16|MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51920|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8|MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51921|NCT01298531|Other Pre-specified|Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51922|NCT01298531|Other Pre-specified|Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16|Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Tender joints||Standard Deviation|Mean
51923|NCT01298531|Other Pre-specified|Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16|Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Swollen joints||Standard Deviation|Mean
51924|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 16|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51975|NCT01298518|Secondary|Change From Baseline in Fasting Insulin at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting insulin value. Here, 'n' is participants evaluable at specified time points for each group.||micro-IU/mL||Standard Deviation|Mean
51925|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 12|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51926|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 8|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51927|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 4|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51928|NCT01298531|Other Pre-specified|Change From Baseline in PGA at Weeks 12 and 16|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51929|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 8|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51930|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 4|The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51931|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51932|NCT01298531|Secondary|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51933|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51934|NCT01298531|Other Pre-specified|Change From Baseline in BASFI at Week 8|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51935|NCT01298531|Other Pre-specified|Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51936|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51937|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 8|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51938|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 4|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51939|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51940|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 8|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51941|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 4|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51942|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Weeks 12 and 16.|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51943|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Week 8|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51944|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51972|NCT01298518|Secondary|Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28|Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 12 to 16 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-dinner glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
51945|NCT01298531|Secondary|Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.||Scores on a scale||Standard Error|Least Squares Mean
51946|NCT01298531|Secondary|Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.||Scores on a scale||Standard Error|Least Squares Mean
51947|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on a scale||Standard Deviation|Mean
51948|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Week 8.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51949|NCT01298531|Secondary|Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51950|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Units on scale||Standard Deviation|Mean
51951|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Week 8.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51990|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.||Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with HIP BMD measurements both at baseline and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
51952|NCT01298531|Secondary|Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51953|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
51954|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51955|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
51956|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51957|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
51958|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51959|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.|Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.||Participants|||Number
51960|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Week 8.|Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Participants|||Number
51973|NCT01298518|Secondary|Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28|Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 6 to 10 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-lunch glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
51961|NCT01298531|Secondary|Change From Baseline in Mini BASDAI at Week 8 (AUC).|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. The efficacy analysis was based on the ITT population. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis.||Unit on a scale * days||Standard Error|Least Squares Mean
51962|NCT01298531|Secondary|Number of Participants Using NSAIDs at Week 8.|Participants who received NSAIDs at Week 8 were reported.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.||Participants|||Number
51963|NCT01298531|Secondary|Change From Baseline in BASDAI Score at Weeks 12 and 16.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.||Units on a scale||Standard Deviation|Mean
51964|NCT01298531|Secondary|Change From Baseline in BASDAI at Week 8|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51965|NCT01298531|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Least Squares Mean
51966|NCT01298531|Secondary|Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.|The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.||Unit on a scale * days||Standard Error|Least Squares Mean
51967|NCT01298531|Primary|Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 8|The Intent To Treat (ITT) population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through last observation carried forward (LOCF).||Scores on a scale||Standard Error|Least Squares Mean
51968|NCT01298518|Secondary|Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110|"Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.~AUC (0-24) was computed using the linear trapezoidal method."|24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 AUC(0-24) value.||ng*hr/mL||Standard Deviation|Geometric Mean
51976|NCT01298518|Secondary|Change From Baseline in Fasting Glucose at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting glucose value. Here, 'n' is participants evaluable at specified time points for each group.||mg/dL||Standard Deviation|Mean
51977|NCT01298518|Secondary|Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PYY area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||pg*hr/mL||Standard Deviation|Mean
51978|NCT01298518|Secondary|Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 GIP area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||pg*hr/mL||Standard Deviation|Mean
51979|NCT01298518|Secondary|Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 total amide GLP-1 and active GLP-1 area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||pmol*hr/L||Standard Deviation|Mean
51980|NCT01298518|Secondary|Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT net triglyceride area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
51981|NCT01298518|Secondary|Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT C-peptide area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||ng*hr/mL||Standard Deviation|Mean
51982|NCT01298518|Secondary|Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT insulin area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||micro-IU*hr/mL||Standard Deviation|Mean
51983|NCT01298518|Secondary|Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28|APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.|Baseline (Day -1); 24 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 APG value. Here, 'n' is participants evaluable at specified time points for each group.||mg/dL||Standard Deviation|Mean
51984|NCT01298518|Primary|Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT glucose area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.||mg*hr/dL||Standard Deviation|Mean
51985|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.||Month 1-6 (depending on duration of chemotherapy) and month 13-18|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
51986|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion||Baseline and month 1-6 (depending on duration of chemotherapy)|Patients with LS BMD measurements both at baseline (before chemotherapy commencement) and at chemotherapy completion||percentage of change||95% Confidence Interval|Mean
51987|NCT01298362|Secondary|Bone Fracture Rate||During the 12 months of AI Therapy|All patients with available 12 month follow-up during AI treatment||participants|||Number
51988|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with HIP BMD measurements both at AI commencement and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
51989|NCT01298362|Secondary|Percentage Change in Lumbar Spine Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
51991|NCT01298362|Primary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy|"BMD was evaluated at lumbar spine (LS) and hip (HIP) with measurements taken before CT, before AI therapy and at the end of the 12 month followup period while on AI treatment. Dual Energy X-Ray Absorptiometry (DEXA scan) was used with all measurements performed with the Explorer absorptiometer produced by Hologic, Bedford, MA, USA in the same referral site in Athens, apart from two centres in other cities which used however the same absorptiometer model with identical software.~The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group."|Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with LS BMd measurements both at baseline and at 12 months of AI therapy.||percentage of change||95% Confidence Interval|Mean
51992|NCT01298323|Primary|Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.|The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.|12 months|Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.||Percentage of days|Participants|Standard Deviation|Mean
51993|NCT01298167|Primary|Visual Analog Scale (VAS)|"The Visual Analog or Analogue Scale (VAS)* is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to their feeling. It also gives the maximum opportunity for each respondent to express a personal response style.~The scale is interpreted as the greater the scale score (as the score approaches 10), the greater the cosmetic and functional outcome of the healed wound.~Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993~Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102~Hayes, M. H. S. & D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99"|3 months|Individuals' wounds were divided in half and then treated with both Cyanoacrylate and Fast Absorbing Gut Suture. Individuals were randomized as to which half of the wound (superior or inferior) would be treated by each of the methods.||units on a scale||Standard Deviation|Mean
51994|NCT01298128|Primary|Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)|abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain|patients were followed for the duration of an in-vitro fertilization cycle- 2 months|70 patients were recruited and randomized. 53 patients completed the study. 11 patients did not then undergo an ivf cycle after recruitment. 6 patients withdrew from the study after recruitment.||participants|||Number
51995|NCT01298063|Secondary|Clinical Relevant Abnormalitites for Physical Examination, Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Adverse Event, Investigator's Global Tolerability|Clinical relevant abnormalitites for physical examination, vital signs, 12-lead electrocardiogramm (ECG), clinical laboratory test (including hematology, clinical chemistry, coagulation, urinalysis), adverse event, investigator's global tolerability. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 28 days after last administration of trial medication|Treated set||participants|||Number
51996|NCT01298063|Secondary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
51997|NCT01298063|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of the analyte in plasma|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
51998|NCT01298063|Primary|Area Under Curve From 0 to Infinity (AUC0-infinity)|AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|Pharmacokinetic (PK) analysis set includes all evaluable matched subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations. Group B1 was not included in the primary analysis set for comparison.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
51999|NCT01297920|Primary|Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3|The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-Treat (ITT): All subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.||millimeters mercury (mm HG)||Standard Error|Least Squares Mean
52000|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Infinite Time [MRAUC (0- ∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0- ∞) [MRAUC (0- ∞)].|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.||Ratio||Standard Deviation|Geometric Mean
52001|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
52002|NCT01297595|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite (PF-06260182) to parent (crizotinib) molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
52003|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
52004|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
52005|NCT01297595|Secondary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
52006|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
52007|NCT01297595|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Liter||Standard Deviation|Geometric Mean
52008|NCT01297595|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the plasma. Clearance obtained after oral dose (apparent oral clearance [CL/F]) is influenced by the fraction of the dose absorbed (F).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Liter/hour (L/hr)||Standard Deviation|Geometric Mean
52009|NCT01297595|Secondary|Plasma Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
52010|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
52011|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
52012|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
52013|NCT01297595|Primary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
52026|NCT01297491|Secondary|Overall Survival (OS) Using Kaplan-Meier Estimates|OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.|Every 8 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Months||95% Confidence Interval|Median
52014|NCT01297517|Primary|Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)|At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-treat (ITT): All patients who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.||millimeters mercury (mm Hg)||Standard Error|Least Squares Mean
52015|NCT01297504|Secondary|Mean Number of Doses of Palivizumab Administered||12 months|||doses||Standard Deviation|Mean
52016|NCT01297504|Primary|Distribution of Comorbidities in Study Participants|The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.|Baseline|||percentage of participants|||Number
52017|NCT01297504|Secondary|Compliance to Prescribed Palivizumab|Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.|12 months|||Percentage of expected dose||95% Confidence Interval|Number
52018|NCT01297504|Secondary|Risk Factors for Hospitalization|Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.|Baseline and 12 months|||rate ratio||95% Confidence Interval|Number
52019|NCT01297504|Secondary|Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV||12 months|Participants with hospitalization due to LTRI and hospitalization due to LTRI and RSV.||hospitalization episodes|Participants||Number
52020|NCT01297504|Secondary|Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV|The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.|12 months|||participants|||Number
52021|NCT01297504|Primary|Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection|Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).|Baseline|||participants|||Number
52022|NCT01297491|Secondary|Duration of Response (DoR)|DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.||Days|||Number
52023|NCT01297491|Secondary|Time to Response (TTR)|TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.||Days|||Number
52024|NCT01297491|Secondary|Disease Control Rate (DCR)|"DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.~Analyses of response rates were performed based on investigators’ assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline."|Every 6 weeks up tp 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Percentage of participants|||Number
52025|NCT01297491|Secondary|Overall Response Rate (ORR) Based on Investigator Assessment|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators’ assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Percentage of participants|||Number
52039|NCT01297465|Secondary|Total Number of Stimulation Treatment Days||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||days||Standard Deviation|Mean
52027|NCT01297491|Primary|Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12|"PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a success for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate <50% at 12 weeks was observed.~No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group."|Week 12|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
52028|NCT01297465|Secondary|Heart Rate Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||beats per minute (bpm)||Standard Deviation|Mean
52029|NCT01297465|Secondary|Systolic and Diastolic Arterial Blood Pressure Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||millimeter of mercury ( mm Hg)||Standard Deviation|Mean
52030|NCT01297465|Secondary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||participants|||Number
52031|NCT01297465|Secondary|Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Early OHSS was defined as the onset of OHSS occurring within 9 days after oocyte retrieval and late OHSS was defined as the onset of OHSS occurring on or after day 10 from oocyte retrieval.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||participants|||Number
52032|NCT01297465|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."||participants|||Number
52033|NCT01297465|Secondary|Biochemical Pregnancies Rate|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of human chorionic gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Participants with beta- hCG concentration greater than 10 international units per liter (IU/L) were considered as biochemical pregnant.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. . N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."||participants|||Number
52034|NCT01297465|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment|An excessive ovarian response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An insufficient ovarian response: defined as 3 or less follicles of greater than or equal to 12 millimeter developing following at least 7 days of treatment.|S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.||participants|||Number
52035|NCT01297465|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Clinical pregnancy rate was reported as total clinical pregnancy rate, clinical pregnancy rate per cycle started and per embryo transfer [ET]).|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and had completed the primary efficacy assessment. N signifies those participants who had their ET in study treatment cycle. n signifies those participants who were evaluated for this measure in specified categories."||percentage of participants|||Number
52036|NCT01297465|Secondary|Number of Fetal Hearts With Activity|Number of fetal hearts with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||fetal hearts||Standard Deviation|Mean
52037|NCT01297465|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||fetal sacs||Standard Deviation|Mean
52038|NCT01297465|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.||percent sacs per embryo||Standard Deviation|Mean
52041|NCT01297465|Primary|Total Number of Oocytes Retrieved|The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])|Modified intention-to-treat (Mod-ITT) population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.||oocytes||Standard Deviation|Mean
52042|NCT01297348|Primary|Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls|Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.||participants|||Number
52043|NCT01297348|Primary|Incidence Rate of Idiopathic Venous Thromboembolism (VTE)|Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.||incidence rate per 100000 person-years|||Number
52044|NCT01297335|Secondary|Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection|Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth.|Before clonidine injection (Baseline), and at 1 hour after clonidine injection.|All qualified subjects were given intrathecal clonidine and were asked to rate level of sedation and sensation of dry mouth before clonidine injection (baseline) and 1 hour post injection on VAS scale.||cm||Standard Deviation|Mean
52045|NCT01297335|Secondary|Likert Scale Pain Rating|Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain.|Pre-dose and 1 hour post injection.|All subjects met inclusion and exclusionary criteria, and received intrathecal injection of clonidine. Subjects were asked to rate their baseline pain on Likert scale prior to receiving intrathecal clonidine injection, and 1 hour post intrathecal clonidine injection.||units on a scale||Standard Deviation|Mean
52046|NCT01297335|Primary|Change in Blood Pressure After Intrathecal Injection of Clonidine.|"Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours.~Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline."|Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection|All subjects met inclusion and exclusionary criteria, and was given an intrathecal injection of clonidine. They were followed for changes in blood pressure for 4 hours.||mm Hg||Standard Deviation|Mean
52047|NCT01297322|Secondary|Rate of Combined Minor Access Site Complications|"Secondary safety endpoint~Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis;~Access site-related hematoma > 6 cm;~Late access site-related bleeding (following hospital discharge);~Ipsilateral lower extremity arterial emboli;~Ipsilateral deep vein thrombosis;~Access site-related vessel laceration;~Access site wound dehiscence;~Localized access site infection treated with intramuscular or oral antibiotics;~Arteriovenous fistula not requiring treatment;~Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection;~Pseudoaneurysm not requiring treatment;~New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair;~Ipsilateral pedal pulse diminished by two grades or transiently lost."|30 days +/- 7 days|||participants|||Number
52048|NCT01297322|Secondary|Procedure Success|Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days|30 days +/- 7 days|||participants|||Number
52049|NCT01297322|Secondary|Device Success|Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression|Up to 1 day|||participants|||Number
52050|NCT01297322|Secondary|Time to Hospital Discharge (TTHD)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital|Up to 2 days|||hours||Standard Deviation|Mean
52051|NCT01297322|Secondary|Time to Discharge Eligibility (TTDE)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team|Up to 2 days|||hours||Standard Deviation|Mean
52052|NCT01297322|Secondary|Time to Ambulation (TTA)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding|Up to 1 day|||hours||Standard Deviation|Mean
52053|NCT01297322|Primary|Rate of Combined Access Site-related Major Complications|"Primary safety endpoint~Access site-related bleeding requiring transfusion;~Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft);~New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.;~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization;~New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair;~Permanent access site-related nerve injury. (> 30 days)"|30 days +/- 7 days|||participants|||Number
52054|NCT01297322|Primary|Time to Hemostasis (TTH)|Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.|Up to 1 hour|||minutes||Standard Deviation|Mean
52055|NCT01297283|Secondary|Evaluation of Factors Such as Device Rotation, Device Fixation, Device Side Facing the Skin, Position of Lead Loops in the Pocket, Use of Antiseptic Solution, Skin Type, Body Mass Index on the Quality of Leadless ECG.|"The following factors will be evaluated to investigate whether they influence the LECG quality:~device position (subcutaneous, submuscular, etc)~device rotation~device fixation~device side facing the skin~position of lead loops in the pocket~use of antibiotics in the pocket~skin type (loose, normal, firm)~body mass index (BMI)~The endpoints will be:~describe R wave amplitude values~describe proportion of patients with P wave visible on intrinsic LECG strips recorded at 1-Month FU."|30 to 120 days||||||
52056|NCT01297283|Secondary|Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.|"The intrinsic R wave amplitude and P waves visibility will be taken to evaluate the effect of posture changes and artifact-inducing maneuvers on the quality of LECG at the 1-Month Follow-Up visit (LECG vector with best combination of the highest R wave and most visible P wave).~The endpoints will be R wave amplitude and P wave visibility in different positions (meaning visible or not visible in both positions).~R wave changes and proportion of patients with stable P waves visibility at lying position versus other positions will be calculated by an independent reviewer."|30 to 120 days||||||
52057|NCT01297283|Secondary|Quality of LECG in New Devices Versus Device Replacements.|"The two following parameters will be used to compare the quality of LECG in new implants versus device replacements at PHD and 1-Month on the same LECG vector:~Intrinsic R wave amplitude~P waves visibility The LECG vector at PHD with best combination of the highest R wave and most visible P wave will be selected.~R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.~The endpoints will be:~comparison of mean R wave values at PHD and 1-month~comparison of proportion of patients with P wave visible at PHD and 1-month."|30 to 120 days||||||
52058|NCT01297283|Secondary|Evaluation of the Stability of LECG Performance Over Time.|"Two parameters will be used to evaluate LECG changes between PHD and 1-Month on the same LECG vector: intrinsic R wave amplitude and P waves visibility (selection the LECG vector at PHD with best combination of the highest R wave and most visible P wave).~R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.~The endpoints evaluated are:~mean R wave changes from PHD to 1-month~proportion of patients with stable P wave visibility at PHD and 1-Month (meaning both visits visible or both visits not visible)."|30 to 120 days||||||
52059|NCT01297283|Secondary|Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.|"The investigator will simulate loss of capture (LOC) at 1-Month Follow-Up visit by printing strips of LOC in both ventricular leads, LOC in LV lead only, LOC in RV lead only, no LOC. One strip randomly selected among them by the study manager will be submitted to an independent reviewer. With help of the PHD template LECG strips (intrinsic, RV paced, LV paced, BiV paced) of this patient, he/she will determine which lead is capturing.~The endpoint is the proportion of correct classifications of ventricular capture done by then independent reviewer of LECG."|30 to 120 days|Proportion of Patients Correctly Classified||proportion||95% Confidence Interval|Number
52060|NCT01297283|Primary|Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.|During CRT-P standard follow-up, ECG is used to determine atrial, left and right ventricular pacing thresholds. As primary endpoint, we will consider the proportion of patients for which for all leads LECG provides pacing threshold values that are clinically equivalent to those obtained with PECG taken as reference. The analysis will be performed on data collected at the 1-Month Follow-Up visit when the device pocket healing process is completed. Clinical equivalence will be defined as the LECG threshold values being no more than 0.5 volts different from the PECG threshold values.|30 to 120 days|||proportion||95% Confidence Interval|Number
52061|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52062|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52063|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52064|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52065|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52066|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52067|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52068|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||participants|||Number
52069|NCT01297270|Secondary|Early Treatment Success (ETS)|Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|Week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants|||Number
52070|NCT01297270|Secondary|Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|"Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.~Hepatitis C virus Ribonucleic acid (HCV RNA)"|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication and had SVR data at week 24.||percentage of participants||95% Confidence Interval|Number
52071|NCT01297270|Primary|Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
52072|NCT01297257|Secondary|In-hospital MACE (Major Adverse Cardiac Event)||stent implantation until hospital discharge (average 1-3 days)|||Participants|||Number
52073|NCT01297257|Primary|Delivery Success|The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.|stent implantation until hospital discharge (average 1-3 days)|||stents|Participants||Number
52074|NCT01297062|Secondary|Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3|The plasma exenatide concentration at steady state was descriptively summarized by geometric mean, standard error, and its effect on placebo-adjusted change from baseline in QTcP was assessed.|Baseline, Day 1, 2, and 3|Evaluable Population. No imputation for missing value was used. Day 1, 2, and 3 exenatide concentration < LLOQ was set to missing.||pg/mL||Standard Error|Geometric Mean
52075|NCT01297062|Secondary|Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with increase of QTcP interval from baseline >30 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Baseline, Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.||particpants|||Number
52076|NCT01297062|Secondary|Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with QTcP > 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.||participants|||Number
52077|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
52078|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
52079|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
52080|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 3|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
52081|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.||msec||90% Confidence Interval|Least Squares Mean
52082|NCT01297062|Primary|Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.|Baseline, Day 1|Evaluable Population included all ITT subjects who completed all ECG assessment periods and have valid ECG measurements and no vomiting in any ECG data extraction window. No missing value was imputed.||msec||90% Confidence Interval|Least Squares Mean
52083|NCT01296841|Secondary|Clinic Appointment Wait Time|The investigators recorded clinic appointment wait time duration in minutes|Clinic Visit|||minutes||Standard Deviation|Mean
52084|NCT01296841|Secondary|Clinic Appointment Duration|The investigators recorded appointment duration in minutes.|Clinic Visit|Pilot.||Minutes||Standard Deviation|Mean
52085|NCT01296841|Primary|Patient Clinical Experience|We used a validated Ware Specific Visit Questionnaire to assess patients’ satisfaction with their clinic-visit encounter. This is a 14-item questionnaire on doctor–patient interaction including factors such as attention to complaints, technical skills, and personal manner (courtesy,and ease of appointment scheduling and is based on a five-point Likert scale (1 excellent to 5 poor). Patients completed the questionnaire at the time of the visit. The 14 item scores were individually scored and then averaged to provide the final overall value.|Clinic Visit|per protocol||units on a scale||Standard Deviation|Mean
52086|NCT01296815|Secondary|Safety|Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.|12 months||||||
52087|NCT01296815|Primary|Number of Participants With Complete Response|Complete response will be assessed according to RECIST criteria|12 months|||participants|||Number
52088|NCT01296763|Secondary|Number of Years From Cycle 1, Day 1 On-Study to Date of Death|The overall survival of subjects with locally advanced and/or metastatic pancreatic cancer treated with Irinotecan, Cisplatin, Olaparib, with escalation to the addition of Mitomycin-C. Survival from cycle 1, day 1 on-study to date of death was assessed.|5 years|||years (survival) from C1D1 to death||Full Range|Mean
52089|NCT01296763|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)|"1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1:~Thrombocytopenia with platelets <25,000 x106/l > 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation.~Delay of >2 weeks for next scheduled IC/ICM for reasons of toxicity."|2 years|Number of subjects who experienced a dose limiting toxicity, as defined in the protocol.||participants|||Number
52090|NCT01296698|Secondary|Participant Score for Product Convenience|Participants are asked to rate how convenient the product is to use, on a scale of 1-5, where 1=not at all convenient and 5=extremely convenient.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
52091|NCT01296698|Secondary|Participant Score for Change in Perception|Participants are asked to rate how their opinion has changed since the first time they used it, on a score of 1-5, where 1=I like it much less now and 5=I like it much more now.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
52092|NCT01296698|Secondary|Participant Score for Speed of Action|Participants are asked to rate the product for speed of action, on a scale of 1-9, where 1=extremely slow and 9=extremely fast.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
52093|NCT01296698|Secondary|Participant Score for Product Effectiveness in Dealing With Cravings|Participants are asked to rate the product in its effectiveness for dealing with cravings, on a scale of 1-5, where 1=not at all effective, and 5=extremely effective.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
52094|NCT01296698|Secondary|Participant Score for General Perception of the Product|Participants are asked to rate their general perception of the investigational product on a scale of 1-10, where 1=very poor and 10=excellent.|through Week 12|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Units on a scale||Standard Deviation|Mean
52095|NCT01296698|Secondary|Highest Rating of Increased Appetite on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Increased Appetite on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
52096|NCT01296698|Secondary|Highest Rating of Insomnia on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Insomnia on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
52097|NCT01296698|Secondary|Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Dysphoric or Depressed Mood on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
52098|NCT01296698|Secondary|Highest Rating of Anxiety on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Anxiety on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
52099|NCT01296698|Secondary|Highest Rating of Difficulty Concentrating on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Difficulty Concentrating on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and completed the questionnaire.||Percentage of Participants|||Number
52100|NCT01296698|Secondary|Highest Rating of Restlessness on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Restlessness on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
52101|NCT01296698|Secondary|Highest Rating of Irritability/Frustration/Anger on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Irritability/Frustration/Anger on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
52102|NCT01296698|Secondary|Highest Rating of Desire/Urge to Smoke on a Categorical Scale|Participants are asked if during the last 24 hours they experienced the Desire/Urge to Smoke on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.||Percentage of Participants|||Number
52103|NCT01296698|Secondary|Percentage of Participants With High Usage|Percentage of participants who used more than four doses in any one-hour period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.||Percentage of Participants|||Number
52104|NCT01296698|Secondary|Percentage of Participants With High Dosage|Percentage of participants who used more than 64 doses in any one-day period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.||Percentage of Participants|||Number
52105|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 6|Analysis was limited to data collected from participants at Week 6. Analysis of data for the remainder of the study weeks was not possible because the trial terminated prematurely due to a technical issue (randomization error).||Daily Doses||Standard Deviation|Mean
52106|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 5|Analysis was limited to data collected from participants at Week 5.||Daily Doses||Standard Deviation|Mean
52107|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 4|Analysis was limited to data collected from participants at Week 4.||Daily Doses||Standard Deviation|Mean
52108|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 3|Analysis was limited to data collected from participants at Week 3.||Daily Doses||Standard Deviation|Mean
52109|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 2|Analysis was limited to data collected from participants at Week 2.||Daily Doses||Standard Deviation|Mean
52110|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 1|Analysis was limited to data collected from participants at Week 1.||Daily Doses||Standard Deviation|Mean
52111|NCT01296698|Secondary|Number of Participants With 7-day Point Prevalence Abstinence|Number of participants with carbon monoxide (CO)-verified self-reported 7-day point prevalence abstinence from smoking at Weeks 2, 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error).||Participants|||Number
52112|NCT01296698|Secondary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self report of continuous abstinence from smoking from Week 2 to Weeks 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Participants|||Number
52113|NCT01296698|Primary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.|through Week 6|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.||Participants|||Number
52114|NCT01296646|Secondary|Percent Days Abstinent|Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.|12 weeks|||percentage of days||Standard Deviation|Mean
52115|NCT01296646|Primary|Percent Heavy Drinking Days|Percentage of heavy drinking days as derived from the Timeline Follow-back (TLFB) for the entire medication period. A heavy drinking day is defined as 5 or more standard drinks for a man and 4 or more standard drinks for a woman. A standard drink is 12-14 grams of ethanol or the amount contained in a 12 oz beer, 5 oz of wine or 1 1/2 oz of hard liquor.|12 weeks|||percentage of days||Standard Deviation|Mean
52116|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <6.5%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||percentage of participants|||Number
52117|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <7.0%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||percentage of participants|||Number
52118|NCT01296412|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline at Week 26 is defined as Week 26 minus Week 0.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
52119|NCT01296412|Primary|Change From Baseline in Hemoglobin A1c (A1C)|A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.||percent||95% Confidence Interval|Least Squares Mean
52120|NCT01296360|Secondary|Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration.||7 days||||||
52121|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month||||||
52122|NCT01296360|Secondary|Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month||||||
52123|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations.||36 months||||||
52124|NCT01296360|Secondary|Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and||36 months||||||
52125|NCT01296360|Secondary|GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination||36 months||||||
52126|NCT01296360|Secondary|GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose||1 month||||||
52127|NCT01296360|Secondary|Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose||1 month||||||
52128|NCT01296360|Primary|SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose||1 month post booster|Intent-to-treat Population: primary analysis population for the immunogenicity analyses; defined as all subjects randomized||percentage of subjects||95% Confidence Interval|Number
52129|NCT01296152|Secondary|Regulatory T Cells (Tregs) at Baseline, Week 4 and Week 12 Using Flow Cytometry in Freshly Thawed PBMCs.|This evaluates the effect of MPA on Tregs at baseline (Day 0), week 4 and week 12 using flow cytometry in freshly thawed PBMCs. A summary of CD4+ and cluster of differentiation 8 (CD8+) anchored T-cell subsets by study week, in percent that express the marker of interest, is presented here together to provide all results pertaining to this objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 21 participants with available data were analyzed.||Percent CD4/CD8 cells expressing marker||Inter-Quartile Range|Median
52130|NCT01296152|Secondary|CMI to HIV and the Common Opportunistic Agent VZV Using the Lymphocyte Proliferation Assay (LPA).|This evaluates the effect of MPA on CMI to HIV and VZV. This outcome was measured at Baseline Before DMPA (Day 0) and After DMPA (Weeks 4 and 12) using the Lymphocyte Proliferation Assay (LPA). The data table shows a summary of LPA assay results by study week with stimuli HIV and VZV. Proliferation results are reported as a stimulation index (SI) which represents the ratio of the stimulated counts per minute to unstimulated control counts per minute.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.||SI Ratio||Inter-Quartile Range|Median
52131|NCT01296152|Secondary|Cell Mediated Immunity (CMI) to HIV and the Common Opportunistic Agent Varicella-zoster Virus (VZV) Using the Enzyme-linked Immunospot (ELISPOT) Assay.|This evaluates the effect of MPA on CMI to HIV and VZV at baseline before DMPA (day 0) and after DMPA (weeks 4 and 12) . Cytokines are interferon-gamma (IFN-gamma) and interleukin 2 (IL-2), and Stimuli are HIV and VZV. Summary of adjusted ELISPOT assay results is in spot forming cells (SFC)/10^6 peripheral blood mononuclear cells (PBMC) by study weeks 0, 4 and 12. The outcome measures of IFN-gamma and IL-2 measured for HIV and VZV are presented here together to provide all results pertaining to the same objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.||SFC/10^6 PBMC||Inter-Quartile Range|Median
52132|NCT01296152|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL.|This evaluates the short-term impact of MPA on virologic suppression in participants taking LPV/r who have received a dose of DMPA by measuring percentage of participants with HIV-1 RNA levels <400 copies/mL at day 0 (prior to DMPA injection) and at weeks 2, 4, 8 and 12 (after DMPA injection). An FDA-approved HIV-1 RNA assay with a lower limit of detection of 75 copies/mL or less was required and the same HIV-1 RNA assay was required to be performed for each participant across all study visits. The Roche COBAS AmpliPrep/TaqMan HIV-1 and Abbott RealTime HIV-1 tests were used.|Day 0, Weeks 2, 4, 8, and 12|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the HIV-1 RNA draw (see N for each week in table below).||Percent of Participants|||Number
52133|NCT01296152|Secondary|Percentage of Participants With Menstrual Irregularities of Grade 1 and Higher Deemed Possibly, Probably or Definitely Related to Study Treatment.|This evaluates toxicity and safety of concomitant medication of DMPA and LPV/r, focusing specifically on the adverse event (AE) menstrual irregularities with abnormal vaginal bleeding. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study's co-chairs.|From day 0 to week 12|This analysis focuses on the 24 participants eligible for the PK analyses.||Percent of Participants|||Number
52134|NCT01296152|Secondary|RTV PK Parameter T1/2.|This evaluates the effect of MPA on the PK parameter T1/2 of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC. For one participant at day 0, T1/2 results were not estimated.||hour||Full Range|Median
52519|NCT01291173|Secondary|4-Week Binge Response|Subjects are free from binge episodes for 4 weeks.|Last 28 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Participants|||Number
52135|NCT01296152|Secondary|RTV PK Parameter CL/F.|This evaluates the effect of MPA on the PK parameter CL/F of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||L/hour||Full Range|Median
52136|NCT01296152|Secondary|RTV PK Parameter Tmax.|This evaluates the effect of MPA on the PK parameter Tmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||hour||Full Range|Median
52137|NCT01296152|Secondary|RTV PK Parameter Cmax.|This evaluates the effect of MPA on the PK parameter Cmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
52138|NCT01296152|Secondary|RTV PK Parameter Cmin.|This evaluates the effect of MPA on the PK parameter Cmin of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
52139|NCT01296152|Secondary|Ritonavir (RTV) PK Parameter AUC0-12h.|This evaluates the effect of MPA on the PK parameter AUC0-12h of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. Blood samples were drawn for RTV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.||ng*h/mL||Full Range|Median
52140|NCT01296152|Secondary|LPV PK Parameter T1/2.|This evaluates the effect of MPA on the secondary LPV PK parameter T1/2 obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||hour||Full Range|Median
52141|NCT01296152|Secondary|LPV PK Parameter CL/F.|This evaluates the effect of MPA on the secondary LPV PK parameter CL/F obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||L/hour||Full Range|Median
52142|NCT01296152|Secondary|LPV PK Parameter Tmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Tmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||hour||Full Range|Median
52143|NCT01296152|Secondary|LPV PK Parameter Cmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
52144|NCT01296152|Secondary|LPV PK Parameter Cmin.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmin obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.||ng/mL||Full Range|Median
52145|NCT01296152|Secondary|MPA PK Parameter Half-Life (T1/2) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter T1/2 based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC. A minimum of three observations in the elimination phase was required to determine T1/2 and therefore results are presented for 22 participants.||week||Full Range|Median
52146|NCT01296152|Secondary|MPA PK Parameter Clearance (CL/F) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter CL/F based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||L/week||Full Range|Median
52147|NCT01296152|Secondary|MPA PK Parameter Time to Cmax (Tmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Tmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||week||Full Range|Median
52148|NCT01296152|Secondary|MPA PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||ng/mL||Full Range|Median
52149|NCT01296152|Secondary|MPA PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmin based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.||ng/mL||Full Range|Median
52150|NCT01296152|Secondary|Percentage of Participants With Progesterone Levels Less Than the Lower Limit of Quantification (LLQ).|This evaluates the suppression of ovulation due to the potential PK interaction between DMPA and LPV/r. The LLQ of progesterone is 0.5ng/mL. The threshold for suppression of ovulation is 5ng/mL.|0, 2, 4, 6, 8, 10, and 12 weeks|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the progesterone draw (see N for each week in table below).||Percent of Participants|||Number
52537|NCT01290952|Secondary|Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one of more of the following:~Post-operative Atrial Fibrillation~IAPB (Intra-Aortic Balloon Pump) insertion and low cardiac output syndrome~Ventilation > 24h~Sternal wound infection or dehiscence"|30 days|||participants|||Number
52151|NCT01296152|Primary|AUC0-12hour for LPV at Baseline (Day 0) Before DMPA Administration and at Week 4 (Four Weeks After DMPA Administration)|This evaluates the effect of DMPA on LPV PK parameter AUC by comparing PK AUCs of LPV from 0 to 12 hours obtained at study Day 0 (before DMPA was administered) with PK AUCs of LPV from 0 to 12 hours at study Week 4 (4 weeks after DMPA was administered). Blood samples were drawn for LPV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|All participants eligible for the first primary PK outcome measure (MPA AUC0-12weeks) were included in this second primary outcome measure looking at LPV AUC0-12hours at Day 0 and week 4.||ng*h/mL||Full Range|Median
52152|NCT01296152|Primary|Medroxyprogesterone Acetate (MPA) Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-12weeks)|This evaluates the effect of lopinavir/ritonavir (LPV/r) on pharmacokinetic parameter AUC of MPA by looking at the MPA AUC from day 0 to week 12. AUC0-12weeks was calculated using single MPA concentrations sampled immediately prior to DMPA administration on day 0, and at 2, 4, 6, 8, 10 and 12 weeks after administration of the single DMPA dose.|Day 0, Weeks 2, 4, 6, 8, 10 and 12|One participant was excluded from all PK analyses for taking a prohibited medication with potential to interfere with PK assessments. For another participant who missed week 10 and 12 visits, a modelling approach was used to estimate the week 12 MPA level.||ng*wk/mL||Full Range|Median
52153|NCT01296035|Secondary|Adverse Events, Measured by Active Version of the NCI Common Toxicity Criteria|Adverse events (AEs) will be recorded during the duration of the trial, whether or not the events are considered related to medication. All AEs considered to be related to trial therapy will be followed for resolution, including into the post-treatment period.|Every 4 weeks while on-study, up to 24 weeks|Please see results section. In short, there were 3 serious adverse events (1 thromboembolic, 1 hypomagnesemia, 1 bowel obstruction). Additional adverse events included (in decreasing order) rash, fatigue, anemia, edema, thrombocytopenia, abdominal pain, epistaxis, hypocalcemia, and calciphylaxis||participants|Participants||Number
52154|NCT01296035|Primary|Overall Response Rate, Measured by RECIST Criteria|Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.|Every 8 weeks while on-study|Due to the small number of participants, data were not collected as planned|||||
52155|NCT01295905|Secondary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.||Units on a scale||Standard Deviation|Mean
52156|NCT01295905|Secondary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.||Units on a scale||Standard Deviation|Mean
52157|NCT01295905|Secondary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.||Units on a scale||Standard Deviation|Mean
52158|NCT01295905|Primary|Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity|Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.|3 months of wear, lenses replaced daily|Per protocol.||eyes|Participants||Number
52159|NCT01295879|Secondary|Recurrence of Kidney Stones||8 weeks|||# of stone recurrences|||Number
52160|NCT01295879|Secondary|Change in 24 Hour Urine Supersaturation of Calcium Oxalate|Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones|8 weeks|||(unitless)||Standard Deviation|Mean
52161|NCT01295879|Primary|Change in 24 Hour Urine Calcium|Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones|8 weeks|||mg/day||Standard Deviation|Mean
52162|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At 6 months|||participants|||Number
52163|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At 6 months|||participants|||Number
52164|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At enrollment|||participants|||Number
52165|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At enrollment|||participants|||Number
52166|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|At 6 months|||number of vectors|Participants||Number
52167|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)|||number of vectors|Participants||Number
52168|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|6 months post-implant|||volts||Standard Deviation|Mean
52169|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)|||volts||Standard Deviation|Mean
52170|NCT01295840|Secondary|Cardiac Output (CO) With Different Configurations at Enrollment|Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.|Enrollment visit (in the seven days after implantation of the device)|||L/min||Standard Deviation|Mean
52171|NCT01295840|Secondary|Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors|"In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors.~The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC."|At enrollment|||percentage of difference of CO||Standard Deviation|Mean
52172|NCT01295840|Primary|Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.||Enrollment visit (in the seven days after implantation of the device)|||participants|||Number
52173|NCT01295814|Secondary|Global Response Assessment (GRA)|"Percent(%) of patients who reported 50% or greater overall improvement in their condition.~Score on a scale range (improvement 0%-100%)"|Measured at12 Weeks|||percentage of participants|||Number
52174|NCT01295814|Secondary|Pelvic Pain Urgency/Frequency (PUF) Score|Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)|Baseline12 Weeks|||units on a scale||Standard Deviation|Mean
52175|NCT01295814|Secondary|Interstitial Cystitis Problem Index (ICPI)|Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)|Baseline/12 Weeks|||units on a scale||Standard Deviation|Mean
52176|NCT01295814|Secondary|Interstitial Cystitis Symptom Index (ICSI)|Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)|Baseline/ 12 weeks|||units on a scale||Standard Deviation|Mean
52177|NCT01295814|Primary|O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score|Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)|Baseline/12 Weeks|||units on a scale||Standard Deviation|Mean
52178|NCT01295281|Secondary|Perception of Discomfort Due to Other Causes|To compare subject’s tolerability with regards to perceived discomfort due to other causes, when using two different urinary catheters 2.0. Frequency of discomfort due to other causes (yes/ no) will be assessed in patient questionnaire. The frequency of discomfort due to other causes will be compared between the treatments. Discomfort due to other causes will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).|At 7 and 14 days after randomization, respectively||||||
52179|NCT01295281|Secondary|Perception of Resistance|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52180|NCT01295281|Secondary|Perception of Smoothness|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52181|NCT01295281|Secondary|Perception of Slipperiness|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52182|NCT01295281|Secondary|Perception of Catheter Tip|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52183|NCT01295281|Secondary|Perception of Catheter Adherence|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52184|NCT01295281|Secondary|Perception of Catheter Eyes|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52185|NCT01295281|Secondary|Perception of Stiffness/ Rigidity|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52186|NCT01295281|Secondary|Perception of “Other Discomfort”|To compare subject’s tolerability with regards to perceived “other discomfort”, when using two different urinary catheters; PVC vs. POBE 2.0. Frequency of “other discomfort” (yes/ no) will be assessed in patient questionnaire. The frequency of “other discomfort” will be compared between the treatments. “Other discomfort” will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).|At 7 and 14 days after randomization, respectively||||||
52187|NCT01295281|Secondary|Presence of Bleeding|To compare subject’s tolerability with regards to presence of bleeding, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52188|NCT01295281|Secondary|Perception of Burning Sensation|To compare subject’s tolerability with regards to perceived burning sensation, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52189|NCT01295281|Secondary|Perception of Pain|To compare subject’s tolerability with regards to perceived pain, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively||||||
52190|NCT01295281|Primary|Number of Participants With Discomfort|The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.|At 7 and 14 days after randomization, respectively|"Since the study is cross-over, all (104) subjects evaluated both LoFric POBE 2.0 and LoFric PVC. To be able to group and describe the results the Arm/Group Titles are renamed in this section to LoFric POBE 2.0 and LoFric PVC respectively. Each Arm/Group describing the outcome for all 104 subjects (ITT analysis set)."||participants|||Number
52191|NCT01294917|Secondary|Dryness|This will be assessed by the tear break-up time on the lens surface, measured in seconds.|4 weeks||||||
52192|NCT01294917|Secondary|Subjective Lens Wearing Comfort|This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.|4 weeks||||||
52193|NCT01294917|Primary|Corneal Staining|Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.|4 weeks|Only subjects that completed all three arms were included in analysis.||units on a scale||Standard Deviation|Mean
52194|NCT01294800|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 12 Weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug||Participants|||Number
52195|NCT01294800|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 14 weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug||Participants|||Number
52196|NCT01294800|Secondary|Change From Baseline in Mean “On” Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|FAS population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.||Hours/Day||Standard Deviation|Mean
52208|NCT01294787|Secondary|Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
52197|NCT01294800|Secondary|Percentage of Participants With ≥30% Reduction in “Off” Time at Week 12|The proportion of responders (≥30% Reduction in “Off” Time at Week 12) was analyzed using a generalized linear mixed model with baseline mean OFF time (hours/day) as a covariate and treatment-by-time interaction as a fixed effect, and an unstructured covariance matrix was used to model the correlation among repeated measurements. Responder rates for each treatment arm are presented as are differences from placebo with 95% confidence interval.|Up to 12 Weeks|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.||Percentage of participants|||Number
52198|NCT01294800|Primary|Change From Baseline in Mean “Off” Time (Hours Per Day) at Week 12|"The on state is defined as the period of time during which a participant's symptoms of PD improve or disappear following treatment with levodopa (L-dopa) or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.||Hours/Day||Standard Deviation|Mean
52199|NCT01294787|Secondary|Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo|The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).|Day 1|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Seconds||Standard Error|Least Squares Mean
52200|NCT01294787|Secondary|Exercise Endurance Comparison Between QVA149 and Tiotropium Groups|Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Seconds||Standard Error|Least Squares Mean
52201|NCT01294787|Secondary|Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Error|Least Squares Mean
52202|NCT01294787|Secondary|Exertional Dyspnea Comparison Between QVA149 and Placebo Groups|"The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement."|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Error|Least Squares Mean
52203|NCT01294787|Secondary|Spirometry After Three Weeks of Treatment on Patients Not Exercising|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
52204|NCT01294787|Secondary|Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
52205|NCT01294787|Secondary|Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Kilo Pascal per second||Standard Error|Least Squares Mean
52206|NCT01294787|Secondary|Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
52207|NCT01294787|Secondary|Pulmonary Function Test Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
52209|NCT01294787|Secondary|Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
52210|NCT01294787|Secondary|Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters||Standard Error|Least Squares Mean
52211|NCT01294787|Primary|Exercise Tolerance Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Seconds||Standard Error|Least Squares Mean
52212|NCT01294748|Secondary|Stent Thrombosis (Definite/Probable)|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|9-months|||percentage of patients|||Number
52213|NCT01294748|Secondary|Target Lesion Failure (TLF)|Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization|9-months|||percentage of patients|||Number
52214|NCT01294748|Secondary|Target Vessel Failure (TVF)|Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization|9-months|||percentage of patients|||Number
52215|NCT01294748|Secondary|Clinically-driven Target Lesion Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.|9-months|||percentage of patients|||Number
52216|NCT01294748|Secondary|Total Myocardial Infarct (MI)|"Q-wave MI (QWMI): requires one of the following criteria: development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x ULN elevation of CK levels; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.~Non-Q-wave MI (NQWMI):the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels (≥3 times ULN) in the absence of new pathologic Q waves.~Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation >3xULN within 48 hours post –PCI, with a normal CK-MB at baseline."|9-months|||percentage of patients|||Number
52217|NCT01294748|Secondary|Total Mortality||9-months|||percentage of patients|||Number
52218|NCT01294748|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, MI or repeat revascularization of the target lesion pre-hospital discharge.|8 hours|||percentage of participants|||Number
52219|NCT01294748|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.|8 hours|||percentage of participants|||Number
52220|NCT01294748|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.|8 hours|||percentage of participants|||Number
52221|NCT01294748|Primary|Major Adverse Cardiac Events (MACE)|Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.|9 months|||percentage of participants|||Number
52222|NCT01294748|Primary|In-Stent Late Lumen Loss|Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up|9 months|||mm||Standard Deviation|Mean
52223|NCT01294709|Secondary|Time to 1 mm ST Segment Depression|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The ECG was reviewed and the time to the first ST segment depression of 1 mm was recorded.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of time to 1 mm ST segment depression available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.||seconds||95% Confidence Interval|Least Squares Mean
52224|NCT01294709|Secondary|ST Segment Depression at Peak Exercise|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The time of peak exercise was considered the time at which the participant reached at least one of the criteria for stopping the treadmill test (evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia). The ECG for that timepoint (time of peak exercise) was evaluated and the amount of ST segment depression was determined.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of ST segment depression at peak exercise available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.||mm||95% Confidence Interval|Least Squares Mean
52289|NCT01294436|Primary|Mean Change in Aspartate Aminotransferase (AST)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||U/L||Standard Error|Mean
52225|NCT01294709|Primary|Total Exercise Duration on the Treadmill Test|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s electrocardiogram (ECG), symptoms, and arm blood pressure were continuously monitored. Regardless of whether the participant believed he or she could continue, the test was discontinued upon evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable treadmill exercise duration data available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.||Seconds||95% Confidence Interval|Least Squares Mean
52226|NCT01294709|Primary|Number of Participants With Laboratory Adverse Events|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.||Participants|||Number
52227|NCT01294709|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.||Participants|||Number
52228|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 12|The population consisted of all participants for which WOMAC VA 3.0 data was available at Month 12.||Percentage of Participants|||Number
52229|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 9|The population consistated of all participants for which WOMAC VA 3.0 data were available at Month 9.||Percentage of Participants|||Number
52230|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 6|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 6.||Percentage of Participants|||Number
52231|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 3|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 3.||Percentage of Participants|||Number
52290|NCT01294436|Primary|Mean Change in Alanine Aminotransferase (ALT)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||U/L||Standard Error|Mean
52232|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1|Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 1|The population consisted of all participants for which a WOMAC VA 3.0 measurement was available at Month 1.||Percentage of Participants|||Number
52233|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Baseline (Day 1)|The population consisted of all participants for which WOMAC VA 3.0 data for joint stiffness and limiation in physical function were available at Baseline.||Percentage of Participants|||Number
52234|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Month 12|The population consisted of all participants for which a BPI value was avaialble at Month 12.||Percentage of Participants|||Number
52235|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Baseline (Day 1)|The population consisted of all participants for which a BPI value was available at baseline.||Percentage of Participants|||Number
52236|NCT01294683|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who were discontinued from the study due to an AE were recorded.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
52237|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
52238|NCT01294683|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
52239|NCT01294683|Secondary|Percentage of Participants With New Onset of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an AE related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
52240|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
52241|NCT01294683|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
52242|NCT01294683|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
52243|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
52244|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
52245|NCT01294683|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) and throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|Up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.||Percentage of Participants|||Number
52246|NCT01294683|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.~Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
52291|NCT01294436|Primary|Mean Change in Hematocrit|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||Percent||Standard Error|Mean
52728|NCT01289548|Secondary|Urine Concentration of RBP Postoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.||mg/L||Inter-Quartile Range|Median
52247|NCT01294683|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.~Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.|||||
52248|NCT01294644|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
52249|NCT01294644|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
52250|NCT01294644|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:~How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
52251|NCT01294644|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||01/2016||||
52252|NCT01294644|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||percentage of participants|||Number
52253|NCT01294644|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||mm||Standard Deviation|Mean
52254|NCT01294644|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
52255|NCT01294644|Secondary|Change From Baseline in CR-SMFRS Score|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data||units on a scale||Standard Deviation|Mean
52256|NCT01294644|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.~The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
52257|NCT01294644|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data||percentage of participants|||Number
52258|NCT01294644|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population which included all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.||percentage of participants|||Number
52292|NCT01294436|Primary|Proportion of Participants With At Least One Episode of Hypoglycemia|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia|Long-term treatment up to 52 weeks|Safety Analysis Set||Percentage of participants|||Number
52538|NCT01290952|Primary|Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one or more of the following:~Operative Mortality~Myocardial Infarction~Postoperative neurological complications~Renal failure~ARDS (Acute Respiratory Distress Syndrome)~Bleeding"|30 days|||participants|||Number
52259|NCT01294592|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization|A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of >=5%) and SAEs.|Up to 2 years|ITT Population||Participants|||Number
52260|NCT01294592|Secondary|Exposure to Study Drug|Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.|Up to 2 years|Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date||days||Standard Deviation|Mean
52261|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: Would you ask your doctor for the treatment you received in this study? There were three possible responses, including: Yes, No, and Not sure. Response categories included Yes and No or Not Sure, created by grouping together No and Not sure. The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Participants|||Number
52262|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: Overall, how satisfied are you with the treatment and its effect on your urinary problems? There were seven possible responses, including: very satisfied, satisfied, somewhat satisfied, neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied. Response categories were created by grouping together very satisfied, satisfied, and somewhat satisfied responses into the category of Any Satisfaction (AS), and separately grouping neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied responses into the category of Neutral or Any Dissatisfaction (N/AD). The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Participants|||Number
52263|NCT01294592|Secondary|Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries|BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate [TURP], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.|Up to Month 24|ITT Population||Participants|||Number
52264|NCT01294592|Secondary|Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH|"CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS >=3 points from Baseline [Visit 2]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components (Tied for first component), and the number of participants with multiple first-occurring components were summarized by treatment group."|Up to Month 24|ITT Population||Participants|||Number
52265|NCT01294592|Secondary|Number of Events of Clinical Progression (CP) of BPH|The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS >=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.|Up to 2 years|ITT Population. Only those participants at risk for CP at the specified visit were analyzed.||Events|||Number
52293|NCT01294436|Primary|Proportion of Participants With Serious Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set||Percentage of participants|||Number
52539|NCT01290913|Secondary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour.|To tolerate refers to the ability of the patient to ingest the final challenge of 4000mg peanut flour, with either no or mild symptoms.|after 7-8 wks of desensitization|||participants|||Number
52266|NCT01294592|Secondary|Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|Each participant was asked the following question “If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?”. This response was rated from 0 (“delighted”) to 6 (“terrible”). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Scores on a scale||Standard Error|Least Squares Mean
52267|NCT01294592|Secondary|Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Scores on a scale||Standard Error|Least Squares Mean
52268|NCT01294592|Secondary|Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: >=1 point through >=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: >0 percent, >=10 percent, >=20 percent, >=25 percent, >=30 percent, >=40 percent, and >=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: >=2 points, >=3 points, and percent change >=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.||Participants|||Number
52269|NCT01294592|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach|"The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates delighted and 6 indicates terrible. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.||Scores on a scale||Standard Error|Least Squares Mean
52270|NCT01294553|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion.|41.4 weeks|ITT Population||participants|||Number
52271|NCT01294553|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|41.4 weeks|ITT Population||participants|||Number
52272|NCT01294553|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|41.4 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments||participants|||Number
52273|NCT01294514|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation|The Covidien Nellcor Respiration Rate Software shall calculate respiration rate as mean error of +/- standard deviation.|Overall average|One participant was excluded from the data analysis based on cardiac arrhythmia||Breaths Per Minute (BrPM)||Standard Deviation|Mean
52624|NCT01290614|Secondary|Number of Participants With PTH Measurement During the Study Period|The primary process outcome was measurement of PTH during the study period.|one year|||participants|||Number
52274|NCT01294514|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.~The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average of 30 minute periods|One participant was excluded from the data analysis based on cardiac arrhythmia||Breaths Per Minute (BrPM)|||Number
52275|NCT01294514|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.|Participants were monitorerd on average of 30 minute period|One participant was excluded from the analysis based on cardiac arrhythmia||Breaths Per Minute (BrPM)||Standard Deviation|Mean
52276|NCT01294462|Secondary|Composite of All-cause Mortality, MI or Stroke|Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data||Percent probability|||Number
52277|NCT01294462|Secondary|Major and Minor Bleeding|Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data||Percent probability|||Number
52278|NCT01294462|Primary|Major Adverse Cardiac Events (MACE)|Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data||Percent probability|||Number
52279|NCT01294462|Primary|Major Bleeding|Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data||Percent probability|||Number
52280|NCT01294449|Primary|All-Cause Mortality|Outcome measured for total population. Not broken down by indication received.|5 years|||participants|||Number
52281|NCT01294436|Other Pre-specified|Mean Change in Body Weight|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value||kg||95% Confidence Interval|Mean
52282|NCT01294436|Other Pre-specified|Mean Change in HbA1c Levels|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value||Percent||95% Confidence Interval|Mean
52283|NCT01294436|Primary|Mean Change in Seated Systolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mmHg||Standard Deviation|Mean
52284|NCT01294436|Primary|Mean Change in Seated Diastolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mmHg||Standard Deviation|Mean
52285|NCT01294436|Primary|Mean Change in Seated Heart Rate|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||beats per minute (bpm)||Standard Deviation|Mean
52286|NCT01294436|Primary|Mean Change in Serum Uric Acid|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mg/dL||Standard Error|Mean
52287|NCT01294436|Primary|Mean Change in Magnesium|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mEq/L||Standard Error|Mean
52288|NCT01294436|Primary|Mean Change in Blood Urea Nitrogen (BUN)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values||mg/dL||Standard Error|Mean
52625|NCT01290614|Primary|Systolic Blood Pressure (SBP)|Average SBP for those with a baseline BP > 130/80|one year|Baseline blood pressure >130/80 mmHg||mmHg||Standard Deviation|Mean
52294|NCT01294436|Primary|Proportion of Participants With Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set||Percentage of participants|||Number
52295|NCT01294423|Secondary|Adjusted Mean Change in Body Weight|To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
52296|NCT01294423|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
52297|NCT01294423|Primary|Adjusted Mean Change in HbA1c Levels|To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
52298|NCT01294384|Secondary|Change From Baseline in Schirmer Test|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||mm||Standard Deviation|Mean
52299|NCT01294384|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Score on a scale||Standard Deviation|Mean
52300|NCT01294384|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Score on a scale||Standard Deviation|Mean
52301|NCT01294384|Secondary|Change From Baseline in Tear Break-Up Time (TBUT)|TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Seconds||Standard Deviation|Mean
52302|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Percentage of participants|||Number
52303|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Percentage of participants|||Number
52304|NCT01294384|Secondary|Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness|The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||millimeters||Standard Deviation|Mean
52305|NCT01294384|Primary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.||Score on a scale||Standard Deviation|Mean
52306|NCT01294371|Secondary|Participants With Estrogen Deficiency Symptoms|"Estrogen deficiency symptoms include:~hot flashes,~headaches,~palpitations at rest,~insomnia,~fluctuation of mood."|6 months|Full Analysis Set||participants|||Number
52307|NCT01294371|Secondary|Percent Compliance to Treatment With Leuprorelin|Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100.|6 months|Participants who received at least one dose of leuprorelin.||percent compliance||Standard Deviation|Mean
52396|NCT01292603|Secondary|Part 2: Total CD19+ B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n = number of participants analyzed at the specified visit.||cells/μL||Full Range|Median
52308|NCT01294371|Primary|Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment|The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.|6 months|Full Analysis Set included all all patients who had signed the personal authorization form and who administered at least one dose of leuprorelin and who had attended at least one post-baseline visit.||percentage of participants|||Number
52309|NCT01294306|Secondary|Median Overall Survival|Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.|Up to 2 Years|||Months||95% Confidence Interval|Median
52310|NCT01294306|Secondary|Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride|Toxicities of Grade 3 or higher Attributed to Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Time Frame: Up to 2 years|||participants|||Number
52311|NCT01294306|Secondary|Median Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|||Months||95% Confidence Interval|Median
52312|NCT01294306|Primary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR|Up to 2 years|||percentage of subjects|||Number
52313|NCT01294306|Primary|Disease-control Rate|Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|At 12 weeks|||percentage of subjects|||Number
52314|NCT01294228|Primary|The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.|The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.|Prior to or within 72 hours.|Study participants who had both an adjudicated AKI diagnosis and an evaluable T=0 (study enrollment) blood collection and associated test results.||Probability||95% Confidence Interval|Number
52315|NCT01294163|Primary|Log-transformed Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The non-inferiority comparison between Xenon and Sevoflurane was repeated using log-transformed blood troponin levels on the PP Set.||ng/mL||95% Confidence Interval|Least Squares Mean
52316|NCT01294163|Secondary|Presence of Absence of Adverse Events, Including Myocardial Infarction||7 days||||||
52317|NCT01294163|Secondary|Vital Signs||7 days||||||
52318|NCT01294163|Secondary|ECG Abnormalities||7 days||||||
52319|NCT01294163|Secondary|Clinical Laboratory Tests||7 days||||||
52320|NCT01294163|Secondary|Presence or Absence of Postoperative Delirium|Confusion Assessment Method|7 days||||||
52321|NCT01294163|Secondary|Haemodynamic Profile|Monitoring of heart rate, arterial blood pressure, central venous pressure.|4 hours||||||
52322|NCT01294163|Secondary|Arterial Oxygen Saturation|Arterial blood gases|4 hours||||||
52323|NCT01294163|Secondary|Depth of Anaesthesia|On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)|4 hours||||||
52324|NCT01294163|Primary|Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The primary analysis was a non-inferiority comparison between Xenon and Sevoflurane and was performed on the Per Protocol (PP) Set composed of all randomised and treated patients with no major protocol deviations during the study.||ng/mL||95% Confidence Interval|Least Squares Mean
52325|NCT01294150|Secondary|Sexual Function|Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months.|12 Months|||% of Subjects|||Number
52326|NCT01294150|Primary|Mean UroLift Improvement in IPSS at 12 Months|The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.|12 months|||% IPSS Score Improvement||97.5% Confidence Interval|Number
52327|NCT01294150|Primary|Comparison of IPSS for Efficacy|"The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone.~The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH).~SCORING:~0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|3 month|||IPSS total score||Standard Deviation|Mean
52464|NCT01292226|Secondary|Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint|TNF gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
52328|NCT01294150|Primary|Collection of Post-treatment Catheterization for Safety|The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.|Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days|||participants|||Number
52329|NCT01293968|Secondary|The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed|4 days after the solution consumption||||||
52330|NCT01293968|Primary|Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution|four days after the start of the study|The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS||scores in Visual Analogue Scale||95% Confidence Interval|Mean
52331|NCT01293825|Secondary|Quality of Life Score as Measured by 12-item Short Form Health Survey|Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
52332|NCT01293825|Secondary|Body Weight||Week 16|||lbs||Standard Deviation|Mean
52333|NCT01293825|Secondary|Young Mania Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
52334|NCT01293825|Secondary|Montgomery Asberg Depression Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
52335|NCT01293825|Secondary|Social and Occupational Functioning Scale|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
52336|NCT01293825|Secondary|Global Psychopathology Score as Measured by Clinical Global Impressions|Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976). Lower scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
52337|NCT01293825|Secondary|Attitude Toward Medication Score as Measured by the Drug Attitude Inventory|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
52338|NCT01293825|Secondary|Treatment Adherence Score as Measured by the Morisky Rating Scale|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Week 16|||units on a scale||Standard Deviation|Mean
52339|NCT01293825|Primary|Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)|Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.|Week 16|||Percentage of doses||Standard Deviation|Mean
52340|NCT01293695|Primary|Hot Flash Related Daily Interference Scale (HFRDIS)|This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.|6 Weeks and 12 Weeks|||units on a scale||Standard Deviation|Mean
52341|NCT01293695|Secondary|Pittsburg Sleep Quality Index (PSQI)|The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rate their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score is determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.|6 Weeks and 12 Weeks|||units on a scale||Standard Deviation|Mean
52342|NCT01293695|Secondary|Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture|As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.|6 Weeks and 12 Weeks|Analysis was conducted on all available physiological data to determine hot flash frequency. Data was missing for 29 participants in the hypnosis group and 17 participants in the structured attention group.||Micro Siemens||Standard Deviation|Mean
52343|NCT01293695|Primary|Hot Flash Score|"Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).~Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).~The values presented represent the average of daily hot flash scores."|6 Weeks and 12 Weeks|||units on a scale||Standard Deviation|Mean
52344|NCT01293695|Primary|Hot Flash Frequency|The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).|6 Weeks and 12 Weeks|||hot flashes per week||Standard Deviation|Mean
52397|NCT01292603|Secondary|Part 1: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.||percentage of participants|||Number
52345|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||logMAR|Participants|Standard Deviation|Mean
52346|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||logMAR|Participants|Standard Deviation|Mean
52347|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer’s eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale|Participants|Standard Deviation|Mean
52348|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer’s eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale|Participants|Standard Deviation|Mean
52349|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52350|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52351|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52352|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52353|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52354|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52355|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52356|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
52357|NCT01293084|Secondary|Percent Mucociliary Clearance at 90 Minutes||90 minutes|Data for participants that completed and received both 7% saline and 0.12% saline.||percentage mucociliary clearance||Inter-Quartile Range|Median
52358|NCT01293084|Primary|Percent Mucociliary Clearance at 60 Minutes||60 minutes|Participants that completed received both 7% saline and 0.12% saline over the duration of the study||percentage mucociliary clearance||Inter-Quartile Range|Median
52398|NCT01292603|Secondary|Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.||cells per microliter (cells/μL)||Full Range|Median
52359|NCT01293032|Primary|The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment|The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.|Up to 2 years|Patients with an intermediate RS(11-25) assigned to Group 2, Arm 1, and Arm 2 were combined in the analysis.||proportion of participants||95% Confidence Interval|Number
52360|NCT01293006|Secondary|Mean Arterial SaO2 During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant on mean oxygen saturation (SaO2) during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
52361|NCT01293006|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment. Sleep stages were determined by polysomnography.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
52362|NCT01293006|Secondary|Mean Apnea/Hypopnea Index (AHI)|Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Events per hour||95% Confidence Interval|Least Squares Mean
52363|NCT01293006|Secondary|Percentage of Total Sleep Time in Which SaO2 is Less Than 90%, 85% or 80%|Evaluation of the percentage of the night in which SaO2 is less than 90%, less than 85% and less than 80% following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Percentage of Total Sleep Time||95% Confidence Interval|Least Squares Mean
52364|NCT01293006|Primary|Number of Participants Discontinued From Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 15 days|All participants were included in the Safety Population.||participants|||Number
52365|NCT01293006|Primary|Number of Participants With Adverse Events|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.||participants|||Number
52366|NCT01293006|Primary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant (MK-4305) on SaO2 during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
52367|NCT01292928|Other Pre-specified|Walking Improvement (Distance) Assessed by 6 Minute Hall Walk|Assessment of walking improvement by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects||meters||Standard Deviation|Mean
52368|NCT01292928|Other Pre-specified|Quality of Life|Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Quality of Life Analysis were available for 265 subjects||units on a scale||Standard Deviation|Mean
52369|NCT01292928|Other Pre-specified|Walking Improvement (Time) Assessed by 6 Minute Hall Walk|Assessment of walking improvement by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects||minutes||Standard Deviation|Mean
52399|NCT01292603|Secondary|Part 2: Percentage of Participants With Anti-Rituximab Antibodies|In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.|Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.|SAP; n = number of participants analyzed for the specific parameter.||percentage of participants|||Number
52370|NCT01292928|Other Pre-specified|Walking Improvement Assessed by the Walking Impairment Questionnaire|The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement assessed by the Walking Impairment Questionnaire were available for 265 subjects||units on a scale||Standard Deviation|Mean
52371|NCT01292928|Other Pre-specified|Rate of Hemodynamic Improvement|"The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.~Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR.~Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR."|12 months|278 subjects were included in the Rate of Hemodynamic Improvement Analysis (275 subjects eligible for the 12-Month Follow-Up + 3 subjects with TLR)||percentage of limbs|Participants||Number
52372|NCT01292928|Other Pre-specified|Rutherford Classification|"Class 0: Asymptomatic~Class 1: Mild claudication~Class 2: Moderate claudication~Class 3: Severe claudication~Class 4: Ischemic rest pain~Class 5: Minor tissue loss – nonhealing ulcer, focal gangrene with diffuse pedal edema~Class 6: Major tissue loss – extending above metatarsal (MT) level~Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR.~Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.~Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure"|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Rutherford Classification Analysis was available for 263 subjects||percentage of participants|||Number
52373|NCT01292928|Other Pre-specified|Stent Fracture Rate|"Vascular InterVentional Advances (VIVA) definitions:~Grade 0: No strut fractures~Grade I: single strut fracture~Grade II: multiple strut fractures~Grade III: stent fracture(s) with preserved alignment of the components~Grade IV: stent fracture(s) with mal-alignment of the components~Grade V: stent fracture(s) in a trans-axial spiral configuration"|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Stent Fracture Analysis were available for 248 subjects||percentage of stents|Participants||Number
52374|NCT01292928|Other Pre-specified|Assisted Primary Patency|Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Assisted Primary Patency Analysis was available for 247 subjects||percentage of lesions||95% Confidence Interval|Number
52375|NCT01292928|Other Pre-specified|Primary Patency|Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Patency Analysis was available for 262 subjects/lesions||percentage of lesions|Participants|95% Confidence Interval|Number
52376|NCT01292928|Other Pre-specified|Technical and Procedural Success|"Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%~Procedural success: technical success with no MAEs within 24 hours of the procedure"|Up to 24 hours after the procedure|||percentage of participants||95% Confidence Interval|Number
52377|NCT01292928|Secondary|Secondary Safety Endpoint and Components|The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month|1 month|From the 299 enrolled subjects, data for the Secondary Safety Endpoint was available for 297 subjects||percentage of participants||95% Confidence Interval|Number
52378|NCT01292928|Primary|Co-Primary Efficacy Endpoints|"The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure.~The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm).~The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm)."|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Co-Primary Efficacy Endpoints were available for 262 subjects||percentage of participants||95% Confidence Interval|Number
52379|NCT01292928|Primary|Primary Safety Endpoint and Components|The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months|1 month for death, 12 months for target limb major amputation , and target lesion revascularization|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Safety Endpoint were available for 268 subjects.||percentage of participants||95% Confidence Interval|Number
52380|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.|Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period."||participants|||Number
52381|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Treatment Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.|Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.||participants|||Number
52382|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period|The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period."||percentage of participants|||Number
52383|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.||percentage of participants|||Number
52384|NCT01292837|Secondary|The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period|"The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - E)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with combined Baseline Period and post-Baseline generalized tonic-clonic seizure counts. 12 of the 13 subjects in the FAS were included in the analysis excluding 1 subject discontinued before the Evaluation Period.||percent change||Standard Deviation|Mean
52385|NCT01292837|Primary|The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)|"The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - T)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.||percent change||Standard Deviation|Mean
52386|NCT01292798|Secondary|Qualitative Assessment of Diabetic Macular Edema (DME)|To compare the percentage of subjects with compete or partial/no resolution of diabetic macular edema in response to the ranibizumab 0.5 and 2.0 mg doses.|Baeline and 6 months|At 6 months, 18 out of the 43 subjects (42%) showed complete resolution of DME. 25 out of the 43 subjects (58%) showed partial or no resolution of DME at 6 months.||percentage of participants|||Number
52387|NCT01292798|Secondary|Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline|To determine the mean change in central 1-mm subfield thickness as measured by spectral-domain OCT from baseline to 6 months .|baseline and 6 months|||microns||Standard Deviation|Mean
52388|NCT01292798|Primary|Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline|To determine the mean change in the best-corrected visual acuity on an ETDRS visual acuity chart at a starting distance of 4 meters from baseline to 6 months.|baseline and 6 months|||letters||Standard Deviation|Mean
52389|NCT01292746|Primary|Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area|Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.|Baseline and 13 Weeks|||hairs/cm2||Standard Deviation|Mean
52390|NCT01292642|Secondary|Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks|The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction.|10 weeks|||Scores on a scale||Standard Deviation|Mean
52391|NCT01292642|Primary|Cannabis Use|cannabis inhalations per day|Baseline and 10 weeks|||cannabis inhalations/day||Standard Deviation|Mean
52392|NCT01292642|Primary|Cigarette Use|cigarettes per day|Baseline and 10 weeks|||cigarettes/day||Standard Deviation|Mean
52393|NCT01292629|Secondary|Complications and Adverse Events|Number of Participants with Complications or Adverse Events|4 to 6 months|||participants|||Number
52394|NCT01292629|Primary|Visual Acuity|BEST Spectacle-Correction (ETDRS) Distance Visual Acuity|4 to 6 months|125 subjects enrolled in the study, 121 were examined at the Form 4 and the remaining four (3.2%) subjects missed the Form 4 visit but were examined later. 121 subjects were evaluated for primary and secondary effectiveness and safety outcomes.||subjects|||Number
52395|NCT01292603|Secondary|Part 2: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n= number of participants analyzed at the specified visit.||percentage of participants|||Number
52400|NCT01292603|Secondary|Part 1: Percentage of Participants With Anti-Rituximab Antibodies|Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.|Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose|Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.||percentage of participants|||Number
52401|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question: Which formulation of rituximab (SC or IV) do you think is more convenient? with pre-specified responses as below. Percentage of participants with specified answers were reported.~A - Rituximab SC is much more convenient.~B - Rituximab SC is a little more convenient.~C - Both formulations are equally convenient.~D - Rituximab IV is a little more convenient.~E - Rituximab IV is much more convenient"|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis. n = number of physicians or nurses that responded to the survey.||percentage of participants in the survey|||Number
52402|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question:  If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones). Percentage of participants with specified answers were reported.~A- Less than 1 hour~B- At least 1 hour but less than 2 hours~C- At least 2 hours but less than 3 hours~D- At least 3 hours but less than 4 hours~E- 4 or more hours"|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis. number (n) = number of physicians or nurses that responded to the survey.||percentage of participants in the survey|||Number
52403|NCT01292603|Secondary|Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration|In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC|Days 4 to 5 in Cycle 6|All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.||percentage of participants or nurses|||Number
52404|NCT01292603|Secondary|Part 2: Terminal Half-Life of Rituximab at Cycle 6|The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
52405|NCT01292603|Secondary|Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6|Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||days||Geometric Coefficient of Variation|Geometric Mean
52406|NCT01292603|Secondary|Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6|Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
52407|NCT01292603|Secondary|Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6|"AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below:~Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)– ln(AUC IV)."|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.||μg*day/mL||Geometric Coefficient of Variation|Geometric Mean
52408|NCT01292603|Primary|Part 2: Rituximab C Trough Levels at Cycle 5|Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.|+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration|Only participants who entered Part 2 of the study and had pharmacokinetic (PK) data available were included in the analysis.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
52423|NCT01292473|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
52465|NCT01292226|Secondary|Interleukin 8 (IL-8) Expression by Visit and Timepoint|IL-8 gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
52409|NCT01292603|Primary|Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab|Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.|Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose|Enrolled (non-randomized) Pharmacokinetic Evaluable Population (Part 1) included all participants from Part 1 who did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or have unavailable or incomplete data which could influence the pharmacokinetic analysis.||mg|||Number
52410|NCT01292538|Secondary|Body Weight (Pounds)||2 weeks||||||
52411|NCT01292538|Secondary|Subject Self-reported Satisfaction With Study Outcome||2 weeks||||||
52412|NCT01292538|Secondary|Body Mass Index (BMI)||2 weeks||||||
52413|NCT01292538|Primary|Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs|Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.|2 weeks|||inches||Standard Deviation|Mean
52414|NCT01292486|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product White Blood Cells (WBC) that were segmented granulocytes or bands.|7 days|Data to calculate the percent of product WBCs that were segmented granulocytes or bands was available for 38 MNC collections on 25 of the 26 per protocol patients.||percentage of product WBCs|Participants|Full Range|Median
52415|NCT01292486|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.|7 days|Data was available from 38 MNC collections from 25 of the 26 per protocol patients.||hematocrit %|Participants|Full Range|Median
52416|NCT01292486|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|up to 7 days|Data to calculate platelet collection efficiency was available for 38 MNC collections on 24 of the 26 per protocol patients.||% of processed platelets collected|Participants|Full Range|Median
52417|NCT01292486|Secondary|Mononuclear Cel (MNC) Collection Efficiency|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.~Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%."|up to 7 days|Data was available to calculate MNC collection efficiency on 35 collections performed on 22 of the 26 per protocol patients.||% of processed MNCs that were collected|Participants|Full Range|Median
52418|NCT01292486|Secondary|CD34+ Cell Collection Efficiency.|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.~CD34+ is a cell surface marker found on pluripotent hematopoeitic stem cells."|up to 7 days|Data to calculate CD34+ cell collection efficiency was available for 39 collections on 24 of 26 per protocol patients.||% of processed CD34+ cells collected|Participants|Full Range|Median
52419|NCT01292486|Secondary|Days Until Platelet Recovery|The time to platelet recovery is defined as the day following stem-cell transplant (Day 0) on which the platelet count exceeds 20,000/μL, for the first of three consecutive measurements obtained on different days, without platelet transfusion support within the preceding 7 days.|up to 28 days following transplant|All per protocol patients for whom platelet recovery data was available.||days||Full Range|Median
52420|NCT01292486|Primary|Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.|"Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease.~As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D > |2|, where D = Observed median day of neutrophil recovery – Site specific historic median day of neutrophil recovery."|up to 28 days following transplant|Twenty-six patients were evaluable per protocol.||Days||Full Range|Median
52421|NCT01292473|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.||Percentage of days||Standard Deviation|Mean
52422|NCT01292473|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12|The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug and who had a DLQI score at Week 12.||Units on a scale||Standard Deviation|Mean
52424|NCT01292473|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.~The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline."|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Percentage of participants|||Number
52425|NCT01292473|Secondary|Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Percentage of participants|||Number
52426|NCT01292473|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.~The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved."|by Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Weeks||95% Confidence Interval|Median
52427|NCT01292473|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
52428|NCT01292473|Secondary|Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
52429|NCT01292473|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.||Units on a scale||Standard Deviation|Mean
52430|NCT01292304|Secondary|Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)|This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.|12 weeks of study drug|||Days||Full Range|Median
52431|NCT01292304|Primary|Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)|This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)|12 weeks of study drug|||participants|||Number
52432|NCT01292304|Secondary|Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)|Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L|12 weeks|||participants|||Number
52433|NCT01292304|Secondary|Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)|Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing|12 weeks|||participants|||Number
52434|NCT01292304|Primary|Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)|Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing|Week 12|||participants|||Number
52435|NCT01292265|Secondary|Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
52436|NCT01292265|Secondary|Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
52437|NCT01292265|Secondary|Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.|||||
52439|NCT01292239|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for all participants in the TMC435 treatment group who received TMC435 for up to 12 weeks. The time frame of “Overall” (up to Week 12) represents the median exposure estimate using all available data for each participant in the study.|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng.h/mL||Full Range|Median
52440|NCT01292239|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) maximum plasma concentration (Cmax) values for TMC435 for all participants in the TMC435 treatment group. The time frame of “Overall” (up to Week 12) represents the median exposure estimate using all available data for each participant in the study.|Overall (ie, Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
52441|NCT01292239|Secondary|The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in the TMC435 treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with pegIFN alpha 2a and RBV at Week 24. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group continued treatment with PegIFN alpha 2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52442|NCT01292239|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline (Day 1) who achieved normal ALT levels at the EOT (up to Week 24 or 48). At Baseline, 61/123 participants in the TMC435 treatment group and 25/60 participants in the Placebo treatment group had abnormal ALT levels. At the EOT, 47 (77.0%) participants in the TMC435 treatment group and 18 (72.0%) participants in the Placebo treatment group had ALT levels that returned to normal (or normalization of ALT levels defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT.).|Baseline (Day 1) to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52443|NCT01292239|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) at the End of Treatment (EOT) (up to Week 24 or 48) and detectable HCV RNA during follow-up or detectable plasma levels of HCV RNA at the time points of sustained virologic response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable plasma levels of HCV RNA at the EOT and with at least one follow-up HCV RNA. measurement.|Up to Week 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52444|NCT01292239|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of > 1 log10 IU/mL in plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA)l from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period (up to the end of treatment [EOT]).|Up to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52445|NCT01292239|Secondary|The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable plasma levels of HCV RNA <1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at the EOT (up to Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52446|NCT01292239|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in plasma levels of HCV RNA at each time point during treatment and post-treatment follow-up (FU).|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60, 72, EOT (up to Week 24 or 48), FU Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52466|NCT01292226|Secondary|IMPDH Expression II by Visit and Timepoint|IMPDH II gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
52447|NCT01292239|Secondary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT, defined as up to Week 24 or 48) and at 24 weeks after the last dose of treatment (up to Week 48 or 72).|EOT (up to Week 24 or 48) and 24 weeks after the after the last dose of treatment (up to Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52448|NCT01292239|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52449|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples||correlation coefficient|Participants||Number
52450|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples||correlation coefficient|Participants||Number
52451|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples||correlation coefficient|Participants||Number
52452|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population||correlation coefficient|Participants||Number
52453|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population||correlation coefficient|Participants||Number
52454|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
52455|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
52456|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
52457|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
52458|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
52459|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed||correlation coefficient|Participants||Number
52460|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.||correlation coefficient|Participants||Number
52467|NCT01292226|Secondary|IMPDH Expression I by Visit and Timepoint|IMPDH I gene expression was measured by real time polymerase chain reaction (QRT-PCR) based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of messenger ribonucleic acid (mRNA) copies per cell (copies/cell).|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||number of mRNA copies/cell|Participants|Standard Deviation|Mean
52468|NCT01292226|Secondary|Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint|"IMPDH activity in peripheral blood mononuclear cells (PBMCs) was measured at 2 timepoints per visit, 0 and 120 minutes and presented in enzyme units. The unit of measure of enzyme activity is U. One U is defined as the amount of the enzyme that produces a certain amount of enzymatic activity that is, the amount that catalyzes the conversion of 1 micro mole of substrate per minute under pre-specified conditions (temperature, pH)."|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.||enzyme units|Participants|Standard Deviation|Mean
52469|NCT01292226|Secondary|MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit|The AUC0-12 of MPA was estimated on the validated limited sampling strategy, AUC (milligrams multiplied by height over liter [mg.h/L]) = 7.182 + 4.607 multiplied by (*) concentration at 0 minutes (C0)+ 0.998 * the concentration at 40 minutes (C0.67) + 2.149 * the concentration at 120 minutes (C2).|Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mcg*hr/mL||Standard Deviation|Mean
52470|NCT01292226|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)|BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population||percentage of participants|||Number
52471|NCT01292226|Secondary|Free MPA (mcg/mL) by Visit|Drug quantification of free MPA in the plasma was measured at T = 0, 40, and 120 mins.|Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits|ITT population; n=number of samples analyzed.||mcg/mL|Participants|Standard Deviation|Mean
52472|NCT01292226|Secondary|Total Mycophenolate Acid (MPA) by Visit and Timepoint|Drug quantification of total MPA (micrograms per milliliter [mcg/mL]) in the plasma was measured at time (T) = 0 minutes (min), 40 mins, and 120 mins.|Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits|ITT population; n=number of samples analyzed.||mcg/mL|Participants|Standard Deviation|Mean
52473|NCT01292226|Secondary|Percentage of Participants Surviving||Day 1, Weeks 2, 4, 12, 24, and 28|ITT population||percentage of participants|||Number
52474|NCT01292226|Secondary|Percentage of Participants With Graft Loss|An allograft was presumed to be lost if a participant started dialysis and was not able to subsequently be removed from dialysis.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population||percentage of participants|||Number
52475|NCT01292226|Primary|Time to Rejection|The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population; only participants with acute or biopsy-proven rejection were included in the analysis.||days||Standard Deviation|Mean
52476|NCT01292226|Primary|Percentage of Participants With Acute Rejection|Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.|Day 1, Weeks 2, 4, 12, 24, and 28|Intent-to-treat (ITT) population: all eligible participants who had at least baseline (BL) and 1 assessment of pharmacokinetics (PK) and pharmacodynamics (PD). Acute rejection was analyzed in any participant with an increase in serum creatinine of 25%.||percentage of participants|||Number
52477|NCT01292187|Secondary|Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.||Baseline, Week 54|MITT population||percent change||95% Confidence Interval|Least Squares Mean
52478|NCT01292187|Primary|Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.||Baseline, Week 54|MITT population||percent change||95% Confidence Interval|Least Squares Mean
52479|NCT01292135|Secondary|Progression Free Survival Rate at 12 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.|||Percentage of Participants||95% Confidence Interval|Number
52480|NCT01292135|Secondary|Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline||From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.|No participants in the FCR group had neutropenia, anemia or thrombocytopenia at baseline.||Percentage of Participants||95% Confidence Interval|Number
52481|NCT01292135|Secondary|Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.|From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants||95% Confidence Interval|Number
52482|NCT01292135|Secondary|Overall Incidence of Serious Adverse Events (SAEs)||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|||Percentage of Participants|||Number
52485|NCT01292135|Primary|Incidence of Prolonged Hematologic Toxicity Started in Cycle 1||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|The FCR arm was discontinued due to very limited use of this chemo regimen in this setting, statistical analysis were limited due to the small numbers of subjects in this treatment arm.||Percentage of Participants||95% Confidence Interval|Number
52486|NCT01292070|Primary|Difference in the Doses of GFD and CAT Required to Elicit a Cutaneous Reaction Demonstrated by a Wheal Greater Than or Equal to 10 mm With Surrounding Erythema|Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.|up to 3 hours after the last injection of GFD|The experimental protein (human Fcgamma1-Fel d1 fusion protein (GFD)) and the control protein (standardized cat hair allergenic extract (CAT)) elicited comparable reactivity in the first four participants dosed; thus, the trial was discontinued for futility and the primary endpoint was not evaluated|||||
52487|NCT01292005|Secondary|Number of Subjects Who Needed an Intensive Care Unit Stay||30 days, or until dismissal, whichever came first|||participants|||Number
52488|NCT01292005|Secondary|Length of Intensive Care Unit (ICU) Stay||30 days or until dismissal date, whichever occurs earlier|||Days||Full Range|Median
52489|NCT01292005|Secondary|Length of Hospital Stay||30 days or until dismissal date, whichever occurs earlier|||days||Full Range|Median
52490|NCT01292005|Secondary|Number of Patients With Lengthy Hospital Stays|"Lengthy was defined as either greater than 4 days or greater than 10 days."|30 days or until dismissal date, whichever occurs earlier|||participants|||Number
52491|NCT01292005|Secondary|Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization||1 week or until dismissal date whichever occurs earlier|||participants|||Number
52492|NCT01292005|Secondary|Number Of Subjects With New Onset Organ Failure During Hospitalization||1 week or until dismissal date whichever occurs earlier.|||participants|||Number
52493|NCT01292005|Primary|Changes in Interleukin (IL) IL-8|Normal value range for IL-8 = 0 - 5 pg/ml.|baseline, Day 1, Day 3|||pg/ml||Full Range|Median
52494|NCT01292005|Primary|Change in Interleukin (IL) IL-6|Normal value range for IL-6 = 0 - 5 pg/ml.|baseline, Day 1, Day 3|||pg/ml||Full Range|Median
52495|NCT01292005|Primary|Change in Tumor Necrosis Factor (TNF)-Alpha|Normal value range for TNF alpha = 0 - 22 pg/ml.|baseline, Day 1, Day 3|||pg/ml||Full Range|Median
52496|NCT01292005|Primary|Change in C-Reactive Protein (CRP)|C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.|baseline, Day 1, Day 3|||mg/L||Full Range|Median
52497|NCT01291784|Secondary|JAK2V617F Allele Burden|Investigate exploratory markers, hematopoietic cells, for their ability to predict responsiveness to treatment with GC1008. Analysis of percentage of mutant alleles in hematopoietic stem cells.|6 months|||percentage of mutant alleles|||Number
52498|NCT01291784|Secondary|Peripheral Blood CD34+|Investigate exploratory markers for their ability to predict responsiveness to treatment with GC1008.|6 months|||percentage of hematopoietic stem cells|||Number
52499|NCT01291784|Secondary|European Consensus Fibrosis Grade|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by European consensus grading system.~This scheme consists of a qualitative (reticulin or collagen) and quantitative evaluation of bone marrow fibrosis and distinguishes four increasing categories, ranging from MF-0, which corresponds to normal bone marrow, to MF-3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis."|6 months|||units on a scale|||Number
52500|NCT01291784|Secondary|Bauermeister Scale|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by Bauermeister scale.~Bauermeister scale: 0, no demonstrable reticulin fibers; 1, occasional fine individual fibers and foci of a fine-fiber network; 2, fine fiber network throughout most of the section, but no coarse fibers; 3, diffuse fiber network with scattered thick coarse fibers, but no mature collagen; and 4, diffuse, often coarse fiber network with areas of collagen."|6 months|||units on a scale|||Number
52501|NCT01291784|Primary|Safety and Tolerability|"To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).~A total of 9 AEs determined by the investigator to be at least possibly related to GC1008 occurred during the study."|28 days|||events|||Number
52502|NCT01291498|Secondary|Voice Morbidity|Voice Handicap Index. 30 questions rated on a five point scale from 'never' to 'always' and an overall score from 1 'normal' to 10 'severely impaired'|Up to one year post-treatment|||units on a scale|||Number
52503|NCT01291498|Secondary|Eucalcaemia|Ca in plasma|Six weeks post-treatment.Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.|Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.||mmol/L|||Number
52504|NCT01291498|Primary|Eucalcaemia|Calcium in the blood is measured from venepuncture|12 months post-treatment|The primary endpoint was not analysed because only one subject was entered and this subject was withdrawn from the study before 12 months after treatment.|||||
52505|NCT01291277|Primary|Proportion of Patients With Eradication of Esophageal Varices||At 4 weeks|||Participants|||Count of Participants
52506|NCT01291264|Primary|Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.|This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit.|1 day - (At clinic visit)|per protocol||Positive test result|||Number
52507|NCT01291225|Secondary|Playground and Farm Safety Knowledge, Attitudes and Practices Composite Scores|The investigators hypothesize that the improvement in the playground safety Knowledge, Attitudes, and Practices (KAP) survey composite scores and farm audits from the baseline in year 1 to the follow-up in year 3 will be significantly greater for parents residing in Ross County than for parents in the non-intervention counties (Morrow and Pickaway).The playground safety KAP survey consisted of 7 items and individuals could receive a summed score of 0-7, with a score of 7 indicating mastery of the material.|Year 1 baseline to Year 3 follow-up|||composite score||Standard Deviation|Mean
52508|NCT01291225|Primary|Change in Playground Hazards|The investigators hypothesize that the decrease in the number of identified playground hazards (comparing each playground to itself from the year 1 baseline survey to the year 3 follow-up survey utilizing a playground hazards checklist) will be significantly greater for the intervention playgrounds compared with non-intervention playgrounds in Circleville, Pickaway Co. The percentage increase in the number of playgrounds with adequate safety surfacing will be used as a proxy for playground hazardousness.|Year 1 baseline to year 3 follow-up|||% increase playgrounds w/surfacing|||Number
52509|NCT01291173|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
52510|NCT01291173|Secondary|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11|The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 – 120. Higher scores indicate increased impulsiveness.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
52511|NCT01291173|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 11|The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
52512|NCT01291173|Secondary|Change From Baseline in Eating Inventory Score at Week 11|The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
52513|NCT01291173|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11|The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
52514|NCT01291173|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
52515|NCT01291173|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11|The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
52516|NCT01291173|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)||Percentage of participants|||Number
52517|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)||Percentage of participants|||Number
52518|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)||Percentage of participants|||Number
52520|NCT01291173|Secondary|1-Week Binge Response, Last Observation Carried Forward (LOCF)|The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.|Last 7 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Participants|||Number
52521|NCT01291173|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks|The number of binge episodes per week as assessed by clinical interview based on subject diary.|Baseline and up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Binge Episodes||Standard Deviation|Mean
52522|NCT01291173|Primary|Change From Baseline in Log Transformed Binge Days Per Week at Week 11|Binge day is defined as a day during which at least 1 binge episode occurs.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.||Log days||Standard Error|Least Squares Mean
52523|NCT01291160|Primary|Number of 100% Wound Closure||before or at week 12|Analyzed the per-protocol population||percentage of patients|||Number
52524|NCT01291108|Secondary|Change From Baseline in Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
52525|NCT01291108|Primary|Change From Baseline in Average Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
52526|NCT01291056|Primary|Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Physical symptoms were calculated to give the total score. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
52527|NCT01291056|Primary|Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
52528|NCT01291056|Primary|Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 Year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
52529|NCT01291056|Primary|Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.||units on a scale||Full Range|Median
52530|NCT01291017|Secondary|Grade of Study Drug Toxicity|The number of all toxicities and grades 3 and 4 (per CTCAE v3.0) toxicities that occured during the administration of the drug and during the follow up period.|24 months|||Events|||Number
52531|NCT01291017|Secondary|Plasma Levels|Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.|6 months|4 of the 16 samples were tested by protein immunoblot (Western blot), and due to the test not being sensitive enough to detect p16, phosphorylated RB or cyclin D1 protein bands in any of the samples, the decision was made not to purse this testing any further.||Arbitrary Units|||Number
52532|NCT01291017|Secondary|Progression-free Survival|Median progression-free survival.|12 months|||Weeks||Standard Error|Median
52533|NCT01291017|Secondary|Overall Survival|Median overall survival|14 months|||weeks||Standard Error|Median
52534|NCT01291017|Primary|Tumor Response by Direct RECIST Measurement|Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.|6 months|||participants|||Number
52535|NCT01290978|Secondary|Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively|Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction)|30 minutes|The number of participants was determined to provide 80% power to detect a difference of 20% for the drape by prep comparisons||units on a scale||Standard Deviation|Mean
52536|NCT01290978|Primary|Drape Adhesion|The peel force to remove the sample|30 minutes|Data analysis per protocol||grams-force||95% Confidence Interval|Mean
52729|NCT01289548|Secondary|Urine Concentration of RBP Preoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) before the operation in the recipients|before the operation|No urine could be obtained from the other 46 patients because of anuria.||mg/L||Standard Deviation|Mean
52540|NCT01290913|Primary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg)|To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.|First day of desensitization|||participants|||Number
52541|NCT01290887|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|"Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive.~Predose samples for the reslizumab-experienced participants came from the previous studies."|Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|Safety analysis set of participants with assessments at stated timeframes||participants|||Number
52542|NCT01290887|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits."|Weeks 24, 48, 72, 96, End of Study and Endpoint|Safety analysis set of participants with assessments at stated timeframes||units on a scale||Standard Deviation|Mean
52543|NCT01290887|Secondary|Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||units on a scale||Standard Deviation|Mean
52544|NCT01290887|Secondary|Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||units on a scale||Standard Deviation|Mean
52545|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit.~Significance criteria~Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages)~Sitting heart rate-low: <50 and decrease of >=30 beats/min~Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17)~Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18)~Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18)~Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17)~Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17)~Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18)~Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18)~Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17)~Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18)~Body temperature-low: <96.5° Fahrenheit (all ages)~Body temp-high: >100.5° F (all ages)"|Week 4 to Week 65|Safety analysis set, including participants who contributed to the analysis||participants|||Number
52546|NCT01290887|Secondary|Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||# puffs/day||Standard Deviation|Mean
52547|NCT01290887|Secondary|Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||liters/second||Standard Deviation|Mean
52548|NCT01290887|Secondary|Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||liters||Standard Deviation|Mean
52549|NCT01290887|Secondary|Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||percentage of predicted FEV1||Standard Deviation|Mean
52550|NCT01290887|Secondary|Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes||liters||Standard Deviation|Mean
52551|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.~Total bilirubin: >=34.2 μmol/L~White blood cells- low: <=3.0*10^9/L~White blood cells-high: >=20*10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Platelets: >=700*10^9/L~Absolute neutrophil count: <=1.0*10^9/L~Eosinophils: >=10~Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline"|Weeks 4, 8, 24 and 48|Safety analysis set, including participants who contributed to the analysis||participants|||Number
52552|NCT01290887|Primary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set||participants|||Number
52553|NCT01290822|Secondary|Interventricular Synchrony||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
52554|NCT01290822|Secondary|Peak RV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
52555|NCT01290822|Secondary|Peak LV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
52556|NCT01290822|Secondary|Interatrial Delay (Between Right Atrium and Left Atrium)|Results could not be analyzed due to poor enrollment and lack of data.|13 minutes of testing; performed before CPB for allograft receipt||||||
52557|NCT01290822|Secondary|Atrial Latency||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
52558|NCT01290822|Primary|Cardiac Output|The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.|13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.|||||
52559|NCT01290796|Secondary|Operative, Perioperative and Long-term Complications||Day 0 through 36-months post procedure||||||
52560|NCT01290796|Primary|Percentage of Patients Who Showed Improvement in Self-reported SUI Symptoms|Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).|12-months post procedure|||percentage of participants||95% Confidence Interval|Number
52561|NCT01290796|Primary|Percentage of Patients Free of Stress Urinary Incontinence|Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.|12-months post surgical procedure|||percentage of participants||95% Confidence Interval|Number
52562|NCT01290757|Secondary|AUC0-∞ of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
52563|NCT01290757|Secondary|Cmax of Free Dabigatran in Plasma.|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
52564|NCT01290757|Secondary|AUC0-tz of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
52565|NCT01290757|Secondary|Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
52566|NCT01290757|Primary|Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
52567|NCT01290757|Primary|Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran|Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|This subject set, the pharmacokinetic set (PKS), includes all subjects of the treated set who provide at least one evaluable observation for at least one of the three PK endpoints of total dabigatran, which is obtained in a period without important protocol violations relevant to the evaluation of bioequivalence.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
52675|NCT01289847|Secondary|Therapeutic Efficacy|Number and proportion of subjects who maintain trough IgG levels at least as high as the average of the 2 previous trough levels before the first Gammaplex infusion|From week 15 onwards|Seven subjects (28.0%) maintained trough IgG levels at all visits that were at least as high as the average of the two previous levels before the first infusion||participants|||Number
52568|NCT01290731|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels (defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT). At baseline, 15/49 participants had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52569|NCT01290731|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for all participants who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study. Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12).|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng.h/mL||Full Range|Median
52570|NCT01290731|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) TMC435 predose plasma concentration (C0h) values and the TMC435 maximum plasma concentration (Cmax) values for all participants who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study.Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12).|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
52571|NCT01290731|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at end of treatment (EOT) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of sustained virologic response (SVR) assessment . The incidence of viral relapse was calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52572|NCT01290731|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in particpants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The table below shows that no viral breakthrough was noted in any participants during the treatment period of the study.|Day 1 until end of treatment (EOT [Week 24 or 48])|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52573|NCT01290731|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (defined as less than 1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT [Week 24 or 48]).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52574|NCT01290731|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than or equal to 2 log10 IU/mL drop from baseline in plasma HCV RNA at each time point during treatment, at the end of treatment (Week 24 or 48), and post-treatment follow-up.|Days 3 and 7, Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52575|NCT01290731|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|The table below shows the percentage of participants with a SVR24 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|Week 48 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52576|NCT01290731|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|The table below shows the percentage of participants with an SVR12 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) 12 weeks after the last dose of treatment (Week 36 or 60).|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52577|NCT01290718|Secondary|Progression-Free Survival|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
52578|NCT01290718|Secondary|Overall Survival|Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
52579|NCT01290718|Secondary|Time to Disease Progression|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
52580|NCT01290718|Primary|Percentage of Participants With Overall Response|The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.|||||
52581|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work). The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism. The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group. The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60. The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52582|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities. The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores. The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52583|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores. The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52584|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504. The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group. The null hypothesis was that there would be no difference between the treatment arms in the FSS total score. The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52676|NCT01289847|Primary|Adverse Events|Number of subjects with serious, acute, bacterial infections as a measure of efficacy|12 months|Intent to Treat (ITT)||participants|||Number
52585|NCT01290679|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) of CL values of TMC435. NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below.|At protocol-specified time points at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||L/h||Standard Deviation|Mean
52586|NCT01290679|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) of C0h values of TMC435. NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12).|Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng/mL||Standard Deviation|Mean
52587|NCT01290679|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435.|At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng*h/mL||Standard Deviation|Mean
52588|NCT01290679|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Weeks||95% Confidence Interval|Median
52589|NCT01290679|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52590|NCT01290679|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||Standard Error|Mean
52591|NCT01290679|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52592|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52593|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows the median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52594|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52595|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52596|NCT01290679|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52597|NCT01290679|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52598|NCT01290679|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52599|NCT01290679|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52600|NCT01290679|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52601|NCT01290679|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52602|NCT01290679|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52603|NCT01290679|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52604|NCT01290679|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Weeks 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52605|NCT01290679|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52606|NCT01290679|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52607|NCT01290679|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52608|NCT01290679|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52609|NCT01290679|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
52610|NCT01290679|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows changes from baseline in log10 HCV RNA.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
52694|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52611|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52612|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52613|NCT01290679|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52614|NCT01290679|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52615|NCT01290666|Secondary|Duration of Drainage Post Procedure||Follow up out to 12 months post procedure||||||
52616|NCT01290666|Primary|Fistula Closure||12 months post procedure|||participants|||Number
52617|NCT01290640|Primary|In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|"Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation~The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative."|March 2013|||degrees|Participants|Standard Deviation|Mean
52618|NCT01290640|Primary|In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|March 2013|Per protocol.||mm|Participants|Standard Deviation|Mean
52619|NCT01290627|Primary|Normalized Lateral Patella Contact Point Translation|"full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||ratio of patella height|Participants|Standard Deviation|Mean
52620|NCT01290627|Primary|Normalized Medial Patella Contact Point Translation|"full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||ratio of patella height|Participants|Standard Deviation|Mean
52621|NCT01290627|Primary|Patella Tilt With Respect to Femur|full extension to maximum flexion|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||degrees|Participants|Standard Deviation|Mean
52622|NCT01290627|Primary|Patella Rotation With Respect to Femur|Patellar rotation from full extension to maximum flexion. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||degrees|Participants|Standard Deviation|Mean
52623|NCT01290627|Primary|Patella Flexion With Respect to Femur|Full extension to maximum flexion.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.|||degrees|Participants|Standard Deviation|Mean
52626|NCT01290536|Secondary|Radiographic Response|Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.|6 months after treatment|Response data are presented by primary disease sites: Colorectal (mCRC), Neuroendocrine (NET), and all other tumors. One patient with mCRC did not have follow-up cross-sectional imaging. Therefore, radiographic response data was available for 20 of 21 patients with mCRC.||participants|||Number
52627|NCT01290536|Primary|Number of Participants With Adverse Events|Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.|6 months|||participants|||Number
52628|NCT01290523|Secondary|Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1||6 months|||participants|||Number
52629|NCT01290523|Primary|Number of Participants With Adverse Events|Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain|6 months|||participants|||Number
52630|NCT01290484|Primary|Change in Volume of Lymphatic Malformation|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).|Baseline, 20 weeks|||percentage of volume change|||Number
52631|NCT01290341|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).~Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6|Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population.||percentage of subjects|||Number
52632|NCT01290341|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.~Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.||percentage of subjects|||Number
52633|NCT01290224|Secondary|Analgesic Use Over Time||On days 1-11 and for 10 weeks after therapy|||participants|||Number
52634|NCT01290224|Secondary|Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Day 1 to Day 10|||participants|||Number
52635|NCT01290224|Secondary|Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions|The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.|Day 1 and Week 10|||percentage of a scale||Standard Deviation|Mean
52636|NCT01290224|Secondary|Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question|The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.|Week 1 and Week 10|||percentage of reduction in symptom||Standard Deviation|Mean
52637|NCT01290224|Secondary|Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).|Day 1 and Day 10|||percentage of reduction in symptom||Standard Deviation|Mean
52638|NCT01290224|Secondary|Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.|On days 1 and 2|||units on a scale||Standard Deviation|Mean
52639|NCT01290224|Primary|Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire|CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.|On days 1 and 2|||Percentage of Participants|||Number
52640|NCT01290094|Secondary|Correlation Coefficient of Participant's Profile With Compliance|Participant's profile included age, year since menopause, fracture history, and BMD at baseline.|Baseline up to Month 12|ITT population.||correlation coefficient|||Number
52641|NCT01290094|Secondary|Percentage of Participants Who Received All Planned Study Medication (Compliance)||Baseline up to Month 12|ITT population.||percentage of participants|||Number
52695|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52642|NCT01290094|Secondary|Percent Change From Baseline in Total Hip T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.||percent change||Standard Deviation|Mean
52643|NCT01290094|Secondary|Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.||percent change||Standard Deviation|Mean
52644|NCT01290094|Primary|Percent Change From Baseline in Mean Hip BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.||percent change||Standard Deviation|Mean
52645|NCT01290094|Primary|Percent Change From Baseline in Mean Hip Bone BMD at Month 12|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.||percent change||Standard Deviation|Mean
52646|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.||percent change||Standard Deviation|Mean
52647|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|"Percent change was calculated as [(measure at time t minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.||percent change||Standard Deviation|Mean
52648|NCT01290029|Secondary|Percent Change From Baseline in Ionized Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Standard Deviation|Mean
52649|NCT01290029|Secondary|Percent Change From Baseline in Albumin Corrected Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Standard Deviation|Mean
52650|NCT01290029|Secondary|Percent Change From Baseline in Total Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Standard Deviation|Mean
52651|NCT01290029|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone||Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."||percent change||Inter-Quartile Range|Median
52652|NCT01290029|Secondary|Terminal Half-life of Cinacalcet|The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.|Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The T1/2 value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.||hours||Standard Deviation|Mean
52653|NCT01290029|Secondary|Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set||hours||Full Range|Median
52654|NCT01290029|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set||ng/mL||Standard Deviation|Mean
52655|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The AUCinf value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.||hr*ng/mL||Standard Deviation|Mean
52656|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set||hr*ng/mL||Standard Deviation|Mean
52696|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52657|NCT01290029|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.|Day 1 to day 30|All participants who received at least 1 dose of cinacalcet.||participants|||Number
52658|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment|Fasting plasma glucose - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF||mg/dL||Standard Error|Least Squares Mean
52659|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment|Fasting plasma glucose - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF||mg/dL||Standard Error|Least Squares Mean
52660|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment|Waist circumference (cm) - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF||cm||Standard Error|Least Squares Mean
52661|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment|Waist circumference (cm) - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF||cm||Standard Error|Least Squares Mean
52662|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 76 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial -LOCF||kg||Standard Error|Least Squares Mean
52663|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 52 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF||kg||Standard Error|Least Squares Mean
52664|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Diastolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF||mmHg||Standard Error|Least Squares Mean
52665|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Diastolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF||mmHg||Standard Error|Least Squares Mean
52666|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Systolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial -LOCF||mmHg||Standard Error|Least Squares Mean
52667|NCT01289990|Primary|Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment|Change from baseline in HbA1c after 76 weeks|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF)||% of HbA1c||Standard Deviation|Least Squares Mean
52668|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Systolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)||mmHg||Standard Error|Least Squares Mean
52669|NCT01289990|Secondary|HbA1c (%) Changes From Baseline After 76 Weeks of Treatment|Change from baseline in HbA1c (%) after 76 weeks using MMRM approach|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases)||% of HbA1c||Standard Error|Least Squares Mean
52670|NCT01289990|Primary|Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks|Baseline and 52 weeks|"Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.~(LOCF:Last observation carried forward)"||% of HbA1c||Standard Error|Least Squares Mean
52671|NCT01289847|Secondary|Therapeutic Efficacy|Number of days on therapeutic antibiotics|12 months|||days||Standard Deviation|Mean
52672|NCT01289847|Secondary|Therapeutic Efficacy|Visits to physicians and/or emergency room|12 months|||visits||Standard Deviation|Mean
52673|NCT01289847|Secondary|Therapeutic Efficacy|Number of days in hospital|12 months|||days||Standard Deviation|Mean
52674|NCT01289847|Secondary|Therapeutic Efficacy|Number of days off school|12 months|||days||Standard Deviation|Mean
52677|NCT01289821|Secondary|Duration of Stable Disease (DOSD)|DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD. DOSR was defined as the time (in days) from date of start of study treatment to the date at which disease progression or death (if death occurred before progression was first documented). The date the tumor scan was performed was used for this calculation. DOSD for participants without disease progression or death before progression at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks.|Per protocol set (PPS)||Days||95% Confidence Interval|Median
52678|NCT01289821|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of first documented objective response of PR or CR, whichever was noted earlier, to first subsequent disease progression or death (if death occurred before progression was documented). DOR was defined for responders only (that is, subjects with CR or PR). DOR for subjects without disease progression or death before progression was right censored at the date of their last tumor assessment.|From start of treatment of first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks.|Per protocol set (PPS)||Days||95% Confidence Interval|Median
52679|NCT01289821|Secondary|Disease Control (DC)|DC was defined as the proportion of participants who had a best response rating of CR, PR, or stable disease (SD) according to RECIST criteria that was achieved during treatment or within 30 days after termination of study treatment. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. A minimum of 8 weeks (allowing a minus 7-day time window) between start of study treatment and the first follow-up tumor assessment with SD as response was required to assign SD as best overall response.|From start of treatmentof the first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks.|PAS||Proportion of participants|||Number
52680|NCT01289821|Secondary|Progression-free Survival (PFS)|PFS was defined as time from the date of start of study treatment to the date of first observed disease progression (radiological according to central assessment or clinical), or death due to any cause, if death occurred before progression was documented. PFS for participants without disease progression or death at the date of database cutoff were right-censored at the last date of tumor assessment. Participants who had no tumor evaluation after baseline and no clinical progression post baseline and who did not die were censored at Day 1 in the analysis. PD = At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non target lesions or the appearance of one or more new lesions will also constitute PD.|From start of treatment of the first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks.|Full analysis set (FAS)||Days||95% Confidence Interval|Median
52681|NCT01289821|Secondary|Overall Survival (OS)|OS was calculated as the time from first date of receiving study treatment to date of death due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of first participant until database cut-off approximately 13 months later (7 FEB 2011 - 5 MAR 2012). Assessed every 8 weeks.|Full analysis set (FAS)||Days||95% Confidence Interval|Median
52682|NCT01289821|Primary|Objective Response (OR)|OR was defined as the best tumor response (confirmed complete response [CR] or partial response [PR]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions.|From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.|Primary analysis set (PAS)||Proportion of participants|||Number
52683|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) in Work Productivity and Activity (WPAI) Absenteeism Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Time missed from work in hours because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work, question #2). The number of hours missed from work because of HCV was divided by the total number of hours supposed to work, and expressed as a percentage. An area under the curve (AUC) analysis compared the WPAI absenteeism scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms WPAI absenteeism scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI absenteeism scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|Analysis Population Description: The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52684|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. Scores ranged from 0 (no effect on activities) to 10 (completely prevented me from doing my daily activities). An area under the curve (AUC) analysis compared the impairment in daily activity scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in impairment in daily activity scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in the impairment in daily activity scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52685|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants during study visits throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). An area under the curve (AUC) analysis compared the overall WPAI Overall Work Productivity Scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the WPAI Overall Work Productivity Scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI Work Productivity Scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52686|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment began and throughout treatment and follow-up to rate the severity and impact of fatigue they experienced in the preceding 2 weeks on their daily lives. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst possible fatigue]. An area under the curve (AUC) analysis compared the overall severity of fatigue in each treatment group from baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the amount of fatigue participants experienced throughout the study resulting in equal AUC from baseline to Week 72 (AUC72) for FSS total scores. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
52687|NCT01289782|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) values for the CL of TMC435.To calculate the mean CL for all participants in the study, CL values were first derived for each participant at each visit and then a median CL value calculated across visits for each participant. The median CL value for each participant was used to calculate the mean CL for all participants in the study.|Across Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||L/h||Standard Deviation|Mean
52688|NCT01289782|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) values for the C0h of TMC435.To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then a median C0H value calculated across visits for each participant. The median COh value for each participant across all visits was used to calculate the mean C0h for the study.|Before administration of TMC435 at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng/mL||Standard Deviation|Mean
52689|NCT01289782|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 for all participants. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then a median AUC value calcuated across all visits for each participant. The median AUC value across all visits for each participant was used to calculate the mean AUC 24 hr all participants in the study.|Fom the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng*h/mL||Standard Deviation|Mean
52690|NCT01289782|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Weeks||95% Confidence Interval|Median
52691|NCT01289782|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 158 of 264 participants in the TMC435 treatment group and 89 of 130 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication).||Percentage of participants|||Number
52692|NCT01289782|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||Standard Error|Mean
52693|NCT01289782|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52697|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
52698|NCT01289782|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52699|NCT01289782|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52700|NCT01289782|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52701|NCT01289782|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52702|NCT01289782|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as greater than or equal to 2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52703|NCT01289782|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52704|NCT01289782|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52705|NCT01289782|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52706|NCT01289782|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52707|NCT01289782|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52708|NCT01289782|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52709|NCT01289782|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52727|NCT01289548|Secondary|Plasma Concentration of SOD in the Recipients|Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within 24hours after the operation|All patients completed the trial and no dropout occured.||U/ml||Inter-Quartile Range|Median
52710|NCT01289782|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, < 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52711|NCT01289782|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
52712|NCT01289782|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows the change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
52713|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52714|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52715|NCT01289782|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52716|NCT01289782|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
52717|NCT01289639|Secondary|Change in Hepatic Insulin Sensitivity|Hepatic insulin sensitivity was determined using stable glucose isotope measurements during the low dose hyperinsulinemic euglycemic clamp to determine the rate of endogenous glucose production in the fasting state and in response to a low dose glucose infusion. The ability of insulin to suppress glucose, which is mainly produced by the liver, thus provides a measure of hepatic insulin sensitivity and is expressed as a percentage of the basal state. Change in the ability of low dose insulin to suppress endogenous glucose production during a labeled hyperinsulinemic euglycemic clamp.|0-6 months|||% change from baseline||Standard Error|Mean
52718|NCT01289639|Secondary|Change in Intra-abdominal Fat Area by CT Scan||0-6 months|||mm2||Standard Error|Mean
52719|NCT01289639|Secondary|Change in Peripheral Insulin Sensitivity|Change in the rate of glucose disposal (Rd) during the low dose clamp. During a clamp procedure, insulin is infused at a dose based on body size and a glucose solution is infused and the rate adjusted every 5 minutes based on a blood glucose reading to maintain the blood glucose stable at 90 mg/dl (normal level). Using glucose isotopes and the rate of the glucose infusion, we are then able to calculate how much glucose the liver is producing and how much glucose is being taken up into tissues. This provides a measure of insulin sensitivity.|0-6 months|||mg/minute/kg lean mass||Standard Error|Mean
52720|NCT01289639|Secondary|Change in Liver/Spleen Ratio Measure by the Density Ratio in Hounsfield Units Between the Liver and the Spleen by CT||0-6 months|||ratio||Standard Error|Mean
52721|NCT01289639|Secondary|Change in Alanine Aminotransferase (ALT) Levels||0-6 months|||U/L||Standard Error|Mean
52722|NCT01289639|Primary|Liver/Spleen Ratio Measured as the Ratio in Hounsfield Units Between the Liver and the Spleen on Computed Tomography (CT) Scan||6 months|||ratio||Standard Error|Mean
52723|NCT01289574|Secondary|Percent Change in Noninflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized subjects||Percentage change from baseline||Standard Deviation|Mean
52724|NCT01289574|Secondary|Success on Investigator Global Assessment (IGA) at Week 12|"Overall acne rated as clear, almost clear, mild, moderate, severe, very severe.~Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline"|12 weeks|All randomized subjects||Percentage of subjects|||Number
52725|NCT01289574|Primary|Percent Change in Inflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized patients||Percentage change from baseline||Standard Deviation|Mean
52726|NCT01289548|Secondary|Plasma Concentration of MDA in the Recipients|Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the operation|All patients completed the trial and no dropout occured.||nmol/ml||Inter-Quartile Range|Median
52730|NCT01289548|Secondary|Urine Concentration of NAG Postoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.||U/L||Inter-Quartile Range|Median
52731|NCT01289548|Secondary|Urine Concentration of NAG Preoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation|before operation|Urine could not be obtained from the other 46 patients because of anuria.||U/L||Standard Deviation|Mean
52732|NCT01289548|Secondary|Total Costs During the Hospitalization|Total costs from the admission to the discharge of the recipients|from the admission to the discharge of the patients|All the patients completed the study and no dropout occured.||RMB yuan||Inter-Quartile Range|Median
52733|NCT01289548|Primary|Plasma Concentration of NGAL in the Recipients|Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping|within the first 24hours after the operation|All patients completed the trial and no dropout occured.||ng/ml||Inter-Quartile Range|Median
52734|NCT01289548|Primary|Urinary Output of the Recipients Postoperatively|Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation|within the first 3days after the operation|All patients completed the trial and no dropout occured.||ml||Inter-Quartile Range|Median
52735|NCT01289548|Secondary|Length of Postoperative Hospital Stay|time from the day of operation to the day of discharge for the recipients|before discharge|All the patients completed the study and no dropout occured.||day||Inter-Quartile Range|Median
52736|NCT01289548|Secondary|Delayed Graft Function|Delayed Graft Function according to the clinical symptoms|before discharge|All the patients completed the study and no dropout occured.||participants|||Number
52737|NCT01289548|Secondary|Acute Rejection of Transplanted Kidney|biopsy-confirmed, clinically symptomatic|before discharge|All the patients completed the study and no dropout occured.||participants|||Number
52738|NCT01289548|Primary|Plasma Creatine Concentration of the Recipients|Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping|within the first 3days after the operation|All patients completed the trial and no dropout occured.||μmol/l||Inter-Quartile Range|Median
52739|NCT01289418|Primary|the Occurrence of Serious Adverse Events (SAE)||6 months|||participants|||Number
52740|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8, 15 and 29|||participants|||Number
52741|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.||at day 8, 15 and 29|||participants|||Number
52742|NCT01289392|Primary|Sleep Apnea|Number of events per hour of sleep|6 months|||number of events||Standard Deviation|Mean
52743|NCT01289392|Secondary|Inflammatory Markers|Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8|6 months after the basal evaluation||||||
52744|NCT01289392|Primary|Objective Sleep Parameters|Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation|6 months after the basal evaluation||||||
52745|NCT01289210|Secondary|Assess the Safety and Feasibility of the Combination Regimen.||Safety assessed throughout study period.||||||
52746|NCT01289210|Primary|Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.|Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.|Tumor assessment conducted at 12 weeks and every 3-6 months thereafter|Subjects who completed the first 4 weeks of treatment (radiation + 3 VTX-2337 injections) were evaluable for tumor response and immune response. The study was closed due to slow accrual. 2 subjects were enrolled; 1 was evaluable for the primary endpoint, the other discontinued prematurely and was evaluated for safety only (a secondary endpoint).||participants|||Number
52747|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥2.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
52748|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
52749|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
52750|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥ 0.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
52751|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
52752|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.0% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
52753|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤6.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage of participants|||Number
52754|NCT01289119|Secondary|Change From Baseline in Body Weight|The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy.|Baseline and Weeks 8 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline weight assessment. Last observation carried forward was utilized.||kg||Standard Error|Least Squares Mean
52755|NCT01289119|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).|Randomization to Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline assessment.||percentage of participants|||Number
52756|NCT01289119|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8, 12 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline FPG assessment. Last observation carried forward was utilized.||mmol/L||Standard Error|Least Squares Mean
52757|NCT01289119|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8 and 12.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
52758|NCT01289119|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
52759|NCT01289080|Secondary|The Abnormalities Found in Vital Signs, ECGs, and Clinical Laboratory Tests Are Reported as AEs Upon Study Physicians Discretion.|An adverse event (AE) was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.|AEs were recorded from Screening (ICF was signed) to Follow-up 31 (+ 2) days.|The dataset for all safety analyses consisted of the data from all enrolled participants who received at least 1 dose of study medication, regardless of any protocol deviation. All observed data for these subjects were included.||participants|||Number
52760|NCT01289080|Secondary|Fraction of the Systemically Available Brexpiprazole Metabolite (DM-3411) Excreted Into the Urine (fe,u).|Urine samples were collected at Predose and at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||% of unbound brexpiprazole in urine.||Standard Deviation|Mean
52761|NCT01289080|Secondary|Renal Clearance (CLr) of Brexipiprazole Metabolite (DM-3411).|Urine samples were collected at Predose at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
52774|NCT01289041|Secondary|Progression Free Survival (PFS) According to PI3K Activation Pathway Status|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.|24 months|Full analysis set includes all patients who received at least one dose of study drug.||months||95% Confidence Interval|Median
52762|NCT01289080|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. The terminal phase elimination half-life was not determined for DM-3411 metabolite.||h||Standard Deviation|Mean
52763|NCT01289080|Secondary|Apparent Unbound Clearance From Plasma After Extravascular Administration of Brexpiprazole (CLu/F).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
52764|NCT01289080|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||% of unbound brexpiprazole in plasma||Standard Deviation|Mean
52765|NCT01289080|Secondary|Apparent Clearance From Plasma After Extravascular Administration of Brexpiprazole (CL/F).|The value of CL/F was determined as Dose/AUC∞. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||mL/h/kg||Standard Deviation|Mean
52766|NCT01289080|Secondary|Time to Cmax of Brexiprazole Metabolite (DM-3411) (Tmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||h||Full Range|Median
52767|NCT01289080|Secondary|Maximum Plasma Concentration of Brexpiprazole Metabolite (DM-3411) (Cmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
52768|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUC∞ was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. AUC-time curve from zero to infinity (AUC∞) was not determined for DM-3411 metabolite.||ng*h/mL||Standard Deviation|Mean
52769|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole Metabolite (DM-3411) Calculated to the Last Observable Concentration at Time t (AUCt).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUCt was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
52770|NCT01289080|Primary|Unbound Maximum (Peak) Plasma Concentration of Brexpiprazole (Cmax,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng/mL||Standard Deviation|Mean
52771|NCT01289080|Primary|Unbound Area Under AUC- Time Curve From Time Zero to Infinity (AUC∞,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||ng*h/mL||Standard Deviation|Mean
52772|NCT01289080|Primary|Unbound Area Under the Concentration (AUC) Time Curve Calculated to the Last Observable Concentration Brexpiprazole (AUCt,u).|Blood samples were collected on Day 1 at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours Postdose or at Early Termination (ET). Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for pharmacokinetics (PK) analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.||nanograms*hours/mL (ng*h/mL)||Standard Deviation|Mean
52773|NCT01289041|Secondary|Overall Survival (OS) According to PI3K Activation Pathway Status|Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.|every 3 months|Full analysis set includes all patients who received at least one dose of study drug.||months||95% Confidence Interval|Median
52775|NCT01289041|Primary|Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status|"BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines.~BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR od SD >= 24 weeks)"|24 months|Full analysis set includes all patients who received at least one dose of study drug.||number of participants|||Number
52776|NCT01289028|Secondary|Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.|Progression-free survival (PFS) is defined as the time from first study drug administration to objective tumor progression or death from any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.|during 12 months|||days||95% Confidence Interval|Median
52777|NCT01289028|Secondary|Overall Survival, Number of Events Related to Progression of the Disease|The OS rate could not be calculated due to the high number of censored cases. Number of censored, n (%) 108 (86.4). Only available data is number of events. OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died, survival was censored at date of last contact.|during 12 months|||events|||Number
52778|NCT01289028|Secondary|Duration of Overall Response|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence|during 12 months|||days||95% Confidence Interval|Median
52779|NCT01289028|Secondary|Time to Tumor Progression|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated as stated in section 9.8.3 of the clinical study report.|during the first 4 months|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated|||||
52780|NCT01289028|Secondary|Time to Overall Response (CR or PR): Per Protocol Population|Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks|||percentage of participants|||Number
52781|NCT01289028|Secondary|Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population|Complete Response (CR): Disappearance of all target lesions. and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks|ITT population||percentage of participants|||Number
52782|NCT01289028|Primary|Percent of Patients Achieving Complete Response (CR)|Complete response (CR) is the Disappearance of all target lesions.|during the first 4 months|||percentage of participants|||Number
52783|NCT01289028|Primary|Percent of Patients Achieving Partial Response (PR)|The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|during the first 4 months|ITT set, N=125||percentage of participants|||Number
52784|NCT01289028|Primary|Percent of Patients Achieving Stable Disease (SD)|Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.|During the first 4 months|||% participants|||Number
52785|NCT01289015|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).~Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6.|Full Analysis Set (FAS) using a Modified Intent to Treat population.||percentage of subjects|||Number
52786|NCT01289015|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.~Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because culture results were not available before the start of treatment.||percentage of subjects|||Number
52787|NCT01288911|Secondary|Percentage of Participants With Adverse Events|"A serious adverse event was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life threatening~Resulted in persistent or significant disability/incapacity~Resulted in congenital anomaly or birth defect~Required inpatient hospitalization or led to prolongation of hospitalization~Other medically important events.~Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment."|From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)||percentage of participants|||Number
52788|NCT01288911|Secondary|Percentage of Participants With an Objective Response|"Response assessments were reported by ICR for target lesions in soft tissues and non-target lesions in soft tissues based on CT and/or MRI according to RECIST version 1.1.~Objective response was defined as the number of participants achieving either a complete response (CR) or a partial response (PR) based on participant’s best overall response assessed at the end of the treatment."|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||percentage of participants|||Number
52814|NCT01288612|Secondary|Rate of Complete Evaluation|The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||procedures|||Number
52789|NCT01288911|Secondary|Radiographic PFS Based on ICR Assessment|"Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression.~Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan."|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
52790|NCT01288911|Secondary|Time to ≥ 90% PSA Decline From Baseline|The time to ≥ 90% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 90% was recorded. In participants without ≥ 90% PSA decline from Baseline, the time to ≥ 90% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
52791|NCT01288911|Secondary|Time to ≥ 50% PSA Decline From Baseline|The time to ≥ 50% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 50% was recorded. In participants without ≥ 50% PSA decline from Baseline, the time to ≥ 50% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
52792|NCT01288911|Secondary|Time to ≥ 30% PSA Decline From Baseline|The time to ≥ 30% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 30% was recorded. In participants without ≥ 30% PSA decline from Baseline, the time to ≥ 30% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
52793|NCT01288911|Secondary|Time to PSA ≤ 4 ng/mL|Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
52794|NCT01288911|Secondary|Time to PSA Progression|Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for patients who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
52795|NCT01288911|Secondary|Best Prostate-specific Antigen (PSA) Response|The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.|Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set with available PSA data||percent change||Full Range|Median
52796|NCT01288911|Secondary|Prostate-specific Antigen (PSA) Response by Week 13|The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.|Baseline to Week 13|Full analysis set with available PSA data||percent change||Full Range|Median
52797|NCT01288911|Secondary|PFS Based on Investigator Assessment|"PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.~Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.~A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.~The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set||months||95% Confidence Interval|Median
52952|NCT01286818|Secondary|Half Life (t1/2) of Ramucirumab|t1/2 is the time required for the plasma/serum concentration to decrease 50%.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable t1/2 data at the specified time points.||days||Geometric Coefficient of Variation|Geometric Mean
52798|NCT01288911|Primary|Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment|"PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.~Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.~A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.~The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set (all randomized participants)||months||95% Confidence Interval|Median
52799|NCT01288859|Primary|Amount of Total Fecal Polyphenols|Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.|0 and 24 hours post‐dose.|||nmol||Standard Error|Mean
52800|NCT01288859|Primary|Urinary Excretion of Total Polyphenols|Area Under the Curve (AUC) from 0 to 24h of total polyphenols (sum of parent polyphenols and metabolites)was calculated using a trapezoidal rule applied to the urinary concentration-time curves of compounds.|Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post‐dose.|Basing on power analysis calculation on a previous work||nmol•h/L||Standard Error|Mean
52801|NCT01288859|Primary|Serum Polyphenol Concentrations Over 24h From Food Consumption|Area Under the Curves (AUC) from 0 to 24h of parent polyphenols was calculated using a trapezoidal rule applied to the concentration-time curves of compounds.|0, 0.5, 1, 2, 4, 6, and 24 hours post‐dose|The number of subjects was based on power calculations derived from our previous study. We calculated that, at α = 0.05 with a power of 80%, 8 subjects would allow us to detect a 20% difference in serum and urinary concentrations of parental compounds, glucuronides and phenolic acids.||nmol*h/L||Standard Error|Mean
52802|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurements. 36 hours is defined at the 36 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 36 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
52803|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 12 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
52804|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 3 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
52805|NCT01288781|Secondary|Change in Fluid Balance|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Urine output was recorded by 24 hour urine collection and fluid intake by 24 hour food diaries. Fluid balance was calculated as:~(urine output (L) / fluid intake (L) ) * 100."|Fluid Balance: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||% of fluid intake||Standard Deviation|Mean
52806|NCT01288781|Secondary|Change in Blood Oxygen Saturation|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement.|Blood Oxygen Saturation: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||% oxygen saturation||Standard Deviation|Mean
52807|NCT01288781|Secondary|Change in High Altitude Headache by Visual Analogue Scale|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Outcome measured using visual analogue scale, where 0 mm is no headache and 100 mm is maximum headache.|High Altitude Headache: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
52808|NCT01288781|Primary|Change in Optic Nerve Sheath Diameter by Ultrasonography|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement.~24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure."|Optic Nerve Sheath Diameter: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.||mm||Standard Deviation|Mean
52809|NCT01288612|Secondary|Acceptability|Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||percentage of participants|||Number
52810|NCT01288612|Secondary|Mean Tolerability Scores|Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||units on a scale||Standard Deviation|Mean
52811|NCT01288612|Secondary|Mean Time From Extubation to Discharge|This outcome measures the recovery time after the procedure.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||minutes||Standard Deviation|Mean
52812|NCT01288612|Secondary|Mean Duration of Procedure|Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||minutes||Standard Deviation|Mean
52813|NCT01288612|Secondary|Rate of Acquisition of Biopsies From the Esophagus||Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||percentage of participants|||Number
52815|NCT01288612|Secondary|Rate of Successful Intubation|The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).||percentage of participants|||Number
52816|NCT01288612|Primary|Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment|This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.|Approximately 2 weeks after invitation letter was sent|The analysis population for this outcome measure was the number of subjects per group who were eligible to contact.||percentage of participants|||Number
52817|NCT01288534|Secondary|Frequency of Required Interventions.|To assess the frequency of required interventions based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical.|5 years||10/2016||||
52818|NCT01288534|Secondary|Relation Between Reconstructed Delivered Dose Distributions.|To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.|5 years||10/2016||||
52819|NCT01288534|Secondary|Relation Between Dose Distribution and Toxicities.|To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses.|5 years||10/2016||||
52820|NCT01288534|Secondary|Percentage of Patients With a PSA Nadir of <3.35 ng/ml|To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion.|1 Year||10/2016||||
52821|NCT01288534|Primary|Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)|"To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks.~Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months."|24 months|||percentage of patients|||Number
52822|NCT01288469|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameter analyzed||ratio||Inter-Quartile Range|Median
52823|NCT01288469|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment HDL-C value.||percent change||Standard Error|Least Squares Mean
52824|NCT01288469|Secondary|Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).|From baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.||percent change||Inter-Quartile Range|Median
52825|NCT01288469|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis||Week 8 (LOCF)|mITT population.||percentage of participants|||Number
52826|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.||mg/dL||Standard Error|Least Squares Mean
52827|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.||mmol/L||Standard Error|Least Squares Mean
52828|NCT01288469|Primary|Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 8 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 8 (LOCF)|Modified Intent-To-Treat (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.||percent change||Standard Error|Least Squares Mean
52829|NCT01288443|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for ApoB/ApoA-1 ratio analyzed.||ratio||Standard Error|Least Squares Mean
52830|NCT01288443|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.||percent change||Inter-Quartile Range|Median
52889|NCT01287416|Secondary|Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training|Number of people who endorsed having thought about suicide in the past 2 days as measured immediately post training (not at all vs a little to a lot)|July 22-23, 2010|The smaller number of participants per group reflects the number of individuals who responded to the post-training questionnaire.||participants|||Number
52831|NCT01288443|Secondary|Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies the number of participants analysed for each lipid parameter.||percent change||Standard Error|Least Squares Mean
52832|NCT01288443|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.||percentage of participants|||Number
52833|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mg/dL||Standard Error|Least Squares Mean
52834|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.||mmol/L||Standard Error|Least Squares Mean
52835|NCT01288443|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first study drug injection up to 21 days after last study drug injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.||percent change||Standard Error|Least Squares Mean
52836|NCT01288287|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks|HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks.|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||units on a scale||Standard Deviation|Mean
52837|NCT01288287|Secondary|Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks|"RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.~A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||units on a scale||Standard Deviation|Mean
52838|NCT01288287|Secondary|Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline|"Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(ESR) ≤ 3.2 and decrease from baseline > 0.6 and ≤ 1.2,~DAS28(ESR) > 3.2 and ≤ 5.1 and decrease from baseline > 0.6,~DAS28(ESR) > 5.1 and decrease from baseline > 1.2 Patients without a good or moderate response are considered to be non-responders."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||percentage of patients|||Number
52839|NCT01288287|Secondary|Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:~DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.~DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||units on a scale||Standard Deviation|Mean
52840|NCT01288287|Primary|Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:~DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.~DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).||percentage of patients||95% Confidence Interval|Number
52841|NCT01288209|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|"The table below shows the median (range) AUC24h values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of “Overall” represents the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng.h/mL||Full Range|Median
52842|NCT01288209|Secondary|Plasma Concentrations of TMC435|"The table below shows median (range) TMC435 predose plasma concentration (C0h) values and TMC435 maximum plasma concentration (Cmax) values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of “Overall” representes the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
52843|NCT01288209|Secondary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2a and RBV at Week 24. Participants in the TMC435 treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52844|NCT01288209|Secondary|The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants in each treatment group with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at the EOT. At Baseline, 34/53 participants in the TMC435 100 mg 12 Wks PR 24/48 treatment group and 35/53 participants in the TMC435 100 mg 24 Wks PR 24/48 treatment group had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52845|NCT01288209|Secondary|The Number of Participants Demonstrating Viral Relapse During the Study|The table below shows the number of participants in each treatment group who demonstrated viral relapse during the study. Viral relapse is defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at EOT and detectable HCV RNA during follow-up or detectable HCV RNA at the time points for a sustained viral response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52846|NCT01288209|Secondary|The Number of Participants With Viral Breakthrough During the Study|The table below shows the number of all participants in each treatment group who experienced viral breakthrough during the treatment period in the study (Baseline to end of treatment [EOT], ie, Week 24 or 48). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in all participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable.|Up to EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Participants|||Number
52847|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12|"The table below shows the percentage of participants with undetectable HCV RNA at Weeks 24, 48, end of treatment (EOT), at the time of assessment for a sustained virologic response (SVR) 12 weeks after the last planned dose (SVR12) (Week 36 or 60), and SVR24 (Week 48 or 72) who did not achieve undetectable HCV RNA levels at Week 12. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed. Results are not available for Weeks 24, 48, and EOT because there were no participants who met the criteria for a SVR at those time points."|Weeks 24, 48, EOT (Weeks 24 or 48), SVR12 (Weeks 36 or 60), and SVR24 (Weeks 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52848|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (<1.2 log10 IU/mL) during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52861|NCT01287897|Secondary|Serum PF-04236921 Concentration Over Time||Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40|"The pharmacokinetic (PK) analysis set was the subset of participants from the SAS who provided at least 1 PK concentration (2 participants [10 mg arm] excluded due to a quality issue). n is the number of participants with PK data at the visit. From Weeks 16 to 40, only participants who remained in the follow-up period of this study were analyzed."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
52849|NCT01288209|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group with a greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in HCV RNA at each time point during treatment and post-treatment follow-up.|Day 3, Day 7, and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and Follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52850|NCT01288209|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants in each treatment group with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|EOT (Week 24 or 48) and Week 48 or 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52851|NCT01288209|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants in each treatment group with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (Week 24 or 48) and Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.||Percentage of participants|||Number
52852|NCT01288079|Primary|Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment|A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214, duloxetine or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
52853|NCT01288027|Secondary|Percent Change From Baseline in Disease Activity Using T2 Magnetic Resonance Imaging (MRI) at Week 26|Disease activity (inflammation and/or water content within muscles) was quantitatively assessed by T2 MRI values in a subset of participants. A T2 MRI value of greater than (>) 39 millisecond (ms) was defined as abnormal. T2 estimation normally requires an additional acquisition for computing the B1 spatial deviation however, can still be estimated if this acquisition is missing.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here Number of participants analyzed = number of participants with both baseline and Week 26 assessment of disease activity.||percent change||Standard Deviation|Mean
52854|NCT01288027|Secondary|Percent Change From Baseline in Degree of Fatty Infiltration Using 3-Point 3-Dimensional (3D) Dixon at Week 26|Degree of Fatty Infiltration was assessed by 3-point 3D Dixon acquisition using skeletal muscle MRI in a subset of participants.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, number of participants analyzed = number of participants with both Baseline and Week 26 assessment of degree of fatty infiltration.||percent change||Standard Deviation|Mean
52855|NCT01288027|Secondary|Percent Change From Baseline in Muscle Involvement Using Mercuri Scoring at Week 26|Muscle involvement was assessed by T1-weighted magnetic resonance imaging (MRI). T1-weighted MRI data was analyzed using the Mercuri scoring in both legs (Total score = 1-4; where 1=Normal appearance, 2=Mild involvement, 3=Moderate involvement, and 4=Severe involvement). For each participants, the average for each the upper (thigh) and lower leg was computed for Mercuri grading.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, Number of participants analyzed= participants with both Baseline and Week 26 assessment of muscle involvement, n= number of participants with both Baseline and Week 26 assessment of muscle involvement for specified category.||percent change||Standard Deviation|Mean
52856|NCT01288027|Secondary|Lysosomal Inclusions||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.|||||
52857|NCT01288027|Secondary|Muscle Fiber Morphology||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.|||||
52858|NCT01288027|Secondary|Glycogen Distribution||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.|||||
52859|NCT01288027|Primary|Change From Baseline in Tissue Glycogen Content in Quadriceps Muscle Biopsy Samples at Week 26|Tissue glycogen content was measured by quadriceps biopsies as ‘percent area of tissue occupied by glycogen'.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, n = number of participants with both Baseline and Week 26 assessment of tissue glycogen content.||percent area occupied by glycogen||Standard Deviation|Mean
52860|NCT01287897|Secondary|Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."||participants|||Number
52862|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)|The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."||percentage of participants|||Number
52863|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)|The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."||percentage of participants|||Number
52864|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||points on a scale||90% Confidence Interval|Least Squares Mean
52865|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||points on a scale||90% Confidence Interval|Least Squares Mean
52866|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
52867|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
52868|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
52869|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
52870|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
52871|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."||Percentage of participants||90% Confidence Interval|Least Squares Mean
52872|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.|Baseline and Week 12|The analysis was performed on FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.||Percentage of participants||90% Confidence Interval|Least Squares Mean
52873|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 12|Primary analysis: FAS excluding 200 mg arm (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).||Percentage of participants||90% Confidence Interval|Least Squares Mean
52886|NCT01287416|Secondary|Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts|Number of participants who have asked someone that they thought was at risk about suicidal thoughts since the training, measured at 6 month follow-up assessment.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||participants|||Number
52887|NCT01287416|Secondary|Attempted Suicide Since Training at 6 mo Follow-up|Number of people who endorsed having made a suicide attempt since the training as measured at 6 month follow-up|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.||participants|||Number
52888|NCT01287416|Secondary|Suicidal Ideation Since Training at 6 mo Follow-up|Number of people who endorsed having thought about suicide since the training as measured at 6 month follow-up (not at all vs a little to a lot)|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.||participants|||Number
52874|NCT01287897|Primary|The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.|Baseline and Week 8|The analysis was performed on FAS participants of the 200 mg and placebo arms, referred to as FAS 200 mg versus (vs) placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.||Percentage of participants||90% Confidence Interval|Least Squares Mean
52875|NCT01287897|Primary|The Crohn’s Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 8|Primary analysis: full analysis set (FAS, defined as all randomized participants who received at least 1 dose of study treatment; 2 participants [10 mg arm] excluded due to a quality issue) excluding 200 mg (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).||Percentage of participants||90% Confidence Interval|Least Squares Mean
52876|NCT01287832|Secondary|Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity||30-42 days post-treatment||||||
52877|NCT01287832|Primary|Number of Participants With Clinical Success at Test of Cure Visit.|Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.|30-42 days post-treatment|||participants|||Number
52878|NCT01287754|Secondary|Percentage of Participants With EGFR Mutation at Screening|Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.|Screening|All Participants Enrolled||percentage of participants||95% Confidence Interval|Number
52879|NCT01287754|Secondary|Percentage of Participants Alive at 6 and 12 Months|Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.|At 6 and 12 months|All Participants Enrolled||percentage of participants|||Number
52880|NCT01287754|Secondary|Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants|OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Enrolled: All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated participants, were included in the analysis.||months||95% Confidence Interval|Median
52881|NCT01287754|Secondary|Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1|Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated||participants|||Number
52882|NCT01287754|Primary|Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation|PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated: All participants who received at least one dose of erlotinib were included in the analysis.||months||95% Confidence Interval|Median
52883|NCT01287611|Secondary|Length of Uterine Incision After Suturing|Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.|6 weeks after C/S|||cm||Standard Deviation|Mean
52884|NCT01287611|Primary|Cesarean Scar Defect in the Uterine Incisional Line|A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.|6 weeks after C/S|||participants|||Number
52885|NCT01287416|Secondary|Gatekeeper Behaviours - Did Not Ask Person at Risk|Number of participants who did not ask someone about their suicidal thoughts even though they thought they were at risk, measured at 6 month follow-up assessment based on time since training.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||participants|||Number
52893|NCT01287416|Secondary|Self-reported Resiliency Score|Assesses resiliency in the participant according to the Connor-Davidson Resilience Scale, 10-item. The CD-RISC 10 is comprised of ten questions scored from 0 (Not at all true) to 4 (True nearly all of the time). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (low resiliency) to 40 (highly resilient).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||Scores on scale||Standard Error|Mean
52894|NCT01287416|Secondary|Self-reported Alcohol Use|Details participants' level of alcohol consumption and if it may be harmful according to the AUDIT. The AUDIT scale is comprised of ten questions with most questions being scored from 0 (never) to 4 (4 or more times per week). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (no risk related to alcohol) to 40 (high risk related to alcohol). Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||Scores on a scale||Standard Error|Mean
52895|NCT01287416|Secondary|Self-reported Distress|Measures the level of distress in the participant using the K6 distress scale. The scale is comprised of six questions which are scored from 0 (none of the time) to 4 (all of the time). The sum of the scores from all six questions was used to determine a total scale score which ranges from 0 (not at all distressed) to 24 (very distressed).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.||Scores on a scale||Standard Error|Mean
52896|NCT01287416|Secondary|Self-perceived Preparedness|Measures the level of preparedness of the individual to help someone who is suicidal based on a 4 point Likert scale ranging from 1 (not at all prepared) to 4 (very prepared).|pre-training, post-training and 6 month follow-up|||Scores on a scale||Standard Deviation|Mean
52897|NCT01287416|Secondary|Self-perceived Knowledge About Suicide|Measures the level of knowledge about suicide that the individual believes they have based on a 4 point Likert scale ranging from 1 (not at all knowledgeable) to 4 (very knowledgeable).|pre-training, post-training and 6 month follow-up|||Scores on a scale||Standard Deviation|Mean
52898|NCT01287416|Secondary|Self-perceived Skill in Helping a Suicidal Individual|Measures the level of ability that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all skilled) to 4 (very skilled).|pre-training, post-training and 6 month follow-up|||scores on a scale||Standard Deviation|Mean
52899|NCT01287416|Secondary|Self-perceived Confidence in Helping a Suicidal Individual|Meaures the level of confidence that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all confident) to 4 (very confident).|pre-training, post-training and 6 month follow-up|||scores on a scale||Standard Deviation|Mean
52900|NCT01287416|Primary|SIRI Questionnaire Score|The Suicide Intervention Response Inventory (SIRI-2) will be used to detect enhancement of intervention skills in participants. The 25-item SIRI-2 is a self-administered test that was designed to measure competnce in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI-2 has shown its good psychometric properties, freedom from social desirabiity effects and responsiveness to training in suicide prevention.|pre-training, post-training and 6 mo follow up|||number of items correct||Standard Deviation|Mean
52901|NCT01287403|Secondary|Phenolic Acids|Phenolic acids in plasma and urine|0-48 h post dose||||||
52902|NCT01287403|Secondary|Plasma and Urinary Betaine||From 0 to 48 hours post dose||||||
52903|NCT01287403|Primary|Plasma Alkylresorcinol Compounds|Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.|From 0 to 48 h post dose.|||nmol/L*h||Standard Deviation|Mean
52904|NCT01287364|Primary|Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales|Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables “correlates” with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors.|Day 1 (Pre-treatment) through Day 29|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.||factor loadings|||Number
52905|NCT01287364|Primary|Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)|"Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are “small”(0.2), “medium” (0.5), and “large” (0.8).~Between group SES indicates the magnitude of “treatment” differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)."|Day 1 (Pre-treatment) through Day 29|Baseline rTNSS was partitioned into tertiles and patients were assigned to Low, Medium, or High symptom groups.||standard effect sizes|||Number
52913|NCT01287221|Secondary|Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II)|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
52906|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of “no change” (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (pre-treatment) through Day 7 Treatment Period 2|The rTNSS total period 2 change scores were partitioned into tertile ranges to form three groups: Low Change (-0.70 – -1.85; n = 55), Medium Change (-2.08 – -1.74; n = 56), or High Change (-6.57 – -2.14; n = 55).||scores on a scale||Standard Error|Mean
52907|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of “no change” (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (pre-treatment) through Day 7 Treatment Period 1|The rTNSS total period 1 change scores were partitioned into tertile ranges to form three groups: Low Change (-1.04 – -4.93; n = 60), Medium Change (-2.49 – -1.05; n = 62), and High Change (-7.57 – -2.50; n = 61).||scores on a scale||Standard Error|Mean
52908|NCT01287364|Primary|Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)|Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 – 7.17; n = 62), Medium Symptoms (7.25 – 9.25; n = 61), or High Symptoms (9.33 – 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (Pre-treatment) through Day 7 Treatment Period 1|Baseline rTNSS was partitioned into tertile ranges and patients were assigned to Low (3.00 – 7.17; n = 62), Medium (7.25 – 9.25; n = 61), or High (9.33 – 12.00; n = 62) symptom groups.||scores on a scale||Standard Error|Mean
52909|NCT01287364|Primary|Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics|Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses [Cronbach’s alpha (raw and standardized) coefficients were calculated]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.|Day 1 (Pre-treatment) through Day 7 Treatment Period 2|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.||ratio of variance|||Number
52910|NCT01287221|Secondary|Change in the COMPASS-Select-Change Scale From Baseline to 12 Months|"The change in COMPASS is a derivative of COMPASS and evaluates the change in symptoms over time on selected domains of symptoms as a function of natural history or intervention therapy. The focus is on 7 selected domains. The version of the COMPASS-Change -Select Scale used (06-09-2009 Ver. 1) has 16 questions, with multiple parts, scores ranging from much worse to no such symptoms. The score could range from 0 (no such symptoms) to 94 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
52911|NCT01287221|Secondary|Change From Baseline to 12 Months in the COMPASS-Select Scale|"The composite autonomic symptoms score (COMPASS) provides a score of autonomic symptom severity with appropriate weighting. In the COMPASS_select, symptoms are confined to 6 select domains of symptoms. The version of the COMPASS-Select used (06-09-2009 v1) has 46 questions, with multiple parts, scores ranging from much worse to no such symptoms. Scores could range from 0 (no such symptoms) to 85 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
52912|NCT01287221|Secondary|Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).~Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their total UMSARS scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale per month||Standard Deviation|Mean
52914|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part II|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part II could range from 0 (normal) to 56 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
52915|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11)|UMSARS is a scale measuring disease progression that comprises 4 parts, only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.||units on a scale||Standard Deviation|Mean
52916|NCT01287221|Primary|Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11)|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).~Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their UMSARS I scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles and no imputations were done for any missing values or slope estimates. All randomized participants who took at least two doses of the study drug were included in the principal efficacy analysis. One subject on the Rifampicin arm did not return after the baseline visit.||units on a scale per month||Standard Deviation|Mean
52917|NCT01287208|Secondary|Hours of Sleep Per Night|Number of hours slept per night as recorded on activity device|12 weeks||||||
52918|NCT01287208|Secondary|Weight||12 weeks||||||
52919|NCT01287208|Secondary|Calories Burned Per Day|Total calories burned per day recorded on activity device|12 weeks||||||
52920|NCT01287208|Secondary|Distance Per Day|Distance in miles recorded on activity device|12 weeks||||||
52921|NCT01287208|Primary|Steps Per Day|Steps will be recorded on the activity device|12 weeks|We excluded 4 participants who withdrew prior to randomization and 5 who withdrew after randomization.||steps per day||Inter-Quartile Range|Median
52922|NCT01287117|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
52923|NCT01287117|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded “No” to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage||Standard Deviation|Mean
52924|NCT01287117|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
52925|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
52926|NCT01287117|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
52927|NCT01287117|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
52928|NCT01287117|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Weeks||95% Confidence Interval|Median
52929|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
52930|NCT01287117|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
52931|NCT01287117|Primary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
52932|NCT01287065|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN) and total bilirubin >=2 x ULN or international normalised ratio >1.5. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)|All Subjects Population: all participants who received at least one dose of the study medication.||Participants|||Number
52933|NCT01287065|Secondary|AM and PM Pre-treatment Trough FEV1 on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Trough FEV1 is defined as pre-dose (AM and PM) FEV1 measurement taken on Day 14. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant baseline, period baseline, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=23).|Day 14|ITT Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
52934|NCT01287065|Secondary|Pre-treatment PEF (AM and PM) on Days 1-12.|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 2 to 12 was analyzed. The analysis was performed using a mixed effect analysis of covariance model with fixed effect terms for treatment and period; baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=26). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=24).|From Day 2 up to Day 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||95% Confidence Interval|Least Squares Mean
52935|NCT01287065|Primary|Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0–24 Hours Post-dose on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at the following time points: pre-dose (Day 14 evening dose), and 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant (par.) baseline, period baseline, gender and age fitted as covariates; and par. as a random effect. Par. 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Par. 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=20).|Pre-dose on Day 14 to 24 hours post-dose|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication and provided at least one post-dose peak expiratory flow (PEF) or FEV1 measurement. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
52936|NCT01287039|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|The immunogenicity of reslizumab was assessed by measuring for the presence of anti-reslizumab antibodies at baseline, weeks 16, 32, 48, and 52 or early withdrawal. Blood samples for anti-reslizumab antibodies assessment were also obtained from all patients (inside or outside of the US) experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.|Weeks 16, 32, 48 and 52|Safety analysis set. Immunogenicity for anti-reslizumab antibodies not reported for the placebo treatment arm.||participants|||Number
52937|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse - high 12-17 yr: >100 and increase of >= 30 beats/minute (bpm)~Sitting pulse - low >=18 yr: <50 and decrease of >=30 bpm~Sitting pulse - high >=18 yr: >100 and increase of >=30 bpm~Sitting systolic blood pressure - low >=18 yr: <90 and decrease of >=30 mmHg~Sitting systolic blood pressure - high >=18 yr: >160 and increase of >=30 mmHg~Sitting diastolic blood pressure - low 12-17 yr: <55 and decrease of >=12 mmHg~Sitting diastolic blood pressure - low >=18 yr: <50 and decrease of >=12 mmHg~Sitting diastolic blood pressure - high >=18 yr: >100 and increase of >=12 mmHg~Respiratory rate >=18 yr: >24 and increase of >=10 breaths/minute~Body temperature - low 12-17 yr: <96.5° Fahrenheit or <35.8° Celsius~Body temp - low >=18 yr: <96.5° F or <35.8° C~Body temp - high >=18 yr: >100.5° Fahrenheit"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set||participants|||Number
52938|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 5-49 U/L.~Bilirubin: >=34.2 μmol/L~White blood cells: <=3.0 or >20 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Neutrophils: <=1.0 10^9/L~Eosinophils: >10.0 %~Platelets: <75 or >=700 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set||participants|||Number
52939|NCT01287039|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Week 52|Randomized set||CAEs in 52 weeks||95% Confidence Interval|Mean
52940|NCT01287039|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set||participants|||Number
52941|NCT01287039|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.~The during treatment average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set of participants with assessments within timeframe||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
52942|NCT01287039|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (Weeks 4, 8, 12 and 16) SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set of participants with assessments within the timeframe||puffs/day||Standard Error|Least Squares Mean
52943|NCT01287039|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.~The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
52983|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 1|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.|Week 1|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 1 were analyzed.||ng/mL||Standard Deviation|Mean
52944|NCT01287039|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 478 (longest treatment time plus 2 weeks)|Randomized set||weeks||95% Confidence Interval|Median
52945|NCT01287039|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
52946|NCT01287039|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were “patient-specific,” which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of patients with assessments at both timepoints||units on a scale||Standard Error|Least Squares Mean
52947|NCT01287039|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Positive change from baseline scores indicate improvement in asthma control.~The during treatment (Weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set, including participants who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
52948|NCT01287039|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.~Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Week 52|Randomized set||CAEs in 52 weeks||95% Confidence Interval|Mean
52949|NCT01286818|Secondary|Best Overall Response [Anti-Tumor Activity of FOLFIRI Plus Ramucirumab (IMC-1121B)]|Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Every 8 weeks until PD (up to 49 weeks)|Safety population: Participants who received any quantity of study medication.||participants|||Number
52950|NCT01286818|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab|Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Vss data at the specified time points.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
52951|NCT01286818|Secondary|Clearance (CL) of Ramucirumab|The total body CL of ramucirumab on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered CL at steady state (CLss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable CL data at the specified time points.||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
52984|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.|Week 48|Full Analysis Set||percentage of participants|||Number
52953|NCT01286818|Secondary|Area Under the Curve (AUC) of Ramucirumab|Reported for Day 1, Cycle 1 is AUC from time 0 extrapolated to infinity [AUC(0-inf)] and for Day 1, Cycle 5 is AUC over the dosing interval at steady state AUC(tau,ss).|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable AUC data at the specified time points.||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
52954|NCT01286818|Secondary|Maximum Concentration (Cmax) of Ramucirumab|The Cmax of ramucirumab in serum on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered Cmax at steady state (Cmax,ss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Cmax data at the specified time points.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
52955|NCT01286818|Secondary|Number of Participants With Serum Anti-IMC-1121B Antibodies (Immunogenicity)||Day 1 of Cycle 5 (Week 9), Cycle 6 (Week 11), Cycle 7 (Week 13), and Cycle 9 (Week 17) [(1 cycle=14 days)]|Participants who received any quantity of study medication and had evaluable immunogenicity data at the specified time points.||participants|||Number
52956|NCT01286818|Primary|Number of Participants With Ramucirumab Drug-Related Adverse Events or Serious Adverse Events|Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. Events related to Irinotecan, Levofolinate, and 5-fluorouracil (5-FU) were reported separately. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline to end of study (up to 49.3 weeks) plus 37 day follow-up|Safety population: Participants who received any quantity of study medication.||participants|||Number
52957|NCT01286818|Primary|Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period|DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03): Grade 4 neutropenia ≥7 days or ≥Grade 3 with bacteremia or sepsis; Absolute neutrophil count <1.0x10^9/Liters with fever ≥38.3°Celsius requiring intravenous antibiotic therapy; Grade 4 thrombocytopenia or ≥Grade 3 with bleeding requiring platelet transfusion; ≥Grade 3 altered coagulation tests and no anticoagulation; ≥Grade 4 or uncontrolled hypertension; ≥Grade 3 non-hematologic toxicity (except non-clinically significant Grade 3 events like electrolyte abnormality, hypersensitivity, and arthralgia/myalgia); urine protein >3 grams/24 hours; study drug-related toxicity causing Cycle 3, Day 1 treatment delay until Day 44 or later. Grade 3 or Grade 4 infusion-related reaction (hypersensitivity) due to ramucirumab or FOLFIRI, not a DLT.|Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days)|DLT population: All enrolled participants who either completed the first 3 administrations of study medication or discontinued study medication due to a DLT during the DLT assessment period (Day 1, Cycle 1 through Day 1, Cycle 3).||participants|||Number
52958|NCT01286805|Secondary|Quality of Recovery (QoR-40) Physical Comfort Dimension|Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome|First 24 hours after surgery|||QoR-40 Physical Comfort score||Standard Deviation|Mean
52959|NCT01286805|Secondary|Patient Satisfaction|Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)|First 24 hours after surgery|||units on a scale||Standard Deviation|Mean
52960|NCT01286805|Secondary|Requirement of Antiemetic Rescue|The number of participants who needed medication to treat their nausea and vomiting.|Day of surgery prior to discharge|||participants|||Number
52961|NCT01286805|Secondary|Incidence of Vomiting|The number of participants who vomited.|Day of surgery prior to discharge|||participants|||Number
52962|NCT01286805|Secondary|Incidence of Nausea|The number of participants with nausea.|Day of surgery prior to discharge|||participants|||Number
52963|NCT01286805|Secondary|Narcotic Pain Medication Needed||Day of surgery prior to discharge|||equivalents milligrams oral morphine||Standard Deviation|Mean
52964|NCT01286805|Secondary|Readiness to Discharge From Post-Anesthesia Care Unit (PACU)|Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.|Day of surgery prior to discharge|||minutes||Standard Deviation|Mean
52965|NCT01286805|Primary|Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge|The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.|Day of surgery prior to discharge|||units on a scale||Standard Deviation|Mean
52966|NCT01286753|Secondary|Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the drug or biologic concentration in the body following administration.|Up to approximately 4 years|Data were not collected for this outcome.|||||
52967|NCT01286753|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)|Safety population, defined as enrolled participants who received at least one dose of study treatment.||percentage of participants|||Number
52968|NCT01286753|Secondary|Overall Survival|Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment.|From the date of first treatment to the date of death for any cause (up to approximately 4 years)|Intent-to-Treat population, defined as all enrolled participants.||months||95% Confidence Interval|Median
52985|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set||percentage of participants|||Number
52969|NCT01286753|Secondary|Progression-Free Survival|Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the day of first treatment until the first documented PD or death (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||months||95% Confidence Interval|Median
52970|NCT01286753|Secondary|Duration of Response|Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||months||95% Confidence Interval|Median
52971|NCT01286753|Secondary|Clinical Benefit Rate|Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||percentage of participants||95% Confidence Interval|Number
52972|NCT01286753|Secondary|Best Overall Response Rate in TKI-Experienced Participants|Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Experienced group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||percentage of participants||95% Confidence Interval|Number
52973|NCT01286753|Primary|Best Overall Response Rate in TKI-Naive Participants|Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Naive group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.||percentage of participants||95% Confidence Interval|Number
52974|NCT01286740|Secondary|Plasma Concentration of RPV at Week 48|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.|Week 48|Participants with evaluable measurements for plasma concentration of RPV at Week 48 were analyzed.||ng/mL||Standard Deviation|Mean
52975|NCT01286740|Secondary|Plasma Concentration of RPV at Week 36|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.|Week 36|Participants with evaluable measurements for plasma concentration of RPV at Week 36 were analyzed.||ng/mL||Standard Deviation|Mean
52976|NCT01286740|Secondary|Plasma Concentration of RPV at Week 24|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.|Week 24|Participants with evaluable measurements for plasma concentration of RPV at Week 24 were analyzed.||ng/mL||Standard Deviation|Mean
52977|NCT01286740|Secondary|Plasma Concentration of EFV at Week 12|The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12|Week 12|Participants with evaluable measurements for plasma concentration of EFV at Week 12 were analyzed.||ng/mL||Inter-Quartile Range|Mean
52978|NCT01286740|Secondary|Plasma Concentration of RPV at Week 12|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.|Week 12|Participants with measurements for plasma concentration of RPV at Week 12 were analyzed.||ng/mL||Standard Deviation|Mean
52979|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 8|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.|Week 8|Participants with evaluable measurements for plasma concentration of RPV and EFV at Week 8 were analyzed.||ng/mL||Standard Deviation|Mean
52980|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 6|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.|Week 6|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 6 were analyzed.||ng/mL||Standard Deviation|Mean
52981|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 4|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.|Week 4|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 4 were analyzed.||ng/mL||Standard Deviation|Mean
52982|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 2|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.|Week 2|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 2 were analyzed.||ng/mL||Standard Deviation|Mean
52986|NCT01286740|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.|Week 12|Full Analysis Set: participants who were enrolled into the study, received at least one dose of study drug and had no major protocol violation||percentage of participants|||Number
52987|NCT01286558|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||participants|||Number
52988|NCT01286558|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||percentage of participants|||Number
52989|NCT01286558|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||percentage of participants|||Number
52990|NCT01286558|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP >=140 mmHg at reference baseline||percentage of participants|||Number
52991|NCT01286558|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated DBP >=90 mmHg at reference baseline||percentage of participants|||Number
52992|NCT01286558|Secondary|Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Deviation|Mean
52993|NCT01286558|Secondary|Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Deviation|Mean
52994|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
52995|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
52996|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
52997|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements||mm Hg||Standard Error|Least Squares Mean
52998|NCT01286558|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|FAS||mm Hg||Standard Error|Least Squares Mean
52999|NCT01286558|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|Full analysis set (FAS)||mm Hg||Standard Error|Least Squares Mean
53000|NCT01286493|Primary|Rabies Neutralizing Antibody Titers|"Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.~for 7 times in 1 year."|Day 360|As preliminary study, the number of participants was estimated to be above 15 - 20 cases.||IU/ml||Full Range|Geometric Mean
53001|NCT01286454|Secondary|Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.||hr||Standard Deviation|Mean
53002|NCT01286454|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
53003|NCT01286454|Primary|Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
53004|NCT01286454|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
53005|NCT01286454|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
53006|NCT01286402|Secondary|Perinatal/Neonatal Outcomes||at neonatal discharge from hospital following delivery||||||
53007|NCT01286402|Secondary|Maternal Side Effects||during treatment, end of treatment and at 2 week postpartum visit||||||
53008|NCT01286402|Secondary|Self-reported Reduction in Number of Cigarettes Smoked Per Day||at 1 week post treatment and at 2 week postpartum visit||||||
53009|NCT01286402|Secondary|Continuous Abstinence From Birth to 2nd Week Postpartum Followup||at 2nd week postpartum followup visit||||||
53010|NCT01286402|Secondary|Continuous Abstinence From End of Treatment Through the 2 Week Followup||at two week followup visit||||||
53011|NCT01286402|Secondary|Enrollment, Retention and Compliance Rates||1 year (estimated)||||||
53012|NCT01286402|Primary|7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment||1 week post treatment|||participants|||Number
53013|NCT01286324|Secondary|To Evaluate Any Changes From Baseline in the Safety and Tolerability of Chamomile|To evaluate any changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo.|once per week during study and day 28||||||
53014|NCT01286324|Secondary|To Determine the Change From Baseline of Chamomile on Daytime Functioning Measures|"Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days:~the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI);~the change from baseline of fatigue as determined by the Fatigue Severity Scale of Sleep Disorders (FSS);~the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})"|baseline and day 28||||||
53015|NCT01286324|Primary|Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.|"Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days:~the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals The total sleep time divided by time-in-bed, multiplied by 100. This measure is our primary aim (SE)."|baseline and day 28|||percentage of time asleep||Standard Deviation|Least Squares Mean
53016|NCT01286311|Secondary|Presence of an Aspirin Prescription|This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.|9 months|38 patients in the intervention arm and 50 patients in the control arm had aspirin listed in their medication list in the electronic medical record as the start of the study therefore they were excluded from this analysis.||% patients w/aspirin now on med list|||Number
53017|NCT01286311|Secondary|Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed|This will measure the percentage of participants who had uncontrolled hypertension at baseline who had an increase in the number of antihypertensive medication drug classes prescribed within 9 months.|9 months|Among patients with uncontrolled hypertension, 76 of the 218 in the intervention arm and 85 of 217 in the control arm were included.||percentage of participants|||Number
53018|NCT01286311|Secondary|Medication Prescriptions for Dyslipidemia|This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.|9 months|||% of patients with New Rx for LLM|||Number
53019|NCT01286311|Secondary|Frequency of Clinical Encounters|This will measure the difference in frequency of clinical encounters in the electronic medical record.|9 months|||% of patients with any office visit|||Number
53020|NCT01286311|Primary|Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction|Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline|9 months|||% of patients with major LDL reduction|||Number
53021|NCT01286207|Primary|Number of Participants With Drug-related Lab Adverse Experiences|"Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE).~A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product."|Up to 12 weeks|All patients who took study medication and had lab test(s)were included in the analysis.||participants|||Number
53022|NCT01286207|Primary|Number of Participants Who Discontinued Due to Clinical Adverse Experiences||Up to 12 months|All patients who took study medication were included in the analysis.||participants|||Number
53023|NCT01286207|Primary|Number of Participants With Drug-related Clinical Adverse Experiences|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Up to 12 months|All patients who took study medication were included in the analysis.||participants|||Number
53024|NCT01286207|Primary|Number of Participants With Serious Clinical Adverse Experiences|Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Up to 12 months|All patients who took study medication were included in the analysis.||participants|||Number
53025|NCT01286207|Primary|Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug|Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.|2 hours after initial dose of test drug|All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed.||percent of headaches||Inter-Quartile Range|Median
53026|NCT01286168|Secondary|Per Drain Analysis: Drain Bulb Fluid Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.||drains|Participants||Number
53027|NCT01286168|Secondary|Per Drain Analysis: Drain Tubing Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.||drains|Participants||Number
53028|NCT01286168|Primary|Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week||Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.||drains|Participants||Number
53029|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 1 Year||Approximately one year after surgery|||participants|||Number
53030|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 30 Days||Approximately 30 days after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.||participants|||Number
53031|NCT01286168|Secondary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.|Approximately 2 weeks after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.||participants|||Number
53032|NCT01286168|Secondary|Number of Subjects With Drain Tubing Colonization at Removal|Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.|Approximately two weeks after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.||participants|||Number
53033|NCT01286168|Primary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.|Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.||participants|||Number
53034|NCT01286129|Secondary|Change in Nasal Lavage Eosinophils After Allergen Challenge|Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge|At 7 hours post first and last challenge compared to baseline|||percentage of nasal lavage eosinophils||Standard Error|Mean
53035|NCT01286129|Primary|Change in Sputum Eosinophils Following Allergen Challenge|Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.|At 7 hours post first and last challenge compared to baseline|||percentage of sputum eosinophils||Standard Error|Mean
53036|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as PR based on IMWG response criteria as >=50% reduction of serum and reduction in 24-h urinary M protein by >=90% or to <200 mg/24 h; or serum/urine M protein unmeasurable:>=50% decrease in the difference between involved and uninvolved FLC levels; or serum/urine M protein and FLC assay unmeasurable: >=50% reduction in plasma cells provided baseline bone marrow plasma cell percentage was >=30%; or plus if present at baseline: >=50% reduction in size of soft tissue plasmocytomas.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Percentage of participants|||Number
53047|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)|Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), osteocalcin (Oc) and bone-specific alkaline phosphatase (BAP) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."||Microgram per liter||Standard Deviation|Mean
53037|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as SD based on IMWG response criteria as not meeting criteria for CR, VGPR, PR, or progressive disease; PD as Increase of >=25% from lowest response level in any one or more of the following: serum M protein (absolute increase >=0.5 g/dl)c or urine M protein (absolute increase >=200 mg/24 h); or serum/urine M protein unmeasurable: difference between involved and uninvolved free light chain (FLC) levels; absolute increase >10 mg/dL; or % bone marrow plasma cells: absolute value >=10% or definite development of new bone lesions or soft tissue plasmocytomas or definite increase in the size of existing bone lesions or soft tissue plasmocytomas; or development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Percentage of participants|||Number
53038|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Very Good Partial Response (VGPR) or Stringent Complete Response (sCR) or Complete Response (CR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as VGPR based on IMWG response criteria if, a) serum/urine M protein detectable by immunofixation but not on electrophoresis or; b) greater than or equal to 90% reduction in serum M protein plus urine M protein level less than 100 milligram/24 hour. CR=normal free light chain (FLC) ratio and absence of phenotypically aberrant plasma cells (PC) in bone marrow with a minimum of 3000 total PC analyzed by multiparametric flow cytometry; Complete response (CR) negative immunofixation on the serum and urine and, disappearance of any soft tissue plasmocytomas and <5% plasma cells in bone marrow.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Percentage of participants|||Number
53039|NCT01286077|Secondary|Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)|Subjects were asked to rate their general state of health on a Visual analog scale (in millimeter [mm]) ranging from 0 (worst state of health) to 100 (best conceivable state of health) mm.|Baseline up to end of study (approximately 4 years 7 months)|FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. Missing data was imputed by last observation carried forward (LOCF) method.||millimeter (mm)||Standard Deviation|Mean
53040|NCT01286077|Secondary|Overall Survival|Overall survival defined as time from first treatment of MMY, i.e. day of first dose of induction therapy for MMY to date of death|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||Months||Standard Error|Median
53041|NCT01286077|Secondary|Karnofsky Performance Status|"The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is perfect health and 0 is death."|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."||Units on a scale||Standard Deviation|Mean
53042|NCT01286077|Secondary|Change From Baseline in Spine T-score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."||T score||Standard Deviation|Mean
53043|NCT01286077|Secondary|Appearance of New Bone Lesions Compared to Baseline|Appearance of new bone lesions assessed by skeletal survey compared to baseline|Baseline up to end of study (approximately 4 years 7 months)|Data could not be summarised statistically due to insufficient data at End of treatment.||subjects|||Number
53044|NCT01286077|Secondary|Number of Patients With Skeletal Events|Number of patients with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."||patients|||Number
53045|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1)|Bone markers Dickkopf homolog 1 (DKK-1) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."||Picomole per liter||Standard Deviation|Mean
53046|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I)|Change from Baseline in Biochemical Bone Markers: CTX-I was assessed|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."||Nanogram per liter||Standard Deviation|Mean
53078|NCT01285635|Secondary|Incidence of Grade 3 and 4 Toxicities by Arm|Measure the grade III/IV toxicities experienced by patients with advanced, locally recurrent, or metastatic SCCHN|3 years|||participants|||Number
53079|NCT01285635|Secondary|Median Duration of Response For All Groups Combined||3 years|All patients on study||months||Full Range|Median
53048|NCT01286077|Secondary|Progression Free Survival|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to end of study (approximately 4 years 7 months)|Full Analysis Set (FAS) included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data.||Months||Standard Error|Mean
53049|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the end of treatment EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:8 patients in the bortezomib group and 8 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter||g/mm2||Standard Deviation|Mean
53050|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:13 patients in the bortezomib group and 14 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter||g/mm2||Standard Deviation|Mean
53051|NCT01286012|Secondary|Iron Delivery to the Erythron as Estimated by Hemoglobin Generation in Response to Erythropoietin (ESA Response Index, or ERI, Calculated as ESA Dose/Hgb). The ERI Will Also be Divided by Body Weight in Kilograms to Obtain a Modified ERI (ERI/kg).||Hemoglobin measured weekly; ESA dose recorded at each visit for 36 weeks, pre-dialysis body weight recorded at each visit for the first four weeks of the study and then weekly for the rest of the study.||||||
53052|NCT01286012|Secondary|Markers of Inflammation and Oxidative Stress||measured pre and post-dialysis at Week 1 Visit 2 and pre-dialysis at Weeks 4, 12, 24, and 36 of the study.||||||
53053|NCT01286012|Secondary|The Amount of Supplemental Intravenous (IV) Iron Needed.||Recorded at every dialysis session for 36 weeks|||mg/week||Standard Deviation|Mean
53054|NCT01286012|Secondary|Stability of Hemoglobin Over Time (Maintenance of Hemoglobin Between 9.5-11.5 g/dL, and Variability in Hemoglobin [Hgb-var]).||measured weekly for 36 weeks.||||||
53055|NCT01286012|Secondary|"The Incidence of Patient Failures, Defined as ≥ 25% Increase From Baseline in ESA Dose Sustained Continuously for ≥ 8 Weeks."||ESA dose is monitored and recorded at each dialysis session for 36 weeks.||||||
53056|NCT01286012|Secondary|"The Incidence of Patient Responders Defined as ≥ 25% Decrease From Baseline in ESA Dose Sustained Continuously for ≥ 8 Weeks."||ESA dose is monitored and recorded at each dialysis session for 36 weeks.||||||
53057|NCT01286012|Primary|The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb.|The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period.|Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks.|MITT population: Randomized subjects who received at least one dose of study drug and also received ESA during the treatment period.||Percent change||Standard Error|Least Squares Mean
53058|NCT01285947|Primary|Pain Rated by Subjects|"The mean pain scores will be compared between naïve subjects and non-naïve subjects averaged over the anatomical sites: periocular (temple), midface/cheek, and abdomen and over all the different treatments.~Pain scores were recorded along a Visual Analog Scale (VAS) with 0 (no pain- better) to 10 (maximal pain-worst). This is a 10 cm long line in which the subject was asked to draw a line on the scale with 0 (no pain- better) at one end to 10 (maximal pain-worst) at the other end. The drawn line was measured on the 10 cm line using a ruler to obtain the score."|3 hours for all treatments in one visit|||Units on a scale||Standard Deviation|Mean
53059|NCT01285908|Secondary|Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)|Plasma levels of dihydroxyphenylglycol are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||nmol/L||Standard Deviation|Mean
53060|NCT01285908|Secondary|Arterial Plasma Levels of Norepinephrine|Plasma levels of norepinephrine are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||nmol/L||Standard Deviation|Mean
53061|NCT01285908|Secondary|Total Peripheral Resistance|The extent to which norepinephrine infusion affected total peripheral resistance, by comparison of total peripheral resistance at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mmHg/(min/L)||Standard Deviation|Mean
53062|NCT01285908|Secondary|Cardiac Output|The extent to which norepinephrine infusion affects cardiac output, by comparison of cardiac output at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||L/min||Standard Deviation|Mean
53080|NCT01285635|Primary|Number of Patients With a Complete Response (CR) and Partial Response (PR)|The primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.|12 months|||Patients|||Number
53063|NCT01285908|Primary|Blood Pressure (Mean)|The extent to which norepinephrine infusion maintains average blood pressure, by comparison with the fractional changes in blood pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mm Hg||Standard Deviation|Mean
53064|NCT01285908|Secondary|Cardiac Stroke Volume|The extent to which norepinephrine infusion affects cardiac stroke volume, by comparison of cardiac stroke volume at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mL||Standard Deviation|Mean
53065|NCT01285908|Secondary|Heart Rate|The extent to which norepinephrine infusion affects heart rate, by comparison of beat-to-beat heart rate at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||bpm||Standard Deviation|Mean
53066|NCT01285908|Primary|Blood Pressure (Diastolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in diastolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mm Hg||Standard Deviation|Mean
53067|NCT01285908|Primary|Blood Pressure (Systolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.||mm Hg||Standard Deviation|Mean
53068|NCT01285843|Secondary|Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.|Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.|6 months, 1 year|||participants|||Number
53069|NCT01285843|Secondary|Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.|The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.|6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HAAS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).||units on a scale (0-18)||Standard Deviation|Mean
53070|NCT01285843|Secondary|Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score|"The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity.~The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative."|6 weeks, 6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HHS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).||units on a scale (0-100)||Standard Deviation|Mean
53071|NCT01285843|Primary|Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.||0-12 months|||g/cm2||Standard Deviation|Mean
53072|NCT01285791|Secondary|Change in Glucose and Triglyceride Blood Level|finding correlation between sonographic outcome using ultrasound, as measured by the decrease in the level of visceral fat-by centimeters, weight loss and blood levels of triglycerides and glucose.|18 months||||||
53073|NCT01285791|Primary|Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.|morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .|18 months|||visceral fat reduction in centimeters||Standard Error|Mean
53074|NCT01285713|Secondary|Dextrose Containing Intravenous Fluids (IVF) Affect Clinically Relevant Outcomes|Hypothesis 2: Admission rates, revisits to the emergency department (ED) or primary care physician, and length of illness will be decreased with the addition of dextrose to IVF. Physician and parental satisfaction will be increased with the addition of dextrose to IVF.|4 hours||||||
53075|NCT01285713|Primary|Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis|Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.|4 hours|||mmol/L||Standard Deviation|Mean
53076|NCT01285635|Secondary|Median Progression Free Survival in Months|Progression is defined, by RECIST (Response Evaluation Criteria in Solid Tumors), as at least a 20% increase in the sum of the longest diameter of target lesions.|3 Years|||months||95% Confidence Interval|Median
53077|NCT01285635|Secondary|Median Overall Survival in Months||3 Years|||months||95% Confidence Interval|Median
53081|NCT01285609|Secondary|Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy||months||95% Confidence Interval|Median
53082|NCT01285609|Secondary|Overall Survival (OS) in All Randomized Participants at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 705 deaths, up to June 2015 (approximately 48 months post study start)|All randomized participants||months||95% Confidence Interval|Median
53083|NCT01285609|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy||months||95% Confidence Interval|Median
53084|NCT01285518|Secondary|Volume of Distribution at Steady State (Vss) of PF-05231023|Vss was calculated by dividing the area under the first moment curve from time zero to infinity [AUMC(0-∞)] with the product of area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||L||Standard Deviation|Geometric Mean
53085|NCT01285518|Secondary|Back-extrapolated Concentration at Time Zero (C0) of PF-05231023|C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than [<] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.|0.25 H post-dose to Bo on Day 1|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. C0 was calculated for cohort 1 (group: PF-05231023 0.5 mg) and 2 (group: PF-05231023 1.5 mg) only as per planned analysis, hence results for the same reported.||ng/mL||Standard Deviation|Geometric Mean
53086|NCT01285518|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||ng*hr/ml||Standard Deviation|Geometric Mean
53087|NCT01285518|Secondary|Apparent Volume of Distribution (Vz) of PF-05231023|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||Liter||Standard Deviation|Geometric Mean
53088|NCT01285518|Secondary|Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.|Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||liter per hour||Standard Deviation|Geometric Mean
53114|NCT01285518|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Day 1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
53089|NCT01285518|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||hour||Standard Deviation|Mean
53090|NCT01285518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ng/mL||Standard Deviation|Geometric Mean
53091|NCT01285518|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||hour||Full Range|Median
53092|NCT01285518|Secondary|Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023|"Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).~Participants who received PF-05231023 with C-terminal and N-terminal AUClast were reported."|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ng*hour[H]/mL||Standard Deviation|Geometric Mean
53093|NCT01285518|Primary|Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry|Criteria for abnormal cardiac rhythms was based on investigator’s discretion and were reported as adverse event (AE), as planned.|From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.|||||
53094|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||mcg/mL||Standard Deviation|Mean
53095|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
53096|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
53097|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
53098|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||mcg/mL||Standard Deviation|Mean
53099|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
53100|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
53101|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. Here,'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
63554|NCT01175018|Secondary|Number of Deaths in Each Group||10-14 weeks|||deaths|||Number
53102|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||nanogram per millileter (ng/mL)||Standard Deviation|Mean
53103|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||nanogram per millileter (ng/mL)||Standard Deviation|Mean
53104|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.||ng/mL||Standard Deviation|Mean
53105|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
53106|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 34|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 34|Safety population. No participant was involved in groups: PF-05231023 0.5,1.5,5,15,50,100 mg and placebo for this time point of outcome measure, hence results were not reported for the same.'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
53107|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 22|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 22|Safety population included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
53108|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 15|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 15|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
53109|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 8|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 8|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.||participants|||Number
53110|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 1|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 1|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.||participants|||Number
53111|NCT01285518|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6*lower limit of normal (LLN) or >1.5*upper limit of normal (ULN).|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
53112|NCT01285518|Primary|Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels|Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose <50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration <=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration <=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration <=70 mg/dL).|Day 0 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
53113|NCT01285518|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec for PR interval and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Screening up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
53115|NCT01285518|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities was reported.|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
53116|NCT01285518|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
53117|NCT01285518|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator’s discretion and were reported as adverse event (AE), as planned.|Day -1 up to Day 22|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.|||||
53118|NCT01285492|Secondary|Change in Pre-dose Forced Vital Capacity (FVC) From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.||Litres||Standard Deviation|Mean
53119|NCT01285492|Secondary|Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.||Litres||Standard Deviation|Mean
53120|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia’s QTc Values at Any Time-point Over the Whole Treatment Period|Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
53121|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
53122|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
53123|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
53124|NCT01285492|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death|An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.|52 weeks|The safety set included all patients who received at least one dose of study drug.||Participants|||Number
53125|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53126|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53127|NCT01285427|Primary|SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53128|NCT01285427|Primary|SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53129|NCT01285427|Primary|SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53130|NCT01285427|Primary|SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53131|NCT01285427|Primary|SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53132|NCT01285427|Primary|SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53133|NCT01285427|Primary|All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)|All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks|||percentage of concordant alleles|Participants|90% Confidence Interval|Number
53134|NCT01285401|Post-Hoc|Percentage of Subjects With Disease Activity Free Status (Alternate Definition) at Week 48|Disease activity free (DAF) status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no confirmed expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions. Confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
53135|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48||Baseline, 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||millimeter^3 (mm^3)||Standard Deviation|Mean
53136|NCT01285401|Secondary|Percentage of Subjects Treated With Glucocorticoids Due to Relapses|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
53137|NCT01285401|Secondary|Total Number of Reported Relapses at All Time Points up to 48 Weeks|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||number of relapse per subject||Standard Deviation|Mean
53138|NCT01285401|Secondary|Annualized Relapse Rate at Week 48|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||relapse per year||Standard Deviation|Mean
53139|NCT01285401|Secondary|Number of Subjects With Relapse|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||subjects|||Number
53140|NCT01285401|Secondary|Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here “N” signifies number of subjects analyzed for respective outcome measure (here in the subgroup of subjects having new or enlarging T2 lesions).||percentage of new T1 hypointense lesions||Standard Deviation|Mean
53141|NCT01285401|Secondary|Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
53142|NCT01285401|Secondary|Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
53143|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)||Baseline, 48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subjects analyzed for respective outcome measure."||millimeter^3 (mm^3)||Standard Deviation|Mean
53144|NCT01285401|Secondary|Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new T2 lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||lesions per subject per scan||Standard Deviation|Mean
53145|NCT01285401|Secondary|Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new Relaxation time 2 (T2) lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||lesions per subject per scan||Standard Deviation|Mean
53146|NCT01285401|Secondary|Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48||48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subject analyzed for respective outcome measure."||lesions per subject per scan||Standard Deviation|Mean
53147|NCT01285401|Secondary|Number od Subjects With Confirmed EDSS Progression|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Baseline upto 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||subjects|||Number
53148|NCT01285401|Secondary|Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
53149|NCT01285401|Secondary|Percentage of Relapse-free Subjects at Week 48|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
53150|NCT01285401|Primary|Percentage of Subjects With Disease Activity Free Status up to Week 48|Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.|Up to Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.||percentage of subjects|||Number
53151|NCT01285323|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion.|Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52|Safety analysis set||participants|||Number
53152|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse (high): >100 and increase of >= 30 beats/minute~Sitting systolic blood pressure (low): <90 and decrease of >= 30 mmHg~Sitting systolic blood pressure (high): >160 and increase of >= 30 mmHg~Sitting diastolic blood pressure (low): <50 and decrease of >=12 mmHg (if 12-17 years old: <55 and decrease of >=12 mmHg 0~Sitting diastolic blood pressure (high): >100 and increase of >=12 mmHg~Respiratory rate (low): <6 breaths/minute~Respiratory rate (high): >24 and increase of >=10 breaths/minute~Body temperature (low): <35.8° Celsius~Body temperature (high): >=38.1 and increase of >=1.1° Celsius"|Week 4 to Week 52|Safety analysis set including participants who contributed data to the analysis||participants|||Number
53153|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Urate: M>=625, F>=506 μmol/L~Aspartate aminotransferase (AST): >=3*upper limit of normal (ULN)~Alanine aminotransferase (ALT): >=3*ULN~GGT = gamma-glutamyl transpeptidase: >= 3*ULN~Total bilirubin: >=34.2 μmol/L~White blood cells (low): <=3.0*10^9/L~White blood cells (high): >=20*10^9/L~Hemoglobin (age >=18 years): M<=115, F<=95 g/dL~Hematocrit (age >=18 years): M<0.37, F<0.32 L/L~Eosinophils/leukocytes: >=10.0%~Platelets: <=75*10^9/L~Neutrophils: <=1.0*10^9/L~Urinalysis: blood, ketones, glucose, and protein: >=2 unit increase from baseline"|Week 4 to Week 52|Safety analysis set, including participants who contributed to the analysis||participants|||Number
53167|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Year 2|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53154|NCT01285323|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.~Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.||CAEs in 52 weeks||95% Confidence Interval|Mean
53155|NCT01285323|Secondary|Participants With Treatment-Emergent Adverse Events TEAE)|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set||participants|||Number
53156|NCT01285323|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"The blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test. Results of all differential blood tests conducted after randomization were blinded.~The during treatment average eosinophil count was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. The 'over 16 weeks' value used data from Weeks 4, 8, 12 and 16. The 'over 52 weeks' value used all the during study time points listed in the Time Frame field.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set including patients who contributed at least once to the analysis.||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
53157|NCT01285323|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (Weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set including patients who contributed at least once to the analysis.||SABA puffs per day||Standard Error|Least Squares Mean
53158|NCT01285323|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.~The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
53159|NCT01285323|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 526 (longest treatment time plus 2 weeks)|Randomized set||weeks||95% Confidence Interval|Median
53168|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Year 2|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53160|NCT01285323|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
53161|NCT01285323|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of participants with assessments at each timepoint.||units on a scale||Standard Error|Least Squares Mean
53162|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. During study (Weeks 4, 8, 12 and 16) average value used a mixed effect model for repeated measures (MMRM) with treatment group, visit, treatment and visit interaction, and stratification factors as fixed effects and participant as a random effect. Covariates for baseline values were also included in the model; for pulmonary function test analyses, covariates for height and sex were included as well.~Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Includes participants who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
53163|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.~Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Week 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Number analyzed reflects participants with both baseline and Week 16 assessments.||liters||Standard Error|Least Squares Mean
53164|NCT01285323|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.||CAEs in 52 weeks||95% Confidence Interval|Mean
53165|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Year 2|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53166|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53184|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
53169|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53170|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means “not at all,” and 4 means “very much.” The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53171|NCT01285310|Secondary|Percentage Change From Baseline in the Individual American College of Rheumatology Components at Year 2|"The Individual ACR Components were defined as follows:~Tender Joint Count (out of 68 joints)~Swollen Joint Count (out of 66 joints)~Subject Assessment of Pain (0 to 100 mm VAS)~Subject Global Assessment of Disease Activity (0 to 100 mm VAS)~Physician Global Assessment of Disease Activity (0 to 100 mm VAS)~HAQ-DI Score~Acute Phase Reactant High Sensitivity C-Reactive Protein (hsCRP, mg/dL) Erythrocyte Sedimentation Rate (ESR)~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53172|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Year 2|"The DAS 28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's global assessment of disease activity (SGA ). A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53173|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53174|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53175|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Year 2|"The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53176|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
55629|NCT01257750|Secondary|Corneal Neovascular Area|Changes in neovascular area: measuring the area of the corneal vessels.|Through 12 weeks of Follow-Up||||||
53177|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Year 2|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.|||||
53178|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 52|"The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
53179|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
53180|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 52|Apremilast participants as randomized/transitioned (AAR Population); population consists of all participants who were randomized or transitioned to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
53181|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 52|Apremilast participants as randomized during the apremilast exposure period.||percentage of participants||95% Confidence Interval|Number
53182|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
53183|NCT01285310|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
53185|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 52|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
54056|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53186|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
53187|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 52|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
53188|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 52|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
53189|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 52|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
53190|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 52|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included..||percent change||Standard Deviation|Mean
53191|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 52|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percent change||Standard Deviation|Mean
53192|NCT01285310|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject’s global assessment of disease activity (SGA).~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
53193|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS),, where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
53201|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
53194|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
53195|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
53196|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
53197|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 52|"The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.~Reporting Groups"||percentage of participants||95% Confidence Interval|Number
53198|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 24|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 24|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
53199|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percentage of participants|||Number
53200|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
53426|NCT01283035|Secondary|Development of Feedback Loop Activation and Target Inhibition With Akt Inhibitor MK2206 Via Analysis of Pre-treatment and Post-treatment Biopsies in Select Patients Enrolled in the Trial||Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
53202|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53203|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 24|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53204|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53205|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 24|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53206|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 24|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53207|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 24|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53208|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 24|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53209|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 24|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percent change||Standard Error|Least Squares Mean
53239|NCT01285076|Secondary|Fear of Weight Gain Questionnaire|Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt).|1 year (during the 12-month period prior to the encounter visit)|The population analyzed only includes participants with available data.||Percentage of participants|||Number
57004|NCT01243320|Secondary|Mean Change in Heart Rate|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||bpm||95% Confidence Interval|Mean
53210|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) Using CRP at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's Global Assessment of Disease Activity.~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
53211|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||percentage of participants|||Number
53212|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
53213|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
53214|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.||percentage of participants|||Number
53215|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.||percentage of participants|||Number
53240|NCT01285076|Secondary|Experience of Weight Gain Questionnaire|Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms[kg]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded.|1 year (during the 12-month period prior to the encounter visit)|The population analyzed includes only participants with available data.||Percentage of participants|||Number
53444|NCT01282801|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
66862|NCT01139450|Secondary|The Mean Change From Baseline in Pruritus||Baseline, 4 weeks||||||
53216|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 16|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 16.||percent of participants|||Number
53217|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
53218|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 16|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
53219|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percentage of participants|||Number
53220|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
53221|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
53222|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 16|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject’s blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
53223|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 16|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
54057|NCT01274559|Secondary|Percent Change From Baseline in Triglyceride (TG) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53224|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
53225|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 16|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject’s current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||percent change||Standard Error|Least Squares Mean
53226|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 16|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
53227|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 16|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
53228|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 16|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
53229|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 16|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||percent change||Standard Error|Least Squares Mean
53230|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject’s global assessment of disease activity (SGA )~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
53231|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||percentage of participants|||Number
53241|NCT01285076|Secondary|Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II|This questionnaire measures a diabetic participant’s fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most).|6 months (during the 6-month period prior to the encounter visit)|The population analyzed includes only participants with available data.||Score on a scale||Standard Deviation|Mean
54058|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53232|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
53233|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.||units on a scale||Standard Deviation|Mean
53234|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Deviation|Mean
53235|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
53236|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
53237|NCT01285310|Primary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
53238|NCT01285076|Secondary|Self-reported Barrier Questionnaire|The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month.|30 days (during the 30-day period prior to the encounter visit)|All enrolled participants.||Participants|||Number
53269|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53242|NCT01285076|Secondary|Experience of Low Blood Sugar (Hypoglycemia) Questionnaire|The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale.|6 months (during the 6-month period prior to the encounter visit)|All enrolled participants.||Participants|||Number
53243|NCT01285076|Secondary|Number of Adherence Days on the Self-reported Adherence Questionnaire|The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence).|7 days (during the 7-day period prior to the encounter visit)|All enrolled participants.||Days||Standard Deviation|Mean
53244|NCT01285076|Secondary|Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life.|1 day (the day of the encounter visit)|All enrolled participants.||Score on a scale||Standard Deviation|Mean
53245|NCT01285076|Secondary|Score on the Quality of Life (EQ-5D) Questionnaire|The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best).|1 day (the day of the encounter visit)|The population analyzed includes only participants with available data.||Score on a scale||Standard Deviation|Mean
53246|NCT01285076|Primary|Number of Participants With Hypoglycemic Episodes|Participants self-reported hypoglycemic (low blood sugar) episodes.|6 months|All enrolled participants.||participants|||Number
53247|NCT01285076|Primary|Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%|HbA1c is measured as a percent.|6 months|The population analyzed includes only participants with available data.||participants|||Number
53248|NCT01285050|Primary|HCV RNA|HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.|48 hours after interferon administration|||log IU/ml||Inter-Quartile Range|Median
53249|NCT01285024|Secondary|Total Hemoglobin Level Change|Total hemoglobin level change from preop to postoperative discharge.|day of surgery - 1 week postoperative|||g/dL||Standard Deviation|Mean
53250|NCT01285024|Primary|Transfusion Requirement|Measure Title: Units of transfusion required|intraoperative - 1 week postoperative|||units||Standard Deviation|Mean
53251|NCT01284959|Secondary|Assessment of Cognitive Functioning-3|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included Wisconsin Card-Sorting Test (WCST). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.~Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Trials to complete first category trials is 0, Maximum is 128 and minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after th"|baseline and 50hr after third medication|||trials||Standard Deviation|Mean
53252|NCT01284959|Secondary|Assessment of Cognitive Functioning-2|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included the Stroop test, Trail-Making Test B (TMT B). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications Minimum of Stroop test is 0, no maximum limit, the higher number is worse outcome.~Minimum of Trail making test B is 0 and no maximum limit, the higher number is worse outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication|||milliseconds||Standard Deviation|Mean
53253|NCT01284959|Secondary|Symptoms Assessment by Objective Rating Scales|SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) Minimum of NIDSS is -3, maximum of NIDSS is +3. '+' is better outcome, '-' is worse outcome. Minimum of SNAS-Global score is 0, Maximum of SNAS-Global score is 5 The higher number is worse outcome. The zeros are measured and Calcuated value. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication|||units on a scale||Standard Deviation|Mean
53254|NCT01284959|Secondary|Assessment of Cognitive Functioning-1|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included a word fluency test. All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.~Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.~Minimum of Word-fluency test is 0 and no maximum value, the higher number is better outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication|||scores on a scale||Standard Deviation|Mean
53270|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53498|NCT01282203|Secondary|Anesthesiologists' Duration of Clinical Experience With Anesthesia|Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.)|Baseline|Number of anesthesiologists participating in study.||years||Standard Deviation|Mean
53255|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS is 0, Maximum is 10 Minimum of DIEPSS is 0, Maximum is 4 The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication|||units on a scale||Standard Deviation|Mean
53256|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|"DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert–drowsy, muzzy–clear headed, mentally slow–quick witted, attentive–dreamy), physical sedation (strong–feeble, well coordinated–clumsy, lethargic–energetic, incompetent–proficient), tranquilization (calm–excited, contented–discontented, troubled–tranquil, tense–relaxed), and other types of feelings (happy–sad, antagonistic–amicable, interested–bored, withdrawn–gregarious) Minimum of VAS(Mental sedation score,Physical sedation score,Total score) is 0, Maximum is 10.~VAS-total score is average of all subscale scores. Minimum of DIEPSS is 0, Maximum is 4. The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication|||units on a scale||Standard Deviation|Mean
53257|NCT01284959|Primary|Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales|"SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total.~Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication|||units on a scale||Standard Deviation|Mean
53258|NCT01284634|Secondary|Incidence of Adverse Events (AEs) as a Measure of Patient Safety|All reported AEs were classified by system organ class (SOC), preferred term (PT) and low level term using version 13.1 of the MedDRA dictionary. The number of subjects who experienced an AE during the study is presented.|From 0 -10 weeks (study duration)|All randomised subjects were analysed.||participants|||Number
53259|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin|A fasting blood sample was obtained for the measurement of fasting serum insulin. An increase from baseline (i.e. a positive value) indicates an improvement in condition.|After 56 days of treatment|A reduction from baseline (i.e. a negative value) indicates an improvement in condition.||pmol/l||Standard Deviation|Mean
53260|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight|A reduction from baseline (i.e. a negative value) in the amount of fat as a percentage of body weight indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||total fat as apercentage of body weight||Standard Deviation|Mean
53261|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Abdominal Adiposity|Abdominal adiposity = ratio of total abdominal to total non-abdominal fat. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||ratio||Standard Deviation|Mean
53262|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Fat|Total fat = total abdominal + total non-abdominal fat. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53263|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53264|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Internal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53265|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53266|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53267|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53268|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Abdominal Fat|As measured by MRI/MRS scanning. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||litres||Standard Deviation|Mean
53271|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness|Total skin fold thickness was based on the sum of the average values from the seven sites stated above. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53272|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53273|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53274|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53275|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53276|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53277|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53278|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)|Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mm||Standard Deviation|Mean
53279|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Hip Measurement|Hip circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||cm||Standard Deviation|Mean
53280|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Waist Measurement|Waist circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||cm||Standard Deviation|Mean
53281|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Neck Measurement|The neck circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||cm||Standard Deviation|Mean
53282|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio|The waist-to-hip ratio was calculated at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||ratio||Standard Deviation|Mean
53283|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Body Weight|Body weight (kg) was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||kg||Standard Deviation|Mean
53284|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)|Individual subject's BMIs were calculated by dividing mass (kg) by height (m2). A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||kg/m2||Standard Deviation|Mean
53285|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels|A fasting blood sample was obtained for the measurement of fasting plasma glucose. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
53286|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels|A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
53287|NCT01284634|Secondary|Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio|A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline (i.e. a positive value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||ratio||Standard Deviation|Mean
53288|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels|A fasting blood sample was obtained for the measurement of LDL-C. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
53289|NCT01284634|Secondary|Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels|A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline (i.e. a positive value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
53290|NCT01284634|Secondary|Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels|A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||mmol/l||Standard Deviation|Mean
53291|NCT01284634|Primary|Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels|Liver triglyceride levels (%) were measured by MRI/MRS scanning and the change from baseline to end of treatment in group mean levels were investigated. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.|After 56 days of treatment|All subjects who were randomised and received treatment were included and analysed according to their randomised treatment group.||percentage of liver triglycerides||Standard Deviation|Mean
53292|NCT01284621|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Tolerability|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From drug administration until end of washout period (36 days)|Treated set which included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||participants|||Number
53293|NCT01284621|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/Fss)|Apparent volume of distribution at steady-state during the terminal phase λz following an extravascular dose.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
53294|NCT01284621|Secondary|Apparent Clearance After Extravascular Administration (CL/Fss)|Apparent clearance of the analyte in plasma after extravascular administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
53295|NCT01284621|Secondary|Mean Residence Time (MRTpo,ss)|Mean residence time of the analyte in the body after oral administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Geometric Coefficient of Variation|Geometric Mean
53296|NCT01284621|Secondary|Terminal Half-life (T 1/2,ss)|Terminal half-life of the analyte in plasma at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Geometric Coefficient of Variation|Geometric Mean
53297|NCT01284621|Secondary|Terminal Rate Constant (λz,ss)|Terminal rate constant in plasma at steady-state|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
60996|NCT01196104|Secondary|Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation||Baseline to Week 16|Safety Population||Cough episodes|||Number
53298|NCT01284621|Secondary|Time From Last Dosing to the Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Full Range|Median
53299|NCT01284621|Secondary|Ramiprilat: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|"Predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramiprilat.~Note, predose concentrations for ramipril were all below the limit of quantification (BLQ) and therefore the predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramipril was not analysed."|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
53300|NCT01284621|Secondary|Empa: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|Predose concentration of the analyte in plasma prior to administration of the Nth dose, of empagliflozin.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
53301|NCT01284621|Primary|Total Ramiprilat: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramiprilat.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
53302|NCT01284621|Primary|Total Ramiprilat: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramiprilat (active metabolite of ramipril).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
53303|NCT01284621|Primary|Total Ramipril: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
53304|NCT01284621|Primary|Total Ramipril: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
53305|NCT01284621|Primary|Total Empa: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
53306|NCT01284621|Primary|Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
53307|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
54059|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53308|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
53309|NCT01284517|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
53310|NCT01284504|Secondary|Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.||30 days||||||
53311|NCT01284504|Primary|Blood Samples Taken Before Initiation of Study, Day of Surgery, Days 1 and 3 Post-op, and 30 Days Post-op. Analyzed for 50 Serum Cytokines, Cell-specific Gene Expression, and TCR Repertoire.||2 years||||||
53312|NCT01284504|Primary|Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling|One patient was accrued and withdrawn after signing consent; None was treated.|2 years||||||
53313|NCT01284491|Primary|Scar Quality|The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.|0-18 months following breast reduction surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
53314|NCT01284426|Primary|Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.|"Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria.~Description in details:~Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported."|6 years|Children 4-15 years old with chronic urticaria||percentage of participants|||Number
53315|NCT01284361|Secondary|Assessment of Ease of Use Characteristics|"Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the top two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree."|1 week|82 self-catheterizing wheelchair-using men||percentage of participants|||Number
53316|NCT01284361|Primary|Percentage of Participants|Percentage of participants that preferred the 40 cm catheter|1 week|||percentage of participants|||Number
53317|NCT01284296|Primary|Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.||A minimum of 2-4 differences recorded approximately hourly during surgery|||percentage of hemoglobin readings|Participants||Number
53318|NCT01284114|Primary|The Change of Urine Albumin/ Creatinine Ratio (UACR).|The UACR was measured at baseline, Week12 and Week24|baseline and 6 months|We analyzed all patients who completed this study.||mg/g||Standard Deviation|Mean
53319|NCT01284114|Primary|The Change of eGFR|eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73 m2) = 194 × age-0.287 × serum creatinine-1.094 (multiplied by 0.739 for females).|baseline and 6 month|We analyzed all patients who completed study.||mL/min/1.73m2||Standard Deviation|Mean
53320|NCT01284114|Secondary|The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM||6 months||||||
53321|NCT01284114|Primary|The Change of BNP|Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6month|We analyzed all patients who completed study.||pg/ml||Standard Deviation|Mean
53322|NCT01284114|Primary|The Change of Heart Function Confirmed by Echocardiograph|Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month. Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6 month|We analyzed participants who copmleted this study||% of stroke vulume/enddiastolic volume||Standard Deviation|Mean
53323|NCT01284114|Primary|The Change of Blood Pressure|The change of systolic blood pressure and diastolic blood pressure|baseline and 6 month|We analyzed all patients who completed study.||mmHg||Standard Deviation|Mean
53324|NCT01284062|Secondary|Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||participants|||Number
53325|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Rectal Bleeding at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||participants|||Number
61184|NCT01195090|Secondary|Baseline High-density Lipoprotein Cholesterol (HDL-C)|Baseline HDL-C|Baseline|Baseline HDL-C||mg/dl||Standard Deviation|Mean
53326|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Stool Frequency at Week 14|Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||participants|||Number
53327|NCT01284062|Other Pre-specified|Change From Baseline in Total Mayo Score at Week 14|The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||unit on a scale||95% Confidence Interval|Least Squares Mean
53328|NCT01284062|Other Pre-specified|Clinical Remission Rate at Week 14|Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||percentage of participants||95% Confidence Interval|Number
53329|NCT01284062|Other Pre-specified|Clinical Response Rate at Week 14|Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||percentage of participants||95% Confidence Interval|Number
53330|NCT01284062|Secondary|Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody|Neutralizing antibody was not analyzed as no participant had positive ADA samples.|Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.||participants|||Number
53331|NCT01284062|Secondary|Number of Participants Who Discontinued From the Study Due to Adverse Events||Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
53332|NCT01284062|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.|Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.||participants|||Number
53333|NCT01284062|Secondary|Total Interleukin-13 (IL-13) Level||Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.||picogram/milliliter||Standard Deviation|Mean
53334|NCT01284062|Secondary|Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12|The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.|Baseline, Week 2, 4, 8, 12|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.||fold change||95% Confidence Interval|Least Squares Mean
53335|NCT01284062|Secondary|Volume of Distribution (Vz) for Anrukinzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||liters||Standard Deviation|Mean
53645|NCT01280591|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53336|NCT01284062|Secondary|Systemic Clearance (CL) for Anrukinzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||liters/day||Standard Deviation|Mean
53337|NCT01284062|Secondary|Plasma Decay Half-Life (t1/2) for Anrukinzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||hours||Standard Deviation|Mean
53338|NCT01284062|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab|Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.|Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. Number of participants analyzed signifies those participants who were evaluable for this outcome measure."||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
53339|NCT01284062|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab|Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” signifies participants in PK population; n signifies evaluable participants at specified time point."||ng/mL||Standard Deviation|Mean
53340|NCT01284062|Secondary|Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab|Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable pharmacokinetic (PK) results were included in PK population. PK samples with time deviation greater than (>) 20 percent (%) from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” = participants in PK population; n = evaluable participants at specified time point."||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
53341|NCT01284062|Primary|Fold Change From Baseline in Fecal Calprotectin at Week 14|The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.|Baseline, Week 14|Modified Intent to Treat (mITT: all randomized participants who received greater than or equal to [>=] 1 dose study drug); Data as Observed (DAO: all mITT participants with all data needed for calculation of specified endpoint). “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.||fold change||95% Confidence Interval|Least Squares Mean
53342|NCT01283971|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Discontinuation Due to AEs and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|32 weeks|Safety Population included all participants who received study drug and who had at least 1 post-dose safety assessment.||Participants|||Number
53343|NCT01283971|Secondary|Change From Baseline in Hemoglobin at Week 24|Blood was collected at Baseline and Week 24. The samples were sent to a central laboratory for Hemoglobin analysis reported in gram/deciliter (g/dL). A positive number change from Baseline (a higher hemoglobin level compared to Baseline) indicated improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with hemoglobin data available at Baseline and Week 24.||g/dL||Standard Deviation|Mean
53344|NCT01283971|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 24|RAPID3 is a patient self reported assessment that combines the HAQ-DI [20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions answered on a 4-point scale where 0=without any difficulty to 3=unable to do} converted to a score of 0-10, the Patients Assessment of Pain [Over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain] converted to a score of 0-10 and the Patient's Global Assessment of Disease Activity [over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity] converted to a score of 0-10. The 3 individual scales are summed for a raw score of 0-30 which is divided by 3 to achieve a total possible adjusted score of 0-10. A negative change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||Score on a scale||Standard Deviation|Mean
53345|NCT01283971|Secondary|Change From Baseline in Quality of Life Short Form (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||Score on a scale||Standard Deviation|Mean
53346|NCT01283971|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
53347|NCT01283971|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
53348|NCT01283971|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeter/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||mm/hr||Standard Deviation|Mean
53349|NCT01283971|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 24|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The concentration of CRP was measured in milligram/liter (mg/L). A reduction in the level is considered an improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.||mg/L||Standard Deviation|Mean
53350|NCT01283971|Secondary|Change From Baseline in the Physician Global Assessment of Disease Activity VAS at Week 24|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
53351|NCT01283971|Secondary|Change From Baseline in the Patient Global Assessment of Disease Activity VAS at Week 24|"The patient's global assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
53352|NCT01283971|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 24|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.||Score on a scale||Standard Deviation|Mean
53353|NCT01283971|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation carried forward was used to impute missing tender joint counts.||Joint count||Standard Deviation|Mean
53354|NCT01283971|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation was used to impute missing swollen joint counts.||Joint count||Standard Deviation|Mean
53378|NCT01283555|Secondary|Number of Participants Reporting That the Gel Was Easy to Dispense|"Participants were asked to describe the dispensing of the gel into the vagina with each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53679|NCT01279564|Primary|In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube||1 year||||||
61757|NCT01191242|Primary|(S)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
53355|NCT01283971|Secondary|Change From Baseline in DAS28 Score at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.||Score on a scale||Standard Deviation|Mean
53356|NCT01283971|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. LDAS is defined as DAS28 ≤3.2.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.||Percentage of participants|||Number
53357|NCT01283971|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) DAS28 Responses at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total score ranges from 0 (best) to 10 (worst). A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other EULAR components were used as observed.||Percentage of participants|||Number
53358|NCT01283971|Secondary|Percentage of Participants With ACR70 Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
53359|NCT01283971|Secondary|Percentage of Participants With ACR50 Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
53360|NCT01283971|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
53379|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Insert|"Participants were asked to describe the insertion of the applicator into the vagina for each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53642|NCT01280591|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53361|NCT01283971|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. DAS28 Remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.||Percentage of participants|||Number
53362|NCT01283581|Secondary|Clinical Response Rate in Subjects With Infections Caused by MRSA||up to Late Follow-up||||||
53363|NCT01283581|Secondary|Microbiological Response Rate in All Subjects and in Subjects With Infections Caused by MRSA||up to Late Follow-up||||||
53364|NCT01283581|Secondary|The Levels of Biochemical Markers of Inflammation||on Days 1, 5, Follow-up, and late Follow-up||||||
53365|NCT01283581|Secondary|Steady State Pharmacokinetic Parameters in Subjects Administered Delafloxacin, Vancomycin, and Linezolid||Through Day 3 (± 1 day)||||||
53366|NCT01283581|Secondary|Erythema Clinical Success|The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.|48 - 72 hours|ITT (intent-to-treat) population, defined as all subjects who were randomized.||Participants|||Number
53367|NCT01283581|Primary|Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up and Late Follow-up.|The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.|Follow-up (Day 14 ± 1) and late follow-up (Day 21-28)|ITT (intent-to-treat) population, defined as all subjects who were randomized.||Participants|||Number
53368|NCT01283555|Secondary|Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention|"Participants were asked if they would recommend the user-filled applicator to other women if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53369|NCT01283555|Secondary|Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if there were any reasons that they would not want to use this user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53370|NCT01283555|Secondary|Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if they would use the user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53371|NCT01283555|Primary|Number of Colposcopic Findings (Baseline and After One Week of Product Use)|Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator|7 days|The number of participants for analysis was determined by counting the number of participants with colposcopic findings and baseline and after one week of product use.||colposcopic findings|Participants||Number
53372|NCT01283555|Secondary|Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator|"Participants were asked if the cost of the applicator would influence their choice of applicator.~Response categories were yes, no, and maybe."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53373|NCT01283555|Secondary|Number of Participants Reporting That Both Applicators Were Acceptable|"Participants were asked if both applicators were acceptable to them. Responses were either yes or no."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53374|NCT01283555|Secondary|Number of Participants Reporting That the Instructions for Use Were Helpful|"For each applicator type, participants were asked if the instructions were helpful to you.~Response categories were yes and no."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53375|NCT01283555|Secondary|Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort|"Participants were asked if they could suggest ways that would make each applicator easier or more comfortable to use. Response categories were yes and no. If yes, participants were asked to describe how they would make the applicator easier and/or more comfortable to use."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53376|NCT01283555|Secondary|Number of Participants Reporting That Applicator Was Comfortable to Use|"Participants were asked to describe the comfort of use for each applicator type(user-filled and prefilled).~Response categories included comfortable, neutral, and uncomfortable."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53377|NCT01283555|Secondary|Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors|"Participants were asked about their preference for either the user-filled or prefilled applicator with regard to several use factors as well as in relation to disposal, storage, and overall comfort and preference.~Response categories included user-filled, prefilled, and same."|Final study visit (after completing both study arms)|All participants were included in the analysis.||responses|||Number
53423|NCT01283035|Secondary|Toxicities of Akt Inhibitor MK2206, as Assessed by the Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)||Up to 3 years|Number of participants experiencing toxicities.||participants|||Number
53380|NCT01283555|Secondary|Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly|"Participants were asked how did they know when the applicator was filled correctly (that is, with the right amount of gel). More than one answer was allowed.~Response categories included plunger automatically stopped, the 'FULL' line was reached, and other.~Note: this question does not apply to the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis. Each participant could identify multiple reasons. As a result, the number of units analyzed is greater than the number of participants.||participants|Participants||Number
53381|NCT01283555|Secondary|Number of Respondents Reporting Confidence With Filling the User-filled Applicator|"Participants were asked when using the user-filled applicator, how confident did they feel that they at inserted the correct amount of gel into the applicator.~Response categories included very confident, confident, and not confident.~(Note: this question does not apply to the prefilled applicator.)"|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53382|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Fill|"Participants were asked to describe the process of filling the user-filled applicator.~Response categories included easy, moderately difficult, and difficult.~Since ease of filling only applies to the user-filled applicator, this question was not applicable for the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis.||participants|||Number
53383|NCT01283555|Secondary|Dosing Accuracy (% of Target Dose Delivered)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The average dose delivered for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||percent of target dose delivered|Participants||Number
53384|NCT01283555|Secondary|Dosing Precision, 10% (Expressed Volume)|A 10% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
53385|NCT01283555|Secondary|Dosing Precision, 5% (Expressed Volume)|A 5% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
53386|NCT01283555|Secondary|Dosing Volume (Expressed Volume)|At each dose delivery visit, the applicator was weighed prior to vaginal insertion and after use. The volume of gel expressed was measured using the following data: weight of filled applicator, weight of emptied applicator, the average weight of an empty applicator, and gel density.|3 dose delivery measurements during 1 week of product use|Per protocol, all participants were included in the analysis.||ml|Participants|Standard Deviation|Mean
53387|NCT01283555|Secondary|Filling Accuracy (% of Target Dose)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The filled volume for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||% of target dose filled into applicator|Participants||Number
53388|NCT01283555|Secondary|Filling Precision (10% Range)|A 10% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
53389|NCT01283555|Secondary|Filling Precision (5% Range)|A 5% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||doses|Participants||Number
53390|NCT01283555|Secondary|Filled Volume|At each dose delivery visit, the applicator was weighed, prior to vaginal insertion. For the user-filled applicator, the participant handed the applicator to the investigator after filling with gel from the multidose tube. The applicator was then weighed and returned to the participant for insertion. For the prefilled applicator, the participant inserted the plunger into the barrel, and then handed the applicator to the investigator for weighing.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.||ml|Participants|Standard Deviation|Mean
53391|NCT01283516|Primary|Duration of Response (DOR) Based on Investigator Assessment|As per Kaplan-Meier estimate. Duration of response (DOR) is defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.|33 months|Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and received prior crizotinib and had a confirmed overall complete response or partial response after initiation of LDK378.||Months||95% Confidence Interval|Median
53392|NCT01283516|Primary|Overall Response Rate (ORR) Based on Investigator Assessment|Overall response rate (ORR) is defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).|33 months|Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and received prior crizotinib||Percentage of Participants||95% Confidence Interval|Number
53424|NCT01283035|Secondary|Duration of Progression-free Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
53393|NCT01283516|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.|33 months|Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.||Participants|||Number
53394|NCT01283516|Secondary|Absorption and Plasma Concentrations of LDK378||120 weeks||05/2017||||
53395|NCT01283516|Secondary|Type and Category of Study Drug Related Adverse Events||120 weeks||05/2017||||
53396|NCT01283464|Primary|Global Photodamage Severity|A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage.|Week 24|||units on a scale||Standard Deviation|Mean
53397|NCT01283334|Secondary|Progression-free Survival (PFS)|Objective tumor responses were assessed every 2 cycles of chemotherapy with computed tomography or positron emission tomography/ computed tomography scans in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|The time of PFS was calculated as the time from study enrollment to the disease progression date, death date, or last contact, whichever came first, up to 25 months|||months||Full Range|Median
53398|NCT01283334|Primary|To Measure the Safety and Clinical Effectiveness of the Combination of Carboplatin, Cetuximab and RAD001 in Patients With Advanced (Recurrent or Metastatic) Head and Neck Cancer|This phase 1 clinical trial used a standard 3 + 3 design. Four dose levels of everolimus were planned to be evaluated, and the standard 3 + 3 design with dose de-escalation was used in the trial. Namely, 3 patients were assigned to starting dose level 1. If no dose-limiting toxicity (DLT) was observed, the trial proceeded to the next dose level, and another cohort of 3 patients was enrolled. If at least 2 of the 3 patients experienced at least 1 DLT, then the dose level decreased; otherwise, if only 1 patient experienced DLT, then 3 more patients were enrolled at the same dose level. If none of the 3 additional patients experienced DLT, the dose was escalated; otherwise, the dose level decreased. Dose reduction continued until a dose level was reached at which 6 patients had been treated and at most 1 DLT was observed.|Within the first 21 days of therapy|||participants|||Number
53399|NCT01283321|Secondary|Blood Loss||Operative period||||||
53400|NCT01283321|Secondary|Units of Platelets and Allogeneic Red Cells Transfused- During Surgery and up to 24 Hours After Surgery||Peri-operative period||||||
53401|NCT01283321|Secondary|Units of Fresh-frozen Plasma (FFP) Transfused-during Surgery and up to 24 Hours After Surgery||Peri-operative period||||||
53402|NCT01283321|Secondary|Proportion of Patients in the Fibrinogen Group in Whom Transfusion of Fresh Frozen Plasma or Platelet Concentrate is Required During or After Surgery||Operative period||||||
53403|NCT01283321|Primary|Bleeding Scores|Bleeding scores are scored on a four-point scale. A visual assessment of surgical field was performed by the senior surgical staff as follows: 0 = excellent hemostasis (dry field), 1 = mild bleeding (oozing), 2 = moderate bleeding (controllable with applied pressure), and 3 = severe bleeding (multiple diffuse bleeding sites). If the visual bleeding scale was 2 to 3, the subjects were randomly assigned to a study intervention using a closed envelope method.|intra-operatively and up to 24 hours postoperatively|||units on a scale||Standard Deviation|Mean
53404|NCT01283282|Secondary|Inflammatory Marker CD40 Ligand|CD40 ligand levels were measured. The level of CD40 ligand were measured using the Flurokine MultiAnalyte profiling (MAP) Human Base Kit B.|Week 12|||pg/mL||Standard Error|Mean
53405|NCT01283282|Secondary|Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)|High-sensitivity C-reactive protein (hsCRP) was measured. The hsCRP levels were measured by Dade Behring nephelometry.|Week 12|||mg/L||Standard Error|Mean
53406|NCT01283282|Secondary|Oxidative Stress Markers|Oxidative stress was measured by using liquid chromatography to collect plasma cystine, cysteine, gluthione, and oxidized glutathione levels.|Week 12|||µM||Standard Error|Mean
53407|NCT01283282|Secondary|Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in seconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Week 12|||m/s||Standard Error|Mean
53408|NCT01283282|Primary|Endothelial Progenitor Cells (EPCs)|The circulating progenitor-enriched population of cells was measured by the expression of surface antigens using direct flow cytometry for CD34+, CD34+/CD133+, CD34+/ VEGF2R+ and CD34+/CD133+/VEGF2R+|Week 12|||cells/µL||Standard Error|Mean
53409|NCT01283282|Primary|Nitroglycerin-mediated Vasodilation|Nitroglycerin (NTG)-mediated vasodilation was measured after 0.4 mg of NTG was administered sublingually. Brachial artery images were obtained via ultrasound after three minutes of NTG administration. Measurements from the twelve frames will be averaged to calculate the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12|||percent change in diameter||Standard Error|Mean
53410|NCT01283282|Primary|Flow-mediated Dilation (FMD)|Flow-mediated dilation (FMD) collected by an ultrasound and is measured by the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12|||percent change in diameter||Standard Error|Mean
53411|NCT01283152|Primary|Change in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study||participants|||Number
53412|NCT01283152|Secondary|Hospital Duration/Length of Stay||From time of admission to time of discharge or death|||days||Standard Deviation|Mean
53425|NCT01283035|Secondary|Duration of Overall Survival Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
53413|NCT01283152|Primary|Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study||participants|||Number
53414|NCT01283139|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs|The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs.|Day 1 up to Week 56|The safety population included all participants who received any investigational product.||participants|||Number
53415|NCT01283139|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.||participants|||Number
53416|NCT01283139|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.||participants|||Number
53417|NCT01283139|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.|Day 1 up to Week 74|The safety population included all participants who received any investigational product.||participants|||Number
53418|NCT01283139|Secondary|Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a FACIT-fatigue score <49 at baseline."||percentage of participants|||Number
53419|NCT01283139|Secondary|Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction|The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a CLASI activity score >=10 at baseline."||percentage of participants|||Number
53420|NCT01283139|Secondary|Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day|Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants on >=10 mg/day oral prednisone (or equivalent) at baseline."||percentage of participants|||Number
53421|NCT01283139|Primary|Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants|SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with positive diagnostic test."||percentage of participants|||Number
53422|NCT01283139|Primary|Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])|SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline).|Day 365|The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.||percentage of participants|||Number
61758|NCT01191242|Primary|Total EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
53427|NCT01283035|Secondary|Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 (as Assessed by Objective Tumor Response, Progression-free Survival, and Overall Survival)|The frequency of mutations in the PI3K/AKT and RAS pathways, copy number alterations, and PTEN loss and AKT expression as assessed by IHC will be tabulated. Associations between these markers with clinical outcome such as response rate and duration of PFS will be assessed.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.|||||
53428|NCT01283035|Primary|Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|"If 4 or more of the final set of 29 patients demonstrate a response, then the null hypothesis H0: =< 5% can be rejected in favor of the alternative hypothesis H1: >= 20% with an alpha of 0.05 and beta of 0.20 (i.e., 80% power).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|Up to 3 years|Five patients started study treatment.||participants|||Number
53429|NCT01283022|Primary|Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.||pg/mL||Standard Deviation|Median
53430|NCT01283022|Secondary|Rate of Adverse Events.|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48-72 hours).|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.||percentage of participants|||Number
53431|NCT01283022|Primary|Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal.|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.||hours||Standard Deviation|Median
53432|NCT01282866|Secondary|Hair Count|"The hair at the treatment area is counted at Baseline and 15 months following the last treatment.~Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline."|15 month following last treatment|The number of participants who completed 15 months follow up was 23 out of 35.||percentage of hair clearance||Standard Deviation|Mean
53433|NCT01282866|Secondary|Level of Comfort Associated With Treatment||Each treatment||||||
53434|NCT01282866|Secondary|Treatment Time|The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.|Each treatment|||minutes||Standard Deviation|Mean
53435|NCT01282866|Primary|Hair Count|"The hair at the treatment area is counted at Baseline and 6 months following the last treatment.~Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline."|6 month following last treatment|||percentage of hair clearance||Standard Deviation|Mean
53436|NCT01282814|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
53437|NCT01282814|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
53438|NCT01282814|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
53439|NCT01282801|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
53440|NCT01282801|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
53441|NCT01282801|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
53442|NCT01282801|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
53443|NCT01282801|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
53445|NCT01282723|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers|The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.|9 - 42 Minutes|||Odds Ratio||95% Confidence Interval|Number
53446|NCT01282710|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC|Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.|9 - 42 Minutes|||Seconds||Standard Deviation|Mean
53447|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: AUClast|AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set: Participants enrolled in the PK substudy were analyzed.||hours x ng/mL||Standard Deviation|Mean
53448|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: Tmax|Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set||hours||Inter-Quartile Range|Mean
53449|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: Cmax|Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set: Participants enrolled in the PK substudy were analyzed.||ng/mL||Standard Deviation|Mean
53450|NCT01282424|Secondary|Idelalisib Plasma Concentration||Predose and at 1.5 hours (± 5 minutes) postdose on Day 29|||ng/mL||Standard Deviation|Mean
53451|NCT01282424|Secondary|Study Drug Exposure|The average idelalisib exposure was summarized.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||months||Standard Deviation|Mean
53452|NCT01282424|Secondary|Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms|"This composite endpoint measured the safety and tolerability profile of idelalisib. Clinically meaningful abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator."|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||participants|||Number
53453|NCT01282424|Secondary|Change in Karnofsky Performance Status|The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
53454|NCT01282424|Secondary|Change in Health-related Quality of Life|"Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline.~The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications."|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set with available data were analyzed.||units on a scale||Standard Deviation|Mean
53455|NCT01282424|Secondary|Overall Survival|Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||months||95% Confidence Interval|Median
53456|NCT01282424|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||months||95% Confidence Interval|Median
53457|NCT01282424|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.||months||Inter-Quartile Range|Median
53458|NCT01282424|Secondary|Lymph Node Response Rate|Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
53459|NCT01282424|Secondary|Duration of Response|Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.||months||Inter-Quartile Range|Median
53485|NCT01282294|Primary|Functional Outcome: IOWA Ankle Score|The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.|Baseline, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
61185|NCT01195090|Secondary|Baseline Low-density Lipoprotein Cholesterol (LDL-C)|Baseline LDL-C|Baseline|Baseline LDL-C||mg/dl||Standard Deviation|Mean
53460|NCT01282424|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of subjects achieving a complete response (CR) or partial response (PR; or minor response [MR] for subjects with Waldenström macroglobulinemia [WM]) as assessed by the study independent review committee (IRC).~CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.~PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.~For WM only, response was defined as a reduction in IgM of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; plus any reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)"|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set: Enrolled participants who received at least one dose of study medication||percentage of participants||95% Confidence Interval|Number
53461|NCT01282372|Secondary|Mean Sleep Disturbance Subscale Score|The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using safety analysis set defined as all participants who received at least one dose of adalimumab.||Scores on a scale||Standard Deviation|Mean
53462|NCT01282372|Secondary|Mean Visual Analogue Scale (VAS) Score|The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available VAS score at the study time points.||Scores on a scale||Standard Deviation|Mean
53463|NCT01282372|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.||mg/L||Standard Deviation|Mean
53464|NCT01282372|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.||mm/hr||Standard Deviation|Mean
53465|NCT01282372|Secondary|Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero|"Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC."|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.||Percentage of participants|||Number
53466|NCT01282372|Secondary|Mean Psoriatic Arthritis Response Criteria (PsARC) Score|As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The PsARC score was not assessed in this study.|||||
53467|NCT01282372|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available BASDAI score at the study time points.||Scores on a scale||Standard Deviation|Mean
53468|NCT01282372|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available HAQ-DI score at the study time points.||Scores on a scale||Standard Deviation|Mean
53469|NCT01282372|Secondary|Mean Disease Activity Score 28 (DAS28)|The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available DAS28 score at the study time points.||Scores on a scale||Standard Deviation|Mean
53470|NCT01282372|Primary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53471|NCT01282372|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53472|NCT01282372|Primary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53473|NCT01282372|Secondary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53474|NCT01282372|Primary|Mean Change From Baseline in Impairment While Working Due to Health Problem|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53486|NCT01282294|Secondary|Surgeon's Perceived Satisfaction|Surgeons’ perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53497|NCT01282229|Primary|Gain in Clinical Attachment Level of Periodontal Tissues|Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment.|Baseline, 6, 12 months|5-6 mm baseline PD partition had a different sample size than the 7+mm partition.||mm|Participants|Standard Deviation|Mean
53475|NCT01282372|Secondary|Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53476|NCT01282372|Primary|Mean Change From Baseline in Work Time Missed Due to Health Problem|The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53477|NCT01282372|Secondary|Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups|The 'work time missed due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.||Impairment percentage||Standard Deviation|Mean
53478|NCT01282294|Secondary|Time to Full Weight Bearing|The time from surgery to full weight bearing was assessed in days.|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). 3 patients never reached full weight bearing, and 1 dropped out before 6 weeks.||days||Full Range|Median
53479|NCT01282294|Secondary|Patient's Perceived Satisfaction|Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|6 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~Patient satisfaction was completed by 84 patients."||scores on a scale||Standard Deviation|Mean
53480|NCT01282294|Secondary|Pain by Visual Analog Scale (VAS)|Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain.|6 weeks, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53481|NCT01282294|Secondary|Likelihood to Develop a Non-union Assessed by Surgeon|The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53482|NCT01282294|Secondary|Likelihood to Develop Wound Infection Assessed by Surgeon|The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53483|NCT01282294|Primary|Infection Adverse Events|"Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:~superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue~deep incisional SSI, affecting deep soft tissue~organ/ space SSI (Osteomyelitis), affecting joint or bursa"|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||number of events|||Number
53484|NCT01282294|Primary|Functional Outcome: WOMAC|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee.~Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53487|NCT01282294|Secondary|Evidence of Functional Bone Union According to Johnson Classification|"Functional bone union was assessed according to Johnson et al.*:~F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."||participants|||Number
53488|NCT01282294|Secondary|Evidence of Economic Bone Union According to Johnson Classification|"Economic bone union was assessed according to Johnson et al.*:~E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."||participants|||Number
53489|NCT01282294|Secondary|Evidence of Anatomic Bone Union According to Johnson Classification|"Anatomic bone union was assessed according to Johnson et al.*:~A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."||participants|||Number
53490|NCT01282294|Primary|Quality of Life: EQ-5D|The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53491|NCT01282294|Primary|Quality of Life: SF-12 Mental Component Summary (MCS)|"The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.~It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53492|NCT01282294|Primary|Quality of Life: SF-12 Physical Component Summary (PCS)|"The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.~It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).||scores on a scale||Standard Deviation|Mean
53493|NCT01282229|Secondary|Discomfort|Subjects recorded in a diary discomfort on a 10 point visual analog scale daily for the week following treatment. Subjects provided an estimate for each of the four treated quadrants. Zero (0) represents no pain or discomfort and ten (10) represents severe pain and/or discomfort. For each subject discomfort scores on each day from Day 1 to Day 7 were summed. Medians and ranges for each treatment are recorded. The total score could range from 0 to 70.|1-7 days|Subjects with missing data (e.g., missing diary entries) are not included in the analysis.||sum of units on a scale|Participants|Full Range|Median
53494|NCT01282229|Secondary|Change in Gingival Index|The gingival index is a 0-4 unit scale that the examiner uses to estimate the amount of edema and erythema at 2 locations (lingual and buccal) for every tooth in the quadrant. Zero (0) represents no redness and swelling and four (4) represents severe redness and swelling. Negative numbers are a decrease in in examiner estimate of erythema and edema and represent an improvement in clinical outcome.|Baseline, 6, 12 months|||units on a scale from 0-4|Participants|Standard Deviation|Mean
53495|NCT01282229|Secondary|Change in Bleeding on Probing (BOP)|"Percent of pockets within a quadrant that changed from baseline to 6 or 12 months. Negative numbers are a decrease in bleeding on probing which represents clinical improvement.~Each quadrant within the patient represents one of four treatments, the unit of analysis. Pockets are replications within treatments and vary in number among quadrants."|Baseline, 6, 12 months|||percentage of pockets that bled|Participants|Standard Deviation|Mean
53496|NCT01282229|Secondary|Change in Probing Depth (PD)|Positive numbers indicate average decrease in probing depth (improvement).|Baseline, 6, 12 months|||mm|Participants|Standard Deviation|Mean
53499|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists’ length of clinical experience with general anesthesia and modern inhalation agents was collected (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command|All participants with available data at each time point were included in the analysis.||Spearman's correlation coefficient|||Number
53500|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected (see Outcome Measure 15). The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 ( 1 hour after the surgery), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the surgery|All participants with available data at each time point were included in the analysis.||Spearman's correlation coefficient|||Number
53501|NCT01282203|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the creatine kinase myocardial isoenzyme outcome measure.|||||
53502|NCT01282203|Secondary|Cardiac Troponin (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.|||||
53503|NCT01282203|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: Blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia|All participants with valid data were included in the analysis.||Participants|||Number
53504|NCT01282203|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||beats per minute||Standard Deviation|Mean
53505|NCT01282203|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||mm Hg||Standard Deviation|Mean
53506|NCT01282203|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||mm Hg||Standard Deviation|Mean
53507|NCT01282203|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.||mm Hg||Standard Deviation|Mean
53508|NCT01282203|Primary|Patients' Overall Impression of Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: Excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.||Participants|||Number
53509|NCT01282203|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The overall satisfaction of the anesthesiologist with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.||units on a scale||Standard Deviation|Mean
53510|NCT01282203|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.||Minutes||Standard Deviation|Mean
53511|NCT01282203|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command.|All participants with available data were included in the analysis.||Minutes||Standard Deviation|Mean
53512|NCT01282203|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 10 minutes|All participants with available data were included in the analysis.||Minutes||Standard Deviation|Mean
53513|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours|As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants||Units on a scale|Participants|Standard Error|Mean
53514|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours|As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants||Units on a scale|Participants|Standard Error|Mean
57005|NCT01243320|Secondary|Mean Change in Diastolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmhg||95% Confidence Interval|Mean
53515|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected. The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience (exp) with inhalation (inh) anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.|All participants with available data at each time point were included in the analysis.||Spearman's correlation coefficient|||Number
53516|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected. The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 (1 hour after the operation), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||Spearman's correlation coefficient|||Number
53517|NCT01282086|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|All participants with available data were included in the analysis.||U/L||Standard Deviation|Mean
53518|NCT01282086|Secondary|Cardiac Troponin (Troponin T) (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available. No data were reported for this outcome measure during the study.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.|||||
53519|NCT01282086|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia on Day 1|All participants with valid data were included in the analysis.||participants|||Number
53520|NCT01282086|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||beats per minute||Standard Deviation|Mean
53521|NCT01282086|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||mm Hg||Standard Deviation|Mean
53522|NCT01282086|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.||mm Hg||Standard Deviation|Mean
53523|NCT01282086|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n= the number of participants with available data at given time point.||mm Hg||Standard Deviation|Mean
53524|NCT01282086|Primary|Patients' Overall Impression of the Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.||participants|||Number
53525|NCT01282086|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The anesthesiologist's overall satisfaction with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.||units on a scale||Standard Deviation|Mean
53526|NCT01282086|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.||minutes||Standard Deviation|Mean
53527|NCT01282086|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command|All participants with available data were included in the analysis.||minutes||Standard Deviation|Mean
53528|NCT01282086|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 16 minutes|All participants with available data were included in the analysis.||minutes||Standard Deviation|Mean
53529|NCT01281865|Primary|Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)||At 8 weeks|||participants|||Number
53530|NCT01281839|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows mean (standard deviation) of CL values of TMC435. To calculate the mean CL for the study, CL values were derived for each participant at each visit and then the median of CL values across visits for each participant was used to calculate the mean CL for the study.|From the time of administration through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||L/h||Standard Deviation|Mean
75039|NCT01056718|Secondary|Resting Stroke Volume||10 weeks|||ml||Standard Deviation|Mean
53531|NCT01281839|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows mean (standard deviation) of C0h values of TMC435. To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then the median of C0h values across visits for each participant was used to calculate the mean C0h for the study.|Before administration of TMC435 through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng/mL||Standard Deviation|Mean
53532|NCT01281839|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours (AUC 24hr) after dosing for TMC435. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then the median of AUC value across visits for each participant was used to calculate the mean AUC 24 hr for the study.|From the time of administration up to 24 hours after dosing through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||ng*h/mL||Standard Deviation|Mean
53533|NCT01281839|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Weeks||95% Confidence Interval|Median
53534|NCT01281839|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 156 of 260 participants in the TMC435 treatment group and 84 of 133 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to treat population (defined as all participants who were randomized and received at least one dose of study medication).||Percentage of Participants|||Number
53535|NCT01281839|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||Standard Error|Mean
53536|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53537|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows mean time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
53538|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows mean time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
53539|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
53540|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Days||95% Confidence Interval|Median
53541|NCT01281839|Secondary|The Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53542|NCT01281839|Secondary|The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53543|NCT01281839|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53544|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53545|NCT01281839|Secondary|The Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53546|NCT01281839|Secondary|The Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53547|NCT01281839|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53548|NCT01281839|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53549|NCT01281839|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53550|NCT01281839|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53551|NCT01281839|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53552|NCT01281839|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53553|NCT01281839|Secondary|The Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with HCV ribonucleic acid (RNA plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53554|NCT01281839|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels. From Week 4 onwards, most participants in TMC 435 150mg 12Wks PR24/48 group had plasma HCV RNA levels below the limit of detection of the HCV RNA assay.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
53555|NCT01281839|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
53556|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53643|NCT01280591|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53557|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53558|NCT01281839|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of Participants|||Number
53559|NCT01281839|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Percentage of participants|||Number
53560|NCT01281644|Secondary|Patient Self-rated Severity|This outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the patient at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks|||units on a scale|Participants|Inter-Quartile Range|Median
53561|NCT01281644|Primary|Difference in Disease Severity Scores|The primary outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the blinded dermatologists at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. However, raters were trained and calibrated on the use of the scale, and prior to review of study images, were asked to rate archival skin images on the same 4-point qualitative subscales used in the study. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks|||units on a scale|Participants|Inter-Quartile Range|Median
53562|NCT01281501|Secondary|Number of Participants That Have Overall Satisfaction on the Treatment|The satisfaction will be assessed by a simple, self-reported yes/no question.|1 hour after treatment|||participants|||Number
53563|NCT01281501|Secondary|Number of Participants With Adverse Effect|The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.|1 hour after treatment||||||
53564|NCT01281501|Secondary|"Number of Participants in the Predefined Non-responders"|“Non-responders” defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study.|pretreatment and 1 hour after treatment|||participants|||Number
53565|NCT01281501|Secondary|"Number of Participants in the Predefined Responders"|"Responders define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study."|pretreatment and 1 hour after treatment|||participants|||Number
53566|NCT01281501|Primary|Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment|Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as “Non-responders”(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as “Responders” (good outcome).|1 hour after treatment|All enrolled patients were analyzed with the intention-to-treat principles.||millimeter||Standard Deviation|Mean
53567|NCT01281475|Secondary|Presence of Tremors||1 year|||Participants|||Count of Participants
53568|NCT01281475|Primary|Bayley Cognitive Age Equivalent at 1 Year||12 months|||months||Standard Deviation|Mean
53569|NCT01281306|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set: The safety analysis set included all randomized participants who received at least one dose of study medication.||Number of participants|||Number
53570|NCT01281306|Secondary|Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP < 140/90 mmHg. Blood pressure response in msSBP was defined as <140 mmHg or a reduction >= 20mmHg from baseline. Blood pressure response in msDBP was defined as < 90 mmHg or a reduction >= 10 mmHg from baseline.|8 weeks|Only participants of the full analysuis set (FAS), who had week 8 measurements, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||Number of participants|||Number
53571|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were >= 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53644|NCT01280591|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53572|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were leass than 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53573|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were >= 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
53574|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were < 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
53575|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Non-dippers|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53576|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Dippers|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53577|NCT01281306|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53578|NCT01281306|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
53579|NCT01281306|Secondary|Change From Baseline in Nighttime maSBP and maDBP|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline and 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53580|NCT01281306|Secondary|Change From Baseline in Daytime maSBP and maDBP|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53581|NCT01281306|Secondary|Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.||mmHg||Standard Error|Least Squares Mean
53582|NCT01281306|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
53583|NCT01281306|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.||mmHg||Standard Error|Least Squares Mean
53584|NCT01281202|Secondary|Number of Participants With Cocaine Use||Week 3 - 9|||participants|||Number
53585|NCT01281202|Primary|Abstinence|The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).|Weeks 8-9|||participants|||Number
53586|NCT01281124|Secondary|Progression-free Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.|||||
53587|NCT01281124|Secondary|Overall Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.|||||
53588|NCT01281124|Primary|DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29|The change in mean methylation of the genes between the patients with a low mir29 and a high mir29 expression will be evaluated by a two-sample t-test. Secondary analyses include a multivariate regression where all 5 changes in methylation will be regressed on mir29 expression (low vs. high) and adjusted for patient demographic and clinical attributes at baseline.|Up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.|||||
53589|NCT01281007|Secondary|Safety Will be Evaluated by the Adverse Events Occurence|Adverse events will be collected and followed in order to evaluate safety and tolerability|Day 5||||||
53590|NCT01281007|Primary|Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation|Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.|Day 5|||subjects|||Number
53591|NCT01280981|Secondary|Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9|The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization|Month 9|Intent to treat participants who had an electrocardiogram (ECG) at month 9||milliseconds||Standard Deviation|Mean
53592|NCT01280981|Secondary|Mean Intraocular Pressure at Month 9|Mean intraocular pressure at month 9 or the early termination visit.|Day 1 up to Month 9|Intent to treat participants who had ophthalmic exams.||mmHg||Standard Deviation|Mean
53593|NCT01280981|Secondary|Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment|Participants whose laboratory examinations (hematology, blood chemistry and urinalysis) were considered by the investigator to be treatment emergent adverse experiences (TEAE) and related to treatment. Also indicated is whether the TEAE lab parameter caused the participant to discontinue from the study.|Day 1 to up to Month 9|Intent to treat population||participants|||Number
53594|NCT01280981|Secondary|Mean Blood Pressure Measurements at Week 36|Mean systolic and diastolic blood pressure measurements taken at week 36|approximately week 36|Intent to treat population of participants with week 36 blood pressure data.||mmHg||Standard Deviation|Mean
53595|NCT01280981|Secondary|Participants With Abnormal Gynecological Examinations|Participants with abnormal gynecological examination findings based on endometrial biopsies and transvaginal ultraonogrphy (TVU) are summarized. Clinically significant results from the endometrial biopsies are results that are not benign. Abnormalities found during transvaginal ultrasonography (TVU) are detailed in the AE listings. Please refer to AE listings.|Day 1 to up to Month 9|Intent to treat population||participants|||Number
53596|NCT01280981|Primary|Participants With Treatment-Emergent Adverse Events (AEs)|Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.|Day 1 to up to Month 9|Intent to treat population (ITT)||participants|||Number
53597|NCT01280968|Primary|Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff||measured at week 1 and week 16|||percentage of change||Standard Error|Mean
53598|NCT01280968|Primary|Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16|||percentage of change||Standard Error|Mean
53599|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16|||percentage of change||Standard Error|Mean
53600|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16|||percentage of change||Standard Error|Mean
53601|NCT01280955|Secondary|Incidence of Grade II/IV Acute Graft Versus Host Disease|Weekly through Day 100 post transplant|100 days||||||
53602|NCT01280955|Secondary|Plasma Cytokines/Chemokines|As determined by IL-12, IFN-gamma, TNF-alpha and macrophage inhibitory protein-1 measured at day +7, +14 and +30.|1 month||||||
53603|NCT01280955|Secondary|Immunological Reconstitution|As determined by CD4 count, CD8 count, NK cells, B cells and Immunoglobulin level on day +30, 60+, and +90|90 days||||||
53604|NCT01280955|Secondary|Transplant Related Mortality Calculated at Day +100||100 Days Post Transplant|||participants||95% Confidence Interval|Number
53605|NCT01280955|Primary|Plerixafor-associated Adverse Events||100 Days Post Transplant|||number of adverse events|||Number
53606|NCT01280955|Primary|Time to Platelet Recovery|platelet > 20,000/ul on 2 consecutive days|100 Days Post Transplant|participants who completed study.||days||95% Confidence Interval|Median
53607|NCT01280955|Primary|Time to Neutrophil Recovery|leukocytes > 500/ul on 2 consecutive days|100 Days post Transplant|participants who completed study.||days||95% Confidence Interval|Median
53608|NCT01280695|Secondary|Change From Baseline in High Molecular Weight Adiponectin|To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||ng/mL||Standard Error|Least Squares Mean
53609|NCT01280695|Secondary|Change in Fasting Plasma Insulin|To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days|Baseline and 28 days|The Per-Protocol population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||µIU/mL||Standard Deviation|Least Squares Mean
53610|NCT01280695|Secondary|Change From Baseline in Hematocrit|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||Change from baseline||Standard Error|Least Squares Mean
61186|NCT01195090|Secondary|Baseline Triglyceride (TG)|Baseline TG|Baseline|Baseline TG||mg/dl||Standard Deviation|Mean
53611|NCT01280695|Secondary|Change From Baseline in Body Weight|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||kg||Standard Error|Least Squares Mean
53612|NCT01280695|Secondary|Change From Baseline in HbA1c|To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.||percentage of hemoglobin||Standard Error|Least Squares Mean
53613|NCT01280695|Primary|Change From Baseline in Fasting Plasma Glucose|To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|Per-Protocol Population:Included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures. The Per-Protocol Population was used for all efficacy measurements.||mg/dL||Inter-Quartile Range|Median
53614|NCT01280656|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||participants|||Number
53615|NCT01280656|Secondary|Percentage of Participants Who Discontinued Treatment Due to Adverse Events|The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
53616|NCT01280656|Secondary|Percentage of Participants With Null Response or No Responder at End of Treatment|Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
53617|NCT01280656|Secondary|Percentage of Participants With Virologic Relapse up to Week 72|Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).||percentage of participants|||Number
53618|NCT01280656|Secondary|Percentage of Participants With Virologic Response at End of Treatment|Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
53619|NCT01280656|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.|At Week 4|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
53620|NCT01280656|Secondary|Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders|The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.||mean percentage reduction of hemoglobin||Standard Deviation|Mean
53621|NCT01280656|Secondary|Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment|The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)||percentage of participants|||Number
53622|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home|The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.|At Week 60 (SVR 12) and Week 72 (SVR 24)|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group excluding participants treated at an unknown location (2/16, 5/126, and 9/101 respectively).||percentage of participants|||Number
53623|NCT01280656|Secondary|Percentage of Participants With Early Virologic Response at Week 12|An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.|At Week 12|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.||percentage of participants|||Number
53624|NCT01280656|Secondary|Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used|The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported|At Week 24|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).||participants|||Number
53625|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment|SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).||percentage of participants|||Number
53626|NCT01280656|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment|Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants’ plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 60|The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).||percentage of participants|||Number
53627|NCT01280604|Secondary|Serum Creatinine(SCr)|SCr levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
53628|NCT01280604|Secondary|Aspartate Aminotransferase (AST)|AST levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||international units/liter||Standard Deviation|Mean
53629|NCT01280604|Secondary|Alanine Aminotransferase(ALT)|ALT levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||international units/liter||Standard Deviation|Mean
53630|NCT01280604|Secondary|High-density Lipoprotein,(HDL)|HDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
53631|NCT01280604|Secondary|Low-density Lipoprotein (LDL)|LDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
53632|NCT01280604|Primary|Triglyceride Levels|Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks|||milligram/deciliter||Standard Deviation|Mean
53633|NCT01280591|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53634|NCT01280591|Secondary|Cumulative Proportion of Subjects Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population||participants|||Number
53635|NCT01280591|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
53636|NCT01280591|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53637|NCT01280591|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
53638|NCT01280591|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
53639|NCT01280591|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Minutes||Standard Deviation|Mean
53640|NCT01280591|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
53641|NCT01280591|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Scores on a scale||Standard Deviation|Mean
53680|NCT01279447|Primary|Post op Pain Score|immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.|0 hours|||units on a scale||Standard Deviation|Mean
81499|NCT00989157|Secondary|Emesis|episodes of emesis.|4 days|||number of occurences|||Number
53646|NCT01280591|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53647|NCT01280591|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53648|NCT01280591|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53649|NCT01280591|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
53650|NCT01280591|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
53651|NCT01280591|Secondary|Total Sleep Time Measured by Actigraphy|Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
53652|NCT01280591|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
53653|NCT01280591|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
53654|NCT01280552|Secondary|Progression Free Survival in HLA- A2 Patients|"Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype.~Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed"|2-3 yers|HLA-A2 patients||months of progression free survival||95% Confidence Interval|Median
53655|NCT01280552|Primary|Overall Survival in HLA-A2 Patients|Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.|2-3 years|Patients with HLA-A2 haplotype||months of survival||95% Confidence Interval|Median
53656|NCT01280552|Secondary|PFS|"Secondary Endpoints~PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed.~Population is all randomized patients ITT."|2-3 years|Intent to treat includes all randomized patients||months of progression free survival||95% Confidence Interval|Median
53657|NCT01280552|Primary|Overall Survival (OS)|The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis|2 -3 years|Intent to treat include all randomized patients||months of survival||95% Confidence Interval|Median
53658|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, maternal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
53659|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, fetal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
53681|NCT01279317|Primary|Postprandial Glycemic Incremental Area Under the Curve|area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages|2 hr|all subjects completed study and are included in analysis||mmol/L / 2hr||Standard Error|Mean
54060|NCT01274559|Primary|Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53660|NCT01280357|Secondary|The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM|During labor and delivery uterine contractions were measured between the Monica AN24 & the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement|between 35 mins & 15hrs during first & second stage labor|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in FDA 6 way trial for Fetal Heart Rate (FHR) and Uterine Activity (UA) 2 participants were used in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"||Positive Percentage Agreement (PPA)||95% Confidence Interval|Mean
53661|NCT01280266|Secondary|Dorsal-digital-difference.|The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.|baseline and 4 weeks|||degree celcius.||Standard Deviation|Mean
53662|NCT01280266|Secondary|Time-averaged Peak Velocity (cm/Sec)|changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.|baseline and 4 weeks|||cm/sec||Standard Deviation|Mean
53663|NCT01280266|Secondary|Change in Peak Systolic Flow (cm/Sec)|"Change in digital artery flow velocity in proper palmar digital artery in cm/sec.~0-unlimited"|baseline and 4 weeks|||cm/sec||Standard Deviation|Mean
53664|NCT01280266|Secondary|Change in Digital Ulcer Number|0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.|baseline and 4 weeks|||Digital ulcers||Standard Deviation|Mean
53665|NCT01280266|Secondary|Change in Physician's Global Assessment on Visual Analogue Scale (VAS)|"Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline.~negative value (decrease in value) means improvement."|at 0 (baseline) and 4 weeks (after treatment)|||units on a scale||Standard Deviation|Mean
53666|NCT01280266|Secondary|Change in Health Assessment Questionnaire (HAQ)|Ordinal scale 0-10 0 good 10 bad|0 and 4 weeks|||units on a scale||Standard Deviation|Mean
53667|NCT01280266|Secondary|Change in the RP Duration|Change in the average RP duration in minutes (min) per attack. 0 -- unlimited|baseline and 4 weeks|||min per attack||Standard Deviation|Mean
53668|NCT01280266|Secondary|Change in Raynaud's Condition Score (RCS)|"change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20).~Range 0-10 ordinal scale 0..good 10.. bad"|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
53669|NCT01280266|Primary|RP Attacks Per Day|Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.|baselin and 4 weeks|14 patients in UA arm + 12 patients in AU arm||attacks per day||Standard Deviation|Mean
53670|NCT01280123|Secondary|Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks|The Geriatric Depression Scale - 15 is a short 15 yes or no question instrument for assessing depression in the elderly. It has been found to be particularly useful in assessing depression in Parkinson's Disease. A score of 0 to 5 is normal. A score greater than 5 suggests depression.|44 weeks|||units on a scale||95% Confidence Interval|Mean
53671|NCT01280123|Secondary|Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks|The Mattis dementia rating scale is a psychometric instrument designed to assess the extent and nature of dementia. Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better.|44 weeks|||units on a scale||95% Confidence Interval|Mean
53672|NCT01280123|Secondary|Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks|"The Parkinson's Disease Questionnaire (PDQ-39) is a short, 39 item measure of quality of life in subjects with Parkinson's disease. The questionnaire covers 8 aspects of quality of life: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort.~The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life."|44 weeks|||units on a scale||95% Confidence Interval|Mean
53673|NCT01280123|Secondary|Change in Schwab and England Scale From Baseline to 44 Weeks|The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative).|44 weeks|||units on a scale||95% Confidence Interval|Mean
53674|NCT01280123|Secondary|Change in Ambulatory Capacity From Baseline to 44 Weeks|"This is the sum of the 5 UPDRS questions regarding ambulatory capacity: falling, freezing, walking, gait, postural stability.~Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. Change is 44 weeks - baseline."|44 weeks|||units on a scale||95% Confidence Interval|Mean
53675|NCT01280123|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks|"Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day).~The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.~The change is 44 weeks - baseline."|44 weeks|||units on a scale||Standard Error|Mean
53676|NCT01280110|Secondary|Macular Thickness|Macular thickness will be measured with an Optical coherence tomography (OCT). Measures 5% under the normal population according to the OCT software will be considered break in the blood-retina barrier.|Baseline, 15 days and 30 days.|Statiscal power of 80%||μm||Standard Deviation|Mean
53677|NCT01280110|Primary|Aqueous Humor Flare|Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.|Baseline, 15 days and 30 days.|Statiscal power of 80%.||photons/msec||Standard Deviation|Mean
53678|NCT01279564|Primary|Duration of Endotracheal Intubation|Time between introducing the laryngoscope and inflation of tube's cuff|The induction of general anesthesia, on the operating day (first day)|||seconds||Standard Deviation|Mean
61759|NCT01191242|Primary|Total EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
53682|NCT01279265|Secondary|Fecal Calprotectin|Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.|90 days|||µg/g (feces)||95% Confidence Interval|Mean
53683|NCT01279265|Secondary|Fecal Microbiota|Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.|90 days|||Shannon's diversity index value||Standard Deviation|Mean
53684|NCT01279265|Primary|Daily Average Crying and Fussing Duration According to Barr Diary Records|The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.|90 days|||minutes||95% Confidence Interval|Mean
53685|NCT01279200|Primary|Pregnancy Success Rate|Percentage of women in each arm who became pregnant within the study time frame.|3 menstrual/treatment cycles (approximately 28-33 days each)|||percentage of participants|||Number
53686|NCT01279200|Secondary|Time to Conception, Measured in Cycles|Cycles means treatment/menstrual cycles, approximately 28-33 days.|3 menstrual/treatment cycles, or upon conception, whichever comes first|Numbers of participants analyzed changes from 8 with kits and 4 with ultrasound (enrolled) because time to conception can be measured only for those who conceived, so the 6 and 1 participants analyzed here are those who were successful in getting pregnant.||menstrual cycles||Full Range|Mean
53687|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30–max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 40 weeks|||units on a scale||Standard Deviation|Mean
53688|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30–max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 16 weeks|||units on a scale||Standard Deviation|Mean
53689|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39–max. 156) with a higher score indicating a better result.~The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0–max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
53690|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39–max. 156) with a higher score indicating a better result.~The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0–max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 16 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
53691|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.~12–max. 129). A higher score indicates better performance."|Change from baseline in executive functioning at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
53708|NCT01278927|Primary|Functional Status|To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days|||units on a scale||Standard Deviation|Mean
53758|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage of subjects|||Number
53692|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgment, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.~12–max. 129). A higher score indicates better performance."|Change from baseline in executive function at 16 weeks (post-treatment)|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.||units on a scale||Standard Deviation|Mean
53693|NCT01279044|Secondary|Number of Condom-protected Anal Intercourse Events|"The outcome measure data shows the rate of change in the mean value of the number of condom-protected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.~Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months|||Self reported behavior in past 3 months|||Number
53694|NCT01279044|Secondary|Number of Receptive UAI Events|"The outcome measure data shows the rate of change in the mean value of the number of receptive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Self reported behavior in past 3 months|||Number
53695|NCT01279044|Secondary|Number of Instertive UAI Events|"The outcome measure data shows the rate of change in the mean value of number of instertive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Self reported behavior in past 3 months|||Number
53696|NCT01279044|Secondary|Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events|"The outcome measure data shows the rate of change in the mean value of number of serodiscordant unprotected anal intercourse events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.~Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months|||Events in past 3 months|||Number
53697|NCT01279044|Primary|Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse episodes with three most recent sex partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Episodes in past 3 months|||Number
53698|NCT01279044|Primary|Total Unprotected Anal Intercourse Partners|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Partners in past 3 months|||Number
53699|NCT01279044|Primary|Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)|"The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months|||Self reported events in past 3 months|||Number
53700|NCT01278953|Primary|Incidence of Device-related Early-onset Primary Serious Adverse Events|Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.|12 months|||participants|||Number
53701|NCT01278953|Primary|Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter|Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.|12 months|||participants|||Number
53702|NCT01278927|Secondary|Survival|Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.|6 months and 1 year|||percentage of participants||95% Confidence Interval|Number
53703|NCT01278927|Secondary|SF-36 Late Outcomes|The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|6 months|||units on a scale||Standard Deviation|Mean
53704|NCT01278927|Secondary|Days of Hospitalization|The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.|100 days|||days||Standard Deviation|Mean
53705|NCT01278927|Secondary|Nausea|Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.|100 days|||units on a scale||Standard Deviation|Mean
53706|NCT01278927|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.|100 days|||units on a scale||Standard Deviation|Mean
53707|NCT01278927|Secondary|Cancer and Treatment Distress (CTXD)|Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.|100 days|||units on a scale||Standard Deviation|Mean
53709|NCT01278927|Secondary|Symptoms|Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days|||units on a scale||Standard Deviation|Mean
53710|NCT01278797|Secondary|Time of Maximum Concentration of Amlodipine (TMAX)|Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial||hours||Standard Deviation|Mean
53711|NCT01278797|Primary|Maximum Observed Plasma Concentration (Cmax) of Amlodipine||Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial||nanograms/milliliter||Standard Deviation|Mean
53712|NCT01278797|Primary|Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)|Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial||nanograms*hour/milliliter||Standard Deviation|Mean
53713|NCT01278615|Primary|Disease Control Rate (Complete Response [CR], Partial Response [PR], and Stable Disease [SD]) in Patients Treated With Selumetinib|Estimates of the disease control rate with the exact two-sided 95% confidence intervals. Response was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586. Using these criteria, ‘disease control rate’ encompassed patients who had either a CR, PR, and SD.|Up to 3 years|||percentage of disease control||95% Confidence Interval|Number
53714|NCT01278615|Secondary|Time to Treatment Failure|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from study entry to treatment failure, defined as lymphoma progression or withdrawal from treatment due to adverse events, assessed up to 3 years. Patients who die without progression while still on therapy will be censored as of the time of death.|||days||95% Confidence Interval|Mean
53715|NCT01278615|Secondary|Progression-free Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 years|||days||95% Confidence Interval|Median
53716|NCT01278615|Secondary|Overall Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-death and the corresponding two-sided 95% confidence intervals will be provided.|Date of study entry to the date of death, assessed up to 3 years|||days||95% Confidence Interval|Median
53717|NCT01278615|Secondary|Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Percentage of patients experiencing any grade 3 or higher adverse event at least possibly attributed to the study drug. (Additional adverse event reporting will appear in the AE outcomes module.)|Up to 3 years|||percentage of participants||95% Confidence Interval|Number
53718|NCT01278615|Secondary|Duration of Response|The Kaplan-Meier procedure will be used to characterize the duration of response. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 years|Zero participants were analyzed due to no response.|||||
53719|NCT01278615|Primary|Response Rate (Complete Response [CR] and Partial Response [PR]) in Patients Treated With Selumetinib|Estimates of the response rate based on best response (CR and PR) with the exact two-sided 95% confidence intervals. Response for this lymphoma clinical study was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586.|Up to 3 years|||percentage of response||95% Confidence Interval|Number
53720|NCT01278485|Secondary|Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment|On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always.|Up to 12 Months Prior to Enrollment|All enrolled participants that completed the fear of weight gain questionnaire.||Score on a Scale||Standard Deviation|Mean
53721|NCT01278485|Secondary|Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment|Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable.|Up to 12 Months Prior to Enrollment|All enrolled participants||Participants|||Number
53722|NCT01278485|Secondary|Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment|Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia.|Day of Enrollment|All enrolled participants that completed the worry scale of the HFS II.||Score on a Scale||Standard Deviation|Mean
53723|NCT01278485|Primary|Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment|Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Day of Enrollment|All enrolled participants with a hemoglobin A1c measurement collected on the day of enrollment.||Participants|||Number
53736|NCT01278394|Secondary|Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 90|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
53724|NCT01278485|Secondary|Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment|The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never.|Day of Enrollment|All enrolled participants that completed a questionnaire on the day of enrollment.||Score on a Scale||Standard Deviation|Mean
53725|NCT01278485|Secondary|Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment|The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life.|Day of Enrollment|All enrolled participants that completed the TSQM on the day of enrollment.||Score on a Scale||Standard Deviation|Mean
53726|NCT01278485|Secondary|Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment|Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health).|Day of Enrollment|All enrolled participants with a completed EQ-VAS questionnaire.||Score on a Scale||Standard Deviation|Mean
53727|NCT01278485|Secondary|Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment|The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Day of Enrollment|All enrolled participants with a completed EQ-5D questionnaire.||Score on a Scale||Standard Deviation|Mean
53728|NCT01278485|Primary|Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment|At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.|Up to 6 Months Prior to Enrollment|All enrolled participants that experienced hypoglycemia in the prior 6 months.||Participants|||Number
53729|NCT01278485|Primary|Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment|The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.|Up to 6 Months Prior to Enrollment|All enrolled participants.||Participants|||Number
53730|NCT01278407|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score|The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, supplemented by 2 dementia with Lewy bodies (DLB)-relevant domains of sleep, and cognitive fluctuation [reported as cognitive fluctuation inventory]) were assessed. The score of each item was calculated as frequency (scale: 1=occasionally to 4=very frequently) x Severity (scale: 1=Mild to 3=Severe). The NPI-2 was calculated as the sum of the scores for hallucinations and cognitive fluctuation, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicated improvement. Data are presented as change from baseline in mean NPI-2 +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.||Units on a scale||Standard Deviation|Mean
53731|NCT01278407|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. Data are presented as change from baseline in mean MMSE +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.||Units on a scale||Standard Deviation|Mean
53732|NCT01278394|Secondary|Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG|Length of time to clinical evaluation of clear or at least 5 mm of CNG.|Baseline to 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||days||95% Confidence Interval|Mean
53733|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
53734|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 270|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
53735|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 180|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||participants|||Number
53737|NCT01278394|Secondary|Clear Nail Growth of the Targeted Toenail|Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.||millimeters||95% Confidence Interval|Mean
53738|NCT01278394|Primary|Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360|Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the last observation was carried forward (LOCF) to impute missing observations.||participants|||Number
53739|NCT01278342|Secondary|The Percentage of Participants With Partial Response (PR) at 8 Months|"Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.~Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range.~Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR||percent||95% Confidence Interval|Number
53740|NCT01278342|Secondary|The Percentage of Participants With Complete Response (CR) At 3 Months|"A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:~Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and~IGF-I within the Central Laboratory Normal Range (for age and gender)"|From Baseline to 3 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR||percent||95% Confidence Interval|Number
53741|NCT01278342|Primary|The Percentage of Participants With Complete Response (CR) at 8 Months|"A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:~Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and~IGF-I within the Central Laboratory Normal Range (for age and gender)."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR||percent||95% Confidence Interval|Number
53742|NCT01278303|Secondary|Secondary Safety Outcomes - Adverse Events|"Secondary Safety Outcomes~The proportion of patients experiencing any serious or somewhat serious adverse event related to the stent or implant procedure by 24 months follow up, such as: new aortic wall injury within the region of covered CP Stent implantation, stent malposition, stent fracture, aortic wall aneurysms (early or late), or restenosis requiring reintervention, arterial access site injury, bleeding, etc."|2 years|||percentage of participants|||Number
53743|NCT01278303|Secondary|Secondary Efficacy Outcomes - 1 Year|"Secondary Efficacy Outcomes~At One Year: (A) Number of participants with arm-leg systolic blood pressure (SBP) differences <15 mmHg and (B) Number of participants with normal or only mildly elevated SBP, no more than mild arm-leg SBP, no clinically significant residual aortic wall injury AND no worsening in any of these three categories"|1 years|||participants|||Number
53744|NCT01278303|Primary|Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening|"Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up~SIS is divided into 3 conditions & 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- > 159 mmHg or any hpn on >2 medications 3- 140-159 mmHg or elevated SBP on >2 medications 4- 130-139 mmHg or normal SBP on >2 medications 5- <130 mmHg on 0-2 meds~C2 Upper Extremity to Lower Extremity SBP difference 2- >59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- <15 mmHg~C3~Aortic Wall Injury severity levels:~Uncontained rupture or large aneurysm~Contained rupture or stable large aneurysm~Small contained rupture or moderate aneurysm~Acute, but stable AWI or small aneurysm~No injury or minor aortic wall irregularity not in need of treatment.~Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy"|Baseline and 12 months|Participants available for analysis at one year||participants|||Number
53745|NCT01277211|Secondary|Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle|Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.||Percentage of participants|||Number
53746|NCT01277211|Secondary|Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle|"Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING."|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.||Percentage of participants|||Number
53747|NCT01277211|Primary|Pearl Index, by Treatment Group|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).|Up to 1 year|Restricted Intent-to-Treat (R-ITT) Group, which consisted of all participants from the Intent-to-Treat (ITT) Group who had at least one cycle at risk (no condom use and confirmed intercourse).||Pregnancies per 100 woman-years||95% Confidence Interval|Mean
53748|NCT01277081|Secondary|Overall Cold Symptoms Score|Overall cold symptom score was assessed by asking the question “my cold symptoms are improved” only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’.|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||Standard Error|Mean
54279|NCT01271803|Primary|Cmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
53749|NCT01277081|Secondary|Soothing Attribute Scores|Soothing attribute of test treatment was assessed by asking the question “if the hot drink is soothing” at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’.|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||Standard Deviation|Mean
53750|NCT01277081|Secondary|Cold Symptoms Score Post 60 Minutes|A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. “My head feels clear”, “I feel soothing in my throat” and “I feel my cough is being soothed”. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||95% Confidence Interval|Mean
53751|NCT01277081|Secondary|Cold Symptoms Score Post 15 Minutes|A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. “My head feels clear”, “I feel soothing in my throat” and “I feel my cough is being soothed”. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 15 minutes|ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||95% Confidence Interval|Mean
53752|NCT01277081|Secondary|Breathing Score Post 60 Minutes|A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. “my breathing feels easy”, “I feel airways are open”, “I feel a cooling sensation in my throat”, “I can feel the air flowing to my lungs easily”, “My nose feels less blocked” and “I feel my breathing is comfortable”. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 60 minutes|ITT population: All randomized participants who had at least one post-baseline efficacy evaluation.||Score on a scale||95% Confidence Interval|Mean
53753|NCT01277081|Primary|Breathing Scores Post 15 Minutes|A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. “my breathing feels easy”, “I feel airways are open”, “I feel a cooling sensation in my throat”, “I can feel the air flowing to my lungs easily”, “My nose feels less blocked” and “I feel my breathing is comfortable”. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 15 minutes|Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation.||Score on a Scale||95% Confidence Interval|Mean
53754|NCT01278173|Primary|Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)|Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of IMP and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).||µm||Standard Deviation|Mean
53755|NCT01278173|Primary|Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)|Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of investigational medicinal product and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).||dB||Standard Deviation|Mean
53756|NCT01278160|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).|Weeks 0-16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||episodes|||Number
53757|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage of subjects|||Number
53977|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percent||Standard Deviation|Mean
53759|NCT01278160|Secondary|9-point SMPG (Self Measured Plasma Glucose) Profile|A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||mmol/L||Standard Error|Least Squares Mean
53760|NCT01278160|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline||Week 0, week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). Six patients discontinued trial without any post randomisation HbA1c measurements.||percentage of glycosylated haemoglobin||Standard Deviation|Least Squares Mean
53761|NCT01278030|Primary|Responder Rate|The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.|At 6 month follow-up|Patients who completed the 6 month follow-up with implant 3D echo data.||percentage of participants|||Number
53762|NCT01277861|Secondary|Coughing|Data include patients who coughed irrespective of the degree of coughing.|Intraoperative period|Per protocol||Participants, number|||Number
53763|NCT01277861|Secondary|Apnea|Apnea defined as no breathing for at least 30 s.|Induction of Anesthesia|Per protocol||Participants, number|||Number
53764|NCT01277861|Primary|Movement|The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).|Induction of Anesthesia|Per protocol||Participants, number|||Number
53765|NCT01277822|Secondary|Change From Baseline in Ankle Circumference at Week 8|Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.|Baseline and Week 8|All participants who received at least 1 dose of study drug and had available data for ankle circumference.||mm||Standard Deviation|Mean
53766|NCT01277822|Secondary|Percentage of Participants Who Had Peripheral Edema During the Study|A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.|up to 8 weeks|Safety Set defined as all participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
53767|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 4|Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||Percentage of Participants|||Number
53768|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 8|Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||Percentage of Participants|||Number
53769|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4|Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
53770|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
53771|NCT01277822|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4|Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
53772|NCT01277822|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.||mmHg||Standard Deviation|Mean
53793|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.||percentage of participants|||Number
53773|NCT01277757|Primary|Number of Participants With Objective Response|Only those participants who have measurable disease present at baseline, have received at least four doses of MK2206, and have had their disease re-evaluated will be considered evaluable for response. Response classified according the RECIST definitions, and re-evaluated for response every 12 weeks. (Note: Participants who exhibit objective disease progression prior to receiving four doses of therapy will also be considered evaluable.) In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response, and then revert to scheduled repeat imaging.|4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.||participants|||Number
53774|NCT01277757|Secondary|Apoptosis Assessed by Cleaved Caspase-3|Assessment of apoptosis by immunohistochemistry to active caspase-3.|Up to 30 days after completion of study treatment, up to 1 year||||||
53775|NCT01277757|Secondary|Cell Proliferation as Measured by the Change in Percent Ki-67 Positive Cells|Ki-67 will be scored as % positive cells to determine whether there is a change % Ki-67+ cells before treatment versus after 2 weeks of treatment.|Baseline to 2 weeks||||||
53776|NCT01277757|Secondary|Median Response Duration|"The duration of the response is from the time response is achieved until disease progression is detected. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.~Response re-evaluated every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response."|Response assessment 4 weeks from beginning of treatment, response recorded from the start of treatment until disease progression/recurrence, up to 1 year|Two participants were not treated, and one was inevaluable.||months||Full Range|Median
53777|NCT01277757|Secondary|6 Month Progression-free Survival (PFS)|Number of participants progression free at 6 months. PFS is defined as the duration of time from start of treatment, or time of progression or death, whichever occurs first. The PFS for this outcome was assessed at 6 months post treatment.|From start of treatment to time of progression or death or six months whichever occurs first, assessed at 6 months|||participants|||Number
53778|NCT01277757|Primary|Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)|Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Up to 3 weeks after completion of study treatment, for up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.||participants|||Number
53779|NCT01277718|Primary|Maximum Observed Concentration of Cobimetinib||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
53780|NCT01277718|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
53781|NCT01277601|Secondary|Percentage of Participants Who Required Retreatment|Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.|Up to 120 weeks|Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.||percentage of participants|||Number
53782|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 120|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
53783|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 96|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
57006|NCT01243320|Secondary|Change Systolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmhg||95% Confidence Interval|Mean
53784|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 72|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
53785|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
53786|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
53787|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
53788|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 120|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Baseline; Week 120|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.||percentage of participants|||Number
53789|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 96|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Baseline; Week 96|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.||percentage of participants|||Number
53790|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 72|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Baseline; Week 72|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.||percentage of participants|||Number
53791|NCT01277601|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120|"HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120."|Baseline; Weeks 72, 96, and 120|Full Analysis Set||percentage of participants|||Number
53792|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Weeks 96 and 120|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis."|Baseline; Weeks 96 and 120|Full Analysis Set||percentage of participants|||Number
53817|NCT01277510|Secondary|Growth Velocity From End of Double-blind Phase to End of Open-label Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.|End of double-blind phase (Week 30) until end of the open-label phase (Week 60)|Full analysis set. Only participants with available data were included in the anaysis.||cm/year||Standard Deviation|Mean
53794|NCT01277601|Primary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.||percentage of participants|||Number
53795|NCT01277549|Primary|CD34+ Cell Collection Efficiency|The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.|one day|Results are given for all per protocol subjects.||% of processed CD34+ cells collected||Full Range|Median
53796|NCT01277549|Secondary|Viability of the Collected MNC Product|The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.|One day|Per Protocol||percentage of total WBCs collected||Full Range|Median
53797|NCT01277549|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.|One day|Results given for all per protocol subjects.||percentage of WBCs collected||Full Range|Median
53798|NCT01277549|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.|One Day|Per protocol||RBC % of product volume||Full Range|Median
53799|NCT01277549|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|One Day|Per protocol||% of processed platelets collected||Full Range|Median
53800|NCT01277549|Primary|Mononuclear Cell Collection Efficiency|The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|One day|Results are given for all per protocol subjects.||% of processed MNCs that were collected||Full Range|Median
53801|NCT01277523|Secondary|Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests|Clinically relevant abnormalities for physical examination, ECG, vital signs and laboratory tests. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From first drug administration until 30 days after last drug intake, up to 142 days|Treated set which included all randomised patients who were dispensed and received, at least one documented dose of trial medication.||percentage of participants|||Number
53802|NCT01277523|Secondary|Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.|Time in days to first asthma exacerbation during the 12 week treatment period. The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.||participants|||Number
53803|NCT01277523|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.|"Time in days to first severe asthma exacerbation during the 12 week treatment period. The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values.~A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required an initiation of treatment with systemic corticosteroids for at least 3 days or, in case of ongoing and pre-existing systemic corticosteroid therapy, requiring at least doubling of previous daily doses of systemic corticosteroids for at least 3 days."|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.||participants|||Number
53804|NCT01277523|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.~Measured values presented are actually adjusted means"|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
53805|NCT01277523|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
53806|NCT01277523|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 12.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.||Number of puffs of rescue medication||Standard Error|Mean
53816|NCT01277510|Secondary|Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; only participants with available data were included in the analysis.||percent change||95% Confidence Interval|Least Squares Mean
83866|NCT00966186|Primary|Success of Insertion at First Attempt||5 minute|||participants|||Number
53807|NCT01277523|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ total score responders.~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data for patients not withdrawn from the study were either categorised as no change or based on available data. Withdrawn patients were imputed based upon discontinuation reason.||percentage of participants|||Number
53808|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 12.~The ACQ is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||units on a scale||Standard Error|Mean
53809|NCT01277523|Secondary|ACQ6 Score Responders|"Responder rates based on the ACQ6 score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline <= -0.5), no change (-0.5 < change from trial baseline <0.5) and worsening (change from trial baseline >= 0.5).~The ACQ is a scale containing 7 questions, each question has a 7- point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 is calculated as the mean of the responses to the first 6 questions of the ACQ6.~No statistical testing was performed on ACQ6 responders."|12 weeks|"Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.~Missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason."||percentage of participants|||Number
53810|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ6 Score.|"Change from baseline in Asthma Control Questionnaire (ACQ) 6 score measured at week 12~The ACQ is a scale containing 7 questions, each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ6.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||units on a scale||Standard Error|Mean
53811|NCT01277523|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||litres||Standard Error|Mean
53812|NCT01277523|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC 0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
53813|NCT01277523|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak0–3h) after 12 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||Litres||Standard Error|Mean
53814|NCT01277523|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||litres||Standard Error|Mean
53815|NCT01277523|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.||litres||Standard Error|Mean
54280|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 1, Cycle 1 of Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Standard Deviation|Mean
53818|NCT01277510|Secondary|Growth Velocity From Baseline to End of Double-blind Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.|From Baseline to end of Efficacy Assessment at Week 30|Full analysis set; the last assessment in the double-blind phase was used due to the early termination of the study. Only participants with available data are included in the analysis.||cm/year||95% Confidence Interval|Least Squares Mean
53819|NCT01277510|Secondary|Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks|Full analysis set||percent change||95% Confidence Interval|Least Squares Mean
53820|NCT01277510|Secondary|Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; data for one participant in the Placebo group were not available.||percent change||95% Confidence Interval|Least Squares Mean
53821|NCT01277510|Secondary|Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period|"Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set||percent change||95% Confidence Interval|Least Squares Mean
53822|NCT01277510|Secondary|Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30|Full analysis set||pecentage of participants|||Number
53823|NCT01277510|Primary|Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30|Full analysis set, which includes all randomized participants with at least 1 post-baseline assessment.||percentage of participants|||Number
53824|NCT01277354|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS will be used in the diagnosis of PTSD, assessment of the impact of symptoms on function, assessment of the severity of symptoms at baseline, and weekly throughout the study. The CAPS in this particular study must decrease by 50% for CPT to be deemed effective.|6 weeks|Please note that there were only a total of 2 participants involved in this study. Funding was lost to continue and the study was terminated. Though CAPS data was reviewed from these 2 participants, data was never statistically analyzed since the project ended and had no follow-up plan.|||||
53825|NCT01277302|Secondary|Percentage of Participants With Intraretinal Edema|The presence of intraretinal edema was defined as the presence of subretinal fluid, cystoid spaces, or central retinal thickness ≥ 300 µm as evaluated in spectral-domain optical coherence tomography images by the Digital Angiography Reading Center, the central reading center. At baseline, all participants in the Monthly and PRN groups had presence of edema.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
53826|NCT01277302|Secondary|Mean Change From Baseline in Central Foveal Thickness|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||µm||Standard Deviation|Mean
53827|NCT01277302|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
53978|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||cells/mcL||Standard Deviation|Mean
53828|NCT01277302|Secondary|Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
53829|NCT01277302|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Letters||Standard Deviation|Mean
53830|NCT01277302|Secondary|Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better|VA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
53831|NCT01277302|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.||Percentage of participants||95% Confidence Interval|Number
53832|NCT01277302|Secondary|Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. This outcome measure is not relevant for subjects in the non-randomized group because they never met the VA-OCT stability criteria.|Month 7 through Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.||Letters||Standard Deviation|Mean
53833|NCT01277302|Primary|Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.|Baseline to Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the Monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.||Letters||Standard Deviation|Mean
53834|NCT01277042|Secondary|Number of Subjects With Outcome of Pregnancies|The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, solely on subjects with outcome of pregnancies.||Subjects|||Number
53835|NCT01277042|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)|MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
53836|NCT01277042|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18|A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
53979|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percent||Standard Deviation|Mean
53837|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 – 29) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
53838|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||Subjects|||Number
53839|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination.|During the 7 days (Days 0 – 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
53840|NCT01277042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade.|During the 7 days (Days 0 – 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||Subjects|||Number
53841|NCT01277042|Secondary|Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies|Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
53842|NCT01277042|Secondary|Number of Subjects Seropositive Against HPV-16 and HPV-18|A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
53843|NCT01276847|Secondary|Change From Baseline in Gene Expression Score for Interleukin 17 (IL-17) in Psoriatic Lesions of Participants Treated With Etanercept|Participants had skin biopsies performed at baseline and after treatment with etanercept for 1,2,4 and 16 weeks. The expression of IL-17 mRNA was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Etanercept.||Gene expression score||90% Confidence Interval|Median
53844|NCT01276847|Secondary|Change From Baseline in Composite Gene Expression Score Based on Interleukin 23 (IL-23) Pathway Related Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The mRNA expression of eight pre-defined IL-23 pathway related genes, namely beta 4 defensin (DEFB4), CXC motif chemokine 8 (CXCL8), Interleukins 17A, 17F, 20, 22, 23A (IL-17, IL-17F, IL-20, IL-22, IL-23A) and cyclic AMP dependent protein kinase (CAMP) was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a reduction from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.||Gene expression score||90% Confidence Interval|Median
53865|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||mm||Standard Deviation|Mean
58182|NCT01227993|Secondary|Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
53845|NCT01276847|Primary|Change From Baseline in Composite Gene Expression Score Based on IL-12 Pathway Related Interferon Gamma (IFN-γ)-Modulated Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The expression of messenger RNA (mRNA) from three pre-defined IL-12 pathway related genes, modulated by interferon gamma (IFN-γ), namely IFN-γ, inducible nitric oxide synthase(iNOS) and CXC motif chemokine 10(CXCL10) was quantitated by real-time polymerase chain reaction (qPCR), with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a decrease from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.||Gene expression score||90% Confidence Interval|Median
53846|NCT01276821|Other Pre-specified|Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.|The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results.|2 hours|||Minutes||Standard Deviation|Mean
53847|NCT01276821|Secondary|Persistence of Cough at the End of 1 Week|Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.|7 days|||participants|||Number
53848|NCT01276821|Secondary|Missed Days of Work of Caregivers|Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call.|7 days|||participants|||Number
53849|NCT01276821|Secondary|Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week||7 days|||participants|||Number
53850|NCT01276821|Secondary|Relapse Rate|To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit|24 hours|||Participants|||Number
53851|NCT01276821|Secondary|Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation||At the end of 2 hours|||participants|||Number
53852|NCT01276821|Primary|Mean Change in Clinical Severity Score|"Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.~Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.~The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.~The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).~This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale."|2 hours|||units on a scale||Standard Deviation|Mean
53853|NCT01276756|Secondary|Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)|The occurence of adverse events that could be linked temporally and reasonably to the administration of the tested drug.|throughout the period of treatment and up to 90 days after end of triple therapy|||participants|||Number
53854|NCT01276756|Secondary|End-of-treatment Response|An end-of-treatment response is defined as a negative HCV PCR at 48 weeks after the start of pegylated interferon and ribavirin|48 weeks +- 7 days after starting pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.||participants|||Number
53855|NCT01276756|Secondary|Early Virological Response|"A complete early virologic response is defined as a negative HCV PCR 90 days after the start of pegylated interferon.~A partial early virologic response is defined as a decrease of 2 or more log in HCV PCR at 90 days after the start of pegylated interferon"|90 ± 7 days from the start of pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.||participants|||Number
53856|NCT01276756|Secondary|Rapid Virological Response|A rapid virologic response is defined as a negative HCV PCR 4 weeks after treatment|28 - 33 days after start of Pegylated interferon and ribavirin|"Only 1 patient in standard of care arm and 3 patients in the triple therapy arm missed doing the PCR test at week 4. These patients were thus not included in this particular analysis."||participants|||Number
53857|NCT01276756|Primary|Sustained Virologic Response|sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)|180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).|All was intention-to-treat (ITT) analysis. Any patient who received at least one dose of interferon was included in the analyses.The only 2 dropouts (lost to follow-up) were calculated as failures.||participants|||Number
53858|NCT01276639|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life.|Baseline, Week 16, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
54049|NCT01274559|Secondary|Percent Change From Baseline in LDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53859|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means “ability to work was not affected by psoriasis”, and 10 means “ability to work was completely affected by psoriasis”. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53860|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||percentage of scheduled hours||Standard Deviation|Mean
53861|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for specified parameter for each arm, respectively.||hours||Standard Deviation|Mean
53862|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.||percentage of participants|||Number
53863|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants unemployed (UEmp) at the time of assessment answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||participants|||Number
53864|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||events|||Number
61760|NCT01191242|Primary|(R)-Meth Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
53866|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53867|NCT01276639|Secondary|Joint Pain Assessment (JPA) Score|The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to “select the number that best describes any joint pain that participant may have experienced over the past 24 hours” with response options ranging from “0-no joint pain” to “10-worst possible joint pain.”|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53868|NCT01276639|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants|||Number
53869|NCT01276639|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants|||Number
53870|NCT01276639|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53871|NCT01276639|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53872|NCT01276639|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53873|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
53874|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53875|NCT01276639|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
53876|NCT01276639|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53877|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
53878|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
53879|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
53880|NCT01276639|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||nails||Standard Deviation|Mean
53881|NCT01276639|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
54050|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53882|NCT01276639|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53883|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
53884|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
53885|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
53886|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
53887|NCT01276639|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of BSA||Standard Deviation|Mean
54051|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
61761|NCT01191242|Primary|(R)-Meth Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
53888|NCT01276639|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
53889|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of body surface area (BSA)” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53890|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of BSA” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53891|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
53892|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||units on a scale||Standard Deviation|Mean
53893|NCT01276639|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
53906|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
53894|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.||percentage of participants|||Number
53895|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
53896|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
53897|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
53898|NCT01276639|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||weeks||95% Confidence Interval|Median
53904|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
54052|NCT01274559|Secondary|Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53899|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
53900|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
53901|NCT01276639|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.||percent probability of response||95% Confidence Interval|Number
53902|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.||percent change||Standard Error|Least Squares Mean
53903|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline.|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
53905|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Week 4, 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
53907|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
53908|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
53909|NCT01276639|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
53910|NCT01276639|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS) included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values.||percentage of participants|||Number
53911|NCT01276535|Secondary|Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks|The number of open comedones and closed comedones are summed to attain the total non-inflammatory lesion count.|Baseline and 6 weeks|||lesions||Standard Deviation|Mean
53912|NCT01276535|Secondary|Change From Baseline in Inflammatory Lesion Count at 6 Weeks|The number of pustules, papules and nodules are summed to attain a total inflammatory lesion count.|Baseline and 6 weeks|||lesions||Standard Deviation|Mean
53913|NCT01276535|Primary|Grade on the Burton et al. Acne Severity Grade Scale|The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.|baseline and 6 weeks|||participants|||Number
53914|NCT01276457|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.||Partcipants|||Number
53915|NCT01276457|Secondary|Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft|A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.||Participants|||Number
53916|NCT01276457|Primary|Renal Function Assessed by Creatinine Clearance|Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.|Month 12, Month 18, and Month 24|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.||mL/min||Standard Deviation|Mean
53931|NCT01276301|Other Pre-specified|Verapamil Plasma Concentration|"Verapamil plasma concentration were measured in order to confirm exposure.~Note: No descriptive statistics was calculated for predose, 49.0 (h) and 73.0 (h), as most of the values were below the limit of quantification (BLQ)."|Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration|Treated set (TS) included all subjects who had taken at least one dose of trial medication.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
53917|NCT01276457|Primary|Number of Participants With Biopsy-proven Acute Rejection|A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.||Participants|||Number
53918|NCT01276353|Primary|Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3||Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set: the group of subjects who had received at least one quantifiable E2020 concentration in plasma||ng/mL||Standard Deviation|Mean
53919|NCT01276353|Secondary|Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status|All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i|Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
53920|NCT01276327|Secondary|Tmax for Pioglitazone|Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||hours||Full Range|Median
53921|NCT01276327|Secondary|Tmax for Linagliptin|Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||hours||Full Range|Median
53922|NCT01276327|Secondary|AUC0-∞ of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
53923|NCT01276327|Secondary|AUC0-∞ of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
53924|NCT01276327|Secondary|AUC0-tz for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
53925|NCT01276327|Primary|Cmax of Pioglitazone|Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
53926|NCT01276327|Primary|AUC0-tz of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
53927|NCT01276327|Primary|Cmax of Linagliptin|Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
53928|NCT01276327|Primary|AUC0-72 of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
53929|NCT01276301|Secondary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.|Within Day 15 to Day 25|Treated set||percentage of participants|||Number
53930|NCT01276301|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).|Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events.|Day1 to Day 11|Treated set (TS) included all subjects who had taken at least one dose of trial medication.||participants|||Number
54053|NCT01274559|Secondary|Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
61762|NCT01191242|Primary|(S)- Meth Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
53932|NCT01276301|Secondary|Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)|"Apparent volume of distribution during the terminal phase following an extravascular dose.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation||L||Geometric Coefficient of Variation|Geometric Mean
53933|NCT01276301|Secondary|Apparent Clearance in Plasma After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in plasma after extravascular administration.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
53934|NCT01276301|Secondary|Mean Residence Time in the Body After Administration (MRTpo)|"Mean residence time of empagliflozin (empa) in the body after oral administration.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
53935|NCT01276301|Secondary|Terminal Half-life in Plasma (t1/2)|"Terminal half-life of empagliflozin in plasma.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
53936|NCT01276301|Secondary|Terminal Elimination Rate Constant (λz)|"Terminal elimination rate constant in plasma.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
53937|NCT01276301|Secondary|Time From 0 to Maximum Plasma Concentration (Tmax)|Time from last dosing to the maximum plasma concentration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
53938|NCT01276301|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
53939|NCT01276301|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of empagliflozin (empa) in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol||Geometric Coefficient of Variation|Geometric Mean
53940|NCT01276301|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
53941|NCT01276288|Secondary|Number of Subjects With Clinical Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests, 12-lead Resting Electrocardiogram (ECG), Physical Examination and Assessment of Tolerability by the Investigator|"Number of subjects with clinical relevant abnormalities in vital signs (blood pressure, pulse rate), 12-lead resting electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis, and monitoring of fasting plasma glucose), physical examination and assessment of tolerability by the investigator.~New abnormal findings were reported as Adverse Events (AE). Only Alanine aminotransferase normal under system organ class investigations was determined as an existing AE."|From first drug administration until up to 14 days after the last drug administration, up to 35 days|Treated set||participants|||Number
53942|NCT01276288|Primary|Urinary Sodium Excretion Over 24-hour run-in Periods|Urinary sodium excretion over 24-hour run-in periods to assess the harmonisation of electrolytes after intake of a standardised diet|Day 3, 2 and 1 before the first drug administration|PD analysis set completers||mmol/day||Standard Error|Mean
53943|NCT01276288|Secondary|Maximum Measured Concentration of TOR in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
61187|NCT01195090|Secondary|Baseline Total Cholesterol|Baseline Total cholesterol|Baseline|Baseline Total cholesterol||mg/dl||Standard Deviation|Mean
53944|NCT01276288|Secondary|Area Under the Concentration-time Curve of TOR in Plasma (AUCτ,ss)|Area under the concentration-time curve of TOR in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
53945|NCT01276288|Secondary|Maximum Measured Concentration of HCT in Plasma (Cmax, ss)|Maximum measured concentration of HCT in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
53946|NCT01276288|Secondary|Area Under the Concentration-time Curve of HCT in Plasma (AUCτ,ss)|Area under the concentration-time curve of HCT in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
53947|NCT01276288|Secondary|Maximum Measured Concentration of Empa in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|PK set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
53948|NCT01276288|Secondary|Area Under the Concentration-time Curve of Empa in Plasma (AUCτ,ss)|Area under the concentration-time curve of Empa in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|Pharmacokinetic (PK) set, including all patients of the treated set who provide at least one observation for at least one secondary PK endpoint of AUC τ,ss or C max,ss for any analyte under any treatment without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
53949|NCT01276288|Primary|The Change in Total Muscle Sympathetic Nerve Activity (MSNA) From Off- Treatment|The change in total Muscle sympathetic nerve activity (MSNA) that represents an area under the curve of all C-fiber action potentials per minute. This endpoint was evaluated only for Empa. For this endpoint a baseline value was not defined. However, the parameters obtained at 2 measurements time points during the trial were compared.|One day before the drug administration, then day 4 after the first drug administration|PD analysis set completers||action potentials per min||Standard Error|Mean
53950|NCT01276288|Primary|The Change in Micturition Frequency From the Baseline|For this endpoint the change in total micturition frequency from the baseline was only examined for EMPA where baseline was defined as the day before the first drug administration.|Baseline and day 5|PD analysis set completers||voids per day||Standard Error|Mean
53951|NCT01276288|Primary|Change in Urinary Weight From Baseline|"Change from baseline in urinary weight in a 24 hour (h)- collection period, where baseline is the last 24-h collection period before first trial drug administration in each treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||g/day||Standard Error|Mean
53952|NCT01276288|Primary|Change in Body Weight From Baseline|"Change in body weight from baseline , where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||kg||Standard Error|Mean
53953|NCT01276288|Primary|Change in pH in Capillary or Arterialised Blood From Baseline|"Change in pH in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||pH||Standard Error|Mean
53954|NCT01276288|Primary|Changes in Bicarbonate Concentrations of Calcium, Bicarbonate Ions and Base Excess in Capillary or Arterialised Blood From Baseline|"Changes in bicarbonate concentrations of calcium, bicarbonate ions and base excess in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/ L||Standard Error|Mean
53955|NCT01276288|Primary|Change in Urine Osmolality From Baseline|"Change in urine osmolality from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mOsm/kg||Standard Error|Mean
53956|NCT01276288|Primary|Change in Urine pH From Baseline|"Change in urine pH from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||pH||Standard Error|Mean
53957|NCT01276288|Primary|Change in Urea Concentration in Urine|"Change in urea concentration in urine from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/L||Standard Error|Mean
53958|NCT01276288|Primary|Change in Serum Concentration of Fibroblast Growth Factor-23 (FGF- 23) From Baseline|"Change in serum concentration of fibroblast growth factor-23 (FGF- 23) from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline, The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||RU/mL||Standard Error|Mean
53959|NCT01276288|Primary|Change in Serum Concentration of Aldosterone From Baseline|"Change in serum concentration of Aldosterone from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||nmol/L||Standard Error|Mean
53960|NCT01276288|Primary|Change in Serum Concentration of Renin, Intact Parathyroid Hormone (iPTH) and 1,25-dihydroxyvitamin D From Baseline|"Change in serum concentration of Renin, intact parathyroid hormone (iPTH) and 1,25-dihydroxyvitamin D from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||pg/mL||Standard Error|Mean
53961|NCT01276288|Primary|Change in Serum Concentration of Alkaline Phosphatase (ALP) From Baseline|"Change in serum concentration of ALP from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||U/L||Standard Error|Mean
53962|NCT01276288|Primary|Change in Serum Concentration of Creatinine and Uric Acid From Baseline|"Change in serum concentration of Creatinine and Uric acid from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||umol/L||Standard Error|Mean
53963|NCT01276288|Primary|Change in Serum Concentration of Sodium, Potassium, Magnesium, Calcium, Chloride, Phosphate, Glucose and Urea From Baseline|"Change in serum concentration of sodium, potassium, magnesium, calcium, chloride, phosphate, glucose and urea from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/L||Standard Error|Mean
53964|NCT01276288|Primary|Change in Serum Osmolality From Baseline|"Changes in serum osmolality from baseline based on a blood sample.~Baseline was defined as the measurement obtained before the first drug administration in the first period.~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers||mOsm/Kg||Standard Error|Mean
53975|NCT01275625|Secondary|Number of Participants With Genotypic Resistance.|The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.||Participants|||Number
53965|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of N-terminal Telopeptide (NTx) From Baseline|"Change in urinary excretion in a 24-hour period of N-terminal telopeptide (NTx) from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||nM BCE/ mMC||Standard Error|Mean
53966|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of Sodium, Potassium, Magnesium, Chloride, Calcium, Phosphate, Creatinine, Uric Acid, Glucose From Baseline|"Change in urinary excretion in a 24-hour period of sodium, potassium, magnesium, chloride, calcium, phosphate, creatinine, uric acid, glucose from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period. This applies also to sodium excretion in urine, which is additionally obtained one day before the drug administration before the second period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers||mmol/day||Standard Error|Mean
53967|NCT01276288|Primary|Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline|"Change in clearance of sodium, potassium, creatinine, magnesium, chloride,calcium, phosphate and uric acid from baseline, where baseline is defined as the value obtained from the last 24-h collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|Pharmacodynamic (PD) analysis set completers includes all evaluable patients of the treated set who provide a baseline and at least one on-treatment observation for at least one primary (PD) endpoint under any treatment without important protocol violations relevant to the evaluation of PD and who continued the trial as planned||ml/min||Standard Error|Mean
53968|NCT01276223|Primary|Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks|A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).|Baseline, up to 4 weeks|All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.||units on a scale||Standard Deviation|Mean
53969|NCT01276197|Primary|Diastolic BP Measurement at Follow-up|Participants BP measurement at 6-month follow-up|6-month following intervention|||mmHg||Standard Deviation|Mean
53970|NCT01276197|Primary|Systolic BP at Follow-up|Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.|6 months after intervention|Our analyses was completed with those who completed follow-up visit and varies from participant flow as we are not able to include those lost to follow-up.||mmHg||Standard Deviation|Mean
53971|NCT01276106|Primary|Change in HbA1c From Baseline|For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p<0.05.|24 weeks|The Full Analysis Set included all randomized patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline HbA1c assessment.||percentage points||Standard Error|Least Squares Mean
53972|NCT01276054|Primary|Whether or Not a Patient Has Developed Grade 1+ LE|LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.|During the first year post-operatively|Unable to analyze due to early termination of the study|||||
53973|NCT01275755|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Treatment Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.||Number of SBMs/week||Standard Error|Mean
53974|NCT01275625|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.|Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.||Participants|||Number
53976|NCT01275625|Secondary|Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Ratio||Standard Deviation|Mean
53980|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||cells/microliter (cells/mcL)||Standard Deviation|Mean
53981|NCT01275625|Secondary|Virologic Response: Rate of Virologic Failure at Week 48.|Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.|48 weeks|FAS Population included those participants who had taken at least 1 dose of the study drug.||Participants|||Number
53982|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.|Participants’ responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percentage of participants|||Number
53983|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.|Participants’ responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.||Percentage of participants|||Number
53984|NCT01275625|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.|Participants’ responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|48 weeks|Full Analysis Set (FAS) Population included those participants who had taken at least 1 dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
53985|NCT01275430|Secondary|Phase I: Amount of PICC Tip Movement When the Subject’s Arm is Adducted From a 90° Position to the Subject’s Side.|"Mean distance (mm) of PICC tip movement when the subject’s arm is adducted from a 90° position to the subject’s side, by directly measuring the distance from the catheter tips to the parts of the CAJ (upper, middle, and lower) with the subject's arm at 90°and compared to the PICC tip with the subject's arm at the side .~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||mm||Standard Deviation|Mean
53986|NCT01275430|Secondary|Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject’s Side.|"Measurements (mm) of the location of the cavoatrial junction on Angiographic CT to evaluate shift greater than 5mm in mediastinal structures between ACT acquisitions obtained with the arms above the head vs arms at side of body (90°).~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||mm||Standard Deviation|Mean
53987|NCT01275430|Secondary|Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement|"Proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed.~Note – this endpoint is to assess the diagnostic capability of Angiographic Computed Tomography (ACT). It is not designed to reflect on PICC tip location.~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||participants|||Number
53988|NCT01275430|Secondary|Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary.|"Distance (mm), if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in order to have the PICC tip at the upper cavoatrial junction. Direct measurement of distance from the catheter tips to the parts of the CAJ~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0|||mm||Standard Deviation|Mean
53989|NCT01275430|Primary|Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.|"Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG.~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Time of PICC placement (Day 0)|||mm||Standard Deviation|Mean
53990|NCT01275196|Secondary|Summary Statistics of Trough Imatinib and Major Metabolite CGP74588 of Imatinib and Nilotinib PK Concentration by Time Point|Pharmacokinetic Analysis Set|12 Months|Pharmacokinetic Analysis Set||ng/mL||Standard Deviation|Mean
53991|NCT01275196|Secondary|Actual Dose Intensity|Total dose/time on treatment (periods of zero dose were included).|End of Study (up to 40 months)|Safety set consisted of all randomized patients who received at least one dose of study medication.||mg/day||Standard Deviation|Mean
53992|NCT01275196|Secondary|Modified ELN2009 Criteria|Patients satisfying criteria for several “modified ELN 2009” categories are presented once under the worst category (Optimal> Suboptimal > Treatment failure). Patients in the “Discontinued” category are those who discontinued before the time point considered without satisfying any of the ELN 2009 criteria. Patients in the “Missing” category are those ongoing in the trial at the time point considered but with only missing or non evaluable data for ELN 2009 criteria.|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants|||Number
54054|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
53993|NCT01275196|Secondary|Best Complete Hematologic Response (CHR)|CHR was defined as having all of the following criteria present at any assessment, which was confirmed by another assessment at least after 4 weeks: • WBC count < 10 x 10E9 /L • Platelet count < 450 x 10E9 /L • Basophils < 5% • No blasts and promyelocytes in peripheral blood • Myelocytes + metamyelocytes < 5 % in peripheral blood • No evidence of extramedullary involvement. The assessment was not considered CHR, if there were any values indicative of CML in AP or BC (i.e. by blasts in bone marrow). For confirmation of CHR, both the initial CHR as well as the confirming assessment (at least 4 weeks after the initial assessment) had to satisfy all criteria mentioned above, without any assessment in between which indicated ‘No response’.|Months 1, 3, 4, 5, 6, 9,12, 15,18, 21, 24, 30, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of participants||95% Confidence Interval|Number
53994|NCT01275196|Secondary|Kaplan-Meier Estimates of Overall Survival (OS) on Treatment|Patients who discontinued study treatment early or completed the study protocol and did not enter into the extension protocol were to be followed for survival every 3 months for up to 2 calendar years from the date the last patient randomized received the first dose of study drug and every 6 months until Last Patient Last Visit. Overall survival (all deaths) was defined as the time between date of randomization and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment, i.e. overall survival on-study. The time was censored at the date of last assessment in the study for patients who are still being treated and at the date of last contact for patients who discontinued treatment.|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
53995|NCT01275196|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS) on Treatment|"Progression-free survival was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of death from any cause, whichever is earlier. This variable was analyzed in 2 ways:~On-treatment: included progressions to AP/BC or deaths occurring only on-treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease or cytogenetic evaluation) in the study before the cut-off date of the analysis for patients without event.~On-study: included progressions to AP/BC or deaths occurring in the study or during the follow-up period after discontinuation of study treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment."|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
53996|NCT01275196|Secondary|Kaplan-Meier Estimates of Event-free Survival (EFS) on Treatment|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following:-Death due to any cause, - Progression to AP or BC, Loss of partial cytogenetic response (PCyR), - Loss of CCyR, - Loss of CHR|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
53997|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to Progression to Accelerated Phase/Blast Crisis (AP/BC) on Treatment|"Time to progression to AP/BC was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of CML-related death, whichever is earlier. This variable was analyzed in 2 ways:~On-treatment: included progressions to AP/BC or CML-related deaths occurring on treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease, or cytogenetic evaluation) in the study for patients without event.~On-study: included progressions to AP/BC or CML-related deaths occurring in the study or during the follow-up period after discontinuation of treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment"|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization||Months||95% Confidence Interval|Median
53998|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First CCyR Among Patients Who Achieved CCyR|Duration of CCyR (months) = (date of CCyR loss or censoring-date of first CCyR + 1)/30.4375|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization||Months||95% Confidence Interval|Median
53999|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First CCYR|Time to first CCyR (months) = (date of first CCyR – date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||months||95% Confidence Interval|Median
54000|NCT01275196|Secondary|Best Complete Cytogenic Response (CCyR) Rate by Each Time Point|CCyR is defined as 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.|Months 6, 12, 18, 30, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
54001|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First MMR Among Patients Who Achieved MMR|Duration of first MMR (months) = (date of loss of MMR or censoring-date of first MMR + 1)/30.4375.|End of Study (Up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Months||95% Confidence Interval|Median
54055|NCT01274559|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54002|NCT01275196|Secondary|Durable MMR Rate at 24 Months|The rate of durable MMR at 24 months, defined as the proportion of patients who have achieved MMR at 12 months, and also maintain continuous MMR until the 24 month time point (1 month = 28 days) without intervening loss of MMR in between 12 and 24 months|24 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Perentage of Participants||95% Confidence Interval|Number
54003|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First MMR|Time to first MMR (months) = (date of first MMR or censoring – date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||months||95% Confidence Interval|Median
54004|NCT01275196|Secondary|Best MMR by Each Timepoint|Best MMR rates by scheduled time point are cumulative response rates up to that time point. In this analysis, patients who had achieved MMR at or before the time point were counted as responders, no matter if they lost the response/discontinued or not. Therefore, this response rate represented the best observed response rate up to that specific time point.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
54005|NCT01275196|Secondary|MMR Rate at Each Time Point|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as ‘responders’ and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as ‘non-responders’. These time points including the 12 month data were calculated based on the final analysis after the end of the study.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
54006|NCT01275196|Primary|Major Molecular Response (MMR) at 12 Months - With Imputation.|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as ‘responders’ and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as ‘non-responders’. This endpoint was calculated based on the 12 month analysis.|12 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.||Percentage of Participants||95% Confidence Interval|Number
54007|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 3. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.||ratio||Standard Deviation|Mean
54008|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 1. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.||Ratio||Standard Deviation|Mean
54009|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) for Stage 3 studies is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.||Picomoles*minutes/liter||Standard Deviation|Mean
54010|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1|Area under the glucose concentration curve for 0 to 360 minutes (AUC[0-360]) from Stage 1 is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.||Picomoles*minutes/liter||Standard Deviation|Mean
54011|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 3|Time to 50% of total glucose infused (50%Gtot) is presented for Stage 3. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.||Minutes||Standard Deviation|Mean
54012|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 1|Time to 50% total glucose infused (50%Gtot) is presented for Stage 1. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.||Minutes||Standard Deviation|Mean
54013|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3|Early and late time to 50% maximum glucose infusion rates (tGIR50%max) for Stage 3 studies are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable early and late tGIR50%max data.||Minutes||Standard Deviation|Mean
54014|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1|Early and late times to 50% maximum glucose infusion rate (tGIR50%max) for Stage 1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable early or late tGIR50%max data.||Minutes||Standard Deviation|Mean
54015|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 3 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.||Minutes||Standard Deviation|Mean
54016|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 1 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.||Minutes||Standard Deviation|Mean
54017|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 3|Maximum glucose infusion rates (GIRmax) for Stage 3 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable GIRmax data.||Milligrams/kilogram/minute||Standard Deviation|Mean
54018|NCT01275131|Primary|Early Exposure to Insulin (%AUC[0-60]), Stage 3|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable %AUC(0-60) data.||Percentage of AUC(0-360)||Standard Deviation|Mean
54019|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 1|Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable GIRmax data.||Milligrams/kilogram/minute||Standard Deviation|Mean
54020|NCT01275131|Primary|Early Insulin Exposure (%AUC[0-60]), Stage 1|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose|Participants who completed all study periods within a given stage with evaluable early insulin exposure (%AUC[0-60]) data.||Percentage of AUC(0-360)||Standard Deviation|Mean
54021|NCT01275092|Secondary|The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table|Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.|1 day|||ratio||Inter-Quartile Range|Median
54022|NCT01275092|Primary|Percentage of Patients With Device Technical Success|Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.|1 day|||percentage of participants||95% Confidence Interval|Number
54023|NCT01275092|Primary|Percentage of Participants With Clinical Procedural Success|Defined as <30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.|48-hrs or hospital discharge, whichever occurs first|||percentage of participants||95% Confidence Interval|Number
54024|NCT01275066|Secondary|Percent Change From Baseline in Urine Keratan Sulfate Normalized for Urine Creatinine||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Nine missing outcomes at Week 24 were imputed using method of multiple imputation.||percent change||Standard Deviation|Mean
54025|NCT01275066|Secondary|Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.||stairs/minute||Standard Deviation|Mean
54026|NCT01275066|Primary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.||meters||Standard Deviation|Mean
54027|NCT01274897|Secondary|Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination||during 7 days of vaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.||Subjects|||Number
54028|NCT01274897|Secondary|Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.||Percentages of subjects||95% Confidence Interval|Number
54029|NCT01274897|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.||Titers||95% Confidence Interval|Geometric Mean
54030|NCT01274897|Primary|Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).~Seroresponse is defined as:~for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.~for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer."|day 29|Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points.||Percentages of subjects||95% Confidence Interval|Number
54031|NCT01274715|Primary|Change in Hemoglobin A1C|Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|baseline, 3 months, and 6 months|||percentage of glycated hemoglobin||Standard Deviation|Mean
54032|NCT01274715|Primary|Change in PHQ-9 (Patient Health Questionnaire-9)Scores|The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|Baseline, 3 months, and 6 months|||scores on a scale||Standard Deviation|Mean
54033|NCT01274611|Primary|Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months|"The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment.~This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes.~Percentage sweat rate was calculated as [(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline]*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate."|baseline and 3 months|||Percentage Change|Participants|Full Range|Mean
54034|NCT01274611|Secondary|The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment|"Change in mean score on the Hyperhidrosis Disease Severity Scale (HDSS) from baseline minus 3 months after treatment.~The HDSS iquestionnaire assigns a point value to the patient’s view:~My sweating is...~never noticeable and never interferes with my daily activities~tolerable but sometimes interferes with my daily activities~barely tolerable and frequently interferes with my daily activities~intolerable and always interferes with my daily activities~Lower point values are considered better and higher point values are considered worse.~A larger change in score between baseline and 3 months is considered a better outcome and a smaller change in score is considered a worse outcome for each treatment. Change scores were calculated (baseline minus 3 months). Positive change scores indicate that scores were better; negative change scores indicate their scores were worse after treatment."|Baseline and 3 months|||Scores on a scale|Participants|Standard Deviation|Mean
54035|NCT01274585|Secondary|Change in Fecal Incontinence Quality of Life (FIQoL) Score||4 weeks||||||
54036|NCT01274585|Secondary|Change in Fecal Incontinence Severity Index (FISI) Score||4 weeks||||||
54037|NCT01274585|Primary|Frequency of Fecal Incontinence|Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.|Diary kept for 14 days following treatment|||number of accidents||Full Range|Mean
54038|NCT01274559|Secondary|Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment|assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines|Baseline and 12 weeks|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54039|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54040|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54041|NCT01274559|Secondary|Percent Change From Baseline in Lp(a) at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54042|NCT01274559|Secondary|Percent Change From Baseline in TC:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54043|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54044|NCT01274559|Secondary|Percent Change From Baseline in Apo B at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54045|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54046|NCT01274559|Secondary|Percent Change From Baseline in TG at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54047|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
54048|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.|||||
61188|NCT01195090|Secondary|Baseline Body Weight|Baseline body weight|Baseline|Baseline body weight||kg||Standard Deviation|Mean
54061|NCT01274533|Secondary|Safety of Lenalidomide Monotherapy||28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.|||||
54062|NCT01274533|Primary|Response Rate (CR + Cru + PR)|Peripheral blood, CT or MRI|28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.|||||
54063|NCT01273896|Primary|Overall Response Rate|To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response|Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle|||participants|||Number
54064|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all the female subjects completed the THI questionnaire.||units on a scale||Standard Deviation|Mean
54065|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all male subjects completed the THI questionnaire.||units on a scale||Standard Deviation|Mean
54066|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the THI questionnaire.||units on a scale||Standard Deviation|Mean
54067|NCT01273883|Primary|Tinnitus Distress Rating|This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the distress rating scale.||units on a scale||Standard Deviation|Mean
54068|NCT01273857|Secondary|Serious Adverse Events|The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.|3 months to 1 year after cell transplantation|||participants|||Number
54069|NCT01273857|Primary|Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells|"Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion.~The primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards."|3 months to 1 year after cell transplantation|||participants|||Number
54070|NCT01273818|Primary|Number of Infections in Each Study Arm|Patients were examined on postoperative 30 days for the presence of surgical site infection.|within the 30 days after surgery|||infections|||Number
54071|NCT01273818|Primary|Rate of Post-operative Infection||within the first 30 days after surgery||||||
54072|NCT01273766|Secondary|Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months||||||
54073|NCT01273766|Secondary|Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months||||||
54074|NCT01273766|Primary|Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)|Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)|Baseline, up to 6 months|||10^9 Neutrophils per Liter||Standard Deviation|Mean
54075|NCT01273623|Secondary|Residual Diameter Stenosis|lumen diameter stenosis change post-atherectomy|Day 0|||percentage change||Standard Deviation|Mean
54076|NCT01273623|Secondary|Adjunctive Therapy Use||Day 0|||percentage of participants|||Number
54077|NCT01273623|Primary|Luminal Area Change|lumen area change as measured by intravascular ultrasound (IVUS)|Day 0|||mm^2||Standard Deviation|Mean
54078|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment.||participants|||Number
54079|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy|Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data||participants|||Number
54120|NCT01272908|Secondary|Change From Baseline in ESR During the Re-Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
54080|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment.||participants|||Number
54081|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy|Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data||participants|||Number
54082|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism|If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.|||||
54083|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance|If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.|||||
54084|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance|If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.|||||
54085|NCT01273597|Secondary|Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6|Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|All participants||participants|||Number
54086|NCT01273597|Primary|Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)|Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|Participants who achieved maintenance dose of Zemplar (paricalcitol injection)||weeks||Standard Deviation|Mean
54087|NCT01273519|Primary|Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12|Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.|Baseline, Month 12|All participants with an assessment.||participants|||Number
54088|NCT01273519|Secondary|Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12|The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||mg/dL||Standard Deviation|Mean
54089|NCT01273519|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12|The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||mm/h||Standard Deviation|Mean
54090|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12|The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54091|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12|"The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being easy and 10 impossible”) is used to answer the questions on the test."|Baseline, Months 3, 6, 9, 12|Participants with AS or PsA and an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54103|NCT01273181|Primary|Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer|Tumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years|||Participants|||Number
54104|NCT01273181|Primary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|2 years|||Participants|||Number
58183|NCT01227993|Secondary|Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
54092|NCT01273519|Secondary|Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12|The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54093|NCT01273519|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12|The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI < 0.5.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54094|NCT01273519|Secondary|Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 [worst] to 100 [best ]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54095|NCT01273519|Primary|Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12|Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.|Baseline, Month 12|All participants with an assessment.||participants|||Number
54096|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.||participants|||Number
54097|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.||participants|||Number
54098|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12|Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question “How intensive was your pain on average in the past 3 months?” on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.|Baseline, Month 12|All participants with an assessment.||participants|||Number
54099|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54100|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12|Participants measured their present pain intensity by specifying their level of pain in response to the question “How intensive is your pain at present?” on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.|Baseline, Month 12|All participants with an assessment at time point.||participants|||Number
54101|NCT01273519|Primary|Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54102|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.||units on a scale||Standard Deviation|Mean
54282|NCT01271803|Primary|Time Taken to Reach Maximum Plasma Concentration (Tmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
54105|NCT01273064|Secondary|Greater Than 2 Log Decline in HCV-RNA at Study Weeks 12, 24 and 48|"Percent of patients experiencing a drop in Hepatitis C virus ribonucleic acid (HCV-RNA, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 12, 24, and 48 weeks of treatment."|Baseline, and Study Weeks 12, 24, and 48|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.||Percent of participants|||Number
54106|NCT01273064|Primary|Sustained Virologic Response|Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.|Baseline and 24 weeks after the end of treatment (Week 72)|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.||Percent of participants|||Number
54107|NCT01273038|Primary|Frequency of Ballooning in the Morfeus and SenSura Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|ITT||percentage of bags|Participants||Number
54108|NCT01272947|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|From randomization to end of day 1|||Hours||Inter-Quartile Range|Median
54109|NCT01272947|Primary|Pain on Movement|"Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= No pain and 100= Extreme pain"|VAS Score at 24 hours|||mm||Standard Deviation|Mean
54110|NCT01272934|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|On day 1|||Hours||Inter-Quartile Range|Median
54111|NCT01272934|Primary|Pain on Movement|"Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|72 hours|||mm||Standard Deviation|Mean
54112|NCT01272921|Primary|Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator–Assisted Needle Positioning Beneath the CIEL|Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator–assisted needle positioning beneath the common investing external layer (CIEL).|3 days|||Hours||95% Confidence Interval|Median
54113|NCT01272921|Secondary|Cumulative Probabilities for Needle Positioning Above and Below CIEL.|The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.|1 Day|||Amplitude (mA)||95% Confidence Interval|Mean
54114|NCT01272908|Secondary|Change From Baseline in FACIT-F Total Score During the Re-Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
54115|NCT01272908|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
54116|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
54117|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
54118|NCT01272908|Secondary|Change From Baseline CRP During the Re-Treatment Period|CRP levels were measured in mg/L and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
54119|NCT01272908|Secondary|Change From Baseline in CRP During the Initial Treatment Period|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
61763|NCT01191242|Primary|(S)- Meth Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
54121|NCT01272908|Secondary|Change From Baseline in ESR During the Initial Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
54122|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Re-Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determines the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if >2 categories were missing.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
54123|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Initial Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determined the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if > 2 categories were missing.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
54124|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
54125|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
54126|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
54127|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
54128|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
54129|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm visual analog scale (VAS) where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
54130|NCT01272908|Secondary|Change From Baseline in TJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
54131|NCT01272908|Secondary|Change From Baseline in TJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specific parameter at a given visit.||tender joints||Standard Deviation|Mean
54283|NCT01271803|Primary|Cmax of Cobimetinib on Day 1, Cycle 1 in Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Mean
54132|NCT01272908|Secondary|Change From Baseline in SJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given vist.||swollen joints||Standard Deviation|Mean
54133|NCT01272908|Secondary|Change From Baseline in SJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
54134|NCT01272908|Secondary|Change From Baseline in DAS28 During the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
54135|NCT01272908|Secondary|Change From Baseline in DAS28 During the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
54136|NCT01272908|Secondary|Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
54137|NCT01272908|Secondary|Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score less than or equal to [≤]3.2), moderate (DAS28 score greater than [>]3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
54138|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
54139|NCT01272908|Secondary|Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period|ACR20/50/70, defined as ≥20%, 50%, or 70% improvement, respectively, compared to baseline in TJC and SJC, and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; HAQ-DI; and an acute phase reactant (ESR or CRP). If CRP was missing or not done, then ESR was used.|Weeks 12 and 24 of Re-treatment period|ITT Population||percentage of participants|||Number
54140|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
54141|NCT01272908|Secondary|Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period|ACR20/50/70, defined as ≥20 percent (%), 50%, or 70% improvement, respectively, compared to baseline in tender joint count (TJC) and swollen joint count (SJC), and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and an acute phase reactant (erythrocyte sedimentation rate [ESR] or C-Reactive Protein [CRP]). If CRP was missing or not done, then ESR was used.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population||percentage of participants|||Number
54142|NCT01272908|Secondary|Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary|Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Re-treatment period|ITT Population||percentage of participants|||Number
54553|NCT01267201|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||hr||Full Range|Median
54143|NCT01272908|Primary|Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary|Percentage of participants who reported an AE or serious AE (SAE), a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Initial treatment period|ITT Population||percentage of participants|||Number
54144|NCT01272882|Primary|Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients|Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device.|At the start of monitoring once the patient was consented and enrolled.|||Patients successfully monitored with EIT|||Number
54145|NCT01272869|Primary|Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|Intention to treat (ITT)||percentage bags with ballooning|Participants||Number
54146|NCT01272804|Secondary|Change From Baseline in Lactate Level at Day 6 and 14|Baseline value was collected at 0 hour on Day 1 for lactate.|Baseline (Day 1), Day 6 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
54147|NCT01272804|Secondary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
54148|NCT01272804|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
54149|NCT01272804|Secondary|Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
54150|NCT01272804|Secondary|Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
54151|NCT01272804|Secondary|Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15||Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
54152|NCT01272804|Secondary|Change From Baseline in Average Plasma Glucose at Day 1, 6, 14|Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC [0-24]) divided by 24.|-46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||mg/dL||Standard Deviation|Mean
54153|NCT01272804|Secondary|Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||percent change||Standard Deviation|Mean
54154|NCT01272804|Secondary|Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.||percent change||Standard Deviation|Mean
54155|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percent change||Standard Deviation|Mean
54156|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)|Pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter.||percent change||Standard Deviation|Mean
54157|NCT01272804|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax)|Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
54158|NCT01272804|Primary|Observed Accumulation Ratio for AUCtau (Rac)|Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ratio||Geometric Coefficient of Variation|Geometric Mean
54159|NCT01272804|Primary|Apparent Volume of Distribution (Vz/F) on Day 14|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||liter||Geometric Coefficient of Variation|Geometric Mean
54160|NCT01272804|Primary|Apparent Oral Clearance (CL/F) on Day 14|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||liter per hour||Geometric Coefficient of Variation|Geometric Mean
54161|NCT01272804|Primary|Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14|Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.|0 hour (pre-dose) through 24 hours post-dose on Day 14|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of dose||Standard Deviation|Mean
54162|NCT01272804|Primary|Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
54163|NCT01272804|Primary|Plasma Decay Half-Life (t1/2) on Day 14|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||hour||Standard Deviation|Mean
54164|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14|AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
54165|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||hour||Full Range|Median
54166|NCT01272804|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
54167|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1|AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
54168|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.||hour||Full Range|Median
54169|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.||hour||Full Range|Median
54170|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
54171|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)|Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
54172|NCT01272804|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
54173|NCT01272661|Secondary|Breastfeeding Rate at 6 Months Postpartum|Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum|ITT analysis conducted on participants with available data||participants|||Number
54174|NCT01272661|Secondary|Breastfeeding Rate at 3 Months Postpartum|Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum|ITT analysis conducted on participants with available data||participants|||Number
54175|NCT01272661|Secondary|Breastfeeding Rate at One Month Postpartum|Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.|Any and exclusive breastfeeding at one month, between 21-38 days postpartum|ITT analysis conducted on participants with available data||participants|||Number
54176|NCT01272661|Secondary|Breastfeeding Rate|Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.|Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours|ITT analysis was conducted on participants with available data||participants|||Number
54177|NCT01272661|Primary|Program Feasibility - Curriculum Modules|Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11|by 24 months from program start|||modules presented||Inter-Quartile Range|Mean
54178|NCT01272661|Primary|Program Feasibility- Feeding Outcome Collected|Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome|by 24 months|Total number of eligible MomsFirst participants who agreed to data sharing. Outcome shows number w/ any feeding outcome (not lost to follow up, no live birth, case closed by MomsFirst). This is for a 24 month period since all data was de-identified and stripped of dates so unable to specify for 12 month period||participants|||Number
54179|NCT01272635|Secondary|Drug Related Side Effects|Parent-reported gastrointestinal symptoms during treated RTI.|14 days after initiation of therapy|||events|||Number
54180|NCT01272635|Secondary|Urgent Care Visits, ED Visits and Hospitalizations|Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms.|14 days after initiation of therapy|All participants who initiated APRIL therapy||participants|||Number
54181|NCT01272635|Secondary|Absence From School, Daycare, and/or Parental Work||14 days after initiation of therapy|Data were of insufficient quality to be analyzed.|||||
54182|NCT01272635|Secondary|Asthma Related Symptoms Among RTI Progressing to Severe LRTI|Asthma related symptoms as measured by the parent-completed Pre-school Asthma Symptom Diary (PAD). The PAD was completed daily starting on the first day of an illness and continued until the participant was symptom-free for 2 days. It contains questions of frequency of respiratory symptoms, each scored on a scale of 1 through 7, with higher scores representing increasingly frequent symptoms, with daily scores ranging from 0 (asymptomatic) to a maximum of 102. The total PAD score is the sum of the daily individual symptom scores over the duration of the illness, with higher scores representing more frequent symptoms.|14 days after initiation of therapy|Respiratory Tract Infections (RTI) progressing to Severe Lower RTI||PAD score||Standard Deviation|Mean
54244|NCT01272141|Primary|The Safety and Toxicity of the Combination Therapy of Lapatinib and Everolimus Will be Monitored Using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 3.0. The Incidence of Any Grade 3 or 4 Toxicities Will be Analyzed.||Safety assessments will be performed every four weeks while the patient remains on study.|No data were collected due to early termination.|||||
54183|NCT01272635|Primary|OCELOT: Pediatric Respiratory Assessment Measure|The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.|36-72 hours after initiation of OCELOT therapy|Participants who developed severe lower respiratory tract infections and initiate blinded OCELOT therapy.||PRAM score||Standard Deviation|Mean
54184|NCT01272635|Primary|Progression to Clinically Significant Lower Respiratory Tract Symptoms|Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.|14 days after initiation of APRIL therapy|All participants who initiated APRIL therapy||participants|||Number
54185|NCT01272583|Secondary|Symptomatic Hormone Responses to Acute Hypoglycaemia.|The symptomatic responses to hypoglycaemia were assessed using a standard validated symptom questionnaire adapted for experimental hypoglycaemia (McCrimmon et al (2003) Diabet.Med. 20: 507-509). A 7-point Likert scale (1=symptom absent; 7=symptom experienced with great intensity) was used to score presence and intensity of autonomic and neuroglycopenic symptoms of hypoglycaemia. Symptom scores were obtained during the initialisation phase, at occurrence of autonomic reaction and again 30 minutes later. For analyses the scale was considered as a continuous variable.|Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia|||units on a scale||Inter-Quartile Range|Median
54186|NCT01272583|Secondary|Cortisol Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||mU*minutes/L||Inter-Quartile Range|Median
54187|NCT01272583|Secondary|Growth Hormone Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||mU*minutes/L||Inter-Quartile Range|Median
54188|NCT01272583|Secondary|Norepinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||nmol*minutes/L||Inter-Quartile Range|Median
54189|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20 and 40 minutes|||pmol*minutes/L||Inter-Quartile Range|Median
54190|NCT01272583|Secondary|Epinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||nmol*minutes/L||Inter-Quartile Range|Median
54191|NCT01272583|Secondary|Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes|||pmol*minutes/L||Inter-Quartile Range|Median
54192|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia|Change from initialisation phase to 40 minutes after onset of hypoglycaemia|||pmol/L||Inter-Quartile Range|Median
54193|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 12 Months"|"Success defined as a response of Very Much Better or Much Better at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|12 months|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the PGI-I.||percentage of participants|||Number
54194|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the IIQ-7.||percentage of participants|||Number
54195|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the UDI-6.||percentage of participants|||Number
54196|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 12 Months|"Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST).~The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the cough stress test.||percentage of participants|||Number
54197|NCT01272284|Secondary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months|Success defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months.|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the pad weight test.||percentage of participants|||Number
54198|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 6 Months"|"Success defined as a response of Very Much Better or Much Better at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|6 months|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the PGI-I.||percentage of participants|||Number
54199|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 5 subjects either missed the visit or did not complete the Incontinence Impact Questionnaire.||percentage of participants|||Number
54200|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the Urinary Distress Inventory.||percentage of participants|||Number
54201|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months|"Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.~Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced."|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 17 subjects either missed the visit or did not complete the 3-Day Voiding Diary.||percentage of participants|||Number
54202|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 6 Months|"Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%.~The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|6 months|109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the cough stress test.||percentage of participants|||Number
54203|NCT01272284|Primary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months|Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.|6 months (compared to baseline)|Analysis was per protocol. 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the pad weight test.||percentage of participants|||Number
54204|NCT01272232|Secondary|Incidence of Hypoglycaemic Episodes|Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).|Weeks 0-56|Safety analysis set, comprising all randomised subjects who had been exposed to at least one dose of trial product.||Episodes/100 years of patient exposure|||Number
54205|NCT01272232|Secondary|Change From Week 56 to 68 in Waist Circumference||Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||cm||Standard Deviation|Mean
54206|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||cm||Standard Deviation|Mean
54207|NCT01272232|Secondary|Change (%) From Week 56 to 68 in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percent change||Standard Deviation|Mean
54208|NCT01272232|Secondary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percent change||Standard Deviation|Mean
54209|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||cm||Standard Deviation|Mean
54210|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
54211|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below 7%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
54212|NCT01272232|Secondary|Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)|Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage point change of HbA1c||Standard Deviation|Mean
54245|NCT01272141|Primary|Overall Response Rate Will Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Tumor Assessment for All Lesions Must be Performed Every Eight Weeks While on Study by CT Scan.||Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.|No data were collected due to early termination.|||||
54213|NCT01272232|Primary|Proportion of Subjects Losing More Than 10% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
54214|NCT01272232|Primary|Proportion of Subjects Losing at Least 5% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percentage of subjects|||Number
54215|NCT01272232|Primary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.||percent change||Standard Deviation|Mean
54216|NCT01272219|Secondary|Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).|Week 0, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percent change||Standard Deviation|Mean
54217|NCT01272219|Secondary|Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).|Week 56, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percent change||Standard Deviation|Mean
54218|NCT01272219|Secondary|Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||percentage of subjects|||Number
54219|NCT01272219|Secondary|Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||percent change||Standard Deviation|Mean
54220|NCT01272219|Secondary|Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment|Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||percentage of subjects|||Number
54221|NCT01272219|Secondary|Pre-diabetes Status After 56 Weeks of Treatment|Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percentage of subjects|||Number
54222|NCT01272219|Secondary|Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||cm||Standard Deviation|Mean
54281|NCT01271803|Primary|Area Under Concentration Versus Time Curve (AUC) Over a Period of 24 Hours (AUC0-24) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
54223|NCT01272219|Secondary|Change From Baseline in Waist Circumference (cm)|The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||cm||Standard Deviation|Mean
54224|NCT01272219|Primary|Proportion of Subjects With Onset of Type 2 Diabetes|Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.||Subject|||Number
54225|NCT01272219|Primary|Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight|Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At 56 weeks|The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percentage of subjects|||Number
54226|NCT01272219|Primary|Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.|Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.||percentage of subjects|||Number
54227|NCT01272219|Primary|Change From Baseline in Fasting Body Weight|The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).||percent change||Standard Deviation|Mean
54228|NCT01272193|Secondary|Change in Body Weight|Observed change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
54229|NCT01272193|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
54230|NCT01272193|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
54231|NCT01272193|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
54232|NCT01272193|Secondary|Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal|Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal|Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||mmol/L||Standard Deviation|Mean
54233|NCT01272193|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Observed change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
54246|NCT01272076|Primary|Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).|In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.|August 2011|Subjects with dry AMD and Geographic Atrophy. The required sample size was calculated based on previous experience with the device and its variability.||mm^2||Standard Deviation|Mean
54646|NCT01266122|Secondary|Changes in Psychosocial Mediators|We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.|up to 6 months||||||
54234|NCT01272180|Primary|Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.|The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.|One month after the second vaccination (Day 91)|"Analysis was done on the Per Protocol Set - desirability, ie, all subjects who :~correctly received the vaccine at Visit 1 and Visit 2, provided evaluable serum samples pre- (Visit 1) and post-vaccination (Visit 3), provided post-vaccination solicited adverse event data an had no major protocol violation as defined prior to unblinding."||Desirability index|||Number
54235|NCT01272180|Secondary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.|Throughout the study ( Day 1 to Day 241)|Analysis was done on the unsolicited safety set, ie, all subjects in the all exposed set who provided postvaccination unsolicited AE data.||Participants|||Number
54236|NCT01272180|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.|Day 1 through day 7 after any vaccination|Analysis was done on the solicited safety set, ie all subjects in the all exposed set who provided postvaccination solicited AE data from day 1 (6 hours) through day 7. The all exposed set is defined as all subjects in the all enrolled population who actually received a study vaccination.||Participants|||Number
54237|NCT01272180|Secondary|The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|One month after the second vaccination/prevaccination (Day 91/day 1)|Analysis was done on the per-protocol population||Ratio||95% Confidence Interval|Geometric Mean
54238|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.||Titers||95% Confidence Interval|Geometric Mean
54239|NCT01272180|Secondary|Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|"The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.~4-fold increase is defined as follows;~for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase."|One month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.||Percentages of subjects||95% Confidence Interval|Number
54240|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity||Percentages of subjects||95% Confidence Interval|Number
54241|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.||Titers||95% Confidence Interval|Geometric Mean
54242|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.|Day 1 and one month after second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.||Percentages of subjects||95% Confidence Interval|Number
54243|NCT01272180|Primary|Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.|"Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y.~Seroresponse is defined as:~For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8;~For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer.~Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA)."|One month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity, i.e subjects who received correct vaccines in both the visits; provided evaluable serum sample pre and post vaccination with assay results available for at least one serogroup and/or strain and had no major protocol violations.||Percentages of subjects||95% Confidence Interval|Number
54277|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 14, Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
54247|NCT01272011|Secondary|Ventilatory Loading - Phase 3|Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment.|Pre- versus Post-treatment|Data were collected from 3 participants. However, clinical observations revealed results of interest from only 1/3 of the participants. Therefore, data from only this 1 individual were analyzed for presentation as a case study. The data from the other 2 participants were not analyzed.||unitless||Standard Error|Mean
54248|NCT01272011|Primary|Minute Ventilation - Phase 2|Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.|Pre- versus Post-treatment|||percentage of baseline||Standard Error|Mean
54249|NCT01271946|Secondary|Time to Ambulation|Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per Protocol-Diagnostic Cohort.||Hours||Standard Deviation|Mean
54250|NCT01271946|Secondary|Time to Hemostasis|Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.|Hemostasis was evaluated immediately following procedural sheath removal.|Per protocol-Diagnostic Cohort.||Minutes||Standard Deviation|Mean
54251|NCT01271946|Primary|Percentage of Participants With Bed Elevation Within 15 Minutes.|Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.|Post procedure|Per protocol.||Percentage of participants|||Number
54252|NCT01271946|Primary|Time to Ambulation|Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per protocol.||Hours||Standard Deviation|Mean
54253|NCT01271946|Primary|Time to Actual Discharge|The time from sheath removal to actual hospital discharge.|Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.|Per protocol.||Hours||Standard Deviation|Mean
54254|NCT01271946|Primary|Time to Discharge Eligibility|The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.|Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.|Per Protocol.||Hours||Standard Deviation|Mean
54255|NCT01271946|Primary|Time to Hemostasis|The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.|Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.|Per protocol.||Minutes||Standard Deviation|Mean
54256|NCT01271946|Primary|Minor Adverse Events|Observation of any minor access site-related complications.|Procedure through 30 day follow-up.|||Percentage of participants|||Number
54257|NCT01271946|Primary|Device Success|Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.|Procedure|Intent to treat.||Percentage of participants|||Number
54258|NCT01271946|Primary|Major Adverse Events Reported as Percentage of Participants With Adverse Events.|Observation of any major access site-related complication (percentage of participants).|Procedure through 30 day follow-up.|||Percentage of participants|||Number
54259|NCT01271946|Primary|Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.||Procedure through 30 days follow-up.||||||
54260|NCT01271907|Primary|Safety of Drosophila Generated PBL Administered in Combination With a Lymphodepleting Preparative Regimen and Supportive Systemic Aldesleukin|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.||Participants|||Number
54261|NCT01271907|Primary|Clinical Response|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression disease (PD) is at least a 20 % increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.||Participants|||Number
54262|NCT01271803|Secondary|Pharmacodynamics: Number of Participants With Mitogen-Activated Protein Kinase (MAPK) Inhibition, as Assessed by Immunohistochemistry (IHC)|Changes in effector molecules of the MAPK pathway that are directly or indirectly affected by BRAF and MEK inhibition (including but not limited to ERK and phosphorylated ERK and MEK) by IHC using biopsies at baseline, between Days 10−14 of Cycle 1, and at disease progression. IHC is a staining process performed on fresh/frozen tumor tissue samples.|At baseline; Cycle 1: Day 14; at disease progression (Up to 32 months)|Number of participants analyzed=number of participants available for analysis of this outcome measure.||participants|||Number
54278|NCT01271803|Primary|Tmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
54263|NCT01271803|Secondary|Average Percent Change From Baseline in Fluorodeoxyglucose-positron Emission Tomography (FDG-PET) at Cycle 1 and Cycle 2|The pharmacodynamic effect of cobimetinib in combination with vemurafenib was assessed by measuring changes in FDG uptake as characterized by the lean body mass corrected (LBM) maximum standardized uptake value (SUV max) measurement using FDG-PET. Post-baseline timepoint Cycle 1 was averaged between Days 10 to 14 and Cycle 2 for Days 14+7.|Cycle 1 (Days 10 to 14), Cycle 2 (Days 14+7)|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.||Percent change in FDG-PET||Standard Deviation|Mean
54264|NCT01271803|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. OS analyzed using Kaplan-Meier estimate.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.||months||95% Confidence Interval|Median
54265|NCT01271803|Secondary|Median Duration of Response (DOR)|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST v 1.1, or death from any cause during the study (that is within 30 days after the last dose of study treatment).|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) and had an objective response (of CR or PR) was included in the analysis of this outcome.||months||95% Confidence Interval|Median
54266|NCT01271803|Secondary|Percentage of Participants With Disease Progression According to RECIST V 1.1|Progressive disease (PD) according to RECIST V 1.1: at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (nadir), including baseline; in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of 1 or more lesions is also considered as progression.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.||percentage of participants|||Number
54267|NCT01271803|Secondary|Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1|Tumor response of CR or PR is considered as objective response. CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.||percentage of participants||95% Confidence Interval|Number
54268|NCT01271803|Primary|Tmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
54269|NCT01271803|Primary|Cmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
54270|NCT01271803|Primary|Tmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.||hours||Full Range|Median
54271|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in Cohort 1A in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.||mcg/mL||Standard Deviation|Mean
54272|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population.Here, number of participants analyzed = participants who were BRAFi-naïve participants.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
54273|NCT01271803|Primary|Tmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.||hours||Full Range|Median
54274|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 of Cohorts 1C and 2A in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.||mcg/mL||Standard Deviation|Mean
54275|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Days -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
54276|NCT01271803|Primary|Clearance (CL) of Cobimetinib on Day 14 (Steady State), Cycle 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
54284|NCT01271803|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hours [hr]) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population included all participants who received study treatment and had at least one vemurafenib and cobimetinib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
54285|NCT01271803|Primary|Maximum Tolerated Doses (MTD) of Vemurafenib and Cobimetinib When Administered in Combination in DES|The highest dose level(s) at which fewer than one-third of participants experienced a DLT was declared the MTD. DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade ≤1 within 7 days, b) Grade 3 rash/photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cuSCC that was subsequently resected, d) Grade ≥3 fatigue/hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum CPK levels, which is asymptomatic, deemed to be clinically insignificant and returns to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (ANC <500/ μL), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||mg|||Number
54286|NCT01271803|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During DES in Combination Cohorts|DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade less than or equal to (≤) 1 within 7 days, b) Grade 3 rash or photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cutaneous squamous cell carcinoma (cuSCC) that was subsequently resected, d) Grade greater than or equal to (≥) 3 fatigue or hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum creatine phosphokinase (CPK) levels, which is asymptomatic, deemed by the investigator to be clinically insignificant and that returned to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (absolute neutrophil count [ANC] less than <500/microliter [μL]), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population (SEP) included all participants who received at least one dose of study drug. SEP participants who received combination study treatment (cobimetinib + Vemurafenib) were included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
54287|NCT01271712|Secondary|Duration of Response (DOR)|Duration of Response was defined as the time from date of first response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).] or Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set with response participants||Days||95% Confidence Interval|Median
54288|NCT01271712|Secondary|Disease Control Rate (DCR)|Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)||Percentage of Participants||95% Confidence Interval|Number
54289|NCT01271712|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.|Full Analysis Set (FAS)||Percentage of Participants||95% Confidence Interval|Number
54290|NCT01271712|Secondary|Tumor Response|Tumor Response of a subject was defined as the best tumor response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).], Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], Stable Disease [SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], or Progressive Disease [PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)||Percentage of Participants||95% Confidence Interval|Number
54647|NCT01266122|Secondary|Acquisition of STIs - Number of Participants That Acquired STIs|We will test for locally relevant STIs at baseline and 6 months.|6 months|||participants|||Number
54291|NCT01271712|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST [Response Evaluation Criteria in Solid Tumors] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
54292|NCT01271712|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the number of participants with events is presented.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately one year|Full Analysis Set (FAS)||Percentage of participants|||Number
54293|NCT01271712|Primary|Progression-free Survival|Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)|Full Analysis Set (FAS) - defined as all randomized participants.||Days||95% Confidence Interval|Median
54294|NCT01271686|Primary|Nocturnal Intraocular Pressure (IOP) Change|Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.|4 weeks|||mmHg||Standard Deviation|Mean
54295|NCT01271543|Secondary|Time to Complete Laryngoscopy and Successful Intubation||Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.|||seconds||Standard Deviation|Mean
54296|NCT01271543|Primary|Heart Rate and Blood Pressure Double Product|The double product was measured. The double product is calculated by multiplying the heart rate with the systolic blood pressure. It is also known as the rate pressure product and it is used to measure hemodynamic response.The double product is calculated from the values obtained preinduction, during intubation and after intubation.(5 minutes after intubation)The double products from each time point are averaged to get one mean double product value.|Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.|double product (DP) of systolic blood pressure multiplied by heart rate||(beats/minute)*mmHg||Standard Deviation|Mean
54297|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.||Number of Subjects|||Number
54298|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.||Number of Subjects|||Number
54299|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.||Number of Subjects|||Number
54300|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 28 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|ITT: all randomized subjects.||Number of Subjects|||Number
54301|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.||Number of Subjects|||Number
54302|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.||Number of Subjects|||Number
54554|NCT01267201|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
54303|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.||Number of Subjects|||Number
54304|NCT01271452|Primary|Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS)|Number of subjects with a treatment response at Day 28 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|Intent-to-treat (ITT): all randomized subjects.||Number of Subjects|||Number
54305|NCT01271413|Secondary|Digit Symbol Substitution Test||baseline, 7 weeks||||||
54306|NCT01271413|Secondary|Delay Discounting||baseline, 7 weeks||||||
54307|NCT01271413|Secondary|Addiction Severity Index||baseline, 7 weeks||||||
54308|NCT01271413|Secondary|go/No-go||baseline, 7 weeks||||||
54309|NCT01271413|Secondary|Trail-making||baseline, 7 weeks||||||
54310|NCT01271413|Secondary|Episodic Memory||baseline, 7 weeks||||||
54311|NCT01271413|Primary|Working Memory|Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks|baseline, 7 weeks|||digits recalled||Standard Deviation|Mean
54312|NCT01271244|Primary|To Investigate the Effects of Escitalopram on an Absolute or Relative Decrease in Cardiac Sympathetic Function and Serious Cardiac Side Effects as Measured by QT Interval Variability in OEF/OIF Veterans With PTSD.||12 weeks||||||
54313|NCT01271244|Primary|1.To Investigate the Effects of Escitalopram on Cardiac Vagal Function as Measured by R-R Interval Variability, Especially in the HF (0.15-0.5 Hz) Band in OEF/OIF Veterans With PTSD.||12 Weeks|||msec||Standard Deviation|Mean
54314|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
54315|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
54316|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
54317|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set||Participants|||Number
54318|NCT01271036|Primary|Number of Participants With Physical Irritation Scores|Severity of physical irritation scored by the Investigator on a scale from 0 (no irritation) to 6 (presence of lesions). Since a score of 0 is required at baseline for inclusion in the study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity).|One week|Full Analysis Set||Participants|||Number
54319|NCT01270971|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
54320|NCT01270971|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
54321|NCT01270971|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.||participants|||Number
54322|NCT01270971|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.||participants|||Number
55396|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy|End of 4-week intervention|Two SIP subjects had missing data for this variable.||percentage of time in bed spent asleep||95% Confidence Interval|Mean
54323|NCT01270958|Primary|Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion|Nasal polyps are non cancerous growths occurring in the nose or sinuses. Nasal ulcers are a break in skin or mucous membrane with loss of surface tissue, disintegration and necrosis of epithelial tissue.|Baseline and treatment completion (up to Week 6)|ITT Population||percentage of participants|||Number
54324|NCT01270958|Primary|Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion|The electrocardiogram is a recording of the electrical activity of the heart as it undergoes excitation (depolarization) and recovery (polarization) to initiate each beat of the heart. Normal ECG readings show a slight flat-dip in between contractions and relaxations. An abnormal ECG is determined by comparing the results of an ECG graph with a standard or normal heart graph. If these flat-dips are not present, it may be an indication of a more serious problem.|Baseline and treatment completion (up to Week 6)|ITT Population||participants|||Number
54325|NCT01270958|Primary|Albumin Value at Baseline and After Treatment Completion|Albumin is a simple water-soluble protein found in many tissues and liquids. Normal range: 35-50 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population||g/L||Standard Deviation|Mean
54326|NCT01270958|Primary|Total Protein Value at Baseline and After Treatment Completion|A total protein assay measures the amount of proteins found in the plasma. Normal range: 65-82 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population||g/L||Standard Deviation|Mean
54327|NCT01270958|Primary|Urea Nitrogen Value at Baseline and After Treatment Completion|The urea concentration of serum or plasma, conventionally specified in terms of nitrogen content and called blood urea nitrogen (BUN), is an important indicator of renal function. Normal range: 2.5-7.5 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
54328|NCT01270958|Primary|Glucose Value at Baseline and After Treatment Completion|Glucose is a simple sugar used as a source of energy for cellular metabolism. Normal range: 3.9-6.4 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
54329|NCT01270958|Primary|Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion|ALT is a liver enzyme that plays a role in protein metabolism. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs. Normal range: <=40 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population||U/L||Standard Deviation|Mean
54330|NCT01270958|Primary|Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion|AST is a liver enzyme released into the blood when certain organs or tissues, particularly the liver and heart, are injured. Normal range: <=37 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population||U/L||Standard Deviation|Mean
54331|NCT01270958|Primary|Alkaline Phosphatase Value at Baseline and After Treatment Completion|Alkaline phosphatase is an enzyme produced by the liver or bone. An elevated level of alkaline phosphatase in the blood may indicate a liver or bone problem. Normal range: 30-120 units per liter (U/L).|Baseline and treatment completion (up to Week 6)|ITT Population||U/L||Standard Deviation|Mean
54332|NCT01270958|Primary|Creatinine Value at Baseline and After Treatment Completion|Creatinine is a metabolic waste product in urine that remains relatively constant in an individual and that may be used to establish baseline renal function. Normal range: 53-100 umol/L (female) and 62-120 umol/L (male).|Baseline and treatment completion (up to Week 6)|ITT Population||umol/L||Standard Deviation|Mean
54333|NCT01270958|Primary|Total Bilirubin Value at Baseline and After Treatment Completion|Total bilirubin is formed when hemoglobin breaks down. Bilirubin is excreted in bile and urine, and elevated levels may indicate certain diseases. Normal range: <=17 micromoles per liter (umol/L).|Baseline and treatment completion (up to Week 6)|ITT Population||umol/L||Standard Deviation|Mean
54334|NCT01270958|Primary|Potassium Count at Baseline and After Treatment Completion|Potassium is the major positive ion (cation) found inside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 3.5-5.0 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
54335|NCT01270958|Primary|Sodium Count at Baseline and After Treatment Completion|Sodium is the major positive ion (cation) found outside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 135-145 millimoles per liter (mmol/L).|Baseline and treatment completion (up to Week 6)|ITT Population||mmol/L||Standard Deviation|Mean
54336|NCT01270958|Primary|Platelet Count at Baseline and After Treatment Completion|Platelets are cells found in the blood that play a role in blood clotting. Normal range: 150-400 Giga/L.|Baseline and treatment completion (up to Week 6)|ITT Population||Giga/L||Standard Deviation|Mean
54337|NCT01270958|Primary|White Blood Cell Count at Baseline and After Treatment Completion|White blood cells are cells of the immune system that defend the body against both infectious disease and foreign materials. Normal range: 4-10 10^9 cells per liter (Giga/L).|Baseline and treatment completion (up to Week 6)|ITT Population||Giga/L||Standard Deviation|Mean
54338|NCT01270958|Primary|Red Blood Cell Count at Baseline and After Treatment Completion|Red blood cells are cells in the blood that are used to transport oxygen throughout the body. Normal range: 3.9-5.8 10^12 cells per liter (Tetra/L).|Baseline and treatment completion (up to Week 6)|ITT Population||Tetra/L||Standard Deviation|Mean
54339|NCT01270958|Primary|Hematocrit Values at Baseline and After Treatment Completion|Hematocrit is the proportion of blood volume that is occupied by red blood cells. The hematocrit (Hct) is expressed as liter of red blood cells in liters of blood. Normal range: 0.35-0.50 Liter/Liter.|Baseline and treatment completion (up to Week 6)|ITT Population||Liter/Liter||Standard Deviation|Mean
54340|NCT01270958|Primary|Hemoglobin Values at Baseline and After Treatment Completion|Hemoglobin functions primarily to transport oxygen from the lungs to the body tissues. Normal range: 125-160 grams per liter (g/L).|Baseline and treatment completion (up to Week 6)|ITT Population||g/L||Standard Deviation|Mean
54341|NCT01270958|Primary|Heart Rate at Screening/Visit 1, Visit 2, and Visit 3|Heart rate is measured as the number of heart beats per unit time.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population||beats per minute (bpm)||Standard Deviation|Mean
54648|NCT01266122|Primary|Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant|We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.|up to 6 months|||number of unprotected sex acts||Standard Deviation|Mean
54342|NCT01270958|Primary|Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population: Some participants were lost to follow-up and may not have been dosed with study drug.||mmHg||Standard Deviation|Mean
54343|NCT01270958|Primary|Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug. Some participants were lost to follow-up and may not have been dosed with study drug.||millimeters of mercury (mmHg)||Standard Deviation|Mean
54344|NCT01270919|Secondary|To Evaluate the Change in Outcomes From the Preoperative Time Point to Postoperative Time Points in Cases Implanted With the BioDuct® Meniscal Repair Device Using the SF-12, VAS Pain, WOMET and IKDC Subjective Knee Evaluation.||Postoperative compared to preoperative||||||
54345|NCT01270919|Primary|To Demonstrate Repair of the Meniscus 6 Months Post-implantation of the BioDuct® Meniscal Repair Device, Utilizing MRI. To Evaluate Clinical Success Using Postoperative Qualitative Criteria, as Compared to Preoperative Findings.||2 years||||||
54346|NCT01270880|Secondary|Potential Markers for Predicting Drug Response or Efficacy||At baseline, day 1 of course 3, and end of treatment||||||
54347|NCT01270880|Secondary|Association of PFS and PSA Response Rate With Primary and Secondary Target Markers||At 6 months||||||
54348|NCT01270880|Secondary|OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy||From first dose to death or the date last known alive||||||
54349|NCT01270880|Secondary|Overall Safety and Tolerability of STA-9090||Day 1, 8, and 15 of each course and at end of treatment||||||
54350|NCT01270880|Secondary|Percentage Change in PSA||From baseline to 12 weeks||||||
54351|NCT01270880|Primary|PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy|Defined as the time from first dose until the patient demonstrates disease progression based on PSA changes, discontinues STA-9090 therapy (for any reason), or expires (from any cause), whichever occurs first. Estimated with the standard Kaplan-Meier (K-M) method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived.|At 6 months|||months||90% Confidence Interval|Median
54352|NCT01270867|Secondary|Secondary Endpoint|Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure|24 hours|||participants|||Number
54353|NCT01270867|Secondary|Secondary Endpoint|All cause mortality at 90 days|procedure through 90 days|||participants|||Number
54354|NCT01270867|Secondary|Secondary Endpoint|"Good clinical outcomes at 90 days, as assessed by mRS (a good clinical outcome is defined as mRS </= 2)~mRS 0-2 indicates functional independence 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Sca"|90 days|||participants|||Number
54355|NCT01270867|Primary|Primary Safety Endpoint|Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).|within 24 hours of procedure|||participants|||Number
54356|NCT01270867|Primary|Primary Efficacy Endpoint|"Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device.~Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.~Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...~Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|acute/procedural|Intent to treat analysis was performed. The non-inferiority hypothesis was tested with Blackwelder's method, assuming a one-sided alpha=0.025 and a clinically relevant non-inferiority margin of 10%.||participants|||Number
54357|NCT01270841|Secondary|Reproductive Safety|Change from baseline in sperm concentration|3 months|Subjects with end of study assessments||millions/mL||Standard Deviation|Mean
54358|NCT01270841|Secondary|Change in FSH After 3 Months of Treatment||3 months|ITT population||mIU/mL||Standard Deviation|Mean
54359|NCT01270841|Secondary|Change in Luteinizing Hormone Levels|Changes in values from baseline in LH at month 3|3 months|ITT population||mIU/mL||Standard Deviation|Mean
54360|NCT01270841|Primary|Change in Total Morning Testosterone|Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim|3 months|Intent to treat subjects with an assessment after baseline||ng/dL||Standard Deviation|Mean
54361|NCT01270828|Secondary|Percentage of Participants With Suicidal Behaviour/Ideation|Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.|Baseline, Weeks 6, 11, 15, 19 and 20|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
54383|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
54362|NCT01270828|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective severe to those AEs that interfere significantly with participant's usual function."|Baseline to Week 20|"The SB Analysis Set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.~Both SBAS and FAS were included in this analysis."||Participants|||Number
54363|NCT01270828|Secondary|Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)|The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
54364|NCT01270828|Secondary|Change in the Brief Pain Inventory (BPI-sf)|The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
54365|NCT01270828|Secondary|Change in Hospital Anxiety and Depression Scales (HADS)|The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
54366|NCT01270828|Secondary|Change in Mean Daily Sleep Interference Scores|The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
54367|NCT01270828|Secondary|Change in the Short Form 36 Health Survey (SF-36)|The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.||Units on a scale||Standard Error|Least Squares Mean
54368|NCT01270828|Secondary|Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score|The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
54369|NCT01270828|Secondary|The MOS-SS-Optimal Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The percentage of participants with optimal sleep is presented here."|Week 6 and Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
54370|NCT01270828|Secondary|Change in the MOS-SS-Quantity of Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The item Quantity of sleep of MOS-SS is presented here."|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Hours||Standard Error|Least Squares Mean
55406|NCT01259245|Secondary|FEV1% Pred|Pred FEV1 percent predicted normal values;measured using spirometry|6 months post-intervention|Intention to treat||percentage of FEV1 predicted||Standard Deviation|Mean
54371|NCT01270828|Secondary|Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).|The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.||Units on a scale||Standard Error|Least Squares Mean
54372|NCT01270828|Secondary|Change in the Weekly NRS-Pain (1-Week Recall).|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week.|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
54373|NCT01270828|Secondary|Change From Baseline to Endpoint in Weekly Mean Pain Score.|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Units on a scale||Standard Error|Least Squares Mean
54374|NCT01270828|Secondary|Percentage of Participants With 50% Reduction in the Mean Pain Score.|The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
54375|NCT01270828|Secondary|Percentage of Participants With 30% Reduction in the Mean Pain Score.|The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Percentage of participants|||Number
54376|NCT01270828|Secondary|Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results|"A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:~At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score~A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR."|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase||Participants|||Number
54377|NCT01270828|Primary|Number of Participants With Loss of Therapeutic Response.|Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.|13 Weeks|The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.||Participants|||Number
54378|NCT01270802|Secondary|Change in Serum Levels of Vitamin D|Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body|Baseline and 24 weeks|||ng/mL||Standard Deviation|Mean
54379|NCT01270802|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Change in FMD is a measure of change in endothelial function|Baseline and 24 weeks|In the Switch to tenofovir/emtricitabine plus raltegravir arm, two FMD measurements at 24 weeks were removed from the analysis due to poor quality imaging.||% change from baseline||Standard Deviation|Mean
54380|NCT01270711|Primary|Prevalence of Valvular Fibrosis|Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.||percentage of participants|||Number
54381|NCT01270711|Primary|Incidence of Valvular Fibrosis|Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during study period.||percentage of participants|||Number
54382|NCT01270711|Primary|Total Number of Echocardiography Examinations in Cabergoline Users|The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.||echocardiography examinations|||Number
56575|NCT01247428|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method|8 hours|||percentage of participants||95% Confidence Interval|Number
54384|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
54385|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
54386|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
54387|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
54388|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of prescriptions|||Number
54389|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 6|Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson’s disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 6 (Year 2011)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
54390|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 5|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 5 (Year 2010)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
54391|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 4|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 4 (Year 2009)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
54433|NCT01270503|Secondary|Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.||Participants|||Number
54434|NCT01270503|Primary|Safety Overview Within 30 Days in Participants Vaccinated With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.||Participants|||Number
54392|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 3|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 3 (Year 2008)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
54393|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 2|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 2 (Year 2007)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
54394|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 1|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 1 (Year 2006)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of prescriptions|||Number
54395|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 6|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
54396|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 5|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
54397|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 4|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
54398|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 3|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
54399|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 2|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
54400|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 1|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||prescriptions|||Number
54401|NCT01270620|Secondary|Amount of Intraoperative Fentanyl||From the anesthesia induction until extubation|||micrograms||Inter-Quartile Range|Median
54402|NCT01270620|Secondary|Duration of Anesthesia||Time from induction to extubation|||minutes||Inter-Quartile Range|Median
54403|NCT01270620|Secondary|Duration of Surgery||Time from Incision to closure of surgery|||minutes||Inter-Quartile Range|Median
55407|NCT01259245|Secondary|FEV1|Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry|6 months post-intervention|Intention to treat analysis||liters||Standard Deviation|Mean
54404|NCT01270620|Primary|Trail Making Part B|Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
54405|NCT01270620|Primary|Trail Making Part B|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
54406|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
54407|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
54408|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
54409|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
54410|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 48 hours after surgery|||participants|||Number
54411|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 6-8 hours after surgery|||participants|||Number
54412|NCT01270620|Secondary|ProBNP||Change from baseline to post-operative day 2|||ng/L||Inter-Quartile Range|Median
54413|NCT01270620|Secondary|BNP||Change form baseline to post-operative day 2|||ng/L||Inter-Quartile Range|Median
54414|NCT01270620|Secondary|Troponin I|Patients who had troponin level > 0.2 ng/mL|2 days|||participants|||Number
54415|NCT01270620|Secondary|N-terminal proBNP||Change from baseline to day one|||ng/L||Inter-Quartile Range|Median
54416|NCT01270620|Secondary|B-type Natriuretic Peptide||Change from Baseline to day one|||ng/L||Inter-Quartile Range|Median
54417|NCT01270620|Secondary|Recovery Room Time||first day|||minutes||Inter-Quartile Range|Median
54418|NCT01270620|Secondary|Nausea and Vomiting||48 hours|||participants|||Number
54419|NCT01270620|Secondary|- Time to Following Command After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
54420|NCT01270620|Secondary|- Time to Tracheal Extubation After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
54421|NCT01270620|Secondary|- Time to Eye Opening After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
54422|NCT01270620|Secondary|- Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation||first day|||seconds||Inter-Quartile Range|Median
54423|NCT01270620|Primary|Assessment of Delirium|The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).|48 hours|||participants|||Number
54424|NCT01270581|Primary|Duration of Respiratory Support|Data not collected due to insufficient enrollment for any data analysis.|average of 7 days||||||
54425|NCT01270555|Secondary|Beck Depression Inventory (BDI)|minimum score (least severe depression) = 0, maximum score (most severe) = 63|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
54426|NCT01270555|Secondary|Hamilton Depression Scale (HAM-D)|minimum score (least severe depression) = 0, maximum score (most severe) = 84|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
54427|NCT01270555|Secondary|Hamilton Anxiety Scale (HAM-A)|minimum score (least severe anxiety) = 0, maximum (most severe) = 56|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
54428|NCT01270555|Primary|Self-reported Weekly Substance Use|Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.|baseline and six weeks|||Participants|||Number
54429|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of ADHD Severity|Global Severity (CGI-S) 1=not ill, 7=extremely ill|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
54430|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity|CGI-S 1=not ill, 7=extremely ill|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
54431|NCT01270555|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score|Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)|baseline and six weeks|||Units on a scale||Standard Deviation|Mean
54432|NCT01270529|Primary|Change in Physical Activity|Participants will measure physical activity in the form of daily steps using a pedometer|Baseline, 12 weeks|||change in steps per day||95% Confidence Interval|Mean
54435|NCT01270464|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Week 8, Week 16, Endpoint, and Overall|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the two experimental treatment arms. Blood samples were collected for determination of ADAs before study drug infusion at baseline, visit 4 (week 8), and at visit 6 (week 16: EOT or early withdrawal) from patients in all 3 treatment groups (ie, placebo, 0.3 mg/kg reslizumab, and 3.0 mg/kg reslizumab); however, only the blood samples drawn from patients treated with either 0.3 mg/kg reslizumab or 3.0 mg/kg reslizumab were analyzed. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).~Endpoint =week 16 or early withdrawal."|Day 1 (pre-dose), week 8, 16 and endpoint|Pharmacokinetic analysis set. Anti-Reslizumab antibody status was not analyzed for patients in the Placebo treatment arm.||participants|||Number
54436|NCT01270464|Secondary|Shifts From Baseline to Endpoint in Electrocardiogram Findings|Participant counts in each category of shift from baseline to endpoint of ECG finding. Findings summarized as normal or abnormal.|Weeks -4 to -2 (Screening Visit), Week 16|Safety analysis set of participants with both baseline and endpoint values.||participants|||Number
54437|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse - high: >100 and increase of >= 30 beats/minute~Sitting pulse - low: <50 and decrease of >=30 beats/minute~Sitting diastolic blood pressure: >100 and increase of >=12 mmHg~Respiration rate: >24 and increase of >=10 breaths/minute~Body temperature: <96.5° Fahrenheit or <35.8° Celsius~The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set||participants|||Number
54438|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.~Total bilirubin: >=34.2 μmol/L~White blood cells: <=3.0 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 %~Platelets: >=700 10^9/L~Absolute neutrophil count: <=1.0 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline~The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set||participants|||Number
54439|NCT01270464|Secondary|Participants With Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29).|Day 1 (post-dose) to Week 29|Safety analysis set||participants|||Number
54440|NCT01270464|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms. The during treatment (weeks 4, 8, 12 and 16) average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
54441|NCT01270464|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.||SABA puffs per day||Standard Error|Least Squares Mean
54442|NCT01270464|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control. The during treatment (weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
54940|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54443|NCT01270464|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 16 or at Last Observed Value|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were “patient-specific,” which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life. The AQLQ score was only assessed once during the study at week 16 or at early withdrawal, i.e. last postbaseline assessment if within 3 to 5 weeks of the last dose of study drug."|Day 1 (baseline, pre-dose), Week 16 or last observed value|Full analysis set of participants with assessments at stated timeframes.||units on a scale||Standard Error|Least Squares Mean
54444|NCT01270464|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient’s FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including participants who contributed at least once to the analysis.||units on a scale||Standard Error|Least Squares Mean
54445|NCT01270464|Secondary|Change From Baseline in % Predicted Expiratory Volume In 1 Second (FEV1) at Week 16 and at Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Endpoint =week 16 or early withdrawal.|Day 1 (baseline, pre-dose), Week 16, endpoint|Full analysis set of participants with assessments at stated timeframes.||percentage of predicted FEV1||Standard Deviation|Mean
54446|NCT01270464|Secondary|Change From Baseline in Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) Over 16 Weeks Using Mixed Model for Repeated Measures|The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC). The during treatment (weeks 4, 8, 12 and 16) average FEF 25%-75% was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.||liters/second||Standard Error|Least Squares Mean
54447|NCT01270464|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Over 16 Weeks Using Mixed Model for Repeated Measures|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. The during treatment (weeks 4, 8, 12 and 16) average FVC was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
54448|NCT01270464|Primary|Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. The during treatment (weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline scores indicate improvement in asthma control."|Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Full analysis set-all patients randomly assigned to treatment and treated with at least 1 dose of study drug. Number of participants analyzed includes those who contributed at least once to the analysis.||liters||Standard Error|Least Squares Mean
54449|NCT01270256|Primary|Change in Nasal Peak Inspiratory Flow (NPIF)|NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated|Baseline and 26 days|||liters/min||Standard Error|Median
54450|NCT01270139|Secondary|Number of Grain Domains and Membrane Defects on Membrane of Red Blood Cells|Number of grain domains and membrane defects on membrane of red blood cells calculated with atomic force microscopy (AFM). An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively. The results are expected to be released after October 2016.|at 60 months follow-up||10/2016||||
54451|NCT01270139|Secondary|TVR (Target Vessel Revascularization)|TVR (target vessel revascularization) reflects per cent of patients with TVR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively. The results are expected to be released after October 2016.|at 60 months follow-up||10/2016||||
54452|NCT01270139|Secondary|TLR (Target Lesion Revascularization)|TLR (target lesion revascularization) reflects per cent of patients with TLR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively. The results are expected to be released after October 2016.|at 60 months follow-up||10/2016||||
61764|NCT01191242|Primary|Total Meth Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
54453|NCT01270139|Secondary|Cardiac Death|Cardiac death includes per cent of patients passed away due to any cardiac death. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively. The results are expected to be released after October 2016.|at 60 months follow-up||10/2016||||
54454|NCT01270139|Secondary|MACE|MACE includes per cent of patients with cardiac death. STEMI (ST-elevation myocardial infarction), non-STEMI, and TLR (target lesion revascularization). An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively. The results are expected to be released after October 2016.|at 60 months follow-up||10/2016||||
54455|NCT01270139|Secondary|Minimal Lumen Diameter|Minimal lumen diameter (MLD, mm)|at 12-month follow-up|The intention-to-treat analysis||mm||Standard Deviation|Mean
54456|NCT01270139|Secondary|Per Cent of Calcium|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
54457|NCT01270139|Secondary|Per Cent of Necrotic Core|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
54458|NCT01270139|Secondary|Per Cent of Fibrous Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core – red; dense calcium – white; fibrous – green; and fibro-fatty – light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
54459|NCT01270139|Secondary|Target Lesion Revascularization|Target lesion revascularization, per cent|at 12-month follow-up|The intention-to-treat analysis||Percentage of participants|||Number
54460|NCT01270139|Secondary|Per Cent Atheroma Volume|Per cent atheroma volume (PAV, plaque burden, %). Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
54461|NCT01270139|Secondary|Coronary Vasomotion - Mean Lumen Diameter After Infusion of Acetylcholine 10-6 M|Coronary vasomotion was assessed with QCA. End-diastolic images of coronary arteries were evaluated at baseline, after intravascular infusion of acetylcholine (through a microcatheter at increasing doses up to 10-8, 10-7, 10-6 M with a washout period of at least five minutes between each dose), and after nitroglycerine application following acetylcholine (100 µg orally). In all patients, measurements were performed in two segments on site of intervention while 960 seconds. The artery diameter was calibrated against the contrast-filled tip of the catheter. Vasoconstriction to acetylcholine was defined as a 3% change of the mean lumen diameter after infusion of the maximal dose of acetylcholine. An investigator blinded to treatment group performed all measurements.|at 12-month follow-up|The intention-to-treat analysis||mm||Standard Deviation|Mean
54462|NCT01270139|Secondary|Late Definite Thrombosis|Late definite thrombosis rate|at 12-month follow-up|The intention-to-treat analysis||Percentage of participants|||Number
54463|NCT01270139|Secondary|Restenosis Rate|Restenosis (stenosis>50%) rate|at 12-month follow-up|The intention-to-treat analysis||Percentage of patients|||Number
54464|NCT01270139|Secondary|Event Free Survival|The Kaplan-Meier analysis of the cardiac event-free survival (failure-free survival). The end point in this study was cardiac event-free survival during follow-up, starting at randomization. Cardiac events included cardiac death, myocardial infarction and unintended revascularization. Cardiac death was defined as sudden death, death after the onset of symptoms suggestive of cardiac ischemia and death due to heart failure. Noncardiac death was defined as death due to all other causes. Myocardial infarction was defined as an increase in cardiac enzymes or new pathologic Q-waves on the ECG, or both. Unintended revascularization was defined as PTCA or CABG performed due to worsening of the patient’s clinical condition, rather than the PTCA or CABG assigned by the revascularization team when patient management was determined.|at 12-month follow-up|The intention-to-treat analysis||Percentage of survived patients|||Number
54465|NCT01270139|Secondary|Per Cent of Fibro-fatty Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis||Percentage of tissue||Standard Deviation|Mean
55408|NCT01259245|Secondary|FVC|Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry|6 months post intervention|Intention to treat analysis||liters||Standard Deviation|Mean
54466|NCT01270139|Primary|MACE (Major Adverse Cardiovascular Events)-Free Survival|MACE (major adverse cardiovascular events)-free survival reflects per cent of survived patients without MACE. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively. The results are expected to be released after October 2016.|at 60 months follow-up||10/2016||||
54467|NCT01270139|Primary|Total Atheroma Volume|Total atheroma volume (TAV, plaque-media volume, mm3) at 12 months. Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat-population analysis||mm3||Standard Deviation|Mean
54468|NCT01270126|Secondary|Other Visual and EEG Parameters|Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.|Nov 2006 - Dec 2010||||||
54469|NCT01270126|Primary|Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors|Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.|Initial diagnostics (baseline), Post diagnostics|||percent change||Standard Deviation|Mean
54470|NCT01269918|Secondary|Postoperative Shivering|Indicator of whether patients had postoperative shivering.|Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.|||participants|||Number
54471|NCT01269918|Secondary|Postoperative Vomitting|Indicator of whether patients had postoperative vomiting.|Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.|||participants|||Number
54472|NCT01269918|Secondary|Postoperative Nausea|Indicator of whether patients had nausea or not|Whether patients had nausea or not, from anesthesia stop time until hospital discharge.|||participants|||Number
54473|NCT01269918|Secondary|End Case to Post Anesthesia Care Unit (PACU) Discharge|Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.|End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.|||minutes||Inter-Quartile Range|Median
54474|NCT01269918|Secondary|Drug Stop Time to Fitness to Discharge||Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.|||minutes||Inter-Quartile Range|Median
54475|NCT01269918|Secondary|Drug Stop Time to Recall|Time between extubation until patients could say their names.|Time between extubation until patients could say their names.|||minutes||Inter-Quartile Range|Median
54476|NCT01269918|Secondary|Drug Stop Time to Open Eyes|time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery|Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.|||minutes||Inter-Quartile Range|Median
54477|NCT01269918|Secondary|Nursing Workload Comparison|To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).|90 minutes after extubation|||units on a scale||Inter-Quartile Range|Median
54478|NCT01269918|Secondary|Aldrete Score|The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.|||units on a scale||Standard Deviation|Mean
54479|NCT01269918|Secondary|Modified Short Orientation Memory Concentration Test (SOMCT)|The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.|||units on a scale||Standard Deviation|Mean
54480|NCT01269918|Secondary|Heart Rate|Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.|||beats per minute||Standard Deviation|Mean
54481|NCT01269918|Primary|Total Opioid Consumption|Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.|Initial 90 minutes of recover after surgery|||mg morphine equivalents||Inter-Quartile Range|Median
54482|NCT01269918|Primary|Postoperative Pain|Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.|||units on a scale||Standard Deviation|Mean
54483|NCT01269918|Primary|Hemodynamics|Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.|||mmHg||Standard Deviation|Mean
54607|NCT01266876|Secondary|Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline HDL-C value.||mg/dL||Standard Error|Least Squares Mean
61765|NCT01191242|Primary|Total Meth Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
54484|NCT01269801|Primary|Efficacy|"Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include:~-Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved.~Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7.~-Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement."|Week 4, 8, 12, 24|Analysis is based on the randomization group to account for the order in which the products were administered.||participantes rated improved and higher|||Number
54485|NCT01269710|Secondary|Change in LDL (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
54486|NCT01269710|Secondary|Change in Triglycerides (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
54487|NCT01269710|Secondary|Change in Total Cholesterol (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
54488|NCT01269710|Secondary|Change in Glucose Levels (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||mg/dL||Standard Deviation|Mean
54489|NCT01269710|Primary|Change in Weight (in Lbs.)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.||lbs.||Standard Deviation|Mean
54490|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|4 weeks after a positive pregnancy test|In order to handle the problem of small sample size bootstrap techniques are used. Ader et al recommend bootstrap procedures(a) distribution is complicated or unknown, (b) a small sample is available. Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||Percentage||95% Confidence Interval|Mean
54491|NCT01269125|Secondary|Follicular Fluid's TNF-a Concentration.|TNF-a was measured in the FF of all women (secondary outcome measures). To prevent any cytokine alterations, only blood-free samples were used.|June 2004-August 2010|||pg/ml||Standard Deviation|Mean
54492|NCT01269125|Primary|Fertilization Rate (Percentage of Fertilized Oocytes).|The fertilization rate was estimated for every woman 24 hours after oocyte retrieval|June 2004-August 2010|||percentage||95% Confidence Interval|Mean
54493|NCT01269125|Primary|Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).|Embryo development was evaluated 2 days after oocyte pick-up. The number of blastomeres and the proportion of embryo volume occupied by fragments were used for the evaluation. Embryos with < 10%, < 10-20%, < 20-30% and >30% fragments were estimated as grade 1,2,3 and 4, respectively.|June 2004-August 2010|||Percentage of grade 1 embryos||95% Confidence Interval|Mean
54494|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|June 2004-August 2010|The study period was seven years. Practical issues such as, no more funds for measuring cytokines, my transportation to different University stopped this study before reaching adequate power. The flow of the participants in our Department was low.||percentage||95% Confidence Interval|Mean
54495|NCT01268943|Primary|Dose Related Toxicity|dose related toxicity is defined as follows:1. WBC damage >= grade 3; granular cell decrease >= grade 3; hemoglobin >= grade 2; platelet >= grade 2;SGPT/SGOT elevation >= grade 2; ALP >= grade 2; GGT >= grade 2; Tbil >= grade 2;renal function damage: BUN/Cr elevation >= grade 2;Non-gradular cell decreased fever >= grade 2;nausea/vomiting >= grade 2; fatigue >= grade 3; weight loss >= grade 3;gastritis >= grade 3; dairrea >= grade 3; abdominal pain >= grade 3; pancreatitis >= grade 2; upper gastrointestinal bleeding >= grade 2;other toxic reaction >= grade 3;KPS < 50 during the treatment|up to 9 weeks|||event|||Number
54496|NCT01268891|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson’s Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF||units on a scale||Standard Error|Mean
61766|NCT01191190|Secondary|Treatment-Free Survival||2 years|||months||Full Range|Median
54497|NCT01268891|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF||units on a scale||Standard Error|Mean
54498|NCT01268891|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 18|FAS; last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
54499|NCT01268891|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson’s Disease Patient Diary|"Parkinson’s Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.~The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time."|Baseline and Weeks 6, 10, 14, and 18|Full-analysis set (FAS); observed cases (OC)||hours||Standard Error|Mean
54500|NCT01268683|Secondary|Clinical and MRI Outcome Data|The proportion of subjects with mRS <=4 expressed as a % (total number of patients with mRS <=4 divided by total number of patients enrolled).|90 days|||percentage of participants|||Number
54501|NCT01268683|Secondary|Pharmacokinetics/Pharmacodynamics|The number of patients with unanticipated PK or PD responses was assessed. An unanticipated PK or PD response would have been, for instance, a peak concentration inconsistent with prior PK assessments, or an unexpectedly low blood glucose level (< 40 mg/dL)|3 days|||participants|||Number
54502|NCT01268683|Secondary|Safety and Tolerability|"AE's of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all SAE's will be followed for 90 days.~SAE's and AE's were reviewed, and the number of subjects with unanticipated adverse events, or drug-related SAE's were assessed."|90 days|||participants|||Number
54503|NCT01268683|Primary|Rate of Recruitment|The number of months it took to enroll the 10 patients|11 months|||months|||Number
54504|NCT01268501|Primary|Overall Convenience With Contact Lenses|"Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, very satisfied or satisfied."|3 weeks of wear|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review.||Percentage of participants||95% Confidence Interval|Number
54505|NCT01268488|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|158 BG results-78 subjects tested 2 strip lots;2 subjects tested 1 strip lot. 7 subjects-Low BG results disallowed forearm testing per protocol. 1 subject-Missing data. Remainder same as 'palm' analysis population description.||Number of BG Test Results|Participants||Number
54506|NCT01268488|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects(1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|97 participants analyzed: one subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated. For palm and forearm testing tasks, 2 additional subjects (with nonevaluable BG data) were not included. Only 95 participants were rated for those particular tasks.||participants|||Number
54507|NCT01268488|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|161 BG results-80 subjects tested 2 strip lots;1 subject had 1 reading. Withdrawn by PI- 3 subject Adverse Events before performance testing;1 subject did not meet inclusion/exclusion. 6 subjects- Data not evaluable:exceeded time between meter testing and reference method. 7 subjects-Low bg results disallowed palm testing per protocol.||Number of BG Test Results|Participants||Number
54508|NCT01268488|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|178 BG results possible-88 subjects tested 2 strip lots(88x2)/2 subjects had 1 reading(2x1). Withdrawn by Principal Investigator(PI)-3 subjects experienced Adverse Events before performance testing / one subject did not meet inclusion/exclusion. Data from 4 subjects were not evaluable since exceeded time between meter testing and reference method.||Number of BG Test Results|Participants||Number
54509|NCT01268306|Primary|Number of Participants Wiith Corneal Staining|The number of participants who have disturbance of their corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy. Clinically significant staining is described as sufficiently diffuse and deep to pose potential risk of infection by the examiners assessment.|2-4 hours after contact lens insertion|Subjects who returned for examination post-challenge in the allotted time and who had observable corneal staining on slit lamp examination||participants|||Number
54510|NCT01268293|Primary|Number of Participants With Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).|Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).|The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.||Participants|||Number
54511|NCT01268293|Primary|Number of Participants With Dose Limiting Toxicity (DLT)||Up to 4 weeks|Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.||Participants|||Number
54512|NCT01268267|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.||Number of BG test results|Participants||Number
54513|NCT01268267|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 participants were rated for those particular tasks.||participants|||Number
54514|NCT01268267|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.||Number of BG test results|Participants||Number
54515|NCT01268267|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available.||Number of BG test results|Participants||Number
54516|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 12|||units on a scale||Standard Deviation|Mean
54517|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 10|||units on a scale||Standard Deviation|Mean
54518|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 8|||units on a scale||Standard Deviation|Mean
54519|NCT01268189|Secondary|Pain Perceived by Patient|Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.|Post-Operative Day 4|||units on a scale||Standard Deviation|Mean
54520|NCT01268189|Primary|Healing Time for Donor Site Wounds|Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.|number of days to healing|||days||Standard Deviation|Mean
54530|NCT01267994|Primary|To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease|The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.|180 days|||responders|||Number
58184|NCT01227993|Secondary|Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years||||||
54521|NCT01268150|Other Pre-specified|To Assess the Incidence of Adverse Events (AEs) of Eribulin Mesylate|Treatment-emergent adverse events (TEAEs) were defined as AEs that emerged during treatment, having been absent at pretreatment, and occurring within 30 days of the last dose of study treatment, or if they were present prior to the first dose administration and increased in severity during the study. For each AE a participant with two or more TEAEs in that category were counted only once. TEAEs were considered related if the relationship of the event to study drug was possibly or probably related. Serious adverse events (SAEs) were defined as any untoward medical experience that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. Safety information will be summarized with adverse events. AEs were graded on a five-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline until End of Treatment (within 21 days of last dose), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Safety Analysis Set population included all participants who received at least one dose of study drug and had at least one postbaseline safety assessment.||Percentage of participants|||Number
54522|NCT01268150|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment. Participants without evidence of PD upon discontinuation of study drug during the Extension Phase returned to the clinic for disease evaluation and PFS calculation every 12 weeks until PD was documented. PFS was analyzed using Kaplan-Meier product-limit estimates. This statistical analysis method measures the effect of study drug on PFS.|Treatment Phase (Day 1 Cycle 1) to date of progressive disease or death, whichever occurred first, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.||Months||95% Confidence Interval|Median
54523|NCT01268150|Secondary|Duration of Response|Duration of response was measured for participants who were responders only, had attained a BOR that was CR or PR. The duration of response was measured from time that response criteria for CR or PR (whichever was recorded first) were first met until the date that progressive disease (PD) or death from any cause was first objectively documented. Participants who did not have PD were censored on the day of their last tumor assessment. Duration of response was summarized for the responders using Kaplan-Meier estimation method. This statistical analysis method measures the effect of study drug on the length of response time.|First date of CR or PR to PD or Death from any cause, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.||Months||95% Confidence Interval|Median
54524|NCT01268150|Secondary|Time to First Response (CR or PR)|Time to first response was defined for participants whose BOR was a CR or PR. Analysis was based on the Kaplan-Meier estimated number of months to CR or PR. This statistical analysis method measures the effect of study drug on CR or PR.|Treatment Phase (Day 1 Cycle 1) to earliest date of confirmed objective response (CR or PR), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.||Months||95% Confidence Interval|Median
54525|NCT01268150|Primary|Objective Response Rate (ORR)|The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR|Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.||Percentage of participants|||Number
54526|NCT01268111|Primary|M Value (Insulin Stimulated Glucose Uptake)|Insulin stimulated glucose uptake will be measured by glucose clamp studies|Baseline and at 8 weeks|||mg/kg.min||Standard Deviation|Mean
54527|NCT01268098|Secondary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.||percentage of participants||95% Confidence Interval|Number
54528|NCT01268098|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.|The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.||percentage of participants||95% Confidence Interval|Number
54529|NCT01267994|Secondary|To Assess the Safety and Tolerability of a Three Month (84 Day) Course of Anakinra in Corticosteroid Resistant Patients With Autoimmune Inner Ear Disease.||84 days||||||
54941|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54531|NCT01267929|Primary|The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.|The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates < 10% of activity,2=partially completes 10% to < 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.|Base line, two months and six months|A total of 30 children with cerebral palsy was followed and completed the study.||Scores on a scale||Standard Deviation|Mean
54532|NCT01267422|Secondary|Computerized Visual Field(VFI: Visual Field Index ,the Value Close to 100% Regarded Normal)|VFI: visual field index ,the value Close to 100% regarded normal. VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are VFI outcome measure of 8 patients.||Percentage of normal||Standard Deviation|Mean
54533|NCT01267422|Secondary|Computerized Visual Field(MD: Mean Deviation, the Value Close to 0 Regarded Normal)|MD: mean deviation, the value Close to 0 regarded normal.VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are MD outcome measure of 8 patients.||dB||Standard Deviation|Mean
54534|NCT01267422|Secondary|Average RNFL Thickness Througth Optical Coherence Tomography(OCT) Test|Average RNFL thickness of 8 patients througth Optical coherence tomography(OCT) test before and after treatment|Up to 3 years|RNFL thickness of 8 patients except Patient 1 because he once accepted the other eye's treatment||Micrometer||Standard Deviation|Mean
54535|NCT01267422|Secondary|Neutralizing Antibody Assay|The mean of Neutralizing antibody assay of 8 patients before and after treatment|up to 3 years|Neutralizing antibody assay of 8 patients except Patient 1 because he once accepted the other eye's treatment||titer||Standard Deviation|Mean
54536|NCT01267422|Secondary|Intraocular Pressure;||Up to 3 years|||mmHg||Full Range|Mean
54537|NCT01267422|Primary|Results of CD3/CD4/CD8 Test|The mean percentage of CD3+/CD4+/CD8+ test before and after treatment|up to 6 months|||Percentage of total cells||Full Range|Mean
54538|NCT01267422|Primary|The Best Corrected Visual Acuity(BCVA)||Up to 3 years|The data are expressed as mean±standard error. Comparisons before and after treatment of the BCVA were analyzed using the paired t-test.A probability (P) value of less than 0.05 was considered statistically significant.Lower logMAR represents a better outcome.||logMAR|Participants|Standard Error|Mean
54539|NCT01267266|Secondary|Correlation of Molecular Profile With Clinical Outcomes|Study terminated after randomization of only 8 subjects. Correlative data not analyzed.|Up to 2 years||||||
54540|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events.|Percentage of patients who discontinued therapy due to toxicity.|Up to 6 months.|||percentage of participants||95% Confidence Interval|Number
54541|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events|Percentage of patients with grade 4 toxicity.|Up to 6 months.|||percentage of participants||95% Confidence Interval|Number
54542|NCT01267266|Primary|Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)|Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.|Up to 6 months.|Two patients in the placebo arm censored at 12 and 17 weeks, respectively.||weeks||Full Range|Median
54543|NCT01267253|Other Pre-specified|Serum Expression Levels of Surrogate Markers of Brivanib Alaninate Effects Including Angiogenic Factors (VEGF and bFGF) and Markers of Endothelial Damage (E-selectin, VCAM-1, and ICAM-1)|Surrogate markers will be associated with response, PFS, and OS.|Up to 5 years||||||
54544|NCT01267253|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact..|From study entry to time of death or the date of last contact, up to 5 years of follow-up.|Eligible and Treated Patients||Months||95% Confidence Interval|Median
54545|NCT01267253|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up|Eligible and Treated Participants||Months||95% Confidence Interval|Median
54546|NCT01267253|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v.4.0|During treatment period and up to 30 days after stopping the study treatment.|Eligible and Treated Participants||Participants|||Number
54547|NCT01267253|Primary|PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry.|Proportion of participants who survive progression-free for at least 6 months without non-protocol therapy from study entry. Progression is assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months therafter until disease progression confirmed; and at any other time if cliniclly indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and treated participants||percentage||90% Confidence Interval|Number
54548|NCT01267253|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated participants||percentage||90% Confidence Interval|Number
54549|NCT01267227|Secondary|Subjective Adverse Effects|Number of participants with adverse effects as a measure of safety|Baseline and 6-8 weeks|||participants|||Number
54550|NCT01267227|Secondary|Blood Pressure|Change in baseline systolic blood pressure and/or diastolic blood pressure|6-8 weeks||||||
54551|NCT01267227|Primary|Triglycerides|Change in baseline triglycerides (TG)|Baseline and 6-8 weeks|||mg/dL||Full Range|Mean
54552|NCT01267201|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||hr||Standard Deviation|Mean
54555|NCT01267201|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
54556|NCT01267175|Secondary|Usability of the Training Material Meets Expectations|Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly.|5 weeks|||Scores on a scale||Standard Deviation|Mean
54557|NCT01267175|Primary|Usability of the X54 Insulin Pump Meets Expectations|Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.|5 weeks|||Scores on a scale||Standard Deviation|Mean
54558|NCT01267136|Secondary|Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.|Parent-reported side effects entered in 10-day diary.|Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.|||participants|||Number
54559|NCT01267136|Primary|Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.|Average number of post-operative days with pain score >4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).|Efficacy was assessed daily during the 10-day postoperative recovery period.|||days||Full Range|Median
54560|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. “I disapprove of myself when I have irrational ideas”) by indicating how often they agree with the statement on a scale of 1 (“never or very rarely true”) to 5 (“very often or always true”). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.|8 months|||units on a scale||Standard Deviation|Mean
54561|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. “I disapprove of myself when I have irrational ideas”) by indicating how often they agree with the statement on a scale of 1 (“never or very rarely true”) to 5 (“very often or always true”). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.|2 months|||units on a scale||Standard Deviation|Mean
54562|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. “How often did you feel tired?) with the following scale:~= never~= rarely~= sometimes~= often~= always~Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|8 months|||T-score||Standard Deviation|Mean
54563|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. “How often did you feel tired?) with the following scale:~= never~= rarely~= sometimes~= often~= always~Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|2 months|||T-score||Standard Deviation|Mean
54564|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. “Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?”) by indicating how often per week he or she experiences that symptom. For each item, “not at all” is scored as 0; “once per week or less/a little” is scored as 1; “2 to 4 times per week/somewhat” is scored as 2; and “5 or more times per week/very much” is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
54565|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. “Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?”) by indicating how often per week he or she experiences that symptom. For each item, “not at all” is scored as 0; “once per week or less/a little” is scored as 1; “2 to 4 times per week/somewhat” is scored as 2; and “5 or more times per week/very much” is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
54566|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. “feeling tired or having little energy”), from “not at all” (0), to “nearly every day” (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
54567|NCT01267045|Primary|Cognitive Failures Questionnaire|The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. “Do you find you forget why you went from one part of the house to another?”), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
61767|NCT01191190|Secondary|Progression-free Survival (PFS)||2 years|||months||Full Range|Median
54568|NCT01267045|Primary|Cognitive Failures Questionnaire|The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. “Do you find you forget why you went from one part of the house to another?”), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
54569|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|8 months|||units on a scale||Standard Deviation|Mean
54570|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|2 months|||units on a scale||Standard Deviation|Mean
54571|NCT01267045|Primary|The Short-Form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|8 months|||units on a scale||Standard Deviation|Mean
54572|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. “feeling tired or having little energy”), from “not at all” (0), to “nearly every day” (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
54573|NCT01267045|Primary|The Short-form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|2 months|||units on a scale||Standard Deviation|Mean
54574|NCT01266967|Secondary|Number of Response Genetics Incorporated (RGI) Investigational Use Only (IUO) Assay Mutation Positive Participants and THxID BRAF Assay Mutation Positive Participants With the Indicated Best Intracranial Response|The BRAF screening assay determines the specific BRAF mutational status (V600 E and K) in participants with metastatic melanoma who may benefit from treatment with GSK2118436. Per RECIST, version 1.1, CR is defined as the disappearance of all lesions. PR is defined as a >=30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline (BL) sum of the diameters (e.g., percent change from BL). Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a >=20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir [smallest sum of diameters recorded since treatment start]). In addition, the sum must have an absolute increase from nadir of 5 millimeters. Not evaluable: cannot be classified by a preceding definition.|Screening|V600EK and THIDEK Population: all enrolled participants who were V600E or V600K mutation positive by the RGI IUO assay||participants|||Number
54575|NCT01266967|Secondary|Composite of Pharmacokinetic Parameters of GSK2118436 in a Subset of Participants Receiving Dexamethasone|This outcome measure could not be analyzed because too few participants participated in the dexamethasone study.|Day 15||||||
54576|NCT01266967|Secondary|Median Concentrations of GSK2118436 and Its Metabolites Including GSK2285403, GSK2298683, and GSK2167542|Summary statistics were calculated for each time point by cohort. The population pharmacokinetics were determined using a non-linear mixed effects modeling approach after pooling the data with other studies. These results are reported separately.|Week 4 (pre-dose and 1-3 hours post-dose) and Weeks 8, 16, 24, and 32 (either pre-dose in the morning or in the afternoon at 4-8 hours post-dose)|PK Population: participants in the ATS population for whom a PK sample was obtained and analyzed. Only those participants whose samples were available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Full Range|Median
54577|NCT01266967|Secondary|Number of Participants With Abnormal Echocardiograms (ECHO) at Weeks 4 and 12|Echocardiograms (ECHO) were measured for all treated participants. An echocardiogram test gives information about the structure and function of the heart. LLN=lower limit of normal (determined by the institution).|Weeks (W) 4 and 12|ATS Population||participants|||Number
54578|NCT01266967|Secondary|Number of Participants With a Worst-case On-therapy Increase From Baseline in Bazett's QTc Reading in the 12-lead Electrocardiogram (ECG)|An increase in the QTc interval corrected using Bazett's formula (Bazett's QTc) was recorded for all treated participants. Grade 1 (450-480 milliseconds [msec]), Grade 2 (481-500 msec), Grade 3/4 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade.|Baseline; Weeks 4, 12, 20, 28, 40, 52, and 64|ATS Population. Only those participants with data available at the indicated time points were analyzed.||participants|||Number
54579|NCT01266967|Secondary|Mean Blood Pressure at Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|Systolic and diastolic blood pressure were measured for all treated participants.|Baseline; Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|ATS Population. Only those participants with data available at the indicated time points were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
54608|NCT01266876|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint..|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment HDL-C value.||percent change||Standard Error|Least Squares Mean
54942|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54580|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Hematology Parameters|Hematology data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe, Grade 4, life threatening, Grade 5, death related to toxicity. Blood sample was collected for the assessment of hemoglobin, white blood cells, and platelet count.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.||participants|||Number
54581|NCT01266967|Secondary|Number of Participants With the Indicated Hepatobiliary Laboratory Abnormalities|Blood samples were collected for the assessment of hepatobiliary parameters. ALT=alanine aminotranserase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; BIL=total bilirubin; INR=international normalized ratio; ULN=upper limit of normal. Hepato-cellular injury is defined as (ALT/ULN)/(ALP/ULN) >=5.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population||participants|||Number
54582|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Clinical Chemistry Parameters|Clinical chemistry data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade (G) 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death related to toxicity. Blood sample was collected for the assessment of glucose, potassium, magnesium, sodium, phosphorus, potassium. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatinine, total bilirubin, albumin, amylase, cholesterol, creatine kinase, gamma glutamyl transferase (GGT), lipase, blood pH, and triglycerides.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.||participants|||Number
54583|NCT01266967|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From Screening until the conclusion of the study (up to 103 weeks)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment||participants|||Number
54584|NCT01266967|Secondary|Overall Survival in V600K Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 26 weeks)|V600K Population||months||95% Confidence Interval|Median
54585|NCT01266967|Secondary|Overall Survival of V600E Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 35 weeks)|V600E Population||months||95% Confidence Interval|Median
54586|NCT01266967|Secondary|Progression-free Survival in V600K Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 17 weeks)|V600K Population||weeks||95% Confidence Interval|Median
54587|NCT01266967|Secondary|Progression-free Survival in V600E Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 23 weeks)|V600E Population||weeks||95% Confidence Interval|Median
54609|NCT01266876|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment total cholesterol value.||mg/dL||Standard Error|Least Squares Mean
56576|NCT01247428|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only|8 hours|||percentage of participants||95% Confidence Interval|Number
54588|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600K Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial response was included in this analysis.||weeks||95% Confidence Interval|Median
54589|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600E Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 28 weeks)|V600E Population. Only the subset of participants who had a complete or partial response was included in this analysis.||weeks||95% Confidence Interval|Median
54590|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600K Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.||weeks||95% Confidence Interval|Median
54591|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600E Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 27 weeks)|V600E Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.||weeks||95% Confidence Interval|Median
54592|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With OIR, as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PF) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 16 weeks)|V600K Population||participants|||Number
54593|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 17 weeks)|V600K Population: all participants with BRAF V600K mutation-positive melanoma who received at least one dose of study treatment||participants|||Number
54610|NCT01266876|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment total cholesterol value.||percent change||Standard Error|Least Squares Mean
54594|NCT01266967|Secondary|Number of Participants With V600E Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 24 weeks)|V600E Population||participants|||Number
54595|NCT01266967|Primary|Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PR) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks)|V600E Population: all participants with BRAF V600E mutation-positive melanoma who received at least one dose of study treatment||participants|||Number
54596|NCT01266876|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.||mg/dL||Inter-Quartile Range|Median
54597|NCT01266876|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.||percent change||Inter-Quartile Range|Median
54598|NCT01266876|Secondary|Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B and ApoA-1 value.||ratio||Standard Error|Least Squares Mean
54599|NCT01266876|Secondary|Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.||mg/dL||Standard Error|Least Squares Mean
54600|NCT01266876|Secondary|Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.||percent change||Standard Error|Least Squares Mean
54601|NCT01266876|Secondary|Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.||mg/dL||Standard Error|Least Squares Mean
54602|NCT01266876|Secondary|Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.||percent change||Standard Error|Least Squares Mean
54603|NCT01266876|Secondary|Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.||mg/dL||Standard Error|Least Squares Mean
54604|NCT01266876|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.||percent change||Standard Error|Least Squares Mean
54605|NCT01266876|Secondary|Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.||mg/dL||Inter-Quartile Range|Median
54606|NCT01266876|Secondary|Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.||percent change||Inter-Quartile Range|Median
54943|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54611|NCT01266876|Secondary|Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.||percentage of participants|||Number
54612|NCT01266876|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.||percentage of participants|||Number
54613|NCT01266876|Secondary|Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.||mg/dL||Standard Error|Least Squares Mean
54614|NCT01266876|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.||percent change||Standard Error|Least Squares Mean
54615|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G4P8. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
54616|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3|Blood was collected from all participants prior to vaccination and at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G3. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
54617|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotypes G1, G2, G4P6 and G9. A participant met the threshold of a positive response if the post vaccination antigen-specific antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
54618|NCT01266850|Primary|Geometric Mean Serum Anti-rotavirus IgA Titer|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Mean
54619|NCT01266850|Secondary|Number of Participants Experiencing Hematochezia at Any Time During the Study|Hematochezia was defined as any stools that are black and tarry; maroon in color; or frank red blood. At each visit, signs of hematochezia were assessed and the participant's parent/guardian was instructed to contact the clinical site at any time if the participant had evidence of hematochezia.|Day 1 through 6 months after the last vaccination|All participants who were vaccinated are included in the analysis population.||participants|||Number
54620|NCT01266850|Secondary|Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination|The participants' parent/guardian was given a memory aid to record for 8 days the presence of solicited reactions of fever, diarrhea and vomiting. Fever was considered experienced if the participant was assessed with an axillary temperature of 100.4F or greater on any day in the 8-day period after any vaccination. Diarrhea was considered experienced if the participant had 3 or more looser than normal stools in a day. Vomiting was considered experienced if the participant vomited 2 or more times in a day.|Days 1-8 after each vaccination|All participants who were vaccinated and had reactogenicity data reported are included in the analysis population.||participants|||Number
54621|NCT01266850|Secondary|GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9)|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the neutralizing antibody assay against the most common rotavirus serotypes, G1-G4 and G9. Antigen-specific geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||titers||95% Confidence Interval|Mean
54649|NCT01266070|Secondary|Number of VHL Participants With Response at 6 Months|Efficacy of treatment with dovitinib for 6 months in patients with VHL who have a measurable lesion evaluated by response using RECIST (Response Evaluation Criteria in Solid Tumors): Complete Response, Partial Response, Progressive Disease or Stable Disease.|Every 2 cycles (approximately 8 weeks) for 6 months|||Participants|||Count of Participants
69355|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||12 months|||participants|||Number
54622|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
54623|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.||participants|||Number
54624|NCT01266824|Secondary|PIPP Score|PIPP score measure immediately following mydriatic drop administration|within 5 minutes after Mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
54625|NCT01266824|Secondary|Bradycardia/Desaturation|Number of episodes of bradycardia (HR 90) and significant desaturation (event requiring stimulation, per Neonatal Intensive Care Unit (NICU) protocol, to resolve) occurring after the administration of mydriatic and proparacaine eye drops|Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
54626|NCT01266824|Secondary|PIPP Score|PIPP scores measure immediately after Proparacaine administration|within 5 minutes after Proparacaine administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
54627|NCT01266824|Primary|Change in PIPP Score|Comparison of the change in Premature Infant Pain Profile (PIPP) scores from baseline to the time immediately following mydriatic drop administration between the groups of infants who do and do not receive Proparacaine eye drops prior to mydriatic drops. The PIPP score is a scale to determined pain response that was designed for use in preterm and term infants. It is based on both physiologic and behavioral changes exhibited by infants during the study period of 30s (facial changes, HR, O2 saturation). There are correction factors for gestational age and baseline state at time of scoring. Scores can range from 0-21 with the maximum score dependent on the infant's gestational age. A score >7 typically indicates a pain response while a score >12 indicates more severe pain.|Change from baseline to time immediately following mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.|||||
54628|NCT01266447|Secondary|Duration of Objective Response|Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated Patients with objective response||Months||Full Range|Median
54629|NCT01266447|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
54630|NCT01266447|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
54631|NCT01266447|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.|During treatment period and up to 30 days after stopping the study treatment.|Eligible and treated patients - No statistical analysis provided for adverse events (grade 3 or higher) during treatment period.||Participants|||Number
54632|NCT01266447|Primary|Number of Patients With Dose-limiting Toxicities (in Safety lead-in)|A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.|Up to 21 days|The first 6 eligible and treated patients who completed the 1st cycle of study treatment or had a DLT prior to completing the first cycle of study treatment||participants|||Number
54633|NCT01266447|Primary|Tumor Response|Complete and Partial Tumor Response as Assessed by RECIST 1.1|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
54634|NCT01266265|Primary|Prevalence of Respiratory Tract-Related Adverse Events of Interest|Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.|Follow-up every 3 months|||percentage of participants|||Number
54645|NCT01266148|Primary|Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation|Measured Glomerular Filtration Rate (mGFR) describes the flow rate of filtered fluid through the kidney. GFR is equal to the clearance rate when any solute is freely filtered and is neither reabsorbed nor secreted by the kidneys. The rate therefore measured is the quantity of the substance in the urine that originated from a calculable volume of blood. Participants’ urine was used for this assessment at week 52 after heart transplant.|Week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mGFR ml/min||Standard Deviation|Mean
69356|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||30 days|||participants|||Number
54635|NCT01266148|Secondary|Change in Quality of Life - Euro Quality of Life 5D (EQ-5D)|Change in Quality of Life was assessed via the EQ-5D questionnaire which consists of: EQ-5D-5L descriptive system and EQ Visual Analogue scale (EQ VAS). The EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The patient indicates his/her health state by checking the most appropriate statement. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions are combined in a 5-digit number describing the respondent’s health state. The possible score is 1 to 5 where a lower number indicates improvement. The EQ VAS records the patient’s self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. The score is 0 to 100 where a higher score represents improvement.|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||Units on a scale||Standard Deviation|Mean
54636|NCT01266148|Secondary|Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment|Change in Quality of Life was assessed via the SF-36 (Minnesota Living with Heart Failure questionnaire ([MLHF)]) before transplant surgery and at week 52 of treatment. The SF-36 is a validated, self-administered questionnaire. The questionnaire, which includes 36 questions measures 8 dimensions of health: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. Scores can be summarized in 2 summary components assessing physical and mental health. Items in each dimension are coded, aggregated, summed, and transformed into a scale ranging from 0 (worse health) to 100 (best health).|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||Units on a scale||Standard Deviation|Mean
54637|NCT01266148|Secondary|Lipid Profile at 12 Months|Total Cholesterol, LDL-Chol, HDL-Chol and TG at week 52. Measurements were taken via participants blood samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and had blood samples taken at week 52.||mmol/L||Standard Deviation|Mean
54638|NCT01266148|Secondary|Average Level of Protenuria at Week 52|Proteinuria is measured as the ratio of albumin/creatinine mg/mmol. Measurements were taken from participants urine samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and were able to provide urine samples at week 52.||mg/mmol||Standard Deviation|Mean
54639|NCT01266148|Secondary|Occurrence of Treatment Failures up to 12 Months After Transplant|Treatment failure was defined as the number of participants who died or lost their graft at any timepoint througout the duration of the study.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||participants|||Number
54640|NCT01266148|Secondary|Number of Rejections Leading to Hemodynamic Compromise|Number of all rejections were recorded through the duration of the study with the intent to identify rejections leading to hemodynamic compromise.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||rejections|||Number
54641|NCT01266148|Secondary|Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52|Calculated Glomerular Filtration Rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end of week 52.|Day 1, weeks 7 to 11 and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mGFR mL/min||Standard Deviation|Mean
54642|NCT01266148|Secondary|Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52|Change in calculated glomerular filtration rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end week 52.|Day 1, weeks 7 to 11(baseline) and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mGFR mL/min||Standard Deviation|Mean
54643|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52|the progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examinations, measured the incidence of CAV (in percent of patients) at baseline and at week 52. Incidence of CAV represents percent of patients having a MIT (maximal intima thickness) > 0.5 mm.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||Percentage of patients|||Number
54644|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52|The progression of chronic allograft vasculopathy (CAV) was assessed by intravascular ultrasound (IVUS) examinations and measured Maximal Intimal Thickness (MIT)(in mm). A major coronary epicardial artery (preferentially the left-anterior descending coronary artery) was imaged, and the MIT parameters were recorded at baseline and at week 52.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.||mm||Standard Deviation|Mean
69357|NCT01116882|Secondary|All Cause Mortality at 12 Months||12 months|||participants|||Number
54650|NCT01266070|Primary|Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months|Most frequent & Most Serious Adverse Events: Safety of treatment with Dovitinib for 6 months in participants with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.|Every 2 cycles (approximately 8 weeks) for 6 months|||Participants|||Count of Participants
54651|NCT01266031|Secondary|Radiological Response|Magnetic resonance imaging (MRI) and contrast-enhanced (CE) MRI was used to evaluate tumor response. Response is defined by the Modified MacDonald criteria. Complete Response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. Partial Response, Non-Measurable (PRNM) is not applicable. Stable/No Response does not qualify for CR, PR or progression. Progression is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).|End of therapy||01/2017||||
54652|NCT01266031|Secondary|Mean Symptom Interference at the Time of Clinical Evaluation|"Proportion of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the anlyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy||01/2017||||
54653|NCT01266031|Secondary|Mean Core Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool|"Proportion of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the anlyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy||01/2017||||
54654|NCT01266031|Secondary|Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT)|"Proportion of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the anlyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy||01/2017||||
54655|NCT01266031|Secondary|Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis|About 5cc of blood was collected to measure plasma angiogenic proteins vascular endothelial growth factor (VEGF), placental growth factor (PIGF), basic fibroblast growth factor (bFGF), stromal cell-derived factor α (SDF1α), angiopoietin 1 and 2 by enzyme-linked immunosorbent assay (ELISA).|Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)||01/2017||||
54656|NCT01266031|Secondary|Overall Survival (OS)|Time between the first day of treatment to the day of death.|Time between the first day of treatment to the day of death.||01/2017||||
54657|NCT01266031|Secondary|Time to Progression (TTP)|Time between the first day of treatment to the day of disease progression.|Time between the first day of treatment to the day of disease progression.||01/2017||||
54658|NCT01266031|Primary|Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab|MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), using conventional Phase I design where the MTD was selected using a 3+3 accrual design at each dose level until MTD was determined. Toxicities will be graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0.|28 day, cycle 1|||mg/day|||Number
54659|NCT01266031|Primary|Progression Free Survival (PFS) at 6 Months|"PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year.~Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial.~Study outcome measure period ended June 2015."|Baseline until disease progression or death due to any cause, up to six months|Of the 90 participants (Bev+V: 49, Bev: 41) enrolled, 83 were evaluable for the primary endpoint (Bev+V: 46, Bev: 37).||Months||95% Confidence Interval|Median
54660|NCT01265992|Secondary|Number of Participants Using Concomitant Medications at Baseline||Baseline|Full analysis set||participants|||Number
54661|NCT01265992|Secondary|Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism|"Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days.~Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment.~Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature."|6 months|Participants who were working for pay and with available data at both time points.||Swedish krona per participant||Standard Deviation|Mean
54662|NCT01265992|Secondary|Total Direct Costs of Care Associated With Secondary Hyperparathyroidism|Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation.|6 months||||||
54682|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of >1 for men and >0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT population||percentage of participants|||Number
54663|NCT01265992|Secondary|Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)|"The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 (worst possible health) to 10 (best possible health).~Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life."|Baseline and 6 months|Per-protocol analysis set with available data at both time points.||units on a scale||Standard Deviation|Mean
54664|NCT01265992|Secondary|Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline||Baseline and 6 months|Per-protocol analysis set. Percentages are based on the total number of participants in the per-protocol analysis set.||percentage of participants|||Number
54665|NCT01265992|Secondary|Change From Baseline in Proteinuria|Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine.|Baseline and Month 6|Per-protocol analysis set with available data at both time points.||g/L||Standard Deviation|Mean
54666|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months|Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.|Baseline and 6 months|Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).||percentage of participants|||Number
54667|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months|"Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as:~Stage 3 CKD: ≥ 1.49 mmol/L;~Stage 4 CKD: ≥ 1.49 mmol/L;~Stage 5 CKD: > 1.78 mmol/L."|Baseline and 6 months|Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).||percentage of participants|||Number
54668|NCT01265992|Primary|Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months|"Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are:~Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 – 59 mL/min): 3.85 – 7.7 pmol/L;~Stage 4 CKD (eGFR 15 – 29 mL/min): 7.7 – 12.1 pmol/L;~Stage 5 CKD (eGFR < 15 mL/min): 16.5 – 33 pmol/L.~*Calculated using the Modification of Diet in Renal Disease formula."|Baseline and 6 months|Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40).||percentage of participants|||Number
54669|NCT01265992|Primary|Change From Baseline in Intact Parathyroid Hormone at 6 Months||Baseline and 6 months|Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points.||pmol/L||Standard Deviation|Mean
54670|NCT01265966|Primary|Change From Baseline to Peak Salivary Cortisol Level|Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.|Baseline, then every 30 minutes, and at end of procedure|All patients with adequate samples for analysis.||Number (ratio of peak to baseline)||Standard Error|Mean
54671|NCT01265875|Secondary|VAS Score at Each Administered Dose.|10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.|Days 1, 2, and 3.|||units on a scale||Standard Deviation|Mean
54672|NCT01265875|Primary|Quality of Life at Baseline, Day 4 and Day 30.|Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.|Baseline, Day 4, Day 30.|||units on a scale||Standard Deviation|Mean
54673|NCT01265875|Primary|Opiate Use at Baseline, Days 4 and 30.|Daily opiate use (oral morphine equivalent).|Baseline, Day 4, Day 30.|||mg/day||Standard Deviation|Mean
54674|NCT01265875|Secondary|Number of Participants With Serious Adverse Events.||30 Days|||participants|||Number
54675|NCT01265875|Primary|VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.|10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.|Baseline, Days 1, 2, 3, 4, 7, 30.|||units on a scale||Standard Deviation|Mean
54676|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 16|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 16|Participants with available data at given time points.||pg/mL||Standard Deviation|Mean
54677|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 16|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 16|Participants with available data at given time points.||nmol/L||Standard Deviation|Mean
54678|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 16|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 16|Participants with available data at given time point.||ng/mL||Standard Deviation|Mean
54679|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 4|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 4|Participants with available data at given time points.||pg/mL||Standard Deviation|Mean
54680|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 4|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 4|Participants with available data at given time points.||nmol/L||Standard Deviation|Mean
54681|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 4|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 4|Participants with available data at given time points.||ng/mL||Standard Deviation|Mean
54683|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT Population||percentage of participants|||Number
54684|NCT01265823|Secondary|Mean Homocysteine Levels at Baseline and Week 16|Normal values for homocysteine were 5-13.9 µmol/L.|Baseline, Week 16|Participants with available data at given time points.||µmol/L||Standard Deviation|Mean
54685|NCT01265823|Secondary|Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16|Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.|Baseline, Week 16|Participants with available data at given time points.||mg/dL||Standard Deviation|Mean
54686|NCT01265823|Secondary|Physician’s Global Assessment (PGA) at Week 16|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present). The number of participants who achieve a PGA of 'clear' or 'almost clear' at Week 16 was a secondary outcome measure in this study.|Week 16|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
54687|NCT01265823|Secondary|Physician's Global Assessment (PGA) at Week 4|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).|Week 4|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
54688|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 16|ITT population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
54689|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 4|ITT population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
54690|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 16|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
54691|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 4|ITT population. Participants with missing scores were considered nonresponders.||participants|||Number
54692|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 16|Participants with evaluable data at given time points.||units on a scale||Standard Deviation|Mean
54718|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.||participants|||Number
54693|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 4|Participants with evaluable data at given time points.||units on a scale||Standard Deviation|Mean
54694|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
54695|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant’s life.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
54696|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
54697|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.||percentage of participants|||Number
54698|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and open label month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|Score recorded at the end of run-in and open label month|||score on a scale||95% Confidence Interval|Mean
54699|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and blinded month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|recorded at the end of run-in month and blinded month|||score on a scale||95% Confidence Interval|Mean
54700|NCT01265797|Secondary|Somatic Symptom Score (Patient Health Questionnaire-15)|"Mean difference in PHQ 15 score between run-in month and open label month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms."|28 day period in run-in month and open label month|||score on a scale||95% Confidence Interval|Mean
54701|NCT01265797|Secondary|Somatic Symptom Severity (Patient Health Questionnaire 15)|"Mean difference in PHQ 15 score between run-in month and blinded month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms"|28 days recall; measured at end of run-in month and blinded month|||score on a scale||95% Confidence Interval|Mean
54702|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and open label month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 day recall, recorded at the end of run-in and open label months|||score on a scale||95% Confidence Interval|Mean
54703|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and blinded month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 days recall; measured at end of run-in month and blinded month|||score on a scale||95% Confidence Interval|Mean
58185|NCT01227993|Secondary|Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years||||||
54704|NCT01265797|Secondary|Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)|Mean difference in HIT-6 score between run-in month and open label month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|28 day period in run-in month and open label month|||score on a scale||95% Confidence Interval|Mean
54705|NCT01265797|Secondary|Headache Impact Test-6|Mean difference in HIT-6 score between run-in month and blinded month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|after run-in month, after blinded month|||score on a scale||95% Confidence Interval|Mean
54706|NCT01265797|Primary|Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)|Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 days recall; measured at end of run-in month and blinded month|The number of participants included the individuals who have completed the run-in period and the blinded period. The data was analyzed 'per protocol' based on the number of participants completing the blinded period.||depression score/14 day recall||95% Confidence Interval|Mean
54707|NCT01265797|Secondary|Depression Score (Patient Health Questionnaire-9)|Mean difference of PHQ-9 score between the run-in month and open label month, i.e. PHQ-9 score from run-in month minus open label month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 day recall, recorded at the end of run-in and open label months|||score on a scale||95% Confidence Interval|Mean
54708|NCT01265797|Secondary|Headache Days|Mean change in headache days between 28 day run-in month and 28 day open label month, i.e. run-in month mean minus open label month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period in run-in month and open label month|||headache days/ 28 day period||95% Confidence Interval|Mean
54709|NCT01265797|Primary|Mean Headache Days|Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period during run-in month and blinded month|||headache days/ 28 day period||95% Confidence Interval|Mean
54710|NCT01265784|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable AUC(0-12) data.||nanogram*hours per milliliter (ng*h/mL)||Standard Deviation|Mean
54711|NCT01265784|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable Cmax data.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
54712|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
54713|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
54714|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
54715|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit|Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible).|EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
54716|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
54717|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
58335|NCT01227629|Secondary|D-dimer: Difference From Baseline|Difference in D-dimer from baseline to last available value|baseline and 12 weeks|All randomised patients, only per-protocol data included.||ng/ml||Standard Deviation|Mean
54719|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.||participants|||Number
54720|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.||participants|||Number
54721|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit||Follow-Up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
54722|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
54723|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.||participants|||Number
54724|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.||participants|||Number
54725|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.||participants|||Number
54726|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of intra-abdominal infection (IAI). The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.||participants|||Number
54727|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
54728|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
54729|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
54730|NCT01265784|Primary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure [TOC] assessment was not available, death unrelated to cIAI, or some other reason).|TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.||participants|||Number
54731|NCT01265615|Secondary|Coronary Calcium Score|Bone mineral density assessed by dual-energy X-ray absorptiometry (DXA) of the whole body, lumbar spine and hip was performed using Hologic scanners (QDR 1000W or QDR 2000). The total Agatston coronary calcium score (CCS) was measured as the sum of calcified plaque scores of all the coronary arteries. The amount of calcium present in the coronary arteries is scored according to the Agatson scale, as follows: 0 - no identifiable disease; 1 to 99 - mild disease; 100 to 399 - moderate disease; 400 or higher - severe disease.|on day 180|||units on a scale||Standard Deviation|Mean
54732|NCT01265615|Secondary|Systolic Blood Pressure|SBP measured by routine method|on day 180|||mmHg||Standard Deviation|Mean
54733|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Kidney|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180|||fmol VDR/ mg protein||Standard Deviation|Mean
54734|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Myocardium|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180|||fmol VDR/ mg protein||Standard Deviation|Mean
54735|NCT01265615|Secondary|Number of Circulating SP (Side Population) Stem-Progenitor Cells|Renal cells and solid tissue were obtained from the normal portion of cortex obtained from surgically removed kidneys or by standart biopsy on day 180. Cytofluorimetric analysis and immunofluorescence were performed as described by Oliver J.A. (2004). Sorting and analysis of different cells was done on a FACS (fluorescent activated cell sorting) and by flow cytometry. Cells were analyzed with EPICS systems (Beckman Coulter). Quantification of mRNA expression was achieved using Assays-on-Demand gene expression kits and the ABI PRISM 7000 Sequence Detection System (Applied Biosystem).|on day 180|||per cent of SP cells||Standard Deviation|Mean
54736|NCT01265615|Secondary|Serum Creatinine|After an overnight fast, plasma concentrations of hemoglobin, creatinine, cholesterol, glucose, total calcium, and phosphate were measured using an autoanalyzer as described by Adorini L. (2005)|on day 180 after Tx|||mg/dL||Standard Deviation|Mean
54737|NCT01265615|Secondary|CAD (Chronic Allograft Dysfunction) Degree|"CAD degree measured by Banff score after routine renal biopsy (revised 2005/2007 criteria). We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|on day 90|||Scores on a Banff scale||Standard Deviation|Mean
54738|NCT01265615|Secondary|GFR (Glomerular Filtration Rate)|Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated form of the Modification of Diet in Renal Disease (MDRD) study equation: eGFR = exp (5.228 − 1.154 × ln (serum creatinine) − 0.203 × ln (age). Concerning of GFR with Tc99m DTPA renography was used for the complex analysis of renal function. Camera based GFR estimated from Tc99m DTPA renography was named Gates GFR.|on day 180|||ml/min/1.73 m^2||Standard Deviation|Mean
54739|NCT01265615|Secondary|Heart Failure (HF)|"NYHA (New York Heart Association) functional class verified with veloergometry probe and by NYHA clinical classification NYHA Class Symptoms I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.~II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m).~Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|on day 180 after Tx (transplantation)|A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 40 nmol/l) were assigned. Analysis was per protocol.||NYHA functional class of HF||Standard Deviation|Mean
54740|NCT01265615|Primary|CAD (Chronic Allograft Dysfunction) Degree|"Beyond 180 days, chronic allograft dysfunction (CAD) was characterized by mean Banff degree (revised 2005/2007 criteria) with the data of renal biopsy material. Renal tissue was recovered during routined biopsy. We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|day 180 after Tx (transplantation)|||Scores on a Banff scale||Standard Deviation|Mean
54741|NCT01265524|Secondary|6MWT Distance at Week 8|Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||m||Standard Deviation|Mean
54742|NCT01265524|Secondary|Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8||Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||participants|||Number
54743|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.|8 weeks|||participants|||Number
54744|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.|4 weeks|||participants|||Number
54745|NCT01265524|Secondary|Weight Loss at Week 2||Baseline and 2 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||kg||Standard Deviation|Mean
54746|NCT01265524|Secondary|Weight Loss at Week 1||Baseline and 1 week|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||kg||Standard Deviation|Mean
54747|NCT01265524|Primary|Change in Serum Potassium|Change in serum potassium from baseline to Week 8.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||mg/dl||Standard Deviation|Mean
54748|NCT01265498|Secondary|Change in SF-36 Quality of Life Mental Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||units on a scale||Standard Deviation|Mean
54767|NCT01265498|Secondary|Change in Calcium||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
75040|NCT01056718|Secondary|Stress EF||10 Week|||Percent of LV end diastolic volume||Standard Deviation|Mean
54749|NCT01265498|Secondary|Change in SF-36 Quality of Life Physical Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||units on a scale||Standard Deviation|Mean
54750|NCT01265498|Secondary|Change in Diastolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mm Hg||Standard Deviation|Mean
54751|NCT01265498|Secondary|Change in Systolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mm Hg||Standard Deviation|Mean
54752|NCT01265498|Secondary|Change in Waist-to-hip Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||ratio||Standard Deviation|Mean
54753|NCT01265498|Secondary|Change in Waist Circumference||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||cm||Standard Deviation|Mean
54754|NCT01265498|Secondary|Change in Body-mass Index||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||kg/m²||Standard Deviation|Mean
54755|NCT01265498|Secondary|Change in Weight||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||kg||Standard Deviation|Mean
54756|NCT01265498|Secondary|Change in Glycated Haemoglobin A1c||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/mol||Standard Deviation|Mean
54757|NCT01265498|Secondary|Change in HOMA-IR||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||glucose[mmol/L]× insulin[pmol/L] / 22.5||Standard Deviation|Mean
54758|NCT01265498|Secondary|Change in Insulin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||pmol/L||Standard Deviation|Mean
54759|NCT01265498|Secondary|Change in Fasting Serum Glucose||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
54760|NCT01265498|Secondary|Change in International Normalised Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||ratio||Standard Deviation|Mean
54761|NCT01265498|Secondary|Change in Prothrombin Time||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||s||Standard Deviation|Mean
54762|NCT01265498|Secondary|Change in Total Protein||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||gl/L||Standard Deviation|Mean
54763|NCT01265498|Secondary|Change in Albumin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||gl/L||Standard Deviation|Mean
54764|NCT01265498|Secondary|Change in Uric Acid||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||μmol/L||Standard Deviation|Mean
54765|NCT01265498|Secondary|Change in Creatinine||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||μmol/L||Standard Deviation|Mean
54766|NCT01265498|Secondary|Change in Phosphate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
54788|NCT01265498|Secondary|Steatosis: Patients With Improvement|Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0–3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
54768|NCT01265498|Secondary|Change in Bicarbonate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
54769|NCT01265498|Secondary|Change in Platelet Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||platelets *10^9 per L||Standard Deviation|Mean
54770|NCT01265498|Secondary|Change in White Blood Cell Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||white blood cells *10^9 per L||Standard Deviation|Mean
54771|NCT01265498|Secondary|Change in Mean Corpuscular Volume||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||fL||Standard Deviation|Mean
54772|NCT01265498|Secondary|Change in Haematocrit||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||proportion of 1.0||Standard Deviation|Mean
54773|NCT01265498|Secondary|Change in Haemoglobin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||g/L||Standard Deviation|Mean
54774|NCT01265498|Secondary|Change in Triglycerides||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
54775|NCT01265498|Secondary|Change in LDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
54776|NCT01265498|Secondary|Change in HDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
54777|NCT01265498|Secondary|Change in Total Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||mmol/L||Standard Deviation|Mean
54778|NCT01265498|Secondary|Change in Total Bilirubin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||μmol/L||Standard Deviation|Mean
54779|NCT01265498|Secondary|Change in γ-glutamyl Transpeptidase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
54780|NCT01265498|Secondary|Change in Alkaline Phosphatase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
54781|NCT01265498|Secondary|Change in Asparate Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
54782|NCT01265498|Secondary|Change in Alanine Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.||U/L||Standard Deviation|Mean
54783|NCT01265498|Secondary|Portal Inflammation: Change in Score|Change in portal inflammation score. Portal inflammation was assessed on a scale of 0-3, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
54784|NCT01265498|Secondary|Portal Inflammation: Patients With Improvement|Patients with improvement in portal inflammation score. Portal inflammation was assessed on a scale of 0–2, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
54785|NCT01265498|Secondary|Lobular Inflammation: Change in Score|Change in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
54786|NCT01265498|Secondary|Lobular Inflammation: Patients With Improvement|Patients with improvement in lobular inflammation score. Lobular inflammation was assessed on a scale of 0–3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
54787|NCT01265498|Secondary|Steatosis: Change in Score|Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
54789|NCT01265498|Secondary|Hepatocellular Ballooning: Change in Score|Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
54790|NCT01265498|Secondary|Hepatocellular Ballooning: Patients With Improvement|Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0–2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
54791|NCT01265498|Secondary|Total NAFLD Activity Score: Change in Score|NAFLD activity score was assessed on a scale of 0–8, with higher scores showing more severe disease (the components of this measure are steatosis [assessed on a scale of 0–3], lobular inflammation [assessed on a scale of 0–3], and hepatocellular ballooning [assessed on a scale of 0–2]).|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||units on a scale||Standard Deviation|Mean
54792|NCT01265498|Secondary|Fibrosis: Change in Score|Change in fibrosis score. Fibrosis was assessed on a scale of 0–4, with higher scores showing more severe fibrosis.|baseline to 72 weeks|||units on a scale||Standard Deviation|Mean
54793|NCT01265498|Secondary|Fibrosis: Patient With Improvement|Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0–4, with higher scores showing more severe fibrosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
54794|NCT01265498|Secondary|Resolution of NASH Diagnosis|Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks||participants|||Number
54795|NCT01265498|Primary|Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|"Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as:~No worsening in fibrosis; and~A decrease in NAFLD Activity Score (NAS) of at least 2 points"|baseline to 72 weeks|Number of randomly assigned patients with observed or expected week 72 visit before protocol modified on Jan 6, 2014, to eliminate week 72 biopsy. 11 patients in the placebo group and eight in the obeticholic acid group had missing histological data at week 72, and the results for these patients were imputed as a lack of improvement.||participants|||Number
54796|NCT01265459|Secondary|Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)|"The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from very poor=0 to excellent=10."|26 weeks after treatment compared to baseline|||units on a scale||Standard Deviation|Mean
54797|NCT01265459|Secondary|WOMAC Physical Function Score (Change From Baseline)|"The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|||units on a scale||Standard Deviation|Mean
54798|NCT01265459|Secondary|WOMAC Stiffness Score (Change From Baseline)|"The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|||units on a scale||Standard Deviation|Mean
54799|NCT01265459|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.|"Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, Since your last clinical visit have you had any health problems?”."|From baseline to 26 weeks after treatment|||participants|||Number
54800|NCT01265459|Primary|Change of Pain Over 26 Weeks (Change From Baseline)|"The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|"The primary population for all efficacy evaluations was the ITT population (all subjects randomized and treated with study product).~No imputation of missing data was done. Analyses presented were based on observed cases."||units on a scale||Standard Deviation|Mean
54801|NCT01265446|Secondary|Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm). It measures the highest pain level felt by the patient.|Baseline and 240 mn post-dose|intent to treat||mm||95% Confidence Interval|Mean
54802|NCT01265446|Primary|Change From Baseline Sore Throat Pain Intensity|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)|Baseline and 2 hours post-dose|Intent to treat||mm||95% Confidence Interval|Mean
54803|NCT01265420|Primary|Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)||30 days after last injection|||participants|||Number
54804|NCT01265394|Secondary|Measurement of Amyloid Content in Different Parts of the Brain|"Is the computerized measurement of amyloid content in different parts of the brain.~The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.~The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.~The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements."|PET scans performed on patients 90 minutes post Flutemetmol Administration|The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.||Standard Uptake Value Ratio ( SUVR)||Standard Deviation|Mean
54805|NCT01265394|Primary|Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid|"The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.~The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading)."|PET scans performed on patients 90 minutes post Flutemetmol Administration|Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative||Brain Scans Read|||Number
54806|NCT01265056|Secondary|To Determine the Impact of Psychological Functioning in Patients Following Admission for Their Burn Injury. This Will be Determined by Review of Two Forms (the Brief Symptom Inventory and the Sickness Impact Profile).||From time of enrollment to 2 weeks after being discharge||||||
54807|NCT01265056|Secondary|To Determine the Trends in Several Associated Clinical Effects of Opioid Administration Between the Treatment and the Control Groups. These Effects Include: 1. Fluid Resusitation 2. Insulin Resistance 3. Hospital Associated Infections||From time of enrollment to 2 weeks after being discharge||||||
54808|NCT01265056|Primary|To Determine the Trends in Opioid Consumption Between the Treatment and the Control Groups.||From time of enrollment to 2 weeks after being discharged|This was an intention to treate analysis. We measured the oral morphine equivalents both groups were administered.||mg||Standard Deviation|Mean
54809|NCT01264952|Primary|Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)||After operation on day 7|||Toxicity, symptoms|||Number
54810|NCT01264952|Secondary|Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology||After operation or 1st day after operation, 7th day, 30th day, monthly|||complete response (CR)|Participants||Number
54811|NCT01264952|Secondary|Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment)||After operation on tha days 2, 7, 30, monthly|||patients with non-severe adverse events|||Number
54812|NCT01264939|Primary|Percentage of Participants With Adverse Events|The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.|Baseline to the end of study (up to 40 weeks)|Safety population: All randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
54813|NCT01264939|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12. The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
54814|NCT01264939|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded “No” to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.||Percentage of days||Standard Deviation|Mean
54815|NCT01264939|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug and who had a DLQI score at Week 12.||Units on a scale||Standard Deviation|Mean
54816|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
54817|NCT01264939|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
54830|NCT01264887|Primary|Severity of Adverse Events|"The severity of treatment emergent adverse events was any untoward medical occurrence in a patient administered tapentadol. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the (investigational) medicinal product whether or not related to the use of tapentadol.~The clinical “intensity” of adverse event were classified as:~Mild: signs and symptoms which can be easily tolerated. Symptoms could be ignored and disappeared when the participant is distracted.~Moderate: symptoms caused discomfort but were tolerable, they could not be ignored and affect concentration.~Severe: symptoms affected the usual daily activity."|Day 1; up to 144 weeks|Safety Set.||participants|||Number
54818|NCT01264939|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Percentage of participants|||Number
54819|NCT01264939|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Only patients with a MID response were included in the analysis.||Weeks||95% Confidence Interval|Median
54820|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
54821|NCT01264939|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
54822|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.||Units on a scale||Standard Deviation|Mean
54823|NCT01264887|Primary|Time Dependence of Adverse Events|The onset and duration of TEAEs was not evaluated for this trial.|Day 1; 144 weeks||||||
54824|NCT01264887|Secondary|Tapentadol Prolonged Release Exposure|The number of days that participants took tapentadol prolonged release. The extent of exposure was categorized into 2 periods, less than 90 days and more than 90 days (up to 144 weeks).|Day 1; up to 144 weeks|Safety Set.||participants|||Number
54825|NCT01264887|Other Pre-specified|Average Daily Total Tapentadol Prolonged Release Dose|The Total Daily Dose (TDD) on any given day is the sum of the morning and evening intake amounts. The average TDD is an individuals average over the trial period.|Day 1; up to 144 weeks|Safety Set.||mg per day||Standard Deviation|Mean
54826|NCT01264887|Other Pre-specified|Average Pain Intensity (Over a Twelve-week Period)|"The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.~Average pain intensity score is the average of pain experienced for previous 24 hours as rated on an 11-point NRS at each visit. Calculations are based on 3 consecutive planned (at 4-weekly intervals) visits.~All available data of a participant was used; if a participant dropped-out or had incomplete data during a 12-week period no imputations were performed for the missing values."|Day 1; up to Week 144|Safety Set.||units on a scale||Standard Deviation|Mean
54827|NCT01264887|Primary|Countermeasures Taken Due to Treatment Emergent Adverse Events|Participant-based analysis of treatment emergent adverse events (TEAEs) regarding countermeasure to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The countermeasure taken by the investigator were reported.|Day 1; up to 144 weeks|Safety Set.||participants|||Number
54828|NCT01264887|Primary|Relatedness Assessment of Treatment Emergent Adverse Events|Participant-based analysis of treatment emergent adverse events (TEAEs) regarding the relationship to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The relationship was rated by the investigator. The categorization of relatedness into one of the two categories was based on the following: Related included “possible”, “probable/likely”, and “certain”; whilst unrelated treatment emergent adverse events include those rated by the investigator as “unlikely”, “conditional/unclassified”, “un-assessable/unclassifiable”, and “not related”.|Day 1; up to 144 weeks|Safety Set.||participants|||Number
54829|NCT01264887|Secondary|Assess Consumption of Tapentadol During Long Term Use|Summary of the modal total daily dose during the treatment period. The modal dose was based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.|Day 1; up to 144 weeks|"The modal dose is based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.~No participant received more than 500 mg per day."||participants|||Number
54831|NCT01264835|Primary|Procedure Duration (Surgery Time)|Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.|Time of surgery|No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.||minutes||Standard Deviation|Mean
54832|NCT01264770|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
54833|NCT01264770|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
54834|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
54835|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Units on a scale||Standard Deviation|Mean
54836|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Percentage improvement from baseline||Standard Deviation|Mean
54888|NCT01263717|Secondary|HbA1c|Hemoglobin A1c.|6 months|All available data were used; data were not available for one subject.||Change in %||95% Confidence Interval|Mean
54944|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54837|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 6|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Percentage improvement from baseline||Standard Deviation|Mean
54838|NCT01264770|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
54839|NCT01264770|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
54840|NCT01264770|Secondary|Proportion of Patients Achieving ACR20 up to Week 24|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
54841|NCT01264770|Secondary|DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Percentage of responders|||Number
54842|NCT01264770|Secondary|DAS28 EULAR Response at Week 6|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Percentage of responders|||Number
54843|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.||Units on a scale||Standard Deviation|Mean
54889|NCT01263717|Secondary|Insulin Sensitivity|In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.|6 months|All available data were used; data were not available for some subjects.||Change in mg/kg/min||95% Confidence Interval|Mean
54844|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.||Units on a scale||Standard Deviation|Mean
54845|NCT01264614|Primary|Neurophysiological Function Pre- & Post- Intervention|Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention|Baseline and 3 months||||||
54846|NCT01264614|Primary|Figure Copy & Delayed Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy & Delayed possible score range is 0-36 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Points||Standard Deviation|Mean
54847|NCT01264614|Primary|Fuld Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Points||Standard Deviation|Mean
54848|NCT01264614|Primary|Color Trails Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Time to complete (seconds)||Standard Deviation|Mean
54849|NCT01264614|Primary|Digits Backwards Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Points||Standard Deviation|Mean
54850|NCT01264614|Primary|Stroop Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.||Time to complete (seconds)||Standard Deviation|Mean
54851|NCT01264380|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until death (Up to Week 124)|Data for OS was not collected as there was a change in planned analysis, not to collect the data.|||||
54852|NCT01264380|Secondary|Percentage of Participants With Best Objective Response (BOR) as Complete Response (CR) or Partial Response (PR)|BOR was defined as the best objective response assessed by investigator during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR was the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation. It is defined as the number of participants whose best objective response was complete response (CR) or partial response (PR) divided by the total number of efficacy evaluable participants. CR: disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) were non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until disease progression or death (Up to Week 124)|Intent-to-treat (ITT) population included participants with measurable disease who received at least 1 dose of vemurafenib. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
54853|NCT01264380|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel) in the Fasted and Fed States|Apparent first-order terminal elimination rate constant (kel), was calculated as the negative slope of the linear regression of the terminal phase in plasma vemurafenib concentration-time profile using specific appropriate time points. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|"PK analysis population. Here number of participants analyzed=participants who were evaluable for this outcome measure."||1/h||Standard Deviation|Mean
61768|NCT01191190|Secondary|IwCLL-WG Defined Progressive Disease (PD)|Responses were assessed two months after completion of therapy|2 months|||participants|||Number
54854|NCT01264380|Primary|Terminal Elimination Half-Life (t1/2) in the Fasted and Fed States|T1/2 is the time required for the concentration of the drug to reach half of its original value. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||hour||Standard Deviation|Mean
54855|NCT01264380|Primary|Time to Reach Maximal Plasma Concentration (Tmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.||hour||Full Range|Median
54856|NCT01264380|Primary|Minimum Observed (Trough) Plasma Concentration (Cmin) in the Fasted and Fed States|Single dose Pre-dose concentration is referred as Cmin here. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Pre-dose on Periods A and B|PK analysis population.||µg/mL||Standard Deviation|Mean
54857|NCT01264380|Primary|Maximal Observed Plasma Concentration (Cmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.||µg/mL||Standard Deviation|Mean
54858|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Sample With Last Measurable Concentration (AUC[0-last]) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||µg*h/mL||Standard Deviation|Mean
54859|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0-inf]) in the Fasted and Fed States|Pharmacokinetic (PK) analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 hours (h) post-dose (pd) on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population included participants who received both single doses of vemurafenib in Periods A and B without protocol violation and provided adequate PK assessments to calculate important PK parameters. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.||micrograms*hour per milliliter (µg*h/mL)||Standard Deviation|Mean
54860|NCT01264081|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|3 years|Three study participants were affected by the adverse events: 2 - who completed the study and 1 who did not complete cycle 1 due to death of progressive disease. The participant who withdrew from study didn't take Lapatinib and experience any adverse events.||participants|||Number
54861|NCT01264081|Primary|Number of Participants With a Partial Response (PR) and Complete Response (CR) to Lapatinib Who Have Metastatic Melanoma Harboring ERBB4 Mutations.|The number of participants with a partial response and complete response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.|3 years|Only two participants could be evaluated for response and they had SD (none with a PR or CR). Other participants did not reach the evaluation point (i.e. discontinued Lapatinib)as per study protocol, therefore not evaluable.||participants|||Number
54862|NCT01264016|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing five tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|Per protocol||participants|||Number
54863|NCT01264016|Primary|Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject's hematocrit measurement was missing, so this subject's blood test data was not evaluable. Since study staff tested each subject's venous blood using 2 lots of test strips, 2x93(or 186) test results were possible.||percentage of venous bg results|Participants||Number
54890|NCT01263717|Secondary|Endogenous Growth Hormone Secretion|Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.|6 months|All available data were used; data were not available for some subjects.||Change in ng/mL||Inter-Quartile Range|Median
54945|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54864|NCT01264016|Primary|Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject did not complete capillary blood testing (low blood sugar) and one subject hematocrit measurement was missing. These subjects' blood test data was not evaluable. Since the remaining 92 subjects tested 2 test strip lots on the BGM system, 2x92(184) tests results were possible.||percentage of BG Results|Participants||Number
54865|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).~Negative changes show a decrease from Baseline."|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
54866|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).~Negative changes show a decrease from Baseline."|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
54867|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54868|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54869|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54870|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54871|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54872|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
55630|NCT01257750|Primary|Ocular Adverse Events|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing through week 12|12 Weeks of follow-up|All enrolled patients were analyzed.||participants|||Number
54873|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54874|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54875|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54876|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54877|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54878|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).||meter/meter||Standard Deviation|Mean
54879|NCT01263873|Primary|Ease of Intubation, as Measured by an Ease of ETT Insertion Score.|To measure the ease of intubation, an ease of ETT insertion score was obtained by using a 100 millimeter visual analog scale done by the anesthesia provider doing the intubation. The score of 0 millimeters was the easiest intubation and a score of 100 millimeters was the hardest intubation done by that anesthesia provider.|Participants were followed for the duration of intubation, an average of 10 minutes|||Visual Analog Score in millimeters||Standard Deviation|Mean
54880|NCT01263873|Primary|Ease of Intubation, as Measured by Number of ETT Redirections|To measure the ease of intubation, once the airway structure was visualized with the GlideScope, the number of ETT redirections at the glottis to intubate the trachea was counted by video recordings by the PI.|Participants were followed for the duration of intubation, an average of 10 minutes|||Number of redirections to place ETT||Standard Deviation|Mean
54881|NCT01263873|Primary|Ease of Intubation, as Measured by Time in Seconds for ETT Insertion|To measure the ease of intubation by time in seconds for ETT insertion. Time was measured in seconds and started when the anesthesia provider asked for the ETT and stopped once the ETT was placed through the glottis. The time was obtained from video recordings during the intubation by the principal investigator (PI).|Participants were followed for the duration of intubation, an average of 10 minutes|||Seconds||Standard Deviation|Mean
54882|NCT01263717|Secondary|Hemostatic Markers|Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.|6 months||||||
54883|NCT01263717|Secondary|Adiponectin|adiponectin.|6 months|All available data were used. Data were not available for 1 subject.||Change in ng/mL||Inter-Quartile Range|Median
54884|NCT01263717|Secondary|Glucose Tolerance|Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.|6 months|All available data were used; data were not available for some subjects.||Change in 2-hour glucose, mg/dL||95% Confidence Interval|Mean
54885|NCT01263717|Secondary|Carotid Intimal Medial Thickness (cIMT)|Carotid Intimal Medial Thickness (cIMT).|6 months|All available data were used.||Change in mm||95% Confidence Interval|Mean
54886|NCT01263717|Secondary|Lipid Panel|Fasting lipids. Triglyceride value is given.|6 months|All available data were used; data were not available for one subject.||Change in triglyceride, mg/dL||Inter-Quartile Range|Median
54887|NCT01263717|Secondary|Insulin Like Growth Factor 1 (IGF-I)|Insulin Like Growth Factor 1 (IGF-I).|6 months|All available data were used; data were not available for one subject.||Change in ng/mL||Standard Deviation|Mean
54891|NCT01263717|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.||Change in ratio of IMCL/Cr||Inter-Quartile Range|Median
54892|NCT01263717|Primary|Visceral Adipose Tissue|Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.|6 months|Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.||change in cm^2 after 6 months||95% Confidence Interval|Mean
54893|NCT01263717|Primary|Liver Fat|Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.||Change in hepatic lipid-to-water %||Inter-Quartile Range|Median
54894|NCT01263691|Secondary|TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).||geometric mean titer||95% Confidence Interval|Geometric Mean
54895|NCT01263691|Secondary|Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).||days||Full Range|Median
54896|NCT01263691|Primary|Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.~Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56|||percentage of participants|||Number
54897|NCT01263691|Primary|Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.~Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56|||participants|||Number
54898|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||percentage of participants|||Number
54919|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
54920|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
54899|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||participants|||Number
54900|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||percentage of participants|||Number
54901|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.”~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 – 101.5°F~Grade 2: 101.6 – 102.9°F ;~Grade 3: 103.0 – 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||Participants|||Number
54902|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||Percentage of Participants|||Number
54903|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20|||Participants|||Number
54904|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||Percentage of Participants|||Number
54921|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
58569|NCT01225835|Secondary|Average Follicle Diameter at hCG Administration||approximately day 10|The per-protocol (PP) set of participants with non-missing values.||mm||Standard Deviation|Mean
54905|NCT01263691|Secondary|Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).||geometric mean titer||95% Confidence Interval|Geometric Mean
54906|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.”~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6|||Participants|||Number
54907|NCT01263665|Primary|Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure||30 Days post-procedure|||participants|||Number
54908|NCT01263665|Primary|Successful Completion of the Assigned Treatment|Successful completion of the assigned treatment and postdeployment > stent length (of the first deployed 25 cm GORE > VIABAHN Endoprosthesis with PROPATEN Bioactive Surface) > being within 10% of pre-deployment stent length.|Evaluated immediately after the index procedure|||percentage of subjects|||Number
54909|NCT01263639|Primary|"Patient Satisfaction as Measured by Giving an Excellent Score on a 5-point Rating"|Within 2 weeks of discharge from the hospital, but before the patient’s first clinic visit, each group will be called by the Professional Resource Group as part of regular quality improvement by the Vanderbilt Medical Center Department of Strategic Development. The patients will be asked a series of questions aimed at determining overall patient satisfaction based on interactions with the attending orthopaedic trauma surgeon.|within 2 weeks of discharge and before first clinic appointment|||participants|||Number
54910|NCT01263561|Secondary|Complications|Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.|1 year post surgery|||participants|||Number
54911|NCT01263561|Primary|Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication||1 year post surgery|||percentage of participants|||Number
54912|NCT01263561|Primary|Intraocular Pressure||1 year post surgery|||mmHg||Standard Deviation|Mean
54913|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
54914|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
54915|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
54916|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||pg•hr/mL||Standard Deviation|Mean
54917|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
54918|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||ng•hr/mL||Standard Deviation|Mean
59098|NCT01218100|Secondary|The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)|||mm HG||Standard Deviation|Mean
54922|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
54923|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
54924|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||μU•hr/mL||Standard Deviation|Mean
54925|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
54926|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
54927|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
54928|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg•hr/dL||Standard Deviation|Mean
54929|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54930|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54931|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54932|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54933|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54934|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54935|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54936|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54937|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54938|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54939|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54946|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54947|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54948|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54949|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54950|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54951|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54952|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54953|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54954|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54955|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54956|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54957|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54958|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54959|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54960|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54961|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54962|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54963|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54964|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54965|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54966|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54967|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54968|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54969|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54970|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54971|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
54972|NCT01263509|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set||participants|||Number
54973|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
54974|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
54975|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
54976|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.||pg·hr/mL||Standard Deviation|Mean
54977|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
54978|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
54979|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
54980|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.||μU·hr/mL||Standard Deviation|Mean
54981|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
56045|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
54982|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
54983|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
54984|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||ng·hr/mL||Standard Deviation|Mean
54985|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
54986|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
54987|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
54988|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg·hr/dL||Standard Deviation|Mean
54989|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54990|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54991|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54992|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
54993|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54994|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54995|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54996|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54997|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54998|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
54999|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
55000|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
55001|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
55002|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
55003|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
55004|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||ng/mL||Standard Deviation|Mean
55005|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55006|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55007|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55008|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55009|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55010|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55011|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55012|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55013|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55014|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55015|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55016|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12|Values are Summary Statistics.||mg/dL||Standard Deviation|Mean
55017|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55018|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55019|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55020|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55021|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
56205|NCT01251952|Secondary|To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.||days 0 and 21 post autologous stem cell transplantation||||||
55022|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55023|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55024|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55025|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55026|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55027|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55028|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55029|NCT01263496|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date – last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set||participants|||Number
55030|NCT01263483|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.||pg·hr/mL||Standard Deviation|Mean
55031|NCT01263483|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||ng·hr/mL||Standard Deviation|Mean
55032|NCT01263483|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.||μU·hr/mL||Standard Deviation|Mean
55033|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg·hr/dL||Standard Deviation|Mean
55034|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55035|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55036|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55599|NCT01256983|Primary|Bedtime|"The mean bedtime assessed by actimetry of each 3 week period (day 21, 42, 63 ) was used as outcome to be compared with the control group.~Bedtime is expressed in time (hours and minutes)"|Mean Bedtimes over 21 days for each period|||Hours||Standard Deviation|Mean
55037|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55038|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55039|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55040|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55041|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55042|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55043|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55044|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55045|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55046|NCT01263483|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55047|NCT01263470|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||pg·hr/mL||Standard Deviation|Mean
55048|NCT01263470|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng·hr/mL||Standard Deviation|Mean
55062|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55049|NCT01263470|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||μU·hr/mL||Standard Deviation|Mean
55050|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg·hr/dL||Standard Deviation|Mean
55051|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55052|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55053|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55054|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55055|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||ng/mL||Standard Deviation|Mean
55056|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55057|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55058|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55059|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||mg/dL||Standard Deviation|Mean
55060|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55061|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
59099|NCT01218100|Primary|The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)|||mm HG||Standard Deviation|Mean
55063|NCT01263470|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
55064|NCT01263444|Secondary|Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.|Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||percentage of participants|||Number
55065|NCT01263444|Secondary|Mean Change From Baseline in IOP at Week 4|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 4|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||mmHg||Standard Deviation|Mean
55066|NCT01263444|Secondary|Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||mmHg||Standard Deviation|Mean
55067|NCT01263444|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.||mmHg||Standard Deviation|Mean
55068|NCT01263301|Primary|no Change of Vertebral Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|2 years|as above explained||participants|||Number
55069|NCT01263301|Primary|Change of Vertebral Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|two year|determined as above explained||participants|||Number
55070|NCT01263301|Primary|no Change of Subclavian Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|one year|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.||participants|||Number
55071|NCT01263301|Primary|Change of Subclavian Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|two years|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.||participants|||Number
55072|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 6 (Week 4)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
55073|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 5 (Week 3)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 5 (Week 3)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
55252|NCT01261325|Secondary|Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||percentage of subjects|||Number
55074|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 4 (Week 2)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 4 (Week 2)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
55075|NCT01263132|Secondary|Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire|SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.|Visit 2 (Baseline) to Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. Two participants in the MF0434 + Gabapentin group had missing values and hence are not included.||Units on a Scale||Standard Deviation|Mean
55076|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 3 (Week 1)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 3 (Week 1)|Per Protocol (PP) population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study Intention to treat (ITT) and PP populations were the same.||Units on a Scale||Standard Deviation|Mean
55077|NCT01263054|Secondary|Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit|"ODI - score range = 0 - 100. 0 corresponds to no disability and 100 indicates the maximum disability possible. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 Months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
55078|NCT01263054|Secondary|Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit|"PGIC - score range = 1 - 7. 1 corresponds to very much improved and 7 indicates very much worse pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Six subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Error|Mean
55079|NCT01263054|Secondary|Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit|"BDI - score range = 0 - 63. 0 corresponds to minimal depression and 63 indicates severe depression. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and eight subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
55080|NCT01263054|Secondary|Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit|"EQ-5d VAS - score range = 0 - 100. 0 corresponds to the worst imaginable health state and 100 indicates the best imaginable health state. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
55081|NCT01263054|Secondary|Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit|"Short Form 36-PF - score range = 0 - 100. 0 corresponds to greatest disability and 100 indicates no disability. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
55082|NCT01263054|Secondary|Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|||percentage of study group|||Number
55083|NCT01263054|Primary|Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and six subjects in the Medical Management study arm did not provide follow-up data.||units on a scale||Standard Deviation|Mean
55084|NCT01263028|Secondary|Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders||24 Weeks||||||
55085|NCT01263028|Secondary|Change in Iron Supplementation||24 Weeks||||||
55086|NCT01263028|Secondary|Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels||24 Weeks||||||
55087|NCT01263028|Secondary|Change in Inflammatory Markers||24 Weeks||||||
55088|NCT01263028|Primary|Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements||24 Weeks||||||
55105|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55089|NCT01263015|Secondary|Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48|"The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, “I do not have this symptom”; 1, It doesn’t bother me”; 2, “It bothers me a little”; 3, “It bothers me”; 4, It bothers me a lot. Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS."|Baseline and Week 4 through 48|ITT-E Population. Participants with missing bother item scores at Week 4 had their last observation carried forward (LOCF). Only those participants contributing to the model (i.e., without missing response variables after LOCF or covariates) were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
55090|NCT01263015|Secondary|Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144|Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG.|Through Week 144|PDVF Genotypic Population: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF||Participants|||Number
55091|NCT01263015|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death.|From Baseline until Week 144|Safety Population: all participants who received at least one dose of investigational product||Participants|||Number
55092|NCT01263015|Secondary|Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline until Week 144|ITT-E Population||Participants|||Number
55093|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
55094|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Week 144|Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured.|Baseline and Week 144|ITT-E Population||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Least Squares Mean
55095|NCT01263015|Secondary|Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144|Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population||log10 copies/mL||Standard Deviation|Mean
55600|NCT01256944|Primary|Impaired Glucose Tolerance|Impaired glucose tolerance was defined as two hour glucose levels of 7.8–11.1 mmol/L in the 75 g oral glucose tolerance test. In women with impaired glucose tolerance, the fasting plasma glucose level should be <7 mmol/L.|1 years|||percentage of participants|||Number
55096|NCT01263015|Secondary|Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24|Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population||Participants|||Number
55097|NCT01263015|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 96 and Week 144|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
55098|NCT01263015|Secondary|Time to Viral Suppression (<50 c/mL)|Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population||Days||95% Confidence Interval|Median
55099|NCT01263015|Primary|Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
55100|NCT01262989|Primary|Cmax|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study||ng/ml||Standard Deviation|Mean
55101|NCT01262989|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study||ng/h/ml||Standard Deviation|Mean
55102|NCT01262989|Primary|AUC0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study||ng per hour per ml (ng/h/ml)||Standard Deviation|Mean
55103|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. No analysis was performed regarding the acquisition of new H. influenzae strains in the nasopharynx.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2050||||
55104|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. No analysis was performed regarding the acquisition of new H. influenzae strains in the nasopharynx.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2050||||
55106|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55107|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55108|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55109|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55110|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55111|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55112|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55113|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55114|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55115|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55116|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55117|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
58039|NCT01230021|Secondary|Vital Signs - Pulse||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||beats/minute||Standard Deviation|Mean
55118|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55119|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55120|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55121|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55122|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55123|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55124|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55125|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55133|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55126|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55127|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55128|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55129|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55130|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55131|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55132|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55134|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55135|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55136|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
55137|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
55138|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55139|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55140|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
55141|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
55142|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55143|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55144|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
55145|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
55146|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
55147|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
55148|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2050||||
55149|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||12/2050||||
55150|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2050||||
55151|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||12/2050||||
55152|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2017||||
55153|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||12/2017||||
55154|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55155|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55174|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)||12/2050||||
55601|NCT01256944|Primary|LDL|"Lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and sex hormone binding globulin (SHBG).~Abnormal LDL was ≧4.14mmol/L."|1 year|||mmol/L||Standard Deviation|Mean
55156|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55157|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55158|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2050||||
55159|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||12/2050||||
55160|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||12/2017||||
55161|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||12/2017||||
55162|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55163|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55164|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55194|NCT01262599|Primary|Pain Score Measured by Visual Analog Scale|We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.|12 hours|||units on a scale||Standard Deviation|Mean
55195|NCT01262573|Secondary|Dyspareunia|Assessed preoperatively and up to 3 months postop|Postoperative|||participants|||Number
55165|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55166|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
55167|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
55168|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).~Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule."|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
55169|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).~Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule."|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
55170|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 1/Step 1 Subjects|Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55171|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)||12/2050||||
55172|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55173|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
55175|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55176|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
55177|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 1/Step 1 Subjects|Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||LU/mL||95% Confidence Interval|Geometric Mean
55178|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 1/Step 1 Subjects|"Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL).~Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1."|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||LU/mL||95% Confidence Interval|Geometric Mean
55179|NCT01262872|Secondary|Number of Subjects With Serious Adverse Events (SAEs) – For Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55180|NCT01262872|Secondary|Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges – For Cohort 1/Step 1 Subjects|Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55181|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55182|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55196|NCT01262573|Primary|Vaginal Cuff Closure Time|Average time (measured in minutes)|During the surgical procedure|||minutes||Standard Deviation|Mean
55197|NCT01262547|Secondary|Incidence of Adverse Effects, Including Increased Activity of Vitiligo||24 weeks|||participants reporting redness|||Number
58063|NCT01229891|Secondary|Fasting Serum Glucose (FSG)||12-week|||mg/dL||Standard Deviation|Mean
58064|NCT01229891|Primary|Serum 25-hydroxyvitamin D||12-week|||nmol/L||Standard Deviation|Mean
55183|NCT01262872|Primary|Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55184|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55185|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination – For Step 1/Cohort 1 Subjects|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55186|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination – For Step 1/Cohort 1 Subjects|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
55187|NCT01262820|Secondary|Overall Survival|Overall survival is defined as the time of enrollment until death|Eight (8) months w additional time for response date to mature|||weeks||95% Confidence Interval|Median
55188|NCT01262820|Secondary|Progression Free Survival|Progression free survival is defined as time of enrollment until disease progression or death|Eight (8) months w additional time for response date to mature|||weeks||95% Confidence Interval|Median
55189|NCT01262820|Secondary|Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1|estimate of combined response rate (Complete Response (CR) + Partial Response (PR) per RECIST v1.1|8 months with additional time for response to mature|||participants|||Number
55190|NCT01262820|Primary|Disease Control Rate|CR + PR + SD lasting equal to or greater than 12 weeks as defined by RECIST v1.1 in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab|Eight (8) months w additional time for response date to mature|||percent||95% Confidence Interval|Number
55191|NCT01262755|Primary|Epidemiologic Factors Associated With Prevalent Reflux Disease.|Patients will complete a series of standardized questionnaires to determine the prevalence of reflux disease and risk factors for its development. We will query diet, depression, drug, tobacco, and alcohol use as well as a variety of other factors. We will study 450 African Americans living in North Philadelphia.|Two years|Patients successfully identified from targeted area.||percentage of participants with GERD||95% Confidence Interval|Number
55192|NCT01262599|Secondary|Levels of Cytokines|Concentration of the cytokines IL1-beta in the wound bed. Exudates will be collected from standard Jackson-Pratt #10 drains until the patient is discharged. IL1-beta is an early central proinflammatory cytokine that induces cyclooxygenase, an enzyme responsible for prostaglandin synthesis. A decrease in IL1-beta correlates with a decrease in pain. Cytokines and growth factors may contribute to more rapid post-op pain reduction and healing.|4 days||||||
55193|NCT01262599|Secondary|Amount of Narcotic Pain Medications|We will record the amount of pain medication used at twelve hour intervals for the duration of the hospital stay. Pain medications will be converted to oxycodone/acetaminophen equivalents for statistical analysis|4 days||||||
55198|NCT01262547|Primary|Change in Target VASI Score From Baseline to Week 24.|Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).|24 weeks|||units on a scale||Full Range|Mean
59237|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|14 weeks||||||
55199|NCT01261507|Secondary|False Positive Decisions of Radiologists|This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level.|1 day|||percentage of marks not on cancers||Standard Error|Mean
55200|NCT01261507|Secondary|Sensitivity and Specificity|Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected.|1 day|||Percentage of cases||Standard Error|Mean
55201|NCT01261507|Primary|Localized Receiver Operating Characteristic (LROC) Comparison|"The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as noise cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement."|1 day|All participants were included for calculation of A-LROC and Sensitivity-Specificity. All radiographs were interpreted both without and with software assistance||unitless|Participants|Standard Error|Mean
55202|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) during open-label treatment period||participants|||Number
55203|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)||participants|||Number
55204|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) for open label-treatment period||participants|||Number
55205|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|From Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)||participants|||Number
55206|NCT01262456|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
55207|NCT01262456|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
55208|NCT01262456|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||minutes||Standard Deviation|Mean
55220|NCT01262131|Primary|Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.|"Minimum scale value is '0' which represents 'no pain at all' and is the best outcome.~Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome."|2 weeks (baseline to end of treatment)|Analysis was by intention to treat which included all enrolled subjects in this case to study completion.||Scores on a scale||Standard Deviation|Mean
55272|NCT01260883|Primary|Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants|population-based analysis of ketorolac stereo-isomers|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo. Drug handling not different at doses of 0.5 or 1 mg/kg so reported together.||ml||Standard Error|Mean
55209|NCT01262456|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.||probability|||Number
55210|NCT01262456|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||nocturnal voids||Standard Deviation|Mean
55211|NCT01262456|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).||probability|||Number
55212|NCT01262456|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).||nocturnal voids||Standard Deviation|Mean
55213|NCT01262352|Secondary|Change From Baseline in CF Questionnaire-Revised (CFQ-R) Score (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID). The primary analytical focus was the respiratory health domain, which was analyzed by combining all self-response questionnaire versions from different age groups (e.g., Adult/Adolescent and Child versions).|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||score on a scale||Standard Error|Least Squares Mean
55214|NCT01262352|Secondary|Change From Baseline in Sweat Chloride|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||millimoles per liter||Standard Error|Least Squares Mean
55215|NCT01262352|Secondary|Absolute Change From Baseline in Percent Predicted FEV1|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||percent||Standard Error|Least Squares Mean
55216|NCT01262352|Primary|Absolute Change From Baseline in Lung Clearance Index (LCI)|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal SF6 concentration to 1/40th of the starting value.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.||ratio||Standard Error|Least Squares Mean
55217|NCT01262339|Primary|Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.||26 weeks|Study was closed prematurely as principal investigator left the University of Wisconsin. Insufficient data for outcome measures analysis. Data was not entered into tabular format. Study closed and records archived.|||||
55218|NCT01262287|Secondary|Change in Standard Drinks Per Week - Moderation by Genetic Variation|Moderation of primary outcome measure by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder)|8-week treatment|||standard drinks per week||Standard Error|Mean
55219|NCT01262287|Primary|Change Number of Standard Drinks Per Week.|Change in Average Standard Drinks (14 gr ethanol) per week for last 2 weeks of treatment (wk 7-8) vs. baseline time life follow-back 90 day history|8-week treatment period|||standard drinks per week||Standard Error|Mean
59238|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|8 weeks||||||
55221|NCT01262118|Secondary|Cholesterol Efflux Rate|Cholesterol efflux rate was measured using isotope dilution method in which rate of appearance of isotope 13C-free cholesterol in plasma representing whole body efflux from tissues was assessed. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg/kg)/hr||Standard Deviation|Mean
55222|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate|Fractional catabolic rate for HDL-apoA1 were calculated using the 13C isotopic enrichment of VLDL as the limiting value. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||%/hr||Standard Deviation|Mean
55223|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate|HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg/kg/hr||Standard Deviation|Mean
55224|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate|Fractional catabolic rate for LDL ApoB were calculated using the 13 carbon (13C) isotopic enrichment of very low density lipoprotein (VLDL) as the limiting value. Isotope 13C in plasma was measured using Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS).|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||%/hr||Standard Deviation|Mean
55225|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate|LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg/kg)/hr||Standard Deviation|Mean
55226|NCT01262118|Secondary|Cholesterol Ester Fractional Catabolic Rate|Cholesterol ester fractional catabolic rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. Fractional catabolic rate was the percentage of cholesterol ester which was replaced, transferred or lost per unit of time.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage ester per hour (%/hr)||Standard Deviation|Mean
55227|NCT01262118|Secondary|Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration|Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.||mg/dL||Standard Deviation|Mean
55228|NCT01262118|Primary|Cholesterol Ester Production Rate at Week 6|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg/kg)/hr||Standard Deviation|Mean
55229|NCT01262118|Primary|Cholesterol Ester Production Rate at Baseline|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||(mg per kilogram) per hour ([mg/kg]/hr)||Standard Deviation|Mean
55230|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6|Blood level of HDL-C was measured following a 12-hours fasting.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.||mg/dL||Standard Deviation|Mean
55231|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline|Blood level of HDL-C was measured following a 12-hours fasting.|Baseline|Full analysis set (FAS) included all enrolled participants who had any measurement of cholesterol ester production rate available.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
55232|NCT01262105|Primary|Surgery Site CFU Density|CFU culture counts for samples taken in surgery.|Ten-minute intervals throughout procedure|||CFU/m3||95% Confidence Interval|Mean
55233|NCT01262092|Primary|Illicit Opioid Use as Determine by Urine Dipsticks|urine data are from those obtained during the buprenorphine taper|3x weekly during wks 3 and 4|Those who started the bup detox (N=24) excluding 1 subjects' data in the gabapentin group due to evidence of noncompliance with medication procedures and diversion (N=1).||% of urines positive for opioids|Participants|Standard Error|Mean
55234|NCT01262027|Secondary|Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)|Safety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section.|6 months|Evaluation included all participants.||percentage of participants|||Number
55250|NCT01261325|Secondary|Time to the First Type I Seizure During the Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||days||95% Confidence Interval|Median
55251|NCT01261325|Secondary|All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||number of seizures/ 28-day||Inter-Quartile Range|Median
58288|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Threshold|RV pacing threshold results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant.||volts (V)||Standard Deviation|Mean
55235|NCT01262027|Primary|Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants|Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid|6 months|Three participants were not evaluable for response due to early departure from study.||participants|||Number
55236|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism presented in dioptres at each visit.|Visits 4-8|Surgically Induced Astigmatism—FAS Population||Dioptres|Participants|Standard Deviation|Mean
55237|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism was presented in dioptres at each visit.|Visits 1-3|Surgically Induced Astigmatism, FAS Population||Dioptres|Participants|Standard Deviation|Mean
55238|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|visit 5, visit 6, visit 7, visit 8|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
55239|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|Visit 1, visit 2, visit 3, visit 4|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
55240|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.|visit 5, visit 6, visit 7, visit 8|Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
55241|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity|Visit 1, visit 2, visit 3, visit 4|Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population||logMAR|Participants|Standard Deviation|Mean
55242|NCT01261975|Primary|Refractive Stability|Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.|12 weeks|Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)— Full analysis Set (FAS) Population||Eyes|Participants||Number
55243|NCT01261624|Secondary|ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12|ACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0- 100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 50, 70, 90 and 100 of response, defined as a 50%, 70%, 90% and 100% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|at week12|||participants|||Number
55244|NCT01261624|Primary|ACR Pediatric Response Level (ACRPRL) 30 After 12 Weeks of Treatment|ACR Pediatric variables include: Physician’s Global Assessment of disease activity on a 0-100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent’s or patient’s Global Assessment of Patient’s overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 30 of response, defined as a 30% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|12 weeks of treatment|||participants|||Number
55245|NCT01261559|Primary|Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)|Relative skin entrance dose at the breast (group mean of patient's average skin entrance dose at TLDs 2-4) divided by skin entrance dose at the inframammary TLD (TLD 1) in %. For each patient, doses at TLDs 2-4 were averaged, and then the group mean of this was divided by the group mean at the inframammary TLD, then multiplied by 100 to get % dose. A relative dose of 20% means that the skin entrance dose at the breast was 20% of the skin entrance dose at the inframammary fold.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour|||percentage of dose||Standard Deviation|Mean
55246|NCT01261559|Secondary|CT Image Noise and Image Quality|CT images acquired will be reviewed for the presence of artifacts and interrogated for image noise|two months||||||
55247|NCT01261559|Primary|Skin Entrance Radiation Dose During Computed Tomography (CT)|Skin entrance radiation doses will be measured with Thermoluminescent dosimeters (TLDs) affixed to the subject's chest and breast during CT of the abdomen. TLD #1 is at the inframammary fold, serving as internal control for each subject. Three additional TLDs (#2-4) are affixed to the subject's breast at 3 pre-ascribed locations. The same is done for the right and left breasts (8 TLDs total). TLDs will then be submitted to Landaeur for measurement.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour|||mrad||Standard Deviation|Mean
55248|NCT01261325|Secondary|Time to the Tenth Type I Seizure During the Treatment Period||12 week Treatment Period|||days||95% Confidence Interval|Median
55249|NCT01261325|Secondary|Time to the Fifth Type I Seizure During the Treatment Period||12 week Treatment Period|||days||95% Confidence Interval|Median
55253|NCT01261325|Secondary|Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||percentage of subjects|||Number
55254|NCT01261325|Secondary|Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||percentage of change||Inter-Quartile Range|Median
55255|NCT01261325|Primary|50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.|Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||Percentage of subjects|||Number
55256|NCT01261325|Primary|Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary endpoint: United States of America (FDA)|12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.||Percentage of reduction|||Number
55257|NCT01261052|Secondary|Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity.|Assessment of control of post prandial hyperglycemia with APD and FMPD/APD interventions using mean post-prandial glucose (3 hours after meals).|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment||mg/dl||Standard Deviation|Mean
55258|NCT01261052|Primary|Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity|The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment||mg/dl||Standard Deviation|Mean
55259|NCT01260948|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
55260|NCT01260948|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
55261|NCT01260922|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
55262|NCT01260922|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
55263|NCT01260896|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
55264|NCT01260896|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
55265|NCT01260896|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
55266|NCT01260896|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
55267|NCT01260896|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
55268|NCT01260896|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
55269|NCT01260883|Secondary|Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants|continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo||per cent time of 12 hours||Standard Deviation|Mean
55270|NCT01260883|Secondary|Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery|total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac and 12 received placebo infusion after surgery||mg/kg||Standard Deviation|Mean
55271|NCT01260883|Primary|Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery|noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants|24 hours after surgery|52 infants of the 77 total were aged 6-18 months. 15 were excluded for abnormal laboratory values at screening or for lack of access to draw blood samples. 25 received drug, 12 placebo.Doses 0.5 or 1 mg/kg reported together since no difference in analysis.||min||Standard Deviation|Mean
55273|NCT01260883|Primary|Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants|population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery|24 hours after surgery|of 52 enrolled infants aged 6-18 months, 37 completed the study. Of these, 25 received drug, 12 placebo.Doses of 0.5 or 1 mg/kg showed no difference in handling so reported together.||ml||Standard Error|Mean
55274|NCT01260883|Primary|Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants|stereo-specific ketorolac clearance by population-based analysis (NONMEM)|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded for abnormal laboratory results or intravenous sampling catheters that did not allow sampling. 25 infants aged 6-18 months received ketorolac, 12 received placebo. Doses of 0.5 or 1 mg/kg reported together since no difference found in handling.||ml/min||Standard Error|Mean
55275|NCT01260883|Secondary|Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants|continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo|12 hours after ketorolac or placebo infusion|25 infants aged 2-6 months enrolled; 11 excluded. 8 received ketorolac, 6 placebo||percentage of time in 12 h after drug||Full Range|Median
55276|NCT01260883|Secondary|Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery|total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo|first day after surgery|25 infants enrolled but 11 excluded. 8 received ketorolac, 6 placebo. total morphine given over 12 hours following infusion collected||mg/kg||Standard Deviation|Mean
55277|NCT01260883|Primary|Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants|half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery|24 hours after surgery|total infants enrolled was 77; 26 were excluded before study procedures began. Of 51 infants completing the study, 8 infants aged 2-6 months received drug.No difference in analysis at doses of 0.5 or 1 mg/kg so reported together.||min||Standard Error|Mean
55278|NCT01260883|Primary|Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM)|24 hours post surgery|25 infants aged 2-6 months enrolled; 11 excluded for no sampling intravenous access. 8 infants received drug, 6 received placebo. No difference in analysis of doses of 0.5 or 1 mg/kg so reported together.||ml||Standard Deviation|Mean
55279|NCT01260883|Primary|Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants|24 hours after surgery|infants enrolled but did not complete protocol if abnormal laboratory studies or intravenous catheters were not functioning prior to study drug infusion. Of 77 enrolled, 51 completed study; of the 33 given ketorolac,8 were aged 2-6 months. Doses of 0.5 or 1 mg/kg were handled similarly so reported together.||ml||Standard Error|Mean
55280|NCT01260883|Primary|Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery|stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)|24 hours following surgery|of 25 infants aged 2-6 months enrolled, 11 were excluded. 8 received drug, 6 received placebo; this is a subset of the 77 enrolled infants (aged 2-18 months) of whom 51 completed the study. Infants receiving drug at 0.5 or 1 mg/kg were reported together, since no difference in drug handling was seen.||ml/min||Standard Error|Mean
55281|NCT01260701|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.|Up to 2 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
55282|NCT01260701|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to < 1.0 cm. Partial response (PR) is >= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 2 years|Eligible patients who began protocol therapy and were assessed for response.||percentage of participants||95% Confidence Interval|Number
55283|NCT01260701|Primary|Overall Survival (OS)|Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who began protocol therapy.||months||95% Confidence Interval|Median
55284|NCT01260701|Secondary|Progression Free Survival (PFS)|PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 2 years|Eligible patients who began protocol therapy||months||95% Confidence Interval|Median
55285|NCT01260688|Secondary|Symptom Assessment Using FACT-P Questionnaire and PPI Scale||Up to 12 weeks||||||
55286|NCT01260688|Secondary|Incidence of Toxicities Graded According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0||Up to 30 days after last dose of study drugs||||||
55305|NCT01260454|Secondary|Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change|We counted the number of participants who used any amount of narcotic during the 14 day diary period.|14 days|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.||participants|||Number
55287|NCT01260688|Primary|12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2)|Compared between the two arms using Z test.|3 months|Based on primary endpoint, 8 patients in Arm II had PFS equal than or greater than 12 weeks as opposed to Arm I where only 2 patients had PFS equal than or greater than 12 weeks.||participants|||Number
55288|NCT01260662|Secondary|Procedural Recall|After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.|Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||percentage report recall of procedure|||Number
55289|NCT01260662|Secondary|Respiratory Depression|Continuous capnographic monitoring|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||number of respiratory depression events|||Number
55290|NCT01260662|Primary|Hypoxia|Pulse oximetry|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||Patients which experienced hypoxia|||Number
55291|NCT01260662|Primary|Clinical Interventions During Sedation|Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm||Clinical interventions performed|||Number
55292|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers||After dose on Day 10 of Active Treatment Periods 1 and 2|1 clopidogrel smoker was not evaluable for this measure.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
55293|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers|Blood samples for determination of plasma concentrations of the prasugrel active metabolite, clopidogrel active metabolite, and clopidogrel inactive metabolite will be collected following the administration of the 10th (last) maintenance dose of each of the 2 Active Treatment Periods at 0.5, 1, 2, 4, and 6 hours post-dose.|After dose on Day 10 of Active Treatment Periods 1 and 2|1 Clopidogrel smoker participant was not evaluable for this measure.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
55294|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%|Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.||% participants with PRI <=50%|||Number
55295|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235||Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.||% participants with PRU <=235|||Number
55296|NCT01260584|Secondary|Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status|Day 10 occurs in each treatment period at which time data collections are made. Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.||% vasodilator stimulated phosphoprotein||Standard Error|Least Squares Mean
55297|NCT01260584|Secondary|Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status|"Day 10 occurs in each treatment period at which time data collections are made. 12.1.4. Responders and Poor Responders~Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose."|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.||P2Y12 reaction unit||Standard Error|Least Squares Mean
55298|NCT01260584|Primary|Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.|IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).|Baseline to day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.||percentage of device derived inhibition||Standard Error|Least Squares Mean
55299|NCT01260493|Primary|Satisfaction With Health and Social Care||1 year||||||
55300|NCT01260493|Primary|Dependence in Activities of Daily Living|Changes in number of person dependent in one or more daily activity from baseline to follow-up.|1 year|||participants|||Number
55301|NCT01260493|Primary|Health Care Consumption|Number of hospital days and admission will be analysed|1 year||||||
55302|NCT01260467|Secondary|Number of Participants With Adverse Events|This study will look at the number of participants who develop adverse events or side effects thought to be related to the memantine.|24 months|||participants|||Number
55303|NCT01260467|Primary|6 Month Progression-free Survival||24 months|not evaluated due to poor patient accrual|||||
55304|NCT01260467|Primary|Overall Survival||30 months|not evaluated due to poor patient accrual|||||
59239|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|6 weeks||||||
55306|NCT01260454|Secondary|Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score|Qutenza has not previously been used in patients with normal, healthy skin. We will assess the reaction to capsaicin in these patients as compared to the patients with unhealthy skin (post-herpetic neuralgia) who were studied in the registration trials for Qutenza. Pain immediately following Qutenza application was measured on a 10 point visual analog score with the word 'none' above 0 and 'agonizing' above 10.|60 minute period of patch application and subsequent 3 days|||participants|||Number
55307|NCT01260454|Primary|Pain Score on a Visual Analogue Scale|"Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded 0 for two consecutive days.~The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10)."|14 days after a new infusion site|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.||Visual Analogue Scale||Standard Deviation|Mean
55308|NCT01260350|Secondary|Percentage of Participants With Virologic Failure|"The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.~On-treatment virologic failure was defined as:~Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),~Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or~Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)~Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit."|Up to Posttreatment Week 24|Safety Analysis Set||percentage of participants|||Number
55309|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.|Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
55310|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Baseline to Week 8|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
55311|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline to Week 6|Safety Analysis Set||log10 IU/mL||Standard Deviation|Mean
55312|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.|Week 12|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
55313|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Week 8|Participants in the Safety Analysis Set with available data were analyzed.||percentage of participants|||Number
55314|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 6||Week 6|Safety Analysis Set||percentage of participants|||Number
55315|NCT01260350|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.|Posttreatment Week 12|Safety Analysis Set||percentage of participants|||Number
55316|NCT01260350|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to 12 weeks plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study medication.||Percentage of participants|||Number
55317|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].||incidence rate ratio||95% Confidence Interval|Number
55318|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].||incidence rate ratio||95% Confidence Interval|Number
55319|NCT01260324|Primary|Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)||01-January-2003 up to 31-December-2007|Participants from the NAION cases population adjudicated by medical record review.||participants|||Number
55320|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use|Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
55321|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
55322|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors|Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.|01-January-2003 up to 31-December-2007|Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years]. Only the covariates selected by the step wise regression procedure were summarized.||incidence rate per 1000 person-years||95% Confidence Interval|Number
55323|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
55324|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
55325|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
55326|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years [(NAION cases n, Controls n) / person-years].||incidence rate per 1000 person-years||95% Confidence Interval|Number
55327|NCT01260311|Other Pre-specified|Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
55328|NCT01260311|Other Pre-specified|Number of UUI Episodes Per 24 Hours at Week 4 and Week 8|UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
55329|NCT01260311|Other Pre-specified|Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8|Urgency episodes were defined as micturitions with USS rating of greater than or equal to (>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
55330|NCT01260311|Other Pre-specified|Number of Micturitions Per 24 Hours at Week 4 and Week 8|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.|||||
55343|NCT01260194|Secondary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population included all participants who had received at least 1 dose of study drug.||participants|||Number
59240|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks||||||
55331|NCT01260311|Primary|Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment|Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).|Baseline up to 28 days after last dose|Safety population defined as all participants who received at least one dose of study medication.||participants|||Number
55332|NCT01260272|Secondary|Change in High Density Lipoprotein Cholesterol Levels|Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
55333|NCT01260272|Secondary|Change in Waist Circumference|Raisin versus snacks: change in waist circumference from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||cm||Standard Error|Mean
55334|NCT01260272|Primary|Percent Change in Body Weight|Raisin versus snacks: percent change in body weight from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
55335|NCT01260272|Primary|Percent Change in Fasting Glucose Levels|Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||95% Confidence Interval|Median
55336|NCT01260272|Secondary|Change in Hemoglobin A1c|Raisin versus snacks: change in hemoglobin A1c from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
55337|NCT01260272|Secondary|Change in Diastolic Blood Pressure|Raisin versus snacks: change in diastolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||mmHg||Standard Error|Mean
55338|NCT01260272|Secondary|Change in Systolic Blood Pressure|Raisin versus snacks: change in systolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||mmHg||Standard Error|Mean
55339|NCT01260272|Primary|Percent Change in Postprandial Glucose Levels|Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.||Percent change from baseline||Standard Error|Mean
55340|NCT01260194|Secondary|Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer|The HER2 status was determination by using immunohistochemistry (IHC) and confirmatory Fluorescent In Situ Hybridization (FISH) techniques. Only participants with HER2 positivity were allowed to receive study medication.|Baseline|Safety population.||participants|||Number
55341|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|The LVEF was measured using Multi Gated Acquisition (MUGA) or echocardiography (echocardiography was preferred), using the same technique throughout for consistency in an individual participant. Baseline LVEF assessments were done within 21 days prior to the start of treatment. Participants with clinically significant change from baseline (that is, absolute drop in LVEF of >=15%, and drop to a value <50%) have been reported.|Baseline, thereafter every 12 weeks (maximum up to 22 months)|Safety population.||participants|||Number
55342|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Lab parameters assessed during the study were serum chemistry, biochemistry - serum electrolytes, hematology, 12 lead electrocardiogram, and urinalysis – protein, glucose, blood and other lab tests. Laboratory tests were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 3.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population.||participants|||Number
55359|NCT01259726|Secondary|Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools|Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.|Baseline (Day 1) up to Week 6|ITT-S population.||Participants|||Number
55360|NCT01259726|Secondary|Number of Participants With Use of Antibacterial Treatment for CDI|Any antibacterial medication used after Day 1 for which the investigator selected the indication “antibacterial for C. difficile infection”.|Baseline (Day 1) up to Week 6|ITT-S population.||Participants|||Number
55344|NCT01260194|Secondary|Duration of Response (DR)|DR was based on RECIST criteria v1.1 and was defined as time from date the CR or PR was first recorded to the date on which PD was first noted. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions and/or appearance of 1 or more new lesions. For the participants with no documented progression after CR or PR, the censored date (the date of “death,” the “last tumor measurement,” “last date in drug log,” or “last follow-up”) was taken into consideration. The median duration of response with 95% CI was estimated using Kaplan Meier method.|Baseline up to PD or death (maximum up to 22 months)|ITT population. The number of participants analyzed signifies the number of participants analyzed for this outcome measure.||days||95% Confidence Interval|Median
55345|NCT01260194|Secondary|Percentage of Participants With Clinical Benefit Response (CBR)|CBR was defined as any response among stable disease (SD) for 6 weeks or longer, CR, or PR as determined by the RECIST v 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to PD or death (maximum up to 22 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
55346|NCT01260194|Secondary|Percentage of Participants With Overall Tumor Response|Overall tumor response was defined as the occurrence of either a confirmed complete response (CR) or a partial response (PR) as best overall response as determined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1 from confirmed radio-graphic evaluations of target and non-target lesions. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<]10 mm); no new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions.|Baseline up to PD or death (maximum up to 22 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
55347|NCT01260194|Secondary|Overall Survival (OS)|OS was defined as the time from the date of enrollment to the date of the death (from any cause). If no death was observed, censored observations were taken into account in the analysis. The censoring date was the last date of “last tumor measurement,” “last date in drug log,” or “last follow-up.” The median overall survival time with 95% CI was estimated using Kaplan Meier method.|Baseline up to death (maximum up to 22 months)|ITT population.||days||95% Confidence Interval|Median
55348|NCT01260194|Primary|Median Progression Free Survival (PFS)|The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first. PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The censoring date was the last date of “last tumor measurement,” “last date of study drug treatment,” or “last follow-up.” The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method.|Baseline up to PD or death (maximum up to 22 months)|ITT population.||days||95% Confidence Interval|Median
55349|NCT01260142|Secondary|Relative Bioavailability of Fospropofol and Propofol|The PK parameters for propofol from propofol injectable emulsion were used as the reference formulation. Because propofol is a metabolite of fospropofol, all calculations were conducted after correcting for the different molecular weights of these formulations. Molecular weights of 332.24 (288.24 for free base) and 178.27 were used for fospropofol disodium and propofol injectable emulsion, respectively. The propofol parameters were adjusted as appropriate as discussed above and natural log transformed prior to comparison. Relative bioavailability of propofol from fospropofol disodium (E2083) to propofol from propofol injectable emulsion is calculated as (AUC(FP) x Total Dose of Propofol/AUC(P) x Total Dose of E2083) x Molecular fraction, where AUC(FP) is AUC(0-t) or AUC(0-inf) of propofol from E2083, AUC(P) is AUC(0-t) or AUC(0-inf) of propofol from propofol injectable emulsion and molecular fraction is molecular weight of propofol (178.27)/E2083 (332.24).|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ng x hr/mL||Standard Deviation|Mean
55350|NCT01260142|Secondary|Maximal Sedative Effect Using the Modified Observer's Assessment of Alertness/Sedation Scale|PD effects were determined from continuous BIS score recordings and from clinical assessment of sedation using the MOAA/S scale. The MOAA/S scale was used to rate the level of alertness/sedation from a score of 0 (does not respond to painful stimulus) to 5 (alert) in the category of responsiveness, with 5 being the MOAA/S value for a fully awake adult. Time to sedation was defined as the time from the first dose of study medication to the first two consecutive MOAA/S scores less than or equal to 4. Fully awake status was reached at the first of 3 consecutive MOAA/S scores of 5 measured every 2 minutes after study drug administration. The MOAA/S scale was described by the Emax model.|Days 1, and 7-14 (2 minutes prior to study drug administration and every 2 minutes thereafter for 20 minutes or until the subject reached Fully Alert status, whichever was later).|PD Analysis Set||Scores on a scale||Standard Deviation|Mean
55409|NCT01259245|Secondary|6 MWT in Meters|The 6 minute walking test ( 6MWT) was conducted according to protocol recommended by American Thoracic Society (ATS) guidelines to measure functional exercise capacity.This test measured the self paced distance in meters that a patient could quickly walk on a flat, hard surface in a period of 6 minutes.|6 months post-intervention|Intention to treat analysis||meters||Standard Deviation|Mean
55351|NCT01260142|Secondary|Maximal Sedative Effect Using the Bispectral Index (BIS) Score|Pharmacodynamic (PD) effects were obtained from continuous BIS score recordings obtained throughout the study and from clinical assessment of sedation using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. The BIS measurements continued until the participant was fully recovered in the opinion of the investigator or until the PD effect measure returned to baseline. The BIS score varied between 100 (associated with being fully awake) and 0 (associated with a flat line on the electroencephalogram (EEG)). The BIS Index was described by the maximal effect (Emax) model.|Days 1, and 7-14 (BIS measurements were to continue until the subject was fully recovered in the opinion of the investigator or until the PD effect measures returned to baseline measures)|PD analysis set included all participants who had sufficient PD data to derive at least one PD assessment.||Scores on a scale||Standard Deviation|Mean
55352|NCT01260142|Primary|Maximum Drug Plasma Concentration of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug/mL||Standard Deviation|Mean
55353|NCT01260142|Primary|Maximum Drug Plasma Concentration (Cmax) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug/mL||Standard Deviation|Mean
55354|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to Cmax, log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug.h/L||Standard Deviation|Mean
55355|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC(0-t)) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to maximum observed plasma concentration (Cmax), log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug.h/L||Standard Deviation|Mean
55356|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Propofol|An A-line and V-line were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of propofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC(0-t) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set||ug.h/L||Standard Deviation|Mean
55357|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf))|AUC(0-inf) is a measure of drug concentration equal to the area under the plasma concentration-time profile from time 0 to infinity. An arterial line (A-line) and venous line (V-line) were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of fospropofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC from time 0 to time t (AUC(0-t)) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|Pharmacokinetic (PK) Analysis Set is the group of participants who have sufficient pharmacokinetic data to derive at least one PK parameter.||ug.h/L||Standard Deviation|Mean
55358|NCT01259726|Secondary|Time to First CDI Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable.|Baseline (Day 1) up to Week 6|ITT-S population||days||Full Range|Median
55361|NCT01259726|Secondary|Number of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.|Baseline (Day 1) up to Week 6|ITT-S population.||Participants|||Number
55362|NCT01259726|Primary|Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3||After study drug administration period (14 days) through Week 6|ITT-S population.||Participants|||Number
55363|NCT01259726|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.|Baseline up to 7 days after the last dose of study drug (up to Week 3)|Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.||Participants|||Number
55364|NCT01259713|Secondary|Percentage of Participants With Complete Remission at the End of Remission Induction|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
55365|NCT01259713|Secondary|Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||days||Inter-Quartile Range|Median
55366|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the Investigator.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
55367|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the IDRB.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
55368|NCT01259713|Secondary|Percentage of Participants Requiring Antifungal Treatment During Remission-Induction Chemotherapy||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
55369|NCT01259713|Secondary|Time to Diagnosis of Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the IDRB.|Time to diagnosis of proven or probable IFIs is presented as the median (Q1,Q3) days to diagnosis of those participants who experienced a proven or probable IFI. Median was not reached if < 50% of participants had an event; Q1 was not reached if < 25% of participants had an event; Q3 was not reached if < 75% of participants had an event.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||days||Inter-Quartile Range|Median
55370|NCT01259713|Secondary|Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
55371|NCT01259713|Secondary|Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set||percentage of participants|||Number
55372|NCT01259713|Primary|Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)|"Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment.~The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy."|During remission-induction chemotherapy (average 7 weeks)|Intent-to-Treat (ITT) Analysis Set: participants in the safety analysis set who had no major violations of entrance criteria.||percentage of participants|||Number
55373|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment|"The ASRS is a self-rating scale designed to assess ADHD symptoms in adults and is now part of the World Health Organization Composite International Diagnostic Interview. It consists of 18 items written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often). The total score ranges from 0 to 72."|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a scale||Standard Deviation|Mean
55381|NCT01259492|Secondary|Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners’ Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)|"DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often)."|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2||Score on Scale||Standard Deviation|Mean
55374|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment|CAARS is an instrument to assess ADHD symptoms and behaviors in adults. This study utilizes the Observer Short Version (CAARS-O: S), consisting of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index (to distinguish ADHD adults from non-clinical adults), and Inconsistency Index (to identify random or careless responding) and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The observer is asked to notice the patient carefully and decide how much or how frequently each of the 26 items of the scale describes the patient recently. The response to every question in increasing order of severity is “not at all, never = 0; Just a little, once in a while = 1; Pretty much, often = 2; Very much, very frequently = 3”. The total score combined from all the 26 items ranges from 0 to 88.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a scale||Standard Deviation|Mean
55375|NCT01259492|Secondary|Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|CGI-S assesses the patient’s current illness state. CGI-S consists of 7 ratings that range from 1 = “normal, not at all ill” , 2 = “borderline mentally ill”, 3 =” mildly ill”, 4 = “moderately ill”, 5 = “markedly ill”, 6 = “severely ill”, 7 = “among the most extremely ill patients”|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.||Participants|||Number
55376|NCT01259492|Secondary|Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is “no change”, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = “Very much improved” to 7 =“Very much worse”. Improvement on the CGI-I scale is defined as a visit rating of 1 “very much improved” or 2 “much improved” on the CGI-I scale.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.||participants|||Number
55377|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment|The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient’s work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more “impaired” a patient’s work, social life, family life is.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a Scale||Standard Deviation|Mean
55378|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment|The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.||Units on a Scale||Standard Deviation|Mean
55379|NCT01259492|Secondary|Number of Participants With Clinical Global Impression – Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)|CGI-S assesses the patient’s current illness state. CGI-S consists of 7 ratings that range from 1 = “normal, not at all ill” , 2 = “borderline mentally ill”, 3 =” mildly ill”, 4 = “moderately ill”, 5 = “markedly ill”, 6 = “severely ill”, 7 = “among the most extremely ill patients”|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2; Patients with CGI-S assessment both at Baseline 1 and Period 2 was included.||number of participants|||Number
55380|NCT01259492|Secondary|Number of Participants With Clinical Global Impression – Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)|CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = “very much improved”, 2 = “much improved”, 3 = “minimally improved”, 4 = “no change from baseline”, 5 = “minimally worse”, 6 = “much worse” 7 = “very much worse”|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2 Patients with CGI-I assessment both at Baseline 1 and Period 2 was included.||number of participants|||Number
55382|NCT01259492|Secondary|Percentage of Patients With Improvement on Clinical Global Impression – Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1|On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is “no change”, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = “Very much improved” to 7 =“Very much worse”. Improvement on the CGI-I scale is defined as a visit rating of 1 “very much improved” or 2 “much improved” on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N * 100.|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Evaluable patients with both baseline and post-baseline (end of week 9) assessments were included.||Percentage of Patients|||Number
55383|NCT01259492|Primary|Percentage of Participants With Treatment Failures During Period 3|Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 – DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) >= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 – DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) > - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54|Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. One patient in Ritalin LA 80mg did not have post baseline 2 measurements and was not included in the categories under without imputation.||Percentage of participants|||Number
55384|NCT01259492|Primary|Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment|SDS, a 5-self-rated questionnaire to measure the extent a pt’s disability due to an illness/health problem interferes with work/school, social life/leisure, family life/home. First 3 items, pts are asked how their symptoms disrupted their reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. subscale(work disability, social life disability, family life disability) can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairmt. Subscale scores >5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.||Units on a Scale||Standard Deviation|Mean
55385|NCT01259492|Primary|Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (Never) to 4 (Very often). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 – DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) <= - 30%."|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.||Units on a Scale||Standard Deviation|Mean
55386|NCT01259466|Secondary|Percent Weight Change|% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100|Post-treatment (12 weeks)|||Percent weight change||Standard Deviation|Mean
55387|NCT01259466|Primary|Number of Participants With Verified Smoking Cessation (Abstinence)|Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)|Post-treatment (12-weeks)|||participants|||Number
55388|NCT01259440|Primary|Treatment Adherence|Nightly CPAP adherence measured over the two-month period .|2 months|||hours/night||Standard Deviation|Mean
55389|NCT01259427|Secondary|Social Engagement/Withdrawal|The total score of the Social Engagement/Withdrawal subscale of the Social Functioning Scale was used to measure social engagement. The total score ranges from 0 to 15 with higher scores indicating greater social engagement.|~3 1/2 months (post-treatment)|||unit on a scale||Standard Deviation|Mean
55390|NCT01259427|Secondary|Quality of Life|The Satisfaction with Life in General item from the Brief Quality of Life Scale was used to assess self-reported life satisfaction. The item is rated on a 7-point scale that ranges from terrible to delighted (range=1 to 7), with greater scores indicating more satisfaction.|~3 1/2 months (post-treatment)|||units on a scale||Standard Deviation|Mean
55391|NCT01259427|Primary|Sense of Belonging Instrument (Belonging)|The Sense of Belonging Instrument was used to measure perceived belongingness. The measure includes two subscales: the psychological experience of belonging (SOBI-P) and antecedents that foster belonging (SOBI-A). An average of the sum of the items in each subscale were used to calculate the total score for that subscale. The total score of the SOBI-P ranges from 18 to 72, with higher scores indicating less experienced belonging. The total score of the SOBI-A ranges from 14-56 with higher score indicating greater antecedents that foster belonging.|~3 1/2 months (post-treatment)|||units on a scale||Standard Deviation|Mean
55392|NCT01259427|Primary|General Self-Efficacy Scale|The General Self-efficacy measure was used to measure of self-efficacy. A total score was calculated by averaging the responses on the items (range=1 to 5), with higher scores indicating greater self-efficacy.|~3 1/2 months (post-treatment)|||unit on a scale||Standard Deviation|Mean
55393|NCT01259427|Primary|Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~3 1/2 months (post-treatment)|||units on a scale||Standard Deviation|Mean
55394|NCT01259427|Primary|Internalized Stigma of Mental Illness Inventory (Internalized Stigma)|The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.|~3 months (post-treatment)|||units on a scale||Standard Deviation|Mean
55395|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy.|4-month follow-up|Two SIP subjects had missing data for this variable.||percentage of time in bed asleep||95% Confidence Interval|Mean
55397|NCT01259297|Secondary|Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen|The total mortality endpoint was defined as time to death from any cause. Total mortality analysis used the date of last follow-up including the washout period as the censoring date.|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||Participants|||Number
55398|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Mean sitting diastolic blood pressure (msDBP) is the average of 2 sitting DBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.||mmHg||Standard Error|Least Squares Mean
55399|NCT01259297|Secondary|Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|"The renal dysfunction (composite endpoint) was defined as the first occurrence of either of the following:~End-stage renal disease [ESRD] requiring dialysis or transplantation~Doubling of serum creatinine and reaching an eGFR < 45 ml/min/1.73 m^2."|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||participants|||Number
55400|NCT01259297|Secondary|Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE was comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in the last month. Each question’s score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)).~Part II of SAGE included 2 dimensions:~Normal if the scores of all SAGE questions is 0 (i.e., No difficulty)~Mobility Only if scores of both SAGE questions 11 and 12 are 0"|End of study (209 days [median])|Full Analysis Set. Number of patients with all SAGE questions non-missing for the specific visit are included in this population. Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn.||percentage of participants|||Number
55401|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||participants|||Number
55402|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Mean sitting systolic blood pressure (msSBP) is the average of 2 sitting SBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.||mmHg||Standard Error|Least Squares Mean
55403|NCT01259297|Secondary|Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in last month. Each question’s score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part I of SAGE included 4 dimensions:~Community Cognition (maximum of scores of questions 1 to 6);~Instrumental Activities of daily Living (IADL) (maximum of scores of questions 7 to 10);~Mobility (maximum of scores of questions 11 and 12);.~Basic Activities of daily Living (ADL) (maximum of scores of questions 13 to 15) Each dimension’s total score ranged from 0 to 3. 0=best, 3=worst A negative change in value from baseline means improvement in the ability to perform everyday activities."|Baseline, End of study (209 days [median])|Full Analysis Set: Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn. Patients who completed both baseline and post-baseline SAGE questionnaires (Part II) were included in this analysis.||units on a scale||Standard Deviation|Mean
55404|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.||participants|||Number
55405|NCT01259284|Primary|Incidences of Atrial Fibrillation During First 4 Days After Lung Resection|New onset of sustained (15 min or >) or clinically significant (requiring intervention) atrial fibrillation (AF) during first 4 days post surgery as defined by on American College of Cardiology and American Heart Association Physician Consortium.|Baseline to 4 days post surgery|Analysis was to be per protocol. There is no analysis due to an inadequate number of enrolled participants in study which resulted in early termination.|||||
55410|NCT01259245|Primary|SGRQ HKC Total|SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
55411|NCT01259245|Primary|SGRQ HKC-Impact|SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|intention to treat||units on a scale||Standard Deviation|Mean
55412|NCT01259245|Primary|SGRQ HKC-Activity|SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
55413|NCT01259245|Primary|SGRQ HKC-Symptoms|SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
55414|NCT01259245|Primary|Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)|The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients’ overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.|Change in SEMSOB at 6 months post-intervention|Intention to treat||units on a scale||Standard Deviation|Mean
55415|NCT01259245|Primary|Self Efficacy :COPD Self Efficacy Scale (CSES)|"34 item questionnaire consisting of likert scale with 5 responses ranging from 1 indicating  not at all confident to 5 indicating  very confident with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as not at all confident and 1 as very confident. The validated Chinese version of CSES was also used"|Change in CSES at 6 months post-intervention|Intention to treat was used in the analysis||rating score of 0.2 to 1||Standard Deviation|Mean
55416|NCT01259115|Secondary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments consisted of monitoring and recording medical history, physical examinations, vital signs (including temperature, heart rate, blood pressure and respiratory rate), reports of adverse experiences, and laboratory abnormalities (including electrocardiogram [ECG]).|The first day of study drug administration to 30 days after the last dose of study drug.|Safety Population: Safety analyses were performed on all subjects who received at least 1 dose of study drug and for whom at least 1 postdose safety observation was recorded.||participants|||Number
55417|NCT01259115|Primary|Cmax of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
55418|NCT01259115|Primary|AUCinf of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||||
55419|NCT01259115|Primary|AUCt of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
55420|NCT01259115|Primary|Cmax of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
59241|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|16 weeks||||||
55421|NCT01259115|Primary|AUCinf of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
55422|NCT01259115|Primary|AUCt of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
55423|NCT01259115|Primary|Cmax of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
55424|NCT01259115|Primary|AUCinf of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
55425|NCT01259115|Secondary|CYP3A4 Inhibition by Observation of Plasma Nor-buprenorphine Production Assessed by the Erythromycin Breath Test.|As part of subject screening, Erythromycin Breath Tests (EBT) were done on all potential subjects (enrolled population). CYP 3A4 inhibition was calculated by taking the difference of the baseline 14C erythromycin metabolism, subtracting the 14C erythromycin metabolism during ketoconazole treatment, dividing this difference by the baseline 14C erythromycin metabolism, and multiplying by 100 to express results in the form of percent inhibition. CYP3A4 inhibition was only done when subjects were on ketoconazole.|One time at screening and one time during ketoconazole treatment|Enrolled Population: All subjects who participated in the study. CYP3A4 Inhibition was only done when subjects were on Ketoconazole.||Percentage of participants||Standard Deviation|Mean
55426|NCT01259115|Primary|AUCt of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL*h||Standard Deviation|Mean
55427|NCT01259115|Primary|Cmax of Buprenorphine With and Without Ketoconazole.|"Cmax (maximum observed plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral tablets twice daily,~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||pg/mL||Standard Deviation|Mean
55438|NCT01259102|Primary|Period 2: AUC0-3d.|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d.~AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
59242|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|14 weeks||||||
55428|NCT01259115|Primary|AUCinf of Buprenorphine With and Without Ketoconazole.|"AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.||pg /mL•h||Standard Deviation|Mean
55429|NCT01259115|Primary|AUCt of Buprenorphine With and Without Ketoconazole.|"AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or Ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.||pg/mL*h||Standard Deviation|Mean
55430|NCT01259102|Secondary|Period 2: Tmax0-7d.|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||hour||Standard Error|Mean
55431|NCT01259102|Secondary|Period 1: Tmax0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||hour||Standard Error|Mean
55432|NCT01259102|Secondary|Period 2: Cmax0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
55433|NCT01259102|Secondary|Period 1: Cmax0-7|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
55434|NCT01259102|Secondary|Period 2: AUC0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
55435|NCT01259102|Secondary|Period 1: AUC0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
55436|NCT01259102|Primary|Period 2: Cmax0-3d|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
55437|NCT01259102|Primary|Period 1: Cmax0-3d|"Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL||Standard Error|Mean
55457|NCT01258985|Secondary|Change in Medical Outcomes Short Form-36 PCS|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
55439|NCT01259102|Primary|Period 1: AUC0-3d|Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)].|0 to 3 days (72 hours)|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.||pg/mL*h||Standard Error|Mean
55440|NCT01258998|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity data will be summarized by frequency tables. The association between both type and severity of toxicity and the treatment groups will be evaluated.|Up to 30 days||||||
55441|NCT01258998|Secondary|Change in Biomarker Levels of Interest (Akt, pAKT, and Apoptosis [Annexin-V])|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment||||||
55442|NCT01258998|Secondary|Change in Chemokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment||||||
55443|NCT01258998|Secondary|Change in Cytokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment||||||
55444|NCT01258998|Secondary|Overall Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 30 days||||||
55445|NCT01258998|Secondary|Duration of Response|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days||||||
55446|NCT01258998|Secondary|Progression-free Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days||||||
55447|NCT01258998|Primary|Objective Response Rate (ORR)|Objective response rate. Logistic regression utilized to assess the effect of patient demographic factors on OR.|4 months|Based on intent-to-treat analysis.||participants|||Number
55448|NCT01258985|Secondary|Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.|From Week 0, to week 24 or to week 52|||units on a scale||95% Confidence Interval|Mean
55449|NCT01258985|Secondary|Outcome Expectation Scale|The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.|Week 0|||units on a scale||Standard Deviation|Mean
55450|NCT01258985|Secondary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
55451|NCT01258985|Secondary|Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
55452|NCT01258985|Secondary|Change in Arthritis Self-Efficacy Scale|The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
55453|NCT01258985|Secondary|Change in Beck II Depression Inventory|Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
55454|NCT01258985|Secondary|Change in Patient Global VAS|Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|From Week 0, to Week 12, or to week 24, or to week 52|||units on a scale||95% Confidence Interval|Mean
55455|NCT01258985|Secondary|Change in 20 Meter Walk Test|the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability|From Week 0, to Week 12, or to week 24, or to week 52|||seconds||95% Confidence Interval|Mean
55456|NCT01258985|Secondary|Change in 6 Minute Walk|The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.|From Week 0, to Week 12, or to week 24, or to week 52|||meters||95% Confidence Interval|Mean
59243|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|8 weeks||||||
55458|NCT01258985|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks|The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.|From Week 0 to Week 12|||units on a scale||95% Confidence Interval|Mean
55459|NCT01258803|Secondary|Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose FVC measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55460|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55461|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55462|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55463|NCT01258803|Secondary|Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55464|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55465|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55602|NCT01256944|Primary|HDL|"Metabolic syndrome was defined (2005 National Cholesterol Education Program, Adult Treatment Panel III) as the presence of at least three of the following criteria:~abdominal obesity (waist circumference >80 cm in women); serumtriglycerides≥1.7 mmol/L; serumHDL<1.3 mmol/L; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg; and fasting plasma glucose ≥7.0 mmol/L."|1 year|||mmol/L||Standard Deviation|Mean
55466|NCT01258803|Primary|Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment||Liters||Standard Error|Least Squares Mean
55467|NCT01258790|Primary|Yale Global Tic Severity Scale|The tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.|1 week|||units on a scale (0 - 50)||Standard Deviation|Mean
55468|NCT01258738|Secondary|Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points|PASS is defined as a symptom state that the participants consider acceptable.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55469|NCT01258738|Secondary|Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points|The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are “Improved - less pain”, “No change”, and “Worse – more pain.” If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from “Not at all important” to “Very important’.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55470|NCT01258738|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104|The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55471|NCT01258738|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points|"The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, I tire easily) are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, I feel fit) a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by “Yes, that is true” (scored 1) to “No, that is not true” (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55472|NCT01258738|Secondary|Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent overall work impairment due to health problem:~Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55473|NCT01258738|Secondary|Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55603|NCT01256944|Primary|Triglycerides|Abnormal serum triglycerides defined as ≥ 1.7 mmol/L|1 year|||mmol/L||Standard Deviation|Mean
55474|NCT01258738|Secondary|Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55475|NCT01258738|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55476|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points|The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual’s ability levels given their AS and their job. Each question is assigned a score of 1 for a response of “True” and 0 for a response of “Not True”. All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55477|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55478|NCT01258738|Secondary|Change From Baseline in HADS Anxiety Score at Time Points|This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55479|NCT01258738|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points|This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55480|NCT01258738|Secondary|Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55481|NCT01258738|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55482|NCT01258738|Secondary|Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||Units on a scale||Standard Error|Mean
55483|NCT01258738|Secondary|Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||mm||Standard Error|Mean
55484|NCT01258738|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||mm/hr||Standard Error|Mean
55485|NCT01258738|Secondary|Change From Baseline in C-reactive Protein (CRP) Concentration Time Points|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||mg/L||Standard Error|Mean
55486|NCT01258738|Secondary|Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55487|NCT01258738|Secondary|Mean Change From Baseline in Dactylitis Score at Time Points|Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55488|NCT01258738|Secondary|Mean Change From Baseline in Number of Tender Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Number of joints||Standard Error|Mean
55489|NCT01258738|Secondary|Mean Change From Baseline in Number of Swollen Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Number of joints||Standard Error|Mean
55490|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score|ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases||Units on a scale||Standard Error|Mean
55491|NCT01258738|Secondary|Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.||units on a scale||Standard Error|Mean
55492|NCT01258738|Secondary|Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points|The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.||units on a scale||Standard Error|Mean
55493|NCT01258738|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.||units on a scale||Standard Error|Mean
55494|NCT01258738|Secondary|Mean Change From Baseline in Occiput-to-wall Test at Time Points|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||cm||Standard Error|Mean
55495|NCT01258738|Secondary|Change From Baseline in Chest Expansion at Time Points|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||cm||Standard Error|Mean
55496|NCT01258738|Secondary|Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55497|NCT01258738|Secondary|Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55498|NCT01258738|Secondary|Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55499|NCT01258738|Secondary|Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55604|NCT01256944|Primary|Cholesterol|Hypercholesterolemia was defined as >6 mmol / L.|1 year|||mmol/L||Standard Deviation|Mean
59244|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|6 weeks||||||
55500|NCT01258738|Secondary|Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55501|NCT01258738|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55502|NCT01258738|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points|The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55503|NCT01258738|Secondary|Percentage of Participants With BASDAI 20 at Time Points|Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55504|NCT01258738|Secondary|Percentage of Participants With BASDAI 50 at Time Points|Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55505|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55506|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55507|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55516|NCT01258738|Secondary|Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55508|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Discomfort at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55509|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55510|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55511|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55512|NCT01258738|Secondary|Mean Change From Baseline in BASFI Putting on Socks at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55513|NCT01258738|Secondary|Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55514|NCT01258738|Secondary|Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55515|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55541|NCT01258660|Primary|Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected)|The Area under the curve (AUC) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment|||nmol·week/L||95% Confidence Interval|Geometric Mean
59245|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks||||||
55517|NCT01258738|Secondary|Mean Change From Baseline in BASFI Reaching up High at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55518|NCT01258738|Secondary|Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55519|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55520|NCT01258738|Secondary|Mean Change From Baseline in BASFI Bending Forward at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55521|NCT01258738|Secondary|Mean Change From Baseline in BASFI Full Day Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55522|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55523|NCT01258738|Secondary|Changes From Baseline in VAS Score for Total Back Pain at Time Points|The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
55524|NCT01258738|Secondary|Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points|The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
55525|NCT01258738|Secondary|Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points|Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
55526|NCT01258738|Secondary|Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points|The Investigator estimated the participant’s overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.||cm||Standard Error|Mean
55527|NCT01258738|Secondary|Time to ASAS Partial Remission|The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.||percentage of participants||95% Confidence Interval|Number
55528|NCT01258738|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Time Points|Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55529|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points|ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Units on a scale||Standard Error|Mean
55530|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 5/6 Response at Time Points|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55531|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 20 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55532|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 40 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.||Percentage of participants|||Number
55533|NCT01258738|Primary|Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 12|Modified intent-to-treat (mITT) population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for axial spondyloarthritis (AxSpA). Missing data were imputed through last observation carried forward (LOCF) approach.||Percentage of participants|||Number
55534|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid|baseline, and up to 24 weeks of treatment|||µmol/L||Standard Deviation|Mean
55535|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin|baseline and week 24|||µmol/L||Standard Deviation|Mean
55536|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 6|Folate metabolite pattern in plasma at cycle 6|week 24|||nmol/L||Standard Deviation|Mean
55537|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 3|Folate metabolite pattern in plasma at cycle 3|week 12|||nmol/L||Standard Deviation|Mean
55538|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Baseline|Folate metabolite pattern in plasma at baseline|pre-treatment|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||Standard Deviation|Mean
55539|NCT01258660|Primary|Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)|Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)|from week 24 to week 44|||proportion of participants|||Number
55540|NCT01258660|Primary|Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment|||nmol·week/L||95% Confidence Interval|Geometric Mean
55605|NCT01256944|Primary|Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)|HOMA-IR = [fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)]/405.|1 year|||unitless||Standard Deviation|Mean
55542|NCT01258595|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.||Participants|||Number
55543|NCT01258595|Primary|Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post vaccination|Seroprotection was assessed in the full analysis set population.||Percentage of Participants|||Number
55544|NCT01258595|Primary|Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|"Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.~Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method."|Day 0 and Day 28 post-vaccination|Seroconversion to the vaccine antigens was assessed in the full analysis set population.||Percentage of Participants|||Number
55545|NCT01258595|Primary|Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 Post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
55546|NCT01258595|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
55547|NCT01258582|Primary|Acceptability of the HIV Test|The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).|Assess on day subject enrolled into the study|Intent to treat analysis||proportion of participants||95% Confidence Interval|Number
55548|NCT01258504|Primary|Cmax of Bosentan||after first dose, at steady-state and during SJW|||ng/ml||95% Confidence Interval|Geometric Mean
55549|NCT01258504|Primary|AUC of Bosentan||0-infinity; during dosing interval|||h*ng/ml||95% Confidence Interval|Geometric Mean
55550|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From end of treatment period up to Week 48 (follow-up period)|All follow-up participants.||participants|||Number
55551|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.|Baseline (Day 1) up to 24 weeks (treatment period)|All treated participants.||participants|||Number
55552|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
55553|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 3. Here, n signifies the number of participants evaluable for the respective category."||participants|||Number
55566|NCT01258153|Secondary|Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test.|Safety and tolerability will be assessed for the Safety Population (all patients who received the study drug) in terms of frequency and severity of AEs as well as frequency of clinically significant changes in physical examination and lab test.|up to four weeks|All patients receiving the study drug (114)||Adverse events|||Number
55628|NCT01257750|Primary|Non-Ocular (Systemic) Adverse Events|Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs (blood pressure and heart rate) through week 12|12 Weeks|All enrolled patients were analyzed.||participants|||Number
55554|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 2. Here, n signifies the number of participants evaluable for the respective category."||participants|||Number
55555|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
55556|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 2.||percentage of participants||80% Confidence Interval|Number
55557|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
55558|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 2.||percentage of participants||80% Confidence Interval|Number
55559|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 3.||percentage of participants||80% Confidence Interval|Number
55560|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 2.||percentage of participants||80% Confidence Interval|Number
55561|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with hepatitis C virus genotype 2.||percentage of participants||80% Confidence Interval|Number
55562|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)|"ESV is the volume of blood remaining in each ventricle at the end of systole.¹~¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population||Milliliter(s)||Standard Deviation|Mean
55563|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)|"EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹~¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population||Milliliter(s)||Standard Deviation|Mean
55564|NCT01258387|Secondary|Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)|"An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹~Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.²~¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/~²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population||percent change||Standard Deviation|Mean
55565|NCT01258387|Primary|Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)|"Safety/ tolerability of single dose; cumulative safety over 6 months~TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment."|6 months|Safety population||participants|||Number
55606|NCT01256944|Primary|Two Hour Glucose|"2-hour postprandial blood sugar measures blood glucose exactly 2 hours after you start eating a meal. This is not a test used to diagnose diabetes.~World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year|||mmol/L||Standard Deviation|Mean
55567|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|10 days|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment||Score range 0-5|Participants|Standard Deviation|Mean
55568|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|1 week|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment||Score range 0-5|Participants|Standard Deviation|Mean
55569|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|1 day|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment||Score range 0-5|Participants|Standard Deviation|Mean
55570|NCT01258153|Secondary|Percentage of 'Responder' Babies at the End of Treatment Period.|Response is defined as a decrease of at least 50% of crying and fussing time during the last 3 days on treatment vs baseline.|baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured||Responders Rate (% of responders babies)|||Number
55571|NCT01258153|Primary|Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.|Efficacy assessment to be measured through “baby’s day” diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration).|Baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured||Minutes||Standard Deviation|Mean
55572|NCT01258101|Secondary|Time to Viral Response|Time to viral response was calculated as Date of first negative PCR result after screening – date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported.|Up to Week 48|Standard analysis population includes all randomized participants.||Days||Standard Deviation|Mean
55573|NCT01258101|Secondary|Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48|For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
55574|NCT01258101|Secondary|Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48|Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1=”stark” (affliction is strong) to 4=”gar nicht” (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
55575|NCT01258101|Secondary|Mean FSS Scores at Baseline and Weeks 16, 24 and 48|The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
55576|NCT01258101|Secondary|Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48|Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.||Score on a scale||Standard Deviation|Mean
55577|NCT01258101|Secondary|Median Hemoglobin Levels at End of Treatment|Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.|At Week 16 and Week 24|The Safety analysis population was defined to include only participant who received at least one dose of (either) study medication and had at least one post-baseline safety assessment.||g/L||Inter-Quartile Range|Median
55598|NCT01258049|Primary|Parasitological Success (MITT)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|"The Modified Intention to Treat (MITT) population included all randomised subjects who received at least one dose of study medication and had evaluable parasite counts at 24 hours after first dosing.~7 subjects for ArTiMist and 3 subjects for quinine were excluded due to no baseline or 24 h parasite count"||participants|||Number
75041|NCT01056718|Secondary|Resting EF||10 Weeks|||Percent of LV end diastolic volume||Standard Deviation|Mean
55578|NCT01258101|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|The Safety analysis population was defined to include only participants who received at least one dose of (either) study medication and had at least one post-baseline assessment.||Number of Participants|||Number
55579|NCT01258101|Secondary|Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment|Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
55580|NCT01258101|Secondary|Percentage of Participants With Virological Response at the End of the Treatment|Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
55581|NCT01258101|Primary|Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48|Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.|At Week 24 and Week 48|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
55582|NCT01258101|Primary|Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment|Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.|Up to Week 48 (24 weeks post completion of the treatment)|Standard analysis population includes all randomized participants.||Percentage of participants||95% Confidence Interval|Number
55583|NCT01258049|Secondary|Number of Deaths or Neurological Sequelae at Day 28||28 days after start of treatment|||participants|||Number
55584|NCT01258049|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities||28 days after start of treatment|||participants|||Number
55585|NCT01258049|Secondary|Time to Return to Normal Per os Status|Time in hours to return to normal per os status. Normal per os was when the investigator considered the patient to be able to eat and drink normally.|28 days after start of treatment|||hours||Standard Deviation|Mean
55586|NCT01258049|Secondary|Time to Return to Full Consciousness|"Time in hours to return to full consciousness (Blantyre Coma Scale = 5), if level of consciousness is reduced (Blantyre Coma Scale <5) prior to dosing or within 24hours of first dosing.~For the Blantyre Coma Scale~Total - maximum 5, eye movement - maximum 1, best motor response - maximum 2, best verbal response - maximum 2"|28 days after start of treatment|||hours||Standard Deviation|Mean
55587|NCT01258049|Secondary|Late Parasitological Failure|o Parasitaemia on any day from Day 7 to Day 28 and tympanic temperature ≤ 38.0°C|28 days after the start of treatment|||participants|||Number
55588|NCT01258049|Primary|Parasitological Success (PP)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|The Per Protocol (PP) population included the subjects in the MITT population who had received at least 80% of doses up to the time of discharge from the hospital, had evaluable data up to and including Day 28 and had no major protocol violations.||participants|||Number
55589|NCT01258049|Secondary|Late Clinical Failure|"Signs of severe malaria on any day between Day 4 and Day 28 in the presence of parasitaemia, without previously meeting any of the criteria of early treatment failure~Presence of parasitaemia and tympanic temperature ≥ 38.0°C (or history of fever), on any day between Day 4 and Day 28, without previously meeting any of the criteria of early treatment failure"|28 days after the start of treatment|||participants|||Number
55590|NCT01258049|Secondary|Early Treatment Failure|"Early treatment failure is indicated by one or more of the following:~Parasite count on Day 2 > Day 0, irrespective of temperature~Parasite count on Day 3 > 0 with tympanic temperature ≥ 38.0°C~Parasite count on Day 3 ≥ 25% of baseline~Administration of rescue antimalarial treatment"|Three days after the start of treatment|||participants|||Number
55591|NCT01258049|Secondary|Complete Cure Rate|The complete resolution of clinical signs and symptoms, malaria-related laboratory abnormalities, and elimination of asexual parasites by Day 7, with no recurrence up to Day 28 (+/- 2 days), and the 48h parasite count to be < 25% of baseline with no clinical deterioration|28 days after the start of treatment|For some subjects, this endpoint was not evaluable and/or not all data was received.||participants|||Number
55592|NCT01258049|Secondary|Fever Clearance Time (FCT)|Time in hours from the initiation of therapy until the disappearance of fever (tympanic temperature < 38.0) that lasted at least 24 hours.|28 days after start of treatment|||hours||Standard Deviation|Mean
55593|NCT01258049|Secondary|PRR 12 [MITT Population]|The percentage reduction in parasite counts 12 hours after first dose|28 days after start of treatment|||percentage of baseline||Standard Deviation|Mean
55594|NCT01258049|Secondary|PRR 24 [MITT Population]|The percentage reduction in parasite counts 24 hours after first dose|28 days after start of treatment|||percentage of baseline||Standard Deviation|Mean
55595|NCT01258049|Secondary|PCT 50 [MITT Population]|Time for parasite counts to fall by 50%|28 days after start of treatment|||hours||Standard Deviation|Mean
55596|NCT01258049|Secondary|PCT 90 [MITT Population]|Time for parasite counts to fall by 90%|28 days after start of treatment|||hours||Standard Deviation|Mean
55597|NCT01258049|Secondary|Parasite Clearance Time (PCT) [MITT Population]|Parasite clearance time (PCT). Time in hours from the initiation of therapy until the first of two successive parasite negative smears (zero parasite counts) are obtained|28 days after start of treatment|||hours||Standard Deviation|Mean
55607|NCT01256944|Primary|Fasting Glucose|"Fasting blood sugar (FBS) measures blood glucose after you have not eaten for at least 8 hours. It is often the first test done to check for prediabetes and diabetes.~World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year|||mmol/L||Standard Deviation|Mean
55608|NCT01256944|Primary|Fasting Insulin|A fasting serum insulin level of greater than the upper limit of normal for the assay used (approximately 60 pmol/L) is considered evidence of insulin resistance.|1 year|||μIU/ml||Standard Deviation|Mean
55609|NCT01256944|Primary|BMI|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).|1 year|||kg/m2||Standard Deviation|Mean
55610|NCT01256944|Primary|Total Testosterone|Using serum total testosterone to represent the severity of hyperandrogenism.|1 year|||nmol/L||Standard Deviation|Mean
55611|NCT01256918|Primary|Correlation Between Lens Thickness and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between~length thickness measurement using A scan biometer for each cataract and~penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery|||units on a scale||Standard Deviation|Mean
55612|NCT01256918|Primary|Correlation Between Nuclear Opalescence and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between~nuclear opalescence as per LOCS III grading system for each cataract and~penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery|||units on a scale||Standard Deviation|Mean
55613|NCT01256918|Primary|Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification|the nuclear colour grading as per LOCS III criteria for each case and the depth of penetration of phacotip required during a vertical chop was analysed to look for any correlation between the two.|day 0 of surgery|||units on a scale||Standard Deviation|Mean
55614|NCT01256918|Secondary|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .|day 0 of surgery.|". In this observational study sample size was achieved by consecutive sampling of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria from Nov.2010 till March 2011 ,after a written informed consent.~Occurence of any posterior capsular rupture during vertical chop was noted as per protocol."||participants|||Number
55615|NCT01256918|Primary|Phacodepth Required to Achieve Full Thickness Nuclear Crack|phacodepth is the term used to describe the depth penetrated by the phacotip into the substance of lens.A note of depth penetrated by the tip to achieve full thickness nuclear crack shall be made.|day 0 of surgery|A consecutive sample of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria, were enrolled in the study starting Nov.2010 till Jan 2011 ,after a written informed consent.||mm||Standard Deviation|Mean
55616|NCT01255137|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse events module.|3/2/11 - 8/2/12|||Participants|||Number
55617|NCT01255137|Primary|Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameter. Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: the appearance of one or more new lesions is also considered progression). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum diameters while on study.|2 years|||Participants|||Number
55618|NCT01257880|Secondary|White Matter Lesions|Presence and severity of white matter lesions on magnetic resonance imaging, taken within 5 years prior to study enrollment. Subjects will not have magnetic resonance imaging performed as part of this study. Films will be requested and an independent neuroradiologist will assess presence of white matter lesions.|Within 5 years prior to enrollment||||||
55619|NCT01257880|Secondary|Oxygen Desaturation Index|Measurement of number of times per hour blood oxygen saturation decreases by at least 4% during home sleep study.|Baseline||||||
55620|NCT01257880|Primary|Cognitive Function|Cognitive function will be assessed by a battery of performance-based neuropsychological tests.|Baseline||||||
55621|NCT01257880|Primary|Sleep Apnea, Number of Participants|An apnea-hypopnea index (AHI) >10 per hour during a home sleep study, defined as at least 5 hours of recorded data on the portable sleep monitor instrument for either the apnea-hypopnea index (AHI) or oxygen desaturation index (ODI) and at least 3 hours for the other index. The scale adopted for assessment of sleep apnea is as follows: AHI < 5, optimal; AHI 5-10, equivocal, participant may have sleep apnea; AHI >10, sleep apnea highly likely.|Following one night of a home sleep study|The analysis was based on per protocol.||participants|||Number
55622|NCT01257880|Primary|Platelet Activation|Platelet-poor plasma levels of sCD40L and P-selectin, and serum concentration of TXB2.|Baseline||||||
55623|NCT01257880|Primary|Cerebral Vasomotor Reactivity (VMR)|"The percentage change in basilar artery blood flow velocity from baseline between hypercapnia (increased blood CO2) and hypocapnia (decreased blood CO2), as measured by transcranial Doppler during a single testing period. This is calculated using the following equation:~VMR = 100 x (VelocityHYPERCAPNIA - VelocityHYPOCAPNIA) / VelocityBASELINE"|Baseline|||Percentage change||Standard Deviation|Mean
55624|NCT01257880|Primary|Embolic Tracks|Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver|Baseline||||||
55625|NCT01257750|Secondary|Corneal Vessel Length|Change in Vessel Length: defined as the mean measurement of the extent of vessels from end to end.|12 Weeks||||||
55626|NCT01257750|Secondary|Corneal Invasion Area|Change in invasion area: measuring the fraction of the total corneal area invaded by the vessels.|12 Weeks||||||
55627|NCT01257750|Secondary|Corneal Vessel Caliber|Change in vessel caliber: measuring the mean diameter of the corneal vessels.|12 Weeks||||||
55631|NCT01257581|Secondary|ATLIS Upper Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percentages of predicted normal strength||95% Confidence Interval|Mean
55632|NCT01257581|Secondary|Accurate Test of Limb Isometric Strength (ATLIS) Lower Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percentages of predicted normal strength||95% Confidence Interval|Mean
55633|NCT01257581|Secondary|HHD Upper % Baseline|The HHD % baseline measures are mean percent change for shoulder flexion, elbow extension, elbow flexion, wrist extension, and first dorsal interosseous muscles from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percent change||95% Confidence Interval|Mean
55634|NCT01257581|Secondary|HHD Upper Z-score|The HHD upper z-scores are means of z-scores for right and left shoulder flexion, elbow extension, elbow flexion, write extension and first dorsal interosseous muscles with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Z-score||95% Confidence Interval|Mean
55635|NCT01257581|Secondary|HHD Lower % Baseline|HHD % baseline measures are mean percent change for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||percent change||95% Confidence Interval|Mean
55636|NCT01257581|Secondary|Hand Held Dynamometry (HHD) Lower Z-score|The HHD lower z-scores are means of z-scores for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Z-score||95% Confidence Interval|Mean
55637|NCT01257581|Secondary|Lab Abnormal Reports by Treatment Assignment|The safety data is summarized according to treatment arm. Total number of Adverse Events (AEs), AEs that cause study drug withdrawal and abnormal laboratory tests are compared among treatment arms. A lab abnormality was a result that was out of range and considered clinically significant by the site investigator.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Events|||Number
55638|NCT01257581|Secondary|Dose Adjustments|These events were due to a double-blinded study design.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Number of Events due to Adverse Events|||Number
55639|NCT01257581|Secondary|Tracheostomy-free Survival|Secondary efficacy will be assessed by analyzing rate of tracheostomy-free survival at nine months.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||proportion of participants||95% Confidence Interval|Number
55640|NCT01257581|Secondary|Vital Capacity/Pulmonary Function Testing|Secondary efficacy will be assessed by analyzing the change in the Slow Vital Capacity score over nine months. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percentage of predicted normal.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||Percentage of predicted max value||95% Confidence Interval|Mean
55641|NCT01257581|Primary|Change in ALS Functional Rating Scale - Revised (ALSFRS-R)|Primary efficacy will be assessed by analyzing the mean rate of decline in the ALS Functional Rating Scale-Revised (ALSFRS-R) score over nine months. The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|38 weeks of treatment followed by a telephone interview at 42 weeks.|||scores on a scale||95% Confidence Interval|Mean
55642|NCT01257542|Secondary|Participants' Global Assessment of Cough: Relief From Cough|Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question “From when you woke up this morning until now, how much better is your cough?” where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
55643|NCT01257542|Secondary|Participants' Global Assessment of Cough: Cough Severity|"Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question  How much have you coughed in the past 6 hours?” where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot."|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
55644|NCT01257542|Secondary|Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
55645|NCT01257542|Secondary|Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period|Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hour post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
59246|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|16 weeks||||||
55646|NCT01257542|Secondary|Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
55647|NCT01257542|Secondary|Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period|Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Units on a scale||Standard Deviation|Mean
55648|NCT01257542|Primary|Total Cough Count|Total cough count was done by trained assessors using continuous digital video and audio recordings.|Up to 6 hours post-dose|Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.||Cough counts||Standard Deviation|Mean
55649|NCT01257503|Secondary|Overall Symptom Severity|Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up|10 days|Data analyzed on participant who completed 7-10 day follow-up and had valid cold scores. Data also analyzed twice daily on those participants who returned symptom diaries including: day 1 (153, 148), day 2 (146,138), and day 3 (136, 126). For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale||Standard Deviation|Mean
55650|NCT01257503|Secondary|Health Status|Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up|10 days|Health status on those with follow-up data and a valid score for health status. Health status also assessed in participants who returned symptom diaries including 152 on day 1, 142 on day 2 and 132 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale||Standard Deviation|Mean
55651|NCT01257503|Secondary|Functional Status|Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.|10 days|Participants who completed follow-up and had valid data for functional outcome. Data on functional status analyzed on days 1-3 for participants who returned symptom diaries including 145 on day 1, 142 on day 2 and 130 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale||Standard Deviation|Mean
55652|NCT01257503|Secondary|Change in Non-specific Symptoms|Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in irritability assessed after 510 doses, lethargy 414, fussiness 501, appetite 618. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale|Participants|Standard Deviation|Mean
55653|NCT01257503|Primary|Change in Severity of Cold Symptoms|Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after a dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in runny nose assessed after 819 doses, sneeze 456 doses, cough 772 doses, congestion 845. For category title, first n= homeopathic cold remedy, second n= placebo.||units on a scale|Participants|Standard Deviation|Mean
55654|NCT01257438|Secondary|Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions.|Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success.|6 months|||% of subjects with successful PLP||95% Confidence Interval|Number
55655|NCT01257438|Primary|Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.|Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.|30 days|Safety rates measured for the randomized subjects population (both AV Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.||% of subjects free from safety events||95% Confidence Interval|Number
59247|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|14 weeks||||||
55656|NCT01257438|Primary|Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months.|Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.|6 months|Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).||% of subjects with successful ACPP||95% Confidence Interval|Number
55657|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||days||95% Confidence Interval|Median
55658|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||days||95% Confidence Interval|Median
55659|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||log(ng/mL)||Standard Deviation|Mean
55660|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Raw Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).||ng/mL||Standard Deviation|Mean
55661|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|85, 87, 113, 141 and 169 days post-dose|95 patients (IM: 47 patients, SC: 48 patients) received a second injection of the study drug.||log(ng*day/mL)||Standard Deviation|Mean
55662|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|||log(ng*day/mL)||Standard Deviation|Mean
55663|NCT01257425|Primary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).|Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose|Analysed from ITT population.||log(ng*day/mL)||Standard Deviation|Mean
55664|NCT01257230|Secondary|Time to First Asthma Exacerbation During the 48 Week Treatment Period|The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|Week 48|FAS||Participants|||Number
55665|NCT01257230|Secondary|Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period|The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values. A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required treatment with systemic corticosteroid for at least 3 days.|48 weeks|FAS||Participants|||Number
55666|NCT01257230|Secondary|ACQ6 Responders|"Responder rates based on the ACQ6 after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)~The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS||percentage of participants|||Number
55667|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ6|"Change from baseline in AQC6 score at week 24.~The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS||units on a scale||Standard Error|Mean
55668|NCT01257230|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS||percentage of participants|||Number
59248|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|8 weeks||||||
55669|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 24.~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score was calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS||Units on a scale||Standard Error|Mean
55670|NCT01257230|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS||Number of puffs of rescue medication||Standard Error|Mean
55671|NCT01257230|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS||Number of puffs of rescue medication||Standard Error|Mean
55672|NCT01257230|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and Week 24|FAS||Number of puffs of rescue medication||Standard Error|Mean
55673|NCT01257230|Secondary|FEF25-75 Change From Baseline|"Change from baseline in mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75%), also known as maximum mid-expiratory flow, at individual time points after 24 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres per second||Standard Error|Mean
55674|NCT01257230|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0–3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
55675|NCT01257230|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0–3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
55676|NCT01257230|Secondary|Trough FVC Change From Baseline|"Change from baseline of Trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 24 weeks of treatment.~The measured values presented are actually adjusted means.."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
55677|NCT01257230|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 h after administration of trial medication (FVC peak0–3h) after 24 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
55678|NCT01257230|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 24.~The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
55679|NCT01257230|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24.~Note, the measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set (FAS) was the same as the treated set which included all randomised patients who were dispensed trial medication and received at least one documents dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.||Litres||Standard Error|Mean
55680|NCT01256658|Secondary|Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50|"Cumulative number of asymptomatic carriers having Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) from Week 1 to Week 50, was measured from group of participants diagnosed as asymptomatic carriers at Community Screening Campaign (CSC1)/Day1. Number of participants affected before and after diagnosed with ≥1 symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) (complicated and uncomplicated episodes combined). Number of SMRC5000s was detected by Rapid Diagnostic Test (RDT) using a blood sample from each participant and later confirmed to have a parasite density > or = 5000/uL by microscopy.~Week (1-2) indicates day1 to day14, week (3-4) indicates day 15 to day 28, week (5-6) indicates day 29 to day 42, etc. After first diagnosis of asymptomatic carriers at CSC1/Day1."|Week 1 to Week 50|Individual subject data from eligible randomized participants from Community Screening Campaign 1 (CSC1) for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and available form analysis and census data was obtained as per protocol.||participants|||Number
55725|NCT01256424|Secondary|Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|HPV response was defined as clearance of baseline HPV infection, asssessed by genotype|3 months after treatment|Patients with CIN2 at baseline, based on central histology read, and HPV positive at baseline||percentage of patients|||Number
59249|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|6 weeks||||||
55681|NCT01256658|Secondary|Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined|Number of asymptomatic carriers diagnosed with 1 Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000), 2 SMRC5000, 3 SMRC5000 and >3 SMRC5000 (complicated and uncomplicated episodes combined). Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.|12 months - period 1|Individual subject data from eligible clusters set defined as all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and census data was obtained as per protocol.||participants|||Number
55682|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) in asymptomatic carriers by study arm from all inhabitants diagnosed at any time for asymptomatic carriers. Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy."|12 months - period 1|The number of units represents the number of clusters that include all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) were collected and census data were obtained as per protocol.||percentage of participants|Participants|Standard Deviation|Mean
55683|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data|"Data is presented per cluster. Cluster data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in infants and children (>6 months and <5 years) was measured by Hemoglobin levels based on microscopy reading.~Mean and Standard Deviation (SD) percent were measured indicating the mean and SD of percentages of cluster frequencies under the study arm for that particular category."|Day 1 to day 28 - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Deviation|Mean
55684|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data|Individual data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 from Community Screening Campaign 1 (CSC1) infants and children (>6 months and <5 years). Hemoglobin levels were measured using the HemoCue® rapid test. This test was performed with a drop of blood collected from the fingertip at Day 1 and at Day 28.|Day 1 to Day 28- period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data was obtained as per protocol.||participants|||Number
55685|NCT01256658|Secondary|Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers|Percentage of microscopy-confirmed gametocyte asymptomatic carriers treated with COA566 for asymptomatic carriers in Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3).|Day 1, day 7 and day 28 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.||percentage of participants|||Number
55686|NCT01256658|Secondary|Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7|Percentage of participants with parasitological cure confirmed via microscopy at day 7 after treatment with COA566. This assessment was done on asymptomatic carriers from Community Screening Campaigns 1, 2 and 3 (CSC1, CSC2 and CSC3) from the intervention group only.|Day 7 of CSC1, CSC2 and CSC3 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.||percentage of participants|||Number
55687|NCT01256658|Secondary|Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)|"Data is presented per cluster. Hemoglobin levels at Community Screening Campaign 1 and 4 (CSC1 and CSC4) on day 1 per age group (5-9 years, 10-14 years, and ≥15 years) in the intervention versus the control arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all randomized participants (ages 5-9 years, 10-14 years, and ≥15 years) clusters for which CSC1 and CSC4 was conducted, data was available, and census data were obtained as per protocol.||g/dL|Participants|Standard Deviation|Mean
55688|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 4 (CSC4/Day 1) in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC4 was conducted, data was available, and census data was obtained as per protocol.||participants|||Number
55689|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 1 (CSC1)/Day 1 in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 (CSC1/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.||participants|||Number
55690|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1|Change in hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in infants and children (>6 Months and <5 Years) for asymptomatic carriers at CSC1 was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 and day 28 - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.||g/dL||Standard Deviation|Mean
55691|NCT01256658|Secondary|Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)|Number of gametocyte carriers at Community Screening Campaign 4 (CSC4) was measured via microscopy and confirmed using Quantitative Reverse Transcription PCR (qRT-PCR) at day 1 of CSC4.|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.||participants|||Number
55692|NCT01256658|Secondary|Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of gametocyte carriers at Day 1 for Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) was measured using gametocyte assessments (prevalence and density) via microscopy.~Mean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|Eligible clusters set consisted of all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Deviation|Mean
55693|NCT01256658|Secondary|Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of asymptomatic carriers from Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) was measured by confirmed positive microscopy for P. falciparum asexual forms in participants with absence of clinical signs and symptoms of malaria.~Mean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC 1, 2 3 and 4 was conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Deviation|Mean
55694|NCT01256658|Secondary|Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (infants and children (> 6 months and < 5 years)) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable carriers set consisted of all infants and children (> 6 months and < 5 years)) from intervention clusters confirmed positive for P. falciparum asexual forms at any CSC or when migrating into the cluster, who in the absence of clinical signs and symptoms received at least one dose of COA566 for the diagnosed asymptomatic infection.||participants|||Number
55695|NCT01256658|Secondary|Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable asymptomatic carriers set consisted of all consenting inhabitants from intervention clusters confirmed positive by RDT for P. falciparum asexual forms at any CSC or when migrating into the cluster, in the absence of clinical signs and symptoms who received at least one dose of COA566 to treat the diagnosed asymptomatic infection.||participants|||Number
55696|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)|"Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in post Community Screening Campaign (CSC), by study arm (individual level data) was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all subjects in post CSC. Person-year observed: sum of duration (in days) in post CSC for all subjects present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|12 months - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.||SMRC5000 per person-year|||Number
55697|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)|"Data is presented per cluster. Comparison of hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 in infants and children (>6 months and <5 years) by study arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized participants for which CSCs 1 and 4 were conducted, data was available, and census data were obtained as per protocol.||g/dL|Participants|Standard Deviation|Mean
55698|NCT01256658|Secondary|Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmation of asymptomatic carriers of P. falciparum at Community Screening Campaign 4 (CSC4) was conducted at month 12. Blood films were histologically treated and examined microscopically. When it was ascertained that P. falciparum was present, a count of the asexual forms against leukocytes was made using a tally counter."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.||participants|Participants|Standard Error|Mean
55780|NCT01255904|Primary|Time to Complete Study|Time from medication administration to study completion.|60-180 minutes|||Minutes||95% Confidence Interval|Median
55699|NCT01256658|Secondary|Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmed gametocyte carriers at Community Screening Campaign 4(CSC4) were assessed via microscopy at month 12 of period 1. Blood films were histologically treated and examined microscopically."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data were obtained as per protocol.||participants|Participants|Standard Error|Mean
55700|NCT01256658|Primary|Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)|"Data is presented per cluster. Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), > 6 months of age, at day 1 and at day 28."|Day 1 and day 28 of period 1|The number of units represents the number of clusters that include all randomized, > 6 months of age participants for which CSC1 was conducted, data was available and census data were obtained as per protocol.||g/dL|Participants|Standard Deviation|Mean
55701|NCT01256658|Primary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in infants and children (<5 years) in post Community Screening Campaign (CSC) at month 12 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all infants and children (<5 years) in post CSC.~Person-year observed: sum of duration (in days) for all infants and children (<5 years) in post CSC present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|Month 12 of period 1|The number of units represents the number of clusters that include all randomized infants and children (<5 years) for which CSCs 1, 2, and 3 were conducted, data was available, and census data were obtained as per protocol.||SMRC5000 per person-year|Participants|Standard Deviation|Mean
55702|NCT01256567|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab||Day 1 of Cycle 1 and 4 (cycle=21 days)|All participants with evaluable Vss data at the specified time points.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
55703|NCT01256567|Secondary|Clearance (Cl) of Ramucirumab|Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable clearance data at the specified time points.||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
55704|NCT01256567|Secondary|Half Life (t 1/2) of Ramucirumab||Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable t1/2 data at the specified time points.||days||Geometric Coefficient of Variation|Geometric Mean
55705|NCT01256567|Secondary|Area Under the Curve (AUC) of Ramucirumab|AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided.|Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable AUC data at the specified time points.||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
55706|NCT01256567|Secondary|Maximum Concentration (Cmax) of Ramucirumab|Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable Cmax data at the specified time points.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
55707|NCT01256567|Secondary|Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)|The number of participants with a positive anti-IMC-1121B titer at any point during the study.|Baseline up to data cut off (approximately 48.3 weeks)|All participants with evaluable antibody assessment data.||participants|||Number
55708|NCT01256567|Primary|Number of Participants With Adverse Events|Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.|Baseline up to data cut off (approximately 48.3 weeks)|All participants who received at least 1 dose of study drug.||participants|||Number
55709|NCT01256502|Secondary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points|Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|Stage 2 Surgery, Months 12, 18 and 24|Participants from the Full Analysis population (139 participants, 214 breasts), all enrolled participants who had SERI® Surgical Scaffold surgery/implant, with data at the given time-point.||units on a scale||Standard Deviation|Mean
55710|NCT01256502|Secondary|Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery|Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.|Immediately following Stage I surgery|Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery.||participants|||Number
55982|NCT01254214|Secondary|Center for Epidemiologic Studies Depression Scale (CESD)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|baseline, 8 weeks, 26 weeks|||units on a scale||Standard Deviation|Mean
55711|NCT01256502|Primary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months|The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|6 months|Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.||units on a scale||Standard Deviation|Mean
55712|NCT01256476|Primary|Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12||Baseline and 12 weeks|All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement.||percent||Standard Error|Mean
55713|NCT01256450|Secondary|Use of Rescue Medication|Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.|Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication||Tablets per day||Standard Deviation|Mean
55714|NCT01256450|Secondary|Change From Baseline to Week 12 in Investigator’s Overall Satisfaction With Study Drug|Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
55715|NCT01256450|Secondary|Change From Baseline to Week 12 in Subject’s Overall Satisfaction With Study Drug|Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
55716|NCT01256450|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication||units on a scale||Standard Deviation|Mean
55717|NCT01256450|Secondary|Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject’s satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
55718|NCT01256450|Secondary|Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale|Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
55719|NCT01256450|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||percentage of participants|||Number
55720|NCT01256450|Secondary|Number of Participants With Response to Treatment as Assessed by an NRS Scale|Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||participants|||Number
55721|NCT01256450|Secondary|Change From Baseline in Pain Intensity Over Time Using NRS Scale|Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
55722|NCT01256450|Primary|Change in Pain Intensity From Baseline to Week 12|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on Intent-to-Treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication.||units on a scale||Standard Deviation|Mean
55723|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 9 Months After First Treatment|Response was defined as absence of HSIL, and absence of oncogenic HPF if LSIL|9 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.||percentage of participants|||Number
55724|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment.|Response was defined as absence of HSIL, and absence of oncogenic HPV if LSIL.|6 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.||percentage of participants|||Number
58289|NCT01227785|Primary|Clinical Performance at1-month for LV Pacing Threshold|LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.|1-month|73 CRT-D patients had data available at 1-month visit.||volts (V)||Standard Deviation|Mean
55726|NCT01256424|Primary|Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.|3 months after last treatment|Patients with CIN2 at baseline, based on central histology review||percentage of patients|||Number
55727|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||Participants|||Number
55728|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||Participants|||Number
55729|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||mmHg||Standard Deviation|Mean
55730|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.||mmHg||Standard Deviation|Mean
55731|NCT01256411|Primary|Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)|Participants were monitored throughout the study for adverse events, serious adverse events and deaths.|Baseline to 12 months|Actual extension treatment received: The participants are included in each treatment group for which they received treatment. For example, if a participant started on LCZ696 200 mg but was then down-titrated to LCZ696 100 mg, the participant was counted once in the LCZ696 100 mg group and once in the LCZ696 200 mg group.||Participants|||Number
55732|NCT01256385|Secondary|Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B.|Assessed according to RECIST|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
55733|NCT01256385|Secondary|PFS of Myofibroblast (+) Cohort||From start of treatment to time of progression or death of any cause, assessed up to 5 years|Myofibroblast status was not determined. Concerns about the validity/technical feasibility as well as availability of the assay led us to decide to not perform the assay. We do not intend to perform this assay anymore.|||||
55734|NCT01256385|Secondary|Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST|Percentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
55735|NCT01256385|Secondary|Grade 3 or Higher Hematological Toxicity|Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
55736|NCT01256385|Secondary|PFS vs. Historical Control Cohort|PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%|From start of treatment to time of progression or death of any cause, assessed at 4 months|Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.||percentage of participants||90% Confidence Interval|Number
55737|NCT01256385|Secondary|Overall Response Rates (OR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Statistics reported are for Overall Response (OR) = CR + PR.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
55738|NCT01256385|Secondary|Overall Survival (OS)|Time from randomization until death from any cause|Up to 5 years|||days||95% Confidence Interval|Median
55739|NCT01256385|Primary|Progression-free Survival (PFS)|Progression determined using RECIST criteria: >=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.|From start of treatment to time of progression or death from any cause, assessed up to 5 years|||days||95% Confidence Interval|Median
55740|NCT01256294|Primary|Dose-normalized Maximum Plasma Drug Concentration (Cmax) at Steady State|Maximum (peak) plasma drug concentration after drug administration at steady state (after 14 days of treatment with each study drug). Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor.|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.||ng/mL/mg||95% Confidence Interval|Geometric Mean
55741|NCT01256294|Secondary|Number of Participants With Reported Biopsy Proven Acute Rejection Episodes||28 Days|Full analysis set.||participants|||Number
75042|NCT01056718|Secondary|Stress Heart Rate||10 Week|||Beats per Minute||Standard Deviation|Mean
55742|NCT01256294|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. An SAE was an event which: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; required or prolonged inpatient hospitalization; was medically significant, i.e., an event that jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|28 Days|Safety set||participants|||Number
55743|NCT01256294|Secondary|Trough Plasma Drug Concentration (C0) at Steady State|Trough plasma drug concentration measured prior to drug administration at steady state (after 14 days of treatment with each study drug).|Days 14 and 28: predose|PK analysis set, where data were available.||ng/mL||Standard Deviation|Mean
55744|NCT01256294|Secondary|Intra-patient Variability of Tacrolimus Pharmacokinetic Parameters|The intra-patient variability of tacrolimus pharmacokinetics of each formulation was evaluated by comparing AUC0-12h, maximum drug concentration (Cmax) and trough drug concentration (C0) at Days 7 and 14, and Days 21 and 28. Intra-patient variability was assessed by a calculation of the coefficient of variation, by patient, using the repeated measurements within each Period, where the coefficient of variation (%) = standard deviation/mean*100.|Days 7 and 14, and Days 21 and 28.|PK Analysis set.||percent coefficient of variation||Standard Error|Mean
55745|NCT01256294|Primary|Dose-Normalized Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) at Steady State|"Dose-normalized area under the concentration-time curve from time 0 to 12 hours (AUC0-12h) at steady state after 14 days of treatment with each study drug.~Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor."|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.||ng*hr/mL/mg||95% Confidence Interval|Geometric Mean
55746|NCT01256281|Primary|Pain Score in Legs (0-10)|"Pain score in legs at 2-4 hours after intervention will be the primary outcome.~Data analysis not done."|2-4 hours after intervention||||||
55747|NCT01256190|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes|||participants|||Number
55748|NCT01256190|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes|||participants|||Number
55749|NCT01256190|Secondary|Incidence of Hemostasis at 5 Minutes|Number of subjects in each group that achieved hemostasis at pre-specified times after treatment|5 minutes|||participants|||Number
55750|NCT01256190|Secondary|Safety|Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS)|28 days|All subjects treated were analyzed for safety. There were 39 subjects treated with Fibrocaps and 16 treated with gelatin sponge only, since 1 gel sponge subject was randomized but not treated.||participants|||Number
55751|NCT01256190|Primary|Time to Hemostasis|Time from application of treatment to cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis||minutes||Standard Deviation|Mean
55752|NCT01256177|Secondary|Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)|The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease.|After 8 weeks of start of treatment|Full Analysis Set||Participants|||Number
55753|NCT01256177|Secondary|Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation|MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114)||Scores on a scale||Standard Error|Least Squares Mean
55754|NCT01256177|Secondary|The Proportion of Patients at Week 8 With a Clinical Global Impression – Bipolar - Change (CGI-BP-C) of “Much” or “Very Much” Improved|Clinical Global Impression - Bipolar - Change (CGI-BP-C) of “much” or “Very much” improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved.|After 8 weeks of start of treatment|Full Analysis Set||Participants|||Number
55755|NCT01256177|Secondary|Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar – Severity (CGI-BP-S)|CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease|Baseline to Week 8|Full Anlaysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=112)||Scores on a scale||Standard Error|Least Squares Mean
55756|NCT01256177|Secondary|Change From Baseline to Week 8 in HAM-D Total Scores|HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114).||Scores on a scale||Standard Error|Least Squares Mean
55757|NCT01256177|Secondary|Change From Baseline to Each Assessment in MADRS Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe.|Baseline to Week 8|Full Analysis Set (Number of participants at each assessment : Baseline (Placebo=140, Quetiapine XR= 139), Week 1 (Placebo=140, Quetiapine XR= 139), Week 2 (Placebo=127, Quetiapine XR= 128), Week 4 (Placebo=114, Quetiapine XR= 120), Week 6 (Placebo=102, Quetiapine XR= 114), Week 8 (Placebo=100, Quetiapine XR= 114)).||Scores on a scale||Standard Error|Least Squares Mean
55758|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12|After 8 week of start of treatment|Full Analysis Set||Participants|||Number
55983|NCT01254214|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|baseline, 8 weeks, 26 weeks|||units on a scale||Standard Deviation|Mean
55759|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline|8 weeks from baseline|Full Analysis set||Participants|||Number
55760|NCT01256177|Primary|Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114)||Scores on a scale||Standard Error|Least Squares Mean
55761|NCT01256164|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes|||participants|||Number
55762|NCT01256164|Secondary|Number of Participants Achieving Hemostasis at 5 Minutes||5 minutes|||participants|||Number
55763|NCT01256164|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes|||participants|||Number
55764|NCT01256164|Secondary|Safety|Number of participants with Adverse events and clinically-significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the TBS|28 Days|All subjects treated were analyzed for safety.||participants|||Number
55765|NCT01256164|Primary|Mean Time to Hemostasis (TTH)|Time to hemostasis recorded from the first application of study treatment until cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis||minutes||Standard Deviation|Mean
55766|NCT01256086|Primary|PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)|The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.|60 min after application of study medication|Per Protocol Population||mg/ml||Geometric Coefficient of Variation|Geometric Mean
55767|NCT01256060|Other Pre-specified|Measures of Social Function - The Clinical Global Impressions - Social Scale (Baseline to Week 12)|"Social Function~a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale)."|12 Weeks|||participants|||Number
55768|NCT01256060|Other Pre-specified|Changes in Measures of Social Cognition, Social Function, Repetitive Behaviors, and Anxiety (Baseline to Week 12)|"Social Cognition (higher score=positive response)~Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100)~Eyes Test (0-28)~Strange Stories (0-16)~Irony and Empathy (0-24)~Social Function~Aberrant Behavior Checklist (0-48) (lower score=positive response)~Behavioral Assessment System for Children (higher score=positive response); i. Social: age 8 to 11 & 15 to 18 (18-69); age 12 to 14 (21-70); ii. Functional: age 8 to 14 (10-66); age 15 to 18 (10-64)~Social Responsiveness Scale (higher score=positive response); male (34-127); female (35-142)~Anxiety (lower score=positive response)~a. Child Symptom Inventory; i. Separation: male (44-106); female (44-101); ii. Generalized: male (40-101); female (41-96)~Repetitive Behaviors (lower score=positive response)~Child Yale-Brown Obsessive-Compulsive Scale (0-20)~Repetitive Behavior Scale (0-129)~Measures insensitive to change will be omitted from results."|12 Weeks|||units on a scale||95% Confidence Interval|Mean
55769|NCT01256060|Secondary|Blood Levels of Oxytocin During the Trial in Relation to Safety or Treatment Response|Children and adolescents with minimal changes in plasma level of oxytocin after treatment will be less responsive to treatment. Children and adolescents with atypical patterns of increase in oxytocin may be more sensitive to dose-related tolerability.|12 Weeks||12/2016||||
55770|NCT01256060|Secondary|Baseline Levels of Oxytocin in Relation to Either Safety or Treatment Response|Children and adolescents with lower plasma oxytocin levels at baseline will show treatment related changes in social cognition. Children and adolescents with higher oxytocin plasma levels will show diminished or less dramatic treatment responses and may have more difficulty tolerating the treatment.|12 Weeks||12/2016||||
55771|NCT01256060|Primary|Number of Participants With Serious Adverse Events|This will be reported as the number of participants who experienced a serious advert event throughout the study.|24 Weeks|||participants|||Number
55772|NCT01256060|Primary|Maximum Tolerated Dose (MTD)|The hypothesis is that the maximum tolerated dose in a range of 0.2-0.4 IU/kg / dose will be 0.4 IU/kg / dose, as was the case in the adult study, given that oxytocin is not stored in body fat and does not depend on liver or renal clearance.|12 Weeks|||IU / kg|||Number
55773|NCT01256034|Secondary|Plasma IL-6, CRP, Th1/Th2 Balance||14 days||||||
55774|NCT01256034|Primary|Postoperative Infectious Complication||30 days|||participants|||Number
55775|NCT01256008|Secondary|Functional Assessment of Cancer Treatment (FACT-B)|"The scale is used to assess the life quality of patients.~The scale includes 5 subscales. The scores of each scale are summed to compute a total score.~The scale range is 0-144. Higher score indicates better life quality.~The scale was assessed at baseline,4 week,12 week,24 week."|baseline, 4w,12w,24w|||units on a scale||Standard Deviation|Mean
55776|NCT01256008|Secondary|Athens Insomnia Scale(AIS)|"The scale is used to assess the sleep quality of patients.~The scale range of AIS is 0-21. Higher score indicates worse sleep quality.~The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline, 4w,8w,12w,24w|||units on a scale||Standard Deviation|Mean
55777|NCT01256008|Primary|Hamilton Anxiety Scale (HAMA-14)|"The scale(HAMA-14) is used to assessed the anxiety symptoms of patients.~The scale range is 0-56.Higher value represents a worse outcome.~The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week."|baseline,2 w,4 w,8 w,12 w,16 w,24 w|||units on a scale||Standard Deviation|Mean
55778|NCT01256008|Secondary|Visual Analogue Scale (VAS)|"The scale is used to assess the pain intensity of patients.~The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain.~The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline,4 w,8 w,12 w,24 w|||units on a scale||Standard Deviation|Mean
55779|NCT01256008|Primary|Hamilton Depression Rating Scale (HAMD-17)|"The scale(HAMD-17) is used to assessed the depression symptoms of patients.~The scale range is 0-53.Higher value represents a worse outcome.~The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week"|baseline,2 w,4 w,8 w,12 w,16 w,24 w|||units on a scale||Standard Deviation|Mean
75043|NCT01056718|Secondary|Resting Heart Rate||10 Week|||Beats per Minute||Standard Deviation|Mean
55781|NCT01255787|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
55782|NCT01255787|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
55783|NCT01255787|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||percentage of participants|||Number
55784|NCT01255787|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.||percentage of participants|||Number
55785|NCT01255787|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set included all randomized participants who received at least 1 dose of study drug. One patient in the placebo arm was excluded from all datasets due to enrollment in another clinical study. Only participants with Baseline and at least 1 post-baseline value are included. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
55786|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
55787|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with hired outside help||Standard Deviation|Mean
55788|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Activity days missed||Standard Deviation|Mean
55789|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with reduced household work||Standard Deviation|Mean
55790|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with no household work||Standard Deviation|Mean
55791|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
56039|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 4|Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
55792|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Work days with reduced work productivity||Standard Deviation|Mean
55793|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Number of work days missed in last month||Standard Deviation|Mean
55794|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
55795|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with hired outside help||Standard Deviation|Mean
55796|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Activity days missed||Standard Deviation|Mean
55797|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with reduced household work||Standard Deviation|Mean
55798|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Days with no household work||Standard Deviation|Mean
55799|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||units on a scale||Standard Deviation|Mean
55800|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Work days with reduced work productivity||Standard Deviation|Mean
55801|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.||Number of work days missed in last month||Standard Deviation|Mean
55802|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55803|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
56040|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 4|Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
55804|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55805|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55806|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55807|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55808|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55809|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55810|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55826|NCT01255722|Secondary|Average Signal-to-Noise Ratio (Average SNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments, in the ascending aorta and in the left ventricle and was expressed in Hounsfield Unit (HU). Measurements were set in post-injection images for the 6 territories.~A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.~Signal-to-Noise Ratios (SNR) of post-injection images were derived in all territories from attenuation measurements according to the following formula:~SNR Territory = Post Attenuation / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
55811|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55812|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55813|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of subjects|||Number
55814|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
55815|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
55816|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
55817|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
55818|NCT01255761|Secondary|Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52|"The DAS28(ESR) score is a measure of the subject's disease activity.~DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
55887|NCT01254747|Primary|Average Daily Wear Time|Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Hours||Standard Deviation|Mean
55819|NCT01255761|Secondary|Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12|"The DAS28(ESR) score is a measure of the subject's disease activity.~DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.||units on a scale||Standard Deviation|Mean
55820|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
55821|NCT01255761|Secondary|Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|"The measurement only includes subjects that were responders at Week 12, and this is the denominator for the percentages.~The Full Analysis Set (FAS)-Nonresponse imputation (NRI) population set was used for this analysis."||percentage of participants|||Number
55822|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
55823|NCT01255761|Primary|Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
55824|NCT01255761|Primary|Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined.~RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient’s global status."|Baseline (Week 0) to Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).||percentage of participants|||Number
55825|NCT01255722|Secondary|Average Contrast-to-noise Ratio (Average CNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments in the ascending aorta and the in left ventricle and expressed in Hounsfield Unit (HU).~A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.~In territories where pre and post signal attenuation measures were both available, the contrast-to-noise ratio was computed according to the following formula: CNR = (Post Att – Baseline Att) / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
59250|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|16 weeks||||||
55827|NCT01255722|Secondary|Average Signal Attenuation After IV Injection of Contrast|Attenuation of signal was measured off-site on post-injection images of four coronary segments, in the ascending aorta and in the left ventricle, then it was averaged at the patient level.|<1h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Hounsfield Units||Standard Deviation|Geometric Mean
55828|NCT01255722|Secondary|Coronary Track Rate|A post processing software automatically tracked the number of distal segments of the left anterior descending coronary artery, the left circumflex coronary artery and the right coronary artery . The number of segments tracked per patient were assessed by an independent off-site radiologist.|<24h|Full Analysis Set population: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Number of tracked segments per patient||Standard Deviation|Mean
55829|NCT01255722|Secondary|Average Image Quality According to Off-site Reading|For each patient, all 18 coronary segments were graded for image quality using a 5-point evaluation scale (from 0=non-diagnostic to 4=excellent). The average image quality was evaluated using the off-site readings, by averaging the scores obtained for the 18 segments used to determine the CT evaluability (primary criteria).|<24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Image quality Score on a scale||Standard Deviation|Mean
55830|NCT01255722|Primary|Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment|"Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic.~A patient’s CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0."|< 24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.||Percentage of patients||Standard Error|Geometric Mean
55831|NCT01255631|Secondary|Narcotic Pain Medications|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed.|Post-Operative Period|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs.|||||
55832|NCT01255631|Secondary|Lymphedema|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.|||||
55833|NCT01255631|Secondary|Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables due to lack of post-clinical assessment data and poor patient compliance with the 14 day mark follow up.|||||
55834|NCT01255631|Secondary|Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms.|||||
55835|NCT01255631|Secondary|Jackson Pratt (JP) Drain Output|Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study.|Post-Operative Day 1 & 2 (2 Days)|For the 7 patients who completed the study, the mean and standard deviations for the total JP drain output (in milliliters - mL) from post-operative days 1 & 2 (2 days total) were analyzed as a secondary outcome.||milliliters (mL)||Standard Deviation|Mean
55836|NCT01255631|Primary|Pain Level on Visual Analog Scale|Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).|2 weeks|Only 7 patients completed the study by quantifying the level of their pain post-operatively on a visual analog scale from 0-10. The medication logs and two week post-op analogs could not be utilized for the analysis since all 7 patients did not complete these logs.||units on a scale||Standard Deviation|Mean
56041|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4|Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
55837|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55838|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55839|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55840|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55841|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55842|NCT01255592|Secondary|Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55843|NCT01255592|Secondary|Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55844|NCT01255592|Secondary|Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55845|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55846|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55847|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
58290|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Threshold|LV pacing threshold results were reported at pre-discharge for CRT-D patients.|pre-discharge|75 patients had data available at pre-discharge||volts (V)||Standard Deviation|Mean
55848|NCT01255592|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55849|NCT01255592|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55850|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55851|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55852|NCT01255592|Secondary|Change From Baseline Total and Domain Scores in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)|"SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:~Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status)."|Baseline and end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
55853|NCT01255592|Secondary|Change From Baseline for the Symptom Scores of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
55854|NCT01255592|Secondary|Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||L/min||Standard Error|Least Squares Mean
55855|NCT01255592|Secondary|Transition Dyspnea Index (TDI) at End of Treatment (Day 28)|TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
55856|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters/second||Standard Error|Least Squares Mean
59251|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|2 weeks||||||
55857|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
55858|NCT01255592|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
55859|NCT01255592|Secondary|Change From Baseline in Slow Vital Capacity (SVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
55860|NCT01255592|Secondary|Change From Baseline in Weight of 24-hour Sputum Collection|Patients collected all sputum produced during a 24-hour period at baseline and Day 28.|Baseline and end of treatment (Day 28)|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||grams||Standard Error|Least Squares Mean
55861|NCT01255592|Secondary|Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55862|NCT01255592|Primary|Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).||ratio||90% Confidence Interval|Least Squares Mean
55863|NCT01255449|Secondary|Post-HSCT Changes in Lung Tissue Density|Changes in lung tissue density were measured by quantitative computed tomography(CT) scan 2 weeks before and 2 months after HSCT|Before and 2 months after HSCT|CT scans, in a format suitable for software analysis, were available in 8 patients only||g/mL||Standard Deviation|Mean
55864|NCT01255449|Primary|Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC)|2 weeks before and 2 months after HSCT|||1/cmH2O*s||Standard Deviation|Mean
55865|NCT01255436|Secondary|Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks|The percentage of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg at the end of 12 weeks|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.||percentage of participants|||Number
55866|NCT01255436|Secondary|Medication Adherence Rate|The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire at the end of 12 weeks Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.||percentage of participants|||Number
55867|NCT01255436|Primary|Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks|Absolute change in diastolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only patients who completed follow up and had evaluable data were analyzed.||mmHg||Standard Deviation|Mean
55868|NCT01255436|Primary|Mean Absolute Change in Systolic Blood Pressure After 12 Weeks|Absolute change in systolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only participants who completed follow up and had evaluable data were analyzed.||mmHg||Standard Deviation|Mean
55869|NCT01255423|Secondary|Ankle Joint Function|"Ankle joint function score (Karlsson Scoring scale which ranges from 0 worst possible score to 90 best possible score)at 24 and 72 hours and 7 days."|24 and 72 hours, 7 days|||Total score||Standard Deviation|Mean
55870|NCT01255423|Secondary|Tenderness|Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.|Change from baseline at 24 and 72 hours, 7 days|||N/cm^2||Standard Deviation|Mean
55871|NCT01255423|Secondary|Onset of Pain Relief|Onset of perceptible pain relief|Day 1|||Hour||Inter-Quartile Range|Median
55872|NCT01255423|Secondary|Pain on Movement|"Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|24 hours and 7 days|||mm||Standard Deviation|Mean
55873|NCT01255423|Primary|Pain on Movement|"Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|72 hours|||mm||Standard Deviation|Mean
59252|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|2 weeks||||||
55874|NCT01255306|Secondary|Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade|To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.|6 months|We included all patients who completed follow up visits and who had valid OCT measurements as defined per protocol.||micrometer|Participants|Standard Deviation|Mean
55875|NCT01255306|Primary|Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography|Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade.|6 months|We included all patients that have completed necessary follow up visits and have had optical coherence tomography measurements at all visits in the final analysis.||micrometer|Participants|Standard Deviation|Mean
55876|NCT01254890|Secondary|Phase II: Number of Participants With Response|Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of <5% blasts in the bone marrow (BM), with >1 X 10^9/L neutrophils and >100 x 10^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of >/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.|90 days|Nine participants were not evaluable for response.||participants|||Number
55877|NCT01254890|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine|MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine|28 day cycle|||mg/twice daily|||Number
55878|NCT01254851|Primary|Number of Steps Taken in 24 Hours.|The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.|1 day|The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized.||Steps||Full Range|Median
55879|NCT01254760|Secondary|Overall Fit|Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|Day 5, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale|Participants|Standard Deviation|Mean
55880|NCT01254760|Primary|Overall Vision|Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
55881|NCT01254760|Primary|Handling at Removal|Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
55882|NCT01254760|Primary|End of Day Dryness|End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
55883|NCT01254760|Primary|End of Day Comfort|End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
55884|NCT01254747|Secondary|Overall Satisfaction|Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
55885|NCT01254747|Secondary|Corrected Visual Acuity|Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||logMAR|Participants|Standard Deviation|Mean
55886|NCT01254747|Secondary|Lens Fit|Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale|Participants|Standard Deviation|Mean
58291|NCT01227785|Primary|Clinical Performance at Implant for LV Pacing Threshold|LV pacing threshold results were reported for CRT-D patients at implant.|implant|78 CRT-D patients had data available at implant.||volts (V)||Standard Deviation|Mean
55888|NCT01254747|Primary|Dryness Throughout the Day|Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
55889|NCT01254747|Primary|Overall Handling|Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
55890|NCT01254747|Primary|Vision Quality During the Day|Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
55891|NCT01254747|Primary|Overall Comfort|Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a scale||Standard Deviation|Mean
55892|NCT01254721|Primary|The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29|The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.|From Baseline to Day 29|||scores on the scale||Standard Deviation|Mean
55893|NCT01254721|Secondary|The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)|The Severity of Illness scale (CGI-S) is scored to rate the patient’s current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is “Normal, not at all ill” and a score of 7 indicates that a patient is “Among the most extremely ill patients”.|From Baseline to Day 29|||scores on the scale||Standard Deviation|Mean
55894|NCT01254669|Secondary|The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.|post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)|1 hour after intervention|The number of participants for analysis was determined based on the total enrolled and who responded to knowledge questions||units on a scale||Standard Deviation|Mean
55895|NCT01254669|Primary|The Receipt of the First HPV Vaccination|Receipt of the first HPV vaccination among adolescent daughters of the participants|within 1 month of randomization|The number of participants for analysis was determined based on number of participants enrolled and who answered questions of interest.||percentage of participants|||Number
55896|NCT01254656|Secondary|Virology Analysis Participant Accountability From Week 96 Through Study Termination|Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. “protocol-defined treatment failure” was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. “Treatment failure”: treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. “NRTI or NNRTI resistance mutations”: nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society–USA (IAS-USA) RAM guidelines; 4. ‘with result’ meant an analyzed sample returned genotypic result or phenotypic result or both.|Week 96 through study termination|The virology analysis set included only evaluable participants i.e. those having samples with valid genotypic or phenotypic susceptibility testing results and HIV-1 RNA >500 copies/mL. However, samples with observed emergence of resistance-associated mutations and HIV-1 RNA level ≤500 copies/mL or missing HIV-1 RNA level, were also noted.||Participants|||Number
55897|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.||Percentage||Standard Deviation|Mean
55898|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented, as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.||cells/uL||Standard Deviation|Mean
55899|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. LOCF was used to impute missing values.||Percentage||Standard Deviation|Mean
55900|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. Last observation carried forward (LOCF) was used to impute missing values.||cells/uL||Standard Deviation|Mean
55901|NCT01254656|Secondary|Number of Participants With Plasma HIV‑1 RNA Level <50 Copies/mL up to Week 208|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.|Up to Week 208|Analyses included all enrolled participants. Last visit used the last available visit of each participant. Discontinued from study, lost to follow-up, or missing HIV-1 RNA level data at last visit were considered to have HIV-1 RNA levels >=50 copies/mL. Participants discontinued due to program termination were not considered as discontinuations.||Participants|||Number
55902|NCT01254656|Primary|Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV‑1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses.||Participants|||Number
55903|NCT01254643|Secondary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.||milli Merck units/mL||95% Confidence Interval|Geometric Mean
55904|NCT01254643|Primary|Percentage of Participants With a Vaccine-related AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” to the study drug is defined as a vaccine-related AE.|up to 15 days after any vaccination|Safety Population, which consists of all participants who received at least one vaccination and had available follow-up data.||Percentage of Participants|||Number
55905|NCT01254643|Primary|Percentage of Participants With a Non-Injection Site (Systemic) AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.||Percentage of Participants|||Number
55906|NCT01254643|Primary|Percentage of Participants With an Injection-site Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.||Percentage of Participants|||Number
55907|NCT01254643|Primary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.||Percentage of Participants||95% Confidence Interval|Number
55908|NCT01254604|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.|Up to Week 4|APaT population||participants|||Number
55909|NCT01254604|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.|Up to 14 days after Week 4 visit|APaT population||participants|||Number
55928|NCT01254396|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.||hrs||Full Range|Median
55929|NCT01254396|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
55910|NCT01254604|Secondary|Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye|IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one “study eye” was identified for data summarization and analysis. The “study eye” was the eye with the higher (i.e., “worse”) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the “study eye.” Percent reduction in IOP at Week 4 = ([baseline IOP value − Week 4 IOP value]/Baseline IOP value)*100.|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint||participants|||Number
55911|NCT01254604|Primary|Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye|IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one “study eye” was identified for data summarization and analysis for this primary efficacy outcome measure. The “study eye” was the eye with the higher (i.e., “worse”) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the “study eye.” Change from baseline in IOP at Week 4 = Week 4 IOP value − baseline IOP value.|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint||mmHg||95% Confidence Interval|Least Squares Mean
55912|NCT01254409|Secondary|SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline|St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.|Day 1 (Baseline) and Day 57|||units on a scale||Standard Deviation|Mean
55913|NCT01254409|Secondary|6MWT (6 Minute Walk Test) Distance Walked Change From Baseline|Change from baseline (measured during screening period) in distance walked during a 6 minute walk test|Screening (between Day -35 and Day 1) and Day 57|||meters||Standard Deviation|Mean
55914|NCT01254409|Secondary|FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline||Day 1 (Baseline) and Day 57|||Absolute change in FEV1 % predicted||Standard Deviation|Mean
55915|NCT01254409|Secondary|DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline||Day 1 (Baseline) and Day 57|||Absolute change in % predicted DLCO||Standard Deviation|Mean
55916|NCT01254409|Secondary|FVC (Forced Vital Capacity) % Predicted Change From Baseline||Day 1 (Baseline) and Day 57|||absolute change in % predicted FVC||Standard Deviation|Mean
55917|NCT01254409|Secondary|FVC (Forced Vital Capacity) Change From Baseline to Day 57||Change from Day 1 (Baseline) to Day 57|||liters||Standard Deviation|Mean
55918|NCT01254409|Secondary|Vss|Volume of Distribution at Steady State|Day 15|||mL/kg||Full Range|Mean
55919|NCT01254409|Secondary|Total Body Clearance||Day 15|||ml/hr/kg||Full Range|Mean
55920|NCT01254409|Secondary|Terminal Elimination Half Life||Day 15|||hour||Full Range|Mean
55921|NCT01254409|Secondary|AUC48|Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.|Day 15|||µg*hr/mL||Standard Deviation|Mean
55922|NCT01254409|Secondary|Tmax|Time of Maximum observed concentration|Day 15|||hours||Standard Deviation|Mean
55923|NCT01254409|Secondary|Cmax|Maximum concentration|Day 15|Subjects who received all doses of study treatment||µg/mL||Standard Deviation|Mean
55924|NCT01254409|Primary|Safety and Tolerability|Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events|From first dose on Day 1 through Day 57|All subjects who received at least one dose of study treatment||participants|||Number
55925|NCT01254396|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||hrs||Standard Deviation|Mean
55926|NCT01254396|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
55927|NCT01254396|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Geometric Mean
56042|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
55930|NCT01254344|Secondary|Percentage of Participants With Favorable Clinical Response|Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection|4 weeks posttreatment|Population analyzed was participants who had no signs or symptoms of infection at the surgical site and did not require surgical intervention for infection.||percentage of participants||95% Confidence Interval|Number
55931|NCT01254344|Primary|Percentage of Participants With Success of Prophylaxis|Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy|From study drug dose (day of surgery) up to 4 weeks post therapy|"Primary analysis results are for evaluable-patients-only, defined as patients who received a complete dose of prophylaxis, underwent elective colorectal surgery with completion of bowel preparation procedure, had primary skin closure of the wound, and did not receive any prohibited systemic antibiotics or other prohibited anti-infective agents."||percentage of participants||95% Confidence Interval|Number
55932|NCT01254331|Secondary|Number of Participants Who Discontinued Tocilizumab||Week 52|Safety population||participants|||Number
55933|NCT01254331|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death||Baseline, every 4 weeks through Week 52|Safety population||percentage of participants|||Number
55934|NCT01254331|Secondary|Percentage of Participants Experiencing Fatigue||Baseline and Weeks 4, 8, 12, 16, 20, and 24|Safety population; n=number of participants analyzed for the given parameter at the specified visit||percentage of participants|||Number
55935|NCT01254331|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Levels|ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm/hour||95% Confidence Interval|Mean
55936|NCT01254331|Secondary|Mean C-Reactive Protein (CRP) Levels|CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L).|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mg/L||95% Confidence Interval|Mean
55937|NCT01254331|Secondary|Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)|Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||units on a scale||95% Confidence Interval|Mean
55938|NCT01254331|Secondary|Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm||95% Confidence Interval|Mean
55939|NCT01254331|Secondary|Assessment of Global Disease by the Participant Using VAS|"The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm||95% Confidence Interval|Mean
55940|NCT01254331|Secondary|Assessment of Pain by the Participant Using Visual Analog Scale (VAS)|"The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to their level of pain and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||mm||95% Confidence Interval|Mean
55941|NCT01254331|Secondary|SJC and TJC|28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.||joints||95% Confidence Interval|Mean
55942|NCT01254331|Secondary|Time To Achieve ACR20/ACR50/ACR70|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population||weeks||Inter-Quartile Range|Median
55943|NCT01254331|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population||percentage of participants|||Number
58336|NCT01227629|Secondary|Thromboembolic Events: Number of Participants Who Died|Occurence of death by all causes|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
55944|NCT01254331|Secondary|Percentage of Participants Achieving Remission Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit||percentage of participants|||Number
55945|NCT01254331|Secondary|Percentage of Participants Achieving LDA Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit||percentage of participants|||Number
55946|NCT01254331|Secondary|Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)|DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤) 3.2 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; number (n)= number of participants analyzed at a specific visit||percentage of participants|||Number
55947|NCT01254318|Secondary|Percentage of Participants With Invasive Fungal Infections in Canada|Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.|||||
55948|NCT01254318|Secondary|Percentage of Participants With a Specific Fungal Pathogen at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.|365 days|All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.||Percentage of participants|||Number
55949|NCT01254318|Primary|Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.||Percentage of participants||95% Confidence Interval|Number
55950|NCT01254305|Primary|Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score|The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient’s current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.~The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."||units on a scale||Standard Deviation|Mean
55951|NCT01254305|Secondary|Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward|The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems—with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).|From Baseline to Week 8|The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.||units on a scale||Standard Deviation|Mean
55952|NCT01254305|Primary|Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score|The CGI-S is a clinician-rated scale that rates the severity of the patient’s current state of fatigue based on the Investigator’s clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.~The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."||units on a scale||Standard Deviation|Mean
55953|NCT01254292|Other Pre-specified|Participants’ Evaluation of Pain During IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)||Participants|||Number
55954|NCT01254292|Other Pre-specified|Investigator's Evaluation of IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)||Participants|||Number
55955|NCT01254292|Other Pre-specified|Participants’ Evaluation of Pain During Successful IUS Insertion Procedure||Up to 18 months|Full analysis set||Participants|||Number
55956|NCT01254292|Other Pre-specified|Investigator's Evaluation of Successful IUS Insertion Procedure||Up to 18 months|Full analysis set||Participants|||Number
56043|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
55957|NCT01254292|Other Pre-specified|Cumulative Number of Participants With Partial or Total Expulsion|Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.|Up to 18, 24, 36 months|Full analysis set||Participants|||Number
55958|NCT01254292|Secondary|Compliance Rate for Yasmin Pill Intake||Up to 18 months|Full analysis set||Percentage of participants|||Number
55959|NCT01254292|Secondary|Pearl Index (PI)|The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.|Up to 18, 24, 36 months|Full analysis set||Pregnancies per 100 women years||95% Confidence Interval|Mean
55960|NCT01254292|Secondary|Cumulative Drop-out Rate|The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.|Up to 6, 12, 18, 24 and 36 months|Full analysis set||Percentage of participants|||Number
55961|NCT01254292|Secondary|EVAPIL-R Scores at 18 Months/EOS|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated)||Scores on a scale||Standard Deviation|Mean
55962|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)||Scores on a scale||Standard Deviation|Mean
55963|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)||Scores on a scale||Standard Deviation|Mean
55964|NCT01254292|Secondary|EVAPIL-R Scores at 6 Months|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 6 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)||Scores on a scale||Standard Deviation|Mean
55965|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)||Scores on a scale||Standard Deviation|Mean
55966|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)||Scores on a scale||Standard Deviation|Mean
55967|NCT01254292|Secondary|User Satisfaction – Rating of Usual Menstrual Pain Intensity|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
55968|NCT01254292|Secondary|User Satisfaction – Comparison of Menstrual Pain Intensity Between Now and Before Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
59253|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|2 weeks||||||
55969|NCT01254292|Secondary|User Satisfaction – Satisfaction With Menstrual Bleeding Absence|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
55970|NCT01254292|Secondary|User Satisfaction – Frequency of Experiencing Unexpected Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
55971|NCT01254292|Secondary|User Satisfaction – Satisfaction With Menstrual Bleeding Pattern|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
55972|NCT01254292|Secondary|User Satisfaction – Amount of Menstrual Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
55973|NCT01254292|Secondary|User Satisfaction – Choices Upon Completion of the Study|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
55974|NCT01254292|Secondary|User Satisfaction – Acceptability of the Administration of Study Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)||Participants|||Number
55975|NCT01254292|Secondary|Overall Satisfaction Rate at 12 Months (LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)||Percentage of participants|||Number
55976|NCT01254292|Secondary|Overall Satisfaction Rate at 6 Months (LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)||Percentage of participants|||Number
55977|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.~The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase."|At 18 months/EOS|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)||Percentage of participants|||Number
55978|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 18 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 18 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)||Percentage of participants|||Number
55979|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 12 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)||Percentage of participants|||Number
55980|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 6 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)||Percentage of participants|||Number
55981|NCT01254292|Primary|Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 18 months|Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)||Percentage of participants|||Number
75044|NCT01056718|Secondary|Peak Stress Diastolic BP||10 Week|||mm Hg||Standard Deviation|Mean
55984|NCT01254214|Secondary|SF-12 PCS|Physical component summary score (PCS) of the SF-12 is a self-reported measure of physical health-related quality of life.Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired physical health quality or function.|baseline, 8 weeks, 26 weeks|||T scores||Standard Deviation|Mean
55985|NCT01254214|Secondary|Short Form -12 MCS|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|baseline, 8 and 26 weeks|||T-Scores||Standard Deviation|Mean
55986|NCT01254214|Primary|State-Trait Anxiety Inventory|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|Baseline, 8 weeks, 26 weeks|||units on a scale||Standard Deviation|Mean
55987|NCT01254188|Secondary|Kaplan-Meier Estimates of Failure-free Survival|Time to event (months) = (date of event or censoring – date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.|3,6,9,12,15,18,21,and 24 months|FAS||percentage probability||95% Confidence Interval|Number
55988|NCT01254188|Secondary|Kaplan-Meier Estimates of Progression-free Survival|PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.|3,6,9,12,15,18,21,and 24 months|FAS||percentage probability||95% Confidence Interval|Number
55989|NCT01254188|Secondary|Overall Survival|OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|3, 6, 9, 12, 15, 18, 21, 24 Months|||percentage probability||95% Confidence Interval|Number
55990|NCT01254188|Secondary|Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.|"* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.~Duration of first CCyR (months) = (date of CCyR loss or censoring – date of first CCyR +1) / 30.4375"|6,12,18 and 24 months|||percentage of participants||95% Confidence Interval|Number
55991|NCT01254188|Secondary|Complete Cytogenetic Response|Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.|6 months|||percentage of participants||95% Confidence Interval|Number
55992|NCT01254188|Secondary|Duration of Major Molecular Response|Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) – date of first MMR + 1) / 30.4375|3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected|Full Analysis set, Number of events / censored 29/312.||percentage of participants||95% Confidence Interval|Number
55993|NCT01254188|Secondary|Time to Molecular Response at 24 Months|Estimated median time to first MMR by Kaplan-Meier method|24 months|Full analysis set||Months||95% Confidence Interval|Median
55994|NCT01254188|Primary|The Percentage of Patients Achieving MMR by 12 Months|MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method|12 months|||percentage of participants||95% Confidence Interval|Number
55995|NCT01254045|Secondary|Salivary Cortisol|salivary cortisol level measured immediately before social challenge task and 20 minutes following social challenge task at each time point (i.e., baseline, week 2, and week 3)|baseline, week 2, and week 3|||nmol/L||Standard Error|Mean
55996|NCT01254045|Primary|Eye Contact/Gaze During 10 Minute Social Challenge Task|Number of times that eye gaze occurred (i.e., participant looked at female experimenter in the eyes) during 10 minute social challenge task (first 5 minutes social proximity, second 5 minutes social interaction). The social challenge task occurred 50 minutes after internasal dose (of placebo, placebo + oxytocin, or oxytocin) at baseline, week 2, and week 3 visits.|baseline, week 2, and week 3|||eye contact/gaze events per 10 minutes||Standard Error|Mean
55997|NCT01253980|Primary|Treatment Failure|A treatment failure was a patient who at any time deteriorated necessitating a change to the treatment regimen. This was determined by assessing reported symptoms (cough, shortness of breath, wheeze and fever) and comparing clinical signs (respiratory rate, oxygen saturation, wheeze, flaring, grunting, recessions, crepitations, temperature, mental status) to signs at presentation.|At routine follow-up 3 and 5 days post-ingestion or earlier if necessary|per protocol||participants||95% Confidence Interval|Number
55998|NCT01253902|Secondary|Mean Tear Break Up Time (TBUT) at Week 12|Tear Break Up Time was analyzed using the average of the readings of both eyes. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.||Seconds||Standard Deviation|Mean
55999|NCT01253902|Secondary|Mean Corneal Staining With Fluorescein at Week 12|Corneal staining was analyzed using the average of the scores of both eyes. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (>20 puncta) and 3=Severe (too many puncta to count).|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.||Score on a scale||Standard Deviation|Mean
56000|NCT01253902|Primary|Mean Conjunctival Hyperemia at Week 12|Conjunctival hyperemia was analyzed using the average of the scores of both eyes. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).|Week 12|Intent-to-treat population (ITT) included all participants who were randomized to study medication.||Score on a scale||Standard Deviation|Mean
75045|NCT01056718|Secondary|Peak Stress Systolic BP||10 Week|||mm Hg||Standard Deviation|Mean
56001|NCT01253824|Secondary|Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||mIU･day/mL||Standard Deviation|Mean
56002|NCT01253824|Primary|Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||ng･day/mL||Standard Deviation|Mean
56003|NCT01253824|Secondary|Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||mIU･day/mL||Standard Deviation|Mean
56004|NCT01253824|Primary|Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles|||pg･day/mL,||Standard Deviation|Mean
56005|NCT01253811|Secondary|Rate (Number Per Subject Year) of All Bleeding Episodes Requiring Treatment With a FXIII Containing Product Other Than Recombinant Factor XIII.|The rate (number per subject year) of all spontaneous, traumatic and intracranial bleeding episodes requiring treatment with FXIII-containing products during the rFXIII treatment period was assessed for treatment period.|Weeks 0 to end of trial visit (week 173).|There were no bleeding episodes requiring treatment with a haemostatic agent (rFXIII) during the trial, which included subjects from full analysis set who received at least one dose of the trial product.|||||
56006|NCT01253811|Secondary|Vital Signs: Pulse|Values collected for pulse from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis included all subjects who received at least one dose of the trial product.||beats/minute||Standard Deviation|Mean
56007|NCT01253811|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values collected for diastolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set one dose of the trial product.||mmHg||Standard Deviation|Mean
56008|NCT01253811|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values collected for systolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmHg||Standard Deviation|Mean
56009|NCT01253811|Secondary|Physical Examinations|Number of subjects in percentage with changes in values of physical examinations from week 0 to end of trial visit were collected.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product. Two abnormal physical examination findings related to skin and musculo-skeletal system were assessed as clinically significant by the investigator during the trial.||percentage of subjects|||Number
56010|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haematocrit|Clinical laboratory values for haematocrit collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||percentage of red blood cells||Standard Deviation|Mean
56011|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Erythrocytes|Clinical laboratory values for erythrocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||10^12 cells/L||Standard Deviation|Mean
56012|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Thrombocytes|Clinical laboratory values for thrombocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||10^9 cells/L||Standard Deviation|Mean
56013|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Leucocytes|Clinical laboratory values for leucocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||10^9 cells/L||Standard Deviation|Mean
56014|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haemoglobin|Clinical values for haemoglobin collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmol/L||Standard Deviation|Mean
56015|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT)|Clinical laboratory assessments for ASAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||IU/L||Standard Deviation|Mean
56016|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT)|Clinical laboratory assessments for ALAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||IU/L||Standard Deviation|Mean
56017|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Urea|Clinical laboratory assessments for urea at week 24 to end ot trial visit.|Every 6th month, week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmol/L||Standard Deviation|Mean
56018|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Creatinine|Clinical laboratory assessments for creatinine at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.||mmol/L||Standard Deviation|Mean
56019|NCT01253811|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.|All subjects who received rFXIII were monitored for the frequency of development of anti-rFXIII antibodies. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors.|Week 0 to end of trial visit (week 173).|The SAS included all subjects who received at least one dose of the trial product. There were no antibodies against rFXIII detected in any patient during the trial.||percentage of subjects|||Number
56020|NCT01253811|Primary|Number of Treatment Emergent (Serious and Non-serious) Adverse Events|An adverse event was described as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (serious and non-serious), defined as adverse events occurring from first trial product administration to the end of the subject’s participation in the trial.|Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks.|The safety analysis set included all subjects who received at least one dose of the trial product.||number of events|||Number
56021|NCT01253577|Secondary|Percentage of Sinuses That Developed Frank Polyposis|Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30 days|All 105 subjects were present for this endpoint exam. However n=85 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.||percentage of sinuses||95% Confidence Interval|Mean
56022|NCT01253577|Primary|Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure|clinically significant IOP elevation is a change from baseline of >10 mm Hg on sinus side with drug-coated implant but not on side with control implant|90 days|Two patients did not have their ocular exam performed at day 90 (LTFU) but had ocular exams at earlier time points.||percentage of patients||95% Confidence Interval|Mean
56023|NCT01253577|Primary|Percentage of Sinuses Requiring Post-operative Intervention|Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30-days|All 105 subjects were present for the primary endpoint exam. However n=96 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.||percentage of sinuses||95% Confidence Interval|Mean
56024|NCT01253564|Secondary|Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status|Physician’s Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse). An improvement was classed as a difference from baseline of at least -1 point. Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit.|Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)|Safety population.||percentage of participants||95% Confidence Interval|Number
56025|NCT01253564|Secondary|Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain|VAS is a measure of pain intensity. The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale. The beginning of the line represented no pain and the end of the line represented maximum pain. Total score ranged from 0 - 100. Reported values are decrease in VAS of greater than (>) 20 mm or >30 mm from baseline.|Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)|Safety population. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
56026|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic|An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population||percentage of participants|||Number
56027|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids|An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. Percentage of participants and 95% Clopper-Pearson CI are reported.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.||percentage of participants||95% Confidence Interval|Number
56028|NCT01253564|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival. The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first. OS was calculated by Kaplan-Meier estimates.|From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)|Safety population.||months||95% Confidence Interval|Median
56029|NCT01253564|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason are reported.|Baseline up to end of the study and every 3 months during follow-up (up to 16 months)|Safety Population.||percentage of participants|||Number
56030|NCT01253564|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.||months||95% Confidence Interval|Median
56044|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 3|Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
56031|NCT01253564|Secondary|Percentage of Participants With Disease Progression or Death by Disease Site|Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.||percentage of participants|||Number
56032|NCT01253564|Secondary|Time to New Lesion by Disease Site|Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions. Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, ‘n’ signifies number of participants with measurable disease at baseline for specified category.||months||95% Confidence Interval|Median
56033|NCT01253564|Secondary|Duration of Stable Disease (SD) by Disease Site|Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause. SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category.||months||95% Confidence Interval|Median
56034|NCT01253564|Secondary|Time to Response by Disease Site|Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first). CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies number of participants with measurable disease for specified category.||months||95% Confidence Interval|Median
56035|NCT01253564|Secondary|Duration of Response by Disease Site|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR. CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)|Safety population. Here, 'n' signifies number of participants with best overall response of CR or PR for specified category.||months||95% Confidence Interval|Median
56036|NCT01253564|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site|Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1). CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Best overall response was calculated separately for brain, other sites (extracranial) and whole body. Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies the number of participants with measurable disease at baseline for specified category.||percentage of participants||95% Confidence Interval|Number
56037|NCT01253564|Primary|Percentage of Participants With Adverse Events (AEs)|AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.|From baseline up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.||percentage of participants|||Number
56038|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
75046|NCT01056718|Secondary|Diastolic BP||10 Week|||mm Hg||Standard Deviation|Mean
56046|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3|Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
56047|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.|||||
56048|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2|Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|Zero participants were analyzed.|||||
56049|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 2|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.||liters/hour (L/h)||Standard Deviation|Mean
56050|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 2|Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.||hours (h)||Full Range|Median
56051|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2|AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC 0-τ values.||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
56052|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2|Cmax after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
56053|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1|Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Vss values.||liters (L)||Standard Error|Mean
56054|NCT01253525|Secondary|Ramucirumab Clearance (CL) or Cycle 1|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.||liters/hour (L/h)||Standard Deviation|Mean
56055|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 1|Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.||hours (h)||Full Range|Median
56056|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1|AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC0-∞ values.||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
56057|NCT01253525|Secondary|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.|Cycle 1 through Cycle 5 (28-day cycles)|All enrolled participants who received at least 1 dose of study drug and were analyzed for anti-ramucirumab (IMC-1121B) antibodies.||percentage of participants|||Number
56058|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1|Cmax after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
56059|NCT01253525|Primary|Number of Participants With Serious Adverse Events (SAEs)|The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.||participants|||Number
56060|NCT01253525|Primary|Number of Participants With Adverse Events (AEs)|The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.||participants|||Number
56061|NCT01253525|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1|DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.|Cycle 1 of 28-day cycle|All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.||participants|||Number
56206|NCT01251952|Primary|Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.|After drug infusion, participants will be closely monitored for at least 4 hours for side effects|Up to 21 days post transplant||||||
56062|NCT01253447|Secondary|Maximum Percentage Change in Apoptosis|Peripheral blood AML cells (total 2 x 10^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response.|Baseline to 12 courses||||||
56063|NCT01253447|Primary|Treatment-related Non-hematological Toxicity|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)|Up to 30 days post-treatment||||||
56064|NCT01253447|Primary|Number of Participants With a Response of CR, CRp, or PR|Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count >/= 1.0 x10^9/L, Platelet count >/= 100 x10^9/L; Bone marrow aspirate and biopsy: </= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count >/=1.0 x10^9/L, Platelet count >/= 100 x10^9/L, >/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts </= 5% if Auer rods are present. Morphologic CR with incomplete count recovery (CRp): All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L).|12 weeks of treatment|No participant was not evaluable for response.||participants|||Number
56065|NCT01253408|Primary|Colonic Transit Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours|||units on a scale||Standard Deviation|Mean
56066|NCT01253408|Secondary|Gastric Emptying at 2 and 4 Hours|Proportion of stomach contents emptied at a 2 and 4 hours.|2, 4 hours|||proportion of stomach contents||Standard Deviation|Mean
56067|NCT01253408|Secondary|Ascending Colon Emptying T 1/2|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours after radiolabeled meal was ingested|||hours||Standard Deviation|Mean
56068|NCT01253408|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours after radiolabeled meal was ingested|||percentage of meal||Standard Deviation|Mean
56069|NCT01253408|Secondary|Gastric Emptying Half-Time (t1/2)|The time for half of the ingested solids or liquids to leave the stomach.|Approximately 2 hours after radiolabel meal is ingested|||minutes||Standard Deviation|Mean
56070|NCT01253408|Secondary|Colonic Transit Geometric Center|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|28, 32, and 48 hours|||units on a scale||Standard Deviation|Mean
56071|NCT01253369|Secondary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better objective response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.||proportion of patients||80% Confidence Interval|Number
56072|NCT01253369|Primary|8-Week Progression-Free Rate|The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions.|For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.||proportion of patients||80% Confidence Interval|Number
56073|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.||pg/mL||Standard Deviation|Mean
56202|NCT01251978|Primary|To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.||1 year|complications were only assessed in the high dose group||participant|||Number
56074|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.||ul/dL||Standard Deviation|Mean
56075|NCT01253304|Primary|Pharmacokinetics: Apparent Volume of Distribution (Vz/F)|The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
56076|NCT01253304|Primary|Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)|The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
56077|NCT01253304|Primary|Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)|The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||hours||Full Range|Geometric Mean
56078|NCT01253304|Primary|Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.||nanograms times hr/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
56079|NCT01253304|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||nanograms times hour/milliliter(ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
56080|NCT01253304|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.||hours||Full Range|Median
56081|NCT01253304|Primary|Pharmacokinetics: Maximum Observed Concentration (Cmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
56082|NCT01253265|Secondary|Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)|tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.||days||Full Range|Median
56083|NCT01253265|Secondary|Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)|Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
56084|NCT01253265|Secondary|Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)|AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.||micrograms•day per milliliter(μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
56085|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Lymphocyte Counts||Baseline, 26 weeks|All randomized participants.||10^9 cells per liter (GI/L)||Full Range|Median
56086|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Neutrophil Counts||Baseline, 26 weeks|All randomized participants.||10^9 cells per liter (GI/L)||Full Range|Median
56087|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).|Baseline, 16 weeks|All randomized participants.||percentage change in ESR||Full Range|Median
56088|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein|C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.|Baseline, 16 weeks|All randomized participants.||percentage change in C-Reactive Protein||Full Range|Median
56089|NCT01253265|Primary|Number of Participants With Clinically Significant Effects|Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline up to 26 weeks|All randomized participants.||participants|||Number
56090|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hours||Full Range|Median
56091|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hours||Full Range|Median
56207|NCT01251770|Secondary|IV Fluid Intake||12 hours from baseline|||ml||Standard Deviation|Mean
56092|NCT01253187|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng·h/mL||95% Confidence Interval|Geometric Mean
56093|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hours||Full Range|Median
56094|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol·h/L||95% Confidence Interval|Geometric Mean
56095|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
56096|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol·h/L||95% Confidence Interval|Geometric Mean
56097|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
56098|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng·h/mL||95% Confidence Interval|Geometric Mean
56099|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng/mL||95% Confidence Interval|Geometric Mean
56100|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg·h/mL||95% Confidence Interval|Geometric Mean
56101|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg/mL||95% Confidence Interval|Geometric Mean
56102|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hour||Full Range|Median
56103|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hour||95% Confidence Interval|Median
56208|NCT01251770|Primary|Change in Sodium Levels||Change from baseline in sodium level after 12 hours|||mEq/L||Standard Deviation|Mean
58909|NCT01220557|Secondary|CES-D Score|Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.|6 month follow up||||||
56104|NCT01253174|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng∙h/mL||95% Confidence Interval|Geometric Mean
56105|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||hour||Full Range|Median
56106|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol∙h/L||95% Confidence Interval|Geometric Mean
56107|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
56108|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol∙h/L||95% Confidence Interval|Geometric Mean
56109|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||nmol/L||95% Confidence Interval|Geometric Mean
56110|NCT01253174|Primary|Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng∙h/mL||95% Confidence Interval|Geometric Mean
56111|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||ng/mL||95% Confidence Interval|Geometric Mean
56112|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg∙h/mL||95% Confidence Interval|Geometric Mean
56113|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.||pg/mL||95% Confidence Interval|Geometric Mean
56114|NCT01253148|Secondary|Overall Response Rate (ORR)|Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all target and non-target lesions; no new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions.|End of post treatment follow-up period of up to 20 months|All participants||percentage of participants|||Number
56115|NCT01253148|Secondary|Median Overall Survival (OS)|OS is defined as the duration of time from enrollment to time of death from any cause.|Up to 36 months|All participants||months||95% Confidence Interval|Median
56137|NCT01252940|Secondary|Change From Baseline in Fasting HDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
84938|NCT00956943|Secondary|Side Effects|frequency of serious adverse events|8 weeks|intent to treat||events|||Number
56116|NCT01253148|Primary|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|End of post treatment follow-up period of 20 months|All participants||months||95% Confidence Interval|Median
56117|NCT01253135|Primary|Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed)|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. The primary efficacy endpoint was analyzed, using Kaplan-Meier survival analysis, to estimate the median time to wound closure over the 21-day treatment period. Any wound which did not heal by Day 21 was censored in the analysis.||days to closure||95% Confidence Interval|Median
56118|NCT01253135|Primary|Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed).|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. Inter-group comparison was done using a paired Prentice-Wilcoxon method, which is applicable to censored data.||days to wound closure||Standard Deviation|Mean
56119|NCT01253070|Secondary|Event-free Survival|Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death or relapse (up to 10 years)|||months||95% Confidence Interval|Median
56120|NCT01253070|Secondary|OS|OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Time from registration to death (up to 10 years)|||months||95% Confidence Interval|Median
56121|NCT01253070|Primary|Overall Survival (OS) Rate|Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.|1 year|Three participants withdrew consent to protocol treatment and follow-up prior to 1 year post registration (2 ITD; 1 TKD). These participants have been excluded from the primary endpoint analysis.||percentage of participants||95% Confidence Interval|Number
56122|NCT01253044|Secondary|Sheehan Disability Inventory|To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability.|Baseline and week 12|||units on a scale||Standard Deviation|Mean
56123|NCT01253044|Primary|Brief Symptom Inventory 18 (BSI-18)|To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.|Baseline and week 12|||T-score||Standard Deviation|Mean
56124|NCT01253018|Secondary|Stroke Impact Scale: Hand Subscale|The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.|Baseline, 12 week and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 12 and the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.||units on a scale||Standard Deviation|Mean
56125|NCT01253018|Secondary|Wolf Motor Function Test (WMFT)|The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.||seconds||Standard Deviation|Mean
56126|NCT01253018|Secondary|Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)||week 12|The severity of the patients enrolled in the study were such that TMS did not evoke the number of motor action potentials needed for analysis.|||||
56138|NCT01252940|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
56203|NCT01251952|Secondary|To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose.|During hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.|days 0 and 21 post autologous stem cell transplantation||||||
56127|NCT01253018|Primary|Fugl-Meyer Motor Upper Extremity Assessment|This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. 1 participant in each group did not return for retention and were not included in the retention analysis.||units on a scale||Standard Deviation|Mean
56128|NCT01252966|Secondary|Cognitive Performance (Attention)|Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at Baseline were excluded as outliers.||Change in number of commission errors||Standard Deviation|Mean
56129|NCT01252966|Secondary|Cognitive Performance (Response Inhibition)|"Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word PRESS in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change."|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.||Change in number of commission errors||Standard Deviation|Mean
56130|NCT01252966|Secondary|Cognitive Performance (Working Memory)|Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.||Change in maximum recall span||Standard Deviation|Mean
56131|NCT01252966|Secondary|Point-prevalence Abstinence at 6-month Follow-up|Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|6 month follow-up|||Percentage of participants|||Number
56132|NCT01252966|Primary|Point-prevalence Abstinence at End of Treatment|Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|End of treatment (Week 12)|||Percentage of participants|||Number
56133|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 48|"The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
56134|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 24|The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
56135|NCT01252940|Secondary|Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
56136|NCT01252940|Secondary|Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
56165|NCT01252277|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma.|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (AA); measured as percent of total fatty acid content in the phospholipid compartment of plasma.|baseline to end of intervention (~6 months)|Subjects completing intervention||ratio||Inter-Quartile Range|Median
56139|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 48 were analyzed.||mg/dL||Standard Deviation|Mean
56140|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 24|The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 24 were analyzed.||mg/dL||Standard Deviation|Mean
56141|NCT01252940|Secondary|Change From Baseline in CD4 Count Through Week 48|"The mean (SD) change in CD4 count was analyzed from baseline through Week 48.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 48 were analyzed.||cells/mm^3||Standard Deviation|Mean
56142|NCT01252940|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24|The mean (SD) change in CD4 count was analyzed from baseline through Week 24.|Baseline to Week 24|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 24 were analyzed.||cells/mm^3||Standard Deviation|Mean
56143|NCT01252940|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Week 48|Participants in the Full Analysis Set in the FTC/RPV/TDF and the Delayed Switch to FTC/RPV/TDF groups were analyzed.||percentage of participants|||Number
56144|NCT01252940|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set: participants who were randomized into the study and received at least one dose of study drug.||percentage of participants|||Number
56145|NCT01252810|Secondary|Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections|Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).|2, 6 and 24 hours post Ioforminol and Iopamidol adminstration|Summary of subjects with renal biomarker-based CI-AKI by time point (Per Protocol Population).||Subjects|||Number
56146|NCT01252810|Secondary|To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration|"To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.~To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.~Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects."|Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.|Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.||Number of events|||Number
56147|NCT01252810|Primary|Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.|Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.|After the imaging date for either Ioforminol or Iopamidol.|The measured values are looking at 1) Overall Image Quality and, 2) Diagnostic Usefulness.||Number of subjects|||Number
56148|NCT01252355|Other Pre-specified|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows: Alanine Aminotransferase (ALT) >3, 5 or 10 Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) >3, 5 or 10 ULN; Alkaline Phosphatase >1.5 ULN; Total Bilirubin (TB) >1.5 ULN; and ALT >3 ULN and TB >2 ULN.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population as previously defined but including only participants who had post-baseline values.||participants|||Number
56149|NCT01252355|Secondary|Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population: all randomized and treated participants. Participants were included in the treatment group according to the drug actually received.The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group.||participants|||Number
56150|NCT01252355|Secondary|Resource Utilization When Relapse|Resource utilization each time a participant experiences an MS relapse, specifically the number of hospitalizations, the number of over night spent in the hospital and number of intensive care admissions if hospitalized were to be reported.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
56151|NCT01252355|Secondary|Change From Baseline in Short Form Generic Health Survey - 36 Items, Version 2 (SF-36v2) Summary Scores at Week 24|SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
56152|NCT01252355|Secondary|Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
56166|NCT01252277|Secondary|Modulation of Ki-67 Expression|Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67|6 month value compared to baseline value|||Change in percent Ki-67 expression||Inter-Quartile Range|Median
59254|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|2 weeks||||||
56153|NCT01252355|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of no Relapse at Week 24, 48, and 72|Probability of no relapse at 24, 48 and 72 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse. Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time <=t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined.||percent probability of no relapse||95% Confidence Interval|Number
56154|NCT01252355|Secondary|Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, region, IFN-beta dose stratum, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 24|ITT population as previously defined but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
56155|NCT01252355|Secondary|Brain MRI Assessment: Volume of Gd-enhancing T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.||milliliters per scan|||Number
56156|NCT01252355|Secondary|Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. Probability of disability progression was to be estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.|||||
56157|NCT01252355|Secondary|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-beta dose stratum and baseline number of Gd-enhancing T1-lesions as covariates).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.||lesions per scan||95% Confidence Interval|Number
56158|NCT01252355|Primary|Annualized Relapse Rate (ARR) (Poisson Regression Estimates)|"ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-beta dose stratum, and number of relapses in the year prior to randomization as covariates)."|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||relapses per patient-year||95% Confidence Interval|Number
56159|NCT01252290|Secondary|Change in Ki-67 Expression|Immunocytochemical staining for Ki-67 antibody. Percent of 500 benign breast epithelial cells scored that are classified as positively staining.|6 month value compared to baseline value|||change in percent Ki-67 expression||Inter-Quartile Range|Median
56160|NCT01252290|Secondary|Change in Quality of Life|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. Summation score of degree of difficulty (scored 0 to 4 each) with 43 individual activities. Thus total score ranges from 0 to 172. Increasing score represents increasing problems with side effects.|Change from Baseline to Month 6|||units on a scale||Full Range|Median
56161|NCT01252290|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and AA (measured as percent of total fatty acid content) in the phospholipid compartment of plasma.|Change from Baseline to Month 6|||ratio||Inter-Quartile Range|Median
56162|NCT01252290|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value|||units on a scale||Inter-Quartile Range|Median
56163|NCT01252290|Primary|The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day|To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.|6 month visit|||proportion of enrolled participants|||Number
56164|NCT01252277|Secondary|Change in Quality of Life.|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.|duration of intervention, baseline to ~ 6 months|Subjects completing intervention||units on a scale||Inter-Quartile Range|Median
56187|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Fibrinogen|Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.|Baseline to Month 6|Per-protocol population||g/L||Standard Error|Least Squares Mean
56167|NCT01252277|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value|||change in units on a scale||Inter-Quartile Range|Median
56168|NCT01252277|Primary|The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day|The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.|6 month visit|||proportion of enrolled participants|||Number
56169|NCT01252238|Primary|Diastolic Function||12 weeks||||||
56170|NCT01252238|Primary|Aortic Compliance||12 weeks||||||
56171|NCT01252238|Primary|Change in Insulin Sensitivity by HOMA at 12 Weeks|The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value|12 weeks|||HOMA Scale||Standard Deviation|Mean
56172|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)||Baseline to Month 6|Per-protocol population with available data||mIU/L||Standard Error|Least Squares Mean
56173|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin||Baseline to Month 6|Per-protocol population with available data||nmol/L||Standard Error|Least Squares Mean
56174|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Cortisol||Baseline to Month 6|Per-protocol population||nmol/L||Standard Error|Least Squares Mean
56175|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)||Baseline top Month 6|Per-protocol population with available data||mIU/L||Standard Error|Least Squares Mean
56176|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)|Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.|Baseline to Month 6|Per-protocol population||ng/mL||Standard Error|Least Squares Mean
56177|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with activated protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56178|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Free Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with Protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56179|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Antigen|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% in adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56180|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Activity|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56181|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Antithrombin|"Antithrombin is a protein in the blood that naturally blocks blood clots from forming.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 80% to 130%.for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56182|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VIII|"Clotting factor VIII, also known as anti-hemophilic factor (AHF), functions in blood coagulation by stabilizing fibrin clots.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%.for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56183|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VII|"Clotting factor VII, also called proconvertin or autoprothrombin I, functions in blood coagulation.~Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults."|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56184|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor II|Clotting factor II, also called prothrombin, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.|Baseline to Month 6|Per-protocol population||percentage of normal||Standard Error|Least Squares Mean
56185|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)|Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.|Baseline to Month 6|Per-protocol population||µg/L||Standard Error|Least Squares Mean
56186|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasminogen|Plasminogen is the precursor of plasmin, which lyses fibrin clots.|Baseline to Month 6|Per-protocol population||g/L||Standard Error|Least Squares Mean
61769|NCT01191190|Secondary|IwCLL-WG Defined Stable Disease (SD)|Responses were assessed two months after completion of therapy|2 months|||participants|||Number
56188|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)|"This assay is based on measurement of the effect of activated protein C on the endogenous thrombin potential, the time integral of thrombin generation initiated in plasma through the extrinsic coagulation pathway.~The APC resistance assay measures the ratio of endogenous thrombin potential in the presence and absence of a standard amount of exogenous APC.~APC resistance is calculated as the ratio of EPT after APC addition over the EPT with no APC addition.~APC resistance is defined as a poor anticoagulant response of plasma to APC (less inhibition of thrombin formation) and a correspondingly higher ratio."|Baseline to Month 6|Per-protocol population||ratio||Standard Error|Least Squares Mean
56189|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)|"The APC resistance assay is a clotting test that measures the ratio of APTT clotting times in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of the clotting time after APC addition over the clotting time with no APC addition.~APC resistance is defined as a poor anticoagulant response of plasma to APC (minimal prolongation of the APTT) and a correspondingly low ratio."|Baseline to Month 6|Per-protocol population with available data||ratio||Standard Error|Least Squares Mean
56190|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex|The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population||ng/mL||Standard Error|Least Squares Mean
56191|NCT01252186|Secondary|Change From Baseline to End of Month 6 in D-dimer|D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population||ng/mL||Standard Error|Least Squares Mean
56192|NCT01252186|Primary|Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels|Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.|Baseline to Month 6|Per-Protocol (PP) Population included all data from ITT participants obtained prior to experiencing major protocol violations.||pmol/L||Standard Error|Least Squares Mean
56193|NCT01252147|Primary|Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Intra-rater (within raters) agreement of the GEA-J scores (1=minimum, 2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 rater who evaluated 68 subjects using GEA-J scale with photonumeric guide, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.||Kappa statistics||95% Confidence Interval|Number
56194|NCT01252147|Primary|Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Inter-rater agreement (among raters) of the GEA-J scores (1=minimum,2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters who scored 68 subjects’ eyelashes using GEA-J Scale with photonumeric guide at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kendall’s W is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.||Kendall's W||95% Confidence Interval|Number
56195|NCT01252134|Secondary|Corneal Staining Extent|Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.||percentage of cornea||Standard Deviation|Mean
56196|NCT01252134|Secondary|Corneal Staining Type|Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.||Units on a scale||Standard Deviation|Mean
56197|NCT01252134|Secondary|Subjective Comfort|Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.|8 hours|This reporting group includes all participants who completed the study.||Units on a scale||Standard Deviation|Mean
56198|NCT01252134|Primary|Ex Vivo Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.|8 hours|This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error.||degrees||Standard Deviation|Mean
56199|NCT01252095|Primary|Maximum Tolerated Dose (MTD) Based on DLT|The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.|Following first 1 month cycle|Patients had to complete cycle 1 per protocol.||DLTs|||Number
56200|NCT01251978|Secondary|Visual Acuity (LogMar)||12 months|||LogMar|||Number
56201|NCT01251978|Secondary|Tumor Thickness||baseline and 1 year|||millimeters (mm)||Full Range|Mean
56204|NCT01251952|Secondary|To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose.||days 0 and 21 post autologous stem cell transplantation||||||
56209|NCT01251757|Secondary|Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control|Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level <= 100 mg/dL.|12 months post randomization|All randomized participants who were taking a statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.||percentage with controlled LDL|||Number
56210|NCT01251757|Secondary|Post Intervention Low Density Lipoprotein (LDL) Level|We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.|12 months post randomization|All randomized participants who were taking statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.||mg/dL||Standard Deviation|Mean
56211|NCT01251757|Secondary|Percentage With Good (<140/90 mmHg) Blood Pressure Control|Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP <140 mmHg and a mean diastolic BP < 90 mmHg.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization and who had at least one post randomization BP recorded in the EMR. Missing data were not imputed.||percentage of subjects with good control|||Number
56212|NCT01251757|Secondary|Systolic Blood Pressure (SBP)|Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.|12-months post randomization|The analysis sample was restricted to ACEI/ARB users with at least one post intervention SBP measurement recorded in the EMR. We did not impute any missing data.||mm Hg||Standard Deviation|Mean
56213|NCT01251757|Secondary|Percentage With Good (>80%) ACEI/ARB Adherence|Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization||Percent with good adherence|||Number
56214|NCT01251757|Secondary|Percentage With Good (>80%) Statin Adherence|Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking statins at the time of randomization.||percent with good adherence|||Number
56215|NCT01251757|Primary|Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)|We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization||mMPR expressed as a fraction||Standard Deviation|Mean
56216|NCT01251757|Primary|Adherence to Statins|"We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days’ supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days’ supply that would extend beyond the end of the window.~We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications."|12 months post randomization|All randomized participants who were taking statins at the time of randomization||mMPR as a fraction||Standard Deviation|Mean
56217|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Docetaxel|Apparent volume of distribution at steady state (Vss) of Docetaxel.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||L||Geometric Coefficient of Variation|Geometric Mean
56218|NCT01251653|Secondary|Total Clearance (CL) of Docetaxel|Total Clearance (CL) of Docetaxel from plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||mL/min||Geometric Coefficient of Variation|Geometric Mean
56219|NCT01251653|Secondary|Cmax of Docetaxel|Maximum concentration of docetaxel in plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
56220|NCT01251653|Secondary|AUC 0-24 of Docetaxel|Area under the concentration-time curve of docetaxel in plasma over the time interval from 0 up to 24 hours|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
56221|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Gemcitabine|Apparent volume of distribution at steady state (Vss) of Gemcitabine.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||L||Geometric Coefficient of Variation|Geometric Mean
56222|NCT01251653|Secondary|Total Clearance (CL) of Gemcitabine|Total Clearance (CL) of Gemcitabine from plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||mL/min||Geometric Coefficient of Variation|Geometric Mean
56337|NCT01250730|Primary|Apparent Volume of Distribution (Vz/F) of Crizotinib|"Vz/F of crizotinib is obtained from a Dose / (AUCinf *kel).~Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||Liter||Standard Deviation|Geometric Mean
56223|NCT01251653|Secondary|Cmax of Gemcitabine|Maximum concentration of Gemcitabine in plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
56224|NCT01251653|Secondary|AUC 0-tz of Gemcitabine|Area under the concentration-time curve of Gemcitabine in plasma over the time interval from 0 up to the last quantifiable data point|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
56225|NCT01251653|Secondary|Cmax,ss of Afatinib|Maximum concentration of Afatinib in plasma at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
56226|NCT01251653|Secondary|Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib|Area under the concentration-time curve of Afatinib in plasma over a uniform dosing interval t at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
56227|NCT01251653|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first administration of study medication to the time of death from any cause.|From the first administration of study medication to the time of death|TS, MTD cohort||Weeks||Inter-Quartile Range|Median
56228|NCT01251653|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the first administration of study medication to the time of disease progression or death, whichever occurred first.|From the first administration of study medication to the time of disease progression or death|TS, MTD cohort||Weeks||Inter-Quartile Range|Median
56229|NCT01251653|Secondary|Duration of Disease Control According to RECIST v1.1|Duration of disease control according to RECIST v1.1.|From the first administration of study medication to the time of disease progression or death|TS for patients who experienced disease control.||Days||Standard Deviation|Mean
56230|NCT01251653|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was the time from the first documented complete response or partial response to disease progression or death.|From the first documented complete response or partial response to the time of disease progression or death|TS for patients who experienced objective response.||Days||Standard Deviation|Mean
56231|NCT01251653|Secondary|Time to Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Time to objective response is the time from the start of treatment to the date of first documented complete response or partial response. Descriptive analyses has been performed for the time to objective response (N(%) of patients with first occurrence of objective response at 6, 12 and 24 weeks). Onset of objective response is derived for patient with measurable disease.|6 weeks, 12 weeks and 24 weeks|TS||Participants|||Number
56232|NCT01251653|Secondary|Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
56233|NCT01251653|Secondary|Disease Control According to RECIST v1.1|Disease control according to RECIST v1.1 Disease control is complete response, partial response or stable disease for measurable patients and complete response or non−CR/non−PD for non−measurable patients. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
56234|NCT01251653|Secondary|Best Overall Response According to RECIST v1.1 Criteria|Best overall response (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) was the best response recorded at any time from the date of the first administration of afatinib or gemcitabine/docetaxel to the end of treatment (EOT). Partial response is for patients with measurable disease. Missing categories signifies that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
56235|NCT01251653|Secondary|The Incidence and Intensity of AEs With Grading According to CTCAE.|The incidence and intensity of adverse events with grading according to CTCAE. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first drug administration until 28 days after last drug administration, up to 717 days.|TS||Participants|||Number
56236|NCT01251653|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).|DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever >38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever >38.5º C or Grade ≥3 infection. 3. Platelet count of <25x 10^9/L or <50x 10^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0|3 weeks|Treated Set (TS)||Participants|||Number
56338|NCT01250730|Primary|Apparent Oral Clearance (CL/F) of Crizotinib|CL/F of crizotinib is obtained from a Dose per AUCinf.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||liter per hour||Standard Deviation|Geometric Mean
56237|NCT01251354|Secondary|Determination of Overall Survival in This Patient Population|Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.|2 years after the last patient enrolled|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
56238|NCT01251354|Secondary|Determination of Duration of Response in This Patient Population|Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
56239|NCT01251354|Secondary|Determination of Overall Response Rate (ORR) in This Patient Population|Overall Response Rate (ORR): Defined as the sum of CR and PR.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
56240|NCT01251354|Secondary|Determination of Progression Free Survival (PFS) in This Patient Population|Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
56241|NCT01251354|Secondary|Determination of Time to Progression (TTP) in This Patient Population|Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
56242|NCT01251354|Secondary|Number of Participants With Adverse Events||Up to 28 days after last dose|All Screened Population||participants|||Number
56243|NCT01251354|Primary|Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)|"CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.~PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|12 weeks|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint|||||
56244|NCT01251315|Primary|Intracellular Glutathione Level|Mean intracellular glutathione level every 2 hour|6 hours|Intention-to-treat||µmol/L||Standard Deviation|Mean
56245|NCT01251315|Secondary|Augmentation Index|"Augmentation index (%) is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection if appropriate augmentation index has been shown to be a predictor of adverse cardiovascular events in a high risk patient populations,higher augmentation index is associated with target organ damage. Absolute change of augmentation index from baseline to 6 hours will be estimated for the analysis."|Baseline and 6 hours|||percentage of the central pulse pressure||Standard Deviation|Mean
56246|NCT01251146|Secondary|Number of Participants Compliant With Study Treatment|Participants compliant with study treatment were the participants who have completed the study treatment regimen.|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|ITT population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
56247|NCT01251146|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|Safety population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
56248|NCT01251146|Secondary|Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6|Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
56249|NCT01251146|Secondary|Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment|Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
56250|NCT01251146|Secondary|Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."||ratio||Standard Deviation|Mean
61770|NCT01191190|Primary|IwCLL-WG Defined Complete Response (CR)|Responses were assessed two months after completion of therapy|2 months|||participants|||Number
56251|NCT01251146|Secondary|Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."||millisecond square (ms^2)||Standard Deviation|Mean
56252|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure."||millisecond per millimeter of mercury||Standard Deviation|Mean
56253|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).|Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)|"Intention to treat (ITT) population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."||millisecond per millimeter of mercury||Standard Deviation|Mean
56254|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
56255|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
56256|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
56257|NCT01251120|Secondary|Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI)|The CDAI is a purely clinical index to measure disease activity. The index includes swollen and tender joint counts, participant global assessment of disease activity, and evaluator global assessment of disease activity (EGA).|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
56258|NCT01251120|Secondary|Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria|The ACR definition of response includes tender and swollen joint counts, VAS scales for pain, participant and investigator global assessment of disease activity, participant-assessed disability using Health Assessment Questionnaire (HAQ) and acute phase response.|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
56259|NCT01251120|Secondary|Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28|"The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. For this study ESR was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:~DAS28 = 0.56 × √(TJC) + 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant’s global assessment of disease activity (100-mm VAS). DAS28 ≤ 2.6 defined remission."|Month 6|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
58404|NCT01227421|Secondary|Influenza Antibody Response: Influenza A H3N2|Change in antibody titer for Influenza A H3N2|28 days|Members of the intensive virologic follow up group with laboratory confirmed influenza A H3N2||Fold change in antibody titer||Inter-Quartile Range|Median
56260|NCT01251120|Secondary|Number of Hours Absent From Work|Work productivity measures include absence from work (participant reported and registries), permanent work disability (pension, participant reported and registries), presenteeism (Quantity and Quality instrument, QQ).|Baseline and 6 and 12 months|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
56261|NCT01251120|Primary|Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:~DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant’s global assessment of disease activity (100-mm Visual Analog Scale [VAS]). DAS28 less than/equal to (≤) 2.6 defined remission."|Month 12|Because of the limited number (n) of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.|||||
56262|NCT01251042|Secondary|Frequency of Allogenic Blood Transfusion||Up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||percentage of participants|||Number
56263|NCT01251042|Secondary|Mean Blood Loss Volume|Estimated blood loss during and after surgery.|After surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||ml||Full Range|Mean
56264|NCT01251042|Secondary|Interferon Gamma (IFN-γ) Concentration|Systemic IFN-γ concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
56265|NCT01251042|Secondary|Tumor Necrosis Factor Alpha (TNF-α) Concentration|Systemic TNF-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
56266|NCT01251042|Secondary|Interleukin-10 (IL-10) Concentration|Systemic IL-10 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
56267|NCT01251042|Secondary|Interleukin-8 (IL-8) Concentration|Systemic IL-8 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
56268|NCT01251042|Secondary|Interleukin-6 (IL-6) Concentration|Systemic IL-6 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
56269|NCT01251042|Secondary|Interleukin-1-alpha (IL-1-α) Concentration|Systemic IL-1-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||pg/ml||Standard Deviation|Mean
56270|NCT01251042|Primary|Difference in Plasma Free Hemoglobin (p-Hb) Concentration|Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery|At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||g/l||Standard Deviation|Mean
56271|NCT01251042|Secondary|Creatinine Concentration|Systemic creatinine concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||μmol/l||Standard Deviation|Mean
56272|NCT01251042|Secondary|Potassium Concentration|Systemic potassium concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||mmol/l||Standard Deviation|Mean
56273|NCT01251042|Secondary|Hemoglobin Concentration|Systemic hemoglobin concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||g/dl||Standard Deviation|Mean
56274|NCT01251042|Secondary|Plasma Free Hemoglobin (p-Hb) Concentration|Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.||g/l||Standard Deviation|Mean
56275|NCT01250990|Primary|Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin|Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.|Baseline and 12 weeks|Of the 22 subjects enrolled, only subjects who completed the baseline and 12 week reverse cholesterol transport studies were included in the final outcome analysis.||%/mol/h||95% Confidence Interval|Mean
56276|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56277|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56577|NCT01247428|Secondary|Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)|240 days|||percentage of participants||95% Confidence Interval|Number
56278|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56279|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56280|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56281|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56282|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56283|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56284|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56285|NCT01250925|Secondary|Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events|The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.|Six weeks|Participants who completed the study visits were analyzed.||participants|eyes||Number
56286|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.||cells/mm2|eyes|Standard Error|Mean
56287|NCT01250899|Primary|Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.|Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.|12 weeks|After 12 weeks of oral vitamin D supplementation, serum 25(OH)D levels were measured in the Vitamin D Insufficient arm. 81% (n=66) of insufficient persons achieved 25(OH)D ≥30ng/mL (p=0.32 vs. historical controls).||percentage of participants||95% Confidence Interval|Number
56288|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
56289|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
56290|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity. The outcome is not available for this metabolite since the terminal elimination phase was not determinable.|Pre-dose to 56 hours post-dose|No participants were analyzed for this outcome measure since the terminal elimination phase was not determinable.|||||
56291|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
56292|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
56293|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
56294|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
56613|NCT01245647|Secondary|Risky Sexual Behaviors|Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.|4 months|||percentage of persons with risky sex|||Number
56295|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
56296|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
56297|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||units on a scale||95% Confidence Interval|Least Squares Mean
56298|NCT01250769|Secondary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||ug/mL||95% Confidence Interval|Least Squares Mean
56299|NCT01250769|Primary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.||ug/mL||95% Confidence Interval|Least Squares Mean
56300|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.||Percentage of participants|||Number
56301|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.||Percentage of participants|||Number
56302|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.||Percentage of participants|||Number
56303|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
56304|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
56305|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
56339|NCT01250730|Primary|Terminal Elimination Half-life (t1/2) of Crizotinib|"t1/2 of crizotinib is the time measured for the plasma concentration to decrease by one half. It is obtained from a Loge(2)/kel.~Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||hours||Standard Deviation|Mean
56340|NCT01250730|Primary|Time to Cmax (Tmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Full Range|Median
88083|NCT00928395|Secondary|Change in OAB-q and SF-36 Questionnaires.||every three months for 36 months||||||
56306|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||Percentage of participants|||Number
56307|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.||Percentage of participants|||Number
56308|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.||Percentage of participants|||Number
56309|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.||Percentage of participants|||Number
56310|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
56311|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
56312|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
56341|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Standard Deviation|Geometric Mean
58964|NCT01219933|Secondary|Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population||percentage of participants|||Number
56313|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||Percentage of participants|||Number
56314|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
56315|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
56316|NCT01250756|Secondary|Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose|Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Pre-toddler dose, 1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||Fold Rise||95% Confidence Interval|Geometric Mean
56317|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
56318|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
56319|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
56320|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
56321|NCT01250756|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
56322|NCT01250756|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
56323|NCT01250756|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
56324|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
56325|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series|Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
56326|NCT01250756|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
56327|NCT01250730|Primary|Metabolite to Parent Ratio Cmax|The metabolic ratio (MR) is calculated by first converting the Cmax for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ratio||Standard Deviation|Geometric Mean
56328|NCT01250730|Primary|Metabolite to Parent Ratio AUClast|The metabolic ratio (MR) is calculated by first converting the AUClast for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ratio||Standard Deviation|Geometric Mean
56329|NCT01250730|Primary|Metabolite to Parent Ratio AUC(0-inf)|The metabolic ratio (MR) is calculated by first converting the AUC(0-inf) for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ratio||Standard Deviation|Geometric Mean
56330|NCT01250730|Primary|Time to Cmax (Tmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Full Range|Median
56331|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Standard Deviation|Geometric Mean
56332|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Plasma Active Metabolite (PF-06260182)|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
56333|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUC0-inf) of Plasma Active Metabolite (PF-06260182)|"AUC(0-inf) of PF-06260182 is estimated from the PF-06260182 concentration. It is obtained from AUClast plus (Clast/kel).~AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.~Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
56334|NCT01250730|Primary|Dose Normalized Cmax of Crizotinib|Dose normalized (to 150 mg dose) Cmax is obtained from Cmax / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng/mL||Standard Deviation|Geometric Mean
56335|NCT01250730|Primary|Dose Normalized AUClast of Crizotinib|Dose normalized (to 150 mg dose) AUClast is obtained from AUClast / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
56336|NCT01250730|Primary|Dose Normalized AUC(0-inf) of Crizotinib|Dose normalized (to 150 mg dose) AUC(0-inf) is obtained from AUC(0-inf) / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
61771|NCT01191190|Secondary|IwCLL-WG Defined Partial Response (PR)|Responses were assessed two months after completion of therapy|2 months|||participants|||Number
56342|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Crizotinib|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
56343|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib|"AUC(0-inf) of crizotinib is estimated from the crizotinib concentration. It is obtained from AUClast plus (Clast/kel).~AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.~Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose|||ng*hr/mL||Standard Deviation|Geometric Mean
56344|NCT01250717|Primary|Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists|One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.|status post prostectomy|||participants|||Number
56345|NCT01250509|Secondary|Change in Psychological Stress (Baseline and 4 Months)|The 10-item Perceived Stress Scale was used to evaluate perception of stressful events over the past month by using a 5-point Likert scale (0 = never to 4 = very often) (Cohen et al., 1983). The mean of the ten items was used in analysis. Higher scores indicate greater perceived stress.|Change from Baseline in Psychological Stress|An intention-to-treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.||units on a scale||Standard Deviation|Mean
56346|NCT01250509|Secondary|Telomerase Activity|Cryopreserved peripheral blood nuclear cells (PBMCs) were thawed and live cells counted using a hemocytometer by the Trypan blue exclusion method. For each sample, an extract of 5000 cells per microliter was made and two concentrations, corresponding to 5000 and 10,000 cells, were assayed for each sample to ensure the assay was in the linear range. Telomerase activity was assayed by the Telomerase Repeat Amplification Protocol (TRAP) using a commercial kit (TRAPeze, Telomerase Detection kit, Upstate/ CHEMICON, Temecula, CA). Baseline and post-intervention samples for the same participant were assayed in the same batch and run on the same gel to eliminate any differences caused by reaction or procedural batch-to-batch variations. Technicians were blind to group assignment. Telomerase activity is defined as 1 unit = the amount of product from one 293T cell/10,000 PBMCs, and was quantified using the software ImageQuant 5.2 (GE Healthcare, Piscataway, NJ).|Change from Baseline in Telomerase Activity at 4 months|Intention-to-treat analysis was conducted.||Standard arbitrary units, see above||Standard Deviation|Mean
56347|NCT01250509|Secondary|Weight||Change in Weight (baseline and 4 months)|Intention to treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.||kg||Standard Deviation|Mean
56348|NCT01250509|Primary|Change in Abdominal Fat|Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.|Change from Baseline in Abdominal Fat (baseline and 4 months)|Intent-to-treat analyses were conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.||grams||Standard Deviation|Mean
56349|NCT01250418|Primary|TcCO2 Above 50|% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.|Intraoperative, an average of about 1 and 1/2 hours.|||Percent time intraoperatrive||Standard Deviation|Mean
56350|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their second­line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second­line PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 24|ITT population||percentage of participants||95% Confidence Interval|Number
56351|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second­line PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 18|ITT population||percentage of participants||95% Confidence Interval|Number
56352|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their second­line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 12|ITT population||percentage of participants||95% Confidence Interval|Number
56353|NCT01250379|Secondary|Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)|"The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.||score on a scale||95% Confidence Interval|Mean
56354|NCT01250379|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)|"The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints.||score on a scale||95% Confidence Interval|Mean
56355|NCT01250379|Secondary|Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.||mm||95% Confidence Interval|Mean
56356|NCT01250379|Secondary|Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population; n=number of participants who completed the assessment at the specified timepoint.||mm||95% Confidence Interval|Mean
56357|NCT01250379|Secondary|Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)|"The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life."|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.||score on a scale||95% Confidence Interval|Mean
56358|NCT01250379|Secondary|Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)|The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either “no problems”, “some problems”, or “extreme problems” in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint||score on a scale||95% Confidence Interval|Mean
56369|NCT01250379|Secondary|Percentage of Participants With Third-Line PFS According to RECIST v1.1|Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)|Third line ITT population: all randomized participants who received third-line treatment.||percentage of participants|||Number
56359|NCT01250379|Secondary|Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)|The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either “no problems”, “some problems”, or “extreme problems” in the following categories: mobility (M) (“no problems”=“I have no problems in walking about” to “extreme problems”=“I am confined to bed”), self-care (SC) (“no problems”=“I have no problems with self-care” to “extreme problems”=”I am unable to wash or dress myself”), usual activities (UA) (“no problems”=“I have no problems performing my usual activities” to “extreme problems”=“I am unable to perform my usual activities”), pain/discomfort (P/D) (“no problems”=“I have no pain or discomfort” to “extreme problems”=“I have extreme pain or discomfort”), and anxiety/depression (A/D) (“no problems”=“I am not anxious or depressed” to “extreme problems”=‘I am extremely anxious or depressed”).|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint.||percentage of participants|||Number
56360|NCT01250379|Secondary|Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.|Months 6, 12, 18, and 24|ITT population||percentage of participants||95% Confidence Interval|Number
56361|NCT01250379|Secondary|Overall Survival (OS)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.|Baseline until death (up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
56362|NCT01250379|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason were reported.|Baseline until death (up to approximately 4 years)|ITT population||percentage of participants|||Number
56363|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6|Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Month 6|ITT population||percentage of participants||95% Confidence Interval|Number
56364|NCT01250379|Secondary|Time to Second- and Third-Line Tumor Progression|The median time, in months, from randomization to second- and third-line tumor progression. Second­ and third­line tumor progression was defined as third­line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||months||95% Confidence Interval|Median
56365|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line Tumor Progression|Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||percentage of participants|||Number
56366|NCT01250379|Secondary|Second- and Third-Line PFS|The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||months||95% Confidence Interval|Median
56367|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1|Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population||percentage of participants|||Number
56368|NCT01250379|Secondary|Third-Line PFS|The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)|Third line ITT population||months||95% Confidence Interval|Median
60997|NCT01196104|Secondary|Number of Single Coughing Episodes|Total number of times patients coughed only once|Baseline to Week 16|Safety Population||Cough episodes|||Number
56370|NCT01250379|Secondary|Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)|Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Months 3, 6, and 9|ITT population; only randomized participants with a CR or PR were included in the analysis.||percentage of participants||95% Confidence Interval|Number
56371|NCT01250379|Secondary|Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)|The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with a CR or PR were included in the analysis.||months||95% Confidence Interval|Median
56372|NCT01250379|Secondary|Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
56373|NCT01250379|Secondary|Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)|BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
56374|NCT01250379|Secondary|Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)|The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (>) 1.5 ULN, < 65 years of age, ≥ 65 years of age, < 70 years of age, ≥ 70 years of age, < 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free > 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free > 24 months, D-free ≤ 12 months, and D-free > 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor.||months||95% Confidence Interval|Median
56375|NCT01250379|Primary|Second-Line PFS|The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population||months||95% Confidence Interval|Median
56394|NCT01250145|Primary|Part A - Cumulative Skin Irritation by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter [mm]).|Day 1 through Day 22|All participants who entered the study and received patches are included in the analysis.||patches with Draize scores|Participants||Number
56376|NCT01250379|Primary|Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)|Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|Intent-to-Treat (ITT) population - all randomized participants.||percentage of participants|||Number
56377|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|12 weeks|||units on a scale||Standard Deviation|Mean
56378|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|12 weeks|||units on a scale||Standard Deviation|Mean
56379|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|12 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"||units on a scale||Standard Deviation|Mean
56380|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|4 weeks|||units on a scale||Standard Deviation|Mean
56381|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|4 weeks|||units on a scale||Standard Deviation|Mean
56382|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|4 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"||units on a scale||Standard Deviation|Mean
56383|NCT01250171|Secondary|Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were taken in a standing position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance specific to the test charts. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Standard Deviation|Mean
56384|NCT01250171|Secondary|Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8|Patients were instructed to record each occurrence of a desire for topical lubricant use in a patient diary. The percentage of patients in each of 6 categories (0-5, 6-10, 11-15, 16-20, 21-25, > 25 times) indicating the number of times a patient records a desire for artificial tear use per day was calculated at each time point. The percentage was calculated using the number of patients with any reported data on that day in the respective treatment group as the denominator.|Day 1 and Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Percentage of patients|||Number
56405|NCT01250119|Primary|Percentage of Participants Who Tested Positive for EGFR Mutations|All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.|14 days|Diagnostic population; Only participants who were tested for EGFR mutations were included in the analysis.||percentage of participants|||Number
56385|NCT01250171|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8|The OSDI is an instrument for measuring dry eye disease severity and effect on vision-related functions. Patients were asked a series of 12 questions; patients responded to the questions in regard to both eyes. Responses ranged from 0=None of the time to 4=All of the time. OSDI was calculated as the sum of the 12 question scores x 25/number of questions answered. The total score ranged from 0-100. A higher score indicates drier eyes. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Full Range|Mean
56386|NCT01250171|Secondary|Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8|Conjunctival redness was measured in the study eye at each visit by a masked evaluator. The evaluator compared the patient’s study eye with a set of 5 reference photos showing a normal eye and eyes with various degrees of redness. Redness was scored on a scale of 0-5 with a white normal eye = 0 and an eye with the most redness = 5. A higher score indicates more redness. A negative change score indicates improvement in redness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Full Range|Mean
56387|NCT01250171|Secondary|Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8|Tear film breakup time was defined as the time of last blink to the appearance of the first growing micelle after instilling 5 μl of non-preserved 2% sodium fluorescein into the lower palpebral conjunctiva of the study eye. Measurement was repeated 3 times and a mean tear film breakup time calculated. A lower score indicates a drier eye. A positive change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Seconds||Full Range|Mean
56388|NCT01250171|Secondary|Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8|The Schirmer test measures the production of tears. A small strip of filter paper is placed inside the lower eyelid (conjunctival sac) of each eye and the eyes are kept closed for 5 minutes. The paper is removed and the length of paper that is wet is measured as an index of tear production. The amount of tear production in the study eye was ranked on a 4 point scale: 0=Normal (≥ 15 mm wetting of the paper), 1=Mild (14-9 mm wetting of the paper), 2=Moderate (8-4 mm wetting of the paper), and 3=Severe (< 4 mm wetting of the paper). A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Full Range|Mean
56389|NCT01250171|Secondary|Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of the study eye. Staining was assessed in 3 regions (inferior, superior, and central) of the cornea and rated on a scale of 0 (no staining) to 4 (confluent staining). A mean of the 3 zones was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Standard Deviation|Mean
56390|NCT01250171|Primary|Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Week 4|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.||Units on a scale||Standard Deviation|Mean
56391|NCT01250145|Secondary|Part B - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Days 1 - 19 and 34 - 37|All randomized participants who received a patch.||patches with adhesive score|Participants||Number
56392|NCT01250145|Primary|Part B - Skin Irritation and Sensitization by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).|Days 1 - 19 and 34 - 37|All participants who entered the study and received patches are included in the analysis.||patches with Draize scores|Participants||Number
56393|NCT01250145|Secondary|Part A - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Day 1 through Day 22|All randomized participants who received a patch.||patches with adhesive score|Participants||Number
58755|NCT01222533|Secondary|FEV1 at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data.||Liter||Standard Error|Mean
56395|NCT01250119|Secondary|Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
56396|NCT01250119|Secondary|Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
56397|NCT01250119|Secondary|Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
56398|NCT01250119|Secondary|Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percentage of participants|||Number
56399|NCT01250119|Secondary|Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed at for the given parameter at the specified visit.||percentage of participants|||Number
56400|NCT01250119|Secondary|Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument|The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.|Screening, Baseline and Final or Withdrawal Visit up to 34 months|ITT population; number (n) = number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
56401|NCT01250119|Secondary|Survival Time in Months|Duration of time in months from Screening until Death due to any cause.|Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population||months||95% Confidence Interval|Median
56402|NCT01250119|Secondary|Probability of Being Alive and Free of Progression by Timepoint|Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.|Months 0, 3, 6, 9, 12, 15, and 18|ITT population||probability of being alive||95% Confidence Interval|Number
56403|NCT01250119|Primary|Percentage of Participants With EGFR Mutations by Subgroup|Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.|14 Days|Only participants with a valid EGFR mutations test result were included in the analysis.||percentage of participants|||Number
56404|NCT01250119|Secondary|Percentage of Participants With a Response by Best Objective Tumor Response|Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1”. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months|Intention-to-treat (ITT) population: All participants in the target population who were eligible for treatment and who actually received one dose of treatment.||percentage of participants|||Number
58790|NCT01222104|Secondary|Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).|30 days|||% of procedures with MVCs|Participants||Number
56406|NCT01250054|Primary|Overall Vision|Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week’s wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.|One week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
56407|NCT01250002|Secondary|Opioid Consumption (Morphine Equivalents)|opioid consumption (morphine equivalents)post operatively|24 hours|||mg||Full Range|Median
56408|NCT01250002|Primary|Quality of Recovery 40 Score|Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).|24 hours post surgery|Intent to treat.||units on a scale||Full Range|Median
56409|NCT01249872|Secondary|Change From Baseline of Spirometric Values|Preoperatively, after a detailed demonstration, baseline spirometry measurements of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) were measured, using a bedside spirometer (PowerCubeΤΜ, Ganshorn Medizin Electronic, Germany), on-line connected to a PC. Spirometry was standardized with each patient in a 30o head-up position and it was performed at least three times and the best measurement was recorded, according to the criteria of the European Respiratory Society .Postoperatively, spirometric values (FVC= Forced Vital Capacity, FEV1=Forced Expiratory Volume at 1 sec , PEFR= Peak Expiratory Flow Rate)were recorded at 12, 24, 36, 48, 72, 144 hours . Data are expressed as percentage of preoperative values, which are 100%.|up to 6th day postoperatively|||percentage of preoperative values||Standard Deviation|Mean
56410|NCT01249872|Secondary|Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively|Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 1mg(groups B and E)or 2mg (groups C and F) and as continuous infusion of 0,2mg/h ( all groups) at 24h and 48h postoperatively.All participants in each Group received the same dose of epidural morphine, as no participant missed a scheduled dose.|up to 48 hours postoperatively|||mg||Standard Deviation|Mean
56411|NCT01249872|Secondary|Consumption of Levobupivacaine at 24h and 48 h Postoperatively|Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively|up to 48 hours postoperatively|||mg||Standard Deviation|Mean
56412|NCT01249872|Secondary|Time to First Postoperative Ambulation|Time to being able to walk without assistance within the room or outside the room|up to 6 days|||hours||Standard Deviation|Mean
56413|NCT01249872|Secondary|Time to Postoperative Bowel Recovery|Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient|up to 6 days|||hours||Standard Deviation|Mean
56414|NCT01249872|Primary|Change From Baseline in Pain Scores (Visual Analogue Scale)|Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.|up to 48 h postoperatively|The sample size was chosen in order to detect a difference in the epidural levobupivacaine PCEA consumption at 48 hrs. We calculated that 14 patients per group would be adequate to detect statistical significance (α = 0.05, power = 90%), using data from a previous pilot study Then, we increased the sample size by 15%.||units on a scale||Standard Deviation|Mean
56415|NCT01249664|Secondary|Mean Change in Area of Leakage From Baseline at Week 24 - LOCF|A negative change from baseline indicates improvement, ie, less leakage.|Baseline, Week 24|||Disc areas||Standard Deviation|Mean
56416|NCT01249664|Secondary|Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks||Baseline, Week 24|||Percentage of participants|||Number
56417|NCT01249664|Secondary|Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline, Week 24|||Scores on a scale||Standard Deviation|Mean
56418|NCT01249664|Secondary|Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline, Week 24|||Scores on a scale||Standard Deviation|Mean
56419|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 48|||Disc areas||Standard Deviation|Mean
56420|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 24|||Disc areas||Standard Deviation|Mean
56421|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 48|||microns||Standard Deviation|Mean
56422|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 24|||microns||Standard Deviation|Mean
56423|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
56424|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
63555|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%||10-14 weeks|||% of participants|||Number
56425|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
56426|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
56427|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
56428|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
56429|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
56430|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
56431|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48|||Percentage of participants|||Number
56432|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
56433|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
56434|NCT01249664|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases|Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24|||Letters correctly read||Standard Deviation|Mean
56435|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24|||Percentage of participants|||Number
56436|NCT01249664|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24|||Letters correctly read||Standard Deviation|Mean
56437|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline to 8 weeks|Full analysis set (96 participants)||Participants|||Number
56452|NCT01249274|Primary|Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar|baseline, end of trial (week 12), 3-month post-trial follow-up|intent-to-treat||days of cocaine use between visits||95% Confidence Interval|Mean
56438|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn at week 4.||Participants|||Number
56439|NCT01249651|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn.||Number of days||Standard Deviation|Mean
56440|NCT01249651|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline to 8 weeks|Full analysis set (96 participants)||Number of days||Standard Deviation|Mean
56441|NCT01249417|Secondary|Goal Attainment Scale (GAS) Score|GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.||units on a scale||95% Confidence Interval|Least Squares Mean
56442|NCT01249417|Secondary|Physician’s Global Assessment (PGA) of the Treatment Response.|PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: “how would you rate the response to treatment in the subject’s lower limb(s) since the last injection?” Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.||units on a scale||95% Confidence Interval|Least Squares Mean
56443|NCT01249417|Primary|Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb|The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|Change from baseline to Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.||units on a scale||95% Confidence Interval|Least Squares Mean
56444|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period or 3 Months Post Treatment|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 3 months post 12-week trial period|intent-to-treat||participants who relapsed to cocaine use|||Number
56445|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 12 weeks|intent-to-treat||participants who relapsed to cocaine use|||Number
56446|NCT01249274|Secondary|Salivary Progesterone Concentrations|A comparison of salivary progesterone concentrations across all samples for all timepoints|week 2, week 6, week 10, week 12|intent-to-treat||pg/ml of salivary progesterone||Standard Error|Mean
56447|NCT01249274|Secondary|Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))|EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.|baseline to 12 weeks|intent-to-treat||units on a scale||Standard Error|Mean
56448|NCT01249274|Secondary|Cocaine Craving (Measured Weekly Using CCQ-Brief)|CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.|baseline to 12 weeks|intent-to-treat||units on a scale||95% Confidence Interval|Mean
56449|NCT01249274|Secondary|Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group|To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.|12 weeks postpartum|intent-to-treat||adverse events|||Number
56450|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|baseline, end of trial (week 12) and 3-month post-trial follow-up|intent-to-treat||proportion of positive urines per week||95% Confidence Interval|Mean
56451|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|weekly measurements, baseline to 12 weeks|intent-to-treat||proportion of positive urines per week||95% Confidence Interval|Mean
56453|NCT01249274|Primary|Mean Number of Days Per Week of Cocaine Use|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.|Weekly measurements, Baseline to 12 weeks|intent-to-treat||number of days per week of cocaine use||Standard Deviation|Mean
56454|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56455|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population|Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56456|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population|Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56457|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56458|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population|Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56459|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population|Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56460|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56461|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56462|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56463|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56464|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56465|NCT01249261|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population||Percent Change||Standard Error|Mean
56466|NCT01249157|Primary|To Evaluate the Accuracy of Preoperative 18FDG PEM|using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.|2 years|No data displayed because Outcome Measure has zero total participants analyzed.|||||
56467|NCT01249131|Primary|Apparent Volume of Distribution (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
60998|NCT01196104|Secondary|Number of Subjects Reporting Intermittent Coughing Episodes|Number of subjects reporting Intermittent Coughing Episodes|Baseline to Week 16|Safety Population||Number of participants|||Number
56468|NCT01249131|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
56469|NCT01249131|Primary|Minimum Observed Plasma Concentration (Cmin)||Day 1 at 0 hour (predose)|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
56470|NCT01249131|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
56471|NCT01249131|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
56472|NCT01249118|Primary|Percent of GDC-0973 Excreted in the Urine (% Excreted) for IV and Oral GDC-0973|% Excreted is the mean percentage of dose recovery in urine and calculated as: (Aeu divided by dose) multiplied by 100, where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose|Full analysis population.||Percent dose excreted||Geometric Coefficient of Variation|Geometric Mean
56473|NCT01249118|Primary|Renal Clearance (CLR) of IV and Oral GDC-0973|CLR was calculated as Aeu divided by AUC (0 - ∞), where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose and AUC(0 - ∞) was area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity hrs post-dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 for plasma; 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose for urine|Full analysis population.||L/hr||Geometric Coefficient of Variation|Geometric Mean
56474|NCT01249118|Primary|Amount of Drug Excreted in the Urine (Aeu) of IV and Oral GDC-0973|The cumulative amount of drug excreted in urine over the entire collection interval of 96 hrs was calculated by adding the Aeu of the intervals 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 hrs where Aeu was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose on Day 1|Full analysis population.||mg||Geometric Coefficient of Variation|Geometric Mean
56475|NCT01249118|Primary|Mean Absorption Time (MAT)|MAT is mean time required for the drug to reach the central compartment. MAT was estimated from the mean resident time (MRT) from oral and IV administration. MAT was calculated as MRT last of oral dose minus MRT last of IV dose. MAT is analyzed when drug is administered orally (only for non-IV routes of administration).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|"Full analysis population who received oral dose of GDC-0973. Here, number of participants analyzed signified those participants who were evaluable for this outcome."||hr||Geometric Coefficient of Variation|Geometric Mean
56476|NCT01249118|Primary|Absolute Oral Bioavailability (F) of GDC-0973|Absolute oral bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. F = [AUC (0-∞), oral multiplied by Dose IV] divided by [AUC (0-∞), IV multiplied by Dose oral]. Absolute oral bioavailability is determined for drugs which are administered orally. IV dose is 100% in systemic circulation (dosed directly) and hence no estimation is required.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.||Ratio||Geometric Coefficient of Variation|Geometric Mean
56477|NCT01249118|Primary|Apparent Volume of Distribution (Vz/F) of Oral GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.||Liter||Geometric Coefficient of Variation|Geometric Mean
56478|NCT01249118|Primary|Volume of Distribution at Steady State (Vss) of IV GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose of Day 1|Full analysis population who received IV dose of GDC-0973.||Liter||Geometric Coefficient of Variation|Geometric Mean
56479|NCT01249118|Primary|Apparent Oral Clearance (CL/F) of Oral GDC-0973|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modelling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.||L/hr||Geometric Coefficient of Variation|Geometric Mean
56480|NCT01249118|Primary|Systemic Clearance (CL) of IV GDC-0973|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received IV dose of GDC-0973.||Liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
60999|NCT01196104|Secondary|Number of Subjects Reporting Cough Episodes|Number of Subjects Reporting Cough Episodes|Baseline to Week 16|Safety Population||Number of participants|||Number
56481|NCT01249118|Primary|Plasma Decay Half-Life (t1/2) of IV and Oral GDC-0973|t1/2 is the time measured for the plasma concentration of GDC-0973 to decrease by one half.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||hr||Geometric Coefficient of Variation|Geometric Mean
56482|NCT01249118|Primary|Dose Normalized AUC (0 - ∞) [AUC (0 - ∞)dn] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞)dn is AUC(0 - ∞) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
56483|NCT01249118|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
56484|NCT01249118|Primary|Dose Normalized AUC (0-t) [AUC (0-t)dn] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). AUC (0-t)dn is AUC (0-t) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
56485|NCT01249118|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
56486|NCT01249118|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||hr||Full Range|Median
56487|NCT01249118|Primary|Minimum Observed Plasma Trough Concentration (Cmin) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
56488|NCT01249118|Primary|Dose Normalized Cmax [Cmax(dn)] of IV and Oral GDC-0973|Cmax(dn) is Cmax divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
56489|NCT01249118|Primary|Maximum Observed Plasma Concentration (Cmax) of IV and Oral GDC-0973||Part 2: 0 hours (Hrs) (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population included participants who were randomized, received study drug, and had at least 1 valid PK parameter.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
56490|NCT01249092|Secondary|Safety of Therapy in the Pilot Study of PTX Therapy in Patients With PBC Will be Assessed|The number of participants that experienced any severe adverse events will be monitored and recorded.|6 months|||participants|||Number
56491|NCT01249092|Secondary|Change in Serum Concentration of Tissue Inhibitor Metalloproteinase 1 (TIMP-1) After PTX Therapy.|Serum concentration of tissue inhibitor metalloproteinase 1 (TIMP-1), a fibrosis biomarker of interest, will be measured and the change in serum levels between entry and end of study will be calculated.|6 months|Serum samples from both timepoints (entry and end of study) were available in only 16 of the 18 subjects who completed the study.||ng/mL||Standard Error|Mean
56492|NCT01249092|Primary|Change in Serum Alkaline Phosphatase Levels.|Serum alkaline phosphatase levels at entry and at 6 months of therapy with PTX will be measured and compared.|6 months|||U/L||Standard Deviation|Mean
56493|NCT01248936|Primary|Number of Participants With Any Serious Adverse Event, Death and Cause of Death|Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.||participants|||Number
56494|NCT01248936|Primary|Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the ‘National Cancer Institute Common Terminology Criteria for Adverse Events’ (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.||participants|||Number
56495|NCT01248936|Secondary|Mean Time to Complete Response/Partial Response|Mean time to Complete Response (CR)/Partial Response(PR) (confirmed or unconfirmed was assessed). Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||Months||Standard Deviation|Mean
56496|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was confirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants were assessed for best overall response by investigator as per RECIST v1.1. The ‘n’ is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||Participants|||Number
56497|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed)|The best overall response (confirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was confirmed. Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||Participants|||Number
56498|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. This endpoint was tumor response category according to investigator assessment per RECIST v1.1 for efficacy assessment. The ‘n’ is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated patients who had measurable disease at baseline and at least one post-baseline tumor assessment.||Participants|||Number
56499|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed)|The best overall response (unconfirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed. Participants were assessed for best overall response by investigator as per 'Response Evaluation Criteria in Solid Tumors' (RECIST v1.1).|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.||participants|||Number
56500|NCT01248884|Primary|Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
56501|NCT01248884|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
56502|NCT01248884|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
56503|NCT01248884|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
56504|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
56505|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
56506|NCT01248884|Secondary|Number of Subjects With a Vaccine Response to PT and PRN.|Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
56737|NCT01245387|Primary|Number of Participants With PED at Week 18|PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 18|FAS; N=number of participants with evaluable data.||Participants|||Number
56507|NCT01248884|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||µg /mL||95% Confidence Interval|Geometric Mean
56508|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
56509|NCT01248884|Secondary|Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
56510|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
56511|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
56512|NCT01248884|Primary|Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
56513|NCT01248884|Secondary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
56514|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.||Subjects|||Number
56515|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14|BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Score on a scale||Standard Deviation|Mean
56516|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14|BASFI is a participant’s self-assessment, represented as a mean (Visual Analogue Scale [Score]; 0 cm [easy] to 10 cm [impossible]) of 10 questions, 8 of which relate to the participant’s functional anatomy and 2 of which relate to a participant’s ability to cope with everyday life. A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Score on a scale||Standard Deviation|Mean
56517|NCT01248793|Secondary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 24|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Participants|||Number
56518|NCT01248793|Primary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment||Participants|||Number
56738|NCT01245387|Primary|Number of Participants With PED at Week 12|PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 12|FAS; N=number of participants with evaluable data.||Participants|||Number
56519|NCT01248780|Secondary|HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline|The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ.|Baseline to Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Scores on a scale||Standard Deviation|Mean
56520|NCT01248780|Secondary|American College of Rheumatology 20 Response, Using CRP, at Week 24|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Number of participants|||Number
56521|NCT01248780|Secondary|Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient’s assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of “Good” or “Moderate” at Week 14. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A “Moderate” response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14."|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Number of participants|||Number
56522|NCT01248780|Primary|American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.||Number of participants|||Number
56523|NCT01248728|Secondary|Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language|"The PLS-4 is a language measure that provides a global assessment of a child's language functioning abilities, receptive and expressive language.~Secondary outcome measure domain: Total language standard score~Total Language Standard Score Range:~Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities)~The total language standard score is computed from a sum of the auditory comprehension and expressive communication standard scores, then converted into the total language standard score.~Change of total language standard scores from baseline to week 24 is reported. Positive change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
56524|NCT01248728|Secondary|Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite|"The VABS is a measure of adaptive behavior in daily settings. Secondary measure domain: The adaptive functioning composite describes an individuals overall functioning~Adaptive Behaviour Composite Standard Score Range:~Minimum range: 20 (low adaptive functioning) Maximum range: 160 (high adaptive functioning)~The adaptive behaviour composite standard score is computed from the sum of standard scores from the communication, daily living skills, socialization and motor skills domains and converted into the adaptive behavior composite standard score.~Change in the adaptive behaviour composite standard score from baseline to week 24 is reported. Positive change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
56525|NCT01248728|Secondary|Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)|"The CGI-I is a seven-point scale that provides a clinician rating of global improvement and as such is already inherently a measure of change. It requires the clinician to assess the degree to which the participant's illness has improved or worsened relative to a baseline state before the intervention.~Change is rated as:~0- Not assessed~Very Much Improved~Much Improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse~Participants are classified as responders if their CGI-I score was 1 or 2 and non-responders for CGI-I scores of 3 to 7."|24 weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||participants classified as responders|||Number
56526|NCT01248728|Primary|Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite|"The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours.~Primary Outcome domain: Externalizing Problems composite~Externalizing Problems Composite T-Score Range:~Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems)~The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score.~Mean change between baseline and week 24 is reported. A negative change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
56538|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)||g/dL/h||Standard Error|Least Squares Mean
56539|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1|Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)||g||Standard Error|Least Squares Mean
56527|NCT01248728|Primary|Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score|"The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity.~PDDBI Autism Composite Scale Range:~Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity)~The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score.~Mean change between baseline and week 24 is reported. A negative change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.||units on a scale||95% Confidence Interval|Mean
56528|NCT01248468|Secondary|Percent of Subjects Who Are Free of Photophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|||Percent of participants|||Number
56529|NCT01248468|Secondary|Percent of Subjects Who Are Free of Phonophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.||Percent of participants|||Number
56530|NCT01248468|Secondary|Percent of Subjects Who Are Free of Nausea at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.||percent of participants|||Number
56531|NCT01248468|Primary|Percent of Subjects Who Are Pain Free at 2 Hours.|Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.||Percent of participants|||Number
56532|NCT01248455|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|3 years, 5 months|||participants|||Number
56533|NCT01248455|Primary|Response Rate|Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR >25% and <50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium >2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin <10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.|1 year|Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).||percentage of participants|||Number
56534|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||g||Standard Error|Least Squares Mean
56535|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1|Treated set (OR)||g||Standard Error|Least Squares Mean
56536|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28|"Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||g||Standard Error|Least Squares Mean
56537|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||g/dL/h||Standard Error|Least Squares Mean
63556|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%||10-14 weeks|||% of participants|||Number
56540|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28|"Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|Baseline and day 28|Treated set (OR) for patients who completed the day 28 visit||umol/kgFFM/min||Standard Error|Least Squares Mean
56541|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1|Change from baseline in rate of endogenous glucose production (EGP) fast after one dose|Baseline and day 1|Treated set (OR)||umol/kgFFM/min||Standard Error|Least Squares Mean
56542|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 28|"Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable"|Baseline and day 28|Treated set, which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)), for patients who completed the day 28 visit||mmol/L||Standard Error|Least Squares Mean
56543|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 1|Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1|Baseline and day 1|Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR))||mmol/L||Standard Error|Least Squares Mean
56544|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|A multiple linear regression model approach was used to estimate gastric emptying based on the breath test samples at each time point. Gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal|||proportion of tracer||Standard Deviation|Mean
56545|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy|The scintigraphic gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal|||proportion of tracer||Standard Deviation|Mean
56546|NCT01248221|Primary|Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.|4 hours after ingestion of standard meal|||minutes||Standard Deviation|Mean
56547|NCT01248221|Primary|Gastric Emptying Half Time Measured by Scintigraphy|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by standard 99m Tc scintigraphy.|4 hours after ingestion of standard meal|||minutes||Standard Deviation|Mean
56548|NCT01248130|Primary|Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores||weekly||||||
56549|NCT01248130|Primary|Change in Social Responsiveness Scale (SRS) Total Raw Score|Change in SRS Total Raw Score|pre-treatment, 6 weeks, post-treatment (12 weeks)||||||
56550|NCT01248065|Secondary|Exacerbations|Outcome defined as number of exacerbations per person-year.|Overall exacerbation rate during 28-week trial|||Exacerbations/person-year||95% Confidence Interval|Number
56551|NCT01248065|Secondary|Lung Function Change From Baseline|FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline.|Change is measured as value at 28 weeks minus baseline value.|||Liters||95% Confidence Interval|Least Squares Mean
56552|NCT01248065|Primary|Treatment Failure|Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.|Twenty-eight week intervention period from randomization until end of trial.|||Percentage of participants||95% Confidence Interval|Number
56553|NCT01248013|Primary|Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.|The IBS Symptom Severity Scale has four components, severity of abdominal pain, number of days with pain in past 10 days, abdominal distension, bowel habit and interference with life in general. Maximum score is 500, minimum score is 0. The lower the score, the lower the symptom severity. Participants are considered clinically improved if they have a reduction in score of 50 points or greater.|One year after termination of treatment|||percentage of participants|||Number
56554|NCT01248013|Secondary|Outcome Predictors|to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result|one year||||||
56555|NCT01248013|Primary|Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome|assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months|one year||||||
56556|NCT01247974|Primary|Primary Effectiveness Endpoint|Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.|7 days postoperatively or hospital discharge, whichever is sooner|Primary analysis was based upon the ITT population using multiple imputation to impute missing values. The ITT population was defined as all subjects who provided informed consent and were randomized in the trial.||percentage of participants|||Number
56557|NCT01247974|Primary|Primary Safety Endpoint|"A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure:~Death~Myocardial Infarction (MI)~Stroke~Mediastinal Reoperation~Percutaneous Coronary Intervention (PCI)"|30 days postprocedure|Performed with the FAS population using multiple imputation methods to impute values for missing or incomplete data. FAS population was defined as subjects in the ITT population who had CABG surgery and received their assigned treatment.||percentage of participants|||Number
56558|NCT01247922|Secondary|Median Treatment Duration||From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)|SAF||days||Full Range|Median
56574|NCT01247428|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge|8 hours|||percentage of participants||95% Confidence Interval|Number
94427|NCT00860470|Secondary|Extremely Pre-term|Risk of birth before 28 weeks gestation|December 2014|||participants|||Number
56559|NCT01247922|Secondary|Best Overall Response|Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing.|End of treatment (The mean treatment duration was 170.5 days.)|SAF||participants|||Number
56560|NCT01247922|Primary|Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)|Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.|From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)|The analysis population is the Safety Analysis Set (SAF) consisted of all enrolled patients who received at least 1 dose of study drug.||participants|||Number
56561|NCT01247428|Secondary|OCT Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|18 M|27 out of 30 patients analyzed||percentage of struts uncovered||Full Range|Median
56562|NCT01247428|Secondary|Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 9/30 patients had evaluable OCT at the 8 month timeframe.||percentage of struts uncovered||Full Range|Median
56563|NCT01247428|Secondary|IVUS Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|18 months|20 out of 30 participants analyzed||percentage of volume obstruction||Standard Deviation|Mean
56564|NCT01247428|Secondary|Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 25/30 patients had evaluable IVUS data.||percentage of volume obstruction||Standard Deviation|Mean
56565|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|18 months|Population includes participants from whom data was collected.||participants|||Number
56566|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|4 months, 6 months, 8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months.||participants|||Number
56567|NCT01247428|Secondary|Stent Thrombosis|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|240 days|||percentage of participants||95% Confidence Interval|Number
56568|NCT01247428|Secondary|Target Lesion Failure (TLF)|"Target lesion failure (TLF) is defined as the composite endpoint of:~cardiac death,~target-lesion myocardial infarction (Q wave or non-Q wave), and~clinically indicated target lesion revascularization"|240 days|||percentage of participants||95% Confidence Interval|Number
56569|NCT01247428|Secondary|Target Vessel Failure (TVF)|"Target vessel failure (TVF) is defined as the composite endpoint of:~cardiac death,~target-vessel myocardial infarction (Q wave or non-Q wave), and~clinically indicated target vessel revascularization"|240 days|||percentage of participants||95% Confidence Interval|Number
56570|NCT01247428|Secondary|Clinically-driven Target Vessel Revascularization (TVR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:~A positive history of recurrent angina pectoris, presumably related to the target vessel;~Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;~Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);~A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days|||percentage of participants||95% Confidence Interval|Number
56571|NCT01247428|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:~A positive history of recurrent angina pectoris, presumably related to the target vessel;~Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;~Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);~A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days|||percentage of participants||95% Confidence Interval|Number
56572|NCT01247428|Secondary|Total Myocardial Infarction (MI)|"Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.~Non-Q-wave MI (NQWMI): the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves."|240 days|||percentage of participants||95% Confidence Interval|Number
56573|NCT01247428|Secondary|Total Mortality|Total mortality (cardiac and non-cardiac)|240 days|||percentage of participants||95% Confidence Interval|Number
56578|NCT01247428|Primary|Angiographic In-Stent Late Lumen Loss|In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.|8 months|Last observation used, such that patients (n=10) in the 8 month analysis is reported.||mm||Standard Deviation|Mean
56579|NCT01247285|Secondary|AUC0-inf of Norfluoxetine.|Informational comparison of AUC0-inf values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56580|NCT01247285|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56581|NCT01247285|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
56582|NCT01247285|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56583|NCT01247285|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56584|NCT01247285|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
56585|NCT01247272|Secondary|AUC0-inf of Norfluoxetine.|Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56586|NCT01247272|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56587|NCT01247272|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
56588|NCT01247272|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56589|NCT01247272|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
56590|NCT01247272|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
56591|NCT01247220|Secondary|Retinal Thickness|central foveal thickness on optical coherence tomography|6 and 12 months|||microns||Standard Deviation|Mean
56592|NCT01247220|Secondary|Number of Ranibizumab Injections|Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in second six months of observation period|12 months|||injections||Full Range|Mean
56593|NCT01247220|Primary|Visual Acuity|ETDRS visual acuity|6 and 12 months|||letters on ETDRS Visual Acuity Chart||Standard Deviation|Mean
56594|NCT01245751|Secondary|Number of Participants Reporting One or More Adverse Experiences|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.|Up to 42 days postvaccination|Analysis included all vaccinated participants who had any safety follow-up||Participants|||Number
56595|NCT01245751|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 only.||Fold Rise||95% Confidence Interval|Geometric Mean
56596|NCT01245751|Primary|Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only.||gpELISA Units/mL||95% Confidence Interval|Geometric Mean
56739|NCT01245387|Primary|Number of Participants With PED at Week 6|PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 6|FAS; N=number of participants with evaluable data.||Participants|||Number
56597|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C But Did Not Achieve Target Lipid Levels for TG and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
56598|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
56599|NCT01245738|Primary|Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
56600|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C and LDL-C But Did Not Achieve Target Lipid Levels for TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
56601|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG and LDL-C But Did Not Achieve Target Lipid Levels for HDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.||Percentage of Participants|||Number
56602|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for LDL-C But Did Not Achieve Target Lipid Levels for HDL-C and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements at Week 12.||Percentage of Participants|||Number
56603|NCT01245738|Primary|Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins|TG levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between Baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had TG measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
56604|NCT01245738|Primary|Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins|HDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had HDL-C measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
56605|NCT01245738|Primary|Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins|LDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had LDL-C measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
56606|NCT01245738|Primary|Change From Baseline in TC Levels After Treatment|TC levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the Full Analysis Set (FAS) Population who had a TC measurements at baseline and Week 12.||mg/dL||Standard Deviation|Mean
56607|NCT01245738|Primary|Triglycerides (TG) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken. This level was considered the baseline value. A TG level of >150 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a TG measurement at baseline.||mg/dL||Standard Deviation|Mean
56608|NCT01245738|Primary|High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken. This level was considered the baseline value. A HDL-C level of <40 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a HDL-C measurement at baseline.||mg/dL||Standard Deviation|Mean
56609|NCT01245738|Primary|Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken. This level was considered the baseline value. A LDL-C level of >70 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a LDL-C measurement at baseline.||mg/dL||Standard Deviation|Mean
56610|NCT01245738|Primary|Total Cholesterol (TC) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken. This level was considered the baseline value. A TC level of >240 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a total cholesterol measurement at baseline.||mg/dL||Standard Deviation|Mean
56611|NCT01245647|Secondary|CD4 Count (Mean)|Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.|4 months|||CD4 count (cells/ml)||Standard Deviation|Mean
56612|NCT01245647|Secondary|HIV Viral Load Suppressed|Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)|4 months|||percentage of persons with suppressed VL|||Number
56614|NCT01245647|Secondary|HIV Medication Adherence (95% or Better)|Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.|Month 4|Only persons who reported current HIV medication use (n=13) were considered for this outcome, and we included data from the 10 persons who completed the 4-month assessment.||percentage of participants|||Number
56615|NCT01245647|Primary|Number of Drinks Per Week|Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.|Month 4|All participants who provided data at the 4-month follow-up were included (n=15), which is 79% of persons who were randomized.||standard alcohol drinks per week||Standard Deviation|Mean
56616|NCT01245595|Primary|Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria|Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.|5 days|||participants|||Number
56617|NCT01247090|Primary|Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period||Baseline and Two Weeks|||mm Hg||Standard Deviation|Mean
56618|NCT01247064|Secondary|Parental Perception of Improvement of Breathing After Study Medication||1 hour|||percentage of participants|||Number
56619|NCT01247064|Secondary|Oxygen Saturation Change||Baseline and 1 hour|||percent||95% Confidence Interval|Mean
56620|NCT01247064|Secondary|Respiratory Rate Change||Baseline and 1 hour|||breaths per minute||95% Confidence Interval|Mean
56621|NCT01247064|Secondary|Rate of Hospitalization||1 day|||percentage of participants|||Number
56622|NCT01247064|Primary|Respiratory Assessment Change Score (RACS)|The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.|Baseline and 1 hour|||units on a scale||95% Confidence Interval|Mean
56623|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Mean
56624|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Mean
56625|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Mean
56626|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Log Mean
56627|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Log Mean
56628|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7|||log10 TCID(50)/ml||Standard Deviation|Log Mean
56629|NCT01246999|Primary|Number of Subjects Shedding Vaccine Virus of Each Subtype by PCR|Nasal washes were collected on days 2, 4 and 7 after vaccination. Nasal swab specimens were tested for the presence of vaccine viruses by quantitative viral culture in MDCK cells at 33º C and by real-time quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) amplification. The limit of detection of vaccine viruses was 10^0.6 tissue culture infectious doses (50%)/ml for virus culture and 10^0.4 tissue culture infectious doses (50%)/ml for qRT-PCR.|baseline to day 7|Outcome for shedding of live vaccine in all participants who received a live vaccine||participants|||Number
56630|NCT01246973|Secondary|Percentage of Subjects With Moist Desquamation|Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.|6 weeks|||percentage of participants|||Number
56631|NCT01246973|Primary|Mean Radiation Dermatitis Severity Score|The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients). The RDS score ranges from 0-4 with higher scores indicating worse outcome.|6 weeks|||units on a scale||Standard Deviation|Mean
56632|NCT01246960|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion (up to Month 28.3)|Safety population: randomized participants who received any quantity of study drug (Ramucirumab, mFOLFOX6, or placebo).||participants|||Number
56633|NCT01246960|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Months 1, 2, 4, 6, and 8|Randomized participants who received any quantity of ramucirumab or placebo, and were evaluated for the presence of anti-ramucirumab antibodies.||participants|||Number
56634|NCT01246960|Secondary|Time to Disease Progression (TTP)|TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.|Randomization to measured PD (up to Month 25.0)|ITT population: all randomized participants. Thirty-five participants in the Ramucirumab and mFOLFOX6 treatment arm and 31 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||Full Range|Median
56635|NCT01246960|Secondary|Duration of Response|Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time of first response to measured PD (up to Month 23.0)|Randomized participants who achieved an objective response of CR or PR. Eight participants in the Ramucirumab and mFOLFOX6 treatment arm and 8 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||95% Confidence Interval|Median
56636|NCT01246960|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)*100.|Randomization to measured PD (up to Month 23.0)|ITT population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
56637|NCT01246960|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.|Randomization to date of death from any cause (up to Month 28.3)|ITT population: all randomized participants. Twenty-seven participants in the Ramucirumab and mFOLFOX6 treatment arm and 32 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||95% Confidence Interval|Median
56638|NCT01246960|Primary|Progression-Free Survival (PFS)|PFS was defined using Response Evaluation Criteria in Solid Tumors [RECIST version (v.) 1.1] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.|Randomization to measured PD or date of death from any cause (up to Month 25.0)|ITT population: all randomized participants. Fourteen participants in the Ramucirumab and mFOLFOX6 treatment arm and 15 participants in the Placebo and mFOLFOX6 treatment arm were censored.||months||95% Confidence Interval|Median
56639|NCT01246791|Primary|Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hr^-1||Standard Deviation|Mean
56640|NCT01246791|Primary|Elimination Rate Constant (Kel) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hr^-1||Standard Deviation|Mean
56641|NCT01246791|Primary|Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
56642|NCT01246791|Primary|Mean Residence Time (MRT) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
56643|NCT01246791|Primary|Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
56644|NCT01246791|Primary|Plasma Half Life (t1/2) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
56740|NCT01245387|Primary|Number of Participants With Pigment Epithelial Detachment (PED) at Baseline|PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Baseline|FAS; N=number of participants with evaluable data.||Participants|||Number
56645|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
56646|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||hours||Standard Deviation|Mean
56647|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||pg/mL||Standard Deviation|Mean
56648|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||ng/mL||Standard Deviation|Mean
56649|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||pg･hr/mL||Standard Deviation|Mean
56650|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01|||ng･hr/mL||Standard Deviation|Mean
56651|NCT01246713|Primary|Acetaminophen Metabolites|Area-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose.|8 hours|||mcg.hr/ml||Standard Error|Mean
56652|NCT01246479|Secondary|Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Severity, Duration and Relationship to Vaccinations.|Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322). Severity, duration and relationship to vaccinations.|Months 12, 24 and 36||||||
56653|NCT01246479|Secondary|Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)|Months 12, 24 and 36||||||
56654|NCT01246479|Secondary|GMTs and Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|GMTs and rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)|Month 24, 36||||||
56655|NCT01246479|Secondary|GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12 After the First IC51 Vaccination (in Study IC51-322)|GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322)|Month 12||||||
56656|NCT01246479|Primary|Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)|Month 12|intention to treat population; assessment of seroprotection ~1 year post primary vaccination series in parent study IC51-322||percentage of participants||95% Confidence Interval|Number
56657|NCT01246349|Primary|Child Dietary Self-Efficacy Scale|"A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods.~The questionnaire is made up of 20 likert items with 3 response options, including not sure, a little sure, and very sure. Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, How sure are you that you could eat cereal instead of a donut? Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy."|Baseline, 6 month follow-up|||scores on a scale||Standard Deviation|Mean
56658|NCT01246349|Secondary|Psychological Well-being|Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)|Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment||||||
56659|NCT01246349|Secondary|Physiological Outcomes: Waist Circumference|Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.|Baseline, 6 month follow-up|||cm||Standard Deviation|Mean
56660|NCT01246349|Secondary|Physiological Outcomes: BMI|The study used a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight was measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age was determined with the use of an age appropriate growth curve chart.|Baseline, 6 month follow-up|||z-score||Standard Deviation|Mean
56705|NCT01245439|Secondary|Number of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population||participants|||Number
56661|NCT01246349|Primary|Weight Efficacy Life-style Questionnaire|"A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight.~The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident).~The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses.~The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined."|Baseline, 6 month follow-up|||scores on a scale||Standard Deviation|Mean
56662|NCT01246258|Other Pre-specified|Utricular Centrifugation Test (UCF)|balance assessment|one day|||participants|||Number
56663|NCT01246258|Primary|Vestibular Evoked Myogenic Potentials (VEMPs)|These are the balance tests that specifically assess the otolith organ.|one day|||participants|||Number
56664|NCT01246076|Secondary|Time to Progression|The time to progression is defined as the time from registration to the date of progression or last follow-up. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)|Time to progression was not analyzed. This was a prespecified secondary outcome but due to the early termination of the study time to progression was not followed.|||||
56665|NCT01246076|Secondary|Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4||30 days after end of treatment (up to 60 weeks)|||participants|||Number
56666|NCT01246076|Secondary|Time to Discontinuation of Treatment||Up to 56 weeks (14 cycles)|16 out of 24 participants were evaluable for this outcome measure as these 16 participants completed at least the first cycle of treatment.||cycles||Full Range|Median
56667|NCT01246076|Secondary|Duration of Response||Until 6 months after end of treatment|8 participants had a response -- all had MCR.||days||Full Range|Median
56668|NCT01246076|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who were alive 6 months after end of treatment.|6 months after end of treatment (up to 82 weeks from start of treatment)|||percentage of participants|||Number
56669|NCT01246076|Primary|Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria|"Complete remission (CR): ≤5% myeloblasts bone marrow blasts, normal maturation in all cell lines (dysplasia will be noted), ≥11 g/dl peripheral blood hemoglobin, ≥100x10^9cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood absolute neutrophil count (ANC), and 0% peripheral blood blasts.~Marrow complete remission (MCR): ≤5% myeloblasts and decreased by ≥50% compared to pre-treatment bone marrow blasts, bone marrow morphology not relevant, and peripheral blood (if hematological improvement they will be noted in addition to marrow CR).~Partial remission (PR): previously had ≥5% myeloblasts and now have ≥5% myeloblasts but decreased by ≥50% compared to pre-treatment, bone marrow morphology not relevant, ≥11 g/dl peripheral blood hemoglobin, ≥100x109cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood ANC, and 0% peripheral blood blasts"|Up to 56 weeks (14 cycles of treatment)|8 participants were not evaluable for this outcome measure because they did not complete at least one cycle of therapy.||participants|||Number
56670|NCT01246011|Secondary|Major Bleeding Events.|Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL.|At 2weeks post CABG||||||
56671|NCT01246011|Primary|Coronary Artery Bypass Vein Graft Patency|Vein graft patency as measured by computed tomography|Approximately 30 Days post CABG|No analysis will be done due to early study termination||Vein Grafts|||Number
56672|NCT01245764|Secondary|GMT of Anti-HPV Type 18 Antibody|Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
56673|NCT01245764|Secondary|GMT of Anti-HPV Type 16 Antibody|Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
56674|NCT01245764|Secondary|GMT of Anti-HPV Type 11 Antibody|Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
56675|NCT01245764|Secondary|Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody|Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||milli Merck U/mL||95% Confidence Interval|Geometric Mean
56701|NCT01245439|Secondary|Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL, Total cholesterol >240 mg/dL, High Density Lipoprotein (HDL) >60 mg/dL and Triglycerides (TG) >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; Number (n) equals (=) number of participants analyzed at the specified visit for the given parameter.||participants|||Number
56676|NCT01245764|Primary|Number of Participants With Serious Adverse Experiences|A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention|From the time of informed consent is signed through the last study visit (up to 19 months)|The analysis included all participants receiving at least 1 vaccination in study Phase A or B and who had postvaccination follow-up||Participants|||Number
56677|NCT01245764|Primary|Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)||Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had temperature data||Participants|||Number
56678|NCT01245764|Primary|Number of Participants With Injection-site Adverse Experiences|Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences|Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had postvaccination follow-up||Participants|||Number
56679|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 18|Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of >=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
56680|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 16|Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
56681|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 11|Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of >=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
56682|NCT01245764|Primary|Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6|Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.||Participants|||Number
56683|NCT01245439|Secondary|Health Assessment Questionnaire Score (General Score)|The Stanford HAQ disability index is a participant completed questionnaire specific for RA. It consists of 20 questions referring to 8 component sections: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in validated translation into the local languages at the participating sites and was scored. Every question in each section was scored at a scale from 0 to 3 by the participant where 0 = able to perform the activity without any difficulty and 3 = unable to perform the activity. General score was calculated as an average of the 8 sections.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||units on a scale||Standard Deviation|Mean
56684|NCT01245439|Secondary|Participant's Assessment of Pain|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||mm||Standard Deviation|Mean
56685|NCT01245439|Secondary|Participant's (PT) and Investigator's (IN) Assessment of Disease Activity|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||mm||Standard Deviation|Mean
56686|NCT01245439|Secondary|Mean Number of Tender and Swollen Joints|Participants were asked to classify 28 joints as tender or not tender and swollen or not swollen to count the total number of tender and swollen joints by visit.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population||joints||Standard Deviation|Mean
56687|NCT01245439|Secondary|Erythrocyte Sedimentation Rate|ESR is an inflammatory marker used to measure inflammation in RA and is measured as millimeters per hour (mm/hr).|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category||mm/hr||Standard Deviation|Mean
56688|NCT01245439|Secondary|C-Reactive Protein Levels|CRP is an inflammatory marker used to measure inflammation in RA and is measured as mg/dL.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.||mg/dL||Standard Deviation|Mean
61189|NCT01195090|Secondary|Baseline Alanine-aminotransferase (ALT)|Baseline alanine-aminotransferase|Baseline|Baseline alanine-aminotransferase||IU/L||Standard Deviation|Mean
56689|NCT01245439|Secondary|Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: ≥ 20/50/70/90 % improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. .|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.||Percentage of participants|||Number
56690|NCT01245439|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: greater than or equal to (≥) 20/50/70/90 percent (%) improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
56691|NCT01245439|Secondary|Disease Activity Score as Measured By DAS28 at Each Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. n = participants who were evaluable for specified category||units on a scale||Standard Deviation|Mean
56692|NCT01245439|Secondary|Percentage of Participants Achieving Their First Remission Status By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Percentage of participants|||Number
56693|NCT01245439|Secondary|Percentage of Participants Who Achieved Remission (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.||percentage of participants|||Number
56694|NCT01245439|Secondary|Number of Participants Who Achieved Remission (DAS28) By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category||participants|||Number
56702|NCT01245439|Secondary|Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)|ANC is a measure of number of neutrophil granulocytes. An ANC less than 500 cells per microliter (cells/µL) is defined as neutropenia and significantly increases risk of infection. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline. ANC was measured in cells/µL.|Baseline to Week 24|Safety population||cells/µL||Standard Deviation|Mean
56703|NCT01245439|Secondary|Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol|Elevations in LDL and total cholesterol could lead to heart disease. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline and was measured as milligrams per deciliter (mg/dL).|Baseline to Week 24|Safety population; number of participants analyzed signifies participants who were evaluable for this outcome.||mg/dL||Standard Deviation|Mean
56695|NCT01245439|Secondary|Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome||Percentage of participants|||Number
56696|NCT01245439|Secondary|Percentage of Participants Who Achieved LDA By Visit|"TThe DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.||percentage of participants|||Number
56697|NCT01245439|Secondary|Number of Participants Who Achieved LDA By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.||participants|||Number
56698|NCT01245439|Secondary|Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: < 3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.||percentage of participants|||Number
56699|NCT01245439|Secondary|Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of less than (<) 2.6 represents clinical remission, a score of: <3.2 represents low disease activity (LDA), and a score of > 5.1 represents severe disease. A reduction from previous visit of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Intent- to- Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category||participants|||Number
56700|NCT01245439|Secondary|Percentage of Participants With Elevations in Lipids According to ATP III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL , Total cholesterol >240 mg/dL, HDL >60 mg/dL and TG >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; n = number of participants analyzed at the specified visit for the given parameter.||percentage of participants|||Number
56704|NCT01245439|Secondary|Change From Baseline to Highest Values for ALT and AST|Elevations in ALT and AST could indicate hepatotoxicity. These enzymes were measured as International Units per Liter (IU/L). The change from baseline was calculated as: baseline value minus the highest value observed post-baseline for each enzyme.|Baseline to Week 24|Safety population||IU/L||Standard Deviation|Mean
56706|NCT01245439|Secondary|Percentage of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population||percentage of participants|||Number
56707|NCT01245439|Secondary|Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population||percentage of participants|||Number
56708|NCT01245439|Secondary|Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population||participants|||Number
56709|NCT01245439|Secondary|Percentage of Participants With All-Cause Discontinuation|Participants who discontinued treatment due to any reason were included in this measure.|24 weeks|Safety population||percentage of participants|||Number
56710|NCT01245439|Primary|Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.|24 weeks|The safety population consisted of all participants included in the study who received at least one dose of study medication and who had at least one post-baseline assessment of safety (that is post-baseline laboratory data, vital signs or adverse events).||percentage of participants|||Number
56711|NCT01245413|Primary|Visual Inspection of Baseplate Loosening|The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm^2|1 hour|ITT||cm^2||Standard Deviation|Mean
56712|NCT01245387|Other Pre-specified|IOP Mean Difference (Within a Participant)|Average predose minus postdose mean difference in IOP within a participant|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.||mmHg||Standard Deviation|Mean
56713|NCT01245387|Other Pre-specified|Change in IOP Between Predose and Postdose Assessment|IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||mmHg||Standard Deviation|Mean
56714|NCT01245387|Other Pre-specified|Intraocular Pressure (IOP)|IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||mmHg||Standard Deviation|Mean
56715|NCT01245387|Other Pre-specified|Treatment Tolerability|Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.|Month 24 or early termination|Safety Set; N=number of participants with evaluable data.||Participants|||Number
56716|NCT01245387|Other Pre-specified|Number of Participants With Complications Associated With Injection|Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.|Baseline up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.||Participants|||Number
56717|NCT01245387|Other Pre-specified|Time to First Adverse Event (AE)|Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.|Baseline up to Month 24 or early termination|Safety Set: all participants who received at least 1 Macugen (pegaptanib) injection and provided data post baseline. Data not analyzed due to low number of AEs.||Days||95% Confidence Interval|Median
56718|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Last Visit|Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.||Participants|||Number
56719|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 54|Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 54|FAS; N=number of participants with evaluable data.||Participants|||Number
56736|NCT01245387|Primary|Number of Participants With PED at Week 24|PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 24|FAS; N=number of participants with evaluable data.||Participants|||Number
56720|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 48|Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 48|FAS; N=number of participants with evaluable data.||Participants|||Number
56721|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 42|Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 42|FAS; N=number of participants with evaluable data.||Participants|||Number
56722|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 36|Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 36|FAS; N=number of participants with evaluable data.||Participants|||Number
56723|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 30|Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 30|FAS; N=number of participants with evaluable data.||Participants|||Number
56724|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 24|Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 24|FAS; N=number of participants with evaluable data.||Participants|||Number
56725|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 18|Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 18|FAS; N=number of participants with evaluable data.||Participants|||Number
56726|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 12|Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 12|FAS; N=number of participants with evaluable data.||Participants|||Number
56727|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 6|Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 6|FAS;N=number of participants with evaluable data.||Participants|||Number
56728|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Baseline|Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Baseline|FAS; N=number of participants with evaluable data.||Participants|||Number
56729|NCT01245387|Primary|Central Retinal Thickness|Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||Micrometers (Mcm)||Standard Deviation|Mean
56730|NCT01245387|Primary|Number of Participants With PED at Last Visit|PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.||Participants|||Number
56731|NCT01245387|Primary|Number of Participants With PED at Week 54|PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 54|FAS; N=number of participants with evaluable data.||Participants|||Number
56732|NCT01245387|Primary|Number of Participants With PED at Week 48|PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 48|FAS; N=number of participants with evaluable data.||Participants|||Number
56733|NCT01245387|Primary|Number of Participants With PED at Week 42|PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 42|FAS; N=number of participants with evaluable data.||Participants|||Number
56734|NCT01245387|Primary|Number of Participants With PED at Week 36|PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 36|FAS; N=number of participants with evaluable data.||Participants|||Number
56735|NCT01245387|Primary|Number of Participants With PED at Week 30|PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 30|FAS; N=number of participants with evaluable data.||Participants|||Number
56741|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit|Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.||Participants|||Number
56742|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 72|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 72|FAS; N=number of participants with evaluable data.||Participants|||Number
56743|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 66|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 66|FAS; N=number of participants with evaluable data.||Participants|||Number
56744|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 60|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 60|FAS; N=number of participants with evaluable data.||Participants|||Number
56745|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 54|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 54|FAS; N=number of participants with evaluable data.||Participants|||Number
56746|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 48|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 48|FAS; N=number of participants with evaluable data.||Participants|||Number
56747|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 42|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 42|FAS; N=number of participants with evaluable data.||Participants|||Number
56748|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 36|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 36|FAS; N=number of participants with evaluable data.||Participants|||Number
56749|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 30|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 30|FAS; N=number of participants with evaluable data.||Participants|||Number
56750|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 24|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 24|FAS; N=number of participants with evaluable data.||Participants|||Number
56751|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 18|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 18|FAS; N=number of participants with evaluable data.||Participants|||Number
56752|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 12|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 12|FAS; N=number of participants with evaluable data.||Participants|||Number
56753|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 6|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 6|FAS; N=number of participants with evaluable data.||Participants|||Number
56754|NCT01245387|Primary|Lesion Size (Number of Optic Disc Areas)|Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||number of optic disc areas||Standard Deviation|Mean
56755|NCT01245387|Primary|Number of Participants With Investigator Assessments of Efficacy|Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.|Month 24 or early termination|FAS; N = number of participants with evaluable data.||Participants|||Number
61190|NCT01195090|Secondary|Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Baseline HOMA-IR|Baseline HOMA-IR|Baseline HOMA-IR||HOMA-IR score||Standard Deviation|Mean
56756|NCT01245387|Primary|Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score|Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, every 6 months up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.||Scores on a scale||Standard Deviation|Mean
56757|NCT01245387|Primary|Visual Acuity (VA)|VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.||lines of VA||Standard Deviation|Mean
56758|NCT01245374|Secondary|Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial||Weeks 0 - 6|The safety set consisted of all participants included in the trial and having taken at least one dose of trial treatment. The adverse events and technical complaints were collected during the treatment period (6 weeks after inclusion).||participants|||Number
56759|NCT01245374|Secondary|Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment|The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For two patients, no data available.||percentage of participants|||Number
56760|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
56761|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
56762|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
56763|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Time Learning|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.||percentage of participants|||Number
56764|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Ease of Training|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
56765|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.||percentage of participants|||Number
56766|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.||percentage of participants|||Number
56767|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.||percentage of participants|||Number
57028|NCT01242813|Secondary|Percentage of Participants Who Relapsed and Received Rescue Medication|Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication.|Day 85 to Day 953 (End of treatment period to End of study)|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
56768|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|"Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.~For one patient, no data available."||percentage of participants|||Number
56769|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
56770|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.||percentage of participants|||Number
56771|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For seven patients, no data available.||percentage of participants|||Number
56772|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||percentage of participants|||Number
56773|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Per protocol set (PP): All subjects in the ITT set using NordiFlex® and had completed the trial without any significant violation of the inclusion/exclusion criteria or any other aspect of the protocol considered to potentially affect the efficacy results.||units on a scale||Standard Deviation|Mean
56774|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.||units on a scale||Standard Deviation|Mean
56775|NCT01245283|Secondary|Seated Row Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
56776|NCT01245283|Secondary|Shoulder Press Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
56777|NCT01245283|Secondary|Chest Press; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
56778|NCT01245283|Secondary|Leg Curl Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
56779|NCT01245283|Secondary|Leg Extensions Test; Change From Baseline at 4 Months|Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
56780|NCT01245283|Secondary|Leg Press Test; Change From Baseline at 4 Months|Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.|Baseline, 4 Months|||foot x pounds||Standard Deviation|Mean
56781|NCT01245283|Secondary|Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months|Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.|Baseline, 4 Months|||Seconds||Standard Deviation|Mean
57599|NCT01235715|Primary|Drain Output|A measurement of the amount of blood drained from the knee.|24 hours post-operatively|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons||mL||Standard Error|Mean
56782|NCT01245283|Secondary|Six Minute Walk Test; Change From Baseline at 4 Months|Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.|Baseline, 4 Months|||feet||Standard Deviation|Mean
56783|NCT01245283|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months|"The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status.~Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible).~0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)"|Baseline, 4 Months|||units on a scale||Standard Deviation|Mean
56784|NCT01245270|Secondary|Bioavailability in Urine|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Urine will also be collected (if possible) 0, 1, 3 and 5 hours, with all urine collected within the 24 hour time period post intervention||02/2017||||
56785|NCT01245270|Secondary|Bioavailability in Plasma|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Plasma will also be collected -15,-10, -5, 15, 30, 45, 60, 90, 120, 150, and 300 minutes and 24 hours post intervention||02/2017||||
56786|NCT01245270|Primary|Plasma Insulin iAUC (Incremental Area Under the Curve; ng/ml*Min)|"Volunteers were fasted (10–12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at –15, –10 and –5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61•9%; polysaccharide, 49•2~%; sugars, 12•2%; glucose, 0•6%; maltose, 11•6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.~For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after the capsule|||insulin iAUC (ng/ml*min)||Standard Error|Mean
56787|NCT01245270|Primary|Plasma Glucose iAUC (Incremental Area Under the Curve; mM*Min)|"Volunteers were fasted (10–12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at –15, –10 and –5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61·9%; polysaccharide, 49·2~%; sugars, 12·2%; glucose, 0·6%; maltose, 11·6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.~For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post capsule|||glucose iAUC (mM*min)||Standard Error|Mean
56788|NCT01245101|Secondary|Markers of Immune Activation|Flow cytometry will be performed in whole blood for analysis of markers of immune activation by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD8+CD38+ cells will be determined as the main outcome measure.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.||Percentage of activated CD8+CD38+ cells||Standard Deviation|Mean
56789|NCT01245101|Primary|Episomal HIV cDNA Formation|These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.||copies/million||Standard Deviation|Mean
56790|NCT01245062|Secondary|PFS Following Cross-over to Trametinib as Assessed by the Investigator|PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 2.72 months)|Cross-over Population||Months||95% Confidence Interval|Median
56791|NCT01245062|Secondary|DR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator|DR is defined as the time from the first documented evidence of CR (disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DR data were summarized per RECIST, Version 1.1.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 2.72 months)|Cross-over Population. Only those participants with confirmed response (CR and PR) were analyzed.||Months||95% Confidence Interval|Median
56812|NCT01244984|Secondary|Change From Baseline in Heart Rate (HR)|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Beats/Minute||Standard Deviation|Mean
56792|NCT01245062|Secondary|DR for All Confirmed Responders (CR or PR) as Assessed by the Investigator or Independent Review|DR is defined as thetime from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DR for the INVA and INDA response data was summarized per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|"ITT Population. Only those participants with confirmed response (CR and PR) were analyzed. The n in the category title reflects the number of participants with a confirmed response assessed by the Investigator and by Independent Review. The same participants were not necessarily assessed by both."||Months||95% Confidence Interval|Median
56793|NCT01245062|Secondary|Duration of Response (DR) for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classifed as Confirmed Responders (CR or PR) as Assessed by the Investigator and Independent Review|DR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DR for the investigator-assessed (INVA) and independently-assessed (INDA) response data were summarized per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|"Primary Efficacy Population. Only those participants (par.) with a confirmed response (CR and PR) were analyzed. The n in the category title reflects the par. assessed by the Investigator and by Independent Review; the same par. were not necessarily assessed by both."||Months||95% Confidence Interval|Median
56794|NCT01245062|Secondary|Number of Participants With OR Following Cross-over to Trametinib|OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 2.72 months)|Cross-over Population: the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.||Participants|||Number
56795|NCT01245062|Secondary|Number of BRAF V600K Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population: only those participants withV600K mutation-positive melanoma were assessed.||Participants|||Number
56796|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population: only those participants withV600E mutation-positive melanoma were assessed.||Participants|||Number
56797|NCT01245062|Secondary|Number of Participants With OR as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population||Participants|||Number
56798|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Without a History of Brain Metastases With Overall Response (OR) as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population||participants|||Number
56799|NCT01245062|Secondary|Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Day 1 until death due to any cause (average of 4.8 months)|Primary Efficacy Population||Months||95% Confidence Interval|Median
56800|NCT01245062|Secondary|Overall Survival in All Participants|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Day 1 until death due to any cause (average of 4.8 months)|ITT Population||Months||95% Confidence Interval|Median
56801|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population. Only those participants with prior chemotherapy were analyzed.||Months||95% Confidence Interval|Median
56802|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population. Only those participants without prior chemotherapy were analyzed.||Months||95% Confidence Interval|Median
56803|NCT01245062|Secondary|Progression-free Survival in All Participants|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|ITT Population: all randomized participants regardless of whether or not treatment was administered||Months||95% Confidence Interval|Median
56804|NCT01245062|Primary|Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)|Primary Efficacy Population: All participants with BRAF V600E mutation-positive melanoma without a history of brain metastases||Months||95% Confidence Interval|Median
56805|NCT01244984|Secondary|Number of Rescue Medication Inhalations|Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening).|Baseline up to Week 52|ITT Population. The number of participants analyzed depends on the number of participants remaining in the indaicated time period.||Number of inhalations||Standard Deviation|Mean
56806|NCT01244984|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population||Percentage of rescue free 24-hour period||Standard Deviation|Mean
56807|NCT01244984|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment|Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population||Percentage of symptom-free days||Standard Deviation|Mean
56808|NCT01244984|Secondary|Change From Baseline in Asthma Symptom Score During the Study Treatment|The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping.|Baseline up to Week 52|ITT Population||Scores on a scale||Standard Deviation|Mean
56809|NCT01244984|Secondary|Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment|Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated.|Baseline up to Week 52|ITT Population||Litres per Minute (L/min)||Standard Deviation|Mean
56810|NCT01244984|Secondary|Number of Participants With Severe Asthma Exacerbation During the Study Treatment|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|Baseline up to Week 52|ITT Population||Participants|||Number
56811|NCT01244984|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline[Week -2], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS.|Week 12, Week 24, and Week 52/WD|"ITT Population. . Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
61191|NCT01195090|Secondary|Baseline High Sensitive C-reactive Protein|Baseline high sensitive C-reactive Protein|baseline|Baseline high sensitive C-reactive Protein||mg/dl||Standard Deviation|Mean
56813|NCT01244984|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
56814|NCT01244984|Secondary|Change From Baseline in the 24-hour Urinary Cortisol Excretion|Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline (Week 0), Week 24, and Week 52/WD|Urine cortisol (UC) Population: all participants in the ITT Population from whom urine specimens were collected and who were considered not to have any confounding factors that might affect the analysis of the results of the specimens. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
56815|NCT01244984|Secondary|Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
56816|NCT01244984|Secondary|Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||ratio of urine density to water density||Standard Deviation|Mean
56817|NCT01244984|Secondary|Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||pH||Standard Deviation|Mean
56818|NCT01244984|Secondary|Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
56819|NCT01244984|Secondary|Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Micromoles per Liter (µmol/L)||Standard Deviation|Mean
56820|NCT01244984|Secondary|Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||International unit per liter (IU/L)||Standard Deviation|Mean
56821|NCT01244984|Secondary|Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||g/L||Standard Deviation|Mean
56880|NCT01244620|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||hours||Full Range|Median
58791|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device|Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.|30 days|||% of procedures achieving hemostasis|Participants||Number
56822|NCT01244984|Secondary|Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||10^12 per liter (Ti/L)||Standard Deviation|Mean
56823|NCT01244984|Secondary|Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Proportions of I||Standard Deviation|Mean
56824|NCT01244984|Secondary|Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Grams per liter (g/L)||Standard Deviation|Mean
56825|NCT01244984|Secondary|Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||10^9 per liter (Gi/L)||Standard Deviation|Mean
56826|NCT01244984|Secondary|Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Percentage||Standard Deviation|Mean
56827|NCT01244984|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAE.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period||Participants|||Number
56828|NCT01244906|Secondary|Number of Patients With Overall Survival at 2 Years.||2 years|||participants|||Number
56829|NCT01244906|Secondary|Number of Patients to Achieve Full Donor Chimerism|Characterize rate of achievement of full donor chimerism|1 year|||participants|||Number
56830|NCT01244906|Secondary|Number of Patients With Disease Free Survival at 2 Years||2 years|||participants|||Number
56831|NCT01244906|Secondary|Number of Participants With Non-Relapse Mortality||1 year|||participants|||Number
56832|NCT01244906|Secondary|Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment|To estimate the incidence of neutrophil and platelet engraftment|Approximately Day 30|||participants|||Number
56833|NCT01244906|Primary|Incidence of GVHD|To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.|1 year|||participants|||Number
56834|NCT01244893|Secondary|Bulbar Redness|Scale of 0 increasing to 4. 0=None, 4=Severe Redness|6-8 days after lens wear|Population analyzed consisted of those who were enrolled, randomized, and completed the study.||units on a scale||Standard Deviation|Mean
56835|NCT01244893|Secondary|Limbal Redness|Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.||units on a scale||Standard Deviation|Mean
56836|NCT01244893|Secondary|Corneal Staining|Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.||units on a scale|Participants|Standard Deviation|Mean
56837|NCT01244893|Primary|Visual Acuity (VA)|Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.||logMAR scale||Standard Deviation|Mean
56881|NCT01244529|Secondary|New Lens Power Fit Match to Control Lenses|The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||percentage of eyes|Participants||Number
56838|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Final Assessment|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.|Baseline up to Week 52|Participants who received at least one dose of study drug and had a baseline and at least one post-baseline PANSS measurement.||score on a scale||Standard Error|Mean
56839|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Week 52|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 PANSS measurement.||score on a scale||Standard Error|Mean
56840|NCT01244828|Primary|Change From Baseline in Prolactin at Week 52|Blood samples for determination of prolactin level were obtained at baseline and during the study. For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||µg/L||Standard Deviation|Mean
56841|NCT01244828|Primary|Change From Baseline in Insulin at Week 52|Blood samples for determination of insulin level were obtained at baseline and during the study. For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||µIU/mL||Standard Deviation|Mean
56842|NCT01244828|Primary|Change From Baseline in Fasting Glucose at Week 52|Blood samples for determination of fasting glucose level were obtained at baseline and during the study. For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||mmol/L||Standard Deviation|Mean
56843|NCT01244828|Primary|Change From Baseline in HbA1c at Week 52|Blood samples for determination of HbA1c were obtained at baseline and during the study. For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||percent||Standard Deviation|Mean
56844|NCT01244828|Primary|Number of Participants With Extrapyramidal Symptoms|This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for “extrapyramidal syndrome” were treated as extrapyramidal symptoms.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|Participants who received at least one dose of study drug.||participants|||Number
56845|NCT01244828|Primary|Change From Baseline in BMI at Week 52|For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||kg/m^2||Standard Deviation|Mean
56846|NCT01244828|Primary|Change From Baseline in Weight at Week 52|For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.||kg||Standard Deviation|Mean
56847|NCT01244815|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q overall score must be available for a participant.||score on a scale||Standard Deviation|Mean
56882|NCT01244529|Primary|Fit Acceptability|Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||percentage of eyes|Participants||Number
58792|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device|Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device|30 days|||% of procedures using closure device|Participants||Number
56848|NCT01244815|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q total score must be available for a participant.||score on a scale||Standard Deviation|Mean
56849|NCT01244815|Secondary|Change From Baseline in Children’s Global Assessment Scale (CGAS) Score at Day 21|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 21; improvement in functioning is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of CGAS score must be available for a participant.||score on a scale||Standard Deviation|Mean
56850|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 21|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CDRS-R total score must be available for a participant.||score on a scale||Standard Deviation|Mean
56851|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 14|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CDRS-R total score must be available for a participant.||score on a scale||Standard Deviation|Mean
56852|NCT01244815|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score at Day 7|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CDRS-R total score must be available for a participant.||score on a scale||Standard Deviation|Mean
56853|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
56854|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
61192|NCT01195090|Secondary|Baseline Fasting Plasma Glucose|Baseline fasting plasma glucose|baseline|Baseline fasting plasma glucose||mg/dl||Standard Deviation|Mean
56855|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
56856|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP depression score must be available for a participant.||score on a scale||Standard Deviation|Mean
56857|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
56858|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
56859|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
56860|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP mania score must be available for a participant.||score on a scale||Standard Deviation|Mean
56861|NCT01244815|Secondary|Total Y-MRS 50% Responders at Days 4, 7, 14 and 21|A total Y-MRS 50% responder was defined as a participant who had a reduction from baseline to the identified study visit of at least 50% in the Y-MRS total score. The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items, based on the participant’s subjective report of his or her condition over the previous 48 hours and the clinician’s observations during the interview, with the emphasis on the latter. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60 with higher scores indicating greater severity of symptoms. This analysis used a Last-Observation-Carried-Forward (LOCF) approach; if at a given visit no Y-MRS total score was available for determining whether a participant was a responder, the last available post-baseline on-treatment assessment prior to that visit was used.|Baseline and Days 4, 7, 14 and 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included for a visit, a Y-MRS total score must be available for that visit or a prior post-baseline on-treatment visit||participants|||Number
56883|NCT01244529|Primary|Primary Gaze Lens Movement|Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||percentage of eyes|Participants||Number
57315|NCT01239316|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months|||participants|||Number
56862|NCT01244815|Secondary|Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21|Change from baseline in CGI-BP overall score at Day 21 is the Key Secondary Outcome Measure. The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the participant’s overall bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP overall score must be available for a participant.||score on a scale||Standard Deviation|Mean
56863|NCT01244815|Primary|Change From Baseline in Y-MRS Total Score at Day 21|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant’s subjective report of his or her condition over the previous 48 hours and the clinician’s observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 21 value of Y-MRS total score must be available for a participant.||score on a scale||Standard Deviation|Mean
56864|NCT01244724|Secondary|National Hospital Seizure Severity Scale||12 weeks||||||
56865|NCT01244724|Primary|Hamilton Depression Scale|Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)|12 weeks|||units on a scale||Standard Deviation|Mean
56866|NCT01244711|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).|12 weeks|Change in total score on the MADRS from baseline to final visit||units on a scale|||Number
56867|NCT01244633|Secondary|Columbia Scale for Suicide Risk|This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.|Every 7 days||||||
56868|NCT01244633|Secondary|Safety Assessments|Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.|Every 7 days||||||
56869|NCT01244633|Secondary|Clinician Global Impression – Improvement and Severity Scales (CGI)|This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.|End of trial||||||
56870|NCT01244633|Secondary|Premonitory Urge for Tics Scale (PUTS-1)|This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.|Every 7 days||||||
56871|NCT01244633|Secondary|Hamilton Depression Scale|This is a measure of feelings of depression that the patient might have.|Every 7 days||||||
56872|NCT01244633|Secondary|Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)|This is a standard measure of ADHD severity that is typically used in these types of clinical trials.|Every 7 days||||||
56873|NCT01244633|Primary|Yale Global Tic Severity Score|The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.|8 weeks|Subjects completing the study||units on a scale||Standard Deviation|Mean
56874|NCT01244620|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||Liter (L)||Standard Deviation|Geometric Mean
56875|NCT01244620|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||hours||Standard Deviation|Mean
56876|NCT01244620|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||mL/minute||Standard Deviation|Geometric Mean
56877|NCT01244620|Primary|Area Under the Curve of the 24 Hour Dosing Interval (AUC24)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
56878|NCT01244620|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||micrograms per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
56879|NCT01244620|Primary|Trough Plasma Concentrations (Ctrough)|Minimum or “trough”concentrations|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.||nanograms (ng)/milliliter (mL)||Standard Deviation|Geometric Mean
56884|NCT01244529|Primary|Lens Centration Acceptance|Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.||eyes|Participants||Number
56885|NCT01244516|Secondary|Overall Subjective Lens Handling|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol.||CLUE score||Standard Error|Least Squares Mean
56886|NCT01244516|Primary|Corneal Staining|Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).||percentage of eyes|Participants||Number
56887|NCT01244516|Primary|Overall Subjective Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).||CLUE score||Standard Error|Least Squares Mean
56888|NCT01244503|Secondary|Histology -NAS Scoring of Liver Biopsy|"OBT will be compared to histology (including NAS score as described above)and other parameters to develop severity score. Only subjects with biopsy from routine clinical practice will be enrolled.~NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system includes the following components: steatosis, which is scaled from 0-3, lobular inflammation, which is scaled from 0-3 and hepatocellular ballooning, which is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The range of the NAS score is from 0-8."|Up to 6 months|||units on a scale||Standard Deviation|Mean
56889|NCT01244503|Primary|The Peak Value of the PDR (Percentage Dose Recovery of 13C) of OBT (Octanoate Breath Test)|To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD (non alcoholic fatty liver disease) compared to NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system, where steatosis is scaled from 0-3, lobular inflammation is scaled from 0-3 and hepatocellular ballooning is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The higher the PDR peak, the better the liver health and function.PDR units are percent per hour of 13C dose recovery and describes rate of metabolism. The PDR peak is the highest rate of metabolism the liver reaches.The total range of NAS is 0-8.|1 hour|||PDR peak value (%/hour)||Standard Deviation|Mean
56890|NCT01244490|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|SP||participants|||Number
56891|NCT01244490|Secondary|Structure Side-Effect Questionnaire|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking ‘yes’ on the checklist for each of the events listed. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|Safety Population||participants|||Number
56892|NCT01244490|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Safety Population defined as of randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
56893|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF|The WFIRS-P Risk Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56894|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF|The WFIRS-P Social Domain is the mean of 7 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56895|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF|The WFIRS-P Child Self-Concept Domain is the mean of 3 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56896|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF|The WFIRS-P Life Skills Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56897|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF|The WFIRS-P Behavior in School Domain is the mean of 6 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56898|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF|The WFIRS-P Academic Performance Domain is the mean of 4 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56899|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF|The WFIRS-P Global Score is the mean of 50 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56900|NCT01244490|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.||units on a scale||Standard Deviation|Mean
56901|NCT01244490|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.||percentage of participants|||Number
56902|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF|The WFIRS-P Family Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56903|NCT01244490|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF|The WFIRS-P Learning in School Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.||units on a scale||Standard Error|Least Squares Mean
56904|NCT01244490|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.||percentage of participants|||Number
56905|NCT01244490|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of investigational product. If more than 20% of the items used for summing a score were missing, the score was set to missing.||units on a scale||Standard Error|Least Squares Mean
56906|NCT01244477|Secondary|PTSD Checklist (PCL)|An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.|Administered each week at weekly group sessions or pre-post treatment as usual|Veterans under 50 years of age diagnosed with PTSD||PCL Scores||Standard Deviation|Mean
56997|NCT01243320|Primary|Change In Glucose Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
94428|NCT00860470|Secondary|Preterm Birth|Risk of being born before 37 weeks of gestation|December 2014|||participants|||Number
56907|NCT01244477|Secondary|Behavioral Expression of Trust on the Trust Game|The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.|Pre & post a 12 week treatment group|Veterans with PTSD under 50 years of age||Ratio||Standard Deviation|Mean
56908|NCT01244477|Primary|The Clinician Administered PTSD Scale (CAPS)|The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.|Pre & post a 12 week treatment group|We limited this arm to 18 subjects who completed 9+ out of 12 treatment sessions.||CAPS Scores||Standard Deviation|Mean
56909|NCT01244477|Primary|Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan||Pre & post a 12 week treatment group||||||
56910|NCT01244425|Secondary|Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery||Within 48 hours after surgery|"Full analysis (data) set~Participants who received a drain and for whom the volume for the first 48 hours after surgery is available"||mL||Full Range|Median
56911|NCT01244425|Secondary|Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward|Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.|Intra- and postoperative until discharged from surgical ward|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
56912|NCT01244425|Secondary|Percentage of Participants With Postoperative Rebleeding|Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration|Postoperative until discharged from surgical ward|Full analysis (data) set||Percentage of participants||95% Confidence Interval|Number
56913|NCT01244425|Secondary|Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis|Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.|Intraoperative day 0|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
56914|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|10 minutes after start of treatment application|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
56915|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|8 minutes after start of treatment application|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
56916|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|6 minutes after start of treatment application|Full analysis (data) set||percentage of participants||95% Confidence Interval|Number
56917|NCT01244425|Primary|Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application|"Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.~The following were regarded as treatment failures:~No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the “time to hemostasis” was used; a time window of +5 seconds was acceptable for showing a success)~Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required~Reapplication of FS VH S/D 500 s-apr after 4 minutes~Intraoperative rebleeding after the first 4 minutes of the observation period"|4 minutes post start of treatment application|full analysis (data) set (FAS)||percentage of participants||95% Confidence Interval|Number
56918|NCT01244412|Primary|Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera|"Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher.~Scale Image scored as follows~Unacceptable: cannot see fundus detail~Unacceptable: fundus detail visualized, but inadequate for meaningful analysis~Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use~Good: fundus detail visualized, meaningful analysis possible, std photo superior~Excellent: fundus detail visualized as well as std photo~Superior: fundus detail of higher quality than std photo"|estimated 3 months|||participants|||Number
56998|NCT01243320|Primary|Change In CreatinineBlood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
56999|NCT01243320|Primary|Change in Urea Nitrogen Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
56919|NCT01244243|Primary|Arm Motor Fugl-Meyer Test|The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.|change from baseline to 1 month post-end treatment, Intention To Treat|||units on a scale||95% Confidence Interval|Mean
56920|NCT01244243|Primary|Action Research Arm Test|The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.|change from baseline to 1 month post-end treatment, Intention To Treat|||units on a scale||95% Confidence Interval|Mean
56921|NCT01244126|Secondary|Maximum PAED Score|"Maximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium.~1. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20."|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|The sample size was based on the assumption that the pain scores in the intranasal fentanyl group would be similar to those in previously published data||units on a scale||Standard Deviation|Mean
56922|NCT01244126|Primary|Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.|FLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65)|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|Analysis was performed on per protocol basis excluding patients with protocol violations||units on a scale||Standard Deviation|Mean
56923|NCT01244061|Secondary|7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52|The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the “last 7 days” questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit.|Weeks 12, 24 and 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
56924|NCT01244061|Secondary|CAR From Week 9 Through Week 24|The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 24|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
56925|NCT01244061|Secondary|CAR From Week 9 Through Week 52|The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
56926|NCT01244061|Primary|Continuous Abstinence Rate (CAR) From Week 9 Through Week 12|The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.|Week 9 through Week 12|The Full Analysis Set (FAS) included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.||Percentage of participants|||Number
56927|NCT01243944|Secondary|Estimated Duration of the Complete Hematological Remission|"Duration of the complete hematological remission is defined as the time from the first occurrence of complete hematological remission until the date of the first documented progression (end of response).~Kaplan-Meier estimates are provided for duration of complete hematological remission."|Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.||probability||95% Confidence Interval|Number
56928|NCT01243944|Secondary|The Percentage of Subjects Achieving a Durable Complete or Partial Clinicohematologic Response at Week 48|Durable Complete or Partial Clinicohematologic Response was defined as any subject who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants|||Number
56929|NCT01243944|Secondary|The Percentage of Subjects Who Achieved Overall Clinicohematologic Response at Week 32|Overall Clinicohematologic Response is defined as any subject who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria.|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants|||Number
56930|NCT01243944|Secondary|Estimated Duration of the Primary Response|"Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response).~Kaplan-Meier estimates are provided for duration of primary response."|Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.||probability||95% Confidence Interval|Number
56931|NCT01243944|Secondary|The Percentage of Subjects Who Achieved Durable Spleen Volume Reduction at Week 48|Durable Spleen Volume Reduction was defined as a subject who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
56932|NCT01243944|Secondary|The Percentage of Subjects Who Achieved a Durable Hematocrit Control at Week 48|Durable Hematocrit Control was defined as any subject who achieved phlebotomy eligibility independence from Week 8 to Week 32 and maintained hematocrit control up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
56933|NCT01243944|Secondary|The Percentage of Subjects Who Achieved a Durable Complete Hematological Remission at Week 48|Durable Complete Hematological Remission was defined as any subject who achieved Complete Hematological Remission at Week 32 and maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
56934|NCT01243944|Secondary|The Percentage of Subjects Achieving Complete Hematological Remission at Week 32|Complete Hematological Remission at Week 32 was defined as any subject who achieved hematocrit control with a platelet count less than or equal to 400 X 10^9/L and a white blood cell count less than or equal to 10 X 10^9/L.|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
56935|NCT01243944|Secondary|The Percentage of Subjects Achieving a Durable Primary Response at Week 48|Durable Primary Response was defined as any subject who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
56936|NCT01243944|Primary|The Percentage of Subjects Achieving a Primary Response at Week 32|Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32).|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.||percentage of participants||95% Confidence Interval|Number
56937|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy|The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 – height in cm at t12) divided by (date at t24 – date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.|Month 12 to Month 24 (Year 1 to Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.|||||
56938|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment|The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 – height in cm at t0) divided by (date at t12 – date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.|Baseline up to Month 12 (Year 1)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.|||||
56939|NCT01243892|Primary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment|The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (–) height in cm at t0) divided by (date at t24 – date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.|Baseline up to Month 24 (Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.|||||
56940|NCT01243775|Secondary|Neutropenia Grade 3-4|Toxicity (CECAE ver 4.0) and Safety|2 years|||participants|||Number
56941|NCT01243775|Secondary|Overall Survival||2 years|||months||95% Confidence Interval|Median
56942|NCT01243775|Secondary|Progression Free Survival||2 years|||months||95% Confidence Interval|Median
56943|NCT01243775|Primary|Response Rate|RECIST version 1.1|6th week|Intention to treat population||participants|||Number
56944|NCT01243671|Secondary|Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52|C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.||mg/dL||Standard Deviation|Mean
56945|NCT01243671|Secondary|Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.||units on a scale||Standard Deviation|Mean
57000|NCT01243320|Primary|Change in Carbon Dioxide Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
57001|NCT01243320|Primary|Change in Chloride Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
56946|NCT01243671|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.||units on a scale||Standard Deviation|Mean
56947|NCT01243671|Secondary|Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52|Investigators assessed oral aphthous (mouth ulcers), skin symptoms, eye symptoms and vulval (genital) ulcers during 4 weeks before study visit via participant interview, using the following grades. Oral aphthous: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Skin (Erythema nodosum rash): 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Eye (Uveitis): 0=None; 1=one eye crisis in recent 4 weeks; 2=two eye crises in recent 4 weeks; 3=three eye crises in recent 4 weeks. Vulval (genital) ulcer: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Resolution was defined as: Behçet's disease symptoms other than gastrointestinal symptoms were graded 0 (disappeared).|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.||participants|||Number
56948|NCT01243671|Secondary|Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Participants assessed their abdominal pain, diarrhea and other gastrointestinal symptoms (abdominal discomfort, abdominal fullness, etc) during 2 weeks before assessment visit in 5 grades. Investigator confirmed the assessment through interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Improvement of ≥1 grade from baseline is also presented.|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.||participants|||Number
56949|NCT01243671|Secondary|Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52|Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
56950|NCT01243671|Secondary|Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Study participants completed a global assessment of their gastrointestinal symptoms (Behçet’s disease symptoms other than gastrointestinal symptoms were excluded) during 2 weeks before assessment visit on a 5-grade scale. The investigator confirmed this assessment via interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Global assessment of grade 0 or ≤1 and improvement of ≥1 (from baseline) is presented.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
56951|NCT01243671|Secondary|Number of Participants With Complete Remission at Week 24 and Week 52|Complete remission was defined as both endoscopic improvement and global assessment of gastrointestinal symptoms grades of 0. Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
56952|NCT01243671|Secondary|Number of Participants With Marked Improvement at Week 52|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
57002|NCT01243320|Primary|Change in Potassium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
94429|NCT00860470|Secondary|Still Birth Rates|Risk of Still birth|December 2014|||participants|||Number
56953|NCT01243671|Primary|Number of Participants With Marked Improvement at Week 24|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.||participants|||Number
56954|NCT01243619|Other Pre-specified|Analyze Correlation Between FDG and FLT PET Scans, and the Correlation Between Both Types of PET Scan and the Response to Treatment.|We will compare the findings of FDG and FLT PET scans at pre-treatment, mid-treatment and post-treatment time points to determine how closely they correlate with each other, and if there is a specific time point at which any observed differences between FDG and FLT PET scans are most pronounced. We will also determine which of the six PET scans may correlate most closely with the response to treatment as determined by pathologic findings at esophagectomy.|1 year||||||
56955|NCT01243619|Primary|Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis|Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.|1 year|||participants|||Number
56956|NCT01243567|Secondary|Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
56957|NCT01243567|Secondary|Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
56958|NCT01243567|Secondary|Percentage of Patients Reaching a Predefined Target Pressure Threshold|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.|Baseline, Month 3|Intent to Treat: all randomized patients.||Percentage of Patients|||Number
56959|NCT01243567|Secondary|Change From Baseline IOP|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
56960|NCT01243567|Primary|Change From Baseline in Average Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
56961|NCT01243450|Primary|Acne Lesion Percent Reduction|Reduction in number of Acne lesions by counting over 12 weeks|12 week|||percent reduction of number of lesions||Standard Deviation|Mean
56962|NCT01243411|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.||centimeters||Standard Deviation|Mean
56963|NCT01243411|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.||participants|||Number
56964|NCT01243411|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
56965|NCT01243411|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
56966|NCT01243411|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.||participants|||Number
57003|NCT01243320|Primary|Change in Sodium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mmol/L||95% Confidence Interval|Mean
63557|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)||10-14 weeks|||% of participants|||Number
56967|NCT01243411|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
56968|NCT01243411|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
56969|NCT01243411|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
56970|NCT01243411|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on the modified intent-to-treat (mITT) population.||percentage of curvature change||Standard Deviation|Mean
56971|NCT01243320|Primary|Change in Quinone Oxidoreductase 1 Gene|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
56972|NCT01243320|Primary|Change in Monocyte Chemotactic Protein 1|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
56973|NCT01243320|Primary|Change to Interleukin-1 Beta Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
56974|NCT01243320|Primary|Change to Interleukin-1 Alpha Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
56975|NCT01243320|Primary|Change to Interleukin-8 Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||ng/mL||95% Confidence Interval|Mean
56976|NCT01243320|Primary|Sputum Reactive Oxygen Species Change|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||uM||95% Confidence Interval|Mean
56977|NCT01243320|Primary|Change in Eosinophil Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
56978|NCT01243320|Primary|Change in Basophils Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
56979|NCT01243320|Primary|Change In Monocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
56980|NCT01243320|Primary|Change In Lymphocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
56981|NCT01243320|Primary|Change In Granulocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
56982|NCT01243320|Primary|Change In Platelet Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||k/uL||95% Confidence Interval|Mean
56983|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days|||gm/dL||95% Confidence Interval|Mean
56984|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||pg||95% Confidence Interval|Mean
56985|NCT01243320|Primary|Change In Mean Corpuscular Volume Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days|||fL||95% Confidence Interval|Mean
56986|NCT01243320|Primary|Change In Hematocrit Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||percent||95% Confidence Interval|Mean
56987|NCT01243320|Primary|Change In Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||gm/dL||95% Confidence Interval|Mean
56988|NCT01243320|Primary|Change In Red Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||m/uL||95% Confidence Interval|Mean
56989|NCT01243320|Primary|Change In White Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||k/uL||95% Confidence Interval|Mean
56990|NCT01243320|Primary|Change In Calcium Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
56991|NCT01243320|Primary|Change in Albumin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||g/dL||95% Confidence Interval|Mean
56992|NCT01243320|Primary|Change In Total Bilirubin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||mg/dL||95% Confidence Interval|Mean
56993|NCT01243320|Primary|Change In Total Protein Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||g/dL||95% Confidence Interval|Mean
56994|NCT01243320|Primary|Change In Alanine Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||u/L||95% Confidence Interval|Mean
56995|NCT01243320|Primary|Change In Aspartate Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||u/L||95% Confidence Interval|Mean
56996|NCT01243320|Primary|Change In Alkaline Phosphatase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days|||u/L||95% Confidence Interval|Mean
66863|NCT01139450|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region||Baseline, 4 weeks||||||
57007|NCT01243294|Secondary|Wear Time (Registered by Subject When Applying and Removing a Product)|Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"||Hours|Participants|Standard Deviation|Mean
57008|NCT01243294|Secondary|Comfort (Subjects Own Assessment)|"Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.~Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.~Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"||Percent of participants|||Number
57009|NCT01243294|Secondary|Handling at Appliance (Subjects Own Assessment)|"Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.~Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.~Unit of measure is: Percentage of participants answering 'very easy' and 'easy'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"||Percent of participants|||Number
57010|NCT01243294|Secondary|Security (Subjects Own Assessment)|"Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.~Unit of measure is: Percentage of participants answering 'very good'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"||Percent of participants|||Number
57011|NCT01243294|Secondary|Adverse Events|Safety is evaluated by adverse events occuring continues while the subjects are testing the devices|During the investigation ~ 24 days per subject|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"||Adverse events|||Number
57012|NCT01243294|Primary|Leakage (Percent of All Base Plates With Leakage)|Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|Intention to treat. As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device||Percent of Base plates|Participants||Number
57013|NCT01243242|Secondary|Clinical Global Impression Scale (CGI-I)Score|"The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (‘very much improved’) through to 7 (‘very much worse’).~During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."|6 weeks from visit 1 baseline to visit 6|"The ITT population included all randomized subjects who completed at least one post-randomization visit.~During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."||units on a scale||Standard Deviation|Mean
57014|NCT01243242|Secondary|Adult ADHD Quality of Life (AAQoL)- Measuring Change in Total Score of AAQoL From Visit 1 to Visit 6|The AAQoL scale provides a validated disease-specific measure of the impact of ADHD on quality of life.It is scored as an overall score (29 items) and four subscale scores: life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Individual items are scored on a five-point Likert-like scale from ‘Not at all/Never’ (1) to ‘Extremely/Very Often’ (5).|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit||units on a scale||Standard Deviation|Mean
57015|NCT01243242|Secondary|Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6)|The TOVA is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning. ADHD score is a comparison of the subject's response to the CPT test to those of an ADHD group, and is reported as a Z-score. An ADHD score of -1.80 and less fits the profile of the ADHD sample. A score of more than -1.80 (more positive) does not fit the ADHD profile. When comparing ADHD scores the higher the ADHD score the better the performance.|6 weeks( visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.||Z score||Standard Deviation|Mean
57016|NCT01243242|Primary|Conners’ Adult ADHD Rating Scales (CAARS™)|The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 (‘Not at all’, ‘never’) to 3 (‘Very much’, ‘very frequently’). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.||units on a scale||Standard Deviation|Mean
66864|NCT01139450|Primary|Incidence of Success Based on the Investigator’s Global Evaluation at the End of Treatment||4 weeks|||participants|||Number
57017|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)|"An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose."|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.||Participants|||Number
57018|NCT01243177|Secondary|Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.|12 consecutive months of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.||percentage of subjects||95% Confidence Interval|Number
57019|NCT01243177|Primary|Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.||Participants|||Number
57020|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.||Participants|||Number
57021|NCT01243177|Primary|Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment|The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy.||percentage of subjects||95% Confidence Interval|Number
57022|NCT01243177|Primary|Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.||percentage of subjects||95% Confidence Interval|Number
57023|NCT01243112|Primary|Onset of Action|Time from infusion of local anesthetic to loss of sensation to sharp.|Up to 5 minutes|||second||Standard Deviation|Mean
57024|NCT01243112|Primary|Length of Action|The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.|Up to 12 hours|A calculation was made to power the study appropriately to determine a difference of 5 minutes based on previous studies which did not include the use of epinephrine.||minutes||Standard Deviation|Mean
57025|NCT01242813|Secondary|Number of Participants With Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.||Number of participants|||Number
57026|NCT01242813|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL).|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||pg/mL||Standard Deviation|Mean
57027|NCT01242813|Secondary|Serum Concentration of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug.|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||microgram(s)/milliliter||Standard Deviation|Mean
57316|NCT01239212|Secondary|Number of Participants With Adverse Events|Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.|24 hours after dose||||||
57029|NCT01242813|Secondary|Time to Relapse After Last Dose of Canakinumab|Relapse was defined as a Physician’s Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 85 to Day 253 (End of treatment period to Follow-up period)|The analysis was performed on the FAS population.||Days||95% Confidence Interval|Median
57030|NCT01242813|Secondary|Percentage of Relapsed Participants|Relapse was defined as a Physician’s Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
57031|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Participant's Global Assessment Score|Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 253 (End of follow-up period)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Percentage of participants|||Number
57032|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Physician’s Global Assessment Score|Participants were assessed based by physician on Physician’s Global Assessment measured on a 5-point scale for TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 953 (End of study)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Percentage of participants|||Number
57033|NCT01242813|Secondary|Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain|TRAPS signs and symptoms were assessed in 4 key categories: skin disease (skin rash), eye manifestations, extremity pain (musculoskeletal), and abdominal pain. Participants were assessed for TRAPS associated signs and symptoms a 5-point Physician’s global assessment scale: None/absent (no); 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 113 (end of treatment period) up to Day 925 (End of study)|The analysis was performed on the FAS population.||Percentage of participants|||Number
57034|NCT01242813|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. Negative percent change in concentration of inflammatory markers indicated improvement.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.||Percent change||Full Range|Median
57035|NCT01242813|Secondary|Time to Participant's Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a participant's Global Assessment of TRAPS symptoms of scale 1 or less. The participant's Global Assessment was based on a 5-point scale: 0 = None/absent (no) ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.||Days||95% Confidence Interval|Median
57036|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8|Participants who had not achieved a complete response at Day 8 were given an additional dose of canakinumab. Complete response was defined as clinical remission (Physician’s Global Assessment of TRAPS activity absent or minimal) and serological remission (CRP and/or SAA < 10 mg/L). Almost complete response was defined as clinical remission and a partial serological remission (≥ 70% reduction of baseline CRP and/or SAA).|Day 15|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."||Percentage of participants||95% Confidence Interval|Number
57037|NCT01242813|Secondary|Time to Physician’s Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a Physician’s Global Assessment of TRAPS symptoms of scale 1 or less. The physician's Global Assessment was based on a 5-point scale: 0 = None/absent ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.||Days||95% Confidence Interval|Median
57038|NCT01242813|Secondary|Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L.|Day 8 and Day 15|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
57039|NCT01242813|Secondary|Percentage of Participants With Complete Clinical Remission at Day 8 and 15|Complete clinical remission was defined as Physician’s Global Assessment of TRAPS activity to be absent or minimal (1). TRAPS associated clinical signs and symptoms were assessed by the investigator at every visit on a 5-point scale: 0 = Absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 8 and Day 15|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
57040|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 8|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician’s Global Assessment of TRAPS activity absent or minimal and serological remission was defined as CRP and/or SAA < 10 mg/L. Almost complete response was defined as clinical remission and a partial serological remission (≥70% reduction of baseline CRP and/or SAA).|Day 8|The analysis was performed on the FAS population.||Percentage of participants||95% Confidence Interval|Number
57041|NCT01242813|Primary|Percentage of Participants With Complete or Almost Complete Response at Day 15|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician’s Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than [≥] 70% reduction of baseline CRP and/or SAA).|Day 15|The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy.||Percentage of participants||95% Confidence Interval|Number
61193|NCT01195090|Secondary|Percentages of Patients With Severe Hypoglycemia|Proportion of severe hypoglycemia after treatment|24 weeks|Proportion of severe ypoglycemia after treatment||percentage|||Number
57042|NCT01242748|Secondary|Serum Levels of Prostate-specific Antigen (PSA) During 3 Years’ Treatment With Degarelix or Goserelin|Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||ng/mL||Full Range|Median
57043|NCT01242748|Secondary|Serum Levels of Testosterone During 3 Years’ Treatment With Degarelix or Goserelin|Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||ng/mL||Full Range|Median
57044|NCT01242748|Secondary|Hazard Ratio of Mortality Rates During 3 Years’ Treatment Between Degarelix and Goserelin|The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of deaths||95% Confidence Interval|Number
57045|NCT01242748|Secondary|Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years’ Treatment Between Degarelix and Goserelin|Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no additional therapy||95% Confidence Interval|Number
57046|NCT01242748|Secondary|Hazard Ratio of Testosterone Escape Rates During 3 Years’ Treatment Between Degarelix and Goserelin|Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no testosterone escape||95% Confidence Interval|Number
57047|NCT01242748|Secondary|Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no PSA failure||95% Confidence Interval|Number
57048|NCT01242748|Secondary|Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no PFS failure||95% Confidence Interval|Number
57049|NCT01242748|Primary|Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years’ Treatment Between Degarelix and Goserelin|PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.||percentage of no PSA-PFS||95% Confidence Interval|Number
57050|NCT01242527|Primary|Fasting Serum Triglycerides|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups|12 weeks|The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented.||Percent change from baseline||95% Confidence Interval|Least Squares Mean
57051|NCT01242514|Secondary|Mean HAQ-DI Score|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Units on a scale||Standard Deviation|Mean
57052|NCT01242514|Secondary|Mean mTSS Score|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily|Weeks 0 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Units on a scale||Standard Deviation|Mean
57317|NCT01239212|Secondary|Change in Vital Sign Baseline|Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.|24 hours after loading dose||||||
57053|NCT01242514|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study (variable duration; maximum 109 weeks)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Percentage of patients|||Number
57054|NCT01242514|Secondary|Mean DAS28-CRP Score|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||Units on a scale||Standard Deviation|Mean
57055|NCT01242371|Secondary|Measurement of Gliadin and Casein Antibody Levels||16 weeks (baseline prior to placebo run in to week 14)||||||
57056|NCT01242371|Secondary|Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14|"Self report rating of difficulty moving bowels on a 4 point scale from no difficulty to severe difficulty"|14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)||||||
57057|NCT01242371|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.|14 weeks (week 0 to week 14)|Week 0 data is based on the number of participants in the probiotic supplement group (n=33) and the placebo group (n=32) who began the treatment phase. Week 14 data is based on the number of participants in the probiotics supplement group (n=31) and the placebo group (n=27) who completed the treatment phase.||units on a scale||Standard Deviation|Mean
57058|NCT01242176|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Standard Deviation|Mean
57059|NCT01242176|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol/L||Standard Deviation|Mean
57060|NCT01242176|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the coefficient of variation (CV (%))."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.||nmol*h/L||Standard Deviation|Mean
57061|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test FVC During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Forced Vital Capacity.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage change||Standard Deviation|Mean
57062|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test MVV During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage change||Standard Deviation|Mean
57063|NCT01242111|Secondary|Percent Change From Baseline in Urine Keratan Sulfate (uKS) Levels During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 168 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage change||Standard Deviation|Mean
57064|NCT01242111|Secondary|Change in Baseline in Endurance as Measured by the 3 Minute Stair Climb During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in the 3-minute Stair Climb Test (3MSCT). Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.||steps/min||Standard Deviation|Mean
67708|NCT01130844|Primary|Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS||ug/L||Standard Deviation|Mean
57065|NCT01242111|Secondary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.||meters||Standard Deviation|Mean
57066|NCT01242111|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).~The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 240 weeks|The primary outcome measure data is presented in more detail under the Adverse Events section.||participants|||Number
57067|NCT01242085|Primary|Alignment of Knee - Measured Mechanical Axis From CT Data|the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment|postoperatively - CT done within 1 week of surgery|all participants who completed the study||degrees||95% Confidence Interval|Mean
57068|NCT01242085|Secondary|Surgical Time|the difference between the average surgical time will be determined and compared with 95% CI|intraoperative surgical time|particpants who completed study||delta between means in minutes||95% Confidence Interval|Mean
57069|NCT01241916|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|12 months|||units on a scale||Full Range|Mean
57070|NCT01241916|Primary|Change in Arc of Flexion and Extension|Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.|baseline and 6 months|||Degrees||Full Range|Mean
57071|NCT01241903|Secondary|Biomarkers of Platelet Function and Myocardial Necrosis||up to 30 days||||||
57072|NCT01241903|Primary|Platelet - Leukocyte Aggregates|measured by flow cytometry|within first 24 hours|||% leukocytes with platelets attached||Standard Error|Mean
57073|NCT01241760|Secondary|Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)|The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.|End of trial, 12 weeks after the last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
57074|NCT01241760|Secondary|Percentage of Participants Who Relapsed During Follow-up Period|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug)|The analysis was performed on subjects with HCV RNA <25 IU/mL at the planned end of treatment, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.||percentage of participants|||Number
57075|NCT01241760|Secondary|Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs|The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.|Week 4, 12, 24, 32, 40|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants|||Number
57076|NCT01241760|Secondary|Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.|Baseline, Week 4 and Week 4+12.|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
57077|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)|The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).|End of trial, 72 weeks after the start of study medication|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
57078|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)|The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.|End of trial, 24 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
57189|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||scores on a scale||Standard Deviation|Mean
57079|NCT01241760|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)|The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).|End of trial, 12 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.||percentage of participants with response|||Number
57080|NCT01241591|Secondary|Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Week 12|FAS; OC||scores on a scale||Standard Error|Mean
57081|NCT01241591|Secondary|Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
57082|NCT01241591|Secondary|Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.|Week 12|FAS; OC||percentage of participants|||Number
57083|NCT01241591|Secondary|Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.|Baseline and Week 12|FAS; OC||percentage of participants|||Number
57084|NCT01241591|Secondary|Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment||Week 12|FAS; OC||percentage of participants|||Number
57085|NCT01241591|Secondary|Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.|Baseline (BL) and Week 12|FAS; OC||percentage of participants|||Number
57086|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Week 12|FAS; OC||scores on a scale||Standard Error|Mean
57087|NCT01241591|Secondary|Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 12|FAS; OC||Units on a scale||Standard Error|Mean
57088|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D VAS at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Week 12|FAS; OC||mm||Standard Error|Mean
57089|NCT01241591|Secondary|Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 12|FAS; OC||mm||Standard Error|Mean
57090|NCT01241591|Secondary|Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Week 12|FAS; OC||scores on a scale||Standard Error|Least Squares Mean
57208|NCT01240902|Secondary|Major Adverse Events (MAEs)|"MAEs Include:~MACCE~Acute Kidney Injury~Cardiac Tamponade~Prosthetic Valve Dysfunction~Cardiogenic Shock~Valve Endocarditis~Life-Threatening, Disabling or Major Bleeding~Major Vascular Complication~Cardiac Perforation~Device Migration/Valve Embolism"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
57091|NCT01241591|Secondary|Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
57092|NCT01241591|Secondary|Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12|The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from “very dissatisfied” to “very satisfied” with the study medication.|Week 12|FAS; OC||percentage of participants|||Number
57093|NCT01241591|Secondary|Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment|The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from “very dissatisfied” to “very satisfied” with the study medication.|Week 12|FAS; OC||percentage of participants|||Number
57094|NCT01241591|Secondary|Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
57095|NCT01241591|Secondary|Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline and Weeks 2, 4, and 8|FAS; OC||percentage of participants|||Number
57096|NCT01241591|Secondary|Mean Change From Baseline in SF-36 Domain Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Week 12|FAS; OC||score on a scale||Standard Error|Mean
57097|NCT01241591|Secondary|Mean Change From Baseline in SF-36 MCS and PCS Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Week 12|FAS; OC||score on a scale||Standard Error|Mean
57098|NCT01241591|Secondary|Mean SF-36 Domain Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
57099|NCT01241591|Secondary|Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC||score on a scale||Standard Error|Mean
57100|NCT01241591|Secondary|Median Time to DLQI Response|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. DLQI Response was defined as a 5-point reduction in the total DLQI score.|Weeks 4 and 12|Data were not analyzed as the endpoint of proportion of participants achieving a 5-point reduction from baseline in DLQI provided similar information.|||||
57101|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC||percentage of participants|||Number
57102|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC||percentage of participants|||Number
57343|NCT01238900|Secondary|Number of Endoscopic Treatments Per Patient|The average number of ERCPs performed per patient required for resolution of benign strictures.|At time of procedure|||endoscopic treatments||Full Range|Mean
57103|NCT01241591|Secondary|Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC||scores on a scale||Standard Error|Mean
57104|NCT01241591|Secondary|Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4 and 12|FAS; OC||score on a scale||Standard Error|Mean
57105|NCT01241591|Secondary|Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC||score on a scale||Standard Error|Mean
57106|NCT01241591|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4 and 12|FAS; OC||score on a scale||Standard Error|Mean
57107|NCT01241591|Secondary|Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
57108|NCT01241591|Secondary|Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
57109|NCT01241591|Secondary|Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline, Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
57110|NCT01241591|Secondary|Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment||Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
57111|NCT01241591|Secondary|Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC||weeks||95% Confidence Interval|Median
57112|NCT01241591|Secondary|Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
57113|NCT01241591|Secondary|Median Time to PASI50 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC||weeks||95% Confidence Interval|Median
57114|NCT01241591|Secondary|Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||percentage of participatns|||Number
57115|NCT01241591|Secondary|Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant(fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||percent change from baseline||Standard Error|Mean
57116|NCT01241591|Secondary|Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||percent psoriatic BSA||Standard Error|Mean
57117|NCT01241591|Secondary|Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||scores on a scale||Standard Error|Mean
57118|NCT01241591|Secondary|Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
57119|NCT01241591|Secondary|Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC||scores on a scale||Standard Error|Mean
57120|NCT01241591|Secondary|Mean PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||score on a scale||Standard Error|Mean
57121|NCT01241591|Secondary|Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.|Weeks 2, 4, and 8|FAS; OC||percentage of participants|||Number
57122|NCT01241591|Secondary|Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 2, 4, 8, and 12|FAS; OC||percentage of participants|||Number
57123|NCT01241591|Secondary|"Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response is defined as 0 (clear) or 1 (almost clear).|Weeks 2, 4, and 8|FAS; Observed Case (OC): no imputation||percentage of participants|||Number
57124|NCT01241591|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.|Week 12|FAS; NRI||percentage of participants|||Number
75236|NCT01054703|Secondary|Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures||1 wk, 2wk, 4wk, 6wk||||||
57125|NCT01241591|Primary|"Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 12|Full Analysis Set (FAS): all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550, etanercept, or placebo); Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.||percentage of participants|||Number
57126|NCT01241565|Secondary|Incidence of Serosal Tearing||Day 30|||participants||95% Confidence Interval|Number
57127|NCT01241565|Secondary|Duration of Chest Tube Following Surgery|Chest tube duration was calculated as removal date – placement date + 1|Approximately Day 5|||days||Standard Deviation|Mean
57128|NCT01241565|Secondary|Length of Hospital Stay||Approximately Day 6|||days||Standard Deviation|Mean
57129|NCT01241565|Secondary|Duration of Air Leak|Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.|Day 30|||days||Standard Deviation|Mean
57130|NCT01241565|Secondary|Incidence of Air Leaks|As recorded on the air leak log.|Day 30|||number of patients with air leaks|||Number
57131|NCT01241565|Primary|Incidence of Prolonged Air Leaks|Defined as > 5 days by the Society for Thoracic Surgery|Day 30|||participants|||Number
57132|NCT01241552|Secondary|Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|Up to 12 weeks|Participants with compromised immunity at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57133|NCT01241552|Secondary|Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with an epidemic strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57134|NCT01241552|Secondary|Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with the B1/NAP1/027 strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57135|NCT01241552|Secondary|Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2)body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|Up to 12 weeks|Participants with clinically severe CDI at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57136|NCT01241552|Secondary|Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with a history of CDI in the 6 months prior to enrollment who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57137|NCT01241552|Secondary|Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants ≥ 65 years of age at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57209|NCT01240902|Secondary|The Occurrence of Individual MACCE Components|"Individual MACCE Components Include:~All Cause Mortality~MI~All stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
57138|NCT01241552|Primary|Percentage of Participants With Infusion-specific AEs|Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.|Up to 24 hours|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
57139|NCT01241552|Primary|Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
57140|NCT01241552|Primary|Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor’s product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
57141|NCT01241552|Primary|Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor’s product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
57142|NCT01241552|Primary|Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
57143|NCT01241552|Primary|Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.||Percentage of participants|||Number
57144|NCT01241552|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; complied with Good Clinical Practice; and achieved clinical cure of the initial CDI episode.||Percentage of participants|||Number
57145|NCT01241552|Secondary|Percentage of Participants With Global Cure|Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57146|NCT01241552|Primary|Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.||Percentage of participants|||Number
57147|NCT01241539|Secondary|Additional Safety Parameters|By study design abnormalities could be due to dialysis or Dabigatran.|2 periods of 5 days each|TS||Participants|||Number
57148|NCT01241539|Secondary|Safety and Tolerability|Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.|2 periods of 5 days each|TS||Participants|||Number
57149|NCT01241539|Secondary|Coagulation Parameters|Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.|Day 3|TS||sec||Standard Deviation|Mean
57150|NCT01241539|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.|Day 3|PKS||h||Geometric Coefficient of Variation|Geometric Mean
57151|NCT01241539|Secondary|Maximum Plasma Concentrations of Dabigatran (Cmax)|Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.|Days 2 and 3|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
57152|NCT01241539|Secondary|Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)|Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.|Days 2 and 3|Pharmacokinetic set (PKS) includes all evaluable patients of the TS who received at least 1 dose of dabigatran etexilate, who provided at least 1 observation for at least 1 Pharmacokinetics (PK) endpoint, and who did not have important protocol violations relevant to the evaluation of PK||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
57153|NCT01241539|Primary|Plasma Concentration Extraction Ratio|Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).|4 hours|PKS||Percentage||Geometric Coefficient of Variation|Geometric Mean
57154|NCT01241539|Primary|Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis|Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.|4 hours|PKS||Percentage||Geometric Coefficient of Variation|Geometric Mean
57155|NCT01241539|Primary|Dialysis Clearance of Dabigatran|Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.|4 hours|Pharmacokinetic set (PKS) includes all evaluable patients of the treated set who received at least one dose of dabigatran etexilate and who provide at least one observation for at least one Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.||mL/min||Geometric Coefficient of Variation|Geometric Mean
57156|NCT01241513|Primary|Arterial Oxygen Saturation|Finger Pulse Oximetry to measure arterial oxygen saturation|Day 4 of treatment during acute altitude exposure|||percentage of oxygen saturation||Standard Deviation|Mean
57157|NCT01241292|Secondary|Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants|The detection of anti-elotuzumab anti-drug antibodies (ADAs) in human serum was performed using a validated bridging electrochemiluminescence immunoassay (ECLA) on the Meso Scale Discovery (MSD) platform. Sample collection was performed prior to administration of elotuzumab at Day 1 of each cycle.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
57158|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
57159|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
57210|NCT01240902|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~All Cause Mortality~Myocardial infarction (MI)~All Stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
57160|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes (absolute) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils (absolute): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
57161|NCT01241292|Secondary|Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmin was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate PK concentration profiles were summarized.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
57162|NCT01241292|Secondary|Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate Pharmacokinetic (PK) concentration profiles were summarized.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
57163|NCT01241292|Secondary|Number of Participants With Best Overall Response - Treated Participants|Complete response (CR) and Partial Response (PR) were based on the European Group for Blood and Bone Marrow Transplant (EBMT) Criteria. Very Good Partial response was derived from the International Myeloma Working Group (IMWG) criteria. Participants who had a reduction in M-protein or plasmacytoma but did not meet the EBMT criteria for PR were classified as minimal response (MR). Hematologic, radiologic and/or clinical assessments were done every cycle starting with cycle 2. Each cycle is 4 weeks in length (Day 1, Day 8, Day 15, Day 22). Cycle 2 began on study Day 29. CR=negative immunofixation 6 weeks, <5% plasma cells, no increase in size or number of lytic lesions, complete disappearance of extramedullary plasmacytoma. PR=≥50%reduction in M-protein for 6 weeks, ≥90% reduction of urinary light chain excretion or < 200 mg/24hours for 6 weeks, ≥50% reduction in size of extramedullary plasmacytoma present at baseline, no increase in size or number of lytic lesions.|Cycle 2 (Study Day 29) to last dose, up to 3 years|All participants who received at least one dose of study medication were summarized (Treated Participants).||participants|||Number
57164|NCT01241292|Primary|Number of Participants With Clinically Relevant Vital Sign Findings|Vital signs (body temperature, seated blood pressure, heart rate, and respiration rate) were recorded at screening on Days 1, 8, 15, and 22 of Cycles 1 and 2, on Days 1 and 15 of Cycle 3, and at the end of treatment. Blood pressure (Diastolic and Systolic) and heart rate were recorded after the participant sat quietly for at least 5 minutes. Clinical relevance of vital sign data was determined by the investigator.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized.||participants|||Number
57165|NCT01241292|Primary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014.|First dose (Day 1) to last dose plus 60 days, up to 3 years|All participants who received at least one dose of study medication were summarized (Treated Participants).||participants|||Number
57166|NCT01241279|Secondary|Visual Acuity|Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.|All visits through visit 4 (day 160-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.|||||
57167|NCT01241279|Primary|Amplitude of Accommodation|The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.|Visit 4 (postoperative day 120-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.|||||
57168|NCT01241240|Secondary|Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.|Weeks 1, 2, 4, 8 and 12|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
57190|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 4|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
57169|NCT01241240|Secondary|Change From Baseline in Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.|Baseline, Weeks 1, 2, 4 and 8|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
57170|NCT01241240|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.||mmHg||Standard Deviation|Mean
57171|NCT01240915|Secondary|Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16|Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding [RB]), if any.|Baseline and Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
57172|NCT01240915|Secondary|Change From Baseline in Biopsy Histology Scores at Week 8|A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
57173|NCT01240915|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
57174|NCT01240915|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment [PGA]), each graded from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
57175|NCT01240915|Secondary|Percentage of Participants in Clinical Response at Week 8|Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
57176|NCT01240915|Secondary|Percentage of Participants With Endoscopic Response at Week 8|Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
57177|NCT01240915|Secondary|Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
57178|NCT01240915|Secondary|Percentage of Participants in Clinical Remission at Week 8|Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
61194|NCT01195090|Primary|The Percentages of Patient Achieving an A1C <7%|The percentages of patient achieving an A1C <7% at endpoint|24 weeks|The percentages of patient achieving an A1C <7% at endpoint||percentage|||Number
57179|NCT01240915|Secondary|Percentage of Participants in Endoscopic Remission at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
57180|NCT01240915|Secondary|Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).|Week 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.||percentage of participants|||Number
57181|NCT01240915|Secondary|Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16|CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||fold change||Geometric Coefficient of Variation|Geometric Mean
57182|NCT01240915|Secondary|Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16|Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||fold change||Geometric Coefficient of Variation|Geometric Mean
57183|NCT01240915|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP <90 millimeters of mercury (mm Hg) and >=30 mm Hg increase/decrease from baseline, DBP <50 mm Hg and >=20 mm Hg increase/decrease from baseline, pulse rate <40 or >120 beats per minute (bpm),|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||participants|||Number
57184|NCT01240915|Secondary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.|Baseline up to Week 24|The safety analysis population consisted of all participants who received at least 1 dose of study medication; n=the number of participants analyzed at that time point in the respective arms.||participants|||Number
57185|NCT01240915|Secondary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 12, Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.||scores on a scale||Standard Deviation|Mean
57186|NCT01240915|Primary|Number of Treatment-Emergent AEs by Severity|The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||adverse events|||Number
57187|NCT01240915|Primary|Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)||Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||participants|||Number
57188|NCT01240915|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.||participants|||Number
57268|NCT01240200|Primary|Treatment Satisfaction Based on Patient Survey|The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.|at 0 weeks||||||
57191|NCT01240915|Primary|Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint. Baseline observation carried forward (BOCF) was used for treatment failures.||scores on a scale||Standard Deviation|Mean
57192|NCT01240902|Secondary|Prosthetic Valve Dysfunction (PVD)|"PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:~Peak velocity >4 m/s~Mean gradient >35 mmHg~EOA < 0.8 cm2~TVIV1 / TVIV2 < 0.25"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||percentage of participants|||Number
57193|NCT01240902|Secondary|Procedural Success|"Medtronic CoreValve® System subjects only.~Defined as device success and absence of in-hospital MACCE."|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.||percentage of participants|||Number
57194|NCT01240902|Secondary|Device Success|"Medtronic CoreValve® System subjects only.~Defined as:~Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,~Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),~Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)~Only one valve implanted in the proper anatomical location"|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.||percentage of participants|||Number
57195|NCT01240902|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge|Participant Population= Consisted of all subjects with an attempted implant procedure.||days||Standard Deviation|Mean
57196|NCT01240902|Secondary|Index Procedure Related MAEs||Procedure|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants|||Number
57197|NCT01240902|Secondary|Strokes and Transient Ischemic Attacks (TIAs)|Strokes (of any severity) and TIAs|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
57198|NCT01240902|Secondary|Cardiovascular Deaths and Valve Related Deaths||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
57199|NCT01240902|Secondary|Aortic Valve Hospitalizations||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure||percentage of participants, Kaplan-Meier|||Number
57200|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||percentage of participants|||Number
57201|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:~- Transvalvular Mean Gradient"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||mmHg||Standard Deviation|Mean
57202|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:~- Effective Orifice Area (EOA)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.||cm^2||Standard Deviation|Mean
57203|NCT01240902|Secondary|Quality of Life (QoL) Change|"QoL summary score change from baseline using the following measures:~Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||units on a scale||Standard Deviation|Mean
57204|NCT01240902|Secondary|Ratio of Days Alive Out of Hospital Versus Total Days Alive||1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||ratio of days alive and out of hospital||Standard Deviation|Mean
57205|NCT01240902|Secondary|Change in Distance Walked During 6-Minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|30 day, 1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||meters||Standard Deviation|Mean
57206|NCT01240902|Secondary|Change in NYHA Class|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.~New York Heart Association (NYHA) Classification:~Class I: Subjects with cardiac disease but without resulting limitations of physical activity.~Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||average classification level change||Standard Deviation|Mean
57207|NCT01240902|Secondary|Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
57284|NCT01239745|Secondary|Time to Discontinuation||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
57211|NCT01240902|Primary|Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality|All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)|1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.||percentage of participants, Kaplan-Meier|||Number
57212|NCT01240811|Secondary|Vaginal and Endometrial Flora|Changes in vaginal and endometrial flora as assessed by qualitative and quantitative culture|2 Months||||||
57213|NCT01240811|Primary|%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium|Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety|2 months|All 40 participants who completed the study were included in the analysis. There were no lost-to-follow up participants. One participant withdrew and one participant was excluded post-enrollment. Both of these participants were replaced to fill our goal enrollment of 40 participants in the study.||% of T-cells expressing CCR5||Standard Deviation|Mean
57214|NCT01240785|Secondary|Child Outcome at 2 Years Per Arm|neuropsychological and motor skills testing|2 years after birth||||||
57215|NCT01240785|Secondary|Neonate Transfer to Intensive Care Unit Per Arm||0-5 days after delivery|||participants|||Number
57216|NCT01240785|Secondary|Apgar Score at 5 Min After Delivery Per Arm|Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome|5 minutes after delivery|||units on a scale||Standard Deviation|Mean
57217|NCT01240785|Secondary|Neonatal Hyperbilirubinemia Per Arm||0-3 days after delivery|||participants|||Number
57218|NCT01240785|Secondary|Neonatal Hypoglycemia Per Arm||0-24 h after delivery|||participants|||Number
57219|NCT01240785|Secondary|Shoulder Dystocia Per Arm||delivery|||participants|||Number
57220|NCT01240785|Secondary|Induction of Delivery Per Arm||delivery|||participants|||Number
57221|NCT01240785|Secondary|Gestational Weeks at Delivery Per Arm||delivery|||weeks||Standard Deviation|Mean
57222|NCT01240785|Secondary|Mode of Delivery Per Arm||delivery|||no of cesarean section|||Number
57223|NCT01240785|Secondary|Pre-eclampsia Per Arm||up to on the average 40 weeks of gestation|||participants|||Number
57224|NCT01240785|Secondary|Maternal Weight Gain Per Arm||up to on the average 40 weeks of gestation|||kg||Standard Deviation|Mean
57225|NCT01240785|Secondary|Pregnancy Induced Hypertension Per Arm|Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg|up to on the average 40 weeks of gestation|||participants|||Number
57226|NCT01240785|Primary|Birth Weight Per Arm|birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies|delivery|||g||Standard Deviation|Mean
57227|NCT01240746|Other Pre-specified|Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 3 years to <9 years with available data for the relevant endpoint.||Participants|||Number
57228|NCT01240746|Other Pre-specified|Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.|"Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.~Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: >103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable.~Solicited Injection site reactions (Age 24 Months to < 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 6 months to <36 months with available data for the relevant endpoint.||Participants|||Number
57229|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post-vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 Years with valid serology results for the particular antigen.||Titers||95% Confidence Interval|Geometric Mean
57230|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
57285|NCT01239745|Secondary|Number of Participants With Reasons for Discontinuation From Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
61195|NCT01195090|Primary|Baseline A1C|baseline A1C|Baseline|baseline Laboratory measurements||percentage of Hb||Standard Deviation|Mean
57231|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
57232|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 years with valid serology results for the particular antigen.||Participants|||Number
57233|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.||Participants|||Number
57234|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens.||Participants|||Number
57235|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.||Titers||95% Confidence Interval|Geometric Mean
57236|NCT01240746|Other Pre-specified|Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to vaccine antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
57237|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)"|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.||Participants|||Number
57238|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.||Titers||95% Confidence Interval|Geometric Mean
57239|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.||Titers||95% Confidence Interval|Geometric Mean
57286|NCT01239745|Secondary|Percentage of Participants Who Discontinued the Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
57240|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination"|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
57241|NCT01240746|Primary|Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers (GMT) to influenza vaccine A antigens were determined in randomized and vaccinated participants, per-protocol population. The GMT data for antigen A/Victoria/210/2009 and A/California/07/2009 were pooled for participants vaccinated with either 2010-2011 TIV or the investigational TIV. Data presented in column for Group 1.||Titers||95% Confidence Interval|Geometric Mean
57242|NCT01240590|Primary|Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)|Here is the number of participants with serious and non-serious adverse events. For a detailed list of adverse events, see the adverse event module.|34 months and 10 days|||participants|||Number
57243|NCT01240590|Primary|Progression Free Survival (Phase II)|Progression free survival (PFS) is defined as the duration of time from start of study treatment to time of progression. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as: Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 weeks|The outcome was not met because the patients died and were not scanned before their death.|||||
57244|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks|||mg/m^2|||Number
57245|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks|||mg/m^2|||Number
57246|NCT01240551|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|52.5 months|||participants|||Number
57247|NCT01240551|Primary|Number of Participants With Present or Not Present Bone Metastasis|Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.|Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.|Patient with known prostate cancer. One group with known metastatic bone disease, based on prior clinical imaging scan (Tc-99m bone scan or NaF-18 bone scan or CT, and a second group with clinical risk factors for obtaining bony metastatic disease (i.e. pelvic soft tissue mets, high PSA (prostate specific antigen) blood levels).||participants|||Number
57248|NCT01240382|Primary|Mean Change in Rose Bengal Staining Score From Baseline|"Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.~The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.||points||Standard Deviation|Mean
57249|NCT01240382|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.~The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.||points||Standard Deviation|Mean
57250|NCT01240356|Primary|Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination|The neurological examinations comprised assessments of mental status and orientation, cranial nerve examination, muscle strength and tone, deep tendon reflexes, sensory testing, coordination, and gait.|2-3 hours after treatment|||participants|||Number
57287|NCT01239745|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||participants|||Number
57251|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)|A modified Rankin Scale (mRS) score of 0 or 1 indicates an excellent outcome. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS scale ranks patients from 0 to 6 (0 is the best score, 6 is the worst score).|at 3-months from enrollment|ITT with modified Ranking scores (mSR) at 90 days. % displayed is % with excellent outcome (mRS of 0-1).||percentage of patients||95% Confidence Interval|Number
57252|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale|The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. Each item on the NIHSS scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|within 90 days of enrollment|||percentage of patients||95% Confidence Interval|Number
57253|NCT01240356|Secondary|Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems|Ischemic stroke patients: 2-hour rates of arterial complete and partial recanalization as measured using standard Transcranial Doppler Ultrasound systems.|2-3 hours after treatment|ITT - Percent of patients who had complete recanalization after treatment.||percentage of patients||95% Confidence Interval|Number
57254|NCT01240356|Secondary|Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD|Phase I - A group of healthy volunteers will be assessed to determine the feasibility and activity of hands-free (HF) transcranial Doppler (TCD). Adverse events include subject complaints regarding discomfort of the device and dermatological adverse events as evidenced by a detailed physical examination of skin integrity post-insonation.|2-3 hours after treatment|ITT||participants|||Number
57255|NCT01240356|Primary|Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage|Phase II: Determine if the Hands-Free TCD will not result in higher than 10% rate of symptomatic intracerebral hemorrhage (ICH) within 24 hours (defined as clinical worsening > 4 NIH Stroke Scale (NIHSS) points and presence of hemorrhage on CT scan that in the opinion of the treating physician is causatively related to ICH on CT) in 0-3 hours acute stroke patients treated with intravenous tissue-type plasminogen activator (IV-t-PA).|within 24 hours|Intention to Treat (ITT)||percentage of patients||95% Confidence Interval|Number
57256|NCT01240356|Primary|Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain|Phase I : Imaging of the brain via MRI scans was performed to determine if the Hands-Free transcranial Doppler (TCD) system results in any BBB-disruption or deterioration in permeability.|2-3 hours after treatment|||participants|||Number
57257|NCT01240330|Secondary|Subject Comfort|Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.|10 min therapy|||Units on a Scale||Standard Deviation|Mean
57258|NCT01240330|Secondary|PFV Percent Augmentation|Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.|3 measurements/10 minute therapy|||percentages||Standard Deviation|Mean
57259|NCT01240330|Primary|Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline|The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.|3 measurements/10 min. therapy|||cm/s||95% Confidence Interval|Mean
57260|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 24 weeks||||||
57261|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 24 weeks||||||
57262|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 12 weeks||||||
57263|NCT01240200|Secondary|Blood Glucose Control|Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia|at 12 weeks||||||
57264|NCT01240200|Secondary|Blood Glucose Control|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 0 weeks||||||
57265|NCT01240200|Secondary|Blood Glucose Control|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia"|at 0 weeks||||||
57266|NCT01240200|Primary|Treatment Satisfaction|The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.|at 24 weeks||||||
57267|NCT01240200|Primary|Treatment Satisfaction|The treatment satisfaction scores were obtained from the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale (0-6). DTSQs scores range from, e.g, 6 = very satisfied to 0 = very dissatisfied. The total satisfaction score when using the DTSQs ranges from 0 to 36; and the total score is obtained from summed scores from questions 1, 4, 5, 6, 7, and 8. This outcome measure is assessed after the first intervention (at 12 weeks into the study).|12 weeks|||units on a scale||Standard Deviation|Mean
75599|NCT01050660|Secondary|Incidence of Necrotizing Enterocolitis (NEC)||At discharge from Newborn ICU|||participants who developed NEC|||Number
57269|NCT01240135|Secondary|Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score|The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.||units on a scale||Standard Deviation|Mean
57270|NCT01240135|Primary|Lens Fit|As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.||percentage of acceptable fit|||Number
57271|NCT01240122|Secondary|Overall Ocular Comfort|All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.|Day 4|All subjects who completed the study were included in the analysis per protocol.||score on a scale||Standard Deviation|Mean
57272|NCT01240122|Secondary|Subjective Solution Preference|Subject asked which solution they prefer based on comfort level.|Day 4||||||
57273|NCT01240122|Primary|Corneal Staining by Wear Time|All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.|1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4|Corneal Staining Severity at Scheduled Visits (Safety Population)||participants|||Number
57274|NCT01239992|Other Pre-specified|LDL-cholesterol|Percent change of LDL-cholesterol at 12 weeks compared to baseline|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
57275|NCT01239992|Secondary|Fasting Triglycerides|Percent change of fasting triglycerides at 12 weeks compared to baseline|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
57276|NCT01239992|Secondary|HDL Cholesterol|Percent change of HDL-cholesterol at 12 weeks compared to baseline.|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
57277|NCT01239992|Primary|Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test|Percent change of incremental AUC at 12 weeks compared to baseline.|baseline and 12 weeks after treatment|||percentage change||Standard Deviation|Mean
57278|NCT01239797|Secondary|Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores|"Outcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 (No pain, No interference) to 10 (Pain as bad as you can imagine, Highest imaginable interference) numeric rating scale."|Baseline to Study Completion (up to 7 years)||10/2019||||
57279|NCT01239797|Secondary|Median Overall Survival (OS)|Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|Randomization to 427 deaths (approximately 7 years)||10/2019||||
57280|NCT01239797|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.|Randomization to end of treatment (approximately 2 years)|All participants randomized to any treatment group||percentage of participants||95% Confidence Interval|Number
57281|NCT01239797|Primary|Median Progression Free Survival (PFS)|Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.|Randomization until 326 events (approximately 2 years)|All participants randomized to any treatment group||months||95% Confidence Interval|Median
57282|NCT01239745|Secondary|Overall Survival|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to Month 36)|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
57283|NCT01239745|Secondary|Recurrence-free Survival|Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.|Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
57288|NCT01239745|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||participants|||Number
57289|NCT01239745|Primary|Number of Participants With Adverse Events (AEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||participants|||Number
57290|NCT01239732|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).|3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|Previous studies linking CA-125 levels with bevacizumab exposure as a potential secondary outcome measure for PFS did not produce any reliable information. Therefore, it was decided that data for this outcome measure should not be analyzed, as agreed with the study steering committee.|||||
57291|NCT01239732|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.|First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years|ITT population||months||95% Confidence Interval|Median
57292|NCT01239732|Secondary|Duration of Objective Response (DOR)|DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population||months||95% Confidence Interval|Median
57293|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria|Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.|RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
57294|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria|CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).|3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
57312|NCT01239316|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patient with sustained objective response||months|||Number
57313|NCT01239316|Primary|Pharmacokinetics (Plasma) of GDC-0449|plasma GDC-0449 concentration of day 21 in first course|up to 12 month|Patients who have day 21 plasma GDC-0449 concentration data available||uM||Full Range|Median
58793|NCT01222104|Secondary|Rate of Minor Vascular Complications by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.|30 days|||% of procedures with minor vasc comp.|Participants||Number
57295|NCT01239732|Secondary|Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
57296|NCT01239732|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|Intent to treat population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
57297|NCT01239732|Primary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)|Safety population||percentage of participants|||Number
57298|NCT01239680|Primary|Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).|Biological response as characterized by selected cytokines, specifically tumor necrosis factor alpha (TNFα), interleukin one (IL-1β), and interleukin six (IL-6). These are measured using ELISA. Baseline values are expected to be either unobtainable, or in any case less than 50 picograms/ml. If there is a significant inflammatory response, values at 24 hours should be more than 100 picograms/ml for TNFα, IL-1β, and IL-6. Our hypothesis is that there will be a difference between study and control group patients of at least 50 picograms/ml in the levels of these cytokines at 24 hours. Cytokine response is quite variable, and the percentage of outliers (with no cytokine response) in either group may be as high as 50%. .|Change from Baseline in Cytokine Levels at 24 hours|The number of participants who had an intervention and completed the study with all 3 required blood draws.|||||
57299|NCT01239511|Secondary|Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.||6 weeks||||||
57300|NCT01239511|Secondary|Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits||6 weeks||||||
57301|NCT01239511|Secondary|Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits||6 weeks||||||
57302|NCT01239511|Secondary|Change in Consumption of Short-acting Nitrates From Baseline to All Visits||6 weeks||||||
57303|NCT01239511|Secondary|Changes in Angina Frequency in Subject's Diary From Baseline to All Visits||6 weeks||||||
57304|NCT01239511|Secondary|Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit||6 weeks||||||
57305|NCT01239511|Secondary|Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit||6 weeks||||||
57306|NCT01239511|Secondary|Change in Time to Onset of Angina From Baseline to the Final Visit||6 weeks||||||
57307|NCT01239511|Primary|Change in Total Exercise Time (Seconds)|the time difference of total exercise time from V2 to V5 compare to placebo|6 weeks after the first exercise tolerance testing is conducted|ITT (intend-to-treat) population will be used for analysis||second||Standard Deviation|Least Squares Mean
57308|NCT01239355|Secondary|Overall Survival|Survival will be estimated by the product-limit (Kaplan-Meier) estimator.|Until death, up to 26 months|||Months||95% Confidence Interval|Median
57309|NCT01239355|Secondary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months|||participants|||Number
57310|NCT01239355|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression or death, up to 26 months|||Months||95% Confidence Interval|Median
57311|NCT01239316|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data||penetration rate||Full Range|Median
57314|NCT01239316|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years|||months||95% Confidence Interval|Median
57318|NCT01239212|Primary|Pharmacokinetic Profile|3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.|5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)|all participants had adequate levels drawn for analysis||ml/min/kg||Full Range|Median
57319|NCT01239121|Secondary|Medication-related Symptoms|Patient's self-report of medication-related symptoms by telephone questionnaire|Up to 1 month after hospital discharge|"For this outcome 66 and 87 participants unable to be reached by telephone in first and second arms, respectively.~Outcome not ascertained in the third arm because those participants were not hospitalized."||participants|||Number
57320|NCT01239121|Secondary|Adverse Drug Events|Actual harm to patient from hospital medication discrepancies by record review|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.||participants|||Number
57321|NCT01239121|Primary|Transition Drug Risk|Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.||units: risk-weighted discrepancies||Standard Deviation|Mean
57322|NCT01239056|Secondary|Adverse Events||1 year|||participants|||Number
57323|NCT01239056|Primary|Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen|"Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst .~Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst."|baseline|||participants|||Number
57324|NCT01239056|Secondary|Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).||6 to 12 weeks after baseline|||participants|||Number
57325|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Participants|||Number
57326|NCT01239043|Other Pre-specified|Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine and serology samples with valid test results (Per-Protocol Population).||Participants|||Number
57327|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
57328|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Participants|||Number
57329|NCT01239043|Other Pre-specified|Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Participants|||Number
57330|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
57331|NCT01239043|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.~Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - > 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF."|Day 0 to Day 7 post-vaccination|Solicited reactions were assessed in all subjects who received at a dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
61772|NCT01191190|Secondary|IwCLL-WG Defined Nodular Partial Response (PR)|Responses were assessed two months after completion of therapy|2 months|||participants|||Number
57332|NCT01238991|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the MMSE scores were not summarized.|||||
57333|NCT01238991|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the NTB scores were not summarized.|||||
57334|NCT01238991|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the DAD scores were not summarized.|||||
57335|NCT01238991|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the ADAS-Cog scores were not summarized.|||||
57336|NCT01238991|Other Pre-specified|Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the IgM data were not summarized.|||||
57337|NCT01238991|Other Pre-specified|Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection.||Units/mL||95% Confidence Interval|Geometric Mean
57338|NCT01238991|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.|Baseline of the preceding studies through 24 months of this study|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.||Participants|||Number
57339|NCT01238991|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.|||||
57340|NCT01238991|Primary|Number of Treatment Emergent Adverse Events (AEs) by Severity|Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.||Events|||Number
57341|NCT01238900|Secondary|Frequency and Severity of Adverse Events (Including Stent Migration)|Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria|up to 12 months|Stent migration was seen in 9/23 patients (5 downstream, 4 upstream). It was without clinical complications except in one case. Post-procedure pain experienced by 1 patient was effectively treated by downgrading the stent size to a smaller diameter.||participants|||Number
57342|NCT01238900|Secondary|Ease of Stent Removal|The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).|at time of procedure|||participants|||Number
57344|NCT01238900|Primary|Long-term Success Rate in Resolution of Biliary Strictures|Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.|at least 12 months after stent removal|Per-protocol analysis, the 18 participants available for long term success follow-up consisted of: 11 with CP, 3 with OLT, and 4 others. Intention to treat analysis of long-term success consisted of 22 overall patients, 12 CP patients, 3 OLT patients, and 7 other patients. This analysis included all patients lost to follow-up as long-term failures.||participants|||Number
57345|NCT01238900|Primary|Short Term Success Rate in the Resolution of Biliary Strictures|Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.|6 months|Of the 23 participants that entered the study, 22 saw short-term success. The population consisted of 14 Chronic pancreatitis patients, 4 postorthotopic liver transplant patients, and 5 others.||participants|||Number
57346|NCT01238861|Secondary|Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52|Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||parts per billion||Standard Deviation|Mean
57347|NCT01238861|Secondary|Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52|Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||percent nocturnal awakening-free nights||Standard Deviation|Mean
57348|NCT01238861|Secondary|Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
57349|NCT01238861|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
57350|NCT01238861|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline >=0.5), no change (defined as change from baseline >= -0.5 to less than [<] 0.5), and worse (defined as change from baseline < -0.5). Data was summarized by each treatment group.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."||units on a scale||Standard Deviation|Mean
57351|NCT01238861|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) at Week 52|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters per minute||Standard Deviation|Mean
57352|NCT01238861|Secondary|Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52|Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Deviation|Mean
57353|NCT01238861|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||liters||Standard Deviation|Mean
57354|NCT01238861|Secondary|Change From Baseline in Rescue Medication Use at Week 51-52|Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."||rescue medication per 2 weeks||Standard Deviation|Mean
57355|NCT01238861|Secondary|Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52|Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
57356|NCT01238861|Secondary|Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52|Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
57357|NCT01238861|Secondary|Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
57358|NCT01238861|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants|Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer >=50 at any point in the study. It was observed at baseline and any visit during the study.|Baseline up to Week 92|The mITT population included all randomized participants who received any dose of investigational product.||percentage of participants|||Number
57359|NCT01238861|Secondary|Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.||microgram per milliliter||Standard Deviation|Mean
57360|NCT01238861|Secondary|Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.||microgram per milliliter||Standard Deviation|Mean
57361|NCT01238861|Secondary|Dose Response in EOS+ Participants||Baseline up to Week 66|Due to change in planned analysis after unblinding of study data, dose response was not performed.|||||
57421|NCT01237353|Primary|Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)|Gastric pH levels monitored with a Heidelberg pH capsule (HC) which sends real-time signals to a computer system that visually plots intestinal pH on a minute-by-minute basis. When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours.|30 minutes|||units on a scale||Standard Deviation|Mean
57362|NCT01238861|Primary|Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants|The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.|Week 1 up to Week 52|The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.||AER events/person-year|||Number
57363|NCT01238848|Primary|Hospitalization Days|hospitalization days|Participants will be followed for the duration of hospitalization, an expected average of 4 days|||days||Standard Deviation|Median
57364|NCT01238848|Secondary|Length of Oxygen Use|Length of oxygen use (days)|Participants will be followed for the duration of hospitalization, an expected average of 4 days|||days||Standard Deviation|Median
57365|NCT01238822|Primary|Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items|"Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54~O - No ADHD symptoms 54 - Highest ADHD symptoms"|end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.|Intent to treat with imputation for missing data.||Score||Standard Deviation|Mean
57366|NCT01238640|Secondary|Product Dissolution Time|Product Dissolution Time is the time from administration until the investigational products were completely dissolved.|During 10 hours post-dose|||Minutes||Standard Deviation|Mean
57367|NCT01238640|Primary|AUC(0-∞)|AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).|10 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
57368|NCT01238640|Primary|Area Under the Curve [AUC(0-t)]|Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).|During 10 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
57369|NCT01238640|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)|During 10 hours post-dose|||ng/mL||Standard Deviation|Mean
57370|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Baseline|||units on a scale||95% Confidence Interval|Mean
57371|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline|||units on a scale||95% Confidence Interval|Mean
57372|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline|||units on a scale||95% Confidence Interval|Mean
57373|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|Baseline|||units on a scale||95% Confidence Interval|Mean
57374|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|Baseline|||units on a scale||95% Confidence Interval|Mean
57375|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|Baseline|||units on a scale||95% Confidence Interval|Mean
57376|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45.|Baseline|||units on a scale||95% Confidence Interval|Mean
57377|NCT01238575|Secondary|Aberrant Behavior Checklist Hyperactivity Subscale|"The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech.~The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48."|Baseline|||units on a scale||95% Confidence Interval|Mean
57378|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
57379|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
57380|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
57381|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
57382|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
57383|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 – 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45.|8 weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
57384|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Week 8|||units on a scale||95% Confidence Interval|Least Squares Mean
57385|NCT01238575|Primary|Aberrant Behavior Checklist Hyperactivity Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.|Week 8|||units on a scale||95% Confidence Interval|Least Squares Mean
57386|NCT01238471|Secondary|Safety of Propranolol Therapy in Premature Infants|Close monitoring for possible side effects of propranolol in premature infants|4 weeks of propranolol therapy in premature infants||||||
57387|NCT01238471|Primary|Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy|"If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome.~Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina."|propranolol therapy for up 4 weeks|||cases|||Number
57388|NCT01238341|Secondary|Total Procedure Time||During procedure, up to 3 hours|||minutes|Participants|Full Range|Mean
57389|NCT01238341|Secondary|Successful Endoscopic Therapy||During procedure, up to 3 hours|||ERCPs|Participants||Number
57390|NCT01238341|Secondary|Successful Cannulation of the Duct of Intent|Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.|During procedure, up to 3 hours|||ERCPs|Participants||Number
57391|NCT01238341|Primary|Papilla or Duct-enterostomy Was Reached||During procedure, up to 3 hours|||ERCPs|Participants||Number
57392|NCT01238211|Secondary|Overall Survival|Overall survival (OS) is defined as time from registration to death. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years||||||
57393|NCT01238211|Secondary|Disease-free Survival|Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The median DFS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years||||||
57394|NCT01238211|Secondary|Cumulative Incidence of Death||Up to 10 years||||||
57395|NCT01238211|Secondary|Cumulative Incidence of Relapse||Up to 10 years||||||
57396|NCT01238211|Secondary|Complete Response Rate|"Percentage of participants who achieve a CR.~CR is defined in the above outcome measure."|Up to 10 years||||||
57397|NCT01238211|Secondary|Event-free Survival|"Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The median EFS with 95% CI was estimated using the Kaplan-Meier method,~Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts)."|Up to 10 years||||||
57398|NCT01238211|Primary|30 Day Survival Rate|Percentage of participants who were alive 30 days after starting induction treatment.|30 days|||percentage of participants||95% Confidence Interval|Number
57399|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57400|NCT01237613|Secondary|Return to Work and Previous Physical Activities||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57401|NCT01237613|Secondary|Subjective Evaluation of Treatment||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57402|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57403|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57404|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57405|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57406|NCT01237613|Secondary|Return to Work and Previous Physical Activities||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57407|NCT01237613|Secondary|Subjective Evaluation of Treatment||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57408|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57409|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57410|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57411|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57412|NCT01237613|Secondary|Return to Work and Previous Physical Activities||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57413|NCT01237613|Secondary|Subjective Evaluation of Treatment||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57414|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57415|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57416|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57417|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57418|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57419|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.|||||
57420|NCT01237353|Secondary|Duration of Gastric pH Status|When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours|2 hours after dose of betaine HCl|||minutes||Standard Deviation|Mean
61773|NCT01191190|Secondary|IwCLL-WG Defined Overall Response Rate (ORR)|Responses were assessed two months after completion of therapy|2 months|||participants|||Number
57422|NCT01237340|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection).|Day 1 up to 28 days after last dose of study treatment|Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment.||participants|||Number
57423|NCT01237340|Secondary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||nmol/L||Standard Deviation|Mean
57424|NCT01237340|Secondary|Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)|Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.|Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."||standard deviation score||Standard Deviation|Mean
57425|NCT01237340|Secondary|Insulin-like Growth Factor-I (IGF-1) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."||nanomole per liter (nmol/L)||Standard Deviation|Mean
57426|NCT01237340|Secondary|Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®|Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.|Baseline up to Week 26|MITT population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.||participants|||Number
57427|NCT01237340|Primary|Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®|Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.|Baseline up to Week 26|Modified Intent-to-Treat (MITT) population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.||participants|||Number
57428|NCT01237327|Secondary|Time to Treatment Failure (TTF)|TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event.|Every 12 weeks up to 6 years|ITT||months||95% Confidence Interval|Median
57429|NCT01237327|Secondary|Time to Tumor Progression (TTP)|TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions.|Every 12 weeks up to 6 years|ITT||months||95% Confidence Interval|Median
57430|NCT01237327|Secondary|Duration of Response (DR)|Duration of objective response (complete response [CR] or partial response [PR]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response.|Every 12 weeks up to 6 years|ITT.||months||95% Confidence Interval|Median
57431|NCT01237327|Secondary|Objective Response Rate (ORR)|Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group|Every 12 weeks up to 6 years|ITT||percentage of participants|||Number
57432|NCT01237327|Primary|Overall Survival|Overall survival in months measured from date of starting treatment in core study to date of death for any reason.|Every 12 weeks up to 6 years|Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study.||months||95% Confidence Interval|Median
57433|NCT01237301|Secondary|The Secondary Objective is to Determine the Incremental Benefit of CGM for Clinical Decision-making.|"Outcome will be measured by:~i. HbA1c ii. Glucose exposure (area under the diurnal median curve) iii. Glucose variability (inter-quartile range) iv. Glucose stability (hourly change in the median curve) v. Incidence of hypoglycemia (degree, duration, frequency)"|16 weeks||||||
57434|NCT01237301|Primary|Percentage Change in Hemoglobin A1c||2 week baseline to 18 week final|Per Protocol||percentage of HbA1c||Standard Deviation|Mean
57435|NCT01237223|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.|8 weeks|Safety set: All patients who received at least one dose of double-blind study medication.||Participants|||Number
57436|NCT01237223|Secondary|Percentage of Participants Achieving a Successful Response Rate|The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication||percentage of participants|||Number
57437|NCT01237223|Secondary|Percentage of Participants Achieving Blood Pressure Control at Endpoint|Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication||percentage of participants|||Number
58794|NCT01222104|Secondary|Rate of Major Vascular Complications (MVCs) by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).|30 days|||% of procedures with MVCs|Participants||Number
57438|NCT01237223|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.||mm Hg||Standard Error|Least Squares Mean
57439|NCT01237223|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.||mm Hg||Standard Error|Least Squares Mean
57440|NCT01237197|Primary|Percent Change From Baseline in Body Mass Index at 3-months|As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.|Baseline and 3-months|||percentage of change in BMI||Standard Deviation|Mean
57441|NCT01237080|Primary|Time to Intubate||From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.|The sample size was calculated to 40 in each group (50 patients were included in each group): minimum relevant difference in intubation time of 20 s and a standard deviation of 28 s. A significance level of 0.05 and an acceptable risk of Type 2 error of 0.1 were used.||sec||95% Confidence Interval|Mean
57442|NCT01237080|Secondary|Postoperative Throat Pain.||one hour postoperative||||||
57443|NCT01237080|Secondary|Postoperative Hoarseness.||one hour postoperative.||||||
57444|NCT01237080|Secondary|Intubation of the Esophagus.||detected immediately||||||
57445|NCT01237080|Secondary|Subjectively Intubation Difficulty||measured immediately on a visual analogue scale.||||||
57446|NCT01237080|Secondary|Mucosal Lesion||inspection during intubation and one hour postop.||||||
57447|NCT01237080|Secondary|Lowest Saturation During Intubation.||measured on the monitor||||||
57448|NCT01237080|Primary|Number of Patients Intubated in the First Attempt|The intubation attempt was considered a failure if the GS or the FT was removed from the patient’s mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).|please see description|||participants|||Number
57449|NCT01237054|Primary|Number of Participants With Positive DCE-MRI Imaging Results|DCE-MRI, an FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA). The criteria was presence of early and diffuse hyper-enhancement compared to the surrounding bone marrow. The pattern of marrow involvement on MRI was characterized as: (1) normal when there was no evidence of abnormal signal intensity; (2) focal, which consisted of localized areas of abnormal marrow; the lesions are darker than yellow marrow and slightly darker than or isointense to red marrow on T1-weights images; (3) diffuse, in which normal bone marrow signal intensity is completely absent, the intervertebral disks appear brighter than or isointense to the diseased marrow; and finally (4) heterogeneous that consists of innumerable small foci of disease on a background of intact marrow, with small dark lesions on T1-weighted images, which become bright on T2-weighted image.|60 days|Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.||participants|||Number
57450|NCT01237054|Primary|Number of Participants With Positive and Negative 18F-FDG PET CT and F18-NaF PET CT Imaging Results in Individuals With MGUS, SMM, and MM.|18F-FDG PET CT and F18-NaF PET CT imaging results were compared in participants with MGUS, SMM, and MM. Lesions were considered positive if focal uptake corresponded to lesions identified on CT for NaF and negative if no uptake seen in lesions. Criteria to define FDG positivity included parameters published by Zamagni et al with focal abnormal uptake more intense than background.|60 days|||participants|||Number
57451|NCT01236573|Primary|Response (Complete Response (CR) + Partial Response (PR)) to Therapy|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline um LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions.|4 years|||participants|||Number
57452|NCT01236573|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|49 months and 20 days|||participants|||Number
57453|NCT01236573|Primary|Maximum Tolerated Dose (MTD)|The MTD was determined by evaluating dose limiting toxicities (DLT) of participants that received increasing doses of intravenous infusion of IL-12 gene transduced tumor infiltrating lymphocytes (TIL) (i.e., 1x10^6, 3x10^6, 3x10^7, 1x10^7, 3x10^7, 1x10^8, 3x10^8, 1x10^9, and 3x10^9) in cohorts 1-10. Maximum tolerated cell dose is the highest dose at which </= 1 of 6 patients experienced a DLT (i.e. grade 2 or greater allergic reaction)).|4 years|||Cells|||Number
57454|NCT01236534|Secondary|Number of Participants With Diarrheic Events.|To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients.|21 days|per protocol||participants|||Number
57455|NCT01236534|Primary|Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.|Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.|21 days|per protocol||spontaneous bowel movements||Standard Deviation|Mean
57456|NCT01236391|Secondary|Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score|Mean change from baseline to Cycle 5 in the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) Global Health Status Score according to EORTC QLQ-C30 Scoring Manual (3rd Edition, 2001). For global health status, positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. A change in 5 to 10 points in either direction represents a small change; 10 to 20 points represents a moderate change and greater than 20 points represents a large change.|From Baseline to Cycle 5 (Week 20)|||scores on a scale||Standard Deviation|Mean
57457|NCT01236391|Secondary|PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|Area under the plasma concentration-time curve using data collected at 0, 1, 2, 4, 6-8, and 24 hours post dose (AUC0-24h)|Performed During the First Month of Receiving PCI-32765|PK samples were collected in a subset of participants (n=48) in this trial (n=111). PK parameters reported here reflects those that were PK evaluable from the 48 participants.||AUC0-24h (ng*h/mL)||Standard Deviation|Mean
57458|NCT01236391|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure|||participants|||Number
57459|NCT01236391|Primary|Percentage of Participants Achieving Response|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin’s lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a >/= 50% decrease in the sum of the product of diameters of the target lesions, and >/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.|The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population||percentage of participants with response||95% Confidence Interval|Number
57460|NCT01236378|Secondary|Number of Participants With Estimated Glomerular Filtration Rate (GFR) Less Than (<) 60 mL/Min/1.73 m^2|GFR, an index of kidney function, describes flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using the Simplified Modification of Diet in Renal Dysfunction (MDRD) GFR equation. Normal GFR is >90 mL/min/1.73 m^2; children and older people usually have lower GFR. Often, kidney transplant recipients do not have normal GFRs. Lower values indicate poor kidney function. GFR <15 mL/min/1.73 m^2 is consistent with kidney failure. For this posting, the number of subjects with a GFR <60 mL/min/1.73 m^2 is listed.|From baseline up to Day 4|All participants.||participants|||Number
57461|NCT01236378|Secondary|Number of Participants With Serum Creatinine Levels More Than (>) 1.3 Times the Upper Limit of Normal|Serum creatinine, an indicator of kidney function, formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue, is removed from blood by kidneys and excreted in urine. Increased creatinine in blood indicates decreased kidney function. Creatinine levels are age, gender and race dependent as they are related to an individual’s muscle mass. Renal transplant recipients may have elevated serum creatinine. For this study an abnormal serum creatinine level is defined as 1.3 times the upper limit of normal (ULN) for the laboratory where the determination was performed.|From baseline up to Day 4|All participants.||participants|||Number
57462|NCT01236378|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||liter per hour (L/h)||Standard Deviation|Mean
57463|NCT01236378|Primary|Degree of Fluctuation (DF)|DF, also known as peak to trough fluctuation (PTF) (calculated as [Cmax minus Ctrough] divided by Cave), is a unit-less ratio of the Cmax to Ctrough decrease expressed as a fraction of the average concentration during a dosing interval.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||ratio||Standard Deviation|Mean
57464|NCT01236378|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
57465|NCT01236378|Primary|Average Blood Concentration at Steady State (Cave,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||ng/mL||Standard Deviation|Mean
57466|NCT01236378|Primary|Observed Blood Trough Concentration at Steady State (Ctrough,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||ng/mL||Standard Deviation|Mean
57467|NCT01236378|Primary|Time to Reach Maximum Observed Blood Concentration at Steady State (Tmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population||hours||Full Range|Median
57468|NCT01236378|Primary|Maximum Observed Blood Concentration at Steady State (Cmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK parameter analysis population: All treated participants who had at least 1 of the PK parameters of primary interest.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
57469|NCT01236365|Primary|Hs-CRP Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.|Randomization and 6 months|||mg/dL||Inter-Quartile Range|Median
57470|NCT01236365|Secondary|Subclinical Atherosclerosis and Vascular Stiffness With the Use of Abdominal Aortic MRI.|T1DM patients will have an MRI scan of the abdominal aorta using an image acquisition protocol to measure subclinical atherosclerosis and arterial stiffness. Subjects will be rescanned at the conclusion of the 6 month trial. A group of healthy, non diabetic age-matched controls will be scanned as well.|6 months||||||
57471|NCT01236365|Secondary|Gene Expression and Concentration of Key Molecules That Participate in the Inflammatory Process and Arterial Plaque Formation.|We will restrict participation in protocol #2 to those with T1DM for >3 years and a HbA1C >8% using a stratified balanced randomization. Blood will be withdrawn for a special genetic test. Age-matched, non-diabetic healthy controls will be recruited for comparison.|6 months||||||
57472|NCT01236365|Secondary|Relationship Between Glycemic Variability- Measured by the Mean Amplitude of Glycemic Excursion With Continuous Glucose Monitoring.|At randomization, 3 and 6 months a CGM (IPro®, Medtronic Minimed) will be worn blindly for 6d to assess glucose variability to correlate mean amplitude of glycemic excursions (MAGE) with changes in Lp particles and hsCRP.|Randomization and 6 months||||||
57473|NCT01236365|Primary|LDL-C Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM is safe, improves measures of LDL-C. Subjects will have a physical exam, laboratories, nutritional counseling and moderate aerobic exercise recommended. Diabetes management will be intensified. At 3 months fasting lipoprotein fractions (ion mobility)re-drawn and if LDL-C >100mg/dl patients will be randomized to treatment with statins or placebo for 6 months, randomization stratified by BP and microalbuminuria, duration of diabetes and HgA1C. At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline.|Randomization and 6 months|Adjusted for age, gender and ISS (Insulin sensitivity score)||mg/dL||Standard Error|Mean
57474|NCT01236339|Secondary|Liver Disease Complications (Adverse Events)|Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding.|Through 24 months|||participants|||Number
57475|NCT01236339|Secondary|Procedural Success|"Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein~*Note: Control (LVP) arm includes only subjects who crossed over to TIPS"|Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)|||participants|||Number
57476|NCT01236339|Secondary|Frequency of Hepatic Encephalopathy|Number of episodes of West Haven grade 2 or greater|Through 24 months|||Number of episodes|||Number
57477|NCT01236339|Secondary|Frequency of Paracentesis|Number of paracentesis post randomization|Through 24 months|||Number of episodes|||Number
57478|NCT01236339|Secondary|Time to Transplant|"Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant.~*Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination."|Through 24 months|||participants|||Number
57479|NCT01236339|Secondary|Overall Survival|"Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. >~*Note: Outcome measure entered below is number of subjects alive at time of study termination."|Through 24 months|||participants|||Number
57480|NCT01236339|Primary|Transplant-free Survival|"Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up.~Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination."|Through 24 months|||participants|||Number
57481|NCT01236326|Secondary|Recovered by 2 Months After Donation||2 months|||participants|||Number
57482|NCT01236326|Secondary|Days to Normal Day-to-day Activities||2 months|||days||Standard Deviation|Mean
57483|NCT01236326|Secondary|Days Before Going Back to Work||2 months|||days||Standard Deviation|Mean
57484|NCT01236326|Secondary|Days on Oral Pain Medication After Discharge||2 months|||days||Standard Deviation|Mean
57485|NCT01236326|Primary|The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.|"The Primary Endpoint of the Study Will be Patient Self-reported Return to 100%, as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity."|1 year|||days||Standard Deviation|Mean
57486|NCT01236300|Primary|NPV (Negative Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
57487|NCT01236300|Primary|PPV (Positive Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
75600|NCT01050660|Secondary|Incidence of Bronchopulmonary Dysplasia (BPD)||36 weeks PMA or discharge home,whichever comes first|||participants who developed BPD|||Number
57488|NCT01236300|Primary|Specificity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
57489|NCT01236300|Secondary|Overall Complication Rate|Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure|August 2011|||percentage of participants||95% Confidence Interval|Number
57490|NCT01236300|Primary|Sensitivity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
57491|NCT01236196|Primary|Pain Intensity|Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
57492|NCT01236196|Primary|Pain Behavior|Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
57493|NCT01236196|Primary|Depressive Symptoms|Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
57494|NCT01236196|Primary|Level of Functioning|Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain||units on a scale||Standard Deviation|Mean
57495|NCT01236170|Secondary|Wheelchair Activity||over a two week period following baseline||||||
57496|NCT01236170|Secondary|Participation in Society|"We assessed participation in society with a modified version of the Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF). The CHART was designed to provide a simple measure of involvement in life situations (“In a typical week, how many days do you get out of your house and go somewhere?”) with sub-scales measuring physical independence, cognitive independence, mobility, occupation, social integration and economic self-sufficiency. The CHART-SF produces scores ranging from 0 (severe handicap) to 100 (no handicap) for each of the sub-scales and a total score ranging from 0-600. The CHART-SF is the most widely used participation measure in rehabilitation research. It has been used in various ethnic groups, and has well-established psychometric properties (test-retest reliability = .93; inter-rater reliability = .83). We dichotomized into Disabled and Not Disabled where disabled are those with a CHART score <100, and not disabled are those with a CHART score >=100"|Measured at baseline|452/482 participants were included in this analysis because 30 participants had missing data.||participants|||Number
57497|NCT01236170|Secondary|Satisfaction With Prescribed Wheelchair|We assessed Satisfaction with patients’ prescribe wheelchair using the Quebec User Evaluation of Satisfaction with assistive Technology ( (QUEST). We used an 8-item subset of the QUEST to assess patients’ satisfaction with their wheelchair. QUEST is the first and only standardized satisfaction assessment tool that was designed specifically for assistive technology devices. Its’ development was based on major theoretical models of assistive technology. The QUEST has been widely cited and used in clinical and research settings, and demonstrates strong psychometric properties (Cronbach’s alpha = .82). The 8 item subset focuses specifically on patients’ satisfaction with different aspects of their wheelchair (e.g., “How satisfied are you with the dimensions (size, height, length, width) of your assistive device?”). Responses range from 1(not satisfied at all) to 5(very satisfied). Cronbach’s alpha = .80 for the 8-item wheelchair subset. We chose to eliminate the other four items|one time use, at baseline|||units on a scale||Standard Deviation|Mean
57498|NCT01236170|Secondary|Satisfaction With Wheelchair Service Delivery|We assessed Satisfaction with Wheelchair Service Delivery using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily administered and scored measure of client satisfaction with services (e.g., “How would you rate the quality of service you have received?”). For the purpose of this study, we asked patients to focus specifically on satisfaction with service at their SCI or AL wheelchair clinic. The scale is unidimensional, yielding a homogenous estimate of general satisfaction with services. It is scored by summing the individual items and produces a score ranging from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has been extensively used in a variety of healthcare settings, operates similarly across ethnic groups, and demonstrates excellent psychometric properties (Cronbach’s alpha = .83-.93).|one time use, at baseline|||units on a scale||Standard Deviation|Mean
57597|NCT01235715|Primary|Units of Homologous Transfusion Over the Course of the Hospital Stay|Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|three days postoperatively|All patients who completed the study were included in analysis.||units||Standard Deviation|Median
57499|NCT01236170|Primary|Quality of Life|We will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12)and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach’s alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. We assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).|Measured at baseline|Only 468/482 participants were included in this analysis due to 14 participants having missing data.||units on a scale||Standard Deviation|Mean
57500|NCT01236118|Primary|Number of Participants With Adverse Events (AEs) [Clinically Significant Events]|Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.|Baseline through study completion (up to Week 56)|All enrolled participants.||participants|||Number
57501|NCT01236105|Secondary|Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276|Tmax, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.||hours (h)||Full Range|Median
57502|NCT01236105|Primary|Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,|Cmax estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
57503|NCT01236105|Primary|Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276|AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
57504|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57505|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57506|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57507|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57508|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57509|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57510|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57511|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57512|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57513|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57566|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.~VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.||participants|||Number
75601|NCT01050660|Secondary|Mortality Rate- Death Rate Before Discharge From the Hospital||Discharge from the Newborn ICU|||participants|||Number
57514|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57515|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57516|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57517|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was same as for case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57518|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was the same as case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57519|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
76587|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||52 weeks minus baseline|||mL/min/1.73m^2||Standard Deviation|Mean
57520|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57521|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57522|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57523|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57524|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57525|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57567|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 6 Months||6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.||mg/day of Vimpat||Standard Deviation|Mean
57568|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 3 Months||3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.||mg/day of Vimpat||Standard Deviation|Mean
57526|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57527|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR/95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57528|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57529|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57530|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57531|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57569|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at Baseline|Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.||mg/day of Vimpat||Standard Deviation|Mean
57532|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57533|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57534|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57535|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57536|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57537|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57570|NCT01235923|Primary|Reticulocyte Count|reticulocyte count at 4 weeks (end of study)|4 weeks|Power analysis based on difference in mean retic count (baseline versus 4 weeks) of 75 (standard deviation 50), alpha 0.05, 80% power.||cells x 1000/microliter||Standard Error|Mean
57538|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57539|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57540|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57541|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57542|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57543|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57571|NCT01235923|Primary|Baseline Retic Count|retic count measured at study entry|baseline|All study subjects had baseline retic count measured.||x1000 cells/microliter||Standard Error|Mean
57572|NCT01235910|Secondary|Blood Pressure||2 weeks||||||
57573|NCT01235910|Secondary|Aliskiren Plasma Concentrations|Maximum plasma concentration; area under the concentration-time curve, half-life, oral clearance|2 weeks||||||
57544|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57545|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57546|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57 -105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57547|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57548|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident Anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57549|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57598|NCT01235715|Primary|Number of Autologous Transfusion Units Over the Course of the Hospital Stay|Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|perioperatively|||units||Standard Error|Mean
57550|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57551|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.3-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 m.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57552|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip]), T 2 (3-7 prescrip), T 3 (8-298 prescrip). Tertiles without 2 yr lag: T 1 (1-2 prescrip), T 2 (3-7 prescrip), and T 3 (8-388 prescrip). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57553|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57554|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57555|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57574|NCT01235910|Primary|Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC)|The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.|7 days, 14 days, 30 days (End of Study)|||ng*h/ml/mg|||Number
62059|NCT01189227|Primary|Recurrence-free Survival (RFS)|Time to recurrence or death|From study entry until the date of recurrence or death or for a maximum of 5 years.||||||
57556|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57557|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57558|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.||participants|||Number
57559|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason|6 months|Of the 192 subjects in the Safety Set (SS), 168 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.||percentage of participants|||Number
57560|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.|3 months|Of the 192 subjects in the Safety Set (SS), 152 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.||percentage of participants|||Number
57561|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.~Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.||percentage of participants|||Number
57562|NCT01236001|Secondary|Treatment Persistence of VIMPAT® After 6 Months|Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (>=6 months).|>=6 months|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.||percentage of participants|||Number
57563|NCT01236001|Secondary|Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment|Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.|From baseline to study termination (6 months)|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.||percentage of patients|||Number
57564|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.||participants|||Number
57565|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.||participants|||Number
57596|NCT01235715|Secondary|Range of Motion at 6 Weeks|A measurement of the degrees of motion of the operated knee six weeks after surgery.|6 weeks postoperatively|Patients whose range of motion at 6-week followup appointment was taken were included in analysis.||degrees||Standard Deviation|Mean
57575|NCT01235897|Secondary|Best Disease Response by Response Evaluation Criteria in Solid Tumor (RECIST), Version 1.1|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD): Neither sufﬁcient shrinkage to qualify for PR nor sufﬁcient increase to qualify for PD, taking as reference the smallest sum diameters while on study~Non-PR/Non-PD: clinical response of chest wall disease not evaluable by RECIST"|60 days after dose inititation|Analysis included all patients receiving at least 8 weeks of study therapy||participants|||Number
57576|NCT01235897|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of MK-2206 Administered Weekly in Combination With Weekly Paclitaxel 80 mg/m^2 and Trastuzumab 2 mg/m^2|The MTD was defined as the dose level resulting in 3 or fewer DLTs in 11 patients, per the modified toxicity probability interval (TPI) method (Ji Y, Li Y, Nebiyou Bekele B: Dose-ﬁnding in phase I clinical trials based on toxicity probability intervals. Clin Trials 4:235-244, 2007), and confirmed in 4 additional patients. Based on interim toxicity data from other studies, the dose was not escalated beyond 135 mg weekly.|30 days from initiation of dose|Sixteen participants completed at least one cycle of therapy and were evaluable for DLT per protocol. Patients were assessed for DLT during the first 4-week cycle.||mg|||Number
57577|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.||mg/dL||Standard Deviation|Mean
57578|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.||mU/L||Standard Deviation|Mean
57579|NCT01235741|Primary|Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).|Baseline to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.||mg/dL||Standard Deviation|Mean
57580|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement.||beats/min||Standard Deviation|Mean
57581|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).|Baseline to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of drug treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement up to 6 Months follow-up.||mmHg||Standard Deviation|Mean
57582|NCT01235741|Primary|Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L; bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.||participants|||Number
57583|NCT01235741|Primary|Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large.|Screening to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. Number analyzed (n) in ITT included participants who provided a laboratory measurement. Hemoglobin, hematocrit n=27, 29 in placebo and pramlintide + metreleptin, respectively; urinalysis n=31, 29, in placebo and pramlintide + metreleptin, respectively.||participants|||Number
57584|NCT01235741|Primary|Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin|In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.|Baseline to Month 6 Follow-Up|||participants|||Number
57585|NCT01235741|Primary|Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population|Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.|Week 1 to Month 6 Follow-Up|All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28.||participants|||Number
57586|NCT01235741|Primary|Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population|Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).|Baseline to Month 6 Follow Up|All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively.||ng/mL||Standard Deviation|Mean
57587|NCT01235741|Primary|Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population|Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.|Day 1 up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment.||participants|||Number
57588|NCT01235741|Secondary|Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a measurement. Number analyzed (n) for Week 1 provided above; 6 Month Follow-Up n=27, 29, in placebo and Pramlintide + Metreleptin, respectively.||percentage of change in weight||Standard Deviation|Mean
57589|NCT01235728|Secondary|Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients|Plasma samples were collected at 12 hours post-dose on Days 8, 15, 22, and 28 to evaluate the mean maximum plasma concentration at trough of MK-0873.|Day 8, 15, 22, 29|The population consisted of all participants that received treatment, had no major protocol violations, and had MK-0873 plasma trough values available for the Day 8, 15, 22, and 28 treatment.||nM||Standard Deviation|Mean
57590|NCT01235728|Secondary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29||Percent Change|Participants|95% Confidence Interval|Least Squares Mean
57591|NCT01235728|Primary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of Target Lesion Severity (TLS) Score for Lesions Treated With MK-0873 and Lesions Treated With MK-0873 Vehicle|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29.||Percent Change|Participants|95% Confidence Interval|Least Squares Mean
57592|NCT01235715|Secondary|Visual Analog Pain Scale (At Night) At 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.|6 weeks postoperatively|||units on a scale||Standard Deviation|Mean
57593|NCT01235715|Secondary|Visual Analog Pain Scale (During Therapy) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.|6 weeks postoperatively|||units on a scale||Standard Deviation|Mean
57594|NCT01235715|Secondary|Visual Analog Pain Scale (During Activity) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.||units on a scale||Standard Deviation|Mean
57595|NCT01235715|Secondary|Visual Analog Pain Scale (at Rest) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.||units on a scale||Standard Deviation|Mean
57600|NCT01235715|Primary|Change in Hematocrit on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||percentage of red blood cell||Standard Deviation|Mean
57601|NCT01235715|Primary|Change in Hemoglobin on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||g/dL||Standard Deviation|Mean
57602|NCT01235715|Primary|Change in Hematocrit on Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||percentage of red blood cell||Standard Deviation|Mean
57603|NCT01235715|Primary|Change in Hemoglobin On Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||g/dL||Standard Deviation|Mean
57604|NCT01235715|Primary|Change in Hematocrit on Day 0 Compared to Preoperatively||preoperatively and day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||percentage of red blood cell||Standard Error|Mean
57605|NCT01235715|Secondary|Visual Analog Pain Scale on Day 3|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.|3 days postoperatively|||points on VAS scale||Standard Error|Mean
57606|NCT01235715|Secondary|Range of Motion on Day 3|A measurement of the degrees of motion of the operated knee three days after surgery.|3 days postoperatively|||degrees||Standard Error|Mean
57607|NCT01235715|Secondary|Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively|The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.|preoperatively and two days after surgery|All patients who completed the study were included in analysis.||ratio||Standard Deviation|Mean
57608|NCT01235715|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and on the day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.||g/dL||Standard Deviation|Mean
57609|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 2 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.~A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
57610|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 1 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.~A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
57611|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Changes in Hand Bone Mineral Density as Measured by Digital XRay (DXR) at Week 16|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with increases in bone mineral density at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
58292|NCT01227785|Primary|Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1month|68 CRT-D and 43 ICD patients had data available at 1month visit.||milli volt (mV)||Standard Deviation|Mean
57612|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Disease Activity Score-28 (DAS28 (CRP)) Response at Week 16|"The DAS28(CRP) was calculated using the tender joint count (TJC) and swollen joint count (SJC), C-Reactive Protein (CRP in mg/L) and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm).~A positive correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with reductions in DAS28(CRP) at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
57613|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 70 % Criteria (ACR70) at Week 16|"Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR70 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
57614|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 50 % Criteria (ACR50) at Week 16|"Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR50 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
57615|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 20 % Criteria (ACR20) at Week 16|"Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR20 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
57616|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.~Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28(CRP) > 5.1 and decrease from Baseline > 1.2~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with better EULAR responses."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.||Spearman rank correlation coefficient|||Number
57617|NCT01235598|Secondary|C-Reactive Protein (CRP) Ratio to Baseline at Week 16|"The C-Reactive Protein (CRP) is considered a marker of inflammation in subjects with Rheumatoid Arthritis.~A ratio to Baseline < 1 indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||ratio||Geometric Coefficient of Variation|Geometric Mean
57625|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Criteria (ACR50) at Week 16|Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
57618|NCT01235598|Secondary|Change From Baseline to Week 16 in Health Assessment Questionnaire - Disability Index (HAQ-DI)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject reported questionnaire that provides an assessment of the impact of the disease and its treatment on physical function. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question the level of difficulty is scored from 0 to 3 where 0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do. A total score is computed from the item scores using the scoring rules provided by the author (Fries, 1980). The total score ranges from 0 to 3 with lower scores meaning lower disability. A negative value in HAQ-DI change from Baseline indicates an improvement.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||scores on a scale||Standard Deviation|Mean
57619|NCT01235598|Secondary|Change From Baseline to Week 16 in Swollen Joint Count (SJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated None swelling response and Yes indicated that there was a detectable synovial thickening with or without loss of bony contours, or bulging synovial proliferation with or without cystic characteristics. If there were missing observations in the SJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. SJC ranges from 0 to 28 with 0 indicating no swollen joints and 28 indicating swelling in all joints. A negative value in SJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
57620|NCT01235598|Secondary|Change From Baseline to Week 16 in Tender Joint Count (TJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated Not tender; Yes indicated a positive tenderness response that was defined as a positive response to questioning (tender), spontaneous response elicited (tender and winced) or withdrawal by subject on examination (tender, winced, and withdrew). If there were missing observations in the TJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. TJC ranges from 0 to 28 with 0 indicating no tender joints and 28 indicating tenderness in all joints. A negative value in TJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
57621|NCT01235598|Secondary|Change From Baseline to Week 16 in Bone Mineral Density as Measured by Digital XRay (DXR)|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.~A positive value in Bone Mineral Density change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||g/cm^2||Standard Deviation|Mean
57622|NCT01235598|Secondary|Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 16|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.||percentage of subjects|||Number
57623|NCT01235598|Secondary|Change From Baseline to Week 16 in the Disease Activity Score-28 (C-Reactive Protein) (DAS28 (CRP)) Response|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. A negative value in DAS28[CRP] change from Baseline indicates an improvement from Baseline.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
57624|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Criteria (ACR70) at Week 16|Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
57695|NCT01234831|Primary|Completion of Screening Protocol in Both Trial Arms|Rate at which subjects in both trial arms complete the 3-swab protocol.|1 year|Participants in both the Active Screening arm and Passive Screening arm who completed the 3-swab protocol.||percentage of subjects completed 3 swabs|||Number
57626|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Criteria (ACR20) at Week 16|Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
57627|NCT01235598|Secondary|Percentage of Subjects Achieving a Good European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.~Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28(CRP) > 5.1 and decrease from Baseline > 1.2"|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.||percentage of subjects|||Number
57628|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Number of Voxels (Nvox) With Plateau and Washout Pattern|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in Nvox change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||voxels||Standard Deviation|Mean
57629|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Maximal Enhancement (ME)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in ME change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||percent change over pre-contrast||Standard Deviation|Mean
57630|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Initiation Rate of Enhancement (IRE)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in IRE change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||percent per second||Standard Deviation|Mean
57631|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
57632|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
57633|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 4|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
57634|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 8|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
57635|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.||scores on a scale||Standard Deviation|Mean
57636|NCT01235507|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24.|Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24|Safety Analysis Population: All participants enrolled in the study who received at least 1 dose of study medication and had at least 1 post-baseline assessment of safety (such as laboratory data, vital signs, or AEs) were included.||percentage of participants|||Number
57637|NCT01235507|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a marker of inflammation and is measured in millimeters per hour (mm/hour). A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm/hour||Standard Deviation|Mean
57638|NCT01235507|Secondary|CRP Levels|CRP is a marker of acute phase inflammation and is measured in mg/L. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mg/L||Standard Deviation|Mean
62905|NCT01181011|Secondary|Tmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Amlodipine||h||Standard Deviation|Mean
57639|NCT01235507|Secondary|Participant's Global Assessment of Pain|Participant's global assessment of pain was performed using a 100 mm VAS ranging from no pain (0) at the left edge to unbearable pain (100) at the right edge. The distance in mm from the left edge of the scale was measured. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm||Standard Deviation|Mean
57640|NCT01235507|Secondary|Participant's Global Assessment of Disease Activity|Participant's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm||Standard Deviation|Mean
57641|NCT01235507|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point||mm||Standard Deviation|Mean
57642|NCT01235507|Secondary|Swollen and Tender Joint Counts|66 and 68 joints were assessed by the physician for tenderness or swelling respectively. The joints were counted as tender/not tender (tender=1; not tender=0) and swollen/not swollen (swollen=1; not swollen=0) and scored. The scores ranged from 0 to 66 for TJC and 0 to 68 for SJC. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point||Joints||Standard Deviation|Mean
57643|NCT01235507|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28|"DAS28 was calculated using the 28 joints count, the CRP and PtGA of disease activity. The following formula was used to determine DAS28.~DAS28 = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100-mm VAS).~The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Participants were considered to have low disease activity when DAS28 was less than or equal to (≤) 3.2 and in clinical remission when DAS28 scores were less than (<) 2.6"|Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point||percentage of participants|||Number
57644|NCT01235507|Secondary|Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit|"DAS28 was calculated using the 28 joints count, the C-reactive protein levels (CRP) and participant's global assessment (PtGA) of disease activity. The following formula was used to determine DAS28.~DAS28 (equals) = 0.56 × (square root of) √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100- millimeter [mm] visual analog scale [ VAS]).~The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity."|Baseline, Weeks 8, 16 and 24|ITT Population; number (n) = number of participants analyzed for the given parameter at the specified time point||units on a scale||Standard Deviation|Mean
57645|NCT01235442|Secondary|sPGA (0,1) at Week 24|The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
57646|NCT01235442|Secondary|PASI 75 at Week 24|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
57647|NCT01235442|Secondary|Percent PASI Improvement From Baseline at Week 12|The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of Improvement in PASI score||Standard Deviation|Mean
57648|NCT01235442|Secondary|Patient Satisfaction at Week 12|Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication’s control of psoriasis, ranging from “very satisfied” to “very dissatisfied.”|Week 12|PRO analysis set, including all subjects randomized and also complete the baseline and at least 1 of the post-baseline PRO assessment with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
57649|NCT01235442|Secondary|PASI 90 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
57650|NCT01235442|Secondary|sPGA (0,1) at Week 12|The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
58795|NCT01222104|Secondary|Impact of Guided Access on Achieving Target Puncture Location.|The influence of fluoroscopy and/or ultrasound guided access on puncture location.|30 days|Deployed subjects with readable angiograms||% within target zone|||Number
57651|NCT01235442|Primary|PASI 75 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation||Percentage of participants|||Number
57652|NCT01235403|Secondary|Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period|"The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.~The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase."|End of Treatment Period (24-week)|Safety Set||percentage of subjects|||Number
57653|NCT01235403|Primary|Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study|Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study (up to 24 - 28 weeks)|Safety Set||subjects|||Number
57654|NCT01235403|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study|Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study ( up to 24 - 28 weeks)|Safety Set||subjects|||Number
57655|NCT01235377|Secondary|Factors Associated With Prescribing Patterns|factors (barriers and facilitators) associated with prescribing according to the Cluster Designation|nine months||||||
57656|NCT01235377|Primary|Prescription Rates|rates of provider prescribing of the Cluster Designated drug|nine months|providers prescribing a thiazide at least once in the study period||% new thiazide prescriptions||Inter-Quartile Range|Median
57657|NCT01235338|Secondary|Pulse Rate||Baseline and up to 39 days|SAS||bpm||Standard Deviation|Mean
57658|NCT01235338|Primary|Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
57659|NCT01235338|Primary|Tmax of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
57660|NCT01235338|Primary|Tmax of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
57661|NCT01235338|Primary|Tmax of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
57662|NCT01235338|Primary|Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS||hours||Standard Deviation|Mean
57663|NCT01235338|Primary|AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
57664|NCT01235338|Primary|AUC of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
57665|NCT01235338|Primary|AUC of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
57666|NCT01235338|Primary|AUC of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
57667|NCT01235338|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS||ng*hr/ml||Standard Deviation|Mean
57668|NCT01235338|Primary|Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
57669|NCT01235338|Primary|Cmax of o-Desmethylvenlafaxine|Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.|Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
57670|NCT01235338|Secondary|Diastolic Blood Pressure||Baseline and up to 39 days|SAS||mmHg||Standard Deviation|Mean
57671|NCT01235338|Secondary|Systolic Blood Pressure||Baseline and up to 39 days|Safety Analysis Set (SAS) defined as all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||mmHg||Standard Deviation|Mean
57672|NCT01235338|Primary|Cmax of Venlafaxine Hydrochloride|Venlafaxine Hydrochloride is the active ingredient of Effexor XR|Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
57673|NCT01235338|Primary|Cmax of d-Amphetamine|d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|PAS||ng/ml||Standard Deviation|Mean
57674|NCT01235338|Primary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|Pharmacokinetic Analysis Set (PAS) defined as all subjects who took a t least 1 dose of investigational product and had at least 1 post-dose safety assessment and who had no major deviations related to investigational product intake (e.g. vomiting) and for whom the primary pharmacokinetic data were considered sufficient and interpretable.||ng/ml||Standard Deviation|Mean
57675|NCT01235234|Secondary|Ocular Surface Disease Index|Change from Baseline in Ocular Surface Disease Indexat Week 24|24 weeks||||||
57676|NCT01235234|Secondary|Increase in Schirmer Test Tearing by >9mm Over Baseline|Proportion of subjects with ST wetting increase over Baseline of ≥10 mm with or without anesthesia in either eye at Week 24|24 weeks||||||
57677|NCT01235234|Primary|Nature and Frequency of Adverse Events|The primary efficacy comparison with respect to the rates of complete clearing of corneal staining at Week 24 was performed using a 2-sided test at level 0.025 to adjust for the comparison of 2 doses of CF101 to placebo. All between-treatment comparisons with respect to all secondary efficacy endpoints were performed using 2-sided tests at level 0.025. Between-treatment comparisons with respect to ancillary efficacy endpoints were performed using 2-sided tests at level 0.05. The primary comparison, as well as the comparisons with respect to the proportion of subjects with complete central corneal clearing (i.e., central corneal FS score=0) in the target eye and the proportion of subjects with ST ≥10 mm with or without anesthesia in either eye, was performed using the Cochran-Mantel-Haenszel test, stratified by duration of symptoms at Baseline (≤5 years or>5 years) and disease severity at Baseline (ST1-3or4-6 mm/5 minutes without anesthesia).|24 weeks||||||
57678|NCT01235234|Primary|Efficacy by Proportion of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24|Complete clearing of corneal staining by fluorescein staining (FS). The primary efficacy analysis was performed for 1eye (target eye), defined as the eye with the larger corneal FS value at Baseline. If both eyes had the same corneal FS value at baseline, the target eye was considered the eye with the larger central corneal staining value at Baseline. Corneal FS defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale|24 weeks|||participants|||Number
57679|NCT01235195|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||hours||Standard Deviation|Mean
57680|NCT01235195|Secondary|Residual Area Under the Concentration Time Curve [AUC(Res%)]|AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|This parameter was not analyzed. It is reported individually for each subject and not analyzed statistically.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
57681|NCT01235195|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||ng*h/mL||Standard Deviation|Mean
57682|NCT01235195|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||hours||Full Range|Median
57683|NCT01235195|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
57684|NCT01235195|Primary|Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]|AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics.||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
57685|NCT01234922|Secondary|Change in Ang II, VEGF, PlGF, and ACE Levels||1 week||||||
57686|NCT01234922|Primary|Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter||7 days post-baseline|||Picogram/milliliter||Standard Deviation|Mean
57687|NCT01234883|Primary|Venous Serum Bicarbonate: Modified Intent to Treat Population (mITT); Obtained at Hour 4|The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus at Hour 0.|4 hour|The mITT population is all subjects with Baseline bicarbonate value ≤ 22 mmol/L. The mITT population was used for efficacy evaluation. The AT analysis set was defined as all subjects who received at least 5 mL of study treatment and were classified according to actual treatment received. AT population was used for AE analysis.||mmol/L||Standard Deviation|Mean
57688|NCT01234870|Secondary|Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol|Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.|14 days|||occurances of adverse events|||Number
57689|NCT01234870|Primary|Magnetic Resonance Image Quality Rating|The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality|Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.|||units on a likert scale||Standard Deviation|Mean
57690|NCT01234831|Secondary|Rate of Recolonization or Documented Infection With MRSA|Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection.|2 years||||||
57691|NCT01234831|Secondary|Specificity of First PCR Assay.|Specificity of the first PCR assay for subjects enrolled in active arm of trial.|1 year|||percentage of true negatives||95% Confidence Interval|Number
57692|NCT01234831|Secondary|Sensitivity of First PCR Assay|Sensitivity of the first PCR assay for subjects enrolled in active arm of trial.|1 year|||percentage of true positives||95% Confidence Interval|Number
57693|NCT01234831|Secondary|Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay|This outcome is the positive predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization who completed the 3 swab protocol.|1 year|Number of participants in the Active Screening arm who had completed the 3-swab protocol.||participants|||Number
57694|NCT01234831|Primary|Discontinuation of Contact Precautions in Both Trial Arms|"Patients known to have MRSA require Contact Precautions based on current recommendations from the Center for Disease Control and Prevention (CDC). Contact Precautions mean that hospitalized patients with a history of MRSA infection or colonization are isolated in a private room or together with patients who have the same Contact Precautions status (i.e. both with MRSA). Healthcare workers caring for such patients must wear protective gowns and gloves during interactions and use of equipment dedicated to that patient is recommended. For this study, Contact Precautions are discontinued refers to the practice of discontinuation of Contact Precautions once subjects meet criteria based on institutional infection control policy: history of MRSA but no positive culture in preceding 90 days and three negative nasal surveillance cultures obtained at least 24 hours apart in the absence of concurrent antibiotic use."|1 year|Analysis was performed on patients in both the Active Screening arm and Passive Screening arm who had completed the 3-swab protocol and all 3 swabs were negative.||percentage of MRSA CP discontinued|||Number
57696|NCT01234831|Primary|Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays|This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization.|1 year|Only patients randomized to the Active Screening arm who had 3 pairs of completed nasal swabs could be analyzed for this outcome measure which is the negative predictive value of the first PCR sample compared to three culture samples for subjects with a history of prior MRSA infection or colonization.||percentage of participants||95% Confidence Interval|Number
57697|NCT01234714|Secondary|Type of Post-operative Complications|There are several different types of post-operative complications associated with liver surgery, such as liver failure, multi-organ failure, bleeding, bile leak, and sepsis.|December 2010||||||
57698|NCT01234714|Secondary|Cost|The total in-hospital costs were calculated for each patient in Euros.|December 2010|According to MRI||Euros||Standard Deviation|Mean
57699|NCT01234714|Secondary|Hospital Stay|The patient hospital stay was calculated according to the total number of days the patient was hospitalized.|December 2010|According to MRI||days||Inter-Quartile Range|Median
57700|NCT01234714|Secondary|Intensive Care Unit (ICU) Stay|The Intensive Care Unit (ICU) stay was calculated according to the total number of days the patients were managed in the ICU. This included also multiple ICU admissions.|December 2010|According to MRI||days||Inter-Quartile Range|Median
57701|NCT01234714|Secondary|Operative Time|The operation duration was measured according to the total minutes from the beginning of the operation until the end.|December 2010|According to MRI||min||Inter-Quartile Range|Median
57702|NCT01234714|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.|December 2010|According to MRI||ml||Inter-Quartile Range|Median
57703|NCT01234714|Secondary|Post-operative Alanine Transaminase (ALT) Levels|Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.|December 2010|According to the MRI liver fat content measurement.||Units/liter||Inter-Quartile Range|Median
57704|NCT01234714|Primary|Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)|"Liver fat content, measured by MRI, uses the in-phase/out-of-phase imaging calculated in terms of fat signal fraction (FSF).~The Clavien-Dindo Classification of Surgical Complications:~Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient"|December 2010|According to the Clavien-Dindo Classification of surgical complications: (please see) http://www.surgicalcomplication.info/||Percentage of liver fat content||Inter-Quartile Range|Median
57705|NCT01234675|Primary|Percentage of Total Sleep Time|Sleep measures at week 5 of the treatment period I; and upto week 12 for treatment period II Percentage of Total Sleep Time that was spent in various stages of sleep|Overnight PSG week 5/ up to week 12; milnacipran treatment|||Percent of total sleep time||Standard Error|Mean
57706|NCT01234675|Primary|Arousal Index|Number of arousal per hours|Overnight PSG week 5/ upto week 12; milnacipran treatment|||Number of Arousals per hour||Standard Error|Mean
57707|NCT01234675|Primary|Sleep Efficiency|Percentage of Total sleep time|Overnight PSG week 5/ upto week 12; milnacipran treatment|||Percentage of total sleep time||Standard Error|Mean
57708|NCT01234675|Primary|Number of Awakenings After Sleep Onset||Overnight PSG week 5/ upto week 12; milnacipran treatment|||Number of Awakenings||Standard Error|Mean
57709|NCT01234675|Secondary|Subjective Measures With Change in Sleep and Change in Pain Measures|"Subjective assessments will constitute secondary endpoints and will include:~• Clinical Global Impression Improvement of Illness Scale (CGI-I) Clinical Global Impression- Severity of Illness scale (CGI-S); Medical Outcomes study Sleep Scale (MOS-SS); Fibromyalgia impact questionnaire (FIQ); Brief Pain Inventory (BPI) score-short form; Patient Global Impression of change (PGI-C); Beck Depression Inventory (BDI; Fatigue Severity Scale (FSS; Numeric Rating Scale-Sleep (NRS-S), part of subjective sleep questionnaire"|assessments made at week 1, week 6, week 14||||||
57710|NCT01234675|Primary|Overnight Polysomnography to Measure Sleep Disturbance With Milnacipran Treatment|Sleep measures at week 5 of the treatment period I; and upto week 12 for treatment period II|Overnight PSG week 5/ up to week 12; milnacipran treatment|||minutes||Standard Error|Mean
57711|NCT01234337|Other Pre-specified|Number of Participants With Treatment-emergent Grade 3 and 4 Laboratory Abnormalities|Hematological (anemia, hemoglobin, international normalized ratio [INR], lymphocyte, neutrophil, platelet, white blood cell [WBC]), biochemical (ALT [alanine aminotransferase], AST [aspartate aminotransferase], GGT [gamma-glutamyl-transferase], lipase, hypoalbuminemia, hypocalcemia, hyperglycemia, hyperuricemia) evaluations were done. Common terminology criteria for adverse events (CTCAE) version 4-Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization and CTCAE version 4-Grade 4: life-threatening consequences; urgent intervention were indicated.|From the start of study treatment up to 30 days after the last dose|Safety Analysis Set (SAF) was comprised of all randomized participants who received at least one dose of study medication (sorafenib, placebo or capecitabine). Participants were analyzed as treated.||Paricipants|||Number
57712|NCT01234337|Other Pre-specified|Area Under Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Capecitabine and 5-fluorouracil|AUC(0-tlast) is defined as AUC from time 0 to the last data point, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|PKS||milligram*hour per liter||Geometric Coefficient of Variation|Geometric Mean
57713|NCT01234337|Other Pre-specified|Maximum Observed Drug Concentration (Cmax) of Capecitabine and 5-fluorouracil|Maximum observed drug concentration, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|Pharmacokinetic Analysis Set (PKS) included all participants with a valid pharmacokinetic profile of capecitabine.||milligram per liter||Geometric Coefficient of Variation|Geometric Mean
76588|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||12 weeks minus baseline|||mL/min/1.73m^2||Standard Deviation|Mean
57714|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D was a generic QoL preference based instrument and has been validated in the cancer populations. VAS was generated from 0 (worst imaginable health state) to 100 (best imaginable health state). This VAS score was referred to as the EQ-5D self-reported health status score. The results on ANCOVA of time-adjusted AUC were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.||Scores on a scale||95% Confidence Interval|Least Squares Mean
57715|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D was a generic Quality of life (QoL) based instrument validated in cancer populations. EQ-5D questionnaire contained a 5-item descriptive system of health states (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and visual analogue scale (VAS). A single HRQoL score ranging from -0.59 to 1 was generated from standard scoring algorithm developed by the EuroQoL was the EQ-5D index score, higher scores represent better health status. A change of at least 0.10 to 0.12 points was considered clinically meaningful. The results on the ANCOVA of time-adjusted AUC for the EQ-5D - Index Score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.||Scores on a scale||95% Confidence Interval|Least Squares Mean
57716|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy-Breast Symptom Index (8 Item) (FBSI-8)|The FBSI-8 was an 8-item questionnaire. Participants responded to each item using a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). A total scale score was calculated (range from 0 to 32), with higher scores indicating low symptomatology and reflecting a better Health-Related Quality of Life (HRQoL). The results on the analysis of covariance (ANCOVA) of time-adjusted area under curve (AUC) for the FBSI-8 score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, 31, 34, 37, and end of treatment (EOT, 21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.||Scores on a scale||95% Confidence Interval|Least Squares Mean
57717|NCT01234337|Secondary|Duration of Response (DOR) by Central Reader|DOR was defined as the time from date of first response (CR or PR) to the date when PD is first documented, or to the date of death, whichever occurred first according to RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. DOR defined for confirmed responders only (that is, CR or PR). 'NA' indicates that value could not be estimated due to censored data. Median and 95% CIs were computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|Only responders in FAS were evaluated for this outcome measure.||days||95% Confidence Interval|Median
57718|NCT01234337|Secondary|Disease Control Rate (DCR) by Central Review|DCR was defined as the proportion of participants whose best response was CR, PR, stable disease (SD) or Non-CR/Non-PD. Per RECIST version 1.1, CR=all target lesions disappeared, any pathological lymph node, target/non-target, a reduction in short axis to <10 mm. PR=at least 30% decrease in the sum of diameters of target lesions taking as reference baseline sum diameters. PD=at least 20% increase in the sum of diameters of the target lesions, taking as a reference smallest sum on study. Appearance of new lesions and unequivocal progression of existing non-target lesions. SD=neither sufficient shrinkage qualified for PR nor sufficient increase qualified for PD, taking smallest sum of diameters as a reference. Non-CR/Non-PD=persistence of 1/more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. DCR=CR+PR+SD or Non-CR/Non-PD. CR and PR confirmed by another scan at least 4 weeks later. SD and Non-CR/Non-PD documented at least 6 weeks after randomization.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS||percentage (%) of participants||95% Confidence Interval|Number
57719|NCT01234337|Secondary|Objective Response Rate (ORR) by Central Review|ORR was defined as the best tumor response (Complete Response [CR] or Partial Response [PR]) observed during treatment or within 30 days after termination of study treatment, assessed according to the RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR=CR+PR. CR and PR were confirmed by another scan at least 4 weeks later.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS||Percentage (%) of participants||95% Confidence Interval|Number
57720|NCT01234337|Secondary|Time to Progression (TTP) by Central Review|TTP was defined as the time from date of randomization to disease radiological progression by central review. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS||days||95% Confidence Interval|Median
58186|NCT01227993|Secondary|Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in micrograms.|Baseline and 2 years|||µg||Standard Deviation|Mean
57721|NCT01234337|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last known alive date. Median and other 95% CIs computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later|FAS||days||95% Confidence Interval|Median
57722|NCT01234337|Primary|Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1|PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years or until disease radiological progression|Full Analysis Set (FAS), also considered as Intent-to-treat (ITT) set, was defined as all randomized participants even if randomized but received no drug or if randomized and initially received incorrect drug prior to switching to correct study drug, these were included in FAS.||days||95% Confidence Interval|Median
57723|NCT01233999|Primary|Mean Digital Temperature Difference From Baseline|Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.|6 weeks|||Celsius||95% Confidence Interval|Mean
57724|NCT01233921|Secondary|Changes in the Number of Naive CD4 T Cells in the Blood|Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin|||cells per microliter of blood||Standard Deviation|Mean
57725|NCT01233921|Primary|Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood|RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin|||cells per microliter of blood||Standard Deviation|Mean
57726|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECGs were centrally evaluated. ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (≥)300 milliseconds (msec) or ≥25% increase when baseline is greater than (>)200 msec and ≥50% increase when baseline is less than or equal to (≤)200 msec; QRS interval ≥200 msec or ≥25%/50% increase from baseline; and QTcF ≥450 msec or ≥30 msec increase.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.||participants|||Number
57727|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.||participants|||Number
57728|NCT01233869|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
57729|NCT01233869|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
57743|NCT01233869|Secondary|Time to First Occurrence of Gross Hematuria|Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
76589|NCT01036490|Secondary|Change in Albuminuria||52 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
57730|NCT01233869|Secondary|Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25|The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life.|Baseline and end of ITPV (Month 25)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout); n=the number of participants analyzed in the respective arms.||units on a scale||Standard Deviation|Mean
57731|NCT01233869|Secondary|Observed Accumulation Ratio (Rac) of Bosutinib|Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1).|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ratio||Geometric Coefficient of Variation|Geometric Mean
57732|NCT01233869|Secondary|Terminal Elimination Half-Life (t1/2) of Bosutinib|t1/2 is the time measured for the plasma concentration to decrease by one half.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore t1/2 was not reported.|||||
57733|NCT01233869|Secondary|Apparent Volume of Distribution (Vz/F) of Bosutinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore Vz/F was not reported.|||||
57734|NCT01233869|Secondary|Apparent Oral Clearance (CL/F) of Bosutinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
57735|NCT01233869|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib||Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
57736|NCT01233869|Secondary|Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib|Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
57737|NCT01233869|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.||hours||Full Range|Median
57738|NCT01233869|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
57739|NCT01233869|Secondary|Number of Participants With High Serum Creatinine (SCr) Levels|A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
57740|NCT01233869|Secondary|Number of Participants With High Blood Urea Nitrogen (BUN) Levels|A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.||participants|||Number
57741|NCT01233869|Secondary|Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days|ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
57742|NCT01233869|Secondary|Time to First Occurrence of Proteinuria|Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
57744|NCT01233869|Secondary|Time to First Occurrence or Worsening of Back and/or Flank Pain|The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease [PKD]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
57745|NCT01233869|Secondary|Time to First Occurrence or Worsening of Hypertension|The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).||days|||Number
57746|NCT01233869|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination|eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.|Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination|The mITT population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment; n=the number of participants analyzed at that time point in the respective arms.||mL/min/1.73m^2||Standard Deviation|Mean
57747|NCT01233869|Primary|Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25|TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).|Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])|The modified intent-to-treat (mITT) population included all participants who were randomized and received at least 2-weeks' worth of treatment and have at least 1 follow-up MRI assessment that was preceded by a 1-month washout of the study drug; n=the number of participants analyzed at that time point in the respective arms.||centimeter cube (cm^3)||Standard Deviation|Mean
57748|NCT01233817|Primary|Strength|Primary Outcome Measure was muscle strength. Strength was measured using a fixed myometry evaluation, quantitative muscle analysis (QMA). QMA utilizes a relative fixed point for the participant to exert effort. Each muscle of interest was tested using QMA.|12 weeks|||kilograms||95% Confidence Interval|Median
57749|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 4|Number of participants with infectious complications is provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||participants|||Number
57750|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 3|The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||number of new cases per 1000 days|||Number
57751|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 2|Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||participants|||Number
57752|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 1|Infectious complication incidence rate per 100 days of treatment are provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||percentage of patients with infection|||Number
57753|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2|"This table shows the rates of:~Controls analysis on 80-150 mg/dL: optimal level of glycemia rate.~Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate.~Hypoglycemia (<50 mg/dL): severe hypoglycemia episodes rate."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||% of capillary glycemia measurements|||Number
57754|NCT01233726|Primary|Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1|This table shows the number of capillary glycemia measurements|28 days post-admission|||number of capillary glycemia measurement|||Number
57755|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 5|"The variables recorded related to Glycemic CV (%) are provided in this table:~Glycemic Coeficient of variation (%) after 28 days in ICU~Glycemic Coeficient of variation (%) after 7 days in ICU."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||percentage of Glycemic CV||Standard Deviation|Mean
57756|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 4|The variables recorded related to the number of measurements per patient per day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||Measurements per patient/day||Standard Deviation|Mean
57757|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 3|The variables recorded related to number of capillary glycemia measurements are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||Capillary glycemia measurements|||Number
57758|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 2|The variables recorded related to administered insulin in IU/day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||IU/day||Standard Deviation|Mean
57759|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 1|The variables recorded related to glycemic control in mg/dL are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.||mg/dL||Standard Deviation|Mean
57760|NCT01233687|Secondary|Overall Survival (OS)|Overall Survival was computed for all participants and is defined as the time between start of treatment and death. The (median) length of time in months that subjects with previously-treated advanced NSCLC, treated with the combination of AMG 102 and erlotinib, remain alive estimated by the Kaplan-Meier method.|Up to 24 months (after the first evaluable patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||months||90% Confidence Interval|Median
57761|NCT01233687|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from the start of treatment until first evidence of disease progression, death, or date of last contact. The (median) length of time that subjects with previously-treated advanced NSCLC, who were treated with the combination of AMG 102 and erlotinib, are both alive and free of disease progression as estimated by the Kaplan-Meier method. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Up to 24 months (after the first patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||months||90% Confidence Interval|Median
57762|NCT01233687|Secondary|Objective Response Rate (ORR/Clinical Response)|Using RECIST v1.1 criteria, ORR was determined by following equation: the number of partial response (PR) participants / the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Up to 6 months|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||percentage of patients||90% Confidence Interval|Number
57763|NCT01233687|Primary|Disease Control Rate (DCR)|Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Six weeks from initiation of treatment with AMG 102 + Erlotinib|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)||percentage of patients||90% Confidence Interval|Number
57764|NCT01233687|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity|Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.|During first cycle of treatment (3 weeks)|In the absence of DLTs among the first 7 pts treated, AMG 102 + Erlotinib (150 mg) daily (3 weeks) was declared the RP2D.||percentage of participants||90% Confidence Interval|Number
57765|NCT01233284|Secondary|FVC Area Under the Curve Within 24 Hours (h) Response (FVC AUC0-12h, FVC AUC12-24h, FVC AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-12, FVC AUC12-24 and FVC AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.||Litres||Standard Error|Mean
57766|NCT01233284|Secondary|FEV1 Area Under the Curve Within 24 Hours (h) Response (FEV1 AUC0-12h, FEV1 AUC12-24h, FEV1 AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-12, FEV1 AUC12-24 and FEV1 AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.||Litres||Standard Error|Mean
57767|NCT01233284|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for nighttime awakenings||Night awakenings||Standard Error|Mean
57768|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.||Puffs||Standard Error|Mean
57769|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.||Puffs||Standard Error|Mean
57770|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.||Puffs||Standard Error|Mean
57771|NCT01233284|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent . Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and 4 weeks|FAS reduced to patients with non-missing morning and evening PEF data.||Percentage of the mean daily PEF||Standard Error|Mean
57772|NCT01233284|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing evening PEF data.||Litre/min||Standard Error|Mean
57773|NCT01233284|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing morning PEF data.||Litre/min||Standard Error|Mean
57774|NCT01233284|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing PEF data.||Litre/min||Standard Error|Mean
57775|NCT01233284|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
57776|NCT01233284|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Mean
57777|NCT01233284|Secondary|FVC AUC0-3h Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
57778|NCT01233284|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FVC was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
57779|NCT01233284|Secondary|Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.||Litre||Standard Error|Mean
57780|NCT01233284|Secondary|FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Mean
57781|NCT01233284|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Mean
76590|NCT01036490|Secondary|Change in Albuminuria||12 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
57782|NCT01233284|Primary|Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response|Mixed model repeated measurement (MMRM) results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|Full analysis set (FAS) reduced to patients with non-missing FEV1 data. The FAS is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.||Litre||Standard Error|Mean
57783|NCT01233258|Other Pre-specified|Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of rFVIII (BAY81-8973)|3, 6, 9 and 12 months after baseline|Safety population||Participants|||Number
57784|NCT01233258|Other Pre-specified|Number of Bleeds During Treatment|The number of bleeds experienced by each participant|12 months|ITT||Bleeds||Inter-Quartile Range|Median
57785|NCT01233258|Secondary|Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973)|The percentage of bleeds per participant on on-demand treatment that stopped after two or fewer injections|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT||Percentage of bleeds||Full Range|Median
57786|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/ADJ Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/ADJ|Up to 6 months (6 months on CS/ADJ potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.||Bleeds per year per participant||Standard Deviation|Mean
57787|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/EP Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/EP|Up to 6 months (6 months on CS/EP potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.||Bleeds per year per participant||Standard Deviation|Mean
57788|NCT01233258|Primary|Annualized Number of All Bleeds|The annualized number of bleeds experienced by participants|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT (Intent to Treat). Low and high dose prophylaxis arms and both potencies combined as planned for the statistical analysis to achieve intended sample size.||Bleeds per year per participant||Standard Deviation|Mean
57789|NCT01233232|Secondary|Maximum Reduction of Circulating Neutrophils in Blood, From Baseline|The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.|Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)|||10^9/L cells/L||Standard Deviation|Mean
57790|NCT01233232|Secondary|Time to Maximum Plasma Concentration for AZD5069|Time (in relation to dosing) at which the maximum plasma concentration is observed.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing|||hours||Inter-Quartile Range|Median
57791|NCT01233232|Secondary|Maximum Plasma Concentration for AZD5069|The maximum plasma concentration (Cmax) is the highest level of drug in plasma.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
57792|NCT01233232|Secondary|Area Under the Plasma Concentration Curve of AZD5069|The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
57793|NCT01233232|Secondary|Plasma Concentration of AZD5069 After 1 Hour of Dosing|At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.|End of Treatment (Day 28), 1 hour after dosing|||nmol/L||Standard Deviation|Mean
57794|NCT01233232|Primary|Change From Baseline to End of Treatment for Total Protein (Urinalysis)|The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||g/L||Standard Deviation|Mean
57795|NCT01233232|Primary|Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)|High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).|Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])|||Participants|||Number
57796|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)|The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||L||Standard Deviation|Mean
57797|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)|The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||L||Standard Deviation|Mean
57798|NCT01233232|Primary|Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)|The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||beats/minute||Standard Deviation|Mean
57799|NCT01233232|Primary|Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)|The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||mmHg||Standard Deviation|Mean
57800|NCT01233232|Primary|Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)|The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||mmHg||Standard Deviation|Mean
57801|NCT01233232|Primary|Change From Baseline to End of Treatment for Body Temperature|The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||degrees C||Standard Deviation|Mean
57802|NCT01233232|Primary|Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)|The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||10^9/L cells/L||Standard Deviation|Mean
57803|NCT01233232|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)|||Participants|||Number
57804|NCT01233232|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Last Observation on Treatment (up to Day 28)|||Participants|||Number
57805|NCT01233232|Primary|Patients Who Experienced at Least One Adverse Events(s)|Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|From start of treatment (Day 0) up to 28 days (End of Treatment)|||Participants|||Number
57806|NCT01233076|Primary|Overall Vision Quality|Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
57807|NCT01232920|Secondary|Number of Eyes With Resolution of Macular Edema||6 months|||Eyes|Participants||Number
57808|NCT01232920|Secondary|Change in Best Spectacle-corrected Visual Acuity (BSCVA)|Change in best spectacle-corrected visual acuity (BSCVA) from baseline. Analysis on eye level|6 months|||LogMAR|Participants|Standard Deviation|Mean
57809|NCT01232920|Secondary|Time to Control of Inflammation||6 months|||days||Inter-Quartile Range|Median
57810|NCT01232920|Primary|Number of Participants Achieving Treatment Success|"TREATMENT SUCCESS is defined as controlled ocular inflammation in both eyes with less than or equal to 10 mg/day of prednisone and/or 2 topical steroid drops/day sustained for 2 visits separated by at least 28 days (control of inflammation and prednisone dose must be achieved by 5-month visit and sustained until 6-month visit).~Discontinuation of study medication at any time due to efficacy, tolerability, or safety may result in a declaration of TREATMENT FAILURE. Note that all patients will be classified as either a treatment success or failure."|6 months|||participants|||Number
57811|NCT01232894|Primary|Change From Baseline on Clinical COPD Questionnaire (CCQ) Score|The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.|Baseline and 12 weeks|Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis.||units on a scale||Standard Deviation|Mean
57812|NCT01232868|Secondary|Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures|The secondary outcomes will identify the number of participants with a positive B cell response to the flu shot particulary looking for antibody responses, presence of plasmablasts, antibody repertoire.|2 years|||participants|||Number
57813|NCT01232868|Primary|Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures|The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.|Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)|||participants|||Number
57814|NCT01232829|Secondary|Time to Disease Progression|Eighteen patients were evaluable for the time to disease progression endpoint.|From registration to documentation of disease progression, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the progression-free survival.||months||95% Confidence Interval|Median
57815|NCT01232829|Secondary|Survival|Survival was estimated using the Kaplan-Meier (1958) method.|From registration to death due to any cause, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the overall survival endpoint.||months||95% Confidence Interval|Median
57816|NCT01232829|Primary|Survival Rate|The primary endpoint of the study was 6-month survival. The proportion of successes was estimated by the number of successes divided by the total number of evaluable patients.|6 months|All patients meeting the eligibility criteria and who received treatment were considered evaluable for the primary endpoint. All patients treated per protocol (n=18) were evaluable for the 6-month survival endpoint.||participants|||Number
57825|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 1st Leg of Crossover|Per protocol||units on a scale||Standard Deviation|Mean
57817|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Change from PreScreening at End of Trial|Analyses only used matched cases and does not include participants with incomplete data.||units on a scale||Standard Deviation|Mean
57818|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|End of Trial|Per protocol||units on a scale||Standard Deviation|Mean
57819|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Pre Screening|Per protocol||units on a scale||Standard Deviation|Mean
57820|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Per protocol||units on a scale||Standard Deviation|Mean
57821|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.||units on a scale||Standard Deviation|Mean
57822|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Per protocol||units on a scale||Standard Deviation|Mean
57823|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those dropped out from the study.||units on a scale||Standard Deviation|Mean
57824|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
57861|NCT01232504|Secondary|Relapse Related Mortality|Relapse related mortality after a median follow-up of 600 days.|3～1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
57862|NCT01232504|Secondary|IFD Related Mortality|IFD-related mortalities after a median follow-up of 600 days.|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants||95% Confidence Interval|Number
57826|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Change from Baseline at Follow Up (Baseline - Follow Up)|Subjects analyzed are those with complete data at all timepoints and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
57827|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 1st Leg of Crossover (5 Days)|Per protocol||units on a scale||Standard Deviation|Mean
57828|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up in the crossover and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
57829|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).||units on a scale||Standard Deviation|Mean
57830|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at 2nd follow up in the crossover and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
57831|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.||units on a scale||Standard Deviation|Mean
57832|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
57833|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
57834|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Change from Baseline at Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
58796|NCT01222104|Secondary|Impact of Guided Access on Use of Closure Device.|The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.|30 days|Percentage of procedures with devices deployed||% of procedures using a closure device|Participants||Number
57835|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
57836|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).||units on a scale||Standard Deviation|Mean
57837|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
57838|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Change from Baseline at Follow Up (5 days)|Subjects analyzed are only those with complete data at baseline and 5 day follow up in the study.||units on a scale||Standard Deviation|Mean
57839|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.||units on a scale||Standard Deviation|Mean
57840|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline|Subjects analyzed are those with complete data at baseline prior to dropout from the study.||units on a scale||Standard Deviation|Mean
57841|NCT01232569|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||g/L||Standard Deviation|Mean
57842|NCT01232569|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
58014|NCT01230788|Primary|Remission Induction Rate|To estimate the remission induction rate of the addition of rituximab to cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one month|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
57843|NCT01232569|Secondary|Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
57844|NCT01232569|Secondary|Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients|||Number
57845|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
57846|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
57847|NCT01232569|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
57848|NCT01232569|Secondary|Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
57863|NCT01232504|Primary|Incidences of Invasive Fungal Diseases (IFD)|The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation|100 day post transplant|The number of intention-to-treat patients is 206. The incidence of invasive fungal infection analysis within 100 day is based on intention-to-treat (ITT)patients .||percentage of partipants|||Number
58015|NCT01230788|Primary|Toxicities of Rituximab|To describe the toxicities of rituximab in addition to prednisone, etoposide, and ifosfamide.|two months after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
57849|NCT01232569|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
57850|NCT01232569|Secondary|Change From Baseline in the Patient’s Pain Visual Analog Score|Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented “no pain” and the extreme right end represented “unbearable pain”. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
57851|NCT01232569|Secondary|Change From Baseline in the Patient’s and the Physician’s Global Assessment of Disease Activity Visual Analog (VAS) Score|Patients and physicians assessed the patient’s disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end represented “maximum disease activity”. Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
57852|NCT01232569|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||mm/hr||Standard Deviation|Mean
57853|NCT01232569|Secondary|Change From Baseline in C-reactive Protein at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||mg/dL||Standard Deviation|Mean
57854|NCT01232569|Secondary|Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24|Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Joint count||Standard Deviation|Mean
57855|NCT01232569|Secondary|Time to Onset of ACR20, ACR50, and ACR70 Responses|Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Days||95% Confidence Interval|Median
57856|NCT01232569|Secondary|Percentage of Patients With ACR50 and ACR70 Responses at Week 24|A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
57857|NCT01232569|Primary|Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
57858|NCT01232504|Secondary|Infection Related Mortality|Infection related mortality after a median follow-up of 600 days.|3～1099 days)|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
57859|NCT01232504|Secondary|Hemorrhage Related Mortality|Hemorrhage related mortality after a median follow-up of 600 days|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
57860|NCT01232504|Secondary|Graft Versus Host Disease (aGVHD) Related Mortality|Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .||percentage of participants|||Number
76591|NCT01036490|Primary|Change in Proteinuria||52 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
57864|NCT01232504|Secondary|Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)|Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).|100 days post transplant|The number of intention-to-treat patients is 206. The incidence of aGVHD analysis is based on intention-to-treat (ITT) patients .||percentage of partipants||95% Confidence Interval|Number
57865|NCT01232504|Secondary|Transplant Related Mortality|Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).|100 days post transplant|The number of intention-to-treat patients is 206. The transplant related mortality analysis within 100 day is based on intention-to-treat (ITT) patients .||percentage of participants||95% Confidence Interval|Number
57866|NCT01232504|Secondary|Hematological Engraftment|The median time of neutrophil and platelet recovery .|100 days post transplant|The number of intention-to-treat patients is 206. The hematological engraftment analysis within 100 day is based on intention-to-treat (ITT)patients .||days||Full Range|Median
57867|NCT01232491|Secondary|Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.||rate per year of patient exposure|||Number
57868|NCT01232491|Secondary|Rate of All Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.||rate per year of patient exposure|||Number
57869|NCT01232491|Secondary|Rate of Treatment Emergent Adverse Events (TEAEs)|Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.||rate per 100 years of patient exposure|||Number
57870|NCT01232491|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
57871|NCT01232491|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
57872|NCT01232491|Secondary|Change From Baseline in Body Mass Index (BMI)|Estimated mean change from baseline in BMI after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||kg/m^2||Standard Error|Least Squares Mean
57873|NCT01232491|Primary|Change From Baseline in Body Weight|Estimated mean change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
57874|NCT01232465|Primary|Pregnancy|detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth|9 months|||participants|||Number
57875|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258|The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile||(ng.h/mL)||Standard Deviation|Mean
57876|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258|Tmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Tmax is the time to to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (time)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile||hours||Full Range|Median
57877|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258|Cmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1).|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile||(ng/mL)||Standard Deviation|Mean
57902|NCT01232127|Secondary|Number of Participants With Abnormalities in Vital Signs|Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate.|Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
58016|NCT01230788|Primary|4 Month Event Free Survival (EFS)|To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one year after enrollment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
57878|NCT01232296|Secondary|Time to Definitive Deterioration in ECOG Performance Status (PS)|Time to definitive deterioration on ECOG PS scale (by at least one point) was defined as the time from the date of randomization to the date of definitive deterioration of the ECOG PS by at least one category of the score from baseline or to the date of death whichever occurred earlier. 0 is Fully active, able to carry on all pre-disease performance without restriction, 1 is Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work and 2 is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first|The Full Analysis Set (FAS): all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. Only Total number of definitive deterioration events included in the analysis||Weeks||95% Confidence Interval|Median
57879|NCT01232296|Secondary|Disease Control Rate (Tumor Assessment)|Disease Control Rate (DCR) is defined as the proportion of patients whose best overall response is either complete response [CR], partial response [PR] or stable disease [SD] according to RECIST 1.1.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.||Participants|||Number
57880|NCT01232296|Secondary|Time to Tumor Progression (Tumor Assessment)|Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). For target lesions, disease progression mean at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression refers to unequivocal progression of existing non-target lesions. In addition, the appearance of new lesions is always considered as disease progression.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.||Weeks||95% Confidence Interval|Median
57881|NCT01232296|Primary|Overall Survival - Overall Survival|The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.||Weeks||95% Confidence Interval|Median
57882|NCT01232283|Secondary|Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 16|Safety population, included all participants who were randomized and received at least one dose of IP. Participants with a PASI ≥ 125% of Baseline score after last dose who did not have psoriasis rebound captured as a Treatment Emergent Adverse Event.||participants|||Number
57883|NCT01232283|Secondary|Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Baseline to Week 16|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)||participants|||Number
57884|NCT01232283|Secondary|Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment with loss of 50% PASI improvement (event), or the time between the re-randomization date and the date of the last PASI assessment in the randomized withdrawal phase prior to addition of topical/phototherapy or other effective psoriasis therapies, or resumption of apremilast 30 mg BID, or discontinuation, or Week 52 if no loss (censored), whichever was earlier|Weeks 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or Apremilast 30mg BID at Week 32.||Weeks||95% Confidence Interval|Median
65861|NCT01151761|Secondary|Liver Transplant Rate|The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm|12 months|||participants|||Number
57885|NCT01232283|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline|"PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome measure #1 for further description.~sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See Outcome Measure #2 for further description."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
57886|NCT01232283|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|"The SF-36 was a 36-item general health instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).~Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
57887|NCT01232283|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16|DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant’s skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from “Very Much” (score 3) to “Not at All” or “Not relevant” (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant’s skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if “No,” then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being “A lot,” “A little,” or “Not at all” (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included||units on a scale||Standard Error|Least Squares Mean
57888|NCT01232283|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
57889|NCT01232283|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||Percentage of Participants|||Number
57890|NCT01232283|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|FAS consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||percent change||Standard Error|Least Squares Mean
76592|NCT01036490|Primary|Change in Proteinuria||12 weeks minus baseline|||mg/g creatinine||Inter-Quartile Range|Median
57891|NCT01232283|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA) at Week 16|"BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint” including the fingers), which equates to approximately 1% of total body surface area.~BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA – baseline BSA) / baseline BSA (%)."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.||percent change||Standard Error|Least Squares Mean
57892|NCT01232283|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator must have factored in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
57893|NCT01232283|Primary|Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. .||percentage of participants|||Number
57894|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|9 months|||participants|||Number
57895|NCT01232205|Secondary|Cell-free mRNA|Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))|40 weeks||||||
57896|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|40 weeks||||||
57897|NCT01232127|Secondary|Number of Participants With Abnormalities in Laboratory Test Results|PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN.|Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
57898|NCT01232127|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett’s and Fridericia’s formulae), and Investigator-identified ECG abnormalities.|Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
57899|NCT01232127|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
57900|NCT01232127|Primary|Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.||Hours||Full Range|Median
57901|NCT01232127|Primary|Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
57912|NCT01231841|Secondary|Comparison of the Level of IS as Assessed by Immuknow Assay in Responders and Non-responders||Every 2 weeks for 3 months beginning on day 1 of therapy and then monthly (for a total of 6 months)||||||
57903|NCT01232127|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.||Participants|||Number
57904|NCT01231984|Secondary|Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hyperglycemic events in his/her diary anytime his/her blood glucose (BG) was above 400mg/dL, or s/he required medical attention for treatment for hyperglycemia.~Hyperglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hyperglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject missed an insulin dose). Subjects were asked to record these events in a diary."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hyperglycemic events.||Adverse Events|||Number
57905|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)|"Subjects’ glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.~Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 12.7 primary analysis due to protocol deviations. The total population size evaluated for this analysis is therefore 113.||HbA1c (%)||Standard Deviation|Mean
57906|NCT01231984|Secondary|Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hypoglycemic events in his/her diary anytime his/her blood glucose (BG) was below 50mg/dL, s/he had signs/symptoms of hypoglycemia, or s/he required medical attention for treatment.~Hypoglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hypoglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously)."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hypoglycemic events.||Adverse Events|||Number
57907|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 12 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a negative pain rating means the period 2 needle was perceived as less painful than the period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 12 mm study arm completed all main study visits. One of the subjects was excluded from all primary and secondary analyses due to protocol deviations.||mm||Standard Error|Mean
57908|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 8 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used in Period 1. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a pain rating < 0 indicates that the Period 2 needle was perceived as less painful than the Period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 8 mm study arm completed all main study visits. Two of the 115 subjects were excluded from all primary and secondary analyses due to protocol deviations. The total number of subjects analyzed for perceived pain for this study was therefore 113.||mm||Standard Error|Mean
57909|NCT01231984|Secondary|Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users|Glycemic control was assessed as by difference between the subjects' HbA1c (%) at baseline (randomization, Visit 3) and at the end of each 12 week study period,in the same manner as for the primary outcome measures. The 95% confidence interval for the mean difference in HbA1c values between the 4mm PN and the longer PN will be estimated based on general linear models adjusting for baseline HbA1c.|Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period.|Of the 226 subjects who were considered for the Primary analysis, 107 subjects had at least one dose of insulin that was at least 40 units. The glycemic control of this sub-group of subjects was analyzed as in the Primary Analysis.The same analysis was performed for the high insulin dose subjects, with the two longer PN study arms pooled together.||HbA1C (%)||Standard Deviation|Mean
57910|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)|"Subjects’ glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.~Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 8 primary analysis due to protocol deviations. The total population size evaluated for the primary objective (4 vs. 8) is therefore 113.||HbA1c (%)||Standard Deviation|Mean
57911|NCT01231841|Secondary|Reduction of VB Repertoire Associated With r-ATG/CsA Combination|We will perform molecular analysis of the TCR repertoire to identify “marker” immunodominant clone specimens using VB typing.|Every 4 weeks||||||
57913|NCT01231841|Primary|Patients Treated With Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) Achieving at Least a Partial Remission (PR) at 6 Months|Patients will be classified as responders if they have transfusion independence and meet two of the following three criteria: ANC greater than 500/mm3; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3. Transfusion independence is defined as no need for transfusions for one month prior to response assessment.|At 6 months|||participants|||Number
57914|NCT01231750|Primary|Severity of Angina Was Measured.|Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.|Application was 45 minutes prior to exercise||||||
57915|NCT01231750|Primary|Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)|Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.|Phase 2 was not done.||||||
57916|NCT01231750|Primary|Maximal Estimated Workload (in METS)|Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
57917|NCT01231750|Primary|Maximal ST Depression|Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
57918|NCT01231750|Primary|Time-to-onset of Angina or Angina Equivalent Symptoms|Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
57919|NCT01231750|Primary|Time-to-onset of 1mm ST Segment Depression|Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
57920|NCT01231750|Primary|Symptom-limited Exercise Duration as an Indicator of Exercise Capacity|Subjects walked on the treadmill as long as they could tolerate, symptom-limited.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.|||||
57921|NCT01231646|Primary|Levels of Folate Receptor Autoantibodies|ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.|On the same day after informed consent was obtained|||ug/mL||Standard Deviation|Mean
57922|NCT01231607|Secondary|Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24|Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15).|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
57923|NCT01231607|Secondary|Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24|"Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: Since the start of treatment, when I look at my thinning area, I can see..., Since the start of treatment, my hair now covers…, and Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is… -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9)."|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
57924|NCT01231607|Secondary|Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||nanomoles per liter (nmol/L)||Standard Deviation|Mean
57925|NCT01231607|Secondary|Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
57926|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 24 (W24). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.||participants|||Number
57964|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
63443|NCT01175850|Secondary|All-cause Death||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of participants|||Number
57927|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12)|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 12 (W12). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.||participants|||Number
57928|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: –3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
57929|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: –3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.||scores on a scale||Standard Error|Least Squares Mean
57930|NCT01231607|Secondary|Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 24 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline with those subsequently obtained at Week 24. This assessment was made separately based on the global photography of the vertex and frontal views.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||scores on a scale||Standard Error|Least Squares Mean
57931|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
57932|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on the hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
57933|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||millimeters||Standard Error|Least Squares Mean
57965|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
76593|NCT01036438|Secondary|Change in Inflammatory Signs|Change in inflammatory signs|4 weeks||||||
57934|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.||millimeters||Standard Error|Least Squares Mean
57935|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.||Hair count||Standard Error|Least Squares Mean
57936|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.||Hair count||Standard Error|Least Squares Mean
57937|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
57938|NCT01231607|Primary|Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.||Hair count||Standard Error|Least Squares Mean
57939|NCT01231581|Secondary|Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The CTCAE version 3.0 displays Grades 1 through 5, with unique clinical descriptions of the severity for each toxicity based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.||participants|||Number
57940|NCT01231581|Secondary|Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 displays Grades 1 through 5 based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.||participants|||Number
58034|NCT01230307|Secondary|Exercise Capacity Measured by 6 Minute Walk Test||6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.|||||
57941|NCT01231581|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Per protocol other events were considered SAEs like symptomatic left ventricular ejection fraction (LVEF) decreases or cases of central serous retinopathy (CSR) or retinal vein occlusion (RVO). AE and SAE data were collected from the start of the first dose of study treatment and continued until 28 days following discontinuation of the study treatment or death. Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.||participants|||Number
57942|NCT01231581|Secondary|Investigator-Assessed Duration of Response|Duration of response is defined, for the subset of participants with a CR or PR, as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).|From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months)|MD Population. Duration of response was assessed for only those participants with a CR or PR.||Weeks||95% Confidence Interval|Median
57943|NCT01231581|Secondary|Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR)|CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). CR and PR were evaluated by the Investigator using standard criteria (RECIST version 1.1). Confirmation of response was not required.|From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|Measurable Disease (MD) Population: all randomized participants regardless of whether or not treatment was administered who had measurable disease at baseline||participants|||Number
57944|NCT01231581|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of radiological PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). PD was also based on unequivocal progression of existing non-target lesions. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, or did not have a documented date of progression or death, PFS was censored at the last adequate assessment.|From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|ITT Population||weeks||95% Confidence Interval|Median
57945|NCT01231581|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who were not dead at the time of analysis; such participants were considered censored.|From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered||months||95% Confidence Interval|Median
57946|NCT01231516|Secondary|DTG PK Parameters Including AUC(0-tau)|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48.|Week 4, Week 24, and Week 48|PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed.||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
57947|NCT01231516|Secondary|DTG PK Parameters Including Cmax, Cmin, C0, and C0_avg|The maximal concentration (Cmax), and the minimal concentration (Cmin) were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 as well as the average C0 (C0_avg) , Cmax and Cmin were estimated and reported here.|Week 4, Week 24, and Week 48|"PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X."||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
66354|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|2 Weeks|Safety Population||percentage of participants|||Number
57948|NCT01231516|Secondary|Number of Participants With the Indicated Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. .|From Baseline until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study|Safety Population: all participants who received at least one dose of IP (i.e., DTG or RAL)||Participants|||Number
57949|NCT01231516|Secondary|Number of Participants With Indicated Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline (Day 1) until Week 48|mITT-E Population||Participants|||Number
57950|NCT01231516|Other Pre-specified|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value data for CD8+ cell count (cells per millimeters cubed [mm^3]) were only reported on a per-participant basis and were not summarized.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|mITT-E Population|||||
57951|NCT01231516|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline (BL), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40 and Week 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|"mITT-E Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each visit is indicated by n=X, X."||cells/mm^3||Inter-Quartile Range|Median
57952|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment."|Week 24, Week 48|mITT-E Population||Participants|||Number
57953|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis."|Week 24|mITT-E Population||Participants|||Number
57954|NCT01231516|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent INI Resistance at Time of Protocol Defined Virology Failure (PDVF)|For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|Baseline until PDVF up to Week 48|mITT-E Population||Participants|||Number
57966|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
59262|NCT01216397|Secondary|Participants Who Discontinued the Trial Because of an Adverse Event|Number of participants who discontinued the trial because of an adverse event|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
57955|NCT01231516|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study."|Week 48|Modified Intent-To-Treat Exposed (mITT-E) Population: all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial.||Percentage of participants|||Number
57956|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57957|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn’t receive any vaccination at this time point|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57958|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57959|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57960|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57961|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57962|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57963|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn’t receive vaccination at this time point.|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
58035|NCT01230307|Primary|Biomarkers|Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).|6 months|Because enrollment was less than 30% of original goal (6 vs 4 subjects) and therefore would not have scientific validity and would be a waste of financial resources, this outcome was not analyzed.|||||
57967|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57968|NCT01231503|Secondary|Concentrations of Antibodies Against Measles Antigens|The seropositivity cut-off for the assay was an anti-measles antibody (Anti-Measles Ab) concentration ≥ 150 milli-international units per millilitre (mIU/mL). Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups.|At Month 10|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||mIU/mL||95% Confidence Interval|Geometric Mean
57969|NCT01231503|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT)|Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (≥) 15 EL.U/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||EL.U/mL||95% Confidence Interval|Geometric Mean
57970|NCT01231503|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers|Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut -off for the assay was ≥ 8. Results will be posted when they become available.|At Month 5||12/2016||||
57971|NCT01231503|Secondary|Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (microg/mL), and tabulated. The seroprotection cut -off for the assay for the purpose of this endpoint was ≥ 0.15 microg/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||microg/mL||95% Confidence Interval|Geometric Mean
57972|NCT01231503|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||IU/mL||95% Confidence Interval|Geometric Mean
57973|NCT01231503|Secondary|Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were than or equal to (≥) 6.2 and 10 mIU/mL, respectively.|At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||mIU/mL||95% Confidence Interval|Geometric Mean
57974|NCT01231503|Secondary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||EL.U/mL||95% Confidence Interval|Geometric Mean
57975|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter|This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4, Missing or Out of range (OOR). Normal WBC level was defined as > 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as < 1.0 Billions WBC/L.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
58001|NCT01231321|Primary|Frequency of Adverse Events|"Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported.~Note:~Severe events considerably interfered in patients' usual activities and may have been life-threatening.~Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness."|Up to 34 weeks (24 week study treatment plus 70-day follow-up period)|All enrolled subjects were included in this intent-to-treat (ITT) analysis.||participants|||Number
57976|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter|This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects’ levels were assessed as either normal, Grade (G) 1, G2, G3, G4, Missing or Out of range (OOR). Normal PLA level was defined as > 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as < 25 Billions PLA/L.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57977|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter|This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects’ levels were assessed as either normal, Grade (G) 1, G2, G3, G4, Missing or Out of range (OOR). Normal HAE level was defined as HAE > 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE < 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE < 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE < 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE < 7.0 g/dL.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57978|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter|This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4, Missing or Out of range (OOR). Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57979|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter|This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4, Missing or Out of range (OOR). Normal ALT level was defined as ALT< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as > 10.0 times the ULN.|At screening (SCR), at Study Day 6 (D6), at 6 days post Study Week 6 (W6+6D), at 6 days post Study Week 10 (W10+6D), at 6 days post Study Week 14 (W14+6D), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
57980|NCT01231503|Secondary|Number of Subjects Reported With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity.|From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.||Subjects|||Number
57981|NCT01231503|Secondary|Number of Subjects Reported With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group.|During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.||Subjects|||Number
58002|NCT01231230|Primary|Maximum Change From Baseline in Airway Blood Flow (Qaw)||maximum change in Qaw within 240 minutes post drug inhalation|||change from baseline ( µl/min/ml)||Standard Error|Mean
58003|NCT01230892|Primary|Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS|Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)|1 year|4 subjects either withdrew or were lost to follow-up and not included in analysis population. Additionally, one subject in the Atenolol arm was removed from analysis population due to IVUS occurring in the incorrect artery and one subject in the Nebivolol arm was removed due to the IVUS catheter malfunctioning.||participants|||Number
57982|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups, M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groups), and M10 for RTS,S 14-26-9M Group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.||EL.U/mL||95% Confidence Interval|Geometric Mean
57983|NCT01231503|Primary|Number of Subjects Reported With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity.|From study start at Month 0 up to Month 10.|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.||Subjects|||Number
57984|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living|The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.||Points on a scale||Standard Error|Least Squares Mean
57985|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy|The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.||Points on a scale||Standard Error|Least Squares Mean
57986|NCT01231464|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)|The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.|Baseline through entire treatment period (Day 1 through Day 14)|Full Analysis Set (FAS): all participants who were randomized and received at least one dose of study medication. Only participants for whom both baseline and post-baseline data were available were included in this analysis.||Points on a scale||Standard Error|Least Squares Mean
57987|NCT01231373|Secondary|Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance|The Independent Photography Review--Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians, evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (0-4, where 0=none and 4=very severe visible varicose veins).|8 weeks|||units on a scale||Standard Error|Least Squares Mean
57988|NCT01231373|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|"The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram fo the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from Not at all noticeable (a score of 0) to Extremely noticeable (a score of 4)."|8 weeks|patients with a baseline and week 8 visit.||units on a scale||Standard Error|Mean
57989|NCT01231373|Primary|Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)|The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.|8 weeks|Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit.||units on a scale||Standard Error|Least Squares Mean
58013|NCT01230788|Secondary|Minimal Residual Disease|To perform serial minimal residual disease (MRD) measurements to provide an objective determination of the effectiveness of this therapy.|one month after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.|||||
57990|NCT01231334|Primary|Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percentage of participants|||Number
57991|NCT01231334|Secondary|Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12|The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percentage of participants|||Number
57992|NCT01231334|Secondary|Percent Change From Baseline in Total Lesion Count at Week 12|Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percent change||Full Range|Median
57993|NCT01231334|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12|"Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percent change||Full Range|Median
57994|NCT01231334|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12|Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percent change||Full Range|Median
57995|NCT01231334|Secondary|Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity|The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Percentage of participants|||Number
57996|NCT01231334|Secondary|Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.||Score on a scale||Standard Deviation|Mean
57997|NCT01231321|Secondary|Change in Disease Activity Score (DAS28) Compared With Baseline|The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease).|Baseline and 24 weeks|All subjects with data available from both Baseline and Week 24 were included in this intent-to-treat (ITT) analysis.||units on a scale||Standard Deviation|Mean
57998|NCT01231321|Primary|Vital Sign Values|"Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory.~Note, in table, BP = blood pressure."|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis.||participants|||Number
57999|NCT01231321|Primary|Deviation From Normal Laboratory Ranges|"Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory.~Note abbreviations used in table:~Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate"|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis. The number of subjects with available data is indicated for each laboratory assessment.||participants|||Number
58000|NCT01231321|Primary|Changes of Physical Examination|Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.|Baseline and 24 weeks|All enrolled subjects with available data were included in this intent-to-treat (ITT) analysis.||participants|||Number
58004|NCT01230827|Secondary|Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48|Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.||Percentage of Participants|||Number
58005|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48|Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.||Percentage of Participants|||Number
58006|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48|Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.||Percentage of Participants|||Number
58007|NCT01230827|Primary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48|Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.||Percentage of Participants|||Number
58008|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel’s Criteria).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV by clinical criteria (Amsel's criteria).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
58009|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for any of three vaginal infections (BV, VVC, Trichomonas vaginalis infection).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
58010|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV as determined by applying standard microscopic scoring criteria (Nugent’s criteria) to vaginal Gram stained slides. BV is diagnosed when the score is greater than or equal to 7.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
58011|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud’s agar.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.||percentage of follow-up visits|Participants|95% Confidence Interval|Number
58012|NCT01230788|Secondary|Prednisone Effect|To correlate the effect of prednisone on CD20 expression using serial measurements of CD20 expression in leukemic blasts.|one month after treatment||||||
59263|NCT01216397|Secondary|Participants With Treatment Emergent Adverse Events|Number of patients with treatment emergent AEs|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
58017|NCT01230749|Secondary|Change From Baseline to Day 29 in Body Weight|Difference is calculated as the change in body weight in Least Square Mean (LSM) from baseline to Day 29 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 29|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||Kilograms||Standard Error|Least Squares Mean
58018|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)|Difference is calculated as the geometric mean change in CRP from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. CRP was not measured for pioglitazone group.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||mg/dL||Standard Deviation|Geometric Mean
58019|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)|Difference is calculated as the geometric mean change in IL-18 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-18 was not measured for pioglitazone group. The unit of IL-18 is picograms per milliliter (pg/mL)|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||pg/mL||Standard Deviation|Geometric Mean
58020|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)|Difference is calculated as the geometric mean change in IL-6 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-6 is a systemic inflammatory markers and is an independent predictors of insulin resistance and progression to type 2 diabetes mellitus. IL-6 was not measured for pioglitazone guoup. The unit of IL-6 is picograms per milliliter (pg/mL).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||pg/mL||Standard Deviation|Geometric Mean
58021|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Resistance|Difference is calculated as the change in insulin resistance in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insuline sensitivity is measured by absolute change in Homeostasis Model Assessment of insulin resistance (HOMA-IR). Insulin sensitivity is HOMA-%S and HOMA-IR is the reciprocal of HOMA-%S. HOMA-IR calculated as: (Glucose [mg/dL]) multiplied by Insulin [pmol/L]) divided by (405 multiplied by 6.945). Lower value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-IR was not collected on Day 28.||HOMA-IR score||Standard Error|Least Squares Mean
58022|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Secretion|Difference is calculated as the change in insulin secretion in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insulin secretion is measured by the absolute change in Homeostasis Model Assessment of steady state islet beta cell (HOMA-%B). HOMA-%B calculated as: (360 multiplied by Insulin [pmol/L]) divided by ([Glucose {mg/dL} minus 63] multiplied by 6.945). Higher value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-%B was not collected on Day 28.||HOMA-B score||Standard Error|Least Squares Mean
58023|NCT01230749|Secondary|Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)|Difference is calculated as the change in FPG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for FPG was not collected on Day 28.||mg/dL||Standard Error|Least Squares Mean
58024|NCT01230749|Primary|Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)|Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.|From baseline (Day -1) to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.||mg/dL||Standard Error|Least Squares Mean
58036|NCT01230060|Primary|Visual Acuity|Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.|120-180 days (visit 4)|All non missing implanted eyes, consistent set||Participants|||Number
58037|NCT01230021|Secondary|Physical Examination (Evaluated as Normal/Abnormal)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||participants|||Number
58038|NCT01230021|Secondary|Vital Signs - Blood Pressure (Systolic and Diastolic)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||mmHg||Standard Deviation|Mean
58025|NCT01230710|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.||Percentage of participants|||Number
58026|NCT01230710|Secondary|Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)|A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.||Percentage of participants|||Number
58027|NCT01230710|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrolment to the date of death from any cause.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.||Days||Inter-Quartile Range|Median
58028|NCT01230710|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.||Days||95% Confidence Interval|Median
58029|NCT01230710|Primary|Percentage of Participants With Progression-free Survival at Week 52|A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).|Full analysis set: All enrolled participants.||Percentage of participants|||Number
58030|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.~Reference intervals include:~Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|12 months post enrollment/randomization|||mL/min/1.73 sqm||Standard Deviation|Mean
58031|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.~Reference intervals include:~Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|6 months post enrollment/randomization|||mL/min/1.73 sqm||Standard Deviation|Mean
58032|NCT01230307|Secondary|Vitamin D Genomics|Genotyped for the restricted fragment length polymorphism at the BsmI site. In addition CYP2R1, CYP27B1, CYP24 will also be genotyped.|Baseline|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity, in addition there is significant time and costs associated with this measurement which would result in data that would lead to no conclusions, this outcome was not analyzed.|||||
58033|NCT01230307|Secondary|Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire|Kansas City Cardiomyopathy Questionnaire for quality of life is measured on a scale of 0 - 100, with 100 being best.|6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.|||||
58040|NCT01230021|Secondary|Clot Solubility Test (Evaluated as Normal/Abnormal)|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||participants|||Number
58041|NCT01230021|Secondary|Coagulation Related Parameters - Prothrombin Time (PT) (Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||Sec||Standard Deviation|Mean
58042|NCT01230021|Secondary|Coagulation Related Parameters - Activated Partial Thromboplastin Time (aPTT, Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||Sec||Standard Deviation|Mean
58043|NCT01230021|Secondary|Coagulation Related Parameters - Fibrinogen||Day 0 and at day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||g/L||Standard Deviation|Mean
58044|NCT01230021|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors (Neutralising Antibodies Against Factor XIII)||At screening and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||percentage of subjects|||Number
58045|NCT01230021|Secondary|Percentage of Subjects With One or More Serious Adverse Events (SAEs)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||percentage of subjects|||Number
58046|NCT01230021|Secondary|Percentage of Subjects With One or More Adverse Events (AEs) Recorded||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||percentage (%) of subjects|||Number
58047|NCT01230021|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state (Vss) is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Steady state is achieved when all variables are constant in spite of ongoing processes.|At steady state|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||mL/kg||Standard Deviation|Mean
58048|NCT01230021|Secondary|Total Plasma Clearance (CL)|The total plasma clearance is a measure of the elimination of a drug from the body. Drugs are excreted primarily by the kidneys into the urine. Clearance is calculated as ‘CL=Dose / AUC0-30 days’).|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||mL/h/kg||Standard Deviation|Mean
58049|NCT01230021|Secondary|Mean Residence Time (MRT)|The mean residence time (MRT) of a drug in the body and related functions are derived for drugs which are intravenously administered.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||hours||Standard Deviation|Mean
58050|NCT01230021|Secondary|Terminal Half-life (t½)|Time point when half of the maximum plasma concentration is reached.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||hours||Full Range|Mean
58051|NCT01230021|Secondary|Maximum Plasma Concentration (Cmax) for FXIII|Maximum plasma concentration of the drug reached.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||U/mL||Standard Deviation|Mean
58052|NCT01230021|Secondary|Area Under the Concentration vs. Time Curve (AUC0-∞)|A measure of exposure.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||IU*h/mL||Standard Deviation|Mean
58053|NCT01230021|Primary|Area Under the Concentration vs. Time Curve (AUC)|A measure of the exposure. Blood samples for the PK assessment were drawn pre-dose and up to 30 days after dosing. The PK of FXIII in children was assessed after a single i.v. dose of rFXIII 35 IU/kg.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.||IU*h/mL||Standard Deviation|Mean
58054|NCT01229943|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|From registration to time of death, assessed up to 3 years|||months||95% Confidence Interval|Median
58055|NCT01229943|Secondary|Overall Response Rate|The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Up to 3 years|||percentage of participants|||Number
58056|NCT01229943|Primary|Progression Free Survival|Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.|From study entry to the date of documented progression or death from any cause, up to 3 years|||months||95% Confidence Interval|Median
58057|NCT01229891|Secondary|Serum High Density Lipoprotein (HDL)||12-week|||mg/dL||Standard Deviation|Mean
58058|NCT01229891|Secondary|Serum Low Density Lipoprotein (LDL)||12-week|||mg/dL||Standard Deviation|Mean
58059|NCT01229891|Secondary|Serum Total Cholesterol (Tchol)||12-week|||mg/dL||Standard Deviation|Mean
58060|NCT01229891|Secondary|Serum Triglyceride (TG)||12-week|||mg/dL||Standard Deviation|Mean
58061|NCT01229891|Secondary|Hemoglobin A1c (HbA1c)||12-week|||percent||Standard Deviation|Mean
58062|NCT01229891|Secondary|Insulin|fasting serum insulin concentration|12-week|||mU/L||Standard Deviation|Mean
58065|NCT01229735|Secondary|Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52||From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the SS who returned at least 1 postbaseline seizure diary.||responders|||Number
58066|NCT01229735|Secondary|Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52|Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.|From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the Safety Set (SS) who returned at least 1 postbaseline seizure diary.||percent reduction||Inter-Quartile Range|Median
58067|NCT01229735|Secondary|Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.||month||Inter-Quartile Range|Median
58068|NCT01229735|Secondary|Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.||Participants|||Number
58069|NCT01229735|Primary|Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate||From Baseline to Week 52|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.||percentage of subjects|||Number
58070|NCT01229722|Primary|Pill Count|During the clinic visits ever 3 weeks over the course of the study, participants will be asked to bring all their pill bottles and count the contents of each bottle with assistance from the study coordinator. This count will be compared with the refill history for that patient from the pharmacy in order to get a sense of how many pills they have taken.|every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012||||||
58071|NCT01229722|Primary|Self-Report|During the clinic visits ever 3 weeks over the course of the study, participants will be asked to recall what pills they took and what they missed.|every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012||||||
58072|NCT01229722|Primary|Adherence to Anti-retroviral Therapy|MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.|daily, for the 6 month duration of the third user study, from October 2011 through March 2012|||percentage adherence||Standard Deviation|Mean
58073|NCT01229527|Secondary|Patient's Satisfaction|The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.|After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone|||units on a scale||Standard Deviation|Mean
58074|NCT01229527|Primary|Discharge Time, the Time to Reach a Modified Aldrete Score ≥18|Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.|> 0 minutes|||minutes||Inter-Quartile Range|Median
58075|NCT01229462|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4|Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 4|Intent-to-treat population consisted of all randomized participants.||mm Hg||Standard Deviation|Mean
58076|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 180 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58077|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 90 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 90 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58100|NCT01229436|Other Pre-specified|Number of Participants With Anti-Drug Antibody (ADA)|Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).|Screening, Follow-up Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
58078|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after fourth injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58079|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58080|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58081|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58082|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58083|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58084|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58116|NCT01229423|Primary|Change From Baseline in Eyelash Length at Week 20|Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Millimeter (mm)||Standard Deviation|Mean
66426|NCT01145755|Secondary|MADRS Response|A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.|6 weeks|||Participants|||Number
58085|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58086|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58087|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58088|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58089|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58090|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58091|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58117|NCT01229410|Secondary|Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)|Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood.|60 Days|Per Protocol: all subjects with qualified pharmacokinetic samples||Percentage of Patient Samples|Participants||Number
58980|NCT01219881|Secondary|Severity of Coughing|Effect of desflurane versus sevoflurane on the incidence and severity of coughing using a standardized coughing scale|14 days|Determined if patient passed eligibility and completed study.||Patients with a coughing episode|||Number
58092|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. ‘N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58093|NCT01229436|Secondary|Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. ‘Number of participants’ analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event.||days||Full Range|Median
58094|NCT01229436|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event.||events||Full Range|Median
58095|NCT01229436|Secondary|Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
58096|NCT01229436|Secondary|Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score|URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to >=5 items, then average score of answered questions was imputed response to missing questions.|Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||units on a scale||Full Range|Median
58097|NCT01229436|Secondary|Time to Recovery|Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.|Up to Day 30 after first, second and third injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||days||95% Confidence Interval|Median
58098|NCT01229436|Secondary|Number of Days Assessed on Dupuytren’s Treatment Assessment Daily Diary Questionnaire|Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).|C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.||days||Full Range|Median
58099|NCT01229436|Secondary|Number of Days of Concomitant Pain Medication Usage|Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure.||days||Full Range|Median
58101|NCT01229436|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy[if urine tested positive for blood or protein]).|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.||participants|||Number
58102|NCT01229436|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.||participants|||Number
58103|NCT01229436|Secondary|Number of Participants With Type of Concomitant Pain Medication Used|Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.||participants|||Number
58104|NCT01229436|Secondary|Physician Global Assessment of Treatment Satisfaction and Disease Severity|Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician’s rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.|Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
58105|NCT01229436|Secondary|Participant Global Assessment of Treatment Satisfaction and Disease Severity|Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.|Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.||participants|||Number
58106|NCT01229436|Secondary|Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58107|NCT01229436|Secondary|Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58108|NCT01229436|Secondary|Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection|TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection|FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.||degrees|Participants|Full Range|Median
58109|NCT01229436|Secondary|Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58110|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for First Injection|TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first injection|Full analysis set(FAS):participants who received at least (>=)1 injection of Xiapex,had >=1 post-injection efficacy assessment(goniometric/participant-reported). 'N’(number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.||degrees|Participants|Full Range|Median
58111|NCT01229423|Secondary|Percentage of Subjects Satisfied With Treatment at Week 20|Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question “Which best describes your satisfaction with LATISSE®?” Responses were “very satisfied”, “satisfied”, “neutral”, “unsatisfied”, and “very unsatisfied.” Satisfied is defined as responses of “very satisfied” and “satisfied.”|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Percentage of Subjects|||Number
58112|NCT01229423|Secondary|Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20|Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question “Overall how satisfied are you with your eyelashes?” Responses were based on a 5-point scale (“very unsatisfied”, “unsatisfied”, “neutral”, “satisfied”, “very satisfied”). Improvement in subject satisfaction is defined as a 1-point increase from baseline.|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Percentage of Subjects|||Number
58113|NCT01229423|Secondary|Change From Baseline in Eyelash Intensity (Darkness) at Week 20|Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Units on a Scale||Standard Deviation|Mean
58114|NCT01229423|Secondary|Change From Baseline in Eyelash Thickness at Week 20|Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Millimeters Squared (mm^2)||Standard Deviation|Mean
58115|NCT01229423|Secondary|Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20|Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.||Percentage of Subjects|||Number
58118|NCT01229410|Secondary|Highest Aqueous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.|60 Days|Per Protocol: all subjects with pharmacokinetic data available||Nanogram/milliliter (ng/mL)|||Number
58119|NCT01229410|Primary|Highest Vitreous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.|60 Days|Per Protocol: all subjects with pharmacokinetic data available||Nanogram/milliliter (ng/mL)|||Number
58120|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers||Fold (ratio)||95% Confidence Interval|Number
58121|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroconversion rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
58122|NCT01229397|Secondary|Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability||Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary|Safety population, all vaccinated subjects||participants|||Number
58123|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroprotection rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
58124|NCT01229371|Primary|Immunogenicity - Seroconversion Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
58125|NCT01229371|Primary|Immunogenicity - Seroprotection Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||percentage subjects||95% Confidence Interval|Number
58126|NCT01229371|Secondary|Number of Participants With Local and Systemic Adverse Events|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects||participants|||Number
58127|NCT01229371|Primary|Immunogenicity - Geometric Mean Titer Fold Increase From Baseline|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers||GMT fold increase||95% Confidence Interval|Number
58128|NCT01229228|Primary|Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0|"Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|Over 0 to 12 Hours|||units on a scale||95% Confidence Interval|Least Squares Mean
58129|NCT01229176|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|"Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.~Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.~Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants)."|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population.||participants|||Number
58130|NCT01229176|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
58131|NCT01229176|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set||ELISA Units/mL||95% Confidence Interval|Geometric Mean
58132|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set||percentage of subjects||95% Confidence Interval|Number
58133|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.||percentage of subjects||95% Confidence Interval|Number
58134|NCT01229150|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|42 months|The combination of toxicities allows for a more robust understanding of the combined therapy toxicities. The dosage of the combination of erlotinib plus AZD6244 was the same whether the pt has a KRAS mutation versus KRAS wild type. KRAS is a molecular mutation and does not change whether or not a pt has toxicities to the combination of therapies.||Participants|||Number
58135|NCT01229150|Primary|Progression Free Survival|Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that's the smallest on study). In addition to the relative increase of 20% of at least 5mm. (Note: the appearance of one or more lesions is also considered progression).|2.1 to 4 months|||Months||95% Confidence Interval|Median
58136|NCT01228968|Secondary|Subcutaneous Fat Volume With Manual Segmentation|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with the older manual segmentation technique.|five minutes|||cubic centimeters||Standard Deviation|Mean
58137|NCT01228968|Primary|Visceral Fat Volume With Manual Segmentation|This is the measure of visceral fat found with our older manual segmentation method|five minutes|||cm3||Standard Deviation|Mean
58138|NCT01228968|Primary|Visceral Fat Volume With Automated Analysis|This is the measurement of Abdominal Visceral Fat in cubic centimeters as determined with a new automated segmentation program.|five minutes|||cubic centimeters||Standard Deviation|Mean
58139|NCT01228968|Secondary|Subcutaneous Fat Volume With Automated Analysis|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with new automated anatomical segmentation software.|five minutes|||cubic centimeters||Standard Deviation|Mean
58140|NCT01228929|Primary|Change in Ocular Surface Temperature (OST)|Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group.|baseline and 30 minutes|||degree celsius|Participants|Standard Deviation|Mean
58141|NCT01228747|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.|Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.||participants|||Number
58142|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.||participants|||Number
58143|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.||participants|||Number
58144|NCT01228747|Secondary|The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline."|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure in Evaluation Period.||Percentage Change||Standard Deviation|Mean
58145|NCT01228747|Primary|Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.||Percentage Change||Standard Deviation|Mean
58146|NCT01228591|Secondary|Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)|Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|Baseline|Subjects analyzed included only those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
58147|NCT01228591|Secondary|Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)|Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.|Baseline|Analysis was on those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
58148|NCT01228591|Secondary|Subject Reported Vision Using Contact Lens User Experience (CLUE).|Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
58149|NCT01228591|Secondary|Contact Lens Comfort Using Contact Lens User Experience (CLUE)|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.||CLUE points||Standard Error|Least Squares Mean
58150|NCT01228591|Primary|Visual Acuity at Time of Initial Fit|Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.|After 10-15 minutes of lens wear|Analysis is conducted on those were enrolled and completed the trial.||LogMAR|Participants|Standard Deviation|Mean
58151|NCT01228591|Primary|Visual Acuity One Week After Lens Wear|Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.|1 week|Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.||LogMAR|Participants|Standard Error|Least Squares Mean
58152|NCT01228435|Secondary|Safety|Further document the safety of this regimen. Treatment-emergent adverse events will be summarized by MedDEA coding terms and seperate tabulations will be produced for treatment-related adverse events, treatment-emergent serious adverse events, discontinuations due to adverse events, and treatment-emergent events of at least Grade 3 severity.|2 years||||||
58153|NCT01228435|Primary|Response Rate|The response rate was defined as the number of patients achieving a RECIST 1.0 defined response divided by the number of patients treated and was to be calculated seperately for each arm. A response by RECIST criteria means that the pre-defined target lesions (sum of the longest diameters) had to decrease by 30% or more and this response needed to be confirmed on a second scan at least 4 weeks later.|2 years|||participants|||Number
58154|NCT01228175|Primary|Cigarettes Per Smoking Day||up to 36 weeks|||Cigarettes smoked||Standard Deviation|Mean
58155|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype||Day 1 of study treatment|||hours||Full Range|Median
58156|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype||Day 1 of study treatment|||Hours||Full Range|Median
58157|NCT01228084|Secondary|Half-life of Sulforaphane (SFN) in Blood||Day 1 of study treatment|||hours||Full Range|Median
58158|NCT01228084|Secondary|Incidence of Grade 3 or Higher Treatment Related Toxicity|Toxicities will be graded based on the NIH Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria of Adverse Events Version 4.0 (http://ctep.cancer.gov). All adverse events of any grade (for example, abnormal laboratory values, etc.) deemed clinically significant by the investigator will be recorded as a measure of the safety profile of sulforaphane|Continually through study and 14-30 days after last drug dose.|||participants|||Number
58159|NCT01228084|Secondary|Proportion of Patients Whose PSA Levels Have Not Doubled||While on treatment with sulforaphane (less than or equal to 20 weeks.)|||percentage of participants|||Number
58160|NCT01228084|Secondary|Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA)||PSA measured every 28 days while on study treatment, an average of 5 months|||percent change||Full Range|Median
58161|NCT01228084|Secondary|Percent Change in PSA From Baseline to Final Measured Value at End of Study|To determine the percentage change in PSA from baseline to the final measured value at the end of study.|Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)|||Percent change||Full Range|Median
58162|NCT01228084|Primary|Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels|To determine the proportion of patients who achieve a decline in PSA levels while receiving sulforaphane treatment. as a measure of anti-tumor activity in men with recurrent prostate cancer.|Less than or equal to 20 weeks of sulforaphane treatment.|||percentage of participants|||Number
58163|NCT01228071|Primary|Gel Drying Time|Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3”× 5” postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.|1 day; drying time measured following gel application on Day 14|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.||minutes||95% Confidence Interval|Median
58164|NCT01228071|Primary|Time to Steady State (SS)|Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.|14 days|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.||days||95% Confidence Interval|Median
58165|NCT01228071|Primary|Time to Target Eugonadal Range|The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.|24 hours|Of the 31 subjects in the PK population, 7 subjects were not included in the analysis for time to eugonadal range. Five (5) subjects had total testosterone serum concentrations of ≥300 ng/dL at Visit 2 (baseline, time 0) and 2 subjects had total testosterone serum concentrations that never reached 300 ng/dL.||hours||95% Confidence Interval|Median
58166|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 24|The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of “Improved”, “Unchanged” or “Worsened” when compared to baseline.|Baseline and Week 24|Participants in safety population whose case report form contained the investigator's overall assessment after 24 weeks of treatment with TREDAPTIVE||Percentage of Participants|||Number
58167|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 12|The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of “Improved”, “Unchanged” or “Worsened” when compared to baseline.|Baseline and Week 12|Participants in safety population whose case report form contained the investigator's overall assessment after 12 weeks of treatment with TREDAPTIVE||Percentage of Participants|||Number
58168|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 24|Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for triglyceride levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
58169|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24|Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for HDL-C levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
58170|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24|Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for LDL-C levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
58171|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 24|Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for total cholesterol levels and had received TREDAPTIVE for 24 weeks||mg/dL||Standard Deviation|Mean
58172|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 12|Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for triglyceride levels.||mg/dL||Standard Deviation|Mean
58173|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for HDL-C levels.||mg/dL||Standard Deviation|Mean
58174|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels.||mg/dL||Standard Deviation|Mean
58175|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 12|Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels.||mg/dL||Standard Deviation|Mean
58176|NCT01228019|Primary|Percentage of Participants With Adverse Drug Reactions|An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data||Percentage of Participants|||Number
58177|NCT01228019|Primary|Percentage of Participants With Any Adverse Experience|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data||Percentage of participants|||Number
58178|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
58179|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
58180|NCT01227993|Secondary|Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
58181|NCT01227993|Secondary|Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years||||||
58187|NCT01227993|Secondary|Change in Serum DHT Levels at Two Years Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in picograms of DHT per milliliter of serum.|Baseline and 2 years|||pg/mL||Standard Deviation|Mean
58188|NCT01227993|Secondary|Change in Serum Testosterone Levels at Two Years Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in nanograms of testosterone per decaliter of serum.|Baseline and 2 years|||ng/dL||Standard Deviation|Mean
58189|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year|||ETDRS letters|Participants|Standard Deviation|Mean
58190|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year|||ETDRS letters|Participants|Standard Deviation|Mean
58191|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years|||ETDRS letters|Participants|Standard Deviation|Mean
58192|NCT01227993|Primary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years|||ETDRS letters|Participants|Standard Deviation|Mean
58193|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Mean
58194|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58195|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58196|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58197|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58198|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58199|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58293|NCT01227785|Primary|Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|73 CRT-D and 44 ICD patients had data available at pre-discharge visit.||milli volt (mV)||Standard Deviation|Mean
58200|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58201|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58202|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58203|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58204|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58205|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58206|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Mean
58207|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
58208|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Mean
58209|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. The cut off for these data was October 12, 2012.||participants|||Number
58294|NCT01227785|Primary|Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients|implant|74 CRT-D and 45 ICD patients had data available at implant||milli volt (mV)||Standard Deviation|Mean
58295|NCT01227785|Primary|Clinical Performance at1-month for RA Sensing Amplitude|RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1-month|53 CRT-D and 11 ICD patients had data available at 1-month visit.||milli volt (mV)||Standard Deviation|Mean
77558|NCT01026805|Secondary|Resected Tissue Weight Per Patient|mean weight of resected tissue per patient|at time of treatment|||g||Full Range|Mean
58210|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.||participants|||Number
58211|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.||participants|||Number
58212|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)|12-lead ECGs were obtained at the scheduled visits. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period. The QTc is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the faster the heart rate the shorter the QTc. If a QTc >=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality. The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Only those participants for which a post-Baseline ECG was conducted were analyzed. The cut off for these data was October 12, 2012.||participants|||Number
58213|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline|Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg). A participant could have been counted in more than one shift category. Participants who experienced shifts in both SBP and DBP are represented under each individual parameter. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. One participant on placebo did not report any blood pressure measurements post-Baseline. The cut off for these data was January 10, 2014.||participants|||Number
58214|NCT01227928|Secondary|Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE|An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
58215|NCT01227928|Secondary|Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
58232|NCT01227902|Secondary|Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal|The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
58216|NCT01227928|Secondary|Number of Participants With the Indicated On-therapy Grade 3-5 AEs|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
58217|NCT01227928|Secondary|Number of Participants With Any Grade 3 or 4 AE|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
58218|NCT01227928|Secondary|Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
58219|NCT01227928|Secondary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.||participants|||Number
58220|NCT01227928|Secondary|Number of Participants With Any Dose Reduction or Any Dose Interruption|Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.||participants|||Number
58221|NCT01227928|Secondary|PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria|"PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as Progressed per RECIST if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as Progressed per CA-125 if the radiological PD occurred after CA-125 progression. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment."|From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)|ITT Population. The cut off for these data was October 12, 2012.||months||95% Confidence Interval|Median
58222|NCT01227928|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.|From randomization until death due to any cause (average of 29.4 months)|ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014.||months||95% Confidence Interval|Median
58223|NCT01227928|Primary|Progression-free Survival (PFS)|PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants’ dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.|From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)|Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012.||months||95% Confidence Interval|Median
58224|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
58225|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
58226|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
58227|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
58228|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Epilepsy-related Worry|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
58229|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
58230|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The mental component summary (MCS) score is a summary score representing overall mental health, which is derived from the 8 domains. As with the domains, MCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
58231|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The physical component summary (PCS) score is a summary score representing overall physical health, which is derived from the 8 domains. As with the domains, PCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Scores on a scale||Standard Deviation|Mean
58280|NCT01227785|Primary|Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported at 1-month post-implant|1-month|73 CRT-D patients had data available at 1-month visit||Ohms||Standard Deviation|Mean
58233|NCT01227902|Secondary|Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time|"Participants were asked the following question daily: Did you miss any time from work or school in the last 24 hours due to epilepsy? Possible responses were Yes, No, and NA=Not Applicable (no planned work or school in the last 24 hours). The variable summarized is the percentage of days with no missed work or school. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A positive percent change from Baseline indicates a reduction from Baseline in missed work or school."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
58234|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you wanted to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I wanted to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
58235|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you needed to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I needed to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
58236|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry|"Participants were asked the following question daily: How would you rate your epilepsy-related worry over the last 24 hours? The original possible responses were 0-10, with 0=No worry and 10=Worst worry imaginable. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Percent change||Standard Deviation|Mean
58237|NCT01227902|Secondary|Percent Change From Baseline in Partial-onset Seizure Frequency|Percent change from Baseline was calculated as the difference in the partial-onset seizure frequency (Treatment Phase minus the Baseline Phase) divided by the Baseline Phase frequency, multiplied by 100. Negative values indicate reductions from Baseline. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population||percent change||Standard Deviation|Mean
58238|NCT01227902|Secondary|Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline|The number of participants experiencing a >=25%, >=75%, and 100% reduction from Baseline in partial-onset seizure frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population||participants|||Number
58239|NCT01227902|Secondary|Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency|Participants were assessed for the percent change from Baseline in seizure frequency; changes were categorized as Any Decrease (>0 to 25%, 25 to <50%, 50 to 75%, >75 to 100%) or No Change or Any Increase (>25%, 0 to 25%). A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population||participants|||Number
58281|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported for pre-discharge visit|pre-discharge|75 CRT-D patients had data available at pre-discharge||Ohms||Standard Deviation|Mean
58282|NCT01227785|Primary|Clinical Performance at Implant LV Pacing Impedance for CRT-D.|LV pacing impedance results at implant were measured in CRT-D.|implant|78 CRT-D patients had data available at implant||Ohms||Standard Deviation|Mean
58283|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Threshold|RA pacing threshold results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month visit||volts (V)||Standard Deviation|Mean
87332|NCT00934843|Secondary|Urine Output|Total urine output in mL over the first 36 hours after cardiac surgery|over 36 hours|||mL||Standard Deviation|Mean
58240|NCT01227902|Primary|Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline|The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase.|From Baseline through Week 20 (Day 140)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants in the Safety Population (all participants who took at least one dose of investigational product) who provided at least one post-Baseline efficacy assessment||participants|||Number
58241|NCT01227889|Secondary|Validation of the BRAF Mutation Assay|Analytical and clinical validation of the companion diagnostic (cDx) assay was performed to determine the extent of agreement between the bioMerieux cDx assay (THxID BRAF Assay) and the Response Genetic Incorporated Investigational Use Only assay used to detect BRAF mutations to determine participant eligibility into the study. Skin tissue samples collected at the Screening visit were used for this analysis. However, assay validation is ongoing; no data are available at this time.|Screening||||||
58242|NCT01227889|Secondary|Number of Participants With Non-melanoma Skin Lesions: Randomized Phase|Dermatological examinations were performed by the investigator, or at the discretion of the investigator, referred to a dermatologist. The number of participants with non-melanoma skin lessions was assessed from the time of Screening until study completion or discontinuation from the study for any reason.|From Screening until study completion or discontinuation from the study (up to 9.9 months)|Safety Population: all randomized participants who received at least one dose of study drug, based on the actual treatment received, if this differed from that to which the participant was randomized||participants|||Number
58243|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Crossover Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 6.4 months)|Crossover Population. Only participants with a confirmed CR or PR were assessed for duration of response.||Months||95% Confidence Interval|Median
58244|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Crossover Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (up to 6.4 months)|Crossover Treatment Population. At the time data were analyzed for overall response, only 35 participants had crossed over from DTIC treatment to GSK25118436 treatment.||participants|||Number
58245|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by an Independent Radiologist|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|ITT Population||Months||95% Confidence Interval|Median
58246|NCT01227889|Secondary|Progression-free Survival (PFS2) as Assessed by the Investigator: Crossover Phase|PFS2 is defined as the time from the first dose of GSK2118436, in participants randomized to DTIC who crossed over to GSK2118436 after initial progression, to the earliest date of radiographic or photographic disease progression or death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time from first dose of GSK2118436 in participants who crossover after initial progression to the earliest date of radiographical or photographical PD or death due to any cause (up to 6.4 months)|Crossover Treatment Population: the subset of participants who were randomized to the DTIC arm, and who elected at the point of disease progression to receive GSK2118436. Only participants who received at least one dose of GSK2118436 were included in the Crossover Treatment Population.||Months||95% Confidence Interval|Median
58247|NCT01227889|Secondary|Duration of Response as Assessed by an Independent Radiologist: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 7.4 months)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.||Months||95% Confidence Interval|Median
58248|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 65.6 weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.||Months||95% Confidence Interval|Median
58249|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed CR or PR as Assessed by an Independent Radiologist: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an independent radiologist per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 12.0 weeks)|ITT Population||participants|||Number
58250|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 6.6 weeks)|ITT Population||participants|||Number
58251|NCT01227889|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)|ITT Population||Months||95% Confidence Interval|Median
58252|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered||Months||95% Confidence Interval|Median
58253|NCT01227824|Secondary|Cmax and Ctau of DTG|The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.|Week 4, Week 24, and Week 48|The Pharmacokinetic (PK) Concentration Population: all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
58284|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Threshold|RA pacing threshold results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge||volts (V)||Standard Deviation|Mean
58285|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Threshold|RA pacing threshold results were reported for implant|implant|56 CRT-D and 11 ICD patients had data available at implant||volts (V)||Standard Deviation|Mean
58254|NCT01227824|Secondary|AUC(0-tau) of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. AUC was estimated using population PK modeling based on PK data from all visits.|Week 4, Week 24, and Week 48|The Pharmacokinetic (PK) Concentration Population: all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.||Micrograms*hour per milliliter(µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
58255|NCT01227824|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death.|From Baseline until Week 96|Safety Population: all participants who received at least one dose of investigational product||Participants|||Number
58256|NCT01227824|Secondary|Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline until Week 96|ITT-E Population||Participants|||Number
58257|NCT01227824|Secondary|Absolute Values in CD4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy.bsolute values in CD4+ cell counts over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
58258|NCT01227824|Secondary|Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
58259|NCT01227824|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Absolute values in plasma HIV-1 RNA over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||log10 c/mL||Standard Deviation|Mean
58260|NCT01227824|Secondary|Change From Baseline in Plasma HIV-1 RNA Over Time|Change from baseline in plasma HIV-1 RNA over time was assessed at Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96. Change from baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time points were assessed.||log10 c/mL||Standard Deviation|Mean
58261|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.|Week 48 and Week 96|ITT-E Population||Participants|||Number
58262|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.|Week 96|ITT-E Population||Participants|||Number
58263|NCT01227824|Secondary|Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.|Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.|Week 48 and Week 96|ITT-E Population||Participants|||Number
58286|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Threshold|RV pacing threshold results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit.||volts (V)||Standard Deviation|Mean
58287|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Threshold|RV pacing threshold results were reported at pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge||volts (V)||Standard Deviation|Mean
58264|NCT01227824|Primary|Percentage of Participants With HIV-1RNA <50 Copies (c)/Milliliter (mL) Through Week 48.|Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) “snapshot” algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment.|Baseline to Week 48|Intent-to-Treat Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
58265|NCT01227785|Primary|Wanded Telemetry Issues at Pre-discharge Follow-up|The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.|Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit|118 was the total number of questionnaires completed and available from the PI for analysis.||issues|||Number
58266|NCT01227785|Primary|Spontaneous Episode Conversion Success Rate at 3 Months|Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.|3-month|Of the 13 CRT-D and 8 ICD patients that experienced a spontaneous episode, the successful conversions were reported.||percentage of successful conversions|Participants||Number
58267|NCT01227785|Primary|Induced Episode Detection Times at 3 Months|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|3-month|Of the 6 CRT-D and 3 ICD patients with available data that had succesful conversion after induced VT/VF episodes, the mean time was determined at 3 months||seconds||Standard Deviation|Mean
58268|NCT01227785|Primary|Induced Episode Detection Times at 1-month|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|1-month|Of the 1 CRT-D and 1 ICD patients that underwent induced VT/VF at 1month, the mean time for successful conversion was reported.||seconds||Standard Deviation|Mean
58269|NCT01227785|Primary|Induced Episode Detection Times at Implant|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|implant|Of the 30 CRT-D and 22 ICD patients with induced VT/VF episodes, the mean time required for conversion was reported for all available data||seconds||Standard Deviation|Mean
58270|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 3-months|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|3-month|Of the 6 CRTD and 3 ICD patients that had induced VT/VF episodes at 3-month follow-up, the number of those that were converted successfully was reported in %||percentage of successful conversions|||Number
58271|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 1-month|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|1-month|Of all patients that experienced an induced VT/VF episode at 1-month, the number that had successful conversions was reported for both CRT-D and ICD patients.||percentage of successful conversions|||Number
58272|NCT01227785|Primary|Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|implant|Of the 30 CRT-D and 22 ICD patients with induced episodes, the number with successful conversions was determined. The % of patients that had successful conversion was then reported.||percentage of successful conversions|||Number
58273|NCT01227785|Primary|Product Experiences Reported by the Site for All Patients for Study Duration|Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.|Overall study results|All patients from overall study population were considered. Of the total population, the number of product experiences was reported.||experiences|||Number
58274|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Impedance|RA pacing impedance results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month||Ohms||Standard Deviation|Mean
58275|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Impedance|RA pacing impedance results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge||Ohms||Standard Deviation|Mean
58276|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Impedance|RA pacing impedance results were reported at implant|implant|56 CRT-D and 11 ICD patients had data available at implant||Ohms||Standard Deviation|Mean
58277|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Impedance|RV pacing impedance results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit||Ohms||Standard Deviation|Mean
58278|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Impedance|RV pacing impedance results were reported for pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge||Ohms||Standard Deviation|Mean
58279|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Impedance|RV pacing impedance results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant||Ohms||Standard Deviation|Mean
58296|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Sensing Amplitude|RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|55 CRT-D and 11 ICD patients had data available at pre-discharge visit.||milli volt (mV)||Standard Deviation|Mean
58297|NCT01227785|Primary|Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude|RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients|implant|55 CRT-D patients and 11 ICD patients had available data at implant.||milli volt (mV)||Standard Deviation|Mean
58298|NCT01227785|Primary|Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients|LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.|1-month|68 patients in the CRT-D cohort had available data at 1month visit||milli volt (mV)||Standard Deviation|Mean
58299|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.|pre-discharge|69 patients in the CRT-D arm had available data at pre-discharge visit.||milli volt (mV)||Standard Deviation|Mean
58300|NCT01227785|Secondary|Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.|A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2).|Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months|HF events were reported and adjudicated to classify patients into group 1 or 2. Group 1=17 HFEs in 13 patients. For patients with multiple HFEs,only the first with sufficient data was used. 8/13 with a HFE had data for the endpoint analysis.Group 2=95 patients with 9 month follow-up. 90/95 had data eligible for inclusion in the endpoint analysis.||breaths/min||Inter-Quartile Range|Median
58301|NCT01227785|Primary|Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.|implant|The number of CRT-D patients with available data at implant||milli volt (mV)||Standard Deviation|Mean
58302|NCT01227707|Secondary|TTP - Time to Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||months||Standard Deviation|Mean
58303|NCT01227707|Secondary|Time to Disease Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||percentage of participants|||Number
58304|NCT01227707|Secondary|OS - Time to Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||months||Standard Deviation|Mean
58305|NCT01227707|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population||percentage of participants|||Number
58306|NCT01227707|Secondary|DFS - Time to Event|The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population||months||Standard Deviation|Mean
58307|NCT01227707|Secondary|Disease-Free Survival (DFS) - Percentage of Participants With an Event|DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population||percentage of participants|||Number
58308|NCT01227707|Secondary|Percentage of Participants With Relapse During Follow-Up|The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population; only participants who underwent radical surgery were included in the analysis||percentage of participants|||Number
58309|NCT01227707|Secondary|Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment|The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.|BL and within 6 weeks after the completion of study treatment|ITT population||percentage of participants|||Number
58330|NCT01227629|Secondary|Trough Plasma Concentration of Dabigatran (BIBR 953)|The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.|12 weeks|All treated patients||ng/ml||Standard Deviation|Mean
58331|NCT01227629|Secondary|Activated Partial Thromboplastin Time (aPTT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability||seconds||Standard Deviation|Mean
58310|NCT01227707|Secondary|Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment|Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population||percentage of participants|||Number
58311|NCT01227707|Secondary|Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment|Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population||percentage of participants|||Number
58312|NCT01227707|Secondary|Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure||6 to 8 weeks after completion of study treatment|ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy)||percentage of participants|||Number
58313|NCT01227707|Secondary|Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)|The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.|Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)|ITT population||percentage of participants|||Number
58314|NCT01227707|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|6 to 8 weeks following completion of neoadjuvant treatment|ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis.||percentage of participants||95% Confidence Interval|Number
58315|NCT01227681|Primary|Motor Performance of Unified Parkinson's Disease Rating Scale|To assess Unified Parkinson's Disease Rating Scale part III (motor function) scores from baseline Medication-off status to Medication-off status after G-CSF injection one year. Scores of UPDRS Part III ranges from 0 to 108 and higher values indicate worse outcome.|2 years|||scores on a scale||Full Range|Mean
58316|NCT01227668|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs During Phase 2|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Weekly from Weeks 1 through 16 (end of treatment) of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2||Participants|||Number
58317|NCT01227668|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Weekly from Week 1 to Week 26 and continuously to end of treatment|All participants who took at least 1 dose of single-blind aripiprazole in Phase 1||Participants|||Number
58318|NCT01227668|Secondary|Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])|CG-I rating scale permits global evaluation of patient’s improvement over time. At baseline (BL), CGI Severity of Illness assessment is performed, in which the clinician rates severity of patient’s condition on a 7-point scale ranging from 1=no symptoms to 7=very severe symptoms. Higher total score=worse symptoms. At subsequent visits, clinician assesses patient’s improvement relative to symptoms at baseline on CGI-I 7-point scale ranging from 1=very much improved to 7=very much worse. Since the drug targets irritability symptoms, the CGI focuses on severity of irritability secondary to autistic disorder. Lower score=more improved symptoms. LOCF data set includes data recorded at a given visit or, if nothing recorded, data areccarried forward from the prior visit. For secondary endpoints (endpt), hierarchical testing was used to keep overall experiment-wise type I error rate to <=0.05. diff=difference; IS=irritability scale; PA=primary analysis; signif=significance/significantly.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.||Units on a scale||Standard Error|Mean
58332|NCT01227629|Secondary|Ecarin Clotting Time (ECT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability||seconds||Standard Deviation|Mean
58333|NCT01227629|Secondary|11-dehydrothromboxane B2 (TXB2): Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability||pg/mg Creatinine||Standard Deviation|Mean
58334|NCT01227629|Secondary|Soluble Fibrin: Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All randomised patients, only per-protocol data included.||µg/ml||Standard Deviation|Mean
58319|NCT01227668|Secondary|Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])|ABC is an informant-based checklist used to assess and classify problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0=not at all a problem to 3=the problem is severe in degree), and resolve into 5 subscales: 1) irritability, agitation; 2) lethargy, social withdrawal; 3) stereotypic behavior; 4) hyperactivity, noncompliance; and 5) inappropriate speech. The ABC can be completed by parents, special educators, psychologists, direct caregivers, nurses, and others knowing the participant. Psychometric assessment of the ABC indicates that its subscales have high internal consistency, adequate reliability, and established validity. The ABC-I Subscale Score ranges from 0 to 45, with a negative change in score signifying improvement. LOCF data set includes data recorded at a given visit or, if no observation was recorded at that visit, data carried forward from the prior visit. chg=change; BL=baseline; APR=aripiprazole; vs=versus.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.||Units on a scale||Standard Error|Mean
58320|NCT01227668|Primary|Percentage of Patients Relapsing by Week 16|"Time of relapse=date when patient meets relapse criteria. There are 4 definitions for relapse: 1. Patient meets the following criteria for 2 consecutive visits: (a) Aberrant Behavior Checklist Irritability score ≥25% than score at end of Phase 1 AND (b) Clinical Global Impression Improvement scale rating of ‘Much Worse’ or ‘Very Much Worse’ relative to rating at end of Phase 1. If relapse criteria met at 1 visit, 2nd visit should occur in about 1 week to reevaluate whether relapse criteria are still met. 2. Patient discontinues for Lost to Follow-up after a visit in which he or she met Definition 1 criteria (a&b). 3. Patient begins a prohibited drug (whether a study investigator or outside source prescribed) to treat worsening symptoms of irritability of autistic disorder after a visit where patient met Definition 1 criteria (a&b). 4. Patient discontinues due to hospitalization for worsening symptoms of irritability or due to lack of efficacy based on investigator’s assessment."|From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment|All participants who were randomized in Phase 2||Percentage of participants|||Number
58321|NCT01227655|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3~Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4~The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.~The NMSS total score is calculated by adding all domain scores (0–360), and lower scores mean less disability."|14-15 weeks|||units on a scale||Standard Deviation|Mean
58322|NCT01227655|Secondary|Parkinson’s Disease Sleep Scale (PDSS)|"The Parkinson’s disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.~Subscale has 0-10 ratings, where 0 = severe and 10 = normal~The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14-15 weeks|||units on a scale||Standard Deviation|Mean
58323|NCT01227655|Secondary|UPDRS (Unified Parkinson’s Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)|"Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint~UPDRS I evaluation of mentation, behavior, and mood~UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food~UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.~Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe~The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14-15 weeks|||units on a scale||Standard Deviation|Mean
58324|NCT01227655|Primary|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.|14-15 weeks|||minutes||Standard Deviation|Mean
58325|NCT01227629|Secondary|Severity of Adverse Events|Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.|12 weeks|Treated patients(Numbers of patients for adverse events are counted for each treatment and are in their sum greater than the total number of patients randomized as 14 patients on Dabigatran with ASA changed treatment,12 patients down titrated Dabigatran bid to qd of which one did the down titration at the same time as the stop of the ASA treatment)||participants|||Number
58326|NCT01227629|Secondary|Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline|Number of Participants with Increase of ALT to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
58327|NCT01227629|Secondary|Number of Participants With Increase of Bilirubin to >2*Baseline|Increase of Bilirubin to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
58328|NCT01227629|Secondary|Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline|Increase of AP to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
58329|NCT01227629|Secondary|Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline|Increase of AST to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases||Participants|||Number
58337|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Other Major Cardiac Events|Occurence of other major adverse cardiac events|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
58338|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Myocardial Infarction|Occurence of a myocardial infarction|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
58339|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Systemic Thromboembolism|Occurence of a systemic thromboembolism|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
58340|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Transient Ischemic Attack|Occurence of a transient ischemic attack|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
58341|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Ischemic Stroke|Occurence of an ischemic stroke (fatal or non-fatal)|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
58342|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Composite Endpoint|Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
58343|NCT01227629|Primary|Number of Participants With Minor/Nuisance Bleeding Events|All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group||Participants|||Number
58344|NCT01227629|Primary|Number of Participants With Minor/Relevant Bleeding Events|Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group||Participants|||Number
58345|NCT01227629|Primary|Number of Participants With Fatal or Life-threatening Major Bleeding Events|Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more|12 weeks|All treated patients. No statistical comparisons were performed, due to the extremely small number of events.||Participants|||Number
58346|NCT01227577|Secondary|Event-free Survival, Progression-free Survival and Overall Survival|Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Months||95% Confidence Interval|Median
58347|NCT01227577|Secondary|Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Of the 128 participants analyzed, 3 participants received an escalated dose of 400 mg b.i.d.||Participants|||Number
58348|NCT01227577|Secondary|Number of Participants With Loss of CCyR, MMR and CMR|Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.|4 years|Numbers are based on the total number of participants who achieved and experienced loss of CMR (34 participants), CCyr (93 participants) and MMR (94 participants), respectively.||Participants|||Number
58349|NCT01227577|Secondary|Time to Progression of AP/BC|Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.|4 years|Of the 128 participants analyzed, 1 participant experienced progression to AP/BC.||Months||95% Confidence Interval|Median
58350|NCT01227577|Secondary|Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)|Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
58351|NCT01227577|Secondary|Duration of CMR, CCyR and MMR|Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).||Months||Standard Deviation|Mean
58352|NCT01227577|Secondary|Time to CMR, CCyR and MMR|Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).||Months||95% Confidence Interval|Median
58402|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1|Proportion of patients seroprotected or seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1||Participants|||Number
58353|NCT01227577|Secondary|Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)|"CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).~Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses."|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
58354|NCT01227577|Primary|Number of Participants With Confirmed Complete Molecular Response (CMR)|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.||Participants|||Number
58355|NCT01227564|Other Pre-specified|Alzheimer’s Disease Medication Administration Concerns Questionnaire (AD MACQ)|The AD MACQ was administered to the study partner to address preferences for medication administration by assessing: Question a: I would find it easy to give the study medication to the patient myself. Question b: The number of times the medication was given was convenient. Question c: I would prefer to have the study medication given at home by me instead of at the doctor's office by the doctor or nurse. Question d: I would prefer to have the study medication given at home by a nurse instead of at the doctor's office by the doctor or nurse. Question e: Overall, I am satisfied with the way the medication was given.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||percentage of participants|||Number
58356|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Total Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 – 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58357|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Planning/Organization Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 – 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58358|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Prospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 – 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58359|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Retrospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 – 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58360|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Attention/Concentration Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13, and 17, with a range from 0 – 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58361|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Total Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 – 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58403|NCT01227421|Secondary|Influenza Antibody Response: Influenza B|Change in antibody titer for Influenza B|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B||Fold change in antibody titer||Inter-Quartile Range|Median
58981|NCT01219881|Secondary|Time to Extubation|Time from gas discontinuation to eye extubation after eye opening|14 days|Determined if patient passed eligibility and completed study.||Minutes||Standard Deviation|Mean
58362|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Planning/Organization Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 – 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58363|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Prospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 – 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58364|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Retrospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 – 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58365|NCT01227564|Other Pre-specified|Change From Baseline in Perceived Deficits Questionnaire (PDQ) – Subject – Attention/Concentration Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13 and 17, with a range from 0 – 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58366|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgM ELISA Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The LLOQ determined for this assay was 50 U/mL. For any anti-Aβ IgM antibody level that was below the LLOQ (50 U/mL), the LLOD defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||U/ml||95% Confidence Interval|Geometric Mean
58367|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The lower limit of quantification (LLOQ) determined for this assay was 100 U/mL. For any anti-Aβ IgG antibody level that was below the LLOQ (100 U/mL), the lower limit of detection (LLOD) defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||U/ml||95% Confidence Interval|Geometric Mean
58368|NCT01227564|Other Pre-specified|Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time|CDR is a global clinical staging instrument that was administrated by a trained rater to assess a participant’s level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. CDR global score was derived from the six domains according to a complex algorithm with emphasis on the Memory Domain score. Global CDR score = 0.5 with memory box score of 0.5. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3, with higher score indicating no significant function. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||percentage of participants|||Number
58369|NCT01227564|Other Pre-specified|Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer’s related-dementia was performed informally by the participant’s friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the other caregivers providing support on ADL, IADL and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL and supervising; and: time per day during the past month on each of ADL, IADL, and supervising. The total Other Caregiver Time per month could range from 0 – 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||hours||95% Confidence Interval|Least Squares Mean
58377|NCT01227564|Other Pre-specified|Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant’s ability to perform a variety of activities ranging from shopping, doing the laundry, simple financial transactions, comprehension of current events, some recreational or avocational activities, and reading. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
58370|NCT01227564|Other Pre-specified|Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer’s related-dementia was performed informally by the participant’s friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the primary caregiver providing support on activities of daily living (ADL), instrumental activities of daily living (IADL) and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL, and supervising; and: time per day during the past month on each of ADL, IADL and supervising. The total Primary Caregiver Time per month could range from 0 – 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||hours||95% Confidence Interval|Least Squares Mean
58371|NCT01227564|Other Pre-specified|Change From Baseline in Dependence Scale (DS) Score|An abbreviated administration (first 6 items) of the DS was used in this study. The DS is a brief study partner-completed measure which assesses the degree of support required by a subject with AD. Since the goal of treatment was to delay or arrest the processes leading to increased dependence, the DS represented a meaningful endpoint for clinical studies in AD. The dependence score was derived by summing the first 6 items of the DS. Item 1 and 2 ranged from 0 – 2 and item 3 – 6 ranged from 0 – 1. The total score was calculated by summing the score from each of the 6 items. So the total score could range from 0 – 8, with higher scores indicating greater dependence.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||Standard Deviation|Mean
58372|NCT01227564|Other Pre-specified|Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score|The ADAS-Cog is a global cognitive measure. For the following 13 items, the participants were rated: Word Recall, Commands, Construction Praxis, Delayed Word Recall Task, Naming Task, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Instructions, Spoken Language Ability, Word-Finding Difficulty in Spontaneous Speech, Comprehension, and Number Cancellation. The ADAS-cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The total score was the sum of the scores from the 13 individual items. This study used a modified 85 point scale with a scoring range of 0 to 85 (13 items). Higher scores of the 13 individual items indicated greater cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
58373|NCT01227564|Other Pre-specified|Change From Baseline in Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief, structured examination of cognitive function consisting of the 11 item: Orientation-What, Orientation-Where, Registration-Objects, Attention and Calculation, Recall, Language-Naming, Language-Repetition, Language-Comprehension, Language-Reading, Language-Writing, and Language- Drawing. MMSE total score was the sum of the 11 item scores and it ranges from 0 to 30 with higher score indicating greater cognitive functioning. If any individual item is missing, then the MMSE total score is set to missing. A positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
58374|NCT01227564|Other Pre-specified|Change From Baseline in NPI Distress Score (NPI-D)|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. For each domain, the study partner also rated his/her own ‘emotional or psychological’ distress caused by the participant’s behavior on a 6-point scale. The study partner NPI-D total score was calculated by summing the scores of the 12 sub-scale distress scores. A negative change indicated an improvement from baseline. The caregiver distress (NPI-D) total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
58375|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. If a preliminary question for each domain was answered as ‘Yes’, each domain was rated on a 4-point frequency scale and on a 3-point severity scale. If the preliminary question was answered as ‘No’, the frequency, severity, and distress scales were set to zero. A negative change indicated an improvement from baseline. For each of the 12 domains, a sub-scale score is calculated as frequency*severity and ranges from 0 to 12. The NPI total score is then calculated by summing the scores of the 12 sub-scale scores. The NPI total scores ranges from 0 to 144 with higher scores indicating greater behavioral impairment. The caregiver distress score is not included in the NPI total score.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
58376|NCT01227564|Other Pre-specified|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)|Clinical Dementia Rating (CDR) is a global clinical staging instrument that was administrated by a trained rater to assess a participant’s level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. A CDR-SOB score was derived based on individual scores from the six domains. A negative change indicated an improvement from baseline. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3. The CDR-SOB total score ranges from 0 to 18, with higher scores indicating greater dementia. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||score||95% Confidence Interval|Least Squares Mean
60971|NCT01196923|Primary|Acute Isolation of Pulmonary Veins.|99% of pulmonary veins were isolated (72/73)|Acute PVI measured on the day of treatment|All treated participants with reported data.||percent isolated pulmonary veins|||Number
58378|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychological Test Battery (NTB)|The NTB evaluated cognitive domains that are known to be affected early in the course of Alzheimer's disease (AD). The cognitive tests included in the NTB were: Rey Auditory Verbal Learning Test – Immediate recall, Detection, Identification, Go-No-Go Task, One Back Task, Controlled Oral Word Association Test, Category Fluency Test, and Rey Auditory Verbal Learning Test – delayed recall and recognition. For each of the eight NTB components, an individual z-score was derived based on the primary raw score of each test. Based on the individual z-scores, a composite z-score was derived using the formula: (z1-z2-z3-z4+z5+z6+z7+z8)/8. Positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||z-scores||95% Confidence Interval|Least Squares Mean
58379|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right|Right HBSI measures the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
58380|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left|Left HBSI measures the left hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
58381|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total|Left HBSI and Right HBSI respectively measure the left hippocampal atrophy and the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans. HBSI (Total) is defined as the summation of the left HBSI and the right HBSI.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
58382|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)|VBSI measures ventricular volume change from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
58383|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)|BBSI measures whole brain atrophy from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans from the initial scan (baseline).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||mL||95% Confidence Interval|Least Squares Mean
58384|NCT01227564|Other Pre-specified|Change From Baseline in Plasma Aβ x-40|Site personnel collecting the samples for plasma Aβ (x-40) concentrations and the results were blinded to the participant treatment group assignment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.||pg/mL||95% Confidence Interval|Least Squares Mean
58385|NCT01227564|Other Pre-specified|Change From Baseline in CSF Total Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
58386|NCT01227564|Other Pre-specified|Change From Baseline in CSF p-Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
58387|NCT01227564|Other Pre-specified|Change From Baseline in CSF Aβ x-42|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
58388|NCT01227564|Other Pre-specified|Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at the Early termination (ET) visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.||μg/ml||95% Confidence Interval|Least Squares Mean
58389|NCT01227564|Primary|Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)|Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.|104 weeks|The full analysis set (FAS) population included all randomized participants who had at least one dose of investigational product.||ratio||95% Confidence Interval|Least Squares Mean
58390|NCT01227512|Secondary|Percentage of Participants Requiring Rescue Therapy for Hyponatremia|Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia.|7 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 3 participants in the placebo group.||Percentage of participants|||Number
58391|NCT01227512|Secondary|Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2.|Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7.|48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 2 participants in the tolvaptan group and 3 participants in the placebo group.||Percentage of participants|||Number
58392|NCT01227512|Secondary|Time to First 2-point Improvement in CGI-S Score.|CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours.|Up to 72 hours|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 1 participant in the tolvaptan group and 3 participants in the placebo group.||Hours||95% Confidence Interval|Median
58393|NCT01227512|Secondary|Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]).|"Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed.~A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose.~Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours."|0 to 72 hours|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for 3 participants in the tolvaptan group and 1 participant in the placebo group."||mEq/L||Full Range|Least Squares Mean
58394|NCT01227512|Secondary|Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms.|"Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed.~The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse"|Baseline to 48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were not available for 2 participants in the tolvaptan group.||Units on a scale||Full Range|Median
58395|NCT01227512|Secondary|Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms.|"Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed.~The CGI-S is a one-question rating scale which was as follows: “Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?” 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 24 and 72 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group."||Units on a scale||Full Range|Median
58396|NCT01227512|Secondary|Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms.|"Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed.~The CGI-S is a one-question rating scale which was as follows: “Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?” 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 48 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group."||Units on a scale||Full Range|Median
58397|NCT01227512|Primary|Length of Hospital Stay (LoS)|LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors.|45 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.||Days||95% Confidence Interval|Median
58398|NCT01227434|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants with protocol related toxicity described by CTCAE version 4.0|1-2 years|||participants|||Number
58399|NCT01227434|Primary|Progression Free Survival|Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.|up to 142 weeks|||weeks||Full Range|Mean
58400|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B||Participants|||Number
58401|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A H3N2||Participants|||Number
58405|NCT01227421|Secondary|Influenza Antibody Response Titer Change: Influenza A 2009 H1N1|change in influenza antibody titer for Influenza A 2009 H1N1|28 days|Member of the intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1||Fold change in antibody titer||Inter-Quartile Range|Median
58406|NCT01227421|Secondary|Complications of Influenza|Proportion of patients with a complication of influenza during the course of the study|28 days|All patients who received at least one dose of study medication||Participants|||Number
58407|NCT01227421|Secondary|Time Loss From Work|Time loss from work|28 days|Analysis conducted on 241 patients with laboratory confirmed influenza excluding those who are unemployed||days||95% Confidence Interval|Mean
58408|NCT01227421|Secondary|Symptom Severity Score Hours|Sum of the symptom severity score hours from first dose to resolution of symptoms. Patients rated each symptom's severity on a score from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Total symptom severity score hours were calculated by multiplying the sum of the severity scores by duration of symptoms.|28 days|Analysis conducted for 257 patients with laboratory confirmed influenza||symptom score *hour||Standard Deviation|Mean
58409|NCT01227421|Secondary|Time to Return to Normal Daily Activities|Time in hours as reported by patient|28 days|Analysis conducted on 257 patients with laboratory confirmed influenza||Hours||Inter-Quartile Range|Median
58410|NCT01227421|Secondary|Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50)|Median time in hours|28 days|Analysis performed on 107 patients from the intensive virologic follow up population with laboratory confirmed influenza||Hours||Inter-Quartile Range|Median
58411|NCT01227421|Secondary|Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline|Change in viral titer logarithm with base 10 (log10) Ribonucleic Acid (RNA)copies|7 days|Analysis conducted on 113 patients from the intensive virologic follow up group with laboratory confirmed influenza||LOG10 RNA copies||Standard Deviation|Mean
58412|NCT01227421|Secondary|Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline|Change in viral titer presented as logarithm with base 10 (log10) 50% Tissue Culture Infective Dose (TCID50)|7 days|Analysis conducted on 113 patients from intensive virologic follow up group with laboratory confirmed influenza||LOG10 Titer||Standard Deviation|Mean
58413|NCT01227421|Secondary|Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects|Time in hours (Median and Interquartile range)|at least 28 days|624 patients were enrolled based on inclusion/exclusion criteria. Secondary efficacy analyses were conducted on the 257 patients with laboratory confirmed influenza.||Hours||Inter-Quartile Range|Median
58414|NCT01227421|Primary|Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects|The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection|Up to 28 days|624 patients were enrolled based on inclusion/exclusion criteria. The primary efficacy analysis was conducted on the 257 patients with laboratory confirmed influenza.||Hours||Inter-Quartile Range|Median
58415|NCT01227395|Secondary|Number of Participants Prevented by Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
58416|NCT01227395|Secondary|Number of Participants That Responded to Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
58417|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58418|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58419|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58420|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58421|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58422|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58423|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.||participants|||Number
58424|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58425|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
58426|NCT01227395|Primary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|9 years(MAX)|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.||Events|||Number
58427|NCT01227395|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.|9 years(MAX)|No statistical analysis provided for the frequency of treatment related adverse events.||participants|||Number
58428|NCT01227382|Secondary|Adverse Events|Adverse events were prospectively evaluated at the end of the procedure, at discharge from the endoscopy unit, and by telephone call 24 hours post procedure. Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria.|24 hours|Percentage of participants with accurate diagnoses of cancer||participants|||Number
58429|NCT01227382|Secondary|Sampling Times for Each Device|The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).|15 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
58430|NCT01227382|Secondary|Cholangioscopy Visualization Time|The portion of the total ERCP time spent on Cholangioscopy visualization.|30 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
58431|NCT01227382|Secondary|Total Cholangioscopy Time|This is the total time it takes for the dye to be performed during the ERCP.|60 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
58432|NCT01227382|Secondary|Total Procedure Time|The total time to perform ERCP|120 minutes|Percentage of participants with accurate diagnoses of cancer||minutes||Standard Deviation|Mean
58433|NCT01227382|Secondary|Procedure Technical Success|The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.|day 1|Percentage of participants with accurate diagnoses of cancer||participants|||Number
58434|NCT01227382|Primary|Percentage of Participants With Accurate Diagnoses of Cancer|The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.|up to 7 days after the procedure|Percentage of participants with accurate diagnoses of cancer||percentage of accurate diagnoses|||Number
58435|NCT01227278|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Deviation|Mean
58436|NCT01227278|Secondary|Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of participants|||Number
60972|NCT01196741|Secondary|Median PFS||From first saracatinib/placebo dose to first documented progression and/or death, assessed up to 36 months|||months||95% Confidence Interval|Median
58437|NCT01227278|Secondary|Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Deviation|Mean
58438|NCT01227278|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total Score|SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of participants|||Number
58439|NCT01227278|Secondary|Change From Baseline in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||units on scale||Standard Deviation|Mean
58440|NCT01227278|Secondary|Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||hospitalizations/person-year||95% Confidence Interval|Number
58441|NCT01227278|Secondary|Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||percentage of participants|||Number
58442|NCT01227278|Secondary|Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||participants|||Number
58443|NCT01227278|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to 561|The safety population included all participants who received at least one dose of investigational drug.||participants|||Number
58444|NCT01227278|Primary|Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.|Day 1 up to 393|The per protocol (PP) population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.||AECOPD events/person-year||95% Confidence Interval|Number
58455|NCT01227018|Other Pre-specified|Biomarker Evaluation|Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.|Pre-treatment and 1 week post-treatment|The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed.|||||
61196|NCT01195090|Secondary|Percentages of Patients With Nasopharyngitis|Proportion of Nasopharyngitis after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
58445|NCT01227265|Primary|Change From Baseline in Total Epworth Sleepiness Scale (ESS) at Week 12|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness. The mean change from baseline in total EES was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Score on a Scale||Standard Error|Mean
58446|NCT01227265|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Percentage of participants|||Number
58447|NCT01227265|Primary|Number of Participants With Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg Increase|The number of participants with Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Participants|||Number
58448|NCT01227265|Primary|Number of Participants With Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg Increase|The number of participants with Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.||Participants|||Number
58449|NCT01227265|Secondary|"Change From Baseline in Average On Time (Hours Per Day) Without Troublesome Dyskinesia at Week 12"|"On time is when a PD participant's symptoms are improved. Mean on time without troublesome dyskinesias is derived from the available diary data collected for 3 days immediately prior to a clinic visit. On time without troublesome dyskinesia is the sum of on time without dyskinesia plus on time with non-troublesome dyskinesia as recorded in the diary. The mean change from baseline in on time was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.||hours per day||Standard Error|Mean
58450|NCT01227265|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"A participant with at least a 30% reduction in mean off time from Baseline to End of Treatment (Week 12) is considered as responder. The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week 12 visit."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least one dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.||Percentage of participants|||Number
58451|NCT01227265|Primary|"Change From Baseline in Average Off Time (Hours Per Day) at Week 12"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week 12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis (cLDA) with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.||hours per day||Standard Error|Mean
58452|NCT01227057|Secondary|Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months|The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment.|6 months|||units on a scale||Standard Deviation|Mean
58453|NCT01227057|Secondary|Change in Functional Impairment as Measured by the Activities of Daily Living, Functional Disability Index, Clutter Image Rating Scale||5 years||||||
58454|NCT01227057|Primary|Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months|Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.|6 months|||units on a scale||Standard Deviation|Mean
58456|NCT01227018|Secondary|Number of Patients With Each Worst Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity related to study treatment. One patient withdrew before treatment. One patient did not have a toxicity related to study drug or therapy.||participants|||Number
58457|NCT01227018|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|study entry to date of death or last date known alive (assessed over 2.5 yrs)|All patients are included in the analysis on intention‐totreat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
58458|NCT01227018|Secondary|Best Response|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date, to date of disease progression (assessed up to 1 year)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non‐evaluable for best overall response.||participants|||Number
58459|NCT01227018|Primary|Disease Control Rate|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.|at 8 weeks from the start of therapy|Patients who received treatment and who were available for determination of response.||percentage of participants|||Number
58460|NCT01227005|Secondary|30-day Mortality|Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy|first 30 days after ED admission|||participants|||Number
58461|NCT01227005|Secondary|24-hour Mortality|Mortality rate at 24 hours after arrival|First 24 hours after ED admission|||participants|||Number
58462|NCT01227005|Primary|In a Prospective, Randomized Trial, Evaluate Transfusion of Stored Whole Blood and Pooled Platelets During Transfusion Therapy.|Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)|first 24 hours after ED admission|||units of blood||Inter-Quartile Range|Median
58463|NCT01226745|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 35 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
58464|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination|A whole body examination, paying particular attention to identify precancerous or cancerous lesions was done by a dermatologist and based on the clinical judgment of the dermatologist the abnormalities were categorized as clinically significant or clinically not significant. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline up to end of the treatment, assessed up to Week 255|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
58465|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination|Subjects underwent comprehensive ophthalmic examination (COE) including best corrected visual acuity (Snellen), manifest refractions, pupil examination, ocular motility, nystagmus, confrontation visual fields, Ishihara color plates, Amsler grid, and tonometry as well as a biomicroscopy slit lamp examination of the conjunctiva, cornea, anterior chamber, iris and lens; and a fundoscopic examination (with dilation) of the vitreous, optic nerve, retinal vessels, macula, and peripheral retina. Optical Coherence Tomography (OCT): Thicknesses of the macular retina and retinal nerve fiber layer at the optic nerve head in each eye was assessed by OCT using the fast macular thickness map scan and the fast retinal nerve fiber layer (RNFL) scan features, respectively. The abnormalities of the ophthalmologic examination was judged to be clinically significant or not as per the investigators discretion. The ophthalmologic examination was performed for both right eye (RE) and left eye (LE).|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.||Subjects|||Number
58466|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures|The 12-lead ECG was recorded after the subject was in supine position for 5 minutes. ECGs were acquired on digital cardiographs. Abnormal findings were analyzed as clinically significant or not clinically significant as per the discretion of the study investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
58478|NCT01226719|Secondary|To Determine the Acute Toxicity Produced by This Regimen.|The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.|18 months|All patients on study||participants|||Number
87992|NCT00928720|Secondary|Blood Pressure Using the Omron HEM-711DLX Upper Arm Blood Pressure Monitor||at baseline and daily over 8 weeks||||||
58467|NCT01226745|Primary|Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)|DLCO was one of the most clinically valuable tests of lung function. The DLCO measure the ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject was early terminated from the study during the additional 2 year period with delay. The values for the DLCO “% of predicted” was defined as the mean value of 2 test results that were within a 10% variability of each other.|Baseline, Week 40, 52, early termination, Week 152, 200, 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.||Percentage of predicted value||Standard Deviation|Mean
58468|NCT01226745|Primary|Change From Baseline in Forced Vital Capacity (FVC)|FVC (% of predicted value) was the volume of air which was forcibly exhaled from the lungs after taking the deepest breath possible. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure||Percentage of predicted value||Standard Deviation|Mean
58469|NCT01226745|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)|FEV1 was defined as the maximal volume of air exhaled in the 1st second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.||Percentage of predicted value||Standard Deviation|Mean
58470|NCT01226745|Secondary|Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment|Brain volume was obtained by magnetic resonance imaging (MRI). Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. Brain volume changes very little over time. Hence, the PBVC at the end of treatment was calculated by adding up all the PBVC values from the scans performed during the extension treatment period.|Baseline and at end of treatment (Week 255)|FAS included all subjects who provided any post baseline efficacy data. One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.||Percent brain volume||Standard Deviation|Mean
58471|NCT01226745|Secondary|Change From Baseline in Lesion Volume at the End of the Treatment (EoT)|Brain lesion volume was obtained by magnetic resonance imaging (MRI). Extension study baseline was defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EOT) was defined as the last visit during the treatment period. Change from extension baseline to EOT = last treatment period value in extension study — extension baseline value.|Baseline, End of treatment (5 years)|FAS included all subjects who provided any post baseline efficacy data.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.||Cubic centimeter (cc)||Standard Deviation|Mean
58472|NCT01226745|Secondary|Number of Gadolinium (Gd)-Enhanced Lesions|Gd-enhanced lesions were obtained by magnetic resonance imaging (MRI) at each scheduled assessment visit over the study period. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EoT) lesion count is the average number of lesion counts per scan, calculated by dividing the sum of all lesion counts by number of scans during the extension treatment period. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study.Full Analysis Set (FAS) included all subjects who provided any post baseline efficacy data.|Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)|"FAS. n” signifies the number of subjects analyzed for individual time point in the outcome measure.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period."||Lesions||Standard Deviation|Mean
58473|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Vital Signs|Vital signs included oral temperature, pulse, respiration rate and blood pressure (BP) (taken after 5 minutes in the sitting position). The abnormalities in vital signs were decided as clinically significant or not based on the clinical judgment of the investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.||Subjects|||Number
58474|NCT01226732|Secondary|Preliminary Efficacy Assessment: Response Rate (RR)|Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Includes all patients evaluable for response (4 patients were not evaluable)||participants|||Number
58475|NCT01226732|Secondary|Safety|To evaluate the drug related toxicities associated with different doses of the drugs used in this regimen.|18 months|||participants|||Number
58476|NCT01226732|Primary|Dose Determination|To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors.|18 months|||mg/m^2|||Number
58477|NCT01226719|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|All patients on study||months||95% Confidence Interval|Median
58479|NCT01226719|Secondary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study||months||95% Confidence Interval|Median
58480|NCT01226719|Secondary|R0 Resection Rate|To determine the rate of complete (R0) resection for patients treated with this regimen.|18 months|Includes patients who were surgical candidates and underwent surgery on study||percentage of patients with surgery|||Number
58481|NCT01226719|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients deemed to be evaluable for response who were evaluated for response||percentage of evaluable participants|||Number
58482|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal behavior score at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal behavior score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
58483|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal ideation score <5 at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal ideation score during the extension treatment period. Nine (9) participants from 1 site with major quality issues were excluded.||percentage of participants|||Number
58484|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGAS score during the acute treatment period and at least 1 CGAS score during the extension treatment period [last observation carried forward (LOCF)], excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58485|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGI-S score during the acute treatment period and at least 1 CGI-S score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58486|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity total score during the acute treatment period and at least 1 PARS severity total score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58487|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity score for GAD during the acute treatment period and at least 1 PARS severity score for GAD during the extension treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58527|NCT01225991|Secondary|Visual Analogue Scale to Evaluate Fatigue (VAS-F)|Fatigue: Repeated assessment of fatigue severity across the day will utilize the Visual Analogue Scale to Evaluate Fatigue (VAS-F).|Week 1 and 12||||||
58488|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal behavior score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
58489|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal ideation score during the acute treatment period, whose baseline maximum C-SSRS suicidal ideation score was <5. Nine (9) participants from 1 site with major quality issues were excluded.||percentage of participants|||Number
58490|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline [last observation carried forward (LOCF)] CGAS score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58491|NCT01226511|Secondary|Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale|Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.|10 weeks|Randomized participants with at least 1 post-baseline CGI-S score [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
58492|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline CGI-S score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58493|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity total score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58494|NCT01226511|Secondary|Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD|Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||percentage of participants|||Number
58495|NCT01226511|Primary|Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD during the acute treatment period, excluding 9 participants from 1 site with major quality issues.||units on a scale||Standard Error|Least Squares Mean
58496|NCT01226459|Primary|Subject Assessment of Scalp Coverage|Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.|Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Eighteen participants in vehicle foam group and 23 participants in minoxidil foam group had no scalp coverage information.||scores on a scale||Standard Deviation|Mean
58497|NCT01226459|Secondary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 12|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in the vehicle foam group and 3 participants in the minoxidil foam group had no hair count information at Baseline.||hairs per centimeter squared||Standard Error|Mean
58498|NCT01226459|Primary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in minoxidil foam group had no hair information at Baseline.||hairs per centimeter squared||Standard Deviation|Mean
58499|NCT01226420|Secondary|Safety of Alefacept Infusions in Patients With Chronic GVHD.|Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.|2 years|All enrolled subjects were included in the Analysis of Safety Events||Total adverse events|||Number
58500|NCT01226420|Primary|Efficacy|Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.|2 years|All enrolled subjects||participants|||Number
58501|NCT01226121|Secondary|Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)||90 days|||percentage of patients|||Number
58502|NCT01226121|Primary|Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)||30 days after injection|||percentage of participants|||Number
58503|NCT01226095|Secondary|Number of Participants Who Experienced Adverse Events and Serious Adverse Events|Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 4 weeks|The tolerability population included all enrolled participants.||participants|||Number
58504|NCT01226095|Secondary|Number of Participants With the Ability to Carry Out Normal Activities at Each Visit|The number of participants who were able or unable to carry out normal activities was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||participants|||Number
58505|NCT01226095|Secondary|Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)|The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.|2 and 4 weeks|Data were analyzed for all participants for which data were available.||participants|||Number
58506|NCT01226095|Primary|Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).|Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.|4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||Participants|||Number
58507|NCT01226095|Secondary|Duration of Morning Stiffness|The duration of morning stiffness in minutes was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, however, only participants with available morning stiffness data were included in the analysis for each visit.||minutes||Standard Deviation|Mean
58508|NCT01226095|Secondary|Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).|Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.|2 and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||Participants|||Number
58509|NCT01226095|Secondary|Number of Participants With Joint Tenderness/Stiffness at Each Visit|Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||participants|||Number
58510|NCT01226095|Secondary|Percent of Participant Compliance|The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).|2 and 4 weeks|Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken.||percentage of participant compliance|||Number
58511|NCT01226095|Primary|Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.|Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.|Baseline and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.||units on a scale||Standard Deviation|Mean
58512|NCT01226043|Other Pre-specified|Number of Patients With Hypoglycemic Events|The hypoglycemic event was to be recorded on the electronic case report form hypoglycemia page and had to fit in one of the following categories: Mild-to-moderate hypoglycemia (36 mg/dL ≤ Self Monitored Blood Glucose (SMBG) <70mg/dL), Severe hypoglycemia (assistance of another person is required, and either a recorded SMBG <36 mg/dL, or treatment with oral carbohydrates, intravenous glucose or glucagon with prompt response) or Hypoglycemia symptoms with or without SMBG values with a documented SMBG >70 mg/dL, or no recorded SMBG value. Only hypoglycemia events associated with coma, loss of consciousness or seizure were considered serious adverse event (SAEs).|each study phase (crossover, re-randomization, observational) up to 40 weeks|The safety population for each phase (crossover, re-randomization, observational) was the total treated population defined as all the patients who were randomized and exposed to at least one dose of Lantus during that phase.||participants having reported the event|||Number
58513|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Observational Phase||From week 10 to week 40 (observational phase)|Re-randomized population at week 4 and included in the observational phase at week 10 and exposed to at least one dose of the IP||percentage of patients|||Number
58514|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase||From week 4 to week 10 (re-randomization phase)|Re-randomized population at week 4 exposed to at least one dose of the IP||percentage of patients|||Number
58515|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase||From baseline to week 4 (crossover phase)|Randomized population (crossover phase) exposed to at least one dose of the IP||percentage of patients|||Number
58516|NCT01226043|Secondary|Time to First Observation of HbA1c <7%||From week 10 to week 40 (observational phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of HbA1c.||Days since Re-randomization (week 4)||95% Confidence Interval|Median
58517|NCT01226043|Secondary|Percentage of Patients Achieving HbA1c Goal|Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)|measured at week 40 or at study discontinuation|Patients from the mITT population for Re-randomization and Observational Phases who had at least one post re-randomization assessment of HbA1c.||percentage of patients|||Number
58518|NCT01226043|Secondary|Change in Lantus Dose Injected Per Day||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG.||U (insulin unit)||Standard Error|Least Squares Mean
58519|NCT01226043|Secondary|Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL||At week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had a re-randomization baseline assessment FPG > or = 110 (week 4) and at least one post re-randomization assessment of FPG.||percentage of patients|||Number
58520|NCT01226043|Secondary|Change in Fasting Plasma Glucose (FPG)||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG measured during the on-treatment period.||mg/dL||Standard Error|Least Squares Mean
58521|NCT01226043|Secondary|Healthcare Professional's (HCP) Recommendation|"The overall recommendation score was obtained from the question 20d of the Healthcare Professional Questionnaire: “Overall, how strongly would you recommend each of the insulin delivery systems for your patients?”~5 points scale: from 1= Not Recommended to 5= Recommended"|At week 4 (end of crossover phase)|"The HCP Questionnaire analysis population consisted of HCPs:~who treated at least 1 randomized patient during the crossover phase and this(these) patient(s) received at least one dose of Lantus via both insulin delivery systems during the crossover phase~who completed the HCP Questionnaire."||units on a scale||Full Range|Median
58522|NCT01226043|Secondary|Patient Preference Composite Score|"The patient preference composite score was the sum of the scores of the 3 following individual preference questions from the Patient preference Questionnaire:~Question 14a: How strongly do you prefer each of these insulin delivery systems to control blood sugar?~Question 14b: If using insulin for the first time, how strongly would you prefer using each of these delivery systems to overcome reluctance to use insulin?~Question 14c: How strongly would you prefer each insulin delivery system for long-term use?~Each individual question scored from 1 to 5. The lowest score 1 indicated 'Not Preferred' and the highest score 5 indicated 'Always Preferred'. Therefore the total range of the composite score was 3 to 15."|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered to the 3 questions 14a, 14b and 14c.||units on a scale||95% Confidence Interval|Least Squares Mean
58523|NCT01226043|Primary|Patient Overall Preference|"The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d “Overall, what is your level of preference for each of the insulin delivery systems?”~5 points scale: from 1=Not preferred to 5= Always preferred"|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered question 14d.||units on a scale||95% Confidence Interval|Least Squares Mean
58524|NCT01225991|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|Resilience: the Connor-Davidson Resilience scale (CD-RISC) quantifies stress coping ability.|Week 1 and 12||||||
58525|NCT01225991|Secondary|Profile of Mood States (POMS)|Depressive symptoms: Repeated assessment of depressive symptoms severity will be made using the Profile of Mood States (POMS).|Week 1 and 12||||||
58526|NCT01225991|Secondary|(UKU) Side Effects Rating Scale Profile|Will rate the frequency and intensity of emerging adverse events.|12 weeks- each visit||||||
58528|NCT01225991|Primary|Pain Rating Index|Pain & Stiffness: Repeated assessments of pain and stiffness across the day will utilize the Pain Rating Index (PRI), consisting of the sum of the ranked values associated with adjectives depicting the severity of pain from the McGill Pain Questionnaire (MPQ). Sixty joints will be evaluated on a scale from 0 (none) to 3 (severe), to indicate the extent of pain/tenderness and swelling. The final score was summed for this measure with a range from 0 (no pain) to 45 (worst possible pain).|Change score at baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
58529|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58530|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58531|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58532|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58533|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58534|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58535|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58536|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58537|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58538|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58539|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58540|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58541|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58542|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58543|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58544|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58545|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
58546|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
58547|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
58548|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|||log contrast sensitivity units|Participants|Standard Deviation|Mean
58549|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing||log contrast sensitivity units|Participants|Standard Deviation|Mean
58550|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing||log contrast sensitivity units|Participants|Standard Deviation|Mean
58551|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58552|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units||Standard Deviation|Mean
58553|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing||log contrast sensitivity units|Participants|Standard Deviation|Mean
58554|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set||log contrast sensitivity units|Participants|Standard Deviation|Mean
58555|NCT01225926|Primary|Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3|Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.|Month 3|Per protocol: All subjects who received IOLs in both eyes and followed the protocol with no major protocol deviations.||logMAR||Standard Deviation|Mean
58556|NCT01225835|Secondary|Summary of Pregnancy Outcome|Pregnancy outcomes were reported at the optional long-term follow up visit.|up to 10 months|Per protocol set of participants who reported information during the optional long-term follow up visit.||participants|||Number
58557|NCT01225835|Secondary|Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test|A pelvic ultrasound scan was performed approximately 6 weeks after the first positive pregnancy test and the presence of an active foetal heart action indicated a clinical pregnancy.|approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test|Per protocol set||percentage of participants|||Number
58558|NCT01225835|Secondary|Number of Ampoules of Gonadotrophins Used|Number of ampoules of gonadotrophins used with the goal of reaching hCG criteria. Each ampoule contained 75 IU of either menotrophin or follitrophin alpha.|Day 1 up to Day 12|Per protocol set||ampoules||Standard Deviation|Mean
58559|NCT01225835|Secondary|Number of Days Stimulated With Gonadotrophins|Number of days in which gonadotrophins were administered until hCG criteria were met. If hCG criteria were not met by day 13, the participant was withdrawn from the study.|Day 1 up to Day 12|Per protocol set||days||Standard Deviation|Mean
58560|NCT01225835|Secondary|Percentage of Participants With Successful Embryo Transfer||approximately day 18|Per protocol set||percentage of participants|||Number
58561|NCT01225835|Secondary|Estradiol (E2) Levels on Day of hCG Administration||approximately day 10|Per protocol set. Five participants from each treatment arm were missing blood samples.||ng/ml||Standard Deviation|Mean
58562|NCT01225835|Secondary|Endometrial Thickness on Day of hCG Administration|Endometrial thickness was assessed by pelvic ultrasound on the day of hCG administration.|approximately day 10|Per protocol set of participants. One participant in the Follitrophin Alpha arm was missing a measurement.||mm||Standard Deviation|Mean
58563|NCT01225835|Secondary|Number of Frozen Oocytes at Pronuclear Stage|No more than three normally developed embryos were transferred 2-3 days after oocyte retrieval. Other normally developed embryos were frozen.|approximately day 14|Per protocol set of participants who had embryos transferred||oocytes||Standard Deviation|Mean
58564|NCT01225835|Secondary|Best Quality of an Embryo Transferred|"Embryo quality was measured by the following grades:~Grade 1: Evenly sized cells, regular cleavage, no fragmentation~Grade 2: Regular or slightly irregular cleavage, <=20% fragmentation~Grade 2.5: Regular or slightly irregular cleavage, >20%and <=50% fragmentation~Grade 3: Irregular cleavage, >50% fragmentation, >1 intact cell~Grade 4: Extensive fragmentation, only 1 cell intact~Grade 5: Totally fragmented, no viable cells.~Grade 1 represents the healthiest embryos and Grade 5 embryos are not viable."|approximately day 14|Per protocol set of participants who had embryos transferred||participants|||Number
58565|NCT01225835|Secondary|Number of Embryos Transferred|Mean number of embryos transferred 2-3 days following oocyte retrieval.|approximately day 14|The per-protocol (PP) set who had embryos transferred. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||embryos||Standard Deviation|Mean
58566|NCT01225835|Secondary|Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade|"The count of participants with different quality grades of pronuclear stage oocytes is offered. Pronuclear stage oocytes are categorized into seven grades (0A, 0B, 1-5) representing different patterns of pronuclear morphology, according to the German Pronuclear Morphology Study Group. 0A is the highest quality oocyte and grade 5 is the lowest quality.~Participants can have pronuclear stage oocytes of different grades and therefore are counted more than once."|approximately day 13|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||participants|||Number
58567|NCT01225835|Secondary|Number of Pronuclear Oocytes|Pronuclear oocytes are fertilized oocytes.|approximately day 13 after study start|The per-protocol (PP) set of participants with non-missing values.||oocytes||Standard Deviation|Mean
58568|NCT01225835|Secondary|Number of Cumulus-oocyte Complexes Retrieved|Cumulus-oocyte complexes are oocytes with surrounding cumulus cells.|approximately day 12 after study start|The per-protocol (PP) set of participants with non-missing values.||oocytes||Standard Deviation|Mean
58570|NCT01225835|Secondary|Number of Follicles at hCG Administration|Number of follicles >=17 mm diameter detected by pelvic ultrasound examination at day of hCG administration.|approximately day 10|The per-protocol (PP) set of participants with non-missing values. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||follicles||Standard Deviation|Mean
58571|NCT01225835|Secondary|Percentage of Participants With Ongoing Pregnancy|Ongoing pregnancy is defined as having a positive foetal heart action nine or more weeks after the first positive pregnancy test.|approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).||percentage of participants|||Number
58572|NCT01225835|Secondary|Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration|The influence of the progesterone level on the ongoing pregnancy rate (in relation to all randomized patients) was determined by means of the receiver operating characteristic (ROC) curve. Youden's Index (sensitivity + specificity -1) has a range of 0-1, with 0.5 indicating a random effect.|Day 7, approximately Day 10 (hCG Administration)|Full analysis set||Youden's index|||Number
58573|NCT01225835|Primary|Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration|Ovulation induction was performed by administration of hCG once three follicles >=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (<39 years and >=39 years).|approximately day 10|Full analysis set||ng/ml||Standard Deviation|Mean
58574|NCT01225822|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval|Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.|up to day 8+/-2 days visit|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
58575|NCT01225822|Secondary|Plasma Concentration (Cmax) of Dabigatran|"Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state.~Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state.~Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state"|Day 1 to end of treatment|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
58576|NCT01225822|Secondary|Laboratory Analyses|"Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Haematocrit [%]: (0.35-0.45) for women and (0.39−0.51) for men Haemoglobin [g/dL]: (11.6−15.4) for women and (13.2−17.3) for men White Blood Cell count [10^9/L]: (4-10.3) for women and (3.9−10.3) for men Platelets [10^9/L]: (145-420) for women and men Sodium [mmol/L]: (135-146) for women and men Potassium [mmol/L]: (3.5-5) for women and men Aspartate aminotransferase (AST) [U/L]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) [U/L]: (8-43) for women and (8-45) for men Alkaline Phosphatase [U/L]: (36-118) for women and (35-123) for men Creatinine [mg/dL]: (0.57-1.06)for women and (0.72−1.3) for men Bilirubin, total [mg/dL]: (0.22-1.28) for women and men Uric acid [mg/dL]: (2.4-6.47) for women and men"|Screening to end of treatment|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||participants|||Number
58577|NCT01225822|Secondary|Number of Participants With Clinically Significant, Minor or Any Bleeding Events|"Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as~Spontaneous skin haematoma larger than >25 cm²~Wound haematoma >100 cm²~Spontaneous nose bleed >5 minutes~Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention~Spontaneous rectal bleeding (more than spot on toilet paper)~Gingival bleeding >5 minutes~Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events."|Treatment period (up to day 8+/-2 days visit)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||participants|||Number
58578|NCT01225822|Secondary|Rate of Transfusions Due to Bleedings|Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||Percentage of patients|||Number
58579|NCT01225822|Secondary|Volume of Blood Loss|Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||ml||Standard Deviation|Mean
58580|NCT01225822|Primary|Number of Participants With Major Bleeding Events (MBE)||From approximately 14 days prior to surgery to 4-6 weeks post surgery|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data||participants|||Number
58581|NCT01225822|Secondary|Number of Participants With Proximal DVT|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
58582|NCT01225822|Secondary|Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period or PE confirmed by objective testing plus VTE related mortality|Treatment period (up to day 10)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
58982|NCT01219881|Secondary|Difference in Time to Orientation|Difference in time to orientation as measured by SOMCT between the desflurane group and the sevoflurane group|14 Days|Determined if patient passed eligibility and completed study.||Minutes||Inter-Quartile Range|Median
58583|NCT01225822|Secondary|Number of Participants With VTE Events and All Cause Mortality|Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths.|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
58584|NCT01225822|Primary|Number of Participants With Venous Thromboembolic (VTE) Events|Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery||participants|||Number
58585|NCT01225731|Primary|Number of Particpants Discontinuing Study Treatment Due to Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.|Up to 52 weeks|All particpants receiving at least one dose of study drug during the treatment period.||Participants|||Number
58586|NCT01225731|Primary|Number of Participants Experiencing Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 72 weeks|All participants receiving at least one dose of study drug.||Participants|||Number
58587|NCT01225731|Secondary|Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.||Percentage of participants|||Number
58588|NCT01225731|Secondary|Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint, excluding all participants on the placebo arm.||Percentage of participants|||Number
58589|NCT01225731|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.||Score on a scale||95% Confidence Interval|Mean
58590|NCT01225731|Secondary|Percentage of Participants With PASI 50 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 50 response was defined as >=50 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
58591|NCT01225731|Secondary|Mean Change From Baseline in PASI Score at Weeks 12 and 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).|Baseline and Weeks 12 and 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for Week 12 and Week 16.||Score on a scale||95% Confidence Interval|Mean
58615|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|1 month post-optimal cosmetic result|All subjects completing indicated visit||Participants with improved self-esteem|||Number
58592|NCT01225731|Secondary|PASI 75 Response Rate by Time|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score at Week 2, 4, 6, 8, 12, or 16.|Up to 16 Weeks|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. and data for the specific Week.||Percentage of participants|||Number
58593|NCT01225731|Secondary|Percentage of Participants With PASI 100 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data fior this endpoint||Percentage of participants|||Number
58594|NCT01225731|Secondary|Percentage of Participants With PASI 90 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 90 response was defined as >=90 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint.||Percentage of participants|||Number
58595|NCT01225731|Secondary|Percentage of Participants With Physician’s Global Assessment (PGA) of “Cleared” or “Minimal” at Week 16|The PGA is used to determine the overall severity of a subject’s psoriasis lesions at a given time point. Overall lesions will be graded for induration, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PGA value was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
58596|NCT01225731|Secondary|Percentage of Participants With a PASI 75 Response at Week 12|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 12|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
58597|NCT01225731|Primary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.||Percentage of participants|||Number
58983|NCT01219881|Primary|Recovery Time|Recovery Time after exposure to desflurane or sevoflurane using a standardized wake up|14 Days|Determined if patients passed all eligibility and completed study.||Minutes||Inter-Quartile Range|Median
58598|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients|A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug|First dosing up to 48 months|The safety analysis set defined as all patients who took at least one dose of study drug||Percentage of Patients|||Number
58599|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization|Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment||Percentage of Patients|||Number
58600|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization|Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment||Percentage of Patients|||Number
58601|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization|Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment||Percentage of Patients|||Number
58602|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 7 ([post dose] 24 hours post allergen challenge)|||Percentage||Standard Deviation|Mean
58603|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 6 ([post dose] 7 hours post allergen challenge)|||Percentage||Standard Deviation|Mean
58604|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 5 (post dose)|PD Analysis set||Percentage||Standard Deviation|Mean
58605|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 7 ([post-dose] 24 hours post allergen challenge)|||mg/mL||Full Range|Geometric Mean
58606|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 5 ([post-dose] pre allergen challenge)|||mg/mL||Full Range|Geometric Mean
58607|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 1 (pre-dose)|PD Analysis set||mg/mL||Full Range|Geometric Mean
58608|NCT01225549|Secondary|Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge|AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set||Percentage||Full Range|Geometric Mean
58609|NCT01225549|Secondary|Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge|Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set||Percentage||Full Range|Geometric Mean
58610|NCT01225549|Primary|Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1|LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1|From Randomization to end of treatment|PD Analysis set||Percentage||Full Range|Geometric Mean
58611|NCT01225354|Secondary|Aesthetic Improvement|Subject and Investigator will complete GAIS at Visits 2-4 comparing overall appearance of current visit’s photo to baseline photo|Visit 2-4||||||
58612|NCT01225354|Secondary|Assessment of Malar Deficiency|Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale.|Visit 1-4||||||
58613|NCT01225354|Secondary|Subject First Impression|Each subject will complete the 10-point (1-Not at all to 10-Very Much) evaluating their own first impression at Baseline, Visit 2 (if applicable), Visit 3, and Visit 4.|baseline, Visit 2, Visit3, and Visit 4||12/2013||||
58614|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|2 weeks post optimal cosmetic result|||Participants with improved self-esteem|||Number
59028|NCT01218438|Secondary|Short Term Tolerance - Change in Respiratory Rate||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
58616|NCT01225354|Primary|Blinded Evaluations of First Impression|Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of each of the 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria.|After the 1-month post optimal correction visit for subject 20||||||
58617|NCT01225289|Secondary|Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)|difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation|first day and after 6 month|||absorbance units||Standard Error|Mean
58618|NCT01225289|Secondary|Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation||first day and after 6 month|||ratio||Standard Error|Mean
58619|NCT01225289|Secondary|Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation||first day and after 6 month|||pg/ml||Standard Error|Mean
58620|NCT01225289|Primary|Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation||first day and after 6 month|||mg/L||Standard Error|Mean
58621|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24||Weeks 13 to 24|||days||Inter-Quartile Range|Median
58622|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12||Weeks 1 to 12|||days||Inter-Quartile Range|Median
58623|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Weight at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||kg||Standard Error|Least Squares Mean
58624|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||kg/m^2||Standard Error|Least Squares Mean
58625|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56|CFQ-R respiratory domain is defined in Outcome Measure 17.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||units on a scale||Standard Error|Least Squares Mean
58626|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||units on a scale||95% Confidence Interval|Least Squares Mean
58627|NCT01225211|Secondary|Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||percent change||Standard Error|Least Squares Mean
58628|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.||percent change||95% Confidence Interval|Least Squares Mean
58629|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
58630|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||percent change||95% Confidence Interval|Least Squares Mean
58631|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
58632|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
58633|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||liters||95% Confidence Interval|Least Squares Mean
58634|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Sweat Chloride at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||Standard Error|Least Squares Mean
58635|NCT01225211|Secondary|Cohort 2 And 3: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 2: Baseline, Day 14|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||95% Confidence Interval|Least Squares Mean
58636|NCT01225211|Secondary|Cohort 1: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 1: Baseline, Day 14|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||95% Confidence Interval|Least Squares Mean
58637|NCT01225211|Primary|Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Hankinson method.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.||percent predicted of FEV1||Standard Error|Least Squares Mean
58638|NCT01225211|Primary|Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56||Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||mmol/L||95% Confidence Interval|Least Squares Mean
58639|NCT01225211|Primary|Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21||Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
58640|NCT01225211|Primary|Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs|AEs and SAEs are defined in Outcome Measure 1.|Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 4 Safety Set included all participants who received at least 1 dose of study drug in Cohort 4.||participants|||Number
58641|NCT01225211|Primary|Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)|Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56).|Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 2 and 3 Safety Set included all participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.||participants|||Number
58642|NCT01225211|Primary|Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).|Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)|Cohort 1 Safety Set included all participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.||participants|||Number
58643|NCT01225159|Secondary|Morbidities and All Causes Mortality|morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)|within the first 30 days after surgery|||participants|||Number
58644|NCT01225159|Primary|Nosocomial Infection|Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.|within the first 30 day after surgery|||participants|||Number
58645|NCT01225068|Primary|Effect Size of VAS Pain|"Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation.~This is the primary outcome measure."|6 weeks from baseline|per protocol||units on a scale||Standard Deviation|Mean
58646|NCT01225029|Secondary|Time to First Enteral Feed||hour until first enteral feed achieved, an average of approximately 40 hours and a maximum of 100 hours|||hours||Inter-Quartile Range|Mean
58647|NCT01225029|Secondary|Duration of ICU Admission||every day until discharge, an average of approximately 8 days and a maximum of 12 days|||calendar days||Inter-Quartile Range|Mean
58648|NCT01225029|Primary|Duration of Respiratory Support||every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours|||hours||Inter-Quartile Range|Median
58649|NCT01224821|Secondary|Time to Disease Progression or Death for All Participants, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants with disease progression or those who died were analyzed.||months||95% Confidence Interval|Median
58650|NCT01224821|Secondary|Time to Disease Progression or Death for Responders, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants classified as responders with disease progression or those who died were analyzed.||months||95% Confidence Interval|Median
58651|NCT01224821|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants who died during the study were analyzed.||months||95% Confidence Interval|Median
58652|NCT01224821|Secondary|Median Time to Treatment Failure for All Participants|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population||months||95% Confidence Interval|Median
58653|NCT01224821|Secondary|Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.||months||95% Confidence Interval|Median
58654|NCT01224821|Secondary|Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.||months||95% Confidence Interval|Median
58655|NCT01224821|Secondary|Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.||months||95% Confidence Interval|Median
58656|NCT01224821|Secondary|Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.||months||95% Confidence Interval|Median
58657|NCT01224821|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.||months||95% Confidence Interval|Median
58658|NCT01224821|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.||months||95% Confidence Interval|Median
58659|NCT01224821|Secondary|Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed CR and CCR were analyzed.||participants|||Number
58670|NCT01224782|Primary|Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values|Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a > 30% decrease in iPTH compared with the initial values at baseline.||months||Standard Deviation|Mean
58660|NCT01224821|Secondary|Number of Participants With CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
58661|NCT01224821|Secondary|Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
58662|NCT01224821|Secondary|Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
58663|NCT01224821|Secondary|Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)|Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant’s mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001–149999 cells/millimeter cubed (mm^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population||participants|||Number
58664|NCT01224821|Primary|Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites|The dosimetry methods were validated for seven different clinical research sites.|Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U|Intent-to-Treat (ITT) Exposed Population: all participants who enrolled in the study and received at least one dose of study drug. One participant did not receive the therapeutic dose.||participants|||Number
58665|NCT01224782|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.|Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months)|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .||participants|||Number
58666|NCT01224782|Secondary|Mean Weekly Dose of Zemplar (Paricalcitol)|Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).|From Baseline up to 12 months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.||micrograms||Standard Deviation|Mean
58667|NCT01224782|Secondary|Percentage of Participants With Hypercalcemia|The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.|From Baseline up to 12 months|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.||percentage of participants|||Number
58668|NCT01224782|Secondary|Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)|The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.||percentage of participants|||Number
58669|NCT01224782|Primary|Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2|The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.||percentage of participants|||Number
59029|NCT01218438|Secondary|Short Term Tolerance - Change in Heart Rate (Pulse)||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
58671|NCT01224626|Primary|Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.|Baseline to 8 weeks|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.||participants|||Number
58672|NCT01224626|Secondary|Adverse Drug Reactions Unlisted in Japanese Package Insert.|The adverse drug reactions that have not been included in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
58673|NCT01224626|Primary|Number of Participants With Adverse Drug Reactions.|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
58674|NCT01224444|Secondary|Incomplete Adenoma Resection of Small and Large Adenomas|Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).|1 year||||||
58675|NCT01224444|Primary|Percent of Incompletely Resected Adenomatous Polyps|Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.|1 year|||percentage of incomplete resection|Participants|95% Confidence Interval|Number
58676|NCT01224431|Secondary|Heart Rate|patient on Cardiopulmonary monitoring|On average the first hour in the emergency department, at 4 time points during lumbar puncture procedure.||||||
58677|NCT01224431|Secondary|Length of Cry|cry video recorded and measured after needle stick until pt stopped crying|On average the first hour in the emergency department; from needle stick to end of lumbar puncture||||||
58678|NCT01224431|Primary|Pain, Measured as Units on a Scale|Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible|on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.|||units on scale, 0-5||Standard Deviation|Mean
58679|NCT01224236|Secondary|Transfusions|# of transfusions infants required after enrollment.|enrollment to 36 weeks postmenstrual age (PMA)|||transfusions||Inter-Quartile Range|Median
58680|NCT01224236|Primary|Hematocrit (Hct)|For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.|36 weeks postmenstrual age (PMA)|||percentage of red blood cells in blood||Standard Deviation|Mean
58681|NCT01224171|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).~Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?"|From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.|Overall Safety Population||participants|||Number
58682|NCT01224171|Secondary|Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation|"Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percent deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|TNFα Antagonist Failure ITT Subpopulation||percentage of participants||95% Confidence Interval|Number
58683|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the Overall Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|Overall ITT population||percentage of participants||95% Confidence Interval|Number
58684|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|TNFα Antagonist Failure ITT Subpopulation||percentage of participants||95% Confidence Interval|Number
58685|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|Overall ITT population||percentage of participants||95% Confidence Interval|Number
58686|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|TNFα Antagonist Failure Intent-to-treat (ITT) Subpopulation||percentage of participants||95% Confidence Interval|Number
58687|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 6 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Overall ITT population, consisting of all randomized participants who received any amount of blinded study drug.||percentage of participants||95% Confidence Interval|Number
58688|NCT01224171|Primary|Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|TNFα Antagonist Failure Intent-to-treat (ITT) subpopulation which consisted of all randomized participants who received any amount of blinded study drug who met the TNFα antagonist failure criterion.||percentage of participants||95% Confidence Interval|Number
58689|NCT01224015|Primary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines|The investigator assessed the severity of the patient's Crow’s Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis.||Percentage of participants|||Number
58690|NCT01223937|Secondary|Minimum Post-Treatment Serum Sodium Levels|Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 up to 3 months|Safety analysis set||participants|||Number
58691|NCT01223937|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug.|Day 1 up to 3 months|Safety analysis set||participants|||Number
58692|NCT01223937|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
58693|NCT01223937|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||mL||Standard Deviation|Mean
58694|NCT01223937|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||minutes||Standard Deviation|Mean
58695|NCT01223937|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||probability|||Number
58696|NCT01223937|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.||nocturnal voids||Standard Deviation|Mean
58697|NCT01223937|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).||probability|||Number
58698|NCT01223937|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).||nocturnal voids||Standard Deviation|Mean
58699|NCT01223703|Secondary|Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.|"NYHA class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs, etc...~NYHA class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.~NYHA class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest NYHA class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|one year|||units on a scale||Standard Deviation|Mean
58700|NCT01223703|Secondary|Functional Capacity (Change in Peak Oxygen Uptake, VO2)|Change in functional capacity expressed as a peak oxygen uptake (VO2), that was acquired breath-by-breath by pneumotachograph (with bidirectional differential pressure) during cardiopulmonary exercize testing.|one year|||ml/kg/min||Standard Deviation|Mean
58701|NCT01223703|Secondary|LV Diastolic Function|Change in LV diastolic function assessed by echocardiography: mitral diastolic inflow velocities (peak velocity of early ventricular filling [E-wave], peak velocity of late ventricular filling [A-wave], E/A ratio, and E-wave deceleration time), diastolic function score (graded on a scale from 1 to 4) were used.|one year|||E/A ratio||Standard Deviation|Mean
58725|NCT01222689|Secondary|Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Tabulation of type of adverse events (AE) and the incidence of grade 3 and 4 for each AE|Up to 30 days after completion of study treatment|||events|||Number
58727|NCT01222689|Secondary|CA19-9 Biomarker Response (Defined as a 50% Decline in Serum CA19-9 Level From Baseline in Patients With > 2 x ULN CA19-9 Measurement)|The proportion of patients with CA19-9 response.|Up to 2 years|Patients with baseline levels > 2 x ULN CA19-9 measurement||percentage of participants|||Number
58702|NCT01223703|Primary|Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up|The primary end point of the study was the change in LV systolic function expressed as LVEF between baseline and 12-month follow-up. The following parameters were measured according to the professional standards defined by the American Society of Echocardiography and the European Association of Echocardiography|one year|A sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with p<0.05 (2-tailed) at the Student t test for unpaired data.||ejection fraction (percentage)||Standard Deviation|Mean
58703|NCT01223469|Primary|Number of Subjects With Operative and Post-operative Serious Adverse Events|"For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer.~For AF patients 3 months (±2 weeks)following the index procedure."|3 months for AF arm; 7 days for the right SVT arm|||participants|||Number
58704|NCT01223196|Other Pre-specified|Percentage (%) of Haemoglobin A1C|HbA1c (Haemoglobin A1c) is glycosylated haemoglobin, measured as a % of total Hb in red blood cells by a standard biochemical method (HPLC).|6 months|||Percentage (%) of HbA1c||Standard Error|Mean
58705|NCT01223196|Secondary|Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle.|The activity of TACE is measured by detecting the release of a fluorogenic synthetic substrate of TACE and measuring in a fluorometer. It is expressed in Fluorescence Units (F.U.)|6 months|These individuals completed both the baseline and all intermediate and the end of study visits.||Tace Activity in F.U./mg prot||Standard Error|Mean
58706|NCT01223196|Primary|Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp|"Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment.~The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins)"|6 months|M/I||Mg. of glucose/kg body w./mUxl ins.||Standard Error|Mean
58707|NCT01223027|Secondary|Pre-dose Concentration in Plasma in Dovitinib|Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.|Week 2 Day 5, Week 4 Day 5, Week 6 Day 5|Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one dose of dovitinib and had at least one evaluable post-Baseline dovitinib concentration measurement.||ng/ml||Standard Deviation|Mean
58708|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
58709|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
58710|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores|The Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).|from date of randomization, at least 2 score units|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
58711|NCT01223027|Secondary|Time to Definitive Worsening of Karnofsky Performance Status (KPS)|Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.|from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier|Full Analysis Set (FAS) consited of all randomized patients.||Months||95% Confidence Interval|Median
58726|NCT01222689|Secondary|Objective Radiographic Response by RECIST Criteria|"Patient's best overall response will be tabulated by level; proportions of complete response (CR) and of CR+partial response will be calculated along with 95% confidence intervals.~Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR, >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR."|Up to 2 years|There were no complete or patial responses by RECIST (stable disease, partial response, or complete response) amongst the 46 participants||participants|||Number
58712|NCT01223027|Secondary|Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review|Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.||Percentage of Participants|||Number
58713|NCT01223027|Secondary|Progression Free Survival (PFS) Per Investigator's Radiology Review|PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
58714|NCT01223027|Secondary|Overall Survival (OS)|Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.|until at least 386 deaths are documented in the clinical database.|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
58715|NCT01223027|Primary|Progression Free Survival (PFS) Per Independent Central Radiology Review|Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.|Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)|Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
58716|NCT01223001|Secondary|Hopkins Verbal Learning Test|To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.|9 months||||||
58717|NCT01223001|Primary|Hamilton Rating Scale for Depression|To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.|9 months|Analysis was not conducted. Study was terminated before interim analysis. Raw data is stored in a secure location, but not able to be accessed.|||||
58718|NCT01222884|Secondary|Change in Hemoglobin Concentration||6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
58719|NCT01222884|Primary|Ability to Maintain Hemoglobin Level|The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis.|Baseline to 6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.||percentage of participants|||Number
58720|NCT01222689|Secondary|Number of Patients With Dose Modifications and Reason for Dose Modification.|Tabulation of the reasons for dose modification with number of patients|Up to final day of study treatment|Numbers in tabulation total to more than 18 because patients often had 2 or more reasons that prompted dose reduction. For example: Nausea/Vomiting + diarrhea (3), fatigue + diarrhea (2), rash + hypertension (1), rash + diarrhea (1), fatigue + Nausea/Vomiting (1)||participants|||Number
58721|NCT01222689|Primary|Survival at 24 Weeks|Percent survival at 24 weeks (6 months)|24 weeks|||percentage of participants|||Number
58722|NCT01222689|Other Pre-specified|Plasma Biomarkers Potentially Predictive of Dual MEK/EGFR Inhibition|"The association between candidate plasma biomarkers of interest, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response.~Specifically, correlation of the relative change in allelic frequency of mutations present in both pre-treatment and on-treatment blood samples versus percent change in CA19-9."|Up to 2 years|Patients who had non-germline mutations (circulating cell-free DNA) represented in both their pre-treatment blood and on-treatment blood samples.||R^2|||Number
58723|NCT01222689|Other Pre-specified|Circulating Tumor Cell (CTC) Analysis|The association between baseline CTC numbers, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response will be evaluated. The association between expression level of protein markers in CTC with biopsy samples using Pearson's correlation and by unsupervised hierarchical clustering of samples using Pearson correlation as the distance metric will be assessed. Association of longitudinal protein markers in CTC with patient OS will be evaluated using the joint models of longitudinal observations.|Up to 2 years|Data was not collected.|||||
58724|NCT01222689|Other Pre-specified|Protein Expression Levels in Pretherapeutic Core Biopsies|Logistic regression models will be used to associate baseline protein markers and best objective response. Cox models will be used to associate baseline protein markers with overall and progression-free survival. Each selected protein markers will be evaluated individually and ranked by the corresponding p-values. Combinations of markers will also be explored.|Up to 2 years|Data was not collected.|||||
58728|NCT01222689|Secondary|Progression-free Survival (PFS)|"Calculated according to the method of Kaplan and Meier. Actual and estimated probability of being alive and progression-free, along with a 95% confidence interval, will be calculated.~Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(Macdonald et al.):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used. Progressive Disease is defined as a 20% or higher increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)."|From first dose of study treatment to the date of objective progression, or death due to cancer or unknown cause, or to the date of withdrawal from the trial from unknown reasons, assessed up to 2 years|||months||95% Confidence Interval|Median
58729|NCT01222689|Primary|Overall Survival (OS)|Survival will be calculated according to the method of Kaplan and Meier. Both actual and estimated probability of being alive (along with a 95% confidence interval) at 24 weeks (6 months) and for any multiple of 6 months will be calculated for which the number of uncensored subjects is not smaller than 10.|Up to 2 years|||months||95% Confidence Interval|Median
58730|NCT01222585|Primary|Volume of Distribution|Volume of Distribution (L/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.||L/kg||Full Range|Median
58731|NCT01222585|Primary|Clearance|Clearance (L/h/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.||L/h/kg||Full Range|Median
58732|NCT01222585|Primary|Multiple Dose Minimum Concentration|Multiple Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.||mg/L||Full Range|Median
58733|NCT01222585|Primary|Multiple Dose Maximum Concentration|Multiple Dose Maximum Concentration (mg/L)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the multiple dose PK parameter.||mg/L||Full Range|Median
58734|NCT01222585|Primary|Loading Dose Minimum Concentration|Loading Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.||mg/L||Full Range|Median
58735|NCT01222585|Primary|Loading Dose Maximum Concentration|Loading Dose Maximum concentration (Cmax)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.||mg/L||Full Range|Median
58736|NCT01222585|Primary|Area Under the Curve at Steady State|Area under the curve at steady state (AUCss)|pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate this PK parameter.||mg*hr/L||Full Range|Median
58737|NCT01222572|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.~DLTs were defined as follows (CTCAE v4.0):~Grade 2 non-hematologic toxicities: Myelitis; Esophageal fistula, perforation, hemorrhage~Grade 3 non-hematologic toxicities considered to be a direct result of therapy:~Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 4 non-hematologic toxicities: Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophagitis (not due to mediastinal irradiation unrelated to the stereotactic boost), esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 5 non-hematologic toxicity: Any"|7-week chemoradiotherapy period and the subsequent 8-week recovery period|All treated participants who received at least one dose of the study drug and were evaluable for DLT.||participants with DLT|||Number
58738|NCT01222533|Other Pre-specified|VPB Singles|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58739|NCT01222533|Other Pre-specified|VPB Pairs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58740|NCT01222533|Other Pre-specified|VPB Runs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58754|NCT01222533|Secondary|FVC at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
58741|NCT01222533|Other Pre-specified|VPB Total|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58742|NCT01222533|Other Pre-specified|SVPB Singles|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58743|NCT01222533|Other Pre-specified|SVPB Pairs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58744|NCT01222533|Other Pre-specified|SVPB Runs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58745|NCT01222533|Other Pre-specified|SVPB Total|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||participants|||Number
58746|NCT01222533|Other Pre-specified|Mean Heart Rate (HR)|"Mean HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)||bpm||Standard Deviation|Mean
58747|NCT01222533|Other Pre-specified|Maximum Heart Rate (HR)|"Maximum HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded).||bpm||Standard Deviation|Mean
58748|NCT01222533|Secondary|Minimum Plasma Concentration at Steady-state (Cmin,ss)|Cmin,ss is the minimum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
58749|NCT01222533|Secondary|Renal Clearance at Steady-state (CL R,0-6h,ss)|Renal clearance of the drug over the time interval 0 to 6 hours at steady-state. CL R,0-6h,ss was calculated as the quotient of Ae0-6h,ss and AUC0-6h,ss.|Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing.|PK Set. All patients with analysable data.||mL/min||Geometric Coefficient of Variation|Geometric Mean
58750|NCT01222533|Secondary|Pre-dose Plasma Concentration at Steady-state (Cpre,ss)|Cpre,ss is the measured concentration of tiotropium in plasma before dosing at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline)|PK Set. All patients with analysable data.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
58751|NCT01222533|Secondary|Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)|Total quantity of the analyte that is excreted in urine over the time interval 0 to 6 hours at steady state.|Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing.|PK Set. All patients with analysable data.||ng||Geometric Coefficient of Variation|Geometric Mean
58752|NCT01222533|Secondary|Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)|Tmax,ss is the time from dosing to the maximum concentration of tiotropium in plasma-venous blood at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.||hours||Full Range|Median
58753|NCT01222533|Secondary|Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)|AUC0-1h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 1 hour post-dose at steady-state. AUC0-1h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
87993|NCT00928720|Secondary|Functional Status Using the Fibromyalgia Index Questionnaire||at baseline and weekly over 8 weeks||||||
58756|NCT01222533|Secondary|FVC AUC0-3h at the End of Each Treatment Period|FVC AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
58757|NCT01222533|Secondary|FVC AUC0-6h at the End of Each Treatment Period|FVC AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
58758|NCT01222533|Secondary|Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period|Defined as the pre-dose FVC measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.||Liter||Standard Error|Mean
58759|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period|FEV1 AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.||Liter||Standard Error|Mean
58760|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period|FEV1 AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.||Liter||Standard Error|Mean
58761|NCT01222533|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period|Defined as FEV1 measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|Full analysis set (FAS) with imputed data. FAS includes all patients in the treated set who have analysable data for at least one efficacy endpoint during the relevant crossover period.||Liter||Standard Error|Mean
58762|NCT01222533|Primary|Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)|AUC0-6h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours post-dose at steady-state. AUC0-6h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. No PK data for Placebo. The low number of non-missing AUC0-6h,ss results for the Tio R 1.25 and Tio R 2.5 cohorts is due to the exclusion of results below the limit of quantification.||pg*h/ml||Geometric Coefficient of Variation|Geometric Mean
58763|NCT01222533|Primary|Maximum Plasma Concentration at Steady-state (Cmax,ss)|Cmax,ss is the maximum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|Pharmacokinetic (PK) Set. This analysis set includes all patients in the treated set who had at least one blood sample drawn or one urine sample collected for PK analysis. Patients with an important protocol violation relevant to the PK population were excluded. No PK data for placebo. All patients with analysable data.||pg/ml||Geometric Coefficient of Variation|Geometric Mean
58764|NCT01222520|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Participants|||Number
58765|NCT01222520|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Percentage of participants|||Number
58766|NCT01222520|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Percentage of participants|||Number
58767|NCT01222520|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP ≥140 mmHg at reference baseline||Percentage of participants|||Number
58768|NCT01222520|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS||Percentage of participants|||Number
58769|NCT01222520|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|FAS||mmHg||Standard Error|Least Squares Mean
58770|NCT01222520|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|Full analysis set (FAS)||mmHg||Standard Error|Least Squares Mean
58771|NCT01222507|Primary|Brain Speed Test|This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.|Initial study visit|The number of subjects who completed the study according to protocol.||units on a scale||95% Confidence Interval|Median
59030|NCT01218438|Secondary|Short Term Tolerance - Change in Blood Pressure||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
58772|NCT01222403|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.|The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.||Number of Subjects|||Number
58773|NCT01222403|Primary|Number of Subjects Reporting Unsolicited AEs After Vaccination.|The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.||Number of Subjects|||Number
58774|NCT01222403|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.|The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 4 after vaccination|Analysis was done on safety population ie. all subjects in the exposed set who provided postvaccination safety data.||Number of Subjects|||Number
58775|NCT01222390|Primary|Breast Projection|The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).|1.5 years|||percentage loss of projection|Participants|Standard Deviation|Mean
58776|NCT01222390|Secondary|Location of Volume Change|3-D photos will be taken to assess the location of volume and contour changes in the breast.|1.5 years||||||
58777|NCT01222390|Secondary|Emotional Outcomes|Emotional outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years||||||
58778|NCT01222390|Secondary|Complication Rate|Complications may include hematoma, seroma, infection, implant migration, inflammation or explantation.|1.5 years||||||
58779|NCT01222390|Secondary|Aesthetic Outcomes|Aesthetic outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years||||||
58780|NCT01222286|Secondary|Secondary Anti-tumor Activity|"any change of M-protein in serum occurring during the study (>25 percentage increase in level of serum M-protein)~progression to active Multiple Myeloma~Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder :~Development of new soft tissue plasmacytomas or bone lesions~Hypercalcemia (> 11mg/100ml)~Decrease in hemoglobin of > 2g/100ml~Rise in serum creatinine by 2 mg/100ml or more"|from start to end of study (14 months)|||Participant|||Number
58781|NCT01222286|Secondary|Pharmacodynamics of IPH2101|biological activity of IPH2101 on KIR occupancy at End of Treatment|from start to end of study (14 months)|all subjects who received at least 1 dose of IPH2101||% of occupancy of killer like receptor||Full Range|Mean
58782|NCT01222286|Secondary|Safety Assessment|adverse events, physical examination and biological changes during the whole clinical trial.|Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months|The safety population included all subjects who received at least 1 dose of IPH2101||Patients with any AE|||Number
58783|NCT01222286|Primary|Rate of Patients Achieving an Objective Response|The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.|from start to end of study (14 months)|The ITT population included all randomized subjects.||participants|||Number
58784|NCT01222234|Primary|Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol||8 weeks of therapy|The primary comparison for this outcome of interest was between subjects taking cholecalciferol, so the calcitriol group (group 2) was excluded from the analysis. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.||ng/ml||Standard Deviation|Mean
58785|NCT01222234|Primary|Monocyte Protein Expression|Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression|8 weeks of therapy|The primary comparison for this outcome was between only CKD groups (groups 1 and 2); therefore data from the non-CKD group (group 3) was not analyzed for this outcome. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.||relative fluorescence units||Standard Deviation|Mean
58786|NCT01222195|Primary|Number of Patients With a Transfusion Independence Response|Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.|Over six 28-day cycles (approximately 168 days)|Analysis was per protocol.||participants|||Number
58787|NCT01222117|Secondary|The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.|The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.|30 days|Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)||percentage of participants|||Number
58788|NCT01222117|Primary|The Proportion of Subjects With >50% Thrombolysis|The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography.|5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)|In groups A-D, G and H, 8 subjects were excluded (EOT arteriogram missing or not read, did not receive >=90% of dose). In groups I and J, 11 subjects were excluded (BOC not inserted/appropriately inflated, missing an arteriogram). In group F, 1 subject was not dosed and 4 subjects were excluded (did not receive >=90% of dose).||percentage of participants|||Number
58789|NCT01222104|Secondary|Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.|30 days|||% of procedures with minor vasc comp.|Participants||Number
58797|NCT01222104|Secondary|Rate of Minor Vascular Complications|"The following are defined as a minor vascular complication:~Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;~Ipsilateral hematoma >10 cm;~Ipsilateral pseudoaneurysm without intervention;~Ipsilateral arteriovenous fistula;~Ipsilateral deep vein thrombosis;~Local access site infection without prolonged hospitalization"|30 days|||% of procedures with minor vasc comp.|Participants||Number
58798|NCT01222104|Secondary|Time to Hemostasis|Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required.|Procedure|||% of procedures|Participants||Number
58799|NCT01222104|Primary|Rate of Major Vascular Complications|"Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.~The following are defined as a major vascular complication:~Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;~Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;~Access site related bleeding requiring transfusion;~New ipsilateral lower extremity ischemia requiring surgical intervention;~Retroperitoneal bleeding;~Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;~Access related complication that results in extended hospital stay;~Death"|30 days|5 subjects underwent vascular closure with Angio-Seal on right and left sides.||Percentage of Procedures|Participants||Number
58800|NCT01221948|Secondary|Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.|Global Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: (“very much improved” to “marked worsening”). This assessment was completed by the neurologist.|52 weeks post first lead implantation|||percentage of participants|||Number
58801|NCT01221948|Primary|Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.~Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|26 weeks post first lead implantation|||units on a scale||Standard Deviation|Mean
58802|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on|The purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients’ ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent).|12, 26 and 52 weeks post first lead implantation|||percentage change||Standard Deviation|Mean
58803|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Parkinson’s Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.|"The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions:~mobility~activities of daily living~emotional well-being~stigma~social support~cognitions~communication~bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure."|12, 26 and 52 weeks post first lead implantation|||percentage change||Standard Deviation|Mean
58804|NCT01221948|Secondary|Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.|Subjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record “on”, “on with troublesome dyskinesia”, “off”, and “asleep” times for three consecutive days.|12, 26 and 52 weeks post first lead implantation|||hours/day||Standard Deviation|Mean
58805|NCT01221948|Secondary|Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation|All parkinsonian medications will be converted to Levodopa dose equivalents (LED)|12, 26 and 52 weeks post first lead implantation|40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52||mg||Standard Deviation|Mean
58806|NCT01221948|Secondary|Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items.~Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52."|12, 26 and 52 weeks post first lead implantation|||units on a scale||Standard Deviation|Mean
58807|NCT01221948|Secondary|Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.~Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|12 and 52 weeks post first lead implantation|||units on a scale||Standard Deviation|Mean
58836|NCT01221597|Secondary|A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease|A responder was defined as a subject who recorded his Peyronie’s disease had either improved in a small but important way, moderately improved, or much improved in overall global assessment question.|Week 52|Efficacy analysis was based on the mITT population.||Number of particpants|||Number
58808|NCT01221753|Secondary|4-y Overall Survival Rate|4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.|Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).|The analysis dataset is comprised of all treated patients. Since all patients have not been followed for survival for 5 years the 4-year rate is provided. All data provided was based on chart review and not from case report forms.||percentage of participants|||Number
58809|NCT01221753|Primary|2-Year Local-Regional Control Rate|2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.|The study was terminated early due to weak accrual. Clinical outcome data were not accessible for results reporting due to the designation of study completed at the institution.|||||
58810|NCT01221727|Secondary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
58811|NCT01221727|Secondary|Summary of Percent Change From Baseline to Day 16 for Serum C-Telopeptide Concentration|This table summarizes percent change from baseline to day 16 for serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.||percentage|Participants|Inter-Quartile Range|Median
58812|NCT01221727|Primary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
58813|NCT01221727|Secondary|Summary of Serum C-Telopeptide Concentration|This table summarizes serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.||ng/mL|Participants|Inter-Quartile Range|Median
58814|NCT01221727|Secondary|Summary of Serum Denosumab Concentration|This table summarizes serum Denosumab for Midazolam with Denosumab group. The Lower Limit Of Quantification (LLOQ) is 20 ng/mL. On Day 2 (pre-dose), the true value is below LLOQ, and is treated as 0 in the analysis.|Baseline (day 2 pre-dose) to day 16|Serum Denosumab will be collected for subjects in Midazolam with Denosumab group only. The analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum Denosumab concentrations are determinable when assessed.||ng/mL|Participants|Standard Deviation|Median
58815|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for PK Cmax Parameter for Midazolam Only Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng/mL|Participants|Standard Deviation|Mean
58816|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam Only Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng*hr/mL|Participants|Standard Deviation|Mean
58817|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for PK Maximum Observed Plasma Concentration (Cmax) Parameter for Midazolam With Denosumab Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng/mL|Participants|Standard Deviation|Mean
58818|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam With Denosumab Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||ng*hr/mL|Participants|Standard Deviation|Mean
58819|NCT01221727|Secondary|Ratio of PK AUC Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
58820|NCT01221727|Primary|Ratio of Pharmcokinetic (PK) Area Under the Concentration Time Curve (AUC) Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.||unitless|Participants|90% Confidence Interval|Least Squares Mean
58821|NCT01221623|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 52|Composite responder analysis is based on the ITT population.||participants|||Number
58822|NCT01221623|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
58823|NCT01221623|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy is based on the mITT population.||centimeters||Standard Deviation|Mean
58824|NCT01221623|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
58825|NCT01221623|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
58826|NCT01221623|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
58827|NCT01221623|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicated a responder.|Week 52|Efficacy is based on the mITT population.||participants|||Number
58828|NCT01221623|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
58829|NCT01221623|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat (mITT) population.||percentage of curvature change||Standard Deviation|Mean
58830|NCT01221597|Secondary|Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score|A responder was defined as a subject who satisfied the following 2 criteria at that visit: a) percent reduction from baseline in curvature deformity was ≥20% and b) reduction from baseline in PDQ Peyronie’s disease bother score was ≥1, or had a change from reporting no sexual activity at screening to reporting sexual activity.|Week 52|Efficacy analysis is based on the mITT population.||Number of participants|||Number
58831|NCT01221597|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population. This population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.||units on a scale||Standard Deviation|Mean
58832|NCT01221597|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||centimeters||Standard Deviation|Mean
58833|NCT01221597|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||units on a scale||Standard Deviation|Mean
58834|NCT01221597|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||units on a scale||Standard Deviation|Mean
58835|NCT01221597|Secondary|Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.||units on a scale||Standard Deviation|Mean
58837|NCT01221597|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.||units on a scale||Standard Deviation|Mean
58838|NCT01221597|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat population (mITT).||percentage of curvature change||Standard Deviation|Mean
58839|NCT01221441|Secondary|Change in SF-36 General Health Assessment Questionnaire (Overall Score) From Baseline to 2 Years|Overall assessment of general health as determined by scoring use an SF-36 Questionnaire (Range 0-100 with higher scores better - indicating less disability)|2 Years|Patients with completed SF-36 questionnaire at 104 weeks||scores on a scale||95% Confidence Interval|Least Squares Mean
58840|NCT01221441|Secondary|Number of Participants With Adverse Events Due to Clinically Significant Changes in Hematology and Urinalysis Tests|The number of participants with changes in clinical hematology, chemistry, and urinalysis test results through 2 years that were considered Adverse Events|2 Years|All patients||participants|||Number
58841|NCT01221441|Secondary|The Incidence and Severity of Adverse Events in Treated Patients|The incidence and severity of adverse events assessed through 104 weeks (2 years) after dose administration|2 Years|All patients receiving treatment with either active or placebo||participants|||Number
58842|NCT01221441|Secondary|The Number of Patients Experiencing Injection Site Reactions Related to Treatment|The number of patients with observations of the administration site deemed related to treatment with either active or placebo, including arthralgia, swelling, irritation, pain, stiffness or abnormalities|2 Years|All participants receiving placebo or active treatment||participants|||Number
58843|NCT01221441|Secondary|The Incidence of Total Knee Arthroplasty|Quantification of the incidence of total knee arthroplasty of the treated knee subsequent to treatment with TissueGene-C|2 Years|All patients that participated in the study||participants|||Number
58844|NCT01221441|Secondary|Change From Baseline in Knee Function as Determined by the Lower Extremity Functional Scale at 2 Years|Assessment of knee function as determined by the Lower Extremity Functional Scale (LEFS); change from baseline to 2 years (Range 0-80 with higher scores signifying lower difficulty in performing knee functions)|2 Years|Patients that completed 2-year follow-up||scores on a scale||95% Confidence Interval|Least Squares Mean
58845|NCT01221441|Secondary|Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia|The number of participants that had a change in pain severity as measured by the incidence and dose of analgesic medications|2 Years|Patients taking at least one analgesia medication||participants|||Number
58846|NCT01221441|Secondary|Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire|Change in pain severity (on a scale from 1 to 4) from baseline to 2 years as measured by a questionnaire (lower scores better)|2 Years|Patients that completed 2 year follow-up||scores on a scale||Standard Deviation|Mean
58847|NCT01221441|Secondary|Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year|Comparison of pre-procedure 3T MRI scans to those obtained at months 12 following dose administration by an independent radiographic reviewer. Evaluations will be scored using Whole Organ Magnetic Resonance imaging Score (WORMS) Cartilage Morphology Subscore (Range 0-6, with higher scores being worse)|1 Year|Patients with available baseline and 1-year MRIs||scores on a scale||95% Confidence Interval|Least Squares Mean
58848|NCT01221441|Secondary|Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years|Measurement to assess outcomes of various chondral disorders of the knee determined by the Lysholm Knee Scale (Range 0-100 with higher scores better). Linear mixed model used for analysis.|2 Years|||scores on a scale||95% Confidence Interval|Least Squares Mean
58849|NCT01221441|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years|Symptoms, pain and functionality of the knee joint as determined by Total Score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (Range 0-100 with higher scores indicating healthier outcomes). Linear mixed model used for analysis.|2 Years|||scores on a scale||95% Confidence Interval|Least Squares Mean
58850|NCT01221441|Primary|Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year|Reduction in pain as measured by a 100 mm visual analog scale (0= no pain; 100 = extreme pain) from Baseline to 1 Year. Linear mixed model used for analysis.|1 Year|Patients with available baseline and 1 year VAS score||units on a scale||95% Confidence Interval|Least Squares Mean
58851|NCT01221441|Primary|Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year|Symptoms, pain and function of the knee joint determined and scored using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation (Total Score, range 0-100 with higher scores better). Linear mixed model used for analysis.|1 Year|Patients with available baseline IKDC scores||scores on a scale||95% Confidence Interval|Least Squares Mean
58852|NCT01221363|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.|Blood samples are drawn at inclusion and at 6 months follow-up. Change in measured HDL (mmol/L) from baseline to 6 months follow-up|Change in measured HDL from baseline and 6 months follow-up|||mmol/Liter||Standard Deviation|Mean
58853|NCT01221363|Primary|Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up|"Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time.~Change in sitting time from baseline to 6 months follow up was evaluated."|7 days of measurement / change in sitting time from baseline and 6 months follow-up|Within group difference||Hours per day||Standard Deviation|Mean
58878|NCT01221298|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4 through Week 12|For the percentage of subjects with HCV RNA suppressed below the LLOQ from Week 4 through Week 12 out of all subjects dosed, it was assumed that if 60% of subjects were successfully suppressed from Week 4 through Week 12 then 20 subjects would give a 95% two-sided confidence interval of (36.1%, 80.9%) using binomial exact methods.||percentage of participants|||Number
58854|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|60 days|||units on a scale||Standard Deviation|Mean
58855|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|Baseline|||units on a scale||Standard Deviation|Mean
58856|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|60 days|||units on a scale||Standard Deviation|Mean
58857|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|Baseline|||units on a scale||Standard Deviation|Mean
58858|NCT01221350|Secondary|Inflammatory IL-4 Sputum Levels at Endpoint|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of IgE in B cells. IL-4 was measured by ELISA.|60 days|||pg/mL||Standard Deviation|Mean
58859|NCT01221350|Secondary|Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of immunoglobulin E (IgE) in B cells. IL-4 was measured by ELISA.|Baseline|||pg/mL||Standard Deviation|Mean
58860|NCT01221350|Secondary|Induced Sputum Eosinophils at Endpoint|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|60 days|||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
58861|NCT01221350|Secondary|Induced Sputum Eosinophils at Baseline|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|Baseline|||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
58862|NCT01221350|Primary|Spirometric FEF Values at Endpoint|Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|60 days|||Liters/sec||Standard Deviation|Mean
58863|NCT01221350|Primary|Spirometric FEF Values at Baseline|Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|Baseline|||Liters/sec||Standard Deviation|Mean
58864|NCT01221350|Primary|Spirometric FEV1 Values at Endpoint|Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|60 days|||Liters||Standard Deviation|Mean
58865|NCT01221350|Primary|Spirometric FEV1 Values at Baseline|Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|Baseline|||Liters||Standard Deviation|Mean
58879|NCT01221285|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants were analyzed to determine if treatment inhibits the in-vitro cockroach antigen binding to B-cells after 6-months of treatment with cockroach SCIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Percent antibody binding||Standard Error|Mean
67535|NCT01132690|Secondary|Chemokine (C-C Motif) Ligand 18 (CCL18)|Percent change from baseline in CCL18|Every 3 months for 12 months|||Percent Change from Baseline||Standard Deviation|Mean
58866|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Endpoint|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products.|60 days|||nmol/mg||Standard Deviation|Mean
58867|NCT01221350|Primary|Spirometric FVC Values at Endpoint|Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|60 days|Per protocol||Liters||Standard Deviation|Mean
58868|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Baseline|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products|Baseline|||nmol/mg||Standard Deviation|Mean
58869|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint|Change in the induced sputum of antioxidant parameters GSH and GSSG levels after 60 days of treatment. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|60 days|||ratio||95% Confidence Interval|Mean
58870|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline|Induced sputum of GSH and GSSG levels at baseline. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|Baseline|||ratio||95% Confidence Interval|Mean
58871|NCT01221350|Primary|Spirometric FVC Values at Baseline|Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|Baseline|||Liters||Standard Deviation|Mean
58872|NCT01221298|Secondary|Time to Virologic Relapse Through 24 Weeks Post-treatment|Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.||Days||95% Confidence Interval|Mean
58873|NCT01221298|Secondary|Time to Failure to Suppress or Rebound During Treatment|The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).||Days||Standard Error|Mean
58874|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
58875|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
58876|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
58877|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.||percentage of participants|||Number
58880|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. Numerator is geometric mean post-baseline IgG4; denominator is baseline IgG4. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Number
58881|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Number
58882|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. Numerator is geometric mean post-baseline IgE; denominator is baseline IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Number
58883|NCT01221285|Primary|Number of Reported Treatment-related Serious Adverse Events (SAEs)|Number of SAEs reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat||Events|||Number
58884|NCT01221285|Primary|Number of Reported Treatment-related Adverse Events (AEs)|Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat||Events|||Number
58885|NCT01221272|Secondary|Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible TPD was derived as the exercise TPD at baseline and at the end of Periods 1 and 2 minus the resting TPD at baseline. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set||units on a scale||Standard Error|Mean
58886|NCT01221272|Secondary|Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible PDS was derived as the exercise PDS at baseline and at the end of Periods 1 and 2 minus the resting PDS at baseline. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set||percentage of myocardium||Standard Error|Mean
58887|NCT01221272|Secondary|Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2|Perfusion defect severity was assessed for each participant as the percentage of the 17 myocardium segments with a relative perfusion defect score of 3 or 4 on a 0-4 scale. Segment scores are: 0 = normal perfusion; 1 = mild reduction in counts-not definitely abnormal; 2 = moderate reduction in counts-definitely abnormal; 3 = severe reduction in counts; 4 = absent uptake (lower scores correspond to less severity and higher scores correspond to increased severity). A lower percentage means fewer segments have severely reduced blood flow. Measurements were obtained by SPECT imaging following exercise at baseline and at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set||percentage of segments||Standard Error|Mean
58888|NCT01221272|Primary|Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment|TPD is a score that measures the overall impact of a region of decreased myocardial blood flow, incorporating both the amount and severity of the decreased flow. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set||units on a scale||Standard Error|Least Squares Mean
58889|NCT01221272|Primary|Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment|PDS is the amount (percent) of the myocardium with decreased blood flow. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by gated single photon emission computed tomography (SPECT) imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set: 61 randomized and treated participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software||percentage of myocardium||Standard Error|Least Squares Mean
58890|NCT01221090|Secondary|Quality of Life (QOL)|Participants where asked the number of days in the past 30 days in which their physical (phys) and/or mental was not good, and whether their usual activity was affected by their physical/mental health.|12 months|Participants were included if they completed the 12-mo follow-up questionnaire. They also had to have answered questions pertaining to quality of life. Missing responses were not included.||Number of days||Standard Deviation|Mean
58891|NCT01221090|Secondary|Diabetes-related Behaviors|Participants were asked the number of days in the past 7 which they participated in various diabetes self-care activities on diet, exercise, home blood glucose monitoring, and foot care.|12 months|Those who completed a questionnaire at baseline and at their 12-month visit were included. Also, they had to have answered questions regarding self-care activities on both surveys since the calculated mean was the average difference in days within the past 7 that individuals participated in self-care activities between 12-months and baseline.||Days (e.g., Avg diff 12mo vs baseline)||Standard Deviation|Mean
58892|NCT01221090|Secondary|Patient Self-reported Perceived Health Status||12 months|Perceived health status was collected using a questionnaire administered during the 12-month follow-up visit. Individuals who did not complete the questionnaire during the follow-up visit or who refused to answer the question were not included in the analysis.||participants|||Number
58893|NCT01221090|Secondary|BMI|Body mass index|12 months|BMI was computed from height & weight measurements from the 12-month follow-up (f/u) visit. Those unable to come in had height and weight abstracted from their EHRs. Measures recorded fell within the range of 10 days prior to and 45 days after participants’ f/u visit dates. Those missing this information was not included in the analysis.||kg/m^2||Standard Deviation|Mean
58907|NCT01220557|Secondary|Treatment Satisfaction / Problem Areas in Dealing With Diabetes|Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.|6 Month Follow up||||||
58908|NCT01220557|Secondary|Diabetes Self-Efficacy Scale|A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.|6 Month Follow up||||||
58894|NCT01221090|Primary|HbA1c|Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation.|12 months|A participant was included in the analysis if he/she had a HbA1c value collected. A longitudinal analysis was performed, with participants contributing one or more HbA1c values to the model. As such, all participants had at least one HbA1c value and were therefore included in the model.||percentage of gycosylated HbA1c|Participants|Standard Deviation|Mean
58895|NCT01220869|Secondary|Cumulative Probability of no PSA Failure|The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.|Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.||Percentage of participants||95% Confidence Interval|Mean
58896|NCT01220869|Other Pre-specified|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis.|From Day 28 to Day 168|The PP analysis set included all participants from the FAS analysis set without major protocol violations.||Percentage of participants||95% Confidence Interval|Mean
58897|NCT01220869|Secondary|Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28|Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28|From Day 0 to Day 28|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset||Percentage change of PSA||Inter-Quartile Range|Median
58898|NCT01220869|Secondary|Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3|Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3|Day 3|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset||Percentage of participants||95% Confidence Interval|Mean
58899|NCT01220869|Primary|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood’s formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.|From Day 28 to Day 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.||Percentage of participants||95% Confidence Interval|Mean
58900|NCT01220739|Primary|Percentage of Participants With Modified Rankin Scale (0 - 1)|Measures the degree of disability or dependence in the daily activities. Minimum score = 0 (best outcome - No symptoms); Maximum Score = 6 (worse outcome - dead)|90 Days from Stroke Onset|||percentage of participants|||Number
58901|NCT01220739|Primary|Symptomatic Intracranial Hemorrhages||36 hours from tPA initiation|||participants|||Number
58902|NCT01220609|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients.||months||95% Confidence Interval|Median
58903|NCT01220609|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and treated patients||months||95% Confidence Interval|Median
58904|NCT01220609|Primary|Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0||Every cycle until completion of study treatment up to 30 days after stopping study treatment||||||
58905|NCT01220609|Primary|Tumor Response|Complete and Partial Tumor Response as assessed by RECIST 1.1|Every other cycle for the first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
58906|NCT01220557|Secondary|Evaluation of the Diabetes Education Course|Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).|6 month Follow up||||||
66550|NCT01144052|Secondary|Severity of Relapses|Change of Expanded Disability Status Scale (EDSS 1-10). Higher values represent a worser outcome.|12 months vs baseline|||units on a scale||Full Range|Median
58910|NCT01220557|Secondary|Diabetes Distress Scale (DDS)|Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.|6 month follow up||||||
58911|NCT01220557|Secondary|Summary of Diabetes Self-Care Activities (SDSCA)|The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.|6 month||||||
58912|NCT01220557|Secondary|Diabetes Empowerment Score (DES)|Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.|6 month follow up||||||
58913|NCT01220557|Secondary|Hypoglycaemia Awareness Score|The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.|6 month||||||
58914|NCT01220557|Secondary|Diabetes Knowledge|To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.|6 month||||||
58915|NCT01220557|Primary|Changes in Glycemic Control Measured by A1c|Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.|6 month|||Changes in A1c in percentage points||Standard Deviation|Mean
58916|NCT01220466|Other Pre-specified|Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction|Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.|6 Months|Percentage of eyes with induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power||percentage of eyes|Participants|95% Confidence Interval|Number
58917|NCT01220466|Other Pre-specified|Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40||6 Months|Percentage of eyes with BSCVA worse than 20/40||percentage of eyes|Participants|95% Confidence Interval|Number
58918|NCT01220466|Other Pre-specified|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|Percent of eyes that lost more than 2 lines of BSCVA.||percentage of eyes|Participants|95% Confidence Interval|Number
58919|NCT01220466|Other Pre-specified|Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D||6 months|Percent of eyes that achieved manifest refraction spherical equivalent within 1.0 D||percentage of eyes|Participants|95% Confidence Interval|Number
58920|NCT01220466|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.||6 months|UCVA is reported as percentage of eyes not percentage of subjects achieving UCVA of 20/40 or better||percentage of eyes|Participants|95% Confidence Interval|Number
58921|NCT01220401|Primary|Past Week Nightmare Frequency|This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).|pre, one week, two months|||nightmares/week||Standard Deviation|Mean
58922|NCT01220401|Secondary|Beck Depression Inventory|This 21-item, self-report measure was designed to assess the severity of depression among adults. Responses on a Likert-type scale range from 0 – 3, and scores may be summed to derive a total score (0-63), with higher scores indicating more depressive symptoms. Scores of 18 and above have been suggested to reliably identify depressed patients.|Baseline, 1 week, 2 months|||units on a scale||Standard Deviation|Mean
58923|NCT01220401|Primary|Clinician Administered PTSD Scale|"This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 – 4). This study utilized the “FI/I2” rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis.~Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD."|pre, one week, two months|||units on a scale||Standard Deviation|Mean
58924|NCT01220401|Primary|Number of Nights With Nightmares|This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).|pre, one week, two months|||nights/week||Standard Deviation|Mean
58925|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Participants|||Number
58926|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Participants|||Number
58927|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Participants|||Number
66551|NCT01144052|Secondary|Proportion of Relapse Free Patients||12 months|||participants|||Number
66552|NCT01144052|Secondary|Number of Relapses||12 months|||number of events|||Number
58928|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Participants|||Number
58929|NCT01220180|Secondary|Number of Participants With PGIC Scale for NeP in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Participants|||Number
58930|NCT01220180|Secondary|Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Participants|||Number
58931|NCT01220180|Secondary|Number of Participants With CGIC Scale for NeP in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Participants|||Number
58932|NCT01220180|Secondary|Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Participants|||Number
58933|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
58934|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
58935|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
58936|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6|Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
58937|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
58938|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.||Units on a scale||Standard Deviation|Mean
58939|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
58940|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6|Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.||Units on a scale||Standard Deviation|Mean
66553|NCT01144052|Secondary|Number of Participants With Relapses||12 months|All enrolled and randomized patients were analyzed.||participants|||Number
58941|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in PP Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.||Percentage of participants|||Number
58942|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in ITT Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.||Percentage of participants|||Number
58943|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.||Percentage of participants||95% Confidence Interval|Number
58944|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.||Percentage of participants||95% Confidence Interval|Number
58945|NCT01219985|Secondary|Lesions Uptake Measurement (SUVmax)|For each detected uptake (in Ungated or CT-based PET images), observers have to report the corresponding maximum standardized uptake value (SUVmax). The SUVmax was obtained automatically in a volume of interest encompassing the entire lesion.|Day 1|The number of participant has been determined on the basis of the annual possible recruitment in the institution to keep the study feasible.||g/L||Standard Deviation|Mean
58946|NCT01219985|Primary|Number of Detected Uptakes on PET Images|Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).|day 1|Patients who underwent liver resection||number of real metastatic lesions|||Number
58947|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
58948|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
58949|NCT01219933|Secondary|CDAI Score During the Interventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58950|NCT01219933|Secondary|SF-36 Subscale Scores During the Interventional Phase|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|ITT Population; n=number of participants analyzed for the given parameter at the specified time point.||units on a scale||Standard Deviation|Mean
58951|NCT01219933|Secondary|Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58965|NCT01219933|Secondary|Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase|The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events.|V1 and V2 (up to 6 months after V1)|Safety Obs Population||participants|||Number
58966|NCT01219933|Secondary|Median Dose of Tocilizumab During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population||mg/kg||Full Range|Median
58952|NCT01219933|Primary|Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks|The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)|Intent-to-Treat (ITT) population: all participants included in the interventional GC reduction phase of the study.||percentage of participants||95% Confidence Interval|Number
58953|NCT01219933|Primary|Type of GC Taken at the End of the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint||percentage of participants|||Number
58954|NCT01219933|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (with the exception of 2 negatively stated), the greater the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58955|NCT01219933|Secondary|SJC and TJC During the Interventional Phase|TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.||joints||Standard Deviation|Mean
58956|NCT01219933|Secondary|VAS for Pain (VAS-Pain) During the Interventional Phase|Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.||mm||Standard Deviation|Mean
58957|NCT01219933|Secondary|VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase|Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.||mm||Standard Deviation|Mean
58958|NCT01219933|Secondary|HAQ-DI During the Interventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined.|Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58959|NCT01219933|Secondary|DAS28-CRP During the Interventional Phase|DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58960|NCT01219933|Secondary|Time-Averaged GC Dose Changes During the Interventional Phase|"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:~AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]~With Di=dosage at time Ti~It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9."|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; only participants who completed the study were included in the analysis.||mg||Standard Deviation|Mean
58961|NCT01219933|Secondary|Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; pnly those participants who completed the study at V9 were included in analysis.||percentage of participants||95% Confidence Interval|Number
58962|NCT01219933|Secondary|Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; only those participants who completed the study at V9 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
58963|NCT01219933|Secondary|Percentage of Participants Able to Start the GC Reduction Phase at V3|All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC.|V3 (7 months)|Safety Int (intervention) run-in: all participants eligible to enter the interventional phase at V2 and who had taken at least 1 dose of MP.||percentage of participants||95% Confidence Interval|Number
67536|NCT01132690|Secondary|Platelet Count|Mean and standard deviation of platelet count per cubic mm|Baseline and 12 months|||platelets per cubic mm||Standard Deviation|Mean
58967|NCT01219933|Secondary|Median Time Interval Between V1 and V2|The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months.|V1 and V2 (up to 6 months after V1)|Safety Obs Population||months||Full Range|Median
58968|NCT01219933|Secondary|Clinical Disease Activity Index (CDAI) During the Noninterventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58969|NCT01219933|Secondary|DAS28-ESR During the Noninterventional Phase|DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58970|NCT01219933|Secondary|DAS28-CRP During the Noninterventional Phase|DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58971|NCT01219933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
58972|NCT01219933|Secondary|Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase|Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
58973|NCT01219933|Secondary|Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
58974|NCT01219933|Secondary|Number of Erosions During the NonInterventional Phase|In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||erosions||Standard Deviation|Mean
58975|NCT01219933|Secondary|Percentage of Participants With Erosions During the NonInterventional Phase|In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
58976|NCT01219933|Secondary|Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission.|V1 and V2 (up to 6 months after V1)|Safety Obs population||percentage of participants|||Number
58977|NCT01219933|Secondary|Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA.|V1 and V2 (up to 6 months after V1)|Safety Obs Population||percentage of participants|||Number
58978|NCT01219933|Primary|Number of Participants With GC Switches During the Noninterventional Phase|During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint||participants|||Number
58979|NCT01219933|Primary|Median GC Dose Taken During the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents.|V1 and V2 (up to 6 months after V1)|Safety obs population; n (number) equals (=) number of participants analyzed for a given parameter at a specified timepoint||mg||Full Range|Median
58984|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6|Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population||participants|||Number
58985|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6|Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol||participants|||Number
58986|NCT01219855|Secondary|Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population|Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.|Baseline to End of Treatment (6 weeks)|Per protocol population||percentage of change from baseline||Standard Deviation|Mean
58987|NCT01219855|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D at Week 6|Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population||ng/mL||Standard Deviation|Mean
58988|NCT01219855|Primary|Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)|Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.|6 weeks|Per protocol||percentage of change from baseline||Standard Deviation|Mean
58989|NCT01219855|Primary|Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).|The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.|6 weeks|Per protocol||percentage of participants|||Number
58990|NCT01219777|Secondary|Toxicity and Response Rates Based on Imaging and Surgical Outcomes|Determine the safety/toxicity of this regimen in this patient population. Estimate the percent of patients undergoing successful cytoreductive surgery to optimal disease (<1 cm greatest tumor diameter) following neoadjuvant chemotherapy with carboplatin, paclitaxel and bevacizumab in patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Assess the 30 day morbidity and mortality following surgical intervention. To describe the response rate for patients treated with neoadjuvant carboplatin, weekly paclitaxel, and bevacizumab using RECIST and GCIG response criteria prior to surgical intervention. Response was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|||patients|||Number
58991|NCT01219777|Primary|Tolerated Dose|To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.|Up to 6 months|||mg/m^2|||Number
58992|NCT01219738|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participant will be followed up to 6 hours after budesonide dose|||percentage of change from baseline||Standard Error|Mean
58993|NCT01219738|Primary|Airway Blood Flow (Qaw)|Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participants will be followed for 6 hours after budesonide dose|||percentage of change from baseline||Standard Error|Mean
58994|NCT01219673|Primary|Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)|Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|10 weeks|No analysis was completed. Study terminated with low enrollment.|||||
58995|NCT01218997|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study|A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.|up to 1 year|All subjects who received at least 1 dose of study drug are included in the safety population.||Participants|||Number
58996|NCT01218984|Primary|Slope Change From Baseline for Pupil Size|Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.|4 weeks (Baseline to Day 28)|Placebo hydromorphone challenge sessions were excluded from the analysis. Results for subjects who discontinued prior to Day 28 were not imputed.||cm(2)/hr||Standard Deviation|Mean
58997|NCT01218971|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 48 weeks (13 injections), not including base study|All participants who received at least 1 dose of study drug are included in the safety population.||Participants|||Number
67537|NCT01132690|Secondary|Spleen Volume|Spleen volume measured by MRI|Baseline and Month 12|||mL||Standard Deviation|Mean
58998|NCT01218958|Secondary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|24 weeks (Baseline to Week 24)|||Participants|||Number
58999|NCT01218958|Primary|Percentage of Heavy Drinking Days Over the Treatment Period|Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.|Baseline through Week 24 (168 days)|The last post-baseline observation carried forward (LOCF) of each participant in the intent-to-treat population (all randomized participants who received at least 1 injection of study drug) were utilized for the primary efficacy analysis.||Percentage of days|Participants|Inter-Quartile Range|Median
59000|NCT01218867|Secondary|In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|6 years|This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants.|||||
59001|NCT01218867|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|33 months and 25 days|||participants|||Number
59002|NCT01218867|Primary|Response to Therapy|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|6 years|||participants|||Number
59003|NCT01218802|Primary|Carotid IMT|changes in carotid IMT is a good measure for cardiovascular disease progression|96 weeks|The number of participants who received a final CIMT is less than the number of participants enrolled, due in part to study drop outs and/or invalid data measures.||percentage change||Standard Deviation|Mean
59004|NCT01218802|Primary|Bone Mineral Density (BMD)|Measured by change in bone DEXA from baseline to week 96|96 weeks|The total number of participants who received this outcome who had valid data is less than the total number of enrolled participants, due to drop outs before week 96 and/or invalid testing data from DEXA results.||percentage of change||Standard Deviation|Mean
59005|NCT01218646|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines.|"Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm.~Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity."|Day 0 up to day 21 post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.||Participants|||Number
59006|NCT01218646|Other Pre-specified|Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.||Participants|||Number
59007|NCT01218646|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)"|Day 21 post-vaccination|Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
59008|NCT01218646|Primary|Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 0 and Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
59009|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers."|Day 21 post-vaccination|Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
59095|NCT01218243|Secondary|Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week|Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.||ml/second||Standard Deviation|Mean
59010|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
59011|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population||Participants|||Number
59012|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (<LLOQ or >ULOQ).||Titers||95% Confidence Interval|Geometric Mean
59013|NCT01218594|Primary|Response Rate (RR)|Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).|4 weeks after CCRT|Response rate (RR)include complete response and partial response.||percentage of participants|||Number
59014|NCT01218477|Secondary|Number of Participants With Grade 3-4 Abnormalities on Laboratory Test Results|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria of the National Cancer Institute from 1 (least severe) to 4 (life threatening). ANC (*10^9): Grade 3, <1.0- 0.5; Grade 4, <0.5. Hemoglobin (mmol/L): Grade 3, <4.9-4.0; Grade 4, <4.0. Platelet count (*10^9/L): Grade 3, <50.0-25.0; Grade 4, <25. WBCs (*10^9): Grade 3, <2.0-1.0; Grade 4, <1.0. Hypocalcemia (mmol/L): Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L): Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L): Grade 3, <3.0-2.5; Grade 4, <2.5. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Hypermagnesemia (mg/dL): Grade 3, >1.23-3.30; Grade 4, >3.30. Phosphorus (mmol/L): Grade 3, <0.6-0.3; Grade 4, <0.3. Lipase (*ULN): Grade 3, >2.0-5.0; Grade 4, >5.0.|Day 1 to Week 80|All participants who received at least 1 dose of study drug.||Participants|||Number
59015|NCT01218477|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment and may or may not be related to treatment. SAE=an untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. The following drug-related AEs occurring during the first 28 days of treatment with both agents were considered to be dose-limiting toxicities (DLTs): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite adequate medical intervention; ≥Grade 2 AE not controlled by medical intervention and requiring treatment interruption for >7 days.|Day 1 to Week 80, continuously, with observation for dose-limiting toxicities (DLTs) in Weeks 5-8|All participants who received at least 1 dose of study drug||Participants|||Number
59016|NCT01218477|Secondary|Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|MHR was defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR for CML-Adv criteria: white blood cell count (WBC) ≤upper limit normal; absolute neutrophil count (ANC) ≥1,000/mm^3; platelets ≥100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); basophils <5% in PB; myelocytes + metamyelocytes < 5% in PB; no extramedullary involvement; blasts must be <5%, if bone marrow assessment (BMA) performed. NEL had same criteria, but with lower thresholds for reconstitution of PB counts, as follows: Platelets ≥ 20,000/mm^3 or ANC >500/mm^3. Confirmed MHR obtained if these criteria met and maintained for ≥28 days. CHR for CML-CP criteria WBC ≤10,000/mm^3; platelets <450,000/mm^3; basophils <5% in PB; no blasts or promyelocytes in PB; myelocytes + metamyelocytes <5% in PB; no extramedullary involvement; blasts must be <5% if BMA performed. Confirmed CHR obtained if these criteria met and maintained for ≥28 days. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|Patients without complete hematologic response at dosing start date who received at least 4 weeks of dasatinib and who had at least 1 on-treatment evaluation of both peripheral blood counts and bone marrow cytogenetic response after at least 4 weeks on treatment.||Percentage of participants||95% Confidence Interval|Number
59017|NCT01218477|Secondary|Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|Cytogenetic response (CyR) was based on the proportion of Philadelphia chromosome-positive (Ph+) cells in metaphase analysis of bone marrow. Complete cytogenetic response (CCyR)=0 Ph+ cells; Partial CyR (PCyR)=1 to 35 Ph+ cells; Minor CyCR= 36-65 Ph+ cells; Minimal CyCR= 66-95 Ph+ cells; No response= >96 Ph+ cells. MCyR=CCyR + PCyR. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|All patients without CCyR at dosing start date who received at least 4 weeks of dasatinib and had at least 1 on-treatment cytogenetic evaluation of the bone marrow data after at least 4 weeks on treatment||Percentage of participants||95% Confidence Interval|Number
87994|NCT00928720|Secondary|Perceived Stress Using Numeric Rating Scale and the Daily Stress Inventory||at baseline and weekly over 8 weeks||||||
59018|NCT01218477|Primary|Recommended Phase 2 Dose (RP2D) of BMS-833923 Plus Dasatinib in Chronic Myeloid Leukemia-Chronic Phase|The following drug-related adverse events (AEs) occurring in the first 28 days of treatment were considered dose-limiting toxicities (DLT): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite medical intervention; ≥Grade 2 AE uncontrolled by medical intervention and requiring treatment interruption for >7 days. RP2D was that dose at which ≤1 of 6 patients had a DLT in the first 4 weeks of treatment. If <3 patients were DLT-evaluable, up to 6 additional patients entered the same dose level. Accrual to a dose level closed if 6 patients were enrolled and <3 were DLT-evaluable. If ≥3 patients at a dose level had no DLTs when a new patient enrolled, the dose was escalated to next level. If 1 DLT was observed in <6 patients, ≥6 patients were required; if no additional DLT was observed, the dose was escalated to the next highest level. If ≥2 DLTs were observed in <6 patients, that level exceeded the RP2D, and the dose was deescalated to the next lowest level.|Day 1 to Week 80, with observation for DLT in Weeks 5-8|Participants who were dose-limiting toxicity (DLT)-evaluable (DLT-evaluable=received combination therapy on >21 of 28 days in Weeks 5 through 8 or interrupted treatment for drug-related AEs)||mg|||Number
59019|NCT01218438|Secondary|Life Quality Index - 13 Years and Older|"For the age group 13 years and older the respondent will be the participant.~Each of the four domains has a separate score, each has a different range as follows:~Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
59020|NCT01218438|Secondary|Life Quality Index - 2 to 12 Years Old|"For the age group 2 to 12 years the respondent will be a parent.~Each of the four domains has a separate score, each has a different range as follows:~Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
59021|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older|"TSQM; for the age group 13 years and older the observer will be the participant.~Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.~The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
59022|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old|"TSQM; for the age group 2 to 12 years the observer will be a parent.~Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.~The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points||Score on a scale||95% Confidence Interval|Median
59023|NCT01218438|Secondary|Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 14 years and older with scores at each respective time point.||Scores on a scale||95% Confidence Interval|Median
59024|NCT01218438|Secondary|Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 8 to 13 with scores at each respective time point.||Score on a scale||95% Confidence Interval|Median
59025|NCT01218438|Secondary|Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set (subset of participants aged 2 to 7 years)||Score on a scale||95% Confidence Interval|Median
59026|NCT01218438|Secondary|Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration|Laboratory tests for confirmation of potential hemolysis include Coomb’s test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.|Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40|Safety Analysis Set||Participants|||Number
59027|NCT01218438|Secondary|Short Term Tolerance - Change in Body Temperature||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||08/2017||||
59031|NCT01218438|Secondary|Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration|"An infusion will be deemed as tolerated unless one of the following occurs:~Any serious related AE(s)~Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion~Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion"|Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of infusions|Infusions||Number
59032|NCT01218438|Secondary|Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of participants|||Number
59033|NCT01218438|Secondary|Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set||Infusions|Infusions||Number
59034|NCT01218438|Secondary|Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)||Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of participants|||Number
59035|NCT01218438|Secondary|Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)|The number of infusions associated with local non-SAEs divided by the total number of infusions.|Up to 20 months (throughout entire study)|Safety Analysis Set||Percent of infusions|Infusions||Number
59036|NCT01218438|Secondary|Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion|"The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion (temporally associated) plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug(related), divided by the total number of infusions"|Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs|Safety Analysis Set||Adverse events per infusion|Infusions||Number
59037|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions|Within 1 hour of completion of infusion|Safety Analysis Set||Adverse events per infusion|Infusions||Number
59038|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants|Within 1 hour of completion of infusion|Safety Analysis Set||Adverse events per participant|||Number
59039|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions|Within 24 hours of completion of infusion|Safety Analysis Set||Adverse events per infusion|Infusions||Number
59040|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants|Within 24 hours of completion of infusion|Safety Analysis Set||Adverse events per participant|||Number
59041|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions|Within 72 hours of completion of infusion|Safety Analysis Set||Adverse events per infusion|Infusions||Number
59042|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants|Within 72 hours of completion of infusion|Safety Analysis Set||Adverse events per participant|||Number
59043|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion|Number of all SAEs and AEs divided by number of infusions|Up to 20 months per subject (throughout entire study)||08/2017||||
59044|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant|Number of all SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set||Adverse events per participant|||Number
59045|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion|Number of related SAEs and AEs divided by number of subjects and divided by number of infusions|Up to 20 months per subject (throughout entire study)|Safety Analysis Set||Adverse events per infusion|Infusions||Number
59046|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant|Number of related SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set||Adverse events per participant|||Number
59047|NCT01218438|Secondary|Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)|"There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals.~To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured.~The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4.~This was an interim study analysis."|29 weeks|Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4||Correction factor|||Number
59048|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mg/L||95% Confidence Interval|Median
59049|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||Hours (s)||95% Confidence Interval|Geometric Mean
59050|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mg/L||95% Confidence Interval|Geometric Mean
59051|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mL/kg/days||95% Confidence Interval|Geometric Mean
59052|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||(mg*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
59053|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||mg*days/L||95% Confidence Interval|Geometric Mean
59054|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||g/L||95% Confidence Interval|Geometric Mean
59055|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||hours (h)||95% Confidence Interval|Geometric Mean
59056|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||g/L||95% Confidence Interval|Geometric Mean
59057|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time point||mL/kg/days||95% Confidence Interval|Geometric Mean
59058|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||(g*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
59059|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points||g*days/L||95% Confidence Interval|Geometric Mean
59060|NCT01218438|Secondary|Trough Levels of Anti-Hepatitis B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||mIU/mL||95% Confidence Interval|Geometric Mean
59061|NCT01218438|Secondary|Trough Levels of Anti-Haemophilus Influenza B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||mg/L||95% Confidence Interval|Geometric Mean
59062|NCT01218438|Secondary|Trough Levels of Anti-Tetanus Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||IU/mL||95% Confidence Interval|Geometric Mean
59063|NCT01218438|Secondary|Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals||"Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points||g/L||95% Confidence Interval|Geometric Mean
59064|NCT01218438|Secondary|Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)|"IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution;~AUCSC = area under the concentration-time curve following subcutaneous administration;~AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval"|Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18|Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1||Ratio||90% Confidence Interval|Geometric Mean
59065|NCT01218438|Secondary|Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated visits/participant||95% Confidence Interval|Number
59066|NCT01218438|Secondary|Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated days/participant||95% Confidence Interval|Number
59067|NCT01218438|Secondary|Annual Rate of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated hospitalizations/participant||95% Confidence Interval|Number
59068|NCT01218438|Secondary|Annual Rate of Days on Antibiotics Per Participant||1 year|Safety Analysis Set||Estimated days/particpant||95% Confidence Interval|Number
59069|NCT01218438|Secondary|Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant||1 year|Safety Analysis Set||Estimated days off/participant||95% Confidence Interval|Number
59070|NCT01218438|Secondary|Annual Rate of Fever Episodes Per Participant||1 year|Safety Analysis Set||Estimated episodes/year||95% Confidence Interval|Number
59071|NCT01218438|Secondary|Annual Rate of Sinus Infections Per Participant||1 year|Safety Analysis Set||Estimated infections/year||99% Confidence Interval|Number
59072|NCT01218438|Secondary|Annual Rate of All Infections Per Participant||1 year|Safety Analysis Set||Estimated infections/year||95% Confidence Interval|Number
59073|NCT01218438|Primary|Rate of Acute Serious Bacterial Infections Per Year (ASBI)|"Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant.~The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit."|1 year|Safety Analysis Set||Estimated infections/ year|||Number
59074|NCT01218308|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
59075|NCT01218308|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
59076|NCT01218308|Secondary|Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
59077|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||subjects|||Number
59096|NCT01218243|Secondary|Change of Bladder Residual Urine at the 6th Week|Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.||ml||Full Range|Median
63195|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
59078|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
59079|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
59080|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects < 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.||subjects|||Number
59081|NCT01218308|Secondary|Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
59082|NCT01218308|Secondary|Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
59083|NCT01218308|Secondary|Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
59084|NCT01218308|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|On Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
59085|NCT01218308|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||fold increase||95% Confidence Interval|Mean
59097|NCT01218243|Primary|Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population.|baseline and the 6th week|The data analysis of the primary outcome was based on the ITT population(data of all participants who are randomized will be analyzed).||units on a scale||Standard Deviation|Mean
59086|NCT01218308|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||subjects|||Number
59087|NCT01218308|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||subjects|||Number
59088|NCT01218308|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.||titers||95% Confidence Interval|Geometric Mean
59089|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.|To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
59090|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.|To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
59091|NCT01218308|Secondary|Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.|"To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with:~Fever >39°C, and/or at least one of the following manifestations,~Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,~Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis"|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
59092|NCT01218308|Primary|Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.|To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.||subjects|||Number
59093|NCT01218243|Primary|Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population.|baseline and the 6th week|The data analysis of the primary outcome is also based on per-protocol (PP) population as a supportive analysis.||units on a scale||Standard Deviation|Mean
59094|NCT01218243|Secondary|Change of International Prostate Symptom Score (IPSS) at the 18th Week|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean.|baseline and the 18th week|The data analysis of the secondary outcome was based on the ITT population.||units on a scale||Standard Deviation|Mean
87995|NCT00928720|Secondary|Depression Using the CES-D||at baseline and weekly over 8 weeks||||||
59100|NCT01218087|Secondary|Incidence of Cardiorespiratory|daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside|daily up to 120 days|||cardioresp. events/100hrs of device use|||Number
59101|NCT01218087|Primary|Cranial Abnormalities Were Measured at Hospital Discharge|Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.|up to 120 days|||% participant cranial abnormalities|||Number
59102|NCT01218009|Post-Hoc|Pulse at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Heart rate was measured by radial pulse.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population||beats/minute||Standard Deviation|Mean
59103|NCT01218009|Post-Hoc|Blood Pressure at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer was used.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population||mmHg||Standard Deviation|Mean
59104|NCT01218009|Primary|Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator|Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
59105|NCT01218009|Primary|Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator|A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
59106|NCT01218009|Primary|Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator|Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
59107|NCT01218009|Primary|Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator|A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.|||||
59108|NCT01218009|Primary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 49 (study termination)|Safety population||participants|||Number
59109|NCT01217957|Secondary|Phase 2: 1 Year Survival Rate|1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.|1 year after first dose of study drug|||percentage of participants||95% Confidence Interval|Number
59110|NCT01217957|Secondary|Phase 2: Progression Free Survival (PFS)|PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.|Up to 787 days|The mITT population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.||months||95% Confidence Interval|Median
59111|NCT01217957|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|Participants from the Response Evaluable Population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with data available for analysis. Patients who did not experience PD were censored at the last response assessment that was SD or better.||months||95% Confidence Interval|Median
59112|NCT01217957|Secondary|Phase 2: Time to Best Response|Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.|Up to 787 days|Participants form the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.||months||Full Range|Median
59113|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.|Cycles 3, 6, 9 and 12 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
59114|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|After Cycles 3, 6 and 9 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
59115|NCT01217957|Secondary|Phase 2: Overall Response Rate (ORR)|ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
59116|NCT01217957|Secondary|Phase 2: Overall Survival (OS)|OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.|From the first dose of study treatment to the date of death (up to 787 days)|Safety Population included al participants who received 1 of the 3 study drugs. Participants who did not die were censored at the last study visit.||participants||95% Confidence Interval|Median
59117|NCT01217957|Secondary|Phase 2: Time to Progression (TTP)|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).|From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)|The modified Intent-to-Treat (mITT) population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.||months||95% Confidence Interval|Median
59118|NCT01217957|Secondary|Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome|TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory’s performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose||||||
59119|NCT01217957|Secondary|Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome|Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory’s performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose||||||
59120|NCT01217957|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.|Cycle 1, Day 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.||Ratio||Standard Deviation|Geometric Mean
59121|NCT01217957|Secondary|Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.||hr*ng/mL||Standard Deviation|Geometric Mean
59122|NCT01217957|Secondary|Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with data available.||hours||Full Range|Median
59255|NCT01216631|Primary|Ultrasound Synovitis Score|reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment|8 weeks|Only one patient was recruited for this study due to problems with recruitment. Therefore outcome measure data is not analysed as only one patient was recruited.|||||
59123|NCT01217957|Secondary|Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib|Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.||ng/mL||Standard Deviation|Geometric Mean
59124|NCT01217957|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.||percentage of participants|||Number
59125|NCT01217957|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone|MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.||mg/m^2|||Number
59126|NCT01217957|Primary|Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone|RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.||mg/m^2|||Number
59127|NCT01217957|Primary|Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone|ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or; 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|Participants from the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.||percentage of participants||95% Confidence Interval|Number
59128|NCT01217957|Primary|Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.||participants|||Number
59129|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period|Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.|Month 3 up to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment.||injections||Standard Deviation|Mean
59130|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period|Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period|Day 1 prior to month 6 and prior to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment||injections||Standard Deviation|Mean
59131|NCT01217944|Secondary|Number of Ranibizumab Injections Received Prior to Month 3|In order to describe exposure to the study drug the number of ejections was evaluated|Day 1 and prior to month 3|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment||injections||Standard Deviation|Mean
59132|NCT01217944|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye|CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient’s fluorescein angiography and color fundus photography images provided by investigators.|Baseline and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
59133|NCT01217944|Secondary|Change From Baseline in Central Retinal Thickness of the Study Eye Over Time|Retinal thickness was measured by Central Reading Center using patient’s Optical Coherence Tomography (OCT) images provided by investigators.|Baseline, Month 3, Month 6 and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Microns||Standard Deviation|Mean
59256|NCT01216410|Secondary|Maternal Hemodynamics|The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively|Intraoperatively|||participants with SBP< 20 % baseline|||Number
59134|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
59135|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
59136|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
59137|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Percentage of Patients|||Number
59138|NCT01217944|Secondary|Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12|Baseline and Month 1 through Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Letters||Standard Deviation|Mean
59139|NCT01217944|Secondary|Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.|Baseline and Month 6|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Letters||Standard Deviation|Mean
59140|NCT01217944|Primary|Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.|Baseline, Month 1 through Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward||Letters||Standard Deviation|Mean
59141|NCT01217892|Secondary|Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.|To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
59142|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||mg/dL||Standard Error|Least Squares Mean
59143|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.|Baseline to Week 1|Full Analysis Set, participants with non-missing baseline and Week 1 values||mg/dL||Standard Error|Least Squares Mean
59144|NCT01217892|Secondary|Adjusted Percent Change in Body Weight|To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||Percent||Standard Error|Least Squares Mean
59145|NCT01217892|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values||Percent||Standard Error|Least Squares Mean
59146|NCT01217840|Secondary|Inflammatory Cytokines||6 months||||||
59147|NCT01217840|Secondary|Blood Pressure||6 months||||||
59148|NCT01217840|Secondary|Glucose Metabolism||6 months||||||
59149|NCT01217840|Secondary|Lipid Profile||6 months||||||
59150|NCT01217840|Primary|25OH Vitamin D||6 months|||ng/mL||Standard Error|Mean
59151|NCT01217827|Primary|Referral for Implantable Cardioverter Defibrillator||6 months|||participants|||Number
59152|NCT01217749|Primary|Safety During Dose-Limiting Toxicity (DLT) Observation Period|Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2|56 days for Group 1 and 28 days for Group 2|||participants who experienced DLT|||Number
59153|NCT01217749|Secondary|Progression Free Survival (PFS) at 12 Months|"Progressive disease for CLL (Hallek) is characterized by ≥1 of the following:~Appearance of any new lesion, eg lymph nodes (> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates~Increase of ≥50%~in longest diameter of any previous site~in hepatomegaly or splenomegaly~in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen~Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir:~Appearance of a new lesion(s) >1.5 cm in any axis, ≥ 50% increase in the SPD of >1 node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis~Lesions PET+ if FDG-avid lymphoma or PET+ before therapy~50% increase from nadir in the SPD of any liver or spleen lesions~New or recurrent BM involvement~Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen"|From first dose of study treatment until disease progression, death, or until 12 months|||percentage of event free participants||95% Confidence Interval|Mean
59154|NCT01217749|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of study treatment to within 30 days of last dose or until study closure|||participants|||Number
59155|NCT01217749|Primary|Percentage of Participants Achieving Response|The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin’s lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.|The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months|||percentage of participants||95% Confidence Interval|Number
59156|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by ANCOVA.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
59157|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by a mixed-effect model for repeated measure.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation and who have data at the noted time point (no missing imputation)||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
59158|NCT01217606|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed using a two-sample t-test.|Baseline, Week 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
59159|NCT01217515|Secondary|Assessment of Adverse Events, Clinical Laboratory Results, Vital Signs and Sensitivity Reactions|Number of subjects with adverse events, abnormal clinical laboratory results, vital signs and occurrence of any local sensitivity reactions. Data are presented where the incidence is greater than or equal to 5%.|8 weeks|||percentage of participants|||Number
59160|NCT01217515|Secondary|Patient's Global Impression of Improvement (PGI-I)|Compared to the way you felt prior to starting the study treatment, how would you now describe your problems related to the anal fissure?” Responses will be measured on a 7-point Likert scale where 1 = substantially worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = substantially improved. Percentage of subjects scoring 5,6 or 7 was assessed.|4 weeks|||percentage of participants|||Number
59257|NCT01216410|Secondary|Satisfaction|1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.|24 h|||participants|||Number
59258|NCT01216410|Secondary|Pruritus||0-24 hrs|||participants|||Number
59161|NCT01217515|Primary|Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation for Week 4 (for the 7 Treatment Days Immediately Preceding the Week 4 Visit).|Change from baseline in average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable.|4 weeks|||units on a scale||Standard Error|Mean
59162|NCT01217476|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
59163|NCT01217476|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Origin After a Maximum of 12 Weeks Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition to Best Local Cares|wound closure is defined as 100% reepithelialization of the target DFU, without exudates.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
59164|NCT01217463|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
59165|NCT01217463|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition|Wound closure is defined as 100% reepithelialization of the target DFU, without exudate.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.||percentage of participants|||Number
59166|NCT01217411|Primary|Response Rate (Complete or Partial Response) (Phase II)|Only participants with measurable disease present at baseline, received at least 6 weeks of therapy, and had disease re-evaluated considered evaluable for response. Complete Response (CR): Disappearance all lesions; Partial Response (PR): =/>50% decrease in sum bidimensional products all lesions reference baseline sum of bidimensional products of all lesions; Progressive Disease (PD): >25% increase in sum bidimensional products of lesions, or progression of any treated lesion not target lesion, or appearance of 1 or > new lesions at least 6 mm in unidimensional size. Stable Disease (SD): Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum of bidimensional products of all lesions.|12 weeks||||||
59167|NCT01217411|Primary|MTD of RO4929097 in Combination With Stereotactic Surgery (SRS)|MTD of RO4929097 in combination with SRS, determined according to incidence of DLT graded using the NCI CTCAE version 4.0 (phase I)|4 weeks|Analysis was not available due to small number of patients on the study.|||||
59168|NCT01217411|Primary|Maximum-tolerated Dose (MTD) of RO4929097 in Combination With Whole-brain Radiotherapy (WBRT)|Maximum-tolerated dose (MTD) of RO4929097 in combination with WBRT, determined according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|4 weeks|Analysis was not available due to small number of patients on the study.|||||
59169|NCT01217229|Secondary|Pharmacodynamic Biomarkers|Blood samples for serum CSF-1, IL-34 and biomarkers of Fms inhibiton and Hodgkin Lymphoma activity will be obtained from subjects and analyzed for changes in activity.|1 year||||||
59170|NCT01217229|Secondary|Progression Free Survival|Subjects will be monitored for disease progression with contrast CT/18FDG-PET scans every two cycles. One cycle is 28 days.|1 Year||||||
59171|NCT01217229|Primary|Disease Response Using Cheson Criteria|Subjects will be monitored for response and disease progression with contrast CT/18FDG-PET scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria will be reported via descriptive statistics. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.|1 year|By protocol||Response|||Number
59172|NCT01217112|Secondary|The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment|The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates ‘minimal depression’. A score between 14 and 19 indicates ‘mild depression’. A score between 20 and 28 indicates ‘moderate depression’, and a score between 29 and 63 indicates ‘severe depression’. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.|Baseline (Day 1) and the End of Treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
59173|NCT01217112|Secondary|Adverse Events as a Measure of Patient Safety|The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.|Day 1 - Day 92|All correctly randomised subjects who received at least one dose of study treatment were included and analysed according to the treatment received.||participants|||Number
59174|NCT01217112|Secondary|The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment|Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
59259|NCT01216410|Secondary|Postoperative Nausea and Vomiting (PONV)||0-2h, 2-6h, 6-24h|||participants|||Number
59175|NCT01217112|Secondary|The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment|Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent liver fat||Standard Deviation|Mean
59176|NCT01217112|Secondary|The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment|Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59177|NCT01217112|Secondary|The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment|Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59178|NCT01217112|Secondary|The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment|Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59179|NCT01217112|Secondary|The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment|Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59180|NCT01217112|Secondary|The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59181|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59182|NCT01217112|Secondary|The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59183|NCT01217112|Secondary|The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59184|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59185|NCT01217112|Secondary|The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment|Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||litres||Standard Deviation|Mean
59186|NCT01217112|Secondary|The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment|Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||cm||Standard Deviation|Mean
59260|NCT01216410|Primary|Intraoperative Nausea and Vomiting|Comparison of intraoperative nausea and vomiting between the 3 groups.|Intraoperatively|||participants|||Number
59187|NCT01217112|Secondary|The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment|Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||cm||Standard Deviation|Mean
59188|NCT01217112|Secondary|The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment|Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||kg||Standard Deviation|Mean
59189|NCT01217112|Secondary|The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment|Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
59190|NCT01217112|Secondary|The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment|Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||kg/m^2||Standard Deviation|Mean
59191|NCT01217112|Secondary|The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent beta function||Standard Deviation|Mean
59192|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent sensitivity||Standard Deviation|Mean
59193|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||IR score||Standard Deviation|Mean
59194|NCT01217112|Secondary|The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||nmol/l||Standard Deviation|Mean
59195|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||pmol/l||Standard Deviation|Mean
59196|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)|At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||pmol/l||Standard Deviation|Mean
59197|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])|A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59198|NCT01217112|Secondary|The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||percent||Standard Deviation|Mean
59199|NCT01217112|Secondary|The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||umol/l||Standard Deviation|Mean
59200|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59201|NCT01217112|Secondary|The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59202|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment|A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
59203|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||umol/l||Standard Deviation|Mean
59204|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||umol/l||Standard Deviation|Mean
59205|NCT01217112|Secondary|The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59206|NCT01217112|Secondary|The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59207|NCT01217112|Secondary|The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59208|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
59209|NCT01217112|Secondary|The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||ratio||Standard Deviation|Mean
59261|NCT01216397|Secondary|Assessment of Tolerability by the Investigator|Qualitative variable assessing the tolerability by the investigator|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
59210|NCT01217112|Secondary|The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59211|NCT01217112|Secondary|The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59212|NCT01217112|Secondary|The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59213|NCT01217112|Secondary|The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59214|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59215|NCT01217112|Primary|The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.||mmol/l||Standard Deviation|Mean
59216|NCT01217073|Secondary|Change From Baseline in FPG Levels at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
59217|NCT01217073|Secondary|Mean FPG Level at Baseline of the Extension Period|Plasma FPG levels were measured at baseline (Week 0) for particiapnts who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available FPG baseline data.||mg/dL||Standard Deviation|Mean
59218|NCT01217073|Secondary|Change From Baseline in 2h-PMG at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
59219|NCT01217073|Secondary|Mean 2h-PMG Level at Baseline of the Extension Period|Plasma 2h-PMG levels were measured at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available 2h-PMG baseline data.||mg/dL||Standard Deviation|Mean
59220|NCT01217073|Secondary|Change From Baseline in Plasma A1C Levels at Week 78|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.||Percent||95% Confidence Interval|Least Squares Mean
59221|NCT01217073|Secondary|Mean Plasma A1C Level at Baseline of the Extension Period|A1C levels were measured as a percent at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available A1C baseline data.||Percent||Standard Deviation|Mean
59222|NCT01217073|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
59223|NCT01217073|Secondary|Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||mg/dL||95% Confidence Interval|Least Squares Mean
59224|NCT01217073|Primary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 66 weeks (Weeks 12 to 78)|Analysis population defined as all randomized participants who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.||Percentage of participants|||Number
59225|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period)|Analysis population defined as all randomized participamts who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.||Percentage of participants|||Number
59226|NCT01217073|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 12 weeks|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.||Percentage of participants|||Number
59227|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 16 weeks (including 28 days following the last dose of study drug)|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.||Percentage of participants|||Number
59228|NCT01217073|Primary|Change From Baseline in Plasma A1C Levels at Week 12|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.||Percent||95% Confidence Interval|Least Squares Mean
59229|NCT01216943|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
59230|NCT01216761|Primary|Blood Culture Contamination|A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites.|5 days|Intention to treat analyses. Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.||blood culture sets|Blood culture sets||Number
59231|NCT01216748|Secondary|Exhaled Breath Condensate (EBC) pH Variation|"EBC samples were collected at each respiratory maneuver by directing the subject's exhaled breath into a pre-cooled (-10C) tube for 10 min.~pH was measured immediately after collection."|10 minutes after each respiratory manouver.|||pH||Standard Error|Mean
59232|NCT01216748|Primary|Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline|Effect of airway pH on albuterol responsiveness as reflected by the change in airway blood flow after 180μg albuterol by inhalation (ΔQaw) vs baseline.|15 minutes after albuterol inhalation|||changes from baseline in μl.min-1.ml-1||Standard Error|Mean
59233|NCT01216735|Secondary|Flow-mediated Brachial Vasodilation (FMD% Peak Delta)|Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation|3 weeks of treatment|||% change||Standard Error|Mean
59234|NCT01216735|Primary|Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo|Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).|3 weeks treatment period of ICS or placebo|||% change||Standard Error|Mean
59235|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|26 weeks||||||
59236|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|16 weeks||||||
59264|NCT01216397|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set||Participants|||Number
59265|NCT01216397|Secondary|Metformin: Vz/F|Geometric mean of Vz/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||Liter||Geometric Coefficient of Variation|Geometric Mean
59266|NCT01216397|Secondary|Metformin: CL/F|Geometric mean of CL/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||mL/min||Geometric Coefficient of Variation|Geometric Mean
59267|NCT01216397|Secondary|Metformin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of MRTpo of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
59268|NCT01216397|Secondary|Metformin: t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of t1/2 of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
59269|NCT01216397|Secondary|Metformin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of λz of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||1/hr||Geometric Coefficient of Variation|Geometric Mean
59270|NCT01216397|Secondary|Metformin: Tmax|Median of tmax of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Full Range|Median
59271|NCT01216397|Secondary|Metformin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of the percentage of AUCtz-infinity of Metformin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||percentage||Geometric Coefficient of Variation|Geometric Mean
59272|NCT01216397|Secondary|Metformin: AUC0-infinity|Geometric Mean of AUC0-infinity of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
59273|NCT01216397|Primary|Metformin: AUC0-tz|Geometric Mean of AUC0-tz of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
59274|NCT01216397|Primary|Metformin: Cmax|Geometric Mean of Cmax of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59275|NCT01216397|Secondary|Linagliptin: Apparent Volume of Distribution During the Terminal Phase Following an Extravascular Dose (Vz/F)|Geometric mean of the Vz/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||Liter||Geometric Coefficient of Variation|Geometric Mean
59276|NCT01216397|Secondary|Linagliptin: Apparent Clearance of the Analyte in Plasma After Extravascular Administration (CL/F)|Geometric mean of the CL/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||mL/min||Geometric Coefficient of Variation|Geometric Mean
59277|NCT01216397|Secondary|Linagliptin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of the MRTpo of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
59278|NCT01216397|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of the t1/2 of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Geometric Coefficient of Variation|Geometric Mean
59279|NCT01216397|Secondary|Linagliptin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of the λ_z of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||1/hr||Geometric Coefficient of Variation|Geometric Mean
59280|NCT01216397|Secondary|Linagliptin: Time to Maximum Measured Concentration of the Analyte in Plasma (Tmax)|Median of the t_max of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||hr||Full Range|Median
59281|NCT01216397|Secondary|Linagliptin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of percentage of AUCtz-∞ of linagliptin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||percentage||Geometric Coefficient of Variation|Geometric Mean
59282|NCT01216397|Secondary|Linagliptin: AUC0-infinity|Geometric mean of AUC0-infinity of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
59283|NCT01216397|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)|Geometric mean of AUC0-72 of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
59284|NCT01216397|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|Geometric mean of Cmax of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
59285|NCT01216319|Secondary|Rate of Patient Satisfaction|Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.|12 months|||percentage of patients|||Number
59286|NCT01216319|Primary|Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)||12 months|There were two patients (three nipples) without plastic surgery matrix in place at 12MO.||percentage of projection vs baseline|Participants|Standard Deviation|Mean
59287|NCT01216241|Primary|Percentage of Afebrile Neutropenic Subjects|To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.|5 days|||participants|||Number
59288|NCT01216163|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59289|NCT01216163|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
63196|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
59290|NCT01216163|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
59291|NCT01216163|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||hours||95% Confidence Interval|Median
59292|NCT01216163|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
59293|NCT01216163|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled ‘meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||percentage of participants|||Number
59294|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59295|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59296|NCT01216163|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best).|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59297|NCT01216163|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59298|NCT01216163|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59299|NCT01216163|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59300|NCT01216163|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
59301|NCT01216163|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||minutes||95% Confidence Interval|Median
61197|NCT01195090|Secondary|Percentages of Patients With Gastrointestinal Adverse Events|Proportion of Gastrointestinal adverse events after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentge|||Number
59302|NCT01216163|Primary|Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||units on a scale||Standard Deviation|Mean
59303|NCT01216072|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.|Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with month 3 and month 6 assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
59304|NCT01216072|Secondary|Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
59305|NCT01216072|Secondary|Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
59306|NCT01216072|Secondary|Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4|The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
59307|NCT01216072|Secondary|Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4|The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
59308|NCT01216072|Secondary|Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4|The effectiveness scale was scored as follows: 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
59319|NCT01215968|Primary|Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy|After at least 8 hours fasting, participants received a radiolabeled breakfast containing technetium-99m-tin colloid (99mTc-tin colloid). After which serial anterior and posterior scintigraphy images were taken. Data presented are the time required for 50% of radioactivity to be emptied from stomach. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for weeks.|Days 3, 10,17, 24 and 31|All randomized participants who received study drug, a radiolabeled breakfast, and had scintigraphy images taken. Those who violated protocol were excluded.||hours||90% Confidence Interval|Geometric Mean
90588|NCT00904826|Primary|Median Number of Neuromyelitis Optica (NMO) Attacks Per Year||baseline, after 12 months of treatment|||attacks per year||Full Range|Median
59309|NCT01216072|Secondary|Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)|The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
59310|NCT01216072|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6|The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
59311|NCT01216072|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|9 months (6 month core + 3 month Extension)|Safety Set included all patients who received at least one dose of study drug.||Participants|||Number
59312|NCT01216072|Primary|Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6|The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.||units on a scale||Standard Deviation|Mean
59313|NCT01215981|Secondary|Number of Subjects With H3 Based Immune Response to Vaccine|The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.||Patients|||Number
59314|NCT01215981|Primary|Number of Subjects With T-Cell Based Immune Response to Vaccine|The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.||Patients|||Number
59315|NCT01215968|Secondary|Number of Participants With Clinically Significant Effects|Adverse events (AEs) were considered clinically significant effects. A summary of serious adverse events (SAEs) and other nonserious AEs are located in the Reported Adverse Event section.|Baseline through 5 weeks|All enrolled participants who received at least one dose of study drug.||participants|||Number
59316|NCT01215968|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Tmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.||hour||Full Range|Median
59317|NCT01215968|Secondary|Maximum Concentration (Cmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Cmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
59318|NCT01215968|Secondary|Area Under the Curve (AUC) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as AUC) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying. AUC of metformin was calculated during one dosing interval.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had PK data. Those who violated protocol were excluded.||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
61198|NCT01195090|Secondary|Percentages of Patients With Edema|proportion of edema after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
59320|NCT01215955|Secondary|Percentage of Participants With Severe Hypoglycemic Episodes|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose.|Randomization up to 24 weeks|All randomized participants except those from the excluded site.||percentage of participants|||Number
59321|NCT01215955|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of hypoglycemic episodes reported divided by the number of days at risk times 30.|Randomization through 24 weeks overall|All randomized participants except those from the excluded site.||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
59322|NCT01215955|Secondary|The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence)|A hypoglycemic episode in participants ≥ 65 years of age was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants ≥65 years old except those from the excluded site.||participants|||Number
59323|NCT01215955|Secondary|The Number of Participants With a Hypoglycemic Episode (Incidence)|A hypoglycemic episode was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants except from the excluded site.||participants|||Number
59324|NCT01215955|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Total, basal and prandial amounts were then divided by the participant's body weight in kilograms (kg). Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.||international units/kilogram (IU/kg)||Standard Error|Least Squares Mean
59325|NCT01215955|Secondary|Daily Dose of Insulin: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.||international units (IU)||Standard Error|Least Squares Mean
59326|NCT01215955|Secondary|Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile|7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 time a day at the morning pre-meal, morning 2-hours (HR) postprandial (PP), midday pre-meal, midday 2-hours post-meal, evening pre-meal, bedtime and 0300 hour (3 am). Each participant took measures over any 3 days and the average was calculated for each of the 7 time points. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and had values at baseline and the specified timepoint, except participants from the excluded site.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
59327|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG)|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline 1,5-AG value, except participants from the excluded site.||microgram/milliliter (mcg/mL)||Standard Error|Least Squares Mean
59328|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, who are ≥65 years of age with baseline fasting glucose values, except participants from the excluded site.||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
59329|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline fasting glucose values, except participants from the excluded site.||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
59354|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)|SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.|12 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
59330|NCT01215955|Secondary|Time to Reach Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants is the number of participants who achieved HbA1c target values of ≤6.5% or ≤7.0% during the specified time period divided by the total number of participants who did not discontinue from the study but had not reached HbA1c target at the beginning of the specified post baseline time period (≤100 days and ≥101 days). Participants who did not experience an outcome before discontinuation or completion of the study were censored using the date of discontinuation. Participants who were lost to follow up the date of discontinuation were considered to be the date of last contact.|Baseline through 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site. Censored participants: Study A: ≤6.5% Q1D=186 and Q3D=197; Study A ≤7.0% Q1D=120 and Q3D=134; Study B: ≤6.5% Q1D=206 and Q3D=212, Study B ≤7.0% Q1D=135 and Q3D=152.||percentage of participants|||Number
59331|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Body Weight|Body weight was measured twice at each indicated visit and the average of the 2 measurements was used for analyses. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction .|Baseline, 24-weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized and received ≥1 dose of study insulin with a baseline body weight, except participants from the excluded site.||kilograms (kg)||Standard Error|Least Squares Mean
59332|NCT01215955|Secondary|Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration|Percentage of participants ≥65 years of age achieving HbA1c target concentration of ≤7.0% or ≤6.5%.|24-week endpoint|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and were ≥65 years of age, except participants from the excluded site. Last observation carried forward (LOCF) was used.||percentage of participants|||Number
59333|NCT01215955|Secondary|Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants who achieved HbA1c levels of ≤7.0% or ≤6.5%.|24-week endpoint|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site; last observation carried forward (LOCF) was used.||percentage of participants|||Number
59334|NCT01215955|Primary|Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c)|The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate.|Baseline, 24 weeks|Full Analysis Set: All participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with a baseline value for HbA1C, except participants from the excluded site.||percentage HbA1c||Standard Error|Least Squares Mean
59335|NCT01215929|Primary|Measure of Methamphetamine Withdrawal|Total score on the Methamphetamine Withdrawal Assessment scale (MAWA) based on DSMIV criteria for amphetamine withdrawal. This questionnaire is comprised of 13 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score indicating no methamphetamine withdrawal symptoms is 0 and the maximum score is 4 indicating that a patient has the most severe withdrawal symptom related to that question. The subscales are the 13 questions and the total score is the sum of all the scores for the 13 items on the scale. The range minium and better outcome is a lower score. The range is from 0-52. The worse outcome is reflected in a higher score.|at the end of week 4|||units on a scale||Standard Error|Least Squares Mean
59336|NCT01215851|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (TTP versus Day).|14 Days|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 81.||time (h) to positive per day||Standard Deviation|Mean
59337|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 7-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.||log10CFU/ml/day||Standard Deviation|Mean
59338|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 2-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 80.||log10CFU/ml/day||Standard Deviation|Mean
59355|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
59356|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
59339|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 0-2|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number patients analyzed for this measure was 84.||log10CFU/ml/day||Standard Deviation|Mean
59340|NCT01215851|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|14 consecutive days of treatment|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.||log10CFU/ml/day||Standard Deviation|Mean
59341|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 14|Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 14|The analysis population included all patients that started the study and were treated with AGN-207281.||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
59342|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 7|Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 7|The analysis population included all patients that started the study and were treated with AGN-207281.||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
59343|NCT01215786|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14|Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Day 14|Safety population, which consisted of all patients who started the study and received treatment.||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
59344|NCT01215734|Secondary|Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses|Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus|Before TIV and 28-42 days after TIV|Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients.||participants|||Number
59345|NCT01215734|Primary|Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients|Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.|Day of TIV to 7 days after TIV|Patients who received either the high-dose TIV or the standard dose TIV||participants|||Number
59346|NCT01215721|Primary|Time to Continence|Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.|12 months|||Days to Continence||Standard Deviation|Median
59347|NCT01215643|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.|within 24 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
59348|NCT01215643|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"Viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment"|within 24 weeks of treatment|Full Analysis Set||percentage of participants|||Number
59349|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
59350|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
59351|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)||24 weeks after the end of treatment|Full Analysis Set||percentage of participants|||Number
59352|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
59353|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
67538|NCT01132690|Secondary|Chitotriosidase|Percent change from baseline in chitotriosidase|Every 3 months for 12 months|||Percent Change from Baseline||Standard Deviation|Mean
59357|NCT01215643|Secondary|Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)|ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.|at end of treatment, within 24 weeks|Full Analysis Set||percentage of participants|||Number
59358|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
59359|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
59360|NCT01215643|Secondary|Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)|cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.|after 12 weeks of treatment|Full Analysis Set||percentage of participants|||Number
59361|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection||percentage of participants|||Number
59362|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection||percentage of participants|||Number
59363|NCT01215643|Secondary|Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)|RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set||percentage of participants|||Number
59364|NCT01215643|Primary|Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)|RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.||percentage of participants|||Number
59365|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in ECG Variables|This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).||Participants|||Number
59366|NCT01215513|Secondary|Serum Levels of Prostate Specific Antigen (PSA) Over Time|PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).|Day 0, day 196, day 280, and day 364|CS42 and CS42A full analysis set (data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing). The figures present the median of the absolute values at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).||ng/mL||Full Range|Median
59367|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).||Participants|||Number
59368|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|"The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study.~ULN=upper limit of normal"|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).||Participants|||Number
59369|NCT01215435|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.|Week 0 to Week 36|Safety analysis set includes all subjects who received at least one dose of the trial product.||episodes|||Number
59370|NCT01215435|Secondary|Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 weeks of treatment|Week 0, Week 36|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
59371|NCT01215435|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11|Estimated mean change from baseline in HbA1c after 11 weeks of treatment|Week 0, Week 11|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF)||percentage of glycosylated haemoglobin||Standard Error|Mean
59372|NCT01215422|Secondary|"Number of Intubation Attempts to Reach Best Obtainable Time to Intubation"|"For each anesthesiologist, the median time-to-intubation for patients #1-5, #6-10, #11-15, and #16-20 was determined. The anesthesiologist was considered to have reached Best Obtainable Time (BOT) to Intubation once the median time on any group of 5 consecutive patients was less than 3 seconds faster than the median time in the previous group of 5 consecutive patients, provided that there were no failed intubations or subsequent failed intubations using the same device."|less than 5 minutes per intubation|||participants|||Number
59373|NCT01215422|Secondary|Mean Years Since Completion of Anesthesiology Residency|To investigate whether there was a correlation between the years since completion of anesthesiology residency to the mid-point of study (2008)and median time-to-intubation for all first attempt intubations for the study. Years since completion of anesthesiology residency reported in the data table, correlation reported in the statistical analysis below|Baseline (assessed as of 2008)|||years||Full Range|Mean
59374|NCT01215422|Secondary|Time to Intubation, Stratified by Weight of Patients|To compare the time-to-intubation for these laryngoscopes in children of different weights.|4 years|Time to Intubation, Stratified by Weight of Patients||seconds||Standard Deviation|Mean
67539|NCT01132690|Primary|Hemoglobin|median and interquartile range for change from baseline in haemoglobin|Every 3 months for 12 months|||g/dL||Inter-Quartile Range|Median
59375|NCT01215422|Secondary|Time to Intubation, Analyzed by Order of Laryngoscopes Used|To determine if the learning curve was altered by the order in which the two new laryngoscopes were learned by the anesthesiologist,mean and median times on intubations #16-20 were compared for the two videolaryngoscopes.|4 years|Only anesthesiologists who completed minimum 18 intubations with each scope were included. We report the mean of their mean times and the mean of their median times on intubations #16-20 when they should have attained a reasonable skill level.||seconds|Participants|Standard Deviation|Mean
59376|NCT01215422|Secondary|Cormack & Lehane Score|This Outcome was designed to determine if the view of the airway as determined by the Cormack & Lehane grading system is improved by use of the GlideScope (GS) video laryngoscope and/or the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope as this would be a surrogate marker for utility in a difficult airway. Score is reported as a whole number from I to IV with I being an easy intubation and IV being one where the larynx cannot be visualized at all.|reported during intubation (up to 5 minutes)|Patients were excluded if the Cormack-Lehane score was not recorded.||Percentage of participants|||Number
59377|NCT01215422|Primary|Success in Learning to Use a Videolaryngoscope(VLS)|"Anesthesiologists were to perform 20 intubations with each videolaryngoscopes. #1-10 were for practice. Rapid Success was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 . Delayed Success was achieving these same parameters on #16-20 if they were not achieved on #11-15. Operators who did not achieve either goal were labeled as having No Success."|Up to 5 minutes per intubation|Only anesthesiologists who completed minimum 18 intubations with either laryngoscope were analyzed for the primary outcome.||percent of anesthesiologists|Participants||Number
59378|NCT01215357|Secondary|Effects on the Clinical Global Impression|Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study|6 weeks||||||
59379|NCT01215357|Secondary|Statistically Significant Changes in the Gambling Symptom Assessment Scale|It is expected that there will be decreases in this scale|6 weeks||||||
59380|NCT01215357|Secondary|Type, Frequency and Severity of Side Effects|All side effects of the drug will be monitored and recorded|6 weeks||||||
59381|NCT01215357|Primary|Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling|This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.|Baseline and 6 weeks|Patients completing all visits||YBOCS score||Standard Deviation|Mean
59382|NCT01215292|Primary|Intratesticular Androstenedione (ADD) Level||10 days|||ng/mL||Inter-Quartile Range|Median
59383|NCT01215292|Primary|Intratesticular Dihydrotestosterone (DHT) Level||10 days|||ng/mL||Inter-Quartile Range|Median
59384|NCT01215292|Primary|Intratesticular Testosterone (IT-T) Level||10 days|||ng/mL||Inter-Quartile Range|Median
59385|NCT01215279|Secondary|Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. (Vss/F) was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||L||Full Range|Geometric Mean
59386|NCT01215279|Secondary|Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||Hours||Full Range|Median
59387|NCT01215279|Secondary|Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||nmol/L||Full Range|Geometric Mean
59388|NCT01215279|Secondary|Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4|||nmol*h/L||Full Range|Geometric Mean
59389|NCT01215279|Secondary|SAA Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4|||ng/mL||Full Range|Geometric Mean
59390|NCT01215279|Secondary|Serum Amyloid-A (SAA) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1|||ng/mL||Full Range|Geometric Mean
59391|NCT01215279|Secondary|CCL2 Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4|||pg/mL||Full Range|Geometric Mean
59392|NCT01215279|Secondary|CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1|||pg/mL||Full Range|Geometric Mean
59393|NCT01215279|Secondary|SGRQ Total Score at End of Treatment|Decrease in score represents improved Quality of Life; increase represents deteriorated Quality of Life. An increase or decrease of 4 or more percent units is judged as the Minimal Clinically Important Difference.|week 4|||Percent of maximum possible score||Standard Deviation|Mean
59394|NCT01215279|Secondary|St George’s Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline|The SGRQ-C includes 40 questions in 3 domains: Symptoms (distress due to respiratory symptoms, 7 questions), Activity (disturbance of physical activity, 13 questions), Impacts (overall impact on daily life and well-being, 20 questions). Scores are expressed as a percentage. Baseline is Day 1.|Day 1|||Percent of maximum possible score||Standard Deviation|Mean
59395|NCT01215279|Secondary|Rescue Medication Use During the Last 7 Days of Treatment|Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day.|Average of the last 7 days of treatment (week 4)|||Inhalations||Full Range|Mean
59396|NCT01215279|Secondary|BCSS (Evening) Total Score During Last 7 Days of Treatment|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units.|Average of the last 7 days of treatment (week 4)|||Units on scale, 0-12||Standard Deviation|Mean
59517|NCT01214616|Primary|Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course|DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)|during 1st course|Treated set: all patients who received at least 1 dose of investigational medication (afatinib or vinorelbine)||participants|||Number
59397|NCT01215279|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. Baseline is mean of 10 days prior to treatment.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||Units on scale, 0-12||Standard Deviation|Mean
59398|NCT01215279|Secondary|EXACT Total Score During Last 7 Days of Treatment|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation).|Average of the last 7 days of treatment (week 4)|||Units on scale, 0-100||Standard Deviation|Mean
59399|NCT01215279|Secondary|Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). Baseline is the mean value over the 7 days prior to randomisation.|Average of 7 days of pre-treatment measurements (day -7 to -1)|||Units on scale, 0-100||Standard Deviation|Mean
59400|NCT01215279|Secondary|Evening PEF During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)|||L/minute||Standard Deviation|Mean
59401|NCT01215279|Secondary|Evening PEF at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L/minute||Standard Deviation|Mean
59402|NCT01215279|Secondary|Morning PEF During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)|||L/minute||Standard Deviation|Mean
59403|NCT01215279|Secondary|Morning Peak Expiratory Flow (PEF) at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L/minute||Standard Deviation|Mean
59404|NCT01215279|Secondary|Evening FEV1 During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)|||L||Standard Deviation|Mean
59405|NCT01215279|Secondary|Evening FEV1 at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L||Standard Deviation|Mean
59406|NCT01215279|Secondary|Morning FEV1 During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)|||L||Standard Deviation|Mean
59407|NCT01215279|Secondary|Morning FEV1 at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)|||L||Standard Deviation|Mean
59408|NCT01215279|Primary|Monocytes at Follow-up|Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)|week 5 (follow-up)|||10^9/L||Standard Deviation|Mean
59409|NCT01215279|Primary|Monocytes at End of Treatment|Monocyte count in peripheral blood at end of treatment (4 weeks)|week 4|||10^9/L||Standard Deviation|Mean
59410|NCT01215279|Primary|Monocytes at Baseline|Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)|Day 1|||10^9/L||Standard Deviation|Mean
59411|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Physical Examination|Number of participants with clinically significant changes in physical examination assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
59412|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in ECG Variables|Number of participants with clinically significant changes in ECG variables assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
59413|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Number of participants with clinically significant changes in vital signs assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
59414|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes|Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)|||Participants|||Number
59415|NCT01215227|Primary|Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness.|Baseline and Week 40|Participants in the Full Analysis Set (FAS) population (all randomized participants who received at least one dose of study drug) that had a baseline value and data at Week 40 for Total ESS Score||Percentage change||95% Confidence Interval|Mean
59416|NCT01215227|Primary|Percentage of Participants With Suicidality|The number of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
59417|NCT01215227|Primary|Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
59418|NCT01215227|Primary|Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
59419|NCT01215227|Primary|Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg|The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
59420|NCT01215227|Primary|Percentage of Participants With Systolic Blood Pressure ≥180 mmHg|The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug.||Percentage of participants|||Number
59421|NCT01215123|Secondary|Treatment Duration: Number of Bevacizumab Cycles|Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.|Up to a maximum of 36.4 months|All enrolled participants||cycles||Full Range|Median
59422|NCT01215123|Primary|Time to Disease Progression (TDP)|Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to a maximum of 36.4 months|All enrolled participants||months||Full Range|Median
59423|NCT01215097|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Participants|||Number
59424|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||Participants|||Number
59425|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Participants|||Number
59426|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||Participants|||Number
59427|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Participants|||Number
59428|NCT01215097|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59429|NCT01215097|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59430|NCT01215097|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59431|NCT01215097|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59432|NCT01215097|Secondary|HbA1c Change From Baseline at Week 24(Chinese Only)|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at 24 weeks|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (Chinese only). Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
59433|NCT01215097|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
59434|NCT01215097|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
59435|NCT01215097|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
59436|NCT01215097|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
59437|NCT01214980|Secondary|Donor Site Recidivism Rate|Number of donor sites that healed and then reopened during the study.|6 weeks|Randomized subjects that had a minimum of 4 out of 5 study treatments and fully epithelialized during the study.||participants that healed and reopened|||Number
59438|NCT01214980|Secondary|Numeric Itching Score|Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure|5 weeks|Randomized subjects with a minimum of 4 out of 5 study treatments and itching score reported||units on a scale||Standard Error|Mean
59439|NCT01214980|Secondary|Numeric Pain Score|Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure|5 weeks|randomized subjects that had a minimum of 4 out of 5 study treatments and with a numeric pain score reported||units on a scale||Standard Error|Mean
59440|NCT01214980|Secondary|Time to Full Epithelialization|Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.|Days to full epithelialization|randomized subjects that had a minimum of 4 out of 5 study treatments||days||Standard Deviation|Mean
59441|NCT01214980|Primary|Rate of Wound Healing|The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure.|Days to absence of drainage from the initial donor site harvest procedure|randomized participants that had a minimum of 4 out of 5 treatments||Days||Standard Deviation|Mean
59442|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
59443|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
59444|NCT01214915|Secondary|Percentage of Subjects With Normalization in Platelet Count|Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
59445|NCT01214915|Secondary|Percentage of Subjects With at Least 50% Reduction in Platelet Count|Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
59446|NCT01214915|Primary|Percentage of Subjects Who Responded in Platelet Count|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.||percentage of subjects||95% Confidence Interval|Number
59447|NCT01214850|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group|The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.|Day 1 through day 7 after any vaccination|Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.||number of subjects|||Number
59448|NCT01214850|Secondary|Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.|"The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.~Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Percentages of subjects||95% Confidence Interval|Number
67709|NCT01130844|Primary|AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|PKS||ug*h/L||Standard Deviation|Mean
59449|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group|"The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.~Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Titers||95% Confidence Interval|Geometric Mean
59450|NCT01214850|Secondary|Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.|"The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.~Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.~Analysis was not done for serogroups A and W."|61 days|Analysis was done on the MITT dataset (Immunogenicity subset)||Percentages of subjects||95% Confidence Interval|Number
59451|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.~Serogroups A and W were not analysed."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Titers||95% Confidence Interval|Geometric Mean
59452|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.~As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Percentages of subjects||95% Confidence Interval|Number
59453|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)||Titers||95% Confidence Interval|Geometric Mean
59454|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group|The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.||Percentages of subjects||95% Confidence Interval|Number
59455|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers|The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.|Up to 12 months after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59456|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination|"The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.~The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).~H44/76, 5/99 and NZ98/254 are strains in serogroup B."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentage||95% Confidence Interval|Number
59457|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
59458|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
59459|NCT01214850|Secondary|The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM|The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.|Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
59460|NCT01214850|Secondary|The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV|The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)||Number of days||95% Confidence Interval|Least Squares Mean
59461|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59462|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59463|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59464|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59465|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59466|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59467|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59468|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59469|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59470|NCT01214850|Secondary|Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59471|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59472|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MIIT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59473|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
61199|NCT01195090|Secondary|Percentages of Patients With Mild to Moderate Hypoglycemia|Incidence of mild to moderate hypoglycemia after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
59474|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59475|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59476|NCT01214850|Secondary|Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59477|NCT01214850|Secondary|Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59478|NCT01214850|Secondary|Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59479|NCT01214850|Secondary|Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination|The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59480|NCT01214850|Primary|Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination|The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|31 days after MenACWY-CRM injection|Analysis was done on the MITT dataset (Pharyngeal carriage)||Percentages of subjects||95% Confidence Interval|Number
59481|NCT01214850|Primary|Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination|"Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.~Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010."|61 days (31 days after receiving the second injection)|Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.||Percentages of subjects||95% Confidence Interval|Number
59482|NCT01214837|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.||13 months of age|Analysis was done on the Unsolicited Safety Set - All subjects in the Exposed Set with unsolicited adverse event data.||Subjects|||Number
59483|NCT01214837|Secondary|Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.|Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.|Day 1 through Day 7|Analysis was done on Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data||Subjects|||Number
59484|NCT01214837|Secondary|Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.|Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.|Within 7 days|Analysis was done on the Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data||Percentage of subjects|||Number
59485|NCT01214837|Secondary|Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.|Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.|13 months of age.|Analysis was done on the Toddler PPS.||µg/mL||95% Confidence Interval|Geometric Mean
59486|NCT01214837|Secondary|Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.|Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.|7 months of age.|Analysis was done on the Infant PPS.||Percentage of subjects||95% Confidence Interval|Number
59536|NCT01214239|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59487|NCT01214837|Secondary|Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.|The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.||Percentage of subjects||95% Confidence Interval|Number
59488|NCT01214837|Secondary|GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.|Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.||Titers||95% Confidence Interval|Geometric Mean
59489|NCT01214837|Secondary|Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.|The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age|Analysis was done on the Toddler PPS.||Titers||95% Confidence Interval|Geometric Mean
59490|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.|Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age.|Analysis was done on the Toddler PPS.||Percentage of subjects||95% Confidence Interval|Number
59491|NCT01214837|Secondary|Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.|Analysis was done on the Infant PPS.||Titers||95% Confidence Interval|Geometric Mean
59492|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.|Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age|Analysis was done on Infant PPS - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding, through the 7 month timepoint.||Percentages of subjects||95% Confidence Interval|Number
59493|NCT01214837|Primary|Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.|13 months of age|Analysis was done on Toddler PPS.||Percentage of subjects||95% Confidence Interval|Number
59494|NCT01214837|Primary|Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.|13 months of age|Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.||Percentage of subjects||95% Confidence Interval|Number
59495|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked|Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase|2 weeks following baseline & 3 months|Analysis per protocol 31 participants analysed in the unmasked phase 1 28 participants analysed in the unmasked phase 2||Hours per day||Standard Deviation|Mean
59496|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked|Proportion of time (hours per day) in hypoglycaemia (<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device.|Baseline & 6 months|Analysis per protocol||Hours per day||Standard Deviation|Mean
59497|NCT01214824|Secondary|Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%|Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months).|Baseline and 6 months|Intention to treat analysis||participants|||Number
59498|NCT01214824|Primary|Change in HbA1C From Baseline to 6 Months|HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months – baseline)|Baseline and 6 months|Intention to treat analysis||HbA1c %||Standard Deviation|Mean
59499|NCT01214811|Primary|Wound Area at Visit 2|At each visit the wound length and width is measured and calculated in cm2.|After one week|||cm2||Standard Deviation|Mean
59500|NCT01214811|Primary|Wound Are at Baseline||Baseline||||||
59501|NCT01214759|Secondary|Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study||28 days|All who were enrolled||participants|||Number
59502|NCT01214759|Secondary|Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study|Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.|28 days|Only participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table were tested for clinical or laboratory abnormalities, and since no participants experienced side effects greater than grade 1, no participants were tested for clinical or laboratory abnormalities.|||||
59503|NCT01214759|Primary|Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months|This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.|6 months|All who completed all study visits||participants|||Number
67710|NCT01130844|Primary|Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State|Clearance of a substance from the blood by the kidneys.|Over a 24-hour period starting on day 7|PKS||L/h||Standard Deviation|Mean
59504|NCT01214720|Secondary|Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib|Blood samples were collected from a subgroup of participants, in selected centers for the determination of bevacizumab serum concentration before the first bevacizumab/placebo exposure (Week 1) and at Weeks 3, 5, 7, and 9. Each time blood samples were collected just (preferably within 1 hour) before the start of the study treatment.|Weeks 1, 3, 5, 7, and 9|ITT Population. Number (n) = number of participants assessed at a specific visit.||micrograms/milliliter||Standard Deviation|Geometric Mean
59505|NCT01214720|Primary|Duration of Overall Survival - Time to Event|Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT Population.||months||95% Confidence Interval|Median
59506|NCT01214720|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment|Percentage of participants with CR, PR, or SD according to modified RECIST evaluation at the first postbaseline tumor assessment. CR equaled (=) complete disappearance of all target lesions and non-target disease, with normalization of tumor marker level. PR is greater than or equal to (≥) a 30% decrease of the sum of the LD of all target lesions as referenced to the baseline sum LD of all target lesions. Persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. SD=neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD with persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits.|Baseline and Week 8|ITT Population.||percentage of participants||95% Confidence Interval|Number
59507|NCT01214720|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined as the time between the date of randomization and the date of documented PD (per RECIST), or date of death due to any cause. Data for participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median PFS was estimated using the Kaplan-Meier method.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT Population||months||95% Confidence Interval|Median
59508|NCT01214720|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time between the date of randomization and the date of documented progressive disease (PD) defined according to modified Response Evaluation Criteria in Solid Tumors (RECIST) evaluation, or date of death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum (LD) recorded since the treatment started. Participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT population.||percentage of participants|||Number
59509|NCT01214720|Secondary|Clinical Benefit Response (CBR)||Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|The analysis of the CBR was dependent on the calculation of analgesic therapy (AT); this calculation relies on established conversion factors for different morphine derivatives (MD). Many MD utilized by participants do not have well-established conversion factors, yielding uninterpretable results. Therefore, CBR was not analyzed in this study.|||||
59510|NCT01214720|Primary|Duration of Overall Survival - Percentage of Participants With an Event|Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT population.||percentage of participants|||Number
59511|NCT01214616|Primary|Drug-related Adverse Events|Number of patients with drug-related adverse events|during the treatment period or up to 28 days after the completion of drug administration, up to 730 days|Treated set||participants|||Number
59512|NCT01214616|Secondary|Objective Tumour Response|"According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Pre-treatment, every 8 weeks after start of study treatment, end of treatment|Treated set||participants|||Number
59513|NCT01214616|Secondary|Cmax for Vinorelbine|maximum measured blood concentration|predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as “with afatinib”) and 1st dose (as “without afatinib”)|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59514|NCT01214616|Secondary|AUC0-∞ for Vinorelbine|area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity|predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as “with afatinib”) and 1st dose (as “without afatinib”)|Treated set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
59515|NCT01214616|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration at steady state|pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as “with Vinorelbine”) and 20th dose (as “without Vinorelbine”)|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59516|NCT01214616|Secondary|AUCτ,ss for Afatinib|area under the plasma concentration-time curve following dose at steady state over the dosing interval τ|pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as “with Vinorelbine”) and 20th dose (as “without Vinorelbine”)|Treated set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
59518|NCT01214434|Secondary|Percent Reduction From Baseline for Oiliness at End of Treatment.|Oiliness scored on a scale of 0 (none) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
59519|NCT01214434|Secondary|Percent Reduction From Baseline for Erythema at End of Treatment.|Erythema scored on scale of 0 (none) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
59520|NCT01214434|Secondary|Percent Reduction From Baseline for Crusting at End of Treatment.|Crusting scored on a scale of 0 (none) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
59521|NCT01214434|Secondary|Precent Reduction From Baseline for Scaling at End of Treatment.|Scaling score on a scale of 0 (none) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percent reduction from baseline||Standard Deviation|Mean
59522|NCT01214434|Primary|Number of Participants With Excellent Overall Safety Score at End of Treatment.|The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).|End of treatment|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||participants|||Number
59523|NCT01214434|Primary|Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).|IGA scored on scale of 0 (clear) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.||percentage of participants|||Number
59524|NCT01214395|Secondary|The Number of Patients That Did Not Have a Staphylococcus Aureus Infection||6 months|counted||participants|||Number
59525|NCT01214395|Primary|Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial.|"Catheter-related infections will be defined according to standard guidelines~Cases with definite and probable infections will be classified as infections."|6 months|||participants|||Number
59526|NCT01214330|Secondary|Patient Attitudes|Results from SoloPap Patient Questionairre regarding patient attitudes.|6 months||||||
59527|NCT01214330|Primary|Concordance (Similarity Between Samples) of Pap Smears|Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?|1 year|102 females recruited from an outpatient clinic in a military treatment facility, age >18, without severe hand arthritis||percentage of participants|||Number
59528|NCT01214252|Secondary|Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed|Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed|Year 2 to Year 8|||participants|||Number
59529|NCT01214252|Secondary|Total Unconfirmed Hernia or Hernia Recurrence|"Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage)~Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review"|12 Months|||participants|||Number
59530|NCT01214252|Primary|Confirmed Hernia Recurrence|Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review|12 months|||participants|||Number
59531|NCT01214239|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Patients|||Number
59532|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||Patients|||Number
59533|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Patients|||Number
59534|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||Patients|||Number
59535|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Patients|||Number
59537|NCT01214239|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59538|NCT01214239|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59539|NCT01214239|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
59540|NCT01214239|Secondary|HbA1c Change From Baseline at Week 24 in the Subset of Chinese Patients|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (in the subset of Chinese patients). Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
59541|NCT01214239|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
59542|NCT01214239|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
59543|NCT01214239|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
59544|NCT01214239|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||% of HbA1c||Standard Error|Least Squares Mean
59545|NCT01214174|Primary|Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.|8 days post-treatment|||percentage of patients with ACC clearing||95% Confidence Interval|Number
59546|NCT01214161|Secondary|Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale|This secondary analysis looked at provider perception of patient maximum pain during IUD insertion This was not done per intervention because we were looking at the accuracy of the provider's assesment of the patient's pain, which is not dependent on intervention. The provider was blinded to the intervention so that would not have influenced results.|during IUD insertion|||units on a 100 mm visual analogue scale||Standard Deviation|Mean
59547|NCT01214161|Secondary|Adverse Events||During IUD insertion|||participants|||Number
59548|NCT01214161|Primary|Pain During IUD Insertion at Various Time Points (See Description for Time Points)|Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.|During IUD insertion (see above description for which time points)|||units on a 100 mm visual analogue scale||Standard Deviation|Mean
59549|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Vz/F,ss excluding subjects with reported emesis||L||Geometric Coefficient of Variation|Geometric Mean
59550|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population - Subjects with values for Vz/F,ss||L||Geometric Coefficient of Variation|Geometric Mean
59551|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for CL/F,ss excluding subjects with reported emesis||mL/min||Geometric Coefficient of Variation|Geometric Mean
59552|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population - Subjects with values for CL/F,ss||mL/min||Geometric Coefficient of Variation|Geometric Mean
59553|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cmin,ss excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
94430|NCT00860470|Secondary|Post-neonatal Mortality|Risk of Post-neonatal Mortality (29th -180th day of life)|Dec 2014|||participants|||Number
59554|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cmin,ss||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59555|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for t1/2,ss excluding subjects with reported emesis||h||Geometric Coefficient of Variation|Geometric Mean
59556|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population - Subjects with values for t1/2,ss||h||Geometric Coefficient of Variation|Geometric Mean
59557|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cavg excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59558|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cavg||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59559|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cpre,ss excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59560|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population - Subjects with values for Cpre,ss||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59561|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population excluding subjects with reported emesis - Subjects with values for PTF excluding subjects with reported emesis||percent||Geometric Coefficient of Variation|Geometric Mean
59562|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population - Subjects with values for PTF||percent||Geometric Coefficient of Variation|Geometric Mean
59563|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)|tmax = time of maximum observed plasma concentration|27 days|PK population excluding subjects with reported emesis - Subjects with values for t_max excluding subjects with reported emesis||hours||Full Range|Median
59564|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)|tmax = time of maximum observed plasma concentration|27 days|PK population - Subjects with values for tmax||hours||Full Range|Median
59565|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmax,ss = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cmax,ss excluding subjects with reported emesis||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59566|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)|Cmax = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population - Subjects with values for Cmax,ss||ng/mL||Geometric Coefficient of Variation|Geometric Mean
59567|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER, excluding subjects with reported emesis||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
59568|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
59569|NCT01213966|Primary|Derived Parasite Reduction Rate at 24 Hours (PPR24)|"PRR24 is the log10 change in parasitemia over 24 hours estimated from a regression model fit separately for each patient. The relationship between parasite counts and time was analyzed by fitting a variable lag phase, then a linear decline to the natural log of parasite count versus time relationship. The slope of this log linear relationship is the primary end-point.~The time points chosen for the regression are those that yield the highest degree of significance when assessing the regression when the number of time points are greater than or equal to 3. No extrapolation was performed."|24 hours after study drug administration|||Log10 parasites/24h||Full Range|Median
59570|NCT01213836|Secondary|Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2.|The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively.|End of Period 1, end of Period 2|21 patients for the FAS were analysed. This outcome measure was introduced as a protocol amendment after study start and plasma concentration was not measured in all patients. FAS is all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.||Ratio||Standard Deviation|Mean
59571|NCT01213836|Secondary|Number of Dropouts.|The number of patients who dropped out was counted.|Period 1 and Period 2|The Safety analysis set was used, that is all patients who received at least one dose of study medication and for whom any post-dose safety data are available were included in the safety set.||participants|||Number
59572|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label|"Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie).~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.||units on a scale||Standard Deviation|Mean
59573|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label|"The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres.~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.||units on a scale||Standard Deviation|Mean
59574|NCT01213836|Secondary|Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving|International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|Per Protocol (PPS), subset of the FAS consisting of patients who fulfilled all of inclusion but none of exclusion criteria, complied with study medication dosing, did not violate any of the restrictions and completed the study without protocol violation.||Units on a scale||Standard Deviation|Mean
59575|NCT01213836|Secondary|Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)|"TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction.~There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group."|Before taking study drug, end of Period 1 and end of Period 2|Full Analysis Set (FAS)used for efficacy analysis included all patients who in both study periods, received at least 1 dose of investigational product and for whom post-dose efficacy data was available.||units on a scale||Standard Deviation|Mean
59576|NCT01213836|Primary|Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)|Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The per protocol set (PPS) is a subset of the FAS consisting of patients who fulfilled all inclusion criteria but none of the exclusion criteria, complied with study medication dosing scheme, did not violate any of the study restrictions and completed the study without protocol violation.||standardised units||Standard Deviation|Mean
59577|NCT01213823|Primary|Number of Any Severe Hepatic Injury Cases and Matched Controls|Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [ULN] and direct bilirubin >2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels >3 times ULN and less than (<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.|01 June 2006 to 30 June 2008 (up to 25 Months)|Acute-care participants, with at least 1 dose of echinocandin antifungal therapy and a primary or secondary International Classification of Diseases 9 (ICD-9).||Participants|||Number
59578|NCT01213706|Primary|Airway Blood Flow Response to Albuterol|Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.|Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA|controls n =15, smokers N=15 , asthma N=15||μl/min/ml||Standard Error|Mean
59603|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Operating Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Operating Room. The time of dismissal from the Operating Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical period (up to approximately 24 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.||minutes||Standard Deviation|Mean
59579|NCT01213589|Secondary|Clinical Success|"Clinical success was defined as: (i) successful introduction and deployment of the Valiant Thoracic Stent Graft at the intended location; (ii) successful coverage of the proximal entry tear; (iii) no immediate conversion to open surgery;(iv) absence of surgical open repair or endovascular re-intervention; (v) absence of death related to aortic disease or treatment; (vi) absence of graft thrombosis, obstructions, twists or kinks; (vii) absence of graft migration;(viii) absence of graft integrity failure; (ix) at the level of the ostium of the LSA, the more proximal entry tear of the dissection, the largest section of the thoracic aorta, and at the first image/slice available with upper part of the liver:~Absence of true lumen decrease in diameter (≥ 5 mm is significant) Absence of increase in total aortic diameter (≥ 5 mm is significant)"|through 36 months|||participants|||Number
59580|NCT01213589|Secondary|Freedom From Disease-, Procedure-, or Device-related Severe Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.~Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related severe complications"|through 36 months|||Percentage Event Free|||Number
59581|NCT01213589|Secondary|Freedom From Disease-, Procedure- or Device-related Major Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A moderate complication indicates the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not preclude normal daily activity. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death. Both moderate and severe complications are considered as major complications.~Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related major complications by clinical group."|through 36 months|||Percentage Event Free|||Number
59582|NCT01213589|Secondary|Freedom of Re-intervention|Kaplan-Meier estimate of freedom from secondary procedures by clinical group.|30 days or at discharge, 3/6/12/24/36 months|||Percentage Event Free|||Number
59583|NCT01213589|Secondary|Efficacy/Performance|- Technical Success Technical success, defined as a composite of (i) successful introduction and deployment of at least one Valiant Thoracic Stent Graft at the intended location, (ii) successful coverage of the proximal entry tear, (iii) no immediate conversion to open surgery during the same intervention, (iv) absence of death within 24 hours post-procedure, and (v) the absence of significant graft twist, kink or obstruction by intra-operative measurements|30 days or at discharge, 3/6/12/24/36 months|||participants|||Number
59584|NCT01213589|Secondary|Safety|"All causes mortality~Disease-, procedure- or device-related mortality"|30 days or at discharge, 3/6/12/24/36 months|||participants|||Number
59585|NCT01213589|Primary|Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure|Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.|12 months post-procedure|||participants|||Number
59586|NCT01213576|Secondary|Number of Participants With Microfilarial Clearance at 24 Months of Follow up|Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample|24 months|Intention to treat, with last result carried forward in the case of missing visit||participants|||Number
59587|NCT01213576|Primary|Number of Participants Achieving Microfilarial Clearance|Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.|12 months|Number of participants with non detectable microfilaria at follow up||participants|||Number
59588|NCT01213329|Secondary|Identify Development of Donor-specific Hyperactivity|Identify, by studying recipients for development of donor specific hyperactivity and through immunopathologic analysis of renal allograft biopsies, immunologically stable renal transplant patients in whom immunosuppression can be safely minimized.|Pre-transplant, 6mo & 12mo post-transplant||||||
59589|NCT01213329|Primary|The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.|Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months & 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells & NK cells, naive & memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). To also obtain quantification of donor specific antibody cells for class I & class II donor HLA antigens, and measurement of C-reactive protein cells(marker of inflammation). 50cc of urine also obtained for measurement of urinary cytokines & markers of inflammation.|Pre-transplant, 6months & 12 months post-transplant|samples from 26 recipient/donor pairs were collected = 52 analyzed. Some samples were discarded due to processing inconsistencies.|||||
59590|NCT01213316|Secondary|Percentage of Aging Participants Taking Concomitant Medications at Baseline|The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Percentage of participants|||Number
59591|NCT01213316|Secondary|Percentage of Aging Participants With Concomitant Diseases at Baseline|The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Percentage of participants|||Number
59604|NCT01213264|Primary|Type of Surgical Procedure Performed in Study Participants|The type of surgical procedure performed in each study participant was recorded.|Day of surgery (Day 1)|All study participants who received a neuromuscular blocking agent (NMBA) or NMB-reversal agent||participants|||Number
60672|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 30||Baseline (Day 1) and Week 30|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 30||log10 Copies/mL||Full Range|Median
59592|NCT01213316|Secondary|Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.||Percentage risk||Standard Deviation|Mean
59593|NCT01213316|Secondary|Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.||Percentage risk||Standard Deviation|Mean
59594|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||CD4+ T-cells/µL||Standard Deviation|Mean
59595|NCT01213316|Secondary|HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Log10 Copies/mL||Standard Deviation|Mean
59596|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.||CD4+ T-cells/µL||Standard Deviation|Mean
59597|NCT01213316|Secondary|HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.||Log10 Copies/mL||Standard Deviation|Mean
59598|NCT01213316|Secondary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.||Percentage of participants||95% Confidence Interval|Number
59599|NCT01213316|Primary|Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.||Percentage of participants||95% Confidence Interval|Number
59600|NCT01213316|Primary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included all participants who received at least one dose of raltegravir during the observation period.||Percentage of participants||95% Confidence Interval|Number
59601|NCT01213264|Primary|Type of NMB-reversal Agent Administered to Study Participants|For all participants who received an NMB-reversal agent, the specific agent administered was recorded.|At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)|All study participants who received an NMBA or NMB-reversal agent||participants|||Number
59602|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Recovery Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Recovery Room. The time of dismissal from the Recovery Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical and recovery period (up to approximately 170 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.||minutes||Standard Deviation|Mean
60673|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 24||Baseline (Day 1) and Week 24|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 24||log10 Copies/mL||Full Range|Median
59605|NCT01213264|Primary|Time From End of Surgery (End of Last Stitch) to Extubation|"This measure is the duration from the last surgical wound stitch to the post-surgical extubation of the participant. The time of extubation was to be recorded for each participant, irrespective of the criteria used to make the decision to extubate the participant. Data are presented by TOF-ratio <0.9 and ≥0.9 at extubation. The TOF-ratio is a measure of neuromuscular function ranging from 0.0 to 1.0. The greater the T4/T1 ratio the greater~the recovery from neuromuscular blockade. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications."|From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)|Evaluable participants with TOF-ratio measurement at time of extubation and available procedure duration data. Three sugammadex participants with duration from end of surgery to extubation >1 hour were excluded from analysis; delay of extubation was considered due to factors unrelated to administration of sugammadex.||minutes||Standard Deviation|Mean
59606|NCT01213264|Primary|Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation|Neuromuscular function assessment was performed according to routine anesthesiology practice. This typically involves application of repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve and assessment of twitch response at the adductor pollicis muscle. The TOF-ratio, expressed as a decimal from 0.0 up to 1.0, is the ratio of the magnitude of the fourth twitch (T4) to that of the first twitch (T1). The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. The TOF-ratio was measured at the time of post-surgical extubation. TOF-ratio at time of extubation was to be recorded for each participant, if available, irrespective of the criteria used to make the decision to extubate the participant. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.|At extubation (approximately <1 to 125 minutes after end of surgery)|Evaluable participants with TOF-ratio measurement at time of extubation||participants|||Number
59607|NCT01213251|Secondary|Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.|"Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.~Variables resulting in statistical significant (p<0.05) are reported."|Baseline - 18 Month Follow Up Visit|All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.||regression coefficient||Standard Error|Mean
59608|NCT01213251|Secondary|Incidence of Sudden Cardiac Death and Total Mortality|"Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.~Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control."|18 Months post-randomization|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.||percentage of subjects at risk||95% Confidence Interval|Number
59609|NCT01213251|Secondary|Change in Quality of Life|"Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.~Change is defined as month 18 minus baseline.~Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control."|Baseline - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.||units on a scale||95% Confidence Interval|Mean
59610|NCT01213251|Secondary|Change in 6-minute Walk Test Distance|"Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.~Change is defined as month 18 minus baseline.~Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control."|1 Month - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.||meters||95% Confidence Interval|Mean
59611|NCT01213251|Secondary|Change in New York Heart Association (NYHA) Functional Class|"The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.~NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as “Improved”. Similarly for “Worsened” (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects’ NYHA Class is not different than baseline, then the subject was classified as No Change.~Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.||participants|||Number
59612|NCT01213251|Secondary|Frequency of Hospitalization for Cardiovascular Events|Number of hospitalizations related to cardiovascular events.|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.||participants|||Number
59613|NCT01213251|Secondary|Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events|Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.|18 months post-implant|Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.||survival probability||95% Confidence Interval|Number
59614|NCT01213251|Primary|Change in Left Ventricular End Diastolic Volume (LVEDV)|"Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV.~Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.||mL||95% Confidence Interval|Mean
59615|NCT01213199|Primary|Global Scarring Severity|"Grade Level:~Macular disease~Mild disease~Moderate disease~Severe disease"|Week 24|The analysis population includes 18 subjects whose data were available at this time frame (week 24).||units on a scale||Standard Deviation|Mean
59616|NCT01213173|Secondary|The Change From Baseline in Triglycerides|Difference of change from baseline in TG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.||mmol/L||95% Confidence Interval|Least Squares Mean
59617|NCT01213173|Secondary|The Change From Baseline in Fasting Plasma Glucose|Difference of change from baseline in FPG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.||mmol/L||95% Confidence Interval|Least Squares Mean
59618|NCT01213173|Secondary|The Change From Baseline in Total Cholesterol|Difference of change from baseline in TC after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.||mmol/L||95% Confidence Interval|Least Squares Mean
59619|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Attacks per week||95% Confidence Interval|Least Squares Mean
59620|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Attacks per week||95% Confidence Interval|Least Squares Mean
59621|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 8 weeks treatment.~Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||mm*min||95% Confidence Interval|Least Squares Mean
59622|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 2 weeks treatment.~Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||mm*min||95% Confidence Interval|Least Squares Mean
59623|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Participants|||Number
59624|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Participants|||Number
59625|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||95% Confidence Interval|Least Squares Mean
59626|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate Between Two Groups|Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||Standard Deviation|Mean
59627|NCT01213173|Secondary|The Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||95% Confidence Interval|Least Squares Mean
59807|NCT01211730|Primary|Rejection of Liver Transplant|Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications|within 1 year of transplantation|Patients undergoing liver transplant||participants|||Number
59628|NCT01213173|Primary|The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)|Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.||Bpm||Standard Deviation|Mean
59629|NCT01213043|Primary|Number of Treatment-Emergent Pulmonary Exacerbations|Total number of treatment-emergent pulmonary exacerbations.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||Events|||Number
59630|NCT01213043|Primary|Number of Drug-related TEAEs|Total number of drug-related TEAEs reported|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||Events|||Number
59631|NCT01213043|Primary|Number of TEAEs|Total number of TEAEs reported.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||Events|||Number
59632|NCT01213043|Secondary|Mean Trough|The average trough concentration at steady-state, calculated as the mean value using the four Trough measurements obtained at Weeks 6, 7, 8 and at 7 days (168 hours) post infusion at Week 8 for the first treatment period or prior to the start of the infusions at Weeks 16, 17, 18, and at 7 days (168 hours) post infusion at Week 18 for the second treatment period.|Single measurment immediately prior to infusion at Weeks 6, 7, 8, 9 and Weeks 16, 17, 18, 19|PK Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.||μM||Standard Deviation|Mean
59633|NCT01213043|Primary|Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s)|Number of subjects who experienced at least one severe TEAE or pulmonary exacerbation.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
59634|NCT01213043|Primary|Subjects With Treatment-Emergent Pulmonary Exacerbation(s)|Number of subjects with at least one treatment-emergent pulmonary exacerbation|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
59635|NCT01213043|Primary|Subjects Withdrawn Due to an AE(s)|Number of subjects who were withdrawn from the study due to at least one AE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
59636|NCT01213043|Primary|Subjects With Treatment-Emergent Serious Adverse Events (SAEs)|Number of subjects who experienced at least one treatment-emergent SAE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
59637|NCT01213043|Primary|Subjects With Drug-Related TEAE(s)|Number of subjects with at least one TEAE that was determined by the Investigator to be either “possibly related” or “related” to the investigational product (i.e., Prolastin-C).|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
59638|NCT01213043|Secondary|AUC0-7days|Area Under the Alpha-1 PI Concentration-Time Curve from Day 0 to Day 7|Week 8 and Week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose|Pharmacokinetic (PK) Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.||h*mg/mL||Standard Deviation|Mean
59639|NCT01213043|Primary|Subjects With Treatment-Emergent Adverse Events (TEAEs)|Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C).|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).||participants|||Number
59640|NCT01212991|Secondary|Best Overall Soft Tissue Response|The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.|During study period (up to 3 years)|Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.||Percentage of participants|||Number
59641|NCT01212991|Secondary|Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%|PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.|During study period (up to 3 years)|Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.||Percentage of Participants||95% Confidence Interval|Number
59739|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59642|NCT01212991|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomized.||months||95% Confidence Interval|Median
59643|NCT01212991|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.||months||95% Confidence Interval|Median
59644|NCT01212991|Secondary|Time to First Skeletal-related Event|Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.||months||95% Confidence Interval|Median
59645|NCT01212991|Primary|Radiographic Progression-free Survival|Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.|During study period (up to 20 months)|Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.||months||95% Confidence Interval|Median
59646|NCT01212991|Primary|Overall Survival|Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.||months||95% Confidence Interval|Median
59647|NCT01212874|Secondary|Title: Systolic Hypertension|Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Duration: during infusion of study drug|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.||mmHg*min / prebypass hour||95% Confidence Interval|Median
59648|NCT01212874|Primary|Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour|Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Participation could last up to 2 weeks, representing the day of surgery until discharge from the hospital.|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.||mmHg*min/prebypass hour||95% Confidence Interval|Median
59649|NCT01212770|Secondary|Number of Participants With Adverse Events||Up to 5 years||12/2017||||
59650|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59779|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
59651|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59652|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59653|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59654|NCT01212770|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants|||Number
59655|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59656|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59657|NCT01212770|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59808|NCT01211665|Primary|Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent||Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
94431|NCT00860470|Secondary|Neonatal Mortality|Risk of neonatal Mortality (28 days of life)|Dec 2014|||participants|||Number
59658|NCT01212770|Secondary|Change From Baseline in the DAS28 at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59659|NCT01212770|Secondary|Change From Baseline in the CDAI Score at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59660|NCT01212770|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59661|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59662|NCT01212770|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||mm||Standard Deviation|Mean
59663|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52|"The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks.~The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with Baseline Psoriasis Body Surface Area ≥ 3% and a Week 52 value are included.||percentage of participants||95% Confidence Interval|Number
59664|NCT01212770|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59665|NCT01212770|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
68301|NCT01125098|Secondary|Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations.||Discharge /10 days-6 months||||||
59666|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59667|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59668|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59669|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59670|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59671|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59672|NCT01212770|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
61200|NCT01195090|Secondary|Change in Fasting Plasma Alanine-aminotransferase (ALT)|ALT change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||IU/L||Standard Error|Least Squares Mean
59673|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59674|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59675|NCT01212770|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59676|NCT01212770|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59677|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59678|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59679|NCT01212770|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59809|NCT01211665|Primary|Time Course Change in Clinical Laboratory Values|Clinical laboratory values included chemokines, cytokines, C-reactive protein (CRP), John Cunningham (JC) virus load, and cell count in cerebrospinal fluid.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
59680|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59681|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59682|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59683|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59684|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59685|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59686|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59687|NCT01212770|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
59688|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24|"The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment.~The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Week 24|Full analysis set; participants with baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59689|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59690|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59691|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59692|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59693|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59694|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59780|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.~trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||units on a scale||Inter-Quartile Range|Median
59695|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59696|NCT01212770|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
59697|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16|"The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment.~The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Week 16|Full analysis set; participants with a baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59698|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59699|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59700|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59701|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59781|NCT01212094|Secondary|EDSS|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|0 months|||units on a scale||Inter-Quartile Range|Mean
67982|NCT01128179|Secondary|Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)||12 weeks|PP||percentage of excretion of phosphate||Standard Error|Least Squares Mean
59702|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
59703|NCT01212770|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59704|NCT01212757|Secondary|Number of Participants With Adverse Events||Up to 5 years||12/2017||||
59705|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59706|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59707|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59708|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59709|NCT01212757|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants|||Number
59710|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59711|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59712|NCT01212757|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59713|NCT01212757|Secondary|Change From Baseline in the DAS28 at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59714|NCT01212757|Secondary|Change From Baseline in the CDAI Score at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59715|NCT01212757|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59716|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59717|NCT01212757|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||mm||Standard Deviation|Mean
59782|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||Z score||Inter-Quartile Range|Median
67983|NCT01128179|Secondary|Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)||12 weeks|PP||pg/ml||Standard Error|Least Squares Mean
59718|NCT01212757|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59719|NCT01212757|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59720|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
59721|NCT01212757|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
59722|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59723|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59724|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
67984|NCT01128179|Secondary|Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)||12 Weeks|PP||pg/ml||Standard Error|Least Squares Mean
59725|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59726|NCT01212757|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59727|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59728|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59729|NCT01212757|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59730|NCT01212757|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59731|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59800|NCT01211769|Secondary|Short Alcohol Dependence Data Questionnaire (SADD)|The Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.|3 months|||Units on a Scale||Standard Deviation|Mean
59732|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59733|NCT01212757|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59734|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59735|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59736|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59737|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59738|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59801|NCT01211769|Primary|"Drinking Days in the Previous Month"|The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.|3 months|||Days||Standard Deviation|Mean
59740|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59741|NCT01212757|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
59742|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59743|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59744|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means “not at all,” and 4 means “very much.” The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59745|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59746|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59747|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59802|NCT01211730|Secondary|Death Within 1 Year|Death following liver transplant between 1 day and 1 year|1 year|||participants|||Number
59748|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59749|NCT01212757|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents “no pain,” and the right-hand boundary (score = 100 mm) represents “pain as severe as can be imagined.” The distance from the mark to the left-hand boundary was recorded in millimeters.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
59750|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59751|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
59752|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
59753|NCT01212757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
59754|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
59784|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
59755|NCT01212757|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
59756|NCT01212627|Secondary|Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus.|the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin|1 year||||||
59757|NCT01212627|Primary|Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab|"the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin~Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day"|1 year|||mg/day|||Number
59758|NCT01212484|Primary|24 Hour Dopamine Levels|Assay of 24 hour dopamine level excretion in urine|4 weeks|||ug/gCR||Standard Deviation|Mean
59759|NCT01212484|Secondary|Number of Episodes of Daily Nausea||4 weeks|||episodes of nausea||Standard Deviation|Mean
59760|NCT01212484|Primary|Composite Daily Score|Daily scores were reported on a modified version of the Rhodes Index of Nausea, Vomiting and Retching, which included all 5 items relating to nausea and retching. Items addressing vomiting/throwing up were omitted, as all participants had antireflux surgery that prevented vomiting (Nissen fundoplication). Retching distress, nausea distress, number of nausea episodes per day, number of retching episodes per day, and the amount of time spent feeling nauseous were graded on a 5-point scale. Scores range from 0 (no nausea/distress) to 20 (most nausea/distress).|4 weeks|||units on a scale||Standard Deviation|Mean
59761|NCT01212445|Secondary|Mean Participant Global Assessment of Treatment|At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.|From time of study drug administration up to 2 Days|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.||units on a scale||Standard Deviation|Mean
59762|NCT01212445|Secondary|Mean VAS Rating for Abdominal Discomfort/Cramping|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
59763|NCT01212445|Secondary|Mean VAS Rating for Bloating|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
59764|NCT01212445|Secondary|Mean VAS Rating for Gas|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
59783|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
59803|NCT01211730|Secondary|Overall Graft Survival at 1 Year||1 year following transplantation|||participants|||Number
59765|NCT01212445|Secondary|Mean Visual Analog Scale (VAS) Rating for BM Control|"The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group"|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.||mm||Standard Deviation|Mean
59766|NCT01212445|Secondary|Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 12 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.||percentage of participants|||Number
59767|NCT01212445|Secondary|Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration|Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).|From time of study drug administration up to 3 Days|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had a successful bowel movement (no straining or hard/lumpy stools). Participants who reported no successful BMs were censored.||participants|||Number
59768|NCT01212445|Primary|Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 24 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.||percentage of participants|||Number
59769|NCT01212302|Primary|Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)|"In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.~The following definitions were used for clopidogrel low response (CLR: >5 ohm when stimulated with adenosine diphosphate (ADP) 5 μM) and ASA low response (ALR: >0 ohm;stimulated with arachidonic acid 10 μM) with the ChronoLog 590 aggregometer. In the case of low-response alternative antiplatelet therapy was modified according to the study plan (see protocol section)."|2 years|Sample size calculation: With the assumption that the incidence of clopidogrel low response was at least 20% and ASA low response 10%. Choosing a power of 97.5% and a two-sided value of 0.05, an overall sample size was required of at least 400 patients. To compensate for a possible loss of follow-up, we aimed for inclusion of approx. 500 patients.||participants||95% Confidence Interval|Number
59770|NCT01212185|Secondary|CIWA-Ar Scores|Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77.|days 1|||units on a scale||Standard Deviation|Mean
59771|NCT01212185|Primary|Total Lorazepam Dosage (in Milligrams)|Total lorazepam (in milligrams) required per subject to complete detoxification|Days 1 to 5|||milligrams of lorazepam||Standard Deviation|Mean
59772|NCT01212172|Secondary|Pain Rating Scale|Pain during each treatment was measured subjectively by patients on a 0–10 visual analogue scale (0=no pain, 10=unbearable pain).|12 months|||Units on a Scale||95% Confidence Interval|Median
59773|NCT01212172|Primary|Change in Hair Growth|% reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]|1 month, 6 month, 12 month|||% hair reduction||Standard Deviation|Mean
59774|NCT01212159|Secondary|LDL Values at Two Week Interval|Participant in the self monitored arm reported LDL every two weeks. LDL goal for treatment was 100 mg/dl and subjects were followed every two weeks to observe mean LDL values.|6 weeks|No self monitoring group had LDL levels only at baseline and 6 months.||mg/dl||Standard Deviation|Mean
59775|NCT01212159|Secondary|Medication Compliance|Self reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4.|6 months|||units on a scale||Standard Deviation|Mean
59776|NCT01212159|Primary|LDL Level Change From Baseline|Comparison of serum LDL level between control and intervention subjects|baseline to 6 months|||mg/dl||Standard Deviation|Mean
59777|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||Z score||Inter-Quartile Range|Median
59778|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||seconds||Inter-Quartile Range|Median
59804|NCT01211730|Secondary|Rehospitalization Rates||Within 1 year following transplantation|patients undergoing liver transplant||participants|||Number
59805|NCT01211730|Secondary|Infection Rates||Within 1 year following transplantation|patients having had liver transplants||participants|||Number
59785|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.~trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.||units on a scale||Inter-Quartile Range|Median
59786|NCT01212094|Secondary|Expanded Disability Status Scale (EDSS)|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility||units on a scale||Inter-Quartile Range|Median
59787|NCT01212094|Primary|Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of B-cell activating factor (BAFF) before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. BAFF is consumed by B cells, therefore effective B cell depletion increases levels of BAFF. The protocol-stipulated threshold for trial continuation was at least 50% increase in CSF BAFF induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug.||percentage of BAFF change||Inter-Quartile Range|Median
59788|NCT01212094|Primary|Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of chemokine CXCL13 before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. CXCL13 is released by activated B cells, T cells and by follicular dendritic cells and has been linked previously with MS inflammation in the brain and spinal cord. The protocol-stipulated threshold for trial continuation was at least 25% decrease in CSF CXCL13 induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug||percentage of b cell depletion||Inter-Quartile Range|Median
59789|NCT01212094|Secondary|Analysis of Changes in CSF B Cell Numbers Between Rituximab and Placebo|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares absolute numbers of CSF B cells calculated as proportion of B cells (identified from flow cytometry data) in all immune cells measured in 50-fold concentrated CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing.|3 months|These patients were analyzed for the interim analysis for the efficacy of B cell depletion. Trial stipulated stopping criteria for futility.||percentage of b cell depletion||Inter-Quartile Range|Median
59790|NCT01211873|Secondary|Measure Blood Sample.||up to 24 hours||||||
59791|NCT01211873|Secondary|Injection-site Tolerance on the Visual Analog Scale From 0 (no Pain) to 10 (Maximal Pain).||up to 24 hours||||||
59792|NCT01211873|Secondary|Measure ECG||up to 24 hours||||||
59793|NCT01211873|Secondary|Measure Vital Signs (Supine Systolic and Diastolic Blood Pressures, Pulse).||up to 24 hours||||||
59794|NCT01211873|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability.||up to 29 days||||||
59795|NCT01211873|Secondary|Number of Lesions With MRI Signal Intensity Changes After Contrast Agent Injection.||up to 24 hours as the safety is assessed till 24 hours after injection||||||
59796|NCT01211873|Secondary|Level of Diagnostic Confidence on 5-point Scale Ranging From Nil to Excellent With Poor, Moderate and High as Intermediate Grades.||up to 24 hours as the safety is assessed till 24 hours after injection||||||
59797|NCT01211873|Secondary|The Quality of Images on 3-point Scale: Poor, Fair or Good.||up to 24 hours as the safety is assessed till 24 hours after injection||||||
59798|NCT01211873|Primary|"MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both Pre and Paired Evaluation, Each Lesion is Scored With 3-point Scales."|"To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.~Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. Pre refers to unenhanced MRI. PAIRED refer to combined unenhanced and enhanced MRI.~The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0."|up to 24 hours as the safety is assessed till 24 hours after injection|The primary analysis was performed at the patient level using off-site readings by 3 readers. The number of participants for analysis depended on the number of evaluable cases (pre and paired)determinted by each reader. Only adult participants included in this data set.||units on a scale||Standard Deviation|Mean
59799|NCT01211769|Secondary|Obsessive Compulsive Drinking Scale (OCDS)|The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 – 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.|3 months|||Units on a Scale||Standard Deviation|Mean
59806|NCT01211730|Secondary|Hypoglycemia|Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation|Within first 3 days following transplantation|Patients having liver transplant||participants|||Number
59810|NCT01211665|Primary|Time Course Change in Magnetoencephalography (MEG) Results|MEG was used to map brain activity.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; no data on this endpoint was collected.|||||
59811|NCT01211665|Primary|Time Course Changes in Brain Magnetic Resonance Imaging (MRI)|The brain MRI data collected included: progressive multifocal leukoencephalopathy (PML) lesion localization, T2 hyperintense lesion volume, and signs of cerebral edema.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
59812|NCT01211665|Primary|Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT)|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
59813|NCT01211665|Primary|Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale|The GCI-I scale is a 7-point scale that assesses how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rates it as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Screening to 6 months following completion of PLEX (participants began treatment with intravenous methylprednisolone (IVMP) within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
59814|NCT01211665|Primary|Severity of AEs and SAEs|AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant’s daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period|||events|||Number
59815|NCT01211665|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period|||participants|||Number
59816|NCT01211665|Primary|Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)|Following the completion of rapid removal of natalizumab using PLEX or equivalent.|6 months|||participants|||Number
59817|NCT01211665|Primary|Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)|The Karnofsky Performance Status Index (KPSI) is an assessment tool intended to assist clinicians and caretakers in gauging a patient's functional status and ability to carry out activities of daily living. A KPSI of 100=normal, no complaints, no evidence of disease; 90=able to carry on normal activity, minor signs or symptoms of disease; 80=normal activity with effort, some signs or symptoms of disease; 70=cares for self, unable to carry on normal activity or do active work; 60=requires occasional assistance but is able to care for most personal needs; 50=requires considerable assistance and frequent medical care; 40=disabled, requires special care and assistance; 30=severely disabled, hospitalization is indicated, although death is not imminent; 20=very sick, hospitalization is necessary, active support treatment is necessary; 10=moribund, fatal processes progressing rapidly; 0=dead.|Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.|||||
59818|NCT01211613|Secondary|Numeric Pain Rating Score.|Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating “no pain” and 10 indicating “unbearable pain”. Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment).|4 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
59819|NCT01211613|Primary|Oswestry Low Back Pain Disability Index|The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).|4 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
59910|NCT01210118|Primary|The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.|The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.|At the baseline and at the 32nd week of gestation|||percentage of participants who quit|||Number
59820|NCT01211535|Primary|Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, how your eyes feel right now. A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort."|Baseline (Day 0), Day 14|All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)||Units on a scale||95% Confidence Interval|Least Squares Mean
59821|NCT01211197|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|Drug administration up to 7 days after last drug administration, up to 8 days|Treated set (TS) includes all subjects who took at least 1 dose of investigational medication and was used for safety analysis.||participants|||Number
59822|NCT01211197|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||Litres||Standard Deviation|Mean
59823|NCT01211197|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of the analyte in the plasma after extravascular administration.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||mL/min||Standard Deviation|Mean
59824|NCT01211197|Secondary|Mean Residence Time in the Body After Oral Administration (MRTpo)|"Mean residence time of the analyte in the body after oral administration.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||hours||Standard Deviation|Mean
59825|NCT01211197|Secondary|Terminal Half-life in Plasma (T1/2)|"Terminal half-life of the analyte in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||hours||Standard Deviation|Mean
59826|NCT01211197|Secondary|Terminal Elimination Rate Constant in Plasma (λz)|"Terminal elimination rate constant in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||1/h||Standard Deviation|Mean
59827|NCT01211197|Secondary|Time to Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum concentration of the analyte in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||hours||Full Range|Median
59828|NCT01211197|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of metformin in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||ng/mL||Standard Deviation|Mean
59829|NCT01211197|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||ng*h/mL||Standard Deviation|Mean
59830|NCT01211197|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||ng*h/mL||Standard Deviation|Mean
63564|NCT01175018|Secondary|Incidence of Heart Failure|Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure|10-14 weeks|||participants|||Number
59831|NCT01211197|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||nmol*h/L||Standard Deviation|Mean
59832|NCT01211197|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||nmol/L||Standard Deviation|Mean
59833|NCT01211197|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the coefficient of variation (CV)."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.||nmol*h/L||Standard Deviation|Mean
59834|NCT01211184|Secondary|Muscle Catabolism|Assessed by the ratio of 3-methylhistidine/creatinine in excreted urine (unit: mmol/mmol).This is an amino acid unique to muscle that does not undergo intermediary metabolism, meaning that its urinary excretion is an index of the degree of muscle catabolism.|From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)|Per protocol||mmol/mmol||Standard Deviation|Mean
59835|NCT01211184|Primary|Change in Insulin Sensitivity (Percent)|Insulin sensitivity (micro-mol per kg per minute glucose uptake) was calculated based on an intravenous glucose tolerance test (Theor Biol Med Model 2011, 8: 12) on the day before surgery. The percent change was taken as (day after - day before) / day before|Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).|Per protocol analysis. The study was powered to detect a difference in glucose clearance.||percent change of insulin sensitivity||Inter-Quartile Range|Median
59836|NCT01211145|Secondary|Use of Rescue Medication During the First 24 Hours After Treatment||24 hours post-treatment.|Full analysis set (observed cases)||Participants|||Number
59837|NCT01211145|Secondary|Sustained Headache Response at 2 Hours|Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.|Up to 2 hours post-treatment|Full analysis set (observed case)||Participants|||Number
59838|NCT01211145|Secondary|Headache Response at 24 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|24 hours post-treatment|Full analysis set (observed case)||Participants|||Number
59839|NCT01211145|Secondary|Headache Response at 2 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|2 hours post-treatment|Full analysis set (last observation carried forward)||Participants|||Number
59840|NCT01211145|Secondary|Pain-free Status at 24 Hours Post-treatment||24 hours post-treatment|Full analysis set (observed case)||Participants|||Number
59841|NCT01211145|Primary|Pain-free Status at 2 Hours Post-treatment||2 hours post-treatment.|Full analysis set (last observation carried forward)||Participants|||Number
59842|NCT01210820|Primary|Change in Keratometric Cylinder|Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.|6 Months|||Diopters of astigmatism change||Standard Deviation|Mean
59843|NCT01210820|Primary|Change in Refractive Astigmatism|Change in mean cylinder (assessed by manifest refraction) compared to baseline.|6 months|||Diopter of cylinder change||Standard Deviation|Mean
59844|NCT01210807|Primary|Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm|Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.|4-6 Months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.||logMAR visual acuity||Standard Deviation|Mean
59845|NCT01210807|Secondary|Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity||4-6 months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.||participants|||Number
59846|NCT01210716|Secondary|Safety Measured by Adverse Events During the TPE Procedure||Adverse events were collected during each TPE procedure.|Adverse events were summarized for enrolled subjects per protocol. 7 out of 37 enrolled subjects experienced adverse events during the study with a total of 12 adverse events reported.||participants|||Number
59911|NCT01210118|Secondary|Birth Weight|Infants' birth weight was recorded.|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.||birth weight in grams||Standard Deviation|Mean
63565|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks||10-14 weeks|||ml*kg^-1*min^-1||Inter-Quartile Range|Median
59847|NCT01210716|Primary|Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure|"The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure.~Plasma Efficiency = (plasma removed/plasma processed)*100"|After completion of the TPE procedure.|A total of 37 patients who consented and enrolled started the 1st procedure. Of these 37 patients, 33 patients completed the 1st procedure and started a 2nd procedure. Three patients did not complete the second procedure resulting in 30 patients with completed paired Test and Control procedures.||percentage of plasma removal efficiency||Full Range|Mean
59848|NCT01210690|Secondary|Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period|Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment.||participants|||Number
59849|NCT01210690|Secondary|Global Evaluation Scale of Epilepsy Severity (GES)|"Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options:~7=Marked improvement~6=Moderate improvement~5=Slight improvement~4=No Change~3=Slight worsening~2=Moderate worsening~1=Marked worsening~As a variant of this variable, a 3-class variable was derived as follows~“Marked improvement,” “Moderate improvement,” and “Slight improvement” were defined as “Improved.”~“No change” was defined as “Stable.”~“Slight worsening,” “Moderate worsening,” and “Marked worsening” were defined as “Worsened.”"|From Baseline to the last Treatment Visit (maximum time frame is 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.||participants|||Number
59850|NCT01210690|Secondary|Global Evaluation Scale of the Psychomotor Development (GES)|"Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options:~7=Marked improvement~6=Moderate improvement~5=Slight improvement~4=No Change~3=Slight worsening~2=Moderate worsening~1=Marked worsening~As a variant of this variable, a 3-class variable was derived as follows~“Marked improvement,” “Moderate improvement,” and “Slight improvement” were defined as “Improved.”~“No change” was defined as “Stable.”~“Slight worsening,” “Moderate worsening,” and “Marked worsening” were defined as “Worsened.”"|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.||participants|||Number
59851|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit|The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.|From Baseline to the last Treatment Visit (maximum 12 months)||||||
59852|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit|"Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs).~The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs."|From Baseline to the last Treatment Visit (maximum 12 months)||||||
59853|NCT01210690|Secondary|Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit|For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||z-scores||Standard Deviation|Mean
59854|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit|For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||z-scores||Standard Deviation|Mean
59855|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit|For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.|From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||z-scores||Standard Deviation|Mean
59872|NCT01210495|Secondary|Time to Deterioration (TTD) Based on the Composite Endpoint in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|A time to deterioration (TTD) analysis was performed for FHSI-8. Time to deterioration was defined as the time between date of randomization and date of the event.|From randomization to death or tumor progression or FHSI-8 mean score decrease >=3 points, whichever comes first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
59856|NCT01210690|Secondary|Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit|Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months). The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient. The evaluation of the patient’s psychomotor development was categorized by the motor development, the social development and the language development.|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication. Presented is the number of subjects with non-missing data on psychomotor development at the corresponding visit.||participants|||Number
59857|NCT01210690|Secondary|Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||participants|||Number
59858|NCT01210690|Secondary|Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up|Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||participants|||Number
59859|NCT01210690|Primary|Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.||participants|||Number
59860|NCT01210651|Secondary|Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers|The Rosenberg Self-Esteem Scale (RSES) is a 10-item, self-administered, validated psychometric instrument to measure self-esteem, defined as having an overall feeling of self-worth and self-acceptance. Each item is scored from 0 to 3, and individual item scores are summed to yield a total possible RSES ranging from 0-30. RSES scores from 0-14 suggest low self-esteem, from 15-25 normal self-esteem, and from 26-30 high self-esteem. RSES scores of study completers were examined, and the total change score on RSES was calculated for each intervention group as the mean RSES score at 0 wks subtracted from the mean RSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.||points on a scale||Standard Deviation|Mean
59861|NCT01210651|Secondary|Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers|The General Self-Efficacy Scale (GSES) is a 10-item, self-administered, validated psychometric instrument to measure self-efficacy, defined as the belief that one’s actions are responsible for successful outcomes in coping with difficult life demands. Each item is scored from 1 to 4, with a total GSES score derived by summing the individual item scores. Possible GSES scores range from 10 (no belief in one's self-efficacy) to 40 (strongest belief in one’s self-efficacy). GSES scores of study completers were examined, and the total change score on GSES was calculated for each intervention group as the mean GSES score at 0 wks subtracted from the mean GSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.||points on a scale||Standard Deviation|Mean
59862|NCT01210651|Primary|Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Analysis examined BDI scores of study completers and identified in each intervention group the number of participants with an 8-wk BDI score ≤ 9, defined as remitted depression.|8 Weeks|Population of study completers with remitted depression was comprised of participants in both intervention groups who provided study measures at 0 wks and 8 wks, and achieved an 8-wk BDI score ≤ 9.||participants|||Number
59863|NCT01210651|Primary|Total Change Scores on Beck Depression Inventory-II Among Study Completers|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. BDI scores of study completers were examined, and the total change score on BDI was calculated for each intervention group as the mean BDI score at 0 wks subtracted from the mean BDI score at 8 wks.|0 wks and 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention end at 8 wks.||points on a scale||Standard Deviation|Mean
59888|NCT01210495|Secondary|Duration of Response (DR) by Unstratified Analysis, Randomized Portion|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was to be used. DR (in months) was to be calculated as (the end date for DR − first CR or PR that was subsequently confirmed +1)/30.4.|From objective response to date of progression or death|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received. DR was calculated for the subgroup of FAS participants with objective response.||Months||95% Confidence Interval|Median
63566|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)||10-14 weeks|||% of participants|||Number
59864|NCT01210651|Primary|Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Regression analysis software examined the BDI scores measured in study participants every 2 wks from intervention start at 0 wks until intervention end at 8 wks, using maximum likelihood estimations to derive an adjusted mean BDI score for each intervention group at each measurement point.|0 wks, 2 wks, 4 wks, 6 wks, 8 wks|Intent-to-Treat population was comprised of all randomized participants in both intervention groups, regardless of adherence to protocol or premature dropout. BDI scores of any participants missing at 0 wks were imputed by carrying forward their BDI scores from screening.||points on a scale||95% Confidence Interval|Least Squares Mean
59865|NCT01210495|Secondary|Number of Participants With Treatment-related AEs in Randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
59866|NCT01210495|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs) in Randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
59867|NCT01210495|Secondary|Number of Participants With Treatment-related AEs in Non-randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
59868|NCT01210495|Secondary|Number of Participants With Treatment-emergent AEs in Non-randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Up to 28 days after last dose of study drug, for up to 3 years|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.||Participants|||Number
59869|NCT01210495|Secondary|Number of Participants With Dose-limiting Toxicities (DLTs) in Non-randomized Portion|Number of Child-Pugh Class B (score 7) participants with DLT was evaluated during Cycle 1 of treatment in the non-randomized portion of the study.|Cycle 1 (4 weeks)|Participants with Child-Pugh Class B, score 7 are only included in this analysis.||Participants|||Number
59870|NCT01210495|Secondary|EQ-VAS in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59871|NCT01210495|Secondary|EuroQoL (EQ-5D)- Health State Profile Utility Score in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59912|NCT01210118|Primary|Participants' Smoking Status|participants' smoking status was validated by urine cotinine and urine nicotine|around the 32nd week of gestation.|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis||ng/ml||Standard Deviation|Mean
59873|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Trial Outcome Index (FACT Hep-TOI) Questionnaire in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|The trial outcome index is defined to be the sum (PWB+FWB+HepCS), making it 32 items altogether. Each ranges from '0' – not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT Hep –TOI total score ranges from 0 to 128, where the highest score represents a maximum achievable quality of life. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59874|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Subscale (FACT Hep-CS18) Questionnaire in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|This subscale consists of 18 items rated on a scale from ‘0’ - not at all to ‘4’ - very much regarding how much each item was present in the last 7 days. FACT-Hep-CS18 total score ranges from 0 to 72. The higher score reflects better quality of life or fewer symptoms. The 18 items of this scale are associated with hepatocellular carcinoma. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59875|NCT01210495|Secondary|FACT-G Subscales in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB) , Emotional Well-Being (EWB) and Functional Well-Being (FWB). Each of the individual subscale, except EWB has 7 items and each integer scored 0 to 4 making a maximum possible score of 28 (range 0 to 28). EWB has 6 items and each integer scored 0 to 4 making a maximum possible score of 24 (range 0 to 24). For all the 4 scales, higher values correspond to better health. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59876|NCT01210495|Secondary|FHSI-8 in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|The FACT-Hep includes the FACT-G and a hepatobiliary module. The Hepatobiliary disease specific items include: swelling or cramps, losing weight, GI related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss, and jaundice) make up the FHSI-8, and are considered to be symptoms specific to hepatobiliary cancer. FHSI-8 total score ranges from 0 to 32 where “0” is a severely symptomatic participant and the highest score indicates an asymptomatic participant. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59877|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - General (FACT-G) in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much). FACT-G ranged between 0 and 108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59887|NCT01210495|Secondary|Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion|CBR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease ≥8 weeks according to RECIST criteria, relative to all randomized participants who had baseline measurable disease. Confirmed responses were defined as those that persisted on repeat imaging study ≥4 weeks after the initial documentation of response. Participants who did not have on study radiographic tumor re evaluation or who died, progressed, or dropped out for any reason prior to reaching a CR, PR, or stable disease were counted as non-responders in the assessment of CBR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR was to be assigned a best response of CR.|From Baseline up to end of treatment|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
61201|NCT01195090|Secondary|Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)|HDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
59878|NCT01210495|Secondary|Functional Assessment of Cancer Therapy – Hepatobiliary Questionnaire (FACT-Hep) in Randomized Portion: Overall Between-treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-Hep consists of 27-item FACT-G, and 18-item Hepatobiliary Subscale. FACT-Hep questionnaire uses 5-point Likert rating scale, range '0'-not at all to '4'. FACT-Hep total score ranges from 0 to 180, where highest score represents maximum achievable quality of life. Domains of FACT-G include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Hepatobiliary disease specific items include: swelling or cramps, losing weight, gastrointestinal-related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss and jaundice) make up FACT-Hepatobiliary Symptom Index (FHSI-8), and are considered to be symptoms specific to hepatobiliary cancer. Table below included mixed effect model estimated average based on all observed values/time points.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Units on a scale||95% Confidence Interval|Least Squares Mean
59879|NCT01210495|Secondary|Percentage of Participants With Specific miRNA Transcript Present in Circulation in Randomized Portion|A 5 mL whole blood sample was collected from all randomized participants to evaluate the miRNA transcripts.|Baseline|The miRNA analysis set included all participants in the safety analysis set who had a baseline miRNA assessment.||Percentage of participants|||Number
59880|NCT01210495|Secondary|Concentration of Soluble Proteins at Baseline in Randomized Portion|Plasma soluble proteins IL-6, E-Selectin, IL-8, HGF, MMP-2, SCF, Ang-2, VEGF-A, VEGF-C, sVEGFR2, sVEGFR3, SDF1, NGAL, MIF, c-MET, RANTES, and MCP-3 were only measured in randomized participants.|Baseline|The soluble protein analysis set included all participants in the safety analysis set who had a Baseline soluble protein assessment.||pg/mL||Standard Deviation|Mean
59881|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Apparent Oral Volume of Distribution of the Drug During the Elimination Phase (Vz/F), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. The PK parameter, Vz/F has been presented in this outcome measure. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||Liter||95% Confidence Interval|Geometric Mean
59882|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Terminal Plasma Elimination Half-life (t1/2), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||Hour||Standard Deviation|Mean
59883|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Apparent Oral Clearance (CL/F), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||L/hr||95% Confidence Interval|Geometric Mean
59884|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic Parameter - Time to First Occurrence of Cmax (Tmax), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||Hour||Full Range|Median
59885|NCT01210495|Secondary|Axitinib Steady-state PK Parameter - Area Under the Plasma Concentration Versus Time Curve From 0 to 24 hr (AUC0-24), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng*hr/mL||95% Confidence Interval|Geometric Mean
59886|NCT01210495|Secondary|Axitinib Steady-state Pharmacokinetic (PK) Parameter - Maximum Observed Plasma Concentration (Cmax), Non-randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng/mL||95% Confidence Interval|Geometric Mean
59889|NCT01210495|Secondary|Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion|TTP was defined as the time from randomization to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − first randomization date +1)/30.4.|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
59890|NCT01210495|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion.|ORR was defined as the percent of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Every 8 weeks until at least two years after the last participant has been randomized|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
59891|NCT01210495|Secondary|Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion|"PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date − first randomization date +1)/30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was Death). As per RECIST 1.1, progression was defined as ≥20% increase in the sum of the longest dimensions of the target lesions or the appearance of one or more new target lesions and unequivocal progression of existing non-target lesions, or the appearance of 1 new non-target lesions. Participants discontinuing study treatment without documented evidence of disease progression were to be followed up at least every 8 weeks after discontinuing study treatment until disease progression, or initiation of another anticancer treatment, whichever was earlier."|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
59892|NCT01210495|Primary|Overall Survival (OS) - Stratified Analysis, Randomized Portion|OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.|From randomization until at least two years after the last participant has been randomized|The full analysis set (FAS) included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
59893|NCT01210443|Secondary|Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||pg/mL||Standard Deviation|Mean
59894|NCT01210443|Secondary|Percentage of Participants With Change From Baseline in WHO Functional Class|The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||Parcentage of participants|||Number
59895|NCT01210443|Secondary|Change From Baseline in 6-Minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||Meters||Standard Deviation|Mean
59896|NCT01210443|Secondary|Percentage of Participants With Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."||Percentage of participants|||Number
59897|NCT01210443|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|Up to 22 days (last participant discontinuation)|The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study.||Participants|||Number
59898|NCT01210170|Secondary|Albuterol Induced Percent Change in Qaw|Qaw will be measured before and 15 min after albuterol inhalation|change in Qaw 15 minutes after albuterol inhalation|||percent change in Qaw||Standard Error|Mean
59899|NCT01210170|Primary|Albuterol-induced Change in FEV1|FEV1 will be measured before and after inhalation of 180 mcg albuterol.|15 minutes after albuterol inhalation|||liters||Standard Error|Mean
59909|NCT01210118|Secondary|Days of Prematurity of Birth|Days of prematurity of birth were recorded|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.||number of days||Standard Deviation|Mean
73799|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
59900|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase). Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data for histological pattern of the endometrium in participants with good or poor response to Gonal-f were not summarized because the number of participants in each group with respect to ovarian response were too low.|||||
59901|NCT01210144|Secondary|Gene Expression in Participants With Good or Poor Response to Gonal-f®|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent. Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
59902|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day 5 or 6 (window of implantation) after Oocyte Retrieval|"ITT population: participants who received at least one dose of study medication. N (number of participants analyzed) signifies participants who were evaluable for this measure. Data were not analyzed for Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) group because there were no participants without blastocyst transfer in this group."||participants|||Number
59903|NCT01210144|Secondary|Gene Expression in Participants Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day 5 or 6 (window of implantation) after Oocyte Retrieval|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
59904|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"ITT population included those participants who received at least one dose of study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."||participants|||Number
59905|NCT01210144|Secondary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
59906|NCT01210144|Secondary|Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
59907|NCT01210144|Primary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"Intention-to-Treat (ITT) population: participants who received at least 1 dose of study drug. N (number of participants analyzed) signifies participants evaluable for this measure. Results for both agonist and antagonist protocol are presented as total since assessment of histological pattern for whole study population was the primary objective."||participants|||Number
59908|NCT01210144|Primary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®|A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed for both agonist and antagonist protocol as total, which was the primary objective, since gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.|||||
61202|NCT01195090|Secondary|Change in Fasting Triglycerides(TG)|TG change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
59913|NCT01210079|Primary|Change in Pain Threshold Time From Baseline to Week 5|Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.|baseline, 5 weeks|||seconds||Standard Error|Mean
59914|NCT01210001|Other Pre-specified|Hypoglycaemic Events|Number of patients with hypoglycaemic events, as reported as adverse events.|From first drug administration until 7 days after last intake of study drug, up to 256 days|Treated set which included all patients treated with at least one dose of randomised study medication||percentage of participants|||Number
59915|NCT01210001|Primary|HbA1c Change From Baseline for Pio and Met Background Medication Patients|"Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value for patients on pioglitazone and metformin background medication. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
59916|NCT01210001|Secondary|Body Weight Change From Baseline|"Change from baseline in body weight after 24 weeks.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||kg||Standard Error|Mean
59917|NCT01210001|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|"Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mg/dL||Standard Error|Mean
59918|NCT01210001|Primary|HbA1c Change From Baseline|"Change From Baseline in HbA1c after 24 weeks.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
59919|NCT01209949|Secondary|Number of Participants With Tolerability Assessments Resulting in an Adverse Event|Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.|12 weeks|Safety||participants|||Number
59920|NCT01209949|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.|Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.|Week 12|Modified ITT (subjects with a baseline and week 12 visit)||percent change from baseline||Standard Deviation|Mean
59921|NCT01209949|Primary|Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12|Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.|12 weeks|Modified ITT (subjects with a baseline and week 12 visit)||participants|||Number
59922|NCT01209780|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.|Day 1 to 180 (non-naive )/Day 1 to 209 (naive)|Analysis was done on the safety set population.||Subjects|||Number
59923|NCT01209780|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.|Day 1 to 7 after vaccination|Analysis was done on the safety set population i.e all subjects who received at least one study vaccine and provided post vaccination safety data.||Subjects|||Number
59924|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).~This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain."|Day 29 and Day 50|Analysis was done on the per protocol population.||Percentages of subjects||95% Confidence Interval|Number
59925|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.|"The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).~This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain."|Day 1, Day 29, and Day 50|Analysis was done on the per protocol population.||Percentages of subjects||95% Confidence Interval|Number
59936|NCT01209702|Secondary|Change From Baseline in Level of Soluble Interleukin-6 Receptor|"Soluble Interleukin-6 receptor levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.~The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic Population: All patients who received at least one tocilizumab infusion and had at least one pharmacokinetic and pharmacodynamic sample. Only those patients with available data at each time point are included in the analysis (indicated by N). Patients who did not receive their week 8 dose were excluded.||ng/mL||Standard Deviation|Mean
59926|NCT01209780|Secondary|Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.~This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40."|Day 22 for non-naive/Day 50 for naive|Analysis was performed on the per protocol population.||Percentages of subjects||95% Confidence Interval|Number
59927|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)|The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on the per protocol population.||Titers||95% Confidence Interval|Geometric Mean
59928|NCT01209780|Secondary|Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.|"The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.~This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%."|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on per protocol population.||Percentages of subjects||95% Confidence Interval|Number
59929|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion|"The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.~Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer"|Day 22 for non-naive/Day 50 for naive subjects|Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.||Percentages||95% Confidence Interval|Number
59930|NCT01209767|Primary|Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.|"Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom Cryolipolysis or Subcision resulted in the best cosmetic appearance. It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better."|12 weeks|||Percentage of participants||90% Confidence Interval|Number
59931|NCT01209702|Secondary|Part 1: The Number of Participants With Adverse Events|A serious adverse event (AE) is any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one or other of the outcomes listed above. The intensity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.02. A severe AE was any event of Grade 4 (life-threatening consequences; urgent intervention indicated) or 5 (death related to AE).|Up to 40 weeks|The safety analysis population included all patients who received at least one tocilizumab/placebo infusion and had at least one postdose safety assessment. Patients were assigned to treatment groups as treated for analysis.||participants|||Number
59932|NCT01209702|Secondary|Part 2: Percentage of Participants With a Reduction of Magnetic Resonance Imaging (MRI) Proven Spinal Inflammation|Magentic resonance imaging of the axial skeleton was to be performed at Baseline and Week 24. MRI scans will be evaluated using the ankylosing spondylitis spinal MRI activity (ASspiMRI-a) score, grading activity (0-6) per vertebral unit in 23 units.|Baseline and Week 24|Due to premature study termination this outcome measure was not analyzed.|||||
59933|NCT01209702|Secondary|Part 2: Radiographic Change According to the Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)|"Radiographs were to be assessed using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where:~0 = No abnormality;~1 = Erosion, sclerosis, or squaring;~2 = Syndesmophyte;~3 = Total bony bridging at each site."|Baseline and Week 104|This outcome measure was not analyzed due to premature study termination.|||||
59934|NCT01209702|Primary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.||percentage of participants|||Number
59935|NCT01209702|Secondary|Number of Participants With Anti-tocilizumab Antibodies|A positive anti-tocilizumab antibody result was defined as a negative assay result at Baseline and a positive post-baseline screening assay with positive confirmation or neutralizing assay at the same visit.|From Baseline until end of study (a maximum treatment duration of 40 weeks).|All patients treated with tocilizumab and screened for anti-tocilizumab antibodies at any timepoint.||participants|||Number
59937|NCT01209702|Secondary|Change From Baseline in the Level of Interleukin-6|"Interleukin-6 levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.~The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic (PK) Population: All patients who received at least one tocilizumab infusion and had at least one PK and pharmacodynamic sample. Only patients with available data at each time point are included (indicated by N). Patients who did not receive their Week 8 dose were excluded.||pg/mL||Standard Deviation|Mean
59938|NCT01209702|Secondary|Part 2: Volume of Distribution of Tocilizumab|Volume of distribution of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
59939|NCT01209702|Secondary|Part 2: Clearance of Tocilizumab|Clearance of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
59940|NCT01209702|Secondary|Part 2: Elimination Half-life of Tocilizumab|Elimination half-life of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
59941|NCT01209702|Secondary|Part 2: Peak Plasma Concentration of Tocilizumab|The peak plasma concentration (Cmax) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
59942|NCT01209702|Secondary|Part 2: Area Under the Plasma Concentration Versus Time Curve of Tocilizumab|Area under the plasma concentration versus time curve (AUC) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.|||||
59943|NCT01209702|Secondary|Change From Baseline in C-Reactive Protein|Levels of C-reactive protein (CRP) were measured from blood samples taken at Baseline and at Week 12.|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.||mg/dL||Standard Deviation|Mean
59944|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|"The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are:~Tragus-to-wall;~Modified Schober (lumbar flexion);~Cervical rotation;~Lateral spinal flexion;~Intermalleolar distance.~The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient’s limitation of movement due to their AS."|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.||scores on a scale||Standard Deviation|Mean
59945|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|The Bath Ankylosing Spondylitis Functional Index (BASFI) is an assessment of function in AS patients. The participant provides their assessment of their ability to perform 10 activities on a 100 mm horizontal visual analog scale (VAS) ranging from 0 (easy) to 100 (impossible). The BASFI score is the mean of these values and is tabulated on a 0 (best) to 10 (worst) cm scale.|Baseline and Week 12|Intent-to-treat population for whom data were available. The analysis was not performed for participants in Part 2.||cm||Standard Deviation|Mean
59946|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|"The BASDAI is a patient-administered assessment of 6 parameters specific to AS. The following parameters were assessed on a 100-mm horizontal visual analogue: fatigue, spinal pain, peripheral arthritis, enthesitis, intensity of morning stiffness, and duration of morning stiffness. For questions 1 to 5, the left-hand extreme of the line (0) represents none (symptom-free) and the right-hand extreme (100) represents very severe (maximum severity). For question 6, a time axis was used, with the left-hand extreme of the line representing 0 hours and the right-hand extreme representing 2 or more hours. The BASDAI score was calculated as follows:~BASDAI = [Q1 + Q2 + Q3 + Q4 + (Q5 + Q6)/2]/5. The total score is tabulated on a scale from 0 (best) to 10 cm (worst)."|Baseline and Week 12|Intent-to-treat population where data were available.||cm||Standard Deviation|Mean
59947|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 24|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT), Part 2 study population. This analysis was not performed due to premature study termination.|||||
59953|NCT01209624|Primary|Percentage of Participants With Progression of Visual Field|Progression defined as visual field deterioration rated progressive by physician on at least 1 post-baseline visit, and increase in Aulhorn stage (by at least 1 stage) and/or decrease in mean defect by at least 2.5 dB (Last Visit minus Baseline).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have had Visual Field Deterioration rated as progressive by the physician on at least 1 post-baseline visit, and at least one measure of increase in Aulhorn Stage by at least 1 stage, and decrease in Mean Defect by at least 2 dB (last visit minus baseline).||Percentage of Participants|||Number
73800|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Creatinine|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
59948|NCT01209702|Secondary|Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 12|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.||percentage of participants|||Number
59949|NCT01209702|Secondary|Percentage of Participants Who Achieved a Value <2 in Each of the 4 ASAS Parameters at Week 12|"Assessment in Ankylosing Spondylitis (ASAS) is composed of four domains.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI), the mean of 10 self-assessment questions on a 100 mm VAS.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).~Each of the above 4 domains are measured on a scale from 0-100 mm, but reported on a 0-10 cm scale. A score of less than 2 units (20 mm) in each domain is defined as partial remission."|Week 12|Intent-to-treat. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.||percentage of participants|||Number
59950|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.||percentage of participants|||Number
59951|NCT01209702|Primary|Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient’s overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|"Intent-to-treat (ITT) population included all patients who were randomized into the study and received at least one tocilizumab/placebo infusion.~If the response at the 12-week visit could not be determined due to early withdrawal or missing data then the patient was considered a non-responder."||percentage of participants|||Number
59952|NCT01209689|Primary|Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12|ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index [BASFI] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index [BASDAI] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.|Baseline to Week 12|Intent-to-treat population: All randomized patients who received at least 1 dose of treatment. The analysis only included assessments while patients were receiving double-blind treatment and that occurred prior to withdrawal or the date when all patients were unblinded (15 Jul 2011). Patients who withdrew or escaped were considered non-responders.||Percentage of patients|||Number
59977|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 12|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.||Participants|||Number
59954|NCT01209624|Primary|Percentage of Participants With Progression of Optic Disc Excavation|Progression (Last Visit minus Baseline) defined as increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2, and/or decrease in at least 1 of Heidelberg Retina Tomograph (HRT) parameters (deterioration of rim area 0.2 mm2; deterioration of rim volume 0.1 mm3 deterioration or mean retinal nerve fiber layer (RNFL) thickness 0.1 mm).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of following events: increase in horizontal or vertical cup to disc ratio, or decrease in rim area, rim volume, or mean RNFL thickness. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Percentage of Participants|||Number
59955|NCT01209624|Primary|Percentage of Participants With Overall Progression of Glaucoma Damage|Overall progression defined as at least 1 of the 6 individual progression of glaucoma damage measures met: increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2; at least 1 post Baseline (BL) optic-disc hemorrhage; decreased rim area (0.2 mm2), rim volume (0.1 mm3), mean retinal nerve fiber layer (RNFL)(0.1 mm), progressive visual field deterioration, increase in Aulhorn stage (by at least 1 stage), and/or decrease in mean defect by at least 2.5 decibels [dB])|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of the six individual progression of glaucoma damage measures. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Percentage of Participants|||Number
59956|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect|Decrease in mean defect by at least 2.5 decibels (dB) (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value for mean defect at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
59957|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage|Increase in Aulhorn Stage by at least one stage (last visit minus baseline). Three different visual field defect categories defined using Aulhorn stage values 1-5: Aulhorn stage 1 = mild damage, Aulhorn stages 2, 3 = moderate damage, Aulhorn stages 4, 5 =severe damage.|Month 24 (or last visit)|PP; results based on participants with a value for Aulhorn Stage at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
59958|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration|Visual Field Deterioration rated as progressive by physician on at least one post-baseline visit; range: 1= improved 2= stable 3= progressive. If both eyes were treated with Xalatan® the value for the right eye was used; otherwise, only the assessment for the eye treated with study medication was used.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of change in visual field defect. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
59959|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness|Decrease in at least one Heidelberg Retina Tomograph (HRT) parameter by: Rim Area 0.2 millimeter (mm)2, Rim Volume 0.1 mm3, or mean retinal nerve fiber layer (RNFL) Thickness 0.1 mm, (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value of the variable in question at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
59960|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage|Participants with at least one post-baseline optic disc hemorrhage.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of optic disc hemorrhage. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Particpants|||Number
59961|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio|Increase in Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio by at least 0.2 (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with both a Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.||Participants|||Number
59962|NCT01209624|Primary|Number of Participants With Investigator Assessments of Efficacy at Month 24|Number of participants with Investigator assessments of the efficacy of Xalatan® treatment rated as: 1=very good, 2=good, 3=moderate, 4=insufficient. If study medication was stopped before 24 months, assessment was performed at the time of early termination.|Month 24|PP; N = number of participants with a non-missing response at Month 24 visit.||Participants|||Number
59963|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Visual Field Defect|Change in mean defect right and left eye; valid range: -30 - + 30 decibels (dB). Visual field defect categories: preperimetric glaucoma: ≥ -2 dB; mild damage: < -2 dB and ≥ -3.3 dB; moderate damage: < -3.3 dB and ≥ -4.6 dB; and severe damage: < -4.6 dB. If both eyes were treated with Xalatan® , the value for the right eye was used; otherwise, only the mean defect value for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided a Mean Defect value at both Baseline and Month 24 visits.||Participants|||Number
59964|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages|Values of change in Aulhorn Stage measured by Humphrey Visual Field Analyzer. Aulhorn stages: no scotoma, Stage I (relative scotomas only), Stage II (absolute scotomas without connection to blind spot), Stage III (absolute scotomas with connection to blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If both eyes were treated with Xalantan® the value of right eye was analyzed; otherwise, only the assessment for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided Aulhorn stage values of 1 to 5 at both baseline and month 24 visits.||Participants|||Number
59978|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 24|PP; N = number of participants with analyzable data at observation.||Participants|||Number
94432|NCT00860470|Primary|Infant Mortality Through 6 mo of Age|Risk of Infant Mortality to Age 6 months (180 days)|Dec 2014|||participants|||Number
59965|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness|Mean retinal nerve fiber layer (RNFL) thickness in millimeters (mm) right and left eye assessed by HRT imaging. Valid range: 0.100 to 0.400 mm. Only the RNFL for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for RNFL thickness.||mm||Standard Deviation|Mean
59966|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure|Cup shape measure right and left eye assessed by HRT imaging . Valid range: -0.400 to -0.010. Only the cup shape measure for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for cup shape measure.||Cup shape measure||Standard Deviation|Mean
59967|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume|Rim volume (mm3) right and left eye assessed by HRT imaging. Valid range: 0.080 to 0.700 mm3. Only the rim volume for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim volume.||mm3||Standard Deviation|Mean
59968|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area|Rim area (millimeter [mm]2) right and left eye assessed by HRT imaging. Valid range: 0.500 to 1.900 mm2. Only the rim area for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim area.||mm2||Standard Deviation|Mean
59969|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 24|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 24|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
59970|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 18|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 18|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
59971|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 12|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 12|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
59972|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 6|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 6|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.||Participants|||Number
59973|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP. N = number of participants with vertical cup to disc ratio at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in vertical cup to disc ratio in participants with a non-missing response at both baseline and at least one post-baseline visit.||Ratio||Standard Deviation|Mean
59974|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; N = number of participants with horizontal cup to disc ratio data at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in participants with a non-missing response at both baseline and at least one post-baseline visit.||Ratio||Standard Deviation|Mean
59975|NCT01209624|Primary|Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit|Percentage of participants who achieved their IOP target set at baseline. Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.|Month 24, (or last visit)|PP; n = number of subjects in the Per Protocol Analysis Set with a non-missing response at Last Visit. Last visit = last post-baseline visit at which participant provides a value of IOP.||Percentage of Participants|||Number
59976|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 24|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.||Participants|||Number
59979|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 12|PP; N = number of participants with analyzable data at observation.||Participants|||Number
94433|NCT00860457|Secondary|Number of Patients With Adverse Events|Adverse events were evaluated as per the NCI Criteria for Adverse Events, version 3.0.|3 years||||||
59980|NCT01209624|Primary|Change From Baseline in Raw Intraocular Pressure (IOP) by Visit|Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|Per protocol (PP) analysis set: all participants in the Full Analysis Set (at least 1 dose of Xalatan® and 1 post-baseline IOP measurement) who were treated for ≥18 months; had at least BL and 1 post-BL non-missing efficacy assessments for IOP at least 18 months apart; without ametropy at BL; and without additional glaucoma medication during study.||mmHg||Standard Deviation|Mean
59981|NCT01209520|Primary|Degree of Demethylation in Patient Tumor Tissue and/or Serum Induced by 5-azacitidine on Specific Tumor Specific Genes (TSGs)|To measure the grade of demethylation induced by 5-azaciditine on specific TSGs by analyzing plasma DNA, and global demethylation by analyzing WBC DNA, and determine the duration of this effect.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.|||||
59982|NCT01209520|Primary|Percentage of Patients Showing a Presence of Methylated Tumor Suppressor Genes in Their Tumor Tissue and/or Serum Achieving Partial or Complete Response to Protocol Therapy.|To determine the feasibility and efficacy of incorporating a demethylating agent (5-azacitidine; Vidaza®, Celgene, Summit, NJ, USA) as part of adjuvant therapy in patients diagnosed with NSCLC who harbor methylated tumor supressor genes (TSGs) in their tumor tissue and/or serum. Response to be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.0.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.|||||
59983|NCT01209286|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) is 125 pg/mL and the limit of detection (LOD) is 20 pg/mL.|Samples were collected prior to treatment start (baseline), and at 2, 6, 24, and 48 hours after drug infusion start, and at these same time points when dose is escalated in each treatment cycle.|Participants who received blinatumomab and who had evaluable pharmacodynamic data.||pg/mL||Standard Deviation|Mean
59984|NCT01209286|Secondary|Clearance of Blinatumomab|Clearance was calculated as R0/Css; where R0 is the infusion rate (μg/m^2/hr) and Css is the steady state concentration.|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.||L/m^2/hr||Standard Deviation|Mean
59985|NCT01209286|Secondary|Steady State Blinatumomab Concentration|"The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the intravenous infusion was started for cycle 1 and cycle 2, respectively. Actual doses administered were used in the analysis.~Concentrations below the limit of detection (3 pg/mL) were set to zero before data analysis and concentrations below the lower limit of quantitation (50 pg/mL) were excluded from analysis."|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.||pg/mL||Standard Deviation|Mean
59986|NCT01209286|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 and according to the following:~Grade I (mild); Grade 2 (moderate); Grade 3 (severe - significantly limits the patient's ability to perform routine activities despite symptomatic therapy; Grade 4 (life-threatening); Grade 5 (death).~The investigator used medical judgment to determine if there was a causal relationship (ie, certain, probable, possible, unlikely, not related) between an adverse event and blinatumomab.~A serious adverse event is any untoward medical occurrence or effect, that at any dose:~resulted in death, was life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically important condition."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle; median treatment duration was 55.7 days.|Safety analysis set, defined as all participants who received any infusion of blinatumomab.||participants|||Number
59987|NCT01209286|Secondary|Overall Survival|Overall survival was measured for all participants from the date of first infusion of blinatumomab until the date of death due to any cause. Participants who did not die were censored on the last documented visit date. Overall survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 667 days.|Full analysis set||days||95% Confidence Interval|Median
59988|NCT01209286|Secondary|Relapse-free Survival|Relapse-free survival was measured only for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Relapse-free survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.||days||95% Confidence Interval|Median
59989|NCT01209286|Secondary|Time to Hematological Relapse|"Time to hematological relapse was measured for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their day of death.~Hematological Relapse was defined as:~Proportion of blasts in bone marrow > 5%~Extramedullary relapse.~Time to hematological relapse was analyzed by Kaplan-Meier methods."|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.||days||95% Confidence Interval|Median
59990|NCT01209286|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab|The percentage of participants who underwent immediate allogeneic HSCT (defined as those in remission who undergo HSCT without receiving any other treatments) after having discontinued or completed the core study.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days|Full analysis set||percentage of participants|||Number
59991|NCT01209286|Secondary|Percentage of Participants With a Minimal Residual Disease (MRD) Response During the Core Study|A minimal residual disease (MRD) response is defined as MRD < 10^-4 blasts/nucleated cells based on polymerase chain reaction (PCR) evaluation of individual rearrangements of immunoglobulin or T cell receptor genes.|During the core study treatment period (up to 30 weeks).|Full analysis set (FAS)||percentage of participants||95% Confidence Interval|Number
59992|NCT01209286|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Partial remission was defined by the following criteria:~• Bone marrow blasts ≤ 25%"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
59993|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete remission with only partial hematological recovery (CRh*) was defined by the following criteria:~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Partial recovery of peripheral blood counts:~Platelets > 50,000/μL~Hemoglobin ≥ 7 g/dL~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
59994|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete Response/Remission (CR) was defined by the following criteria:~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Full recovery of peripheral blood counts:~Platelets > 100,000/μL~Hemoglobin ≥ 11 g/dL~Absolute neutrophil count (ANC) > 1,500/μL"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
59995|NCT01209286|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Hematological remissions were defined by the following criteria:~Complete Response/Remission (CR):~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Full recovery of peripheral blood counts:~Platelets > 100,000/μL~Hemoglobin ≥ 11 g/dL~Absolute neutrophil count (ANC) > 1,500/μL~Complete Remission with only Partial Hematological Recovery (CRh*):~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Partial recovery of peripheral blood counts:~Platelets > 50,000/μL~Hemoglobin ≥ 7 g/dL~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set (FAS), defined as participants who received any infusion of the assigned study medication, who completed at least the first treatment cycle and for whom at least one response assessment was available after the start of treatment.||percentage of participants||95% Confidence Interval|Number
59996|NCT01209260|Secondary|Plastic Dilator Shavings|In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.|immediately prior to procedure|The assigned needle for each participant was analyzed prior to the procedure||Needles|Participants||Number
59997|NCT01209260|Secondary|Performance of the Assigned Needle Type|Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.|at time of procedure|||participants|||Number
59998|NCT01209260|Secondary|Number of Participants With Adverse Events as a Measure of Safety||During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.|||participants|||Number
59999|NCT01209260|Primary|Transseptal Access Procedure Time|Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.|Day of procedure|||minutes||Inter-Quartile Range|Median
60000|NCT01209195|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 163 weeks, and a collection was made post-infusion in any case of infusion reaction||||||Number
60001|NCT01209195|Secondary|Pharmacokinetic Parameters (AUClast)|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).~Immunogenicity data is not available."|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
60002|NCT01209195|Secondary|To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."||ug/mL||Geometric Coefficient of Variation|Geometric Mean
60003|NCT01209195|Secondary|To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 163 weeks|||participants with objective response|||Number
60004|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.~Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|note: MTD of MM-121 when administered in combination with paclitaxel provided in separate endpoint entry||mg/m2|||Number
60005|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.~Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|NOTE: MTD of paclitaxel when administered with MM-121 provided in separate endpoint entry||mg/kg|||Number
60006|NCT01209195|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)|To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 163 weeks|||participants reporting DLTs|||Number
60007|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of Cmax of ethinyl estradiol and norethindrone were defined as the ratios of Cmax of ethinyl estradiol and norethindrone on Day 8 divided by Cmax of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL||90% Confidence Interval|Number
60008|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of AUC(0-inf) of ethinyl estradiol and norethindrone were defined as the ratios of AUC(0-inf) of ethinyl estradiol and norethindrone on Day 8 divided by AUC(0-inf) of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL*hr||90% Confidence Interval|Number
60046|NCT01208337|Secondary|Incidence of Biopsy-proven Acute Cellular Rejection|Biopsy-proven incidence of acute cellular rejection|1 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).||participants|||Number
60009|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of Cmax of rosiglitazone was defined as the Cmax of rosiglitazone on Day 8/ Cmax of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL||90% Confidence Interval|Number
60010|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of AUC(0-inf) of rosiglitazone was defined as the AUC(0-inf) of rosiglitazone on Day 8/AUC(0-inf) of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.||ng/mL*hr||90% Confidence Interval|Number
60011|NCT01208961|Primary|C(Max): Maximum Plasma Concentration|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.|||nmol/mL||Full Range|Geometric Mean
60012|NCT01208961|Primary|AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.|||nmol.h/mL||Full Range|Geometric Mean
60013|NCT01208961|Primary|AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.|||nmol.h/mL||Full Range|Geometric Mean
60014|NCT01207596|Secondary|Global Assessment of Treatment Satisfaction|Patients were asked to rate their global assessment of treatment satisfaction, ranging from “very dissatisfied” to “very satisfied”. Adverse events were monitored throughout the study|Baseline visit to Week 12 or last visit|LOCF||percentage of patients|||Number
60015|NCT01207596|Secondary|Pain Quality Assessment Scale (PQAS)|The PQAS is a 20-item scale that quantifies the quality and intensity of neuropathic and non-neuropathic pain; scores range from 1 to 200, with higher scores indicating more severe pain|Baseline visit to 12 weeks visit|LOCF||units on a scale||Standard Error|Mean
60016|NCT01207596|Secondary|Sleep Quality Assessment (SQA)|Sleep Quality Assessment (SQA) scale, asking patients to assess the degree that pain has interfered with their sleep in the last 24 hours (where 0 = does not interfere and 10 = completely interferes)|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Deviation|Mean
60017|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now|"Change from baseline to end of study on question #4 (current pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that tells how much pain you have right now, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Error|Mean
60018|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours|"Change from baseline to end of study on question #4 (least pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Deviation|Mean
60019|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours|"Change from baseline to end of study on question #3 (worst pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Deviation|Mean
60020|NCT01207596|Primary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale|The primary efficacy measure was the change from baseline to end of study on question #5 (“average pain”) of the Brief Pain Inventory (BPI): “Please rate your pain by marking the box beside the number that best describes your pain on the average,” where 0 = no pain and 10 = pain as bad as you can imagine.|Baseline visit to Week 12 or last visit|LOCF||units on a scale||Standard Error|Mean
60289|NCT01205269|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||mmHg||Standard Deviation|Mean
60021|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 4|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.||Percentage of participants|||Number
60022|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 3|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.||Percentage of participants|||Number
60023|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 2|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.||Percentage of participants|||Number
60024|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 1|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.||Percentage of participants|||Number
60025|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 4|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.||Percentage of participants|||Number
60026|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 3|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.||Percentage of participants|||Number
60027|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.||Percentage of participants|||Number
60028|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.||Percentage of participants|||Number
60029|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 4|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.||Percentage of participants||95% Confidence Interval|Number
60030|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 3|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.||Percentage of participants||95% Confidence Interval|Number
60031|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 2|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.||Percentage of participants||95% Confidence Interval|Number
68941|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8|Change in 24-hour urinary calcium excretion from Baseline to week 8|Baseline and week 8|||mmol/24hr||Standard Deviation|Mean
60032|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 1|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.||Percentage of participants||95% Confidence Interval|Number
60033|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion on day 4 after the crossover treatment|Day 4 after treatment|||degree||Standard Deviation|Mean
60034|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle dorsiflexion passive range of motion|Day 1 after treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.||degree||Standard Deviation|Mean
60035|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion at day 4 before the crossover treatment|day 4 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.||degree||Standard Deviation|Mean
60036|NCT01207570|Primary|Ankle Passive Range of Motion|The ankle passive range of motion will be measured by a Myrin goniometer.|day 1 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.||degree||Standard Deviation|Mean
60037|NCT01208402|Secondary|Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg|Duration of postoperative hours 4 to 12 patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 9 hours. SBP was measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting BB group and in 16 cases in the Esmolol group.||percentage of 8 hour interval||Inter-Quartile Range|Median
60038|NCT01208402|Primary|Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm.|Duration of postoperative hours 4 to 12 spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 9 hours. Vital signs are measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting beta blocker group and in 16 cases in the Esmolol group.||percentage of 8 hour interval||Inter-Quartile Range|Median
60039|NCT01208402|Secondary|Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg|Duration of postoperative first three hours patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 3 hours. SBP is measured from end of surgery to 3 hours postoperatively at 5 minute intervals for first hour and every 15 minutes thereafter.|end of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.||percentage of 3 hour interval||Inter-Quartile Range|Median
60040|NCT01208402|Primary|Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm|Duration of postoperative first three hours spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 3 hours. Vital signs are measured from end of surgery to 3 hours postoperatively at 5 minute intervals for the first hour and every 15 minutes thereafter.|End of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.||percentage of 3 hour interval||Inter-Quartile Range|Median
60041|NCT01208402|Secondary|Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg|Duration of intraoperative case time patient was not in the target window of SBP > 95 mmHg, expressed as percent of total case minutes. SBP is measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.||percentage of surgery minutes||Inter-Quartile Range|Median
60042|NCT01208402|Primary|Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm|Duration of intraoperative excursion (ie, time spent) outside Target HR range defined as 60 to 80 bpm during surgery, expressed as percent of case minutes. Vital signs are measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.||percentage of case minutes||Inter-Quartile Range|Median
60043|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|5 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.||participants|||Number
60044|NCT01208337|Secondary|Incidence of Patients in Whom Tacrolimus Whole Blood Concentration Less Than 10 ng/ml Are Being Used at 1-year Follow-up.|Tacrolimus whole blood concentrations less than 10 ng/ml|1 year|It is believed that patients whom received Alemtuzumab at the time of transplant and continue post-transplant with functioning grafts will have Tacrolimus whole blood concentrations less than 10ng/ml.||participants|||Number
60045|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|1 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.||participants|||Number
60047|NCT01208337|Primary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)|Asses safety of Alemtuzumab in combination with Tacrolimus and steroids in twenty-three pediatric intestine allograft recipients by calculating the rate in which PTLD occurred amongst the study population.|5 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).||participants|||Number
60048|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.||blocks moved per minute||Standard Error|Least Squares Mean
60049|NCT01208233|Other Pre-specified|Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
60050|NCT01208233|Other Pre-specified|Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2)||Day 1 (Baseline) up to Day 14|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
60051|NCT01208233|Other Pre-specified|Number of Participants With Neuro-worsening (Part 2)|NIHSS change of 4 points or greater.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
60052|NCT01208233|Other Pre-specified|Mortality Directly Related to Stroke (Part 2)|Deaths caused by stroke were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
60053|NCT01208233|Other Pre-specified|All-cause Mortality (Part 2)|Deaths regardless causality were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).||Number of participants|||Number
60054|NCT01208233|Secondary|Plasma Concentrations of PF-03049423 (Part 1 and 2)||Days 1, 2, 7, 14, 30, 60 and 90|PK concentration population included all participants who were treated with PF-03049423 who had at least 1 measurable concentration. n=participants with concentration above lower limit of quantification at the corresponding sampling time.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
60055|NCT01208233|Secondary|Gait Velocity Test at Day 90 (Part 2)|The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk “at a comfortable pace” at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant’s limb crossed the first marker and stopping the stopwatch as soon as the participant’s limb crossed the second marker.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||meters/second (m/s)||Standard Error|Least Squares Mean
60056|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)|This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||pictures correctly identified||Standard Error|Least Squares Mean
60065|NCT01208233|Secondary|Percentage of Participants With mRS (0-1) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).||percentage of participants|||Number
60290|NCT01205269|Secondary|Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose|Maximum FVC value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
60057|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated participants included for comparison between active drug and placebo for this outcome measure.||change in ratio||Standard Error|Least Squares Mean
60058|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test [(L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%)] at Day 90 (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo for this outcome measure.||change in percentage of lines crossed||Standard Error|Least Squares Mean
60059|NCT01208233|Secondary|Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)|This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||objects named correctly||Standard Error|Least Squares Mean
60060|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)|The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||correct responses||Standard Error|Least Squares Mean
60061|NCT01208233|Secondary|BI at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant’s ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||unit on a scale||Standard Error|Least Squares Mean
60062|NCT01208233|Secondary|Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant’s ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).||percentage of participants|||Number
60063|NCT01208233|Secondary|Change From Baseline in NIHSS at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.||unit on a scale||Standard Error|Least Squares Mean
60064|NCT01208233|Secondary|Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).||percentage of participants|||Number
99710|NCT00817219|Primary|Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment||Baseline and 4 weeks|||mmol/L||Standard Deviation|Mean
60066|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated those participants included for comparison between active drug and placebo.||percentage change||Standard Error|Least Squares Mean
60067|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.||pounds||Standard Error|Least Squares Mean
60068|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.||percentage change||Standard Error|Least Squares Mean
60069|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.||blocks moved per minute||Standard Error|Least Squares Mean
60070|NCT01208233|Primary|Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The Inferential Full Analysis Set (I-FAS) consisted of participants within the FAS who were randomized to PF-03049423 maximum tolerated dose (MTD) or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.||percentage of participants|||Number
60071|NCT01208233|Primary|Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)|"Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for any of above mentioned categories was assessed. *This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together."|Day 7 (Baseline) up to follow up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of participants who had C-SSRS assessed at that visit.||participants|||Number
60111|NCT01207453|Secondary|Symptom Intensity Scale (SIS)|A measure of the change in SIS score from baseline to 6 weeks. The SIS score ranges from 0-9.75, with high scores being worse indicating more widespread pain and fatigue.|Baseline to 6 weeks|||units on a scale||Standard Deviation|Mean
60292|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
60072|NCT01208233|Primary|Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)|The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had neurological examinations done at both baseline and last visit.||participants|||Number
60073|NCT01208233|Primary|Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)|The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had physical examinations done at both baseline and last visit.||participants|||Number
60074|NCT01208233|Primary|Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QT interval: >=500 msec, QTc interval using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; absolute change 30 - <60, >=60 msec. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.||participants|||Number
60075|NCT01208233|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from grand baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine, sitting and standing): <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.||participants|||Number
60076|NCT01208233|Primary|Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated number of participants evaluated.||participants|||Number
60077|NCT01208220|Primary|Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)||2 weeks into study|||Percentage of red granulation tissue|||Number
60078|NCT01208220|Secondary|Removal of Harmful Fluids in the Wound Tissue||2 weeks into study|||percentage of cytotoxins removed|||Number
60079|NCT01208207|Primary|Number of Participants Discontinuing Study Treatment Due to an Adverse Event||Up to 26 weeks|All Patients as Treated Population (APaT) - Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.||Participants|||Number
60080|NCT01208207|Secondary|Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.|Week 6 to Week 10 and Week 12|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.||mm VAS||95% Confidence Interval|Least Squares Mean
60081|NCT01208207|Secondary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.||mm VAS||95% Confidence Interval|Least Squares Mean
60191|NCT01205828|Primary|Clinical Benefit Rate|complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria|8 weeks|||participants|||Number
63853|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|baseline - before 1st block|Blood sample was not collected for 5 Entonox patients and 1 Oxygen patients.||pg/ml||Inter-Quartile Range|Median
60082|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.||mm VAS||95% Confidence Interval|Least Squares Mean
60083|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.||mm VAS||95% Confidence Interval|Least Squares Mean
60084|NCT01208181|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 12|ASaT population defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of participants|||Number
60085|NCT01208181|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 112 days|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.||Percentage of participants|||Number
60086|NCT01208181|Secondary|Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with <50% improvement from baseline in PGAP [VAS] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed."|Week 6 and Week 10 to Week 12|This population (a subpopulation of the mITT population) was composed of pain inadequate responder (PIRs) in Part 1. PIRs were defined as participants with <50% improvement from baseline in Patient Global Assessment of Pain (VAS) at Week 6 and received at least one dose of study medication in Part 2.||Scores on a scale||95% Confidence Interval|Least Squares Mean
60087|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
60088|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
60089|NCT01208181|Primary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
63854|NCT01172600|Secondary|Usage of Opioid||3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow up.||participants|||Number
60090|NCT01208181|Primary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.|Baseline and Week 6|The modified intention-to-treat (mITT) population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.||Scores on a scale||95% Confidence Interval|Least Squares Mean
60091|NCT01207934|Secondary|Post-treatment Plasma Leptin Levels|plasma leptin levels after fourteen days ingestion of either leptin or placebo.|fourteen days|||Micrograms/Liter||Standard Error|Mean
60092|NCT01207934|Primary|Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.|This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|fourteen days|||mmol/kg body weight/minute||Standard Error|Mean
60093|NCT01207934|Secondary|Baseline Plasma Leptin Concentrations|Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.|baseline|||Micrograms/Liter||Standard Error|Mean
60094|NCT01207934|Primary|Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.|pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|baseline|||mmol/kg body weight/minute||Standard Error|Mean
60095|NCT01207765|Secondary|Degree of CD20 Expression on Plasma Cells and/or Targeting of Post-germinal Center B Cells Correlation With Toxicity, Response and Biodistribution|CD20 immunohistochemical staining of plasma cells on baseline bone marrow biopsy specimen, graded on qualitative scale (0 to +++)|2 weeks prior - 2 weeks post transplant|Immunohistochemical analysis showed inconsistent / insufficient CD20 staining on surface of plasma cells; comparisons could not be made|||||
60096|NCT01207765|Secondary|Time to Engraftment in Patients Who Proceed to Myeloablative Chemotherapy After Receiving 90Y Zevalin® (Ibritumomab Tiuxetan).|Number of days from stem cell infusion (day +0) to day of neutrophil engraftment (first of three consecutive days with absolute neutrophil count > 500)|Transplant through day 42|Analyzed on intent-to-treat basis||Days||Full Range|Median
60097|NCT01207765|Primary|Safety and Efficacy|Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.|Through day +104 following immunotherapy|6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety||participants|||Number
60098|NCT01207648|Secondary|Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Months||95% Confidence Interval|Median
60099|NCT01207648|Secondary|Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness. Annualized relapse rate was defined as number of attacks per year.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Attacks per year|||Number
60100|NCT01207648|Primary|Number of Participants With Abnormal Laboratory Parameters|Laboratory parameters assessed for abnormality were: total white blood cell count (Neutrophils, Lymphocytes, Leukocytes, Monocytes, Eosinophils and Basophils), differential hematogram (Hematocrit, Erythrocytes, Hemoglobin, and Platelet), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and thyroid tests (including Triiodothyronine, Thyroxine, Thyroperoxidase Antibody and Thyroid-Stimulating Hormone). Due to the retrospective nature of the study, laboratory data should be interpreted with caution as data were not collected according to a specific time schedule and the time on study per participant was not standardized.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study. 'n' signifies number of participants who were evaluable for the specified categories.||Participants|||Number
60192|NCT01205685|Secondary|Correlative Studies|Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin|< or = to 2 weeks before initiation of Phase II study treatment period|No correlative studies were performed because the study did not move to the Phase II portion|||||
60101|NCT01207648|Primary|Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®)|Medical events in the retrospective study are equivalent to adverse events in a prospective clinical study. A medical event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious medical event: A medical event that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants may be represented in more than one category as participant who had experienced serious medical event may also had experienced non-serious medical event reported by the Investigator as related to Rebif®, so in that case it will be counted in both the categories.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.||Participants|||Number
60102|NCT01207648|Primary|Number of Participants With Pre-specified Medical Events|These pre-specified medical events categories were evaluated: injections site reactions, flu-like symptoms, hepatic disorders, blood cell disorders, allergic reactions, epilepsy and convulsive disorders, thyroid dysfunction, autoimmune diseases, bone/epiphyseal and cartilage disorders, serious infections, malignancies. Each category defined by group of events which best fit the medical concept either using a standard medical dictionary for regulatory activities (MedDRA) Query (SMQ) e.g., Malignancies was defined by the SMQ Malignancies (narrow scope) containing more than 1800 different preferred terms (PTs) (including procedures and lab tests) or using a customized query, e.g., Serious infections was defined by all PTs assessed as serious in System Organ Class (SOC) Infections and Infestation. Participants may be represented in more than once in a category (Participants could have reported several medicals events pertaining to a specific category) as well as in more than one category.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.||Participants|||Number
60103|NCT01207492|Secondary|Clinical Benefit Rate|To determine the clinical benefit rate [% CR + % PR + % stable disease by RECIST 1.1] at 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|6 months|||percentage of participants||95% Confidence Interval|Number
60104|NCT01207492|Secondary|Overall Tumor Response Rate (OR)|To determine overall tumor response rate [% complete response (CR) + % partial response (PR) by RECIST 1.1]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.|2 years|||percentage of participants||95% Confidence Interval|Number
60105|NCT01207492|Primary|Percentage of Participants With Progression Free Survival|To estimate progression free survival at 6 months in participants with recurrent PVNS treated with nilotinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months|||percentage of participants with PFS||95% Confidence Interval|Number
60106|NCT01207466|Primary|Quality of Vision (Crisp and Clear)|Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week’s wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale|Participants|Standard Deviation|Mean
60107|NCT01207453|Secondary|Knee Pain Threshold|A measure of the change in knee pain threshold from baseline to 6 weeks. Knee pain threshold was determined by applying pressure to a subject's knee until the subject felt pain. The difference between the average knee pain threshold (an average for the right and left knees) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
60108|NCT01207453|Secondary|Wrist Pain Threshold|A measure of the change in wrist pain threshold from baseline to 6 weeks. Wrist pain threshold was determined by applying pressure to a subject's wrist until the subject felt pain. The difference between the average wrist pain threshold (an average for the right and left wrists) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
60109|NCT01207453|Secondary|Trapezius Pain Threshold|A measure of the change in trapezius pain threshold from baseline to 6 weeks. Trapezius pain threshold was determined by applying pressure to a subject's trapezius muscle until the subject felt pain. The difference between the average trapezius pain threshold (an average for the right and left trapezii) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
60110|NCT01207453|Secondary|Thumbnail Pain Threshold|A measure of the change in thumbnail pain threshold from baseline to 6 weeks. Thumbnail pain threshold was determined by applying pressure to a subjectt's thumbnail until the subject felt pain. The difference between the average thumbnail pain threshold (an average for the right and left thumbs) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
60112|NCT01207453|Secondary|Change in Conditioned Pain Modulation (CPM)|CPM is defined as the difference between pain threshold A (measured after a conditioning stimulus activates pathways that inhibit pain) and pain threshold B (measured before the conditioning stimulus is applied). The conditioning stimulus was immersion of the hand in a cold water bath. Pressure pain threshold was assessed at the trapezius muscle initially. Subjects were then instructed to immerse their hand in a water bath for 30 seconds. At 20 seconds, pressure pain threshold at the trapezius was assessed again. We defined the magnitude of subjects’ CPM as the difference in pressure pain threshold between baseline and 20 seconds after cold water immersion. This difference was compared to that measured at 6 weeks. The scale for the difference in CPM ranged from 0-11 kg/cm^2, with 0 indicating no change in CPM between 6 weeks and baseline and 11 indicating the maximum possible change. A greater change in CPM between baseline and 6 weeks is indicative of improvements in CPM.|Baseline to 6 weeks|||kg/cm^2||Standard Deviation|Mean
60113|NCT01207453|Primary|Brief Pain Inventory (BPI) Change|"A measure of change in scores on the BPI short form, a 24-hr average pain item, from baseline to 6 weeks, The BPI short form scores ranges from 0-10, with 10 being the worst pain."|Baseline to 6 weeks|||units on a scale||Standard Deviation|Mean
60114|NCT01207427|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.||Number of SBMs/week||Standard Error|Mean
60115|NCT01207414|Secondary|Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12|I-CGI-S incorporated the overall, combined impression of illness severity based upon the E-CGI-S and ST-CGI-S. Medically qualified raters evaluated the patient's illness in the previous 7 days at Baseline and Week 12 on a scale of 1 to 7 (1=normal not at all ill, 2=borderline mental illness or impairment, 3=mildly ill or impaired, 4=moderately ill or impaired, 5=marked ill or impaired, 6= severely ill or impaired or 7=among the most extremely ill patients. A negative change from baseline indicates improvement.|Baseline, Week 12|||Score on a scale||Standard Deviation|Mean
60116|NCT01207414|Secondary|Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12|Medically qualified raters used the ST-CGI-S at Baseline and Week 12 to evaluate safety and tolerability in the previous 7 days on a scale of 1 to 7 (1=Normal-no symptoms, 2=borderline severity, 3=mild impairment, 4=moderate, 5=marked, 6=severe, 7=among the most severe.) A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.||Score on a scale||Standard Deviation|Mean
60117|NCT01207414|Secondary|Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12|Medically qualified raters use the E-CGI-S scale at Baseline and Week 12 to assess the effectiveness of treatment by examining changes in positive symptoms [hallucinations (false perceptions), delusions (false beliefs), paranoia (unfounded distrust), conceptual disorganization (loosening of associations), or hostility], negative symptoms [apathy (lack of interest), avolition (lack of motivation), alogia (poverty of speech), and anhedonia (absence of pleasure)] and cognitive symptoms [concentration difficulties, difficulties with executive function (integrative reasoning), and illogical thinking] in the previous 7 days on a scale of 1 to 7 (1=normal, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill or 7=among the most extremely ill). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.||Score on a scale||Standard Deviation|Mean
60118|NCT01207414|Secondary|Number of Participants With Adverse Events, Serious Adverse Events or Death|"Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen.~Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.~Additional information about adverse events can be found in the Adverse Event section."|12 Weeks|Participants from the Safety Analysis Set- all randomized participants who received study drug (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.||Participants|||Number
60119|NCT01207414|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12|The TSQM consisted of 14 questions about the patient's satisfaction with the drug in 4 domains: Effectiveness [3 questions scored as 1(extremely dissatisfied) to 7(extremely satisfied)], Side Effects [question 4 scored as 0(no) or 1(yes);question 5 scored as 1(extremely bothersome) to 5(not at all bothersome);questions 6 - 8 scored as 1(a great deal) to 5(not at all)], Convenience [questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy);question 11 scored as 1(extremely inconvenient) to 5 (extremely convenient)] and Global Satisfaction [question 12 scored as 1(not at all confident) to 7(extremely confident);question 13 scored as 1(not at all certain) to 5(extremely certain);question 14 scored as 1(extremely dissatisfied) to 5(extremely satisfied)]. The scores of each of the domains were added together and an algorithm used to create a score of 0 to 100. Higher scores for each domain indicate a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.||Score on a scale||Standard Deviation|Mean
60120|NCT01207414|Primary|Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12|The I-CGI-C at Week 12 was the overall impression of medically qualified raters using three separate Clinical Global Impression of Change scales: efficacy (E-CGI-C); safety and tolerability (ST-CGI-S); and overall severity (I-CGI-S) combined for a total score. The I-CGI-C scale ranged from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.|Week 12|Participants from the Full Analysis Set (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.||Score on a scale||Standard Deviation|Mean
60121|NCT01207401|Primary|Median Visual Analogue Score Measuring Pain|"We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points:~Speculum placement~Tenaculum placement~Paracervical block administration(if subject is in this arm)~IUD insertion~Five minutes post procedure"|1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure|||units on a scale||Full Range|Median
60122|NCT01207388|Secondary|Resource Utilization||5 years||01/2020||||
60123|NCT01207388|Secondary|Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales|The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of study are reported for each dimension.|Baseline and the end of each treatment cycle (Day 29 of each cycle) and 30 days after last treatment (end of core study)|Full analysis set||units on a scale||Standard Error|Mean
60124|NCT01207388|Secondary|Change From Baseline in EORTC-QLQ-C30 Scales|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact).~For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.~The maximum changes from baseline to cycles 1 through 4 and to the end of the core study are reported."|Baseline and the end of each treatment cycle (Day 29 of each cycle) and 30 days after last treatment (end of core study)|Full analysis set||units on a scale||Standard Error|Mean
60125|NCT01207388|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows:~Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~An AE was considered “serious” if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition."|From the first dose of blinatumomab until 30 days after last dose. Adverse events are reported up to the data cut-off date of 05 August 2015; the median treatment duration was 55 days.|All participants who received any infusion of blinatumomab.||participants|||Number
60126|NCT01207388|Secondary|Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders|MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.|Baseline and end of cycle 1 (6 weeks)|Full analysis set participants who were in hematological complete remission at treatment start, with no MRD Response in the first treatment cycle, excluding Philadelphia-positive participants.||participants|||Number
60127|NCT01207388|Secondary|Duration of Complete MRD Response|"The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively.~MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4. Hematological relapse is defined as the unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia."|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants, who had an MRD complete response at cycle 1||months||95% Confidence Interval|Median
60128|NCT01207388|Secondary|Time to Hematological Relapse|Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.||months||95% Confidence Interval|Median
60129|NCT01207388|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.|100 days after HSCT, as of the data cut-off date of 05 August 2015|Full analysis set participants who underwent HSCT prior to relapse (hematological or extramedullary) excluding Philadelphia-positive participants||percentage of participants||95% Confidence Interval|Number
60130|NCT01207388|Secondary|Overall Survival|Overall survival was measured from the first treatment with blinatumomab until death due to any cause. Participants who did not die were censored at their last contact date.|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set||months||95% Confidence Interval|Median
60291|NCT01205269|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose|Average FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
60131|NCT01207388|Secondary|Hematological Relapse-free Survival (RFS)|"Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively.~Hematological relapse was defined as unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first).~The 18-month Kaplan-Meier estimate of hematological RFS is reported."|18 months|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.||percentage of participants||95% Confidence Interval|Number
60132|NCT01207388|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle|"At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.~Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle."|During the first cycle (6 weeks)|Primary endpoint full analysis set (Prim EP FAS) included all participants with an Ig TCR PCR MRD assay with the minimum required sensitivity of 1 x 10^-4 at central lab established at Baseline.||percentage of participants||95% Confidence Interval|Number
60133|NCT01207219|Secondary|Severity of Symptoms|PANSS total score is computed by summing the scores of positive, negative and general symptom subscores. The range of PANSS total score is from 30 to 210, range of PANSS positive and negative subscores is from 7 to 49, range of PANSS general symptoms subscore is from 16 to 112, with higher values representing worse outcome. CDS total score is computed by summing the scores of nine items of the scale. The range of CDS total score is from 0 to 27, with higher values representing worse outcome.|Baseline and 12 weeks|One subject in the waitlist control group has not completed all measures both at the baseline and 12 weeks. Measure of clinical severity has been missing in the data set. So that there are 37 subjects' data of clinical severity has been included for analysis.||units on a scale||Standard Deviation|Mean
60134|NCT01207219|Primary|Attention and Concentration|measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter “C” and “E” as quickly as possible. The time to completion, number of error and omission items were recorded. A “quality of search” index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome).|baseline and 12 weeks|||Correct number per second||Standard Deviation|Mean
60135|NCT01207219|Primary|Working Memory|measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.|baseline and 12 weeks|||Scores on a scale||Standard Deviation|Mean
60136|NCT01207219|Primary|Verbal Retention|The total number of correctly recalled words after short-term (10 minutes) and long-term (30 minutes) delay in the random condition of Hong Kong List Learning test.|baseline and 12 weeks|||correctly recorded words||Standard Deviation|Mean
60137|NCT01207219|Primary|Verbal Acquisition|Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.|baseline and 12 weeks|||correctly encoded words||Standard Deviation|Mean
60138|NCT01207102|Secondary|"To Assess the Safety and Tolerability of a Combination Regimen of Weekly Abraxane® and Carboplatin to Treat Women With Triple Negative Stage IV Metastatic Breast Cancer"|The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals.|2 years|Due to insufficient accrual, data analysis was not performed.|||||
60139|NCT01207102|Primary|PFS|The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.|PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first|Due to insufficient accrual, data analysis was not performed.|||||
60140|NCT01206777|Secondary|Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice|Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice.|6 months, as a before and after infusion survey|Post infusion surveys were collected and de-identified by assignment of an individual nurse identification number||percentage of nurses satisfied|||Number
60141|NCT01206777|Secondary|Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule||Determined from difference in expected time by package insert administration and actual time on day of treatment|||minutes for rapid R infusion||95% Confidence Interval|Mean
60142|NCT01206777|Primary|Incidence of Grade III and IV Hypersensitivity Reactions||Every 15 minutes from start of infusion until completion, for up to 1 hour|||percentage of patients|||Number
60143|NCT01206738|Primary|Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire|GPs were randomly allocated to receive their invitation to take part by email or by post. Outcome measure was proportion of GPs responding by completing the first questionnaire|27/1/20111 - 15/5/2011|880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively.||participants|||Number
60144|NCT01206738|Primary|Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed|Eight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.|Immediately after completion of questionnaire|||scenarios||Standard Deviation|Mean
60145|NCT01206660|Secondary|Physician’s Global Assessment (PGA) of Psoriasis Score at Day 28.|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Day 28|ITT Population. Participants who returned for at least one post baseline visit and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||units on a scale||Standard Deviation|Mean
60146|NCT01206660|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each the three signs and symptoms (erythema, scaling and plaque elevation).|Day 28|||participants|||Number
60147|NCT01206660|Primary|Clinical Success ITT|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Analysis was conducted using Intent-to-Treat (ITT)||participants|||Number
60148|NCT01206608|Secondary|Number of Participants With Adverse Events|Adverse events were monitored through Day 8 and serious adverse events through Day 30.|Through 30 days postdose||||||
60149|NCT01206608|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores|Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.|Through 96 hours postdose|||Units on a scale*hours||Standard Deviation|Mean
60150|NCT01206595|Secondary|Number of Patients With Adverse Events|All adverse events were to be recorded from the time of dosing through Day 8. Serious adverse events (SAEs) were to be recorded through Day 30.|Through 30 days postdose||||||
60151|NCT01206595|Primary|Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical pain.|Through 96 hours postdose|||hours||Inter-Quartile Range|Median
60152|NCT01206582|Secondary|Leukocyte and Platelet Counts|Measured by complete blood count|baseline, Day 4, Day 7, Day 56|||number x 10^9 cells/L||Standard Error|Mean
60153|NCT01206582|Secondary|Erythrocyte Count|Measured by complete blood count|baseline, Day 4, Day 7, Day 56|||number x 10^12 erythrocytes/L||Standard Error|Mean
60154|NCT01206582|Secondary|Hemoglobin|Measured by complete blood count|baseline, Day 4, Day 7, Day 56|||g/dL||Standard Error|Mean
60155|NCT01206582|Secondary|Activated Partial Thromboplastin Time (APTT)||baseline, Day 4, Day 7, Day 56|||Seconds||Standard Error|Mean
60156|NCT01206582|Secondary|Prothrombin Time||baseline, Day 4, Day 7, Day 56|||International Normalized Ratio (INR)||Standard Error|Mean
60157|NCT01206582|Secondary|Serum Creatinine||baseline, Day 4, Day 7, Day 56|||mg/dL||Standard Error|Mean
60158|NCT01206582|Secondary|Autonomic Functions|Subjects completed a standardized autonomic symptom questionnaire, the Composite Autonomic Severity Score (CASS) which consists of 2 subscores: cardiovagal (CASS-vag; 0-3) and adrenergic (CASS-adr;0-3), where 0, 1, 2, 3 represent non, mild, moderate, and severe dysfunction, respectively.|baseline, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||units on a scale||Standard Error|Mean
60159|NCT01206582|Secondary|Gastrointestinal Symptoms|Subjects recorded their GI symptoms every day in the validated Gastroparesis Cardinal Symptom Index (GCSI) - Daily Diary. For each subject, the daily GCSI data were averaged per week. Components coded 0 (no symptoms) to 5 (very severe). GCSI total score is the average of 9 components from the nausea/vomiting, fullness/early satiety, and bloating subscores. These individual subscores are averages of 3,4, and 2 components, respectively. Subscores for upper and lower abdominal pain, heartburn/regurgitation and FDA nausea, vomiting, fullness, and pain (NVFP) composite are averages of 2, 2, 7, and 4 components, respectively.|baseline, 8 weeks|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||units on a scale||Standard Error|Mean
60160|NCT01206582|Primary|Gastric Emptying Half-time|The time for half of the ingested solids or liquids to leave the stomach. Gastric emptying was assessed with ^13C Spirulina Breath Test. After an overnight fast, subjects consumed the test meal containing ^13C Spirulina. Breath samples were collected in duplicate glass tube using a straw to blow into the bottom of the tube to displace contained air. The ^13CO_2 content of the breath was determined by AB Diagnostics. The provide of ^13CO_2 excretion is used to estimate the half-time of gastric emptying.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||minutes||Standard Error|Mean
60161|NCT01206582|Primary|Venous Monocyte HO1 Activity|HO1 activity in white blood cells was measured by an assay that measures bilirubin production as a marker of HO1 activity.|baseline, Day 3, Day 7, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||pmol bilirubin/mg/h||Standard Error|Mean
60162|NCT01206582|Primary|Venous Plasma Heme-oxygenase 1 (HO1) Protein Concentration|HO1 protein concentration levels in plasma were assessed with a HO1 (human) enzyme-linked immunosorbent assay (ELISA) kit.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).||ng/mL||Standard Error|Mean
60163|NCT01206517|Primary|Terminal Phase (Elimination) Half-life (t1/2) of Asenapine|Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||hr||Standard Deviation|Mean
60164|NCT01206517|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine|AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||hr*ng/mL||Standard Deviation|Mean
60165|NCT01206517|Primary|Time to Maximum Plasma Concentration (Tmax) of Asenapine|tmax is the time from dosing to maximum plasma drug concentration levels.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||hr||Full Range|Median
60166|NCT01206517|Primary|Maximum Plasma Concentration (Cmax) of Asenapine|Cmax is the peak plasma concentration following a dose of the study drug.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
60167|NCT01206478|Secondary|Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores|Non-communicating Children’s Pain Checklist - Revised (NCCPC-R) used to measure outcome. The NCCPC-R is a 30 item measure intended to assess pain in children who are unable to speak because of cognitive or physical impairments. There are 7 sub-scales including vocal, social, facial, activity, body/limbs, physiological, and eating/sleeping. Each question has a potential score of 0 to 3. Scores are totaled for each sub-scale. Sub-scale scores are then added together for the Total Score. Total Scores can range from 0 to 90. The higher the score, the higher level of pain indicated by the child. This measure was completed by parents at week 0, week 10, and week 24.|baseline, 24 weeks|||units on a scale||Standard Deviation|Mean
60168|NCT01206478|Primary|% Calories Taken Orally|Percent Kilocalories (kcal) Obtained Orally. This measure was obtained using the 24 hour food recall, a standardized five-pass method developed by the US Department of Agriculture for use in national dietary surveillance. This measure has been widely used in several large trials and data suggest it is the most valid and reliable method of dietary assessment for children (20). The data were collected at week 0, week 10, and week 24 using standardized probes by highly trained research staff, and parents were presented with paper food models and measuring devices prior to interviews to reference during the recall. Recalls were analyzed with the Nutritional Data System for Research, version 2005; University of Minnesota, Minneapolis, MN.|baseline, 24 weeks|||change in percent kcal obtained orally||Standard Deviation|Mean
60169|NCT01206439|Secondary|Exercise Tolerance|Changes in exercise tolerance and time from baseline to 180 days.|Baseline to day 180.||||||
60170|NCT01206439|Primary|Change in Systolic and Diastolic Myocardial Function|Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.|Baseline to day 180|Insufficient data to analyze.|||||
60171|NCT01206387|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28|"Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis~The Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~For the %Body Surface Area Affected the Rule of Nine was be used.~Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline]."|Baseline and 28 days|Base on intention to treat. All participant with Mean Change from Baseline in %BSA affected at Day 28||percentage of body surface area affected||Standard Deviation|Mean
60172|NCT01206387|Secondary|Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)|"Mean Change from Baseline in TLSS (ITT)~TLSS of psoriasis is a score based on physician assessment of disease severity averaged over all lesions from baseline and at Day 28. The TLSS score were graded for induration, erythema and scaling; range: from 0 (Clear) to 5 (Very Severe).~The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance."|Baseline and 28 days|Base on intention to treat. All participant with mean change from baseline in TLSS at Day 28||units on a scale||Standard Deviation|Mean
60173|NCT01206387|Secondary|Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.|"In the Physician Global Assessment of psoriasis is a score based on physician assessment of disease severity averaged over all lesions from baseline and at Day 28. The PGA score were graded for induration, erythema and scaling; range: from 0 (Clear) to 5 (Very Severe).~The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined."|Baseline and 28 days|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed||units on a scale||Standard Deviation|Mean
60174|NCT01206387|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).|28 days|||participants|||Number
60175|NCT01206387|Primary|Clinical Success|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Primary Efficacy Analysis at Day 28 Clinical Success (ITT)||participants|||Number
60176|NCT01206322|Primary|Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg)."|Acute changes within 2 hours|||ml/100g/min/mmHg||Standard Deviation|Mean
60177|NCT01206322|Primary|Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg).~Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order.~Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo."|Acute changes within 2 hours|||T-score||Standard Deviation|Mean
60178|NCT01206140|Secondary|4 -Month Progression-free Survival Rate.|Progression-free survival rate was calculated using the survival distribution function, and 95% confidence limits were calculated using the log-log transformation. Progression was defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Four months|||percent of participants||95% Confidence Interval|Number
60179|NCT01206140|Secondary|Number of Participants With Objective Response|Response evaluated using the Choi criteria. CR - disappearance of all lesions and no new lesions; PR - a decrease in size (the sum of longest diameters of target lesions as defined in RECIST) of 10% or more or a decrease in tumor density (HU) of 15% or more on CT and no new lesions and no obvious progression of nonmeasurable disease; SD - does not meet the criteria for CR, PR, or PD and no symptomatic deterioration attributed to tumor progression; PD - an increase in tumor size of 10% or more and does not meet criteria of PR by tumor density (HU) on CT or new lesions or new intratumoral nodules or increase in the size of the existing intratumoral nodules. Objective response = CR+PR.|Evaluated for response after every two cycles, up to 4.5 years.|||participants|||Number
60180|NCT01206140|Primary|Progression-free Survival|Progression-free survival was estimated using the product-limit method of Kaplan and Meier. Progression wasl evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Until disease progression or death, up to 4.5 years|||months||95% Confidence Interval|Median
60181|NCT01206101|Secondary|Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)|Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
60182|NCT01206101|Secondary|Change in Islet Cell Yield During Culture|Change in islet cell yield from pre-culture to post-culture|From 0 hours pre-culture to 24 hours to 72 hours|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
60183|NCT01206101|Secondary|Proportion of Insulin-Independent Subjects|Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation|At 52 weeks after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
60184|NCT01206101|Secondary|Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events|Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events|From week 0 to week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
60185|NCT01206101|Secondary|Number of Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself).|During week 0 to week 52|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
60186|NCT01206101|Primary|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.|At week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.|||||
60187|NCT01205828|Secondary|Biomarker Analysis|To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.|6 months|Since the treatment showed no significant efficacy against HCC, therefore study of biomarker that predict responsiveness of the treatment was not carried out.|||||
60188|NCT01205828|Secondary|Number of Participants Who Had Grade 3 or 4 Adverse Events|Record of all toxicities graded according to the NCI CTCAE version 3.0|6 months|grade 3 or 4 adverse events||participants|||Number
60189|NCT01205828|Secondary|Progression Free Survival|The number of months between a patient's enrollment and his/her disease progression|2 years|||months||95% Confidence Interval|Median
60190|NCT01205828|Secondary|Overall Survival|the number of months between a patient's enrollment and his/her date of death|2 years|||months||95% Confidence Interval|Median
60193|NCT01205685|Secondary|Number of Participants With Tumor Response Per RECIST|Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|Every 12 weeks to tumor progression|Patients who were available for measurement of tumor response.||participants|||Number
60194|NCT01205685|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.|Every 4 weeks up to 24 weeks|Patients who received treatment and experienced an adverse event.||participants|||Number
60195|NCT01205685|Primary|Anti-tumor Activity of OSI-906|Time to progression measured in months from study entry to date of disease progression|From study entry to 6 months|Patients who received treatment and who were available for determination of disease progression. One patient withdrew after beginning of treatment and was not available for determination of the duration of disease progression.||months||Full Range|Median
60196|NCT01204671|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
60197|NCT01204671|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
60198|NCT01204671|Secondary|Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
60199|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
60200|NCT01204671|Secondary|Number of Days With Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (> =) 37.5 degrees Celsius (°C)].|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Day||Inter-Quartile Range|Median
60201|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Subject|||Number
60202|NCT01204671|Secondary|Number of Days With Solicited Local Symptoms|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Day||Inter-Quartile Range|Median
60203|NCT01204671|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.||Subject|||Number
60243|NCT01205581|Secondary|Comparison of Geometric Mean Titer (GMT) by HAI|Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||Titers||Full Range|Geometric Mean
61203|NCT01195090|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||mg/dl||Standard Error|Least Squares Mean
60204|NCT01204671|Secondary|Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease|Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using “fold increase” as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
60205|NCT01204671|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subject|||Number
60206|NCT01204671|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease|A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subject|||Number
60207|NCT01204671|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subject|||Number
60208|NCT01204671|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
60209|NCT01204658|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|During the entire study period (Months 0-11)|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.||Subjects|||Number
60210|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) – Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases.||Subjects|||Number
60211|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) – Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.||Subjects|||Number
60212|NCT01204658|Secondary|Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination – Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C.|Within the 7-day (Days 0-6) period post vaccination after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
60213|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
60214|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Primary Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
60215|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Booster Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
60216|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Primary Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
60217|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
60218|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
60244|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After Second Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination|||Events|||Number
60245|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After First Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination|||Events|||Number
60246|NCT01205581|Secondary|Number of Local Reactogenicity Events After Second Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination|||Events|||Number
60219|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Booster Phase of the Study|"Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study.~* A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™."|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||mIU/mL||95% Confidence Interval|Geometric Mean
60220|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||mIU/mL||95% Confidence Interval|Geometric Mean
60221|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Booster Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
60222|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Primary Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
60223|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||IU/mL||95% Confidence Interval|Geometric Mean
60224|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||IU/mL||95% Confidence Interval|Geometric Mean
60225|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Booster Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)||12/2050||||
60226|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Primary Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)||12/2050||||
63855|NCT01172600|Secondary|Usage of Opioid||3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 2nd block.||participants|||Number
60227|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study. Results for humoral immune response to the opsonophagocytic activity testing for OPA-19A will be updated when validated results become available.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
60228|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study. Results for humoral immune response to the opsonophagocytic activity testing for OPA-19A will be updated when validated results become available.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||Titers||95% Confidence Interval|Geometric Mean
60229|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes – Booster Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
60230|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes – Primary Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||µg/mL||95% Confidence Interval|Geometric Mean
60231|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) – Booster Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
60232|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) – Primary Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
60247|NCT01205581|Secondary|Number of Local Reactogenicity Events After First Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination|||Events|||Number
60248|NCT01205581|Secondary|Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.||percentage of participants|||Number
60233|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Booster Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
60234|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Primary Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).||EL.U/mL||95% Confidence Interval|Geometric Mean
60235|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Percentage of participants|||Number
60236|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Percentage of participants|||Number
60237|NCT01204658|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination – Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.||Subjects|||Number
60238|NCT01205646|Secondary|Changes in Bone Turnover Markers||Four weeks after initiating zoledronte therapy||||||
60239|NCT01205646|Secondary|Evaluate Changes in Bone Scans||Four weeks after initiating zoledronate therapy||||||
60240|NCT01205646|Secondary|Evaluate the Change in PSA After Zoledronate Therapy||Four weeks after initiating Zoledronate therapy||||||
60241|NCT01205646|Primary|PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.|PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a “PET response”. Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.|Within 3 weeks|||Proportion of participants with response||90% Confidence Interval|Number
60242|NCT01205581|Secondary|Comparison of Geometric Mean Ratios (GMR) by HAI|"GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later.~GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later."|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||Ratio|||Number
60286|NCT01205269|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||bpm||Standard Deviation|Mean
60249|NCT01205581|Primary|Number of Participants Achieving Seroprotection After Second Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|21 to 42 days after second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||number of participants|||Number
60250|NCT01205581|Primary|Rate of Seroprotection After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||Percentage of participants|||Number
60251|NCT01205581|Secondary|Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.||percentagae of participants|||Number
60252|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.~The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine|||percentrage of participants|||Number
60253|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.~The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||percentage of participants|||Number
60254|NCT01205581|Secondary|Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD|Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.|From initial vaccine administration through up to 8 months|Adverse events of Fluzone HD and Fluzone are provided as combined data from cancer and HIV patients, since there is no reason to believe one group is more susceptible to adverse events than the other.||participants|||Number
60255|NCT01205581|Primary|Rate of Seroconversion After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.||percentage of participants|||Number
60256|NCT01205503|Secondary|B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||pg/ml||95% Confidence Interval|Geometric Mean
60257|NCT01205503|Secondary|Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||ng/ml||95% Confidence Interval|Geometric Mean
60258|NCT01205503|Secondary|Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
60259|NCT01205503|Secondary|Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
60260|NCT01205503|Primary|TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2|||log(pg/ml)||95% Confidence Interval|Geometric Mean
60261|NCT01205451|Secondary|Mean Change From Baseline in Pulse Rate at the Exit Visit|The pulse rate of participants was recorded. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Screening) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||beats per minute||Standard Deviation|Mean
60287|NCT01205269|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||bpm||Standard Deviation|Mean
60262|NCT01205451|Secondary|Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit|Systolic blood pressure (SBP) and diastolic BP of participants were measured in the sitting position. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
60263|NCT01205451|Secondary|Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits|Urine samples of participants were collected for urinalysis, including measuring protein, blood, leukocyte, glucose, and urobilinogen. All values out of the normal range were evaluated by the investigator. Classification of clinically significant and not clinically significant was based on the investigator’s clinical judgment; no specific criteria were used.|Screening visit (-Week 1) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Screening and exit visits were analyzed.||participants|||Number
60264|NCT01205451|Secondary|Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit|Blood samples of participants were collected for biochemical tests of BUN, FBG, electrolytes, cholesterol, and triglycerides. The BUN test is primarily used to evaluate kidney function. Electrolytes include sodium, potassium, and chloride. Change from Baseline was calculated as the value at the exit visit minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
60265|NCT01205451|Secondary|Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of creatine, uric acid, and total bilirubin. Creatine and uric acid are evaluated for kidney function. The liver function test includes total bilirubin. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Micromoles per Liter (μmol/L)||Standard Deviation|Mean
60266|NCT01205451|Secondary|Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit|Blood samples of participants were collected and evaluated for liver function, including measuring ALT, AST, y-GT, and ALP. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||International Units per Liter (IU/L)||Standard Deviation|Mean
60267|NCT01205451|Secondary|Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of total protein and albumin, at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||grams/L||Standard Deviation|Mean
60268|NCT01205451|Secondary|Mean Change From Baseline in Hematocrit Value at the Exit Visit|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||percentage||Standard Deviation|Mean
60269|NCT01205451|Secondary|Mean Change From Baseline in Hemoglobin Content at the Exit Visit|Blood samples of participants were collected and evaluated for hemoglobin at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Grams per Liter (grams/L)||Standard Deviation|Mean
60270|NCT01205451|Secondary|Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit|Blood samples of participants were collected and evaluated for the percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils comprising the total WBC count in the blood at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||Percentage of the total WBC||Standard Deviation|Mean
60271|NCT01205451|Secondary|Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit|Blood samples of participants were collected and evaluated for WBC count and platelet count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||10^9 cells per Liter||Standard Deviation|Mean
60272|NCT01205451|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit|Blood samples of participants were collected and evaluated for RBC count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and exit visit (Week 12 or earlier)|Safety Set Population: all enrolled and treated participants. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.||10^12 cells per Liter||Standard Deviation|Mean
60288|NCT01205269|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||mmHg||Standard Deviation|Mean
60273|NCT01205451|Secondary|GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12|The care giver or participant used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
60274|NCT01205451|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
60275|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for the Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
60276|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. Only those participants who had thumb spasticity were analyzed. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
60277|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
60278|NCT01205451|Secondary|Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12|Wrist treatment responders are defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS from Baseline. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||participants|||Number
60279|NCT01205451|Primary|Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|Full Analysis Set (FAS) Population: all randomized and treated participants with at least one post-treatment MAS wrist score. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.||scores on a scale||Standard Deviation|Mean
60280|NCT01205399|Secondary|Procedural Time for AlloMax Surgical Graft Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|0 Days|All enrolled subjects that could be verified through historical medical record review.||minutes||Standard Deviation|Mean
60281|NCT01205399|Secondary|Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject’s medical files from the time surgery was initiated until the day the subject had a postoperative visit.|9+ Months|All enrolled subjects that could be verified through historical medical record review.||complication events|||Number
60282|NCT01205399|Primary|Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft|A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|9 + Months|All enrolled subjects that could be verified through historical medical record review.||participants|||Number
60283|NCT01205269|Secondary|Plasma AZD8683 AUC0-24|Area under the AZD8683 plasma concentration curve from 0 to 24 hours|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.||nmol*h/L||Full Range|Geometric Mean
60284|NCT01205269|Secondary|Plasma AZD8683 Cmax|Maximum plasma concentration of AZD8683|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.||nmol/L||Full Range|Geometric Mean
60285|NCT01205269|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||ms||Standard Deviation|Mean
60293|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables||L||Standard Deviation|Mean
60294|NCT01205230|Secondary|Number of Participants With the Indicated Event of Dose Limiting Toxicity (DLT)|The following were considered DLTs only while participants were receiving pazopanib co-administered with either ketoconazole or esomeprazole: Grade 4 hematologic toxicities, excluding lymphopenia; and Grade 3/4 non-hematologic toxicities, excluding alopecia and nausea/vomiting/diarrhea for which adequate supportive therapy had not been instituted. Toxicities observed once co-administration of pazopanib with ketoconazole or esomeprazole was complete (after Day 5 of Period 2) could also be considered DLTs if judged to be relevant by the investigator and the GlaxoSmithKline Medical Monitor.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population. Per protocol, a DLT could not occur during single-agent pazopanib administration in Period 1; thus, data were only collected and analyzed for those participants receiving pazopanib co-administered with either ketoconazole or esomeprazole in Period 2.||participants|||Number
60295|NCT01205230|Secondary|Number of Participants With the Indicated Grade 3 or 4 Adverse Events (AEs)|AEs were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. Grades range from 0 (no toxicity) to 4 (life-threatening or disabling). A Grade 3 AE is severe; defined as considerable interference with the participant’s daily activities, medical intervention/therapy required, and hospitalization possible. A Grade 4 AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, and hospitalization probable.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population: all participants who were enrolled into the study and received at least one dose of study drug||participants|||Number
60296|NCT01205230|Secondary|Plasma Ketoconazole Concentration at the Indicated Time Points|Blood samples for the determination of plasma ketoconazole concentrations were collected before (pre-dose [within 60 minutes prior to pazopanib administration]) and after the final pazopanib and ketoconazole dose (fifth dose) during Period 2 at the indicated time points, relative to pazopanib administration (at 1 and 2 hours after pazopanib administration). Blood samples were obtained via peripheral intravenous cannula or central line. Concentrations of ketoconazole were determined in plasma samples using the currently approved analytical methodology.|Day 5 of Period 2 (combination therapy). Blood samples were collected within 60 minutes prior to pazopanib administration and 1 and 2 hours after pazopanib administration.|PK Population||mcg/mL||Full Range|Mean
60297|NCT01205230|Secondary|Tmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||hr||Full Range|Median
60298|NCT01205230|Secondary|Plasma Cmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||mcg/mL||95% Confidence Interval|Geometric Mean
60299|NCT01205230|Secondary|Plasma AUC(0-24) for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population. One participant from the Pazopanib + Ketoconazole treatment arm was not analyzed for GSK1071306 due to mishandling of PK samples during shipping. Only those participants providing samples were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
60300|NCT01205230|Secondary|Plasma Concentration at 24 Hours After Administration (C24) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Pazopanib plasma concentration-time data were analyzed by non-compartmental methods with WinNonlin. Calculations were based on the actual sampling times. From the plasma concentration-time data, the PK parameter C24 was determined.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained 24 hours after administration of pazopanib.|PK Population||mcg/mL||95% Confidence Interval|Geometric Mean
60321|NCT01204853|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|12 weeks|"Safety analysis set is defined as all participants who receive at least one dose of the study drug.~Descriptive statistics for adverse events were not calculated due to a small number of subjects."||Participant|||Number
60674|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 20||Baseline (Day 1) and Week 20|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 20||log10 Copies/mL||Full Range|Median
60301|NCT01205230|Primary|Time of Occurrence of Cmax (Tmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||hours (hr)||Full Range|Median
60302|NCT01205230|Primary|Plasma Maximum Observed Concentration (Cmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population||mcg/mL||95% Confidence Interval|Geometric Mean
60303|NCT01205230|Primary|Plasma Pazopanib Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC[0-24]) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for pharmacokinetic (PK) analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|Pharmacokinetic (PK) Population: all participants who underwent plasma PK sampling and had evaluable PK assay results from at least one analyte||Hour*micrograms/milliliters (hr*mcg/mL)||95% Confidence Interval|Geometric Mean
60304|NCT01205126|Secondary|Breakthrough Pain Medication (Rescue Medication) Doses Taken|Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain.|Baseline up to Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy. Redefined LOCF was applied. Here 'N' =number of participants who were evaluated for this outcome measure.||Doses||Standard Deviation|Mean
60305|NCT01205126|Secondary|Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
60306|NCT01205126|Secondary|Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
60307|NCT01205126|Secondary|Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
60308|NCT01205126|Secondary|Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.||Units on a scale||Standard Deviation|Mean
60322|NCT01204788|Primary|Number of Participants With Infection|Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.|Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.|Outcomes inevaluable due to low recruitment.|||||
60435|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Species|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60309|NCT01205126|Primary|Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|Per protocol set (PPS) included all randomly assigned participants who had completed all efficacy evaluations, and participants who prematurely discontinued the study due to lack of efficacy were also included. Redefined last observation carried forward (LOCF) was applied. Redefined LOCF is LOCF prior to over dose rescue medication.||Units on a scale||Standard Deviation|Mean
60310|NCT01205035|Secondary|Angiographic Leakage From Baseline to Month 6 and 12|"Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 6. Also any decreases of angiographic leakage was counted between baseline and 6 month. The same was done between baseline and 12 month.~Any increase of angiographic leakage was counted as a +1. Likewise, any decrease of angiographic leakage was counted as a -1. The sum was calculated based on the number of participants in each arm and the total shown in the outcome. For example: if across the three injected participants for their 6 month visit, two of them showed an increase of angiographic leakage and one showed a decrease, then the outcome would be, (+1) + (+1) + (-1)= +1. Likewise, if the same three participant's 12 month visit showed two with a decrease in leakage and one with no changes in leakage, the outcome would be, (-1) + (-1) + (0)= -2"|Baseline to 6 and baseline to 12 months|||Sum of increases (+1) and decreases (-1)|||Number
60311|NCT01205035|Secondary|Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg||Baseline to 6 month, baseline to 9 month and baseline to 12 months|||Number of Adverse Events|||Number
60312|NCT01205035|Secondary|Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months|A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.|Baseline to 6, 9, and 12 months|||Micrometer||Full Range|Mean
60313|NCT01205035|Secondary|Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months||Baseline to 6 months and baseline to 9 months|||LogMAR Unit||Full Range|Mean
60314|NCT01205035|Primary|Visual Acuity Change From Baseline to Month 12 of the Study||Baseline to 12 months|||LogMAR Unit||Full Range|Mean
60315|NCT01204853|Secondary|Number of Participants With Pharmacokinetic (PK) Parameters at Steady State|The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination.|pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination|"The PK concentration set was defined as all participants who have at least 1 concentration.~The PK parameter analysis set was defined as all participants who have at least 1 of PK parameters of interest.~Descriptive statistics for PK parameters were not calculated due to a small number of participants."||Participants|||Number
60316|NCT01204853|Secondary|Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for clinical worsening were not calculated due to a small number of participants."||Participants|||Number
60317|NCT01204853|Secondary|Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in NT-pro BNP were not calculated due to a small number of participants."||pg/mL||Standard Deviation|Mean
60318|NCT01204853|Secondary|Number of Participants With Haemodynamics Parameters|"The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate.~Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline."|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in haemodynamics parameters were not calculated due to a small number of participants."||Participants|||Number
60319|NCT01204853|Secondary|Change From Baseline in WHO Functional Class|The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. The change from baseline in WHO functional class at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in WHO functional class were not calculated due to a small number of participants."||Percentage of participants|||Number
60320|NCT01204853|Primary|Change From Baseline in 6-minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in 6-minute walk distance were not calculated due to a small number of participants."||Meters||Standard Deviation|Mean
60436|NCT01202253|Secondary|Infecting Organisms by Species||Baseline up to Day 14 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
60323|NCT01204736|Primary|Elbow Extension Strength|Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.|At least one year post surgery|||Newton-Meters|Participants|Standard Deviation|Mean
60324|NCT01204697|Secondary|Duration of Response (DoR)|Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death ‐ Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan‐Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population. Here, number of participants analyzed signifies those participants who had a best overall response of CR or PR.||months||95% Confidence Interval|Median
60325|NCT01204697|Secondary|Percentage of Participants With Disease Control|Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non‐responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population||percentage of participants||95% Confidence Interval|Number
60326|NCT01204697|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [>=] 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization until progressive disease or death, assessed up to 18 months|FAS population||percentage of participants||95% Confidence Interval|Number
60327|NCT01204697|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan‐Meier method.|From randomization until death, assessed up to 18 months|FAS population||months||95% Confidence Interval|Median
60328|NCT01204697|Secondary|Progression-free Survival (PFS)|Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression‐free. Participants without post‐baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event ‐ Date of Randomization) + 1. PFS was assessed using the Kaplan‐Meier method. Detailed definition of PD is provided in Outcome Measure 1.|From randomization until progressive disease or death, assessed up to 18 months|FAS population||months||95% Confidence Interval|Median
60329|NCT01204697|Primary|Percentage of Participants Free From Disease Progression or Death at 6 Months|According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).|Month 6|FAS population||percentage of participants||95% Confidence Interval|Number
60330|NCT01204398|Secondary|Change From Baseline to End of Study in In-clinic Pulse Rate||8 weeks|TS with non-missing data||beats per minute (bpm)||Standard Deviation|Mean
60331|NCT01204398|Secondary|Treatment Emergent Adverse Events|Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events|8 weeks|Treated Set (TS) defined as all patients who entered the run-in phase and were treated with T80/A5.||Participants|||Number
60332|NCT01204398|Secondary|ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing|DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment|0 and 8 weeks|FAS||mmHg||Standard Deviation|Mean
60333|NCT01204398|Secondary|Change From Baseline to End of Study in DBP and SBP|Manually measured in-clinic DBP and SBP|8 weeks|FAS||mmHg||Standard Deviation|Mean
60334|NCT01204398|Secondary|Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment|Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.|8 weeks|FAS||Ratio||Full Range|Median
60335|NCT01204398|Secondary|Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing|Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5|8 weeks|FAS||mmHg||Standard Deviation|Mean
60336|NCT01204398|Primary|DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean|ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.|8 weeks|Full analysis set (FAS) defined as all patients with at least one dose of T80/A5, and for whom baseline and post-baseline ABPM are available.||mmHg||Standard Deviation|Mean
63856|NCT01172600|Secondary|Usage of Opioids||2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.||participants|||Number
60337|NCT01204294|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.|Baseline and 52 weeks|The full analysis set (FAS) comprised all treated patients who had baseline HbA1c measurement and at least one on-treatment HbA1c measurement available||Percentage||Standard Deviation|Mean
60338|NCT01204294|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events|The first drug administration through 7 days after the last drug administration, up to 382 days|The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period||Patients|||Number
60339|NCT01204255|Secondary|Side Effects||3 months||||||
60340|NCT01204255|Primary|Lorazepam, Diphenyhydramine, Haloperidol Absorption|Level of lorazepam absorption measured by the serum concentration of the drug|4 hours|||ng/ml||Standard Deviation|Mean
60341|NCT01203956|Secondary|Key Measures That Will be Used to Evaluate the Intervention(s)|The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device|2 weeks||||||
60342|NCT01203956|Primary|Apnea-hypopnea Index (AHI)|Number of apnea/hypopnea events per hour, measured by SmartLink component of device.|4 weeks|||events / hour||Standard Deviation|Mean
60343|NCT01203917|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Months||95% Confidence Interval|Median
60344|NCT01203917|Other Pre-specified|Progression - Free Survival (PFS) (Independent Central Review)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Months||95% Confidence Interval|Median
60345|NCT01203917|Secondary|Progression - Free Survival (PFS) (Investigator)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Months||95% Confidence Interval|Median
60346|NCT01203917|Other Pre-specified|Objective Response Rate (ORR) (Independent Central Review))|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
60347|NCT01203917|Other Pre-specified|Disease Control Rate (DCR) (Independent Central Review)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
60348|NCT01203917|Secondary|Disease Control Rate (DCR) (Investigator)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
60370|NCT01203098|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment||percentage of subjects with bleeds||95% Confidence Interval|Number
60437|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan||Baseline|Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available.|||||
99752|NCT00816036|Secondary|Prescription of Recommended Pharmacotherapy for Smoking Cessation||Assessed within 72 hours of hospital discharge|||participants|||Number
60349|NCT01203917|Primary|Objective Response Rate (ORR) (Investigator)|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib||Percentage of Participants|||Number
60350|NCT01203878|Secondary|Cosmetic Appearance|"Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments:~INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation~1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity"|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 investigator cosmetic appearance score. One imiquimod/observation patient did not have an end of study investigator cosmetic appearance score.||units on a scale||Standard Deviation|Mean
60351|NCT01203878|Secondary|Complete Clearance|The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).|Week 18 (4 weeks after randomization visit)|Randomized patients with a week 18 actinic keratosis count.||participants|||Number
60352|NCT01203878|Primary|Actinic Keratosis Count|The percent change in actinic keratosis count as compared to the baseline lesion count|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 actinic keratosis count. One patient in imiquimod/observation group did not have a baseline count and therefore was not included in the analysis.||percent reduction in baseline count||Standard Deviation|Mean
60353|NCT01203852|Secondary|Adverse Metabolic Effects|Change in glucose after treatment with study medication|after 6-8 weeks treatment|All patients with change in glucose data||mg/dL||Standard Deviation|Mean
60354|NCT01203852|Primary|Change in Blood Pressure From Baseline to Treatment|Response to blood pressure medication will be assessed by measuring blood pressure before and after treatment|after 6-8 weeks of treatment|All patients with antihypertensive response data. 282 patients completed all 3 study periods. 369 patients completed only period 1. 328 patients completed only period 3.||mmHg||Standard Deviation|Mean
60355|NCT01203787|Secondary|Number of Subjects With Dose Reductions||11/22/2010-3/10/2014|||participants|||Number
60356|NCT01203787|Secondary|Number of Subjects With Dose Interruptions||Baseline-End of Treatment (11/22/2010-3/10/2014)|||participants|||Number
60357|NCT01203787|Primary|Cumulative Dose of Sorafenib|Table below shows mean cumulative dose of sorafenib for each of the dosing regimens.|11/22/2010-1/27/14|||mg||Standard Deviation|Mean
60358|NCT01203787|Secondary|Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 5 adverse events was collected for each dosing regimen beginning at baseline through 6 months of treatment.|11/22/2010-3/10/2014|||Grade 5 Adverse Events|||Number
60359|NCT01203787|Secondary|Safety of Dosing Regimens as Assessed by the Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 4 adverse events was collected for each dosing regimen beginning at baseline until Week 24/Early Termination Visit.|11/22/2010-3/10/2014|||Grade 4 adverse events|||Number
60360|NCT01203787|Secondary|Safety and Efficacy of Sorafenib Dosing Regimens|Safety of Sorafenib was assessed by the frequency and severity of adverse events according to NCI-CTCAE grading|Baseline-End of Treatment (11/22/2010-3/10/2014)|The total number of CTCAE (Common Terminology Criteria) grade 3 adverse events was collected for each dosing regimen||Grade 3 adverse events|||Number
60361|NCT01203787|Primary|Total (Cumulative) Dose Delivery of Sorafenib|This outcome measure table shows the median cumulative dose delivered to the subjects randomized to the standard dosing regimen (N=63) and ramp-up regimen (N=57) at 4 months of treatment.|4 months-1/12/2010-1/27/14|||mg||Full Range|Median
60362|NCT01203644|Secondary|Adverse Events|Safety assessments included monitoring of treatment-emergent adverse events|Through 30 days postdose||||||
60363|NCT01203644|Primary|Time to First Use of Supplemental Pain Medication|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain|Through 96 hours postdose|||hours||Inter-Quartile Range|Median
60364|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after third vaccination|within the first 30 days after third vaccination||||||
60365|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after second vaccination|within the first 30 days after second vaccination||||||
60366|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after first vaccination|within the first 30 days after first vaccination||||||
60367|NCT01203319|Secondary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after first vaccination|one month after the first vaccination|||participants|||Number
60368|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination|one month after the third vaccination|||participants|||Number
60369|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination|one month after the second vaccination|Accroding to Protocol set||participants|||Number
60675|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 16||Baseline (Day 1) and Week 16|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 16||log10 Copies/mL||Full Range|Median
60371|NCT01203098|Primary|Percentage of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.||percent of participants with VTE event||95% Confidence Interval|Number
60372|NCT01203072|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug|2 weeks|Safety Analysis Set is defined as subjects secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any doses of study drug, or had no safety data after start of study treatment. Subjects with significant GCP violations, but received at least one dose of study drug, safety data were assessed individually||percentage of subjects with bleeds||95% Confidence Interval|Number
60373|NCT01203072|Primary|Proportion of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.||percentage of participants||95% Confidence Interval|Number
60374|NCT01203046|Primary|Other Complications|Patients with complications different to surgical site infection.|10 days|Patients who presented any complication different of surgical site infection after surgery||participants|||Number
60375|NCT01203046|Primary|Surgical Site Infection|The patients were evaluated up to 10 days with close observation of surgical site. We concluded as surgical site infection when inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption was observed.|10 days|All patients with inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption observed at surgical site were included.||participants|||Number
60376|NCT01202955|Secondary|Correct Reaction Time During Attention Task Performance After Overnight Abstinence.|We wanted to examine the effects of Tolcapone on the Continuous Performance Task (attention task) after overnight abstinence as compared to placebo.|30 days|Only participants who completed both study phases were analyzed.||Milliseconds||Standard Deviation|Mean
60377|NCT01202955|Secondary|N-back (Working Memory) Correct Reaction Time After Overnight Abstinence.|To obtain preliminary data on the effects of Tolcapone on abstinence-induced neurocognitive deficits in abstinent smokers with differing COMT genotypes. We examined reaction time differences on the n-back task between tolcapone and placebo treatment.|30 days|Only participants who completed both sessions were analysed||Milliseconds||Standard Deviation|Mean
60378|NCT01202955|Primary|Number of Eligible Participants Enrolled Who Completed the Study.|Number of enrolled participants who complete the final study visit|30 days|Number of Participants who completed the study.||Participants|||Number
60379|NCT01202903|Secondary|Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment|Analysis of rescue medication use followed a similar method to that employed for total asthma symptom score. The mean number of puffs across the 28 days prior to the Week 24 assessment visit was used to calculate a change from baseline. LS Mean of change from baseline in mean number of puffs of asthma rescue medication is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean number of puffs of asthma rescue medication as covariates.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Number of puffs||Standard Error|Least Squares Mean
60380|NCT01202903|Secondary|Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24|The global evaluation of treatment effectiveness (GETE) is an assessment of asthma symptom control and overall response to asthma treatment. The evaluation was performed by both investigator and patient, each using the same 5 point scale. The GETE scale ranges were as follows: excellent, good, moderate, poor and worsening. A good or excellent response on the 5 point scale indicated that a patient had responded to treatment. 1=excellent 2=good 3=moderate 4=poor 5= worsening. Responder is defined as the patient who achieved an excellent or good response. Non-responder isdefined as the patient who achieved a moderate or poor or worsening response.|16 and 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Percent|||Number
60381|NCT01202903|Secondary|Change From Baseline in Asthma Symptom Scores Following 24-week Treatment|Total asthma symptom score was derived for each day as the total of the morning (scale 0-1), daytime (scale 0-4) and nocturnal (scale 0-4) scores with a max score of 9. The mean score across the 28 days prior to the week 24 assessment visit was used to calculate a change from baseline. Analysis of total asthma symptom score was performed using ANCOVA model and Van-Elteren test. LS Mean of change from baseline in mean asthma symptom score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean asthma symptom scores as covariates. Decrease of score on change from baseline means improvement of asthma symptom control.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Units on a scale||Standard Error|Least Squares Mean
61204|NCT01195090|Secondary|Change in Fasting Total-cholesterol|Total-cholesterol change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
60382|NCT01202903|Secondary|Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator’s site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. Only patients with no more than 1 item missing are included, and the missing item was imputed by interpolation|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Percent|||Number
60383|NCT01202903|Secondary|Change From Baseline in ACQ Score Following 24-week Treatment|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator’s site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. LS Mean of change from baseline in ACQ score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, center grouping, smoking status, and baseline ACQ score as covariates. Score 0= totally controlled, 6= extremely poorly controlled|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Units on a scale||Standard Error|Least Squares Mean
60384|NCT01202903|Secondary|Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients’ asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Percent|||Number
60385|NCT01202903|Secondary|Change From Baseline in AQLQ Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients’ asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||Units on a scale||Standard Error|Least Squares Mean
60386|NCT01202903|Secondary|Change From Baseline in % Predicted FEV1 Following 24-week Treatment|Spirometry was used at defined time points throughout the study to assess the clinical status of patients and to capture the following variables: forced expiratory volume in one second (FEV1), FEV1 percent predicted, forced vital capacity (FVC) and the FEV1/FVC ratio. During the Screening assessment, spirometry was performed pre- and post-bronchodilator administration to assess reversibility. During the treatment period (including prerandomization assessments on Day 1), spirometry was performed after withholding bronchodilators. The results of spirometry were required to meet the ATS/ERS criteria for acceptability and repeatability. Acceptability criteria were applied before repeatability was determined. LS Mean of change from baseline in % predicted FEV1 is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline % predicted FEV1 as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||L/min||Standard Error|Least Squares Mean
60387|NCT01202903|Secondary|Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||L/min||Standard Error|Least Squares Mean
60402|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and DLQI data available. LOCF was used.||correlation coefficient|||Number
60388|NCT01202903|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days||L/min||Standard Error|Least Squares Mean
60389|NCT01202877|Primary|Overall Response (OR) Within 6 Months|Overall response defined as percentage of participants with response as follows: (OR = CR [complete response (CR) rate] + CRi [complete remission with incomplete count recovery] + PR [partial remission] + HI [hematologic improvement]) within 6 months of treatment initiation|6 Months|||percentage of participants|||Number
60390|NCT01202877|Primary|Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|Criteria for response per international working group for Myelodysplastic Syndrome (MDS) & acute myeloid leukemia (AML) where responders obtained a complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: <5% bone marrow blasts, neutrophil count>1.0 X10⁹/L, & platelet count>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (<1.0 X10⁹/L) or thrombocytopenia (<100 X10⁹/L). MLFS: <5% blasts in bone marrow regardless of neutrophil & platelet count in peripheral blood. PR: all CR criteria, except reduction> 50% in bone marrow blasts, but still >5%. Clinical responses evaluated using RECIST version 1.1 criteria after every two cycles, with confirmation of clinical response at 4 weeks after achieving response.|6 months|||participants|||Number
60391|NCT01202747|Primary|Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)|"Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.~Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction."|Baseline and 4 Weeks|Results presented are for the Intent to Treat population.||Correlation coefficient|||Number
60392|NCT01202656|Secondary|Live Birth Rates|Live birth rates among normal infertile couples undergoing IVF|Within nine months of embryo transfer|||Live Birth|||Number
60393|NCT01202656|Primary|Embryo Implantation and Clinical Pregnancy Rates|"Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred~Clinical pregnancy:~Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer"|26 to 30 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.||Gestational sacs|Participants||Number
60394|NCT01202643|Secondary|Implantation Rate|Number of gestational sacs per number of embryos transferred in each treatment group|28 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.||Gestational sacs|Participants||Number
60395|NCT01202643|Primary|Endometrial Thickness|Thickness of the endometrium on the day of embryo transfer|Day of embryo transfer|||mm||Standard Deviation|Mean
60396|NCT01202591|Primary|Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)||3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).|All patients who receive at least one dose of study treatment (AZD4547 or exemestane)||Participants|||Number
60397|NCT01202578|Secondary|Tube Retention|Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.|7 days|Tube retention was assessed for all TT successfully placed by the TTDS||percentage of tubes retained|Participants|95% Confidence Interval|Number
60398|NCT01202578|Secondary|Proportion of Subjects With Procedure Success|Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.|0 days|||percentage of participants||95% Confidence Interval|Number
60399|NCT01202578|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.|0 days|Device Success is evaluated on a per device basis.||percentage of devices|Participants|95% Confidence Interval|Number
60400|NCT01202578|Primary|Safety of Tympanostomy Tube (TT) Delivery System|Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.|7 days|Subjects in whom TTDS was attempted.||percentage of ears|Participants|95% Confidence Interval|Number
60401|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Quality of Life|Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Full Analysis Set; participants with both PASI and DLQI data available. LOCF was used.||correlation coefficient|||Number
60403|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and DLQI data available. LOCF was used.||correlation coefficient|||Number
60404|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and PASI data available. LOCF was used.||correlation coefficient|||Number
60405|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and PASI data available. LOCF was used.||correlation coefficient|||Number
60406|NCT01202565|Secondary|Change From Baseline in DLQI Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline DLQI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
60407|NCT01202565|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.||percent change||Standard Deviation|Mean
60408|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 50 Response|"The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
60409|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 75 Response|"The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
60410|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 90 Response|"The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
60434|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Colonization Index||Baseline|Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants.|||||
60411|NCT01202565|Secondary|Change From Baseline in PASI Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
60412|NCT01202565|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.||percent change||Standard Deviation|Mean
60413|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Scalp|Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.|Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
60414|NCT01202565|Secondary|Percentage of Participants Achieving Good Clinical Response on Scalp|"Good clinical response on scalp is defined as a ≥ 50% improvement from Baseline in PSSI score.~The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area."|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
60415|NCT01202565|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
60416|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Nails|"Complete clearing of nails is defined as a total NAPSI score of zero.~The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
60417|NCT01202565|Secondary|Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis|"Good clinical response on nails is defined as ≥ 50% improvement from Baseline in total NAPSI score.~The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||percentage of participants|||Number
60438|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Microbiological Analysis|Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
60418|NCT01202565|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).~A negative change from Baseline indicates improvement."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."||units on a scale||Standard Deviation|Mean
60419|NCT01202565|Primary|Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12|"The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.~Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Scalp Psoriasis Set (SPS), which includes participants with a Baseline PSSI ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
60420|NCT01202565|Primary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).~Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Nail Psoriasis set, which includes participants with a Baseline NAPSI score ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
60421|NCT01202279|Primary|Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).|WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.|Baseline and 7 Days|||units on a scale||Standard Deviation|Mean
60422|NCT01202279|Primary|Antibiotic Sparing|Number of patients who received an antibiotic|Day 7|Per Protocol Population using Fishers Exact Test.||Participants|||Number
60423|NCT01202253|Secondary|Number of Participants With Different Types of Drug-related Serious Adverse Events||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
60424|NCT01202253|Secondary|Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants|||Number
60425|NCT01202253|Secondary|Number of Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||events|||Number
60426|NCT01202253|Secondary|Duration of Anidulafungin Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||days||Standard Deviation|Mean
60427|NCT01202253|Secondary|Number of Participants With Other Dosing Patterns|The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
60428|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60429|NCT01202253|Secondary|Percentage of Participants Who Received 100 mg Dose on Day 2||Day 2|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60430|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Loading Dose||Day 1|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60431|NCT01202253|Secondary|Percentage of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60432|NCT01202253|Secondary|Number of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||participants|||Number
60433|NCT01202253|Secondary|Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants|||Number
60439|NCT01202253|Secondary|Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60440|NCT01202253|Secondary|Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60441|NCT01202253|Secondary|Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60442|NCT01202253|Secondary|Dose Changes for Immunosuppressant Drugs||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available.|||||
60443|NCT01202253|Secondary|Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60444|NCT01202253|Secondary|Percentage of Participants With Concomitant Bacterial or Viral Infection|Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60445|NCT01202253|Secondary|Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60446|NCT01202253|Secondary|Duration of Stay at Liver Intensive Therapy Unit (LITU)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||days||Inter-Quartile Range|Mean
60447|NCT01202253|Secondary|Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)||Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60448|NCT01202253|Secondary|Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants.|||||
60449|NCT01202253|Secondary|Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy|Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60450|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60451|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60452|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results|A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator’s discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60453|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results|An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator’s discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
61205|NCT01195090|Secondary|Percentages of Patients With Total Adverse Events (AE)|percentages of total adverse events|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis||percentage|||Number
60454|NCT01202253|Secondary|Percentage of Participants With Documented Eradication of Infecting Species|Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.|Baseline|Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants’ medical notes.|||||
60455|NCT01202253|Secondary|Percentage of Participants With Oral Antifungal Started to Complete Therapy||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60456|NCT01202253|Secondary|Percentage of Participants Requiring Change or Additional Antifungal Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60457|NCT01202253|Secondary|Percentage of Participants With Lack of Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
60458|NCT01202253|Secondary|Percentage of Participants With Favorable Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
60459|NCT01202253|Secondary|Percentage of Participants With Death Unrelated to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60460|NCT01202253|Secondary|Percentage of Participants With Death Attributable to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants|||Number
60461|NCT01202253|Secondary|Percentage of Participants Who Died Due to All Causes|Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.||percentage of participants||95% Confidence Interval|Number
60462|NCT01202253|Secondary|Percentage of Participants With Unfavorable Outcome|Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
60463|NCT01202253|Primary|Percentage of Participants With Favorable Outcome|Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
60464|NCT01202227|Secondary|Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score|"The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from “does not interfere” (0) to “completely interferes” (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale.~Change = observation mean at Week 52 minus baseline mean."|Baseline, Week 52|"The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available.~The number of participants who had mBPI at Week 52/ Early Termination was 101 participants (n=101)."||Score on a scale||95% Confidence Interval|Mean
60465|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).||Score on a scale||95% Confidence Interval|Mean
60466|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).||Score on a scale||95% Confidence Interval|Mean
61206|NCT01195090|Secondary|Body Weight Change|body weight change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||kg||Standard Error|Least Squares Mean
60467|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).||Score on a scale||95% Confidence Interval|Mean
60468|NCT01202227|Primary|Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)|The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60469|NCT01202227|Primary|Number of Participants With Deterioration in Neurological Examination Findings|Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60470|NCT01202227|Primary|Number of Participants With Visual Field Deteriorated|Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60471|NCT01202227|Primary|Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60472|NCT01202227|Primary|Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60473|NCT01202227|Primary|Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60474|NCT01202227|Primary|Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60475|NCT01202227|Primary|Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60476|NCT01202227|Primary|Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60477|NCT01202227|Primary|Number of Participants With Generalized or Abdominal Edema|Number of participants who had generalized or abdominal edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60478|NCT01202227|Primary|Number of Participants With Facial/Periorbital Edema|Number of participants who had facial or periorbital edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60479|NCT01202227|Primary|Number of Participants With Peripheral Edema|Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.||Participants|||Number
60480|NCT01202188|Secondary|Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization||26 Weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
60481|NCT01202188|Secondary|Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period||26 Weeks|Full Analysis Set includes all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
60482|NCT01202188|Secondary|Rate of Moderate or Severe COPD Exacerbation|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26 Weeks|||Exacerbations per year|||Number
60483|NCT01202188|Secondary|24 Hour Holter Monitoring in a Subset of Patients|"24-hourly mean heart rate was performed using a Holter Monitor at Weeks 12 and 26 in a subgroup of patients. Mixed model: heart rate = treatment + baseline heart rate + baseline smoking status + baseline ICS use + region + center (region) + error. Center was included as a random effect nested within region.~The 24-hourly mean heart rate is the mean heart rate over the 24 hour period, derived using hourly mean heart rate beats per minute."|Week 12, Week 26|Safety Set Holter Group-a subset of the Safety participants that included all randomized participants who received at least one dose of study drug and participated in the 24 hour Holter monitoring with evaluable data available for analysis. No participants in the Titotropium arm participated in the Holter Monitoring.||beats per minute||Standard Error|Least Squares Mean
60484|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12, 23 hours 15 minutes and 23 hours 45 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 23 hours 45 minutes post-dose Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
60485|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 12 hours post-dose Day 1 and Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
60486|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 4 hours post-dose Day 1 and Week 26|Participants from full analysis set, all randomized participants who received study drug, with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from analysis.||Liters||Standard Error|Least Squares Mean
60487|NCT01202188|Secondary|"Percentage of Days With no Rescue Medication Use Over 26 Weeks"|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the full analysis set (all randomized participants who received at least one dose of study drug) with evaluable data (at least 40 days of diary data) available for analysis.||Percentage of days||Standard Error|Least Squares Mean
60512|NCT01201967|Secondary|Change in Health Status From Baseline to 24 Weeks|Health status measured by the Euro Quality of Life-5 Domain (EQ5D). The EQ5D is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
60488|NCT01202188|Secondary|Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs in the morning and evening were calculated and divided by the number of days with data to determine the mean daily number of daytime and nighttime puffs. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline (BL) ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.||Puffs||Standard Error|Least Squares Mean
60489|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 12, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis at Week 12 and Week 26.||Puffs per day||Standard Error|Least Squares Mean
60490|NCT01202188|Secondary|"Percentage of Days Able to Perform Usual Daily Activities Over 26 Weeks"|"Patients answered the question Did your respiratory symptoms stop you performing your usual activities today?-Not at all in their daily diary. The percentage of days is calculated by the number of days patient is able to perform daily activities/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of Days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect."|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.||Percentage of days||Standard Error|Least Squares Mean
60491|NCT01202188|Secondary|"Percentage of Days With No Daytime Symptoms Over 26 Weeks"|A day with no day time symptoms is defined from the diary data as any day where the patient recorded no coughing, no wheezing, no sputum production and no breathlessness during the previous 12 hours (approximately 8AM to 8PM). The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.||Percentage of days||Standard Error|Least Squares Mean
60492|NCT01202188|Secondary|"Percentage of Nights With No Night Time Awakenings Over 26 Weeks"|A day with no night time awakenings is defined from the diary data as any day where the patient did not wake up due to COPD symptoms. The percentage of nights is calculated by the number of days with no nighttime awakenings/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.||Percentage of nights||Standard Error|Least Squares Mean
60493|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status.|Baseline, Week 26|Participants from the Full Analysis Set, that included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Percentage of participants|||Number
60494|NCT01202188|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Score on a scale||Standard Error|Least Squares Mean
73801|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and 52 week after|||U/L||Standard Deviation|Mean
60495|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing) at Week 12 and Week 26. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. The BDI (baseline) was measured at Day 1. The TDI captures changes from baseline. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9.|Baseline, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.||Percentage of participants|||Number
60496|NCT01202188|Secondary|Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26|"A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.~A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators as covariates and included baseline smoking status, baseline inhaled corticosteroids and region as fixed effects with center nested within region as a random effect."|Baseline, Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Score on a scale||Standard Error|Least Squares Mean
60497|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Per-protocol Set, randomized participants who received at least one dose of study drug without major protocol deviations. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
60498|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
60499|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.||Puffs per day||Standard Error|Least Squares Mean
60500|NCT01202188|Secondary|St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 26|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 weeks|Participants from the Full Analysis Set,included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.||Score on a scale||Standard Error|Least Squares Mean
60513|NCT01201967|Secondary|Number of Rehospitalizations From Baseline to 24 Weeks|The number of rehospitalizations from baseline to 24 weeks was measured by contacting subjects' medical providers at 24 weeks and by asking subjects about rehospitalizations during each follow-up phone call.|24 weeks|||readmissions|||Number
60676|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 12||Baseline (Day 1) and Week 12|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 12||log10 Copies/mL||Full Range|Median
60501|NCT01202188|Secondary|Transitional Dyspnea Index (TDI) Focal Score at Week 26|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.||Score on a scale||Standard Error|Least Squares Mean
60502|NCT01202188|Primary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.||Liters||Standard Error|Least Squares Mean
60503|NCT01202162|Secondary|Quality of Recovery 40|Survey completion at 24 hours post surgery of the Quality of Recovery 40 questionnaire.This questionnaire asks 40 questions in 5 categories of recovery. The scores are combined from each group and are used as a composite score. The scores range from a low of 40 to a high of 200. A score of 40 would indicate a poor quality of recovery where as a score of 200 would be a good quality of recovery at 24 hours postoperative.|1 day|In the Desflurane group 35 completed the survey 24 hours postoperative where as 33 in the Sevoflurane completed the survey during the postoperative period.||score (between 40 low-200 high)||Inter-Quartile Range|Median
60504|NCT01202162|Secondary|Number of Participants Who Coughed||Perioperative|||participants|||Number
60505|NCT01202162|Primary|Time to Awakening||Time inhalational agent is turned off to time of patient awakening|||Elapsed time in minutes||Inter-Quartile Range|Median
60506|NCT01202110|Primary|Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.|The primary outcome is to determine the safety of early propranolol treatment after TBI by recording the number of episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) refractive to treatment.|24 months|Terminated prior to enrolling|||||
60507|NCT01202071|Secondary|Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])|"Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).~Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)|||ng*h/mL||Standard Deviation|Mean
60508|NCT01202071|Secondary|Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)|"Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).~Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV|||ng/mL||Standard Deviation|Mean
60509|NCT01202071|Primary|Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration|The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.|Day 5 of administration during Period I-IV|||Percentage of Time in a 24 Hour Period||Standard Deviation|Mean
60510|NCT01201967|Secondary|Change in Physical Health-related Quality of Life From Baseline to 24 Weeks|Physical health-related quality of life is measured with the Short Form-12 Physical Component Score (SF-12 PCS). The SF-12 PCS a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.|Baseline, 24 weeks|||units on a scale||95% Confidence Interval|Mean
60511|NCT01201967|Secondary|Change in Physical Function From Baseline to 24 Weeks|Physical function is measured with the Duke Activity Status Index (DASI). The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
60525|NCT01201811|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
60514|NCT01201967|Secondary|Change in Adherence to Health Behaviors From Baseline to 24 Weeks|Adherence to health behaviors is measured with the Medical Outcome Study Specific Adherence Scale (MOS-SAS). The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
60515|NCT01201967|Secondary|Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment|"Adequate treatment was defined as:~(1) Prescription of a standard dose of an established first-line treatment for depression, generalized anxiety disorder, or panic disorder, and/or (2) referral to evidence-based psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborative Care arm of the study).~Patients already engaged in #1 and/or #2 at the time of enrollment had a different process. Subjects must have been engaged in at least 4 weeks of treatment prior to enrollment while still meeting criteria for the disorder. For this population, adequate treatment was defined as:~(1) Prescription dose increase/augmentation/switch, and/or (2) referral to psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborate Care arm).~Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects."|5 days after enrollment|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||participants|||Number
60516|NCT01201967|Secondary|Change in Anxiety Symptoms From Baseline to 24 Weeks|Anxiety symptoms measured with the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
60517|NCT01201967|Secondary|Change in Depression Symptoms From Baseline to 24 Weeks|Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
60518|NCT01201967|Primary|Change in Mental Health-related Quality of Life From Baseline to 24 Weeks|Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.||units on a scale||95% Confidence Interval|Mean
60519|NCT01201915|Secondary|Time to Complete Clinical Clearance|Time to complete clinical clearance was defined as the time from the first treatment with vismodegib until complete clinical clearance as determined by the investigator.|Baseline to the end of the study (up to 12 weeks for Cohort 1; up to 36 weeks for Cohort 2, up to 20 weeks for Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug. Only participants who achieved complete clinical clearance were included in the analysis.||Days||95% Confidence Interval|Median
60520|NCT01201915|Primary|Percentage of Participants With Complete Histologic Clearance|Complete histologic clearance was defined as the absence of histological evidence of basal cell carcinoma at the target tumor site. Histological examination was performed by an independent pathologist on specimens collected within 2 weeks of the end of treatment period, ie, at 12 weeks after Baseline in Cohort 1, at 36 weeks after Baseline in Cohort 2, and at 20 weeks after Baseline in Cohort 3.|Baseline to Week 12 (Cohort 1), Baseline to Week 36 (Cohort 2), Baseline to Week 20 (Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
60521|NCT01201811|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||Liters||Geometric Coefficient of Variation|Geometric Mean
60522|NCT01201811|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|Timeframe: Days 5 and 6 at predose and Day 7 (pre-dose) at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||L/hr||Geometric Coefficient of Variation|Geometric Mean
60523|NCT01201811|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|Timeframe: Day 7 pre-dose at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||hours||Geometric Coefficient of Variation|Geometric Mean
60524|NCT01201811|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||hours||Geometric Coefficient of Variation|Geometric Mean
68942|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4|Change in 24-hour urinary calcium excretion from Baseline to week 4|Baseline and week 4|||mmol/24hr||Standard Deviation|Mean
60526|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
60527|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ was not reported.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
60528|NCT01201811|Secondary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Treatment Emergent AEs (TEAE) were defined as AEs with an onset date on or after the first dose of study drug and within 28 days after the date of the last dose. In addition, any AE that occurred beyond this timeframe and that was assessed by the investigator as possibly related to study drug was considered a TEAE."|From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study drug 244 days)|Safety Population included enrolled participants who received at least one dose of investigational product and had at least one postdose assessment||participants|||Number
60529|NCT01201811|Secondary|Number of Infections (Post-baseline Average) Requiring Intravenous Antibiotics, Anti-fungals, or Antivirals Per 28 Days|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle. For each participant the overall post-baseline average was calculated as the average of # of infections requiring IV antibiotics or IV antiviral per 28 days per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.||Infections per cycle||Standard Deviation|Mean
60530|NCT01201811|Secondary|Number of Platelet Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of platelet transfusions per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.||Transfusions||Standard Deviation|Mean
60531|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered platelet transfusion independent at baseline if the participant had no platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) participants who were transfusion independent||percentage of particpants||95% Confidence Interval|Number
60532|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered platelet transfusion dependent at baseline if the participant had one or more platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population who were transfusion dependent||percentage of participants||95% Confidence Interval|Number
60533|NCT01201811|Secondary|Number of Red Blood Cell (RBC) Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study were standardized per 28 days and summarized by cycle for RBCs. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of RBC transfusions per cycle.|Up to week 24;The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|ITT Population- The intent-to-treat (ITT) population was defined as all enrolled participants.||Transfusions||Standard Deviation|Mean
60677|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 8||Baseline (Day 1) and Week 8|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 8||log10 Copies/mL||Full Range|Median
60534|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered RBC transfusion-independent at baseline if the participant had no RBC transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no RBC transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The Intent to Treat (ITT) participants who were transfusion independent||percentage of participants||95% Confidence Interval|Number
60535|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered transfusion dependent at baseline if the participant had one or more Red Blood Cell transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no transfusions during any 56 consecutive days or more (e.g., Day 1 through 56, Day 2 through 57, etc). Otherwise, they were considered transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit|The intent-to-treat (ITT) participants who were transfusion dependent||percentage of participants||95% Confidence Interval|Number
60536|NCT01201811|Primary|Percentage of Participants Showing Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Sponsor|"Hematologic improvements (HI) have 4 categories:~Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor- 10-20g/L increase or ≥50% decrease in transfusion requirements.~Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor-≥50% increase.~Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor-≥100% increase and absolute increase of <0.5x10^9/L~Progression or relapse after HI~Overall hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor’s determination was derived using clinically relevant data.~Denominator for progression/relapse after HI included participants who had achieved HI."|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants||percentage of participants||95% Confidence Interval|Number
60537|NCT01201811|Primary|Percentage of Participants With a Hematologic Response Using International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Investigator|"Hematologic Response according to the 2000 International Working Group (IWG) response criteria for MDS was based on the Investigators determination and defined as:~Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia~Partial Response (PR): same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment~Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months.~Failure: death during treatment or disease progression~Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence~Disease Progression: change in blast levels~Disease Transformation to AML"|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants||percentage of participants||95% Confidence Interval|Number
60538|NCT01201798|Secondary|Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits|The following signs were each graded on a 0 – 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
60539|NCT01201798|Secondary|Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points|The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
60540|NCT01201798|Secondary|Proportion of Subjects Who Discontinued Due to Lack of Efficacy|Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects.|Time to Event|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications.||Percentage of subjects|||Number
60678|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 4||Baseline (Day 1) and Week 4|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 4||log10 Copies/mL||Full Range|Median
60541|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade ≤1|As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
60542|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
60543|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
60544|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Percentage of subjects|||Number
60545|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points|Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
60546|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
60547|NCT01201798|Primary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 14|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.||Units on a scale||Standard Deviation|Mean
60548|NCT01201785|Primary|Collagen Induced Aggregation|Collagen induced aggregation using light transmittance aggregometry|after 1 -week of treatment|A 20% SD for the difference between collagen-induced platelet aggregation in patients on aspirin 81 mg od versus 81 mg bid was assumed, and based on a power of 80% and a significance level of 0.05. Based on these values, we determined that a sample population of 20 patients would be needed.||percentage of platelet aggregation||Standard Deviation|Mean
60549|NCT01201772|Primary|PRI Levels at 4 Hours||4 hours after treatment|A total of 65 patients were randomized. One patient assigned to the 10mg prasugrel group was withdrawn after randomization due to anemia identified after baseline blood sampling. Finally, 64 patients [10 mg (n=22), 30 mg (n=21) and 60 mg (n=21)] completed all time periods of the study.||percentage of platelet reactivity||Standard Error|Mean
60550|NCT01201759|Secondary|Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5|"The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting).~For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject’s factors."|Study visit at min -30 (fasting)|All enrolled participants who completed the study.||mg/dL||Standard Deviation|Mean
60551|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min.~For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.||mg*min/dL||Standard Deviation|Mean
60552|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min.~For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All participants who completed treatment.||mg*min/dL||Standard Deviation|Mean
60553|NCT01201759|Primary|Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min.~For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.||mg*min/dL||Standard Deviation|Mean
60554|NCT01201486|Primary|Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy|The number of *fetuses with* heart defects detected by color Doppler in the second trimester was compared to the number of *fetuses with* major heart defects detected at birth.|2nd trimester|||fetuses|||Number
60555|NCT01201343|Secondary|Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24|Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)|Baseline, Months 1, 2, 3, 6, 12, and 24|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
60556|NCT01201343|Secondary|Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
60557|NCT01201343|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
60558|NCT01201343|Secondary|Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
60559|NCT01201343|Secondary|Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
60560|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.||units on a scale||Standard Deviation|Mean
60561|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 18|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.||units on a scale||Standard Deviation|Mean
60562|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 12|Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.||units on a scale||Standard Deviation|Mean
60563|NCT01201317|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.|Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.|Baseline (Day 1) to Day 29 (Visit 7)|Modified Intention- to- treat set (ITT) including only patients with adequate baseline and Day 29 data||Scores on a scale||Standard Deviation|Mean
60564|NCT01201317|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)||Participants|||Number
60565|NCT01201317|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥30% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)||Participants|||Number
60566|NCT01201317|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)||Scores on a scale||Standard Deviation|Mean
60567|NCT01201317|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)||Scores on a scale||Standard Deviation|Mean
60568|NCT01201265|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.||mmHg||Standard Deviation|Mean
60569|NCT01201265|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.||millimetre of mercury (mmHg)||Standard Deviation|Mean
60570|NCT01201265|Secondary|Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)|The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms.|Baseline, cycle 6|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. Here, n signifies the number of participants evaluable at specified time points.||units on a scale||Standard Deviation|Mean
60571|NCT01201265|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 28 days after termination of study treatment (approximately 1569 days)|Safety population included all participants who received at least one dose of study treatment.||participants|||Number
60572|NCT01201265|Secondary|Overall Survival (OS)|Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||days||95% Confidence Interval|Median
64135|NCT01169103|Primary|Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months|Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk|Baseline and 6 months|||ng/mL||Standard Deviation|Mean
60573|NCT01201265|Secondary|Time to Progression (TTP)|Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression.|From the date of registration until the disease progression (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||days||95% Confidence Interval|Median
60574|NCT01201265|Secondary|Percentage of Participants Achieving a Clinical Benefit Response (CBR)|Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||percentage of participants||95% Confidence Interval|Number
60575|NCT01201265|Secondary|Percentage of Participants Achieving an Overall Response|The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.||percentage of participants||95% Confidence Interval|Number
60576|NCT01201265|Primary|Progression-free Survival (PFS)|Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From the date of registration until the disease progression or death (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment||days||95% Confidence Interval|Median
60577|NCT01200992|Secondary|Comparison of Safety of EN3348 With Mitomycin C.|Safety endpoints will include all adverse events including serious adverse events, vital signs, physical exams and laboratory test results.|Throughout study||08/2019||||
60578|NCT01200992|Primary|Comparison of Event-free Survival of Intravesical EN3348 With Mitomycin C.|Primary efficacy endpoint will be event-free survival - the interval from randomization to an event. An event is defined as tumor recurrence, tumor progression to muscle invasive bladder cancer or death, whichever occurs first. Tumor recurrence or progression must be documented by bladder biopsy.|1 year|The study was discontinued early. The number of subjects randomized at time of closure represented 18.7% of the planned enrollment of 450 subjects. Thus, the planned analysis as stated in the protocol was not performed. Only 2 subjects (5.1%) in the EN3348 arm and 4 subjects (8.9%) in the mitomycin C arm completed all planned doses.|||||
60579|NCT01200875|Primary|Blood Growth Factor Concentrations||5 days following PRP injection|||IGF-1 fold-change from baseline @ 24h||95% Confidence Interval|Mean
60580|NCT01200810|Secondary|Safety and Tolerability Assessed Using NCI CTCAE Version 4.0|Number of participants randomized to RO4929097 arm who experienced serious adverse events .|Up to 12 months|||participants|||Number
60581|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Observation Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. No subjects entered the observation phase.|||||
60582|NCT01200810|Secondary|Time to PSA Progression During the Observation Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. No subjects entered the observation phase.|||||
60583|NCT01200810|Secondary|Time to PSA Progression During the Combination Phase||Up to 12 months||||||
60584|NCT01200810|Secondary|Time to PSA Nadir During the Combination Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug.|||||
60585|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Combination Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.|||||
60586|NCT01200810|Secondary|Proportion of Patients Who Achieve Complete Response (by PSA) During the Combination Phase||Up to 12 months|Analysis could not be conducted as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.|||||
60587|NCT01200810|Primary|Time to PSA Progression|Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.|Up to 12 months|Analysis could not be conducted as the protocol was terminated early due to lack of study drug. Only three patients progressed during randomization phase.|||||
60622|NCT01200524|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28||Scores on a scale||Standard Deviation|Mean
60588|NCT01200797|Primary|Time to Progression (TTP)|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to date of progression (assessed up to 12 months)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.||days||95% Confidence Interval|Median
60589|NCT01200797|Primary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details).|On‐study date to date of death from any cause (assessed up to 12 months)|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||daya||95% Confidence Interval|Median
60590|NCT01200797|Primary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of (assessed up to 12 months)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
60591|NCT01200797|Primary|Number of Patients With Each Worst-grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death.|On‐study date to 30 days following final dose of study|Total number of patients reported with any toxicity. Not all participants may have an adverse event, thus not every patient on-treatment may be accounted for in worst-grade toxicities.||participants|||Number
60592|NCT01200797|Primary|Overall Response (OR)|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. Confirmation of CR or PR is required to deem either one the best overall response.|On‐treatment date to date of disease progression (assessed up to 12 months)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is nonevaluable for best overall response||participants|||Number
60593|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs)|Levels of HACA in serum were collected at Day of each cycle up to Cycle 8 and at follow-up visit. n = number of participants analyzed for the endpoint at the specified timepoint.|Baseline, Post-Baseline (Cycle 1 Day 1 [induction] up to follow-up) (a median of 27 months; up to data cutoff of 3 February 2014)|Safety Analysis Population.||percentage of participants|||Number
60594|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase|n = number of participants analyzed for the endpoint at the specified timepoint.|Stage I and II (maintenance): Day 1 of Cycle 9 to 20 (up to data cutoff of 3 February 2014)|ITT Population.||percentage of participants|||Number
60595|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase|n = number of participants analyzed for the endpoint at the specified timepoint. The data was presented up to data cutoff of 3 February 2014.|Stage I and II (induction): for rituximab IV - Day 1 of Cycle 1 to 8; for rituximab SC - Day 1 of Cycle 1 and Cycle 3 to 8, Day 0 of Cycle 2, thereafter at follow-up visits every 12 weeks after the last rituximab administration until 72 weeks|ITT Population.||percentage of participants|||Number
60596|NCT01200758|Secondary|Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration|n = number of participants analyzed for the endpoint at the specified timepoint.|12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (median treatment duration: 383.5 days for IV dose and 406 days for SC dose; up to data cutoff of 3 February 2014)|Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Participants were analyzed as treated.||µg/mL||Full Range|Median
60597|NCT01200758|Secondary|Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle|n (number) = participants analyzed in specified cycle for this endpoint. The data was provided up to data cutoff of 3 February 2014.|C-trough values are based upon samples scheduled before each maintenance Cycle 9 to 20 (maintenance Cycle 1 to 12). i.e. 'Cycle 8' and ‘Cycle 19’ are before the first and last maintenance administration at ‘Cycle 9’ and 'Cycle 20’, respectively.|ITT Population.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
60598|NCT01200758|Secondary|Stage I and II (Pooled): Trough Serum Concentrations (Ctrough) of Rituximab at Each Induction Treatment Cycle|n = number of participants analyzed for the endpoint at the specified timepoint. The data was provided up to data cutoff of 3 February 2014.|C-trough values are based upon samples scheduled 21 days after study drug administration (before the next scheduled cycle), except for cycle 8 which were scheduled 28 days after drug administration.|ITT Population.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
60599|NCT01200758|Secondary|Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab at Cycle 7|Number of participants with evaluable PK data contributing to summary statistics were included.|Stage I (Induction): pre-dose and 24 hours post-dose on Cycle 7 (Days 1, 3, 7, and 15), pre-dose on Cycle 8 Day 1; additionally within 15 minutes after end of infusion on Cycle 7 Day 1 (up to cutoff date of 11 April 2012)|Stage 1 PK Evaluable Population.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
60600|NCT01200758|Secondary|Stage 1: Observed Area Under the Serum Concentration-Time Curve (AUC) of IV and SC Rituximab at Week 7|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Number of participants with evaluable PK data contributing to summary statistics were included.|Stage I (Induction): pre-dose and 24 hours post-dose on Cycle 7 (Days 1, 3, 7, and 15), pre-dose on Cycle 8 Day 1; additionally within 15 minutes after end of infusion on Cycle 7 Day 1 for rituximab IV (up to data cutoff of 11 April 2012)|PK evaluable population.||µg.day/mL||Geometric Coefficient of Variation|Geometric Mean
60601|NCT01200758|Secondary|Stage I and II (Pooled): Median Time to Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival (i.e., at the last time known to be alive).|Baseline until documented disease progression/relapse or death (up to study completion)||11/2018||||
60602|NCT01200758|Secondary|Stage I and II (Pooled): Event-Free Survival||Baseline until documented disease progression/relapse or death (up to study completion)||11/2018||||
60603|NCT01200758|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was defined as progression in the participant's clinical symptoms according to the International Working Group response criteria for NHL.|Baseline, Day 1 of all cycles (Cycles 1-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 3 February 2014)|ITT Population.||percentage of participants|||Number
60604|NCT01200758|Secondary|Stage 1 and II (Pooled): Progression-Free Survival (PFS)|PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression was defined as progression in the participant's clinical symptoms according to the International Working Group response criteria for NHL. PFS analysis was performed using Kaplan – Meier curves.|Baseline, Day 1 of all cycles (Cycles 1-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 3 February 2014)|ITT Population.||days||95% Confidence Interval|Median
60605|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment|Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper. Number of subjects analysed = participants evaluable for the analysis.|Stage I and II: up to 78 days after last maintenance dose (last maintenance dose: maintenance Cycle 12/Study Cycle 20 [30 months])|ITT population; only participants who completed all 12 cycles of rituximab maintenance or who had withdrawn during the maintenance period were included in the analysis.||percentage of participants||95% Confidence Interval|Number
60606|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. Number of subjects analysed = participants evaluable for the analysis.|Stage I and Stage II: up to 78 days after last maintenance dose (last maintenance dose: maintenance Cycle 12/Study Cycle 20 [30 months])|ITT population; only participants who completed all 12 cycles of rituximab maintenance or who had withdrawn during the maintenance period were included in the analysis.||percentage of participants||95% Confidence Interval|Number
60607|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cycle 8 (24 weeks)|ITT Population.||percentage of participants||95% Confidence Interval|Number
60608|NCT01200758|Secondary|Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage II: up to end of induction treatment Cycle 8 (24 weeks)|ITT Population.||percentage of participants||95% Confidence Interval|Number
60623|NCT01200524|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28||Scores on a scale||Standard Deviation|Mean
60609|NCT01200758|Secondary|Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment|Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses.|Stage I: up to end of induction treatment Cycle 8 (24 weeks)|ITT Population.||percentage of participants||95% Confidence Interval|Number
60610|NCT01200758|Primary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment|Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cycle 8 (24 weeks)|ITT Population.||percentage of participants||95% Confidence Interval|Number
60611|NCT01200758|Primary|Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment|Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for Non-Hodgkin lymphoma (NHL). CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage II: up to end of induction treatment Cycle 8 (24 weeks)|ITT Population.||percentage of participants||95% Confidence Interval|Number
60612|NCT01200758|Secondary|Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment|Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage I: up to end of induction treatment Cycle 8 (24 weeks)|Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not.||percentage of participants||95% Confidence Interval|Number
60613|NCT01200758|Primary|Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab|Number of participants = participants analyzed for this endpoint.|Stage I: Cycle 7 Day 21 (within 2 hours pre-dose on Cycle 8) of induction treatment|Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received.||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
60614|NCT01200602|Secondary|Toxicity Profile|Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
60615|NCT01200602|Secondary|Weight Maintenance Over Time||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
60616|NCT01200602|Secondary|Caloric Intake||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
60617|NCT01200602|Secondary|BMI Trends||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
60618|NCT01200602|Primary|Proportion of Patients Who Maintain Weight or Experience Weight Gain|A patient will be defined as “success” if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
60619|NCT01200524|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.|LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.|Baseline (Day 1) to Day 29 (Visit 7)|mITT analysis set including only those that had adequate NPSI data at baseline and Day 29||Scores on a scale||Standard Deviation|Mean
60620|NCT01200524|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set||Participants|||Number
60621|NCT01200524|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)*100. Responder=NRS Average Pain score reduction ≥30% (yes/no)|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set||Participants|||Number
73802|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase|Change from baseline|Baseline and 52 week after|||U/L||Standard Deviation|Mean
60624|NCT01200498|Primary|Participants With an Objective Response|Objective response defined as Complete, Partial response, and Clinical Improvement based on International Working Group (IWG) Criteria: Complete remission (CR): Absence transfusion & growth factor support AND Complete resolution disease-related symptoms/signs; Peripheral blood count remission; Normal leukocyte differential; Bone marrow histological remission. Partial remission (PR): All CR except bone marrow histological remission. Clinical improvement (CI): No CR/PR, disease progression with one: ≥2 g/dL increase hemoglobin level or transfusion independent; Either ≥50% reduction in palpable splenomegaly of spleen ≥10 cm baseline or spleen palpable at >5 cm baseline becomes not palpable; ≥100% increase in platelet count & absolute platelet count ≥50,000 x 10^9/L; or ≥100% increase in absolute neutrophil count (ANC) & ANC ≥0.5 x 10^9/L. Progressive disease: Progressive splenomegaly or Leukemic transformation confirmed by bone marrow blast of ≥20%; or Increase peripheral blood blast|Baseline to 3 Cycles (84 days)|||Participants|||Number
60625|NCT01200433|Secondary|Number of Apneic Episodes.|The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.|during DBS surgery|||number of episodes||Inter-Quartile Range|Median
60626|NCT01200433|Secondary|Number of Hypertensive Episodes|The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.|During DBS surgery|||number of episodes||Standard Deviation|Mean
60627|NCT01200433|Secondary|Cerebral Perfusion Pressure||at the first peak during DBS surgery|||mmHg||Inter-Quartile Range|Median
60628|NCT01200433|Secondary|Pulsatility Index|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.|at the first peak during DBS surgery|||units on a scale||Inter-Quartile Range|Median
60629|NCT01200433|Secondary|Alertness/Sedation|Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)|at the first peak during DBS surgery|||units on a scale||Inter-Quartile Range|Median
60630|NCT01200433|Secondary|Cerebral Blood Flow|The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.|after procedure, in post anesthesia care unit (PACU)|The cerebral flow at PACU was not planned as a primary outcome. The primary outcome was cerebral flow at the first peak of study drug. The data was collect for information purpose only. No test was done for cerebral blood flow at PACU.||cm/sec||Standard Deviation|Mean
60631|NCT01200433|Primary|Brain Oxygen|Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.|during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods|||% oxygenation||Inter-Quartile Range|Median
60632|NCT01200433|Primary|Cerebral Blood Flow|Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.|For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.|||cm/sec||Inter-Quartile Range|Median
60633|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
60634|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
60635|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
60636|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.||percentage of participants|||Number
60668|NCT01199939|Secondary|Time to Reach First Confirmed Virologic Response|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus – type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications||Days||Standard Error|Mean
61207|NCT01195090|Secondary|Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||HOMA-IR score||Standard Error|Least Squares Mean
60637|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
60638|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
60639|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
60640|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
60641|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.||EU/mL||95% Confidence Interval|Geometric Mean
60642|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.||IU/mL||95% Confidence Interval|Geometric Mean
60643|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all expected doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
60644|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
60645|NCT01200368|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.||percentage of participants||95% Confidence Interval|Number
60669|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 48||Baseline (Day 1) and Week 48|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 48||log10 Copies/mL||Full Range|Median
60670|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 42||Baseline (Day 1) and Week 42|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 42||log10 Copies/mL||Full Range|Median
60671|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 36||Baseline (Day 1) and Week 36|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 36||log10 Copies/mL||Full Range|Median
60646|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
60647|NCT01200368|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.||percentage of participants||95% Confidence Interval|Number
60648|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series|Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
60649|NCT01200368|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
60650|NCT01200368|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
60651|NCT01200368|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
60652|NCT01200342|Primary|Number of Participants With Response|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions.||Participants|||Number
99753|NCT00816036|Secondary|Referrals to Quitline||Assessed within 72 hours of hospital discharge|||participants|||Number
60653|NCT01200342|Primary|Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions. Due to inadequate enrollment of study participants, no statistical analyses were able to be performed.||Percentage of Participants|||Number
60654|NCT01200160|Secondary|Overall Safety and Tolerability of Niaspan|Evaluate overall safety of Niaspan through evaluation of adverse events|every 4 weeks for 24 weeks||||||
60655|NCT01200160|Secondary|Frequency of Flushing Events|evaluate occurrence of such events over time|every 4 weeks for 24 weeks||||||
60656|NCT01200160|Secondary|Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values|Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score|every 4 to 8 weeks for 24 weeks||||||
60657|NCT01200160|Primary|Effectiveness of Niaspan|"Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels.~Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression:~percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))*100 Then percent change is calculated at 24 weeks regarding baseline for different variables."|24 weeks regarding baseline visit (visit1)|||mg/dL||Standard Deviation|Mean
60658|NCT01200069|Secondary|Incidence of Headache & Severity Headache After ECT Treatment #3|Subject self reported numerical rating of incidence and severity of post ECT headache after treatment #3, 0=no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9 very serious pain, 10=unbearable pain.|1 hour after treatment, 6 hours, 24 hours and 48 hours|||units on a scale||Full Range|Mean
60659|NCT01200069|Secondary|Incidence and Severity of Headache After ECT Treatment 2|Subject self reported numerical rating of incidence and severity of post ECT headache 0=no pain, 2-4=moderate pain, 5-7= distressing severe pain, 8-9= very severe pain, 10=unbearable pain.|1 hour, 6 hour, 24 hour and 48 hours|||units on a scale||Full Range|Mean
60660|NCT01200069|Secondary|Pre-treatment With IV Ibuprofen Will Attenuate and Decrease the Severity of Post ECT Headache at Treatment Day 1|Subject self reported numerical rating of incidence and severity of Post ECT pain score for headache at 1, 6, 24 and 48 hours post procedure. Pain Rating 0= no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9=intense very severe pain, 10=unbearable pain|1 hour, 6 hours, 24 hours & 48 hours following procedure|||units on a scale||Full Range|Mean
60661|NCT01200069|Primary|Myalgia Reported After Treatment #3|Subject self reported severity of myalgia based on a self reported assessment utilizing numeric rating scale 0=no myalgia, 1-3=mild myalgia (annoying, little interference with ADL);4-6=moderate (interferes significantly with ADL); 7-10 severe myalgia(unable to perform every day activities)|1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment|||units on a scale||Full Range|Median
60662|NCT01200069|Primary|Myalgia Reported on Treatment Day 2|Subject self reported numerical rating of incidence and severity of post ECT Myalgia after treatment day 2 0=no pain, 1-3=mild pain (annoying, little interference with ADL), 4-6= moderate,( interferes significantly with ADL) 7-10 severe pain (unable to perform everyday activities)|1 hour, 6 hours, 24 hours & 48 hours following procedure|||units on a scale||Full Range|Median
60663|NCT01200069|Primary|Pre Treatment With IV Ibuprofen Will Attenuate & Decrease the Severity of Post ECT Myalgia|subject self reporting rating scale for severity of myalgias utilizing numeric rating scale 0= no pain, 1-3= mild pain, annoyance with little interference with Activities of Daily Living (ADL), 4-6= moderate (interferes significantly with ADL, 7-10 = severe pain unable to perform ADL|Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours|subjects report at one hour following treatment||units on a scale||Full Range|Median
60664|NCT01199965|Primary|AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg*h/ml||Standard Deviation|Geometric Mean
60665|NCT01199965|Primary|Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Geometric Mean
60666|NCT01199939|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) and Cluster of Differentiation 8 (CD8+) Cell Counts at Week 48||Baseline (Day 1) and Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications||cells/uL||Standard Deviation|Mean
60667|NCT01199939|Secondary|Number of Participants With Virologic Failure|Virologic Failure is defined as participant who is a rebounder or a non-responder. Rebounder participant is defined as a participant who is still in the study at Week 12 and first achieves 2 consecutive virologic responses (<50 copies/mL) followed by 2 consecutive non-responses or a discontinued participant (any reason) for which the last observed time point shows a non-response. Non responder participant is defined as a participant who is still in the study at Week 12 and never achieves 2 consecutive responses.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications||Participants|||Number
73803|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and 52 week after|||U/L||Standard Deviation|Mean
60679|NCT01199939|Primary|Number of Participants With Confirmed Virologic Response (CVR) at Week 48|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus – type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Week 48|Intent-To-Treat Non-Virologic failure (VF) censored: Participants who took at least one dose of any of the study medications and did not withdraw for reasons other than VF or experienced VF prior to discontinuation. Participants with evaluable data at Week 48||Participants|||Number
60680|NCT01199926|Primary|Inflammation|The primary endpoint is the change in C reactive protein after the three month intervention|three months|||mg/L||Standard Deviation|Mean
60681|NCT01199926|Primary|Glucose Tolerance|The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.||mmol/L/120 min||Standard Deviation|Mean
60682|NCT01199926|Primary|Muscle Function|The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.||kilograms||Standard Deviation|Mean
60683|NCT01199861|Secondary|Number of Participants With Adverse Events (AEs)|"Relationship to study drug was determined by the investigator (suspected/not suspected).~A serious AE is defined as an event which fulfills one of the following criteria:~is fatal or life-threatening;~results in persistent or significant disability/incapacity;~constitutes a congenital anomaly/birth defect;~requires inpatient hospitalization or prolongation of existing hospitalization;~is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above."|From first dose of study drug until 45 days after the last dose of study drug (130 days).|Safety set - all patients who received at least 1 dose of study drug.||participants|||Number
60684|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).|Full analysis set for whom data were available.||ratio|||Number
60685|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).|Full analysis set for whom data were available.||ratio|||Number
60686|NCT01199861|Secondary|Immune Response 6 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:~Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.~Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)|Full analysis set for whom data were available.||percentage of participants|||Number
60687|NCT01199861|Secondary|Immune Response 3 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:~Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.~Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)|Full analysis set for whom data were available.||percentage of participants|||Number
60688|NCT01199861|Secondary|Immune Response 6 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:~Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.~Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).|Full analysis set for whom data were available.||percentage of participants|||Number
60689|NCT01199861|Primary|Immune Response 3 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:~Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.~Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)|The full analysis set which includes all patients who were randomized and received at least 1 dose of study drug, and for whom data were available.||percentage of participants|||Number
60690|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications|Concomitant medications are defined as drugs used during the administration of Relenza.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60716|NCT01199471|Secondary|Time to Intubation of Patients|The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.|Up to 10 minutes|All available data were included in the analysis.||minutes||Standard Deviation|Mean
60691|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60692|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories|Participants with only hypertension were excluded from the cardiocirculatory disease category. Participants in high-risk categories are at risk for the aggravation of both infection and symptoms.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60693|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Risk Factors for Influenza or Having no Risk Factors|Risk factors are defined as pregnancy; infancy; being elderly; and having chronic respiratory disease, cardiocirculatory disease, and/or diabetes.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60694|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications|A complication is defined as asthma.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60695|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza|The dose given for treatment of influenza is 10 mg twice daily for 5days. Prophylaxis is defined as a measure taken for the prevention of a disease or condition. The prophylactic dose of Relenza is 10 mg once daily for 10 days.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60696|NCT01199744|Secondary|Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60697|NCT01199744|Secondary|Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60698|NCT01199744|Secondary|Number of Participants With Any Serious Adverse Drug Reaction (ADR)|"A serious ADR is defined as a serious adverse drug event (ADE) that a physician has determined to be related to the use of Relenza. Serious ADE: death caused by an ADR; an event that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in severe symptoms requiring treatment so that symptoms do not lead to previously mentioned outcomes, and a congenital anomaly/birth defect. For a complete list of all serious ADRs recorded during the study, see Serious Adverse Events section."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60699|NCT01199744|Primary|Number of Participants With Any Adverse Drug Reaction|"An adverse drug reaction is defined as a drug adverse event that a physician has determined to be related to the use of Relenza. A drug adverse event is defined as any unfavorable or unintended sign (including laboratory test abnormalities), symptom, or disease that occurs when a drug is administered, regardless of the relationship to the drug. For a complete list of all adverse drug reactions recorded during the study, see the section entitled Other (Non-serious) Adverse Events."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza||participants|||Number
60700|NCT01199705|Secondary|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.~Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 36 weeks|The SDS comprised all subjects treated with the study drug.||AEs per infusion|Participants||Number
60701|NCT01199705|Secondary|Rate of All Adverse Events by Relatedness and Seriousness|The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 36 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.||AEs per infusion|Participants||Number
60702|NCT01199705|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks|||Days||Full Range|Median
60703|NCT01199705|Secondary|Number of Days of Hospitalization Due to Infections by Study Period|Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks|||Days||Full Range|Median
60704|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)~SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.||SBIs per subject year|Participants||Number
60705|NCT01199705|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks|||Days||Full Range|Median
60706|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)~SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.||SBIs per subject year|Participants||Number
60707|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)~SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.||Infections per subject year|Participants||Number
60708|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)~SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.||Infections per subject year|Participants||Number
60709|NCT01199705|Secondary|Number of Infection Episodes (Serious and Non-serious) by Study Period|"Number of infection episodes (serious and non-serious) presented by study period:~IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).~SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.~SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy."|Up to 36 weeks|||Number of infection episodes|||Number
60710|NCT01199705|Primary|IgG Trough Level|Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.|During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.||Ratio of Geometric Means||90% Confidence Interval|Number
60711|NCT01199601|Secondary|Completion of 9 Month Measles-mumps-rubella Vaccination on Time.|Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months|||participants|||Number
60712|NCT01199601|Secondary|Correct Breastfeeding Practices to 1 Year|Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months|||participants|||Number
60713|NCT01199601|Primary|Utilization of Postpartum Contraception|Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.|12 months|Participants included in analysis were those completing the 6 and 12 month follow-up visits.||participants|||Number
60714|NCT01199471|Secondary|Time to Extubation of Patients|The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.|Every minute after cessation of anesthesia until the patient was extubated|All available data were included in the analysis.||minutes||Standard Deviation|Mean
60715|NCT01199471|Secondary|Time to Eye Opening of Patients|Time to eye opening of patients was measured by the time from cessation of anesthesia administration to opening of the patients' eyes. After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process was repeated about every minute until the patients opened their eyes.|Every minute after cessation of anesthesia until the patient opened his/her eyes|All available data were included in the analysis.||minutes||Standard Deviation|Mean
60717|NCT01199471|Secondary|Time to Loss of Consciousness of Patients Administered Anesthesia|The time to loss of consciousness was measured from commencement of administration of anesthesia to the patient's loss of consciousness (no response to command).|Up to 10 minutes|All available data were included in the analysis.||minutes||Standard Deviation|Mean
60718|NCT01199471|Primary|Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
60719|NCT01199471|Primary|Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|400 participating anesthesiologists evaluated their satisfaction with anesthesia (sevoflurane) administered to patients during surgery. All available data for 3,993 patients are included and summarized.||units on a scale||Standard Deviation|Mean
60720|NCT01199237|Secondary|Time From Anesthetic Discontinuation to First Ability to Swallow|At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command.|up to 60 minutes after T1|||Seconds||Full Range|Mean
60721|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|60 minutes after T1|Only patients able to respond at time of assessment||units on a scale||Full Range|Mean
60722|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|30 minutes after T1|Only participants able to respond at time of assessment||units on a scale||Full Range|Mean
60723|NCT01199237|Secondary|Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)|"At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands open your eyes and squeeze my hand were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1."|Up to 1 hour post-operative|||seconds||Full Range|Mean
60724|NCT01199237|Primary|Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.|The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag.|At 2 minutes after response to command (T1).|Only participants judged by the clinician as able to take the test (n=57)||participants|||Number
60725|NCT01199042|Secondary|Average Therapy Pressure Values|"To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time.~This analysis compares the average pressure support of the first week compared to the average pressure support to the final week."|3 months|26 participants completed the 3-month home follow-up.||cm/H2O||Standard Deviation|Mean
60726|NCT01199042|Secondary|Breathing Event Indexes|"To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy.~Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment."|from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment|26 participants completed the 3-month home follow-up.||Apnea-Hypopnea events per hour||Standard Deviation|Mean
60727|NCT01199042|Secondary|Epworth Sleepiness Scale|"To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24.~Interpretation:~Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention.~Score 16-24: Excessive sleepiness and patient should consider seeking medical attention~A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness."|3 months|26 participants completed the 3-month home follow-up.||units on a scale||Standard Deviation|Mean
60728|NCT01199042|Primary|Apnea/Hypopnea Index (AHI)|To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.|During a single night of polysomnography lasting up to 8 hours.|||Apnea-Hypopnea events per hour||Standard Deviation|Mean
60729|NCT01198977|Other Pre-specified|Physical Activity (Behavioral Target)|First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.||units on a scale||Standard Error|Mean
60742|NCT01198769|Secondary|Serum Anti-rotavirus IgA Antibody Concentrations.|Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.||U/mL||95% Confidence Interval|Geometric Mean
60730|NCT01198977|Secondary|Depression|"Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).~Total Score for 9 items = 27."|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.||units on a scale||Standard Error|Mean
60731|NCT01198977|Primary|Fatigue|Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.||units on a scale||Standard Error|Mean
60732|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Function|"left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|||centimeters/second||Standard Deviation|Mean
60733|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)|"Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined||percentage of blood pumped out||Standard Deviation|Mean
60734|NCT01198873|Secondary|Changes From Baseline in Left Atrial Dimension|"Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined||centimeters||Standard Deviation|Mean
60735|NCT01198873|Secondary|Changes From Baseline in Left Atrial Function|"left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined||mililiters||Standard Deviation|Mean
60736|NCT01198873|Primary|Change From Baseline in Left Atrial Volume Index (LAVi)|"Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|"The analysis included all randomized and treated participants with at least one post-baseline echocardiographic assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).~The quality of the post-baseline echocardiography was inadequate for determining LAVi in one participant."||mililiters/m2||Standard Deviation|Mean
60737|NCT01198795|Primary|Patients With Any Treatment Emergent Adverse Events (TEAEs)|The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,|From Baseline (Week 0) to Week 26|||participants|||Number
60738|NCT01198769|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (from Dose 1 at Day 0 up to Month 4)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
60739|NCT01198769|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) follow-up period after vaccination|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
60740|NCT01198769|Secondary|Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.|"RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.~GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA)."|From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
60741|NCT01198769|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.|During the 8-day (Days 0-7) post-vaccination period|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
61209|NCT01195090|Secondary|Changes in Fasting Plasma Glucose|fasting serum sugar change from baseline to 24 weeks|24 weeks|An intent-to-treat (ITT) analysis with last observation carried forward was used to assess efficacy.||mg/dl||Standard Error|Least Squares Mean
60743|NCT01198769|Primary|Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.||Subjects|||Number
60744|NCT01198756|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
60745|NCT01198756|Secondary|Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
60746|NCT01198756|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination|"Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination."|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
60747|NCT01198756|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.|During the 28-day follow-up period (Day 0-27) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
60748|NCT01198756|Secondary|Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination|Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||Days||Inter-Quartile Range|Median
60749|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||Days||Inter-Quartile Range|Median
60750|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||Days||Inter-Quartile Range|Median
60751|NCT01198756|Secondary|Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||subjects|||Number
60769|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
104808|NCT00774163|Secondary|Number of Subjects With at Least One PCR Positive Stool Specimen||Average of 36 day follow up period|||participants|||Number
60752|NCT01198756|Secondary|Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||subjects|||Number
60753|NCT01198756|Secondary|Number of Days With Solicited Local Symptoms After Vaccination|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Inter-Quartile Range|Median
60754|NCT01198756|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.||subjects|||Number
60755|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||fold increase||95% Confidence Interval|Geometric Mean
60756|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60757|NCT01198756|Secondary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||subjects|||Number
60758|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
60770|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
61098|NCT01195779|Primary|Number of Subjects Reporting Fever of at Least Grade 2 or Higher|Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.|Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
60759|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||fold increase||95% Confidence Interval|Geometric Mean
60760|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60761|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
60762|NCT01198756|Primary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.||subjects|||Number
60763|NCT01198756|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
60764|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|Patient satisfaction will be assessed 6 weeks later at their post-op visit|||participants|||Number
60765|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|This will be assessed 3 day after the patient's C-section before they are discharged from the hospital|||participants|||Number
60766|NCT01198691|Primary|Post Operative Pain (3 Days Post-op)|Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year|||units on a scale||Standard Deviation|Mean
60767|NCT01198691|Primary|Post Operative Pain|Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year|||units on a scale||Standard Error|Mean
60768|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
61210|NCT01195090|Primary|Mean Change in Glycosylated Hemoglobin (A1C)|A1C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.||percentage of Hb||Standard Error|Least Squares Mean
60771|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
60772|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
60773|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
60774|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
60775|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
60776|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.||Units on a scale||Standard Deviation|Mean
60777|NCT01198574|Primary|Status of Cellular Iron Deficiency|Cellular Iron deficiency status is also measured by serum transferrin receptor|at week 0, week 6 and week12|Per Protocol analysis||mg/L||Standard Deviation|Geometric Mean
60778|NCT01198574|Primary|Status of Tissue Iron Store|Tissue iron store was measured by serum ferritin|at week 0, week 6 and week12|Per Protocol analysis||µg/L||Standard Deviation|Geometric Mean
60779|NCT01198574|Primary|Haemoglobin Level|Haemoglobin level (g/L) measured by cyanmethaemoglobin method|at week 0, week 6 and week12|Per Protocol||g/L||Standard Deviation|Mean
60780|NCT01198548|Secondary|PFS of Patients Receiving Study Treatment|"The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method.~3 Year Survival Rate"|Defined as the time from the start of the study treatment until the date of progression or death from any cause, whichever comes first, assessed up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
60781|NCT01198548|Secondary|OS of Patients Receiving Study Treatment|The estimated distribution of OS will be obtained using the product-limit based Kaplan-Meier method.|Up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
60782|NCT01198548|Secondary|Toxicity Rates as Assessed by NCI CTCAE Version 4||Up to 30 days post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
60783|NCT01198548|Secondary|RR of Patients Receiving Study Treatment||Up to 3 years|Trial terminated early. Too few patients to analyze.|||||
60784|NCT01198548|Primary|Rate of Sufficient Cholecalciferol||By week 16|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
60785|NCT01198548|Primary|Median PFS|The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.|Up to 12 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
60786|NCT01198509|Secondary|Mean Units Change in DAS28 From Baseline to 6 Months|"DAS28 (disease activity score with 28 joint count). Possible score range: 0 to 10. This is a composite index calculated from 4 measures: two from a physician (28 tender joint count, 28 swollen joint count), one from the patient (patient global estimate of disease activity), and one laboratory biomarker (erythrocyte sedimentation rate or ESR). A score of 0 represents best possible health status (no apparent disease activity) and 10 represents worst possible.~The outcome is reported as mean change in DAS28 score from baseline to 6 months. The mean changes reported are negative values for downward change in score (i.e., improvement in health status)."|6 months|Please note that only the first 3 groups (RA doxycycline, RA vancomycin, and RA randomized to no treatment) were analyzed for change from baseline to six months (outcomes). Groups 4, 5 and 6 (RA cross-sectional, Psoriatic Arthritis, and Healthy Volunteers) were analyzed for baseline measures only in a cross-sectional comparison.||units on a scale||Full Range|Mean
60808|NCT01197911|Secondary|Mean of Fraction of Unbound Aleglitazar (fu)|fu was calculated using the mean of the 2-hour (reflecting Cmax) and 24-hour (reflecting Ctrough) values for each participant or, if the result of only one time-point was available, fu was the result of the available time-point. Ctrough) is a measured concentration at the end of a dosing interval at steady state.|2 and 24 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||Percentage||Geometric Coefficient of Variation|Geometric Mean
60787|NCT01198509|Primary|Alteration of Microbiota, Alteration of T Cell Function/Activation|"Oral and intestinal microbiota, and T cell function and activation, will be assessed at baseline, and at 1, 2, 3, 4 and 5 months after baseline, to determine whether changes are associated with vancomycin treatment versus doxycycline treatment versus no treatment.~Results are reported as number of participants who experienced changes in oral/intestinal microbiota, T cell function/activation.~Methods/criteria to assess change in microbiota: change in relative abundance of microorganisms at genus and species level (as assessed high-throughput 16S rDNA sequencing).~Methods/criteria to assess change in T cell function/activation: change in percentage of inhibition of regulatory T cells as measured by interferon gamma levels in in-vitro assays."|6 months|Primary outcome only evaluated in first three groups of RA patients: 4 randomized to treatment with doxycycline; 10 randomized to treatment with vancomycin; 19 randomized to no treatment.||participants|||Number
60788|NCT01198366|Secondary|Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination|To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on >= 0.35IU/mL was considered positive for this study.|up to 24 months post vaccination|Subjects who received at least one vaccination and had results at baseline and end of study.||% converting from QFT neg to pos|||Number
60789|NCT01198366|Secondary|Antigen-specific Antibody Response - Mean Optical Density (Mean OD)|To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).|28 day post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Ag85A and TB10.4).~Assays were not done for groups 2 and 3 for any antigen. Group 5: Subjects who received all three study vaccinations as randomized."||Optical Density||95% Confidence Interval|Median
60790|NCT01198366|Secondary|Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay|To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.|28 days post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Groups 2 and 3).~Group 5: Subjects who received all three study vaccinations as randomized."||SFU/10^6 PBMC||95% Confidence Interval|Median
60791|NCT01198366|Secondary|Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects|To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.|28 days post last vaccination|Groups 1–4: Subjects who received both vaccinations as randomized. Group 5: Subjects who received all three study vaccinations as randomized.||percentage of Tcell response||95% Confidence Interval|Median
60792|NCT01198366|Primary|Adverse Events Collected Per Subject|Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile|Up to 24 months post vaccination|Subjects who received at least one vaccination.||percentage of subjects with an AE|||Number
60793|NCT01198327|Secondary|Mean Change in Retinal Thickness|Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).|24 mos from study baseline|||microns||Standard Deviation|Mean
60794|NCT01198327|Secondary|Mean Changes in Visual Acuity|Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.|24 mos from study baseline|||ETDRS letters||Standard Deviation|Mean
60795|NCT01198327|Primary|Incidence of Serious Adverse Events.|Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.|24 mos|||number of serious adverse events|||Number
60796|NCT01198275|Primary|Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)|Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.|one year|||partecipants|||Number
60797|NCT01198275|Secondary|The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence|The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.|1, 3 and 6 months||07/2011||||
60798|NCT01197911|Secondary|Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters|Laboratory parameters included hematology, coagulation, biochemistry, and urinalysis. A marked abnormality was defined as a test result which was outside of the marked abnormality range. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
60799|NCT01197911|Secondary|Number of Participants With Low and High Vital Signs Values|Vital signs were assessed after participants had rested in a supine position for no less than 5 minutes. Vital signs included systolic blood pressure, diastolic blood pressure, pulse rate, and oral body temperature. The normal ranges of vital signs were: systolic blood pressure as 90-140 millimeter of Hg (mm Hg), diastolic blood pressure as 50-90 mm Hg, pulse rate as 45-100 beats per minute, and oral body temperature as 36.3-37.5 degree Celsius. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Days -28 to -2, Day -1, Days 1 to 5, and Day 10 for blood pressure and pulse rate; and Days -28 to -2, Day -1, and Day 10 for oral body temperature|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
73804|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and 52 week after|||percentage of Neutrophils||Standard Deviation|Mean
60800|NCT01197911|Secondary|Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values|The ECG evaluations were performed after participants were at rest and in supine position for at least 5 minutes before recording and remain resting and supine during the recordings. ECGs parameters included heart rate (HR), RR interval, PR interval, QRS duration, QT interval, QTcB, and QTcF intervals. The normal ranges of ECG parameter values were: HR as 40-100 beats per minute, RR as 600-1500 milliseconds (msec), PR as 120-200 msec, QRS as 80-120 msec, QT as 200-500 msec, QTcB as 350-450 msec, and QTcF as 350-450 msec. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Screening (Days -28 to -2), baseline (Day -1), Days 1 to 5, and follow-up visit (Day 10)|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
60801|NCT01197911|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.||participants|||Number
60802|NCT01197911|Secondary|Apparent Unbound Total Body Clearance (CL/Fu) of Aleglitazar|CL/F is an apparent total clearance of the drug from plasma after oral administration. It was calculated as dose/AUCinf. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific study drug/metabolite were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
60803|NCT01197911|Secondary|Apparent Unbound Volume of Distribution (Vz/Fu) of Aleglitazar|VzF/u is an apparent volume of Unbound distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||L||Geometric Coefficient of Variation|Geometric Mean
60804|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to 48 Hours Post-dose (AUCu,0-48)|AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
60805|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From 0 to the Last Quantifiable Time-point Post-dose (AUCu,Last)|Plasma samples were collected for this PK parameter. AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero 0 to the last quantifiable time-point post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. AUClast was extrapolated to AUCinf by adding the ratio of Clast/kel to the AUClast, where Clast was the last observed concentration and kel was elimination rate constant.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
60806|NCT01197911|Secondary|Maximum Unbound Plasma Concentration (Cmax,u) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
60807|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to Infinity (AUCu,Inf)|AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. It was assessed using an analysis of variance model on the log-transformed values of AUCinf of aleglitazar with hepatic impairment group as factor.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
60820|NCT01197911|Secondary|Cmax of M1 and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
60809|NCT01197911|Secondary|Fraction of Drug Excreted in Urine From Time 0 to 48 Hours Post-dose (fe0-48) of Aleglitazar|fe0-48 was calculated as Ae0-48/dose. The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours. Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.||mcg||Geometric Coefficient of Variation|Geometric Mean
60810|NCT01197911|Secondary|Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6|The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours, where Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||mcg||Geometric Coefficient of Variation|Geometric Mean
60811|NCT01197911|Secondary|Apparent Volume of Distribution (Vz/F) of Aleglitazar|Vz/F is the apparent volume of distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||L||Geometric Coefficient of Variation|Geometric Mean
60812|NCT01197911|Secondary|Elimination Rate Constant (Kel) of Aleglitazar|The kel is fraction of a substance that is removed per unit time measured at any particular instant. It was calculated using at least 3 concentration-time points and ideally covered more than 2 half-lives.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||1/h||Geometric Coefficient of Variation|Geometric Mean
60813|NCT01197911|Secondary|Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h||Geometric Coefficient of Variation|Geometric Mean
60814|NCT01197911|Secondary|Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Tmax was measured as time to reach the maximum concentration in the plasma after post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||h||Full Range|Mean
60815|NCT01197911|Secondary|Apparent Non-renal Clearance (CLNR/F) of Aleglitazar|Plasma and urine samples were collected for this PK parameter. CLNR/F was estimated as CL/F, based on the approximated formula of CLNR/F = (CL-CLR)/F with CLR of aleglitazar being equal to zero. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time zero to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
60816|NCT01197911|Secondary|Renal Clearance (CLR) of Aleglitazar, M1, and M6|CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time 0 to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72, and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
60817|NCT01197911|Secondary|Apparent Total Body Clearance (CL/F) of Aleglitazar|CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.||L/h||Geometric Coefficient of Variation|Geometric Mean
60818|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6|AUClast was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
60819|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUC0-48 was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
60821|NCT01197911|Primary|Maximum Plasma Concentration (Cmax) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
60822|NCT01197911|Secondary|AUCinf of M1 (RO4408754) and M6 (RO4583746)|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
60823|NCT01197911|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar|AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.||hours (h)*nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
60824|NCT01197898|Primary|Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.|The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.|28 Days|Goal was to complete 10 subjects in an allocation ratio of 1:1 for Santyl vs. placebo. Since this was an exploratory study, the sample size was arbitrary.||participants|||Number
60825|NCT01197833|Primary|Absolute Change From Baseline in PA-V3 Score|The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from “Not at all noticeable” (a score of 0) to “Extremely noticeable” (a score of 4)|PA-V3 measured at baseline and then at 8 weeks|||score||Standard Error|Least Squares Mean
60826|NCT01197833|Primary|Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)|The Independent Photography Review – Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient’s visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient’s varicose veins in the medial section of each leg (a ‘live’ assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient’s varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient’s visible varicose veins.|IPR-V3 measured at baseline and then at 8 weeks|||score||Standard Error|Least Squares Mean
60827|NCT01197794|Secondary|Total Reliever Medication Use|Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Number of inhalations||95% Confidence Interval|Least Squares Mean
60828|NCT01197794|Secondary|Asthma Symptom Score|Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Score on scale||95% Confidence Interval|Least Squares Mean
60829|NCT01197794|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S))|The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Score on scale||95% Confidence Interval|Least Squares Mean
60830|NCT01197794|Secondary|Number of Participants With Well-controlled Asthma (ACQ5<=0.75)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Participants|||Number
60831|NCT01197794|Secondary|Number of Participants With at Least One Treatment Failure|Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Participants|||Number
60913|NCT01197417|Secondary|Warm Sensation Associated With Study Drug Infusion|Patient spontaneously reported feelings of warmth during any study drug infusion.|Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug.||Participant|||Number
60832|NCT01197794|Secondary|Number of Participants With at Least One Severe Asthma Exacerbation|Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Participants|||Number
60833|NCT01197794|Secondary|Adverse Events|Number of participants who had at least one adverse event during the randomized treatment period|Twelve week treatment period|All randomized participants who received at least one dose of study medication and from whom any data after randomization was available||Participants|||Number
60834|NCT01197794|Secondary|Asthma Control Questionnaire 5-item (ACQ5)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Scores on scale||95% Confidence Interval|Least Squares Mean
60835|NCT01197794|Secondary|Morning and Evening PEF|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Liters/minute||95% Confidence Interval|Least Squares Mean
60836|NCT01197794|Primary|Pre-bronchodilator FEV1 at the Clinic|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint||Liters||95% Confidence Interval|Least Squares Mean
60837|NCT01197755|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. The SF-36 scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in score at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
60838|NCT01197755|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
60839|NCT01197755|Secondary|Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for eroisions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = Analysis of covariance, BID = twice daily, IP = investigational product, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.||Units on a scale||Standard Deviation|Mean
60840|NCT01197755|Secondary|Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60841|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 24 was categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60842|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60843|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60844|NCT01197755|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 24. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
60845|NCT01197755|Secondary|Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60846|NCT01197755|Secondary|Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60847|NCT01197755|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60848|NCT01197755|Primary|Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60849|NCT01197560|Secondary|Stage 2: Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) Patients|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) is a 30-item oncology-specific questionnaire developed to assess the quality of life of cancer patients. The descriptive system EQ-5D is a generic questionnaire consisting of 3 levels within each of the 5 domains. It’s is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
61000|NCT01196104|Secondary|Mild or Moderate Hypoglycemic Event Rate|"Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Nonsevere hypoglycemia is defined as a subject:~SMBG levels < 70 mg/dL AND/OR~Symptoms that are relieved by the self-administration of carbohydrates"|Baseline to Week 16|Safety Population||Events / subject-month|||Number
60850|NCT01197560|Secondary|Stage 2: Time to Progression for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Time to progression is defined as the time from the start of study drug therapy to the first documentation of disease progression||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60851|NCT01197560|Secondary|Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Patients With a Duration of Response Lasting ≥ 16 Weeks|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).~Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.~CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.~Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60852|NCT01197560|Secondary|Stage 2: Duration of Complete Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Duration of Complete Response was to be calculated for complete responders as the time of from documented initial complete response (either CR or CRu) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60853|NCT01197560|Secondary|Stage 2: Overall Survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Overall Survival (OS) is defined as the time from randomization until death due to any cause.||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60854|NCT01197560|Secondary|Stage 2: Duration of Overall Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) was to be calculated for responders as the time from documented initial response (either CR, CRu, or PR) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.|Approximately 3.5 years|According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60855|NCT01197560|Secondary|Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).~Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.~CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.~Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60856|NCT01197560|Secondary|Stage 2: Complete Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|"Complete Response Rate (CR + CRu rate) was to be calculated as the proportion of participants achieving a CR or CRu using 1999 IWG Response Criteria, (Cheson, 1999).~CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia)."||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60857|NCT01197560|Primary|Stage 2: Progression-free Survival for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Number of participants who survive without progressing based on the International Working Group Response Criteria [IWG].||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.|||||
60864|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
61099|NCT01195779|Primary|Geometric Mean Number of All-CD4 Cytokine Positive Cells|Geometric mean of the number of CD4 cytokine positive T cells per million T cells.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
60858|NCT01197560|Primary|Stage 1: Percentage of Participants With an Overall Response Rate (ORR) According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999.|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL as evaluated by the Independent Response Adjudication Committee (IRAC).~Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.~CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.~Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"|From Sept 2010 to the data cut-off of 4 July 2013; when all participants had reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment). Median follow-up time was 6.7 and 4.7 months in each arm respectively|The Modified Intent to Treat (mITT ) population was defined as all participants randomized who had a DLBCL diagnosis and either Germinal Center B-cell subtype (GCB) or non-GCB subtype confirmed by Central Pathology, and who received at least one dose of study drug (lenalidomide or Investigator’s choice).||percentage of participants||95% Confidence Interval|Number
60859|NCT01197534|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
60860|NCT01197534|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
60861|NCT01197534|Secondary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.||Units on a scale||Standard Deviation|Mean
60862|NCT01197534|Secondary|HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60863|NCT01197534|Secondary|Proportion of Patients Achieving DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60914|NCT01197417|Secondary|Hypotension Associated With Infusion|For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.|Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug||Participant|||Number
60865|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60866|NCT01197534|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient’s own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID = twice daily, CI = confidence interval, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. Mean refers to change at Week 24.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
60867|NCT01197534|Secondary|Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60868|NCT01197534|Secondary|Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60869|NCT01197534|Secondary|Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60870|NCT01197534|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60871|NCT01197521|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle||Units on a scale||Standard Deviation|Mean
60872|NCT01197521|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle||Units on a scale||Standard Deviation|Mean
61100|NCT01195779|Primary|Serum Neutralizing Antibody Titers||at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
60873|NCT01197521|Secondary|HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60874|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60875|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60876|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60877|NCT01197521|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage improvement from baseline||Standard Deviation|Mean
60878|NCT01197521|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60879|NCT01197521|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60880|NCT01197521|Secondary|ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60889|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60881|NCT01197521|Primary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.|mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of IP. Patients were analysed by randomised treatment. Measurements at 2 timepoints are required in order for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.||Units on a scale||Standard Deviation|Mean
60882|NCT01197521|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.||Percentage of responders|||Number
60883|NCT01197508|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60884|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60885|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60886|NCT01197508|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60887|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60888|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
61101|NCT01195779|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
60890|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60891|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60892|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60893|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60894|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60895|NCT01197508|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)|||units on a scale||Standard Error|Least Squares Mean
60896|NCT01197508|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
60897|NCT01197508|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60898|NCT01197508|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60899|NCT01197508|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
61152|NCT01195584|Secondary|Operation Duration|Duration of the operation in minutes.|after surgery|analysis per protocol||Minutes||Standard Deviation|Mean
60900|NCT01197508|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
60901|NCT01197508|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
60902|NCT01197508|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
60903|NCT01197508|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
60904|NCT01197508|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
60905|NCT01197495|Secondary|Duration Effect of Treatment on Lip Fullness|Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.|Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12|Modified Intent-to-Treat: all treated subjects with data at the designated time point||% of Pts Retaining ≥1-point Improvement||95% Confidence Interval|Number
60906|NCT01197495|Secondary|Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness|Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'|Baseline, Month 3|Treated subjects in the Treatment group||Percentage of Subjects|||Number
60907|NCT01197495|Secondary|Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale|Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).|Baseline, Month 3|Subjects treated for OCS at the designated time points||Percentage of Oral Commissures|Participants||Number
60908|NCT01197495|Secondary|Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale|Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).|Baseline, Month 3|Subjects treated for POL at the designated time points||Percentage of Subjects|||Number
60909|NCT01197495|Primary|Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)|Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.|Baseline, Month 3|Modified Intent-to-Treat: all treated subjects with data at the designated time point||Percentage of Subjects||95% Confidence Interval|Number
60910|NCT01197417|Secondary|Hospital Length of Stay||Start of first study drug infusion to actual hospital discharge|||Hours||Inter-Quartile Range|Median
60911|NCT01197417|Secondary|Development of Acute Chest Syndrome (ACS)||Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment|||Paricipants|||Number
60912|NCT01197417|Secondary|Rehospitalization||Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)|All participants who received at least one dose of study drug who had known rehospitalization status within 7 days||Participant|||Number
60915|NCT01197417|Secondary|Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization||Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to either hospital discharge or 12 hours after last intravenous opioid.||mg Morphine/kg||Inter-Quartile Range|Median
60916|NCT01197417|Primary|Hospital Length of Stay (Hours)||From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to outcome||hours||Inter-Quartile Range|Median
60917|NCT01197326|Secondary|Respiration Rate Impact on RRT Calls|Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.|6 months|||percentage of calls|||Number
60918|NCT01197326|Primary|Survival|Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)|6 months|||percentage of participants|||Number
60919|NCT01196988|Secondary|Number of Days With Solicited General Symptoms|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)].|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||days||Inter-Quartile Range|Median
60920|NCT01196988|Secondary|Number of Days With Solicited Local Symptoms.|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||days||Inter-Quartile Range|Median
60921|NCT01196988|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.||subjects|||Number
60922|NCT01196988|Secondary|Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results||subjects|||Number
60923|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.||subjects|||Number
60924|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 28-day (Days 0-27) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.||subjects|||Number
60925|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||subjects|||Number
60926|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.||subjects|||Number
60973|NCT01196741|Secondary|Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~Time To Progression will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||||
60927|NCT01196988|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child <6 years) or pain that prevented normal activity (Child >6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom completed.||subjects|||Number
60928|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
60929|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
60930|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
60931|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60932|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60933|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60934|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60992|NCT01196104|Secondary|Week 20 (Follow-up) Forced Expiratory Volume in 1 Second|Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment|Week 20 (Follow-up)|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
60993|NCT01196104|Secondary|Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second|Week 16 Change from Baseline in FEV1|Baseline to Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
60935|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60936|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60937|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60938|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60939|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60940|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60941|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60942|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).~Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
60994|NCT01196104|Secondary|Week 16 Forced Expiratory Volume in 1 Second|Week 16 FEV1|Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
60995|NCT01196104|Secondary|Baseline Forced Expiratory Volume in 1 Second (FEV1)|Baseline FEV1|Baseline|Safety Population||L||Standard Deviation|Mean
60943|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).~Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
60944|NCT01196988|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
60945|NCT01196988|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
60946|NCT01196975|Secondary|Number of Days With Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.|Within the 21-day (Days 0-20) follow-up period post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||||
60947|NCT01196975|Secondary|Number of Days With Solicited General Symptoms After Vaccination|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||||
60948|NCT01196975|Secondary|Number of Days With Solicited Local Symptoms After Vaccination.|Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||||
60949|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
60950|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature – oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||Subject|||Number
60951|NCT01196975|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||Subject|||Number
60970|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
60952|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
60953|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
60954|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
60955|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
60956|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.||Titer||95% Confidence Interval|Geometric Mean
60957|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titer||95% Confidence Interval|Geometric Mean
60958|NCT01196975|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
60959|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
60960|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
60961|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
60962|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subject|||Number
60963|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subject|||Number
60964|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.||Titer||95% Confidence Interval|Geometric Mean
60965|NCT01196975|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
60966|NCT01196975|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.||Subject|||Number
60967|NCT01196975|Secondary|Number of Subjects With Related Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.|||||
60968|NCT01196975|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.||Subject|||Number
60969|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol with available assay results for assessed antibodies in Day 180 blood samples.||titer||95% Confidence Interval|Geometric Mean
60974|NCT01196741|Secondary|Quality of Life: Trial Outcome Index (TOI) Based on FACT-O|"The TOI value for each patient is derived at each timepoint by calculating the sum of 3 subscales: Physical Well-Being (PWB), Functional Well-Being (FWB), Additional Concerns. Each subscale score is derived from questions with 4 answers (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). In each subscale reversals are performed and the individual question scores added together. This value is then multiplied by the number of questions within the subscale, and divided by the number of questions answered to derive a subscale score. The higher each subscale score, the better the QoL.~PWB 7 questions, lower values=better QoL.~FWB 7 questions, higher values=better QoL.~Additional concerns 11 questions (higher values in 6 questions=better QoL; higher values in 5 questions=worse QoL)~The TOI is reported for each arm based on the average TOI score of each patient calculated across the outcome measure time frame. The higher the TOI, the better the QoL."|Patients will fill in FACT-O questionnaires at the following timepoints: baseline; Weeks 1, 3 and 6 of every chemotherapy cycle; at every follow up visit|||units on a scale||Standard Error|Mean
60975|NCT01196741|Secondary|Median Duration of Response|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~Duration of Response will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||||
60976|NCT01196741|Secondary|Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria|Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||percentage of participants|||Number
60977|NCT01196741|Secondary|Overall Survival||First saracatinib/placebo dose until death, assessed up to 36 months|||months||Full Range|Median
60978|NCT01196741|Primary|6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria)|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~The 6 month progression-free survival rate will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||percentage of participants||90% Confidence Interval|Number
60979|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Month 3|||units on a scale||Standard Error|Least Squares Mean
60980|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 2|||units on a scale||Standard Error|Least Squares Mean
60981|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 1|||units on a scale||Standard Error|Least Squares Mean
60982|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 10|||units on a scale||Standard Error|Least Squares Mean
60983|NCT01196442|Secondary|Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics|Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most|From day 1 to day 30|||doses||Standard Deviation|Mean
60984|NCT01196442|Secondary|Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 1|Participants at Day 1||units on a scale||Standard Error|Least Squares Mean
60985|NCT01196442|Primary|Change in Pain Score From Day 1 to Day 10|"Change in Brief Pain Inventory (Now)Scale~1 (none) to 5 (complete interference)"|From day 1 to day 10|||units on a scale||Standard Deviation|Mean
60986|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC|Baseline to Week 20|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
60987|NCT01196104|Secondary|Week 20 (Follow-up) Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC|Week 20|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
60988|NCT01196104|Secondary|Week 16 Change From Baseline Forced Vital Capacity|Week 16 Change from Baseline FVC|Baseline to Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
60989|NCT01196104|Secondary|Week 16 Forced Vital Capacity|Week 16 FVC|Week 16|Safety Population, with data available at Week 16||L||Standard Deviation|Mean
60990|NCT01196104|Secondary|Baseline Forced Vital Capacity (FVC)|Baseline FVC|Baseline|Safety Population||L||Standard Deviation|Mean
60991|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1|Baseline to Week 20|Safety Population, with data available at Week 20||L||Standard Deviation|Mean
61001|NCT01196104|Secondary|Severe Hypoglycemic Event Rate|"Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:~SMBG levels ≤ 36 mg/dL OR~There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures"|Baseline to Week 16|Safety Population||Events / subject-month|||Number
61002|NCT01196104|Secondary|Total Number of Cough Episodes|Total number of times patients coughed once, intermittently or continuously (inclusive)|Baseline to Week 16|Safety Population||Cough episodes|||Number
61003|NCT01196104|Secondary|Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61004|NCT01196104|Secondary|Changes in Body Weight at 16 Weeks|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61005|NCT01196104|Secondary|Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61006|NCT01196104|Secondary|Seven-point Glucose at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61007|NCT01196104|Secondary|Glycomark and Fructosamine Levels Measured Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61008|NCT01196104|Secondary|Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61009|NCT01196104|Secondary|Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61010|NCT01196104|Secondary|To Evaluate the Effect of Each Treatment on HbA1c|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks||||||
61011|NCT01196104|Primary|Change in HbA1c (%) From Baseline to Week 16|Change from Baseline in glycated hemoglobin at Week 16|Baseline to Week 16|Safety Population, participants with data available at Baseline and Week 16||Percentage of total hemoglobin||Standard Deviation|Least Squares Mean
61012|NCT01196078|Secondary|Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
61013|NCT01196078|Secondary|Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
61014|NCT01196078|Secondary|Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change|The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
61015|NCT01196078|Secondary|Changes in Quality of Life as Measured by the FACT Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
61027|NCT01196052|Secondary|Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment|Participants were to receive up to a total of 17 cycles of trastuzumab emtansine. If trastuzumab was given concurrently with either the optional docetaxel or optional radiation, then the number of 3-week cycles of trastuzumab therapy was subtracted from the planned 17 cycles of trastuzumab emtansine therapy.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.||Percentage of participants|||Number
71227|NCT01095757|Primary|Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis||Within the first 4 days following the first dose of Plerixafor|||participants|||Number
61016|NCT01196078|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
61017|NCT01196078|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population||months||95% Confidence Interval|Median
61018|NCT01196078|Secondary|Overall Survival: Percentage of Participants With an Progressive Disease or Death|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population||percentage of participants|||Number
61019|NCT01196078|Secondary|Time to Disease Progression|Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population||months||95% Confidence Interval|Median
61020|NCT01196078|Secondary|Percentage of Participants With Disease Progression|Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population||percentage of participants|||Number
61021|NCT01196078|Secondary|Duration of Response Among Participants Who Achieved Either a CR or PR|Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.|Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up|ITT population; only participants with a response (CR or PR) were included in the analysis.||months||95% Confidence Interval|Median
61022|NCT01196078|Secondary|Percentage of Participants Achieving Disease Control|Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT Population||percentage of participants|||Number
61023|NCT01196078|Primary|Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)|CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT population||percentage of participants|||Number
61024|NCT01196052|Secondary|Disease-free Survival at Month 12|Disease-free survival was defined as the time from date of first protocol treatment for adjuvant patients or date of surgery for neoadjuvant patients to disease recurrence, occurrence of invasive contralateral breast cancer, other second primary cancer (excluding non-breast second primary), or death, whichever occurred first.|From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later|"Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.~Due to too few events, the analysis of disease-free survival was not performed."|||||
61025|NCT01196052|Secondary|Percentage of Participants With a Pathological Complete Response|Pathological complete response was defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes after surgery following primary systemic therapy. Pathological complete response was evaluated in participants treated with neoadjuvant therapy doxorubicin/cyclophosphamide-5-fluorouracil/epirubicin/cyclophosphamide followed by 1 or more doses of trastuzumab emtansine and who underwent surgery.|Day of surgery|Efficacy analysis population: All participants who enrolled in the neoadjuvant setting and received surgery, after completing 4 cycles of trastuzumab emtansine treatment.||Percentage of participants||95% Confidence Interval|Number
61026|NCT01196052|Secondary|Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay||From the start to the end of radiotherapy treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy and who had radiotherapy dose information reported were included in the analysis.||Percentage of participants|||Number
61238|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.||Participants|||Number
61028|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent hormonal therapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent hormonal therapy were included in the analysis.||Percentage of participants|||Number
61029|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent radiotherapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy were included in the analysis.||Percentage of participants|||Number
61030|NCT01196052|Primary|Adverse Events, LVEF Function, and Deaths|The following percentages of participants are reported: At least 1 adverse event while receiving T-DM1; at least 1 serious adverse event while receiving T-DM1; an adverse event leading to discontinuation, dose delay, or dose reduction of trastuzumab emtansine treatment; symptomatic cardiac dysfunction; and asymptomatic decline in left ventricular ejection fraction (LVEF). An asymptomatic LVEF decline was defined as a LVEF < 50% and a maximum decrease ≥ 10% from Baseline. The percentage of participants who died is reported.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.||Percentage of participants|||Number
61031|NCT01196052|Primary|Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment|A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of < 50%.|Baseline to 12 weeks after the start of trastuzumab emtansine treatment|Cardiac-safety evaluable population: All participants who received at least 1 dose of T-DM1 and met either of the following 2 criteria: (1) Had an echocardiogram/multiple-gated acquisition assessment by 12 weeks after the first dose of T-DM1 or (2) discontinued study treatment because of cardiac toxicity prior to completion of 4 cycles of T-DM1.||Percentage of participants||95% Confidence Interval|Number
61032|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
61033|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Day 28|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
61034|NCT01196026|Secondary|Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest|"MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.~AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis."|During the entire study period (up to Month 6)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
61035|NCT01196026|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any was defined as any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Day 0-27) after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||subjects|||Number
61036|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.||days||Inter-Quartile Range|Median
61037|NCT01196026|Secondary|Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.||subjects|||Number
61038|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.||days||Inter-Quartile Range|Median
61096|NCT01195779|Secondary|Serum Neutralising Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
61275|NCT01194440|Secondary|Menopausal Symptoms||12 months||||||
61276|NCT01194440|Secondary|Amount and/or Frequency of Oral Analgesic||12 months||||||
61039|NCT01196026|Secondary|Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0–6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.||subjects|||Number
61040|NCT01196026|Secondary|Duration of Any Solicited Local Symptom|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.|During the 7 days (Days 0 – 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.||days||Inter-Quartile Range|Median
61041|NCT01196026|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.|During the 7 days (Day 0 – 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.||subjects|||Number
61042|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
61043|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix|Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||subjects|||Number
61044|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
61045|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:28.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||subjects|||Number
61046|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||titer||95% Confidence Interval|Geometric Mean
61047|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as Geometric Mean Titers (GMTs).|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||titer||90% Confidence Interval|Geometric Mean
61048|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||ratio||95% Confidence Interval|Geometric Mean
61049|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||ratio||95% Confidence Interval|Geometric Mean
61050|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
61277|NCT01194440|Secondary|Visual Analog Scale||12 months||||||
61051|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.||subjects|||Number
61052|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
61053|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains."|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.||subjects|||Number
61054|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||subjects|||Number
61055|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.||subjects|||Number
61056|NCT01196026|Secondary|HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.||titer||95% Confidence Interval|Geometric Mean
61057|NCT01196026|Secondary|HI Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.||titer||95% Confidence Interval|Mean
61058|NCT01196026|Primary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||ratio||95% Confidence Interval|Geometric Mean
61059|NCT01196026|Primary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||subjects|||Number
61060|NCT01196026|Primary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||subjects|||Number
61061|NCT01196026|Primary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||subjects|||Number
61097|NCT01195779|Secondary|Serum HI Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
61062|NCT01196026|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs).|Day 0 and 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.||titer||95% Confidence Interval|Geometric Mean
61063|NCT01195948|Secondary|Changes in High-speed Indocyanine Green Angiography (HS-ICG)||Week 24||||||
61064|NCT01195948|Secondary|Reduction in Exposure to Corticosteroid as Measured by the Area Under the Dose-time Curve.||Week 24||||||
61065|NCT01195948|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||participants|||Number
61066|NCT01195948|Secondary|Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||participants|||Number
61067|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||ETDRS letters||Full Range|Mean
61068|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||ETDRS letters||Full Range|Mean
61069|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 52|Twenty-five (25) participants completed Week 52. Three completed prior to Week 52 as a result of early study closure (1/group), two placebo participants and one 4 mg participant were lost to follow-up at Weeks 10, 44 and 28, respectively.||participants|||Number
61070|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.||participants|||Number
61071|NCT01195948|Primary|The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication.|"Recurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system.~The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation."|Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks|||weeks||Inter-Quartile Range|Median
61072|NCT01195922|Primary|Percent (%) Change in Clinical and Laboratory Evaluations for Safety||Percent (%) change from Pre to Post treatement (~21 days)|Same sample loss during processing for phosphor and magnesium||percentage change from baseline||Standard Deviation|Mean
61073|NCT01195922|Primary|Percent (%) Changes in Tumor Size, Blood Flow, and Standardized Uptake Value||21 days post treatment with rapamycin|It was not possible to obtain appropriate CT scans or SUV measurement from all participants||percentage change from baseline||Standard Deviation|Mean
61074|NCT01195922|Primary|Percent (%) Change in Levels of pS6, pAKt473, and Ki-67||21 days post treatment with rapamycin|paraffin embedded formalin fixed tissues including head and neck cancer lesion were not available for 2 participants||percentage of change from baseline||Standard Deviation|Mean
61075|NCT01195844|Primary|The Number of Deaths in Hospitalized Participants Enrolled in the Study|The number of deaths among children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|Participants were not followed-up in the study; thus the number of deaths was not known.|||||
61076|NCT01195844|Primary|The Duration of Hospitalization for Participants Enrolled in the Study|The mean duration (days) of hospital stay for children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|From hospital admission to discharge|The population analyzed was all enrolled participants whether or not a fecal sample was obtained.||days||Standard Deviation|Mean
61077|NCT01195844|Primary|The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained||Participants|||Number
61078|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was reported for each age group.|1 year|The population analyzed was the 27 of 190 participants who had a fecal sample positive for rotavirus.||participants|||Number
61079|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers.|1 year|Children hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers||percentage of participants||95% Confidence Interval|Number
61080|NCT01195844|Primary|The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. For each geographic location, the number of hospitalizations for diarrhea that was caused by rotavirus was reported.|1 year|The population analyzed was children up to 5 years of age hospitalized for diarrhea. A total of 190 of the 230 participants had fecal samples analyzed; 27 of these had stool samples positive for rotavirus.||Participants|||Number
61081|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The percentage of total hospitalizations for children up to 5 years of age in the 4 Brazilian hospital research centers that were for diarrhea. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|"The population to be analyzed was all hospitalizations for any reason for children up to 5 years of age in the 4 hospital research centers~The number of total hospitalizations for children up to 5 years of age was not known; thus this outcome measure was not evaluated"|||||
61082|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The total number of hospitalizations for diarrhea in children up to 5 years of age in the 4 Brazilian hospital research centers was reported. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained||participants|||Number
61083|NCT01195831|Secondary|Evaluation of the Quality of Life||Baseline to weeks 2 and 4||||||
61084|NCT01195831|Secondary|Patients With Success (Patient's Itching Score=None) at Week 4||4 weeks||||||
61085|NCT01195831|Secondary|For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4||4 weeks||||||
61086|NCT01195831|Secondary|Patients With Success (Total Sign Score ≤1) at Week 4|"Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved Success."|4 weeks|||percentage of participants|||Number
61087|NCT01195831|Secondary|"Patients With Controlled Disease in Term of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 4."|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|4 weeks|||percentage of participants|||Number
61088|NCT01195831|Secondary|Patients With “Controlled Disease” in Terms of “Clear” or “Very Mild” According to Patient’s Global Assessment of Disease Severity at Week 2.|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|2 weeks|||percentage of participants|||Number
61089|NCT01195831|Secondary|Patients With “Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 2|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease.|2 weeks|||percentage of participants|||Number
61090|NCT01195831|Primary|Patients With ”Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 4.|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.|4 weeks|||percentage of parcipitants|||Number
61091|NCT01195779|Secondary|Number of Subjects Reporting Serious Adverse Events|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 179|||Subjects|||Number
61092|NCT01195779|Secondary|Number of Subjects Reporting Potential Immune-mediated Diseases|Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
61093|NCT01195779|Secondary|Number of Subjects Reporting Adverse Events With Medically Attended Visits|A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
61094|NCT01195779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 28 days (Day 0 to Day 27) after any vaccination|||Subjects|||Number
61095|NCT01195779|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.|during a 7 day follow-up period (Day 0 to 6) after any vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
61102|NCT01195701|Secondary|FSFI Pain|The pain domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of discomfort or pain during and following vaginal penetration (almost never to almost always), and the level of discomfort or pain (very low to very high). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the pain score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
61103|NCT01195701|Secondary|FSFI Satisfaction|The satisfaction domain of the Female Sexual Function Index (FSFI) consists of three questions and measures satisfaction (very dissatisfied to very satisfied) with emotional closeness with partner, sexual relationship with partner, and overall sexual relationship with partner. Item scores range from 0 (or 1) to 5, with higher scores indicating better sexual function, and the satisfaction score is weighted by a factor of 0.4, such that the domain score can range from 0.8 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
61104|NCT01195701|Secondary|FSFI Orgasm|The orgasm domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of orgasm (almost never to almost always), difficulty in achieving orgasm (extremely difficult to not difficult), and satisfaction with the ability to reach orgasm (very dissatisfied to very satisfied). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the orgasm score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
61105|NCT01195701|Secondary|FSFI Lubrication|The lubrication domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency of lubrication (almost never to almost always), the difficulty in becoming lubricated (extremely difficult to not difficult), frequency of maintaining lubrication (almost never to almost always), and difficulty in maintaining lubrication (extremely difficult to not difficult). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the lubrication score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
61106|NCT01195701|Secondary|FSFI Arousal|The arousal domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual arousal; and confidence in becoming aroused (very low to very high confidence) and frequency of satisfaction with arousal (almost never to almost always). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the arousal score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
61107|NCT01195701|Secondary|FSFI Desire|The desire domain of the Female Sexual Function Index (FSFI) consists of two questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual desire. Item scores range from 1 to 5, with higher scores indicating better sexual function, and the domain score is weighted by a factor of 0.6, such that the domain score can range from 1.2 to 6.0.|baseline visit|||units on a scale||Standard Deviation|Mean
61108|NCT01195701|Secondary|Female Sexual Function Index (FSFI) Total Score|The FSFI is a validated index of sexual function, consisting of a total score and six subscales or domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total is the sum of the six domain scores, each of which is weighted as noted. The FSFI total score can range from 2 to 36, with higher scores indicating better sexual function. A total score of 26.55 has been identified as the ideal cut point for differentiating between normal sexual function and sexual dysfunction.|baseline visit|||units on a scale||Standard Deviation|Mean
61109|NCT01195701|Secondary|Free Androgen Index|Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)|Between day 1-14 (follicular phase) of menstrual cycle|||ratio||95% Confidence Interval|Number
61110|NCT01195701|Secondary|Total Testosterone|Free & total testosterone, and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle|||ng/dL||Inter-Quartile Range|Median
61111|NCT01195701|Secondary|Free Testosterone|Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle|||pg/mL||Inter-Quartile Range|Median
61112|NCT01195701|Primary|Clitoral Measurements Using Pelvic MRI|All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.|Between day 1-14 (follicular phase) of menstrual cycle|||millimeters (mm)||Standard Deviation|Mean
61113|NCT01195675|Other Pre-specified|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Drug administration until beginning of next sequence/end of trial, up to 48 days|Treated set (TS): All subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment.||participants|||Number
61114|NCT01195675|Other Pre-specified|Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings.|"The placebo corrected change from mean baseline is defined per time point as the difference of the change from baseline for empa or moxifloxacin minus the average change from baseline obtained for the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.~Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms||Standard Deviation|Mean
61208|NCT01195090|Secondary|Changes in High Sensitive C-reactive Protein|fasting high sensitive serum C-reactive protein change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy||mg/dl||Standard Error|Least Squares Mean
61115|NCT01195675|Other Pre-specified|Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing.|"The time-matched change from placebo is defined per time point as the difference of the ECG measurement following administration of empa or moxifloxacin minus the average of the measurements obtained following the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.~Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms||Standard Deviation|Mean
61116|NCT01195675|Primary|Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg.~Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Deviation|Mean
61117|NCT01195675|Secondary|Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.~For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen.~Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
61118|NCT01195675|Secondary|Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.~For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen.~Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
61119|NCT01195675|Secondary|Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings~Note, the means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
61120|NCT01195675|Secondary|Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg.~Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Deviation|Mean
61121|NCT01195675|Secondary|Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg.~Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
61122|NCT01195675|Primary|Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg.~Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.||ms|Participants|Standard Error|Mean
61123|NCT01195662|Secondary|Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue|Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator.|Baseline (Day 1), Week 12|N= All randomized participants who received double-blind medication and had non-missing Week (t) values. Week 12 includes participants with orthostatic hypotension during Week 12 visit window. Data after rescue included.||Percent of Participants|||Number
61124|NCT01195662|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue|12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing.|Baseline, Week 12|N= All randomized participants who received double-blind medication. Data after rescue included.||participants|||Number
61125|NCT01195662|Secondary|Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue|Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3*ULN); ALP (>1.5*ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug.|Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days|N=All randomized participants who received at least 1 dose of study medication. n=number of participants treated with double blind study medication with at least one non-missing post-baseline value. Data after rescue included.||participants|||Number
61126|NCT01195662|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue|Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5*ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure.|Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days|N=All randomized participants who received at least one dose of double-blind medication. n=all treated participants who had non-missing Baseline and on-study measurement. Data after rescue included.||participants|||Number
61127|NCT01195662|Secondary|Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue|Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events.|Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event|Randomized participants who received double-blind study medication in the double-blind period.||participants|||Number
61128|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue was included.||mg/dL||Standard Error|Mean
61129|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)|Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer’s and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement (Week 12 LOCF). Data after rescue excluded from analyses.||mmHg||Standard Error|Mean
61130|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants|Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant’s dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses||mmHg||Standard Error|Mean
61153|NCT01195584|Primary|Postoperative Complications in the BMI Groups During Post Operative Hospitalization.|Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.|at hospital discharge|Analysis per protocol||Events during hospitalization|||Number
61278|NCT01194440|Secondary|Health Assessment Questionnaire Disability Index||12 months||||||
61131|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)|Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer’s and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and Week 12 (LOCF) values. Data after rescue excluded from analyses.||mmHg||Standard Error|Mean
61132|NCT01195662|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue included.||Percent of Hemoglobin||Standard Error|Mean
61133|NCT01195662|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants|Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant’s dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses||mmHg||Standard Error|Mean
61134|NCT01195636|Secondary|Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF)|"Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated.~This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF).~The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."||units on a scale||95% Confidence Interval|Least Squares Mean
61135|NCT01195636|Secondary|Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)|"Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed.~This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)).~The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."||units on a scale||Standard Deviation|Mean
61136|NCT01195636|Secondary|Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment||3 Weeks|||participants|||Number
61137|NCT01195636|Secondary|Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||participants|||Number
61138|NCT01195636|Secondary|Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||participants|||Number
61154|NCT01195467|Secondary|Change From Baseline of CNS Toxicity as Measured by Hospital Anxiety and Depression (HADS) Score (Baseline vs Week 12)|To assess the change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12)|baseline to week 12||||||
61139|NCT01195636|Secondary|Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo|Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||participants|||Number
61140|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 3|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||units on a scale||95% Confidence Interval|Least Squares Mean
61141|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 2|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|2 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||units on a scale||95% Confidence Interval|Least Squares Mean
61142|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 1|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|1 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."||units on a scale||95% Confidence Interval|Least Squares Mean
61143|NCT01195636|Primary|Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing mean daily pain scores were imputed using last observation carried forward (LOCF).~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."||units on a scale||95% Confidence Interval|Least Squares Mean
61144|NCT01195623|Secondary|Recurrence Rate|number of recurrences in treatment arms but also nature of recurrences|7 years|The number of legs with recurrence of varicose veins in the saphenofemoral junction (SFJ)or saphenopopliteal junction (SPJ)||legs|Participants||Number
61145|NCT01195623|Primary|Rate of Re-do Surgery|number of reoperations (legs) in the two treatment arms|7 years mean|The number of legs has been analyzed, randomized 166 legs in the duplex group and 177 in the no-duplex group||legs|||Number
61146|NCT01195597|Secondary|Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)|Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)||number of participants|||Number
61147|NCT01195597|Primary|Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)|Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)||number of participants|||Number
61148|NCT01195584|Secondary|Days of Hospitalization|Total time of hospitalization.|at hospital discharge|analysis per protocol||Days||Standard Deviation|Mean
61149|NCT01195584|Secondary|Drainage|Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured.|at hospital discharge|analysis per protocol||ml||Standard Deviation|Mean
61150|NCT01195584|Secondary|Number of Spine Segments|Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs.|peri operative|analysis per protocol||spine segments||Standard Deviation|Mean
61151|NCT01195584|Secondary|Blood Loss|Loss of blood during surgical procedure in milliliters.|after surgery|analysis per protocol||ml||Standard Deviation|Mean
61155|NCT01195467|Secondary|Change From Baseline in Adherence From Baseline After 12 Weeks of Raltegravir as Measured by the Adherence Questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|To assess the change from baseline in adherence from baseline after 12 weeks of raltegravir as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|baseline to week 12||||||
61156|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Non-CNS Adverse Events After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 non-CNS adverse events after 12 weeks of raltegravir compared with baseline|baseline to week 12||||||
61157|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Laboratory Parameters (Excluding Lipids) After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 12 weeks of raltegravir compared with baseline|baseline to week 12||||||
61158|NCT01195467|Secondary|Change in Fasting Lipids (Total Cholesterol and Subfractions and Triglycerides) After 4 and 12 Weeks of Raltegravir|To assess the change in fasting lipids (total cholesterol and subfractions and triglycerides) after 4 and 12 weeks of raltegravir|week 4 to week 12||||||
61159|NCT01195467|Secondary|Proportion of Patients With Viral Load < 50 Copies/mL and <400 Copies/ml at Weeks 4 and 12 After Switching to Raltegravir|To assess the proportion of patients with viral load < 50 copies/mL and <400 copies/ml at weeks 4 and 12 after switching to raltegravir|week 4 to week 12||||||
61160|NCT01195467|Secondary|Change From Baseline to Week 12 in CD4+ Count After 12 Weeks of Raltegravir|Change from baseline to week 12 in CD4+ count after 12 weeks of raltegravir having switched from efavirenz-containing therapy|baseline to week 12||||||
61161|NCT01195467|Secondary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment|"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)"|baseline to week 12|||percentage of improvement in sleep score|||Number
61162|NCT01195467|Primary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment|To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)|4 weeks|||percentage improvement in CNS score|||Number
61163|NCT01195415|Secondary|Proportion of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0|Will be reported along with exact binomial 95% confidence intervals. Specific toxicities of all grades will be tabulated and reported.|Up to 4 weeks||||||
61164|NCT01195415|Secondary|Progression Free Survival|Assessed using the Kaplan-Meier method. The 95% confidence interval for this estimate will be computed using the Greenwood’s formula.|3 months||||||
61165|NCT01195415|Secondary|The Number of Participants With an Objective Best Response (CR + PR)|The number of participants with either a complete response (CR) or a partial response (PR) will be calculated. A CR is defined as the disappearance of all target lesions. A PR is defined as at least a 30% decrease in the sum of the diameters of target lesions.|Up to 4 weeks|All treated patients were evaluable.||participants|||Number
61166|NCT01195415|Primary|Percent Decrease From Baseline in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS|Proportion of CD44+CD24+ESA+ cells from needle biopsy were calculated at baseline and at 3 weeks using FACS. The difference between the two time points was calculated.|3 weeks|Of the 25 patients enrolled, only 22 were evaluable for the primary endpoint.||Percent decrease in CD44+/ CD24+/ ESA+|||Number
61167|NCT01195363|Primary|Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.|The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.|Baseline visit to week 24|Per Protocol||participants|||Number
61168|NCT01195272|Secondary|Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments|Benefit:Risk was defined at the participant level. It was considered acceptable if the DAS28 improvement represented at least a moderate European League Against Rheumatism (EULAR) response. The risks were based on the known adverse event (AE) profile of tocilizumab rather than on the actual AEs experienced by each participant|Weeks 12, 24, and 36|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
61169|NCT01195272|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index includes swollen and tender joint counts, acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]), and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS, which includes a 44 swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||score on a scale||Standard Deviation|Mean
61170|NCT01195272|Primary|Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation|Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of positive neutrophils||Standard Deviation|Mean
61171|NCT01195272|Primary|Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake|S. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of positive neutrophils||Standard Deviation|Mean
61172|NCT01195272|Primary|Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||chemiluminescence units * hours||Standard Deviation|Mean
61173|NCT01195272|Primary|Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||chemiluminescence units*hours||Standard Deviation|Mean
61174|NCT01195272|Primary|Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
61175|NCT01195272|Primary|Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
61176|NCT01195272|Primary|Mean Fluorescence Intensity of CD63 on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
61177|NCT01195272|Primary|Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls.|Visits 2, 3 and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
61178|NCT01195272|Primary|Mean Fluorescence Intensity of CD18 on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed at each visit||fluorescence intensity unit||Standard Deviation|Mean
61179|NCT01195272|Primary|Mean Fluorescence Intensity of CD11b on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||fluorescence intensity unit||Standard Deviation|Mean
61180|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of cells staining positive||Standard Deviation|Mean
61181|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|Intent-to-treat (ITT) Population: all participants in the Safety Population who provided follow-up data for neutrophils or at least 1 efficacy variable. n (number) equals (=) number of participants analyzed for the specified parameter at a given visit.||percentage of cells staining positive||Standard Deviation|Mean
61182|NCT01195116|Primary|Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU|It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.|Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average|||units on a scale||Standard Deviation|Mean
61183|NCT01195103|Primary|Percentage of Participants Achieving Sedation Within 4 Minutes|"Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals lethargic response to name spoken in normal tone."|approximately 4 minutes after administration of first bolus of study drug|||percentage of participants|||Number
61211|NCT01195025|Primary|Elimination Half Life for Different Fluids Alone or When Combined|Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.|420 minutes|All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers. Each experiment generated one elimination half-life (In experiment C one for acetated Ringer's and one for starch (HES 6%)).||Minutes|Participants|Inter-Quartile Range|Median
61212|NCT01195025|Secondary|Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.|The investigators will measure a few markers of coagulation (fibrinogen, thrombocytes, D-Dimer, PK-INR, aPTT, and coagulation factor VII) as well as Cystatin C, serum albumine and hemoglobin and how the concentration of these vary with the different dilutions of blood during and after infusion of a colloid and/or a crystalloid solution.|420 minutes||05/2015||||
61213|NCT01195025|Secondary|Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)|"Difference between true hemoglobin B-Hb and measured hemoglobin with pulseoximeter (SpHb)at the end of an infusion in relation to the initial measured values SpHb and B-Hb at the start of the infusion.~Relative difference (%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"|30 min|Only the pure experiments were included in this analysis. The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant.||percentage of relative difference|Participants|Inter-Quartile Range|Median
61214|NCT01195025|Secondary|Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids|"Pulse-oximeter based measurements compared with invasive hemoglobin measurements. All paired in the study.~Accuracy depending on which infusion is selected (Ringer's, Hydroxyethyl starch or a combination of both)."|420 min|The study was analysed per protocol and missing values were not replaced. All pairs of all collected data in one series of experiments. The number of analysed data points for each subject was in experiment A: 26, in experiment B: 32 and in experiment C: 42.||percentage of relative difference|Participants|Inter-Quartile Range|Median
61215|NCT01195025|Primary|Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.|"volume kinetics: mathematical calculation from hemoglobin variations during and after an infusion.~Degree of plasma dilution depending on which solution(s) and how much solution is/are given."|420 minutes|"All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers.~Each experiment generated one distribution volume. (In experiment C one for acetated Ringer's and one for Starch (HES 6%))."||Litre||Inter-Quartile Range|Median
61216|NCT01194999|Primary|Change in OAB Symptoms Post Pubovaginal Sling Operation|Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.|Baseline to final follow-up.|All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy.||participants|||Number
61217|NCT01194973|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
61218|NCT01194973|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline sustained for at least two consecutive measurements obtained at least four weeks apart|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized for each parameter.||Percentage of Participants||95% Confidence Interval|Number
61219|NCT01194973|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61220|NCT01194973|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61221|NCT01194973|Secondary|Proportion of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
61236|NCT01194830|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.||Participants|||Number
61237|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.||Participants|||Number
61222|NCT01194973|Secondary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
61223|NCT01194973|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
61224|NCT01194973|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61225|NCT01194973|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61226|NCT01194973|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61227|NCT01194973|Primary|Proportion of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through 26 weeks of treatment was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
61228|NCT01194973|Primary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
61229|NCT01194908|Secondary|To Determine the Safety of Tamoxifen in Combination With Decitabine and LBH589||Patients will undergo an evaluation for extent of disease 8 weeks from starting study drugs and every 8 weeks (2 cycles) while on study.|No data were analyzed due to trial termination.|||||
61230|NCT01194908|Primary|To Determine the Maximum Tolerated Dose of Decitabine and LBH589 Given in Combination in Patients With Metastatic or Locally Advanced Metastatic Breast Cancers||Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.|No data were analyzed due to trial termination.|||||
61231|NCT01194869|Secondary|Clinical Response Rate (Complete Pathologic Response Rate After Surgery)|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen during follow-up. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|Up to 2 years after definitive surgery|||participants|||Number
61232|NCT01194869|Secondary|Clinical Response Rate During Follow-up (Disease Recurrence)|Response will be assessed according to World Health Organization criteria with progressive disease (PD) defined as a 25% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.|Up to 2 years after definitive surgery|||participants|||Number
61233|NCT01194869|Primary|Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|At the time of surgery, after 24 weeks of preoperative treatment|||participants|||Number
61234|NCT01194830|Secondary|Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks||baseline, 24 weeks|Meal Tolerance Test, observed cases data set (MTT-OC) includes all randomized patients who participated in the MTT sub-study. Patients required to have both baseline and on-treatment results.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
61235|NCT01194830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks||baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
61239|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
61240|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
61241|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
61242|NCT01194830|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
61243|NCT01194154|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|24 months|The Safety Analysis Set (SAF) included all participants who received at least one dose of study medication. Analysis for SAF was performed according to the study medication actually received (as treated population). Number of participants analyzed=participants evaluable for this measure.||percentage of participants|||Number
61244|NCT01194154|Secondary|Change From Baseline in Serum Cystatin C Concentration at Month 24|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.||mg/L||Standard Deviation|Mean
61245|NCT01194154|Secondary|Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24|UACR is defined as the ratio: milligram of albumin per gram of creatinine. The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Number of Participants Analyzed (N) = number of participants evaluable and available with valid data for this outcome measure. Here, n=number of participants evaluable for each category.||mg/g||Standard Deviation|Mean
61246|NCT01194154|Secondary|Change From Baseline in Serum Creatinine Concentration at Month 24|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.||mcmol/L||Standard Deviation|Mean
61247|NCT01194154|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24|Creatinine clearance was calculated according to the Cockcroft and Gault Formula. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (>=) 90 mL/min. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.||mL/min||Standard Deviation|Mean
61248|NCT01194154|Secondary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)|The eGFR value calculated using the CKD-EPI equation. The formula used is based on age, sex, ethnicity, and serum creatinine and eGFR values are calculated as follows: GFR in mL/min per 1.73 m^2 = 141 x min (SerumCr/k; 1)^a x max(SerumCr/k; 1)^(-1.209) x 0.993^age x F x B, where k=0.7 for female (else=0.9); a=-0.329 for female (else=-0.411), F=1.018 for female (else=1), B=1.159 for black (else=1), min/max=minimum/maximum of listed values. The Yearly Reduction Rate (mL/min/1.73m^2 / Year) is defined as –365.25 x Beta, where Beta is the slope parameter derived for each participant separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
61249|NCT01194154|Primary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)|The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m^2) = 175 x Serum Cr^-1.154 x age^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m^2 / Year) is defined as –365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
61250|NCT01194089|Secondary|Numeric Pain Score|Upon arrival in the PACU and at least every 30 minutes thereafter while in the PACU, the subject was asked to report pain using a numerical pain score for current pain at rest from 0 (representing no pain) to 10 (representing the worst imaginable pain).|on admission, 30 minutes, 60 minutes, at discharge|Not all participants completed the pain scale at every time point. The participants analyzed per arm (nicotine, normal) at each time point were: on admission (40, 45); 30 minutes (40, 47); 60 minutes (34, 40); at discharge (39, 44),||units on a scale||Inter-Quartile Range|Median
61251|NCT01194089|Secondary|Number of Participants Who Needed to Use Antiemetic Medication in the PACU|Rescue antiemetic therapy was 0.625 mg droperidol. Recalcitrant postoperative pain, nausea and vomiting (PONV) was treated per discretion of the supervising anesthesiologist.|24 hours postoperatively.|||participants|||Number
61252|NCT01194089|Primary|Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively|Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.|During PACU stay (approximately 94 minutes after operation), 24 hours after operation|||mg||Inter-Quartile Range|Median
61253|NCT01194674|Secondary|Change in Retino-vascular Leakage, as Seen on Fluorescein Angiography (FA), at 4 Weeks vs. Baseline|"Retino-vascular leakage was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. For cases in which a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume."|Baseline and 4 weeks||||||
61254|NCT01194674|Primary|Number of Non-ocular Adverse Events|The number of adverse events that were not eye-related was calculated.|24 weeks|||Adverse Events|||Number
61255|NCT01194674|Primary|Number of Ocular Adverse Events|The number of eye-related adverse events was calculated.|24 weeks|||Adverse Events|||Number
61256|NCT01194674|Primary|Number of Severe Adverse Events||24 weeks|||Adverse Events|||Number
61257|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 12 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 12 Weeks||||||
61258|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 4 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 4 weeks||||||
61259|NCT01194674|Secondary|Number of Participants Achieving Macular or Complete Posterior Vitreous Detachment (PVT) at 4 Weeks||Baseline and 4 weeks||||||
61260|NCT01194674|Secondary|Change in Central Macular Thickness, as Measured by Optical Coherence Tomography (OCT), at 4 Weeks vs. Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 4 weeks||||||
61261|NCT01194674|Primary|Number of Adverse Events||24 weeks|||Adverse Events|||Number
61262|NCT01194531|Primary|Implantation Rate|Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.|Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.|Patients who reached embryo transfer were included in this analysis.||percentage of implantation per group|||Number
61263|NCT01194479|Primary|Norepinephrine (pg/mL)|Norepinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.||pg/mL||Standard Error|Mean
61264|NCT01194479|Primary|Epinephrine (pg/mL)|Epinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.||pg/mL||Standard Error|Mean
61265|NCT01194479|Secondary|Blood Glucose Levels (Average)|Blood glucose levels will be checked every 5 minutes during the 120 minute study session in order to maintain blood glucose levels in the normal and hypoglycemic range. Presented is the average of the collected values.|Up to 120 minutes|Subjects are pooled across randomized conditions in their respective study arms and reported overall.||mg/dL||Standard Deviation|Mean
61266|NCT01194479|Primary|Glucagon (pg/mL)|Glucagon levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages.|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.||pg/mL||Standard Error|Mean
61267|NCT01194453|Secondary|Response Rate||6 weeks|||percentage|||Number
61268|NCT01194453|Primary|Progression Free Survival (PFS)||36months|||day||95% Confidence Interval|Median
61269|NCT01194440|Secondary|Number of Patients Who Discontinue or Change Aromatase Inhibitory (AI) Therapy||12 months||||||
61270|NCT01194440|Secondary|Inflammatory Markers (ESR, CRP, IL-1, IL-6, IL-8)||12 months||||||
61271|NCT01194440|Secondary|Bone Turn Over Markers (Serum-C Telopeptide, Bone-specific Alkaline Phosphatase, Osteocalcin and Urinary N-telopeptide)||12 months||||||
61272|NCT01194440|Secondary|Mineral Density as Assessed by DEXA Scan||12 months||||||
61273|NCT01194440|Secondary|Plasma Estrogen Concentrations||12 months||||||
61274|NCT01194440|Secondary|Hot Flash Frequency||12 months||||||
61279|NCT01194440|Primary|Frequency of Women With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)|The primary hypothesis of the study is that given zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS as compared to patients receiving letrozole alone. The number of women experiencing AIMSS in this study is compared to the results from a prior published study of women receiving letrozole alone.|12 months|||Participants|||Count of Participants
61280|NCT01194427|Primary|Changes in Markers of Proliferation Prior to and After Study Drug Administration|To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.|Baseline and 14 days|Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report.|||||
61281|NCT01194414|Secondary|Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97||Week 97|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Here, 'n' indicates number of subjects in the safety population tested by screening assay at any time point.||percentage of participants|||Number
61282|NCT01194414|Secondary|Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97||Baseline, Week 97|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
61283|NCT01194414|Secondary|Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25||Baseline, Week 25|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
61284|NCT01194414|Secondary|Time to Maximum Serum Concentration (Tmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||hour (hr)||Full Range|Median
61285|NCT01194414|Secondary|Maximum Serum Concentration (Cmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||mcg/mL||Standard Deviation|Mean
61286|NCT01194414|Secondary|Minimum Serum Concentration (Cmin) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.||micrgram/milliliter (mcg/mL)||Standard Deviation|Mean
61287|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment||Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.||μg*hr/mL||Standard Deviation|Mean
61288|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion||Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
61289|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug.||percentage of participants|||Number
61290|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.|Baseline, Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.||percentage of participants|||Number
61298|NCT01194414|Primary|Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments||Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.||percentage of participants|||Number
61291|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. If ESR=0 then ESR=1 is substituted into the DAS28 calculation to enable a non-missing DAS28 score. Here, number of participants analyzed is the participants for whom parameter was collected.||percentage of participants|||Number
61292|NCT01194414|Secondary|Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97|ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.|Week 97|Re-Randomized Intent-to-Treat Population (ITT Population) included all participants who completed double blind period and were re-randomized at Week 24, received at least 1 dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.||percentage of participants|||Number
61293|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|24 Weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations.||Percentage of participants|||Number
61294|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.|Baseline, 24 Weeks|Participants from the Per Protocol Population (all randomized participants who received study drug and had no major protocol violations) with data available for analysis. No imputation of missing scores will be made other than for missing baseline scores, for which last score prior to defined protocol baseline time window will be carried forward.||Percentage of participants|||Number
61295|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.|Week 24|Participants from the Per Protocol Population (randomized participants who received study drug and had no major protocol violations) with data available for analysis. Missing SJC and TJC will be imputed using the last post-baseline value for the patient (LOCF). No imputation for missing ESR or patient’s global assessment of disease activity.||Percentage of participants|||Number
61296|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.||Percentage of participants|||Number
61297|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.||Percentage of participants|||Number
61299|NCT01194414|Primary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.||Percentage of participants||95% Confidence Interval|Number
61300|NCT01194297|Secondary|Medically-attended Wheezing|Wheezing that triggers a visit for medical care|42 days|Total N||participants|||Number
61301|NCT01194297|Primary|Humoral Immunogenicity|Hemagglutinin specific antibody, as measured by hemagglutination inhibition|28-42 days||||||
61302|NCT01194258|Secondary|Mean Daily PPG Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (insulin lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Period 1 and Period 2 with evaluable PPG excursion data.||mg/dL||Standard Deviation|Mean
61303|NCT01194258|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both cohorts).|Baseline, Week 12 and Week 24|All participants who completed both Period 1 and Period 2 with evaluable body weight data.||pounds||Standard Deviation|Mean
61304|NCT01194258|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and <56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2.||Events per participant per month|||Number
61305|NCT01194258|Secondary|Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants in Treatment Period 1 or Treatment Period 2 who received at least 1 dose of study drug and had evaluable postprandial blood glucose data.||Percentage of participants|||Number
61306|NCT01194258|Secondary|Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring|Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable insulin dosing data.||units of Insulin||Standard Deviation|Mean
61307|NCT01194258|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period|Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable HbA1C data.||percentage of HbA1C||Standard Deviation|Mean
61349|NCT01193868|Primary|Percentage of Tumor Shrinkage as a Continuous Variable|Response is reported as a continuous variable, as % change in tumor size from baseline. Pearson and Spearman correlation coefficients will be used. Reported with 95% two-sided confidence intervals.|6 weeks|Study terminated early with low accrual leading to insufficient data for analysis.|||||
64441|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Terminal Differentiation Response to Therapy.|Bone marrow evidence of terminal differentiation will be correlated with response criteria|Day 0,42,84||03/2013||||
61308|NCT01194245|Secondary|Mean Daily Postprandial Glucose (PPG) Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose (PPG) excursion data.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
61309|NCT01194245|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable body weight data.||pounds (lbs)||Standard Deviation|Mean
61310|NCT01194245|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period|Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable hemoglobin A1C data.||percentage of hemoglobin A1C||Standard Deviation|Mean
61311|NCT01194245|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2.||events per participant per month|||Number
61312|NCT01194245|Secondary|Percentage of Participants Meeting Glucose Targets|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose data.||percentage of participants|||Number
61313|NCT01194245|Secondary|Mean Daily Insulin Dose|Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable insulin dose data.||units (U)||Standard Deviation|Mean
61314|NCT01194219|Secondary|Number of Participants With a Psoriasis Flare or Rebound During the Placebo Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Weeks 0 to Week 16|Included all participants who were randomized and received at least one dose of Investigational Product.||participants|||Number
61315|NCT01194219|Secondary|Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)||participants|||Number
61316|NCT01194219|Secondary|Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment where loss of PASI-75 was observed (event); or the time between the re-randomization date and the date of the last PASI assessment in the Weeks 32-52 interval prior to addition of protocol-prohibited medication/therapy, or resumption of APR 30 BID, or discontinuation, or Week 52 if no loss (censored).|Week 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or apremilast 30mg BID at Week 32.||Weeks||95% Confidence Interval|Median
61317|NCT01194219|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline at Week 16 From Baseline|"PASI-75 response was the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome Measure #1 for further description.~sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See OCM #2 for further description."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
61318|NCT01194219|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|"The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).~Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
61319|NCT01194219|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant’s skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from “Very Much” (score 3) to “Not at All” or “Not relevant” (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant’s skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if “No,” then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being “A lot,” “A little,” or “Not at all” (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included||units on a scale||Standard Error|Least Squares Mean
61320|NCT01194219|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.||units on a scale||Standard Error|Least Squares Mean
61321|NCT01194219|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|A participant was classified as having at least a 50% improvement in PASI score from baseline, which was equivalent to a percent change from baseline ranging from −100% to −50%. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||Percentage of Participants|||Number
61322|NCT01194219|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|"Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.~PASI score percent change from baseline was calculated as 100* (visit score – baseline score)/baseline score (%)."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included .||percent change||Standard Error|Least Squares Mean
61531|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS) The FAS included all randomized participants.||ratio|||Number
61323|NCT01194219|Secondary|Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16|"BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint” including the fingers), which equates to approximately 1% of total body surface area.~BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA – baseline BSA) / baseline BSA (%)."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.||percent change||Standard Error|Least Squares Mean
61324|NCT01194219|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator factored in areas that have already been cleared (ie, have scores of 0) and did not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.||percentage of participants|||Number
61325|NCT01194219|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
61326|NCT01193920|Secondary|Number of Infants Reporting Serious Adverse Events|Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events|one year after birth|||Number of subjects|||Number
61327|NCT01193920|Secondary|Antibody GMC Per Serotype at Different Time Points in Infants|Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.|Day 4, day 43 and day 91 after birth|Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
61328|NCT01193920|Secondary|Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events|Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.|From day 1 to one year after delivery|Safety set, solicited and unsolicited reactogenicity, maternal subjects||participants|||Number
61329|NCT01193920|Secondary|Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events|Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.|Day 61|Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects||participants|||Number
61330|NCT01193920|Secondary|Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination|Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
61331|NCT01193920|Secondary|The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.|The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.||percentage of subjects||95% Confidence Interval|Number
61332|NCT01193920|Secondary|Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination|Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.|day 31|FAS, secondary, maternal subjects, day 31||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
61333|NCT01193920|Primary|Antibody GMC in Maternal Subjects at Day of Delivery|Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.|Day of delivery|FAS primary, maternal subjects||Concentration (μg/mL)||95% Confidence Interval|Geometric Mean
61383|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 5 - <10kg) N=3||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mL||Standard Deviation|Mean
61334|NCT01193920|Primary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day of delivery|FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery||percentage of subjects||95% Confidence Interval|Number
61335|NCT01193920|Secondary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 31, one month after vaccination|FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31||percentage of subjects||95% Confidence Interval|Number
61336|NCT01193920|Primary|Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.|Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .|Day 61, one month after the second vaccination|FAS - primary, non-pregnant subjects||concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
61337|NCT01193920|Primary|The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.|The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 61, one month after the second vaccination|Full Analysis Set (FAS) – primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61||percentage of subjects||95% Confidence Interval|Number
61338|NCT01193907|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 28 days after vaccination|||percentage of subjects||95% Confidence Interval|Number
61339|NCT01193907|Primary|Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)||At 28 days after vaccination|||GMC||95% Confidence Interval|Mean
61340|NCT01193907|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination|||participants|||Number
61341|NCT01193907|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue|During the 7-day period after vaccination|||participants|||Number
61342|NCT01193868|Secondary|Progression-free Survival|Time from initiation of study drug until death, progression of tumor, or for worsening of tumor that did not meet RECIST 1.1 criteria but that did require discontinuation of therapy, assessed up to 5 years|Baseline up to 5 years|Study terminated early. Analysis not performed due to small numbers.|||||
61343|NCT01193868|Secondary|Correlation of Tumor Shrinkage/Response With Biomarker Expression|Correlate percent change in tumor size at 6 weeks (or at time off study, if therapy is stopped earlier due to tumor progression) with tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers; Tumor % shrinkage with RO4929097 will correlate with pre-therapy tumor expression of Notch pathway members, with expression of stem cell markers, and with changes in these over the first cycle of therapy.|6 weeks|Study terminated early. Analysis not performed due to small numbers.|||||
61344|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Tumor Progression|Tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers used in comparison to tumor progression; and progression evaluated in using international criteria proposed by revised RECIST guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests.|Up to 3 months|Study terminated early with low accrual leading to insufficient data for analysis.|||||
61345|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Response by RECIST Criteria|Wilcoxon rank sum tests will be used.|Up to day 3|Study terminated early. Analysis not performed due to small numbers.|||||
61346|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Epidermal Growth Factor Receptor (EGFR) Activating Mutations|Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Sum Test). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.|||||
61347|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With Versus Without a Particular Host Genotype Polymorphism|Wilcoxon rank sum tests will be used. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests).|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.|||||
61348|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in This Population vs Tumor Bank Population|For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.|||||
61350|NCT01193868|Primary|Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with response per RECIST version 1.1: Complete Response (CR):Disappearance all target lesions. Any pathological lymph nodes with reduction in short axis to <10 mm. Partial Response (PR): At least 30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): At least 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must demonstrate an absolute increase of at least 5 mm. (Note: appearance of 1 or more new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Best response recorded from treatment start until disease progression/recurrence (reference for progressive disease the smallest measurements recorded since treatment started).|Response evaluation every 6 weeks (in addition to baseline scan, confirmatory scans approximately 6-7 (not less than 4) weeks following initial documentation of objective response). Expected follow up to 5 years, actual study period 9/2010 to 4/2014.|Only those participants who have measurable disease present at baseline and received at least one dose of study medication considered evaluable for response with their response classified according to the RECIST definitions stated. Participants who exhibit objective disease progression prior to the end of cycle 1 also considered evaluable.||percentage of participants|||Number
61351|NCT01193686|Secondary|General Anger Level|5-item scale developed for this study. Assesses level of perceived experienced anger in the past month. Possible scores range from 5-35 with higher scores indicating greater levels of anger.|Post- Participation|This measure was only administered to Recipients of Peer Visits.||units on a scale||Full Range|Mean
61352|NCT01193686|Secondary|Patient Activation Measure|Measures participante self-efficacy, knowledge of and engagement in health care. Possible scores range from 13-52 with higher scores indicating greater efficacy/knowledge/engagement.|Post- Participation|This measure was only administered to Recipients of Peer Visitation.||units on a scale||Full Range|Mean
61353|NCT01193686|Secondary|Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)|Measures PTSD symptoms. Possible scores range from 19-95, with higher scores indicating greater symptom severity.|Upon study completion.|||units on a scale||Full Range|Mean
61354|NCT01193686|Secondary|Patient Health Questionnaire-9 (Depression Screen)|9-item depression screen with possible response options ranging from 9-36, with higher numbers indicating greater depression symptom severity.|Upon completion of visits.|||units on a scale||Full Range|Mean
61355|NCT01193686|Primary|Post Traumatic Growth Inventory|Administered only to Peer Visitors, possible range 0-105, with higher scores indicating greater post-traumatic growth. Post-traumatic growth includes emotional changes such as noticing a stronger sense of self, deepened relationships, increased sense of gratitude or appreciation for life, increased spirituality.|Upon completion of study requirements (i.e., visits)|This measure was only administered to Veteran Peer Visitors.||units on a scale||Full Range|Mean
61356|NCT01193660|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant|The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.|6 months|||participants|||Number
61357|NCT01193660|Secondary|Changes in Hand Function|QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61358|NCT01193660|Secondary|Changes in Muscle Strength|Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61359|NCT01193660|Secondary|Changes in Functional Independence in Daily Activities|WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61360|NCT01193660|Primary|Changes in Standardized Gross Motor Function|GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61361|NCT01193660|Secondary|Changes in Functional Performance in Daily Activities|Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.|Baseline -1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61384|NCT01193348|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
61362|NCT01193660|Secondary|Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism|"18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that 1 refers to INCREASED areas, -1, DECREASED areas and 0, just NO CHANGE."|Baseline - 2 weeks|Intention to treat||units on a scale|||Number
61363|NCT01193660|Secondary|Changes in Brain MRI|Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.|Baseline - 6 months|||units on a scale||Standard Error|Mean
61364|NCT01193660|Secondary|Changes in Motor Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61365|NCT01193660|Secondary|Changes in Cognitive Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61366|NCT01193660|Primary|Changes in Motor Performance|GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat||units on a scale||Standard Error|Mean
61367|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
61368|NCT01193582|Secondary|Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.|Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
61369|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
61370|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3|Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
61371|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
64442|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Cytotoxicity.|Cytotoxicity will be correlated with clinical response criteria|Day 0, 42, 84||03/2013||||
61372|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2|Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
61373|NCT01193582|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||Fold rise||95% Confidence Interval|Geometric Mean
61374|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1|Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
61375|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group|Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|Baseline|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
61376|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar|Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after last dose in each group|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
61377|NCT01193556|Secondary|Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level||1-2 weeks post-operatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
61378|NCT01193556|Primary|Post-operative Pain|The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.|10 days immediately following surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
61379|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort ≥40kg) N=5||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.||micrograms/mL||Standard Deviation|Mean
61380|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 30 - <40kg) N=1||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data. N=0 in the maintenance phase because the patient changed to ≥40kg body weight category||micrograms/mL||Standard Deviation|Mean
61381|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 20 - <30kg)||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mL||Standard Deviation|Mean
61382|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 10 - <20kg) N=7||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mL||Standard Deviation|Mean
61631|NCT01192152|Secondary|Metformin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng*hr/mL||Standard Deviation|Mean
61385|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with eGFR Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61386|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61387|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61388|NCT01193348|Secondary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
61389|NCT01193348|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
61390|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61391|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61392|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through 26 weeks of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.||Percentage of Participants||95% Confidence Interval|Number
61393|NCT01193348|Primary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.||Percentage of Participants||95% Confidence Interval|Number
61394|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
61488|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
61395|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
61396|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
61397|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.||percentage of participants||95% Confidence Interval|Number
61398|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.||percentage of participants||95% Confidence Interval|Number
61399|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||titer||95% Confidence Interval|Geometric Mean
61400|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.||titer||95% Confidence Interval|Geometric Mean
61401|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
61402|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|Before the toddler dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
61532|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS): The FAS included all randomized participants.||ratio|||Number
61403|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.||titer||95% Confidence Interval|Geometric Mean
61404|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
61405|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
61406|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
61407|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
61408|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
61409|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
61489|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Seven Days Post-Surgery 7 Days|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
61410|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
61411|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.||mcg/mL||95% Confidence Interval|Geometric Mean
61412|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
61413|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.||percentage of participants||95% Confidence Interval|Number
61414|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2, 3 and toddler dose), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
61415|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
61416|NCT01193335|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose|GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws.|Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
61490|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
61417|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1-year follow-up after toddler dose to 2-year follow-up after toddler dose|Safety population for 2-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.||percentage of participants|||Number
61418|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 month after toddler dose up to 1-year follow-up|Safety population for 1-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.||percentage of participants|||Number
61419|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Toddler dose up to 1 Month after toddler dose|Safety population for toddler dose included all participants who received 13vPnC toddler dose.||percentage of participants|||Number
61420|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 Month after Dose 3 of the infant series up to toddler dose|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.||percentage of participants|||Number
61421|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Dose 1 up to 1 month after Dose 3 (infant series)|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.||percentage of participants|||Number
61422|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
61423|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
61431|NCT01193335|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
61424|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
61425|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received 13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.||percentage of participants|||Number
61426|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
61427|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
61428|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
61429|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.||percentage of participants|||Number
61430|NCT01193335|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after the infant series|Evaluable infant immunogenicity population. Here ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
61432|NCT01193283|Primary|The Primary Objective is to Evaluate the Safety and Activity Profile of Cyclophosphamide and Cyclosporine in Severe Aplastic Anemia (SAA) Patients.|"The objective of this phase I/II study is to assess the safety of cyclophosphamide 120 mg/kg + low dose cyclosporine (100 – 200 micrograms per liter) as initial therapy in subjects with treatment-naïve SAA. We hypothesize that cyclophosphamide/ cyclosporine has activity in SAA with higher complete response rates with few instances of relapse and clonal evolution and could be a viable alternative treatment.~The study will evaluate the safety and activity profile of cyclophosphamide/ cyclosporine in SAA. The safety endpoint will be toxicity profile after 6 months of treatment. The efficacy endpoint is complete response at 6 months."|6 months|||participants|||Number
61433|NCT01193218|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days|Treated patients||participants|||Number
61434|NCT01193218|Secondary|Change From Baseline in FPG|Change from baseline in FPG after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)||mg/dL||Standard Error|Least Squares Mean
61435|NCT01193218|Secondary|Occurrence of Treat to Target Efficacy Response|Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)||percentage of participants||95% Confidence Interval|Number
61436|NCT01193218|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment.|The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.|baseline and 12 weeks|Full analysis set (FAS)||percentage of HbA1c||Standard Error|Least Squares Mean
61437|NCT01193153|Secondary|Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
61438|NCT01193153|Secondary|Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
61439|NCT01193153|Secondary|Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
61440|NCT01193153|Secondary|Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
61485|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
61533|NCT01193101|Secondary|Number of Participants Who Achieved Successful BP Control|BP control is defined as BP < 140/90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.||Participants|||Number
61441|NCT01193153|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
61442|NCT01193153|Secondary|Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
61443|NCT01193153|Secondary|Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Deviation|Mean
61444|NCT01193153|Secondary|Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a scale||Standard Deviation|Mean
61445|NCT01193153|Secondary|Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed.|Baseline and Endpoint (Week 64/LOCF) in DB period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values.'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||participants|||Number
61446|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a Scale||Standard Error|Least Squares Mean
61447|NCT01193153|Secondary|Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. Last Observation Carried Forward (LOCF) method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.||Units on a Scale||Standard Deviation|Mean
73805|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Monocytes|Change from baseline|Baseline and 52 week after|||percentage of Monocytes||Standard Deviation|Mean
61448|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Week 64 of double blind relapse prevention period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.||Units on a scale||Standard Error|Least Squares Mean
61449|NCT01193153|Primary|Double-blind: Percentage of Participants Who Experienced Relapse|Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.|Day 1 up to Month 15 of double blind relapse prevention period|Double-blind(DB) Intent-to-Treat(ITT) analysis set included all randomly assigned participants who received at least 1 injection of DB study medication.‘n’ signifies participants who were evaluable for each specified category,for each arm.||percentage of participants|||Number
61450|NCT01193127|Secondary|Use of Pain Medications After Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects||participants|||Number
61451|NCT01193127|Secondary|Use of Pain Medications at Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|All randomized subjects||participants|||Number
61452|NCT01193127|Secondary|Postoperative Use of Ophthalmic Anti-inflammatory Medications|Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects||participants|||Number
61453|NCT01193127|Secondary|Ocular Pain VAS Score After Day 0|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.|43 days|Subjects with data at time point.||mm||Standard Deviation|Mean
61454|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 30|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|30 days|Subjects with data at time point.||cells||Standard Deviation|Mean
61455|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 14|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|14 days|Subjects with data at time point.||cells||Standard Deviation|Mean
61456|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 7|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Seven days|Subjects with data at time point.||cells||Standard Deviation|Mean
61457|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 2|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two days|Subjects with data at time point.||cells||Standard Deviation|Mean
61458|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 1|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|One day|Subjects with data at time point.||cells||Standard Deviation|Mean
61459|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two hours|Subjects with data at time point.||cells||Standard Deviation|Mean
61486|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
62146|NCT01188603|Primary|Flibanserin: Tmax,ss|Median of the tmax,ss of Flibanserin|8 days|All patients with values for the time from dosing to the maximum measured concentration of flibanserin in plasma after single dose at steady state (tmax,ss)||h||Full Range|Median
61460|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.||participants|||Number
61461|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.||participants|||Number
61462|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.||participants|||Number
61463|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.||participants|||Number
61464|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.||participants|||Number
61465|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.||participants|||Number
61466|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.||participants|||Number
61467|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
61468|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
61469|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
61470|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
61471|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
61472|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery|"TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
61487|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
61473|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.||units on a scale||Standard Deviation|Mean
61474|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 30|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|30 days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
61475|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 14|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|14 days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
61476|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 7|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Seven days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
61477|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 2|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Two days|Subjects with scores at time point.||Log score||Standard Deviation|Mean
61478|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 1|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|One day|Subjects with scores at time point.||Log score||Standard Deviation|Mean
61479|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Baseline|Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Baseline|Subjects with scores at time point.||Log score||Standard Deviation|Mean
61480|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
61481|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
61482|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
61483|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
61484|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
61491|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
61492|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
61493|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
61494|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
61495|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
61496|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
61497|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
61498|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
61499|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 6 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
61500|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
61501|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
61502|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
61503|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
64443|NCT01165996|Secondary|Proportion of Patients With Pharmacodynamic Evidence of Drug Effect.|Evidence of pharmacodynamic effect will be correlated with clinical response criteria.|Day 0, 42, 84||03/2013||||
61504|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
61505|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
61506|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
61507|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 2 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
61508|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia 30 Days Post-Surgery /Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.||participants|||Number
61509|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
61510|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
61511|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
61512|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
61513|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
61514|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
61515|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, 30 Days Post-Surgery/ Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|Subjects with scores at time point.||participants|||Number
61516|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.||participants|||Number
65996|NCT01150461|Primary|Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year|||Percentage change in fibrotic myocardium||Standard Deviation|Mean
61517|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.||participants|||Number
61518|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.||participants|||Number
61519|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.||participants|||Number
61520|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.||participants|||Number
61521|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.||participants|||Number
61522|NCT01193127|Primary|Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively|For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.|through 12 hours post-surgery|Subjects with postoperative VAS scores.||units on a scale||Standard Deviation|Mean
61523|NCT01193127|Primary|Pupil Diameter (mm) During Surgery|Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.|During surgery (immediately prior to surgical incision to wound closure)|Subjects with interpretable video recordings obtained during surgery.||mm||Standard Deviation|Mean
61524|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||units on a scale||Standard Deviation|Mean
61525|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||units on a scale||Standard Deviation|Mean
61526|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||units on a scale||Standard Deviation|Mean
61527|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||percent days of substance use||Standard Deviation|Mean
61528|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||percent days of substance use||Standard Deviation|Mean
61529|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.||percent days of substance use||Standard Deviation|Mean
61530|NCT01193101|Secondary|Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8|From week 8 to week 9, participants entered a single-blind placebo withdrawal period to assess the effect of LCZ696 on blood pressure following its discontinuation. Participants, who were randomized to the LCZ696 treatment groups, were discontinued from CLCZ696 at the end of week 8 and all 4 treatment groups received single-blind placebo for 1 week post week 8. A positive change from week 8 to week 9 indicates worsening.|8 weeks, 9 weeks|Only participants from the full analysis, who had values at both week 8 and week 9, were included in the analysis. The FAS included all randomized participants.||mmHg||Standard Deviation|Mean
61534|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.||Participants|||Number
61535|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.||Participants|||Number
61536|NCT01193101|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Mean ambulatory pulse pressure is the difference in maSBP and maDBP (maSBP - maDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
61537|NCT01193101|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Mean sitting pulse pressure is the difference in msSBP and msDBP (msSBP - msDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
61538|NCT01193101|Secondary|Change From Baseline in Nighttime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
61539|NCT01193101|Secondary|Change From Baseline in Daytime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
61540|NCT01193101|Secondary|Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
61541|NCT01193101|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
61542|NCT01193101|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.||mmHg||Standard Error|Least Squares Mean
61543|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge.|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then prostaglandin and leukotriene concentrations were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As this same approach in a parallel study was unfruitful, these data were not pursued, and results are not presented.|||||
61544|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf)|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 23 hours had elapsed, BALf were collected, then the concentrations of IL-5, IL-13, and TARC were determined from BALf collected after 23 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 23 hours post-allergen challenge|As concentrations of cytokines were below the lower limit of quantitation this analysis was not performed, and results are not presented.|||||
61545|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-23 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was plan to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As IL-23 levels were too low to detect, this analysis was not performed and results are not presented.|||||
61546|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TSLP were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As TSLP levels were too low to detect, this analysis was not performed and results are not presented.|||||
61547|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61548|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61549|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61550|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61551|NCT01193049|Secondary|Change in Vibration Response Imaging (VRI) After Metacholine Exposure|One hour before treatment with prednisone/placebo, participants inhaled for 2 minutes a nebulised solution of metacholine (0.13 ml/min); then one hour after prednisone/placebo treatment were challenged with allergens. From 1 to 7 hours after allergen challenge, ventilatory heterogeneity was assessed by Vibration Response Imaging (VRI) by monitoring the following: inspiration/expiration (I/E) amplitude ratio, I/E duration ratio, synchrony duration, and quantitative lung data.|From 1 to 7 hours post-allergen challenge|As all VRI results showed no allergen or treatment-related signals these results are not presented.|||||
61552|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61553|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61554|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61555|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants||Fold Change||90% Confidence Interval|Geometric Mean
61556|NCT01192542|Primary|Binocular Visual Acuity|Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results|Post lens insertion (baseline)|Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol.||LogMAR||Standard Error|Least Squares Mean
61557|NCT01192542|Secondary|Bulbar Redness of Grade 3 or Above|Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.||Subject Eyes|Participants||Number
73806|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Lymphocytes|Change from baseline|Baseline and 52 week after|||percentage of Lymphocytes||Standard Deviation|Mean
61558|NCT01192542|Secondary|Limbal Redness of Grade 3 or Above|Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.||Subject Eyes|Participants||Number
61559|NCT01192542|Primary|Monocular Visual Acuity Assessment|Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.|Post lens insertion (baseline)|Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study.||logMAR|Participants|Standard Error|Least Squares Mean
61560|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance people walk in feet over 6 minutes|6 months post baseline|Numbers may differ due to missing data||feet||Standard Deviation|Mean
61561|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance in feet that people walk over 6 minutes.|10 weeks post-baseline|Numbers may differ due to missing data||feet||Standard Deviation|Mean
61562|NCT01192516|Secondary|Physical Function- Six Minute Walk|Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes|Baseline|Numbers may vary due to missing data||feet||Standard Deviation|Mean
61563|NCT01192516|Primary|Pain- WOMAC|This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.|6 months post baseline|Numbers may vary due to missing data||units on a scale||Standard Deviation|Mean
61564|NCT01192516|Primary|Pain- WOMAC|This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.|10 weeks post-baseline|Sample numbers may differ due to missing data||units on a scale||Standard Deviation|Mean
61565|NCT01192516|Primary|Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.|Baseline|||units on a scale||Standard Deviation|Mean
61566|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.|6 months post-baseline|Sample numbers may vary due to missing data||units on a scale||Standard Deviation|Mean
61567|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|10 weeks post-baseline|Sample numbers may differ due to missing data||units on a scale||Standard Deviation|Mean
61568|NCT01192516|Primary|Fatigue- Brief Fatigue Inventory (BFI)|This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|Baseline|||units on a scale||Standard Deviation|Mean
61569|NCT01192412|Secondary|Serious Maternal Complications Measured up to 6 Weeks Postpartum|"Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications:~Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or~End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion)"|6 weeks|||participants|||Number
61570|NCT01192412|Primary|Pregnancy Loss or NICU Admission for Greater Than 48 Hours|Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records.|6 weeks|||participants|||Number
61571|NCT01192347|Secondary|Maximum Daily Dose of Anagrelide Hydrochloride||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||mg/day||Standard Deviation|Mean
61572|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
61573|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
61574|NCT01192347|Secondary|Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
61575|NCT01192347|Secondary|Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
61576|NCT01192347|Secondary|Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
61577|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61578|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61579|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61580|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61589|NCT01192295|Secondary|Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets|Plasma concentration data were characterized for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients. Plasma samples were collected after the first dose on day 1 (one sample 2 to 4 hours after the dose and 1 sample 4 to 6 hours after the dose with approximately 2 hours between the samples), and immediately predose (morning or evening dose) and 2 to 4 hours after that dose at visit 2 and/or visit 3; a total of 4 to 6 samples were collected.|Day 1, week 2, and week 4||||||
61630|NCT01192152|Primary|Metformin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61581|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61582|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61583|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61584|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61585|NCT01192347|Secondary|Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||participants|||Number
61586|NCT01192347|Secondary|Percentage of Subjects With Anagrelide Hydrochloride Starting Doses||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.||percentage of subjects|||Number
61587|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61588|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.||percentage of subjects||95% Confidence Interval|Number
61626|NCT01192152|Secondary|Metformin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61590|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
61591|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
61592|NCT01192295|Secondary|Parent/ Caregiver-Assessed Global Impression of Change (PGIC)|The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group.|Baseline to week 4 or early discontinuation|The safety population was the group of patients who received at least 1 dose of study drug during the study.||participants|||Number
61593|NCT01192295|Secondary|Use of Supplemental Pain Medication|Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||participants|||Number
61594|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years|Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked “no pain” and the opposite end marked as “pain as bad as it could be.” The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the “no pain” end to the patient’s mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
61595|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged 6 to < 12 Years|Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with “no hurt” at the far left and “hurts worst” at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.||units on a scale||Standard Deviation|Mean
61596|NCT01192295|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.|Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).|The safety population was the group of patients who received at least 1 dose of study drug during the study.||participants|||Number
61597|NCT01192282|Primary|Commonest HPV Genotypes Isolated by HIV Status|10 commonest types of HPV isolated according to HIV status|18 months|||Participants|||Number
61598|NCT01192282|Primary|Number of HPV Genotypes Isolated by HIV Status|Number of HPV Genotypes isolated according to HIV Status|Up to 18 months|119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable.||participants|||Number
61599|NCT01192282|Primary|HPV DNA and Pap Smear Results|Relationship between HPV DNA Positivity and Pap Smear Results|18 Months|Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done.||Participants|||Number
61600|NCT01192282|Primary|HPV DNA and HIV Status|HPV DNA Positivity and HIV Status|18 Months|Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients.||participants|||Number
61601|NCT01192204|Secondary|Treatment Changes in Loss of Heterozygosity Events|Laboratory experiments will be conducted to assess the effects of gel treatment on pre and post loss of heterozygosity (LOH) events at loci associated with tumor suppressor genes.|Before and after the 3 month treatment duration|||LOH events||Standard Error|Mean
61627|NCT01192152|Secondary|Metformin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||percentage of fluctuation||Standard Deviation|Mean
61628|NCT01192152|Secondary|Metformin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61602|NCT01192204|Secondary|Changes in Lesional Sizes|The remaining oral dysplasia lesion will be inspected at each follow up appointment (every 10-14 days). Biopsies will be immediately conducted on patients with any indication of malignant transformation including indurated, rolled borders, nonhealing ulcers, etc. Accordingly, these patients will withdraw from the trial. Participants will also be monitored for any changes consistent with contact mucositis e.g. soreness and erythema at application site. Clinical photographs were taken for the patients records. Pre treatment and post treatment photographs, with a ruler in place, were used for accurate pre and post treatment size measurement. NOTE: if treatment is beneficial, lesional size will decrease which will be reflected as a negative number.|pretreatment and posttreatment (3 months treatment duration)|||mm^2||Standard Deviation|Mean
61603|NCT01192204|Primary|Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment|A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME).|Before and after the 3 month treatment.|The population evaluated were as previously described i.e. 22 participants in the BRB gel cohort and 18 participants in the placebo gel cohort.||unit on histologic grade scale||Standard Error|Mean
61604|NCT01192191|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.|Baseline (Week -2), Week 12, Week 24, and Week 52|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
61605|NCT01192191|Secondary|Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Beats/Minute||Standard Deviation|Mean
61606|NCT01192191|Secondary|Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
61607|NCT01192191|Secondary|Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)|24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)|The Urine Cortisol Population: all participants in the ITT Population for whom a urine sample was obtained and whose urine sample was not considered to have confounding factors that could affect the interpretation of the results. Only those participants with post-Baseline data available at the indicated time points were analyzed.||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
61608|NCT01192191|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
61609|NCT01192191|Secondary|Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
73807|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Basophils|Change from baseline|Baseline and 52 week after|||percentage of Basophils||Standard Deviation|Mean
61610|NCT01192191|Secondary|Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
61611|NCT01192191|Secondary|Number of Participants With Pneumonia During the Treatment Period|Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population||Participants|||Number
61612|NCT01192191|Primary|Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population||Participants|||Number
61613|NCT01192191|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period||Participants|||Number
61614|NCT01192178|Secondary|Mean Percentage of Rescue-free Days|A rescue-free day was defined as a day during the Peak Viral Period on which no puffs of rescue medication were recorded. Percentage of rescue-free days was defined as the number of days during the Peak Viral Period on which no puffs of rescue medication were recorded, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.||Percentage of days||Standard Deviation|Mean
61615|NCT01192178|Secondary|Mean Percentage of Symptom-free Days|A symptom-free day was defined as a day during the Peak Viral Period on which the asthma symptom score was zero. The daily asthma symptom score (measured during the day and the previous night) was reported on a 6-point scale (ranging from 0=no symptoms to 5=severe symptoms). Percentage of symptom-free days was defined as the number of days during the Peak Viral Period on which the asthma symptom score=0, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.||Percentage of days||Standard Deviation|Mean
61616|NCT01192178|Secondary|Mean Percentage of Episode-free (EF) Days|An EF day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, school absenteeism due to asthma, or morning peak expiratory flow (measure of maximum airflow) <80% of baseline. Percentage of EF days=No. of EF days divided by No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.||Percentage of days||Standard Error|Mean
61629|NCT01192152|Secondary|Metformin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61617|NCT01192178|Secondary|Mean Percentage of Asthma-control Days|An asthma-control day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than double-blind study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, or school absenteeism due to asthma. The percentage of asthma-control days = the number (No.) of asthma-control days divided by the No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.||Percentage of days||Standard Error|Mean
61618|NCT01192178|Secondary|Number of Asthma Exacerbations Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection During the Peak Viral Period|Each participant (with assistance from the parent/legal guardian as needed) was instructed to keep an electronic diary (eDiary) with record of daily URTS symptoms that included: runny nose, sneezing, nasal congestion, and sore throat. Based on the best-described aggregate URTS during the previous 24 hours, participants rated symptoms as: 0 = Not present; 1 = Mild, clearly present; 2 = Moderately severe, uncomfortable; and 3 = Severe, interfering with sleep or activity. Mucus samples were collected and analyzed for RVwhen the eDiary alerted for moderate/severe URTS.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who reported >=1 exacerbation were analyzed. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.||Number of asthma exacerbations|||Number
61619|NCT01192178|Secondary|Mean Duration of Worsening Asthma Symptoms Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection|A worsening asthma day is one on which any of the following occurred: rescue albuterol use above baseline, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study medication, asthma symptom scores >=3, nighttime awakenings, unscheduled health care visits, or missed school due to asthma. The duration of worsening asthma is the number of consecutive worsening asthma days after the date of a URTS score of 2 (moderate) or 3 (severe) or collection of a mucus sample containing RV (whichever occurred first). Each span of consecutive days is a participant interval.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants with relevant data defining a worsening asthma day during the peak viral period and with moderate or severe URTS or a confirmed RV infection were analyzed.||Days per participant interval||Standard Error|Mean
61620|NCT01192178|Secondary|Mean Asthma Symptom Scores, as an Indicator of Severity, Associated With the Presence of Moderate or Severe Upper Respiratory Tract Symptoms (URTS) or a Confirmed Rhinovirus (RV) Infection at Baseline and During the Peak Viral Period|Participants recorded their asthma symptom score over the previous 24 hours (during the day and the previous night) using the following 6-point scale: 0=No symptoms; 1=Symptoms for 1 short period; 2=Symptoms for >=2 short periods; 3=Symptoms for most of the day/previous night that did not affect normal daily activities; 4=Symptoms for most of the day/previous night that affected normal daily activities; 5=Symptoms so severe that participant could not perform normal daily activities. The Baseline mean asthma symptom score was calculated as the average score over 7 days prior to Week 1, Visit 2.|Baseline (Week 1) and Peak Viral Period ([period during which the greatest number of viral infections is expected] from 30 August 2010 through the end of the treatment period [up to Week 16])|ITT Population. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.||Scores on a scale||Standard Deviation|Mean
61621|NCT01192178|Primary|Total Number of Asthma Exacerbations Reported During the Treatment Period|An asthma exacerbation was defined as deterioration of asthma that required the use of outpatient oral/parenteral corticosteroids (tablets, suspensions, or injection) or an urgent care, hospitalization, or emergency room (ER) visit due to asthma that required oral/parenteral corticosteroids. Two exacerbations (out of a total of 51) were excluded: (1) one exacerbation occurred within 7 days of the resolution of an earlier one, and, per protocol, was combined with the previous exacerbation; and (2) one exacerbation occurred post treatment.|From Baseline (Week 1) until the end of treatment (up to Week 16)|Intent-to-Treat (ITT) Population: all participants randomized to treatment. Only those participants who reported >=1 exacerbation were analyzed.||Number of asthma exacerbations|||Number
61622|NCT01192152|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities considered clinically significant and/or reported as an AE by the investigator.|From Day 1 of Period 1 to Day 3 of Period 2 for participants in Treatment Sequence BA and Day 5 of Period 3 for participants in Treatment Sequence ABC|All subjects who received at least one dose of study medication.||participants|||Number
61623|NCT01192152|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on morning of Day 1/Period 1 through study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|All subjects who received at least one dose of study medication.||participants|||Number
61624|NCT01192152|Secondary|Metformin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||hour||Standard Deviation|Mean
61625|NCT01192152|Secondary|Metformin AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C was administered only during Period 3, & this measure was analyzed for Periods 1 and 2.||ratio||Standard Deviation|Mean
61632|NCT01192152|Secondary|Metformin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61633|NCT01192152|Primary|Metformin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded due to the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61634|NCT01192152|Secondary|5-hydroxy Saxagliptin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||hour||Standard Deviation|Mean
61635|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)/AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ratio||Standard Deviation|Mean
61636|NCT01192152|Secondary|5-hydroxy Saxagliptin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61637|NCT01192152|Secondary|5-hydroxy Saxagliptin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||percentage of fluctuation||Standard Deviation|Mean
61638|NCT01192152|Secondary|5-hydroxy Saxagliptin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61639|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61640|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61641|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng*hr/mL||Standard Deviation|Mean
61642|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61643|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61644|NCT01192152|Secondary|Saxagliptin Time to Achieve the Observed Maximum Plasma Concentration (Tmax)||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.||hour||Standard Deviation|Mean
61645|NCT01192152|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ratio||Standard Deviation|Mean
61646|NCT01192152|Secondary|Saxagliptin Terminal Half-life (T1/2)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61647|NCT01192152|Secondary|Saxagliptin Degree of Fluctuation Over the Dosing Interval (Fluctuation %)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||percentage of fluctuation||Standard Deviation|Mean
61648|NCT01192152|Secondary|Saxagliptin Average Plasma Concentration Over the Dosing Period (Cavg)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61649|NCT01192152|Secondary|Saxagliptin Trough (Predose) Plasma Concentration (Cmin)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61650|NCT01192152|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1 & 2: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 & 48 hrs post-dosing. Period 3: predosing on Days 2 & 3; predosing, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hrs postdosing on Day 4|All treated participants not discontinuing prior to end of study.||ng/mL||Standard Deviation|Mean
61651|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC[0-tau])|Dosing interval = 24 hours.|Period 3: pre-dosing on Days 2 and 3; pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours post-dosing on Day 4.|All treated participants not discontinuing prior to end of study.||ng*hr/mL||Standard Deviation|Mean
61652|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61653|NCT01192152|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.||ng*hr/mL||Standard Deviation|Mean
61654|NCT01192139|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and Electrocardiogram (ECG) Abnormalities|Abnormalities considered by the investigator to be clinically significant and/or reported as an AE.|From Day 1 of Period 1 through Day 3 of Period 3 (study discharge)|Safety Population||Participants|||Number
61655|NCT01192139|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on Day 1/Period 1 through study discharge Day 3/Period 3. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|Safety Population = all participants who received any study drug.||Participants|||Number
61656|NCT01192139|Secondary|Metformin Fraction of AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC(0-inf) was due to the inability to estimate Kel for some of the subjects).||ratio||Standard Deviation|Mean
61657|NCT01192139|Secondary|Metformin Tmax||Periods 1, 2, and 3 (before dosing, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
61658|NCT01192139|Secondary|Metformin T1/2|terminal half life; calculated as ln(2)/Kel|Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for T1/2 was due to the inability to estimate Kel for some of the subjects).||hours||Standard Deviation|Mean
61659|NCT01192139|Primary|Metformin Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng/mL||Standard Deviation|Mean
61660|NCT01192139|Secondary|Metformin AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
61661|NCT01192139|Primary|Metformin AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC[0-inf] was due to the inability to estimate potassium chloride for some participants)||ng*hr/mL||Standard Deviation|Mean
61662|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)/AUC(0-inf)||Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants||ratio||Standard Deviation|Mean
61663|NCT01192139|Secondary|Active Metabolite BMS-510849 Tmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
61664|NCT01192139|Secondary|Active Metabolite BMS-510849 T1/2|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
61665|NCT01192139|Secondary|Active Metabolite BMS-510849 Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng/mL||Standard Deviation|Mean
61666|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
61667|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
61668|NCT01192139|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ratio||Standard Deviation|Mean
61669|NCT01192139|Secondary|Time to Achieve the Observed Maximum Saxagliptin Plasma Concentration (Tmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
61670|NCT01192139|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng/mL||Standard Deviation|Mean
61671|NCT01192139|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
61672|NCT01192139|Secondary|Saxagliptin Terminal Half-life (T1/2)|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||hours||Standard Deviation|Mean
61673|NCT01192139|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants||ng*hr/mL||Standard Deviation|Mean
61674|NCT01192126|Primary|Slit Lamp Examination > Grade 2|Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.|All study visits from screening through 2 week follow-up|All Dispensed Eyes||Eyes|Participants||Number
61675|NCT01192126|Primary|Visual Acuity|Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.|Dispensing Visit and 1 week follow-up|All Eligible Dispensed Eyes||LogMAR|Participants|Standard Deviation|Mean
61676|NCT01192022|Secondary|Time to Intraoperative Hemostasis at Target Bleeding Site|The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.|10 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.||minutes||Full Range|Median
61677|NCT01192022|Secondary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes|3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 5 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.||percentage of participants||95% Confidence Interval|Number
61678|NCT01192022|Primary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes|3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 3 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.||percentage of participants||95% Confidence Interval|Number
61679|NCT01191944|Secondary|Levodopa (L-Dopa) Dose Change During the Study|Although the number of patients who began the study with concomitant L-dopa supplementation and required a change in dosage was not analysed for this study, the change from baseline in L-dopa dose is presented.|18 weeks|FAS. Only patients with concomitant L-Dopa treatment at baseline.||mg||Standard Deviation|Mean
61680|NCT01191944|Secondary|Levodopa (L-Dopa) Introduction During the Study|Number of patients without concomitant L-Dopa treatment at baseline which required L-Dopa supplementation during the study.|18 weeks|FAS. Only patients without concomitant L-Dopa treatment at baseline.||Participants|||Number
61681|NCT01191944|Secondary|Change From Baseline in UPDRS III Score Separately at Week 18|UPDRS Part III (motor examination) ranges from 0 to 108. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)||Units on a scale||Standard Error|Least Squares Mean
61682|NCT01191944|Other Pre-specified|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks|ESS is a patient-report scale with 8 items rating how likely one is to fall asleep during passive and inconsequential situations such as watching television, more active situations such as sitting and talking to someone, or consequential situations such as sitting in a car, while stopped for a few minutes in traffic. The likelihood of dozing off is rated from 0 points (no chance) to 3 points (high chance). The overall rating scale is scored from 0 (no daytime sleep) to 24 (worst daytime sleep).|Baseline and week 18|Observed cases (OC). Only patients with ESS assessment at baseline and at 18 weeks were analyzed.||Units on a scale||Standard Deviation|Mean
61683|NCT01191944|Secondary|Change From Baseline in UPDRS II Score Separately at Week 18|UPDRS Part II (activities of daily living) ranges from 0 to 52. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)||Units on a scale||Standard Error|Least Squares Mean
62147|NCT01188603|Primary|Flibanserin: Cmax,ss|Geometric mean of the Cmax,ss of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
61684|NCT01191944|Secondary|Responder in UPDRS Parts II+III Score at Week 18|Responders were defined as patients with at least a 20 percent improvement of UPDRS II+III score relative to baseline. UPDRS II+III ranges 0-160 scores from best to worst and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108).|Baseline and week 18|FAS (LOCF)||Participants|||Number
61685|NCT01191944|Secondary|Patient Global Impressions of Improvement (PGI-I) Responder at Week 18|The PGI-I scale is a patient-rated instrument which was used to measure the improvement of a patients PD symptoms throughout the study. Ranging from 1 point=very much better to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much better) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF)||Participants|||Number
61686|NCT01191944|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder at Week 18|CGI-I was used to assess the overall status of Parkinsons disease (PD) after interviewing the patient about the various aspects of the PD and after evaluating adverse events and concomitant treatments. Ranging from 1 point=very much improved to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much improved) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF). Only patients with on-treatment CGI-I evaluation were analyzed.||Participants|||Number
61687|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18|Duration of on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
61688|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18|Duration of on-time without Dyskinesia or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
61689|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18|Duration on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
61690|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without Dyskinesia at Week 18|Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
61691|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
61692|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18|Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
61693|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
61694|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage of on-time||Standard Error|Least Squares Mean
61695|NCT01191944|Secondary|Responder in Percentage Off-time During Waking Hours at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Participants|||Number
61696|NCT01191944|Secondary|Change From Baseline in Duration of Off-time During Waking Hours at Week 18|Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||hours||Standard Error|Least Squares Mean
61697|NCT01191944|Secondary|Change From Baseline in Percentage Off-time During Waking Hours at Week 18|Percentage off-time during waking hours based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced Parkinsons Disease (PD). Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.||Percentage off-time||Standard Error|Least Squares Mean
61698|NCT01191944|Primary|Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|Full analysis set (FAS) with last observation carried forward (LOCF). FAS is defined as all randomised patients which received at least one dose of study drug and provided any post baseline efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
61699|NCT01191827|Primary|Neuronal Response During Sensory Gating|Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.|Immediate|||% BOLD signal||Standard Deviation|Mean
61700|NCT01191788|Secondary|Mental Health Functioning as Measured by SF-12 MCS.|The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.|3 Months Post Treatment|||SF-12 score||Standard Deviation|Mean
61701|NCT01191788|Primary|Depressive Symptoms as Measured by the Beck Depression Inventory II|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.|3 Months Post Treatment|||BDI-II score||Standard Deviation|Mean
61702|NCT01191762|Primary|Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate|This outcome measure documented the effect of intestinal phosphate-binding on [PTH]. Fractional change was calculated as ([PTH]post - [PTH]pre)/[PTH]pre, where 'pre' and 'post' referred respectively to baseline [PTH] (before treatment) and [PTH] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.|4 weeks|||percentage of baseline [PTH]||Standard Error|Mean
61703|NCT01191736|Secondary|The Proportion of Subjects Who Assessed the Responsiveness of the Victim (Manikin) as Judged by Expert Raters|The proportion of the subjects who assessed the responsiveness of the victim (manikin) as judged by expert raters|60 minutes after intervention and two months after intervention|||Proportion of Participants||95% Confidence Interval|Mean
61704|NCT01191736|Primary|Median Compression Depth (mm)|Assessment of resuscitation skills using a Laerdal Resusci Annie recording manikin and Laerdal PC Skill Reporting software|60 minutes after intervention or two months after intervention|Per protocol||millimeters||Inter-Quartile Range|Median
61705|NCT01191723|Secondary|Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours|The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.|baseline, 30 minutes, and 2 hours|Patients with data available at required time point were included in the analysis population.||beats per minute (bpm)||Standard Deviation|Mean
61706|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
61707|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
61708|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
61709|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
61710|NCT01191476|Secondary|Time to Orientation|Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth).|Every minute after anesthesia was stopped until orientation occurred|||Minutes||Standard Deviation|Mean
61711|NCT01191476|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred.|Every minute after anesthesia was stopped until extubation occurred|Measurement||Minutes||Standard Deviation|Mean
61712|NCT01191476|Secondary|Time to Eye Opening|Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred.|Every minute after anesthesia was stopped until the subjects' eyes opened|||Minutes||Standard Deviation|Mean
61713|NCT01191476|Secondary|Time to Loss of Consciousness|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction.|Up to 10 minutes|||seconds||Standard Deviation|Mean
61714|NCT01191476|Primary|Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane|"[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane];~[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe];~[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].~The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused."|Anesthetic Duration between 1 to 3 Hours|The full analysis set was used for the determination of cost of anesthesia.||Yuan||Standard Deviation|Mean
61715|NCT01191411|Primary|Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.|To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.|1 year|Overall, out of 1593 patients assigned to FIT outreach, 648 were screened; out of 479 assigned to colonoscopy outreach, 118 were screened; and out of 3898 assigned to usual care, 471 were screened.||percentage of participants|||Number
61716|NCT01191398|Secondary|Monitoring of Adverse Events During Study Administration|Subjects will be monitored for episodes of apnea, laryngospasm, vomiting, oxygen desaturation(<92%), and changes in heart rate and blood pressure. The time frame will include the time the study medication is administered until at least 30 minutes post Ketamine administration.|1 hour|||adverse events|||Number
61717|NCT01191398|Primary|Difference in Salivary Flow Rate (ml/Min) Between Study Groups|Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)|30 minutes|||ml/min||Standard Deviation|Mean
61718|NCT01191320|Primary|Change in HbA1C|The change in HbA1c from Baseline to 3 Months for each treatment arm|3 months|ITT population||Ratio||Standard Deviation|Mean
61719|NCT01191268|Secondary|Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
61720|NCT01191268|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 4 weeks after last dose|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
61732|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||picogram per milliliter (pcg/mL)||Inter-Quartile Range|Median
61721|NCT01191268|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
61722|NCT01191268|Secondary|Rate of Self-reported Hypoglycemic Events up to 52 Weeks|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
61723|NCT01191268|Secondary|Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.||participants|||Number
61724|NCT01191268|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||events|||Number
61725|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
61726|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
61727|NCT01191268|Secondary|Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated pulse rate was measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Deviation|Mean
61728|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
61729|NCT01191268|Secondary|Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.||milliliters of mercury (mmHg)||Standard Deviation|Mean
61730|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
61731|NCT01191268|Secondary|Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data.||picomole per liter||Standard Deviation|Mean
61755|NCT01191242|Primary|(R)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
61733|NCT01191268|Secondary|Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data.||units per liter (U/L)||Standard Deviation|Mean
61734|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter (U/L)||Inter-Quartile Range|Median
61735|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
61736|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
61737|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)|"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate."|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
61738|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
61739|NCT01191268|Secondary|Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
61740|NCT01191268|Secondary|Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data.||kilograms (kg)||Standard Deviation|Mean
61756|NCT01191242|Primary|(S)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
61741|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
61742|NCT01191268|Secondary|Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)|Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.|Baseline and 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||units||Standard Deviation|Mean
61743|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose|Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
61744|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMPG data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)]||Standard Error|Least Squares Mean
61745|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia|The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
61746|NCT01191268|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
61747|NCT01191268|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
61748|NCT01191268|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
61749|NCT01191255|Secondary|ESA Analysis|Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)|52 weeks|||Units/Day||Full Range|Median
61750|NCT01191255|Secondary|IV Iron Analysis|Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)|52 weeks|||mg/day||Full Range|Median
61751|NCT01191255|Secondary|Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)||52 weeks|Full Analysis Population (LOCF)||% Saturation||Standard Deviation|Mean
61752|NCT01191255|Secondary|Change in Mean Serum Ferritin From Baseline to Week 52||52 weeks|Full Analysis Population (LOCF)||ng/mL||Standard Deviation|Mean
61753|NCT01191255|Primary|Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)|Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.|4 weeks|Full Analysis Population (LOCF)||mg/dL||Standard Deviation|Mean
61754|NCT01191242|Primary|(R)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21|||ng/mL||Standard Deviation|Mean
61774|NCT01191086|Primary|Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations||Open label treatment of up to 62 weeks|The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study.||participants|||Number
61775|NCT01190891|Secondary|Global Rating of Change|The GROC questionnaire is an instrument that measures overall changes in the quality of life of the subject. The use of a GROC is a common, feasible, and useful method for assessing outcome, and has been shown to be a valid measurement of change in patient status in other pain populations. A change in score of three rating points has been established as a clinically significant in the patients perception of quality of life. The GROC has 15 possible choices, with 0 being equal to no change and -1 to -7 indicating a negative change and +1 to +7 indicating a positive change.|1 year|||units on a scale||95% Confidence Interval|Mean
61776|NCT01190891|Primary|Shoulder Pain and Disability Index|The SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability), with higher scores indicating greater pain and disability. It is responsive to change and accurately discriminates between patients who are improving or worsening. It has high test-retest reliability and internal consistency. The minimal detectable change (MDC) is 18 and the minimally clinically important difference (MCID) is between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.|1 year|||units on a scale||95% Confidence Interval|Mean
61777|NCT01190878|Primary|Ocular Inflammation|"Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells."|15 days|Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.||participants|||Number
61778|NCT01190865|Secondary|Determination of the Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.|The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM).|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|Probit analysis was utilized to determine the time in days to 50% correct identification (ID50) of the implanted male DNA 17 loci in female volunteers, with regard to three DNA profile types, including partial DNA profile, > 50% DNA profile, and full (or complete) DNA profile. The analysis was performed using SAS® PROC PROBIT||days||95% Confidence Interval|Median
61779|NCT01190865|Primary|The Percentage of Participants With Persistence of the Y Chromosome in Growth Arrested, Allogeneic, Male-donor Keratinocytes and Fibroblasts When Applied to the Surface of Acute Excisional Wounds in Healthy Female Volunteers|The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM).|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|Cohorts of 3 subjects were examined weekly for the presence of the full set of 17 Y-STR loci (AmpFISTRTM.kit).||percentage of participants|||Number
61780|NCT01190839|Secondary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD]before or at Week 104 were considered to have clinical recurrence.|Baseline up to Week 104|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.||percentage of participants|||Number
61781|NCT01190839|Secondary|Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76|Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned one of the treatment.||percentage of participants|||Number
61782|NCT01190839|Primary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD] before or at Week 76 were considered to have clinical recurrence.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.||percentage of participants|||Number
61783|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|||letters||Standard Deviation|Mean
73808|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Eosinophils|Change from baseline|Baseline and 52 week after|||percentage of Eosinophils||Standard Deviation|Mean
61784|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.||participants|||Number
61785|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.||letters||Standard Deviation|Mean
61786|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 26 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.||participants|||Number
61787|NCT01190813|Secondary|Mean Systemic Adverse Events||Enrollment through 26 weeks|||events||Standard Deviation|Mean
61788|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61789|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61790|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61791|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61792|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61793|NCT01190813|Secondary|Mean Parent Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment|||units on a scale||Standard Deviation|Mean
61794|NCT01190813|Secondary|Mean Child Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61795|NCT01190813|Secondary|Mean Child Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61796|NCT01190813|Secondary|Mean Child Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61797|NCT01190813|Secondary|Mean Child Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61798|NCT01190813|Secondary|Mean Child Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment|||units on a scale||Standard Deviation|Mean
61799|NCT01190813|Secondary|Mean Child Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment|||units on a scale||Standard Deviation|Mean
61800|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||letters||Standard Deviation|Mean
61801|NCT01190813|Primary|Mean Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.~Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.||letters||Standard Deviation|Mean
61802|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||participants|||Number
61803|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||letters||Standard Deviation|Mean
61804|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 18 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 18 weeks after enrollment, adjusted for baseline acuity.|18 weeks after enrollment|||participants|||Number
61805|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 26 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|||letters||Standard Deviation|Mean
61806|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|||participants|||Number
61807|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 16 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 16 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment|||letters||Standard Deviation|Mean
61808|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 16 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment|||participants|||Number
61809|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 10 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment|||letters||Standard Deviation|Mean
61810|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 10 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment|||participants|||Number
61811|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 4 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity.|4 weeks after enrollment|||letters||Standard Deviation|Mean
61812|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 4 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|4 weeks after enrollment|||participants|||Number
61813|NCT01190813|Secondary|Amblyopia Resolution at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|26 weeks after enrollment|||participants|||Number
61814|NCT01190813|Secondary|Amblyopia Resolution at 18 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|18 weeks after enrollment|||participants|||Number
61815|NCT01190813|Secondary|Amblyopia Resolution at 16 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|16 weeks after enrollment|||participants|||Number
61816|NCT01190813|Secondary|Amblyopia Resolution at 10 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|10 weeks after enrollment|||participants|||Number
61817|NCT01190813|Secondary|Amblyopia Resolutionat 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|4 weeks after enrollment|||participants|||Number
61818|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|26 weeks after enrollment|||participants|||Number
61819|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|16 weeks after enrollment|||participants|||Number
61820|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|10 weeks after enrollment|||participants|||Number
61821|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|4 weeks after enrollment|||participants|||Number
61822|NCT01190813|Secondary|Mean Amblyopic Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment|||letters||Standard Deviation|Mean
61823|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity at 18 Weeks||18 weeks after enrollment|||participants|||Number
61824|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|18 weeks after enrollment|The analysis followed the intent-to-treat principle. For missing primary outcome visits (±1 wk), data from a visit 14-27 wks after randomization were used, if available.Multiple imputation(Monte Carlo Markov Chain method) was used for missing 18-wk VA outcomes based on treatment group, baseline VA, and VA scores from completed follow-up visits||participants|||Number
61825|NCT01190813|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.~Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.||participants|||Number
61826|NCT01190566|Secondary|Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography||Baseline, post-1st chemotherapy|||unitless||Standard Deviation|Mean
61827|NCT01190566|Secondary|Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy|Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.|Baseline, post-1st chemotherapy|Of the 48 participants, 13 participants did not undergo magnetic resonance spectroscopy examinations due to workflow problem. We included the available data from 35 participants.||unitless||Standard Deviation|Mean
61828|NCT01190566|Secondary|Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)||Baseline, post-1st chemotherapy|||unitless||Standard Deviation|Mean
61829|NCT01190566|Secondary|Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)||Baseline, post-1st chemotherapy|||min-1||Standard Deviation|Mean
61830|NCT01190566|Secondary|Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)||Baseline, post-1st chemotherapy|||min-1||Standard Deviation|Mean
61831|NCT01190566|Secondary|Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)|Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.|Baseline, post-1st chemotherapy|||% of voxels||Standard Deviation|Mean
61832|NCT01190566|Secondary|Tumor Volume|Tumor volume measured on 3-dimensional magnetic resonance imaging|Baseline, post-1st chemotherapy|||cm3||Standard Deviation|Mean
61833|NCT01190566|Secondary|Tumor Size|Maximal tumor diameter measured on magnetic resonance imaging|baseline, completion of 1st cycle of chemotherapy|||cm||Standard Deviation|Mean
61834|NCT01190566|Primary|Patholocial Response to Chemotherapy|Pathological complete response (pCR) or non-pCR|Post-operation|||participants|||Number
61835|NCT01190527|Secondary|The Number of Participants That Experience Lung Toxicity and Esophagitis|The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.|2 years|||participants|||Number
61836|NCT01190527|Secondary|Percentage of Patients Alive at 2 Years|Overall survival of all patients will be estimated|2 years|||percentage of patients||95% Confidence Interval|Number
61837|NCT01190527|Secondary|Number of Patients That Were Able to Receive Dose Escalation|The number of patients for which dose escalation was possible will be reported.|2 Years|||participants|||Number
61838|NCT01190527|Primary|2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)|Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.|2 years|||percentage of patients||95% Confidence Interval|Number
61839|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Mean
61840|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Mean
61841|NCT01190514|Secondary|Terminal Elimination Half-life (t 1/2)|Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.||hours||Standard Deviation|Mean
61842|NCT01190514|Primary|Maximum Plasma Concentration (Cmax)|Cmax measured as nanograms divided by milliliters (ng/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Mean
61843|NCT01190514|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.||hours||Full Range|Median
61844|NCT01190514|Primary|Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Mean
61845|NCT01190436|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.|Baseline up to Week 12|ITT population included all participants who received at least 1 dose of study drug.||participants|||Number
61846|NCT01190436|Secondary|Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12|The change in total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 minus total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at baseline, respectively.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||mg/dL||Standard Deviation|Mean
61847|NCT01190436|Primary|Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12||Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
61848|NCT01190436|Secondary|Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12|The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||mg/dL||Standard Deviation|Mean
61849|NCT01190436|Secondary|Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12|Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
61850|NCT01190436|Primary|Mean Change From Baseline in Heart Rate at Week 12|The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||beats per minute (bpm)||Standard Deviation|Mean
61851|NCT01190436|Primary|Percentage of Participants With Response to Study Drug|Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
61852|NCT01190436|Primary|Percentage of Participants With Controlled BP|Controlled BP was defined as BP less than 130/80 mmHg.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
61853|NCT01190436|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12|The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.|Baseline, Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.||mmHg||Standard Deviation|Mean
61854|NCT01190436|Secondary|Mean Change From Baseline in HbA1c at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Week 12 was calculated as HbA1c at Week 12 minus HbA1c at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.||Percent HbA1c||Standard Deviation|Mean
61855|NCT01190436|Secondary|Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.||percentage of participants|||Number
61856|NCT01190306|Primary|Change in Corneal Curvature.||6 Months|The CXL-001 study was completed but data analysis was not done. Prior to data analysis, the sponsor, Topcon, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.|||||
61857|NCT01190306|Primary|Changes in Corneal Curvature||6MO||||||
61858|NCT01190267|Primary|Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 26 weeks|All participants who received at least one dose of extension study medication||participants|||Number
61859|NCT01190267|Primary|Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a “treatment-emergent” AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period.|Up to 30 weeks|All participants who received at least one dose of extension study medication||participants|||Number
61860|NCT01190254|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q overall score score must be available for a participant.||score on a scale||Standard Deviation|Mean
61861|NCT01190254|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used a last-observation-carried-forward (LOCF) approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q total score must be available for a participant.||score on a scale||Standard Deviation|Mean
61862|NCT01190254|Secondary|Change From Baseline in Children’s Global Assessment Scale (CGAS) Score at Day 56|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 56; improvement in functioning is represented by positive values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGAS score must be available for a participant.||score on a scale||Standard Deviation|Mean
61863|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study|CGI-I response was defined as the occurrence of a CGI-I score of 1 (very much improved) or 2 (much improved). CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. The Kaplan-Meier estimate reports the cumulative percentage of participants with CGI-I response from first drug intake up to approximately Day 58.|Baseline up to approximately Day 58|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||cumulative % of participants w/ Response|||Number
61864|NCT01190254|Secondary|CGI-I Responders|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at the last available assessment of the study for that participant (i.e., endpoint). CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||participants|||Number
61865|NCT01190254|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Day 56|CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included an on-treatment Day 56 value of the CGI-I score must be available for a participant.||score on a scale||Standard Deviation|Mean
61866|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study|A total PANSS 30% response was defined as a reduction from baseline of at least 30% in the PANSS Total score. The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The Kaplan-Meier estimate reports the cumulative percentage of participants with total PANSS 30% response from first drug intake up to approximately Day 59.|Baseline up to approximately Day 59|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||cumulative % of participants w/ Response|||Number
61867|NCT01190254|Secondary|Total PANSS 30% Responders|A Total PANSS 30% responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS Total score at the last available assessment of the study for that participant (i.e., endpoint). The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).||participants|||Number
61868|NCT01190254|Secondary|Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder anxiety/depression factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder anxiety/depression factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
61869|NCT01190254|Secondary|Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder hostility/excitement factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder hostility/excitement factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
61870|NCT01190254|Secondary|Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder disorganized thoughts factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder disorganized thoughts factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
61871|NCT01190254|Secondary|Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder negative symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder negative symptoms factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
61872|NCT01190254|Secondary|Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56|This measure reports results for the 8 items of the Marder positive symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items (Marder et al. J Clin Psychiatry 1997;58(12):538-46). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder positive symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder positive symptoms factor score must be available for a participant.||score on a scale||Standard Deviation|Mean
61892|NCT01190215|Secondary|Number of Days With Any Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
73809|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Platelet Count|Change from baseline|Baseline and 52 week after|||*10000/μl||Standard Deviation|Mean
61873|NCT01190254|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS general psychopathology subscale score must be available for a participant.||score on a scale||Standard Deviation|Mean
61874|NCT01190254|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56|This measure reports results for the combined positive subscale (7 items) and negative subscale (7 items) of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each of the total 14 items in the combined positive and negative subscales, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive and negative subscale scores combined for each participant was calculated as the sum of the rating assigned to each of the 14 combined subscale items, and ranged from 14 to 98 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive/negative subscale scores combined must be available for a participant.||score on a scale||Standard Deviation|Mean
61875|NCT01190254|Secondary|Change From Baseline in PANSS Negative Subscale Score at Day 56|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS negative subscale score must be available for a participant.||score on a scale||Standard Deviation|Mean
61876|NCT01190254|Secondary|Change From Baseline in PANSS Positive Subscale Score at Day 56|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive subscale score must be available for a participant.||score on a scale||Standard Deviation|Mean
61877|NCT01190254|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56|Change from baseline in CGI-S score at Day 56 is the Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGI-S score must be available for a participant.||score on a scale||Standard Deviation|Mean
61878|NCT01190254|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 56 value of PANSS Total Score must be available for a participant.||score on a scale||Standard Deviation|Mean
61893|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).~Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61879|NCT01190215|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Ratio||95% Confidence Interval|Geometric Mean
61880|NCT01190215|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
61881|NCT01190215|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
61882|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61883|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61884|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Special Interest.|Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61885|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).|Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61886|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61887|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61888|NCT01190215|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination."|Within 28 days (Day 0 – Day 27) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61889|NCT01190215|Secondary|Number of Days With Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.~Grade 3 symptom = general symptom that prevented normal activity.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
61890|NCT01190215|Secondary|Number of Days With Any Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
61891|NCT01190215|Secondary|Number of Days With Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain and swelling.~Grade 3 redness/swelling = redness/swelling above 50 millimetres.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Days||Inter-Quartile Range|Median
73810|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Leucocytes|Change from baseline|Baseline and 52 week after|||/microliter(mcl)||Standard Deviation|Mean
61894|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
61895|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.~Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
61896|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.~Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
61897|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||titre||95% Confidence Interval|Geometric Mean
61898|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||titre||95% Confidence Interval|Geometric Mean
61899|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Ratio||95% Confidence Interval|Geometric Mean
61900|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Ratio||95% Confidence Interval|Geometric Mean
61901|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
61902|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
61903|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
62148|NCT01188603|Primary|Flibanserin: Cmax (Peak Concentration)|Geometric mean of the Cmax of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
61904|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
61905|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Subjects|||Number
61906|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
61907|NCT01190215|Primary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.~Day 28 data was presented only for the Fluarix Group."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Subjects|||Number
61908|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.||Titres||95% Confidence Interval|Geometric Mean
61909|NCT01190215|Primary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~Day 28 data were presented only for the Fluarix Group.~Titres were expressed as geometric mean antibody titre."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Titres||95% Confidence Interval|Geometric Mean
61910|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.||Titres||95% Confidence Interval|Geometric Mean
61911|NCT01190150|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Treatment-emergent AEs are summarized by total participants with TEAEs, participants with serious TEAEs, participants with TEAEs deemed by the investigator to be related to treatment, and participants who experienced TEAEs that caused permanent discontinuation from the study.|Day 1 up to week 4|The Safety Population consisted of all randomized participants who received at least one dose of tranexamic acid.||participants|||Number
61912|NCT01190150|Primary|Elimination Half-life (t ½)|Apparent first-order terminal elimination half life|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||hours||Standard Deviation|Mean
61913|NCT01190150|Primary|The Ratio of AUC0-t to AUCinf|Comparison of AUC0-t to AUCinf by creating a ratio.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.||ratio of AUC0-t / AUCinf||Standard Deviation|Mean
61914|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|Dose-normalized AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.||μg*h/mL||Standard Deviation|Mean
61915|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.||μg*h/mL||Standard Deviation|Mean
61916|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg*h/mL||Standard Deviation|Mean
61917|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg*h/mL||Standard Deviation|Mean
61918|NCT01190150|Primary|Time to Maximum Concentration Level (Tmax)|Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||hours||Standard Deviation|Mean
61919|NCT01190150|Primary|Dose-normalized Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified and normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg/mL||Standard Deviation|Mean
61920|NCT01190150|Primary|Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.||μg/mL||Standard Deviation|Mean
61921|NCT01190124|Secondary|Adverse Drug Reactions|Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.|Week 48|||participants|||Number
61922|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 48.|week 48|||cells/mm^3||Full Range|Median
61923|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 24.|week 24|||cells/mm^3||Full Range|Median
61924|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48|||participants|||Number
61925|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24|||participants|||Number
61926|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline|||participants|||Number
61927|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 48.|Week 48|||cells/mm^3||Full Range|Median
61928|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 24.|Week 24|||cells/mm^3||Full Range|Median
61929|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at baseline.|Baseline|||cells/mm^3||Full Range|Median
61930|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.|Week 48|||cells/mm^3||Full Range|Median
61931|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.|Week 24|||cells/mm^3||Full Range|Median
61932|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.|Baseline|||cells/mm^3||Full Range|Median
61933|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48|||participants|||Number
61934|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24|||participants|||Number
61935|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline|||participants|||Number
61936|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at baseline.|Baseline|||cells/mm^3||Full Range|Median
61937|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|week 48|||participants|||Number
61938|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|week 24|||participants|||Number
61939|NCT01190124|Primary|HIV-RNA Levels|Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline|||participants|||Number
62149|NCT01188603|Primary|Flibanserin: AUC τ,ss|Geometric mean of the AUC τ,ss of Flibanserin|8 days|All patients with values for the area under the concentration-time curve of the analyte in plasma over a dosing interval τ at steady state (AUC τ,ss)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
61940|NCT01190098|Secondary|Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4|Range 0 -10 where higher scores reflect better quality of life.|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
61941|NCT01190098|Secondary|Change in Daily Seizure Frequency From Baseline to Visit 4|Number of seizures per day.|Baseline to visit 4 (approximately 1 - 2 months)|2 subjects did not complete seizure diary at both time points.||number of seizures per day||Inter-Quartile Range|Median
61942|NCT01190098|Secondary|Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.|Range 0-27, where higher scores indicate more impairment (depressive symptoms)|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
61943|NCT01190098|Secondary|Change in Adverse Event Profile (AEP) From Baseline to Visit 4.|Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.|Baseline to visit 4 (approximately 1 - 2 months)|3 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
61944|NCT01190098|Secondary|Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.|Range 0-20 where lower scores indicate more impairment (sleep related QOL).|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
61945|NCT01190098|Secondary|Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4|Range 0-21, where higher scores more impairment (in terms of sleep quality).|Baseline to Visit 4 (approximately 1 - 2 months)|7 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
61946|NCT01190098|Secondary|Change in the Fatigue Severity Scale From Baseline to Visit 4.|Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.|Baseline to Visit 4 (approximately 1 - 2 months)|6 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.||units on a scale||95% Confidence Interval|Mean
61947|NCT01190098|Primary|Change in Epworth Sleepiness Scale Score From Baseline to Visit 4|Scale 0 - 24 Higher scores indicate more severe symptoms|Baseline and Visit 4 (approximately 1 - 2 months)|||Units on a scale||95% Confidence Interval|Mean
61948|NCT01190085|Primary|Salivation|Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of psychophysiological responses, namely salivation changes.|approximately 30 minutes after drug administration|||gram||Standard Deviation|Mean
61949|NCT01190085|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability.|Whether ghrelin intravenous (i.v.), as compared to saline i.v., does not significantly increase Adverse Events (AEs).|participants will be followed after the cue-reactivity experiment, an expected average of 7 days|||participants|||Number
61950|NCT01190085|Primary|Alcohol Visual Analogue Scale (A-VAS)|"Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Visual Analogue Scale (A-VAS)].~The A-VAS was rated on 11-point anchored Likert-type scales, where 0 is the minimum score (no craving) and 11 is the maximum score (highest craving intensity). The change in the A-VAS score (deltaA-VAS) was used to indicate decrease (-d) or increase (+d) in craving intensity."|approximately 30 minutes after drug administration|||units on a scale||Standard Deviation|Mean
61951|NCT01190007|Secondary|Percent Change From Baseline in Apolipoprotein B at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of Apolipoprotein B||Standard Deviation|Mean
61952|NCT01190007|Secondary|Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Ratio||Standard Deviation|Mean
61953|NCT01190007|Secondary|Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Ratio||Standard Deviation|Mean
61954|NCT01190007|Secondary|Percent Change From Baseline in Triglyceride (TG) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of TG||Standard Deviation|Mean
61955|NCT01190007|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of HDL-C||Standard Deviation|Mean
61956|NCT01190007|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of TC||Standard Deviation|Mean
61992|NCT01189617|Primary|"Number of Subjects With Irritation Score of 0 at:"|Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.|One Week|Full Analysis Set||Participants|||Number
61957|NCT01190007|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||Percentage of LDL-C||Standard Deviation|Mean
61958|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment.~Participants with both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia."||mmHg||Standard Deviation|Mean
61959|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||mmHg||Standard Deviation|Mean
61960|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.||mmHg||Standard Deviation|Mean
61961|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.||mmHg||Standard Deviation|Mean
61962|NCT01190007|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|52 weeks|The safety analysis set included all participants who took at least one dose of study drug.||Participants|||Number
61963|NCT01189890|Secondary|LS Mean Change From Baseline in Participant Body Weight at Week 30|Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30.|Baseline and Week 30|All randomized participants who received at least one dose of study treatment and had body weight measurements at baseline and at Week 30.||kg||95% Confidence Interval|Least Squares Mean
61964|NCT01189890|Secondary|Percentage of Participants With HbA1c <6.5% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||Percentage of Participants|||Number
61965|NCT01189890|Secondary|Percentage of Participants With HbA1c <7.0% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||Percentage of Participants|||Number
61966|NCT01189890|Secondary|LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG.|Baseline and Week 30|The population included all randomized participants who had a FPG value at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||mg/dL||95% Confidence Interval|Least Squares Mean
61967|NCT01189890|Primary|Number of Participants Discontinuing Study Treatment Due to An AE|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.||Participants|||Number
61968|NCT01189890|Primary|Number of Participants Experiencing An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.||Participants|||Number
61980|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
61969|NCT01189890|Primary|Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30|Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms.|Up to Week 30|All randomized participants who received at least one dose of study treatment.||Participants|||Number
61970|NCT01189890|Primary|Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30|Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Baseline and Week 30|The population included all randomized participants who had a baseline HbA1c, had a HbA1c at Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.||Percentage of HbA1c||95% Confidence Interval|Least Squares Mean
61971|NCT01189812|Secondary|Beck Scale for Suicide Ideation (BSS)|"The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny.~Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4"|4 weeks||||||
61972|NCT01189812|Secondary|Beck Hopelessness Scale (BHS)|"The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts.~Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4"|4 weeks||||||
61973|NCT01189812|Primary|Sheehan-Suicidality Tracking Scale (S-STS)|"The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide.~Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4."|4 weeks; from Baseline to Week 4|The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40).||Scores on a Scale (S-STSS)|Participants|Standard Deviation|Mean
61974|NCT01189760|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from Baseline for FLO-11 Question #8: “My facial lines make me look tired.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 3 are included.||Percentage of participants|||Number
61975|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: “My facial lines make me look less attractive than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.||Percentage of participants|||Number
61976|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: “When I look in the mirror, my facial lines make me look older than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.||Percentage of participants|||Number
61977|NCT01189760|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|Participants were considered to judge themselves as looking younger if the category change was from “look my current age” at Baseline to “look younger” at Day 30 or from “look older” at Baseline to “look my current age/younger” at Day 30.|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."||Percentage of participants|||Number
61978|NCT01189760|Secondary|Subject Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow’s Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
61979|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only those participants who were rated at least mild at Baseline are included in the analyses.||Percentage of participants|||Number
62150|NCT01188603|Primary|Flibanserin: Area Under the Curve; AUC_0-∞|Geometric mean of the AUC_0-∞ of Flibanserin|8 days|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
61981|NCT01189760|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
61982|NCT01189760|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.||Percentage of participants|||Number
61983|NCT01189747|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from baseline for FLO-11 Question #8: “My facial lines make me look tired” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 3 were included.||Percentage of participants|||Number
61984|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: “My facial lines make me look less attractive than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.||Percentage of participants|||Number
61985|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: “When I look in the mirror, my facial lines make me look older than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.||Percentage of participants|||Number
61986|NCT01189747|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|Participants were considered to judge themselves younger if the category change was from “look my current age” at Baseline to “look younger” at Day 30 or from “look older” at Baseline to “look my current age/younger” at Day 30.|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."||Percentage of participants|||Number
61987|NCT01189747|Secondary|Subject Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow’s Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.||Score on a scale||Standard Deviation|Mean
61988|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat participants included all randomized participants. Only participants who were rated at least mild at Baseline are included in the analyses.||Percentage of participants|||Number
61989|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
61990|NCT01189747|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator’s Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
61991|NCT01189747|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.||Percentage of participants|||Number
61993|NCT01189604|Secondary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)|||Participants|||Number
61994|NCT01189604|Secondary|Blood Concentrations of Propofol|Blood concentration of ICI35,868 (propofol)|At the end of the initiation period and every 2 minutes during the maintenance period|||µg/mL||Standard Deviation|Mean
61995|NCT01189604|Secondary|Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire|The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).|24 - 48 hours after completion of the procedure|||Units on a scale||Standard Deviation|Mean
61996|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|4 minutes from the beginning of the maintenance period|||Participants|||Number
61997|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|2 minutes from the beginning of the maintenance period|||Participants|||Number
61998|NCT01189500|Secondary|Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
61999|NCT01189500|Secondary|Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
62000|NCT01189500|Secondary|Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
62001|NCT01189500|Secondary|Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population: all participants randomized and treated who had at least 1 concentration in at least 1 treatment period. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.||ng/mL||Full Range|Median
62002|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
62003|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
62004|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Error|Mean
62040|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug~severe nausea: repeated administration of antiemetic drugs~vomiting:...........at least one vomiting event"|4 hours after surgery|intention to treat||participants|||Number
62005|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
62006|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
62007|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|4-hydroxy-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
62008|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
62009|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
62010|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Error|Mean
62011|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
62012|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
62013|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|N-desmethyl-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
62014|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
62015|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
62016|NCT01189500|Secondary|Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Deviation|Mean
62017|NCT01189500|Secondary|Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
62018|NCT01189500|Secondary|Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
62019|NCT01189500|Secondary|Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||liters||Standard Deviation|Geometric Mean
62020|NCT01189500|Secondary|Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||mL/min||Standard Deviation|Geometric Mean
62021|NCT01189500|Secondary|Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Standard Deviation|Mean
62022|NCT01189500|Secondary|Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.||hours||Full Range|Median
62023|NCT01189500|Secondary|Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
62024|NCT01189500|Primary|Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR|Endoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
62025|NCT01189500|Primary|Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|Pharmacokinetic (PK) parameter analysis population: all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
62026|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."||percentageof participants||95% Confidence Interval|Number
62041|NCT01189292|Secondary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)~any PONV event within 48 hours after surgery~PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery (PP)|per protocol analysis||percentage of participants||95% Confidence Interval|Number
66732|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)|||Percentage of participants|||Number
62027|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
62028|NCT01189487|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment.|Day 4|Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.||percentage of participants|||Number
62029|NCT01189487|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants EXCLUDING ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
62030|NCT01189487|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
62031|NCT01189461|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)|VA indicated sharpness or clarity of vision. BCVA assessed by early treatment diabetic retinopathy study chart using 4 meter (m), 1m distance, or if participant was able to count fingers, perceive hand motion or light. At 4m (>= 20 letters), VA score=number of letters correct plus 30 (credited for 30 letters at 1m); otherwise , VA score=number of letters read correctly at 1m plus number read at 4m (if any). If no letters were read correctly at 4m or 1m, VA score= 0, which were excluded from summary statistics calculation. BVCA score ranged: 0 (poor eyesight) to 78 (best eyesight).|Baseline, Week 48 (End of treatment)|Full analysis set included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies participants who had BVCA score greater than 0 at baseline and 'n' signifies those who were evaluable at each specified time point.||units on a scale||Standard Deviation|Mean
62032|NCT01189461|Primary|Mean Total Number of Injections|Mean number of injections per participant was calculated as (number of injection administered per participant – 1)/duration of treatment. Mean number of injections administered for total participants was summarized.|Baseline up to Week 48 (End of treatment)|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||injections||Standard Deviation|Mean
62033|NCT01189461|Secondary|Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Total number of participants who had ocular and non-ocular SAEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
62034|NCT01189461|Primary|Incidence of Ocular and Non-Ocular Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Total number of participants who had ocular and non-ocular AEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Same participant may be represented in more than 1 category.||participants|||Number
62035|NCT01189435|Primary|To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib|in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib|2 years||||||
62036|NCT01189292|Secondary|Necessary Anesthesiological Medication|Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group|measured from beginning of anaesthesia to end of anaesthesia|||milligram||Standard Deviation|Mean
62037|NCT01189292|Secondary|Length of Hospital Stay|Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group|Difference between day of admission and day of discharge|intention to treat||hour||Standard Deviation|Mean
62038|NCT01189292|Secondary|Postoperative Pain After Physical Stress|"Compare grade of pain between the treatment (dexamethasone) and the control (saline) group~Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1~before obtaining the pain rating, patients were asked to turn their heads (physical stress)"|4 and 8 hours after surgery|intention to treat analysis||units on a scale||Standard Deviation|Mean
62039|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug~severe nausea: repeated administration of antiemetic drugs~vomiting:...........at least one vomiting event"|8 hours after surgery|intention to treat||participants|||Number
62042|NCT01189292|Primary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)~any PONV event within 48 hours after surgery~PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery|intention to treat analysis||percentage of participants||95% Confidence Interval|Number
62043|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment|Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication||Patients|||Number
62044|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment|Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication||Patients|||Number
62045|NCT01189279|Secondary|Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings|An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm.|17 Days|Safety Population: all subjects who received at least 1 dose of study medication||Percentage of Patients|||Number
62046|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost|Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|17 Days|Per Protocol: all subjects with no major protocol deviations||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
62047|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost|Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|Day 1|Per Protocol: all subjects with no major protocol deviations||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
62048|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15. Only 4 pts samples were evaluable for AUC 24 at the10mg dose.||ng*h/mL||Standard Deviation|Mean
62049|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.|24hrs|Day 1||ng*h/mL||Standard Deviation|Mean
62050|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15 only. Level 2 10mg only had 5pts with evaluable PKs at day 15||ng/mL||Standard Deviation|Geometric Mean
62051|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|"all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected"|24 hrs|Day One only||ng/mL||Standard Deviation|Geometric Mean
62052|NCT01189240|Secondary|Toxicity Description (Dose Limiting Toxicity-DLT) of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort. Pts must receive one dose of treatment to be evaluated for toxicity. Toxcity description associated with combination of RO4929097 and Bevacizumab|28 days - 1 cycle|DLT Defintion, must be related to RO and/or Bev: ANC </= 500/μL or second time ANC <1,000/μL; PLTs </= 25,000/μL or second time platelets <50,000/μL; Febrile neutropenia;Thrombocytopenic bleeding (platelets <50,000/μL and with clinically significant bleeding); Delay of treatment > 14 days ;grade 3 or 4 non-hematological toxicity (some exceptions)||participants|||Number
62053|NCT01189240|Primary|Maximum-tolerated Dose and the Recommended Phase II Dose of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab Determined by Dose-limiting Toxicity Rate (Phase I)|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort if less than or equal to 33% dose will be escalated. Pts must receive one dose of treatment to be evaluated for toxicity. A standard 3+3 dose escalation method will be used|28 days|RO4929097 Days 1-3 weekly (doses 5,10, 20 mg) + Bev 10mg/kg IV q2 wks - cycle 28 days. 3+3 dose escalation method will be used. Target DLT is > or equal to 33%||mg|||Number
62054|NCT01189227|Secondary|Frequencies of Adverse Events as Assessed by the NCI CTCAE v4.0||From study entry through 3 months after the last treatment dose.||||||
62055|NCT01189227|Secondary|Frequencies of Selected Postoperative Surgical Complications and Other Adverse Events Within 30 Days of Surgery||Assessed within 30 days from the time of surgery||||||
62056|NCT01189227|Secondary|The Difference in R0 and Combined R0 + R1 Resection Rates Between the Two Arms.||Assessed at the time of surgery||||||
62057|NCT01189227|Secondary|Overall Survival||From study entry until the time of death or for a maximum of 5 years.||||||
62058|NCT01189227|Secondary|RFS of Patients Event-free||From study entry until the date of recurrence or for a maximum of 6 months.||||||
66786|NCT01140646|Secondary|Adverse Event Grade Incidence||End of study||||||
62060|NCT01189201|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination.|Drug administration until next treatment period/end-of-study examination, up to 36 days|Treated set (TS) included all subjects who were documented to have taken at least one dose of investigational treatment.||participants|||Number
62061|NCT01189201|Primary|Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62062|NCT01189201|Primary|Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
62063|NCT01189201|Secondary|Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62064|NCT01189201|Primary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62065|NCT01189201|Primary|Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
62066|NCT01189201|Secondary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62067|NCT01189201|Primary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62068|NCT01189201|Primary|Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
66787|NCT01140646|Secondary|Change From Baseline in Self-assessment Items||End of study||||||
62069|NCT01189201|Secondary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62070|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62071|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
62072|NCT01189201|Secondary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62073|NCT01189201|Secondary|Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62074|NCT01189201|Secondary|Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62075|NCT01189201|Secondary|Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of linagliptin in plasma|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Full Range|Median
62076|NCT01189201|Secondary|Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||hours||Full Range|Median
62077|NCT01189201|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
62161|NCT01188538|Secondary|Percent Change (%) in Inflammatory Lesion Counts|Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.|Week 12|ITT (LOCF)||Percent change (%)||Full Range|Median
62078|NCT01189201|Primary|Empagliflozin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
62079|NCT01189201|Primary|Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62080|NCT01189201|Primary|Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
62081|NCT01189136|Other Pre-specified|Pain From Treatment|Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)|30 minutes|||units on a scale||Standard Deviation|Mean
62082|NCT01189136|Other Pre-specified|Questionnaire Data - Impression of Allocation|"Participants were asked to guess to which treatment arm they had been allocated (PTNS Sham or I Don't Know). Outcome was measured as the number of patients in each arm accurately determining their allocation."|30 minutes|Number||number of participants|||Number
62083|NCT01189136|Secondary|Amount of Improvement in Voiding Efficiency|Improvement of voiding efficiency, as measured by dividing the volume voided by the total volume (voided volume + retained volume) per participant. Each participant is evaluated separately, and the mean percentage of improvement was calculated for each arm.|30 minutes|||percentage of voided vol/total volume||Standard Deviation|Mean
62084|NCT01189136|Primary|Persistent Retention|Number of participants with persistent unsuccessful trial of void after the intervention|30 minutes|||participants|||Number
62085|NCT01189123|Secondary|Antibody Responses|Hemagglutination inhibition antibody titers measured for standard vs high dose|2 years|||GMT||95% Confidence Interval|Geometric Mean
62086|NCT01189123|Primary|Cellular Immune Response|comparison of CMI in high vs standard dose|3 years|A subset of samples were chosen for testing since not enough money was available to test samples from all subjects. The samples were divided by randomization group (blinded to study staff -- they were called group A or group B). From each group, samples were randomly pulled.||percentage of Stimulated cells||Inter-Quartile Range|Median
62087|NCT01189110|Primary|Percentage of Self-reported Abstinence at 6 Weeks.|Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).|6 weeks|A middle-aged, US military veteran population not free of smoking (at least 10 cigarettes per day) and not currently in reciept of any other form of smoking cessation intervention.||percentage of participants||95% Confidence Interval|Number
62088|NCT01189071|Secondary|Decreased Use of Narcotic and Anticholinergic Medication Use Postoperatively.|"Decreased use of narcotic and anticholinergic medication use postoperatively, compared to the standard of care patient"|end of study with 30 patients recruited|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.|||||
62089|NCT01189071|Primary|Decreased Post Operative Ureteral Stent Pain, Evidenced by Decreased Pain Scores, Less ER Visits/Hospital Admits, or Patient Phone Calls for Stent Pain/Difficulty|"Decreased post operative ureteral stent pain, evidenced by decreased pain scores, less ER visits/hospital admits, or patient phone calls for stent pain/difficulty, as compared to the standard of care patient with no preop Darifenacin"|24 months|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.|||||
62090|NCT01189032|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.~The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued(LOCF))|"Efficacy analysis was performed per protocol set (PPS). Excluded cases were 7 subjects (3 subjects in 3% group, 3 subjects in 1% group, and 1 subject in Placebo group).~The reason of exclusion: used the prohibited concomitant drug, dosing period shortage, number of doses non-compliance, or had no available efficacy data."||points||Standard Deviation|Mean
62091|NCT01188967|Secondary|Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications|"The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo two weeks after discontinuation of double blind study medications.~7-day, Point-prevalence tobacco abstinence was defined as not smoking for the 7 consecutive days before this visit after discontinuation of double blind study medications"|Week 10 of the study|7 participants completed this visit. None of them were abstinent from smoking||Participants|||Count of Participants
62092|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of 6 weeks exposure to GSK598809/placebo.|Week 8 of the study|7 participants completed week 6 weeks exposure to GSK598809/placebo. None of our participants had 7 day point prevalence tobacco abstinence at this time point||Participants|||Count of Participants
62093|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of the first week of exposure to GSK598809/placebo.|Week 3 of the study|13 participants completed week 1 visit||Participants|||Count of Participants
62094|NCT01188967|Primary|4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)|Week 8 of the study|9 participants completed this visit||Participants|||Count of Participants
62095|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 8|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 8 weeks|||percentage of change in PASI||Standard Deviation|Mean
62096|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 4|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 4 weeks|||percentage of change in PASI||Standard Deviation|Mean
62097|NCT01188928|Primary|Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 8|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|week 8|||participants|||Number
62098|NCT01188928|Primary|Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 4|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|4 weeks|||participants|||Number
62099|NCT01188811|Secondary|Safety Measure: Adverse Events||adverse events recorded from baseline to year 2|Intention-to-treat analysis was performed on 27 participants in the lipoic acid group and 24 in the placebo group.||occurences|||Number
62100|NCT01188811|Secondary|Disability Measures: Mobility||Change in Timed 25 Foot Walk from baseline to year 2|Outliers were removed and intention-to-treat analysis was performed on data from 21 participants in the lipoic acid group and 17 in the placebo group.||seconds||Standard Deviation|Mean
62101|NCT01188811|Primary|Brain Atrophy by MRI||% change brain volume from baseline to year 2|22 subjects in the lipoic acid group and 24 in the placebo group completed the MRI outcome. Two outliers in the lipoic acid group were not included in analysis.||whole brain percent volume change||Standard Deviation|Mean
62102|NCT01188798|Secondary|Assess Overall Survival, Relapse, Engraftment, and Regimen-related Morbidity and Estimating Cumulative Incidence of Pulmonary Adverse Events and Mucositis.|To characterize the pharmacokinetic-pharmacodynamic relationships of pentostatin in this patient population and to assess the relationship between pre-transplant minimal residual disease (MRD) and transplant outcomes.|42 days post- transplant|Insufficient data was available to answer objectives.|||||
62103|NCT01188798|Primary|Determining Whether the Hepatic Adverse Event-free (NCI Grades II-IV) Survival at Day 42 After an HLA-matched Transplant for Hematologic Malignancy Can be Improved by Using a GVHD Prophylaxis Regimen That Includes Pentostatin Rather Than MTX.|The hypothesis was that individuals receiving the drug pentostatin as GVHD prophylaxis would experience less severe hepatic toxicity than those receiving methotrexate as GVHD prophylaxis. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 grade 2 or above hepatic toxicity-free survival in pentostatin recipients|42 days post-transplant|Insufficient data was available to answer objectives|||||
62104|NCT01188772|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir|Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24.|Baseline to Week 12|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.||percentage of participants|||Number
62105|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.||ng•h/mL||Standard Deviation|Mean
62185|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|24 months after denture completion|For study participants who completed the 24-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 24-month lower-denture assessment||participants|||Number
62106|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.||ng•h/mL||Standard Deviation|Mean
62107|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.||ng•h/mL||Standard Deviation|Mean
62108|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.||ng/mL||Standard Deviation|Mean
62109|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.||ng/mL||Standard Deviation|Mean
62110|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.||ng/mL||Standard Deviation|Mean
62111|NCT01188772|Secondary|Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)|SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively.|Post-treatment Weeks 12 and 24|Safety Analysis Set||percentage of participants|||Number
62112|NCT01188772|Secondary|Percentage of Participants With Virologic Response at the End of Treatment|End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit.|Week 48 (genotype 1) or Week 12 (genotype 2/3)|Participants in the Safety Analysis Set with available data were analyzed. One participant in the Sofosbuvir 400 mg (Genotype 2/3) Group was lost to follow up before the end of treatment and is not included in this analysis.||percentage of participants|||Number
62113|NCT01188772|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12.|Week 4 to Week 12|Safety Analysis Set||percentage of participants|||Number
62114|NCT01188772|Secondary|Percentage of Participants With Complete Early Virologic Response at Week 12|Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12|Week 12|Safety Analysis Set||percentage of participants|||Number
62115|NCT01188772|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29)|Week 4|Safety Analysis Set||percentage of participants|||Number
62116|NCT01188772|Secondary|Change in HCV RNA From Baseline to Week 12||Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.||log10 IU/mL||Standard Deviation|Mean
62117|NCT01188772|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 12 plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study drug||percentage of participants|||Number
62118|NCT01188681|Secondary|Response Per NCI Criteria|Overall response rate per National Cancer Institute (NCI) Working group criteria.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Safety data for all patients who received any study drug and efficacy data for randomized patients who received some study treatment and have some post baseline data are presented here.||percentage of patients|||Number
62119|NCT01188681|Primary|Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria|Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Treated patients||percentage of patients|||Number
62120|NCT01188668|Secondary|Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.||ng/mL||Full Range|Median
73811|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and 52 week after|||g/dL||Standard Deviation|Mean
62121|NCT01188668|Secondary|Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.||ng/mL||Full Range|Median
62122|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||liters||Standard Deviation|Geometric Mean
62123|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.||mL/min||Standard Deviation|Geometric Mean
62124|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||hours||Standard Deviation|Mean
62125|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=number of participants contributing to the mean.||hours||Full Range|Median
62126|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing|PK parameter analysis population. N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
62127|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Dehydro-aripiprazole is a metabolite of Aripiprazole. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
62128|NCT01188668|Secondary|Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||liters||Standard Deviation|Geometric Mean
62129|NCT01188668|Secondary|Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||mL/min||Standard Deviation|Geometric Mean
62130|NCT01188668|Secondary|Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||hours||Standard Deviation|Mean
62131|NCT01188668|Secondary|Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the median.||hours||Full Range|Median
62132|NCT01188668|Secondary|Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
62133|NCT01188668|Primary|Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|Pharmacokinetic (PK) parameter analysis population: all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=Number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
62134|NCT01188655|Secondary|Spine Agility Function by Ott Test|The Ott index determines the agility of the thoracic spine.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||cm||Standard Deviation|Mean
62135|NCT01188655|Secondary|Spine Agility Function by Schober Test|Schober test determines agility of lumbar spine. It measures participant’s ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||cm||Standard Deviation|Mean
62136|NCT01188655|Secondary|Mean Occiput-to-wall Distance at Week 12 and Week 24||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||cm||Standard Deviation|Mean
62137|NCT01188655|Secondary|Percentage of Participants Without Peripheral Arthritis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Percentage of Participants|||Number
62138|NCT01188655|Secondary|Percentage of Participants Without Enthesitis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Percentage of Participants|||Number
62139|NCT01188655|Secondary|Change From Baseline in ASQoL at Week 12 and Week 24|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Units on a scale||Standard Deviation|Mean
62140|NCT01188655|Secondary|Mean Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||minutes||Standard Deviation|Mean
62141|NCT01188655|Secondary|Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||mm||Standard Deviation|Mean
62142|NCT01188655|Secondary|Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24|Measured using a 100mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Units on a scale||Standard Deviation|Mean
62143|NCT01188655|Secondary|Change From Baseline in the BASFI at Weeks 12 and 24|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||Units on a scale||Standard Deviation|Mean
62144|NCT01188655|Secondary|Change From Baseline in BASDAI at Week 12 and 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.||units on a scale||Standard Deviation|Mean
62145|NCT01188655|Primary|Percentage of Participants Achieving BASDAI 40 Response at Week 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.|Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point||Percentage of participants|||Number
73812|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and 52 week after|||*10000/μl||Standard Deviation|Mean
62151|NCT01188577|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
62152|NCT01188577|Primary|Half-life (t1/2) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Full Range|Mean
62153|NCT01188577|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Standard Deviation|Mean
62154|NCT01188577|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg*min/mL||Standard Deviation|Mean
62155|NCT01188577|Primary|Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
62156|NCT01188577|Primary|Baseline Concentration (C0) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurement btwn 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
62157|NCT01188564|Secondary|Time to Minimal Symptoms|"The key secondary efficacy endpoint was the time to minimal symptoms at all locations. The time to achieving minimal symptoms was defined as an answer of Yes to TEQ question 3."|24 hours|||minutes||Full Range|Median
62158|NCT01188564|Primary|Time to Beginning of Relief of Symptoms|"Time to beginning of relief is the time lapsed from the beginning of the infusion of study medication to the beginning of a beneficial effect based on patient's responses to the Treatmetn Effect Questionnaire (TEQ) for the primary attack location. The beginning of relief is defined as the first timepoint at which~The patient reports any of the following answers for TEQ question 1: A little better, Better or Much better; and;~The patient reports the following answer for TEQ question 2: Yes; and,~There is persistence in improvement at the next assessment time, i.e.either the same or a better response to Question 1 and Yes to Question 2."|Patients observed for 24 hours|||minutes||95% Confidence Interval|Median
62159|NCT01188551|Secondary|Recovery From General Anesthesia|Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.|30 mins. post-op|||units on a scale||Standard Deviation|Mean
62160|NCT01188551|Primary|FLACC Behavioral Pain Assessment Scale Scores|"FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.~0 = Relaxed and comfortable 1–3 = Mild discomfort 4–6 = Moderate pain 7–10 = Severe discomfort or pain or both"|30 mins. post-op|||units on a scale||Standard Deviation|Mean
62906|NCT01181011|Secondary|Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Telmisartan||L||Standard Deviation|Mean
62162|NCT01188538|Primary|Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes|"Quantitative bacterial examinations were performed on the subjects’ face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes.~Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study."|Week 12|Intent To Treat (ITT)/Last Observation Carried Forward (LOCF)||Log10 cfu/cm²||Standard Deviation|Mean
62163|NCT01188499|Secondary|Evaluation of Pharmacokinetics and Translational Biomarkers|Measurement of TL32711 pharmacokinetics: Maximum plasma concentration (Cmax), area under the curve (AUC), half-life (t1/2) and assessment of translational biomarkers in plasma, PBMC's and tumor biopsies. Gene expression profiling of tumor tissue.|Cycle 1 and Cycle 2||||||
62164|NCT01188499|Secondary|Evaluation of Anti-tumor Efficacy|Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST) and time to progression|Every 2 cycles|Intent-to-treat (ITT)||participants|||Number
62165|NCT01188499|Primary|Number of Subjects With Adverse Events as a Measure of Safety and Tolerability|Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters|1 Cycle (3-4 weeks)|||participants|||Number
62166|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.||Participants|||Number
62167|NCT01188343|Other Pre-specified|Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil).|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Full Analysis Set.||Participants|||Number
62168|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.||Participants|||Number
62169|NCT01188343|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).|Pre-vaccination and Day 42 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data.||Titers||95% Confidence Interval|Geometric Mean
62170|NCT01188343|Secondary|Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m|Pre-vaccination and up to Month 12 post-vaccination|Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set.||Participants|||Number
62171|NCT01188343|Secondary|Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m|Pre-vaccination and Day 42 post-vaccination|Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set).||Percentage of Participants|||Number
62186|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|18 months after denture completion|For study participants who completed the 18-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 18-month lower-denture assessment||participants|||Number
62172|NCT01188343|Primary|Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.|Day 0 (pre-vaccination) and Day 42 post-vaccination|Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data.||Percentage of Participants|||Number
62173|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62174|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62175|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62176|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62177|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62178|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62179|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|24 months after denture completion|For study participants who completed the 24-month follow-up.||participants|||Number
62180|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|18 months after denture completion|For study participants who completed the 18-month follow-up.||participants|||Number
62181|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)|12 months after denture completion|For study participants who completed the 12-month follow-up.||participants|||Number
62182|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62183|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62184|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|6 months after denture completion|||participants|||Number
62187|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|12 months after denture completion|For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome.||participants|||Number
62188|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal).|6 months after denture completion|For study participants who completed the 6-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.||participants|||Number
62189|NCT01188109|Secondary|Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression|To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1–10%; 2 = 11–50%; 3 = 51–100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: [(1+intensity score)/3]*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and > 2 was high ERCC1 expression.|At the time of resection|Twenty patients had tissue available for ERCC1 analysis.||patients|||Number
62190|NCT01188109|Primary|Recurrence-free Survival as Measured by CT Scan|Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.|Every 3 months and then every 6 months for 2 more years after resection|||months||95% Confidence Interval|Median
62191|NCT01187953|Secondary|For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period (day 1 to day 734): death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|734 days|All 543 randomized patients were included in the analysis population.||participants|||Number
62192|NCT01187953|Primary|The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|360 days|All 543 randomized patients were included in the analysis population.||participants|||Number
62193|NCT01187914|Primary|Left Atrial (LA) Remodeling Pre-ablation|Utah staging for fibrosis (I - <=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - >=35.01%)|Once pre-ablation|||participants|||Number
62194|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.||polyps||Inter-Quartile Range|Median
62195|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Classic FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both||polyps||Inter-Quartile Range|Median
62196|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count).|Baseline and 6 months|||polyps||Inter-Quartile Range|Median
62197|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.||mm||Inter-Quartile Range|Median
62198|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Classic Familial Adenomatous Polyposis (FAP) Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both.||mm||Inter-Quartile Range|Median
62199|NCT01187901|Primary|Change in Duodenal Polyp Burden From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|||mm||Inter-Quartile Range|Median
62283|NCT01187017|Secondary|Secondary Endpoints Will Evaluated for the Study to Include: (a) Hematologic Response at 3 and 12 Months and Yearly Thereafter; (b) Relapse (c) Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH), Myelodysplasia or Acute Leukemia; (e) Survival.||12 months||||||
62200|NCT01187550|Secondary|Change From Baseline in Lipid Profile at Week 4|Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||mmol/L||Standard Deviation|Mean
62201|NCT01187550|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4|HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||pmol/L*mmol/L||Standard Deviation|Mean
62202|NCT01187550|Secondary|Change From Baseline in Fasting Insulin at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||picomole/L (pmol/L)||Standard Deviation|Mean
62203|NCT01187550|Secondary|Change From Baseline in Fasting Glucose at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.||millimole/liter (mmol/L)||Standard Deviation|Mean
62204|NCT01187550|Secondary|Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication.||microgram/mL (mcg/mL)||Standard Deviation|Mean
62205|NCT01187550|Primary|Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4|Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.|Baseline and Week 4|The intent-to-treat (ITT) population set included all the participants who received at least 1 dose of study medication.||nanogram/millilter (ng/mL)||Standard Deviation|Mean
62206|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62207|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62208|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62209|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62210|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62211|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62212|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
75237|NCT01054703|Primary|Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant||Procedural and 6 weeks post-implant|||participants|||Number
62213|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62214|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62215|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62216|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62217|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62218|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62219|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62220|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62221|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62222|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62223|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62224|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62225|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62226|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62227|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62228|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62229|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62230|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62231|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62284|NCT01187017|Primary|Response Rate at 6 Months|The primary objective is to assess the Flu/Cy hematological response in SAA.The primary endpoint will be response at six months.|6 months|||participants|||Number
62907|NCT01181011|Secondary|Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Telmisartan||L/h||Standard Deviation|Mean
62232|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62233|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62234|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62235|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period||Units on a scale||Standard Error|Least Squares Mean
62236|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
62237|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
62238|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
62239|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
62240|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure||Units on a scale||Standard Error|Least Squares Mean
62241|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62285|NCT01187004|Secondary|Intensive Care Unit (ICU) Length of Stay|If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.|at 28 days|The analysis of the Intensive Care Unit (ICU) length of stay was done on all the patients included in the study. We want to evaluate if the development of acute lung injury prolongs the intensive care unit length of stay.ICU length of stay was calculated up to 28 days,and patients who died before were considered as having the maximum value||days||Inter-Quartile Range|Median
62242|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62243|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62244|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62245|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62246|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62247|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62248|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62249|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62250|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62251|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62252|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62310|NCT01186744|Secondary|Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe|Baseline and Weeks 4, 8, 16 and 24 (Period A)|FAS-A||percentage of participants|||Number
62253|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62254|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62255|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62256|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||Units on a scale||Standard Error|Least Squares Mean
62257|NCT01187498|Secondary|Patient Desire for Alternate Treatment|"Patient response to Do you wish to receive another form of treatment? (yes)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
62258|NCT01187498|Secondary|Patient Global Rating of Bothersomeness of Side Effects|"Patient global rating of how bothersome their side effects were (no side effects to extremely bothersome)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
62259|NCT01187498|Secondary|Patient Report of Symptom Distress|"Patient report of how disturbed they were by symptoms (not at all to extremely)"|post-treatment (week 8)|Completers minos one missing value||participants|||Number
62260|NCT01187498|Secondary|Patient Global Rating of Activity Restriction|"Patient global rating of activity restriction (not at all to all the time)"|post-treatment (week 8)|Com0leters minus one missing value||participants|||Number
62261|NCT01187498|Secondary|Patient Satisfaction|"Patient global rating of satisfaction with progress in treatment (completely satisfied to very dissatisfied)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
62262|NCT01187498|Secondary|Patient Global Perception of Improvement (GPI)|"Patient global perception of improvement (much better to much worse)"|post-treatment (week 8)|Completers minus one missing value||participants|||Number
62263|NCT01187498|Secondary|Change on American Urological Association (AUA) Symptom Index|Change in score on American Urological Association (AUA) Symptom Index (baseline to week 8). The index measures lower urinary tract symptoms. Scores range from 0 to 35, with higher scores indicating worse symptoms.|baseline to post-treatment (week 8)|Completers||Scores on the scale||Standard Deviation|Mean
62264|NCT01187498|Secondary|Percent Change in Frequency of Urge Incontinence|Percent change in frequency of urge incontinence episodes based on 7-day bladder diary. Percent change was calculated as ([frequency at baseline] - [frequency at 8 weeks]) / (frequency at baseline).|baseline to post-treatment (week 8)|Included participants who experienced incontinence at baseline only||Percent change in episodes per week||Standard Deviation|Mean
62265|NCT01187498|Secondary|Change in Urgency Severity|"Indevus Urgency Severity Scale incorporated into the 7-day bladder diary. Scores for urgency severity ranged from 0 to 3:~0: None—no urgency~Mild—awareness of urgency, but is easily tolerated.~Moderate—enough urgency discomfort that it interferes with or shortens usual activity~Severe—extreme urgency discomfort that abruptly stops all activities or tasks."|baseline to post-treatment (week 8)|Participants who completed treatment and returned bladder diary with useable urgency scores||Score on scale||Standard Deviation|Mean
62266|NCT01187498|Secondary|Change in Nocturia Frequency|Change in frequency of nocturia episodes based on 7-day bladder diary|baseline to post-treatment (week 8)|||nocturia episodes per night||Standard Deviation|Mean
62267|NCT01187498|Primary|24-hour Voiding Frequency|Mean voiding frequency per 24 hours derived from 7-day bladder dairy|post-treatment (week 8)|Treatment completers||voids per 24-hour day||Standard Deviation|Mean
62268|NCT01187433|Primary|Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo|Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post each vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
62269|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
62270|NCT01187433|Primary|Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
62271|NCT01187433|Primary|Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
62272|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
62273|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
62274|NCT01187433|Primary|Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
62275|NCT01187433|Primary|Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
62276|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 Days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
62277|NCT01187433|Primary|Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
62278|NCT01187433|Primary|Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.||Percentage of participants|||Number
62279|NCT01187355|Secondary|Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.||Units on a scale||Standard Deviation|Mean
62280|NCT01187355|Secondary|Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.||Units on a scale||Standard Deviation|Mean
62281|NCT01187355|Primary|Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.||Units on a scale||Standard Deviation|Mean
62282|NCT01187043|Primary|Induction Amenorrhea|Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.|10 weeks|Per protocol: subjects who exhibited trough levels of proellex on at least 7 of the 10 weekly visits during the dosing period||participants|||Number
62286|NCT01187004|Primary|Acute Lung Injury After Cardiac Surgery|to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 <300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.|at seven days after intervention|Patients consecutively admitted to the cardiac Intensive Care Unit (cICU) after cardiac surgery on cardiopulmonary by pass (CPB), during a time frame of two years.The analysis was per protocol, to identify the predictors of acute lung injury after cardiac surgery.||participants|||Number
62287|NCT01186939|Primary|Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period|Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption.|43- 68 months|Safety population includes all 40 participants in the extension study.||participants|||Number
62288|NCT01186848|Primary|Live-rater by Two Blinded Dermatologists|"The primary outcome was a blinded rating of the treatment area (Fractional Laser vs. Fractional Laser plus Intense Focused Ultrasound) with the best cosmetic appearance. Two dermatologists blindly evaluated the treated and control areas of each side from live subjects on the final follow up visit (week 10). This was reported as percentages of participants for whom 1550-nm Erbium-doped Fractionated Laser or Micro-focused Ultrasound and 1550nm-fractionated Laser resulted in the best cosmetic appearance."|week 10|||Percentage of participants||95% Confidence Interval|Number
62289|NCT01186796|Secondary|Mean GH Half-Life in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||min||Standard Error|Mean
62290|NCT01186796|Secondary|Mean Duration of GH Bursts (Mode) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||min||Standard Error|Mean
62291|NCT01186796|Secondary|Mean Mass of GH Released Per Burst in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||ug/L||Standard Error|Mean
62292|NCT01186796|Secondary|Mean GH Concentration (Pulsatile) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated by averaging values over the 6 hour collection timeframe.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||ug/L/6h||Standard Error|Mean
62293|NCT01186796|Primary|Mean Baseline GH Concentration|Averaged over 90-min baseline on the saline day.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.|||ug/L||Standard Error|Mean
62294|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)||Weeks 4, 8, and 16 (Period C)|Safety-C||percentage of participants|||Number
62295|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)||Weeks 4, 8, 12, and 16 (Period B)|Safety-B||percentage of participants|||Number
62296|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)||Weeks 4, 8, 16, and 24 (Period A)|Safety-A||percentage of participants|||Number
62297|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
62298|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation||scores on a scale||Standard Error|Mean
62299|NCT01186744|Secondary|Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62908|NCT01181011|Secondary|Elimination Half-life (t_½) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Telmisartan||h||Standard Deviation|Mean
62300|NCT01186744|Secondary|Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation.||score on a scale||Standard Error|Mean
62301|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
62302|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation||scores on a scale||Standard Error|Mean
62303|NCT01186744|Secondary|Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62304|NCT01186744|Secondary|Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n=number of participants with an observation.||score on a scale||Standard Error|Mean
62305|NCT01186744|Secondary|Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
62306|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
62307|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
62308|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants|||Number
62309|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percentage of participants|||Number
62311|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-C defined as the last observation up to first dosing date in Period C.|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
62312|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-A defined as the last observation up to first dosing date in Period A.|Week 24 (Period A)|FAS-A; n=number of participants with an observation||scores on a scale||Standard Error|Mean
62313|NCT01186744|Secondary|Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62314|NCT01186744|Secondary|Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation||score on a scale||Standard Error|Mean
62315|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 56 (Period C)|FAS-C||scores on a scale||Standard Error|Mean
62316|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
62317|NCT01186744|Secondary|Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62327|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5||percentage of participants||95% Confidence Interval|Number
62909|NCT01181011|Secondary|Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Telmisartan||h||Standard Deviation|Mean
62318|NCT01186744|Secondary|Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and standard deviations (SDs) of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation||score on a scale||Standard Error|Mean
62319|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.||weeks||95% Confidence Interval|Median
62320|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
62321|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.||weeks||95% Confidence Interval|Median
62322|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
62323|NCT01186744|Secondary|Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants|||Number
62324|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C DLQI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
62325|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI >1 where Baseline-B defined as last observation up to first dosing date in Period B.||percentage of participants|||Number
62326|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≤1, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
62328|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI ≥5.||percentage of participants|||Number
62329|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≥5, where Baseline-A is defined as the last observation up to first dosing date in Period A. n=participants with an observation.||percentage of participants||95% Confidence Interval|Number
62330|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||scores on a scale||Standard Error|Mean
62331|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||scores on a scale||Standard Error|Mean
62332|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
62333|NCT01186744|Secondary|Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62334|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
62335|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
62336|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||scores on a scale||Standard Error|Mean
62337|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||scores on a scale||Standard Error|Mean
62338|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
62339|NCT01186744|Secondary|Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
62340|NCT01186744|Secondary|Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62341|NCT01186744|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
62342|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.||weeks||95% Confidence Interval|Median
62343|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI ≥2, where Baseline-C defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
62344|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.||weeks||95% Confidence Interval|Median
62345|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
62596|NCT01184417|Secondary|Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability|"The outome answeres the question Did the study patient require endotracheal intubation, or not. This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation."|1 year|||participants|||Number
62346|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.||weeks||95% Confidence Interval|Median
62347|NCT01186744|Secondary|ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
62348|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.||weeks||95% Confidence Interval|Median
62349|NCT01186744|Secondary|ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
62350|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI ≥2, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
62351|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI ≥2, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
62352|NCT01186744|Secondary|Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
62353|NCT01186744|Secondary|Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI >1, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
62354|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI greater than (>) 0, where Baseline-C is defined as the last observation up to first dosing date in Period C.||percentage of participants||95% Confidence Interval|Number
62355|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI greater than (>) 0, where Baseline-A is defined as the last observation up to first dosing date in Period A.||percentage of participants||95% Confidence Interval|Number
62356|NCT01186744|Secondary|Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||score on a scale||Standard Error|Mean
62357|NCT01186744|Secondary|Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
62358|NCT01186744|Secondary|Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
62359|NCT01186744|Secondary|Mean ISI Score During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62360|NCT01186744|Secondary|Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
62361|NCT01186744|Secondary|Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
62362|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
62363|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percentage of participants|||Number
62364|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)|PASI quantifies the severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
62365|NCT01186744|Secondary|Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
62366|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
62597|NCT01184417|Secondary|Length of Stay|hospital LOS, per patient, in hours from admission to discharge|1 year|||hours||Inter-Quartile Range|Median
62367|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percentage of participants||95% Confidence Interval|Number
62368|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
62369|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
62370|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; NRI||percentage of participants||95% Confidence Interval|Number
62371|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||score on a scale||Standard Error|Mean
62372|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation||score on a scale||Standard Error|Mean
62373|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||score on a scale||Standard Error|Mean
62374|NCT01186744|Secondary|Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||score on a scale||Standard Error|Mean
62598|NCT01184417|Primary|Total Lorazepam Required Per Patient Per Admission|How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.|1 year|||milligrams||Standard Deviation|Mean
62375|NCT01186744|Secondary|Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation||score on a scale||Standard Error|Mean
62376|NCT01186744|Secondary|Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||score on a scale||Standard Error|Mean
62377|NCT01186744|Secondary|Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-C defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||scores on a scale||Standard Error|Mean
62378|NCT01186744|Secondary|Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-B defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||scores on a scale||Standard Error|Mean
62379|NCT01186744|Secondary|Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||scores on a scale||Standard Error|Mean
62380|NCT01186744|Secondary|Mean PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||score on a scale||Standard Error|Mean
62381|NCT01186744|Secondary|Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||score on a scale||Standard Error|Mean
62436|NCT01186419|Secondary|Maximum Plasma Concentration (Cmax) of SPD602|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|92 weeks|Pharmacokinetic (PK) Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.||ng/ml||Standard Deviation|Mean
62599|NCT01184417|Primary|Percentage of Patients Requiring ICU Admission|admission to intensive care unit|1 year|||percentage of participants|||Number
62382|NCT01186744|Secondary|Mean PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A||score on a scale||Standard Error|Mean
62383|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Baseline defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
62384|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent psoriatic BSA||Standard Error|Mean
62385|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||percent change in psoriatic BSA||Standard Error|Mean
62386|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
62387|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent psoriatic BSA||Standard Error|Mean
62388|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
62389|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Baseline was defined as the last observation until first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation||percent change in psoriatic BSA||Standard Error|Mean
62390|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent change in psoriatic BSA||Standard Error|Mean
62391|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation||percent change in psoriatic BSA||Standard Error|Mean
62392|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation||percent psoriatic BSA||Standard Error|Mean
62393|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations||percent psoriatic BSA||Standard Error|Mean
62437|NCT01186419|Primary|Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks|LIC was determined by R2 Magnetic Resonance Imaging (MRI).|Baseline and 96 weeks|Full Analysis Set, defined as all subjects in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all subjects who received any amount of investigational product.||mg/g||Standard Deviation|Mean
75238|NCT01054625|Secondary|Apparent Volume of Distribution at Steady State||8 weeks|||L||Geometric Coefficient of Variation|Geometric Mean
62394|NCT01186744|Secondary|Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals the number of participants with an observation.||percent psoriatic BSA||Standard Error|Mean
62395|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
62396|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants|||Number
62397|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
62398|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
62399|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants|||Number
62400|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
62401|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C||Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||weeks||95% Confidence Interval|Median
62402|NCT01186744|Secondary|Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||weeks||95% Confidence Interval|Median
62403|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
62404|NCT01186744|Secondary|Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C||weeks||95% Confidence Interval|Median
62405|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
62406|NCT01186744|Secondary|Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)||Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B||weeks||95% Confidence Interval|Median
62407|NCT01186744|Secondary|Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)|Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.|Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
62438|NCT01186406|Secondary|Unacceptable Toxicity Related to the Treatment Regimen|The number of patients experiencing unacceptable toxicity defined as the occurrence of ≥ grade 2 CNS hemorrhage or treatment-related grade 4 or 5 non-hematologic toxicity.|27 months|||participants|||Number
62910|NCT01181011|Secondary|Terminal Rate Constant in Plasma (λz) of Telmisartan|reflect the speed of drug elimination in vivo|3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Telmisartan||1/h||Standard Deviation|Mean
62408|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 16 of Period B.||percentage of participants|||Number
62409|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4 and 8 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 8 of Period B.||percentage of participants||95% Confidence Interval|Number
62410|NCT01186744|Secondary|Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||weeks||95% Confidence Interval|Median
62411|NCT01186744|Secondary|Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
62412|NCT01186744|Secondary|Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)|PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||percentage of participants||95% Confidence Interval|Number
62413|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 16, and 24 (Period A)|FAS-A||weeks||95% Confidence Interval|Median
62414|NCT01186744|Secondary|Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.|Weeks 4, 8, 16, and 24 (Period A)|The Period A-Full Analysis Set (FAS-A) included all participants who were randomized at baseline and received at least 1 dose of the randomized investigational drug (CP-690,550 5mg BID or 10 mg BID) during Period A.||weeks||95% Confidence Interval|Median
62415|NCT01186744|Primary|Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 4, 8, and 16 (Period C)|The Period C-Full Analysis Set (FAS-C) included all FAS-B participants who were advanced to the re-treatment period (Period C) during the 16 weeks of Period B and had received at least one dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period C.||percentage of participants||95% Confidence Interval|Number
62416|NCT01186744|Primary|Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C||percentage of participants||95% Confidence Interval|Number
62417|NCT01186744|Primary|Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 12, and 16 (Period B)|FAS-B||percentage of participants||95% Confidence Interval|Number
75239|NCT01054625|Secondary|Apparent Volume of Distribution During the Terminal Phase||8 weeks|||L||Geometric Coefficient of Variation|Geometric Mean
62418|NCT01186744|Primary|Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.|Weeks 4, 8 12, and 16 (Period B)|The Period B-Full Analysis Set (FAS-B) included all participants who were re-randomized at the end of Period A and received at least 1dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) or placebo at the beginning of Period B.||percentage of participants||95% Confidence Interval|Number
62419|NCT01186705|Primary|Overall Objective Response Rate (ORR)|in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)|1 year|||participants|||Number
62420|NCT01186692|Secondary|Changes in NYHA Functional Classification|Change in NYHA functional class from pre-implant to 6 month post-implant|6 Months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable paired NYHA data were included in the analysis.||participants|||Number
62421|NCT01186692|Secondary|Serious Device-related Adverse Events|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|6 months|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.||percentage of patients|||Number
62422|NCT01186692|Secondary|Serious Procedural Adverse Events|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|6 Months|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.||percentage of patients|||Number
62423|NCT01186692|Secondary|Procedural Success|"Procedural success is defined as a composite of the following:~The TPV is fixated within the desired location, and~The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and~There is no more than trivial pulmonary regurgitation by angiography~The subject is free from explantation of the TPV at 24 hours post-implant"|6 Months|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).||percentage of patients|||Number
62424|NCT01186692|Primary|Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation|"Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:~Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and~Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and~Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.~The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation."|6 months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable echo data at 6 months post implant were included in the analysis.||percentage of patients||95% Confidence Interval|Number
62425|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous glucose tolerance test|18 months|||ng/dL*min||Standard Error|Mean
62426|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous gluocose tolerance testing|12 months|||ng/dL*min||Standard Error|Mean
62427|NCT01186562|Secondary|AUC C-peptide|AUC C-peptide (ng/dL*min) from mixed meal tolerance test|18 months|||ng/dL*min||Standard Deviation|Mean
62428|NCT01186562|Secondary|Area Under the Curve (AUC) C-peptide (ng/dL*Min)|AUC C-peptide obtained from a mixed meal test|12 months|||ng/dL*min||Standard Error|Mean
62429|NCT01186562|Secondary|Insulin Independence|proportion of patients insulin independent|18 months|||percentage of participants|||Number
62430|NCT01186562|Primary|Insulin Independence|proportion of patients insulin independent|12 months|||percentage of participants|||Number
62431|NCT01186458|Secondary|Biologic Interaction|To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.|||||
62432|NCT01186458|Secondary|Toxicity|To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.|6 months|||number of adverse events|||Number
62433|NCT01186458|Secondary|Survival|To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.|||||
62434|NCT01186458|Primary|Overall Response Rate|To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.|6 months|Data for this primary objective was not collected or analyzed due to the termination of the study.|||||
62435|NCT01186419|Secondary|Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|92 weeks|PK Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.||ng*hr/ml||Standard Deviation|Mean
62911|NCT01181011|Secondary|Time to Attain Cmax (Tmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Telmisartan||h||Standard Deviation|Mean
62439|NCT01186406|Secondary|Median Progression-free Survival|Progression-free survival was defined as the time in months from the date study treatment started until the date of progression or the date of death if death occurred before progression, or until the date of last follow-up if alive without progression. Kaplan-Meier methods were used to estimate progression-free survival.|21 months|Intent-to-treat||months||95% Confidence Interval|Median
62440|NCT01186406|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat||months||95% Confidence Interval|Median
62441|NCT01186406|Primary|21-month Overall Survival|The percentage of participants alive at 21 months after the start of study treatment. Overall survival was calculated from the date study treatment started until the date of death or the date of last follow-up if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
62442|NCT01186250|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year|measure of low levels of C-reactive protein to identify low but persistent levels of inflammation|Baseline and 1 year|participant drop put||mg/L||Standard Deviation|Mean
62443|NCT01186250|Secondary|Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.|Competitive ELISA assay in Stanford laboratory.|Baseline and 1 year|One participant in one arm did not have Baseline or one year data.||umol/L||Standard Deviation|Mean
62444|NCT01186250|Secondary|Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)|The change in maximal intimal thickness (MIT) from baseline to one year was recorded for several matched sites in the same coronary artery, the cross sections, predominantly in the left anterior descending coronary artery, from baseline to one-year follow-up, were studied. The IVUS cross sections were matched by using identifiable landmarks in the images, such as bifurcations or arterial calcification, or external landmarks, such as coronary veins or pericardium. In addition, the one-year IVUS studies were obtained with an angiographic roadmap of where the initial IVUS study was performed along the length of the vessel. The IVUS system auto pullback was performed at .5 mm/s from the mid-distal portion of the study vessel, where an easily identifiable landmark was visible (i.e., branchpoint). The following items were measured for each patient: maximal intimal thickness (MIT), intimal area (IA), and vessel area.|Baseline and 1 year|number participants analyzed contained drops out due to clinical reasons||mm||Standard Deviation|Mean
62445|NCT01186250|Secondary|Change From Baseline in TG/HDL Ratio at One Year|Triglyceride ratio to High Density Lipoprotien|Baseline and 1 year|One drop out||ratio||Standard Deviation|Mean
62446|NCT01186250|Secondary|Change in Levels of Fasting Glucose at Baseline and 1 Year|Oral Glucose Tolerance Test : blood was drawn for fasting plasma glucose and insulin levels, followed by ingestion of a solution containing 75grams of glucose. Repeat blood samples were collected for glucose and insulin levels at 30, 90, and 120 minutes after glucose ingestion. All glucose measurements were performed by the Clinical Translational Research Unit (CTRU) Stanford University.|Baseline and 1 year|One participant in each group did not complete the OGTT.||mg/dL||Standard Deviation|Mean
62447|NCT01186250|Secondary|Change in Intimal Volume|Intimal volume is defined as external elastic membrane volume minus lumen (luminal) volume measured at the heart Catheterization and intravascular Ultrasound( IVUS)|baseline and 1 year|The number of participants enrolled were not all included in the intimal volume analysis because the Angiographic diagnostic evaluation needed for intimal volume measurement was clinically inappropriate for 3 in the pioglitazone arm and 5 in the Placebo arm at 12 months post transplant.||mm^3||Standard Deviation|Mean
62448|NCT01186250|Primary|Insulin Levels Area Under Curve(AUC)|Change from baseline in Insulin Levels During Oral Glucose Tolerance test at 1 year.|Baseline and 1 year|||h*pmol/L||95% Confidence Interval|Mean
62449|NCT01185834|Secondary|Overall Lens Fit|As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale|Participants|Standard Deviation|Mean
62450|NCT01185834|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
62451|NCT01185782|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment period to post-treatment assessment period (Day 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.||participants|||Number
62452|NCT01185782|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the IMP. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants who discontinued from the study due to AE were also recorded.|Pretrial observation period to post-treatment assessment period (Days 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.||participants|||Number
62465|NCT01185704|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus.|Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||transferred embryos||Standard Deviation|Mean
75240|NCT01054625|Secondary|Clearance||8 weeks|||L/h||Geometric Coefficient of Variation|Geometric Mean
62453|NCT01185782|Secondary|Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy|For this secondary endpoint, participants were considered to have ovulated if serum P4 level was more than or equal to 10 ng/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 during post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent ovulation|||Number
62454|NCT01185782|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Day 35-42 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent clinical pregnancy|||Number
62455|NCT01185782|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy was defined as a positive pregnancy test (urinary beta-hCG test) on Day 28-31 of the post-treatment assessment period|Day 28-31 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent biochemical pregnancy|||Number
62456|NCT01185782|Secondary|Single Follicle Maturation Rate|Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent single follicle maturation|||Number
62457|NCT01185782|Secondary|Human Chorionic Gonadotropin (hCG) Cancellation Rate|hCG cancellation criterion was defined as the presence of 4 or more ovarian follicles with a mean diameter greater than or equal to 16 mm. If the hCG cancellation criterion was met, the administration of hCG was withheld. Otherwise, a single intramuscular dose of hCG 5000 IU (Japanese Pharmacopoeia- JP) was administered within 24 hours of the last ultrasound examination.|Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||percent hCG cancellation|||Number
62458|NCT01185782|Secondary|Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter|Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter.||IU||Standard Deviation|Mean
62459|NCT01185782|Secondary|Time for Dominant Follicle to Achieve 18 mm in Mean Diameter|Dosing time length was calculated as number of days from the first administration of the IMP until the mean diameter of the dominant follicle was confirmed to have reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis.||days||Standard Deviation|Mean
62460|NCT01185782|Secondary|Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter||Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.||participants|||Number
62461|NCT01185782|Primary|Percentage of Participants With Ovulation|Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]|Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.||percentage of participants|||Number
62462|NCT01185704|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.|Day 1 up to end of study (15 days post last administration of study drug)|||participants|||Number
62463|NCT01185704|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||percentage of participants|||Number
62464|NCT01185704|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent sacs per embryo|||Number
62728|NCT01182428|Secondary|Clinical Procedure Success|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.|Intra-operative|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
62466|NCT01185704|Secondary|Number of Blastocysts|Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.|Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||blastocysts||Standard Deviation|Mean
62467|NCT01185704|Secondary|Number of Embryos|Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.|Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||embryos||Standard Deviation|Mean
62468|NCT01185704|Secondary|Percentage of Fertilized Oocytes Retrieved|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent fertilized oocytes||Standard Deviation|Mean
62469|NCT01185704|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||international unit (IU)||Standard Deviation|Mean
62470|NCT01185704|Secondary|Number and Quality of Oocytes Retrieved|Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||oocytes||Standard Deviation|Mean
62471|NCT01185704|Secondary|Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||follicles||Standard Deviation|Mean
62472|NCT01185704|Secondary|Anti Mullerian Hormone (AMH) Levels||Day 0|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
62473|NCT01185704|Secondary|Serum Progesterone (P4) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanomolar/liter (nmol/L)||Standard Deviation|Mean
62474|NCT01185704|Secondary|Serum Estradiol (E2) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
62475|NCT01185704|Secondary|Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels||Day 1|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Here n signifies those participants who were evaluated for specified category."||International unit/liter (IU/L)||Standard Deviation|Mean
62476|NCT01185704|Primary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|"Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||picogram/milliliter (pg/mL)||Standard Deviation|Mean
62477|NCT01185600|Secondary|Each Participant's Number of Non-serious Adverse Events|All clinical non-serious adverse events reported in the clinical chart were recorded in the study's data files. This type of events, defined as Non-Serious Adverse Events or just Adverse Events (AEs) were categorized into 5 groups: (1) Cardiovascular / respiratory; (2) renal; (3) neurologic (CNS); (4) infections; and (5) other. For each participant, the outcome measure was defined as the number of AE's he or she experienced during his/her hospital stay.|Within 30 days after CABG surgery|||Mean of number of AE's||Standard Deviation|Mean
62478|NCT01185600|Primary|Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD235a+ red cell microparticles between at 1 hour post-surgery and at pre-surgery, i.e. levels at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|||counts / uL||Standard Deviation|Mean
62479|NCT01185600|Primary|Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD62E+ endothelial microparticles between 1 hour post-surgery and at pre-surgery, i.e. level at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."||counts / uL||Standard Deviation|Mean
62480|NCT01185600|Primary|Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery|Difference in levels of circulating Annexin V+ microparticles between at pre-surgery and 1 hour post-surgery, i.e. level of Annexin V+ microparticles at 1 hour post-surgery - level of Annexin V+ microparticles at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."||counts / uL||Standard Deviation|Mean
62530|NCT01185249|Primary|The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients||Mean differences in the morning (5am) weights compared for three consecutive days. Day 1, Day 2, Day 3. Mean difference in the morning (5am) and evening (8pm) weights for three consecutive days. Day 1, Day 2, Day 3.|Patients with three consecutive days of morning and evening weights.||kilograms||Standard Deviation|Mean
62481|NCT01185600|Primary|Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD41+ platelet microparticles between at pre-surgery and at 1hour post-surgery, i.e. level at 1hour post-surgery - level at pre-surgery|interval between presurgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."||counts / uL||Standard Deviation|Mean
62482|NCT01185600|Primary|Occurrence of at Least One Serious Adverse Event (SAE)|Comparison of the two groups with respect to occurrence or not of at least one SAE including sepsis, respiratory failure, multi-organ failure, anaphylactic shock, transfusion-related acute lung injury, MI, stroke, cardiac arrest.|within 30 days after CABG surgery|||participants|||Number
62483|NCT01185600|Primary|One-year Mortality|Number participants who expired within one year after CABG surgery|Within one year after CABG surgery|During the 12 months after hospital discharge, one participant in the group of transfusion with washed RBC and 3 participants in the group of transfusion with unwashed RBC were lost to follow up.||participants|||Number
62484|NCT01185600|Primary|In Hospital Mortality|The number of participants who expired during hospital stay after CABG surgery|Within 30 days after CABG surgery|||participants|||Number
62485|NCT01185561|Secondary|State–Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score|Scores on the The State–Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
62486|NCT01185561|Secondary|State–Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score|Scores on the The State–Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
62487|NCT01185561|Secondary|State–Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score|Scores on the The State–Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
62488|NCT01185561|Primary|Center for Epidemiologic Studies Depression (CES-D) Score|The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.||units on a scale||Standard Deviation|Mean
62489|NCT01185522|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 4 months|Safety population consisted of all participants included in the study, who respected the inclusion and non-inclusion criteria and who at least one tocilizumab infusion.||Number of Participants|||Number
62490|NCT01185522|Secondary|Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4|Participants with tocilizumab treatment were managed according to number of tocilizumab treatment received according to Summary of Product Characteristics recommendations, as 8 mg/kg, dose duration of 1-hour, correct infusion progress; and received DMARD, methotrexate, and corticosteroids concomitantly with tocilizumab during Months 1 to 4.|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Number of Participants|||Number
62491|NCT01185522|Secondary|Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4|Fatigue was assessed by FACIT-Fatigue scale (ranging from 0 [worse score] to 52 [better score]) and VAS fatigue (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]). Other participant reported outcomes (PROs) were VAS for pain and quality of sleep (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]), SF36 vitality score (ranging from 0 [worst] to 100 [best]) and HAD score (calculated using the 14 items and each item was scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales were summed; each resulting in a total score of 0-21). Correlation between fatigue as assessed by FACIT-Fatigue score or VAS fatigue was evaluated for all participants using a linear regression and were reported for D0 and M4.|Day 0 and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Coefficient of correlation|||Number
62531|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.~Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15."|Baseline to 1st day of visit 15|||ratio||95% Confidence Interval|Least Squares Mean
62492|NCT01185522|Secondary|Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4|FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), VAS (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]) and SF36 vitality score (ranging from 0 [worst] to 100 [best]) were calculated at Baseline and Month 4.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Percentage of participants|||Number
62493|NCT01185522|Secondary|Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4|A PASS score at Day 0 and Month 4 calculated on participants with acceptable symptom state. PASS is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.||Number of participants|||Number
62494|NCT01185522|Secondary|Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and CRP value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. CRP values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in CRP level up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.||Percent change||Full Range|Median
62495|NCT01185522|Secondary|Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and ESR value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. ESR values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in ESR values up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.||Percent change||Full Range|Median
62496|NCT01185522|Secondary|Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4|"Relative change (RC) from Baseline (BL) in disease activity included TJC and SJC was evaluated as continuous variables for all participants at each evaluation time points.~For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in TJC and SJC up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.||Percent change||Full Range|Median
62497|NCT01185522|Secondary|Relative Median Change From Baseline in DAS 28 and VAS Patient’s Global Assessment to Month 1, Month 2, Month 3, and Month 4|Relative change from Baseline (BL) in DAS 28 was evaluated for all participants at each evaluation time (on raw data at inclusion; at Month 1, Month 2, Month 3, and Month 4 using a linear regression. DAS-28 and VAS patient’s global assessment (PGA) were described as continuous variables for all participants at each evaluation time points (Baseline to M4). DAS 28 ranging from 0 (no disease activity) to 10 (worsening in disease activity) and VAS PGA ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening of symptoms and arthritis disease activity),|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in DAS 28 up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.||Percent change||Full Range|Median
62498|NCT01185522|Secondary|Median Time to Onset of an Improvement of the FACIT-Fatigue Score|The time of onset of a clinically significant improvement of fatigue was defined as the time between the date of the first tocilizumab infusion and the date of the first increase of at least 4 points of the FACIT-Fatigue score (date of questionnaire completion) during 4 months of tocilizumab treatment. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score).|Up to Month 4|Patient analysis population was considered. Participants with increase of at least 4 points of the FACIT-Fatigue score were analyzed for this outcome measure.||Months||95% Confidence Interval|Median
62512|NCT01185301|Secondary|Percentage of Participants With No Radiographic Progression at Week 26|“No radiographic progression” was defined as a change from Baseline in modified Total Sharp Score (mTSS) at Week 26 of ≤ 0.5. mTSS is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
75241|NCT01054625|Secondary|Elimination Half-life||8 weeks|||h||Geometric Coefficient of Variation|Geometric Mean
62499|NCT01185522|Secondary|Correlation Between Relative Changes From Baseline of FACIT-Fatigue Score and VAS Fatigue to 4 Months of Tocilizumab Treatment|Correlation between FACIT-Fatigue score and VAS fatigue was evaluated for all participants at inclusion and after 4 months of tocilizumab treatment (relative change from baseline) using a linear regression. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity)|From Baseline (D0) to Month (M) 4|Patient analysis population was considered. Participants with Changes in FACIT-Fatigue Score and VAS Fatigue at Month 4 were analyzed for this outcome measure.||Correlation Coefficient|||Number
62500|NCT01185522|Primary|Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment|"Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen.~For tender joint count (TJC), a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.~For swollen joint count (SJC), a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.||Number of joints||Standard Deviation|Mean
62501|NCT01185522|Primary|Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment|Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. C-reactive protein (CRP) is one of the biomarkers for the diagnosis and assessment of disease activity in RA.|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.||milligram per liter||Inter-Quartile Range|Median
62502|NCT01185522|Primary|Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors|Predictive factors of fatigue were taken into account included gender, age, time since initial diagnosis, Erosive RA, disease activity score (DAS, ranging from 0 [no disease activity] to 10 [worsening in disease activity]), erythrocyte sedimentation rate (ESR), anemia, treatment with corticosteroids, doses of corticosteroids, health assessment questionnaire (HAQ, ranging from 0 [without any difficulty] to 60 [worsening or unable to do physical activities]), FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), visual analogue score (VAS) for fatigue, pain, quality of sleep, and global assessment (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]), Short Form 36 (SF36) vitality score (ranging from 0 [worst] to 100 [best]), Hospital Anxiety and Depression Scale (HADS; represented as score </= 7 [no case], 7 to 10 [doubtful case], and > 10 [certain case of HAD]).|At Month 4|Patient analysis population was considered. Participants whom baseline characteristics were available at inclusion and who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.||Number of participants|||Number
62503|NCT01185522|Secondary|Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score|FACIT-fatigue score and VAS fatigue score were fatigue assessment parameters. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranges from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Clinically relevant improvement is defined as >/= 4-point change from Baseline.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular time fatigue scores.||Scores on a scale||Standard Deviation|Mean
62504|NCT01185522|Secondary|Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue|High Erythrocyte Sedimentation Rate (ESR) was defined as (1) for participants aged up to 50 years: > 15 mm/h for men and > 20 mm/h for women, and (2) for participants aged over 50 years: > 20 mm/h for men and > 25 mm/h for women. Anemia was defined as plasma hemoglobin level <12 gram per deciliter (g/dL) for women and <13 g/dL for men. The CRP test is evaluated for an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Patient-Acceptable Symptom State (PASS) that is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.||Number of participants|||Number
62729|NCT01182428|Secondary|Clinical Device Success|Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.|Intra-operative|Based on Intent to Treat (ITT) population.||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
62505|NCT01185522|Secondary|Baseline Disease Characteristic: DAS28, Patient’s Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters|DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/h), and patient's global assessment of disease activity (measured on a 100-mm visual analog scale, where 0 is no disease activity and 100 is maximum disease activity). The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening disease activity. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain. HAQ indicates how the disease affected participant’s activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.||Scores on a scale||Standard Deviation|Mean
62506|NCT01185522|Secondary|Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count|"For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.~For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Tender joint count and swollen joint count were assessed at baseline and were used as baseline disease characteristics for assessment of rheumatoid arthritis."|Baseline (D0)|Patient analysis population was considered. n = number of participants available for particular parameters.||Number of joints||Standard Deviation|Mean
62507|NCT01185522|Secondary|Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies|Blood was collected for Rheumatoid Factor (RF) at Baseline and was analyzed. RF level was reported in international units/milliliter (IU/mL). All participants were assessed for anti-cyclic citrullinated protein (anti-CCP) antibodies at baseline. Number of participants with a positive RF and/or anti-CCP antibodies were reported as baseline disease characteristics.|Baseline (D0)|Patient analysis population was considered. Participants with positive RF and/or anti-CCP antibodies at baseline were analyzed for this outcome measure.||Number of Participants|||Number
62508|NCT01185522|Secondary|Baseline Disease Characteristics: Mean Disease Duration|Mean disease (rheumatoid arthritis) duration at inclusion was recorded for all participants as baseline disease characteristics.|Baseline (Day [D] 0)|Patient analysis population was considered. Participants for whom data of disease duration was available at baseline were analyzed for this outcome measure.||years||Standard Deviation|Mean
62509|NCT01185522|Primary|Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment|"Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale: 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses resulted a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant’s health status. Clinically relevant improvement is defined as a >= 4-point change from Baseline.~This was performed using the last observation carried forward (LOCF) method and for participants who completed a FACIT-Fatigue score at Month 4 (completers)."|At Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment.||Percentage of participants||95% Confidence Interval|Number
62510|NCT01185301|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26|CDAI is a measure of disease activity derived as follows: CDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]). CDAI total score = 0 to 76. CDAI ≤ 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, > 10 to 22 = moderate disease activity, and > 22 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62511|NCT01185301|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26|SDAI is a measure of disease activity derived as follows: SDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) + CRP (mg/dL), where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]), and CRP is C-reactive protein measured in mg/dL. SDAI total score = 0 to 86. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62521|NCT01185301|Secondary|Percentage of Participants With DAS28(CRP) Remission at Week 26|Disease remission was defined as a disease activity score, based on CRP, for 28 joints that was < 2.6 (DAS28[CRP] < 2.6). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62513|NCT01185301|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26|The modified Total Sharp Score (mTSS) is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 26|Intent-to-Treat population with available data at time point (observed cases).||score on a scale||Standard Deviation|Mean
62514|NCT01185301|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ –0.22 at Week 26|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from Baseline of ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62515|NCT01185301|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population with non-missing baseline and at least 1 non-missing post-baseline value (baseline is defined as the last non-missing value prior to the first dose of study drug); last observation carried forward.||units on a scale||Standard Deviation|Mean
62516|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26|"Response, as defined by ACR 100 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 100% improvement in tender joint count; ≥ 100% improvement in swollen joint count; and ≥ 100% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62517|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26|"Response, as defined by ACR 90 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62518|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26|"Response, as defined by ACR 70 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62519|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26|"Response, as defined by ACR 50 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62520|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26|"Response, as defined by ACR 20 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62708|NCT01182428|Secondary|In-stent Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||% diameter stenosis|Participants|Standard Deviation|Mean
62522|NCT01185301|Primary|Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26|Percentage of participants achieving low disease activity as defined by a clinical response (DAS28[CRP] < 3.2). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.||percentage of participants|||Number
62523|NCT01185288|Other Pre-specified|Serum Adalimumab Trough Concentrations at Week 24|Serum trough concentrations of adalimumab assessed at week 24 (24 weeks after the 1st dose).|Week 24|All participants with available pharmacokinetics at week 24: For Adalimumab + Low Dose Methotrexate, n = 134; for Adalimumab + High Dose Methotrexate, n = 140.||µg/mL||Standard Deviation|Mean
62524|NCT01185288|Secondary|Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24|The least squares mean percentage change in MOS Sleep Problem Index 9 from baseline to week 24. The MOS Sleep Problem Index 9 consists of 9 questions to assess sleep, including how long it takes the participant to fall asleep (1=0 to 15 minutes, to 5=more than 60 minutes); and aspects of related to quality of sleep, including how often the participant felt that the sleep was not quiet, felt rested upon waking, awakened short of breath or with a headache, felt drowsy during the day, had trouble falling sleep, how often were awaken, had trouble staying awake during the day, and got needed amount of sleep (1=all the time; 5=none of the time). Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline MOS Sleep Problem Index value, treatment group, and prior methotrexate dose group.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percent change||95% Confidence Interval|Least Squares Mean
62525|NCT01185288|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high dependency disability). The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from baseline of ≤ -0.22. Normal physical function is defined by HAQ-DI score of < 0.5. Negative change from baseline in the overall score indicates improvement.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
62526|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24|Response, as defined by ACR70 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
62527|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24|Response, as defined by ACR50 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
62528|NCT01185288|Secondary|Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24|PD U/S assessed the severity of synovial inflammation in both hands (bilateral wrists, metacarpophalangeal joints 2, 3, 5, and metatarsophalangeal joint 5). Bilateral images based on dorsal midline imaging of the wrist, dorsal and volar imaging of metacarpophalangeal joints, and dorsal imaging alone of metatarsophalangeal joints are scored using a 4-grade scale: grade 0 or normal = normal joint (no Doppler signal); grade 1 or mild = mild synovitis (≤ 3 isolated signals); grade 2 or moderate = moderate synovitis (> 3 isolated signals or a confluent signal in < 50% of synovial area); grade 3 or marked = marked synovitis (signals in ≥ 50% of the synovial area). Each image is rated 0 to 3, for a total possible score ranging from 0 to 48 (16*0, 16*3) for 2 hands. Higher grade/score=more severe disease. Change = week 24 score - baseline score.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).||percentage of participants|||Number
62529|NCT01185288|Primary|Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24|The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score < 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.|Week 24|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed using last observation carried forward (LOCF).||scores on a scale||95% Confidence Interval|Least Squares Mean
75242|NCT01054625|Secondary|Area Under Curve 0-21 Days||0-21 days|||h mg/L||Geometric Coefficient of Variation|Geometric Mean
62532|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.~Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15."|Baseline to 1st day of visit 15|||ratio||95% Confidence Interval|Geometric Mean
62533|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)|||L/min||Standard Deviation|Mean
62534|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)|||L/min||Standard Deviation|Mean
62535|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)|||Scores on a scale||Standard Deviation|Mean
62536|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)|||Scores on a scale||Standard Deviation|Mean
62537|NCT01185080|Primary|of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
62538|NCT01185080|Primary|Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
62539|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
62540|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.|||L/min||Full Range|Least Squares Mean
74602|NCT01062763|Primary|Change of of Systolic Blood Pressure|Change of systolic blood pressure from baseline to study end at four months.|4 months|Analysis by intention to treat using LOCF||mm Hg||95% Confidence Interval|Mean
62541|NCT01185080|Primary|Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
62542|NCT01185080|Primary|Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
62543|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
62544|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.|||Scores on a scale||Full Range|Least Squares Mean
62545|NCT01185028|Primary|Number of Participants With Adverse Events|Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.|2 years|||adverse events|||Number
62546|NCT01185028|Secondary|Tolerability|Proportion of individuals that discontinued study drug|2 years||||||
62547|NCT01185028|Secondary|Sustained Viral Response Rate|Proportion of participants that are HCV negative 6 months after treatment completion|72 weeks|||participants|||Number
62548|NCT01184989|Primary|Dabigatran Concentration in Plasma, Measured With HPLC-MS/MS|Dabigatran Concentration in Plasma, measured with HPLC-MS/MS - Most relevant timepoints are reported here, ie timepoints of day 6|At day 6 before drug intake (di), at 1h, 2h, 4h, 8h and 24h after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting||ng/mL||Geometric Coefficient of Variation|Geometric Mean
62549|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Central Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured centrally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting||measurements estimated as above LLOQ|Participants||Number
62581|NCT01184846|Secondary|Mean Change in Pulse Rate During Infusion|Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug||beats per minute||Standard Deviation|Mean
62550|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Local Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured locally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting||measurements estimated as above LLOQ|Participants||Number
62551|NCT01184898|Secondary|Partial Response|"Partial response is defined as:~Requires that all of the criteria for complete remission be satisfied except that the bone marrow may contain ≥ 5% blasts but < 25% blasts.~A marrow with <5% blasts that contain Auer rods will also be considered a PR"|Within one week of peripheral count recovery but no later than day 42|||participants|||Number
62552|NCT01184898|Secondary|Complete Response in the Absence of Platelet Recovery|"Complete response in the absence of platelet recovery is defined as:~- Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)"|Within one week of peripheral count recovery but no later than day 42|||participants|||Number
62553|NCT01184898|Secondary|Complete Response|"Complete response is defined as:~Peripheral Blood Counts -Neutrophil count >1 x 109/L.~Platelet count ≥ 100 x 109/L.~Reduced hemoglobin concentration or hematocrit has no bearing on remission status.~Leukemic blasts must not be present in the peripheral blood.~Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines with < 5% blasts and no Auer rods.~Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present"|Within one week of peripheral count recovery but no later than day 42|||participants|||Number
62554|NCT01184898|Primary|Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC|"Percent change compared between response groups (responder vs nonresponder).~This outcome measure only includes patients who survived to outcome assessment."|From pre- to post-treatment|||percentage change in leukemic blasts||Full Range|Mean
62555|NCT01184885|Secondary|Complete Response|"To describe response rates to hyper-CVAD and sirolimus in adults with ALL and other aggressive lymphoid malignancies.~Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)."|Every 21 days or as count recovery allows (at least 14 days apart) up to 24 weeks|||participants|||Number
62556|NCT01184885|Secondary|Induction Mortality|Induction mortality. Hyper-CVAD/ Rapamycin will be considered acceptable if induction mortality does not exceed 31% in patients older than 60, or 15% in those younger than 60|18 months||||||
62557|NCT01184885|Primary|Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival|"This will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of > 0.5 x 10^9/L and platelet count > 50 x 10^9/L.~Hyper-CVAD/Rapamycin will be deemed acceptable if it is feasible to administer in 80% or more of subjects."|18 months|||participants|||Number
62558|NCT01184872|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||Continuously from baseline up to 28 days after end of antibiotic treatment.|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.||participants|||Number
62559|NCT01184872|Secondary|Duration of Treatment (Intravenous and Oral)|Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis set (FAS) comprised all patients to whom study treatment had been assigned at randomization.||Days||Standard Deviation|Mean
62560|NCT01184872|Secondary|Duration of Treatment (Intravenous)|Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned at randomization.||Days||Standard Deviation|Mean
62561|NCT01184872|Secondary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.|Baseline and 7 to 14 days after end of therapy|Population analyzed consisted of patients from the clinically evaluable population who had independent microbiological assessments.||participants|||Number
62594|NCT01184417|Secondary|Number of Study Patients With Seizure as a Measure of Safety and Tolerability|Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).|1 year|||participants|||Number
75243|NCT01054625|Secondary|Area Under Curve 0-7 Days||0-7 days|||h mg/L||Geometric Coefficient of Variation|Geometric Mean
62562|NCT01184872|Primary|Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit|Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.|Baseline and 7 to 14 days after end of therapy|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for complicated skin and soft tissue, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.||participants|||Number
62563|NCT01184859|Secondary|Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)|Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.|Days 4- 32|Safety population which included all randomised and exposed participants. Participants were analysed according to the actual treatment received.||participants|||Number
62564|NCT01184859|Secondary|Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32|The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||units on a scale||Standard Deviation|Mean
62565|NCT01184859|Secondary|Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32|N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||units on a scale||Standard Deviation|Mean
62566|NCT01184859|Secondary|Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32|Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||nocturnal urine volume / 24-hour urine||Standard Deviation|Mean
62567|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||ml/kg||Standard Deviation|Mean
62568|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Volume at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||ml||Standard Deviation|Mean
62569|NCT01184859|Secondary|Change From Baseline in Nocturnal Urine Volume at Approximately Day 32|Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||ml||Standard Deviation|Mean
62595|NCT01184417|Secondary|Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability|"Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a bedside sitter to observe the patient and provide additional safety supervision during any portion of their hospitalization."|1 year|||percentage of participants|||Number
62570|NCT01184859|Secondary|Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32|Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||voids||Standard Deviation|Mean
62571|NCT01184859|Secondary|Change From Baseline in Number of Daytime Voids at Approximately Day 32|Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||voids||Standard Deviation|Mean
62572|NCT01184859|Secondary|Change From Baseline in Total Sleep Time at Approximately Day 32|"Total sleep time is defined as the time spent asleep from initial sleep to final awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||minutes||Standard Deviation|Mean
62573|NCT01184859|Secondary|Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2|"Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||minutes||Standard Deviation|Mean
62574|NCT01184859|Secondary|Time When Urine Production <0.12 ml/kg/Min|Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||hours||Standard Deviation|Mean
62575|NCT01184859|Secondary|Area Under the Urine Production Curve (AUCurine Prod)|Area under the urine production curve, from dose administration to end of action (AUCurine prod)|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||h*mL||Standard Deviation|Mean
62576|NCT01184859|Secondary|Area Under the Urine Osmolality Curve (AUCosm)|Area under the urine osmolality curve, from dose administration to end of action (AUCosm).|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||h*mOsm/kg||Standard Deviation|Mean
62577|NCT01184859|Primary|Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2|Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.||nocturnal voids||95% Confidence Interval|Least Squares Mean
62578|NCT01184859|Primary|Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1|Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.||hours||Standard Deviation|Mean
62579|NCT01184846|Secondary|Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.|Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint.|At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)|The SDS comprised all subjects treated with the study drug.||participants|||Number
62580|NCT01184846|Secondary|Mean Change in Body Temperature During Infusion|Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.||°C||Standard Deviation|Mean
62582|NCT01184846|Secondary|Mean Change in Systolic and Diastolic Blood Pressure During Infusion|Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.||mm Hg||Standard Deviation|Mean
62583|NCT01184846|Secondary|Relatedness of AEs Per Subject|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.||percentage of subjects|||Number
62584|NCT01184846|Secondary|Relatedness of AEs Per Infusion|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.||AE rate per infusion|Participants||Number
62585|NCT01184846|Secondary|Severity of AEs Per Subject|"The severity of each AE was to be graded by the investigator as follows:~Mild: Symptoms were easily tolerated and there was no interference with daily activities.~Moderate: Discomfort enough to cause some interference with daily activities.~Severe: Incapacitating with inability to work or do usual activity."|34 weeks|The SDS comprised all subjects treated with the study drug.||percentage of subjects|||Number
62586|NCT01184846|Secondary|Severity of AEs Per Infusion|"The severity of each AE was to be graded by the investigator as follows:~Mild: Symptoms were easily tolerated and there was no interference with daily activities.~Moderate: Discomfort enough to cause some interference with daily activities.~Severe: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.||AE rate per infusion|Participants||Number
62587|NCT01184846|Secondary|Frequency of Adverse Events (AEs)|Overall rate of AEs per infusion.|For the duration of the study, up to 34 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.||AE rate per infusion|Participants||Number
62588|NCT01184846|Secondary|Immunoglobulin G (IgG) Level||At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement.||mg/dL||Standard Deviation|Mean
62589|NCT01184846|Secondary|Change in Medical Research Council Sum Scale (MRC)|"The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.~The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.||score on a scale||95% Confidence Interval|Mean
62590|NCT01184846|Secondary|Change in Maximum Grip Strength|Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement.|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.||kPa||95% Confidence Interval|Mean
62591|NCT01184846|Secondary|Change in Adjusted INCAT Score|"The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.~The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates ‘no upper limb problems’ and arm = 5 indicates ‘inability to use either arm for any purposeful movement’, and leg = 0 indicates ‘walking not affected’, and leg = 5 indicates ‘restricted to wheelchair, unable to stand and walk a few steps with help’). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.||score on a scale||95% Confidence Interval|Mean
62592|NCT01184846|Primary|Responder Rate|"Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score.~Responders were defined as those subjects who: 1) demonstrated a “clinically meaningful improvement” between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with “clinically meaningful improvement” at the last study visit.~Clinically meaningful improvement” was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0."|25 weeks|The full analysis set (FAS) includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. The valid cases set (VCS) consists of all FAS subjects without any major protocol deviation (ie, the subjects who participated in the study as intended).||percentage of responders||95% Confidence Interval|Number
62593|NCT01184417|Secondary|Number of Study Patients With Mortality as a Measure of Safety and Tolerability|mortality in study patients|1 year|||participants|||Number
62600|NCT01184417|Primary|Number of Patients Requiring Continuous Lorazepam Infusion|"All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or lorazepam drip). Thus, continuous lorazepam infusion is a yes or no variable (i.e. continuous infusion, or not)."|1 year|||participants|||Number
62601|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment.|The Iowa Oral Performance Instrument (IOPI) will be used. This instrument has a standard-sized air-filled polymer balloon, called tongue sensor or bulb, which can be inserted between the tongue blade and the roof of the mouth. Anterior tongue strength (KPa) reported. Subjects were divided into 3 subgroups: improved (lower anterior tongue strength KPa), unchanged, or worsened (higher anterior tongue strength KPa).|16 weeks|||participants|||Number
62602|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Secondary goals include evaluating effects of this medication on severity of obstructive sleep disordered breathing (SDB) (validated by Sleep Disorders Questionnaire (SA-SDQ)). Subjects were divided into 3 subgroups: improved (less negative SA-SDQ score), unchanged, or worsened (more negative SA-SDQ score).|16 weeks|||participants|||Number
62603|NCT01184118|Primary|Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Upper airway (UAW) collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes. Subjects were divided into 3 subgroups: improved (more negative Pcrit), unchanged, or worsened (less negative Pcrit).|16 weeks|||participants|||Number
62604|NCT01184079|Secondary|Safety Profile|Total proportion of side effects reported after any dose, compared by arm.|1 week after vaccination|Intention-to-treat||percentage of doses with side effects|||Number
62605|NCT01184079|Secondary|Compliance With 3rd Dose|Determine the compliance of the men for the timing of the third dose.|at 3rd dose (i.e., at month 6 or month 12, depending on arm)|||participants|||Number
62606|NCT01184079|Primary|Immunogenicity After Dose 3|Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.|1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)|Intention-to-treat||mM units/ml||95% Confidence Interval|Geometric Mean
62607|NCT01184014|Secondary|the Mean Blood Glucose of All Blood Glucose Readings|as stated above|starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days||||||
62608|NCT01184014|Primary|Mean Blood Glucose.|as stated above|discharge or until after their 5th day in the hospital|||mg/dL||Standard Deviation|Mean
62609|NCT01183975|Primary|Mean Excess Weight Change|Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).|3 years follow up|||percent change in excess weight||Standard Deviation|Mean
62610|NCT01183975|Primary|Mean BMI Change|Mean change in BMI for valid subjects|3 years follow-up|517 valid patients analyzed||kg/m^2||Standard Deviation|Mean
62611|NCT01183858|Secondary|Overall Survival (OS) at the End of Study|OS defined as the time from randomization to the date of death due to any cause.|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||months||95% Confidence Interval|Median
62612|NCT01183858|Primary|Progression-Free Survival (PFS) at the End of Study|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||weeks||95% Confidence Interval|Median
62613|NCT01183858|Secondary|Number of Participants With Adverse Events (AEs) at the End of the Study|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death."|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Safety population included all randomized participants who received at least one dose of study drug.||participants|||Number
62614|NCT01183858|Secondary|Time to Progression (TTP)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||weeks||95% Confidence Interval|Median
62912|NCT01181011|Primary|Cmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs|All patients with values for Cmax of Amlodipine||ng/mL||Geometric Coefficient of Variation|Geometric Mean
62615|NCT01183858|Secondary|Disease Control Rate (DCR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||percentage of participants||95% Confidence Interval|Number
62616|NCT01183858|Secondary|Overall Response Rate (ORR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||percentage of participants||95% Confidence Interval|Number
62617|NCT01183858|Secondary|Overall Survival (OS)|OS defined as the time from randomization to the date of death due to any cause.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||months||95% Confidence Interval|Median
62618|NCT01183858|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.||weeks||95% Confidence Interval|Median
62619|NCT01183780|Secondary|Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab||Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17|All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
62620|NCT01183780|Secondary|Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.|Cycles 1, 3, 5, and 30-Day FU|All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.||percentage of participants|||Number
62621|NCT01183780|Secondary|Change From Baseline in EuroQol- 5D (EQ-5D)|The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline and 30-Day Follow-Up (FU) up to 171 Weeks|All randomized participants who had EQ-5D assessed at baseline and 30-day FU.||units on a scale||Standard Deviation|Mean
62622|NCT01183780|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status|The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.|Baseline up to 171 Weeks|All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .||units on a scale||Standard Deviation|Mean
62623|NCT01183780|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.|Randomization until Disease Progression up to 38.01 Months|All randomized participants.||percentage of participants||95% Confidence Interval|Number
62636|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing multiple fraction treatment||percentage of participants|||Number
62624|NCT01183780|Secondary|Progression-free Survival (PFS) Time|PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.|Randomization to Measured PD or Date of Death from Any Cause up to 38.01 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.||months||95% Confidence Interval|Median
62625|NCT01183780|Primary|Overall Survival (OS)|OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.|Randomization to Date of Death from Any Cause up to 39.36 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.||months||95% Confidence Interval|Median
62626|NCT01183728|Secondary|Indication of Efficacy|"Clinical exploration, questionaires (VAS, WOMAC, Lequesne Index, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV.~Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.~Mean (SD) are expressed as the percent of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =5 is considered normal (can be attained by chance). Values above 5 are considered pathological. The worst possible is 100."|0, 6, 12, 24 months|||percentage of values||Standard Deviation|Mean
62627|NCT01183728|Primary|Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.|"Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index (questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)).~In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome.~VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities."|0, 3, 6, 12 and 24 months|||units on a scale||Standard Deviation|Mean
62628|NCT01183650|Primary|Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants||hours||Full Range|Median
62629|NCT01183650|Primary|Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
62630|NCT01183650|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710|AUC for Day 1 is reported as AUC(tau [t], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state [ss]), which is AUC during one 24-hour dosing interval at steady-state.|1 day and 10 days|All enrolled participants||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
62631|NCT01183546|Secondary|Shoulder Peak Resultant Moment|Shoulder Peak Resultant Moment during wheelchair transfers was calculated using an inverse dynamics model approach. Inputs into the model included forces recorded at the hands during transfers, three-dimensional motion trajectories of markers placed on the upper limbs and trunk, and subject's anthropometric data.|Baseline Testing and at Followup Testing (4 weeks)|||Newton-meter/kilogram||Standard Deviation|Mean
62632|NCT01183546|Primary|Transfer Performance (TAI Scores Part 1)|"Part 1 of the TAI is comprised of 15 items which are scored yes (1 point) when the subject performs the specified skill correctly and no (0 points) when the subject performs the skill incorrectly or (N/A) which means the item does not apply. The part 1 summary score is the summation of each item's score multiplied by 10, and then divided by the number of applicable items, ranging from 0 to 10."|Baseline Testing and at Followup Testing (4 weeks)|||units on a scale||Standard Deviation|Mean
62633|NCT01183533|Secondary|Mortality||90 days|Note: although 2 patients were not available for complete day 90 assessments, family/patient communication provided necessary mortality information.||participants|||Number
62634|NCT01183533|Secondary|90-day Modified Rankin Scale (mRS) Score 0 or 1|Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention.|90 days|^ Note: 2 patients were not available for 90-day follow-up assessments.||participants|||Number
62635|NCT01183533|Primary|Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients|The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.|24 hours|||cases.|||Number
62913|NCT01181011|Primary|AUC_0-∞ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Amlodipine||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
62637|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed.~Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame."|During radiotherapy (5 days) and the 24 hours following radiotherapy|Patients undergoing multiple fraction treatment||percentage of participants|||Number
62638|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing single fraction treatment||percentage of participants|||Number
62639|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries."|Day of radiotherapy and 24 hours following|Patients undergoing single fraction treatment||percentage of participants|||Number
62640|NCT01183481|Secondary|The Complete RINV Prophylaxis Rate (Acute and Delayed Phases), the Partial Emesis Control Rate, the Safety of the Combined Regime, QOL Issues, the Time to the First Emetic Event and Use of Rescue Medication .|Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.|From day of radiotherapy to 10 days following radiotherapy||||||
62641|NCT01183481|Primary|The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV).|Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.|Days 2-10 following radiotherapy|||participants|||Number
62642|NCT01183468|Primary|C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52|No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.|Week 52|Enrolled Sample|||||
62643|NCT01183390|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
62644|NCT01183390|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
62645|NCT01183312|Secondary|EEG Power||following drug administration||||||
62646|NCT01183312|Secondary|Change in Stanford Sleepiness Scale|The Stanford Sleepiness Scale (SSS) is a subjective rating of sleepiness, with score ranging from 1 to 7, where higher values reflect more severe sleepiness. The measure used was change in SSS from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||units on a scale||Standard Deviation|Mean
62647|NCT01183312|Secondary|PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT|At the end of the 10 minute PVT testing period, subjects were asked to rate their current level of sleepiness along a line, which was transformed into a numeric value from 1-10, such that high levels indicated more severe subjective sleepiness. The measure used was the change in this rating from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||units on a scale||Standard Deviation|Mean
62648|NCT01183312|Secondary|PVT Additional Measure #4, Change in False Response Frequency|The false response frequency is defined as the number of button presses when no stimulus is presented. The measure used was the change in false response frequency from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||number of false starts||Standard Deviation|Mean
62649|NCT01183312|Secondary|PVT Additional Measure #3, Change in Optimum Response Times|The optimum response times is defined as the reciprocal of the reaction time averaged across the fastest 10% of responses. The measure used was the change in optimum response time from baseline to following drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||1/msec||Standard Deviation|Mean
62650|NCT01183312|Secondary|PVT Additional Measure #2, Change in Duration of Lapse Domain|The PVT duration of lapse domain is defined as the reciprocal of the reaction time averaged across the slowest 10% of responses. The measure used was the change in duration of lapse domain from baseline to drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||1/msec||Standard Deviation|Mean
62651|NCT01183312|Secondary|PVT Additional Measure #1, Change in Lapse Frequency|A PVT lapse is defined as a reaction time exceeding 500 msec following the presentation of a single stimulus, which are then summed for the entire 10 minute PVT testing period. The measure used was the change in the frequency of lapses from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||number of lapses during PVT testing||Standard Deviation|Mean
62652|NCT01183312|Primary|Change in Psychomotor Vigilance Task (PVT) Median Reaction Time|The PVT measures the reaction time to button press following the presentation of a visual stimulus, reported here as the median reaction time for multiple presentations during the 10 minute task. The measure used was the change in median reaction time from baseline to drug administration, where the median reaction time at each of the time points (below) was averaged to provide a single on-treatment value for median reaction time. The measure was then calculated as baseline value - treatment value, such that higher numbers denote improvement from baseline.|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)||msec||Standard Deviation|Mean
62653|NCT01183234|Primary|Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set||hours||Full Range|Median
62654|NCT01183234|Primary|Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set||ng/ml||90% Confidence Interval|Least Squares Mean
62655|NCT01183234|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)|AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|Pharmacokinetic analysis set (PK) defined as all subjects in the safety analysis set who had evaluable plasma concentration-time profiles for MPH through 24 hours post-dosing in both treatment periods. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded.||ng*h/ml||90% Confidence Interval|Least Squares Mean
62656|NCT01183169|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.|within 24 weeks after treatment|FAS For Efficacy||percentage of participants|||Number
62657|NCT01183169|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"On-treatment viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOQ) during treatment"|within 48 weeks|FAS For Efficacy||percentage of participants|||Number
62658|NCT01183169|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End||Up to 48 weeks|Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point||percentage of participants|||Number
62659|NCT01183169|Secondary|Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD|ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.|within 48 weeks|FAS For Efficacy||percentage of participants|||Number
62660|NCT01183169|Secondary|Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD|pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy||percentage of participants|||Number
62661|NCT01183169|Secondary|Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD|RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.|after 4 weeks of treatment|FAS For Efficacy||percentage of participants|||Number
62662|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD|SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.|24 weeks after treatment|FAS For Efficacy||percentage of participants|||Number
62663|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD|SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.|12 weeks after treatment|FAS For Efficacy||percentage of participants|||Number
62664|NCT01183169|Secondary|Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)|cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy||percentage of participants|||Number
62665|NCT01183169|Primary|Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)|cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment||percentage of participants|||Number
62666|NCT01183065|Primary|To Determine the Overall Response Rate (CR+PR)|by RECIST version 1.1 criteria|2 years|||participants|||Number
62667|NCT01183013|Secondary|Incidence of Rescue Therapy During the First 30 Weeks of Treatment|Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.|30 weeks|FAS||participants|||Number
62668|NCT01183013|Secondary|Time to First Use of Rescue Therapy|Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.|30 weeks|FAS||Proportion of participants|||Number
62669|NCT01183013|Secondary|Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)|The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.|Baseline and 30 weeks|MTT set: This patient set includes those patients in the FAS who had a valid MTT at baseline and at least one valid on-treatment MTT. An MTT is considered valid if both an FPG and a 2-hour PPG value are available.||mg/dL||Standard Error|Least Squares Mean
62670|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)||mg/dL||Standard Error|Mean
62671|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment|The change from baseline is the FPG after 30 weeks minus the baseline FPG.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with a value for FPG at baseline and on-treatment. Last observation carried forward (LOCF) used to handle missing values at Week 30.||mg/dL||Standard Error|Mean
62672|NCT01183013|Secondary|HbA1c Change From Baseline by Visit Over Time|"HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.~by visit interaction."|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)||percent||Standard Error|Mean
62673|NCT01183013|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS with non-completers (without a value at Week 30) considered as failure||participants|||Number
62674|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c >=6.5%. Non-completers (patients without a value at Week 30) were considered as failures (NCF)||participants|||Number
62675|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c>=7%.Non-completers (patients without a value at Week 30) were considered as failures (NCF).||participants|||Number
62676|NCT01183013|Primary|Change From Baseline in HbA1c After 30 Weeks of Treatment.|HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c.||percent||Standard Error|Mean
62677|NCT01182805|Primary|Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler|E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.|Assessed from echo obtained at time of enrollment|Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects.||cm/sec||Standard Deviation|Mean
62678|NCT01182805|Primary|Diastolic Circumferential Strain Rate During Isovolumic Relaxation|Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.|Assessed from echo obtained at time of enrollment|Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects.||1/sec||Standard Deviation|Mean
62679|NCT01182727|Primary|Side Effects of Salsalate|This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects.|6 weeks|All subjects who completed the study were analyzed.||participants|||Number
62680|NCT01182675|Secondary|Percent Engraftment of Donor T-cells in Blood by STR Testing|We will measure whether we are able to detect donor T-cells in the patient's blood after HSCT.|1 Year||||||
62681|NCT01182675|Secondary|Percent Engraftment of Donor Stem Cells in Bone Marrow by STR Testing|We will measure whether we are able to detect donor stem cells in the patient's bone marrow after HSCT.|1 Year||||||
62682|NCT01182675|Secondary|Percentage of Patients Who Become Independent From Regular IVIG Infusion|Based on B-cell function assays from the patient's blood, we will be able to determine if patients are able to successfully discontinue IVIG infusions.|2 Years||||||
62683|NCT01182675|Secondary|Incidence of Chronic GVHD||2 Years||||||
62684|NCT01182675|Secondary|Incidence of Acute GVHD||100 Days||||||
62685|NCT01182675|Primary|Engraftment of Donor B-cells in Blood by STR Testing|Number of participants in whom donor B cells were detected in the patient's blood after HSCT.|1 Year|||participants|||Number
62686|NCT01182610|Secondary|Survival||2-year survival from first dose of panitumumab|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
62687|NCT01182610|Secondary|Thirty-day Surgical Mortality|All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.|From date of surgery to 30 days after date of surgery|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
62706|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62707|NCT01182428|Secondary|In-segment Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||% diameter stenosis|Participants|Standard Deviation|Mean
62688|NCT01182610|Secondary|Resection Rate of Surgery|"The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H&E)examination, and the operative report indicates complete resection with no residual disease.~The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H&E) examination, and the operative report indicates complete resection with no residual disease.~The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease."|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
62689|NCT01182610|Secondary|Pathologic Response Rate|The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H&E) examination.|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
62690|NCT01182610|Primary|Response Rate|The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.|From the start of study treatment until restaging evaluation performed between days 36 to 43|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.|||||
62691|NCT01182493|Secondary|Change in Body Weight or BMI, Lipids and Blood Pressure||6 months||||||
62692|NCT01182493|Secondary|Quality of Life and Treatment Satisfaction||6 months||||||
62693|NCT01182493|Secondary|Change in Postprandial Glycemia|Change in mean postprandial hyperglycemia 0 to 2 hours post meal, defined as ≥180 mg/dl and measured by SMBG|6 months||||||
62694|NCT01182493|Secondary|Safety|Severe hypoglycemia incidence; Diabetic Ketoacidosis incidence and Diabetes related hospitalizations|6 months treatment and 6 months follow-up||||||
62695|NCT01182493|Secondary|Change in Glycemic Variability|Glycemic parameters calculated from blinded CGM data: Measure of the Average glucose/day; AUC in hypo- (≤70mg/dL) and in hyperglycemia (≥180 mg/dL; Time spent in hypo- (≤70mg/dL) and hyperglycemia (≥180 mg/dL); Mean Amplitude of Glycemic Excursions (MAGE) is the most common measure of the volatility of blood glucose levels; Standard deviation|6 months||||||
62696|NCT01182493|Primary|Between Group Difference in HbA1c When Comparing CSII to MDI|To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period|6 months|||% HbA1c||Standard Deviation|Mean
62697|NCT01182480|Secondary|Glycemic Control|Measured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.|3 months||||||
62698|NCT01182480|Secondary|Perceived Self-efficacy|As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention|3 months||||||
62699|NCT01182480|Secondary|Appointment Attendance|As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups|3 months||||||
62700|NCT01182480|Primary|Patient Engagement|Patient engagement was assessed by patient text message response rates and average response times. Response rates were calculated as a percentage from the number of patient-initiated text messages sent in response to a system-generated request for information (the numerator) divided by the total number of system-generated requests for information (the denominator). Average response times were calculated from system-recorded time stamps for outbound requests sent and inbound patient-initiated responses received.|3 months|Group of study participants who received the text message intervention over a 3-month period.||text message response rate (percent)|||Number
62701|NCT01182428|Secondary|Persisting Dissection|All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
62702|NCT01182428|Secondary|Thrombus|All subjects with thrombus of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
62703|NCT01182428|Secondary|Aneurysm|All subjects with aneurysm of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||% of target lesions with aneurysm|Participants|95% Confidence Interval|Number
62704|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62705|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62709|NCT01182428|Secondary|In-segment Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||Percentage of target lesions|Participants|95% Confidence Interval|Number
62710|NCT01182428|Secondary|In-stent Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||Percentage of Target Lesions|Participants|95% Confidence Interval|Number
62711|NCT01182428|Secondary|In-segment Late Loss (LL)|LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up|at 270 days|The angiographic analysis population may be less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||millimeters|Participants|Standard Deviation|Mean
62712|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62713|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62714|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62715|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62716|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62717|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62718|NCT01182428|Primary|In-stent Late Loss (LL) (Main Secondary Endpoint)|In-stent Minimal Lumen Diameter (MLD)post-procedure – in-stent MLD at follow-up.|at 270 days|The angiographic analysis population may be than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.||millimeters|Participants|Standard Deviation|Mean
62719|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62720|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62721|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62722|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62723|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62724|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable, Possible)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
62725|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population. Population change based on follow up timeframe.||Percentage of Participants||95% Confidence Interval|Number
62726|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||1 to 30 days (Sub-Acute)|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
62727|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||< 1 day (Acute)|Based on Intent to Treat (ITT) population.||Percentage of Participants||95% Confidence Interval|Number
62730|NCT01182428|Primary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).|This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of Participants||95% Confidence Interval|Number
62731|NCT01182376|Primary|LA Fibrosis|The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.|baseline, 1 year|The number of participants analyzed for both groups is less than the number enrolled due to patient attrition or poor MRI scans.||percentage of fibrosis||Standard Deviation|Mean
62732|NCT01182337|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|"FAS Population~Only 21 subjects from the rhGDF-5 group (out of 22 subjects total) completed the MCS, SF-36."||units on a scale||Standard Deviation|Mean
62733|NCT01182337|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 months|"FAS Population~Only 21 subjects from the rhGDF-5 group (out of 22 total subjects) completed the baseline PCS, SF-36."||units on a scale||Standard Deviation|Mean
62734|NCT01182337|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
62735|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
62736|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
62737|NCT01182337|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 month|FAS Population||units on a scale||Standard Deviation|Mean
62738|NCT01182337|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~For the Neurological Assessment at 12 months, only 21 subjects from the rhGDF-5 group completed the assessment (out of 22 total subjects) and 5 subjects from the Control group completed the assessment (out of 9 subjects total)."||participants|||Number
62739|NCT01182298|Primary|Median Log Change in HCV RNA Levels on Day 7|The primary end point of this study is the the log change in HCV RNA levels on Day 7|first 7 days|||log IU/mL||Inter-Quartile Range|Median
62740|NCT01182285|Secondary|NIS (Na/I-symporter) Expression|NIS (Na/I-symporter) Expression is assessed by quantitative reverse transcription (RT) polymerase chain reaction (PCR) and immunohistochemistry (IHC). NIS mRNA expression was measured by quantitative RT PCR from biopsy samples.|Entry to study and after 10 weeks of treatment|There is no standard of error to report. The acronym GAPDH expanded is glyceraldehyde 3-phosphate dehydrogenase. Only 1 participant was analyzed because biopsies were not performed in 12 subjects.||percent expression||Standard Error|Median
62741|NCT01182285|Secondary|Best Overall Response|Best overall response was assessed by radioiodine uptake. Complete response (CR) is increased Rai (radioiodine) uptake on post- valproic acid therapy at week 10, AND a decrease in Tg (thyroglobulin ) level to less than 2 ng/ml (or a decrease in Tg-Ab (thyroglobulin antibodies) level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Week 16|Best overall response was not assessed for the phase 1 portion.||participants|||Number
62742|NCT01182285|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|41 months and 11 days|Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study.||participants|||Number
62805|NCT01181726|Primary|AUC0-inf of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
62743|NCT01182285|Primary|RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment|Complete response (CR) is increased Rai uptake on post- valproic acid therapy at week 10, AND a decrease in Tg level to less than 2 ng/ml (or a decrease in Tg-Ab level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Entry to study and after 10 weeks of treatment for Phase 1, and 10 weeks of treatment to 16 weeks of treatment for phase 2.|13 participants were enrolled in phase 1 and 8/13 (5 from University of California San Francisco (UCSF) moved on from phase 1 to the phase 2 schedule 2 portion. However, Tg data from UCSF is unavailable for 5 of the participant, thus only 3 were analyzed in the phase 2 portion.||participants|||Number
62744|NCT01182207|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62745|NCT01182207|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62746|NCT01182207|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
62747|NCT01182207|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
62748|NCT01182207|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
62749|NCT01182207|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
62750|NCT01182194|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||pg*h/mL||Standard Deviation|Mean
62751|NCT01182194|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||pg*h/mL||Standard Deviation|Mean
62752|NCT01182194|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||pg/mL||Standard Deviation|Mean
62753|NCT01182194|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||ng*h/mL||Standard Deviation|Mean
62754|NCT01182194|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||ng*h/mL||Standard Deviation|Mean
62755|NCT01182194|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.||ng/mL||Standard Deviation|Mean
62756|NCT01182181|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
62757|NCT01182181|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
62758|NCT01182103|Secondary|BDNF Levels of MDD Patients Before and After Treatment and Healthy Controls|"Serum BDNF levels were measured. MDD patients received antidepressant treatment, a standard biological management. Nothing novel (such as experimental drugs or management) is introduced in the treatment, so the research design is observational (of standard treatment).~The choice of antidepressant drugs depended on the need of patients in natural treatment procedure. They included selective serotonin reuptake inhibitors (SSRI), eg. fluoxetine or paroxetine."|2 years|||ng/ml||Standard Deviation|Mean
75630|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Protein C|Study day five.|||percentage of activity||Standard Error|Mean
62759|NCT01182103|Primary|Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls|"Chromatin immunoprecipitation (ChIP) was used to measure histone modification. The unit of our given machine is relative quantification, and a higher value indicated increased histone modification. The detailed method could be found in:~Huebert DJ, Kamal M, O’Donovan A, Bernstein BE: Genome-wide analysis of histone modifications by ChIP-on-chip. Methods 2006; 40: 365–369."|2 years|||relative quantification||Standard Deviation|Mean
62760|NCT01182103|Primary|Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls|averaged percentage of methylation at each CpG site listed|2 years|Only 39 out of the 48 MDD patients provided enough blood sample for this analysis.||percent||Standard Deviation|Mean
62761|NCT01181986|Secondary|Plasma Glucose|Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6, and 8 hours post-study drug on day 11|||mg/dl||Standard Error|Least Squares Mean
62762|NCT01181986|Secondary|Plasma Triglycerides|Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6 and 8 hours post-study drug on day 11|||mg/dl||Standard Error|Least Squares Mean
62763|NCT01181986|Primary|Reactive Hyperemia Index (RHI)|Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.|0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)|||ratio||Standard Error|Least Squares Mean
62764|NCT01181947|Primary|Technical Success at Time of Initial Implant|Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system|intraoperatively|"The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."||participants||95% Confidence Interval|Number
62765|NCT01181947|Secondary|ACM and ARM|All-cause (ACM), Aneurysm related (ARM) and dissection related mortality|at 30 days, 12 months, 24 months and 36 months||||||
62766|NCT01181947|Secondary|SAE|Serious Adverse Events (SAE)|through 12 months|"The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."||participants||95% Confidence Interval|Number
62767|NCT01181947|Primary|Treatment Success|"technical success and freedom from~TAA diameter increase of stented segment (>5mm compared to 1 mo),~Types I/III endoleak,~Aneurysm rupture,~Conversion to open surgery,~Stent graft occlusion,~Stent graft migration resulting in SAE or secondary intervention."|at 30 days, 12 months, 24 months and 36 months||||||
62768|NCT01181921|Primary|Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks|Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.|Baseline and 12 weeks|Only one participant was recruited and did not complete the study; therefore no assessments have been conducted throughout the study.|||||
62769|NCT01181895|Secondary|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12|At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.|Week 4 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.||Participants|||Number
62770|NCT01181895|Secondary|Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)|The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.|Day 1 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.||Participants|||Number
62771|NCT01181895|Secondary|Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Liters per minute (L/min)||Standard Error|Least Squares Mean
62772|NCT01181895|Secondary|Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Liters per minute (L/min)||Standard Error|Least Squares Mean
62773|NCT01181895|Secondary|Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
62774|NCT01181895|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
62775|NCT01181895|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
62776|NCT01181895|Primary|Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
62777|NCT01181804|Primary|t1/2 Boceprevir in Fasted State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||hours||Standard Deviation|Mean
62778|NCT01181804|Primary|Half Life (t1/2) of Boceprevir in Fed State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||hours||Standard Deviation|Mean
62779|NCT01181804|Primary|AUCinf in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
62780|NCT01181804|Primary|AUC From Hour 0 to Infinity (AUCinf) in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
62781|NCT01181804|Primary|Cmax of Boceprevir Tablets Versus Capsules in Fasted State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng/mL||90% Confidence Interval|Geometric Mean
62782|NCT01181804|Primary|AUCtf for Boceprevir Tablets Versus Capsules in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
62783|NCT01181804|Primary|Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
62784|NCT01181804|Primary|Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.||ng*hr/mL||90% Confidence Interval|Geometric Mean
62785|NCT01181778|Secondary|Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method|Participant contacts with physician offices were collected, and the number of callbacks by method of contraception recorded. Participants who called back more than once were counted overall and for each method of contraception.|Up to four months after the counseling visit|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.||percentage of participants|||Number
62786|NCT01181778|Primary|Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling|Before receiving counseling, participants recorded on a questionnaire the method of contraception they thought they would choose. This was to be compared with the method of contraception the same participants thought they would choose after they received physician counseling, which was also recorded on their questionnaire.|Day of inclusion (Day 0) prior to physician counseling and after physician counseling|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.||Participants|||Number
62787|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62788|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62789|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
62790|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62791|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62792|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
62793|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62794|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62795|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
62796|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62797|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62798|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
62799|NCT01181726|Secondary|AUC0-inf of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62800|NCT01181726|Secondary|AUC0-t of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62801|NCT01181726|Secondary|Cmax of Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
62802|NCT01181726|Primary|AUC0-inf of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62803|NCT01181726|Primary|AUC0-t of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
62804|NCT01181726|Primary|Cmax of Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
62806|NCT01181726|Primary|AUC0-t of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
62807|NCT01181726|Primary|Cmax of Norethindrone (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
62808|NCT01181609|Secondary|OS - Time to Event|OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.|Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)|ITT population||months||95% Confidence Interval|Median
62809|NCT01181609|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|Overall survival was defined as the time from start of study treatment to death from any cause.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population||percentage of participants|||Number
62810|NCT01181609|Secondary|Duration of Overall Disease Control|ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.|Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)|ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis.||months||95% Confidence Interval|Median
62811|NCT01181609|Secondary|Duration of Response|Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.|Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)|ITT population; only participants with a response (CR or PR) were included in the analysis.||months||95% Confidence Interval|Median
62812|NCT01181609|Secondary|PFS - Time to Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population||months||95% Confidence Interval|Median
62813|NCT01181609|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT||percentage of participants|||Number
62814|NCT01181609|Secondary|Percentage of Participants Achieving a Best Overall Response of CR or PR|Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population||percentage of participants||95% Confidence Interval|Number
62815|NCT01181609|Primary|Percentage of Participants Achieving Overall Disease Control (ODC)|ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)|ITT population||percentage of participants||95% Confidence Interval|Number
62816|NCT01181531|Secondary|Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|week 40-52|||Participants|||Number
62817|NCT01181531|Secondary|Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)|Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Baseline to week 40-52|||Participants|||Number
62818|NCT01181531|Primary|Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52|Baseline to week 40-52|All subjects randomized by treatment arm.||Percent change||Standard Error|Least Squares Mean
62819|NCT01181492|Secondary|PCA Fentanyl Consumption|PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.|24 h after surgery|||μg||Standard Deviation|Mean
62820|NCT01181492|Secondary|The Visual Analog Scale 24 Hours Postoperative|The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation|24 hours after operation|||units on a scale||Standard Deviation|Mean
62821|NCT01181492|Primary|CYP3A4*1G Polymorphism|According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G|48 hours after operation|the number of participants for analysis was determined according to gene type of CYP3A4*1G polymorphism which was carried by participant.||participants|||Number
62822|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events||From end of surgery through hospital discharge, an expected average of 6 days|FAS population includes all treated participants||participants|||Number
62914|NCT01181011|Primary|AUC_0-tz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Amlodipine||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
62823|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents|Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.|From end of surgery through PACU arrival, an expected average of 10 minutes|FAS population includes all treated participants||participants|||Number
62824|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane|Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received propofol or sevoflurane are included||participants|||Number
62825|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents|Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received atracurium, cisatracurium, rocuronium or vecuronium are included||participants|||Number
62826|NCT01181349|Primary|Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival|The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio <0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).|Upon arrival in the PACU|Full analysis set (FAS) population includes all treated participants||participants|||Number
62827|NCT01181323|Secondary|ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects|Blood was collected from maternal subjects on Day 0 prior to vaccination, and at Day 28 post vaccination for assessment of IgA and IgG antibodies with a standard ELISA assay. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons' vaccines, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and Day 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.||units/mL||95% Confidence Interval|Geometric Mean
62828|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination.|Breast milk was collected from all maternal participants prior at Days 2 and 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 and 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
62829|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 8 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 8 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.||participants|||Number
62830|NCT01181323|Secondary|Number of Maternal and Infant Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 2 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal and infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 2 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.||participants|||Number
62831|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 0 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 0 prior to vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.||participants|||Number
62832|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
62856|NCT01181128|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes, including from the loading dose to the end date/time of surgery.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||injections|Participants|Full Range|Median
62833|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
62834|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all infant participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
62835|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
62836|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
62837|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of nasal congestion, runny nose, cough, sore throat, nasal bleeding, pain at injection site, tenderness at injection site, and swelling at injection site for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
62838|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, weakness, and chills for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
62839|NCT01181323|Primary|Number of Maternal Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.||participants|||Number
62840|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
62841|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.||participants|||Number
62842|NCT01181323|Secondary|Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection for the assay was a titer of 10, sera samples below detection were given a value of 5 for analysis.|Day 0 and 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.||titer||95% Confidence Interval|Geometric Mean
62843|NCT01181323|Primary|Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination|Maternal participants were contacted by telephone at Day 42 to report all medically attended respiratory or gastrointestinal adverse events occurring in the infant participants between 28 and 42 days after maternal vaccination.|Within 28-42 days after maternal vaccination|All infant participants for whom the maternal participants were contacted are included in the analysis population description. One maternal participant was not contacted.||participants|||Number
62844|NCT01181323|Primary|Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains|Breast milk was collected at Day 0 prior to vaccination and again at 28 days following vaccination for testing in IgA and IgG ELISA Assays. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and 28 post vaccination|All enrolled maternal participants are included in this analysis population.||units/mL||95% Confidence Interval|Geometric Mean
62845|NCT01181323|Primary|Number of Participating Reporting Non-serious Unsolicited Adverse Events Related to Vaccination Within 28 Days of Maternal Vaccination|Adverse events (AE) for this protocol used the International Conference on Harmonization (ICH) guideline E6 definition of AE, any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product. Related was defined as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. Non-serious AEs were those that did not meet the definition of serious (see Outcome Measure 1). Maternal participants were queried at each visit through 28 days after vaccination for the occurrence of any AE for her or the infant separately from the pre-defined solicited symptoms.|Day 0 to Day 28 post vaccination|All enrolled participants are included in the analysis population for this outcome measure||participants|||Number
62846|NCT01181323|Primary|Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination|Maternal participants maintained a memory aid to record daily the occurrence in their infants of systemic adverse events of fever (defined as rectal temperature 37.8 degrees Celsius or greater), drowsiness, irritability/fussiness, loss of appetite, nasal congestion, difficulty breathing, runny nose, and cough for 11 days (Day 0-10) after maternal vaccination based on protocol-defined grading (none, mild, moderate or severe) for each symptom. Rectal temperature was measured once daily. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 11 days.|Day 0 to Day 10 post vaccination|||participants|||Number
62847|NCT01181323|Primary|Number of Participants Reporting New Onset Chronic Medical Conditions|New onset chronic medical condition was defined as any new ICD-10 diagnosis for a participant that was expected to continue for at least 6 months and require continued health care intervention. ICD-10 = International Statistical Classification of Diseases and Related Health Problems, 10th revision. Maternal participants were asked at each visit through 180 days after enrollment if they or their infants had any new diagnosis.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.||participants|||Number
62848|NCT01181323|Primary|Number of Participants Reporting Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.||participants|||Number
62849|NCT01181167|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding||2 weeks|Safety analyses were performed for the Safety Analysis Set, which was defined as all subjects who were secondarily enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or who had no safety data after the start of study treatment.||percentage of subjects with bleeds||95% Confidence Interval|Number
62850|NCT01181167|Primary|Incidence of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.||percentage of subjects with vte events||95% Confidence Interval|Number
62851|NCT01181141|Secondary|Proportion of Subjects With Venous Thromboembolism Events.||2 weeks||||||
62852|NCT01181141|Primary|The Incidence of Major or Clinically Relevant Non-major Bleeding|Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.|2 weeks|Safety Analysis Set defined as all subjects who were secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any study drug, or had no safety data after start of study treatment. However, subjects who had significant GCP violations, but received at least one dose of study drug, safety data were assessed.||percentage of subjects with bleeds||95% Confidence Interval|Number
62853|NCT01181128|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||surgeries|Participants||Number
62854|NCT01181128|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc, underwent major surgery, and had blood loss during surgery information available.||mL|Participants|Full Range|Median
62855|NCT01181128|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||IU/kg|Participants|Full Range|Median
62857|NCT01181128|Secondary|Investigators’/Surgeons’ Assessment of Participants’ Response to rFVIIIFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.||responses|Participants||Number
62858|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 14 and Week 28 in Haemo-QoL III Total Score|The Haemo-QoL III, a quality of life assessment instrument for adolescents with hemophilia, was administered to participants from 13 to 16 years old. This instrument assesses domains specific to living with hemophilia and consists of 12 domains: physical health, feeling, view of yourself, family, friends, others, sports and school, treatment, perceived support, dealing with hemophilia, future, and relationships. Total HAEMO-QoL score is the sum of all raw scores for all subscales for participants for whom at least the minimum number of required questions have been answered. Total scores are presented as the Transformed Scale Score (TSS) from 0-100%, with lower scores indicating a better quality of life. A negative change indicates improvement.|Baseline, Week 14, Week 28|Full Analysis Set: participants 13 to 16 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
62859|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 28|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 28|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
62860|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 14|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 14|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
62861|NCT01181128|Secondary|Incremental Recovery (Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
62862|NCT01181128|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
62863|NCT01181128|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/h/kg||95% Confidence Interval|Geometric Mean
62915|NCT01181011|Primary|The Maximum Observed Plasma Concentration (Cmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for Cmax of Telmisartan||ng/mL||Geometric Coefficient of Variation|Geometric Mean
75631|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti-thrombin III|Study day five.|||percentage of activity||Standard Error|Mean
62864|NCT01181128|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
62865|NCT01181128|Secondary|Area Under the Curve (AUC) Per Dose (Two-stage Chromogenic Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
62866|NCT01181128|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which the maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
62867|NCT01181128|Secondary|Time at Maximum Activity (Tmax; One-stage Clotting Assay)|Time at which maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
62868|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (Two-stage Chromogenic Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||days||95% Confidence Interval|Geometric Mean
62869|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (One-stage Clotting Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||days||95% Confidence Interval|Geometric Mean
62916|NCT01181011|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Telmisartan||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
62917|NCT01181011|Primary|Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Telmisartan||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
62870|NCT01181128|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/kg||95% Confidence Interval|Geometric Mean
62871|NCT01181128|Secondary|Volume at Steady State (Vss; One-stage Clotting Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/kg||95% Confidence Interval|Geometric Mean
62872|NCT01181128|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.||IU/kg||Inter-Quartile Range|Median
62873|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had evaluable efficacy assessments; n=total number of bleeds at given location.||injections||Inter-Quartile Range|Median
62874|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 bleeding episode.||injections|Participants|Inter-Quartile Range|Median
62875|NCT01181128|Secondary|Number of Days From Last Treatment Injection to a New Bleeding Episode|Number of days from the last injection to treat a bleeding episode to a new bleeding episode, analyzed for per evaluable bleeding episode and per participant. For “per participant” values, number of days from last injection to treat a bleed to a new bleeding episode is averaged across all evaluable bleeding episodes for each participant first, and then descriptive statistics were calculated across participants. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (not evaluable). The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode. The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time.||days|Participants|Inter-Quartile Range|Median
62918|NCT01180998|Primary|Distance Visual Acuity (VA)|Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 4 weeks of toric contact lens wear|Analysis was conducted on those subjects who were enrolled randomized to a treatment arm and completed the study.||logMAR|Participants|Standard Error|Least Squares Mean
62876|NCT01181128|Secondary|Annualized Joint Bleeding Rate (Spontaneous and Traumatic)|Annualized bleeding episodes = (Number of bleeding episodes of the specified type / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.||bleeding episodes per participant per yr||Inter-Quartile Range|Median
62877|NCT01181128|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (Number of bleeding episodes at the specified location / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.||episodes per participant per year||Inter-Quartile Range|Median
62878|NCT01181128|Secondary|Investigator’s Assessment of Participants’ Bleeding Response to rFVIIIFc Injection|The investigator was given the opportunity to record an assessment of a participant’s response to treatment, if the participant was treated in the hospital for a major bleed, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|This supplemental assessment was not summarized because of insufficient data.|||||
62879|NCT01181128|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode; based on the number of injections with an evaluation.||percentage of responses|Participants||Number
62880|NCT01181128|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. Overall units (IU/kg) of annualized rFVIIIFc consumption = [Total rFVIIIFc IU/kg received during the efficacy period / number of days in efficacy period] x 365.25.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and >=6 months on study.||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
62881|NCT01181128|Secondary|Comparison of Annualized Bleeding Rates: Arm 2 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.||episodes per participant per year||95% Confidence Interval|Number
62888|NCT01181128|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes during the efficacy period / number of days during the efficacy period)*365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.||episodes per participant per year||Inter-Quartile Range|Median
62882|NCT01181128|Primary|Incremental Recovery (One-stage Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
62883|NCT01181128|Primary|Mean Residence Time (MRT; One-stage Clotting Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
62884|NCT01181128|Primary|Clearance (CL; One-stage Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||mL/h/kg||95% Confidence Interval|Geometric Mean
62885|NCT01181128|Primary|Elimination Half Life (t1/2; One-stage Clotting Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||hours||95% Confidence Interval|Geometric Mean
62886|NCT01181128|Primary|Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
62887|NCT01181128|Primary|Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 1 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.||episodes per participant per year||95% Confidence Interval|Number
62902|NCT01181011|Secondary|t_½ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Amlodipine||h||Standard Deviation|Mean
62903|NCT01181011|Secondary|MRT_po of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Amlodipine||h||Standard Deviation|Mean
62904|NCT01181011|Secondary|λz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Amlodipine||1/h||Standard Deviation|Mean
75632|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Fibrinogen|Study day five.|||mg/dL||Standard Error|Mean
62889|NCT01181128|Primary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFVIIIFc dose. ↑ signifies increase and ↓ signifies decrease.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc and had a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, systolic blood pressure, and diastolic blood pressure.||participants|||Number
62890|NCT01181128|Primary|Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. ULN=upper limit of normal.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc n=the number of participants with at least one post-baseline value.||participants|||Number
62891|NCT01181128|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of Advate or rFVIIIFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before the last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or any other medically important event. AEs emergent between the first Advate injection and first on-study rFVIIIFc injection (Sequential PK Subgroup) or during the surgical/rehabilitation period (Surgery Subgroup) are presented separately.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc. For Arm 1, AEs emergent between 1st on-study Advate dose and 1st rFVIIIFc dose are reported as treatment-emergent to Advate (1st column); AEs emergent after 1st rFVIIIFc injection are reported as treatment-emergent to rFVIIIFc (2nd column).||participants|||Number
62892|NCT01181128|Primary|Incidence Rate of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% confidence interval (CI) were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFVIIIFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFVIIIFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
62893|NCT01181102|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment||percentage of subjects with bleeds||95% Confidence Interval|Number
62894|NCT01181102|Primary|Incidence of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment~Definite diagnosis of symptomatic Pulmonary Embolism (PE)~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE)"|2 weeks|Efficacy Analysis population. 22 (7.4%) - DU-176b 41 (13.9%) - enoxaparin||percent of participants with VTE events||95% Confidence Interval|Number
62895|NCT01181050|Secondary|Change in DAS28-CRP After 24 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.|Week 0, Week 24|Change in DAS28-CRP was calculated by using last observation carried forward method.||scores||Standard Deviation|Mean
62896|NCT01181050|Secondary|Change in DAS28-CRP After 6 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.|Week 0, Week 6|Change in DAS28-CRP was calculated by using last observation carried forward method.||scores||Standard Deviation|Mean
62897|NCT01181050|Primary|Change in DAS28-CRP After 12 Weeks of Treatment|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.|Week 0, Week 12|Change in DAS28-CRP was calculated by using last observation carried forward method.||scores||Standard Deviation|Mean
62898|NCT01181011|Secondary|Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities||4 weeks|Treated set||Participants|||Number
62899|NCT01181011|Secondary|Number of Participants With at Least One Treatment Emergent Adverse Event||4 weeks|Treated set||Participants|||Number
62900|NCT01181011|Secondary|V_z/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Amlodipine||L||Standard Deviation|Mean
62901|NCT01181011|Secondary|CL/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Amlodipine||L/h||Standard Deviation|Mean
62919|NCT01180998|Primary|Distance Visual Acuity|Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 1 week of toric contact lens wear|Analysis was conducted on those subjects who were enrolled randomized to a treatment arm and completed the study.||logMAR|Participants|Standard Error|Least Squares Mean
62920|NCT01180998|Primary|Overall Success in Fitting With a Toric Contact Lens|Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.|4 weeks|Analysis was conducted on those subjects who were enrolled, randomized to a treatment arm and completed the study.||percentage of participants||95% Confidence Interval|Number
62921|NCT01180985|Secondary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||CLUE score||Standard Deviation|Mean
62922|NCT01180985|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|Participants||Number
62923|NCT01180985|Primary|Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||CLUE score||Standard Error|Least Squares Mean
62924|NCT01180985|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|Participants||Number
62925|NCT01180985|Primary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/-1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||CLUE score||Standard Error|Least Squares Mean
62926|NCT01180985|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||participants|||Number
62927|NCT01180985|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|Participants||Number
62928|NCT01180894|Secondary|The Number of Participants Who Died||28 Days|||participants|||Number
62929|NCT01180894|Secondary|Infection|"The number of participants with at least one infection.~Specific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI)."|28 Days|||participants|||Number
62930|NCT01180894|Secondary|Iron-deficient Erythropoeisis (IDE)|An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.|14 Days|||micro mol: mol heme||Full Range|Mean
62931|NCT01180894|Primary|RBC Transfusion|The number of participants who underwent RBC transfusion.|42 Days|||participants|||Number
62932|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|Change from baseline in log10 HCV RNA level by visit.|Week 12|Efficacy analysis was performed on the virology population , which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result||log10 HCV RNA level||Standard Deviation|Mean
62933|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|The mean change from baseline in log10 HCV RNA level by visit for the virology population|Week 4|Efficacy analysis was performed on the virology population, which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result||log10 HCV RNA Level||Standard Deviation|Mean
62934|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response ( Six Months Post Dosing) (SVR24)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, six months post dosing.|6 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR24.||percentage of participants|||Number
62935|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response 12 Weeks ( Three Months Post Dosing) (SVR12)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, at 12 weeks (three months) post dosing.|3 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR12.||percentage of participants|||Number
75633|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti Xa|Study day five.|||IU/mL||Standard Error|Mean
62936|NCT01180790|Secondary|Segment 1 and Segment 2: End of Treatment Response|The percentage of the Virology Population subjects that were reported as undetectable HCV RNA at the completion of treatment.|Week 48 (Segment 1); Week 24 (Segment 2)|Segment 2 analyzed the Per Protocol Population, which includes all randomized subjects who completed 12 weeks of ACH-014625 dosing and an additional 12 weeks of Peg/Ribavirin dosing.||percentage of participants|||Number
62937|NCT01180790|Secondary|Segment 2: RVR4 (Rapid Viral Response at 4 Weeks)|For Segment 2, the percentage of subjects in the virology population that achieved RVR4, defined as HCV RNA< or equal to LOQ at the Week 4 visit.|4 weeks|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 4 weeks of ACH-0141625 dosing.||percentage of participants|||Number
62938|NCT01180790|Secondary|Segment 1: Complete Early Virologic Response (cEVR)|For Segment 1, the percentage of subjects in the virology population that achieved cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|12 weeks|Analysis for Segment 1 was performed on the virology population (which is the same as the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.||percentage of participants|||Number
62939|NCT01180790|Primary|Segment 2: Complete Early Virologic Response (cEVR)|The primary efficacy endpoint for Segment 2 of the study was the percentage of subjects achieving cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|Week 12|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 12 weeks of ACH-0141625 dosing.||percentage of participants|||Number
62940|NCT01180790|Primary|Segment 2: Safety|Segment 2: Percentage of Subjects with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|12 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625. Subjects were analyzed according to the randomized treatment.||percentage of participants|||Number
62941|NCT01180790|Primary|Segment 1 : Rapid Viral Response at Week 4 (RVR4)|The primary efficacy endpoint for Segment 1 of the study was the percentage of subjects in each treatment group achieving RVR at Week 4 (HCV RNA< or equal to LOQ at the Week 4 visit).|4 weeks|Efficacy analysis was performed on the virology population (a subset of the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.||percentage of participants|||Number
62942|NCT01180790|Primary|Segment 1: Safety|Segment 1: Percentage of subjects with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|4 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625 or Placebo. Subjects were analyzed according to the randomized treatment.||percentage of participants|||Number
62943|NCT01180777|Secondary|Corneal Staining|Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.|After 6-9 days of lens wear|All subjects who successfully completed the study.||eyes|Participants||Number
62944|NCT01180777|Secondary|Binocular Snellen Visual Acuity (VA)|Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.|10-15 minutes post lens fit|All subjects who successfully completed the study.||participants|||Number
62945|NCT01180777|Primary|Lens Fit Acceptance|Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.|10-15 minutes post lens fit|All subjects who successfully completed the study.||eyes|Participants||Number
62946|NCT01180660|Secondary|24 Hour Total Opioid Consumption|24 hour total opioid consumption using IV morphine equivalents|24 hours post surgery|||miligrams||Inter-Quartile Range|Median
62947|NCT01180660|Primary|Quality of Recovery 40 on the Day After Surgery|"Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.~The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery."|24 hours|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
62948|NCT01180647|Secondary|Adverse Events and Serious Adverse Events|AEs and SAEs per standard definitions will be measured by self-report.|Eight weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||participants|||Number
62949|NCT01180647|Secondary|Accidental Drug Overdose|Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||participants|||Number
62950|NCT01180647|Secondary|Injection Drug Use Post-release|This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.|Four weeks post-release|||percentage of participants by arm|||Number
62951|NCT01180647|Secondary|Any Opioid Use Post-release|Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||percentage of participants|||Number
62952|NCT01180647|Secondary|Participation in Community Drug Treatment Post-release|This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.||percentage of participants|||Number
63084|NCT01178671|Secondary|Alternative Measure of PTSD Severity|as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe)|up to 24 weeks|completers||units on a scale||Standard Deviation|Mean
63085|NCT01178671|Primary|Time to Discontinuation of Study Treatment||up to 24 weeks|||days||Standard Deviation|Mean
62953|NCT01180647|Primary|Post-Release Opioid Relapse|Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.|Four weeks post-release|One XR-NTX participant randomized was excluded from final data analysis due to the fact he was never released from jail to community, so primary outcome (post-release opioid relapse) could not be measured.||participants||95% Confidence Interval|Number
62954|NCT01180400|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62955|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62956|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62957|NCT01180400|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62958|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62959|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62960|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
63044|NCT01179334|Secondary|Maximum Change From Baseline in Standing Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min||Standard Deviation|Mean
62961|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62962|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62963|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62964|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62965|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62966|NCT01180400|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
62967|NCT01180400|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62968|NCT01180400|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62969|NCT01180400|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
63054|NCT01179191|Other Pre-specified|Number of Participants With Aberrant Behaviors|Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = ‘never’ and 4 = ‘very often’]. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.|Day 5|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.||Participants|||Number
62970|NCT01180400|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
62971|NCT01180400|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
62972|NCT01180400|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
62973|NCT01180400|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
62974|NCT01180400|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
62975|NCT01180296|Secondary|Serum Progesterone Levels||At approximately 28 weeks' gestation||||||
62976|NCT01180296|Primary|Rate of Recurrent Preterm Birth|Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.|Prior to 37 weeks' gestation|||participants|||Number
62977|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a sleep visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater difficulty with sleep. The change in Fibromyalgia Impact Questionnaire sleep visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents sleep improvement (i.e. a better outcome), while a positive value represents sleep worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionnaire||units on a scale||Standard Deviation|Mean
62978|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a pain visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater pain. The change in Fibromyalgia Impact Questionnaire pain visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents pain improvement (i.e. a better outcome), while a positive value represents pain worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare||units on a scale||Standard Deviation|Mean
62979|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Overall Score|The Fibromyalgia Impact Questionnaire yields a score ranging from 0 to 100, with higher scores representing a greater impact or level of symptoms. The change in Fibromyalgia Impact Questionnaire is determined by subtracting scores at baseline from scores at end of treatment. Thus negative numbers represent symptom improvement (i.e. a better outcome) and positive numbers represent symptom worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare||units on a scale||Standard Deviation|Mean
63086|NCT01178671|Primary|PTSD Severity|PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).|up to 24 weeks|intention to treat sample||units on a scale||Standard Deviation|Mean
62980|NCT01180244|Secondary|Change in Number of Positive Tender Points|"The number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations. A tender point is considered positive if less than 4 kilograms per centimeter squared pressure is required to elicit a painful response. The change in number of positive tender points is determined by subtracting the number of positive tender points at baseline from the number of positive tender points at end of treatment. Thus, a negative number represents pain improvement (i.e. better outcome), whereas a positive number represents a worsening of pain (i.e. worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|||Number of positive tender points||Standard Deviation|Mean
62981|NCT01180244|Primary|Change in Tender Point Pain Threshold|"Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of less pain sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|||units on a scale||Standard Deviation|Mean
62982|NCT01180127|Secondary|VO2max|measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the exercise, food additive lacking flavanol group had unusable data for this outcome and thus are not included in these analyses.||mL/(kg·min)||Standard Deviation|Mean
62983|NCT01180127|Secondary|Modified Rey Auditory Verbal Learning Test|Participants are read a list of words over three learning trials and the subject is asked to free recall as many words as possible after each trial. These 3 trials are followed by 1 learning trial of a distracter list and then a short delayed free recall trial of the initial list. After approximately 60-minutes, subjects are asked to freely recall words from the initial list, then to recall words form the distracter list, and then complete a forced-choice recognition trial. A source memory trial is administered in which subjects are read each presented word and then asked to identify whether they were initially presented during the 3 learning trials or during the distracter trial. Measured as a retention score (ratio) for which the number of words recalled after the short delay is divided by the number of words recalled on the third learning trial.|Up to 12 weeks after exercise/dietary intervention exposure|There were 4 subjects (1 in exercise, dietary intervention; 2 in no exercise, dietary intervention, and 1 in exercise, food additive lacking flavanol) who did not have useable data and are thus not included in analyses.||ratio||Standard Deviation|Mean
62984|NCT01180127|Primary|ModBent (Modified Benton Visual Retention Test)|This is an object recognition task. Participants view a complex stimulus, then are asked to select which one of two objects was identical to the studied stimulus. After a series of these matching trials, during the subsequent recognition trials participants are shown serially individual complex objects and asked to indicate whether the object was identical to any of the target stimuli viewed during the matching trials. Their reaction time for correct responses, measured in milliseconds, is the unit of measurement.|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the no exercise, dietary intervention group had outlying (larger than 3 standard deviation from mean) ModBent values that were deleted and hence those groups have 7 and 10 subjects analyzed rather than 8 and 11 respectively.||milliseconds||Standard Deviation|Mean
62985|NCT01180127|Primary|CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)|In steady state conditions, CBV is an indirect measure of basal metabolism in the brain. CBV-fMRI is a technique that generates maps of basal metabolism across different brain regions|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, food additive lacking flavanol arm, and one subject in the wait list control food additive without flavanol arm had non useable data for this outcome which is why there are only 8 subjects analyzed in those two arms rather than 9.||percent CBV in a brain region||Standard Deviation|Mean
62986|NCT01179919|Secondary|Steady-State Cmax and Cmin of Oseltamivir Carboxylate|Cmax is the maximum concentration and Cmin in the minimum concentration of oseltamivir carboxylate measured in nanogram of oseltamivir carboxylate per milliliter of plasma (ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir||ng/mL||Standard Deviation|Mean
62987|NCT01179919|Primary|Steady-State AUC of Oseltamivir Carboxylate|AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour*ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir||hour*ng/mL||Standard Deviation|Mean
62988|NCT01179737|Secondary|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated.|168 days||||||
62989|NCT01179737|Primary|Change in Pulmonary Vascular Resistance (PVR)|Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.|168 days||||||
62990|NCT01179737|Secondary|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. Study was prematurely terminated and efficacy data were not analyzed or summarized|Baseline, 168 days||||||
63066|NCT01179113|Primary|Post-operative Pain Using Verbal Rating Scale (VRS)|"Verbal Rating Scale goes from 0 to 10, where:~0 indicates= No pain and 10 indicates= The worst possible pain~The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay"|1 day|||Scores on a scale||Standard Deviation|Mean
62991|NCT01179672|Secondary|Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score|SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment. A negative change indicated an improvement in the participant's condition. LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing SDS Total Score at baseline and 12 weeks.||units on a scale||Standard Error|Least Squares Mean
62992|NCT01179672|Secondary|Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score|BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes). A negative change indicates an improvement in the participant's condition. LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing BPI-Interference score at baseline and 12 weeks.||units on a scale||Standard Error|Least Squares Mean
62993|NCT01179672|Secondary|Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score|BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline BPI-Severity average pain scores.||percentage of participants|||Number
62994|NCT01179672|Secondary|Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain|24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain). Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in average daily pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline 24-hour average pain score.||percentage of participants|||Number
62995|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ|SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain. The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain). A negative change indicates an improvement. LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12 weeks SF-MPQ score based on the randomized group were analyzed; last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
62996|NCT01179672|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint|PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|12 weeks|All participants with a baseline and 12-week PGI-I score.||units on a scale||Standard Error|Least Squares Mean
62997|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale|CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week CGI-S score based on the randomized group were analyzed. Data from 9 sites was not included in analysis due to wrong questionnaire used.||units on a scale||Standard Error|Least Squares Mean
62998|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale|BPI-Severity Scale was a self-reported scale that measured the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week, 24-hour BPI-Severity score based on the randomized group were analyzed.||units on a scale||Standard Error|Least Squares Mean
62999|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain|24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week 24-hour night pain score and worst pain score based on the randomized group were analyzed.||units on a scale||Standard Error|Least Squares Mean
63129|NCT01178281|Secondary|Overall Survival|The time from randomization to the death or to the latest date when participants are known to be alive.|Up to 2.5 years||08/2018||||
63000|NCT01179672|Primary|Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score|24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|Intent-to-treat (ITT) principle was applied: All participants with a baseline and 12-week 24-hour average pain score based on the randomized group were analyzed.||units on a scale||Standard Error|Least Squares Mean
63001|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk20||Standard Deviation|Mean
63002|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk12||Standard Deviation|Mean
63003|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk20||Standard Deviation|Mean
63004|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.||score change from baseline to wk12||Standard Deviation|Mean
63005|NCT01179568|Primary|Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale|Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.|Weeks 12 and 20|Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting .||percentage of responders|||Number
63006|NCT01179516|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
63007|NCT01179516|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
63067|NCT01178853|Primary|Percent Mean Change From Baseline of International Normalized Ratio (INR)|INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)|22 Days|||percent change||Standard Deviation|Mean
63008|NCT01179516|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥ 20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
63009|NCT01179516|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
63010|NCT01179516|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
63011|NCT01179516|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
63012|NCT01179490|Secondary|Pharmacokinetic Parameters (t1/2)|Plasma pharmacokinetics (t1/2) of unchanged bendamustine|On Day 1 only|||h||Standard Deviation|Mean
63013|NCT01179490|Secondary|Pharmacokinetic Parameters (AUC)|Plasma pharmacokinetics (AUC) of unchanged bendamustine|On Day 1 only|||ng・h/mL||Standard Deviation|Mean
63014|NCT01179490|Secondary|Pharmacokinetic Parameters (Tmax)|Plasma pharmacokinetics (tmax) of unchanged bendamustine|On Day 1 only|||h||Standard Deviation|Mean
63015|NCT01179490|Secondary|Pharmacokinetic Parameters (Cmax)|Plasma pharmacokinetics (Cmax) of unchanged bendamustine|On Day 1 only|||ng/mL||Standard Deviation|Mean
63016|NCT01179490|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.|Up to 2 years|||Events|||Number
63017|NCT01179490|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.~grade 1 : mild~grade 2 : moderate~grade 3 : severe or medically significant but not immediately life-threatening~grade 4 : life threatening or disabling~grade 5 : death related to AE"|Up to 2 years|||Participants|||Number
63018|NCT01179490|Secondary|Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years|||Events|||Number
63019|NCT01179490|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years|||Participants|||Number
63020|NCT01179490|Secondary|Overall Survival (OS)|OS is the period from the date of patient registration to the date of death.|Up to 2 years|||Days||Full Range|Median
63021|NCT01179490|Secondary|Duration of Response (DOR)|DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.|Up to 2 years|||Days||Full Range|Median
63022|NCT01179490|Secondary|Time to Treatment Failure (TTF)|TTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment.|Up to 2 years|||Days||Full Range|Median
63023|NCT01179490|Secondary|Progression-Free Survival (PFS)|"PFS is the period from patient registration to either the date of recurrence, exacerbation, progression or death.~Recurrence, exacerbation, progression were assessed from serum M-protein, urine M-protein, serum free light chain (FLC), the percentage of marrow plasma cells, disappearance of clonal plasma cells, plasma cell tumor in soft tissue, and bone lesion."|Up to 2 years|||Days||Full Range|Median
63024|NCT01179490|Secondary|Response Rate (Based on the Modified SWOG Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (SWOG) requires the followings:~Decline in myeloma protein of ≥25%–<74% in serum myeloma protein~Reduction in 24h urinary myeloma protein of ≥25%–<89%~No increase in skeletal destruction~Serum calcium within normal range"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
75764|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||6 months||||||
63025|NCT01179490|Secondary|Response Rate (Based on the Bladé Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (Bladé) requires 1. or all of the others:~Some, but not all, of the criteria for CR are fulfilled~≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks.~Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks.~For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks.~≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination).~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)."|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
63026|NCT01179490|Secondary|CR Rate Based on the (Bladé) Criteria|"The proportion of subjects evaluated as CR was calculated.~CR (Bladé) requires all of the followings:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR.~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)~Disappearance of soft tissue plasmacytomas"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
63027|NCT01179490|Secondary|Response Rate (Based on the IMWG Criteria)|"The proportion of subjects evaluated as response [sCR + CR + very good partial response (VGPR) + Partial Response (PR)] was calculated.~VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 h~PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to <200mg per 24 h"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
63028|NCT01179490|Secondary|CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]|"The proportion of subjects evaluated as CR [strict CR (sCR) + CR] was calculated.~sCR (IMWG): CR as defined below plus Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~CR (IMWG): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow"|Up to 36 weeks|||Percentage of participants||95% Confidence Interval|Number
63029|NCT01179490|Primary|Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]|"The proportion of subjects evaluated as CR was calculated.~CR (modified SWOG) requires all of the followings:~Decline in serum myeloma protein by ≥75% to ≤25 g/L~Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h~No increase in skeletal destruction~Serum calcium within normal range~No blood transfusion required in the previous 3 months"|Up to 36 weeks|||Percentage of Participants||95% Confidence Interval|Number
63030|NCT01179399|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960|Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)|up to 12 months|Maximum tolerable dose (MTD) and recommended phase 2 dose (RP2D) of TAK-960 were not determined due to sponsor decision to discontinue the study for business reasons.|||||
63031|NCT01179347|Secondary|Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score|Different format of CFQ-R are used depending of the patients' age. Adolescent and adult format of CFQ-R is used for patients of 14 years and older, for younger children a parent version and a children format is used. In case parent and children questionnaires were filled out, the children questionnaire is taken into account. Scores were calculated for each domain of the CFQ-R which are presented separately. A score of 100 corresponds to the highest quality of life possible, whereas a score of 0 corresponds to the lowest quality of life possible. Increasing score indicates better health.|Baseline and 12 weeks|FAS reduced to patients having CFQ-R information at baseline and at week 12.||Units on a scale||Standard Deviation|Mean
63032|NCT01179347|Secondary|Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment|Selected questions from the Respiratory and Systemic Symptoms Questionnaire (RSSQ), the investigator assessment of physical findings and pulmonary function, and the use of intravenous antibiotics as a concomitant therapy were used to determine if a cystic fibrosis-related pulmonary exacerbation had occurred.|12 weeks|FAS reduced to patients having RSSQ information on day 29, 57 or 85.||Percentage of Participants|||Number
63033|NCT01179347|Secondary|Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25−75) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. FEF25−75 is also known as maximum mid-expiratory flow and was measured before bronchodilator (salbutamol) use. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
63034|NCT01179347|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FCV was defined as the pre-dose FVC measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
63083|NCT01178671|Secondary|PTSD Self-rated Severity|as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe).|up to 24 weeks|completers||units on a scale||Standard Deviation|Mean
76594|NCT01036438|Primary|Efficacy Will be Defined as Absolute Wound Size Reduction.|Efficacy will be defined as absolute wound size reduction.|8 weeks|||cm2||Standard Deviation|Mean
63035|NCT01179347|Secondary|Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FVC AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
63036|NCT01179347|Primary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
63037|NCT01179347|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response|Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.||Percent of predicted||Standard Error|Mean
63038|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing HR describes an average within-subject increase in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min*h||Standard Deviation|Mean
63039|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine HR describes an average within-subject change in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min*h||Standard Deviation|Mean
63040|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
63041|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
63042|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
63043|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under the effect curve (AUEC) at each visit of supine SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg*h||Standard Deviation|Mean
80385|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|48 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
63045|NCT01179334|Secondary|Maximum Change From Baseline in Supine Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||Beats/min||Standard Deviation|Mean
63046|NCT01179334|Secondary|Maximum Change From Baseline in Standing Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg||Standard Deviation|Mean
63047|NCT01179334|Secondary|Maximum Change From Baseline in Supine Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg||Standard Deviation|Mean
63048|NCT01179334|Secondary|Maximum Change From Baseline in Standing Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set||mmHg||Standard Deviation|Mean
63049|NCT01179334|Primary|Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|pharmacodynamic(s) (PD) analysis set||mmHg||Standard Deviation|Mean
63050|NCT01179191|Other Pre-specified|Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
63051|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Illicit Substances|Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
63052|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
63053|NCT01179191|Other Pre-specified|Number of Participants With Abnormal Urine Drug Test Results|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
63055|NCT01179191|Secondary|Investigator's Level of Satisfaction With the EMBEDA Conversion Guide|The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator’s level of satisfaction with the EMBEDA Conversion Guide.|Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a Scale||Standard Deviation|Mean
63056|NCT01179191|Secondary|Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)|BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), ‘0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference’.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for the respective subscale.||Units on a scale||Standard Deviation|Mean
63057|NCT01179191|Secondary|Percentage of Participants With Rescue Medications Usage During Titration|Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
63058|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.||titration steps||Standard Deviation|Mean
63059|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||titration steps||Standard Deviation|Mean
63060|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.||Days||Standard Deviation|Mean
63061|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Days||Standard Deviation|Mean
63062|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Participants were stratified based on prior opioid therapy. The 'n' is signifying those participants who were evaluated for this measure for each of the prior medication received.||Percentage of participants||95% Confidence Interval|Number
63063|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.||Percentage of participants||95% Confidence Interval|Number
63064|NCT01179113|Secondary|Postoperative Nausea and Vomiting|Number of participants that experienced Postoperative nausea and vomiting using at PACU|1 day|||participants|||Number
63065|NCT01179113|Secondary|Opioid Consumption in PACU Obtained From the Recorded Data|Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).|1 day|||mg||Standard Deviation|Mean
63130|NCT01178281|Secondary|Frequency of Adverse Events|An Adverse Event (AE) is any noxious, unintended or untoward medical occurrence that may appear or worsen in a participant during the course of a study.|Up to 2.5 years||08/2018||||
63068|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10|Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
63069|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10|Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
63070|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10|Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
63071|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10|Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.||Scores on a Scale||Standard Deviation|Mean
63072|NCT01178827|Secondary|Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 2 Post-Dose|All patients who received of Oxybutynin IR||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
63073|NCT01178827|Secondary|Plasma Levels of Sanctura XR® at Day 10 Post-dose|Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 10 Post-Dose|All patients who received of Sanctura XR®||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
63074|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.|Day 2 Post-Dose|All patients who received Oxybutynin IR||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
63075|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose|Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.|Day 10 Post-Dose|All patients who received Sanctura XR®||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
63076|NCT01178762|Primary|Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments|We performed direct fluorescent antibody (DFA) tests for Chlamydia by swabbing across the lower and upper tarsal conjunctiva four times after topical application of 0.5% proparacaine. All of the DFA tests were examined by the same experienced microbiologist who was masked to the identities and clinical conditions of the patients. Each DFA slide was read under a fluorescent microscope and was observed for discrete fluorescent chlamydial elementary bodies (EBs).The DFA test was considered positive if above 10 EBs were counted per high-power field.|4 weeks, 8 weeks and 12 weeks after the first dose of the medication|Only participants with confirmed DFA tests are counted in the results below. Participants with confirmed negative DFA tests subsequently stopped treatment and were not retested. Participants lost to follow-up are counted as not having a confirmed DFA negative test||participants|||Number
63077|NCT01178671|Secondary|Sexual Functioning|as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired).|up to 24 weeks|intent to treat||units on a scale||Standard Deviation|Mean
63078|NCT01178671|Secondary|Sleep Quality|as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired).|up to 24 weeks|intent to treat||units on a scale||Standard Deviation|Mean
63079|NCT01178671|Secondary|Adverse Effects|as assessed by Side Effect Checklist|up to 24 weeks|intent to treat||percentage of subject dropped due to AEs|||Number
63080|NCT01178671|Secondary|Remission Status|Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score <20 at endpoint|up to 24 weeks|intent to treat||percentage of subjects|||Number
63081|NCT01178671|Secondary|Response Status|Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint|up to 24 weeks|intent to treat||percentage of subjects|||Number
63082|NCT01178671|Secondary|Depression Severity|as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression).|up to 24 weeks|intent to treat||units on a scale||Standard Deviation|Mean
63087|NCT01178528|Secondary|New York Heart Association (NYHA) Class|"The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient’s limitations in physical activities caused by cardiac symptoms.~Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD.~Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD.~Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD.~Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD.~Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation."|3 months|||participants|||Number
63088|NCT01178528|Primary|Maximal Oxygen Consumption|Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.|3 months|||mL/Kg/min||Standard Deviation|Mean
63089|NCT01178528|Secondary|Quality of Life|Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome.|3 months|||units on a scale||Standard Deviation|Mean
63090|NCT01178528|Primary|Exercise Tolerance Assessed by 6 Minute Walking Test|"Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist.~Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible."|3 months|||meters||Standard Deviation|Mean
63091|NCT01178385|Secondary|Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).|This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
63092|NCT01178385|Secondary|Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)|This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
63093|NCT01178385|Primary|Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)|This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.|After an average of 16 weeks (Post-treatment)|||units on a scale||Standard Deviation|Mean
63094|NCT01178333|Secondary|Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn||From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
63095|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge||From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
63096|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.|||days||95% Confidence Interval|Median
63097|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.|||days||Standard Error|Mean
63098|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used in Hospital|Types of treatment (direct thrombin inhibitor, fondaparinux, warfarin, no treatment) provided to subjects in hospital|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
63099|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint|Heparin PF-4 OD test results were the dichotomous outcome (<1.0 vs. >=1.0). Primary endpoint was the composite endpoint of death, limb amputation/gangrene, or new thrombosis.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
63100|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia|Heparin PF-4 optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Nadir Platelet Count (x10^9 / L) was used for the degree of thrombocytopenia. The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||X10^9 / L||Standard Deviation|Mean
86863|NCT00939211|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h|||mmHg||Standard Deviation|Mean
63101|NCT01178333|Secondary|Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis|Heparin PF-4 (platelet factor 4) optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Clinical diagnosis was three groups (HIT-T, Isolated HIT and No HIT). The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|There was one missing data for optical density test results in Isolated HIT group. Therefore, 283 subjects were used for Isolated HIT group.||participants|||Number
63102|NCT01178333|Secondary|Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). LMWHs are derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn|||participants|||Number
63103|NCT01178333|Secondary|Type of Heparin Exposure - Unfractionated Heparin (UFH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). UFH has been used for the prevention and treatment of thrombosis for several decades.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn|||participants|||Number
63104|NCT01178333|Secondary|Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT|"Proportion of subjects who, at the time the positive heparin PF-4 antibody test was drawn, were in each of the following categories:~Group 1: Those with thrombosis and or without thrombocytopenia (HIT-T): 16% of 442 subjects.~Group 2: Those with thrombocytopenia but not thrombosis (Isolated HIT): 64% of 442 subjects.~Group 3: Those with neither thrombocytopenia nor thrombosis (Neither HIT-T nor Isolated HIT): 20% of 442 subjects."|From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn|||participants|||Number
63105|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The median survival time is reported by each group for the time to occurrence of major bleeding.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||95% Confidence Interval|Median
63106|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
63107|NCT01178333|Secondary|Time to Occurrence of Radiographically Confirmed Thromboembolism|"The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. However, the median survival times could not be defined for all three groups, so the mean time was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
63108|NCT01178333|Secondary|Time to Occurrence of Limb Amputation or Limb Gangrene|"Due to the small number of events, the median or mean survival time could not be defined. Therefore, the number of subjects with limb amputation or limb gangrene was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||participants|||Number
63109|NCT01178333|Secondary|Time to Death|The median survival time is reported by each group for the time to death.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||95% Confidence Interval|Median
63110|NCT01178333|Secondary|Time to Death|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|||days||Standard Error|Mean
63111|NCT01178294|Secondary|Number of Participants Who Developed an Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|21 subjects in the ITT population (n=29) with available baseline and follow-up test results||participants|||Number
63112|NCT01178294|Secondary|Number of Participants Who Developed de Novo Anti-OBI-1 Antibody Titers||Through 90 days ± 7 days following final OBI-1 dose|28 eligible subjects with acquired hemophilia A in the ITT population (n=29), of whom 18 had no detectable anti-porcine FVIII inhibitor titers at baseline (<0.6 BU) and 10 had detectable anti-porcine FVIII antibody titers at baseline (>=0.6 BU)||participants|||Number
63113|NCT01178294|Other Pre-specified|Anti-human Factor VIII Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|Anti-human factor VIII antibody titer data were presented in subject data listings. No statistical test was planned for anti-human factor VIII antibody titer.|||||
63114|NCT01178294|Secondary|PK Analysis- Terminal Half-life|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. Half-life was calculated as the time it took to reduce percent activity by half.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population||hours||Standard Deviation|Mean
63115|NCT01178294|Secondary|PK Analysis- Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Measurable Concentration|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. AUC was calculated as area under the percent activity-time curve.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population||percent activity*hours||Standard Deviation|Mean
80386|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|24 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
63116|NCT01178294|Secondary|PK Analysis- Volume of Distribution (Vd) at Steady State|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population||U/percent activity||Standard Deviation|Mean
63117|NCT01178294|Secondary|Pharmacokinetics (PK) Analysis- Plasma Clearance|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population (= all subjects in the ITT population who consent to PK draws and have factor VIII levels measured at the central reference laboratory)||U/(percent activity*hours)||Standard Deviation|Mean
63118|NCT01178294|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode||Through 90 days ± 7 days following final OBI-1 dose|Because of expected sparseness of positive anti-OBI-1 antibody titers, formal statistical analyses of correlation were not performed.|||||
63119|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|29 subjects (ITT population) had responses available at 24 hours after initial infusion of OBI-1.||participants with bleeds controlled|||Number
63120|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at 16 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|All 19 subjects in the ITT population (n=29) who had responses available at 16 hours after initial infusion of OBI-1 had a positive response.||subjects with eventual bleed control|||Number
63121|NCT01178294|Secondary|Correlation Between Positive Response to OBI-1 Therapy at 8 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|Of 21 subjects in the ITT population (n=29) with responses available at 8 hours after initial infusion of OBI-1, 20 had a positive response.||subjects with eventual bleed control|||Number
63122|NCT01178294|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.||infusions per participant||Standard Deviation|Mean
63123|NCT01178294|Secondary|Total Dose of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.||dose in U/kg||Standard Deviation|Mean
63124|NCT01178294|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes|'Frequency of infusions' was calculated as the 'average number of infusions per day'. 'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.||average number of infusions per day||Standard Deviation|Mean
63125|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|16 hours|19 subjects of the ITT population (n=29) had responses available at 16 hours after initial infusion of OBI-1.||percentage of serious bleeding episodes|Participants|95% Confidence Interval|Number
63126|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|8 hours|21 subjects of the ITT population (n=29) had responses available at 8 hours after initial infusion of OBI-1.||percentage of serious bleeding episodes|Participants|95% Confidence Interval|Number
63127|NCT01178294|Secondary|Overall Percentage of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator|Treatment success was defined as control of qualifying bleeding episode at the time of final treatment dosing. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|At the time of final treatment dosing (varied from participant to participant depending on bleeding episodes)|ITT population = 29 subjects with initial serious bleeding episodes (BEs)||percentage of serious bleeding episodes|Participants|95% Confidence Interval|Number
63128|NCT01178294|Primary|Percentage of Serious Bleeding Episodes Responsive to OBI-1|"The initial serious (qualifying) bleeding episode for each subject was analyzed for the primary efficacy outcome measure. A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'."|24 hours after initiation of treatment|Intent to Treat (ITT) population = 29 subjects with initial serious bleeding episodes||percentage of serious bleeding episodes|Participants|95% Confidence Interval|Number
63131|NCT01178281|Secondary|FACT-Anemia Quality of Life Questionaire|The FACT-An questionnaire is a cancer-specific questionnaire measuring the four general domains of quality-of-life and an additional anemia questionnaire.|Up to treatment discontinuation||08/2018||||
63132|NCT01178281|Secondary|Euro QOL 5 Dimension Questionaire|The EQ-5D is a standardized instrument that measures health outcomes for a wide range of health conditions.|Up to treatment discontinuation||08/2018||||
63133|NCT01178281|Secondary|Healthcare Resource Utilization|"Characterization of medical resource utilization among participants treated with pomalidomide as compared to subjects receiving placebo treatment.~Information on the length of each hospitalization and other major outpatient resource use will be collected at designated study visits, including major diagnostic procedures and other interventions such as those required for transfusions or for treatment-related adverse events. Additionally, information on major categories of concomitant medications (eg., use of G-CSF, intravenous antibiotics, anti-virals, iron chelation) will be obtained."|Every 28 days||08/2018||||
63134|NCT01178281|Secondary|Time to Becoming RBC-transfusion-independent|Number of days from randomization to achieving RBC transfusion independence as assessed every 28 days.|Up to 2.5 years||08/2018||||
63135|NCT01178281|Secondary|Duration of RBC-transfusion Independence|Number of days from randomization to achieving RBC transfusion independence as assessed every 28 days.|Up to 2.5 years||08/2018||||
63136|NCT01178281|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence|"Defined as the absence of intravenous RBC transfusions for any consecutive rolling 84 day interval (i.e. days 1 to 84, days 2 to 85 etc) before Day 169 visit. A responder is: a. One who received at least two RBC transfusions on/after the first dose of study drug, and at least one ≥ 84 days between two consecutive RBC-transfusions; b. One who received at least one RBC transfusion after the first dose of study drug and no RBC transfusion at the first study drug day, and the time interval between the first dose of study drug and the RBC transfusion date is ≥ 84 days; c. One who received at least one RBC transfusion on/after the first dose of study drug and the time interval between the last RBC transfusion and the last transfusion assessment date is ≥ 84 days; d. One who did not receive any RBC transfusions on and after the first dose of study drug, and the time interval between the first dose of study drug and the date of the last transfusion assessment is ≥ 84 days"|168 days|Intent to Treat Population (ITT) includes all participants that were randomized to either of the two study drugs, regardless of whether or not any study drug was actually taken.||percentage of participants||95% Confidence Interval|Number
63137|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63138|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63139|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63140|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63141|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients Without Diabetic Disease|Ischemia-driven target lesion revascularization rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63142|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients With Diabetic Disease.|Ischemia-driven target lesion revascularization rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63143|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63144|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63145|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63146|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63147|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease|The composite of ST, all death, and all MI rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63148|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.|The composite of ST, all death, and all MI rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63149|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Vessel Treated Subgroup|ID-TVF rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63150|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Vessel Treated Subgroup|ID-TVF rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63151|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Lesion Treated Subgroup|ID-TVF rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63152|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Lesion Treated Subgroup|ID-TVF rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63153|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients Without Diabetic Disease|ID-TVF rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63154|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients With Diabetic Disease|ID-TVF rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63155|NCT01178268|Secondary|Acute Gain||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
63156|NCT01178268|Secondary|Percent Diameter Stenosis (%DS)||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.||Percent Diameter stenosis|Participants|Standard Deviation|Mean
63157|NCT01178268|Secondary|Percent Diameter Stenosis||pre procedure|The number of participants with angiographic follow up available was analysed.||percent Diameter stenosis|Participants|Standard Deviation|Mean
63158|NCT01178268|Secondary|Follow-up In-segment Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|Participants||Number
63159|NCT01178268|Secondary|Follow-up In-segment Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.||percent Diameter stenosis|Participants|Standard Deviation|Mean
63160|NCT01178268|Secondary|Follow-up In-segment Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
63161|NCT01178268|Secondary|Follow-up In-stent Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|Participants||Number
63162|NCT01178268|Secondary|Follow-up In-stent Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.||percent Diameter stenosis|Participants|Standard Deviation|Mean
63163|NCT01178268|Secondary|Follow-up In-stent Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
63164|NCT01178268|Secondary|Follow-up Late Loss|This is one of the Secondary Angiographic Endpoint.|≥13 months.|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
63165|NCT01178268|Secondary|XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire|A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.|During the procedure|||percentage of participants|||Number
63166|NCT01178268|Secondary|Fluoroscopy Time|This is the procedure related endpoint.|On day 0, during the procedure.|||Minutes||Standard Deviation|Median
63167|NCT01178268|Secondary|Amount of Contrast Used|Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.|||Milliliter||Standard Deviation|Median
63168|NCT01178268|Secondary|Procedure Time|This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.|||Minutes||Standard Deviation|Median
63169|NCT01178268|Secondary|Acute Procedure Success|Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non–Q-wave), or repeat revascularization of the target lesion during the hospital stay.|< or = 1 day|||percentage of participants|||Number
63170|NCT01178268|Secondary|Acute Device Success|Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.|< or = 1 day|||percentage of participants|Participants||Number
63171|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63172|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63173|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63174|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63175|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63192|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63193|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63194|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63176|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Overall (0 - 772 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63177|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Very late (366 – 772 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63178|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Late (31 – 365 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63179|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Early (0 – 30 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63180|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Subacute (1 – 30 days)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63181|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Acute (<1 day)|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63182|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63183|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63184|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63185|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63186|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63187|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63188|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63189|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63190|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63191|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
86864|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose|15 min FEV1 value|15 min|||L||Standard Deviation|Mean
63197|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63198|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63199|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63200|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63201|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63202|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)|One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63203|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63204|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||9 Months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63205|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||6 Months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63206|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||30 Days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63207|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63208|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63209|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63210|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63211|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63212|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63213|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63214|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63215|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63216|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63217|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63218|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63219|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63220|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63221|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63222|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63223|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63224|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63225|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63226|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63227|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63228|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63229|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63230|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63231|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63232|NCT01178268|Secondary|Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|The is the major Secondary Efficacy Endpoint.|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants||95% Confidence Interval|Number
63233|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)||24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63234|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)||9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63235|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave).||6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63236|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave).||30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63237|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|24 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63238|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|9 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63239|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).|6 months|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63240|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|30 days|The number of participants with angiographic follow up available was analysed.||percentage of participants|||Number
63241|NCT01178268|Primary|Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)|The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non–Q-wave).|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants||95% Confidence Interval|Number
63242|NCT01178268|Primary|Ischemia-driven Target Vessel Failure (ID-TVF)|This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).|12 months|The number of participants with angiographic follow up available was analysed.||percentage of participants||95% Confidence Interval|Number
63243|NCT01178268|Primary|In-stent Late Loss (LL)|"This is the primary angiographic endpoint.~In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)"|>=13 months|The number of participants with angiographic follow up available was analysed.||Millimeter|Participants|Standard Deviation|Mean
63244|NCT01178138|Primary|Blood Pressure Effects of Prazosin on Methamphetamine|"Blood pressure effects of prazosin on methamphetamine;~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The blood pressure was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the blood pressure was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine|||mmHg||Standard Deviation|Mean
63245|NCT01178138|Primary|Heart Effects of Prazosin on Methamphetamine|"Heart effects of prazosin on methamphetamine;~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The heart rate was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the heart rate was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine|||beats per minute||Standard Deviation|Mean
63246|NCT01178138|Primary|Self-report Effects of High.|"Visual analog scales measuring effects prazosin on methamphetamine; change in methamphetamine high. Visual analog scales allow the subject to give a rating of methamphetamine effects. For instance, how high the dose makes you . The study tested how much prazosin changed the effects of methamphetamine as measured by these visual analog scales.~Visual analog scale is a 100 mm scale, ranging from 0 (no effect) to 100 (maximum effect).~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The visual analog scale was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the visual analog scale was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine|||units on a scale||Standard Deviation|Mean
63247|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle and in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in BMI decile group.||percentage of pregnancies|||Number
63248|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in BMI decile group.||percentage of pregnancies|||Number
63249|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in BMI decile group.||percentage of pregnancies|||Number
63250|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in body weight decile group.||percentage of pregnancies|||Number
63251|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in body weight decile group.||percentage of pregnancies|||Number
63252|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in the body weight decile group.||percentage of pregnancies|||Number
63253|NCT01178125|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other BCMs, including condoms, were used, and who were deemed to be compliant, per protocol.||pregnancies / cumulative exposure||95% Confidence Interval|Number
63254|NCT01178125|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used, and who were deemed to be compliant, per protocol.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
63255|NCT01178125|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
63256|NCT01178125|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.||pregnancies / cumulative exposure||95% Confidence Interval|Number
63257|NCT01178125|Other Pre-specified|Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint|A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris.|Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)|Subset of participants with sufficient tissue at both Baseline and Endpoint biopsies.||participants|||Number
63267|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by light transmission aggregometry (LTA) at 6 minutes after the addition of 20 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
80387|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|4 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
63258|NCT01178125|Other Pre-specified|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event.|Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.|Safety population (received at least 1 dose of DR-102)||participants|||Number
63259|NCT01178125|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
63260|NCT01178099|Secondary|P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12|"PRU-derived VN percent inhibition is calculated as a percent decrease of PRU from baseline using the following formula:~([PRU at baseline – PRU at time of post baseline] / PRU at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
63261|NCT01178099|Secondary|Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12|Percent aggregation was assessed by Plateletworks® ADP assay, a whole blood-based test of platelet aggregation for the assessment of platelet inhibition. The assay determines the change in single platelet count due to activation and aggregation by ADP and inhibition thereof by antiplatelet agents.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
63262|NCT01178099|Secondary|Change From Baseline in the Area Under the Aggregation Curve at Day 12|AUC to 20 micromolar (μM) adenosine diphosphate (ADP), 6.5μM ADP, Collagen, and thrombin receptor activator for peptide 6 (TRAP-6) were calculated by whole blood multi-electrode aggregometry (MEA) assay. Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve, measured in aggregation units*minutes (AU*min).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||aggregation units*minutes (AU*min)||Standard Deviation|Mean
63263|NCT01178099|Secondary|Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12|PRI was calculated by vasodilator-associated phosphoprotein (VASP) phosphorylation assay using flow cytometry (FC) and a VASP assay using enzyme-linked immunosorbent assay (ELISA). The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percentage PRI||Standard Deviation|Mean
63264|NCT01178099|Secondary|Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
63265|NCT01178099|Secondary|Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251|Cmax was observed from the data and used to calculate geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
63266|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:~([MPA at baseline – MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
63318|NCT01177735|Secondary|Gene Expression Profiling (GEP) Changes Exerted Within 48 Hours of Initiation 3 Concurrent Days of Exposure to Lenalidomide.|Gene expression profiling at 48 hours after initiation of lenalidomide|48 hours||||||
87249|NCT00935883|Primary|Decrease in Drusen Volume||6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||mm^3||Standard Deviation|Mean
63268|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
63269|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:~([MPA at baseline – MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent inhibition||Standard Deviation|Mean
63270|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by LTA at 6 minutes after the addition of 5 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
63271|NCT01178099|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel’s Inactive Metabolites, R-95913, R-106583, and R-119251|AUC was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
63272|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 5 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||percent aggregation||Standard Deviation|Mean
63273|NCT01178099|Primary|Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727|Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
63274|NCT01178099|Primary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel’s Active Metabolite, R-138727|The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Time of dosing up to 8 hours post-dose on Day 1 and Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
63275|NCT01178073|Secondary|Change From Baseline in Borg Dyspnea Index at Week 24|Borg Dyspnea Index (BDI) indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI was calculated by using the Borg category (C) ratio (R) CR10 scale which starts at 0 (nothing at all) and has no upper limit (extremely strong). Change from BL was calculated as the Week 24 values minus the BL value. The BDI scale was assessed by each participant. The BL BDI score is the average of the two BDI values obtained following the two 6MWD tests used in determining the BL 6MWD. A negative change from BL in the BDI score represented an improvement for the participant. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline (BL) and Week 24|mITT Population. Only participants with Baseline data were analyzed.||Scores on a scale||Inter-Quartile Range|Median
63276|NCT01178073|Secondary|Change From Baseline in the World Health Organization Functional Class at Week 24|The WHO Functional Class (FC) indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). Baseline WHO FC is the latest assessment prior to dosing (i.e., at Randomization or Screening). Change from Baseline at Week 24 was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observations was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.||Scores on a scale||Inter-Quartile Range|Median
63277|NCT01178073|Secondary|Change From Baseline in the 6 Minute Walk Distance Test at Week 24|The 6-minute walk distance (6MWD) test measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned a rank reflecting the relative order of the actual event times. Baseline 6MWD comprised of an average of the last two consecutive measurements prior to randomization that varied by no greater than 10%. If only one measurement was available, that measurement was used. If no two consecutive measures vary by no greater than 10% then Baseline was based on the last two consecutive measures for a participant.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.||Meters||95% Confidence Interval|Median
63278|NCT01178073|Secondary|Percentage of Participants With a Satisfactory Clinical Response at Week 24|A satisfactory clinical response at Week 24 is defined as a participant who meets all of the following criteria: 10% improvement in 6MWD compared with Baseline; improvement to or maintenance of World Health Organization (WHO) class I or II symptoms; no events of clinical worsening prior to or at the Week 24 visit. Clinical worsening events included: death, hospitalization for pulmonary arterial hypertension (PAH), and disease progression. Participants without an event of clinical worsening prior to or at the Week 24 visit who did not have a 6MWD value or a WHO functional class value at Week 24 were excluded from the analysis.|Baseline and Week 24|"mITT Population. Only those participants who had a Yes/No response were analyzed."||Percentage of participants|||Number
63279|NCT01178073|Secondary|Percent Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Week 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate marker of heart failure. The data were log-transformed. The geometric mean was calculated (based on the log-transformed data). The geometric mean ratio was calculated as the ratio between the Week 24 value and the Baseline value (based on the log-transformed data) and presented as percent change = 100 * (geometric mean ratio – 1). The Baseline value is the last value prior to administration of study drug; this may be prior to or on the day of study drug initiation. No imputation was performed for missing data. The secondary endpoints were analyzed according to a pre-specified hierarchical testing procedure.|Baseline and Week 24|mITT Population. Only participants with data available at the specified time points were analyzed.||Percent change||Standard Error|Mean
63280|NCT01178073|Primary|Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV|Time to the first adjudicated CF event (death, hospitalization for worsening pulmonary arterial hypertension [PAH], disease progression, or unsatisfactory long-term clinical response) after initiating either first-line combination therapy with AMB and TAD or first-line monotherapy with either drug (AMB or TAD) in par. with PAH was assessed. If data was not available for some par. following a loss to follow-up, their event times were treated as censored at their last assessment time for the statistical analyses. FAV occurred approximately 4 weeks after the predicted 105th adjudicated first CF event was reached. Par. who had an FAV, and who had no adjudicated events or whose first adjudicated event occurred after their FAV, were censored at their individual FAV. Modified Intent-to-Treat (mITT) Population: all randomized par. who met the PAH diagnosis and inclusion/exclusion criteria defined in protocol amendment 2 and who also received at least one dose of investigational product (IP).|From Baseline up to the Final Assessment Visit (FAV) (average of 609 days)|mITT Population||Participants|||Number
63281|NCT01177969|Secondary|Anxiety Disorders Interview Schedule: Child and Parent Versions|The Anxiety Disorders Interview Schedule: Child and Parent Versions are clinician-rated scales assessing anxiety symptoms and the associated severity and impairment in children over the past month. The clinician interviewer interviews the child and parent separately about the nature and severity of the child's anxiety. If a child meets criteria for an anxiety disorder, a single item is rated by the interviewer, which represents anxiety severity. The scale score for this single item ranges from 0 to 8 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which was an average of 16 weeks after Baseline|||units on a scale||Standard Deviation|Mean
63282|NCT01177969|Primary|Pediatric Anxiety Rating Scale.|The Pediatric Anxiety Rating Scale is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale includes 5 items which are summed to form a total score, which represents anxiety severity. The scale score ranges from 0 to 25 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which is an average of 16 weeks after Baseline|||units on a scale||Standard Deviation|Mean
63283|NCT01177956|Secondary|Duration of Response Until Cut-off Date 15 November 2012|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|Subgroup of participants from the study population having best confirmed response (CR or PR).||months||95% Confidence Interval|Median
63284|NCT01177956|Secondary|Duration of Response Until Cut-off Date 25 January 2011|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|Subgroup of participants from the study population having best confirmed response (CR or PR).||months||95% Confidence Interval|Median
63285|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 15 November 2012|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
63319|NCT01177735|Secondary|Gene Expression Profiling (GEP) Changes Exerted Within 48 Hours of Initiation of Daily Pomalidomide Dosing.|Gene expression profiling at baseline and at 48 hours after initiation of pomalidomide|48 hours||||||
63286|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 15 November 2012|BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or chemotherapy.||percentage of participants||95% Confidence Interval|Number
63287|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 25 January 2011|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
63288|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
63289|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
63290|NCT01177956|Secondary|Overall Survival (OS) Time Until Cut-off Date 15 November 2012|The OS time was defined as the time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||months||95% Confidence Interval|Median
63291|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 25 January 2011|BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization [WHO] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.||percentage of participants||95% Confidence Interval|Number
63292|NCT01177943|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]|The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had an AUC value were included in the AUC analysis.||nanogram hour per milliliter (ng*h/mL)||90% Confidence Interval|Least Squares Mean
63293|NCT01177943|Primary|Maximum Observed Plasma Concentration (Cmax)|The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had a Cmax value were included in the Cmax analysis.||nanogram per millileter (ng/mL)||90% Confidence Interval|Least Squares Mean
63294|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the MAdCAM-1-Fc marker. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"||percent inhibition*days||Standard Deviation|Mean
63295|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the Act-1 marker. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"||percent inhibition*days||Standard Deviation|Mean
63320|NCT01177735|Secondary|Response Rate (CR, n-CR, VGPR) and Duration of Response After Pomalidomide Therapy.|Response rate (CR, n-CR, VGPR) Duration of response rate after initiation of pomalidomide therapy|1 year following initiation of pomalidomide therapy||||||
63558|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.||% of participants|||Number
63296|NCT01177228|Primary|Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percent inhibition of the MAdCAM-1-Fc binding to α4β7 integrin due to the presence of vedolizumab binding.~Emax was calculated on Day 1, Day 85, and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"||percent inhibition||Standard Deviation|Mean
63297|NCT01177228|Primary|Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the Act-1 binding interference assay. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percent inhibition of the Act-1 due to the presence of vedolizumab binding.~Emax was calculated on Day 1, Day 85 and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"Pharmacodynamic (PD) Analysis Set, defined as all participants for whom there were sufficient data to estimate PD. Analyses only include participants with available data (indicated by n)."||percent inhibition||Standard Deviation|Mean
63298|NCT01177228|Primary|Terminal Phase Elimination Half-life (t½) of Vedolizumab|Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose through Day 253|PK Analysis Set; participants with available data||days||Standard Deviation|Mean
63299|NCT01177228|Primary|Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab|"AUC was calculated for 3 time intervals during the study:~AUC (Day 0-14): from administration on Day 0 to last quantifiable concentration on Day 14, selected to capture the AUC following the first dose of vedolizumab until administration of the second dose~AUC(Day 85-99): from administration on Day 85 to last quantifiable concentration on Day 99, selected to assess the amount of drug accumulation with the planned loading regimen by comparing it to AUC(Day 0-14)~AUC(Day 85-141): from the first quantifiable concentration on Day 85 to the last quantifiable concentration on Day 141, selected to assess the drug exposure over an 8-week period"|Days 0-14, Days 85-99, Days 85-141|PK Analysis Set; participants with available data at each time point (indicated by “n”).||day*μg/mL||Standard Deviation|Mean
63300|NCT01177228|Primary|Cmin: Minimum Observed Plasma Concentration of Vedolizumab|Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|PK Analysis Set; participants with available data.||μg/mL||Standard Deviation|Mean
63301|NCT01177228|Primary|Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|"Pharmacokinetic (PK) Analysis Set, defined as all vedolizumab participants for whom there were sufficient data to estimate PK. Analyses only include participants with available data at each time point (indicated by n)."||µg/mL||Standard Deviation|Mean
63302|NCT01177228|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.~The intensity for each AE was defined according to the following criteria:~Mild: Awareness of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with normal daily activities Severe: Inability to perform normal daily activities."|From the first date of study drug administration through Day 253|Safety Analysis Set, defined as all enrolled participants who received at least 1 dose of study treatment. One participant was randomized but not dosed and is not included in this population.||participants|||Number
63303|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.|Week 12|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
63304|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.|Week 6|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
63305|NCT01177098|Secondary|Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
63306|NCT01177098|Secondary|Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
63307|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.|Week 2|Intent-to-treat population included all randomized participants.||mm Hg||Standard Deviation|Mean
63308|NCT01177098|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.||mm Hg||Standard Deviation|Mean
63309|NCT01177813|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|"Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.~Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category."|From first drug intake until 7 days after last medication intake, up to 219 days|Treated set (actual) including all patients treated with at least 1 dose of randomised trial medication with some treatment switchers (1 from Empa25 to placebo; 1 patient got Empa 10 at least with one mis-allocated kit) and open-label set||percentage of participants|||Number
63310|NCT01177813|Secondary|Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.~For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored."|Baseline and week 24|FAS and open-label set, last observation carried forward without values following a change in antihypertensive therapy (LOCF- H) was used as the imputation rule||mmHg||Standard Error|Mean
63311|NCT01177813|Secondary|Change From Baseline to Week 24 in Body Weight|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS (LOCF) and open-label set (LOCF)||kg||Standard Error|Mean
63312|NCT01177813|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets||percent of HbA1c||Standard Error|Mean
63313|NCT01177800|Other Pre-specified|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability|The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent’s genetic input) anomaly.|Baseline up to end of study (Week 26)|Safety Population included all participants randomly assigned to infliximab or placebo group.||participants|||Number
63314|NCT01177800|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26|The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 26|ITT population included all participants randomly assigned to Infliximab or placebo group. 'n' included those participants who were evaluable for this measure at specific time points.||units on a scale||Standard Deviation|Mean
63315|NCT01177800|Secondary|Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10|The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score <= 1 at week 10 were reported.|Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group.||percentage of participants|||Number
63316|NCT01177800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group. Here 'n' included those participants who were evaluable for this measure at specific time points.||units on a scale||Standard Deviation|Mean
63317|NCT01177800|Primary|Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI)|The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.|Week 10|Intent to treat (ITT) population included all participants randomly assigned to Infliximab or placebo group.||percentage of participants|||Number
63321|NCT01177735|Primary|Progression-free Survival (PFS) After Initiation of Pomalidomide Therapy|Progression -free survival (PFS) after initiation of pomalidomide therapy. Progressive disease is defined as increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL); Urine M-component and/or (the absolute increase must be > 200 mg/24 h); Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; the absolute percentage must be > 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|1 year following initiation of pomalidomide therapy|||percentage of participants|||Number
63322|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post each vaccination|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).||Participants|||Number
63323|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 after each dose|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).||Participants|||Number
63324|NCT01177722|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).|Day 0 (pre-vaccination) and 30 days post-dose 3|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
63325|NCT01177722|Primary|Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).|30 Days post-dose 3|Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).||Participants|||Number
63326|NCT01177722|Primary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™|Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.|Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
63327|NCT01177709|Secondary|Insulin Level|fasting serum insulin|baseline, 4 weks, 8 weeks, 12 weeks|||serum insulin uIU/ml||Standard Error|Mean
63328|NCT01177709|Secondary|Glucose Levels|Fasting glucose|baseline, 4 weeks, 8 weeks, 12 weeks|||glucose mg/dl||Standard Error|Mean
63329|NCT01177709|Primary|Weight in Lbs.|Patients weight in pounds|baseline, 4 wks, 8 wks, 12 weeks|||wet in pounds||Standard Error|Mean
63330|NCT01177670|Secondary|Safety Endpoints|The Adiana System will be evaluated for safety on the basis of the occurrence of adverse events which are related to the study device, unanticipated or serious.|At one and two years|Intent to treat||participants|||Number
63331|NCT01177670|Primary|Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.|The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.|At one and two years|Efficacy results were not tabulated due to the early termination of the study. Only 169 of the planned 1,000 subjects (16.9%) were enrolled therefore the study is defined as incomplete, as fewer than one-third of the intended patients were enrolled.|||||
63332|NCT01177553|Secondary|Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.||6 months||||||
63333|NCT01177553|Primary|Survival|Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management.|6 months|||percentage of AGA babies who survived|||Number
63370|NCT01176773|Secondary|Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale|Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated for perioral lines||units on a scale||Standard Deviation|Mean
63559|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)||10-14 weeks|||% of participants|||Number
63334|NCT01177410|Primary|The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.||participants|||Number
63335|NCT01177410|Secondary|Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.||participants|||Number
63336|NCT01177384|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 Weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.||Participants|||Number
63337|NCT01177384|Primary|Number of Participants Who Experienced at Least One Adverse Event||Up to Week 24 + 14 Day Post-Study Follow-up|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.||Participants|||Number
63338|NCT01177384|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for the FPG. Last observation carried forward (missing data approach).||mg/dL||95% Confidence Interval|Least Squares Mean
63339|NCT01177384|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).||Percent||95% Confidence Interval|Least Squares Mean
63340|NCT01177293|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
63341|NCT01177293|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
63342|NCT01177293|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Full Range|Geometric Mean
63343|NCT01177293|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
63344|NCT01177293|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
63345|NCT01176968|Secondary|Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.|Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||pg/mL||Inter-Quartile Range|Median
63346|NCT01176968|Secondary|Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.|Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||μg/L||Inter-Quartile Range|Median
63560|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks||10-14 weeks|||(no units; ratio of values)||Inter-Quartile Range|Median
63347|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.|Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||ng/mL||Inter-Quartile Range|Median
63348|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.|Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (carboxyterminal telopeptide of type I collagen [ICTP], procollagen type I N-terminal peptide [PINP], procollagen type III N-terminal peptide [PIIINP], Interleukin-6, aldosterone, cortisol, and Galactin 3) available.||nmol/L||Inter-Quartile Range|Median
63349|NCT01176968|Secondary|Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).|LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Centimeters (cm)||Standard Deviation|Mean
63350|NCT01176968|Secondary|Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.|Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.|6 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Milliseconds (msec)||Standard Deviation|Mean
63351|NCT01176968|Secondary|Second or Subsequent Non-fatal Myocardial Infarction (MI).|The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
63352|NCT01176968|Secondary|Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).|The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Events|||Number
63353|NCT01176968|Secondary|Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).|The occurrence of first occurrence of BNP >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for ages <50 years, 50 to 75 years and >75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.||Events|||Number
63354|NCT01176968|Secondary|First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).|The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.||Events|||Number
63355|NCT01176968|Secondary|First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.|The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
63356|NCT01176968|Secondary|Diagnosis of Heart Failure|The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
87271|NCT00935766|Secondary|Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)||baseline, 3 months|||ng/mL||Standard Deviation|Mean
63357|NCT01176968|Secondary|Cardiovascular Mortality|The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.||Events|||Number
63358|NCT01176968|Primary|First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off|Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.|0-24 months|The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.||Events|||Number
63359|NCT01176955|Primary|Adherence to Study Medication|Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported.|12 weeks|||Percent of prescribed doses taken||Full Range|Median
63360|NCT01176955|Secondary|The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.|All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.|12 weeks||||||
63361|NCT01176955|Secondary|The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.|Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps.|12 weeks||||||
63362|NCT01176955|Secondary|The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.|Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.|Baseline to 12 weeks|||percent change in lesion count||Standard Deviation|Mean
63363|NCT01176955|Secondary|The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.|Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.|Baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
63364|NCT01176877|Secondary|To Assess the Impact of an Educational Lecture on Long-term Knowledge Retention About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and 3 Months After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|before and 3 months after a 5 minute educational lecture|Patients enrolled who were available for phone contact 3 months following intervention.||score on a scale||Full Range|Mean
63365|NCT01176877|Primary|To Assess the Impact of an Educational Lecture on Knowledge About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and Immediately After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|immediately before and after a 5 minute educational lecture|||score on a scale||Full Range|Mean
63366|NCT01176773|Secondary|Adverse Events||12 months|Intent-to-treat||percentage of subjects|||Number
63367|NCT01176773|Secondary|Number of Subjects Who Attain Their Lip Treatment Goal|"Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding yes as to whether their pre-established lip fullness treatment goal had been attained."|1-12 months|All subjects who provided a lip fullness goal achievement assessment||percentage of subjects|||Number
63368|NCT01176773|Secondary|Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale|The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result.|3 months|All subjects with a Look and Feel assessment||percentage of subjects|||Number
63369|NCT01176773|Secondary|Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale|Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated in their oral commissures||units on a scale||Standard Deviation|Mean
63371|NCT01176773|Primary|Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale|The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment|3 months|Intent-to-treat||percentage of responders||95% Confidence Interval|Number
63372|NCT01176513|Secondary|To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.|Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.|After GE-148 (18F) Injection administration|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.|||||
63373|NCT01176513|Primary|To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.|Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.|After GE-148 (18F) Injection administration.|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.|||||
63374|NCT01176448|Secondary|Visual Analog Scale for Assessing Scar Improvement.|"Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement~: 1-25% improvement~: 26-50% improvement~: 51-75% improvement~: 76-100% improvement"|3 months|"With 12 pairs of scars gave a 95% probability to detect a treatment difference at a two sided 0.05 significance level if a significant difference between treatments is 1.5 units (based on a 0~–4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units."||units on a scale|Participants|Standard Deviation|Mean
63375|NCT01176448|Primary|Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing|Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.|Day 0, Week1, Month 1|Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion.||units on a scale|Participants|Standard Error|Mean
63376|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|1 year|||degrees||Standard Deviation|Mean
63377|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|4-6 months|||degrees||Standard Deviation|Mean
63378|NCT01176292|Secondary|Oxford Knee Score|A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.|1 year|||score||Standard Deviation|Mean
63379|NCT01176292|Secondary|Knee Society Score|A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.|1 year|||score||Standard Deviation|Mean
63380|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|1 year|||degrees||Standard Deviation|Mean
63381|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|preoperative, 4-6 weeks|||degrees||Standard Deviation|Mean
63382|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|Preoperative, 4-6 weeks|||degrees||Standard Deviation|Mean
63383|NCT01176240|Post-Hoc|Study 306A: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) From Baseline to Week 1|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|Last observation carried forward was used to impute missing values.||units on a scale||Standard Deviation|Mean
63384|NCT01176240|Secondary|306B Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|The primary analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.||units on a scale||Standard Deviation|Mean
63385|NCT01176240|Secondary|306B Efficacy: Rate of Patient Reported Falls|The average number of patient reported falls per week.|up to 10 weeks|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.||falls per week||Standard Deviation|Mean
63440|NCT01175850|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.||Days||Standard Deviation|Mean
63386|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 8 (Visit 7)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 8 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 8|The analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.||units on a scale||Standard Deviation|Mean
63387|NCT01176240|Secondary|306B Efficacy: Change in Systolic Blood Pressure (SBP) Measurements Post Standing From Baseline to Week 1|Measure: Lowest standing systolic blood pressure reading of immediately post standing and 3 minutes post standing. Change: standing systolic blood pressure at Week 1 (Visit 4) minus standing systolic blood pressure at baseline. A positive score indicates an improvement in standing systolic blood pressure during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|One droxidopa patient did not complete the standing blood pressure measurements of the orthostatic standing test at visit 4 (one week of stable dosing)||mmHg||Standard Deviation|Mean
63388|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 4 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week4|||units on a scale||Standard Deviation|Mean
63389|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 2 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week2|||units on a scale||Standard Deviation|Mean
63390|NCT01176240|Post-Hoc|306A Efficacy: Patient Reported Falls|The total number of patient reported falls during the 8 week treatment period|Baseline, Week 8|||total falls per group|||Number
63391|NCT01176240|Primary|306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week1|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.||units on a scale||Standard Deviation|Mean
63392|NCT01176240|Primary|306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The primary efficacy endpoint for 306A is the relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|LOCF was used to impute values for patients who did not have an end of study visit.||units on a scale||Standard Deviation|Mean
63393|NCT01176058|Secondary|Number of Participants Who Died||Baseline to Day 52|Safety population: All participants who have received at least one dose of study medication.||participants|||Number
63394|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at Follow-Up|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.||percentage of participants||95% Confidence Interval|Number
63395|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.||percentage of participants||95% Confidence Interval|Number
63396|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOIT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure.||percentage of participants||95% Confidence Interval|Number
63441|NCT01175850|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
63442|NCT01175850|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
63397|NCT01176058|Secondary|Percentage of Participants With Clinical Response at Follow-Up|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.||percentage of participants||95% Confidence Interval|Number
63398|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.||percentage of participants||95% Confidence Interval|Number
63399|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOIT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.||percentage of participants||95% Confidence Interval|Number
63400|NCT01176058|Secondary|Percentage of Participants With Global Response at End of Treatment (EOT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).~Failure – Any case that did not meet the criteria for success."|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.||percentage of participants||95% Confidence Interval|Number
63401|NCT01176058|Primary|Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response).~Failure – Any case that did not meet the criteria for success."|End of Intravenous Treatment (Up to Day 42)|Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.||percentage of participants||95% Confidence Interval|Number
63402|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs|The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide|Baseline, Week 10,18,26|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||Patients|||Number
63403|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline|The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline|Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||Patients|||Number
63404|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate|Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)|Baseline, Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||Patients|||Number
63405|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||mmHg||Standard Deviation|Mean
63406|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||mmHg||Standard Deviation|Mean
63407|NCT01176032|Secondary|Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||g/m2||Standard Deviation|Mean
63408|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||cm3/m^2||Standard Deviation|Mean
63409|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||mm/m^2||Standard Deviation|Mean
63410|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||Percent||Standard Deviation|Mean
63411|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ml||Standard Deviation|Mean
63412|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine|The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/dl||Standard Deviation|Mean
63413|NCT01176032|Secondary|Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/ml||Standard Deviation|Mean
63414|NCT01176032|Secondary|Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment||g/m^2||Standard Deviation|Mean
63415|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||cm3/m^2||Standard Deviation|Mean
63416|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||mm/m^2||Standard Deviation|Mean
63417|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||Percent||Standard Deviation|Mean
63418|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ml||Standard Deviation|Mean
63419|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease|The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/dl||Standard Deviation|Mean
63420|NCT01176032|Secondary|Change From Baseline in Biomarkers in Heart Disease|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.||ng/ml||Standard Deviation|Mean
63421|NCT01176032|Primary|Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)|PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment.||ug/l||Standard Deviation|Mean
63422|NCT01175902|Secondary|OPP, Period 2|"OPP was calculated according to the following formula:~OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP~OPP after treaemt from week 8 to week 12"|12 weeks|||mmHg||Standard Deviation|Mean
63423|NCT01175902|Secondary|Ocular Perfusion Pressure (OPP), Period 1|"OPP was calculated according to the following formula:~OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP"|4 weeks|||mmHg||Standard Deviation|Mean
63424|NCT01175902|Primary|Blood Pressure (BP), Period 2|systolic and diastolic BP measured after treaemt from week 8 to week 12|12 weeks|||mmHg||Standard Deviation|Mean
63425|NCT01175902|Primary|Blood Pressure (BP), Period 1|systolic and diastolic BP at 4 weeks after use of eyedrops|4 weeks|||mmHg||Standard Deviation|Mean
63426|NCT01175902|Primary|Intraocular Pressure (IOP), Period 2|IOP (mean IOP) after treaemt from week 8 to week 12|12 weeks|||mmHg||Standard Deviation|Mean
63427|NCT01175902|Primary|Intraocular Pressure (IOP), Period 1|IOP (mean IOP) after 4 weeks of treatment|4 weeks|||mmHg||Standard Deviation|Mean
63428|NCT01175850|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Days||Standard Deviation|Mean
63429|NCT01175850|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, stroke, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (ITT) (n=331)||Percentage of participants|||Number
63430|NCT01175850|Secondary|Procedural Success|Procedural success is defined as obtainment of ≤30% residual stenosis by visual estimate (with or without stenting)|Day 1|Intention-to-Treat (ITT) (n=331)||Percentage of participants|||Number
63431|NCT01175850|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).||Percentage of devices|Devices||Number
63432|NCT01175850|Secondary|Change From Baseline in Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) at 12 Months|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.~Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
63433|NCT01175850|Secondary|Change From Baseline in Quality of Life Assessment by EuroQol Group 5-Dimension Self Report Questionnaire (EQ5D) at Month 12|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.~EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|Baseline to 12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Units on a scale||Standard Deviation|Mean
63434|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio >3.4).||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of particpants|||Number
63435|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4).|Duplex ultrasound measurement that measures the peak systolic velocity of blood (cm/sec) within a lesion divided by the peak velocity of blood (cm/sec) proximal to the lesion.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
63436|NCT01175850|Secondary|Secondary Sustained Clinical Improvement|Freedom from target limb amputation and increase in Rutherford class.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of participants|||Number
63437|NCT01175850|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class. Rutherford classification is a clinical staging system that is used to describe peripheral arterial disease.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of particpants|||Number
63438|NCT01175850|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
63439|NCT01175850|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||percentage of amputations|||Number
63444|NCT01175850|Secondary|Major Adverse Events (MAE) Composite|Major Adverse Events (MAE) composite defined as all-cause death, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, thrombosis at the target lesion site|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
63445|NCT01175850|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of Participants|||Number
63446|NCT01175850|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.|12 Month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.||Percentage of participants|||Number
63447|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
63448|NCT01175824|Secondary|The Number of Participants With Severe Hypoglycemic Episodes|The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.||participants|||Number
63449|NCT01175824|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
63450|NCT01175824|Secondary|Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks|PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had PAM-D21 scores at 24 weeks.||units on a scale||95% Confidence Interval|Least Squares Mean
63451|NCT01175824|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks|ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had ITSQ scores at 24 weeks. Last observation carried forward (LOCF).||units on a scale||95% Confidence Interval|Least Squares Mean
63452|NCT01175824|Secondary|The Number of Participants With a Hypoglycemic Episodes (Incidence)|A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of <= 70 milligrams per deciliter [mg/dL, 3.9 millimoles per liter (mmol/L)].|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.||participants|||Number
63453|NCT01175824|Secondary|Change in Weight From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug and had evaluable body weight data at the specified time points.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
63454|NCT01175824|Secondary|Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks||12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had dosing data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||international units (IU)||Standard Deviation|Mean
63464|NCT01175811|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.||International Units per kilogram (IU/kg)||Standard Deviation|Mean
63561|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|||% (absolute change)||Inter-Quartile Range|Median
63455|NCT01175824|Secondary|Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG glycemic variability data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||millimoles/liter (mmol/L)||95% Confidence Interval|Least Squares Mean
63456|NCT01175824|Secondary|7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
63457|NCT01175824|Secondary|Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, and 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had fasting plasma glucose concentration data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
63458|NCT01175824|Secondary|Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks||24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||participants|||Number
63459|NCT01175824|Secondary|Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint|The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at the 12 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
63460|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Per protocol population: randomized participants with the exception of participants who did not complete Week 24 visit, received study drug different from their randomized study treatment, violated any of the inclusion, exclusion, or discontinuation criteria, or were significantly noncompliant.||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
63461|NCT01175811|Secondary|Percentage of Participants Experiencing a Severe Hypoglycemic Episode|Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.||Percentage of participants|||Number
63462|NCT01175811|Secondary|The Rate of Hypoglycemic Episodes|The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.||hypoglycemic episode/30 days/participant||Standard Error|Mean
63463|NCT01175811|Secondary|Percentage of Participants With Hypoglycemic Episodes (Incidence)|Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.||percentage of participants|||Number
63562|NCT01175018|Secondary|Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)||10-14 weeks|||% (absolute change)||Inter-Quartile Range|Median
63465|NCT01175811|Secondary|Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had baseline and at least 1 post-baseline BMI data.||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
63466|NCT01175811|Secondary|Daily Dose of Insulin: Total, Basal, and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.||International Units (IU)||Standard Deviation|Mean
63467|NCT01175811|Secondary|The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
63468|NCT01175811|Secondary|The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks|The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.|12 weeks, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study.||Percentage of participants|||Number
63469|NCT01175811|Secondary|Change in HbA1c From Baseline to 12 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 12 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and who had a baseline and at least 1 post-baseline evaluable HbA1c data.||percent HbA1c||95% Confidence Interval|Least Squares Mean
63470|NCT01175811|Primary|Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.||percent HbA1c||95% Confidence Interval|Least Squares Mean
63471|NCT01175798|Secondary|Change in Immune Parameters|Secondary outcomes to be measured include change in peripheral blood mononuclear cell (PBMC) profile by flow cytometry at 6 and 12 months, change in ELISPOT-based panel of reactive T cell (PRT) readout at 6 and 12 months, change in PMBC cytokine production in response to toll-like-receptor stimulation at 6 and 12 months, and response to influenza vaccination.|1 year||||||
63472|NCT01175798|Primary|Change in 25OH-Vitamin D Level|Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months.|1 year|||ng/dL||Inter-Quartile Range|Median
63473|NCT01175707|Secondary|Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant|Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.|Day 1 up to Day 14|All study participants.||US Dollars||Standard Deviation|Mean
63474|NCT01175707|Secondary|Number of Laboratory Assessment Types During Home Infusion Therapy|There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough|Day 1 up to Day 14|All study participants.||Assessments|||Number
63475|NCT01175707|Secondary|Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.|Day 1 up to Day 14|All study participants.||Assessments||Standard Deviation|Mean
63476|NCT01175707|Secondary|Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.|Day 1 up to Day 14|All study participants.||Participants|||Number
63477|NCT01175707|Secondary|Number of Intervention Types During Home Infusion Therapy|There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention.|Day 1 up to Day 14|All study participants||participants|||Number
63478|NCT01175707|Secondary|Mean Number of Interventions Per Participant During Home Infusion Therapy|Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw.|Day 1 up to Day 14|All study participants.||Interventions||Standard Deviation|Mean
63479|NCT01175707|Secondary|Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy|Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.|Day 1 up to Day 14|All study participants.||Participants|||Number
63514|NCT01175434|Secondary|Feasibility and Acceptability|We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.|one year||||||
63480|NCT01175707|Primary|Percentage of Treatment Goals Met at End of Therapy|"Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic.~Each participant’s percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants’ percentage of goals met by arm."|Day 1 up to Day 14|All study participants.||Percentage of Goals Met||Standard Deviation|Mean
63481|NCT01175707|Primary|Reasons for Pharmacist Consultations During Home Infusion Therapy|The reason for a participant’s pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.|Day 1 up to Day 14|All study participants.||Reason Cited|||Number
63482|NCT01175707|Primary|Reasons for Nurse Visits During Home Infusion Therapy|The reason for a participant’s nurse visit is presented. There may be more than one reason for nurse visits per participant.|Day 1 up to Day 14|All study participants.||Reason Cited|||Number
63483|NCT01175707|Primary|Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy||Day 1 up to Day 14|All study participants.||Participants|||Number
63484|NCT01175707|Primary|Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy||Day 1 up to Day 14|Number of Participants Analyzed based on number of participants with at least one nurse visit/pharmacist consultation within each treatment group results in 39 participants analyzed for the Daptomycin ARM group for this Outcome Measure.||Participants|||Number
63485|NCT01175707|Primary|Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy|Each participant is counted once per category.|Day 1 up to Day 14|All study participants.||Visits or Consultations per Participant||Standard Deviation|Mean
63486|NCT01175707|Primary|Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy|The mean duration in home-infusion antibiotic therapy per participant is presented.|Day 1 up to Day 14|All study participants.||Days||Standard Deviation|Mean
63487|NCT01175707|Primary|Time Spent (Minutes) for Home Infusion Therapy|Each participant is counted once per category. Avg=average; Admin=administer.|Day 1 up to Day 14|All study participants.||Minutes||Standard Deviation|Mean
63488|NCT01175668|Secondary|Total Dose of NMS Used||For the duration of treatment, upto 3 months|||mg/kg||95% Confidence Interval|Mean
63489|NCT01175668|Primary|Length of Treatment With Neonatal Morphine Sulfate||subjects were followed for the duration of treatment, up to 3 months|||days||95% Confidence Interval|Mean
63490|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
63491|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
63492|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
63493|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
63494|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
63495|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)||eyes|Participants||Number
63496|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 11 (Visit 3)|Modified Intent-to-Treat Population||eyes|Participants||Number
63497|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 8 (Visit 2)|Modified Intent-to-Treat Population||eyes|||Number
63498|NCT01175590|Primary|Non-Ocular Treatment-Emergent Adverse Events|Non-Ocular Treatment-Emergent Adverse Events on the Study Eye|7 days|Safety Population||Events|||Number
63499|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 11 (Visit 3)|Study Eye, Modified Intent-to-Treat Population||eyes|Participants||Number
63500|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 8 (Visit 2)|Study Eye, Modified Intent-to-Treat Population||eyes|Participants||Number
63501|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.|Day 11 (Visit 3)|Study eye for the mITT population||eyes|||Number
63502|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data|Day 8 (Visit 2)|Study eye for the mITT population||eyes|Participants||Number
63503|NCT01175590|Primary|Ocular Treatment Emergent Adverse Events|Ocular Treatment-Emergent Adverse Events on the Study Eye|At each visit - 7 days|Safety Population||Events|Participants||Number
63515|NCT01175434|Secondary|Cost Effectiveness|We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.|one year||||||
63504|NCT01175473|Secondary|Percentages of Patients by Ranges of Oxyntomodulin Levels|Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population. Here, 'n' signifies patients with oxyntomodulin assessment at the specified time point.||percentage of participants|||Number
63505|NCT01175473|Secondary|Change From Time-matched Baseline in Obestatin Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.||nmol/L||Standard Deviation|Mean
63506|NCT01175473|Secondary|Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.||pmol/L||Standard Deviation|Mean
63507|NCT01175473|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29|Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1).|Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)|PD population. Here, number of patients analyzed = patients with post-baseline HbA1c assessment.||percentage of hemoglobin||95% Confidence Interval|Least Squares Mean
63508|NCT01175473|Secondary|Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28|The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||h*pg/mL||95% Confidence Interval|Least Squares Mean
63509|NCT01175473|Secondary|Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28|The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||h*ng/mL||95% Confidence Interval|Least Squares Mean
63510|NCT01175473|Secondary|Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28|The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
63511|NCT01175473|Secondary|Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28|The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
63512|NCT01175473|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28|PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.||mg/dL||95% Confidence Interval|Least Squares Mean
63513|NCT01175473|Primary|Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28|The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|Pharmacodynamic (PD) population (modified intent-to-treat [mITT] population) included all randomized patients, who received at least 1 dose of lixisenatide or liraglutide, and had both a baseline assessment and at least 1 post-baseline assessment of any pharmacodynamic variable, irrespective of compliance with the study protocol and procedures.||h*mg/dL||95% Confidence Interval|Least Squares Mean
63516|NCT01175434|Primary|Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)|The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.|Average number of days, over 2 weeks, throughout the school year|||Days||Standard Deviation|Mean
63517|NCT01175395|Secondary|To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis|Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD.|30 to 360 days|||retreatments||Full Range|Median
63518|NCT01175395|Primary|To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD|"The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis.~The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit."|360 Days|||Number-participants with adverse events|||Number
63519|NCT01175369|Secondary|Additional Asthma Morbidity Outcomes|We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.|1-9 months (Monthly Follow-up assessments)||||||
63520|NCT01175369|Secondary|Cost Effectiveness of the Intervention|Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.|approximately 9 months (length of school year)||||||
63521|NCT01175369|Secondary|Cotinine Level|To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).|2 month and approximately 9 month (end of school year) follow-up assessments||||||
63522|NCT01175369|Primary|Number of Symptom Free Days|The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).|Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)|||Days||Standard Deviation|Mean
63523|NCT01175317|Secondary|Average Intraoperative CO2 Gap|"The CO2 gap (difference arterial pCO2 and pCO2 of the stomach lumen) reflects global intestinal perfusion status and is measured every 15 minutes intraoperatively and every 60 minutes during the first 8 hours postoperatively.~Intraoperative measurements were averaged per individual patient, producing the average intraoperative CO2 gap."|Average intraoperative CO2 gap|||kPa||Standard Deviation|Mean
63524|NCT01175317|Primary|Peak Value of I-FABP|"Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma.~The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group."|1 hour postoperatively|||pg/mL||Standard Deviation|Mean
63525|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||Percentage of infusions|Participants||Number
63526|NCT01175213|Secondary|Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (non-SAE) and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
63527|NCT01175213|Secondary|Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (nsAE) and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
63528|NCT01175213|Secondary|Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (“Related”)|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
63529|NCT01175213|Secondary|Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (“Related”)|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
63530|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
63563|NCT01175018|Secondary|Number of Adverse Events in Each Group||10-14 weeks|||adverse events|||Number
63531|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
63532|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious adverse event; SAE- serious adverse event Severity: Mild; Mod (Moderate); Sev (Severe)~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
63533|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
63534|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
63535|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs per participant|||Number
63536|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z).|"Categories presented as Preferred Term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Infection - Inf."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs|||Number
63537|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs|||Number
63538|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~CPK - Creatinine Phosphokinase Inc. - Increased Dis - Disease Sml- small"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set||Number of AEs|||Number
63539|NCT01175213|Secondary|Percentage of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.||Percentage of participants|||Number
63540|NCT01175213|Secondary|Number of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.||Number of participants|||Number
63551|NCT01175031|Secondary|Device Detected Apneas as Detected by Philips Respironics (PR) System One|All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway.|During a single night of polysomnography lasting an average of 8 hours|1097 Device Detected Apneas were detected.||events|Participants||Number
63552|NCT01175031|Primary|Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography|The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared.|During a single night of polysomnography lasting an average of 8 hours|||events/hour||Standard Deviation|Mean
63541|NCT01175213|Secondary|Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.~This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).~In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20||Percentage of participants|||Number
63542|NCT01175213|Secondary|Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.~This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).~In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20||Number of participants|||Number
63543|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||Percentage of infusions|Participants||Number
63544|NCT01175213|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||Percentage of infusions|Participants||Number
63545|NCT01175213|Secondary|The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs|"Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs).~Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20)."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set||SAEs/year|||Number
63546|NCT01175213|Primary|Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency|"Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals).~Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) [or IV infusions of IGSC, 10% only] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals).~After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG.~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set||g/L||95% Confidence Interval|Median
63547|NCT01175213|Primary|Annual Rate of All Infections|"Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) infections and infestations.~The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20||Number of infections/year||95% Confidence Interval|Number
63548|NCT01175213|Primary|Annual Rate of Serious Bacterial Infections|"The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20||Estimated infections/year|||Number
63549|NCT01175031|Secondary|Device-Detected Clear Airway Apnea Agreement|Device Detected Clear Airways were broken down and then reviewed with the manually scored apneas. Of the clear airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored, hypopneas and manually scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|335 Device Detected Clear Airway Apneas were detected.||events|Participants||Number
63550|NCT01175031|Secondary|Device-Detected Obstructed Airway Apnea Agreement|Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|762 Device Detected Apneas were detected.||events|Participants||Number
63553|NCT01175018|Secondary|Number of Adverse Events Requiring Withdrawal in Each Group||10-14 weeks|||adverse events|||Number
63567|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.||mL/m2||Inter-Quartile Range|Median
63568|NCT01175018|Primary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices|Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.|10-14 weeks minus baseline|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.||mL/m2||Inter-Quartile Range|Median
63569|NCT01175005|Primary|Procalcitonin Level at ED Presentation|Level of procalcitonin will be obtained. At the end of the study we will determine who was septic or bacteremic and compare the procalcitonin levels between those who were septic/bacteremic and those who were not.We will attempt to identify whether a level of procalcitonin exists above which rates of bacteremia or bacterial sepsis in patients with fever and a central line exist. Blood cultures will be followed for up to 5 days until reported as final.There are no further study interventions.|Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.|||ng/dL||95% Confidence Interval|Mean
63570|NCT01174784|Primary|CTO Crossing Success Using the Wildcat|Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.||participants|||Number
63571|NCT01174784|Primary|Major Adverse Events|The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.||participants|||Number
63572|NCT01174576|Primary|Total Energy Intake|the energy consumed at breakfast, ad libitum meal and rest of the experimental day|1 d|||kcal||Standard Deviation|Mean
63573|NCT01174576|Primary|Energy ad Libitum Meal|The energy of first meal 3 hr after ingestion|3 hr post ingestion|||kcal||Standard Deviation|Mean
63574|NCT01174576|Primary|Cortisol Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||ug*h/dL||Standard Deviation|Mean
63575|NCT01174576|Primary|Insulin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||uU*h/ml||Standard Deviation|Mean
63576|NCT01174576|Secondary|Serum Antioxidant Capacity Total Area Under the Curve|"Serum samples, collected 15 min before ingestion, immediately after ingestion, 15 min, 30 min, 60 min, 90 min, 120 min and 150 min after ingestion were analyzed for the ex vivo serum resistance to oxidative stress, that was induced by copper sulfate (CuSO4). The analysis of all collected samples was performed by the measurement of conjugated diene formation, which was monitored for every sample of all time points every 2 min for a 3.5 h period at 234 nm in a microplate spectrophotometer.~Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150 min postconsumption."|15 min before ingestion to 21/2 hr post ingestion|||lag time (min) *h||Standard Deviation|Mean
63577|NCT01174576|Primary|Glucose Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||mg*h/dl||Standard Deviation|Mean
63578|NCT01174576|Primary|Interleukin-18 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||pg*h/mL||Standard Deviation|Mean
63579|NCT01174576|Primary|Inteleukin-6 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||pg*h/mL||Standard Deviation|Mean
63580|NCT01174576|Primary|Adiponectin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 h post ingestion|||ug*h/mL||Standard Deviation|Mean
63581|NCT01174576|Primary|Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||ug*h/mL||Standard Deviation|Mean
63582|NCT01174576|Primary|Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||pg*h/mL||Standard Deviation|Mean
63583|NCT01174576|Primary|Ghrelin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion|||ug*h/mL||Standard Deviation|Mean
63584|NCT01174550|Secondary|Cumulative Radiation Exposure Within 90 Days|Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.|90 days|||milliSievert (mSv)||Inter-Quartile Range|Median
63585|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing|Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing|6 month, 12 month 24 month|The number of participants were limited due to budget constraints.||% of participants|||Number
63586|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 months, 12 months, 24 months|The number of participants were limited due to budget constraints.||participant score||Inter-Quartile Range|Median
63587|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 month, 12 month, 24 month|The number of participants were limited due to budget constraints.||participant score||Inter-Quartile Range|Median
63588|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Duke Activity Status Index|Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline, 6 months, 12 months 24 months|The number of participants were limited due to budget constraints.||participant score||Inter-Quartile Range|Median
63589|NCT01174550|Secondary|Medical Cost|Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.|90 days and 3 years cumulative|Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.||Per participant cost in US dollars||95% Confidence Interval|Mean
63590|NCT01174550|Secondary|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization|Up to 90 days following participant randomization|||Percentage of events||Standard Error|Mean
63591|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
63592|NCT01174550|Secondary|Time to Major Complications From Cardiovascular (CV) Procedures|Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
63593|NCT01174550|Secondary|Time to Death or Myocardial Infarction (MI)|Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
63594|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization|Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
63595|NCT01174550|Primary|Time to Primary Endpoint|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months|||Percentage of participants with an event|||Number
63596|NCT01174459|Secondary|Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)|International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.|after 12 months or at the end of observation|Efficacy set: The patient set included all patients in the safety set with approved indication RLS and had IRLS total score measurement at baseline and at least one post-baseline time point.||Score on a scale||Standard Error|Mean
63597|NCT01174459|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 Months|Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.||participants|||Number
63598|NCT01174446|Secondary|Health Resource Use - Days Lost From Work or School||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Days||Full Range|Median
63599|NCT01174446|Secondary|Health Resource Use - Unscheduled Doctor's Office Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Visits||Full Range|Median
63600|NCT01174446|Secondary|Health Resource Use - Emergency Room Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Visits||Full Range|Median
63601|NCT01174446|Secondary|Health Resource Use - Total Days of Hospital Stay||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Days||Full Range|Median
63602|NCT01174446|Secondary|Health Resource Use - Number of Hospitalizations||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Hospitalizations||Full Range|Median
63603|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haemo-QoL - Participants On-Demand (Ages 12-16)|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63604|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haem-A-QoL|The Haem-A-QOL instrument has been developed and used in hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: physical health, sports/leisure, school/work, dealing with hemophilia, and outlook for the future. For the Haem-A-QOL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63605|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Total Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63606|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Psychosocial Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63607|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Physical Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63608|NCT01174446|Secondary|SF-36: HRQoL General Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63609|NCT01174446|Secondary|SF-36: HRQoL Social Functioning|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63610|NCT01174446|Secondary|SF-36: HRQoL Vitality|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63611|NCT01174446|Secondary|SF-36: HRQoL Mental Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63612|NCT01174446|Secondary|SF-36: HRQoL Bodily Pain|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63613|NCT01174446|Secondary|SF-36: HRQoL Role-Emotional|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63614|NCT01174446|Secondary|SF-36: HRQoL Role-Physical (RP)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63615|NCT01174446|Secondary|SF-36: HRQoL Physical Functioning' (PF)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63616|NCT01174446|Secondary|SF-36: HRQoL 'Mental Health' (MH)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63617|NCT01174446|Secondary|Short Form (36) Health Survey (SF-36): HRQoL 'Physical Component Score' (PCS)|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63618|NCT01174446|Secondary|General Pain Assessment Through a Visual Analog Scale (VAS)|Participant rated assessment of health-related quality of life. The VAS Pain Scale rates current health state on a scale from 0 (no pain) to 100 (worst imaginable pain). For the pain scale, a higher score indicates worse pain.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63619|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions Visual Analogue Scale (EQ-5D VAS) Scores|Participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better quality of life.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63620|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Total Index Scores|EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set||Score on a scale||Standard Deviation|Mean
63621|NCT01174446|Secondary|Number of Participants With Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)|||participants|||Number
63622|NCT01174446|Secondary|Number of Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||adverse events|||Number
63623|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Thrombogenic Markers|Clinically significant changes in thrombogenic markers assessments for thrombin-antithrombin (TAT), prothrombin fragment 1.2, and D-dimer as evaluated by an independent Data Monitoring Committee (DMC)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63624|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Vital Signs|Clinically significant changes in vital signs assessments for pulse rate, systolic/diastolic blood pressure, respiratory rate, body temperature|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
87630|NCT00932126|Secondary|Baseline Tumor Expression of PAK-related Pathway Molecules and Other Known Biomarkers||Baseline|Data not analyzed due to early study termination.|||||
63625|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Hematology|Clinically significant changes in hematology assessments for Basophils, Basophils/Leukocytes, Eosinophils, Eosinophils/Leukocytes, Erythrocyte Mean Corpuscular Hemoglobin Concentration, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Lymphocytes/Leukocytes, Monocytes, Monocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes, Platelets,|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63626|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Clinical Chemistry|"Clinically significant changes in chemistry assessments for Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bicarbonate, Bilirubin, Blood Urea Nitrogen, Chloride, Glucose, Potassium, Protein (Serum), Sodium.~Clinically Significant (CS) defined as:~1. The abnormal value constitutes an adverse event (AE) and,~2. The abnormal value is a symptom of or related to a disease that is already recorded as an AE in Case Report Form (CRF)."|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63627|NCT01174446|Secondary|Number of Participants Who Experienced Thrombotic Events||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63628|NCT01174446|Secondary|Number of Participants Who Experienced Severe Allergic Reactions (e.g. Anaphylaxis)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63629|NCT01174446|Secondary|Occurrence of Treatment Related Total Binding Antibodies|Occurrence of treatment related total binding antibodies to Factor IX (FIX), antibodies to Chinese hamster ovary (CHO) proteins, and recombinant furin (rFurin) is defined by more than 2-dilution increase as compared to levels at screening visit and confirmed specificity (e.g. negative to 1:80)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63630|NCT01174446|Secondary|Occurrence of Total Binding Antibodies of Indeterminate Specificity (Within Assay Variability)|Occurrence of total binding antibodies of indeterminate specificity (within assay variability) to FIX, antibodies to CHO proteins and rFurin is defined by a dilution of 2 or less increase as compared to levels at screening visit (e.g. negative to 1:20 or 1:40).|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63631|NCT01174446|Secondary|Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||participants|||Number
63632|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Weight-adjusted Consumption Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||IU/kg||Inter-Quartile Range|Median
63633|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Number of Infusions Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set||Infusions||Inter-Quartile Range|Median
63634|NCT01174446|Secondary|Consumption of BAX326 Per Event Per Participant|Weight-adjusted consumption of BAX326 by event per participant, i.e., for prophylactic treatment and for treatment of bleeds until resolution of bleed.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set||IU/kg||Inter-Quartile Range|Median
63635|NCT01174446|Secondary|Total Weight-adjusted Dose Per Bleeding Episode (BEs) of All BEs Treated With BAX326 by Bleeding Site and Cause||Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set||IU/kg|Participants|Inter-Quartile Range|Median
63636|NCT01174446|Secondary|Hemostatic Efficacy at Resolution of All Bleeding Episodes (BEs) Treated With BAX326 by Bleeding Site and Cause|"Rating Scale for Treatment of BEs (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|At bleed resolution throughout the study period of 22 months (Study Parts 1, 2, and 3)|Full Analysis Set||Bleeding episodes|Participants||Number
63637|NCT01174446|Secondary|Bleeding Episodes Treated With 1, 2 or ≥3 Infusions of BAX326 by Bleeding Site and Cause|The number of bleeding episodes treated with 1, 2, or ≥3 infusions of BAX326 to achieve adequate hemostasis. Only infusions required until resolution of bleed were considered.|Study Part 2 = 26 weeks ± 1 week (Study Part 2 began at week 3-5)|Full Analysis Set||Bleeding episodes|Participants||Number
63638|NCT01174446|Secondary|Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326|ABR during prophylaxis (twice-weekly) in Part 2 was calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25. The treatment period on prophylaxis was defined as time between the first and the last prophylactic infusions and ABR on prophylaxis was calculated for participants who received a minimum of 3 months of prophylactic treatment with BAX326.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set - Prophylactic cohort||Bleeds per year||Inter-Quartile Range|Median
63639|NCT01174446|Secondary|Study Parts 1 and 3: Volume of Distribution at Steady State (Vss)|"Vss computed as CL·MRT.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||dL/kg||Inter-Quartile Range|Median
63743|NCT01173055|Primary|Pain Threshold at Baseline|The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm^2.|Week 0|||kg/cm^2||Standard Deviation|Mean
63640|NCT01174446|Secondary|Study Parts 1 and 3: Half Life (T 1/2)|"Elimination phase half-life will be determined as ln2/ λz.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||Hour||Inter-Quartile Range|Median
63641|NCT01174446|Secondary|Change in Incremental Recovery (IR) at 30 Minutes Over Time|The median changes in IR at 30 Minutes, calculated as the change in IR value from exposure day 1 (ED1).|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
63642|NCT01174446|Secondary|Incremental Recovery (IR) at 30 Minutes Over Time|"IR at 30 Minutes was measured at the following time points during the study:~Part 1 or Part 2, Exposure Day (ED) 1. (If participant was present for Study Part 1, then ED 1 from Part 1 was used. If Participant entered study in Study Part 2, then ED 1 from Part 2 was used.)~Part 2: Week 5~Part 2: Week 13~Part 2 or Part 3: Week 26 (Week 26 of study participation)~Study Completion or Termination Visit"|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
63643|NCT01174446|Secondary|Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax)|"Defined as (Cmax - Cpre-infusion)/Dose, where maximum concentration (Cmax) will be determined as the highest concentration achieved within one hour after infusion.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 1 hour post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
63644|NCT01174446|Secondary|Study Parts 1 and 3: Clearance (CL)|"Computed as Dose/ AUC0-∞.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||dL/(kg·hr)||Inter-Quartile Range|Median
63645|NCT01174446|Secondary|Study Parts 1 and 3: Mean Residence Time (MRT)|"Computed as Area under the moment curve 0-∞ (AUMC0-∞) / AUC0-∞- TI/2, where AUMC0-∞ will be determined in a similar manner as AUC0-∞ and TI represents infusion duration [hr]~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||Hour||Inter-Quartile Range|Median
63646|NCT01174446|Secondary|Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose)|"Defined as (AUC0-t + Ct)/ λz/ dose, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration. λz will be estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU·hr)/ dL/ (IU/kg)||Inter-Quartile Range|Median
63647|NCT01174446|Primary|Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose|Computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.|72 hours|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"||(IU·hr/dL) / (IU/kg)||Inter-Quartile Range|Median
63648|NCT01174342|Primary|Intraocular Pressure|Intraocular pressure during different stages of child delivery.|During child delivery|We included in the analysis all women completing vaginal delivery that had measurements of their intraocular pressure during most stages of labor.||mm Hg||Standard Deviation|Mean
63649|NCT01174264|Primary|Tmax Following Steady State Exposure for 14 Days|Time of maximum drug concentration.|24 hours|||hours||Standard Deviation|Mean
63650|NCT01174264|Primary|AUC Following Steady State Exposure for 14 Days|Area under the curve from 0 to 24 hours.|24 hours|3 and 2 patients with missing data, respectively||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
63651|NCT01174264|Primary|Cmax Following Steady State Exposure for 14 Days|Maximum drug concentration over 24 hours.|24 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
63652|NCT01174264|Primary|Ctrough Following Steady State Exposure for 14 Days|Minimum blood concentration over 24-hour observation period. Blood sample collected at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 24 hours.|24 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
63653|NCT01174264|Primary|Tlag Following Single Dose of Drug|Time between drug administration and when it is first observed in the systemic circulation.|168 hours|||hours||Standard Deviation|Mean
63654|NCT01174264|Primary|Tmax`Following Single Dose of Drug|Time of maximum drug concentration|168 hours|||hours||Standard Deviation|Mean
87704|NCT00931463|Primary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization||48 weeks following randomization|modified intention-to-treat||participants|||Number
63655|NCT01174264|Secondary|Objective Responses in Patients With Solid Tumors|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 30 days|2 patients in Arm I and 4 patients in Arm III were non-evaluable for response.||participants|||Number
63656|NCT01174264|Primary|AUC Following Single Dose of Drug|Area under the curve from 0-168 hours.|168 hours|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
63657|NCT01174264|Primary|Cmax Following Single Dose of Drug|Highest observed concentration over the 168 hour period. Blood samples were collected at j0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 24, 48, 120, and 168 hours.|168 hours|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
63658|NCT01174186|Secondary|Assessment Group in Ankylosing Spondylitis (ASAS) Core Set for Clinical Practice|clinical measurements of inflammation in spondyloarthritis patients as described by the Assessment Group in Ankylosing Spondylitis (ASAS)|one year||||||
63659|NCT01174186|Secondary|Spondyloarthritis Consortium of Canada Score|Inflammation on MRI assessed by the Spondyloarthritis Consortium of Canada score and a Danish scoring method|one year||||||
63660|NCT01174186|Primary|Change in Intestinal Inflammation Measured by Faecal Calprotectin|"Feacal calprotectin is a protein and a marker of the degree of inflammation in the intestine, but not the site of inflammation.~We measured the level calprotectin continuously in each of the patients. Difference was inferred by repeated measurement ANOVA"|Baseline to 52 weeks|"15 patients in each group was included. 3 in the calprotectin negative group patients did not fulfill the entire study period (1 lost to follow-up, 2 withdrew consent).~Data analysed as last observation carried forward."||mg/g||Inter-Quartile Range|Median
63661|NCT01174186|Primary|Change Lewis Score Index|"Lewis' score describes the amount of inflammation seen optically by capsular endoscopy.~Gralnek et al. devised and validated the Lewis score index, based on three endoscopic parameters: villous edema, ulcer and stenosis/stricture. Using these parameters, the authors established a score range of 8–4,800 points where: LS < 135 reflects normal mucosal appearances, LS 135–790 mild mucosal inflammatory change and an LS value ≥790 moderate to severe mucosal inflammatory changes.~The patients had endoscopy performed at baseline and again after 20 weeks. The number of patients improving was compared to number of patients deteriorating"|20 weeks|Because endoscopy has a small risk for perforation. The study was designed so only patients with active inflammation at baseline had follow-up endoscopy performed. Because all patients with normal calprotectin levels had normal endoscopy, follow-up was only performed on this group of patients.||units on a scale||Inter-Quartile Range|Median
63662|NCT01174173|Secondary|Right Ventricular Hemodynamics|Mean pulmonary artery pressure was assessed invasively by right heart catheterization at the conclusion of the study to estimate right ventricular hemodynamics.|3 months|Analysis was performed on all participants who completed right heart catheterization at the conclusion of the study||mm Hg||Standard Deviation|Mean
63663|NCT01174173|Secondary|Absolute RV Longitudinal Strain|Change in absolute right ventricular (RV) longitudinal strain as assessed by exercise stress echocardiography with speckle-tracking echocardiography at baseline and conclusion of the study. An increase in exercise-induced change in RV longitudinal strain between baseline to conclusion of the study is indicative of improved RV function. If absolute RV longitudinal strain increases with exercise, that is a sign that the RV is working well. If absolute RV longitudinal strain decreases with exercise, that is a sign that the RV is not working well. Therefore, between baseline and conclusion of the study, if exercise-induced change in RV strain increases that means that the RV is working better at the conclusion of the study.|3 months|Analysis was performed on all participants who completed exercise stress echocardiography at baseline and conclusion of the study (month 3)||percentage||Standard Deviation|Mean
63664|NCT01174173|Secondary|RV Perfusion on Cardiac MRI|The majority of patients did not undergo cardiac MRI because it was difficult for the patients to tolerate the imaging study. Therefore, we were not able to assess change in RV perfusion.|3 months||||||
63665|NCT01174173|Primary|Improve Quality of Life|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The scores are averaged and transformed to a range of 0-100, in which higher scores reflect better health status and was performed at the conclusion of the study.|3 Months|Analysis was performed on the 8 participants who completed the KCCQ questionnaire at baseline and at the conclusion of the study (month 3)||KCCQ Summary Score||Standard Deviation|Mean
63666|NCT01174173|Primary|6-Minute Walk Test|Improve Exercise Capacity measured by 6-Minute Walk Test|3 Months|Analysis was performed in all participants who completed the study and had a 6-minute walk test at baseline and at the conclusion of the study.||meters||Standard Deviation|Mean
63667|NCT01174173|Primary|Improve Angina Symptoms|Assessed as average improvement in WHO Functional Class. The WHO Functional Class score ranges from 1 to 4, with higher scores indicating more impairment|3 months|Analysis was performed on all participants who completed as average change in WHO Functional class score from baseline to 3 months (Baseline, 3 months)||units on a scale||Standard Deviation|Mean
63668|NCT01174160|Primary|Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm|The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute|Within 90 minutes after first exposure|||participants|||Number
63669|NCT01174043|Other Pre-specified|Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts||Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12||||||
63670|NCT01174043|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater.|up to 15 months|||participants|||Number
64036|NCT01170598|Primary|6-minute Walk Test|Measure of functional endurance assessed by the walking distance covered in a 6-minute period. Participants walk a pre-established course for a total of 6 minutes. The distance covered in that time is recorded as the 6-minute walk test score.|Baseline, Post-induction (4-6 weeks)|||feet||Standard Deviation|Mean
63671|NCT01174043|Secondary|Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission|The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells.|1 year after treatment discontinuation|All patients enrolled and received treatment||months||Standard Deviation|Mean
63672|NCT01174043|Primary|Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib|The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated.|3 months of treatment with erlotinib|All patients enrolled and received treatment||percentage of participants||95% Confidence Interval|Number
63673|NCT01174030|Secondary|PSA-5 Success|"Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.~PSA-5 success defined as 2-grade improvement on PSA-5.~Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness~/ Very mild redness~/ Mild redness~/ Moderate redness~/ Severe redness"|day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.||participants|||Number
63674|NCT01174030|Secondary|CEA Success|"CEA success defined as 2-grade improvement on CEA.~Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.~Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema~/ Amost clear; slight redness~/ Mild erythema; definite redness~/ Moderate erythema; marked redness~/ Severe erythema; fiery redness"|Day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.||participants|||Number
63675|NCT01174030|Primary|Composite Success|"Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).~Each concentration/regimen was compared to its respective placebo control as part of the primary analysis."|Day 29|Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.||participants|||Number
63676|NCT01174004|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Study Days 1 and 43|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date.||Score on the UPDRS-II+III||95% Confidence Interval|Least Squares Mean
63677|NCT01174004|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson’s Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.~Analysis Method: Mixed Model Repeated Measures (MMRM)"|Each study visit (i.e. Days 1, 15, 29 and 43)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date."||Score on the SAPS-PD scale||95% Confidence Interval|Least Squares Mean
63678|NCT01173718|Secondary|Time to Potential Central Venous Catheter Removal|The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.|Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123|All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations||days||Full Range|Median
63679|NCT01173718|Secondary|Time to First Cannulation|The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.|Time of access placement to first cannulation, assessed up to one week|All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations||percentage of grafts|||Number
63680|NCT01173718|Secondary|Time to Event Analysis (Cumulative Patency)|The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.|6 Months|All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations||percentage of participants||95% Confidence Interval|Number
63681|NCT01173718|Secondary|Primary Unassisted Patency at 6 Months|The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.|6 Months|All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations||percentage of participants|||Number
63682|NCT01173718|Primary|Freedom From Bleeding at 6 Months|Percentage of subjects free from both major and minor bleeding events, assessed at 6-months|6 Months|All subjects with unknown bleeding status at the 6 month window were omitted from calculations||percentage of participants||95% Confidence Interval|Number
63683|NCT01173718|Primary|Cumulative Patency at 6 Months|Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.|6 Months|All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations||percentage of participants||95% Confidence Interval|Number
88084|NCT00928395|Secondary|GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.||every three months for 36 months||||||
63684|NCT01173653|Primary|Smoking Status at Follow up|Patients enrolled in this study were contacted via phone to assess smoking status. Smoking status was a self-report from each subject. Primary outcome measure is the smoking status of the enrollee at the time of follow-up contact. We calculated the percentage of participants who had stopped smoking at the 6 week follow-up period in each arm|6 weeks|Of subjects enrolled, 56 of the 109 subjects in the control arm and 49 of 90 subjects in the intervention arm were able to be contacted via phone and were willing to provide follow-up data for analysis of smoking status at the 6 week follow-up.||percentage of participants|||Number
63685|NCT01173471|Secondary|Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set||mmHg||95% Confidence Interval|Least Squares Mean
63686|NCT01173471|Secondary|Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment||Baseline to 4 weeks|Efficacy analysis set||Participants|||Number
63687|NCT01173471|Primary|Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set||Percentage change||95% Confidence Interval|Least Squares Mean
63688|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.||participants|||Number
63689|NCT01173211|Secondary|HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.||Titers||95% Confidence Interval|Mean
63690|NCT01173211|Secondary|Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.||participants|||Number
63691|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Blood was collected from all participants prior to vaccination as well as at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the titer was 40 or greater at delivery, or the Day 0 titer was greater than or equal to 10 and the titer was an increase by 4-fold or more at delivery.|Day 0 prior to vaccination and at time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.||participants|||Number
63692|NCT01173211|Primary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 0 prior to and Day 28 after vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.||participants|||Number
63693|NCT01173211|Primary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 28 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 28 after vaccination|||participants|||Number
63694|NCT01173211|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 following vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.||Titers||95% Confidence Interval|Geometric Mean
63695|NCT01173211|Secondary|Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.||Titers||95% Confidence Interval|Geometric Mean
63696|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.||participants|||Number
63697|NCT01173211|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
63698|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
63699|NCT01173211|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
63700|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 180 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 180 post vaccination titer was an increase by 4-fold or more.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.||participants|||Number
63701|NCT01173211|Secondary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected for HAI assay at approximately Day 180 following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.||Titer||95% Confidence Interval|Geometric Mean
63702|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.||participants|||Number
63703|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving vaccination are included in the safety cohort||participants|||Number
63704|NCT01173211|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.||participants|||Number
63705|NCT01173211|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|During the pregnancy and at the time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.||participants|||Number
63706|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination|All participants receiving vaccination are included in the safety cohort||participants|||Number
63716|NCT01173120|Primary|Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy|BL=baseline; LLN lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes: <0.75*BL; Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/ >1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/ >7.50*10^3 c/uL.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
63707|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly immunoglobulin (Ig) category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNCT)category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing. TRT=treatment|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.||participants|||Number
63708|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.||participants|||Number
63709|NCT01173120|Primary|Mean Temperature Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||degrees Celsius||Standard Deviation|Mean
63710|NCT01173120|Primary|Mean Heart Rate Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||beats per minute||Standard Deviation|Mean
63711|NCT01173120|Primary|Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||mm Hg||Standard Deviation|Mean
63712|NCT01173120|Primary|Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||mm Hg||Standard Deviation|Mean
63713|NCT01173120|Primary|Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
63714|NCT01173120|Primary|Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
63715|NCT01173120|Primary|Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
63717|NCT01173120|Primary|Number of Participants With AEs of Special Interest in the ACP Device Substudy|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs including all infections, local injection reactions (prespecified), and systemic injection reactions (within 24 hours of dosing).|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of subcutaneous abatacept administered via the ACP.||participants|||Number
63718|NCT01173120|Secondary|Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy|Trough levels of abatacept were evaluated based upon serum samples. Day 1 pharmacokinetics were based on exposure to the pre-filled syringes and did not reflect abatacept exposure via the ACP device.|Days 1, 29, 57, 85, 169, and 253 of ACP substudy|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP. Trough concentrations in participants who discontinued from the substudy were not summarized descriptively, but were included in the concentration listings.||ug/mL||Standard Deviation|Geometric Mean
63719|NCT01173120|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.||participants|||Number
63720|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to Week 15 of Treatment.||Week 15||||||
63721|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to Week 9 of Treatment.||Week 9||||||
63722|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to Week 6 of Treatment.||Week 6||||||
63723|NCT01173055|Secondary|Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment.||Week 0||||||
63724|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to Week 15 of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 15||||||
63725|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to Week 9 of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 9||||||
63726|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to Week 6 of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 6||||||
63727|NCT01173055|Secondary|Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Week 0 - Week 15||||||
63728|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to Week 15 of Treatment||Week 15||||||
63729|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to Week 9 of Treatment||Week 9||||||
63730|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to Week 6 of Treatment||Week 6||||||
63731|NCT01173055|Secondary|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment||Week 0 to Week 15||||||
63732|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to End of Treatment|The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|Week 0 -Week 15|||kg/cm^2||Standard Deviation|Mean
63733|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to Week 9 of Treatment||Week 9||||||
63734|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to Week 6 of Treatment||Week 6||||||
63735|NCT01173055|Secondary|Pain Tolerance at Baseline|The primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline.|Week 0|||kg/cm^2||Standard Deviation|Mean
63736|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|Week 0 - Week 15|On participant did not complete this outcome measure.||units on a scale||Standard Deviation|Mean
63737|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to Week 9 of Treatment.||Week 9||||||
63738|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to Week 6 of Treatment.||Week 6||||||
63739|NCT01173055|Secondary|Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|Week 0|One participant did not complete this outcome measure.||units on a scale||Standard Deviation|Mean
63740|NCT01173055|Primary|Change in Pain Threshold From Baseline to End of Treatment.|The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|Week 0 - Week 15|||kg/cm^2||Standard Deviation|Mean
63741|NCT01173055|Primary|Change in Pain Threshold From Baseline to Week 9 of Treatment|The primary outcome parameter is the change in medium pressure pain threshold from baseline to end of treatment.|Week 9||||||
63742|NCT01173055|Primary|Change in Pain Threshold From Baseline to Week 6 of Treatment.|The primary outcome parameter is the change in medium pressure pain threshold from baseline to week 6 of treatment.|Week 6||||||
63744|NCT01173029|Post-Hoc|Polygenic Risk Score|"Among all analyzed, four renin-angiotensin-aldosterone polymorphisms had statistical significance relating to composite endpoint.~They were: Angiotensinogen, renin, angiotensin II type 1 receptor and aldosterone synthase. Each polymorphism was arbitrarily weighted according to respective presentation in both alleles as follows: zero (low risk homozygosis), one (heterozygosis) and two (high risk homozygosis). In a following step, they were summed up for each subject, thus, creating a polygenic risk score.~The weights of the polymorphisms were, thus, defined:~Angiotensinogen: MM - zero, MT - one, TT - two~Renin: AA - zero, GA - one, GG - two~Angiotensin II type 1 receptor: CC - zero, AC - one, AA - two~Aldosterone synthase: CC - zero, TC - one, TT - two~The polygenic risk score value ranges from zero (all low risk polymorphisms in homozygosis) to eight (all high risk polymorphisms in homozygosis)."|up to 10 years|Subjects in both resistant systemic arterial hypertension and pseudo-resistant systemic arterial hypertension groups had their respective genetic background scored according to present rule.||composite enpoint events|||Number
63745|NCT01173029|Secondary|Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.~Evidence of clinically definite acute myocardial infarction (prolonged > 20min chest pain, not relieved by sublingual nitrate, ST-T segment deviation on 12-lead surface ECG, elevation of plasma troponin >0.2 ng/dL 6h following chest pain episode).~Death was considered to be related to the event if occurring up to 30 days after the acute event.~Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.~A post-hoc sampling procedure (power calculation) validated sample size."||participants|||Number
63746|NCT01173029|Primary|Strokes, Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.~Death was considered to be related to the event if occurring up to 30 days after the acute event.~Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.~A post-hoc sampling procedure (power calculation) validated sample size."||participants|||Number
63747|NCT01172938|Secondary|Number of Participants With Adverse Events||Up to 5 years||10/2017||||
63748|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
63749|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
63750|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
63751|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
64055|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.|Day 11|The ITT analysis set includes data from all randomized participants.||participants|||Number
63752|NCT01172938|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants|||Number
63753|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
63754|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
63755|NCT01172938|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
63756|NCT01172938|Secondary|Change From Baseline in the DAS28 at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
63757|NCT01172938|Secondary|Change From Baseline in the CDAI Score at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
63758|NCT01172938|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
63759|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
64056|NCT01170221|Primary|Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|48-72 hours|The ITT analysis set includes data from all randomized participants.||Responders|||Number
64057|NCT01170208|Secondary|Incidence of Severe or Serious Hypoglycemia.||January 2011||||||
63760|NCT01172938|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||mm||Standard Deviation|Mean
63761|NCT01172938|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS.~Two-sided 95% confidence interval is based on the Clopper-Pearson method."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
63762|NCT01172938|Secondary|Change From Baseline in the SF-36 Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
63763|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.||units on a scale||Standard Deviation|Mean
63764|NCT01172938|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.||percentage of participants||95% Confidence Interval|Number
63765|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63766|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63819|NCT01172821|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
64058|NCT01170208|Secondary|Reduction in Fructosamine.||January 2011||||||
63767|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63768|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63769|NCT01172938|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63770|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63771|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63772|NCT01172938|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63773|NCT01172938|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63820|NCT01172821|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points.The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS||Percentage of participants|||Number
64059|NCT01170208|Secondary|Reduction in HbA1c.||January 2011||||||
63774|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63775|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63776|NCT01172938|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63777|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63778|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63779|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
63780|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
63821|NCT01172821|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items and ranges from from 0 (no symptoms) till 6 (highest intensity). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||units on a scale||Standard Error|Mean
63781|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
63782|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
63783|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
63784|NCT01172938|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||mm||Standard Error|Least Squares Mean
63785|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63786|NCT01172938|Secondary|Change From Baseline in SF-36 Physical Function at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
63787|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
63788|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
63789|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
63790|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.||units on a scale||Standard Error|Least Squares Mean
63791|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
63792|NCT01172938|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||mm||Standard Error|Least Squares Mean
63793|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63794|NCT01172938|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.||units on a scale||Standard Error|Least Squares Mean
63795|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.||units on a scale||Standard Error|Least Squares Mean
63796|NCT01172938|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response at Week 24. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.||percentage of participants|||Number
63797|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
63798|NCT01172938|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.||percentage of participants|||Number
63799|NCT01172873|Secondary|Beck Depression Inventory (BDI)|Beck’s Depression Inventory (BDI): This is a 21-item self report that measures depression symptoms and will be used for both adults and adolescents at baseline, session 5, session 10 and the follow-up visit. BDI-II scores range from 0-63, with higher scores representing greater severity of depression symptoms.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures. Another was excluded because she was unable to provide reliable data on outcome measures.||units on a scale||Standard Deviation|Mean
63800|NCT01172873|Secondary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC): This is a 39-item self-report that measures anxiety symptoms. It provides a total score, as well as 10 subscales, although only total scores will be analyzed. MASC scores range from 0-117, with higher scores representing greater severity of anxiety symptoms. The MASC and will be administered at baseline, session 5, session 10 and the follow-up visit for adolescents.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.||units on a scale||Standard Deviation|Mean
63801|NCT01172873|Primary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents|The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.||units on a scale||Standard Deviation|Mean
63802|NCT01172847|Secondary|Number of Participants With Clinically Significant or Treatment Related Changes in Electrocardiogram (ECG)|ECG was recorded when participants were rested in a supine position for at least 5 minutes.|Screening; pre-dose on Day 1 and Day 5 of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
63803|NCT01172847|Secondary|Number of Participants With Marked Abnormality in Laboratory Parameters|"Laboratory analysis included hematology (hemoglobin, hematocrit, erythrocytes, platelets counts, leukocytes counts, neutrophils, eosinophils, lymphocytes, basophils, and monocytes);, biochemistry (aspartate aminotransferase , alanine aminotransferase, gamma glutamyl trans peptidase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, albumin, creatinine, urea, creatine phosphokinase, total protein, sodium, chloride, calcium, phosphate, potassium, glucose (fasting), amylase, lipase, total cholesterol, and calculated creatinine clearance); and urinalysis.~Marked laboratory test values (high and low) falling outside the marked reference range and which also represents a clinically relevant change from baseline of at least a designated amount were recoded. In this study, marked abnormality ranges for phosphate as 0.75 – 1.60 millimole (mmol)/L and proteinuria (0 to 4+, and 1)."|Screening; Day -1 and Day 5 (pre-dose) of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
63804|NCT01172847|Secondary|Number of Participants With Abnormal Vital Signs|Vital signs included heart rate (HR), blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), and body temperature. Blood pressure and pulse rate were recorded when participants were rested in a supine position for at least 5 minutes and after standing for 2 minutes. Vital signs values that fall outside the investigator’s normal ranges were recorded.|Screening (Days -28 to -2); pre-dose and 2h post-dose on D1 and D5 of each treatment period; at Follow-up visit (10 -14 days after last dose) for blood pressure and HR; Screening; Day -1 of each treatment period; Follow-up visit for temperature|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
64060|NCT01170208|Secondary|Clinical Evaluation of ―Over-ride‖ to Determine if the Reason for ―Over-ride‖ Will Affect a Change in the Algorithm.||January 2011||||||
63805|NCT01172847|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 11 weeks|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.||participants|||Number
63806|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Rimantadine|Cmax of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.||ng/mL||90% Confidence Interval|Least Squares Mean
63807|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. Cmax of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.||ng/mL||90% Confidence Interval|Least Squares Mean
63808|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine|AUC0-12 of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetic analysis population included all participants who were adhered to the protocol.||h*ng/mL||90% Confidence Interval|Least Squares Mean
63809|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetics (PK) analysis population included all participants who were adhered to the protocol.||hours (h)*nanogram (ng)/milliliter (mL)||90% Confidence Interval|Least Squares Mean
63810|NCT01172821|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)||weeks||95% Confidence Interval|Median
63811|NCT01172821|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)||weeks||95% Confidence Interval|Median
63812|NCT01172821|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).||Percentage of participants|||Number
63813|NCT01172821|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS||Days||Standard Error|Mean
63814|NCT01172821|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Number of Puffs||Standard Error|Mean
63815|NCT01172821|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
63816|NCT01172821|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
63817|NCT01172821|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS||Percentage of Mean PEF||Standard Error|Mean
63818|NCT01172821|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
63822|NCT01172821|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|"Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment.~The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items and ranges from from 1 (highest intensity) till 7 (no symptoms). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week."|24 weeks|FAS||units on a scale||Standard Error|Mean
63823|NCT01172821|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre/min||Standard Error|Mean
63824|NCT01172821|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
63825|NCT01172821|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
63826|NCT01172821|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
63827|NCT01172821|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
63828|NCT01172821|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
63829|NCT01172821|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement.||Litre||Standard Error|Mean
63830|NCT01172808|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)||weeks||95% Confidence Interval|Median
63831|NCT01172808|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)||weeks||95% Confidence Interval|Median
63832|NCT01172808|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment)."|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)||Percentage of participants|||Number
63833|NCT01172808|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS||Days||Standard Error|Mean
63834|NCT01172808|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Number of Puffs||Standard Error|Mean
63835|NCT01172808|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
63852|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not come for 2nd block. Among patients came for the 2nd block, blood sample was not collected in 9 Entonox patients and 6 Oxygen patients.||pg/ml||Inter-Quartile Range|Median
63836|NCT01172808|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre||Standard Error|Mean
63837|NCT01172808|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS||Percentage of mean PEF||Standard Error|Mean
63838|NCT01172808|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
63839|NCT01172808|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS||Litre/min||Standard Error|Mean
63840|NCT01172808|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points. The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS||Percentage of Participants|||Number
63841|NCT01172808|Secondary|Total Asthma Control Questionnaire (ACQ) Score at the End of the 24-week Treatment Period|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||units on a scale||Standard Error|Mean
63842|NCT01172808|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||units on a scale||Standard Error|Mean
63843|NCT01172808|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre/min||Standard Error|Mean
63844|NCT01172808|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
63845|NCT01172808|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS||Litre||Standard Error|Mean
63846|NCT01172808|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
63847|NCT01172808|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
63848|NCT01172808|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS||Litre||Standard Error|Mean
63849|NCT01172808|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement excluding patients from one centre due to non-compliance with good clinical practice.||Litre||Standard Error|Mean
63850|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|No blood sample was planned to be collected.|||||
63851|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did come for the 3rd block. Among the patients who came for the 3rd block, blood sample was not collected in 5 Entonox patients and 1 Oxygen patient.||pg/ml||Inter-Quartile Range|Median
64061|NCT01170208|Primary|Weekly Mean Blood Glucose||Twelve week period from week 4 to week 16|Per Protocol||mg/dL||Standard Deviation|Mean
63857|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to 3 months follow-up.|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow-up.||absolute percentage||Standard Deviation|Mean
63858|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3rd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 3rd block.|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 3rd block.||absolute percentage||Standard Deviation|Mean
63859|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 2nd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 2nd block.|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.||absolute percentage||Standard Deviation|Mean
63860|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 3rd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 3rd block"|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 patients in the Entonox group and 26 patients in the Oxygen group did not receive the 2nd block treatment||units on a scale||Standard Deviation|Mean
63861|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 2nd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 2nd block."|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 patients in the Entonox group and 11 patients in the Oxygen group did not receive the 2nd block treatment||units on a scale||Standard Deviation|Mean
63862|NCT01172600|Primary|Change in VAS Pain Score From Baseline to 3 Month Follow-up|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to the 3 month follow-up."|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|For 10 patients with missing VAS at 3 month follow up: 5 patients who had 2nd or 3rd epidural block, we assigned the last VAS observation (i.e., from VAS before 2nd or 3rd block to 3 month follow-up); and for 5 patients who only had 1st epidural, we assigned the worst VAS (10) for Entonox patients and the best VAS (0) for Oxygen patients.||units on a scale||Standard Deviation|Mean
63863|NCT01172535|Primary|Proportion of Participants Tolerating LPV/r|Participants were considered to have tolerated medication if they did not stop treatment before the 24 week PK visit for any reason other than completing treatment or death not related to treatment.|Measured at study completion (week 24)|All participants||proportion of participants||95% Confidence Interval|Number
63864|NCT01172535|Primary|Number of Participants Experiencing Adverse Events of Grade 3 or 4|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death|Measured at study visits through end of study (weeks 2, 4, 12, 24)|All participants||participants|||Number
63865|NCT01172535|Secondary|Treatment Efficacy (CD4%)|Having CD4%≥25 at the week 24 visit.|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit||proportion of participants||95% Confidence Interval|Number
63866|NCT01172535|Secondary|Treatment Efficacy (HIV Viral Load)|Having HIV viral load <400 copies/mL at the week 24 visit|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit||proportion of participants||95% Confidence Interval|Number
63867|NCT01172535|Secondary|Adherence|Adherence, defined as proportion of doses taken (note: proportion could be greater than 1.0 for reasons such as tablets having to be taken twice due to first one being spit out or imprecise measurement of liquid doses)|Measured at week 4, week 12, and study completion (week 24)|Participants bringing medication to be measured at the study visit||Proportion of expected doses taken||Inter-Quartile Range|Median
63868|NCT01172535|Primary|Proportion of Participants With an AUC of Less Than 10% of Adults|Proportion of participants with an AUC less that 10% of adults (AUC0-24 <104 mcg*hr/mL)|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants with complete pharmacokinetics data at week 4||proportion of participants||90% Confidence Interval|Number
63869|NCT01172535|Primary|Clearance of Lopinavir/Ritonavir (CL/F)|Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||L/h/kg||90% Confidence Interval|Geometric Mean
63870|NCT01172535|Primary|Minimum Concentration of Lopinavir/Ritonavir (Cmin)|Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||mcg/mL||90% Confidence Interval|Geometric Mean
63871|NCT01172535|Primary|Maximum Concentration of Lopinavir/Ritonavir (Cmax)|Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||mcg/mL||90% Confidence Interval|Geometric Mean
63872|NCT01172535|Primary|Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)|Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4||mcg*hr/mL||90% Confidence Interval|Geometric Mean
63873|NCT01172522|Primary|Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention|Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants.|Baseline, weekly, and end of study +7 days|Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left.||participants|||Number
63874|NCT01172418|Secondary|Patient Survival||at 3 years post-transplant||||||
63875|NCT01172418|Secondary|Patient Survival||at 1 year post-transplant||||||
63876|NCT01172418|Secondary|Graft Survival||at 3 years post-transplant||||||
63877|NCT01172418|Secondary|Graft Survival||at 1 year post-transplant||||||
63878|NCT01172418|Primary|Incidence of Acute Rejection at One Year Post-transplant||at one year post-transplant|||percentage of patients having BPAR|||Number
63879|NCT01172353|Secondary|Dialysis During Hospitalization||During hospitalization|||participants|||Number
63880|NCT01172353|Primary|Contrast-induced Nephropathy|rise in serum creatinine >0,5mg/dl|48 hours|||percentage of contrast nephropaty|||Number
63881|NCT01172288|Secondary|Number of Participants With Adverse Effects|Number of participants with adverse events according to the Pediatric Adverse Events Rating Scale|12 weeks|||participants|||Number
63882|NCT01172288|Secondary|Overall Improvement|Clinical Global Impression - Improvement Scale (CGI-I). The CGI is a 7-point scare that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.|12 weeks|||units on a scale||Standard Deviation|Mean
63883|NCT01172288|Secondary|Improvement in OCD Severity|Childrens' Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). 10-item scale. Each item is rated from 0-4. A sum total is calculated by adding items 1-10. 0-7: Subclinical. 8-15: Mild. 16-23: Moderate. 24-31: Severe. 32-40: Extreme.|12 weeks|||units on a scale||Standard Deviation|Mean
63884|NCT01172288|Secondary|Improvement of Premonitory Urges|"Premonitory Urge for Tics Scale (PUTS). Items are rated on a scale of 1-4 from least to most. A total score is calculated by summing the scores of all items. Nine is the minimum possible score. A score of 12.5-24.5 indicates medium intensity of premonitory urges for tics. A score of 25-30.5 indicates high intensity which may be associated with marked impairment. Scores 31 and above indicate extremely high intensity with probable severe impairment. A score of 36 is the maximum score possible."|12 weeks|||units on a scale||Standard Deviation|Mean
63885|NCT01172288|Primary|Improvement in Tic Severity|"Yale Global Tic Severity Scale is a standard psychiatric measure that rates tics from 0 (no tics) to 100 (most severe tics).~It separately rates motor tics and vocal tics in 5 subscales (number, frequency, intensity, complexity and interference) where the maximum severity score for motor tics is 25 and for vocal tics is 25. Giving us the Total Tic Severity Score maximum of 50.~The additional Impairment Scale rates the degree of disability caused by the tics ranging from 0 (none) to 50 (severe). When these two scores are added we get the Yale Global Tic Severity Scale Score."|12 weeks|||units on a scale||Standard Deviation|Mean
63886|NCT01172184|Secondary|Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period|After discharge from index hospitalization of surgical intervention, heart failure with rehospitalization will be assessed. Heart failure with re-hospitalization was documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needed an augmented decongestive regimen during an in-hospital stay. The correlation between left atrial distensibility and heart failure was analyzed. ROC curve was used to estimate the best cut-off point.|1-2 years|||participants|||Number
63887|NCT01172184|Secondary|Number of Participants With Post-operation Atrial Fibrillation|After operation, patients received continuous EKG monitor during the ICU stay. After transfer to ordinary ward, patients received 2 times of EKG record per day and another EKG would be done if patients felt palpitation and irregular heart beats were found by nursing staffs. The event of atrial fibrillation (Af) was defined as irregular irregular heart beats which was lack of p wave and last for more than 30 seconds. The relationship between left atrial distensibility and post-operative Af was analysed. ROC curve was used to assess the best cutoff value of left atrial distensibility.|baseline and 1 year|||participants|||Number
63888|NCT01172184|Primary|Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization|Since left ventricular filling pressure more than 15 mmHg indicated poor ventricular compliance and more cardiovascular event in many prior reports, the current study used it as the threshold. Otherwise, the correlation between left ventricular filling pressure and left atrial distensibility was assessed. ROC curve was used to estimate the best cut-off point of left atrial distensibility for predicting left ventricular filling pressure more than 15 mmHg.|1 year|Severe mitral regurgitation affects the accuracy of left ventricular filling pressure estimated by tissue Doppler imaging. Therefore, we conducted this study using left atrial parameters to assess left ventricular filling pressure in patients with severe mitral regurgitation.||mmHg||Standard Deviation|Mean
63889|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|after 8 weeks of treatment|||raw score||Standard Deviation|Mean
63890|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|after 8 weeks of treatment|||raw score||Standard Deviation|Mean
64128|NCT01169311|Secondary|Post Operative Pain|Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain|baseline, 30 days post op|||units on a scale||Standard Deviation|Mean
63891|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|after 8 weeks of treatment|||raw score||Standard Deviation|Mean
63892|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|at baseline|||raw score||Standard Deviation|Mean
63893|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|at baseline|||raw score||Standard Deviation|Mean
63894|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|at baseline|||raw score||Standard Deviation|Mean
63895|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|after 8 weeks of treatment|||T-score||Standard Deviation|Mean
63896|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|at baseline|||T-score||Standard Deviation|Mean
63897|NCT01171976|Secondary|EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24|The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= “no problems”, 2=“some problems” and 3=“extreme problems” . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Score on a scale||Standard Deviation|Mean
63898|NCT01171976|Secondary|Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Score on a scale||Standard Deviation|Mean
63899|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline and 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percent Change||Standard Deviation|Mean
63900|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percent Change||Standard Deviation|Mean
63954|NCT01171820|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up|270 day|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||millimeters|Participants|Standard Deviation|Mean
64129|NCT01169311|Secondary|Incidence of Stapler Malfunction or Misfires||about 20 minutes for procedure|||participants|||Number
63901|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline, 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percentage of pateints|||Number
63902|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Percentage of patients|||Number
63903|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
63904|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline and Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
63905|NCT01171976|Secondary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline to Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
63906|NCT01171976|Primary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline to Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.||Letters||Standard Deviation|Mean
63907|NCT01171963|Secondary|Concentrations for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 5 EL.U/mL) for all antibodies assessed (anti-PT, anti-FHA and anti-PRN). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||EL.U/mL||95% Confidence Interval|Geometric Mean
63908|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). A subject seropositive for anti-PT/anti-FHA/anti-PRN antibodies was defined as a subject with an anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
63909|NCT01171963|Secondary|Titers for Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibodies|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seroprotection cut-off (≥ 8 estimated doses 50% [ED50] for anti-poliovirus type 1 [anti-polio 1]/anti-polio 2/anti-polio 3 antibodies. This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||titers||95% Confidence Interval|Geometric Mean
64130|NCT01169311|Secondary|Time to Return to Normal Activity||30 days post op|||Days||Standard Deviation|Mean
63910|NCT01171963|Secondary|Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3.|A subject seroprotected against poliovirus types 1, 2 and 3 was defined as a subject with anti-poliovirus type 1 (anti-polio 1)/anti-polio 2/anti-polio 3 antibody titer greater than or equal to (≥) 8 estimated doses 50% (ED50). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo (cf. population definition below).|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
63911|NCT01171963|Secondary|Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off assay (≥ 0.1 IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||IU/mL||95% Confidence Interval|Geometric Mean
63912|NCT01171963|Secondary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a subject with an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
63913|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.||U/mL||95% Confidence Interval|Geometric Mean
63914|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age.|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||U/mL||95% Confidence Interval|Geometric Mean
63915|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||U/mL||95% Confidence Interval|Geometric Mean
63916|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.||Subjects|||Number
63917|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
63918|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
63927|NCT01171963|Secondary|Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause|Severe GE was defined as an episode of GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
63919|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.||Subjects|||Number
63920|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
63921|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.||Subjects|||Number
63922|NCT01171963|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or result in disability/incapacity. Any = occurrence of an SAE regardless of the intensity grade or relationship to vaccination.|Throughout the entire study period (from Day 0 to Study End at Month 21)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.||Subjects|||Number
63923|NCT01171963|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination.|Within the 31-day (Days 0–30) follow-up periods following any dose of the Rotarix™ vaccine or placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.||Subjects|||Number
63924|NCT01171963|Secondary|Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix™ Vaccine/Placebo|Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods following Dose 2 of the Rotarix™ vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.||Subjects|||Number
63925|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines|Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix™ vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.||Subjects|||Number
63926|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix™ Vaccine/Placebo|Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix™ vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods after any dose of Rotarix™ vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.||Subjects|||Number
63952|NCT01171820|Secondary|In-stent Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percentage of participants|Participants|95% Confidence Interval|Number
63928|NCT01171963|Secondary|Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
63929|NCT01171963|Secondary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
63930|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
63931|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
63932|NCT01171963|Primary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.||Subjects|||Number
63933|NCT01171924|Primary|Number of Participants With Adverse Events|Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.|12-15 months|||participants|||Number
63934|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63935|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63936|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63937|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63938|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63939|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63940|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63941|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63942|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63943|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63953|NCT01171820|Secondary|Distal Late Loss|Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||millimeters|Participants|Standard Deviation|Mean
63944|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63945|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63946|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|365 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63947|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63948|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|0 to 37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.||Percentage of participants||95% Confidence Interval|Number
63949|NCT01171820|Secondary|In-segment Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.~This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percent diameter stenosis|Participants|Standard Deviation|Mean
63950|NCT01171820|Secondary|In-stent Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.~This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percent diameter stenosis|Participants|Standard Deviation|Mean
63951|NCT01171820|Secondary|In-segment Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||Percentage of participants|Participants|95% Confidence Interval|Number
63955|NCT01171820|Secondary|In-segment Late Loss|In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.||millimeters|Participants|Standard Deviation|Mean
63956|NCT01171820|Secondary|Clinical Procedure Success (Per-patient)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.|immediately post-procedure|The sample size for clinical procedure success is based on the number of evaluable patients, for whom data is available to define clinical procedure success.||Percentage of participants||95% Confidence Interval|Number
63957|NCT01171820|Secondary|Clinical Device Success (Per-lesion)|Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.|immediately post-procedure|Analysis based on intention to treat (ITT) population.||Percentage of lesions|Participants|95% Confidence Interval|Number
63958|NCT01171820|Primary|In-stent Late Loss (LL)|In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up.||millimeters|Participants|Standard Deviation|Mean
63959|NCT01171690|Secondary|Safety Analysis|Arms were compared for total number of adverse events, including severe and serious adverse events.|Approximately 90 days after surgery|||events|||Number
63960|NCT01171690|Primary|Hospital Length of Stay|"Hospital length of stay from initiation of therapy with calcium and calcitriol to ready to discharge from a calcium perspective (calcium level > 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for intravenous (IV) calcium in last 24 hours)."|Approximately 7 days after surgery|||days||Standard Deviation|Mean
63961|NCT01171677|Primary|Roesenberg Self Esteem|The Rosenberg Self-Esteem Scale is a 10-item, 4-point Likert scale used to assess global self-esteem. The scale ranges from 0-30 with higher scores indicating higher the self-esteem.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63962|NCT01171677|Primary|Quality of Life (QoL)|The Quality of Life (QoL) assessment is adapted from Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The 23-item QoL consists of five subscales: physical health/activities, feelings, leisure time activities, social relations, and general activities. The scale ranges from 23-115; the higher score indicates higher quality of life enjoyment and satisfaction.|Baseline to end of intervention (week 14)|participants completing intervention||units on a scale||Standard Deviation|Mean
63963|NCT01171677|Primary|Self-Efficacy for Abstinence|The Self-Efficacy for Abstinence assessment is adapted from DiClemente (1994)’s Alcohol Abstinence Self-Efficacy. The modified 10-item, 5-point Likert scale (Not at all to Extremely) assesses confidence in abstaining from alcohol. The scale is comprised of four subscales: negative affect, social/positive, physical and other concerns, and withdrawal and urges. Overall abstinence self-efficacy score is calculated by summing each item. The scale ranges from 10-50, the higher the score the higher the self-efficacy for abstinence.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63964|NCT01171677|Primary|Wechsler Test of Adult Reading (WTAR)|Wechsler Test of Adult Reading (WTAR) measures reading ability. The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63965|NCT01171677|Primary|Controlled Oral Word Association Test (COWAT)|Controlled Oral Word Association Test (COWAT) measures verbal fluency. The assessment consists of three trials; the total score is a sum of all three trials. The scale ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63966|NCT01171677|Primary|Digit Span|Digit span measures attention efficiency. The Digit-span task is used to measure verbal working memory. Two subscales, Digits Forward and Digits Backward, were combined for a total scale range from 0-30, the higher the score the better the working memory.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63967|NCT01171677|Primary|Trailmaking Test B|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline to end of intervention (week 14)|participants completing each arm||seconds||Standard Deviation|Mean
63968|NCT01171677|Primary|Trailmaking Test A|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline to end of intervention (week 14)|participants completing trial||seconds||Standard Deviation|Mean
63969|NCT01171677|Primary|Stroop Color/Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color-Word test is the third subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility and resistance to interference.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63970|NCT01171677|Primary|Stroop Color|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color test is the second subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63971|NCT01171677|Primary|Stroop Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Word test is the first subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63972|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recognition|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recognition is administered immediately after the HVLT Delayed Recall subscale and involves 12 forced choice responses. The HVLT Delayed Recognition scale ranges from 0-24, the higher score associated with greater recognition ability.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63973|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recall is administered 20-25 minutes after the HVLT Total Recall. The HVLT Delayed Recall scale ranges from 0-12, the higher score associated with greater retention.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63974|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Total Recall|The Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Total Recall is the sum of 3 trials in which twelve words are read to and repeated back by subject. The HVLT Total Recall scale ranges from 0-36, the higher score associated with greater verbal learning.|Baseline to end of intervention (week 14)|participants completing each arm||units on a scale||Standard Deviation|Mean
63975|NCT01171612|Secondary|Number of Patients With Adverse Events Related With Antiplatelet Therapy Management|"Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy~We create 3 categories:~Not withdrawal~Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy)~Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days"|90 days after surgery|MACCEs||participants|||Number
63976|NCT01171612|Secondary|Major Haemorrhagic Events|Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage|up to 90 days after surgery|||participants|||Number
63977|NCT01171612|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCEs)|Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest|up to 90 days after surgery|||participants|||Number
63978|NCT01171534|Secondary|Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure|Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.|One year||||||
63979|NCT01171534|Secondary|Quality of Life|Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year||||||
63980|NCT01171534|Secondary|Pain|Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year|too low of an enrollment volume to analyze|||||
63981|NCT01171534|Primary|Performance of DermaClose System in Treatment of Fasciotomy Wounds|Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation|One year|Too low of an enrollment volume to analyze|||||
63982|NCT01171521|Secondary|Pain|Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The scale goes from 0 to 10 with 0 being no pain and 10 being the most severe pain imaginable. It is a visual analog scale so is continuous data.|6 months|||units on a scale||Standard Deviation|Mean
63983|NCT01171521|Primary|Quality of Life|"The SF-12 contains 12 items from the SF-36 Health Survey - . The SF-12 contains one or two items that measure each of the eight concepts included in the SF-36.~The Quality of Life SF-12 is a scale from 0 - 100, in which 0 = poor functioning and 100 = excellent functioning."|6 months|||units on a scale||Standard Deviation|Mean
63984|NCT01171183|Secondary|Retention|number of weeks each participant is on study protocol|12 weeks|Those eligible participants who entered the residential facility and received at least one dose of study medication. One person in the carvedilol group is excluded from all analyses due to not meeting inclusion criteria.||Weeks||Standard Deviation|Mean
63985|NCT01171183|Primary|Urine Toxicology Screens|Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.|based on thrice weekly urine results during the 10-week outpatient phase|Those who completed the residential facility and attended at least one outpatient clinic visit to complete assessments.||percentage of cocaine negative urines||Standard Deviation|Mean
63986|NCT01171118|Primary|AHI - Apnea Hypopnea Index|This is a standard metric used to describe severity of disordered breathing during sleep.Normal healthy subjects would have an AHI value of zero during sleep. Mild disordered breathing would correspond to a value of 5 to 10 events per hours; moderate 10-25; severe would be over 25|2- 2 1/2 hours during study visit|This is a standard size for this type of sleep study and was performed per protocol.||events per hour||Standard Deviation|Mean
63987|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|Activity impairment due to psoriasis (the extent to which psoriasis affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of activity impairment||Standard Deviation|Mean
63988|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|The mean percentage of TWPI due to psoriasis (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which psoriasis decreased productivity (%)* [number of hours worked / (number of hours of work missed due to psoriasis + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any data follow-up were available; n=number of participants with an assessment at given time point.||percentage of TWPI||Standard Deviation|Mean
63989|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Presenteeism (the extent to which psoriasis decreased productivity) is presented as the mean percentage of impairment while working due to psoriasis, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.||percentage of impairment while working||Standard Deviation|Mean
63990|NCT01169987|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Absenteeism, presented as the mean percentage of work time missed due to psoriasis (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with assessment at given time point.||percentage of work time missed||Standard Deviation|Mean
64007|NCT01170949|Primary|Urticaria Activity Score (% Change From Baseline)|The weekly UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories “number of wheals” and “intensity of pruritus”. “Number of wheals” is scored as 0 = no wheals, 1 = some wheals (<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. “Intensity of pruritus” is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42.|Day 28|ITT = 73||percentage of UAS baseline||Standard Deviation|Mean
63991|NCT01169987|Secondary|DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI is a participant-reported outcome consisting of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect. Follow-up visits were classified into time windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of participants|||Number
63992|NCT01169987|Secondary|Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (3), a lot (2), a little (1), or not at all (0). The total DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows, based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||units on a scale||Standard Deviation|Mean
63993|NCT01169987|Secondary|Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|"The PGA was an evaluation of a participant's psoriasis on a 6-point scale: clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5), which were then regrouped into the 2 categories Clear/Minimal or Mild/Moderate/Severe/Very Severe (M/Md/S/VS), and presented as the percentage of participants in each. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)."|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (obs.; up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of participants|||Number
63994|NCT01169987|Secondary|Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status|Clinical psoriasis evaluations by the investigator of percentage of affected BSA. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of affected BSA||Standard Deviation|Mean
63995|NCT01169987|Secondary|PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Percentage of participants who achieved ≥ 50%, 75%, 90% or 100% reduction (improvement) from Baseline in PASI score (PASI50, PASI75, PASI90, PASI100). Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based on the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.||percentage of participants|||Number
64008|NCT01170884|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 12|Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-Treat (ITT) included all subjects who were randomized to study medication.||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
64131|NCT01169311|Secondary|Length of Stay|length of time between time of admission and time of discharge|Day 0, time of discharge minus time of admission|||Minutes||Standard Deviation|Mean
63996|NCT01169987|Secondary|Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed with PASI for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline – score at follow-up visit) / PASI score at Baseline. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at Baseline and given time point.||percentage improvement||Standard Deviation|Mean
63997|NCT01169987|Primary|Adalimumab Treatment Retention Status|Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for < 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups.|Month 24/ Early Termination visit|Intention to Treat (ITT) set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.||percentage of participants|||Number
63998|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From day 8 post last dose of treatment up-to Week 72|Safety population included all treated participants.||participants|||Number
63999|NCT01170962|Secondary|Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.||participants|||Number
64000|NCT01170962|Secondary|Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.||participants|||Number
64001|NCT01170962|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)|SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
64002|NCT01170962|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
64003|NCT01170962|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
64004|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From first dose to last dose plus 7 days, up to 49 weeks|Safety population included all treated participants.||participants|||Number
64005|NCT01170962|Primary|Percentage of Participants With 24-week Sustained Virologic Response (SVR24)|SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
64006|NCT01170962|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4, Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
64009|NCT01170754|Secondary|Safety of Two Competing PEG Preparations|Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|please refer to adverse events table for description||05/2016||||
64010|NCT01170754|Primary|Comparison of the Efficacy, of the Standard Bowel Preparation Golytely With Miralax.|"The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely.~The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:~0 = Unprepared colon segment with mucosa not seen due to solid stool.~= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen.~= Minor amount of residual staining, small fragments of stool and/or opaque liquid~= clear colon without staining"|photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.|||units on a scale||Standard Deviation|Mean
64011|NCT01170663|Other Pre-specified|Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 103 weeks and within 30 days of last dose of study drug|All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received.||participants|||Number
64012|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score|The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.||units on a scale||Standard Deviation|Mean
64013|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status|EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.||units on a scale||Standard Deviation|Mean
64014|NCT01170663|Secondary|Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1 (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
64015|NCT01170663|Secondary|Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 (28-day cycle)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
64016|NCT01170663|Secondary|Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion|This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.|Cycle 1, Day 1 predose (28-day cycles)|Zero participants were analyzed.|||||
64017|NCT01170663|Secondary|Cmax After 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
64018|NCT01170663|Secondary|Cmax After 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
64019|NCT01170663|Secondary|Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion||Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
64020|NCT01170663|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)|Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.|Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks|All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies.||percentage of participants|||Number
64034|NCT01170598|Primary|Grip Strength|Measure of upper-body strength using a Jamar hand dynamometer. Participants were asked to hold and squeeze (the dynamometer) with maximal force. Three trials were completed with each hand, alternating between the right and left to minimize fatigue. The highest recorded value of the dominant hand was used in the analysis.|Baseline, Post-induction (weeks 4-6)|||kilograms||Standard Deviation|Mean
64035|NCT01170598|Primary|Timed 10-chair Stands|Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible.|Baseline, Post-induction (weeks 4-6)|||seconds||Standard Deviation|Mean
64021|NCT01170663|Secondary|Percentage of Participants With CR or PR [Objective Response Rate (ORR)]|ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.||percentage of participants||95% Confidence Interval|Number
64022|NCT01170663|Secondary|Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD|BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.||percentage of participants|||Number
64023|NCT01170663|Secondary|Time to Progressive Disease (TTP)|TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.|Baseline up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94.||months||95% Confidence Interval|Median
64024|NCT01170663|Secondary|Progression-Free Survival (PFS)|PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39.||months||95% Confidence Interval|Median
64025|NCT01170663|Primary|Overall Survival Time (OS)|OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.|Randomization up to 27.5 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.||months||95% Confidence Interval|Median
64026|NCT01170598|Primary|Program Adherence.|Adherence to supervised exercise program assessed as a percentage of exercise sessions completed(number of days of supervised exercise performed/the number of days that patients were approached to participate).|Baseline, Post-induction (weeks 4-6)|||percentage of exercise days completed|||Number
64027|NCT01170598|Primary|Retention|Percentage of participants who remained in the study (did not withdraw voluntarily).|Baseline, Post-induction (weeks 4-6)|||percentage of participants|||Number
64028|NCT01170598|Primary|Recruitment Rate|Ratio of patients who consented to participate out of all eligible patients expressed as a percentage (eligible patients who consented to participation/eligible patients who declined participation).|Baseline|For this outcome measure we analyzed 52 participants (rather than 35). Fifty-two participants met the study eligibility criteria. Thirty-five out of 52 consented to participate which is how we derived our recruitment rate of 67% (35/52).||percentage of patients|||Number
64029|NCT01170598|Secondary|Development of Sepsis|Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course).|Post-induction (weeks 4-6)|||percentage of participants|||Number
64030|NCT01170598|Secondary|Intensive Care Unit (ICU) Admission|Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course).|Post-induction (weeks 4-6)|||percentage of participants|||Number
64031|NCT01170598|Secondary|Length of Stay|Length of stay (date of admission to hospital to date of discharge).|Post-induction (weeks 4-6)|||days||Standard Deviation|Mean
64032|NCT01170598|Secondary|Fatigue|Fatigue will be assessed using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). The FACT-Fatigue consists of 13 questions and has excellent psychometric characteristics. Fatigue scores derived from this questionnaire range from 0-52 with a higher score reflecting lower fatigue.|Baseline, Post-induction (weeks 4-6)|||units on a scale||Standard Deviation|Mean
64033|NCT01170598|Secondary|Global Quality of Life|Global quality of life (QOL) will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used, self-reported, psychometrically sound cancer QOL instrument. QOL scores derived from this questionnaire range from 0-100 with a higher score reflecting a higher QOL.|Baseline, Post-induction (weeks 4-6)|||units on a scale||Standard Deviation|Mean
64132|NCT01169311|Secondary|Intra-Operative Bleeding Requiring Intervention|Incidence of intervention for intra-operative staple-line bleeding|Day 0 - time of surgery|||participants|||Number
64037|NCT01170598|Primary|Peak Aerobic Capacity (VO2peak)|The modified Bruce protocol is a walking-based treadmill test used to assess peak aerobic capacity. As the test progresses the intensity of each 3-minute work load increases. The test concludes when the participant reaches his maximal heart rate or volitional fatigue. The value attained on this test is measured in metabolic equivalents (METS). METS are a measure of exercise intensity and reflect the physical demands of an activity. In this context, a higher value achieved on the treadmill test (in METS) indicates work at a higher intensity and therefore a higher aerobic capacity.|Baseline, Post-induction (weeks 4-6)|||metabolic equivalent (METS)||Standard Deviation|Mean
64038|NCT01170546|Primary|Age||before training|||year||Standard Deviation|Mean
64039|NCT01170546|Primary|Isokinetic Strength|Cybex NORM (Cybex International, Inc, Ronkonkoma, New York, U.S.A.) was employed to evaluate isokinetic muscle strength before and after training.|one year||12/2010||||
64040|NCT01170546|Primary|Agility|shuttle run agility test|one year||12/2010||||
64041|NCT01170546|Primary|Static Knee Stability|The KT-2000 knee ligament arthrometer (MED Metric Co., San Diego, USA) is designed to assess the anterior drawer laxity of the knee joint. The discrepancy of anterior displacement between the sound side and the lesion side is applied in evaluating the static stability of the knee.|one year||12/2010||||
64042|NCT01170533|Primary|Platelet Function as Assessed by the P2Y12 Reactivity Index|P2Y12 reactivity index which will be assessed by flow cytometry determination of vasodilator-stimulated phosphoprotein (VASP).|1 week|A sample size of 18 patients was required to be able to detect a 10% absolute difference in PRI between both regimens with 80% power and 2-sided significance level of 0.05, assuming a 15% standard deviation for the difference between regimens.||Percentage of platelet reactivity index||Standard Error|Least Squares Mean
64043|NCT01170390|Secondary|EE Steady State After Randomization|Steady state levels of ethinyl estradiol (EE) post- randomization|Post-randomiziation 4 months|||ng/mL||Standard Deviation|Mean
64044|NCT01170390|Secondary|EE Steady State Baseline|Steady state levels of ethinyl estradiol (EE) at baseline (2 months)|Baseline (2 months)|One subject discontinued prior to the completion of the baseline cycle in the Aviane/Aviane arm||ng/mL||Standard Deviation|Mean
64045|NCT01170390|Secondary|LNG AUC|Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.|baseline (2 months)|||hr*ng/mL||Standard Deviation|Mean
64046|NCT01170390|Secondary|LNG AUC|Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.|post-randomization (4 months)|||hr*ng/mL||Standard Deviation|Mean
64047|NCT01170390|Primary|LNG Steady State at Baseline and Then Post-randomization|The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).|baseline (2 months) and post-randomization (4 months)|One subject discontinued prior to the completion of the baseline studies in the Aviane/Aviane arm||ng/mL||Standard Deviation|Mean
64048|NCT01170273|Primary|Change in Short Physical Performance Battery Test Score|The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.|baseline and 9 months|||units on a scale||Standard Deviation|Mean
64049|NCT01170221|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.||units on a scale||Standard Deviation|Mean
64050|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the Day 7 Visit|Clinical improvement was defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
64051|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement was defined as improvement in overall clinical status.|48-72 Hour Visit|The Intent to Treat analysis set includes data from all randomized participants.||participants|||Number
64052|NCT01170221|Secondary|To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized patients who received the minimal study therapy, completed EOT and PTE assessments, no concomitant systemic antibiotic therapy through PTE, and had no confounding events or factors.||participants|||Number
64053|NCT01170221|Secondary|Investigator’s Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set included data from all randomized participants.||participants|||Number
64054|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|EOT Day 11|All randomized patients receiving minimal study therapy, completed 48-72 Hour and EOT assessments, no concomitant systemic antibiotic therapy through EOT, and had no confounding events or factors||participants|||Number
64133|NCT01169311|Secondary|OR Time|Duration of procedure|Day 0 - Time of stop minus time of start|||minutes||Standard Deviation|Mean
64062|NCT01170091|Secondary|Clinical Global Impressions-Global Improvement (CGI-I)|"CGI-I comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose CGI-I were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)||patients|||Number
64063|NCT01170091|Secondary|Patient-Global Impressions (PGI-I)|"PGI comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose PGI were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)||patients|||Number
64064|NCT01170091|Secondary|International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment|"a change in 10-item scale rated by the patient on 5 levels with a minimum (none) sum score of 0 to maximum (very severe) sum score of 40"|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose IRLS scores were assessed at the baseline and at 4 weeks after the end of titration. Efficacy data set (Intent to Treat)||Units on a scale||Standard Deviation|Mean
64065|NCT01170091|Primary|Number of Reported Adverse Events|If there is a dose titration, another 4 weeks should be followed up|Up to 4 weeks|Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set||cases|||Number
64066|NCT01170039|Secondary|Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire|The difference in the scores on the self-reported Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The quality of life is measured by the by the overall scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, a validated 28-item questionnaire measuring quality of life as it pertains to constipation. The 28 items are grouped into four subscales, 1) worries and concerns, 2) physical discomfort, 3) psychosocial discomfort, and 4) satisfaction. A 5-point Likert response scale, ranging from 0 (Not at all/None of the time) to 4 (Extremely/ All of the time), is used. The subscale scores vary from 0 to 4 and the total (global) score ranges from 0 to 4. A lower score indicates better quality of life (QOL).|Screening, 8 weeks|7 subjects in the Lubiprostone arm and 7 subjects in the placebo arm did not complete the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire and therefore no data was analyzed for these subjects.||scores on a scale||Standard Deviation|Mean
64067|NCT01170039|Secondary|Number of Subjects With Daily Abdominal Discomfort|The number of subjects experiencing abdominal discomfort was recorded weekly.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|The number of participants in both arms was analyzed by Intention-to-Treat (ITT).||participants|||Number
64068|NCT01170039|Secondary|Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule|The duration of colonic transit time in hours was measured by the SmartPill pH Capsule. Colonic transit time is the time interval from the cecal entry of the capsule to anal expulsion and was measured in hours.|Baseline, 4 weeks|Intention to treat population.||hours||Standard Deviation|Mean
64069|NCT01170039|Primary|Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week|The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|Two subjects in the Lubiprostone arm did not complete the daily stool diary at baseline. No data was analyzed for these two subjects.||spontaneous bowel movements||Standard Deviation|Mean
64070|NCT01169779|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
64071|NCT01169779|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
64072|NCT01169779|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
64097|NCT01169675|Secondary|Disease Control|Disease Control is defined as complete response, partial response, or stable disease according to the response evaluation criteria in solid tumours (RECIST) version 1.1.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||participants|||Number
64073|NCT01169779|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with Baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
64074|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
64075|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
64076|NCT01169779|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
64077|NCT01169779|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
64078|NCT01169779|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
64079|NCT01169779|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
64080|NCT01169753|Primary|"Number of Participants With Fatigue Worst BFI Score"|"Efficacy defined by fatigue worst score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue."|After each 2 week treatment|No analysis completed, study stopped due to slow accrual with only one participant.|||||
64081|NCT01169701|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up|The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.|Month 24|Intent to Treat (ITT): The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.||Percentage of participants|||Number
64082|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)|Blood samples were collected to analyze CRP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||mg/dl||Standard Deviation|Mean
64083|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)|Blood samples were collected to analyze PCR. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||ug/l||Standard Deviation|Mean
80388|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|3 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
64084|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)|Blood samples were collected to analyze NT-proBNP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||pg/mL||Standard Deviation|Mean
64085|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)|Blood samples were collected to analyze MPO. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||U/mL||Standard Deviation|Mean
64086|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)|Blood samples were collected to analyze HbA1c. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||Percentage of HbA1c||Standard Deviation|Mean
64087|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)|Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP). A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||ng/ml||Standard Deviation|Mean
64088|NCT01169701|Secondary|Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)|Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||mL/min/1.73m^2||Standard Deviation|Mean
64089|NCT01169701|Secondary|Renal Function as Measured by Creatinine Clearance|Creatinine clearance was calculated using the Cockroft-Gault formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||mg/min||Standard Deviation|Mean
64090|NCT01169701|Secondary|Renal Function Measured by Serum Creatinine|Serum samples were collected to analyze serum creatinine.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||mg/dl||Standard Deviation|Mean
64091|NCT01169701|Secondary|Percentage of Participants With Major Cardiovascular Events (MACE)|The percentage of participants who experienced MACE were reported. MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.|Month 24|The Intent to Treat (ITT) analysis set: The ITT included participants who received at least one dose of study medication and had at least one post baseline LVMI value.||Percentage of participants|||Number
64092|NCT01169701|Secondary|Pulse Wave Velocity (PWV)|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|Month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.||m/sec||Standard Deviation|Mean
64093|NCT01169701|Secondary|Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure|Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.|Baseline, Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.||mmHg||Standard Deviation|Mean
64094|NCT01169701|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI)|Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women. A negative change from baseline indicates improvement.|Baseline, Month 24|Participants from the Intent to Treat (ITT) analysis set, who had both baseline and month 24 values, were analyzed. The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.||g/m^2.7||Standard Deviation|Mean
64095|NCT01169675|Secondary|Tumour Shrinkage|Tumour shrinkage is defined as the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set: all patients that received treatment of Afatinib or Pemetrexed and who were evaluated for the longest diameter of the target lesions.||participants|||Number
64096|NCT01169675|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurence of tumour progression or death, whichever came first. It was assessed according to RECIST version 1.1 criteria.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||months||95% Confidence Interval|Median
64134|NCT01169311|Primary|Uneventful Creation of a Functional Staple Line at First Firing of Device|Successful creation of staple line at first firing of device during hemorrhoidopexy|about 20 minutes for procedure|||participants|||Number
64098|NCT01169675|Secondary|Objective Response (OR)|"Objective Response is defined as complete response or partial response according to the response evaluation criteria in solid tumours (RECIST) version 1.1.~Complete Response (CR): disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR): at least 30% decrease of the sum of longest diameter (LD) of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions together with an absolute increase in the sum of LD of at least 5 millimeters; Stable Disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD."|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||participants|||Number
64099|NCT01169675|Secondary|Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set|Occurence of DLT during all courses of treatment with Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during all cycles of treatment|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed||participants|||Number
64100|NCT01169675|Primary|Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set|Occurence of DLT during the first course of treatment to determine the maximum tolerated dose (MTD) of Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during the first cycle (days 1-21)|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed that who were evaluable for MTD determination||participants|||Number
64101|NCT01169649|Primary|Overall Response.|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|every 12 weeks|||participants|||Number
64102|NCT01169610|Secondary|Tolerability|Tolerability will be defined by the number of adverse events experienced by patients.|Two years||||||
64103|NCT01169610|Secondary|Prolonged Smoking Abstinence|"Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, “Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?” Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD).~Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained."|Two years||||||
64104|NCT01169610|Secondary|7-day Point Prevalence Smoking Abstinence|Negative response to the question, “Have you used any type of tobacco, even a puff, in the past 7 days.” This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) < 8 parts per million (ppm) during the medication phase.|Two years||||||
64105|NCT01169610|Primary|Heavy Drinking Days|Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.|Two years||||||
64106|NCT01169610|Primary|Continuous Alcohol Abstinence|No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.|Two years||||||
64107|NCT01169558|Secondary|Efficacy: Progression-free Survival|Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.||months||95% Confidence Interval|Median
64108|NCT01169558|Secondary|Efficacy: Time to Disease Progression|Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.||months||95% Confidence Interval|Median
64109|NCT01169558|Secondary|Efficacy: Overall Survival|Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.||months||95% Confidence Interval|Median
64110|NCT01169558|Primary|Safety: Number of Participants With Serious and Specific Adverse Events|A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.|Up to approximately 3 years|The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.||participants|||Number
64111|NCT01169519|Secondary|Hemodynamic Safety and Efficacy|Assessment of pulmonary vascular resistance|10 minutes after completion of sildenafil infusion|||Wood units * m^2||Inter-Quartile Range|Median
64112|NCT01169519|Primary|Maximum Sildenafil Plasma Concentration|Assessment of peak sildenafil plasma concentration.|5 minutes after completion of sildenafil infusion|3 patients were enrolled in this group but in 1 participant, an inadequate plasma sample volume prevented accurate determination of sildenafil concentration.||ng/mL||Standard Deviation|Mean
64113|NCT01169493|Secondary|Left Ventricular End-diastolic Size||6 months|Data not collected.||cubic cm||Standard Error|Mean
64114|NCT01169493|Secondary|Left Ventricular Ejection Fraction (LVEF)||6 months|Data not collected.||percent||Standard Deviation|Mean
64115|NCT01169493|Secondary|NYHA Function Class|The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.|6 months|||units on a scale||Standard Deviation|Mean
64116|NCT01169493|Secondary|6-minute Walk Distance|6-minute walk distance was the distance that a participant could walk in 6 minutes.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||meters||Standard Deviation|Mean
64117|NCT01169493|Secondary|Minnesota Quality of Life Questionnaire|This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||units on a scale||Standard Deviation|Mean
64118|NCT01169493|Secondary|Arrhythmic Events|To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||participants|||Number
64119|NCT01169493|Secondary|Secondary Echocardiographic Endpoints|Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.|6 months|Data not collected.|||||
64120|NCT01169493|Primary|The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.||6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.||percentage of participants|||Number
64121|NCT01169467|Secondary|Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury|Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.|Baseline to 24 hours|Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis.||mmHg||Standard Error|Mean
64122|NCT01169467|Secondary|Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury|Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.||mmHg||Standard Error|Mean
64123|NCT01169467|Secondary|Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury|Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.|24 hours|Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis.||mg/ml||Standard Error|Mean
64124|NCT01169467|Primary|Change in Pressure Reactivity Index (PRx)|"Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).~A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP."|Baseline to 24 hours|Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis.||Pressure Reactivity Index||Standard Error|Mean
64125|NCT01169467|Primary|Variability of Intracranial Pressure (ICP)|Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.||mmHg||Standard Error|Mean
64126|NCT01169311|Secondary|Quality of Life, Mental Component|quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation|Baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.||units on a scale||Standard Deviation|Mean
64127|NCT01169311|Secondary|Quality of Life, Physical Component|Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation|baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.||units on a scale||Standard Deviation|Mean
64136|NCT01169103|Primary|Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months|As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy.|Baseline and 6 months|||mg/L||Standard Deviation|Mean
64137|NCT01169103|Primary|Changes in Lipid Panel|Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy|Baseline and 6 months|||mg/dL||Standard Deviation|Mean
64138|NCT01169103|Secondary|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score|Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5]|Baseline and 6 months|||HOMA-IR score||Standard Deviation|Mean
64139|NCT01169103|Primary|Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months|Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)|Baseline and 6 months|Due to scheduling difficulties one no treatment subject did not perform the MRI portion of the study at either the baseline or the 6 month visit.||mm^2||Standard Deviation|Mean
64140|NCT01169038|Primary|Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.|The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, and eight week assessments was recorded.|8 weeks|In the ITT analysis, we included the values from the last measured value for those who did not complete the trial. We analyzed the measured value at 8 weeks among those subjects who completed 8 weeks of therapy in the per protocol analysis.||liters||Standard Deviation|Mean
64141|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion|Low back left sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
64142|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion|Low back right sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
64143|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Extension Range of Motion|Low back extension range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
64144|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion|Low back flexion range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks|||degrees||Standard Deviation|Mean
64145|NCT01168999|Primary|Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale|"Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating no pain at all and 100 mm indicating the worst pain imaginable."|baseline and immediately following their assigned intervention during the initial session|||units on a scale||Standard Deviation|Mean
64146|NCT01168999|Primary|Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index|The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.|Change from Baseline at 2 weeks|||units on a scale||Standard Deviation|Mean
64147|NCT01168999|Primary|Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale|A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain|Change from Baseline at 2 weeks|||units on a scale||Standard Deviation|Mean
64148|NCT01168999|Primary|Expectation for Treatment Effectiveness|how helpful participants expect the assigned intervention will be in decreasing their low back pain|baseline|||percent expecting less pain|||Number
64149|NCT01168999|Primary|Believability of Placebo|Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT|baseline|||percentage of participants|||Number
64150|NCT01168986|Secondary|Change From Baseline in Neck Extension Range of Motion at 2 Weeks|change in neck extension range of motion over a 2 week period|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||degrees||Standard Deviation|Mean
64151|NCT01168986|Primary|Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale|Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.|Immediate within session change pre to post intervention|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||units on a scale||Standard Deviation|Mean
64152|NCT01168986|Primary|2 Week Change in Disability on the Neck Disability Index|A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||2 week change in units a scale||Standard Deviation|Mean
64213|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 3|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.||Beats per minute||Standard Deviation|Mean
64153|NCT01168986|Primary|2 Week Change in Pain Score on a Numeric Rating Scale|a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data||units on a scale||Standard Deviation|Mean
64154|NCT01168973|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died|Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Safety population: Randomized participants who received any quantity of study drug, grouped by the treatment they actually received.||participants|||Number
64155|NCT01168973|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.|Baseline, prior to infusion for Cycles 3 and 5, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants who received any quantity of study treatment, grouped by the treatment they actually received, who had a baseline and at least 1 post-baseline ADA assessment.||participants|||Number
64156|NCT01168973|Secondary|Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab||Prior to infusion and 1 hour following infusion for Cycles 3 and 5 (21 days/cycle)|Participants assigned to the ramucirumab and docetaxel arm at randomization, who had evaluable ramucirumab pharmacokinetic (PK) data to calculate Cmax and Cmin.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
64157|NCT01168973|Secondary|Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores|The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had an EQ-5D assessment at a baseline and 30 days post treatment.||units on a scale||Standard Deviation|Mean
64158|NCT01168973|Secondary|Maximum Improvement on Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had a baseline and at least 1 post-baseline LCSS score.||mm||Standard Deviation|Mean
64159|NCT01168973|Secondary|Percentage of Participants Achieving Disease Control (Disease Control Rate)|Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.||percentage of participants||95% Confidence Interval|Number
64160|NCT01168973|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.||percentage of participants||95% Confidence Interval|Number
64161|NCT01168973|Secondary|Progression-Free Survival (PFS) Time|PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Randomization to measured PD or date of death from any cause (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 70 participants; placebo and docetaxel arm = 42 participants.||months||95% Confidence Interval|Median
64162|NCT01168973|Primary|Overall Survival|Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Randomization to date of death from any cause (up to 34 months)|Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 200 participants; placebo and docetaxel arm = 169 participants.||months||95% Confidence Interval|Median
64163|NCT01168934|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
64164|NCT01168934|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time (MRAUC [0-∞])|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) (MRAUC [0-∞]).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Ratio||Standard Deviation|Geometric Mean
64165|NCT01168934|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
64166|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
64167|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
64168|NCT01168934|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||ng*hr/mL||Standard Deviation|Geometric Mean
64169|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
64170|NCT01168934|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
66929|NCT01138150|Secondary|Low Molecular Weight (LMW):Total (T)-ADP|serum LMW:T-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ratio||95% Confidence Interval|Mean
64171|NCT01168934|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
64172|NCT01168934|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
64173|NCT01168934|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
64174|NCT01168934|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
64175|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
64176|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
64177|NCT01168934|Secondary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn])|AUClast[dn] = Dose normalized area under the plasma concentration time-curve (AUC[dn]) from zero to the last measured concentration.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL/mg||Standard Deviation|Geometric Mean
64178|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
64179|NCT01168934|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
64180|NCT01168934|Primary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞][dn])|AUC [0 - ∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - ∞) divided by dose.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL/mg||Standard Deviation|Geometric Mean
64181|NCT01168856|Primary|Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688|Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.|Month 18|Resistance monitoring population.||participants|||Number
64192|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.||mmHg||Standard Deviation|Mean
64193|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.||mmHg||Standard Deviation|Mean
64368|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow||Up to 15 months from registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.|||||
64182|NCT01168856|Primary|Number of Participants With STV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.~Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.~Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.||participants|||Number
64183|NCT01168856|Primary|Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.||participants|||Number
64184|NCT01168856|Primary|Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population.||participants|||Number
64185|NCT01168856|Primary|Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.||participants|||Number
64186|NCT01168856|Primary|Number of Participants With DNV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study."|Month 3-18|Resistance monitoring population.||participants|||Number
64187|NCT01168856|Primary|Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.~Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.||participants|||Number
64188|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.||Beats per minute||Standard Deviation|Mean
64189|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.||Beats per minute||Standard Deviation|Mean
64190|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.||Beats per minute||Standard Deviation|Mean
64191|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.||Beats per minute||Standard Deviation|Mean
64194|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.||mmHg||Standard Deviation|Mean
64195|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.||mmHg||Standard Deviation|Mean
64196|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.||mmHg||Standard Deviation|Mean
64197|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.||mmHg||Standard Deviation|Mean
64198|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.||mmHg||Standard Deviation|Mean
64199|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.||mmHg||Standard Deviation|Mean
64200|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.|||||
64201|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.|||||
64202|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.|||||
64203|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.||IU/mL||Standard Deviation|Mean
64204|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.||Percentage of participants|||Number
64205|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.||Percentage of participants|||Number
64206|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.||Percentage of participants|||Number
64207|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.||Percentage of participants|||Number
64208|NCT01168856|Primary|Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm|Percentage of participants who received any anti-HCV medication during the monitoring period was reported.|Up to 18 months|Resistance monitoring population.||Percentage of participants|||Number
64209|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 18|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.||Beats per minute||Standard Deviation|Mean
64210|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.||Beats per minute||Standard Deviation|Mean
64211|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 9|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.||Beats per minute||Standard Deviation|Mean
64212|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.||Beats per minute||Standard Deviation|Mean
64214|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.||mmHg||Standard Deviation|Mean
64215|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.||mmHg||Standard Deviation|Mean
64216|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.||mmHg||Standard Deviation|Mean
64217|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.||mmHg||Standard Deviation|Mean
64218|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.||mmHg||Standard Deviation|Mean
64219|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.||mmHg||Standard Deviation|Mean
64220|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.||mmHg||Standard Deviation|Mean
64221|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.||mmHg||Standard Deviation|Mean
64222|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.||mmHg||Standard Deviation|Mean
64223|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.||mmHg||Standard Deviation|Mean
64224|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.||IU/mL||Standard Deviation|Mean
64225|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.||IU/mL||Standard Deviation|Mean
64226|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.||IU/mL||Standard Deviation|Mean
64227|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.||IU/mL||Standard Deviation|Mean
64228|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.||IU/mL||Standard Deviation|Mean
64229|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.||Percentage of participants|||Number
64230|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.||Percentage of participants|||Number
64231|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.||Percentage of participants|||Number
64232|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.||Percentage of participants|||Number
64233|NCT01168856|Primary|Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).|Month 3|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.||Percentage of participants|||Number
64234|NCT01168726|Secondary|Protective Behavioral Strategies Scale.|Use of protective behavioral strategies related to alcohol use. Higher scores indicate more use of the strategies. A total score was calculated by summing the three subscale scores on the measure (range = 3-18).|6 months|||units on a scale||Standard Deviation|Mean
64235|NCT01168726|Secondary|Drinking Norms Rating Form|Perceived drinking among other students, represented by standardized scores on the Drinking Norms Rating Form. Higher values indicate that the individual perceives higher levels of drinking among other students. Because the scores are standardized their is no hypothetical minimum or maximum, and the scale is standardized with a mean of 0 and standard deviation of 1. So, a mean value of 1.52 means that participants in that condition had an average score that was 1.52 standard deviation above the overall mean of the sample.|6 months|||units on a scale (standardized)||Standard Deviation|Mean
64236|NCT01168726|Primary|Rutgers Alcohol Problems Index (RAPI)|Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.|6 months|||units on a scale||Standard Deviation|Mean
64237|NCT01168726|Primary|Drinks Per Week||6 Months|||drinks per week||Standard Deviation|Mean
64238|NCT01168687|Primary|Standard Alcoholic Drinks Per Treatment Period|The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.|This will be assessed during a 42-day period.|All study participants were used for data analysis. If there were no significant differences between the two doses of levetiracetam, data would be collapsed for analysis.||number of drinks per treatment period||Standard Error|Mean
64239|NCT01168674|Secondary|Predictors of Bipolarity to Define the Study Population|The specific bipolarity predictors in patients with MDD were assessed.|13 weeks|The most common predictor was antidepressant tolerance, as reported below in 37 subjects.||percentage of subjects|||Number
64240|NCT01168674|Primary|MADRS Improvement Over 6 Weeks|"Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods.~Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms.~Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode.~No subscales were used or combined."|13 weeks (Two 6 week periods plus a one week washout)|||units on a scale||Standard Deviation|Mean
64241|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tense|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64242|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Happy|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64243|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tired|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64244|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Energetic|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64267|NCT01168349|Secondary|Percentage of Participants With Vitamins Prescription||Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
66930|NCT01138150|Secondary|High Molecular Weight (HMW): T-ADP|serum HMW:T-ADP levels after treatment in responders and non responders|30 minutes, 60 minutes, 120 minutes after treatment|||ratio||95% Confidence Interval|Mean
64245|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Angry|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64246|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Sad|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64247|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Confused|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64248|NCT01168596|Other Pre-specified|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64249|NCT01168596|Other Pre-specified|Becks Depression Inventory (BDI-II)|The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms.|Change from baseline to week 12|||units on a scale||95% Confidence Interval|Mean
64250|NCT01168596|Other Pre-specified|State-Trait Anxiety Inventory (STAI)|The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64251|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Afraid|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64252|NCT01168596|Other Pre-specified|Marin Apathy Inventory (Apathy Evaluation Scale)|The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64253|NCT01168596|Other Pre-specified|Parkinson's Disease Sleep Scale (PDSS)|The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64369|NCT01167192|Secondary|Number of Participants With Surgical Complications||30 days post surgery (approximately 16-20 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These two patients are not included in this outcome measure.||participant|||Number
64254|NCT01168596|Secondary|Hand-grip Strength|The patients use the hand on the side most affected by Parkinson’s disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||seconds||95% Confidence Interval|Mean
64255|NCT01168596|Secondary|Finger Tapping|The patient is asked to use the index finger on the side most affected by Parkinson’s disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||finger taps per sixty seconds||95% Confidence Interval|Mean
64256|NCT01168596|Secondary|Paced Auditory Serial Addition Test (PASAT)|The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64257|NCT01168596|Secondary|PD Quality of Life Scale (PDQ39)|PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64258|NCT01168596|Secondary|Multidimensional Fatigue Inventory (MFIS)|The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64259|NCT01168596|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64260|NCT01168596|Primary|Modified Fatigue Impact Scale (MFIS)|The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.||units on a scale||95% Confidence Interval|Mean
64261|NCT01168427|Secondary|R-wave Amplitude Measurement|Average R-wave amplitude at implant and 30-days post procedure|Implant procedure and 30 days post-implant procedure||09/2012||||
64262|NCT01168427|Secondary|Physician Satisfaction With Reveal In-office Implants|Observational survey of physicians satisfaction post implant At implant|At implant||09/2012||||
64263|NCT01168427|Secondary|Techniques and Procedures Utilized During Reveal In-office Implants|Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.|At implant||09/2012||||
64264|NCT01168427|Secondary|Surgical Staff Utilized for Reveal In-office Implants|Observational analysis of surgical staff present at the Reveal Implants|At implant||09/2012||||
64265|NCT01168427|Secondary|Number of Participants Having Procedure-related Adverse Events|Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).|From Implant to 90 days post-implant procedure|||participants|||Number
64266|NCT01168427|Primary|Procedure-related Complications Rate Requiring Resolution by Surgical Intervention|This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.|From Implant to 90 days post-implant procedure|Reveal device indicated patients, enrolled in the study and implanted per protocol||participants|||Number
64268|NCT01168349|Secondary|Percentage of Participants With Adequate Iron Status|Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
64269|NCT01168349|Secondary|Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64270|NCT01168349|Secondary|Relative Percent Change in Hb Concentration From Baseline Over the Study Period||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percent change||Standard Deviation|Mean
64271|NCT01168349|Secondary|Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment||Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
64272|NCT01168349|Secondary|Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment|Percentage of participants with at least 1 temporary discontinuation was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64273|NCT01168349|Secondary|Percentage of Participants With Modifications of NeoRecormon® Regimen|All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64274|NCT01168349|Secondary|Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64275|NCT01168349|Secondary|Percentage of Participants With Subcutaneous (SC) Route of Administration||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
64276|NCT01168349|Secondary|Percentage of Participants With Pre-specified Dose and Frequency of Injections|Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.||percentage of participants|||Number
64277|NCT01168349|Secondary|Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks||Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64278|NCT01168349|Secondary|Mean Starting Dose of NeoRecormon® Injection|Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||IU/kg/weeks||Standard Deviation|Mean
64279|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
64280|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
64292|NCT01168349|Primary|Karnofsky Performance Status (KPS): Baseline|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
80389|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|2 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
64281|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
64282|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64283|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64284|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64285|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline|Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64286|NCT01168349|Primary|Mean Number of Days of Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who had at least 1 sick leave without any missing data.||days||Standard Deviation|Mean
64287|NCT01168349|Primary|Percentage of Participants With At Least 1 Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64288|NCT01168349|Primary|Percentage of Participants With Professional Activity: Baseline|Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64289|NCT01168349|Primary|KPS: Week 24 to 28|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
64290|NCT01168349|Primary|KPS: Week 12 to 16|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
64291|NCT01168349|Primary|KPS: Week 4 to 6|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||units on a scale||Standard Deviation|Mean
80390|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|1 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).||ng/mL||Standard Error|Mean
64293|NCT01168349|Primary|Time to First RBC Transfusions|Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||weeks||95% Confidence Interval|Median
64294|NCT01168349|Primary|Mean Number of RBC Units|Mean number of units was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.||RBC units||Standard Deviation|Mean
64295|NCT01168349|Primary|Mean Number of RBC Transfusions|Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.||RBC transfusions||Standard Deviation|Mean
64296|NCT01168349|Primary|Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion|Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants|||Number
64297|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 21 to 42|Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Day 21 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants||95% Confidence Interval|Number
64298|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 28 to 42|Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.|Day 28 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.||percentage of participants||95% Confidence Interval|Number
64299|NCT01168232|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
64300|NCT01168232|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
64301|NCT01168232|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period.|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0|During treatment and up to 30 days after stopping the study treatment|Eligible and Treated Participants||participants|||Number
64302|NCT01168232|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days|Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval||percentage||95% Confidence Interval|Number
64303|NCT01168024|Secondary|Change in Kidney Function Between the Randomized Groups.||Up to 96 hours post-procedure|Change in eGFR was available for 2 treatment and 1 control subject. 1 out of range eGFR value for a subject (0.1) was not used as this value is not clinically feasible.||mL/min/1.73m^2||Standard Deviation|Mean
64304|NCT01168024|Primary|Evaluating Local Events.|"Events evaluated include:~Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death~Pericardial effusions (including pericardial tamponade) requiring treatment"|Through 30 days post-procedure.|||events|||Number
64305|NCT01168024|Primary|Evaluating Bleeding/Transfusion Events.|"Bleeding/transfusion events evaluated:~Blood loss requiring transfusion of ≥ 2 units~Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding~TIMI Minor Bleeding"|Through 30 days post-procedure|||events|||Number
64306|NCT01168024|Primary|Incidence of Contrast Induced Nephropathy (CIN) in Subjects.|CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).|Through 72 hours post-procedure|||participants|||Number
64307|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
64308|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
64309|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.||baseline and 52 weeks|Treated set, all patients treated with at least one dose of randomised study drug.||participants|||Number
64310|NCT01167881|Secondary|The Change in Body Weight From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||kilograms||Standard Error|Mean
64766|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 36 Hours|The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.|36 hours|||percentage of participants|||Number
64311|NCT01167881|Secondary|The Change From Baseline in HbA1c After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
64312|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
64313|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||mmHg||Standard Error|Mean
64314|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.||baseline and 104 weeks|Treated set, all patients treated with at least one dose of randomised study drug.||participants|||Number
64315|NCT01167881|Primary|The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.||Baseline and 104 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
64316|NCT01167881|Secondary|The Change in Body Weight From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||kilograms||Standard Error|Mean
64317|NCT01167829|Secondary|Free Testosterone Mean Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64318|NCT01167829|Secondary|Free T Maximum Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64319|NCT01167829|Secondary|Mean Estradiol Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64320|NCT01167829|Secondary|Maximum Estradiol Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64321|NCT01167829|Secondary|Mean SHGB Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64322|NCT01167829|Secondary|Maximum Sex Hormone-Binding Globulin (SHGB)Concentration||baseline & day 9|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64323|NCT01167829|Secondary|Mean Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64324|NCT01167829|Secondary|Maximum Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64325|NCT01167829|Primary|Mean Testosterone Concentration|initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64326|NCT01167829|Primary|Maximum Testosterone Concentration|initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment|baseline & day 9|per protocol||ng/dL||Geometric Coefficient of Variation|Geometric Mean
64327|NCT01167608|Primary|"3rd Most Commonly Reported Future Barrier to Mental Health Services: Services Are Not Available in my Community"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
64328|NCT01167608|Primary|"2nd Most Commonly Reported Future Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most commonly reported future barrier to mental health services reported by those who responded to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
64329|NCT01167608|Primary|"Most Commonly Reported Future Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
64330|NCT01167608|Primary|"3rd Most Commonly Reported Past Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited access.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
92846|NCT00878800|Primary|Maximum Tolerated Dose (MTD) of Doxorubicin|Maximum Tolerated Dose (MTD) of doxorubicin|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks|||mg/m2|||Number
64331|NCT01167608|Primary|"2nd Most Commonly Reported Past Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
64332|NCT01167608|Primary|"Most Commonly Reported Past Barrier to Mental Health Services: Anyone in my Situation Would be Struggling"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as low mental health literacy.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime|||percentage of total respondents|||Number
64333|NCT01167582|Primary|Red Blood Cell Transfusion|Differences in mean number of units of red blood cell transfusions between the two study arms.|In-hospital up to 30 days post randomization|||blood units||Standard Deviation|Mean
64334|NCT01167582|Secondary|Composite Mortality and Morbidity|Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization and pneumonia.|30 days and 6 months||||||
64335|NCT01167582|Secondary|Pneumonia or Blood Stream Infection and Each Separately||30 days and 6 months||||||
64336|NCT01167582|Secondary|Deep Vein Thrombosis and Pulmonary Embolism||30 days and 6 months||||||
64337|NCT01167582|Secondary|Stent Thrombosis||30 days and 6 months||||||
64338|NCT01167582|Secondary|Congestive Heart Failure||30 days and 6 months||||||
64339|NCT01167582|Secondary|Stroke||30 days and 6 months||||||
64340|NCT01167582|Secondary|Unscheduled Hospital Admission|Unscheduled hospital admission at 30 days and 6 months for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection.|30 days and 6 months||||||
64341|NCT01167582|Secondary|Mortality From Cardiac Causes||30 days and 6 months||||||
64342|NCT01167582|Secondary|Individual Components of Composite Outcome|All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.|30 days and 6 months||||||
64343|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months.|6 months|||participants|||Number
64344|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days.|30 days|||participants|||Number
64345|NCT01167582|Primary|Hemoglobin Concentration|Differences in the mean hemoglobin concentrations between the two study arms.|In-hospital up to 30 days post randomization|||g/dL||Standard Deviation|Mean
64346|NCT01167582|Primary|Trial Feasibility|"the number of eligible study subjects and enrollment rates, overall and by center;~the adherence rates for the transfusion protocol, overall and by center;~the frequencies of proposed outcomes"|6 months||||||
64347|NCT01167504|Secondary|Defined Behaviour of Salivary Film Formation|"A secondary output is a well defined description of the film formation behaviour of normalsaliva in terms of thickness (nm), viscoelastic modulus (mN/m) and temporal behaviour. This will be used to develop model or artificial salivas saliva that forms films in the same way as real saliva ex vivo, that can be used to screen the effects of different compounds and ingredients, without having to collect fresh saliva from human volunteers. The measure is the rate of increase in film thickness (depth, nm) as a function of time, measured by adsorbing whole mouth saliva onto a solid silica surface and measuring the film thickness using Dual Polarisation Interferometry and Quartz Crystal Microbalance."|Within 4 hours of saliva collection.|Literature data and power calculations were used to calculate the number of individuals required to show a statistical significant effect of the presence of ingredients on the thickness of the salivary film.||nm/cm2/min||Standard Deviation|Mean
64348|NCT01167504|Primary|Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces|The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm^2), density (ng/cm^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.|Within 4 hours of saliva collection.|Based on published results of saliva pellicle thickness, power calculations showed that 12 individuals would provide sufficient statistical significance to determine the effect of added ingredients on salivary film thickness.||nm||Standard Deviation|Mean
64349|NCT01167452|Primary|Elimination Rate Constants for Sulfamethoxazole and Trimethoprim||24 hours|||hr-1||Full Range|Median
64350|NCT01167426|Secondary|Patient Injection Experience Preference|"The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. strongly prefer first experience (first 2 weeks); 2. somewhat prefer first experience (first 2 weeks); 3. no preference; 4. somewhat prefer second experience (past 2 weeks); 5. strongly prefer second experience (past 2 weeks). Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience)."|Week 4|Analysis Population with available data.||participants|||Number
66931|NCT01138150|Secondary|Low Molecular Weight (LMW)-ADP|serum LMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
64351|NCT01167426|Primary|Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience|"The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from strongly disagree (score = 1) to strongly agree (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience."|Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).|The Analysis Population consisted of of all patients who received at least one dose of study medication and had satisfaction data at time points 2 and 6 weeks, 2 and 4 weeks, or 2, 4 and 6 weeks.||units on a scale||Standard Deviation|Mean
64352|NCT01167257|Secondary|Net Change of the Global Response Assessment (GRA)|Efficacy:(measured the net change of variables from baseline and 1 month) The Global response assessment (GRA) have seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.|Baseline to 4 weeks after initial treatment|||participants|||Number
64353|NCT01167257|Secondary|Net Change of the Urgency Severity Score (USS) Within 3 Days|Efficacy:(measured the net change of variables from baseline and 1 month) Urgency severity score (USS) within 3 days. The USS have 1-point scale ranging from 0 to 4. The USS grades urgency per toilet void as none, mild, moderate or severe.|Baseline to 4 weeks after initial treatment|||participants|||Number
64354|NCT01167257|Secondary|Net Change of the Postvoid Residual Volume (PVR)|Efficacy:(measured the net change of variables from baseline and 1 month) Postvoid residual volume (PVR) Change = Week 4 minus Baseline value|Baseline and 1 month after initial treatment|||mL||Inter-Quartile Range|Median
64355|NCT01167257|Secondary|Net Change of the Maximum Flow Rate (Qmax)|Efficacy:(measured the net change of variables from baseline and 1 month) Maximum flow rate (Qmax) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||mL/s||Inter-Quartile Range|Median
64356|NCT01167257|Secondary|Net Change of the Functional Bladder Capacity (FBC)|Efficacy:(measured the net change of variables from baseline and 1 month) Functional bladder capacity (FBC) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||mL||Inter-Quartile Range|Median
64357|NCT01167257|Secondary|Net Change of the Overactive Bladder Symptom Score (OABSS)|"Efficacy:(measured the net change of variables from baseline to 1 month) Overactive bladder symptom score (OABSS) The OABSS is a 4-item questionnaire developed to evaluate OAB symptoms. The maximal scores are 2, 3, 5 and 5 for daytime frequency, nighttime frequency, urgency and urgency in continence, respectively.~The OABSS range = 0 to 15 ((asymptomatic to very symptomatic). Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|||units on a scale||Inter-Quartile Range|Median
64358|NCT01167257|Secondary|Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days|"Efficacy:~Mean change of the urgency urinary incontinence (UUI) per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||Frequency per 3 days||95% Confidence Interval|Median
64359|NCT01167257|Secondary|Mean Change of the Urgency Episodes Per 3 Days|"Efficacy:~Mean change of the Urgency episodes per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||Frequency per 3 days||95% Confidence Interval|Median
64360|NCT01167257|Primary|Mean Change of the Total Frequency Per 3 Days|"Efficacy:~Mean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects||Frequency per 3 days||95% Confidence Interval|Mean
64361|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and the Correlation to Tumor Response||Up to 15 months from time of registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.|||||
64362|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancer as Measured by the Genetic Similarity Between the Primary Tumor and the Tumor in Animals||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
64363|NCT01167192|Secondary|Successful Development of Animal Models in Triple Negative Breast Cancers as Measured by the Ability of the Tumors to Metastasize to Other Organs||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
64364|NCT01167192|Secondary|Successful Development of Animal Models for Triple Negative Breast Cancers as Measured by the Ability to Passage the Tumors in Mice||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
64365|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancers as Measured by the Ability to Grow the Tumors in Mice.||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.|||||
64366|NCT01167192|Secondary|Medical Toxicities as Measured by Number of Grade 3 or Higher Adverse Events||30 days post surgery (approximately 16-20 weeks after start of registration)|||adverse event|||Number
64367|NCT01167192|Secondary|Overall Survival Rate||Median follow-up was 59.9 months|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These 2 patients are not included in this outcome measure.||percentage of participants|||Number
64370|NCT01167192|Secondary|Time to Disease Progression|Progression = at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, unequivocal progression of existing non-target lesions.|Up to 5 years from registration|There are 8 participants not included in this outcome measure and the reasons are as follows: (1) removed from study due to treatment related toxicity prior to surgery, (1) expired prior to surgery, and (6) did not have progressive disease.||months||Full Range|Median
64371|NCT01167192|Primary|Relationship Between Tumor Response and Deficiencies in DNA Repair Mechanisms||Prior to surgery (approximately 12-16 weeks from registration)|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.|||||
64372|NCT01167192|Primary|Response Rate as Measured by Number of Participants Who Achieved Complete Response (CR) or Partial Response (PR)|"Complete response (CR) = disappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor marker level.~Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Prior to surgery (approximately 12-16 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to efficacy evaluation and 1 patient expired prior to efficacy evaluation. These two patients are not included in this outcome measure.||Participants|||Count of Participants
64373|NCT01167153|Secondary|Change From Baseline in Orthostatic Pulse at 12 Weeks|Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic pulse rate after baseline.||beats/min||Standard Deviation|Mean
64374|NCT01167153|Secondary|Change From Baseline in Sitting Pulse at 12 Weeks|Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of sitting pulse rate after baseline.||beats/min||Standard Deviation|Mean
64375|NCT01167153|Secondary|Change From Baseline in Orthostatic SBP and DBP at 12 Weeks|The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic SBP and DBP after baseline.||mm Hg||Standard Deviation|Mean
64376|NCT01167153|Secondary|Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks|Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks.|12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of blood pressure control after baseline||Percentage of participants|||Number
64377|NCT01167153|Secondary|Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)|"Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.~Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline."|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of effective BP control after baseline.||Percentage of participants|||Number
64378|NCT01167153|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline.||mm Hg||Standard Deviation|Mean
64379|NCT01167153|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline.||mm Hg||Standard Deviation|Mean
64380|NCT01167140|Secondary|Participants With an Improvement in Global Appearance|• Subjects’ global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline|Up to 4 months|5 subjects were excluded from effectiveness analysis because they received a lower dose.||participants|||Number
64381|NCT01167140|Secondary|Participants With One Point Improvement in Line Severity|• Investigators’ rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline|Baseline and up to 4 months|Of the 41 subjects treated, 5 were treated at a lower dose and excluded from the effectiveness measure.||participants|||Number
64382|NCT01167140|Primary|Number of Participants With Effectiveness and Safety Success|"Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale~Safety success: the absence of a device-related serious adverse event (DSAE)"|Up to 4 months|All subjects treated were analyzed to the safety endpoint.||participants|||Number
64394|NCT01166958|Secondary|Average Bone Mineral Density of the Proximal Femur (Hip) at Baseline, 3 Months and 6 Months|Hip BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.|||g/cm2||Full Range|Mean
92847|NCT00878800|Primary|Maximum Tolerated Dose (MTD) PXD101|Maximum Tolerated Dose (MTD) of PXD101treatment|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks|||mg/m²|||Number
64383|NCT01167023|Secondary|P2Y12 Reaction Units (PRU) as Measured by Accumetrics VerifyNow® P2Y12 (VN P2Y12) at 30 Days|PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. The VN P2Y12 assay is a point-of-care device that measures platelet aggregation with single-use, disposable cartridges. A low PRU reflects stronger inhibition of P2Y12, whereas a high PRU reflects weaker inhibition of P2Y12. The Least Squares Mean values were calculated from a mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRU measurements and a non-missing genotype.||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
64384|NCT01167023|Secondary|Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded intensity of pain due to SCD each day in daily pain diaries using a pain scale. A scale of 0 to 9 was used, with 0=no pain and 9=unbearable pain. A response range of 1 to 9 indicated participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. Pain intensity was the average of a participant's pain ratings. Average pain intensity=(Sum of all nonmissing pain intensity responses/number of daily pain diaries completed). Number of daily pain diaries completed is number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who had recorded the pain intensity in at least 1 daily pain diary.||units on a scale||Standard Deviation|Mean
64385|NCT01167023|Secondary|Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days|PRI was calculated by VASP phosphorylation assay using flow cytometry. The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12. The Least Squares (LS) Mean values were calculated from a mixed-effects model repeated measures (MMRM) analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRI measurements and a non-missing genotype.||percentage of PRI||Standard Error|Least Squares Mean
64386|NCT01167023|Secondary|Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration|Pain requiring medical attention was defined 2 ways: (1) if the participant attended an unplanned doctor’s appointment or clinic visit, visited the emergency room, or was admitted to hospital due to sickle cell pain, or (2) if the participant experienced a vaso-occlusive crisis (VOC), acute chest syndrome, or hepatic sequestration at least once during the treatment period.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who completed at least 1 page of the daily pain diary or with pain endpoint case report form (CRF) data available.||percentage of participants|||Number
64387|NCT01167023|Secondary|Percentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded the intensity of pain due to SCD each day in the daily pain diaries. A scale of 0 to 9 was used, with 0 indicating no pain, and 9 indicating unbearable pain. A response range of 1 to 9 indicated the participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. The percentage of days with pain (pain rate) was calculated as follows: Pain rate = 100*(Total number of days with pain/number of daily pain diaries completed). Number of daily pain diaries completed was number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who recorded pain intensity in at least 1 daily pain diary.||percentage of days||Standard Deviation|Mean
64388|NCT01167023|Secondary|Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment Duration|TEAEs were defined as AEs that occurred or worsened after receiving the study drug.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.||percentage of participants|||Number
64389|NCT01167023|Primary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration|A hemorrhagic event requiring medical intervention. Medical intervention was defined as any medical attention resulting in therapy or further investigation during the 30-day treatment duration.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.||percentage of participants|||Number
64390|NCT01166997|Primary|Major Bleeding and Intracranial Bleeding at 30 Days.|Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.|30 days|||participants|||Number
64391|NCT01166997|Primary|Reduction of RV/LV Ratio|Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.|24 hours|||Ratio||Standard Deviation|Mean
64392|NCT01166971|Primary|Defocus Curve|A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”.|3 months after surgery|In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.||LogMAR||Standard Deviation|Mean
64393|NCT01166958|Secondary|Average Bone Mineral Density of the One-third Radius at Baseline, 3 Months and 6 Months|One-third radius BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.|||g/cm2||Full Range|Mean
64395|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum P1NP)|Serum P1NP was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.|||mcg/L||Full Range|Mean
64396|NCT01166958|Secondary|Average Bone Mineral Density of the Spine at Baseline, 3 Months and 6 Months|Spine BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.|||g/cm2||Full Range|Mean
64397|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum CTX)|Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.|||ng/mL||Full Range|Mean
64398|NCT01166763|Secondary|OH Vitamin D Levels in Serum|Assessment of 25(OH)D levels as a measure of circulating vitamin D.|baseline and 6 months|All subjects completing trial||ng/ml||Standard Deviation|Mean
64399|NCT01166763|Secondary|Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.|Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.|baseline and 6 months|All subjects completing trial.||percentage of cells staining positive||Full Range|Median
64400|NCT01166763|Primary|Change in Mammographic Breast Density Over Course of Study|Change in the percent of the breast area that is considered to be at higher density on mammogram.|baseline and 6 months|All subjects completing trial||Change in percent dense breast area||Standard Deviation|Mean
64401|NCT01166750|Secondary|Quality of Life||weekly for 12 weeks||||||
64402|NCT01166750|Secondary|Mood and Stress||weekly for 12 weeks||||||
64403|NCT01166750|Primary|Pain|Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.|weekly for 12 weeks|They were the ones still remaining at the end of the study.||units on a scale||Standard Deviation|Mean
64404|NCT01166659|Secondary|Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline|The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.|Baseline, Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.||medications|eyes|Standard Deviation|Mean
64405|NCT01166659|Secondary|Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication|Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.|Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.||percentage of eyes|eyes||Number
64406|NCT01166659|Primary|Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.|Baseline; Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.||percentage of eyes|eyes||Number
64407|NCT01166646|Secondary|"Number of Subjects Whose Signs of Psoriasis Was Designated Success"|Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) “success” and “failure” with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period).|Day 15|"Analysis shown is based on the number of subjects whose Signs of Psoriasis was designated Success (ITT population) at Day 15."||participants|||Number
64408|NCT01166646|Secondary|Changes in Disease Severity (Success)|Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. ODS evaluations will be dichotomized to “success” and “failure” with success defined as a grade of 1 or 0 at the end of treatment (EOT).|Day 15|Analysis shown is based on the ITT population at Day 15.||participants|||Number
64409|NCT01166646|Primary|Pharmacokinetic Properties (AUC)|Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetics properties were evaluated in a subgroup of 12 adult subjects per arm.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
64410|NCT01166646|Primary|Pharmacokinetic Properties (Tmax)|Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.||Hours||Full Range|Geometric Mean
64411|NCT01166646|Primary|Pharmacokinetic Properties (Cmax)|Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
64412|NCT01166646|Primary|Adrenal Suppression Potential|Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment.|After 1-2 weeks dose|Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.||participants|||Number
64426|NCT01166178|Secondary|Course of Disease in Multiple Sclerosis Patients|The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist.|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64413|NCT01166282|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either probably related to study drug, possibly related to study drug, probably not related, or not related to study drug.~For more details on adverse events please see the AE section below."|Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks)|Safety population: All randomized subjects who received at least 1 dose of study drug||participants|||Number
64414|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)|The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used.|Baseline and Week 12|ITT population||percentage of participants|||Number
64415|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)|The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used.|Baseline and Week 12|ITT population||percentage of participants|||Number
64416|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)|The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data.|Baseline and Week 12|ITT population||percentage of participants|||Number
64417|NCT01166282|Secondary|Swollen Joint Count (SJC68): Change From Baseline to Week 12|Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population||units on a scale||Standard Deviation|Mean
64418|NCT01166282|Secondary|Tender Joint Count (TJC72): Change From Baseline to Week 12|Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population||units on a scale||Standard Deviation|Mean
64419|NCT01166282|Secondary|Number of Sites of Enthesitis: Change From Baseline to Week 12|The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population||sites of enthesitis||Standard Deviation|Mean
64420|NCT01166282|Primary|Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12|A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline and Week 12|ITT population||percent change||Standard Deviation|Mean
64421|NCT01166230|Secondary|Rate of Progression|"Only patients with Ta/T1 were included in the follow-up study. Progression is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence."|4.5 years|||percentage of patients|||Number
64422|NCT01166230|Primary|Recurrence Free Survival||up to 4.5 years|Intention-to-treat (ITT)||months||95% Confidence Interval|Median
64423|NCT01166230|Other Pre-specified|Median Time to Recurrence||up to 4.5 years|ITT||months||95% Confidence Interval|Median
64424|NCT01166230|Other Pre-specified|Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB|To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.|up to 5.5 years retrospectively|ITT||percentage of paticipants|||Number
64425|NCT01166178|Secondary|Adverse Events and Serious Adverse Events Comparison of Treatment Groups|Adverse Events and Serious Adverse events are reported in the safety section.|24 months|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. The sample size was not powered for comparison between groups; however, all AEs are reported in the safety section.|||||
64427|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 24 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64428|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip Region at 24 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64429|NCT01166178|Primary|Change in Bone Mineral Density of the Total Hip Region at 12 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64430|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 24 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64431|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 12 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64432|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip at 6 Months|Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64433|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 6 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64434|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 6 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64435|NCT01166178|Primary|Change in Bone Mineral Density of the Lumbar Spine at 12 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.|||||
64436|NCT01166126|Secondary|Number of Participants With Related Serious Adverse Events (SAEs)|Toxicities assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.|1 year|||participants|||Number
64437|NCT01166126|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months.|"Patients will be evaluated by physical examination and imaging assessments (brain MRI and CT scans of the chest, abdomen and pelvis). Disease progression will be defined by RECIST criteria on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|6 months from day 1 of treatment|||participants|||Number
64438|NCT01166126|Primary|Number of Participants With Overall Survival (OS) at One Year|The one-year overall survival of the combination of temsirolimus and AZD6244 Hydrogen Sulfate.|1 year post last treatment|||participants|||Number
64439|NCT01166126|Primary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Anti-tumor response (CR+PR) was defined by Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|1 year|All participants||participants|||Number
64440|NCT01165996|Secondary|Proportion of Patients With Particular Genetic Abnormalities Detected by Whole Exome Sequencing Correlation With Clinical Response|Proportion of patients with particular genetic abnormalities detected by whole exome sequencing correlation with clinical response|Baseline||03/2013||||
64444|NCT01165996|Secondary|Cytogenetic Response as Per IWG Criteria|Described as the number of patients with a major cytogenetic response (refers to disappearance of a cytogenetic abnormality) or a minor cytogenetic response (50% or more reduction of abnormal metaphases).|at 12 months|Patients that had cytogenetic abnormalities at baseline.||participants|||Number
64445|NCT01165996|Secondary|Number of Patients That Experience > Grade 2 Non-hematologic Toxicity by National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) v4 Criteria|Incidence of treatment-emergent adverse events (AEs) will be presented in tables that include causality, seriousness, severity/grade, and whether the AE resulted in death or discontinuation of treatment, Laboratory data will be summarized in tables that show changes from pre-treatment values and frequencies of abnormal values. Descriptive statistics will also be provided.|up to 12 months of treatment|All patients that received treatment.||participants|||Number
64446|NCT01165996|Primary|Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia|The criteria for complete remission (CR) and partial remission (PR) involve specific improvements in marrow and peripheral blood measurements obtained on 2 or more successive assessments. The response parameters in peripheral blood must be maintained for at least 8 weeks. Responses designated as CR include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L (11 g/dL) or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease classification category than prior to treatment.|Formal assessment at week 12 for study primary end-point (hematologic improvement).|All patients enrolled and that received any treatment.||participants|||Number
64447|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
64448|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
64449|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
64450|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
64451|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
64452|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
64453|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
64454|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
64455|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
64456|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
64457|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL||12 Weeks post-randomization|||μg/mL||Inter-Quartile Range|Median
64458|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL||12 Weeks post-randomization|||pg/mL||Inter-Quartile Range|Median
64459|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
64460|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL||12 Weeks post-randomization|||ng/mL||Inter-Quartile Range|Median
64461|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).|12 Weeks post-randomization|||percent change over baseline||Inter-Quartile Range|Median
64462|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.|Baseline|||percentage change over baseline||Inter-Quartile Range|Median
64463|NCT01165983|Primary|Nitroglycerine Induced Vasodilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|12 Weeks post-randomization|||percent change||Inter-Quartile Range|Median
64464|NCT01165983|Primary|Nitroglycerin Induced Dilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|Baseline|||percent change||Standard Deviation|Mean
64465|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|12 Weeks post-randomization|Number of subjects that completed the study||percent change over baseline||Inter-Quartile Range|Median
64466|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|Baseline|||percentage change over baseline||Standard Deviation|Mean
64467|NCT01165840|Primary|Serum Clearance|Serum clearance of dapsone|72 hours|||L/h||Standard Deviation|Mean
64468|NCT01165775|Secondary|Neonatal Hypoglycemia||birth to discharge|Neonates from birth to discharge. The maternal patients received betamethasone to minimize the complications of prematurity. Maternal blood glucose levels were monitored using the Dexcom Seven Plus Continuous Glucose Monitoring System.||participants|||Number
64513|NCT01165281|Secondary|Number of Patients Who Discontinued Due to Lack of Efficacy|The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy.|4 weeks|Time to discontinuation due to lack of efficacy was not analyzed since there was only 1 patient in the per-protocol set (in the tapentadol group) who discontinued treatment due to lack of efficacy.||Number of participants|||Number
64469|NCT01165775|Primary|Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment|During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (>110;>144;>180)|24-48 hours post betamethasone treatment|Seventeen women were enrolled at the time of betamethasone administration and data were available for 15 patients.||percentage time||Standard Deviation|Mean
64470|NCT01165684|Secondary|Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment.|Week 0 to Week 32|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. 397 subjects contributed with data.||Episodes /year of patient exposure|||Number
64471|NCT01165684|Secondary|Body Mass Index (BMI) at Week 32|Estimated mean BMI after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.||kg/m^2||Standard Error|Mean
64472|NCT01165684|Secondary|Body Weight at Week 32|Estimated mean body weight after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.||kg||Standard Error|Mean
64473|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32|Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 352 subjects contributed to the statistical analysis at Week 32.||mmol/L||Standard Deviation|Mean
64474|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 343 subjects contributed to the data at Week 21.||mmol/L||Standard Deviation|Mean
64475|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 326 subjects contributed to the data at Week 10.||mmol/L||Standard Deviation|Mean
64476|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 32|Estimated Mean FPG at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.||mmol/L||Standard Error|Mean
64477|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 21|Mean FPG at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the data at Week 21.||mmol/L||Standard Deviation|Mean
64478|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 10|Mean FPG at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 368 subjects contributed to data at Week 10.||mmol/L||Standard Deviation|Mean
64479|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32|Proportion of subjects reaching HbA1c below 7.0% at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.||percentage (%) of subjects|||Number
64480|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21|Proportion of subjects reaching HbA1c below 7.0% at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.||percentage (%) of subjects|||Number
64481|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10|Proportion of subjects reaching HbA1c below 7.0% at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.||percentage (%) of subjects|||Number
64482|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21|Estimated mean change from baseline in HbA1c after 21 Weeks of treatment|Week 0, Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.||percentage of glycosylated haemoglobin||Standard Error|Mean
64483|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10|Estimated mean change from baseline in HbA1c after 10 Weeks of treatment|Week 0, Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.||percentage of glycosylated haemoglobin||Standard Error|Mean
64484|NCT01165684|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32|Estimated mean change from baseline in HbA1c after 32 Weeks of treatment|Week 0, Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.||percentage of glycosylated haemoglobin||Standard Error|Mean
64485|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.|Post flutemetamol administration.|||Percent of Specificity-Normal Reads||95% Confidence Interval|Number
64486|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.|Post flutemetamol administration.|||Percent of Sensitivity-Abnormal Reads||95% Confidence Interval|Number
64487|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.|"A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader N) divided by the (Total number of normal participants).~Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images."|Post Flutemetamol administrations|The assessment was done post-mortum based on the estimates of the presence of amyloid plaque in the brain.||Percentage of Specificity by Reader|||Number
64488|NCT01165554|Primary|The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.|"A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader N) divided by the (Total number of abnormal participants).~Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β."|Post flutemetamol administration.|The assessments were post-mortum based on the estimates of the presence of amyloid plaque in the brain.||Percentage of Sensitivity by Reader|||Number
64489|NCT01165541|Primary|Number of Very Heavy Drinking Days Per Week|The number of “very heavy” drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week|14 Weeks|The Analysis Population only consists of participants that completed both phases of the study.||days||Standard Deviation|Mean
64490|NCT01165450|Secondary|Percent Reduction of Corneal Epithelial Defect at Day 28 ± 2 in the Study Eye|To compare, in each of the two patient populations, the percent reduction in epithelial defect size at Day 28 ± 2 compared to baseline, as measured by slit lamp examination with fluorescein staining. Epithelial defect size determined by pseudo-area, defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
64491|NCT01165450|Secondary|Persistence of Complete Corneal Re-epithelialization in the Study Eye|To determine whether or not complete corneal re-epithelialization was persistent, as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye. The measurement will be made at Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
64492|NCT01165450|Secondary|Change in the Rate of Re-epithelialization of the Study Eye|"To determine the change in the rate of re-epithelialization of the study eye from the screening run-in period to the treatment period, if applicable.~Time Frame: Screening period is defined as Day -7 to Day 0 ± 1. Treatment period is defined as Day 0 ± 1 through time of complete re-epithelialization. Time of complete re-epithelialization is defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2."|35 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
64493|NCT01165450|Secondary|Complete Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|To determine binary indicator of whether or not healing has occurred at 14 ± 1 days, defined as the largest diameter of the epithelial defect being smaller than 0.5 mm as determined by slit lamp examination with fluorescein staining.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
64494|NCT01165450|Secondary|Time to Complete Re-epithelialization of the Study Eye|Resolution of epithelial defect is defined as the largest diameter of the epithelial defect being less than 0.5 mm, as it is difficult to distinguish a smaller defect from the small amount of fluorescing staining seen in a healed defect. Time of complete re-epithelialization will be defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
64495|NCT01165450|Primary|Incidence of Adverse Events Following Application of the Investigational Product in All Subjects|Primary safety measure: To determine incidence of adverse events by recording their occurrence at each study visit through Day 28 ± 2. Analysis of safety data will be performed prior to each dose-escalation. If greater than 2 serious adverse events are found that are causally related to the investigational product, the study will be halted.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
64496|NCT01165450|Primary|Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|Primary efficacy measure: To determine whether topical treatment of persistent epithelial defects with Nexagon preparations yields greater healing at Day 14 ± 1, compared to vehicle alone, in individuals having had diabetic vitrectomy. Healing will be determined by comparing pseudo-area (as measured by Investigator, or designated ophthalmologist) at baseline (taken just prior to the first treatment) and Day 14 ± 1. Pseudo-area is defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.|||||
64497|NCT01165424|Secondary|Change From Baseline in the Total Nasal Symptom Score|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.|Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)|All treated participants||units on a scale||Standard Error|Mean
64498|NCT01165424|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions||Baseline to Week 24|All treated participants||participants|||Number
64499|NCT01165320|Primary|Percentage of Participants With One or More Drug-Related Adverse Experiences|An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.|Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days|The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for safety outcomes.||Percentage of Participants|||Number
64500|NCT01165320|Primary|Percentage of Participants With an Overall Favorable Response to Therapy|Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.|Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days|"The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for response to therapy. Participants whose overall response assessment was unable to judge were counted as having an unfavorable response."||Percentage of Participants|||Number
64501|NCT01165307|Secondary|Subject Satisfaction at 12 Months|Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||participants|||Number
64502|NCT01165307|Secondary|Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)|The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||mm||Inter-Quartile Range|Median
64503|NCT01165307|Secondary|Bleeding Pattern at 12 Months|"The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea normal pattern (none of the above patterns)."|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||participants|||Number
64504|NCT01165307|Secondary|Indirect Medical Costs|Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||dollars||Standard Deviation|Mean
64505|NCT01165307|Secondary|Direct Medical Costs|Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||dollars||Standard Deviation|Mean
64506|NCT01165307|Secondary|Change in Ferritin From Baseline||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||ug/L||Inter-Quartile Range|Median
64507|NCT01165307|Secondary|Ferritin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||ug/L||Inter-Quartile Range|Median
64508|NCT01165307|Secondary|Change in Hemoglobin||baseline, 12 months|Only subjects who completed the 12 month visit were included in the analysis.||g/dL||Inter-Quartile Range|Median
64509|NCT01165307|Secondary|Hemoglobin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||g/dL||Inter-Quartile Range|Median
64510|NCT01165307|Secondary|Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )|The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||units on a scale||Inter-Quartile Range|Median
64511|NCT01165307|Secondary|Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||units on a scale||Standard Deviation|Mean
64512|NCT01165307|Primary|Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).|The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.||units on a scale||Inter-Quartile Range|Median
64514|NCT01165281|Secondary|Proportion of Patients Entering the Maintenance Period|Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period.|4 weeks|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Percentage of Participants|||Number
64515|NCT01165281|Secondary|Proportion of Patients With Various Levels of Pain Improvement (Responders)|The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period.|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Percentage of Participants|||Number
64516|NCT01165281|Secondary|Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.||Milligrams||Standard Deviation|Mean
64517|NCT01165281|Secondary|Frequency of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.||Number of doses per day||Standard Deviation|Mean
64518|NCT01165281|Secondary|Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories|The PGIC was rated by the patient and was based on the single question “Since the start of this treatment, my cancer-related pain overall is,” where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline, Endpoint of the 4-week Treatment Period|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Percentage of Participants|||Number
64519|NCT01165281|Primary|Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale|The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: “What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine.” The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration.|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).||Scores on scale||Standard Deviation|Mean
64520|NCT01165216|Secondary|Serum Half-life (T-HALF) of Ipilimumab|T-HALF was calculated as the ratio of ln(2) to elimination rate constant (K), where K was estimated as negative slope obtained by regression of the terminal log-linear portion of the serum concentration vs time profile following the ipilimumab dose on Day 1 of Cycle 3. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods, using a validated PK analysis program. Actual times were used for the analyses. T-HALF measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||Days||Standard Deviation|Mean
64521|NCT01165216|Secondary|Time of Maximum Observed Serum Concentration (Tmax)|Tmax was recorded directly from experimental observations. Actual times were used for the analyses. Tmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||Hours||Full Range|Median
64529|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Reason for Incorrect Inhaler Use and Who Required Additional Instruction the Indicated Number of Times at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed based on 3 steps: open the device, inhale the dose, and close the device. If the participants did not perform the maneuvers correctly, the step of the inhaler use that was performed incorrectly by the participants was recorded. The entire procedure was demonstrated once again. and the number of times that the participants required additional instruction (RAI) was recorded.|Baseline, Week 2, and Week 4|ITT Population. Only those participants who used the inhaler incorrectly at the specified time points were analyzed.||participants|||Number
64522|NCT01165216|Secondary|Area Under the Concentration Curve From Time 0 to Day 21 (in 1 Interval Dosing) (AUC[0-21d]) for Ipilimumab|The AUC(0-21d) was calculated using a mixture of log- and linear-trapezoidal summations. Using no weighting factor, the terminal log-liner phase of the concentration-time curve was determined by least-square linear regression of at least 3 data points. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods using a validated PK analysis program. Actual times were used for the analyses. AUC(0-21d) measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
64523|NCT01165216|Secondary|Trough Observed Serum Concentration (Cmin) of Ipilimumab|Cmin was recorded directly from experimental observations. Actual times were used for the analyses. Cmin measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 (Day 8), and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||ug/mL||Standard Deviation|Mean
64524|NCT01165216|Secondary|Maximum Serum Concentration (Cmax) of Ipilimumab|Cmax was recorded directly from experimental observations. Actual times were used for the analyses. Cmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab||ug/mL||Geometric Coefficient of Variation|Geometric Mean
64525|NCT01165216|Secondary|Number of Participants With Best Overall Response (BOR) of Partial Response (PR) or Stable Disease|Tumor response was determined for all participants with measurable lesions by radiologic responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The BOR was the best response recorded from start of treatment until disease progression/recurrence. RECIST for target lesions: PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started. At minimum, tumor measurements were to be obtained at screening, every 6 weeks (±1 week) during the induction phase and every 12 weeks (±1 week) during the maintenance phase.|Day 1 of Cycle 3, Day 1 of Cycle 5, and Day 22 of Cycle 6|Participants who received at least 1 dose of study drug||Participants|||Number
64526|NCT01165216|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. AE incidence was assessed from Day 1 until Week 24 and every 12 weeks thereafter during the maintenance period, until discontinuation of study drug, due to progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure, and at least every 4 weeks(±1 week) until all study drug-related toxicities had recovered to resolved, stabilized or returned to baseline or were deemed irreversible during the follow-up period).|Continuously from Day 1 to Week 24 and every12 weeks thereafter during maintenance until discontinuation of drug|Participants who received at least 1 dose of any study drug||Participants|||Number
64527|NCT01165216|Primary|Number of Participants Experiencing a Dose-limiting Toxicity (DLT)|A DLT was defined as study drug-related adverse event occurring during the first 2 cycles after ipilimumab administration in the induction phase and was any of the following: Grade 4 absolute neutrophil count (ANC) decreased (<500 cells/ mm^3) for 7 or more consecutive days; febrile Neutropenia (body temperature ≥38.5° C with ANC <1000 /mm^3) lasting >3 days; Grade 4 platelet count decreased (<25,000 cells/mm^3) or Grade 3 platelet count decreased requiring a platelet transfusion; Grade 3 or greater nausea, vomiting, diarrhea, despite the use of adequate/maximal medical intervention; Grade 3 or greater aspartate transaminase/alanine transaminase level and rash that has not resolved to Grade 2 or lower within 2 weeks after onset; or any Grade 3 or greater nonhematologic toxicity (except Grade 3 fatigue, Grade 3 asthenia, Grade 3 transient arthralgia/myalgia, or Grade 3 transient abnormal electrolyte levels).|Day 1 of Cycles 1 and 2 From Day 1 of Cycle 3 to Day 21 of Cycle 4|Participants who received at least 1 dose of ipilimumab||Participants|||Number
64528|NCT01165138|Secondary|Serial FEV1 Over 0-1 Hour Post-dose at Randomization|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Randomization. Serial FEV1 measurements after 5, 15, and 30 minutes and 1 hour post-dose were assessed. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a repeated measures model adjusted for baseline, region, sex, age, treatment group, and planned time points.|Randomization|ITT Population. Serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed||Liters||Standard Error|Least Squares Mean
64530|NCT01165138|Other Pre-specified|Number of Participants Who Used the Inhaler Correctly or Incorrectly at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed.|Baseline (BL), Week 2 (W2), and Week 4 (W4)|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
94465|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 2|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 2|FAS (LOCF)||participants|||Number
64531|NCT01165138|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare were recorded.|From Baseline up to Week 12/Early Withdrawal|ITT Population||Number of visits||Standard Deviation|Mean
64532|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Responses at Week 4, Week 8, and Week 12/Early Withdrawal|At the end of Week 4, Week 8, and Week 12/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptom); much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 8, and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
64533|NCT01165138|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Score at Week 12|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12/Early Withdrawal minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.||Scores on a scale||Standard Error|Least Squares Mean
64534|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
64535|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
64536|NCT01165138|Other Pre-specified|Number of Participants With Bronchodilator Effect|Bronchodilator effect is defined as an increase of FEV1 (defined as the maximal amount of air that can be forcefully exhaled in one second) from Baseline of both 12% and 200 milliliters (mL) during 24 hours, which was evaluated using the serial FEV1 measurements at Baseline (Visit 3).|Baseline|ITT Population. Only the subset of participants performing serial measurements were analyzed.||participants|||Number
64537|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-4 Hours Post-dose at Baseline and Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean serial FEV1 over 0-4 hours was calculated using the serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 12 was performed. Only those participants available at the specified time points were analyzed.||Liters||Standard Deviation|Mean
64538|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Baseline|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 was performed.||Liters||Standard Deviation|Mean
64580|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score <2.6|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64539|NCT01165138|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1 at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 12 clinic visit. The highest of 3 technically acceptable measurements was recorded. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Week 12|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 12 was performed.||Liters||Standard Error|Least Squares Mean
64540|NCT01165138|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 12/Early Withdrawal|ITT Population||participants|||Number
64541|NCT01165138|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.||Score on a scale||Standard Error|Least Squares Mean
64542|NCT01165138|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
64543|NCT01165138|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
64544|NCT01165138|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 12 FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed at Week 12.||Liters||Standard Error|Least Squares Mean
64545|NCT01165138|Primary|Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the Week 12 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, region, sex, age, and treatment group. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing m|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.||Liters||Standard Error|Least Squares Mean
64546|NCT01165047|Primary|Number of Participants With Side Effects and/or Adverse Events|A phone contact will be made to the subject 5 days after the trial to assess general health status and collect information on any reported side effects or adverse events.|5 days|||participants|||Number
64939|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 8|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.||participants|||Number
64547|NCT01165021|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Enrollment until the first date of objectively determined PD or death up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=3.||months||95% Confidence Interval|Median
64548|NCT01165021|Secondary|Overall Survival (OS)|OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.|Enrollment until the date of death from any cause up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=8||months||95% Confidence Interval|Median
64549|NCT01165021|Secondary|Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0|Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.||percentage of participants||95% Confidence Interval|Number
64550|NCT01165021|Secondary|Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]|pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100.|At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)|Participants who received at least 1 dose of preoperative chemotherapy and had surgical tumor tissue samples available.||percentage of participants||95% Confidence Interval|Number
64551|NCT01165021|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.||percentage of participants||95% Confidence Interval|Number
64552|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Urine Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples). Data for parent drug (RO5185426) and metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.||percentage of total dose administered||Standard Deviation|Mean
64553|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Urine of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples), Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.||percentage of total radioactivity||Standard Deviation|Mean
64554|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Fecal Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over 2 time intervals (0-24 + 24-48 hours, 48-72 + 72-96 hours) for measurement of 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, glucuronide) levels.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.||percentage of total dose administered||Standard Deviation|Mean
64579|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64555|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Feces of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over two time intervals for this analysis (0-24 + 24-48 hours, 48-72 + 72-96 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, and glucuronide) are reported.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.||percentage of total radioactivity||Standard Deviation|Mean
64556|NCT01164891|Primary|Plasma 14C-labeled RO5185426 and 14C-labeled Metabolite Levels|Collection of samples for radioactivity continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48 hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). The concentrations were measured in nanogram equivalent per gram which was calculated based on ratio of dosed radioactivity and the last dose of RO5185426. The concentration values represented the drug portion of the last dose. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.||nanogram equivalent per gram||Standard Deviation|Mean
64557|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Plasma of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.||percentage of total radioactivity||Standard Deviation|Mean
64558|NCT01164891|Primary|14C-labeled RO5185426 Recovery: Percentage of Dose Excreted in Feces and Urine|Urinary and fecal samples were analyze for the percentage dose recovered as total radioactivity. The radioactivity was determined on a Packard liquid scintillation counter. Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|Urine:0 hour (pre dose),in quantitative fraction(0-6,6-12,12-24 hours) post dose on Day 15,during 24 hour interval thereafter;Feces:From Day 14 upto pre dose on Day 15,during 24 hour interval post dose until recovery criterion;(maximum:432 hours for both)|PK Analysis Population. One participant was excluded in the analysis because of contamination of urine sample with feces.||percentage of dose recovered||Standard Deviation|Mean
64559|NCT01164891|Primary|AUC Ratio of Blood:Plasma 14C-labeled RO5185426|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analysed = participants with measurable data for this outcome.||ratio||Standard Deviation|Mean
64560|NCT01164891|Primary|Half-life of 14C-labeled RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||hour||Standard Deviation|Mean
64561|NCT01164891|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUClast) of 14C-RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1mSv.|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||(micrograms equivalent/milliliter)*hour||Standard Deviation|Mean
64562|NCT01164891|Primary|Time to Reach Cmax in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||hours||Full Range|Median
64563|NCT01164891|Primary|Maximum Plasma Concentration of 14C-labeled RO5185426 (Cmax) in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1 millisieverts (mSv).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.||micrograms equivalent per milliliter||Standard Deviation|Mean
64564|NCT01164891|Secondary|Overall Survival|Overall survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until death (maximum 841 days)|The data was not collected, as planned, due to small number of participants enrolled in the study.|||||
64565|NCT01164891|Secondary|Number of Participants With a Response by Confirmed Best Overall Response|Best overall response (according to Response Evaluation Criteria In Solid Tumors 1.1 criteria) was defined as best response recorded from start of treatment until disease progression which included complete response (CR) or partial response (PR) that had been confirmed by second tumor assessment no less than (<) 4 weeks after criteria for response were first met. Confirmed CR: disappearance of all target and non-target lesions; no new lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). Confirmed PR: at least 30% decrease in sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression: at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until disease progression, withdrawal from study or death (maximum 841 days)|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
64566|NCT01164891|Primary|Plasma RO5185426 Trough Concentrations on Days 15,16, and 17||Pre-dose on Days 15, 16 and 17|Pharmacokinetic (PK) Analysis Population: participants from whom the level of radioactivity recovered from excreta (urine and feces) was ≤ 1% of the radioactivity in the administered dose between any two successive 48-hour interval assessments.||micrograms per milliliter||Standard Deviation|Mean
64567|NCT01164865|Primary|Likert Questionnaire Scores at 2 Weeks|The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.|2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.||Units on a scale||95% Confidence Interval|Least Squares Mean
64568|NCT01164865|Primary|Change From Baseline in Ocular Comfort Rating at 2 Weeks|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described how your eyes feel right now."|Baseline (Day 0), 2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.||Units on a scale||95% Confidence Interval|Least Squares Mean
64569|NCT01164722|Secondary|Incidence of Metachronous Lesions|Number of patients with one or more metachronous lesions|one year on study|Patents with any biopsy from randomization to one year||Participants|||Count of Participants
64570|NCT01164722|Secondary|Recurrence Rate at 1 Year||1 year on study|Patients who were treated with IRC, no data were collected on patients on the expectant management arm||Percentage of lesions that recurred|||Number
64571|NCT01164722|Secondary|Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year|Number of patients who had high grade anal intraepithelial neoplasia at one year.|1 year on study|Patients who had an evaluable biopsy within one year after randomization.||Participants|||Count of Participants
64572|NCT01164722|Secondary|Tolerability and Safety of Infrared Coagulator Ablation|Number of patients who experienced a serious adverse events|All study visits through year 2|||participants|||Number
64573|NCT01164722|Primary|Complete Response Through 1 Year|No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.|1 year post treatment|All study participants who were randomized and attended the baseline visit.||participants|||Number
64574|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number ten. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 10|||a ratio of pixels||Standard Error|Mean
64575|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number seven. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 7|||a ratio of pixels||Standard Error|Mean
64576|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising in based on a ratio of pixels on post-operative day number three. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 3|||a ratio of pixels||Standard Error|Mean
64577|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) <2.6|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64578|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) â‰¤3.2|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64935|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
64581|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score â‰¤3.2|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64582|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64583|NCT01164579|Secondary|Change From Baseline in DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
64584|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity. DAS28-4 (ESR) â‰¤3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
64585|NCT01164579|Secondary|Change From Baseline in DAS28-3 (CRP)|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
64586|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (â‰¤)3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<)2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assess for the specified parameter at a given visit.||score on a scale||Standard Deviation|Mean
64587|NCT01164579|Secondary|Percentage of Participants With an ACR 70% Improvement (ACR70) Response|ACR70 response: â‰¥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64588|NCT01164579|Secondary|Percentage of Participants With an ACR 50% Improvement (ACR50) Response|ACR50 response: â‰¥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assess for the specified parameter at a given visit.||percentage of participants|||Number
64589|NCT01164579|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response|ACR20 response: greater than or equal to (â‰¥)20% improvement in tender joint count; â‰¥20% improvement in swollen joint count; and â‰¥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Months 1, 2, 3, 6, 9, and 12|FAS Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders. n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
64590|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in Erosion Score|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
64591|NCT01164579|Secondary|Erosion Scores at Months 6 and 12|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
64592|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in JSN Scores|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
64617|NCT01164137|Primary|Health Services Utilization 9 Months Following Hospital Discharge|Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|9 Months|||Health Services Utilizations||Standard Error|Mean
64593|NCT01164579|Secondary|Joint Space Narrowing (JSN) Scores at Months 6 and 12|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||score on a scale||Standard Error|Least Squares Mean
64594|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in mTSS|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) + erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Error|Least Squares Mean
64595|NCT01164579|Secondary|Modified Total Sharp Score (mTSS) at Months 6 and 12|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||score on a scale||Standard Error|Least Squares Mean
64596|NCT01164579|Secondary|Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions|Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.|Months 1, 3, 6, and 12|Evaluable Set||score on a scale||Standard Error|Least Squares Mean
64597|NCT01164579|Secondary|Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP|Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€“3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€“33% of bone edematous; 2: 34â€“66% of bone edematous; 3: 67â€“100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.|Months 1, 3, and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.||score on a scale||Standard Error|Least Squares Mean
64598|NCT01164579|Secondary|Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Months 1, 6, and 12|Evaluable Set||score on a scale||Standard Error|Least Squares Mean
64599|NCT01164579|Primary|Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema|Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.|Month 6|Evaluable Set||score on a scale||Standard Error|Least Squares Mean
64600|NCT01164579|Primary|Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Month 3|Evaluable Set: all randomized participants who received at least 1 dose of the randomized investigational drug and for whom a variable is nonmissing at both baseline and the specified timepoint.||score on a scale||Standard Error|Least Squares Mean
64601|NCT01164501|Other Pre-specified|Hypoglycaemic Events|Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values <= 70 mg/dL (<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.|From first drug administration until 7 days after last trial medication intake, up to 458 days|Treated set which included all patients treated with at least one dose of randomised trial medication.||percentage of participants|||Number
64940|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
64602|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
64603|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
64604|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.||percentage of HbA1c||Standard Error|Mean
64605|NCT01164475|Secondary|Terminal Elimination Half-life (T1/2)|T1/2 is the time required for the plasma concentration to decrease to one half.|0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||hours||Standard Deviation|Mean
64606|NCT01164475|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all patients who have signed informed consent and received at least one dose of study drug.||hours||Full Range|Median
64607|NCT01164475|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||ng/mL||Standard Deviation|Mean
64608|NCT01164475|Secondary|Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor|Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.|Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||fold increase||Standard Deviation|Mean
64609|NCT01164475|Secondary|Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||10^6 cells/kg||Full Range|Median
64610|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.||days||Full Range|Median
64611|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.||days||Full Range|Median
64612|NCT01164475|Secondary|Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >= 2*10^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||percentage of participants|||Number
64613|NCT01164475|Primary|Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||nanogram*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
64614|NCT01164475|Primary|Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.||percentage of participants|||Number
64615|NCT01164137|Primary|Health Services Utilization 18 Months Following Hospital Discharge|Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|18 months|||Health Services Utilizations||Standard Error|Mean
64616|NCT01164137|Primary|Health Services Utilization 12 Months Following Hospital Discharge|Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|12 months|||Health Services Utilizations||Standard Error|Mean
84994|NCT00955513|Primary|Measure: Pain on Movement on Day 5 (Change From Baseline).|Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.|baseline and day 5|||mm||Standard Deviation|Mean
64618|NCT01164137|Primary|Health Services Utilization 6 Months Following Hospital Discharge|Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|6 Months|||Health Services Utilizations||Standard Error|Mean
64619|NCT01164137|Primary|Health Services Utilization 3 Months Following Hospital Discharge|Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|3 Months|||Health Services Utilizations||Standard Error|Mean
64620|NCT01163955|Primary|Posture Control of Head Position, Shoulder Position and Back Position|Forward Head Position (FHP), Rounded Shoulder Position (RSP), and Thoracic spine (T/s)-Lumbar spine (L/s) positions were scored. Subscale scores of 0-3 for each FHP, RSP, and T/s L/s position were obtained. Score 0 was a perfect posture score, Score 1 was 0-1 inches out of alignment. Score 2 was 1-2 inches out of alignment. Score 3 was 2-3 inches out of alignment. Subscale scores were combined for a total score with a minimum value of 0 and a maximum value of 9. 0 being a perfect posture score, 9 being the worst postural score.|5 minute|||scores on a scale||95% Confidence Interval|Mean
64621|NCT01163916|Secondary|Duration of Treatment With Adalimumab|Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.|For the duration of the study (up to a maximum of 18.2 months).|Safety set.||weeks||Full Range|Median
64622|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment|Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.|Baseline and at each follow-up visit (up to a maximum of 18.2 months).|Safety set||participants|||Number
64623|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Duration of Disease|Duration of disease was defined as the time from diagnosis until study entry.|Baseline|Safety set||months||Full Range|Median
64624|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Disease Severity|Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.|Baseline|Safety set.||participants|||Number
64625|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Marital Status|Participants were asked to indicate their marital status at the Baseline visit.|Baseline|||participants|||Number
64626|NCT01163916|Secondary|Percentage of Participants With Missed or Delayed Injections|Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.|For the duration of the study (up to a maximum of 18.2 months).|Safety set; the analysis only includes participants with non-missing data.||percentage of participants|||Number
64627|NCT01163916|Secondary|Patient's Acceptability of Self-injections|"At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were convenient, inconvenient and unable to self-inject.~The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.~Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization."|Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.|The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.||participants|||Number
64628|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Residence Status|Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.|Baseline|||participants|||Number
64629|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Occupation|Participants were asked to indicate their occupation at the Baseline visit.|Baseline|||participants|||Number
64630|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Education Level|Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.|Baseline|||participants|||Number
64631|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Laboratory Parameters|Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic TEAEs. TEAEs (all causalities), treatment related TEAEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
64632|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Electrocardiogram (ECG) Parameters|ECG is used to measure the rate and regularity of heartbeats, as well as the size and position of the chambers, the presence of any damage to the heart, and the effects of drugs or devices used to regulate the heart. ECG parameters RR interval, PR interval, QRS complex, QT interval, [Bazett's Correction], QTcF interval [Fridericia's Correction] were assessed to identify systemic TEAEs. TEAEs (all causalities), treatment related TEAEs and CTCAE severity grades for AEs were reported.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
64813|NCT01162304|Secondary|Brief Pain Inventory|Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
64633|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Vital Signs|Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic TEAEs. TEAEs (all causalities), treatment related TEAEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
64634|NCT01163851|Secondary|Number of Participants With Anti-Drug-Antibodies (ADA)|Participants with positive antibody titer greater than 0 International Units/milliliter (IU/mL) was considered as antibody positive.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
64635|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Identified by Physical Examination|Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic TEAEs.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
64636|NCT01163851|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 64 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs (all causalities), treatment related TEAEs and common terminology criteria for adverse events (CTCAE) severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade.|Baseline up to Day 64|SAS population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
64637|NCT01163851|Secondary|Number of Participants With Toxicity or Intolerable Dose Criteria|Toxicity criteria included any of the following : serious adverse event (SAE), increased liver transaminases (alanine aminotransferase [ALT]/aspartate aminotransferase (AST) , increased bilirubin (in absence of ALT/AST elevations), pancreatitis, creatine kinase (CK) , hyper or hypoglycemia, decreased platelet count, increased serum creatinine, diarrhea, enteritis or nausea, prolongation of QTcF interval [Fridericia's Correction] and other considered appropriate by investigator.|Baseline, Days 1, 2, 3, 4, 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Safety Analysis Set (SAS) population included all participants who met the study enrollment criteria and had received any amount of study medication.||participants|||Number
64638|NCT01163851|Secondary|Durability of Additional Lipid Lowering Effects of PF-04950615 (RN316) in Combination With Atorvastatin on Days 4-64|The median duration of the lipid-lowering effects (decrease in LDL-C levels by greater than or equal to 15 percent [%] compared to baseline) of PF-04950615 in combination with atorvastatin from Days 4 to 64 was reported.|Day 4 to Day 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||days||Full Range|Median
64639|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver.. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
64640|NCT01163851|Secondary|Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|HDL cholesterol is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
64641|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
64642|NCT01163851|Secondary|Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
64643|NCT01163851|Secondary|Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
64644|NCT01163851|Secondary|Percent Change From Baseline in Total Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||percent change||Standard Deviation|Mean
64645|NCT01163851|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|LDL cholesterol is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'n' is signifying those participants who were evaluable for particular category for each arm group respectively.||percent change||Standard Deviation|Mean
64646|NCT01163851|Secondary|Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|HDL cholesterol is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
64647|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
64648|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
64649|NCT01163851|Secondary|Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
64650|NCT01163851|Secondary|Change From Baseline in Fasting Non-High-density Lipoprotein-Cholesterol (Non-HDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
64651|NCT01163851|Secondary|Change From Baseline in Fasting Total Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.||mg/dL||Standard Deviation|Mean
64652|NCT01163851|Secondary|Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|LDL cholesterol is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'n' is signifying those participants who were evaluable for particular category for each arm group respectively.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
64653|NCT01163851|Primary|Apparent Volume of Distribution (Vz/F) of Atorvastatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||liter||Standard Deviation|Geometric Mean
64842|NCT01162096|Secondary|Engraftment, Immune Reconstitution, GVHD||6 months||||||
64843|NCT01162096|Primary|Overall Survival|Number of patients alive at 6 months post-transplant|6 months|||participants|||Number
64654|NCT01163851|Primary|Apparent Oral Clearance (CL/F) of Atorvastatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||L/hr||Standard Deviation|Geometric Mean
64655|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of Atorvastatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||hrs||Standard Deviation|Mean
64656|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
64657|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||hrs||Full Range|Median
64658|NCT01163851|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||ng*hr/mL||Standard Deviation|Geometric Mean
64659|NCT01163851|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615 (RN316)|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||ng*hr/mL||Standard Deviation|Geometric Mean
64660|NCT01163851|Primary|Volume of Distribution at Steady State (Vss) of PF-04950615 (RN316)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||liter||Standard Deviation|Geometric Mean
64661|NCT01163851|Primary|Systemic Clearance (CL) of PF-04950615 (RN316)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||liter/hour (L/hr)||Standard Deviation|Geometric Mean
64662|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of PF-04950615 (RN316)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||hrs||Standard Deviation|Mean
64663|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04950615 (RN316)||0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
64664|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 (RN316)||0 (pre-dose on Day 4), 1, 4, 8 and 12 hrs post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||hrs||Full Range|Median
64665|NCT01163851|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 (RN316)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
64666|NCT01163760|Other Pre-specified|Comfort While Working on Computer|"Comfort throughout the day was evaluated via subjective question: Comfort while working on computer and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week-follow-up|||percentage of participants|||Number
64667|NCT01163760|Secondary|Comfort Throughout the Whole Day|"Comfort throughout the day was evaluated via subjective question: Comfort throughout the whole day and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week follow-up|Subjects analyzed were those enrolled, randomized, and completed the study.||percentage of participants|||Number
64668|NCT01163760|Primary|Lens Comfort|"Lens comfort was evaluated via the subjective question: How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? (excellent/very good=5...very good=3...Poor=0)"|1-week follow-up|Subjects analyzed were those who were enrolled, randomized, and completed the study.||units on a scale||Standard Deviation|Mean
64669|NCT01163747|Secondary|Number of Participants With Adverse Events Through Week 8|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any AE that is fatal or is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|8 weeks|All participants who received at least one dose of study treatment were included in the safety evaluation.||participants|||Number
64670|NCT01163747|Secondary|Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 7F, 8, 9N, 12F, 14, 18C, 19F and 23F."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine. N indicates the number of participants with available data for each serotype. No imputation was performed.||percentage of participants|||Number
64671|NCT01163747|Secondary|Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination|Levels of anti-tetanus antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.||IU/mL||Standard Deviation|Mean
64672|NCT01163747|Secondary|Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination|Levels of anti-pneumococcal antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.||mg/L||Standard Deviation|Mean
64673|NCT01163747|Secondary|Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination|A positive response to the tetanus toxoid vaccination was defined as antibody levels ≥ 0.2 IU/mL for participants with Baseline tetanus antibody levels < 0.1 IU/mL, or a 4-fold increase in antibody levels compared with Baseline for participants with Baseline tetanus antibody levels ≥ 0.1 IU/mL.|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.||percentage of participants||95% Confidence Interval|Number
64674|NCT01163747|Secondary|Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.||percentage of participants||95% Confidence Interval|Number
64675|NCT01163747|Primary|Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.||percentage of participants||95% Confidence Interval|Number
64676|NCT01163721|Primary|Change From Baseline in Fasting Serum Glucose at Week 12|Serum glucose was measured following an overnight fast. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Full Analysis Set||mg/dL||Standard Error|Least Squares Mean
64677|NCT01163721|Primary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal|2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a standardized meal. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||mg/dL||Standard Error|Least Squares Mean
64678|NCT01163721|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a blood test to measure blood sugar control over the prior 3-month period. The last observation carried forward (LOCF) method was used: the last observed post-baseline measurements prior to Week 12 carried forward for participants with no available Week 12 values. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.||percent of HbA1c in blood||Standard Error|Least Squares Mean
64679|NCT01163656|Primary|Time to Tracheal Intubation|The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.|Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.|||seconds||95% Confidence Interval|Median
64680|NCT01163617|Secondary|Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)|||seconds||90% Confidence Interval|Mean
64681|NCT01163617|Secondary|Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)|||seconds||90% Confidence Interval|Mean
64682|NCT01163617|Primary|Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)|||seconds||90% Confidence Interval|Mean
64683|NCT01163617|Primary|Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector|Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied.|Phase A (Week 0 and Week 2)|||cm||Standard Deviation|Mean
64684|NCT01163604|Secondary|Clinical Endpoints||at one year||||||
64685|NCT01163604|Secondary|Various Adverse Effects||at one year||||||
64686|NCT01163604|Secondary|NIHSS, mRS|NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy.|at one year||||||
64687|NCT01163604|Primary|Number of Participants With Occlusion and Restenosis at One Year|Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100%|at one year|||participants|||Number
64688|NCT01163474|Secondary|Feasibility||1 month||||||
64689|NCT01163474|Secondary|Acceptability|Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).|1 month|||units on a scale||Standard Deviation|Mean
64690|NCT01163474|Primary|Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)|Using CVT software and desktop webcams on the VA private network, “Virtual” CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits. Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions. Accuracy was assessed by comparing the 2 reviewers’ CVT decisions to the FTF decision.|1 month|||percentage of agreement|||Number
64691|NCT01163461|Primary|Speech Production|percent change in the number of untrained words spoken correctly|Baseline to one week post treatment termination and three months post treatment termination|||% change score of untrained real words||Standard Deviation|Mean
64692|NCT01163318|Secondary|Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit|MHAQ was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatic diseases. Participants assessed their ability to do each task over the past 6 months using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0 represented no disability and 3 very severe, high-dependency disability. MHAQ score ≤ 0.5 was defined as clinical remission, signifying normal physical function. Data are presented as percentage of participants.|Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.||Percentage of participants|||Number
64706|NCT01163279|Secondary|Stanford Patient Education Research Center- Communication With Physicians Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
66932|NCT01138150|Secondary|Middle Molecular Weight (MMW)-ADP|serum MMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
64693|NCT01163318|Secondary|Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit|DAS28-4ESR, a combined index that measured activity of rheumatoid arthritis, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); and (4) ESR. DAS28-4ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28-4ESR scores indicate improvement of disease. DAS28-4ESR score < 2.6 was defined as clinical remission of rheumatoid arthritis. Data are presented as percentage of participants.|Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.||Percentage of participants|||Number
64694|NCT01163318|Secondary|Incidence of Infections and Malignant Tumors|Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.||Percentage of participants|||Number
64695|NCT01163318|Primary|Incidence of Adverse Drug Reactions (ADRs)|An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.||Percentage of participants|||Number
64696|NCT01163292|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.|Week 0 to Week 52|All participants registered||participants|||Number
64697|NCT01163292|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Weeks 0, 26, and 52|All participants with post-baseline HAQ-DI data, using LOCF imputation method||units on a scale||Standard Deviation|Mean
64698|NCT01163292|Secondary|Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52|Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Week 0 to Week 52|All participants with post-baseline mTSS data, using LOCF imputation method||units on a scale||Standard Deviation|Mean
64699|NCT01163292|Secondary|Matrix Metalloprotease-3 (MMP-3)|MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)|Weeks 0, 26, and 52|All participants with post-baseline MMP-3 data, using LOCF imputation method||units on a scale|||Number
64700|NCT01163292|Primary|Disease Activity Score (DAS28)|The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Weeks 0, 26, and 52|All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.||units on a scale||Standard Deviation|Mean
64701|NCT01163279|Secondary|DKEFS Trail Making- Condition 4: Number-letter Switching|DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Time in seconds||Standard Deviation|Mean
64702|NCT01163279|Secondary|DKEFS Word Fluency|This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Number of words generated||Standard Deviation|Mean
64703|NCT01163279|Secondary|DKEFS Tower Test- Achievement Score|This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
64704|NCT01163279|Secondary|Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time|This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Time in seconds||Standard Deviation|Mean
64705|NCT01163279|Secondary|Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||number of visits||Standard Deviation|Mean
64901|NCT01161407|Secondary|"Bone Balance From Calcium Kinetics"|Calcium kinetics was determined by a calcium radiotracer. Bone balance is the difference between bone formation and bone resorption estimated by calcium kinetic modeling.|2 weeks|||mg/d calcium||Standard Error|Least Squares Mean
64707|NCT01163279|Secondary|Stanford Patient Education Research Center- Physical Activity Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||hours of physical activity/week||Standard Deviation|Mean
64708|NCT01163279|Secondary|Stanford Patient Education Research Center- Health Distress Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
64709|NCT01163279|Secondary|Stanford Patient Education Research Center- General Health Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||units on a scale||Standard Deviation|Mean
64710|NCT01163279|Secondary|General Self Efficacy Scale (GSE)|GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||Scores on scale||Standard Deviation|Mean
64711|NCT01163279|Primary|Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)|COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.|Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).||percentage of untrained goals improved|Total number of goals||Number
64712|NCT01163266|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
64713|NCT01163266|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
64714|NCT01163266|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~The HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
64715|NCT01163266|Secondary|Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score-by-week as fixed effects.|Week 8|Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
64716|NCT01163266|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
64717|NCT01163266|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
64718|NCT01163214|Secondary|Number of Subjects Who Experienced Neurological Changes Postoperatively|Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.|6 weeks postoperative|The number of participants analyzed in the nerve block arm varied because data were not available for all participants in all neurological categories. The sample size for the periarticular injection arm was 79 because neurological data were not collected on 2 participants.||participants|||Number
64719|NCT01163214|Secondary|Length of Stay in Hospital|Length of stay data were calculated from the medical record.|Approximately 2 days after surgery|The number of participants analyzed were different than the baseline values for the arms because data were not available for some participants.||days||Standard Deviation|Mean
64720|NCT01163214|Secondary|Straight-leg Raise|Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.|Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon|The number of participants analyzed varied at each category time point because either data points were missing for participants, or as the condition of the participants improved, they were discharged from the hospital. Number of participants per arm for each time point is shown in each category label.||participants|||Number
64721|NCT01163214|Secondary|Narcotic Use|Use of additional narcotic medications (as needed), measured in morphine equivalents.|Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2|Intention to treat analysis||mg||Standard Deviation|Mean
64722|NCT01163214|Primary|Post-Operative Pain|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|Intention to treat analysis||units on a scale||Standard Deviation|Mean
64723|NCT01163214|Secondary|Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|In the nerve block arm 5 subjects were excluded (3 subjects were not treated as planned, and 1 subject received a sciatic catheter instead of a single injection, and 1 subject previously had a nerve block procedure.) In the periarticular injection arm 4 patients were excluded (3 subjects were not treated as planned, and 1 subject was too heavy.)||units on a scale||Standard Deviation|Mean
64724|NCT01163162|Primary|24-hour Urine Creatinine Excretion Rate|We expect the 24 hour urine creatinine excretion rate to show no differences between groups.|1 Week|||mg/24hour/day||95% Confidence Interval|Mean
64725|NCT01163162|Secondary|Serum Creatinine|We expect serum creatinine to confirm the results of creatinine clearance.|1 Week|||mg/dl/day||95% Confidence Interval|Mean
64726|NCT01163162|Secondary|Creatinine Clearance|The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.|1 Week|||ml/min||95% Confidence Interval|Mean
64727|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
64728|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
64729|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
64730|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
64731|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
64732|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
64733|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||Standard Deviation|Mean
64734|NCT01163097|Secondary|Subject Incidence of Proteinuria|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.~Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||participants|||Number
64735|NCT01163097|Secondary|Subject Incidence of Treatment-emergent Adverse Event|Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C).|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C)||participants|||Number
64736|NCT01163097|Secondary|Palifermin PK Parameters: Vss|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||mL/Kg||Geometric Coefficient of Variation|Geometric Mean
64737|NCT01163097|Secondary|Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||mL/kg||Geometric Coefficient of Variation|Geometric Mean
64738|NCT01163097|Secondary|Palifermin PK Parameters: C0|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng/mL||Geometric Coefficient of Variation|Geometric Mean
64739|NCT01163097|Secondary|Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng/mL||Geometric Coefficient of Variation|Geometric Mean
64740|NCT01163097|Secondary|Palifermin PK Parameters: AUC (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
64741|NCT01163097|Secondary|Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
64742|NCT01163097|Secondary|Palifermin PK Parameters: CL|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
64764|NCT01162863|Primary|Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline|Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm|21-28 days|||hours||Standard Deviation|Mean
64743|NCT01163097|Secondary|Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics (PK) population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
64744|NCT01163097|Primary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.||ratio||95% Confidence Interval|Geometric Mean
64745|NCT01163097|Primary|Ratio to Baseline of Lipase.|Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.||ratio||95% Confidence Interval|Geometric Mean
64746|NCT01163097|Primary|Ratio to Baseline of Amylase|Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.||ratio||95% Confidence Interval|Geometric Mean
64747|NCT01163097|Primary|Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.|"Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects.~The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)"|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.||proportion of participants|||Number
64748|NCT01163097|Primary|Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.|This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment.|Day 4|The pharmacodynamic population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C) and had both baseline and Day 4 buccal biopsy samples collected. This analysis was only performed for Treatment A relative to Treatment B as per study plan.||ratio||90% Confidence Interval|Geometric Mean
64749|NCT01163032|Secondary|Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only)|Adverse events were recorded in the source documents from the time of the patient’s informed consent signature until the end of the patient’s study participation. An AE was defined as any untoward medical occurrence in a clinical investigation patient who does not necessarily have causal relationship with treatment.|6 months|One subject who rolled into the OLE from the randomized phase (tasimelteon) experienced an unrelated TEAE during the OLE phase.||participants|||Number
64750|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 2 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
64751|NCT01163032|Post-Hoc|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 45 Minutes) and UQ-dTSD (≤ 45 Minutes)|Responder analysis with responder defined as an increase of 45 minutes or more in (LQ-nTST) and a decrease of 45 minutes or more in (UQ-dTSD).|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
64752|NCT01163032|Secondary|Average Midpoint of Sleep (MoST)|Midpoint of Sleep Timing (MoST) is the measurement of the average midpoint of sleep time relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||minutes||Standard Error|Mean
64753|NCT01163032|Secondary|Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD)|UQ-dTSD measures the difference in average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) between the randomized phase (6 months) and the screening phase (~ 6 weeks). Lower number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||minutes||Standard Error|Mean
64765|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 12 Hours|Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL|12 hours|||percentage of participants|||Number
86131|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||participants|||Number
64754|NCT01163032|Secondary|Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST)|LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized phase (6 months)and the screening phase (~ 6 weeks). The higher number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||minutes||Standard Error|Mean
64755|NCT01163032|Secondary|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes)|The sleep/wake response represents measurement of the combined improvement in the nighttime sleep duration and daytime sleep duration. Individuals that have an improvement in nighttime sleep and daytime sleep, defined as an increase of 90 minutes or more in the lower quartile of subjective nighttime total sleep time (LQ-nTST) and a decrease of 90 minutes or more in the upper quartile of daytime total sleep duration (UQ-dTSD) are considered to be a responder.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
64756|NCT01163032|Secondary|Average Clinical Global Impression of Change (CGI-C)|CGI-C scores range from 1 (very much improved) to 7 (very much worse). The average post-randomization score was obtained for each patient by averaging the last 2 scheduled assessments (Day D112 and Day D183). Lower number indicates improvement.|Day 112 and 183|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||score||Standard Error|Mean
64757|NCT01163032|Secondary|Proportion of Patients Entrained as Assessed by Urinary Cortisol|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four 48 hour periods, approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.||percentage of patients|||Number
64758|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
64759|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 2 on the Non-24 Clinical Response Scale (N24CRS) which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline~For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
64760|NCT01163032|Primary|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline~For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)||percentage of patients|||Number
64761|NCT01163032|Primary|Proportion of Patients Entrained as Assessed by Urinary aMT6|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.||percentage of patients|||Number
64762|NCT01162863|Secondary|Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index|Change in the motility index defined as the natural log [(sum of pressure amplitudes times the number of contractions) + 1] for the small bowel and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days|||units on a scale||Standard Deviation|Mean
64763|NCT01162863|Secondary|Change in Small Bowel pH and Colon pH From Baseline|Change in the mean pH of the small intestine and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days|||pH||Standard Deviation|Mean
64902|NCT01161407|Secondary|Phosphorus Balance|Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces.|2 weeks|||mg/d phosphorus||Standard Error|Least Squares Mean
64767|NCT01162499|Secondary|Peak Glucagon Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various 3 hours after the start of the infusion. The mean peak glucagon concentration for both Exendin-(9-39) doses were compared with the peak glucagon during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences in peak glucagon concentration were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||pg/ml||Standard Error|Mean
64768|NCT01162499|Secondary|Peak Plasma Glucagon-like Peptide-1 (GLP-1) Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon-like peptide-1 levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion. The mean peak glucagon-like peptide-1 concentration for both Exendin-(9-39) doses were compared with the peak glucagon-like peptide-1 during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||pmol/l||Standard Error|Mean
64769|NCT01162499|Secondary|Mean Acetaminophen Plasma Concentration Area Under the Curve (AUC 0-3h)|The effect of gastric emptying was examined using the acetaminophen method whereby acetaminophen (30mg/kg or maximum of 1500mg) was mixed into the Pediasure/formula during the meal tolerance testing. Blood samples were collected every 30 minutes and the absorption of acetaminophen was determined by the gastric emptying rate, as the serum concentrations correlate with gastric emptying of liquids. Mean acetaminophen levels for each group at each time point were used to calculate the Area Under the Concentration versus Time Curve (AUC expressed in μg*min/l) after the consumption of formula for each of the two Exendin-(9-39) dose levels and normal saline vehicle.|3 hours|AUC were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||μg*min/l||Standard Error|Mean
64770|NCT01162499|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||pmol*min/l||Standard Error|Mean
64771|NCT01162499|Primary|Mean Plasma Glucose Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma glucose levels samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).||mg*min/dl||Standard Error|Mean
64772|NCT01162473|Primary|Number of Subjects Who Completed Desensitization Protocol|"Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be treatment failures. Subjects who completed the desensitization protocol were considered to be treatment successes."|1 year|The analysis population included all subjects who began desensitization per protocol.||participants|||Number
64773|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.||Canadian dollars||Standard Deviation|Mean
64774|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.||Canadian dollars||Standard Deviation|Mean
64775|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=2, 3 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).||percentage of participants|||Number
64903|NCT01161407|Primary|Calcium Balance|Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).|2 weeks|||mg/d calcium||Standard Error|Least Squares Mean
64776|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=11, 10 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).||percentage of participants|||Number
64777|NCT01162421|Secondary|HCR: Medical Insurance at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l’assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L’indemnisation des victimes d’actes criminals (IVAC).|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=26, 26 is the number of participants who answered that they did have health insurance).||percentage of participants|||Number
64778|NCT01162421|Secondary|Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l’assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L’indemnisation des victimes d’actes criminals (IVAC).|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=25, 28 is the number of participants who answered that they did have health insurance).||percentage of participants|||Number
64779|NCT01162421|Secondary|Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24|"Participants measured their satisfaction with care by specifying their in response to the question How satisfied are you with the results of your RA treatment? on a 5-point Likert scale, from the following 5 answers: not satisfied, a little satisfied, moderately satisfied, well satisfied, very well satisfied. Scores range from 1 to 5, with higher scores indicating more satisfaction with their care."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64780|NCT01162421|Secondary|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64781|NCT01162421|Secondary|Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64782|NCT01162421|Secondary|Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state).|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||units on a scale||Standard Error|Least Squares Mean
64783|NCT01162421|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24|The WLQ was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||units on a scale||Standard Error|Least Squares Mean
64784|NCT01162421|Secondary|Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. The MCID was defined as a 3.56-unit decrease in FACIT-Fatigue Scale.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
86666|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)|4 weeks|||Micrograms||Standard Deviation|Mean
64785|NCT01162421|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64786|NCT01162421|Secondary|Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving HAQ < 0.5. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
64787|NCT01162421|Secondary|Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving MCID in HAQ, defined as a 0.22 unit decrease in HAQ. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
64788|NCT01162421|Secondary|Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24|HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64789|NCT01162421|Secondary|Percentage of Participants With Flare-Up After Remission by Month 24|Percentage of participants with a flare-up after remission by Month 24, defined as participants who reached remission (DAS28 < 2.6) but later had two consecutive visits with DAS28 ≥ 2.6 (based on observed cases only). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment.||percentage of participants|||Number
64790|NCT01162421|Secondary|Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Moderate EULAR Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and < 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or an improvement (decrease) in the DAS28 of ≥ 1.2 from Baseline and attainment of a DAS28 score of > 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
64791|NCT01162421|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of ≥ 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
64792|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) low disease activity was defined as DAS28(CRP) < 3.2. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
64936|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 2|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.||participants|||Number
64793|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) remission was defined as DAS28(CRP) < 2.6. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).||percentage of participants|||Number
64794|NCT01162421|Secondary|Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||units on a scale||Standard Error|Least Squares Mean
64795|NCT01162421|Secondary|Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24||Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.||mg/L||Standard Error|Least Squares Mean
64796|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how severe their pain had been in the previous week on a VAS from 0 (no pain) to 100 (pain as bad as it could be). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64797|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how they were doing with their RA on a VAS from 0 (very well) to 100 (very poorly). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64798|NCT01162421|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Physicians were asked to indicate the participant’s disease activity (independent of the participant's self assessment) on a visual analogue scale (VAS) from 0 (very good) to 100 (very bad). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||units on a scale||Standard Error|Least Squares Mean
64799|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||tender joints||Standard Error|Least Squares Mean
64800|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-68, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||tender joints||Standard Error|Least Squares Mean
64801|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||swollen joints||Standard Error|Least Squares Mean
64802|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-66, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.||swollen joints||Standard Error|Least Squares Mean
64803|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR70 responder if the following 3 criteria for improvement from Baseline are met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: -~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
64804|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR50 responder if the following 3 criteria for improvement from Baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
64805|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR20 responder if the following 3 criteria for improvement from Baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: -~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein [CRP])."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
64806|NCT01162421|Secondary|Percentage of Participants With Rapid Radiographic Progression at Month 12|Radiographic progression was defined as a change from Baseline in mTSS that is ≥ 5 units. The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug ith an assessment (nonresponder imputation).||percentage of participants|||Number
64807|NCT01162421|Secondary|Change From Baseline in mTSS at Months 6, 12 and 24|The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 12, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug; n=number of participants with an assessment at Baseline and given timepoint (observed cases).||units on a scale||Standard Error|Least Squares Mean
64808|NCT01162421|Secondary|Percentage of Participants With No Radiographic Progression at Month 6 and Month 24|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).||percentage of participants|||Number
64809|NCT01162421|Primary|Percentage of Participants With No Radiographic Progression at Month 12|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF): missing responses were imputed by carrying forward the last non-missing post-baseline observation.||percentage of participants|||Number
64810|NCT01162304|Secondary|Patient Global Impression of Change|This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.|Visits 4 and 6 the end of each of the two treatment periods|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
64811|NCT01162304|Secondary|Short Form Health Survey (SF-36)|It is a 36-item questionnaire designed to measure general health related quality of life.|Visits 2, 4 and 6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
64812|NCT01162304|Secondary|Hospital Anxiety and Depression Scale|The HADS will be administered to assess anxiety and depression.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
64937|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Day 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
64814|NCT01162304|Primary|Numerical Pain Rating Scale (NRS)|The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p < 0.05 level using a two-tailed test.|Daily|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.|||||
64815|NCT01162135|Primary|Rate of Positive PSADT Outcome|Proportion of patients at 6 months post-treatment with a PSADT >= 200% from baseline|6 months after treatment with digoxin|||participants|||Number
64816|NCT01162122|Secondary|Number of Subjects Reporting Solicited Adverse Events Following Vaccination|The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.|Day 1 through Day 7 post vaccination|Analysis was done on the safety set i.e all randomized subjects who received a study vaccination and provided postvaccination safety data.||participants|||Number
64817|NCT01162122|Secondary|All Cause Mortality Rate, Across Vaccine Groups|The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).||participants|||Number
64818|NCT01162122|Secondary|Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups|The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).||participants|||Number
64819|NCT01162122|Secondary|Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups|The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness) population.||participants|||Number
64820|NCT01162122|Secondary|Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups|The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.|Day 22 through Day 366 post vaccination|Analysis was done on the modified full analysis set (mFAS; effectiveness) population i.e all subjects in the randomized population who received a study vaccination but excluding those who received a non-study vaccine during the follow-up phase.||participants|||Number
64821|NCT01162122|Secondary|Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains|"The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset.||Percentage of subjects||95% Confidence Interval|Number
64822|NCT01162122|Secondary|Persistence of GMTs Against Homologous and Heterologous Strains|The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366.||Titers||95% Confidence Interval|Geometric Mean
64823|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS||Percentage of subjects||95% Confidence Interval|Number
64824|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on PPS.||Percentage of subjects||95% Confidence Interval|Number
64825|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.|Day 22 post vaccination|Analysis was done on FAS.||Titers||95% Confidence Interval|Geometric Mean
64826|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .|Day 22 post vaccination|Analysis was done on PPS.||Titers||95% Confidence Interval|Geometric Mean
64827|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on FAS.||Percentage of subjects||95% Confidence Interval|Number
64828|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
64829|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.||Ratio||95% Confidence Interval|Geometric Mean
64830|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
64831|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS population.||Titers||95% Confidence Interval|Geometric Mean
64832|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.||Percentage of subjects||95% Confidence Interval|Number
64833|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS|The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.||Titers||95% Confidence Interval|Geometric Mean
64834|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS||Ratio||95% Confidence Interval|Geometric Mean
64835|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
64836|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.||Percentage of subjects||95% Confidence Interval|Number
64837|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS.||Percentage of subjects||95% Confidence Interval|Number
64838|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)|The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22||Titers||95% Confidence Interval|Geometric Mean
64839|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.||Percentage of subjects||95% Confidence Interval|Number
64840|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.||Titers||95% Confidence Interval|Geometric Mean
64841|NCT01162122|Primary|Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV|Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.|Day 22 post vaccination|Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.||Titers||95% Confidence Interval|Geometric Mean
64844|NCT01161771|Secondary|Change From Baseline in Schirmer's Test at Month 3|Change from baseline in Schirmer’s Test result at month 3. The Schirmer’s Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Millimeters of Tears||Standard Deviation|Mean
64845|NCT01161771|Secondary|Change From Baseline in Tear Break-Up Time at Month 3|Change from baseline in tear break-up time (TBUT) at month 3. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Seconds||Standard Deviation|Mean
64846|NCT01161771|Secondary|Change From Baseline in Conjunctival Staining at Month 3|Change from baseline in conjunctival staining severity score at month 3. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0= no staining, 5= severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement)|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Scores on a Scale||Standard Deviation|Mean
64847|NCT01161771|Secondary|Change From Baseline in Corneal Staining at Month 3|Change from baseline in corneal staining at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A positive number change from baseline represents an increase in corneal staining (worsening of dry eye).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Scores on a Scale||Standard Deviation|Mean
64848|NCT01161771|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3|Change from baseline in OSDI total score at month 3. The OSDI is a 12-question survey for subjects to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Scores on a Scale||Standard Deviation|Mean
64849|NCT01161771|Primary|The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured|The percentage of subjects at month 3 with corneal sensitivity < 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.|Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.||Percentage of Subjects|||Number
64850|NCT01161628|Secondary|Incidence of Non-relapse Mortality||2 years|||percentage of patients|||Number
64851|NCT01161628|Secondary|Incidence of Disease-free Survival||2 years|Of the surviving patients at 2 years (82% of initial enrolled population)||percentage of patients|||Number
64852|NCT01161628|Secondary|Duration of Systemic Corticosteroid Use||2 years|Only 2 patients out of the 22 evaluable patients enrolled received steroids during the course of treatment for cGVHD. A total of 25 patients were enrolled; 3 patients were excluded from this analysis due to treatment failure.||days||Full Range|Median
64853|NCT01161628|Primary|Rate of Partial Response of cGVHD to Treatment||2 years|||percentage of patients|||Number
64854|NCT01161628|Primary|Rate of Overall Response of cGVHD to Treatment||2 years|||percentage of patients|||Number
64855|NCT01161628|Secondary|Incidence of Overall Survival||2 years|||percentage of patients|||Number
64856|NCT01161628|Secondary|Time to Immunosuppression Withdrawal||2 years|||days||Full Range|Median
64857|NCT01161628|Secondary|Requirement for Systemic Corticosteroid Use||2 years|20 out of the 25 patients enrolled received no corticosteroids at all during the course of treatment for cGVHD||participants|||Number
64858|NCT01161628|Primary|Rate of Complete Response of cGVHD to Treatment.||2 years|||percentage of patients|||Number
64859|NCT01161563|Secondary|Discomfort From Injection|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires.||units on a scale||95% Confidence Interval|Mean
64860|NCT01161563|Primary|Patient Bother From Injection Site Burning and/or Stinging|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.||units on a scale||95% Confidence Interval|Mean
64904|NCT01161329|Primary|Short Physical Performance Battery (SPPB)|Total score on the scale: 0-12 Points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.|Baseline, after 3, 6 months and after 1 year|||units on a scale||Standard Deviation|Mean
64861|NCT01161537|Secondary|Part B: Absolute Change From Baseline in in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Week 48|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."||units on a scale||Standard Deviation|Mean
64862|NCT01161537|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 48|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."||mmol/L||Standard Deviation|Mean
64863|NCT01161537|Secondary|Part B: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 48|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."||percent predicted of FEV1||Standard Deviation|Mean
64864|NCT01161537|Secondary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part B: Day 1 up to Week 48|Safety Set for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part B.||participants|||Number
64865|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Day 43|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||units on a scale||Standard Deviation|Mean
64866|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Sweat Chloride at Day 43|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||millimole per liter (mmol/L)||Standard Deviation|Mean
64867|NCT01161537|Secondary|Part A: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Day 43|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||percent predicted of FEV1||Standard Deviation|Mean
64868|NCT01161537|Secondary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part A: Day 1 up to Day 57|Safety Set for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A. Data was reported as per the intervention received (Placebo [Placebo Run in/Washout] or VX-770 [VX-770 Treatment]).||participants|||Number
64869|NCT01161537|Primary|Part B: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Week 48|Subjects were asked to inhale hyperpolarized 3 He gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid MRI was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B.||percentage of total lung volume||Standard Deviation|Mean
64870|NCT01161537|Primary|Part A: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Day 43|Subjects inhaled hyperpolarized helium-3 (3He) gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid magnetic resonance imaging (MRI) was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He-MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.||percentage of total lung volume||Standard Deviation|Mean
64871|NCT01161498|Secondary|Participants With N1-2 Disease at Baseline Requiring Neck Dissection|Participants with Baseline Nl or N2 disease (lymph node metastasis not more than 6 cm in greatest dimension) with persistent disease as determined at the post chemoradiotherapy assessment of response were to proceed to neck dissection as permitted by the institution no later than Week 22. Since this study terminated prematurely neck dissection data were not collected or analyzed.|Weeks 19 - 21||||||
64872|NCT01161498|Secondary|Disease-specific Survival|"Disease-specific survival is defined as the time from randomization to death of the patient due to the cancer under study.~Because this study was terminated with 5 participants enrolled, disease-specific survival was not analyzed."|Up to 5 years after chemoradiotherapy||||||
64873|NCT01161498|Secondary|Overall Survival|"Overall survival is defined as the time from randomization to death from any cause.~Because this study was terminated with 5 participants enrolled, overall survival was not analyzed."|Up to 5 years after chemoradiotherapy||||||
64874|NCT01161498|Secondary|Time to Any Failure|"Any failure is defined as disease progression at any site at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 participants enrolled, time to any failure was not analyzed."|Up to 27 months||||||
64875|NCT01161498|Secondary|Time to Distant Failure|"Distant failure is defined as disease progression at any site other than the head and neck area at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 participants enrolled, time to distant failure was not analyzed."|Up to 27 months||||||
64876|NCT01161498|Secondary|Time to Locoregional Failure|"Locoregional failure is defined as disease progression in the head and neck area at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 subjects enrolled, time to locoregional failure was not analyzed."|Up to 27 months||||||
64877|NCT01161498|Secondary|Pathologic Complete Response (mCR)|"Response to therapy was assessed histopathologically from biopsies taken at surgery for those participants who had surgery prior to Week 22.~If no viable tumor cells were identified in surgical specimens (where the patient had surgery) the patient was classified as having a pathological complete response (pCR), and if viable tumor cells were identified, the patient was classified as having an incomplete pathologic response.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the pathologic complete response rate was not calculated. Therefore a summary of participants with a pathologic complete response before the end of study is reported."|Up to Week 20|Randomized participants who had protocol-specified surgery||participants|||Number
64878|NCT01161498|Secondary|Metabolic Complete Response (mCR)|"Response to therapy was assessed using [(18)F] fluorodeoxyglucose positron emission tomography (FDG PET) imaging to detect metabolically active tumors.~Metabolic complete response (mCR) is defined as complete disappearance of FDG uptake attributable to tumor compared to baseline scan.~Partial metabolic response (mPR) is defined as a > 40% decrease in specific uptake compared to the initial value in over half of the lesions.~Disease progression (mPD) is defined as a specific uptake increase in any lesion, appearance of new lesions, or presence of extended areas of disease activity.~Stable metabolic response (mSD) is defined as a decrease in uptake < 40% of the initial value of over half the lesions.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the metabolic complete response rate was not calculated. Therefore a summary of metabolic response at end of study is reported."|End of study; the maximum time on study was 20 weeks.|All randomized participants||participants|||Number
64879|NCT01161498|Secondary|Clinical Objective Response (cOR)|"Tumor response was assessed by computed tomography (CT) scan according to a modified version of the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1). Objective response is defined as achieving a clinical partial response (cPR) or complete response (cCR). cCR is defined as disappearance of all baseline lesions. Any pathological lymph nodes must have a reduction in short axis to < 10 mm. cPR is defined as at least a 30% decrease in the sum of diameters of baseline lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of baseline lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of any new lesions.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the cOR rate was not calculated. Therefore a summary of response at the end of study is reported."|End of trial; the maximum time on study was 20 weeks.|All randomized participants||participants|||Number
64880|NCT01161498|Primary|2-year Event-free Survival|Event-free survival is defined as the time from randomization until the first evidence of relapse, disease progression (local, regional, metastatic, or second primary), or death from any cause. Because this study was terminated with only 5 participants enrolled, and the study was terminated in the first year, this endpoint was not analyzed.|2 years||||||
64881|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT) on Day 6|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Words Recalled||Standard Error|Least Squares Mean
64882|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT)|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Words Recalled||Standard Deviation|Mean
64883|NCT01161472|Secondary|Change From Baseline in CogState Groton Maze Learning Task on Day 6|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Error|Least Squares Mean
64884|NCT01161472|Secondary|CogState Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Deviation|Mean
64885|NCT01161472|Secondary|Change From Baseline in CogState CPAL on Day 6|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Error|Least Squares Mean
64886|NCT01161472|Secondary|CogState Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Errors||Standard Deviation|Mean
64887|NCT01161472|Secondary|Change From Baseline in CogState One Card Learning on Day 6|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Arcsine [(sqrt) proportion correct]||Standard Error|Least Squares Mean
64888|NCT01161472|Secondary|CogState One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Arcsine [(sqrt) proportion correct]||Standard Deviation|Mean
64889|NCT01161472|Secondary|Change From Baseline in CogState Identification Speed on Day 6|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Error|Least Squares Mean
64905|NCT01161329|Primary|The Berg Balance Scale (BBS)|Total score on the scale: 0-56 Points. Higher scores indicates better balance.|baseline, after 3, 6 months and after 1 year|||units on a scale||Standard Deviation|Mean
64938|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 12|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.||participants|||Number
64890|NCT01161472|Secondary|CogState Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Deviation|Mean
64891|NCT01161472|Primary|Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Error|Least Squares Mean
64892|NCT01161472|Primary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline|The Per Protocol (PP) Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.||Log10 MS||Standard Deviation|Mean
64893|NCT01161420|Secondary|Percentage Sleep Time at SaO2 < 90%|"The percentage of time spent with oxygen saturation below 90% has been an increasingly utilized surrogate for morbidity risk in sleep apnea populations.~The SaO2 secondary endpoint in this study was determined by the time below an SaO2 level of 90% during the 12-month PSG study compared to that at baseline (average of screening and 1-month PSG studies). The objective was to demonstrate a decrease in the percentage of sleep time with an SaO2 level below 90% at 12 months."|12 months|||Percentage of Sleep Time SaO2 <90%||95% Confidence Interval|Mean
64894|NCT01161420|Secondary|Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months|The Epworth Sleepiness Scale (ESS) is a validated instrument that rates a subject’s daytime sleepiness. Like the FOSQ, it is a quality of life measure that is commonly used in clinical evaluation and management of OSA. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS score of less than 10 is considered to be the cutpoint for normal subjective sleepiness.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
64895|NCT01161420|Secondary|Change in FOSQ From Baseline to 12 Months|The Functional Outcomes Sleep Questionnaire (FOSQ) is a validated instrument that assesses the effect of a subject’s daytime sleepiness on activities of ordinary living. It is a quality of life measure that is commonly used in the clinical evaluation and management of OSA. This self-administered instrument consists of 30 questions divided into 5 domains: activity level, vigilance, intimacy, general productivity and social outcome. Scores range from 5 to 20, with higher scores indicating greater functioning. Change in FOSQ was calculated by subtracting the baseline score from the 12-month score.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
64896|NCT01161420|Secondary|Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects|"The intent-to-treat (ITT) analysis for the primary endpoint included all patients who underwent an implant. A modified ITT analysis was conducted to include the subjects who did not completed the 12-month follow-up sleep study also. The ITT analysis was to calculate the AHI responder rate based on the subjects included in the analysis as described below. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at their last visit.~The following subjects were included:~All implanted subjects who had AHI data collected at both baseline and 12-months follow-up.~All implanted subjects who had baseline data but no 12-month data, and had their last data values carried forward, provide they had a least 6-month AHI data.~Any implanted subject who did not have 12-month data available due to therapy failure (e.g., study withdrawal will be included in the analsys as a treatment failure."|12 months|Implanted subjects||Number of subjects responding to therapy|||Number
64897|NCT01161420|Secondary|AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study|The AHI difference between the 12-month PSG study and the 13-Month PSG study in the therapy maintenance group will be compared to the AHI difference in the therapy withdrawal group. The objective was to demonstrate that AHI increase in the therapy withdrawal group (therapy=OFF) is greater than any AHI change in the active therapy group (therapy=ON). AHI is the number of apneas or hypopneas recorded during a sleep study per hour of sleep; this is calculated by dividing the number of AHI events by the number of hours of sleep.|12 Months|The first 46 responders to the Inspire therapy at 12 months were randomized 1:1 to either the Therapy Maintenance Group (ON) or the Therapy Withdrawal Group (OFF). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups.||events per hour||95% Confidence Interval|Mean
64898|NCT01161420|Primary|Safety|The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.|12 months|||Events Reported|||Number
64899|NCT01161420|Primary|Oxygen Desaturation Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.|12 months|||percentage of subjects responding|||Number
64900|NCT01161420|Primary|Apnea Hypopnea Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.|12 months|||percentage of subjects responding|||Number
64906|NCT01161225|Secondary|Health Care Utilization Events|Participants report the following information for the prior 3-month period; their emergency department visits for asthma; hospitalization for asthma; urgent office visit for worsening asthma; routine office visit; specialist visit. A cumulative number of events were computed by adding # of visits and # of days (for hospitalization) occurred in the past 3 months .|9-months postcamp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||average number of events||Standard Deviation|Mean
64907|NCT01161225|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|Maximal amount of air one can forcefully exhale in one second. It is then converted to a percentage of normal. Range: 55-124 for the current sample.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed spirometry at 9-months assessment.||percentage of predicted FEV1||Standard Deviation|Mean
64908|NCT01161225|Secondary|Asthma Knowledge Questionnaire|This 30-item instrument was developed to measure children’s knowledge on triggers and symptom identifications, and asthma management procedures (i.e., what to do and how to do it) in a true/false format. Total scores (range: 14-30) were computed by summing the number of items correctly answered. The higher scores indicate greater knowledge levels.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
64909|NCT01161225|Secondary|Attitude Toward Illness Scale|This 13-item scale was designed to assess children’s attitude toward their health condition. The scale includes questions such as “how good or bad do you feel it is that you have ___?” and, “how often do you feel that your ___ is your fault?” Respondents answer each question on a 5-point Likert-type scale (1-5). Total summed scores (range: 25-65) was constructed to reflect respondents’ overall attitudes. Higher scores indicated positive attitudes.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
64910|NCT01161225|Secondary|Illness Management Survey|This 29-item scale was developed to assess perception of barriers and to predict risk for poor self-management in adolescents with chronic illness. This scale categorizes barriers based on internal processes (e.g., cognitive skills, denial, pessimistic thinking) and contextual forces (e.g., illness-related factors, peer/family influences). Total summed scores were computed (range: 28-91). Higher scores indicate the high levels of perceived barriers to self-management.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
64911|NCT01161225|Secondary|Asthma Self-Efficacy|This 14-item scale was developed to measure the child’s confidence in attack prevention (e.g., learn asthma self-management skills, correct use of medication) and attack management (e.g., control symptoms, decide which medication to use). Total summed scores were computed (range: 21-70). Higher total scores indicate greater degree of self-efficacy.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
64912|NCT01161225|Primary|Asthma Control Questions|This measure assesses the frequencies of the limitation of daily activity, asthma symptoms (daytime and nighttime) and use of rescue medication in the past 4 weeks on a 5-point scale (0-4). Total summed scores were computed (range: 4-16). Higher total scores indicate better controlled asthma.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
64913|NCT01161225|Primary|Pediatric Asthma Quality of Life Questionnaire (PAQLQ)|Twenty-three items cover problems identified as being most important and troublesome in children’s everyday lives due to asthma. This scale is effective in evaluating and discriminating because of its high sensitivity to changes in asthma status within and between individuals with varying severity of asthma. Respondents are asked to recall impairments experienced during the previous week. The scale consists of three subdomains including symptoms (10 items), emotional function (8 items) and activity limitation (5 items). Each item was measured on a 7-point scale; 1 indicates maximum impairment, and 7 indicates no impairment. Higher total scores indicate better levels of functioning. Total scores were computed by summing responses from all items (range:24-161)|9 months post camp|The number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.||units on a scale||Standard Deviation|Mean
64914|NCT01161173|Secondary|Percentage of Participants Who Developed Rash|At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.||Percentage of participants||95% Confidence Interval|Number
64915|NCT01161173|Secondary|Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores|Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with LCSS scores were included in the analysis.||Units on a scale||95% Confidence Interval|Mean
64916|NCT01161173|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until or death from any cause|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.||Months||95% Confidence Interval|Median
97596|NCT00835185|Secondary|t1/2 at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour post dose|Zero participants were analyzed, t1/2 results were not collected.|||||
64917|NCT01161173|Secondary|Progression-free Survival|Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Months||95% Confidence Interval|Median
64918|NCT01161173|Secondary|Time to Disease Progression|The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Months||95% Confidence Interval|Median
64919|NCT01161173|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was “confirmed” if a subsequent RECIST evaluation also showed a CR or PR.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
64920|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|24 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
64921|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|12 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
64922|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|8 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
64923|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|3 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
64924|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|3 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
64925|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|1.5 hours after cream application|||Fluorescence intensity unit||95% Confidence Interval|Mean
64926|NCT01160822|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.||mL||Standard Deviation|Mean
64927|NCT01160822|Secondary|Apparent Clearance of Canakinumab From Plasma (CL/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.||mL/hr||Standard Deviation|Mean
64928|NCT01160822|Secondary|Terminal Phase Half-life (t1/2) of Canakinumab|The time it takes for the concentration level of canakinumab to fall to 50% of the original value.|Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||hours||Standard Deviation|Mean
64929|NCT01160822|Secondary|Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||µg*day/mL||Standard Deviation|Mean
64930|NCT01160822|Secondary|Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||µg*day/mL||Standard Deviation|Mean
64931|NCT01160822|Secondary|Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||hours||Full Range|Median
64932|NCT01160822|Secondary|Maximum Observed Plasma Concentration of Canakinumab (Cmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.||µg/mL||Standard Deviation|Mean
64933|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 12|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.||participants|||Number
64934|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 8|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.||participants|||Number
64941|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 2|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.||participants|||Number
64942|NCT01160822|Secondary|Patient’s Global Assessment of Response to Treatment on Day 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.||participants|||Number
64943|NCT01160822|Secondary|Part B: Proportion of Participants Who Used Rescue Analgesic During Study|Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication.|Day 4, Weeks 1, 2, 4, 8 and 12|Safety analysis set (all participants as assigned that received at least one dose of study drug).||proportion of participants|||Number
64944|NCT01160822|Secondary|Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales|"The WOMAC consists of 3 subscales:~The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.~The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.~The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.~Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.||units on a scale||Standard Deviation|Mean
64945|NCT01160822|Secondary|Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)|A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).|Baseline, Day 4, Weeks 1, 2, 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data. N is the number of participants with available data at each time point.||percentage of participants|||Number
64946|NCT01160822|Secondary|Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).~Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.||units on a scale||Standard Deviation|Mean
64947|NCT01160822|Primary|Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale|"The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.~Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Week 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.||units on a scale||Standard Deviation|Mean
64948|NCT01160822|Primary|Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.~Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects."|Baseline and Day 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.||units on a scale||Standard Deviation|Mean
64949|NCT01160822|Primary|Part A: Number of Participants With Intolerance Events|An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection.|Baseline to Day 3|Safety analysis set.||participants|||Number
64950|NCT01160770|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms|"The parent/caregiver was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36|||percentage of participants|||Number
64951|NCT01160770|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms|"The physician was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36|||percentage of participants|||Number
97738|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
64952|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36|||percentage of participants|||Number
64953|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36|||percentage of participants|||Number
64954|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36|||percentage of drop seizures||Full Range|Median
64955|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36|||percentage of drop seizures||Full Range|Median
64956|NCT01160744|Secondary|Squamous Population OS|OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Randomization to the date of death from any cause [up to end of study (November 2015)]||11/2016||||
64957|NCT01160744|Other Pre-specified|Change in Tumor Size (CTS)|CTS was defined as the log ratio of tumor size at 6 weeks to tumor size at baseline. CTS at 6 weeks=Log (Sum of Target Lesion Measurements at 6 Weeks)-Log (Sum of Target Lesion Measurements at Baseline).|Baseline, 6 weeks|All randomized participants with results at baseline and 6 weeks.||log ratio||Standard Deviation|Mean
64958|NCT01160744|Other Pre-specified|Percentage of Participants With CR, PR, or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.||percentage of participants||90% Confidence Interval|Number
64959|NCT01160744|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Who Died|Data presented are the number of participants with at least 1 treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (SAE), as well as, the number of participants who died during the study. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). A summary of SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Day 1, Cycle 1 (3-week cycles) up to 89 weeks of treatment and 1 month post-treatment follow-up|All randomized participants who received at least 1 dose of study drug.||participants|||Number
64960|NCT01160744|Secondary|Duration of Response (DOR)|DOR was measured from the time criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death. Response was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker level of non-target lesions. PR was defined as ≥30% decrease SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Time of first response (CR or PR) until PD or death (up to 24 months)|All randomized participants with a best overall response of CR or PR. Participants censored: Pem+Carb/Cis=44, Ram+Pem+Carb/Cis=35, Gem+Carb/Cis=50, Ram+Gem+Carb/Cis=37.||months||90% Confidence Interval|Median
64961|NCT01160744|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Randomization to the date of death from any cause (up to 31.3 months)|ITT Population: All randomized participants. Participants censored: Pem+Carb/Cis=22, Ram+Pem+Carb/Cis=16, Gem+Carb/Cis=32, Ram+Gem+Carb/Cis=32.||months||90% Confidence Interval|Median
64962|NCT01160744|Secondary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.||percentage of participants|||Number
64981|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng*h/mL||Standard Deviation|Mean
66933|NCT01138150|Secondary|High Molecular Weight (HMW)-Adiponectin (ADP)|serum HMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
64963|NCT01160744|Primary|Progression-Free Survival (PFS)|PFS was the time from randomization to the first objective progression as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1) or death from any cause, whichever occurred first. Progressive disease (PD) was defined as ≥20% increase in sum of diameter (SOD) of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 millimeters (mm); appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants alive and without disease progression were censored at the time of the last objective tumor assessment. Participants who did not progress and were lost to follow-up were censored at their last radiographic assessment. If no baseline or post baseline radiologic assessments were available, participants were censored at date of randomization.|Randomization to PD or death (up to 24 months)|Intent-to-Treat (ITT) Population: All randomized participants. Participants censored: Pem+Carb/Cis=14, Ram+Pem+Carb/Cis=13, Gem+Carb/Cis=14, Ram+Gem+Carb/Cis=18.||months||90% Confidence Interval|Median
64964|NCT01160640|Secondary|Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.|Identification of endometrial microorganisms present obtained from women with or without evidence of endometritis using a combination of culture methods, rRna sequencing and whole genomic sequencing. The aim is to identify the etiology of endometritis.|enrollment|Women who had an endometrial sample that was sufficient for histologic assessment for endometritis.||participants|||Number
64965|NCT01160640|Secondary|Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis|Clinical response to treatment is improvement (reduction) of the McCormack Scale total score from baseline to day 3 follow-up visit. Participants without a 3-day measure were considered treatment failures.|Enrollment to 3 day follow up visit|||participants|||Number
64966|NCT01160640|Secondary|The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.|M. genitalium not detected in the cervical and endometrial cultures by nucleic acid amplification testing at the 30 day visit among women who had M. genitalium detected at either anatomical site at the enrollment visit.|Enrollment to 30 days|There were 34 women who had M. genitalium detected in the cervix or endometrium at enrollment who had test results from the 30-day visit.||participants|||Number
64967|NCT01160640|Secondary|The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.|The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.|enrollment|||participants|||Number
64968|NCT01160640|Primary|Clearance of Anaerobic Organisms From the Endometrium|Clearance of anaerobic microorganisms from the endometrium at the 30 day follow-up visit among women who had anaerobic microorganisms detected in their endometrial tissue sample at enrollment. Clearance is defined as no anaerobic microorganisms detected in the endometrial tissue biopsy sample collected at the 30-day visit.|Enrollment to 30 days|Women who had anaerobic microorganisms detected in their endometrial biopsy sample at enrollment based on standard bacterial culture techniques.||participants|||Number
64969|NCT01160614|Primary|The Number of Patients With Adverse Events as a Measure of Safety||Adverse events (AEs) & serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion (AEs) & through 30 days following last study drug dose, or until last study visit, whichever was later (SAEs).|The safety population (N = 30) was defined as the group of patients who received study drug||participants|||Number
64970|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Lag Time Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value From Hour 0 to 12 Hours of the First Dose of ORF (Tlag 0-12)|Due to insufficient sampling, tlag 0-12 was not estimated.|Up to 12 hours||||||
64971|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Time to Maximum Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Tmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||h||Full Range|Median
64972|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Maximum Observed Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Cmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng/mL||Standard Deviation|Mean
64973|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Mean Area Under the Plasma Concentration During Each Dosing Interval-time Curve From Hour 0 to 12 Hours of the First Dose of ORF (AUC 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng*h/mL||Standard Deviation|Mean
64974|NCT01160614|Primary|Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)|Due to insufficient sampling, tlag was not estimated.|Up to 24 hours||||||
64975|NCT01160614|Primary|Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)|Due to insufficient sampling, t1/2z was not estimated.|Up to 24 hours||||||
64976|NCT01160614|Primary|Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)|Due to insufficient sampling, Lamda z was not estimated.|Up to 24 hours||||||
64977|NCT01160614|Primary|Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||hour (h)||Full Range|Median
64978|NCT01160614|Primary|Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng/mL||Standard Deviation|Mean
64979|NCT01160614|Secondary|Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)||Up to 72 hours if all 5 doses were administered|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric||ng/mL||Standard Deviation|Mean
64980|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)|Due to insufficient sampling, AUCinf was not estimated.|Up to 24 hours||||||
64982|NCT01160484|Secondary|Follow-up Time|time that patients were monitored for disease progression and overall survival|Follow-up visits for disease progression and overall survival every 3 months after study discontinuation. After progression, follow-up visits for survival status every 6 months or until alternate therapy needs to be started or death intervenes|||months||Full Range|Median
64983|NCT01160484|Secondary|Progression-free Survival||Time from the start of treatment to progressive disease or until death|||months||Full Range|Median
64984|NCT01160484|Secondary|Time to Progression||Time from the start of treatment to progressive disease|||months||Full Range|Median
64985|NCT01160484|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|||months||Full Range|Median
64986|NCT01160484|Secondary|Time to Best Response||Up to 7.5 months (eight 28-day cycles)|||months||Full Range|Median
64987|NCT01160484|Secondary|Time to First Response||Up to 7.5 months (eight 28-day cycles)|||months||Full Range|Median
64988|NCT01160484|Primary|International Myeloma Working Group (IMWG) Response Criteria|The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.|Up to 7.5 months (eight 28-day cycles)|Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria [complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)]||participants|||Number
64989|NCT01160458|Secondary|Safety of IMC-A12 in Patients With Mesothelioma|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|36 months|||Participants|||Number
64990|NCT01160458|Primary|Clinical Response Rate (PR+CR)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|36 months|||Participants|||Number
64991|NCT01160445|Secondary|Toxicity of Zanolimumab and IL-2 Treatment Regimen|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10 months|||Participants|||Number
64992|NCT01160445|Primary|The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.|Tumor regression was assessed by the Response Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% in the sum of the longest diameter (LD) recorded since the treatment started. Stable disease (SD) is neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|2 years|||Participants|||Number
64993|NCT01160380|Secondary|Epworth Sleepiness Scale (ESS) Score|Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness|Day 1, Day 28 and Day 56|||units on a scale||Standard Deviation|Mean
64994|NCT01160380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.|Day 1, Day 28 and Day 56|||units on a scale||Standard Error|Mean
64995|NCT01160380|Secondary|Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score|Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).|Day 1, Day 28 and Day 56|||units on a scale||Standard Deviation|Mean
64996|NCT01160380|Primary|Digit Span Test Score|Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.|Day 1, Day 28 and Day 56|||Number of correct items||Standard Deviation|Mean
64997|NCT01160380|Primary|Symbol Digit Modalities Test Score (SDMT)|Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance|Day 1, Day 28 and Day 56|||Number of correct matches||Standard Deviation|Mean
64998|NCT01160380|Primary|Trail Making Test B Score (TMT-B)|"Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.~The test evaluates the time to correctly order letters and numbers; low times = better performance."|Day 1, Day 28 and Day 56|||seconds||Standard Deviation|Mean
64999|NCT01160380|Primary|BFI Score|Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10|Day 1, Day 28 and Day 56|||units on a scale||Standard Deviation|Mean
65000|NCT01160237|Secondary|Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years||At Days 0, 7 and 182|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
65001|NCT01160237|Secondary|Potential Immune Mediated Diseases||During the whole study period (Day 0 - Day 182)|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
65002|NCT01160237|Secondary|Number of Subjects Reporting Serious Adverse Events||During the whole study period (Day 0 - Day 182)|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.||subjects|||Number
65003|NCT01160237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||During 31 days (Day 0 - Day 30) after vaccination|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.||subjects|||Number
65004|NCT01160237|Secondary|Solicited Local and General Symptoms||During 7 days (Day 0 - Day 6) after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
65005|NCT01160237|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years||21 days after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.|||||
65006|NCT01159938|Secondary|Change in Postprandial Pulse Wave Velocity (PWV)|The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and post-baseline PWV measurement at specified time point and no major protocol deviation.||meters per second (m/sec)||Standard Deviation|Mean
65007|NCT01159938|Secondary|Change in Blood Glucose (BG)|Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline blood glucose measurement at specified time point and no major protocol deviation.||millimoles per liter (mmol/L)||Standard Deviation|Mean
65008|NCT01159938|Secondary|Change in QT Interval on Electrocardiogram (ECG)|QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline QT interval measurement at specified time point and no major protocol deviation.||milliseconds (msec)||Standard Deviation|Mean
65009|NCT01159938|Secondary|Change in Peripheral Artery Tonometry (PAT)|The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)|Enrolled healthy and randomized T2DM participants who had a baseline and a post-baseline PAT measurement at specified time point and no major protocol deviation.||percentage of pulse amplitude||Standard Deviation|Mean
65010|NCT01159938|Secondary|Change in Pulse Wave Amplitude (PWA)|The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants with a baseline and a post-baseline PWA measurement at specified time point and no major protocol deviation.||percentage of systolic peak||Standard Deviation|Mean
65011|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|240 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
65012|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|180 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
65013|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|120 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
65014|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|60 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
65015|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|30 mins (pre-breakfast)|Randomized T2DM participants who were scheduled to receive study drug and had a baseline PWV measurement at the specified time point and no major protocol deviation.||meters per second (m/s)||95% Confidence Interval|Least Squares Mean
65016|NCT01159912|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the ages of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Error|Least Squares Mean
65017|NCT01159912|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
65018|NCT01159912|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
65019|NCT01159912|Secondary|Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough evening PEF is the PM PEF measured approximately 24 hours after the last evening administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
65020|NCT01159912|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
65021|NCT01159912|Primary|Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
65022|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied were you with olopatadine 0.2%? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 7|All subjects who used the study medication at least once (intent to treat).||Percentage of Participants|||Number
65023|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied are you with your current eye allergy medication? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 0|All subjects who used the study medication at least once (intent to treat).||Percentage of Participants|||Number
65024|NCT01159743|Secondary|Change Over Time in Body Fat Distribution|"Change over time in total body fat and fat in the limbs and trunk was assessed by dual X-ray absorptiometry (DEXA) in participants for whom a DEXA measurement performed at least 6 months before participation in this study was available.~A negative change score indicates fat loss over time and a positive change score indicates fat gain over time."|DEXA performed at the study visit and more than 6 months prior to the study visit (the period of time between the DEXA recorded at the study visit and the previous DEXA ranged from 6 to 36 months).|Participants for whom a dual X-ray absorptiometry measurement performed at least 6 months before participation in this study was available.||kg||Standard Deviation|Mean
65025|NCT01159743|Secondary|Lipodystrophy Severity Grading Scale (LSGS) Scores|"Perception of body fat was assessed by the Lipodystrophy Severity Grading Scale (LSGS), a standardized measurement of subjective lipoatrophy (fat loss) and lipoaccumulation (fat gain) perceived by the participant and by the physician. The degree of lipoatrophy and diffuse fat accumulation at each region was rated by both the participant and the physician as: Score 0=absent; Score 1=mild or noticeable on close inspection; Score 2=moderate or readily noticeable by patient/physician; Score 3=severe or readily noticeable to a casual observer.~Score A reflects the lipoatrophy or fat loss perception at the face, arms, buttocks and legs and ranges from 0-12.~Score B reflects the perception of fat gain at the abdomen, neck, and breasts and ranges from 0-9.~The overall score is the sum of the scores A+B, and ranges from 0-21.~Higher numbers indicate more fat loss (Score A) or gain (Score B). An average overall patient/physician score >7 indicates a clinical diagnosis of lipodystrophy."|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each score for each group of participants is shown as N (EFV and then LPV/r)."||units on a scale||Standard Deviation|Mean
65026|NCT01159743|Secondary|Distribution of Body Fat Mass|Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each category for each group of participants is shown as N (EFV and then LPV/r)."||kg||Standard Deviation|Mean
65027|NCT01159743|Primary|Total Limb Fat Mass|Total limb fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan. DEXA uses a whole body scanner and two different low-dose x-rays to read bone mass and soft tissue mass.|Study visit|All participants for whom data were available.||kg||Standard Deviation|Mean
65028|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3|"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied."|At Visit 3 (after approximately 6 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.||participants|||Number
65029|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2|"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied."|At Visit 2 (after approximately 2-4 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.||participants|||Number
65030|NCT01159691|Primary|Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints|"Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day).~For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 – 12).~Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 – 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement."|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.||units on a scale||Standard Deviation|Mean
65031|NCT01159691|Primary|Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)|Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.||millimeter (mm)||Standard Deviation|Mean
65032|NCT01159665|Other Pre-specified|Time Necessary to Remove the Vitreous From the Eye|PPV was performed in all subjects. The time necessary to remove the vitreous from the eye, measured from first start of vitrectomy cutter till end of core vitrectomy phase, was calculated.|From first start of vitrectomy cutter till the end of core vitrectomy phase|Safety Set||Minutes||Standard Deviation|Mean
65051|NCT01159262|Secondary|Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion||During Study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.||percentage of subjects|||Number
65052|NCT01159262|Primary|Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion||During study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.||percentage of subjects|||Number
65033|NCT01159665|Primary|Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.|Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 [5-30 minutes]; Group 2 [31-60 minutes]; Group 3 [2-4 hours]; Group 4 [24 hours ±2 hours]; Group 5 [7 days ±1 day]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.|5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection|Safety Set. Values for the PPV 7 days (+1 day) after injection and for PPV without injection treatment groups were all < Lower Limit of Quantification (LLOQ)||ng/mL||Standard Deviation|Mean
65034|NCT01159600|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic events, as reported as adverse events.|From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days|"Treated set, which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.~Open label set which included all patients entered into the open-label arm."||percentage of participants|||Number
65035|NCT01159600|Primary|HbA1c Change From Baseline|"Change from baseline in HbA1c after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||percentage of HbA1c||Standard Error|Mean
65036|NCT01159600|Secondary|Mean Daily Plasma Glucose (MDG) Change From Baseline|"Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||mg/dL||Standard Error|Mean
65037|NCT01159600|Secondary|Body Weight Change From Baseline|"Body weight change from baseline after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."||kg||Standard Error|Mean
65038|NCT01159535|Primary|Mean Number of Alcohol and Drug Use Days Out of Past 30|Self reported use of alcohol and or illicit substances over the previous 30 days|30 days previous, assessed at 12-month follow-up|||number of days out of past 30||Standard Deviation|Mean
65039|NCT01159431|Secondary|Mood|Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of > 25 consistent with severe depression.|18-weeks|||units on a scale||Standard Deviation|Mean
65040|NCT01159431|Primary|Change in Seizure Frequency|Percent change in seizure frequency from baseline|18 weeks|||percentage change in seizures per month||Standard Deviation|Median
65041|NCT01159431|Secondary|Response Ratio: Mean Percent Change in Seizures|Response Ratio: Mean Percent Change in seizures over the treatment period, where [T-B] / [T+B] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.|18 weeks|||percentage change of RRATIO||Standard Deviation|Mean
65042|NCT01159431|Primary|Time to the 4th Seizure|Number of Days to the 4th seizure|treatment period (18-weeks)|||days||Standard Deviation|Mean
65043|NCT01159431|Primary|50% Responder Rate|"Change in responder rate, at end of study (18 weeks)~Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage."|Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks|||percentage of participants|||Number
65044|NCT01159262|Secondary|Time to Successful Extubation in DEX-exposed Subjects||From start of DEX administration to extubation of each subject up to 7 days post-infusion|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.||hour||95% Confidence Interval|Median
65045|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion||milligram/Kg||Standard Deviation|Mean
65046|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion||microgram/Kg||Standard Deviation|Mean
65047|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion||milligrams/Kg||Standard Deviation|Mean
65048|NCT01159262|Secondary|Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion||milligram||Standard Deviation|Mean
65049|NCT01159262|Secondary|Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion||Microgram||Standard Deviation|Mean
65050|NCT01159262|Secondary|Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During Study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion||Milligram||Standard Deviation|Mean
65053|NCT01159171|Secondary|Overall Survival|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population||months||Standard Deviation|Mean
65054|NCT01159171|Secondary|Overall Survival (OS) - Percentage of Participants With an Event by 24 Months|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.|Baseline, monthly to end of study (up to 24 months)|ITT Population||percentage of participants|||Number
65055|NCT01159171|Secondary|Time to Progression|TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population||months||Standard Deviation|Mean
65056|NCT01159171|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months|TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.|Baseline, monthly to end of study (up to 24 months)|ITT Population||percentage of participants|||Number
65057|NCT01159171|Secondary|Time to Treatment Failure|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population||months||Standard Deviation|Mean
65058|NCT01159171|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every month to end of treatment (up to 24 months)|ITT Population||percentage of participants|||Number
65059|NCT01159171|Secondary|Duration of Stable Disease|Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population: only participants with a best overall response of CR, PR, or SD were included in the analysis.||months||Standard Deviation|Mean
65060|NCT01159171|Primary|Percentage of Participants by Best Overall Response|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population. 5 participants were not assessed as they did not reach the 3 month time-point.||percentage of participants|||Number
65061|NCT01159171|Secondary|Duration of Stable Disease - Percentage of Participants With an Event by 24 Months|Duration of stable response (CR, PR, or stable disease [SD]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR, PR, or SD were included in the analysis.||percentage of participants|||Number
65062|NCT01159171|Secondary|Duration of Response|Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.||months||Standard Deviation|Mean
65063|NCT01159171|Secondary|Duration of Response - Percentage of Participants With an Event by 24 Months|Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT population; only participants with a best overall response of CR or PR were included in the analysis.||percentage of participants|||Number
97739|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
65064|NCT01159171|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|Intent to Treat (ITT) Population: all participants who signed the informed consent, were assigned a study patient number, and who were administered at least 1 dose of 1 study medication.||percentage of participants|||Number
65065|NCT01158924|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population||units on a scale||Standard Deviation|Mean
65066|NCT01158924|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
65067|NCT01158924|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population||participants|||Number
65068|NCT01158924|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
65069|NCT01158924|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~The Neurological Assessment at 12 months was only conducted on 13 subjects from the 1.0mg group (out of 14 total subjects) and 25 subjects from the 2.0 mg group (out of 26 total)."||participants|||Number
65070|NCT01158716|Secondary|ECG Evidence of Ischemia During Coronary Balloon Occlusion|ST-segment deviation as monitored during coronary balloon occlusion|During coronary balloon occlusion||||||
65071|NCT01158716|Secondary|Chest Pain During Coronary Balloon Occlusion|Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)|During coronary balloon occlusion||||||
65072|NCT01158716|Primary|Delta Cardiac Troponin I (ΔcTnI)|ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography|24 hours post PCI|||ng/mL||Inter-Quartile Range|Median
65073|NCT01158703|Secondary|Number of Thrombotic Events|Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants||thrombotic Events over 52Wks|||Number
65074|NCT01158703|Secondary|Number of Myocardial Infarction Events|Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants||MI Events over 52Wks|||Number
65075|NCT01158703|Secondary|Number of Angina Events|Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants||Angina Events over 52Wks|||Number
65076|NCT01158703|Secondary|Number of Major Adverse Cardiovascular Events With Combination Therapy|Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of all events reported||MACE Events over 52Wks|Participants||Number
65077|NCT01158703|Secondary|Incidence of Bleeding Between the Two Treatment Arms||52 weeks|||BLEEDING EVENTS|||Number
65078|NCT01158703|Primary|Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo|52 weeks|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo||occluded grafts|Participants||Number
65079|NCT01158534|Secondary|Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months|To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.|at two months from start of treatment|Patients that received treatment||participants|||Number
65080|NCT01158534|Secondary|Progression-free Survival|Progression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.|to progression|||months||95% Confidence Interval|Median
65862|NCT01151761|Secondary|Overall Survival at 12 Months|the estimated probability for the percentage of participants with overall survival at 12 months.|12 months|There were only two patients analyzed. Please take that under advisement when looking at the results.||probability|||Number
65081|NCT01158534|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.|end of study|Patients who achieved at least a partial response||months||Full Range|Median
65082|NCT01158534|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method.|death|||months||95% Confidence Interval|Median
65083|NCT01158534|Primary|Objective Response Rate Assessed by RECIST Criteria.|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.|at week 4 of cycle 2 and every other cycle thereafter|||participants|||Number
65084|NCT01158378|Secondary|Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.|Device-related surgical wound infections included all infections classified by the CEC as definitely, probably, possibly or undetermined in relation to the device.|120 days|Includes all subjects with available data that through 120 days follow-up.||percentage of subjects|||Number
65085|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 45 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|45 days|All subjects who received treatment with evaluable 45-day follow-up data.||percentage of subjects||95% Confidence Interval|Number
65086|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 14 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|14 days|All subjects who received treatment with evaluable 14-day follow-up data.||percentage of subjects||95% Confidence Interval|Number
65087|NCT01158378|Primary|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|120 days|All subjects who received treatment with evaluable 120-day follow-up data.||percentage of subjects||95% Confidence Interval|Number
65088|NCT01158261|Primary|Specific Safety Parameters|"Incidence of graft occlusion~Incidence of adverse events potentially related to non-graft thrombotic events~Incidence of bleeding events"|Up to 4-weeks post-operatively|From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.||participants|||Number
65089|NCT01157845|Secondary|Liver Transplantation|Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation|1 year|||participants|||Number
65090|NCT01157845|Primary|Mortality From Liver Failure|Patient dies of liver-related causes within 1 year of study entry|1 year|||participants|||Number
65091|NCT01157533|Primary|Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose|Peak level (PK blood samples) drawn 4 hours after the completion of loading dose. Sequential trough levels drawn 30 minutes before each standard vancomycin dose for the next 4 doses. PK testing measures the amount of study drug in the body at different time points, with trough testing following 5 doses (1 dose every 8 to 12 hours).|Up to 5 days|Unable to complete analysis planned due to low enrollment.|||||
65179|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 – Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 – Post-treatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65092|NCT01156532|Secondary|Mean Dermatology Life Quality Index (DLQI) Score Over Time|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.||units on a scale||Standard Deviation|Mean
65093|NCT01156532|Secondary|Mean Psoriasis Area and Severity Index (PASI) Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.||units on a scale||Standard Deviation|Mean
65094|NCT01156532|Secondary|Adherence to Adalimumab Treatment|Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.|up to 16 weeks|Participants who received at least one dose of study treatment.||participants|||Number
65095|NCT01156532|Secondary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.|From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).|Participants who received at least one dose of study treatment.||participants|||Number
65096|NCT01156532|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16|EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.|Baseline, Week 16|Participants with available data.||units on a scale||Standard Deviation|Mean
65097|NCT01156532|Primary|Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data.||percentage of participants||95% Confidence Interval|Number
65098|NCT01156532|Primary|Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data. One participant was excluded from the analysis because only baseline and not follow-up information was available. Furthermore, 3 participants did not have their PASI measurement available either at baseline or at their last follow-up visit.||percentage of participants||95% Confidence Interval|Number
65099|NCT01156480|Secondary|Mortality||at 40 weeks corrected gestational age||||||
65100|NCT01156480|Secondary|Growth Velocity||at 40 weeks CGA||||||
65101|NCT01156480|Secondary|Length of Stay|this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA.|at 40 weeks corrected gestational age||||||
65102|NCT01156480|Secondary|Time to Full Enteral Feeds|this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA|at 40 weeks corrected gestational age||||||
65103|NCT01156480|Secondary|Time on Parenteral Nutrition||at 40 weeks corrected gestational age||||||
65104|NCT01156480|Secondary|Incidence of Sepsis||at 40 weeks corrected gestational age||||||
65105|NCT01156480|Secondary|Need for Gastrointestinal Surgery||at 36 weeks corrected gestational age||||||
65106|NCT01156480|Secondary|Spontaneous Intestinal Perforation||at 36 weeks corrected gestational age||||||
65107|NCT01156480|Secondary|Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)||36 weeks corrected gestational age||||||
65108|NCT01156480|Primary|CRP Level|C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC|7 days|||mg/L|||Number
65109|NCT01156480|Primary|CRP Level|C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.|3 days|||mg/L|||Number
65110|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65863|NCT01151761|Secondary|Serum CA 19-9 Levels|Initial level of Cancer antigen 19-9|12 months|||U/ml||Full Range|Mean
65111|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65112|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65113|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65114|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65115|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65116|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65117|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65118|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65119|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65120|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65121|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65217|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
65122|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65123|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65124|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65125|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65126|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65127|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65128|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65129|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65130|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65131|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65132|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65133|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65134|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65135|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65136|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65137|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65138|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65139|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65140|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65141|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65142|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65143|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65216|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65144|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65145|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65146|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65147|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65148|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65149|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65150|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65151|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65152|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65153|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65154|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65864|NCT01151761|Secondary|Pathologic Complete Response Rate|Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.|12 months|||participants|||Number
65155|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65156|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65157|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65158|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65159|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65160|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65161|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65162|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65163|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65164|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65165|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65166|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65167|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65168|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65169|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65170|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65171|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65172|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65173|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.||Percentage of Participants|||Number
65174|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 25|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65175|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 – Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 – Post-treatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65176|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 – Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 – Pretreatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65177|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 5|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65178|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 3|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65180|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 – Baseline/Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 – Baseline/Pretreatment|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65181|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Screening|Analysis was based on subjects with measurements for this variable.||Percentage of Participants|||Number
65182|NCT01156363|Secondary|Percentage of Participants Requiring Dose Adjustments|Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.|Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8|ITT population. Here, number of participants analyzed signifies participants who were evaluable for this outcome and n signifies participants who were evaluable for specified time-point.||percentage of participants|||Number
65183|NCT01156363|Secondary|Mean Time Participants Spent Having Hb Concentration Within Target Range|Target Hb concentration was between 10.0 and 12.0 g/dL.|Weeks 1 to 32|ITT Population.||days||Standard Deviation|Mean
65184|NCT01156363|Secondary|Change in Hb Concentration Between Reference and Treatment Period|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.||g/dL||Standard Deviation|Mean
65185|NCT01156363|Secondary|Mean Monthly Hb Values|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.||g/dL||Standard Deviation|Mean
65186|NCT01156363|Primary|Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range|Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.|Weeks 1 to 32|ITT Population.||percentage of participants|||Number
65187|NCT01156311|Other Pre-specified|Number of New or Newly Enlarging T2 Lesions|The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period.|Week -8 to Week 24|Number of participants in the Gd cohort with analyzable data in both Monotherapy and Add-on Therapy Periods. Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.||lesions per month||Standard Deviation|Mean
65188|NCT01156311|Other Pre-specified|Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans).|Week -4 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.||lesions||Standard Deviation|Mean
65189|NCT01156311|Other Pre-specified|Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging [MRI] scans).|Week -8 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.||lesions||Standard Deviation|Mean
65190|NCT01156311|Primary|Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy|Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy; n=participants in the safety population with at least 1 post-baseline value.||percentage of participants|||Number
65191|NCT01156311|Primary|Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy|Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3*ULN) concurrent with elevated total bilirubin was also evaluated.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.||percentage of participants|||Number
65192|NCT01156311|Primary|Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy|Percentage of participants with potentially clinically significant hematology laboratory abnormalities.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.||percentage of participants|||Number
65213|NCT01157234|Secondary|Estimated Glomerular Filtration Rate (ml/Minute) Change From Baseline to Month-12 Between the Groups|The changed percentage in Estimated Glomerular Filtration Rate (eGFR), (based on the Modification of Diet in Renal Disease Equation)=[Month-12 GFR level minus baseline eGFR level] divided by [baseline eGFR level] multiplied by 100, where all levels are in ml/min.|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||percent change||Standard Error|Least Squares Mean
65193|NCT01156311|Primary|Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.|AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.||percentage of participants|||Number
65194|NCT01156311|Other Pre-specified|Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period)|Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included.|from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0)|The Safety Population for the Monotherapy Period was defined as any participant who took at least 1 dose of background therapy.||percentage of participants|||Number
65195|NCT01157377|Primary|Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes|The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).|Baseline, Week 12|Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.||Episodes||Standard Deviation|Mean
65196|NCT01157351|Primary|Percentage of Participants in Each Event Category of First Treatment Failure|First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||percentage of participants|||Number
65197|NCT01157351|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration|The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Units on a scale||Standard Error|Least Squares Mean
65198|NCT01157351|Secondary|Time to First Psychiatric Hospitalization|A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the “Assessment of Treatment Failure – Psychiatric Hospitalization.”|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||Days||95% Confidence Interval|Median
65199|NCT01157351|Secondary|Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration|The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants’ degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||Units on a scale||Standard Error|Least Squares Mean
65214|NCT01157234|Primary|Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups.|Percent change in Nitric Oxide (NO) blood level (nmol/L)=[Month-12 NO blood level minus baseline NO blood level] divided by [baseline NO blood level] multiplied by 100, where all levels are in nmol/L.|Change in Baseline, Month-12|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.||percent change||Standard Error|Least Squares Mean
65865|NCT01151761|Primary|Progression-free Survival at 12 Months|Progression free survival is defined to be the time to progression of disease or death.|12 months|||participants|||Number
65200|NCT01157351|Secondary|Time to First Psychiatric Hospitalization or Arrest/Incarceration|A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant’s clinically significant worsening of symptoms of schizophrenia.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||Days||95% Confidence Interval|Median
65201|NCT01157351|Primary|Time to First Treatment Failure|Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.|From date of randomization up to Month 15|Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.||Days||95% Confidence Interval|Median
65202|NCT01157234|Secondary|Plasma Arginine (ARG) Level Change From Baseline to Month-12 Between Groups|Percent change in plasma Arginine (umol/L)=[month-12 plasma Arginine level minus baseline plasma Arginine level] divided by [baseline plasma Arginine level] multiplied by 100, where all levels are in umol/L|Baseline, Month-12|Technical limitations constrained measurements of plasma Arginine, resulting in no analysis for this outcome.|||||
65203|NCT01157234|Secondary|Plasma Asymmetric Dimethylarginine (ADMA) Change From Baseline to Month 12 Between the Groups|Percent change in plasma ADMA (umol/L)=[month-12 plasma ADMA level minus baseline plasma ADMA level] divided by [baseline plasma ADMA level] multiplied by 100, where all levels are in umol/L.|Baseline, Month-12|Technical limitations constrained measurements of Asymmetric Dimethylarginine (ADMA), resulting in no analysis for this outcome.|||||
65204|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Metoprolol in Transplant Recipients Age >/= 50 Years Old.||Change in Baseline, Month-12|||percent change||Standard Error|Least Squares Mean
65205|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-twelve of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Nebivolol in Transplant Recipients < 50 Years Old.||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.||percent change||Standard Error|Least Squares Mean
65206|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients < 50 Years Old Compared With Metoprolol in Transplant Recipients < 50 Years Old||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.||percent change||Standard Error|Least Squares Mean
65207|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients <50 Years Old Compared With Metoprolol in Transplant Recipients >/= 50 Years Old.||Baseline and Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.||percent change||Standard Error|Least Squares Mean
65208|NCT01157234|Other Pre-specified|Plasma Nitric Oxide Level (Nmol/L) at Month-12 Between the Groups.||12 Months|Full analysis set included all participants who signed inform consent and received at least one dose of study drug||nmol/L||Standard Error|Least Squares Mean
65209|NCT01157234|Secondary|Number of Antihypertensive Drug Classes Change From Baseline to Month-12 Between the Groups.|Percent change in quantity of Anti-Hypertensive Drug Classes (AHDC)=[Month-12 absolute number of AHDC minus baseline absolute number of AHDC] divided by [baseline absolute number of AHDC] multiplied by 100.|Change in Baseline, Month-12|Percent change||percent change||Standard Error|Least Squares Mean
65210|NCT01157234|Secondary|Mean Arterial Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|"Absolute change in Mean Arterial Blood Pressure, (MAP), (millimeter, Mercury= Month-12 sitting trough MAP minus baseline sitting trough MAP.~Mean Arterial Pressure= 2/3 trough diastolic blood pressure + 1/3 trough systolic blood pressure"|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||millimeter, Mercury||Standard Error|Least Squares Mean
65211|NCT01157234|Secondary|Diastolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|Absolute Change in Diastolic Blood Pressure (DBP), (millimeter, Mercury)= Month-12 sitting trough Diastolic Blood Pressure (millimeter, Mercury) level minus baseline sitting trough Diastolic Blood Pressure (millimeter, Mercury).|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||millimeter, mercury||Standard Error|Least Squares Mean
65212|NCT01157234|Secondary|Systolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 of Treatment Between the Groups|Absolute change in Systolic Blood Pressure (SBP), (millimeter, Mercury)=Month-12 sitting trough SBP level minus baseline sitting trough SBP level|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.||millimeter, Mercury||Standard Error|Least Squares Mean
65215|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65218|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65219|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estradiol.(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65220|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
65221|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65222|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65223|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
65224|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65225|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65226|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
65227|NCT01157182|Secondary|AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65228|NCT01157182|Secondary|AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65229|NCT01157182|Secondary|Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
65230|NCT01157182|Primary|AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65231|NCT01157182|Primary|AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
65232|NCT01157182|Primary|Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
65233|NCT01157182|Primary|AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
65234|NCT01157182|Primary|AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
65235|NCT01157182|Primary|Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
65236|NCT01157169|Secondary|AUC0-inf for Norbuprenorphine.|Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
65237|NCT01157169|Secondary|AUC0-t for Norbuprenorphine.|Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
65866|NCT01151579|Secondary|Total Number of Participants With Arrhythmias|Documented new arrhythmia occurring during study.|Five days|Number of patients for whom arrhythmias occurred within 5 days after treatment initiation.||participants|||Number
65238|NCT01157169|Secondary|Cmax for Norbuprenorphine.|Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
65239|NCT01157169|Primary|AUC0-inf for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
65240|NCT01157169|Primary|AUC0-t for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
65241|NCT01157169|Primary|Cmax of Buprenorphine.|Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
65242|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.||percentage of CD63+ basophils||Full Range|Median
65243|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.||percentage of CD63+ basophils||Full Range|Median
65244|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.||mgA/L||Full Range|Median
65245|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.||kUA/L||Full Range|Median
65246|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.||mgA/L||Full Range|Median
65247|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.||kUA/L||Full Range|Median
65248|NCT01157117|Secondary|Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test|A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score.|Month 32|All randomized participants who had not withdrawn from the study and came to the clinic for their Month 32 visit were assessed.||units on a scale||Full Range|Median
65249|NCT01157117|Secondary|Time to Maximum Tolerated Dose|Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Time to maximum tolerated dose could not be calculated because the maximum dose for the protocol was changed part way through the study after some subjects had already reached the maximum dose.|||||
65250|NCT01157117|Secondary|Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes.|Month 28|Participants who received any study treatment||percentage of participants|||Number
65251|NCT01157117|Secondary|Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)|Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing||mg milk powder||Standard Deviation|Mean
68681|NCT01121666|Secondary|Total Dose of r-hFSH Administered|Total dose of r-hFSH required was assessed.|Day of hCG administration (after maximum 16 days of r-hFSH treatment)|All participants were analyzed.||IU||Standard Deviation|Mean
65252|NCT01157117|Secondary|Incidence of Severe Hypersensitivity Reactions to Milk OIT|Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction.|Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)|Participants who received milk OIT dosing.||percentage of participants|||Number
65253|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase.|After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30|Participants who received milk OIT dosing during the Maintenance Phase.||percentage of participants|||Number
65254|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Escalation Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing during the Escalation Phase.||percentage of participants|||Number
65255|NCT01157117|Primary|Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.|Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||Percent of participants|||Number
65256|NCT01157078|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65257|NCT01157078|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11-point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65258|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.~The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65259|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.~The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65260|NCT01157078|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65261|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
68943|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to End of Treatment|Change in albumincorrected serum calcium from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)|||mmol/L||Standard Error|Mean
65262|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65263|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65264|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65265|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65266|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65267|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65268|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|"A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65269|NCT01157078|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65270|NCT01157078|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65311|NCT01156116|Secondary|Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2|"The average systolic blood pressure measured over a 24-hr period was calculated for each patient.~Change = Week 2 - Baseline."|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.||mmHg||95% Confidence Interval|Mean
65271|NCT01157078|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65272|NCT01157078|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65273|NCT01157078|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
65274|NCT01157078|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65275|NCT01157078|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65276|NCT01157078|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65277|NCT01157078|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65278|NCT01157065|Primary|Incidence of Events of Special Interest (ESI)|An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.|Up to Day 30|Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit||events|||Number
65312|NCT01156116|Secondary|Change From Baseline in Insulin Sensitivity (SI) at Week 2|"SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).~Change = Week 2 - Baseline."|Baseline and Week 2|One patient from each group was excluded from the analysis since they were missing SI data at both Baseline and Week 2.||[mU/L]^-1·[min]^-1||95% Confidence Interval|Mean
70648|NCT01102764|Secondary|Deployment Risk and Resiliency Inventory (DRRI): Self Report Measure Assessing 14 Key Deployment-related Risk and Resilience Factors With Demonstrated Implications for Veterans' Long Term Health||1 year||||||
65279|NCT01157065|Primary|Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4|The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.|Week 4|All patients who received study medication, completed at least one scheduled post-injection study visit, and did not receive standard therapy prior to Week 4 assessment||microns||Standard Deviation|Mean
65280|NCT01156987|Primary|Lesions|Number of lesions detected|at time of read by two radiologiests, compared to biopsy within 7 days.|||# of lesions detected|||Number
65281|NCT01156844|Secondary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 12 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
65282|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 48 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
65283|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0-24 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
65284|NCT01156844|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline to week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.||Liters||90% Confidence Interval|Least Squares Mean
65285|NCT01156792|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period|Participants were withdrawn if they met any of the following three criteria for ‘lack of efficacy’: 1) Clinic FEV1 below the FEV1 ‘Stability Limit’ value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF ‘Stability Limit’ for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher’s Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included.|Week 4 to Week 6|ITT Population.||Number of participants|||Number
65286|NCT01156792|Secondary|Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period|Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of nights||Standard Error|Least Squares Mean
65287|NCT01156792|Secondary|Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period|Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used (“rescue-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of nights||Standard Error|Least Squares Mean
65313|NCT01156116|Primary|Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2|"The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule .~Change = Week 2 - Baseline."|Baseline and Week 2|One patient in the Placebo group who withdrew prior to any testing was excluded from the analysis.||(mg/dL)*min||95% Confidence Interval|Mean
70649|NCT01102764|Secondary|Clinician Administered PTSD Scale (CAPS): PTSD Diagnosis||1 year||||||
65288|NCT01156792|Secondary|Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period|Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used (“rescue-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of days||Standard Error|Least Squares Mean
65289|NCT01156792|Secondary|Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period|Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from ‘0’ (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced (“symptom-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of nights||Standard Error|Least Squares Mean
65290|NCT01156792|Secondary|Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period|Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from ‘0’ (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced (“symptom-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Percentage of days||Standard Error|Least Squares Mean
65291|NCT01156792|Secondary|Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period|A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Number of inhalations||Standard Error|Least Squares Mean
65292|NCT01156792|Secondary|Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period|Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from ‘0’ (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Score on a scale||Standard Error|Least Squares Mean
65293|NCT01156792|Secondary|Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||L/min||Standard Error|Least Squares Mean
65294|NCT01156792|Secondary|Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||L/min||Standard Error|Least Squares Mean
65295|NCT01156792|Secondary|Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Liters/minute (L/min)||Standard Error|Least Squares Mean
65573|NCT01153724|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set||percentage of olodaterol||Geometric Coefficient of Variation|Geometric Mean
65296|NCT01156792|Primary|Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant’s last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.|End of Week 6|ITT Population. Only those participants available at the specified time point were analyzed.||Liters (L)||Standard Error|Least Squares Mean
65297|NCT01156701|Other Pre-specified|Number of Participants Experiencing Hospitalization or Death Due to Influenza|The frequency of hospitalization and death in the study population was analyzed.|Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
65298|NCT01156701|Other Pre-specified|Number of Patients With Respiratory Outcomes||Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
65299|NCT01156701|Secondary|Number of Patients With Any Respiratory Diagnosis|The frequency of any respiratory diagnosis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
65300|NCT01156701|Secondary|Number of Patients With Bronchitis|The frequency of bronchitis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
65301|NCT01156701|Secondary|Number of Patients With Pneumonia|The frequency of pneumonia among the four cohorts was measured..|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
65302|NCT01156701|Secondary|Number of Patients With Asthma|The frequency of asthma among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
65303|NCT01156701|Primary|Number of Patients With Influenza|The frequency of influenza among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).||patients|||Number
65304|NCT01156597|Secondary|Cholesterol Efflux Capacity of HDL|The ability of serum HDL to remove cholesterol from cultured cells will be assessed as an in vitro method to evaluate a functional changes in HDL mediated by changes due to pioglitazone treatment. Cells were incubated with 2% serum from each study subject diluted in culture medium and incubations were performed for a total of 4 hours. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool as described in detail by de la Llera-Moya et al (de la Llera-Moya M, Drazul-Schrader D, Asztalos BF, Cuchel M, Rader DJ, Rothblat GH. The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages. Arterioscler Thromb Vasc Biol. 2010 Apr;30(4):796-801. doi: 10.1161/ATVBAHA.109.199158. PMID: 20075420).|24 weeks|||Ratio||Standard Deviation|Mean
65305|NCT01156597|Secondary|HDL Apolipoprotein Levels at Study End-point|Lipoproteins will be isolated and analyzed using the gradient ultracentrifugation-high pressure liquid chromatography technique to isolate very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL, and high density lipoprotein (HDL) subfractions. Protein and lipid compositions of HDL is determined|24 weeks|||mg/dL||Standard Deviation|Mean
65306|NCT01156597|Primary|Increased HDL-Cholesterol and Decreased Triglycerides|"The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation:~Change=[100%*(Endpoint value – Baseline Value)/Baseline Value]"|24 weeks|All subjects that completed the study were used for the final analysis||% Change||Standard Deviation|Mean
65307|NCT01156571|Secondary|Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild|GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial|48 hours after randomization|||participants|||Number
65308|NCT01156571|Secondary|Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)|CEC-adjudicated results (mITT population)|48 hours after randomization|||participants|||Number
65309|NCT01156571|Primary|The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)|Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)|48 hours after randomization|||participants|||Number
65310|NCT01156116|Secondary|Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2|"The average diastolic blood pressure over a 24-hr period was calculated for each patient.~Change = Week 2 - Baseline"|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.||mmHg||95% Confidence Interval|Mean
86667|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)|4 weeks|||Micrograms||Standard Deviation|Mean
65314|NCT01156051|Secondary|Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)|Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.||minutes||Standard Deviation|Mean
65315|NCT01156051|Secondary|Change in Baseline to Treatment Latency to Persistent Sleep (LPS)|Change in an objective measure of sleep onset, using polysomnography.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.||minutes||Standard Deviation|Mean
65316|NCT01156051|Secondary|Change in Baseline to Treatment ADHD-Rating Scale IV Total Score|Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).|Baseline to last observation carried forward (after at least one week of dose stability)|29 children enrolled, but two were discontinued before termination data was available: one (treatment) was lost to follow up and one (placebo) was noncompliant with the protocol.||units on a scale||Standard Deviation|Mean
65317|NCT01156051|Primary|Change in Polysomnographic Total Sleep Time (TST)|Change in objective measures of sleep, using polysomnography|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled, one (treatment) was lost to follow up an one (placebo) was discontinued due to noncompliance with protocol.||minutes||Standard Deviation|Mean
65318|NCT01156012|Primary|Change From Baseline in Intraocular Pressure (IOP)|"The worse eye is defined as:~If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.~If only one eye is eligible this eye is the worse eye.~If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.~If both eyes have the same IOP at D0 the worse eye is the right eye."|Day 0 and Day 84|mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.||mmHg||Standard Deviation|Mean
65319|NCT01155999|Primary|The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3|Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).|Day 3|The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye.||participants|||Number
65320|NCT01155869|Secondary|Treatment Participation|Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation|16 weeks|||percentage of visits|Participants||Number
65321|NCT01155869|Primary|Mean Weekly Self-reported Alcohol Consumption|Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.|24 weeks|||standard drink||Standard Deviation|Mean
65322|NCT01155830|Secondary|TNF-alpha, Maximum|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|up to 2 weeks|||pg/mL||Standard Error|Mean
65323|NCT01155830|Primary|TNF-alpha, Baseline|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|Baseline|||pg/mL||Standard Error|Mean
65324|NCT01155726|Primary|Average Subjective Comfort|"Participants were asked, How would you rate your comfort with your study lenses? and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together."|Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3|Per protocol||Units on a scale||Standard Deviation|Mean
65325|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65326|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65339|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
65327|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65328|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65329|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65330|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65331|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 24|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65332|NCT01155570|Secondary|Physician’s Overall Response Rating At Week 24|"Overall response rating, according to investigator’s subjective clinical opinion. The level of overall improvement rating was categorized as “markedly improved,” “improved,” “not changed,” or not assessable, comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions."|Baseline and Week 24|Participants in the Efficacy Analysis Population with assessment at Week 24.||participants|||Number
65333|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 16|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65334|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 4|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65335|NCT01155570|Primary|Dermatology Life Quality Index at Week 24|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65336|NCT01155570|Primary|Dermatology Life Quality Index at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65337|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
65338|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
65340|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||percentage of participants|||Number
65341|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65342|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65343|NCT01155570|Primary|Physician's Global Assessment at Week 24|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65344|NCT01155570|Primary|Physician's Global Assessment at Week 16|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65345|NCT01155570|Primary|Physician's Global Assessment At Week 8|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 8|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65346|NCT01155570|Primary|Physician's Global Assessment at Week 4|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 4|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.||units on a scale||Standard Deviation|Mean
65347|NCT01155570|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs|This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than “not related” (ie, “probable,” “possible,” or “unclear”). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.|From study registration through Week 24|Safety Analysis Population||participants|||Number
65348|NCT01155531|Primary|Safety of Sertraline and Telenzepine Combination|safety of the drug combination was measured in terms of number of adverse events during the study period.|7 days|||number of adverse events|||Number
65574|NCT01153724|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set||Hours||Full Range|Median
65349|NCT01155531|Primary|Changes in the Meal Calories Consumed|The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.|The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.|||calorie||Standard Deviation|Mean
65350|NCT01155531|Primary|Changes in the VAS Score From Baseline.|The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject’s room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: “How hungry are you now?” The anchor points of the 100mm scale were “I am not hungry at all” and “Never more hungry” corresponding to 0 mm and 100 mm respectively. The subjects’ VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group.|The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal|||mm||Standard Deviation|Mean
65351|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 2|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated (APaT): All participants who received at least one dose of study treatment.||Participants|||Number
65352|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated: All participants who received at least one dose of study treatment.||Participants|||Number
65353|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 1|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.||Participants|||Number
65354|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.||Participants|||Number
65355|NCT01155479|Secondary|Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.||Score on a Scale||Standard Error|Mean
65356|NCT01155479|Secondary|Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)|UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.||Percentage of Responders||95% Confidence Interval|Number
65357|NCT01155479|Primary|Change From Baseline in the Sum of Unified Parkinson’s Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.||Score on a Scale||Standard Error|Mean
65358|NCT01155466|Secondary|"Change From Baseline at Week 12 in Mean On Time Without Troublesome Dyskinesia"|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.||Hours/day||Standard Error|Mean
65359|NCT01155466|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit."|Baseline and Week 12|The number of randomized and treated participants with a Week 12 value.||Percentage of participants|||Number
65360|NCT01155466|Primary|Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24.|Baseline and Week 12|The number of participants who received at least one dose of study drug and had baseline and Week 12 data||Scores on a scale||Standard Deviation|Mean
65361|NCT01155466|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|The number of participants who received at least one dose of study drug||Percentage of participants|||Number
65362|NCT01155466|Primary|Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with aspartate aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
65363|NCT01155466|Primary|Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with alanine aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
65364|NCT01155466|Primary|Number of Participants With Diastolic Blood Pressure >=105 mm Hg|The number of participants with Diastolic Blood Pressure >=105 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
65365|NCT01155466|Primary|Numberof Participants With Systolic Blood Pressure >=180 mm Hg|The number of participants with Systolic Blood Pressure >=180 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug||Participants|||Number
65366|NCT01155466|Primary|"Change From Baseline in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.||Hours/day||Standard Error|Mean
65367|NCT01155336|Secondary|Cardiac Electrophysiology|A 20-minute supine 12-lead Holter ECG will allow the quantification of a series of standard ECG parameters as well as provide insight into frequency-domain HRV parameters, QRS duration and morphology, using signal-averaged ECG (SAECG), repolarization morphology, and variability utilizing specialized programs.|1 week||||||
65368|NCT01155336|Primary|Platelet Function|Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis. The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine. It is meant to imitate clotting in human arteries.|12 hours|We did not complete the study and no subjects were randomized to corn oil||seconds||Full Range|Mean
65369|NCT01155323|Primary|Limbal Hyperemia|This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.|after 1 week of wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
65370|NCT01155323|Primary|Subjective Rating of Quality Perceptions|This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
65867|NCT01151579|Secondary|Arrhythmias|Any new arrhythmia documented in the medical record that occurred between breathing treatments.|15 minutes after each treatment for average of 3 to 5 days|The percentage of arrhythmias among the number of breathing treatments.||percent|||Number
65371|NCT01155323|Primary|Corneal Staining|Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
65372|NCT01155323|Primary|Subjective Rating of Handling|This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
65373|NCT01155323|Primary|Vision Quality|This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
65374|NCT01155323|Primary|Subjective Rating of Comfort|This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.||Units on a scale||Standard Error|Least Squares Mean
65375|NCT01155219|Primary|Ocular Tolerance|Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.|Day 84|Full Analysis Set||participants|||Number
65376|NCT01155167|Secondary|Radial Artery Patency|Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).|24 hours|per protocol||participants|||Number
65377|NCT01155167|Secondary|Radial Artery Spasm During Catheterization|The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.|2 hours|All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded||participants|||Number
65378|NCT01155167|Primary|Change in Radial Artery Diameter|The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.|Baseline and after 30 minutes of drug application|||Percent change||Standard Deviation|Mean
65379|NCT01155154|Primary|Number of Participants With Presence of Wound Infection|Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.|2 weeks|||participants|||Number
65380|NCT01155141|Secondary|Total Cholesterol||Baseline - Month 6|||mg/dL||Standard Deviation|Median
65381|NCT01155141|Secondary|Glucose||Baseline - Month 6|||mg/dL||Standard Deviation|Median
65382|NCT01155141|Secondary|Diastolic Blood Pressure||Baseline - Month 6|||mm Hg||Standard Deviation|Median
65383|NCT01155141|Secondary|Systolic Blood Pressure||Baseline - Month 6|||mm Hg||Standard Deviation|Median
65384|NCT01155141|Secondary|Weight||Baseline - Month 6|||kg||Standard Deviation|Median
65385|NCT01155141|Primary|Protein/Creatinine Ratio||Baseline - Month 6|||unitless||Standard Deviation|Median
65386|NCT01155141|Secondary|eGFR||Baseline - Month 6|||mL/min/1.73m^2||Standard Deviation|Median
65387|NCT01155141|Primary|Serum Creatinine||Baseline - Month 6|||mg/dL||Standard Deviation|Median
65388|NCT01155141|Primary|24 Hour Proteinuria||Baseline - Month 6|||g/day||Standard Deviation|Median
65389|NCT01155063|Secondary|Percentage of Participants With Recurrent Disease|Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).|Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
65390|NCT01155063|Secondary|Time to Discontinuation of Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
65391|NCT01155063|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
65392|NCT01155063|Secondary|Percentage of Participants Who Discontinued the Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.|||||
65393|NCT01155063|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||Participants|||Number
65394|NCT01155063|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||Participants|||Number
65395|NCT01155063|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.||Participants|||Number
65671|NCT01153321|Secondary|TNF-α Concentration in Blood (Post-LPS Challenge)|TNF-α concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65396|NCT01155024|Secondary|Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket|Number of participants indicating socket preference after 3 months usage of the direct manufactured prosthetic socket. Comparisons made to their previous traditional definitive prosthetic socket|3 months|Total number of participants completing the period (3 months usage of direct manufactured socket) and participants classified as 'Withdrawal by participant'. Analysis does not include participants who prematurely withdrew for reasons unrelated to the direct manufactured socket intervention.||participants|||Number
65397|NCT01155024|Secondary|Participant Socket Preference After Initial Fitting|Number of participants indicating socket preference after initial fitting of both socket interventions|Within the first 4-6 hours|Total number of participants completing period for both study interventions.||participants|||Number
65398|NCT01155024|Primary|Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting|The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)|Within the first 4-6 hrs|Per protocol analysis including all consented participants||score on scale||Standard Deviation|Mean
65399|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups"|6 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment||U/L||Standard Deviation|Mean
65400|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups"|3 month endpoint|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment||U/L||Standard Error|Least Squares Mean
65401|NCT01154985|Primary|Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies|"Patient is considered a responder if histological examination shows:~Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis~A priori threshold for statistical significance is p<0.05, 1-sided"|12 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment||participants|||Number
65402|NCT01154673|Primary|Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.|The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen.|Baseline to Week 48|||HIV DNA copies/ million CD4 cells||Full Range|Median
65403|NCT01154634|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.|Pre-entry to follow-up|||Participants|||Number
65404|NCT01154634|Secondary|Terminal Half-life (T Half)|Terminal half-life (T half)|0 to 12 hours post dose|"Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.~Two samples were not analyzed for T half due to technical reasons."||hours||95% Confidence Interval|Geometric Mean
65405|NCT01154634|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration (Tmax)|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||hours||Full Range|Median
65406|NCT01154634|Secondary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||nmol/L||95% Confidence Interval|Geometric Mean
65407|NCT01154634|Secondary|Average Plasma Concentration (C Average)|Average plasma concentration|1 to 4 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||nmol/L||95% Confidence Interval|Geometric Mean
65408|NCT01154634|Secondary|Area Under the Plasma Concentration Curve(AUC)|Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.||nmol*h/L||95% Confidence Interval|Geometric Mean
65409|NCT01154634|Secondary|Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal|Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.|0 to 3 hours post meal|Data from two subjects were excluded from efficacy analysis due to incorrect medication received Data from five visits from two subject were excluded form analysis due to deviations caused by technical problems.||relaxations||Full Range|Geometric Mean
65410|NCT01154634|Primary|Reflux Episodes 0 to 3 Hours Post Meal|Total number of reflux episodes 0 to 3 hours post meal|0 to 3 hours post meal|Data from two subjects (one in arm AZD2516 5 mg, and one in arm Placebo) were excluded from efficacy analysis due to incorrect medication received.||Episodes||Full Range|Geometric Mean
65411|NCT01154452|Secondary|Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 4 months|||participants|||Number
65412|NCT01154452|Primary|Progression-free Survival (PFS) of the Combination of RO4929097 With and Without GDC-0449 in Patients With Advanced Sarcoma. (Phase II)|Progression-free survival (PFS) of the combination of RO4929097 with and without GDC-0449 in patients with advanced sarcoma. (Phase II)|1 year||||||
65413|NCT01154452|Primary|Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)||Up to 28 days|||mg|||Number
65414|NCT01154335|Secondary|Response Rate|Response rate (RR) will be estimated as the proportion of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Only patients who received at least 8 weeks of treatment were considered evaluable for response and were included in the response rate analysis||participants|||Number
65415|NCT01154335|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time between Day 1 Cycle 1 to the date of death from any cause. Those remaining alive will be censored at their last known assessment or follow-up.|18 months|||weeks||95% Confidence Interval|Median
65416|NCT01154335|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time between Day 1 Cycle 1 and date of first documented recurrence or death. Patients who do not exhibit progression while on trial will be censored at their last known assessment. Progression is defined per RECIST criteria as either 1) at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum. OR 2) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|18 Months|||weeks||95% Confidence Interval|Median
65417|NCT01154335|Primary|To Determine the Maximum Tolerated Dose (MTD) of the Combination of OSI-906 and Everolimus for the Treatment of Patients With Refractory Metastatic Colorectal Cancer.||18 Months|||milligrams|||Number
65418|NCT01154322|Primary|Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|AHI after min 21 days use with Pixi mask|||AHI (events/hour)||Standard Deviation|Mean
65419|NCT01154322|Primary|Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|Baseline AHI|Subjects who completed all visits and procedures||AHI (events/hour)||Standard Deviation|Mean
65420|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts With Substance Use|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.|6 months post randomization|||sex acts with substance use|||Number
65421|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Partners|Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.|6 months post randomization|||unprotected partners||Standard Error|Least Squares Mean
65422|NCT01154296|Secondary|Sexual Risk Behavior -- # of Partners|Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.|6 months post randomization|||partners||Standard Error|Least Squares Mean
65423|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Sex Acts|Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts|6 months post randomization|||unprotected sex acts||Standard Error|Least Squares Mean
65424|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.|6 months post randomization|||sex acts||Standard Error|Least Squares Mean
65425|NCT01154296|Primary|STI Incidence|Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.|6 months post randomization|||participants|||Number
65426|NCT01154283|Secondary|EuroQol Visual Analogue Scale(VAS)|Quality of life assessed with visual analogue scale. Where the patient is asked to place a mark on a piece of paper with a vertical, scale from 100 at the top to 0 at the bottom of the scale. Where the patient is informed that 100 represents his or her best imaginable health state and 0 is his or her worst imaginable health state.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report quality of life at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete quality of life assessments.||units on a scale||Standard Deviation|Mean
65427|NCT01154283|Secondary|Transitional Dyspnea Index|Transitional Dyspnea Index scores patient reported changes in difficulty breathing during each intervention period from -3 (major deterioration) to +3 (major improvement) in three categories: functional impairment, magnitude of task, and magnitude of effort. The total TDI score ranges from -9 to +9.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report dyspnea at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete dyspnea assessments.||units on a scale||Standard Deviation|Mean
65428|NCT01154283|Secondary|"Patient Preference (Likert Scale) Definitely IPAP-only Probably IPAP-only Uncertain Probably Bi-level Definitely Bi-level"|"Patient Preference of NIPPV mode:~definitely IPAP-only probably IPAP-only uncertain probably Bi-level definitely Bi-level Number of patients who chose definitely or probably are reported."|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died before completion of 12 weeks (second intervention) and could not have patient preference assessed.||participants|||Number
65514|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)||Week 12 (End of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage of Participants|||Number
65429|NCT01154283|Primary|Hours of NIPPV Usage|Patients experienced the first intervention period during weeks 1-6 and the second intervention period during weeks 7-12. Patients were given one week to learn how to use the NIPPV equipment at the beginning of each intervention period. Therefore, only the total NIPPV hours used during the last 5 weeks of each intervention period were collected and divided by the number of weeks to obtain the average, weekly hours of NIPPV usage assessed at 6 weeks (first intervention) and 12 weeks (second intervention) for each patient.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|||hours||Full Range|Mean
65430|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
65431|NCT01154218|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
65432|NCT01154218|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N = 35' is signifying those participants who were evaluable for this measure at the specified time point for crizotinib CIC fed arm group.||ng*hr/mL||Standard Deviation|Geometric Mean
65433|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
65434|NCT01154218|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
65435|NCT01154218|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
65436|NCT01154218|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
65437|NCT01154218|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
65438|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
65439|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
65440|NCT01154218|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
65441|NCT01154166|Secondary|Time to Reinstatement of L-dopa Following a Reduction in Dose Using LOCF|The mean number of days after which the dose of L-dopa was readministered after the reduction in dose was recorded.|Baseline to Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.||days||Standard Deviation|Mean
65460|NCT01154140|Secondary|Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)|Hospitalization details were evaluated in this study. Data regard to hospitalizations were summarized from information in the case report forms.|From 28 days prior to the start of study treatment and up to 28 days post the last dose of study treatment|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants|||Number
65442|NCT01154166|Secondary|Mean Change From Baseline in the Parkinson's Disease Quality of Life Scores (PDQ39) Using LOCF|The PDQ39 is a 39 item self-administered questionnaire. The questionnaire covers eight domains of health that are reported as adversely affected by patients with PD. Participants were asked to rate responses on a scale from 0 to 4 (“never” to “always”). The overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem). Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points for the indicated domain were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
65443|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Parkinson's Disease Sleep Scale (PDSS) Total Score Using LOCF|The PDSS uses a series of 15 questions to assess sleep disturbance associated with PD. Participants completed the assessments based on their experiences in the past week by marking a cross on each 10 centimeter (cm) scale (labelled from worst to best state). Responses were quantified by measuring the distance along each line where the cross was placed. The scores for each item ranged from 0 (symptom severe and always experienced) to 10 (symptom free). The maximum cumulative score for the PDSS was thus 150 (free of all symptoms). Change from BL=value at Week 24 minus the BL value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
65444|NCT01154166|Secondary|Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF|The HAMD-17 is a 17-item scale that is completed by the investigator. Each item was evaluated and scored using either a 5-point scale (e.g., absent, mild, moderate, severe, very severe) or a 3-point scale (e.g., absent, mild, marked). The total HAMD-17 score (sum of the scores of all 17 items) may range from 0 (least severe) to 52 (most severe). Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
65445|NCT01154166|Secondary|Number of Responders to Study Treatment Using LOCF|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Responders are defined as participants who had at least a 20% reduction from Baseline in awake time spent off and at least a 20% reduction from Baseline in the L-dopa dose."|Baseline to Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||participants|||Number
65446|NCT01154166|Secondary|Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF|In the event of unacceptable side effects relative to Baseline (e.g., dyskinesias, dystonias [neurological movement disorder]) the dosage of L-dopa was reduced. If there was reduction in the side effects and there was loss of symptom control, the dose of study medication was again increased (reinstated) at subsequent visits. If symptoms could still not be controlled, then L-dopa was reinstated; however, the dose could not exceed the baseline dose.|Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.||participants|||Number
65447|NCT01154166|Secondary|Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF|The CGI global improvement scale allows the investigator to rate the participant’s total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be responders.|Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||participants|||Number
65448|NCT01154166|Secondary|Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF|The UPDRS assesses six features of PD impairment, including Activities of Daily Living (ADL). The total ADL score ranges from 0 to 52, where 0= normal/no symptoms and 52= worst possible case. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
65449|NCT01154166|Secondary|Mean Change From Baseline in Total Awake Time “on” Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF|Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Participants were asked to record the number of awake hours spent ”on” without TD in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent“on”without TD per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.||hours||Standard Deviation|Mean
65450|NCT01154166|Secondary|Mean Change From Baseline in Total Awake Time Spent “on” at Week 24 Using LOCF|"The on state is defined as the state in which the PD symptoms (lack of mobility, tremor, or rigidity) are adequately controlled by the drug. Participants were asked to record the duration of their “on” periods in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent “on” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.||hours||Standard Deviation|Mean
65451|NCT01154166|Secondary|Mean Change From Baseline in the Percentage of Awake Time Spent “Off” (ATSO) at Week 24 Using LOCF|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their “off” periods in 24-hour diary cards prior to each visit on the same 2 days of each relevant week. The total number of awake hours spent “off” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. The percentage of ATSO=ATSO divided by (ATSO + awake time spent on) * 100. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.||Percentage of time||Standard Deviation|Mean
65452|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF|The UPDRS, a clinician-based rating scale, assesses 6 features of PD impairment: (1) mentation, behavior, and mood; (2) activities of daily living; (3) motor examination; (4) complications of therapy; (5) modified Hoehn and Yahr stage; (6) Schwab and England activities of daily living scale. Assessments were conducted when participants had benefit in regard to mobility, tremor, and rigidity. The total motor score (sum of motor examination) ranges from 0 to 108: 0=normal/no symptoms; 108=worst possible case. Change from BL was calculated as the value at Week 24 minus the value at BL.|Baseline and Week 24 (Visit 13)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.||scores on a scale||Standard Deviation|Mean
65453|NCT01154166|Primary|"Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF)"|"The off state is defined as the state in which Parkinson’s Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent “off” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24 (Visit 13)|Intent-to-treat (ITT) Population: all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. In the LOCF dataset, the last available on-therapy observation for a participant is used to estimate missing data points.||hours||Standard Deviation|Mean
65454|NCT01154153|Secondary|The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase|The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0.|From randomization to 43-50 days postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Percentage of days||Standard Deviation|Mean
65455|NCT01154153|Secondary|Number of Participants Using Rescue Medication|The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study).|From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Participants|||Number
65456|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Participant|Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Participants|||Number
65457|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Physician|Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Participants|||Number
65458|NCT01154153|Secondary|Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)|"Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms).~Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase)."|From 8-24 days prerandomization up to 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Score on a scale||Standard Deviation|Mean
65459|NCT01154153|Primary|Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline|"Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times.~Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis."|1-3 days prerandomization and 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.||Ratio||Full Range|Geometric Mean
65461|NCT01154140|Secondary|Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)|The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting “no health problems,” “moderate health problems,” and “extreme health problems.” The EQ VAS records the respondent’s self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Baseline up to treatment withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EQ-5D analysis||Units on a scale||95% Confidence Interval|Mean
65462|NCT01154140|Secondary|Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.|Cycle 1 day 1 to end of treatment or withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EORTC QLQ-LC13 analysis.||Units on a scale||95% Confidence Interval|Mean
65463|NCT01154140|Secondary|Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Cycle 1 day 1 to end of treatment or withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EORTC QLQ-C30 analysis.||Units on a scale||95% Confidence Interval|Mean
65464|NCT01154140|Secondary|Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Cycle 1 day 1 to end of treatment or withdrawal or crossover|PRO evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment. N = Total participants in PRO evaluable population set for EORTC QLQ-C30 analysis.||Units on a scale||95% Confidence Interval|Mean
65465|NCT01154140|Secondary|Time to Deterioration (TTD) in Pain in Chest, Dyspnea, or Cough|TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The median TTD mentioned in below table was based on Brookmeyer and Crowley method.|From Baseline to deterioration while on study treatment|The Patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline (last PRO assessment prior to randomization day) and at least 1 postbaseline PRO assessment prior to crossover or end of randomized study treatment.||Months||95% Confidence Interval|Median
65466|NCT01154140|Secondary|ORR Between ALK Variant Groups Based on IRR|A mandatory tumor sample (archived or fresh) was required at screening for detecting ALK gene fusion events in order to determine the eligibility of participants to enter the study. The Vysis ALK Break Apart Fluorescence In Situ Hybridization (FISH) test was used as the primary assay. Only those participants whose tissue sample was positive for the ALK gene fusion by FISH testing by the central laboratory were allowed to enter the study. Testing for ALK gene fusion variants was performed using the Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test. Percentage of participant with complete or partial response was according to RECIST version 1.1 by type of ALK gene fusion variant.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The ALK gene fusion variant evaluable population was defined as participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).||Percentage of participants||95% Confidence Interval|Number
65501|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase I)|Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65467|NCT01154140|Secondary|Percentage of Participants for Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants|A mandatory tumor sample (archived or fresh) was required at screening for detecting ALK gene fusion events in order to determine the eligibility of participants to enter the study. The Vysis ALK Break Apart Fluorescence In Situ Hybridization (FISH) test was used as the primary assay. Only those participants whose tissue sample was positive for the ALK gene fusion by FISH testing by the central laboratory were allowed to enter the study. Testing for ALK gene fusion variants was performed using the Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test.|Screening|The ALK gene fusion variant evaluable population was defined as participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).||Percentage of participants with variant|||Number
65468|NCT01154140|Secondary|Plasma Predose Concentration (Trough Concentration [Ctrough]) of Crizotinib and Its Metabolite|This analysis was performed in crizotinib arm only. Plasma samples for pharmacokinetic (PK) assessment were to be obtained prior to (predose) and around the time to maximum plasma concentration (Tmax) following morning dosing (at 2 to 6 hours postdose until Protocol Amendment 6 which changed the timing of PK sampling to 3 and 5 hours postdose) on Day 1 of Cycles 2, 3, and 5.|Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 5 Day 1|The PK concentration population (also referred to as the PK evaluable population) included any participant in the SA population who had at least 1 plasma concentration of crizotinib or its metabolite, PF 06260182, determined following crizotinib treatment as of the data cutoff date.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
65469|NCT01154140|Secondary|Percentage of Participants With Treatment-emergent AEs (Treatment Related)|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in the below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death related to AE. Chemotherapy group in the below table, only includes data before crossover to crizotinib for those participants who crossed over to receive crizotinib treatment.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses.|SA population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.||Percentage of participants|||Number
65470|NCT01154140|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (AEs; All Causalities)|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Chemotherapy group in the below table includes data before crossover to crizotinib for participants who crossed over to receive crizotinib.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses|The safety analysis (SA) population included all randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.||Percentage of participants|||Number
65471|NCT01154140|Secondary|Time to Extracranial Progression (EC-TTP) Based on IRR|EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. The median EC-TTP presented in below table was based on Brookmeyer and Crowley method.|Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
65472|NCT01154140|Secondary|Time to Intracranial Progression (IC-TTP) Based on IRR|IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. The median IC-TTP presented in below table was based on Brookmeyer and Crowley method.|Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
65473|NCT01154140|Secondary|Time to Progression (TTP) Based on IRR|TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44. The median TTP presented in below table was based on Brookmeyer and Crowley method,|Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
65515|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage of Participants|||Number
65474|NCT01154140|Secondary|Percentage of Participants With Disease Control at Week 12 Based on IRR|Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization to Week 12|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants||95% Confidence Interval|Number
65475|NCT01154140|Secondary|Time to Tumor Response (TTR) Based on IRR|TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response.|Randomization to first documentation of objective tumor response (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR.||Weeks||Full Range|Median
65476|NCT01154140|Secondary|Duration of Response (DR) Based on IRR|DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death − first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response. The median duration of response presented in below table was based on Brookmeyer and Crowley method.|From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months).|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR.||Weeks||95% Confidence Interval|Median
65477|NCT01154140|Secondary|Objective Response Rate - Percentage of Participants With Objective Response as Assessed by IRR|Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percentage of participants||95% Confidence Interval|Number
65478|NCT01154140|Secondary|OS Probability at Months 12 and 18|OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − date of randomization +1)/30.44.|Months 12 and 18|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Percent probability||95% Confidence Interval|Number
65479|NCT01154140|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − date of randomization +1)/30.44.|From randomization to death or last date known alive for those not known to have died (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
65480|NCT01154140|Primary|Progression-Free Survival (PFS) Based on Independent Radiology Review (IRR) by Treatment Arm|PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date − randomization date +1)/30.44.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization.||Months||95% Confidence Interval|Median
65481|NCT01154127|Secondary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1|"SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise.~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 1|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||Seconds||95% Confidence Interval|Least Squares Mean
65482|NCT01154127|Secondary|Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The modified Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of leg discomfort before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||units on a scale||95% Confidence Interval|Least Squares Mean
65483|NCT01154127|Secondary|Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||units on a scale||95% Confidence Interval|Least Squares Mean
65484|NCT01154127|Secondary|Specific Airways Conductance (SGaw)|"SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)*kP). Whole body plethysmography (Bodybox) was used to measure SGaw.~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||litres/(Second*kpa); kpa = kilopascal||95% Confidence Interval|Least Squares Mean
65485|NCT01154127|Secondary|Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)|"Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs.~Total Lung Capacity (TLC) is the best vital capacity plus residual volume. Whole body plethysmography (Bodybox) was used to measure SVC and TLC. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period)."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.||Litres||95% Confidence Interval|Least Squares Mean
65486|NCT01154127|Secondary|Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|"FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured with spirometry conducted according to internationally accepted standards.~FVC is the volume of air that can forcibly be blown out after full inspiration and is used in spirometry tests.~The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||Litres||95% Confidence Interval|Least Squares Mean
65487|NCT01154127|Secondary|Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|"IC at peak was observed using spirometry. However, two different methodologies (whole body plethysmography (Bodybox) and spirometry) were used to observe IC at rest.~The analysis of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.||Litres||95% Confidence Interval|Least Squares Mean
65488|NCT01154127|Secondary|Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|Isotime is the last matching timepoint in the submaximal exercise tolerance test (SMETT) at which for both periods the patient has a test result. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting primary the PD assessment.||Liters||95% Confidence Interval|Least Squares Mean
65489|NCT01154127|Primary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment|SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.||seconds||95% Confidence Interval|Least Squares Mean
65490|NCT01154036|Secondary|Percent Change From Baseline in Hs-CRP (Phase II)|hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage Change||95% Confidence Interval|Least Squares Mean
65502|NCT01154036|Secondary|Percent Change From Baseline in Apo A-I (Phase II)|Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65491|NCT01154036|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)|hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||95% Confidence Interval|Least Squares Mean
65492|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)|Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65493|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)|Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65494|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)|Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65495|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)|Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65496|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)|LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65497|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)|LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65498|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase II)|TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65499|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase I)|TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65500|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase II)|Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65672|NCT01153321|Secondary|TNF-α Concentration in Blood (Pre-LPS Challenge)|TNF-α concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65503|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)|Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65504|NCT01154036|Secondary|Percent Change From Baseline in Apo B (Phase II)|Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65505|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)|Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65506|NCT01154036|Secondary|Percent Change From Baseline in HDL-C (Phase II)|HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65507|NCT01154036|Secondary|Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)|HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65508|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase II)|TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage Change||95% Confidence Interval|Least Squares Mean
65509|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase I)|TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||95% Confidence Interval|Least Squares Mean
65510|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase II)|TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65511|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase I)|TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.||Percentage Change||Standard Deviation|Median
65512|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)||Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II||Percentage of Participants|||Number
65513|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.||Percentage of Participants|||Number
65516|NCT01154036|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).|LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).|Baseline (Week 6) and Week 12|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II||Percentage Change||Standard Deviation|Median
65517|NCT01154036|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)|LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).|Baseline and Week 6 (end of Phase I )|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participant who received at least one dose of study drug during Phase I and had a baseline or at least one measurement available during Phase I||Percentage Change||Standard Deviation|Median
65518|NCT01153971|Secondary|DR - Time to Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population: only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.||months||Standard Error|Mean
65519|NCT01153971|Secondary|DR - Percentage of Participants With an Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.||percentage of participants|||Number
65520|NCT01153971|Secondary|Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response|DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.||percentage of participants||95% Confidence Interval|Number
65521|NCT01153971|Secondary|PFS - Time to Event|"Progression-free survival was defined as the time from treatment start to the date of documented disease progression.~NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time."|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||months||Standard Error|Mean
65522|NCT01153971|Secondary|PFS - Percentage of Participants With an Event|Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants|||Number
65523|NCT01153971|Secondary|Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free|PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants||95% Confidence Interval|Number
65524|NCT01153971|Secondary|DFS - Time to Event|"DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.~NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time."|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.||months||Standard Error|Mean
65525|NCT01153971|Secondary|DFS - Percentage of Participants With an Event|DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.||percentage of participants|||Number
65673|NCT01153321|Secondary|IL-8 Concentration in Blood (Post-LPS Challenge)|IL-8 concentration in blood post-LPS challenge (Day 11)|day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65526|NCT01153971|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free|DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.||percentage of participants||95% Confidence Interval|Number
65527|NCT01153971|Secondary|OS - Time to Event|Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population||months||Standard Error|Mean
65528|NCT01153971|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population||percentage of participants|||Number
65529|NCT01153971|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive|OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants||95% Confidence Interval|Number
65530|NCT01153971|Secondary|FFS - Time to Event|"FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date.~NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time."|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||months||Standard Error|Mean
65531|NCT01153971|Secondary|FFS - Percentage of Participants With an Event|FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants|||Number
65532|NCT01153971|Secondary|Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death|FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population||percentage of participants||95% Confidence Interval|Number
65533|NCT01153971|Secondary|Percentage of Participants Achieving a Response by Response Type and Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40|ITT population||percentage of participants|||Number
65534|NCT01153971|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)|ITT population||percentage of participants||95% Confidence Interval|Number
65535|NCT01153971|Primary|Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date|Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.|Month 28|ITT population||percentage of participants||95% Confidence Interval|Number
65536|NCT01153958|Secondary|Percentage of Participants Cured|Cure was defined as Nugent score less than 7, no symptoms of vaginal irritation (for example, pain, burning, odour or abnormal vaginal discharge). Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated bacterial vaginosis.|1 week post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.||percentage of participants|||Number
65537|NCT01153958|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 2 months post-treatment|Safety population included all randomized participants who used the investigational product at least once.||participants|||Number
65538|NCT01153958|Secondary|Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment|The grades of Lactobacilli in vaginal discharge were Grade 1 (Normal): Lactobacillus morphotypes predominate; Grade 2 (Intermediate): Mixed flora with some Lactobacilli present, but Gardnerella or Mobiluncus morphotypes also present; Grade 3 (Bacterial Vaginosis): Predominantly Gardnerella and/or Mobiluncus morphotypes, few or absent Lactobacilli.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at the time point.||participants|||Number
65539|NCT01153958|Secondary|Change From Baseline in Nugent Score at 2 Months Post-treatment|Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicate bacterial vaginosis.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'n' signifies those participants who were evaluated for this measure at the time point.||units on a scale||Standard Deviation|Mean
65540|NCT01153958|Secondary|Percentage of Participants With Relapse 1 Month Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|1 month post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.||percentage of participants|||Number
65541|NCT01153958|Primary|Percentage of Participants With Relapse 2 Months Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|2 months post-treatment|Full analysis set (FAS) population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.||percentage of participants|||Number
65542|NCT01153893|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
65543|NCT01153893|Secondary|Number of Subjects Reporting Unsolicited AEs.|Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 31 days (Days 0-30) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
65544|NCT01153893|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).~Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.~Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
65545|NCT01153893|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.~Solicited local symptoms assessed were pain, redness and swelling.~Any = occurrence of any local symptom regardless of intensity grade.~Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)"|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
65546|NCT01153893|Secondary|Concentration of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EL.U/mL).|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
65547|NCT01153893|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A.~Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||Titres||95% Confidence Interval|Geometric Mean
65548|NCT01153893|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||Titres||95% Confidence Interval|Geometric Mean
65549|NCT01153893|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
65550|NCT01153893|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
65551|NCT01153893|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).|"Grade 3 symptom = severe symptom that prevented normal activity.~Solicited local symptoms assessed were pain, redness and swelling.~Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite.~Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
65552|NCT01153815|Secondary|GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points|The care giver or participants used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at the indicated time point.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
65553|NCT01153815|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsenig, -0=unchanged, +4=very marked improvement) at the indicated time points.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
65554|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at the indicated time points was calculated as the value at Weeks 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
65571|NCT01153724|Secondary|Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)|AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
65555|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator, physotherapist, or occupational therapist extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. Only participants with thumb spasticity who received injection in the thumb muscles were evaluated. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
65556|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
65557|NCT01153815|Secondary|Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits|Wrist treatment responders were defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||participants|||Number
65558|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 8, and 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
65559|NCT01153815|Secondary|Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score|The MAS wrist score was assessed by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Mean change from Baseline for the MAS wrist score was calculated as the value at Week 6 and Week 12 minus the value at Baseline. In a graph plotting time points on the horizontal axis (HA) and changes from Baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.||scores on a scale||Standard Deviation|Mean
65560|NCT01153815|Primary|Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.|Baseline (Day 0) and Week 6|Full Analysis Set (FAS) Population: all randomized and treated participants. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.||scores on a scale||Standard Deviation|Mean
65561|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600K Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.|From the first dose to death due to any cause (up to 9.9 months)|Secondary Efficacy Population||Weeks||95% Confidence Interval|Median
65562|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600E Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.|From the first dose of study medication to death due to any cause (up to 9.9 months)|Primary Efficacy Population||Weeks||95% Confidence Interval|Median
65563|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not die or progress, duration of response was censored at the date of last contact.|From the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 29.6 weeks)|Secondary Efficacy Population. Only those participants who had a CR or PR were analyzed.||Weeks||95% Confidence Interval|Median
65572|NCT01153724|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set||ng||Geometric Coefficient of Variation|Geometric Mean
65868|NCT01151579|Primary|Heart Rate in Beats Per Minute|Average difference in Heart rate between pre and post breathing treatments|Five days|Average change in heart rate from baseline to final breathing treatment.||bpm|Participants|Standard Deviation|Mean
65564|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not die, duration of response was censored at the date of last contact.|From the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 31.3 weeks)|Primary Efficacy Population. Only those participants who had a CR ornd PR were analyzed.||Weeks||95% Confidence Interval|Median
65565|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression (PD) or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator/independent reviewer according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). For participants who did not die, PFS was censored at the date of last contact.|From the first dose of study medication to the earliest date of disease progression or death due to any cause (up to 9.9 months)|Secondary Efficacy Population||Weeks||95% Confidence Interval|Median
65566|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression (PD) or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator/independent reviewer according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.|From the first dose of study medication to the earliest date of disease progression or death due to any cause (up to 9.9 months)|Primary Efficacy Population||Weeks||95% Confidence Interval|Median
65567|NCT01153763|Secondary|Number of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment had to have been performed at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later should have been confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. Response was evaluated by an investigator as per RECIST, version 1.1.|From the first dose of study medication until the first documented evidence of a confirmed complete response or partial response (up to 11 weeks)|Secondary Efficacy Population: all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600K mutation||participants|||Number
65568|NCT01153763|Primary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment was required at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later were required to be confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. Response was determined by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to 26.9 weeks)|Primary Efficacy Population: all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600E mutation||participants|||Number
65569|NCT01153724|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS||participants|||Number
65570|NCT01153724|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who had taken at least 1 dose of trial medication.||participants|||Number
65997|NCT01150409|Primary|Incidence of Hypotension Between Study Days 8 and 14 (Within 7 Days of the Initiation of Study Drug).|Study screening/enrollment stopped due to lack of eligible subjects. No outcome measures were analyzed due to the low enrollment.|Day 14||||||
65575|NCT01153724|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
65576|NCT01153724|Primary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
65577|NCT01153711|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS||participants|||Number
65578|NCT01153711|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.||participants|||Number
65579|NCT01153711|Secondary|Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)|AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
65580|NCT01153711|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||ng||Geometric Coefficient of Variation|Geometric Mean
65581|NCT01153711|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Percentage||Geometric Coefficient of Variation|Geometric Mean
65582|NCT01153711|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Hours||Full Range|Median
65583|NCT01153711|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
65584|NCT01153711|Primary|Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)|AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
65585|NCT01153698|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period|Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed.|From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated Set||Number of participants|||Number
65586|NCT01153698|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last Pradaxa intake|Treated Set (All patients with non-missing information for both, the volume drainage until first dose of Pradaxa and the volume drainage from first dose of Pradaxa and onwards).||ml||Standard Deviation|Mean
65587|NCT01153698|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period|Major extra-surgical site bleedings include all major bleedings not occurred at surgical site|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS||Percentage of participants||95% Confidence Interval|Number
65674|NCT01153321|Secondary|IL-8 Concentration in Blood (Pre-LPS Challenge)|IL-8 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65588|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period|"sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.~Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism"|From last enoxaparin administration until first Pradaxa intake|TS reduced to patients with switch period.||Percentage of participants||95% Confidence Interval|Number
65589|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.||Percentage of participants||95% Confidence Interval|Number
65590|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS||Percentage of participants||95% Confidence Interval|Number
65591|NCT01153698|Secondary|Percentage of Patients With MBE During Pre-switch Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.||Percentage of participants||95% Confidence Interval|Number
65592|NCT01153698|Secondary|Percentage of Patients With MBE During Total Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS||Percentage of participants||95% Confidence Interval|Number
65593|NCT01153698|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|TS reduced to patients with switch-/ post-switch period.||Percentage of participants||95% Confidence Interval|Number
65594|NCT01153698|Primary|Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period|Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated set (TS) reduced to patients with switch-/ post-switch period. TS includes all patients who received at least one dose of enoxaparin or at least one dose of Pradaxa.||Percentage of participants||95% Confidence Interval|Number
65595|NCT01153685|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period|The analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
65596|NCT01153685|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort.||Subjects|||Number
65597|NCT01153685|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms.~Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination.~Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination."|Within the 21-day post-vaccination period|The analysis was performed on the Tota Vaccinated Cohort.||Subjects|||Number
65598|NCT01153685|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.|Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)|During a 4-days (Day 0-3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated Cohort on subjects with available results.||Subjects|||Number
65599|NCT01153685|Primary|Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.|Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Fold increase||95% Confidence Interval|Mean
65675|NCT01153321|Secondary|IL-6 Concentration in Blood (Post-LPS Challenge)|IL-6 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65600|NCT01153685|Primary|Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.|A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
65601|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
65602|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
65603|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Titer||95% Confidence Interval|Geometric Mean
65604|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.||Titer||95% Confidence Interval|Geometric Mean
65605|NCT01153672|Secondary|Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to approximately 5 years|||percentage of participants|||Number
65606|NCT01153672|Secondary|Overall Survival|Kaplan-Meier survival curves will be used to describe overall survival. Overall survival time will be censored on the last date the patient was known to be alive.|Time elapsed from the first day of study treatment until death, assessed up to approximately 5 years||||||
65607|NCT01153672|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to describe progression-free survival. For progression-free survival, patients without documented disease progression or death will be treated as censored observations on the date of the last tumor assessment.|Time elapsed from the first day of study treatment, until disease progression or death, assessed up to approximately 5 years||||||
65608|NCT01153672|Primary|Duration of Response|Duration of response will be summarized for responders.|Up to approximately 5 years|||weeks||Full Range|Median
65609|NCT01153672|Primary|Rate of Clinical Benefit According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the response rate and the rate of clinical benefit. The radiological (by computed tomography [CT]) response rate of vorinostat will be determined by tumor measurements assessed by modified RECIST criteria.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) assessed by CT, Clinical Benefit was defined as an objective response (complete response [CR], partial response [PR]) or stable disease [SD]). CR=the disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions."|Up to approximately 5 years|||percentage of evaluable participants||90% Confidence Interval|Number
65610|NCT01153633|Primary|Absolute Change of Target Ulcer From Baseline to Last Visit||12 weeks|per protocol analysis||square centimeters||Standard Error|Least Squares Mean
65611|NCT01153633|Primary|Healing of Target Ulcer atV6/EOS|Number of ulcers healed at V6/EOS|12 weeks|per protocol analysis||ulcers|||Number
65612|NCT01153633|Secondary|Condition of Wound Bed|Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS|12 Weeks|per protocol analysis||percentage of of wound bed||Standard Deviation|Mean
65613|NCT01153633|Secondary|Pain|Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented ‘no pain’ and 100 mm ‘worst possible pain’.|12 Weeks|per protocol analysis||mm||Standard Deviation|Mean
65614|NCT01153633|Secondary|Number of Different Microganisms at V6/EoS||12 Weeks|per protocol analysis||Number of microgasism species||Standard Deviation|Mean
65615|NCT01153633|Primary|Percent Change of Wound Size From Baseline to Last Visit||12 Weeks|Per protocol set||percentage change in wound size (cm2)||Standard Error|Least Squares Mean
65616|NCT01153620|Secondary|Comparison of the Percentage of Patients With Target Wounds <50 CFU|Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application|60 minutes||||||
65617|NCT01153620|Secondary|Reduction in CFU|Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application|15 minutes, 30 minutes and 60 minutes||||||
65618|NCT01153620|Secondary|Local Tolerability: Pruritis Burning|Local tolerability after 60 minutes of treatment application.|60 minutes||||||
65619|NCT01153620|Primary|Reduction (log10) in Colony Forming Units|Comparison of the log10 reduction in CFU after 60 minutes of treatment application.|60 minutes|ITT population: comprising all wounds having received the study treatment for any duration (n=61).||log 10 Colony Forming Units|Participants|Standard Deviation|Mean
65620|NCT01153581|Primary|Skin Microvascular Responses|"Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as “% max. This is measured with a Laser Doppler probes, which measures volts."|2 months|Women with and without orthostatic intolerance||Percent of max volts||Standard Error|Mean
65676|NCT01153321|Secondary|IL-6 Concentration in Blood (Pre-LPS Challenge)|IL-6 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65621|NCT01153581|Primary|Baroreceptor Function|"This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.~Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg."|2 months|Women with low and high orthostatic tolerance||ms/mm Hg||Standard Error|Mean
65622|NCT01153581|Primary|Orthostatic Tolerance|We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.|2 months|||mmHg*min||Standard Deviation|Mean
65623|NCT01153503|Primary|Morphine Consumption|Morphine consumption over the first 24 hours|24 hours post surgery|||mg||Standard Deviation|Mean
65624|NCT01153347|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11- point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65625|NCT01153347|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65626|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65627|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Q LES-Q-SF)Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65628|NCT01153347|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65629|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65630|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65631|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65632|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65633|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65634|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65635|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65636|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65637|NCT01153347|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale, the total score can range from 0 to 56. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)|||units on a scale||Standard Error|Least Squares Mean
65638|NCT01153347|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65639|NCT01153347|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65640|NCT01153347|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
97740|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
65641|NCT01153347|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65642|NCT01153347|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of patients analyzed|||Number
65643|NCT01153347|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65644|NCT01153347|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65645|NCT01153347|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||percentage of participants analyzed|||Number
65646|NCT01153347|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.||units on a scale||Standard Error|Least Squares Mean
65647|NCT01153321|Secondary|CC16 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
65648|NCT01153321|Secondary|Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)||up to 47 days (visit 1 to visit 6)|||Participants|||Number
65649|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Physical Examination||up to 47 days (visit 1 to visit 6)|||Participants|||Number
65650|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables||up to 47 days (visit 1 to visit 6)|||Participants|||Number
65651|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||up to 47 days (visit 1 to visit 6)|||Participants|||Number
65652|NCT01153321|Secondary|Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes||up to 47 days (visit 1 to visit 6)|||Participants|||Number
65653|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||nmol*h/L||Full Range|Geometric Mean
65654|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||nmol*h/L||Full Range|Geometric Mean
65655|NCT01153321|Secondary|Time to Cmax (Tmax) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||hours||Full Range|Median
65656|NCT01153321|Secondary|Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State|Steady state pharmacokinetic (PK) profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.||nmol/L||Full Range|Geometric Mean
65657|NCT01153321|Secondary|Neutrophils in Blood (Post-LPS Challenge)|Neutrophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65658|NCT01153321|Secondary|Neutrophils in Blood (Pre-LPS Challenge)|Neutrophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65659|NCT01153321|Secondary|Monocytes in Blood (Post-LPS Challenge)|Monocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65660|NCT01153321|Secondary|Monocytes in Blood (Pre-LPS Challenge)|Monocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65661|NCT01153321|Secondary|Lymphocytes in Blood (Post-LPS Challenge)|Lymphocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65662|NCT01153321|Secondary|Lymphocytes in Blood (Pre-LPS Challenge)|Lymphocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65663|NCT01153321|Secondary|Eosinophils in Blood (Post-LPS Challenge)|Eosinophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65664|NCT01153321|Secondary|Eosinophils in Blood (Pre-LPS Challenge)|Eosinophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65665|NCT01153321|Secondary|Basophils in Blood (Post-LPS Challenge)|Basophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65666|NCT01153321|Secondary|Basophils in Blood (Pre-LPS Challenge)|Basophils in blood pre-LPS challenge (Day 10)|day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65667|NCT01153321|Secondary|CC16 Concentration in Blood (Post-LPS Challenge)|CC16 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.||ng/mL||Standard Error|Least Squares Mean
65668|NCT01153321|Secondary|CC16 Concentration in Blood (Pre-LPS Challenge)|CC16 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Three patients had missing observations.||ng/mL||Standard Error|Least Squares Mean
65669|NCT01153321|Secondary|SP-D Concentration in Blood (Post-LPS Challenge)|SP-D concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
65670|NCT01153321|Secondary|SP-D Concentration in Blood (Pre-LPS Challenge)|SP-D concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
65677|NCT01153321|Secondary|IL-1β Concentration in Blood (Post-LPS Challenge)|IL-1β concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65678|NCT01153321|Secondary|IL-1β Concentration in Blood (Pre-LPS Challenge)|IL-1β concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65679|NCT01153321|Secondary|CCL2 Concentration in Blood (Post-LPS Challenge)|CCL2 concentration in blood post-LPS challenge (Day 11).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65680|NCT01153321|Secondary|CCL2 Concentration in Blood (Pre-LPS Challenge)|CCL2 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||pg/mL||Standard Error|Least Squares Mean
65681|NCT01153321|Secondary|SAA Concentration in Blood (Post-LPS Challenge)|SAA concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
65682|NCT01153321|Secondary|SAA Concentration in Blood (Pre-LPS Challenge)|SAA concentration in blood pre-LPS challenge (Day 10).|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||ng/mL||Standard Error|Least Squares Mean
65683|NCT01153321|Secondary|SP-D Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||ng/mL||Standard Error|Least Squares Mean
65684|NCT01153321|Secondary|RANTES Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
65685|NCT01153321|Secondary|IL-8 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
65686|NCT01153321|Secondary|IL-6 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
65687|NCT01153321|Secondary|IL-1β Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
65688|NCT01153321|Secondary|CCL2 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
65689|NCT01153321|Secondary|TNF α Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.||pg/mL||Standard Error|Least Squares Mean
65690|NCT01153321|Secondary|Macrophages in BAL (Post-LPS Challenge)|Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Deviation|Least Squares Mean
65691|NCT01153321|Secondary|Neutrophils in BAL (Post-LPS Challenge)|Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65986|NCT01150474|Secondary|Satisfaction With Pain Relief|"Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being very dissatisfied, and 10 being very satisfied."|Approximately 24 hours following surgery|||units on a scale||Standard Deviation|Mean
65692|NCT01153321|Secondary|Lymphocytes in BAL (Post-LPS Challenge)|Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65693|NCT01153321|Secondary|Eosinophils in BAL (Post-LPS Challenge)|Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.||x10^4 cells/mL||Standard Error|Least Squares Mean
65694|NCT01153321|Secondary|Biopsy Epithelium Grade (Post-LPS Challenge)|Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.||Units on a scale||Standard Error|Least Squares Mean
65695|NCT01153321|Secondary|Biopsy PAS Reaction Grade (Post-LPS Challenge)|Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.||Units on a scale||Standard Error|Least Squares Mean
65696|NCT01153321|Secondary|CD3+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
65697|NCT01153321|Secondary|CD45+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
65698|NCT01153321|Secondary|Total Macrophages in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
65699|NCT01153321|Secondary|Total Neutrophils in Biopsy Sample (Post-LPS Challenge)|Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.||cells/mm^2||Standard Error|Least Squares Mean
65700|NCT01153321|Primary|Absolute Monocyte Count in BAL Post-LPS Challenge|Monocyte count in BAL post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge||x10^4 cells/mL||Standard Error|Least Squares Mean
65701|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.|Week 144|All participants with CD4+ cell count measurements at Week 144 are included.||CD4+ cells/μL||Standard Deviation|Mean
65702|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.|Week 132|All participants with CD4+ cell count measurements at Week 132 are included.||CD4+ cells/μL||Standard Deviation|Mean
65703|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.|Week 120|All participants with CD4+ cell count measurements at Week 120 are included.||CD4+ cells/μL||Standard Deviation|Mean
65704|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.|Week 108|All participants with CD4+ cell count measurements at Week 108 are included.||CD4+ cells/μL||Standard Deviation|Mean
65705|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.|Week 96|All participants with CD4+ cell count measurements at Week 96 are included.||CD4+ cells/μL||Standard Deviation|Mean
65706|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.|Week 84|All participants with CD4+ cell count measurements at Week 84 are included.||CD4+ cells/μL||Standard Deviation|Mean
65987|NCT01150474|Secondary|Number of Subjects Who Used Antiemetic Rescue Medications||First 24 hours after surgery|||participants|||Number
65707|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.|Week 72|All participants with CD4+ cell count measurements at Week 72 are included.||CD4+ cells/μL||Standard Deviation|Mean
65708|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.|Week 60|All participants with CD4+ cell count measurements at Baseline are included.||CD4+ cells/μL||Standard Deviation|Mean
65709|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.|Week 48|All participants with CD4+ cell count measurements at Week 48 are included.||CD4+ cells/μL||Standard Deviation|Mean
65710|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.|Week 36|All participants with CD4+ cell count measurements at Week 36 are included.||CD4+ cells/μL||Standard Deviation|Mean
65711|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.|Week 24|All participants with CD4+ cell count measurements at Week 24 are included.||CD4+ cells/μL||Standard Deviation|Mean
65712|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.|Week 12|All participants with CD4+ cell count measurements at Week 12 are included.||CD4+ cells/μL||Standard Deviation|Mean
65713|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.|Week 4|All participants with CD4+ cell count measurements at Week 4 are included.||CD4+ cells/μL||Standard Deviation|Mean
65714|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.|Baseline|All participants with CD4+ cell count measurements at Baseline are included.||CD4+ cells/μL||Standard Deviation|Mean
65715|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with HIV-1 RNA results at Week 144.||log10 copies/mL||Standard Deviation|Mean
65716|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with HIV-1 RNA results at Week 132.||log10 copies/mL||Standard Deviation|Mean
65717|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with HIV-1 RNA results at Week 120.||log10 copies/mL||Standard Deviation|Mean
65718|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with HIV-1 RNA results at Week 108.||log10 copies/mL||Standard Deviation|Mean
65719|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with HIV-1 RNA results at Week 96.||log10 copies/mL||Standard Deviation|Mean
65720|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with HIV-1 RNA results at Week 84.||log10 copies/mL||Standard Deviation|Mean
65721|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with HIV-1 RNA results at Week 72.||log10 copies/mL||Standard Deviation|Mean
65722|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with HIV-1 RNA results at Week 60.||log10 copies/mL||Standard Deviation|Mean
65723|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with HIV-1 RNA results at Week 48.||log10 copies/mL||Standard Deviation|Mean
65724|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with HIV-1 RNA results at Week 36.||log10 copies/mL||Standard Deviation|Mean
65725|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with HIV-1 RNA results at Week 24.||log10 copies/mL||Standard Deviation|Mean
65988|NCT01150474|Secondary|Number of Times Antiemetic Rescue Medication Was Used||First 24 hours after surgery|||number of times antiemetics used||Standard Deviation|Mean
65726|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with HIV-1 RNA results at Week 12.||log10 copies/mL||Standard Deviation|Mean
65727|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with HIV-1 RNA results at Week 4.||log10 copies/mL||Standard Deviation|Mean
65728|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with HIV-1 RNA results at Baseline.||log10 copies/mL||Standard Deviation|Mean
65729|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144.||U/liter||Standard Deviation|Mean
65730|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132.||U/liter||Standard Deviation|Mean
65731|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120.||U/liter||Standard Deviation|Mean
65732|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108.||U/liter||Standard Deviation|Mean
65733|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96.||U/liter||Standard Deviation|Mean
65734|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84.||U/liter||Standard Deviation|Mean
65735|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72.||U/liter||Standard Deviation|Mean
65736|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60.||U/liter||Standard Deviation|Mean
65737|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48.||U/liter||Standard Deviation|Mean
65738|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36.||U/liter||Standard Deviation|Mean
65739|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.||U/liter||Standard Deviation|Mean
65740|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.||U/liter||Standard Deviation|Mean
65989|NCT01150474|Secondary|Number of Subjects With Vomiting|This information was taken from the medical record.|Within 20 hours of surgery|||participants|||Number
65741|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.||U/liter||Standard Deviation|Mean
65742|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.||U/liter||Standard Deviation|Mean
65743|NCT01153009|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
65744|NCT01153009|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
65745|NCT01153009|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
65746|NCT01153009|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
65747|NCT01153009|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.||percentage of participants|||Number
65748|NCT01153009|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
65749|NCT01152996|Secondary|Change From Baseline in SDS Family Life/Home Responsibilities Subscale|The change between the Sheehan Disability family life/home responsibilities subscale score at each assessed visit and family life/home responsibilities subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
65750|NCT01152996|Secondary|Change From Baseline in SDS Social Life Subscale|The change between the Sheehan Disability social life subscale score at each assessed visit and social life subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
65990|NCT01150474|Secondary|Number of Subjects With Nausea|This information was taken from the medical record.|Approximately 12 hours after surgery|||participants|||Number
65751|NCT01152996|Secondary|Change From Baseline in SDS Work/School Subscale|The change between the Sheehan Disability work/school subscale score at each assessed visit and work/school subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
65752|NCT01152996|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The change between the SDS total score at each assessed visit and the total score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
65753|NCT01152996|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|"The change between CGI-S score at each assessed visit and CGI-S score at baseline. The CGI-S assesses the clinician’s impression of the subject’s current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill). Higher scores indicate greater severity of illness."|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
65754|NCT01152996|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The change between HAM-A score at each assessed visit and HAM-A score at baseline. HAM-A is a 14 item rating scale to quantify anxiety symptomatology severity (i.e., anxious mood, tension, fear, insomnia, etc.) rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
65755|NCT01152996|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The change between MADRS total score at each assessed visit and MADRS score at baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52|Safety set, observed cases (OC)||units on a scale||Standard Deviation|Mean
65756|NCT01152996|Primary|Treatment-Emergent Adverse Events Leading to Study Discontinuation|Treatment-emergent adverse events are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set||participants|||Number
65757|NCT01152996|Primary|Number of Participants With Serious Treatment-Emergent Adverse Events|Serious treatment-emergent adverse events (serious-TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A serious-TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered serious adverse events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|Over the 52 week period|Safety set||participants|||Number
65758|NCT01152996|Primary|Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set||participants|||Number
65759|NCT01152814|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using the PP dataset.||Percentage of participants||95% Confidence Interval|Number
65760|NCT01152814|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using the PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
65761|NCT01152814|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis.||Number of participants|||Number
65786|NCT01152697|Primary|Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks|Subjects will be asked how many days they have been homeless|Baseline-25 weeks|26 participants were asked how many days they were homeless at week 25. Only data for these participants was analyzed for change from baseline to week 25.||days||Standard Deviation|Mean
65762|NCT01152814|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violation.||Percentage of participants||95% Confidence Interval|Number
65763|NCT01152788|Secondary|Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)|To determine the safety and toxicity profile of rIL-21 and dacarbazine in patients with chemotherapy and immunotherapy-naive metastatic or recurrent malignant melanoma. Adverse events were measured according to the Common Terminology Criteria version 4.0 for Adverse Events. Number of patients with worst adverse event of grade 3 4 or 5 were counted for both rIL-21 and Dacarbazine arms.|Over study period, up to 22 months|||participants|||Number
65764|NCT01152788|Secondary|Overall Survival|For patients who have died, overall survival is calculated in months from the day of randomization to date of death. Otherwise, survival is censored at the last day the patient is known alive.|From randomization to death of any cause, up to 22 months|||months||95% Confidence Interval|Median
65765|NCT01152788|Secondary|Response Rate|Tumour response is defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes must have short axis measures < 10 mm (Note: continue to record the measurement even if < 10 mm and considered CR). Residual lesions (other than nodes < 10 mm) thought to be non-malignant should be further investigated (by cytology or PET scans) before CR can be accepted. Confirmation of complete response is not required in this randomized study. Partial Response (PR): At least a 30% decrease in the sum of measures (longest diameter for tumour lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Confirmation of partial response is not required in this randomized study. Overall Response (OR) = CR + PR.|From the start of study treatment until the end of treatment (before disease progression)|||percentage of participants||95% Confidence Interval|Number
65766|NCT01152788|Primary|Progression Free Survival|Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.|From randomization to progression or death, up to 22 months|treated population||years||95% Confidence Interval|Median
65767|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|12 months|Seven participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
65768|NCT01152697|Secondary|Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes.|12 months|Six participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
65769|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|12 months|Six participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
65770|NCT01152697|Secondary|Treatment Adherence Score as Measured at 12 Months|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|12 months|Seven participants were administered and completed this measure at 12 months.||Percentage of doses||Standard Deviation|Mean
65771|NCT01152697|Secondary|Days Homeless Out of the Previous 6 Months as Measured at 12 Months|Subjects will be asked how many days they have been homeless|12 months|Six participants were administered and completed this measure at 12 months.||days||Standard Deviation|Mean
65772|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months|"Satisfaction will be measured by a seven item inventory taken by the participant.~Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|12 months|Six participants were administered and completed this measure at 12 months.||units on a scale||Standard Deviation|Mean
65773|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-12 months|Six participants were administered and completed measurement with the SOFAS at 12 months. Only data for these participants was analyzed for change from baseline to 12 months.||units on a scale||Standard Deviation|Mean
65785|NCT01152697|Primary|Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|Baseline-25 weeks|17 participants were administered and completed measurement of their Treatment Adherence scores at week 25. Only data for these participants was analyzed for change from baseline to week 25.||Percentage of doses||Standard Deviation|Mean
65774|NCT01152697|Secondary|Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.~Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|12 months|12 participants were administered and completed measurement with the CGI at 12 months.||units on a scale||Standard Deviation|Mean
65775|NCT01152697|Secondary|Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks|The frequency of health resource use will be measured through interview of the participant.|25 weeks|17 participants were administered and completed this measure at week 25.||days||Standard Deviation|Mean
65776|NCT01152697|Secondary|Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks|"The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness.~There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes.~Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the PANSS at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
65777|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks|"Satisfaction will be measured by a seven item inventory taken by the participant.~Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|25 weeks|17 participants were administered and completed this measure at week 25.||units on a scale||Standard Deviation|Mean
65778|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-25 weeks|17 participants were administered and completed measurement with the SOFAS at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
65779|NCT01152697|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.~Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|Baseline-25 weeks|17 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change at week 25.||units on a scale||Standard Deviation|Mean
65780|NCT01152697|Secondary|Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks|"The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87.~Scale Range: 18-126 Lower scores represent improved outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the BPRS at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
65781|NCT01152697|Secondary|Frequency of Health Resource Use Throughout Months 10, 11, and 12|The frequency of health resource use will be measured through interview of the participant.|Month 1-3, Month 10-12|Three participants were administered and completed this measurement at 12 months. Only data for these participants was analyzed for changes.||days||Standard Deviation|Mean
65782|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|Baseline-25 weeks|19 participants were administered and completed measurement with the AMQ at week 25. Only data for these participants was analyzed for change from baseline to week 25. Lower scores indicate improved outcomes.||units on a scale||Standard Deviation|Mean
65783|NCT01152697|Primary|Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Baseline-25 weeks|16 participants were administered and completed measurement with the Morisky Medication Rating Scale at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
65784|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Baseline-25 weeks|15 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change from baseline to week 25.||units on a scale||Standard Deviation|Mean
65991|NCT01150474|Secondary|Narcotic Rescue Medication|Use of all ancillary narcotic medications was taken from the medical record.|For 24 hours following surgery|||mg IV morphine equivalents||Standard Deviation|Mean
65787|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in the Pittsburgh Sleep Quality Index (PSQI) in Women After 6 Months, as Compared to Baseline.|"Pittsburgh Sleep Quality Index (PSQI) Questionnaire is a validated questionnaire that assesses the quality and quantity of sleep and sleep disorders.This survey is designed to identify “good” and “poor” sleepers and has a score scale that ranges from 0-21 with 0 being good quality of sleep and 21 being poor quality of sleep and/or indicating as having a sleep disorder. A more positive mean change in the PSQI over time indicates a worsening of sleep. A more negative mean change in the PSQI over time indicates an improvement in sleep."|Baseline and 6 months|intention to treat||units on a scale||Standard Deviation|Mean
65788|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Sexual Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
65789|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Bone Density in Women After 6 Months, as Compared to Baseline.|The mean change in bone mineral density (BMD), represented by T-scores, was assessed by calcaneal ultrasound in women taking melatonin (3 mg) or placebo nightly at baseline and after 6 months. A T-score is a comparison of a subject's BMD to that of a healthy 30 year old female of the same ethnicity. The more negative the T-score, the worse the BMD. Osteoporosis or brittle bone disease is defined as a T-score -2.5 or less. A more negative mean change in a T-score would indicate a worsening of BMD. A more positive mean change in a T-score would indicate an improvement of BMD.|Baseline and 6 months|intention to treat||T-score||Standard Deviation|Mean
65790|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Psychosocial Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
65791|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Type-1 Collagen Cross-linked N-telopeptide (NTX) Levels in Women After 6 Months, as Compared to Baseline.|Type-1 collagen cross-linked N-telopeptide (NTX) levels were measured in the serum of women at baseline and after taking placebo or melatonin (3 mg) nightly for 6 months. NTX, reported as bone collagen equivalents (BCE), is released from bone due to the actions of osteoclasts or bone breakdown cells. A more positive mean change in NTX levels (6 months - baseline) could result in a worsening of bone mineral density due to an increase in bone breakdown whereas a more negative mean change in NTX levels could result in an improvement in bone mineral density due to a decrease in bone breakdown.|Baseline and 6 months|intention to treat||nM BCE||Standard Deviation|Mean
65792|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Vasomotor Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
65793|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Physical Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat||units on a scale||Standard Deviation|Mean
65794|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline|Osteocalcin is a measure of osteoblast activity because it is secreted from osteoblasts. Osteocalcin levels were measured in the serum of women at baseline and after 6 months of taking placebo or melatonin (3 mg) and the data are reported as ng/mL. Osteoblasts are bone-forming cells so a more positive mean change in osteoblast activity over time (6 months - baseline) could indicate an improvement in bone mineral density. A more negative mean change in osteocalcin levels over time (6 months - baseline) could indicate a worsening of bone mineral density.|Baseline and 6 months|intention to treat||ng/mL||Standard Deviation|Mean
65804|NCT01152450|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Assessed by the patient's electronic diary (eDiary incorporated in the AM2+ device), obtained during the last week of each period of randomised treatment.|Baseline and during week 4|FAS||Night awakenings||Standard Error|Mean
65805|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS||Puffs||Standard Error|Mean
65795|NCT01152554|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
65796|NCT01152554|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
65797|NCT01152554|Secondary|Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
65798|NCT01152554|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||units on a scale||Standard Deviation|Mean
65799|NCT01152554|Secondary|Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52|"The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 52|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||percentage of patients analyzed|||Number
65800|NCT01152554|Secondary|Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24|"The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 24|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.||percentage of participants analyzed|||Number
65801|NCT01152554|Primary|Frequency of Patients Experiencing Serious Adverse Events (SAEs)|The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.||percentage of participants analyzed|||Number
65802|NCT01152554|Primary|Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.||percentage of participants analyzed|||Number
65803|NCT01152554|Primary|Frequency of Patients Experiencing at Least One Adverse Event (AE)|The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.||percentage of participants analyzed|||Number
65806|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS||Puffs||Standard Error|Mean
65807|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS||Puffs||Standard Error|Mean
65808|NCT01152450|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent (weekly means obtained during the last week of each period of randomised treatment will be compared).|Baseline and during week 4|FAS||Percent||Standard Error|Mean
65809|NCT01152450|Secondary|PEF Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres/min.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L/min||Standard Error|Mean
65810|NCT01152450|Secondary|FVC Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
65811|NCT01152450|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS||L/min||Standard Error|Mean
65812|NCT01152450|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
65813|NCT01152450|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
65814|NCT01152450|Secondary|Peak FVC Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
65815|NCT01152450|Secondary|FVC Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
65816|NCT01152450|Secondary|FVC Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
65817|NCT01152450|Secondary|Trough Forced Vital Capacity (FVC) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FVC is defined as FVC value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
65818|NCT01152450|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 is defined as FEV1 value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
65819|NCT01152450|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the evening trial-drug inhalation at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS||L||Standard Error|Mean
65820|NCT01152450|Secondary|FEV1 Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
65821|NCT01152450|Secondary|FEV1 Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS||L||Standard Error|Mean
65822|NCT01152450|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS||L/min||Standard Error|Mean
65858|NCT01151761|Secondary|Median Time to Overall Survival|The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.|18 months|||months||95% Confidence Interval|Median
65823|NCT01152450|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS||L/min||Standard Error|Mean
65824|NCT01152450|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response|Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measurements performed in relation to evening dosing. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|Full Analysis Set (FAS) defined as all treated patients who had baseline data and at least 1 on-treatment efficacy measurement after 4 weeks on treatment within a period.||L||Standard Error|Mean
65825|NCT01152437|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)|Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.|day 8|Randomised set for wild-type group and treated set for mutated group.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
65826|NCT01152437|Secondary|Overall Survival (OS) Time|OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till death, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.||Days||95% Confidence Interval|Median
65827|NCT01152437|Secondary|Progression Free Survival (PFS)|PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.||Days||95% Confidence Interval|Median
65828|NCT01152437|Primary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Treated Set. Primary endpoint for the population of patients with KRAS mutated tumours.||Percentage of Participants||90% Confidence Interval|Number
65829|NCT01152437|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set. Primary endpoint for the population of patients with KRAS wildtype tumours.||Percentage of Participants|||Number
65830|NCT01152385|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||mg/dL||Standard Deviation|Mean
65831|NCT01152385|Secondary|Percentage Change in Triglycerides||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
65832|NCT01152385|Secondary|Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
65833|NCT01152385|Secondary|Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
65834|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 6.5%||at 4th month|The analysis population was prior to rescue treatment (FAS)||Participants|||Number
65835|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 7%||at 4th month|The analysis population was prior to rescue treatment (FAS)||Participants|||Number
65836|NCT01152385|Secondary|Change in Fasting Plasma Glucose (FPG)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||mg/dL||Standard Deviation|Mean
65837|NCT01152385|Primary|Change in Haemoglobin A1c (HbA1c)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)||Percentage||Standard Deviation|Mean
65838|NCT01152359|Secondary|Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire||48 weeks||||||
65839|NCT01152359|Secondary|Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)||48 weeks||||||
65840|NCT01152359|Primary|Body Weight||48 weeks|||percentage of weight change||95% Confidence Interval|Mean
65841|NCT01152307|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs|2 weeks, on average||||||
65842|NCT01152307|Primary|Depression Knowledge|Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).|2 weeks, on average|Participants were randomized to receive the DVD and booklet.||percent of correct responses||Standard Deviation|Mean
65843|NCT01152294|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs|2 weeks, on average||||||
65844|NCT01152294|Primary|Menopause Knowledge|Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)|2 weeks, on average|Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.||Percentage (0-100%)||Standard Deviation|Mean
65859|NCT01151761|Secondary|Liver Transplant Conversion Rate|The ability to successfully perform liver transplant among patients who initially have tumor >3 cm|12 months|||participants|||Number
65860|NCT01151761|Secondary|Freedom From Local Progression at 12 Months|the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk|12 months|Neither of the two patients that participated in the study had a local recurrence prior to dying.||percentage of patients|||Number
65845|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck|CPI quantified blood flow in a pre-specified region of interest by using color Doppler imaging. CPI was the mean color pixel intensity in the region of interest and scores could range from 0 to 160. An increase in CPI reflected an increase in blood flow. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
65846|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.||ratio||Standard Error|Least Squares Mean
65847|NCT01152190|Secondary|Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.||ratio||Standard Error|Least Squares Mean
65848|NCT01152190|Primary|Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 8|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.||ratio||Standard Error|Least Squares Mean
65849|NCT01151904|Secondary|Percentage of Responders With an IOP Reduction ≥20% From Baseline|IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.|||||
65850|NCT01151904|Secondary|Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 2, Week 6|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.|||||
65851|NCT01151904|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.|||||
65852|NCT01151852|Secondary|Safety and Tolerability of Imatinib|percentage of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of imatinib re-challenge in this patient population|Up to 3years|||percentage of participants|||Number
65853|NCT01151852|Secondary|Overall Survival(OS) and Time to Progression(TTP)|To compare the overall survival (OS) and time to progression (TTP) in both arms of the study|Up to 3years|||Months||95% Confidence Interval|Median
65854|NCT01151852|Secondary|Response Rate|"Tumour responses were initially determined by the local investigators in accordance with RECIST 1.0.Treatment decisions were based on local onsite radiological review. All imaging data were subsequently collected, anonymised, and reviewed centrally in a double-blind manner by two external academic radiology reviewers.~Response assessment was determined in a masked central review by use of RECIST1.1."|Up to 12weeks|||percentage of participants|||Number
65855|NCT01151852|Secondary|Progression Free Survival|To compare PFS assessed by investigators|up to 12 weeks|||Months||95% Confidence Interval|Median
65856|NCT01151852|Secondary|Disease Control Rate|"Inclusion of complete response, partial response or stable disease~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD."|up to 12 weeks|||percentage of participants|||Number
65857|NCT01151852|Primary|Progression-free Survival|To compare the progression free survival (PFS) assessed by the blinded independent central review following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with unresectable or metastatic GIST following failure of at least prior imatinib and sunitinib therapies|up tp12 weeks|||Months||95% Confidence Interval|Median
65869|NCT01151553|Primary|Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome|Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve|One year|Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.|||||
65870|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65871|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65872|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65873|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65874|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65875|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65876|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65877|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65878|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65879|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65880|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65881|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65882|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65883|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|ININTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65884|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65885|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65886|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65887|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
98594|NCT00827632|Secondary|Possible Changes in Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users.||Screening and follow-up 1||||||
65888|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65889|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65890|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Error|Mean
65891|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65892|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65893|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale||Standard Deviation|Mean
65894|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale||Standard Error|Mean
65895|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale|Participants|Standard Deviation|Mean
65896|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)||units on a scale||Standard Deviation|Mean
65897|NCT01151410|Secondary|Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP-­DBP).|Baseline to end of study (Week 52 or LOCF)|Full analysis set (FAS) included all randomized patients for this trial||mmHg||Standard Error|Least Squares Mean
65898|NCT01151410|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial||mmHg||Standard Error|Least Squares Mean
65899|NCT01151410|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial||millimeter(s) of mercury (mmHg)||Standard Error|Least Squares Mean
65900|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B|Redness scale of 0 to 4, where 0=None, and 4=Severe.|After 4 Weeks|||units on a scale|Participants|Standard Deviation|Mean
65901|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.|After 4 Weeks|||units on a scale||Standard Error|Mean
65902|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B|Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort|After 4 Weeks|||units on a scale||Standard Error|Mean
65903|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks|||units on a scale||Standard Deviation|Mean
65904|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B|Scale of 0 to 3, where 0=none and 3=severe staining.|After 4 Weeks|||units on a scale||Standard Deviation|Mean
65905|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.|After 1 Week|||units on a scale||Standard Error|Mean
65906|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A|Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort|After 1 Week|||units on a scale||Standard Error|Mean
65992|NCT01150474|Secondary|Pain at Hour 20|"Pain at 20 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|20 hours after surgery.|||units on a scale||Standard Deviation|Mean
65907|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 Week|||units on a scale||Standard Deviation|Mean
65908|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A|Standard scale of 0 to 3 where 0=None, 3=Severe staining|After 1 Week|||units on a scale|Participants|Standard Deviation|Mean
65909|NCT01151371|Primary|Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks|||units on a scale||Standard Deviation|Mean
65910|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A|Redness scale of 0 to 4, where 0=None, 4=Severe redness|After 1 Week|||Units on a scale|Participants|Standard Deviation|Mean
65911|NCT01151371|Primary|Overall Comfort Narafilcon B v. Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 week|||units on a scale||Standard Deviation|Mean
65912|NCT01151345|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
65913|NCT01151345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
65914|NCT01151345|Primary|Maximum Observed Plasma Concentration (Cmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Mean
65915|NCT01151345|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Mean
65916|NCT01151345|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Mean
65917|NCT01151280|Secondary|Time to Stent Occlusion|"Evidence of stent occlusion~stent occlusion was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data."|mean time from stent placement to stent removal for all 10 patients was 91.3 days.|"All participants were included for analysis.~1/10 subjects experienced stent occlusion at 68 days post stent placement. Mean time to event data was not calculated as only 1 stent occlusion occurred in 10 subjects."||days|||Number
65918|NCT01151280|Secondary|Re-intervention Occurrence|Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.|6 months post stent removal|All participants were included for analysis.||participants|||Number
65919|NCT01151280|Secondary|Effectiveness of Stent at 6 Months|"Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram.~Effectiveness is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent.~Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms."|From stent removal through 6 months post stent removal follow-up.|Effectiveness was assessed in 9 participants that had stricture resolution at the time of stent removal. 1 participant did not have resolution at removal and therefore could not be assessed in the post stent removal follow-up period.||participants|||Number
65920|NCT01151280|Secondary|Technical Success of Stent Placement|Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.|At stent placement (Day 1)|All participants were included for analysis.||participants|||Number
65921|NCT01151280|Secondary|Stent Removability|Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.|At 3 months (per protocol removal) or early removal|All participants were included for analysis.||participants|||Number
65922|NCT01151280|Secondary|Safety|"Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal.~Unit of measure will be the actual number of adverse events that occurred."|From enrollment through end of study.|All participants were included for analysis.||adverse events|||Number
65923|NCT01151280|Primary|Stricture Resolution at the Time of Stent Removal.|Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.|At 3 months (per protocol removal) or at early removal.|All participants were included for analysis.||participants|||Number
65924|NCT01151215|Secondary|Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone|Time from the date of randomization to the date of death (by any cause)|Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.||Months|Participants|Inter-Quartile Range|Median
65925|NCT01151215|Primary|Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.|Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.||Months|Participants|Inter-Quartile Range|Median
65926|NCT01151189|Secondary|QuantiFERON (QFN) Conversion Rate in MVA85A/AERAS-485 Recipients Compared to Control Subjects Without a Diagnosis of Tuberculosis During the Trial.||For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:~All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0 (QFT negative at baseline subgroup)."||participants who converted|||Number
65927|NCT01151189|Secondary|Immunogenicity of MVA85A/AERAS-485 Compared to Placebo as Described by Flow Cytometric Intracellular Cytokine Staining (ICS) of CD4+ and CD8+ T Cells After Stimulation With a Peptide Pool of Mycobacterial Antigens.|The antigen-specific negative control-subtracted response for any cytokine (Interferon gamma [INFγ] , Interleukin 2 [IL2], Interleukin 17 [IL17] and tumor necrosis factor [TNF]).|7 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.||Percent responding TCells||95% Confidence Interval|Median
65928|NCT01151189|Secondary|Counts of Spot-forming Units After Stimulation With AG85A Peptide Pool.|Immunogenicity of MVA85A/AERAS-485 compared to placebo as described by the ex vivo interferon (IFN)-γ enzyme linked immunospot (ELISpot).|28 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.||SFU - background/10^6 PBMC||95% Confidence Interval|Median
65929|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Participants.||Up tp 6 months post second vaccination|"Safety:~All randomized ART + subjects who received a dose of study vaccine, based on actual treatment received."||copies/mL||Standard Deviation|Geometric Mean
65930|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART - Participants||Up to 6 months post second vaccination.|"Safety:~All randomized ART - subjects who received a dose of study vaccine, based on actual treatment received."||copies/mL||Standard Deviation|Geometric Mean
65931|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Subjects||Up to 6 months post second vaccination.|"Safety:~All randomized ART positive subjects who received a dose of study vaccine, based on actual treatment received."||cells/mm^3||Standard Deviation|Geometric Mean
65932|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in Anti-retroviral Therapy Negative (ART -)Subjects||Up to 6 months post second vaccination.|"Safety:~All randomized ART negative subjects who received a dose of study vaccine, based on actual treatment received."||cells/mm^3||Standard Deviation|Geometric Mean
65933|NCT01151189|Secondary|Number of TB Cases|Efficacy of MVA85A/AERAS-485 in the prevention of TB disease compared to control subjects who received placebo in HIV-infected, African adult subjects without active TB disease.|For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:~All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0."||participants with TB|||Number
65934|NCT01151189|Primary|Percentage of Participants With Adverse Events|The primary objective of this study is to evaluate the safety of MVA85A/AERAS-485 compared to placebo in HIV-infected, African adult subjects without active TB disease.|Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.|"Safety:~All randomized subjects who received a dose of study vaccine, based on actual treatment received."||percentage of participants with an AE|||Number
65935|NCT01151137|Other Pre-specified|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|Safety population: all randomized and treated participants. Participants were considered according to the treatment actually received. Consequently the participant randomized to the placebo group who received Dronedarone was included in the Dronedarone group.||participants|||Number
65936|NCT01151137|Other Pre-specified|Overview of Cardiovascular Events||From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||participants|||Number
65993|NCT01150474|Secondary|Pain at Hour 12|"Pain at 12 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|12 hours after surgery.|||units on a scale||Standard Deviation|Mean
65937|NCT01151137|Secondary|Time to Cardiovascular Death (Cumulative Incidence Function)|"Time to cardiovascular death was defined as the time from randomization to the death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||proportion of participants||95% Confidence Interval|Number
65938|NCT01151137|Secondary|Deaths|Deaths were classified according to the primary cause of death.|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||participants|||Number
65939|NCT01151137|Primary|Time to Second Co-primary Outcome (Cumulative Incidence Function)|"Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood’s variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||proportion of participants||95% Confidence Interval|Number
65940|NCT01151137|Primary|Time to First Co-primary Outcome (Cumulative Incidence Function)|"Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood’s variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined||proportion of participants||95% Confidence Interval|Number
65941|NCT01151137|Primary|Overview of the Two Co-primary Outcomes|"First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death.~Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause.~Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population: All randomized participants considered in the treatment group to which they were randomized regardless of the treatment they actually received||participants|||Number
65942|NCT01151098|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.|28 weeks|The Extension Safety population (N = 189) includes all subjects who were exposed to BTDS during the Open-label Extension Phase and provided at least 1 valid safety assessment after exposure to BTDS during the Open-label Extension Phase.||participants|||Number
65943|NCT01151085|Secondary|Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.|Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
65944|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
65945|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks|||participants|||Number
65946|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
65947|NCT01151085|Secondary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|16 weeks|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.||events|||Number
65948|NCT01151085|Primary|Number of Participants That Responded to Voriconazole Treatment.|The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
65949|NCT01151085|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|No statistical analysis provided for the frequency of treatment related adverse events.||participants|||Number
65950|NCT01151046|Secondary|Overall Survival|To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, over approximately 2 years|||weeks||95% Confidence Interval|Median
65951|NCT01151046|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Exemestane in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RT-PCR for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to exemestane can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 79.1 weeks|Patients with available tissue for RT-PCR analysis||months PFS||95% Confidence Interval|Median
65952|NCT01151046|Primary|Progression Free Survival (PFS)|"To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 79.1 weeks|||weeks||95% Confidence Interval|Median
65953|NCT01151020|Primary|Patients With Device Failures|Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.|12 months|||participants|||Number
65954|NCT01151020|Primary|Patients With Major Adverse Events (MAE)|"Major adverse event is defined as:~All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room."|30 days|1 patient had a stroke and required ventilation >72 hours/reintubation.||participants|||Number
65955|NCT01150981|Secondary|Serum Adiponectin|Adiponectin concentrations in serum were measured in ng/ml, in both arms at baseline and at 8 weeks, i.e. 2 weeks after stopping drug or placebo treatment|8 weeks|||ng/ml||Standard Error|Mean
65956|NCT01150981|Primary|Adipose Tissue Capillary Sprout Formation|Adipose tissue collected at 8 weeks was cut into ~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.|8 weeks|The number of subjects was based on the power of calculations in being able to demonstrate a difference from baseline in fat tissue microvasculature, change in HOMA2 and serum adiponectin after 6 weeks of rosiglitazone intake in all groups.||number of capillary sprouts||Standard Deviation|Mean
65957|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period|New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
65958|NCT01150903|Secondary|Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
65959|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period|New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
65994|NCT01150474|Primary|Pain at Hour 4|"Pain at 4 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|4 hours following surgery|||units on a scale||Standard Deviation|Mean
65960|NCT01150903|Primary|Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants|||Number
65961|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 366 up to Day 457 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.||Percentage of participants|||Number
65962|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.||Percentage of participants|||Number
65963|NCT01150903|Primary|Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91|New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 0 to Day 91 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.||Percentage of participants|||Number
65964|NCT01150903|Primary|Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription|Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.||Percentage of participants|||Number
65965|NCT01150760|Primary|Intensive Care Unit Length of Stay||Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Days||Standard Deviation|Mean
65966|NCT01150760|Primary|Percentage of Patients Discharged to Various Locations|Location of discharge for patients who were admitted to the hospital for their bowel resection from home|Hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of participants|||Number
65967|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 30 Days of Discharge||Between 0-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of participants|||Number
65968|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge||Between 16-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of participants|||Number
65969|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 15 Days of Discharge||Within 15 days of discharge from hospitalization for bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)||Percent of partcipants|||Number
65970|NCT01150760|Primary|Percentage of Patients With In-hospital Other Morbidity|Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65971|NCT01150760|Primary|Percentage of Patients With In-hospital Thromboembolic Morbidity|Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolism and infarction; arterial embolism and thrombosis or thrombosis of the lower extremities; vascular disorders of the kidney; acute vascular insufficiency of the intestine; or venous thromboembolism.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65972|NCT01150760|Primary|Percentage of Patients With In-hospital Infection Morbidity|Infection morbidity was identified using ICD-9-CM diagnosis and procedure codes for infection due to central venous catheter; abscess of intestine; peritoneal abscess; sepsis or severe sepsis; infection due to vascular device, implant and graft; urinary tract infection; disruption of internal or external surgical wound; persistent postoperative fistula; or postoperative infection.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65973|NCT01150760|Secondary|Postoperative Length of Hospital Stay|Calendar day of discharge - calendar day of surgery = postoperative length of stay|Measured from the day after bowel resection to the day of hospital discharge|Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan [for alvimopan cohort] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day)||Days||Standard Deviation|Mean
65974|NCT01150760|Primary|Percentage of Patients With In-hospital Pulmonary Morbidity|Pulmonary morbidity was identified using ICD-9-CM diagnosis and procedure codes for pneumonia; infectious pneumonia; respiratory complications, pulmonary collapse; acute respiratory failure or edema; pulmonary congestion and hypostasis; pulmonary/respiratory insufficiency after trauma and/or surgery; dyspnea; or respiratory arrest; transfusion related acute lung injury.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65975|NCT01150760|Primary|Percentage of Patients With In-hospital Cerebrovascular Morbidity|Cerebrovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for ischemic, thrombotic, embolic or hemorrhagic cerebrovascular accidents; acute but ill-defined cerebrovascular disease; transient cerebral ischemia; syncope; or postoperative cerebrovascular accident.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65976|NCT01150760|Primary|Percentage of Patients With In-hospital Cardiovascular Morbidity|Cardiovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for myocardial infarction; other ischemic events; congestive heart failure and shock; arrhythmias; or other cardiovascular events (cardiac complications, peripheral vascular complications).|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65977|NCT01150760|Primary|Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity|GI morbidity will be identified using International Classification of Disease 9th Edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes for paralytic ileus, flatulence, eructation, gas pain, insertion of a nasogastric tube, total parenteral nutrition, peripheral parenteral nutrition, digestive symptom complications, diarrhea following GI surgery, intestinal obstruction, abdominal pain, peritoneal adhesions, unspecified protein-calorie malnutrition, parenteral infusion of concentrated nutritional substances, or enteral infusion of concentrated nutritional substances.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65978|NCT01150760|Primary|Percentage of Patients Who Died|All-cause|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)||Percent of participants|||Number
65979|NCT01150500|Secondary|Clinical Endpoints|Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis|5 Years||08/2016||||
65980|NCT01150500|Secondary|Percent Diameter Stenosis|The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).|Baseline and 9 month|67 lesions in 65 patients were analyzed.||% DS (diameter stenosis)||Standard Deviation|Mean
65981|NCT01150500|Secondary|Minimum Luminal Diameter|The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.|9 month|67 lesions in 65 patient were analyzed.||mm||Standard Deviation|Mean
65982|NCT01150500|Secondary|Binary Angiographic Restenosis|Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.|Baseline and 9 month|67 lesions in 65 patients were analysed.||percentage of patient|||Number
65983|NCT01150500|Secondary|Late Lumen Loss|Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.|Baseline and 9 months|67 Lesions in 65 patients are analysed.||mm||Standard Deviation|Mean
65984|NCT01150500|Secondary|MACE (Major Adverse Cardiac Event)|Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.|Baseline and 9 month|65 patients were analyzed as ITT population||percentage of patient|||Number
65985|NCT01150500|Primary|Target Lesion Failure(TLF)|Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)|9 month|All 65 patients enrolled were analyzed as intent-to-treat (ITT) population and per protocol(PP) population.||percentage of TLF|||Number
65995|NCT01150461|Secondary|Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year|||Percentage change in LV mass||Inter-Quartile Range|Mean
65998|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non-­Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non­dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."||mmHg||Standard Deviation|Mean
65999|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm – 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am –6pm) ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."||mmHg||Standard Deviation|Mean
66000|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.|Baseline to Week 4|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mmHg||Standard Error|Least Squares Mean
66001|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)|Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24­hour monitoring period for removal of device and BP assessments. The ABPM device was pre­set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 – 24 hours.|Baseline to endpoint (Week 4 or LOCF)|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here 'Number of participants analyzed' signifies those participants evaluable for this measure at specified time points for each arm, respectively.||mmHg||Standard Deviation|Mean
66002|NCT01150357|Secondary|Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)|Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."||Percentage of participants|||Number
66003|NCT01150357|Secondary|Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3*(SBP-DBP).|Week 4 to endpoint (Week 8 or LOCF)|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mmHg||Standard Error|Mean
66004|NCT01150357|Secondary|Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP­DBP).|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for MAP at Week 4 (or LOCF) for each arm, respectively."||mmHg||Standard Error|Mean
66005|NCT01150357|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 8 or LOCF for each arm, respectively."||mmHg||Standard Error|Mean
66006|NCT01150357|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 4 or LOCF for each arm, respectively."||mmHg||Standard Error|Mean
66007|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|From Week 4 to Week 8|The analysis was performed on the SAF which included all participants who received at least one dose of study treatment during phase 2 (week 4 to week 8).||participants|||Number
66043|NCT01149733|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf|Blood samples drawn over 60 hour period|||ng*h/mL||Standard Deviation|Mean
66008|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Baseline up to Week 4|The analysis was performed on the Safety Sets (SAF), SAF is all participants who received at least one dose of study treatment during phase 1 (baseline to week 4)||participants|||Number
66009|NCT01150357|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|The primary analysis was performed on the FAS population.||mmHg||Standard Error|Mean
66010|NCT01150357|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))|"The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post­baseline assessment for primary efficacy. Here, Number of participants analyzed signifies participants evaluable for msSBP at Week 4 or LOCF for each arm, respectively."||millimeter(s) of mercury (mmHg)||Standard Error|Mean
66011|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini–Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.~Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|3 Months|Not all participants completed 3 month follow up neurocognitive testing.||Scores on a scale||Standard Deviation|Mean
66012|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini–Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.~Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|Baseline|||scores on a scale||Standard Deviation|Mean
66013|NCT01150097|Primary|Change in Renal Function|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.|from months 24 to 36|The analysis population included extension participants who had both post-extension baseline and month 36 values only.||mL/min/1.73m^2||Standard Deviation|Mean
66014|NCT01150097|Secondary|Incidence Rate of tBPAR|The number of participants who had a tBPAR was analyzed. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection.|from months 24 - 36|All extension participants||Participants|||Number
66015|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 - 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group||Participants|||Number
66016|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants||Participants|||Number
66017|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 to 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group||Participants|||Number
66044|NCT01149733|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t|Blood samples drawn over 60 hour period|||ng*h/mL||Standard Deviation|Mean
66018|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants||Participants|||Number
66019|NCT01149876|Secondary|Change in Rhytides|"Secondary outcome measures will be change in rhytides of baseline compared to week 16.~Rhytides will be assessed clinically using a 0-6 scale where 0 is no lines and 6 is very deep lines."|baseline to week 16|||units on a scale||Standard Deviation|Mean
66020|NCT01149876|Primary|Change in Hyperpigmentation of the Face|"Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16.~Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation."|baseline to 16 weeks|||units on a scale||Standard Deviation|Mean
66021|NCT01149863|Secondary|Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs||Within the first 5 days following plerixafor initiation|||Participants|||Number
66022|NCT01149863|Primary|Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.||Within the first 5 days following plerixafor initiation|||Participants|||Number
66023|NCT01149785|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (Cmax).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
66024|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC(0-∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) [MRAUC(0-∞)].|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
66025|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
66026|NCT01149785|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
66027|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
66028|NCT01149785|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66029|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66045|NCT01149733|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax|Blood samples drawn over 60 hour period|||ng/mL||Standard Deviation|Mean
66070|NCT01149486|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
66030|NCT01149785|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
66031|NCT01149785|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
66032|NCT01149785|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
66033|NCT01149785|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
66034|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
66035|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66036|NCT01149785|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66037|NCT01149772|Primary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ measures the health status of patients with congestive heart failure. The overall score is a mean score scaled from 0 - 100; where 0 represents most severe/limited functioning.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|Only patients randomized for heart failure was required to complete the assessment. There were fewer patients randomized for congestive heart failure (CHF) as compared to COPD.||units on a scale||Standard Deviation|Mean
66038|NCT01149772|Primary|Chronic Respiratory Questionnaire_Dyspnea|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Dyspnea looks at how much shortness of breath a patient experiences. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment.||units on a scale||Standard Deviation|Mean
66039|NCT01149772|Primary|Chronic Respiratory Questionnaire_Mastery|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patient's perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.||units on a scale||Standard Deviation|Mean
66040|NCT01149772|Primary|Chronic Respiratory Questionnaire_Fatigue|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. This subscale measures the amount of fatigue patients experience with the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.||units on a scale||Standard Deviation|Mean
66041|NCT01149772|Primary|Beck Anxiety Inventory (BAI)|The BAI measures an individual's level of anxiety. The measure is summed and ranges from 0 - 63 (individual item score range 0 -3 per 21 items); were higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|||units on a scale||Standard Deviation|Mean
66042|NCT01149772|Primary|Patient Health Questionnaire -9 (PHQ-9)|The PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|||units on a scale||Standard Deviation|Mean
66046|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).|The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 95 and 45.||Units on a scale||Standard Deviation|Mean
66047|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Negative Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.||Units on a scale||Standard Deviation|Mean
66048|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Positive Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.||Units on a scale||Standard Deviation|Mean
66049|NCT01149655|Other Pre-specified|Mean CGI-I Score at Endpoint.|Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. Response choices included: 0 = not assessed; 1 = very much improved,;2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.||Units on a scale||Standard Deviation|Mean
66050|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in CGI-S Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0= not assessed; 1= normal, not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.||Units on a scale||Standard Deviation|Mean
66051|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Total Score.|The PANSS consisted of 3 subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF (last observation carried forward) method was used to impute missing data. Week 1 had only 95 and 45 participants analyzed.||Units on a scale||Standard Deviation|Mean
66052|NCT01149655|Secondary|Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.|Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants who were randomized to period 3.||percentage of participants|||Number
66053|NCT01149655|Secondary|Percentage of Participants Who Had Achieved Remission.|Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants who were randomized to the double-blind treatment. For evaluation of remission, 48 of 98 aripiprazole participants and 19 of 48 placebo participants met the 6 month threshold for remission analysis. Of those, 21 of 48 aripiprazole participants and 8 of 19 placebo participants met criteria for remission.||percentage of participants|||Number
66054|NCT01149655|Secondary|Percentage of Responders in Each Treatment Group.|Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants were randomized to period 3.||percentage of participants|||Number
66068|NCT01149486|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66069|NCT01149486|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66055|NCT01149655|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of all participants who were randomized to period 3.||percentage of participants|||Number
66056|NCT01149655|Primary|Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.|The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.|Baseline to Week 52/End of Phase 3 visit.|For the primary analysis, participants that belonged to the ITT (intent to treat) data set were included in the analysis. Participants who were lost to follow-up or who were still in the study at the end of Week 52 were considered as censored on their date of last efficacy evaluation. The ITT data set comprised participants randomized to period 3.||relapse rate(percentage of participants)|||Number
66057|NCT01149538|Secondary|Evoked Response Potential - Negative Component Latency|Evoked Response Potential - negative component latency data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms)||Milliseconds||Standard Deviation|Mean
66058|NCT01149538|Secondary|Evoked Response Potentials Microvolts|Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms)||Mircovolts||Standard Deviation|Mean
66059|NCT01149538|Secondary|Elicited Imitation Task Memory|The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.|Baseline, 6 months, and 9 months|Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16).||Slope||Standard Error|Mean
66060|NCT01149538|Primary|Mullen Scales of Early Learning - Early Learning Composite|The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.|Baseline and 9 months|Including those with partial completion (drop-outs and lost-to-followup).||units on a scale||Standard Deviation|Mean
66061|NCT01149538|Primary|Side Effects of Choline Bitartrate|Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.|Baseline, 6 months, & 9 months|Children with fetal alcohol spectrum disorders receiving either choline or placebo for 9 months||participants|||Number
66062|NCT01149486|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66063|NCT01149486|Secondary|AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66064|NCT01149486|Secondary|Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
66065|NCT01149486|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66066|NCT01149486|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66067|NCT01149486|Primary|Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
66071|NCT01149473|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66072|NCT01149473|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66073|NCT01149473|Primary|Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
66074|NCT01149473|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66075|NCT01149473|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
66076|NCT01149473|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
66077|NCT01149460|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
66078|NCT01149460|Secondary|AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
66079|NCT01149460|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
66080|NCT01149460|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
66081|NCT01149460|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
66082|NCT01149460|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
66083|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years|||Participants|||Number
66084|NCT01149434|Primary|Tumor Response in the Ovarian Cancer Cohort|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors|2 years|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. The number of patients enrolled on the remaining cohorts were not included in this analysis.||Participants|||Number
66085|NCT01149434|Primary|Progression Free-Survival in the Ovarian Cancer Cohort|progression-free survival at 2 months. We define progression as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), to detect a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 months|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. Patients enrolled on the remaining cohorts were excluded in this analysis. Results were calculated using Kaplan-Meier product limit methods.||percentage of participants||95% Confidence Interval|Number
66086|NCT01149434|Secondary|Tumor Response|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years|||participants|||Number
66087|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years|||participants|||Number
66088|NCT01149434|Primary|Effect of RAD001 on Pharmacokinetics AUC(0-inf) of JI-101|Determine the mean percent change that RAD001 has on the peak concentration as determined by calculating the AUC (0-inf) of JI101 in the presence and absence of RAD001|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 8 for RAD001 + JI101 and Cycle 1 Day 15 for JI-101 alone|||percentage change||Full Range|Mean
66089|NCT01149434|Primary|Effect of JI 101 on Pharmacokinetics Area Under Curve (AUC) (0-inf) of RAD001|Determine the mean percent change that JI-101 has on the peak concentration as determined by calculating the AUC (0-inf) of RAD001 in the presence and absence of JI-101|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 1 for RAD001 alone and Cycle 1 Day 8 for RAD001 + JI-101|||percentage change||Full Range|Mean
66102|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)|Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
66090|NCT01149421|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4, 8, 12, 16, and 26 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.||nanograms*hour per liter (ng*h/L)||Standard Deviation|Mean
66091|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Body Weight|Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data.||kilogram (kg)||Standard Error|Least Squares Mean
66092|NCT01149421|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||events per participant per 30 days||Standard Deviation|Mean
66093|NCT01149421|Secondary|Anti-LY2189265 Antibodies|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized.|Baseline, 16, 26, and 30 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable anti-drug (LY2189265) antibodies (ADA) data.||participants|||Number
66094|NCT01149421|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||participants|||Number
66095|NCT01149421|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||events|||Number
66096|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Fridericia-corrected QT (QTcF) or PR interval change from baseline data.||milliseconds (msec)||Standard Error|Least Squares Mean
66097|NCT01149421|Secondary|Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)||Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable High-Sensitivity C-Reactive Protein (hs-CRP) data.||milligram per liter (mg/L)||Standard Deviation|Mean
66098|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Serum Calcitonin||Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable serum calcitonin data.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
66099|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pancreatic enzyme data.||units per liter||Inter-Quartile Range|Median
66100|NCT01149421|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.||participants|||Number
66101|NCT01149421|Secondary|Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with Chi-squared test/Fisher’s exact test.|Baseline and 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.||percentage of participants|||Number
66137|NCT01148836|Secondary|Red Blood Cell Distribution Width||before and after three months of CoQ|||percentage of sizes of red blood cells||Standard Deviation|Mean
66103|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)|Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.||percentage of HbA1c||Standard Error|Least Squares Mean
66104|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)|Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66105|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure|Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66106|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)|Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
66107|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)|Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66108|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)|Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66109|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)|Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66138|NCT01148836|Secondary|Mean Corpuscular Hemoglobin||before and after three months of CoQ|||pg||Standard Deviation|Mean
66139|NCT01148836|Secondary|Hematocrit||before and after three months of CoQ|||% of red blood cell||Standard Deviation|Mean
66140|NCT01148836|Secondary|Hemoglobin||before and after three months of CoQ|||g/dl||Standard Deviation|Mean
66110|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure|Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66111|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)|Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
66112|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)|Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.||millimeters of mercury (mmHg)]||Standard Error|Least Squares Mean
66113|NCT01149421|Secondary|Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66114|NCT01149421|Primary|Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
66115|NCT01149057|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||units on a scale||Standard Deviation|Mean
66116|NCT01149057|Secondary|Participant Assessment of Pain (VAS)|"The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated No pain, and the right endpoint (100) indicated Unbearable pain. Higher score indicated higher pain."|Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||mm||Standard Deviation|Mean
66117|NCT01149057|Secondary|Erythrocyte Sedimentation Rate||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||millimeter per hour||Standard Deviation|Mean
66118|NCT01149057|Secondary|C-reactive Protein Level||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||milligram per deciliter||Standard Deviation|Mean
66119|NCT01149057|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96||Baseline; Weeks 20, 44, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||gram per deciliter||Standard Deviation|Mean
66141|NCT01148836|Secondary|Red Blood Cells||before and after three months of CoQ|||10^6 cells/µl||Standard Deviation|Mean
66120|NCT01149057|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96|ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||percentage of partcipants|||Number
66121|NCT01149057|Secondary|Change From Baseline in SJC At Weeks 24, 48, 72, and 96|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.||swollen joints||Standard Deviation|Mean
66122|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
66123|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
66124|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
66125|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|Per Protocol (PP) population: all participants who completed the study. Number of participants analyzed=participants with available data for this outcome. Here 'n' signifies the participants with available data for specified time point.||units on a scale||Standard Deviation|Mean
66126|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|ITT population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
66127|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|ITT population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
66142|NCT01148836|Primary|Right Atrial Pressure||before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||mmHg||Standard Deviation|Mean
66143|NCT01148836|Primary|Tricuspid Regurgitation Grade|Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||units on a scale||Standard Deviation|Mean
66128|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|ITT population. Number of participants analyzed=participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
66129|NCT01149057|Secondary|Change From Baseline in TJC At Weeks 24, 48, 72, and 96|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.||tender joints||Standard Deviation|Mean
66130|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96|CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
66131|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96|SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter [cm]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
66132|NCT01149057|Secondary|Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96|The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline <-1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline <-0.6 to greater than or equal to (≥) -1.2.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
66133|NCT01149057|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score <2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.||percentage of participants|||Number
66134|NCT01149057|Secondary|Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score less than (<) 2.6. The DAS28 score was a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity (visual analog scale [VAS]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.||participants|||Number
66135|NCT01149057|Secondary|Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study|BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation [SD] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.|Baseline, End of the study (up to Week 100)|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number of participants with available data for specified category.||T-score||Standard Deviation|Mean
66136|NCT01149057|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|ITT population. Number of participants analysed=participants with available data for this endpoint. Here, 'n' signifies participants with available data at specified time point.||units on a scale||Standard Deviation|Mean
66144|NCT01148836|Primary|Right Ventricle Myocardial Performance|Tei Index=(IRT+ICT)/ET, where IRT is isovolumic|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||ratio||Standard Deviation|Mean
66145|NCT01148836|Primary|Right Ventricular Outflow|Velocity time interval|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||cm||Standard Deviation|Mean
66146|NCT01148836|Primary|Left Ventricular End Diastolic Volume|Amount of blood in ventricle at end of diastole|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q||ml||Standard Deviation|Mean
66147|NCT01148771|Primary|Area Under the Curve From 48 to 72 Hours [AUC(48-72)]|AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.|0-24 hours after 3rd ertapenem dose|||mcg*hr/mL||Standard Deviation|Mean
66148|NCT01148771|Secondary|Probability of Target Attainment (PTA)|After simulating 5000 patients receiving each dosing regimen, the probability of achieving free drug concentrations above an MIC of 0.25 mcg/mL and 0.5mcg/mL for at least 40% of the dosing interval (40% fT>MIC) is calculated at each MIC dilution.|Simulated Steady-State Exposure|The probability of achieving 40% T>MIC is reported at a MIC of 0.25mcg/mL and 0.5mcg/mL respectively.||% of 5000 simulated patients|Participants||Number
66149|NCT01148771|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The following laboratory assessments will be make before and after participation in the study to determine if objective changes occurred: blood pressure, pulse rate, temperature, complete blood count with differential, platelet count, blood urea nitrogen, serum creatinine, liver function panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase], total bilirubin, and urinalysis with microscopy. Monitoring of other pathologic or unintended changes in structure (signs),or function (symptoms) of the body associated with participation in the study will occur.|3 days|||participants|||Number
66150|NCT01148771|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)|Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.|5 or 30 minutes post start of infusion on Day 3|Each participant received ertapenem as a 5 minute infusion and as a 30 minute infusion, only in different order due to cross-over design. Data for all participants receiving each dosage regimen are included in each arm for results.||mcg/mL||Standard Deviation|Mean
66151|NCT01148745|Secondary|Serum Ferritin|Serum ferritin values were measured at all visits|7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)|||g/mL||Full Range|Median
66152|NCT01148745|Secondary|Transferrin Saturation (TSAT)|Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100|7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.|||percent||Full Range|Median
66153|NCT01148745|Primary|Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize|TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.|pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration|||weeks|||Number
66154|NCT01148693|Primary|Number of Participants With Cholangitis|After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis|72 hours|||participants|||Number
66155|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia’s Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia’s method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."||QTcF (msec)||Standard Deviation|Least Squares Mean
66156|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Fridericia’s Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia’s method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTcF (msec)||Standard Deviation|Least Squares Mean
66165|NCT01148524|Primary|Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set.Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.||Geometric mean titers||95% Confidence Interval|Geometric Mean
66157|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett’s method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."||QTcB (msec)||Standard Deviation|Least Squares Mean
66158|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett’s method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTcB (msec)||Standard Deviation|Least Squares Mean
66159|NCT01148537|Secondary|The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation~For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
66160|NCT01148537|Primary|The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
66161|NCT01148537|Secondary|The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
66162|NCT01148537|Primary|The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."||QTci (msec)||Standard Deviation|Least Squares Mean
66163|NCT01148524|Primary|Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|18 months after last vaccination V72P10 study.|Analysis was performed on the MITT dataset.||UI/mL||95% Confidence Interval|Geometric Mean
66164|NCT01148524|Primary|Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.|The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.|month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set. Naive group was not reported for this endpoint since GMR data for this group were not collected (subjects were enrolled in this study and no GMT values at 1m and 18 m after last vaccination in V72P10 are available).||Geometric mean ratio||95% Confidence Interval|Number
66166|NCT01148524|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the modified intention-to-treat (MITT) data set, i.e. all subjects who provided evaluable serum samples. Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.||Percentage of subjects||95% Confidence Interval|Number
66167|NCT01148511|Secondary|Quality of Life|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient’s subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.|Visits 2, 6, 9, 12, and 15 (up to 12 months)|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Units on a scale||Full Range|Median
66168|NCT01148511|Secondary|Change in Central Retinal Thickness From Baseline to Month 12|Retinal thickness was measured using Optical Coherence Tomography (OCT).|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||µm||Full Range|Median
66169|NCT01148511|Secondary|Follow-up Duration|Follow-up duration was defined as the number of days from Baseline to study discontinuation.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Days||Full Range|Mean
66170|NCT01148511|Secondary|Number of Visits||Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Visits||Full Range|Median
66171|NCT01148511|Secondary|Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Percentage of patients|||Number
66172|NCT01148511|Primary|Change in Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||Letters||Full Range|Median
66173|NCT01148511|Primary|Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.||logMAR||Full Range|Median
66174|NCT01148420|Primary|Cessation of Bleeding Within 5 Days|Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5|3-5 days|||participants|||Number
66175|NCT01148420|Secondary|Satisfaction and Willingness to Recommend Treatment|Participants were asked whether they would recommend this treatment to a friend|End of the trial; up to day 5|||participants|||Number
66176|NCT01148420|Secondary|Patient Perception of the Acceptability of the Treatment|Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent.|End of the trial; up to day 5|||units on a scale||Full Range|Median
66177|NCT01148056|Secondary|Accuracy|To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
66178|NCT01148056|Secondary|Quantity of Circulating Tumor Cells|To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
66179|NCT01148056|Secondary|Tissue Microarray|To determine changes in the tumor induced by radiation as assessed by tissue microarray.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
66180|NCT01148056|Secondary|Surgical Complication Rate|To determine the surgical complication rate in patients who received preoperative radiation therapy.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
66181|NCT01148056|Secondary|Pelvic Control Rate|To determine the pelvic control rate of patients after short course radiation therapy and surgery.|2 years|Study was closed early due to poor accrual. Analyses not completed.|||||
66182|NCT01148056|Primary|Bowel Quality of Life|To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.|2 years|Study was terminated early due to slow accrual. Analysis was not performed.|||||
66183|NCT01148017|Secondary|Percentages of Subjects Reporting Unsolicited AEs and SAEs|Percentages of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.|Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).|Analysis was done on the Post MenACWY at 60 months safety set ie, all subjects who received a vaccination at 60 months and were assessed for postvaccination safety, and on the Post MenACWY at 40 Months Safety Set, ie, the Naive subjects enrolled at 40 months of age who received vaccination at 40 months and were assessed for postvaccination safety.||Percentages of subjects|||Number
66184|NCT01148017|Secondary|Percentages of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity|"Percentages of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.~Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs."|From day 1 to 7 after vaccination.|Analysis was done on the Solicited Safety Set (from 6 hours to day 7), ie, all subjects who received a vaccination at 60 months and provided postvaccination solicited safety data.||Percentages of subjects|||Number
66185|NCT01148017|Secondary|Percentage of Subjects With Seroresponse at 1 Month Post-vaccination|"The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.~Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4."|Visit 11, 1 month after vaccination.|Analysis was done on the PPS Post-MenACWY-CRM.||Percentage of subjects||95% Confidence Interval|Number
66186|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination|The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.|Visit 11, 1 month after vaccination.|Analysis was done on the PPS-Immunogenicity after one dose of MenACWY-CRM (PPS Post-MenACWY-CRM), ie, all subjects in the enrolled population who correctly received the vaccine, provided at least one evaluable serum sample at the relevant time points and whose assay result was available for at least one serogroup with no major protocol deviation.||Percentages of subjects||95% Confidence Interval|Number
66187|NCT01148017|Secondary|hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age|The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.||Titers||95% Confidence Interval|Geometric Mean
66188|NCT01148017|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-months of age.|Analysis was done on the PPS 40-month persistence.||Titers||95% Confidence Interval|Geometric Mean
66189|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.||Percentages of subjects||95% Confidence Interval|Number
66190|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9, 40 months of age.|Analysis was done on the PPS 40-month persistence.||Percentages of subjects||95% Confidence Interval|Number
66191|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age|Analysis was done on the Per Protocol Set 60-Month persistence (PPS 60-Month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 60-month of age visit and had no major protocol deviation.||Percentages of subjects||95% Confidence Interval|Number
66192|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-month visit.|Analysis was done on the Per Protocol Set 40-month persistence (PPS 40-month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviation.||Percentages of subjects||95% Confidence Interval|Number
66193|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment|"The subject was asked to rate his global evaluation of the efficacy of treatment using the following 5-point scale:~0=not at all effective~a little bit effective~moderately effective~quite a bit effective~extremely effective."|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
66194|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment|Subject was asked to rate the severity of his constipation using a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
66195|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
66196|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of subjects|||Number
66197|NCT01147926|Secondary|Days With Rescue Medication Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||Days/week||Standard Deviation|Mean
66198|NCT01147926|Secondary|Bisacodyl Tablets Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||Tablets/week||Standard Deviation|Mean
66199|NCT01147926|Secondary|Time to First SCBM After Investigational Product Intake on Day 1||Day 1|mITT.||hours||95% Confidence Interval|Median
66200|NCT01147926|Secondary|Percent SBM With Sensation of Complete Evacuation||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
66201|NCT01147926|Secondary|Percent SCBM With No Straining and Severe/Very Severe Straining|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
66202|NCT01147926|Secondary|Percent SBM With a Consistency of Normal and Hard/Very Hard|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||percentage of SBM||Standard Deviation|Mean
66203|NCT01147926|Secondary|SCBM Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.||SCBM/week||Standard Deviation|Mean
66204|NCT01147926|Secondary|Percentage of Subjects With an Increase of at Least 1 SCBM Per Week||Over 12 week treatment period|mITT||percentage of subjects|||Number
66205|NCT01147926|Secondary|Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period||Over 12 week treatment period|mITT||percentage of subjects|||Number
66206|NCT01147926|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 12 week treatment period|Modified Intent-to-treat Population (mITT) included all subjects randomized into the study except those excluded due to a major good clinical practice (GCP) breach at one site, who took at least 1 dose of the investigational product.||percentage of subjects|||Number
66207|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 8.5 up to study end (one month post Year 10 booster vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
66208|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..|At Year 8.5|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
66209|NCT01147900|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
66210|NCT01147900|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
66211|NCT01147900|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.||subjects|||Number
66212|NCT01147900|Primary|Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.|"A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination.~A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL."|At 1 month post Year 10 booster vaccination|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
66213|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
66214|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
66215|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
66216|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
66217|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||EL.U/mL||95% Confidence Interval|Geometric Mean
66218|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||subjects|||Number
66219|NCT01147900|Primary|Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||EL.U/mL||95% Confidence Interval|Geometric Mean
66300|NCT01147471|Primary|Morbidity|total days on ventilator, ICU length of stay, hospital length of stay|Measured daily during hospitalization (approx 1 month)|analysis is the mean and standard deviation for # days spent on each item measured||days||Standard Deviation|Mean
88105|NCT00928083|Secondary|OZ439 t1/2|Apparent terminal half-life (t1/2)|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||hours||Geometric Coefficient of Variation|Geometric Mean
66220|NCT01147900|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||subjects|||Number
66221|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||IU/mL||95% Confidence Interval|Geometric Mean
66222|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus.|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.||subjects|||Number
66223|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||IU/mL||95% Confidence Interval|Geometric Mean
66224|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.||subjects|||Number
66225|NCT01147874|Secondary|Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Primary PsA diagnosis made by rheumatologist based on physical examination, medical history and laboratory test results. Secondary PsA diagnosis made by rheumatologist based on physical examination and medical history only. For both, numerator was number of participants with “No” answer to question concerning previous diagnosis of PsA at Visit 1 (dermatology visit) and were subsequently classified as positive by rheumatologist; denominator was total number of participants evaluated for PsA.|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.||Percentage of participants||95% Confidence Interval|Number
66226|NCT01147874|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history and physical examination as the basis for the diagnosis.|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.||Percentage of participants||95% Confidence Interval|Number
66227|NCT01147874|Primary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history, physical examination and laboratory results as the basis for the diagnosis.|Week 0 through Week 8|Full analysis set (FAS) population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.||Percentage of participants||95% Confidence Interval|Number
66228|NCT01147848|Other Pre-specified|Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at Day 168|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). The second part is a 20 centimeter VAS that has endpoints labelled best imaginable health state and worst imaginable health state anchored at 100 and 0, respectively. Participants were asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS that best represents their own health on that day. Analysis was performed using ANCOVA with covariates of Baseline VAS score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||scores on a scale||Standard Error|Least Squares Mean
66316|NCT01147380|Secondary|NK Cell Infusion-related Toxicity|To assess NK cell infusion -related toxicity at the bedside. We will monitor the patient and check the vital sign. If any side effect are noticed, we will record and report to the data safety monitoring comittee.|1 year|Participants were devided two group( small and large dose) as described based on the dose of infused cell numbers.||participants|||Number
66229|NCT01147848|Other Pre-specified|"Percentage of Participants With No Problems in the EQ-5D Descriptive System Dimensions at Day 168/Week 24"|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by a three-point Likert scale (1=no problems, 2=some problems and 3=severe problems). Respondents are asked to choose one level that reflects their own health state today for each of the five dimensions."|Day 168/Week 24|ITT Population. Only those participants available at the indicated time point were assessed.||percentage of participants|||Number
66230|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score for Participants 12 Years of Age and Older (AQLQ + 12)|"The AQLQ is a disease-specific, self-administered quality of life (QOL) questionnaire developed to evaluate the impact of asthma treatments on the QOL of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The response format consists of a 7-point scale: a value of 1 indicates total impairment; a value of 7 indicates no impairment. The AQLQ total score is defined as the average of the scores from all 32 questions, provided at least 90% of the questions have been answered; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Change from Baseline was calculated as the Day 168 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline total AQLQ score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Scores on a scale||Standard Error|Least Squares Mean
66231|NCT01147848|Other Pre-specified|Number of Healthcare Contacts Related to Asthma or the Treatment of Asthma From Baseline to Day 168|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (to the general ward [GW] or the intensive care unit [ICU]) that were associated with asthma exacerbations were recorded.|Baseline to Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||visits per participant||Standard Deviation|Mean
66232|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Control Test (ACT) Scores at Day 168|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the Day 168 value minus the Baseline value."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed. Analysis was performed using ANCOVA with covariates of Baseline total ACT score, country, sex, age, and treatment.||Scores on a scale||Standard Error|Least Squares Mean
66233|NCT01147848|Other Pre-specified|Baseline FEV1 by Completion Status|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.|Baseline|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Deviation|Mean
66234|NCT01147848|Secondary|Change From Baseline in Trough FEV1 at Day 168|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Trough FEV1 is defined as the pre-dose measurement on Day 168/Week 24. Any missing data at Day 168/Week 24 was imputed using the last observation carried forward (LOCF). Baseline was the pre-dose measurement on Day 1. Change from Baseline was calculated as the pre-dose measurement on Day 168/Week 24 minus the Baseline value.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
66235|NCT01147848|Secondary|Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1|The number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated at 12-hours post-dose and at 24-hours post-dose on Day 168.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
66236|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline and Day 168 was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Deviation|Mean
66237|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 1 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Randomization|ITT Population. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
66301|NCT01147458|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 is a terminal metabolic product of arachidonic acid by 5-LO. Its synthesis is dependent upon the activity of 5-LO and it is eliminated through urinary clearance. Hence, the level of urinary LTE4 (uLTE4) excretion may be an indicator of endogenous 5-LO activity.|Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)|Since the study was terminated prematurely for a potential safety signal, and in light of the efficacy analysis, the pharmacodynamic (PD) assessment of uLTE4 was not performed and no data are reportable.|||||
66238|NCT01147848|Secondary|Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1|Time to onset of bronchodilator effect at Day 1 is defined as the actual time during the 4-hour serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) measurements that the participant first meets or exceeds a 12% and 200 mL increase over Baseline and was derived at Day 1 only. Time to onset was calculated over 0 to 4 hours (5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours) post-dose. Participants who never exceeded a 12% and 200 mL increase over Baseline were censored at the actual time of their last FEV1 measurement.|Baseline to Day 1|ITT Population. Only those participants available at the indicated time points were assessed.||participants|||Number
66239|NCT01147848|Secondary|Serial FEV1 (0-24 Hours)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . The pre-dose FEV1 assessment and the individual serial FEV1 assessments at Day 168/Week 24 at the indicated time points (pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 11 hours, 12 hours, 12.5 hours, 13 hours, 14 hours, 16 hours, 20 hours, 23 hours, and 24 hour s) were summarized.|Day 168|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Deviation|Mean
66240|NCT01147848|Primary|Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168/Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only those participants available at the indicated time point were assessed.||Liters||Standard Error|Least Squares Mean
66241|NCT01147822|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of response until the earliest date of disease progression/death (up to 38 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.||Months||95% Confidence Interval|Median
66242|NCT01147822|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.||Weeks||95% Confidence Interval|Median
66243|NCT01147822|Secondary|Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC|The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian)||Participants|||Number
66244|NCT01147822|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization until death (up to 44 months)|ITT Population (Asian)||Months||95% Confidence Interval|Median
66245|NCT01147822|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization to the earliest date of disease progression or death (up to 39 months)|Intent-to-Treat (ITT) Population (Asian): All randomized participants (par) from Study VEG113078 and Study VEG108844 who enrolled in Japan, China, Taiwan, and Korea.||Months||95% Confidence Interval|Median
66246|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to >=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population||Days||Standard Deviation|Mean
66554|NCT01144052|Primary|Number of Days Until First On-study Relapse|Patients were followed-up during 12 months and time to first on-study relapse from randomization was recorded.|12 months|All enrolled and randomized patients fulfilled the criteria for analysis.||days||Full Range|Median
66247|NCT01147809|Secondary|Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population||Days||Standard Deviation|Mean
66248|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 1 to Cycle 6|ITT Population: Participants with at least one period of thrombocytopenia where duration could be calculated.||Days||Standard Deviation|Mean
66249|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II|As per the CTCAE version 4.0, participants with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets <150Gi/L) at least once within cycle are presented in the category title as n=X,X.|Cycle 1 to Cycle 6|ITT Population||Participants|||Number
66250|NCT01147809|Secondary|Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 1 Day 1 to last assessment in Cycle 6|ITT Population:Participants with platelet count data in at least one cycle in the study.||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
66251|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
66252|NCT01147809|Secondary|Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II|Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)|ITT Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
66253|NCT01147809|Secondary|Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.|Day 15 (averaged across cycles 1 to 6)|ITT Population||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
66254|NCT01147809|Secondary|Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.|Day 8 (averaged across cycles 1 to 6)|ITT Population||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
66302|NCT01147458|Secondary|Plasma Concentration of PF-04191834||Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43|Due to early termination of the study, only a subset of pharmacokinetic (PK) samples, from 10 out of 190 randomized participants, were selected for analysis. These 10 participants were selected based on treatment and treatment sequence.||ng/mL||Standard Deviation|Mean
66555|NCT01144026|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|5 weeks|all participants enrolled were analyzed||ng/mL||Full Range|Median
66255|NCT01147809|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|C1D4|Safety Population||participants|||Number
66256|NCT01147809|Secondary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II|ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1 and C17D1|Safety Population||participants|||Number
66257|NCT01147809|Secondary|Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II|Number of participants with at least 1 assessment of change from Baseline in creatinine, with increase >=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population||participants|||Number
66258|NCT01147809|Secondary|Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase II|"Clinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as Any grade increase, Increase to Grade 3 or Grade 4. Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles)."|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population||participants|||Number
66259|NCT01147809|Secondary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).|After baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
66260|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.|Cycle 1 to Cycle 6|ITT Population||Dose Intensity (%)||Standard Deviation|Mean
66261|NCT01147809|Secondary|Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.|Cycle 1 to Cycle 6|ITT Population||Participants|||Number
66262|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).|Cycle 1 to Cycle 6|ITT Population||Participants|||Number
66263|NCT01147809|Secondary|Number of Participants Requiring a Platelet Transfusion in Phase II|Platelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.|Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation|ITT Population||Participants|||Number
66314|NCT01147380|Secondary|Anti-HCV Effect of This Treatment (If Applicable)||2 year||||||
66264|NCT01147809|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase II|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.|Screening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-up|ITT Population: Participants with at least one visit within the cycle.||Participants|||Number
66265|NCT01147809|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase II|AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)|Safety Population||Participants|||Number
66266|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I|Any delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.|All time on chemotherapy treatment|Safety Population||Participants|||Number
66267|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within Cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).|Cycle 1 to Cycle 6|Safety Population||Dose Intensity (%)||Standard Deviation|Mean
66268|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population||Days||Standard Deviation|Mean
66269|NCT01147809|Secondary|Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population||Days||Standard Deviation|Mean
66270|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 2 to Cycle 6|Safety Population. Participants experiencing thrombocytopenia with subsequent increase in platelet count to >=150Gi/L are included.||Days||Standard Deviation|Mean
66271|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet Count|As per the CTCAE version 4.0, par. with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets <150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.|Cycle 1 to Cycle 6|Safety Population||Participants|||Number
66315|NCT01147380|Secondary|Anti-HCC Effect of This Treatment||2 year||||||
66272|NCT01147809|Secondary|Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 2 Day 1 to last assessment in Cycle 6|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
66273|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
66274|NCT01147809|Secondary|Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I|Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
66275|NCT01147809|Secondary|Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I|Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1,C4D8, C4D15, C5D1,C5D8, C5D15, C6D1,C6D8 and C6D15|Safety Population||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
66276|NCT01147809|Primary|Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).|Day 1 (averaged across cycles 1 to 6)|Intent-to Treat (ITT) Population: all randomized participants.||Giga (10^9) cells per liter (Gi/L)||Geometric Coefficient of Variation|Geometric Mean
66277|NCT01147809|Primary|Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|C2D4, C2D8, C5D8, C6D15|Safety Population||Participants|||Number
66278|NCT01147809|Primary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I|ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.|Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15|Safety Population||Participants|||Number
66279|NCT01147809|Primary|Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I|The number of participants with at least 1 change from Baseline in creatinine, with an increase >=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
66934|NCT01138150|Primary|Change in the Total Serum Adiponectin (T-ADP)|Change in total serum adiponectin after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
66280|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I|Clinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
66281|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population||Participants|||Number
66282|NCT01147809|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I|AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)|Safety Population||Participants|||Number
66283|NCT01147640|Secondary|Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population|Microbiological response is eradication (absence of the baseline pathogen from a suitable intra-abdominal specimen) or presumed eradication (absence of a suitable intra-abdominal specimen to culture at the TOC visit in a subject who is assessed as a clinical cure at TOC)|Test-of-Cure Visit (7-14 days after EOT)|Microbiologically Evaluable: treated subjects, with baseline pathogen susceptible to study drug, complied with protocol||percentage of subjects||95% Confidence Interval|Number
66284|NCT01147640|Primary|Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population|Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|Test-of-Cure Visit (7-14 days after End of Therapy [EOT])|mMITT: Treated subjects, with baseline pathogen||percentage of subjects||95% Confidence Interval|Number
66285|NCT01147627|Secondary|Safety and Tolerability in Different Groups||48 weeks||||||
66286|NCT01147627|Secondary|β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)||48 weeks||||||
66287|NCT01147627|Secondary|Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles||48 weeks||||||
66288|NCT01147627|Primary|the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks||48 weeks|||percentage of HbA1c||Standard Deviation|Mean
66289|NCT01147497|Secondary|Need for Additional Pain Medications After Insertion of the IUD||assessed one week after insertion||||||
66290|NCT01147497|Secondary|Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women||assessed immediately following insertion||||||
66291|NCT01147497|Secondary|Acceptability of Discomfort Associated With Insertion||assessed at one week after insertion and at one month after insertion||||||
66292|NCT01147497|Secondary|Time for Insertion Procedure||assessed immediately after IUD insertion||||||
66293|NCT01147497|Secondary|The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD||assessed immediately after IUD insertion|||participants|||Number
66294|NCT01147497|Secondary|Patient Perceived Pain on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).|immediately after insertion|||units on a scale||Full Range|Median
66295|NCT01147497|Primary|Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).|assessed immediately post IUD insertion|||units on a scale||Full Range|Median
66296|NCT01147471|Other Pre-specified|Still on Narcotics at Post-discharge Follow-up|Number of people still on narcotics at time of routine care post-discharge follow-up|approx 2 weeks post discharge|||participants|||Number
66297|NCT01147471|Secondary|Pulmonary Function|Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits|||||
66298|NCT01147471|Secondary|Quality of Life|Rand 36 health survey.|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits|||||
66299|NCT01147471|Primary|Mortality|Number of participants who died during any hospital stay.|Measured any time during hospital stay (approx 30 days)|||participants|||Number
66303|NCT01147458|Secondary|Rescue Medication Use|Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week.|Day -7 (Visit 2) up to 28-day follow-up (Visit 10)|Number of subjects analyzed (N) is the number of participants taking rescue mediation.||Number of pills||Standard Deviation|Mean
66304|NCT01147458|Secondary|Daily Diary Pain Score During Week 2 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66305|NCT01147458|Secondary|Daily Diary Pain Score During Week 1 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66306|NCT01147458|Secondary|Importance Weighted Total WOMAC Score|Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66307|NCT01147458|Secondary|WOMAC Total Score|The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66308|NCT01147458|Secondary|WOMAC Physical Function Domain Score|The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66309|NCT01147458|Secondary|WOMAC Stiffness Domain Score|The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66310|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66311|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.||Units on a scale||Standard Deviation|Mean
66312|NCT01147406|Secondary|Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration|Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).|24 hours|Any subject that received the active IMP or placebo||ng/mL||Geometric Coefficient of Variation|Geometric Mean
66313|NCT01147406|Primary|Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers|Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.|7 Days|Any subject that received active IMP or placebo||Adverse Events|||Number
66317|NCT01147380|Primary|Side Effect of Cadaveric Donor Liver NK Cell Infusion|Side effect of cadaveric donor liver NK cell infusion We will measure the occurence of the side effect of the liver NK cell infusion. We will monitor the patient condition clinically. If any side effect are noticed, we will record them and report to the data safety monitoring comittee.|1 year|||participants|||Number
66318|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
66319|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.~The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
66320|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.~Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
66321|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
66322|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
66323|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.||participants|||Number
66428|NCT01145638|Secondary|Change in Hemoglobin From Baseline to Week 24||24 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
66324|NCT01147341|Secondary|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement..|Baseline to week 12|||participants|||Number
66325|NCT01147341|Secondary|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.~The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to week 12|||participants|||Number
66326|NCT01147341|Primary|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale(VAS).~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|From Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing. 30 subjects who completed the 24 week study were included in the efficacy assessment at week 24.||participants|||Number
66327|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.~Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing.||participants|||Number
66328|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing||participants|||Number
66329|NCT01147341|Primary|Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing||participants|||Number
66338|NCT01147302|Secondary|Number of Plasmapheresis Sessions|If necessary, rescue therapy included plasmapheresis. Participating centers used plasmapheresis for desensitization, if necessary, prior to transplant and also for the treatment of acute AMR. Plasmapheresis therapy was performed for the qualifying episode of AMR according to standards at the investigational site and at the discretion of the investigator. Sessions include those prior to first dose. If plasmapheresis therapy occurred on the same day as study drug dosing, study drug was administered after completion of the plasmapheresis session.|From Day 1 through Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||sessions||Standard Deviation|Mean
66330|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||Units*h/mL||Standard Deviation|Mean
66331|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Antigen|Plasma samples were used for the determination of antigenic C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||g*h/L||Standard Deviation|Mean
66332|NCT01147302|Secondary|Time to Maximum Plasma Concentration (Tmax) of C1 INH|Plasma samples were used for the determination of antigenic and functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||hours||Full Range|Median
66333|NCT01147302|Secondary|Serum Concentrations of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||Units/mL||Standard Deviation|Mean
66334|NCT01147302|Secondary|Serum Concentrations of C1 Inhibitor (C1 INH) Antigen|Plasma samples were used for the determination of antigenic C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|||g/L||Standard Deviation|Mean
66335|NCT01147302|Secondary|Number of Participants With Allograft Failure|Allograft failure was determined by the presence of the following criteria: current renal allograft nephrectomy and/or a clinical determination that the allograft irreversibly and irrevocably ceased functioning.|From the day of enrollment to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
66336|NCT01147302|Secondary|Number of Deaths||From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
66337|NCT01147302|Secondary|Number of Participants Who Required Salvage Splenectomy|If necessary, rescue therapy included splenectomy.|From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
66352|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|12 Weeks|Safety Population||Percentage (%) of subjects|||Number
66353|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|6 Weeks|Safety Population||Percentage (%) of subjects|||Number
66339|NCT01147302|Secondary|Change From Baseline in Creatinine Clearance|Graft function was assessed by measuring creatinine clearance. Creatinine clearance was calculated by the Cockcroft-Gault formula. Baseline was the last value collected prior to first dose of study drug. A positive change from baseline indicates that the clearance rate has increased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||mL/min||Standard Deviation|Mean
66340|NCT01147302|Secondary|Change From Baseline in Serum Creatinine|Graft function was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Baseline was the last value collected prior to first dose of study drug. A negative change from baseline indicates that serum creatinine levels have decreased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||mg/dL||Standard Deviation|Mean
66341|NCT01147302|Primary|Change From Baseline in Histopathology Endpoints|The protocol-specified Day 20 (post-treatment) biopsy was compared to the qualifying biopsy to assess changes in histopathology for light and immunofluorescence microscopy. The Central Pathologist provided the following categorical information from the qualifying biopsy in an AMR Scorecard: C4d Score (0-100), Margination Score (0-100) Glomerulitis Score (0-100), Vasculitis Score (0-100), Glomerulosclerosis Score (0-100), Chronic Glomerulopathy Score (0-100), Interstitial Fibrosis Score (0-100), and the Chronic Vasculitis Score (0-100), with 0 being absence of abnormal histopathology. The “qualifying” renal allograft biopsy was performed as standard of care (SOC) within 12 months after transplant and prior to screening for this study. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy. A negative change from baseline indicates that histopathology has improved. Endpoint includes subjects with both Qualifying and Day 20 Biopsies.|Within 72 hours prior to first dose of study drug, Day 20|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||scores on a scale||Standard Deviation|Mean
66342|NCT01147302|Secondary|Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR)|The “qualifying” renal allograft biopsy was performed as standard of care within 12 months after transplant and prior to screening. The qualifying biopsy was used to establish the diagnosis of AMR and was evaluated for all of the following to obtain baseline assessments: the presence of C4d, and monocyte or neutrophil infiltration around the peritubular capillaries (PTCs) and/or glomeruli. The Central Pathologist provided the following information from the qualifying biopsy in an AMR Scorecard: C4d Score, Glomerulitis Score, Vasculitis Score, Glomerulosclerosis Score, Chronic Glomerulopathy Score, Interstitial Fibrosis Score, and the Chronic Vasculitis Score. The Banff AMR Scoring System was used to summarize these scores. Resolution determination was made based on clinical criteria (improvement of serum creatinine ± decrease of DSA titer, and/or increase in urine output) and histopathology. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy.|90 days after start of treatment|The Intent-to-Treat Safety (ITT-S) population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).||participants|||Number
66343|NCT01147250|Secondary|Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108|Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.|Baseline to Week 108 (LOCF)|ITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline UACR value. Missing data was imputed using last observation carried forward (LOCF) using the last available post-baseline UACR before Week 108 as the value at Week 108, regardless of treatment discontinuation or not.||percent change||Standard Error|Geometric Mean
66344|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure|All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.||participants|||Number
66345|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure|All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.||participants|||Number
66346|NCT01147250|Primary|Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.|From randomization up to the end of study (median follow-up of 25 months)|Intent-to-treat (ITT) population defined as all randomized participants analyzed according to the treatment group allocated at randomization.||participants|||Number
66347|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of subjects with pigmentation changes at site of injection at End of Study|24 Weeks|Safety Population||Percentage (%) of subjects|||Number
66348|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|12 Weeks|Safety Population||Percentage (%) of subjects|||Number
66349|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|6 Weeks|Safety Population||Percentage (%) of subjects|||Number
66350|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|2 Weeks|Safety Population||Percentage (%) of subjects|||Number
66351|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of subjects with keloid formation at the site of injection at End of Study|24 Weeks|Safety Population||Percentage (%) of subjects|||Number
66355|NCT01147068|Secondary|Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age|Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults|21 Days|All randomized subjects with Day 0 and Day 21 data analyzed by Cincinnati Children's Hospital Medical Center using the intent to treat population and CBER antigen.||percentage of participants||95% Confidence Interval|Number
66356|NCT01147068|Secondary|Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.|Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.|Day 0, and Day 42|All randomized subjects who received study vaccine and had Day 0 and Day 42 geometric mean titers. Analysis of results were generated by Southern Research Institute on the overall population using whole virus.||titer||95% Confidence Interval|Geometric Mean
66357|NCT01147068|Primary|Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.|42 Days|All randomized subjects who received study vaccine and had Day 0 and Day 42 efficacy data. The analysis results are generated by Southern Research Institute on the intention to treat efficacy population using whole virus.||percentage of participants||95% Confidence Interval|Number
66358|NCT01147055|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
66359|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC (0 - ∞)]|Molar ratio of metabolite to parent area under the curve from time zero to extrapolated infinite time [MRAUC (0-∞)].|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose) , 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
66360|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Ratio||Standard Deviation|Geometric Mean
66361|NCT01147055|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
66362|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
66363|NCT01147055|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of crizotinib metabolite (PF-06260182). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66364|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66365|NCT01147055|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
66366|NCT01147055|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose CL/F is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
66367|NCT01147055|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
66368|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
66369|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66370|NCT01147055|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
66371|NCT01147055|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
66372|NCT01146951|Secondary|Clinical Global Impression of Change (CGIC)|"CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward [LOCF]) & at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation [d/c]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period).~The CGIC was assessed according to the following 7-grade scale based on the frequency & severity of seizures, AEs, and overall conditions of daily life.~Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened."|Up to Week 12 of the treatment period|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||participants|||Number
66373|NCT01146951|Secondary|Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)|"Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].~Seizures analyzed other than tonic-atonic seizures included:~Partial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, & Uncla. (unclassified) epileptic seizure.~The frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Percent change||Full Range|Median
66374|NCT01146951|Secondary|Percent Change in Total Seizure Frequency (Per 28 Days)|Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Percent Change||Full Range|Median
66375|NCT01146951|Secondary|Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency|50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency.|12 weeks|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Participants|||Number
66376|NCT01146951|Primary|Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)|"The sum of the frequencies of tonic seizures and atonic seizures was defined as the “tonic-atonic seizure frequency” and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].~The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."||Percent Change||Full Range|Median
66377|NCT01146912|Primary|Influenza Immunization: Delayed Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2012|March 31, 2012|||%participants vaccinated with influenza|||Number
66378|NCT01146912|Primary|Influenza Immunization: Pregnant Women|percentage of pregnant participants with influenza immunization by December 31, 2011|by December 31, 2011|||%participants vaccinated with influenza|||Number
66379|NCT01146912|Secondary|Attendance at Appointment|percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011|September-December 2011|||% participants attending appointment|||Number
66380|NCT01146912|Secondary|Pediatric: Vaccinated at Influenza Clinic|percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011|March 31, 2011|those unvaccinated by the start date for their cohort||% participant vaccinated at flu clinic|||Number
66381|NCT01146912|Primary|Influenza Immunization: Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2011|March 31, 2011|Individuals unvaccinated by time intervention start for their cohort||% participant vaccinated with influenza|||Number
66382|NCT01146873|Secondary|Highest Grade ALT After Randomization|Highest grade ALT after randomization. Grading was determined based on the Division of AIDS (2004) Toxicity Tables to grade adverse reactions. Grading scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (potentially life-threatening).|through 48 weeks post randomization|||number of participants|||Number
66383|NCT01146873|Secondary|Percentage of Participants With Elevated Total Cholesterol, Elevated LDL, Abnormal HDL, or Abnormal Triglycerides at 40 Weeks After Randomization|Percentage of participants with elevated total cholesterol, elevated LDL, abnormal HDL, or abnormal triglycerides at 40 weeks after randomization|40 weeks|||percentage of participants|||Number
66384|NCT01146873|Secondary|CD4 Cell Percentage at 48 Weeks After Randomization|CD4 Cell Percentage at 48 Weeks After Randomization|48 weeks|||percentage of cells||95% Confidence Interval|Mean
66385|NCT01146873|Primary|Viral Failure|Probability of viral failure defined as >= 2 HIV RNA measurements >1000 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks|||probability of viral failure||95% Confidence Interval|Mean
66386|NCT01146873|Primary|Viral Rebound|Probability of viral rebound defined as >=1 HIV RNA measurements >50 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks|||probability of viral rebound||95% Confidence Interval|Mean
66387|NCT01146860|Secondary|Ultrasonography of Paranasal Sinuses|Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses will be evaluated. Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis.|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||percentage of patients|||Number
66388|NCT01146860|Secondary|Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale|"General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as responders to treatment. Patients whose symptoms are unchanged or deteriorated as classified as non-responders."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||percentage of patients|||Number
66389|NCT01146860|Secondary|Major Symptom Score Assessed by the Patient|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.~Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.~Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||units on a scale||Standard Error|Mean
66390|NCT01146860|Secondary|SNOT 20 Symptom Scores|"Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be.~range: 0 to 100"|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||units on a scale (range: 0 - 100)||Standard Deviation|Mean
66427|NCT01145755|Primary|MADRS Total Score Change From Baseline to Week 6|Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.|6 weeks|||scores on the scale||Standard Deviation|Mean
66391|NCT01146860|Primary|Major Symptom Score (MSS) Assessed by the Investigator|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.~Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.~Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data||units on a scale||Standard Error|Mean
66392|NCT01146782|Secondary|Percent Reduction in Oxygen Desaturation Index (ODI)|Comparing first treatment night to control/baseline night reported as percent change. Negative numbers represent a reduction/improvement in ODI, whereas positive numbers represent increases/no improvement in ODI.|First treatment night|||ODI reduction (% change)||Inter-Quartile Range|Median
66393|NCT01146782|Secondary|Last Treatment Night Response (AHI Reduction)|Comparing AHI at the last treatment night to the control/baseline night is reported as the percent change in AHI. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. Negative numbers represent a decrease/improvement in AHI, whereas positive numbers represent an increase/no improvement in AHI.|At completion of 28 day home use.|All subjects in primary endpoint cohort with final evaluable treatment PSG.||AHI reduction (% change)||Inter-Quartile Range|Median
66394|NCT01146782|Secondary|Adverse Event Rate|Further categorized as serious and non-serious, device-related and non-device-related, unanticipated and anticipated, and based on level of severity. Adverse events will be evaluated during the trial at the following visits during 28-day take-home period: 7-day, 14-day, 21-day, 28-day follow-up, and any unscheduled visits.|4 weeks|The Safety Cohort consisted of all subjects who participated in at-home use of the device.||subjects|||Number
66395|NCT01146782|Primary|Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20|Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.|first treatment night|All subjects in the primary endpoint cohort were analyzed.||subjects with clinical success|||Number
66396|NCT01146613|Primary|Weekly Percentage of Heavy Drinking Days|Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.|Weeks 2-13*|||percentage of heavy drinking days||Standard Error|Mean
66397|NCT01146600|Secondary|Reported Adverse Events||baseline, week 1, week 2||||||
66398|NCT01146600|Secondary|PSQI|"Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
66399|NCT01146600|Secondary|SF-36, Vitality Subscale|"The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
66400|NCT01146600|Secondary|FOSQ|"Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
66401|NCT01146600|Secondary|Epworth Sleepiness Scale|"Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||units on a scale||Standard Deviation|Mean
66402|NCT01146600|Secondary|PVT Number of Lapses|Number of lapses (no response for > 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance.|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||Number of lapses||Standard Deviation|Mean
66403|NCT01146600|Secondary|PVT Median Reaction Time at Week 1|"median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance)~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)"|week 1|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||Msec||Standard Deviation|Mean
88106|NCT00928083|Secondary|OZ439 Tmax|Time to maximum observed plasma drug concentration of OZ439|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||hours||Full Range|Median
66404|NCT01146600|Primary|Psychomotor Vigilance Task (PVT) Reaction Time|"Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance).~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)"|week 2 of each intervention|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)||Msec||Standard Deviation|Mean
66405|NCT01146418|Secondary|Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)|The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.|From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)|FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.||Percentage of Participants||95% Confidence Interval|Number
66406|NCT01146418|Primary|Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)|The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).|Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)|Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.||Percentage of Participants||95% Confidence Interval|Number
66407|NCT01146288|Primary|Renal Vascular Resistance (mm Hg/[ml/Min])||baseline and after diuretics administration|||mm Hg/[ml/min]||Standard Deviation|Mean
66408|NCT01146288|Primary|Change in GFR (ml/Min)||baseline and after diuretics administration|||ml/min||Standard Deviation|Mean
66409|NCT01146275|Primary|To Evaluate the Long Term Safety of Macrolane in Breast Enhancement|"To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation.~Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"|7 years +/- 6 months post treatment|Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study.||participants|||Number
66410|NCT01146275|Primary|To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation|The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.|7 years +/- 6months post treatment|MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI.||participants with remaining product|||Number
66411|NCT01145898|Primary|3-year Change in OPP|Measurement of change in ocular perfusion pressure|Baseline and 36 month visits|||mm Hg||Standard Error|Mean
66412|NCT01145898|Primary|3-year Change in CRA RI|Measurement of change in ocular blood flow - central retinal arteries resistance index|Baseline and 36 month visits|||unitless||Standard Error|Mean
66413|NCT01145898|Primary|3-year Change in CRA EDV|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
66414|NCT01145898|Primary|3-year Change in CRA PSV|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
66415|NCT01145898|Primary|3-year Change in OA RI|Measurement of change in ocular blood flow - ophthalmic artery resistance index|Baseline and 36 month visits|||unitless||Standard Error|Mean
66416|NCT01145898|Primary|3-year Change in OA EDV|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
66417|NCT01145898|Primary|3-year Change in OA PSV|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 36 month visits|||cm/sec||Standard Error|Mean
66418|NCT01145898|Primary|6-month Change in Ocular Perfusion Pressures (OPP)|Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.|Baseline and 6 month visits|||mm Hg||Standard Error|Mean
66419|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits|||unitless||Standard Error|Mean
66420|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
66421|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
66422|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits|||unitless||Standard Error|Mean
66423|NCT01145898|Primary|6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
66424|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 6 month visits|||cm/sec||Standard Error|Mean
66425|NCT01145755|Secondary|MADRS Remission|A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6|6 weeks|||Participants|||Number
66429|NCT01145638|Primary|Change in Hb Concentration||Baseline week 4|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
66430|NCT01145625|Other Pre-specified|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 52|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.||hairs per centimeter squared||Standard Deviation|Mean
66431|NCT01145625|Secondary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography|Baseline to Week 12|Intent-to-Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.||hairs per centimeter squared||Standard Deviation|Mean
66432|NCT01145625|Primary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.||hairs per centimeter squared||Standard Deviation|Mean
66433|NCT01145560|Secondary|Safety and Tolerability|Number of patients with treatment-emergent adverse events|All study visits (over 90 days following first dose)|Safety Analysis Set||Participants|||Number
66434|NCT01145560|Secondary|28-day Mortality|Number of patients who died over 28 days|Over 28 days following first dose|Intention-to-treat analysis set||Participants|||Number
66435|NCT01145560|Secondary|7-day Mortality|Number of patients who died over 7 days|Over 7 days following first dose|Intention-to-treat analysis set||Participants|||Number
66436|NCT01145560|Primary|Ventilator-free Days (VFDs) Over 28 Days|Number of ventilator-free days (VFDs)|Over 28 days following first dose|Intention-to-treat analysis set||Days||Full Range|Median
66437|NCT01145547|Primary|Mean Area Under the Curve for Rise in Breakfast Post-prandial.|Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.|Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast|||min x (mmol/l)||Standard Deviation|Mean
66438|NCT01145508|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or the date of last known alive.|Assessed every 3 months for 2 years, and then every 6 months for 3 years|All randomized patients are included in the analysis.||Months||95% Confidence Interval|Median
66439|NCT01145495|Secondary|Time to Best Response|Kaplan-Meier method will be used.|Up to 10 years||||||
66440|NCT01145495|Secondary|Time to Disease Progression|Kaplan-Meier method will be used.|Up to 10 years||||||
66441|NCT01145495|Secondary|Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Data will be summarized using frequency tables.|Up to 10 years||||||
66442|NCT01145495|Primary|Number of Participants Who Achieved a Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|At 12 months|At the time of analysis, 54 participants had adequate to evaluate response.||participants|||Number
66443|NCT01145482|Secondary|Memory|Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance|15 minutes post insulin or placebo administration|||units on a scale||Standard Deviation|Mean
66444|NCT01145482|Primary|Cerebral Glutamate Concentration|Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.|15 minutes post insulin or placebo administration|per protocol||ratio||Standard Deviation|Mean
66445|NCT01145417|Secondary|Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)|PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated “Over past 2 weeks, how often bothered by any of following problems?”: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.|Baseline|SAF population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
66446|NCT01145417|Secondary|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Baseline up to Week 25|SAF included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.||participants|||Number
66447|NCT01145417|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
66448|NCT01145417|Secondary|Visual Analogue Scale for Pain (VAS-pain)|Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, 8, 12, 16, 20, 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants who were evaluable at specific time points for each arm group, respectively.||millimeter (mm)||Standard Deviation|Mean
66449|NCT01145417|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Week 24|ITT population included all enrolled participants who took at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific parameter for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
66450|NCT01145417|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
66451|NCT01145417|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.||hours||Standard Deviation|Mean
66452|NCT01145417|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded “Yes/No” to Question 1: Are you currently employed (working for pay)? are reported.|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for each arm group, respectively.||participants|||Number
66453|NCT01145417|Primary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study treatment|Safety population (SAF) included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.||participants|||Number
66454|NCT01145391|Secondary|Clinical Inertia|"Definition of clinical inertia: failure of a primary care physician to initiate/intensify anti-hypertensive medications AND the failure to provide behavioral counseling to lower blood pressure during a clinic visit where blood pressure is elevated above 140/90 mm Hg. The clinical inertia measure is the percentage of clinic visits with clinical inertia present divided by the total number of clinic visits.~We report a change in group mean levels of clinical inertia from baseline to 9 months post-randomization. Negative values for clinical inertia represent a decrease in the percentage of clinic visits where clinical inertia was present. Pre-randomization clinical inertia was assessed in the last 2 clinic visits prior to randomization, and post-randomization inertia was assessed in the first 2 post-randomization visits.~Hypothesis: clinical inertia will be significantly greater in the usual care compared with intervention group in the post-randomization period."|Baseline, 9 months|||% visits with inertia present||95% Confidence Interval|Number
66455|NCT01145391|Primary|Blood Pressure|Hypothesis: compared with patients who receive usual care, patients who receive intervention will have an average systolic blood pressure that is at least 5 points lower 9 months after randomization.|Baseline, 9 months|Intention-to-treat analyses using restricted maximum likelihood (REML) for a repeated measures model with incomplete data (SAS Proc Mixed). As this assumes that the occurrence of missing follow-up data depends only on observed data (i.e., pre-randomization values), we also performed a sensitivity analysis using the method proposed by Little.||mm Hg||95% Confidence Interval|Mean
66456|NCT01144299|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period (From Day 0 up to Day 21)|||subjects|||Number
66457|NCT01144299|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
66458|NCT01144299|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data||subjects|||Number
66459|NCT01144299|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data||subjects|||Number
66460|NCT01144299|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
66461|NCT01144299|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||fold increase||95% Confidence Interval|Mean
66462|NCT01144299|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
66463|NCT01144299|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
66464|NCT01144299|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data||titer||95% Confidence Interval|Geometric Mean
66465|NCT01144286|Secondary|Dose-response of Clinical and Mycological (Global)Therapeutic Response|Global therapeutic response at day 8± 2 days. Safety and tolerability.|Day 8 ± 2 days|Dose response tested using logistic regression-linear coefficient for treatment effect.Assuming response rate 80% for 600 mg, 75% for 300 mg, 65% for 150 mg and 50% for the placebo group, sample size of 45 subjects in each group have 90% power to detect linear dose response with 0.05 two-sided test of trend based on the logistic model.||percentage of cured participants||95% Confidence Interval|Number
66466|NCT01144286|Primary|Dose-response of Clinical and Mycological (Global) Therapeutic Response|"Global therapeutic response at day 26± 4 days (TOC- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline Vulvovaginal Candidiasis —Developing Antimicrobial Drugs for Treatment."|day 26 ± 4 days|The full analysis set (FAS) was the primary population for the analysis of all efficacy endpoints. The FAS was defined as all randomized subjects who received at least 1 dose of a study drug.Subjects in the FAS were analyzed according to randomized treatment group.||percentage of patients cured||95% Confidence Interval|Number
66467|NCT01145352|Secondary|Percentage of Participants With Overall Improvement On Physician's Assessment.|Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.||percent||95% Confidence Interval|Number
66468|NCT01145352|Primary|Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.||Percentage of participants||95% Confidence Interval|Number
66469|NCT01145352|Primary|Number of Unlisted Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.||events|||Number
66470|NCT01145352|Primary|Number of Participants With Serious Treatment-Related Adverse Events of Etanercept|Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.||participants|||Number
66505|NCT01144598|Secondary|Evaluation of Global Rheumatoid Arthritis Severity Scale|Global rheumatoid arthritis severity was assessed by asking the participants to consider all the ways their rheumatoid arthritis affected them and to rate how they were doing on a scale of 0 (very well) to 10 (very poor).|Day 1|All participants with available information were included in the analysis.||Units on a scale||Standard Deviation|Mean
66471|NCT01145352|Primary|Number of Participants With Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.||participants|||Number
66472|NCT01145053|Secondary|Nocturnal Sleep|Nocturnal Sleep is rating 1 to 5 score based on patient’s diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 308 patients recorded the Nocturnal Sleep.||Units on a scale||Standard Deviation|Mean
66473|NCT01145053|Secondary|Shortness of Breath|Shortness of Breath is rating 1 to 6 score based on patient’s diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Shortness of Breath.||Units on a scale||Standard Deviation|Mean
66474|NCT01145053|Secondary|Amount of Sputum|Amount of Sputum is rating 1 to 4 score based on patient’s diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Amount of Sputum.||Units on a scale||Standard Deviation|Mean
66475|NCT01145053|Secondary|Cough Frequency|Cough frequency is rating 1 to 4 score based on patient’s diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Cough Frequency .||Units on a scale||Standard Deviation|Mean
66476|NCT01145053|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 105 patients measured FEV1 .||L||Standard Deviation|Mean
66477|NCT01145053|Secondary|Effectiveness|Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.|Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set.||Patients|||Number
66478|NCT01145053|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients||Patients|||Number
66479|NCT01145001|Secondary|Continuous Abstinence During Treatment|We will also examine continuous abstinence during the six week treatment period by urine analysis each week.|6 weeks|this is the intent to treat group-all starters (not treatment completers)||consecutive days of abstinence||Standard Deviation|Mean
66480|NCT01145001|Primary|Abstinence Rates at the End of Treatment|Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.|6 weeks|||percentage of participants not smoking|||Number
66481|NCT01144949|Secondary|Time to Spontaneous Stone Passage (All Stones)|Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.|4 weeks|ITT population||days||Standard Error|Mean
66482|NCT01144949|Primary|Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.|4 weeks|This endpoint analyzed all subjects in the ITT population, defined as randomized and received at least one dose of study drug (115 in the 8 mg silodosin arm, 117 in the placebo arm)||participants|||Number
66483|NCT01144949|Secondary|Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)|At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject’s daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.||units on a scale||Standard Deviation|Mean
66484|NCT01144949|Secondary|Outpatient Narcotic Analgesic Use for Pain Relief|Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.|4 weeks|ITT population||Days||Standard Deviation|Mean
66485|NCT01144949|Secondary|Time to Spontaneous Stone Passage (Distal Stones)|Time to stone passage for distally-located stones is assessed by entries in subject diaries.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.||days||Standard Error|Mean
102035|NCT00797316|Primary|Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set||mm Hg||Standard Error|Least Squares Mean
66486|NCT01144949|Primary|Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|"The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography.~For this outcome measure, analysis includes only those stones located in the distal ureter."|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.||participants|||Number
66487|NCT01144715|Secondary|Stroke Impact Scale (SIS)|Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.|End of treatment at 8 weeks post enrolment|||units on a scale||Standard Deviation|Mean
66488|NCT01144715|Secondary|Fugl-Meyer Upper Extremity Test|Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0–2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.|End of Treatment at 8 weeks post enrolment|||units on a scale||Standard Deviation|Mean
66489|NCT01144715|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.|End of treatment at 8 weeks post enrolment|||Seconds||Standard Deviation|Geometric Mean
66490|NCT01144715|Primary|Action Research Arm Test (ARAT)|The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.|End of treatment at 8 weeks post enrolment|||units on a scale||Standard Deviation|Mean
66491|NCT01144624|Secondary|Pharmacodynamic Effects of AZD9773 on TNF-alpha|TNF-alpha levels over approximately 6 days following the first dose|Levels taken at baseline, over the dosing period (up to Day 5/6)|Safety analysis set||pg/ml||Full Range|Median
66492|NCT01144624|Primary|Pharmacokinetics of AZD9773|Maximum concentration at steady state (Cmax ss) for serum total and specific fabs|From first dose to last dose (Day 5/6 or at premature treatment discontinuation)|Pharmacokinetic analysis set||ug/mL||Full Range|Geometric Mean
66493|NCT01144624|Primary|Safety and Tolerability of AZD9773|Number of patients with treatment-emergent adverse events and number of patients who died over 28 days|28 day study period|Safety analysis set||Participants|||Number
66494|NCT01144598|Secondary|Evaluation of Rheumatoid Arthritis Treatments Duration|Time elapsed from onset of symptoms to diagnosis of rheumatoid arthritis (that is, from the first rheumatoid arthritis-related symptoms to diagnosis by a related specialist) and the time elapsed from diagnosis with rheumatoid arthritis to initiation of anti-tumor necrosis factor (anti-TNF) treatment.|Day 1|All participants with available information were included in the analysis.||Months||Standard Deviation|Mean
66495|NCT01144598|Secondary|Number of Deformities at Inspection|The number of joint deformities of the study participants.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66496|NCT01144598|Secondary|Sedimentation Rate|The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.|Day 1|All participants with available information were included in the analysis.||millimeters/hour||Standard Deviation|Mean
66497|NCT01144598|Secondary|Anti-cyclic Citrullinated Peptide|Anti-cyclic citrullinated peptide (anti-CCP) test results.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66498|NCT01144598|Secondary|Rheumatoid Factor|Rheumatoid factor test results.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66499|NCT01144598|Secondary|Number of Comorbidities|Number of comorbid (coexisting) medical conditions of the study participants.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66500|NCT01144598|Secondary|Stiffness Duration|Participants' duration of morning joint stiffness.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66501|NCT01144598|Secondary|Biologics Usage|Biologic treatments participants were taking for their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66502|NCT01144598|Secondary|Number of Disease Modifying Anti-Rheumatic Drugs|The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66503|NCT01144598|Secondary|Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue|Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case.|Day 1|Participants who provided a visual analog scale rating for pain and fatigue were included in the analysis.||Units on a scale||Standard Deviation|Mean
66504|NCT01144598|Secondary|Evaluation of Disease Activity Score 28 (DAS28)|"The DAS28 index measures disease activity in rheumatoid arthritis and is derived from the number of swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 100 mm line from very good to very bad). A higher score indicates worse control of disease. A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity."|Day 1|All participants with available information were included in the analysis.||Participants|||Number
66506|NCT01144598|Secondary|Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire|The WPAI evaluates the ability to work and perform regular activities. The scale yields 4 types of scores (range 0 to 100): Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.||Units on a scale||Standard Deviation|Mean
66507|NCT01144598|Secondary|Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI measures physical function by assessing the ability to perform daily living tasks. Each task is rated from 0 (no difficulty) to 3 (unable to do). The total score ranges from 0 to 3. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.||Units on a scale||Standard Deviation|Mean
66508|NCT01144598|Primary|Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis|The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).|Day 1|All participants with available information were included in the analysis.||Months||Standard Deviation|Mean
66509|NCT01144442|Primary|Feasibility of HIPC in Recurrent Disease Setting|We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.|6 months|||participants|||Number
66510|NCT01144442|Secondary|Overall Survival|Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.|Up to 5 Years||||||
66511|NCT01144442|Secondary|Progression-free Survival|Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).|Up to 5 Years||||||
66512|NCT01144442|Secondary|Quality of Life Measurements|The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.|Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27||||||
66513|NCT01144442|Primary|Clinical Response|We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.|After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)|||participants|||Number
66514|NCT01144416|Secondary|Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event|The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.|Up to time of embryo transfer (maximum of 24 days after start of study drug)|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.||participants|||Number
66515|NCT01144416|Secondary|Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)|"Grade II (moderate OHSS) is characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea.~Grade III (severe OHSS) is characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm, may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause hemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena."|Up to approximately 1 month after oocyte pick-up|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.||participants|||Number
66516|NCT01144416|Secondary|Live Birth Rate|The live-birth rate is the percentage of participants with at least 1 live born infant after an ongoing pregnancy in the controlled ovarian stimulation (COS)treatment cycle relative to the number of participants treated.|Approximately nine months after embryo transfer|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to.||Percentage of participants|||Number
66517|NCT01144416|Secondary|Number of Oocytes Retrieved Per Attempt|The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).|Maximally 21 days after the start of study treatment.|Intent-To-Treat (ITT) Group, defined as all randomized participants who received one or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. The number of oocytes retrieved were set to zero for participants who did not have oocyte retrieval.||Number of oocytes||Standard Deviation|Mean
66518|NCT01144416|Primary|Percentage of Participants With a Vital Pregnancy|Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle|Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days.|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. Participants who did not have embryo transfer or who were lost to follow-up before the ultrasound assessment to confirm vital pregnancy were counted as non-pregnant.||percentage of participants|||Number
66519|NCT01144403|Secondary|Number of Participant With Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to 50 months (approximately)|Safety population included all the participants who had received at least one dose of study treatment.||participants|||Number
66548|NCT01144052|Secondary|Number of Patients With Adverse Events|Recording and reporting according to regulations. Monthly assessments or if necessary.|12 months|All patients enrolled and randomized were analyzed.||participants|||Number
66520|NCT01144403|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.||days||95% Confidence Interval|Median
66521|NCT01144403|Secondary|Overall Survival (OS)|Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.||days||95% Confidence Interval|Median
66522|NCT01144403|Primary|Overall Response Rate (ORR)|Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.|Up to 50 months (approximately)|Efficacy population included all the participants who had received at least one dose of study treatment.||percentage of participants|||Number
66523|NCT01144364|Secondary|Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months|DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.|Months 12, 24, and 34|ITT Population||percentage of participants||95% Confidence Interval|Number
66524|NCT01144364|Secondary|Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months|Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.|Months 12, 24, and 34|ITT Population||percentage of participants||95% Confidence Interval|Number
66525|NCT01144364|Secondary|Percentage of Participants With a Molecular Response in the Induction Phase|Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.|Months 5 and 8|IP population; only participants with a positive bcl-2/IgH (NHL marker) at baseline were included in the analysis.||percentage of participants|||Number
66526|NCT01144364|Secondary|Percentage of Participants With a Response During the Induction Phase|Participants without a response assessment (due to any reasons) were considered as non-responders.|Months 1 to 8|ITT population.||percentage of participants|||Number
66527|NCT01144364|Primary|PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.|12, 24, and 34 months|ITT population||percentage of participants||95% Confidence Interval|Number
66528|NCT01144364|Secondary|OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months|OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population||percentage of participants||95% Confidence Interval|Number
66529|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants With Death|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.||percentage of participants|||Number
66530|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.||percentage of participants||95% Confidence Interval|Number
66531|NCT01144364|Secondary|Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months|DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.|12, 24, and 36 months|ITT population||percentage of participants||95% Confidence Interval|Number
66549|NCT01144052|Secondary|MRI Parameters|Number of new T2-hyperintense lesions, Number of Gd-enhancing lesions on T1-weighted images. Assessments at month 3, 6, 9, 12, 18, 24.|12 months|All enrolled and randomized patients were analyzed.||Lesions||Full Range|Median
66532|NCT01144364|Secondary|Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months|PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population||percentage of participants||95% Confidence Interval|Number
66533|NCT01144364|Primary|Percentage of Participants With Disease Progression or Death|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.|12, 24, and 34 months|ITT population||percentage of participants|||Number
66534|NCT01144182|Secondary|Emotional Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-25, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66535|NCT01144182|Primary|Heart Failure Specific Quality of Life|Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the MLHFQ, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66536|NCT01144182|Secondary|Physical Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-40, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66537|NCT01144182|Primary|General Quality of Life From the Standardized Physical Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66538|NCT01144182|Secondary|Mental Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66539|NCT01144182|Secondary|Role Emotional|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66540|NCT01144182|Secondary|Social Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66541|NCT01144182|Secondary|Vitality|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66542|NCT01144182|Secondary|General Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66543|NCT01144182|Secondary|Pain Index|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66544|NCT01144182|Secondary|Role Physical|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36. Additionally, a second participant in CBP did not complete the role physical subscale items, leaving a total of 49 in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66545|NCT01144182|Secondary|Physical Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66546|NCT01144182|Secondary|Standardized Mental Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.||units on a scale||Inter-Quartile Range|Median
66547|NCT01144052|Secondary|Number of Infections||12 months|||events|||Number
66556|NCT01143896|Primary|Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months|The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value.|From Baseline to 12 months|||Depression Free Days (DFDs)||Standard Deviation|Mean
66557|NCT01143896|Primary|Depression Care: Depression Remission|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5.|Baseline and 12 months|||participants|||Number
66558|NCT01143896|Primary|Depression Care: Treatment Response|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline.|Baseline and 12 months|||participants|||Number
66559|NCT01143896|Secondary|Medication Adherence: Medication Possession Ratio|Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day’s supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement.|12 months|||medication posession ratio||Standard Deviation|Mean
66560|NCT01143896|Secondary|Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received|Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe.|12 months|||proportion of QIs met||Standard Deviation|Mean
66561|NCT01143896|Primary|Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment|Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise.|12 months|intent to treat||participants|||Number
66562|NCT01143883|Primary|Surgical Site Infection|We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.|Day of surgery up to 30 days post operatively|The number of participants analyzed was based on the number who received treatment according to their randomized group and were treated according to study protocol||percentage of participants with SSI|||Number
66563|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in Body Mass Index (BMI)|The BMI was measured in kg/m^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/[(height (m) x height (m)] and was measured to 1 decimal point precision.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had BMI available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
66564|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score|The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=[(MFI value at Month 6-MFI value at baseline)/MFI baseline value] X 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an MFI score available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
66565|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score|The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = [(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value]x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an IIEF score available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
66566|NCT01143818|Primary|Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score|The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an Aging Male Symptoms (AMS) score available at baseline and Month 6.||Percent Change||Standard Deviation|Mean
66567|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior six months|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.||percent days of drug use||Standard Deviation|Mean
103167|NCT00789724|Secondary|Difference Between the 2 Arms in Change in the Number of Circulating Endothelial Progenitor Cells From Baseline to Follow up Exam||10-14 weeks||||||
66568|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||percent days of drug use||Standard Deviation|Mean
66569|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
66570|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
66571|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||units on a scale||Standard Deviation|Mean
66572|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior six months.|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||participants who always used condoms|||Number
66573|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||participants who always used condoms|||Number
66574|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||participants who always used condom|||Number
66575|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.||percent days of drug use||Standard Deviation|Mean
66576|NCT01143766|Secondary|Efficacy|Assess the effect of a single 900mg dose of gabapentin pre-ERCP on pre and post procedure pain, anxiety and nausea as reported on visual analog scales.|At time of discharge post-procedure||||||
66577|NCT01143766|Secondary|Safety|Measure sedation-related adverse events|At time of discharge post-procedure||||||
66578|NCT01143766|Primary|Dosing Requirements|Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.|At time of discharge post-procedure|TOTAL DOSE OF MEPERIDINE||TOTAL DOSE OF MEPERIDINE, mg||Inter-Quartile Range|Median
66579|NCT01143727|Secondary|Percent Change in Wound Area||28 days|Intent-to-Treat||percentage change from baseline area||Standard Deviation|Mean
66580|NCT01143727|Primary|Wound Appearance|Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.|28 days|12 subjects initially for this exploratory study. 17 subjects enrolled to ensure 12 evaluable. Intent-to-treat used for primary inference. Missing values imputed by method of population mean (BWAT-m) and last observation carried forward (wound area).||units on a scale||Standard Deviation|Mean
66581|NCT01143714|Secondary|Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)||12 weeks|Intent-to-Treat population||debridements||Standard Error|Least Squares Mean
66582|NCT01143714|Primary|Change in Wound Area|The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period|4 Weeks|Sample size originally set at 100 to provide 80% power, a=0.05. Interim analysis when enrollment reached 50 indicated results would not change with additional enrollment. Intent-to-treat used for primary inference; Missing values imputed by method of population mean and last observation carried forward (wound area).||percentage of average change in wound||Standard Error|Least Squares Mean
66583|NCT01143701|Primary|Teacher-rated ADHD Symptoms|Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Analyses only included patients who had a post-intervention teacher-rated ADHD scale. Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.||scores on a scale|Participants|Standard Deviation|Mean
66584|NCT01143701|Primary|Parent-rated ADHD Symptoms|Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.||scores on a scale|Participants|Standard Deviation|Mean
66585|NCT01143610|Secondary|Gain of Clinical Attachment Level|Investigation of clinical attachment level, probing depth and reduction of recession depth|9 months post-operatively|The unit of analysis was the site, since each participant contributed with more than one site to be treated||mm|Participants|Standard Deviation|Mean
66586|NCT01143610|Primary|Percentage of Root Coverage|Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)|Baseline, 9 months post-operatively|The unity of analysis was the site, since each participant contributed with more than one site for treatment||percentage of area covered|Participants|Full Range|Mean
66600|NCT01143324|Secondary|Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.|Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.|12 months|One hundred and thirty one-level patients (=130 LEVELS) and 24 two-level patients (=48 LEVELS) were assessed for fusion at 12 months per CIP defined criteria.||Fused levels|Participants||Number
66587|NCT01143337|Secondary|Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|ACR components are tender joints count (TJC), swollen joints count (SJC), participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ‐DI]); and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|LOCF (Week 12 or discontinuation time)|||percentage of change from baseline||Standard Deviation|Mean
66588|NCT01143337|Secondary|Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|"DAS28 (CRP) is calculated using TJC, SJC C-Reactive Protein ( CRP in mg/dL ), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity.~DAS28 (ESR) is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.~A negative change score indicates improvement. Higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity."|LOCF (Week 12 or discontinuation time)|||units on a scale||Standard Deviation|Mean
66589|NCT01143337|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response|ACR 70 response is a decrease of at least 70 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)|||percentage of participants||95% Confidence Interval|Number
66590|NCT01143337|Secondary|Percentage of Participants Achieving ACR 50 Response|ACR 50 response is a decrease of at least 50 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)|||percentage of participants||95% Confidence Interval|Number
66591|NCT01143337|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count [TJC and SJC] and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ-DI]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)|||percentage of participants||95% Confidence Interval|Number
66592|NCT01143324|Primary|Time to Surgery Recovery Day.|"The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.~Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors."|From date of surgery until date of surgery recovery day assessed up to hospital discharge.|||Days||Standard Deviation|Mean
66593|NCT01143324|Secondary|Number of Patients That Returned to Work 12months After the Surgery.|Document number of participants that returned to work 12 months after surgery.|12 months after the surgery|||Participants currently working|||Number
66594|NCT01143324|Secondary|ODI Difference 12 Months After the Surgery as Compared to Baseline.|Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|Baseline, 12 months|||Units on a scale||Standard Deviation|Mean
66595|NCT01143324|Secondary|Document Adverse Events Occurrence Throughout the Study.|Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.|From Baseline until 12 months|||Number of reported adverse events|||Number
66596|NCT01143324|Secondary|Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.|Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit.|Baseline, 12 months|||Participants|||Number
66597|NCT01143324|Secondary|Proportion of Patients Needing Intervention at Adjacent Level(s).|Proportion of the patients needing intervention at adjacent level(s).|From Baseline until 12 months|||Participants|||Number
66598|NCT01143324|Secondary|Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).|Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates).|From baseline until 12 months|||Participants|||Number
66599|NCT01143324|Secondary|Number of Patients Who Utilized Rehabilitation Programs|The number of patients who utilized rehabilitation programs was documented (when required).|From 6-12 months after the day of surgery|||Pts having rehab between 6-12 months|||Number
66724|NCT01142297|Primary|Implant Stability Quotient (ISQ)|resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.|4 months|||units on a scale||Standard Error|Mean
66601|NCT01143324|Secondary|EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.|EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent’s self-rated health on a vertical 20 cm VAS where the endpoints are labelled ‘Best imaginable health state’ at the top and ‘Worst imaginable health state’ at the bottom, having numeric values of 100 and 0 respectively.|Baseline, 12 months|||Units on a scale / Index||Standard Deviation|Mean
66602|NCT01143324|Secondary|Leg Pain Intensity VAS Score as Compared to Baseline|"Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).~The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months|||Units on a scale||Standard Deviation|Mean
66603|NCT01143324|Secondary|Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.|"Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).~The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months|||Units on a scale||Standard Deviation|Mean
66604|NCT01143324|Primary|Time From Surgery to First Ambulation.|"The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.~Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital."|From date of Surgery to date of First ambulation, assessed up to hospital discharge.|||Days from surgery to first ambulation||Standard Deviation|Mean
66605|NCT01143272|Secondary|Total Number of Discontinuation or Change of Initially Prescribed Antibiotic||29 months|||participants|||Number
66606|NCT01143272|Secondary|Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months|||bowel movements per day||Standard Deviation|Mean
66607|NCT01143272|Secondary|Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months|||days||Standard Deviation|Mean
66608|NCT01143272|Secondary|Incidence Density of Antibiotic-associated Diarrhea||29 months|||cases per year|||Number
66609|NCT01143272|Secondary|Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins)||29 months|||episodes|||Number
66610|NCT01143272|Secondary|Total Number of Clostridium Difficile-associated Diarrhea Episodes||29 months|||episodes|||Number
66611|NCT01143272|Primary|Total Number of Antibiotic-associated Diarrhea Episodes||29 months|||Episodes|||Number
66612|NCT01143259|Secondary|Hospital Cost|Total Cost of hospital stay inflation adjusted to 2010 dollars.|Upon discharge|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.||Dollars||Full Range|Mean
66613|NCT01143259|Primary|Measure of Improvement Over the Standard|Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.|Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.||Days in the hospital||Full Range|Mean
66614|NCT01143207|Primary|MPA Concentration at Day 120 (C120)||day 120 after injection|||ng/mL||Standard Deviation|Mean
66615|NCT01143207|Primary|MPA Concentration at Day 104 (C104)||day 104 after injection|||ng/mL||Standard Deviation|Mean
66616|NCT01143207|Primary|MPA Concentration at Day 91 (C91)||day 91 after first injection|||ng/mL||Standard Deviation|Mean
66617|NCT01143207|Primary|AUC 0-91 (Area Under Curve)||first 91 days following injection|||ng day/mL||Standard Deviation|Mean
66618|NCT01143207|Primary|Tmax (Time to Cmax)||120 days following injection|||days||Inter-Quartile Range|Median
66619|NCT01143207|Primary|Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))||120 days following injection|||ng/mL||Standard Deviation|Mean
66620|NCT01143142|Secondary|Vaccination of Daughter|With mother’s consent, daughter’s University of Michigan vaccination record will be accessed to determine whether daughter has received any doses of the HPV vaccine. If the University of Michigan vaccination record does not document a visit three months after the intervention, with mother’s consent, research staff will call mother at home to determine whether daughter has received any doses of the HPV vaccine.|Less than or equal to three months from the date of the intervention|||participants|||Number
67711|NCT01130844|Primary|Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over a 24-hour period starting on day 7|PKS||hours||Full Range|Median
66621|NCT01143142|Primary|Mother's Intention to Vaccinate Daughter Against HPV|Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention. The scale ranges from 0-11 with higher numbers representing more positive intentions to vaccinate against HPV, and 5 being neutral intentions (i.e. neither positive nor negative). In this assessment we use this 11-point scale to assess vaccination before and after viewing the educational materials. The difference pre and post intervention in vaccination intention is calculated (min 0, max 11) and the mean of these differences are calculated for the control and intervention groups.|Date of intervention (one day)|||units on a scale||Full Range|Mean
66622|NCT01143090|Secondary|Efficacy|Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289|6 months||||||
66623|NCT01143090|Primary|Adverse Events|Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.|6 months|Safety population - One enrolled subject did not receive any study medication and was excluded from this summary.||participants|||Number
66624|NCT01143077|Secondary|Tolerability and Safety|Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events|6 Weeks|||participants|||Number
66625|NCT01143077|Primary|Time to Relapse of Psychotic Symptoms During 6 Weeks|"Relapse is defined as any occurrence of:~Insufficient clinical response~Exacerbation of underlying disease~Discontinuation due to an adverse event"|6 Weeks|Intend to treat||days||Standard Deviation|Mean
66626|NCT01143051|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 minutes post-dose available and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
66627|NCT01143051|Primary|Half-life (t1/2) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 min post-dose available; and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Full Range|Mean
66628|NCT01143051|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||min||Standard Deviation|Mean
66629|NCT01143051|Primary|Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
66630|NCT01143051|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg*min/mL||Standard Deviation|Mean
66631|NCT01143051|Secondary|Laboratory Analysis|Lab tests, including CBC, serum comprehensive metabolic panel, and urinalysis for all subjects, and urinary pregnancy test for women of child-bearing potential.|Screening, after each treatment and end of study, within 7 days of study visit 3||||||
66632|NCT01143051|Secondary|General Health Assessment|Physical examinations to assess general health|Screening and at or within 7 days after study visit 3||||||
66633|NCT01143051|Secondary|Hand Tremor|Hand tremor scores|at baseline, and at 10, 60, and 360 post-dose||||||
66634|NCT01143051|Secondary|Blood Values|Serum glucose and potassium levels;|at baseline, and at 15, 30, 60, 120, and 360 min post-dose||||||
66635|NCT01143051|Secondary|Telemetry and 12 Lead ECG Analysis|"Telemetry ECG recording of heart rate pre-dose, and during the initial 5 min post-dose.~A 12-lead ECG (Routine and QT / QTc intervals)at specified intervals"|within 30 min pre-dose, telemetry for 5 min post dose, 12 lead at 30, 90, and 360 min post-dose.||||||
66636|NCT01143051|Secondary|Vital Sign Analysis|Vital signs, i.e., blood pressure (SBP/DBP) and heart rate (HR);|at baseline, and at 10, 30, 60, 120, 180, and 360 min post-dose.||||||
67743|NCT01130597|Secondary|Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day||56 Days|||percentage of participants|||Number
66637|NCT01143051|Primary|Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.||pg/mL||Standard Deviation|Mean
66638|NCT01143038|Secondary|Number of Participants Who Developed Antibodies to Romiplostim|The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.|Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)|Safety analysis set participants with available results||participants|||Number
66639|NCT01143038|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.|From first dose date of romiplostim to end of study (up to 24 months).|Safety analysis set||participants|||Number
66640|NCT01143038|Secondary|Percentage of Participants With Splenectomy During the 12-month Treatment Period|If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.|12 months|Safety analysis set||percentage of participants||95% Confidence Interval|Number
66641|NCT01143038|Secondary|Percentage of Participants With ITP Remission|ITP remission was defined as maintaining every platelet count ≥ 50 x 10^9/L for at least 6 months in the absence of romiplostim and any other therapies to treat ITP.|Up to 24 months|Safety analysis set||percentage of participants||95% Confidence Interval|Number
66642|NCT01143038|Primary|Number of Months With Platelet Response During the 12-Month Treatment Period|The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.|12 months|Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.||months||Standard Error|Mean
66643|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|12 months|14 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 15 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
66644|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|6 months|12 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 11 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
66645|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|Baseline|4 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 2 out of the 86 participants in the Education Control group with diabetes at baseline had missing data due to not having HBA1C collected at baseline.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
66646|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|12 months|39 out of the 215 participants in the Pharmacist CVD group and 31 out of the 213 in the Education Control group had missing body mass index at 12 months due to missing the 12 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 12 month interview.||kg/m^2||Standard Deviation|Mean
66647|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|6 months|30 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing body mass index at 6 months due to missing the 6 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 6 month interview.||kg/m^2||Standard Deviation|Mean
66648|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 1 out of the 213 participants in the Education Control group had missing data due weight and/or height not collected at baseline.||kg/m^2||Standard Deviation|Mean
66649|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|12 months|34 out of the 215 participants in the Pharmacist CVD group and 27 out of the 213 in the Education Control group had missing cholesterol LDL at 12 months due to missing the 12 month interview entirely or not completing the lab assessment.||mg/dL||Standard Deviation|Mean
66650|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|6 months|29 out of the 215 participants in the Pharmacist CVD group and 22 out of the 213 in the Education Control group had missing cholesterol LDL at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.||mg/dL||Standard Deviation|Mean
66651|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|Baseline|4 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data due to not having cholesterol LDL collected at baseline.||mg/dL||Standard Deviation|Mean
67744|NCT01130597|Secondary|Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)||56 Days|||percentage of participants|||Number
66652|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|12 months|35 out of the 215 participants in the Pharmacist CVD group and 24 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 12 month assessment or non-response of adherence items collected in the 12 month interview.||participants|||Number
66653|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|6 months|28 out of the 215 participants in the Pharmacist CVD group and 18 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 6 month assessment or non-response of adherence items collected in the 6 month interview.||participants|||Number
66654|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to non-response of adherence items collected in the baseline interview.||participants|||Number
66655|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|12 months|43 out of the 215 participants in the Pharmacist CVD group and 33 of the 213 participants in the Education Control group had missing data at 12 months due to entirely missing the 12 month assessment or having missing data on one or more of the Framingham components.||% 10 yr Risk||Standard Deviation|Mean
66656|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|6 months|29 out of the 215 participants in the Pharmacist CVD group and 24 of the 213 participants in the Education Control group had missing data at 6 months due to entirely missing the 6 month assessment or having missing data on one or more of the Framingham components.||% 10 yr Risk||Standard Deviation|Mean
66657|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 months due to missing the 12 month interview entirely or blood pressure not collected at the 12 mo. assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
66658|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
66659|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.||mmHg||Standard Deviation|Mean
66660|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 mo. due to missing the 12 month interview entirely or blood pressure not collected at the 12 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
66661|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.||mmHg||Standard Deviation|Mean
66662|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.||mmHg||Standard Deviation|Mean
66663|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|Baseline|Two out of the 215 participants in the Pharmacist CVD group had missing data due to not having the blood pressure component of the Framingham collected at baseline.||% 10 yr Risk||Standard Deviation|Mean
66725|NCT01142193|Secondary|Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.||Percentage of participants|||Number
66664|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Re-exposure Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Start of re-exposure period to 56 days post last dose, up to Month 30|All treated participants entering the Re-exposure Period and having measurements available were analyzed. n=evaluable. Treatment groups represent Treatment received during Treatment Period.||participants|||Number
66665|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Withdrawal Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase (GGT) (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of study drug in the Treatment Period, entered the Withdrawal Period, and had values available. n=number evaluable||participants|||Number
66666|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Re-exposure Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.|First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days|Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.||participants|||Number
66667|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Withdrawal Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes events with an onset date on or after 57 days post last dosing day (active abatacept or active MTX whichever is the later) in the Treatment Period and up to end of Withdrawal Period. Treatment groups represent treatment received during the Treatment Period.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period and entered the Withdrawal Period. Treatment groups represent treatment during the TP.||participants|||Number
66668|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) and Discontinuations Due to AEs During the Full Study (All Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Includes data up to last active dose date +56 days if the participant discontinued the Treatment Period or did not enter the Withdrawal Period, up to the day of discontinuation in the Withdrawal Period for participants discontinuing the Withdrawal Period without entering the Re-exposure Period (RP), up to Day 729 visit (Month 24) for participants who complete the Withdrawal Period, and up to 56 days post last active dose in Re-exposure Period for participants entering the Re-exposure Period.|Day 1 to 56 days post last dose in the study, up to Month 30|All randomized participants who received at least 1 dose of study medication were analyzed.||participants|||Number
66669|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) Over Time in Treatment Period and Withdrawal Period|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity. Percent=number with remission/number evaluated (ITT)|Randomization to Month 24|ITT analysis population: Included all randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Participants were grouped according to the treatment regimen to which they were randomized.N= number evaluated.||percentage of participants||95% Confidence Interval|Number
66670|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time During Withdrawal Period- Treated Participants in Remission at Month 12|WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.). Percentage= number of participants with remission divided by number of participants who were analyzed (all treated participants who were in remission at end of treatment period and entered the Withdrawal Period)|End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)|Treated participants who were in remission at Month 12 (DAS28-CRP<2.6) and entered the Withdrawal Period were analyzed.( N=number of participants analyzed).||percentage of participants||95% Confidence Interval|Number
66671|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality During Treatment Period|Lower limit of normal (LLN); Upper limit of normal (ULN); Pretreatment (preRX). Criteria for marked abnormality: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Participants|||Number
66672|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. AEs of special interest are events potentially associated with the drug or disease under study.|Day 1 to 56 days following last dosing day (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period||Participants|||Number
66673|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period||Participants|||Number
66674|NCT01142726|Secondary|Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)|TP=treatment period; WP=withdrawal period. Change from Baseline=Postbaseline-baseline value. MRI was used to assess joint damage progression at Months 6, 12, and 18. If >20% of joints with a missing score for a parameter (erosion, osteitis, and synovitis), the MRI score of each parameter was considered missing. If ≤20% of joints had a missing score for a parameter, the MRI score for that parameter from the missing joints was carried forward from the previous MRI assessment, or carried backward from the next MRI assessment, if missing score occurred at baseline. MRI total score ranged from 0 (best outcome) to 4 (worst outcome). A gadolinium-enhanced MRI of the dominant hand-wrist was performed on all randomized patients at 5 points. The hand/wrist assessed to have more synovitis was selected initially and used for all subsequent evaluations. The MRI examination was standardized to ensure sufficient image quality for the evaluation of radiographic progression of rheumatoid arthritis.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=the number of patients with both baseline and postbaseline measurements.||Units on a scale||Standard Error|Mean
66675|NCT01142726|Secondary|Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores of Short Form-36 (SF-36)|TP=treatment period; WP=withdrawal period. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|Randomization to Months 6, 12, and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Units on a scale||Standard Error|Mean
66726|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.||Percent Reduction||Full Range|Median
67745|NCT01130597|Secondary|Mean Change From Baseline in Serum Potassium to End of Treatment||56 Days|||mEq/L||Standard Deviation|Mean
67746|NCT01130597|Secondary|Mean Patiromer Dose at Week 8||Up to Week 8|||grams||Standard Deviation|Mean
66676|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Over Time|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Units on a scale||Standard Error|Mean
66677|NCT01142726|Secondary|Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time|HAQ response defined as a reduction of at least 0.3 units from baseline in score on the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis.||Percentage of participants||95% Confidence Interval|Number
66678|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time|TP=treatment period; WP=withdrawal period. The SDAI is the simple linear sum of 5 outcome parameters: swollen joint count (SJC) and tender joint count (TJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SJC is assessed and recorded at each visit, with no swelling=0, swelling=1 (higher score indicates greater swelling). TJC is assessed at each visit through identification of joints that are painful under pressure or to passive motion, with no tenderness=0, tenderness=1 (higher score indicates greater affection due to disease activity)..|Randomization to Month 18|Intent to Treat (ITT) population. n= number of participants with both post baseline and baseline measurements.||Units on a scale||Standard Error|Mean
66679|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Months 12 and 18, and b=number of patients in the analysis.||Percentage of participants||95% Confidence Interval|Number
66680|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18|TP=treatment period; WP=withdrawal period. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Baseline to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable||Units on a scale||Standard Error|Mean
66681|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time - Intent to Treat Population|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis (intent to treat).||Percentage of participants||95% Confidence Interval|Number
66727|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.||Percentage of participants|||Number
66682|NCT01142726|Secondary|Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind monotherapy in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable||Percentage of participants||95% Confidence Interval|Number
66683|NCT01142726|Primary|Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|DAS28-CRP remission defined as <2.6; TP=treatment phase; WP=withdrawal phase. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable||Percentage of participants|||Number
66684|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months|||participants|||Number
66685|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months|||participants|||Number
66686|NCT01142596|Primary|Median Time to Loss of Effect in Non-Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Non-Responders, participants without ≥30% decrease from study P06124 baseline in PANSS Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant’s schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Non-Responders||days||95% Confidence Interval|Median
66687|NCT01142596|Primary|Median Time to Loss of Effect in Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Responders, participants with ≥30% decrease from study P06124 baseline in Positive and Negative Syndrome Scale (PANSS, schizophrenia symptom scale) Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant’s schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Responders||days||95% Confidence Interval|Median
66688|NCT01142596|Primary|Number of Participants Who Took Antiparkinsonian Drugs|This measure presents the number of participants who used antiparkinsonian drugs started on or after the start of study treatment in extension study P06125. Antiparkinsonian drugs were defined as those categorized into the N04 code (antiparkinson drugs) of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system.|P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
66689|NCT01142596|Primary|Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52|The percentage of participants with abnormal ECG findings is reported for three time points: 6-week double-blind study P06124 baseline, extension study P06125 baseline and extension study Week 52.|Study P06124 baseline and P06125 study baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug||percentage of participants|||Number
66728|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percentage of participants|||Number
66729|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percentage of participants|||Number
66690|NCT01142596|Primary|Number of Participants With Non-serious AEs|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. This measure presents the number of participants with at least one AEs that was non-serious (i.e., was not determined to be an SAE).|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
66691|NCT01142596|Primary|Number of Participants With Serious Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. A serious AE (SAE) is any AE occurring at any dose that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In addition, an important medical event that may not result in death, be life-threatening, or require hospitalization may be considered an SAE when it may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
66692|NCT01142596|Primary|Change From Study P06125 Baseline in Prolactin at Week 52|For each participant, change in prolactin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||μg/L||Standard Deviation|Mean
66693|NCT01142596|Primary|Change From Study P06124 Baseline in Prolactin at Week 52|For each participant, change in prolactin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||μg/L||Standard Deviation|Mean
66694|NCT01142596|Primary|Change From Study P06125 Baseline in Insulin at Week 52|For each participant, change in insulin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||μIU/mL||Standard Deviation|Mean
66695|NCT01142596|Primary|Change From Study P06124 Baseline in Insulin at Week 52|For each participant, change in insulin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||μIU/mL||Standard Deviation|Mean
66696|NCT01142596|Primary|Change From Study P06125 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||mmol/L||Standard Deviation|Mean
66697|NCT01142596|Primary|Change From Study P06124 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||mmol/L||Standard Deviation|Mean
66698|NCT01142596|Primary|Change From Study P06125 Baseline in HbA1c at Week 52|For each participant, change in HbA1c from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||percentage of HbA1c||Standard Deviation|Mean
66699|NCT01142596|Primary|Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|For each participant, change in HbA1c from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||percentage of HbA1c||Standard Deviation|Mean
66700|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment||score on a scale||Standard Deviation|Mean
66730|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percent Reduction||Full Range|Median
67747|NCT01130597|Secondary|Mean Patiromer Dose at Week 4||Up to Week 4|||grams||Standard Deviation|Mean
66701|NCT01142596|Primary|Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment||score on a scale||Standard Deviation|Mean
66702|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint|Change in DIEPSS Total Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment||score on a scale||Standard Deviation|Mean
66703|NCT01142596|Primary|Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint|Change in DIEPSS Total Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment||score on a scale||Standard Deviation|Mean
66704|NCT01142596|Primary|Number of Participants With Extrapyramidal Symptoms|This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for “extrapyramidal syndrome” were treated as extrapyramidal symptoms.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug||participants|||Number
66705|NCT01142596|Primary|Change From Study P06125 Baseline in BMI at Week 52|For each participant, change in BMI from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52||kg/m^2||Standard Deviation|Mean
66706|NCT01142596|Primary|Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52|For each participant, change in BMI from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52||kg/m^2||Standard Deviation|Mean
66707|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment|For each participant, change in weight from extension study P06125 baseline to the final assessment of extension study was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and final assessment||percentage of participants in category|||Number
66708|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment|For each participant, change in weight from preceding 6-week double-blind Study P06124 baseline to the final assessment of extension study P06125 was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 final assessment||percentage of participants in category|||Number
66731|NCT01142193|Secondary|Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percent Reduction||Full Range|Median
67748|NCT01130597|Secondary|Mean Patiromer Dose at Week 1||Up to Week 1|||grams||Standard Deviation|Mean
66709|NCT01142466|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline to Week 96|Safety population included all participants all randomized participants of the active treatment group who received at least 1 injection and all randomized participants of the ‘No Treatment’ group, provided that any post-baseline data was available.||participants|||Number
66710|NCT01142466|Secondary|Mean Changes in Expanded Disability Status Scale (EDSS) Score From Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5.|Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Units on a Scale||Standard Deviation|Mean
66711|NCT01142466|Secondary|Absolute Changes in the Number of T2 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T2 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||T2 lesions||Standard Deviation|Mean
66712|NCT01142466|Secondary|Absolute Changes in the Number of T1-Gadolinium (T1-Gd) Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1-Gadolinium enhancing lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|The data was not evaluated due to the small sample size available for this parameter.|||||
66713|NCT01142466|Secondary|Absolute Changes in the Number of T1 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||T1 lesions||Standard Deviation|Mean
66714|NCT01142466|Secondary|Number of Relapse-free Participants|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment.||participants|||Number
66715|NCT01142466|Primary|Time From Baseline to First Multiple Sclerosis Relapse (in Weeks)|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|Intent-to-treat (ITT) population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. Time to relapse was documented for participants who had at least 1 relapse during the study period.||weeks||Standard Deviation|Mean
66716|NCT01142388|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years|Eligible patients||percentage of participants||90% Confidence Interval|Number
66717|NCT01142388|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood’s formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients||months||90% Confidence Interval|Median
66718|NCT01142388|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (4 months) following the date last known progression-free, in which case the death was counted as an event, or in the case of death within 4 months of randomization in the absence of disease evaluation before that time. PFS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood’s formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients.||months||90% Confidence Interval|Median
66719|NCT01142323|Secondary|Interleukin 6|Interleukin 6 will be measured at entry and end of study as an indirect measure of PPAR alpha pathway activation.|6 months||||||
66720|NCT01142323|Secondary|Interleukin 1|Interleukin 1 will be measured at entry and end of study as an indirect measure of peroxisome proliferator- activated receptor alpha (PPAR- alpha) pathway activation.|6 months||||||
66721|NCT01142323|Secondary|Mayo Risk Score for Primary Sclerosing Cholangitis|The Mayo risk score, which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study|6 months||||||
66722|NCT01142323|Primary|Serum Alkaline Phosphatase|Serum alkaline phosphatase will be measured at entry and end of study|6 months|||U/L||Standard Error|Median
66723|NCT01142297|Secondary|Clinical Success of Implants||1 year||||||
67749|NCT01130597|Secondary|Mean Number of Patiromer Titrations||56 Days|||patiromer titrations||Standard Deviation|Mean
66733|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percentage of participants|||Number
66734|NCT01142193|Primary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug||Percent Reduction||Full Range|Median
66735|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
66736|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
66737|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Placebo to Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
66738|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Nexium Alone.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.|||||
66739|NCT01142115|Secondary|Haematuria|"Negative or positive result on a multistix urin analysis.~Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter."|2 hours after catheterisation at visits 1 and 2|ITT||participants|||Number
66740|NCT01142115|Secondary|Visible Blood|"Visual blood observed on the catheter or in the urine in connection to catheterization.~The nurse who conducted the catheterization could answer yes or no as follows:~Yes = visible blood observed. No = no visible blood observed."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||participants|||Number
66741|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Withdrawal Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been.~There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||participants|||Number
66742|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Insertion Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been.~There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||participants|||Number
66743|NCT01142115|Secondary|Irritation During Voiding After Catheterization|"After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no.~Yes - they experienced irritation. No - they did not experience irritation."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT||Participants|||Number
66744|NCT01142115|Primary|Discomfort Measured on the Visual Analog Scale (VAS)|"Outcome measured on a 10 cm Visual Analog Scale ranging from no discomfort (0cm) to worst thinkable discomfort (10cm)."|10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1|Intention to Treat (ITT) population||cm||Standard Deviation|Mean
66745|NCT01141660|Secondary|Anesthetic and Recovery Times||2 years||||||
66746|NCT01141660|Primary|Number of Participants With Laryngospasm||2 years|||Participants|||Number
66747|NCT01141595|Primary|Preschool Language Scales|Change in the raw score from baseline of the Preschool Language Scales over the 16 week period. The raw score was measured at baseline, 8 weeks and 16 weeks after starting treatment and the change over the 16 week period from baseline to the end of the study was calculated. There was no imputed data and the analysis was as treated. The raw score ranged from 0 to 130. Higher scores indicate better performance.|16 weeks|The number of participants with data available that completed at least the 16 week assessment.||Raw score units / 16 weeks||Standard Deviation|Mean
66748|NCT01141491|Secondary|Overall Survival|To compare the overall survival over time, to estimate the median and 3-year progression-free survival.|Measured over time||04/2017||||
66749|NCT01141491|Primary|Progression Free Survival|"The primary objective is to compare the progression-free survival (PFS) over time.~Progression free survival is defined as the time from randomization until any evidence of tumor growth or appearance anywhere in the body or death from any cause as determined by the principal investigator at each site. The principal investigator will determine Progression-free survival by using CT scans to evaluate disease recurrence. For the purpose of this study, progression of disease is defined as the development of tumor growth or recurrence at any site of the body as determined by the principal investigator at each study site or death from disease"|3-years|||Days||95% Confidence Interval|Median
66750|NCT01141374|Secondary|Stress Levels(3rd and 4th Evaluation)|Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 and 75 days|75 participants were assessed||units on a scale||Standard Deviation|Mean
66751|NCT01141374|Primary|Stress Levels After 4 Sessions (2nd Evaluation)|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 30 days|Of the 109 subjects, four were eliminated for having a low level of stress and 3 for not belonging to nursing staff. Of the 105, 7 didn't appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one did not complete the questionnaire, seven went on vacation or sick leave (2).||units on a scale||Standard Deviation|Mean
66752|NCT01141283|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|6 months.|The extension safety population consisted of all subjects who were exposed to BTDS and had at least 1 safety assessment during extension phase.||participants|||Number
67750|NCT01130597|Secondary|Median Time to First Patiromer Dose Titration||56 Days|||days||95% Confidence Interval|Median
66753|NCT01141205|Secondary|Increase in Blood CD4 T-cell Counts|Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of >100 CD4 Tcell per microliter|up to 6 months post vaccination|Participants minus drop-outs and withdrawn participants||participants with increased CD4 count|||Number
66754|NCT01141205|Secondary|Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log|changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log|up to 6 months post immunization|Participants minus drop outs and participants withdrawn by them selves or by the physicians||participants with lowering of VL|||Number
66755|NCT01141205|Secondary|Induction of New T-cell Immune Response by the Vaccine|induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (> 50 sfu/mio PBMC).|up to 6 months after last immunisation|Analyzed: Participants minus drop-outs and withdrawn participants. Reported: numbers of participants with a new induced ELISPOT Y-cell immune response to the vaccine peptide epitopes||ELISPOT responders|||Number
66756|NCT01141205|Primary|Tolerability and Safety of the Treatment.|"We report here the numbers of participants with vaccine related adverse events degree 3 or 4.~Our goal for safety and tolerability was: Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4."|up to 6 months after end of treatment|Analyzed: number of participants started minus individuals lost to follow up or participants that withdraw. Thus we include the two individuals where the physician stopped his/her participation because of SAE not related to the vaccine or to the placebo. Reported: numbers of participants with vaccina related SAE||participants|||Number
66757|NCT01140906|Secondary|Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine|The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms.|Change from Week 8 in DESS total score analyzed at Week 10|All Patients Completed Set (APCS), OC, Analysis of Covariance (ANCOVA)||units on a scale||Standard Error|Mean
66758|NCT01140906|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient’s recent sexual experience. Patients are asked to assess their own experience over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.|Baseline and Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
66759|NCT01140906|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
66760|NCT01140906|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF, Logistic Regression||percentage of patients|||Number
66761|NCT01140906|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20||Baseline and Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
66762|NCT01140906|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS, MMRM||units on a scale||Standard Error|Mean
66763|NCT01140906|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS, last observation carried forward (LOCF), Logistic Regression||percentage of patients|||Number
66764|NCT01140906|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS), mixed model for repeated measurements (MMRM)||units on a scale||Standard Error|Mean
66765|NCT01140880|Primary|Course Completion|PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion.|28-days post initiation|40 participants initiated PEP during the study, of which 30 had evaluable course completion data.||participants|||Number
66766|NCT01140880|Primary|Medication Adherence|Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.|Daily throughout medication course|40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).||proportion|||Number
66767|NCT01140880|Secondary|Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)|Abstinence will be measured using thrice weekly urine drug screens and self-report|Thrice-weekly for 8 weeks|170 participants enrolled in the study, of which 30 were involved in a protocol violation that rendered their data un-analyzable. The final analytical sample is N = 140.||Stimulant-free urinalyses||Standard Deviation|Mean
66768|NCT01140880|Primary|Time From Exposure to Truvada Initiation|Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.|6-month follow-up|40 participants with evaluable data initiated Truvada during the course of the study.||hours||Standard Deviation|Mean
66769|NCT01140867|Secondary|QoL-QOLIE31 (Quality of Life in Epilepsy)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included.||Units on a Scale||Standard Deviation|Mean
66770|NCT01140867|Secondary|Responder Rate|The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.||Percentage of Participants|||Number
66771|NCT01140867|Secondary|Seizure Free Rate|The percentage of the participants who experienced no seizure during the trial.|16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.||Percentage of Participants|||Number
66772|NCT01140867|Primary|Seizure Reduction Rate|The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.||Percentage of Seizure Reduction Rate||Standard Deviation|Mean
66773|NCT01140815|Secondary|2-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|2 years|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
66774|NCT01140815|Secondary|1-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|1 year|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
66775|NCT01140815|Secondary|4-month Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|4 months|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
66776|NCT01140815|Secondary|6-week Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|6 weeks|Patients who were not revised and were able to make an appointment and complete the testing did so.||seconds||Standard Deviation|Mean
66777|NCT01140815|Secondary|2-year Patient Surveys|Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).|2 years|Patients who were not revised within 2 years and were able to complete a questionnaire did so.||units on a scale 0-48||Full Range|Mean
66778|NCT01140815|Secondary|2-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported.|2 years|||participants|||Number
66779|NCT01140815|Secondary|1-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported.|1 year|||participants|||Number
66780|NCT01140815|Secondary|4-month X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported.|4 months|||participants|||Number
66781|NCT01140815|Secondary|6-Week X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.|6 weeks|||participants|||Number
66782|NCT01140815|Primary|1-year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|1 year|||units on a scale 0-100||Standard Deviation|Mean
66783|NCT01140815|Primary|4-Month Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|4 months|||units on a scale 0-100||Standard Deviation|Mean
66784|NCT01140815|Primary|6-Week Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|6 weeks|||units on a scale 0-100||Standard Deviation|Mean
66785|NCT01140815|Primary|2-Year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|2 years|||units on a scale 0-100||Standard Deviation|Mean
66788|NCT01140646|Primary|Percent of Baseline in Average Hot Flash Activity (Score and Frequency)|Hot flash score was defined as the number of mild hot flashes for the week plus two times the number of moderate hot flashes plus three times the number of severe hot flashes plus four times the number of very severe hot flashes. Hot flash frequency was defined as the average number of hot flashes per day for each week. Week 7 percent of baseline was calculated. The reduction in hot flash score and frequency can be calculated by subtracting the week 7 percent of baseline from 100 percent.|From baseline to week 7|Analysis population includes only the subjects who have completed the quality of life self-assessment questionnaire.||Percent of baseline||95% Confidence Interval|Mean
66789|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy as Measured by the Mean Change in CDASI-activity at 12 Weeks|The CDASI (Cutaneous Dermatomyositis Activity and Severity Index) is a validated instrument to measure skin disease activity in dermatomyositis. A clinically meaningful change is a decrease of 4 points. All missing data are imputed using last observation carried forward. Calculation is performed as the score at 12 weeks minus the score at baseline.|Data collected at baseline at 12 weeks|||units on a scale||Standard Deviation|Mean
66790|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy, as Measured by the Number of Participants Experiencing a 30% Decreased in the CDASI-a Score at 12 Weeks.|This was an intent to treat analysis--dropouts are considered treatment failures. Missing data at 12 weeks imputed by last observation carried forward.|Data collected at 12 weeks after baseline visit.|||participants|||Number
66791|NCT01140503|Primary|The Primary Endpoint Analysis Will be Safety, as Measured by the Number of Adverse Events and Serious Adverse Events Occuring During 12 Weeks of Therapy and 4 Weeks of Followup.||16 weeks|||adverse events|||Number
66792|NCT01140477|Secondary|Visual Acuity|Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.||logMAR||Standard Deviation|Mean
66793|NCT01140477|Secondary|Lens Misalignment|This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.||degrees||Standard Deviation|Mean
66794|NCT01140477|Primary|Percent Reduction in Absolute Cylinder|Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.|120 – 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.||percentage of intended cylinder reduct||95% Confidence Interval|Mean
66795|NCT01140347|Secondary|Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]|Participants were considered positive for anti-ramucirumab antibodies [anti-drug antibodies (ADA)] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.|Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)|Participants who received at least 1 dose of study drug and had post-treatment ADA analysis.||participants|||Number
66796|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 7||1 hour following completion of Cycle 7 (14-day cycles) infusion|Participants who received Cycle 7 of Ram and had Cmax results.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
66797|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 4||1 hour following completion of Cycle 4 (14-day cycles) infusion|Participants who received Cycle 4 of Ram and had Cmax results.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
66798|NCT01140347|Secondary|Maximum Concentration (Cmax) of Ramucirumab, Cycle 1||1 hour following the completion of Cycle 1 (14-day cycle) infusion|Participants who received Cycle 1 of Ram and had Cmax results.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
66799|NCT01140347|Secondary|Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died|The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 37 months)|Participants who received at least 1 dose of study drug.||participants|||Number
66800|NCT01140347|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score|The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)|Randomized participants who had an EQ-5D score at baseline and the specified time points.||units on a scale||Standard Deviation|Mean
66801|NCT01140347|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)|The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)|Randomized participants who had FHSI-8 at baseline and the specified time points.||units on a scale||Standard Deviation|Mean
66858|NCT01139515|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Full Range|Geometric Mean
66802|NCT01140347|Secondary|Time to Radiographic Progression (TTP)|TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=86, Pl=52.||months||95% Confidence Interval|Median
66803|NCT01140347|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to <10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) * 100.|Baseline to the date of first evidence of confirmed CR or PR (up to 37 months)|ITT Population: All randomized participants.||percentage of participants||95% Confidence Interval|Number
66804|NCT01140347|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=43, Pl=19.||months||95% Confidence Interval|Median
66805|NCT01140347|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death from any cause (up to 37 months)|Intent-to-treat (ITT) Population: All randomized participants. Participants censored: Ramucirumab+BSC (Ram)=65, Placebo+BSC (Pl)=58.||months||95% Confidence Interval|Median
66806|NCT01140295|Secondary|Proportion of Patients With Abnormal Electrolyte Levels|"The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna.~Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant."|The outcome measure will be assessed once one day after the completion of colonoscopy preparation|||Proportion of patients|||Number
66807|NCT01140295|Primary|Efficacy of Colon Preparation|Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.|The outcome measure will be assessed once one day after the completion of colonoscopy preparation|||percentage of patients|||Number
66808|NCT01140061|Primary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 28|The population consisted of all enrolled participants who received at least one dose of study medication.||Participants|||Number
66809|NCT01140061|Primary|Number of Participants With an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 14 days after last dose of study drug (up to Day 42)|The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.||Participants|||Number
66810|NCT01140061|Primary|Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days|Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis|Day 11|The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.||nM||Standard Deviation|Mean
67751|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Downtitration||56 Days|||percentage of participants|||Number
66811|NCT01140061|Primary|Number of Participants With an Adverse Event of Erythema in Part I of the Study|Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 22 in Part 1|The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.||Participants|||Number
66812|NCT01140048|Secondary|Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor|"Use of Chronic Asthma Therapy for the period of 12 months prior to the age of 6 years was defined by clinical review of reported concomitant medications.~Prognostic factors for use of chronic asthma therapy at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available.||percentage of participants|||Number
66813|NCT01140048|Secondary|Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor|"Atopic disorders include allergic rhinitis (AR) and/or atopic dermatitis (AD). Atopic disorders was defined as a positive response to the Epidemiology Questionnaire item In the past 6/12 months, has your child had a problem with sneezing or runny or blocked nose when he/she did not have a cold or the flu? for AR and/or a positive response to both of the following items for AD: Has your child had an itchy rash which was coming and going at any time in the past 6/12 months? and Has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears, or eyes? for the period of 12 months prior to age 6 years.~Prognostic factors for atopic disorders at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.||percentage of participants|||Number
66814|NCT01140048|Primary|Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor|"Asthma was defined as a positive response to the Epidemiology Questionnaire item Has your child had wheezing or whistling in the chest in the past 6/12 months? for the period of 12 months prior to age 6 years.~Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.||percentage of participants|||Number
66815|NCT01139879|Secondary|Healing Rate Per Week|The mean change in area per week for all ulcers|12 weeks|Rate of change in area (healing) for all ulcers on all subjects in area (cm^2)/week||cm^2/week|Participants|Standard Deviation|Mean
66816|NCT01139879|Secondary|Incidence of New Ulcers|incidence of new ulcers while on the study surface|12 Weeks|||percentage of participants|||Number
66817|NCT01139879|Primary|Change From Baseline in Ulcer Surface Area at Week 12|The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.|12 Weeks|Ulcers decreased an average of 7.96 cm^2 (+/- 8.1 cm^2) over the 12 week period||cm^2|Participants|Standard Deviation|Mean
66818|NCT01139814|Primary|Evaluation of Major Complications|Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.|Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.|||Participants||95% Confidence Interval|Number
66819|NCT01139814|Primary|Navigation Performance|Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.|During Procedure|||Successful locations|Participants|95% Confidence Interval|Number
66820|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF Questions 3 and 4 measurement.||units on a scale||Standard Error|Least Squares Mean
66821|NCT01139762|Secondary|Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks|Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.|Baseline, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline PVR measurement.||milliliters (mL)||Standard Deviation|Mean
66822|NCT01139762|Secondary|Clinician Global Impression of Improvement (CGI-I) at 26 Weeks|Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had CGI-I measurement at 26 weeks endpoint.||participants|||Number
66859|NCT01139515|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Full Range|Geometric Mean
66823|NCT01139762|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.|26 weeks|All randomized participants who received at least 1 dose of the study drug and had TSS-BPH measurement at 26 weeks endpoint.||units on a scale||Standard Deviation|Mean
66824|NCT01139762|Secondary|Patient Global Impression of Improvement (PGI-I) at 26 Weeks|Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.||participants|||Number
66825|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks|Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.||units on a scale||Standard Error|Least Squares Mean
66826|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.||units on a scale||Standard Error|Least Squares Mean
66827|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.||units on a scale||Standard Error|Least Squares Mean
66828|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.||units on a scale||Standard Error|Least Squares Mean
66829|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.||units on a scale||Standard Error|Least Squares Mean
66830|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks|"IPSS Quality of Life Index assesses participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction."|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.||units on a scale||Standard Error|Least Squares Mean
66903|NCT01138826|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
66831|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.||units on a scale||Standard Error|Least Squares Mean
66832|NCT01139762|Secondary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
66833|NCT01139762|Primary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 12 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.||units on a scale||Standard Error|Least Squares Mean
66834|NCT01139658|Secondary|Reasons for Usual Follow-up||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66835|NCT01139658|Secondary|Reasons for Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.|||||
66836|NCT01139658|Secondary|Duration of Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.|||||
66837|NCT01139658|Secondary|Frequency of Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||times per week||Standard Deviation|Mean
66838|NCT01139658|Secondary|Reasons for Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66839|NCT01139658|Secondary|Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66840|NCT01139658|Secondary|Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66841|NCT01139658|Secondary|Number of Patients Who Switched to Another Anticoagulant Therapy|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|11 weeks|||participants|||Number
66842|NCT01139658|Secondary|Concomitant Treatments|Concomitant treatments prescribed at hospital discharge.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66843|NCT01139658|Secondary|Adherence to Treatment|The adherence to treatment was measured by patient declaration.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||percent||Standard Deviation|Mean
66844|NCT01139658|Secondary|Proportion of Patients With a Preoperative ALT Measurement||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||percentage of participants|||Number
66845|NCT01139658|Secondary|Duration of Treatment||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||days||Standard Deviation|Mean
66846|NCT01139658|Secondary|Duration Between Surgery and First Dose of Pradaxa||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||hours||Standard Deviation|Mean
66847|NCT01139658|Secondary|Dosage of Pradaxa at Initiation||Baseline|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66860|NCT01139515|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng* hr/mL||Full Range|Geometric Mean
66848|NCT01139658|Primary|Occurrence of Major Bleeding Events|"Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.~a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE)."|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66849|NCT01139658|Primary|Occurrence of Symptomatic Venous Thromboembolic Events|Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.||participants|||Number
66850|NCT01139580|Secondary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8|The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions.|Week 8|ITT Population. Data were analyzed using the failure and LOCF methods.||participants|||Number
66851|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8|Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges.|Baseline and Week 8|ITT Population||participants|||Number
66852|NCT01139580|Primary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points).||participants|||Number
66853|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates.|Baseline and Week 8|ITT Population||participants|||Number
66854|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8|Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration.|Baseline and Week 8|ITT Population||participants|||Number
66855|NCT01139580|Primary|Number of Participants With an Investigator’s Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1.||participants|||Number
66856|NCT01139515|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Hr||Standard Deviation|Mean
66857|NCT01139515|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||Hr||Full Range|Median
66861|NCT01139450|Secondary|The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)||Baseline, 4 weeks||||||
66865|NCT01139411|Secondary|Communication 2: Observed Parent-adolescent Communication Quality (DOCS)|Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations.||units on a scale||Standard Deviation|Mean
66866|NCT01139411|Secondary|Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)|Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only||units on a scale||Standard Deviation|Mean
66867|NCT01139411|Secondary|Parent Modeling 4: Weight and Body Concerns (FERF-Q)|Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only||units on a scale||Standard Deviation|Mean
66868|NCT01139411|Secondary|Parent Modeling 3: Physical Activity (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only||units on a scale||Standard Deviation|Mean
66869|NCT01139411|Secondary|Parent Modeling 2: Self-monitoring (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.||units on a scale||Standard Deviation|Mean
66870|NCT01139411|Secondary|Parent Modeling 1: Dietary Choices (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.||units on a scale||Standard Deviation|Mean
66871|NCT01139411|Primary|Body Mass Index|Post-treatment BMI (controlling for baseline BMI)|Baseline and at completion of 16 week intervention|||kilograms/meters squared||Standard Deviation|Mean
66872|NCT01139190|Primary|Degree of GI Injury at Day 15|"Degree of mucosal injury was assessed by endoscopy, with the following scoring system:~Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer"|15 days|Per Protocol Population: subset of participants who had an endoscopy performed at Day 15 reviewed by both blinded endoscopists, was at least 85% compliant with taking the study drug (based on pill counts), who took the final dose drug on the day of the second endoscopy, and who had no other protocol violations that would affect assessments.||participants|||Number
66873|NCT01139164|Secondary|Morbidity of Allogeneic Stem Cell Transplants|To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens. The average number of days spent in the hospital until day +100 will be reported as a surrogate for morbidity and complications.|100 days|This study terminated early; funding ran out before the analysis could be completed.|||||
66874|NCT01139164|Secondary|To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants|To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens. It will be measured as the proportion of subjects meeting criteria for engraftment before day +30 and full donor chimerism demonstrated before or at day +100. Engraftment is defined by maintenance of ANC > 500/mm3 for at least 3 consecutive days and platelet count > 20,000/mm3 for 3 consecutive days in absence of platelet transfusion. These criteria must have been met before Day +30. Chimerism is the pressence of donor cells and will be analyzed by FISH for sex-mismatched donor-recipient pairs and VNTR analysis for sex-mathced pairs. Chimerism by Day +100 will be documented for this outcome|Day +100|The outcome measure data below only accounts for the number of subjects who met the engraftment criteria prior at day +30; the chimerism data was not collected. For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.||participants|||Number
66875|NCT01139164|Primary|To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.|Number of subject deaths prior to day 100.|8 years|For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.||participants|||Number
66876|NCT01139125|Primary|Safety and Efficacy|We are measuring if this medication is appropriate for use in schizophrenia patients.|4 months||||||
66877|NCT01139047|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the subject preference survey at week 3|3 weeks|Safety||participants|||Number
67752|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Uptitration||56 Days|||percentage of participants|||Number
66878|NCT01139047|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|day 22|||participants|||Number
66879|NCT01139047|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety||participants|||Number
66880|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.|Up to 7 days after any vaccination|The analysis was done on safety subset.||Number of Subjects|||Number
66881|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability by reporting solicited local and systemic adverse events of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|Up to 7 days after any vaccination.|The analysis was done on safety subset.||Number of subjects|||Number
66882|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events in yerms of serious adverse events (SAEs), atleast possibly related SAEs and AEs leading to withdrawl of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.|The analysis was done on safety subset.||Number of Subjects|||Number
66883|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.|||Number of subjects|||Number
66884|NCT01139021|Secondary|GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.~Analysis was done on MITT population (Secondary)."|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).||Concentration IU/mL||95% Confidence Interval|Geometric Mean
66885|NCT01139021|Secondary|Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|"To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains.~Analysis was done on MITT population (Secondary)."|1 month post two catch-up doses versus prevaccination|Analysis was done on MITT population (Secondary).||Percentage of subjects||95% Confidence Interval|Number
66886|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary)||Percentage of subjects||95% Confidence Interval|Number
66887|NCT01139021|Secondary|GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).||Titers||95% Confidence Interval|Geometric Mean
66888|NCT01139021|Secondary|GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).||Concentration IU/mL||95% Confidence Interval|Geometric Mean
66889|NCT01139021|Secondary|Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.|To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age.Both the groups received MMRV at 12 months of age.|1 month post booster dose versus prebooster.|Analysis was done on MITT population (Secondary).||Percentage of Subjects||95% Confidence Interval|Number
66890|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|6month post booster dose and 12 months post two catch-up dose vaccination.|Analysis was done on MITT population (Secondary).||Percentage of subjects||95% Confidence Interval|Number
66891|NCT01139021|Secondary|GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).||Titers||95% Confidence Interval|Geometric Mean
66892|NCT01139021|Primary|Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953.~Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).||Concentration IU/mL||95% Confidence Interval|Geometric Mean
66893|NCT01139021|Primary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).~Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).||Percentage of subjects||95% Confidence Interval|Number
66894|NCT01139021|Primary|Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).~Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).||Titers||95% Confidence Interval|Geometric Mean
66895|NCT01139008|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the Subject Preference Survey at week 3|week 3|Safety||participants|||Number
66896|NCT01139008|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22.|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|Day 22|Safety||participants|||Number
66897|NCT01139008|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety||participants|||Number
66898|NCT01138995|Secondary|User Satisfaction|Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,|Week 30|All randomized subjects were analyzed.||units on a scale||Standard Deviation|Mean
66899|NCT01138995|Secondary|Berg Balance Scale (BBS) Score|Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.|Week 30|All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.||units on a scale||Standard Deviation|Mean
66900|NCT01138995|Primary|Ten Meter Walk Test (10mWT)|"Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard usual ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm."|Week 30|Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.||meters per second (m/s)||Standard Deviation|Mean
66901|NCT01138969|Secondary|Peptic Ulcer Bleeding|participants with peptic ulcer bleeding within 6 months|6 months|Intention to treat||participants|||Number
66902|NCT01138969|Primary|Recurrent Peptic Ulcer|Number of participants with recurrent peptic ulcer within 6 months|6 months|Intention to treat||participants|||Number
67753|NCT01130597|Secondary|Mean Dose of Patiromer at End of Treatment||56 Days|||grams||Standard Deviation|Mean
66904|NCT01138826|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
66905|NCT01138826|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Full Range|Geometric Mean
66906|NCT01138826|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
66907|NCT01138826|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr*ng/mL||Full Range|Geometric Mean
66908|NCT01138735|Secondary|Change in Inflammatory Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF||lesion count change||Standard Deviation|Mean
66909|NCT01138735|Secondary|Percent Change in Total Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF||percentage of change in lesion count||Standard Deviation|Mean
66910|NCT01138735|Primary|Change From Baseline in Total Lesion Counts||Baseline to Week 12 (LOCF)|ITT population, LOCF||lesion count change||Standard Deviation|Mean
66911|NCT01138735|Primary|Success Rate|Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)|Baseline to Week 12 (Last Observation Carried Forward [LOCF])|Intent to treat (ITT) population, LOCF||percentage of participant|||Number
66912|NCT01138657|Secondary|Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
66913|NCT01138657|Secondary|Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
66914|NCT01138657|Secondary|Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
66915|NCT01138657|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
66916|NCT01138657|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Central retinal thickness was measured using optical coherence tomography and assessed by a central reader.|Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||percent change||Standard Deviation|Mean
67754|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at the End of Treatment||56 Days|||percentage of participants|||Number
66917|NCT01138657|Secondary|Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline||months||Inter-Quartile Range|Median
66918|NCT01138657|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart.|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||logMAR||Standard Deviation|Mean
66919|NCT01138657|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured."|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
66920|NCT01138657|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell;~Grade 0.5+ = 1-5 cells;~Grade 1+ = 6-15 cells;~Grade 2+ = 16-25 cells;~Grade 3+ = 26-50 cells;~Grade 4+ = > 50 cells."|From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points (best state achieved prior to Week 6 and at least 1 post-week 6 value); last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.||units on a scale||Standard Deviation|Mean
66921|NCT01138657|Primary|Time to Treatment Failure on or After Week 6|"Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:~New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline~Inability to achieve ≤ 0.5+ at Week 6 or a 2-step increase relative to best state achieved at all visits after Week 6 in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 6 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.||months||Inter-Quartile Range|Median
66922|NCT01138514|Secondary|Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)|Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.|10 weeks|per-protocol population||participants|||Number
66923|NCT01138514|Primary|Percent Change From Baseline in Non-inflammatory Lesions||10 weeks|Per protocol population||percentage of lesion reduction||Standard Deviation|Mean
66924|NCT01138514|Primary|Percent Change From Baseline in Inflammatory Lesions||10 weeks|Per protocol population||percentage of lesion reduction||Standard Deviation|Mean
66925|NCT01138501|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.||events|||Number
66926|NCT01138501|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.|The safety analysis set includes all 63 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 59 subjects had 50 exposure days (EDs).||N with Inhibitors / N with ≥50 EDs|||Number
66927|NCT01138150|Secondary|Resistin|serum resistin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
66928|NCT01138150|Secondary|Leptin|serum leptin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment|||ug/mL||95% Confidence Interval|Mean
103168|NCT00789724|Secondary|Difference Between the 2 Arms in Change in Oxygen Uptake Kinetics From Baseline to Follow up Exam at Submaximal Cardiopulmonary Exercise Test||10-14 weeks||||||
66935|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile’s with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
66936|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
66937|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
66938|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
66939|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile’s with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
66940|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
67473|NCT01133665|Secondary|Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
66941|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
66942|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.||participants|||Number
66943|NCT01138111|Secondary|Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress|"Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive.~For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point.~Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point.~PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period.~NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period."|2 scanning periods post injection to be evaluated at baseline|All subjects with PET data at the referenced study time point||percentage of subjects|||Number
66944|NCT01138111|Secondary|Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress|At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader’s evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period.|2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months|All subjects with PET data at the referenced study time point||participants|||Number
66945|NCT01138111|Secondary|Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4|This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress.|1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months|All subjects receiving study drug||participants|||Number
66946|NCT01138111|Primary|Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake|Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)|1 scanning period post injection to be evaluated at baseline, 12 months and 24 months|All subjects receiving study drug with PET scan data at the respective timepoint||SUVR||Standard Deviation|Mean
66947|NCT01138098|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|After the challenge dose of Engerix™-B vaccine up to the study end|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
66948|NCT01138098|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix™-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
66949|NCT01138098|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal, headache and temperature (Temperature is defined as axillary temparature equal to or above 37.5 degrees Celsius (°C)).|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix™-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
66950|NCT01138098|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix™-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.||Subjects|||Number
66951|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before the challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
66952|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before and one month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
66953|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL|A seropositive subject was defined as a subject with anti-HBs antibody concentration ≥ the 6.2 mIU/mLcut-off. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
66954|NCT01138098|Secondary|Number of Subjects With an Anamnestic Response to a Challenge Dose|The anamnestic response was defined as: at least (≥) a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in seronegative subjects at the pre-challenge dose time point. A seropositive/seronegative subject is a subject with anti-HBs antibody concentration ≥/lower than (<) 6.2 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
66955|NCT01138098|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month after a challenge dose of Engerix™-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.||Subjects|||Number
66956|NCT01138046|Secondary|Drug Clearance (CL) of Paclitaxel|CL is defined as the volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. CL was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation.||mL/hour/m^2||95% Confidence Interval|Geometric Mean
66957|NCT01138046|Secondary|Half-life (t1/2) of Paclitaxel|Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half. T1/2 was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||Hr||95% Confidence Interval|Geometric Mean
66958|NCT01138046|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel|Vss is the volume of distribution at steady state of paclitaxel. Vss was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||milliliter per meters squared (mL/m^2)||95% Confidence Interval|Geometric Mean
67149|NCT01136408|Primary|Incidence and Severity of Adverse Events|Intensity of event is categorised as mild, moderate and severe.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||participants|||Number
66959|NCT01138046|Secondary|Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel|Tmax is defined as the time to peak concentration from initiation of lapatinib and paclitaxel dosing. Tmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||Hr||Full Range|Median
66960|NCT01138046|Secondary|AUC From Time Zero to Infinity (0-INF) of Paclitaxel|AUC(0-INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. AUC (0-INF) was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||hr*ng/mL||95% Confidence Interval|Geometric Mean
66961|NCT01138046|Secondary|Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel|AUC is defined as the area under the lapatinib or paclitaxel concentration-time curve from time 0 to 24 hours (hrs). AUC (0-24) was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation||hours * nanograms/milliliter (hr*ng/mL)||95% Confidence Interval|Geometric Mean
66962|NCT01138046|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel|Cmax is defined as the maximum concentration of lapatinib and paclitaxel. Cmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|Pharmacokinetic (PK) Population: all participants who provided blood samples for PK evaluation||Nanogram per milliliter ng/mL||95% Confidence Interval|Geometric Mean
66963|NCT01138046|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined using RECIST as the number of participants who received at least one dose of study medication and achieved a best OR classified as CR, PR or SD for at least 6 months (24 weeks), i.e., CR + PR + SD for >=24 weeks. CBR was based on confirmed responses by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. SD is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the the four preceding definitions was considered Not evaluable|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.||Participants|||Number
66964|NCT01138046|Secondary|Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)|Best OR was defined as the best response recorded from the start of treatment until progressive disease (PD)/death as assessed by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the four preceding definitions was considered Not evaluable.|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.||Participants|||Number
66965|NCT01138046|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of a CR or a PR until the first documented sign of disease progression or death due to any cause (whichever occured earlier). The analysis was based on responses as evaluated by the investigator and was confirmed at a repeat assessment, with the duration of response taken from the first time the response was observed. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 953 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed. For participants who did not progress or die, duration of response was censored on the date of the last assessment.||Months||95% Confidence Interval|Median
66966|NCT01138046|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until first documented evidence of partial response (PR) or a complete response (CR) (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the start of treatment until the first documented evidence of a PR or CR, whichever status is recorded first (up to 66 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed.||Months||95% Confidence Interval|Median
66984|NCT01137812|Secondary|Percentage of Patients With HbA1c <7% at Week 52|The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage.|Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
66967|NCT01138046|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the start of treatment and the earliest date of radiological disease progression or death due to any cause, whichever occurred first. PFS was based on the investigator's assessment. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until the earliest date of radiological disease progression or death due to any cause, whichever occured first (up to 1009 Days).|All Subjects Population. Participants who met the following criteria were censored: no Baseline assessment, no progression, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment started, and death or progression after more than one missed visit.||Months||95% Confidence Interval|Median
66968|NCT01138046|Primary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until death due to any cause or study close, whichever occurred first (assessed up to a maximum of 1290 Days)|All Subjects Population: all participants who received at least one dose of study medication||Months||95% Confidence Interval|Median
66969|NCT01138046|Primary|Number of Participants With Intolerable Toxicities in Phase I of the Study|Investigational treatment was considered tolerable if one or more of the tolerability criteria were met by none or one of the 6 participants in the first cycle of Phase I. If one or more tolerability criteria were met by two or more participants, the issue was referred to the safety committee. Tolerability criteria for toxicities related to investigational treatment included grade 4 neutropenia persisting for 7 or more days, thrombocytopenia with a platelet count of less than or equal to 25,000/millimeter (mm)^3 , clinically significant Grade 3 or 4 non-haematologic toxicities (excluding nausea) and inability to start cycle 2 within 2 weeks of scheduled dosing due to unresolved toxicity.|28 days|All Subjects Population: all participants who received at least one dose of study medication and participated in Phase I of the study.||Participants|||Number
66970|NCT01138007|Secondary|Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). Only five items (item 19: general interest; item 20: energy level; item 21: capacity for pleasure or enjoyment, excluding sex; item 22: interest in sex; item 30: leaden paralysis/physical energy) were evaluated for this endpoint, as a subset of the total score. The lowest possible total score and subset total score of IDS-SR are 0 and 0, and the highest possible total score and subset total score of IDS-SR are 84 and 15, respectively. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR subscore and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
66971|NCT01138007|Secondary|Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). The maximum total score is 84 (0: no symptoms; 84: greatest symptom severity), as participants were asked to answer either item 11 (decreased appetite) or item 12 (increased appetite) (not both) and either item 13 (decreased weight) or item 14 (increased weight) (not both). Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
66972|NCT01138007|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8|A CGI-SI assessment was performed in terms of severity in depression, by using scores from 0 to 7: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill participants. Change from Baseline in the CGI-SI score was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline CGI-SI score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
66973|NCT01138007|Secondary|Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8|A CGI-GI assessment was performed at Week 8 (or withdrawal) in comparison with severity in depression observed at Baseline (Week 0; no actual assessment was performed at Baseline [the comparison was subjective]), by using scores from 0 to 7: 0, Not assessed; 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse. A CGI-GI responder is defined as a participant with a CGI-GI score of very much improved or much improved at Week 8.|Week 8|FAS. Missing values were imputed using LOCF. Only those participants who were available at Week 8 were analyzed.||participants|||Number
66974|NCT01138007|Secondary|Number of MADRS Remitters at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS remitter is defined as a participant with a MADRS total score <=11 at Week 8.|Week 8|FAS. Missing values were imputed using LOCF.||participants|||Number
66975|NCT01138007|Secondary|Number of MADRS Responders at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS responder is defined as a participant with a >=50% reduction from Baseline in the MADRS total score at Week 8.|Baseline and Week 8|FAS. Missing values were imputed using LOCF.||participants|||Number
66976|NCT01138007|Secondary|Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8|The MADRS scale measures the depression level of a participant using the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). Scores for MADRS items 1, 2, 6, 7, and 8 were evaluated for this endpoint. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score of each item and region as covariates.|Baseline; Week 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
66977|NCT01138007|Secondary|Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 1, 2, 4 and 6 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|Baseline; Weeks 1, 2, 4, and 6|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
66978|NCT01138007|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.|Baseline and Week 8/Withdrawal|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e. Week 1 or later). Missing values were imputed using Last Observation Carried Forward (LOCF): last observed non-missing value was used to fill missing values at a later point.||Scores on a scale||Standard Error|Least Squares Mean
66979|NCT01137812|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
66980|NCT01137812|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
66981|NCT01137812|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
66982|NCT01137812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
66983|NCT01137812|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
67150|NCT01136408|Secondary|Frequency (Occurrence Rates) of Death|The percentage of patients with death|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
66985|NCT01137812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
66986|NCT01137786|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48 and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of non-ionic low osmolar contrast media.|Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
66987|NCT01137682|Secondary|PK Levels of Pasireotide LAR 40 mg and Pasireotide LAR 60 mg||24 Weeks||12/2016||||
66988|NCT01137682|Secondary|Change From Baseline in Health Related QoL as Measured by the AcroQoL (Acromegaly Health Related QoL)||Baseline, 24 Weeks||12/2016||||
66989|NCT01137682|Secondary|Change From Baseline in Clinical Signs/Symptoms of Acromegaly (Ring Size; Headache, Fatigue, Perspiration, Paresthesias and Osteoarthralgia According to a Five-point Score Scale)||Baseline, 24 Weeks||12/2016||||
66990|NCT01137682|Secondary|Percent Change in Tumor Volume Assessed by Pituitary MRI.||Baseline, 24 Weeks||12/2016||||
66991|NCT01137682|Secondary|Percentage of Participants Achieving a Tumor Volume Reduction > 25% Assessed by Pituitary MRI.||24 Weeks||12/2016||||
66992|NCT01137682|Secondary|Percentage of Participants Achieving GH Levels < 1 µg/L.||Weeks 12 and 24||12/2016||||
66993|NCT01137682|Secondary|Percentage of of Participants Achieving GH Levels < 1 µg/L and Normal, Sex- and Age-adjusted IGF-1.||Weeks 12 and 24||12/2016||||
66994|NCT01137682|Secondary|Percentage of Participants Achieving GH Levels < 2.5 µg/L.||Weeks 12 and 24||12/2016||||
66995|NCT01137682|Secondary|Percentage of Participants Achieving Biochemical Control Defined as Mean GH Levels < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.||12 Weeks||12/2016||||
66996|NCT01137682|Secondary|Perecentage of Participants Achieving Normalization of Sex- and Age-adjusted IGF-1|The key secondary objective is to compare the effect of pasireotide LAR (40 mg and 60 mg separately) versus continuing the same treatment on the proportion of patients achieving normalization of sex- and age-adjusted IGF-1 at 24 weeks. The endpoint for the key secondary objective is the proportion of patients achieving normalization of sex- and age-adjusted IGF-1 at 24 weeks.|24 weeks|Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.||Percentage of Participants||95% Confidence Interval|Number
66997|NCT01137682|Primary|Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.|The primary objective of this study was to compare the proportion of patients achieving biochemical control (defined as mean GH levels <2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to < 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.|24 weeks|Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.||Percentage of Participants||95% Confidence Interval|Number
66998|NCT01137604|Primary|Progression Free Survival (PFS) Rate at Month 6|PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS.|At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3)|Full Analysis Set included all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
66999|NCT01137604|Secondary|Pharmacokinetic (PK) Profile and Pharmacodynamics (PD) of Lenvatinib|Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.|Blood samples collected at Cycle 1 on Days 1 and 15 and in Cycle 2 on Day 1||||||
67000|NCT01137604|Secondary|Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.|For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Participants|||Number
67001|NCT01137604|Secondary|Clinical Benefit Rate (CBR)|CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
67474|NCT01133665|Secondary|Number of Participants With Fever Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67002|NCT01137604|Secondary|Disease Control Rate (DCR)|DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
67003|NCT01137604|Secondary|Overall Survival (OS)|OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Months||95% Confidence Interval|Median
67004|NCT01137604|Secondary|Progression Free Survival|PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug||Months||95% Confidence Interval|Median
67005|NCT01137604|Secondary|Objective Response Rate (ORR)|ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years)|Full Analysis Set included all participants who received at least one dose of study drug||Percentage of participants||95% Confidence Interval|Number
67006|NCT01137578|Primary|All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT|Adjudication was by an Independent Central Adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. One set of 3 study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|n=participants with an adjudicated DVT identified by a study-related adjudicated radiographic procedure.||participants|||Number
67007|NCT01137578|Primary|Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group|MRI with contrast (c) and without (w/o) contrast (c) enhancement were performed and a US was done within 48 hours of the MRI. Once detected, the DVT was adjudicated and confirmed by an independent central adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. Participants were considered positive for DVT if at least one of the radiographic procedures was positive. Cohort A: Day 0=day of catheter placement; Day 40 (± 20 days)=day of imaging procedures at Visit 1, or if possible within 72 hours after a CVC is removed or lost. Cohort B Visit 1: within 7 days of initiation of symptoms of a CVC-related DVT (symptoms include but were not limited to: redness, pain/tenderness, swelling, presence of subcutaneous collaterals, catheter occlusion, and the presence of catheter related infection) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure. n=number of adjudicated images||participants|||Number
67008|NCT01137578|Secondary|Number of Deaths Which Occurred During the Study|Death as an endpoint in a participant with an adjudicated venous thromboembolism (DVT or PE) was summarized, regardless of the cause of the death. The VTE was adjudicated by a blinded central independent adjudication committee.|Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.||participants|||Number
67016|NCT01137474|Secondary|Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
67294|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Follicle Stimulating Hormone|The change between follicle stimulating hormone (FSH) measured at year 5 in males including final visit and follicle stimulating hormone measured at baseline.|Baseline and Year 5.|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.||IU/L||Standard Deviation|Mean
67009|NCT01137578|Primary|Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast|Bilateral US was attempted but if it could not be completed, a unilateral US was accepted for analysis. Participants who did not complete the MRI procedure with contrast could be different participants from those who did not complete the MRI procedure without contrast. Primary reasons for non-completion of imaging included: technical, investigator decision, child refused, parent refused, child missed appointment, difficulties with anesthesia/sedation, child unable to lie still, problems with contrast administration, and other reasons. Other reasons could include: late to appointment and unable to perform MRI due to time constraints; logistical reasons, parent agreed to only ultrasound at time of consent, schedule delay, equipment not available, difficulty putting patient in correct position. Due to the small numbers of participants in some cohorts, these data were more meaningful with all cohorts grouped together for the total imaged population.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|Participants had at least 1 radiographic procedure performed but were unable to complete a either an Ultrasound (neither bilateral or unilateral, or could complete only a unilateral US) and/or unable to complete an MRI with contrast and/or unable to complete an MRI without contrast.||participants|||Number
67010|NCT01137578|Primary|Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age|One set of diagnostic imaging procedures (US and MRI) was to be performed for all cohorts The MRI consisted of MRI venous imaging without contrast enhancement and MRI venous imaging with contrast enhancement.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all participants who had at least 1 study-related diagnostic imaging procedure.||participants|||Number
67011|NCT01137578|Secondary|Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study|Signs and symptoms of PE include shortness of breath, pleuritic pain, cough, orthopnea, wheezing, and may have associated signs and symptoms of DVT. In the event a PE was detected while undergoing the study MRI or other imaging procedure required for care of an underlying condition, and the participant did not manifest any signs and/or symptoms of a PE, the event was considered an asymptomatic PE. The participant was managed and further investigated according to the investigator’s standard of care. All diagnostic imaging procedures performed, such as contrast-enhanced computer tomography (CT) pulmonary angiogram, nuclear ventilation perfusion lung scan (V/Q scan), were submitted for adjudication as a suspected PE.|Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.||participants|||Number
67012|NCT01137578|Secondary|Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment|Adjudication was by an ICAC consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. One set of Study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|All participants who had an adjudicated DVT identified by at lest one study-related radiographic procedure.||Participants|||Number
67013|NCT01137578|Primary|Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group|Imaging was performed on Visit 1 which was defined for Cohort A as: Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 defined for Cohort B: within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI. All 3 imaging procedures, ultrasound, MRI with contrast, MRI without contrast were to be performed on all participants, regardless of the cohort.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.||participants|||Number
67014|NCT01137578|Primary|Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast|One set of 3 diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Imaging was performed on Visit 1, which in Cohort A was Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 in Cohort B was within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI, which was scheduled for a clinical reason. Note: participants completing each MRI procedure (with contrast or without contrast) could be different participants.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.||participants|||Number
67015|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12|Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mg/dL||Standard Error|Mean
67755|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at Week 8||56 Days|Participants with available data at Week 8.||percentage of participants|||Number
67017|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12|All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
67018|NCT01137474|Secondary|Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
67019|NCT01137474|Primary|Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12|HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||Percent||Standard Error|Mean
67020|NCT01137474|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12|Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.||mm Hg||Standard Error|Mean
67021|NCT01137435|Other Pre-specified|Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™|"Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.~All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period."|7 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Number of Events|||Number
67022|NCT01137435|Other Pre-specified|Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Participants|||Number
67023|NCT01137435|Other Pre-specified|Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™|Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Participants|||Number
67024|NCT01137435|Primary|Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.||Participants|||Number
67025|NCT01137396|Secondary|Change in N3 (Slow-wave) Sleep Time||change from week 1 to week 2 of inpatient treatment|||minutes||Standard Error|Mean
67026|NCT01137396|Primary|%Cocaine Free Urines||3x/week|||percent||Standard Error|Mean
67027|NCT01137370|Primary|Median 25-OHD Level||August 2010 to March 2011||10/2011||||
67028|NCT01137370|Primary|Prevalence of Vitamin D Deficiency||At enrollment|||participants, %|||Number
67029|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the tolerability of voriconazole at the EOT Visit.||participants|||Number
67030|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the efficacy of voriconazole at the EOT Visit.||participants|||Number
67555|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at Baseline|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67031|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|more than 2 weeks (Test-of-Cure visit)|FAS.||participants|||Number
67032|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|up to 2 weeks (EOT visit)|Full Analysis Set (FAS) = all enrolled participants who were administered the study medication and had post baseline documentation of efficacy available.||participants|||Number
67033|NCT01137071|Secondary|Two-year Overall Survival: Median Time to Death|Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy. Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|Within the ITT population, 7 patients died and 22 were censored. The median time to death was 25.1 months (95% CI, 16.7 to 32.4 months).||months||95% Confidence Interval|Median
67034|NCT01137071|Secondary|Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)|Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.|Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9|PK samples were analyzed from 10 patients. Dose: 30 mg/m2 every two weeks||(µg/mL)||Standard Deviation|Mean
67035|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67036|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient’s hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67037|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67038|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67039|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67151|NCT01136408|Secondary|Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events|The percentage of patients with other major adverse cardiac events|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67040|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67041|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67042|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67043|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67044|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67045|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67046|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67047|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)|The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67048|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67088|NCT01137071|Secondary|Two-year Overall Survival Rate|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy. Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.||percentage of participants|||Number
67049|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67050|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67051|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67052|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67053|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67054|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67055|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67056|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67057|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67089|NCT01137071|Secondary|1-year Disease Progression-free Survival Rate||1 year from the beginning of platinum-based rescue chemotherapy start date|In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.||percentage of participants|||Number
67756|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at Week 4||28 Days|Participants with available data at Week 4.||percentage of participants|||Number
67058|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67059|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67060|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67061|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67062|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67063|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67064|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67065|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67066|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67134|NCT01136746|Secondary|Mean Plasma Glucose (MPG) by Hospital Day|The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7.|Day 1 up to day 7 of hospital study period|All randomized participants who had at least one post-baseline glucose measurement and a plasma glucose measurement at specified timepoint.||mg/dL||Standard Deviation|Mean
67067|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67068|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67069|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67070|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67071|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67072|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67073|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67074|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67075|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67076|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67077|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67078|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67079|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67080|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67081|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67082|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67083|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.||Incidence|||Number
67084|NCT01137071|Secondary|Safety - Vital Signs - Temperature|Vital signs were assessed throughout the study treatment.|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14||°C||Standard Deviation|Median
67085|NCT01137071|Secondary|Safety - Vital Signs - Systolic and Diastolic Blood Pressure|Both parameters were assessed throughout the study treatment.|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14||mmHg||Standard Deviation|Median
67086|NCT01137071|Secondary|Safety - Vital Signs - Respiratory Rate|Vital signs were assessed throughout the study treatment.|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14||ipm (Incursions per minute)||Standard Deviation|Median
67087|NCT01137071|Secondary|Safety - Vital Signs - Heart Rate|Vital signs were assessed throughout the study treatment.|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14||bpm||Standard Deviation|Median
67135|NCT01136746|Primary|Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period|Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.||percentage of capillary PG measurements|Participants||Number
67090|NCT01137071|Primary|1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy|"PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.~Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented."|1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.|In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).||Months||95% Confidence Interval|Median
67091|NCT01137032|Secondary|and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.||22 days|15 subjects represents the subgroup utilized for the analysis of this endpoint.||participants|||Number
67092|NCT01137032|Secondary|Pre-injection Serum Cortisol Levels|The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.||participants|||Number
67093|NCT01137032|Primary|Post-injection Serum Cortisol Level|The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.||participants|||Number
67094|NCT01136967|Secondary|Pharmacokinetics and Pharmacodynamics|Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.|Predose and 2 to 12 hours postdose at Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1||||||
67095|NCT01136967|Secondary|Number of Participants With Adverse Events (AEs)/ Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECGs), and multi-gated acquisition (MUGA) scans or echocardiogram.|For each participant, from the first patient first dose till 30 days after the last dose of study drug, up to approximately 2.9 years|Safety Analysis Set included those participants who received at least 1 dose of study drug and had at least 1 post baseline safety evaluation.||Participants|||Number
67096|NCT01136967|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who had a BOR of CR or PR or durable SD (SD lasting greater than or equal to 23 weeks) based on IRR and Investigator's assessment. CBR = CR + PR + durable SD rate|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Percentage of participants||95% Confidence Interval|Number
67097|NCT01136967|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in each cohort who had a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review (IRR). A BOR of CR required confirmation by a subsequent CR assessment at least 4 weeks later. A BOR of PR required confirmation by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.|From date of first dose of study drug until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to end of Cycle 6 by the date of data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) included all participants who received at least 1 dose study drug.||Percentage of participants||95% Confidence Interval|Number
67098|NCT01136967|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had a BOR of CR or PR or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD needed to be greater than or equal to seven weeks based on IRR and Investigator's assessment. DCR = CR + PR + SD|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Percentage of participants||95% Confidence Interval|Number
67099|NCT01136967|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date for each cohort.|From date of first dose of study drug until date of death from any cause or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Months||95% Confidence Interval|Median
67100|NCT01136967|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death from any cause (whichever occurred first), as determined by IRR and Investigator based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.||Months||95% Confidence Interval|Median
67475|NCT01133665|Secondary|Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 3|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67101|NCT01136954|Secondary|Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period. Percentage change = 100% x (seizure frequency at period - seizure frequency at Study 312 baseline)/seizure frequency at Study 312 baseline.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population||Percentage Change||Full Range|Median
67102|NCT01136954|Secondary|Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population||Seizures||Full Range|Median
67103|NCT01136954|Secondary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants'parent or guardian maintained a seizure diary recording the date,number, and type of seizures the subject had. The primary analysis assessed the percent of responders from baseline in the Open Label Visit Period. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline through Week 59|Safety Population||Percentage of Participants|||Number
67104|NCT01136954|Primary|Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency|Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.|Week 1 through Week 59|Safety Population (all subjects who entered the study and received at least one dose of study drug)||Participants|||Number
67105|NCT01136915|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2,4,6,24, 48, and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
67106|NCT01136876|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
67107|NCT01136772|Secondary|Changes in Psychiatric Symptoms|The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.|Baseline to 6 months|Participants with PANSS scores at 6 months||Units on a scale||95% Confidence Interval|Mean
67108|NCT01136772|Primary|Efficacy Failure|Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.|24 months|All randomized participants who received an injection and attended one follow-up appointment||participants|||Number
67109|NCT01136746|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67110|NCT01136746|Secondary|Percentage of Participants With Documented Nosocomial Infections|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67111|NCT01136746|Secondary|Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period|Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67112|NCT01136746|Secondary|Percentage of Participants Requiring Intensive Care Unit Transfer|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67113|NCT01136746|Secondary|Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period|Treatment-emergent adverse event – any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants||participants|||Number
67114|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67136|NCT01136746|Primary|Mean Plasma Glucose (MPG) Throughout Hospital Study Period|Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
67115|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67116|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67117|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.||hypoglycemic episodes|||Number
67118|NCT01136746|Secondary|Length of Hospital Stay Post-randomization Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67119|NCT01136746|Secondary|TDD of Insulin (Units/kg) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67120|NCT01136746|Secondary|TDD of Insulin (Units) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67121|NCT01136746|Secondary|TDD of Insulin (Units/kg) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67122|NCT01136746|Secondary|Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67123|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67124|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67125|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67126|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67127|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67128|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67129|NCT01136746|Secondary|Mean FPG Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67130|NCT01136746|Secondary|Mean Fasting Plasma Glucose (FPG) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67131|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67132|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.|||||
67133|NCT01136746|Secondary|Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.|||||
67757|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 – 5.5 mEq/L at Week 8||56 Days|Participants with available data at Week 8.||percentage of participants|||Number
67137|NCT01136655|Secondary|Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug|The amount of formoterol excreted unchanged in urine over the 12-hour period after administration [Ae(0-12h)] was calculated from the concentration of formoterol in urine multiplied by the total volume of urine collected. Volume was determined from the weight of the collected urine times an assumed urine density of 1020 g/L. The data for six patients who did not have measurable formoterol in their urine on the Foradil 12 μg treatment day was excluded from the analysis. All other urine concentrations below the lower limit of quantification were set to zero. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|0 to 12 hours|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||pmol||95% Confidence Interval|Least Squares Mean
67138|NCT01136655|Secondary|Maximal FEV1 During the 12-hour Study Period|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. The maximum FEV1 value was defined as the largest observed FEV1 value recorded during each 12-hour serial spirometry procedure. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
67139|NCT01136655|Secondary|FEV1 at 12 Hours After Study Medication Inhalation|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. The FEV1 value at 12 hours after dosing was taken as the 12-hour measurement (720 minutes) from the serial spirometry. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|12 hours after dosing|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
67140|NCT01136655|Primary|Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.||liters||Standard Error|Least Squares Mean
67141|NCT01136486|Primary|Assessment of Pain Severity|Pain was assessed on a scale for 1 (no pain) to 10 (severe) pain. This is observational study so participants were only seen at one time point, when they were referred to the neuropsychology service.|Referral|||units on a scale||Standard Deviation|Mean
67142|NCT01136408|Primary|Changes in Laboratory Test Values|The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range|12 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||participants|||Number
67143|NCT01136408|Secondary|Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration||Week 1,4 and 12|Full Analysis Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
67144|NCT01136408|Secondary|Anticoagulation Effects Trough 11-dehydrothromboxane B2|Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients.|Week 0 and 12|Per Protocol Analysis Set||pg/mg creatinine||Geometric Coefficient of Variation|Geometric Mean
67145|NCT01136408|Secondary|Anticoagulation Effects Trough INR (International Normalised Ratio)|The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set||ratio||Geometric Coefficient of Variation|Geometric Mean
67146|NCT01136408|Secondary|Anticoagulation Effects Trough ECT (Ecarin Clotting Time)|The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set||seconds||Geometric Coefficient of Variation|Geometric Mean
67147|NCT01136408|Secondary|Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)|The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set||seconds||Geometric Coefficient of Variation|Geometric Mean
67148|NCT01136408|Primary|Discontinuation of the Study Drug Due to Adverse Events|Discontinuation of the study drug due to adverse events.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||participants|||Number
67152|NCT01136408|Secondary|Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)|The percentage of patients with myocardial infarction (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67153|NCT01136408|Secondary|Frequency (Occurrence Rates) of Systemic Embolism|The percentage of patients with systemic embolism|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67154|NCT01136408|Secondary|Frequency (Occurrence Rates) of Transient Ischemic Attack|The percentage of patients with transient ischemic attack|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67155|NCT01136408|Secondary|Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)|The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67156|NCT01136408|Secondary|Frequency (Occurrence Rates) of a Composite Clinical Endpoint.|Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67157|NCT01136408|Primary|Frequency (Occurrence Rates) of Nuisance Bleeding Event|"The percentage of patients with nuisance bleeding event~Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator"|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67158|NCT01136408|Primary|Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event|"The percentage of patients with clinically relevant bleeding event.~Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67159|NCT01136408|Primary|Frequency (Occurrence Rates) of Major Bleeding Event|"The percentage of patients with major bleeding event.~Major bleeding was defined as any bleed fulfilling one of the following conditions:~Fatal or life-threatening~Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)~Bleeding requiring surgical treatment~Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more~Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.||Percentage of patients|||Number
67160|NCT01136382|Secondary|Number of Withdrawals Due to Pre-defined Asthma Events|Patients were considered to have experienced a “pre-defined asthma event” if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||participants|||Number
67758|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 – 5.5 mEq/L at Week 4||28 Days|Participants with available data at Week 4.||percentage of participants|||Number
67161|NCT01136382|Secondary|Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average|The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||inhalations per day||Standard Error|Least Squares Mean
67162|NCT01136382|Secondary|Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average|The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||inhalations per day||Standard Error|Least Squares Mean
67163|NCT01136382|Secondary|Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, “Did your asthma cause you to wake-up last night?” If yes, patients were asked, “Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?” Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||percentage of days with awakenings||Standard Error|Least Squares Mean
67164|NCT01136382|Secondary|Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
67165|NCT01136382|Secondary|Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||units on a scale||Standard Error|Least Squares Mean
67166|NCT01136382|Secondary|Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average|FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters/second||Standard Error|Least Squares Mean
67167|NCT01136382|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average|FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters||Standard Error|Least Squares Mean
67168|NCT01136382|Secondary|Change in Evening PEF From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters/minute||Standard Error|Least Squares Mean
67169|NCT01136382|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters||Standard Error|Least Squares Mean
67188|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg Without BIBF 1120 (after lunch)|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
67170|NCT01136382|Primary|Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.||liters/minute||Standard Error|Least Squares Mean
67171|NCT01136291|Secondary|Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)|All pregnant women responded to the quality of life WHOQOL-bref questionnaire, at study inclusion and at the completion of 36 gestational weeks. The domains of these questionnaires were calculated on a scale of zero (the worse quality of life) to 100 points (the better quality of life).|at the 14 and at the 40 gestational weeks|||scores on a scale||Standard Deviation|Mean
67172|NCT01136291|Primary|Weight Gain During the Program|Weight gain during the program was the difference between the weight measured at study entry and final consultation weight, measured by a mechanical scale, in kilos and grams|at the 14 to 40 gestational weeks|||kg||Standard Deviation|Mean
67173|NCT01136291|Primary|Gestational Weight Gain|Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy|baseline and at 40 gestational weeks|||kg||Standard Deviation|Mean
67174|NCT01136226|Secondary|Safety Assessments|Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire|6 months||||||
67175|NCT01136226|Primary|Serum Testosterone Recovery|To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer|6 mos|||Months||Full Range|Mean
67176|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC)|Change in Forced Vital Capacity percent of predicted (%FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||% predicted||Standard Deviation|Mean
67177|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity (FVC)|Change in forced vital capacity (FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||Liter||Standard Deviation|Mean
67178|NCT01136174|Secondary|Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1)|Change in forced expiratory volume in 1 second (FEV1) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||Liter||Standard Deviation|Mean
67179|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco)|Change in Diffusing Capacity for Carbon Monoxide percent of predicted (%DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set- Only patients with valid measurements were analysed.||% predicted||Standard Deviation|Mean
67180|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco)|Change in diffusing capacity for carbon monoxide (DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||mL/min/mmHg||Standard Deviation|Mean
67181|NCT01136174|Secondary|Change From Baseline in Pulse Rate|Change from baseline in pulse rate at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||bpm||Standard Deviation|Mean
67182|NCT01136174|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set||mmHg||Standard Deviation|Mean
67183|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - With pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
67184|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - No pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
67185|NCT01136174|Secondary|Withdrawal Due to Adverse Event|Number of patients prematurely discontinued from trial medication due to adverse event.|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
67186|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
67187|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
67189|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after lunch) in the time frame mentioned.|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
67190|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
67191|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
67192|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast)|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set-Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
67193|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast) in the time frame mentioned.|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
67194|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
67195|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone in the time frame mentioned.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
67196|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed||ng/mL||Geometric Coefficient of Variation|Geometric Mean
67197|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone in the time frame mentioned.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
67198|NCT01136174|Primary|Drug-related Adverse Events|The number of patients with drug-related adverse events stratified according to pirfenidone use in each group|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set||participants|||Number
67759|NCT01130597|Primary|Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment||56 days|||percentage of participants|||Number
67199|NCT01135992|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator||episodes per 100 patient years|||Number
67200|NCT01135992|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.||episodes per 100 patient years|||Number
67201|NCT01135992|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject’s daily activities. Moderate AEs: marked symptoms, moderate interference with subject’s daily activities. Severe AEs: considerable interference with subject’s daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.||events per 100 patient years|||Number
67202|NCT01135992|Secondary|Change in Body Weight|Change from baseline in body weight after week 4 and after week 16|Week 0, Week 4, Week 16|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using LOCF (last observation carried forward)||kg||Standard Deviation|Mean
67203|NCT01135992|Secondary|Fasting Plasma Glucose (FPG)|FPG at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment||mmol/L||Standard Deviation|Mean
67204|NCT01135992|Primary|HbA1c (Glycosylated Haemoglobin)|HbA1C at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment||percentage of glycosylated haemoglobin||Standard Deviation|Mean
67205|NCT01135914|Secondary|Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12|(TTO) questionnaire was used to help determine the patients’ health utility. Reported health utility represents the patients’ quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision.|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included||Units on a scale||Standard Deviation|Mean
67206|NCT01135914|Secondary|EuroQoL (EQ-5D) Utility Score at Month 12|The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1=“no problems”, 2=”some problems” and 3=”extreme problems”. Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health).|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included||Units on a scale||Standard Deviation|Mean
67207|NCT01135914|Secondary|National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included||Units on a Scale||Standard Deviation|Mean
67208|NCT01135914|Secondary|Percentage of Patients Achieving Gain of Letters From Baseline in BCVA|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement.|12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with 12 month data were included||Percentage of Patients|||Number
67209|NCT01135914|Secondary|Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response.|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT||Percentage of Patients|||Number
67210|NCT01135914|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12|OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.||um||Standard Deviation|Mean
67211|NCT01135914|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline, 3, 6 and 9 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.||Letters||Standard Deviation|Mean
67212|NCT01135914|Primary|Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline and 12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. patients with both baseline and 12 month data were included.||Letters||Standard Deviation|Mean
67213|NCT01135524|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|52 weeks|The Extension Safety Population (N = 196) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.||participants|||Number
67214|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||mcg/mL||Standard Deviation|Mean
67215|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||mcg/mL||Standard Deviation|Mean
67216|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||Relative unit/mL||Standard Deviation|Mean
67217|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||Relative unit/mL||Standard Deviation|Mean
67218|NCT01135511|Other Pre-specified|Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4|"Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 4 and 8|A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.||Participants|||Number
67219|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||Relative unit/mL||Standard Deviation|Mean
67220|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||mcg/mL||Standard Deviation|Mean
67221|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67222|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
67223|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67224|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67225|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67226|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67227|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67228|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
67229|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67230|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
67231|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
67232|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
67233|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67234|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67235|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67236|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67237|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67238|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67239|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67240|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||pg/mL||Standard Deviation|Mean
67241|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."||ng/mL||Standard Deviation|Mean
67295|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Luteinizing Hormone|The change between luteinizing hormone measured at year 5 in males including final visit and luteinizing hormone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.||IU/L||Standard Deviation|Mean
67242|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye|"Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.||Percentage of positive cells||Standard Deviation|Mean
67243|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye|"The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC).~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = value at observation minus value at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.||Antibodies bound per cell||Standard Deviation|Mean
67244|NCT01135511|Secondary|Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale|"Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.||Participants|||Number
67245|NCT01135511|Secondary|Number of Participants With Nonocular Adverse Events (AEs) by Severity|Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.||Participants|||Number
67246|NCT01135511|Secondary|Number of Participants With Ocular Adverse Events (AEs)by Severity|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.||Participants|||Number
67247|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores|The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Participants|||Number
67248|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Participants|||Number
67249|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.~100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Participants|||Number
67250|NCT01135511|Secondary|Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Percentage of participants|||Number
67251|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
67296|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Testosterone|The change between testosterone measured at year 5 in males including final visit and Testosterone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.||µg/L||Standard Deviation|Mean
67252|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].~Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
67253|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
67254|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
67255|NCT01135511|Secondary|Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Participants|||Number
67256|NCT01135511|Secondary|Changes in the Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
67257|NCT01135511|Secondary|Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Participants|||Number
67258|NCT01135511|Secondary|Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.||Percentage of participants|||Number
67281|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye|The retinal aspect of the left eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67259|NCT01135511|Secondary|Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Millimeters||Standard Deviation|Mean
67260|NCT01135511|Secondary|Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline|"TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Seconds||Standard Deviation|Mean
67261|NCT01135511|Secondary|Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline|"Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
67262|NCT01135511|Secondary|Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye|"Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.||Percentage of participants|||Number
67263|NCT01135511|Secondary|Changes in Corneal Staining Scores for Study Eye From Baseline|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2 and 4|Intent-to-treat population: Participants who received at least 1 dose of study treatment.||Units on a scale||Standard Deviation|Mean
67264|NCT01135511|Primary|Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.||Units on a scale||Standard Deviation|Mean
67265|NCT01135498|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up.|From study start up to approximately 4 years|ITT population||months||95% Confidence Interval|Median
67266|NCT01135498|Primary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).|From study start up to approximately 4 years|ITT population||months||95% Confidence Interval|Median
67267|NCT01135498|Secondary|Percentage of Participants Who Died||From study start up to approximately 4 years|ITT population||percentage of participants|||Number
67268|NCT01135498|Secondary|Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])|Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|From study start up to approximately 4 years|Response-Evaluable population||percentage of participants|||Number
67327|NCT01134952|Secondary|Delta Tacrolimus Trough Level|Percent change determined 3 months after switch from MMF to SRL|3 month|2 patients did not have tacrolimus levels recorded during both time periods and are excluded||percent change||Standard Deviation|Mean
67328|NCT01134952|Secondary|Sirolimus Trough Level||3 month|||ng/ml||Standard Deviation|Mean
67269|NCT01135498|Secondary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])|Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From study start up to approximately 4 years|Response-Evaluable population: all enrolled participants who received at least 3 cycles of treatment, had all baseline lesions evaluated at least once after receiving the third cycle (using same technique as at baseline), and were without major violations of the study protocol.||percentage of participants|||Number
67270|NCT01135498|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Start of study to approximately 4 years|ITT population||percentage of participants|||Number
67271|NCT01135420|Primary|Readiness to Attend Substance Use Disorder Continuing Care|Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.|3 months post-intervention|||units on a scale||Standard Deviation|Mean
67272|NCT01135381|Secondary|Community Tenure|The number of days a patient spends in the home versus the hospital at 30 days.|30 days|||days||Standard Deviation|Mean
67273|NCT01135381|Secondary|Rehospitalizations at 90 Days||90 days|||participants|||Number
67274|NCT01135381|Primary|Re-hospitalizations||During the 30days after discharge|||participants|||Number
67275|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye|The macula lutea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67276|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye|The macula lutea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67277|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye|The retinal blood vessels of the left eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67278|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye|The retinal blood vessels of the right eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67279|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye|The optic nerve and papilla of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67280|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye|The optic nerve and papilla of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67293|NCT01135368|Secondary|Ophthalmologic Examination - Visual Acuity|Visual Acuity was measured using the Snellen eye chart at a distance of 6 meters. Acuity is expressed as a ratio of the test distance (6 M) / the distance the average eye can see the letters on a certain line of the eye chart. Visual acuity of 1 is normal; an individual with acuity of 0.5 could only recognize an object at half the distance compared to an individual with normal acuity.|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||ratio||Standard Deviation|Mean
67282|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye|The retinal aspect of the right eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67283|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye|"The vitreous body of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67284|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye|"The vitreous body of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67285|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye|"The lens of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67286|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye|"The lens of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67287|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye|The cornea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67288|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye|The cornea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67289|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Color Vision|Color vision was assessed by an Ophthalmologist and classified as normal or pathological. Pathological findings include abnormal color vision tests, color blindness and anomalous quotient. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in color vision classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67290|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Accommodation|Accommodation is the adjustment of the focal length of the eye lens to keep an object in focus on the retina as its distance from the eye varies, and is measured in diopters: Diopters = 1/(focal length).|Baseline and Year 5|Safety analysis where data were available. Last observation carried forward was utilized.||diopters||Standard Deviation|Mean
67291|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation With Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation with glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation with glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67292|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation without glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation without glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.||participants|||Number
67297|NCT01135368|Secondary|Change From Baseline in Corpus Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
67298|NCT01135368|Secondary|Change From Baseline in Antrum Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
67299|NCT01135368|Secondary|Change From Baseline in Corpus Chronic Inflammation Score|Chronic inflammation of the corpus was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe.|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||scores on a scale||Standard Deviation|Mean
67300|NCT01135368|Secondary|Change From Baseline in Average Antrum Chronic Inflammation Score|Chronic inflammation of the antrum was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||scores on a scale||Standard Deviation|Mean
67301|NCT01135368|Secondary|Change From Baseline in Corpus Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
67302|NCT01135368|Secondary|Change From Baseline in Antrum Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
67303|NCT01135368|Secondary|Change From Baseline in Enterochromaffin-like Cell Hyperplasia|"Enterochromaffin-like (ECL) cells were evaluated and classified by histopathological examinations as Normal, Simple (diffuse) hyperplasia, or Linear, chain producing hyperplasia.~The shift table below summarizes the individual transitions in ECL-cell classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows) for all patients."|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.||participants|||Number
67304|NCT01135368|Primary|Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy|Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks >5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are <75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
67305|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat|Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
67306|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting|Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
67307|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen|Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
67308|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing|Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
67329|NCT01134952|Secondary|Final Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from SRL to MMF|3 month|||percent change||Standard Deviation|Mean
67309|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation|Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
67310|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Heartburn|Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.||participants|||Number
67311|NCT01135134|Secondary|Change From Baseline in the Total Nasal Symptom Score at 1 Week|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 1 week|||score on a scale||Standard Error|Least Squares Mean
67312|NCT01135134|Primary|Change From Baseline in the Total Nasal Symptom Score at 2 Weeks|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 2 weeks (or discontinuation)|||score on a scale||Standard Error|Least Squares Mean
67313|NCT01135069|Primary|Improvement in Acne|Counting of acne lesions both inflammatory and non-inflammatory|12 weeks|||Percent change||Standard Deviation|Mean
67314|NCT01135017|Other Pre-specified|Overview of Adverse Events (AE)|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|All randomized and treated participants. Participants were considered according to the treatment actually received.||participants|||Number
67315|NCT01135017|Secondary|Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)|"Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias.~Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study."|12 weeks|Modified intent-to-treat population as previously defined||participants|||Number
67316|NCT01135017|Secondary|Atrial Fibrillation Severity Scale (AFSS) Scores|"The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm.~AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden.~AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms."|Baseline (before randomization) and 12 weeks after randomization|Modified intent-to-treat population as previously defined||units on a scale||Standard Deviation|Mean
67317|NCT01135017|Secondary|Average Ventricular Rate During AF Episodes|"Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review.~The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined||beats/min||Standard Deviation|Mean
67318|NCT01135017|Secondary|AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment|AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab|4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined||percent time in AF||95% Confidence Interval|Geometric Mean
67319|NCT01135017|Primary|Atrial Fibrillation (AF) Burden During the 12-week Treatment Period|"AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator.~AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|The analysis included all randomized and treated participants with post-baseline AF burden assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).||percent time in AF||95% Confidence Interval|Geometric Mean
67320|NCT01134952|Secondary|Delta Triglyceride Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available on 2 patients||percent change||Standard Deviation|Mean
67321|NCT01134952|Secondary|Delta Cholesterol Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available for 2 patients||percent change||Standard Deviation|Mean
67322|NCT01134952|Secondary|Delta Platelet Count|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available on 2 patients at appropriate time||percent change||Standard Deviation|Mean
67323|NCT01134952|Secondary|Delta Hemoglobin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available in 2 patients||percent change||Standard Deviation|Mean
67324|NCT01134952|Secondary|Delta Alanine Aminotransferase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate time not available in 2 patients||percent change||Standard Deviation|Mean
67325|NCT01134952|Secondary|Delta Alkaline Phosphatase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available at appropriate times in 2 patients||percent change||Standard Deviation|Mean
67326|NCT01134952|Secondary|Delta Bilirubin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels available at correct time in only 7 patients||percent change||Standard Deviation|Mean
67330|NCT01134952|Primary|Delta Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from MMF to SRL.|3 month|||percent change||Standard Deviation|Mean
67331|NCT01134939|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for haemoglobin at baseline and at month 36.||g/dL||Standard Deviation|Mean
67332|NCT01134939|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for creatinine at baseline and at month 36.||mg/dL||Standard Deviation|Mean
67333|NCT01134939|Secondary|Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.||U/L||Standard Deviation|Mean
67334|NCT01134939|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for the AST at baseline and at month 36.||U/L||Standard Deviation|Mean
67335|NCT01134939|Secondary|Changes in the Laboratory Data ( ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.||U/L||Standard Deviation|Mean
67336|NCT01134939|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for blood glucose at baseline and at month 36.||mg/dL||Standard Deviation|Mean
67337|NCT01134939|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for triglycerides at baseline and at month 36.||mg/dL||Standard Deviation|Mean
67338|NCT01134939|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for LDL cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
67339|NCT01134939|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for HDL cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
67340|NCT01134939|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for total cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
67341|NCT01134939|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.||cells/mm^3||Standard Deviation|Mean
67342|NCT01134939|Secondary|Changes in the Viral Load After 36 Months From Baseline|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.||Log10 copies/mL||Standard Deviation|Mean
67343|NCT01134939|Primary|Number of Patients With Virologic Response (VR) After 36 Months|"VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart.~A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml."|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.||participants|||Number
67344|NCT01134900|Secondary|Time to Provider Response|Time from study event to modification or discontinuation of targeted medication|Until patient discharge (~2 week average)|||Hours|Participants|Inter-Quartile Range|Median
67498|NCT01133665|Secondary|Number of Participants With Fatigue Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67345|NCT01134900|Primary|Adverse Drug Events or Potential Adverse Drug Events|Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis.|Until patient discharge (~2 week average)|||Patient-Medication Pairs|Participants||Number
67346|NCT01134887|Primary|Patient Activation Measure|Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM). Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max). Rasch conversion changed raw scores to the PAM interval measure. Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up. If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score. Higher PAM scores represent higher levels of self-activation. Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence. Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2 (min) to 77 (max). Ranges for Follow-up PAM scores: Intervention = 48.4 (min) to 100 (max); Control = 45.1 (min) to 80.1 (max).|12 months|Veterans participating in CHOICE study randomized to two arms: intervention or attention control. The 13-item Patient Activation Measure was administered at baseline and up to two additional times during the following 12 months. Rasch conversion of the raw PAM scores was performed to ensure the final scores were linear and interval measures.||units on a scale||Standard Deviation|Mean
67347|NCT01134783|Secondary|Change in Weight From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||Kg||Standard Error|Mean
67348|NCT01134783|Secondary|Change in BMI From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||kg/m2||Standard Error|Mean
67349|NCT01134783|Secondary|Change in Weight From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||Kg||Standard Error|Mean
67350|NCT01134783|Secondary|Change in BMI From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||kg/m2||Standard Error|Mean
67351|NCT01134783|Secondary|Prevalence of Overweight/Obese|The prevalence of overweight/obese between intervention and control students|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||percentage of participants|||Number
67352|NCT01134783|Primary|Change in Body Mass Index (BMI)|The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.||kg/m2||Standard Error|Mean
67353|NCT01134731|Secondary|Mean Score of Montgomery-Asberg Depression Scale of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Montgomery-Asberg Depression Rating Scale will be used to measure depressive symptoms to determine the efficacy of the study drugs. It has 10 items (subscales) ranging from 0-6. Therefore the total score ranges from 0-60, with lower scores indicating better outcomes. The subscales were summed for a total score.|baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
67354|NCT01134731|Primary|Mean Score of Beck Scale for Suicidal Ideation of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.|baseline to 12 weeks|||units on a scale||Standard Deviation|Mean
67366|NCT01134627|Secondary|Changes in Brain Volume Measured on Magnetic Resonance Imaging (MRI)|Changes in brain volume were measured as the brain parenchymal fraction using MRI scans.|Screening , final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.||cubic millimeter (mm^3)||Standard Deviation|Mean
67355|NCT01134705|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.|Baseline and Week 6|The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
67356|NCT01134705|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
67357|NCT01134705|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
67358|NCT01134627|Other Pre-specified|Relapse Severity Based on Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5 and by at least 0.5 points if last EDSS was more than 5.5.|96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized to study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."||Units on a scale||Standard Deviation|Mean
67359|NCT01134627|Other Pre-specified|Number of Participants With Total Number of Reported Relapses (Documented and Undocumented Relapses)|Documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.||participants|||Number
67360|NCT01134627|Other Pre-specified|Number of Relapse Free Participants Without Progression|Analysis based on documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and overall relapses (documented and undocumented relapses); undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized and received study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."||participants|||Number
67361|NCT01134627|Other Pre-specified|Relapse Count|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, persisting for more than 48 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of the measure and the study was prematurely terminated.|||||
67362|NCT01134627|Other Pre-specified|Burden of Disease|The burden of disease (BOD) is the total area of MS lesions (abnormal plaques) in the brain measured on Time Constant 1 (T1) or T2 weighted MRI.|Baseline up to 96 weeks (+/- 1 week) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.||square millimeter (mm^2)||Standard Deviation|Mean
67363|NCT01134627|Other Pre-specified|Percentage of Time Constant 2 (T2) Active Scans Per Participant|Inflammatory disease activity was assessed by MRI measurement of the percentage of T2 active scans.|Baseline up to 96 weeks (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.|||||
67364|NCT01134627|Other Pre-specified|Number of Time Constant 2 (T2) Active Lesions|Inflammatory disease activity was assessed by MRI measurement of the number of T2 active lesions.|Week 48 up to Week 96 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.|||||
67365|NCT01134627|Other Pre-specified|Number of Participants With Onset of Disability Progression|Disability progression was defined as an increase, compared to baseline evaluation of >= 1.0 points on EDSS if EDSS was >= 1.0 at baseline or >=1.5 point on EDSS if EDSS was 0.0 at baseline. EDSS assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.||participants|||Number
67367|NCT01134627|Secondary|Number of New or Enlarging Lesions on Time Constant 2 (T2) Weighted Magnetic Resonance Imaging (MRI)|Inflammatory disease activity was assessed by MRI measurement of the number of new or enlarging T2 lesions.|Final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.||lesions||Standard Deviation|Mean
67368|NCT01134627|Secondary|Number of Participants With Documented Relapses|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation was >=1 point increase in 2 functional systems /2 points increase in 1 system, either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.||participants|||Number
67369|NCT01134627|Primary|Number of Participants Who Experienced First Documented Relapse|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation = at least (>=)1 point increase in 2 functional systems/2 points increase in 1 system,either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on expanded disability status scale (EDSS) which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).|Baseline up to 96 weeks (+/- 1 week) or early termination (ET)|The Intention to Treat (ITT) population included all the participants who were randomized and received study medication.||participants|||Number
67370|NCT01134614|Secondary|Proportion of Patients With Objective Response|Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
67371|NCT01134614|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.||Months||95% Confidence Interval|Median
67372|NCT01134614|Primary|Overall Survival|Overall survival is defined as the time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.||Months||95% Confidence Interval|Median
67373|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class II|"Donor Specific Antibodies [DSAs] Class II will be checked 1, 3, and 6 months post transplant to monitor allograft function.~DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Patients may have more than one DSA and points can add up to more than 10."|6 months|Mean Donor Specific Antibody (DSA) Class II levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.||DSA relative intensity score||Standard Deviation|Mean
67374|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class I|"Donor Specific Antibodies [DSAs] Class I will be checked 1, 3, and 6 months post transplant to monitor allograft function.~DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Patients may have more than one DSA and points can add up to more than 10."|6 months|Mean Donor Specific Antibody Class I levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.||DSA relative intensity score||Standard Deviation|Mean
67375|NCT01134510|Secondary|Serum Creatinine|Serum creatinine will be checked 6 months post transplant to monitor allograft function.|6 months|Mean serum creatinine levels at 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.||mg/dl (serum cr at 6m post transplant)||Standard Deviation|Mean
67376|NCT01134510|Primary|Post-transplant Biopsy to Identify Rejection Episodes|"Subjects will have a routine kidney biopsy 6 month after transplant to screen for episodes of acute rejection.~For purposes of this investigation, antibody-mediated rejection (AMR) is defined as follows:~Deterioration of allograft function in a high-risk transplant recipient (i.e. sensitized patient with history of Donor Specific Antibodies) measured by serum Creatinine and estimated Glomerular Filtration Rate~Association with the presence of Donor Specific Antibody (usually increasing in strength) measured by luminex techniques.~Biopsy evidence of capillaritis, inflammation and C4d deposition."|6 month|9 patients in each arm completed 6 month protocol biopsy. 1 patient in the placebo arm was withdrawn before 6M biopsy. 1 patient in treatment arm refused protocol biopsy.||Episode of rejection|||Number
67377|NCT01134393|Secondary|Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time||weeks 4 and 8|FAS||Number of participants|||Number
67476|NCT01133665|Secondary|Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67378|NCT01134393|Secondary|DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements|DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg|weeks 4, 8 and 12|FAS and LOCF and with at least one post baseline HBPM measurement||Number of participants|||Number
67379|NCT01134393|Secondary|Percentage of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|weeks 4, 8 and 12|FAS with non-missing data||Percentage of participants|||Number
67380|NCT01134393|Secondary|DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|weeks 4, 8 and 12|FAS and LOCF||Number of participants|||Number
67381|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure||weeks 4, 8 and 12|There was no information in the Case Report Form (CRF)|||||
67382|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate|Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.|weeks 4, 8 and 12|Treated Set (TS) with non-missing data||bpm||Standard Deviation|Mean
67383|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP||weeks 4, 8 and 12|FAS with non-missing data||mmHg||Standard Deviation|Mean
67384|NCT01134393|Secondary|BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).|Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg.|Week 12|FAS and LOCF and with at least one post baseline HBPM measurement||Number of participants|||Number
67385|NCT01134393|Secondary|BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|4 and 8 weeks|FAS and LOCF||Number of participants|||Number
67386|NCT01134393|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|12 weeks|Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.||Percentage of participants||95% Confidence Interval|Number
67387|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||g/dL||Standard Deviation|Mean
67388|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||pg/mL||Standard Deviation|Mean
67389|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||pg/mL||Standard Deviation|Mean
67390|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.||ng/mL||Standard Deviation|Mean
67391|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.||mg/dL||Standard Deviation|Mean
67392|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.||mEq/L||Standard Deviation|Mean
67404|NCT01134107|Other Pre-specified|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||hyperglycemic episodes per 30 days||Standard Deviation|Mean
67393|NCT01134315|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All participants||participants|||Number
67394|NCT01134315|Primary|Percentage of Participants With at Least One Incidence of Hypercalcemia|Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]).||percentage of participants|||Number
67395|NCT01134276|Secondary|Total Hospital Cost During Admission After Biliary Drainage|Total hospital cost during admission after Biliary Drainage in US dollars|during hospital stay for biliary drainage procedure|||thousands in US dollars||Standard Deviation|Mean
67396|NCT01134276|Secondary|Change in Total Serum Bilirubin After Drainage|Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)|within 14 days after drainage|||mg/dL/day||Standard Deviation|Mean
67397|NCT01134276|Primary|Incidence of Infectious Complications After Biliary Drainage|at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)|within 120 days after drainage|||participants|||Number
67398|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.||millimeters of mercury (mmHg)||Standard Deviation|Mean
67399|NCT01134107|Other Pre-specified|Change From Baseline to 12 Week Endpoint for Each Treatment in Weight||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.||kilograms (kg)||Standard Deviation|Mean
67400|NCT01134107|Other Pre-specified|Hypoglycemic Episode Rate Per 30 Days|"All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||hypoglycemic episodes per 30 days||Standard Deviation|Mean
67401|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hypoglycemic Episode|"A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).~All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||percentage of participants|||Number
67402|NCT01134107|Other Pre-specified|Pump Complications Rate Per 30 Days|Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||pump complications per 30 days||Standard Deviation|Mean
67403|NCT01134107|Other Pre-specified|Percentage of Participants With Pump Complications|Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||percentage of participants|||Number
67433|NCT01132846|Secondary|Development of Cardio-renal Syndrome||Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||participants|||Number
67434|NCT01132846|Secondary|Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio|"BUN measured in mg/dL Cystatin C measured in mg/L~No units were used in calculated the ratio"|Randomization to 72 hours|||ratio||Standard Deviation|Mean
67435|NCT01132846|Secondary|Cumulative Urinary Sodium Excretion||Randomization to 72 hours|||mmol||Standard Deviation|Mean
67405|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hyperglycemic Episode|A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||percentage of participants|||Number
67406|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.||Units (U) of insulin||Standard Deviation|Mean
67407|NCT01134107|Secondary|Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%||Endpoint for each 12-week treatment period|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.||participants|||Number
67408|NCT01134107|Secondary|Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.||percentage of HbA1c||Standard Deviation|Mean
67409|NCT01134107|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.||Units (U) of insulin||Standard Deviation|Mean
67410|NCT01134107|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D.|Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on a Day 6, or Day 2 depending on the analysis, for the respective treatment arm: insulin lispro 6D and insulin aspart 6D.||millimoles per liter (mmol/L)||Standard Deviation|Mean
67411|NCT01134107|Primary|Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use||Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)|All randomized participants who completed at least one post-randomization visit. Those included in the primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.||millimoles per liter (mmol/L)||Standard Deviation|Mean
67412|NCT01134042|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare issues were recorded.|From Baseline up to Week 24/Withdrawal Visit|ITT Population||Number of visits||Standard Deviation|Mean
67413|NCT01134042|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at Weeks 4, 12, and 24|At the end of Week 4, Week 8, and Week 24/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptoms); much less often, somewhat less often, a little less often, the same, a little more often, somewhat more often, much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
67414|NCT01134042|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Scores at Week 12 and Week 24|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12 and Week 24/Early Withdrawal minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Error|Least Squares Mean
67415|NCT01134042|Other Pre-specified|The Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 24/Early Withdrawal|ITT Population||participants|||Number
67436|NCT01132846|Secondary|Change in Treatment Response|"Treatment failure including any of the following:~development of cardio-renal syndrome~worsening/persistent heart failure~significant hypotension requiring discontinuation of study drug~significant tachycardia requiring discontinuation of study drug death"|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||participants|||Number
67416|NCT01134042|Other Pre-specified|Mean Change From Baseline in Daily Morning Trough (AM) and Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough AM/PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters/minute (L/min)||Standard Error|Least Squares Mean
67417|NCT01134042|Other Pre-specified|Change From Baseline in Weighted Mean Serial FEV1 Over 0 to 4 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 4-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.||Liters||Standard Deviation|Mean
67418|NCT01134042|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 24 clinic visit. The highest of 3 technically acceptable measurements was recorded.|Week 24|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 24 was performed.||Liters||Standard Deviation|Mean
67419|NCT01134042|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Error|Least Squares Mean
67420|NCT01134042|Secondary|Change From Baseline in the Percentage of Rescue-free and Symptom-free 24-hour Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication/symptoms was considered to be rescue free/symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of periods||Standard Error|Least Squares Mean
67421|NCT01134042|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 24 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and the post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.||Liters||Standard Error|Least Squares Mean
67437|NCT01132846|Secondary|Change in Heart Failure Status|Persistent or worsening heart failure defined as need for rescue therapy.|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||participants|||Number
67438|NCT01132846|Secondary|Dyspnea Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||units on a scale * hours||Standard Deviation|Mean
67439|NCT01132846|Secondary|Change in Serum Creatinine||randomization to 72 hours|||mg/dL||Standard Deviation|Mean
67440|NCT01132846|Secondary|Change in Clinical Stability- RED-ROSE|Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit|Baseline to 60 days|RED-ROSE was a substudy of the main ROSE trial. Only subjects consented and enrolled in RED-ROSE were included in this analysis.||participants|||Number
67422|NCT01134042|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit while still on treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline (BL) through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. BL was the pre-dose value obtained at Visit 3. Change from BL was calculated as the Week 24 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of BL trough FEV1, country, sex, age, and treatment group.The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of the study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.||Liters||Standard Error|Least Squares Mean
67423|NCT01134016|Secondary|Safety Blood and Urine Test|"Hematology laboratory data~Biochemistry laboratory data~Urinalysis~AE; AE not including the natural progress of the underlying disease~Incidence of toxicity ≥ grade 3 according to NCI CTCAE version 4.03~Physical examination~Vital signs changes~Electrocardiogram examination results (including HR, QRS, QT, QTc, RR intervals)"|pre-screenting and every 14-day period||||||
67424|NCT01134016|Secondary|Number of Participants in the PP Population With Better Than SD at Target Lesion, Better Than Non-CR/Non-PD at Non-target Lesion and no New Lesion|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for overall response by CT: Judgement by total siutation of target, non-target and new lesions.~Meaning of Target lesion: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), Sum down 30% or more from target lesion baseline; Progressive Disease(PD), Sum up at least 20% from smallest value (nadir) and Absolute increase ≥ 5 mm; Stable Disease (SD), Neither enough shrinkage for PR nor enough growth for PD.~non-target lesion: CR: All non-target lesions disappeared and All lymph nodes <10 mm; Non-CR/Non-PD: Non-target lesion(s) still present and Lymph nodes ≥10 mm; PD: Unequivocal progression; New lesion :Unequivocal new cancer lesions Overall SD response should be better than SD at target lesion, better than Non-CR/Non-PD t non-target lesion and no new lesion."|pre-screening and end of treatment|Per-protocol (PP) Population: All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST).||participants|||Number
67425|NCT01134016|Secondary|AUC0-t on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28|||log(mg*hr/mL)||95% Confidence Interval|Mean
67426|NCT01134016|Secondary|AUC0-t on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|within 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1|||log(mg*hr/mL)||95% Confidence Interval|Mean
67427|NCT01134016|Secondary|Maximum Plasma Concentration After Dosing on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28|||log(mg/ml)||95% Confidence Interval|Mean
67428|NCT01134016|Secondary|Maximum Plasma Concentration After on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1|Pharmacokinetic (PK) Population: All patients who received at least 1 dose of antroquinonol with sufficient post-dose bio-samples collected for PK profile characterization.||Log(mg/ml)||95% Confidence Interval|Mean
67429|NCT01134016|Secondary|Half-life Time From Overall Study|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28|||hours||Standard Deviation|Mean
67430|NCT01134016|Secondary|Tmax After Dose|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28|||hours||Full Range|Median
67431|NCT01134016|Primary|To Determind the Maximum Tolerable Dose for Antroquinonol|"The study design consisted of 2 phases, the accelerated titration phase and the standard titration phase.~During the accelerated titration phase, patients were enrolled in a cohort of 1 new patient for each dose level and treated for 4 weeks at that level. Any DLT or instance of MT during any 4 week treatment at any dose level led to the initiation of standard titration (3+3) phase.~If none of the first 3 patients experienced any DLT, then dose escalation proceeded for the next cohort of patients. If 1 of 3 patients developed DLT, the cohort was expanded to at most 6 patients (another 3 patients added subsequently). If exactly 1 of the 6 patients experienced DLT, then escalation to the next dose level occurred. If more than 1 patient developed DLT in any dose cohort, the dose escalation was withheld and the prior dose level was considered as the MTD unless the present dose level was level 1"|DLT is to be observed during 4 week period|Intent-to-Treat (ITT) Population: All patients who received at least 1 dose of antroquinonol.||mg|||Number
67432|NCT01132846|Secondary|Global Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better/improved|Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.||units on a scale * hours||Standard Deviation|Mean
67441|NCT01132846|Secondary|Worst Reported Symptom Changes-RED-ROSE|"To determine whether changes in worst reported symptom (WRS) (dyspnea, body swelling or fatigue) VAS (WRS-VAS) are related to the response to decongestive therapy as assessed by change in WRS VAS.~WRS range -100 to + 100 Higher number is better (improved)"|Change from Baseline to 72 hours|RED-ROSE was a substudy of the main ROSE study. Only subjects consented and enrolled in RED-ROSE were included in this analysis.||units on a scale||Standard Deviation|Mean
67442|NCT01132846|Secondary|Change in Weight|Change in weight from randomization to 72 hours. Secondary Endpoint|randomization to 72 hours|||lbs||Standard Deviation|Mean
67443|NCT01132846|Primary|Cumulative Urinary Volume|The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours|Randomization to 72 hours|||mL||Standard Deviation|Mean
67444|NCT01132846|Primary|Decongestive Changes- RED-ROSE|"To determine whether changes in pDSS or dyspnea VAS are related to the response to decongestive therapy as evidenced by fluid volume loss~Fluid volume loss is defined as cumulative urinary output minus fluid intake during the first 72 hours post randomization."|Baseline to 72 hours|RED-ROSE is a substudy of the overall ROSE study. Only consented and enrolled RED-ROSE subjects participated.||mL||Standard Deviation|Mean
67445|NCT01132846|Primary|Change in Dyspnea Assessment (RED-ROSE Substudy)|"To determine whether the pDSS is a more sensitive index of variability in dyspnea status than the dyspnea VAS assessed without standardization of conditions at assessment as assessed by change in Dyspnea VAS.~Dyspnea VAS range -100 to + 100 Larger number is better"|Baseline to 72 hours|||units on a scale||Standard Deviation|Mean
67446|NCT01132846|Primary|Change in Cystatin C|The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.|Randomization to 72 hours|||mg/L||Standard Deviation|Mean
67447|NCT01133977|Other Pre-specified|Overall Response Rate (ORR) (for Phase 2)|ORR, defined as percentage of participants with best confirmed response (complete response [CR] or partial response [PR]). A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded.|From the date of randomization until disease progression or death or up to approximately 2 years||||||
67448|NCT01133977|Other Pre-specified|Overall Survival (OS) (for Phase 2)|OS, defined as the time from the date of randomization until the date of death. Few events of deaths (9 events in the Lenvatinib + Dacarbazine arm and 4 events in the Dacarbazine arm) were reported to calculate the median OS or to draw conclusions regarding the OS.|From the date of randomization until death or up to approximately 2 years||||||
67449|NCT01133977|Other Pre-specified|Time to Progression (TTP) (for Phase 2)|TTP, defined as the time from the date of randomization until the date of progressive disease.|From the date of randomization until disease progression or death or up to approximately 2 years||||||
67450|NCT01133977|Secondary|Progression Free Survival (PFS) (for Phase 2)|PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression of such participant's disease based on Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST v. 1.1) or (2) the date of such participant's death due to any cause. Progression was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions, based on Investigator assessment according to RECIST 1.1. If missing assessments, imputed dates were used in the analysis.|From the date of randomization until the date of disease progression or death (whichever was earlier) or up to approximately 2 years|All randomized participants who received at least one dose of study drug without major protocol eligibility violations were included in the Modified Intent-to-Treat (MITT) Analysis Set.||Weeks||95% Confidence Interval|Median
67451|NCT01133977|Primary|Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)|Safety assessments consisted of monitoring and recording all AEs, including all Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0) grades, and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Details of AEs and SAEs are provided in the reported adverse event section.|From signing of informed consent up to 30 days after the last dose, up to approximately 2 years|Safety Analysis Set: All participants enrolled in the Phase 1b and Phase 2 portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.||Participants|||Number
67452|NCT01133977|Primary|Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)|DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.|From Day 1 through 21 days (one cycle)|Safety Analysis Set: All participants enrolled in the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.||Participants with DLT|||Number
67453|NCT01133860|Secondary|in Vitro Function of Platelets Produced During Therapy in Responding Patients|in vitro platelet function will be assessed in patients achieving a platelet count of 100 x10e9/L or more at the end of the therapy|21 days or 42 days of therapy|||participants|||Number
67454|NCT01133860|Secondary|All Types of Adverse Events|All type of adverse events were registered.Results indicate the number of participants who experience a side effect of the drug.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy|||number of participants|||Number
67455|NCT01133860|Secondary|Bleeding Tendency Assessed by WHO Bleeding Score|The percentage of patients with bleeding diathesis (grade 1, i.e. cutaneous bleeding, or grade 2, i.e. mild blood loss, according to WHO bleeding score) was calculated at baseline and at the end of therapy. The results are expressed as the mean change in the percentage of patients with bleeding diathesis (95%CI).|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy|||participants||95% Confidence Interval|Mean
67456|NCT01133860|Primary|Response to Drug Based on Platelet Count at the End of Therapy|The primary endpoints were the achievement of a platelet count over 100 x10e9/L or at least 3 times the baseline value (major response), or at least twice the baseline value but less than major response (minor response). The overall response to therapy is reported. Platelet count was measured at the end of therapy (21 or 42 days, see study design) by phase-contrast microscopy.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy|||percentage of participants||95% Confidence Interval|Number
67457|NCT01133756|Secondary|Biomarker-based Proportion of Biomarker-Progression-Free Survival (B-PFS) at Week 12, Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Week 12|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|||||
67458|NCT01133756|Secondary|Biomarker CA125-based Overall Response Rate (B-ORR), Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Day 1 of every cycle, at end of treatment visit and every 2 months during follow-up period for patients who complete study without progressive disease.|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|||||
67459|NCT01133756|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an intermediate dose, an additional dose cohort could be added to more accurately define the MTD.|Cycle 1 (21 days)|Safety analysis was evaluated based on Safety Population, defined as all subjects enrolled into the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessments following the first dose of study drug.||Participants|||Number
67460|NCT01133704|Secondary|Overall Survival|Subjects were followed for 3 years from the time of randomization or until death.|Time from randomization until 36 months|All randomized participants||Months||95% Confidence Interval|Median
67461|NCT01133704|Primary|Overall Time to Disease Progression|Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.|from randomization to 36 months|||Weeks||95% Confidence Interval|Median
67462|NCT01133665|Secondary|Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67463|NCT01133665|Secondary|Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67464|NCT01133665|Secondary|Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67465|NCT01133665|Secondary|Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67466|NCT01133665|Secondary|Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67467|NCT01133665|Secondary|Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67468|NCT01133665|Secondary|Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67469|NCT01133665|Secondary|Number of Participants With Back Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67470|NCT01133665|Secondary|Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67471|NCT01133665|Secondary|Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67472|NCT01133665|Secondary|Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67594|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
67477|NCT01133665|Secondary|Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67478|NCT01133665|Secondary|Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67479|NCT01133665|Secondary|Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67480|NCT01133665|Secondary|Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67481|NCT01133665|Secondary|Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67482|NCT01133665|Secondary|Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67483|NCT01133665|Secondary|Number of Participants With Headache Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67484|NCT01133665|Secondary|Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67485|NCT01133665|Secondary|Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67486|NCT01133665|Secondary|Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67487|NCT01133665|Secondary|Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67488|NCT01133665|Secondary|Number of Participants With Vomiting Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67489|NCT01133665|Secondary|Number of Participants With Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67490|NCT01133665|Secondary|Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67491|NCT01133665|Secondary|Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67492|NCT01133665|Secondary|Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67493|NCT01133665|Secondary|Number of Participants With Nausea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67494|NCT01133665|Secondary|Number of Participants With Anorexia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67495|NCT01133665|Secondary|Number of Participants With Anemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67496|NCT01133665|Secondary|Number of Participants With Constipation Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67497|NCT01133665|Secondary|Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide||participants|||Number
67499|NCT01133665|Primary|Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.|Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|24 months|||months||Full Range|Median
67500|NCT01133626|Primary|The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment|"Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome."|Day 0 (Baseline), Day 42|Per protocol population||ratio||Standard Error|Geometric Mean
67501|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in PCSK9|Serum PCSK9 concentrations were determined by using a qualified enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 15 ng/mL.|Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data||percent change||Standard Deviation|Mean
67502|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in LDL-C||Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data||percent change||Standard Deviation|Mean
67503|NCT01133522|Secondary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Evolocumab|Area under the unbound evolocumab serum concentration-time curve from time of last dose to time of last quantifiable concentration following the last dose of evolocumab.|Day 29 predose (last dose for Cohorts 3-7) and Days 36 (predose for Cohorts 1 and 2), 40, 43, 50, 57, 64, 71, 78, and 85|Pharmacokinetic analysis set with available data||day*μg/mL||Standard Deviation|Mean
67504|NCT01133522|Primary|Number of Participants With Anti-Evolocumab Antibodies|Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-evolocumab binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-evolocumab neutralizing antibodies|From the first dose of study drug until Day 85|Safety analysis set||participants|||Number
67505|NCT01133522|Secondary|Maximum Observed Plasma Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 800 ng/mL.|Day 1, predose and Days 4, 8, 15, 22, 29, 36, 40, 43, 50, 57, 64, 71, 78, and 85|The Pharmacokinetic analysis set consisted of all participants for whom at least 1 pharmacokinetic parameter or endpoint could be adequately estimated. Serum evolocumab concentrations were not detectable in Cohorts 1 and 2.||μg/mL||Standard Deviation|Mean
67506|NCT01133522|Primary|Number of Participants With Adverse Events|"The relationship of each adverse event to the investigational product was assessed by the investigator.~A serious adverse event (SAE) is defined as an adverse event that~is fatal~is life threatening (places the subject at immediate risk of death)~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~other significant medical hazard."|From the first dose of study drug until Day 85|Safety analysis set||participants|||Number
67507|NCT01133392|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.||grams (g)||Geometric Coefficient of Variation|Geometric Mean
67508|NCT01133392|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)|Time of maximal glucose infusion rate.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.||hours||Geometric Coefficient of Variation|Geometric Mean
67509|NCT01133392|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacodynamic (PD) data.||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
67510|NCT01133392|Secondary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]|The maximum observed insulin lispro concentration following dosing.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PK data.||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
67511|NCT01133392|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]|Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.|0 up to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
67512|NCT01133379|Secondary|Global Subjective VAS Score at Week 6|"At Week 6, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67530|NCT01133275|Secondary|Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment|Grade 3 or 4 events Related/Possibly Related/Probably Related to study treatment. Number of participants with events specified in the study protocol: Neutropenia, Thrombocytopenia, Febrile Neutropenia, Infection, Sepsis, Venous Thromboembolic Events. Evaluations according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.0.|Up to 54 months|All participants||participants|||Number
67513|NCT01133379|Secondary|Global Subjective VAS Score at Week 4|"At Week 4, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67514|NCT01133379|Secondary|Global Subjective VAS Score at Week 2|"At Week 2, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67515|NCT01133379|Secondary|Global Subjective VAS Score at Week 1|"At Week 1, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last week when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67516|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 6|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67517|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67518|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67519|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 1|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67531|NCT01133275|Primary|Number of Participants With Erythroid Response|The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria.|Up to 7 months|All evaluable participants||participants|||Number
67532|NCT01133171|Secondary|Change in Systolic Blood Pressure||From baseline to six months|||mmHg||Standard Deviation|Mean
67520|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 6|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67521|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67522|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67523|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 1|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||units on a scale (mm)||Standard Error|Least Squares Mean
67524|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 1|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
67525|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
67526|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
67527|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 6|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.||grams||Standard Error|Least Squares Mean
67528|NCT01133288|Secondary|Immune Response to Yulex|A secondary study outcome is the development of an immune response to Yulex using a human IgG anti-Guayule immunoassay. The development of a detectable IgG immune response will be considered a positive study.|3 months|||ug/ml|||Number
67529|NCT01133288|Primary|Sensitization to Yulex|The primary study outcome will be an assessment for sensitization to Yulex as determined by serological assay for Guayule-specific IgE antibodies. The development of a detectable IgE immune response will be considered a positive study.|Approximately 3 months|No participants were exposed to Yulex because the study was terminated.||ng/ml|||Number
67533|NCT01133171|Primary|Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk|Only the intervention patients were analyzed for this outcome.|From baseline to six-months|||percentage of patients|||Number
67534|NCT01132690|Secondary|Liver Volume|Liver volume measured by MRI|Baseline and Month 12|||mL||Standard Deviation|Mean
67540|NCT01132664|Secondary|Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll||18 months|FAS consisted of all patients who received at least 1 dose of study drug (buparlisib). PFS analysis was not done for the BM cohort population. MTD/RP2D was not established due to premature termination of the study. In the phase ll portion of the study, PFS was analyzed only in patients with known PIK3 status, thus only 26/50 patients were analyzed.||Months||90% Confidence Interval|Median
67541|NCT01132664|Secondary|Clinical Benefit Rate (CBR) - Phase l & ll|"CBR = patients with CR, PR or SD ≥ 24 weeks according to RECIST by the investigator.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = Disappearance of all tumor lesions; PR= >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).~CBR analysis was not done for the BM cohort population."||Participants|||Number
67542|NCT01132664|Secondary|Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll|"Disease control rate (DCR) = patients with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST criteria.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = disappearance of all tumor lesions; PR = >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD); PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).~CBR analysis was not done for the BM cohort population. DCR analysis was not done for the BM cohort population."||Participants|||Number
67543|NCT01132664|Primary|Overall Response Rate (ORR) - Phase ll|"Objective response rate (ORR) was defined as the rate of patients with best overall response (BOR) equal to complete response (CR) or partial response (PR) according to RECIST 1.0 from the Investigators review.~Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed of the disease status by imaging (i.e. CT/MRI): Complete Response (CR) = Disappearance of all tumor lesions; Partial Response (PR)= >=30% shrinkage of lesions; Overall Response (OR) = patients with CR and PR."|18 months|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib)||Participants|||Number
67544|NCT01132664|Primary|Dose Limiting Toxicity (DLT) - Phase l Only|Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set.|cycle 1 - 28 days|The Dose–determining set (DDS) for the determination of the MTD consisted of all patients from the safety set in the dose escalation phase who had met the minimum safety evaluation requirements and the minimum exposure criterion or had experienced DLT during Cycle 1 and were discontinued. MTD analysis was done only on the phase lb group.||Participants|||Number
67545|NCT01132651|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and at 2 weeks|||units on a scale||Inter-Quartile Range|Median
67546|NCT01132651|Primary|Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score|"The PSQI is a clinical survey used to measure sleep quality. Seven components related to sleep quality are scored: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3. A score of 0 is associated with better sleep quality and a score of 3 is associated with worse sleep quality. The seven component scores are summed to achieve a total PSQI score. The total PSQI score has a range of 0-21. A score of 0 is associated with better sleep quality and a score of 21 is associated with worse sleep quality.~Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., & Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213."|Baseline and at 2 weeks|||units on a scale||Inter-Quartile Range|Median
67547|NCT01132547|Secondary|Pattern of Weight in the Study Population|Change from Baseline in Weight|Baseline and 8 weeks|Completers||Kilograms||Standard Deviation|Mean
67548|NCT01132547|Primary|Severity of Weight Loss|Change from Baseline in Weight Z score|Baseline and 8 weeks|Completers =||Z score||Standard Deviation|Mean
67549|NCT01132547|Primary|Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline||8 weeks|LOCF||participants|||Number
67550|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 78 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67551|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 52 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67552|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 26 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67553|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 12 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67554|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 6 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67556|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 78 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67557|NCT01132508|Primary|Surgeons Overall Satisfaction With Norian Drillable|The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.|Surgery|||Cases|||Number
67558|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 52 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67559|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 26 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67560|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 12 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67561|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 6 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67562|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at Baseline|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67563|NCT01132508|Secondary|Knee Function and Stability: Extension at 78 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67564|NCT01132508|Secondary|Knee Function and Stability: Extension at 52 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67565|NCT01132508|Secondary|Knee Function and Stability: Extension at 26 Week|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67566|NCT01132508|Secondary|Knee Function and Stability: Extension at 12 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67567|NCT01132508|Secondary|Knee Function and Stability: Extension at 6 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67568|NCT01132508|Secondary|Knee Function and Stability: Extension at Baseline|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67569|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67570|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67571|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67572|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67573|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67574|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Surgery|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67575|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Baseline|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67576|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 78 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67577|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 52 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67578|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 26 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67579|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 12 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67580|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 6 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67581|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Surgery|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67595|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
67582|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Baseline|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67583|NCT01132508|Secondary|Radiographic Parameters: Depression at 78 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67584|NCT01132508|Secondary|Radiographic Parameters:: Depression at 52 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67585|NCT01132508|Secondary|Radiographic Parameters: Depression at 26 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67586|NCT01132508|Secondary|Radiographic Parameters: Depression at 12 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67587|NCT01132508|Secondary|Radiographic Parameters: Depression at 6 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 week|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67588|NCT01132508|Secondary|Radiographic Parameters: Depression at Surgery|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67589|NCT01132508|Secondary|Radiographic Parameters: Depression at Baseline|"The anatomical grading parameter depression was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.||participants|||Number
67590|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
67591|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
67592|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
67593|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
67596|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Tap|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.~A tap is an instrument used to create threads in a hole drilled in bone."|Day 0 (Date of surgery)|||Cases|||Number
67597|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: K-wire|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.~Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures."|Day 0 (Date of surgery)|||Cases|||Number
67598|NCT01132508|Secondary|Pain and Function Assessed With the Lysholm Knee Scale|The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.|6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)|Five major protocol violations were excluded in the efficacy analysis.||units on a scale||Full Range|Median
67599|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Drill|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)|||Cases|||Number
67600|NCT01132508|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device||At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative|||participants|||Number
67601|NCT01132508|Primary|Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)|Day 0 (Day of surgery)|||Cubic Centimeters||Standard Deviation|Mean
67602|NCT01132508|Primary|Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)|Day 0 (Day of surgery)|||Minutes||Full Range|Median
67603|NCT01132495|Secondary|Overall MACE|Non-urgent revascularization procedures, cost and cost effectiveness, functional class, number of anti-anginal medication, rate of non-urgent revascularization, and rate of cerebrovascular event.|5 years||03/2018||||
67604|NCT01132495|Primary|Major Adverse Cardiac Event Rate (MACE)|MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.|24 Month|The primary outcome analysis was designed for Cohort A only.||percentage of subjects with SAEs|||Number
67605|NCT01132378|Secondary|Quadriceps Strength||2 year||||||
67606|NCT01132378|Primary|Knee Society Score|The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain|2 year|||score||Standard Deviation|Mean
67607|NCT01132326|Primary|Patients With Treatment-emergent Adverse Events|Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study|up to 2 years|||participants|||Number
67608|NCT01132313|Secondary|Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment|Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment|up to 28 weeks|FAS||Percentage of participants||95% Confidence Interval|Number
67609|NCT01132313|Secondary|Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment|Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment|Week 4 and 12|FAS||Percentage of participants|||Number
67610|NCT01132313|Secondary|Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment|Part 2: Sustained virological response at 4 and 24 weeks after end of treatment|4 weeks and 24 weeks after the end of treatment, up to 64 weeks|FAS||Percentage of participants|||Number
67611|NCT01132313|Secondary|Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4|Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4|4 weeks|FAS||Percentage of participants|||Number
67612|NCT01132313|Secondary|Part 2: Time to Virological Response|Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 40 weeks|FAS||Percentage of participants|||Number
67613|NCT01132313|Secondary|Part 1: Time to Virological Response|Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 4 weeks|FAS||Percentage of participants|||Number
67614|NCT01132313|Primary|Part 3 and 4: Sustained Virological Response (SVR)|Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 36 weeks|FAS||Percentage of participants||95% Confidence Interval|Number
67615|NCT01132313|Primary|Part 2: Sustained Virological Response (SVR)|Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 52 weeks|FAS||Percentage of participants|||Number
67616|NCT01132313|Primary|Part 1: Rapid Virological Response (RVR)|Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment|4 weeks|FAS which included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
67617|NCT01132144|Secondary|Procedure Related Pain|"Pain will be assessed using a Visual Analogue Scale (VAS). We will use a 10 cm length horizontal line, anchored by word descriptors at each end: No Pain = 0 cm and Very Severe Pain = 10 cm.~This outcome will be assessed in both groups, just after endometrial injury or sham procedure."|Immediately after procedure|All women enrolled.||cm||Standard Deviation|Mean
67618|NCT01132144|Secondary|Three-dimensional Doppler Indices From Endometrium (VFI)|"Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) assessed from endometrium using three-dimensional Power Doppler ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.~Only VFI was reported as it is a combination of VI and FI (VFI = VI*FI/100), and currently there are several concerns about the validity of these indices.~Such indices have no scale."|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.||index||Standard Deviation|Mean
67619|NCT01132144|Secondary|Endometrial Volume|The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.||cm³||Standard Deviation|Mean
67620|NCT01132144|Secondary|Endometrial Thickness|The maximum distance perpendicular to the inter-endometrial interface from the endometrium-myometrium interface of the anterior to the posterior wall of the uterus assessed in the sagittal plane. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.||mm||Standard Deviation|Mean
67621|NCT01132144|Secondary|Implantation Rate|The number of gestational sacs observed divided by the number of embryos transferred.|3 months||||||
67622|NCT01132144|Secondary|Miscarriage|"Loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization).~Note: All allocated women will be considered when assessing miscarriage rate."|9 months|The number of clinical pregnancies was used as denominator, since miscarriage is a harm that can only happen in pregnant women.||Clinical pregnancies|||Number
67623|NCT01132144|Secondary|Ongoing Pregnancy|"At least one fetus with heart beat after 12 weeks of gestational age.~Note: All allocated women will be considered when assessing ongoing pregnancy rate."|6 months|||participants|||Number
67624|NCT01132144|Secondary|Clinical Pregnancy|"Pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.~Note: All allocated women will be considered when assessing clinical pregnancy rate."|3 months|All women enrolled.||participants|||Number
67625|NCT01132144|Primary|Live Birth|"The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.~Note: All allocated women will be used as denominator when assessing live birth rate."|1 year|All women enrolled.||participants|||Number
67626|NCT01132118|Secondary|Triglycerides|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
67627|NCT01132118|Secondary|HDL Cholesterol|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
67628|NCT01132118|Secondary|LDL Cholesterol|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
67629|NCT01132118|Secondary|Total Cholesterol|mg/dL|Baseline and Week 8|||mg/dL||Standard Deviation|Mean
67630|NCT01132118|Secondary|HOMA-B|HOMA-B = (360 x Insulin)/(Glucose - 63)|Baseline and Week 8|||(mIU x dL)/(L x mg)||Standard Deviation|Mean
67631|NCT01132118|Secondary|HOMA-IR|"We will examine the effect of HCQ on HOMA-IR during the active treatment phase compared with placebo phase.~HOMA-IR = (Glucose x insulin)/405"|Baseline and Week 8|||(mg x mIU)/(dL*L)||Standard Deviation|Mean
67632|NCT01132118|Primary|Insulin Sensitivity Index|"We will examine the effect of HCQ on the Matsuda Insulin Sensitivity Index (ISI) during the active treatment phase compared with placebo phase.~ISI is based on insulin and glucose levels in a fasting state during an oral glucose tolerance test (OGTT) and is calculated as follows:~ISI (Matsuda) = 10000/√ G0 X I0 X Gmean X Imean~G0 - fasting plasma glucose (mg/dL) I0 - fasting plasma insulin (mIU/L) Gmean - mean plasma glucose during OGTT (mg/dL) Imean - mean plasma insulin during OGTT (mIU/L)"|Baseline and Week 8|||(dL x L)/(mg x mIU)||Standard Deviation|Mean
67633|NCT01131884|Primary|Bone Mineral Density|Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis|1 year after enrollment|No analysis performed as there was only one patient who participated in this study|||||
67634|NCT01131676|Secondary|Percentage of Participants With the Composite Microvascular Outcome|"Composite microvascular outcome defined as:~Initiation of retinal photocoagulation~Vitreous haemorrhage~Diabetes-related blindness, or~New or worsening nephropathy defined as:~New onset of macroalbuminuria; or~Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or~Initiation of continuous renal replacement therapy, or~Death due to renal disease. Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
67635|NCT01131676|Secondary|Percentage of Participants With New Onset Macroalbuminuria|New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
67636|NCT01131676|Secondary|Percentage of Participants With New Onset Albuminuria|"New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
67637|NCT01131676|Secondary|Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)|Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS||percentage of participants|||Number
67664|NCT01131078|Primary|Time to Progression (TTP)|TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only those participants with an event of disease progression or death were included in the analysis||months||95% Confidence Interval|Median
67638|NCT01131676|Secondary|Percentage of Participants With Silent MI|"Silent MI; defined as presence in the ECG of:~Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3~Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF)~R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect.~It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)||percentage of participants|||Number
67639|NCT01131676|Secondary|Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris|"The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS||percentage of participants|||Number
67640|NCT01131676|Primary|Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.|"Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS||percentage of participants|||Number
67641|NCT01131585|Primary|Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12|Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant’s refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.|12 months|Full Analysis Set consisted of all participants who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. No patient completed the 12 months observational period due to study early termination; therefore, the last observation carried forward (LOCF) method was used with data from 11.1 months.||Letters||Standard Deviation|Mean
67642|NCT01131507|Secondary|Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12|Participant’s ability to thrive was evaluated through growth percentiles for weight-for-age, length-for-age and weight-for-length recorded on Center for Disease Control and Prevention (CDC) growth charts during each treatment visit.|Baseline, Month 3, 6, 9 and 12|Safety population included all participants who received at least 1 dose of study drug. Here, 'n' specifies number of participants who were evaluable for various categories at each time point.||percentile||Full Range|Median
67643|NCT01131507|Primary|Frequency and Severity of Treatment-emergent Adverse Events (TEAEs)|TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE’s relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild [minimal/no treatment and did not interfere with daily activities], moderate [resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning] and severe [interrupted participant’s usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating]) with a frequency threshold of above 5% were reported.|Up to Month 12 or early termination|Safety population included all participants who received at least 1 dose of study drug.||participants|||Number
67644|NCT01131494|Primary|Oropharyngeal Swallowing Score|Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.|five weeks|||Scores on a scale||Standard Deviation|Mean
67645|NCT01131494|Secondary|Quality of Life|Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.|five weeks|||scores in a scale||Inter-Quartile Range|Median
67646|NCT01131455|Primary|CT Scan for Fusion Analysis|There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.|8 weeks post op.||||||
67647|NCT01131299|Secondary|Lipoprotein Insulin Resistance Index (LIRI) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|LIRI was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|The LIRI score is a composite of six lipoprotein parameters (VLDL, HDL and LDL, and concentrations of large VLDL, large HDL and small LDL subclasses) measured by NMR spectroscopy, which may be apparent years before the onset of overt hyperglycemia. LIRI scores range from zero, the most insulin sensitive, to 100, the most insulin resistant.||percentage||Standard Error|Mean
67648|NCT01131299|Secondary|Serum Glucose Levels After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Serum glucose levels was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|||mg/dL||Standard Error|Mean
67705|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS||mg||Standard Deviation|Mean
67649|NCT01131299|Secondary|Small LDL Particle Number (by NMR Spectrometry of Lipoproteins) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Small LDL particle numbers were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|||nmol/L||Standard Error|Mean
67650|NCT01131299|Primary|Total Serum Cholesterol Levels for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Total cholesterol levels were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|||mg/dL||Standard Error|Mean
67651|NCT01131182|Secondary|Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.||Proportion of participants|||Number
67652|NCT01131182|Primary|Proportion of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.||proportion of participants|||Number
67653|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Air Optix Aqua|Lens wettability was assessed at each visit as Grade 4 – 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes||eyes|Participants||Number
67654|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Acuvue Oasys|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible, dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
67655|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible dispensed eyes||units on a scale|Participants|Standard Deviation|Least Squares Mean
67656|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Acuvue Oasys|Lens wettability was assessed at each visit as Grade 4 – 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes||eyes|Participants||Number
67657|NCT01131078|Secondary|Duration of Overall Complete Response|Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years|ITT Population; Only participants with a best overall response were included in the analysis.||months||95% Confidence Interval|Median
67658|NCT01131078|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.||months||95% Confidence Interval|Median
67659|NCT01131078|Secondary|Duration of Overall Response|Duration of overall response included participants who achieved a CR or PR.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
67660|NCT01131078|Secondary|Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment|Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.|Randomization, Weeks 3, 6 and 9, and 12|ITT Population; All participants with evaluable data were included in the analysis.||percentage of participants||95% Confidence Interval|Number
67661|NCT01131078|Secondary|Percentage of Participants With Stable Disease|Stable disease rate was the proportion of participants who achieved CR, PR, or SD.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis||percentage of participants||95% Confidence Interval|Number
67662|NCT01131078|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis||percentage of participants||95% Confidence Interval|Number
67663|NCT01131078|Secondary|Percentage of Participants by Best Overall Response|Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis||percentage of participants|||Number
67706|NCT01130844|Primary|CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS||L/h||Standard Deviation|Mean
67665|NCT01131078|Secondary|Time to Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.||months||95% Confidence Interval|Median
67666|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
67667|NCT01131078|Secondary|Time to Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.||months||95% Confidence Interval|Median
67668|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
67669|NCT01131078|Secondary|Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a treatment failure event were included in the analysis.||months||95% Confidence Interval|Median
67670|NCT01131078|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
67671|NCT01131078|Secondary|Overall Survival|Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with an event (death) were included in the analysis.||months||95% Confidence Interval|Median
67672|NCT01131078|Secondary|Percentage of Participants Who Died|Overall survival is defined as the time from date of randomization until death from any cause|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population||percentage of participants|||Number
67673|NCT01131078|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population;||percentage of participants|||Number
67674|NCT01131065|Secondary|Safety and Tolerance|Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.|During and after each product administration (during the 12 month treatment period)|||participants|||Number
67675|NCT01131065|Primary|HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)||Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12|||IU/L||Standard Deviation|Mean
67676|NCT01131065|Primary|HBV Recurrence|HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity|First six and twelve months after liver transplantation|||participants|||Number
67677|NCT01131052|Primary|Mean of Weekly Fasting Blood Glucose Concentration|Mean weekly blood glucose concentration at 3 months|3 months|||mg/dL||Standard Deviation|Mean
67678|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|6 months|||percent of glycosylated hemoglobin||Standard Deviation|Mean
67679|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|3 months|||percent of glycosylated hemoglobin||Standard Deviation|Mean
67680|NCT01131052|Secondary|Mean of Daily Blood Glucose Concentration|Mean of daily blood glucose concentration at baseline|Baseline|||mg/dL||Standard Deviation|Mean
67681|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|Baseline|||percent of glycosylated hemoglobin||Standard Deviation|Mean
67682|NCT01131052|Secondary|Mean Blood Glucose Concentration|Mean blood glucose concentration at baseline|Baseline|||mg/dL||Standard Deviation|Mean
67683|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL|Mean weekly blood glucose concentration less than 40 mg/dL at 3 months|3 months|||percentage of participants|||Number
67684|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL|Mean weekly blood glucose concentration less than 70 mg/dL at 3 months|3 months|||percentage of participants|||Number
67685|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|2 week and 1 month follow-up|All eligible, dispensed eyes||logMAR|Participants|Standard Deviation|Mean
67686|NCT01130974|Secondary|Symptoms & Complaints|Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.|Summarized over all follow-up visits through one month|All eligible dispensed eyes, summarized over all follow-up visits through 1 month.||units on a scale|Participants|Standard Deviation|Mean
67707|NCT01130844|Primary|Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS||hours||Full Range|Median
67687|NCT01130974|Secondary|Lens Movement|Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
67688|NCT01130974|Secondary|Lens Centration|"Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).~Suboptimal lens centration was defined as a rating other than excellent."|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
67689|NCT01130974|Secondary|Lens Deposits|Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
67690|NCT01130974|Secondary|Lens Wettability|Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.||eyes|Participants||Number
67691|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|Summarized over all visits, and dispensed visit|All eligible, dispensed eyes||logMAR|Participants|Standard Deviation|Mean
67692|NCT01130974|Primary|Slit Lamp Findings|Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe|Summarized over all follow-up visits through 1 month|All dispensed eyes with any slit lamp findings > grade 2||eyes|Participants||Number
67693|NCT01130883|Secondary|Termination of Treatment Due to Noncompliance|Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.|Day 8 - 16|A total of 3128 participants were included in the analysis.||Participants|||Number
67694|NCT01130883|Secondary|Compliance|Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.|Day 8 - 16|||Participants|||Number
67695|NCT01130883|Secondary|Study Drug Given as the First, Second or Third Antimicrobial Treatment|Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.|Day 0|||Participants|||Number
67696|NCT01130883|Secondary|Chest X-ray in Case of Community-Acquired Pneumonia (CAP)|Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.|Day 0|Chest X-ray was performed in 294 of the participants for whom the physician suspected pneumonia.||Participants|||Number
67697|NCT01130883|Secondary|Auscultation|Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, auscultation findings were not reported for 38 participants at the initial visit and 116 participants at the final visit.||Participants|||Number
67698|NCT01130883|Secondary|Dyspnea and Its Type|Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).|Day 0, Day 8-16|||Participants|||Number
67699|NCT01130883|Secondary|Cough and Its Character|Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)|Day 0, Day 8-16|||Participants|||Number
67700|NCT01130883|Secondary|Bacteriological Investigation (if Available)|The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.|Day 0|Of the 3128 participants included in the analysis, 225 participants had bacteriological investigations conducted at the Initial visit (Day 0). Some participants had more than one finding.||participants|||Number
67701|NCT01130883|Secondary|Body Temperature|Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, body temperature was not reported for 6 participants at the Initial visit, and 14 participants at the Second visit.||Participants|||Number
67702|NCT01130883|Primary|Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)|Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. “Regression of chest X-ray findings” were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).|Day 0, Day 8 - 16|||participants|||Number
67703|NCT01130883|Primary|Disappearance or Significant Alleviation of Symptoms|"Overall therapeutic response, yes or no was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response."|Day 8 - 16|A total of 3130 participants were enrolled into the study and 3128 were included in the analysis. Two participants were excluded from the analysis as they did not meet entry criteria (2 participants were less than 18 years of age).||Participants|||Number
67704|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS||mg||Standard Deviation|Mean
67712|NCT01130844|Primary|Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over a 24-hour period starting on day 7|PKS||ug/L||Standard Deviation|Mean
67713|NCT01130844|Secondary|Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State|The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + [0.7847* Xu0-24h Ac-5-ASA])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours.|Over a 24-hour period starting on day 7|PKS||percentage of dose absorbed||Standard Deviation|Mean
67714|NCT01130844|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|The Pharmacokinetic Set (PKS) consisted of all subjects in the Safety Analysis Set who generated sufficient plasma samples to allow reliable determination of Cmax and AUC. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||ug*h/L||Standard Deviation|Mean
67715|NCT01130831|Secondary|Number of Tablets Per Day||12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior||Number of Tablets||Standard Deviation|Mean
67716|NCT01130831|Secondary|Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||mg||Standard Deviation|Mean
67717|NCT01130831|Secondary|Change From Baseline in Vitamin D Dose at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||ng||Standard Deviation|Mean
67718|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate|Hypercalcemia defined as total serum calcium above 11.22 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67719|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy|Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67720|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67721|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67722|NCT01130831|Secondary|Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=38) for this outcome which does not allow for any meaningful comparison.||percent change in vitamin D||Standard Deviation|Mean
67723|NCT01130831|Secondary|Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=36) for this outcome which does not allow for any meaningful comparison.||percent change in vitamin D||Standard Deviation|Mean
67724|NCT01130831|Secondary|Percent Change From Baseline in iPTH Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in iPTH levels||Standard Deviation|Mean
67725|NCT01130831|Secondary|Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in calcium-phosphorous||Standard Deviation|Mean
67726|NCT01130831|Secondary|Percent Change From Baseline in Calcium Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in calcium levels||Standard Deviation|Mean
67727|NCT01130831|Secondary|Percent Change From Baseline in Phosphorous Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percent change in phosphorous levels||Standard Deviation|Mean
67728|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy|iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67729|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
67730|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67731|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67732|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects|||Number
67733|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
67734|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
67735|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
67736|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
67737|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.||percentage of subjects||95% Confidence Interval|Number
67738|NCT01130740|Secondary|PHQ-8|This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.|12-months|||units on a scale||Standard Error|Mean
67739|NCT01130740|Secondary|Short Physical Performance Test Protocol|"This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance).~The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months|||units on a scale||Standard Error|Mean
67740|NCT01130740|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from none (0) to severe / extreme (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months|All enrolled participants were analyzed, on an intent to treat basis. One enrolled participants in the Usual Care grouped changed clinical care to an enrolled OA Intervention provider after randomization, so that participant was analyzed with the OA intervention group.||units on a scale||Standard Error|Mean
67741|NCT01130597|Secondary|Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline||Baseline and Day 56|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 8||mg/g||Standard Error|Mean
67742|NCT01130597|Secondary|Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline||Baseline and Day 28|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 4||mg/g||Standard Error|Mean
67760|NCT01130532|Secondary|"Change From Week 12 to Week 16 Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 3"|"Assessed the percentage of Yes responses to the SEP diary Question 3 Did your erection last long enough for you to have successful intercourse? from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment)."|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||"percentage of yes responses"||Standard Deviation|Mean
67761|NCT01130532|Secondary|Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Deviation|Mean
67762|NCT01130532|Secondary|Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).|12 weeks through 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||percentage of participants|||Number
67763|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) – Partner Satisfaction With Medication Score at Week 12 Endpoint|The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67764|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner|The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67765|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)|Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67766|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint|The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67774|NCT01130337|Secondary|Percentage of Participants With Complete Tumor Resection (R0)|R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|"ITT population. Here number of participants analyzed included those who underwent surgery."||percentage of participants||95% Confidence Interval|Number
67812|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine sodium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(mmol/day)||Standard Deviation|Mean
67767|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient|The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67768|NCT01130532|Secondary|"Change From Baseline to 12-Week in Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 1-5"|Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||"percentage of yes responses"||Standard Error|Least Squares Mean
67769|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score|Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67770|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67771|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||units on a scale||Standard Error|Least Squares Mean
67772|NCT01130532|Primary|Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).|Baseline through 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."||percentage of participants|||Number
67773|NCT01130337|Secondary|Percentage of Participants With Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.||percentage of participants|||Number
72123|NCT01083771|Primary|Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet|Based on overall percentage change at baseline versus post diet|eight weeks|||percentage of change||Standard Deviation|Mean
67775|NCT01130337|Secondary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.||percentage of participants||95% Confidence Interval|Number
67776|NCT01130337|Primary|Percentage of Participants With Disease-free Survival (DFS) at Month 18|DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).|Month 18|ITT population.||percentage of participants||95% Confidence Interval|Number
67777|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67778|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment|Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67779|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67780|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67781|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment|Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose DBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67782|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment|Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose DBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67783|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment|Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose SBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67784|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment|Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose SBP analysis."||mm mercury (Hg)||Standard Deviation|Least Squares Mean
67785|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for two participants in the ISM ER treatment group, therefore these participants were excluded from the multiple dose AIx analysis."||percent||Standard Deviation|Least Squares Mean
67786|NCT01130168|Primary|Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose AIx analysis."||percent||Standard Deviation|Least Squares Mean
67787|NCT01130103|Primary|Number of Participants Who Met Remission Criterion|remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1|Weeks 5,10|all participants who were randomized, with people who dropped out counted as non-remitters||participants|||Number
67788|NCT01130103|Secondary|Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10|Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life|weeks 0,5,10|observed data at weeks 0, 5, and 10||units on a scale||Standard Deviation|Mean
67789|NCT01130103|Secondary|Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms|total score at weeks 0, 5, 10|weeks 0,5,10|observed data at each time point||units on a scale||Standard Deviation|Mean
67790|NCT01130103|Secondary|Treatment Response at Weeks 5 and 10|"responder status: CGI-change score of 1 or 2~1=very much improved, 2= much improved"|weeks 5,10|all subjects randomized with dropouts carried forward as nonresponders||participants|||Number
67791|NCT01130103|Primary|Clinician Administered PTSD Scale (CAPS)|PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD|Weeks 0,5,10|all participants who were randomized||units on a scale||Standard Deviation|Mean
67792|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.||ng-hr/mL||Standard Deviation|Mean
67793|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.||ng-hr/mL||Standard Deviation|Mean
67794|NCT01130051|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.||ng/mL||Standard Deviation|Mean
67795|NCT01129960|Primary|Change From Baseline to Endpoint in Mean Pain|Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. Primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [“0” = no pain; “10” = the most intense pain imaginable]|baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)|FAS = Full Analysis Set (comprised all randomized subjects with mean pain score at baseline and mean score after randomization; subjects with less than 20 days of study medication of the cut-off date were excluded from the dataset, except those that prematurely withdrew; this was the primary population used in the efficacy analysis)||units on a scale||Standard Error|Least Squares Mean
67796|NCT01129921|Primary|Visual Analog Scale (VAS) Mean Improvement|VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.|Baseline and Year 1|All patients who reported Year-1 outcomes (Year-1 Cohort) were analyzed. The Sham Year-1 cohort represent those original Sham patients who crossed over from Sham to the mild procedure and were then followed for one year.||units on a scale||Standard Deviation|Mean
67797|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|"VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the moderate to severe categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below."|Week 6 to 12 & Year One After Sham to mild x-over|Patients who reported Year 1 outcomes are reported at Week 6-12 and at Year 1. All findings reported below for the Sham group are after cross-over to mild.||participants|||Number
67798|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a “mild” pain score of 1-3 points and a “moderate to severe” pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.|Week 6 to 12 prior to cross-over|All 40 participants (20 in each arm) reported VAS at six weeks to twelve weeks post-treatment. All measurements for the sham group occurred prior to cross-over to the mild procedure. Patients with scores of 4 or less in each study group are reported below. This is Intent to Treat (ITT)analysis.||participants|||Number
67799|NCT01129765|Secondary|Number of Patients Experiencing a Physical Injury During Use|"After the procedure, the patient was directly examined for any of the following:~bleeding from the nostrils~disruption of the skin around the nose~increased work of breathing/respiratory distress (increased respiratory rate, increased respiratory accessory muscle use)"|Day one, immediately|This is the total number of participants, all of whose children were examined after the procedure.||paricipants|||Number
67800|NCT01129765|Secondary|Number of Patients Who Were Observed to Have an Adverse Event|"While using the device, the patients were observed by the research coordinator for any of the following adverse events to occur:~bloody nose~being sprayed in the eye with the saline~vomiting after the procedure~choking during or after the procedure~other"|Day one, immediately|||patients with an adverse event|||Number
67801|NCT01129765|Secondary|Number of Participants Who Identified the Device's User Manual as Easy to Understand|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.~The question and scale are as follows: How easy was the manual to understand?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|||participants|||Number
67802|NCT01129765|Primary|Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device|"'Proper use' is defined as successfully completing all of the following five steps:~Attaching wash-head to handle properly~Positioning child correctly for procedure as per the user manual's instructions~Using the device's control button correctly for both irrigation and aspiration~Placing the wash-head tip correctly at the nasal opening~Using the device for up to but not exceeding five seconds"|Day one, immediately|||participants|||Number
67803|NCT01129765|Secondary|Number of Participants Who Found the Device to be Effective|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.~The question and scale are as follows: How well did the device remove nasal secretions?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|||participants|||Number
67804|NCT01129765|Secondary|Number of Participants Who Experienced Ease of Use With the Device|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. An answer of 3 or greater is considered an affirmative answer. Such responses reported along with the exact 95% confidence intervals.~The question and scale are as follows: How easy was the device to use?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|This was the total number of participants who answered this question.||participants|||Number
67805|NCT01129622|Secondary|Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole|The number of participants who developed short term hypoestrogenic side effects or other adverse effects of letrozole during the intake of the medication or in the following week.|Three days plus One Week following medication|All entered subjects||Number of participants|||Number
67806|NCT01129622|Primary|Number of Women With Reduced Breast Parenchymal Enhancement|Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc − SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.|One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement|All participants who completed two MRIs were analysed. Percentage reduction in breast enhancement compared to baseline was determined.||Number of participants|||Number
67807|NCT01129583|Secondary|Broberg Morrey Composite Elbow Function Score|Composite elbow function store that takes into account range of motion, stability, strength, and pain. Score ranges from 0 (worse possible function) to 100 (best possible function).|6 months post-op|||Score||Standard Error|Mean
67808|NCT01129583|Secondary|Elbow Range of Motion|Elbow flexion/extension active range of motion was assessed with the use of a standard goniometer with the center placed over the lateral epicondyle and the arms aligned with the long axis of the humerus and ulna, respectively. Full extension (arm completely straight) is defined as 0 degrees, and peak flexion is measured as the angle formed by the arm and forearm compared to a full straight arm.|3 months post-op|||Degrees||Standard Error|Mean
67809|NCT01129583|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb.~The DASH is scored in two components: the disability/symptom questions (30 items, scored 1-5) and the optional high performance sport/music or work section (4 items, scored 1-5). The DASH disability/symptom score (0-100) is calculated by averaging all the scores, subtracting one and multiplying by 25. A score of 0 represents no disability, while 100 represents maximum possible disability."|1 year post-op|||Scores on a Scale (0-100)||Standard Error|Mean
67810|NCT01129557|Secondary|Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(ng/dL)||Standard Deviation|Mean
67811|NCT01129557|Secondary|Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(ug/day)||Standard Deviation|Mean
67813|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine protein for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(mg/day)||Standard Deviation|Mean
67814|NCT01129557|Secondary|Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum potassium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||(mmol/L)||Standard Deviation|Mean
67815|NCT01129557|Secondary|Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum creatinine for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||mg/dL||Standard Deviation|Mean
67816|NCT01129557|Secondary|Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) blood pressure for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)|||mm Hg||Standard Deviation|Mean
67817|NCT01129557|Secondary|Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean 24-hour urine sodium (mmol/day) at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months|||mmol/day||Standard Deviation|Mean
67818|NCT01129557|Secondary|Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum potassium at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months|||mmol/L||Standard Deviation|Mean
67819|NCT01129557|Secondary|Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean urine aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months|||ug/day||Standard Deviation|Mean
67820|NCT01129557|Secondary|Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months|||ng/dL||Standard Deviation|Mean
67821|NCT01129557|Primary|Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.|The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.|9 months|||participants|||Number
67822|NCT01129531|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia|Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||Score on a scale||Standard Deviation|Mean
67823|NCT01129531|Secondary|Change From Baseline in Area of Allodynia|A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||cm^2||Standard Deviation|Mean
67824|NCT01129531|Secondary|Change From Baseline in Area of Spontaneous Pain|A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||cm^2||Standard Deviation|Mean
67825|NCT01129531|Primary|Change From Baseline in the Average Pain Intensity Score at Week 12|Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.||Score on a scale||Standard Deviation|Mean
67826|NCT01129336|Secondary|Change From Baseline in Urine NTX by Month|NTX= N-telopeptide of type 1 collagen (nmol bce/mmol [nanomoles of bone collagen equivalents per millimole of creatinine]). Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or visit 2 value for patients who did not receive study drug.|Baseline, Month 2, Month 4|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.||nmol bce/mmol||Standard Deviation|Mean
67827|NCT01129336|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from the date of enrollment to the date of first documented disease progression or death due to metastatic breast cancer.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.||Days||95% Confidence Interval|Median
67828|NCT01129336|Secondary|Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month|Circulating tumor cells (CTCs) have been associated with poor patient prognosis and outcomes in patients receiving treatment for MBC. CTCs have been evaluated as a potential biomarker for predicting treatment effects and overall survival. Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or Visit 2 value for patients who did not receive the study drug. Percentage was calculated as the number of patients with CTC ≥5/7.5 mL against the number of patients with nonmissing CTC values (represented as 'n' in the categories).|Baseline, Month 1, 2, 4, 6, 9 and 18|"All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug. n in each category represents the number of patients with non-missing CTC values."||Percentage of Participants||95% Confidence Interval|Number
68027|NCT01127607|Secondary|ADHD Severity Clinical Global Impressions Severity Subscale|clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
67829|NCT01129336|Primary|Number of Participants With Progression Free Survival (PFS)|Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.||Participants|||Number
67830|NCT01129284|Secondary|Sustained Remissions up to 1 Year After Discontinuing Therapy|Complete remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at last follow-up visit (6 to 12 months post treatment). Partial remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at last follow-up visit (6 to 12 months post treatment).|Up to 1 year after treatment|||participants|||Number
67831|NCT01129284|Primary|Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)|Complete remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at month 6. Partial remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at month 6.|6 months|||participants|||Number
67832|NCT01129245|Secondary|Change in Luteal Phase Progesterone Levels|progesterone levels during study|completion of study (1 year)||||||
67833|NCT01129245|Primary|Menstrual Length When Taken After Ovulation: Extended Luteal Phase|average menstrual cycle length in days during active drug exposure|Completion of study (1 year)|||days||Standard Deviation|Mean
67834|NCT01129206|Secondary|Correlation of FDG PET Response With Response Rate|Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.|Approximately three years|2 patients not evaluable for response applying the PERCIST criteria per PET||patients|||Number
67835|NCT01129206|Secondary|Overall Survival (OS)|OS was determined from the date of start of therapy to death frm any cause.|Approximately five years|||months||95% Confidence Interval|Median
67836|NCT01129206|Secondary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Approximately three years|||months||95% Confidence Interval|Median
67837|NCT01129206|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Approximately three years|||patients|||Number
67838|NCT01129141|Primary|Tinnitus Functional Index|The TFI served as the primary outcome measure. The TFI is a 25-item self-report questionnaire that has documented validity both for scaling the severity and negative impact of tinnitus, and for measuring treatment-related changes in tinnitus (responsiveness) (Meikle et al., 2012). The total score for the TFI ranges from 0 to 100, with higher scores indicating greater problems with tinnitus. The TFI has excellent internal consistency (Cronbach’s α = .97) and high test-retest reliability (r = .86) (Meikle et al., 2012). The authors of the TFI estimated that a 13-point decrease on the TFI for an individual is likely to reflect a change that feels meaningful to the person.|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
67839|NCT01129128|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared|1- 30 days after starting study medication|Participants who received at least one dose of study medication||participants|||Number
67840|NCT01129128|Secondary|Peak Level IL-2|Highest level of IL-2 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
67841|NCT01129128|Secondary|Peak Level Interferon Gamma|Highest level of Interferon gamma while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
67842|NCT01129128|Secondary|Peak Level IL-6|Highest level of IL-6 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
67843|NCT01129128|Primary|Peak Level of TNF Alpha|Highest level of TNF alpha while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.||pg/ml||Standard Deviation|Mean
67844|NCT01129115|Primary|Change in Physical Performance Test|The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.|26 Week|||units on a scale||Standard Deviation|Mean
67845|NCT01129115|Primary|Change in Maximal Oxygen Consumption|Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness|26 weeks|||ml/kg/min||Standard Deviation|Mean
68674|NCT01121666|Secondary|Number of Patients With Good Response|"Good response was defined as patients with an oocyte retrieval of four or more oocytes"|Until child birth/miscarriage, up to the end of the study|Intention to treat population.||Participants|||Number
67846|NCT01129115|Secondary|Reasoning|"Reasoning is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests:Letter and Word Inductive Reasoning, Matrix Reasoning.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks|||units on a scale||Standard Error|Mean
67847|NCT01129115|Secondary|Set Maintenance & Shifting|"Set Maintenance and Switching is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: DKEFS Card Sort, Animal and Vegetable Category Fluency.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks|||units on a scale||Standard Error|Mean
67848|NCT01129115|Secondary|Simple Attention|"Simple Attention is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Digit span Forward and Backward, Letter Numbers Sequencing.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks|||units on a scale||Standard Error|Mean
67849|NCT01129115|Primary|Visuospatial Processing|"Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 weeks|||units on a scale||Standard Error|Mean
67850|NCT01129115|Secondary|Verbal Memory|"Verbal Memory is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Logical Memory, Delayed Logical Memory, Selective Reminding Task - Free Recall Total, Boston Naming Test.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance.Negative numbers indicate worsening performance."|26 weeks|Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels.||units on a standardized scale||Standard Error|Mean
67851|NCT01129102|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks|This analysis was carried out based on FAS population. IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available in IKH-01 group.||units on a scale||Standard Deviation|Mean
67852|NCT01129102|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea.||units on a scale||Standard Deviation|Mean
67853|NCT01129011|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
67854|NCT01129011|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
67855|NCT01129011|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|Baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
67856|NCT01129011|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat Population||Participants|||Number
67857|NCT01129011|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population||participants|||Number
67858|NCT01129011|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population||Participants|||Number
67859|NCT01129011|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intent to Treat (ITT) Population||Participants|||Number
67860|NCT01129011|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population||Participants|||Number
67861|NCT01129011|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||Participants|||Number
67862|NCT01128972|Other Pre-specified|Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent SMH||Standard Error|Least Squares Mean
67863|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent NER||Standard Error|Least Squares Mean
67864|NCT01128972|Other Pre-specified|Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent SMH||Standard Error|Least Squares Mean
67865|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent NER||Standard Error|Least Squares Mean
88107|NCT00928083|Secondary|OZ439 Cmax|Maximum observed plasma drug concentration (Cmax).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||ng/ml||Geometric Coefficient of Variation|Geometric Mean
67866|NCT01128972|Secondary|Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period.|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent SMH||Standard Error|Least Squares Mean
67867|NCT01128972|Primary|Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.||Percent NER||Standard Error|Least Squares Mean
67868|NCT01128959|Primary|Adverse Events||Baseline to after last iv dose on day 4|All Patients Treated Set||Number of adverse events|||Number
67869|NCT01128946|Secondary|Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Mean
67870|NCT01128946|Secondary|%SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group||Percentage||Standard Error|Mean
67871|NCT01128946|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/(D-B)]*100.|Baseline to 14 days|Per Protocol (PP) population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.||Percentage of SMHR||Standard Error|Mean
67872|NCT01128894|Secondary|Mean Change From Baseline in Body Weight at Week 32|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.||Kilograms||Standard Deviation|Mean
67873|NCT01128894|Secondary|Time to Hyperglycemia Rescue at Week 32|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and <Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- >= Week 12 and <Week 26, or HbA1c ≥8.5% >= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.|Week 32|ITT Population||Weeks||95% Confidence Interval|Median
67874|NCT01128894|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32|Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 32|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
67875|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
67876|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
67877|NCT01128894|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
67878|NCT01128894|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 32|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
67879|NCT01128829|Primary|The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)|we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.|Baseline|||(pmol • min •L-1)||Standard Deviation|Mean
67880|NCT01128738|Secondary|Duration of Effect|Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of >50% production in gravimetric assessment compared to Baseline.|Up to Week 40|FAS1||days||95% Confidence Interval|Median
67881|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase|Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67882|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67883|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67884|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67885|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67886|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67887|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67901|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) * 100/mean weight at Baseline in the Second Treatment Phase.|Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|||percent change||Standard Deviation|Mean
67888|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67889|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67890|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67891|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67892|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67893|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67902|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS2 (LOCF dataset)||mg||Standard Deviation|Mean
68072|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.|Month 3 Visit|This analysis included all participants with complete data for the entire study.||Percentage of participants|||Number
67894|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67895|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67896|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67897|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67898|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67899|NCT01128738|Secondary|Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||scores on a scale||Standard Deviation|Mean
67900|NCT01128738|Secondary|Percentage of Responders Assessed by the HDSS in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||percentage of participants|||Number
67903|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS for the Second Treatment Phase (FAS2) (LOCF dataset): all participants who were included in the FAS1, received the second treatment of IP, and had at least one efficacy assessment after the second treatment. One participant who started the Second Treatment Phase was not included in the FAS2 because they had no efficacy assessment in this phase.||percentage of participants|||Number
67904|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase|The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67905|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67906|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67907|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67908|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1 The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67909|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67960|NCT01128270|Primary|Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)|The levels were clinically indetectable at baseline and the question was whether or not substantive levels would be noted at after 5 days exposure to Chloral Hydrate. Detectable, but low levels were detected.|5 days|all eligible participants to arm 2B (Period 4)||micrograms per ml clorohydrate||Standard Deviation|Mean
67910|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67911|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67912|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67913|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67914|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67915|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67916|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
68073|NCT01127139|Secondary|Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.|Baseline to Month 6 Visit|This analysis included all participants with complete data for the entire study.||mmHg||Standard Deviation|Mean
67917|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67918|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67919|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67920|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67921|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67922|NCT01128738|Secondary|Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.||scores on a scale||Standard Deviation|Mean
67923|NCT01128738|Secondary|Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants remaining in the study at the time of the visit, particularly regardless of reinjection after Week 16, was used as the denominator. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.||percentage of participants|||Number
68074|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed after three months of treatment.|Month 3 Visit|All participants with evaluable case report forms were analyzed.||participants|||Number
67924|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) * 100/mean weight at Baseline.|Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.||percent change||Standard Deviation|Mean
67925|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.||milligrams (mg)||Standard Deviation|Mean
67926|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Weeks 1, 8 ,12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.||percentage of participants|||Number
67927|NCT01128738|Primary|Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Week 4|Full Analysis Set for the First Treatment Phase (FAS1): all participants who received the first treatment of investigational product (IP) and had at least 1 post-Baseline efficacy assessment. The analysis was performed using the Last Observation Carried Forward (LOCF) dataset; missing data were imputed by carrying forward the last available data.||percentage of participants|||Number
67928|NCT01128595|Primary|EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
67929|NCT01128595|Primary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
67930|NCT01128595|Primary|LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
67931|NCT01128595|Secondary|Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% fall in FEV1 from the saline value was achieved. After inhalation of saline, 3 measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 22 of each treatment period (up to Study Day 198)|Efficacy Population. Only those participants available at the specified time points were analyzed.||milligrams per milliliter||Standard Deviation|Mean
67961|NCT01128270|Primary|Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate|Elimination Half-life Difference on Arm 2B for 13C-Labeled trichloroacetate between day 5 (prolonged exposure) and day 1 (de novo exposure) after therapeutic level exposure to Chloral Hydrate. This outcome only applies to Period 4. Trichloroacetate is a marker, not an intervention.|5 days|This applies only to Arm 2B (Therapeutic Chloral Hydrate without DCA.||minutes||Standard Deviation|Mean
67932|NCT01128595|Secondary|Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Maximum percent change was calculated as the minimum FEV1 minus the saline FEV1 value divided by the saline FEV1 multiplied by 100. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline FEV1 value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.||percent change||Full Range|Median
67933|NCT01128595|Primary|Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population: all participants who received at least one dose of study medication, had a post-dose FEV1 assessment, and who were not major protocol violators. Only those participants available at the specified time points were analyzed.||Liters||95% Confidence Interval|Least Squares Mean
67934|NCT01128569|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.|From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)|ITT Population||participants|||Number
67935|NCT01128569|Secondary|Minimum FEV1 Absolute Change From Baseline Between 0–2 Hour, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0–2 hour, following the 22–23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model ANCOVA with fixed effects of treatment, period, participant-level Baseline, period level Baseline, country, sex, and age.||Liters||Standard Error|Least Squares Mean
67936|NCT01128569|Secondary|Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, participant-level BL, period level BL, country, sex, and age. Change from BL was calculated as the value on Day 29 minus the BL value.||Percent change||Standard Error|Least Squares Mean
67937|NCT01128569|Primary|Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0–2 Hours, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|Intent-to-Treat (ITT) Population: par. randomized to treatment who received >=1 dose of study drug. Only those par. available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, par.-level Baseline, period level Baseline, country, sex, and age.||Liters||Standard Error|Least Squares Mean
67938|NCT01128543|Secondary|Duration of Response|Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a >=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter.|From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)|All participants randomized to receive at least one dose of study drug. Only those participants with a complete or partial response were evaluated.||months||Inter-Quartile Range|Median
67939|NCT01128543|Secondary|Progression-free Survival|Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.||months||Standard Deviation|Mean
67940|NCT01128543|Primary|Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24|Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for >=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started.|Week 12 and Week 24|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.||participants|||Number
67941|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67942|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67943|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67944|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67945|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67946|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67947|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67948|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67949|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67950|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67962|NCT01128270|Primary|Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.|After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.|6 Days|||micrograms/ml||Standard Deviation|Mean
68075|NCT01127087|Secondary|Total Urinary Oxalate Excretion|Oxalate is a salt of oxalic acid produced by the body's metabolism and excreted in the urine, measured in this study in two, 24-hour, urine collections.|Baseline, 4 weeks|||mg/24 hrs||Standard Deviation|Mean
67951|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67952|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67953|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67954|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67955|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.||ratio||90% Confidence Interval|Number
67956|NCT01128413|Primary|Lactate Clearance|The median lactate clearance from time zero to within 6 hours of the ED stay.|The median lactate clearance within 6 hours of the ED stay.|Only 9 total patients (5 Fluid Optimization; 4 Routine Care) stayed in the Emergency Department for a full 6 hours to allow calculation of a 6 hour lactate clearance. The rest of the patients left were dispositioned out of the ED before the 6 hour mark and therefore unable to calculate a 6 hour lactate clearance.||percent lactate clearance||Inter-Quartile Range|Median
67957|NCT01128400|Primary|Triolein Detection|We will measure triolein detection levels as a marker of subjects' ability to detect triglyceride.|Few weeks after screening|||log10 (%W/V TRIOLEIN)||Standard Error|Mean
67958|NCT01128400|Primary|Oleic Acid Detection Level|We will measure oleic acid detection levels as a marker of subjects' ability to detect free fatty acids.|Few weeks after screening|||log10 (%W/V OLEIC ACID)||Standard Error|Mean
67959|NCT01128270|Secondary|Detectable DCA After Day 1 in Serum (0=No 1=Yes)|All four arms receive Chloral Hydrate on Day 1 (arms 1A and 1B environmental levels) and (arms 2A and 2B therapeutic levels). The question is could Dichloroacetate be detected in serum at the end of day 1. This analysis is purely descriptive, and no comparisons were planned.|1 day|All eligible session completers||participants|||Number
67963|NCT01128244|Secondary|Plasma 3-hydroxykynurenine Concentration|For all subjects, analysis of blood samples before and after vitamin B6 supplementation will allow evaluation of discriminating biomarkers using targeted metabolite profile analysis of one-carbon metabolism and tryptophan catabolism constituents. Also, we will conduct exploratory evaluation and potential identification of new biomarkers using metabolomics analysis on subjects before and after vitamin B6 supplementation.|April, 2010 - June, 2014|Women using oral contraceptives and exhibiting low vitamin B6 status.||microl/L||Standard Deviation|Mean
67964|NCT01128244|Primary|Fasting Plasma Cystathionine Concentration|For all subjects, the concentration of plasma cystathionine in fasting blood samples taken before and after the supplementation period will provide a functional measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.||micromol/L||Standard Deviation|Mean
67965|NCT01128244|Primary|Fasting Plasma Pyridoxal Phosphate Concentration|For all subjects, the concentration of plasma pyridoxal phosphate in fasting blood samples taken before and after the supplementation period will provide a direct measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.||nmol/L||Standard Deviation|Mean
67966|NCT01128244|Primary|Flux of Homocysteine Remethylation From Serine-derived Carbon|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of homocysteine remethylation from serine-derived carbon before and after vitamin B6 supplementation. These flux values may be slightly higher than flux of total homocysteine remethylation in Outcome Measure 1 because of the small contribution of methionine salvage to the flux measured in Outcome Measure 2.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives and exhibiting low vitamin B6 status.||micromol/(kg x hr)||Standard Deviation|Mean
67967|NCT01128244|Primary|Total Remethylation of Homocysteine|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives exhibiting low vitamin B6 status evaluated at baseline and after vitamin B6 supplementation.||micromol/(kg x hr)||Standard Deviation|Mean
67968|NCT01128192|Primary|Change in High-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10|||mg/kg/min||Standard Deviation|Mean
67969|NCT01128192|Primary|Change in Low-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10|||mg/kg/min||Standard Deviation|Mean
67970|NCT01128192|Primary|Change in High Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10|||percentage of EGP inhibition||Standard Deviation|Mean
67971|NCT01128192|Primary|Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10|||percentage of EGP Inhibition||Standard Deviation|Mean
67972|NCT01128192|Primary|Change in Basal Endogenous Glucose Production (EGP)|Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10|||mg/kg/min||Standard Deviation|Mean
67973|NCT01128192|Primary|Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp|Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.|0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)|||h*pmol/L||Standard Deviation|Mean
67974|NCT01128192|Primary|Change in Insulin Basal Level|Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)|-30 min and -15 min on Day 2 and Day 9|||pmol/L||Standard Deviation|Mean
67975|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)|||h*pmol/L||Standard Deviation|Mean
67976|NCT01128192|Secondary|Change Fasting Plasma Insulin Level|An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed.|-30 minutes on Day 1 and -30 minutes on Day 8|||pmol/L||Standard Deviation|Mean
67977|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1.|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)|||h*mmol/L||Standard Deviation|Mean
67978|NCT01128192|Secondary|Change in Fasting Plasma Glucose Level|"An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at~-30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed."|-30 minutes on Day 1 and -30 minutes on Day 8|||mmol/L||Standard Deviation|Mean
67979|NCT01128179|Secondary|Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)||12 weeks|PP||mmol^2/L^2||Standard Error|Least Squares Mean
67980|NCT01128179|Secondary|Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)||12 weeks|PP||mmol/L||Standard Error|Least Squares Mean
67981|NCT01128179|Secondary|Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)||12 weeks|PP||mmol/L||Standard Error|Least Squares Mean
67985|NCT01128179|Primary|Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)|FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.|12 Weeks|Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable.||pg/ml||Standard Error|Least Squares Mean
67986|NCT01128153|Secondary|Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)|Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||Participants|||Number
67987|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mmol/L||95% Confidence Interval|Mean
67988|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mg/dL||95% Confidence Interval|Mean
67989|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mmol/L||95% Confidence Interval|Mean
67990|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||mg/dL||95% Confidence Interval|Mean
67991|NCT01128153|Primary|Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)|Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24 weeks|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.||percent||95% Confidence Interval|Mean
67992|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score|The CGI-S is scored to rate patient’s current clinical state. At enrolment patient’s condition is rated using the CGI-S. At assignment CGI-S is again completed and a score of at least 4 (moderately ill). The score at assignment Day 1 will be regarded as the baseline value. At all following visits CGI-S will be rated. Each CGI item is scored on a scale from 1 to 7. A CGI-S score of 1 indicates that a patient is “Normal, not at all ill” and a score of 7 indicates that a patient is “Among the most extremely ill patients”.|Baseline, week 4||||||
67993|NCT01128114|Secondary|The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4|The Global Improvement scale (CGI-I) is scored to rate the patient’s change from baseline CGI. A CGI-I score of 1 indicates that a patient is “very much improved” and a score of 7 indicates that a patient is “very much worse.” CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement. At all following visits CGI-I will also be rated. The following calculations will be made: Proportion of patients with CGI Global Improvement rating ≤ 2 at Day 29|Baseline, week 4||||||
67994|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score|The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure severity of manic episodes. There are 4 items graded on a 0 to 8 scale (irritability, speech, thought content, disruptive/aggressive behavior), and 7 items graded on 0 to 4 scale. These 4 items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on patients’ clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2.|Baseline, week 4||||||
67995|NCT01128114|Primary|The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)|CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.|Baseline, week 4|As the study was terminated prematurely none of the randomized patients have been analysed.||Participants|||Number
67996|NCT01128049|Primary|Visual Quality|Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.|5 seconds|The comparison was between normal, non-dry eye participants and dry eye groups.||microns||Standard Deviation|Mean
67997|NCT01127763|Primary|Toxicity Profile-Non Hematological|Reported as percentage of patients who experienced grade 3 and higher non-hematological AEs related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.||percentage of patients|||Number
67998|NCT01127763|Secondary|Median Progression-free Survival Time|Progression-free survival time is defined as the time from first day of treatment to the first date of disease progression or death as a result of any cause. Progression was assessed every 2 cycles of treatment (6 weeks) by CT, CT/PET, or MRI. Progression is defined using RECIST 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 1 year|Any patient with at least one dose of treatment.||months||95% Confidence Interval|Median
67999|NCT01127763|Primary|Toxicity Profile-Hematological|Reported as percentage of patients who experienced grade 3 and higher hematological adverse events (AEs) related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.||percentage of patients|||Number
68000|NCT01127763|Primary|Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months)|Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 1 year|Any patient with at least one dose of treatment.||percentage of patients||95% Confidence Interval|Number
68001|NCT01127737|Primary|Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention|The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.|1 month|Per protocol||Participants|||Number
68002|NCT01127646|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.||millimeters of mercury (mm Hg)||Standard Deviation|Mean
68003|NCT01127646|Other Pre-specified|Change From Baseline in Heart Rate up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
68004|NCT01127646|Secondary|Global Impression of Perceived Difficulties Investigator Version (GIPD-Inv) Total Score and Subscores At Weeks 2, 3, and 4|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, and over entire day and night). Difficulties during past week are rated by investigator on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68005|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score During the 4-Week Treatment Period|The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conners’ Global Index-Teacher Rating Scale total score for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68006|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Total Score and Subscores During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 3 common morning behaviors (such as, get out of bed) and 8 common evening behaviors (such as, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. Mean DPREMB-R total score and subscores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68007|NCT01127646|Secondary|Patient Outcomes Questions (On-Days Versus Off-Days) During the 4-Week Treatment Period|"6-item questionnaire from attention-deficit/hyperactivity disorder (ADHD) advocacy group evaluates treatment outcomes ADHD participant's perspective. Parent completed on each day of on/off period. Each item ranged from 1 (I totally agree) to 5 (I totally disagree). Items 1 and 2 pertain to sleeping and eating; high scores=better outcome. Items 3-6 pertain to behavior; high scores=worse outcome. The mean scores for analysis would have been created for each question across the days of each of the on and off phases; however, mean scores were not analyzed due to insufficient sample size."|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68008|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Subscores (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R subscores between days without missing doses (on-days) and days with missing doses (off-days) not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68028|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68009|NCT01127646|Secondary|Emotion Expression Scale for Children (EESC)-Parent Rated Total Score up to Week 5|"29-item parent-reported measure used to monitor effect of attention-deficit/hyperactivity disorder (ADHD) medication; examines 3 aspects of emotion expression: positive emotions, emotional flatness, and emotional lability. Each item rated on 5-point Likert scale (1=not at all true to 5=very much true). Positive emotional subscale items reversed scored (6-raw score). Total score=transformed positive emotion + emotional flatness+ emotional lability subscales. Total scores range: 29 to 145. Higher scores=emotional impairment. This outcome measure not analyzed due to insufficient sample size."|Up to Week 5|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68010|NCT01127646|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) at Weeks 2, 3, and 4|This instrument is a single-item expert rating of the severity of the participant’s attention-deficit/hyperactivity disorder (ADHD) symptoms in relation to the assessor’s total experience of participants with ADHD. Severity is rated on a 7-point scale (1=normal, not ill at all; 7=among the most extremely ill participants). Higher scores represent greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68011|NCT01127646|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator Administered and Scored (ADHD-RS-IV Parent:Inv) Total Score and Subscores at Weeks 2, 3, and 4|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68012|NCT01127646|Secondary|Global Impression of Perceived Difficulties Scale-Patient Version (GIPD-Pat) Scale Total Score and Individual Items During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Difficulties during past week are rated by participant on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. Mean GIPD-Pat total score and individual item scores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68013|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|The teacher version of Conners’ Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conner’s Global Index-Teacher Rating Scale total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68014|NCT01127646|Secondary|Global Impression of Perceived Difficulties (GIPD) Scale-Patient Version Total Score and Individual Items (On-Days Versus Off-Days) During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Participant rates difficulties during past week on 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. GIPD-Pat total score and item scores between days without missing doses (on-days) and days with missing doses (off-days) were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68015|NCT01127646|Primary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Mean Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||||
68016|NCT01127607|Secondary|Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase|Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.|baseline and end of med optimization phase/week 4|Uses a within-subjects design; the same 27 participants are in both arms.||scores on a scale||Standard Deviation|Mean
68029|NCT01127607|Secondary|Impairment Rating Scale (IRS)|measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child’s problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68030|NCT01127607|Secondary|Disruptive Behavior Disorder Rating Scale (DBD)|measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68017|NCT01127607|Secondary|Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More|Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).|end of medication optimization phase/week 4|Within-subjects analysis; data entered per dose not per subject. For example, if subject 1 took 30mg, 50mg and 70mgdoses during titration, they are recorded as three separate entries. Sample size reduces as dose increases because participants stopped at lowest acceptable dose and only moved to higher dose if they did not meet optimization criteria.||Percent of participants|||Number
68018|NCT01127607|Secondary|Resting Pulse|measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).|study endpoint- end of period II (between subjects trial)|||bpm||Standard Deviation|Mean
68019|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.||Percentage of behaviors||Standard Deviation|Mean
68020|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.||behaviors||Standard Deviation|Mean
68021|NCT01127607|Secondary|Weight|Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).|study endpoint- end of period II (between subjects trial)|||kg||Standard Deviation|Mean
68022|NCT01127607|Secondary|Impairment Rating Scale (IRS)|self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68023|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.~At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68024|NCT01127607|Secondary|Resting Blood Pressure|Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)|||mm Hg||Standard Deviation|Mean
68025|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale Mean Severity Rating.|rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68026|NCT01127607|Secondary|Barkley Home Situations Questionnaire (HSQ)|Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)|||number of child problems endorsed||Standard Deviation|Mean
68031|NCT01127607|Secondary|Social Skills Rating System (SSRS)|"Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 (never) to 2 (often).At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior)."|study endpoint- end of period II (between subjects trial)|||standard scores||Standard Deviation|Mean
68032|NCT01127607|Secondary|Brown Attention Deficit Scale (BAADS)|"Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 (never) to 3 (almost daily). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)|||t score||Standard Deviation|Mean
68033|NCT01127607|Secondary|Parenting Locus of Control (PLC)|"self completed parenting measure of the degree to which parents feel they can influence their child’s behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 (strongly disagree) to 5 (strongly agree). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68034|NCT01127607|Secondary|Parenting Stress Index (PSI)--Total Stress|measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68035|NCT01127607|Secondary|Adult ADHD Rating Scale (ADHD RS)|measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|||units on a scale||Standard Deviation|Mean
68036|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale|rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization.|baseline and end of dose optimization phase/week 4|Within-subjects analysis; same 26 participants are in the unmedicated and optimal dose of medication arms.||units on a scale||Standard Deviation|Mean
68037|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design; the same 26 participants completed all arms.||Percentage of behaviors||Standard Deviation|Mean
68038|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS)|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design for this phase; the same 26 participants completed all four arms.||behaviors||Standard Deviation|Mean
68039|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication.|baseline and week 4|Uses a within-subjects design; the same 25 participants are in both arms.||units on a 0 to 10 scale||Standard Deviation|Mean
68055|NCT01127438|Secondary|Number of Participants With Treatment Success|Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.|Day 1|Full Analysis Population.||Participants|||Number
68675|NCT01121666|Secondary|Number of Patients With Cycle Cancellation|Number of patients with cycle cancellation was assessed.|Until child birth/miscarriage, up to the end of the study|Intention to treat population||Number of patients|||Number
68040|NCT01127607|Secondary|Impairment Rating Scale (IRS)|"Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by no problems / no need for treatment and at the high end by extreme problem / definitely needs treatment. Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Uses a within-subjects evaluation; the same 25 participants are in both arms.||units on a 0 to 6 scale||Standard Deviation|Mean
68041|NCT01127607|Secondary|Disruptive Behavior Disorders Rating Scale (DBD)|Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms.|baseline and week 4|Used a within-subjects design; the same 24 participants measured in both arms.||units on a scale||Standard Deviation|Mean
68042|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.~Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Used a within-subjects evaluation; the same 24 participants evaluated in both arms.||units on a scale||Standard Deviation|Mean
68043|NCT01127581|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.|From study drug administration to hospital discharge (approximately 48-72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.||percentage of participants|||Number
68044|NCT01127581|Secondary|Incidence of Vaginal Delivery||Interval from study drug administration to vaginal delivery (average 24 hours)|The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses.||percentage of participants||95% Confidence Interval|Number
68045|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 24 Hours||Interval from study drug administration to vaginal delivery within 24 hours|Intention-to-Treat (ITT) Population||percentage of participants||95% Confidence Interval|Number
68046|NCT01127581|Secondary|Incidence of Any Delivery Within 12 Hours||Interval from study drug administration to delivery of neonate within 12 hours|Intention-to-Treat (ITT) Population||percentage of participants||95% Confidence Interval|Number
68047|NCT01127581|Secondary|Incidence of Any Delivery Within 24 Hours||Interval from study drug administration to delivery of neonate within 24 hours|Intention-to-Treat (ITT) Population||percentage of participants||95% Confidence Interval|Number
68048|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 12 Hours||Interval from study drug administration to vaginal delivery within 12 hours|Intention-to-Treat (ITT) population||percentage of participants||95% Confidence Interval|Number
68049|NCT01127581|Secondary|Incidence of Pre-delivery Oxytocin During the First Hospital Admission|Percentage of participants in receipt of Oxytocin for induction after study drug removal.|At least 30 minutes after study drug removal|Analysis population includes subjects who delivered during the first hospitalization.||percentage of participants||95% Confidence Interval|Number
68050|NCT01127581|Secondary|Time to Active Labor During the First Hospital Admission|Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.|Interval from study drug administration to active labor (average 12 hours)|Intention-to-Treat (ITT) population||minutes||95% Confidence Interval|Median
68051|NCT01127581|Secondary|Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission||Interval from study drug administration to neonate delivery (average 24 hours)|Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge.||minutes||95% Confidence Interval|Median
68052|NCT01127581|Primary|Incidence of Cesarean Delivery During the First Hospital Admission||Interval from study drug administration to cesarean delivery (average 24 hours)|Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event.||percentage of participants||95% Confidence Interval|Number
68053|NCT01127581|Primary|Time to Vaginal Delivery During the First Hospital Admission||Interval from study drug administration to vaginal delivery (average 24 hours)|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored.||minutes||95% Confidence Interval|Median
68054|NCT01127438|Secondary|Number of Participants With Modified Sedation Success|Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.|Day 1|Full Analysis Population.||Participants|||Number
68056|NCT01127438|Primary|Number of Participants With Sedation Success|Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject’s level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.|Day 1|Full Analysis Population: All treated subjects who received study drug and had at least one postdose efficacy measurement.||Participants|||Number
68057|NCT01127321|Secondary|Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit||Predose on Day 1; Day 85, 113, and 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.||participants|||Number
68058|NCT01127321|Secondary|Pharmacokinetic Parameters for MEDI-570|Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169|Due to early termination of the study, the results were reported as individual participant’s listings but not statistically summarized.|||||
68059|NCT01127321|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 to Day 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.||participants|||Number
68060|NCT01127256|Secondary|Quality of Life in Epilepsy (QoL-QOLIE31)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|24 weeks|||Units On a Scale||Standard Deviation|Mean
68061|NCT01127256|Secondary|The Percentage of Participants With Retention Rate|The percentage of participants who completed the trial.|24 weeks|||percentage of participants|||Number
68062|NCT01127256|Primary|The Percentage of Participants With Seizure Free Rate|The percentage of participants who had no seizure during the trial.|24 weeks|||percentage of participants|||Number
68063|NCT01127165|Secondary|Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)|The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life.|Baseline and 24 weeks|||Scores on a Scale||Standard Deviation|Mean
68064|NCT01127165|Secondary|Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)|The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children’s behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems.|Baseline and 24 weeks|||Scores on a Scale||Standard Deviation|Mean
68065|NCT01127165|Secondary|Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)|Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement.|Baseline and 24 weeks|||Scores on a Scale||Standard Deviation|Mean
68066|NCT01127165|Primary|Percentage of Participants Who Were Assessed As Seizure Free|The percentage of participants who showed no seizure during the maintenance phase.|24 weeks|||percentage of participants|||Number
68067|NCT01127139|Secondary|Adverse Events Leading to Study Discontinuation|The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.|Baseline to Month 6 Visit|All participants with case report forms were included in this analysis.||Participants|||Number
68068|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 6 Visit|This analysis included all participants with complete data for the entire study.||Participants|||Number
68069|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed since their previous visit.|Month 6 Visit|All participants with evaluable case report forms were analyzed.||participants|||Number
68070|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 3 Visit|This analysis included all participants with complete data for the entire study.||Participants|||Number
68071|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.|Month 6 Visit|This analysis included all participants with complete data for the entire study.||Percentage of participants|||Number
68076|NCT01127087|Primary|Urinary Oxalate Creatinine Ratio|The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.|Baseline, Week 4|||mg/g||Standard Deviation|Mean
68077|NCT01126801|Secondary|Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.||one month||||||
68078|NCT01126801|Primary|Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.||one month|No participants were analyzed since the study was terminated due to difficulty recruiting subjects.|||||
68079|NCT01126723|Primary|Frailty Index|Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.|post-intervention|per protocol||participants|||Number
68080|NCT01126671|Secondary|Assessment of Bone Markers at Follow-up|After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.|12 weeks||||||
68081|NCT01126671|Secondary|Baseline Assessment of Bone Markers|Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation|Baseline||||||
68082|NCT01126671|Primary|Follow-up 25OHD Levels|After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.|12 weeks|||ng/ml||Standard Deviation|Mean
68083|NCT01126671|Primary|Baseline 25OHD Levels|25OHD will be drawn at baseline prior to starting vitamin D supplementation.|Baseline|||ng/ml||Standard Deviation|Mean
68084|NCT01126619|Secondary|Number of Participants With Adverse Events (AEs)|"The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.~Please see the Adverse Event module below for additional details."|24 Weeks|All enrolled participants.||participants|||Number
68085|NCT01126619|Secondary|Percent Change From Baseline in Work Productivity and Activity Impairment|"The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):~Percent work time missed in the last 7 days due to problems associated with psoriasis;~Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;~Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;~Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.~Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. The first 3 domains (work time missed, work impairment and overall loss of work productivity) were assessed on a sub-group of participants who had full time jobs (n=30).||percent change||Full Range|Mean
68086|NCT01126619|Primary|Percentage of Participants With 75% Reduction in PASI Score|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||percentage of participants|||Number
68087|NCT01126619|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.~Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||percent change||Full Range|Mean
68088|NCT01126619|Secondary|Static Physician Global Assessment (PGA) of Psoriasis|"In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:~Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||participants|||Number
68089|NCT01126619|Secondary|Dynamic Patient Global Assessment (PGA) of Change in Psoriasis|In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||scores on a scale||Standard Deviation|Mean
68090|NCT01126619|Secondary|Dynamic Physician Global Assessment (PGA) of Change in Psoriasis|In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from –5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||scores on a scale||Standard Deviation|Mean
68215|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68091|NCT01126619|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.||Percent change||Standard Deviation|Mean
68092|NCT01126593|Primary|Pain Scores|Pain was measured via Visual Analong Scale in measurement (0-100mm).|O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.|||mm||Standard Deviation|Mean
68093|NCT01126580|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
68094|NCT01126580|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin.||participants|||Number
68095|NCT01126580|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.||participants|||Number
68096|NCT01126580|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
68097|NCT01126580|Secondary|Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.||events|||Number
68098|NCT01126580|Secondary|Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
68099|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||picograms per milliliter (pcg/mL)||Inter-Quartile Range|Median
68100|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter (U/L)||Inter-Quartile Range|Median
68101|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides|Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable triglyceride data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||percentage change in triglycerides||Inter-Quartile Range|Median
68102|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)|Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable LDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||percentage change in LDL-C||Inter-Quartile Range|Median
68103|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)|Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing||percentage change in HDL-C||Inter-Quartile Range|Median
68104|NCT01126580|Secondary|Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol|Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable cholesterol data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage change in total cholesterol||Inter-Quartile Range|Median
68105|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable blood pressure data.||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
68106|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
68107|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
68108|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG QTcF interval or PR interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
68109|NCT01126580|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin.||participants|||Number
68110|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score|The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=“extremely” to 1=“not at all.” For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DSC-r data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
68136|NCT01126541|Secondary|SF-12 Mental Health Composite Score|Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
68111|NCT01126580|Secondary|Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQc data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
68112|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
68113|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
68114|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score."|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
68115|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
68116|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable BMI data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
68117|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
68676|NCT01121666|Secondary|Number of Days of r-hFSH Stimulation|Mean duration of stimulation was assessed.|At the day of hCG administration, up to 16 days|All participants were analyzed.||days||Standard Deviation|Mean
68118|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable SMBG data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
68119|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable fasting blood glucose data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
68120|NCT01126580|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
68121|NCT01126580|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
68122|NCT01126580|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
68123|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Pain in Participants With MCII|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68124|NCT01126541|Secondary|Percentage of Participants With MCII in Pain|Participants were asked how their pain had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse pain.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
68125|NCT01126541|Secondary|Patient Global Assessment of Pain in Participants Reporting Acceptable Symptoms Using PASS|Patient Global Assessment of Pain assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. Higher values correspond to worst state of participant (high pain levels).|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68126|NCT01126541|Secondary|Percentage of Participants With Acceptable Symptom State in Pain Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
68137|NCT01126541|Secondary|Short Form 12 (SF-12) Physical Health Composite Score|Physical and Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
68127|NCT01126541|Secondary|Change From Baseline in HAQ-DI in Participants With MCII|HAQ-DI was assessed in participants with MCII. HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
68128|NCT01126541|Secondary|Percentage of Participants With MCII in Functioning|Participants were asked how their functioning had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
68129|NCT01126541|Secondary|HAQ-DI Scores in Participants Reporting Acceptable Function Using PASS|HAQ-DI was assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours). HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
68130|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Symptom State in Functioning Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of function they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of function they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
68131|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity in Participants With MCII|The Patient's Global Assessment of Disease Activity was assessed in participants reporting MCII on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68132|NCT01126541|Secondary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) in Disease Activity|Participants were asked how their disease activity had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more disease activity.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
68133|NCT01126541|Secondary|Patient Global Assessment of Disease Activity in Participants Reporting Acceptable Symptoms Using PASS|The Patient's Global Assessment of Disease Activity assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68134|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Disease Activity Symptom State Assessed Using Patient Acceptable and Unacceptable Symptom State (PASS)|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of disease activity they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population||percentage of participants|||Number
68135|NCT01126541|Secondary|Medical Outcomes Study Sleep Scale (MOS-Sleep) Composite Sleep Problems 6 (SLP6) Index|The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The SLP6 index is comprised of 6 items: provides a summary of sleep problems and contains questions from the sleep disturbance, sleep adequacy, respiratory impairment, and somnolence domains. The SLP6 index score ranges between 0 and 100, with higher values corresponding to more sleep problems.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population;n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
68171|NCT01126437|Primary|Time to All-Cause Mortality|Number of patients with all-cause mortality|Up to 3 years|Death analysis set (DAS) including vital status follow-up: This analysis set included all randomized subjects excluding only subjects who were documented as not treated.||Number of deaths|||Number
68138|NCT01126541|Secondary|HAQ-DI Scores|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
68139|NCT01126541|Secondary|Total Mean Dose of Cortisone Between Week 24 and Week 104|All cortisone intakes were taken into account, including oral, IV (including the cortisone administration before the rituximab infusion), intramuscular and intra-articular.|Week 24 to Week 104|ITT population||mg||Standard Deviation|Mean
68140|NCT01126541|Secondary|Cortisone Intake AUC (Time- and Weight-Weighted)|All cortisone intakes (in mg) were taken into account (oral, IV [including the cortisone administration before the rituximab infusion], intramuscular, and intra-articular).|Day 1 (each infusion), Week 24, Week 104|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mg*week||Standard Error|Mean
68141|NCT01126541|Secondary|Participant Assessment of Fatigue|"Participants were asked to rate their level of fatigue over the last 7 days on a 100-mm VAS. The left-hand extreme of the line equals 0 mm, and is described as “no fatigue” and the right-hand extreme equals 100 mm as “extreme fatigue. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high levels of fatigue)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68142|NCT01126541|Secondary|Patient's Global Assessment of Pain|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68143|NCT01126541|Secondary|Patient Global Assessment of Disease Activity|The Patient's Global Assessment of Disease Activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68144|NCT01126541|Secondary|Physician's Global Assessment of Disease Activity|The Physician’s Global Assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Physicians were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high disease activity).|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
68145|NCT01126541|Secondary|Percentage of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at 24 Weeks After Treatment|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
68146|NCT01126541|Secondary|Percentage of Participants With Rheumatoid Factor (RF) at 24 Weeks After Treatment|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 international units per milliliter (IU/mL) is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
68147|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Retreatment by EULAR Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Week 24, 24 weeks after 1st retreatment, 24 weeks after 2nd retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
68148|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Initial Treatment by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Day 15, Weeks 6, 12, and 24|Overall population||percentage of participants|||Number
68149|NCT01126541|Secondary|Percentage of Participants Achieving American College of Rheumatology 20%, 50%, and 70% Improvement (ACR20/ACR50/ACR70)|ACR20/50/70 response defined as ≥20%, 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%, 50%, or 70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: Patient Global Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity (on a visual analog scale [VAS]); Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP.|Week 24 of the initial treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population||percentage of participants|||Number
68150|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
68151|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during first course of treatment (at any point) were included in the analysis.||weeks||95% Confidence Interval|Median
68152|NCT01126541|Secondary|Duration of DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
68153|NCT01126541|Secondary|Duration of DAS28-CRP Remission After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during initial treatment (at any point) were included in the analysis.||weeks||95% Confidence Interval|Median
68154|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
68155|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population||weeks||95% Confidence Interval|Median
68156|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.||weeks||95% Confidence Interval|Median
68157|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After the First Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population||weeks||95% Confidence Interval|Median
68158|NCT01126541|Secondary|DAS28-CRP AUC Weighted Time|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population||units on a scale*week||Standard Deviation|Mean
68159|NCT01126541|Secondary|Percentage of Participants Achieving Clinical Remission (DAS28-CRP <2.6) or Low Disease Activity (DAS28-CRP ≤3.2)|Percentage of participants with clinical remission and low disease activity as measured by DAS28-CRP for Arm A and Arm B at Week 24 of the Initial Treatment, at 24 weeks after first re-treatment, and at 24 weeks after second retreatment. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity and <2.6 = remission.|Week 24 of the Initial Treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
68195|NCT01126268|Secondary|Number of Participants Who Were a Therapeutic Success|Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a “clinical success” and a “microbiological success” were deemed a “therapeutic success,” and all others were deemed “therapeutic failures.”|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68160|NCT01126541|Primary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) Area Under the Curve (AUC) at Week 104|DAS28-CRP was based on joint counts, overall participant assessment, and serum CRP levels (measured in milligrams per liter [mg/L]) at each visit. Joint counts included swollen joint count (SJC) and tender joint count (TJC). Total score range was 0 to 9.4; a higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and less than (<)2.6 equals (=) remission. The AUC of all DAS28-CRP values between Day 1 and Week 104 (15 values of protocol visits) was calculated using the trapeze method (AUC between t1 and t2=(t2-t1)*((DAS28-CRP at t1 + DAS28-CRP at t2)/2). The true visit dates were used to calculate the time between 2 DAS28-CRP evaluations. All the AUC were censored at Week 104 (linear extrapolation using the 2 last DAS28-CRP values (Weeks 96 and 104) to obtain the “true” DAS28-CRP value at the “true” Week 104).|Week 104|Per Protocol (PP) population: all randomized participants in the Intent-to-Treat (ITT) population (defined as all randomized participants) without major protocol violations. Participants were grouped according to their initially assigned treatment arm irrespective of the treatment actually received.||score on a scale*week||Standard Error|Mean
68161|NCT01126541|Secondary|DAS28-CRP and Changes From Baseline to Week 24 in DAS28-CRP by Retreatment Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Day 1, 24 weeks following each infusion up to 72 Weeks|ITT Population; number (n)=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
68162|NCT01126541|Secondary|DAS28-CRP During the Initial Treatment|Mean DAS28-CRP at Week 24 of the Initial Treatment study. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, and Weeks 6, 12, and 24|Overall population: all participants with at least one treatment intake.||units on a scale||Standard Deviation|Mean
68163|NCT01126437|Secondary|Time to Death From Major Adverse Cardiovascular Event (MACE)|The results presented below are number of patients with death from MACE.|Up to 3 years|TS including vital status follow−up, DAS||Number of deaths from MACE|||Number
68164|NCT01126437|Secondary|Time to Onset of First Major Adverse Cardiovascular Event (MACE)|Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE.|Up to 3 years|Treated set - on treatment only||number of patients with MACE|||Number
68165|NCT01126437|Secondary|Time to First Moderate to Severe COPD Exacerbation|"COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).~Exacerbations classified as follows:~Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.~Results presented below are number of patients with moderate to severe exacerbations."|Up to 3 years|treated set - on treatment only||number of patients with event|||Number
68166|NCT01126437|Secondary|Number of Hospitalizations Associated With COPD Exacerbation|Total number of hospitalizations associated with COPD exacerbation.|Up to 3 years|treated set - on treatment only||number of hospitalizations|||Number
68167|NCT01126437|Secondary|Time to First Hospitalization Associated With COPD Exacerbation|The results presented below are for the patients with hospitalizations due to COPD exacerbations.|Up to 3 years|treated set - on-treatment only||Number of patients with event|||Number
68168|NCT01126437|Secondary|Number of COPD Exacerbations|"The number of COPD exacerbations. COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines)."|Up to 3 years|Treated Set - on treatment only||number of COPD exacerbations|||Number
68169|NCT01126437|Secondary|Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)|Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients)|Up to 3 years|SSS - PFT - Sub-study set (pulmonary function testing). This analysis set included all subjects in the TS who signed informed consent to participate in the spirometry sub-study and had at least baseline and one on-treatment trough FEV1.||Liter||Standard Error|Least Squares Mean
68170|NCT01126437|Primary|Time to First COPD Exacerbation|"Defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).~Onset of exacerbation was defined by the onset of first recorded symptom. The end of exacerbation was decided by the investigator based on clinical judgement.~Exacerbations were classified as follows:~Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization."|Up to 3 years|Treated set (TS, on-treatment only)||days to event||95% Confidence Interval|Median
68172|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Speed of Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Speed of Memory was calculated from the sum of 4 cognitive function speed tests: numeric and spatial working memory and word and picture recognition. A low score reflects that a person is able to recall a name, a face or any other item fast from the episodic secondary memory; a positive change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||msec||Standard Deviation|Mean
68173|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||Scores on a scale||Standard Deviation|Mean
68174|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Quality of working memory is calculated from the sum of two cognitive function sensitivity tests: Numeric Working Memory Sensitivity and Spatial Working Memory Sensitivity, and ranges from -2 to 2. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||Scores on a scale||Standard Deviation|Mean
68175|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score – Continuity of Attention|Cognitive effects were assessed using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. For continuity of attention, the number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||Scores on a scale||Standard Deviation|Mean
68176|NCT01126424|Secondary|Change From Baseline in Postural Stability Test|"The postural stability test measures the ability to stand upright without moving, and was assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Using apparatus modeled on the Wright Ataxia-meter, a cord from the meter is attached to the patient who is required to stand as still as possible with feet apart and eyes closed for 1 minute.~The amount of sway is expressed as the total angular movement, summed regardless of sign, in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Wright (1971) described a range of 20-30 units as a normal range for adults with eyes wide open, increasing by 50 to 100% with eyes shut."|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||1/3 degree of angle of sway||Standard Deviation|Mean
68196|NCT01126268|Secondary|Microbiologic Response at Follow up as Assessed by a Rating Scale|Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a “microbiological success” while all others were considered “microbiological failure.”|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68177|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Power of Attention|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.||msec||Standard Deviation|Mean
68178|NCT01126359|Secondary|Break-through Narcotic Requirement|Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.|20 minutes|||Narcotic Requirements (mg)||95% Confidence Interval|Mean
68179|NCT01126359|Primary|Visual Analog Scale Pain Score|Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).|20 minutes|||Visial Analog Pain Score (VAS)||95% Confidence Interval|Mean
68180|NCT01126268|Secondary|Number of Participants Reporting Any Adverse Event (AE)|AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.|baseline to 6 to 8 days after treatment|All participants who received at least 1 dose of Retapamulin (Altabax)||participants|||Number
68181|NCT01126268|Secondary|Wound Size at Follow up|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||cm^2||Standard Deviation|Mean
68182|NCT01126268|Secondary|Wound Size at Baseline|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||cm^2||Standard Deviation|Mean
68183|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68184|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68185|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68186|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68187|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68188|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68189|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68190|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68191|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68192|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68193|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68194|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68197|NCT01126268|Secondary|Clinical Response at Follow up as Assessed by a Rating Scale|Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true “clinical success” while all others were considered a “clinical failure.” Patients were classified with an outcome of “unable to determine” if they missed their follow-up visit or refused clinical examination.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing||participants|||Number
68198|NCT01126268|Primary|Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit|Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.|6 to 8 days after treatment|Participants whose wound cultures were positive for MRSA||participants|||Number
68199|NCT01126099|Secondary|Days in Study|The number of days participants remained in the study during the Double Blind Phase. Please note that although the length of follow-up designated in the protocol was 12 weeks, a number of participants were in this phase longer (e.g. the dose titration phase took longer than 3 weeks, assessments were delayed due to scheduling conflicts, etc.) Therefore the length of time in the Double Blind Phase can exceed 12 weeks (84 days).|12 weeks after Baseline|7 participants in the prazosin group were in the double-blind phase longer than 12 weeks (84 days). 4 participants in the placebo group were in the double-blind phase longer than 12 weeks (84 days).||days||Standard Deviation|Mean
68200|NCT01126099|Primary|Change in Neuropsychiatric Inventory Score|Neuropsychiatric Inventory score change from Baseline to last observation.The Neuropsychiatric Inventory is a scale that quantifies behavioral and psychiatric symptoms in patients with dementia. The scale ranges from 0 to 144, with 0 being no symptoms.|12 weeks|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.||units on a scale||Standard Deviation|Mean
68201|NCT01126099|Secondary|Change in Brief Psychiatric Rating Scale Total Score|Brief Psychiatric Rating Scale score change from Baseline to last observation. The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains. The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms.|12 Weeks after Baseline|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.||units on a scale||Standard Deviation|Mean
68202|NCT01126099|Primary|Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change|This scale represents the raters overall impression of improvement or worsening, and is assessed at the last visit. 1 = Marked improvement, 1 = Moderate improvement, 3 = Minimal improvement, 4 = No change, 5 = Minimal worsening, 6 = Moderate worsening, 7 = Marked worsening.|12 Weeks after Baseline|Any participant who had at least one follow-up assessment was included in the analysis. One participant in the Placebo group did not return for follow-up, and therefore was not included in the analysis.||units on a scale||Standard Deviation|Mean
68203|NCT01126060|Primary|Postoperative Drainage Amount|method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL|serial measurement from 1day to 4day after surgery|||mL||Standard Deviation|Mean
68204|NCT01125930|Secondary|Skin Irritation Assessed by Facial Burning Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
68205|NCT01125930|Secondary|Skin Irritation Assessed by Facial Itching Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
68206|NCT01125930|Secondary|Skin Irritation Assessed by Facial Stinging Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
68207|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.||participants|||Number
68208|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68209|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68210|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68211|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Dryness/Irritation|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68212|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Facial Edema|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68213|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Telangiectasia|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68214|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68216|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68217|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|"Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions Do you have flushing?."|24 weeks|LOCF, Complete Case ITT Population||participants|||Number
68218|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68219|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68220|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68221|NCT01125930|Secondary|Molecular Evidence of Photodamage|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).|24 weeks|ITT Population that completed baseline and week 24 biopsies||fold change||Standard Deviation|Mean
68222|NCT01125930|Secondary|Molecular Markers of Inflammation|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).|24 weeks|ITT Population that completed baseline and Week 24 biopsies||fold change||Standard Deviation|Mean
68223|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Papulopustular|Signs of other rosacea subtypes includes papulopustular, inflammatory papule count|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population||inflammatory papule||Standard Deviation|Mean
68224|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68225|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68226|NCT01125930|Secondary|Photodamage|Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.|24 weeks|LOCF, Complete-Case ITT Population||participants|||Number
68227|NCT01125930|Secondary|Quality of Life|The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population||units on a scale||Standard Deviation|Mean
68228|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT population||participants|||Number
68229|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population||participants|||Number
68230|NCT01125917|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).|52-week extension phase|The Extension Safety Population (N = 354) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.||participants|||Number
68231|NCT01125813|Primary|Efficacy of Treating Bleeding Episodes|"At the end of a bleeding episode, efficacy was assessed as:~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated"|After each bleeding episode, up to 6 month|||Percentage of treatments|Participants||Number
68232|NCT01125813|Primary|Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months|Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.|At least 50 Exposure Days and at least 6 months|All subjects who started prophylactic treatment were evaluated.||Bleeds per month||Standard Deviation|Mean
68273|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction and for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.||mL/mg||Standard Deviation|Mean
68233|NCT01125800|Primary|Percentage of Participants With Objective Response Rate (ORR) by Treatment|The tumor response to the sonidegib treatment was measured by ORR. The ORR was defined as the percentage of participants with partial response or complete response as their best overall response. Participants with stable disease, progressive disease tumor assessment were considered as non-responders. Response evaluation criteria was gadolinium chelate-enhanced brain tumor magnetic resonance imaging (Gd-MRI) for Medulloblastoma and central nervous system (CNS) tumors and response evaluation criteria in solid tumors (RECIST) version 1.0 for non-CNS tumors assessed by MRI. Complete Response (CR), Progressive Disease (PD) and Incomplete Response/Stable Disease (SD) were defined as disappearance of all non-target lesions, unequivocal progression of existing non-target lesions and Neither CR nor PD, respectively.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.||Percentage of participants|||Number
68234|NCT01125800|Secondary|Duration of Response by Treatment|Duration of overall response (complete response (CR) or partial response (PR)) was calculated for those participants whose best overall response was CR or PR. The start date was the date of the first documented tumor response (CR or PR) and the end date was the date of the event defined as the first documented progression or death due to underlying cancer or after the same treatment line. If a participant did not have a progression or death, the duration of response was censored at the date of last adequate tumor assessment in that treatment line.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|"The analysis was performed in FAS population. Here Number of participants analysed” signifies treatment responders for the specified reporting group."||months||Full Range|Median
68235|NCT01125800|Secondary|Percentage of Pediatric Participants With Objective Response Rate (ORR) by Hedgehog (Hh) Signaling Pathway Status|ORR was determined in the participants with mutations on Hh gene (Hh positive) and the participants without mutations on Hh gene (Hh negative).|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|60 patients with known (Hedgehog) Hh pathway activation status were analyzed, 10 patients, including all 5 patients with an objective response (3 with pediatric) , were Hh-positive (+). No Hh-negative patient had an objective response.||% pediatric Hh + responders|||Number
68236|NCT01125800|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sonidegib in Phase I|Maximum observed plasma concentration following drug administration was calculated from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||nanograms/millitres(ng/mL)||Standard Deviation|Mean
68237|NCT01125800|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sonidegib in Phase I|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||hours||Full Range|Median
68238|NCT01125800|Secondary|Area Under the Drug Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24h) of Sonidegib in Phase I|AUC(0-24h) was defined as the area under the drug concentration time curve calculated using linear trapezoidal summation from time zero to 24 hours after dosing.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in pharmacokinetic analysis set (PAS), defined as all the participants who received at least one (full or partial) dose of sonidegib and provided at least one evaluable pharmacokinetic (PK) blood sample. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||nanograms*hours/millilitres (ng*hr/mL)||Standard Deviation|Mean
68239|NCT01125800|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs were defined as AEs that were suspected to be related to study treatment as per investigator. On-treatment deaths were deaths which occurred up to 30 days after last date of study treatment.|Baseline (start of study treatment) up to End of treatment (Within 14 days of last dose)|The analysis was performed in safety set (SS), defined as all the participants who received at least 1 dose of sonidegib.||participants|||Number
68240|NCT01125800|Primary|Maximum Tolerated Dose (MTD) of Sonidegib for Prolonged Use|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose-limiting toxicity (DLT), based on Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications.k|Baseline, End of dose escalation part (Day 42)|The MTD for the pediatric population was not established in this study. MTD was not achieved since 1 or no DLT was observed. The recommended phase II dose was established based on the safety, pharmacokinetics, and clinical responses observed.||mg/m^2|||Number
68241|NCT01125800|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Phase I|DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications. DLT included any grade 3 or 4 clinically-evident toxicity, Hematology: ≥ CTCAE grade 3 neutropenia (ANC <1.0x10^9/L); ≥ CTCAE grade 3 thrombocytopenia (platelets <50x10^9/L); ≥ CTCAE grade 3 anemia (Hgb <80 g/L); Febrile neutropenia (ANC <1x10^9/L, fever ‡ 38.5°C), Renal: ≥ CTCAE grade 3 serum creatinine (>3xULN), Hepatic: ≥ CTCAE grade 3 total bilirubin (>3xULN); ≥ 10xULN ALT elevation; grade 2 total bilirubin (>1.5ULN) together with ≥ grade 3 ALT elevation (>5xULN), Cardiac: ≥ CTCAE grade 3, Other AEs: ≥ CTCAE grade 3 vomiting or nausea despite optimal antiemetic therapy, diarrhea despite optimal antidiarrheal treatment.|Baseline, End of dose escalation part (Day 42)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.||participants|||Number
68242|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the PMM subgroup and reported average of ≥3 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.||Days per month||Standard Error|Mean
68243|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.||Days per month||Standard Error|Mean
68244|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.||Days per month||Standard Error|Mean
68245|NCT01125774|Secondary|Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.||Days per month||Standard Error|Mean
68246|NCT01125774|Primary|Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.||Days per month||Standard Error|Mean
68298|NCT01125098|Secondary|To Verify Changes in FEV1 Value in COPD Patients Comparing Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|COPD patients of the study population will undergo spirometry on visit 1, 4, 5, 7 in order to evaluate if there is change in FEV1 among COPD patients, both in the PRO-CT Group and in the standard Group.|Discharge/10 days-6 months||11/2014||||
68247|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
68248|NCT01125774|Primary|Number of Participants With Laboratory AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
68249|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 6 months|APaT population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
68250|NCT01125774|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 14 days after the last dose of study drug (Up to 6.5 months)|All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.||Participants|||Number
68251|NCT01125748|Secondary|Time to the First Protocol-defined Severe Exacerbation|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.||Weeks||95% Confidence Interval|Mean
68252|NCT01125748|Primary|Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.||Percentage of participants||95% Confidence Interval|Number
68253|NCT01125722|Secondary|Change in Mean Overactive Bladder Symptom Composite Score|The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||scores on a scale||Standard Deviation|Mean
68299|NCT01125098|Secondary|To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the number of deaths from any cause among COPD patients in the study population, in order to compare survival among patients both in PRO-CT group and in the standard group.|Discharge/10 days-6 months||11/2014||||
68254|NCT01125722|Secondary|Change in Mean Urgency Episodes Per Day|Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||number of urgency episodes per 24 hours||Standard Deviation|Mean
68255|NCT01125722|Secondary|Change in Mean Volume Per Void|Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||mL||Standard Deviation|Mean
68256|NCT01125722|Secondary|Change in Mean Daily Voiding Frequency|Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||number of voids per 24 hours||Standard Deviation|Mean
68257|NCT01125722|Primary|Change in Mean Daily Urgency Incontinence Episodes|Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.||number of incontinence episodes/24 hours||Standard Deviation|Mean
68258|NCT01125605|Primary|Tolerability After Visit 2 and Visit 3|Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects|appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured||participants|||Number
68259|NCT01125605|Primary|Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation|The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits||participants|||Number
68260|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.~The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values||participants|||Number
68261|NCT01125605|Primary|Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation|The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits||participants|||Number
68262|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.~The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories “PASCONAL® better”, “No difference” and “PASCONAL® worse”."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values||participants|||Number
68263|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
68264|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
68484|NCT01123928|Primary|Decision to Undergo Cataract Surgery (Surgery Acceptance)|Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.||percentage of participants|||Number
68265|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment|"The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
68266|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication|The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories “improved”, “unchanged” and “worsened”. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values||participants|||Number
68267|NCT01125605|Secondary|Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration|"The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).~Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)"|begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))|exploratively, all participations with values||units on a scale||Standard Deviation|Mean
68268|NCT01125605|Primary|Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3|The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits||units on a scale||Standard Deviation|Mean
68269|NCT01125566|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death irrespective of the cause of the death.~For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date."|From randomisation to data cut-off (03Sep2013); Up to 37 months.|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not||months||Inter-Quartile Range|Median
68270|NCT01125566|Secondary|Best RECIST Assessment|"Best RECIST assessment is defined as CR, PR, stable disease (SD), PD or not evaluable by investigator (RECIST version 1.1).~CR for target lesions (TL): Disappearance of all target lesions.~CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Data collected until cut-off date 08Jun2013; Up to 34 months)|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not (One centre was excluded from analysis due to serious non-compliance, thus data from 5 patients in AV arm and 1 patient in TV arm were excluded)||percentage of participants|||Number
68271|NCT01125566|Secondary|Objective Response (OR)|"OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to RECIST 1.1.~Only data collected until the cut-off date 08Jun2013 were considered. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.~Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis)~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR"|Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Up to 34 months)|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not (One centre was excluded from analysis due to serious non-compliance, thus data from 5 patients in AV arm and 1 patient in TV arm were excluded)||percentage of participants||95% Confidence Interval|Number
68272|NCT01125566|Primary|Progression-free Survival (PFS)|"PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).~Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.~Progression of disease was determined if at least 1 of the following criteria applied:~At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm~Appearance of 1 or more new lesions~Unequivocal progression of existing non-target lesions"|From randomization until disease progression, death or data cut-off (08Jun2013); Up to 34 months|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not||months||Inter-Quartile Range|Median
68677|NCT01121666|Secondary|Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts||Day 1, 2, 3 and 5 of OPU/fertilisation|Intention to treat population||Patients with cryopreservation|||Number
68274|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.||mL/mg||Standard Deviation|Mean
68275|NCT01125514|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure was measured three times at 1 to 2-minute intervals. The mean of the three sitting blood pressure measurements was used as the average of the sitting office blood pressure. The msSBP and msDBP data were analyzed using a mixed effect model with fixed effects from treatment and treatment*time; random effect from patients and predose as covariate.|0.5 hour pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose.|Safety analysis set include subjects that received study drug.||mmHg||Standard Error|Least Squares Mean
68276|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 24 Hours Postdose|Urine was collected 24 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 24 hours.|24 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
68277|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 12 Hours Postdose|Urine was collected 12 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 12 hours.|12 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
68278|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 8 Hours Postdose|Urine was collected 8 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 8 hours.|8 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
68279|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 4 Hours Postdose|Urine was collected 4 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 4 hours.|4 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol||Standard Deviation|Mean
68280|NCT01125514|Secondary|Creatinine Clearance|Creatinine clearance= (Urine creatinine/Serum creatinine) x (Urine volume/(24*60)).|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.||mL/min||Standard Deviation|Mean
68281|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Renal Clearance (CLR)|The renal clearance of drug [volume x time-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.||L/h||Standard Deviation|Mean
68282|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Amount of Drug Excreted Into the Urine From Time Zero to 24 Hours After Administration (Ae0-24)|The area under the plasma (or serum or blood) concentration-time curve from time zero to 24 h [mass × time × volume-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set||mg||Standard Deviation|Mean
68283|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin, ss)|The minimum observed steady-state drug concentration in the plasma, blood, serum, or other body fluids at the end of the dosing interval during multiple dosing [amount x volume-1]|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set||ng/mL||Standard Deviation|Mean
68284|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Average Steady State Plasma Concentration During Multiple Dosing (Cav,ss)|The average steady-state drug concentration in the plasma, blood, serum, or other body fluids during multiple dosing [amount x volume-1]. This was estimated as AUCτ/τ|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All subjects with evaluable pharmacokinetic parameter data with no exclusion flags and no major protocol deviations.||ng/mL||Standard Deviation|Mean
68285|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Tmax was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set||Hours||Full Range|Median
68286|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)|Cmax,ss was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set||ng/mL||Standard Deviation|Mean
68300|NCT01125098|Secondary|To Evaluate if the PRO-CT-guided Decision Making to Shorten Antibiotic Therapy is Less Effective Than the Guideline Recommended Standard Antibiotic Treatment in Preventing Hospitalization.|We evaluate the number of hospital re-admissions for severe COPD exacerbation in COPD patients of the study population, both in the PRO-CT group and in the standard group, in order to assess if shortening antibiotic therapy taking into account the values of PRO-CT is less effective compared to a standard antibiotic treatment.|Discharge/10 days-6 months||11/2014||||
68287|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Area Under the Plasma Concentration-time Curve (AUC)|"Pharmacokinetic (PK) parameters were determined from the plasma concentration time profile of furosemide using a non-compartmental method:~AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval~AUC (0-24): Area under the plasma concentration-time curve from time zero to 24 hours~AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated as the sum of linear trapezoids using non-compartmental analysis.~AUCinf: Area under the plasma concentration-time curve from time zero to infinity. AUCinf was calculated by adding AUClast and the value obtained from dividing the last measurable plasma concentration by λz, where λz was determined from automated linear regression of the last three time points with non-zero concentrations in the terminal phase of the log-transformed concentration-time profile"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable Pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set.||h*ng/mL||Standard Deviation|Mean
68288|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol/mg||Standard Deviation|Mean
68289|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 4 hour urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.||mmol/mg||Standard Deviation|Mean
68290|NCT01125189|Secondary|Percentage of Resistant Variants Associated With Virologic Failure|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow­up, after HCV RNA < LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome."|Follow-up Week 48|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants|||Number
68291|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)|SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Follow-up Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
68292|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
68293|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 4|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
68294|NCT01125189|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (day 1) up to follow-up Week 48|All treated participants.||participants|||Number
68295|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)|SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
68296|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.|Weeks 4 and 12|All treated participants. Here, 'number of participants' analyzed (N) signifies number of participants evaluable for this outcome measure.||percentage of participants||80% Confidence Interval|Number
68297|NCT01125098|Secondary|To Verify the Duration of Hospitalization for Severe Exacerbation in COPD Patients Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the duration in days in case of hospitalization for severe COPD exacerbation in COPD patients in the study population, both in the PRO-CT-guided antibiotic treatment group and in the standard antibiotic treatment group.|Discharge/10 days-6 months||11/2014||||
68302|NCT01125098|Primary|To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy.|We prospectively recruited COPD patients hospitalized for severe exacerbation of COPD and followed them after discharge. The primary end point of the study was the number of patients with at least 1 exacerbation at 6 months after the index exacerbation that was the reason for their hospital admission.|6 months|||participants|||Number
68303|NCT01124955|Secondary|Number of Anti-inflammatory Tablets Taken|Number of 50 mg sodium diclofenac pills taken per day|Days 3,7,14,21 and 28|Intention to treat (ITT)||number of pills/day||Standard Deviation|Mean
68304|NCT01124955|Secondary|Likert Improvement Assessment Scale|Likert improvement assessment scale is based on the patient’s opinion (LIKERT P) and assessor’s opinion (LIKERT A), categorized in 1=MB (much better), 2=SB (slightly better), 3=NC (no change), 4=SW (slightly worse) and 5=MW (much worse). This scale was was applied to each day of assessment. The numbers in the category titles represent the different days.|Days 0, 3, 7, 14 and 21|||scores on a scale||Standard Deviation|Mean
68305|NCT01124955|Secondary|Quality of Life Assessed on the SF-36|Questionnaire Short-form-36 is a widely used generic health status questionnaire, validated for Portuguese with eight components and each components with scores from 0 to 100: higher scores denote greater quality of life.|Days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)||scores on a scale|Participants|Standard Deviation|Mean
68306|NCT01124955|Secondary|Roland-Morris Disability Questionnaire (RM)|"Secondary outcomes includes the Roland-Morris Disability Questionnaire (RM) for the assessment of functional capacity, with 24 items on low-back pain: higher scores denote poorer functional capacity.~0: better functional capacity 24: poorer functional capacity Range of score: the highest is 24 (poorer functional capacity) and lowest scores is 0 (better functional capacity)."|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)||scores on a scale|Participants|Standard Deviation|Mean
68307|NCT01124955|Primary|Pain Assessed on a 10-point Numeric Pain Scale|The primary outcome is a visual analog pain scale (VAS), graded in centimeters from 0 to 10 (0=no pain; 10=worst imaginable pain), measured before (VAS 1) and after (VAS 2) the acupuncture session.|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)||cm|Participants|Standard Deviation|Mean
68308|NCT01124916|Secondary|Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms.|6 Months|The analysis excludes three individuals assigned to the LASC cohort and two individuals assigned to the RASC cohort because they were lost to follow-up six months after intervention.||units on a scale||Standard Deviation|Mean
68309|NCT01124916|Primary|Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.|6 Weeks|The analysis for the primary outcome includes all randomized subjects.||Dollars||Standard Deviation|Mean
68310|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: Cmax|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for concentration max. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.||ng/mL||Standard Deviation|Mean
68311|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUClast|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve last. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.||h*ng/mL||Standard Deviation|Mean
68312|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUCinf|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve infinity. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.||h*ng/mL||Standard Deviation|Mean
68313|NCT01124864|Secondary|Progression Free Survival (PFS) Rate as Per Investigator Using Kaplan Meier Estimates - Per Investigator Radiological Review|Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment. A Novartis modified response evaluation criteria in solid tumors RECIST 1.1 criteria was applied to CT/MRI imaging data when assessing any responses to AUY922 treatment. All images were evaluated locally by the investigator. All complete or partial responses were confirmed by a second assessment at least 4 weeks later.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.||Percentage of participants|||Number
68314|NCT01124864|Secondary|Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review|Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.||Percentage of participants|||Number
68363|NCT01124604|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was addressed by the question: How long did you sleep last night? and the change from Baseline in time slept was reported."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Hours||Standard Deviation|Mean
68315|NCT01124864|Primary|Response Assessment by Study Stratum - Per Investigator Assessment|The primary endpoint of the study was the investigator assessment of efficacy at 18 weeks in terms of response complete response (CR)/partial response (PR), stable disease (SD), or non clinical benefit (NCB) as assessed by response evaluation criteriain solid tumors (RECIST) version 1.0. ORR = patients with confirmed complete or partial response. Stable disease at 18 weeks = patients without response and with no assessment of progressive disease up to 18 weeks, but with an assessment of stable disease or better either within 2 weeks prior to the 18 week time point, or at the next non-missing assessment after the 18 week time point. No clinical benefit = all other patients.|18 weeks|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.||Participants|||Number
68316|NCT01124838|Secondary|Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
68317|NCT01124838|Secondary|Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The near vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
68318|NCT01124838|Secondary|Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
68319|NCT01124838|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
68320|NCT01124838|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.|Central retinal thickness was measured using OCT and assessed by a central reader.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||percent change||Standard Deviation|Mean
68321|NCT01124838|Secondary|Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 2 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline||months||Inter-Quartile Range|Median
68322|NCT01124838|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||logMAR||Standard Deviation|Mean
68323|NCT01124838|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured."|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
68324|NCT01124838|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell~Grade 0.5+ = 1 - 5 cells~Grade 1+ = 6 - 15 cells~Grade 2+ = 16 - 25 cells~Grade 3+ = 26 - 50 cells~Grade 4+ = > 50 cells."|Baseline and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
68325|NCT01124838|Primary|Time to Treatment Failure on or After Week 2|"Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits:~New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline~2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline.~Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 3 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.||months||Inter-Quartile Range|Median
68326|NCT01124786|Secondary|Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling||30 days after first dose|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
68327|NCT01124786|Secondary|Change From Baseline in Health Status||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
68328|NCT01124786|Secondary|Change From Baseline in Pain Severity||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
68329|NCT01124786|Secondary|Drug Tolerability and Toxicity||Every week, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
68330|NCT01124786|Secondary|Cancer Antigen (CA)19-9 Response Rates||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
68331|NCT01124786|Secondary|ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years||Every 8 weeks|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
68332|NCT01124786|Secondary|Overall Survival in All Patients and Patients With hENT1 Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.|||||
68333|NCT01124786|Primary|Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years.|Analysis was per protocol and included hENT-1 low Intent to Treat (IIT) population.||months||95% Confidence Interval|Median
68334|NCT01124643|Primary|Safety Evaluations||Baseline to 12 months|ITT population||participants|||Number
68335|NCT01124643|Secondary|Change From Baseline in Albumin/Creatinine (A/Cr) Ratio||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||Ratio||Standard Deviation|Mean
68336|NCT01124643|Secondary|Change From Baseline in eGFR||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||(mL/min/1.73m^2)||Standard Deviation|Mean
68337|NCT01124643|Secondary|Change From Baseline in Plasma Gb3||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||(nmol/mL)||Standard Deviation|Mean
68338|NCT01124643|Secondary|Change From Baseline in New York Heart Association (NYHA) Functional Class|"Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea.~Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline to 12 months|ITT population.||participants|||Number
68339|NCT01124643|Secondary|Change From Baseline in the Minnesota Living With Heart Failure Questionnaire (MLHF- Q)|The MLHF-Q contains 21 questions with answers ranging from 0 (no) to 5 (very much). The final score ( 0 to 105) is the sum of the points for the 21 questions. A higher score indicates a worse quality of life.|Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.||units on a scale||Standard Deviation|Mean
68340|NCT01124643|Secondary|Change From Baseline in Distance Walked in 6- Minute Walk Test (6MWT)||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.||meters||Standard Deviation|Mean
68341|NCT01124643|Secondary|Change From Baseline in Maximal Oxygen Consumption (VO2max) at Peak Exercise||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.||(mL/min/kg)||Standard Deviation|Mean
68342|NCT01124643|Primary|Change From Baseline in Left Ventricular Mass Indexed to Height (LVMI)||Baseline to 12 months|The Intent-to-Treat (ITT) participant population in this study was defined as all participants who provided informed consent and received study drug. Participants who did not have left ventricular hypertrophy were not included in this analysis.||g/m^2.7||Standard Deviation|Mean
68678|NCT01121666|Secondary|Embryo Quality: Mean Number of Blastomeres|"Main embryo quality parameter mean number of blastomeres"|Day 2 of OPU/fertilisation|Intention to treat population||Number of blastomeres at day 3||Standard Deviation|Mean
68343|NCT01124617|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68344|NCT01124617|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|Participants rated the overall quality of sleep last night as excellent, good, fair and poor.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68345|NCT01124617|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was related to How many times did the participant wake up during the night”. Lesser number signifies better sleep."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68346|NCT01124617|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was related to How long did the participant sleep last night. The mean change for the time in hours slept during the last night was reported."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Hours||Standard Deviation|Mean
68347|NCT01124617|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was related to “How long after bedtime or lights out did the participant fall asleep last night . Decrease in time indicates an improvement."|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Minutes||Standard Deviation|Mean
68348|NCT01124617|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68349|NCT01124617|Secondary|Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent [no pain]) to 10 (extreme [pain as bad as you can image]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68350|NCT01124617|Secondary|Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68351|NCT01124617|Secondary|Number of Participants With Categorical Scores on Physician’s Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and ineffective."|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68352|NCT01124617|Secondary|Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68353|NCT01124617|Secondary|Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)|Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.||Percentage of participants|||Number
68354|NCT01124617|Secondary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.||Units on a scale||Standard Deviation|Mean
68355|NCT01124617|Primary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.|Baseline and Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
68356|NCT01124604|Other Pre-specified|Serum Concentration of Tapentadol||Week 2, 4, 8, 12|Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 serum study drug concentration. 'N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||nanogram per milliliter||Standard Deviation|Mean
68357|NCT01124604|Other Pre-specified|Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)|COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.|Week 12|Safety population included all the participants who received at least 1 dose of the study drug.||Participants|||Number
68358|NCT01124604|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12|RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as “Yes”/“No” where “Yes” is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68359|NCT01124604|Secondary|Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12|WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68360|NCT01124604|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68361|NCT01124604|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|"Overall quality of sleep was addressed by the question: Please rate the overall quality of your sleep last night” and participants could choose one of the following options: excellent, good, fair or poor."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68362|NCT01124604|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was addressed by the question: How many times did you wake up during the night?'' and lesser number signified better sleep."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68426|NCT01124175|Secondary|AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
68364|NCT01124604|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was addressed by the question: How long after bedtime/lights out did you fall asleep last night? and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Minutes||Standard Deviation|Mean
68365|NCT01124604|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12|BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
68366|NCT01124604|Secondary|Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68367|NCT01124604|Secondary|Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: “Do you have any pain today other than everyday kinds of pain?” on a 2-point scale of “yes” or “no”.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68368|NCT01124604|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and not effective."|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68369|NCT01124604|Secondary|Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
68370|NCT01124604|Secondary|Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)|Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.||Percentage of participants||95% Confidence Interval|Number
68371|NCT01124604|Secondary|Change From Baseline in 11-point Numerical Rating Scale (NRS)|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. LOCF method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
68372|NCT01124604|Primary|Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.||Units on a scale||Standard Deviation|Mean
68373|NCT01124448|Secondary|Evidence of Changes in the Immunological Profile of Milk||one year||||||
68374|NCT01124448|Secondary|Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk||One year||||||
68375|NCT01124448|Secondary|Evidence of Changes in the Metabolic Profile of Urine||One year||||||
68376|NCT01124448|Secondary|Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples||one year||||||
68377|NCT01124448|Primary|Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts|Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk|one week|||log10 CFU/mL||95% Confidence Interval|Mean
68378|NCT01124422|Secondary|Baseline Dyspnea Index (BDI) at Week 4 and Transition Dyspnea Index (TDI) at Week 8|The BDI-TDI is a multidimensional dyspnea measurement. The BDI, administered at Week 4, consisted of 3 items (functional impairment, magnitude of task in exertional capacity, and magnitude of effort) requiring recall over the previous 4 weeks. BDI scores ranged from 0 (very severe impairment) to 4 (no impairment); the summed total score = 0 to 12. The TDI, administered at Week 8 as a follow-up of the BDI, consisted of the same 3 items requiring recall over the previous 4 weeks. TDI scores ranged from -3 (major deterioration) to +3 (major improvement); the summed total score = -9 to 9.|BDI: Week 4; TDI: Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||Standard Error|Mean
68379|NCT01124422|Secondary|Mean Change in Scores on the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS) Questionnaire From Week 4 to Week 8|The CRQ-SAS, a self-administered tool used to assess health-related quality-of-life (HRQOL), consists of 20 questions (q.) in 4 domains: Dyspnea (5 q.), Fatigue (4 q.), Emotional Function (7 q.), and Mastery (4 q.). Participants rated their experience on a 7-point scale in response to each q.: 1 (maximum impairment) to 7 (no impairment); higher scores indicate better HRQOL. Individual q. were equally weighted, and domain scores (range=1-7) were calculated as the mean across the non-missing items within each domain (domain scores were calculated although an individual item score was missing).|Week 4 and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||Standard Error|Mean
68380|NCT01124422|Secondary|Mean Change in EIC at 2 to 3.5 Minutes During the Exercise Period From Baseline (Week 3) to Week 8|The EIC was measured at 2 to 3.5 minutes during the exercise period. Change from Baseline in EIC was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL||Standard Error|Mean
68381|NCT01124422|Secondary|Mean Change in Ratio of Respiratory Rate (RR) to Tidal Volume (VT) or RR/VT at Isotime During the Course of the ESWT From Baseline to Week 8|The RR and VT of the participants at isotime were measured during the ESWT using the OMS. The ratio of RR per VT (value of RR divided by value of VT) at isotime was calculated. Change from Baseline in RR/VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||breaths/min/L||Standard Error|Mean
68382|NCT01124422|Secondary|Mean Change in HR Per Time Slope During the Course of the ESWT Using Pulse Oximetry From Baseline to Week 8 (Non-OMS Subgroup)|HR was measured during the course of the ESWT in the non-OMS subgroup using pulse oximetry. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the ESWT. HR per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in HR was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed. A subgroup of participants specified sites provided cardio-respiratory and exercise IC measurements with the Oxycon Mobile System (OMS). Participants not at these sites formed the non-OMS subgroup.||bpm/min||Standard Error|Mean
68383|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) at Isotime During the Course of the ESWT From Baseline to Week 8|VT is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied. The normal value is approximately 500 mL or 7 mL/kg body weight. The VT of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||L||Standard Error|Mean
68384|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) Per Time Slope During the Course of the ESWT From Baseline to Week 8|VT is the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 mL or 7 mL/kg body weight). VT was measured during the ESWT using the OMS, consisting of volume transducer O2 and CO2 sensors and allowing breath-by-breath measurement of pulmonary gas exchange parameters. The participant's VT per time slope was calculated by fitting a linear regression line (RL) to their VT during the ESWT. VT per time slope results were compared between treatment groups as means of these RLs.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||L/min||Standard Error|Mean
68385|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) at Isotime During the Course of the ESWT From Baseline to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in RR at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||breaths/min||Standard Error|Mean
68386|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants was measured during the ESWT using the OMS. The system consisted of volume transducer oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The RR per time slope was calculated for each participant by fitting a linear regression line to the RR recorded for each participant during the ESWT. RR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||breaths/min/min||Standard Error|Mean
68387|NCT01124422|Secondary|Mean Change in Respiratory Exchange Ratio (RER) Per Time Slope During the Course of the ESWT From Baseline to Week 8|The respiratory exchange ratio was calculated as the ratio of VCO2 and VO2. The ratio of the amount of carbon dioxide and oxygen in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. Change from Baseline in RER was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Ratio of VCO2 and VO2||Standard Error|Mean
68388|NCT01124422|Secondary|Mean Change in Heart Rate (HR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|HR is defined as the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). It was measured during the ESWT using the OMS. The HR was collected in units of bpm and then regressed over the conduct of the exercise test measured in minutes. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the exercise test. HR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||bpm/min||Standard Error|Mean
68389|NCT01124422|Secondary|Mean Change in Minute Ventilation (V'E) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'E was measured in the participants during the ESWT using the OMS. The system consisted of a volume transducer, oxygen sensor, and carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'E was collected in liters and then regressed over the conduct of the exercise test measured in minutes. The V'E per time slope was calculated for each participant by fitting a linear regression line to the V'E recorded for each participant during the ESWT. V'E per time slope results were compared between treatment groups as means of the regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Liter (L)/min||Standard Error|Mean
68390|NCT01124422|Secondary|Mean Change in Flow of Carbon Dioxide (V'CO2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The amount of CO2 in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of a carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'CO2 per time slope was calculated for each participant by fitting a linear regression line to the V'CO2 recorded for each participant during the ESWT. V'CO2 per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in V'CO2 per time slope was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL/min||Standard Error|Mean
68391|NCT01124422|Secondary|Mean Change in Flow of Oxygen (V'O2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'O2 was measured during the ESWT using the Oxycon Mobile System (OMS), a portable telemetric monitoring system consisting of an oxygen sensor allowing for breath-by-breath measurement of gas exchange parameters in the lungs. The V'O2 was collected in units of mL and then regressed over the conduct of the exercise test measured in minutes. The V'O2 per time slope was calculated for each participant (par.) by fitting a linear regression line to the V'O2 recorded for each par. during the ESWT. V'O2 per time slope results were compared between treatment groups as means of these regression lin|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL/minute (min)||Standard Error|Mean
68392|NCT01124422|Secondary|Mean Change in Exercise Inspiratory Capacity (EIC) at the End of Exercise From Baseline (Week 3) to Week 8|EIC is the volume of gas that can be taken into the lungs in a full inhalation during exercise. Participants were asked to undergo the IC test every 2 minutes during exercise and at the end of the exercise, to follow changes in operational lung volumes that occured in association with exercise. Change from Baseline in EIC was calculated as the value at the end of exercise at Week 8 minus the value at the end of exercise at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||mL||Standard Error|Mean
68393|NCT01124422|Secondary|Mean Change in Pre-dose and Post-dose Resting Inspiratory Capacity (IC) From Baseline (Week 4) to Week 8|Resting IC is the volume of gas that can be taken into the lungs in a full inhalation at the resting position. The resting IC was measured before and after dosing. Change from Baseline in pre-dose resting IC was calculated as the pre-dose value at Week 8 minus the pre-dose value at Week 4. Change from Baseline in post-dose resting IC was calculated as the post-dose value at Week 8 minus the pre-dose value at Week 4.|Baseline (Week 4) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Milliliters (mL)||Standard Error|Mean
68394|NCT01124422|Secondary|Mean Change in EDS at Isotime From Baseline (Week 3) to Week 8|EDS at isotime (last common time point for an exercise assessment [i.e., last Borg score time point of the shortest exercise test for each participant]) was assessed using a 10-point modified Borg scale. Change from Baseline in EDS at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale||Standard Error|Mean
68395|NCT01124422|Secondary|Mean Change in Scores on the Exercise Dyspnea Scale (EDS) From Baseline (Week 3) to Week 8|EDS is used to measure the level of breathlessness due to exercise, assessed using a 10-point modified Borg scale at 2-minute intervals during the ESWT: 0=no difficulty in breathing at all, 10=maximal breathing difficulty (BD). The participant pointed to the level on the scale correlating with his BD, and the local study coordinator confirmed that level verbally to him. Change from Baseline was calculated as the value at Week 8 minus the value at Baseline. A dyspnea score/time slope was calculated by fitting a linear regression line to the dyspnea scores reported during the exercise tests.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Scores on a scale/minute||Standard Error|Mean
68396|NCT01124422|Primary|Mean Change in Exercise Endurance Time (EET) From Baseline (Week 3) to Week 8|EET is defined as the time taken by a participant to exert himself during an exercise. EET was calculated based on the Endurance Shuttle Walk test (ESWT). The ESWT is a standardized, externally controlled, constant-paced field test for the assessment of endurance capacity in participants with chronic lung disease. Change from Baseline in EET was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to study drug. Only those participants contributing data at the indicated time points were analyzed.||Seconds (sec)||Standard Error|Mean
68427|NCT01124175|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
68397|NCT01124370|Secondary|NYHA Functional Class Improvement From Baseline to 6 Months|"Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.~NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.~NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases."|Baseline and 6 months on therapy|Heart failure subjects with 6 month data.||participants|||Number
68398|NCT01124370|Secondary|Six-minute Hall Walk Test Change From Baseline at 6 Months|Change = Month 6 score - Baseline score|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.||meters||Standard Deviation|Mean
68399|NCT01124370|Secondary|Heart Failure Clinical Composite|"The composite is determined according to the following definitions.~Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF.~Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward.~Unchanged: patient was neither improved nor worsened."|6 months on therapy|Evaluable subjects with heart failure at baseline.||participants|||Number
68400|NCT01124370|Secondary|Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months|Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life.|Baseline and 6 months on therapy|Heart failure subjects with baseline and 6 month results.||units on a scale||Standard Deviation|Mean
68401|NCT01124370|Secondary|Epworth Sleepiness Scale Change From Baseline at 6 Months|Change = Month 6 score - Baseline score The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.||units on a scale||Standard Deviation|Mean
68402|NCT01124370|Secondary|Related Adverse Events|The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.|Up to 2 years|Subjects with an implant attempt.||participants|||Number
68403|NCT01124370|Primary|AHI Change From Baseline at 3 Months|Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.|Baseline and 3 months on therapy|The evaluable population includes subjects who completed a 3 Month post therapy initiation visit.||events/hour||Standard Deviation|Mean
68404|NCT01124305|Secondary|Limb Alignment (Mechanical Axis)|"Alignment is measured on 4 month postoperative radiograph in degrees. The goal is a mechanical axis between and femur and tibia of 0 degrees. Varus alignment (bow-legged) is shown as a negative number in degrees away from 0. Valgus alignment (Knock-kneed) is expressed as a positive number in degrees away from 0."|4 months|All participants were x-rayed postoperatively to measure the mechanical axis of the leg in degrees.||degrees varus(-) or valgus(+)||Full Range|Mean
68405|NCT01124305|Secondary|Number of Instrument Trays Required||1 day|per protocol||number of trays||Standard Deviation|Mean
68406|NCT01124305|Secondary|Length of Each Surgical Step (in Seconds)|surgical exposure, tibial alignment and resection, femoral distal cut, extension gap balancing, sizing the femur, 4 finishing femoral cuts, posterior releases, patellar resection, trial components, tibial tray preparation, cleanup/ prep for cement, cementing femur, cementing tibia, cementing patella, and closure|1 day|per protocol||seconds||Standard Deviation|Mean
68407|NCT01124305|Primary|Length of Surgery|Time elapsed from skin incision to wound closure (in seconds)|1 day|per protocol||seconds||Standard Deviation|Mean
68408|NCT01124292|Primary|Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.|Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective|24 months|||scores on a scale||Standard Deviation|Mean
68409|NCT01124292|Primary|Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting.~Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
68428|NCT01124175|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
68679|NCT01121666|Secondary|Fertilisation Rate of Oocytes|Fertilisation rate was assessed|1 day after ovum pick-up|Intention to treat population||percentage of oocytes||Standard Deviation|Mean
68410|NCT01124292|Primary|Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored “CALL” button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance.~Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
68411|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.~Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.~Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.~Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.~Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months|||Navigation Errors||Standard Deviation|Mean
68412|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Completion Time)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.~Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.~Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.~Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.~Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
68413|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||pixel^2/1000||Standard Deviation|Mean
68414|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Completion Time)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
68415|NCT01124292|Primary|Information Transfer Rate (Percentage of Correctly Completed Commands)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months|||Percentage of correctly completed cmd(%)||Standard Deviation|Mean
68416|NCT01124292|Primary|Information Transfer Rate (ITR)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months|||bits per minute||Standard Deviation|Mean
68429|NCT01124175|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.||ng*h/mL||Standard Deviation|Mean
68417|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
68418|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
68419|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||seconds||Standard Deviation|Mean
68420|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
68421|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
68422|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
68423|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
68424|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||Percentage of Missed Targets (%)||Standard Deviation|Mean
68425|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months|||bits per second||Standard Deviation|Mean
68430|NCT01124175|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.||ng*h/mL||Standard Deviation|Mean
68431|NCT01124175|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.||ng/mL||Standard Deviation|Mean
68432|NCT01124162|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losaran Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
68433|NCT01124162|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
68434|NCT01124162|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
68435|NCT01124162|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
68436|NCT01124162|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
68437|NCT01124162|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
68438|NCT01124149|Secondary|Percentage of Subjects in Partial Remission at Week 8 of Acute Phase|"Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
68439|NCT01124149|Secondary|Percentage of Subjects in Complete Remission at Week 8 of Acute Phase|"Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 Weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
68440|NCT01124149|Secondary|Improvement in Stool Frequency Symptoms During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point.~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
68441|NCT01124149|Secondary|Improvement in Rectal Bleeding Score During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point.~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.||percentage of subjects|||Number
68442|NCT01124149|Secondary|Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase|"Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
68443|NCT01124149|Secondary|Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase|Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
68650|NCT01121900|Secondary|Apparent Terminal Elimination Rate Constant (λz)|The elimination rate constant of trazodone (Lamda z). It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. This constant is used in half-life calculations.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||1/hour||Standard Deviation|Mean
68444|NCT01124149|Secondary|Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase|"Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency.~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
68445|NCT01124149|Primary|Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase|"Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.||percentage of subjects|||Number
68446|NCT01124097|Primary|Change From Baseline to Endpoint in Mean Pain|"The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis.~The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [“0” = no pain; “10” = the most intense pain imaginable]"|baseline to endpoint|efficacy population||units on a scale||Standard Error|Least Squares Mean
68447|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation|Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68448|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia|Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68449|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity|Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68450|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis|Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68451|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon|Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68452|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis|Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68464|NCT01124006|Secondary|Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.|The Visual Analogue Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line ( that is approximately 10cm long) with 'No Pain' (score of 0=0cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
68453|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection|Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68454|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection|Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68455|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity|Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68456|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade|Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68457|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade|Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient had missing anterior cell grade assessment at all visits.||Percentage of patients|||Number
68458|NCT01124045|Secondary|Global Assessment Score of Postoperative Inflammation by Visit|A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.||Percentage of patients|||Number
68459|NCT01124045|Primary|Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days|Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.|Day 15 ± 2 days|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient (DUREZOL) had missing anterior cell grade assessment at all visits.||Percentage of patients|||Number
68460|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
68461|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population||participants|||Number
68462|NCT01124006|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the MCS, SF-36 at Baseline."||units on a scale||Standard Deviation|Mean
68463|NCT01124006|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the PCS, SF-36 at Baseline."||units on a scale||Standard Deviation|Mean
68465|NCT01124006|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12-month|FAS Population||units on a scale||Standard Deviation|Mean
68466|NCT01124006|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~For the Neurological Assessment at 12 months, only 8 subjects from the rhGDF-5 1.0mg group (out of 10 subjects total) completed the assessment, only 3 subjects from the rhGDF-5 2.0mg group (out of 4 subjects total) completed the assessment, and none of the placebo subjects (out of 10 total subjects) completed the assessment."||participants|||Number
68467|NCT01123980|Secondary|Number of Hypoglycaemic Episodes|All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).||episodes|||Number
68468|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - Severe and Minor|Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L.|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).||episodes|||Number
68469|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - All||Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).||episodes|||Number
68470|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage (%) of subjects|||Number
68471|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||percentage (%) of subjects|||Number
68472|NCT01123980|Secondary|9-point Plasma Glucose Profiles|Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day.|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).||mmol/L||Standard Error|Mean
68473|NCT01123980|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of trial product(s)||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
68474|NCT01123941|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 6-month period after vaccination|||participants|||Number
68475|NCT01123941|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination|||participants|||Number
68476|NCT01123941|Secondary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after vaccination|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
68477|NCT01123941|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.|During the 7-day period after vaccination|||participants|||Number
68478|NCT01123928|Secondary|"Belief That Doctors and Nurses at the Hospital Have Very Good Attitudes"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
68479|NCT01123928|Secondary|"Belief That Surgeons at the Hospital Are Highly Skilled"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
68480|NCT01123928|Secondary|"Belief That Vision Will Improve a Lot Following Surgery"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
68481|NCT01123928|Secondary|Belief That Surgery Will be Painful|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
68482|NCT01123928|Secondary|Knowledge That Cataract Can be Treated|Measured as a percentage of subjects who correctly answer the question in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.||percentage of respondents|||Number
68483|NCT01123928|Secondary|Attendance at Hospital for Pre-operative Examination|Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.||percentage of participants|||Number
68485|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|15 minutes prior to initial injection of corticosteroid versus platelet rich plasma|||units on a scale||Standard Deviation|Mean
68486|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|12 weeks from initial injection of corticosteroid versus platelet rich plasma|||units on a scale||Standard Deviation|Mean
68487|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|6 weeks from initial injection of corticosteroid versus platelet rich plasma|||units on a scale||Standard Deviation|Mean
68488|NCT01123850|Secondary|Outcome Measure - Pain, Life Quality, Satisfaction||PreOp, Surgery, 6M, 12M|Study was terminated due to slow enrollment, there was no data analysis|||||
68489|NCT01123850|Primary|Fusion Assessment|Fusion at 12M using radiograph Fusion Mass at 12M using CT|6 M, 12 M|Study was terminated due to slow enrollment, there was no data analysis|||||
68490|NCT01123642|Secondary|Clinician Administered PTSD Scale||one year||||||
68491|NCT01123642|Secondary|Quality of Life Scale||one year||||||
68492|NCT01123642|Secondary|Inventory of Psychosocial Recovery (IPR)||one year||||||
68493|NCT01123642|Primary|World Health Organization Disability Assessment Schedule II (WHODAS II)|Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.|one year|A total of 345 participants were enrolled, of which 309 were deemed eligible. Analyses are conducted with the total sample N = 309, followed over time.||units on a scale||Standard Deviation|Mean
68494|NCT01123512|Primary|Proportion of Participants With Study Success|"Patient success will be defined as:~Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),~Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and~Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation"|12 Month Post-op|||participants|||Number
68495|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.||ng-hr/mL||Standard Deviation|Mean
68496|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC (0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.||ng-hr/mL||Standard Deviation|Mean
68497|NCT01123395|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.||ng/mL||Standard Deviation|Mean
68498|NCT01123356|Secondary|Dose Reductions Due to Adverse Events.|Number of dose reductions due to toxicity.|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.||dose reductions|||Number
68499|NCT01123356|Secondary|Frequency of Adverse Events|Number of adverse events occuring in greater than 20% of subjects|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.||events|||Number
68500|NCT01123356|Secondary|Biomarkers Changes During Treatment.|Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.|30 Weeks|The biomarker sub-study was not completed due to poor accrual to this substudy and lack of feasibility.|||||
68501|NCT01123356|Secondary|Frequency of Adverse and Severe Adverse Events|Frequency of adverse and severe adverse events|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.||participants|||Number
68651|NCT01121900|Secondary|Time to Maximum Plasma Concentration (Tmax)||68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||Hours||Full Range|Median
68502|NCT01123356|Primary|Overall Response Rate|"Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).~Overall response rate was defined as those who experienced a response of CR, CRi or PR."|30 Weeks|Overall response rate is defined as response (CR, CRi or PR) at cycle 3 or cycle 6 evaluation. Only patients who completed at least 3 cycles were eligible for analysis for this outcome measure.||percentage of participants||95% Confidence Interval|Number
68503|NCT01123148|Primary|The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.|"Subjects will participate in 3 sessions. During each session each subject will copy a word in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days."|3 1-2 hour sessions over 2-4 weeks|||% Accuracy of selections||Standard Deviation|Mean
68504|NCT01122927|Secondary|Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)|The CGAS is a 100-point rating scale measuring psychological, social, and school functioning for children aged 6 to 17. It was adapted from the Adults Global Assessment Scale. The Global Assessment Scale was a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS Score (range 1 to 100) is a single-item score for rating a child’s general level of functioning on a health-illness continuum, with higher scores representing better functioning.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68505|NCT01122927|Secondary|Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score|The ADHD-RS-IV is a reliable and easy-to-administer instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. Containing 18 items, the scale was linked directly to DSM-IV-TR diagnostic criteria for ADHD. There were 3 versions of the scale: a parent questionnaire on home behaviors (English), a parent questionnaire on home behaviors (Spanish), and a teacher questionnaire on classroom behaviors. For this trial, the parent questionnaire on home behaviors (English) was utilized. The ADHD-RS-IV Total Score (range 0 to 54) is the sum of rating scores for 18 items, with higher scores representing greater severity. A missing value for any ADHD-RS-IV assessment items could have resulted in a missing ADHD-RS-IV Total Score. Data were only available for 82 participants with bipolar disorder and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68506|NCT01122927|Secondary|Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale|The GBI is a self-report inventory with 73 items focusing on mood-related behaviors, including depressive, hypomanic, and biphasic symptoms. For this trial, two 20-item subscales were utilized: one was completed by the parent/guardian or legal representative, as applicable for local laws, and the other was completed by the participant. Responses were given on a 4-point Likert scale, with 0 being never or hardly ever and 3 being very often or almost constantly. The GBI Total Score for mania (range 0 to 30) is the sum of scores for items 1 to 10 and the GBI Total Score for depression (range 0 to 30) is the sum of scores for items 11 to 20 in the GBI Parent/Guardian or Subject Version panel. Scores from the Parent/Guardian and participant Versions were summarized separately. A missing value for any GBI assessment items could have resulted in a missing GBI Total Score. High scores represent greater psychopathology. Data was only available for 80 de novo participants with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68507|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject’s Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Only 94 participants had data at Baseline to explain the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68508|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject’s Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Data for 94 de novo participants were available with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68509|NCT01122927|Secondary|Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score|The YMRS consists of 11 items assessing the core symptoms of mania and was used to assess participants with bipolar I disorder, manic and mixed episodes with or without psychotic features: elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech (rate and amount), language - thought disorder, content, disruptive - aggressive behavior, appearance, and insight. Each item had 5 or 9 grades of severity, with lower scores indicating milder symptoms. The number of raters within each trial center was to be kept to a minimum. The YMRS Total Score (range 0 to 44) is the sum of the rating scores for 11 items for assessing the core symptoms of mania. A missing value for any YMRS assessment item(s) could have resulted in a missing YMRS Total Score. A higher YMRS Total Score represents greater severity. In this study, 94 participants had bipolar disorder, this explains the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68510|NCT01122927|Secondary|Mean Change in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68511|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68512|NCT01122927|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68513|NCT01122927|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68514|NCT01122927|Secondary|Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68515|NCT01122927|Secondary|Percentage of Participants Who Discontinued Due to All Adverse Events|The percentage of participants who discontinued due to all causes other than sponsor terminating the trial was measured from the date of entering the open-label treatment phase to the date of ET for discontinued participants in the open-label treatment phase (ie, time to discontinuation = date of discontinuation [or date of completion for completed participants] − date of participant entering the open-label treatment phase + 1). If the participants completed the trial or were discontinued due to the sponsor terminating the trial, they were censored at the time of completion or trial termination, respectively.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||percentage of participants|||Number
68516|NCT01122927|Secondary|Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The below reported N value is the number of participants with specified suicidal ideation/behavior at the given time point.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
68517|NCT01122927|Secondary|Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68518|NCT01122927|Secondary|Baseline and Post-Baseline Tanner Staging|Tanner staging was completed together with the physical examination by the same trial-affiliated clinician in the most inconspicuous manner for the participant as possible. Tanner staging assessment consisted of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. A participant who reached Stage 5 (both in pubic hair and genitalia) did not need to continue with Tanner Staging assessment and the Tanner Staging scales of this participant were imputed as 5 for all of the following scheduled time points up to and including the completion visit/ET visit. The clinician arrived at a single score summarizing the domains (not individual domain scores) when evaluating the participant. The total shift data for last visit is presented below.|Baseline to Last Visit|All those participants who had received at least one dose of oral aripiprazole during the open-label treatment phase.||participants|||Number
68519|NCT01122927|Secondary|Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)|The NY-AACENT is not a validated scale. It was included in this trial because of concerns that regulatory authorities (the European Committee for Medicinal Products for Human Use [CHMP] and the Paediatric Sub-Committee of the European Medicinal Agency [PDCO]) had regarding drug induced cognitive impairment. No validated scale addressing these issues was available at the time of the trial. The NY-AACENT was used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It was specifically designed to be used in pediatric populations (ages 12 to 17), but could have been utilized with other age groups, as appropriate.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
68520|NCT01122927|Secondary|Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score|The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68521|NCT01122927|Secondary|Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68522|NCT01122927|Secondary|Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||Units on a scale||Standard Deviation|Mean
68523|NCT01122927|Secondary|Incidence of Vital Signs of Potential Clinical Relevance|Vital signs are taken at Baseline, Weeks 1, 2, 3, 4, 6, 8, and Months 3, 4, 6, 9, 12, 15, 18, 21, 24 of Phase 2 (Visits beyond Month 12 only for de novo subjects). Assessments included orthostatic (supine and standing) blood pressure (BP), heart rate and body temperature. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Abnormal vital signs in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
68524|NCT01122927|Secondary|Incidence of Physical Examination Findings of Potential Clinical Relevance|The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole. Any clinically relevant abnormal changes were recorded as TEAEs.||participants|||Number
68525|NCT01122927|Secondary|Incidence of Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.||participants|||Number
68526|NCT01122927|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.|All participants who had received at least one dose of oral aripiprazole.||Participants|||Number
68652|NCT01121900|Secondary|Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)]||24 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||h*ng/mL||Standard Deviation|Mean
68527|NCT01122862|Secondary|Interproximal Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
68528|NCT01122862|Secondary|Interproximal Plaque Index After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
68529|NCT01122862|Secondary|Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
68530|NCT01122862|Secondary|Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
68531|NCT01122862|Primary|Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|Intention to Treat (ITT) population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.||Score on a scale||Standard Error|Mean
68532|NCT01122680|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and last week of treatment (week 4)|FAS with non-missing data for nighttime awakenings||Night awakenings per week||Standard Error|Least Squares Mean
68533|NCT01122680|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of a seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with non-missing ACQ data||Units on a scale||Standard Error|Least Squares Mean
68534|NCT01122680|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Day|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing data for rescue medication||Puffs/day||Standard Error|Least Squares Mean
68535|NCT01122680|Secondary|Mean Evening PEF Response|Mean evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing evening PEF data||Litre/min||Standard Error|Least Squares Mean
68536|NCT01122680|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing morning PEF data||Litre/min||Standard Error|Least Squares Mean
68537|NCT01122680|Secondary|Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point|FEF 25-75% is the mean forced expiratory flow between 25% and 75% of the FVC determined at the end of the 4-week treatment period. This is often referred to as the maximum midexpiratory flow. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEF data||Litre||Standard Error|Least Squares Mean
68538|NCT01122680|Secondary|FVC Individual Measurements at Each Time-point|"Individual FVC measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
68539|NCT01122680|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
68540|NCT01122680|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
68541|NCT01122680|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.||Litre||Standard Error|Least Squares Mean
68542|NCT01122680|Secondary|FEV1 Individual Measurements Response at Each Time-point|"Individual FEV1 measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
68543|NCT01122680|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
68544|NCT01122680|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
68545|NCT01122680|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period. This patient set is therefore FAS reduced to patients with non-missing FEV1 data.||Litre||Standard Error|Least Squares Mean
68546|NCT01122576|Secondary|Best-corrected Distance Visual Acuity|High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set||logMAR|Participants|Standard Deviation|Mean
68547|NCT01122576|Secondary|Uncorrected Distance Visual Acuity|High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set||logMAR|Participants|Standard Deviation|Mean
68548|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 4 (4-6 Months)|Full Analysis Set||Diopters|Participants|Standard Deviation|Mean
68549|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 3 (2-3 Months)|Full Analysis Set||Diopters|Participants|Standard Deviation|Mean
68550|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set||units on a scale||Standard Deviation|Mean
68551|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set||units on a scale||Standard Deviation|Mean
68552|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set||units on a scale|Participants|Standard Deviation|Mean
68553|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set||units on a scale|Participants|Standard Deviation|Mean
68554|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 4 (4-6 months)|||units on a scale|Participants|Standard Deviation|Mean
68680|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with ovum pick-up|34-36 hours after hCG administration|Intention to treat population||Participants|||Number
68555|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 3 (2-3 months)|Full Analysis Set||units on a scale|Participants|Standard Deviation|Mean
68556|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68557|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68558|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68559|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68560|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68561|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68562|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68563|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68564|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68565|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68566|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68567|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68568|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68569|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
91391|NCT00892957|Secondary|Percentage of Participants With Infection at the Surgical Site||post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set||percentage of participants||95% Confidence Interval|Number
68570|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68571|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68572|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68573|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68574|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68575|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68576|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68577|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68578|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68579|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units||Standard Deviation|Mean
68580|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full set analysis||log contrast sensitivity units||Standard Deviation|Mean
68581|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68582|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68583|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68584|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68585|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68586|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68587|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68588|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68589|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set||log contrast sensitivity units|Participants|Standard Deviation|Mean
68590|NCT01122511|Secondary|Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
68591|NCT01122511|Secondary|Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
68592|NCT01122511|Secondary|The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
68593|NCT01122511|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.|||||
68594|NCT01122394|Secondary|Antihypertensive/ Lipid-lowering Medication Adherence|Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent|6 months|One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis||units on a scale||Standard Deviation|Mean
68595|NCT01122394|Secondary|Exercise Adherence|Measured by 7-day Physical Activity Recall|6 months|||hours per week of cardio||Inter-Quartile Range|Median
68596|NCT01122394|Secondary|Total Cholesterol/High Density Lipoprotein Ratio||6 months|Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis||ratio||Inter-Quartile Range|Median
68597|NCT01122394|Secondary|Dietary Sodium|self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)|6 months|||participants|||Number
68598|NCT01122394|Primary|Systolic Blood Pressure||6 months|restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment||mm Hg||Inter-Quartile Range|Median
68599|NCT01122381|Primary|Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline.|"Compare number of migraine headache days pre and post treatment between the ESX and placebo group.~Study terminated early-no outcome data available. The single subject assigned to study drug did not actually take it according to subsequent review of ESX drug levels."|4 weeks, end of treatment and pre-treatment baseline||||||
68653|NCT01121900|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).~Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||h*ng/mL||Standard Deviation|Mean
68600|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Overall Relationship domain consists of 2 items (items 13-14), each rated on a scale of 1 (Never) to 5 (Always). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Overall Relationship observation.||units on a scale||95% Confidence Interval|Least Squares Mean
68601|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Self-Esteem domain consists of 4 items (items 9-12), each rated on a scale of 1 (Never) to 5 (Always). Item 11 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Self-Esteem observation.||units on a scale||95% Confidence Interval|Least Squares Mean
68602|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Confidence domain measures improvement in confidence; 2 subscales (6 items: Self-Esteem [items 9-12]; Overall Relationship [items 13-14]). Each item range: 1 (Never) to 5 (Always); item 11 reverse scored. Domain score=sum of domain's respective items, then transformed into 0 (least favorable) to 100 (most favorable) scale. Transformed score=100x[(actual raw score-lowest possible raw score)/possible raw score range]. Least Squares Mean change adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Confidence observation.||units on a scale||95% Confidence Interval|Least Squares Mean
68603|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. Transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Sexual Relationship observation.||units on a scale||95% Confidence Interval|Least Squares Mean
68604|NCT01122264|Secondary|Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)|The PAIRS is a 23-item scale that assesses broader psychological/interpersonal outcomes associated with erectile dysfunction and its treatment. Each question is rated on a Likert scale from 1 (strongly disagree) to 4 (strongly agree). The scale consists of 3 domains: Sexual Self-Confidence (items 1-6), Spontaneity domain (items 7-15), and Time Concerns (items 16-23). The average domain score for each domain was calculated by adding the nonmissing items for the respective domain, then dividing by the number of nonmissing items for the respective domain. Each average domain score ranged from 1 to 4. Higher scores represent the following: greater sexual self-confidence (better outcome); greater spontaneity (better outcome); higher time concerns (worse outcome). The Least Squares Mean changes were adjusted for treatment group, country, baseline IIEF-EF severity, baseline domain score, and baseline domain score*treatment (if p<0.10).|Baseline, 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline PAIRS observation.||units on a scale||95% Confidence Interval|Least Squares Mean
68605|NCT01122264|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks|The participant questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score was obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), then multiplying by 25, thus obtaining a score range from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). Least Squares Mean changes were adjusted for treatment group, country, visit, and visit*treatment.|4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline EDITS observation.||units on a scale||95% Confidence Interval|Least Squares Mean
68606|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction on the IIEF over past 4 weeks and consists of 2 questions (items 13 and 14), each rated on a scale from 1 (very dissatisfied) to 5 (very satisfied). Total scores range from 2 to 10; lower numerical scores represent lower overall satisfaction. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Overall Satisfaction observation.||units on a scale||Standard Error|Least Squares Mean
68617|NCT01122264|Primary|Time to Discontinuation of Randomized Treatment|Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.|Baseline up to 334 days|The analysis included all randomly assigned participants.||days||95% Confidence Interval|Median
68607|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction score over past 4 weeks (1 intercourse attempt item, 2 intercourse satisfaction items). Each item range: 0 (no intercourse attempts/no satisfaction) to 5 (more attempts/high satisfaction). Total scores range: 0-15; lower scores=lower intercourse satisfaction. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Intercourse Satisfaction observation.||units on a scale||Standard Error|Least Squares Mean
68608|NCT01122264|Secondary|Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments|The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study and not switching to another treatment) are reported by the median (95% confidence interval). Duration was measured as the number of days from Week 8 to the date of the last dose of the study drug. This outcome measure was estimated using the Kaplan-Meier product-limit method.|8 weeks up to 334 days|The analysis included all randomly assigned participants who completed the 8-week randomized treatment.||days||95% Confidence Interval|Median
68609|NCT01122264|Secondary|Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment|The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment.|Baseline through 24 weeks|The analysis included all randomly assigned participants.||participants|||Number
68610|NCT01122264|Secondary|Patterns of Erectile Dysfunction Treatment Change|Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported.|Baseline through 24 weeks|All randomly assigned participants were included in the analysis.||participants|||Number
68611|NCT01122264|Secondary|Number of Treatment Switches|The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand).|Baseline through 24 weeks|The analysis included all randomly assigned participants who switched erectile dysfunction medication and had a baseline and post-baseline observation.||number of treatment switches||Standard Deviation|Mean
68612|NCT01122264|Secondary|Global Assessment Questions (GAQ)|The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity?|24 weeks|The analysis included all randomly assigned participants. The last available GAQ assessment for each participant was used in the analysis.||participants|||Number
68613|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)|Participant-assessed diary. Has 5 questions (Question[Q]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEP observation.||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
68614|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Sexual Desire observation.||units on a scale||Standard Error|Least Squares Mean
68615|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Orgasmic Function observation.||units on a scale||Standard Error|Least Squares Mean
68616|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain|Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF-EF observation.||units on a scale||Standard Error|Least Squares Mean
68618|NCT01122238|Primary|Percent Change in Cigarettes Smoked Per Day (CPD)|"Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model.~Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces average number of cigarettes per day in the past week (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar."|Assessed at week 26 relative to baseline CPD.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.||Percent Change in cigarettes per day||Standard Deviation|Mean
68619|NCT01122238|Secondary|Average Number of Cigarettes Per Day in the Past Week.||Assessed at baseline and week 26.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.||Change in cigarettes per day||Standard Deviation|Mean
68620|NCT01122160|Primary|Gastric pH||1 hour prior to gastric emptying on Day 7 of the given intervention|||pH||Standard Deviation|Mean
68621|NCT01122108|Other Pre-specified|Weighted vs. Unweighted Composite BASA Scale Scores|Aggregate scores were calculated for both the unweighted and weighted BASA scale scores for both Colesevlam HCL (3.75G) and Cholestyramine (12g). The best possible total BASA score is 20 and the worst possible total BASA score is 4. For the weighted version of the scale, the best possible total score is 60 and the worst possible total score is 4.|1 Day|||Units on a BASA Scale||Standard Deviation|Mean
68622|NCT01122108|Primary|Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug.|The bile acid sequestrant acceptability (BASA) scale has 4 scoring categories: taste, texture, appearance, and mixability. Participants rank each category separately. The best possible score for each category is 5, and the worst possible score for each category is 1.|1 Day|||Units on BASA Scale||Standard Deviation|Mean
68623|NCT01121991|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation.|AEs: Any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. TEAEs: AEs that occur during treatment with the study drug. It also included incidences of mild, moderate and severe ovarian hyperstimulation syndrome (OHSS). SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit).|ITT population: all participants who received at least one dose of the study drug.||Number of participants|||Number
68624|NCT01121991|Secondary|Pregnancy Loss Per Clinical Pregnancy|Preclinical miscarriage: Spontaneous cessation of a biochemical pregnancy. Early spontaneous abortion: Any spontaneous abortion occurring after confirmation of clinical pregnancy and before completion of 12 weeks of gestation. Late spontaneous abortion: any spontaneous abortion occurring between completion of 12 weeks of gestation and prior to a viable stage. Pregnancy loss per clinical pregnancy was measured as a percentage.|Post-hCG days 35-42.|Participants with confirmed clinical pregnancies.||Percentage of pregnancy loss|||Number
68625|NCT01121991|Secondary|Number of Live Births|A live birth occurs when a fetus, whatever its gestational age, exits the maternal body and subsequently shows any sign of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord, for however brief a time and regardless of whether the umbilical cord or placenta are intact.|Post-hCG days 15-20 to pregnancy follow up.|ITT population: all participants who received at least one dose of the study drug.||Live births|||Number
68626|NCT01121991|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Post-hCG Day 35-42.|ITT population: all participants who received at least one dose of the study drug.||participants|||Number
68627|NCT01121991|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy: A positive pregnancy test defined as hCG level >10 IU/L in a sample taken at least 14 days after Day 3 embryo transfer or 12 days after Day 5/6 embryo transfer with no further ultrasound confirmation of the existence of a gestational sac in the uterus. Clinical pregnancy: Existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Post-hCG days 15-20 and post-hCG days 35-42.|ITT population: all participants who received at least one dose of the study drug.||participants|||Number
68628|NCT01121991|Secondary|Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up|Mean number of oocytes retrieved per number of follicles aspirated on the day of ovum pick up was calculated. Oocyte retrieval is a technique used in in vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|On day of ovum pick up (Day 1 or 2 after hCG administration)|ITT population: all participants who received at least one dose of the study drug and underwent vaginal ovum pick up.||oocytes per aspirated follicle||Standard Deviation|Mean
68629|NCT01121991|Primary|Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF)|Mean number of oocytes undergoing ovum pick up for IVF were calculated for each participant. IVF is a process by which egg cells are fertilized by sperm outside the body, in-vitro.|On the day of ovum pick up (Day 1 or 2 after hCG administration).|Analysis population includes those participants undergoing IVF whose oocytes were assessed for maturity. Mature oocytes can be considered as Metaphase II oocytes.||oocytes||Standard Deviation|Mean
68648|NCT01121913|Primary|Bioequivalence Based on AUC(0-t)|"AUC(0-t) = Area under the plasma concentration curve vs (versus) time data pairs, where t is the time of the last quantifiable concentration.~Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||ng*h/mL||Standard Deviation|Mean
68649|NCT01121900|Secondary|Apparent Terminal Half-life (t½.z)|The elimination half-life (T½z) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||Hours||Standard Deviation|Mean
68630|NCT01121991|Primary|Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI)|Mean number of metaphase II oocytes was calculated for each participant undergoing ovum pick up for ICSI. ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration).|Analysis population includes those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope.||Metaphase II Oocytes||Standard Deviation|Mean
68631|NCT01121939|Secondary|Disease Control Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.|18 months|Includes all patients||percentage of participants|||Number
68632|NCT01121939|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)||months||95% Confidence Interval|Median
68633|NCT01121939|Secondary|Progression-Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)||months||95% Confidence Interval|Median
68634|NCT01121939|Secondary|Define Toxicity and Safety|To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity|18 months|All patients on study||participants|||Number
68635|NCT01121939|Primary|Objective Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients||percentage of participants|||Number
68636|NCT01121926|Secondary|Percentage Peak-Trough Fluctuation (%PTF)|"Percentage Peak-Trough Fluctuation (%PTF) of trazodone calculated as [100*(Cmax-Cmin)/Cav].~Cmax: Maximum plasma concentration Cmin: Minimum plasma concentration Cav: Average plasma concentration"|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||Percentage Peak-Trough Fluctuation||Standard Deviation|Mean
68637|NCT01121926|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter calculated as follows:~((Cmax,ss - Cmin,ss)/Cmin,ss)*100.~Where:~Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.~It was calculated over 24 hours on day 9."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||Percentage swing||Standard Deviation|Mean
68638|NCT01121926|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure (Tmax) at steady state.|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||hours||Full Range|Median
68639|NCT01121926|Secondary|Plasma Concentration at 24 Hours Post-evening Dose (C24h)|Plasma concentration at 24 hours post-evening dose (C24h) in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
68640|NCT01121926|Secondary|Minimum Plasma Concentration (Cmin,ss)|Minimum plasma concentration at steady state (Cmin,ss). Measured in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
68641|NCT01121926|Primary|Bioequivalence Based on AUCss|"AUCss = Area under the plasma concentration curve (AUC) vs. time data pairs at steady state (ss): AUCss.~Measured in nanograms x hours per milliliter (ng*h/mL)."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng*h/mL||Standard Deviation|Mean
68642|NCT01121926|Primary|Bioequivalence Based on Cmax,ss|Cmax,ss = Maximum plasma concentration (Cmax) at steady state (ss): (Cmax,ss). Measured in nanograms per milliliter (ng/mL).|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
68643|NCT01121913|Secondary|Apparent First Order Terminal Rate Constant [λz]|Apparent First order terminal rate constant [λz] of trazodone in plasma expressed in 1/hours.|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||1/hours||Standard Deviation|Mean
68644|NCT01121913|Secondary|Time to the Maximum Concentration (Tmax)||72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||Hours||Full Range|Median
68645|NCT01121913|Secondary|Apparent Terminal Half-life (t½.z)|Apparent terminal half-life (t½.z) of trazodone in hours|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||Hours||Standard Deviation|Mean
68646|NCT01121913|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
68647|NCT01121913|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).~Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.||ng*h/mL||Standard Deviation|Mean
68673|NCT01121666|Secondary|Implantation Rate|Defined as fetal sac per embryo transferred.|Five to six weeks after oocyte retrieval|Intention to treat population.||Percentage of implantations|||Number
68654|NCT01121900|Primary|Bioequivalence Based on AUC(0-tlast)|"AUC(0-tlast) = Area under the plasma concentration curve (AUC) vs (versus) time data pairs, where tlast is the time of the last quantifiable concentration.~Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||hr*ng/mL||Standard Deviation|Mean
68655|NCT01121900|Primary|Bioequivalence Based Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.||ng/mL||Standard Deviation|Mean
68656|NCT01121757|Other Pre-specified|Serum Markers Measured on the First Day of Cycle 1 and on the First Day of Cycle 3||Within 4 months of taking single agent and 6 months of taking the combination||||||
68657|NCT01121757|Secondary|Number of Participants With Grade 3 and 4 Toxicities|Evaluate the safety of lenalidomide, azacitidine and the combination of azacitidine + lenalidomide in patients with lymphoma; grading the adverse events using Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0|While taking the study drug and 30 days after the last dose|||participants|||Number
68658|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 6 months on combination drug.|Only subjects that completed combination drug will be included in analysis.|||||
68659|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on second drug.|Everyone who started the second drug regimen||participants|||Number
68660|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on first study drug.|Everyone who started the first drug regimen||participants|||Number
68661|NCT01121757|Primary|Response Predicted by Molecular Signatures Compared to True Response|"The predicted response (response to therapy vs. no response to therapy) using gene sequencing will be compared to the overall true response (reported in Primary Outcome 2)."|approximately one year|The number of participants who were evaluated for a response were analyzed to see if the prediction of response vs. no response through gene expression matched the true response.||participants|||Number
68662|NCT01121666|Secondary|Quality of Oocytes Retrieved|The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population||Percentage of cells|||Number
68663|NCT01121666|Secondary|Quality of Oocytes Retrieved|The maturity of the cumulus oophorus was assessed.|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population||Percentage of cumulus oophori|||Number
68664|NCT01121666|Secondary|Ongoing Pregnancy (Second Treatment Cycle)|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|10 weeks after embryo transfer|Population with a second treatment cycle||Ongoing pregnancies|||Number
68665|NCT01121666|Secondary|Clinical Pregnancy Rate (Second Treatment Cycle)|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Population with a second treatment cycle||Clinical pregnancies|||Number
68666|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of embryos per blastocysts transferred|Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval|Intention to treat population||embryos per blastocysts transferred||Standard Deviation|Mean
68667|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with transferred blastocysts|At day 4 and 5|Intention to treat population||Participants|||Number
68668|NCT01121666|Secondary|Embryo Quality: Absence of Multinucleation|"Main embryo quality parameter absence of multinucleation observed."|Day 3|Intention to treat population||Percentage of absent multinucleation|||Number
68669|NCT01121666|Primary|Number of Oocytes Retrieved (Intention-to-treat Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.~The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Intention-to-treat population||Number of retrieved oocytes||Standard Deviation|Mean
68670|NCT01121666|Secondary|Live Birth Rate|Patients with liveborn children|After childbirth with questionnaire|Intention to treat population||Patients with liveborn children|||Number
68671|NCT01121666|Secondary|Ongoing Pregnancy|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|Ten weeks after embryo transfer|Intention to treat population||Ongoing pregnancies|||Number
68672|NCT01121666|Secondary|Clinical Pregnancy Rate|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Intention to treat population||Clinical pregnancies|||Number
68682|NCT01121666|Secondary|E2 Concentration at Day 8 and at Day of hCG Administration|The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.|Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)|All participants were analyzed.||pmol/ L||Standard Deviation|Mean
68683|NCT01121666|Secondary|Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation|The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.|Day 8 of stimulation|All participants were analyzed.||Number of follicles||Standard Deviation|Mean
68684|NCT01121666|Primary|Number of Oocytes Retrieved (Per Protocol Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.~The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Per protocol population||Number of retrieved oocytes||Standard Deviation|Mean
68685|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tmax was observed directly from data as time of first occurrence.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68686|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tlast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tlast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tlast was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68687|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmax was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68688|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmin|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmin) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmin was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68689|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUC24|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUC24) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUC24 was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68690|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUClast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUClast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68716|NCT01121575|Secondary|Progression Free Survival (PFS) in Escalation Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||Months||95% Confidence Interval|Median
68691|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tmax. Tmax was observed directly from data as time of first occurrence.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68692|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tlast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tlast. Tlast was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68693|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmax. Cmax was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68694|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmin|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmin. Cmin was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68695|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUC10|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUC10. AUC10 was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68696|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUClast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUClast. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68717|NCT01121575|Secondary|Duration of Response for the Only Participant Shown Partial Response in Expansion Phase|This outcome measure presented the duration of response for one participant in expansion cohort 1 who showed partial response.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|This Outcome Measure was only assessed for participants with response.||Weeks|||Number
68697|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for dacomitinib and PF-05199265. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68698|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tlast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for dacomitinib and PF-05199265. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68699|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Cmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for dacomitinib and PF-05199265. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68700|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUC24|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUC24 for dacomitinib and PF-05199265. AUC24 was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68701|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUClast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for dacomitinib and PF-05199265. AUClast was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68702|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase -Time to Maximum Plasma Concentration (Tmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for crizotinib and PF-06260182. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68703|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Time of Last Quantifiable Concentration (Tlast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for crizotinib and PF-06260182. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||Hour||Full Range|Median
68704|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Maximum Plasma Concentration (Cmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for crizotinib and PF-06260182. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68733|NCT01121549|Secondary|Time to Disease Progression (TTP)|Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.|Baseline up to Year 3|Time to disease progression was considered complementary to RFS and hence, was not analyzed.|||||
68734|NCT01121549|Secondary|Recurrence-free Survival (RFS)|Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.|Baseline up to Year 3|A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.||weeks||Full Range|Median
68705|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Curve 10 (AUC10)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). AUC10 was calculated using Linear/Log trapezoidal method. The below analysis table included geometric Mean and Geometric Coefficient of Variation of AUC10 for crizotinib and PF-06260182. Arithmetic mean was presented if the n=2.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68706|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Concentration (AUClast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for crizotinib and PF-06260182. AUClast was calculated using Linear/Log trapezoidal method.|Cycle 1 (C1)/Day 1 (D1), C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
68707|NCT01121575|Secondary|Number of Participants With ROS1 Gene Translocation at Baseline|Sample analyses were performed in accordance to GLP guidance and included translocation detection (RNA based) for ROS1 gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. However, number of participants analyzed in the below table included the participants evaluated for ROS1 gene translocation.||Participants|||Number
68708|NCT01121575|Secondary|Number of Participants With PIK3CA Mutation at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for PIK3CA gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
68709|NCT01121575|Secondary|Number of Participants With KRAS Mutation (GLY12CYS) at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for KRAS gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
68710|NCT01121575|Secondary|Number of Participants With EGFR Mutation at Baseline|Sample analyses were performed in accordance to Good Laboratory Practice (GLP) guidance and included mutation detection for EGFR gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
68711|NCT01121575|Secondary|Plasma Concentration of sMet by Study Visits|This outcome measure presented the plasma concentration of sMet at different study visits. s-Met was analyzed using an enzyme-linked immunosorbent assay (ELISA).|At screening and Cycle 1 Day 1 (C1D1) (6 hours post dose), and C1D15, C2D1, C2D15 (all predose).|The soluble protein analysis population included participants in safety analysis who had a screening or C1D1 soluble protein assessment, and at least one on-treatment soluble protein assessment (C1D14 C2D1 or C2D14).||pg/mL||Standard Deviation|Mean
68712|NCT01121575|Secondary|Number of Participants With c-Met, HER2, EGFR Amplification and ALK Rearrangement at Baseline Using FISH Method|Participants showed amplification of c-Met, HER2, and EGFR in the tumor cells and gene rearrangement of ALK are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Participants|||Number
68713|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (EGFR, and c-Met) at Baseline Using Fluorescent in Situ Hybridization (FISH) Method|Expression of tumor biomarkers EGFR and cMet at Baseline (using FISH method) are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||Ratio||Full Range|Median
68714|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (HGF, EGFR, and c-Met ) at Baseline Using Immunohistochemistry (IHC) Method|Tumor biomarkers such as HGF, EGFR, and c-Met were analyzed in tumor cells (neoplastic compartment) of tumor specimens from both expansion cohorts 1 and 2 by IHC. The H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+, where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum calculated score of 0 to maximum calculated score of 300, where 0 correspond to no expression and maximum score of 300 indicates the strongest expression. However, the biomarker expression level (higher or lower) was not a predictor of outcome.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.||H-Score||Full Range|Median
68715|NCT01121575|Secondary|Progression Free Survival (PFS) in Expansion Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. In Expansion Cohort 1, two participants had censored reasons of “no adequate baseline”, of which one participant had a censored reason “no tumor assessment data available.||Months||95% Confidence Interval|Median
68735|NCT01121549|Secondary|Percentage of Participants Who Discontinued the Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||percentage of participants|||Number
68718|NCT01121575|Secondary|Number of Participants With ORR in Expansion Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants||95% Confidence Interval|Number
68719|NCT01121575|Secondary|Number of Participants With Objective Response Rate (ORR) in Escalation Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants||95% Confidence Interval|Number
68720|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to RECIST (1.1) as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants|||Number
68721|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) - 1.1 as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.||Participants|||Number
68722|NCT01121575|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase|DLTs were those AEs which occurred in Cycle 1 of treatment in Dose Escalation Phase which may be attributed to study drug [combined Crizotinib (PF-02341066) plus Dacomitinib (PF-00299804)] without a clear alternative explanation and despite the use of adequate/maximal medical intervention as dictated by local institutional clinical practices or the judgment of the investigator. The following events were considered DLTs (using CTCAE version 4.02);1. Grade ≥4 hematologic events. 2. Grade ≥3 non-hematological events (except Grade 3/4 asymptomatic hypophosphatemia and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea had to have persisted at Grade 3 or 4 despite maximal medical therapy. Grade 3 hypertension will be considered a DLT only if the event is unmanageable by standard approved pharmacologic agents or if the symptomatic sequelae are identified despite appropriate medical intervention.|Cycle 1 (4 weeks)|The DLT evaluable population was defined as safety analysis (SA) participants in the Dose Escalation phase who did not have a major treatment deviation during the first cycle.||Participants|||Number
68723|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||Participants|||Number
68736|NCT01121549|Secondary|Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy||Baseline up to Year 3|FAS included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
68737|NCT01121549|Secondary|Number of Participants With Reasons for Discontinuing Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
68944|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8|Week 8|||participants|||Number
68724|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||participants|||Number
68725|NCT01121575|Primary|Overview of Treatment-emergent All Causalities AEs in Expansion Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||Participants|||Number
68726|NCT01121575|Primary|Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. Serious adverse event (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.||participants|||Number
68727|NCT01121562|Secondary|Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).|"Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, observed concentration multiplied by 37.5 over actual dose.~SU012662 is an active metabolite of sunitinib."|Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1|"The pharmacokinetics analysis set was defined as all participants who had at least one plasma concentration data at trough sampling with steady-state condition. n in the measured values means number of participants analyzed."||nanogram/mL||Standard Deviation|Mean
68728|NCT01121562|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.|Up to 3 years from the last subject registration to the study|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.~OS was not analyzed due to short of events."||Months||95% Confidence Interval|Median
68729|NCT01121562|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.~Median PFS had not yet been reached due to short of events."||Months||95% Confidence Interval|Median
68730|NCT01121562|Secondary|Tumor Shrinkage|Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication. n  in the measured values means number of participants analyzed in the cycle."||percent change||Standard Deviation|Mean
68731|NCT01121562|Secondary|Objective Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
68732|NCT01121562|Primary|Clinical Benefit Response Rate (CBR)|"CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks.~Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started."|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.||percentage of participants||95% Confidence Interval|Number
68738|NCT01121549|Secondary|Number of Missed Exemestane Doses||Week 25, 49, 73, 97, 121, 145|Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported.||missed doses||Standard Deviation|Mean
68739|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug|An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
68740|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.||participants|||Number
68741|NCT01121536|Primary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|"HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of participants with both a baseline and post-baseline assessment.||units on a scale||Standard Deviation|Mean
68742|NCT01121536|Primary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. Baseline was the assessment before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both a baseline and post-baseline assessment.||units on a scale||Standard Deviation|Mean
68743|NCT01121536|Secondary|Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or the last post-baseline assessment)|Full analysis set of participants with both a baseline and post-baseline assessment.||units on a scale||Standard Deviation|Mean
68744|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression|"The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set||units on a scale||Standard Deviation|Mean
68745|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|"The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set||units on a scale||Standard Deviation|Mean
68945|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4|Week 4|||participants|||Number
68746|NCT01121536|Primary|Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV)|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated.~- C-SSRS=Columbia Suicide Severity Rating Scale"|Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit|Safety population; only 19 participants were asked the last three questions as the inclusion of these questions depends on physician assessment.||participants|||Number
68747|NCT01121536|Primary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|"The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline (double-blind study) and treatment assessments during the open-label study.||units on a scale||Standard Deviation|Mean
68748|NCT01121536|Primary|Change From Baseline to Endpoint in Body Weight|Baseline was the score before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both baseline and post-baseline assessments.||kg||Standard Deviation|Mean
68749|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set||units on a scale||Standard Deviation|Mean
68750|NCT01121536|Primary|Physical Examination Shifts From Baseline to Endpoint|"Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint.~HEENT = Head, Eye, Ear, Nose and Throat exam"|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with baseline and endpoint assessments Participants n=: General appearance 785, HEENT 784, Chest and lungs 785, Heart 785, Abdomen 785, Musculoskeletal 785, Skin 785, Lymph nodes 780, Neurological 784||participants|||Number
68751|NCT01121536|Primary|Change From Baseline to Endpoint in Electrocardiogram (ECG) Values|"ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination).~RR= inter-beat intervals"|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of treated participants with both baseline and post-baseline ECG assessments||msec||Standard Deviation|Mean
68752|NCT01121536|Primary|Participants With Clinically Significant Abnormal Vital Signs Values|"Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria:~Pulse high: >=120 beats per minute (bpm) and increase of >=15 bpm from baseline~Pulse low: <=50 bpm and decrease of >=15 bpm from baseline~Sitting systolic blood pressure high: >=180 mm Hg and increase of >=20 mm Hg from baseline~Sitting systolic blood pressure low: <=90 mm Hg and decrease of >=20 mm Hg from baseline~Sitting diastolic blood pressure high: >=105 mm Hg and increase of >=15 mm Hg from baseline~Sitting diastolic blood pressure low: <=50 mm Hg and decrease of >=15 mm Hg from baseline"|Day 1 to Month 6|Safety population with post-baseline vital signs assessments||participants|||Number
68753|NCT01121536|Primary|Participants With Clinically Significant Abnormal Urinalysis Values|Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was >=2 unit increase from baseline.|Day 1 to Month 6|Safety population with post-baseline urinalysis assessments||participants|||Number
68754|NCT01121536|Primary|Participants With Clinically Significant Abnormal Hematology Values|"Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~WBC - white blood cell counts with a normal range of 3.8-10.7 10^9/L.~Hemoglobin with a normal range of 115-181 g/L~Hematocrit with a normal range of 0.34-0.54 L/L~Platelet counts with a normal range of 130-400 10^9/L~ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10^9/L"|Day 1 to Month 6|Safety population with post-baseline hematology assessments||participants|||Number
68755|NCT01121536|Primary|Participants With Clinically Significant Abnormal Serum Chemistry Values|"Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women.~GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L~ALT = alanine aminotransferase with a normal range of 6-43 U/L~BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L~AST = aspartate aminotransferase with a normal range of 9-36 U/L"|Day 1 to Month 6|Safety population with post-baseline serum chemistry assessments||participants|||Number
69149|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
68756|NCT01121536|Primary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 up to Month 6|Safety population||participants|||Number
68757|NCT01121484|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8|10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF||cm||Standard Deviation|Mean
68758|NCT01121484|Secondary|Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)|This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF||Units on a scale||Standard Deviation|Mean
68759|NCT01121484|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.|Baseline, Week 8|FAS||Units on a scale||Standard Deviation|Mean
68760|NCT01121484|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF||Units on a scale||Standard Deviation|Mean
68761|NCT01121484|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS; LOCF||participants|||Number
68762|NCT01121484|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8|HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.|Baseline, Week 8|Full Analysis Set (FAS) Population: randomized participants who had a baseline HAM-D17 score, took at least 1 dose of investigational product, and had at least 1 postbaseline HAM-D17 evaluation. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
68763|NCT01121406|Secondary|Biomarkers and Pharmacogenetics Analysis (Optional)|This endpoint has not been statistically analysed in the study report|6 months||||||
68764|NCT01121406|Secondary|Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS|Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Litres||Geometric Coefficient of Variation|Geometric Mean
68765|NCT01121406|Secondary|CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration|CL; total clearance of BI 6727 BS in plasma after intravenous administration|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||mL/min||Geometric Coefficient of Variation|Geometric Mean
68766|NCT01121406|Secondary|MRT; Mean Residence Time of BI 6727 BS in the Body|MRT; Mean residence time of BI 6727 BS in the body|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Geometric Coefficient of Variation|Geometric Mean
68767|NCT01121406|Secondary|t1/2; Terminal Half-life of CD 10899 BS in Plasma|t1/2; Terminal half-life of CD 10899 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Geometric Coefficient of Variation|Geometric Mean
68768|NCT01121406|Secondary|t1/2; Terminal Half-life of BI 6727 BS in Plasma|t1/2; Terminal half-life of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Geometric Coefficient of Variation|Geometric Mean
68769|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma|tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
68917|NCT01120275|Secondary|Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response|Complete disappearance of all measurable and non-measurable disease, or greater than or equal to 30% decrease under baseline of the sum of the longest diameters of all target measurable lesions.|Disease assessments for response were performed every 6 weeks, up to 3 years|||portation of participants||95% Confidence Interval|Number
68770|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma|tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
68771|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma|Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68772|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma|Cmax; maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68773|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
68774|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
68775|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
68776|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
68777|NCT01121406|Secondary|Clinically Relevant Changes in Laboratory and ECG Data|Clinically relevant changes in laboratory and ECG data|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS||percentage of participants|||Number
68778|NCT01121406|Secondary|Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS||participants|||Number
68779|NCT01121406|Secondary|Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)|"Three most troublesome disease specific symptoms, defined by the patient at baseline.~Patients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.~Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks)|TS||weeks||Inter-Quartile Range|Median
68780|NCT01121406|Secondary|Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)|"Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
68781|NCT01121406|Secondary|Time to Deterioration in Pain/ Quality of Life (QOL)|"Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
92743|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).||Baseline up to Month 7|||percentage of participants|||Number
68782|NCT01121406|Secondary|Time to Deterioration in Fatigue/Quality of Life (QOL)|"Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
68783|NCT01121406|Secondary|Time to Deterioration in Global Health Status/Quality of Life (QOL)|"Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
68784|NCT01121406|Secondary|Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.~Also according to the below criterias,~In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.~Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or~Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or~Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart."|At screening and every 6 weeks thereafter (Up to 213 weeks )|TS||weeks||Inter-Quartile Range|Median
68785|NCT01121406|Secondary|Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.~Biological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter."|At screening and every 6 weeks thereafter (Up to 213 weeks)|TS||participants|||Number
68786|NCT01121406|Secondary|Best Overall Response|"Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.~Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed."|time from the date of randomisation until study completion/discontinuation; Up to 213 weeks|TS||participants|||Number
68787|NCT01121406|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death irrespective of the cause of the death.|From randomization until death or study discontinuation; Up to 213 weeks|TS||weeks||Inter-Quartile Range|Median
68788|NCT01121406|Secondary|Progression Free Survival (PFS)|"Progression-free survival of a patient was based on the investigator’s assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.~Definition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.~Non-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions"|From randomization until disease progression, death or study discontinuation; Up to 213 weeks|TS||weeks||Inter-Quartile Range|Median
68789|NCT01121406|Primary|Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).|Week 24|TS||percentage of participants||95% Confidence Interval|Number
68790|NCT01121393|Secondary|Changes in Safety Laboratory Parameters|"Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase.~For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented.~Only data collected up to the analysis cut-off date (27 December 2013) were considered."|From first administration of study medication up to 28 days after the last administration of study medication up to 42.2 months|Treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated according to the treatment actually received. Patients with a baseline and at least one on-treatment assessment of the parameter of interest (Number of patients (N) are specified in the category title).||percentage of participants|||Number
68810|NCT01121185|Post-Hoc|Time To Viral Rebound Post-Transplantation(Serum HCV RNA Increased ≥ 1 log10 From Viral Nadir)|The time of viral rebound was defined as the time of the first measurement of serum HCV RNA increased ≥ 1 log10 from the viral nadir (the lowest serum HCV RNA level post-transplantation). Serum HCV RNA was measured by RT-PCR.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||days||Full Range|Mean
68811|NCT01121185|Secondary|Time to Onset of Recurrence of Detectable HCV RNA Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||days|||Number
68791|NCT01121393|Secondary|Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events|"Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.~Only data collected up to the analysis cut-off date (27 December 2013) were considered."|From first administration of study medication up to 28 days after the last administration of study medication up to 42.2 months|The treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.||percentage of participants|||Number
68792|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 43|Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 43 (course 3, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68793|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 29|Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 29 (course 2, visit 2)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
68794|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 22|Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 22 (course 2, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
68795|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Pain|"HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.||months||95% Confidence Interval|Median
68796|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea|"HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.||months||95% Confidence Interval|Median
68797|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing|"HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.||months||95% Confidence Interval|Median
68798|NCT01121393|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|"The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.~Only data collected up to the analysis cut-off date (27 December 2013) were considered.~ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;~Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work;~Ambulatory (>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities;~Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;~Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;~Dead"|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status.||percentage of participants|||Number
68799|NCT01121393|Secondary|Change From Baseline in Body Weight|The change from baseline to the lowest and the last body weight recorded or during the the study. Only data collected up until the analysis cut-off date (27 December 2013) were considered.|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight.||kilogram (kg)||Standard Deviation|Mean
68918|NCT01120275|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years.|||Months||95% Confidence Interval|Median
68800|NCT01121393|Secondary|Tumour Shrinkage|"Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.~The means are adjusted for baseline sum of lesions and EGFR mutation category."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set. There were ony 220 patients in the Afatinib arm and 101 patients in the Gemcitabine / Cisplatin arm with baseline and post-baseline target lesion measurements.||millimetre (mm)||Standard Error|Mean
68801|NCT01121393|Secondary|Duration of Disease Control|"For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set with disease control.||months||95% Confidence Interval|Median
68802|NCT01121393|Secondary|Duration of Objective Response|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The Randomised set with an objective response.||months||95% Confidence Interval|Median
68803|NCT01121393|Secondary|Time to Objective Response (OR)|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.~Outcome data are the percentage of patients with OR by each scheduled tumour assessment.~Only data collected up until the analysis cut-off date (27 December 2013) were considered."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The RS included all patients randomised to receive treatment, whether treated or not.||percentage of participants|||Number
68804|NCT01121393|Secondary|Overall Survival (OS)|"OS is defined as the time from randomisation to death. For patients who had not died by the cut-off date (27 Dec 2013), the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.~Median time results from unstratified Kaplan-Meier estimates."|From randomisation up to 27 Dec. 2013 cut off date for this analysis|The randomised set.||months||95% Confidence Interval|Median
68805|NCT01121393|Secondary|Disease Control (DC)|"DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.~Only data collected up until the analysis cut-off date (27 December 2013) were considered."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set.||percentage of participants||95% Confidence Interval|Number
68806|NCT01121393|Secondary|Objective Response (OR)|"OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.~CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.~PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.~Only data collected up until the analysis cut-off date (27 December 2013) were considered.~(Exact 95% Confidence interval by Clopper and Pearson.)"|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set.||percentage of participants||95% Confidence Interval|Number
68807|NCT01121393|Primary|Progression-free Survival|"The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.~Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.||months||95% Confidence Interval|Median
68808|NCT01121263|Secondary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:~Death~Stroke~Myocardial infarction~Repeat revascularization"|Occurence of MACCE through the end of study up to two years|||participants|||Number
68809|NCT01121263|Primary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:~Death~Stroke~Myocardial Infarction~Repeat Revascularization"|Month 12|||participants|||Number
68879|NCT01120405|Secondary|Number of Participants With Cerebro-Vascular Event|Patients with Cerebro-Vascular Event in the FAS|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
68812|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Total Bilirubin|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the total bilirubin at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||mg/dL||Full Range|Mean
68813|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Alanine Aminotransferase (ALT)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the ALT at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||U/L||Full Range|Mean
68814|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / International Normalized Ratio (INR)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the INR at each time-point. The INR is the ratio of a patient's prothrombin time to a control sample, raised to the power of the ISI value (International Sensitivity Index) for the batch of tissue factor being used for the assay.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||unitless||Full Range|Mean
68815|NCT01121185|Secondary|Histologic Evidence of Hepatitis by Histologic Activity Index (HAI) Score at Baseline and Day 42|Liver biopsies obtained at baseline (day 0) and day 42 post-transplantation were assessed for histologic evidence of hepatitis by a pathologist blinded to treatment assignment using the Ishak modification of the Knodell histologic grading system to assign a histologic activity index (HAI) score. The HAI score consists of a sum of four components: 1) periportal or periseptal interface hepatitis; 2) confluent necrosis; 3) focal lytic necrosis, apoptosis and focal inflammation; 4) portal inflammation. The total HAI score can range from a minimum of 0 to a maximum of 18, with higher scores indicating more severe hepatic inflammation.|Baseline Day 0 and Day 42|The 11 subjects who were randomized, initiated study infusions, and underwent transplantation were included in the analysis population. On day 0, all subjects had pre-transplant biopsy specimens available for analysis. On day 42, 4 subjects in the MBL-HCV1 group and 5 subjects in the placebo group had biopsy specimens available for analysis.||Histologic activity index (HAI) score||Full Range|Median
68816|NCT01121185|Secondary|Change in Serum HCV RNA Between Baseline and Day 3, 14, 28 and 42 Post-Transplantation|Serum HCV RNA was measured by quantitative RT-PCR. The change in HCV RNA from baseline was obtained by calculating the difference between the baseline pre-transplantation HCV RNA level and the HCV RNA level measured at each study visit.|Baseline and Day 3, 14, 28 and 42 Post-Transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||log10 IU/mL||Full Range|Median
68817|NCT01121185|Secondary|The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined Through Medical History, Physical Examination and Laboratory Evaluation|Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Subjects were asked at scheduled study visits through day 42 whether they experienced solicited adverse reactions (fever, chills, nausea, rash, joint pain or swelling, shortness of breath, headache, fatigue, and hives). In addition to these solicited adverse events, subjects were asked at all scheduled study visits through day 56 to report any other adverse events, regardless of whether the event was thought to be related to the study infusions. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 12.0)|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||events|||Number
68818|NCT01121185|Primary|Proportion of Subjects With Detectable Serum HCV RNA at Day 42 Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|At Day 42 post-transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.||percentage of participants|||Number
68819|NCT01121172|Secondary|Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents|Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group|First day after enrollment|Data were collected only from the Obese participants. Data regarding the genetic polymorphism were not collected from participants forming the Lean Arm/Group.||participants|||Number
68820|NCT01121172|Primary|Serum Apelin Levels|Apelin levels were measured in serum of participants, in fasting state|First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning|||ng/ml||Full Range|Median
68821|NCT01121146|Secondary|Patient Satisfaction|"Patient satisfaction was quantified by asking participants to respond yes or no to the question, Are you satisfied with the results of your hip operation?"|Minimum 9-year follow-up|Satisfaction rates were evaluated among 84 participants with unrevised hips who had Marathon and 70 participants with unrevised hips who had Enduron polyethylene. These participants had minimum 9-year follow-up and responded to the question about satisfaction.||percentage of participants|||Number
68822|NCT01121146|Secondary|Harris Hip Score|The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best).|Minimum 9-year follow-up|Harris Hip Scores were evaluated for 74 unrevised hips with Marathon and 65 unrevised hips with Enduron polyethylene that had minimum 9-year follow-up and complete data to compute a score.||score on a 100 point scale||Standard Deviation|Mean
68823|NCT01121146|Secondary|Rate of Reoperation|The rate of reoperation was based on the number of reoperations in each group. Any additional surgery after a participant’s initial hip replacement was considered a reoperation.|10-year follow-up|All 116 hips randomized to Marathon polyethylene and all 114 hips randomized to Enduron polyethylene were included in the analysis population to determine the rate of reoperation.||THAs|||Number
68824|NCT01121146|Secondary|Polyethylene Wear|A single reviewer, who was blinded to the type of polyethylene liner, evaluated femoral head penetration among all unrevised hips with minimum 9-year radiographic follow-up using serial anteroposterior pelvic radiographs. Two-dimensional head penetration was determined for each follow-up radiograph relative to the immediate post-operative (nominal 6-week follow-up) reference view using Hip Suite Analysis version 8.0 with elliptical correction, a validated, computer-assisted technique. A linear wear rate was evaluated for each hip that had a minimum of three follow-up radiographs by using a least-squares linear regression to calculate the slope of the best-fit line for the wear vector magnitude versus time in situ data. The slope from this regression represented the steady-state linear wear rate. The steady-state linear wear rate data from all hips in a group was used to compute a mean polyethylene wear value.|Minimum 9-year radiographic follow-up|At least 3 head penetration measurements evaluated with Martell’s Hip Suite Analysis software were available for 76 unrevised hips with Marathon and 66 unrevised hips with Enduron polyethylene.||millimeters per year||Standard Deviation|Mean
68825|NCT01121146|Primary|Incidence of Clinically Significant Osteolysis|The incidence of clinically significant osteolysis was based on the number of unrevised THAs (total hip arthroplasties) with at least 1.5 square centimeters of pelvic and/or femoral osteolysis. Osteolysis was defined as an area of localized loss of trabecular bone or cortical erosion that was not apparent on the pre-operative or immediate postoperative radiograph. To obtain lesion sizes, the defects were outlined on the anteroposterior pelvic radiograph and the area of the lesion was measured using Martell's Hip Analysis Suite software. Lesions were considered clinically important if the total area of osteolysis around a hip replacement was at least 1.5 square centimeters.|Minimum 9-year radiographic follow-up|Minimum 9-year radiographs used to assess osteolysis were available for 79 unrevised hips with Marathon and 68 unrevised hips with Enduron polyethylene.||unrevised THAs|||Number
68826|NCT01120990|Primary|Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
68827|NCT01120990|Primary|Diastolic Blood Pressure Measured by Tested Device.|Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
68828|NCT01120990|Primary|Systolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
68829|NCT01120990|Primary|Systolic Blood Pressure Measured by Tested Device.|Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.||mmHg||Standard Deviation|Mean
68830|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months|||Eyes|Participants||Number
68831|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months|||Eyes|Participants||Number
68832|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months|||Eyes|Participants||Number
68880|NCT01120405|Secondary|Number of Participants With Myocardial Infarction (MI)|Patients with Confirmed Myocardial Infarction (MI) by the Investigators|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
68833|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months|||Eyes|Participants||Number
68834|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months|||Eyes|Participants||Number
68835|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months|||Eyes|Participants||Number
68836|NCT01120899|Primary|Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 months|||Eyes|Participants||Number
68837|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months|||Eyes|Participants||Number
68838|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months|||Eyes|Participants||Number
68839|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 24 Months|||percentage change in retinal thickness|Participants|Standard Deviation|Mean
68840|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 18 Months|||percentage change in retinal thickness|Participants|Standard Deviation|Mean
68841|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 12 Months|||percentage change in retinal thickness|Participants|Standard Deviation|Mean
68842|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months|||percentage change|Participants|Standard Deviation|Mean
68843|NCT01120899|Secondary|Change in BCVA in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months|||ETDRS letters|Participants|Standard Deviation|Mean
68844|NCT01120899|Secondary|Change in BCVA in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months|||ETDRS letters|Participants|Standard Deviation|Mean
68845|NCT01120899|Secondary|Change in BCVA in the Study Eye at 12 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 12 Months|||ETDRS Letters|Participants|Standard Deviation|Mean
68846|NCT01120899|Secondary|Change in BCVA in the Study Eye at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months|||ETDRS Letters|Participants|Standard Deviation|Mean
68847|NCT01120782|Primary|Prescription Equivalence|Number of subjects whose prescription is the same for the two lenses tested.|after 15 minutes of lens wear|All completed subjects.||participants|||Number
68848|NCT01120717|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
68849|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
68850|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
68851|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.||participants|||Number
68852|NCT01120717|Secondary|Pre-dose FEV1|Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.|52 weeks|Full analysis set - all randomized patients who received at least one dose of study drug. Only patients with the required data were included in this analysis.||Liter||Standard Error|Least Squares Mean
68919|NCT01120275|Primary|Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.|Disease assessments were performed every 6 weeks, up to 3 years.|||Months||95% Confidence Interval|Median
68853|NCT01120717|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks + Follow-up (Up to Day 394)|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis.||participants|||Number
68854|NCT01120704|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.~Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence."|Assessed at 52 weeks after target quit day|||participants|||Number
68855|NCT01120704|Secondary|Latency to Relapse|Latency to Relapse during the first 12 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored|Assessed during the first 12 months post-quit after target quit day|||participants|||Number
68856|NCT01120691|Secondary|St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, Forced Expiratory Volume in 1 Second (FEV1) prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates. SGRQ total score is the sum of the scores from the three components; symptoms, activity and impacts.|12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.||units on a scale||Standard Error|Least Squares Mean
68857|NCT01120691|Secondary|Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set(mFAS)included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis||percentage of days||Standard Error|Least Squares Mean
68858|NCT01120691|Secondary|Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period|The severe or less FEV1 % predicted (post bronchodilator)>=30%; very severe=> FEV1 % predicted(the post bronchodilator)<30%.Number of puffs of rescue medication taken in the previous 12 hours was recorded in patient diary in the morning and in the evening for 26 weeks.The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient.Rescue medication data recorded during the 14 day run-in was used to calculate the baseline.A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set mFAS included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis||# puffs||Standard Error|Least Squares Mean
68859|NCT01120691|Secondary|Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.~Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis"|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.||L (liters)||Standard Error|Least Squares Mean
68881|NCT01120405|Secondary|Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)|At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)|3 Postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
68860|NCT01120691|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.~Spirometry measurements taken were FEV1 at -45 minutes and -15 minutes pre-dose. Three acceptable maneuvers had to be performed for each time point. The FEV1 values recorded had to be the highest values measured irrespective of whether or not they occurred on the same curve.~The mixed model for analysis contained treatment as a fixed effect with average of the 45 minutes and 15 minutes pre dose FEV1 measurements at day 1 as the baseline measurement, FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at -14 Day) as covariates."|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.||L (liters)||Standard Error|Least Squares Mean
68861|NCT01120691|Secondary|Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points|Cumulative rates were estimated using Anderson and Gill method. Chronic Obstructive Pulmonary Disease (COPD) exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26, 52, 64, 76 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis.||exacerbations per year|Participants|95% Confidence Interval|Number
68862|NCT01120691|Secondary|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized||percentage of participants|||Number
68863|NCT01120691|Secondary|Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.|Time to Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized. Analysis population included patients with study withdrawal or premature discontinuation for any reason.||days||95% Confidence Interval|Median
68864|NCT01120691|Secondary|Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics|The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site with GCP non-compliance. This is a sub-group analysis with mutually exclusive population in each category for analysis.||Days||Standard Deviation|Mean
68865|NCT01120691|Secondary|Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.||exacerbations per year|Participants||Number
68866|NCT01120691|Secondary|Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. Only patients with a moderate or severe COPD exacerbation were included in this analysis.||days||95% Confidence Interval|Median
68882|NCT01120405|Primary|Number of Participants With Myocardial Necrosis (MN)|Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)|3 Postoperative Days|Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
68920|NCT01120236|Other Pre-specified|Change in microRNA Measures|Pearson and Spearman correlations will be initially evaluated between microRNA measures and CTC counts. Analysis of covariance will be used to assess the relationship between microRNA and CTC, after adjusting for stratification factors.|Baseline to 12 weeks||||||
68867|NCT01120691|Secondary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|76 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance.||Exacerbations per year|Participants||Number
68868|NCT01120691|Primary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site , which had major issues with Good Clinical Practice (GCP) compliance.||Exacerbations per year|Participants||Number
68869|NCT01120626|Secondary|Aberrant Behavior Checklist (ABC)|The Aberrant Behavior Checklist is a 58-item symptom checklist for assessing problem behaviors. The ABC was rated by each participant's parent. Each item is rated on a four-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). The ABC Total score (range 0-174) is the sum of all individual item scores. Higher score indicates more maladaptive behaviors/worse outcome.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 39 of 42 participants were administered the ABC at week 12.||units on a scale||Standard Deviation|Mean
68870|NCT01120626|Primary|Contingency Naming Test (CNT) Performance Score|Week 12 Contingency Naming Test (CNT) performance score on Rule 2 (naming shapes) and on Rule 3 (If the inside shape matches the outside shape, name the color, otherwise, name the outside shape). Performance score is the number of correct responses per minute, calculated by dividing the number of correct responses by the time taken to complete the 27 items, and multiplying by 60. Higher scores indicate faster and more accurate responding.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 37 of 42 randomized participants completed CNT Rule 2 at week 12. 34 of 42 randomized participants completed CNT Rule 3 at week 12.||correct responses per minute||Standard Deviation|Mean
68871|NCT01120405|Secondary|Urine Output|Urine volume in milliliter (mL) during the first postoperative hours|From Day 0 until Postoperative Day 1|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||mL||Standard Deviation|Mean
68872|NCT01120405|Secondary|Number of Participants With Chest Pain During the 3 Postoperative Days|Patients with Chest Pain reported at least once per day during the 3 Postoperative Days|From Day 0 until Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||participants|||Number
68873|NCT01120405|Secondary|Vital Signs (Heart Rate Changes)|Changes from baseline for Heart Rate (HR)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||beats per minute||Standard Deviation|Mean
68874|NCT01120405|Secondary|Vital Signs (SBP and DBP Changes)|Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.||mm Hg||Standard Deviation|Mean
68875|NCT01120405|Secondary|Systolic Blood Pressure (SBP)|Repeated Systolic Blood Pressure measurements during the perioperative period|From pre-induction to recovery of anesthesia|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||mm Hg||Standard Deviation|Mean
68876|NCT01120405|Secondary|Number of Participants With Composite Endpoint|Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
68877|NCT01120405|Secondary|Number of Participants Who Died From Cardiac Origin|No patient died from a cardiac cause during the 3 postoperative days.|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
68878|NCT01120405|Secondary|Number of Participants With Life-Threatening Arrhythmia|Patients with Life-Threatening Arrhythmia in the FAS|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.||participants|||Number
68921|NCT01120236|Other Pre-specified|Change in Level of CTCs|Will be correlated with undetectable PSA and normalized PSA response.|Baseline to 12 weeks||||||
68883|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 4-year visit is 1502 days.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants|||Number
68884|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 3-year visit is 1053-1137 days.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants|||Number
68885|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 2-year visit is 688-772 days.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants|||Number
68886|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68887|NCT01120379|Secondary|Major Bleeding Complications (Site Reported)|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68888|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of Clinical Events Committee (CEC)-adjudicated Thrombolysis In Myocardial Infarction (TIMI) major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68889|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68890|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68891|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68892|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68893|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68894|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68895|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68922|NCT01120236|Other Pre-specified|Change in Level of Serum Biomarkers||Baseline to 12 weeks||||||
68896|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68897|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68898|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68899|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68900|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68901|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68902|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68903|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68904|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68905|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68906|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68907|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68940|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment|Change in 24-hour urinary calcium excretion from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)|||mmol/24hr||Standard Deviation|Mean
68908|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68909|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68910|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68911|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68912|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68913|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) as Defined by ARC|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68914|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68915|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.||percentage of participants||95% Confidence Interval|Number
68916|NCT01120275|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
68923|NCT01120236|Secondary|Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)|The logistic regression algorithm for predicting undetectable PSA that was developed for SWOG-9346 using its baseline risk factors (age at registration, performance status, baseline PSA, and bone pain) will be applied to each arm of this trial to evaluate the level of agreement between the observed and predicted undetectable PSA rates.|Up to 5 years||||||
68924|NCT01120236|Secondary|Proportion of Patients Who do Not Achieve a Partial PSA Response|A partial PSA response is considered <= 4 ng/mL|Up to 5 years|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.||participants|||Number
68925|NCT01120236|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 28 weeks|All participants receiving at least some protocol treatment were included in toxicity analysis. Four patients on Arm I (androgen deprivation and cixutumumab) and two patients on Arm II (androgen deprivation therapy) did not receive any protocol treatment and were therefore excluded from this analysis.||Participants|||Number
68926|NCT01120236|Primary|Undetectable PSA Rate|Undetectable PSA rate (<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment|7 months|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.||participants|||Number
68927|NCT01120223|Secondary|Withdrawal|"How many subjects withdrew from the study. Reasons for withdrawal:~due to exclusion criteria emerging, due to AE(s), or due to other reason"|Week 4 and 8|||participants|||Number
68928|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment (up to 8 weeks)|||participants|||Number
68929|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 8|||participants|||Number
68930|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 4|||participants|||Number
68931|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|Week 2|||participants|||Number
68932|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and End of treatment (up to 8 weeks)|||percent of change||Standard Deviation|Mean
68933|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8|||percent change||Standard Deviation|Mean
68934|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.|Baseline and week 4|||percent of change||Standard Deviation|Mean
68935|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 2|||percentage of change||Standard Deviation|Mean
68936|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment|End of treatment (up to 8 weeks)|||participants|||Number
68937|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment|Change in urinary calcium:creatinine ratio from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)|||mmol/g||Standard Deviation|Mean
68938|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8|Change in urinary calcium:creatinine ratio from Baseline to week 8|Baseline and week 8|||mmol/g||Standard Deviation|Mean
68939|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4|Change in urinary calcium:creatinine ratio from Baseline to week 4|Baseline and week 4|||mmol/g||Standard Deviation|Mean
68946|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|Week 2|||participants|||Number
68947|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 8|Change in plasma PTH (parathyroid hormone) from Baseline to week 8|Baseline and week 8|||ng/L||Standard Deviation|Mean
68948|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 4|Change in plasma PTH (parathyroid hormone) from Baseline to week 4|Baseline and week 4|||ng/L||Standard Deviation|Mean
68949|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 8|Change in albumincorrected serum calcium from Baseline to week 8|Baseline and week 8|||mmol/L||Standard Deviation|Mean
68950|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 4|Change in albumincorrected serum calcium from Baseline to week 4|Baseline and week 4|||mmol/L||Standard Deviation|Mean
68951|NCT01120223|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8-weeks|||percent subjects|||Number
68952|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Calculated Systemic Vascular Resistance (SVR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Calculated Systemic Vascular Resistance (SVR) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||dyn.s.cm-5||Standard Error|Least Squares Mean
68953|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Diastolic Pressure (PADP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Square (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
68954|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Systolic Pressure (PASP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Systolic Pressure (PASP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
68955|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Stroke Volume (SV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Stroke Volume (SV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mL/beat||Standard Error|Least Squares Mean
68956|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Fractional Shortening (FS)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Fractional Shortening (FS) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||percentage||Standard Error|Least Squares Mean
68977|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68957|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular Ejection Fraction (LVEF)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular Ejection Fraction (LVEF) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||percentage||Standard Error|Least Squares Mean
68958|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of 30 ng/kg/Min Infusion]) in Left Ventricular End Diastolic Volume (LVEDV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular End Diastolic Volume (LVEDV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mL||Standard Error|Least Squares Mean
68959|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular End Systolic Volume (LVESV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mL||Standard Error|Least Squares Mean
68960|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Diastolic Blood Pressure (DBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of LS mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in Least Square (LS) means (and associated confidence intervals) for change from Baseline in diastolic blood pressure(DBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
68961|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Systolic Blood Pressure (SBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in systolic blood pressure (SBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
68962|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Heart Rate (HR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in heart rate (HR) at each time point as well as treatment group LS means and Standard Errors.|At 1-hour, 2 hours and 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||beats per minute (bpm)||Standard Error|Least Squares Mean
68963|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Capillary Wedge Pressure (PCWP)|The effect of JNJ-39588146 on pulmonary capillary wedge pressure (PCWP) was evaluated by administering multiple ascending doses of JNJ-39588146 or placebo over a 3-hour intravenous (IV) infusion period to patients with heart failure. The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from baseline in PCWP at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||mmHg||Standard Error|Least Squares Mean
92744|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).||Baseline up to Month 7|||percentage of participants|||Number
68964|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Cardiac Index (CI)|The effect of JNJ-39588146 on cardiac index (CI), a hemodynamic parameter that relates heart performance to the size of the individual measured in liters per minute per square metre (l/min/m2) was evaluated in patients with heart failure (HF). The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in CI at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.||L/min/m2||Standard Error|Least Squares Mean
68965|NCT01120197|Secondary|Falls-Efficacy Scale-International|A 16- item self report or interview- based questionnaire assessing the fear of falling during basic and more demanding activities of daily living (Yardley et al. 2005). Each item is scored on a four point scale. Minimun score indicating low concern about falling is 16. The maximun score indication high concern about falling is 64.|Baseline, 3 months follow-up, 12 months follow up||||||
68966|NCT01120197|Secondary|General Health Questionnaire 20 (GHQ20).|GHQ-20 is a generic instrument and registers distress and psychopathology. GHQ-20 is self-administered and the answers to each item may be treated as a “Likert Scale” and have weights assigned to each position (0-1-2-3) where 0 is no distress, and 3 is severe distress. This gives a possible range for the total GHQ-20 score of 0-60. Higher scores indicating poor qol.|At baseline, 3 and 12 months after baseline|||units on a scale||Standard Deviation|Mean
68967|NCT01120197|Secondary|QUALEFFO 41|"Quality of Life Questionnaire issued by the European Foundation for Osteoporosis (QUALEFFO-41), is a disease-specific questionnaire to be used by patients with vertebral fractures attributed to osteoporosis. QUALEFFO-41 is self-administered and contains questions in five domains: pain, ability to perform physical functions, social functioning, general health perception and mental performance. These five domains can be evaluated individually or be represented in a total score. All scores in all the domains are expressed in values ranging from 0-100, where 0 represents the best and 100 the worst. The total QALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100.~High scores indicate poor quality of life."|At baseline, 3 and 12 months after the baseline|||units on a scale||Standard Deviation|Mean
68968|NCT01120197|Secondary|Functional Reach|"The maximum distance in centimetres that can be reached forward in a standing position while maintaining a fixed base of support. Subjects will be instructed to stand sideways against a wall in a natural position and stretch one arm forward level with the shoulder. The position of the third metacarpophalangeal (MCP) joint was taken as the zero point. With the body tilted forward as far as possible, the subjects continued to stretch the arm parallel to the ground.~Amount of cm indicate better balance."|At baseline, 3 and 12 months after the baseline|||Centimetres||Standard Deviation|Mean
68969|NCT01120197|Secondary|Timed Up & Go Test (TUG)|The subject will be instructed to rise from a chair with a seat height of 43 cm, walk 3 m, turn around, return and sit down again, wearing ordinary footwear and use customary walking aids if necessary.|At baseline, 3 and 12 months after the baseline.|||Seconds||Standard Deviation|Mean
68970|NCT01120197|Primary|Time Used to Walk 20 m at Maximal Speed.|Times (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded|At baseline, 3 and 12 months after the baseline|||Seconds||Standard Deviation|Mean
68971|NCT01120093|Secondary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
68972|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
68973|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
68974|NCT01120093|Primary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
68975|NCT01120067|Primary|McGill Pain Questionnaire|McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain.|6 months|||units on a scale||Standard Deviation|Mean
68976|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity on Days 1, 7 and 14|"Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. (see Outcome Measure #23).~Trough FVC was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
69040|NCT01119755|Primary|Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter|Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period|1 year|||mmHg||Standard Deviation|Mean
68978|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68979|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68980|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68981|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68982|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4 hours (postdose) on days 1, 7 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68983|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68984|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Trough FEV1 was measured on Days 1, 7 and 14 of treatment. Trough FEV1 was defined as the mean of the FEV1 values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|23 hours 15 mins and 23 hours 45 mins post-dose on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68985|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity After 28 Days of Treatment|Forced Vital Capacity (FVC) after 28 days of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. Trough FVC was defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose.|23 hours 15 mins and 23 hours 45 mins post-dose on Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68986|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time. Measurements were taken at 25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28."|25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
69041|NCT01119755|Primary|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period|1 year|||mmHg||Standard Deviation|Mean
68987|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Day 28 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68988|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours)|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose). FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68989|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68990|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second by Treatment at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||Standard Deviation|Mean
68991|NCT01119950|Primary|Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19).~All trough FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All trough FEV1 data are reported as a percentage of the theoretical maximal response.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
68992|NCT01119950|Secondary|Mean Daily Use of Rescue Medication by Treatment at Different Time Points|Mean daily use of rescue medication by treatment and time points. Baseline was defined as the average of the total number of puffs of rescue medication during the week prior to treatment start, divided by the total number of days with non-missing rescue data during that week, then puffs were counted during weeks 1, 2, 3 and 4 postdose.|Baseline, Weeks 1, 2, 3 and 4|Only patients with a non-missing value at both period baseline and the respective post-baseline visit were included. The modeling approach is not suitable for these data as the modeling assumptions do not hold.||Number of Puffs||Standard Deviation|Mean
68993|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Vital Capacity on Days 1, 7 and 14|"Percentage of the maximal response of NVA237 Doses on Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was assessed via spirometry. (see Outcome Measure #33).~Trough FVC is defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
68994|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment.~Peak FEV1 was measured in response to all doses administered (see Outcome Measure #32). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
69042|NCT01119755|Secondary|Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
69043|NCT01119755|Primary|Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.|Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period|1 year|||mmHg||Standard Deviation|Mean
69044|NCT01119716|Primary|Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation||up to 60 days from day of treatment (cardioversion)|All enrolled participants with follow-up data available||Participants|||Number
68995|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.~FEV1 was measured in response to all doses administered (see Outcome Measure #31). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
68996|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #30). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
68997|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14 in response to all doses administered (see Outcome Measure #29).~All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
68998|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #28). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
68999|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 hours was calculated from measurements taken at 5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14, in response to all doses administered (see Outcome Measure #27).~All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
69000|NCT01119950|Secondary|Percentage of the Maximal Effect of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours, was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14.~FEV1 AUC 0-24 hours was measured on days 1 and 14 of treatment in response to all doses administered (see Outcome Measure #26). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
69045|NCT01119716|Primary|Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion|Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.|At time of treatment (up to 1 day from admission)|Participants who had artrial fibrillation treated by either electrical or pharmacological cardioversion.||Percentage of Participants|||Number
69001|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on Trough FEV1 was measured on Days 1, 7 and 14.~Through FEV1 was measured in response to all doses administered (see Outcome Measure #25). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
69002|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Vital Capacity at Day 28 of Treatment|"Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Forced Vital Capacity (FVC) was measured at day 28 of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.~FVC at day 28 of treatment was measured via spirometry (see Outcome Measure #24). All FVC responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FVC data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
69003|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Peak FEV1 was measured at day 28 of treatment.~Peak FEV1 was measured in response to all doses administered (see Outcome Measure #23). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
69004|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response within different doses/regimens of NVA237 was measured using FEV1 at 12 hours on day 28 of treatment.~FEV1 was measured in response to all doses administered (see Outcome Measure #22). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response||90% Confidence Interval|Mean
69005|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours) on Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours were calculated from measurements taken at: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #21). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response* hours||90% Confidence Interval|Mean
69006|NCT01119950|Secondary|Forced Expiratory Volume in One Second AUC 0-24 Hours for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237, After 28 Days of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~The Area Under the Curve (AUC) 0-24 hours FEV1 between dosing regimens over the range 20 micrograms to 55 micrograms total daily dose at -25 min,-15 min (predose); 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC 0-24 hours FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 20), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens."|-25 min,-15 min (predose); 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||90% Confidence Interval|Mean
69046|NCT01119716|Primary|Treatments Utilized for Participants for Atrial Fibrillation||At time of Treatment (up to 1 day from admission)|All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation.||Participants|||Number
69047|NCT01119716|Primary|Clinical Type of Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with admission (baseline) atrial fibrillation data available.||Percentage of Participants|||Number
69007|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours at day 28 of treatment was calculated from measurements taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #20). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Percentage of maximal response * hours||90% Confidence Interval|Mean
69008|NCT01119950|Secondary|Trough Forced Expiratory Volume in One Second for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~FEV1 was measured between dosing regimens (over the range 20 micrograms to 55 micrograms total daily dose) after 28 days of treatment.~Mean trough FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 19), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens. The theoretical responses to each dosing schedule separately and the difference between the once-daily and twice-daily regimens are represented below."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.||Liters||90% Confidence Interval|Mean
69009|NCT01119937|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
69010|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
69011|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
69012|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|Safety population - all patients who received at least one dose of study drug. Only participants with the required measurements were included for each specific value.||participants|||Number
69013|NCT01119937|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period|Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug||change in puffs||Standard Deviation|Mean
69014|NCT01119937|Secondary|Change in St. George Respiratory Questionnaire From Baseline|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|Weeks 12, 24, 36, 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.||score on a scale||Standard Deviation|Mean
69015|NCT01119937|Secondary|Number of Patients With Moderate or Severe COPD Exacerbations|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug||participants|||Number
69048|NCT01119716|Primary|Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with co-morbity data available.||Percentage of Participants|||Number
69049|NCT01119716|Primary|Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with baseline cardiovascular history data.||Percentage of Participants|||Number
69016|NCT01119937|Secondary|Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug||days|||Number
69017|NCT01119937|Secondary|Change in Pre-dose FVC From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.||liters||Standard Deviation|Mean
69018|NCT01119937|Secondary|Change in Pre-dose FEV1 From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.||liters||Standard Deviation|Mean
69019|NCT01119937|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug||participants|||Number
69020|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
69021|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
69022|NCT01119859|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
69023|NCT01119859|Secondary|Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24|The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
69024|NCT01119859|Secondary|Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24|The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Percentage of patients|||Number
69065|NCT01119625|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
69025|NCT01119859|Primary|Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.||Units on a scale||95% Confidence Interval|Mean
69026|NCT01119794|Primary|Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment|"Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only.~Complete Response – CR:~• Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~Partial Response - PR:~• At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.~Stable Disease – SD:~• A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease~Relapsed Disease:~• Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis."|Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years|8/10 patients were evaluable as 2 withdrew||participants|||Number
69027|NCT01119768|Secondary|Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|16 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.||percentage of participants|||Number
69028|NCT01119768|Secondary|Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|8 weeks|Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment||percentage of participants|||Number
69029|NCT01119768|Secondary|Percentage of Patients Satisfaction|Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.|24 weeks after end of treatment|MITT||percentage of participants|||Number
69030|NCT01119768|Secondary|Number of Patients With Unscheduled Hospital Visit(s)||from baseline to week 24 after end of treatment|MITT||participants|||Number
69031|NCT01119768|Secondary|Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|2 and 8 weeks|ITT in 8 weeks treatment group||percentage of participants|||Number
69032|NCT01119768|Secondary|Symptom Relief Rate in 2 Treatment Regimens.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|8 weeks for arm 1, 2 weeks for arm 2|ITT was defined as all randomized subjects who took at least one dose of treatment.||percentage of participans|||Number
69033|NCT01119768|Secondary|Time to First Relapse.|"Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.~Time to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint"|From baseline to 24 weeks after end of treatment|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.||days||Inter-Quartile Range|Median
69034|NCT01119768|Secondary|The Success Rate in Whole Study Duration.|Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.|24 weeks after end of treatment|Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment.||percentage of participants|||Number
69035|NCT01119768|Primary|Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|24 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment||percentage of participants|||Number
69036|NCT01119755|Secondary|Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
69037|NCT01119755|Secondary|Mean Difference of Systolic Home Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
69038|NCT01119755|Secondary|Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
69039|NCT01119755|Primary|Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter||1 year|||mmHg||Standard Deviation|Mean
69050|NCT01119703|Secondary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69051|NCT01119703|Secondary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69052|NCT01119703|Secondary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69053|NCT01119703|Secondary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected at 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69054|NCT01119703|Primary|Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln)."|3 weeks or 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69055|NCT01119703|Primary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69091|NCT01119443|Secondary|Cmin,ss (Fed Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
69056|NCT01119703|Primary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69057|NCT01119703|Primary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69058|NCT01119703|Primary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.||ln International Units||Standard Deviation|Mean
69059|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
69060|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
69061|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||EU/mL||95% Confidence Interval|Geometric Mean
69062|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
69063|NCT01119625|Secondary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||EU/mL||95% Confidence Interval|Geometric Mean
69064|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
75765|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||12 months||||||
69066|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||Titers||95% Confidence Interval|Geometric Mean
69067|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||µg/mL||95% Confidence Interval|Geometric Mean
69068|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||EU/mL||95% Confidence Interval|Geometric Mean
69069|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||IU/mL||95% Confidence Interval|Geometric Mean
69070|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||µg/mL||95% Confidence Interval|Geometric Mean
69071|NCT01119625|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||12/2099||||
69072|NCT01119625|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||12/2099||||
69073|NCT01119625|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.||Subjects|||Number
69074|NCT01119625|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 31 days (Days 0-30) after booster vaccination|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.||Subjects|||Number
69075|NCT01119625|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).~Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.~Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.||Subjects|||Number
69076|NCT01119625|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period.~Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.||Subjects|||Number
75766|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||6 months||||||
69077|NCT01119625|Primary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||EU/mL||95% Confidence Interval|Geometric Mean
69078|NCT01119625|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.||µg/mL||95% Confidence Interval|Geometric Mean
69079|NCT01119443|Secondary|MRTpo,ss (Fasted Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
69080|NCT01119443|Secondary|t1/2,ss (Fasted Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
69081|NCT01119443|Secondary|λz,ss (Fasted Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||/hour||Standard Deviation|Geometric Mean
69082|NCT01119443|Secondary|Tmax,ss (Fasted Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Full Range|Mean
69083|NCT01119443|Secondary|Cmin,ss (Fasted Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
69084|NCT01119443|Secondary|Cτ,ss (Fasted Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Error|Geometric Mean
69085|NCT01119443|Primary|Cmax,ss (Fasted Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
69086|NCT01119443|Primary|AUCτ,ss (Fasted Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
69087|NCT01119443|Secondary|MRTpo,ss (Fed Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
69088|NCT01119443|Secondary|t1/2,ss (Fed Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Standard Deviation|Geometric Mean
69089|NCT01119443|Secondary|λz,ss (Fed Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||per hour||Standard Deviation|Geometric Mean
69090|NCT01119443|Secondary|Tmax,ss (Fed Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||hour||Full Range|Mean
75767|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||12 months||||||
75768|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||6 months||||||
69092|NCT01119443|Secondary|Cτ,ss (Fed Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Error|Geometric Mean
69093|NCT01119443|Primary|Cmax,ss (Fed Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng/mL||Standard Deviation|Geometric Mean
69094|NCT01119443|Primary|AUCτ,ss (Fed Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set||ng·h/mL||Standard Deviation|Geometric Mean
69095|NCT01119287|Primary|Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo|Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison.|Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)|Number of subjects with data available in the specific treatment group||hours x units on a scale||Standard Deviation|Mean
69096|NCT01119287|Primary|Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo|Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison.|Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)|Number of subjects with data available in the specific treatment group||hours x units on a scale||Standard Deviation|Mean
69097|NCT01119222|Secondary|Number of Participants With Abnormal Pulse Oxymetry Results|Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).|Predose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although pulse oxymetry was performed throughout IV dosing, results were not captured for inclusion in the study database.||participants|||Number
69098|NCT01119222|Secondary|Number of Participants With Abnormal Cardiac Monitoring Results|Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).|Pre-dose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although continuous cardiac monitoring was performed throughout IV dosing, results were not captured for inclusion in the study database.||participants|||Number
69099|NCT01119222|Secondary|Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results|Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.|Pre-dose, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.||particpants|||Number
69100|NCT01119222|Secondary|Number of Participants With Abnormal Findings on Electrocardiogram (ECG)|Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.||participants|||Number
69101|NCT01119222|Secondary|Number of Participants With Clinically Significant Abnormal Findings on Physical Examination|Full physical examination consisting of an examination of the abdomen, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected, results were not captured for inclusion in the study database.||participants|||Number
69102|NCT01119222|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Supine blood pressure measured to nearest millimeter of mercury (mmHg), pulse rate measured with automated device or manually in the brachial/radial artery for at least 30 seconds.|Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.||participants|||Number
69103|NCT01119222|Primary|Interpolated Average Pain (0-8 Hours)|Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.|Pre-dose to 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.||hours||Standard Error|Least Squares Mean
69104|NCT01119222|Primary|Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)|"Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of no pain (0) to maximum pain (100) at the anchor endpoints of the scale and moderate pain at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec."|Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.||mm||Standard Deviation|Mean
75769|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||Baseline||||||
69105|NCT01119131|Secondary|Change in Parkinsonism as Measured by the UPDRS|This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson‘s disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms.|Baseline, 16 weeks|Missing data (N = 2), invalid sum due to missing rating (N = 1), not completed due to scheduling conflicts (N = 1).||units on a scale||Standard Deviation|Mean
69106|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).||foot pounds||Standard Deviation|Mean
69107|NCT01119131|Primary|Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1).||units on a scale||Standard Deviation|Mean
69108|NCT01119131|Secondary|Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)|"The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 (Never) to 4 (Always/Cannot Do). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson’s disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life."|Baseline, 16 weeks|Missing data (N = 3), patient forgot form and did not return mailed form (N = 3).||units on a scale||Standard Deviation|Mean
69109|NCT01119131|Secondary|Change in Cognition (Trail Making Test B-A)|The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning.|Baseline, 16 weeks|Missing data (N = 8) due to scheduling difficulties (N = 3), neuropsychological administration errors (N = 2), patient discontinuing (N = 1), maximum time allowance met and discontinued test (N = 2).||seconds||Standard Deviation|Mean
69110|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).||foot pounds||Standard Deviation|Mean
69111|NCT01119131|Primary|Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration|"This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for ON time in Parkinson’s disease. Change score is measurement at 16 weeks minus measurement at baseline."|Baseline and 16 weeks|Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12).||seconds||Standard Deviation|Mean
69112|NCT01119131|Primary|Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=2, test not performed due to participant fatigue.||units on a scale||Standard Deviation|Mean
69113|NCT01119118|Secondary|Number of Subjects With PSA Response||6 months|||participants|||Number
69114|NCT01119118|Secondary|Number of Subjects Whose Tumor Lesion Size Changed Using Iterative Decomposition of Water and Fat With Echo Asymmetry and Least-squares Estimation (IDEAL)-MRI Imaging Alone||Week 6|||participants|||Number
69115|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone||Week 6|||participants|||Number
69116|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone.||Week 6|||participants|||Number
69148|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng・h/mL||Standard Deviation|Mean
69117|NCT01119118|Primary|The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans.|Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.|Week 6|||participants|||Number
69118|NCT01119040|Primary|Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.|Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.|30 day follow-up|Only 1 subject due to low accrual||participants|||Number
69119|NCT01119001|Primary|Accuracy of Typing With a BCI Keyboard by ALS Patients.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.~Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|3 times over 2-4 weeks|||percentage accuracy||Full Range|Mean
69120|NCT01118988|Secondary|Positive and Negative Affect Scale (PANAS)|"assesses extent to which children have felt a number of positive and negative affects~Positive Affect subscale, 12 items, range: 12-60, higher score = more positive affect Negative Affect subscale, 15 items, range: 15-75, higher score = more negative affect"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69121|NCT01118988|Secondary|Child Health Questionnaire - Child Report (CHQ)|"detailed questionnaire about health, daily activites, pain, behavior, family health, self-esteem~Subscales (for all subscales, higher scores = better health):~Behavior - 16 items, averaged, range 1-5 Bodily Pain and Discomfort - 2 items, averaged, range 1-6 Change in Health - 1 item, range 1-5 Family Activities - 6 items, averaged, range 1-5 Family Cohesion - 1 item, range 1-5 Global Health - 1 item, range 1-5 Global Behavior - 1 item, range 1-5 General Health - 12 items, averaged, range 1-5 Mental Health - 16 items, averaged, range 1-5 Physical Functioning - 9 items, averaged, range 1-4 Role/Social Limitations Behavioral - 3 items, range 1-4 Role/Social Limitations Emotional - 3 items, range 1-4 Role/Social Limitations Physical - 3 items, range 1-4 Self-Esteem - 14 items, range 1-5"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69122|NCT01118988|Secondary|Beck Depression Inventory 2 (BDI-2) #18|"assesses suicidal ideation and intent~Number reported is number of participants who reported any level of suicidal ideation or intent at any time and who were followed with the study's emergency protocol to ensure that such participants are not a threat to self or others, and that he/she was under the appropriate mental health care."|baseline, weekly weeks 1-8, 2 months, 4 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||participants|||Number
69123|NCT01118988|Secondary|Revised Child Anxiety and Depression Scale (RCADS) Child Report|"assess levels of symptoms for anxiety disorders and depression~Range: 0-141; Higher scores mean higher symptom level of anxiety and depression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69124|NCT01118988|Secondary|Functional Disability Inventory (FDI)|"assesses functional disability for daily tasks~Range: 0-60; higher scores mean greater functional disability."|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69125|NCT01118988|Secondary|Emotion Expression Scale for Children (EESC)|"assess child emotional expression/emotion regulation~Poor Awareness subscale, 8 items, range: 8-40; higher scores = poorer emotional awareness Expressive Reluctance subscale, 8 items, range: 8-40; higher scores = more expressive reluctance"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69126|NCT01118988|Secondary|Emotion Regulation Questionnaire (ERQ) - Child Answer|"assessment of child emotion regulation~Reappraisal subscale: 6 items, range 6-30, higher scores = higher use of reappraisal Suppression subscale: 4 items, range: 4-20, higher scores = higher use of suppression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69127|NCT01118988|Secondary|Health Belief Scale (HBS) Short Version - Child Report|Number of treatment modalities rated 1-4 by participants on the HBS questionnaire, which asked participants to rate how much they think each of 16 listed treatment modalities would help with pain (1=Completely, 2=A lot, 3=Some, 4=A little, 5=Not at all).|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||Number of treatments||Standard Deviation|Mean
69128|NCT01118988|Secondary|Child Anxiety Sensitivity Inventory (CASI) - Child Report|"Assessment of child's anxiety sensitivity~18 items, range 18-54, higher scores = more anxiety sensitivity"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69129|NCT01118988|Secondary|Child Symptom Inventory (CSI)|"Assement of somatic symptom complaints~24 items, range 0-96, higher score = more somatic symptoms"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
69130|NCT01118988|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"assessment of sleep quality~Range: 0-21; higher scores = lower sleep quality"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||units on a scale||Standard Deviation|Mean
75770|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale.||Baseline||||||
69131|NCT01118988|Secondary|Body Map and Pain Assessment|"visual depiction of body pain and associated pain ratings over certain periods of time and conditional situations~Range: 0-19 body areas"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.||Number of painful body areas||Standard Deviation|Mean
69132|NCT01118988|Primary|Adherence to Physician Recommended CAM Therapies|This measure tracks the attendance of CAM therapies recommended by the subjects' pain specialist physician.|post intervention (week 8)|One participant in the Mentorship group did not do the weekly CAM therapy tracking and is thus not included in the results for this measure.||Visits to CAM therapists per week||Standard Deviation|Mean
69133|NCT01118975|Primary|Clinical Benefit Rate|The Clinical Benefit Rate is the number of patients with either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for ≥ 6 months|Radiological evaluations are performed every 12 weeks to determine disease status|||participants|||Number
69134|NCT01118975|Primary|Dose Limiting Toxicities|Safety and tolerability were assessed. Adverse events and dose limiting toxicities were recorded during an escalting dose pilot phase.|6 weeks|||Dose limiting toxicities|||Number
69135|NCT01118962|Primary|Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."||participants|||Number
69136|NCT01118962|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."||participants|||Number
69137|NCT01118949|Secondary|Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.||participants|||Number
69138|NCT01118949|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.||participants|||Number
69139|NCT01118949|Secondary|Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.||1/hour||Standard Deviation|Mean
69140|NCT01118949|Secondary|Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.||1/hour||Standard Deviation|Mean
69141|NCT01118949|Primary|Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:~Seizure type~Seizure frequency~A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.||number of seizure days||Standard Deviation|Mean
69142|NCT01118949|Primary|Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:~Seizure type~Seizure frequency~A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.||number of seizure days||Standard Deviation|Mean
69143|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
69144|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng・h/mL||Standard Deviation|Mean
69145|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
69146|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng/mL||Standard Deviation|Mean
69147|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||hour||Standard Deviation|Median
69150|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle|||ng/mL||Standard Deviation|Mean
69151|NCT01118845|Secondary|Concomitant Medication Usage||up to 30 weeks|||Participants|||Number
69152|NCT01118845|Secondary|Number of Subjects With Grade ≥3 Physical Examination Finding||up to 30 weeks|||Participants|||Number
69153|NCT01118845|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE).~grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event"|up to 30 weeks|||Participants|||Number
69154|NCT01118845|Secondary|Number of Adverse Events||up to 30 weeks|||Events|||Number
69155|NCT01118845|Secondary|Number of Subjects With Adverse Event||up to 30 weeks|||Participants|||Number
69156|NCT01118845|Secondary|Progression Free Survival (PFS)|"PFS = day of the first PFS event - day of start of study treatment + 1~The definitions of PFS event are as below.~PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma~PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) >1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement~Disease progression during treatment period~Disease progression during follow up period~Start of treatment of new lesion~Occurrence of other multiple malignant tumors~Death"|up to 30 weeks|||Days||95% Confidence Interval|Median
69157|NCT01118845|Secondary|The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"The criteria for CR is as below~Nodal Masses:~fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative~Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT)~Spleen, Liver:~Not palpable, nodules disappeared~Bone Marrow:~Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative"|up to 30 weeks|||Percentage of participants||95% Confidence Interval|Number
69158|NCT01118845|Primary|The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites.~For the criteria for CR, See Outcome measure 2 description.~The criteria for PR is as below.~Nodal Masses:~more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT~Spleen, Liver:~more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen~Bone Marrow:~Irrelevant if positive prior to therapy; cell type should be specified"|up to 30 weeks|||Percentage of Participants||95% Confidence Interval|Number
69159|NCT01118780|Secondary|Time to First Improvement|The time (days) to first improvement, defined as a Clinical Global Impression of Improvement (CGI-Improvement) Score ≤2. Participants who did not have a CGI-I Score ≤2 were censored at the last treatment period visit. CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). A CGI-Improvement Score of ≤2 was much improved or very much improved.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=37 participants in the duloxetine treatment arm and n=58 participants in the placebo treatment arm.||days||95% Confidence Interval|Median
69160|NCT01118780|Secondary|Time to First Functional Remission|Time (days) to first functional remission. Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). Participants, who did not have an SDS Global Score ≤5 or ≤6, were censored at the last treatment period visit. The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Baseline through 10 weeks|All randomized participants (pts). Number of pts censored (n)=50 pts in duloxetine treatment arm and n=73 pts in placebo treatment arm for time to first functional remission (SDS Global Score ≤5) and n=37 pts in duloxetine treatment arm and n=60 pts in placebo treatment arm time to first functional remission (SDS Global Score ≤6).||days||95% Confidence Interval|Median
69161|NCT01118780|Secondary|Time to Sustained Improvement Overall|Time (days) to the earliest visit at which the Hamilton Anxiety Rating Scale (HAMA) Total Score was a ≥30% improvement (reduction) from baseline that was sustained through the last treatment period visit. Participants who did not meet sustained improvement criteria were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=43 participants in the duloxetine treatment arm and n=63 participants in the placebo treatment arm.||days||95% Confidence Interval|Median
69222|NCT01118273|Secondary|Overall Rating of Pain Relief|"Subjects responded to question, Overall, the relief from my starting pain was by checking one of the following choices: no relief (0), a little relief (1), some relief (2), a lot of relief (3), complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
69639|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
69162|NCT01118780|Secondary|Time to First Remission|The time (days) to first remission. Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score, were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). Participants who did not have remission were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants (pts). The number of censored pts (n)=72 pts in the duloxetine treatment arm and n=92 pts in the placebo treatment arm for time to first remission (HAMA Total Score ≤7) and n=49 pts in the duloxetine treatment arm and n=71 pts in the placebo treatment arm for the time to first remission (HAMA Total Score ≤10).||days||95% Confidence Interval|Median
69163|NCT01118780|Secondary|Time to First Response|The time (days) to first response, defined as a ≥50% improvement (reduction) from baseline in the Hamilton Anxiety Rating Scale (HAMA) Total Score. Participants who did not have a response were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of censored participants (n)=36 participants in the duloxetine treatment arm and n=60 participants in the placebo treatment arm.||days||95% Confidence Interval|Median
69164|NCT01118780|Other Pre-specified|Number of Participants Experiencing a Treatment-Emergent Adverse Event (AE) During the Taper Period|Treatment-emergent AEs were newly occurring AEs or a worsening of AEs during the taper period. A summary of serious AEs and other AEs during the treatment period (baseline through 10 weeks) is located in the Reported Adverse Events module.|2 weeks during the taper period|Randomized participants who entered the taper period.||participants|||Number
69165|NCT01118780|Secondary|Percentage of Participants Reporting Falling Down|The percentage of participants who reported 1 or more falls at or before Week 10.|Baseline through 10 weeks|Randomized participants with no falls recorded at Baseline and at least 1 post-baseline assessment for falls.||percentage of participants|||Number
69166|NCT01118780|Secondary|Adverse Events (AEs) Leading to Discontinuation From Study|The number of participants who discontinued from the study due to an AE (serious or other AE) during the treatment period. A summary of serious and other AEs is located in the Reported Adverse Events module.|Baseline through 10 weeks|All randomized participants.||participants|||Number
69167|NCT01118780|Secondary|Percentage of Participants With Sustained Improvement (Sustained Improvement Rate)|Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score at endpoint compared with baseline, were used to determine sustained improvement: Definition 1 [sustained improvement overall required a ≥30% improvement (reduction) in the HAMA Total Score at treatment period endpoint, at an earlier visit prior to endpoint, and at all visits in between] and Definition 2 (sustained improvement from Week 2 required a ≥30% reduction at treatment period endpoint, at Week 2, and at all visits in between). Both definitions required at least 2 post-baseline visits. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|(Baseline through 10 weeks) and (Baseline, Week 2 through Week 10)|Randomized participants who had baseline and the required number of post-baseline HAMA Total Scores.||percentage of participants|||Number
69168|NCT01118780|Secondary|Percentage of Participants With Functional Remission at Week 10 (Functional Remission Rate)|Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Week 10|All randomized participants with at least 1 post-baseline SDS Global Score; Last observation carried forward (LOCF).||percentage of participants|||Number
69169|NCT01118780|Secondary|Percentage of Participants With Response or Remission at Week 10 (Response and Remission Rates)|Response was a ≥50% improvement (reduction) in the Hamilton Anxiety Rating Scale (HAMA) Total Score at treatment period endpoint compared with baseline. Two definitions were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline, Week 10|Randomized participants with a baseline and 1 post-baseline HAMA Total Score; Last observation carried forward (LOCF).||percentage of participants|||Number
69170|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Work/School, Social Life, and Family/Home Management Individual Impairment Scores|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Work/School, Social Life/Leisure Activities, or Family/Home Management Individual Impairment Scores.||units on a scale||Standard Error|Least Squares Mean
92745|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).||Baseline up to Month 7|||percentage of participants|||Number
69171|NCT01118780|Secondary|Number of Participants With Treatment-Emergent Suicide-Related Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent was the worsening or new occurrence of suicidal behavior or ideation during treatment compared with baseline (Week 0)."|Baseline through 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS Score.||participants|||Number
69172|NCT01118780|Secondary|Change From Baseline to Week 10 in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Score|The Q-LES-Q-SF was a participant-rated questionnaire designed to assess the degree of enjoyment and satisfaction experienced during the past week. The questionnaire consisted of 16 items rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total raw score was the sum of Items 1 to 14 and could have ranged from 14 to 70. Total raw scores were converted to, and expressed as, the percentage of the maximum possible score. Percent=100*(total raw score – 14)/56. Higher scores indicated higher levels of enjoyment/satisfaction. Least squares (LS) mean were calculated and analyzed using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator, age category, and baseline.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; Last observation carried forward (LOCF).||percent of maximum possible score||Standard Error|Least Squares Mean
69173|NCT01118780|Secondary|Change From Baseline to Week 10 in Brief Pain Inventory-Modified Short Form (BPI-SF) Pain Severity and Interference Subscales|The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions assessing worst pain, least pain, and average pain in the past 24 hours, and pain right now. The BPI-SF Interference Subscale measured the interference of pain with the participant's ability to function. Interference scores could have ranged from 0 (does not interfere) to 10 (completely interferes) for questions assessing interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least squares (LS) means were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline BPI-SF Pain Severity or Interference Subscale Score.||units on a scale||Standard Error|Least Squares Mean
69174|NCT01118780|Secondary|Patient's Global Impressions of Improvement Scale (PGI-Improvement) at Week 10|PGI-Improvement measured the participant's perception of his or her improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much better) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline PGI-Improvement Score.||units on a scale||Standard Error|Least Squares Mean
69175|NCT01118780|Secondary|Clinical Global Impressions of Improvement Scale (CGI-Improvement) at Week 10|CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline CGI-Improvement Score.||units on a scale||Standard Error|Least Squares Mean
69176|NCT01118780|Secondary|Change From Baseline to Week 10 Endpoint in Hospital Anxiety Depression Scale (HADS) Subscale Scores|HADS was a 14-item questionnaire with 2 subscales (anxiety and depression). Each item was rated on a 4-point scale (0 to 3) and higher scores indicated a greater dysfunction. The HADS Anxiety Subscale Score was the sum of the odd numbered items and scores could have ranged from 0 to 21. The HADS Depression Subscale Score was the sum of the even numbered items and scores could have ranged from 0 to 21. Higher scores indicated a greater dysfunction. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HADS Subscale Score.||units on a scale||Standard Error|Least Squares Mean
69177|NCT01118780|Secondary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) (Psychic Anxiety Factor Score, Somatic Anxiety Factor Score, and Individual Item Scores: Anxious Mood Item and Tension Item)|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Psychic Anxiety Factor Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28. The HAMA Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28. The HAMA Anxious Mood Item Score was the score for Item 1 and the HAMA Tension Item Score was the score for Item 2. In each case, higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA factor or item score.||units on a scale||Standard Error|Least Squares Mean
69178|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Global Functional Impairment Score|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Global Functional Impairment Score.||units on a scale||Standard Error|Least Squares Mean
69179|NCT01118780|Primary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) Total Score|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA Total Score.||units on a scale||Standard Error|Least Squares Mean
69180|NCT01118741|Secondary|Clinical Response|To assess the clinical response measured by prostate specific antigen (PSA) progression at 6 months after treatment with the defined dose of disulfiram in prostate cancer (PCa) patients with evidence of biochemical relapse after local therapy|After 6 months||||||
69181|NCT01118741|Primary|Proportion of Subjects With a Demethylation Response at Each Dose Level|For both of the doses explored (i.e. disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed. A demethylation response was defined as a >=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.|24 months|||proportion of participants||95% Confidence Interval|Number
69182|NCT01118663|Secondary|To Evaluate the Incidence of Anaphylactoid Reaction.|Data analysis was conducted on the subjects enrolled in the study prior to study termination. Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|1 hour|||participants|||Number
69183|NCT01118663|Secondary|To Evaluate the Incidence of Treatment Emergent Adverse Events||21-42 hours|||Number of Events|||Number
69184|NCT01118663|Secondary|To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|42 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.|||||
69185|NCT01118663|Secondary|To Evaluate the Percentage of Subjects Requiring Continued Therapy|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.|||||
69186|NCT01118663|Primary|The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.|||||
69187|NCT01118624|Secondary|Incidence of Adverse Events (AEs) and Laboratory Abnormalities||Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal).|||participants|||Number
69188|NCT01118624|Secondary|Overall Survival (OS)|Number of days from first dose of pralatrexate to death.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate.|||months||95% Confidence Interval|Median
69189|NCT01118624|Secondary|Duration of Response (DOR)|One patient has a PR as response and duration of response was provided for that patient.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.|||days|||Number
69190|NCT01118624|Primary|Objective Response Rate (ORR)|Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.|||participants|||Number
69191|NCT01118455|Secondary|Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks|||participants|||Number
69192|NCT01118455|Secondary|Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks|"Number of participants with any definite related Adverse Event by body system and preferred term, Safety Population.~NOTE: Number of participants analyzed in VNS arm includes one explant not from ITT population, but from safety population."||Participants|||Number
69193|NCT01118455|Secondary|Mean Percent Change in Seizure Frequency (ITT Population)|"The mean percent change in seizure frequency for the VNS and AED treatment groups at 52 weeks post baseline.~Both AED and VNS treatment groups were stratified according to the patients' number of previous AED treatments (early group had 2 to 5 AEDs tested to tolerance or to blood levels at upper end of target range; non-early group had more than 5 AEDs tested to tolerance or to blood levels at upper end of target range). Seizure frequency was calculated based on number of patient/caregiver reported seizures at 52-week post baseline (percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%). All seizures were counted.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|52 weeks post baseline|||Percent Change||Standard Deviation|Mean
69194|NCT01118455|Secondary|Hague Restriction in Childhood Epilepsy Scale (Questionnaire B) (ITT Population)|"Calculate changes in the Hague Restriction in Childhood Epilepsy scale (Carpay et al. 1997) (Questionnaire B) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.~An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.~Total range for this scale is a minimum score of 10 to a maximum score of 40. There are no applicable subscales."|52 weeks post baseline|||Scores on a Scale||Standard Deviation|Mean
69195|NCT01118455|Secondary|Wellcome Quality of Life Assessment (Questionnaire A) in Epilepsy (ITT Population)|"Calculate changes in the Wellcome Quality of Life Assessment (Parker et al. 1999) (Questionnaire A) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.~An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.~Total range for this scale is a minimum score of 81 to a maximum score of 336. There are no applicable subscales."|52 weeks post baseline|||Scores on a Scale||Standard Deviation|Mean
69196|NCT01118455|Secondary|Mean Percent Change in Hague Seizure Severity Scale Score (ITT Population)|The Hague Seizure Severity Assessment (Carpay et al. 1996) is a scale completed by the patient and/or caregiver to assess the severity and post-ictal recovery of seizures. A reduction in the HSSA score reflects less seizure severity experienced.|52 weeks post baseline|||Percent Change||Standard Deviation|Mean
69197|NCT01118455|Primary|Proportion of Responders After 1 Year of Follow-up (ITT-population)|Responders are subjects who had no new AEDs added or significant dose changes in baseline AEDs within 1 year of follow-up, along with a reduction in the percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%.|52 weeks post baseline|Subjects were stratified based on AED therapy history (Early: treated with 2 to 5 AEDs versus Non-early: treated with >5 AEDs).||percentage of responders|||Number
69198|NCT01118377|Secondary|Percentage of Participants With a Tumor Response|Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.||Percentage of participants||95% Confidence Interval|Number
69199|NCT01118377|Secondary|Overall Survival|Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.||Months||95% Confidence Interval|Median
69200|NCT01118377|Primary|Progression-free Survival|Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.||Months||95% Confidence Interval|Median
69201|NCT01118325|Secondary|AR-C124910XX (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||hour||Full Range|Median
69202|NCT01118325|Secondary|AR-C124910XX (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||ng.h/mL||Standard Deviation|Geometric Mean
69203|NCT01118325|Secondary|AR-C124910XX (Cmax) at Week 4|Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||ng/mL||Standard Deviation|Geometric Mean
69204|NCT01118325|Secondary|AZD6140 (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||hour||Full Range|Median
69205|NCT01118325|Secondary|AZD6140 (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.||ng.h/mL||Standard Deviation|Geometric Mean
69206|NCT01118325|Secondary|AZD6140 (Cmax) at Week 4|Maximum plasma AZD6140 concentration|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis||ng/mL||Standard Deviation|Geometric Mean
76742|NCT01034397|Secondary|Change From Baseline to Week 12 in Plasma Adrenocorticotrophic Hormone (ACTH)|Change in Plasma ACTH was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
69207|NCT01118325|Primary|IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
69208|NCT01118325|Primary|IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
69209|NCT01118325|Primary|IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
69210|NCT01118325|Primary|IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
69211|NCT01118325|Primary|Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan||percentage inhibition||Standard Deviation|Mean
69212|NCT01118312|Secondary|Childhood Asthma Control Test|Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control|24 weeks|Analysis of Children (less than 18 years old) Childhood Asthma Control Test scores||units on a scale||Standard Error|Mean
69213|NCT01118312|Primary|Asthma Control Test (ACT)|Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control|24 weeks|Analysis of adult (18 and above) Asthma Control Scores||units on a scale||Standard Error|Mean
69214|NCT01118273|Secondary|Wake Episode Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).|Up to 10 hours|||Wake episodes||95% Confidence Interval|Least Squares Mean
69215|NCT01118273|Secondary|Activity Mean Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Activity mean - average movement per minute.|Up to 10 hours|ITT (Intent to Treat) Population||Movement per minute||95% Confidence Interval|Least Squares Mean
69216|NCT01118273|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Percentage of sleep time||95% Confidence Interval|Least Squares Mean
69217|NCT01118273|Secondary|Total Wake Time Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
69218|NCT01118273|Secondary|Number of Times Participants Took Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
69219|NCT01118273|Secondary|Global Assessment of Study Medication as a Pain Reliever|Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
69220|NCT01118273|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study."|Up to 10 hours|ITT (Intent to Treat) Population||Participants|||Number
69221|NCT01118273|Secondary|Time to Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment."|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Median
69223|NCT01118273|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score|Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
69224|NCT01118273|Secondary|Overall Rating of Severity in Visual Analog Scale (VAS) Score|Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.|At 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
69225|NCT01118273|Secondary|Change From Baseline in Categorical Pain Rating Scale Score|Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
69226|NCT01118273|Secondary|Overall Rating of Severity in Categorical Pain Rating Scale Score|Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).|Up to 10 hours|ITT (Intent to Treat) Population||Scores on a scale||Standard Deviation|Mean
69227|NCT01118273|Secondary|Sleep Quality Index|Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed).||Scores on a scale||95% Confidence Interval|Least Squares Mean
69228|NCT01118273|Secondary|Total Sleep Time by Subject Assessment|Subject responded to: Please estimate the number of hours and minutes you think that you slept.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
69229|NCT01118273|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69230|NCT01118273|Secondary|Karolinska Sleep Diary - Well Rested|Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69231|NCT01118273|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69232|NCT01118273|Secondary|Karolinska Sleep Diary - Premature Awakening|Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69233|NCT01118273|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69234|NCT01118273|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69235|NCT01118273|Secondary|Karolinska Sleep Diary - Sleep Quality|Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69236|NCT01118273|Secondary|Global Assessment of Study Medication as a Sleep-aid|Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)||Participants|||Number
69237|NCT01118273|Secondary|Sleep Latency Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
69238|NCT01118273|Secondary|Wake After Sleep Onset (WASO) Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
69239|NCT01118273|Primary|Total Sleep Time Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as “awake” from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.|Up to 10 hours|ITT (Intent to Treat) Population||Minutes||95% Confidence Interval|Least Squares Mean
69240|NCT01118221|Secondary|Maximum Oxygen Uptake|Change in 6 peak O2 uptake from Baseline to 3 Months|Maximum O2 uptake will be measured at 0 and 3 months.|||mL/minute||Standard Error|Mean
69241|NCT01118221|Secondary|Systemic Markers of Oxidant Stress|Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.|Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.|||pg/mL||Standard Deviation|Mean
69242|NCT01118221|Primary|6 Minute Walk Distance|Change in 6 Minute Walk Distance from Baseline to 3 Months|The 6-MWD will be measured at 0 and 3 months.|||meters||Standard Deviation|Mean
69243|NCT01118143|Secondary|Plaque Index|"The plaque index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = low accumulation of plaque; 1.1-2.0 = Moderate accumulation of plaque; 2.1-3.0 = high accumulation of plaque.~The Plaque index reference is Silness and Löe, 1964."|6 months after intervention|||units on a scale||Standard Deviation|Mean
69244|NCT01118143|Primary|Gingival Index|The gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.|6 months after intervention|||units on a scale||Standard Deviation|Mean
69245|NCT01118117|Secondary|Stent Fracture at 12 Months|Occurrence of stent fracture as determined by core laboratory analysis|12 Months post-procedure|X-rays for 324 stents (234 subjects) were available for analysis by the angiographic core laboratory to evaluate stent fractures at 12 months post-procedure. One stent fracture was caused by a physician during a non-study peripheral intervention.||percentage of fracture occurrence|Participants||Number
69246|NCT01118117|Secondary|Major Adverse Events (MAEs) Through 12 Months Post-procedure|The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.|12 Months post-procedure|||percentage of subjects with event|||Number
69247|NCT01118117|Secondary|Clinical Success|Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline|30 days post-procedure|||percentage of subjects with success|||Number
69248|NCT01118117|Secondary|Procedural Success|Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel|Intra-procedure|||percentage of subjects with success|||Number
69249|NCT01118117|Secondary|Technical Success|"Technical Success defined by the following conditions:~Successful delivery of the stent at the lesion site~Stent(s) successfully deployed in lesion with adequate lesion coverage"|Intra-procedure|All subjects enrolled in pivotal trial||percentage of subjects with success|||Number
69250|NCT01118117|Secondary|Device Related Peri-Procedural Complications|Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)|Prior to Hosptial Discharge|All enrolled participants evaluated prior to hospital discharge||percentage of subjects with event|||Number
69251|NCT01118117|Secondary|Occurrence of Target Lesion Revascularization|"The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure.~Clinically driven defined as:~More than 50 percent stenosis with worsening symptoms, OR~More than 70 percent stenosis without symptoms"|12 Months post-procedure|Comprised of all subjects enrolled in the pivotal OSPREY trial (N=261)||percentage of subjects with TLR|||Number
69252|NCT01118117|Secondary|Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort|The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)|12 Months post-procedure|Analysis uses a more contemporary approach to evaluate primary stent patency using a peak systolic velocity ratio ≤ 2.4 (modified VIVA criteria). Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success in the analysis.||percentage of stent patency|||Number
69253|NCT01118117|Primary|Primary Safety Endpoint|The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.|30 days post-procedure|Study success was based on the proportion of patients with freedom from MAE at 30 days post-procedure when tested against a performance goal of 88% using the lower bound of the 95% confidence interval. In both cohorts, the lower confidence interval exceeded the prespecified performance goal indicating the study met its primary safety endpoint.||percentage of subjects without a MAE||95% Confidence Interval|Number
69254|NCT01118117|Secondary|Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort|Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).|12 Months post-procedure|The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).||percentage of stent patency|||Number
69255|NCT01118117|Primary|Primary Effectiveness Endpoint|The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.|12 Months post-procedure|Analysis comprised of 261 subjects enrolled in pivotal trial and missing data imputed as loss of patency under the intention-to-treat (ITT) analysis. Study success was based on the proportion of patients with stent patency when tested against a performance goal of 66% using the lower bound of the 95% confidence interval.||percentage of stent patency||95% Confidence Interval|Number
69256|NCT01118091|Primary|Progression Free Survival|Measured from the time of randomization to time of progression (or death).|3 years|||Days|||Number
69257|NCT01118091|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 years|||Participants|||Number
69270|NCT01117766|Secondary|Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7|Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to “How intense is your pain today?”|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
69258|NCT01118091|Primary|Response Rate|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 years|||Participants|||Number
69259|NCT01117987|Secondary|Percentage of Participants With Incidence of Clinical Worsening Events|Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.|204 weeks|Full Analysis Set (FAS): The full analysis set included all participants who received at least one dose of study drug during the extension.||Percentage of participants|||Number
69260|NCT01117987|Secondary|Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)|A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).|core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks|Participants from the Full Analysis Set (FAS), who had values at both core study baseline and the given post-baseline time point, were included in the analysis for that post-baseline time point. The FAS included all participants who received at least one dose of study drug during the extension.||meters||Standard Deviation|Mean
69261|NCT01117987|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|204 weeks|Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.||Participants|||Number
69262|NCT01117948|Secondary|Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI||6 months double-blind, 6 months open label (optional)||||||
69263|NCT01117948|Primary|Cognitive Performance - ADAS-cog+|"Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items).~Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind)."|6 months double blind, 6 months open-label (optional)|||units on a scale||Standard Deviation|Mean
69264|NCT01117857|Other Pre-specified|Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)|The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
69265|NCT01117857|Other Pre-specified|Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)|The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
69266|NCT01117857|Other Pre-specified|Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)|The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
69267|NCT01117857|Secondary|Change in Menopause Symptoms as Measured by the Greene Climacteric Scale|The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
69268|NCT01117857|Primary|Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression|The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.||units on a scale||Inter-Quartile Range|Median
69269|NCT01117766|Secondary|Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7|NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 4 (Visits 4 and 7) of each period|FAS. n=18, 18; number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
69271|NCT01117766|Secondary|Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7|PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
69272|NCT01117766|Secondary|Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7|Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF).||scores on a scale||Standard Deviation|Mean
69273|NCT01117766|Primary|Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.||scores on a scale||Standard Deviation|Mean
69274|NCT01117766|Primary|Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.||scores on a scale||Standard Deviation|Mean
69275|NCT01117766|Primary|Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||cm2||Standard Deviation|Mean
69276|NCT01117766|Primary|Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.||scores on a scale||Standard Deviation|Mean
69277|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7|Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.||cm2||Standard Deviation|Mean
69278|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7|Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a “strange” or “tickly” sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|Full analysis set (FAS)=participants with present pain intensity score >=4 out of 10 for brush evoked allodynia at screening and randomization, >=4 out of 7 non missing values in week prior to randomization, >4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean.||scores on a scale||Standard Deviation|Mean
69279|NCT01117727|Primary|Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning|Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .|8 sessions over 2 months|||percent of correct targets selected|||Number
69289|NCT01117623|Secondary|Ratio of Cmax,ss/Cmax (RACmax)|RACmax is the ratio of the highest drug concentration at steady state to the highest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss and Cmax in at least one analyte were 1 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||Ratio|||Number
69280|NCT01117623|Other Pre-specified|Tumor Response in Expansion Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only||Participants|||Number
69281|NCT01117623|Other Pre-specified|Tumor Response in Dose Escalation Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set)||Participants|||Number
69282|NCT01117623|Other Pre-specified|Tumor Progression in Expansion Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only||Participants|||Number
69283|NCT01117623|Other Pre-specified|Tumor Progression in Dose Escalation Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|Intent-to-treat (ITT) efficacy analysis (set)||Participants|||Number
69284|NCT01117623|Secondary|Biomarker Soluble Vascular Endothelial Growth Factor Receptor 2 (sCEGFR-2) Plasma Levels|The analysis of Biomarker sCEGFR-2 plasma levels is not done.|No data obtained|ITT|||||
69285|NCT01117623|Secondary|Biomarker Vascular Endothelial Growth Factor (VEGF) Plasma Levels|The analysis of Biomarker VEGF plasma levels is not done|No data obtained|ITT|||||
69286|NCT01117623|Secondary|Ratio of AUCt,ss/AUC (RLIN)|RLIN is the ratio of the measure of systemic drug exposure at steady state to the measure of systemic drug exposure after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|PK population; Number of Participants with an evaluable AUCt,ss and AUC in at least one analyte were 0 in 20mg; 3 (regorafenib) and 4 (M2) in 40mg; 3 in 100 mg; 2 (regorafenib) and 0 (M2) in 120 mg; 3 (regorafenib) and 2 (M2) in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 4 in NSCLC; No participants have evaluable data for M5.||Ratio|||Number
69287|NCT01117623|Secondary|Ratio of AUCt,ss/AUCt (RAAUC)|RAAUC is the ratio of the measure of systemic drug exposure over a specific dosing interval at steady state to the measure of systemic drug exposure over a specific dosing interval after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUCt,ss and AUCt in at least one analyte were 0 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||Ratio|||Number
69288|NCT01117623|Secondary|Ratio of Cmin,ss/Cmin (RACmin)|RACmin is the ratio of the lowest drug concentration at steady state to the lowest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmin,ss and Cmin in at least one analyte were 0 (M5) in 20mg; 6 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||Ratio|||Number
69320|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period|Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percentage of participants|||Number
69290|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)|Tmax,ss refers to the time after multiple dose administration and after a steady state concentration has been reached when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Tmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||h||Full Range|Median
69291|NCT01117623|Secondary|AUC From Time 0 to 24 Hours at Steady State Divided by Dose (AUC(0-24)ss/D)|AUC(0-24)ss/D is a measure of systemic drug exposure (AUC) over 24 hours after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24)ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||h/L||Geometric Coefficient of Variation|Geometric Mean
69292|NCT01117623|Secondary|Cmax at Steady State During a Dosing Interval Divided by Dose (Cmax,ss/D)|Cmax,ss/D refers to the highest measured drug concentration after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||1/L||Geometric Coefficient of Variation|Geometric Mean
69293|NCT01117623|Secondary|Half-life Associated With the Terminal Slope (T1/2)|T1/2 is the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|PK population; Number of Patients with at least an evaluable T1/2 were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (regorafenib and M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10(M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC||h||Geometric Coefficient of Variation|Geometric Mean
69294|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Tmax in at least one analyte were 1 (M-5) in 20 mg; 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M-5) in NSCLC||h||Full Range|Median
69295|NCT01117623|Secondary|Maximum Observed Plasma Concentration After Single Dose Administration Divided by Dose (Cmax/D)|Cmax/D refers to the highest measured drug concentration after a single dose administration, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax/D in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC||1/L||Geometric Coefficient of Variation|Geometric Mean
69296|NCT01117623|Secondary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose Divided by Dose (AUC/D)|The AUC/D is a measure of systemic drug exposure (AUC) after the first single dose, which is then divided by that dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC/D were 5 (regorafenib) and 6 (M-2) in 40mg; 5 (regorafenib and M-2) in 100 mg; 3 (M-2) in 120 mg; 6 (regorafenib and M-2) in 140 mg; 9 (regorafenib), 10 (M-2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M-2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M-2) in NSCLC||h/L||Geometric Coefficient of Variation|Geometric Mean
69297|NCT01117623|Secondary|AUC From Time 0 to the Last Data Point > Lower Limit of Quantification (LLOQ) (AUC(0-tlast))|The AUC(0-tlast) is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-tlast) in at least one analyte were 1(M-5) in 20mg; 7 (regorafenib and M-2) and 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M5) in NSCLC||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
69298|NCT01117623|Primary|AUC From Time 0 to 24 Hours at Steady State(AUC(0-24),ss)|AUC(0-24),ss is a measure of systemic drug exposure over 24 hours, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24),ss in at least one analyte in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
69299|NCT01117623|Primary|Cmax at Steady State During a Dosing Interval (Cmax,ss)|Cmax,ss refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC||mg/L||Geometric Coefficient of Variation|Geometric Mean
69300|NCT01117623|Primary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose (AUC)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10 (M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
69301|NCT01117623|Primary|Maximum Observed Plasma Concentration After Single Dose Administration (Cmax)|Cmax refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC||mg/L||Geometric Coefficient of Variation|Geometric Mean
69302|NCT01117623|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level, which could be given to 6 participants such that no more than 1 participant (less than 33%) experienced a dose-limiting toxicity (DLT).|Within first 4 weeks of treatment|Safety Population; dose escalation cohorts only||mg|||Number
69303|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)|The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 3 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI.||units on a scale||Standard Deviation|Mean
69304|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ.||units on a scale||Standard Deviation|Mean
69305|NCT01117480|Primary|Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject’s Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28.||percentage of participants|||Number
69306|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.~Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:~The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),~Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the extension period (from week 24 to week 48)|The population analyzed was the safety population (extension) i.e. all treated patients during the extension period.||participants|||Number
69321|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period|"Percentage of patients with:~* HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value~AND~* HbA1c value at end of the comparative period (LOCF) ≥7%"|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percentage of participants|||Number
69307|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.~Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:~The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),~Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the comparative period (from week 0 to week 24)|The population analyzed was the safety population i.e. all randomized and treated patients.||participants|||Number
69308|NCT01117350|Secondary|Daily Dose of Insulin Glargine Administered During the Extension Period||week 30, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this mITT population were analyzed at each week.||Unit (U)||Standard Deviation|Mean
69309|NCT01117350|Secondary|Daily Dose of Liraglutide||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.||mg||Standard Deviation|Mean
69310|NCT01117350|Secondary|Daily Dose of Insulin Glargine||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.||Unit (U)||Standard Deviation|Mean
69311|NCT01117350|Secondary|Body Weight: Change From Beginning to End of the Extension Period|Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the mITT population (extension).||kg||Standard Deviation|Mean
69312|NCT01117350|Secondary|Body Weight: Change From Baseline to the End of the Comparative Period|Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline|baseline (week 0), week 2, week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one weight value on treatment during the comparative period.||kg||Standard Deviation|Mean
69313|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value"|week 24, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this population were analyzed for each time point of the profile.||mg/dL||Standard Deviation|Mean
69314|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value"|baseline (week 0), week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed for each time point of the profile.||mg/dL||Standard Deviation|Mean
69315|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value"|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT (extension) patients who had SMFPG value both at beginning of the extension and at least one value on treatment during the extension period.||mg/dL||Standard Deviation|Mean
69316|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value"|baseline (week 0), week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one SMFPG value on treatment during the comparative period.||mg/dL||Standard Deviation|Mean
69317|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period|Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)|week 36, week 48|The population analyzed for this outcome measure consisted of the mITT patients who had at least one HbA1c value on treatment during the extension period.||percentage of participants|||Number
69318|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period|Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value|week 24, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT population (extension) who had HbA1c value both at beginning of the extension and at least one value on treatment during the extension period.||percent||Standard Deviation|Mean
69319|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period|Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percent||Standard Deviation|Mean
69322|NCT01117350|Primary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period|The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value).|week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.||percentage of participants|||Number
69323|NCT01117337|Secondary|Seroma Formation|A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day.|One year|||Participant|||Number
69324|NCT01117337|Primary|Proportion of Patients Having Pain in the Post Operative Period|To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.|1 month|||Participant|||Number
69325|NCT01117337|Primary|Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.|Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.|1 year|||Participant|||Number
69326|NCT01117311|Secondary|Gastric Emptying Half-time|Gastric emptying half time is the time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested|||minutes||Standard Error|Mean
69327|NCT01117311|Primary|Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|baseline, 2 weeks|||10^-14dl/kg/min^2 per pmol/l||Standard Error|Mean
69328|NCT01117181|Secondary|Electrocardiogram (ECG)|Abnormal electrocardiogram results at 6 weeks|6 weeks|||participants with abnormal ECG|||Number
69329|NCT01117181|Secondary|Electrolytes|Percent abnormal at 6 weeks as assessed by local lab|6 weeks|One patient in the active group completed all visit 6 assessments except for the blood collection for the electrolyte sample. This patient refused this procedure.||percentage of abnormal electrolyte value|||Number
69330|NCT01117181|Secondary|Vital Status|vital status as measured by death|vital status at 6 weeks|||number of participants who died|||Number
69331|NCT01117181|Secondary|Neuropsychiatric Inventory (NPI): Apathy Subscale|Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance.|baseline to week 6|||change in NPI apathy score||Standard Error|Mean
69332|NCT01117181|Secondary|Mini-Mental State Exam (MMSE)|Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment.|baseline and 6 weeks|||change in MMSE score||Standard Error|Mean
69333|NCT01117181|Secondary|Digit Span|Change in Digit Span at baseline and 6 weeks; this assessment is used to assess auditory attention and working memory. Higher numbers indicate better functioning.|baseline and 6 weeks||08/2013||||
69334|NCT01117181|Primary|Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change|"Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: marked worsening(7), moderate worsening (6), minimal worsening(5), no change(4), minimal improvement(3), moderate improvement(2), marked improvement(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement."|baseline to 6 weeks|||% patients moderate/marked improvement|||Number
69335|NCT01117181|Primary|Apathy Evaluation Scale (AES)|Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.|baseline to 6 weeks|||change in score on AES||Standard Error|Mean
69336|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a valsalva maneuver|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the subject was unable to perform the valsalva, or if data were missing.||mmHg||Standard Deviation|Mean
69337|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a cough|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, or if the subject was unable to cough.||mmHg||Standard Deviation|Mean
69338|NCT01117090|Secondary|The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis|Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the clamp was not open, or if the resistance check data were missing.||seconds||Standard Deviation|Mean
69339|NCT01117090|Primary|Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, CSF signatures recorded in subjects who have an infusion system who present with signs and/or symptoms of possible catheter-related problems or failure.|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, or if there was an issue with the equipment||Subjects whose CSF data agree with MD Dx|||Number
69340|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 8||Week 8|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)||ng/ml||Standard Deviation|Mean
69341|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 2||Week 2|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)||ng/ml||Standard Deviation|Mean
69342|NCT01117051|Primary|Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week|A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.|12 weeks|Intent-to-Treat (ITT) population includes all subjects who were randomized into the study and who had received at least 1 dose of investigational medication.||percentage of subjects|||Number
69343|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Weight Through Week 96|Weight is a measurement of nutritional status. Absolute change in weight, measured in kilograms (kg), at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.||kg||Standard Deviation|Mean
69344|NCT01117012|Secondary|Annualized Duration of Pulmonary Exacerbation Events||Study 105: Day 1 through Week 96|Full Analysis Set.||Days per year||Standard Deviation|Mean
69345|NCT01117012|Secondary|Annualized Pulmonary Exacerbation Event Rate|Annualized event rate was calculated by regression with negative binomial distribution.|Study 105: Day 1 through Week 96|Full Analysis Set.||events per year|||Number
69346|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.||units on a scale||Standard Deviation|Mean
69347|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in Study 105. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.||percent predicted of FEV1||Standard Deviation|Mean
69348|NCT01117012|Secondary|Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as Study 105 Day 15.|Study 105: Baseline through Week 96|Full Analysis Set.||percent predicted of FEV1 per year||95% Confidence Interval|Least Squares Mean
69349|NCT01117012|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.|Study 105: Day 1 up to Week 168|Safety Set included all participants who received at least 1 dose of study drug during Study 105.||participants|||Number
69350|NCT01116986|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.~Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome."|16 weeks post-quit|||participants|||Number
69351|NCT01116986|Secondary|Latency to Relapse|Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.|During the first 6 months post-quit|||participants|||Number
69352|NCT01116934|Primary|Serum Concentrations of Interleukin (IL)-1 Beta|Concentrations of IL-8, IL-6, IP-10, interferon (IFN)-gamma, and IL-1 beta, in plasma/RPMI samples were determined by enzyme linked immunosorbent assay (ELISA) according to the manufacturers’ instructions|2006|Samples were stimulated with 100 ng/ml lipopolysaccharide (LPS)||pg/ml||Inter-Quartile Range|Median
69353|NCT01116882|Secondary|Any Repeat Revascularization||30 days|The denominator for any repeat revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.||participants|||Number
69354|NCT01116882|Secondary|Rate of Stent Thrombosis||30 days|||participants|||Number
69358|NCT01116882|Secondary|Met Indication Criteria for PCI|Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions.|Post-Procedure|||lesions|Participants||Number
69359|NCT01116882|Secondary|Complete Revascularization|Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis.|Post-Procedure|||participants|||Number
69360|NCT01116882|Secondary|Major Vascular Complications||30 days|||participants|||Number
69361|NCT01116882|Secondary|Procedural Success|Procedural success is defined as residual stenosis of the target lesion of less than 20%|Post-Procedure|||participants|||Number
69362|NCT01116882|Secondary|Emergency or Urgent Revascularization||30 days|The denominator for emergency or urgent revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.||participants|||Number
69363|NCT01116882|Secondary|Any Repeat Revascularization||12 months|||participants|||Number
69364|NCT01116882|Secondary|Rate of Stent Thrombosis||12 months|||participants|||Number
69365|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||12 months|||participants|||Number
69366|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||30 days|||participants|||Number
69367|NCT01116882|Secondary|All Cause Mortality at 30 Days||30 days|The denominator for MACE at 30 days is defined as patients who either died to 30d or had follow up of at least 23 days.||participants|||Number
69368|NCT01116882|Primary|12-month Composite Major Adverse Cardiac Event (MACE)||12 month|||participants|||Number
69369|NCT01116882|Primary|30-day Composite Major Adverse Cardiac Event (MACE)||30 days|The denominator for MACE at 30 days is defined as patients who either had MACE to 30d or had follow up of at least 23 days.||participants|||Number
69370|NCT01116687|Secondary|Number of Related Serious Adverse Events (SAEs)|Study drug related grade 3-4 toxicities. To measure Adverse Events, investigators used the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Study duration of 12 months|All evaluable participants||events|||Number
69371|NCT01116687|Secondary|Participant Progression Free Survival (PFS) Rate|Progression-Free Survival defined as the time from start of treatment until disease progression or death as a result of any cause. Patients were re-evaluated for response every 8 weeks. Response and progression were evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.|Study duration of 12 months|All evaluable participants||months||95% Confidence Interval|Median
69372|NCT01116687|Secondary|Participant Overall Survival (OS) Rate|Overall Survival defined as the time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. The Kaplan-Meier method was used to estimate all time-to-event functions. Statistical analysis was performed using Stata SE 9.0 software and SAS 9.2 software.|Study duration of 12 months|All evaluable participants||months||95% Confidence Interval|Median
69373|NCT01116687|Primary|Number of Participants With Objective Radiographic Response (ORR)|To determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least 2 prior treatments in the metastatic setting. Radiologic assessment of tumor burden (CT scans of the chest, abdomen and pelvis, or MRI of the abdomen and pelvis and CT of the chest) was scheduled every 8 weeks. Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) were used for evaluation of the primary endpoint.|2 months from enrollment for each participant|All evaluable participants||participants|||Number
69374|NCT01116466|Secondary|Change in MRI of Affected Leg and Implant Post-implantation|MRI will be conducted to evaluate the impact of the implant on the common peroneal nerve (e.g. positioning of the nerve cuff along the nerve, path of the lead wire and the common peroneal nerve, estimation of the cross-sectional area of the common peroneal nerve compared to the pre-operative MRI recording, etc.)|Week 3 post-implantation||||||
69375|NCT01116466|Secondary|Nerve Conduction Velocity of the Peroneal Nerve|Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)|Baseline, week 12 post-implantation|Two subjects were unavailable for the test.||m/s||Standard Deviation|Mean
69376|NCT01116466|Secondary|Four Square Step Test (FSST)|It is a test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards. The patient's time to perform the test is measured which shorter time representing better performance. At baseline this test was done with subject's conventional walking aid. At 12 weeks post-implantation it was done with and without stimulation.|Baseline, week 12 post-implantation|||s||Standard Deviation|Mean
69377|NCT01116466|Secondary|Canadian Occupational Performance Measure (COPM) Score|A semi-structured interview is conducted in order to identify subject's limitations with daily occupations of importance in categories self-care, productivtiy or leisure. The subject is then asked to rate the imporance of each of the occupations using a 10-point rating scale. Afterwards the subject chooses up to 5 of the most important occupations (problems) (basis for identifying intervention goals). The subject is asked to use a 10 point scale to rate level of performance and satisfaction with performance for each of the five identified problems. Average COPM performance score and satisfaction score are calculated. The scores range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.|Baseline,12 weeks post-implantation|Two subjects were not available for the test.||units on a scale||Standard Deviation|Mean
69378|NCT01116466|Secondary|Walking Speed During 10 Meter Gait Test|The test assesses walking speed in meters per second over a short duration. At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation|||m/s||Standard Deviation|Mean
69379|NCT01116466|Primary|Distance Walked in 6 Minutes|The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation|||m||Standard Deviation|Mean
69380|NCT01116427|Secondary|Mean Change in the MSFC in Extension Phase|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from Week 24 to Week 52 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week 24 to Week 52|Intent-to-treat in Extension Phase who Completed the MSFC at Week 52||Scores on a scale||Standard Deviation|Mean
69381|NCT01116427|Secondary|Annualized Relapse in Extension Phase|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the extension and follow-up phases in each treatment group by the total number of days participants participated in the study during the extension and follow-up phases. This number is then multiplied by 365.25 to get an annualized rate.|Week 24 to Week 64|Intent-to-treat in Extension Phase||Relapse Rate by Year|||Number
69382|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Extension baseline EDSS score was the most recent non-missing value on or before Week 28. Only participants who scored between a 0 and a 5 at baseline were analyzed for this outcome measure. EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week 24 to Week 64|Intent-to-treat in Extension Phase||participants|||Number
69383|NCT01116427|Secondary|Percent Brain Volume Change Between 24 Weeks and 52 Weeks|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week 24 and a MRI scan at Week 25 then the percent change from Week 24 to Week 52 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52 with data to contribute to brain volume measurements||Percent change||Standard Deviation|Mean
69384|NCT01116427|Secondary|Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks|Difference in total volume of all T2 lesions detected at Week 52 MRI scan compared to Week 24 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52||cm^3||Standard Deviation|Mean
69385|NCT01116427|Secondary|Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase|The mean number of new inflammatory MRI lesions obtained on scans at Weeks 36 and 52, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week 24 MRI scan. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 36 and 52|Intent-to-treat in Extension Phase||New Lesions||Standard Deviation|Mean
69386|NCT01116427|Secondary|Mean Change in the MSFC Over 24 Weeks of Treatment|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from baseline to Week 24 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week -1 to Week 24|Intent-to-treat||Scores on a scale||Standard Deviation|Mean
69387|NCT01116427|Secondary|Annualized Relapse Rate|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the core phase in each treatment group by the total number of days participants participated in the study during the core phase. This number is then multiplied by 365.25 to get an annualized rate.|Week -1 to Week 24|Intent-to-treat||Relapse Rate by Year|||Number
69388|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week -1 to Week 24|Intent-to-treat||participants|||Number
69389|NCT01116427|Secondary|Mean Number of New Inflammatory Lesions in 8-week Intervals|The mean number of new inflammatory MRI lesions obtained on scans every 8 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Week 8 to Week 24|Intent-to-treat||New Lesions||Standard Deviation|Mean
69410|NCT01116024|Primary|Re-operation, Explant, Repair|"Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
69390|NCT01116427|Secondary|Percent Brain Volume Change|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week -1 and a MRI scan at Week 24 then the percent change from Week -1 to Week 24 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24 and had MRI scans at both Week -1 and Week 24||percent change||Standard Deviation|Mean
69391|NCT01116427|Secondary|Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks|Difference in total volume of all T2 lesions detected at Week 24 MRI scan compared to Week -1 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24||cm^3||Standard Deviation|Mean
69392|NCT01116427|Secondary|Absolute Number of New Inflammatory MRI Lesions on Monthly Scans|The absolute number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 4-24|Intent-to-treat||New Lesions||Standard Deviation|Mean
69393|NCT01116427|Primary|Mean Number of New Inflammatory MRI Lesions Per Monthly Scans|The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 8-24|Intent-to-treat||New Lesions||Standard Deviation|Mean
69394|NCT01116232|Secondary|Immunocorrelative Studies Pre- and Periodically Post-transplantation||Using flow cytometry at 30, 60, 90, and 180 days post transplant.||||||
69395|NCT01116232|Secondary|Overall and Disease-free Survival||At 1 year||||||
69396|NCT01116232|Secondary|Incidence of Thrombotic Microangiopathy||Within 100 days of HCT||||||
69397|NCT01116232|Secondary|Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder||At one year||||||
69398|NCT01116232|Secondary|Incidence of Chronic GVHD||Within two years after transplant||||||
69399|NCT01116232|Primary|Safety Assessment||During the first six months post transplant||||||
69400|NCT01116232|Primary|Time to Engraftment||During the first six months post transplant|Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.|||||
69401|NCT01116232|Primary|Incidence and Severity of Acute Graft-vs-host Disease (GVHD)||During the first six months post transplant|Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.|||||
69402|NCT01116102|Secondary|Technical Challenges Encountered During Fluid Infusion|Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems|at any occurence of a defined challenge or at end of infusion if no challenges occurred|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)||participants|||Number
69403|NCT01116102|Secondary|Cumulative Fluid Volume Delivered||each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per Protocol (two subjects excluded due to technical errors in fluid pressure measurement)||mL||Full Range|Mean
69404|NCT01116102|Secondary|Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement||end of catheter/needle placement|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurements)||Subjects|||Number
69405|NCT01116102|Primary|Maximum Measured In-line Fluid Pressure|Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion|each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)||psi||Full Range|Mean
69406|NCT01116024|Primary|Hemodynamics - Effective Orifice Area Index|The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.|Five Years|At discharge Effective Orifice Area index data was collected for 61 subjects.||EOAi (cm2/m2)||Standard Deviation|Mean
69407|NCT01116024|Primary|Hemodynamics - Effective Orifice Area|"Effective orifice area (EOA) data.~The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve."|Five Years|At discharge Effective Orifice Area data was collected for 61 subjects.||EOA (cm2)||Standard Deviation|Mean
69408|NCT01116024|Primary|Hemodynamic|Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.|Five Years|At discharge, gradient data was collected of 103 subjects.||mmHg||Standard Deviation|Mean
69409|NCT01116024|Primary|Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance|"New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.~Class I: Patients with cardiac disease but without limitations of ordinary activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased."|Five Years|||participants|||Number
76743|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population;||mg/dL||Full Range|Median
69411|NCT01116024|Primary|Non-Structural Dysfunction|"Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
69412|NCT01116024|Primary|Structural Valve Deterioration|"Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation.~There were no cases of structural deterioration reported for the study.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year|||Number
69413|NCT01116024|Primary|Hemolysis|Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves – as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis – is usually associated with paravalvular leakage or infection.|Five Years|||participants|||Number
69414|NCT01116024|Primary|Endocarditis|"Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
69415|NCT01116024|Primary|Paravalvular Leaks (All and Major)|"Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
69416|NCT01116024|Primary|Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)|"Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy.~Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant):~Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
69417|NCT01116024|Primary|Thromboembolism/Thrombosis|"Valve related thromboembolism and valvular thrombosis.~Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year)"|Five Years|||percentage of participants/patient-year||95% Confidence Interval|Number
69418|NCT01115998|Primary|Early Coping Inventory|We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.||Units on scale||Inter-Quartile Range|Median
69419|NCT01115998|Primary|Battelle Developmental Inventory (BDI)|Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.||Units on scale||Inter-Quartile Range|Median
69420|NCT01115998|Primary|Pediatric Evaluation of Disability Inventory|Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.||Units on scale||Inter-Quartile Range|Median
69421|NCT01115933|Secondary|Overall Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|0 - 298 days|FAS population||percentage of participants|||Number
69422|NCT01115933|Secondary|Late Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|31 - 298 days|FAS population||percentage of participants|||Number
69423|NCT01115933|Secondary|Acute/Subacute Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|0-30 days|FAS population||percentage of participants|||Number
69424|NCT01115933|Secondary|Subacute Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|1-30 days|FAS population||percentage of participants|||Number
69640|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
69425|NCT01115933|Secondary|Acute Stent Thrombosis|Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|<24 hours|FAS population||percentage of participants|||Number
69426|NCT01115933|Secondary|All Coronary Revascularization||9 months|FAS population||percentage of participants|||Number
69427|NCT01115933|Secondary|All Coronary Revascularization||1 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69428|NCT01115933|Secondary|Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|9 months|FAS population||percentage of participants|||Number
69429|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
69430|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).|1 month|FAS population||percentage of participants|||Number
69431|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69432|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
69433|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69434|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
69435|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69436|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
69437|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69438|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
69439|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS population||percentage of participants|||Number
69440|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|FAS Population||percentage of participants|||Number
69441|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS population||percentage of participants|||Number
69488|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hemoglobin measurement 72 hours after LD.||gram per deciliter (g/dL)||Standard Deviation|Mean
69442|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
69443|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69444|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
69445|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS Population||percentage of participants|||Number
69446|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|Any revascularization for in-segment restenosis will be considered TLR.“Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population||percentage of participants|||Number
69447|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69448|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|FAS Population||percentage of participants|||Number
69449|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69450|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG~Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves~Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
69451|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69452|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)||percentage of participants|||Number
69453|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|9 months|Full Analysis Set (FAS population)||percentage of participants|||Number
69454|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|"DEATH (Per ARC Circulation 2007; 115: 2344-2351)~All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac."|1 month|||percentage of participants|||Number
69455|NCT01115933|Secondary|Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.~PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)||percentage of participants||95% Confidence Interval|Number
69456|NCT01115933|Secondary|Late Loss (LL), In-segment, In-stent, Proximal and Distal|"LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up:~In-segment Late Loss: in-segment MLD post-procedure – in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure – in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure – proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure – distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)"|8 months|Full Analysis Set (FAS population)||mm||Standard Deviation|Mean
69457|NCT01115933|Secondary|Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.~PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)||percentage of DS||Standard Deviation|Mean
69458|NCT01115933|Secondary|Procedural Success(Subject Base Analysis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|ITT population||percentage of participants||95% Confidence Interval|Number
69459|NCT01115933|Secondary|Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)|Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|Intent to Treat Population (ITT)||percentage of participants||95% Confidence Interval|Number
69460|NCT01115933|Primary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)|9 Months|Full Analysis Set (FAS population)||percentage of participants|||Number
69461|NCT01115855|Secondary|Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|Specific activity scale was estimated by pre-specified questionnaire (for different activities) to assess the exercise capability of the participants. Answers provided by participants were transformed in terms of number of metabolic equivalents (METs).1 MET was defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml oxygen per kg body weight* minute. Scale ranged from 1 (less than (<) 2 METs) = lowest level of exercise tolerance to 6 (>=8METs) = highest level of tolerance and higher score indicated more tolerance.|Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||metabolic equivalents (METs)||Standard Deviation|Mean
69462|NCT01115855|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|NYHA: classified as ‘class I’ (participants with cardiac disease but without resulting limitations of physical activity), ‘class II’ (participants with cardiac disease resulting in slight limitation of physical activity), ‘class III’ (participants with cardiac disease resulting in marked limitation of physical activity), ‘class IV’ (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as ‘improved' (positive change), ‘no change’ or ‘worsened' (negative change).|Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||participants|||Number
69463|NCT01115855|Secondary|Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||microgram per gram creatinine (mg/gCr)||Standard Deviation|Mean
69464|NCT01115855|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit|LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.|Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||percentage of LVEF||Standard Deviation|Mean
69465|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||pg/mL||Standard Deviation|Mean
69466|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.||picogram/milliliter (pg/ml)||Standard Deviation|Mean
69467|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization for Hyperkalemia|Hospitalization due to hyperkalemia (as per physician’s decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69468|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function|Hospitalization due to worsening renal function (as per physician’s decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69469|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Diabetes Mellitus|New onset diabetes mellitus was defined as the diagnosis of diabetes mellitus in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69470|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter|New onset of atrial fibrillation or flutter was defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69471|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69472|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69473|NCT01115855|Secondary|Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening|Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percent or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69474|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization|CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69475|NCT01115855|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization|HF mortality was defined as any death due to HF. Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69476|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69477|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)|Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69489|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hematocrit measurement 72 hours after LD.||proportion of 1.0||Standard Deviation|Mean
69478|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69479|NCT01115855|Secondary|Number of Participants With With First Occurrence of Cardiovascular Mortality|CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69480|NCT01115855|Secondary|Number of Participants With With First Occurrence of All-Cause Mortality|All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Mortality during treatment, within 30 days of treatment discontinuation and after 30 days of discontinuation was reported. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69481|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percentage (%) or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69482|NCT01115855|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.||participants|||Number
69483|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|6 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had PRU measurements 6 hours after prasugrel LD and provided a DNA sample.||PRU||Standard Error|Least Squares Mean
69484|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|Baseline|All randomized participants who were treated with Clopidogrel and had PRU measurement at Baseline and provided a DNA sample.||PRU||Standard Error|Least Squares Mean
69485|NCT01115738|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section.|Baseline through 72 hours after prasugrel loading dose|Participants who received any treatment.||participants|||Number
69486|NCT01115738|Secondary|Percentage of Poor Responders|Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.||percentage of participants|||Number
69487|NCT01115738|Secondary|Percentage of Inhibition of Platelet Aggregation|Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant’s baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.||percentage of inhibition||Standard Error|Least Squares Mean
69490|NCT01115738|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had at least one evaluable PRU measurement after prasugrel LD.||PRU||Standard Error|Least Squares Mean
69491|NCT01115738|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|6 hours after prasugrel loading dose|All randomized participants who received the prasugrel LD and had at least one evaluable PRU measurement after LD.||PRU||Standard Error|Least Squares Mean
69492|NCT01115699|Secondary|Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)|"The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.~Screening test scoring ranges:~0-5, No Depression Likely~6-10, Possibly Mildly Depressed~11-15, Moderate Depression~16-20, Severe Depression~21 or Over, Very Severe Depression"|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.|||||
69493|NCT01115699|Primary|Change in Hamilton Rating Scale for Depression (HRS-D17)|The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.|||||
69494|NCT01115673|Secondary|Patient Global Evaluation|Patient Assessment of the Pain Medication – Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Units on a scale||Standard Error|Least Squares Mean
69495|NCT01115673|Secondary|Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score|Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Percentage of Participants|||Number
69496|NCT01115673|Secondary|Rescue Rates Through Six Hours|Percentage of subjects using rescue medication.|through 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Percentage of Participants|||Number
69497|NCT01115673|Secondary|Rescue Rates Through Four Hours|Percentage of subjects using rescue medication.|through 4 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Percentage of Participants|||Number
69498|NCT01115673|Secondary|Duration of Analgesia – Time to Rescue|Minutes until rescue medication was given.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Minutes||Full Range|Median
69499|NCT01115673|Secondary|Time to Confirmed Perceptible Pain Relief|Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Minutes||Full Range|Median
69500|NCT01115673|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||Minutes||Full Range|Median
69501|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69641|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
69502|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69503|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69504|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69505|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69506|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69507|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69508|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69509|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69510|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69511|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69512|NCT01115673|Secondary|Pain Relief (PAR) Scores at 360 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
92746|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)||Baseline up to Month 7|||percentage of participants|||Number
69513|NCT01115673|Secondary|Pain Relief (PAR) Scores at 300 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69514|NCT01115673|Secondary|Pain Relief (PAR) Scores at 240 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69515|NCT01115673|Secondary|Pain Relief (PAR) Scores at 180 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69516|NCT01115673|Secondary|Pain Relief (PAR) Scores at 120 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69517|NCT01115673|Secondary|Pain Relief (PAR) Scores at 90 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69518|NCT01115673|Secondary|Pain Relief (PAR) Scores at 75 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69519|NCT01115673|Secondary|Pain Relief (PAR) Scores at 60 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69520|NCT01115673|Secondary|Pain Relief (PAR) Scores at 45 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69521|NCT01115673|Secondary|Pain Relief (PAR) Scores at 30 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69522|NCT01115673|Secondary|Pain Relief (PAR) Scores at 15 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69523|NCT01115673|Secondary|Pain Intensity Difference (PID) at 360 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69524|NCT01115673|Secondary|Pain Intensity Difference (PID) at 300 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69642|NCT01114724|Secondary|Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment||At 12 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
69525|NCT01115673|Secondary|Pain Intensity Difference (PID) at 240 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69526|NCT01115673|Secondary|Pain Intensity Difference (PID) at 180 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69527|NCT01115673|Secondary|Pain Intensity Difference (PID) at 120 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69528|NCT01115673|Secondary|Pain Intensity Difference (PID) at 90 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69529|NCT01115673|Secondary|Pain Intensity Difference (PID) at 75 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69530|NCT01115673|Secondary|Pain Intensity Difference (PID) at 60 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69531|NCT01115673|Secondary|Pain Intensity Difference (PID) at 45 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69532|NCT01115673|Secondary|Pain Intensity Difference (PID) at 30 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69533|NCT01115673|Secondary|Pain Intensity Difference (PID) at 15 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69552|NCT01115491|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population||weeks||95% Confidence Interval|Median
69643|NCT01114724|Secondary|Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment||At 6 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
69534|NCT01115673|Secondary|Sum of Pain Relief Scores Over Six Hours (TOTPAR6)|Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69535|NCT01115673|Secondary|Sum of Pain Intensity Difference Over Six Hours (SPID6)|Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69536|NCT01115673|Primary|Overall Analgesic Efficacy – Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)|Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.||units on a scale||Standard Error|Least Squares Mean
69537|NCT01115660|Secondary|Follow up Appointment With MD|Follow up appointment with primary care provider since stroke|3 months|Patients who were contacted at 3 months||participants|||Number
69538|NCT01115660|Primary|Feasibility of Intervention (Ability to Reach Patients at 3 Months)|Number of patients contacted at 3 months|3 months|All eligible patients who also were available at 3 months for post-intervention follow-up call.||number of patients contacted|||Number
69539|NCT01115582|Secondary|Total Bilirubin|Concentration of total bilirubin in serum|At baseline and after 30 days of treatment|All patients entered and treated||mg/dL||Standard Deviation|Mean
69540|NCT01115582|Secondary|Physical Examination|Total number of patients with abnormal findings from general physical examination|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated||participants|||Number
69541|NCT01115582|Secondary|Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP)|At baseline and after 30 days of treatment|All patients entered and treated||mmHg||Standard Deviation|Mean
69542|NCT01115582|Secondary|Adverse Events|Total number of patients with any adverse events|Total of 30 days, i.e. from the time point the patients entered into the study up to the end of treatment|All patients entered and treated||participants|||Number
69543|NCT01115582|Primary|Serum and Urine Bile Acids|Concentration of bile acids in serum (S) and urine (U). (abbreviations: chol.=cholenoic; monohydro=monohydroxy; dihydro=monohydro)|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated||mmol/L||Standard Deviation|Mean
69544|NCT01115582|Primary|Serum Transaminases|Concentration of serum alanine transaminase (ALT) and aspartate transaminase (AST)|At baseline and after 30 days of treatment|All patients entered and treated||U/L||Standard Deviation|Mean
69545|NCT01115569|Secondary|Maintenance of Efficacy|Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication|1 year||||||
69546|NCT01115569|Primary|Mean Change in Average Daily Pain|Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.|1 year|The number of participants for analysis was determined by the safety population. Numeric Rating Scale (NRS) for Pain assessment was used. Measure is mean change in average daily pain intensity. Total number of participants providing end of study pain intensity score = 391.||units on a scale||Standard Deviation|Mean
69547|NCT01115517|Secondary|Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year||1 year|||participants|||Number
69548|NCT01115517|Secondary|Number of Participants Who Had Complications From the Time of Treatment to Recurrence||1 year|||participants|||Number
69549|NCT01115517|Primary|Number of Participants Who Had Recurrence of Pterygia up to 1 Year||1 year|||participants|||Number
69550|NCT01115491|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population||percentage of participants|||Number
69551|NCT01115491|Primary|PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study||BL, 24 weeks (after 6th cycle)|ITT population||survival probability|||Number
69582|NCT01114997|Secondary|Return to Normal Activities of Daily Living Using Follow up Questionnaires|Description: return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)|1 month|||participants|||Number
69553|NCT01115491|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population||percentage of participants|||Number
69554|NCT01115491|Primary|PFS - Time to Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population||weeks||95% Confidence Interval|Median
69555|NCT01115491|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.|Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population||percentage of participants|||Number
69556|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69557|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69558|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69559|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69560|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69583|NCT01114997|Secondary|Number of Participants With Postoperative Nausea One Day After Surgery|Postoperative nausea using a Verbal Rating Scale Outcomes measured at the first day after surgery|1day|||participants|||Number
69584|NCT01114997|Secondary|Opioid Consumption Obtained From the Recorded Data|Postoperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|1 day|Opioid: Hydromorphone||mg||Standard Deviation|Mean
76744|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
69561|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69562|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated.||units on a scale||95% Confidence Interval|Mean
69563|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69564|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69565|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69566|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69567|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69585|NCT01114997|Primary|Number of Participants With Post Operative Pain One Month After Surgery|"Highest Post Operative pain one month after surgery, using a verbal rating score from 0 (no pain) to 10 (highest level of pain).~Patient received a post-operative follow-up call one month after surgery."|1 month|Experience of pain at home||participants|||Number
69586|NCT01114997|Primary|Post Operative Pain|Outcome had a duration of one day at post-anesthesia care unit (PACU) Postoperative pain measured using a Verbal Rating Scale (VRS) Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.|1 day|||Score on a scale||Standard Deviation|Mean
69568|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69569|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69570|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69571|NCT01115452|Primary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated||units on a scale||95% Confidence Interval|Mean
69572|NCT01115166|Other Pre-specified|Fluid Extravasation|Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.|Two distribution half-times. Approximately 16 minutes.|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.||mL/kg/min||Standard Deviation|Median
69573|NCT01115166|Secondary|Intracellular Edema|"Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.~A positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass."|30 minutes after CPB|Mainly observational. 10 patients were regarded to be a sufficient number to se a tendency.||Litre||Standard Deviation|Mean
69574|NCT01115166|Primary|Blood Volume|"volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.~The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.~The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.~To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated."|30 minutes after start of CPB|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.||Litre||Standard Deviation|Mean
69575|NCT01115101|Secondary|Costs|Evaluation costs between groups|6 month||||||
69576|NCT01115101|Secondary|Mobilisation|Evaluation of time to post surgical mobilization|6 month||||||
69577|NCT01115101|Secondary|Side Effects|Evaluation of side effects|6 month||||||
69578|NCT01115101|Secondary|Subgroups|Secondary Outcome Measures were to identify subgroups in benefit of either therapy.|6 month||||||
69579|NCT01115101|Primary|Difference of Pain Scores on the Visual Analog Scale|"The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline.~For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain.~Single value were calculated (averaged)."|Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.|The sample size (intention to treat) was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.||VAS score at 24 hours||Standard Deviation|Mean
69580|NCT01114997|Secondary|Post-anesthesia Care Unit (PACU) Stay||1 day|||Minutes||Standard Deviation|Mean
69581|NCT01114997|Secondary|Patient Satisfaction|Patient satisfaction using a verbal rating scale from 0 to 10 0= Not satisfied 10= Excellent|1 month|||Score on a scale||Standard Deviation|Mean
69587|NCT01114945|Primary|Glottis View Using the Cormack Lehane Score|"Cormack Lehane score classification:~Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible"|Up to 1 minute|Cormack Lehane score (grade:1/2/3/4 [n])||participants|||Number
69588|NCT01114945|Primary|Percentage of Glottic Opening (POGO) [%]|"POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%.~View of the glottic opening (0-100%) during the intubation process."|up to 1 minute|||percentage of glottis opening||Standard Deviation|Mean
69589|NCT01114945|Primary|Time to Obtain Glottis Visualization (Seconds)|"It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view.~Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery"|up to 1 minute|||Seconds||Standard Deviation|Mean
69590|NCT01114945|Primary|Intubation Time Using a Stop Watch|Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.|up to 3 minutes|"Times following initial insertion of laryngoscope blade:~to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec)"||Seconds||Standard Deviation|Mean
69591|NCT01114893|Secondary|IOP Change From Baseline at 8 PM on Day 5|Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment|5 Days|||mm Hg||95% Confidence Interval|Mean
69592|NCT01114893|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5|Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment|5 days|||mm Hg||95% Confidence Interval|Mean
69593|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 24|ITT analysis set, observed cases||units on a scale||Standard Deviation|Mean
69594|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 12|ITT analysis set, observed cases||units on a scale||Standard Deviation|Mean
69595|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 24|ITT analysis set, LOCF||milligrams/liter||Standard Deviation|Mean
69596|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 12|ITT analysis set, LOCF||milligrams/liter||Standard Deviation|Mean
69597|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
69598|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
69599|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 24|ITT analysis set, LOCF||centimeters||Standard Deviation|Mean
69600|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 12|ITT analysis set, LOCF||centimeters||Standard Deviation|Mean
69636|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn or were lost to follow-up before the lower limit of the 12 mos follow-up window.One subject was lost to follow-up and one withdrew before 12 mos. One of these subjects experienced an AE before study exit and was included in the analysis,||participants|||Number
69601|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 24|ITT analysis set, LOCF||units on a scale||Standard Deviation|Mean
69602|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 12|ITT analysis set, LOCF||units on a scale||Standard Deviation|Mean
69603|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 24|ITT analysis set, LOCF||millimeters||Standard Deviation|Mean
69604|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 12|ITT analysis set, LOCF||millimeters||Standard Deviation|Mean
69605|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 24|ITT analysis set, missing data imputed by last observation carried forward (LOCF)||millimeters||Standard Deviation|Mean
69606|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 12|ITT analysis set, missing data imputed by last observation carried forward (LOCF)||millimeters||Standard Deviation|Mean
69607|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
69608|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
69609|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
69610|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
69611|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
69612|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 12|ITT analysis set, missing data imputed by NRI||participants|||Number
69613|NCT01114880|Secondary|Number of Participants Meeting the ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI||participants|||Number
69637|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 30 days|Based on number of ITT subjects with available data.||participants|||Number
69614|NCT01114880|Primary|Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response.||participants|||Number
69615|NCT01114828|Secondary|Ascites Volume as Measured by CT|Change from baseline (day-1) for ascites volume as measured by CT at the end of treatment (LOCF) were calculated.|Baseline, Day 7 or at the discontinued of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.||mL||Standard Deviation|Mean
69616|NCT01114828|Primary|Body Weight|Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.|Bseline, Day 7 or at the discontined of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.||kg||Standard Deviation|Mean
69617|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26|||T score||95% Confidence Interval|Least Squares Mean
69618|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26|||T score||95% Confidence Interval|Least Squares Mean
69619|NCT01114737|Primary|Number of Participants With a Score of 1 or 2 in Global Function Evaluation (CGI-I) From Baseline to Week 13.|"Effects of 6R-BH4 on global function in PKU subjects in subjects that had a blood Phe level reduction after treatment with 6R-BH4 at screening.~The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse."|13 weeks|Missing data for 1 subject in the Responders in 6R-BH4 20 mg/kg/day Arm||Number of participants with scale 1 or 2|||Number
69620|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Mean
69621|NCT01114737|Secondary|Change in Hamilton Rating Scale For Depression (HAM-D) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Least Squares Mean
69622|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Least Squares Mean
69623|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 26|||units on a scale||95% Confidence Interval|Least Squares Mean
69624|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is <18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
69638|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.||participants|||Number
69625|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is >=18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
69626|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Week 13 to Week 26|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
69627|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Week 13 to Week 26|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
69628|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Week 13 to Week 26|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
69629|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Week 13 to Week 26|Phe Responders with ADHD Symptoms||units on a scale||95% Confidence Interval|Least Squares Mean
69630|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are <18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
69631|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are >=18 Years of Age||T score||95% Confidence Interval|Least Squares Mean
69632|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 13|"Effects of 6R-BH4 on global function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 13|Phe Responders||units on a scale||95% Confidence Interval|Least Squares Mean
69633|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of depression in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 13|||units on a scale||95% Confidence Interval|Least Squares Mean
69634|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of anxiety in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 13|||units on a scale||95% Confidence Interval|Least Squares Mean
69635|NCT01114737|Primary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of ADHD in PKU subjects who had symptoms of ADHD at screening in the subjects that had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 13|||units on a scale||95% Confidence Interval|Least Squares Mean
69644|NCT01114724|Secondary|Subjects With Secondary Endovascular Procedures||Through12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)||participants|||Number
69645|NCT01114724|Secondary|Aortic Rupture||Within 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)||participants|||Number
69646|NCT01114724|Secondary|Aortic Rupture||Within 30 days|Based on number of ITT subjects with available data.||participants|||Number
69647|NCT01114724|Secondary|Subjects With Coverage of Primary Tear||At implant|Based on number of ITT subjects with available data||participants|||Number
69648|NCT01114724|Secondary|Subjects With Successful Delivery and Deployment of the Device.||At implant.|Based on number of ITT subjects with available data||participants|||Number
69649|NCT01114724|Secondary|All-cause Mortality||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)||participants|||Number
69650|NCT01114724|Primary|All Cause Mortality.||Up to 30 days after the stent graft implant.|Based on number of ITT subjects with available data||participants|||Number
69651|NCT01114672|Primary|Severity of Pruritis|"Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis.~Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis."|Baseline and end of study (up to 12 weeks)|Number randomized in each arm 25||units on a scale||Standard Deviation|Mean
69652|NCT01114581|Secondary|Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.||Within 10 days of developing symptoms associated with a respiratory tract infection||||||
69653|NCT01114581|Secondary|Guaifenesin AUC(0-3)||3 hours following dose administration|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
69654|NCT01114581|Primary|Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs|Percentage of inhaled radioactive tracer (Ave180Clear)|3 hours following inhalation of radioactive tracer particles|Intent to treat||Percentage of inhaled radioactive tracer||Standard Deviation|Mean
69655|NCT01114516|Secondary|Birthweight|Median birthweight|24 weeks|||grams||Inter-Quartile Range|Median
69656|NCT01114516|Secondary|Neonatal Morbidity and Mortality|Days spent in the neonatal intensive care unit|1 year|||days||Inter-Quartile Range|Median
69657|NCT01114516|Secondary|Gestational Age at Delivery|Median gestational age at delivery|24 weeks|||weeks||Inter-Quartile Range|Median
69658|NCT01114516|Secondary|Gestational Latency of More Than 28 Days|The frequency of achieving a gestational latency of more than 28 days|28 days postpartum|||percentage of participants|||Number
69659|NCT01114516|Primary|Gestational Latency Achieved Between Cerclage Placement and Time of Delivery|Median gestational latency achieved Between Cerclage Placement and Time of Delivery|24 weeks|||days||Inter-Quartile Range|Median
69660|NCT01114373|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||minutes||Standard Error|Mean
69661|NCT01114373|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
69662|NCT01114373|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
69663|NCT01114373|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
69664|NCT01114373|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
69665|NCT01114373|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
69666|NCT01114373|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
69696|NCT01113749|Primary|Decisional Conflict Scale|Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.|3 months|intention to treat||units on a scale||95% Confidence Interval|Mean
92747|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)||Baseline up to Month 7|||percentage of participants|||Number
69667|NCT01114373|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69668|NCT01114373|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69669|NCT01114373|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69670|NCT01114373|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
69671|NCT01114373|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69672|NCT01114373|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69673|NCT01114373|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69674|NCT01114360|Secondary|Percentage of Participants With Melatonin-related Side Effect.||After 4 weeks of treatment|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||percentage of total number of patients|||Number
69675|NCT01114360|Secondary|Nocturnal Dipping of Blood Pressure|Nocturnal dipping is the mean nighttime to mean daytime systolic and diastolic blood pressure ratios, or the percentage drop in nocturnal SBP compared to day time SBP. Night was defined as 10:00 PM through 5:59 AM. This ratio is calculated by the ambulatory blood pressure readings.|At the end of 4 weeks|||percentage ratio in night/day SBP||Standard Error|Mean
69676|NCT01114360|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||minutes||Standard Error|Mean
69677|NCT01114360|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
69678|NCT01114360|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml||Standard Error|Mean
69679|NCT01114360|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|40 patients were enrolled in the study. 4 subjects did not complete the study. 36 patients completed the study and were their own controls.||ng/ml/min||Standard Error|Mean
69680|NCT01114360|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
69681|NCT01114360|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||ng/ml/min||Standard Error|Mean
69697|NCT01113723|Primary|Time to Confirm the Placement of the Tracheal Tube|It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform|up tp 3 minutes|||Seconds||Standard Deviation|Mean
69698|NCT01113723|Primary|Intubation Time (Seconds)|Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube|3 minutes|||Seconds||Standard Deviation|Mean
69682|NCT01114360|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69683|NCT01114360|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of the pulsations of the heart per unit of time during the day. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
69684|NCT01114360|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported.|At the end of 4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69685|NCT01114360|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69686|NCT01114360|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69687|NCT01114360|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is number of pulsations of the heart per unit of time during nighttime sleep. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||beats per minute||Standard Error|Mean
69688|NCT01114360|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69689|NCT01114360|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.||mmHg||Standard Error|Mean
69690|NCT01113931|Secondary|Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured|Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28|Day 28|N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.||Percentage Participants Cured||95% Confidence Interval|Number
69691|NCT01113931|Secondary|Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured|Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28|End of Study (Day 28)|M. genitalium Coinfected Population||Percentage Participants Cured|||Number
69692|NCT01113931|Secondary|Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured|Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28|End of Study (Day 28)|Clinically Evaluable Population||Percentage Particpants Cured|||Number
69693|NCT01113931|Primary|Microbiological Cure Rate|Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28|Day 28|mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.||percentage of participants cured||95% Confidence Interval|Number
69694|NCT01113749|Post-Hoc|Percentage of Subjects With Weight Loss|Percentage of subjects with weight loss at 9 months|9 months|intention to treat||percentage of participants|||Number
69695|NCT01113749|Secondary|Percent With Treatment Decisions|Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding.|3 months|||percentage of subjects|||Number
69699|NCT01113723|Secondary|Time to Obtain Glottis Visualization (Seconds)|Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine.|1 minute|Time to Obtain Glottis Visualization (Seconds) Glottic visualization during the beginning of the intubation procedure.||Seconds||Standard Deviation|Mean
69700|NCT01113710|Secondary|Daytime Tiredness|"Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 561 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
69701|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime in Activity|"Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
69702|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime at Rest|"Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 562 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
69703|NCT01113710|Secondary|Satisfaction With Sleep|"Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
69704|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) During the Night|"Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
69705|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) at Bedtime|"Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."||units on a scale||Standard Deviation|Mean
69706|NCT01113632|Secondary|Safety of the Treatment Regimen|Listing of all non-serious Adverse Events ocurring in 5% of patients or more|18 Months|||participants|||Number
69707|NCT01113632|Secondary|Number of Partial Responses|The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|18 Months|All patients who were evaluable for a response assessment||participants|||Number
71191|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
69708|NCT01113632|Secondary|Number of Complete Responses|The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions|18 Months|All patients who were evaluable for a response assessment||participants|||Number
69709|NCT01113632|Primary|Overall Response Rate (ORR)|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients who were evaluable for a response assessment||participants|||Number
69710|NCT01113632|Secondary|Progression-free Survival (PFS)|To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.|18 months|||months||95% Confidence Interval|Median
69711|NCT01113580|Secondary|Frequency and Intensity of Any Unsolicited Adverse Events|"Unsolicited adverse event (UAE) grading:~Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.||participants|||Number
69712|NCT01113580|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The number of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.||participants|||Number
69713|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||Percentage of participants||95% Confidence Interval|Number
69714|NCT01113580|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||Fold increase||95% Confidence Interval|Number
69715|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||Percentage of participants||95% Confidence Interval|Number
69716|NCT01113541|Secondary|Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline, Week 1 through Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||participants|||Number
69717|NCT01113541|Secondary|Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale|31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
69718|NCT01113541|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on scale||95% Confidence Interval|Mean
69719|NCT01113541|Secondary|Change From Baseline in EuroQoL Index (EQ-I)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on scale||95% Confidence Interval|Mean
92748|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)||Baseline up to Month 7|||percentage of participants|||Number
69720|NCT01113541|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)|0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on scale||Standard Deviation|Mean
69721|NCT01113541|Secondary|Change From Baseline in Drug Attitude Inventory (DAI)|DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
69722|NCT01113541|Secondary|Clinical Global Impression - Improvement (CGI-I) Subscale Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
69723|NCT01113541|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
69724|NCT01113541|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS)|11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale|||Number
69725|NCT01113541|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
69726|NCT01113541|Secondary|Change From Baseline in Physical Activity Index|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||units on a scale|||Number
69727|NCT01113541|Secondary|Change From Baseline in Leptin||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||nanograms per milliliter||Standard Deviation|Mean
69728|NCT01113541|Secondary|Change From Baseline in Apolipoprotein B (ApoB) Levels||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||milligrams per deciliter||Standard Deviation|Mean
69729|NCT01113541|Secondary|Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.|Baseline, Week 4, Week 52 or Early Termination|PP and ITT; n = number of participants with analyzable data at observation.||milliseconds||Standard Deviation|Mean
69730|NCT01113541|Secondary|Change From Baseline in Insulin Levels||Baseline, Week 52 or Early Termination|PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study.||international units per milliliter||Full Range|Median
69731|NCT01113541|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag.||percent HbA1c||Full Range|Median
69732|NCT01113541|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index = weight in kilograms (kg) / height in meters (m)^2 .|Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study.||kg/m^2||Standard Deviation|Mean
69733|NCT01113541|Secondary|Change From Baseline in Weight||Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT; n = number of participants with evaluable data at observation.||kilograms||Standard Deviation|Mean
69734|NCT01113541|Secondary|Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing.||milligrams per deciliter||Full Range|Median
69771|NCT01112670|Other Pre-specified|Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng*h/ml||Standard Deviation|Mean
69735|NCT01113541|Secondary|Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).|Baseline, Week 4, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||scores on a scale||Standard Deviation|Mean
69736|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides|MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimoles per liter||Standard Deviation|Mean
69737|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)|MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimoles per liter||Standard Deviation|Mean
69738|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose|MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimoles per liter||Standard Deviation|Mean
69739|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure|MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||millimeters of mercury||Standard Deviation|Mean
69740|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference|MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||centimeters||Standard Deviation|Mean
69741|NCT01113541|Secondary|Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors|MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||percentage of participants|||Number
69742|NCT01113541|Secondary|Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||percentage of participants|||Number
69743|NCT01113541|Secondary|Metabolic Syndrome (MS) Prevalence|Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.||percentage of participants|||Number
69744|NCT01113541|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 52|PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study.||risk factors||Standard Deviation|Mean
69745|NCT01113541|Primary|Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation|MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.|Week 52 or Early Termination|Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation.||percentage of participants|||Number
69761|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS||percentage of dyads, adult participants||95% Confidence Interval|Number
69746|NCT01113463|Secondary|Number of Participants by Response Criteria|Complete Response (CR): Complete disappearance all measurable & evaluable disease. No new lesions or evidence of non-evaluable disease. Partial Response (PR): >/= 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, nor new lesions. Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 12 weeks duration. Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Unknown: Progression not been documented & one or more measurable or evaluable sites have not been assessed.|Response obtained between days 15 and 21 of every even cycle and/or when clinically indicated, up to 6 months (approximately 9 completed cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.||participants|||Number
69747|NCT01113463|Primary|Progression-Free Survival (PFS) at 6 Months|"PFS defined as number of participants alive without documented evidence of disease progression (progression free) at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|6 months (following nine 21-day cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.||participants|||Number
69748|NCT01113398|Secondary|Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities|The percentage of participants who experience unacceptable toxicity, defined as any treatment-related grade 2 or greater CNS hemorrhage or grade 4 or greater non-hematologic toxicity, will be calculated.|2 years|Intent-to-treat||percentage of participants|||Number
69749|NCT01113398|Secondary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
69750|NCT01113398|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|2 years|Intent-to-treat||Months||95% Confidence Interval|Median
69751|NCT01113398|Primary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.|2 years|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
69752|NCT01113385|Secondary|Number of Participants Achieving Complete or Partial Remission at 16 Weeks|Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16. Complete remission is defined as (Urine Protein:Creatinine ratio [UPC] <0.2 g/g). Partial remission is defined as UPC 0.2-2 g/g.|16 weeks|||participants in remission at 16 weeks|||Number
69753|NCT01113385|Primary|Focal Segmental Glomerulosclerosis Permeability Factor (FSPF)|FSPF is reported in relation to its induction of glomerular albumin permeability (Palb) of isolated glomeruli on a range from 0 to 1, with 0 indicative of normal glomeruli and 1 indicative of injury to the permeability barrier. Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16: Reduction in FSPF to <0.5 Palb or decrease in FSPF by > 0.3 Palb.|16 weeks|||Palb||Standard Deviation|Mean
69754|NCT01113008|Secondary|Cardiovascular Mortality||12 month|||participants|||Number
69755|NCT01113008|Secondary|Readmission Due to Acute Coronary Syndrome||12 month|||participants|||Number
69756|NCT01113008|Primary|Maximum Increase of Troponin at 24 Hours||24 hours|||ng/ml||95% Confidence Interval|Mean
69757|NCT01112917|Secondary|Major Device-Related Adverse Events in Converted Subjects||6-months|There was one subject (007-006) excluded as no 6-month images were available although a 6-month assessment was conducted.||participants|||Number
69758|NCT01112917|Primary|Technical Success|Technical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs. Further, in the analysis of the data, the sponsor did not count any filters as a ‘technically’ successful conversion when the operator was unable to snare the filter hook during an attempted conversion.|6-months|||participants|||Number
69759|NCT01112865|Secondary|Ease of Use of Each Injection Pen|Participants were asked the following question from Section I of the IPAQ PRO tool, “Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?” Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1).|Month 2 and Month 4|FAS; Number of participants analyzed (N) = participants with evaluable data||scores on a scale||Standard Deviation|Mean
69760|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen|"Investigators were asked the following study treatment continuation question, Which device did the participant choose for continued treatment? Choices included the Genotropin® Pen or the new injection pen."|Month 4|FAS subset of participants located in areas where the new device was available.||percentage of dyads, adult participants||95% Confidence Interval|Number
69762|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|FAS; Number of participants analyzed (N)= participants with evaluable data||percentage of dyads, adult participants||95% Confidence Interval|Number
69763|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS||percentage of dyads, adult participants||95% Confidence Interval|Number
69764|NCT01112865|Primary|Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|Full Analysis Set (FAS): randomized participants who used a study pen at least once to administer somatropin; Number of participants analyzed (N)= participants with evaluable data. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).||percentage of dyads, adult participants||95% Confidence Interval|Number
69765|NCT01112696|Secondary|Device Related Moderate or Device Related Severe Adverse Events|"Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy.~Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment.~Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device."|days one through six of sensor wear||||||
69766|NCT01112696|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|98 subjects of 100 enrolled subjects (a total of 5857 paired sensor and YSI readings) completed participation in the inpatient frequent blood sampling procedure.||paired sensor and YSI glucose readings|Participants|95% Confidence Interval|Number
69767|NCT01112683|Secondary|Changes of Safety and Tolerability Assessments at Baseline and End of Study|Clinical history and physical examinations, electrocardiograms (ECGs), comprehensive clinical laboratory tests, and incidence of adverse event recording. The comprehensive clinical laboratory tests will include assessments of liver and kidney function, electrolytes, acid/base balance, and blood glucose and proteins. In addition, pregnancy tests will be performed on all female participants of childbearing potential.|Safety and tolerability assessments will be performed at three time points: 1) 1-7 days before beginning of treatment; 2) after 8 weeks from the beginning of the treatment; and 3) 16-17 weeks from the beginning of the treatment|||participants|||Number
69768|NCT01112683|Secondary|Changes in Benchmark Neuropsychological Measures From Baseline to End of Study|"The neuropsychological benchmark measures assessed in this study are~Peabody Picture Vocabulary Test-III (PPVT-III; range: -27.00 to 23.00)~Test for the Reception of Grammar (TROG; range: -13.00 to 19.00)~Verbal Fluency (from the Developmental Neuropsychological Assessment (NEPSY); range: -13.00 to 10.00)~Recall of Digits (Differential Ability Scales; DAS; -50.00 to 59.00)~Spatial working memory (SWM; part of the Cambridge Neuropsychological Test Automated Battery, or CANTAB; range: -9.00 to 8.00)~Scales of Independent Behavior Revised (SIB-R; -12.00 to 26.00) All listed values represent differences in scores obtained at baseline subtracted from scores at 16-weeks of treatment. With the exception of the spatial working memory, for all measures, higher values represent better outcome. For the spatial working memory, lower values represent better outcome."|Benchmark neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|These measures were not predicted to change due to memantine treatment. Measures of non-verbal reasoning, receptive language and vocabulary, short-term phonological memory, verbal and non-verbal working memory and adaptive/behavioral functioning were included.||scores on a scale||90% Confidence Interval|Mean
69769|NCT01112683|Primary|Changes in Neuropsychological Measures From Baseline to End of Study|"The hippocampus-dependent measures assessed in the present study are~Pattern recognition memory* - Measures visual memory for non-namable designs; scale range in dataset 4-24; higher score indicates better performance~Paired associates task* - Measures ability to learn visual associations between a picture and its location, and retention of this information over time; scale range in dataset 0-17; higher score indicates better performance~California Verbal Learning Test (CVLT) — Children's Version** - Measures episodic verbal memory (sum of the items recalled over the 4 learning trials); scale range in dataset 0-35; higher score indicates better performance~Rivermead Behavioral Memory Test-Children's version** - Measures episodic memory for visual information presented in context; scale range in dataset 1-20; higher score indicates better performance * used in power analysis calculation of sample size ** secondary measures associated with the primary hypothesis"|These neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|One participant dropped out of the study due to parent complaints of increased anxiety, and another was excluded from analyses due to side effects (increased and persistent anxiety) reported at study completion.||units on a scale||90% Confidence Interval|Mean
69770|NCT01112670|Other Pre-specified|Atorvastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng/ml||Standard Deviation|Mean
69772|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Renal Clearance (CLr)|CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.||ratio||95% Confidence Interval|Mean
69773|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.||ml/min||Standard Deviation|Mean
69774|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.||ml/min||Standard Deviation|Mean
69775|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax)|Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ratio||95% Confidence Interval|Mean
69776|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity|AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ratio||95% Confidence Interval|Mean
69777|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng/ml||Standard Deviation|Mean
69778|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng*h/ml||Standard Deviation|Mean
69779|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng/ml||Standard Deviation|Mean
69780|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.||ng*hr/ml||Standard Deviation|Mean
69781|NCT01112579|Secondary|Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months|||mL/kg/min||Standard Deviation|Mean
69782|NCT01112579|Secondary|Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months|||pg/mL||Standard Deviation|Mean
69783|NCT01112579|Primary|Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.||Baseline and 6 months|||mL/m2||Standard Deviation|Mean
69784|NCT01112514|Primary|Number of Neoplastic Lesions Detected||upto 15 mins|||Lesions|||Number
69785|NCT01112267|Secondary|Percentage of Participants With Participants' Global Assessment on Investigational Product|"Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
69786|NCT01112267|Secondary|Percentage of Participants With Investigator's Global Assessment on Investigational Product|"Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
69787|NCT01112267|Secondary|Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29|The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.|Baseline and Day 29|FAS population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Unit on a scale||Standard Deviation|Mean
69788|NCT01112267|Secondary|Change From Baseline in Short Form (SF)-36 Score at Day 29|"The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in Reported (Rptd.) Health Transition domain higher score indicates worse quality of life."|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Unit on a scale||Standard Deviation|Mean
69789|NCT01112267|Secondary|Percentage of Participants With Pain Relief|Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.|Day 8, Day 15 and Day 29|the FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Percentage of participants||95% Confidence Interval|Number
69790|NCT01112267|Primary|Change From Baseline in Pain Intensity at Day 29|Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Unit on a scale||Standard Deviation|Mean
69791|NCT01112267|Primary|Percentage of Participants With Reduction in Pain Intensity|The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline up to Day 29|Full analysis set (FAS) population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.||Percentage of Participants||95% Confidence Interval|Number
69792|NCT01112241|Primary|Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC (L), before bronchodilators - FRC (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute negative change (liters)||Standard Deviation|Mean
69793|NCT01112241|Primary|Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC, expressed in liters (L), before bronchodilators - FRC (L) after bronchodilators/FRC (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent negative change||Standard Deviation|Mean
69794|NCT01112241|Primary|Absolute Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV (L), before bronchodilators - RV (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute negative change (liters)||Standard Deviation|Mean
69795|NCT01112241|Primary|Per Cent Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV, expressed in liters (L), before bronchodilators - RV (L) after bronchodilators/RV (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent negative change||Standard Deviation|Mean
69796|NCT01112241|Primary|Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'part increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'part, expressed in liters.second-1 (L.s-1), after bronchodilators - V'part (L.s-1) before bronchodilators/V'part (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
69797|NCT01112241|Primary|Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'max increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'max, expressed in liters.second-1 (L.s-1), after bronchodilators - V'max (L.s-1) before bronchodilators/V'max (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following HSCT for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
70801|NCT01100437|Other Pre-specified|Naltrexone Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13||picogram/milliliter (pg/mL)||Standard Deviation|Mean
69798|NCT01112241|Primary|Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥0.20 liters (L) compared with baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC (L) after bronchodilators - FVC (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute positive change (liters)||Standard Deviation|Mean
69799|NCT01112241|Primary|Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC, expressed in liters (L), after bronchodilators - FVC (L) before bronchodilators/FVC (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
69800|NCT01112241|Primary|Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥0.20 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1 (L) after bronchodilators - FEV1 (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||absolute positive change (liters)||Standard Deviation|Mean
69801|NCT01112241|Primary|Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1, expressed in liters (L), after bronchodilators - FEV1 (L) before bronchodilators/FEV1 (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).||per cent positive change||Standard Deviation|Mean
69802|NCT01111851|Secondary|Brain NK1-receptor Occupancy at 120 Hours Post Dose||120 hours post dose|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
69803|NCT01111851|Secondary|Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)||30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
69804|NCT01111851|Primary|Brain NK1-receptor Occupancy at 48 Hours Post Dose||48 hours post dose|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
69805|NCT01111851|Primary|Brain NK1-receptor Occupancy at 24 Hours Post Dose||24 hours post dose|"All participants with at least 1 successful post dose PET~scan were included in the analysis population."||Percent of occupancy||95% Confidence Interval|Geometric Mean
69806|NCT01111838|Primary|To Determine Overall Objective Response.|Patients with measurable disease will be evaluated using RECIST criteria for determination of response.|every 8 weeks|||participants|||Number
69807|NCT01111526|Secondary|Occurrence of Possibly Related Adverse Events|Number of participants with adverse events possibly related to study treatment, per event category.|5 years, 3 months|All participants||participants|||Number
69808|NCT01111526|Secondary|Stable or Improved Chronic GVHD Severity Score|Stable or improved Chronic GVHD score: Improved Mild to None; Improved Severe to Moderate; Improved Moderate to None, Remained Stable at Mild.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at 1 year.||participants|||Number
69809|NCT01111526|Secondary|Chronic GVHD Severity at MTD|Chronic GVHD maximum severity grade at MTD, in participants without overlap syndrome at initiation of study therapy. Maximum c-GVHD severity: Mild, Moderate, Severe.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at time of analysis.||participants|||Number
69810|NCT01111526|Secondary|Chronic GVHD Onset|Chronic GVHD onset in participants without overlap syndrome at initiation of study therapy. Number of participants with overlap syndrome at MTD.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.||participants|||Number
69811|NCT01111526|Secondary|Occurrence of Discontinuation of All Immune Suppression|Number of participants discontinuing all immune suppression without subsequent flare by 1 year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks and were evaluable at 365 days.||participants|||Number
69812|NCT01111526|Secondary|Overall Survival (OS)|Overall Survival (OS) at one year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.||participants|||Number
92749|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)||Baseline up to Month 7|||percentage of participants|||Number
69813|NCT01111526|Secondary|Incidence of GVHD Flares Requiring Increasing Immune Suppressive Therapy|Number of participants with GVHD flares requiring increasing immune suppressive therapy within 36 days of study initiation. Cumulative incidence of GVHD flares requiring increasing immune suppressive therapy will be analyzed using the competing risk method by Gray (1988). GVHD flares (progressive disease (PD)) may result in discontinuation from Panobinostat.|Up to 36 days per participant|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.||participants|||Number
69814|NCT01111526|Primary|Phase II: Overall Rate of Response (ORR)|Rate of Complete Response (CR), Partial Response (PR), Progressive Disease (PD) and Stable Disease (SD). Assessment of GVHD will include the skin, liver and gut. Other possible etiologies of organ disease such as C difficile enterocolitis, viral infection, drug reaction, veno-occlusive disease of the liver, etc., will be excluded by appropriate tests. CR is defined as resolution of GVHD in all evaluable organs with no subsequent additional treatment given for acute GVHD. PR is defined as improvement in ≥ one evaluable organ without deterioration in at least one other. PD is defined as deterioration in at least on evaluable organ. SD is defined as the absence of any difference sufficient to meet minimal criteria for improvement or deterioration in any evaluable organs.|1 year, 2 months|All participants treated at maximum tolerated dose (MTD) of Oral Formulation LBH589, and evaluable at planned time of analysis.||participants|||Number
69815|NCT01111526|Primary|Phase I: Maximum Tolerated Dose (MTD) in Milligrams|MTD of LBH589 in addition to glucocorticoids as treatment for Graft Versus Host Disease (GVHD) manifestations. MTD in Milligrams (mg), taken by mouth (PO), 3 times per week, for 4 weeks. The oral formulation replaced the IV formulation (which became unavailable) after the first 4 participants were treated. Dose limiting toxicity (DLT) is defined by the occurrence of Common Toxicity Criteria (CTC) grade 3 or greater toxicity that is unexpected with transplantation, except for hematological toxicity, where DLT is defined as absolute neutrophil count (ANC) <750, and for those participants who were platelet transfusion independent is defined as platelets <10 K.|2 years, 8 months|All participants treated with Oral Formulation LBH589, during Phase I Dose Escalation.||MTD of oral LBH589 in milligrams|||Number
69816|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Apparent Diffusion Coefficient (ADC) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in ADC for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 2 participants with evaluable data.||Percentage change||Standard Deviation|Mean
69817|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Contrast Volume Transfer Coefficient (Ktrans) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in Ktrans for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.||Percentage change||Standard Deviation|Mean
69818|NCT01111461|Other Pre-specified|Percentage Change From Baseline for the Imaging Biomarker Parameter of the Area Under the Plasma Concentration Curve Blood Normalized (90) (AUCBN (90)) Median for Total Volume|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of 2 dynamic contrast-enhanced magnetic resonance imaging/diffusion-weighted magnetic resonance imaging (DCE-MRI/DWI MRI) scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included percentage change in initial area under the gadolinium contrast agent time-concentration curve (first 90 seconds, blood normalized) from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.||Percentage change||Standard Deviation|Mean
69819|NCT01111461|Other Pre-specified|Summary of Plasma Concentration of Lenvatinib|A total of 6 blood samples for pharmacokinetic (PK) analysis were collected from each participant who received lenvatinib once daily.|Predose and 2 hours postdose on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 2 Day 1|PK analysis set was used and included all participants with an evaluable plasma concentration.||ng/mL||Standard Deviation|Mean
69820|NCT01111461|Secondary|Number of Participants With Adverse Events (AEs) /Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs and SAEs, regular monitoring of hematology, clinical chemistry, and urine values, regular measurement of vital signs, electrocardiograms (ECGs), and echocardiograms.|From the administration of first dose up to 30 days after the last dose, or up to data cut-off (21 May 2012), or up to approximately 26 months.|Safety Analysis Set included all participants who received at least 1 dose of lenvatinib and had at least 1 postbaseline safety evaluation. This was the analysis set for all safety evaluations.||Participants|||Number
69821|NCT01111461|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) [CR + PR + dSD] based on RECIST 1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 23 weeks), as determined by the IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Percentage of participants||95% Confidence Interval|Number
77016|NCT01032382|Secondary|Detectable Paromomycin Plasma Levels|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4, 7, 12, 17, 20, 28|Adults (18+ years)||ng/mL||Standard Deviation|Mean
69822|NCT01111461|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with BOR of CR or PR or stable disease (SD) based on RECIST 1.1 and SD lasting greater than or equal to 7 weeks, as determined by IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Percentage of participants||95% Confidence Interval|Number
69823|NCT01111461|Secondary|Overall Survival (OS)|OS was the length time in months from the date of first treatment until the date of death from any cause. If death was not observed, OS was censored at the last known alive date or data cut-off. Additional survival follow-up data was collected for all participants who had not withdrawn consent and were alive at the time of the initial survival follow-up as of 26 Nov 2012 data cut-off. Participants who were lost to follow-up at the time of the initial assessment may have been contacted again at the investigator's discretion. Updated survival (based on 26 Nov 2012 cut-off) was derived for these participants if the contact was made successfully.|From date of first administration of study treatment until the date of death, or up to approximately 32 months (as of 26 Nov 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Months||95% Confidence Interval|Median
69824|NCT01111461|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death (whichever occurred first), as determined by independent radiologic review (IRR) and Investigator based on RECIST 1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.||Months||95% Confidence Interval|Median
69825|NCT01111461|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was ≤10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR|From the date of first administration of study treatment until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to the end of Cycle 6 (as of 21 May 2012 data cut-off)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) was used and included all participants who received at least 1 dose lenvatinib.||Percentage of participants||95% Confidence Interval|Number
69826|NCT01111331|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|Drug administration until beginning of next sequence/end of trial, 35 days|Treated set (TS) included all subjects who had taken at least one dose of trial medication.||participants|||Number
69827|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (PT AUEC0-tz,Base)|Area under the PT-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the PT-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s*hr||95% Confidence Interval|Geometric Mean
69828|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time Adjusted to Baseline (PTmax,Base)|Peak prothrombin time adjusted for baseline value (before any trial drug administration) of peak prothrombin|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s||95% Confidence Interval|Geometric Mean
69829|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point (PT AUEC0-tz)|Area under the PT-time curve from time of dosing to time of last measurable data point|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s*hr||95% Confidence Interval|Geometric Mean
69830|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (INR AUEC0-tz,Base)|Area under the INR-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the INR-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||ratio*h||95% Confidence Interval|Geometric Mean
69831|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time (PTmax)|Peak prothrombin time|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||s||95% Confidence Interval|Geometric Mean
69832|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio Adjusted to Baseline (INRmax,Base)|Peak international normalised ratio for warfarin adjusted for baseline value (before any trial drug administration) of peak international normalised ratio|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||Ratio||95% Confidence Interval|Geometric Mean
69833|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point (INR AUEC0-tz)|Area under the concentration time curve of the INR measurements over the time interval from 0 to the time of the last quantifiable data point.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||ratio*h||95% Confidence Interval|Geometric Mean
69834|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio (INRmax)|Peak international normalised ratio for warfarin, measured as the maximum INR over time.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.||Ratio||95% Confidence Interval|Geometric Mean
69835|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
69836|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
69837|NCT01111331|Secondary|Warfarin S-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
69838|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
69839|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
69840|NCT01111331|Secondary|Warfarin S-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
69841|NCT01111331|Secondary|Warfarin S-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
70802|NCT01100437|Other Pre-specified|Morphine Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13||ng/mL||Standard Deviation|Mean
69842|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
69843|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
69844|NCT01111331|Secondary|Warfarin R-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
69845|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
69846|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
69847|NCT01111331|Secondary|Warfarin R-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
69848|NCT01111331|Secondary|Warfarin R-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
69849|NCT01111331|Secondary|Empagliflozin: Apparent Volume of Distribution Following Extravascular Administration (Vz/F,ss)|"Apparent volume of distribution during the terminal phase at steady state following extravascular administration.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||L||Geometric Coefficient of Variation|Geometric Mean
69850|NCT01111331|Secondary|Empagliflozin: Apparent Clearance at Steady State (CL/F,ss)|"Apparent clearance in plasma after extravascular administration at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||mL/min||Geometric Coefficient of Variation|Geometric Mean
69851|NCT01111331|Secondary|Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss)|"Mean residence time of empagliflozin (empa) in the body at steady state after oral administration.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
69852|NCT01111331|Secondary|Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss)|"Time from last dosing to maximum plasma concentration at steady state over a uniform dosing interval τ.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Full Range|Median
69853|NCT01111331|Secondary|Empagliflozin: Terminal Half-life at Steady State (t1/2,ss)|"Terminal half-life of empagliflozin (empa) in plasma at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||h||Geometric Coefficient of Variation|Geometric Mean
69854|NCT01111331|Secondary|Empagliflozin: Terminal Rate Constant at Steady State (λz,ss)|"Terminal rate constant of empagliflozin (empa) in plasma at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
69855|NCT01111331|Secondary|Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N)|Plasma concentration of empagliflozin (empa) measured 24 hours after administration of the fourth dose (Cpre,5) and after the sixth dose (Cpre,7).|24 hours after dose 4 or 6 respectively (day 5 and day 7)|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
69856|NCT01111331|Primary|Warfarin S-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
69857|NCT01111331|Primary|Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
69858|NCT01111331|Primary|Warfarin R-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
69859|NCT01111331|Primary|Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
69860|NCT01111331|Primary|Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss)|"Maximum measured plasma concentration of empagliflozin (empa) for the dosing interval τ at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
69871|NCT01111318|Secondary|Terminal Rate Constant (λz)|"Terminal rate constant in plasma.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||1/h||Standard Deviation|Mean
69861|NCT01111331|Primary|Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss)|"Area under the plasma concentration-time curve for the dosing interval τ at steady state~In addition to the specified time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
69862|NCT01111318|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).|Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days|Treated Set (TS) included all subjects who had been dispensed study medication and were documented to have taken the investigational treatment.||participants|||Number
69863|NCT01111318|Secondary|Urinary Glucose Excretion (UGE)|"Urinary glucose excretion, this endpoint was measured using Ae0-96.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||mg||Standard Deviation|Mean
69864|NCT01111318|Secondary|Renal Clearance After Extravascular Administration (CL R)|"Renal clearance of empagliflozin (empa) in plasma after extravascular administration.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||mL/min||Standard Deviation|Mean
69865|NCT01111318|Secondary|Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))|"Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||percentage of empagliflozin||Standard Deviation|Mean
69866|NCT01111318|Secondary|Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)|"Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol||Standard Deviation|Mean
69867|NCT01111318|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||L||Standard Deviation|Mean
69868|NCT01111318|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||mL/min||Standard Deviation|Mean
69869|NCT01111318|Secondary|Mean Residence Time (MRTpo)|"Mean residence time of empagliflozin (empa) in the body.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||h||Standard Deviation|Mean
69870|NCT01111318|Secondary|Terminal Half-Life (t1/2)|"Terminal half-life of empagliflozin (empa) in plasma.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||h||Standard Deviation|Mean
69884|NCT01111240|Secondary|Patients Global Assessment of Disease Activity Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
69872|NCT01111318|Secondary|Time From Dosing to Maximum Concentration (Tmax)|Time from dosing to maximum concentration of empagliflozin (empa) in plasma.|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||h||Full Range|Median
69873|NCT01111318|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol*h/L||Standard Deviation|Mean
69874|NCT01111318|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol/L||Standard Deviation|Mean
69875|NCT01111318|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.||nmol*h/L||Standard Deviation|Mean
69876|NCT01111292|Primary|The Effect of Myo-inositol (Inositol) on P-β-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia.|The primary objective of this study will be to evaluate the effect of myo-inositol (inositol), administered for three months, on P-β-catenin staining in areas of low grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline.|Baseline to 90 days|pβ-cat-positive cell counts in pre- and post-study biopsies with dysplasia or adenoma. Counts are broken down as the number of crypts with 3, 4, or 5 pβ-cat positive cells. High frequency (HF) fields of view are those containing at least 2 crypts with three or more pβ-cat positive cells per crypt (at 20X). I||Colonic Biopsies||Standard Deviation|Mean
69877|NCT01111240|Secondary|Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication|Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs|Baseline, and Months 6 and 24|FAS||percentage of participants|||Number
69878|NCT01111240|Secondary|Percentage of Participants With In-Patient Hospitalization|Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||percentage of particpants|||Number
69879|NCT01111240|Secondary|Mean Number of Days Missed From Work Due to Psoriatic Arthritis|Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||days||Standard Deviation|Mean
69880|NCT01111240|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit||Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||percentage of participants|||Number
69881|NCT01111240|Secondary|Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time|A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
69882|NCT01111240|Secondary|Participants Assessment of Pain Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
69883|NCT01111240|Secondary|Participants Assessment of Fatigue Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||scores on a scale||Standard Deviation|Mean
69920|NCT01111149|Primary|Smoking Abstinence - Serum/Urine Measurements|Measured by blood/urine tests for nicotine and its break-down product cotinine.|Week 12|||ng/mL||Standard Deviation|Mean
69885|NCT01111240|Secondary|Mean C-Reactive Protein (CRP) Levels Over Time|The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||mg/L||Standard Deviation|Mean
69886|NCT01111240|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Over Time|The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||mm/hour||Standard Deviation|Mean
69887|NCT01111240|Secondary|Number of Participants by Severity of Nail Psoriasis Levels Over Time|Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||participants|||Number
69888|NCT01111240|Secondary|Number of Participants by Severity of Dactylitis Over Time|Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to “sausage digit,” involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||participants|||Number
69889|NCT01111240|Secondary|Number of Participants by Severity of Enthesitis Over Time|Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||participants|||Number
69890|NCT01111240|Primary|Number of Participants With Adverse Events (AEs)|Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.|Baseline up to 24 months|Safety Set - All enrolled participants||participants|||Number
69891|NCT01111240|Primary|Mean Target Lesion Score (TLS) Over Time|The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||score on a scale||Standard Deviation|Mean
69892|NCT01111240|Primary|Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time|Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient’s hand was equal to 1% BSA.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||percentage of body surface area||Standard Deviation|Mean
69893|NCT01111240|Primary|Mean Swollen Joint Count (SJC) Over Time|Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||Swollen Joints||Standard Deviation|Mean
69894|NCT01111240|Primary|Mean Tender Joint Count (TJC) Over Time|Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||Tender joints||Standard Deviation|Mean
69972|NCT01110239|Primary|Number of Patients With Deep Vein Thrombosis for Safety Assessment.||90 days|||participants|||Number
69895|NCT01111240|Primary|Mean Change From Baseline in Disease Activity Score (DAS)28|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.||score on a scale||Standard Deviation|Mean
69896|NCT01111162|Primary|Immunogenicity|Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose.|21-28 days|Among the 90 participants without evidence of previous exposure to H1N1, only 61% [95% confidence interval (CI) 51–71] developed protective titers by week 3 of the study (seroconversion rate).||percentage of seroconversion||95% Confidence Interval|Number
69897|NCT01111162|Primary|Safety|"To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care).~Safety was assessed via~Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses.~Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination."|21-28 days|||percentage of participants|||Number
69898|NCT01111149|Secondary|Abnormal Movements - AIMS|Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167.|Week 12|||units on a scale||Standard Deviation|Mean
69899|NCT01111149|Secondary|Urge to Smoke - MNWS|The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke.|Week 12|||percentage of time||Standard Deviation|Mean
69900|NCT01111149|Secondary|Abstinence Related Symptoms - WISDM|The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154.|Week 12|||units on a scale||Standard Deviation|Mean
69901|NCT01111149|Secondary|Response Style Indicator (Beta) for CPT|Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12.|Week 12|||Beta||Standard Deviation|Mean
69902|NCT01111149|Secondary|Detectibility (d') of Continuous Performance Test|The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12.|Week 12|||unitless||Standard Deviation|Mean
69903|NCT01111149|Secondary|Variability of Standard Error - CPT|"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures within respondent variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12."|Week 12|||milliseconds||Standard Deviation|Mean
69904|NCT01111149|Secondary|Hit Reaction Time - CPT|The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12.|Week 12|||milliseconds||Standard Deviation|Mean
69905|NCT01111149|Secondary|General Psychopathology|Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267.|Week 12|||units on a scale||Standard Deviation|Mean
69906|NCT01111149|Secondary|Positive Symptoms of Schizophrenia (SAPS)|Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms.|Week 12|||units on a scale||Standard Deviation|Mean
69907|NCT01111149|Secondary|Suicidality|The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity.|Week 12|||units on a scale||Standard Deviation|Mean
69908|NCT01111149|Secondary|Vital Signs - Pulse|Pulse will be measured. The values below were measured at week 12 of the study.|Week 12|||heart beats per minute||Standard Deviation|Mean
69909|NCT01111149|Primary|Smoking Abstinence - Exhaled Carbon Monoxide|Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.|Week 12|||parts per million||Standard Deviation|Mean
69910|NCT01111149|Primary|Smoking Abstinence - Number of Cigarettes Smoked|Number of cigarettes smoked at week 12 of the study by self-report.|Week 12|||number of cigarettes smoked||Standard Deviation|Mean
69911|NCT01111149|Secondary|Vital Signs - Weight|Weight will be measured for each participant. Values listed below are for week 12.|Week 12|||lbs||Standard Deviation|Mean
69912|NCT01111149|Secondary|Vital Signs|blood pressure will be measured.|Week 12|||mm Hg||Standard Deviation|Mean
69913|NCT01111149|Secondary|Abnormal Movements - BAS and SAS|"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.~Simpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity."|Week 12|||units on a scale||Standard Deviation|Mean
69914|NCT01111149|Secondary|Depression|Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression.|Week 12|||units on a scale||Standard Deviation|Mean
69915|NCT01111149|Secondary|Abstinence-related Symptoms - MNWS and FTND|"Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges.~The Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine."|Week 12|||units on a scale||Standard Deviation|Mean
69916|NCT01111149|Secondary|Side Effects|Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study.|Week 12|||participants|||Number
69917|NCT01111149|Secondary|Impulsivity and Inattention|Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity.|Week 12|||Percentage of responses||Standard Deviation|Mean
69918|NCT01111149|Secondary|Negative Symptoms of Schizophrenia - SANS|Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms.|Week 12|||units on a scale||Standard Deviation|Mean
69919|NCT01111149|Secondary|Reduction in Smoking|Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12|Week 12|||participants|||Number
69921|NCT01111123|Secondary|Signs of Psoriasis, Atrophy or Telangiectasis|Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the ITT.||participants|||Number
69922|NCT01111123|Primary|Physical Global Assessment|Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the intention-to-treat population (ITT).||participants|||Number
69923|NCT01111110|Primary|Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber|fifteen minutes after 4 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||Diff in % change from 4AM||Standard Deviation|Mean
69924|NCT01111110|Primary|Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber|15 minutes after 2 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||Diff in % change from 4AM||Standard Deviation|Mean
69925|NCT01111110|Primary|Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber|fifteen minutes after 1 puff of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||Diff in % change from 4AM||Standard Error|Mean
69926|NCT01110967|Primary|Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)||Patients were followed up according to the local practice, up to 1 year|||events|||Number
69927|NCT01110967|Secondary|Changes in Device Placement||Up to 12 months follow up visit|||participant|||Number
69928|NCT01110967|Secondary|Device Subsidence Measured as Interbody Height Ratio (IBHR)|Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.|Up to 12 months follow up visit|||ratio||Standard Deviation|Mean
69929|NCT01110967|Secondary|Intervertebral Disc Space (IVD) at Implanted Level|The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as [(A+B)/2]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.|Up to 12 months follow up visit|||mm||Standard Deviation|Mean
69930|NCT01110967|Secondary|Range of Motion (ROM) at Implanted Level|The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).|Up to 12 months follow up visit|||degrees||Standard Deviation|Mean
69931|NCT01110967|Primary|Physical Functioning Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.|Up to 12 months follow up visit|||units on a scale||Standard Deviation|Mean
69932|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit|||units on a scale||Standard Deviation|Mean
69933|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Back Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit|||units on a scale||Standard Deviation|Mean
69934|NCT01110915|Secondary|System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to four months post implant|||participants|||Number
69935|NCT01110915|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the AEAC.|During MRI scans|All subjects successfully implanted with the Advisa MRI system who underwent MRI scans were included in the analysis. All MRI scans, whether done at the 9-12 week visit in the MRI group, or done at other times in either group were included in this analysis.||participants|||Number
70005|NCT01109316|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.||Units (U) of insulin||Standard Deviation|Mean
69936|NCT01110915|Secondary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.||participants|||Number
69937|NCT01110915|Secondary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.||participants|||Number
69938|NCT01110915|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.||participants|||Number
69939|NCT01110915|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.||participants|||Number
69940|NCT01110915|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.|MRI scan to one-month post-MRI scan|Subjects who had an MRI scan and completed their 4-month visit (or a later follow-up), or had an MRI-related complication within one month post-MRI were included in the analysis.||participants|||Number
69941|NCT01110499|Primary|Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.|Baseline, Day 29|Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
69942|NCT01110499|Primary|Part 1: Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.|Baseline, Day 7|Safety Population: all treated patients||Millimeters of Mercury (mmHg)|Participants|Standard Deviation|Mean
69943|NCT01110421|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
69944|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
69983|NCT01109602|Secondary|Balance Self-efficacy - Measured With the Activities Balance Confidence Scale|The 16 item Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. The ABC is a self-report of a participant's self-efficacy in maintaining static and dynamic balance control during functional tasks. The validity and reliability of the ABC have been previously demonstrated in individuals with stroke. Scoring is 'no confidence' (0%) to 'completely confident' (100%).|2 months|||units on a scale||Standard Deviation|Mean
69945|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
69946|NCT01110421|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response Rate|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.||Participants|||Number
69947|NCT01110421|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms showed no evidence of resurgence after administration of the last dose of study medication and no nonstudy systemic antibacterial therapy was given for the treatment of pneumonia.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract (LRT) culture, pleural fluid or blood culture.||Participants|||Number
69948|NCT01110421|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|Participants were considered as clinical improved if they had no fever, clinical improvement in signs and symptoms of pneumonia from baseline, decrease in WBC, improvement or lack of progression of radiographic findings in comparison with the screening chest X-ray, and not received any nonstudy systemic antibacterial therapy for the treatment of pneumonia after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical intent-to-treat: All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.||Participants|||Number
69949|NCT01110421|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-To-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.||Participants|||Number
69950|NCT01110408|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
69951|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
70042|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 144||Baseline to Week 144|Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.||cells/μL||Standard Deviation|Mean
69952|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
69953|NCT01110408|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.||Participants|||Number
69954|NCT01110408|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.||Participants|||Number
69955|NCT01110408|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.||Participants|||Number
69956|NCT01110408|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.||Participants|||Number
69957|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated at baseline from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
69958|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
69984|NCT01109576|Primary|Change in Profile of Mood States Total Score.|The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.|Change in Profile of Mood States Score from Baseline to 8 Weeks|||units on a scale||Standard Deviation|Mean
70043|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.||cells/μL||Standard Deviation|Mean
69959|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
69960|NCT01110382|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.||participants|||Number
69961|NCT01110382|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.||participants|||Number
69962|NCT01110382|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms of the intra-abdominal infection, no fever, decrease in WBC, and not received any nonstudy antibiotics for the treatment of intra-abdominal infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.||participants|||Number
69963|NCT01110382|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.||participants|||Number
69964|NCT01110330|Secondary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6|Overall Cure (OC) was defined as Mycological Cure (MC) in addition to a global clinical evaluation of either ‘Completely Cleared’ (clearance of all signs and symptoms of Tinea pedis) or ‘Marked Improvement’ (significant improvement of signs and symptoms of Tinea pedis; residual signs and symptoms only), assessed at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Secondary Outcome Measure.||participants|||Number
69965|NCT01110330|Primary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6|Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary Outcome Measure.||participants|||Number
69966|NCT01110252|Primary|Vital Capacity - VC|A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure.||liters||Standard Deviation|Mean
69967|NCT01110252|Secondary|Arterial Blood Gases Test - Pa CO2|presence of CO2 in the arterial blood.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure||mm Hg||Standard Deviation|Mean
69968|NCT01110252|Secondary|Arterial Blood Gases Test - Pa O2|presence of oxygen in the blood gases.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure.||mmHg||Standard Deviation|Mean
69969|NCT01110252|Primary|Forced Expiratory Volume (FEV1)|A pulmonary function test that measures the volume and speed of the exhaled air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure||liters||Standard Deviation|Mean
69970|NCT01110252|Primary|Forced Vital Capacity (FVC)|A pulmonary function test that measures the volume and speed of the inhalated air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure||liters||Standard Deviation|Mean
69971|NCT01110239|Primary|Visual Analog Scale Score as a Measure of Tolerability|The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.|90 days|We escalated the ischemia times in cohorts of 6. Cohorts of 6 were prespecified at the beginning to the study. All analysis was intention to treat||units on a scale||Standard Deviation|Mean
69973|NCT01110200|Secondary|Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population. Only those participants with an EX were assessed for hospitalization, treatment with OCSs, and treatment with ABs.||exacerbations|||Number
69974|NCT01110200|Secondary|Number of Participants With an EX of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population||participants|||Number
69975|NCT01110200|Primary|Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population. Only those participants with an EX requiring hospitalization were assessed.||Exacerbations|||Number
69976|NCT01110200|Primary|Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population||participants|||Number
69977|NCT01110200|Primary|Number of Par. With Chronic Obstructive Pulmonary Disease (COPD) EXs Requiring Hospitalization That Occurred >21 Days Post-discharge/Physician's Office Visit for a COPD EX Requiring Treatment With Oral Corticosteroids (OCSs) or OCSs and Antibiotics (ABs)|A COPD exacerbation (EX) was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur >21 days post-discharge/physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|Intent-to-Treat (ITT) Population: all participants randomized to study drug||participants|||Number
69978|NCT01110187|Secondary|Number of Participants With Seizures|Number of seizures in the first 72 hours based on EEG recording|baseline to 72 hours|||number of participants with seizures|||Number
69979|NCT01110187|Primary|Number of Adverse Events|The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.|baseline to 7 days|all participants in each arm were available for analyses||number of events experienced|||Number
69980|NCT01109979|Primary|Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)|This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increase in shear stress causes nitric oxide release and resulting vasodilation of the brachial artery (flow-mediated vasodilation). The flow-mediated changes in brachial artery diameter can be imaged by ultrasound and measured as an index of peripheral vasomotor function. BAR correlates with invasive assessments of coronary endothelial function as well as multiple cardiovascular risk factors.|%FMD after 6 weeks of treatment|The number of participants for analysis includes only the participants that completed a baseline assessment and at least one of the treatment arms.||% FMD after 6 weeks of treatment||Standard Deviation|Mean
69981|NCT01109602|Secondary|Quality of Life - Measured With the Stroke Specific Quality of Life|Quality of Life was measured using the validated 49 items of the Stroke Specific QoL scale (SSQoL). The SSQoL includes assessment of 12 domains: self-care; vision; language; mobility; work; upper extremity; thinking; personality; mood; family; social; and energy. Prior work indicates good psychometric properties. Higher scores indicate increased QoL. Range of scores is 13 to 65 for the total score.|2 months|||units on a scale||Standard Deviation|Mean
69982|NCT01109602|Primary|Balance - Measured With the Berg Balance Scale|Balance was assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable and valid after stroke. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.|2 months|||units on a scale||Standard Deviation|Mean
69985|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population|Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship. Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0). Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less. Day 1=start of study drug; to 30 days after last dose of any treatment.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.||participants|||Number
69986|NCT01109524|Primary|Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship. AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.||participants|||Number
69987|NCT01109524|Primary|Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 – 155 mmol/L; Gr 3: >155 – 160mmol/L; Gr 4: >160 mmol/L. Sodium low(L) Gr 1:<LLN – 130mmol/L; Gr 3: <130 – 120 mmol/L; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5 mmol/L; Gr 2: >5.5 – 6.0 mmol/L; Gr 3: > 6.0 – 7.0 mmol/L; Gr 4: >7.0 mmol/L. Potassium (L) Gr 1: <LLN – 3.0 mmol/L; Gr 2: <LLN – 3.0 mmol/L; Gr 3: < 3.0 – 2.5 mmol/L; Gr 4: <2.5 mmol/L. Serum creatinine (H) Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.||participants|||Number
69988|NCT01109524|Primary|Number of Participants With Hematology Laboratory Abnormalities - Treated Population|Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10^9/μL.|Day 2 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug. Participants with at least one on-study laboratory measurement available were analyzed.||participants|||Number
69989|NCT01109524|Primary|Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN. Albumin (low) Grade 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Grade 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Grade 3: < 2 g/dL to <2 g/L. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Number (N) of participants with laboratory data available and who could be analyzed for total bilirubin was 49. All other liver function laboratories N=57. Treated population: all participants who received at least one dose of any study drug.||participants|||Number
69990|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population|Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.||participants|||Number
70003|NCT01109316|Secondary|Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%||8 weeks for each treatment|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.||participants|||Number
70004|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values||Baseline, 8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
69991|NCT01109524|Primary|Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.||participants|||Number
69992|NCT01109381|Secondary|Assessment of Adverse Events (AE)|Adverse event data will be collected in response to neutral questioning.|AE commencing within 30 days of initiation of treatment, followed until resolution|All participants entering the study are included in the safety analysis||participants|||Number
69993|NCT01109381|Primary|Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)|Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).|up to 14 days of treatment|All 21 Initial Phase participants had a pretreatment gastroscopy, and 20 had post-treatment gastroscopy (one participant prematurely discontinued the study prior to receiving GT08, and the participant later lost to follow up had a post-treatment gastroscopy before being lost to follow up)||participants|||Number
69994|NCT01109381|Primary|Number of Participants With Eradication of H.Pylori Infection|Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment|4-6 weeks following treatment|Two participants did not complete the study, one discontinuing after experiencing adverse events while receiving only the initial study omeprazole, and the other participant left Singapore before they had their final urea breath test. All other study participants were analysed for efficacy.||participants|||Number
69995|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.||mmHg||Standard Deviation|Mean
69996|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.||kilograms (kg)||Standard Deviation|Mean
69997|NCT01109316|Secondary|Hypoglycemia Episode Rate Per 30 Days|"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||hypoglycemic episodes per 30 days||Standard Deviation|Mean
69998|NCT01109316|Secondary|Percentage of Participants With Hypoglycemia|"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L)."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.||percentage of participants|||Number
69999|NCT01109316|Secondary|Pump Complication Rate Per 30 Days|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||pump complications per 30 days||Standard Deviation|Mean
70000|NCT01109316|Secondary|Percentage of Participants With Pump Complications|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.||percentage of participants|||Number
70001|NCT01109316|Secondary|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||hyperglycemic episodes per 30 days||Standard Deviation|Mean
70002|NCT01109316|Secondary|Percentage of Participants With Hyperglycemia|Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.||percentage of participants|||Number
70006|NCT01109316|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on Day 2 for insulin lispro 2 day or Day 6 for the respective treatment arm: insulin lispro 6 day and insulin aspart 6 day.||mmol/L||Standard Deviation|Mean
70007|NCT01109316|Primary|Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use||8 weeks of each treatment|All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.||millimoles per liter (mmol/L)||Standard Deviation|Mean
70008|NCT01109173|Secondary|Percentage of Patients Pain-Free at Day 14|Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.||percentage of participants|||Number
70009|NCT01109173|Primary|Percentage of Patients Cured at Day 14|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe – very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.||percentage of participants|||Number
70010|NCT01109147|Primary|Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)|"During the fMRI session, the activation of each brain circuits is measured by a Bold signal (an arbitrary measure of contrast: numbers of voxels highlighted/activated in the region of interest).~The emotional task is composed by congruent and incongruent images. Three effects were caused by the task: congruence, attention and valence effects. Each of them affect, involve and activate the regions of interests differentially within the differents arms.~The region of interests who were mainly observed are: Anterior Cingulate Cortex (ACC), Prefrontal dorso-lateral Cortex (PFdlC) and the Amygdala (A)."|3 days after the decision of inclusion|||arbitrary units of activation||Standard Error|Mean
70011|NCT01109147|Secondary|Investigate the Level of Expression of Candidate Genes||one blood sample||||||
70012|NCT01109147|Secondary|Assessment of Personality Traits||3 days after the decision of inclusion||||||
70013|NCT01109147|Secondary|Assessment of Cognitive and Attentional Abilities||3 days after the decision of inclusion||||||
70014|NCT01109147|Secondary|Assessment of Emotional Reactivity||3 days after the decision of inclusion||||||
70015|NCT01109056|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16|Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Week 16|Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia||Scores on a Scale||Standard Deviation|Mean
70016|NCT01109056|Primary|Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16|Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.|Baseline, Week 16|"Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"||Scores on a Scale||Standard Deviation|Mean
70017|NCT01109056|Primary|Number of Pterygium Hyperemia Responders at Week 16|Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.|Week 16|"Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"||Participants|||Number
70018|NCT01108809|Secondary|Number of Patients With Adverse Events (AE)||6 months|Treated patients||Number of participants|||Number
70019|NCT01108809|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (6 months)|Patients with data at 3rd visit||Number of participants|||Number
70020|NCT01108809|Secondary|Change in Heart Rate From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||beats / minute||Standard Deviation|Mean
70021|NCT01108809|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)||6 Months|Patients with data at 3rd visit||Percentage of participants|||Number
70022|NCT01108809|Secondary|Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|Visit 3 (6 months from baseline)|Patients with data at 3rd visit||Percentage of participants|||Number
70023|NCT01108809|Primary|Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End|ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||Percentage of participants|||Number
70044|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.||cells/μL||Standard Deviation|Mean
70024|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||Percentage of participants|||Number
70025|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||Percentage of participants|||Number
70026|NCT01108809|Primary|Change in Diastolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||mmHg||Standard Deviation|Mean
70027|NCT01108809|Primary|Change in Systolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit||mmHg||Standard Deviation|Mean
70028|NCT01108796|Secondary|Assessment of Metabolic Effect|Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'|24 weeks (Visit 1 to Visit 3)|||Participants|||Number
70029|NCT01108796|Secondary|Changes in Laboratory Parameters: Blood Glucose|Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
70030|NCT01108796|Secondary|Changes in Laboratory Parameters: Triglycerides|Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
70031|NCT01108796|Secondary|Changes in Laboratory Parameters:High Density Lipoprotein (HDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
70032|NCT01108796|Secondary|Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmol/l||Standard Deviation|Mean
70033|NCT01108796|Primary|Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmHg||Standard Deviation|Mean
70034|NCT01108796|Primary|Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)|||mmHg||Standard Deviation|Mean
70035|NCT01108731|Secondary|Change in Widespread Pain|Pain was assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever). The baseline value recorded was widespread pain at the time of assessment and the 2 months follow value recorded was widespread pain over the week prior to assessment.|2 months|Data from all 26 participants were used for analysis.||units on a scale||Standard Deviation|Mean
70036|NCT01108731|Secondary|Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).|The Attention Network Test (ANT) is a computerized test designed to evaluate the efficiency of the attention network. The ANT consists of a set of cued reaction time tasks to assess vigilance and efficiency to detect novel visual stimuli. The ANT also includes a set of flanker tasks during which a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Scores on the cued reaction time tasks (no cue, centre cue, double cue) reflect latency to respond measured in milliseconds (slower performance equals greater values). The score on the flanker task reflecting executive attention is derived by subtracting obtained latencies on the congruent flanker from the incongruent condition. Based on our prior work, we are hypothesizing that drug treated Ss will show improved performance on the no cue reaction time condition and on the derived executive attention variable compared to placebo treated.|Baseline and 2 months|Data from 4 were excluded due to 2 having error rates greater than 50%, indicating that they did not understand the task and 2 having simple reaction times longer than those for the complex reaction times on the ANT, suggesting their need for additional practice trials on the simple motor reaction time task.||latency to respond (msecs.)||Standard Deviation|Mean
70037|NCT01108731|Primary|Change in Ventricular Lactate Levels in the Brain|Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.|Baseline and 2 months|One drug treated and two placebo treated could not be analyzed due to excessive head motion||international units (iu)||Standard Deviation|Mean
70038|NCT01108718|Primary|Mattress Preference of Fibromyalgia Patients|Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.|6 months|Following 2 months use of each test mattress, the study patients' sleep patterns and severity of fibromyalgia symptoms were assessed. At the end of the study, study patients were asked to rate each mattress in order of preference.||percentage of study participants|||Number
70039|NCT01108523|Secondary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys||4, 8, 12, and 15 days||||||
70040|NCT01108523|Primary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.||15 Days||||||
70041|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 192||Baseline to Week 192|Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.||cells/μL||Standard Deviation|Mean
70045|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.|Week 192|Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.||percentage of participants|||Number
70046|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.|Week 144|ITT Analysis Set||percentage of participants|||Number
70047|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.|Week 96|ITT Analysis Set||percentage of participants|||Number
70048|NCT01108510|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Intent-to-Treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
70049|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and end of treatment per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, up to 40 months|All participants who completed the End of treatment visit.||units on a scale||Standard Deviation|Mean
70050|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 6 day1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 6 day 1|All participants who completed the cycle 6 day 1 visit.||units on a scale||Standard Deviation|Mean
70051|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 3 day 1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 3 day 1|All participants who completed the cycle 3 day 1 visit.||units on a scale||Standard Deviation|Mean
70052|NCT01108445|Secondary|Percentage of Participants With Adverse Events|To assess toxicities associated with everolimus or sunitinib using NCI CTC version 4.0 criteria|24 months|||percentage of participants||95% Confidence Interval|Number
70053|NCT01108445|Secondary|Time-to-new Metastatic Disease in Each Treatment Arm|To compare the time-to-new metastatic disease in each treatment arm, defined from the date of first study agent administration to the onset of a new evaluable site of disease, excluding the primary site and all sites documented at baseline|36 months|||months||95% Confidence Interval|Median
70054|NCT01108445|Secondary|Median OS|To compare the median OS in each treatment arm.|Up to 40 months|||months||95% Confidence Interval|Median
70055|NCT01108445|Secondary|Median Duration of Response (CR, PR, and SD)|To compare the median duration of response (CR, PR, and SD) in each treatment arm. According to RECIST 1.1, Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|24 months|||months||Inter-Quartile Range|Median
70056|NCT01108445|Secondary|Changes in Copy Number, RNA Expression, and Immunohistochemical Profiles|To evaluate in an exploratory fashion changes in copy number, RNA expression, and immunohistochemical profiles by microarray between primary non-clear cell RCC tumors and metastatic samples|36 months||||||
70057|NCT01108445|Secondary|Clinical Measures of Response and PFS With Baseline and Time-dependent Levels of Biomarkers|To correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. These biomarkers include plasma angiokine levels, tissue immunohistochemical and genomic profiles, copy number as assessed by array-based comparative genomic hybridization (CGH), and known mutations in non-clear cell RCC|36 months||||||
70058|NCT01108445|Secondary|Best Tumor Shrinkage as a Percentile in Each Arm|To compare the best tumor shrinkage as a percentile in each treatment arm. The percentile change at each follow up visit is calculated by measuring the percentage change in the Sum of lesion measurement from baseline. The best tumor shrinkage is lowest percentile change. A decrease is indicated by a negative percentage.|24 months|||percentile decrease||Inter-Quartile Range|Median
70059|NCT01108445|Secondary|Overall Survival Rates|To compare overall survival (OS) rates at 6, 12, 24, and 36 months and over time in each treatment arm.|6, 12, 24, 36 months|||percentage probability||95% Confidence Interval|Number
70075|NCT01108237|Primary|Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films|Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.|12 weeks postoperatively (when subject has reached full knee extension)|||Absolute value in degrees||Standard Deviation|Least Squares Mean
70060|NCT01108445|Secondary|12 Week Clinical Benefit Rate as Percentage|Rate of complete or partial response or stable disease by the RECIST 1.1 criteria lasting ≥ 12 weeks prior to progression. Benefit rate is defined as complete response [CR] and partial response [PR] and stable disease [SD] by RECIST 1.1 criteria in each treatment arm. Benefit rate = CR + PR + SD. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months|||percentage of particpants||95% Confidence Interval|Number
70061|NCT01108445|Secondary|Percentage of Participants With Stable Disease (SD)|Percentage of participants with stable disease during treatment is defined as stable disease [SD] by RECIST 1.1 criteria as calculated in each treatment arm. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months|||percentage of participants||95% Confidence Interval|Number
70062|NCT01108445|Secondary|Overall Response Rate|Defined as complete response [CR] and partial response [PR] by RECIST 1.1 criteria in each treatment arm.Overall Response Rate (ORR) = CR + PR. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|24 months|||percentage of participants||95% Confidence Interval|Number
70063|NCT01108445|Secondary|PFS Expressed in Months|Progression-free survival (PFS) expressed in months as compared to an historic control (interferon-treated clear cell RCC control arm from the sunitinib phase III study). Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 months|||Months||95% Confidence Interval|Median
70064|NCT01108445|Secondary|Progression Free Survival Rates|6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|6, 12 and 24 months|||percentage of participants||95% Confidence Interval|Number
70065|NCT01108445|Primary|Anti-tumor Activity as Measured by Median Progression Free Survival Time|The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 Months|||Months||80% Confidence Interval|Median
70066|NCT01108406|Secondary|Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) , a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).|3 months and 6 months|||Global Benefit Score||Standard Deviation|Mean
70067|NCT01108406|Primary|Long Term Safety|The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.|6 months|||participants|||Number
70068|NCT01108341|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|up to Week 32|Safety population of participants who were treated||percentage of participants||95% Confidence Interval|Number
70069|NCT01108341|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|up to Week 32|Safety population of participants who were treated||percentage of participants||95% Confidence Interval|Number
70070|NCT01108263|Secondary|Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.||12 weeks|||participants|||Number
70071|NCT01108263|Primary|Overall Decrease in Wound Size||12 weeks|||participants|||Number
70072|NCT01108237|Secondary|Sagittal Component Alignment||Pre-Op, 3 months||||||
70073|NCT01108237|Secondary|Compare AP Tibial/Femoral Component Alignment||Pre-op, 3 months||||||
70074|NCT01108237|Secondary|Compare Intraoperative Time Data (Skin-to-skin, Tourniquet, Tourniquet to Bone)||During the Procedure||||||
70076|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.||Participants|||Number
70077|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized.|Day 0|The per-protocol population was analyzed.||Participants|||Number
70078|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented.|Day 10 - 16|||Participants|||Number
70079|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented.|Day 0|The per-protocol population was analyzed.||Participants|||Number
70080|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented.|Day 10 - 16|The per-protocol population was analyzed.||Participants|||Number
70081|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented.|Day 0|The per-protocol population was analyzed.||Participants|||Number
70082|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.||Percentage|||Number
70083|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized.|Day 0|The per-protocol population was analyzed.||Percentage|||Number
70084|NCT01108185|Primary|The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events|The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.|Day 0 through Days 10 - 16|The per-protocol population was analyzed.||Participants|||Number
70085|NCT01108185|Primary|Compliance (Was the Dosage Followed - Yes, no)|Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.|Day 10 - 16|The per-protocol population was analyzed.||Participants|||Number
70086|NCT01108081|Secondary|Change Over 6 Months in Quality of Life|Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Functional Outcomes of Sleep Questionnaire scores. One participant in Diet arm and one participant in Health education arm.||units on a scale||Standard Error|Mean
70087|NCT01108081|Primary|Change Over 6 Months in Epworth Sleepiness Scale Score|Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Epworth Sleepiness Scale scores. One participant in Diet arm and one participant in Health education arm.||units on a scale||Standard Error|Mean
70088|NCT01108003|Secondary|Apoptosis, Cell Proliferation, and Microvessel Density||1 year|Due to the study's early termination and low accrual, data were not collected for this assessment.|||||
70089|NCT01108003|Primary|Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0|Number of participants with an adverse event.|14 days|All treated and eligible patients.||participants|||Number
70090|NCT01107925|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy|MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline , Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percent aggregation||Standard Deviation|Mean
70180|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.||hours||Full Range|Median
70181|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
70091|NCT01107925|Secondary|Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)|A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|baseline (pre-dose) up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.||nanogram•hour/milliliter (ng•hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
70092|NCT01107925|Secondary|Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||P2Y12 reaction units (PRU)||Standard Deviation|Mean
70093|NCT01107925|Secondary|Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy|VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percentage PRI||Standard Deviation|Mean
70094|NCT01107925|Primary|Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)|MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|Primary intent-to-treat (ITT) pharmacodynamic (PD) population: all randomized participants who continued in the study through Day 12, and had at least 1 evaluable PD assessment at Day 12. Participants were analyzed based on the treatment group they were randomized to irrespective to the treatment they received.||percent aggregation||Inter-Quartile Range|Median
70095|NCT01107912|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percentage of aggregation||Standard Deviation|Mean
70096|NCT01107912|Secondary|Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing|A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|Baseline up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.||nanogram*hour/milliliter (ng*hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
70097|NCT01107912|Secondary|Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||P2Y12 reaction units (PRU)||Standard Deviation|Mean
70098|NCT01107912|Secondary|Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy|Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.||percentage platelet reactive index (PRI)||Standard Deviation|Mean
78010|NCT01020123|Secondary|Sodium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 215 in CSR)||mEq/L||Standard Deviation|Mean
70099|NCT01107912|Primary|Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.|Baseline, 12 days|All randomized participants who continued in the study through the Day 12 visit, and who had at least 1 evaluable PD assessment at the Day 12 visit. Participants were analysed based on randomized treatment assignment, regardless of the study drug they took.||percentage of aggregation||Inter-Quartile Range|Median
70100|NCT01107899|Secondary|Platelet Function by Multiplate® ADP Test and ADP Test HS|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM PGE1 (ADP test HS), area under the aggregation curve (AUC) were calculated.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.||aggregation units*minute||Standard Deviation|Mean
70101|NCT01107899|Secondary|Platelet Function by LTA at 5 and 20 μM ADP|MPA to 5 and 20 μM ADP were assessed by LTA.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.||percent aggregation||Standard Deviation|Mean
70102|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by Multiplate® ADP Test and ADP Test High Sensitivity (HS)|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADP test HS), area under the aggregation curve (AUC) was calculated. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
70103|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hours Post-LD) by LTA (5 and 20 μM ADP)|Maximum platelet aggregation (MPA) to 5 and 20 μM ADP were assessed by LTA. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
70104|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)|Return of baseline platelet function was assessed by Multiplate® ADP test and ADP test High Sensitivity (HS). Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. The agonist ADP was added to stirred whole blood after dilution (1:2 with 0.9% NaCl solution) in a final concentration of 6.4 µM (ADP Test) or in final concentration of 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADPtest HS). Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve (AUC=AU*min) of aggregation units (AU).|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.||Aggregation Units * minutes||90% Confidence Interval|Mean
70105|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)|Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day.|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.||percent platelet aggregation||90% Confidence Interval|Mean
70106|NCT01107899|Secondary|Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD|Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements.||percentage of participants|||Number
70107|NCT01107899|Secondary|Platelet Function 24 Hours Post Loading Dose|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.||P2Y12 Reaction Units (PRU)||Standard Deviation|Mean
70108|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
70109|NCT01107899|Secondary|Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU|To show effect of initial inhibition of platelet aggregation as measured by Accumetrics Verify Now™ P2Y12 on the day to return to baseline platelet function, a regression model was fitted with day to return as outcome variable and initial inhibition as fixed effect. Results are reported as the predicted day to return to baseline platelet function by derived VN-PRU percent (%) inhibition at 24 hours post LD. The derived VN-PRU % inhibition is calculated as a percent decrease of PRU from baseline using the following formula: ([PRU at baseline - PRU at 24 hours post LD]/PRU at baseline) x 100%.|Up through 11 days|ITT Washout Population: All randomized participants who received study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. One participant discontinued on Day 3 without returning to baseline and is not included in analysis.||days|||Number
70182|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 1|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
70110|NCT01107899|Secondary|Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)|The return of baseline platelet function following one LD of prasugrel (30 mg or 60 mg) or 600 mg LD of clopidogrel assessed by Verify Now™ P2Y12 Reaction Units (VN-PRU). This outcome measure was not analyzed because it was not appropriate to estimate the days based on the non-inferiority approach due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days||Standard Deviation|Mean
70111|NCT01107899|Secondary|The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7|The day at which the proportion of participants who return to baseline platelet P2Y12 receptor function in the prasugrel 30 mg and 60 mg LD groups is similar (within 10% absolute difference) to the proportion of subjects who return to baseline platelet P2Y12 receptor function at day 5 and day 7 in the clopidogrel 600 mg LD group, obtained from Kaplan Meier curves for the primary washout population, was to be presented. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||day|||Number
70112|NCT01107899|Secondary|The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel|This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.||days|||Number
70113|NCT01107899|Primary|Percentage of Participants Returning to Baseline Platelet Function|Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation.|Days 3, 5, 7, 9, and 11|Primary Washout Population: Included participants who completed the study, had evaluable pharmacodynamic (PD) data through Day 11. Participants with a missed visit were not included in the Primary Washout Population.||percentage of participants|||Number
70114|NCT01107886|Secondary|Participants With Event of Death|Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.||participants|||Number
70115|NCT01107886|Secondary|Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation|Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.||participants|||Number
70116|NCT01107886|Primary|Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke|Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.||participants|||Number
70117|NCT01107834|Secondary|Myocardial Wall Velocity During Early Diastole|Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging|Baseline|||cm/s||Standard Error|Mean
70118|NCT01107834|Secondary|Early to Late Diastolic Filling Ratio|Early to late diastolic filling ratio measured by tissue Doppler echocardiography|Baseline|||ratio, unitless||Standard Deviation|Mean
70119|NCT01107834|Secondary|Systolic Myocardial Velocity During Systole (S')|Systolic myocardial velocity during systole measured by tissue Doppler echocardiography|Baseline|||cm/s||Standard Deviation|Mean
70120|NCT01107834|Secondary|Global Strain Rate|Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography|Baseline|||percentage of full deformation||Standard Deviation|Mean
70121|NCT01107834|Primary|Fractional Shortening|Fractional shortening measured by M-mode cardiography|Baseline|||percentage of full contraction||Standard Deviation|Mean
70122|NCT01107834|Primary|Left Ventricular Mass Index|left ventricular mass index measured by 2D echocardiography|Baseline|||g/m2||Standard Deviation|Mean
70123|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70124|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70125|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70126|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70127|NCT01107743|Secondary|Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70128|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70129|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70130|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70131|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70132|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70133|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70134|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, Class1, Class2, Class3, or Class4 is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70135|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70136|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70137|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70282|NCT01106534|Primary|Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70138|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70139|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70140|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70141|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70142|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70143|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70144|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
70145|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
70146|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
70147|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
70148|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
70149|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
70150|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
71192|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
70151|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina pectoris is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
70152|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
70153|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypertension is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
70154|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 years is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
70155|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.||participants|||Number
70156|NCT01107743|Secondary|Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Caduet. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
70157|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70158|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70159|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
70160|NCT01107743|Primary|Number of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.|8 weeks|The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.||participants|||Number
70161|NCT01107730|Primary|Incidence of Postoperative Atrial Fibrillation|The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.|Within the first 30 days (plus or minus 3 days)|||participants|||Number
70162|NCT01107535|Secondary|Number of Serious Adverse Events|The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.|Enrollment until 100 days after the last Synagis (palivizumab) dose|Analysis included all enrolled participants.||participants|||Number
70163|NCT01107535|Secondary|Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission|The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.|Hospital admission to hospital discharge|Analysis of supplemental oxygen included participants with any hospital stay during the study (n=10) and analysis of mechanical ventilation included the subgroup of participants with intensive care unit stays during the study (n=2).||days||Standard Deviation|Mean
78015|NCT01020123|Secondary|Pulse, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 236 in CSR)||Beats/min||Standard Deviation|Mean
70164|NCT01107535|Secondary|Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection|The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|Hospital admission to hospital discharge|Two participants with a total of 3 intensive care unit stays were analyzed. One participant was negative for respiratory syncytial virus during their first stay in the intensive care unit and was positive for respiratory syncytial virus at their second stay.||days|||Number
70165|NCT01107535|Secondary|Number of Hospital Admission Days (All Causes)|The mean (average) number days participants were hospitalized.|Hospital admission to hospital discharge|Analysis included all participants who were hospitalized during the study. This includes 2 participants hospitalized due to respiratory syncytial virus infection and 8 participants hospitalized for other respiratory diseases.||days||Standard Deviation|Mean
70166|NCT01107535|Primary|Number of Hospital Admissions by Respiratory Syncytial Virus Infection|The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|First year of life (up to 12 months)|Analysis included all enrolled participants.||participants|||Number
70167|NCT01107418|Primary|Accumulation Ratio of Vemurafenib on Day 15|Accumulation ratio was calculated as, AUC(0-8) on Day 15 divided by AUC(0-8) on Day 1.|Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1 and 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||ratio||Standard Deviation|Mean
70168|NCT01107418|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug administration to the date of death, regardless of the cause of death.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
70169|NCT01107418|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response. Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) were required to demonstrate a reduction to normal (short axis less than [<] 10 millimeters [mm]). PR was defined as a 30 percent (%) decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of confirmed CR or PR are reported.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Efficacy population: all enrolled participants who received at least one dose of vemurafenib, had measurable target lesions at baseline based on RECIST 1.1 criteria, had no major protocol violations of inclusion/exclusion criteria, and had no other violations affecting efficacy assessments.||percentage of participants|||Number
70170|NCT01107418|Primary|Terminal Elimination Half-Life (t1/2) of Vemurafenib on Day 15|Time measured for vemurafenib plasma concentrations to decrease by one-half (t1/2) was calculated as 0.693 divided by apparent first-order terminal elimination rate constant (0.693/kel).|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||hours||Standard Deviation|Mean
70171|NCT01107418|Primary|Apparent Clearance (CL/F) of Vemurafenib on Day 15|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||liters/hour (L/h)||Standard Deviation|Mean
70172|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||hours||Full Range|Median
70173|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg/mL||Standard Deviation|Mean
70174|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC[0-168h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
70175|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
70176|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
70177|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||hours||Full Range|Median
70178|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg/mL||Standard Deviation|Mean
70179|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.||mcg*h/mL||Standard Deviation|Mean
70183|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|Pharmacokinetic (PK) population included all participants who provided essential PK data up to and including the pre-dose PK sample taken on Cycle 1, Day 22, without major protocol violation.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
70184|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (initial challenge)|Visit 4 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
70185|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (initial challenge)|Visit 4 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
70186|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 3 (initial challenge)|Visit 3 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
70187|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 3 (initial challenge)|Visit 3 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||units on a scale||Standard Deviation|Mean
70188|NCT01107405|Primary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||Units on a scale||Standard Deviation|Mean
70189|NCT01107405|Primary|Ocular Itching|Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Ocular Itching Scores – Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.||Units on a Scale||Standard Deviation|Mean
70190|NCT01107392|Secondary|Duration of Effect|Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points.|24 Weeks|Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis.||Weeks||95% Confidence Interval|Median
70191|NCT01107392|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.|Baseline, Weeks 6, 12 and 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure.||mL/sec||Standard Deviation|Mean
70192|NCT01107392|Secondary|Change From Baseline in the Total International Prostate Symptom Score (IPSS)|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 6, Week 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.||Score on a scale||Standard Deviation|Mean
70193|NCT01107392|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.||Score on a scale||Standard Deviation|Mean
70194|NCT01107379|Primary|Mean Intra-patient Change in Lund-Mackay CT Scan Score|"Change in Lund-Mackay CT score for paired baseline and 24 week data.~The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.||Scores on a scale||Standard Deviation|Mean
70195|NCT01107379|Secondary|Mean Number of Days to Return to Normal Activities|Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living|2 weeks|Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.||days||Standard Deviation|Mean
70196|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.|Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.|Day 0 (Day of Procedure)|||number of sinuses|Participants||Number
78043|NCT01019928|Secondary|DBP|Supine Diastolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose|||mmHg||Standard Deviation|Mean
70197|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary|Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary|Day 0 (Day of Procedure)|||number of sinuses|Participants||Number
70198|NCT01107379|Secondary|Procedure Tolerability|Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.|Day 0 (Day of Procedure)|Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.||number of participants|||Number
70199|NCT01107379|Primary|Mean Intra-patient Change in SNOT-20 Score|"Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.~The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.||Scores on a scale||Standard Deviation|Mean
70200|NCT01107353|Primary|Bioequivalence Determined by Statistical Comparison Cmax|Blood samples were collected pre-dose and at intervals over 120 hours after each dose|33 Days|||ng/mL||Standard Deviation|Mean
70201|NCT01107197|Secondary|the Percentage of Change in Area|the reduction in ulcer area (%) observed at 4 weeks|4 weeks of nutritional support (baseline and week 4)|||percent change||Inter-Quartile Range|Median
70202|NCT01107197|Secondary|Dressings|The number of dressings used throughout the intervention period|8 weeks of nutritional support (baseline and week 8)|||dressings||Standard Deviation|Mean
70203|NCT01107197|Secondary|Cost-effectiveness|Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active – control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy).|8 weeks of nutritional support (baseline and week 8)|||Euros||Standard Deviation|Mean
70204|NCT01107197|Secondary|Incidence of Infections|defined as local (ulcer)|8 weeks of nutritional support (baseline and week 8)|||participants|||Number
70205|NCT01107197|Secondary|Rate of Healing|complete healing|8 weeks of nutritional support (baseline and week 8)|||participants|||Number
70206|NCT01107197|Secondary|Rate of Healing|reduction in ulcer area >=40%|8 weeks of nutritional support (baseline and week 8)|||participants|||Number
70207|NCT01107197|Primary|Rate of Healing|healing is defined as reduction in ulcer area (the percentage of change)|8 weeks of nutritional support (baseline and week 8)|||percent change||Standard Deviation|Mean
70208|NCT01106976|Primary|AChE PET Neuroimaging|AChE PMP PET hydrolysis rate outcome measure. AChE [11C]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.|4 yr|Parkinson disease.||1/min||Standard Deviation|Mean
70209|NCT01106950|Secondary|Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion|Association between in vivo natural killer (NK) cell expansion and complete response without platelet recovery (CRp) with donor killer immunoglobulin-like (KIR) genotype and Treg depletion. In vivo donor NK cell expansion was correlated with regulatory T-cell (Treg) depletion as detected on flow cytometry.|Day 14|||Percentage of patients|||Number
70210|NCT01106950|Secondary|Number of Patients With Treatment-Related Death|Number of patients who died within the first 100 days of treatment due to toxicity.|Day 100|||Percentage of patients|||Number
70211|NCT01106950|Secondary|Percent of Patients With Incidence of Relapse|Number of patients who have had a relapse(the return of disease after its apparent recovery/cessation) after obtaining a complete remission of their disease.|Month 6|||Percentage of patients|||Number
70212|NCT01106950|Secondary|Percent of Patients With Disease Free Survival|Number of patients alive and disease free at 6 months. The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.|Month 6|||Percentage of patients|||Number
70213|NCT01106950|Secondary|Percent of Patients With Complete Remission of Disease|Disease response was defined as complete remission (disease response) by morphologic criteria including <5% blasts in a moderately cellular or cellular marrow. Complete remission was also correlated with NK cell expansion in vivo, IL-15 levels and donor/recipient KIR B genotyping, and Treg depletion.|At least 4 weeks after last dose (28 days)|||Percentage of patients|||Number
70214|NCT01106950|Primary|Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion|The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/ul in the patient's peripheral blood 14 days after infusion.|Day 14|||Percentage of patients|||Number
70215|NCT01106911|Primary|Number of Participants Without Cancer Who Were Recalled|Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.|upon recruitment/enrollment phase completion|Includes only participants who were not diagnosed as having a breast malignancy.||participants|||Number
70283|NCT01106534|Primary|Incidence of ARC Definite or Probable ST||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
78044|NCT01019928|Secondary|SBP|Supine Systolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose|||mmHg||Standard Deviation|Mean
70216|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population||proportion|||Number
70217|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 3.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 3.5 cm and <= -3.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 3.5 cm, and an improved performance is when the difference of SDLP < -3.5 cm.|3-9 hours post dose|Intent to treat population||participants|||Number
70218|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population||proportion|||Number
70219|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.0 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.0 cm and <= -2.0 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.0 cm, and an improved performance is when the difference of SDLP < -2.0 cm.|3-9 hours post dose|Intent to treat population||participants|||Number
70220|NCT01106859|Primary|Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population||proportion|||Number
70221|NCT01106859|Primary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car’s roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.5 cm and <= -2.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.5 cm, and an improved performance is when the difference of SDLP < -2.5 cm.|3-9 hours post dose|Intent to treat population||participants|||Number
70222|NCT01106859|Secondary|Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)|Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness (summarized as 'unrelated' and 'related') to study treatment. Also included are counts of participants with serious AEs, AEs leading to discontinuation of study treatment, and deaths.|Day 1 -6 weeks|Safety population (participants who were randomized and received at least one dose of study drug)||participants|||Number
70223|NCT01106859|Secondary|Mean Standard Deviation of Speed (SDS) in the Highway Drive Test|Mean standard deviation of speed (SDS) is a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed are recorded and analyzed.|3-9 hours post dose|Intent to treat population. In one Zopiclone case, the velocity of the car was not recorded due to technical problems, and therefore SDS could not be calculated in this drive.||kilometers/hour||Standard Error|Least Squares Mean
70224|NCT01106859|Secondary|Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test|Standard deviation of lateral position (SDLP) in a highway-driving lane is a surrogate measure for driving performance. It measures the driver's ability to stay in a constant position within the driving lane. Variations in the lateral position are recorded and analyzed.|3-9 hours post dose|Intent to treat population||centimeters||Standard Error|Least Squares Mean
70225|NCT01106846|Primary|Quality of Recovery Score Post Operative at 24 Hours|Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.|24 hours post operative|||units on scale||Standard Deviation|Mean
70226|NCT01106690|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
78045|NCT01019928|Secondary|Tmax|Time of maximum plasma concentration|0 to 4 hours post dose|||hours||Full Range|Median
70227|NCT01106690|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70228|NCT01106690|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
70229|NCT01106690|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70230|NCT01106690|Secondary|Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26|HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||HOMA2-%B||Standard Error|Least Squares Mean
70231|NCT01106690|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
70232|NCT01106690|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
70233|NCT01106690|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
70234|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70235|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70236|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
70237|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70238|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
70239|NCT01106677|Secondary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
70240|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70241|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70242|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
70243|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70244|NCT01106677|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
70245|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
70246|NCT01106677|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
70247|NCT01106677|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
70248|NCT01106651|Secondary|Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70249|NCT01106651|Secondary|Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70250|NCT01106651|Secondary|Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70251|NCT01106651|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70252|NCT01106651|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70253|NCT01106651|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70254|NCT01106651|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
70255|NCT01106651|Secondary|Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
78046|NCT01019928|Secondary|Cmax|Maximum plasma concentration|0 to 4 hours post dose|||nmol/L||95% Confidence Interval|Geometric Mean
70256|NCT01106651|Secondary|Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
70257|NCT01106651|Secondary|Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||kg||Standard Error|Least Squares Mean
70258|NCT01106651|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70259|NCT01106651|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
70260|NCT01106651|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
70261|NCT01106651|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
70262|NCT01106625|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70263|NCT01106625|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70264|NCT01106625|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mmHg||Standard Error|Least Squares Mean
70284|NCT01106534|Primary|Incidence of Composite of All Death, MI and Stroke (Defined as MACE)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70265|NCT01106625|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
70266|NCT01106625|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
70267|NCT01106625|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
70268|NCT01106625|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
70269|NCT01106586|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT analysis set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).||percentage of participants|||Number
70270|NCT01106586|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis.||cells/µL||Standard Deviation|Mean
70271|NCT01106586|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT analysis set||percentage of participants|||Number
70272|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 modified intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.||percentage of participants|||Number
70273|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set||percentage of participants|||Number
70274|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set||percentage of participants|||Number
70275|NCT01106586|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|ITT analysis set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
70276|NCT01106534|Secondary|Major Bleeding for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70277|NCT01106534|Secondary|ST for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70278|NCT01106534|Secondary|MACE for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70279|NCT01106534|Secondary|Major Bleeding for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70280|NCT01106534|Secondary|ST for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70281|NCT01106534|Secondary|MACE for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.|||||
70285|NCT01106430|Secondary|Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1|UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||participants|||Number
70286|NCT01106430|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||participants|||Number
70287|NCT01106430|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
70288|NCT01106430|Secondary|Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
70289|NCT01106430|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
70290|NCT01106430|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
70291|NCT01106430|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.||percentage of participants|||Number
70292|NCT01106430|Primary|Time to First Response|Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. One subject was randomized to receive Strattera, but actually received Lisdexamfetamine Dimesylate. For all efficacy analyses this subject is included in the Strattera arm per the intention to treat principle.||Days||95% Confidence Interval|Median
70293|NCT01106404|Secondary|NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant|The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning “No pain” and 10 meaning “Pain as bad as you can imagine,” accompanied by the instructions “Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours.” The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits.|Baseline, 10 weeks and 16 weeks post-implant|69 of the 76 subjects completed pain diary for both baseline and 10 weeks. 69 of the 76 subjects completed pain diary for both baseline and 16 weeks. Since 2 datasets had 2 different pairs of data due to different subjects who completed the pain diary, baseline NPRS in two analyses varied slightly.||units on a scale||Standard Deviation|Mean
70294|NCT01106404|Secondary|Manual Adjustments Presented as Button Presses|The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared.|Baseline, 10 weeks and 16 weeks post-implant|Subjects with manual adjustments data from patient programmer were included in the analysis.||Button presses per day||Standard Deviation|Mean
70295|NCT01106404|Secondary|Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming|The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded “much worse pain relief with AdaptiveStim” or “somewhat worse pain relief with AdaptiveStim”.|16 weeks post-implant|A total of 71 subjects with completed data were included in this analysis.||percentage of participants|||Number
70755|NCT01100944|Secondary|Disease Control Rate (DCR)|DCR is defined as stable disease (SD) + partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST).|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||percentage of participants||95% Confidence Interval|Number
70296|NCT01106404|Primary|Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm|After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.|16 weeks post-implant|"The ITT analysis included 74 subjects; 2 randomized subjects, who discontinued early due to infections, were excluded per protocol. The 3 other subjects who discontinued early were included in ITT analysis and imputed as failures for the primary objective.~No imputation method was used for 71 subjects included in the completed case analysis."||percentage of participants|||Number
70297|NCT01106391|Primary|Rate of Primary Safety Endpoint Within 1 Month Post-procedure.|Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.|One month follow-up|The analysis population consists of subjects with complete core laboratory data at 1 month.||participants|||Number
70298|NCT01106391|Primary|Rate of Technical Success Through the One Month Follow up.|Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.|From procedure to one month follow up|All enrolled subjects||participants|||Number
70299|NCT01106352|Other Pre-specified|Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain|The subject completed the full BPI (short form) paper questionnaire, and clinical staff completed the analgesic log. The test consists of 10 questions addressing severity, location, chronicity, and amount of relief. In question 3, subjects with pain are asked to evaluate the severity of pain at worst in the past 24 hours in a 0 to 10 scale, with 0 indicating no pain, and 10 indicating the worst pain.|From start of study treatment until 12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||Participants|||Number
70300|NCT01106352|Other Pre-specified|Overall Survival Rate|The overall survival (OS) time in days was calculated as number of days since the day of first dose of study medication until the date of death.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
70301|NCT01106352|Other Pre-specified|Progression Free Survival (PFS) End Point|PFS defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (radiological or clinical, whichever was earlier) or death (if death occurred before progression was documented). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
70302|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Clinical or Radiographic Progression|"Time to first radiologic or clinical progression is determined by one of the following:~For soft tissue lesions, the determination is based on Response Evaluation Criteria in Solid Tumors 1.1.~For bone disease, the determination is based on Prostate Cancer Working Cohort 2 (PCWG2) definitions, which require the appearance of at least 2 new lesions with a confirmatory bone scan at least 6 or more weeks later. For clinical progression, the investigators followed the recommendations of the PCWG25 and used their clinical judgment to determine clinical progression."|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
70303|NCT01106352|Other Pre-specified|Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85|CTCs were measured to follow the evolution of the level of CTCs after treatment.|Baseline, Day 85, expanded safety cohort|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||Percent Change||Standard Deviation|Mean
70304|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression|Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 1 week apart.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||days||95% Confidence Interval|Median
70305|NCT01106352|Other Pre-specified|Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers|Weighted mean area under the curve for the below bone turnover biomarkers were evaluated, ICTP = pyridinoline cross-linked carboxyterminal telopeptide P1NP = N-terminal peptide of procollagen type 1 uCTX-1 = urine C-telopeptide 1|From start of study treatment to 6 weeks after study treatment (maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.||mcg/L||Standard Deviation|Mean
71193|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
70306|NCT01106352|Primary|Number of Subjects With Signs of Long-Term Radiation Toxicity|Long-term radiation toxicity included incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukemia, myelodysplastic syndrome, and aplastic anemia).|From start of study treatment upto 12 months|Only participants who received treatment were assessed||Participants|||Number
70307|NCT01106352|Primary|Number of Subjects With Physical Examination During the Treatment Period|Any physical examination finding that was classified by the investigator as a clinically significant change (compared with previous examination) was considered an AE, documented on the eCRF, and followed until the outcome was known. The below physical examination findings were recorded and reported. GDASC = General disorders and administration site conditions MND = Metabolism and nutrition disorders SSTD= Skin and subcutaneous tissue disorders MCTD = Musculoskeletal and connective tissue disorders IPPC = Injury, poisoning and procedural complications RTMD = Respiratory, thoracic and mediastinal disorders NBMU = Neoplasms benign, malignant and unspecified (include cysts and polyps) In the below table.|From start of study treatment to 6 weeks after study treatment (i.e., maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||Participants|||Number
70308|NCT01106352|Primary|Changes From Baseline in Weight During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||kilogram(s)||Standard Deviation|Mean
70309|NCT01106352|Primary|Changes From Baseline in Heart Rate During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||beats per min||Standard Deviation|Mean
70310|NCT01106352|Primary|Changes From Baseline in Respiratory Rate During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||breaths/min||Standard Deviation|Mean
70311|NCT01106352|Primary|Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed||millimeters of mercury (mmHg)||Standard Deviation|Mean
70312|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||tetra per liter (TI/L)||Standard Deviation|Mean
70313|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||giga per liter (GI/L)||Standard Deviation|Mean
70314|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||millimole(s)/liter||Standard Deviation|Mean
70315|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||micromole(s)/litre||Standard Deviation|Mean
70316|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed||units per liter (U/L)||Standard Deviation|Mean
70317|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only randomized participants who have this outcome measure tested were assessed||gram per liter (G/L)||Standard Deviation|Mean
70318|NCT01106352|Primary|Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in patient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study treatment to 6 weeks after study treatment (that is maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) and 8 weeks for serious AEs|Only participants who received treatment were assessed||Participants|||Number
70803|NCT01100437|Other Pre-specified|Time to First Occurrence of a COWS Score ≥ 13 for Each Treatment During the Treatment Phase|Average time to first occurrence of a COWS score ≥ 13|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hr post-dose and UA|ITT; Subset of participants with COWS >= 13||h||Standard Error|Mean
70319|NCT01106352|Primary|Number of Subjects With Dose-Limiting Toxicities – Dose Escalation Part|DLT was defined as - Absolute neutrophil count grade greater than or equal to (>=) 4 (Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0: less than [<] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade >= 4 (CTCAE, v4.0: < 25× 109/L) lasting longer than 7 days. Diarrhea Grade >= 3 (CTAE, v4.0: increase of >= 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care in activities of daily living) in spite of optimal use of antidiarrheal medication. Vomiting or constipation Grade >= 4 (CTCAE, v4.0: life-threatening consequences; urgent intervention indicated). Febrile neutropenia Grade >= 3 (CTCAE, v4.0).|From randomization until 6 weeks post-injection in all dose cohort of dose-escalation part|||Participants|||Number
70320|NCT01106326|Secondary|Additional Asthma Morbidity Measures|We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments.|2 month, 4 month, final follow-up assessments||||||
70321|NCT01106326|Primary|Number of Symptom-free Days Over Two Weeks|We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.|2 and 4 month follow-up assessments|Analysis conducted per protocol.||Days||Standard Deviation|Mean
70322|NCT01106287|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Only treatment-emergent adverse events were examined for this outcome measure.|Up to 6 weeks after the first dose of study drug|All participants receiving any dose of MK-0941 of placebo.||participants|||Number
70323|NCT01106287|Primary|Number of Participants Who Experienced One or More Adverse Events During the Study||Up to 30 days after the last dose of study drug|All participants receiving any dose of MK-0941 or placebo||participants|||Number
70324|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Time to Maximum Observed Plasma Concentration (Tmax).|Pharmacokinetic profile of eribulin mesylate (tmax).|Days 1 and 8|Pharmacokinetic Population||hours||Full Range|Median
70325|NCT01106248|Secondary|To Further Explore the Safety and Tolerability of Eribulin Mesylate When Administered on Days 1 and 8 of a 21-day Cycle in Patients With Solid Tumors.||21 day cycle||||||
70326|NCT01106248|Secondary|To Assess Best Overall Response Using RECIST Criteria in Patients With Measurable Disease.||21 day cycle||||||
70327|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Observed Maximal Plasma Concentration (Cmax)|Pharmacokinetic profile of eribulin mesylate (Cmax).|Days 1 and 8|Pharmacokinetic Population||ng/mL||Standard Deviation|Mean
70328|NCT01106248|Primary|Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing.|The primary endpoint is mean time-matched, baseline corrected QTcF at any time point postdosing. This was to determine the effect of eribulin on cardiac repolarization as measured by QT/QTc interval.|48 hours postdose after Day 1 and after Day 8|Per Protocol Population||msec||Standard Deviation|Mean
70329|NCT01106157|Secondary|Change in White Blood Count (WBC) From Baseline to 12 Months|Change in WBC over 12 months|Change from baseline to 12 months|||Change in percentage of WBC||Standard Deviation|Mean
70330|NCT01106157|Secondary|Percentage of Neutrophils|Change in Neutrophil Count over 12 months|Change from baseline to 12 months|||Percentage of neutrophils||Standard Deviation|Mean
70331|NCT01106157|Secondary|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) From Baseline to 12 Months|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) over 12 months|Change from baseline to 12 months|||nmol/L||Standard Deviation|Mean
70332|NCT01106157|Secondary|Change in Insulinoma Associated 2 Autoantibodies (IA-2A) From Baseline to 12 Months|Change in Insulinoma Associated 2 Autoantibodies (IA-2A)|Change from baseline to 12 months|||nmol/L||Standard Deviation|Mean
70333|NCT01106157|Secondary|Change in Insulin Autoantibodies (IAA) From Baseline to 12 Months|Change in Insulin Autoantibodies (IAA) over 12 months|Change from baseline to 12 months|||Units/mL||Standard Deviation|Mean
70334|NCT01106157|Secondary|Change in Glutamic Acid Decarboxylase Antibodies (GADA) From Baseline to 12 Months|Change in Glutamic Acid Decarboxylase Antibodies (GADA) over 12 months|Change from baseline to 12 months|||nmol/L||Standard Deviation|Mean
70335|NCT01106157|Secondary|Change in Insulin Requirements, Baseline to 12 Months|Change in Insulin Requirements, baseline to 12 months|Change from baseline to 12 months|Insulin use data was not provided by all subjects resulting in sampling for analysis that was smaller than the cohort for the entire study.||units/kg/day||Standard Deviation|Mean
70336|NCT01106157|Secondary|A1c|Change in A1c baseline to 12 months|Change in baseline to 12 months|||% change||Standard Deviation|Mean
70337|NCT01106157|Secondary|Percent Change in Regulatory T Cells (Treg) Baseline to 12 Months|Change in regulatory T cells (Treg) baseline to 12 months|Change in Baseline to 12 months|||percentage change||Standard Deviation|Mean
70338|NCT01106157|Primary|Change in Metabolic Function Baseline to 12 Months.|Area Under Curve (AUC) C-peptide production. Subjects underwent a 2 hour mixed meal tolerance test (MMTT) using a 6ml/kg load of boost to stimulate insulin production. Samples were collected at baseline, 10 minutes, 20 minutes, 30 minutes, 60 minutes, 90 minutes, and 120 minutes. AUC was then calculated. Subjects repeated the MMTT at baseline, 3, 6, 9, and 12 months following ATG/GCSF or placebo. The primary outcome for the study was the change over 12 months in AUC C-peptide (1 year - baseline) for those who received ATG/GCSF versus the change in AUC C-peptide (1 year - baseline) for those who received placebo|Baseline and 12 months|||nmol/L/min||Standard Deviation|Mean
70339|NCT01106040|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
70769|NCT01100853|Secondary|Amphetamine Craving Scale|The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.|24 weeks|||VAS Score||Standard Deviation|Mean
70340|NCT01106040|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
70341|NCT01106014|Secondary|Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC)||Week 26|Full analysis set. Patients with WHO FC IV at baseline were excluded from this analysis as they could not shift to a worse category||Percentage of patients|||Number
70342|NCT01106014|Secondary|Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough|The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. If the patient was used to taking bronchodilators before a walk, he/she was given them 5 to 30 min before the test. Also if the patient was on chronic oxygen therapy, oxygen was given at their standard rate during the test. Absolute change from baseline to Week 26 in 6MWD was measured at trough, i.e., either on the next day after the last study drug administration or at least 12 hours after study drug administration if on the same day.|Week 26|Full analysis set||Meters||Full Range|Median
70343|NCT01106014|Primary|Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake|"Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points).~Morbidity event was defined as any of the following events confirmed by the Critical Event committee:~Hospitalization for worsening of pulmonary arterial hypertension (PAH),~Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy,~Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH,~Disease progression which was defined by a decrease in 6-minute walk distance from baseline (>=15%, confirmed by a 2nd test on a different day) combined with worsening of WHO FC for patients belonging to WHO FC II/III at baseline, or combined with the need for additional PAH-specific therapy for patients belonging to WHO FC III/IV at baseline.~Note: The number of patients at risk decreased over time but this cannot be captured below"|Up to 7 days after end of double-blind treatment (maximum: 4.3 years)|The primary endpoint was analyzed using the full analysis set, which includes all randomized patients evaluated according to the study drug to which they have been randomized (intention-to treat analysis set).||Percentage of patients free of events||95% Confidence Interval|Number
70344|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]|Subjective NRS response for each participant for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
70345|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]|Subjective NRS response for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on tibio-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
70346|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]|Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
70347|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]|Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on tibio-femoral joint. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
70348|NCT01105936|Secondary|Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]|Subjective NRS response for each participant was calculated as difference of pre-treatment NRS pain assessment before stimulus and post-treatment NRS pain assessment before stimulus. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose before stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Score on a Scale||Standard Deviation|Mean
70385|NCT01105091|Primary|Blood Pressure - Baseline and Day 28|Blood pressure (systolic and diastolic) were measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Blood Pressure was assessed at baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||mm Hg||Full Range|Median
70349|NCT01105936|Secondary|BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution|Baseline to 2-5 hours post last dose administration|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Z-score||Standard Deviation|Mean
70350|NCT01105936|Primary|Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.|Baseline to 2-5 hours post last dose administration|Intention-to-treat (ITT) population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.||Z-score||Standard Deviation|Mean
70351|NCT01105767|Primary|Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI||At the end of the 20 month study|||participants|||Number
70352|NCT01105767|Primary|Incidence of Skin and Soft Tissue Infection (SSTI)||At the end of the 20 month study|||participants|||Number
70353|NCT01105754|Secondary|Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.|The number of children who received guideline-based asthma care (eg: inhaled steroid prescription, counseling for triggers, counseling for adherence) at the intervention visit based on parent interview at the 2-week follow-up and medical record review.|2 week follow-up, and medical record review|||participants|||Number
70354|NCT01105754|Primary|Symptom Free Days|The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.|2 month follow-up assessment|||Days||Standard Deviation|Mean
70355|NCT01105702|Secondary|Number of Patients With Grade 3 or 4 Adverse Events|Adverse events evaluated per CTCAE 3|The whole time while on treatment and 30 days after the treatment|all the patients with treatment||participants|||Number
70356|NCT01105702|Secondary|Median Overall Survival (OS)|OS defined as time from diagnosis to most recent follow up or death.|Up to 50 months|intent-to-treat population||months||95% Confidence Interval|Median
70357|NCT01105702|Primary|Median Progression-Free Survival (PFS)|PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al).|Up to 50 months|Intent-to-treat population||months||95% Confidence Interval|Median
70358|NCT01105533|Other Pre-specified|Effect of Food on Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 29 (fasted state), Day 30 (fed state) for once daily groups, pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 29 Day 29 (fasted state), Day 30 (fed state) for twice daily groups|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, food effect on AUC (0-24) was not assessed.|||||
70359|NCT01105533|Secondary|Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25|Biomarkers included soluble plasma proteins associated with angiogenesis (vascular endothelial growth factor [VEGF], soluble vascular endothelial growth factor-2 receptor [sVEGFR2], soluble vascular endothelial growth factor-3 receptor [sVEGFR3], soluble beta type platelet-derived growth factor [sPDGFR beta]) and tumor proliferation (soluble stem-cell factor receptor [sKIT])|Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25|Results are not reported as the data were not statistically summarized but available in individual participant listing.|||||
70360|NCT01105533|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions and no appearance of new lesions. Confirmed PR defined as at least 30 percent decrease in sum of the longest dimensions (LD) of the target lesions, taking as a reference the baseline sum LD, without progression of non-target lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline, every 8 weeks up to Cycle 25 (Week 100)|Full Analysis set included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
70361|NCT01105533|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, CL was not calculated.|||||
70770|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines)||24 Weeks|Urine drug screens negative amphetamine||Urine Drug Screen|||Number
70771|NCT01100762|Primary|First Step Velocity|First step velocity was measured in meters per second|Data collection occurred before and immediately after each training session|||m/sec||Standard Deviation|Mean
70362|NCT01105533|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Vss was not calculated.|||||
70363|NCT01105533|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0 - ∞) was not calculated.|||||
70364|NCT01105533|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0-24) was not calculated.|||||
70365|NCT01105533|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, t1/2 was not calculated.|||||
70366|NCT01105533|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Cmax was not calculated.|||||
70367|NCT01105533|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg twice daily|||Number
70368|NCT01105533|Primary|Maximum Administered Dose (MAD)|MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg once daily|||Number
70369|NCT01105533|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.||mg once daily|||Number
70370|NCT01105533|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Baseline up to Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
70478|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
70371|NCT01105377|Secondary|Time to Progression|Time to disease progression (TTP) is defined as the time from the start of treatment to the earliest of the date documenting disease progression or most recent assessment for patients having no progression. The distribution of TTP is estimated using the method of Kaplan-Meier.|From the start of treatment to the earliest of the date documenting disease progression, assessed up to 3 years|Analysis for this endpoint was “per protocol” and two participants were excluded. One participant in Cohort I was ineligible and one participant in Cohort II refused to start their 1st cycle of study treatment (ie, cancelled). Therefore, 23 participants in Cohort I and 22 participants in Cohort II were analyzed for this secondary endpoint.||months||95% Confidence Interval|Median
70372|NCT01105377|Primary|Confirmed Tumor Response|Each evaluable patient is classified as having a confirmed tumor response if they have either a complete response (CR) or partial response (PR) lasts at least 4 weeks. Tumor response is measured by using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). A CR is defined as a disappearance of all target lesions, and each target lymph node must have reduction in short axis to <1.0 cm. A PR is defined as a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation, compared to pre-treatment measurements. The confirmed response rate is calculated as the number of confirmed CR+PR, divided by the total number of evaluable patients, with 95% confidence intervals estimated using the approach of Duffy and Santner.|At 6 month evaluation|Analysis was performed “per protocol” using only Cohort II participants, except those deemed ineligible, cancelled, or in major treatment violation during cycle 1. One of the 23 Cohort II participants was excluded in the analysis due to cancelling before initiating treatment.||percentage of participants||95% Confidence Interval|Number
70373|NCT01105247|Secondary|Percentage of Participants Achieving Response|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).|||Percentage of Participants||95% Confidence Interval|Number
70374|NCT01105247|Secondary|Progression Free Survival Rate at 24 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).|||Percentage of Participants||95% Confidence Interval|Number
70375|NCT01105247|Secondary|Food Effect Cohort Assessments|Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.|Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.|Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison.||||90% Confidence Interval|Number
70376|NCT01105247|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AEs.|From first dose to within 30 days of last dose of PCI-32765|||Participants|||Number
70377|NCT01105130|Secondary|Quality of Life|Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate (FACT_P) questionnaire. The FACT questionnaire is comprised of four subscales – social, emotional, functional, and physical. Each subscale is obtained by summing over 6-7 items, each of which is coded on a 0 to 4 scale. Negatively worded questions are reverse scored and higher scores for each subscale indicate better HRQOL. The social, functional, and physical subscales range from 0 to 28 while the emotional subscale ranges from 0 to 24. The overall score (FACT-G) is the sum over the four subscales and ranges from 0 to 108. Patients also completed 12 questions related to prostate cancer, and the prostate subscale score is the sum of those responses (with some items reverse scored). Scores range from 0 to 48, and as with the other FACT subscales higher scores indicate better HRQOL. FACT-P is the sum of FACT-G and the prostate subscale. This questionnaire was added half-way through the study.|8 weeks|All participants who completed the FACT_P at any time.||units on a scale||Standard Error|Least Squares Mean
70378|NCT01105130|Secondary|Adherence|Adherence is the percentage of prescribed pills taken by the participants|8 weeks|Participants who returned pill diaries.||percentage of prescribed pills||Full Range|Mean
70379|NCT01105130|Secondary|Retention|Retention is the percentage of participants who complete the 8 week visit.|8 weeks|All randomized participants||percentage of participants||95% Confidence Interval|Number
70380|NCT01105130|Primary|Erectile Function|The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.|8 weeks|All participants providing data at any time.||units on a scale||Standard Error|Least Squares Mean
70381|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population||participants|||Number
70382|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population||participants|||Number
70383|NCT01105091|Primary|Body Weight - Baseline and Day 28|Body weight was measured both at baseline and day 28.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||kg||Full Range|Median
70384|NCT01105091|Primary|Heart Rate - Baseline and Day 28|Heart rate was measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Heart Rate was assessed at Baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||Beats per minute||Full Range|Median
70854|NCT01100073|Secondary|Final Dose Distribution|Final Mirapexin® dose distribution at the end of study|Enter Week 0 to weeks 9-16 (Visit 3)|Total patients. Number of participants analysed differs for each outcome measure because not all evaluations were performed / documented on every patient.||milligrams of Mirapexin® (salt)||Full Range|Median
70386|NCT01105091|Primary|Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28|Central venous blood oxygen saturation assessment was performed only in specific centers. Measurements for ScVO2 were performed during the inpatient hospitalization period on Day 1 (prior to drug initiation) and on Day 28 (EOT). Samples for ScVO2 were obtained by aspirating blood from the indwelling central venous catheter. After the sample had been drawn, the catheter was primed with study drug in order to refill the lumen to avoid interruption in treatment and sudden decompensation.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||percentage oxygen saturation||Full Range|Median
70387|NCT01105091|Primary|Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|From baseline to 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||participants|||Number
70388|NCT01105091|Primary|Six-minute Walk Distance (6MWD) - Baseline and Day 28|The 6-minute walk test (6MWT) was to be performed prior to initiating study treatment either during the screening visit or on Day 1 prior to drug initiation, and Day 28 (End of treatment (EOT)). This assessment is a non-encouraged test that measures the distance walked for a duration of 6 minutes. The 6MWD was recorded in the Case Report Form (CRF).|Baseline and 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.||meters||Full Range|Median
70389|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
70390|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
70391|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
70392|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.||(pg/ml)/(ng/kg/min)||Full Range|Median
70393|NCT01105065|Secondary|Frequency Doubling Perimetry|Frequency doubling perimetry was measured pre- and post treatment with brimonidine for 8 weeks.We used the full-threshold N-30 protocol to determine the visual field mean deviation, pattern standard deviation, and test duration in the eye that had hemodynamic testing. The results that are reported below are the mean deviation values recorded as part of the frequency doubling perimetry as these are the most significant.|8 weeks|||dB||Standard Deviation|Mean
70394|NCT01105065|Primary|Presence of Retinal Blood Flow Autoregulation|We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%.|8 weeks|||participants|||Number
70395|NCT01104870|Secondary|Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 12|The N-terminal pro-BNP (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 12.|Baseline and Week 12|All subjects with Baseline and Week 12 NT-proBNP values recorded were included in the analysis.||pg/mL||Standard Deviation|Mean
70396|NCT01104870|Secondary|Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 12|The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. Only participants who experienced a change in WHO functional classification from Baseline to Week 12 are described by class change below; all other participants maintained their Baseline WHO functional classification at Week 12.|Change from Baseline at Week 12|All subjects with Baseline and Week 12 WHO functional classifications recorded were included in the analysis.||participants|||Number
70492|NCT01104376|Primary|Measure Efavirenz Clearance|Effect of steady-state voriconazole on efavirenz Clearance in healthy volunteers (n=61) administered a single 100 mg oral dose of efavirenz at baseline (control phase) and after treatment with voriconazole to steady-state.|Baseline, 30 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after efavirenz|||ml/min/kg||Standard Deviation|Mean
70397|NCT01104870|Secondary|Change in PH Symptoms From Baseline to Week 12|Symptoms of PH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed and severity grade values (i.e., 0, 1, 2 or 3) for each symptom were assigned for subjects. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Median change in symptom severity from Baseline to Week 12 is described.|Change from Baseline at 12 Weeks|All subjects with Baseline and Week 12 values recorded for symptoms of PH were included in the analysis.||units on a scale||Inter-Quartile Range|Median
70398|NCT01104870|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 12|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and Week 12|All subjects with Baseline and Week 12 Borg dyspnea scores recorded were included in the analysis.||score||Inter-Quartile Range|Median
70399|NCT01104870|Secondary|Change in 6-minute Walk Distance (6MWD) From Baseline to Week 12|The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). Subjects were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and Week 12|All subjects with Baseline and Week 12 6MWD values recorded were included in the analysis.||meters||Standard Deviation|Mean
70400|NCT01104870|Secondary|Change in Cardiac Index (CI) From Baseline to Week 12|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 CI values recorded were included in the analysis.||L/min/m^2||Standard Deviation|Mean
70401|NCT01104870|Secondary|Change in Mean Pulmonary Artery Pressure (PAPm) From Baseline to Week 12|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. The PAPm values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 PAPm values recorded were included in the analysis.||mmHg||Standard Deviation|Mean
70402|NCT01104870|Primary|Change in Peak Total Pulmonary Resistance Index (TPRI) During Exercise From Baseline to Week 12|"The effects of 12-week treatment with different doses of UT-15C on peak TPRI during exercise will be evaluated by comparing the change from Baseline to Week 12 at peak wattage on a pairwise basis between treatment groups.~The primary measure of efficacy was the change from Baseline to Week 12 in peak TPRI during exercise assessed 3 to 6 hours after the subject’s morning dose of UT-15C to obtain measurements at peak concentrations of treprostinil. The equation used to determine the Total Pulmonary Resistance Index (TPRI) (mmHg/[L/min/m^2]) is Mean Pulmonary Artery Pressure (PAPm)/ Cardiac Index (CI)."|Baseline and Week 12|All subjects with Baseline and Week 12 TPRI values recorded were included in the analysis.||mmHg/(L/min/m^2)||Standard Deviation|Mean
70403|NCT01104701|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance (PCI): triacylglycerol lipase high values were > 3* upper limit of normal (ULN); creatinine high values in males >1.6 mg/dL, females >1.4 mg/dL; gamma glutamyl transferase (GGT) high value >3* ULN; bilirubin high value > 2 mg/dL; Urate high values > 10 (males), >8 (females) mg/dL; potassium low value < 3 milliequivalents per liter (mEq/L), high value >5.5 mEq/L; calcium low value < 8 mg/dL and high value > 11 mg/dL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance (values could be either low or high) are presented for Weeks 6 - Week 24 or early termination. Note: those tests with no values meeting the PCI criteria, ie, 0 values observed across all treatment arms, are not presented.|Day 1 to Study Termination (Week24) or early termination|All participants who were randomized and received at least one dose of study drug were analyzed in the intent to treat (ITT) population. n= all participants who received at least one dose of study drug and had available laboratory measurements.||laboratory values|||Number
70404|NCT01104701|Secondary|Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance are the following: Hematocrit values for males less than (<) 36%, females < 30%; hemoglobin for males <12 grams per deciliter (g/dL), females < 10 g/dL; low platelet values <75,000/micro liter (µL), high values greater than (>) 500,000 µL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance presented for Weeks 6 - Week 24 or early termination.|Day 1 to study termination (24 weeks) or early termination|n= all participants who received at least one dose of study drug and had available laboratory measurements.||laboratory values|||Number
70405|NCT01104701|Secondary|Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1.|Day 1 to Study Termination (24 weeks) or early termination|n=all participants who received at least one dose of study drug and had available titer.||participants|||Number
70493|NCT01104285|Primary|Total Days of Mechanical Ventilatory Support||days|||days||Standard Deviation|Mean
70772|NCT01100762|Primary|First Step Length|First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.|Data collection occurred before and immediately after each training session|||m||Standard Deviation|Mean
70406|NCT01104701|Secondary|Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population|"AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Injection site related adverse events were defined as the adverse events with 'injection site' phrase in preferred term excluding 'injection site nodule'. The following events were Injection Site Reaction AEs: erythema, hematoma, hemorrhage, site pain, site papule, site pruritus, site warmth.~Participants receiving study drug monthly received 5 injections with last injection at Week 16; Participants receiving study drug weekly received 20 injections with last injection at Week 19."|Day 1 through study termination (Week 24) or early termination.|All participants who received at least one dose of study drug were analyzed in the ITT population.||participants|||Number
70407|NCT01104701|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All participants who received at least one dose of study drug were included in the ITT analysis. Treatment-emergent (TE) adverse events were defined as those with onset at or after initiation of study medication on Day 1 through study termination or early termination.|Day 1 to Study Termination (24 Weeks) or early Termination|All participants who received at least one dose of study drug were included in the ITT analysis.||participants|||Number
70408|NCT01104701|Secondary|Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Heart rate was measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in beats per minute (bpm). The measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the ITT population.||bpm||Standard Deviation|Mean
70409|NCT01104701|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Vital signs were measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in millimeters of mercury (mmHg). The blood pressure measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the Intent to Treat (ITT) population.||mmHg||Standard Deviation|Mean
70410|NCT01104701|Secondary|Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population|All participants received an initial blood draw prior to the first dose and a single blood sample was collected at all other subsequent visits, for plasma exenatide assessments and the characterization of pharmacokinetic (PK) parameters following multiple monthly doses over the study period. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Time weighted average concentration (Cave (2016-2688 h) and Peak to Trough were measured in picograms per milliliter (pg/mL).|Day 1 to Week 20|PK Evaluable- Steady-State: from trough to trough following Week 12 through Week 16, 3 or more values.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
70411|NCT01104701|Secondary|Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population|Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.||mg/dL||Standard Error|Mean
70412|NCT01104701|Secondary|Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population|Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis. n=number of participants with measurement value.||kg||Standard Error|Mean
70413|NCT01104701|Secondary|Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population|HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were <7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value for Week 20 were included in the analysis of the evaluable population. n=number of participants with measurement value.||percentage of Participants|||Number
70414|NCT01104701|Primary|Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population|HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to 20 weeks|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.||Percent of Hemoglobin||Standard Error|Mean
70873|NCT01099761|Secondary|Percent Change in Total Lean Body Mass by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.|||percentage change in lean body mass||Standard Error|Mean
70415|NCT01104662|Secondary|Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit|"Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit:~Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication.~Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit.~Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator."|Baseline through TOC/Safety Visit|Participants who received at least 1 dose of study drug and had at least 1 Gram-positive baseline infecting pathogen for cSSSI participants or S. aureus bacteremia for bacteremia participants.||participants|||Number
70416|NCT01104662|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)|The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.|Baseline through EOT/ET|Participants who received at least 1 dose of study drug and had a baseline CPK value and at least 1 post-baseline CPK assessment between Day 1 post-dosing and EOT visit.||participants|||Number
70417|NCT01104636|Secondary|Level of Nicotine Dependence Measured by the Fagerstrom Test|Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence).|Baseline|The all participants’ population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.||Scores on a scale||Standard Deviation|Median
70418|NCT01104636|Primary|Percentage of Participants Who Abstained From Smoking at Week 12|The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with ‘no’ answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.|Week 12|The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.||percentage of participants||95% Confidence Interval|Number
70419|NCT01104584|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow–up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||Participants|||Number
70420|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||beats/min||Standard Deviation|Mean
70421|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, 24 hours post injection|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||mmHg||Standard Deviation|Mean
70422|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."|||||
70423|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."|||||
70424|NCT01104584|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||Kappa|Participants||Number
70425|NCT01104584|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
70494|NCT01104246|Primary|Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours|A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.|Day 28/29|Per-protocol Population was used for the analysis. PP population included subjects who completed the treatment period of the study, who did not have more than two consecutive missing data, and who did not have any major protocol deviations.||ng/dL||Standard Deviation|Mean
70426|NCT01104584|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
70427|NCT01104584|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Sensitivity Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||Kappa|Participants||Number
70428|NCT01104584|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Clinical Investigator, Participant Level|The disease state “bilateral malignant disease” was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region , the assessment of bilateral malignant disease was categorized as “No”. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as “Yes”. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease were derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on 380 participants in FAS; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.||difference in accuracy (%)||95% Confidence Interval|Mean
70429|NCT01104584|Other Pre-specified|Sensitivity of Detection of Multicentric Malignant Disease Verified by SoT, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
70430|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in specificity (%)|Participants|95% Confidence Interval|Mean
70431|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in specificity (%)|Participants|95% Confidence Interval|Mean
70432|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in specificity (%)|Participants|95% Confidence Interval|Mean
70433|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
70434|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
70505|NCT01103973|Primary|Clinical Pregnancy Rates|Presence of normal fetal heart rate and fetal size at 7 weeks gestation.|1 year|||percentage of participants|||Number
70435|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions. Difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
70436|NCT01104584|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N-FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 395 participants in FAS; evaluable for specificity were breasts with or without malignant disease verified by SoT with available assessments by the imaging modality.||specificity (%)||95% Confidence Interval|Mean
70437|NCT01104584|Other Pre-specified|Breast Level Specificity in Malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
70438|NCT01104584|Other Pre-specified|Breast Level Specificity of in Non-malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants; evaluable for specificity were breasts with no malignant disease verified by SoT for which an assessment of the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
70439|NCT01104584|Other Pre-specified|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using XRM, CMRM+XRM and UMRM+XRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were performed for a total number of 390 participants who had regions with malignant disease verified by SoT with available assessment by the imaging modality.||sensitivity (%)||95% Confidence Interval|Mean
70440|NCT01104584|Secondary|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Reader, Participant Level|The investigator and the blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1 = not confident, 2 = somewhat confident, 3 = confident, and 4 = very confident). For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||difference of scores on a scale||95% Confidence Interval|Mean
70441|NCT01104584|Secondary|Percentage Difference of Participants Whose Additional Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The evaluation was based on the 84 participants in the FAS who had at least one additional cancer region according to SoT.||difference in percentage of participants||95% Confidence Interval|Number
70442|NCT01104584|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.||difference in percentage of participants||95% Confidence Interval|Number
70443|NCT01104584|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
70453|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70444|NCT01104584|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SoT) for which a CMRM assessment was available.||specificity (%)||95% Confidence Interval|Mean
70445|NCT01104584|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).||sensitivity (%)||95% Confidence Interval|Mean
70446|NCT01104584|Primary|Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).||difference in sensitivity (%)||95% Confidence Interval|Mean
70447|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||pg/mL||Standard Deviation|Mean
70448|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||pg/mL||Standard Deviation|Mean
70449|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||pg/mL||Standard Deviation|Mean
70450|NCT01104558|Secondary|Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||picograms (pg)/ milliliter (mL)||Standard Deviation|Mean
70451|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70452|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70454|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70455|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70456|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70457|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70458|NCT01104558|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70459|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70460|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70461|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70462|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70463|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70464|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70465|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||mmHg||Standard Deviation|Mean
70544|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy|within 6 months of provider recommendation|||participants|||Number
78047|NCT01019928|Secondary|AUCt|Area under the plasma concentration curve from time zero to the last quantifiable concentration|0 to 4 hours post dose|||nmol*h/L||95% Confidence Interval|Geometric Mean
70466|NCT01104558|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||millimeters of mercury (mmHg)||Standard Deviation|Mean
70467|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
70468|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
70469|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
70470|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
70471|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
70472|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
70473|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||bpm||Standard Deviation|Mean
70474|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Beats per minute (bpm)||Standard Deviation|Mean
70475|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
70476|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
70477|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
70479|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
70480|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
70481|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Meter||Standard Deviation|Mean
70482|NCT01104558|Secondary|Duration of Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Participant analyzed included 1 participant from the efficacy ITT population who was hospitalized once due to heart failure.||Days|||Number
70483|NCT01104558|Secondary|Number of Participants With Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration.||Participants|||Number
70484|NCT01104558|Primary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT)||Baseline and Week 26 (or EOT)|"Efficacy intention to treat (ITT) population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."||Percent LVEF||Standard Deviation|Mean
70485|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-181|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
70486|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-29|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
70487|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
70488|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom.|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
70489|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
70490|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
70491|NCT01104493|Primary|Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)||Percentage of participants|||Number
70495|NCT01104155|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS||Months||95% Confidence Interval|Median
70496|NCT01104155|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS||Percentage of participants||95% Confidence Interval|Number
70497|NCT01104155|Secondary|Progression-Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who had not progressed, and were alive at the date of data cut-off or lost to Follow-up), progression-free survival was censored. Participants who did not progress in their disease were censored on the date of their last tumor assessment preceding the start of any additional anticancer therapy. PFS was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years|FAS||Months||95% Confidence Interval|Median
70498|NCT01104155|Secondary|Duration of Response (DOR)|DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.|From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years|FAS||Months||95% Confidence Interval|Median
70499|NCT01104155|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR and the corresponding 95% two-sided confidence intervals (CI) were estimated for each treatment regimen using the Clopper-Pearson method for calculating the exact binomial CI. (CR + PR)|From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)|Full analysis set (FAS) (Intent-to-treat population) included all participants who took at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
70500|NCT01104116|Secondary|Change in Lesion Characteristics to Assess Benefit of PET Scans|The secondary outcome that we are interested in studying is the benefit of PET scan as compared to other imaging modalities, such as CT, MRI, and EUS. Thus, Patients will also have CT, MRI, and EUS imaging. We will look at how size, location, and branch of the IPMN lesion on PET compare to these other imaging modalities. The location, size, and pathology results of the actual surgical specimen will serve as the gold standard.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.|||||
70501|NCT01104116|Primary|Positive and Negative Predictive Value of PET Imaging for Identifying Malignant IPMN|The primary outcome will be to determine the positive and negative predictive values of [18F]-FDG PET imaging for identifying malignant IPMN lesions in patients who are to undergo surgical resection. We will determine the mean SUV that would provide optimal positive predictive value for malignant IPMN. IPMN lesions will be classified categorically as benign (adenoma or borderline ) or malignant (in situ or invasive carcinoma) and PET imaging will be classified categorically as negative or positive, with focal FDG uptake corresponding to pancreatic lesion.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.|||||
70502|NCT01104103|Secondary|First Stick Success|This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.|Five minutes (average)|||participants|||Number
70503|NCT01104103|Primary|Success|This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.|five minutes (average)|||participants|||Number
70504|NCT01103973|Secondary|Psychological Status|Psychological status is assessed by the following scales: Derogatis Affect Balance Scale (DABS), Perceived Stress Scale (PSS), State Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Fertility Problem Inventory (FPI), Infertility Self Efficacy Scale (ISES), Social Readjustment Scale (SRS), Short Form Health Survey (SF-36), Daily Monitoring Form (DMF). Other than the DMF, these are all published validated scales.|1 Year||||||
70506|NCT01103960|Secondary|Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.|Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From drug administration until end of treatment plus one day|Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period.||participants|||Number
70507|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories at 4 Weeks|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|4 weeks|FAS with LOCF||Number of participants|||Number
70508|NCT01103960|Secondary|DBP and SBP Control and Response After 4 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 4 weeks|FAS with LOCF||Number of participants|||Number
70509|NCT01103960|Secondary|Change From Baseline in SBP After 4 Weeks of Treatment|Seated trough SBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF||mmHg||Standard Deviation|Mean
70510|NCT01103960|Secondary|Change From Baseline in DBP After 4 Weeks of Treatment|Seated trough DBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF||mmHg||Standard Deviation|Mean
70511|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|8 weeks|FAS with LOCF||Number of participants|||Number
70512|NCT01103960|Secondary|DBP and SBP Control and Response After 8 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 8 weeks|FAS with LOCF||Number of participants|||Number
70513|NCT01103960|Secondary|Change From Baseline in SBP After 8 Weeks of Treatment|Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF||mmHg||Standard Error|Least Squares Mean
70514|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients|Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF and further restricted to the Chinese subgroup||mmHg||Standard Error|Least Squares Mean
70515|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment|Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.||mmHg||Standard Error|Least Squares Mean
70516|NCT01103934|Secondary|Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.|Baseline and 2 weeks|||units on a scale||Full Range|Median
70517|NCT01103934|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.|Baseline and 2 weeks|||units on a scale||Full Range|Median
70518|NCT01103713|Other Pre-specified|Summary of Plasma Desethylchloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.||ng/ml||Standard Deviation|Mean
70519|NCT01103713|Other Pre-specified|Summary of Plasma Chloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.||ng/ml||Standard Deviation|Mean
92750|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])||Baseline up to Month 7|||percentage of participants|||Number
70520|NCT01103713|Other Pre-specified|Summary of Serum Azithromycin Concentration Versus Time|AZ concentrations in the serum was determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming hour not specified as 0 hours on Day 7 and Day 14 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.||ng/ml||Standard Deviation|Mean
70521|NCT01103713|Other Pre-specified|Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level|Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value <0.8 times lower limit of normal was considered clinically significant.|Day 42|The safety analysis set consists of participants who received at least one dose of study medication.||Participants|||Number
70522|NCT01103713|Other Pre-specified|Incidence of Fever Based on Oral Temperature|Oral temp was taken by the fieldworker through Day 42.|Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42|ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Participants|||Number
70523|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Outcome of Birth|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.||Participants|||Number
70524|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Complications During Delivery?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.||Participants|||Number
70525|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Labor Induced?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 158 participants only.||Participants|||Number
70526|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.||Participants|||Number
70527|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Mode of Delivery|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.||Participants|||Number
70528|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Location of Delivery|All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.||Participants|||Number
70529|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Parasite count per microliter||Standard Error|Mean
70530|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Parasite count per microliter||Standard Error|Mean
70531|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Parasite count per microliter||Standard Error|Mean
70532|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70545|NCT01103466|Primary|Leakage Under the Base Plate|"Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is no leakage and 24 is complete leakage under the base plate."|At every change of base plate|ITT||units on a scale||Standard Deviation|Mean
70874|NCT01099761|Primary|Number of Subjects With Clinical Laboratory Adverse Reactions.|Number of subjects in each cohort with treatment-emergent adverse laboratory values judged to be at least possibly related to study drug|Baseline to End-of-Study Visit, approximately 24 weeks later.|||Number of subjects|||Number
70533|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70534|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70535|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70536|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70537|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70538|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70539|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.||Percentage of participants||95% Confidence Interval|Number
70540|NCT01103492|Primary|Number of Participants With Adverse Events|As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.|1 year|There was no analysis of the data. Feasibility study with only one subject enrolled||partipants|||Number
70541|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study|||participants|||Number
70542|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study|||participants|||Number
70543|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via FOBT, FIT or Colonoscopy|within 6 months of provider recommendation|||participants|||Number
70546|NCT01103414|Secondary|Changes in LDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 week|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.||nM||Standard Deviation|Mean
70547|NCT01103414|Secondary|Changes in HDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 weeks|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.||nM||Standard Deviation|Mean
70548|NCT01103414|Secondary|Presence of Edema Post Baseline During 12 Weeks Active Treatment|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both a baseline and post baseline edema assessment||participants|||Number
70549|NCT01103414|Secondary|Change From Baseline in Waist Circumference at Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both baseline and week 12 waist circumference assessments||cm||Standard Deviation|Mean
70550|NCT01103414|Secondary|Change in Body Weight From Baseline to Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||kg||Standard Deviation|Least Squares Mean
70551|NCT01103414|Secondary|Change From Baseline in RBC|Change from baseline at week 12 endpoint in red blood cell concentration|12 week|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments||10e-6 cells per uL||Standard Deviation|Mean
70552|NCT01103414|Secondary|Change From Baseline in Hemoglobin|Change from baseline at week 12 endpoint in hemoglobin concentration|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments.||g/dL||Standard Deviation|Mean
70553|NCT01103414|Secondary|Change From Baseline to Week 12 Endpoint in Hematocrit|Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||percentage of volume||Standard Error|Least Squares Mean
70554|NCT01103414|Secondary|Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin|Percent change from baseline to week 12 endpoint in high molecular weight adiponectin|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||percentage of baseline values||Standard Deviation|Least Squares Mean
70555|NCT01103414|Secondary|Change From Baseline in HbA1c|Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||percentage of hemoglobin||Standard Deviation|Least Squares Mean
70556|NCT01103414|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.|Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|Baseline, Week 12|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.||mg/dL||Standard Error|Least Squares Mean
70557|NCT01103362|Primary|The Frequency of Adverse Events||A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD|||percentage of patients-any adverse event|||Number
70558|NCT01103323|Secondary|Tumor Response|A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Percentage of participants|||Number
70559|NCT01103323|Secondary|Disease Control|Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Percentage of participants|||Number
70560|NCT01103323|Secondary|Objective Tumor Response|The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Percentage of participants|||Number
70561|NCT01103323|Secondary|Progression-free Survival (Based on Investigator’s Assessment)|Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT||Days||95% Confidence Interval|Median
70562|NCT01103323|Primary|Overall Survival|Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).|Intent to treat (ITT)||Days||95% Confidence Interval|Median
70563|NCT01103284|Secondary|Mean Number of Days With at Least One Hypoglycemic Event||Baseline to 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit||days||Standard Error|Mean
70564|NCT01103284|Secondary|Frequency of Hypoglycemic Events|Total number of days with at least one hypoglycemic event recorded|Baseline to 25 Months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit||days|||Number
70565|NCT01103284|Other Pre-specified|Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study|Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.||percentage of subjects||95% Confidence Interval|Number
70566|NCT01103284|Secondary|Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%|The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.||percentage of subjects||95% Confidence Interval|Number
70567|NCT01103284|Primary|Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months|Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit||nmol*min/L||Standard Error|Mean
70568|NCT01103271|Secondary|Pre-Post Efficacy|The magnitude of the pre-post effect across 4 weeks of treatment, as measured by the Hamilton Rating Scale for Depression-17 (HAMD-17). The HAMD-17 measures depression severity, and has a minimum value of 0 and a maximum value of 52 units on a scale, where higher scores indicate more severe depression.|Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)|||units on a scale||Standard Deviation|Mean
70569|NCT01103271|Primary|Feasibility|The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.|One year|The number of participants analyzed is the number of participants screened.||screens|||Number
70570|NCT01103232|Primary|Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles|Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.|6 weeks (The change calculated as 6 months minus baseline)|||Newton meters||Standard Deviation|Mean
70571|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.||Percentage of participants|||Number
70572|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.||Percentage of participants|||Number
70573|NCT01103063|Secondary|Percentage of Participants With Pre-eclampsia From Week 20 to Delivery|Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.|From Week 20 to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N= Number of participants with available data.||Percentage of participants||95% Confidence Interval|Number
70875|NCT01099761|Primary|Number of Subjects With Adverse Reactions.|Number of subjects in each cohort with a treatment-emergent adverse event considered at least possibly related to study drug|From treatment initiation to End-of-Study Visit, approximately 24 weeks later|||Number of subjects|||Number
70574|NCT01103063|Secondary|Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery|Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.|Up to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.||Percentage of participants||95% Confidence Interval|Number
70575|NCT01103063|Secondary|Percentage of Neonates With Ophthalmia Neonatorum at Birth Period|Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Total live births.||Percentage of neonates||95% Confidence Interval|Number
70576|NCT01103063|Secondary|Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.|Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
70577|NCT01103063|Secondary|Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation|Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
70578|NCT01103063|Secondary|Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation|Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
70579|NCT01103063|Secondary|Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation|Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
70580|NCT01103063|Secondary|Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation|Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with lab test results at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
70581|NCT01103063|Secondary|Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation|Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.|Upto 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.||Percentage of participants||95% Confidence Interval|Number
70582|NCT01103063|Secondary|Percentage of Participants With Cord Blood Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with cord blood smear parasite counts at delivery.||Percentage of participants||95% Confidence Interval|Number
70583|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at delivery.||Percentage of participants||95% Confidence Interval|Number
70584|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at 36-38 weeks of gestation.||Percentage of participants||95% Confidence Interval|Number
92751|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)||Baseline up to Month 7|||percentage of participants|||Number
70585|NCT01103063|Secondary|Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery|This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.||Percentage of participants||95% Confidence Interval|Number
70586|NCT01103063|Secondary|Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery|This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.||Number of episodes||95% Confidence Interval|Least Squares Mean
70587|NCT01103063|Secondary|Birth Weight of Live Borne Neonate|Birth weight of live borne neonates were calculated in grams.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of live births with available data.||grams||95% Confidence Interval|Least Squares Mean
70588|NCT01103063|Secondary|Percentage of Perinatal or Neonatal Deaths|Percentage of perinatal or neonatal deaths were noted.|Day 28 after delivery.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.||Percentage of neonates||95% Confidence Interval|Number
70589|NCT01103063|Secondary|Percentage of Neonates With Congenital Abnormalities at Birth|Neonates with congenital abnormalities at birth were noted.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.||Percentage of neonates||95% Confidence Interval|Number
70590|NCT01103063|Secondary|Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.|Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.|Baseline, at 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.||g/dL||95% Confidence Interval|Least Squares Mean
70591|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation|Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total Outcomes.||Percentage of participants||95% Confidence Interval|Number
70592|NCT01103063|Secondary|Sexually Transmitted Infection (STI) Episodes Per Participant|Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).|Approximately 40 weeks of gestational age .|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.||Number of episodes||95% Confidence Interval|Least Squares Mean
70593|NCT01103063|Secondary|Percentage of Participants With Placental Malaria at Delivery Based on Histology|Participants positive for placental malaria at delivery were evaluated based on placental histology.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with a histology parasite evaluation at delivery.||Percentage of participants||95% Confidence Interval|Number
70594|NCT01103063|Secondary|Percentage of Participants With Placental Parasitemia at Delivery|Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with placental parasite counts at delivery.||Percentage of participants||95% Confidence Interval|Number
70595|NCT01103063|Secondary|Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation|Anemia was defined as Hb <11 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.||Percentage of Participants||95% Confidence Interval|Number
70596|NCT01103063|Secondary|Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation|Severe maternal anemia was defined as Hb <8 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.||Percentage of participants||95% Confidence Interval|Number
71194|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
70597|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. N=Total Live Births.||Percentage of neonates||95% Confidence Interval|Number
70598|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in ITT Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total live births.||Percentage of neonates||95% Confidence Interval|Number
70599|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care.||Percentage of Participants||95% Confidence Interval|Number
70600|NCT01103063|Primary|Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.||Percentage of participants||95% Confidence Interval|Number
70601|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 48|Safety Population||participants|||Number
70602|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 24|Safety Population||participants|||Number
70603|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.||participants|||Number
70604|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.||participants|||Number
70605|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.||participants|||Number
70617|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 24|Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a viral load result obtained during that visit period.||log10 copies/mL||Standard Deviation|Mean
72219|NCT01083186|Secondary|Change From Baseline in Urea Levels at Months 6 and 12|The urea normal range was 10-50 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
70606|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.||participants|||Number
70607|NCT01102972|Secondary|Number of Participants Who Experienced Death and/or Disease Progression|Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions.|From Baseline to Week 48|ITT-E Population||participants|||Number
70608|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48|The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 48|ITT-E Population||participants|||Number
70609|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24|The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 24|ITT-E Population||participants|||Number
70610|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 48|A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.||ratio||Standard Deviation|Mean
70611|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
70612|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 24|A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.||ratio||Standard Deviation|Mean
70613|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
70614|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 48|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 48 value minus the Baseline value.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a CD4+ cell count obtained during that visit period.||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
70615|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 24|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a CD4+ cell count obtained during that visit period.||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
70616|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 48|Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a viral load result obtained during that visit period.||log10 copies/mL||Standard Deviation|Mean
70645|NCT01102764|Secondary|Treatment Credibility: to Assess for Differences in Outcome Expectancy, Treatment Credibility Scales||1 year||||||
70646|NCT01102764|Secondary|Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA): 16 Item Self Report Scale, General Measure of Patient Satisfaction of Treatment||1 year||||||
70618|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.||Percentage of participants|||Number
70619|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.||percentage of participants|||Number
70620|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 48|ITT-E Population||Percentage of participants|||Number
70621|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 24|ITT-E Population. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <400 copies/mL at Week 24.||percentage of participants|||Number
70622|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.||Percentage of participants|||Number
70623|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.||percentage of participants|||Number
70624|NCT01102972|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.|Week 24|Intent-to-Treat (ITT)-Exposed Population: all participants exposed to at least one dose of study medication. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <50 copies/mL at Week 24.||percentage of participants|||Number
70625|NCT01102894|Secondary|Food Intake Diary|Total dietary fiber consumed.|Day 1|Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake||g||Standard Deviation|Mean
70626|NCT01102894|Secondary|Gastrointestinal Tolerance|Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.|Day 4|Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.||units on a scale||Standard Deviation|Mean
70627|NCT01102894|Primary|Whole Gut Transit Time|The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.|5 days|All participants had their transit time assessed.||hours||Standard Deviation|Mean
70628|NCT01102803|Secondary|Behavioral Avoidance Test (BAT)|During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0–100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome.|2 months|||units on a scale||Standard Deviation|Mean
70647|NCT01102764|Secondary|Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36): Self Report Scale Measures Health Status and Functioning Over the Past Four Weeks||1 year||||||
70629|NCT01102803|Secondary|Clinical Global Improvement Scale (CGI)|Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either “very much improved” or “much improved” on CGI-I (score ≤ 2). Remission was defined as either “normal” or “minimally ill” on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome.|2 months|||units on a scale||Standard Deviation|Mean
70630|NCT01102803|Secondary|Attitudes Towards Heights Questionnaire (ATHQ)|Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0–10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60.|2 months|||units on a scale||Standard Deviation|Mean
70631|NCT01102803|Primary|Acrophobia Questionnaire With Avoidance (AAVQ)|Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0–3) and anxiety (0–6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82–.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.|2 months|||units on a scale||Standard Deviation|Mean
70632|NCT01102777|Secondary|Change in Participant Satisfaction|"Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is Definitely True 5 is Definitely False to the question, I would recommend the Taking Healthy Steps walking program to another person with COPD. A negative change value indicates higher satisfaction score."|four to twelve months of study participation|This was only assessed on Intervention group participants who answered the question at either four or twelve months.||units on a scale||95% Confidence Interval|Mean
70633|NCT01102777|Secondary|Participant Retention|The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.|during study participation, up to twelve months|||day||95% Confidence Interval|Mean
70634|NCT01102777|Secondary|Study Reach Among Rural Participants|Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.|At baseline|number of rural participants.||percentage of possible eligible rural|||Number
70635|NCT01102777|Secondary|Goal Commitment for Intervention Participants|"Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as Strongly Disagree and 5 is Strongly Agree to the question, I am strongly committed to pursuing my step count goal. A negative change value indicates lower goal commitment."|change from four months and twelve months from enrollment|This measure was only assessed on the Intervention group, and only 146 participants answered the question at either time points.||units on a scale||95% Confidence Interval|Mean
70636|NCT01102777|Secondary|Change in Average Daily Step Counts|Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.|baseline and final two weeks of the intervention and the two weeks post intervention.|One Intervention participant was dropped from analysis due to being an extreme outlier.||steps||95% Confidence Interval|Mean
70637|NCT01102777|Secondary|Days of Hospitalization|Number of days of all-cause hospitalization during study participation.|during study participation, up to 12 months|||days|||Number
70638|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Nine Control and seventeen Intervention participants were missing data at 12 months.||units on a scale||Standard Deviation|Mean
70639|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Three Control and ten Intervention were missing values at 4 months.||units on a scale||Standard Deviation|Mean
70640|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George’s Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier.||units on a scale||95% Confidence Interval|Mean
70641|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George’s Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. In addition, not all participants had complete SGRQ data at both time points for analysis.||units on a scale||Standard Deviation|Mean
70642|NCT01102764|Secondary|Prior Experience With Computer and Audiovisual Technology: Short Measure to Learn More About Participants' Prior Experience and Comfort Level With Computers and Audiovisual Technology||1 year||||||
70643|NCT01102764|Secondary|Structured Clinical Interview for DSM-IV: Interview to Diagnosis Depression, Panic Disorder, and Substance Abuse||1 year||||||
70644|NCT01102764|Secondary|Service Delivery Perceptions Questionnaire: Assess Subjects' Perceptions About Variables Specifically Related to the Mode of Service Delivery (Quality of Communication, Ease of Use, Willingness to Use Treatment)||1 year||||||
70650|NCT01102764|Primary|BDI Scores at Pre and Post Treatment|Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.||units on a scale||Full Range|Mean
70651|NCT01102764|Primary|PCL Scores at Pre and Post Treatment|PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. Total scores on the PCL range from 17 to 85 (lower scores indicate less symptom severity). The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). The minimum score possible on this measure is 17, and the highest possible score is 85.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.||units on a scale||Full Range|Mean
70652|NCT01102764|Primary|The Major Objective of This Study is to Determine if PE Delivered Via Telemedicine is as Effective as In Person PE in Terms of (1) Clinical (PTSD and Depression); (2) Process (Treatment Satisfaction and Attrition); and (3) Economic (Cost) Outcomes.|Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions. Per protocol, participants could have as many as 12 treatment sessions.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.||sessions||Full Range|Mean
70653|NCT01102491|Secondary|Incidence of Rescue Antiemetic Administration|outcome assessor assessed the incidence of rescue antiemetic administration|within 48 hours after surgery||||||
70654|NCT01102491|Primary|Incidence of Nausea and Vomiting|outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting|within 48 hours after surgery|||participants|||Number
70655|NCT01102413|Secondary|Change in Hemoglobin Concentration From Baseline to Week 8||Baseline to week 8|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
70656|NCT01102413|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.||Baseline, 4 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.||g/dL||Full Range|Mean
70657|NCT01102257|Primary|Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content||Baseline and 3 Months|||Percentage Total Fatty Acids||Inter-Quartile Range|Median
70658|NCT01102257|Secondary|Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines||90 +/- 14 days following initiation of drug regimen||||||
70659|NCT01102257|Secondary|Change in Schirmer’s||90 +/- 14 days following initiation of drug regimen||||||
70660|NCT01102257|Secondary|Change in the Ocular Surface||90 +/- 14 days following initiation of drug regimen||||||
70661|NCT01102257|Secondary|Change in Quality of Life Associated With Chronic Pain||90 +/- 14 days following initiation of drug regimen||||||
70662|NCT01102257|Secondary|Change on Impact of Dry Eye on Everyday Life (IDEEL)||90 +/- 14 days following initiation of drug regimen||||||
70663|NCT01102257|Secondary|Change on Brief Ocular Discomfort Inventory (BODI)||90 +/- 14 days following initiation of drug regimen||||||
70664|NCT01102257|Primary|Change on Ocular Surface Disease Index (OSDI)||90 +/- 14 days following initiation of drug regimen||||||
70665|NCT01102218|Secondary|Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6||6 months||||||
70666|NCT01102218|Secondary|Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time||6 months||||||
70667|NCT01102218|Primary|Change in Erythropoietin Dose|Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.|Baseline and 6 months|The number of patients for analysis was based on those patient who had completed 6 months of treatment. The analysis was per protocol.||Units EPO||Standard Deviation|Mean
70668|NCT01101958|Primary|Lung Volume Reduction||30 Days|||percent||Inter-Quartile Range|Median
70669|NCT01101867|Secondary|1,5-anhydroglucitol Change|change in short-term measure of glycemia|day 1 to day 3||||||
70670|NCT01101867|Secondary|Treatment Satisfaction|treatment satisfaction questionnaire validated in-hospital|day 3||||||
70671|NCT01101867|Secondary|Rate of Change in Glucose||72 hour||||||
70672|NCT01101867|Secondary|Hypoglycemia|Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)|72 hour|||participants|||Number
70673|NCT01101867|Secondary|Postprandial Glucose|Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.||mg/dl||Standard Deviation|Mean
70674|NCT01101867|Primary|Mean Glucose|Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.||mg/dl||Standard Deviation|Mean
70773|NCT01100762|Primary|Number of Steps to Regain Balance|Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.|Data collection occurred before and immediately after each training session|||steps||Standard Deviation|Mean
70675|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity Score per day||Standard Deviation|Mean
70676|NCT01101841|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||kg/m2||Full Range|Median
70677|NCT01101841|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject’s total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
70678|NCT01101841|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).~The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.~Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).~Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).~Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.~The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percentage of participants|||Number
70679|NCT01101841|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject’s overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)~The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.~Responders: Subjects Achieving a Score of “Very Much Improved” Or “Much Improved” Or “Minimally Improved”.~Non Responders: Subjects with a Score of “No Change” Or “Minimally Worse” Or “Much Worse” Or “Very Much Worse”."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
70680|NCT01101841|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Percent of participants|||Number
70698|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.~Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
70681|NCT01101841|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Units on a scale||Full Range|Median
70682|NCT01101841|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).~Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of total number of subjects|||Number
70683|NCT01101841|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of participants|||Number
70684|NCT01101841|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||units on a scale||Full Range|Median
70685|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
70686|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot Flash Severity scores per week||Full Range|Median
70687|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
70712|NCT01101321|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
70688|NCT01101841|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.~The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Awakenings||Full Range|Median
70689|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per week||Full Range|Median
70690|NCT01101841|Secondary|Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.|"Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula:~Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline – number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%."|Week 24|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||percentage of total number of subjects|||Number
70691|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.~The results reported are:~Mean Baseline frequency of moderate to severe VMS~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 12"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.||Hot flashes per day||Standard Deviation|Mean
70692|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
70693|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).|||Subjects|||Number
70694|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).|||Subjects|||Number
70695|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).|||Subjects|||Number
70696|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).|||Subjects|||Number
70697|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance)|*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.|||||
70774|NCT01100762|Primary|Cadence|Cadence was measured in steps per minute|Data collection occurred before and immediately after each training session|||steps/min||Standard Deviation|Mean
70699|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
70700|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
70701|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.||Subjects|||Number
70702|NCT01101477|Secondary|The Global Tolerance for Flexible Bronchoscopy|After the recovery, patients will be asked about the tolerance of bronchoscopy performed to them by 10-point Verbal Analogus Scale (0: best tolerance, 10: worst tolerance)|After recovery||||||
70703|NCT01101477|Secondary|The Cooperation of Patients From the View of Bronchoscopists|After the bronchoscopy, the bronchoscopist will be asked by 10-point Verbal Analogus Scale (0: the best cooperation, 10: the worst cooperation) to express how they fell about the cooperation of patients undergoing the bronchoscopy.|After bronchoscopy||||||
70704|NCT01101477|Secondary|The Total Doses of Propofol During Induction and Overall Procedures|The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.|after bronchoscopy||||||
70705|NCT01101477|Secondary|The Recovery Time to Orientation|The recovery time to orientation was defined as the time between finishing bronchoscopy to the time when the patients could spontaneously open their eyes, recall their date of birth, and correctly perform finger-nose test.|after bronchosocpy||||||
70706|NCT01101477|Primary|The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy|The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.|During sedative induction and bronchoscopy||||||
70707|NCT01101477|Primary|The Number of Patients With Hypoxemia During Flexible Bronchoscopy|"Hypoxemia is defined as:~Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration"|During sedative induction and bronchoscopy|The participants who received intervention completely were analyzed.||participants|||Number
70708|NCT01101464|Primary|Pharmacokinetic Parameter of Area Under the Curve (AUC) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).||ng*h/mL||Standard Deviation|Mean
70709|NCT01101464|Primary|Pharmacokinetic Parameter of Time of Occurrence of Cmax (Tmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2"|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).||Hours||Full Range|Mean
70710|NCT01101464|Primary|Pharmacokinetic Parameter of Maximum Plasma Concentration (Cmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).||ng/mL||Standard Deviation|Mean
70711|NCT01101321|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
70713|NCT01101321|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
70714|NCT01101308|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70715|NCT01101308|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70716|NCT01101308|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
70717|NCT01101191|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70718|NCT01101191|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70719|NCT01101191|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over a 72-hour period.|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
70720|NCT01101178|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics; Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70721|NCT01101178|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values.|Blood samples collected over 72-hour period|Full Analysis Population for pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70722|NCT01101178|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
70723|NCT01101165|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in period 2 was excluded from this PK analysis.||ng*h/mL||Standard Deviation|Mean
70724|NCT01101165|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in Period 2 was excluded from this PK analysis.||ng*h/mL||Standard Deviation|Mean
70725|NCT01101165|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
70726|NCT01101022|Secondary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks|AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
70727|NCT01101022|Secondary|Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
70728|NCT01101022|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
70729|NCT01101022|Secondary|Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks|"Question 1: 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). Higher scores representing a more positive rating.~Question 4: 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). Lower scores represent better quality of life."|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
70730|NCT01101022|Secondary|Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
70731|NCT01101022|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 10 weeks post-dose|FAS||Percent of participants|||Number
70732|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 10 weeks post-dose|FAS||Percent of participants|||Number
70733|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS||Percent of participants|||Number
70734|NCT01101022|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Lower scores indicate reduction in symptoms.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
70735|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
70736|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
70737|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS||T-scores||Standard Error|Mean
70738|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to10 weeks|FAS||T-scores||Standard Error|Least Squares Mean
70739|NCT01101022|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
70740|NCT01101022|Primary|Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|Full Analysis Set (FAS) defined as all subjects who took 1 dose of investigational product in the double-blind evaluation phase and had 1 primary efficacy assessment.||T-scores||Standard Error|Least Squares Mean
70775|NCT01100762|Primary|Gait Velocity|Gait Velocity was measured in meters per second|Data collection occurred before and immediately after each training session|||m/s||Standard Deviation|Mean
70741|NCT01100944|Secondary|Relative Changes in T Cell Immunoglobulin Domain and Mucin Domain-3 (TIM3)-Expressing Cluster of Differentiation 8 (CD8)+Tcells|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.||Relative fold change||Full Range|Median
70742|NCT01100944|Secondary|Relative Changes in the Number of Tregs With Treatment|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.||relative fold change||Full Range|Median
70743|NCT01100944|Secondary|Relative Change Observed in Total Protein Hyperacetylation of Cluster of Differentiation 3 (CD3)+T Cells With Belinostat|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Two samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.||Relative fold change||Full Range|Median
70744|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)/Dose|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||hr*ng/ml/mg||Standard Deviation|Mean
70745|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF))|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||hr*ng/ml||Standard Deviation|Mean
70746|NCT01100944|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to reach peak concentration after drug administration.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||Hour||Standard Deviation|Mean
70747|NCT01100944|Secondary|Maximum Plasma Concentration (Cmax)/Dose|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||ng/ml/mg||Standard Deviation|Mean
70748|NCT01100944|Secondary|Maximum Observed Plasma Concentration (Cmax) of Belinostat|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|One patient was excluded from pharmacokinetic analysis due to insufficient sampling in dose level 2. Dose normalized parameters are normalized to absolute total dose (over 48 hours continuous intravenous infusion (CIVI)) for that patient, not dose level.||ng/ml||Standard Deviation|Mean
70749|NCT01100944|Secondary|Total Clearance (CL) of Belinostat|Clearance is the amount of time for the drug to be eliminated from the body.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|||L/hr||Standard Deviation|Mean
70750|NCT01100944|Secondary|Time to Half Life (t1/2) of Belinostat|Half life is the duration of time for the drug to be reduced to half the original amount.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose.|||Hour||Standard Deviation|Mean
70751|NCT01100944|Secondary|Overall Survival (OS)|Overall survival is defined as the on-study date until the date of death or progression as appropriate.|Start of treatment to time of death, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.||months||Full Range|Median
70752|NCT01100944|Secondary|Progression Free Survival (PFS)|Duration of time from start of treatment to time of progression or death whichever occurs first.|Start of treatment to time of disease progression or death whichever occurs first, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.||months||Full Range|Median
70753|NCT01100944|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria (e.g. Response Evaluation Criteria in Solid Tumors (RECIST)) are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|From the time of first response until date of progression, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response||months||95% Confidence Interval|Median
70754|NCT01100944|Secondary|Time to Response|Time to response is the time between the first day of treatment until first date of response (complete response (CR) + partial response (PR)) (whichever is first recorded).|From the first day of treatment until the date of first documented response, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||days||Full Range|Median
70756|NCT01100944|Secondary|Clinical Response|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||participants|||Number
70757|NCT01100944|Secondary|Treatment-related Grade 3 and 4 Adverse Events (Highest Grade Per Event Per Patient)|Here are the number of treatment -related grade 3 and 4 adverse events (highest grade per event per patient).|up to 122 months|||participants|||Number
70758|NCT01100944|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of events, see the adverse event module.|up to 122 months|||participants|||Number
70759|NCT01100944|Primary|Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies|Objective response rate is the number of participants with a best objective response of partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST) divided by the number of participants who had treatment.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.||percentage of participants||95% Confidence Interval|Number
70760|NCT01100944|Primary|Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat|A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|up to 122 months|||participants|||Number
70761|NCT01100944|Primary|Maximum Tolerated Dose (MTD) of Belinostat|The MTD is defined as the highest dose at which less than 2 out of 6 patients experienced a dose limiting toxicity (DLT). A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|2 years|||mg/m(2)|||Number
70762|NCT01100931|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|31.5 months|||Participants|||Number
70763|NCT01100931|Primary|Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 18 weeks|Phase I is not included here because this outcome measure is for phase II only.||Participants|||Number
70764|NCT01100931|Primary|Phase 1 Safe and Tolerable Phase 2 Dose.|"Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).~Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1."|1 year|Phase I dose was variable dosing schedule to determine maximum tolerated dose (MTD) with 22 patients analyzed. Dose was variable with MTD at 10mg/m^2.||mg/m^2|||Number
70765|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines) Amphetamine||24 weeks|||Urine Drug Screen|||Number
70766|NCT01100853|Secondary|Prior Admissions to Vogur Hospital|Number of prior admissions due to substance dependence. The term “prior admissions” refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.|Baseline|||Number of admissions||Standard Deviation|Mean
70767|NCT01100853|Secondary|Risk Assessment Battery|The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.|24 weeks|||Total Score||Standard Deviation|Mean
70768|NCT01100853|Secondary|Beck Depression Inventory|The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.|24 weeks|||BDI Score||Standard Deviation|Mean
70776|NCT01100762|Primary|Stride Length|Stride Length was measured in centimeters|Data collection occurred before and immediately after each training session|||cm||Standard Deviation|Mean
70777|NCT01100723|Secondary|Percent of Patients on Cinacalcet and Vitamin D Analogues|Compare the percent of patients on cinacalcet and vitamin D analogues at baseline and at 6 and 12 months after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|6 months and 1 year|Number of subjects with at least 1 laboratory analysis during the evaluation period.||percentage of subjects receiving med|||Number
70778|NCT01100723|Secondary|Percent of Patients Achieving Calcium Target ≤ 10.1|Compare the percent of patients achieving a calcium ≤ 10.1 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects with at least one laboratory value during evaluation period.||percentage of subjects in target|||Number
70779|NCT01100723|Secondary|Percent of Patients Achieving Phosphorous Target ≤ 4.5|Compare the percent of patients achieving a phosphorus of ≤ 4.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|||percent of participants in target|||Number
70780|NCT01100723|Secondary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 450|Compare the percent of patients achieving an intact PTH target of ≤ 450 pg/ml before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|||percent of participants in target|||Number
70781|NCT01100723|Primary|Percent of Patients Achieving Phosphorous Target ≤ 5.5|Compare the percent of patients achieving a phosphorus of ≤ 5.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|||percent of participants in target|||Number
70782|NCT01100723|Primary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 300|Compare the percent of patients achieving an intact Parathyroid hormone (PTH) target of ≤ 300 pg/ml before and after the application of a computerized dosing protocol for management of chronic kidney disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects who had at least one laboratory measurement during the assessment phase.||percentage of subjects meeting target|||Number
70783|NCT01100658|Secondary|Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior|Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function [BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form [CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores > or = 60 represent areas of significant behavior concern.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.|||||
70784|NCT01100658|Primary|Effectiveness of Methylphenidate on Neurocognitive Components|Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.|||||
70785|NCT01100606|Primary|Question 6 (Previous Pancreatic Enzyme Product [PEP])|"Acceptability questionnaire consists of 9 questions (Q) to assess the ease, time, overall satisfaction of study drug. Q6 included name of previous PEP administered. Q6 was reported as number of participants who used any PEP prior to screening."|Baseline|Safety analysis population included all participants who received at least 1 dose of study medication.||participants|||Number
70786|NCT01100606|Primary|Treatment Difference for Acceptability of Treatment|Acceptability questionnaire consists of 9 question (Q) to assess ease, time, overall satisfaction of study drug. Rated on 5-point scale for Q1-Q5 and Q7-Q9; Q6 was not rated and asked for name of previous PEP administered. Q1=overall ease of administration (1=not at all easy,2=somewhat,3=easy,4=very,5=extremely); Q2=time of administration (1=very short[<2 min],2=short[2-5 min],3=moderate[5-15 min],4=long[15-25 min],5=very long[>25 min]);Q3=overall infant acceptance(1=very easily,2=easily,3=same,4=with difficulty,5=with great difficulty);Q4=clear/complete instructions(1=not clear,2=somewhat,3=clear,4=very,5=extremely);Q5=overall satisfaction with dosing method (1=not satisfied,2=somewhat,3=satisfied,4=very,5=extremely);Q7=comparative ease of administration (1=much worse,2=worse,3=same,4=better,5=much better);Q8=comparative infant acceptance (1=much more difficult,2=more,3=same,4=easier,5=much easier);Q9=comparative overall satisfaction (1=much less,2=less,3=same,4=more,5=much more).|Baseline up to end of study (Day 21)|Intention-to-treat (ITT) population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of exocrine pancreatic insufficiency (EPI). Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||units on a scale||Full Range|Median
70787|NCT01100606|Secondary|Number of Participants With Abnormal Findings With Respect to Oral Mucosa|Safety assessed by the presence of lesions observed during a physical examination at each visit. Severity of lesions measured by investigator's assessment using the following scale: mild = asymptomatic or mild symptoms and treatment not indicated; moderate = moderate pain but not interfering with oral intake, modified diet indicated; severe = severe pain, interfering with oral intake and life threatening or fatal.|Baseline up to end of study (Day 21)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
70788|NCT01100606|Secondary|Number of Participants With Abnormal Clinical Laboratory and Vital Signs Findings||Baseline up to end of study (Day 21)|Data was reported in individual participant listings but not statistically summarized for analysis as planned.|||||
70789|NCT01100606|Secondary|Number of Abdominal Pain Symptoms|Symptoms of pain was classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of pain symptoms per day||Standard Deviation|Mean
70790|NCT01100606|Secondary|Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of flatulence per day||Standard Deviation|Mean
70791|NCT01100606|Secondary|Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of bloating per day||Standard Deviation|Mean
70792|NCT01100606|Secondary|Number of Stools With Signs of Blood and Visible Oil or Grease|Average number of stools with signs of blood and visible oil or grease of each participant was calculated from number of stools with signs of blood and visible oil or grease by the participant per day. Average number of stools with signs of blood and visible oil or grease during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of stools per day||Standard Deviation|Mean
70793|NCT01100606|Secondary|Number of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and diarrhea. Average number of stools categorized as per consistency of each participant was calculated from number of stools of specific consistency by the participant per day. Average number of stools categorized as per consistency during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of stools per day||Standard Deviation|Mean
70794|NCT01100606|Secondary|Daily Number of Stools|Average daily number of stools of each participant was calculated from frequency of stools by the participant per day. Average daily number of stools during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire on and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.||average number of stools per day||Standard Deviation|Mean
70795|NCT01100502|Secondary|Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin||Up to 12 months|ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)||participants|||Number
70796|NCT01100502|Secondary|Incidence of Adverse Events or Laboratory Abnormalities||Up to 12 months|Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis||participants|||Number
70797|NCT01100502|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause|Up to approximately 10 years||04/2021||||
70798|NCT01100502|Primary|Progression-free Survival by Independent Review|Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first|Up to approximately 4 years|Intention-to-Treat analysis set||months||95% Confidence Interval|Median
70799|NCT01100437|Other Pre-specified|Maximum Post-dose COWS in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Between 0.5 and 24 hours post-dose|ITT||units on a scale||Standard Deviation|Mean
70800|NCT01100437|Other Pre-specified|6-β-Naltrexone Plasma Concentration at First COWS ≥ 13 in Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of all participants with COWS ≥ 13||pg/mL||Standard Deviation|Mean
70804|NCT01100437|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Average AUC 0-∞ for Morphine, Naltrexone and 6-β-Naltrexol reported.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category||ng*h/mL||Standard Deviation|Mean
70805|NCT01100437|Secondary|Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase|Average AUC0-last for Morphine, Naltrexone and 6-β-Naltrexol. Area under the plasma concentration time-curve from time zero to the last measured concentration.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category||ng*h/mL||Standard Deviation|Mean
70806|NCT01100437|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase|Average AUC0-τ for Morphine, Naltrexone and 6-β-Naltrexol reported. τ=24 hours|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category||ng times h divided by mL (ng*h/mL)||Standard Deviation|Mean
70807|NCT01100437|Secondary|Plasma Decay Half-Life (t1/2) During the Treatment Phase|Average plasma decay half-life of morphine, naltrexone and 6-β-Naltrexol. Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category||h||Standard Deviation|Mean
70808|NCT01100437|Secondary|Volume of Distribution (Vd/F)During the Treatment Phase|Average Vd/F for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable date for the specific category||liter (L)||Standard Deviation|Mean
70809|NCT01100437|Secondary|Apparent Oral Clearance (CL/F) During the Treatment Phase|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category||liters/hour (L/h)||Standard Deviation|Mean
70810|NCT01100437|Secondary|Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase|Average Cmin for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category||ng/mL||Standard Deviation|Mean
70811|NCT01100437|Secondary|Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase|Average Cmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
70812|NCT01100437|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase|Average Tmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|Pharmacokinetic (PK) population: all randomized participants who received at least one dose of EMBEDA (whole or crushed) in the Treatment Phase and had at least one PK assessment completed in the Treatment Phase; n=number of participants with evaluable data for the specific category||hours (h)||Standard Deviation|Mean
70813|NCT01100437|Secondary|Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases|Average pain scores in the previous 24 hours using an 11 point NPRS ranging from no pain (0) to worst pain (10).|Baseline up to Day 63|ITT; N=number of participants with evaluable data; n=number of participants evaluated at the specific time point||units on a scale||Standard Deviation|Mean
70814|NCT01100437|Primary|Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA)|Intent-to-treat population (ITT): all randomized participants who received at least one dose of double-blind treatment in the Treatment Phase and had at least one post-dose pharmacodynamic assessment completed in the Treatment Phase.||participants|||Number
70815|NCT01100320|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis||ng*h/mL||Standard Deviation|Mean
70816|NCT01100320|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70817|NCT01100320|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
92752|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)||Baseline up to Month 7|||percentage of participants|||Number
70818|NCT01100307|Other Pre-specified|Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.~Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.~Positive change indicated improvement."|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Units on a scale||Standard Deviation|Mean
70819|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase|Retinal thickness was assessed by spectral-domain optical coherence tomography or OCT3000, a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70820|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70821|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70822|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.~Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 – 14 letters; Lost 1 - 9 Letters; No change or gained 1 – 9 letters; Gained 10 – 14 letters; Gained 15 letters or more."|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70823|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
70824|NCT01100307|Other Pre-specified|Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.~Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.~Positive change indicated improvement."|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Units on a scale||Standard Deviation|Mean
70825|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo. The anatomic layers within the retina, retinal thickness could be measured.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70826|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
72220|NCT01083186|Secondary|Change From Baseline in Creatinine Levels at Months 6 and 12|The creatinine normal range was 0.6-1.4 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
70827|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70828|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.~Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 – 14 letters; Lost 1 - 9 Letters; No change or gained 1 – 9 letters; Gained 10 – 14 letters; Gained 15 letters or more."|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70829|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
70830|NCT01100307|Secondary|Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Weeks 24 to 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70831|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Open Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48 and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
70832|NCT01100307|Secondary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70833|NCT01100307|Secondary|Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Up to 24 weeks|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70834|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Double Masked Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Letters||Standard Deviation|Mean
70835|NCT01100307|Primary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).||Participants|||Number
70836|NCT01100268|Secondary|Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.|Patients given Saving Inventory-Revised (SI-R), an evidence-based measure of three features of hoarding: excessive acquisition, difficulty discarding, and clutter. For the SI-R the minimum units are 0 and Maximum units on the total scale are 92. The higher the number on the SI-R, the more severe the symptoms. Response was defined as at least a 25% reduction on the SI-R.|4 weeks|||participants|||Number
70837|NCT01100268|Primary|Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale|Patients given Attention Deficit Hyperactivity Disorder Symptom Scale (ADHDSS), a measure of the features of Attention Deficit Hyperactivity Disorder including inattention, hyperactivity, and impulsivity. This scale has shown excellent reliability in prior studies of individuals with HD. For the ADHDSS the minimum units are 0 and Maximum units on the total scale are 54 (adult). The higher the number on the ADHDSS, the more severe the symptoms. Response was defined as at least a 30% reduction on the ADHDSS.|4 weeks|||participants|||Number
70838|NCT01100255|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|1 week|||participants|||Number
70839|NCT01100242|Secondary|Toxicity Profile|Toxicity is assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Toxicity profile is reported as the number of patients who received at least one dose of on-study treatment and experienced a grade 3 or grade 4 adverse event (AE). For a more complete listing of all AEs experienced by patients on study, please see the Adverse Event section.|42 days|||participants|||Number
70840|NCT01100242|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the percentage of patients who achieve a CR or PR|42 days|||percentage of participants|||Number
70841|NCT01100242|Primary|Progression Free Survival (PFS)|Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 weeks|||weeks||Full Range|Median
70842|NCT01100112|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the ulcerative colitis disease activity index (UCDAI), from baseline to week 8.~The UCDAI mucosal appearance subscore is graded as follows: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|8 weeks|All patients who received at least one dose of study drug.||percentage of patients|||Number
70843|NCT01100112|Secondary|Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.|Safety will be assessed by evaluating SAEs and AEs. The outcome measure data are the numbers of patients who experienced SAEs or other nonserious AEs.|Throughout the 8 week treatment period|All patients who received at least 1 dose of study drug.||participants|||Number
70844|NCT01100112|Secondary|The Secondary Efficacy Endpoint is Clinical Improvement|The secondary efficacy endpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of > or = 3 points from baseline.|After 8 weeks treatment period|All patients who received at least 1 dose of study drug.||percentage of patients|||Number
70845|NCT01100112|Primary|The Percentage of Patients Achieving Clinical Remission|"The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of < or = 1 with a score of 0 for both rectal bleeding and stool frequency, and > or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance).~The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum [worst] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = > 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|At the end of the 8 week treatment period|All patients who received at least 1 dose of study drug.||percentage of patients|||Number
70846|NCT01100086|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70847|NCT01100086|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70848|NCT01100086|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
70849|NCT01100073|Secondary|Number of Premature Discontinuations|Number of patients discontinuing the study prematurely|Week 0 to weeks 9-16 (end of study)|Total patients||Participants|||Number
70850|NCT01100073|Secondary|Incidence, Relationship and Seriousness of Adverse Events|Total number of adverse events (AEs), causality and level of seriousness|Week 0 to weeks 9-16 (end of study)|Total patients||Number of events|||Number
70851|NCT01100073|Secondary|Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration|Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II and III scores available||Points on a UPDRS scale||Standard Deviation|Mean
70852|NCT01100073|Secondary|Change From Baseline in UPDRS Part III Score at the End of Up-titration|Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part III scores available||Points on a UPDRS scale||Standard Deviation|Mean
70853|NCT01100073|Secondary|Change From Baseline in UPDRS Part II Score at the End of Up-titration|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II scores available||Points on a UPDRS scale||Standard Deviation|Mean
70855|NCT01100073|Primary|Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance|Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study PDQ-39 score available||unit on a scale||Standard Deviation|Mean
70856|NCT01100073|Primary|Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)|Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS tremor score (UPDRS items 16, 20, 21) available||Points on UPDRS scale||Standard Deviation|Mean
70857|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the left hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available||millimeters of tremor amplitude||Standard Deviation|Mean
70858|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the right hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available||millimeters of tremor amplitude||Standard Deviation|Mean
70859|NCT01100073|Primary|Change From Baseline in UPDRS Part III Score at the End of Maintenance|Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Week 0 to weeks 9-16|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available||Points on UPDRS scale||Standard Deviation|Mean
70860|NCT01100073|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available||Points on UPDRS scale||Standard Deviation|Mean
70861|NCT01099917|Primary|Changes in Neutrophil Counts|The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients|baseline and week 12|||cells/mm^3||95% Confidence Interval|Mean
70862|NCT01099774|Primary|Average Eye IOP at Week 2|Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 2|Intent to Treat Population: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
70863|NCT01099774|Primary|Average Eye IOP at Week 6|Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 6|Intent to Treat Population: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
70864|NCT01099774|Primary|Average Eye IOP at Week 12|Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.|Baseline, Week 12|Intent to Treat Population: all randomized patients.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
70865|NCT01099774|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12|Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.|Baseline, Week 12|Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
70866|NCT01099761|Secondary|Change in Pulmonary Function Test (MEP)|Maximum Expiratory Pressure (MEP); 3 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Stuidy Visit, approximately 24 weeks|||cm H2O||Standard Deviation|Mean
70867|NCT01099761|Secondary|Change in Pulmonary Function Test (MIP)|Maximum Inspiratory Pressure (MIP); 2 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit. approximately 24 weeks|||cm H2O||Standard Deviation|Mean
70868|NCT01099761|Secondary|Change in Pulmonary Function Tests (FVC)|Forced Vital Capacity (FVC); 1 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit, approximately 24 weeks later.|||Liters||Standard Deviation|Mean
70869|NCT01099761|Secondary|Change From Baseline in Time to Travel 10 Meters (Standardized 10-Meter-Walk/Run Test).||Baseline to End-of-Study Visit, approximately 24 weeks later.|||Change (sec) in 10MWT from baseline||Standard Deviation|Mean
70870|NCT01099761|Secondary|Change in Distance Traveled in 6 Minutes (Standardized 6-Minute-Walk Test).|Change in distance traveled in 6 minutes (standardized 6-Minute-Walk Test); stratified by baseline age (<10 years vs. >=10 years)|Baseline to End-of-Study Visit, approximately 24 weeks later.|||change (m) in 6MWT from baseline||Standard Deviation|Mean
70871|NCT01099761|Secondary|Percent Change in Muscle Strength Score by Hand-held Myometry.|Manual Muscle Testing (MMT) is a procedure to measure the function and strength of individual muscles and muscle groups. Hand-held myometry, using a device known as a dynamometer, is one method used for MMT. The dynamometer is held against the patient's limb by the examiner and the patient is asked to resist the force applied by the examiner. The dynamometer measures the force applied by the patient, providing a quantitative and objective assessment of strength of the particular muscle or muscle group. The effectiveness of a therapeutic intervention on muscle strength, as measured by hand-held myometry, can be assessed by comparing post-treatment to pre-treatment (baseline) measurements.|Baseline to End-of-Study Visit, approximately 24 weeks later.|||percentage change from baseline||Standard Deviation|Mean
70872|NCT01099761|Secondary|Percent Change in Lumbar Spine Bone Mineral Density by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.|||percentage change from baseline||Standard Error|Mean
70876|NCT01099709|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70877|NCT01099709|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over a 72-hour time period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng*h/mL||Standard Deviation|Mean
70878|NCT01099709|Primary|Cmax - Maximum Observed Plasma Concentration|Bioeqivalence based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.||ng/mL||Standard Deviation|Mean
70879|NCT01099618|Primary|Length of Remission|For those patients that are able to discontinue insulin therapy at or <12 weeks, how long were they able to well controlled with an A1c <7% on the agent that they were randomized to.|3 years|||days||Full Range|Median
70880|NCT01099579|Secondary|Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir|Calculated as CLT/F divided by body weight|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||L/h per kilogram||Full Range|Geometric Mean
70881|NCT01099579|Secondary|Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir|Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose.|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||L/h||Full Range|Geometric Mean
70882|NCT01099579|Secondary|Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||Hours||Full Range|Median
70883|NCT01099579|Secondary|Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||ng*h/mL||Full Range|Geometric Mean
70884|NCT01099579|Secondary|Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)||ng/mL||Full Range|Geometric Mean
70885|NCT01099579|Secondary|Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir|Criteria for resistance testing= meeting at least 1 of the following: <1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level >200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a participant who had previously achieved a plasma HIV RNA level <50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration [IC50] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility.|From Day 1 to Week 48|Participants who met the criteria for virologic failure||Participants|||Number
70886|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder||Percentage of lymphocytes||Standard Error|Mean
70887|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder||Percentage of lymphocytes||Standard Error|Mean
70888|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder||Cells/mm^3||Standard Error|Mean
70889|NCT01099579|Primary|Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events|CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.|From Day 1 to Week 48|||Participants|||Number
70890|NCT01099579|Primary|Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48||From Baseline to Week 48|All participants who received at least 1 dose of atazanavir and were evaluable||Milliseconds||Standard Deviation|Mean
70934|NCT01098851|Primary|Number of Participants Requiring Airway Support|Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.|3 hours|||Participants|||Number
70891|NCT01099579|Primary|Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4|ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.|From Day 1 to Week 48|All participants who received at least 1 dose of atazanavir; n=number of evaluable participants.||Participants|||Number
70892|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder||Cells/mm^3||Standard Error|Mean
70893|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had an HIV RNA measurement on ATV powder at Week 48||Log10 c/mL||Standard Error|Mean
70894|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight|Participants who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48|From Baseline to Week 48|Participants who received at least 1 dose of atazanavir and who had HIV RNA while taking atazanavir powder at Week 48||Log10 c/mL||Standard Error|Mean
70895|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status|The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis.|From Day 1 to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who did not switch to the ATV capsule formulation on or before Week 48||Percentage of participants|||Number
70896|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight|The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window.|From Day 1 to Week 48|Participants who received at least 1 dose of atazanavir and who did not switch to the capsule formulation at or before Week 48||Percentage of participants|||Number
70897|NCT01099579|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 to Week 48|All participants who received at least 1 dose of active atazanavir powder.||Participants|||Number
70898|NCT01099475|Secondary|Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by ALAT level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3.|ALAT area under curve from start of surgery up until postoperative day 3|||IU*h/L||Standard Error|Mean
70899|NCT01099475|Secondary|Amount of Blood Loss|amount of blood in the suction container (and, if applicable, in the weighted gauzes)|at the end of liver surgery, an average of 225 minutes|||mL||Full Range|Median
70900|NCT01099475|Secondary|Post-resectional Complications|morbidity and mortality occuring after liver surgery graded according to Clavien-Dindo's grading system. In short, any deviation from the postoperative course without the need for pharmacological, radiological or surgical intervention was classified as Clavien-Dindo grade 1; complications requiring pharmacological treatment were graded as grade 2; complications requiring surgical or radiological intervention not under general anesthesia as grade 3a and under general anesthesia as grade 3b; grade 4 complications were life-threatening complications requiring intensive care unit care because of single organ dysfunction (grade 4a) or multiple organ dysfunction (grade 4b); mortality was classed as grade 5.|within 90-days after initial liver surgery|||participants|||Number
70901|NCT01099475|Primary|Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by L-FABP) level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3. This continuous variable with repeated measurements was summarized as area under the curve (AUC) from baseline to postoperative day 3 (as described in Matthews JN, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. Bmj 1990;300:230-5).|L-FABP area under curve from start of surgery up until postoperative day 3|||ng*h/mL||Standard Error|Mean
70902|NCT01099397|Primary|Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment|A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.|Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)|Only including participants with data at each time point||participants|||Number
70903|NCT01099358|Primary|Cetuximab Pharmacokinetics: Confirmatory Serum Concentration||Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion.|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
70904|NCT01099358|Primary|Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.||Hours (h)||Full Range|Median
70905|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.||Hours (h)||Full Range|Median
70906|NCT01099358|Primary|Cetuximab Pharmacokinetics: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
70907|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.||micrograms/milliliters(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
70908|NCT01099358|Primary|Cetuximab Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B or C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
70909|NCT01099358|Primary|Total Cisplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
70910|NCT01099267|Primary|Cause of Death for Participants Who Died|Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.|up to 7 years|Safety population of participants who died||participants|||Number
70911|NCT01099267|Primary|Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)|Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.||months||95% Confidence Interval|Median
70912|NCT01099267|Primary|Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up|Count of participants who progressed to AML at the time of the extension study follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.||participants|||Number
70913|NCT01099267|Primary|Kaplan Meier Estimate for Overall Survival|Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population||months||95% Confidence Interval|Median
70914|NCT01099267|Primary|Participants Survival Status as of the Time of the Extension Study Follow-up|Count of participants who were alive or deceased at the time of the extension study follow-up.|up to 7 years|Intent to treat population||participants|||Number
70915|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 48 weeks|Intention-to-Treat Population Analysis||participants|||Number
70916|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 24 weeks|Intention-to-Treat Population Analysis||participants|||Number
70917|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 4 weeks|Intention-to-Treat Population Analysis||participants|||Number
70918|NCT01099215|Secondary|Changes in Physical Exam|Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported|within 4, 24 and 48 weeks from baseline|Safety Population Analysis||participants|||Number
70919|NCT01099215|Secondary|Resting Ankle-brachial Index|ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD.|within 4, 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis||ratio||Standard Deviation|Mean
70920|NCT01099215|Secondary|Number of Patients Requiring Reintervention of Target Lesion / Target Vessel|Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel|up to 48 Weeks from study procedure|Intention-to-Treat Population Analysis||participants|||Number
70921|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
70922|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
70923|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
70924|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
70925|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
70926|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)||participants|||Number
70927|NCT01099215|Secondary|Incidence of Adverse Events, Laboratory Abnormalities||Up to 48 weeks from study procedure|Safety Population Analysis||participants|||Number
70928|NCT01099215|Secondary|Incidence of Serious Adverse Events||Up to 48 weeks from study procedure|Intention-to-Treat Population Analysis||participants|||Number
70929|NCT01099215|Secondary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:~Death~Major amputation~Procedural related serious adverse events~Investigational product related serious adverse events"|within 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis||participants|||Number
70930|NCT01099215|Primary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:~Death~Major amputation~Procedural related serious adverse events~Investigational product related serious adverse events"|within 4 weeks after study procedure|Intention-to-Treat Population Analysis||participants|||Number
70931|NCT01099202|Primary|Number of PRBC Transfusions During Initial 5 Months of Treatment|Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.||transfusions||Standard Deviation|Mean
70932|NCT01099202|Primary|Mean Number of RBC Units Transfused During Initial 5 Months of Treatment|Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.||PRBC Units||Standard Deviation|Mean
70933|NCT01099111|Primary|Colonic-Mucosa Associated Microbial Species Per Compiled Participants in 5 Different Arms|"The entire mucosal microbial community were profiled using high-throughput DNA sequencing and microarray technology. The microarray approach is based on 16S rRNA gene targeted oligonucleotide allowing the rapid detection of thousands of DNA sequences simultaneously and thus constitutes an ideal tool to generate a comprehensive and holistic view of the gut microbial community in all participants of all study arms.~Then they will be analysed between different colonic segments in each participant, pooled results of participants in each of the 5 arms will be compared to the measurable outcomes of other arms in general."|1 - 2 weeks|Each participant colonic mucosal microbiota populations pattern were analysed, and then compared to control to look for specific enrichments. If the DNA extract was not enough for sequencing, then the participant sample was excluded, however analysis calculation was based on all enrolled participants. The number analyzed here represent all enrolled||microbial species population||95% Confidence Interval|Number
70935|NCT01098851|Primary|Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow|Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.|3 hours|||Participants|||Number
70936|NCT01098812|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant|Available subjects at the final visit with measured uncorrected distance visual acuity.||LogMAR acuity values||Standard Deviation|Mean
70937|NCT01098812|Primary|Mean Percent Reduction in Cylinder|Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant compared to baseline|Subjects at the final visit with preoperative keratometric cylinder, intended/target cylinder and postoperative refractive cylinder.||percentage of reduction in cylinder||Standard Deviation|Mean
70938|NCT01098747|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70939|NCT01098747|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
70940|NCT01098747|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
70941|NCT01098747|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Hours||95% Confidence Interval|Median
70942|NCT01098747|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
70943|NCT01098747|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
70944|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70945|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70946|NCT01098747|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70973|NCT01098500|Secondary|Maximum BIL Elevation Reached During Follow-up|Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.||participants|||Number
70947|NCT01098747|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70948|NCT01098747|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70949|NCT01098747|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70950|NCT01098747|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
70951|NCT01098747|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
70952|NCT01098747|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 8 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
70953|NCT01098578|Other Pre-specified|Total Institutional Cost Savings|Difference between the total institutional cost of successfully treating 20 study patients with Floseal compared to the total institutional cost of treating the same number of patient with endoscopic surgery|End of study. Cost calculated after 20 patients were treated with Floseal|||US Dollars|||Number
70954|NCT01098578|Secondary|Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.|The institutional cost for the treatment of posterior epistaxis patients with posterior packing, endoscopic surgery, and endovascular embolization, at TOH were calculated and compared with the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using Floseal. All costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD x 1.03= total USD). For all of the patients treated in this study, the total institution cost was $24487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery, would have been $53933.89 (USD) or 2.2 times the actual expense. (Total cost 20 participants Floseal/expected total cost 20 endoscopic surgery*100)This represents savings of $29446.39 (USD) or 45.40%|30 days|||percentage of expected cost|||Number
70955|NCT01098578|Primary|Effectiveness of Floseal for the Treatment of Posterior Epistaxis.|Successful treatment using the gelatin-thrombin matrix protocol (Floseal) was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of Floseal® and the epistaxis did not resume within fourteen days of the treatment date.|Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.|||participants|||Number
70956|NCT01098539|Secondary|Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16|Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.|Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)|ITT population. Only participants with data available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
73362|NCT01074437|Primary|Compare Changes in IH Size and Vascularity for Subjects Randomized to Receive Initial Treatment With Corticosteroid-only Therapy Versus Combination Therapy With Corticosteroids Plus Propranolol||1, 2, and 6 months after treatment initiation||||||
70957|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 52: OC|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Kilograms||Standard Deviation|Mean
70958|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Kilograms||Standard Deviation|Mean
70959|NCT01098539|Secondary|Change From Baseline in Body Weight at Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.||Kilograms||Standard Error|Least Squares Mean
70960|NCT01098539|Secondary|Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|Week 2 to Week 52|ITT Population||Weeks||95% Confidence Interval|Median
70961|NCT01098539|Secondary|Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.|Week 2 to Week 52|ITT Population||Participants|||Number
70962|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
70963|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC|The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
70964|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
70965|NCT01098539|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF|The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
78230|NCT01018394|Other Pre-specified|Smokeless Tobacco Reduction Greater or Equal to 50%|Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline|baseline, week 4|||percentage of participants|||Number
70966|NCT01098539|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
70967|NCT01098539|Secondary|Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
70968|NCT01098539|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
70969|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
70970|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, and 20|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
70971|NCT01098539|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 26|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
70972|NCT01098500|Secondary|Median Time to the Maximum BIL Elevation During Follow-up|Median time (in months) between index date and date of maximum BIL elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.||months||Full Range|Median
70974|NCT01098500|Secondary|Median Time to the Maximum ALP Elevation During Follow-up|Median time (in months) between index date and date of maximum ALP elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.||months||Full Range|Median
70975|NCT01098500|Secondary|Maximum ALP Elevation Reached During Follow-up|Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.||participants|||Number
70976|NCT01098500|Secondary|Median Time to the Maximum AST Elevation During Follow-up|Median time (in months) between index date and date of maximum AST elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.||months||Full Range|Median
70977|NCT01098500|Secondary|Maximum AST Elevation Reached During Follow-up|Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.||participants|||Number
70978|NCT01098500|Secondary|Median Time to the Maximum ALT Elevation During Follow-up|Median time (in months) between index date and the date of maximum ALT elevation.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.||months||Full Range|Median
70979|NCT01098500|Secondary|Maximum ALT Elevation Reached During Follow-up|Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.||participants|||Number
70980|NCT01098500|Primary|Incidence of Hy’s Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)|Number of patients with Hy’s Law (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT, AST, ALP, and BIL (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug).||participants|||Number
70981|NCT01098500|Primary|Number of Hy’s Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)|Prevalence of patients with Hy’s Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug).||participants|||Number
70982|NCT01098500|Primary|Incidence of ALT >=3x ULN|Number of patients with ALT >=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug)||participants|||Number
70983|NCT01098500|Primary|Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)|Prevalence of patients with an ALT elevation >=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug.||participants|||Number
70984|NCT01098487|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy|On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; >1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; >30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population||Participants|||Number
70985|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study|Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population||Participants|||Number
71061|NCT01098032|Secondary|Changes in the Urine and Serum NGAL Concentration After Contrast Exposure|NGAL is a new biomarker which seems to be very promising in detecting kidney injury. prelimiary data suggest that urine and serum NGAL increase very early (within few horurs) after the occurrence og acute kidney damage. Therefore, NGAL may be a real marker of acute kidney injury.|7 days||||||
70986|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population||Participants|||Number
70987|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 2 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
70988|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 1 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
70989|NCT01098487|Primary|Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
70990|NCT01098487|Primary|Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
70991|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at Baseline|The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
70992|NCT01098487|Primary|Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline|The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis [MF]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. Participants with bone marrow biopsy data available in the relevant time period were included.||Participants|||Number
70993|NCT01098461|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK/PD Analysis Pop: all participants in the PK Analysis Pop with sufficient dosing history for inclusion in the PK/PD analysis. Modeled population PK data (analyzed using a non-linear mixed effect modeling approach) are presented. A one-compartment PK model with first-order absorption/elimination processes was selected to describe GSK716155 PK.||nanograms per milliliter||95% Confidence Interval|Mean
70994|NCT01098461|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population (Pop)||hour^-1||95% Confidence Interval|Mean
70995|NCT01098461|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population||Liters||95% Confidence Interval|Mean
70996|NCT01098461|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed||milliliters per hour||95% Confidence Interval|Mean
70997|NCT01098461|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed.|Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Participants|||Number
70998|NCT01098461|Secondary|Change From Baseline in Body Weight at Week 4, 8, 12, and 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Kilograms||Standard Deviation|Mean
70999|NCT01098461|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
71000|NCT01098461|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Percentage of HbA1c in the blood||Standard Deviation|Mean
71017|NCT01098240|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14|CGI-I was defined as a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 8 (double-blind baseline) 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71062|NCT01098032|Secondary|Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure|Cystatin C is an alternative biomarker of kidney damage. Cystatin C seems to be superior to serum creatinine an identifying kidney function and damage.|7 days||||||
71001|NCT01098461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomized participants with at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
71002|NCT01098318|Secondary|Treatment Emergent Side Effects Scale Will be Used to Assess Treatment-related Side Effects as a Secondary Outcome Measure.||12 weeks||||||
71003|NCT01098318|Secondary|Change in Suicide Ideation as Determined by the Columbia Suicide Form Will be a Secondary Outcome Measure.||12 weeks||||||
71004|NCT01098318|Secondary|Change in Sexual Function Will be a Secondary Outcome Measure.||12 weeks||||||
71005|NCT01098318|Secondary|Reduction in Depressive Symptoms as Measured by the Beck Depression Inventory Will be a Secondary Outcome Measure.||12 weeks||||||
71006|NCT01098318|Secondary|The Clinical Global Impression (CGI) Severity and Change Ratings Will be Secondary Outcome Measures.||12 weeks||||||
71007|NCT01098318|Primary|Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.|Hamilton Depression Rating Scale (HAM-D) is a validated, clinician-rated instrument for ascertaining the severity of MDD symptoms. The 28-item Hamilton Depression Rating Scale was used to determine the primary outcome of 17-item HAM-D score. The HAM-D will serves as the primary outcome measure. HAM-D17 score ranges from 0 to 68. Higher score indicates more depressed symptom.|12 weeks|||units on a scale||Standard Deviation|Mean
71008|NCT01098305|Secondary|Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.|Side Effects|Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)|||participants|||Number
71009|NCT01098305|Primary|7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.||At the end of treatment (12 weeks)|||participants|||Number
71010|NCT01098253|Secondary|Nine Item Patient Health Questionnaire (PHQ-9)|Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9). PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).||Percentage of participants with PHQ-9 <5|||Number
71011|NCT01098253|Primary|Hemoglobin A1C|HbA1c levels will be obtained in accordance with ADA guidelines (1) employing the in2it A1C Analyzer. The Analyzer offers accurate point of care HbA1c testing. Point of care testing using this device has acceptable precision and agreement in comparison with laboratory services|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).||Percentage of participants with HbA1c <7|||Number
71012|NCT01098240|Other Pre-specified|The Sheehan Suicidality Tracking Scale (STS)|The Sheehan Suicidality Tracking Scale (STS) measures treatment-emergent suicidal ideation as well as behaviors. It can be administered by a clinician or filled in by a participant. Prior to analysis, the STS was mapped to the Columbia Classification Algorithm of Suicide Assessment(C-CASA) categories, which has 9-item including completed suicide, suicide attempt, preparatory acts, suicidal ideation, self-injurious behavior, self-injurious no intent, unknown fatal,unknown non-fatal or other not deliberate. Participants who were mapped to C-CASA items were reported.|Week 8 (double-blind baseline) and weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Participants|||Number
71013|NCT01098240|Secondary|Plasma CP-601,927 Concentration|Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.|Week 11, 12 and 14|All randomized participants with at least one dose of study medication in DB (double blind) phase and one valid plasma concentration measurement collected during the DB phase was be included in the analyses of the PK endpoints. n = number of participants with evaluable data at each timeframe.||ng/mL||Standard Deviation|Mean
71014|NCT01098240|Secondary|Population Pharmacokinetics|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-601,927 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-601,927 concentrations|Weeks 11,12 and 14||||||
71015|NCT01098240|Secondary|Number of Participants With Response at Weeks 9 Through 14|Response was defined as greater than 50 percent reduction from double-blind baseline in MADRS total score.|Weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Participants|||Number
71016|NCT01098240|Secondary|Number of Participants With Remission at Weeks 9, 10, 12 and 14|Remission was defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI-I score less than 2 (’much’ or ’very much’ improved).|Weeks 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Participants|||Number
71063|NCT01098032|Secondary|Rate of Kidney Injury and Major Adverse Events|an increase in the serum creatinine concentration >=0.25% and >=0.5 mg/dl at 48 hours after contrast exposure|7 days||||||
71018|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14|SDS subscale is defined as a self-administered tool that measures functional impairment in 3-item including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale, for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71019|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14|SDS is defined as a self-administered tool that measures functional impairment including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale (0=not at all impaired, 10=extremely impaired), for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71020|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14|The SIS is to rate suffering with regard to irritability symptoms. The degree to which irritability interferes with work, social and family function is also queried. The total SIS score is the sum of 7 items. Each item is rated on a scale of 0-10, for a total numeric range of scores from 0 (not at all) to 70 (extremely). The SIS also records the number of days impaired by irritability.|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71021|NCT01098240|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14|CGI-S was defined as 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 8 (double-blind baseline) and weeks 9, 10, 12, 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71022|NCT01098240|Secondary|Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14|The Bech Melancholia is sum of scores on 6 items (items 1, 2, 7, 8, 10 and 13) pertaining to melancholia within HAM-D. The items are rated on a scale of 0-4, higher scores reflecting greater severity. Total possible score is 0-24.|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71023|NCT01098240|Secondary|Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14|The HAM-D25 is the 25-item version of a scale used to assess the range of depressive symptoms including depressed mood, work and activities, sleep, suicidal thinking, psychomotor agitation/retardation, appetite, sexual interest, anxiety, somatic symptoms, and cognitive symptoms. The items on the HAM-D were rated on a scale of 0-2 or 0-4, for a total numeric range of scores from 0 (depressive symptoms absent) to 72 (numerically highest level of depressive symptoms).|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71024|NCT01098240|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline) and weeks 9 through 13|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71025|NCT01098240|Primary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.||Units on a scale||Standard Deviation|Mean
71026|NCT01098162|Secondary|Incidence of Adverse Events During the Study|The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.|From Inclusion Visit (Day 0) up to Month 6|"All 571 subjects in the Safety Set are included in the analysis of this outcome measure.~Safety Set comprises all patients included who have been treated with Vimpat® at least once."||participants|||Number
71034|NCT01098110|Secondary|Percentage of Participants Who Were PANSS Responders.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder.|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Percentage of participants||95% Confidence Interval|Number
71027|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.~Change in number of partial-onset seizures with secondary generalization was derived as follows:~Change in SF per 28 days = (SF at 6 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.~Partial-onset seizures with secondary generalization can be classified into one of the following three groups:~Simple partial seizures evolving to generalized seizures~Complex partial seizures evolving to generalized seizures~Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
71028|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.~Change in number of partial-onset seizures with secondary generalization was derived as follows:~Change in SF per 28 days = (SF at 3 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.~Partial-onset seizures with secondary generalization can be classified into one of the following three groups:~Simple partial seizures evolving to generalized seizures~Complex partial seizures evolving to generalized seizures~Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 447 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
71029|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.~Change in number of partial-onset seizures was derived as follows:~Change in SF per 28 days = (SF at 6 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.~Partial-onset seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
71030|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.~Change in number of partial-onset seizures was derived as follows:~Change in SF per 28 days = (SF at 3 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.~Partial-onset seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 449 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||Seizures per 28 days||Standard Deviation|Mean
71031|NCT01098162|Primary|Clinical Global Impression of Change (CGI-C) at Month 6|"For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 515 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."||participants|||Number
71032|NCT01098110|Secondary|Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders.|The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved).|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Percentage of participants||95% Confidence Interval|Number
71033|NCT01098110|Secondary|Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score.|The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
92753|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])||Baseline up to Month 7|||percentage of participants|||Number
71035|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score.|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71036|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score.|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method||Score on a scale||95% Confidence Interval|Least Squares Mean
71037|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score.|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71038|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score.|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71039|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score.|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71040|NCT01098110|Secondary|Change From Baseline in PANSS General Psychopathology Score.|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71041|NCT01098110|Secondary|Change From Baseline in PANSS Negative Symptom Score.|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71042|NCT01098110|Secondary|Change From Baseline in PANSS Positive Symptom Score.|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71059|NCT01098032|Secondary|The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema)|Assessment of the rate of in-hospital major adverse events (i.e. acute myocardial infarction, c) renal failure requiring dialysis, and d) acute pulmonary edema) will give important informantion on the clinical relevance of prophylactic strategies in preventing CI-AKI|1 month||||||
71060|NCT01098032|Secondary|the Rate of Acute Renal Failure Requiring Dialysis|occurrence of renal failure requiring dialysis represents the haard endpoint of the study. Actually this represents the worst clinical consequence of CI-AKI.|1 month||||||
71043|NCT01098110|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the last observation carried forward (LOCF) method.||Score on a scale||95% Confidence Interval|Least Squares Mean
71044|NCT01098097|Secondary|Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)|Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.|Week 12|The population analyzed was 920 participants who received at least 1 dose of study drug and had data collected at the Week 12 visit||percentage of participants||95% Confidence Interval|Number
71045|NCT01098097|Primary|Incidence of Dose Modifications Due to Adverse Events|All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks|||percentage of participants|||Number
71046|NCT01098097|Primary|Incidence of Particular Adverse Events Resulting in Treatment Discontinuation|"All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).~The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)"|Up to 12 Weeks|||percentage of participants|||Number
71047|NCT01098097|Primary|Incidence of Treatment Discontinuations Due to Adverse Events|All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks|||percentage of participants|||Number
71048|NCT01098097|Primary|Incidence of Thrombocytopenia|Thrombocytopenia is a low blood platelet count|Up to 12 Weeks|||percentage of participants|||Number
71049|NCT01098097|Primary|Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.|Up to 12 Weeks|||percentage of participants|||Number
71050|NCT01098071|Secondary|Severity of Eye Symptoms at Baseline and Week 12|Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
71051|NCT01098071|Secondary|Severity of Sneezing at Baseline and Week 12|Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
71052|NCT01098071|Secondary|Severity of Nasal Itching at Baseline and Week 12|Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
71053|NCT01098071|Secondary|Severity of Nasal Congestion at Baseline and Week 12|Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
71054|NCT01098071|Secondary|Severity of Rhinorrhea at Baseline and Week 12|Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis||Score on a scale||Full Range|Mean
71055|NCT01098071|Primary|Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy||Baseline to 12 weeks|Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria)||Participants|||Number
71056|NCT01098071|Primary|Degree of Posterior Choana Obstruction at Baseline and Week 12|The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.|Baseline and Week 12|Only participants that completed the study are included.||Percent obstruction||Full Range|Mean
71057|NCT01098071|Primary|Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score|Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).|Baseline and Week 12|||Score on a scale||Full Range|Mean
71058|NCT01098032|Secondary|The Cost-effectiveness Ratio.|Assessement of the cost-effectiveness ratio is important when testing a new strategy of both therapy and prophylaxis. The Renalguard system is more expensive than the conventional hydration regimen. The cost of RenalGuard system is approximately 800 $. This cost will be justified only if the system is more effective in preventing CI-AKI and improving the clinical outcome, expecially reducing the lenght of ospedalization and the rate of dialysis.|1 month||||||
71064|NCT01098032|Primary|Number of Partecipants With Contrast-induced Acute Kidney Injury|The primary outcome measure will be the rate of development of CI-AKI in the 2 study arms (% of partecipants). CI-AKI is defined as an increase in the serum creatinine concentration >=0.3 mg/dL from the baseline value at 48 hours after administration of the contrast media or the need for dialysis.|at 48 hours following contrast exposure|all consecutive patients with chronic kidney disease scheduled for coronary and/or peripheral angiography and/or angioplasty with an estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2 and/or a risk score ≥11 were considered eligible for the study||participants|||Number
71065|NCT01097915|Secondary|Association Between PROP Sensitivity and BMI|Since individual ability to taste PROP may be correlated with BMI, we determined BMI (kg/m^2) in subjects classified as super-taster, medium taster and non-taster.Weight (kg) and height (m) were recorded for each subject.|7 months|||Kg/m^2||Standard Error|Mean
71066|NCT01097915|Secondary|Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity|electrophysiological recordings from the tongue of 43 subjects classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and genotyped for the specific receptor gene, TAS2R38. Density of fungiform papillae was also determined in each subject. The biopotentials were recorded by means of differential electrophysiological derivations between two silver electrodes, one in contact with the ventral surface of the tongue and one in perfect adhesion with the dorsal surface.|1 year||01/2017||||
71067|NCT01097915|Secondary|Association Between PROP Sensitivity and Saliva Zinc Ion Concentration|Since the enzymatic function of gustin (CA6) depends upon the presence of Zn at its active site we measured the salivary zinc ion concentration in subjects classified as super-taster, medium taster and non-taster.The salivary Zn2+ concentration was measured with a QuantiChromTM zinc Assay kit (Gentaur, Brussels, Belgium) where the color intensity is directly proportional to the Zn2+ concentration in the sample.|7 months|||microg/dl||Standard Error|Mean
71068|NCT01097915|Primary|Association Between Gustin Gene Polymorphism and PROP Sensitivity|"We examine associations between PROP status and the polymorphism rs2274333 (A/G) of the gene that codify for the salivary protein, gustin/CA6, Which has been suggested as a trophic factor that promotes growth and development of taste buds by acting on taste bud stem cells.~The intensity of taste perception evoked by PROP and NaCl solutions was estimated to evaluate PROP taster status and molecular analysis of the gustin gene polymorphism was performed in individuals classified by PROP status using PCR techniques."|7 months|||percentage of participants|||Number
71069|NCT01097863|Primary|Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.|"As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion? The positive yes responses are reported."|1 week|Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3).||participants|||Number
71070|NCT01097785|Secondary|Change in Measures of Reactive Oxygen Species in the Blood|Reactive Oxygen Species will be assessed after one month of placebo and statin therapy; measured using electron parametric resonance spectroscopy (EPR).|Baseline and 30 days|||EPR Arbitrary Units||Standard Error|Mean
71071|NCT01097785|Primary|Change in Muscle Sympathetic Nerve Activity in Bursts Per 100 Heartbeats|Muscle sympathetic nerve activity will be assessed after one month of placebo and statin therapy; measured in bursts/100 heartbeats.|Baseline and 30 days|||bursts/100 heartbeats||Standard Error|Mean
71072|NCT01097668|Secondary|The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).|Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.|16 and 20 weeks|ITT population at week 16 and 20 n=21 (Intradermal injection) ITT population at week 16 and 20 n=22 (Subcutaneous injection) MRI population at week 16 and 20 n=17 (Intradermal injection) MRI population at week 16 and 20 n=20 (Subcutaneous injection)||MRI lesions||95% Confidence Interval|Mean
71073|NCT01097668|Primary|Safety and Tolerability|Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.|48 weeks|The Safety population will be denoted as the ‘ITT population’ for the summarisation of safety endpoints.||participants|||Number
71074|NCT01097629|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
71075|NCT01097629|Primary|Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
71076|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71195|NCT01096017|Primary|FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation|FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation|At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.|||milliLiters x minutes||Full Range|Geometric Mean
71077|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71078|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71079|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71080|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71081|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71082|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71083|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71196|NCT01095978|Secondary|Termination of Treatment|The number of participants who discontinued treatment is summarized.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
71084|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71085|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71086|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71087|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71088|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71089|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71090|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
71427|NCT01092416|Secondary|Severe Angiographic Complications|Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.|Baseline procedure, with a mean total procedure time of 52.5 minutes.|||Participants|||Number
71091|NCT01097616|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
71092|NCT01097616|Primary|Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication||participants|||Number
71093|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71094|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71095|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
71096|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71097|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71098|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
71099|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71100|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.||minutes||95% Confidence Interval|Least Squares Mean
71101|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.||minutes||95% Confidence Interval|Least Squares Mean
71102|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71103|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71104|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71105|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
92754|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])||Baseline up to Month 7|||percentage of participants|||Number
71106|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71107|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71108|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71109|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.||minutes||95% Confidence Interval|Least Squares Mean
71110|NCT01096589|Secondary|Assessment of Safety by Incidence of Adverse Events.||3 weeks||||||
71111|NCT01096589|Primary|Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.||baseline and after 3 weeks of treatment|Patients must have completed the first week.||% volume change measured in mL.||Standard Deviation|Mean
71112|NCT01097460|Secondary|To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination||2 years||||||
71113|NCT01097460|Primary|Incidence of Treatment-emergent AE’s||2 years|Patients that received at least one dose||participants|||Number
71114|NCT01097421|Secondary|Patients Global Impressions (PGI)|Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.|8-12 weeks|FAS||Participants|||Number
71115|NCT01097421|Secondary|Clinical Global Impressions (CGI)|Clinical Global Impression (CGI) scale at final visit|8-12 weeks|FAS||Participants|||Number
71116|NCT01097421|Secondary|Pramipexole (PPX) Dose|mean Pramipexole (PPX) dose|pre-treatment and after 8-12 weeks|FAS||mg/24 hr||Standard Deviation|Mean
71117|NCT01097421|Secondary|Adverse Events (AE) Considered Related to Observed Medication|Some patients had not related AEs as well as related AEs.|8-12 weeks|Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation.||Patients|||Number
71118|NCT01097421|Secondary|Patient Preference|Patients were asked about their preference regarding frequency of intake (once daily or three times daily)|8-12 weeks|FAS||Participants|||Number
71119|NCT01097421|Primary|Level of Adherence|Points on Morisky scale|8-12 weeks|FAS||Participants|||Number
71120|NCT01097421|Primary|Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment|Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.|8-12 weeks|Full Analysis Set (FAS) defined as all patients who had taken at least one dose of the investigational medicinal product (IMP) and had a post-baseline assessment.||Percent||95% Confidence Interval|Number
71121|NCT01097343|Primary|Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230|P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.|Approximately 90 days|All patients completed the clinical protocol.||Number of Patients with PRU>230|||Number
71122|NCT01097304|Secondary|Changes in Cell Proliferation in BE Epithelium From Baseline to Post-intervention as Assessed by Proliferation-related Ki-67 Antigen (Ki67) Immunostaining, Percentage of Positively Stained Nuclei, in BE Tissue Sections|Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.|Baseline and 6 months||||||
71123|NCT01097304|Secondary|Changes in Gastric Bile Acid Composition, Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention|Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.|Baseline and 6 months||||||
71124|NCT01097304|Primary|Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining|8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.|Baseline to 6 months|participants with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis||% of strongly/moderately stained nuclei||Standard Deviation|Mean
71125|NCT01097005|Secondary|Bacteriological Relapse Related to Duration of Clarithromycin Administration|Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion|36 months|End of study (completers). Analysis of bacteriological relapse.||participants|||Number
71126|NCT01097005|Secondary|"Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator"|"Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales (Effective, Ineffective, Deterioration, Impossible)"|When treatment with clarithromycin is discontinued, from 40 days to 1232 days|Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.||Number of patients|||Number
71127|NCT01097005|Primary|Bacilli Negative Conversion Rate|Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin|During the treatment with clarithromycin, from 40 days to 1232 days|Analysis of the bacilli negative conversion||participants|||Number
71128|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||5 days postoperatively|||mg/L||Standard Error|Mean
71129|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||Postoperative 6th hours|||mg/L||Standard Error|Mean
71130|NCT01096875|Secondary|Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively||Change between statin and placebo groups at 30 days postoperatively|||percentage of LVEF||Standard Deviation|Mean
71131|NCT01096875|Primary|Endothelial Progenitor Cells (EPCs) Count (Cells/µl)||Postoperative 6th hours|||cells/µl||Standard Error|Mean
71132|NCT01096823|Primary|Disease Activity Scale (DAS)28|"is a combined index that measures disease activity in patients with RA and remains a more thorough, established alternative to standard medical exams. This index includes a 28 tender joint count, 28 swollen joint count, Erythrocyte Sedimentation Rate (ESR), and general health assessment using a visual analogue scale. The ESR indirectly measures inflammation in the body and involves collecting blood samples, which will be performed by a qualified phlebotomist.~The DAS score is a complicated formula based on many factors so there are no set ranges, but the published standards are as follows:~A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. Source: DAS-Score.nl. Available at http://www.das-score.nl/www.das-score.nl/index.html. Accessed February 5, 2009."|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
71133|NCT01096823|Primary|Health Assessment Questionnaire (HAQ)|"Items include questions about dressing and grooming, rising, eating, walking, hygiene, reaching, grip and making activities. The HAQ is one of the most widely recognized measures of patient functioning, with acceptable reliability and validity. It has been used successfully with adolescents as young as 13 years of age~Range: 0-100, lower scores indicate better health"|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
71134|NCT01096823|Primary|Pain Disability Index (PDI)|"The PDI assess the impact of pain on ability to participate in basic life activities, including social activity, sexual behavior, self-care and life-support activity. The PDI has been used with patients as young as 15. Good internal reliability (α = .82) and validity have been reported. It takes less than 5 minutes to complete.~7 items, total measure range: 0-70, higher scores = higher interference/disability"|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
71135|NCT01096823|Primary|Health Related Quality of Life - Short Form-36 (SF-36)|"The Health Related Quality of Life - Short Form-36 (SF-36) is a generic core HRQOL measure yielding an 8-scale profile of functional health and well being. The SF-36 performs comparatively better than other HRQOL measures in terms of reliability, validity, lightness of respondent/administrative burden. It can be completed in 5-10 minutes and has been used with children as young as 10 years of age.~Subscales - all ranges 0-100 with higher scores indicating increased quality of life Bodily Pain, 2 items General Health, 5 items Vitality, 4 items Mental Health, 5 items"|post intervention (within 2 weeks of completing intervention)|||units on a scale||Standard Deviation|Mean
71136|NCT01096810|Secondary|Antitumor Effect|To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis|Antitumor effect|immunophenotyping was not performed in this study|||||
71137|NCT01096810|Primary|Response Rate|"The response rate - percentage of participants with overall response.~Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least >50% reduction in SPEP, at least >90% reduction or <200 mg in UPEP, at least >50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate."|from date of start of treatment until the date of best documented response up to date of progression|||percentage of participants|||Number
71224|NCT01095796|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|Intent-to-treat (ITT) Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
71138|NCT01096810|Primary|Time to Progression|"To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles).~Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: >25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), >25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), >25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause)."|From date of treatment until the date of first documented progression|||cycles||Full Range|Median
71139|NCT01096771|Secondary|Hypertriglyceridemia|Defined as triglyceride level >400|96 hours|||participants|||Number
71140|NCT01096771|Secondary|Allergic Reactions||96 hours|||participants|||Number
71141|NCT01096771|Secondary|Hospital Length of Stay||30 days|||days||Standard Deviation|Mean
71142|NCT01096771|Secondary|Biomarkers (C-reactive Protein)||96 hours|||mg/L||Standard Deviation|Mean
71143|NCT01096771|Secondary|Organ Failures||30 days|||participants|||Number
71144|NCT01096771|Secondary|New Infection|We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.|30 days|||participants|||Number
71145|NCT01096771|Secondary|30 Day Mortality||30 days|||participants|||Number
71146|NCT01096771|Secondary|PaO2:FiO2 Ratio|PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.|4 days|||mmHg||Standard Deviation|Mean
71147|NCT01096771|Secondary|Ventilator Days||30 days|||days||Standard Deviation|Mean
71148|NCT01096771|Primary|Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations||96 hours|Each arm has one less subject than specified in the participate flow module. One is secondary to the fact that the subject refused the 2nd bronchoscopy and the other is because the primary physician felt the subject was too sick to undergo the 2nd bronchscopy.||pg/mL||Standard Deviation|Mean
71149|NCT01096680|Secondary|PVT Scores by Timepoint|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS||msec||Standard Error|Least Squares Mean
71150|NCT01096680|Secondary|Psychomotor Vigilance Task (PVT) Scores|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS||msec||Standard Error|Least Squares Mean
71151|NCT01096680|Secondary|KSS Scores by Timepoint|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS||Units on a scale||Standard Error|Least Squares Mean
71152|NCT01096680|Secondary|Karolinska Sleepiness Scale (KSS) Scores|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS||Units on a scale||Standard Error|Least Squares Mean
71153|NCT01096680|Primary|Maintenance of Wakefulness Test (MWT)|"The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to stay awake as long as possible during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better."|Over a period of 8 hours|Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment.||Minutes||Standard Error|Least Squares Mean
71154|NCT01096550|Primary|Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)||6 months post-baseline|||percentage of opioid dependent subjects|||Number
71155|NCT01096446|Secondary|Initiation of Glucose|Infants were monitored to see if insulin was started to control hyperglycemia.|First 7 days of life||||||
71156|NCT01096446|Secondary|Maintain Appropriate for Gestational Age Status at Discharge|Recorded all infant's weights at discharge and plotted the anthropometric values on the Fenton Growth Charts.|Entire hospital stay||||||
71157|NCT01096446|Secondary|Infants Will Achieve 90 Calories/Kilogram/Day|Monitored the calorie intake of infants to see which group was able to acheive 90 cal/kg/day from the total parenteral nutrition.|First 14 days of Life||||||
71158|NCT01096446|Secondary|Regain Birthweight|Infants in both groups weights were monitored to determine if giving higher infusions of intravenous fat emulsion helped the infants regain their birthweight sooner.|First 2 weeks of life||||||
71159|NCT01096446|Primary|Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl|Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.|First 7 days of life|This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater||participants|||Number
71160|NCT01096342|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Date at which the patient's objective status is first noted to be either an sCR, CR, PR, or VGPR to the earliest date progression is documented, assessed up to 3 years|Duration of Response was not analyzed due to lack of responses.|||||
71161|NCT01096342|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years|All 15 evaluable participants were analyzed for Progression-Free Survival.||months||95% Confidence Interval|Median
71173|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
71162|NCT01096342|Primary|Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.|"Complete Response (CR):~Negative immunofixation of serum and urine Normalization of FLC ratio < 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas~Stringent Complete Response (sCR):~CR, as above, with absence of clonal cells in bone marrow~Partial Response (PR):~One of the following:~A ≥ 50% reduction of measurable serum M-protein.~A reduction in 24h measurable urinary M-protein by ≥ 90% or to <200 mg per 24h.~A ≥ 50% decrease in the difference between involved and uninvolved FLC levels.~≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30%~A ≥50% reduction in the size of soft tissue plasmacytomas.~Very Good Partial Response (VGPR):~PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis."|Up to 3 years|Fifteen of the 16 accrued Phase II participants were analyzed (1 participant was a protocol violation).||participants|||Number
71163|NCT01096316|Secondary|Potential Facilitators and Barriers to Sustainability|Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.|18 months||||||
71164|NCT01096316|Secondary|Quality of Depression Care Indicators|Intervention impact on quality of depression care indicators and satisfaction with depression care. Number of participants receiving 4 or more mental health visits are reported. Receiving 4 or more mental health visits has previously been used in depression randomized control trials as a measure of the quality of depression treatment received by a patient|12 months|||participants|||Number
71165|NCT01096316|Primary|Functional Outcome|Impact of the intervention on functional outcomes of patients. Functional impairment was measured using the Sheehan Disability Scale. The Sheehan disability scale is the average of 3 items assessing impairment in social, work and family responsibilities. Each item is rated 0 (no impairment) to 10 (totally impaired) and the 3 ratings are averaged for the Sheehan disability scale reported below.|12 months|||units on a scale||Standard Deviation|Mean
71166|NCT01096316|Primary|Depression Treatment Outcome|Impact of the intervention on depression treatment outcomes, including change in depressive symptoms and treatment response. In particular, the depression scale from the Hopkins Symptom Checklist 20 (SCL-20) was used to assess depression severity at the assessments. The SCL-20 ranges from 0 (no depression) to 4 (severe depression),|12 months|||units on a scale||Standard Deviation|Mean
71167|NCT01096186|Secondary|Patient Global Impression (PGI)|"Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.~Patient Global Impression 0-7 – higher value indicates increased improvement from study start"|9 months|All enrolled subjects with available data||units on a scale||Standard Deviation|Mean
71168|NCT01096186|Secondary|Total UPDRS Parts I-IV|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient.~Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data||units on a scale||Standard Deviation|Mean
71169|NCT01096186|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study.~Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data||units on a scale||Standard Deviation|Mean
71170|NCT01096056|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
71171|NCT01096056|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
71172|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
71189|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
71190|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
71174|NCT01096056|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
71175|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
71176|NCT01096056|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
71177|NCT01096056|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
71178|NCT01096056|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR)|GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||fold increase||95% Confidence Interval|Geometric Mean
71179|NCT01096056|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Subjects|||Number
71180|NCT01096056|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Subjects|||Number
71181|NCT01096056|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Subjects|||Number
71182|NCT01096056|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
71183|NCT01096056|Primary|Number of Subjects Reporting Fever Grade 2 or Higher|Fever grade greater than or equal to 2 i.e. ≥2 was defined as axillary temperature >38 degree centigrade (°C).|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
71184|NCT01096017|Secondary|Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation|Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation|At two visits during a maximum of 15 days|||Minutes||Standard Deviation|Mean
71185|NCT01096017|Secondary|Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation|Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation.|At two visits during a maximum of 15 days|||Participants|||Number
71186|NCT01096017|Secondary|Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|Time to peak measurement of FEV1 (min)|At two visits during a maximum of 15 days|||Minutes||Full Range|Median
71187|NCT01096017|Secondary|Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percent change||Full Range|Geometric Mean
71188|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days|||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
71225|NCT01095757|Primary|Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg||Within the first 4 days following the first dose of Plerixafor|||participants|||Number
71197|NCT01095978|Secondary|Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)|Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.|Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)|The per-protocol population was analyzed.||Participants|||Number
71198|NCT01095978|Secondary|Adverse Effects|The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
71199|NCT01095978|Primary|Therapeutic Response|Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
71200|NCT01095978|Primary|Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)|Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.||Participants|||Number
71201|NCT01095978|Primary|Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia|Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.||Participants|||Number
71202|NCT01095978|Primary|Auscultation Findings|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
71203|NCT01095978|Primary|Dyspnoea|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
71204|NCT01095978|Primary|Cough and Its Character|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.||Participants|||Number
71205|NCT01095978|Primary|Body Temperature|Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1.||Participants|||Number
71206|NCT01095887|Primary|Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant||3 months after kidney transplant surgery|||participants|||Number
71207|NCT01095835|Other Pre-specified|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion|This outcome measure presents percentage of participants with a combined response of HBsAg < 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71208|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Below Limit of Quantification|HBV-DNA limit < 6 IU/mL was defined as below quantification.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71209|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71210|NCT01095835|Other Pre-specified|Percentage of Participants With ALT Normalization||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71211|NCT01095835|Secondary|Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy|Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.|At the end of the treatment period at Week 96|The ITT population for arm PEG-IFN+LAM96 included all participants randomized to PEG-IFN+LAM96 who received at least one dose of study medication.||percentage of participants|||Number
71212|NCT01095835|Secondary|Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment||At the end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication. Baseline values are included for those participants for whom a baseline value was measured. Change from baseline values includes only those participants with both a baseline value and a value for the summarized time period.||IU/mL||Standard Deviation|Mean
71213|NCT01095835|Secondary|Percentage of Participants Achieving Histological Response|Histological response was defined as an improvement by >/= 2 in the Necroinflammatory Grading and/or by an improvement by >/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71214|NCT01095835|Secondary|Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL|Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off <2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71215|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.|At the end of 24 weeks of follow-up at Week 120|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71216|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at the End of Treatment|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.|At end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71217|NCT01095835|Primary|Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period|Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to <20,000 copies/mL (<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
71218|NCT01095796|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).||percentage of participants|||Number
71219|NCT01095796|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT Analysis Set. The missing = excluded (M = E) method was used in which all participants with missing data were excluded from analysis.||cells/µL||Standard Deviation|Mean
71220|NCT01095796|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT Analysis Set||percentage of participants|||Number
71221|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 Modified Intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.||percentage of participants|||Number
71222|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
71223|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug||percentage of participants|||Number
71226|NCT01095757|Secondary|Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)||Within the first 4 days following the first dose of Plerixafor|||days||Standard Deviation|Mean
71228|NCT01095653|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)||Percentage of participants||Standard Error|Mean
71229|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)||kg||Standard Error|Mean
71230|NCT01095653|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PLMG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
71231|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
71232|NCT01095653|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||% of hemoglobin||Standard Error|Mean
71233|NCT01095510|Secondary|Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations|Data was not reported due to change in planned analysis.|Pre-dose, 2, 4, 8 hours post dose on Day 1; Day 2, 3, 5, 8|No participant agreed to obtain pharmacokinetic (PK) blood sampling for antigenic and functional C1 INH levels. Hence, it was planned not to be analyzed.|||||
71234|NCT01095510|Secondary|Time to Complete Resolution of the Attack||Within 1 week following treatment|ITT-E population.||hours||Full Range|Median
71235|NCT01095510|Secondary|Time to Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|ITT-E population||hours||Full Range|Median
71236|NCT01095510|Primary|Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|Intent-to-treat efficacy (ITT-E) population included all participants with baseline and at least one post-infusion investigator assessment of the hereditary angioedema (HAE) attack.||participants|||Number
71237|NCT01095497|Secondary|Number of Subjects With C1INH Antibodies||18 days in each treatment period||||||
71238|NCT01095497|Secondary|C1 Inhibitor (C1INH) and C4 Levels||18 days in each treatment period||||||
71239|NCT01095497|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.||18 days in each treatment period|||Participants|||Number
71240|NCT01095250|Secondary|Change in Immunosuppressive Medication Score From Baseline to Week 28|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
71241|NCT01095250|Secondary|Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
71242|NCT01095250|Secondary|Change From Baseline in Quality of Life/Patient Reported Outcome Assessments|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
71243|NCT01095250|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
71244|NCT01095250|Secondary|Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks||||||
71245|NCT01095250|Primary|Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|The results of Study CAIN457C2303 did not meet the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.|||||
71246|NCT01095094|Secondary|Grade 3-5 Toxicity as Assessed by NCI CTC v3.0|Number of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module.|at 6 months from start of treatment|||participants|||Number
71247|NCT01095094|Primary|Progression-free Survival|Number of patients that remained disease free at 6 months from start of treatment.|At 6 months|||participants|||Number
71248|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time|Descriptive statistics for AUC on Study Day 1 and Day 3 for prothrombin time, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis||sec*hour||Standard Deviation|Mean
71249|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa|Descriptive statistics for Area Under the Curve (AUC) on Study Day 1 and Day 3 for Anti-Factor Xa, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis||IU/ml*hour||Standard Deviation|Mean
71250|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time|Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis||sec||Standard Deviation|Mean
71251|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)|Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis.||IU/ml||Standard Deviation|Mean
71252|NCT01094808|Secondary|Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
71253|NCT01094808|Secondary|Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
71254|NCT01094808|Secondary|Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
71255|NCT01094808|Secondary|Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
78231|NCT01018264|Secondary|Number of Nocturia Episodes Per 24 Hour Period|To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity|12 weeks|||Number of nocturia episodes per 24 hours||Standard Deviation|Mean
71256|NCT01094808|Secondary|Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
71257|NCT01094808|Primary|Postprandial Motility Index Over 30 Minutes|The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1]|30 minutes after the meal|||log mm Hg||Standard Deviation|Mean
71258|NCT01094808|Primary|Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)|||Symmetric percentage change||Standard Deviation|Mean
71259|NCT01094808|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|Approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
71260|NCT01094808|Primary|Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure|The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration|||mm||Standard Deviation|Mean
71261|NCT01094808|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration|||mm Hg||Standard Deviation|Mean
71262|NCT01094743|Secondary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting|||units on a scale||Standard Deviation|Mean
71263|NCT01094743|Primary|Subjective Assessment of Quality of Vision|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear|||units on a scale||Standard Deviation|Mean
71264|NCT01094743|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear|||eyes|Participants||Number
71265|NCT01094743|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear|||eyes|Participants||Number
71266|NCT01094743|Primary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear|Completed subjects||units on a scale||Standard Deviation|Mean
71267|NCT01094743|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 1 week of lens wear|All completed subjects||participants|||Number
71268|NCT01094743|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement|after 1 week of lens wear|All completed subjects||eyes|Participants||Number
71269|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 14|The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.||CLUE points||Standard Error|Mean
71270|NCT01094730|Primary|Lens Front Surface Deposits at Day 14|Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.||dichtomized grading scale|Participants|Standard Deviation|Mean
71428|NCT01092416|Secondary|Angiographic Success|Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.|Baseline procedure, with a mean total procedure time of 52.5 minutes.|||Percentage of procedures|||Number
71271|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 7|The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.||CLUE points||Standard Error|Mean
71272|NCT01094730|Primary|Lens Front Surface Deposits at Day 7|Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.||dichotomized grading scale|Participants|Standard Deviation|Mean
71273|NCT01094704|Primary|Change in Average Mucociliary Clearance (0-90 Minutes) at 1 and 4 Hrs Post Dose (MCC4hr - MCCbaseline; MCC1hr - MCCbaseline)|Duration of action of hypertonic saline as determined by measurements of mucociliary clearance/cough clearance 4 hours post dose.|1-4 hours post-dose|ITT||Absolute % change||Standard Deviation|Mean
71274|NCT01094561|Secondary|The Positive Predictive Value of S-MRCP|"The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests.~Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Up to 1 year||||||
71275|NCT01094561|Primary|S-MRCP and S-EUS Concordance|"The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques.~Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Day 1 and up to 30 days after S-MRCP||||||
71276|NCT01094548|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.|From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)|Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.||participants|||Number
71277|NCT01094548|Secondary|Time to Anti-tumor Therapy|Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||months||95% Confidence Interval|Median
71278|NCT01094548|Secondary|Time to Progression (TTP)|Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: >25% increase in the level of serum monoclonal paraprotein (M-protein);>25% increase in the 24 h urinary light chain excretion; >25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||months||95% Confidence Interval|Median
71514|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.|Baseline, Week 57|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 57.||mmol/mmol creatinine||Standard Deviation|Mean
71279|NCT01094548|Secondary|Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR]|OCR (CR, or PR, or MR or NC or PD or NE) was defined per Blade Criteria. OCR rate (CR, or PR, or MR) was defined as the number of participants having experienced at least once a CR, PR, or MR, divided by the number of all participants. CR: negative immunofixation on serum and urine monoclonal paraprotein (M-protein), disappearance of any soft tissue plasmacytomas (STP), <=5% plasma cells in bone marrow (BM); PR: >=50% reduction in serum M-protein, plasma cells in BM, size of STP; >=90% reduction of urinary M-protein in 24 hours, no increase in size/number of the lytic bone lesions (LBL). MR: 25%-49% reduction in serum M-protein, plasma cells in BM aspirate in non-secretory myeloma participants, size of STP; 50%-89% reduction in 24 h urinary light chain reaction (LCR), and no increase in size/number of LBL. PD: >25% increase in the serum M-protein level, 24 hour urinary LCR. Increase in size of existing BL or STP, development of new BL or STP, or development of hypercalcemia|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||Percentage of participants|||Number
71280|NCT01094548|Secondary|Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type|Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. “n” signifies number of participants evaluable for the particular HLA type, respectively.||participants|||Number
71281|NCT01094548|Secondary|Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response|Baseline immune response towards MUC1 was defined as an immune response towards BP25, MUC-A2 or MUC-A11 peptide stimulation which was present in at least one of the two baseline assessments; the specific immune responses at baseline were based on the averaged baseline values across the two baseline visits. Initial increase of MUC1-specific immune response was defined as an increase of MUC1-specific immune response during the primary treatment period (up to Week 9).|Baseline and Week 9|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||participants|||Number
71282|NCT01094548|Primary|Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response|The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon [IFN] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell [PBMC]) with ratio to background >=2, and ratio of background-corrected value to baseline >=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t – Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS[t]=1), upon fulfilling the following criteria: Yt =>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t–1SEM vax,t > AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.||participants|||Number
71283|NCT01093222|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
71284|NCT01093222|Secondary|Objective Response|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients who began protocol therapy||percentage of participants||95% Confidence Interval|Number
71285|NCT01093222|Primary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy||months||95% Confidence Interval|Median
71286|NCT01093222|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy||months||95% Confidence Interval|Median
71287|NCT01094171|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Month 4)|||Subjects|||Number
71288|NCT01094171|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0 - 30) post vaccination period|||Subjects|||Number
71289|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.|During the 4-day (Days 0 - 3) post vaccination period|||Subjects|||Number
71290|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)|During the 4-day (Days 0 - 3) post vaccination period|||Subjects|||Number
71291|NCT01093976|Primary|Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score|The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28.|Subjects were followed for their duration of participation in the study (12-weeks)|Mean score reported below is the endpoint MGH-HPS score (at 12-weeks or last-observation carried forward).||units on a scale||Standard Deviation|Mean
71292|NCT01093846|Primary|The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet’s Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.|The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet’s patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .|62 weeks||||||
71293|NCT01093794|Primary|Cmax for Sitagliptin and Metformin|Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.||ng/mL||Standard Deviation|Mean
71294|NCT01093794|Primary|Area Under the Curve (AUC(0-t)) for Sitagliptin|AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.||hr*ng/mL||Standard Deviation|Mean
71295|NCT01093755|Primary|Change in Esophageal Inflammation Biomarker COX-2 Gene Expression|Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.|3 months, 6 months|||% of tubulin||Standard Deviation|Mean
71296|NCT01093755|Primary|Change in Inflammation Biomarker Tissue PGE2 Level|Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay|3 months, 6 months|||nanograms/gram of tissue||Standard Deviation|Mean
71297|NCT01093690|Secondary|Toxicities and Severity of Nausea and Vomiting||5 days after receiving chemotherapy||||||
71298|NCT01093690|Primary|Number of Patients Who Had Complete Response|number of patients who experience no emesis and need no rescue treatment in 5-day period|5 days after receiving chemotherapy|intention to treat||participants|||Number
71299|NCT01093651|Secondary|Self-reported Symptoms|Cumulative number of self-reported symptoms based on the Division of AIDS Grading Scale for the Severity of Adult Adverse Events (0-4 scale where 0 is no new symptoms, 4 is serious adverse event or toxicity)|Monthly for 4 months|Cumulative frequency over 16 weeks of any self-reported symptoms on the DAIDS scale||total number of self reported symptoms|||Number
71300|NCT01093651|Secondary|Oral Glucose Tolerance|Area under the 75-gr oral glucose tolerance curve (AUCg) based on plasma glucose values measured at 0, 30, 60, 90, and 120 mins post-glucose challenge.|Baseline, week 8, week 16|||mg*min/mL||Standard Deviation|Mean
71301|NCT01093651|Secondary|RANTES; Serum Biomarkers of Immune Activation|serum Regulated on Activation, Normal T cell Expressed and Secreted concentration|Baseline, week 8, week 16|RANTES||ng/mL||Standard Deviation|Mean
71302|NCT01093651|Secondary|SDF1α; Serum Biomarkers of Immune Activation|serum stromal cell-derived factor-1α concentration|Baseline, week 8, week 16|SDF1α||pg/mL||Standard Deviation|Mean
71303|NCT01093651|Secondary|Soluble TNFR2; Serum Biomarkers of Immune Activation|serum soluble tumor necrosis factor receptor-2 concentration|Baseline, week 8, week 16|sTNFR2||pg/mL||Standard Deviation|Mean
71304|NCT01093651|Primary|Plasma HIV Viremia (Viral Load)|Percentage of participants with plasma HIV RNA copy number less than 48 copies/mL|Monthly for 6 months|||percentage of participants below 48 c/mL|||Number
71305|NCT01093651|Primary|CD4+ T-cell Count||Monthly for 4 months|CD4+ T-cell count||cells/µL||Standard Deviation|Mean
71306|NCT01093625|Secondary|Comfortable Wearing Time|Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.||Hours||95% Confidence Interval|Least Squares Mean
71605|NCT01090063|Primary|Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.||16 weeks|Number of participants completing enrollment. Lost values carried forward as last observation carried forward||percentage of participants|||Number
71307|NCT01093625|Primary|Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
71308|NCT01093625|Primary|Corneal Neovascularization|New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
71309|NCT01093625|Primary|Conjunctival Staining|Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
71310|NCT01093625|Primary|Corneal Staining|Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||Efron Scale (0.1 Unit increments)||95% Confidence Interval|Least Squares Mean
71311|NCT01093625|Primary|Limbal Hyperemia|Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
71312|NCT01093625|Primary|Conjunctival Hyperemia|Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
71313|NCT01093625|Primary|Papillary Conjunctivitis|Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.||units on a scale||95% Confidence Interval|Least Squares Mean
71314|NCT01093599|Secondary|Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls||6 months post quit day||||||
71315|NCT01093599|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.|6 months post quit day|intent to treat analysis||participants|||Number
71316|NCT01093534|Secondary|Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'.~Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||percentage of participants|||Number
71317|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.||pg/µmol||Standard Deviation|Mean
71318|NCT01093534|Secondary|Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF); LOCF was used.||pg/µmol||Standard Deviation|Mean
71337|NCT01093534|Secondary|Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF): all randomized participants who received at least 1 dose of randomized study medication, who had given consent for additional analysis and who had an uBDNF/Cr measurement at baseline and on at least 1 visit thereafter. LOCF was used.||pg/µmol||Standard Deviation|Mean
71319|NCT01093534|Secondary|Change From Baseline in Health-Related Quality of Life (HRQL)|"Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from ‘none of the time’ (1) to ‘all of the time’ (6).~The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71320|NCT01093534|Secondary|Change From Baseline in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6).~The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71321|NCT01093534|Secondary|Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale|"The participants’ quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS).~Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71322|NCT01093534|Secondary|Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D|"The participants’ quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform).~Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems.~Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data.||percentage of participants|||Number
71323|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Treatment Satisfaction|The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled ‘No, not at all’ on the left (score = 0) to ‘Yes, completely satisfied’ on the right (score = 100). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71324|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Urgency Bother|"The participants’ perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby ‘no bother at all’ is represented on the left end (score = 0) and ‘worst possible bother’ (score = 100) at the right end of the line.~A negative change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71325|NCT01093534|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71326|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urgency Score|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71338|NCT01093534|Secondary|Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.||pg/µmol||Standard Deviation|Mean
71327|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Level of Urgency|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||units on a scale||Standard Deviation|Mean
71328|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 4 urgency incontinence events at Baseline and with available data; LOCF was used.||urgency incontinence episodes||Standard Deviation|Mean
71329|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 3 or 4 urgency incontinence events at Baseline and with available data; LOCF was used.||urgency incontinence episodes||Standard Deviation|Mean
71330|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set participants with incontinence events at Baseline and with available data; LOCF was used.||incontinence episodes||Standard Deviation|Mean
71331|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours|"An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full Analysis Set participants with urgency micturitions at Baseline and with available data; LOCF was used.||urgency micturitions||Standard Deviation|Mean
71332|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||micturitions||Standard Deviation|Mean
71333|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits."|12 weeks|Full analysis set participants with events at Baseline and with available data; LOCF was used.||urgency events||Standard Deviation|Mean
71334|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours|The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.||events||Standard Deviation|Mean
71335|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline, Week 6 and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data at each time point (indicated by n).||pg/µmol||Standard Deviation|Mean
71336|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline, Week 6 and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data at each time point (indicated by n).||mm||Standard Deviation|Mean
71339|NCT01093534|Primary|Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0): all randomized participants who received at least 1 dose of randomized study medication and who had an uNGF/Cr measurement at Baseline and on at least 1 visit thereafter, excluding participants with Baseline uNGF below or equal to the laboratory quantification limit. LOCF was used.||pg/µmol||Standard Deviation|Mean
71340|NCT01093534|Primary|Change From Baseline to Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT): all randomized participants who received at least 1 dose of randomized study medication and who had a mean BWT measurement at Baseline. Analysis includes participants with available data; Last observation carried forward (LOCF) of post-baseline data was used for imputation of missing values.||mm||Standard Deviation|Mean
71341|NCT01093521|Primary|Number of Events When Study Drug Infusion Was Stopped Early|Tolerability as measured by adverse events of a 5 day continuous infusion of IV Gallium as assessed by stopping study drug infusion|6 days from starting dose|||Number of times study drug interupted|||Number
71342|NCT01093521|Primary|Number of Serious Adverse Events|Safety as measured by serous adverse events|56 days from starting dose|ITT||Serious Adverse Events|||Number
71343|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 56|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 56|56 days from starting dose|All available specimens||colony counts in millions per gm sputum||Standard Deviation|Mean
71344|NCT01093521|Secondary|Change in Sputum P. Aeruginosa Density From Baseline to Day 15|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 15|15 days from starting dose|||colony counts in millions per gm sputum||Standard Deviation|Mean
71345|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 8|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8|8 days from starting dose|All available specimens||colony counts in millions per gm sputum||Standard Deviation|Mean
71346|NCT01093521|Secondary|Change in Spirometry as Measured by FVC From Baseline to Day 8|Change from baseline in lung function assessed by FVC in liters after treatment with IV Ga at day 8|8 days from starting dose|||liters||Standard Deviation|Mean
71347|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 56|Change in lung function as measured by FEV1 in liters from baseline to day 56|56 days from starting dose|all those subjects enrolled after the amendment to add a day 56 (ITT)||liters||Standard Deviation|Mean
71348|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 28|Change in lung function as measured by FEV1 in liters from baseline to day 28|28 days from starting dose|||liters||Standard Deviation|Mean
71349|NCT01093521|Secondary|Change in Lung Function From Baseline to Day 15|Change in FEV1 in liters from baseline to day 15|15 days from starting dose|||liters||Standard Deviation|Mean
71350|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 8|Change in spirometry as measured by FEV1 in liters from baseline to day 8|8 days|ITT||liters||Standard Deviation|Mean
71351|NCT01093521|Primary|Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)|"To assess the summed area under the curves of a 5 day infusion of IV Ga from day 1 to day 28 at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~To assess the safety of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~Safety and tolerability of 5 days of treatment with IV administered gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day."|Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28|||ug*hr/mL||Standard Deviation|Mean
71352|NCT01093417|Secondary|Change in Serum 25-hydroxyvitamin D Concentration in Both Groups||Baseline and 12 weeks|||ng/mL||Inter-Quartile Range|Median
71353|NCT01093417|Primary|Change in Endothelial Function|Endothelial function measured by flow mediated brachial artery dilation|Baseline and 12 weeks|||percent change in endothelial function||Inter-Quartile Range|Median
71354|NCT01093027|Secondary|Tremor Rating Scale|Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.|After 10 minutes of limb cooling treatment.|||units on a scale||Standard Deviation|Mean
71355|NCT01093027|Primary|Tremor Amplitude|Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.|After 10 minutes of limb cooling treatment.|||cm/s^2||Standard Deviation|Mean
71356|NCT01093014|Primary|Skeletal Muscle Gene Expression: PPARGC1A|Messenger ribonucleic acid (mRNA) expression fold-change for peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PPARGC1A). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.||fold-change||Standard Deviation|Mean
71357|NCT01093014|Primary|Skeletal Muscle Gene Regulation: MSTN|Messenger ribonucleic acid (mRNA) expression fold-change for myostatin (MSTN). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.||fold-change||Standard Deviation|Mean
71358|NCT01093014|Primary|LF Muscle Force|Muscle force evoked during low-force muscle stimulation|up to 1 year|||N (newtons)||Standard Deviation|Mean
71359|NCT01093014|Primary|HF Muscle Force|Muscle force evoked during high-force muscle stimulation|up to 1 year|||Newtons (N)||Standard Deviation|Mean
71360|NCT01092923|Primary|PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)|Rate of fall in the end-tidal partial pressure of sevoflurane relative to baseline at 2 minutes (PA2/PA0 sevo) and 5 minutes (PA5/PA0 sevo)|Baseline, 2 minutes, and 5 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.||ratio||Standard Deviation|Mean
71361|NCT01092923|Secondary|Time to Eye Opening|The time to eye opening to command after cessation of inhalational anaesthetic administration|20 Minutes|||Minutes||Standard Deviation|Mean
71362|NCT01092923|Primary|Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)|Rate of fall in the arterial partial pressure of sevoflurane relative to baseline at 2 minutes (Pa 2/Pa0 Sevo), 5 minutes (Pa 5/Pa0 Sevo, and 30 minutes (Pa 30/Pa0 Sevo)|Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.||ratio||Standard Deviation|Mean
71363|NCT01092910|Primary|Assessment of Cochlear Function|Comparison of the bone conduction threshold with forehead placement at the 4 month post-activation follow-up compared to the pre-implant bone conduction threshold.|4 and 10 Months Post-Activation|10-month results for difference in BC PTA (pre-implant minus post-Esteem) are shown||dB difference||Standard Error|Mean
71364|NCT01092910|Primary|SADEs|The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements|10 Months Post-Activation|Includes all events, cumulatively, from enrollment through 10-month followup||events|||Number
71365|NCT01092910|Secondary|Esteem Questionnaire|To gain subject feedback and comments on the use of the Esteem System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem Questionnaire.|4 and 10 Months Post Activatio-||||||
71366|NCT01092910|Secondary|APHAB|To assess whether the Esteem System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB results|4 and 10 Months Post-Activation||||||
71367|NCT01092910|Secondary|QuickSIN|To assess whether the Esteem System is as effective as or better than the pre-implant hearing aid for improving speech discrimination (intelligibility) as shown by the QuickSIN (speech in noise) test results.|4 and 10 Months Post-Activation||||||
71368|NCT01092910|Secondary|PTA Improvement|Comparison of the 3-frequency (500, 1000, and 2000 Hz) pure-tone average (PTA) using the Esteem System to the PTA measured in the baseline unaided condition|4 and 10 Months Post-Activation|10 month data reported||dB improvement||Standard Error|Mean
71369|NCT01092910|Primary|Word Recognition Score Improvement|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|10 Months Post Activation|||improvement in % correct||Standard Error|Mean
71370|NCT01092910|Primary|Word Recognition Score Improvement|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|4 Months Post Activation|||improvement in % correct||Standard Error|Mean
71371|NCT01092910|Primary|SRT Improvement|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|10 Months Post-Activation|||dB improvement||Standard Error|Mean
71372|NCT01092910|Primary|SRT Improvement|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|4 Months Post Activation|||dB improvement||Standard Error|Mean
71373|NCT01092832|Secondary|Time to Death||Baseline up to 1 month follow-up|No participants died within the safety reporting period, therefore time to death was not applicable.|||||
71374|NCT01092832|Secondary|All-Cause Mortality - Number of Participant Deaths||Day 28 and 1 Month Follow-up|Safety population||participants|||Number
71375|NCT01092832|Secondary|Percentage of Participants With a Global Response of Success at End of Treatment (EOT)|Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.|EOT (from 7 to 42 days of treatment)|Modified Intent-to-Treat (MITT) Population: all participants who received at least 1 dose of study medication and who have confirmed ICC, EC or participants with EC who do not have confirmation of EC by esophagoscopy, but who had at least confirmation of oropharyngeal candidiasis.||percentage of participants||95% Confidence Interval|Number
71376|NCT01092832|Primary|Percentage of Participants With Adverse Events - Overall Summary|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.|Baseline up to 1 month follow-up|Safety population||percentage of participants|||Number
71377|NCT01092780|Secondary|Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Meters||90% Confidence Interval|Least Squares Mean
71378|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Minutes||95% Confidence Interval|Least Squares Mean
71606|NCT01090050|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome.|Day 121|||Units on a scale||Standard Deviation|Mean
71379|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Minutes||95% Confidence Interval|Least Squares Mean
71380|NCT01092780|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.|Up to 36 days|All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
71381|NCT01092780|Primary|Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Meters||95% Confidence Interval|Least Squares Mean
71382|NCT01092780|Primary|Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The Per-Protocol (PP) population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.||Minutes||95% Confidence Interval|Least Squares Mean
71383|NCT01092767|Primary|All-cause Mortality Within 30-days of the Index Procedure||30 days|||participants|||Number
71384|NCT01092728|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress.|Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years|None of the participants in the Resectable arm were evaluable, and one participant in the second Unresectable arm was inevaluable due to early departure from study.||Weeks||Full Range|Median
71385|NCT01092728|Primary|Biologic Response Evaluation of Tumors With and Without Resectable Tumors|"Biologic response defined as either (complete or partial) metabolic tumor response after 7 days dasatinib treatment by positron emission tomography (PET) scan, >/= 25% decrease in Fluorodeoxyglucose (FDG) activity on PET without >15% increase in tumoral Ki-67 expression or >/=25% decrease in tumoral Ki-67 expression without >15% increase in FDG activity on PET scan. Complete Metabolic Response (CMR): FDG-avidity all lesions reduced to background FDG-avidity level. Partial Metabolic Response (PMR): >/=25% decrease in FDG-avidity as represented by change in mean Standardized Uptake Values (SUV) max. SUVmax measured by drawing region of interest slightly outside each lesion corresponding to those on CT image & adjusted for body weight. Measureable disease by PET scan defined as lesions that can be determined to have FDG-avidity of SUVmax of 3 and 2 x background.~PR or CR confirmatory disease assessment performed >4 weeks (28 days) after criteria for response first met."|Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards|Of 4 participants in first arm, none were evaluable for response (1 inevaluable, 2 withdrawals, 1 disease progression); and of the second arm, one was inevaluable (withdrawal).||participants|||Number
71386|NCT01092702|Primary|Biochemically Confirmed Abstinence From Smoking|The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.|12 weeks from start of medication|||participants|||Number
71387|NCT01092663|Secondary|Postprandial Glucagon (AUC)|To evaluate the effects of treatment on postprandial glucagon (AUC)|Baseline and 12 weeks|||picograms (pg)/milliter (ml) x min||Standard Deviation|Mean
71388|NCT01092663|Secondary|Postprandial Total GIP (AUC)|To evaluate the effects of treatment on postprandial total GIP (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
71389|NCT01092663|Secondary|Postprandial Active GLP-1 (AUC)|To evaluate the effects of treatments on postprandial active GLP-1 (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
71390|NCT01092663|Secondary|Postprandial C-peptide (AUC)|To evaluate the effect of treatments on postprandial C-peptide (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
71391|NCT01092663|Secondary|Postprandial Insulin (AUC)|To evaluate the effect of treatments on postprandial insulin (AUC)|Baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
71392|NCT01092663|Secondary|Fasting Insulin|To evaluate the effect of treatments on fasting insulin concentrations|Baseline and 12 weeks|||pmol/L||Standard Deviation|Mean
71393|NCT01092663|Primary|Postprandial Glucose (AUC)|Comparison between baseline and 12 weeks values of postrandial glucose (AUC).|Baseline and 12 weeks|||millimoles (mmol)/l x min||Standard Deviation|Mean
71394|NCT01092663|Primary|Whole-body Glycolytic Disposal of Oral Glucose|Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments|baseline and 12 weeks|||Percent of Load||Standard Deviation|Mean
71395|NCT01092663|Primary|Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)|"Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments~AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test."|baseline and 12 weeks|||umol per kg per min||Standard Deviation|Mean
71396|NCT01092663|Primary|Postprandial Endogenous Glucose Production|"Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments~Mean value was calculated using all results measured between 10 and 300 min post meal."|baseline and 12 weeks|||umol per kg per min||Standard Deviation|Mean
71397|NCT01092663|Primary|Appearance Rate of Oral Glucose|Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments|baseline and 12 weeks|||umol per kg per min||Standard Deviation|Mean
71398|NCT01092663|Primary|Fasting Plasma Glucose Clearance|Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.|baseline and 12 weeks|||ml per kg FFM per minute (min)||Standard Deviation|Mean
71399|NCT01092663|Primary|Fasting Glycogenolysis|Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks|||umol per kg Fat-Free Mass (FFM) per min||Standard Deviation|Mean
71400|NCT01092663|Primary|Fasting Gluconeogenesis|Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks|||umol per kilogram (kg) FFM per min||Standard Deviation|Mean
71401|NCT01092663|Primary|Fasting Endogenous Glucose Production|Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks|||micromoles (umol) per kg FFM per min||Standard Deviation|Mean
71402|NCT01092663|Secondary|Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)|To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.|Baseline and 12 weeks|||pmol/L||Standard Deviation|Mean
71403|NCT01092663|Secondary|Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)|To evaluate the effect of treatments on plasma GLP-1 concentrations.|Baseline and 12 weeks|||pmol/L||Standard Deviation|Mean
71404|NCT01092663|Secondary|Fasting Plamsa Glucagon|To evaluate the effect of treatments on plasma glucagon concentrations.|Baseline and 12 weeks|||picograms (pg)/milliliter (ml)||Standard Deviation|Mean
71405|NCT01092663|Primary|Fasting Plasma Glucose|Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.|Baseline and 12 weeks|||millimoles (mmol)/Liter (L)||Standard Deviation|Mean
71406|NCT01092663|Secondary|Fasting Plasma C-peptide|To evaluate the effect of treatments on plamsa C-peptide concentrations.|Baseline and 12 weeks|||picomoles (pmol)/Liter (L)||Standard Deviation|Mean
71407|NCT01092663|Primary|Hemoglobin A1C|Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments|Baseline and 12 weeks|||percentage||Standard Deviation|Mean
71408|NCT01092637|Secondary|Number of Survivors With Cerebral Palsy|Number of participants diagnosed with Cerebral Palsy|7 years 3 months|Number of participants with cerebral palsy||participants|||Number
71409|NCT01092637|Secondary|Number of Survivors Without Disability|IQ =>85, no neurological abnormalities, normal hearing, normal vision|7 years 3 months|Number of participants without disability. Two particpants in the cooled group and three in the non-cooled group could not be classified.||participants|||Number
71410|NCT01092637|Primary|Number of Survivors With an IQ > 84|IQ was measured using WPPSI III core tests|7 years 3 months|Children for whom IQ data at age 6-7 yr were available||participants|||Number
71411|NCT01092559|Primary|Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation||through Treatment Period|||participants|||Number
71412|NCT01092559|Primary|Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.|"Adverse Event Severity [through Day 30 Follow-Up Period]~Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms [through discharge from Treatment Period]~Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin.~[through discharge from Treatment Period]~Vital Signs: pulse, blood pressure, respiratory rate [through discharge from Treatment Period]"|through Day 30 Follow-up Period|||participants|||Number
71413|NCT01092546|Secondary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Pons as the Reference Region."|The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.|Post flutemetamol administration|"The correlation coefficient listed in the table is between SUVR-Pons and the percent area of Amyloid.~Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the Pons as the reference region."||Correlation Coefficient of the site|||Number
71414|NCT01092546|Primary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Cerebellum (CER) as the Reference Region."|The level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.|Post flutemetamol Injection|"The correlation coefficient listed in the table is between SUVR-CER and the percent area of Amyloid.~Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the cerebullum (CER) as the reference region."||Correlation Coefficient of the Site|||Number
71426|NCT01092416|Secondary|12-Month Freedom From Major Adverse Cardiac Events (MACE)|The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.|12 months|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 12 months.||Percent probability of Freedom from MACE||95% Confidence Interval|Number
71415|NCT01092507|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)|"Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.~Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature > 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable."|Day 0 through Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population).||Participants|||Number
71416|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set)||Titers||95% Confidence Interval|Geometric Mean
71417|NCT01092507|Secondary|Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set)||Participants|||Number
71418|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Titers||95% Confidence Interval|Geometric Mean
71419|NCT01092507|Secondary|Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination."|Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Participants|||Number
71420|NCT01092507|Secondary|Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 post-vaccination|Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Participants|||Number
71421|NCT01092507|Primary|Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50).~Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination."|Day 0 through Day 28 after vaccination|Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)||Participants|||Number
71422|NCT01092442|Primary|Safety Assessment|"Evaluation of the following adverse events~Mortality (all cause and valve-related)~Reoperation/reintervention~Explant~Endocarditis~Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency)~Thrombosis~Thromboembolism (pulmonary embolism)~Non-structural dysfunction~Perivalvular leak~Bleeding~Hemolysis~Calcification"|Since Implant of the Valve to a Maximum of 13.0 years|||percentage of patients|||Number
71423|NCT01092442|Primary|Hemodynamic Performance|Pulmonary Insufficiency Grade|Most Recent Follow-up (average of 4 to 6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.||participants|||Number
71424|NCT01092442|Primary|Hemodynamic Performance|Peak Pulmonary Gradient Mean Pulmonary Gradient|Most Recent follow-up (average of 3-6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.||mmHg||Standard Deviation|Mean
71425|NCT01092416|Primary|Primary Efficacy Endpoint: Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.|||Percentage of procedures||95% Confidence Interval|Number
78317|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 2|Cmax was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Cycle 2 (predose and 1.25 hours postdose)|No participants were analyzed.|||||
71429|NCT01092416|Primary|Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)|"OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of:~Cardiac death.~MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave.~TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure."|30 days|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.||Percent probability of Freedom from MACE||95% Confidence Interval|Number
71430|NCT01092338|Primary|Efficacy of the Two Doses (4000 and 7000 IU/d)|Daily D3 supplementation will result in 25D >= to 32/ng/ml|12 weeks|Number of subjects with serum 25D concentration levels >= 32 ng/ml after 12 weeks of supplementation.||participants|||Number
71431|NCT01092338|Primary|Safety|Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml).|12 weeks|Number of subjects with elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml)||participants|||Number
71432|NCT01091974|Secondary|Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .|The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue “now,” and fatigue at its “worst” and “usual” for the last 24 hours. The 11-point scales are bounded by 0 = “no fatigue” and 10 = “fatigue as bad as you can imagine.” Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = “does not interfere” and 10 = “interferes completely.” A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).|Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.||units on a scale||Standard Error|Mean
71433|NCT01091974|Primary|Change in Insomnia Severity Index From Baseline to Post-intervention|The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).|||units on a scale||Standard Error|Mean
71434|NCT01091948|Secondary|Number of Intubation Attempts||from start of intubation to successfully intubated|||participants|||Number
71435|NCT01091948|Secondary|Sore Throat Grade||On the first postoperative day|This outcome was not collected for 1 patient in each group.||participants|||Number
71436|NCT01091948|Secondary|Trace Bleeding|Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube|Right after intubation|||participants|||Number
71437|NCT01091948|Secondary|Occurrence of Hypoxaemia|Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.|at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after|||participants|||Number
71438|NCT01091948|Secondary|Successful Intubation on 1st Attempt||from start of first intubation to end of first intubation attempt|||participants|||Number
71439|NCT01091948|Secondary|Intubation Difficulty Score|Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);|from start of intubation to successfully intubated|||units on a scale||Inter-Quartile Range|Median
71440|NCT01091948|Primary|Time to Intubation (TTI) as Measured in Seconds|Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).|from start of intubation to successfully intubated up to 100 seconds|||seconds||Inter-Quartile Range|Median
71441|NCT01091675|Primary|the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined|"BASDAI Bath Ankylosing Spondylitis Disease Activity Index, is the gold standard for measuring and evaluating disease activity in Ankylosing Spondylitis consists of a one through 10 scale which is used to answer 6 questions pertaining to the 5 major symptoms of AS.~BASDAI has been used to assess the efficacy of the treatment. Possible Patients were considerate respond to ASABIO criteria when presented a change of 2 in the BASDAI score range."|the ASAS response were evaluated at week 2 and 4 and after 6 months treatment|Patients with physician-diagnosed Ankylosing Spondylitis at 6 months before study start||percentage of participants||95% Confidence Interval|Number
71442|NCT01091662|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Double-blind: week to 18; Baseline: weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 54; Baseline: 54; Titration: 54; AED taper/conversion; 54; Monotherapy: 48 (ESL 1600 mg) Double-blind: 100; Baseline: 98; Titration: 100; AED taper/conversion; 100; Monotherapy: 88||seizures in 28 days||Standard Deviation|Mean
71443|NCT01091662|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population||Percent of particiants|||Number
71444|NCT01091662|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L.|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Week 0 to Week 18|ITT population||percentage of participants|||Number
71445|NCT01091662|Secondary|Proportion (%) of Subjects With Increase of Body Weight >= 7% From Baseline||18 Week Double-blind treatment period|ITT population||percentage of participants|||Number
75233|NCT01054729|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.|Week 4|Safety Analysis Set||percentage of participants|||Number
71446|NCT01091662|Secondary|Change in Total Score of MADRS From Baseline in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, higher score indicates more severe|Week 0 to Week 18, baseline:day 0;end of AED taper/conversion period; end of week 8; end of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 7; Change from baseline to end of monotherapy period: 7 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 16; Change from baseline to end of monotherapy period: 18||units on a scale||Standard Deviation|Mean
71447|NCT01091662|Secondary|Change in Total Score in Montgomery-Asberg Depression Rating Scale (MADRS),From Baseline .|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, high score indicates more severe|Week 0 to Week 18,baseline day 0; end of AED taper/conversion period; end of week 8; end of monotherapy period; end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 48; Change from baseline to end of monotherapy period: 54 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 88; Change from baseline to end of monotherapy period: 98||units on a scale||Standard Deviation|Mean
71448|NCT01091662|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, Baseline: Day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period:50 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 85; Change from baseline to end of monotherapy period:96||units on a scale||Standard Deviation|Mean
71449|NCT01091662|Secondary|Proportion (%) of Subjects Reaching Each Exit Criteria|"The proportion (%) of subjects reaching each of the 5 exit criteria-1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.~5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|Week 1 to Week 18, (beginning of week 1 to end of week 18)|Efficacy population||percentage of participants|||Number
71450|NCT01091662|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double-blind weeks 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18|Efficacy population||percentage of participants||95% Confidence Interval|Number
71451|NCT01091662|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy; weeks 9 to 18|Efficacy population (ESL 1200mg) Double-blind: 54; Titration: 54; AED taper/conversion:54; Monotherapy: 48 (ESL1600 mg) Double-blind:98; Titration: 98; AED taper/conversion: 98; Monotherapy: 87||Percent change||Inter-Quartile Range|Median
71452|NCT01091662|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|Efficacy population||days||95% Confidence Interval|Median
71453|NCT01091662|Secondary|Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete).|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Week 8 through 18|Efficacy population||percentage of participants||95% Confidence Interval|Number
71454|NCT01091662|Secondary|Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment).|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|18 weeks|Efficacy population||percentage of participants||95% Confidence Interval|Number
71455|NCT01091662|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Percentage of participants that were Seizure-free during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Week 15 through 18|Efficacy population||percentage of participants||95% Confidence Interval|Number
71456|NCT01091662|Secondary|Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Week 9 through 18|Efficacy population||percentage of participants||95% Confidence Interval|Number
71466|NCT01091259|Primary|Progression Free Survival (PFS) Rate at 6 Months|The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.|6 months from the start of treatment|Intent-to-treat population.||percentage of patients||95% Confidence Interval|Number
71457|NCT01091662|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|"Cumulative exit rate was defined as the proportion of subjects meeting at least one of the following five exit criteria over a 16-week study period (from start of AED taper/con. period (Wk 3) to end of double blind monotherapy period (Wk 18)).1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.~5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|From beginning of Week 3 to end of Week 18|Efficacy population||proportion of participants||95% Confidence Interval|Number
71458|NCT01091519|Secondary|Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4|Participant’s response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5–point scale, participant was asked: “overall how satisfied are you with your over active bladder (OAB) medication?” 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2).|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||participants|||Number
71459|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4|PPUS: single-item, self-administered validated questionnaire. Rated on a 3–point scale: participant was asked: “Which of the following would typically describe your experience when you have a desire to urinate?” 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||participants|||Number
71460|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4|"PPBC: single-item, self-administered validated questionnaire. Rated on a 6–point scale: participant was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2)."|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.||participants|||Number
71461|NCT01091519|Primary|Percentage of Participants Satisfied With Treatment at Month 4|Participant’s response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: “overall, how satisfied are you with your OAB medication?” and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including “very satisfied” and “somewhat satisfied”) and dissatisfied (including “very dissatisfied”, “somewhat dissatisfied”, and “neither dissatisfied nor satisfied”).|Month 4|Full Analysis Set (FAS) included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
71462|NCT01091259|Secondary|Number of Patients Who Experienced Grade 3 and Higher Toxicities||up to 3 years|Any patients who had at least one dose of treatment||participants|||Number
71463|NCT01091259|Secondary|Median Overall Survival|Defined as the length of time from the start of treatment that half of the patients are still alive.|up to 3 years|Intent-to-treat||months||95% Confidence Interval|Median
71464|NCT01091259|Secondary|Median Progression Free Survival|Defined as the length of time from the start of treatment that half of the patients are still alive and without disease progression. Progression is evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range; progression is defined on the basis of a confirmed doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level)|up to 3 years|Intent-to-treat||months||95% Confidence Interval|Median
71465|NCT01091259|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of all patients with confirmed partial response (PR) or complete response (CR). PR and CR are evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range).|up to 3 years|Intent-to-treat population||percentage of patients||95% Confidence Interval|Number
71467|NCT01091246|Secondary|Percent of All Participants Reporting Any New Onset Chronic Disease (NOCD) From Administration of Investigational Product Through 180 Days Post Last Dose|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of participants|||Number
75234|NCT01054729|Secondary|Change in Circulating HCV RNA at Week 4||Baseline to Week 4|Safety Analysis Set||log10 IU/mL||Standard Deviation|Mean
71468|NCT01091246|Secondary|Percent of All Participants Reporting Any SAE From Administration of Investigational Product Through 180 Days Post Last Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of participants|||Number
71469|NCT01091246|Secondary|Percent of Two-dose Participants Reporting Any SAE From Administration of Dose 2 During Days 0-28 Post Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summarized period (Q=1041; All FM=693).||Percent of participants|||Number
71470|NCT01091246|Secondary|Percent of All Participants Reporting Any Serious Adverse Event (SAE) From Administration of Investigational Product Through Day 28 Post Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of participants|||Number
71471|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Dose 2 Through 28 Days Post Dose 2|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summariezed period (Q=1041; All FM=693).||Percent of participants|||Number
71472|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any safety data were recorded during the summarized period (Q=1083; All FM=719).||Percent of Participants|||Number
71473|NCT01091246|Secondary|Percent of All Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).||Percent of Participants|||Number
71474|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Dose 2 During Days 0-14 Post Dose 2|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1039; All FM=692).||Percent of Participants|||Number
71475|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1078; All FM=716).||Percent of Participants|||Number
71488|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).||Percent of participants|||Number
71476|NCT01091246|Secondary|Percent of All Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1377; All FM=920).||Percent of Participants|||Number
71477|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).||Percent of Participants|||Number
71478|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).||Percent of participants|||Number
71479|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=364; All FM=244).||Percent of participants|||Number
71480|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=460; All FM=321).||Percent of participants|||Number
71481|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).||Percent of participants|||Number
71482|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).||Percent of participants|||Number
71483|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).||Percent of participants|||Number
71484|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).||Percent of participants|||Number
71485|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FV=437).||Percent of participants|||Number
71486|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445).||Percent of participants|||Number
71487|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved an A/H1N1 or A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; All FM=883).||Percent of participants|||Number
71513|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.|Baseline, Week 65|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 65.||mmol/mmol creatinine||Standard Deviation|Mean
71489|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).||Percent of participants|||Number
71490|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=364; All FM=244).||Percent of participants|||Number
71491|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=460; All FM=321).||Percent of participants|||Number
71492|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).||Percent of participants|||Number
71493|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).||Percent of participants|||Number
71494|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).||Percent of participants|||Number
71495|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).||Percent of participants|||Number
71496|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FV=437).||Percent of participants|||Number
71497|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FY=441).||Percent of participants|||Number
71498|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; All FM=879).||Percent of participants|||Number
71499|NCT01091246|Secondary|The Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1320; All FM=878).||percent of participants|||Number
71500|NCT01091246|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains. .|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464; FV=463; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445; FV=437; All FM=883).||Geometric mean titer||Full Range|Geometric Mean
71501|NCT01091155|Primary|Device Related Leak Rate up to 30 Days Post op|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|30 days post op|||participants|||Number
71502|NCT01091155|Secondary|Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.|"The post operative parameters that will be measured during hospitalization period:~Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home~First day to first postoperative flatus~First day to first postoperative bowel movements~First day of first postoperative toleration of liquids and solids (time to keeping them down)"|30 days post op||||||
71503|NCT01091155|Primary|To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|Approx. 1 year||||||
71504|NCT01091116|Secondary|Clinically Significant Abnormal Laboratory Tests|"Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators.~The following hematochemical and urinary parameters were analysed:~Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin."|up to 4 months from screening|Percentage of patients with clinically significant abnormal laboratory tests||participants|||Number
71505|NCT01091116|Secondary|Adverse Event Reports|Incidence of spontaneously reported adverse events|up to 4 months after screening|The number of patients reflects all patients administered at least one dose of the investigational product.||participants|||Number
71506|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]|"Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Over Weight patients (BMI >25)||mm||Standard Deviation|Mean
71507|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]|"Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Normal Weight patients (BMI <=25)||mm||Standard Deviation|Mean
71508|NCT01091116|Secondary|Patient Global Assessment|"Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm).~Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0).~A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms."|up to 3 months after first dose|intention to treat (ITT) population||mm||Standard Deviation|Mean
71509|NCT01091116|Secondary|Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria|"Osteoarthritis Research Society International (OARSI).~Response defined as:~a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale~OR if two of the following three findings are recorded:~a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient’s global assessment by 20% or more and by 10 or more points on the scale."|up to 3 months after first dose|intention to treat (ITT) population||percentage of patients|||Number
71510|NCT01091116|Secondary|WOMAC VA 3.1. C Score (Function)|"Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours.~The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty).~A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities.~WOMAC VA 3.1.C scores at baseline and at Week 13 are reported."|up to 3 months after first dose|Intention to Treat (ITT) population||mm||Standard Deviation|Mean
71511|NCT01091116|Secondary|WOMAC VA 3.1.B Score (Knee Stiffness)|"WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness).~A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness.~The change at Week 13 from baseline is reported."|up to 3 months after first dose|Intention to Treat (ITT) population||mm||Standard Deviation|Mean
71512|NCT01091116|Primary|WOMAC VA 3.1 A Score (Total Pain)|"Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours.~The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain).~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.~The change from baseline was assessed along 3 weeks after first drug administrations."|over the 3 weeks after the first administration|analysis of the intention to treat (ITT) population||mm||Standard Deviation|Mean
71515|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.|Baseline, Week 49|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 49.||mmol/mmol creatinine||Standard Deviation|Mean
71516|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.|Baseline, Week 41|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 41.||mmol/mmol creatinine||Standard Deviation|Mean
71517|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide||Baseline, Week 33|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 33.||mmol/mmol creatinine||Standard Deviation|Mean
71518|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.|Baseline, Week 25|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 25.||mmol/mmol creatinine||Standard Deviation|Mean
71519|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.|Baseline, Week 17|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 17.||mmol/mmol creatinine||Standard Deviation|Mean
71520|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.|Baseline, Week 9|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 9.||mmol/mmol creatinine||Standard Deviation|Mean
71521|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.|Baseline, Week 5|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 5.||mmol/mmol creatinine||Standard Deviation|Mean
71522|NCT01091103|Secondary|Median Time to Study Drug Discontinuation|Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.|Duration of study treatment through the data cutoff date|All participants who received any amount of enzalutamide. Fifteen (25.0%) participants were still on study drug as of the data cutoff date and were censored at the data cutoff date.||months||95% Confidence Interval|Median
71523|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.~Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.~The change from baseline in bone marrow dihyrdrotestosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
71524|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.~Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.~The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
71525|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.~Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
71526|NCT01091103|Secondary|Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)|Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.|Baseline, Week 9|Participants who received any amount of enzalutamide and had PSA values at baseline and at the Week 9 Visit.||percentage of participants||95% Confidence Interval|Number
71527|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.~Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.||ng/mL||Standard Deviation|Mean
71528|NCT01090973|Secondary|Number of Participants With Adverse Events (AEs)|"Investigators intended to evaluate the safety and tolerability profile of LBH589. Assessments would consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, vital signs, ECOG performance status, and the regular physical examinations and ECG assessments.~Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. CTCAE v3.0 can be accessed on the National Institute of Health (NIH)/NCI website at http://ctep.cancer.gov/forms/CTCAEv3.pdf."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||participants|||Number
71529|NCT01090973|Secondary|Number of Participants With Improved Blood and Lymphatic Evaluation Results|Investigators intended to evaluate histone acetylation, cytotoxic mixed lymphocyte reaction (MLR) activity, cytokine profiles, and immunologic synapse alterations through peripheral blood correlative studies|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
71530|NCT01090973|Secondary|Number of Participants With Prolonged Corrected QT (QTc) Interval|Investigators intended to monitor the QTc interval in patients receiving oral LBH589|8 weeks (2 cycles) unless treatment continues due to partial or complete response||||||
71531|NCT01090973|Secondary|Progression Free Survival (PFS) Estimate|Investigators intended to estimate the progression free survival time|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
71532|NCT01090973|Secondary|Response Duration|Investigators intended to determine the duration of responses.|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
71533|NCT01090973|Secondary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Investigators intended to determine the complete and partial responses. Chronic Lymphocytic Leukemia (CLL): Using the NCI criteria - - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.~Mantle Cell Lymphoma (MCL): Based on the International Workshop to Standardize Response Criteria to NHL (Cheson, JCO 1999) - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
71534|NCT01090973|Primary|Number of Participants With Desired Response|"Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).~WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed <50% of normal daytime; 3 Needs to be in bed >50% of normal daytime; 4 Unable to get out of bed."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||||
71535|NCT01090765|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|43 months, 5 days|||participants|||Number
71536|NCT01090765|Primary|Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.|The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.|6 months|||mg/kg every 2 weeks|||Number
71537|NCT01090752|Secondary|Effects of Pioglitazone on Salt Sensitivity||2009||06/2010||||
71538|NCT01090752|Primary|Effects of Pioglitazone on 24h Blood Pressure Control|24 hour blood pressure measurements were performed after each treatment/diet phase|march 2009|||mmHg||Standard Error|Mean
71539|NCT01090752|Primary|Effects of Pioglitazone on Sodium and Lithium Clearances|At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances|2007|||ml/min||Standard Error|Mean
71540|NCT01090752|Primary|Effects of Pioglitazone on Renal Hemodynamics|At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF|2008|||ml/min/1.73m2||Standard Error|Mean
71541|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Physician Visits Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects||physician visits||Standard Deviation|Mean
71542|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects||days||Standard Deviation|Mean
71543|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Pads Per Day Subject Took for FI|Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI|36 Month Follow-up Visit|All implanted subjects||pads per day||Standard Deviation|Mean
71544|NCT01090739|Other Pre-specified|Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)|The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better|36 Month Follow-up Visit|All implanted subjects||units on a scale||Standard Deviation|Mean
71545|NCT01090739|Secondary|Change in Numeric Pelvic Pain Scale (NPPS)|Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.|12 Month Follow-up Visit|All subjects implanted at the time the NPPS was implemented in the study||units on a scale||Standard Deviation|Mean
71546|NCT01090739|Secondary|Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)|Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
71547|NCT01090739|Secondary|Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores|"Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).~The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score."|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
71548|NCT01090739|Secondary|Change in Pelvic Floor Distress Inventory (PFDI-20) Scores|"Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).~The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale."|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
71549|NCT01090739|Secondary|Change in Fecal Incontinence Quality of Life Score|Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
71550|NCT01090739|Secondary|Change in Wexner Symptom Severity Score|Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.|36 Month Follow-up Visit|All subjects implanted||units on a scale||Standard Deviation|Mean
71551|NCT01090739|Secondary|Change in Urge Fecal Incontinence Episodes|Number of urge fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted||urge fecal incontinent episodes/14 days||Full Range|Median
71552|NCT01090739|Secondary|Change in Fecal Incontinence Days|Number of fecal incontinence days in a 14 day period|36 Month Follow-up Visit|All subjects implanted||fecal incontinent days/14 days||Full Range|Median
71553|NCT01090739|Secondary|Change in Fecal Incontinence Episodes|Number of fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted||fecal incontinent episodes/14 days||Full Range|Median
71554|NCT01090739|Primary|Percentage of Responders|The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.|12 Months|All subjects implanted||percentage of treatment responders||95% Confidence Interval|Number
71555|NCT01090479|Secondary|Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery||7 days||||||
71556|NCT01090479|Primary|Number of Patients With a Clinically Diagnosed Infection||2 months post-operatively|||participants|||Number
71557|NCT01090453|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Subjects|||Number
71558|NCT01090453|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.||Subjects|||Number
71559|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.||Subjects|||Number
71560|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.||Subjects|||Number
71561|NCT01090453|Secondary|Anti-PRP and rSBA-MenC Fold Increase Distribution.|The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71562|NCT01090453|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||µg/mL||95% Confidence Interval|Geometric Mean
71563|NCT01090453|Secondary|Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.|The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71564|NCT01090453|Secondary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Sujects|||Number
71565|NCT01090453|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||EL.U/mL||95% Confidence Interval|Geometric Mean
71566|NCT01090453|Secondary|Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.|The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71567|NCT01090453|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||titers||95% Confidence Interval|Geometric Mean
71568|NCT01090453|Secondary|Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.|The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71569|NCT01090453|Primary|Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibodies Above the Cut-offs.|The rSBA-MenC cut-offs were ≥ 1:8 and ≥ 1:128. The results for Month 3 ≥ 1:8 were the primary efficacy variables.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71570|NCT01090453|Secondary|Concentrations for Anti-HBs.|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||mIU/mL||95% Confidence Interval|Geometric Mean
71655|NCT01089556|Other Pre-specified|Mean Change in Heart Rate From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline heart rate measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
71571|NCT01090453|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71572|NCT01090453|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||IU/mL||95% Confidence Interval|Geometric Mean
71573|NCT01090453|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.|The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71574|NCT01090453|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||titers||95% Confidence Interval|Geometric Mean
71575|NCT01090453|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||µg/mL||95% Confidence Interval|Geometric Mean
71576|NCT01090453|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-offs.|The anti-PRP antibody concentrations cut-off was ≥ 0.15 and ≥ 1.0 micrograms per milliliter (µg/mL). The results for Month 3 ≥ 0.15 µg/mL were the primary efficacy variables.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.||Subjects|||Number
71577|NCT01090427|Secondary|The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1||Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.||Percentage of participants|||Number
71578|NCT01090427|Secondary|The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12|The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.||Scores on a scale||Standard Deviation|Mean
71579|NCT01090427|Secondary|The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.||Percentage of participants|||Number
71580|NCT01090427|Secondary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12|The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.||Percentage of participants|||Number
92755|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])||Baseline up to Month 7|||percentage of participants|||Number
71581|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.|Week 12|The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.||Percentage of Participants|||Number
71582|NCT01090427|Secondary|Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child’s quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.|Baseline; Week 12|Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.||Scores on a scale||Standard Deviation|Mean
71583|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.|Week 12|The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.||Percentage of Participants|||Number
71584|NCT01090427|Primary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.|Week 12|The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.||Percentage of Participants|||Number
71585|NCT01090323|Secondary|Change in Serum Ferritin From Start of ICL670 to End of Study|The main efficacy variable was change in serum ferritin in response to therapy with ICL670. Due to variability of serum ferritin, end of study was considered as the mean of at most the last 3 available observations after the start of ICL670.|0 - 60 months|The primary analysis was on Full Analysis Set which comprised all participants who received at least one dose of ICL670 during the core or the extension phase of the study. All participants previously treated with ICL670 or DFO for 52 weeks in the core study were eligible for enrollment.||µg/L||Full Range|Median
71586|NCT01090323|Primary|Number of Participants With Adverse Events After Start of ICL670|Safety as assessed by the number of participants with adverse event or death after the start of ICL670.|0 - 60 months|The primary analysis was on Safety Analysis Set which comprised all participants who received at least one dose of ICL670 during the core/extension phase of the study. All participants previously treated with ICL670/DFO for 52weeks in the core study.||participants|||Number
71587|NCT01090310|Secondary|Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension|IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Units on a scale||Standard Deviation|Mean
71588|NCT01090310|Secondary|Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies|Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Number of participants|||Number
71589|NCT01090310|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Letters||Standard Deviation|Mean
71590|NCT01090310|Secondary|Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Number of participants|||Number
71591|NCT01090310|Primary|The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization||Days||95% Confidence Interval|Median
71592|NCT01090180|Secondary|Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe|The QIDS-SR is a 16-item measure of depression symptom severity with a range from 0-27. Each item is rated from 0-3 with higher scores are indicative of higher symptom severity. Scores of the items are aggregated (with the highest score on overlapping items chosen; e.g., sleep disturbances, changes in eating) to generate the total score..|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.|||units on a scale||Standard Deviation|Mean
71593|NCT01090180|Primary|PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period|The PCL is a 17-item measure of PTSD symptom severity with a range from 17-85. Each item is rated from 1-5 with higher scores are indicative of higher symptom severity. Scores of the 17 items are summed in order to generate the total score.|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.|Male veterans with combat-related PTSD||units on a scale||Standard Deviation|Mean
71594|NCT01090102|Secondary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover|Log(10) change in the percentage of activated T cells during the second 12 weeks of the study|Week 12, Week 24|||Log10(percentage of T cells)||95% Confidence Interval|Mean
71595|NCT01090102|Primary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study||Week 0, Week 12|1 participant assigned to first receive Mesalamine was excluded from analysis due to having withdrawn participation without receiving the allocated intervention||Log10(percentage of T cells)||95% Confidence Interval|Mean
71596|NCT01090076|Primary|% Wound Area Week 2|Percentage change in wound area after week 2|Weeks 1 to 2|||Percentage change||Standard Error|Mean
71597|NCT01090076|Primary|% Wound Area Week 1|Percentage change in wound area after week 1|week 0 to 1|||percent change||Standard Error|Mean
71598|NCT01090076|Primary|% Viable Tissue|"-Percentage viable tissue after 2 weeks~The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue."|weeks 1 to 2|||Percentage of viable tissue||Standard Error|Mean
71599|NCT01090063|Secondary|Safety Outcome Measures|All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends.|24 weeks|All participants who enrolled. Participants terminating prior to week 24 had their data carried forward as lost to follow-up.||participants|||Number
71600|NCT01090063|Secondary|Pain Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how much pain are you experiencing from your disease of your hands and feet, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||units on a scale||Standard Deviation|Mean
71601|NCT01090063|Secondary|Pruritus Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how itchy are you, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||units on a scale||Standard Deviation|Mean
71602|NCT01090063|Secondary|Fissure Count (if Present at Baseline) From Baseline to Week 24|Number of discrete fissures on the hands and feet of each subject.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||fissures||Standard Deviation|Mean
71603|NCT01090063|Secondary|Pustule Count (if Present at Baseline) From Baseline to Week 24|Number of pustules present in each subject|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||pustules||Standard Deviation|Mean
71604|NCT01090063|Secondary|PGA Score Over Time From Baseline to Week 24|Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.||units on a scale||Full Range|Median
71607|NCT01090050|Secondary|Migraine Disability Assessment(MIDAS)Questionnaire Total Score|"Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study at Day 121.|||scores on a scale||Standard Deviation|Mean
71608|NCT01090050|Secondary|Percent Change of Doses of Study Medication|"Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.|||percent doses of study medication||Standard Deviation|Mean
71609|NCT01090050|Secondary|Migraine Headache Days With Greater Than 50% Reduction|Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.|||participants|||Number
71610|NCT01090050|Secondary|Migraine Headache Duration From Time of Treatment to Pain Free|"Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.|||percent hours of migraine duration||Standard Deviation|Mean
71611|NCT01090050|Secondary|Migraine Headache Duration From Onset to Pain Free|"Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.|||percent hours of migraine duration||Standard Deviation|Mean
71612|NCT01090050|Secondary|Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline|"Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation.~e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)"|Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.|||percent migraine headache days per month||Standard Deviation|Mean
71613|NCT01090050|Primary|Percent Change of Migraine Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)|Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.|||percent migraine headache days per month||Standard Deviation|Mean
71614|NCT01090011|Secondary|Progression-Free Survival (PFS) Time|Progression-Free Survival was defined as the duration of time from start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to RECIST 1.1) or death.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||months||95% Confidence Interval|Median
71615|NCT01090011|Secondary|Duration of Disease Control (According to RECIST v1.1)|Duration of disease control was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence SD, PR or CR.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||months||Standard Deviation|Mean
71630|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Dose Reduction||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
71616|NCT01090011|Secondary|Duration of Objective Response (According to RECIST v1.1)|Duration of objective response was measured from the time measurements criteria were met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since treatment started).|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||months||Standard Deviation|Mean
71617|NCT01090011|Secondary|Objective Tumor Response (Complete Response [CR] and Partial Response [PR]) Determined by RECIST v1.1)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Objective tumor response = CR + PR."|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
71618|NCT01090011|Secondary|Disease Control (CR, PR and Stable Disease (SD) Determined by RECIST v1.1)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Disease control = CR + PR + SD.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients||95% Confidence Interval|Number
71619|NCT01090011|Secondary|Predose Plasma Concentrations of Afatinib for the Combination Arm|Predose plasma concentrations (Cpre,ss) of Afatinib at Course 1, Visit 2, 3, 4 and 5, at Course 2, Visit 1 and 2 and at Course 3, Visit 1.|Up to 57 days|Pharmacokinetic dataset (PKS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
71620|NCT01090011|Secondary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||L||Geometric Coefficient of Variation|Geometric Mean
71621|NCT01090011|Secondary|CL/F,ss,15|Apparent clearance of afatinib in plasma at steady state after extravascular multiple dose administration (CL/F,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||mL/min||Geometric Coefficient of Variation|Geometric Mean
71622|NCT01090011|Secondary|MRTpo,ss|mean residence time of Afatinib in the body at steady state after oral administration (MRTpo,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||h||Geometric Coefficient of Variation|Geometric Mean
71623|NCT01090011|Secondary|t1/2,ss|Terminal half-life of Afatinib in plasma at steady state (t1/2,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||h||Geometric Coefficient of Variation|Geometric Mean
71624|NCT01090011|Secondary|Peak-trough Fluctuation (PTF)|Peak-trough fluctuation (PTF) of plasma afatinib for the combination arm. PTF = 100*(Cmax-Cmin)/Caverage where Caverage = AUC/time, where time equals 24 hours.|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||% of average concentration||Geometric Coefficient of Variation|Geometric Mean
71625|NCT01090011|Secondary|Concentration of Afatinib in Plasma for the Combination Arm|Minimum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmin,ss). Maximum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmax,ss).|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
71626|NCT01090011|Secondary|Area Under the Concentration-time Curve (AUC) on Day 15 of Plasma Afatinib for the Combination Arm|Area Under the Concentration-time Curve (AUC) of Afatinib in plasma at steady state over a uniform dosing interval tau (15 days) (AUCtau,ss) after oral administration of Afatinib and cetuximab combination therapy|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
71627|NCT01090011|Secondary|Frequency (%) of Patients With Related Serious Adverse Events|Frequency (%) of patients with drug-related serious adverse events|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
71628|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Death||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
71629|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Treatment Discontinuation|Frequency (%) of patients with adverse events leading to treatment discontinuation|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
71631|NCT01090011|Secondary|Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
71632|NCT01090011|Secondary|Highest CTCAE Grade|Safety of afatinib when administered together with cetuximab as indicated by intensity and incidence of adverse events, graded according to the U.S. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version (v) 3.0|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.||percentage of patients|||Number
71633|NCT01090011|Primary|The Primary Endpoint is the Occurrence of Dose Limiting Toxicity (DLT).|"A DLT was defined as an AE or laboratory abnormality that a) related to the study regimen; b) or met any of the following criteria:~CTCAE Grade 2 or higher decrease in cardiac left ventricular function~CTCAE Grade 2 diarrhea lasting for 7 or more days, despite appropriate use of standard anti-diarrheal therapy~CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for at least 2 days~CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days~CTCAE Grade ≥3 rash despite standard medical management~CTCAE Grade ≥3 fatigue lasting for more than 7 days~CTCAE Grade 4 hypomagnesaemia or Grade 3 hypomagnesaemia with clinical significant sequelae~All other toxicities of CTCAE Grade ≥3 (except alopecia, and allergic reaction) leading to an interruption of afatinib and/or cetuximab for more than 14 days until recovery to baseline or Grade 1, whichever was higher."|from day 1 treatment until progression or undue toxicity, up to 28 days|Treated set for Cohort One. Cohort one was based on the data from the first treatment cycle where four patients received 'Afatinib 40+Cetuximab 250' and six patients received 'Afatinib 40+Cetuximab 500'.||participants|||Number
71634|NCT01089751|Secondary|Change From Baseline in Urgency Urinary Incontinence (UUI)|Urgency urinary incontinence is identified if the patient marks “Yes” for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||UUI episodes||Standard Deviation|Mean
71635|NCT01089751|Secondary|Change From Baseline in Urgency Severity|The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Score on a scale||Standard Deviation|Mean
71636|NCT01089751|Secondary|Change From Baseline in Voided Volume|Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||cubic centimeters (cc)||Standard Deviation|Mean
71637|NCT01089751|Secondary|Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)|The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores <= 30 indicate mild OAB, scores > 30 to 39 indicate moderate OAB, and scores >= 40 indicate severe OAB. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Score on a scale||Standard Deviation|Mean
71638|NCT01089751|Secondary|Change From Baseline in Urgency-Related Toilet Voids|Urgency-related toilet void (or urinary urgency) is identified if the patient marks “Yes” for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Toilet void||Standard Deviation|Mean
71639|NCT01089751|Secondary|Change From Baseline in Nocturic Toilet Voids|A nocturic (nighttime) toilet void is identified if the patient marks “Yes” for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Nocturic toilet void||Standard Deviation|Mean
71640|NCT01089751|Secondary|Change From Baseline in Continent Days Per Week (CDW)|Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Continent days per week||Standard Deviation|Mean
71641|NCT01089751|Primary|Percentage of Patients Continent (PPC)|PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.|Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.||Percentage of participants|||Number
71642|NCT01089608|Primary|Visual Analogue Scale (VAS - Ranges 0-100 mm)|The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)|Baseline and D63 (D63 minus baseline)|Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available.||units on a scale (from 0 to 100 mm)||95% Confidence Interval|Least Squares Mean
71643|NCT01089582|Secondary|Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12|The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.|Baseline to Week 12.|FAS.||participants|||Number
71644|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT||Week 12.|FAS.||participants|||Number
71645|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation|The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.|Baseline to Week 12.|FAS. Starting dose of ARICEPT was not summarized.||participants|||Number
71646|NCT01089582|Primary|Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.||scores on a scale||Standard Deviation|Mean
71647|NCT01089582|Primary|Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.||scores on a scale||Standard Deviation|Mean
71648|NCT01089582|Primary|Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12|The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question ‘compared to the severity of your relative’s condition at baseline, how much do you feel it has changed?’.|Baseline, Week 12.|FAS.||participants|||Number
71649|NCT01089582|Primary|Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12|CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.|Baseline, Week 12.|Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT.||participants|||Number
71650|NCT01089556|Secondary|Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint||Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).||participants|||Number
71651|NCT01089556|Other Pre-specified|Number of Participants Who Discontinued From Study Between Baseline and Week 8 Endpoint||Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).||participants|||Number
71652|NCT01089556|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint|TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).||participants|||Number
71653|NCT01089556|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (TEAE) Between Baseline and Week 8 Endpoint|TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0.|Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).||participants|||Number
71654|NCT01089556|Secondary|Mean Change in Heart Rate From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one heart rate measurement during Weeks 9- 16 (Study Period III). Last observation carried forward (LOCF) principle was used.||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
71656|NCT01089556|Secondary|Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BP measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
71657|NCT01089556|Other Pre-specified|Mean Change in Blood Pressure (BP) From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BP measurement during Week 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
71658|NCT01089556|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and at least one PGI-I measurement during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
71659|NCT01089556|Other Pre-specified|Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and at least one post-baseline PGI-I measurement during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
71660|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 9-16 (Study Period III).||hours||Standard Deviation|Mean
71661|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Baseline Through Week 8|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 1-8 (Study Period II).||hours||Standard Deviation|Mean
71662|NCT01089556|Secondary|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 9-16 (Study Period III).||days||Standard Deviation|Mean
71663|NCT01089556|Other Pre-specified|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 1-8 (Study Period II).||days||Standard Deviation|Mean
71664|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one HADS measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
71665|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline HADS measurements during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
71666|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one SDS measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||units on a scale||95% Confidence Interval|Least Squares Mean
72139|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 4|||mmol/g||Standard Deviation|Mean
71667|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline SDS measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||units on a scale||95% Confidence Interval|Least Squares Mean
71668|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one NPSI measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
71669|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline NPSI measurements during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
71670|NCT01089556|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and had at least one CGI-I measurement during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
71671|NCT01089556|Other Pre-specified|Clinical Global Impression of Improvement (CGI-I) at Week 8 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and had at least one post-baseline CGI-I measurement during Weeks 1-8 (Study Period II).||units on a scale||95% Confidence Interval|Least Squares Mean
71672|NCT01089556|Secondary|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
71673|NCT01089556|Other Pre-specified|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
71674|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
71675|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
92756|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)||Baseline up to Month 7|||percentage of participants|||Number
71676|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
71677|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.||percentage of participants|||Number
71678|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score|BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
71679|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II).||units on a scale||90% Confidence Interval|Least Squares Mean
71680|NCT01089556|Primary|Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).||units on a scale||95% Confidence Interval|Least Squares Mean
71681|NCT01089543|Secondary|Rate of Satisfactory Symptom Relief|"The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants."|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol.||Percentage of participants|||Number
71682|NCT01089543|Primary|Rate of Complete Dyspepsia Symptom Relief|The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) population defined as those participants who complied with the study protocol.||Percentage of Participants|||Number
71683|NCT01089517|Secondary|Proportion of Patients With at Least 1 Adverse Event||24 weeks|Safety Analysis Population||% of patients with adverse events|||Number
71684|NCT01089517|Secondary|The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit|The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit|24 weeks|Intent to Treat Population (last observation carried forward)||% of subjects gaining 15 or more letters|||Number
71685|NCT01089517|Primary|Mean Change in Visual Acuity From Baseline at the Week 24 Visit|The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit|24 Weeks|Intent to Treat Population (last observation carried forward)||ETDRS Letters||Standard Error|Mean
71686|NCT01089504|Secondary|Number of Participants With One or More Seizures|Any clinical or electrographic seizures occurring between study entry and all follow-up examinations and contacts.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.||participants|||Number
71687|NCT01089504|Secondary|Mean Bayley Scales of Infant Development (BSID) Score - Motor|This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
79527|NCT01005329|Secondary|Overall Survival|Will be estimated using the Kaplan-Meier method.|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
71688|NCT01089504|Primary|Mean Bayley Scales of Infant Development (BSID) Score - Cognitive|The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) – very similar to the more familiar IQ score.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.||units on a scale||Standard Deviation|Mean
71689|NCT01089413|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported.|Baseline up to Cycle 51 (1 cycle = 21 days)|FAS. Here, number of participants analyzed = participants with available data for this outcome and n = participants with available data for specified category, for each arm, respectively. No participants were evaluable for Cycles 48-50; hence, no data reported for these cycles.||percentage of participants|||Number
71690|NCT01089413|Secondary|Percentage of Participants With Best Overall Response|Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (<70 years, 70-80 years, and >80 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS. Here, number of participants analyzed = participants with available data for this outcome.||percentage of participants|||Number
71691|NCT01089413|Secondary|Progression-Free Survival (PFS)|PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and ≥70 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS.||months||95% Confidence Interval|Median
71692|NCT01089413|Primary|Duration of Bevacizumab Treatment|Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus [+] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and greater than or equal to [≥] 70 years) as well as for overall participants.|Baseline up to end of treatment (up to approximately 3 years)|FAS.||months||95% Confidence Interval|Median
71693|NCT01089231|Secondary|Blood Lipids|Fasting venous blood samples were collected and blood lipid levels were determined by an external contract laboratory (LADR, Hannover; Germany) at baseline (t0), after one week (t1) and after 12 weeks (t12) of supplementation.|baseline and after 12 weeks|||mg/dl||Standard Deviation|Mean
71694|NCT01089231|Secondary|Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)|Fasting venous blood samples were collected and RBC membrane FA composition including the omega-3 index, given as EPA + DHA, was analyzed at baseline and after 12 weeks according to the omega-3 index methodology (Harris & von Schacky, 2004). Results are presented as a percentage of the total identified FAs after response factor correction. The coefficient of variation for EPA + DHA was 5%. Quality was assured according to DIN ISO 15189.|baseline and after 12 weeks|||percentage of total fatty acids||Standard Deviation|Mean
71695|NCT01089231|Primary|Gene Expression Changes|Gene expression changes were measured by using whole genome microarrays. The expression values of all genes were compared between baseline and 4 hours, 7 days and twelve weeks after supplementation with FO or CO and differentially expressed genes were detected by standard two-state pooled-variance t-test (p<0,05). The number of differentially expressed genes (regulated genes)compared to the baseline values were determined for every study group in total as well as for every time point (4 hours, 7 days, 12 weeks)in total and specifically.|Gene expression changes (number of regulated genes)|||number of regulated genes|||Number
71696|NCT01089127|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
71709|NCT01089023|Secondary|Time to DAS28 Response by DAS28 Category|Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 <2.6), or Clinically Meaningful Improvement (change of >1.2 from baseline).|Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||days||Standard Error|Mean
71697|NCT01089127|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
71698|NCT01089062|Secondary|Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose|The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose|Patients with available data at the required time point were included in the analysis population.||milliseconds||Standard Deviation|Mean
71699|NCT01089062|Secondary|Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods|Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure.|baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose|Patients with available data at the required time point were included in the analysis population.||mmHg||Standard Deviation|Mean
71700|NCT01089062|Secondary|AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose|AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|4 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.||mmHg*min||Standard Deviation|Mean
71701|NCT01089062|Secondary|Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.||mmHg||Standard Deviation|Mean
71702|NCT01089062|Secondary|Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.||percentage of participants|||Number
71703|NCT01089062|Primary|AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose|AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|2 hours from time of first dose|Patients with available data at the required time point were included in the analysis population.||mmHg*min||Standard Deviation|Mean
71704|NCT01089023|Secondary|Erythrocyte Sedimentation Rate|ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||mm/hr||Standard Deviation|Mean
71705|NCT01089023|Secondary|C-Reactive Protein (CRP) Values by Study Visit|CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||mg/L||Standard Deviation|Mean
71706|NCT01089023|Secondary|HAQ-DI Score by Visit|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3..|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||scores on a scale||Standard Deviation|Mean
71707|NCT01089023|Secondary|Percentage of Participants With Improvement in Physical Function by HAQ-DI Category|Physical function scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI <1), moderate disability (1≤ HAQ-DI <2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
71708|NCT01089023|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
71777|NCT01087996|Secondary|Change in New York Heart Association Class at 12-months||12 months|||participants|||Number
71710|NCT01089023|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
71711|NCT01089023|Secondary|Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (>)5.1 indicated high disease activity, a score of >3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than <2.6 indicated disease remission. Week 24 is the Follow-Up visit.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n (number) at Week 24 equals (=) number of participants in that visit; n at Other Visits = number of participants with treatment administered"||percentage of participants|||Number
71712|NCT01089023|Primary|Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events|Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.|Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.||percentage of participants|||Number
71713|NCT01088997|Secondary|Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|An echocardiogram obtained while on milrinone was obtained with the goal of attempting to look for improvements in parameters associated with pulmonary hypertension. The primary parameter measured was the myocardial performance index (MPI). An Echocardiogram was performed at baseline (pre-infusion) and repeated 12-24 hours ater the initiation of the Milrinone infusion. Also known as the Tei index, the MPI is an index that incorporates both systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function. Systolic dysfunction prolongs preejection (isovolumic contraction time, IVCT) and a shortening of the ejection time (ET). Both systolic and diastolic dysfunction result in abnormality in myocardial relaxation which prolongs the relaxation period (isovolumic relaxation time, IVRT). Normal value for MPI is 0.39+/-0.05 with dilated cardiomyopathy value of MPI at 0.59+/-0.10 (both units on a scale)|Up to 24 hours after start of infusion|||units on a scale||Standard Deviation|Mean
71714|NCT01088997|Primary|Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min)|The schedule of milrinone pharmacokinetic (PK) sampling varied by weight to minimize blood sampling. For babies weighing less than 3kg, samples were drawn at the end of the bolus, 15 minutes prior to the end of infusion (EOI) and 20 minutes, 1, 2, 6 and 12 hours after EOI. For babies weighing 3kg or more, samples were drawn at the end of the bolus, 6 hours after start of infusion, 15 minutes prior to the EOI and 30 minutes, 1, 3, 9 and 15 hours after EOI. Milrinone plasma concentrations were determined using a validated high-performance mass spectrometry assay.|End of bolus dose, 15 minutes prior to end of infusion (EOI), at four time points after EOI with final sample at 12-15 hours after EOI (timing based on infant's weight)|The pharmacokinetic analysis, including the primary outcome parameter, Clearance, was planned a priori to include all the participants pooled together. A PK analysis by arm wouldn't be appropriate. The randomization arms were only created to explore the secondary clinical and pharmacodynamic outcomes.||mL/min/3.4 kg||Standard Error|Mean
71715|NCT01088997|Secondary|Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|Oxygenation Index (mean airway pressure*Fraction of Inspired Oxygen/Partial Pressure of Oxygen in the blood) was calculated at baseline and every 6 hours after start of infusion until 12-24 hours after initiation of milrinone infusion.|for up to 24 hours after start of infusion|OI was calculated every 6 hours after start of infusion for 24 hours.||units on a scale||Standard Deviation|Mean
71716|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until 24 Hours After Study Drug Administration (AUC0-24) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
71717|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until the Last Measurable Plasma Concentration (AUC0-t) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
71718|NCT01088984|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||hours||Geometric Coefficient of Variation|Geometric Mean
79528|NCT01005329|Secondary|Percentage of Participants With Treatment-related Adverse Events as Assessed by NCI CTCAE v4.0||From start of treatment to end of follow-up||||||
71719|NCT01088984|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
71720|NCT01088984|Secondary|Duration of Response (DOR)|DOR was determined for the participants with CR or CRp in the primary analysis set, defined as the time from first achieving remission to the time when progression was diagnosed, the participant died, or the participant started receiving new antineoplastic therapy. Data from participants who do not progress were censored at the last valid assessments. Median DOR and its 95% confidence interval was determined based on the Kaplan-Meier method. Data from participants who received a transplant were censored at the time of the transplant.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|No duration of remission (defined as CR or CRp) analysis was performed for participants in the primary analysis since none achieved remission.|||||
71721|NCT01088984|Secondary|Best Overall Tumor Response Rate, by Phase|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The safety analysis set included all participants treated at any dose of bendamustine.||percentage of participants||95% Confidence Interval|Number
71722|NCT01088984|Secondary|Best Overall Tumor Response Rate|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.||percentage of participants||95% Confidence Interval|Number
71723|NCT01088984|Primary|Overall Response Rate (ORR)|ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (CR), divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10^9/L and absolute neutrophil count ≥ 1.0 × 10^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.|Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.||percentage of participants||95% Confidence Interval|Number
71724|NCT01088984|Primary|Recommended Phase II Dose (RP2D) of Bendamustine|RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m^2 were explored, and escalation to 150 mg/m^2 would only occur if the 120 mg/m^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m^2 dose; de-escalation to the 60 mg/m^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.|Induction Cycle (21- to 35-day cycle)|All participants enrolled in Phase 1 of the study.||mg/m^2|||Number
71725|NCT01088711|Secondary|Plasma Glucose Concentration|Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.||mg/dL||95% Confidence Interval|Least Squares Mean
71726|NCT01088711|Secondary|WAA Total GLP-1 Concentration|WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.||pmol/L||95% Confidence Interval|Least Squares Mean
71792|NCT01087957|Secondary|Berg Balance Scale|The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|6 months|||units on a scale||Standard Error|Mean
71727|NCT01088711|Secondary|WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration|Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.||pmol/L||95% Confidence Interval|Least Squares Mean
71728|NCT01088711|Secondary|Percent Inhibition of DPP-4 After Day 22|Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post dose on Day 22|No data from obese healthy participants (Panel A) were collected after pre-dose on Day 22. Therefore, data are presented only for obese T2D participants (Panel B) 168 hours post-dose on Day 22.||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
71729|NCT01088711|Secondary|Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15|Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post-dose on Day 15|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 168 hours post-dose on Day 15 were pooled according to treatment. Predose data from Day 1 were missing from 2 participants.||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
71730|NCT01088711|Primary|Number of Participants Withdrawing From Study Therapy Due to an AE||Up to Day 22|AEs were monitored in all obese healthy (Panel A) and T2D (Panel B) participants who received omarigliptin 50 mg or placebo.||Participants|||Number
71731|NCT01088711|Primary|Number of Participants Experiencing an Adverse Event (AE)||Up to Day 36|AEs were monitored in all obese healthy (Panel A) and Type 2 diabetes (T2D) (Panel B) participants who received omarigliptin 50 mg or placebo.||Participants|||Number
71732|NCT01088672|Secondary|Mortality at 90 Days|All cause mortality through 90 days post procedure.|90-day|||participants|||Number
71733|NCT01088672|Secondary|Clinical Outcomes at 90 Days|"Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.~mRS 0-2 indicates functional independence 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~https://en.wikipedia.org/wiki/Modified_Rankin_Scale"|90-day|||percentage of subjects with mrs 0-2|||Number
71734|NCT01088672|Primary|Revascularization Status|"Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure~Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.~Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...~Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment|||percentage of subjects TICI 2 or >|||Number
71735|NCT01088646|Primary|Percentage of Capsule Placement Success Using PillCam® Express Capsule Endoscopy Delivery System||up to 7 days||||||
71736|NCT01088646|Primary|Number of Participants With Successful Capsule Placment Into the Duodenum Using Capsule Delivery System|The number of capsules that successfully were in the duodenum as indicated by video images|up to 7 days|||participants|||Number
71737|NCT01088529|Secondary|Number of Participants With Prostate-Specific Antigen Response|The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.|Cycle 3 Day 1|"Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||participants|||Number
71738|NCT01088529|Secondary|Number of Participants With a Positive Surgical Margin at Radical Prostatectomy|The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.||participants|||Number
71739|NCT01088529|Primary|Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)|The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.||participants|||Number
71740|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index|The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.|Day 0 (study enrollment)|All enrolled participants who had Duke CAD Index completed.||units on a scale||Standard Deviation|Mean
71741|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin||Day 0 (study enrollment)|All enrolled participants who had pre-procedure hemoglobin evaluation.||grams/deciliter (g/dL)||Standard Deviation|Mean
71742|NCT01088503|Secondary|Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness||15 months|Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted.|||||
71743|NCT01088503|Secondary|Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events|Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.|Baseline through 15 months|Participants who were treated with prasugrel or clopidogrel.||percentage of participants||95% Confidence Interval|Number
71744|NCT01088503|Secondary|Percentage of Participants With MACE Over 1, 6 and 15 Months|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.|Baseline through 1, 6 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.||percentage of participants||95% Confidence Interval|Number
71745|NCT01088503|Secondary|Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.||percentage of participants||95% Confidence Interval|Number
71746|NCT01088503|Secondary|Percentage of Participants With Cumulative Severe or Moderate Bleeding Events|Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) * 100.|Baseline, 1, 6, 12 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment.||percentage of participants||95% Confidence Interval|Number
71747|NCT01088503|Primary|Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment|Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. <1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.|Day 0 (study enrollment)|All enrolled participants||participants|||Number
71748|NCT01088503|Primary|Percentage of Participants With Major Adverse Cardiovascular Events (MACE)|MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.||percentage of participants||95% Confidence Interval|Number
71749|NCT01088464|Primary|PK: Vss of Necitumumab After Multiple Doses|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Data did not allow calculation of Vss for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Vss values for Day 29 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.||mL||Geometric Coefficient of Variation|Geometric Mean
71750|NCT01088464|Primary|PK: Steady-State Volume of Distribution (Vss) of Necitumumab After Single Dose|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Vss was not analyzed for participants in Cohorts 1 and 3 as Vss is derived from AUC (0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Vss values for Day 1 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
79529|NCT01005329|Secondary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events as Assessed by NCI CTCAE v4.0||From start of treatment to one year||||||
71751|NCT01088464|Primary|PK: CL of Necitumumab After Multiple Doses|CL is defined as the volume of plasma that is cleared of study drug per unit time. Data did not allow calculation of CL for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had CL values for Day 29 of Cycle 1. CL of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.||mL/h||Geometric Coefficient of Variation|Geometric Mean
71752|NCT01088464|Primary|PK: Clearance (CL) of Necitumumab After a Single Dose|CL is defined as the volume of plasma that is cleared of study drug per unit time. CL was not analyzed for participants in Cohorts 1 and 3 as CL is derived from AUC(0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received single dose of study drug and had CL values for Day 1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for CL on Day 1 of Cycle 1, due to fraction of data outside tlast >30%||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
71753|NCT01088464|Primary|PK: t½ of Necitumumab After Multiple Doses|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had t½ values for Day 29 of Cycle 1.||h||Geometric Coefficient of Variation|Geometric Mean
71754|NCT01088464|Primary|PK: Half-Life (t½) of Necitumumab After a Single Dose|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had t½ values for Day 1 of Cycle 1.||h||Geometric Coefficient of Variation|Geometric Mean
71755|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to 336 h Postdose [AUC(0-336)] of Necitumumab After Multiple Doses|Steady state AUC(0-336) values are reported.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had AUC(0-336) values for Day 29 of Cycle 1.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
71756|NCT01088464|Secondary|Immunogenicity (IK): Number of Participants With Treatment-Emergent Anti-IMC-11F8 Antibodies|Treatment-emergent samples were defined as samples which showed at least 4-fold difference (2 dilution increase) at post-baseline in IK titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|For Cohorts 1, 2 and 3: Prior to first infusions of Cycles 1, 2, and 4 and at the 30-day follow-up visit (+7 days) after the last dose of study drug|All participants who received any quantity of study drug.||participants|||Number
71757|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of Necitumumab After a Single Dose|AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for all the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|"All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day~1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for AUC(0-∞) on Day 1 of Cycle 1, due to fraction of data outside tlast >30%"||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
71758|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Last Time Point [AUC (0-tlast)] of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day 1 of Cycle 1.||micrograms*hour/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
71759|NCT01088464|Primary|PK: Cmin of Necitumumab After Multiple Doses|Cmin was calculated prior to the last dose of the initial 6-week treatment cycle.|Cycle 1; Cohorts 1and 3: prior to fourth infusion. Cohort 2: prior to third infusion|All participants who received multiple doses of study drug and had Cmin serum concentrations prior to last dose of Cycle 1.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
71760|NCT01088464|Primary|PK: Minimum Concentration (Cmin) of Necitumumab After a Single Dose|Cmin is defined as the minimum concentration the drug achieved after administration of first infusion and prior to the administration of second infusion.|Cycle 1; Cohorts 1, 2 and 3: prior to second infusion|All participants who received single dose of study drug and had Cmin serum concentrations analyzed prior to administration of second dose.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
71761|NCT01088464|Primary|PK: Cmax of Necitumumab After Multiple Doses|Cmax at steady state (after the last dose of the initial 6-week treatment cycle).|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Cmax values for Day 29 of Cycle 1.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
71762|NCT01088464|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 hours (h) after end of infusion. Cohort 2: predose, immediately after infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Cmax values for Day 1 of Cycle 1.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
71763|NCT01088464|Primary|Number of Participants With 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Data presented are the number of participants who experienced 1 or more TEAEs or SAEs regardless of causality. An adverse event was considered as TEAE if it occurred any time after the administration of the first dose of study drug or up to 30 days after the last dose of study treatment or if it occurred prior to the first dose and worsened while on treatment. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.|Baseline up to 24 weeks plus 30 days post last dose of study drug|All participants who received any quantity of study drug.||participants|||Number
71764|NCT01088438|Primary|Probing for Biomedical Issues|Probability that the learner probes biomedical red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a biomedical red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT||proportion of encounters|Participants|95% Confidence Interval|Number
71765|NCT01088438|Primary|Probing for Contextual Issues|Probability that the learner probes contextual red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a contextual red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT||proportion of encounters|Participants|95% Confidence Interval|Number
71766|NCT01088438|Primary|Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters)|Probability that the learner writes a correct treatment plan for the standardized patient encounters undertaken at assessment at end of subinternship that include contextual red flags. All learners are scheduled to see 4 encounters, based on combinations of four cases and four potential variants (baseline, biomedical, contextual, biocontextual) with counterbalancing by study month; each has a single contextual variant encounter. Treatment plans are assessed by an investigator blinded to the learner's assignment to intervention or control group.|1 month|ITT. In one case, a participant did not receive a contextual variant encounter because the standardized patient was ill, and this encounter is excluded.||proportion of contextual encounters|Participants|95% Confidence Interval|Number
71767|NCT01088399|Other Pre-specified|Number of Participants Who Died While in the Study||Study enrollment up to approximately 10 years|All participants with baseline and at least 1 post-baseline visit.||participants|||Number
71768|NCT01088399|Secondary|Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).|QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction).|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and has a Total Z Score.||Z-score||Standard Deviation|Mean
71769|NCT01088399|Secondary|Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)||Baseline through 10 years|All participants with baseline and at least 1 post-baseline visit and who provided bone fracture information.||percentage of participants|||Number
71770|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Waist Circumference|Change in waist circumference was used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had waste circumference data.||centimeters (cm)||Standard Deviation|Mean
71771|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides|Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had cholesterol or triglyceride data.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
71772|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)|Change in SBP and DBP were used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and BP data.||millimeters of mercury (mmHg)||Standard Deviation|Mean
71773|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)|Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had BMI data.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
71774|NCT01088399|Primary|Clinically Significant Adverse Events|A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.|Baseline to study completion (approximately 10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated).||percentage of participants|||Number
71775|NCT01088295|Secondary|Safety and Tolerability of Telmisartan||24 weeks||||||
71776|NCT01088295|Primary|Median Change in Visceral Adipose Tissue (VAT) Volume|VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography|Baseline and 24 weeks|as-treated analysis||cm^2||Inter-Quartile Range|Median
71778|NCT01087996|Secondary|Change in Minnesota Living With Heart Failure Total Score|The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months|||units on a scale||95% Confidence Interval|Mean
71779|NCT01087996|Secondary|Change in Distance Walked in 6-minutes From Baseline.||12-months|||meters||95% Confidence Interval|Mean
71780|NCT01087996|Secondary|CT Measure of Scar Size as % of LV Mass||Baseline Month 13 post-catheterization|||percent||95% Confidence Interval|Mean
71781|NCT01087996|Secondary|CT Measure of End Systolic Volume||Baseline Month 13 post-catheterization|||ml||95% Confidence Interval|Mean
71782|NCT01087996|Secondary|CT Measure of End Diastolic Volume||Baseline Month 13 post-catheterization|||ml||95% Confidence Interval|Mean
71783|NCT01087996|Secondary|CT Measure of Left Ventricular Ejection Fraction||Baseline Month 13 post-catheterization|||percent||95% Confidence Interval|Mean
71784|NCT01087996|Secondary|CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month|Percentage change from 13-months post-catheterization to baseline.|Baseline Month 13 post-catheterization|||percent change from baseline||95% Confidence Interval|Mean
71785|NCT01087996|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||One month post-catheterization|||percentage of participants||95% Confidence Interval|Number
71786|NCT01087970|Other Pre-specified|Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)|Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.|From enrollment to 30 days post-treatment discontinuation up to 26.4 months|All enrolled participants who received at least 1 dose of any study drug.||participants|||Number
71787|NCT01087970|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant’s speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant’s response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.||units on a scale||Standard Deviation|Mean
71788|NCT01087970|Secondary|Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant’s rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.||units on a scale||Standard Deviation|Mean
71789|NCT01087970|Secondary|Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)|PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)|All treated participants excluding those from a noncompliant study site.||percentage of participants||95% Confidence Interval|Number
71790|NCT01087970|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.|From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.||months||95% Confidence Interval|Median
71791|NCT01087970|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.||months||95% Confidence Interval|Median
71793|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Stair Time|The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .|6 months|||seconds||Standard Error|Mean
71794|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Obstacle Course|The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.|6 months|||seconds||Standard Error|Mean
71795|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Timed up and Go|The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.|6 months|||seconds||Standard Error|Mean
71796|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Carpet Time|The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .|6 months|||seconds||Standard Error|Mean
71797|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Floor Time|The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.|6 months|||seconds||Standard Error|Mean
71798|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Total Score|The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up & Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.|6 months|||seconds||Standard Error|Mean
71799|NCT01087957|Secondary|Six Minute Walk Test||6 months|||meters||Standard Error|Mean
71800|NCT01087957|Primary|Device Related Serious Adverse Events|The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).|6 months|Intention to treat||number of device related SAEs|||Number
71801|NCT01087957|Primary|Stroke Impact Scale (SIS) Composite Score|The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.|6 months|Intention to treat||points||Standard Error|Mean
71802|NCT01087957|Primary|Gait Velocity|Improved ambulation status, specific to increase in gait velocity (m/s)|6 months|Intention to treat||m/sec||Standard Error|Mean
71803|NCT01087944|Secondary|Number of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Upto Day 36|The ITT population included all participants who received at least one injection||participants|||Number
71804|NCT01087944|Secondary|Number of Participants With Abnormalities in Electrocardiograms|A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71805|NCT01087944|Secondary|Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure|The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine.|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71806|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Creatinine|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter [umol/L]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71816|NCT01087918|Primary|10 Meter Walking at Maximal Speed|The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||meters per second||Standard Deviation|Mean
71817|NCT01087918|Secondary|Falls Efficacy Scale|The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
71807|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71808|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre [U/L]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71809|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71810|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71811|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10*9/L), for WBC was 3.0-18.0 (10*9/L), for Basophils was 0.00-0.40 (10*9/L), for Eosinophil was 0.00-0.90 (10*9/L), for Lymphocytes was 0.70-7.60 (10*9/L), Monocyte was 0.00-1.70 (10*9/L), and Neutrophil 1.50-9.25 (10*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71812|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematocrit|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71813|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter [g/L]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection||participants|||Number
71814|NCT01087944|Primary|Feasibility of Peginterferon Alfa-2a Administration by Autoinjector|The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a “Yes” or “No” response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The intent-to-treat (ITT) population included all participants who received at least one injection||participants|||Number
71815|NCT01087918|Secondary|Figure of Eight Test|The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||meters per second||Standard Deviation|Mean
72140|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)|||mmol/24h||Standard Deviation|Mean
71818|NCT01087918|Secondary|Response Time of the Lower Extremities|We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|||milliseconds||Standard Deviation|Mean
71819|NCT01087918|Secondary|Pain on a Visual Analogue Scale|Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.||units on a scale||Standard Deviation|Mean
71820|NCT01087918|Secondary|Manual Muscle Test of the Lower Extremity|With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
71821|NCT01087918|Secondary|Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis|Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|||milliseconds||Standard Deviation|Mean
71822|NCT01087918|Secondary|Spinal Cord Independence Measure III|The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
71823|NCT01087918|Secondary|Berg Balance Scale|The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
71824|NCT01087918|Secondary|Walking Index for Spinal Cord Injury II|The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||units on a scale||Standard Deviation|Mean
71825|NCT01087918|Primary|10 Meter Walking at Preferred Speed|The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)|||meters per second||Standard Deviation|Mean
71826|NCT01087905|Secondary|Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group|For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.|26 weeks after the target quit smoking date|"No a priori power analysis was conducted for this secondary outcome."||U.S. Dollars|||Number
71827|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.||Percentage of participants not smoking|||Number
71828|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Intervention|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.||Percentage of participants not smoking|||Number
71829|NCT01087814|Primary|Serum Levels of Efavirenz|Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.|5th day of taking drug|||ng/mL||Standard Deviation|Mean
71830|NCT01087801|Primary|Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).|Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.|First 5 minutes after treatment administration|||Participants|||Number
71831|NCT01087801|Primary|Endoscopic Sample|"Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8).~(Note- The outcome value is boolean (yes or no) as an answer)."|First 5 minutes after treatment administration||||||
71897|NCT01086761|Primary|Maximal Tolerated Dose (MTD) Following a Single Injection|MTD was defined as one dose level below the lower of the dose level in which a severe (sight-threatening) drug-related Adverse Event occurred or the dose level at which more than 2 patients experienced a moderate ocular (eye) drug-related toxicity.|16 weeks|All treated participants.||mg|||Number
71832|NCT01087788|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48|"Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome).~For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6."|From Baseline to Week 48|Randomized Set (RS) with imputation: for subjects who withdrew for any reason, or subjects with missing Week 48 measurements, and for all placebo subjects after the switch to CZP, Week 48 scores are linearly extrapolated from the last two available radiographs prior to early withdrawal or Week 24 or before receiving CZP.||units on a scale||95% Confidence Interval|Least Squares Mean
71833|NCT01087788|Secondary|Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline|The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
71834|NCT01087788|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
71835|NCT01087788|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 24|ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
71836|NCT01087788|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with imputation: for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, scores are linearly extrapolated from the last two radiographs prior to early withdrawal or Week 24 or before receiving CZP.||units on a scale||95% Confidence Interval|Least Squares Mean
71837|NCT01087788|Primary|American College of Rheumatology 20 (ACR20) Response at Week 12|ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
71854|NCT01087723|Secondary|The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71838|NCT01087762|Secondary|Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12|The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 140 are included in this analysis.||units on a scale||Standard Deviation|Mean
71839|NCT01087762|Secondary|Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12|The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 148 are included in this analysis.||units on a scale||Standard Deviation|Mean
71840|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24|The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
71841|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12|The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.||units on a scale||95% Confidence Interval|Least Squares Mean
71842|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
71843|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.||units on a scale||95% Confidence Interval|Least Squares Mean
71855|NCT01087723|Secondary|The Incidence of Death at 1 Year|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time.|Within 1 Year|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71954|NCT01085734|Secondary|Number of Injections Needed|number of Avastin and Ozurdex injections needed|baseline to 6 months|||injections|||Number
71844|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.||units on a scale||95% Confidence Interval|Least Squares Mean
71845|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12|The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.||units on a scale||95% Confidence Interval|Least Squares Mean
71846|NCT01087762|Secondary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:~Patient's Global Assessment of Disease Activity~Pain assessment (total spinal pain)~Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))~Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)~and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
71847|NCT01087762|Primary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:~Patient's Global Assessment of Disease Activity~Pain assessment (total spinal pain)~Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))~Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)~and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.||percentage of participants||95% Confidence Interval|Number
71848|NCT01087736|Other Pre-specified|PTSD Symptom Severity|The average PTSD symptom severity score during treatment (weeks 4, 8, 12). The PTSD Checklist (PCL) is a self-report measure of the 17 DSM-IV symptoms of PTSD. Respondents rate on a scale from 1 (not at all) to 5 (extremely) how much they were bothered by each symptom in the past month. A total symptom severity score (range = 17 - 85) can be obtained by summing the scores from the 17 items, with higher scores indicating greater severity of PTSD symptoms. Mean scores may be calculated for subscales of intrusion (range 5-25), avoidance (range 7-35), and arousal (range 5-25).|Weeks 4, 8, 12|||units on a scale||Standard Deviation|Mean
71849|NCT01087736|Primary|Percent Drinking Days (%DD)|"Alcohol consumption was assessed at baseline and weekly during the treatment phase (12 weeks) using the Time Line Follow Back (TLFB) interview which yields number of days of alcohol use (DD).~DD: day on which alcohol was consumed Standard alcoholic drink defined as containing 13.6 g of pure alcohol."|Weekly, weeks 1-12, average|||percent days in a week||Standard Deviation|Mean
71850|NCT01087723|Secondary|The Incidence of Stroke|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71851|NCT01087723|Secondary|The Incidence of Thrombocytopenia|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71852|NCT01087723|Secondary|The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71853|NCT01087723|Secondary|The Incidence of Minor Bleeding: TIMI and GUSTO|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71856|NCT01087723|Secondary|The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)|Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71857|NCT01087723|Secondary|The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding|A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71858|NCT01087723|Primary|The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding|A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion.|Within 30 days|Participants who were randomized and signed an ICF; ITT population||percentage of participants|||Number
71859|NCT01087541|Secondary|Systolic and Diastolic Blood Pressure||6 months|||mmHg||Standard Deviation|Mean
71860|NCT01087541|Secondary|Blood Pressure ( Systolic / Diastolic )||Baseline|||mmHg||Standard Deviation|Mean
71861|NCT01087541|Primary|Glycosylated Haemoglobin A1c at 6 Months|Glycohemoglobin A1c at 6 months.|6 months|||Percentage||Standard Deviation|Mean
71862|NCT01087541|Secondary|BMI at 6 Months||6 months|||kg/m2||Standard Deviation|Mean
71863|NCT01087541|Secondary|BMI ( Body Mass Index ) at Start||Baseline|||kg/m2||Standard Deviation|Mean
71864|NCT01087541|Primary|Glycosylated Haemoglobin A1c at Start||Baseline|||Percentage||Standard Deviation|Mean
71865|NCT01087528|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:~poor cleansing level (Large amount of fecal residue.)~fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)~good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)~excellent cleansing level (No more than small bits of adherent feces.)"|within 7 days||||||
71866|NCT01087528|Primary|Specificity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|within 7 days||||||
71867|NCT01087528|Primary|Sensitivity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category .The false negative rate is equal to 1 - sensitivity and indicated the percentage of polyps missed by capsule endoscopy.|within 7 days|||percentage of participants||95% Confidence Interval|Number
71868|NCT01087502|Secondary|Plasma Concentration of Linagliptin at Trough|Trough levels of concentration of Linagliptin in plasma.|Week 12, 24 and 52|FAS original results (OR). Original results analysis means that data is analyzed exactly as observed, values after rescue medication are not set to missing and no imputation rule is applied for replacing the missing values.||Nmol/L||Geometric Coefficient of Variation|Geometric Mean
71869|NCT01087502|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%|The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline, week 12 and week 52|FAS with non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.||percentage of patients|||Number
71870|NCT01087502|Secondary|Percentage of Patients With HbA1c <6.5%|The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=6.5% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.||percentage of patients|||Number
71884|NCT01086852|Secondary|Dose Per Infusion (IU/kg)|weight adjusted dose per infusion until a subject was no longer at risk of bleeding due to surgery|before surgery, during the post operative period|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||IU/kg||Full Range|Median
71871|NCT01087502|Secondary|Percentage of Patients With HbA1c <7.0%|The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.||percentage of patients|||Number
71872|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline Over Time|This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.||mg/dL||Standard Deviation|Mean
71873|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|One patient in the Placebo/Glimepiride arm and one patient in the Linagliptin arm without FPG on-treatment value. Results do not contain data of patients from the excluded study site.||mg/dL||Standard Error|Mean
71874|NCT01087502|Secondary|HbA1c Change From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.||Percent||Standard Deviation|Mean
71875|NCT01087502|Primary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.|Baseline and week 12|"FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.~Results for primary endpoint below are the ones reproduced without patients from the excluded study site."||Percent||Standard Error|Mean
71876|NCT01087489|Secondary|Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage|"Presence of corneal staining after the injection:~Quadrants of fluorescein staining: 0 1 2 3 4~Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion~Size of subconjunctival hemorrhage:~in clock hours"|within 10 minutes of the injection|all eyes for which data were available were included||units on a scale|Participants|Standard Deviation|Mean
71877|NCT01087489|Secondary|Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg|intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection.|immediately after injection, at 5, 10, 15 minutes|48 participants were included in each arm, i.e. each participant received both methods, one eye twice if unilateral or both eyes if bilateral disease were randomily assigned to alternate prep on consecutive or same visit respectively||mmHg|Participants|Standard Deviation|Mean
71878|NCT01087489|Primary|Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection|"Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe~Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied"|immediately after injection, 1- hour later, and next day|all 50 patients who completed the study were included in the analysis, each patient received both anesthetic preparations prior to two consecutive (if unilateral disease) intravitreal injections on consecutive visits or in fellow eyes (if bilaterla disease) on the same day||units on a scale||Standard Deviation|Mean
71879|NCT01086969|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination|Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia|Day 0 to 7 post-vaccination|Safety parameters were assessed in the safety analysis set||Participants|||Number
71880|NCT01086969|Primary|Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 to 30 post-vaccination|Four-fold antibody increase were determined in the immunogenicity analysis set||Percentage of Participants|||Number
71881|NCT01086969|Primary|Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 and Day 30 post-vaccination|Geometric mean titers were determined in the immunogenicity analysis set||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
71882|NCT01086969|Primary|Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination|Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.|Baseline and 21 days post-vaccination|Menactra vaccine antibody titers were determined in the immunogenicity analysis set.||Participants|||Number
71883|NCT01086852|Primary|Number of Participants With Degree of Bleeding Control Rated as Excellent.|"Investigators made an overall assessment of FACTOR X in controlling bleeding at the End of Treatment Assessment. The degree of bleeding control was rated as excellent, good, poor or unassessable, in accordance with the following criteria listed below:~Excellent -Parameters were similar to those in subjects without a bleeding disorder.~Good -Parameters were inferior to those in subjects without a bleeding disorder, but no other factor X containing agents were required to restore haemostasis.~Poor - Blood loss was excessive (defined as more than twice the pre defined amount that would be expected in a subject without a bleeding disorder for this type of surgery) and/or Haemostasis was not achieved and/or Additional factor X containing agents were required to restore haemostasis.~Unassessable -Efficacy was not possible to assess, or Additional factor X containing agents (excluding blood transfusions) were required before efficacy of FACTOR X could be assessed."|During and till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||Participants|||Number
71885|NCT01086852|Primary|Change of Haemoglobin From Pre-surgery Till End of Treatment|The subject’s haemoglobin was measured pre operatively, within 2 hours post operatively and at the End of Treatment Assessment. Changes in the subject’s haemoglobin from pre to post operatively and from post operatively to the End of Treatment Assessment were assessed, taking into account the volume of fluid infused into the subject during the intervening periods, any blood transfusions in the intervening periods, the subject’s haematocrit at the same time points and the subject’s pre dose serum ferritin|2 hrs pre-operatively till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||g/L||Standard Deviation|Geometric Mean
71886|NCT01086852|Primary|Number of Post Operative Bleeding Episodes (See Table Below)|Bleeding was assessed at least once each day by the investigator, more frequently if indicated by the severity of the operation or the subject’s response. This included all bleeding episodes from the end of the surgical procedure until the subject was no longer at risk of bleeding due to surgery|End of surgery till end of study|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||number of bleeds|||Number
71887|NCT01086852|Primary|Requirement for Blood Transfusion|Number of blood transfusions required (units of packed red blood cells or units of whole blood) or infusion of autologous red cells during and after surgery|during and after surgery|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||number of transfusions|||Number
71888|NCT01086852|Primary|Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder.|The investigator's estimation of the volume of blood loss during surgery compared to the volume of blood loss expected in patients without a bleeding disorder undergoing the same surgical procedure and reported as greater than, equal to or less than.|After wound closure|All subjects treated with FACTOR X||participants|||Number
71889|NCT01086852|Secondary|Incremental Recovery After Bolus Dose of FACTOR X|"Incremental Recovery of FX:C after the Pre surgery Bolus Infusion The factor X increment is calculated by subtracting the pre-infusion factor X level from the post-dose value.~Incremental recovery is calculated by FX increment (IU/dL)/ FX dose (IU/kg)"|incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||IU/dL per IU/kg||Standard Deviation|Geometric Mean
71890|NCT01086852|Primary|Clinical Estimation of Volume of Blood Loss During Surgery|"As soon as possible after wound closure, the investigator estimated the volume of blood loss during surgery and made a clinical assessment against the volume of blood loss typically expected in a normal patient (i.e. one without a bleeding disorder and undergoing the same surgical procedure). The assessment may have been supported by a swab and pad count.~The clinical assessment was rated as follows:~Blood loss less than expected~Blood loss as expected~Blood loss more than expected~Blood loss excessive (defined as more than twice the pre defined amount that would be expected in a normal patient for this type of surgery)"|Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X.|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.||ml||Standard Deviation|Geometric Mean
71891|NCT01086761|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|Safety Population included all treated participants.||Participants|||Number
71892|NCT01086761|Secondary|Maximum Serum Concentration (Cmax) of MP0112 at Day 3|Blood samples were collected for MP0112 levels on Day 3. The serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory and were analyzed for MP0112 levels using an enzyme-linked immunosorbent assay. Maximum concentration at Day 3 was calculated.|Day 3|Pharmacokinetic (PK) Population included all treated participants with PK data.||Nanomolar (nM)|||Number
71893|NCT01086761|Secondary|Area of Lesion as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye after fluorescein application at Baseline and Week 4. A lower number indicated a smaller lesion area.|Baseline, Week 4|All treated participants with data available for analysis.||mm^2||Standard Deviation|Mean
71894|NCT01086761|Secondary|Area of Leakage as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye 10 minutes after fluorescein application at Baseline and Week 4. A lower number indicated a smaller area of leakage.|Baseline, Week 4|All treated participants.||mm^2||Standard Deviation|Mean
71895|NCT01086761|Secondary|Change From Baseline in Central Area Retinal Thickness|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Week 4. A negative change from Baseline indicated improvement (less retinal thickness). A positive change from Baseline indicated worsening (definite retinal thickening).|Baseline, Week 4|All treated participants.||μm||Standard Deviation|Mean
71896|NCT01086761|Secondary|Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 4. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision. Stable or Improved BCVA was defined as a loss of <15 letters read correctly compared to Baseline.|Baseline, Week 4|All treated participants.||Percentage of participants|||Number
71955|NCT01085734|Primary|Change From Baseline Visual Acuity at 6 Months|Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|6 months|||ETDRS score||Standard Deviation|Mean
71898|NCT01086475|Primary|Social Responsiveness Scale (SRS) at Follow-Up|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:~0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Week 22|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.||units on a scale||Standard Deviation|Mean
71899|NCT01086475|Secondary|Clinical Global Impressions Improvement Scale Responder Analysis|The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point. The CGI-I was completed at each visit, but only at week 11 were those subjects classified as “much” or “very much improved” defined as responders and all other classifications will be regarded as non-responders.|Week 11|Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.||percentage of participants|||Number
71900|NCT01086475|Primary|Social Responsiveness Scale (SRS) Change|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:~0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Baseline and Week 11|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.||units on a scale||Standard Deviation|Mean
71901|NCT01086410|Secondary|Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline|Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Beats per minute||Standard Deviation|Mean
71902|NCT01086410|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline|SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
71903|NCT01086410|Secondary|Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
71904|NCT01086410|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
71905|NCT01086410|Secondary|Change From Baseline in Albumin and Total Protein Values at Day 42/EW|Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter||Standard Deviation|Mean
71906|NCT01086410|Secondary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW|Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
71956|NCT01085682|Primary|Incidence of Type 2 Diabetes Mellitus|Incidence of type 2 diabetes mellitus|one year follow up|||participants|||Number
72141|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8|||mmol/24h||Standard Deviation|Mean
71907|NCT01086410|Secondary|Change From Baseline in Hematocrit Values at Day 42/EW|Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1||Standard Deviation|Mean
71908|NCT01086410|Secondary|Change From Baseline in Hemoglobin Values at Day 42/EW|Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
71909|NCT01086410|Secondary|Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW|Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
71910|NCT01086410|Secondary|Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/Early Withdrawal (EW)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage||Standard Deviation|Mean
71911|NCT01086410|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Day 42 (Visit 5)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug.||Participants|||Number
71912|NCT01086410|Secondary|Tmax and Tlast of VI at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||hours||Full Range|Median
71913|NCT01086410|Secondary|Cmax for VI on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
71914|NCT01086410|Secondary|AUC(0-t) for VI on Day 42|Area under the concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||picograms*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
71915|NCT01086410|Secondary|Tmax and Tlast of FF at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||hours||Full Range|Median
71916|NCT01086410|Secondary|Cmax for FF on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
72045|NCT01084551|Secondary|Patient Global Impression (PGI) Improvement|"PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||Percentage of Participants|||Number
71917|NCT01086410|Secondary|AUC(0-t) and AUC(0-24) for FF on Day 42|Area under the plasma drug concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
71918|NCT01086410|Secondary|Plasma FF and VI Pharmacokinetic (PK) Concentration|Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 42|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
71919|NCT01086410|Secondary|Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|Urine Cortisol (UC) Population: all participants in the ITT Population who did not have protocol deviations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that would affect the interpretation of the results.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
71920|NCT01086410|Secondary|Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42|Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
71921|NCT01086410|Secondary|Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42|Area under the plasma drug concentration-time (AUC[0-24 hour]) curve from time zero (pre-dose) to the last time of quantifiable serum cortisol concentration at 24 hours post-dose on Day -1/1 (Baseline) and Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
71922|NCT01086410|Primary|Ratio From Baseline of the Serum Cortisol Weighted Mean (0–24 Hours) on Day -1/1 (Baseline) and Day 42|"Serum cortisol weighted mean was determined for each participant over the time period 0–12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the 0 time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline."|Day -1/1 (Baseline) and Day 42|Serum Cortisol (SC) Population: all participants in the Intent-to-Treat Population who did not have protocol deviations that were considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors affecting results interpretation. Only those participant available at the specified time points were analzyed.||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
71923|NCT01086384|Secondary|Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36|Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.|Baseline and Week 36|ITT Population. Only those participants available at the indicated time point (Week 36) were analyzed.||Liters||Standard Deviation|Least Squares Mean
71924|NCT01086384|Secondary|Number of Severe Asthma Exacerbations|A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.|Baseline to Follow-up (up to 76 weeks of treatment)|ITT Population||Severe asthma exacerbations|||Number
72046|NCT01084551|Secondary|Clinical Global Impression (CGI) Improvement|"CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||Percentage of Participants|||Number
71925|NCT01086384|Primary|Number of Participants With 1 or More Severe Asthma Exacerbations|Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.|Baseline to Follow-up (up to 76 weeks of treatment)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication.||participants|||Number
71926|NCT01086215|Secondary|Concomitant Treatments Used With the AngioJet® System|The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure|Day 1|||participants|||Number
71927|NCT01086215|Primary|Rethrombosis|The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.|3 Month , 6 Month and 12 Month Follow Up|||participants|||Number
71928|NCT01086215|Primary|Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician.~complete occlusion (>90% occlusion);~substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);~partial occlusion (<50% occlusion AND <3cm in length)~patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value."|Day 1|Intention to Treat (ITT)||Units on a Scale||Standard Error|Mean
71929|NCT01086033|Secondary|Percentage of Participants Who Missed at Least One Dose of Humira|Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.|Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."||percentage of participants|||Number
71930|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 70 Response|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR70 could be calculated at each time point."||participants|||Number
71931|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR50 could be calculated at each time point."||participants|||Number
71932|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR20 could be calculated at each time point."||participants|||Number
71933|NCT01086033|Primary|European League Against Rheumatism (EULAR) Response|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.~A Moderate EULAR Response is defined as either:~an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or~an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.~No Response is defined as either:~an improvement (decrease) in the DAS28 of ≤ to 0.6, or~an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|Safety population;||participants|||Number
71934|NCT01086033|Primary|Disease Activity Score (DAS) 28 Over Time|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
71935|NCT01086033|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant."|3 years|The safety population, including all patients that received at least one dose of the study drug.||participants|||Number
71936|NCT01085968|Secondary|Symbol Digit Modality Test (SDMT)|"Symbol Digit Modality Test (SDMT): Participants are given a key of numbers (1-9) corresponding to symbols for reference.~Task: Participants are given a page of symbols and are instructed to say aloud the number corresponding to each symbol on the page.~This task is timed for completion and the score is reported as the number of symbol to number matching correct in 90 seconds."|time of enrollment and 2 months following enrollment (before and after training)|||Number of Correct Matches in 90 seconds||Standard Deviation|Mean
71937|NCT01085968|Secondary|Functional Dexterity Test (FDT)|"Functional Dexterity test (FDT): a motor dexterity measurement for hands. Task: Pick up and flip wooden pegs on a 4x4 pegboard in a zig-zag pattern; timed. Task is performed 2 times per hand Modified Task: Interchange 2 columns of of pegs (4 pegs each side) simultaneously. No flipping is required.~5 second penalty to time score for 1.) using the pegboard to help with flipping and 2.) supinating of the hand; per occurrence. 10 second penalty to time score for dropping a peg, per occurrence."|time of enrollment and 2 months following enrollment (before and after training)|||Seconds||Standard Deviation|Mean
71938|NCT01085968|Secondary|Task Errors and Variability|Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials|time of enrollment and 2 months following enrollment (before and after training)|||Number of Errors||Standard Deviation|Mean
71939|NCT01085968|Secondary|Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion|"Modified Emory Functional Ambulatory Profile (mEFAP); mobility test Task 1: 5 meter walk on hard surface; timed. Task 2: 5 meter walk on carpeted surface, timed. Task 3: Timed up and go; rise from chair, walk 3 meters, walk back, sit down in chair, timed.~Task 4: Obstacle course, similar to the Timed up and go, with 2 obstacles to be stepped over while walking forward and coming back; timed.~Task 5: Ascend and descend 5 steps of stairs; timed."|time of enrollment and 2 months following enrollment (before and after training)|||Seconds||Standard Deviation|Mean
71940|NCT01085968|Primary|Reaction Time and Variability for Movement Task|Before and after computer training outcome measures: left, right, bimanual external cue reaction time; left, right, bimanual external cue error; left, right, bimanual internally generated reaction time; left, right, bimanual internally generated error for four-digit trials.|time of enrollment and 2 months following enrollment (before and after training)|PD Subjects: total number of subjects: 29, 8 withdrew from study, 2 had incomplete data. CO Subjects: total number of subjects: 25, 4 withdrew from study||milliseconds||Standard Deviation|Mean
71941|NCT01085903|Secondary|Time to Swallow Puree Food|This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).|baseline and after three days of intervention|||seconds||Standard Deviation|Mean
71942|NCT01085903|Secondary|Power Function Exponent for Oral Bolus Estimation|This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention|||exponent||Standard Deviation|Mean
71943|NCT01085903|Secondary|PVT Fastest 10 Percent of Reaction Times|This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention|||milliseconds||Standard Deviation|Mean
71944|NCT01085903|Primary|P50 Percent Habituation Score|This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention|||percentage of change in amplitude||Standard Deviation|Mean
71945|NCT01085825|Primary|Accurate Confirmation of Completed Abortion|Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses|2 weeks - 6 months|||participants|||Number
71946|NCT01085786|Secondary|Compliance Rate|Good compliance is defined as taking equal or more than 90% of eradication medicines|Dec 2010||||||
71947|NCT01085786|Secondary|Adverse Events|by standardized questionnaire|Dec 2010||||||
71948|NCT01085786|Primary|Number of Participants in Which H. Pylori Was Eradicated|evaluate eradication outcome by endoscopy with urease test or urea breath test|Dec 2010|||participants||95% Confidence Interval|Number
71949|NCT01085760|Secondary|Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment||baseline, 12 weeks|Per protocol analysis done||mg/L||Full Range|Median
71950|NCT01085760|Secondary|Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment|The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age [years]) + 0.54 Ln (total bilirubin [mg/dL]) + 0.54 Ln (AST [IU/L]) + 1.24 (variceal bleeding) – 0.84 (albumin [g/dL]). There is no range, minimum, or maximum value but greater values indicate worse disease.|baseline, 12 weeks|Per protocol analysis||units on a scale||Full Range|Median
71951|NCT01085760|Secondary|Change From Baseline in Total Bilirubin Following 12 Weeks Treatment||baseline, 12 weeks|Per protocol analysis done||mg/dl||Full Range|Median
71952|NCT01085760|Primary|Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment||baseline, 12 weeks|The number of participants was based on a per protocol analysis.||U/L||Full Range|Median
71953|NCT01085734|Secondary|Change in Macular Thickness and Macular Volume|OCT central subfield thickness measured in microns|6 months|||microns||Standard Deviation|Mean
71957|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
71958|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
71959|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
71960|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Placebo|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
71961|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
71962|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.||cm||Standard Deviation|Mean
71963|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment|The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant’s condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
71964|NCT01085591|Secondary|Median Time to Resolution of Diarrhea|The median time to resolution of diarrhea is presented for evaluable participants in each treatment group. The time in days from the start of treatment (time of first dose of study drug) to resolution (time of the last UBM on the day before the first of 2 consecutive days of < 4 UBMs and sustained through the second day following the last dose of study drug).|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug, had a confirmed diagnosis of Clostridium difficile infection (CDI), and who achieved resolution of their diarrhea.||Days||95% Confidence Interval|Median
71965|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. If diarrheal symptoms returned, participants were asked to indicate the number of UBM they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week FUP. Strain at Baseline=SAB.|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
71966|NCT01085591|Secondary|Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with investigator assessed clinical response of cure, failure or unable to evaluate is presented and shown separately for participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline. Clinical response was determined by the participant’s condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the EOT. The information to assess clinical response for infection caused by C. difficile BI/NAP1/027 strain at Baseline was collected at any time up to and including Day 12. Strain at Baseline=SAB|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
71967|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period|The number of participants with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. Only subjects deemed a cure at EOT were assessed for recurrence. This is the denominator used for all percentages. If diarrheal symptoms returned, participants were asked to indicate the number of unformed bowel movements (UBM) they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week Follow-up Period (FUP).|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||Participants|||Number
71968|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment|The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).||participants|||Number
71969|NCT01085539|Primary|Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant.|Sat Secs is an oxygen alarm with 5 settings:0,10,25,50,and 100. At each setting,using the units of seconds,it filters nusiance alarms & identifies important alarms that result in the clinicians changing the care of the infant.|4 hours|All patients with complete data||percentage of interventions|||Number
71970|NCT01085513|Secondary|CE-EIA Scores for Dysmotility||within 7 days||||||
71971|NCT01085513|Secondary|Clinical Symptoms||within 7 days||||||
71972|NCT01085513|Secondary|Features Detected by CE-EIA: Contractile Patterns; Non Contractile Patterns - Wall and Tunnel Patterns; Luminal Content - Turbid Pattern; Endoluminal Motion; Capsule Displacement.||within 7 days||||||
71973|NCT01085513|Primary|Test Characteristics (i.e., Sensitivity, Specificity, NPV, PPV) of CE-EIA, as Compared to SB Manometry Which Will be Considered as an Imperfect Gold standard14.||within 7 days|The study was terminated without achieving the needed sample size due to very low recruitment rate. therefore, no statistical analysis has been performed. T|||||
71974|NCT01085500|Secondary|Number of Hernia Repair Subjects With Post-Operative Urinary Retention|Urinary retention is the inability to empty the bladder. This is an educational study for surgeons. The participants in the study are surgeons, and the participant flow, baseline characteristics and first two outcome measures are for the surgeons. During the part of the study reported for the third outcome measure, the first surgical procedure (TEP) after randomization, each surgeon had one subject. Therefore, this outcome measure is for the hernia patients or subjects.|at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night|||Subjects|||Number
71975|NCT01085500|Secondary|Operative Performance|The trained observer and the staff supervising surgeon graded operative performance independently using a global rating scale, Global Operative Assessment of Laparoscopic Skills (GOALS) immediately after each case, (1 rating per case if bilateral repair). The GOALS tool has been shown to be a valid and reliable tool to measure generic laparoscopic skills in the simulated environment and in the operating room, with good agreement between live and video-review ratings. The scores range from 6 to 30, a higher score indicates greater operative performance.|at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two|||units on a scale||Standard Deviation|Mean
71976|NCT01085500|Primary|Participation-Corrected Operative Time|Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time_corrected = time_raw + (1-participation) x time_raw.|at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two|||minutes||Standard Deviation|Mean
72072|NCT01084265|Primary|Number of Participants Who Refused to Take hCG Injection|Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
71977|NCT01085357|Secondary|Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Month 24 postoperative|ITT||percentage of eyes|Participants||Number
71978|NCT01085357|Secondary|Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|ITT||mmHg||Standard Deviation|Mean
71979|NCT01085357|Primary|Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|Intent-to-treat (ITT)||percentage of eyes|Participants||Number
71980|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAES between first dose of study drug administration and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, safety outcome measure could not be performed.|||||
71981|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Best Overall Response|BOR was defined based on Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, Best overall response was not evaluated.|||||
71982|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Circulating Biomarkers||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, circulating biomarkers were not evaluated.|||||
71983|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Circulating Biomarkers in Serum||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Number of subjects enrolled in the safety run-in part of the trial was less and it would not provide sufficient statistical power to perform any analysis. Hence, the biomarker samples were not analyzed as part of the trial.|||||
71984|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Best Overall Response (BOR)|BOR was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|The efficacy analysis set included all subjects who received at least 1 trial drug dose (any of the three FOLFIRI drugs and pimasertib) and had a baseline tumor assessment and at least 1 post-baseline efficacy assessment.||Subjects|||Number
72073|NCT01084265|Primary|Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
72074|NCT01084265|Primary|Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
71985|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of AUC0-inf of Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)|The AUC(0-inf) was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Ratio||Full Range|Median
71986|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of Cmax for Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Ratio of Cmax||Full Range|Median
71987|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Volume of Distribution (Vz f) Pimasertib, (Vz) of Irinotecan and SN-38|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Liter||Full Range|Median
71988|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Clearance (CL/f) of Pimasertib, (CL) Irinotecan and SN-38|Clearance of a drug was a measure of the rate at which drug was metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||Liter per hour||Full Range|Median
71989|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Terminal Half Life (t1/2) of Pimasertib, Irinotecan and SN-38|The t1/2 was defined as the time required for the plasma concentration of pimasertib and irinotecan to decrease 50% in the final stage of elimination.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||hour||Full Range|Median
71990|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib, Irinotecan and SN-38|The AUC(0-inf) of pimasertib and irinotecan was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."||ng/mL*hour||Full Range|Median
71991|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to the Time of Last Observation (AUC0-t) of Pimasertib, Irinotecan and SN-38|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."||(nanogram/milliliter)*hour([ng/mL]*hour)||Full Range|Median
71992|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Time to Reach Maximum Observed Concentration (Tmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."||hour||Full Range|Median
71993|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Maximum Observed Plasma Concentration (Cmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."||nanogram per milliliter (ng/mL)||Full Range|Median
71994|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).||Subjects|||Number
71995|NCT01085331|Primary|Part 2 or Phase 2 Randomised Part: Progression Free Survival (PFS)|PFS was defined as time (in months) from the date of randomization to the first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0) or death for any cause.|From randomization up to first documented disease progression maximum up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, PFS was not evaluated for this study.|||||
71996|NCT01085331|Primary|Part 1 or Safety Run-in Part: Maximum Tolerated Dose (MTD)|MTD was defined as the dose level, at which the treatment-related dose limiting toxicity (DLT) occurred in >1 of 3 subjects or in >1 of 6 subjects. DLT was defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Any Grade >=3 non-hematological toxicity except for Grade 4 asymptomatic increases in liver function tests (LFTs) reversible within 7 days in subjects with liver involvement, Grade 3 asymptomatic increases in LFTs reversible within 7 days in subjects without liver involvement, Grade 3 vomiting controlled with adequate and optimal therapy and prophylaxis, and Grade 3 diarrhea controlled with adequate and optimal anti-diarrhea therapy; any Grade 4 neutropenia lasing >5 days/ febrile neutropenia lasting >1 day; any Grade 4 thrombocytopenia/Grade 3 with bleeding; any treatment delay >2 weeks due to trial treatment-related adverse effects at any dose level and judged to be possibly or probably related to the trial treatment.|Baseline up to Day 28 (Part 1)|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).||mg|||Number
71997|NCT01085318|Other Pre-specified|Time to First Clinical Relapse|Time to First Clinical Relapse|Months|||months||Standard Deviation|Mean
71998|NCT01085318|Other Pre-specified|Clinical Relapses|Clinical Relapses|Over 6 months|||relapses per participant||Standard Deviation|Mean
71999|NCT01085318|Secondary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months|To characterize the effect of Rebif on demyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6|||mm^3||Full Range|Median
72000|NCT01085318|Primary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months|To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6|The analysis were run on the Intent-to-Treat (ITT) set defined as all RRMS subjects with at least one injection of Rebif and all HC who signed the informed consent form. Missing data were not imputed.||mm^3||Full Range|Median
72001|NCT01085214|Other Pre-specified|Level of Key Regulators|The level of key regulators of the MEK/MAPK and PI3K pathways and HSP90 and cell cycle regulators may determine the anti-tumor response to AZD6244 in vivo in multiple myeloma (MM).|Up to 20-30 hours after receiving the first dose of selumetinib||||||
72002|NCT01085214|Other Pre-specified|Changes in Bone Marrow Microenvironment|Effect of AZD6244 on the bone marrow microenvironment in MM.|Baseline to up to 20-30 hours after receiving the first dose of AZD6244||||||
72003|NCT01085214|Secondary|Progression Free Survival (PFS)|Median PFS in months. Progressive Disease (PD): Increase of >= 25% from baseline. Estimated using the method of Kaplan-Meier.|From registration to progression or death, assessed up to 2 years|All participants who received study treatment||months||Full Range|Median
72004|NCT01085214|Secondary|Incidence of Toxicity That May Be Treatment Emergent|Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).|1 year, 11 months|All participants who received study treatment||participants|||Number
72005|NCT01085214|Secondary|Duration of Response|Mean duration of response in months. Estimated using the method of Kaplan-Meier.|From response to disease progression or death, assessed up to 2 years|All participants with response||months||Full Range|Mean
72006|NCT01085214|Primary|Overall Response Rate|Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).|Up to 2 years|All participants who received study treatment||participants|||Number
72007|NCT01085201|Secondary|Pain Levels During a Vaso-occlusive Event in Children and Adults With SCD.|Pain was measured using a standardized pain scale. The scale is a 10-cm visual analogue scale (10 cm-long line printed on white paper), where 0 is no pain and 10 is maximum pain. Participants were asked to indicate their pain level by marking on the line prior to each blood draw.|pre-drug to 54 hours|The number of participants was determined per protocol following a 3+3 design. Stages 1, 2 and 2b were excluded because this outcome measure is specific to the experience of a vaso-occlusive event, which was studied in Stages 3 and 4.||units on a scale||Standard Deviation|Median
72008|NCT01085201|Secondary|Percentage of Activated iNKT Cells and/or Activation Markers on iNKT Cells in Individuals With SCD.|Percentage of activated iNKT cells after receiving a 24-hour infusion of Lexiscan was compared to pre-drug. iNKT cell activation was evaluated using antibodies targeting the p65 subunit of nuclear factor-kappa B (phospho-NF-kB p65). Measures are given as percentage of change in phospho-NF-kB p65 activation in iNKT cells compared to pre-drug after a 24-hour infusion. iNKT cell activation in Stages 1, 2b, and 4 was not analyzed (see analysis population description).|pre-drug to 54 hours|The number of subjects was determined per protocol. Stage 1 was excluded as the goal was to determine the optimal markers for iNKT cells. Only 4 subjects were analyzed in Stage 2 because 24-hour samples were not obtained for 2 subjects. Stages 2b and 4 were not completely analyzed because these stages were completed early after studying 3 subjects.||percentage of change in activation||Standard Deviation|Median
72009|NCT01085201|Primary|Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD.|"Per protocol, Lexiscan was considered safe if well tolerated based on number of DLTs reported. Stage 1 of the study was a 3+3 dose escalation study. Three doses were tested: 0.24 mcg/kg/hr (dose level 0), 0.6 mcg/kg/hr (dose level 1), and 1.44 mcg/kg/hr (dose level 2). Dose escalation continued until 6 participants were treated at the maximum planned dose (dose level 2). We studied a total of 15 patients in Stage 1. In Stages 2 and 3, if at least 2/3 participants tolerated the dose, an additional 3 participants were studied. We studied 6 participants in each of stages 2 and 3. In stage 2b, Lexiscan was studied for a longer (48 hr) duration in 3 participants. In stage 4, Lexiscan was studied in 3 pediatric participants."|30 to 54 hours plus 30-day follow-up|The number of participants was determined per protocol following a 3+3 design. In Stages 2b and 4, we received permission from the FDA, IRB, and DSMB to study only 3 subjects because we did not observe any prior DLT. One patient enrolled in Stage 2b withdrew consent during the infusion due to an unrelated toothache, and was excluded from analysis.||number of DLT|||Number
72010|NCT01085136|Secondary|Objective Response According to RECIST 1.1 in Part A|Objective tumour response was defined as a best overall response of CR or PR as determined by RECIST 1.1 and as assessed by the Investigator. For patients enrolled in Part A, this was to be based on all responses taken from the start of treatment until the start of any new anticancer therapy or disease progression. Objective response was analysed descriptively. The duration of objective response was defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for PFS).|tumour assessment was at screening (-28 days to screening) and every 6 weeks until the first follow-up visit in Part A, up to a total of 10 years.|Treated set - all patients who were documented to have taken at least 1 dose of afatinib 50 mg in Part A.||participants|||Number
72011|NCT01085136|Secondary|Objective Response Rate According to RECIST 1.1 in Part B|Objective tumour response was defined as a best overall response of complete response (CR) or partial response (PR) as determined by RECIST 1.1 and as assessed by the Investigator. For patients enrolled in Part B, a Part B best overall response was to be based on all responses taken from the start of Part B treatment until the start of any new anticancer therapy or disease progression in Part B. The duration of objective response was defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for PFS).|tumour assessment was every 8 weeks until the final follow-up visit in Part B, up to a total of 10 years.|Randomised set - all randomised patients irrespective of whether treated or not||participants|||Number
72012|NCT01085136|Secondary|Overall Survival (OS) as Determined by the Time From Randomization to Death in Part B|Overall survival was calculated as the time from the date of randomisation to the date of death. Patients for whom there was no evidence of death at the time of the analysis were to be censored on the date that they were last known to have been alive.|from the date of randomisation to the date of death, up to a total of 10 years.|Randomised set - all randomised patients irrespective of whether treated or not||months||95% Confidence Interval|Median
72013|NCT01085136|Secondary|Progression Free Survival (PFS) as Determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A|Progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A. PFS from the day of randomisation to the day of progression according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 for patients treated with Afatinib monotherapy.|tumour assessment was at screening (-28 days to screening) and every 6 weeks until the first follow-up visit in Part A, up to a total of 10 years.|Treated set - all patients who were documented to have taken at least 1 dose of afatinib 50 mg in Part A of the trial.||months||95% Confidence Interval|Median
72014|NCT01085136|Primary|Progression Free Survival (PFS) Time as Determined by RECIST 1.1 for Part B.|PFS from the day of randomisation to the day of progression according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 for patients randomised to combination therapy with afatinib plus paclitaxel or to investigators choice of chemotherapy.|Every 8 weeks until the final follow-up visit in Part B, up to a total of 10 years.|Randomised set - all randomised patients irrespective of whether treated or not||months||95% Confidence Interval|Median
72015|NCT01085006|Secondary|Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery||First 24 hours||||||
72016|NCT01085006|Primary|The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward||During the procedure and within 2 hours afterwards|||ml||Full Range|Median
72017|NCT01084759|Secondary|Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||participants|||Number
72018|NCT01084759|Primary|Time to PSA Progression|Time to a PSA increase above the PSA level obtained after 3 months on testosterone treatment over two successive measurements 2 weeks apart.|2 years|||days||Full Range|Median
72019|NCT01084759|Primary|Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.||3 months|||Percentage of Participants||95% Confidence Interval|Number
72020|NCT01084707|Primary|Average Concentration|Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)|During the last dosing interval (hour 11-12 post-dose)|ITT||(ng/ml)||Standard Deviation|Geometric Mean
72021|NCT01084707|Secondary|Nicotine Plasma Concentration|The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment|One hour after start of treatment|ITT||(ng/ml)||Standard Deviation|Geometric Mean
72022|NCT01084707|Secondary|Peak-Trough Fluctuation|Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)|During the last dosing interval (hour 11-12 post-dose)|ITT||Percent Fluctuation||Standard Deviation|Mean
72023|NCT01084707|Secondary|Minimum Plasma Concentration|The minimum nicotine plasma concentration during the last dosing interval (Cmin)|During the last dosing interval (hour 11-12 post-dose)|ITT||(ng/ml)||Standard Deviation|Mean
72024|NCT01084707|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During the last dosing interval (hour 11-12 post-dose)|ITT||(minutes)||Full Range|Median
72025|NCT01084707|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During the last dosing interval (hour 11-12 post-dose)|||(ng/ml)||Standard Deviation|Geometric Mean
72026|NCT01084668|Secondary|Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions|Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|From the time of participant consent until 70 days after last dose of study drug|Analysis was performed on the All Treated population.||participants|||Number
72090|NCT01084005|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24|The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|FAS (NCF)||percentage of patients|||Number
72027|NCT01084668|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).|Inclusion visit (Week 0), Week 4, Week 36, and Week 52|Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively.||units on a scale||Standard Deviation|Mean
72028|NCT01084668|Secondary|Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.||units on a scale||Standard Deviation|Mean
72029|NCT01084668|Primary|Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)|PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0) to Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52.||participants|||Number
72030|NCT01084668|Primary|Psoriasis Area and Severity Index (PASI) Score|Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively.||units on a scale||Standard Deviation|Mean
72031|NCT01084603|Primary|Bioavailability|A measure of how much of the drug reaches a person’s bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug’s blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).|12 hours|||h*ng/ml||Standard Deviation|Geometric Mean
72032|NCT01084603|Secondary|Released Nicotine|The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing|After 30 minutes' chewing|ITT||(ng/ml)||Standard Deviation|Mean
72033|NCT01084603|Secondary|Terminal Elimination Rate Constant|The terminal nicotine elimination rate constant (Lamda z)|During 12 hours after start of administration|ITT||(1/hr)||Standard Deviation|Mean
72034|NCT01084603|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During 12 hours after start of administration|ITT||(hours)||Full Range|Median
72035|NCT01084603|Secondary|Nicotine Plasma Concentration|Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)|During 10 minutes after start of administration|ITT||(h*ng/ml)||Standard Deviation|Geometric Mean
72036|NCT01084603|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During 12 hours after start of administration|ITT||(ng/ml)||Standard Deviation|Geometric Mean
72037|NCT01084551|Secondary|Average Sleep Time in a Week|Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF||Hours||Standard Deviation|Mean
72038|NCT01084551|Secondary|Nocturnal Awakenings Due to RLS Symptoms in a Week|Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of days/week with awakening||Standard Deviation|Mean
72039|NCT01084551|Secondary|Average Duration of RLS Symptoms in the Evening and Night in a Week|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF||Hours||Standard Deviation|Mean
72040|NCT01084551|Secondary|Incidence of RLS Symptoms in the Evening and Night|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of days/week with symptoms||Standard Deviation|Mean
72041|NCT01084551|Secondary|Average Duration of RLS Symptoms|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF||Hours||Standard Deviation|Mean
72042|NCT01084551|Secondary|Incidence of RLS Symptoms|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week* 100%|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of days with RLS symptom||Standard Deviation|Mean
72043|NCT01084551|Secondary|Each Item of IRLS (10 Items)|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).~Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||percentage of participants|||Number
72044|NCT01084551|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"Change of PSQI from baseline to the end of dose-titration/dose-maintenance period.~PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
72047|NCT01084551|Primary|International Restless Legs Syndrome Rating Scale (IRLS) Total Score|"Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
72048|NCT01084538|Secondary|Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.|Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.|Baseline through 12 months|Analysis was based on the number of subjects included in the full analysis set (N=175).||participants|||Number
72049|NCT01084538|Secondary|Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL|The average time (measured in days) to achieve target iPTH levels.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.||Days||Standard Deviation|Mean
72050|NCT01084538|Secondary|Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)|Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.||percentage of participants|||Number
72051|NCT01084538|Primary|Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline||Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.||percentage of participants|||Number
72052|NCT01084278|Primary|Percentage of Colchicine Dose Recovered in Dialysate|The cumulative percentage of the colchicine dose recovered in dialysate.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.||percent dose||Standard Deviation|Mean
72053|NCT01084278|Primary|Dialysis Clearance of Colchicine (CLD)|The dialysis clearance of colchicine, calculated as amount of colchicine recovered in dialysate / AUCt2-t1 where t1 and t2 are the times of the start and end of hemodialysis.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.||L/h||Standard Deviation|Mean
72054|NCT01084278|Primary|Renal Clearance of Colchicine (CLR)|Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t.|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/hr||Standard Deviation|Mean
72055|NCT01084278|Primary|Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time|The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||percent of dose||Standard Deviation|Mean
72056|NCT01084278|Primary|Amount of Colchicine Excreted in Urine (Ae[0-t])|The amount of colchicine excreted in urine during the post-dose collection, calculated as the sum of the amounts in the individual collection intervals (Ae).|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||mg||Standard Deviation|Mean
72057|NCT01084278|Primary|Weight-adjusted Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/hr/kg||Standard Deviation|Mean
72058|NCT01084278|Primary|Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/hr||Standard Deviation|Mean
72059|NCT01084278|Primary|Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L/kg||Standard Deviation|Mean
72091|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|FAS (NCF)||percentage of patients|||Number
72060|NCT01084278|Primary|The Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||L||Standard Deviation|Mean
72061|NCT01084278|Primary|Apparent First-order Terminal Elimination Half-life (t½)|The apparent first-order terminal elimination half-life was calculated as 0.693/Kel.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||hr||Standard Deviation|Mean
72062|NCT01084278|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel)|Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve for colchicine. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero plasma concentrations).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||1/hr||Standard Deviation|Mean
72063|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞)|The area under the plasma concentration versus time curve extrapolated to infinity. AUC 0 - ∞ is calculated as the sum of total AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||ng*h/mL||Standard Deviation|Mean
72064|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration, calculated by the linear trapezoidal method.|Day 1 and Day 15 (ESRD patients only), predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||ng*h/mL||Standard Deviation|Mean
72065|NCT01084278|Primary|Time to Maximum Plasma Concentration (Tmax)|The time to reach the maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||hours||Standard Deviation|Mean
72066|NCT01084278|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.||ng/mL||Standard Deviation|Mean
72067|NCT01084265|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Day 14|Safety analysis set included all participants who received investigational drug for at least one time.||participants|||Number
72068|NCT01084265|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Clinical pregnancy was defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
72069|NCT01084265|Secondary|Average Change of E2 Level in Participants Per Day up to Day 14|The average change was calculated by assessing the E2 levels on 4 timepoints until day 14 (day 1, day 5, day 10, day 14 [hCG administration day]).|up to Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||pg/mL per day||Standard Deviation|Mean
72070|NCT01084265|Secondary|Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||follicles||Standard Deviation|Mean
72071|NCT01084265|Secondary|Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||follicles||Standard Deviation|Mean
72075|NCT01084265|Primary|Number of Participants Who Met Both Index 1 and Index 2|The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.||participants|||Number
72076|NCT01084239|Secondary|Rate of ED Discharge|Direct discharge from Emergency Department|Duration of stay in the hospital during the initial visit|||participants|||Number
72077|NCT01084239|Secondary|Cost-effectiveness|Total cost during index hospitalization|Duration of stay in the hospital during the initial visit|||US Dollars||Standard Deviation|Mean
72078|NCT01084239|Secondary|MACE|Major Adverse Cardiovascular Events, All though these events are called MACE they do not qualify as adverse or serious adverse events. As these events are expected in some individuals in this population. Only MACE that occured within 72 hours after hospital discharge were considered serious adverse events in this trial. There were no such events.|72 hours after discharge up to 28 days after enrollment.|||events|||Number
72079|NCT01084239|Secondary|Healthcare Utilization|Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)|Duration of stay in the hospital during the initial visit|||participants|||Number
72080|NCT01084239|Secondary|Time to Diagnosis||Time from ED arrival to first positive test (all tests except Echocardiography Rest and including troponins ) if discharge diagnosis is ACS, otherwise time to performance of last test (all tests except Echocardiography Rest and including troponins ).|||hours||Standard Deviation|Mean
72081|NCT01084239|Primary|Length of Hospital Stay||Duration of stay in the hospital during the initial visit|||hours||Standard Deviation|Mean
72082|NCT01084148|Secondary|Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B||133 days||||||
72083|NCT01084148|Primary|Treatment Response of Xerosis|"Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale:~0 = smooth skin~= patches of fine, powdery scales~= diffuse ashy appearance with many fine scales~= moderate scaling with beginning cracks~= intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I)."|28 days|One patient in V0034 CR 01B Vehicle arm randomized but not treated||participants|||Number
72084|NCT01084135|Secondary|Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)|The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting. It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales. Raw scores range from 63 to 189. Higher scores suggest that an individual’s executive function skills are more problematic. In this study, the change between each subject’s raw score at Baseline and the Final Visit was computed for the Global Executive Composite. A decline in raw scores from Baseline to the Final Visit indicates improvement.|Baseline and Final (Week 20) visit|All subjects who completed the 20 week period were included in analysis except for 1 subjects whose form was completed incorrectly.||units on a scale||Standard Deviation|Mean
72085|NCT01084135|Primary|Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)|The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject’s ABC at Baseline and the Final Visit was computed. A rise in standard scores from Baseline to the Final Visit indicates improvement.|Baseline & Study termination (Week 20)|All subjects who completed the 20 week period were included in analysis except for 2 subjects whose form was completed incorrectly.||units on a scale||Standard Deviation|Mean
72086|NCT01084083|Secondary|Primary Clinical Response Rate|Primary clinical response rate is defined as the proportion of patients with complete response or partial response at their primary sites after induction therapy. Response status for the primary site was classified by clinical examination using endoscopy. If, however, the clinical response status of the primary was unclear based on endoscopy, then the CT or MRI (required at the end of induction) was used to determine status of the primary. If clinical and radiological evaluation of the primary was unclear, a biopsy was considered at the discretion of the treating physician.|assessed within 14 days after delivery of the third cycle of induction therapy|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
72087|NCT01084083|Secondary|24-months Overall Survival|OS was defined as the time from registration to death, or censored at last date known alive. Kaplan-Meier method was used to estimate the overall survival rate at 24 months.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
72088|NCT01084083|Primary|24-month Progression-free Survival|24-month progression-free survival is defined as the proportion of patients who were alive and progression-free at 24 months post registration. The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites||percentage of participants||95% Confidence Interval|Number
72089|NCT01084005|Secondary|Number of Patients With Rescue Therapy|The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial|week 24|FAS (OC)||Number of patients|||Number
72092|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF)||percentage of patients|||Number
72093|NCT01084005|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 18|FAS (OC)||mg/dL||Standard Error|Mean
72094|NCT01084005|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|FAS (OC)||mg/dL||Standard Error|Mean
72095|NCT01084005|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 6|FAS Observed cases (OC)||mg/dL||Standard Error|Mean
72096|NCT01084005|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin.|Baseline and week 24|FAS (LOCF)||mg/dL||Standard Error|Mean
72097|NCT01084005|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 18|FAS (LOCF)||Percent||Standard Error|Mean
72098|NCT01084005|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 12|FAS (LOCF)||Percent||Standard Error|Mean
72099|NCT01084005|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 6|FAS (LOCF)||Percent||Standard Error|Mean
72100|NCT01084005|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 24|FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
72101|NCT01083979|Secondary|Bladder Appearance|The secondary objective to assess treatment efficacy will compare the number of bladder ulcers pre-treatment to the number of ulcers visualized at 12 weeks, the end of the study.|Baseline to 12 Weeks|||Ulcers|||Number
72102|NCT01083979|Primary|Change in Symptom and Problem Severity|The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative interstitial cystitis (IC). The primary endpoint will be assessed at the end of the study, 8 weeks after the last bladder instillation, and will be measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire. The ICSI is composed of 4 questions that address the occurrence of IC symptoms, specifically urinary urgency, frequency, nocturia, and bladder pain. Scores range from 0 (Not at All) to 5 (Almost Always). The IC Problem Indices questionnaire is also composed of 4 questions. Each question asks the patient to indicate how big a problem each of the 4 symptoms are to them. Scores range from 0 (No Problem) to 4 (Big Problem). Responses to all 8 questions are added together to create a total ICSI-PI score. The total ICSI-PI scores ranges from 0 to 36. A lower score indicates less IC symptoms and/or related problem|Baseline to 12 weeks|||units on a scale|||Number
72103|NCT01083901|Secondary|Change in Lower Body Strength|Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.|16 weeks|||lbs||Standard Error|Mean
72104|NCT01083901|Secondary|Changes in Upper Body Strength.|Strength was measured using the one-repetition maximum method. Upper body strength was a composite of bench press, overhead press, seated row, and lateral pull-down strength.|16 weeks|||lbs||Standard Error|Mean
72105|NCT01083901|Secondary|Change in Total Body Fat Mass|Change from baseline to 16 weeks in total body fat mass.|16 weeks|||kg||Standard Error|Mean
72106|NCT01083901|Primary|Change in Total Body Fat-free Mass|change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)|16 weeks|All participants with baseline and 16 week data were included in the analysis (i.e., intention-to-treat).||kg||Standard Error|Mean
72107|NCT01083849|Secondary|Mean Calcium-Phosphate Product Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||mmol²/l²||Standard Deviation|Mean
72108|NCT01083849|Secondary|Mean Intact Parathormone (iPTH) Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||pmol/L||Standard Deviation|Mean
72109|NCT01083849|Primary|Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 months|Participants with a determined chronic kidney disease (CKD) stage||days||Standard Deviation|Mean
72110|NCT01083849|Secondary|Mean Duration of Disability by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||days||Standard Deviation|Mean
72111|NCT01083849|Secondary|Mean Duration of Hospitalization by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||days||Standard Deviation|Mean
72112|NCT01083849|Secondary|Number of Participants With Elevated Calcium-Phosphorus Product|Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||participants|||Number
72113|NCT01083849|Secondary|Number of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||participants|||Number
72114|NCT01083849|Secondary|Number of Participants With Hypercalcemia|Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.||participants|||Number
72115|NCT01083849|Primary|Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 Months|Participants with a determined chronic kidney disease (CKD) stage||percentage of participants|||Number
72116|NCT01083810|Secondary|Change in Absolute CD4 Cell Count [CD4+ Cells/µL]|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with CD4+ measurements at Baseline and any subsequent time point are included.||CD4+ cells/µL||Standard Deviation|Mean
72117|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA >500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
72118|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
72119|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
72120|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA <50 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.||Percentage of participants|||Number
72121|NCT01083810|Primary|Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs|Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.|Baseline and at any timepoint where testing is possible|All participants with resistance testing at baseline and follow-up are presented.||Participants|||Number
72122|NCT01083771|Secondary|To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet|Post diet waist circumference|8 weeks|||centimeters||Standard Deviation|Mean
72124|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment|||% of participants w/ controlled disease|||Number
72125|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 8|||% of participants w/ controlled disease|||Number
72126|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 4|||% of participants w/ controlled disease|||Number
72127|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|week 2|||% of participants w/ controlled disease|||Number
72128|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and end of treatment (up to 8 weeks)|||Percentage change||Standard Deviation|Mean
72129|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8|||Percentage change||Standard Deviation|Mean
72130|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 4|||percentage change||Standard Deviation|Mean
72131|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|week 2|||Percentage change||Standard Deviation|Mean
72132|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|End of treatment|||percentage of participants|||Number
72133|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 8|||percentage of participants|||Number
72134|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 4|||percentage of participants|||Number
72135|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|week 2|||percentage of participants|||Number
72136|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 8|||ng/L||Standard Deviation|Mean
72137|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and end of treatment (up to 8 weeks)|||mmol/g||Standard Deviation|Mean
72138|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 8|||mmol/g||Standard Deviation|Mean
72142|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4|||mmol/24h||Standard Deviation|Mean
72143|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)|||mmol/L||Standard Deviation|Mean
72144|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8|||mmol/L||Standard Deviation|Mean
72145|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4|||mmol/L||Standard Deviation|Mean
72146|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 8|Per protocol population||participants|||Number
72147|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 4|Per Protocol Population||participants|||Number
72148|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|week 8|Per Protocol Population||participants|||Number
72149|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 4|||ng/L||Standard Deviation|Mean
72150|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|Week 4|Per Protocol Population (based on the Full Analysis Set, but excluding subjects who did not apply any study medication, meet the inclusion criterion concerning adrenal function at baseline, or provide any results for the ACTH-challenge test after receiving study treatment)||participants|||Number
72151|NCT01083758|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8 weeks|||percentage of participants|||Number
72152|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set||Percentage of participants|||Number
72153|NCT01083732|Secondary|Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination|"Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.~Clinically Relevant Abnormalities for Laboratory Parameters were reported."|During the treatment period, Up to 6 days|Treated set||Percentage of participants|||Number
72154|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication- Taste Assessment|The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.|Day 1 (immediately after dosing)|Treated set||Percentage of participants|||Number
72155|NCT01083732|Secondary|Percentage of Patients With Any Adverse Events During the Treatment Period|Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set||Percentage of participants|||Number
72156|NCT01083732|Primary|Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.|Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set||Percentage of participants|||Number
72167|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 951 BS|Plasma concentration of metabolite BIBR 951 BS|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
72218|NCT01083186|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12|The alkaline phosphatase normal range was 40-129 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||IU/L||Standard Deviation|Mean
72157|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
72158|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||hours||Full Range|Median
72159|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)|Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
72160|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
72161|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||hours||Full Range|Median
72162|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)|Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
72163|NCT01083732|Primary|Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)||seconds||Standard Deviation|Mean
72164|NCT01083732|Primary|Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)||seconds||Standard Deviation|Mean
72165|NCT01083732|Primary|Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.|at predose and 2 and 10 h after intake of study medication.|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||seconds||Standard Deviation|Mean
72166|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 1087 SE|Plasma concentration of metabolite BIBR 1087 SE|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
72168|NCT01083732|Primary|Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)|"Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).~Some values are NA because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
72169|NCT01083732|Primary|Plasma Concentration of Free Dabigatran (BIBR 953 ZW).|Plasma concentration of free dabigatran (BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
72170|NCT01083732|Primary|Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)|Plasma concentration of total dabigatran (SUM BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|"Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.~PKS (evaluable cases)"||ng/mL||Geometric Coefficient of Variation|Geometric Mean
72171|NCT01083693|Secondary|C-Reactive Protein|The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
72172|NCT01083693|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
72173|NCT01083693|Secondary|Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
72174|NCT01083693|Secondary|Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
72175|NCT01083693|Secondary|Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness|Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]).||Units on a scale||Standard Deviation|Mean
72176|NCT01083693|Secondary|DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale|The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).|Baseline,months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
72177|NCT01083693|Primary|EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression|"European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).~In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status."|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
72195|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Adults|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4 to Day 28|Adults ages >= 17 years||ng/mL||Standard Deviation|Mean
72196|NCT01083576|Secondary|Detectable Paromomycin or Gentamicin Plasma Levels|Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected|20 days|Adults ages >= 17 years||Participants|||Number
72178|NCT01083693|Primary|SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain|Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [participants who discontinued the study early]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.||Units on a scale||Standard Deviation|Mean
72179|NCT01083693|Primary|RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.||Units on a scale||Standard Deviation|Mean
72180|NCT01083654|Primary|7-day Point-prevalence Smoking Abstinence|Self-reported abstinence (versus smoking) during the past 7 days at the 6-month follow-up time-point, verified by exhaled breath carbon monoxide (CO) measurement (< 10 parts per million CO is indicative of no smoking).|6 months|||Number of abstinent participants|||Number
72181|NCT01083602|Secondary|Over All Survival|Kaplan Meier estimates- median time to event|24 weeks|FAS||Days||95% Confidence Interval|Median
72182|NCT01083602|Secondary|Time to Progression|Time from randomization until objective tumor progression; does not include deaths-- Kaplan-Meier estimates|24 weeks|FAS||Days||95% Confidence Interval|Median
72183|NCT01083602|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the date of first study treatment to first occurrence of documented progressive disease /relapse or death. Time from randomization until disease progression or death by Kaplan-Meier estimates|24 weeks|Full Analysis Set (FAS)||days||95% Confidence Interval|Median
72184|NCT01083602|Secondary|Time to Response (Greater Than or Equal to PR) Based on Investigator Assessment|Time to response is defined as the time from the date of first administration of study treatment to the date of first documented evidence of CR or nCR or PR (whichever status is recorded first). Patients who do not have a response of PR or better by the data cut-off date are censored.|after eight cycyles of treatment (24 weeks)|FAS||Days||Standard Deviation|Mean
72185|NCT01083602|Secondary|Responders to Treatment|The primary endpoint for this phase II study of patients with bortezomib-refractory MM is response after a maximum of 8 cycles of therapy as defined by the modified EBMT criteria.|after eight cycyles of treatment (24 weeks)|Full Analysis Set||participants|||Number
72186|NCT01083602|Primary|Overall Response Rate (PR+nCR+CR)|Overall response rate=(PR+nCR+CR) CR= < 5% plasma cells in bone marrow. No confirmation on bone marrow plasma cell (additional assessment) is needed to document CR except patients with non-secretory myeloma where the bone marrow examination must be repeated after an interval of at least 6 weeks, Absence of M-protein in serum and urine by immunofixation,nCR same as CR without out Absence of M-protein in serum and urine by immunofixation,PR+ 50% reduction of serum M-protein and sofft tissue Plasmacytomas all for more than 6 weeks.|after eight cycyles of treatment (24 weeks)|Full Analysis Set||percentage of participants||95% Confidence Interval|Number
72187|NCT01083576|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults ages >= 17 years with measurable samples.||hr/ML||Standard Deviation|Mean
72188|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.||1/ML||Standard Deviation|Mean
72189|NCT01083576|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Paromomycin Alone Treatment had only 5 measureable samples on Day 1, and WR 279,396 had only 4 measureable samples on Day 20.||hr||Standard Deviation|Mean
72190|NCT01083576|Other Pre-specified|Serum Creatinine Levels|Blood creatinine was measured to assess possible nephrotoxicity associated with aminoglycosides|Day 1 and Day 20|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.||mg/dL||Standard Deviation|Mean
72191|NCT01083576|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.||ng*hr/mL||Standard Deviation|Mean
72192|NCT01083576|Secondary|Pharmacokinetic Parameter: Tmax|Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Both groups had only 6 measureable samples each on Day 1.||hr||Standard Deviation|Mean
72193|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults with measurable samples.||ng/mL||Standard Deviation|Mean
72194|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|Days 1 and 20|Children ages 7 to 16||ng/mL||Standard Deviation|Mean
72197|NCT01083576|Secondary|Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions|Final cure as defined by the primary outcome measure AND and cure of all other lesions by Day 168. (100% re-epithelialization of all ulcerated lesions and resolution of all other type of lesions)|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.||Participants|||Number
72198|NCT01083576|Primary|Number of Participants Who Obtained Final Clinical Cure of Index Lesion|Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion.|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.||Participants|||Number
72199|NCT01083485|Secondary|Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets|To compare the use of rescue analgesia for the 2 groups (OXN 20/10mg tablets and OXY 20mg tablets) during the double blind treatment phase. Rescue medication was given (OXY Immediate Release, 5mg capsules) if the subjects pain score on the (Numeric Rating Scale (NRS), 0 (no pain) to 10 (worst possible pain)), was greater than or equal to 4. The value presented is the mean dose over the double blind phase.|Mean dose during the whole double blind treatment phase (2.5 days)|This is the per protocol population (PP), which is a subset of the full analysis population. The data presented is only for those subjects taking the higher dose (20/10 mg OXN or 20 mg OXY) in the study.||mg of rescue analgesia||Standard Deviation|Mean
72200|NCT01083485|Primary|Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value)|"The primary efficacy variable was the 24hr pain intensity score at rest, on a Numerical Rating Scale (NRS), with 0 = no pain and 10 = worst possible pain. This was assessed 1 hour after dosing on Day 1 (evening only), Day 2(morning and evening) and Day 3 (morning only). The primary efficacy end point (absolute change from baseline) was analysed on the per protocol (PP) data. The mean of these scores is shown as a value that is a mean change (a decrease in pain score) from the baseline value."|Mean of 24 hour pain intensity (absolute change from baseline)|The primary efficacy end point (absolute change from baseline) was analysed on the PP data using a mixed model repeated measures of analysis of covariance (RMANCOVA).||Units on a scale||95% Confidence Interval|Mean
72201|NCT01083472|Primary|Hernia Occurrence|Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.|Month 12 after repair|Due to early termination of the study and the low enrollment number (only 37 subjects out of the planned 200 subjects being enrolled), all planned analyses of study endpoints were not performed. The only study results obtained focused on safety. Due to the small sample size these safety results should be interpreted with caution.|||||
72202|NCT01083316|Secondary|Number of Participants Surviving at 5 Years||5 years||12/2018||||
72203|NCT01083316|Primary|Number of Participants Proceeding to Transplant Following Induction||2 months|||Participants|||Count of Participants
72204|NCT01083316|Primary|Number of Participants Surviving at 100 Days Post Transplant||100 days|||Participants|||Count of Participants
72205|NCT01083316|Primary|Number of Participants With Disease Response|Complete response: Normal serum free light chain ratio and Negative serum and urine immunofixation electrophoresis Very good partial response: Difference in serum free light chains less than 40 mg/L Partial Response: >50% Reduction in the difference in serum free light chains|One year|||Participants|||Count of Participants
72206|NCT01083199|Secondary|Bladder Neck Contracture (BNC) Rate||Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal||||||
72207|NCT01083199|Secondary|Incontinence Rate and I-QOL Score||Baseline, 6-week, 6 and 12-month evaluations||||||
72208|NCT01083199|Secondary|Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits||7 and 14 days post-Device placement||||||
72209|NCT01083199|Secondary|Intraoperative/Postoperative Parameters||At Device placement||||||
72210|NCT01083199|Primary|Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement|"Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window.~The following defines the timeframe of each removal attempt:~7-day window (7-10 days post-implant)~14-day window (13-15 days post-implant)~21-day window (19-21 days post-implant)"|7-21 days post-Device placement|||participants with device removal by 21d|||Number
72211|NCT01083199|Primary|Successful Device Placement|Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.|During Radical Prostatectomy|||participants|||Number
72212|NCT01083186|Secondary|Homocysteine Values Throughout the Study|The homocysteine normal range 3.5-20 μmol/L.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=the number of participants with evaluable data at given time-points.||μmol/L||Standard Deviation|Mean
72213|NCT01083186|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12|The CRP normal range was 0-0.6 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
72214|NCT01083186|Secondary|Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12|The HDL-C normal range was 35-90 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
72215|NCT01083186|Secondary|Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12|The LDL-C normal range was 0-150 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
72216|NCT01083186|Secondary|Change From Enrollment in Triglyceride Levels at Months 6 and 12|The normal range for triglycerides was 0-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
72217|NCT01083186|Secondary|Change From Enrollment in Total Cholesterol Levels at Months 6 and 12|The total cholesterol normal range was 130-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mg/dL||Standard Deviation|Mean
72221|NCT01083186|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12|The aspartate aminotransferase normal range was 11-38 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||IU/L||Standard Deviation|Mean
72222|NCT01083186|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12|The alanine aminotransferase normal range was 11-43 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||IU/L||Standard Deviation|Mean
72223|NCT01083186|Secondary|Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study|The eGFR normal range was 90-120 mL/min/1.73m^2.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.||mL/min/1.73m^2||Standard Deviation|Mean
72224|NCT01083186|Secondary|Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study|Change in CKD stage throughout the study period was assessed by the estimated glomerular filtration rate (eGFR) levels recorded by the physicians at each study time point. Classification of eGFR into CKD stages as follows: CKD stage 2: 60-89 mL/min/1.73m^2; CKD stage 3: 30-59 mL/min/1.73m^2; CKD stage 4: 15-29 mL/min/1.73m^2; CKD stage 5: <15 mL/min/1.73/m^2. Table presents the number of participants by stage at each study visit.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.||participants|||Number
72225|NCT01083186|Secondary|Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs)|In order to establish the safety profile of oral paricalcitol in daily clinical practice, non-serious adverse events (nSAEs) and serious adverse events (SAEs) were collected during the course of the study. An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.|From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.|All participants||participants|||Number
72226|NCT01083186|Secondary|Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study|The HbA1c normal range was 4.3-6.1%.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.||percent||Standard Deviation|Mean
72227|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 12|The values “-, Trace, +, ++, and +++” are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.|Baseline, Month 12|Number of participants with evaluable data at both Baseline and Visit 5 (12 Months Post-Enrollment)||participants|||Number
72228|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 6|The values “-, Trace, +, ++, and +++” are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.|Baseline, Month 6|Number of participants with evaluable data at both Baseline and Visit 3 (6 Months Post-Enrollment)||participants|||Number
72229|NCT01083186|Secondary|Number of Participants With Serum Phosphorus Level Abnormalities|Normal serum phosphorus range was 2.7-4.6 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point||participants|||Number
72230|NCT01083186|Secondary|Number of Participants With Serum Calcium Level Abnormalities|Normal serum calcium range was 8.4-10.2 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point.||participants|||Number
72231|NCT01083186|Secondary|Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range|Number of participants with iPTH levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines at each study measurement after oral paricalcitol treatment onset. K/DOQI treatment guidelines: CKD Stage 3: 35–70 pg/mL; CKD Stage 4: 70–110 pg/mL during a 12-month period of treatment with oral paricalcitol.|Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=participants with evaluable data at given time point.||participants|||Number
72232|NCT01083186|Secondary|Mean Duration of Effect Sustainability (Months)|The effect was considered sustainable if: the participant’s intact parathormone (iPTH) value remained equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL); or iPTH levels continued to decrease 30% from the previous available measurement.|Measured from start of study, up to a maximum of 12 months|All evaluable participants||months||Standard Deviation|Mean
72233|NCT01083186|Secondary|Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels|The time to attain the first lower iPTH levels was considered as the time from the date of oral paricalcitol treatment onset until the date when any of the following conditions were initially met: a 30% reduction from iPTH levels prior to treatment onset had been achieved, for patients who were still outside the target range; or iPTH levels equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL; CKD Stage 5: ≤ 300 pg/mL).|Measured from start of study, up to a maximum of 12 months|Subset of participants with baseline CKD stage ≥ 3 as well as with available iPTH values greater than the upper limit of the target range, prior to paricalcitol treatment onset. Target range for this specific analysis was defined based on patient’s CKD stage (per baseline eGFR) prior to paricalcitol treatment onset.||months||95% Confidence Interval|Median
72234|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Participants with renal transplantation history. n=number of participants with available data at given time-point.||pg/mL||Standard Deviation|Mean
72235|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Overall study population. n=number of participants with available data at given time-point.||pg/mL||Standard Deviation|Mean
72236|NCT01083173|Primary|Percentage of Participants With Viral Load Below 50 Copies/mL|Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 48|Participants with available data||percentage of participants|||Number
72237|NCT01083173|Secondary|Mean Time to Treatment Failure|Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48.|From baseline through weeks 24 and 48|Participants with available data||days||Standard Error|Mean
72238|NCT01083173|Secondary|Percentage of Participants With Confirmed Viral Resistance|Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.|From baseline through weeks 24 and 48|Participants with available data||percentage of participants|||Number
72239|NCT01083173|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts|Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.|From baseline to Weeks 24 and 48|Participants with available data||cells/mm˄3||Standard Deviation|Mean
72240|NCT01083173|Secondary|Change From Baseline in Viral Load|This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.|Week 24 & 48||||||
72241|NCT01083173|Primary|Percentage of Participants With Viral Load Below 400 Copies/mL|Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 24|Participants with available data||percentage of participants|||Number
72242|NCT01083173|Primary|Number of Participants Who Interrupted or Discontinued Kaletra Treatment|At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).|Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment|Participants with available data||participants|||Number
72243|NCT01083173|Primary|Number of Participants With Adverse Events|Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.|From the start of treatment until 30 days after the last dose, up to 52 weeks|Participants with available data||participants|||Number
72244|NCT01083160|Secondary|Evaluate the Compliance and Clinical Tolerability With Adalimumab|To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section.|Baseline to Week 24|Analysis population included all participants enrolled in the study who took at least one dose of adalimumab.||Participants|||Number
72245|NCT01083160|Primary|Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)|Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.||Units on a scale||Standard Deviation|Mean
72246|NCT01083160|Primary|Tender Joint Count and Swollen Joint Count|The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.||Joints||Standard Deviation|Mean
72247|NCT01083160|Primary|DAS28 (Disease Activity Score in 28 Joints)|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to each visit is presented."|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.||units on a scale||Standard Deviation|Mean
72248|NCT01083121|Secondary|Physician's Global Assessment for Effectiveness|The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.|After 3-month treatment|Effectiveness evaluation was performed in 1,471 participants who received adalimumab for at least 3 months and in whom investigator's assessment at 3 months was available. No participants were available in the Psoriasis group for effectiveness evaluation.||participants|||Number
72255|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 0 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 1 minute post-dose (Hour 0) on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
72249|NCT01083121|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|From Baseline until up to 70 days after the 3 month study period (total of 160 days).|Safety analysis population||participants|||Number
72250|NCT01082965|Secondary|Change From Baseline in CogState Test Battery at Hour 5 on Day 1 and at Hour 0, 5 on Day 8|Computerized test battery used to assess detection and identification task. CogState detection task: a measure of simple reaction time, provided valid assessment of psychomotor function. Participants were required to press a “YES” response key as soon as they detected an event (a card turning face up presented in center of the computer screen). The software measured the response time to detect each event. CogState identification task: measure of choice reaction time, provided a valid assessment of visual attention. Participants were required to decide “YES” or “NO” as to whether the event met a predefined and unchanging criterion (is the color of the card red?) while the event (a card turning face up) occurred in the center of the computer screen. The software measured the speed and accuracy of each response.|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specific time points for each arm group, respectively.||log10 milliseconds||Standard Deviation|Mean
72251|NCT01082965|Secondary|Change From Baseline in Rey Auditory Verbal Learning Test (RAVLT): Immediate and Delayed Recall at Hour 5 on Day 8|RAVLT, in immediate recall (IR) list of 15 words (list A) was read aloud to participant 5 times followed by a test of spontaneous retrieval (A1 to A5). After fifth attempt a list of interference, comprising 15 words (list B) was read to participant followed by its retrieval (B1). After attempt B1 examiner asked individual to recall words from list A, without reading it again (A6). Score range: 0-105, higher scores=less impairment. Delayed recall (DR):after a 20-minute interval examiner asked individual to remember words from list A without reading this list; in recognition performance a list comprising 15 words from list A, 15 words from list B, 20 distracting words (similar to words in list A, B) was read to individual. Upon each word read aloud, individual asked to indicate if it belonged to list A, or not. Score range: 0-30, higher scores=less impairment.|Baseline, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
72252|NCT01082965|Secondary|Change From Baseline in CogState Continuous Paired Associate Learning (CPAL) at Hour 5 on Day 1 and at Hour 1, 5 on Day 8|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. After 4 pictures were placed correctly, second round started. In second round pictures remain in the same locations, but their order of presentation in the center of the screen was different to that of the first round (randomized). The same process was repeated for round 3 and round 4. The outcome was the number of errors made in correctly placing each of the 4 patterns in their location 4 times.|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.||errors||Standard Deviation|Mean
72253|NCT01082965|Secondary|Change From Baseline in Arterial Spin Label (ASL) Perfusion at Hour 4 on Day 1 and at Hour 0, 4 on Day 8|Perfusion in anterior cingulate cortex, medial prefrontal cortex, precuneus, inferior parietal cortex and other regions of interest (whole brain gray, superior, medial and inferior temporal cortex; inferior and superior prefrontal cortex; insula, amygdala, thalamus, basal ganglia, hippocampus, Landau) was measured by ASL technique. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for relative perfusion rate. Relative perfusion rate is defined as the absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1, 1 minute post-dose (Hour 0), 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
72254|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
72274|NCT01082614|Secondary|Quality of Recovery Score|Measure of quality of recovery using scoring system; assessed by patient and nursing team|From end of surgery to within one month||||||
72275|NCT01082614|Primary|Length of Postoperative Hospital Stay|time in days from end of surgery to hospital discharge|within one month|||Days||Full Range|Mean
92757|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])||Baseline up to Month 7|||percentage of participants|||Number
72256|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 1|Posterior cingulate cortex perfusion was measured by arterial spin labeling (ASL). ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
72257|NCT01082952|Secondary|Fold Increase in ASM Cells Proliferation Following Treatment With Cysteinyl Leukotrienes|The effect of Eosinophil release of Cysteinyl Leukotrienes on ASM proliferation was determined using blocking agents. This was determined using Ki-67 staining and flowcytometry.|one day|Eosinophils were collected from all the participants and used to trigger ASM proliferation.||Fold increase in ASM proliferation||Standard Deviation|Mean
72258|NCT01082952|Primary|Fold Increase in ASM Proliferation Following Incubation With Eosinophils.|Airway Smooth Muscle (ASM) cell proliferation was measured 24 hrs following their co-culture with eosinophil. This was determined using Ki-67 staining and flowcytometry. The fold increase in ASM proliferation was then determined.|one day|The number of participants for each group was determined to insure proper statistical significance when analysing the effect of isolated eosinophils on ASM cells proliferation||Fold increase in ASM cell proliferation||Standard Deviation|Mean
72259|NCT01082939|Primary|Number of Participants With an Overall Response|Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|6 cycles of treatment (28 days per cycle)|||Participants|||Number
72260|NCT01082874|Secondary|Individual Secondary Outcomes at 1 Year|All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.|1 year||||||
72261|NCT01082874|Secondary|Composite Outcome at 1 Year|All-cause mortality, nonfatal MI, and nonfatal stroke.|1 year||||||
72262|NCT01082874|Secondary|Safety Outcomes in Clonidine Trial|Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.|30 days||||||
72263|NCT01082874|Secondary|Safety Outcomes in ASA Trial|Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.|30 days||||||
72264|NCT01082874|Secondary|Composite Outcome by ASA Stratum|Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.|30 days||||||
72265|NCT01082874|Secondary|Individual Secondary Outcomes|All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.|30 days||||||
72266|NCT01082874|Secondary|Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke||30 days||||||
72267|NCT01082874|Primary|All-cause Mortality and Nonfatal MI||1 year||||||
72268|NCT01082874|Primary|Composite of All-cause Mortality and Nonfatal MI||30 days|||participants|||Number
72269|NCT01082640|Secondary|Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State|Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.||hr*µg/mL||Standard Deviation|Mean
72270|NCT01082640|Secondary|Mean Clearance (CL/F) of Febuxostat at Steady State|Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.||liters/hour||Standard Deviation|Mean
72271|NCT01082640|Secondary|Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12|Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory.|Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. A patient was included in the analysis only when there was at least 1 value during the double-blind treatment period. Missing data were imputed as carrying forward the last observed post-baseline value.||percentage of participants|||Number
72272|NCT01082640|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory).|Baseline and Month 12|Full analysis set with available data at Baseline. and at least 1 post-baseline value. Missing data was imputed as carrying forward the last post-baseline value.||mL/min/1.73m²||Standard Error|Least Squares Mean
72273|NCT01082640|Primary|Change From Baseline to Month 12 in Serum Creatinine|Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.|Baseline and Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. Only patients with both a baseline value and at least 1 value during the double-blind treatment period are included in the analysis. Missing data were imputed as carrying forward the last observed post-baseline value.||mg/dL||Standard Error|Least Squares Mean
72276|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
72277|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
72278|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
72279|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12|The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12|||Scores on a scale||Standard Deviation|Mean
72280|NCT01082588|Primary|Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12|"The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.~The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, week 12|One participant from the placebo group refused to complete the MATRICS assessment at week 12; therefore, we could only analyze 24 placebo participants for the final analysis.||Scores on a scale||Standard Deviation|Mean
72281|NCT01082588|Primary|Change in C-Reactive Protein (CRP) From Baseline to Week 12||Baseline, week 12|||mg/L||Standard Deviation|Mean
72282|NCT01082588|Primary|Change in LDL-cholesterol Between Baseline and Week 12||Baseline, week 12|One participant from the pravastatin group and two from the placebo group had triglyceride levels above 400. Per Massachusetts General Hospital Laboratories policy, LDL is not run as a part of the complete metabolic panel (CMP) when triglycerides are above 400, and therefore could not be included in the final analysis.||mg/dl||Standard Deviation|Mean
72283|NCT01082575|Primary|Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.|Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.|5 days|93 evaluable patients out of 100 enrolled.||participants|||Number
72284|NCT01082575|Secondary|Number of Participants With Adverse Events (AE) Caused by no Breathing|Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing|Five Nights|All enrolled patients||participants|||Number
72285|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Urine|In urine, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percentage of radioactive dose|||Number
72286|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Feces|In feces, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percentage of radioactive dose|||Number
72287|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Plasma|Identification was done by Radio-High Performance liquid chromatography (HPLC) chromatogram. Relative abundance (profiling) of metabolites in chromatogram were determined by dividing sum of radioactive content of fractions contributing to particular peak by sum of radioactive content of all fractions constructing the radio chromatogram. Metabolites accounting for an average of greater than or equal to (>=) 10% of total recoverable radioactivity in plasma were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percentage of recovered radioactivity|||Number
72288|NCT01082380|Primary|Overall Cumulative Percent Recovery of Radioactivity|Overall cumulative percent of radioactive dose recovered in urine, feces and toilet tissue at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Pre-dose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose for urine and Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose for feces|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||Percent recovery of radioactivity||Standard Deviation|Mean
72289|NCT01082380|Primary|Total [14C] Data in Feces|Cumulative amount excreted in feces at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq||Standard Deviation|Mean
72290|NCT01082380|Primary|Total [14C] Data in Urine|Cumulative amount excreted in urine at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq||Standard Deviation|Mean
72291|NCT01082380|Primary|Apparent Volume of Distribution of Radioactivity in Whole Blood (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L||Standard Deviation|Geometric Mean
72292|NCT01082380|Primary|Apparent Oral Clearance of Radioactivity From Whole Blood (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L/hr||Standard Deviation|Geometric Mean
72293|NCT01082380|Primary|Decay Half-life (t1/2) of Radioactivity in Whole Blood|Decay half life (t1/2) is the time measured for the concentration to decrease by one half in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||hr||Standard Deviation|Mean
72294|NCT01082380|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Radioactivity in Whole Blood|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
72295|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Radioactivity in Whole Blood|Area under the concentration time-curve from zero to the last measured concentration (AUClast) in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
72296|NCT01082380|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in Whole Blood|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||hr||Full Range|Median
72297|NCT01082380|Primary|Maximum Observed Concentration of Radioactivity in Whole Blood (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq/mL||Standard Deviation|Geometric Mean
72298|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma Radioactivity|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L||Standard Deviation|Geometric Mean
72299|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma Radioactivity|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||L/hr||Standard Deviation|Geometric Mean
72300|NCT01082380|Primary|Decay Half Life (t1/2) of Radioactivity in Plasma|Plasma decay half-life is the time measured for the plasma radioactivity concentration to decrease by one half. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||hr||Standard Deviation|Mean
72301|NCT01082380|Primary|Area Under the Plasma Radioactivity Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in plasma. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
72327|NCT01082081|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72302|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Radioactivity Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||ng-eq*hr/mL||Standard Deviation|Geometric Mean
72303|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Radioactivity Concentration (Tmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||hr||Full Range|Median
72304|NCT01082380|Primary|Maximum Observed Concentration in Plasma Radioactivity (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.||nanogram-equivalent/milliliter(ng-eq/mL)||Standard Deviation|Geometric Mean
72305|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine Expressed as Percent of Dose From Time Zero to Infinite Time [Ae(%)]||Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||Percent dose of unchanged drug||Standard Deviation|Geometric Mean
72306|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to Infinite Time (Ae)|Ae = concentration of unchanged drug excreted in the urine multiplied by volume of unchanged drug excreted in urine.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||mg||Standard Deviation|Geometric Mean
72307|NCT01082380|Primary|Renal Clearance (CLr) of PF-02341066|CLr is the volume of plasma from which a substance is completely removed by the kidney in a given amount of time.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||L/hr||Standard Deviation|Geometric Mean
72308|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||L||Standard Deviation|Geometric Mean
72309|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma PF-02341066|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||L/hr||Standard Deviation|Geometric Mean
72310|NCT01082380|Primary|Plasma Decay Half Life (t1/2)|Plasma Decay half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||hr||Standard Deviation|Mean
72311|NCT01082380|Primary|Area Under the Plasma Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||ng*hr/mL||Standard Deviation|Geometric Mean
72312|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration (AUClast).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||ng*hr/mL||Standard Deviation|Geometric Mean
72313|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||hr||Full Range|Median
72314|NCT01082380|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (hrs), 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.||ng/mL||Standard Deviation|Geometric Mean
72315|NCT01082367|Secondary|Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period|Sputum/throat swab cultures were assessed.|Day 91|Participants from the ITT population, who were tested for microbiology, were included in the analysis.||Percentage of participants|||Number
72316|NCT01082367|Secondary|Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 91|Cross-over participants from the ITT population were analyzed.||Percentage of participants|||Number
72317|NCT01082367|Primary|Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 29|Intent-to-treat (ITT): The ITT included all randomized participants who received at least dose of study treatment.||Percentage of participants|||Number
72318|NCT01082328|Secondary|Mean Change From Baseline in Blood Phenylalanine-to-tyrosine Ratio|Phenylalanine-to-tyrosine ratio is the best indicator of dopamine availability in PKU. The change in blood phenylalanine-to-tyrosine ratio at Day 28 was calculated as blood phenylalanine-to-tyrosine ratio at Day 28 minus blood phenylalanine-to-tyrosine ratio at Baseline.|Baseline, Day 28|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.||Ratio||Standard Deviation|Mean
72319|NCT01082328|Secondary|Percentage of Early-, Late- and Partial-Responders According to Phenotype|The PKU is categorized as per phenotype into classical PKU: (blood Phe levels > 1200 mcmol/l), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild HPA (blood Phe levels 300 to 600 mcmol/l). Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Percentage of participants|||Number
72320|NCT01082328|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes|The Phenylketonuria (PKU) is categorized as per phenotype into classical PKU: (blood Phe levels greater than [>] 1200 micromole per liter [mcmol/l]), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild Hyperphenylalaninaemia (HPA) (blood Phe levels 300 to 600 mcmol/l).|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.||Percentage of participants|||Number
72321|NCT01082328|Secondary|Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®|Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment. Non-responders defined as percentage of participants with a Phe level reduction of less than 10 percent within 28 +/- 1 days.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.||Percentage of participants||95% Confidence Interval|Number
72322|NCT01082328|Secondary|Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Day 42 +/- 3|Safety population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.||Participants|||Number
72323|NCT01082328|Primary|Percentage of Participants With at Least 30 Percent Reduction From Baseline in Blood Phenylalanine (Phe) Level|Response to treatment was defined as 30 percent reduction from Baseline in blood phenylalanine (Phe) Level during the 28 +/- 1 days.|Baseline up to Day 28 +/- 1|Full analysis set (FAS) population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.||Percentage of participants||95% Confidence Interval|Number
72324|NCT01082159|Primary|Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).|The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Month 6|All participants at month 6 who completed all questionnaire fields necessary to analyze PCS data according to guidelines.||units on a scale||95% Confidence Interval|Mean
72325|NCT01082159|Primary|Function as Measured Subjectively by the Oswestry Disability Index Questionnaire|Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Month 6|All available patients at 6 months are reported below.||units on a scale||95% Confidence Interval|Mean
72326|NCT01082159|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|"The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.~The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value."|Baseline and Month 6|All available participants who reported Month 6 outcomes are included in this analysis.||units on a scale||95% Confidence Interval|Mean
72328|NCT01082081|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72329|NCT01082081|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72330|NCT01082081|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72331|NCT01082081|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72332|NCT01082081|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72333|NCT01082081|Secondary|Total Pain Relief (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72334|NCT01082081|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72348|NCT01081886|Primary|Post-operative Pain|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
72349|NCT01081873|Secondary|Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline|The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
79715|NCT01003184|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||kilograms||Standard Error|Least Squares Mean
72335|NCT01082081|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
72336|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours|Percentage of participants who took rescue medication during 2 to 6 hours|Within 2 to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
72337|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication Within 2 Hours|Percentage of participants who received rescue medication within 2 hours|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.||Percentage of participants|||Number
72338|NCT01082081|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants was calculated.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.||minutes||Full Range|Median
72339|NCT01082081|Secondary|Time to Onset of Meaningful Pain Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
72340|NCT01082081|Secondary|Time to Confirmed First Perceptible Pain Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
72341|NCT01082081|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 6 hours post dose|||Units on a scale||Standard Deviation|Mean
72342|NCT01081951|Secondary|Percentage Change in Tumour Size|The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.|Week 9 (+/- 1 week)|FAS, but including only patients with target lesions at baseline||Percentage change||Standard Error|Least Squares Mean
72343|NCT01081951|Secondary|Overall Survival (OS)|OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)|FAS||Participants (Number of deaths)|||Number
72344|NCT01081951|Primary|Progression Free Survival (PFS)|PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).|Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)|Full Analysis Set (FAS)||months||95% Confidence Interval|Median
72345|NCT01081912|Secondary|Mean Change of the Clinic NRS Pain Intensity|The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)|Baseline to Day 85 visit||||||
72346|NCT01081912|Primary|Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).|Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.|Baseline to Day 85 (Treatment Phase)|The primary efficacy analysis used the Intent to treat (ITT) population which included all 302 randomized subjects.||units on a scale||Standard Deviation|Mean
72347|NCT01081886|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
72350|NCT01081873|Secondary|Epidemiological Data: Bone Scan at Baseline|The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
72351|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.|N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
72352|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test|In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
72353|NCT01081873|Secondary|Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.|The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
72354|NCT01081873|Secondary|Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.|The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
72355|NCT01081873|Secondary|Epidemiological Data: PSA at Baseline|The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for PSA at baseline was available for 2,532 patients.||ng/mL||Full Range|Median
72356|NCT01081873|Secondary|Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.|Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.||participants|||Number
72357|NCT01081873|Secondary|Epidemiological Data: Race|The number of participants by race at baseline is presented.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients.||participants|||Number
72358|NCT01081873|Secondary|Epidemiological Data: Mean Age|The mean age of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.||years||Standard Deviation|Mean
72359|NCT01081873|Secondary|Epidemiological Data: Mean Weight|The mean weight of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.||kg||Standard Deviation|Mean
72360|NCT01081873|Secondary|Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)|The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details.|Baseline to disease progression or 24 months, whichever came first|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded.||participants|||Number
72361|NCT01081873|Primary|Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.|Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
72362|NCT01081873|Primary|Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months|The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and < 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.|time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
72400|NCT01081769|Secondary|Clinical Global Impression-Change (CGI-C)|The Clinical Global Impression-Change (CGI-C) rating scale is used to rate the change in severity of the patient's illness compared to baseline (day 1 of core phase) on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Month 24 and endpoint|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||percentage of participants|||Number
72363|NCT01081873|Primary|Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit|Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.|month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
72364|NCT01081873|Primary|Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit|The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||ng/mL||Standard Deviation|Mean
72365|NCT01081873|Primary|Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit|The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.||participants|||Number
72366|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
72367|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
72368|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mmHg||Standard Error|Least Squares Mean
72369|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
72370|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
72371|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
72372|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)|The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percentage of patients|||Number
72373|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
72374|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
72375|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mmHg||Standard Error|Least Squares Mean
72376|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent change||Standard Error|Least Squares Mean
72377|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
72378|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||mg/dL||Standard Error|Least Squares Mean
72379|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (Main Study)|The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percentage of patients|||Number
72380|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent||Standard Error|Least Squares Mean
72381|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values||Percent||Standard Error|Least Squares Mean
72382|NCT01081795|Secondary|Short Form-36 Health Survey (SF-36) Score|The SF-36 is a survey of participant health. It consists of 8 scaled scores, which are weighted sums of the questions in their section. The 8 sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each item is scored on a 0-100 range so that total score ranges from 0-100 with high score indicating more favorable health state. Final evaluation was done at Day 155 or at discontinuation for those participants who discontinued before Day 155.|Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW])|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
72383|NCT01081795|Secondary|Percentage of Participants With Response to Study Treatment|Responders were the participants who had at least 50 percent reduction in the average number of monthly migraine attacks.|Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Percentage of participants|||Number
72384|NCT01081795|Secondary|Change From Baseline in the Average Number of Rescue Drug Treatment Days at Month 6|Rescue medications are medicines that may be administered to the participants when efficacy of study drug is not satisfactory, or the effect of study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, NSAIDs, ergotamines, triptans and anti-emetics. Average at Month 6 was calculated by dividing total number of rescue drug treatment days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Month 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Error|Least Squares Mean
72385|NCT01081795|Secondary|Average Number of Rescue Drug Treatment Days|Rescue medications are administered to participants when efficacy of study drug is not satisfactory, or effect of study drug is too great and is likely to cause a hazard to participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), ergotamines, triptans and anti-emetics (drug used to stop vomiting). Average at baseline was calculated by dividing total number of rescue drug treatment days until baseline by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
72386|NCT01081795|Secondary|Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period|The change from baseline in average number of migraine attacks (as per 24-hour rule) over Week 19 to Week 22 period was calculated by subtracting the baseline value from the average value of the Week 19 to Week 22 period.|Baseline (28 days before randomization), Week 19 to Week 22 Period|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Error|Least Squares Mean
72387|NCT01081795|Secondary|Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6|As per 48-hour rule, if the symptom of pain due to migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, the 2 migraine attacks should be considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
72388|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attacks (According to the Diagnostic Criteria of the International Headache Society) at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attacks until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
72389|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6|Headache days were the days when at least 30-minute migraine and non-migraine headache occurred and were calculated from the headache diaries kept by the participants. Average at given month was calculated by dividing total number of headache days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
72390|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attack days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Days||Standard Deviation|Mean
72391|NCT01081795|Primary|Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6|As per 24-hour rule, if symptom of pain due to migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If the interval between latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks should be considered as 1 migraine attack. If the onset of migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if aura had started. Mean change was calculated by subtracting baseline value from the mean of 6 months value.|Baseline (28 days before randomization) through Month 6|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.||Migraine attacks||Standard Deviation|Mean
72392|NCT01081769|Primary|Number of Participants With a Relapse Event|Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator’s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (“much worse”) or 7 (“very much worse”) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.|from baseline (Day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||number of participants|||Number
72393|NCT01081769|Secondary|Change From Baseline in Physician’s Treatment Satisfaction|Physician’s treatment satisfaction was assessed using the physician’s treatment satisfaction scale which is designed to rate 4 aspects of treatment (efficacy, safety, mode of administration, and overall satisfaction), each on a scale ranging from 1 (extremely satisfied) to 7 (extremely dissatisfied).|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72394|NCT01081769|Secondary|Change From Baseline in Patient’s Treatment Satisfaction|Patient’s satisfaction with medication was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is divided into 4 subscales (effectiveness, side effects, convenience, and global satisfaction), with the value of each subscale ranging from 0 to 100. Higher scores indicate greater treatment satisfaction.|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72395|NCT01081769|Secondary|Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score|The SWN-S is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). The total score ranges from 20 to 120 with higher score indicating greater subjective well-being.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72396|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score|"The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A higher score indicates an improvement in health in the Health Status Index."|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72397|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score|The EQ-5D VAS records the respondent’s self-rated health on a vertical, visual analog scale, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual respondent.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72398|NCT01081769|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The Short Form-36 Health Survey (SF-36) is a measure of Participant-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary. Each summary scale score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72399|NCT01081769|Secondary|Changes From Baseline in Personal and Social Performance (PSP) Total Score|The Personal and Social Performance (PSP) scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|baseline (day 1 of core phase), month 1, 3, 6, 9, 12, 15, 18, 21 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72788|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Full Range|Median
72401|NCT01081769|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global clinical assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate higher impression of illness severity."|Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72402|NCT01081769|Secondary|Change From Baseline in PANSS Marder Factor Scores|Change from baseline in schizophrenia symptoms were assessed through the following PANSS factor scores as described by Marder: (1) positive symptoms (range 8-56): sum of delusions, hallucinatory behavior, grandiosity, suspiciousness, stereotyped thinking, somatic concern, unusual thought content, lack of judgment and insight; (2) negative symptoms (range 7-49): sum of blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance; (3) disorganized thoughts (range 7-49): sum of conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, poor attention, disturbance of volition, and preoccupation; (4) uncontrolled hostility/excitement (range 4-28): sum of excitement, hostility, uncooperativeness and poor impulse control; (5) anxiety/depression (range 4-28): sum of anxiety, guilt feelings, tension, and depression. Higher scores indicate higher severity of symptoms|Baseline (day 1 of core phase), day 8, month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72403|NCT01081769|Secondary|Change From Baseline in PANSS Subscale Score|Change from baseline in positive symptom, negative symptom and general psychopathology subscales of the PANSS scale. The PANSS scale is designed to assess symptoms of schizophrenia by means of the 30-items. The PANSS scale provides subscores for 3 subscales, that is, the positive symptoms subscale (7 items, range 7-49), the negative symptoms subscale (7 items, range 7-49), and the general psychopathology subscale (16 items, range 16-112). Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). Higher scores indicate higher severity of schizophrenia symptoms.|Baseline (day 1 of core phase), day 8, month 12, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72404|NCT01081769|Secondary|Change From Baseline in PANSS Total Score|Change from baseline in the PANSS: The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||units on a scale||Standard Deviation|Mean
72405|NCT01081769|Secondary|Percentage of Treatment Responders|The proportion of patients achieving a treatment response, defined as a ≥30% decrease (i.e., improvement) in Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint. The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate increased severity of schizophrenia symptoms.|from baseline (day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||percentage of participants||95% Confidence Interval|Number
72406|NCT01081769|Primary|Time to First Relapse Event|Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator’s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (“much worse”) or 7 (“very much worse”) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.|from baseline (Day 1 of core phase) up to maximally 24 months.|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment||days||Standard Error|Mean
72407|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized|The mean (average) number of days hospitalized per participant for those hospitalized during the study.|Baseline to Month 24 Visit|Based on participant hospitalizations during the study where the length of hospitalization was known (82 participants total).||days||Standard Deviation|Mean
72408|NCT01081665|Secondary|To Estimate the Incidence of (S)AEs/(S)ADRs|The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||participants|||Number
72409|NCT01081665|Secondary|The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product|The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||Participants|||Number
72410|NCT01081665|Secondary|The Incidence of Clinically Significant Hyperphosphatemia|The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||Participants|||Number
72411|NCT01081665|Secondary|The Incidence of Clinically Significant Hypercalcemia|The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||Participants|||Number
72412|NCT01081665|Secondary|The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)|Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.|Baseline to Month 24 Visit|Analysis based on the evaluable population, defined as participants with baseline and at least 2 post-baseline parathormone measurements at the 24-month post-treatment follow-up visit.||percentage of participants|||Number
72413|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations|The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.|Baseline to Month 24 Visit|Analysis included all enrolled participants.||participants|||Number
72414|NCT01081626|Secondary|Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire|Ease of use of Gonal-f® pen was assessed through a questionnaire consisting of 23 questions and the number of participants who responded to the questionnaire was recorded.|On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
72415|NCT01081626|Secondary|Total Follicle Stimulating Hormone (FSH) Dose||End of stimulation cycle (less than or equal to [<=] 35 days|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||IU||Standard Deviation|Mean
72416|NCT01081626|Secondary|Duration of Follicle Stimulating Hormone (FSH)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||Days||Standard Deviation|Mean
72417|NCT01081626|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||participants|||Number
72418|NCT01081626|Secondary|Number of Participants With Cancelled Cycles|Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.|End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
72419|NCT01081626|Secondary|Number of Participants Who Received Human Chorionic Gonadotropin (hCG)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
72420|NCT01081626|Secondary|Number of Participants With Injection Tolerability|Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||participants|||Number
72421|NCT01081626|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.||participants|||Number
72422|NCT01081626|Secondary|Number of Participants With Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit.||participants|||Number
72423|NCT01081626|Secondary|Number of Participants With Multi-follicular Development|Multi-follicular development was defined as the development of more than 3 follicles >= 15 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||participants|||Number
72424|NCT01081626|Primary|Percentage of Participants With a Mono-follicular Development|Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The Intention-To-Treat (ITT) population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.||percentage of participants|||Number
72425|NCT01081301|Secondary|SF12: Physical Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
72426|NCT01081301|Secondary|Non-Death Revised Grief Experience Inventory|The Non-Death Revised Grief Experience Inventory measures grief that is not associated with the death of a person. It is a 22-item scale measuring four domains (existential concerns, depression, tension and guilt, and physical distress) of the grief experience. Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
72427|NCT01081301|Secondary|General Self-Efficacy Score (GSES)|The scale consists of 10 items with responses from 1-4. The higher the Scores on the General Self Efficacy Scale (which has a range from 10 - 40), indicate higher participant feelings of self-efficacy. The General Self Efficacy Scale was chosen as a measure for this study because it has been found to be a reliable and valid measure in many populations.|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
72428|NCT01081301|Secondary|SF12 Mental Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|baseline, 1 and 2 wks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
72429|NCT01081301|Primary|Herth Hope Index|The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.|Baseline, 1week, 2 weeks, 3, 6 and 12 months|||units on a scale||Standard Deviation|Mean
72430|NCT01081249|Secondary|Subjective Ratings of Anxiety and Trust of the Therapist|Patient will fill out ratings of subjective anxiety (STAI), mood and energy (PANAS), and trust (Likert scale) in the therapist before and after the session.|measured before drug, immediately before session, and after the session||||||
72431|NCT01081249|Secondary|Heart Rate Variability (HRV)|HRV will be measured before, during and after the therapy session.|continuously monitored from time before drug delivery to 20 minutes after session||||||
72432|NCT01081249|Secondary|Salivary Cortisol|Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.|before drug, before session, and 20 minutes after session||||||
72433|NCT01081249|Primary|Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug|Videotapes of 2 therapy session (PBO/OT) were reviewed by blinded raters to determine differences in two treatments. There were nine aspects analyzed using the Ethological Coding System for Interviews: eye contact, affiliation, submission, prosocial, flight, assertion, displacement, relaxation, and gesture.|videotapes of session were reviewed and scored 1-3 months after the patient completes the study|||Number of behaviors exhibited||Standard Deviation|Mean
72434|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Open-Label Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|13 weeks|Open-label Safety Population defined as all subjects who took at least 1 dose of any investigational product during the study.||participants|||Number
72435|NCT01081145|Secondary|HUI 2/3 Scores During the Open-Label Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|13 weeks|Open-label FAS||units on a scale||Standard Deviation|Mean
72436|NCT01081145|Secondary|Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Open-label FAS||units on a scale||Standard Deviation|Mean
72789|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Full Range|Median
72437|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|13 weeks|Open-label FAS||percentage of participants|||Number
72438|NCT01081145|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|13 weeks|Open-label FAS||percentage of participants|||Number
72439|NCT01081145|Secondary|Percentage of Responders in the Open-Label Phase - LOCF|Response is defined as a percentage decrease (improvement) from Baseline in the ADHD-RS-IV total score of >=30% and a CGI-S score of 1 or 2.|13 weeks|Open-label FAS||percentage of participants|||Number
72440|NCT01081145|Secondary|Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 13 weeks|Open-label Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of any investigational product during the study. The Subjects from Site 801 were excluded from the Open-label FAS.||units on a scale||Standard Deviation|Mean
72441|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|26 weeks|Randomized Safety Population defined as all subjects who were randomized and who took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase.||participants|||Number
72442|NCT01081145|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|26 weeks|Randomized FAS||units on a scale||Standard Deviation|Mean
72443|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 26|Randomized FAS||units on a scale||Standard Error|Least Squares Mean
72444|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|26 weeks|Randomized FAS||percentage of subjects|||Number
72445|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and week 26|Randomized FAS||units on a scale||Standard Error|Least Squares Mean
72446|NCT01081145|Secondary|Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized FAS||Days||95% Confidence Interval|Median
72447|NCT01081145|Primary|Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized Full Analysis Set (FAS) defined as all subjects who were randomized and took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. Subjects from Site 801 were excluded from the Randomized FAS.||percentage of treatment failures||95% Confidence Interval|Number
72448|NCT01081132|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||participants|||Number
72449|NCT01081132|Secondary|Structure Side-Effect Questionnaire (SSEQ)|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking ‘yes’ or ‘no’ on the checklist for each of the events listed.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||participants|||Number
72945|NCT01077713|Secondary|Overall Survival (OS)|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization to death or end of the study (up to 53 months)|ITT set||months||95% Confidence Interval|Median
72450|NCT01081132|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Deviation|Mean
72451|NCT01081132|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 item questionnaire scored on a scale from 0 (never) to 4 (always/very often). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline through week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72452|NCT01081132|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13|Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Lower scores reflect better functioning.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72453|NCT01081132|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|weeks 1 through 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of subjects|||Number
72454|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72455|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72456|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72457|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72458|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72459|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Global Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72460|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72461|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72462|NCT01081132|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||units on a scale||Standard Error|Least Squares Mean
72566|NCT01079988|Secondary|Patient's Global Psoriasis Assessment (PGPA)|"The PGPA consisted of a single self-explanatory item:~On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now.~Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis)."|12 weeks|One patient withdrew||PGPA score||Standard Deviation|Mean
72463|NCT01081132|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|Baseline through week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.||percentage of subjects|||Number
72464|NCT01081132|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline through week 13|The Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. A mixed model repeated measures (MMRM) was used to analyze the observed change from the Baseline Visit scores at all post-baseline, pre-taper, on-treatment visits.||units on a scale||Standard Error|Least Squares Mean
72465|NCT01081041|Secondary|Area Under the Concentration Curve (AUC) of Cetuximab at Steady State|A total of 4 samples were collected during combination therapy, from the first dose of 250 mg/m^2 cetuximab in Cycle 1 (Day 1) through the final dose in Cycle 3 (Week 3) and used to report AUC of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (250 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.||micrograms*hours/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
72466|NCT01081041|Secondary|Cmax of Cetuximab at Steady State|A total of 4 samples were collected at various times during combination therapy, from the third dose of 250 mg/m^2 cetuximab in Cycle 1 (Week 3) through the final dose in Cycle 3 (Week 3) and used to report Cmax of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
72467|NCT01081041|Secondary|Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing|The Cmax of cetuximab following 400 mg/m² cetuximab dosing during Part 2 of the study is reported. As specified in the protocol, pharmacokinetics (PK) samples were not collected during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy.|Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m²) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy..||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
72468|NCT01081041|Secondary|Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)|Response was defined using RECIST, v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
72469|NCT01081041|Secondary|Number of Participants With Anti-Cetuximab Antibodies||Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion).|All participants who received at least one dose of drug and had evaluable data for antibodies. These analyses were not planned to be reported on their own because Immunogenicity data was pooled from three studies.||participants|||Number
72470|NCT01081041|Secondary|Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version [v]1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants with a confirmed CR or PR=(number of participants whose best overall response was CR or PR)/(number of participants treated)*100.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
72471|NCT01081041|Secondary|Progression-Free Survival (PFS)|PFS was defined as duration from the date of randomization to the first date of objective progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had objective PD as of the 23 October 2014 data cutoff date for the analysis, PFS was censored at the date of the participant’s last complete tumor assessment prior to that cutoff date. In addition, any participant in Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)|All participants who received at least one dose of study drug. 7 participants were censored in Safety Lead-In ,12 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).||Months||95% Confidence Interval|Median
72472|NCT01081041|Secondary|Overall Survival (OS)|OS was defined as duration from the date of randomization to the date of death from any cause. For each participant not known to have died as of the 23 October 2014 data cutoff date for the analysis, OS was censored at the date last known to be alive. In addition, any participants on Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)|All participants who received at least on dose of study drug. 4 participants were censored in Safety Lead-In, 17 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).||Months||95% Confidence Interval|Median
72473|NCT01081041|Primary|Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013|January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized.||participants|||Number
72474|NCT01081041|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013|September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized. Data is confounded for 9 participants in BI-manufactured cetuximab treatment arm who switched to US commercial cetuximab.||participants|||Number
72475|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
72476|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
72477|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
72478|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
72479|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score|FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
72946|NCT01077713|Secondary|Percentage of Participants Who Died||From randomization to death or end of the study (up to 53 months)|ITT set||percentage of participants|||Number
72480|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score|FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15.|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint||Units on a scale||Standard Error|Least Squares Mean
72481|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
72482|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
72483|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
72484|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)||Units on a scale||Standard Error|Least Squares Mean
72485|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
72486|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
72487|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
72567|NCT01079988|Primary|Physician's Global Assessment (PGA) of Change Over Time (Good or Better)|"The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline:~Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%"|12 weeks|||participants|||Number
72488|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation (or last observation after baseline))|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
72489|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
72490|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.||Units on a scale||Standard Error|Least Squares Mean
72491|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 6||Percentage of participants|||Number
72492|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 3|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 3||Percentage of participants|||Number
72493|NCT01080807|Secondary|Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
72494|NCT01080807|Secondary|Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 3|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
72495|NCT01080807|Secondary|Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
72496|NCT01080807|Secondary|Change From Baseline to Week 6 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 6|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
72497|NCT01080807|Secondary|Change From Baseline to Week 3 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 3|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
72498|NCT01080807|Secondary|Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group.|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.||Units on a scale||Standard Error|Least Squares Mean
72499|NCT01080807|Primary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
72500|NCT01080768|Primary|Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method|AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.|Baseline, 4 weeks|The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.||mL||Standard Error|Least Squares Mean
72501|NCT01080625|Primary|Occurrence of Postreperfusion Syndrome (PRS)|the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group|immediately after reperfusion|Initial assessment for eligibility: n=128 32 patients who did not meet the criteria were excluded 96 patients were randomized Contorol (32 patients) --> 1 patient was excluded because of portalvein rupture Epinephrine (33 patients) --> data recording error (1 patient) practice error (1 patient) Phenylephrine group (31 patient)||percentage of participants|||Number
72502|NCT01080391|Secondary|QLQ-C30 Global Health Status/Quality of Life Scores|European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Module QLQ-C30 (QLQ-C30 GHS/QoL) is a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. The minimal important difference for between group differences is 5 points.|Day 1 of Cycles 3, 6, 12, 18|ITT analysis set comprised of all randomized participants.||scores on a scale||Standard Deviation|Mean
72503|NCT01080391|Secondary|Duration of Disease Control|Duration of disease control (DDC) was calculated for participants who achieved disease control.DDC was defined as the time in months from randomization to the earlier of documented Progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.|The Intent to treat (ITT) population with participantants who achieved disease control.||months||95% Confidence Interval|Median
72504|NCT01080391|Secondary|Duration of Response|Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented Progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.|The Intent to treat (ITT) population with participantant with participants who achieved a best overall response of PR or better.||months||95% Confidence Interval|Median
72505|NCT01080391|Secondary|Disease Control|Number of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants||participants|||Number
72506|NCT01080391|Secondary|Overall Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the data cutoff date of 16 June 2014.Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants||participants|||Number
72507|NCT01080391|Secondary|Overall Survival|Time elapsed between the randomization date and the date of death. Participants who were still alive were censored at the date when the subject was last known to be alive or the data cutoff date, whichever occurs earlier. The median and all but one of the 95% confidence limits were not estimable. Instead, the number of participants who died or were censored are reported.|From randomization through the data cutoff date of 16 June 2014. Median follow up time was approximiately 32 months.|ITT analysis set comprised of all randomized participants||participants|||Number
72947|NCT01077713|Secondary|Percentage of Participants Alive at 12 Months After Randomization||1 year|ITT set||percentage of participants||95% Confidence Interval|Number
72508|NCT01080391|Primary|Progression-free Survival (PFS)|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants||months||95% Confidence Interval|Median
72509|NCT01080326|Primary|Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair|"At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage.~Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated."|2 days post-operation|||participants|||Number
72510|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|"To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline."|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population||scores on a scale||95% Confidence Interval|Least Squares Mean
72511|NCT01080300|Secondary|Evaluate Safety of G-ER|Evaluate safety of G-ER,change from average daily frequency & severity score of HFs from baseline to end point(wk 24),assess sleep interference, depression,suicidal ideation, quality of life, patient and investigator global impression of change|6mt treatment, 1mt f/u||||||
72512|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population||hot flashes||95% Confidence Interval|Least Squares Mean
72513|NCT01080261|Secondary|Clinical Procedural Success (Percentage of Participants)|Expressed as percentage of participants in whom mean lesion diameter stenosis was <30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death.|While participant is in the hospital|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72514|NCT01080261|Secondary|Technical Success (Percentage of Stents)|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|At time of index procedure|Analysis was intention to treat||percentage of stents|Participants||Number
72515|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days - 9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72516|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|0-30 Days (Early)|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72517|NCT01080261|Secondary|Target Lesion Failure (TLF) (Percentage of Participants With an Event)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72545|NCT01080131|Secondary|Physician’s Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
72518|NCT01080261|Secondary|Target Vessel Failure (TVF) (Percentage of Participants With an Event)|Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72519|NCT01080261|Secondary|Target Lesion Revascularization (Percentage of Participants With an Event)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR.|9 months|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.||percentage of participants|||Number
72520|NCT01080261|Secondary|Target Vessel Revascularization (Percentage of Participants With an Event)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72521|NCT01080261|Secondary|Cardiac Death (Percentage of Participants With an Event)|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72522|NCT01080261|Secondary|All-cause Death (Percentage of Participants With an Event)|Participants who died from any cause|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72523|NCT01080261|Secondary|Myocardial Infarction (MI) (Percentage of Participants With an Event)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin <ULN); if no new Q-waves total CK or troponin >3× ULN (baseline troponin <ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× ULN|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72524|NCT01080261|Primary|Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)|A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
72525|NCT01080248|Secondary|Overall Survival||1 year|||participants|||Number
72526|NCT01080248|Secondary|Median Survival||Length of follow-up was 35 weeks|||weeks||Full Range|Median
72527|NCT01080248|Secondary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time to progression.~Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment.||weeks|||Number
72528|NCT01080248|Primary|Response Rate by RECIST Criteria.|"Response rate = complete response + partial response per RECIST~Complete response - disappearance of all target and non-target lesions.~Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter"|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment. The remaining participant had progressive disease per RECIST while on treatment.||percentage of participants|||Number
72529|NCT01080209|Secondary|Number of Patients With Vision Loss in the Study Eye|Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.|Baseline of Parent Study, Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study||Patients|||Number
72530|NCT01080209|Primary|Number of Patients With No Visible Implants in the Study Eye|Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.|Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study||Patients|||Number
72580|NCT01079949|Secondary|Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||pg/mL||Standard Deviation|Mean
72531|NCT01080131|Secondary|Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab|"Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||mg/L||Standard Deviation|Mean
72532|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab|"High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||mg/L||Standard Deviation|Mean
72533|NCT01080131|Secondary|Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
72534|NCT01080131|Secondary|Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for swelling on the following 4-point scale:~no swelling;~palpable;~visible;~bulging beyond the joint margins.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
72535|NCT01080131|Secondary|Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for tenderness on the following 4-point scale:~no pain;~participant states that there is pain;~participant states there is pain and winces;~participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
72536|NCT01080131|Secondary|Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|"The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.~The physician completed the physician’s global assessment of response to treatment without viewing any of the patient’s assessments.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
72554|NCT01080131|Secondary|Time to the First New Gout Flare During 24 Weeks|"Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|From randomization to the end of the first extension period (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||days||95% Confidence Interval|Median
72537|NCT01080131|Secondary|Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
72538|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab|"Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||percentage of participants|||Number
72539|NCT01080131|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Participants met the definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.~Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||flares per patient per year||95% Confidence Interval|Mean
72540|NCT01080131|Secondary|Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before flare has resolved completely."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||days||95% Confidence Interval|Median
72541|NCT01080131|Secondary|Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme|For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.|From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.||Percentage of participants|||Number
72542|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
72543|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|"For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. N indicates the number of participants with available data in each analysis."||mg/L||95% Confidence Interval|Least Squares Mean
72544|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.||participants|||Number
72546|NCT01080131|Secondary|Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
72547|NCT01080131|Secondary|Patient’s Global Assessment of Response to Treatment|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.||percentage of participants|||Number
72548|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks|This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During 24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment||Participants|||Number
72549|NCT01080131|Secondary|Physician’s Global Assessment of Response to Treatment|The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s own assessments (pain intensity and patient’s global assessment of response to treatment).|72 hours post-dose and 24-weeks post-dose.|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available for this endpoint at the specified time point.||percentage of participants|||Number
72550|NCT01080131|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.||mg||Standard Deviation|Mean
72551|NCT01080131|Secondary|Percentage of Participants Who Took Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.||percentage of participants|||Number
72552|NCT01080131|Secondary|Time to First Intake of Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.~Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks)."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.||hours||95% Confidence Interval|Median
72553|NCT01080131|Secondary|Mean Number of New Gout Flares Per Patient During 24 Weeks|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint(at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|24 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||new flares per patient||Standard Deviation|Mean
72555|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)|Patient’s assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.||mm||Standard Error|Least Squares Mean
72556|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||mm||Standard Error|Least Squares Mean
72557|NCT01080131|Secondary|Pharmacokinetic Concentrations|Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.|12 weeks post-dose|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||µg/mL||Standard Deviation|Mean
72558|NCT01080131|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||mm||Standard Error|Least Squares Mean
72559|NCT01080131|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study|The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.|Baseline to Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||percentage of participants|||Number
72560|NCT01080131|Secondary|SF 36 Physical Function Score at Week 12|SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
72561|NCT01080131|Secondary|Time to Complete Resolution of Pain; Survival Analysis|Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS): All patients that received study drug.||hours||95% Confidence Interval|Number
72562|NCT01080131|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)|Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||hours||95% Confidence Interval|Median
72563|NCT01080131|Primary|Time to First New Flare: Survival Analysis During the 12 Weeks of Study|Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.|Baseline to 12 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Days||95% Confidence Interval|Median
72564|NCT01080118|Secondary|Time to Intubation|Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.||seconds||95% Confidence Interval|Mean
72565|NCT01080118|Primary|Successful Endotracheal Intubation|A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.||% successful|||Number
72568|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|Per protocol (PP) population included those participants for whom primary and secondary efficacy endpoints were all measured, and who did not meet the withdrawal criteria and showed 75 percent of medication compliance.||mmHg||Standard Deviation|Mean
72569|NCT01079962|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 14 (follow-up visit)|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||Participants|||Number
72570|NCT01079962|Secondary|Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12|The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||mmHg||Standard Deviation|Mean
72571|NCT01079962|Secondary|Change From Baseline in Blood Glucose Levels at Week 12|The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
72572|NCT01079962|Secondary|Change From Baseline in Lipid Levels at Week 12|The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||Milligram/decilitre (mg/dL)||Standard Deviation|Mean
72573|NCT01079962|Secondary|Change From Baseline in Aortic Pulse Pressure (APP) at Week 4|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline.|Baseline and Week 4|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.||mmHg||Standard Deviation|Mean
72574|NCT01079962|Secondary|Change From Baseline in Heart Rate at Week 4 and Week 12|The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Beats per minute (bpm)||Standard Deviation|Mean
72575|NCT01079962|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12|Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Meters per second (m/s)||Standard Deviation|Mean
72576|NCT01079962|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12|Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Ratio||Standard Deviation|Mean
72577|NCT01079962|Secondary|Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12|The change in aortic BP (aortic systolic blood pressure [SBP], aortic diastolic blood pressure [DBP] and aortic mean blood pressure [BP]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||mmHg||Standard Deviation|Mean
72578|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."||Millimeter of mercury (mmHg)||Standard Deviation|Mean
72579|NCT01079949|Secondary|Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
92758|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)||Baseline up to Month 7|||percentage of participants|||Number
72581|NCT01079949|Secondary|Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||milli international unit (mIU)/mL||Standard Deviation|Mean
72582|NCT01079949|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication.N (number of participants analyzed) signifies those participants with plasma E2 levels at r-hCG day."||picogram/milliter (pg/mL)||Standard Deviation|Mean
72583|NCT01079949|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||IU||Standard Deviation|Mean
72584|NCT01079949|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first r-hFSH injection (S1) until day on which r-hCG was administered (r-hCG day).|Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||days||Standard Deviation|Mean
72585|NCT01079949|Secondary|Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
72586|NCT01079949|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
72587|NCT01079949|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]})|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||percent sacs per embryo||Standard Deviation|Mean
72588|NCT01079949|Secondary|Number and Quality of Embryos|Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who continued with follicular development."||embryos|||Number
72589|NCT01079949|Secondary|Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN|Oocytes were fertilized using ICSI technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||oocytes|||Number
72590|NCT01079949|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||2PN oocytes|||Number
72591|NCT01079949|Secondary|Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day|Endometrial thickness measurement was performed on the day of r-hCG administration.|r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."||mm||Standard Deviation|Mean
72592|NCT01079949|Secondary|Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||follicles||Standard Deviation|Mean
72593|NCT01079949|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
72594|NCT01079949|Primary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.||cycles|||Number
72595|NCT01079949|Primary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
72596|NCT01079949|Primary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||mature oocytes|||Number
72597|NCT01079949|Primary|Number of Oocytes Retrieved|Number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."||oocytes||Standard Deviation|Mean
72598|NCT01079936|Primary|Participants With Grade 3 =/> Adverse Events|Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.|Day 90 after stem cell transplant|||participants|||Number
72599|NCT01079936|Primary|Number of Participants With Day 30 DLT (Overall Study, Phase I/Phase II)|Dose limiting toxicity (DLT) was defined as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT.|Day 30 following transplant|||participants|||Number
72600|NCT01079936|Primary|Number of Participants With Response (CR at Day 90)|Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with <5% plasma cells. There should be < 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.|Day 90 after stem cell transplant|||participants|||Number
72601|NCT01079936|Primary|Maximum Tolerated Dose (MTD) of Lenalidomide|There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.|Assessed at 21-28 Day Cycle|Of the 16 participants in Phase I, two participants were not eligible for study due to first remission status, and two were eligible but did not receive stem cell transplant due to other issues.||mg/day|||Number
72602|NCT01079832|Secondary|Clinical Response Rate|Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).|at 6 months from study entry|Intent to treat||percentage of participants||95% Confidence Interval|Number
72603|NCT01079832|Secondary|Quality of Life||After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.|Participant surveys were unreliably returned to investigators, making this analysis not meaningful.|||||
72604|NCT01079832|Secondary|Median Overall Survival|Length of time patients survived at study end.|24 months|Intent to treat||months||95% Confidence Interval|Median
72605|NCT01079832|Secondary|Disease-free Survival|Median disease free survival|completion of study at 24 months|Intent to treat||months||95% Confidence Interval|Median
72606|NCT01079832|Primary|Acute Toxicity Rate|The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.|at 6 months after treatment|Intent to treat||percentage of participants|||Number
72607|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; ULN=upper limit of normal; LLN=lower limit of normal. ALT, AST (*ULN): Grade 1=1.25-2; Grade 2=2.6-5; Grade 3=5.1-10; Grade 4= >10. Bilirubin (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2.5; Grade 3=2.6-5; Grade 4= >5. Albumin (g/dL): Grade 1=3- <LLN; Grade 2=2-2.9; Grade 3= <2. Lipase (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-3; Grade 3=3.1-5; Grade 4= >5. BUN/urea (*ULN): Grade 1=1.25-<2.6; Grade 2=2.6-<5.1; Grade 3=5.1-10; Grade 4= >10. Chloride, high (mEq/L): Grade 1=113-<117; Grade 2=117-<121; Grade 3=121-125; Grade 4= >125. Potassium, low (mEq/L): Grade 1=3-3.4; Grade 2=2.5-<3; Grade 3=2-<2.5; Grade 4=<2. Potassium, high (mEq/L): : Grade 1= 5.6-<6.1; Grade 2=6.1-<6.6; Grade 3=6.6-7; Grade 4= >7. Sodium, high (mEq/L): Grade 1=146<151; Grade 2=151-<155; Grade 3=155-<160; Grade 4= >=160.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study medication; n=number of participants with laboratory results available||Participants|||Number
72619|NCT01079234|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 6 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
79716|NCT01003184|Secondary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||Percentage of total hemoglobin||Standard Error|Least Squares Mean
72608|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. INR=international normalization ratio of prothrombin time; ULN=upper limit of normal. Hemoglobin (g/dL): Grade 1=10-10.9; Grade 2=9-9.9; Grade 3=7-8.9; Grade 4= <7. Platelets (/mm^3): Grade 1=100,000-124,999; Grade 2=50,000-99,999; Grade 3=25,000-49,999; Grade 4= <25,000. INR (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2; Grade 3=2.1-3; Grade 4= >3. WBC (/mm^3): Grade 1=2000-2500; Grade 2=1500-1999; Grade 3=1000-1499; Grade 4= <1000. Neutrophils (/mm^3): Grade 1=1000-1300; Grade 2=750-999; Grade 3=500-749; Grade 4= <500.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study medication; n=number of participants with laboratory results available||Participants|||Number
72609|NCT01079806|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. ALT=alanine aminotransferase.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study drug||Participants|||Number
72610|NCT01079806|Secondary|Percentage of Participants With Hepatitis B e (HBe) Seroconversion at Week 48|HBe seroconversion=undetectable HBe antigen and detectable anti-HBe antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
72611|NCT01079806|Secondary|Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
72612|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48|LOQ=29 IU/mL. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
72613|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
72614|NCT01079806|Primary|Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48|Suppression=HBV DNA<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)||Percentage of participants|||Number
72615|NCT01079299|Primary|Median Time to Wound Closure at 9 Months|Median number of days for complete healing in each treatment group|9 months|||median number of days for complete heali||Standard Error|Median
72616|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||Episodes/100 years of patient exposure|||Number
72617|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||Episodes/100 years of patient exposure|||Number
72618|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). FPG baseline values were missing for 6 subjects. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||mmol/L||Standard Deviation|Mean
79740|NCT01002482|Secondary|Severe Hypoglycemia|Number of patients with severe biological hypoglycemia (defined as blood glucose of 40 mg per deciliter or less)regardless of clinical signs|Date of discharge from the ICU|||participants|||Number
72620|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
72621|NCT01079234|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
72622|NCT01079195|Secondary|Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity|The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity.|6 months|This analysis used the safety analysis population, which included any participant who took at least one dose of Tarka and had at least one follow-up visit.||Events|||Number
72623|NCT01079195|Secondary|Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka.|The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized.|6 months|2122 participants were excluded from the analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).||Percentage of participants|||Number
72624|NCT01079195|Primary|Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End|"Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point end of study."|Baseline to 6 months/study end|2122 participants were excluded from this analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).||mmHg||Standard Deviation|Mean
72625|NCT01079182|Secondary|Mean Equivalent Dose of Prednisolone|The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||mg/day||Standard Deviation|Mean
72626|NCT01079182|Secondary|Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents|Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72627|NCT01079182|Secondary|Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72628|NCT01079182|Secondary|Percentage of Participants on Adalimumab Monotherapy||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72629|NCT01079182|Secondary|Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Days||Standard Deviation|Mean
72630|NCT01079182|Secondary|Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72631|NCT01079182|Secondary|Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Days||Standard Deviation|Mean
72632|NCT01079182|Secondary|Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72633|NCT01079182|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks|The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72677|NCT01078805|Secondary|Treatment Adherence|Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.||days||Standard Deviation|Mean
79741|NCT01002482|Secondary|Time Spent in Blood Glucose Target||Day of discharge from the ICU||||||
72634|NCT01079182|Secondary|Percentage of Participants Achieving ASAS Partial Remission Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72635|NCT01079182|Primary|Number of Participants With Drug-Related Adverse Events (AEs)|An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.|From signing of informed consent up to 24 months|Safety analysis set: Participants who received at least one dose of adalimumab.||Participants|||Number
72636|NCT01079182|Secondary|Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.|At 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72637|NCT01079182|Secondary|Mean Duration of Morning Stiffness|Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||minutes||Standard Deviation|Mean
72638|NCT01079182|Secondary|Percentage of Participants With Morning Stiffness|Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72639|NCT01079182|Secondary|Mean Participant Pain Score|Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Score on scale||Standard Deviation|Mean
72640|NCT01079182|Secondary|Mean Participant Fatigue Score|Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Score on scale||Standard Deviation|Mean
72641|NCT01079182|Secondary|Mean Global Assessment of Disease Activity Score|Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Score on scale||Standard Deviation|Mean
72642|NCT01079182|Secondary|Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score|The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||BAS-G score||Standard Deviation|Mean
72643|NCT01079182|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||mg/L||Standard Deviation|Mean
72644|NCT01079182|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||mm/hour||Standard Deviation|Mean
72645|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||BASFI score||Standard Deviation|Mean
72678|NCT01078805|Secondary|Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.||percentage change of pain score||Standard Error|Mean
72646|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||BASDAI score||Standard Deviation|Mean
72647|NCT01079182|Secondary|Percentage of Participants With Extraspinal Manifestations|Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Percentage of participants|||Number
72648|NCT01079182|Secondary|Mean Number of Involved Peripheral Joints|Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.||Joints||Standard Deviation|Mean
72649|NCT01079143|Secondary|Incidence (Number) of Participants With Graft Losses|If a participant underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
72650|NCT01079143|Secondary|Incidence (Number) of BPAR|A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Number of participants|||Number
72651|NCT01079143|Secondary|Severity of BPAR|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.~Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.~Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
72652|NCT01079143|Secondary|Type of Biopsy Proven Acute Rejection (BPAR)|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.~Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.~Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
72653|NCT01079143|Secondary|Treatment Failures|A treatment failure is defined as biopsy proven acute rejection (BPAR), a graft loss, a death or a loss to follow up. It was assessed between randomization and 6 and 12 months post-transplantation.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Number of Participants|||Number
72654|NCT01079143|Secondary|Change in Urine Protein/Creatinine Ratio (Without Imputation)|One of the factors associated with EMT progression between M3 and M12 according to univariate analysis (ITT biopsies M3 & M12).|Month 3 (baseline), Month 12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||mg/mmol||Standard Deviation|Mean
72655|NCT01079143|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR) at M12 From Baseline (M3) - ANCOVA Model|The average patient renal function was evaluated on the basis of eGFR was calculated according to the abbreviated MDRD formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).|Baseline (M3), M12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||mL/min/1.73m²||Standard Deviation|Mean
72656|NCT01079143|Secondary|Change From Baseline (M3) in Estimated Glomerular Filtration Rate (eGFR)|"eGFR was calculated according to the abbreviated Modification of Diet in Renal Disease (MDRD) Formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).~LOCF = Last observation carried forward"|M3 (baseline) to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||mL/min/1.73m^2||Standard Error|Least Squares Mean
72679|NCT01078805|Secondary|Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.||percentage change of pain score||Standard Error|Mean
92759|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)||Baseline up to Month 7|||percentage of participants|||Number
72657|NCT01079143|Secondary|Incidence (Number) of Subclinical Rejections and Borderline Lesions|"Incidence of subclinical rejections and borderline lesions with regards to histological evidence of rejection with clinical findings.~Subclinical rejections: rejection without clinical symptoms which is diagnosed by chance when a graft biopsy is performed.~Clinically suspected BPAR: rejection suspected because of the presence of clinical symptoms (fever, pain, increase of creatinine) and then confirmed by the graft biopsy.~Borderline lesions: suspicious for acute T-cell mediated rejection. This category is used when no intimal arteritis is present, but there are foci of tubulitis with minor interstitial infiltration or interstitial infiltration with mild tubulitis."|M3|ITT population: All patients randomized in the study who received at least one dose of the study treatment.||Participants|||Number
72658|NCT01079143|Secondary|Change in EMT Score|"Change (M12 - M3) in EMT Score. Progression in EMT score is defined as an increase by >=1 of EMT score from M3 to M12.~EMT score 0 (the best): <1 EMT score 1 (the better) : 1-10% of tubular atrophy EMT score 2 : 10-25% of tubular atrophy EMT score 3 : 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||scores on a scale||Standard Deviation|Mean
72659|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Score|"Incidence and severity of EMT score. The intensity of EMT markers expression present and detectable in the renal graft at an early stage following transplantation is known as EMT score.~EMT score 0 (the best): <1 EMT score 1 (the better): 1-10% of tubular atrophy EMT score 2: 10-25% of tubular atrophy EMT score 3: 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||participants|||Number
72660|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Status|Incidence and severity of EMT status. EMT status was determined centrally using the graft biopsy taken at 3 months. The result was quickly obtained (within 7 to 15 days) and sent to the company in charge of randomization in order to allocate each patient to a treatment group and to provide the investigator with this information without confirming EMT status.|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Participants|||Number
72661|NCT01079143|Secondary|Number of Participants With Progression of Renal Fibrosis Using Numerical Quantification|Comparisons according to epithelial-mesenchymal transition (EMT) profile and immunosuppressive treatment|M3 to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Participants|||Number
72662|NCT01079143|Secondary|Change in Percentage of Interstitial Fibrosis (IF) by Numerical Quantification|Percentage of IF measured by numerical quantification. The IF percentage was transposed in grade according to the following rule: grade 0 for an IF % ≤5%, grade I for an IF % ranging from >5% to < 25%, grade II for an IF % ranging from 25 to 50%, grade III for an IF % >50%. Interstitial graft fibrosis has been identified as the primary cause of graft loss following death with a functional graft [3-5].|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Percentage of IF||Standard Deviation|Mean
72663|NCT01079143|Secondary|Risk Factors of IF/TA Progression|"Composite factors regarding fibrosis progression at 12 months using a logistic regression model; the parameters initially considered concerned the demographic characteristics of both recipient and donor, transplantation characteristics, hypertension, diabetes, study treatments, immunosuppression, EMT, IF/TA, function at M3, the onset of acute rejection, the presence of anti-donor antibodies at M12, infections and BK virus viremia.~Arteriolar hyaline thickening is thickening of the walls of arterioles by the deposition of homogeneous pink hyaline material.~BPAR is biopsy proven acute rejection. TEM progression is the increase ≥ 1 of TEM score between Month 3 and Month 12"|M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Participants|||Number
72664|NCT01079143|Secondary|Change in Interstitial Fibrosis/Tabular Atrophy (IF/TA) Grade|Difference (M12 - M3) in IF/TA grade. IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Number of Participants|||Number
72665|NCT01079143|Secondary|Interstitial Fibrosis/Tabular Atrophy (IF/TA)|Incidence and severity of IF/TA according to 2005/2007 Banff classification system grades (grades l to lll). IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.||Number of participants|||Number
72680|NCT01078805|Secondary|Percentage of Participants With Clinical Vertebral Fractures|Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.||Percentage of participants|||Number
72666|NCT01079143|Primary|Number of Participants With Progression of Renal Graft Fibrosis (Primary Comparison - ITT Population|"Progression of Interstitial Fibrosis/Tabular Atrophy (IF/TA) is the percentage (%) of participants with an increase >= 1 in IF/TA grade according to Banff (2005 - 2007)according to Epithelial-mesenchymal transition (EMT) profile and by treatment groups.~Grade I (the better): mild interstitial fibrosis and tubular atrophy (<25% of cortical area) Grade II : moderate interstitial fibrosis and tubular atrophy (26-50% of cortical area) Grade III (the worse) : severe interstitial fibrosis and tubular atrophy (>50% of cortical area)"|Month 3 (M3) and Month 12 (M12) post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12. The primary comparison concerned only the Certican and the Neoral EMT+ groups.||Participants|||Number
72667|NCT01079130|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 2 (after 1 day of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure.||Liters||Standard Error|Least Squares Mean
72668|NCT01079130|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 15 (after 2 weeks of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
72669|NCT01078974|Primary|Tolerability of Pomalidomide|Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy|2 years|||participants|||Number
72670|NCT01078974|Primary|Maximum Tolerated Dose of Pomalidomide|To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.|2 years|The maximum tolerated dose was not determined due to study termination. Three participants experienced IgM flare causing them to be removed from the study early.||mg|||Number
72671|NCT01078922|Secondary|Overall Clinical Benefit (OCB)|"OCB = # patients with a CR + # of patients with a PR + # patients with Stable Disease (SD) divided by the number of evaluable patients CR and PR is defined in Outcome Measure #1~SD is defined as:~Failure to attain CR/PR or Progressive Disease (PD)~PET remains positive.~PD is defined as:~Any new lesion > 1.5 cm in longest axis~An increase 50% or more of previously involved sites from nadir~50% increase in SPD of more than one node or 50% increase in the longest diameter of a previously identified node that is > 1 cm in shortest axis~PET remains positive if it was positive before therapy."|Evaluated every 2 cycles (every 2 months), up to 80 weeks|||percentage of participants|||Number
72672|NCT01078922|Primary|Overall Response (OR)|"OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients.~A CR is defined as:~Disappearance of all disease.~If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative~If the nodal masses were Variably or PET negative; they must regress to normal.~No palpable liver or spleen~Palpable nodal masses are no longer palpable~Negative bone marrow biopsy~A PR is defined as:~Regression of measurable disease and no new sites of disease.~> 50% decrease in Sum of Product of Diameters (SPD) of up to 6 largest masses with no increase in the size of other nodes. If the nodal masses were PET positive prior to therapy then PET positive at previously involved sites is allowed. If they were Variably or PET negative then regression on CT is required.~No increase in the size of the liver or spleen"|evaluated every 2 months up to 80 weeks|Analysis was per protocol. Patients were evaluated every 2 cycles for Overall Response, up to 80 weeks.||percentage of participants|||Number
72673|NCT01078805|Secondary|Physician Criteria for Initiating FORTEO Therapy|Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here.|Baseline|Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. This is a baseline characteristic; therefore data are presented in the section of Baseline Characteristics.||participants|||Number
72674|NCT01078805|Secondary|Percentage Change From Baseline in Bone Area at Month 24 Endpoint|Bone area is a defined region of interest of bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.||percent change of centimeter square||Standard Error|Mean
72675|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint|BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.||percentage (%) change of grams (g)||Standard Error|Mean
72676|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint|A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.||percentage (%) change of BMD||Standard Error|Mean
72681|NCT01078805|Primary|Percentage of Participants With Non-Vertebral Fragility Fractures|Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.||Percentage of participants|||Number
72682|NCT01078753|Secondary|Change in Number of Wet Nights Between Treatment Periods I and II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II.|Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)|The full analysis set.||wet nights||95% Confidence Interval|Least Squares Mean
72683|NCT01078753|Secondary|Change in Number of Wet Nights Between Baseline and Treatment Period I|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I.|Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).|The Full analysis set.||wet nights||95% Confidence Interval|Least Squares Mean
72684|NCT01078753|Primary|Change in the Number of Wet Nights Between Baseline and Treatment Period II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.|Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).|The Full Analysis Set (FAS) included all participants who received at least one dose of study treatment, satisfied all the major eligibility criteria and for whom efficacy data was obtained.||wet nights||95% Confidence Interval|Least Squares Mean
72685|NCT01078675|Secondary|Overal Treatment Adherence|Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set||Percent of doses||Standard Deviation|Mean
72686|NCT01078675|Primary|Single Dose PK - AUC(0-24)|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set||ng*hr/mL||Standard Deviation|Mean
72687|NCT01078675|Primary|Single Dose PK - Tmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set||hr||Standard Deviation|Mean
72688|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 24|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set||Participants|||Number
72689|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 12|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set||Participants|||Number
72690|NCT01078675|Primary|Percent Change From Baseline in Height|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Safety Population||Percent change||Standard Deviation|Mean
72691|NCT01078675|Secondary|Total Duration of Exposure|Total duration of exposure was calculated as [last dose date of rosuva - first dose date of rosuva + 1 day]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set||Days||Standard Deviation|Mean
72692|NCT01078675|Secondary|Adverse Events|Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set||Participant|||Number
72693|NCT01078675|Secondary|Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT)|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Intent-to-treat analysis set (LOCF) and healthy siblings||mm||Standard Deviation|Mean
72694|NCT01078675|Secondary|Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set (LOCF)||Percent change||Standard Deviation|Mean
72695|NCT01078675|Primary|Single Dose PK - Cmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours.|Single dose PK analysis set||ng/mL||Standard Deviation|Mean
72696|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Baseline|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set||Participants|||Number
72697|NCT01078675|Primary|Percent Change From Baseline in LDL-C|Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set and Per-protocol analysis set||Percentage change||Standard Deviation|Mean
72698|NCT01078662|Secondary|Disease Control Rate at Week 16|Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16|Full analysis set - all treated patients||Percentage of participants||95% Confidence Interval|Number
72699|NCT01078662|Secondary|Duration of Response|Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.|From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months|Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.||days||Inter-Quartile Range|Median
72700|NCT01078662|Secondary|Overall Survival Rate at 12 Months|Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.||Percentage of participants|||Number
72701|NCT01078662|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.||months||Inter-Quartile Range|Median
72702|NCT01078662|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.||months||Inter-Quartile Range|Median
72703|NCT01078662|Secondary|Objective Response Rate|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline||Percentage of participants||95% Confidence Interval|Number
72704|NCT01078662|Primary|Tumour Response Rate|Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients||Percentage of participants||95% Confidence Interval|Number
72705|NCT01078623|Secondary|Change From Baseline in Morning Peak FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1||Liters||Standard Error|Least Squares Mean
72706|NCT01078623|Secondary|Change From Baseline in Morning Pre-dose FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes|Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1||Liters||Standard Error|Least Squares Mean
72707|NCT01078623|Primary|Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1||Liters||Standard Error|Least Squares Mean
72708|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question “Are you satisfied with your current hypertension therapy?”. The range of responses varied from “1 = not at all satisfied” to “5 = extremely satisfied.” Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|Subset of participants from the ITT cohort who answered the satisfaction questions at both the Baseline and 12-Month visits.||percentage of participants|||Number
72709|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|12 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).||percentage of participants|||Number
72710|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|6 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with blood pressure measurement at given time point).||percentage of participants|||Number
72711|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|3 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).||percentage of participants|||Number
72712|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication discontinued.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
72713|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication discontinued.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
72714|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication discontinued.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
72715|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication added.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
72716|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication added.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
72717|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication added.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).||participants|||Number
72718|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|12 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).||percentage of participants|||Number
72719|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|6 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).||percentage of participants|||Number
72720|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|3 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).||percentage of participants|||Number
72721|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 12 Months||12 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).||participants|||Number
72722|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 6 Months||6 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).||participants|||Number
72723|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 3 Months||3 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).||participants|||Number
72724|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 12 Months|Compliance after 12 months of treatment was derived using responses to the question “How many trandolapril doses have been missed since the subject’s last visit?” at Visit 2, Visit 3 and Visit 4, as follows: if the response was “zero” at all of the Visits 2 through 4 assessments, the participant was classified as “compliant” after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as “non-compliant” after 12 months of treatment.|12 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).||participants|||Number
72725|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 6 Months|Compliance after 6 months of treatment was derived using responses to the question “How many trandolapril (Mavik®) doses have been missed since the subject’s last visit?” at both Visit 2 and Visit 3, as follows: If the response was “zero” at both the Visit 2 and Visit 3 assessments, participant was classified as “compliant” after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as “non-compliant” after 6 months of treatment|6 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).||participants|||Number
72726|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 3 Months|Compliance after 3 months of treatment was derived using responses to the Visit 2 question “How many trandolapril (Mavik®) doses have been missed since the subject’s last visit?” If the response was “zero”, the participant was classified as “compliant.” If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as “non-compliant.”|3 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).||participants|||Number
72727|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12||Day 0 (Baseline), Month 12|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
72728|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6||Day 0 (Baseline), Month 6|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
72729|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3||Day 0 (Baseline), Month 3|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
72730|NCT01078584|Other Pre-specified|Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts||Day 0 (Baseline)|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).||mm Hg||95% Confidence Interval|Mean
72731|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months||Day 0 (Baseline), 12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given timepoint).||mm Hg||95% Confidence Interval|Mean
72732|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months||Day 0 (Baseline), 6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||mm Hg||95% Confidence Interval|Mean
72733|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months||Day 0 (Baseline), 3 Months|ITT cohort. n = all evaluable participants in the ITT cohort with blood pressure measurement at given timepoint.||mm Hg||95% Confidence Interval|Mean
72734|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|12 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).||percentage of participants|||Number
72735|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|6 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).||percentage of participants|||Number
72736|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|3 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).||percentage of participants|||Number
72737|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||percentage of participants|||Number
72738|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||percentage of participants|||Number
72739|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy|Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|3 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).||percentage of participants|||Number
72740|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|ITT cohort. n=evaluable participants from the ITT cohort who answered the satisfaction questions at Baseline and 12-Month visits.||percentage of participants|||Number
72741|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|12 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).||percentage of participants|||Number
72785|NCT01078376|Primary|Apparent Oral Clearance (CL/F) for TAK-536|CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||L/hr||Standard Deviation|Mean
72742|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|6 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).||percentage of participants|||Number
72743|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|3 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).||percentage of participants|||Number
72744|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 12 Months||Baseline, 12 months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).||mg/L||95% Confidence Interval|Mean
72745|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 6 Months||Baseline, 6 Months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).||mg/L||95% Confidence Interval|Mean
72746|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 3 Months||Baseline, 3 Months|Evaluable participants (all participants in the ITT cohort with MAU measurement at given time point).||mg/L||95% Confidence Interval|Mean
72747|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline,12 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).||mL/min||95% Confidence Interval|Mean
72748|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 6 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).||mL/min||95% Confidence Interval|Mean
72749|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 3 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).||mL/min||95% Confidence Interval|Mean
72750|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|12 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).||percentage of participants|||Number
72751|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|6 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).||percentage of participants|||Number
72752|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|3 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).||percentage of participants|||Number
72753|NCT01078571|Secondary|Radiological Evaluation of Rheumatoid Arthritis (RA).|Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.|Baseline and 12 months|This analysis was conducted in the intent-to-treat population (591 participants total).||Participant|||Number
72754|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.|Baseline and 12 Months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.||Percentage change||Standard Deviation|Mean
72755|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).|Baseline and 12 months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.||Units on a scale||Standard Deviation|Mean
72786|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Standard Deviation|Mean
75771|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||Baseline||||||
72756|NCT01078571|Secondary|Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.|The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.|Baseline, 1, 4, 6, and 12 months|This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.||Joints||Standard Deviation|Mean
72757|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented."|Baseline and 12 months|Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.||Percentage reduction||Standard Deviation|Mean
72758|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented."|Baseline and 12 months|Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.||Units on a scale||Standard Deviation|Mean
72759|NCT01078571|Primary|Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment|The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.|Baseline, 1, 4, 6, and 12 months|This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).||Participants|||Number
72760|NCT01078545|Secondary|Reported Adverse Events/Serious Adverse Events|Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.||Participants|||Number
72761|NCT01078545|Secondary|Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.|Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.||Units on a scale||Full Range|Median
72762|NCT01078545|Secondary|Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.|Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline|Analysis conducted in the intent-to-treat population.||Percentage of participants|||Number
72763|NCT01078545|Secondary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.||units on a scale||Standard Deviation|Mean
72764|NCT01078545|Primary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.||units on a scale||Standard Deviation|Mean
75772|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||Baseline||||||
72765|NCT01078454|Primary|Proportion of Patients With Hematologic Overall Response (Partial Response [PR]+ Very Good PR [VGPR]+ Amyloid Complete Response [ACR]+ Stringent Complete Response [sCR]) After 3 Months (3 Cycles) of Therapy|sCR: ACR and no clonal cells in bone marrow (BM) ACR: Negative serum/urine immunofixation (IF), <5% plasma cells in BM, and normal serum FLC ratio VGPR: 1. PR and any of the following; 2. serum/urine M-protein detectable by IF but not measurable (NM) on electrophoresis (EP); (3) ≥90% reduction in serum M-component and urine M-protein <100 mg/24 hr if baseline serum measurable; (4) urine M-component <100 mg/24 hr and NM serum M-protein on serum protein EP if baseline urine measurable; (5) ≥90% drop in the difference between involved and uninvolved FLC levels if only FLC measurable PR: (1) ≥50% drop of serum M-protein and 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline serum/urine measurable; or (2) ≥50% drop of serum M-protein if only serum measurable at baseline; or (3) 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline urine measurable; or (4) ≥ 50% drop in the difference between involved and uninvolved FLC if only FLC measu|Assessed at 3 months|All enrolled patients are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
72766|NCT01078441|Primary|One-year Survival in Patients Treated With This Regimen.|Proportion of patients who are still alive at 1 year after registration.|Assessed at 1 year|All eligible and treated patients are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
72767|NCT01078402|Secondary|Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.|From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||participants|||Number
72768|NCT01078402|Secondary|Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy|Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.|From first treatment until study discontinuation, up to 13 months.|Participants in the SES who discontinued therapy and had evaluable records. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||weeks||Standard Deviation|Mean
72769|NCT01078402|Secondary|Compliance With the Humira Administration Schedule at Month 13 (End of Study)|Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.|Month 13|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||participants|||Number
72770|NCT01078402|Secondary|Participant Acceptability of Self-injection at Month 13 (End of Study)|Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator’s opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.|13 months|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.||percentage of participants|||Number
72771|NCT01078402|Secondary|Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy|HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline, 4, 7 and 13 months|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented. n=number of participants with evaluable records at given time point.||units on a scale||Standard Deviation|Mean
72772|NCT01078402|Primary|Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS|BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.||participants|||Number
72773|NCT01078402|Primary|Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA|DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.||participants|||Number
72787|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||hr||Standard Deviation|Mean
72774|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of the single affected joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) and Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst). The Erosion Score and the JSN Score were summed for the Total Score. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
72775|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Magnetic Resonance Imaging (MRI) was evaluated using the Rheumatoid Arthritis MRI Score (RAMRIS). Bone erosion in the proximal and distal location were each assessed in the affected joint using an 11-point scale where 0=no erosion (best) to 10=91-100% bone eroded (worst) for a bone erosion score range of 0 to 20. Bone marrow edema in the proximal and distal location were each assessed using a 4-point scale where 0=no edema (best) to 3=67-100% edema (worst) for a bone marrow edema (BME) score range of 0 to 6. Synovitis was assessed in the affected joint using a 4-point scale where 0=normal (best) to 3=severe (worst). Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
72776|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
72777|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst) for a total JSN score range of 0 to 208. The Erosion Score and the JSN Score were combined for a total possible score of 0 to 528. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.||score on a scale||Standard Deviation|Mean
72778|NCT01078389|Primary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available for analysis and missing values at Month 24 imputed using linear extrapolation are included in the analysis.||score on a scale||Standard Deviation|Mean
72779|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||L/hr||Standard Deviation|Mean
72780|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||L/hr||Standard Deviation|Mean
72781|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||percent||Standard Deviation|Mean
72782|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||percent||Standard Deviation|Mean
72783|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||mg||Standard Deviation|Mean
72784|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||mg||Standard Deviation|Mean
72790|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng/mL||Standard Deviation|Mean
72791|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng/mL||Standard Deviation|Mean
72792|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
72793|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
72794|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
72795|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.||ng.hr/mL||Standard Deviation|Mean
72796|NCT01078363|Secondary|Index of Microcirculatory Resistance at One Year Post Heart Transplant|The index of microcirculatory resistance (IMR) is a pressure-temperature sensor guidewire-based measurement, performed during cardiac catheterization, of the minimum microcirculatory resistance in a specific coronary artery. The IMR provides a quantitative measure of coronary microvasculature status.|one year|Only a subset of participants (adult patients enrolled at Stanford University) underwent index of microcirculatory resistance assessment.||mmHg x seconds||Standard Deviation|Mean
72797|NCT01078363|Secondary|Fractional Flow Reserve (FFR) at One Year Post Transplant|FFR is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia). It is defined as the ratio of the distal coronary pressure to the proximal coronary pressure.|at one year post Transplant|Only a subset of participants (adult patients enrolled at Stanford University) underwent fractional flow reserve assessment.||Ratio||Standard Deviation|Mean
72798|NCT01078363|Secondary|The Percentage of Endothelial Progenitor Cells ( EPC) in Peripheral Blood in Patients One Year After Transplant|The determination of the percentage of EPC in peripheral blood involved surface staining peripheral blood mononuclear cells (PBMCs) with appropriate fluorescently-labeled antibodies to delineate EPCs from other blood cells, followed by analysis by conventional flow cytometry.|at one year|Not all blood samples obtained were adequate for EPC determination which explains the discrepancy in number of participants analyzed.||percentage of EPC||Standard Deviation|Mean
72799|NCT01078363|Secondary|ADMA Level at One Year Post Transplant|asymmetric dimethylarginine (ADMA), is an inhibitor of endothelial nitric oxide synthase which is a primary regulator of endothelial function.|1 year post Transplant|Blood samples were not acquired in all participants which accounts for the discrepancy in number of participants analyzed.||micromole||Standard Deviation|Mean
72800|NCT01078363|Secondary|Percentage of Participants With ≥20% Coronary Artery Diameter Reduction After Acetylcholine|The percent change in diameter of the left anterior descending artery was measured by quantitative angiography after acetylcholine and compared to baseline angiography. The percentage of participants who had ≥20% coronary artery diameter reduction after acetylcholine at one year is presented.|At Baseline and 1 Year|Only a subset of participants (those adult patients enrolled at Stanford University) underwent the acetylcholine measurements.||percentage of participants|||Number
72801|NCT01078363|Primary|Cardiac Allograft Vasculopathy(CAV) Defined as Change in IVUS-assessed Plaque Volume From Baseline to One Year|also called transplant coronary artery disease or cardiac transplant vasculopathy defined as coronary artery stenosis(narrowing) ranging from 30 to 70 percent by coronary angiography. Measured in this study as change in IVUS-assessed Plaque Volume from baseline to one year.|Baseline and 1 Year|||mm3/mm||Standard Deviation|Mean
72802|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4)(“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.||participants|||Number
72803|NCT01078298|Other Pre-specified|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score|The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||Units on a scale||Standard Deviation|Mean
72804|NCT01078298|Other Pre-specified|Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||Units on a scale||Standard Deviation|Mean
72805|NCT01078298|Other Pre-specified|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||Units on a scale||Standard Deviation|Mean
72806|NCT01078298|Other Pre-specified|Number of Participants With Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specific categories for each arm group.||participants|||Number
72807|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
72808|NCT01078298|Other Pre-specified|Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)|Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.|Baseline up to Week 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.||participants|||Number
72809|NCT01078298|Secondary|Number of Participants With 4-Week Point Prevalence (PP) of Abstinence|Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||participants|||Number
72810|NCT01078298|Secondary|Number of Participants With 7-day Point Prevalence (PP) of Abstinence|Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Weeks 12, 24, 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||participants|||Number
72811|NCT01078298|Secondary|Percentage of Participants With Continuous Abstinence Rate (CAR)|Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 9 through Week 24, Week 9 through Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||Percentage of participants|||Number
72812|NCT01078298|Primary|Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)|"Percentage of participants who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) questions: ‘Has the participant smoked cigarettes’ and ‘Has the participant used other nicotine-containing products’ in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm)."|Week 9 through Week 12|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.||Percentage of participants|||Number
72813|NCT01078246|Secondary|Incidence of All-cause Mortality|All-cause mortality occurring during the risk period was identified through the use of computer-stored records of Emergency Department visits, hospitalizations, and state death certificates. Deaths were identified from administrative Kaiser Permanente databases, including Kaiser Permanente regional research and respective state(s) mortality files as well as the Social Security Administrative files. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
72838|NCT01078155|Secondary|Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24|Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||units on a scale||Standard Deviation|Mean
72814|NCT01078246|Secondary|Incidence of Clinically Important Cardiovascular Events|Significant cardiovascular events occurring during the risk period were identified through the use of computer-stored records and defined as inpatient events based on algorithms that utilize a combination of diagnosis and/or procedure codes. The identification of potential significant cardiovascular events was based on the occurrence of major adverse cardiovascular events (MACE) which include acute myocardial infarction (MI), ischemic stroke, unstable angina, revascularization (e.g. percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG)), and cardiovascular death. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
72815|NCT01078246|Primary|Incidence of Lipodystrophy|Lipodystrophy (e.g. lipoatrophy, facial wasting) occurring during the risk period was identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential lipodystrophy was based on two coded diagnoses codes indicative of lipodystrophy appearing at least 6 months apart over the course of patient care, the identification of interventions to treat such conditions (e.g. sculptra therapy), or procedural codes for Computerized Tomography indicating incident neck or abdominal lipoaccumulation. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
72816|NCT01078246|Primary|Incidence of Clinically Important Muscle Events|Significant muscle events (e.g. rhabdomyolysis) occurring during the risk period were identified through the use of computer-stored records of laboratory values, outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant muscle events was based on algorithms utilizing a combination of diagnoses, procedures and/or laboratory results for creatinine kinase. The number of muscle events did not meet the threshold for statistical analysis per protocol. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
72817|NCT01078246|Primary|Incidence of Clinically Important Skin Events|Significant skin events (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) occurring during the risk period were identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant skin events was based on algorithms utilizing a combination of diagnoses, procedures and/or medications. Surveillance of outpatient visits was limited to rashes coded as drug-related and requiring use of steroid (e.g. prednisone) administration. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
72818|NCT01078246|Primary|Incidence of Clinically Important Hepatic Events|Hepatic events occurring during the risk period were identified through computer-stored records of laboratory values, outpatient visits, Emergency Department visits, and hospitalizations. Significant hepatic events were identified based on algorithms utilizing a combination of diagnoses, procedures, and laboratory results. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
72819|NCT01078246|Primary|Incidence of AIDS-defining and Non-AIDS-defining Malignancy|All new malignancies occurring during the risk period, including Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancies, were identified through the Kaiser Permanente cancer registries. The registry data was supplemented by the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations to identify cancers that would not be captured through the cancer registries (e.g. cutaneous Kaposi’s sarcoma).The AIDS-defining malignancies reported for any cohort were invasive cervical cancer, Kaposi's sarcoma, and non-Hodgkin lymphoma. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.||Events per 1000 person-years of followup||95% Confidence Interval|Number
72820|NCT01078233|Primary|Incidence of All-Cause Mortality|All participant deaths were recorded|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Participants|95% Confidence Interval|Number
72821|NCT01078233|Primary|Incidence of Lipodystrophy|Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Participants|95% Confidence Interval|Number
72822|NCT01078233|Primary|Incidence of Clinically Important Hepatic Events|Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Participants|95% Confidence Interval|Number
73043|NCT01077258|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 3, 6, 9, 18, and 24|Full analysis set with available data at each time point||percentage of participants|||Number
72823|NCT01078233|Primary|Incidence of Malignancy|All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.||Events per 100 person-years of follow-up|Participants|95% Confidence Interval|Number
72824|NCT01078220|Primary|Incidence Rate of Cellulitis|Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a “rule out” diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.|Within 14 days and within 60 days immediately after each vaccination|||Rate per 1000 person years|||Number
72825|NCT01078220|Secondary|Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil|"Autoimmune cases were defined as newly diagnosed cases within 6 months after any~dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest."|within 6 months immediately after each vaccination|Number of females with at least 12 months' membership at a MCO prior to Gardasil.||Number of autoimmune cases|||Number
72826|NCT01078220|Secondary|Number of Miscarriages Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to pregnancy resolution|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.||Number of miscarriages|||Number
72827|NCT01078220|Secondary|Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to 6 months after birth|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.||Number of congenital anomalies|||Number
72828|NCT01078220|Primary|Incidence Rate of Syncope|Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a “rule out” diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.|On day of each vaccination|||Rate per 1000 person years|||Number
72829|NCT01078207|Secondary|Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.|The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.|12 hours after discharge form the recovery room|All patients with a positive repetitive reduction in nasal airflow.||participants|||Number
72830|NCT01078207|Primary|Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.|Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects|12 hour after released from the recovery room|All patients with complete data were analyzed.||participants|||Number
72831|NCT01078155|Secondary|Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24|ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||mm/1 hour||Standard Deviation|Mean
72832|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject’s Assessment of Pain at Baseline, Month 3, Month 12, Month 24|Subject’s Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||units on a scale||Standard Deviation|Mean
72833|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject’s Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Subject’s Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||units on a scale||Standard Deviation|Mean
72834|NCT01078155|Primary|Tender Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||joints||Standard Deviation|Mean
72835|NCT01078155|Primary|Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24|"Participant-reported the existence and duration of morning stiffness, defined as morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||minutes||Standard Deviation|Mean
72836|NCT01078155|Primary|Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.||µg/L||Standard Deviation|Mean
72837|NCT01078155|Secondary|Visual Analogue Scale (VAS): Physician’s Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Physician’s Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit, with evaluable data at time points.||units on a scale||Standard Deviation|Mean
72839|NCT01078155|Secondary|Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||joints||Standard Deviation|Mean
72840|NCT01078155|Primary|Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.||ng/mL||Standard Deviation|Mean
72841|NCT01078155|Primary|Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.||µg/L||Standard Deviation|Mean
72842|NCT01078155|Primary|Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24|T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||standard deviations||Standard Deviation|Mean
72843|NCT01078155|Primary|Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24|BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.||g/cm^2||Standard Deviation|Mean
72844|NCT01078116|Primary|Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)|The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years [QALYs]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).|12 months|Cost-utility analysis is based on the 76 participants who completed the study through 12 months.||Euros|||Number
72845|NCT01078116|Primary|Health Related Quality of Life (Medical Outcome Study Short Form 36)|Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.||Units on a scale||Standard Deviation|Mean
72846|NCT01078116|Primary|Health Related Quality of Life (Health Assessment Questionnaire)|Health Assessment Questionnaire (HAQ) is designed to assess patients’ abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.||units on a scale||Standard Deviation|Mean
72847|NCT01078116|Primary|Health Related Quality of Life (European Quality of Life 5 Dimensions)|European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.||Units on a scale||Standard Deviation|Mean
72848|NCT01078116|Primary|Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment|Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.||Euros||Standard Deviation|Mean
72849|NCT01078090|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
72850|NCT01078090|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)||percentage of participants|||Number
72851|NCT01078090|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)||days||Standard Deviation|Mean
72852|NCT01078090|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 6, 18, 24, and 30|Full analysis set (FAS) participants with available data at each time point.||percentage of participants|||Number
75773|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||Baseline||||||
72853|NCT01078090|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||cm||Standard Deviation|Mean
72854|NCT01078090|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||cm||Standard Deviation|Mean
72855|NCT01078090|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||cm||Standard Deviation|Mean
72856|NCT01078090|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
72857|NCT01078090|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||swollen joints||Standard Deviation|Mean
72858|NCT01078090|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||tender joints||Standard Deviation|Mean
72859|NCT01078090|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||mg/L||Standard Deviation|Mean
72860|NCT01078090|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||mm/hour||Standard Deviation|Mean
72861|NCT01078090|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.~The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set (FAS) participants with available data at each time point.||percentage of participants|||Number
72862|NCT01078090|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.~The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
72863|NCT01078090|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a DAS28 score of < 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
75774|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||Baseline|||percent of total fat mass||Standard Deviation|Mean
72864|NCT01078090|Primary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.~A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
72865|NCT01077973|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
72866|NCT01077973|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.||Percentage of participants|||Number
72867|NCT01077973|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.||Minutes||95% Confidence Interval|Median
72868|NCT01077973|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
72869|NCT01077973|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Percentage of participants|||Number
72870|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
72871|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
72872|NCT01077973|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
72873|NCT01077973|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
72874|NCT01077973|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
72875|NCT01077973|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
72894|NCT01077921|Secondary|Overall Change of Plasma Levels of sP-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sP-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and weeks 8 to 14).|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
72876|NCT01077973|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
72877|NCT01077973|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
72878|NCT01077973|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.||Minutes||95% Confidence Interval|Median
72879|NCT01077973|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 3 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.||Units on a scale||Standard Deviation|Mean
72880|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||mg/dL||Standard Deviation|Mean
72881|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||mg/dL||Standard Deviation|Mean
72882|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin|Oral glucose tolerance testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||mcIU/mL||Standard Deviation|Mean
72883|NCT01077960|Secondary|Change From Baseline to Week 12 in Insulin-like Growth Factor I|Circulating levels of IGF-I|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||ng/mL||Standard Deviation|Mean
72884|NCT01077960|Secondary|Change From Baseline to Week 12 in Waist Circumference|Measured by anthropometry|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||cm||Standard Deviation|Mean
72885|NCT01077960|Primary|Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan||baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug||kg||Standard Deviation|Mean
72886|NCT01077921|Secondary|Overall Change of Diastolic Blood Pressure Levels|Overall change of Diastolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||mmHg||Inter-Quartile Range|Median
72887|NCT01077921|Secondary|Overall Change of Systolic Blood Pressure Levels|Overall change of Systolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||mmHg||Inter-Quartile Range|Median
72888|NCT01077921|Secondary|Overall Change of Oxygen Saturation (02Sat) Levels|Overall change of Oxygen Saturation (02Sat) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||percentage of oxygen saturation||Inter-Quartile Range|Median
72889|NCT01077921|Secondary|Overall Change of Lactate Dehydrogenase (LDH) Levels|Overall change of LDH levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||IU/L||Inter-Quartile Range|Median
72890|NCT01077921|Secondary|Overall Change of Hematocrit (Hct) Levels|Overall change of Hematocrit (Hct) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||percentage of red blood cells||Inter-Quartile Range|Median
72891|NCT01077921|Secondary|Overall Change of Hemoglobin (Hgb) Levels|Overall change of Hemoglobin (Hgb) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14|||gm/dL||Inter-Quartile Range|Median
72892|NCT01077921|Secondary|Overall Change of Plasma Levels of sVCAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sVCAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 or week 8 to 14)|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
72893|NCT01077921|Secondary|Overall Change of Plasma Levels of sICAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sICAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14)|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
72895|NCT01077921|Primary|SS RBC Adhesion (Epi -3d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 3 dyne/cm2|Week 0 to 6 and week 8 to 14|||Percentage of total RBC||Standard Deviation|Mean
72896|NCT01077921|Primary|SS RBC Adhesion (Epi -2d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 2 dyne/cm2|Week 0 to 6 and week 8 to 14|||Percentage of total RBC||Standard Deviation|Mean
72897|NCT01077921|Secondary|Overall Change of Plasma Levels of sE-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sE-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14).|Week 0 to 6 and week 8 to 14|||ng/ml||Standard Deviation|Mean
72898|NCT01077921|Primary|SS RBC Adhesion (Epi -1d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 1 dyne/cm2|Week 0 to 6 and week 8 to 14|||Percentage of total RBC||Standard Deviation|Mean
72899|NCT01077856|Secondary|Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status|The percentage of participants with liquid-based cervical cytology samples positive for HPV 6, 11, 16, and 18 was to be analyzed by Gardasil vaccination status.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
72900|NCT01077856|Secondary|Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status|The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
72901|NCT01077856|Secondary|Incidence of Cervical Cancer by Gardasil Vaccination Status|The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
72902|NCT01077856|Secondary|Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status|The incidence of CIN by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.|||||
72903|NCT01077856|Primary|Percentage of Live Born Babies With a Major Congenital Anomaly|The percentage of live born babies with major congenital anomalies (MCA) born to women vaccinated with Gardasil during pregnancy and to women in the general population was assessed. For Denmark and Sweden diagnoses of congenital anomaly within 1 year of birth are included; for Norway diagnoses at birth are included.|Up to 5 years after Gardasil licensure (2007 to 2011)|The analysis population represents the babies born to participating mothers, instead of female participants, because the number of babies represents the denominator for the percentage calculation, not female participants (i.e., mothers)||Percentage of babies with a MCA|||Number
72904|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
72905|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
72933|NCT01077804|Secondary|Incidence Rate of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed.|From 6 weeks to 168 months (14 years) post vaccination|||Rate per 1000 person years||95% Confidence Interval|Number
73353|NCT01074463|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
72906|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
72907|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types||Percentage of participants||95% Confidence Interval|Number
72908|NCT01077856|Primary|Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors|The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|Analysis of this endpoint was not planned nor were the data collected. Thus, the number of participants analyzed is zero.|||||
72909|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72910|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72911|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72912|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72934|NCT01077804|Primary|Incidence Rate of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination|||Rate per 1000 person years||95% Confidence Interval|Number
72935|NCT01077804|Primary|Number of Participants With an Occurrence of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination|||Participants|||Number
72913|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72914|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72915|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72916|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72917|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72918|NCT01077856|Primary|Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants of all ages with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types||Cases per 100,000 women|||Number
72919|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72920|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72921|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72922|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women >26 years of age were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of women >26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72923|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72924|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72925|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72936|NCT01077804|Secondary|Number of Participants With an Occurrence of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed cases.|From 6 weeks to 168 months (14 years) post vaccination|||Participants|||Number
73354|NCT01074463|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
72926|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72927|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.||Cases per 100,000 women|Participants||Number
72928|NCT01077830|Primary|Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort|Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.|up to 21 Months after the end of the SEAS (base) study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.||per 100 participant-years||95% Confidence Interval|Number
72929|NCT01077830|Secondary|Crude Rate of Death Due to Cancer - Follow-up Primary Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.|up to 21 Months after the end of the base study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.||per 100 participant-years||95% Confidence Interval|Number
72930|NCT01077830|Secondary|Crude Rate of Death (Any Cause) - Follow-up Total Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.|up to 21 Months after the end of the base study|Primary analysis population was Follow-Up Total Cohort defined as all participants enrolled in the study.||per 100 participant-years||95% Confidence Interval|Number
72931|NCT01077817|Primary|Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)|To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used.|Up to approximately 7.3 years of follow-up|Inception Cohort came from the Overall Study Population beginning treatment with an osteoporosis study drug (initiators, 78,630 women) and 300,610 matched control women, who did not receive study drug (noninitiators). Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.||Number of cases per 100,0000 woman-years|||Number
72932|NCT01077817|Primary|Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)|To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.|Exposure to study drug at least 720 days before disease onset|Case-Cohort analysis population came from the Overall Study Population and comprised 929 women with esophageal cancer (cases) and a Comparison Sample of 338,911 matched control women. Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.||Percentage of participants|||Number
72937|NCT01077739|Secondary|Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression|Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.|Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months|ITT Population. Number (n) equals (=) number of participants assessed for the given parameter at the specified visit.||pg/mL||Standard Deviation|Geometric Mean
72938|NCT01077739|Secondary|Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)|"Percentage of participants with an overall response of CR or PR according to RECIST criteria.~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population; only participants with RECIST evaluations were included in the analysis.||percentage of participants|||Number
72939|NCT01077739|Secondary|PFS From the Start of First-Line Therapy|PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population.||months||95% Confidence Interval|Median
72940|NCT01077739|Primary|Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression|PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population||months||95% Confidence Interval|Median
72941|NCT01077713|Secondary|Duration of Response (DoR)|DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set.||months||95% Confidence Interval|Median
72942|NCT01077713|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set||percentage of participants||95% Confidence Interval|Number
72943|NCT01077713|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set||percentage of participants||95% Confidence Interval|Number
72944|NCT01077713|Secondary|Percentage of Participants by Best Overall Response|Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set||percentage of participants||95% Confidence Interval|Number
72948|NCT01077713|Secondary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set||months||95% Confidence Interval|Median
72949|NCT01077713|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set||percentage of participants|||Number
72950|NCT01077713|Primary|Percentage of Participants Alive and Without Progressive Disease at Month 6|Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.|Month 6|Intent-to-treat (ITT) set included all participants in the RND set who received at least one dose of any study medication; participants were classified according to treatment received.||percentage of participants||95% Confidence Interval|Number
72951|NCT01077622|Secondary|Mean Residence Time (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr||95% Confidence Interval|Geometric Mean
72952|NCT01077622|Secondary|Volume of Distribution at Steady State (Vss) for Ofatumumab|Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||mL||95% Confidence Interval|Geometric Mean
72953|NCT01077622|Secondary|Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||mL||95% Confidence Interval|Geometric Mean
72954|NCT01077622|Secondary|Clearance (CL) of Ofatumumab From Plasma|CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||mL/hr||95% Confidence Interval|Geometric Mean
72955|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
72956|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24|Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 24|PK Parameter Population. Only participants contributing evaluable data at the indicated time points were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
72957|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7|Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 7|PK Parameter Population||hr*mcg/mL||95% Confidence Interval|Geometric Mean
72983|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of total neutrophils.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
75775|NCT01048593|Primary|Number of Participants With Clearing of Anterior Chamber Cells (ACC=0)||Day 8|||participants|||Number
72958|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab|AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr*mcg/mL||95% Confidence Interval|Geometric Mean
72959|NCT01077622|Secondary|Half-life (t1/2) of Ofatumumab|t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr||95% Confidence Interval|Geometric Mean
72960|NCT01077622|Secondary|Time to Reach Cmax (Tmax) Following Ofatumumab Administration|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||hr||Full Range|Median
72961|NCT01077622|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Weeks 7 and 24|PK Parameter Population||mcg/mL||95% Confidence Interval|Geometric Mean
72962|NCT01077622|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population: all participants who received at least one dose of investigational drug, and in whom PK data were available and allowed parameter estimations. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Micrograms per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
72963|NCT01077622|Secondary|Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
72964|NCT01077622|Secondary|Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48|HAHA are indicators of immunogenicity to ofatumumab.|Screening; Weeks 24 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
72965|NCT01077622|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.|Baseline and Weeks 8, 24, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||g/L||Standard Deviation|Mean
72966|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks|Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
72967|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks|Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
72968|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks|Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
72969|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks|Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||participants|||Number
72970|NCT01077622|Secondary|Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda|Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Ratio of Ig kappa/Ig lambda||Standard Deviation|Mean
72971|NCT01077622|Other Pre-specified|Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.|Weeks 36 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Kilo units per liter (KU/L)||Standard Deviation|Mean
72972|NCT01077622|Secondary|Number of Peripheral Blood CD23+ CD5+ Cells|CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72973|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD5+ Cells|CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72974|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD5+ Cells|CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72975|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD23+ Cells|CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72976|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD23+ Cells|CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72977|NCT01077622|Secondary|Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells|CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72978|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC|SERC assessed total neutrophils based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72979|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||percentage of lymphocytes in BM||Standard Deviation|Mean
72980|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
72981|NCT01077622|Secondary|Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC|SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Percentage of bone marrow infiltration||Standard Deviation|Mean
72982|NCT01077622|Secondary|Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of platelets.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||GI/L||Standard Deviation|Mean
75776|NCT01048593|Primary|Anterior Chamber Cells = 0 at Day 8 Post Treatment||Day 8 post treatment||||||
72984|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator|Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Percentage of lymphocytes in the BM||Standard Deviation|Mean
72985|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of lymphocytes.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Giga (10^9) per liter (GI/L)||Standard Deviation|Mean
72986|NCT01077622|Secondary|Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of hemoglobin.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
72987|NCT01077622|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC|Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.|Up to Week 48|All Subjects Population: only those participants who received CLL therapy were evaluated.||Weeks||95% Confidence Interval|Median
72988|NCT01077622|Secondary|Time to Response as Assessed by a SERC|Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.||Weeks||95% Confidence Interval|Median
72989|NCT01077622|Secondary|Overall Survival|Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.|Up to Week 48|All Subjects Population||Weeks||95% Confidence Interval|Median
72990|NCT01077622|Secondary|Duration of Response as Assessed by a SERC|Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.||Weeks||95% Confidence Interval|Median
72991|NCT01077622|Secondary|Progression-free Survival (PFS) as Assessed by a SERC|PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).|Up to Week 48|All Subjects Population: only those participants who progressed or died during the study were evaluated.||Weeks||95% Confidence Interval|Median
72992|NCT01077622|Primary|Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator|Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils >=1.5*10^9/liter (L), platelets >100*10^9/L, hemoglobin >11.0 grams/deciliter, lymphocytes (LC) <4.0*10^9/L, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.|Up to Week 48|All Subjects Population||Percentage of participants|||Number
72993|NCT01077622|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) >=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as >= G3 until the next day); and any of following: >= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).|Up to Week 8|All Subjects Population: all participants who received at least one dose of investigational drug. The first 3 participants enrolled in the study were evaluated for DLT according to study design.||participants|||Number
72994|NCT01077596|Secondary|Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with prostate cancer who were new antidepressant users.||participants|||Number
72995|NCT01077596|Secondary|Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with breast cancer who were new antidepressant users.||participants|||Number
72996|NCT01077596|Secondary|Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with uterine cancer who were new antidepressant users.||participants|||Number
72997|NCT01077596|Secondary|Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with bladder cancer who were new antidepressant users.||participants|||Number
72998|NCT01077596|Secondary|Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with lung cancer who were new antidepressant users.||participants|||Number
72999|NCT01077596|Secondary|Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with colorectal cancer who were new antidepressant users.||participants|||Number
73000|NCT01077596|Primary|Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant|The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users||participants|||Number
73001|NCT01077544|Secondary|Efficacy Endpoints for Ph+ ALL Patients|Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.||Participants|||Number
73002|NCT01077544|Secondary|Number of Ph+ CML Participants With Major Molecular Response (MMR)|The bcr-abl gene fusion encodes for a BCR-ABL fusion protein. Depending on the precise location of the fusion, the molecular weight of this protein can range from 185 to 210 kDa. Consequently BCR-ABL is referred to as p185 or p210 transcript. For the patients expressing the major BCR-ABL transcript p210, molecular response was defined and reported as the percent ratio of BCR-ABL transcripts/control gene transcripts converted to a reference standard according to the International Scale (IS). A major molecular response (MMR) is defined as a BCR-ABL/control gene ratio ≤ 0.1% (equal to a 3 log reduction in BCR-ABL transcripts) on the IS. In this study, the control gene was abl.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.||Participants|||Number
73003|NCT01077544|Secondary|Number of Ph+ CML Participants With Cytogenic Response|Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is > 0% to 35%, minor cytogenetic response (mCyR) is > 35% to 65%, minimal response is > 65% to 95% and no response is > 95% Ph+ metaphases in the BM.|minimum of 12 cycles (28 days per cycle)|FAS consist of all patients (pts) who passed screening & are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline & discontinued study prior to subsequent cytogenetic assessment. This pt doesn’t appear in any cytogenic response category.||Participants|||Number
73004|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: Cmin|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose.|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
73005|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||L/h/m^2)||Geometric Coefficient of Variation|Geometric Mean
73006|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: AUCss|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
75777|NCT01048541|Secondary|Median Absolute RU Volume||3 catheterisations on 1 day||||||
73007|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
73008|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h)|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
73009|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Tmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||h||Full Range|Median
73010|NCT01077544|Secondary|Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)|A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count < 10 × 109/L; platelet < 450 × 109/L; basophils < 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes < 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.||Participants|||Number
73011|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Cmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
73012|NCT01077375|Secondary|Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score|The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).|Change from Baseline (Week 3) to Visit 5 (Week 13)|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.||Units on a scale||Standard Deviation|Mean
73013|NCT01077375|Primary|Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)|The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.|Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.||participants|||Number
73014|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escaped, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
73015|NCT01077362|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.||Score on a scale||Standard Deviation|Mean
73028|NCT01077310|Primary|Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL|Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.|Baseline to month 6 post release|Logistic regression backward stepwise models were used to find predictors of HIV viral suppression.||percent of participants|||Number
75778|NCT01048541|Secondary|The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)||Study period||||||
73016|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
73017|NCT01077362|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.||Percentage of participants|||Number
73018|NCT01077362|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Score on a scale||Standard Deviation|Mean
73019|NCT01077362|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
73020|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Past Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is past use period, described as time following recent use excluding subsequent current or recent use."|43 months|Time on Drug Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
73021|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is the recent use period, described as time following current use plus an additional 31 days excluding subsequent current use."|43 months|Time on Drug Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
73022|NCT01077323|Secondary|Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis Among Initiators of Exenatide, Diabetics Initiating Other Antidiabetic Drugs, and the Non-diabetes Cohort - Intent to Treat Analysis|Crude intent-to-treat incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort.|43 months|Intent to Treat Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
73023|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is current use period, described as time during current day's supply plus 31 days."|43 months|Time on Drug Analysis||Cases per 100,000 person-years||95% Confidence Interval|Number
73024|NCT01077310|Other Pre-specified|Mean Change in CD4 Cell Count (Cells/mL)|Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.|Baseline and every 3 months for 1 year||12/2016||||
73025|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days|change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.|change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release|||percent of heavy drinking days||Standard Deviation|Mean
73026|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day|The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day|12 weeks prior to release from prison (baseline) to 6 months post release|||standard units of alcohol||Standard Deviation|Mean
73027|NCT01077310|Secondary|Alcohol Treatment Outcome: Time to Alcohol Relapse|Self reported time to first heavy drinking day after release from incarceration, up to 6 months|Post release|||days||Standard Deviation|Mean
73029|NCT01077284|Secondary|Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance|Creatinine clearance is a measure of how well the kidneys are filtering creatinine, a waste product produced by the muscles. Measured creatinine clearance was calculated according to the following: Urine 24 hour Creatinine/Serum Creatinine x (total Urine volume/elapsed time) x (1.73/body surface area).|Baseline and Month 6|Full analysis set. Missing Month 6 Visit 24-hour mCLcr values are imputed by Month 3 values if the Month 3 value was available otherwise the patient was excluded from the analysis.||mL/min/1.73m²||Standard Deviation|Mean
73030|NCT01077284|Secondary|Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones|Multidetector Computed Tomography (MDCT) was used to visualize and count calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader.|Baseline and Month 6|Full analysis set for whom both Baseline and Month 6 MDCT data were available. Measurements more than 1 day after a patient’s last dose of study drug were not included.||stones||Standard Deviation|Mean
73031|NCT01077284|Secondary|Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone|Multidetector Computed Tomography (MDCT) was used to visualize and measure calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader. The change from Baseline to month 6 is expressed as a percentage of the Baseline largest in-plane diameter.|Baseline and Month 6|Full analysis set, for whom Baseline and Month 6 MDCT data were available. Measurements more than 1-day after a patient's last dose of study drug were not included.||percent change||Standard Deviation|Mean
73032|NCT01077284|Primary|Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion|The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.|Baseline and Month 6|The full analysis set (patients who took at least 1 dose of double-blind study drug and had a baseline 24-hour uUA >700 mg and at least 1 kidney CaOx stone ≥3 mm in its longest inplane diameter). Missing Month 6 values were imputed with baseline values if patient discontinued due to an AE; or otherwise with the last available post-baseline value.||percent change||Standard Deviation|Mean
73033|NCT01077271|Secondary|Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale|The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.|One RSV season (5 months), end of study|The analysis included participants who were administered palivizumab and had data available for the study visits listed. A total of 100 participants were rated at the last study visit; 2 did not have ratings. A total of 18 participants who discontinued from the study were rated at the early termination visit.||units on a scale||Standard Deviation|Mean
73034|NCT01077271|Secondary|Parents Knowledge of Burden of RSV Disease Via Interview by Physician|"An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have “good RSV awareness if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly."|One RSV season (5 months)|The analysis included parents of participants who were administered and had data available for the study visits listed.||Parents of participants|||Number
73035|NCT01077271|Secondary|Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)|The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.|One RSV season (5 months)|The analysis included participants who were administered palivizumab and had data available for the study visits listed.||units on a scale||Standard Deviation|Mean
73036|NCT01077271|Primary|Dosage Per Administration|The median dose and range of palivizumab (milligrams) that was administered at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.||milligrams||Full Range|Median
73037|NCT01077271|Primary|Interval Between Administrations|The average number of days that elapsed between palivizumab injections administered at the previous study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.||Days||Standard Deviation|Mean
73038|NCT01077271|Primary|Body Site of Injections Per Administration|The body site of injection administration for participants at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.||participants|||Number
73039|NCT01077271|Primary|Number of Injections Per Patient Per Season|The average number of injections administered per participant within a respiratory syncytial virus season.|One RSV season (5 months)|Participants who were administered palivizumab were included in the analysis.||Injections administered||Standard Deviation|Mean
73040|NCT01077258|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
73041|NCT01077258|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Month 6, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
73042|NCT01077258|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, and 24|Full analysis set participants who were employed and with available data at each time point (indicated by n)||days||Standard Deviation|Mean
73044|NCT01077258|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||cm||Standard Deviation|Mean
73045|NCT01077258|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Month 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||cm||Standard Deviation|Mean
73046|NCT01077258|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18 and 24|Full analysis set with available data at each time point (indicated by n)||cm||Standard Deviation|Mean
73047|NCT01077258|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|"A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula:~FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||units on a scale||Standard Deviation|Mean
73048|NCT01077258|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||swollen joints||Standard Deviation|Mean
73049|NCT01077258|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||tender joints||Standard Deviation|Mean
73050|NCT01077258|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||mg/L||Standard Deviation|Mean
73051|NCT01077258|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||mm/hour||Standard Deviation|Mean
73052|NCT01077258|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.~Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point||percentage of participants|||Number
73053|NCT01077258|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
73054|NCT01077258|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient’s assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)||percentage of participants|||Number
73055|NCT01077258|Primary|Change From Baseline in Disease Activity Score (DAS) 28|The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
73355|NCT01074450|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
73056|NCT01077193|Primary|Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward|"Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.~One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL"|3 years|||percentage of baseline excess weight||Standard Deviation|Mean
73057|NCT01077128|Secondary|Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization|An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|||Participants|||Number
73058|NCT01077128|Secondary|Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.~It has two components:~the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and~the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either “problem” or “no problem” with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||units on a scale||Standard Deviation|Mean
73059|NCT01077128|Secondary|"Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)"|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.~It has two components:~the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and~the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either “problem” or “no problem” with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||Percentage of patients with no problem|||Number
73060|NCT01077128|Secondary|Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician’s Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region|The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician’s Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants’ quality of life.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||units on a scale||Standard Deviation|Mean
73061|NCT01077128|Secondary|Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician’s Global Assessment of Disease Severity (PGA) Scores|The Physician's Global Assessment of disease severity (PGA) was used to measure participants’ disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||Percentage of patients improving|||Number
73062|NCT01077128|Primary|Mean Change of Dermatology Life Quality Index (DLQI) Scores|DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.|12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point||units on a scale||Standard Deviation|Mean
73063|NCT01077076|Primary|Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment|Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments|4 hours after dose on Day 4|"Pharmacodynamic-Evaluable Population: All participants who presented valid data from all three study periods.~One participant was dropped from the Pharmacodynamic-Evaluable Population in the Prilosec OTC Tablets group because of invalid pH tracings at Day 4. Therefore, the number of participants included at Day 4 in this group was 26."||Percentage of Time||Standard Deviation|Mean
73064|NCT01077063|Primary|Safety of Pleurx Catheter or Paracentesis|"Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis~Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure."|3 years|||events|||Number
73065|NCT01077050|Secondary|Sensitivity and Specificity|"Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.~Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)~Negative Reference Diagnosis: All other skin lesions."|Post data lock||08/2013||||
73066|NCT01077050|Primary|SciBase Sensitivity and Specificity|"This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:~Sensitivity ≥ 0.90 to detect Melanoma~Sensitivity – (1-Specificity) > 0.00~Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma."|Post data lock|Biopsied Skin Lesions||Percentage of total lesions|Participants|95% Confidence Interval|Mean
73067|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|6 month visit|||percentage of participants|||Number
73068|NCT01077024|Secondary|Stimulant-free Results at 6-month Visit|At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|6 - months follow-up visit|This outcome was only compared for participants who attended the 6-month follow-up visit (n=210 and n=218, respectively).||percentage of participants|||Number
73069|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|3- month follow-up visits|||percentage of participants|||Number
73070|NCT01077024|Secondary|Stimulant-free Results at 3-month Visit|At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|3-month follow-up visit|This outcome was only compared for participants who attended the 3-month follow-up visit (n=226 and n=240, respectively).||percentage of participants|||Number
73071|NCT01077024|Secondary|Four Week Continuous Smoking Abstinence|A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 – 42.|Post-quit days 15-42|||percentage of participants|||Number
73072|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome)|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|Week 10 assessment|||percentage of participants|||Number
73073|NCT01077024|Primary|Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens|Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free.|Week 16|||percentage of weeks|||Number
73074|NCT01076985|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|"The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During pregnancy and for one year after birth|All available observed data for all participants and their resulting infants/live births are included.||participants|||Number
73075|NCT01076972|Primary|Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents|Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).|Baseline (Month 0) and following last treatment dose during the course of the survey period|Available data for all patients were included.||participants|||Number
73076|NCT01076972|Primary|Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit|Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.||copies/mL||Standard Deviation|Mean
73077|NCT01076972|Primary|Cluster of Differentiation 4 Lymphocyte Count (CD4)|The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline or treatment data were missing for a given visit were excluded from the analysis for that visit.||cells per cubic millimeter||Standard Deviation|Mean
73078|NCT01076972|Primary|Total Number of Patients With Adverse Drug Reactions|"Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During the course of the survey period up to Year 8|Available data for all patients were included.||participants|||Number
73093|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part II has 13 items focusing on activities of daily living including walking, writing, dressing and speech. A summary score ranging from 0 to 52 is generated by adding the 13 items. The higher score indicates worse condition.|Baseline and 24 months|||units on a scale||Standard Deviation|Mean
73079|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||Percentage of Patients|||Number
73080|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 12|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||percentage of patients|||Number
73081|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 4|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||Percentage of patients|||Number
73082|NCT01076959|Secondary|Physicians' Overall Effectiveness Response Rating|"Physicians' rated the level of overall patient improvement as markedly improved, improved, not changed, or not assessable by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions."|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.||Percentage of Patients|||Number
73083|NCT01076959|Primary|Total Number of Patients With Adverse Events|Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.|Baseline to Week 24|The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.||Percentage of Patients|||Number
73084|NCT01076686|Primary|Number of Subjects With Breast Implant Rupture|Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty|12 to 24 months post surgery|||participants|||Number
73085|NCT01076647|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
73086|NCT01076647|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
73087|NCT01076504|Secondary|Toxicity/Safety|Grade 3/4 toxicities|36 months|All enrolled and treated patients||participants|||Number
73088|NCT01076504|Secondary|Overall Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|84 months|All enrolled and treated patients||months||95% Confidence Interval|Median
73089|NCT01076504|Secondary|Time to Progression|Time to progression will be defined as the time from first treatment until objective tumor progression (PD). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 months|Includes all enrolled and treated patients||weeks||Full Range|Median
73090|NCT01076504|Secondary|Objective Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|36 months|Includes all patients who were treated and evaluated for response (74 patients - 6 were deemed not evaluable)||percentage of evaluable participants|||Number
73091|NCT01076504|Primary|1-year Survival|Percentage of patients still alive one year after their first treatment|12 months|All enrolled and treated patients||percentage of participants||95% Confidence Interval|Number
73092|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part IV includes four categories (11 items) related to dyskinesias, clinical fluctuations of symptoms, and other complications. A summary score ranging from 0 to 23 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months|||units on a scale||Standard Deviation|Mean
73126|NCT01076075|Primary|Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54||Week 0 to Week 54|The All Patients as Treated Population took at least one dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Adverse events include those that occurred prior to a receiving rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.||participants|||Number
73094|NCT01076452|Primary|The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication.|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson’s Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The higher score indicates the worse motor function.|Baseline and 24 months|||units on a scale||95% Confidence Interval|Mean
73095|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part I has four items assessing intellectual impairment, thought disorder, depression and motivation. A summary score ranging from 0 to16 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months|||units on a scale||Standard Deviation|Mean
73096|NCT01076361|Primary|Survival Probability of the Model 4968 Lead Based on Lead-related Complications|The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.|The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.|22 Model 4968s (in 21 participants) was not available for analysis||percentage of Model 4968 Leads|Participants|95% Confidence Interval|Number
73097|NCT01076348|Primary|Model 4965 Complication Free Rate|A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.|1 year|Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead.||Model 4965 complication free rate|Participants|95% Confidence Interval|Number
73098|NCT01076335|Primary|Number of Participants Progression Free at 1 Year|Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml − 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.|1 Year|One participant of 40 enrolled declined presurgical therapy after enrollment and was excluded from analysis.||participants|||Number
73099|NCT01076296|Primary|Percentage of Correct Diagnosis|A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.|2 years|||percentage of correct diagnosis||95% Confidence Interval|Number
73100|NCT01076283|Primary|Alcohol Drinking|"Whether baclofen, as compared to active placebo, results in lower quantity of alcohol consumed during the Alcohol Self-Administration (ASA).~Consistent with O'Malley et al. 2002, the ASA paradigm allows to use a fixed-dose (the priming drink), followed by a 2-hour “free-choice” phase when subjects may choose to drink or not up to 8 mini-drinks. Participants receive a monetary compensation of $3 dollars per each mini-drink not consumed; therefore the amount of minidrinks consumed during the 2-hour sessions ranges 0-8, and the monetary compensation ranges $0-24. The quantity of alcohol consumed during the free-choice session is expressed as standard drinking unit, where a standard drink unit contains about 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons)."|approximately 8 days after drug administration|||standard drinking units||Standard Deviation|Mean
73101|NCT01076283|Primary|Alcohol Urge|"Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Urge Questionnaire (AUQ)] during the Cue Reactivity.~The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent’s feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from strongly disagree to strongly agree. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by summing the item scores and ranges from 8 (lowest craving value) to 56 (highest craving value). Higher scores reflect greater craving (i.e. worse outcome)."|approximately 8 days after drug administration|||units on a scale||Standard Deviation|Mean
73102|NCT01076244|Secondary|Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).|For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.|Baseline and month 6|All available patients at the month 6 reporting period were analyzed.||units on a scale||95% Confidence Interval|Mean
73103|NCT01076244|Primary|Pain as Measured by Visual Analog Scale (VAS).|A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and six months|all available patients reporting at Month 6||units on a scale||95% Confidence Interval|Mean
73114|NCT01076192|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
73104|NCT01076244|Secondary|Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).|As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.|Baseline and month 6|All patients having a month six report report were analyzed.||units on a scale||95% Confidence Interval|Mean
73105|NCT01076244|Secondary|Improvement in Functional Mobility|Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.|baseline and month 6|All available patients at six months were analyzed.||units on a scale||95% Confidence Interval|Mean
73106|NCT01076192|Secondary|Number of Participants With Serious Adverse Events (SAEs)|"SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion.~See the Reported Adverse Events Section for more details."|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.||participants|||Number
73107|NCT01076192|Primary|Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)|The PGA was used to measure participants’ disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
73108|NCT01076192|Primary|Mean Change From Baseline in Body Surface Area (BSA) Affected|Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of body surface area||Standard Deviation|Mean
73109|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
73110|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
73111|NCT01076192|Secondary|Number of Participants With Adverse Events of Special Interest (AESIs)|AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.||participants|||Number
73112|NCT01076192|Secondary|Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.||units on a scale (a derived score)||Standard Deviation|Mean
73113|NCT01076192|Secondary|Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.||units on a scale||Standard Deviation|Mean
73115|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
73116|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.||percentage of participants|||Number
73117|NCT01076192|Primary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included all participants who received at least 1 dose of adalimumab and had at least one follow-up visit (ITT) with evaluable data.||units on a scale||Standard Deviation|Mean
73118|NCT01076166|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.||Participants|||Number
73119|NCT01076166|Primary|Average Time From Baseline to Recovery From Fever and Other Symptoms|Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients.||Days||Standard Deviation|Mean
73120|NCT01076153|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.||Events|||Number
73121|NCT01076153|Primary|Average Time From Baseline to Recovery From Cough and Other Symptoms|Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|The per-protocol population consisted of 694 participants as 66 participants were excluded for protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).||Days||Standard Deviation|Mean
73122|NCT01076088|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for FPG. Last observation carried forward (missing data approach).||mg/dL||95% Confidence Interval|Least Squares Mean
73123|NCT01076088|Secondary|Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24|Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for 2-h PMG subsequent to at least 1 dose of study treatment, or lacked baseline data for 2-h PMG. Last observation carried forward (missing data approach).||mg/dL||95% Confidence Interval|Least Squares Mean
73124|NCT01076088|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
73125|NCT01076075|Primary|Number of Participants Discontinuing Study Drug Due to An Adverse Event||Week 0 to Week 54|The All Patients as Treated Population took at least 1 dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Participants discontinued due to adverse events are reported regardless of rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.||participants|||Number
73127|NCT01076075|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value.|Baseline to Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.||mg/dL||95% Confidence Interval|Least Squares Mean
73128|NCT01076075|Secondary|Change From Baseline in 2-hour Post-Meal Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.||mg/dL||95% Confidence Interval|Least Squares Mean
73129|NCT01076075|Primary|Change From Baseline in Hemoglobin A1C (%) at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
73130|NCT01076036|Primary|Procedural Technical Success|Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.|Intervention|Total number of PCI devices.||percentage of PCI devices|||Number
73131|NCT01076036|Primary|Clinical Procedural Success|The percentage of Participants with <30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)|48-hrs or hospital discharge, whichever occurs first|||percentage of participants|||Number
73132|NCT01075984|Primary|Steady State Apparent Total Body Clearance of Oral Posaconazole (CL/F)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|CL/F for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter|||||
73133|NCT01075984|Primary|Steady State Average Concentration of Oral Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (12 hours).|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
73134|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of Oral Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
73135|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of Oral Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||Hours||Full Range|Median
73136|NCT01075984|Primary|Steady State Maximum Concentration of Oral Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
73137|NCT01075984|Primary|Steady State Trough Concentration of Oral Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
73138|NCT01075984|Primary|Steady State Total Body Clearance of IV Posaconazole (CL)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|CL for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter.|||||
73139|NCT01075984|Primary|Steady State Average Concentration of IV Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (24 hours).|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||ng/mL||Standard Deviation|Mean
73140|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||hour*ng/mL||Standard Deviation|Mean
73156|NCT01075958|Primary|Four Choice Reaction Time (Attention)|A visual representation of the four direction arrow keys of a standard keyboard was presented on screen. The arrows ‘lit up’ at random on screen until the corresponding key press was made. In all, each arrow was the target stimulus 12 times, forming a total of 48 stimuli for this task in all.|Single visit|||ms||Standard Error|Mean
73141|NCT01075984|Primary|Single Dose Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||hour*ng/mL||Standard Deviation|Mean
73142|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||Hours||Full Range|Median
73143|NCT01075984|Primary|Single Dose Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0 and 1)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||Hours||Full Range|Median
73144|NCT01075984|Primary|Steady State Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||ng/mL||Standard Deviation|Mean
73145|NCT01075984|Primary|Single Dose Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
73146|NCT01075984|Primary|Steady State Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.||ng/mL||Standard Deviation|Mean
73147|NCT01075984|Primary|Single Dose Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.||ng/mL||Standard Deviation|Mean
73148|NCT01075971|Primary|The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy.|"Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from Not at all satisfied (score = 0) to Totally satisfied (score = 10)."|Daily, Day 1 to Day 5|||Score on a scale||Standard Deviation|Mean
73149|NCT01075958|Primary|Word Recognition (Episodic Memory)|The original 15 words plus 15 distractor words were presented one at a time in a random order. For each word the participant indicated whether or not it was included in the original list of words by pressing appropriate ‘yes’ and ‘no’ keys as quickly as possible. Stimuli remained on screen until an appropriate response had been made.|Single visit|||percent of correct responses||Standard Error|Mean
73150|NCT01075958|Primary|Delayed Word Recall (Episodic Memory)|The participant was again given 60 seconds to write down as many of the words presented previously as possible.|Single visit|||Number of words recalled||Standard Error|Mean
73151|NCT01075958|Primary|Immediate Word Recall (Episodic Memory)|A unique set of fifteen words is presented. Words were selected at random from a large bank of words derived from the MRC Psycholinguistic Database matched for word length, frequency, familiarity and concreteness. Stimulus duration was one second, as was the inter-stimulus duration. Following word presentation, the participant was allowed 60 seconds to write down as many of the words as possible.|Single visit|||Number of words recalled||Standard Error|Mean
73152|NCT01075958|Primary|3-back Task (Working Memory)|A continuous string of letters (upper and lower case; inter-stimulus interval of 2.5 seconds) was presented; 45 letters in total with 15 target pairs. For each stimulus, participants were instructed to indicate whether this was the same letter that appeared three letters before.|Single visit|||percent of correct responses||Standard Error|Mean
73153|NCT01075958|Primary|Corsi Blocks Span (Spatial Working Memory)|In this task nine identical blue squares appeared on screen in non-overlapping random positions. A set number of blocks changed colour from blue to red in a randomly generated sequence. Participants were instructed to repeat the sequence by clicking on the blocks using the mouse and cursor. The task was repeated five times at each level of difficulty. The sequence span increased from 4, until the participant could no longer correctly recall the sequence, resulting in a span measure of nonverbal working memory, calculated by averaging the level of the last five correctly completed trials.|Single visit|||Blocks remembered in sequence||Standard Error|Mean
73154|NCT01075958|Primary|Alphabetic Working Memory (Working Memory)|Five random letters (A-Z) were presented sequentially for the participant to hold in memory. This was followed by a series of 30 probe digits (15 targets and 15 distractors) for each of which the participant indicated whether or not it had been in the original series by a simple key press. The task consisted of 3 separate trials.|Single visit|||percent of correct responses||Standard Error|Mean
73155|NCT01075958|Primary|Numeric Working Memory (Working Memory)||Single visit|||percent of correct responses||Standard Error|Mean
73157|NCT01075958|Primary|Choice Reaction Time (Attention)|An arrow appeared on the screen pointing to the left or to the right. Participants responded with a left or right key press corresponding to the direction of the arrow. There was a randomly varying inter-stimulus interval of between 1 and 3 seconds for a total of fifty stimuli.|Single visit|||ms||Standard Error|Mean
73158|NCT01075958|Secondary|Depression, Anxiety and Stress Scale (DASS)|The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Subjects are asked to use 4-point (0-3) severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress (0-42) are calculated by summing the scores for the relevant items, with higher scores indicating higher incidence of negative emotional symptoms. A total score can be derived by adding scores from each of the subscales (0-126).|Single visit-90 minutes|||Scores on a scale||Standard Deviation|Mean
73159|NCT01075958|Primary|Simple Reaction Time (Attention)|The participant was instructed to press the ‘space bar’ on the laptop keyboard as quickly as possible every time an upwards pointing arrow appeared on screen. Fifty stimuli were presented with an inter-stimulus duration that varied randomly between 1 and 3.5 seconds.|Single visit|Only those participants for whom a venous blood sample was obtained (N=239) were entered into the analysis. A further 20 participants were excluded on the basis that their BMI exceeded 30, and could not be considered 'healthy individuals'.||ms||Standard Error|Mean
73160|NCT01075815|Secondary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.||cycles|||Number
73161|NCT01075815|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
73162|NCT01075815|Secondary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.||participants|||Number
73163|NCT01075815|Secondary|Total Number of Births|Total number of births per reporting group was calculated.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents number of participants evaluated for this measure."||births|||Number
73164|NCT01075815|Secondary|Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||cycles|||Number
73165|NCT01075815|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met.|S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||Days||Standard Deviation|Mean
73166|NCT01075815|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants with plasma E2 levels at r-hCG day."||picogram/milliter (pg/mL)||Standard Deviation|Mean
73167|NCT01075815|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)||2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||IU||Standard Deviation|Mean
73168|NCT01075815|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
73169|NCT01075815|Secondary|Number of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||participants|||Number
73170|NCT01075815|Secondary|Number and Quality of Embryos|Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants who had at least one fertilized oocyte."||embyros|||Number
73171|NCT01075815|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||2PN oocytes|||Number
73172|NCT01075815|Secondary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||mature oocytes|||Number
73173|NCT01075815|Secondary|Mean Number of Oocytes Retrieved|Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||oocytes||Standard Deviation|Mean
73174|NCT01075815|Secondary|Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.||follicles||Standard Deviation|Mean
73175|NCT01075815|Primary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.|Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])|Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication.||sacs per embryo||Standard Deviation|Mean
73176|NCT01075763|Secondary|Global Deterioration Scale Score|Global deterioration scale includes seven different diagnostic stages ranging between “no cognitive deterioration” and “very serious cognitive deterioration”. It investigates the cognitive impairment. Scores range between 1 (no cognitive deterioration) and 7 (very severe cognitive decline).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73177|NCT01075763|Secondary|Geriatric Depression Scale (GDS) Score|The GDS consists of 30 'yes' or 'no' items aimed to assess depression. One point is assigned to each answer and the cumulative score is rated on a scoring grid. Scores are grouped as follows: 0-9 'normal', 10-19 'mildly depressed', and 20-30 'severely depressed'.|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73178|NCT01075763|Secondary|Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score|CIBIC-PLUS: structured instrument based on comprehensive evaluation of 3 domains: participant cognition, behavior and functioning, including assessment of daily living activities. It includes 15 items and represents assessment of skilled clinician using validated scales based on the observation at interviews conducted separately with participant and caregiver familiar with behavior of participant. According to comparison between baseline and follow-up assessments, scores can range between 1 (markedly improved) and 7 (markedly worsened), with 4 indicating no change observed between two visits.|Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||participants|||Number
73179|NCT01075763|Secondary|Physical Self-Maintenance Scale (PSMS) Score|PSMS designed as a disability measure for use in planning and evaluating treatment in elderly participants living in community or in institutions, is Guttman scale containing 6 items of self-care. The scale is based on theory that human behavior can be ordered in a hierarchy of complexity, within each category, a further hierarchy of complexity runs from basic to complex activities. It includes 6 items, testing the following areas: toilet use, eating, dressing, physical appearance, deambulation and bath. Scores range between 0 (excellent performance) and 30 (worst performance).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73180|NCT01075763|Secondary|Instrumental Activities of Daily Living (IADL) Score|IADL is used to evaluate participants with early-stage disease, both to assess level of disease and to determine participant's ability of self-care. IADL scale measures functional impact of emotional, cognitive, and physical impairments. It provides information about participants' compromising rate and care he might need. It includes 8 items: testing ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medication and ability to handle finances. Scores range between 0 (impairment) and 8 (full independence).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73181|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score|ADAS-NonCog is a subscale of ADAS aimed to evaluate the non-cognitive features such as mood state and behavioral changes. It takes about 10 minutes to be performed and includes 10 items: testing tearful, depressed mood, concentration/distractibility, uncooperative to testing, delusions, hallucinations, pacing, motor activity increase, tremors and appetite change. Scores range between 0 (excellent performance) and 35 (worst performance).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73182|NCT01075763|Secondary|Mini Mental Status Examination (MMSE) Score|MMSE is a tool for screening cognitive decline associated with dementia. It is a brief examination intended to evaluate an adult participant's level of cognitive functioning. The test is performed in following areas: orientation in time and place, learning and immediate recall, mental control and concentration, short-term recall, naming ability, language expression, verbal comprehension, writing comprehension, writing ability and visual-spatial coordination. Scores range between 0 (maximum cognitive deficit) and 30 (no cognitive deficit).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73356|NCT01074450|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
73183|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Week 12 and 28|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73184|NCT01075763|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Baseline and Week 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.||units on a scale||Standard Deviation|Mean
73185|NCT01075685|Secondary|Change in the Number of Excessive Drinkers|The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week|baseline and 6 weeks|||participants|||Number
73186|NCT01075685|Secondary|Category of Change in Weekly Alcohol Intake|"Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are:~clinically significant reduction in WAI, defined as a decrease of 10% or over;~clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0);~and no clinically significant change, which includes all other cases."|baseline and 6 weeks|||participants|||Number
73187|NCT01075685|Secondary|Relative Change in Weekly Alcohol Intake|(6 weeks minus baseline)/baseline|baseline and 6 weeks|Participants with weekly alcohol consumption baseline at 0 were excluded from this analysis||percent of baseline consumption||Standard Deviation|Mean
73188|NCT01075685|Primary|Change in Weekly Alcohol Intake|"The unit of standard drink is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks."|baseline and 6 weeks|Only participants who completed the study were included in this analysis||standard drinks||Standard Deviation|Mean
73189|NCT01075646|Secondary|Contamination of the Catheter (Microbiologist Analysis)||at 48 hours|||participants|||Number
73190|NCT01075646|Secondary|Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)||During 8-15 days|||participants|||Number
73191|NCT01075646|Secondary|Secondary Effects Due to Morphine: Nausea and Vomiting||during 48 hours|||participants|||Number
73192|NCT01075646|Secondary|Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.||7 Days (from Day 8-15)|||hours||Inter-Quartile Range|Median
73193|NCT01075646|Secondary|Intensity of Pain Measured by Verbal Pain Scale.|Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate tje àom that feel with a number from 0 to 10.|At interval periods during 48 hours|||units on a scale||Inter-Quartile Range|Median
73194|NCT01075646|Primary|Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System||48 hours|||mg||Inter-Quartile Range|Median
73195|NCT01075399|Primary|Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors|Primary tumor uptake of [F 18]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.|Time between 1st and 2nd scan was 1 to 6 days|Based upon inclusion/exclusion criteria||participants|||Number
73196|NCT01075347|Secondary|Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)||every day till total re-epithelization up to 14 days|||participants|||Number
73197|NCT01075347|Primary|Patients With Corneal Epithelial Healing Time Within 14 Days|Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for >14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients.|every day till total re-epithelization up to 14 days|||participants|||Number
73198|NCT01075282|Secondary|Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 26, 52, 78, and 83 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.||participants|||Number
73215|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index|Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.||kilograms per square meter (kg/m^2)||Standard Error|Least Squares Mean
75779|NCT01048541|Primary|Mean Residual Urine Volume|Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation|3 catheterisations on 1 day|||mL||Standard Deviation|Mean
73199|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
73200|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
73201|NCT01075282|Secondary|Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.||milliliter of mercury (mmHG)||Standard Error|Least Squares Mean
73202|NCT01075282|Secondary|Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable sitting pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
73203|NCT01075282|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
73204|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin||Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picogram/milliliter||Standard Deviation|Mean
73205|NCT01075282|Secondary|Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
73206|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units/liter||Inter-Quartile Range|Median
73207|NCT01075282|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||participants|||Number
73208|NCT01075282|Secondary|Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||events per participant per year||Standard Deviation|Mean
73209|NCT01075282|Secondary|Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.||events|||Number
73210|NCT01075282|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. The number of participants with at least 1 TEAE is reported.||participants|||Number
73211|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
73212|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
73213|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living|The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = “not at all difficult” and 1 = “unable to do”. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
73214|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
73357|NCT01074450|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
73216|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilogram (kg)||Standard Error|Least Squares Mean
73217|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Glucagon Concentration|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable glucagon data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
73218|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
73219|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMBG data. Only pre-rescue measurements were used.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
73220|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||participants|||Number
73221|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||participants|||Number
73222|NCT01075282|Secondary|Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percent||Standard Error|Least Squares Mean
73223|NCT01075282|Primary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
73224|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73358|NCT01074437|Primary|Lesion Regression|measure of change in lesion area or volume|12 months|Insufficient enrollment for data analysis to be meaningful.|||||
73225|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73226|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73227|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73228|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73229|NCT01075256|Primary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73230|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73231|NCT01075256|Primary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.||Units on a scale||95% Confidence Interval|Mean
73232|NCT01075243|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
73248|NCT01075217|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.||participants|||Number
73263|NCT01075204|Secondary|Factors Affecting the Speed of Recovery|Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.|10 days|All enrolled patients||coefficient|||Number
73233|NCT01075243|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73234|NCT01075243|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73235|NCT01075243|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73236|NCT01075243|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73237|NCT01075243|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73238|NCT01075243|Secondary|Total Pain Relief Score (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73249|NCT01075217|Secondary|The Number of Participants With Significant Motion Artifacts (Scores of 3 or 4) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable. Scores of 3 and 4 were counted as significant motion artifacts.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Patients with significant motion artifact were those with a score of 3 or 4 for motion artifacts in vessels distal to the knee||participants|||Number
73359|NCT01074437|Secondary|Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner.||1, 2 and 6 months after treatment initiation||||||
73239|NCT01075243|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73240|NCT01075243|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 2 hours post dose|All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Score on a scale||Standard Deviation|Mean
73241|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 6 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Percentage of participants|||Number
73242|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 2 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||Percentage of participants|||Number
73243|NCT01075243|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.||minutes||Full Range|Median
73244|NCT01075243|Secondary|Time to Onset of Meaningful Pain Relief|Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
73245|NCT01075243|Secondary|Time to Confirmed First Perceptible Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.||minutes||Standard Deviation|Mean
73246|NCT01075243|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from Baseline to 6 hours post dose|Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment.||Score on a scale||Standard Deviation|Mean
73247|NCT01075217|Secondary|The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The Investigator assessed all study images obtained for each patient using a 2-point scale (1 = adequate quality; 2 = inadequate quality); assessment was independent of factors or problems relating to the underlying patient condition or the imaging parameters selected.~Results are provided for patients with adequate quality."|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.||participants|||Number
73360|NCT01074437|Secondary|Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.||1, 2 and 6 months after treatment initiation||||||
73250|NCT01075217|Secondary|Level of Heat in the Lower Extremities Scored by Group 2 as Assessed on the Heat VAS Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Heat VAS was completed by the Group 2 patients to assess his/her heat level (separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no heat and the right end (10 cm) of the scale indicating the worst heat.~The Heat VAS was completed by the patient before completing the Pain VAS to assess pain."|Immediately after administration of agent using a power injector for the administration|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Group 2 patients provided an assessment of heat by the Heat VAS prior to assessing pain by the Pain VAS.||centimeters||Standard Deviation|Mean
73251|NCT01075217|Primary|Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Pain VAS was completed by the Group 1 patients to assess his/her pain level (not scoring heat separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.~The 10-centimeter Pain VAS (excluding Heat assessment, which was separately assessed) was completed by the Group 2 patients to assess his/her pain level in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.~Group 1 completed the Pain VAS (heat not separate from pain). Group 2 completed the Pain VAS for pain only and, separately, the Heat VAS for heat only."|immediately after administration of agent using a power injector for the administration|Patients who received study agent, had the corresponding endpoint evaluations available and had no deviations from the planned protocol were included in the analysis.||centimeters||Standard Deviation|Mean
73252|NCT01075204|Secondary|Percentage of Participants Compliant With Treatment|Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.|10 days|All enrolled patients.||percentage of participants|||Number
73253|NCT01075204|Secondary|Post-nasal Discharge Status at End of Study|Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.|10 days|Enrolled patients with post-nasal discharge data available.||participants|||Number
73254|NCT01075204|Secondary|Rhinorrhea Status at End of Study|Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.|10 days|All enrolled patients||participants|||Number
73255|NCT01075204|Secondary|Abnormal Breathing Sounds Status at End of Study|Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.|10 days|All enrolled patients||participants|||Number
73256|NCT01075204|Secondary|Dyspnea Status at End of Study|Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.|10 days|All enrolled patients||participants|||Number
73257|NCT01075204|Secondary|Sputum Status at End of Study|Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.|10 days|Enrolled patients with sputum data available.||participants|||Number
73258|NCT01075204|Secondary|Cough Status at End of Study|Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.|10 days|Enrolled patients with cough data available.||participants|||Number
73259|NCT01075204|Secondary|Fever Status at End of Study|Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.|10 days|All enrolled patients||participants|||Number
73260|NCT01075204|Primary|Classification of Overall Response|"Based on the participant and physician's assessment, overall symptom response was classified as follows:~Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment.~Slow Responders: participants showing clinical recovery between Day 6 & Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms).~Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms)."|10 days|All enrolled patients||participants|||Number
73261|NCT01075204|Primary|Percentage of Participants With Clinical Success|Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.|10 days|All enrolled patients.||percentage of participants||95% Confidence Interval|Number
73262|NCT01075204|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.~If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE):~Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.~Please see Adverse Events section below for more details."|10 days|All enrolled patients.||participants|||Number
73334|NCT01074931|Secondary|The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment|As so few participants withdrew from lopinavir/ritonavir treatment, durations of lopinavir/ritonavir therapy required for 25 percent, 50 percent and 75 percent of participants could not be established. The numbers of participants in each subgroup who discontinued from treatment due to an adverse event are presented.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.||Participants|||Number
73264|NCT01075204|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.~Participants with treatment failure were further categorized as:~All symptoms improved but not resolved within the study period;~Some symptoms improved and some resolved;~Some symptoms resolved or improved while other symptoms did not improve (unchanged);~Some symptoms resolved or improved while other symptoms became worse."|10 days|All enrolled patients||percentage of participants|||Number
73265|NCT01075204|Primary|Percentage of Participants With a Fast Recovery|"Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment.~Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom."|Day 1 to Day 5|All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data.||percentage of participants|||Number
73266|NCT01075191|Secondary|Change From Baseline in CD4/CD8 T-cell Ratio|The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||ratio||Standard Deviation|Mean
73267|NCT01075191|Secondary|Change From Baseline in Relative CD8 Cell Count|Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||percentage of cells||Standard Deviation|Mean
73268|NCT01075191|Secondary|Change From Baseline in Absolute CD8 Cell Count|Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||cells/µL||Standard Deviation|Mean
73269|NCT01075191|Secondary|Change From Baseline in Relative CD4 Cell Count|Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||percentage of cells||Standard Deviation|Mean
73270|NCT01075191|Secondary|Change From Baseline in Absolute CD4 Cell Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||cells/µL||Standard Deviation|Mean
73271|NCT01075191|Primary|Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL|Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.||percentage of participants|||Number
73272|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death|The number of subjects who died|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
73273|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia|The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
73274|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.|The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
73275|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death|The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.||participants|||Number
73276|NCT01075152|Other Pre-specified|Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26|Percentage of Participants who died by week 26 based on CSF white blood cell (WBC) count at study entry (time of randomization at a median of 8 days of anti-fungal therapy).|26 weeks|among persons with a measured CSF white cell count at randomization (Day 7-11 of amphotericin treatment)||percentage of participants|||Number
73277|NCT01075152|Secondary|Microbiologic Clearance|Microbiologic clearance of cryptococcus as measured by serial quantitative cryptococcal cultures collected at diagnosis through 14 days of amphotericin therapy. The early fungicidal activity (EFA) of the rate of clearance is expressed as log10 colony forming units (CFU) of Cryptococcus neoformans per mL of CSF per day.|4 weeks|All participants with >2 quantitative CSF cultures obtained||log10 CFU/mL/day||95% Confidence Interval|Mean
73278|NCT01075152|Secondary|Karnofsky Functional Status|"Functional status via Karnofsky performance status score at 4, 26, 46 weeks.~Karnofsky Scale:~100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment necessary.~10 - Moribund; fatal processes progressing rapidly. 0 - Dead"|46 weeks|Analysis is of persons alive at the time point.||Scores on a scale||Standard Deviation|Mean
73279|NCT01075152|Secondary|Antiretroviral Therapy Tolerability|Incidence of antiretroviral therapy interruption by >=3 consecutive days|26 weeks|Analysis is of persons who survived to initiate HIV therapy.||participants|||Number
73280|NCT01075152|Secondary|HIV-1 Viral Suppression|HIV-1 virologic suppression to <400 copies/mL at 26-weeks after enrollment|26 weeks|Among persons alive at 26 weeks. 1 participant in the early ART arm had consent withdrawn by their family on day 2 after study entry. 3 participants in the deferred ART arm missing their 26 week viral load sampling.||participants|||Number
73281|NCT01075152|Secondary|46-week Survival|46-week survival by time-to-event analysis of all subjects enrolled|46 weeks|||participants|||Number
73282|NCT01075152|Secondary|Safety of ART Initiation|Incidence of Adverse Events (Grade 3,4,5) through 46-weeks, as defined by the National Institute of Allergy and Infectious Diseases, Division of AIDS toxicity classification scale, version 2009.|46 weeks|||participants|||Number
73283|NCT01075152|Secondary|Incidence of Cryptococcal-relapse|Incidence of culture positive cryptococcal meningitis relapse|46 weeks|||participants|||Number
73284|NCT01075152|Secondary|Incidence of Immune Reconstitution Inflammatory Syndrome|Incidence of cryptococcal-related immune reconstitution inflammatory syndrome through 46 weeks after enrollment.|46 weeks|analysis is of persons who survived to initiate HIV therapy||participants|||Number
73285|NCT01075152|Primary|Mortality|Intention to treat analysis of 26 week survival of all subjects enrolled. Reported below are the numbers of participants who died by Week 26.|26 weeks from study entry|||participants|||Number
73286|NCT01075100|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|30 months|Patients who achieved CR or PR.||months||Full Range|Median
73287|NCT01075100|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|24 months|Patients who achieve a major objective response (CR or PR).||months||Full Range|Median
73288|NCT01075100|Secondary|Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|24 months|ITT population||months||95% Confidence Interval|Median
73289|NCT01075100|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|24 months|ITT population||months||95% Confidence Interval|Median
73290|NCT01075100|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months|24 months|Evaluable population||percentage of participants||95% Confidence Interval|Number
73291|NCT01075100|Primary|Objective Response Rate (ORR)|"Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 months|Evaluable population||percentage of participants||95% Confidence Interval|Number
73292|NCT01075087|Secondary|24 Hour Total Opioid Consumption.|24 Hour total opioid consumption translated into IV morphine equivalents.|24 hours|||miligram IV morphine equivalents||Inter-Quartile Range|Median
73293|NCT01075087|Primary|Quality of Recovery 40 Score|Quality of Recovery 40 Score at 24 hours postoperative.|24 hours post operatively|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
73294|NCT01075074|Secondary|Time to Hospital Discharge Readiness|Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge.|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||minutes||Inter-Quartile Range|Median
73295|NCT01075074|Secondary|Opioid Pain Medications Consumed During the First 24 Hours Post Surgery|Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||mEq of PO morphine equivalent||Full Range|Mean
73296|NCT01075074|Secondary|Pain Burden During Early Recovery From Anesthesia|Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable.|Post Operative|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||score on a scale * minutes||Inter-Quartile Range|Median
73361|NCT01074437|Secondary|Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.||1, 2, and 6 months after treatment initiation||||||
73297|NCT01075074|Primary|The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery|The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.|24 hours after surgery|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.||units on a scale||Full Range|Median
73298|NCT01074944|Secondary|LTTP: Mean Biomarker (MIP1-beta) Value at Baseline, 1 Year, and 2 Years|MIP1-beta biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||pg/mL||Standard Deviation|Mean
73299|NCT01074944|Secondary|LTTP: Mean Biomarker (GL-1 on DBS) Value at Baseline, 1 Year, and 2 Years|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||mcg/mL||Standard Deviation|Mean
73300|NCT01074944|Secondary|LTTP: Mean Biomarker (Chitotriosidase) Value at Baseline, 1 Year, and 2 Years|Chitotriosidase biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||nmol/hr/mL||Standard Deviation|Mean
73301|NCT01074944|Secondary|LTTP: Total Bone Marrow Burden Score (BMB) at Baseline, 1 Year, and 2 Years|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||BMB Score||Standard Deviation|Mean
73302|NCT01074944|Secondary|LTTP: Total Z-scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||Z-score||Standard Deviation|Mean
73303|NCT01074944|Secondary|LTTP: Total T-Scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||T-score||Standard Deviation|Mean
73304|NCT01074944|Secondary|LTTP: Bone Mineral Density (BMD) at Baseline, 1 Year, and 2 Years|BMD measurements of the spine and bilateral femur were acquired by DXA scan.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||g/cm^2||Standard Deviation|Mean
73305|NCT01074944|Secondary|LTTP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, 1 Year, and 2 Years|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||participants|||Number
73306|NCT01074944|Secondary|LTTP: Number of Participants With Bone Crises Assessment at Baseline, 1 Year and 2 Years|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crises, 1= 1 bone crisis during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||participants|||Number
73307|NCT01074944|Secondary|LTTP: Number of Participants With Mobility Status (MS) at Baseline, 1 Year and 2 Years|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.||participants|||Number
73308|NCT01074944|Secondary|LTTP: Percentage of Participants Who Maintained a Stable Bone Criterion ,Hemoglobin Level, Platelet Count, Liver Volume and Spleen Volume at 1 Year and 2 Years|Participant were considered as stable if they met the following criteria: hemoglobin level did not decrease >1.5 g/dL from baseline for PAP, platelet count does not decrease >25% below Baseline for PAP, liver volume does not increase >20% above Baseline for PAP, spleen volume does not increase >25% above Baseline for PAP. Baseline for PAP was defined as last available assessment prior to randomization.|1 Year, 2 Years|Analysis was performed on intent to treat (ITT) population which included all participants who received at least 1 dose of eliglustat after randomization. Here ‘n’ signifies number of participants with available data at specified time points.||percentage of participants||95% Confidence Interval|Number
73309|NCT01074944|Secondary|LIP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26, 52 and 78|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different type of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.||participants|||Number
73351|NCT01074502|Primary|Proportion of Patients With a Success Rate (Based on the Researcher's Global Assessment (RGA) Sum of Clear (0) or Almost Clear (1))|RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.|16 weeks|small number of subjects to analyze||percentage of patients|||Number
73310|NCT01074944|Secondary|LIP: Number of Participants With Bone Crises Assessment at Baseline, Weeks 26, 52 and 78|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, 2= 2 bone crises, 6= 6 bone crises, and 24= 24 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.||participants|||Number
73311|NCT01074944|Secondary|LIP: Number of Participants With Mobility Status (MS) at Baseline, Weeks 26, 52 and 78|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.||participants|||Number
73312|NCT01074944|Secondary|LIP: Mean Biomarker (MIP1-beta) Value at Baseline, Week 78|MIP1-beta biomarker was assayed from plasma.|Baseline and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||pg/mL||Standard Deviation|Mean
73313|NCT01074944|Secondary|LIP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26, Week 52, and Week 78|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||mcg/mL||Standard Deviation|Mean
73314|NCT01074944|Secondary|LIP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26, 52, and 78|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||nmol/hr/mL||Standard Deviation|Mean
73315|NCT01074944|Secondary|LIP: Mean Spleen Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.||MN||Standard Deviation|Mean
73316|NCT01074944|Secondary|LIP: Mean Liver Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here, 'n' signifies number of participants with available data at specified time points.||MN||Standard Deviation|Mean
73317|NCT01074944|Secondary|LIP: Mean Platelet Count at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.||platelets*10^9 /L||Standard Deviation|Mean
73318|NCT01074944|Secondary|LIP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week, 52, and Week 78|Analysis was performed on all treated (AT) analysis set which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.||g/dL||Standard Deviation|Mean
73319|NCT01074944|Secondary|PAP: Total Bone Marrow Burden Score (BMB) at Baseline and Week 52|BMB Score was measured using magnetic resonance imaging (MRI), range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.||BMB Score||Standard Deviation|Mean
73320|NCT01074944|Secondary|PAP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26 and 52|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain during the past 4 weeks. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||participants|||Number
73321|NCT01074944|Secondary|PAP: Number of Participants With Bone Crises at Baseline, Weeks 26 and 52|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||participants|||Number
73352|NCT01074463|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
75780|NCT01048502|Secondary|Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.||baseline and 6-8 weeks|||pg/mL||Standard Deviation|Median
73322|NCT01074944|Secondary|PAP: Number of Participants With Mobility Status Asessments (MS) at Baseline, Weeks 26, and 52.|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||participants|||Number
73323|NCT01074944|Secondary|PAP: Total Z-scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively||Z-score||Standard Deviation|Mean
73324|NCT01074944|Secondary|PAP: Total T-Scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||T-score||Standard Deviation|Mean
73325|NCT01074944|Secondary|PAP: Bone Mineral Density (BMD) at Baseline and Week 52|BMD measurements of the spine and bilateral femur were acquired by dual-energy x-ray absorptiometry (DXA) scan.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.||g/cm^2||Standard Deviation|Mean
73326|NCT01074944|Secondary|PAP: Mean Biomarker Macrophage Inflammatory Protein-1 Beta (MIP1-beta) Value at Baseline, Weeks 26, 52|MIP1-beta biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.||pg/mL||Standard Deviation|Mean
73327|NCT01074944|Secondary|PAP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26 and Week 52|GL-1 on DBS biomarker was assayed from dried blood spot (DBS).|Baseline, Week 26 and week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||mcg/mL||Standard Deviation|Mean
73328|NCT01074944|Secondary|PAP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26 and Week 52|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population which all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.||nmol/hr/mL||Standard Deviation|Mean
73329|NCT01074944|Secondary|PAP: Mean Liver Volume at Baseline, Weeks 26, 52||Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||MN||Standard Deviation|Mean
73330|NCT01074944|Secondary|PAP: Mean Spleen Volume at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively.||MN||Standard Deviation|Mean
73331|NCT01074944|Secondary|PAP: Mean Platelet Count at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||platelets*10^9 /L||Standard Deviation|Mean
73332|NCT01074944|Secondary|PAP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26 and 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.||g/dL||Standard Deviation|Mean
73333|NCT01074944|Primary|PAP: Percentage of Participants Who Remained Stable for 52 Weeks During the PAP|Participants were considered as stable if they met all of the following criteria: 1) no more than 2 bone crisis during PAP (with no more than 1 bone crisis during either the first 6 months or the later 6 months of the period), and were free of other clinically symptomatic bone disease during the entire 52-week PAP; 2) hemoglobin level not decreased >1.5 g/dL from Baseline for PAP; 3) platelet count not decreased >25% from Baseline for PAP; 4) spleen volume (in multiples of normal [MN]) did not increase >25% from Baseline for PAP; 5) liver volume (in MN) did not increase >20% from Baseline for PAP. Baseline for PAP was defined as the last assessment prior to randomization.|PAP Baseline up to the end of PAP (Week 52)|Analysis was performed on per protocol (PP) population which included all participants who were at least 80% compliant with investigational medicinal product (IMP) dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.||percentage of participants||95% Confidence Interval|Number
73335|NCT01074931|Secondary|Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations|The types of adverse events reported are summarized. The presence of lipodystrophy (abnormal body fat distribution) and its location was to be recorded. However, due to an oversight, there was not a place to record the location of lipodystrophy on the case report form. Doctors used clinical judgment to rate lipodystrophy in treatment-experienced participants. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|The adverse event population includes all participants who took at least one dose of lopinavir/ritonavir (98). Lipodystrophy evaluations were performed in treatment-experienced participants (90), not treatment-naive participants (8).||Participants|||Number
73336|NCT01074931|Secondary|Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen|Visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The frequency with which each participant forgot to take their medication since the last visit and discontinuations of treatment and the reasons were documented at each visit and are summarized. The number of participants changing from lopinavir/ritonavir soft gel capsule to tablet are also presented. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month. Note: participants may have had multiple missed doses or therapy changes.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.||Participants|||Number
73337|NCT01074931|Primary|Evolution of the Tolerance Issues|At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants taking at least one dose of lopinavir/ritonavir.||Participants|||Number
73338|NCT01074931|Primary|Evolution of CD4 Count|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point.||cells per cmm||Standard Deviation|Mean
73339|NCT01074931|Primary|Evolution of the HIV Viral Response|The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.||participant|||Number
73340|NCT01074658|Secondary|Percentage of Participants With Procedural Success|Procedural success, defined as device success with absence of in-hospital MACCE|up to 30 days|All attempted population in which the separate variables related to procedural success (see outcome measure description) were analyzable.||percentage of participants|||Number
73341|NCT01074658|Secondary|Percentage of Participants With Device Success|"Device Success is defined as a composite of:~Successful device delivery;~Stable device placement;~Intact retrieval of delivery catheter;~Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation"|up to 24 hours|All attempted population in which the separate variables related to device success (see outcome measure description) were analyzable.||percentage of participants|||Number
73342|NCT01074658|Primary|Major Adverse Cardiac & Cerebrovascular Events (MACCE)|"MACCE is defined as a composite of:~All cause mortality~Myocardial Infarction (Q-wave and non-Q-wave)~Emergent cardiac surgery or percutaneous re-intervention~Stroke~The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days."|30 days|All attempted population.||Freedom from MACCE (%) @30days|||Number
73343|NCT01074554|Secondary|Change in Modified Sarcoidosis Activity and Severity Index (SASI) at Completion of Therapy.|Characterization of lesion severity was conducted using Modified Sarcoidosis Activity and Severity Index (SASI), measuring erythema, induration and desquamation. The modification was that the same scale was applied to any part of the body, instead of the face alone. The scale range is 0 (no problem) to 72 (very severe).|Baseline to 8 weeks|||units on a scale||Standard Deviation|Mean
73344|NCT01074554|Primary|Granuloma Burden|Number of patients with a decrease in Granuloma Burden (only in those patients having granulomas present at baseline biopsy)|Baseline to 8 weeks|||participants|||Number
73345|NCT01074554|Primary|Change in Lesion Size at the Completion of Antibiotic Therapy, Measured on a Continuous Scale; Change Will be Determined by Change in Diameter of the Lesions||Baseline to 8 weeks|||mm||Standard Deviation|Median
73346|NCT01074502|Primary|Proportion of Patients Achieving a Clear or Almost Clear PGA at 16 Weeks||16 weeks|||percentage of participants|||Number
73347|NCT01074502|Secondary|Safety of Apremilast 20 Mgs BID for 12 Weeks Will be Assessed by Evaluating Adverse Events (AEs), Vital Signs, Laboratory Evaluations and Withdrawals From the Study||16 weeks|||participants|||Number
73348|NCT01074502|Secondary|The Absolute Change in Lesion Counts (Total, Inflammatory, Non-inflammatory) From Baseline to Week 12||12 weeks|||number of lesions|||Number
73349|NCT01074502|Primary|Mean Percentage Reduction From Baseline in Individual Lesion Counts (Total, Inflammatory, Non-inflammatory) at Week 12||12 weeks|||percentage of lesions||Standard Deviation|Mean
73350|NCT01074502|Primary|Proportion of Patients With a Minimum 2-grade Improvement in the Researcher Global Assessment (RGA) From Baseline to Week 12.|RGA measures the severity of acne. The scale goes from 0 (better)to 4 (worse). Score can only be whole numbers, ordinal.|12 weeks|small number of subjects to be analyzed||participants|||Number
73363|NCT01074307|Secondary|Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26|Global assessment of CHF: The Investigator defined, graded, and recorded the participant’s symptoms and signs by using a 6-point CHF scale ranging from 0 (unassessable), 1 (worsened), 2 (no change), 3 (mildly improved), 4 (moderately improved) and 5 (markedly improved).|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Units on a scale||Standard Deviation|Mean
73364|NCT01074307|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 26|Safety analysis population included all the randomized participants who had at least one dose of the investigational product had post-dose safety data confirmed at least once by the Investigator.||Participants|||Number
73365|NCT01074307|Secondary|Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder||Baseline up to Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.||Participants|||Number
73366|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Size at Week 26|Left ventricle size was measured as systolic and diastolic Left Ventricular Internal Dimension (LVID). Diastolic dimension was measured of the left ventricle at the level of the chordae tendineae. The systolic dimension was measured as the smallest dimension between the left septal endocardium and the posterior wall endocardium during systole, whether or not the two walls were exactly apposed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Milliliter LVID||Standard Deviation|Mean
73367|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26|LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Percent LVEF||Standard Deviation|Mean
73368|NCT01074307|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26|6-minute Walking Test (6-MWT) distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Meter||Standard Deviation|Mean
73369|NCT01074307|Secondary|Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA)|New York Heart Association (NYHA) classification of heart failure: Class I: No limitation: ordinary physical exercise does not cause undue fatigue, dyspnea, or palpitations. Class II: Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations, or dyspnea. Class III: Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms. Class IV: Unable to carry out any physical activity without discomfort: symptoms of heart failure are present even at rest with increased discomfort with any physical activity.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.||Percentage of participants|||Number
73370|NCT01074307|Primary|Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26|B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. The percent change of NT-pro BNP was calculated according to the formula: N-terminal pro B-type natriuretic peptide (NT-proBNP) reduction ratio = 100*(Baseline NT-proBNP - Week 26 NT-proBNP)/Baseline NT-proBNP.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percent change||Standard Deviation|Mean
73371|NCT01074268|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Events/100 years of patient exposure|||Number
73383|NCT01074242|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis||Percent of participants|||Number
73783|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening|There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
73372|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
73373|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
73374|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
73375|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
73376|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.||mmol/L||Standard Deviation|Mean
73377|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.||mmol/L||Standard Deviation|Mean
73378|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 4 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
73379|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 5 subjects, all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
73380|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
73381|NCT01074268|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
73382|NCT01074255|Primary|Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy|The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).|Up to 14 days following the cessation of treatment|The Efficacy Evaluable Population consisted of participants treated with EMEND for 3 days and assessed by an investigator for efficacy. Participants were excluded from efficacy analysis for having a EMEND administration period less than 3 days (143 participants) or unavailability of final efficacy evaluation (1 participant).||participants|||Number
73384|NCT01074242|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis||Percent of participants|||Number
73385|NCT01074229|Secondary|24 Total Morphine Consumption|Total 24 total morphine consumption post operative.|1 day|||miligrams of morphine||Standard Deviation|Mean
73386|NCT01074229|Primary|QoR40 on the Day After Surgery|QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.|1 day|||units on a scale||Inter-Quartile Range|Median
73387|NCT01074216|Primary|To Achieve Target Vitamin D Level|To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks|Within 6 weeks of beginning vitamin D|||participants|||Number
73388|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the lichenification subscale score, lichenification is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
73389|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the excoriation subscale score, excoriation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
73390|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the infiltration/papulation subscale score, infiltration/papulation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
73391|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the erythema subscale score, erythema is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
73392|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining area subscale score, the percent area of skin involvement is determined and assigned a score of 0 to 6, where 0 correlates with no skin involvement, 1 represents < 10% skin involvement, 2 represents 10-29% skin involvement, 3 represents 30-49% skin involvement, 4 represents 50-69% skin involvement, 5 represents 70-89% skin involvement, and 6 represents 90-100% skin involvement. Possible scores range from 0 to 6, where 0 correlates with better disease severity and 6 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks|||units on a scale||Full Range|Median
73393|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and 4 weeks|||units on a scale||Full Range|Mean
73394|NCT01074164|Primary|Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score|The VAS score assesses itch intensity in subject’s with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled “Least Itch,” and the right boundary vertical line is labeled “Worst Itch.” Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity.|Baseline and 4 weeks|||centimeters||Full Range|Mean
73395|NCT01074125|Secondary|Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment|proportion was calculated separately for each treatment arm|Baseline and day 28|Intent-to-Treat||% of Participants|||Number
73396|NCT01074125|Secondary|Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment|Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.|Baseline and day 28|Intent-to-Treat, includes only subjects that had both baseline and end of study actual values||mg/dL||Standard Deviation|Mean
73397|NCT01074125|Primary|Change in Serum Phosphorus From Baseline to End of Treatment|Mean change from baseline was calculated separately for each treatment arm (LOCF)|Baseline and day 28|Intent to Treat (ITT) Population||mg/dL||Standard Deviation|Mean
73398|NCT01074099|Primary|Safety|as measured by frequency and severity of adverse events|through 1 Year post tx|||participants|||Number
73399|NCT01074099|Primary|Change in Cardiac Status (Classification)|A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation|Through 12 months post treatment|Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.|||||
73400|NCT01074047|Secondary|HRU: Rate of Transfusions Per Patient Year|HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||transfusions per patient year|||Number
73401|NCT01074047|Secondary|HRU: Rate of Transfusions|Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||participants|||Number
73402|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||hospitalizations per patient year|||Number
73403|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.||participants|||Number
73404|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73430|NCT01074047|Secondary|One-year Overall Survival Rate|Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|From Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||percentage of participants||95% Confidence Interval|Number
73405|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73406|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73407|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73408|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73409|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73410|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73431|NCT01074047|Primary|Kaplan-Meier Estimates for Overall Survival From Any Cause|Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||months||95% Confidence Interval|Median
73411|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73412|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73413|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73414|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73415|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. The analysis included 157 from the azacitidine group and 134 in the CCR group, a smaller number than the ITT population.||units on a scale||Standard Deviation|Mean
73416|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73475|NCT01073865|Secondary|Oestradiol (E2) Serum Concentrations at 24 Weeks|E2 serum concentrations (pg/mL) at 24 weeks|24 weeks after the first dosing|Full Analysis Set||pg/mL||Standard Deviation|Mean
73476|NCT01073865|Secondary|Number of Responders at 24 Weeks|Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.|24 weeks after the first dosing|Full Analysis Set||Patients|||Number
73784|NCT01070784|Primary|ECG Variables - RR Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
73417|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73418|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73419|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline to End of Study; at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73420|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. .||units on a scale||Standard Deviation|Mean
73421|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73422|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73785|NCT01070784|Primary|ECG Variables - QTcF Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
73423|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline to Cycle 3; at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.||units on a scale||Standard Deviation|Mean
73424|NCT01074047|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild – transient or mild discomfort; no medical intervention required; Grade 2 = Moderate – mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|Day 1 (randomization) up to last visit completed 22 Jan 2014; Up to 40 months|Safety population = all randomized participants who received at least 1 dose of study drug and had 1 post-dose safety assessment. Because the BSC only regimen consisted of blood products or antibiotics given as needed, those assigned to BSC only were included in the safety population if they had at least 1 post-randomization safety assessment.||participants|||Number
73425|NCT01074047|Secondary|Cytogenetic Complete Remission Rate (CRc-10) by the IRC|The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||participants|||Number
73426|NCT01074047|Secondary|Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates|The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.|Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.|Includes those who achieved a CR or CRi and assessed by the IRC; numbers of ITT participants in each treatment group||months||95% Confidence Interval|Median
73427|NCT01074047|Secondary|Overall Remission Rate (CR + CRi ) as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)|"Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods) AND an absolute neutrophil count of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response.~Morphologic complete remission with incomplete blood count recovery (CRi) is defined as a morphologic complete remission but the ANC count may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L."|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||participants|||Number
73428|NCT01074047|Secondary|Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)|Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.|Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months|Participants who achieved a CR or CRi||months||95% Confidence Interval|Median
73429|NCT01074047|Secondary|Event-free Survival (EFS)|Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.|Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored||months||95% Confidence Interval|Median
73507|NCT01073462|Primary|Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range|Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 – 31.8 pmol/L (150 to 300 pg/mL).|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.||percentage of participants|||Number
73432|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Mental Component Summary (MCS)|The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
73433|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Physical Component Summary (PCS)|The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
73434|NCT01074008|Other Pre-specified|Change From Baseline in EQ-5D (3 Level) Health Index Score|The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
73435|NCT01074008|Other Pre-specified|Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score|The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
73436|NCT01074008|Other Pre-specified|Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score|The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation.|Baseline up to Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||units on a scale||Standard Deviation|Mean
73437|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.||participants|||Number
73438|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.||participants|||Number
73508|NCT01073449|Secondary|Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|693 represents the number of patients implanted with an ICD within the whole population||Participants||95% Confidence Interval|Number
73786|NCT01070784|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
73439|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.||participants|||Number
73440|NCT01074008|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels < LLOQ (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and have at least one post-baseline measurement of HCV RNA levels.||percentage of participants|||Number
73441|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
73442|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
73443|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
73444|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
73445|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
73477|NCT01073865|Primary|Number of Patients With Progression-free Survival (PFS) at 24 Weeks|A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.|24 weeks after the first dosing|Full Analysis Set||Participants|||Number
73787|NCT01070784|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and 52 week after|||ms||Standard Deviation|Mean
73446|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
73447|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
73448|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
73449|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
73450|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng*hr/mL||Standard Deviation|Mean
73451|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||Hours||Standard Deviation|Mean
73452|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
73478|NCT01073657|Primary|"Supported Education Process Measure"|"Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the Supported Education Process Measure (Corrigan, 2009)."|6 months|Comparison of means||number of quarter hours||Standard Deviation|Mean
73509|NCT01073449|Primary|Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|||Participants||95% Confidence Interval|Number
73788|NCT01070784|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and 52 week after|||beats/minute||Standard Deviation|Mean
73453|NCT01074008|Secondary|Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR.|Baseline and Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and at least one post-baseline measurement of HCV RNA levels.||percentage of participants|||Number
73454|NCT01074008|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level < LLOQ (< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR.|Week 4|All participants who received at least one dose of study drug and had at least one post-baseline HCV RNA value were included in this efficacy analysis.||percentage of participants|||Number
73455|NCT01074008|Primary|Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment|Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.|Prior to dosing on Day 1 to before the morning dose on Day 4|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.||log10 IU/mL||Standard Deviation|Mean
73456|NCT01073943|Other Pre-specified|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
73457|NCT01073943|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.||participants|||Number
73458|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73459|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73460|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73461|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73462|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73463|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73464|NCT01073943|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
73465|NCT01073943|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
73466|NCT01073930|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.||participants|||Number
73467|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73468|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73469|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. One participant either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73470|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73471|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Two participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73472|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.||percentage of participants|||Number
73473|NCT01073930|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
73474|NCT01073930|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.||percentage of participants|||Number
73479|NCT01073631|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.|Baseline (Day 1) up to 2.1 Years|ITT; N=number of participants evaluated for mycological response.||Percentage of participants|||Number
73480|NCT01073631|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2.1 Years|Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once.||Percentage of participants|||Number
73481|NCT01073618|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study medication; Not evaluable=a follow-up mycological cultivation is not performed.|Baseline (Day 1) up to 2 years|ITT; N=number of subjects evaluated for mycological response.||percentage of participants|||Number
73482|NCT01073618|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2 years|Safety population: participants received at least 1 dose of study drug for the approved indication (=Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related parameters at least once.||percentage of participants|||Number
73483|NCT01073605|Secondary|Number of Subjects Reaching Puberty|The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.|Baseline, 1 to 6 years|Safety population. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years. Started = started puberty; Not Started = not started puberty yet as per Tanner scale.||participants|||Number
73484|NCT01073605|Secondary|Chronological Age at Onset of Puberty|Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.|Onset of puberty|Safety population. Number of participants analyzed = number of subjects who started puberty by the end of the study.||Years||Standard Deviation|Mean
73485|NCT01073605|Secondary|Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio|Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.|1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.||ratio||Standard Deviation|Mean
73486|NCT01073605|Secondary|Change From Baseline in Bone Age|Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year|Baseline, 1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point.||Years||Standard Deviation|Mean
73487|NCT01073605|Secondary|Weight||Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||kg||Standard Deviation|Mean
73488|NCT01073605|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||kg/m^2||Standard Deviation|Mean
73489|NCT01073605|Secondary|Change From Baseline in Height (SDS)|Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||SDS||Standard Deviation|Mean
73510|NCT01073449|Secondary|Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|2246 represents the number of patients in the whole population that were implanted with a PM||Participants||95% Confidence Interval|Number
73490|NCT01073605|Secondary|Height (SDS)|Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||SDS||Standard Deviation|Mean
73491|NCT01073605|Secondary|Change From Baseline in Height (cm)|Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||cm||Standard Deviation|Mean
73492|NCT01073605|Secondary|Height (cm)|Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||cm||Standard Deviation|Mean
73493|NCT01073605|Secondary|Change From Baseline in Annual Growth Rate SDS|Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.|Baseline, 1 to 3 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.||SDS||Standard Deviation|Mean
73494|NCT01073605|Secondary|Annual Growth Rate Standard Deviation Score (SDS)|Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.||SDS||Standard Deviation|Mean
73495|NCT01073605|Primary|Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm|Annual growth rate was expressed as height velocity (centimeter [cm]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx – Height Y{x-1}) / {(Date of Yx – Date of Y{x-1}) /365.25}|Baseline, 2 years|All subjects who received at least 1 study dose of Genotonorm were included in the Full Analysis Set (FAS). Number of Participants Analyzed = number of subjects with change in annual growth rate at 2 years.||cm/year||Standard Deviation|Mean
73496|NCT01073566|Secondary|Self-reported Hypoglycemic Episodes|Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.|6 weeks|Intent to treat||episodes|||Number
73497|NCT01073566|Secondary|Insulin Delivery System Rating|Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.|6 weeks|Per Protocol||units on a scale||Standard Deviation|Mean
73498|NCT01073566|Secondary|Glucose Profiles Per Day|Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days|6 weeks|Intent to Treat||mmol/L||Standard Error|Least Squares Mean
73499|NCT01073566|Primary|Mean Daily Blood Glucose|Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose|6 weeks|Intent to treat||mmol/L||Standard Error|Least Squares Mean
73500|NCT01073462|Secondary|Number of Participants With Cardiac Disease Progression|Cardiac disease progression was determined by the Investigator.|Month 3, 6, 12, 18, and 24|Intent-to-treat||participants|||Number
73501|NCT01073462|Secondary|Percentage of Participants Experiencing Hospitalization|The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.|24 months|Intent-to-treat||percentage of participants|||Number
73502|NCT01073462|Secondary|Percentage of Participants With at Least One Concomitant Medication|"The percentage of participants with at least one concomitant medication during the course of the study, by the following types:~Phosphate binder~Epoetin~Renin-Angiotensin-Aldosterone System (RAAS) inhibitors~Cinacalcet~Other"|24 months|Intent-to-treat||percentage of participants|||Number
73503|NCT01073462|Secondary|Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.|Baseline to Month 24|Intent-to-treat||percentage of participants|||Number
73504|NCT01073462|Secondary|Percentage of Participants With at Least a 30%-Reduction in iPTH Levels|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used.||percentage of participants|||Number
73505|NCT01073462|Secondary|Percentage of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|"Intent-to-treat; LOCF was used. n indicates the number of participants with available data at each time point."||percentage of participants|||Number
73506|NCT01073462|Secondary|Percentage of Participants With Hypercalcemia|Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used||percentage of participants|||Number
73511|NCT01073293|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
73512|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants||95% Confidence Interval|Number
73513|NCT01073293|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint||ELU/mL||95% Confidence Interval|Geometric Mean
73514|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants||95% Confidence Interval|Number
73515|NCT01073293|Primary|Percentage of Participants With a Systemic Adverse Experience|For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.|Up to 15 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
73516|NCT01073293|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
73517|NCT01073293|Primary|Percentage of Participants With a Repevax™ Injection-site Adverse Experience|For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
73518|NCT01073293|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
73519|NCT01073293|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||milli Merck Units/mL||Full Range|Geometric Mean
73782|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness|There are 5 alternatives (scored 0 to 4, 0= unaware of any difficulty and 4 =almost constant, present even when resting). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
73520|NCT01073267|Primary|Objective Response Rate|"Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).~Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score."|Baseline and at least 2 months|Intent to treat population.||proportion of participants|||Number
73521|NCT01073163|Secondary|Worst Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grades for Hematology Laboratory Tests Results Overall|Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Overall is defined as the worst postbaseline grade value for each patient and laboratory test across all cycles. Only postbaseline grades are summarized. If absolute neutrophil count (ANC) and neutrophils absolute (ABS) were both measured, the worse grade value from the two was summarized. Otherwise the worst ANC grade value or the worst neutrophils ABS grade value was summarized. WBC=white blood cell; LLN=lower limit of normal|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
73522|NCT01073163|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at Endpoint|The investigator assessed each patient’s ECOG performance status according to the ECOG scale at screening, on Day 1 of each treatment cycle, and at the end-of-treatment visit. Scale scores were: 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=dead. Any change in score to a higher value signifies worsening, and any change to a lower value signifies improvement.|End of study. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
73523|NCT01073163|Secondary|Overview of Adverse Events|Adverse event (AE)=any untoward medical occurrence in a patient administered study drug that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. Treatment-related AEs=those that began or worsened after treatment with study drug. AE severity was graded according to the National Cancer Institute's Common Terminology Criteria for AEs (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Relationship of an AE to study drug was categorized as definite, probable, possible, unlikely, or not related. Serious AE (SAE)=one that occurred at any dose that resulted in any of the following outcomes or actions: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; or an otherwise important medical event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
73524|NCT01073163|Secondary|Percentage of Participants With Overall Response|Overall Response was comprised of those participants who had Complete Response (CR) plus those who had Partial Response (PR), as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.||percentage of participants||95% Confidence Interval|Number
73525|NCT01073163|Secondary|Percentage of Participants With Complete Response (CR)|Complete response, as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.||percentage of participants||95% Confidence Interval|Number
73526|NCT01073163|Secondary|Rituximab Concentrations at 0.5 Hours, 24 Hours, and 7 Days Postinfusion||Day 1 of Cycle 1: prior to start of rituximab infusion, immediately postinfusion. Day 2 of Cycle 1: 15 minutes prior to the start of the bendamustine infusion. Day 7 and Day 14: anytime. Day 1 of Cycle 2: prior to start of rituximab infusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable serum concentration of rituximab.||mcg/mL||Full Range|Median
73527|NCT01073163|Secondary|Model-predicted Bayesian Bendamustine Clearance in the Presence of Rituximab|Boxplots of model-predicted Bayesian bendamustine clearance (CL) values in the presence of rituximab were generated based on the administered bendamustine doses, rate of infusion, and sample times.|Day 1 of Cycle 1: prior to start of bendamustine infusion, immediately postinfusion, 15 minutes and 30 minutes postinfusion. Day 2 of Cycle 1: 15 minutes prior to start of bendamustine infusion, 15 minutes, 30 minutes, 1, 3, and 5 hours postinfusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable bendamustine plasma concentration.||L/h||Full Range|Median
73624|NCT01072175|Secondary|Overall Survival in Part D|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. Validation of OS is currenlty ongoing; thus, data are not available at this time.|From the date of first dose until date of death due to any cause (up to approximately 14 months)||06/2017||||
73528|NCT01073163|Secondary|Change From Baseline in QTcF at Maximum Concentration (Cmax) of Bendamustine and Its Metabolites (M3 and M4)|Results from a pharmacokinetic-pharmacodynamic model to show the relationship of the overall predicted change from Baseline in QTcF at the average Cmax of bendamustine and its metabolites M3 and M4.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|Pharmacokinetic-pharmacodynamic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG and at least 1 ECG with a time-matched plasma concentration pair.||ms||95% Confidence Interval|Mean
73529|NCT01073163|Secondary|Number of Participants With Treatment-Emergent Cardiac Disorders|Number of participants with cardiac disorders overall, with severity from grades 1 (mild) to grade 4 (severe), according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Participants may have reported more than 1 event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.||participants|||Number
73530|NCT01073163|Secondary|Number of Participants With New Onset ECG Waveform Morphological Changes|The core ECG laboratory cardiologist assessed all leads in the ECGs and defined morphological changes. Changes from baseline (looking at each of the 3 ECGs at Day 2 Cycle 1 individually and the ECGs at all on-treatment time points individually) were noted for the following events: atrial fibrillation or flutter; second degree heart block; third degree heart block; complete right bundle branch block; complete left bundle branch block; ST segment depression; T wave abnormalities (negative T waves only); myocardial infarction pattern; any new abnormal U waves.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.||participants|||Number
73531|NCT01073163|Secondary|Number of Participants With QTcF New Outlier Events at End of Infusion and 1 Hour Postinfusion|Participants were considered to have an outlier ECG value based on the most extreme value across each of the time points. “New” means not present at baseline and becomes present on at least 1 on-treatment ECG time point. A participant had a new outlier event (500) if the maximum QTcF was >500 ms while their baseline was <=500 ms, or had an outlier event (480) if the maximum QTcF was >480 ms while their baseline was <= 480 ms. QTcF in the 30-60 ms or >60 ms categories were also considered outliers.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.||participants|||Number
73532|NCT01073163|Secondary|Mean Change From Baseline in QTcF at 1 Hour Postinfusion|On Day 2 of Cycle 1, three ECGs were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine 1 hour postinfusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.||ms||Standard Deviation|Mean
73533|NCT01073163|Primary|Mean Change From Baseline in QT Interval as Corrected by the Fridericia Method (QTcF) at End of Infusion|On Day 2 of Cycle 1, three electrocardiograms (ECGs) were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine at the end of the infusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.||milliseconds (ms)||Standard Deviation|Mean
73534|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73535|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73789|NCT01070784|Primary|Vital Signs- Pulse Rate|Change from baseline|Baseline and 52 week after|||beats/minute||Standard Deviation|Mean
73536|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73537|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73538|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73539|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73540|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73541|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73542|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73749|NCT01071070|Secondary|The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL|The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL|Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
73543|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73544|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73545|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73546|NCT01072929|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant’s insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
73547|NCT01072929|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
73548|NCT01072929|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
73549|NCT01072929|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.||participants|||Number
73557|NCT01072877|Secondary|Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance|The Independent Photography Review – Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient’s visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins).|8 weeks post treatment|Population consists of all patients who had a baseline and on-treatment assessment.||units on a scale||Standard Error|Mean
73550|NCT01072929|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73551|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73552|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73553|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73554|NCT01072929|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
73555|NCT01072929|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
73556|NCT01072929|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
73606|NCT01072526|Primary|Change in Ocular Surface Disease Index (OSDI)|Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.|Start of treatment, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
73558|NCT01072877|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from “Not at all noticeable” (a score of 0) to “Extremely noticeable” (a score of 4).|8 weeks|||units on a scale||Standard Error|Mean
73559|NCT01072877|Primary|Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)|"The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient’s level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching).~The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity).~At Visit 2/baseline, Week 8, scores were calculated"|Week 8|||units on a scale||Standard Error|Mean
73560|NCT01072773|Secondary|Duration of Response|Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.|Duration of Study (up to 5 years)|Neither participant achieved a response. Therefore, no duration of response calculation was performed.|||||
73561|NCT01072773|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death|Duration of Study (up to 5 years)|||Months||95% Confidence Interval|Median
73562|NCT01072773|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause.|Duration of Study (up to 5 years)|||Months||95% Confidence Interval|Median
73563|NCT01072773|Secondary|Number of Participants With an Organ Response.|The number of patients that acheived a response in an affected organ.|Duration on treatment (up to 12 cycles/months)|||participants|||Number
73564|NCT01072773|Secondary|Number of Participants With Treatment Related Adverse Events.|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.~Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE~Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0."|Duration on treatment (up to 12 cycles/months)|||participants|||Number
73565|NCT01072773|Primary|Number of Participants With a Confirmed Hematologic Response|"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of treatment (up to 12 cycles/months)|||participants|||Number
73566|NCT01072669|Primary|Digital Micro-vascular Flow|Change in digital micro-vascular flow measured by LDPI in patients with Raynaud’s phenomenon (RP) and digital ischemia secondary to SSc at 1 week and 12 weeks|Baseline and 12 weeks|Assuming a standard deviation of 0.40, and use of a two-sample t-test with significance level of 0.05, there will be 80% power to detect differences in the change from baseline of at least 0.65 units if moderate correlation (r=0.50) exists, and 0.45 units if strong correlation (r=0.75) exists between treated||perfusion unit||95% Confidence Interval|Mean
73567|NCT01072656|Secondary|A 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index) at the End of the Open Label Phase Compared to the Pre-implantation Baseline||24 months post randomization follow up||03/2017||||
73568|NCT01072656|Primary|Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)|Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, & Self-care. This is an average score of the 3 month period for each Active and Sham phase.|Blinded stimulation phase (3 Months)|||participants|||Number
73569|NCT01072643|Secondary|To Demonstrate That DEX is a Safe Sedative in Pediatric Subjects With PHTN||24 hours||||||
73570|NCT01072643|Secondary|To Obtain Pharmacokinetic Data in This Population||6 hours||||||
73571|NCT01072643|Secondary|To Quantify the Effect of DEX on PVR in Pediatric Subjects With Pulmonary Hypertension and Its Dependence on Baseline PVR||Every individual patient will be studied over maximum of 4 hours during the dose escalation phase. This part of the study will be completed in 1 year||||||
73572|NCT01072643|Secondary|Efficacy of Sedation With DEX||Subjects will participate in a dose escalation study which will define minimal effective dose that results in effective sedation in ≥ 7 out of 8 patients in that dose cohort. Maximum upto 4 hours||||||
73573|NCT01072643|Primary|The Primary Endpoint Will be the Change in PVR in Wood Units|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization;|For each subject PVR will be measured by cardiac catheterization at T0 ( baseline measurement) , after DEX bolus (T1) which is given over 10 minutes and after 30 mins after start of the DEX infusion (T2) - Maximum upto 4 hours|||wood units|||Number
73790|NCT01070784|Primary|Vital Signs- Sitting Diastolic Blood Pressure(DBP)|Change from baseline|Baseline and 52 week after|||mmHg||Standard Deviation|Mean
73574|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73575|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73576|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73577|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73578|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73579|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73580|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73581|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73582|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73583|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73584|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73585|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.||participants|||Number
73586|NCT01072630|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
73587|NCT01072630|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.||units on a scale||Standard Deviation|Mean
73622|NCT01072188|Primary|Air Blast|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|Immediately after product application|||Units on a scale||Standard Deviation|Mean
73791|NCT01070784|Primary|Vital Signs- Sitting Systolic Blood Pressure(SBP)|Change from baseline|Baseline and 52 week after|||mmHg||Standard Deviation|Mean
73588|NCT01072630|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug.||units on a scale||Standard Deviation|Mean
73589|NCT01072630|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug||participants|||Number
73590|NCT01072630|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73591|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73592|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73593|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.||units on a scale||Standard Deviation|Mean
73594|NCT01072630|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
73623|NCT01072188|Primary|Hypersensitivity to Touch (Tactile)|Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.|Immediately after product application|||Units on a scale||Standard Deviation|Mean
73595|NCT01072630|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.||percentage of participants|||Number
73596|NCT01072630|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
73597|NCT01072539|Secondary|Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)|Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.|At the TOC or EOT assessment|Effectiveness Analysis Set from the prospective study phase; n refers to the total munber of participants who had evaluable data.||Percentage of Participants|||Number
73598|NCT01072539|Primary|Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics|Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.|From the time of the participant’s first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Analysis Set.||Percentage of Participants||95% Confidence Interval|Number
73599|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site|Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as “effective” to the treatment of Tygacil .|At the TOC or EOT assessment|Effectiveness Analysis Set.||Percentage of Participants||95% Confidence Interval|Number
73600|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment|Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as “effective” to the treatment of Tygacil .|At the TOC or EOT assessment|Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least.||Percentage of Participants||95% Confidence Interval|Number
73601|NCT01072539|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs|All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely”, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.|From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Anaysis Set||Percentage of Participants|||Number
73602|NCT01072526|Other Pre-specified|Change in Severity of Ocular Discomfort|This will be calculated using a composite score of the primary and secondary outcome measures.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
73603|NCT01072526|Secondary|Change in Schirmer Tear Test With Anesthesia Result|Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
73604|NCT01072526|Secondary|Change in Fluorescein Staining Scale|Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
73605|NCT01072526|Secondary|Change in Tear Film Breakup Time|Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.|||||
73792|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
73793|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
73607|NCT01072500|Secondary|Persistent Mobility Disability (Assessed Every 6 Months)|The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death.|Median 2.7 years/Average 2.6 years|||participants|||Number
73608|NCT01072500|Primary|Major Mobility Disability, Defined as Incapacity to Walk 400 Meters|The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.|Median 2.7 years/Average 2.6 years|||participants|||Number
73609|NCT01072448|Secondary|Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)|An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|End of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
73610|NCT01072448|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
73611|NCT01072409|Primary|CNC Monosyllabic Word Performance - Treated Ear|CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.|12 months|||percent correct||Standard Error|Mean
73612|NCT01072396|Secondary|Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime|Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
73613|NCT01072396|Secondary|Constant Work Rate (CWR) Endurance Time|CWR exercise duration calculated as the length of time of the exercise period|six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.||seconds||Standard Error|Least Squares Mean
73614|NCT01072396|Primary|Change From Baseline in Inspiratory Capacity (IC) at Isotime|Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.||liter||Standard Error|Least Squares Mean
73615|NCT01072331|Primary|Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)||4 weeks|||mg・h / dL||Standard Error|Least Squares Mean
73616|NCT01072331|Secondary|Change From Baseline in Fasting Plasma Glucose||4 weeks|||mg / dL||Standard Error|Least Squares Mean
73617|NCT01072331|Secondary|Change From Baseline in 24-h Mean Glucose||4 weeks|||mg / dL||Standard Error|Least Squares Mean
73618|NCT01072331|Primary|Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)||4 weeks|||mg / dL||Standard Error|Least Squares Mean
73619|NCT01072201|Primary|Mean Percentage of Plaque Scores|Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.|6 Months|||percentage of dental plaque||Standard Deviation|Mean
73620|NCT01072201|Primary|Mean Pocket Depth|Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.|6 Months|||Millimeters||Standard Deviation|Mean
73621|NCT01072201|Primary|Bleeding on Probing|Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.|6 months|||Percentage of bleeding sites||Standard Deviation|Mean
73625|NCT01072175|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator in Part D|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 13 months)|ITT Population||Months||95% Confidence Interval|Median
73626|NCT01072175|Secondary|Duration of Response as Assessed by the Investigator in Part D|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 13 months)|ITT Population. Only those participants who had CR or PR were considered.||Months||95% Confidence Interval|Median
73627|NCT01072175|Secondary|Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants in Part D|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 milimeter [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment should be performed no less than 28 days after the criteria for response are first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the date of first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 280 days )|ITT Population||Participants|||Number
73628|NCT01072175|Secondary|Area Under the Concentration-time Curve Assessment of Trametinib in Part D|AUC(0-tau) after single and repeat dose of teametinib alone and in combination with dabrafenib was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, AUC(0-tau) was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng*h/mL||95% Confidence Interval|Geometric Mean
73629|NCT01072175|Secondary|The Tmax Assessment of Trametinib in Part D|The tmax of trametinib after single and repeat dose in combination with dabrafenib (DAB) was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, tmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||Hours||Full Range|Median
73630|NCT01072175|Secondary|The Cmax Assessment of Trametinib in Part D|Cmax of trametinib after single and repeat dose in combination with DAB was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, Cmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
73631|NCT01072175|Secondary|Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites in Part D|Area under the concentration-time curve (AUC) from pre-dose to dosing interval (AUC[0-tau]), from pre-dose to the last time of quantifable concentration (AUC[0-tau]), and from pre-dose extrapolated to infinity (AUC[0-inf]) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
73632|NCT01072175|Secondary|The Tmax of Dabrafenib Metabolites in Part D|The time to Cmax (tmax) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measuered at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||Hours||Full Range|Median
73633|NCT01072175|Secondary|Cmax of Dabrafenib Metabolites in Part D|The maximum concentration (Cmax) of dabrafenib metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
73634|NCT01072175|Secondary|Oral Volume of Distribution (V/F) of Dabrafenib and Trametinib|Oral volume of distribution (V/F) of dabrafenib and trametinib were assessed using a population approach. Oral volume of distribution (V/F) is defined as the apparent volume of distribution in the central compartment.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population||Liters (L)||95% Confidence Interval|Mean
73635|NCT01072175|Secondary|Oral Clearance (CL/F) of Dabrafenib and Trametinib|Oral clearance (CL/F) of dabrafenib and trametinib were assessed using a population approach. Oral clearance (CL/F) is defined as the apparent volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. For dabrafenib, population CL/F is defined as inducible and non-inducible CL/F. As dabrafenib induces its own metabolism, total oral clearance at steady state includes a non-induced (Day 1) component and an induced component, as estimated by a population PK model.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population||Liters per hour (L/hr)||95% Confidence Interval|Mean
73636|NCT01072175|Secondary|Plasma Concentrations of Trametinib in Part C|Plasma concentrations of trametinib was assessed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng/mL||Full Range|Median
73637|NCT01072175|Secondary|Plasma Concentrations of Dabrafenib and Its Metabolites in Part C|Plasma concentrations of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were assesed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng/mL||Full Range|Median
73638|NCT01072175|Secondary|Overall Survival (OS) in Part C|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. When calculating overall survival, deaths following crossover were included.|From the date of randomization until date of death due to any cause (up to approximately 17 months)|ITT Population||Months||95% Confidence Interval|Median
73639|NCT01072175|Secondary|Pre- and Post-dose H-scores for Individual Participants in Part B|p-ERK and p-AKT, biomarkers in tumor biopsies, were assessed for participants with BRAF mutant colorectal cancer. The H-score, which is a composite score that comprises intensity and percentage of staining, is a method of assessing the amount of protein or phospho-protein present in a biopsy sample. The score is obtained by the formula: (3 * percentage of strongly staining nuclei) + (2 * percentage of moderately staining nuclei) + (percentage of weakly staining nuclei). The H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Screening and at disease progression (up to approximately 8 months)|Biomarker Population: participants with H-score data for pre- and post-biopsy pairs||scores on a scale|||Number
73640|NCT01072175|Secondary|Overall Survival (OS) in Part B BRAFi Naïve Melanoma Participants|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.|From the date of first dose until date of death due to any cause (up to approximately 22 months)|All Treated Population.||Months||95% Confidence Interval|Median
73641|NCT01072175|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma in Part B|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve were the participants with BRAF-mutation positive melanoma who had not received prior therapy with a BRAF-inhibitor..|From the date of first dose to the earliest date of disease progression (PD) or death due to any cause (up to approximately 22 months)|All Treated Population.||Months||95% Confidence Interval|Median
73642|NCT01072175|Secondary|Duration of Response as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma in Part B|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 22 months)|All Treated Population. Only those participants who had a CR or PR were analyzed.||Months||95% Confidence Interval|Median
73680|NCT01072136|Secondary|Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo.|The proportion of participants with mycoplasma genitalium at baseline who clear mycoplasma genitalium in either the vagina or cervix at their last follow-up visit.|At 2-3 weeks and 2 month (Day 50-70) follow-up.|Participants who were positive for mycoplasma genitalium in either the cervix or vagina at baseline and who met eligibility criteria and who returned for at least one of the follow-up visits.||participants|||Number
73643|NCT01072175|Secondary|Number of Participants With BRAFi-naïve Mutant Metastatic Melanoma With the Best Overall Response as Assessed by Investigator in Part B|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 milimeter [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to 103 weeks)|All Treated Population||Participants|||Number
73644|NCT01072175|Secondary|The Tmax Assessment of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|The tmax is defined as the time of occurrence of Cmax. The PK parameter for tmax was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.||Hours||Full Range|Median
73645|NCT01072175|Secondary|The Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
73646|NCT01072175|Secondary|The AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|AUC (0-tau) is defined as area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration. AUC (0-tau) was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
73647|NCT01072175|Secondary|The Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib in Part B|The tmax is defined as the time of occurenceof Cmax. Tha tmax was assessed for plasma dabrafenib (DAB) following repeat dosing of dabrafenib 75 and 150 mg BID administered in combination with trametinib. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.||Hours||Full Range|Median
73648|NCT01072175|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib in Part B|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma dabrafenib (DAB) following repeat dosing of DAB administered in combination with trametinib (T). The trough concentration is defined as the plasma level of a pharmaceutical product measured just before the next dose. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.||ng/mL||95% Confidence Interval|Geometric Mean
73649|NCT01072175|Secondary|The AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib (T) in Part B|Area under the concentration-time curve from time zero (predose) until the last time of quantifiable concentration (AUC [0-tau]) was assessed. Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
73650|NCT01072175|Secondary|Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib in Part A|The steady state plasma concentration (Css) of trametinib with concomitant dabrafenib administration was assessed at Day 15 and Day 16. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated.|Day 15 and Day 16|PK Population||ng/mL||Full Range|Median
73651|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part D|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heartbeats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population||Participants|||Number
73750|NCT01071070|Primary|The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels|The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values|Baseline to 12 Weeks|The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population.||participants|||Number
73652|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part D|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included lymphocytes, total neutrophils, hemoglobin, white blood cell count, platelet count, monocytes, mean corpuscle hemoglobin concentration, eosinophils, basophils, mean corpuscle hemoglobin, mean corpuscle volume, red blood cell count, hematocrit, erythrocyte sedimentation, reticulocytes. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population. Only those participants available at indicated timepoints were analyzed.||Participants|||Number
73653|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part D|Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Changes above (High) and below (Low) the normal range were evaluated for parameters not graded. Included:hyponatremia,gamma glutamyltransferase (GGT),aspartate aminotransferase (AST),hyperglycemia,alkaline phosphatase,hypokalemia,alanine aminotransferase (ALT),phosphorus inorganic,creatine kinase,total bilirubin,albumin,hyperkalemia, hypomagnesemia,lipase,hypokalemia,hyponatremia,urea/blood urea nitogen (BUN),bicarbonate,creatine clearance,chloride,C-reactive protein,total protein,uric acid,troponin I,direct bilirubin,creatine kinase MB mass, chloride,total protein,bicarbonate,uric acid,creatine clearance,lactate dehydrogenase. Worst case change from BL was calculated as the post-BL value minus the BL value.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population. Only those participants available at indicated timepoints were analyzed.||Participants|||Number
73654|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part D|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event for possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population||Participants|||Number
73655|NCT01072175|Primary|AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|The PK parameters were determined for area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration AUC (0-tau) and from time zero (pre-dose) extrapolated to infinite time AUC (0-inf). Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour only on Day 1) post-dose administration.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.||ng*hr/mL||95% Confidence Interval|Geometric Mean
73656|NCT01072175|Primary|The Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|tmax is defined as the time of occurenceof Cmax. Blood samples for PK analysis of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.||Hours||Full Range|Median
73657|NCT01072175|Primary|Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|The PK parameter Cmax was assessed. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 1 and Day 21|PK Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed||ng/mL||95% Confidence Interval|Geometric Mean
73658|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part C (Randomized)|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, milimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximlately 75 weeks)|ATP Population||Participants|||Number
73659|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part C (Randomized)|Hematology parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included: hemoglobin, lymphocytes, Total absolute neutrophil count (ANC), platelet count, white blood cells (WBC) count. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
73794|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total|Change from baseline|Baseline and 52 week after|||g/dL||Standard Deviation|Mean
73660|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part C (Randomized)|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3 or Grade 4 occurred. For clinical chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Clinical chemistry parameters included: albumin, alkaline phosphate (ALKP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total Bilirubin, calcium, creatine kinase, creatinine, gamma glutamyltransferase (GGT), glucose, potassium, magnesium, sodium, inorganic phosphorus. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
73661|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part C (Randomized)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximatley 75 weeks)|ATP Population||Participants|||Number
73662|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Investigator in Part C (Crossover)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants received anti-cancer therapy prior to the date of documented events, and censored at the last adequate assessment, prior to the initiation of therapy. If the participant did not have a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 9 months)|Crossover Population||Months||95% Confidence Interval|Median
73663|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (BICR) in Part C (Randomized)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the BICR according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 17 months)|ITT Population||Months||95% Confidence Interval|Median
73664|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Investigator in Part C (Randomized)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 17 months)|ITT Population||Months||Full Range|Median
73665|NCT01072175|Primary|Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR) in Part C (Randomized)|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 17 months)|ITT Population. Only those participants who had a CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
73716|NCT01071278|Primary|Number of Participants With Lipid Panel Control|Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).|From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)|Results are for the Intent-to-Treat (ITT) Population. Information regarding the participation in a disease management program was not reported for 63 participants in the ITT Population.||participants|||Number
73666|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator in Part C (Crossover)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 15 weeks)|Crossover Population: participants who were randomized to and received at least one dose of dabrafenib monotherapy, and who elected to crossover to combination therapy following disease progression while on monotherapy||Participants|||Number
73667|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR) in Part C (Randomized)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by BICR as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 36 weeks)|ITT Population||Participants|||Number
73668|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator in Part C (Randomized)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters [mm] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 47 weeks)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered||Participants|||Number
73669|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part B|Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population||Participants|||Number
73670|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part B|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included: lymphocytes decreased, total neutrophils, hemoglobin decreased, white blood cell counts, platelet counts, monocytes, mean corpuscular hemoglobin concentration (MCHC), eosinophils, basophils, mean corpuscular hemoglobin, mean corpuscular volume, red blood cell count, hemotocrit, and reticulocytes.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
73671|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part B|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For clinical chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Clinical chemistry parameters included: hyponatremia, gamma glutamyltransferase (GGT), phosphorous inorganic, alkaline phosphatase, hyperglycemia, aspartate aminotransferase (AST), hypokalemia, albumin, alanine aminotransferase (ALT), total bilirubin, hyperkalemia, hypoglycemia, creatinine, lactate dehydrogenase, urea/blood urea nitrogen (BUN), bicarbonate, chloride, creatine clearance, total protein, uric acid, and troponin T.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.||Participants|||Number
73672|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part B|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks )|All Treated Participants (ATP) Population: all participants who received at least one dose of either dabrafenib or trametinib||Participants|||Number
73673|NCT01072175|Primary|AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites in Part A|Blood samples for PK analysis of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. AUC is defined as the area under the dabrafenib concentration-time curve as a measure of drug exposure. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC (0-t) is defined as area under the concentration-time curve from time zero (pre-dose) to the last time of quantifiable concentration. Date are reported as geometric least square means.|Day 15|PK Population||ng*hour/mL (ng*hr/mL)||95% Confidence Interval|Geometric Mean
73674|NCT01072175|Primary|Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametnib in Part A|Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 15|Pharmacokinetic (PK) Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed||Nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
73675|NCT01072149|Secondary|Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period|Change from period Baseline in 0-25 hour serial FEV1 (0 to 25 hours) over Period Days 28-29 was measured. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Analysis was performed using a mixed effects repeated measures model with covariates of period treatment group, period Baseline, mean Baseline, period and time after dosing (nominal), in addition to time after dosing by period Baseline, time after dosing by mean Baseline, and time after dosing by period treatment interaction terms as fixed effects and participant as a random effect.|Baseline; pre-dose; 5 minutes, 15 minutes, 30 minutes, 60 minutes, and 2, 4, 6, 8, 12, 16, 20, 22, 23, 24, and 25 hours post-dose on Day 28 and Day 29 of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
73676|NCT01072149|Secondary|Change From Period Baseline in Clinic Visit Trough FEV1 at the End of Each 28-day Treatment Period|Trough FEV1 is defined as the mean of the 23- and 24-hour post-dose assessments. For each treatment period, period Baseline is defined as the mean of the -30 and -5 minute measurements taken on Period Day 1. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Change from Baseline was calculated as the value at Period Day 29 minus the value at Baseline. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline, and period as fixed effects and participant as a random effect.|From Baseline to the end of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
73677|NCT01072149|Primary|Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period|FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.|Pre-dose and the end of each 28-day treatment period (up to 19 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one dose of trial medication in any treatment period. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Least Squares Mean
73678|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm.|"Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC's per oil immersion field on cervical gram stain."|At 2-3 weeks follow-up.|Received study product, met all eligibility criteria, and had complete outcome data at 2-3 weeks.||percentage of participants|||Number
73679|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm.|"Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month ( Day 50-70) follow-up.|Per protocol. Received study product, met all eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.||percentage of participants|||Number
73717|NCT01071252|Secondary|To Assess the Time to Relapse|Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.|37 weeks|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||days||95% Confidence Interval|Median
73681|NCT01072136|Secondary|Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 months according to mycoplasma genitalium status(positive cervical or vaginal swabs versus both negative) at 2 months.~Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas at 2-month follow-up.||percentage of participants|||Number
73682|NCT01072136|Secondary|Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 month follow-up according to asymptomatic bacterial vaginosis status at 2 month follow-up.~Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas or cervical mycoplasma genitalium at 2 month follow-up.||percentage of participants|||Number
73683|NCT01072136|Secondary|Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The proportion of participants experiencing one or more adverse events after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.||percentage of participants|||Number
73684|NCT01072136|Secondary|Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The number of participants experiencing PID after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.||participants|||Number
73685|NCT01072136|Primary|Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC).|The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 white blood cells per oil immersion field on cervical gram stain.|Visit 2 - 2 months (Day 50-70).|Per protocol. Received study product, met eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.||percentage of participants|||Number
73686|NCT01072032|Secondary|EEG Spectral Coherence Estimates|EEG coherence reflects the degree to which brain regions communicate. It is derived from calculating the degree of association between regions in specified frequency bandwidths; it is like a correlation, except that the values range from 0-1 instead of -1 to 1, so technically there are no units as it is a coefficient. Higher coherence values indicate stronger associations between regions.|3 weeks|||Coherence ratio||Standard Deviation|Mean
73687|NCT01072032|Secondary|Functional Walking Measures|Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).|3 weeks|||cm/s||Standard Deviation|Mean
73688|NCT01072032|Primary|Motor Control|Normalized jerk is a measure of movement smoothness, derived from jerk [(meters)/(second cubed)] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s^2)|3 weeks|||1/s^2||Standard Deviation|Mean
73689|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|To Day 196|Safety analyis population||participants|||Number
73690|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|To Day 196|Safety analysis population||participants|||Number
73691|NCT01071915|Secondary|Cumulative Probability of no PSA Failure From Day 28 to Day 196|PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.|To Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196||percent probability||95% Confidence Interval|Mean
73692|NCT01071915|Secondary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196||Day 56 to Day 196|152 participants for this outcome measure is the analysis population from day 56 to day 196||percent probability||95% Confidence Interval|Mean
73693|NCT01071915|Secondary|Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28||To Day 28|152 participants for this outcome measure is the analysis population from day 0 to day 28||percent||Inter-Quartile Range|Median
73694|NCT01071915|Secondary|Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3||At day 3|Observed cases||percent||95% Confidence Interval|Number
73695|NCT01071915|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196||Day 28 to Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196||percent probability||95% Confidence Interval|Mean
73733|NCT01071200|Secondary|Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.||IU||Standard Deviation|Mean
73696|NCT01071798|Secondary|Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Subpopulation With Two Cycles, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 2|Subpopulation With Two Cycles with HAQ Score||participants|||Number
73697|NCT01071798|Secondary|Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Main Analysis Set participants with only one treatment cycle, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 1|Main Analysis Set with HAQ Score||participants|||Number
73698|NCT01071798|Secondary|Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)||during Cycle 1, during Cycle 2, during the trial (within 12 months)|||percentage of participants|||Number
73699|NCT01071798|Primary|HAQ Disability Index (HAQ-DI)|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle|||units on a scale||Standard Deviation|Mean
73700|NCT01071798|Primary|DAS28 Score|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity.|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle|||units on a scale||Standard Deviation|Mean
73701|NCT01071538|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|8 weeks|||beats per minute||Standard Deviation|Mean
73702|NCT01071538|Secondary|Pain Numeric Rating Scale (20 Item)|measure of average physical pain score range 0-20 Higher scores indicate worse outcome|8 weeks|||units on a scale||Standard Deviation|Mean
73703|NCT01071538|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 – 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 – 50, with lower scores representing lower levels of negative affect."|8 weeks|||units on a scale||Standard Deviation|Mean
73704|NCT01071538|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|8 weeks|||units on a scale||Standard Deviation|Mean
73705|NCT01071538|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|8 weeks|||units on a scale||Standard Deviation|Mean
73706|NCT01071538|Primary|Blood Pressure|Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.|8 weeks|||mm Hg||Standard Deviation|Mean
73707|NCT01071538|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity theoretical scale range 0-60 Lower values represent better outcome|8 weeks|||units on a scale||Standard Deviation|Mean
73708|NCT01071395|Secondary|Safety Monitoring Will be Operative Throughout the Study||18 months||||||
73709|NCT01071395|Secondary|Correlations Between Scale Values and Clinical Global Impressions-Severity (CGI-s) and Correlations Between Scale Changes and Clinical Global Impression of Change (CGI-c)||18 months||||||
73710|NCT01071395|Secondary|Correlations Among the Scales||18 months||||||
73711|NCT01071395|Secondary|If Sufficient Number Are Maintained on 200 mg/Day, Differences in Change Scores Between 200 mg/Day and 300 mg/Day Amantadine. (This Analysis Will be BL vs End of Study)||18 months||||||
73712|NCT01071395|Secondary|Change Score Differences Between Week 4 and 8 to Measure Stability of Scales Over Two Visits on Stable Doses of Amantadine or Placebo||18 months||||||
73713|NCT01071395|Secondary|Differences in Slope From Baseline (BL) to End of Study (Data Will Include the 4 Week Scores) Between Placebo and Amantadine to Determine Which Scales Demonstrate Sensitivity Across Time.||18 months||||||
73714|NCT01071395|Primary|The Investigators Will Assess Effect Size With Each Scale for Detecting Change From Baseline and Change Between Amantadine and Placebo; Allowing Assessment of Sensitivity and Specificity for Each Scale Based on Receiver Operator Characteristics (ROC).|Analyses of primary outcome measures tested sensitivity to change in dyskinesia (time effect) as well as sensitivity to differences in treatment effect (time-by-treatment interaction). These analyses were conducted using repeated-measures ANOVA (RM-ANOVA) or nonparametric analyses (Friedman’s ANOVA with follow-up Wilcoxon tests). The RM-ANOVAs tested for changes in scale scores over baseline, week 4, and week 8 visits across the entire sample (time effect), as well as differences in these changes over time between treatment groups (time-by-treatment interaction). Effect size of time to change was compared using a partial eta-square estimate of effect size. An eta-squared less than or equal to 0.01 is considered small; 0.06 is considered medium; and, 0.14 is considered large.|18 months|||unitless|||Number
73715|NCT01071278|Secondary|Number of Participants Who Reported Adverse Events||Up to 22 weeks|||participants|||Number
73734|NCT01071200|Primary|Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes||Baseline (Stimulation day 8 [S8]) until hCG day|"Modified intention-to-treat (mITT) population included all randomized participants who entered in the experimental phase at S8. Here N represents number of participants analyzed for this measure."||IU||Standard Deviation|Mean
73718|NCT01071252|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||Percentage of Participants|||Number
73719|NCT01071252|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Response|IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||percentage of participants|||Number
73720|NCT01071252|Primary|Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|week 13|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.||percentage of participants|||Number
73721|NCT01071200|Secondary|Number of Cycles Cancelled Due to Risk of OHSS|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.||cycles|||Number
73722|NCT01071200|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.||participants|||Number
73723|NCT01071200|Secondary|Percentage of Participants With Implantation|Implantation is the attachment and subsequent penetration by the zona-free blastocyst (usually in the endometrium) that starts five to seven days after fertilization.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||percentage of participants|||Number
73724|NCT01071200|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||percentage of participants|||Number
73725|NCT01071200|Secondary|Percentage of Participants With Pregnancy||12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||percentage of participants|||Number
73726|NCT01071200|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus or Fallopian tube.|Day 3 post-hCG (ET)|mITT population included all randomized participants who entered in the experimental phase at S8.||embryos|||Number
73727|NCT01071200|Secondary|Number of Obtained Embryos|Total number of obtained embryos with maximum 3 inseminated oocytes was calculated.|Day 3 post-hCG (Embryo transfer [ET])|mITT population included all randomized participants who entered in the experimental phase at S8.||embryos|||Number
73728|NCT01071200|Secondary|Fertilization Rate|Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3).|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.||ratio||Standard Deviation|Mean
73729|NCT01071200|Secondary|Mean Number of Mature Oocytes (Metaphase II)|Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|34-36 hours post-hCG (OPU)|"mITT population included all randomized participants who entered in the experimental phase at S8. Here N represents those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope."||Metaphase II Oocytes||Standard Deviation|Mean
73730|NCT01071200|Secondary|Mean Total Number of Retrieved Oocytes|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-36 hours post-hCG (OPU)|mITT population included all randomized participants who entered in the experimental phase at S8.||oocytes||Standard Deviation|Mean
73731|NCT01071200|Secondary|Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day||Baseline (S8) and hCG day|"mITT population included all randomized participants who entered in the experimental phase at S8. Here “N” represents number of participants analyzed and n represents the number of participants with plasma E2 levels at specified time points for respective treatment groups."||picogram/milliter (pg/mL)||Standard Deviation|Mean
73732|NCT01071200|Secondary|Mean Number of Ovarian Stimulation Days||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.||Days||Full Range|Mean
73795|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Albumin|Change from baseline|Baseline and 52 week after|||g/dL||Standard Deviation|Mean
73735|NCT01071096|Secondary|Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders|Only cytokines with a mean densimetric value 1.65 times the background grey value in a minimum of 3 patients were considered detectable. These are reported below. Values normalized to positive control array spots after background subtraction: C5/C5a, CD40 Ligand, Granulocyte Colony Stimulating Factor (G-CSF), Growth Regulated Oncogene(GRO)-alpha, Soluble Intercellular Adhesion Molecule (sICAM)-1, Interferon gamma (IFN-y), Interleukin(IL)-1alpha, 1beta, 1ra, 8, 16, 17E, & 23, Interferon Gamma-Induced Protein 10 (IP-10), Interferon-inducible T cell alpha chemoattractant (I-TAC), Macrophage Migration Inhibitory Factor (MIF), Serpin E1, and Regulated Upon Activation Normal T-cell Expressed (RANTES)|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapy|Number of Participants Analyzed is low due to some unusable samples and missing samples making comparison between months impossible. 5 Responders and 5 Non-Responders provided enough samples at all time points for comparisons.||Florescent Units (FU)||Standard Deviation|Mean
73736|NCT01071096|Secondary|Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline|Saliva samples collected at Baseline (at no headache or lowest level of headache), at headache attack directly before taking rescue medication and 2 hours after treating with rescue medication.|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3|||pmol/mg total protein||Standard Deviation|Mean
73737|NCT01071096|Secondary|Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)|CGRP Level collected each month when subject did not have a headache or was at lowest pain level of headache that month.|Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7|||pmol/mg total protein||Standard Error|Mean
73738|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7|||days||Standard Deviation|Mean
73739|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7|||days||Standard Deviation|Mean
73740|NCT01071083|Secondary|Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.|MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.||Percentage of subjects meeting criteria|||Number
73741|NCT01071083|Primary|Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.|Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.||Percentage of subjects meeting criteria|||Number
73742|NCT01071070|Secondary|The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)|The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)|Baseline to 12 weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||participants|||Number
73743|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||beats per minute||Standard Deviation|Mean
73744|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mm Hg||Standard Deviation|Mean
73745|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mm Hg||Standard Deviation|Mean
73746|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium-phosphorus Product||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mg^2/dL^2||Standard Error|Mean
73747|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||mg/dL||Standard Error|Mean
73748|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.||pg/mL||Standard Error|Mean
73796|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S- Calcium|Change from baseline|Baseline and 52 week after|||mg/dL||Standard Deviation|Mean
73797|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Potassium|Change from baseline|Baseline and 52 week after|||mEq/L||Standard Deviation|Mean
73751|NCT01071044|Secondary|Clinical Global Impression (Severity)|The Clinical Global Impression (Severity) is a one-item clinician-rated measure. The item is a likert scale on which the clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.|Every visit|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
73752|NCT01071044|Secondary|Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)|The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
73753|NCT01071044|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|"The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.~Below, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients."|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
73754|NCT01071044|Secondary|Short Form McGill Pain Questionnaire|The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.|Every 2 weeks|All participants were included in analysis.||Scores on a scale||Standard Deviation|Mean
73755|NCT01071044|Secondary|Hamiliton Anxiety Inventory|The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
73756|NCT01071044|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
73757|NCT01071044|Primary|BRIEF-A|The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.|Every 2 weeks|All participants were included in the analysis.||Scores on a scale||Standard Deviation|Mean
73758|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
73759|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 8|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
73760|NCT01070979|Secondary|Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
73761|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
73762|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Hot Flush Count||Standard Error|Least Squares Mean
73763|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Score||Standard Error|Least Squares Mean
73798|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Sodium|Change from baseline|Baseline and 52 week after|||mEq/L||Standard Deviation|Mean
73764|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||Change in Hot Flush Count||Standard Error|Least Squares Mean
73765|NCT01070966|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.|Baseline and up to 5 years|||percentage change||Standard Deviation|Mean
73766|NCT01070966|Primary|Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation|Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.|Up to 14 days after the treatment discontinuation|||Percentage of Participants|||Number
73767|NCT01070953|Primary|Overall Efficacy Evaluation of EZETROL®|Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.|Baseline to 4 weeks|3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded||participants|||Number
73768|NCT01070953|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.|Baseline to 4 weeks|"3,309 subjects were analyzed for the efficacy~evaluation; 227 of the enrolled subjects did not complete the study and were excluded"||percentage of change||Standard Deviation|Mean
73769|NCT01070953|Primary|Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation|Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.|Up to 14 days after treatment discontinuation|||participants|||Number
73770|NCT01070888|Primary|Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide|"Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows:~(max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))"|8 weeks|||percentage of fall in FEV1||Standard Deviation|Mean
73771|NCT01070784|Secondary|Evening FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment|||Liter(L)||Standard Deviation|Mean
73772|NCT01070784|Secondary|Morning FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment|||Liter(L)||Standard Deviation|Mean
73773|NCT01070784|Secondary|Evening Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment|||Liter/minute(L/min)||Standard Deviation|Mean
73774|NCT01070784|Secondary|Morning Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment|||Liter/minute(L/min)||Standard Deviation|Mean
73775|NCT01070784|Secondary|Health Related Quality of Life (HRQL) Based on the St. George’s Respiratory Questionnaire (SGRQ)|The change from run-in period and daily during 52-week randomization treatment average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
73776|NCT01070784|Secondary|Rescue Medication Use|The change from run-in period and daily during 52-week randomization treatment|Daily during 52-week randomization treatment|||innhalation/day||Standard Deviation|Mean
73777|NCT01070784|Secondary|Number of COPD Exacerbations Over the Study Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment|Daily during 52-week randomization treatment|||event|||Number
73778|NCT01070784|Secondary|Time to First COPD Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 52-week randomization treatment|||Percentage of participants|||Number
73779|NCT01070784|Secondary|Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|||percentage of Baseline||Full Range|Geometric Mean
73780|NCT01070784|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|||percentage of Baseline||Full Range|Geometric Mean
73781|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough|There are 5 alternatives (scored 0 to 4, 0= unaware of coughing, 4= never free of cough or need to cough). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment|||units on a scale||Standard Deviation|Mean
73813|NCT01070771|Secondary|To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data.|"This compared the number of vessels in which there was a discrepant result in relation to angiographically and FFR defined significance. Angiographic significance was visually assessed by operators whereas the pressure wire provided objective data as to a narrowing's significance: an FFR reading of <0.8 indicated a significant restriction in blood flow with a recommendation for revascularisation.~The difference in indication for revascularisation of each major coronary artery was also judged according to angiogram alone compared with angiogram plus FFR dtaa."|Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.|||participants|||Number
73814|NCT01070771|Primary|Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG)|This outcome measure was assessing agreement in the management plan (MP) derived from angiographic assessment alone compared to a MP derived from angiographic assessment plus the use of FFR data acquired at the time of angiography. The study assessed the proportion of cases in which the angiogram directed MP changed after FFR data were disclosed.|Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.|||participants|||Number
73815|NCT01070693|Primary|Long-term Sequelae|Any pain at five years|5 years|||percentage of participants|||Number
73816|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
73817|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
73818|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants|||Number
73819|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants|||Number
73820|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of Participants|||Number
74455|NCT01064622|Secondary|Incidence of Adverse Events|Details are provided in Adverse Events section below. Reported here are percentage of patients in each arm with any grade 1 or higher adverse event, regardless of attribution.|Up to 3 years|||percentage of participants||95% Confidence Interval|Number
73821|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants|||Number
73822|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12|RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Week 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|At Week 4 and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.||Participants|||Number
73823|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 12, but no mRVR, Partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Week 12, but no RVR and no cEVR, Modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a.|Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.||Participants|||Number
73824|NCT01070550|Secondary|Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
73825|NCT01070550|Secondary|Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
73826|NCT01070550|Secondary|Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
73827|NCT01070550|Secondary|Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|At Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
73859|NCT01070329|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
73828|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time|Modified virological response is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
73829|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time|Modified virological response was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
73830|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
73831|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
73832|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria. n = the number of participants analyzed at a given time point.||Percentage of participants||95% Confidence Interval|Number
73833|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population. n = the number of participants analyzed at a given time point.||Percentage of participants||95% Confidence Interval|Number
73834|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
73835|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
75781|NCT01048502|Primary|The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).||randomization and 8 weeks post|||pg/mL||Inter-Quartile Range|Median
73836|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.||Percentage of participants||95% Confidence Interval|Number
73837|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of peginterferon alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.||Percentage of participants||95% Confidence Interval|Number
73838|NCT01070394|Secondary|Psychometric Validation of AMSES|To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.|Weeks 0-12|||Cronbach's alpha coefficients|||Number
73839|NCT01070394|Secondary|Psychometric Validation of AMRS|To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.|Weeks 0-12|||Cronbach's alpha coefficients|||Number
73840|NCT01070394|Primary|ADHD-RS|The ADHD-RS is a clinician-administered, semistructured scale that is designed to assess current symtomatology. It consists of 18 items that directly correspond to the DSM-IV symptoms of ADHD and each item is scored on a 4-pt scale ranging from 0 (none) to 3 (severe). It has been standardized to children but has been shown to be sensitive to drug effects in adults with ADHD. Presented will be the change in score of the ADHD-RS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).|12 weeks|||score change from baseline to visit 12||Standard Deviation|Mean
73841|NCT01070394|Secondary|Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist|To correlate symptom rebound throughout a single day (assessed via the AMRS, In Clinic) with a self-assessment of ADHD symptoms (the ASRS v.1.1 Symptom Checklist). Pearson's correlation coefficient will be presented.|Baseline to Week 12|||Pearson's correlation coefficient|||Number
73842|NCT01070394|Secondary|Correlation Between AMRS and TASS|To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented.|Visits 0 and 12|||Pearson's correlation coefficient|||Number
73843|NCT01070394|Secondary|Correlation Between AMRS (In Clinic) and ADHD-RS|To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. The Pearson's correlation coefficients for the In-Clinic assessment will be presented.|Visits 0 and 12|||Pearson's correlation coefficient|||Number
73844|NCT01070394|Secondary|Smoothness of Effect|To evaluate smoothness of effect throughout a single day (assessed via the AMSES) of LDX treatment. Presented will be the change in score of the ADHD-RS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).|Visits 0 and 12|||score change from baseline to visit 12||Standard Deviation|Mean
73845|NCT01070394|Secondary|Symptom Rebound|To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Presented will be the change in score of the AMRS Total Score from baseline to Visit 12 (positive score signifies that the Total Score was greater at baseline than at Visit 12).|Visits 0 and 12|||score change from baseline to visit 12||Standard Deviation|Mean
73846|NCT01070381|Primary|Overall Comfort|Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Units on a Scale||Standard Deviation|Mean
73847|NCT01070329|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline C-SSRS result.||participants|||Number
73848|NCT01070329|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
73926|NCT01069861|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sildenafil Metabolite (UK-103320)||Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73849|NCT01070329|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
73850|NCT01070329|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine|Laboratory assessment of creatinine during the double-blind treatment phase. Normal creatinine ranges for males are 40.00 micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high). Normal creatinine ranges for females are 31.00 µmol/L (low) to 101.00 µmol/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.||participants|||Number
73851|NCT01070329|Other Pre-specified|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."||kilograms (kg)||Standard Error|Least Squares Mean
73852|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
73853|NCT01070329|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."||mm Hg||Standard Error|Least Squares Mean
73854|NCT01070329|Other Pre-specified|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."||beats per minute (bpm)||Standard Error|Least Squares Mean
73855|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
73856|NCT01070329|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.||percentage of participants|||Number
73857|NCT01070329|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result, Last Observation Carried Forward (LOCF).||percentage of participants|||Number
73858|NCT01070329|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
73860|NCT01070329|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
73861|NCT01070316|Primary|Number of Participants Continuing Study Medication Over Time||Individual subjects will be assessed every 6 months for up to 48 months; aggregate analysis will take place at end of study|||participants|||Number
73862|NCT01070316|Primary|Reduction in Seizure Frequency|The primary efficacy endpoint was the percentage of participants demonstrating a 50% or greater reduction in seizure frequency at the end of the maintenance phase (weeks 13-16) compared to baseline (weeks 1-4)|Baseline (Weeks 1-4), Week 16|||percentage|||Number
73863|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 260.||Participants|||Number
73864|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 212.||Participants|||Number
73865|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 152.||Participants|||Number
73866|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 104.||Participants|||Number
73867|NCT01070303|Secondary|Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248|The analysis population is observed cases, that is, all participants who had an IBDQ score at the visit time point.||Scores on a scale||Standard Deviation|Mean
73868|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.||Participants|||Number
73869|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.||Participants|||Number
73870|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.||Participants|||Number
76042|NCT01044706|Primary|AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose)|AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose)|144 hour|per protocol||ng*h/mL||Standard Deviation|Geometric Mean
73871|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.||Participants|||Number
73872|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.||Participants|||Number
73873|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.||Participants|||Number
73874|NCT01070303|Secondary|Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.||Participants|||Number
73875|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.||Participants|||Number
73876|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.||Participants|||Number
73877|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)|CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation Week 212 are included.||Participants|||Number
73878|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in Study to Week 152|The analysis population is observed cases, that is, all participants who CDAI evaluation at Week 152 are included.||Participants|||Number
73879|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 .||Participants|||Number
73880|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.||Participants|||Number
73881|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 212||Participants|||Number
73882|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.||Participants|||Number
73883|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 of Study NCT00055497 are included.||Participants|||Number
73884|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 of Study NCT00055497 are included.||Participants|||Number
73885|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 212|Observed cases, that is, all participants who participating at Week 212 and had a CDAI measurement at that time point were included.||Participants|||Number
73886|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.||Participants|||Number
73887|NCT01070303|Primary|Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 are included.||Participants|||Number
73888|NCT01070173|Primary|Acylated Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.||pg/mL||Standard Deviation|Mean
73889|NCT01070173|Primary|Total Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.||pg/mL||Standard Deviation|Mean
73890|NCT01070043|Secondary|Number of Participants With Adverse Events During Double-blind Phase||8 weeks|Safety population included all patients who received at least one study medication during the study period.||Participants|||Number
73891|NCT01070043|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
73892|NCT01070043|Secondary|Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
73988|NCT01069289|Secondary|Total Number of Day With Exacerbation|Total number of days with COPD exacerbation for each treatment group|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||days|||Number
73893|NCT01070043|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
73894|NCT01070043|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.||mmHg||Standard Deviation|Mean
73895|NCT01069939|Secondary|Number of Participants With Adverse Events|Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.|Up to 70 weeks at the longest|All participants who received any study drug were included in this analysis.||Participants|||Number
73896|NCT01069939|Secondary|Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48|"The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|||Participants|||Number
73897|NCT01069939|Secondary|Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48|"The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of Nausea and/or Vomiting at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
73898|NCT01069939|Secondary|Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week|"The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of abdomen enlarged feeling at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
73899|NCT01069939|Secondary|Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48|"The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of anorexia at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
73900|NCT01069939|Secondary|Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.|"The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of heartburn at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
73901|NCT01069939|Secondary|Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48|"The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of epigastric pain at baseline and post-dose up to 48 weeks were included in this analysis.||Participants|||Number
73902|NCT01069939|Secondary|Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.|Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.|12, 24, 36 and 48 weeks|Patients with endoscopy were included in the analyses at 12, 24, 36 and 48 weeks after randomisation.||Participants|||Number
73903|NCT01069939|Secondary|Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48|Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion.|Up to 48 weeks (Baseline to last measurement)|Participants who had LANZA scores at both baseline and post-dose were included into this analysis.||Scores on a scale||Standard Deviation|Mean
73904|NCT01069939|Primary|Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.|Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.|From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)|Participants not taking investigational drug were not included. In total 364 participants were included in the efficacy evaluation at the interim analysis. 24 of the 364 total participants had an occurrence of gastric and/or duodenal ulcers by the 48-week assessment.||Participants|||Number
92760|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])||Baseline up to Month 7|||percentage of participants|||Number
73905|NCT01069900|Secondary|Bacteriological Response at the End of Treatment (EOT) Visit|Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
73906|NCT01069900|Secondary|Clinical Response at the End-of-Treatment (EOT) Visit|Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
73907|NCT01069900|Secondary|Bacteriological Response at a ‘During Therapy’ Visit|Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
73908|NCT01069900|Secondary|Clinical Response at a ‘During Therapy’ Visit|"Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy.~'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported."|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
73909|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported|28 to 42 days|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
73910|NCT01069900|Secondary|Bacteriological Response at Test-of-Cure (TOC) Visit|"Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate.~'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported."|28 to 42 days|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
73911|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.|28 to 42 days|Safety analysis set with subjects evaluable for this outcome||Percentage of subjects|||Number
73912|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Percentage of subjects|||Number
76043|NCT01044693|Secondary|Change in Heart Rate During the Night|Change from baseline (8 pm) in heart rate at the time of maximal BP-lowering effect|8 pm - 8 am|Participants who completed the 4 treatment arms||bpm||Standard Error|Mean
73913|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Percentage of subjects|||Number
73914|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
73915|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett’s method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
73916|NCT01069900|Secondary|QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
73917|NCT01069900|Secondary|QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QRS interval represents the time it takes for ventricular depolarization to occur. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
73918|NCT01069900|Secondary|RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The RR interval refers to the respective time interval in the Electrocardiogram. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
73919|NCT01069900|Secondary|PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||milliseconds||Standard Deviation|Mean
73920|NCT01069900|Secondary|Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Beats per minute (bpm)||Standard Deviation|Mean
73921|NCT01069900|Secondary|Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term|"Musculoskeletal adverse events were classified as following SOCs (preferred terms): injury, poisoning and procedural complications (forearm fracture, joint injury, ligament sprain, muscle strain) musculoskeletal and connective tissue disorders (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms."|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Percentage of subjects||95% Confidence Interval|Number
73922|NCT01069900|Primary|Number of Subjects With Musculoskeletal Adverse Events||All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Subjects|||Number
73923|NCT01069900|Primary|Number of Subjects With Clinical Cardiac Adverse Events||Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Subjects|||Number
73924|NCT01069900|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.||Subjects|||Number
73925|NCT01069861|Other Pre-specified|Duration of Study Medication|The duration of the infusion was determined as per investigator’s discretion up to Day 7 or Day 14.|Baseline up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73927|NCT01069861|Secondary|Population Pharmacokinetics of Sildenafil|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion||||||
73928|NCT01069861|Secondary|Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO])|Time from start of treatment up to introduction of standard therapy. If participants did not receive standard therapy within 14 days after initiation of the study treatment, then Day 14 was the censoring time.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73929|NCT01069861|Secondary|Duration of Mechanical Ventilation|The number of days from the start to the stop of mechanical ventilation, if multiple ventilations occurred during the follow-up, the sum of the duration of each ventilation was used for analyses. Mechanical ventilation was defined as use of mechanical assistance or replacement of spontaneous breathing.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73930|NCT01069861|Secondary|Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to the Fraction of Inspired Oxygen (P/F) at Hour 6 and 12|The ratio of partial pressure of arterial oxygen and fraction of inspired oxygen is a comparison between the oxygen level in the arterial blood and the oxygen concentration that is breathed. It helps to determine the degree of any problems with how the lungs transfer oxygen to the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73931|NCT01069861|Secondary|Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 12|Differential oxygenation saturation between preductal and postductal sites as measured by pulse oximetry. A difference of greater than (>) 5 percent (%) to 10% in saturation indicates right-to-left shunt through the ductus arteriosus. Oxygenation saturation is measured as percentage of hemoglobin binding sites occupied by oxygen in the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73932|NCT01069861|Secondary|Change From Baseline in Oxygenation Index at Hour 6 and 12|Oxygenation Index (OI) was calculated as the product of fraction of inspired oxygen (FiO2) and Mean Airway Pressure divided by partial pressure of oxygen in arterial blood [(FiO2*Mean Airway Pressure)/PaO2] measured in centimeter of water/millimeter of mercury (cmH2O/mmHg). FiO2 is the measure of oxygen concentration that is breathed. Mean airway pressure is defined as an average of the airway pressure throughout the respiratory cycle. PaO2 is the measure of oxygen level in the arterial blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73933|NCT01069861|Primary|Number of Participants With Abnormal Laboratory Data|Criteria for potentially clinically significant (PCS) laboratory values: hematocrit 29.2 percent (%); white blood cell (WBC) count 5.0*10^3, lymphocyte absolute 0.88*10^3, total neutrophils absolute 12.07*10^3, eosinophils absolute 0.50*10^3 per cubic millimeter (/mm^3); calcium 6.8 milligram/deciliter (mg/dL); venous bicarbonate 47.0 milliequivalent/liter (meq/L).|Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14)|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73934|NCT01069861|Primary|Number of Participants With Adverse Events (AEs) Based on Severity|AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE:AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent/significant disability/incapacity; congenital anomaly. Severity criteria: “mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function and severe=interferes significantly with participant's usual function”.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73935|NCT01069861|Primary|Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO)|Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment.|From start of infusion (baseline) up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.|||||
73936|NCT01069627|Secondary|Time to Overall Response of CR or PR - Time to Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; only participants with a response of CR or PR were included in the analysis.||days||Standard Deviation|Mean
73937|NCT01069627|Secondary|Time to Overall Response of CR or PR - Percentage of Participants With an Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
74080|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18)|Week 26|Full Analysis Set (FAS) includes all randomised subjects. For 29 subjects, values were missing.||Subjects|||Number
73938|NCT01069627|Secondary|Time to CR - Time To Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis.||days||Standard Deviation|Mean
73939|NCT01069627|Secondary|Time to CR - Percentage of Participants With an Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
73940|NCT01069627|Secondary|TTF - Time to Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than ‘Protocol Violation’ or ‘Administrative Problem’. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||days||95% Confidence Interval|Median
73941|NCT01069627|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than ‘Protocol Violation’ or ‘Administrative Problem’. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
73942|NCT01069627|Secondary|OS - Time to Event|The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population||days||95% Confidence Interval|Median
73943|NCT01069627|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population||percentage of participants|||Number
73944|NCT01069627|Secondary|Duration of Stable Disease - Time to Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the analysis.||days||95% Confidence Interval|Median
73945|NCT01069627|Secondary|Duration of Stable Disease - Percentage of Participants With an Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the anlaysis.||percentage of participants|||Number
73946|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Time to Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.||days||95% Confidence Interval|Median
73947|NCT01069627|Primary|Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)|The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants||95% Confidence Interval|Number
73948|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Percentage of Participants With an Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.||percentage of participants|||Number
73989|NCT01069289|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter/minute (L/min)||Standard Deviation|Mean
73949|NCT01069627|Secondary|Duration of CR - Time to Event|The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis||days||95% Confidence Interval|Median
73950|NCT01069627|Secondary|Duration of CR - Percentage of Participants With an Event|Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR were included in the analysis.||percentage of participants|||Number
73951|NCT01069627|Secondary|TTP - Time to Event|TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||days||95% Confidence Interval|Median
73952|NCT01069627|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants|||Number
73953|NCT01069627|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form and were assigned a study patient number; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.||percentage of participants||95% Confidence Interval|Number
73954|NCT01069562|Secondary|INTRA OPERATIVE PHENYLEPHRINE USED|The amount of phenylephrine used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||.µg/kg||Standard Deviation|Mean
73955|NCT01069562|Secondary|Intra Operative Adrenaline Used|The amount of adrenaline used during the procedure|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||µg/kg||Standard Deviation|Mean
73956|NCT01069562|Secondary|Fentanyl Used|The total amount of fentanyl that was used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||µg/kg||Standard Deviation|Mean
73957|NCT01069562|Secondary|Intra-operative Awareness|The number of patients who were able to recall the intra-operative events when assessed postoperatively. This was assessed by a structured protocol|3 days (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||participants|||Number
73958|NCT01069562|Secondary|Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of time||Standard Deviation|Mean
73959|NCT01069562|Secondary|Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline|The duration of time heart rate remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of time||Standard Deviation|Mean
73960|NCT01069562|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of BIS||Standard Deviation|Mean
73961|NCT01069562|Secondary|Median Absolute Performance Error (MDAPE)|The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage deviation of absolute BIS||Standard Deviation|Mean
73990|NCT01069289|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter/minute (L/min)||Standard Deviation|Mean
73962|NCT01069562|Secondary|Median Performance Error (MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either ‘+’ or ‘_’ indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during isoflurane anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage deviation of BIS from target||Standard Deviation|Mean
73963|NCT01069562|Primary|Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50|The duration of time depth of anesthesia was maintained in the recommended range (as measured by BIS) during the period isoflurane (general anesthetic) was administered to the study population. This value expressed as percentage is the primary outcome. BIS is an objective measure of depth of anesthesia derived from statistical(bispectral) analysis of electroencephalographic waves. BIS ranges from 0 to 100. It decreases monotonically from 100 in the awake state to lower values with sedation and anesthesia.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis||percentage of time||Standard Deviation|Mean
73964|NCT01069523|Secondary|Clinical Global Impression- Improvement|Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse|Week 4 of study|||units on a scale||Standard Deviation|Mean
73965|NCT01069523|Primary|Dupaul ADHD Rating Scale|54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.|Baseline and Follow up|||units on a scale||Standard Deviation|Mean
73966|NCT01069484|Secondary|Urinary Incontinence (Positive Pad Test)|"Urinary incontinence assessed by pad test, as described by Mørkved and Bø (1997). The cutoff value for a positive test was 2 gram.~After voiding, the women drank one litre of water. Thirty minutes later they wore a pre-weighted pad and performed a stress test as follows:~Jumping up and down with maximal intensity for 30 seconds.~Jumping with the legs in alternate abduction and adduction (Jumping Jacks) with maximal intensity for another 30 seconds.~Coughing as hard as possible three times. As in the study by Mørkved and Bø (1997), a positive pad-test was set to a cut-off of 2 gram of leakage."|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.||participants|||Number
73967|NCT01069484|Primary|Urinary Incontinence (Prevalence)|Urinary incontinence was assessed by The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form questionnaire, www.iciq.net). Women were considered as incontinent if they reported to leak urine (yes/no) at any frequency.|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.||participants|||Number
73968|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)|"The CDAI was calculated with the equation:~CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient’s Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician’s Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104)."|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||units on a scale||Standard Deviation|Mean
73969|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||units on a scale||Standard Deviation|Mean
73970|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)|Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||units on a scale||Standard Deviation|Mean
73991|NCT01069289|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||event|||Number
76084|NCT01043939|Secondary|Change in Myeloperoxidase (MPO)|Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress|4 weeks|||ng/mL||95% Confidence Interval|Geometric Mean
73971|NCT01069419|Primary|Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6|"The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient’s Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints.~For the analysis, DAS28 values were categorized into the following groups:~DAS28 < 2.6: clinical remission~DAS28 from 2.6 to ≤ 3.2: low disease activity~DAS28 from > 3.2 to 5.1: moderate disease activity~DAS28 > 5.1: high disease activity"|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Non-Responder Imputation (NRI). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.||percentage of participants||95% Confidence Interval|Number
73972|NCT01069341|Secondary|Mean Change in Intraocular Pressure (IOP)|Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.|at months-3,7, and 12|All subjects' data was analyzed, no subjects were excluded||mmHg||Standard Deviation|Mean
73973|NCT01069341|Secondary|Mean Number of PRP Laser Treatments|Mean number of PRP laser treatments required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded||PRP Laser treatments||Standard Deviation|Mean
73974|NCT01069341|Secondary|Mean Number of Ranibizumab Injections|Mean number of ranibizumab injections required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded||Number injections||Standard Deviation|Mean
73975|NCT01069341|Secondary|Mean Time to Re-treatment|Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)|first 12 months|All subjects' data was included||months||Standard Deviation|Mean
73976|NCT01069341|Secondary|Macular Volume|Macular volume (millimeters cubed [mm3]) by Stratus OCT|at months-1,3,7, and 12|All subjects' data was analyzed, no subjects were excluded||Macular volume (millimeters cubed)||Standard Deviation|Mean
73977|NCT01069341|Secondary|Presence of Proliferative Diabetic Retinopathy (PDR)|Presence of proliferative diabetic retinopathy by fluorescein angiogram|at month-12|All subjects' data was analyzed, no subjects were excluded||participants|||Number
73978|NCT01069341|Secondary|Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)|Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12|months 3, 7 and 12|All subjects' data was analyzed, no subjects were excluded||participants|||Number
73979|NCT01069341|Primary|Adverse Event (AE)|Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).|first 12 months|All subjects' data was analyzed, no subjects were excluded||participants|||Number
73980|NCT01069289|Secondary|St George’s Respiratory Questionnaire (SGRQ) Total Score|The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
73981|NCT01069289|Secondary|Use of Rescue Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||inhalations/day||Standard Deviation|Mean
73982|NCT01069289|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
73983|NCT01069289|Secondary|Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
73984|NCT01069289|Secondary|Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||units on a scale||Standard Deviation|Mean
73985|NCT01069289|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Nights with symptoms||Standard Deviation|Mean
73986|NCT01069289|Secondary|Evening Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter (L)||Standard Deviation|Mean
73987|NCT01069289|Secondary|Morning Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||Liter (L)||Standard Deviation|Mean
73992|NCT01069289|Secondary|Percentage of Participants With Exacerbations|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of participants|||Number
73993|NCT01069289|Secondary|1 Hour Post-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
73994|NCT01069289|Secondary|Pre-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
73995|NCT01069289|Secondary|1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
73996|NCT01069289|Primary|Pre-dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.||percentage of Baseline||Full Range|Geometric Mean
73997|NCT01069172|Secondary|Cumulative Dissipated Energy (CDE)|"CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:~CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)~0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification."|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of CDE was done by eye group.||CDE||Standard Deviation|Mean
73998|NCT01069172|Primary|Deviation From Intended Capsulotomy Diameter|Capsulotomy diameter measured during surgery for both the experimental and control groups.|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of capsulotomy size was done by eye group.||μm||Standard Deviation|Mean
73999|NCT01069120|Primary|To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)||During two 4 month treatment periods||||||
74000|NCT01069003|Primary|Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)|||Percentage of participants|||Number
74001|NCT01069003|Primary|Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects|"All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC)~Definite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers~Probable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause"|Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)|||percentage of participants|||Number
74002|NCT01069003|Primary|Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)|||Percentage of participants|||Number
74003|NCT01068964|Primary|The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4|The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.|Baseline, Week 4|Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
74004|NCT01068912|Primary|Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza|"Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. Alleviated was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours."|22 weeks|The primary analysis population for efficacy analyses was the ITTI Population (N=333), defined as all patients who received at least 1 dose of study drug with any available efficacy data after randomization and who tested positive for influenza A or B by PCR assay or culture tests on Day 1 using determinations.||hours||95% Confidence Interval|Median
74005|NCT01068860|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks|An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline, 4 weeks|Safety Population consisted of all participants who received at least one dose of study medication and had at least one post-baseline safety assessment.||participants|||Number
74006|NCT01068860|Secondary|Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks|"Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||nmol/L||Standard Error|Least Squares Mean
74007|NCT01068860|Secondary|Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks|Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/L||Standard Error|Least Squares Mean
74008|NCT01068860|Secondary|Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks|"Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
74009|NCT01068860|Secondary|Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol*hr/L||Standard Error|Least Squares Mean
74010|NCT01068860|Secondary|Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||nmol*hour/L||Standard Error|Least Squares Mean
74011|NCT01068860|Secondary|Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol*hour/L||Standard Error|Least Squares Mean
74012|NCT01068860|Secondary|Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks|"Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
74013|NCT01068860|Secondary|Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks|GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||number||Standard Error|Least Squares Mean
74023|NCT01068769|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever comes first. Progression is evaluated every 8 weeks using Response Criteria for Solid Tumors (RECIST) 1.1. Objective disease progression is defined as a 20% increase in the sum of the longest diameter of target lesion(s).|From date of enrollment until date of first documented progression or date of death from any cause, whichever came first|||months||95% Confidence Interval|Median
74014|NCT01068860|Secondary|Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks|"The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||number||Standard Error|Least Squares Mean
74015|NCT01068860|Secondary|Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks|"Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/L||Standard Error|Least Squares Mean
74016|NCT01068860|Secondary|Mean Change in Fructosamine, From Baseline to 4 Weeks|"Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
74017|NCT01068860|Secondary|Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks|"Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||mmol/L||Standard Error|Least Squares Mean
74018|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
74019|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
74020|NCT01068860|Primary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
74021|NCT01068821|Secondary|Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery|The neurologic deficit was assessed as follows: Patients' postoperative care was unchanged from routine for this study. Any postoperative complaints regarding limb pain or weakness or numbness were recorded and assessed with neurologic exam to determine sensation or motor components. Absence of resolution was documented.|postoperative day 1 and postoperative week 3-8|Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed)||participants|||Number
74022|NCT01068821|Primary|Amount of Patient Movement on the Operating Room Table|Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.|About 150 minutes after start of surgery|Study size calculation was performed for 80% power, and p=0.05||centimeters||Standard Deviation|Mean
74036|NCT01068743|Primary|Metformin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
74024|NCT01068769|Primary|Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control|The composite of complete response, partial response, and stable disease lasting 16 weeks or more per RECIST 1.1 as a measure of disease control. This is for target lesions. Complete response is disappearance of all target lesions and partial response is >+30% decrease in the sum of the longest diameter of target lesions. Stable disease is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions. Progressive disease is considered an increase of the sum of the longest diameter of target lesions by greater than or equal to 20%.|2 years|||percentage of participants||95% Confidence Interval|Number
74025|NCT01068743|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities that were considered clinically significant and/or reported as an AE by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.||participants|||Number
74026|NCT01068743|Other Pre-specified|Metformin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||hr||Standard Deviation|Mean
74027|NCT01068743|Other Pre-specified|Metformin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||hr||Standard Deviation|Mean
74028|NCT01068743|Other Pre-specified|Metformin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74029|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||hr||Standard Deviation|Mean
74030|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||hr||Standard Deviation|Mean
74031|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74032|NCT01068743|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs).|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.||participants|||Number
74033|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||hr||Standard Deviation|Mean
74034|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||hr||Standard Deviation|Mean
74035|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74037|NCT01068743|Primary|Metformin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74038|NCT01068743|Primary|Saxagliptin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
74039|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
74040|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74041|NCT01068743|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74042|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74043|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
74044|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
74045|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
74046|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, T 1/2 was not analysed for 1 participant who did not have a clear terminal elimination phase.||hr||Standard Deviation|Mean
74047|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.||hr||Standard Deviation|Mean
74048|NCT01068730|Secondary|Participants With Abnormal Vital Sign Findings Reported as an AE|per investigator|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
74049|NCT01068730|Secondary|Participants With Abnormal Physical Findings|Physical findings that were considered abnormal by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
74050|NCT01068730|Secondary|Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
76085|NCT01043939|Secondary|Change in Oxidized LDL|Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress|4 weeks|||Units/Liter||Standard Error|Least Squares Mean
74051|NCT01068730|Secondary|Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.||Participants|||Number
74052|NCT01068730|Primary|Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
74053|NCT01068730|Primary|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, AUC (0-inf) was not analysed for 1 participant who did not have a clear terminal elimination phase.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
74054|NCT01068717|Primary|Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||Hours||Full Range|Median
74055|NCT01068717|Primary|AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
74056|NCT01068717|Primary|AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
74057|NCT01068717|Primary|AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
74058|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate|Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.|At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.|All enrolled participants who received study medication.||Participants|||Number
74059|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|At screening visit, Day -1 of Period 1, and at study discharge|All enrolled participants who received study medication.||Participants|||Number
74060|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results|Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.|At screening visit, at Day -1 of Periods 1 through 4, and at discharge|All enrolled participants who received study medication.||Participants|||Number
74061|NCT01068717|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4|All enrolled participants who received study medication.||Participants|||Number
74062|NCT01068717|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
74063|NCT01068717|Primary|Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||Hours||Standard Deviation|Mean
74064|NCT01068717|Primary|Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
74065|NCT01068717|Primary|Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
74066|NCT01068678|Secondary|Change in Body Weight|Change from baseline in body weight after week 26|Week 26|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.||kg||Standard Deviation|Mean
74067|NCT01068678|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after week 26|Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74068|NCT01068665|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.||mmol/L||Standard Deviation|Mean
74069|NCT01068665|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). 2 subjects were withdrawn prior to exposure to the study drug in the IDeg arm as they were randomised in error and 1 subject in the IGlar arm.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74070|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment|Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32)|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
74071|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment|Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25)|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
74072|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment|Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18)|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
74073|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment|Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11)|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mg/dL||Standard Deviation|Mean
74074|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment|Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
74075|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment|Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
74076|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment|Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
74077|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment|Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 28 subjects, PG (mg/dL) increment values were missing at all evaluations.||mg/dL||Standard Deviation|Mean
74078|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32)|Week 50|Full Analysis Set (FAS) includes all randomised subjects. For 35 subjects, values were missing.||Subjects|||Number
74079|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)|Week 38|Full Analysis Set (FAS) includes all randomised subjects. For 31 subjects, values were missing.||Subjects|||Number
80283|NCT00998296|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|First treatment administration until cut-off date of 02 October 2014, up to 336 days|TS||participants|||Number
74081|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11)|Week 14|Full Analysis Set (FAS) includes all randomised subjects. For 20 subjects, values were missing.||Subjects|||Number
74082|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Week 50|Observed mean change from baseline in HbA1c at Week 50 (visit 32)|Week 0, Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74083|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 38 (visit 25)|Week 0, Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74084|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Observed mean change in from baseline in HbA1c at Week 26 (visit 18)|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74085|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 14 (visit 11)|Week 0, Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74086|NCT01068652|Primary|Glycosylated Haemoglobin (HbA1c)|Estimated mean difference in HbA1c after 50 weeks of treatment|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, HbA1c values were missing.||percentage of glycosylated haemoglobin||Standard Error|Mean
74087|NCT01068626|Secondary|Change in LDL||6 months|||mmol/L||Standard Deviation|Mean
74088|NCT01068626|Secondary|Change in Body Weight||6 months|||kg||Standard Deviation|Mean
74089|NCT01068626|Secondary|Change in Hepatic Fat Infiltration Measured by CT.||6 months|||Hounsfield units||Standard Deviation|Mean
74090|NCT01068626|Secondary|Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.||6 months|||ratio||Standard Deviation|Mean
74091|NCT01068626|Secondary|Change in Subcutaneous Adipose Tissue Area||6 months|||cm2||Standard Deviation|Mean
74092|NCT01068626|Primary|Change in Visceral Adipose Tissue Area Measured by Computed Tomography.||6 months|Per protocol||cm2||Standard Deviation|Mean
74093|NCT01068600|Secondary|Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study medication. If data were missing or insufficient for any one of the domains a focal score was not calculated. Missing focal scores after week 4 were imputed using last observation carried forward.||Score on a scale||Standard Error|Least Squares Mean
74094|NCT01068600|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data was imputed using last observation carried forward.||Liters||Standard Error|Least Squares Mean
74095|NCT01068548|Secondary|Time to Change to Oral Antibiotics||1 month||||||
74096|NCT01068548|Primary|Length of Hospital Stay||1 month|||Days||Standard Deviation|Mean
74097|NCT01068509|Secondary|Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104|Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Arbitrary units||Standard Deviation|Mean
74098|NCT01068509|Secondary|Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104|Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Arbitrary units||Standard Deviation|Mean
74099|NCT01068509|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 4 years 10 months)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Months||95% Confidence Interval|Median
74112|NCT01067976|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
74100|NCT01068509|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.|Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.||Months||95% Confidence Interval|Median
74101|NCT01068418|Secondary|The Renal Blood Flow Response to Angiotensin II|The difference in the change in renal plasma flow in response to an exogenous infusion of angiotensin II was measured before and after intervention with vitamin D3 therapy.|1 month of intervention|||mL/min/1.72m2||Standard Deviation|Mean
74102|NCT01068418|Primary|The Blood Pressure Response to Angiotensin II|The difference in the change in mean arterial pressure in response to an exogenous infusion of angiotensin II was measured before and after intervention with vitamin D3 therapy.|1 month of intervention|||mmHg||Standard Deviation|Mean
74103|NCT01068158|Secondary|Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 2 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-Treat (Safety) population.||Participants|||Number
74104|NCT01068158|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Adverse events were defined and classified as follows:~'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 2 up to Day 15 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Participants|||Number
74105|NCT01068158|Primary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat 2 (All Participants) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
74106|NCT01068158|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in a subset of the Intent-to-treat population (Index participants). Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
74107|NCT01067976|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow–up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||participants|||Number
74108|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||beats/min||Standard Deviation|Mean
74109|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.||mmHg||Standard Deviation|Mean
74110|NCT01067976|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||Kappa|Participants||Number
74111|NCT01067976|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure||Kappa|Participants||Number
74113|NCT01067976|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Categorical Accuracy Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.||kappa|Participants||Number
74114|NCT01067976|Other Pre-specified|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Majority Reader, Participant Level|The 3 blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1=not confident, 2=somewhat confident, 3=confident, and 4=very confident). The majority read value for the 3 readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers, i.e. multifocal. For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. value respectively. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments by the majority reader for both modalities in the comparison for this assessment. Majority reader results are based on the average of the 3 blinded readers’s assessment.||difference of scores on a scale|Participants|90% Confidence Interval|Mean
74115|NCT01067976|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Majority Reader, Participant Level|The disease state “bilateral malignant disease” was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region, the assessment of bilateral malignant disease was categorized as “No”. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as “Yes”. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease was derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on 388 participants; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.||difference in accuracy (%)||95% Confidence Interval|Mean
74116|NCT01067976|Other Pre-specified|Sensitivity Difference of Detection of Multicentric Malignant Disease Verified by SoT by Majority Reader, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on a total number of 53 evaluable breasts with multicentric malignant disease.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
74117|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Single examination|For multifocal malignant disease, specificity analyses were based on a total number of 3816 regions, 390 participants in FAS.||difference in specificity (%)|Participants|95% Confidence Interval|Mean
74118|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, specificity analyses were based on a total number of 3307 regions (i.e. regions with no disease or multifocal malignant disease), 390 participants in FAS.||difference in specificity (%)|Participants|95% Confidence Interval|Mean
74137|NCT01067768|Primary|Rate of Catheter-associated Urinary Tract Infection||Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)|Analysis by intention to treat||infections per 1000 days||95% Confidence Interval|Number
74138|NCT01067716|Other Pre-specified|Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power||1 Year|||percentage of eyes|Participants|95% Confidence Interval|Number
74119|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3240 regions, 390 participants in FAS.||difference in specificity (%)|Participants|95% Confidence Interval|Mean
74120|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For multifocal malignant disease, sensitivity analyses were performed for a total number of 67 regions.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
74121|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, sensitivity analyses were performed for a total number of 576 regions (i.e. regions with unifocal disease verified by SoT), 390 participants in FAS.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
74122|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 643 regions, 390 participants in FAS. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions.||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
74123|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 1120 regions, 390 participants from FAS.||percent difference|Participants|95% Confidence Interval|Mean
74124|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3883 regions, 390 participants in FAS.||percent difference|Participants|95% Confidence Interval|Mean
74125|NCT01067976|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N–FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with or without malignant disease verified by SoT for which assessment by the imaging modality were available.||specificity (%)||95% Confidence Interval|Mean
74126|NCT01067976|Secondary|Percentage Difference of Participants Whose Additional Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 87 participants in FAS who had at least one additional cancer region according to SoT.||difference in percentage of participants||95% Confidence Interval|Number
74127|NCT01067976|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 382 participants in FAS. Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.||difference in percentage of participants||95% Confidence Interval|Number
74128|NCT01067976|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as false positive (FP), when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as true negative (TN). Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.||specificity (%)||95% Confidence Interval|Mean
74129|NCT01067976|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 372 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SOT).||specificity (%)||95% Confidence Interval|Mean
74130|NCT01067976|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).||sensitivity %||95% Confidence Interval|Mean
74131|NCT01067976|Primary|Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).||difference in sensitivity (%)||95% Confidence Interval|Mean
74132|NCT01067846|Primary|Treatment Retention – Number of Visits During Treatment|Number of treatment visits attended prior to discontinuation of treatment|Treatment sessions included 3 visits per week for 4 weeks|Total possible sessions attended = 180 per arm. Some participants did not complete all sessions, therefore the units analyzed will not match the total possible.||visits|Participants|Standard Deviation|Mean
74133|NCT01067846|Primary|Drug Abstinence During Treatment and at Follow up Visits|Percentage of the overall number of drug abstinences of participants measured by urine drug testing|Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit|Total possible urine samples = 225 per arm. Not all participants stayed in treatment, therefore the total units analyzed will not match the total possible.||percentage of drug abstinences|Participants||Number
74134|NCT01067781|Secondary|Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: (1) Geometric Mean Titers (2) Geometric Mean Fold Ratios (3) Seroconversion Rates||Day 0 to Day 180||||||
74135|NCT01067781|Primary|Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs|Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.|Day 0 to Day 180|||participants|||Number
74136|NCT01067768|Secondary|Catheter Days|The duration of catheterization|withdrawal of the catheter|Analysis by intention to treat||Days||Inter-Quartile Range|Median
74139|NCT01067716|Other Pre-specified|Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)|After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).|1 Year|||percentage of eyes|Participants|95% Confidence Interval|Number
74140|NCT01067716|Other Pre-specified|Percent Manifest Refraction Spherical Equivalent Within 1.0D|Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.|1 Year|As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.||percentage of eyes|Participants|95% Confidence Interval|Number
74141|NCT01067716|Primary|Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||1 Year|As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.||percentage of eyes|Participants|95% Confidence Interval|Number
74142|NCT01067456|Secondary|To Compare the Cost of Care Between the Comprehensive Cardiothoracic CT Arm and the Dedicated Aortic Dissection/Acute Coronary Syndrome/Pulmonary Embolism CT Protocol (Standard of Care) Arm||Index Hospitalization||||||
74143|NCT01067456|Primary|Length of Hospital Stay||up to 1 week|||Hours||Inter-Quartile Range|Median
74144|NCT01067352|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug , SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|Baseline through Week 96|Safety analysis population included all randomized participants with at least 1 post-baseline assessment.||participants|||Number
74145|NCT01067352|Secondary|Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth|Spontaneous catch up growth was the growth shown by SGA participants having length more than third percentile at Week 96 without any study drug treatment.|Baseline through Week 96|Data was not analyzed due to small number of evaluable participants.|||||
74146|NCT01067352|Primary|Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children|Gene expression profiling:analysis of ribonucleic acid (RNA) extracted from body tissue or fluids using Clontech Atlas Human Array to study level of activation of genes in tissue analyzed. Analysis was performed to identify possible correlation between catch-up growth (either spontaneous or drug-induced after Week 48) and therapeutic response to rhGH. Spontaneous catch up growth:shown by SGA participants having length more than third percentile at Week 96 without any treatment;drug induced growth was by SGA participants having length more than third percentile at Week 96 with drug treatment.|Baseline and Week 48|Gene expression profiling was not performed due to RNA degradation in nearly all of the blood samples and hence no comparison between gene expression and growth was made.|||||
74147|NCT01067326|Primary|Reactive Hyperemia Index (RHI)|"RHI was measured by the noninvasive endothelial peripheral arterial tomography (EndoPat) test. EndoPAT results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|Baseline, 4 Months|||units on a scale||Inter-Quartile Range|Median
74148|NCT01067326|Secondary|Diastolic Blood Pressure||Baseline, 4 Months|||mm Hg||Standard Deviation|Mean
74149|NCT01067326|Secondary|Systolic Blood Pressure||Baseline, 4 Months|||mm Hg||Standard Deviation|Mean
74150|NCT01067326|Primary|Endothelial Progenitor Cells (EPC)|Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.|Baseline, 4 Months|||counts per 100,000 gated events||Inter-Quartile Range|Median
74151|NCT01067105|Secondary|Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey|Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.|Weeks 6 and 12|Intent to Treat Population||participants|||Number
74152|NCT01067105|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population||percentage of devices|||Number
74153|NCT01067105|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population||devices|||Number
74154|NCT01067105|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population||percentage of devices|||Number
74155|NCT01067105|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population.||devices|||Number
74156|NCT01067105|Secondary|Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances|Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.|Weeks 0-12|Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses.||percentage of correct advances||Standard Deviation|Mean
74172|NCT01066871|Secondary|Number of Participants With Global Evaluation of Treatment Benefit|Participants were asked to evaluate and rate the treatment benefit as poor, fair, good, very good or excellent.|Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||participants|||Number
74157|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
74158|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, and 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
74159|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
74160|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.||units on a scale||Standard Deviation|Mean
74161|NCT01067105|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
74162|NCT01067105|Primary|Percentage of Subjects Who Discontinue Due to AEs.||Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
74163|NCT01067105|Primary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs)||Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
74164|NCT01067105|Primary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 1-26|Intent to Treat Population||percentage of participants|||Number
74165|NCT01066923|Secondary|Hyperthermia and Hemoconcentration Identified by Retinal Imaging|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise||||||
74166|NCT01066923|Secondary|Activation of Coagulation|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise||||||
74167|NCT01066923|Primary|Vascular Function Measured by Peripheral Arterial Tonometry|Reactive Hyperemia Index|Baseline, 30, 60, and 90 minutes post exercise|||ratio (Reactive Hyperemia Index)||Standard Deviation|Mean
74168|NCT01066923|Primary|Platelet Closure Time||0, 30, 60, and 90 minutes post exercise|||seconds||Inter-Quartile Range|Median
74169|NCT01066871|Secondary|Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18)|Number of participants with BAbs and NAbs to FGF18 at Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 were reported.|Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.||participants|||Number
74170|NCT01066871|Secondary|Number of Participants With Acute Inflammatory Reactions|Acute inflammatory reaction (AIR) is defined as an increase of pain by 30 millimeter (mm) on a 100 mm visual analog scale (VAS) associated with a subject-reported synovial fluid effusion within 3 days following intra-articular injection.|Baseline up to Month 12|"Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."||participants|||Number
74171|NCT01066871|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An SAE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are those AEs that either started or worsened in severity on or after the date of first dose of study drug and on or before Month 12. Local TEAEs are those only related to the target knee. Systemic TEAEs are those that are related to other parts of the body.|Baseline up to Month 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.||participants|||Number
74603|NCT01062425|Secondary|Incidence of Grade 3+ Toxicities|The number of patients with reported grade 3 and higher treatment-related toxicities as assessed by Common Terminology Criteria for Adverse Events version 4.0|From randomization to six months.|All randomized and eligible patients who started protocol treatment.||participants|||Number
74173|NCT01066871|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12|The KOOS is a knee-specific self-administered questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It consists of 42 items grouped into 5 sub-scales: symptoms, pain, function in daily living (FDL), function in sports and recreation activities (FSRA), and quality of life (QoL). Sub-scale scores range from 0-100, with 0 representing extreme knee problems and 100 no knee problems. The IKDC consists of 19 items to summarize symptoms such as highest level of activity without significant pain, frequency and severity of pain scales, stiffness and swelling, highest levels of activity without significant swelling or giving way, knee lock or catch, highest level of activity that can be performed on a regular basis, effect of knee on ability to perform set tasks, knee function prior to injury, and current knee function. The IKDC scores range from 0-100 where high score represents high levels of function.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||units on a scale||Standard Deviation|Mean
74174|NCT01066871|Secondary|Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12|The ICRS grading is used to score the amount of cartilage repair and damage. The grades range from 1 to 4 where higher grades indicate more severity of injury. Number of participants with change value of -3, -2, -1, 0, 1, and 2 from baseline in ICRS grade at Months 6 and 12 were reported. Lower change value indicates less severity of injury.|Baseline, Months 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||participants|||Number
74175|NCT01066871|Secondary|Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Total number of participants with shift from baseline in various BLOKS sub-scales (cartilage 1 [patella medial, patella lateral, femur medial trochlea, femur lateral trochlea, medial weight bearing femur, lateral weight bearing femur, tibia medial, tibia lateral], synovitis, and effusion) scores at Month 12 were reported.|Month 12|The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment.||participants|||Number
74176|NCT01066871|Secondary|Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Change from baseline in summary scores for BML size, osteophyte size, MES, and MTS were reported. Summary scores for BML size range from 0 to 27, for osteophyte size range from 0 to 36, for MES range from 0 to 12, and for MTS range from 0 to 32, with lower scores corresponding to favorable outcomes.|Baseline, Month 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||units on a scale||Standard Deviation|Mean
74177|NCT01066871|Secondary|Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales|MOCART scoring system (comprising 9 variables) was used to describe the morphology & signal intensity of the repair tissue following MRI -degree of defect repair [DDR] score 0 (subchondral bone exposed) to 20 (complete repair); integration to the border zone [IBZ] score 0 (> 50% of length of repair tissue) to 15 (complete integration to border zone);surface of repair tissue [SRT] score 0 (>50% surface repair tissue/total degradation) to 10(surface intact);structure of repair tissue [StRT] score 0(inhomogenous/cleft formation) to 5 (homogenous);signal intensity [T2] Mapping Sequence [T2MS] and Hi-Res Sagittal Pharmacodynamic Sequence [Hi-Res SPS] score 0 (marked hyper intense for T2MS and hypo intense for Hi-Res SPS) to 15 (iso intense); subchondral lamina,subchondral bone score 0 (not impact) to 5 (intact);adhesions & effusion score 0 (yes) and 5 (no). Higher values represent more favorable outcome of repair.|Months 3 (M3), 6 (M6) and 12 (M12)|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||participants|||Number
74178|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12|The change in cartilage defect thickness at Months 3, 6 and 12 based on central MRI was calculated as thickness at Months 3, 6 and 12 minus thickness at baseline, respectively.|Baseline, Months 3, 6 and 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||millimeter||Standard Deviation|Mean
74179|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12|The change in cartilage defect volume at Months 3, 6 and 12 based on central MRI was calculated as volume at Months 3, 6 and 12 minus volume at baseline, respectively.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||microliter||Standard Deviation|Mean
74180|NCT01066871|Secondary|Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6|Percent change in cartilage defect volume and cartilage defect thickness at Months 3 and 6 based on central MRI was calculated as: ([volume or thickness at Months 3 and 6 minus volume or thickness at baseline, respectively]*100)/volume or thickness at baseline.|Baseline, Months 3 and 6|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."||Percent change||Standard Deviation|Mean
74648|NCT01061671|Secondary|Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)||up to 37 months|Analysis excludes participants without any follow-up data.||events per patient year||95% Confidence Interval|Mean
74181|NCT01066871|Primary|Percent Change From Baseline in Cartilage Defect Volume at Month 12|Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)*100/volume at baseline.|Baseline, Month 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."||Percent change||Standard Deviation|Mean
74182|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
74183|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
74184|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
74185|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||Percentage of Participants|||Number
74186|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|During first 12 weeks of treatment|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||participants|||Number
74230|NCT01066585|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severity of the adverse events were defined and classified as follows:~'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 1 up to Day 15 post-application.|Adverse events were assessed in the Intent-to-treat (Safety) population.||Participants|||Number
74187|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||participants|||Number
74188|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74189|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74190|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74191|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74192|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|Th PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74193|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74231|NCT01066585|Secondary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
74194|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74195|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74196|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74197|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74198|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74199|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74200|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74280|NCT01065766|Primary|Change From Baseline to Treatment in FPG at Week 24|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of FPG.||mg/dL||Standard Deviation|Mean
74201|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 international units per millilitre (IU/mL) were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74202|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The per-protocol (PP) population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74203|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks (Wk) after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74204|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
74205|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
74206|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
74281|NCT01065766|Primary|Change From Baseline to Treatment in HbA1c at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.|Baseline and Week 24|All participants with a pre-treatment and a 24-week post-treatment HbA1c value.||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
74207|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants|||Number
74208|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||number of participants|||Number
74209|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||number of participants|||Number
74210|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74211|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74212|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74213|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74383|NCT01064739|Secondary|Supine Heart Rate|Supine heart rate 6 hours after breakfast|6 hours after breakfast|||beats per minute||Standard Deviation|Mean
74214|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74215|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74216|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74217|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74218|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74219|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74220|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74232|NCT01066585|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success defined as absence of live lice, was assessed in index participants, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
74384|NCT01064739|Secondary|Supine Systolic Blood Pressure|Supine systolic blood pressure 6 hours after breakfast|Supine-6 hours after breakfast on both study days.|||mm Hg||Standard Deviation|Mean
74221|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74222|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74223|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74224|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74225|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.||percentage of participants||95% Confidence Interval|Number
74226|NCT01066780|Secondary|The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.||2-4 weeks||||||
74227|NCT01066780|Primary|Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise|This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.|4 Weeks|||percentage of words scored correctly||Standard Deviation|Mean
74228|NCT01066624|Primary|Incidence of Oral Mucositis|Incidence of grade I-IV oral mucositis|First 30 days post-tranplantation|||percentage of participants|||Number
74229|NCT01066585|Secondary|Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-treat (Safety) population.||Participants|||Number
74233|NCT01066546|Secondary|Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Total possible score is sum of individual items, ranged from 5 to 15; lower score indicated a better health state."|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
74234|NCT01066546|Secondary|Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver’s job. Overall cost of care was evaluated to quantify the resources utilized.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
74235|NCT01066546|Secondary|Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer’s Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
74236|NCT01066546|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
74237|NCT01066546|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
74238|NCT01066546|Secondary|Change From Baseline in Alzheimer’s Disease Cooperative Study–Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
74239|NCT01066546|Secondary|Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis (0-8), visuospatial ability (0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score=greater cognitive impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.|||||
74240|NCT01066546|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 4 weeks after last dose of study treatment|Safety analysis population included all enrolled participants who received at least 1 dose of study treatment, including partial doses.||participants|||Number
74241|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in percentages."|From baseline (day 1) visit to day 7|||Percentage change in scale VAS||Inter-Quartile Range|Median
74242|NCT01066520|Secondary|Global Judgment of Efficacy||Day 14||||||
74243|NCT01066520|Secondary|Time to Normal Function (Training/Sports)||Day 1 to 4, 7, 14, 42||||||
74244|NCT01066520|Secondary|Physician's Assessment of Normal Function/Activity (5-point-scale)||Day 1 to 4, 7, 14, 42||||||
74245|NCT01066520|Secondary|Swelling ('Figure-of-eight')||Day 1 to 4,7,14||||||
74246|NCT01066520|Secondary|FAAM Sports Subscale||Day 1 to 4, 7, 14, 42||||||
74247|NCT01066520|Secondary|FAAM ADL Subscale||Day 1 to 4, 14, 42||||||
74259|NCT01066039|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 6 was calculated as HbA1c at Month 6 minus HbA1c at baseline.|Baseline, Month 6|Full analysis set (FAS) included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||Percent HbA1c||Standard Deviation|Mean
74385|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 8-12 hours after breakfast|8 to 12 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
74248|NCT01066520|Primary|Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7|"The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.~Each item is scored on a 5-point Likert scale (4 to 0) from ‘no difficulty at all’ (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to ‘unable to do’ (score 0). Responses marked as ´not applicable´were not counted.~Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction."|Day 1 to day 7|Changes to Baseline: absolute values. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the ‘Last Observation Carried Forward’ method.||Scores on a scale||Inter-Quartile Range|Median
74249|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in absolute values."|From baseline (day 1) visit to day 7|Changes from baseline at day7: absolute values and in percentage. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method.||Absolute value units on a scale VAS||Inter-Quartile Range|Median
74250|NCT01066039|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 6|Safety population included all participants who received at least one dose of investigational product.||participants|||Number
74251|NCT01066039|Secondary|Change From Baseline in Microalbumin Level at Month 6|The change in microalbumin level at Month 6 was calculated as microalbumin level at Month 6 minus microalbumin level at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||mg/dL||Standard Deviation|Mean
74252|NCT01066039|Secondary|Change From Baseline in Albumin/Creatinine Ratio at Month 6|The change in albumin/creatinine ratio at Month 6 was calculated as albumin/creatinine ratio at Month 6 minus albumin/creatinine ratio at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||ratio||Standard Deviation|Mean
74253|NCT01066039|Secondary|Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6|The change in total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels at Month 6 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at Month 6 minus total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at baseline, respectively.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||milligram per deciliter (mg/dL)||Standard Deviation|Mean
74254|NCT01066039|Secondary|Change From Baseline in C-Peptide Level at Months 3 and 6|The change in C-peptide level at Months 3 and 6 was calculated as C-peptide level at Months 3 and 6 minus C-peptide level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
74255|NCT01066039|Secondary|Change From Baseline in Insulin Level at Months 3 and 6|The change in insulin level at Months 3 and 6 was calculated as insulin level at Months 3 and 6 minus insulin level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.||mcIU/mL||Standard Deviation|Mean
74256|NCT01066039|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6|HOMA-IR is as an indicator of insulin resistance in participants with Type 2 diabetes mellitus and comorbid hypertension. HOMA-IR was derived from fasting plasma glucose (FPG) and fasting insulin (FI) using the formula: (FI [micro international units per milliliter {mcIU/mL}] * FPG [millimole per liter {mmol/L}]) divided by 22.5. The change in HOMA-IR at Months 3 and 6 was calculated as HOMA-IR at Months 3 and 6 minus HOMA-IR at baseline.|Baseline, Months 3 and 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||mcIU/mL * mmol/L||Standard Deviation|Mean
74257|NCT01066039|Secondary|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6|The change in SBP, DBP, and mean BP at Month 6 were calculated as SBP, DBP, and mean BP at Month 6 minus SBP, DBP, and mean BP at baseline, respectively. Mean BP was calculated using the formula: (DBP plus [{SBP minus DBP} divided by 3]).|Baseline, Month 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||mmHg||Standard Deviation|Mean
74258|NCT01066039|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 3 was calculated as HbA1c at Month 3 minus HbA1c at baseline.|Baseline, Month 3|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.||Percent HbA1c||Standard Deviation|Mean
74260|NCT01066000|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8– 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.||Participants|||Number
74261|NCT01066000|Secondary|Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods|Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.|Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20|ITT population was defined as all participants who entered into study and took at least one dose of study drug. The ITT and safety population were identical. Data of maximum number of participants (24 participants) available at the time of analysis were analysed and 9 participants discontinued the study before this analysis.||μg/month||Standard Deviation|Mean
74262|NCT01066000|Secondary|Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods|Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Months||Standard Deviation|Mean
74263|NCT01066000|Secondary|Mean Time Spent by Participants in the Haemoglobin Range of 10 – 12 g/dL During the Efficacy Evaluation Period|Mean time spent in the haemoglobin range 10 – 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Weeks||Standard Deviation|Mean
74264|NCT01066000|Secondary|Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period|The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Percentage of participants|||Number
74265|NCT01066000|Secondary|Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period|The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||g/dL||Standard Deviation|Mean
74266|NCT01066000|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.||Participants|||Number
74267|NCT01066000|Primary|Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)|The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.|Up to Week 24|Intent to treat (ITT) population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.||Percentage of participants|||Number
74268|NCT01065844|Secondary|Quality of Life|Quality of life as measured by the EORTC QLQ-C30 survey|every 1 to 3 months||||||
74269|NCT01065844|Primary|Tumor Progression|Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).|Every 1 to 3 months|Those with adverse events necessitating interruption of intervention and removal from study were not assessed for outcome measures||Participants|||Count of Participants
74279|NCT01065766|Primary|Change From Baseline in 2hr-PPG at Week 24|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of 2hr-PPG.||mg/dL||Standard Deviation|Mean
74386|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 4-8 hours after breakfast|4 to 8 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
74270|NCT01065779|Primary|Change From Baseline in Alkaline Phosphatase at End of Treatment|For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||mg/dL||Standard Deviation|Mean
74271|NCT01065779|Primary|Change From Baseline in Urine Deoxypyridinoline at End of Treatment|For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||nmol/mmol||Standard Deviation|Mean
74272|NCT01065779|Primary|Change From Baseline in Serum Osteocalcin at End of Treatment|For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||ng/mL||Standard Deviation|Mean
74273|NCT01065779|Primary|Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment|For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.||ng/mL||Standard Deviation|Mean
74274|NCT01065779|Primary|Number of Participants With Improved, Unchanged, or Worsened Disease|"Evaluation of disease improvement was conducted in 3 categories of improved, unchanged, or worsened. Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either improved, unchanged, or worsened."|Baseline and end of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation.||Participants|||Number
74275|NCT01065779|Primary|Number of Participants With Non-Serious AEs|An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.||Participants|||Number
74276|NCT01065779|Primary|Number of Participants With Unexpected Adverse Events|Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.||Participants|||Number
74277|NCT01065779|Primary|Number of Participants With Serious Adverse Events|"Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.~SAEs were considered serious if the event resulted in:~death or was life-threatening~prolonged an existing inpatient hospitalization~a persistent or significant disability/ incapacity~a congenital anomaly/ birth defect~a significant medical situation, other important medical event based upon appropriate medical judgment of the investigator"|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.||Participants|||Number
74278|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24|"Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 24|Participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator.||Percentage of participants|||Number
74387|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 0-4 hours after breakfast|0 to 4 hours after breakfast|||micrograms/4 hours||Standard Deviation|Mean
74282|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12|"Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 12|Participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator.||Percentage of participants|||Number
74283|NCT01065766|Primary|Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG.||mg/dL||Standard Deviation|Mean
74284|NCT01065766|Primary|Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of FPG.||mg/dL||Standard Deviation|Mean
74285|NCT01065766|Primary|Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12|HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.|Baseline and Week 12|All participants with a pre-treatment and a 12-week post-treatment HbA1c value.||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
74286|NCT01065766|Primary|Percentage of Participants With Any Adverse Experience|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 26 weeks|All participants who were included in the safety evaluation||Percentage of participants|||Number
74287|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.|Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle|Baseline to 14 days|per protocol||percentage of participants||Standard Deviation|Mean
74288|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body|Five timed readings ( 0, 15, 30, 45 and 60 minutes) were taken using the Corneometer 825 meter on subjects using Eucerin lotion on targeted area on one half of body|Baseline to 14 days|per protocol||Percentage of participants||Standard Deviation|Mean
74289|NCT01065714|Primary|Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle|Day 1 to Day 14|Per protocol||percent change||Full Range|Median
74290|NCT01065714|Primary|Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion|Day 1 to Day 14|per protocol||percent change||Full Range|Median
74291|NCT01065597|Secondary|Change in Brain-derived Neurotrophic Factor (BDNF) Blood Level|Change in plasma level of BDNF in pg/ml pre and post NET treatment course.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 subjects had a seizure during the first treatment and therefore had no seizure-free (nonconvulsive) data, and 2 subjects declined blood draw||pg/ml||Full Range|Median
74292|NCT01065597|Secondary|Change in Score on the Autobiographical Memory Inventory Short Form (AMI-S)|The Autobiographical Memory Inventory Short Form (AMI-S ) assesses effects on retrograde memory for autobiographical information including information related to a family member, recent travel, events of last New Year's eve, events of last birthday, employment information, and events of last non-psychiatric illness and its treatment. Subjects responded to specific questions regarding these topics before and after their course of NET treatment. Subjects were scored based on the percent of responses post-NET treatment that correctly matched their responses prior to NET treatment. The score range is 0 to 100%. The higher the percent, the less impaired is the autobiographical memory.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data||% correct responses||Standard Deviation|Mean
74293|NCT01065597|Secondary|Change in Score on Mini-mental State Exam|Score range is 0 to 30 points. The higher the score, the better the cognition. So a higher score means less cognitive impairment.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data||units on a scale||Standard Deviation|Mean
74294|NCT01065597|Primary|Change in Score on the 17-item Hamilton Depression Rating Scale|Score range is 0 to 54 points. The higher the score, the more depressed symptoms.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data||units on a scale||Standard Deviation|Mean
74295|NCT01065558|Secondary|Decrease in Self-injurious Behavior at End of Study (Two Weeks After Screening) Compared to Screening|Change in the self-injurious subscale of the Behavior Problems Inventory (BPI). the BPI is a well-validate test to evaluate the frequency and severity of a patient's self-injurious behavior. Values range from 0 to 50, and a low score means few/less severe behaviors|Screening visit and end of study (two weeks)|All patients who received any dose of ecopipam were in the analysis population||Change in BPI score||Standard Deviation|Mean
74388|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 8 to 12 hours after breakfast|8 to 12 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
74389|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 4 to 8 hours after breakfast|4 to 8 hours after breakfast|||micrograms/4 hours||Standard Deviation|Mean
74296|NCT01065558|Primary|Number of Participants With Clinically Significant Changes in Standard Laboratory Tests|This study’s primary outcome is the safety of ecopipam in Lesch-Nyhan patients as measured by standard clinical laboratory tests. The patients will also be observed and questioned about other side effects, such as whether they feel more or less tired.Standard clinical laboratory tests for liver, kidney and blood function were conducted. The normal ranges for each of these tests were different and are too numerous to be individually listed here. However, if any individual value were to be either three-times greater or lesser than the upper or the lower limit of the test, then that value was considered to have been changed.|Two weeks|All patients were analyzed||Participants|||Number
74297|NCT01065506|Primary|Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day|Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up|End of treatment (10 weeks post quit day) and 30-week follow-up|Participants who completed the end of treatment assessment||number of participants|||Number
74298|NCT01065454|Secondary|Osteopontin - Change From Baseline to Week 16|Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||µg/mL||Standard Deviation|Mean
74299|NCT01065454|Secondary|Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16|Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||µmol/L||Standard Deviation|Mean
74300|NCT01065454|Secondary|Troponin T - Change From Baseline to Week 16|Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||µg/L||Standard Deviation|Mean
74301|NCT01065454|Secondary|N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-pro BNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||pg/mL||Standard Deviation|Mean
74302|NCT01065454|Secondary|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||ng/mL||Standard Deviation|Mean
74303|NCT01065454|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16|The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The MLHF total score can range from 0 (best) to 105 (worst).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Scores on a scale||Standard Deviation|Mean
74304|NCT01065454|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Scores on a scale||Standard Deviation|Mean
74305|NCT01065454|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Scores on a scale||Standard Deviation|Mean
74306|NCT01065454|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all cause mortality, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function.|At visit 6 (16 weeks)|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis.||Percentage of participants|||Number
74390|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 0 to 4 hours after breakfast|0 to 4 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
74391|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|8-12 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
74307|NCT01065454|Secondary|WHO (World Health Organization) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement, changes to a higher functional class resemble deterioration of PAH.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Percentage of participants|||Number
74308|NCT01065454|Secondary|6-minute Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||m||Standard Deviation|Mean
74309|NCT01065454|Secondary|Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16|E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||E/A ratio||Standard Deviation|Mean
74310|NCT01065454|Secondary|E-wave Deceleration Time - Change From Baseline to Week 16|E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||msec||Standard Deviation|Mean
74311|NCT01065454|Secondary|Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16|Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mL||Standard Deviation|Mean
74312|NCT01065454|Secondary|Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16|Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mL||Standard Deviation|Mean
74313|NCT01065454|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Percentage||Standard Deviation|Mean
74314|NCT01065454|Secondary|Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16|Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
74315|NCT01065454|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mm||Standard Deviation|Mean
74316|NCT01065454|Secondary|Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16|Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
74317|NCT01065454|Secondary|Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16|The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
74392|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|0-4 hours after breakfast|||ug/4hr||Standard Deviation|Mean
74393|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 6 hours after breakfast|Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74318|NCT01065454|Secondary|Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16|The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80*(SAPmean - RAPmean)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5*m^2||Standard Deviation|Mean
74319|NCT01065454|Secondary|Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16|The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80*(SAPmean - RAPmean)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5||Standard Deviation|Mean
74320|NCT01065454|Secondary|Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16|The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80*(PAPmean - PCWP)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5*m^2||Standard Deviation|Mean
74321|NCT01065454|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||dyn*s*cm^-5||Standard Deviation|Mean
74322|NCT01065454|Secondary|Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16|The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||Percentage||Standard Deviation|Mean
74323|NCT01065454|Primary|Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF [safety analysis set]/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.||mmHg||Standard Deviation|Mean
74324|NCT01065428|Secondary|Neuromechanical Efficiency (NME)|NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).|at 30 minutes of the spontaneous breathing trials (SBT)|||cmH2O/uV||Standard Deviation|Mean
74325|NCT01065428|Primary|Neuroventilatory Efficiency (NVE)|NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.|at 30 minutes of the spontaneous breathing trials (SBT)|||ml/uV||Standard Deviation|Mean
74326|NCT01065350|Secondary|Average Change in Stroke Volume Variation (SVV)|SVV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. SVV is a dynamic flow-based parameter and together with cardiac output provides an indication of fluid responsiveness. The average change in SVV (as compared to baseline SVV) during the specified time intervals is reported. SVV is calculated by taking the SVmax – SVmin /*100/ SV mean.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 38/35 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Percentage of mean stroke volume||Standard Deviation|Mean
74327|NCT01065350|Secondary|Average Change in Stroke Volume Index (SVI)|SVI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SVI (as compared to baseline SVI) during the specified time intervals is reported. To determine SVI, stroke volume is divided by the body surface area in order to account for body size.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Milliters per beat per m^2 of body area||Standard Deviation|Mean
74328|NCT01065350|Secondary|Average Change in Stroke Volume (SV)|SV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SV from baseline during the specified time intervals is reported. SV is the milliliters of blood ejected during each contraction of the heart.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Milliliters of blood per beat||Standard Deviation|Mean
74329|NCT01065350|Secondary|Average Change in Total Peripheral Resistance Index (TPRI)|TPRI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPRI from baseline during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/39 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||dynes * sec/cm^-5/m^2||Standard Deviation|Mean
74330|NCT01065350|Secondary|Average Change in Total Peripheral Resistance (TPR)|TPR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPR from baseline during the specified time intervals is reported. TPR is the overall resistance to blood flow through the systemic blood vessels.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/38 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||dynes * sec/cm^-5||Standard Deviation|Mean
74331|NCT01065350|Secondary|Average Change in Mean Arterial Pressure (MAP)|"MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in MAP from baseline during the specified time intervals is reported.~MAP is a term used in medicine to describe an average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 43/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
74332|NCT01065350|Secondary|Average Change in Diastolic Blood Pressure (DBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in DBP (as compared to baseline DBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|||mmHg||Standard Deviation|Mean
74333|NCT01065350|Secondary|Average Change in Systolic Blood Pressure (SBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SBP (as compared to baseline SBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|||mmHg||Standard Deviation|Mean
74334|NCT01065350|Secondary|Average Change in Heart Rate (HR)|HR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in HR (as compared to baseline HR) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|||Beats per minute||Standard Deviation|Mean
74335|NCT01065350|Secondary|Average Change in Cardiac Index (CI)|"CI was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CI as compared to the baseline CI during the specified time intervals is reported.~To determine CI, cardiac output is divided by the body surface area in order to account for body size."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Liters per minute per m^2 of body area||Standard Deviation|Mean
74336|NCT01065350|Secondary|Average Change in Cardiac Output (CO)|"CO was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CO as compared to baseline CO during the specified time intervals is reported.~CO is defined as the quantity of blood ejected per minute by the heart into the systemic circulation. It is the product of the heart rate (HR) (beats per minute) times the stroke volume (SV) (milliliters of blood ejected during each contraction)."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.||Liters per minute||Standard Deviation|Mean
74337|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia|MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in MAP of greater than 20% during the specified time intervals is reported, as compared to the baseline MAP reading.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.||Percentage of subjects|||Number
74338|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in DBP of greater than 20% during the specified time intervals is reported, as compared to the baseline DBP reading. The second or lower number of a blood pressure reading is the DBP and is the measure taken when your heart is at rest.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.||Percentage of subjects|||Number
74339|NCT01065350|Primary|Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.||Percentage of subjects|||Number
74340|NCT01065051|Secondary|Change in the Ventilatory Efficiency (V’E/V’CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)|Ventilatory efficiency (V’E/V’CO2) and anaerobic threshold (AT) were parameters directly measured or derived by computed analysis from the spiroergometry system during the cardiopulmonary exercise test.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74341|NCT01065051|Secondary|Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests|The slope of the relationship between work rate during cardiopulmonary exercise tests and PAPmean is derived from the directly measured hemodynamic parameter mean pulmonary arterial pressure (PAPmean). PAPmean is acquired during a right heart catheterization.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74342|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E’) During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak early diastolic velocity (E’) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74343|NCT01065051|Secondary|Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74344|NCT01065051|Secondary|Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests|The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74345|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74346|NCT01065051|Secondary|Change in Peak Power Index During the Cardiopulmonary Exercise Tests|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. Formula: Peak Power Index = (SAPmean - PCWPmean)*CO*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74347|NCT01065051|Secondary|Change in End-systolic Elastance at Rest|The end-systolic elastance is a calculated hemodynamic parameter. It is approximated by the directly measured hemodynamic parameter end-systolic pressure divided by the directly measured echocardiography parameter left ventricular end-systolic volume (LVESV). The end-systolic pressure is acquired during a right heart catheterization. The LVESV is acquired during a non-invasive echocardiography examination. Approximated by end-systolic pressure/LVESV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74348|NCT01065051|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) at Rest|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74349|NCT01065051|Secondary|Change in Left Ventricular Stroke Work Index (LVSWI) at Rest|The left ventricular stroke work index (LVSWI) is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The LVSWI is also dependent of the calculated hemodynamic parameter stroke volume index (SVI). Formula: LVSWI = (SAPmean – PCWPmean)*SVI*0.0136|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74350|NCT01065051|Primary|Change in Peak Power Index at Rest|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)*CO [cardiac output]*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.|||||
74351|NCT01064947|Secondary|Local Tolerability|"The investigator assessed the following characteristics on a grading scale of 0-3 (none, mild moderate or severe): erythema, inflammation, infection, crusting, necrosis, peeling, swelling and contact dermatitis.~The subject assessed the following characteristics on a scale of 0-3 (none, mild, moderate or severe): irritation, itchiness burning, tenderness and pain."|Day 7|||units on a scale||Inter-Quartile Range|Median
74352|NCT01064947|Secondary|Investigator Assessment of Clinical Cure|The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default|Day 7|||participants|||Number
74353|NCT01064947|Secondary|Skin Infection Rating Scale (SIRS)|The Primary Investigator rated the each of the following characteristics: exudate/pus, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain on a scale of 0-6 (absent-severe) to create an overall SIRS score ranging from 0-42.|Day 1 and Day 7|||units on a scale||Inter-Quartile Range|Median
74354|NCT01064947|Primary|Bacteriological Culture|All participants were cultured for S.aureus (MRSA), S.aureus (MSSA) and S. pyogenes at Baseline. If positive at Baseline then they were cultured again at Day 7.|Day 1 and Day 7|||participants|||Number
74355|NCT01064882|Secondary|Treatment Satisfaction Questionnaire Score at Month 3|The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).|Month 3|Modified Intent-to-Treat: All randomized subjects who were treated with the intended study medication and completed at least one follow-up visit.(Note: 2 subjects in the Bim 0.015% treatment group, 1 subject in the Bim 0.005% treatment group, and 1 subject in the Bim 0.03% treatment group did not have Month 3 visit data for this outcome measure)||Scores on a Scale||Standard Deviation|Mean
74356|NCT01064882|Secondary|Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3|Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.||Scores on a Scale||Standard Deviation|Mean
74357|NCT01064882|Secondary|Change From Baseline in Overall Eyelash Satisfaction at Month 3|"Change from baseline at Month 3 in question 3 overall, how satisfied are you with your eyelashes? Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline."|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.||Scores on a Scale||Standard Deviation|Mean
74358|NCT01064882|Secondary|Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3|Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.|Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.||Percentage of Subjects|||Number
74359|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3|Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)||Units on a Scale||Standard Deviation|Mean
74360|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Thickness at Month 3|Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)||Millimeters squared (mm^2)||Standard Deviation|Mean
74361|NCT01064882|Primary|Change From Baseline in Eyelash Length at Month 3|Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one-follow-up visit. (Note that one subject in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)||millimeters (mm)||Standard Deviation|Mean
74362|NCT01064856|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12|The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and with non-missing values for both Baseline and post-baseline visit.||units on a scale||Standard Deviation|Mean
74394|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 4 hours after breakfast|4 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74395|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 2 hours after breakfast|2 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74396|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 1 hour after breakfast|1 hour after breakfast|||pg/mL||Standard Deviation|Mean
74397|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 6 hours after breakfast|6 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74363|NCT01064856|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74364|NCT01064856|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74365|NCT01064856|Secondary|Change From Baseline in Dactylitis at Week 12|Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values for both Baseline and the post-baseline.||units on a scale||Standard Deviation|Mean
74366|NCT01064856|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12|Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74367|NCT01064856|Secondary|Change From Baseline in Leeds Enthesitis Index at Week 12|Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74368|NCT01064856|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74369|NCT01064856|Secondary|Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12|The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values.||units on a scale||Standard Deviation|Mean
74398|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 4 hours after breakfast|4 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74399|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 2 hours after breakfast|2 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74400|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 1 hour after breakfast|1 hour after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74649|NCT01061671|Secondary|Change in FEV1 (% Pred) From Baseline to Last Measure||Baseline, last measure at up to 37 months|Analysis excludes participants without any follow-up data.||percent predicted||90% Confidence Interval|Median
74370|NCT01064856|Secondary|Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12|The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74371|NCT01064856|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74372|NCT01064856|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12|A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
74373|NCT01064856|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|Baseline (day of first study drug administration) through Week 156 plus 70 days|Safety Analyses included all participants who received at least 1 dose of double-blind study drug.||participants|||Number
74374|NCT01064856|Primary|Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12|Percentage of participants achieving the following composite response at Week 12: >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA – Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and >= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.|Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).||percentage of participants|||Number
74375|NCT01064830|Secondary|Patients Assessment of Satisfaction With Length of Fingernails|"the percentages of participants who were satisfied with the length of fingernails"|20 weeks|all patients enrolled who completed this response measure at week 20.||percentage of patients|||Number
74376|NCT01064830|Primary|• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.|IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails|20 weeks|||patients|||Number
74377|NCT01064817|Primary|Subjects With Safety Related Events or Findings|The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields|First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs|||participants|||Number
74378|NCT01064817|Other Pre-specified|Bleb Scarring|Exploratory Efficacy Outcome measure: Bleb scarring is graded on a scale from 0-3. 0= none to minimal scarring, 1= mild, 2= moderate, 3= severe scarring.|Day 120|Number of subjects who had assessment of bleb scarring on Day 120||units on a scale||Standard Deviation|Mean
74379|NCT01064817|Other Pre-specified|Successful Intra-ocular Pressure (IOP) Control|Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP|Day 120|||participants|||Number
74380|NCT01064817|Primary|Safety of Subconjunctival Injection|Number of adverse events (AEs), treatment emergent adverse events (TEAEs), non-ocular TEAEs, Ocular TEAEs, serious adverse events (SAEs), abnormal slit-lamp biomicroscopic findings, and abnormal dilated fundoscopy findings|AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30|All subjects enrolled in study; all subjects received all study treatment||Number of occurrences|||Number
74381|NCT01064739|Secondary|Urinary Sodium|urinary sodium 8-12 hours after breakfast|8-12 hours after breakfast|||mEq/4hr||Standard Deviation|Mean
74382|NCT01064739|Secondary|Urinary Sodium|Urinary sodium excreted 0-4 hours after breakfast.|0-4 hours after breakfast|||mEq/4hr||Standard Deviation|Mean
74401|NCT01064739|Secondary|Plasma Dopa 6 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 6 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74402|NCT01064739|Primary|Urinary Sodium|Urinary sodium excreted 4-8 hours after breakfast was designated as a primary outcome. Other urine samples (0-4 hr, 8-12 hr after breakfast) are considered as non-primary outcomes.|4 to 8 hours after breakfast|||mEq/4 hr||Standard Deviation|Mean
74403|NCT01064739|Primary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|4-8 hours after breakfast|||micrograms/4hr||Standard Deviation|Mean
74404|NCT01064739|Secondary|Plasma Dopa 4 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 4 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74405|NCT01064739|Secondary|Plasma Dopa 2 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 2 hours after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74406|NCT01064739|Primary|Plasma Dopa 1 hr After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 1 hour after breakfast on both study days.|||pg/mL||Standard Deviation|Mean
74407|NCT01064687|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who were randomized at baseline to LY2189265 and received at least 1 dose of study drug with evaluable AUC data.||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
74408|NCT01064687|Secondary|Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable NT-proBNP data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
74409|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.||||Standard Error|Least Squares Mean
74410|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||||Standard Error|Least Squares Mean
74411|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.||participants|||Number
74412|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||participants|||Number
74451|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
74413|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.||participants|||Number
74414|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 26 Weeks|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.||participants|||Number
74415|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.||participants|||Number
74416|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||participants|||Number
74417|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
74418|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo. Only pre-rescue measurements were used.||events per participant per year||Standard Deviation|Mean
74419|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.||events|||Number
74474|NCT01064310|Secondary|Number of Participants With the Indicated Number of Dose Reductions|Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.||participants|||Number
74420|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||events|||Number
74421|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Serum Calcitonin||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
74422|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Serum Calcitonin||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
74423|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter||Inter-Quartile Range|Median
74424|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units per liter||Inter-Quartile Range|Median
74425|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.||participants|||Number
74426|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.||participants|||Number
74427|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Mean
74428|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable blood pressure data.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
74429|NCT01064687|Secondary|Change in Baseline to 52 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
74430|NCT01064687|Secondary|Change in Baseline to 26 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable seated pulse rate data.||beats per minute (bpm)||Standard Error|Least Squares Mean
74452|NCT01064687|Secondary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
74431|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable ECG QTcF Interval or PR Interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
74432|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable ECG QTcF Interval or PR interval data.||milliseconds (msec)||Standard Error|Least Squares Mean
74433|NCT01064687|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event since the previous inquiry. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. The number of participants with adjudicated CV events was not collected at 26 weeks.||participants|||Number
74434|NCT01064687|Secondary|Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable IW-SP data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74435|NCT01064687|Secondary|Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74436|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable APPADL data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74453|NCT01064687|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
74650|NCT01061671|Secondary|Time to First COPD Exacerbation||up to 37 months|Analysis excludes participants without any follow-up data.||Days to the first exacerbation||95% Confidence Interval|Median
74437|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74438|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions|The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively. Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable DTSQs or DTSQc data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74439|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). The DTSQ change version (DTSQc) was not collected at 26 weeks. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74440|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable EQ-5D data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74441|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Error|Least Squares Mean
74454|NCT01064622|Secondary|Activity (Overall Response Rate) in Crossover Patients|RECIST response rate in patients after crossover from placebo to vismodegib arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analyses.||percentage of participants||95% Confidence Interval|Number
74651|NCT01061671|Primary|Rates of COPD Exacerbations||up to 37 months|Analysis excludes participants without any follow-up data.||exacerbations/person-year||Standard Deviation|Mean
74442|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
74443|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.||percentage of HOMA2||Standard Error|Least Squares Mean
74444|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
74445|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
74446|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable SMPG data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
74447|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable SMPG data. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
74448|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable BMI data. Only pre-rescue measurements were used.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
74449|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable BMI data. Only pre-rescue measurements were used.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
74450|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable body weight data. Only pre-rescue measurements were used.||kilograms (kg)||Standard Error|Least Squares Mean
74456|NCT01064622|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analysis.||percentage of participants||95% Confidence Interval|Number
74457|NCT01064622|Secondary|Overall Survival|Time from randomization to death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.||months||95% Confidence Interval|Median
74458|NCT01064622|Primary|Progression-free Survival|Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.||months||95% Confidence Interval|Median
74459|NCT01064414|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||mg/dL||Standard Error|Least Squares Mean
74460|NCT01064414|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
74461|NCT01064414|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
74462|NCT01064401|Secondary|Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks|The MSIS-29 is a 29-item disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of ≥ 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.|Baseline and 96 weeks|participants with a baseline and Week 96 assessment||percentage of participants|||Number
74463|NCT01064401|Secondary|Proportion of Participants Relapse-free at Week 144|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.|144 weeks|||proportion of participants|||Number
74464|NCT01064401|Secondary|Proportion of Participants With Sustained Disability Progression at 144 Weeks|Sustained disability progression is defined as: at least a 1.0-point increase on the EDSS from Baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.|Baseline through 144 weeks|||proportion of participants|||Number
74465|NCT01064401|Secondary|Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96|The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.|up to 96 weeks|participants with baseline and at least one post-baseline MRI measurement||lesions||95% Confidence Interval|Mean
74475|NCT01064310|Secondary|Time to Dose Modification|For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.||weeks||95% Confidence Interval|Median
74466|NCT01064401|Primary|Adjusted Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.|Up to 144 weeks|participants with a relapse||relapses per person-years|Participants|95% Confidence Interval|Number
74467|NCT01064362|Secondary|Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.||participants|||Number
74468|NCT01064362|Primary|Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.||participants|||Number
74469|NCT01064310|Secondary|Change From Baseline (BL) in Heart Rate|Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.||Beats per minute||Standard Deviation|Mean
74470|NCT01064310|Secondary|Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)|When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
74471|NCT01064310|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants with adverse events leading to permanent discontinuation of study treatment were evaluated.||participants|||Number
74472|NCT01064310|Secondary|Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population||participants|||Number
74473|NCT01064310|Secondary|Number of Participants With the Indicated Reason for Receiving a Dose Reduction|Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|"Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated. Participants may be counted multiple times for the same reason for a dose reduction if the participant had multiple reductions for the same reason."||participants|||Number
74652|NCT01061606|Secondary|Time to Progression||Time to progression is defined as the time from registration to disease progression.|The study concluded terminated early and patients were not followed.|||||
74476|NCT01064310|Secondary|Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores|The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])|Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.||Scores on a scale||Standard Deviation|Mean
74477|NCT01064310|Secondary|Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score|Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.|Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])|Safety-Randomized Study Population: participants who received at least one dose of either drug regardless of treatment period. Participants who received mixed treatment within a period were excluded. Only those participants contributing data at the indicated time points were evaluated.||Scores on a scale||Standard Deviation|Mean
74478|NCT01064310|Primary|"Number of Participants Answering Yes, no, or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire"|The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|mITT Population. Responses to some categories of the PPQ may be missing for some participants.||participants|||Number
74479|NCT01064310|Primary|Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)|The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.||participants|||Number
74480|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.||infants|||Number
74481|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.||infants|||Number
74482|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received|The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.||infants|||Number
83762|NCT00967668|Primary|Change in Weight|Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data|12 months after enrollment|||Kilograms||95% Confidence Interval|Mean
74483|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.||infants|||Number
74484|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.||infants|||Number
74485|NCT01064297|Primary|Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.||infants|||Number
74486|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of live births, fetal deaths with pregnancy loss occurring >=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to the lamotrigine polytherapy without valproate||infants|||Number
74487|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate.||infants|||Number
74488|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy.||infants|||Number
74489|NCT01064167|Secondary|Postoperative Chest Tube Drainage||24h postoperative|||ml||Standard Deviation|Mean
74490|NCT01064167|Primary|Number of Patients Required Allogenic Red Blood Cells Transfusion||1month postoperative|As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery.||participants|||Number
74491|NCT01063907|Secondary|Phase 1: PK Elimination t½ hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.||hr||Standard Deviation|Mean
74492|NCT01063907|Secondary|Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.||hr*ng/mL||Standard Deviation|Mean
74493|NCT01063907|Secondary|Phase 1: PK Exposure Cmax ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.||ng/mL||Standard Deviation|Mean
74494|NCT01063907|Secondary|Phase 1: PK Absorption Tmax hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.||hr||Standard Deviation|Mean
74495|NCT01063907|Primary|To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).|"The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.~The ORR, was defined as the best response over a specified number of cycles (calculated and summarized).~Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized)."|21 day cycle, up to 52 weeks|All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.||participants|||Number
74496|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT])"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of < 1 minute and patients with an IELT of > 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74497|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Disease Type)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74498|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Dosage)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which “subgroup by dosage” was categorized based on dose-titration patterns observed during the course of the treatment period."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74499|NCT01063881|Secondary|Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74500|NCT01063881|Secondary|The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to the speed of ejaculation. Patient's were asked: Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely? The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74501|NCT01063881|Secondary|The Patient's Level of Personal Distress Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation. Patient's were asked: Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely. The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74502|NCT01063881|Secondary|The Patient's Level of Satisfaction With Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale. Patients were asked: Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
92761|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])||Baseline up to Month 7|||percentage of participants|||Number
74503|NCT01063881|Secondary|The Patient's Level of Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74504|NCT01063881|Primary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment"|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients who described improvement with their PE of at least slightly better after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.||Patients|||Number
74505|NCT01063868|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|Entire Study|Safety analysis set (All randomized participants who took at least one dose of study medication).||participants|||Number
74506|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Slightly Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better”. The percentage of patients who reported improvement in PE of at least slightly better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
74507|NCT01063855|Secondary|The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 1-category decrease (improvement) in interpersonal difficulty related to ejaculation is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
74508|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better”. The percentage of patients who reported improvement in PE of at least better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
74509|NCT01063855|Secondary|The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater increase in satisfaction with sexual intercourse is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
74510|NCT01063855|Secondary|The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation and control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported a composite score of at least a 2-category increase in control over ejaculation and at least a 1-category decrease (improvement) in personal distress is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
74511|NCT01063855|Secondary|The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater decrease (improvement) in personal distress related to the speed of ejaculation is provided in the table below."|At Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
74530|NCT01063517|Secondary|Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74512|NCT01063855|Secondary|The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 2-category increase in control over ejaculation is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||Percentage of Patients|||Number
74513|NCT01063855|Primary|The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12|The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.|Baseline, Week 12|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.||minutes||Standard Deviation|Mean
74514|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)|"The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented.~Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as:~(B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7."|From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)|Full Analysis Set (FAS).||Percent reduction||Inter-Quartile Range|Median
74515|NCT01063764|Secondary|Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).||participants|||Number
74516|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 10-weeks Evaluation Period|"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.||participants|||Number
74517|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 14-weeks Treatment Period|"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).||participants|||Number
74518|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.||percentage of participants||95% Confidence Interval|Number
74519|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).||percentage of participants||95% Confidence Interval|Number
74520|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period|"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.||Seizures per week||Inter-Quartile Range|Median
74521|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.||Seizures per week||Inter-Quartile Range|Median
74544|NCT01063517|Secondary|Overall Survival (OS) in the Overall Study Population|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including all randomised patients||months||Inter-Quartile Range|Median
74522|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period|"The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:~(B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data at Baseline and during the Evaluation Period.||Percent reduction||95% Confidence Interval|Median
74523|NCT01063764|Primary|Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).||percentage of participants|||Number
74524|NCT01063764|Primary|Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:~(B values- T values) / B values x 100.~Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22|Full Analysis Set (FAS).||Percent reduction||95% Confidence Interval|Median
74525|NCT01063712|Secondary|Number of Patients With a Decreased Dilation of the Left Heart Chamber (Time Frame: One Year After Treatment). Dilation of the Left Ventricle and Left Atrium Was Measured Before and One Year After Implantation by Echocardiography.|The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.|one year after percutaneous closure|"The patient selection was based in the consecutive case and intention to treat method. All patients recruited in the determinated time frame (June 2009 to May 2010) who met the initial inclusion criteria were treated in the catheterisation laboratory. There the definite inclusion criteria were applied."||participants|||Number
74526|NCT01063712|Primary|Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)|The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.|up to one year after percutaneous closure|"29 patients were controled in a period of one year and were examinated by echocardiography.The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."||Participants|||Number
74527|NCT01063595|Secondary|Concentration of Plasmin Inhibitor|Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.|From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.||Percentage inhibition||Standard Deviation|Mean
74528|NCT01063595|Primary|Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C|Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.||Percentage change||Standard Deviation|Mean
74529|NCT01063595|Primary|Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI|Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.||Percentage change||Standard Deviation|Mean
74567|NCT01063062|Secondary|C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP), a test for inflammation, at Weeks 4, 8, 12, 16, 20 and 24 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had data for at least one follow-up variable, with data available for the given timepoint.||mg/L||Standard Deviation|Mean
74531|NCT01063517|Secondary|Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74532|NCT01063517|Secondary|Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74533|NCT01063517|Secondary|Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74534|NCT01063517|Secondary|Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74535|NCT01063517|Secondary|Time to Deterioration in QoL Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having pain domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74536|NCT01063517|Secondary|Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74537|NCT01063517|Secondary|Time to Deterioration in QoL Fatigue Score in the Overall Study Population|Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having fatigue score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74538|NCT01063517|Secondary|Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population|Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having global score calculated at baseline and at least one post baseline visit||months||Inter-Quartile Range|Median
74539|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.||Percent change||Standard Deviation|Mean
74540|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the Overall Study Population|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population - randomised patients having measurable disease at baseline.||Percent change||Standard Deviation|Mean
74541|NCT01063517|Secondary|Objective Response Rate (ORR) in the ATM Negative Patients|Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.||Participants|||Number
74542|NCT01063517|Secondary|Objective Response Rate (ORR) in the Overall Study Population|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population - randomised patients having measurable disease at baseline.||Participants|||Number
74543|NCT01063517|Secondary|Overall Survival (OS) in ATM Negative Patients|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients||months||Inter-Quartile Range|Median
74545|NCT01063517|Primary|Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients||months||Inter-Quartile Range|Median
74546|NCT01063517|Primary|Progression Free Survival (PFS) in the Overall Study Population|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including all randomised patients||months||Inter-Quartile Range|Median
74547|NCT01063348|Secondary|Skin Picking Self Assessment Scale (SP-SAS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score."|Once every three weeks for the duration of the 12 week study for each subject|||units on a scale||Standard Deviation|Mean
74548|NCT01063348|Primary|Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported."|Once every three weeks during the 12 week study for each subject|||units on a scale||Standard Deviation|Mean
74549|NCT01063153|Primary|Brain Activity Flow Patterns Analysis (BAFPA)|Brain Activity Flow Patterns are electrical networks in the brain that activate in response to a given stimulus (i.e. a computer task)|Single Point (Baseline)||07/2016||||
74550|NCT01063153|Primary|Adult ADHD Investigator Symptom Rating Scale (AISRS)|An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta.|Baseline and 6 weeks|Subjects in the ADHD group who completed all 6 weeks of the trial were included in data analysis. Subjects who completed at least 3 weeks of treatment were also included regardless of the reason for withdrawal, and final-visit AISRS scores were used in ITT (intent-to-treat) analysis via last observation carried forward [LOCF] imputation.||units on a scale||Standard Deviation|Mean
74551|NCT01063075|Primary|Cetuximab PK: Confirmatory Serum Concentration||Group D: Prior to Carboplatin Infusion, Cycle 1, Day 1|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data. Study design by intent did not collect data from Groups A, B, and C.||micrograms per milliliters (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
74552|NCT01063075|Primary|Cetuximab PK: Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.||Hour (h)||Full Range|Median
74553|NCT01063075|Primary|Total Carboplatin PK: Time of Maximum Observed Plasma Concentration (Tmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.||Hour (h)||Full Range|Median
74554|NCT01063075|Primary|Cetuximab PK: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
74555|NCT01063075|Primary|Total Carboplatin PK: Maximum Observed Plasma Concentration (Cmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
74556|NCT01063075|Primary|Cetuximab PK: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
74653|NCT01061606|Secondary|Time to Treatment Failure|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|From study registration to the date patients end treatment, assessed up to 3 years|The study concluded terminated early and patients were not followed.|||||
74557|NCT01063075|Primary|Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
74558|NCT01063062|Secondary|Number of Participants With Elevated Triglyceride According to ATPIII Guidelines|Blood samples were collected for Triglyceride and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Triglyceride level in milligram/deciliter (mg/dL) was categorized as: Normal (< 150), Borderline High (150- 199), High (200- 499) or Very High (≥ 500). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
74559|NCT01063062|Secondary|Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for Low Density Lipoprotein (LDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the LDL Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Optimal (< 100), Near Optimal/Above Optimal (100- 129), Borderline High (130- 159), High (160-189) or Very High (≥ 190). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
74560|NCT01063062|Secondary|Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for High Density Lipoprotein (HDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the HDL Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Low (< 40) or High (≥ 60). The number of participants with category High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
74561|NCT01063062|Secondary|Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines|Blood samples were collected for Total Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Desirable ( < 200), Borderline High (200- 239) or High (≥ 240). The number of participants categorized Borderline High or High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
74562|NCT01063062|Secondary|Number of Participants With Elevated AST (SGOT) and ALT (SGPT)|Blood was collected for aspartate aminotransferase (serum glutamic oxaloacetic transaminase) [AST/SGOT] and alanine aminotransferase (serum glutamic pyruvic transaminase) [ALT/SGPT], liver function tests, and were analyzed at a central laboratory. The number of participants with High AST (SGOT) or ALT (SGPT) levels at Week 24 is reported.|Week 24|Participants from the safety population, all participants who received study drug and had at least 1 post-dose safety assessment, with data available for analysis.||participants|||Number
74563|NCT01063062|Secondary|Number of Participants With Serious Infections|A serious infection was an infection that qualified as a Serious Adverse Event (SAE). A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
74564|NCT01063062|Secondary|Number of Participants With AE and SAE Related Discontinuation|The number of participants who stopped using the study drug because of an AE or a SAE. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
74565|NCT01063062|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.||participants|||Number
74566|NCT01063062|Secondary|Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR), a test to assess inflammation, at Weeks 4, 8, 12, 16, 20, 24 and was analyzed at a central laboratory. ESR was measured in millimeters/hour (mm/hr).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time point. Last observation carried forward.||mm/hr||Standard Deviation|Mean
74673|NCT01061333|Secondary|Allergen-induced Changes in Urinary Leukotriene (LT) E4|Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed||Fold change over baseline||Standard Deviation|Geometric Mean
74568|NCT01063062|Secondary|Disease Activity Score 28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time-point. Last observation carried forward.||score on a scale||Standard Deviation|Mean
74569|NCT01063062|Secondary|Time to DAS28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||days||95% Confidence Interval|Mean
74570|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Remission|DAS28 Remission was defined as a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||percentage of participants|||Number
74571|NCT01063062|Secondary|Time to DAS28 Clinically Significant Improvement|Time to DAS28 Clinically Significant Improvement was the Time in days from the first infusion of study drug to the achievement of a DAS28 score reduction of at least 1.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||days||95% Confidence Interval|Mean
74572|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Clinically Significant Improvement|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Baseline, Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.||percentage of participants|||Number
74573|NCT01063062|Primary|Time to DAS28 Low Disease Activity|Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received at least one dose of study drug and had data for at least one follow-up variable available. Last observation carried forward.||days||95% Confidence Interval|Mean
74574|NCT01063062|Primary|Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)|Intent-to-treat (ITT) population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward was applied for missing data.||percentage of participants|||Number
74575|NCT01063049|Secondary|The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature|Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).|After Colonoscopy|||units on a scale||Standard Deviation|Mean
74576|NCT01063049|Primary|The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale|The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).|After Colonoscopy|||units on a scale||Standard Deviation|Mean
74577|NCT01063036|Secondary|Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population|Selected criteria presented in each category. Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<). Creatinine data presented below were confirmed, ie, at least 2 consecutive values. On-treatment = after Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|N=treated participants with on-treatment laboratory test results.||participants|||Number
74599|NCT01062841|Primary|Total Number of MDRO (Multidrug Resistant Organisms) Isolated|Total Number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents with indwelling devices over the duration of the study period|From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Residents enrolled with >1 follow-up visit||Total Number of MDRO isolates|||Number
74578|NCT01063036|Secondary|Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population|Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough. Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant’s sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant’s sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S). Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy.|Baseline to Weeks 48, 96|All treated participants who met resistance testing criteria (primary non-response or virologic breakthrough) and were tested for resistance to both study drugs were analyzed. n = number of participants analyzed at Weeks 48 and 96.||participants|||Number
74579|NCT01063036|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. On-treatment = on Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|All Treated participants were analyzed.||participants|||Number
74580|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline|HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline. Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline. Positive result for HBsAg was one of the inclusion criteria. Treated participants (HBsAg positive at baseline) were evaluated using NC=F. The method used was an Immunoassay testing – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized]. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
74581|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline|Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline. The method used: Immunoassay – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized). Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg). Treated participants (HBsAg-positive at baseline) were evaluated using NC=F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48, and 96 (NC = F). An exact binomial 95% Confidence Interval was constructed.||percentage of participants||95% Confidence Interval|Number
74582|NCT01063036|Secondary|Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline|HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
74583|NCT01063036|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline|Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit – procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline to Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
74584|NCT01063036|Secondary|Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population|HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96. Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F).|Weeks 24, 48, 96|All treated participants were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
74600|NCT01062763|Primary|Change of Diastolic Blood Pressure|Change of diastolic blood pressure from baseline to study end at four months.|4 months|Analyzed by intention to treat and last observation carried forward||mm Hg||95% Confidence Interval|Mean
74585|NCT01063036|Secondary|Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population|HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. Baseline was Day 1, prior to study drug administration.|Baseline to Weeks 12, 24, 48, 96|All treated participants with results at both baseline and on-treatment were analyzed. n=Number of treated participants with results at baseline and Week 12, Week 24, Week 48 and Week 96.||log10 IU/mL||Standard Deviation|Mean
74586|NCT01063036|Secondary|Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 24, Week 96|All treated participants were analyzed at Weeks 24 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
74587|NCT01063036|Primary|Percentage of Participants With a Virologic Response at Week 48 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 48|All treated participants were analyzed (NC = F). An exact binomial 95% confidence interval was constructed.||percentage of participants||95% Confidence Interval|Number
74588|NCT01062841|Secondary|Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline)||Number of Residents with New R-GNB|Participants||Number
74589|NCT01062841|Secondary|Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with > 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline)||Number of Residents with New VRE|Participants||Number
74590|NCT01062841|Secondary|Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline)||Number of Residents with New MRSA|Participants||Number
74591|NCT01062841|Secondary|Number of Incident Feeding-tube Associated Pneumonias||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with indwelling feeding tube present (PEG tube), and had >1 follow-up visit||Number of feeding-tube associated pneu|Participants||Number
74592|NCT01062841|Secondary|Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with an indwelling feeding tube present (PEG tube), and had >1 follow-up visit||Numer of feeding-tube SSTIs|Participants||Number
74593|NCT01062841|Secondary|Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only an indwelling urinary catheter present and >1 follow-up visit||Number of CAUTI|Participants||Number
74594|NCT01062841|Primary|Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of Ciprofloxacin-RGNB|||Number
74595|NCT01062841|Primary|Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of Ceftazidime-RGNB isolate|||Number
74596|NCT01062841|Primary|Total Number of VRE (Vancomycin Resistant Enterococci) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of VRE isolates|||Number
74597|NCT01062841|Primary|Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit||Total Number of MRSA isolates|||Number
74598|NCT01062841|Secondary|Number of First Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only a urinary catheter present and >1 follow-up visit||Number of First CAUTI|Participants||Number
74601|NCT01062763|Secondary|Adverse Effects||4 months|Intention to treat||participants|||Number
74604|NCT01062425|Secondary|Progression-free Survival (PFS)|Progression-free survival time is defined as time from randomization to date of first progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without progression are censored at the date of last contact. Progression is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|From randomization to time of first progression or death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.||Months||95% Confidence Interval|Median
74605|NCT01062425|Secondary|Overall Survival (OS)|OS will be estimated using the Kaplan-Meier method and differences between treatment arms will be tested using the log rank test. Multivariate analyses with the Cox proportional hazard model for OS will be performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors.|From randomization to time of death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.||Months||95% Confidence Interval|Median
74606|NCT01062425|Primary|6-month Progression-free Survival Rate|Six-month progression-free survival is the rate of patients who have NOT progressed at six months, where progressive disease is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. Progression will be determined by central review of MRI exams, assessed using MacDonald criteria for progression versus response on 2D T1 and T2 weighted images.|From randomization to 6 months.|Randomized eligible patients with evaluable data at six months. (From the randomized eligible patients, 2 patients withdrew prior to 6 months and 1 did not have an evaluable scan on the placebo arm, while 4 withdrew before 6 months, 3 did not have an evaluable scan, and 2 did not receive protocol treatment on the cediranib arm.)||percentage of participants||95% Confidence Interval|Number
74607|NCT01062308|Secondary|Passive Range of Motion (ROM)|Passive range of motion (ROM) of shoulder was measured with full circle goniometer. The normal range of movement of flexion and abduction is 180 degree.|14 days and 30 days|On the basis of follow up completion||degree||95% Confidence Interval|Mean
74608|NCT01062308|Primary|Pain: Visual Analog Scale|Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 (“No Pain”) to 100 (“Worst Pain Imaginable”) Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability|14 days and 30 days|On the basis of complete follow up||mm||95% Confidence Interval|Mean
74609|NCT01062269|Secondary|Weighted vs. Unweighted BASA Scale|The total aggregate scores for the complete BASA scale were calculated for Cholestyramine 4g, Cholestyramine 12g, and Tang. The total best possible score was 20 and the total worst possible score was 4. A weighted aggregate BASA scale score was also calculated for the Cholestyramine 4g, Cholestyramine 12g, and Tang. The best possible weighted score was 60 and the worst possible weighted score was 4.|1 Day|||Units on Scale||Standard Deviation|Median
74610|NCT01062269|Primary|Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale.|The Bile Acid Sequestrant Acceptability Scale has 4 scoring categories: taste, texture, appearance and mixability. Participants rank each category separately. The best possible score for each category is 5 and the worst possible score is 1.|1 Day|Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.||Units on Scale||Standard Deviation|Mean
74611|NCT01062256|Other Pre-specified|Number of Participant With Cough Severity|Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate.|Baseline|ITT||Participants|||Number
74612|NCT01062256|Secondary|Number of Participants With Global Evaluation of Study Medication|"Participant-rated evaluation of study product; Participants responded to the following question:~How would you rate this product as a cough reliever?” 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent"|4 hours postdose or early termination|ITT||participants|||Number
74613|NCT01062256|Secondary|Change From Baseline in Cough Severity Scale|Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement.|1, 2, 3, and 4 hours postdose|ITT||units on a scale||Standard Deviation|Mean
74614|NCT01062256|Secondary|Number of Cough Bouts Within Each 15-minute Time Interval Postdose|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals.|every 15 minutes postdose up to 240 minutes postdose|ITT||cough bouts||Standard Deviation|Mean
74615|NCT01062256|Secondary|Number of Cough Bouts Over 2-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 2 hours postdose|ITT||cough bouts||Standard Deviation|Mean
74616|NCT01062256|Primary|Number of Cough Bouts Over 4-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 4 hours postdose|Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product.||Cough bouts||Standard Deviation|Mean
74617|NCT01062230|Primary|Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1|All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.|Baseline and Day 1|||% change|||Number
74618|NCT01062165|Primary|Total Clearance of Caspofungin||0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)|||L/hr||Standard Deviation|Mean
74619|NCT01062113|Secondary|Differences in Pain Intensity (PI) Measured by VAS Among Participants|The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.|Pre-additional dose (baseline) and 2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).||mm||Standard Deviation|Mean
74620|NCT01062113|Secondary|Pain Intensity Measured by Visual Analog Scale (VAS)|The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.|2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).||mm||Standard Deviation|Mean
74621|NCT01062113|Secondary|Number of Participants in Each Pain Intensity (PI) With 4 Categories|"Pain intensity was entered in the patient diary on the following categories: No pain, Mild pain, Moderate pain and Severe pain."|2 hours after additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).||participants|||Number
74622|NCT01062113|Primary|Efficacy Rate (Percentage) of Patient’s Impression|"Patient’s impression was assessed by self-report and was entered in the patient diary, based on the following categories: Excellent,  Good, Fair and Poor.~Efficacy rate was calculated from the following formula, The number of participants assessed as Excellent or Good over total participants multiplied by 100."|2 hours post-additional dose|The full analysis set (FAS). This analysis set consisted of randomized participants who received the additional dose of the study drug and who were assessed for at least one efficacy endpoint after randomization.||percentage of participants|||Number
74623|NCT01062074|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol||Percent of participants|||Number
74624|NCT01062074|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol||Percent of participants|||Number
74625|NCT01062061|Primary|Percentage of Participants With One or More Unexpected SAEs|Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination|||percentage of participants|||Number
74626|NCT01062061|Primary|Percentage of Participants With One or More Serious ADRs|A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|Serious ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
74627|NCT01062061|Primary|Percentage of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.|Up to 42 days after vaccination|SAEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
74628|NCT01062061|Primary|Percentage of Participants With One or More Unexpected ADRs|An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out|Up to 42 days after vaccination|Unexpected ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
74629|NCT01062061|Primary|Percentage of Participants With One or More Unexpected AEs|Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination|Unexpected AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
74630|NCT01062061|Primary|Percentage of Participants With One or More Adverse Drug Reactions (ADRs)|An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
74631|NCT01062061|Primary|Percentage of Participants With One or More AEs by Age|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
74700|NCT01060540|Secondary|Perceived Lifetime Risk of Type 2 Diabetes|measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)|3 months|||units on a scale||Standard Deviation|Mean
74632|NCT01062061|Primary|Percentage of Participants With One or More AEs by Gender|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||percentage of participants|||Number
74633|NCT01062061|Primary|Percentage of Participants With One or More Adverse Events (AEs)|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow||Percentage of Participants|||Number
74634|NCT01061866|Primary|Change From Baseline in the Mean Number of Daily Seizures at 1 Year.||Baseline 3 months and 1 year of treatment|males of 25 years old mean with refractory epilepsy, antiepileptic treatment and electroencephalographic study||Number of Seizures||Standard Error|Mean
74635|NCT01061775|Secondary|Calorie Intake Based on 3-day Diet Records|Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.|24 weeks|The sample size was small due to missing data||kcals||95% Confidence Interval|Mean
74636|NCT01061775|Secondary|Childhood Eating Behavior Questionnaire (CEBQ)|The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.|24 weeks|Paired t-tests were performed to compare the satiety survey (continuous). Three subjects discontinued prior to completing the Week 24 CEBQ.||units on a scale||95% Confidence Interval|Mean
74637|NCT01061775|Primary|Waist to Height Ratio (WHtR)|Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks|24 weeks|All analyses were performed using SPSS (version 20.0.0, SPSS Inc, Chicago, IL).||percentage||Standard Deviation|Mean
74638|NCT01061775|Primary|BMI Change|BMI was collected at baseline and 24 weeks|24 weeks|The effects of exenatide on BMI were analyzed using a paired t-test comparing BMI at baseline with BMI after six months of treatment with each patient serving as his or her own control.||kg/m^2||95% Confidence Interval|Mean
74639|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Proportion of Responders||24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed.|||||
74640|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)||24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed.|||||
74641|NCT01061710|Secondary|Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert|An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.||Participants|||Number
74642|NCT01061710|Primary|Number of Responders to Varenicline Treatment|Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.|24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population.||Participants|||Number
74643|NCT01061710|Primary|Number of Participants With Treatment-Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.||Participants|||Number
74644|NCT01061671|Secondary|Pharmacogenetics and Pharmacoepigenetics of Statin Therapy in COPD||one time point within study period||||||
74645|NCT01061671|Secondary|The Effect of Current Smoking Status on Inflammatory Biomarker Levels and Response to Simvastatin Treatment||up to 37 months||||||
74646|NCT01061671|Secondary|Rate of Combined Cardiovascular Events||up to 37 months||||||
74647|NCT01061671|Secondary|Systemic and Lung-specific Biomarkers of Inflammation and Procoagulant Activity||up to 37 months||||||
74654|NCT01061606|Secondary|Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient’s Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented|Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years|The study concluded terminated early and patients were not followed.|||||
74655|NCT01061606|Secondary|Overall Survival|Time to event distributions will be estimated using the Kaplan-Meier method.|From registration to death, assessed up to 3 years|The study concluded terminated early and patients were not followed.|||||
74656|NCT01061606|Primary|Progression Free Survival|The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.|6 months from registration|The study concluded terminated early and patients were not followed.|||||
74657|NCT01061606|Primary|Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST||Up to 3 years|||participants|||Number
74658|NCT01061567|Secondary|Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score|The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3.||units on a scale||Standard Deviation|Mean
74659|NCT01061567|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction|The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in VAS at baseline and at visit 3.||units on a scale||Standard Deviation|Mean
74660|NCT01061567|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder Rate|The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson’s disease. The clinician rated how much a patient’s condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.|Baseline and the end of study (up to 16 weeks)|Patients from FAS||percentage of participants|||Number
74661|NCT01061567|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score|Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.|Baseline and the end of study (up to 16 weeks)|Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit.||units on a scale||Standard Deviation|Mean
74662|NCT01061567|Primary|Proportion of Patients With Withdrawals Due to Adverse Events.|Patients who discontinued treatment due to adverse events including deaths.|16 weeks|Patients from the Treated Set (TS).||proportion of participants|||Number
74663|NCT01061567|Primary|Incidence of Adverse Events|The number of patients with any adverse events (AEs), patients with drug-related AEs.|From the treatment initiation to the end of study, on average 92.9 days|Patients from the Treated Set (TS).||participants|||Number
74664|NCT01061476|Primary|Change in AHI|The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).|Comparisons were made between the 2 nights|Although all participants went through the sleep studies, there was insufficient data in 1 subject to assess sleep apnea severity and was therefore excluded from analysis.||events/h||Standard Deviation|Mean
74665|NCT01061385|Secondary|Percentage of Subjects With >=25% Excess Weight Loss (EWL)|a between-group comparison of percentage of treatment subjects achieving >=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving >= 25%EWL at 12 months|12 months|||percentage of subjects|||Number
74666|NCT01061385|Primary|%Excess Weight Loss|the difference between the %EWL between treatment and control groups must be clinically significant|36 Weeks|||percent excess weight loss||Standard Deviation|Mean
74667|NCT01061359|Secondary|Time to Recurrence (DFI)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Median time to recurrence was not reached.||months||Full Range|Median
74668|NCT01061359|Secondary|Time to Progression (TTP)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|16.3% of patients had experienced disease progression by the end of the study. As this is less than 50% the median time to progression is not defined.||months||Full Range|Median
74669|NCT01061359|Primary|Percentage of Participants With Disease Free Survival (DFS)|Percentage of participants with DFS who completed 5 year follow-up visit.|3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Intent to treat (ITT)||Percentage of participants|||Number
74670|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTE4|Concentrations of LTE4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.||pg/mL||Standard Deviation|Geometric Mean
74671|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTD4|Concentrations of LTD4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.||pg/mL||Standard Deviation|Geometric Mean
74672|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTC4|Concentrations of LTC4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.||pg/mL||Standard Deviation|Geometric Mean
74674|NCT01061333|Secondary|Allergen-induced Changes in Urinary 9P|Fold change over baseline in Urinary 9P at 2 hours post allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed||Fold change over baseline||Standard Deviation|Geometric Mean
74675|NCT01061333|Primary|Change in Plasma 9P at 20 Minutes|Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge|Pre-allergen challenge and 20 minutes post allergen challenge|||Fold change over baseline||Standard Deviation|Geometric Mean
74676|NCT01061333|Primary|Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes|Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge|Pre-allergen challenge and 5 minutes post allergen challenge|||Fold change over baseline||Standard Deviation|Geometric Mean
74677|NCT01061333|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Maximal percent drop in FEV1 at 20 minutes post allergen challenge|Pre-allergen challenge and 20 minutes after allergen challenge|||Percentage drop in FEV1||Standard Deviation|Least Squares Mean
74678|NCT01061034|Secondary|Platelet Function Tests|"Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.~the results reflects the percent of active platelets."|on day 0 as a baseline and on day 7 and 21 of the study.|||percent||Standard Deviation|Mean
74679|NCT01061034|Primary|Aspirin Level in Blood (Area Under the Curve)|"Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.~The area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin."|on day 7,on day 21|9 volunteers completed the study, one volunteer was excluded from pharmacokinetics, because serum salicylic acid concentration was not at the baseline (non-detectable) in the 0-hour sample.||mg*hour/mL||Standard Deviation|Mean
74680|NCT01061008|Secondary|Forearm Muscle Cross Sectional Area||3 months||||||
74681|NCT01061008|Secondary|Handgrip Endurance||3 months||||||
74682|NCT01061008|Secondary|Maximum Handgrip Strength||3 months||||||
74683|NCT01061008|Primary|Venous Diameter.|Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese & Nonnast-Daniel, 2004).|3 months|||mm||Standard Deviation|Mean
74684|NCT01060670|Secondary|Change in Short Form Health Survey (SF-36) Quality of Life Metrics|Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.|Baseline and 16 weeks|ITT Population||units on a scale||Standard Deviation|Mean
74685|NCT01060670|Secondary|Incidence of Ulcer Recurrence|Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.|12 weeks|ITT Population complete wound healed||participants|||Number
74686|NCT01060670|Secondary|Rate of Wound Closure|Rate of wound closure as assessed by computerized planimetry|16 weeks|ITT Population||percentage wound closure/week||Standard Deviation|Mean
74687|NCT01060670|Secondary|Time to Complete Wound Closure|Time to complete wound closure, as assessed by computerized planimetry.|16 weeks|ITT population complete wound healed with analyzable data||days||Full Range|Median
74688|NCT01060670|Secondary|Time to Complete Wound Closure|Measures the time to complete wound closure as assessed by the Investigator.|16 weeks|ITT Population complete wound healed with analyzable data||days||Standard Deviation|Mean
74689|NCT01060670|Secondary|Incidence of Complete Wound Closure|Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.|16 weeks|ITT Population||percentage of subjects|||Number
74690|NCT01060670|Primary|Incidence of Complete Wound Closure|100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.|16 weeks|The results were based on the Investigator assessment and ITT population.||participants|||Number
74691|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Small Bands Only)||12m post surgery|||%EWL||Standard Deviation|Mean
74692|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)||12m post surgery|||%EWL||Standard Deviation|Mean
74693|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)||4-6 weeks post surgery|||%EWL||Standard Deviation|Mean
74694|NCT01060592|Secondary|Number of Band Adjustments Required in the First Year After Surgery||12 months|||Number of Adjustments||Standard Deviation|Mean
74695|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)||4-6 weeks post surgery|||%EWL||Standard Deviation|Mean
74696|NCT01060553|Secondary|Pittsburgh Sleep Index|subscales range from 0 to 3 with higher being worse.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis||units on a scale||Standard Deviation|Mean
74697|NCT01060553|Primary|SF-36|global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis.||units on a scale||Standard Deviation|Mean
74698|NCT01060540|Secondary|Moderate Intensity Physical Activity|self-report based on the long version of the International Physical Activity Questionnaire. Moderate physical activity was queried in the domains of work (e.g., carrying light loads), transportation (e.g., bicycling), domestic chores and gardening (e.g., sweeping, raking), and leisure-time (e.g., bicycling, swimming).|3 months|||minutes per week||Standard Deviation|Mean
74699|NCT01060540|Secondary|Daily Caloric Intake|Estimated daily caloric intake based on self-reported frequency and amount of intake of specific foods over the past 3 months as assessed by the Block Brief Food Frequency Questionnaire|3 months|||kcal||Standard Deviation|Mean
74701|NCT01060540|Secondary|Insulin Resistance (HOMA2-IR)|"Calculated using the updated homeostasis model assessment (HOMA) calculator at http://www.dtu.ox.ac.uk/homacalculator/~Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance."|3 months|||units on a scale||Standard Deviation|Mean
74702|NCT01060540|Primary|Weight|weight 3 months post-enrollment|3 months|||kg||Standard Deviation|Mean
74703|NCT01060150|Secondary|Stroop Test Score for Ratio Interference|Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
74704|NCT01060150|Secondary|Stroop Test Result for False Reaction|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Errors||Standard Deviation|Mean
74705|NCT01060150|Secondary|Stroop Test Result for Reaction Time|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Seconds||Standard Deviation|Mean
74706|NCT01060150|Secondary|Controlled Oral Words Association Test (COWAT) Score|This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Words||Standard Deviation|Mean
74707|NCT01060150|Secondary|Finger Window (FW) Test Score|In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
74708|NCT01060150|Secondary|Digit Span Test Score|Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
74709|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor’s score is over 65 point, the participant is resulted in having attention deficit.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on scale||Standard Deviation|Mean
74746|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
92762|NCT00879814|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Baseline up to Month 7|||percentage of participants|||Number
74710|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Errors||Standard Deviation|Mean
74711|NCT01060150|Primary|Learning Skill Test (LST) Total Score|The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||T-score||Standard Deviation|Mean
74712|NCT01060150|Primary|Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
74713|NCT01060150|Primary|Clinical Global Impression - Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF.||Units on a scale||Standard Deviation|Mean
74714|NCT01060150|Primary|Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score|The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.|Week 12|Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
74715|NCT01060124|Other Pre-specified|Number of Participants With Investigator's Overall Evaluation on the Pain Treatment|Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.|Day 29|Full Analysis (FAS) population included all those participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
74716|NCT01060124|Other Pre-specified|Initial and End Point Dose of TTS-Fentanyl D-trans|Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.|Day 1 and Day 29|Safety population included all participants who were administered the TTS-fentanyl D-trans at least once.||microgram per hour (mcg/hr)||Standard Deviation|Mean
74717|NCT01060124|Other Pre-specified|Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment|Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.|Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
74718|NCT01060124|Secondary|Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans|Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.|Day 1 and Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
74719|NCT01060124|Primary|Percentage of Participants Satisfied With Pain Treatment|Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.|Day 29|Per-Protocol (PP) analysis population included all participants who completed the clinical trial without violating the protocol among the participant who participated in the clinical trial.||percentage of participants||95% Confidence Interval|Number
74720|NCT01060111|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6|VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating “no headache” and the other end with 10 points indicating “unimaginably strong headache.” It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a Scale||Standard Deviation|Mean
74721|NCT01060111|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6|MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
74722|NCT01060111|Secondary|Change From Baseline in Migraine Frequency at Week 6|The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Migraine episodes/Week||Standard Deviation|Mean
74723|NCT01060111|Primary|Percentage Decrease in Migraine Episodes|Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS).|Maintenance period (Weeks 7 to 10)|The intent-to-treat (ITT) population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'N' signifies participants who were evaluated for this outcome measure.||Percentage decrease in migraine episodes||Standard Deviation|Mean
74724|NCT01060072|Secondary|Resolution of Anterior Chamber Flare|Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)||participants|||Number
74725|NCT01060072|Secondary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain|Visits 4-7 (Postoperative days 3-18)|Intention to treat population (ITT)||participants|||Number
74726|NCT01060072|Secondary|Resolution of Anterior Chamber Cells|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)||participants|||Number
74727|NCT01060072|Primary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population||participants|||Number
74728|NCT01060072|Primary|Resolution of Anterior Chamber Cells.|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population||participants|||Number
74729|NCT01060059|Secondary|Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline|Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FASS=444 and 438 in each arm respectively but the number of patients with creatinine and fasting lipids data at baseline varied. N is presented with each category.||mg/dL||Standard Deviation|Mean
74730|NCT01060059|Secondary|Factor of Greater Height Associated With Treatment Choice at Baseline|Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not provide height data so n=437."||cm||Standard Deviation|Mean
74731|NCT01060059|Secondary|Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m^2.|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not have data in this arm so n=437."||kg/m^2||Standard Deviation|Mean
74732|NCT01060059|Secondary|Factor of Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.||years||Standard Deviation|Mean
74733|NCT01060059|Secondary|Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline|The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.||years||Standard Deviation|Mean
74734|NCT01060059|Secondary|Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline|Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS=444, however 1 patient in the exenatide arm was missing data for the most recent HbA1c at baseline so n=443."||Percentage of normal||Standard Deviation|Mean
74735|NCT01060059|Secondary|Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline|Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.|baseline|All patients consented to release information; fulfilled study entry criteria. Analyses conducted on baseline arm assignment, irrespective of later treatment changes. Only those assigned to an arm were included. Missing values for numeric covariates replaced with means; categorical ones, with modes.||participants|||Number
74736|NCT01060059|Secondary|Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12|"Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.~All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected."|Baseline to Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
74737|NCT01060059|Secondary|Changes in Systolic Blood Pressure Between Baseline and Month 12|Changes in Systolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mmHg||Standard Deviation|Mean
74738|NCT01060059|Secondary|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mmHg||Standard Deviation|Mean
74739|NCT01060059|Secondary|Changes in Fasting Triglycerides Between Baseline and Month 12|Changes in Fasting Triglycerides Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
74740|NCT01060059|Secondary|Changes in Fasting LDL Between Baseline and Month 12|Changes in Fasting LDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
74741|NCT01060059|Secondary|Changes in Fasting HDL Between Baseline and Month 12|Changes in Fasting HDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
74742|NCT01060059|Secondary|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||mg/dL||Standard Deviation|Mean
74743|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
74744|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
74745|NCT01060059|Secondary|Changes in Weight From Baseline to Month 12|Changes in Weight From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||kg||Standard Deviation|Mean
75105|NCT01056315|Secondary|Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).||Baseline, Last 7 days of 12-week maintenance||||||
74747|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
74748|NCT01060059|Secondary|Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12|Percentage of Patients with HbA1c Reduction from Baseline >= 1.0% at Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"||percentage of patients|||Number
74749|NCT01060059|Secondary|Changes in Fasting Blood Glucose From Baseline to Month 12|Changes in Fasting Blood Glucose From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."||mg/dL||Standard Deviation|Mean
74750|NCT01060059|Secondary|Changes in HbA1c From Baseline to Month 12|Changes in HbA1c from Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."||percent||Standard Deviation|Mean
74751|NCT01060059|Primary|Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.|Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."||percentage of patients||95% Confidence Interval|Number
74752|NCT01060007|Secondary|Determine Quality of Anorectal Function||1 year||01/2016||||
74753|NCT01060007|Secondary|Freedom From Disease Relapse|Kaplan-Meier projections.|30 months|These include all cMO evaluable cases only.||percentage of participants||95% Confidence Interval|Number
74754|NCT01060007|Secondary|Rate of Locoregional Control||1 year|||percentage of participants|||Number
74755|NCT01060007|Secondary|Rate of Overall Control||1 year|||percentage of participants|||Number
74756|NCT01060007|Secondary|Local Control|Kaplan-Meier projections|30 months|||percentage of participants||95% Confidence Interval|Number
74757|NCT01060007|Secondary|Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity||1 year (completion of all treatment)|||participants|||Number
74758|NCT01060007|Secondary|Incidence of Any Late Grade 3 or Higher Morbidity||Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.||participants|||Number
74759|NCT01060007|Primary|Preoperative Gastrointestinal Morbidity|As measured by participants who experience grade 3 or higher gastrointestinal morbidity|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.||participants|||Number
74760|NCT01060007|Primary|Rate of T Stage Downstaging|T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)|||percentage of participants|||Number
74761|NCT01059994|Secondary|Protein Synthesis|Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time)|2 weeks|||% synthesized of total/hour||Standard Deviation|Mean
74762|NCT01059994|Primary|Muscle Fatigue|successful isokinetic knee extension repetitions, % baseline day repetitions|2 weeks|||successful repetitions (% baseline day)||Standard Deviation|Mean
74763|NCT01059903|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.|24 hours|Pharmacokinetic Set (PKS)||mg||Standard Deviation|Mean
74764|NCT01059903|Secondary|Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine|The CL/f of unconjugated rotigotine is the apparent total body clearance.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||L/ h||Standard Deviation|Mean
74765|NCT01059903|Secondary|Terminal Half-Life (t1/2) of Unconjugated Rotigotine|the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||hours (h)||Standard Deviation|Mean
74766|NCT01059903|Secondary|Rate Constant of Elimination (λz) of Unconjugated Rotigotine|The λz of unconjugated rotigotine is the rate constant of elimination.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||1/ h||Standard Deviation|Mean
74767|NCT01059903|Secondary|Mean Residence Time (MRT) of Unconjugated Rotigotine|The MRT is the mean residence time.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||hours (h)||Standard Deviation|Mean
74768|NCT01059903|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach maximum plasma concentration after patch application.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||hours (h)||Standard Deviation|Mean
74769|NCT01059903|Secondary|Cmax, Norm (Body Weight) of Unconjugated Rotigotine|The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*kg||Standard Deviation|Mean
74770|NCT01059903|Secondary|Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL/ mg||Standard Deviation|Mean
74771|NCT01059903|Secondary|AUC(0- ∞) Norm (Body Weight)|The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng*h*kg/ mL||Standard Deviation|Mean
74772|NCT01059903|Secondary|AUC(0- ∞) Norm (Apparent Dose)|The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h/ mg||Standard Deviation|Mean
74773|NCT01059903|Secondary|AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng*h*kg/ mL||Standard Deviation|Mean
74774|NCT01059903|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h/ mg||Standard Deviation|Mean
74775|NCT01059903|Primary|AUC(0- ∞) of Unconjugated Rotigotine|The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h||Standard Deviation|Mean
74776|NCT01059903|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL||Standard Deviation|Mean
74777|NCT01059903|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)||ng/ mL*h||Standard Deviation|Mean
74778|NCT01059864|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||units on a scale||Standard Deviation|Mean
74779|NCT01059864|Secondary|Patient's Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain."|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm||Standard Deviation|Mean
74780|NCT01059864|Secondary|Physician's Global Assessment (PhysGA) of Arthritis Pain|The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient’s global assessment of arthritis. Physician’s response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm||Standard Deviation|Mean
74781|NCT01059864|Secondary|Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm||Standard Deviation|Mean
74782|NCT01059864|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mm/hr||Standard Deviation|Mean
74783|NCT01059864|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mg/L||Standard Deviation|Mean
75106|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance||Baseline, Daily scores over entire 12 week maintenance||||||
74784|NCT01059864|Secondary|Swollen-Joint Count|Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||swollen joints||Standard Deviation|Mean
74785|NCT01059864|Secondary|Tender-Joint Count|Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||tender joints||Standard Deviation|Mean
74786|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||percentage of participants|||Number
74787|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||percentage of participants|||Number
74788|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||percentage of participants|||Number
74789|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) [mm/hr] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) <=3.2 indicated low disease activity, DAS28-4 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
74790|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). DAS28-3 (ESR) <=3.2 indicated low disease activity, DAS28-3 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-3(ESR) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.|||||
74791|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) [mg/L] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 [CRP] <=3.2 indicated low disease activity, DAS28-4 [CRP] >3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-4(CRP) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.|||||
74792|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter [mg/L]). DAS28-3 (CRP) less than or equal to (<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (>) 3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||units on a scale||Standard Deviation|Mean
74793|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||micromole per liter (mcmol/L)||Standard Deviation|Mean
75107|NCT01056315|Primary|Average Pain Intensity|The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).|Baseline; last 7 days of 12-week maintenance||||||
74794|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||nanomoles per liter (nmol/L)||Standard Deviation|Mean
74795|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||nanometer (nm)||Standard Deviation|Mean
74796|NCT01059864|Secondary|12-Hours Fasting Lipid Profile|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).||mg/dL||Standard Deviation|Mean
74797|NCT01059864|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline (Week 6), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
74798|NCT01059864|Primary|Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12||Baseline (Week 6), Week 12|Full analysis set (FAS) included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||percent change||Standard Error|Least Squares Mean
74799|NCT01059851|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
74800|NCT01059851|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
74801|NCT01059851|Primary|AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|Per protocol, the decision to conduct Part II of study in moderate/mild renal impairment participants was conditional on results of AUC (0-∞) analysis in severe renal impairment participants (Part I). Based on results of Part I of study, Part II was not conducted and AUC(0-∞) analysis in moderate/mild renal impairment was not done.|||||
74802|NCT01059851|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|All Treated Participants||μM•hr||95% Confidence Interval|Geometric Mean
74803|NCT01059812|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||kg||Standard Deviation|Mean
74804|NCT01059812|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
74805|NCT01059812|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
74861|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74806|NCT01059812|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 24 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
74807|NCT01059812|Primary|Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74808|NCT01059799|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects.The missing data is imputed using last observation carried forward (LOCF). For 25 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
74809|NCT01059799|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
74810|NCT01059799|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
74811|NCT01059799|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
74812|NCT01059773|Secondary|Proportion of Patients Achieving PASI 90 Response|This is based on the number of participants achieving at least 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.||Percentage of participants||95% Confidence Interval|Number
74813|NCT01059773|Secondary|Proportion of Patients Achieving PASI 75 Response|This is based on the number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.||Percentage of participants||95% Confidence Interval|Number
74814|NCT01059773|Secondary|Proportion of Patients Achieving PASI 50 Response|This is based on the number of participants achieving at least 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.||Percentage of participants||95% Confidence Interval|Number
74815|NCT01059773|Secondary|Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline|Change from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 0, 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis||Units on a scale||Standard Deviation|Mean
74816|NCT01059773|Secondary|Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)|The number of patients with a malignancy and other event of clinical interest (tuberculosis, serious cardiovascular events, anaphylactic/serum sickness reaction) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg)|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information||Number of patients|||Number
74879|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Day 122 and Day 304|||Subjects|||Number
74817|NCT01059773|Secondary|Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): infections, serious infections, and infections requiring oral or parenteral antimicrobial treatment (infections being considered any event that by the investigator was indicated as infection on the CRF).|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information||Number of patients|||Number
74818|NCT01059773|Primary|Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12||from week 0 to week 12|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.||participants|||Number
74819|NCT01059773|Secondary|Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE with severe intensity; AE or SAE reasonably related to ustekinumab (i.e., AEs classified by the investigator as ‘possibly’, ‘probably’, or ‘very likely’ related to study agent); AE or SAE leading to permanent discontinuation of ustekinumab.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information||Number of patients|||Number
74820|NCT01059773|Secondary|Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period|The number of patients with any of the following Treatment Emergent AEs (TEAEs) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE; SAE and Death.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.||Number of patients|||Number
74821|NCT01059630|Secondary|Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores|FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0−116). FACT-Lym total score is sum of 42 items (total score ranges from 0−168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).|Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), and 12 (FUM12)|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.||Percentage of participants|||Number
74822|NCT01059630|Secondary|Time to Deterioration of FACT-Lym TOI|The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline up to approximately 4 years (Baseline, Day 1 of Cycles 1, 3, 4, 5, EOI treatment [up to Month 6]; Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up [up to 2 years after EOI]; Extension follow-up Months 6 and 18)|ITT population.||Months||95% Confidence Interval|Median
74823|NCT01059630|Secondary|CFB in FACT-Lym Total Score|FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0−168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||Units on a scale||Standard Deviation|Mean
74824|NCT01059630|Secondary|CFB in FACT-Lym Trial Outcome Index (TOI)|TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0−116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||Units on a scale||Standard Deviation|Mean
74904|NCT01059565|Secondary|Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events|The total number of systemic and/or inhaled antibiotic courses for respiratory events from baseline to Week 24 was analyzed. A single antibiotic course may represent the use of multiple antibiotics.|Baseline to Week 24|Full Analysis Set||antibiotic treatment courses|||Number
74825|NCT01059630|Secondary|CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score|The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||Units on a scale||Standard Deviation|Mean
74826|NCT01059630|Secondary|CFB in EQ-5D VAS Score During Maintenance Phase|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for ‘Obinutuzumab + Bendamustine’ arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74827|NCT01059630|Secondary|CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For ‘Obinutuzumab + Bendamustine’ arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under “CFB at Follow-up Month 2” and “CFB at Follow-up Month 4” categories.|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2 and 4|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74828|NCT01059630|Secondary|CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for ‘Obinutuzumab + Bendamustine’ arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase."|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74829|NCT01059630|Secondary|CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For ‘Obinutuzumab + Bendamustine’ arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under “CFB at Follow-up Month 2” and “CFB at Follow-up Month 4” categories."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, and 4|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74830|NCT01059630|Secondary|CFB in FACT-Lym-Lymphoma Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
75183|NCT01055171|Secondary|Proportion of Drinking Days|Proportion of drinking days from 90 days prior to the screening to the follow-up period.|90 days prior to participation in study up to 2-week follow up session (Session 3)|||Drinking days||Standard Error|Mean
74831|NCT01059630|Secondary|CFB in FACT-Lym-Functional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74832|NCT01059630|Secondary|CFB in FACT-Lym-Emotional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74833|NCT01059630|Secondary|CFB in FACT-Lym-Social/Family Well-being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74834|NCT01059630|Secondary|Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.||units on a scale||Standard Deviation|Mean
74835|NCT01059630|Secondary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until death (up to 4.5 years overall)|ITT population.||months||95% Confidence Interval|Median
74836|NCT01059630|Secondary|Percentage of Participants Who Died||Baseline until death (up to 4.5 years overall)|ITT population.||percentage of participants|||Number
74837|NCT01059630|Secondary|Event-free Survival (EFS) as Assessed by IRC|EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||months||95% Confidence Interval|Median
74850|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response were also calculated with 95% CI, for both pooled Flulaval (Flulaval/Arepanrix + Flulaval/Unadjuvanted Arepanrix Groups) and Placebo (Placebo/Arepanrix + Placebo/Unadjuvanted Arepanrix Groups) treatment groups at Days 0, 7, 14 and 21 up to the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14 and 21|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
74838|NCT01059630|Secondary|Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC|DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.||months||95% Confidence Interval|Median
74839|NCT01059630|Secondary|Duration of Response (DoR) as Assessed by IRC|DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.||months||95% Confidence Interval|Median
74840|NCT01059630|Secondary|Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC and Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.||percentage of participants||95% Confidence Interval|Number
74841|NCT01059630|Secondary|Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC and Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.||percentage of participants||95% Confidence Interval|Number
74842|NCT01059630|Secondary|Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC and Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 12 months overall)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
74860|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine. Missing values will be added once they become available.|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74843|NCT01059630|Secondary|Percentage of Participants With Objective Response as Assessed by IRC and Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 12 months overall)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.||percentage of participants||95% Confidence Interval|Number
74844|NCT01059630|Secondary|PFS as Assessed by Investigator|PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||months||95% Confidence Interval|Median
74845|NCT01059630|Secondary|Number of Participants With PD or Death as Assessed by Investigator|PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||participants|||Number
74846|NCT01059630|Primary|Progression-Free Survival (PFS) as Assessed by IRC|PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||months||95% Confidence Interval|Median
74847|NCT01059630|Primary|Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death|PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.||participants|||Number
74848|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
74849|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74851|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.~Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response were also calculated for both pooled Flulaval (Flulaval/Arepanrix + Flulaval/Unadjuvanted Arepanrix Groups) and Placebo (Placebo/Arepanrix + Placebo/Unadjuvanted Arepanrix Groups) treatment groups at Days 0, 7, 14 and 21 up to the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14 and 21|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74852|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
74853|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74854|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response were also calculated with 95% CI, for both pooled Flulaval (Flulaval/Arepanrix + Flulaval/Unadjuvanted Arepanrix Groups) and Placebo (Placebo/Arepanrix + Placebo/Unadjuvanted Arepanrix Groups) treatment groups at Days 0, 7, 14 and 21 up to the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14 and 21|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
74855|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.~Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response were also calculated for both pooled Flulaval (Flulaval/Arepanrix + Flulaval/Unadjuvanted Arepanrix Groups) and Placebo (Placebo/Arepanrix + Placebo/Unadjuvanted Arepanrix Groups) treatment groups at Days 0, 7, 14 and 21 up to the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14 and 21|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74856|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), creatinine (CREA), blood urea nitrogen (BUN), and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|||Subjects|||Number
74857|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|||Subjects|||Number
74858|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatise (AP), creatinine (CREA), blood urea nitrogen (BUN) and bilirubin (BIL) (total (T) and direct (D)).~For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated)."|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74859|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
75196|NCT01054976|Primary|Change From Baseline in Simple Reaction Time|The Simple Reaction Time is a computerized attention test that evaluates the patient’s reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.|Baseline, Week 12|Per-protocol (PP) analysis set.||seconds||Standard Deviation|Mean
74862|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Flulaval vaccine or placebo dose. Missing values will be added once they become available.|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74863|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Flulaval vaccine or placebo dose. Missing values will be added once they become available.|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74864|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74865|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74866|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination. Missing values will be added once they become available.|Up to Day 234|||Subjects|||Number
74867|NCT01059617|Secondary|Case Descriptions for Subjects Experiencing Reverse Transcription-polymerase Chain Reaction (RT-PCR) and Culture-confirmed Influenza.||During the entire study period (up to Day 507).||09/2012||||
74868|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).|||Subjects|||Number
74869|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"Unsolicited AEs were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.~An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."|Within 84 days following first dose or 63 days following second dose of vaccine.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74870|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"Unsolicited AEs were collected after the administration of the Flulaval vaccine or the placebo dose.~An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."|Up to 21-day (Days 0-20) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
74871|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).|||Subjects|||Number
74872|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).|||Subjects|||Number
74873|NCT01059617|Secondary|Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).||For the entire study period up to Day 507||09/2012||||
74874|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.||For the entire study period up to Day 507||09/2012||||
74875|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 0 and Day 304|||Titers||95% Confidence Interval|Geometric Mean
74876|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Day 0 and Day 304|||Subjects|||Number
74877|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.||For the entire study period up to Day 507||09/2012||||
74878|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 122 and Day 304|||Titers||95% Confidence Interval|Geometric Mean
74880|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28 These data were not available. This summary will be updated when the results become available.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).||09/2012||||
74881|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
74882|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74883|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164 to Day 122).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Fold||95% Confidence Interval|Geometric Mean
74884|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74885|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74886|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28 These data were not available. This summary will be updated when the results become available.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).||09/2012||||
74887|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Titers||95% Confidence Interval|Geometric Mean
74888|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74905|NCT01059565|Primary|AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24|The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24.|Baseline to Week 24|Full Analysis Set||percent change in FEV1% predicted||Standard Error|Least Squares Mean
83763|NCT00967551|Secondary|Proportion of Children With Respiratory Infections|Number of children with respiratory infections divided by the total number of children in the group|6 months|All children enrolled||percentage of participants|||Number
74889|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164 to Day 122).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Fold||95% Confidence Interval|Geometric Mean
74890|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74891|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).||Subjects|||Number
74892|NCT01059565|Secondary|Percentage of Missed School or Work Days|The percentage of days participants missed school or work from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of days||Standard Deviation|Mean
74893|NCT01059565|Secondary|Percent of Days Hospitalized|The percentage of days hospitalized from baseline to Week 24 was analyzed.|Baseline to Week 24|Full Analysis Set||percentage of days||Standard Deviation|Mean
74894|NCT01059565|Secondary|Percentage of Days Participants Used Antibiotics|The percentage of days participants used antibiotics from baseline to Week 24 was analyzed. Antibiotics ongoing at baseline or started on or after first dose date were included in the analysis. A single antibiotic course could represent the use of multiple antibiotics. Days of antibiotic use included unique days.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.||percentage of days||Standard Deviation|Mean
74895|NCT01059565|Secondary|Change in Burkholderia Spp. CFU in Sputum From Baseline to Week 24|The change in Burkholderia spp. CFU in sputum from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||log_10 CFU per gram of sputum||Standard Error|Least Squares Mean
74896|NCT01059565|Secondary|Change in BMI From Baseline to Week 24|The change in BMI from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||kg/m^2||Standard Error|Least Squares Mean
74897|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Treatment Burden Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the treatment burden score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R treatment burden domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
74898|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Weight Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the weight score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R weight domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
74899|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Physical Functioning Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the physical functioning score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R physical functioning domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
74900|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEF25-75|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEF25-75 was analyzed. FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||percent change in FEF25-75 (liters/sec)||Standard Error|Least Squares Mean
74901|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FVC|The relative change (AUCave) from baseline to Week 24 in mean (SE) FVC was analyzed. FVC is defined as the volume of air that can forcibly be blown out after taking a full breath.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||percent change in FVC (liters)||Standard Error|Least Squares Mean
74902|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEV1|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEV1 was analyzed. FEV1 is defined as the maximal volume of air that can be exhaled in 1 second.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||percent change in FEV1 (liters)||Standard Error|Least Squares Mean
74903|NCT01059565|Secondary|AUCave of Change in CFQ-R RSS Scores From Baseline to Week 24|"The change (AUCave) in CFQ-R RSS scores from baseline to Week 24 was analyzed.~The range of scores (units) within the RSS domain is 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.||units on a scale||Standard Error|Least Squares Mean
74906|NCT01059526|Secondary|Overall Patient Response Assessment|The Overall Response Assessment was to be completed every 30 minutes after treatment until patient discharge. Patients evaluated their response to treatment as “a lot better or resolved,” “a little better,” “the same,” “a little worse,” or “a lot worse.” The data presented is based on the best response achieved following a single dose of KALBITOR (Dose A) for the first HAE treatment episode. Responses of “a lot better or resolved” and “a little better” were combined to form a category of “Better.” Similarly, “a little worse” and “a lot worse” were combined to form a category of “Worse.” Patients treated in a clinic (study site) could have been discharged after an hour and hence may have only had 2 post-treatment evaluations (30 and 60 minutes); response assessments may not have been consistently provided when patients were treated at an alternate site outside of the study site.|within 4 hours post dose|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR. Analysis only includes episodes of patients who were treated at the study site.||participants|||Number
74907|NCT01059526|Primary|Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR|Events of ecchymosis, hemorrhage, petechiae, spontaneous hemorrhage, hematoma, gastrointestinal bleeding, hemorrhagic stroke and any other term indicative of a bleeding event or increased tendency for bleeding were reviewed to determine the occurrence of hypocoagulability. Events of clotting, thrombosis, pulmonary embolism, vaso-occlusive stroke, myocardial infarction, and any other term indicative of a clotting event or increased risk of clotting were reviewed to determine the occurrence of hypercoagulability.|12 months after first treatment|||participants||95% Confidence Interval|Number
74908|NCT01059526|Primary|Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.|"Seroconversion is the development of detectable specific antibodies in the blood serum. Serum was tested for development of antibodies (irrespective of immunoglobulin class) against ecallantide at screening and at all safety evaluations. Positive results were to undergo a confirmatory test. Confirmed positive samples were further titered. Patients who developed an antibody response were evaluated for the development of neutralizing antibodies.~Patients also had their serum analyzed for IgE-specific antibodies to ecallantide at screening and during safety evaluations. Positive results underwent a confirmatory test. Confirmed positive samples were further titered."|12 months after first treatment|Based on total number of patients who were not positive for the antibody class at study entry and had at least one post-baseline antibody evaluation. N=40 evaluable patients for all immunoglobulin antibody classes; N=41 evaluable patients for IgE to ecallantide antibodies; N=41 evaluable patients for neutralizing antibodies to ecallantide.||participants||95% Confidence Interval|Number
74909|NCT01059526|Primary|Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity|Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients with any of these TEAE referred terms were reviewed further to assess potential hypersensitivity reactions, considering factors such as timing of TEAEs in relationship to dose (ie, occurred within 24 hours after start of KALBITOR treatment), accompanying symptoms, Investigator causality assessment (ie, reported as possibly, probably, or definitely related to study drug), and any other available clinical information. Anaphylaxis subset determined based on criteria established by the NIAID.|12 months after first treatment|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR||participants||95% Confidence Interval|Number
74910|NCT01059071|Secondary|AUC of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID||(mcg/ml) * hr||Standard Deviation|Mean
74911|NCT01059071|Secondary|Cmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID||mcg/ml||Standard Deviation|Mean
74912|NCT01059071|Secondary|Tmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID||hours||Standard Deviation|Mean
74913|NCT01059071|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.||participants|||Number
74914|NCT01059071|Secondary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.||Days||95% Confidence Interval|Median
74915|NCT01059071|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of DFMO as a single agent and in combination with etoposide in pediatric and young adult patients with refractory or recurrent neuroblastoma|length of study plus 30 days|Received at least one dose of DFMO||participants|||Number
74916|NCT01058993|Primary|Blood Neutrophil Counts.|Effectiveness of drug based on increases of blood neutrophil counts to greater than 2.0 x 10^9 per liter|up to 14 days, depending on when subject reached peak response, i.e., the highest count after the stimulus (plerixafor)|The number of participants (6) was determined by the fact that we were studying a rare form of neutropenia, WHIMS syndrome, and we therefore recruited subjects who have WHIMS who live on the West coast. Analysis was per protocol.||10^9 per Liter||Standard Deviation|Mean
75020|NCT01056822|Primary|Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||Participants|||Number
74917|NCT01058863|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Day 37|Safety population of all randomized participants who received at least one dose of randomized study medication.||participants|||Number
74918|NCT01058863|Secondary|Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)|"Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values.~The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment||% predicted * hour||Standard Error|Mean
74919|NCT01058863|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment||L*hour||Standard Error|Mean
74920|NCT01058642|Primary|Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.|Baseline, Week 2 of Treatment Period 1 or 2|Zero participants were analyzed, and no data was collected for this measure. Due to lack of efficacy of ADL5747, the study was terminated early.|||||
74921|NCT01058356|Secondary|Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)||Up to14 days|||participants|||Number
74922|NCT01058356|Primary|Presence of AAD|AAD defined as: Watery stools more than 3 times per day for at least 2 days.|Up to 14 days|||participants|||Number
74923|NCT01058304|Secondary|Short Performance Physical Battery (SPPB)|"This battery of objective physical function tests examines participants’ balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12 weeks|All enrolled, randomized participants||units on a scale||95% Confidence Interval|Mean
74924|NCT01058304|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12-weeks, 24-weeks|All enrolled, randomized participants||units on a scale||95% Confidence Interval|Mean
74925|NCT01058265|Primary|Short Form 36 (SF-36) Mental Component Summary (MCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Mental Component Summary ranges from 0 to 100, and higher score indicates better mental health status. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months|||Scores on a scale||Inter-Quartile Range|Median
74926|NCT01058265|Primary|Short Form 36 (SF-36) Physical Component Summary (PCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Physical Component Summary ranges from 0 to 100, and higher score indicates better physical condition. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months|||Scores on a scale||Inter-Quartile Range|Median
74927|NCT01058070|Primary|To Monitor the Improvement of GERD Symptoms.|Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms|5 years|||percentage of participants|||Number
74928|NCT01058070|Primary|To Evaluate the Incidence of All Adverse Events at Various Time Points.||5 years|||participants|||Number
75021|NCT01056822|Primary|Number of Participants That Achieved One Dose Step Higher With Mycophenolic Acid (MPA) or Mycophenolate Mofetil (MMF), According to the Treatment Group Assigned at the End of the Study (Final Visit) Compared to Baseline Dose||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||study participants|||Number
74929|NCT01058005|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.|up to 108 Weeks|Participants who received at least 1 dose of study medication.||participants|||Number
74930|NCT01057901|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.||units on a scale||Standard Error|Least Squares Mean
74931|NCT01057901|Primary|Change From Baseline in the Number of Satisfying Sexual Events|"The change from baseline in the number of SSE’s as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).~Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question."|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.||SSEs/month||Standard Deviation|Mean
74932|NCT01057888|Primary|Well Child Care Status|Received recommended well child care visit|12 months|||participants|||Number
74933|NCT01057888|Primary|Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))||12 months|Individuals were randomized to one of 3 groups (letter reminders, telephone reminders or control). Individuals with a wrong/missing telephone number or a wrong address were excluded from the analyses. This left 1,396 in the letter reminder group, 1,423 in the telephone reminder group and 1,296 in the control group.||participants|||Number
74934|NCT01057810|Secondary|Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities|"NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria:~White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.~Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L.~Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN."|Randomization up to April 2015, approximately 57 months|All treated participants with on-study laboratory results||participants|||Number
74935|NCT01057810|Secondary|Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 1 of study therapy to last dose plus 70 days|All treated participants||participants|||Number
74936|NCT01057810|Secondary|Time to Pain Progression|"Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10).~Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism."|Randomization until pain progression, up to April 2015, approximately 57 months|All randomized participants||months||95% Confidence Interval|Median
75022|NCT01056822|Primary|Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||number of participants|||Number
74937|NCT01057810|Secondary|Time to Subsequent Non-hormonal Cytotoxic Therapy|For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).|Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months|All randomized participants who received subsequent non-hormonal cytotoxic therapy||months||95% Confidence Interval|Median
74938|NCT01057810|Secondary|Progression-Free Survival (PFS) Time|Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.|Randomization until disease progression, up to April 2015, approximately 57 months|All randomized participants||months||95% Confidence Interval|Median
74939|NCT01057810|Primary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.|Randomization until death from any cause, up to April 2015, approximately 57 months|All randomized participants||months||95% Confidence Interval|Median
74940|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)|GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.|Week 19|"FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||participants|||Number
74941|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)|GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.|Week 6|"SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||participants|||Number
74942|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
74943|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.||units on a scale||Standard Deviation|Mean
74944|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
74945|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.||units on a scale||Standard Deviation|Mean
74946|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Double-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||mm||Standard Deviation|Mean
74947|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Single-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.||mm||Standard Deviation|Mean
74948|NCT01057693|Secondary|Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
74949|NCT01057693|Secondary|Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time point.||units on a scale||Standard Deviation|Mean
74950|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Double-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
74951|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Single-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
74952|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Double-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
74953|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Single-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.||units on a scale||Standard Deviation|Mean
74954|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.||participants|||Number
74955|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.||participants|||Number
74956|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
74957|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here “n” signifies participants who were evaluable for specified time-point.||units on a scale||Standard Deviation|Mean
74958|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Double-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
74959|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Single-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
74960|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.||percentage of participants|||Number
74961|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.||percentage of participants|||Number
74962|NCT01057693|Secondary|Weekly Mean Pain Scores (Double-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
74963|NCT01057693|Secondary|Weekly Mean Pain Scores (Single-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.|Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time-point.||units on a scale||Standard Deviation|Mean
74964|NCT01057693|Secondary|Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 6 (SB Phase)|Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. “N” (number of participants analyzed): participants who were evaluable for this measure and “n”: participants who were evaluable for specified time-point. Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
74965|NCT01057693|Secondary|Time to Loss of Pain Response (Double-Blind Phase)|Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline up to Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.||days||95% Confidence Interval|Median
74966|NCT01057693|Primary|Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 19 (DB Phase)|Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
74967|NCT01057589|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant’s speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)|PQ Population: all randomized and treated participants with evaluable data at respective timepoint.||units on a scale||Standard Deviation|Mean
74968|NCT01057589|Secondary|Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy|EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 [no limitation], 2 [some limitation] or 3 [severe or complete limitation] in 5 dimensions [mobility, self-care, usual activities, pain/comfort and anxiety/depression]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).|Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.||units on a scale||Standard Deviation|Mean
74969|NCT01057589|Secondary|Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy|Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit).|Baseline, End of Triplet Combination Therapy (up to Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data for each category||units on a scale||Standard Deviation|Mean
74970|NCT01057589|Secondary|Percent of Participants With a Partial Response (PR) or a Complete Response (CR)|CR and PR based on RECIST Guidelines: CR is defined as the disappearance of all tumor lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or the complete disappearance of target lesions, with persistence (but not worsening) of one or more nontarget lesions and the appearance of no new lesions. PD is defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of first response to PD (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data; 6 participant's results were unknown.||percentage of participants||95% Confidence Interval|Number
74971|NCT01057589|Secondary|Overall Survival (OS)|OS defined as the time from the date of first dose of study drug to the date to death from any cause.|Baseline to date of death up to 18.7 months|PQ Population: all randomized and treated participants||months||95% Confidence Interval|Median
74972|NCT01057589|Primary|Progression Free Survival (PFS)|PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to date of PD or death up to 18.7 months|Protocol Qualified (PQ) Population: all randomized and treated participants||months||95% Confidence Interval|Median
74973|NCT01057433|Secondary|Adverse Events||24 Days||||||
74974|NCT01057433|Primary|Area Under the Curve From Time 0 to Tau (AUC 0-τ)|Area under the curve from start to elimination.|12 hours|||ng•h/mL||Standard Deviation|Mean
74975|NCT01057394|Primary|Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation|Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).|3 Months|Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation.||isolated pulmonary veins|||Number
74976|NCT01057277|Primary|Response||1 year|||participants|||Number
74977|NCT01057251|Primary|Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline (Week 0) to Visit 4 (Week 6)|||mm Hg||Standard Deviation|Mean
74978|NCT01057251|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)|||mm Hg||Standard Deviation|Mean
74979|NCT01057225|Secondary|Overall Survival (24 Month)|24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of patients||95% Confidence Interval|Number
74980|NCT01057225|Secondary|Overall Survival (12 Month)|12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of patients||95% Confidence Interval|Number
74981|NCT01057225|Secondary|Progession Free Survival (24 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark.|24 months|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of participants at 24 months||95% Confidence Interval|Number
74982|NCT01057225|Secondary|Progression Free Survival (12 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark.|12 months|All of the 64 participants that were eligible and began treatment were evaluated.||percentage of participants at 12 months||95% Confidence Interval|Number
74983|NCT01057225|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|From baseline to death|||months||95% Confidence Interval|Median
74984|NCT01057225|Secondary|Complete Response (Phase II)|In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.|Following the first 4 courses of treatment|||participants|||Number
74985|NCT01057225|Secondary|Stem Cell Collection and Engraftment (Phase II)|For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported.|Following the first 4 courses of treatment|Of the 64 patients that began protocol treatment, stem cell harvesting was attempted on 42 patients.||participants|||Number
74986|NCT01057225|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier|From baseline to end of active treatment|All enrolled patients who began treatment were evaluated for safety and response.||months||95% Confidence Interval|Number
74987|NCT01057225|Secondary|Progression-free Survival (Phase II)|"PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following:~• Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~• Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder"|From baseline to progression or death up to 3 years|All of the 64 participants that were eligible and began treatment were evaluated.||months||95% Confidence Interval|Number
74988|NCT01057225|Primary|Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)|"The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients.~A complete response is defined as:~Negative immunofixation of the serum and urine~If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio~< 5% plasma cells in bone marrow~Disappearance of any soft tissue plasmacytomas~A very good partial response is defined as:~Serum and urine M-component detectable by immunofixation but not on electrophoresis or~If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent~Urine M-component <100 mg per 24 hour"|Following the first 4 cycles of treatment (28 day cycles)|All enrolled patients who began treatment were evaluated for safety and response.||percentage of participants|||Number
74989|NCT01057225|Primary|Maximum Tolerated Dose (Phase I)|"To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone.~For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2.~We are reporting the number of DLTs"|From baseline to end of active treatment, up to 12 28-day cycles.|All patients registered to a dose escalation Phase I group were analyzed for this endpoint.||participants|||Number
74990|NCT01057121|Other Pre-specified|Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load|Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration.|Up to 30 days after completion of study treatment|The KSHV (HHV-8) assays were run, but the results were unreliable.|||||
75023|NCT01056718|Secondary|Quality of Life|"Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the best imaginable health state and 0 is the worst imaginable health state."|10 Weeks|||units on a scale||Standard Deviation|Mean
75024|NCT01056718|Secondary|Pulmonary Vein Peak Diastolic Velocity||10 Week|||cm/s||Standard Deviation|Mean
75025|NCT01056718|Secondary|Pulmonary Vein Peak Systolic Velocity||10 Week|||cm/s||Standard Deviation|Mean
75026|NCT01056718|Secondary|E/e' Ratio||10 Week|||Ratio||Standard Deviation|Mean
74991|NCT01057121|Secondary|Time to Response|"time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks.~Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Participants who had a complete or partial responses||weeks||Full Range|Median
74992|NCT01057121|Secondary|Time to Relapse|Percentage of participants who relapsed|Up to 30 days after completion of study treatment|Patients who relapsed|||||
74993|NCT01057121|Secondary|Time to Death|Percentage of patients who died|Up to 30 days after completion of study treatment|Study participants who died on study.||percentage of participants who died|||Number
74994|NCT01057121|Primary|Tumor Response Rate|"Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks.~Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Patients who were evaluable for response. To be evaluable for response, the patient had to complete at least one cycle of treatment.||percent of participants who responded||95% Confidence Interval|Number
74995|NCT01057121|Primary|Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)|Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.|28 days|Only patients in the phase I portion of the study were evaluated for this outcome measure.||mg per day of lenalidomide|||Number
74996|NCT01057017|Primary|Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab|To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3|every 3 weeks until patient comes off study (progressive disease), for up to 2 years|||participants|||Number
74997|NCT01056913|Secondary|Clinical Relevant Stenosis||six months||||||
74998|NCT01056913|Primary|Anastomotic Leakage||4-8 weeks|||participants|||Number
74999|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF)|Safety population per visit and per treatment group (missings not included)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.||mg|Participants|Standard Deviation|Mean
75000|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)|Safety population per visit and per treatment group|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.||mg|Participants|Standard Deviation|Mean
75001|NCT01056822|Secondary|Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group|Exposure to study drug (MPS). Data presented only for safety population on the study treatment arm (not applicable for MMF arm)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.||days|Participants|Standard Deviation|Mean
75002|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included||scores on a scale|Participants|Standard Deviation|Mean
75003|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
75027|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (a')||10 Week|||cm/s||Standard Deviation|Mean
75028|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (e')||10 Week|||cm/s||Standard Deviation|Mean
75029|NCT01056718|Secondary|Mitral Valve Deceleration Time||10 Week|||ms||Standard Deviation|Mean
75030|NCT01056718|Secondary|Mitral Valve E/A Ratio|mitral valve doppler E velocity to A velocity|10 Week|||Ratio||Standard Deviation|Mean
75031|NCT01056718|Secondary|Mitral Valve Inflow (A) Velocity||10 Week|||cm/s||Standard Deviation|Mean
75004|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75005|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75006|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75007|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75008|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75009|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75010|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75032|NCT01056718|Secondary|Mitral Valve Inflow (E) Velocity||10 Week|||cm/s||Standard Deviation|Mean
75033|NCT01056718|Secondary|LV Mass||10 week|||grams||Standard Deviation|Mean
75034|NCT01056718|Secondary|LV End Systolic Diameter||10 week|||cm||Standard Deviation|Mean
75035|NCT01056718|Secondary|LV End Diastolic Diameter||10 week|||cm||Standard Deviation|Mean
75036|NCT01056718|Secondary|Stress Cardiac Output||10 week|||L per minute||Standard Deviation|Mean
75037|NCT01056718|Secondary|Resting Cardiac Output||10 week|||L per minute||Standard Deviation|Mean
75038|NCT01056718|Secondary|Stress Stroke Volume||10 week|||ml||Standard Deviation|Mean
75011|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included||scores on a scale|Participants|Standard Deviation|Mean
75012|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75013|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)||scores on a scale|Participants|Standard Deviation|Mean
75014|NCT01056822|Secondary|Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.|The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
75015|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
75016|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Item Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included||scores on a scale|Participants|Standard Deviation|Mean
75017|NCT01056822|Secondary|Glomerular Filtration Rate (GFR) Using Abbreviated MDRD|Calculated GFR (MDRD formula): GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R where C is the serum concentration of creatinine [mg/dL], A is age [years], G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||mL/min/1.73m^2||Standard Deviation|Mean
75018|NCT01056822|Secondary|Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl)||Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).||ml/min|Participants|Standard Deviation|Mean
75019|NCT01056822|Primary|Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Per protocol (PP) population included all subjects from the ITT population who received medication throughout the study and did not have major protocol deviations and who participated in the study for a minimum of 210 days +/- 15 days||mg/day||Standard Deviation|Mean
75047|NCT01056718|Primary|Metabolic Equivalent (METS) Level|METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.|10 Weeks|||METS||Standard Deviation|Mean
75048|NCT01056718|Primary|Exercise Duration||10 Weeks|||Seconds||Standard Deviation|Mean
75049|NCT01056718|Primary|Resting Systolic BP||10 Weeks|||mm Hg||Standard Deviation|Mean
75050|NCT01056640|Primary|Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease.||12 months|This study utilized an intent-to-treat method. Everyone randomized to study was included in the analysis||hospitalizations||Standard Deviation|Mean
75051|NCT01056601|Secondary|Duration of Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).|Up to 1 Year|||Weeks|||Number
75052|NCT01056601|Secondary|Number of Participants by Tumor Response|Number of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|Up to 1 Year|||Participants|||Number
75053|NCT01056601|Primary|Progression-Free Survival|Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|Up to 1 Year|||Months||95% Confidence Interval|Median
75054|NCT01056523|Secondary|Blast Response|Blast response was defined as a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days.|2-3 years|Only patients treated for 28 days or more were evaluable for response.||Participants|||Count of Participants
75055|NCT01056523|Secondary|Partial Response|Partial response was defined as 5 to 25% blasts in the bone marrow and Hgb >100g/L, platelets >100,000/ul and neutrophils >1000/ul.|2-3 years|Only patients treated for 28 days or more were assessed for response.||Participants|||Count of Participants
75056|NCT01056523|Secondary|Complete Response Rate|Defined as <5% blasts in the bone marrow and a hgb 100 g/L, platelets 100,000/uL, neutrophils 1000/uL.|2-3 years|Only patients treated for at least 28 days were evaluable for response.||Participants|||Count of Participants
75057|NCT01056523|Secondary|Overall Response Rate|Overall response rate comprises complete response (<5% blasts in the bone marrow, and in the peripheral blood Hgb more than or equal to 100 g/L, platelets more than or equal to 100x10-9/L, and neutrophils more than or equal to 1x10-9/L), partial response (5 to 25% blasts in the bone marrow and same peripheral blood parameters) and blast response (a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days).|2-3 years|Only patients treated for 28 days or more were evaluable for response.||Participants|||Count of Participants
75058|NCT01056523|Primary|Recommended Phase II Dose (RP2D) of Ribavirin When Given in Combination With Low-dose Ara-C|This 3+3 designed aimed to determine recommended phase II dose (RP2D) based on pharmacokinetics (PK) and maximum tolerated dose (MTD). For the dose to be selected, a target steady state level of ribavirin 20 uM was needed for all patients and no more than 1 of 6 patients could have had dose limiting toxicity at that dose.|56 days|||mg|||Number
75059|NCT01056510|Secondary|Proportion of Malignant B-cells in Normal B-cells Among Participants With a Positive Outcome for MRD in the First-Line Subpopulation|The proportion of malignant B-cells in normal B-cells was quantitatively determined, and was calculated as the number of malignant B-cells divided by the number of normal B-cells observed.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with a positive outcome for MRD were included in the analysis.||proportion||Standard Deviation|Mean
75060|NCT01056510|Secondary|Number of Participants With Positive and Negative Outcome for MRD in the First-Line Subpopulation|Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001, and positive MRD was defined as a proportion of malignant B-cells in normal B-cells >/= 0.0001.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with available MRD data (MRD-evaluable participants) were included in the analysis.||participants|||Number
75061|NCT01056510|Secondary|Percentage of Participants Achieving Molecular Response in the First-Line Subpopulation|Molecular response was defined as negative minimal residual disease (MRD) during study treatment or within 4 months after the end of treatment. Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001. The percentage of participants achieving molecular response was calculated as the number of participants with negative MRD divided by the number of participants analyzed.|Up to 4 months after the last treatment cycle (up to 40 weeks)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR during study treatment or within 4 months after the end of treatment were considered in the analysis.||percentage of participants|||Number
75062|NCT01056510|Secondary|Overall Survival (OS) in the First-Line Subpopulation|OS was defined as the time from recorded diagnosis to death from any cause. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
75080|NCT01056484|Primary|Percent Days Abstinent From Alcohol|Measures percent days abstinent from alcohol|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.||percent of days abstinent from alcohol||Standard Deviation|Mean
75063|NCT01056510|Secondary|Percentage of Participants Experiencing Death in the First-Line Subpopulation|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
75064|NCT01056510|Secondary|Duration of Response in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nPR to the first documentation of PD or death, whichever occurred first. Duration of response was calculated in months as [first event date minus first assessment date of CR/CRi/PR/nPR plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.||months||95% Confidence Interval|Median
75065|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR, CRi, PR, or nPR Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.||percentage of participants|||Number
75066|NCT01056510|Secondary|Time to Next Leukemia Treatment (TNLT) in the First-Line Subpopulation|TNLT was defined as the time from the first dose of trial treatment to the first documentation of any new leukemia treatment. TNLT was calculated in months as [first new treatment date minus first dose date plus 1] divided by 30.44.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
75067|NCT01056510|Secondary|Percentage of Participants With Documented Intake of New Leukemia Therapy in the First-Line Subpopulation|The percentage of participants with documented intake of new (post-trial) leukemia therapy was calculated as the number of participants with new therapy divided by the number of participants analyzed, multiplied by 100.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
75068|NCT01056510|Secondary|Event-Free Survival (EFS) in the First-Line Subpopulation|The criteria for PD and SD are identified in previous outcome measure(s). EFS was defined as the time from the first dose of trial treatment to the first documentation of PD, the beginning of new treatment for any hematologic malignancy, or death from any cause. Those with SD were considered event-free. EFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
75069|NCT01056510|Secondary|Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD, intake of new (post-trial) leukemia therapy, or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
75070|NCT01056510|Secondary|Disease-Free Survival (DFS) in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). DFS was defined as the time from the first assessment of CR or CRi to the first documentation of PD or death, whichever occurred first. DFS was calculated in months as [first event date minus first assessment date of CR/CRi plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.||months||95% Confidence Interval|Median
75071|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.||percentage of participants|||Number
75072|NCT01056510|Secondary|Progression-Free Survival (PFS) in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). PFS was defined as the time from the first dose of trial treatment to the first documentation of PD or death, whichever occurred first. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||months||95% Confidence Interval|Median
75073|NCT01056510|Secondary|Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
75074|NCT01056510|Secondary|Percentage of Participants by Disease Response Category in the First-Line Subpopulation|The criteria for CR, CRi, PR, and nPR are identified in previous outcome measure(s). PD was defined by at least one of the following: the presence of lymphadenopathy; an increase in the previously noted enlargement of the liver or spleen by >/= 50% or the de novo appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by >/= 50% with >/= 5000 B-cells per microliter (B-cells/mcL); transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Participants not achieving a CR or PR, and who did not exhibit PD, were considered to have stable disease (SD). The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed. The rows below are labeled first by the level of response at the end of 6 cycles (C6), then by level of response at the confirmation assessment.|After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks)|ITT Population (First-Line Subpopulation)||percentage of participants|||Number
75075|NCT01056510|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation|The criteria for CR are identified in previous outcome measure(s). Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection|ITT Population (First-Line Subpopulation)||percentage of participants||95% Confidence Interval|Number
75076|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (Second-Line Subpopulation): A subset of participants requiring a second-line regimen for CLL.||percentage of participants|||Number
75077|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population||percentage of participants|||Number
75078|NCT01056510|Primary|Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (<) 4 times 10^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (>/=) 1.5 times 10^9 cells/L, platelets greater than (>) 100 times 10^9 cells/L, and hemoglobin > 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with < 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (First-Line Subpopulation): A subset of participants requiring a first-line regimen for CLL.||percentage of participants|||Number
75079|NCT01056484|Primary|Time to Relapse (Resumption of Drinking)|Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.|26 weeks|Only 105 participants provided data for this measure at 26-week follow up; due to participants either: declining participation for the visit, being unable to reach within the 26-week follow up time, or withdrawing from the study before 26-week follow up. Of the 105, 3 meditation/0 controls met criteria for having relapsed during this time frame.||number of days to relapse||Standard Deviation|Mean
75081|NCT01056484|Secondary|Subject Treatment Adherence|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions.|8 weeks|"Of 64 enrolled participants, one withdrew prior to the first intervention session. This participant's data was included in the baseline data analyses; this participant's meditation intervention attendance was counted as 0."||Percentage of meditation participants|||Number
75082|NCT01056484|Secondary|Subject Treatment Satisfaction|Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied').|8 weeks|48 participants provided data for this outcome measure at an 8-week follow up visit, and their responses were analyzed.||points||Standard Deviation|Mean
75083|NCT01056484|Secondary|Drinker Inventory of Consequences|Severity of drinking related negative consequences as measured by the Drinker Inventory of Consequences (DrInC-2R). This inventory consists of 50 items rated on a scale of 0 to 3, with '0' indicating a given consequence did not happen, '1' indicating it almost happened, '2' indicating it did happen, and '3' indicating it happened more than once. The sum of all ratings (minus the 5 control questions) indicates the 'total score', with higher scores corresponding to more drinking related consequences. The 'total score' can range from 0 (did not happen) to 135 (happened all the time).|26 weeks|Only 98 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.||Scores on a scale||Standard Deviation|Mean
75084|NCT01056484|Primary|Percent Heavy Drinking Days|Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period.|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.||percentage of heavy drinking days||Standard Deviation|Mean
75085|NCT01056341|Secondary|Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.|Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits|6 months||||||
75086|NCT01056341|Primary|Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.||6 months|After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site.||percentage of participants|||Number
75087|NCT01056341|Primary|Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.||6 months|Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm.||percentage of participants|||Number
75088|NCT01056328|Secondary|Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs|Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)|12 months|||participants|||Number
75089|NCT01056328|Secondary|Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period||12 months|||participants|||Number
75090|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite.||12 months|||participants|||Number
75091|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite|Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.|7 days|||participants|||Number
75092|NCT01056328|Primary|Confirmation of Entrance Block in the Pulmonary Veins||20 minutes after initial isolation|||participants|||Number
75093|NCT01056315|Secondary|Assessment of Rescue Medication Usage During the 4-week Titration.||4-week titration phase||||||
75094|NCT01056315|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy.||Baseline to time to treatment discontinuation||||||
75095|NCT01056315|Secondary|Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
75096|NCT01056315|Secondary|Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
75097|NCT01056315|Secondary|EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
75098|NCT01056315|Secondary|Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.||||||
75099|NCT01056315|Secondary|Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).||Day 29, Day 71 and Day 113.||||||
75100|NCT01056315|Secondary|Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)||Baseline, weekly mean||||||
75101|NCT01056315|Secondary|Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).||Baseline, weekly mean||||||
75102|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.||Baseline, weekly mean||||||
75103|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).||Baseline; weekly mean||||||
75104|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.||Baseline; daily scores over each week of maintenance||||||
75108|NCT01056289|Secondary|Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms|Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population||percentage of participants|||Number
75109|NCT01056289|Secondary|Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase|Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population (Double-blind phase): all participants who received at least 1 dose of study treatment and were randomized into the Double-blind treatment phase.||percentage of participants|||Number
75110|NCT01056289|Primary|Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase|Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2).|Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)|Full Analysis Set (FAS): all randomized participants who had at least 1 postrandomization DESS record. Mean was adjusted for baseline DESS score and study center.||scores on a scale||Standard Error|Mean
75111|NCT01056263|Primary|Overall Survival (OS)|Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline until death or up to Year 5|Full analysis set included all participants who received at least 1 dose of axitinib (AG-013736).||Days||95% Confidence Interval|Median
75112|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Control Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat||square centimeters||Standard Deviation|Mean
75113|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Santyl Treatment Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat||square centimeters||Standard Deviation|Mean
75114|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up||baseline and 84 days|Intent-to-Treat population||percentage of baseline wound area||Standard Error|Mean
75115|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at End of Treatment||baseline and 28 days|Intent-to-Treat population||percentage of baseline wound area||Standard Error|Mean
75116|NCT01056198|Primary|Bates-Jensen Wound Assessment Score - Modified (BWAT-m)|The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).|baseline and 28 days|Intent-to-Treat population||units on a scale||Standard Deviation|Mean
75117|NCT01056107|Secondary|Stool Consistency Post Treatment|"The subjects rated their stool consistency using the 7-point Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea. The Bristol stool form was part of the bowel pattern diary, which was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study."|34 days (Visit 6)|Intent-to-treat||units on a scale||Standard Error|Mean
75118|NCT01056107|Secondary|Stool Frequency|Stool frequency was self reported in a Bowel Pattern Diary. The bowel pattern diary was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.|screening visit (Visit 1), 34 days (Visit 6)|Intent-to-treat||Stools/day||Standard Error|Mean
75119|NCT01056107|Secondary|Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours (Visit 4 = Day 2)|Intent-to-treat||units on a scale||Standard Error|Mean
75120|NCT01056107|Secondary|Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy|Ascending colon emptying half-time will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours (Visit 4 = Day 2)|Intent-to-treat||hours||Standard Error|Mean
75121|NCT01056107|Secondary|Colonic Filling at 6 h Measured by Scintigraphy|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours (Visit 2 = Day 0)|Intent-to-treat||percentage of meal||Standard Error|Mean
75184|NCT01055171|Primary|Test Session Craving Scores (Session 2)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during test session (Session 2)|||units on a scale||Standard Error|Mean
75122|NCT01056107|Secondary|Colonic Geometric Center at 4 h Measured by Scintigraphy|"The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. (Note: when there is no radio isotope in the colon (e.g., at 4 hours) the geometric center values are recorded as zero, thus the mean values can be less than one.)"|4 hours (Visit 2 = Day 0)|Intent-to-treat||units on a scale||Standard Error|Mean
75123|NCT01056107|Secondary|Gastric Residual at 2 and 4 Hours Measured by Scintigraphy|The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).|2 hours, 4 hours (Visit 2 = Day 0)|Intent-to-treat||proportion of isotope in the stomach||Standard Error|Mean
75124|NCT01056107|Primary|Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)|Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.|approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)|Intent-to-treat||minutes||Standard Error|Mean
75125|NCT01056107|Primary|Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)|"A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the fasting volume and 2 postprandial volumes were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation)."|approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)|Intent-to-treat||mL||Standard Error|Mean
75126|NCT01056107|Primary|Colonic Transit, Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours (Visit 3 = Day 1)|Intent-to-treat||units on a scale||Standard Error|Mean
75127|NCT01056016|Primary|Physician ADHD Practice Behavior|Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response|Baseline and 6 months|Patient chart reviews were conducted with 174 patients in the ADHD Collaborative Intervention group and 64 patients in the Wait-list control group||percentage of patients||Standard Deviation|Mean
75128|NCT01055886|Other Pre-specified|Diary Ratings of Cravings|"Participants provided (through ecological momentary assessment) ratings of their smoking craving. This outcome reflects differences between ad lib (or typical) smoking craving compared to smoking craving reported during the pre-quit period. Craving was reported from a single item Please indicate your desire/craving to smoke, and answers were provided in a 5-point Likert scale where 1=no craving and 5=severe craving. Higher scores are presumed to be worse because they indicate increased craving, which is likely to lead to non-abstinence."|During pre-quit period; two weeks|61 participants provided this EMA data during the pre-quit period.||units on a scale||Standard Error|Mean
75129|NCT01055886|Secondary|Abstinence as Measured by Exhaled Carbon Monoxide (CO)|This outcome reflects the number of participants whose exhaled carbon monoxide (CO; a measure of smoking) indicated abstinence (i.e., 6 parts per million or less) at Session 12, which occurred six weeks post-quit.|Session 12, 6 weeks post-quit|Data was available on 30 participants who attended Session 12.||participants|||Number
75130|NCT01055886|Primary|Participants Self-reporting Abstinence During 6 Weeks Post Quit|In the 6 week post-quit period, participants completed ecological momentary assessment (EMA), or diary, ratings of their smoking behavior. This outcome reflects the number of participants who reported not relapsing (i.e., smoking 7 days in a row) during the 6 weeks post-quit.|6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12|37 participants completed the ecological momentary assessment (EMA; diary) ratings during the post-quit period.||participants|||Number
75131|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.||ng*hr/mL||Standard Deviation|Mean
75132|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.||ng/mL||Standard Deviation|Mean
75133|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.||ng*h/mL||Standard Deviation|Mean
75134|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.||ng/mL||Standard Deviation|Mean
75135|NCT01055782|Secondary|Perception of Pain|VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale|After endoscopy (within 10mins) and 1 day after endoscopy|||Scores on a scale 0-10||Standard Deviation|Mean
75136|NCT01055782|Primary|Completed Colonoscopy||immediately after colonoscopy|Choosen by randomization.||participants|||Number
75137|NCT01055769|Secondary|Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||hours||Standard Deviation|Mean
75138|NCT01055769|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The time of the first occurrence of peak concentration observed directly from data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||hours||Full Range|Median
75139|NCT01055769|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||mcg*h/mL||Standard Deviation|Mean
75140|NCT01055769|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
75141|NCT01055769|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.||microgram*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
75142|NCT01055704|Secondary|Stool Consistency as Reported From the Bristol Stool Scale|"Bristol Stool Scale a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5–7 tending towards diarrhea."|Daily|||Units on a scale||Standard Error|Mean
75143|NCT01055704|Secondary|Stool Frequency|Stool frequency was self reported in a daily bowel pattern diary for 13 days.|daily|||Stools||Standard Error|Mean
75144|NCT01055704|Secondary|Colonic Filling at 6 Hours|Percent of solids reaching the colon at 6 hours|6 hours|||Percentage||Standard Error|Mean
75145|NCT01055704|Secondary|Colonic Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours|||Units on a scale||Standard Error|Mean
75146|NCT01055704|Secondary|Colonic Geometric Center at 4 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|4 hours|||Units on a scale||Standard Error|Mean
75147|NCT01055704|Secondary|T1/2 of Gastric Emptying of Solid||4 hours|||Minutes||Standard Error|Mean
75148|NCT01055704|Secondary|T1/2 of Ascending Colon Emptying||24 hours|||hours||Standard Error|Mean
75149|NCT01055704|Primary|Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours|||Units on a scale||Standard Error|Mean
76595|NCT01036321|Secondary|Biomarkers of Disease Progression - Total Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||ng/dL||Full Range|Median
75150|NCT01055639|Secondary|Pittsburgh Sleep Quality Index|The 19-item Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is the most commonly used measure of self-rated sleep quality, with good reliability (alpha = .83, test-retest = .85) and validity (kappa = 0.75) for distinguishing good and poor sleepers. A survey recently conducted by the IMMPACT group indicated that sleep is one of the domains most important to patients with chronic pain (Turk et al., 2008), and the PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients (Cole et al., 2007). Scores range from 0 (good sleep) to 42 (poor sleep).|8 weeks|||units on a scale||Standard Deviation|Mean
75151|NCT01055639|Secondary|PTSD Checklist|The 17-item PTSD Checklist (Weathers et al., 1994) will be used to assess PTSD symptoms. In combat veterans, this questionnaire has high test-retest reliability (0.96) and validity as indicated by a kappa of 0.64 for diagnosis of PTSD using the SCID (Weathers et al., 1993). Scores range from 17 (low PTSD) to 85 (high PTSD).|8 weeks|||units on a scale||Standard Deviation|Mean
75152|NCT01055639|Secondary|Pain Anxiety Symptom Scale - 20|Anxiety will be assessed with the 20-item Pain Anxiety Symptoms Scale-Short Form (PASS-20; McCracken & Dhingra, 2002). Pain anxiety captures fears patients associate with their symptoms, which are typically associated with the belief that their pain signals harm. High levels of pain anxiety compromise patient’s activity levels, participation in rehabilitation, and performance on functional tests. The instrument is a valid and reliable measure of anxiety symptoms in pain populations (McCracken et al., 1996; Roelofs et al., 2004). The PASS-20 items are scored on a 6-point Likert scale and assess cognitive, escape/avoidance, fear, and physiological anxiety dimensions. Internal consistency is high and correlation between the short and long form is excellent (alpha=.81; r=.97). This measure has been recommended by the VA and demonstrated sensitivity to treatment in the pilot sample (National VA Pain Outcomes Working Group, 2003). Scores range from 0 (least anxiety) to 100 (most anxiety).|8 weeks|||units on a scale||Standard Deviation|Mean
75153|NCT01055639|Secondary|Patient Health Questionnaire-9|The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the scoring severity index. Scores range from 0 (lowest level of depressive symptoms) to 27 (highest level of depressive symptoms).|8 weeks|||units on a scale||Standard Deviation|Mean
75154|NCT01055639|Secondary|SF-12 PCS|Physical health-related quality of life will be measured using the Physical Component Summary score of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks|||units on a scale||Standard Deviation|Mean
75155|NCT01055639|Secondary|SF-12 MCS|6-item self-report measure of mental health-related quality of life. Subscale of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks|||units on a scale||Standard Deviation|Mean
75156|NCT01055639|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|The West Haven-Yale Multidimensional Pain Inventory (MPI; Kerns et al., 1985) contains 52 items forming 12 subscales. For this study, we used four subscales assessing various types of activities. Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items). The MPI has been used extensively in outcome research with heterogeneous samples of chronic pain patients, including veterans, and has demonstrated sensitivity to treatment change (Altmaier et al., 1992; Mikail et al., 1993). Individual items are rated on a 7-point Likert scale from 0-6, and subscales are scored by averaging items together. Therefore, the score for Part III, General Activity, is composed of an average of the 18 items in the Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items) subscales. The final score ranges from 0 (lowest level of activity) to 6 (highest level of activity).|8 weeks|||units on a scale||Standard Deviation|Mean
75157|NCT01055639|Secondary|Brief Pain Inventory-severity Subscale|The Brief Pain Inventory Short Form (BPI; Cleeland & Ryan, 1994) includes a 4-item pain severity subscale measuring the level of pain over the past week on average, at its worst, at its least, and currently. This measure is recommended by the IMMPACT group as a pain assessment tool (Dworkin et al., 2005). Scores range from 0 (least pain severity) to 10 (most pain severity).|8 weeks|||units on a scale||Standard Deviation|Mean
75158|NCT01055639|Primary|Brief Pain Inventory-interference Subscale|The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland & Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).|8 weeks|||units on a scale||Standard Deviation|Mean
75159|NCT01055613|Primary|Distance Visual Acuity (LogMAR)|Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.|Up to 3 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR|Participants|Standard Deviation|Mean
75160|NCT01055613|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.|3 months|The analysis population consists of all subjects that were dispensed a solution during the course of the study.||Subjects Eyes|Participants||Number
75161|NCT01055457|Primary|Distance Visual Acuity (LogMAR)|Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.|Up to 3 Months Post Lens Wear|All subjects that completed the study.||LogMAR|Subjects Eyes|Standard Deviation|Mean
75162|NCT01055457|Primary|Slit Lamp Findings (SLF)|Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.|Up to 3 months Post Lens Wear|All subjects that completed the study.||eyes (2 per subject)|Subject eyes||Number
75163|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day|Skin assessments performed after 4 hours of wear, participants discontinued wrap wear for remainder of day (4 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Erythema grading scale: 7 point scale ranging from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda and follicular response.|Baseline to Day 6|Safety Population||Percentage of participants|||Number
75164|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day|Skin assessments performed prior to heatwrap application; participant discontinued wrap wear for day (8 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Outcome included those who discontinued wrap wear by 4 hours on same day. Erythema grading scale: 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response.|Baseline to Day 6|Safety Population||Percentage of participants|||Number
75165|NCT01055262|Secondary|Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation|Participants discontinued study due to adverse event (AE) if erythema ≥ 2.0, pain upon touch associated with non-zero erythema score or elevated response on the morning of Day X+1. Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Baseline to Day 6|Safety population; N = participants with a non-zero erythema score or elevated response leading to study discontinuation.||Days||Standard Deviation|Mean
75166|NCT01055262|Secondary|Time to First Report of Non-zero Erythema Score or Elevated Response|Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Baseline to Day 6|Safety population; N = participants with any application site finding||Days||Standard Deviation|Mean
75167|NCT01055262|Secondary|Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)|Events associated with Day X wear (eg, Day 5) assessed on the morning of Day X+1 (eg, Day 6). Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Day 2 to Day 6|Safety Population||Percentage of participants||95% Confidence Interval|Number
75168|NCT01055262|Secondary|Time to First Significant Skin Event|Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Baseline to Day 6|Safety population; Number of participants analyzed (N) = number of participants with significant skin event.||Days||Standard Deviation|Mean
75169|NCT01055262|Secondary|Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)|Events associated with Day X wear (eg, Day 4) assessed on the morning of Day X+1 (eg, Day 5). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Day 2 to Day 5|Safety population||Percentage of participants||95% Confidence Interval|Number
75170|NCT01055262|Primary|Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)|Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter [cm] diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Day 2 to Day 6|Safety population: participants who wore the product at least once during the study||Percentage of participants||95% Confidence Interval|Number
75171|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
75172|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
75173|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
75174|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
75175|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.||fractures|||Number
75176|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 and December 31, 2008|Type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.||fractures|||Number
75177|NCT01055197|Secondary|Evaluation of the Percentage of the Planned Radiotherapy Dose to Each Site||From start to end of radiation therapy.||||||
75178|NCT01055197|Secondary|Comparison of Time to First Failure||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.||||||
75179|NCT01055197|Secondary|Patterns of Failure||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.||||||
75180|NCT01055197|Secondary|Comparison of Treatment-related Adverse Events||From start of treatment to end of follow-up.||||||
75181|NCT01055197|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
75182|NCT01055184|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|day 0 to day 7 post vaccination|||participants|||Number
75185|NCT01055171|Primary|Test Session Distress Scores (Session 2)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during test session (Session 2)|||units on a scale||Standard Error|Mean
75186|NCT01055171|Primary|Retrieval Session Craving Scores (Session 1)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during retrieval session (Session 1)|||units on a scale||Standard Error|Mean
75187|NCT01055171|Primary|Retrieval Session Distress Scores (Session 1)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during retrieval session (Session 1)|||units on a scale||Standard Error|Mean
75188|NCT01055132|Primary|Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||units on a scale||Standard Deviation|Mean
75189|NCT01055132|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||units on a scale||Standard Deviation|Mean
75190|NCT01055132|Primary|Binocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||LogMAR||Standard Deviation|Mean
75191|NCT01055132|Primary|Monocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.||logMAR||Standard Deviation|Mean
75192|NCT01054976|Secondary|Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)|The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning.|Baseline, Week 12|Intention-to-Treat analysis set.||scores on a scale||Standard Deviation|Mean
75193|NCT01054976|Secondary|Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)|"DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on not applicable (x) which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function"|Baseline, Week 12|Intention-to-Treat analysis set.||scores on a scale||Standard Deviation|Mean
75194|NCT01054976|Secondary|Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)|The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening.|Baseline, Week 12|Intention-to-Treat analysis set.||scores on a scale||Standard Deviation|Mean
75195|NCT01054976|Primary|Change From Baseline in Choice Reaction Time|The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.|Baseline, Week 12|Per-protocol (PP) analysis set.||seconds||Standard Deviation|Mean
75782|NCT01048424|Secondary|Change in Incontinence- or Bladder-specific Quality of Life|Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
75197|NCT01054911|Secondary|Alteration in Diffusion and Vascularity Kinetics|The Response Evaluation Criteria in Solid Tumors (RECIST) criteria may be insensitive in assessing GIST so the Choi criteria will be used. The Choi criteria accounts for morphologic tumor changes and biologic alterations. Diffusion-weighted magnetic resonance imaging (MRI) and dynamic contrast magnetic resonance will be used to find the vascular permeability and apparent diffusion coefficient 9ACD) at baseline, Week 2 and Week 6. Weeks 2 and 6 values will be compared to the baseline values using paired t tests.|MRI at baseline, Week 2 and Week 6|Data were not collected|||||
75198|NCT01054911|Secondary|Measurable Disease Response Rate|Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed|FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12|Data were not collected.|||||
75199|NCT01054911|Primary|Number of Participants With Adverse Events||6 months|||participants|||Number
75200|NCT01054885|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.||Minutes||Full Range|Median
75201|NCT01054885|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.||Liters||Standard Error|Least Squares Mean
75202|NCT01054885|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an ‘Other’ endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Scores on a scale||Standard Error|Least Squares Mean
75203|NCT01054885|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
75215|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
75235|NCT01054729|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 4|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug||percentage of participants|||Number
75204|NCT01054885|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
75205|NCT01054846|Secondary|Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners|Number of injuries by helmet wearing status as reported|5 months|Analysis population includes all participants that owned a helmet and available data for this assessment||Injuries|||Number
75206|NCT01054846|Primary|Percentage of Participants Wearing Helmet||Baseline (Survey 1) and 5 months (Survey 2)|Analysis reflect population that owned the helmet during each survey||Percentage of Participants|||Number
75207|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator|Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.||participants|||Number
75208|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant|Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.||participants|||Number
75209|NCT01054820|Secondary|Mean Change From Baseline to EOT in Beck Depression Inventory® Il|The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and >40=extreme depression.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; End-of-Treatment score was the most recent non-missing value.||scores on a scale||Standard Deviation|Mean
75210|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator|Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population||participants|||Number
75211|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant|Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population||participants|||Number
75212|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation.||percent||Standard Deviation|Mean
75213|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
75214|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
75232|NCT01054729|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment|SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).|Post-treatment Weeks 12 and 24|Safety Analysis Set||percentage of participants|||Number
75216|NCT01054820|Secondary|Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.||participants|||Number
75217|NCT01054820|Primary|Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.||scores on a scale||Standard Deviation|Mean
75218|NCT01054742|Primary|Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study|A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.|From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1, Part 2 of the study, and who consented to retreatment.||participants|||Number
75219|NCT01054729|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir||Baseline to Week 4|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.||percentage of participants|||Number
75220|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27|The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
75221|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0|The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
75222|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 27|The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
75223|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 0|The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
75224|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27|The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
75225|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0|The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
75226|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 27|The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
75227|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 0|The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
75228|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27|"The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).~AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
75229|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0|"The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).~AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||h*ng/mL||Standard Deviation|Mean
75230|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27|The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
75231|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0|"The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.~Cmax is defined as the maximum concentration of drug."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.||ng/mL||Standard Deviation|Mean
75244|NCT01054625|Primary|Maximum Plasma Concentration of Zalutumumab After Fourth Infusion|PK samples are taken: pre and post infusion on days 0, 14, 21 and 28 plus at +3 and +12 hours on days 0 and 28. A single PK sample is taken on days between these treatments and 8 more are taken over 3 weeks after treatment on day 28.|Pre and post infusion after weekly administration of zalutumumab during 28 days|||mg/L||Geometric Coefficient of Variation|Geometric Mean
75245|NCT01054586|Other Pre-specified|Median Bilirubin Level at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||milligrams (mg)/deciliter (dl)||Full Range|Median
75246|NCT01054586|Other Pre-specified|Median Blood Platelet Count at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||10^9/liter||Full Range|Median
75247|NCT01054586|Secondary|Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures|Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population.|Incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||incidence rate|||Number
75248|NCT01054586|Secondary|Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only|Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available)|The incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||participants|||Number
75249|NCT01054586|Secondary|Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen|Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||participants|||Number
75250|NCT01054586|Secondary|Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r|Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||participants|||Number
75251|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events|Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available).|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75252|NCT01054586|Secondary|Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only|Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75253|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75254|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75255|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75256|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75257|NCT01054586|Other Pre-specified|Median ALT and AST Scores at Baseline|Participants characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||IU/L (International Units per Liter)||Full Range|Median
75258|NCT01054586|Other Pre-specified|Median Model of End-stage Liver Disease (MELD) Score at Baseline|MELD is a scoring system for assessing the severity of chronic liver disease and is used to predict participant survival. It is calculated using biochemical values as follows: MELD = (0.957 x Log[Creatinine]) + (0.378 x Log[Bilirubin]) + (1.120 x Log[INR]) + 0.6431. INR = International Normalized Ratio for prothrombin time. MELD scores range between 0 and 40, with 40 being the most severe, i.e., 100% mortality. In interpreting the MELD score in hospitalized participants, the 3-month mortality is: score >=40, 100% mortality; 30–39, 83% mortality; 20–29, 76% mortality; 10–19, 27% mortality.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe. MELD scores are not available for the “FPV 700 mg BID/RTV 100 mg QD” group due to missing data.||MELD score||Full Range|Median
75447|NCT01051856|Secondary|Severity of the Pancreatic Fistula Leaks|Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.|90 days post operative|||Pancreatic fistula leaks|||Number
75259|NCT01054586|Other Pre-specified|Median FIB (a Model of End-stage Liver Disease) Score at Baseline|The FIB-4 score is an index that combines biochemical values (platelets, ALT, AST) and age to determine the degree of hepatic fibrosis. FIB-4 = (Age x AST)/(Platelet counts x ALT1/2). The FIB-4 score ranges between values of 0 to 13. A score of <1.45 indicates no/moderate fibrosis (F0-F1-F2-F3 in the ISHAK classification of fibrosis), whereas a score >3.25 is indicative of extensive fibrosis or cirrhosis (F4-F5-F6). The ISHAK classification of fibrosis is a commonly used scoring system that stages fibrosis from 0-6 (1-2, portal fibrotic expansion; 3-4, bridging fibrosis; 5-6, cirrhosis).|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||FIB Score||Full Range|Median
75260|NCT01054586|Other Pre-specified|Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline|The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. It is calculated as follows: APRI score = ([AST level/Upper Limit Normal]/Platelet counts) x 100. AST = Aspartate aminotransferase. In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||APRI Score||Full Range|Median
75261|NCT01054586|Other Pre-specified|Cluster of Differentiation (CD4) Count at Baseline|Participant characteristics at baseline according to treatment group. CD4 count is a measurement of how many functional CD4 T-cells are circulating in the blood. The lower the absolute CD4 count, the weaker the immune system.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||cells/microliter (μl)||Full Range|Median
75262|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75263|NCT01054586|Other Pre-specified|Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline|Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||years||Full Range|Median
75264|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75265|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75266|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75267|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75268|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75269|NCT01054586|Primary|Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe||events|||Number
75270|NCT01054573|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||log 10 IU/ml||Full Range|Median
75271|NCT01054573|Secondary|Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time|The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Log 10 IU/mL||Full Range|Median
75272|NCT01054573|Secondary|Percentage of Participants Who Relapsed During Follow-Up|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)|The analysis was performed on the full analysis (FA) set, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.||Percentage of participants|||Number
75315|NCT01054170|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Total Score||Standard Error|Least Squares Mean
75273|NCT01054573|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase.|Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
75274|NCT01054573|Secondary|Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).|Weeks 4 and 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
75275|NCT01054573|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
75276|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36|The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL.|Week 12 or Weeks 24 or 36|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
75277|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8|The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL.|Week 4, Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
75278|NCT01054573|Secondary|The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.|Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants with response|||Number
75279|NCT01054573|Primary|The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)|The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.|End of trial (24 weeks after last dose, administerd at 48 weeks)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.||Percentage of participants with response|||Number
75280|NCT01054560|Primary|Procedure-related Serious Adverse Events (SAEs)|Incidence of study procedure-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat||percentage of subjects|||Number
75281|NCT01054560|Primary|Study Device-related Serious Adverse Events (SAEs)|Incidence of study device-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat||percentage of subjects|||Number
75282|NCT01054560|Secondary|Non-fatal Stroke-related Morbidity|Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events|90 Day|Intent-to-treat||percentage of subjects|||Number
75283|NCT01054560|Secondary|Symptomatic Intracranial Hemorrhage|Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.|24 hours|Intent to treat||Percentage of subjects|||Number
75284|NCT01054560|Secondary|Mortality|Rate of Mortality|90 Days follow-up|Intent-to-treat||Percentage of subjects|||Number
75285|NCT01054560|Secondary|Good Neurological Outcome 90 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|90 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Percent of subjects|||Number
75286|NCT01054560|Secondary|Good Neurological Outcome at 30 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|30 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.||Percent of subjects|||Number
75287|NCT01054560|Secondary|Time to Initial Recanalization|Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow|post treatment|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size||minutes||Standard Deviation|Mean
75288|NCT01054560|Primary|Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage|"Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes.~Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy.~TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)"|Immediately post treatment|Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.||Percent of Subjects|||Number
75289|NCT01054404|Primary|Acceptable vs. Unacceptable Brain Relaxation at Dural Opening|"Rating of brain relaxation will be on a 4-point scale:~0 = brain very relaxed under dura, acceptable~= brain adequately relaxed under dura, acceptable~= brain slightly tense under dura, acceptable~= brain very tense under bulging dura, unacceptable"|just prior to dural opening for each subject|||units on a scale 0-3||Standard Error|Mean
75290|NCT01054339|Secondary|Changes in Serum Total Alpha-1 Antitrypsin Concentrations|The change in serum total alpha-1 antitrypsin concentration was calculated as the difference between the mean values at the screening and baseline visits and the mean values at the 6, 9 and 12 month visits. The standard error of the difference was calculated as sqrt(s1^2/n1 + s2^2/n2, where s1 is the standard deviation of the baseline mean, s2 is the standard deviation of the month 6-12 mean, n1 is the number of baseline values and n2 is the number of month 6-12 values.|During months 6-12 after study agent adminstration|Analysis bsed on all subjects enrolled in study.||micromolar||Standard Error|Mean
75291|NCT01054339|Secondary|Changes in Serum M-specific Alpha-1 Antitrypsin Concentration|The change in serum M-specific alpha-1 antitrypsin concentration was calculated as the difference between the mean values at the screening and baseline visits and the mean values at the 6, 9 and 12 month visits. The standard error of the difference was calculated as sqrt(s1^2/n1 + s2^2/n2, where s1 is the standard deviation of the baseline mean, s2 is the standard deviation of the month 6-12 mean, n1 is the number of baseline values and n2 is the number of month 6-12 values.|During months 6-12 after study agent adminsitration|One subject in low dose group had AAT phenotype SZ, which made measurement of M-specific serum alpha-1 antitrypsin concentration invalid.||nanomolar||Standard Error|Mean
75292|NCT01054339|Primary|Frequency of Grade 3 or 4 Adverse Events||During 1 year after study agent administration|Analysis based on all subjects enrolled in study.||participants|||Number
75293|NCT01054222|Secondary|King’s Health Questionnaire (KHQ) Domain Scores|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.|Baseline, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
75294|NCT01054222|Secondary|Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)|OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication’s ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as ‘very satisfied’, ‘somewhat satisfied’, ‘neither dissatisfied nor satisfied’, ‘somewhat dissatisfied’, and ‘very dissatisfied’. The results for Q9 to 11 are reported as “satisfied” (participants who answered ‘very satisfied’ or ‘somewhat satisfied’ for all 7 questions) or “not satisfied” (participants who answered ‘neither dissatisfied nor satisfied’ or ‘somewhat dissatisfied’ or ‘very dissatisfied’ for all 7 questions).|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||participants|||Number
75295|NCT01054222|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
75296|NCT01054222|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
75297|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||Participants|||Number
75298|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||Participants|||Number
75299|NCT01054222|Secondary|Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours|The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.||Units per 24 hours||Standard Deviation|Mean
75300|NCT01054222|Secondary|Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.||Percentage of Participants|||Number
75301|NCT01054222|Secondary|Percentage of Incontinent Participants at Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary.||Percentage of Participants|||Number
75302|NCT01054222|Secondary|Daily Sum Rating on the Urinary Sensation Scale (USS)|The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Numerical decrease indicates improvement.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||Units on a Scale||Standard Deviation|Mean
75303|NCT01054222|Secondary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
75304|NCT01054222|Secondary|Mean Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||micturitions per 24 hours||Standard Deviation|Mean
75327|NCT01054170|Secondary|Pre-bronchodilator Specific Airway Conductance (SGaw)|Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||1/[s*kPa]||Standard Error|Least Squares Mean
75305|NCT01054222|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||micturitions per 24 hours||Standard Deviation|Mean
75306|NCT01054222|Secondary|Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours|The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 4 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
75307|NCT01054222|Secondary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
75308|NCT01054222|Primary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|End of Treatment (up to Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. Missing values were imputed using last observation carried forward (LOCF).||episodes per 24 hours||Standard Deviation|Mean
75309|NCT01054183|Primary|Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL).|Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).|30 days; no long-term outcome measures were included|The study was powered for 62 patients per study arm. Due to slow patient enrollment, the study was stopped prior to full enrollment with the aforementioned 22 total patients.||Percent of successful intubations|Participants||Number
75310|NCT01054183|Primary|Percent of Participants With Successful 1st Intubation Attempt|Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)|30 days|||Percent of Participants|||Number
75311|NCT01054170|Secondary|Exacerbations|Number of patients experiencing disease exacerbations on treatment.|Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Participants|||Number
75312|NCT01054170|Secondary|Percentage of Reliever Free Days in Last Six Weeks of Treatment|Percentage of reliever free days in last 6 weeks on treatment.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||percentage of days||Standard Error|Least Squares Mean
75313|NCT01054170|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
75314|NCT01054170|Secondary|EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Total Score||Standard Error|Least Squares Mean
75448|NCT01051856|Primary|Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation|Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.|90 days from the operation|Intention-to-treat analysis||percentage of subjects|||Number
75316|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75317|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75318|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Evening (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
75319|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Morning (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
75320|NCT01054170|Secondary|Post-bronchodilator Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75321|NCT01054170|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75322|NCT01054170|Secondary|Post-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75323|NCT01054170|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75324|NCT01054170|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75325|NCT01054170|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75326|NCT01054170|Secondary|Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)|Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||mmol/kPa*min||Standard Error|Least Squares Mean
75591|NCT01050673|Secondary|Time of Actual Excision Procedure||28 days|||Time (Minutes)||Standard Deviation|Median
75328|NCT01054170|Secondary|Pre-bronchodilator Residual Volume (RV)|Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75329|NCT01054170|Secondary|Pre-bronchodilator Functional Residual Capacity (FRC)|Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75330|NCT01054170|Secondary|Pre-bronchodilator Total Lung Capacity (TLC)|Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75331|NCT01054170|Secondary|Pre-bronchodilator Inspiratory Capacity (IC)|Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
75332|NCT01054170|Secondary|Air Trapping Index (ATI) on Expiratory Scans|ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ATI Percentage||Standard Error|Least Squares Mean
75333|NCT01054170|Secondary|5th Generation Wall Area Percentage|5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Percentage Area||Standard Error|Least Squares Mean
75334|NCT01054170|Primary|AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)|AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||mm||Standard Error|Least Squares Mean
75335|NCT01054079|Primary|Rate of Rise of Serum PSA|The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant’s post PSA level.|24 weeks|||Nanograms Per Milliliter||Inter-Quartile Range|Median
75336|NCT01053988|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.||Minutes||Full Range|Median
75337|NCT01053988|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.||Liters||Standard Error|Least Squares Mean
75391|NCT01052948|Primary|Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up|Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
75338|NCT01053988|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an ‘Other’ endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Scores on a scale||Standard Error|Least Squares Mean
75339|NCT01053988|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
75340|NCT01053988|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis||Liters||Standard Error|Least Squares Mean
75341|NCT01053897|Secondary|Manchester Scar Scale (MSS)|"Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales.~MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions.~Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4).~Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4).~Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4).~Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)|||units on a scale||Standard Deviation|Mean
75342|NCT01053897|Secondary|Patient Observer Scar Assessment Scale (POSAS)|"Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse).~Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)|All subjects were included||units on a scale||Standard Deviation|Mean
75343|NCT01053897|Secondary|Overall Scar Preference|Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.|12 Month (End of Study)|All Subjects included.||participants|||Number
75344|NCT01053897|Primary|Photography- Independent Scar Assessment Panel|An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.|0.5, 1, 2, 3, 6, 9 and 12 Months|All subjects had scar photography completed at study visits. However, due to the early termination of this trial, the independent panel review was not completed.|||||
75345|NCT01053819|Secondary|A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria||Patients will complete the study within 6 months||||||
75346|NCT01053819|Primary|The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.||Patients will complete study within 6 months.|||participants|||Number
75347|NCT01053663|Secondary|Number of Participants With Oseltamivir Resistance Mutation|Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).|Up to Day 30|Safety population.||participants|||Number
75392|NCT01052844|Primary|Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy|6 days|||participants|||Number
75348|NCT01053663|Secondary|Number of Participants With Greater Than or Equal to (≥) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either ≥5 times change in the NAI IC50 visit value from the Reference value at a visit or ≥5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Days 1, 3, 4, 6, 15|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.||participants|||Number
75349|NCT01053663|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
75350|NCT01053663|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
75351|NCT01053663|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
75352|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
75353|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
75354|NCT01053663|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
75355|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
75356|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
75357|NCT01053663|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
75358|NCT01053507|Secondary|Migraine Specific Quality of Life Questionnaire (MSQ)||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
75359|NCT01053507|Secondary|Headache Impact Test-6 (HIT-6) Score||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
75360|NCT01053507|Secondary|Mental Efficiency Workload Test (MEWT) Performance Index||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
75361|NCT01053507|Primary|Associated Headache Symptoms|Change in number of associated headache symptoms at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
75362|NCT01053507|Primary|Headache Days|Change in number of headache days at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.|||||
75363|NCT01053429|Other Pre-specified|Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement|DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicates a positive subjective response (compliant); a negative score indicates non-compliance.|Baseline up to Week 8|Safety analysis set. It was recommended to use the optional DAI-10 tool to gather additional information for the improvement score under usual practice. The optional DAI-10 tool was not used during the study.||participants|||Number
75375|NCT01053156|Secondary|VAS Categorized by Behavior:Language/ Cognition|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with language or cognitive symptoms.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding language or cognition symptoms were placed into this category. As not every caregiver named a behavior related to language or cognition, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
75364|NCT01053429|Other Pre-specified|Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline up to Week 8|Safety analysis set: all participants who received at least 1 dose of study treatment. It was recommended to use the optional BPRS tool to gather additional information for the improvement score under usual practice. The optional BPRS tool was not used during the study.||particpants|||Number
75365|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|PP; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).||participants|||Number
75366|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|ITT; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).||participants|||Number
75367|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Per Protocol population (PP): participants in ITT group with study treatment for at least 8 (± 1 week) since enrollment and observed for final efficacy (inpatient visit or phone call). N=participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).||participants|||Number
75368|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Intent to treat population (ITT): administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).||particpants|||Number
75369|NCT01053312|Secondary|Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.|Post-contrast Administration|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.||Percentage of Plaque|||Number
75370|NCT01053312|Primary|Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.|This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.|Post-contrast administration|||Percent plaque area|||Number
75371|NCT01053312|Primary|Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.|Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region.|Post-contrast administration|||Standard Uptake Value Ratio (SUVR)|||Number
75372|NCT01053247|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).||2 weeks||||||
75373|NCT01053247|Primary|Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment||2 weeks|||participants|||Number
75374|NCT01053156|Secondary|VAS Categorized by Behavior: Other|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with other behaviors that were not able to be categorized.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors not falling into the other categories were placed into this category. As not every caregiver named a behavior unrelated to the other categories, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
75393|NCT01052844|Primary|Number of Patients With Complete Response During Chemotherapy Course 1|The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)|5 days|||participants|||Number
75806|NCT01047839|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and upt to Month 7||||||
75376|NCT01053156|Secondary|VAS Categorized by Behavior:Anxiety/ Mood|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with anxiety or mood related behaviors.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding anxiety or mood symptoms were placed into this category. As not every caregiver named a behavior related to anxiety or mood, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
75377|NCT01053156|Secondary|VAS Categorized by Behavior: Aggression/ ADHD|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with aggression or ADHD behaviors.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding ADHD or Aggression symptoms were placed into this category. As not every caregiver named a behavior related to ADHD or aggression, this number is less than the number of participants.||units on a scale||Standard Error|Least Squares Mean
75378|NCT01053156|Secondary|Visual Analogue Scale Behavior 3- VAS3|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the third behavior that caregivers noted, out of three.|Baseline, 3 months, 6 months|This behavior was not provided by all of the participating caregivers, and so the number is less than the participants analyzed for other measures.||units on a scale||Standard Error|Least Squares Mean
75379|NCT01053156|Secondary|Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score|The ABC-C composite scores were used to quantify the severity of a patient’s behaviors. A composite score consists of subscale scores including Irritability and Agitation, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity and Noncompliance, and Inappropriate Speech. The composite score may range from 0-174. Lower scores indicate improvement.|Baseline, 3 months, and 6 months|||units on a scale||Standard Error|Least Squares Mean
75380|NCT01053156|Secondary|Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score|The VABS-II Adaptive Behavior Composite Score was used to assess adaptive skills. An Adaptive Behavior Composite Score may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.|Baseline, 3 months, and 6 months|||units on a scale||Standard Error|Least Squares Mean
75381|NCT01053156|Secondary|Expressive Vocabulary Test-2|The EVT-2 standard score assesses language development through a participant’s one word synonym response to visual stimuli. Standard scores range from 20-160. A standard score of 100 is average, with a 15 point standard deviation. Higher values represent a better outcome.|Baseline, 3 months and 6 months|||units on a scale||Standard Error|Least Squares Mean
75382|NCT01053156|Secondary|Visual Analogue Scale- Behaviors 2|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the second behavior that the caregivers noted, out of three.|Baseline, 3 months, 6 months|||units on a scale||Standard Error|Least Squares Mean
75383|NCT01053156|Primary|Visual Analogue Scale- Behavior 1|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the first behavior that the caregivers noted, out of three.|Baseline, 3 months, 6 months|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis||units on a scale||Standard Error|Least Squares Mean
75384|NCT01053156|Primary|Clinical Global Impression Scale (CGI)|The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 “very much improved” to 7 “very much worse”. Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner.|3 months (post first treatment) and 6 months (post second treatment)|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis||units on a scale||Standard Error|Least Squares Mean
75385|NCT01053078|Secondary|Rates of Hypoglycemia||1 month||||||
75386|NCT01053078|Primary|Cerebral Blood Flow||1 month|||percentage of signal intensity change||Standard Deviation|Mean
75387|NCT01053000|Primary|Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline.||12 weeks|||lesions||Standard Deviation|Mean
75388|NCT01052948|Primary|Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up|All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
75389|NCT01052948|Primary|Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up|Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
75390|NCT01052948|Primary|Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up|Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis|Up to 12 years|Per protocol.||Participants/10,000 Participant-Years|||Number
75394|NCT01052831|Secondary|Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)|The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale (QUIP-RS) was developed for use in clinical trials and added as a secondary outcome measure for assessment of change in severity of ICD symptoms, to be completed at baseline and end of study only. For the QUIP-RS, scores for each compulsive behavior range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. Given that ICD symptoms are frequently comorbid in patients with PD, total QUIP-RS ICD scores (range from 0 to 64) were used to compare overall severity of ICD symptoms. Please note that this measure is reporting a change from baseline.|The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).|A linear mixed-effects model was used to estimate changes in QUIP-RS ICD scores from baseline to termination (visit 5, 8 weeks after baseline). Positive estimated change values represent a decrease in severity (frequency) of symptoms.||Change in points on a scale (QUIP-RS)||95% Confidence Interval|Number
75395|NCT01052831|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale. For the change in response status over time, a generalized estimating equation (GEE) model was used."|The CGI-I was administered at Visit 2 (week 2, two weeks after baseline) and Visit 5 (week 8, termination visit 8 weeks after baseline).|||percentage of responders|||Number
75396|NCT01052662|Primary|Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8|Calculated survival curve from abstinence in Week 8 to first positive opioid urine screen or first reported relapse to opioid use to evaluate the effect of memantine on reducing early relapse and after rapid buprenorphine discontinuation on week 9. The last observation carried forward (LOCF) was used to perform our event survival analyses.|Weeks after buprenorphine discontinuation week 9|Participants that achieved complete abstinence by self-report that was confirmed with negative urine toxicology at week 8.||participants|||Number
75397|NCT01052662|Secondary|Treatment Retention|Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.|Weekly|Intent-treat-sample (ITT) that was inducted onto buprenorphine / naloxone and received one dose of study medication on week 2.||weeks in treatment||95% Confidence Interval|Mean
75398|NCT01052662|Primary|Change of Opioid Use From Week 1 to 13|The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.|Weekly from week 1 to 13|80 subjects intent-to-treat.||Mean Proportion of Opioid Use in Week 13||Standard Error|Mean
75399|NCT01052545|Primary|Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)||Years 1, 2, & 3|The number of CAUTI undertreated in Arm 1=27, the number of CAUTI undertreated in Arm 2=17||cases/1,000 bed-days||95% Confidence Interval|Number
75400|NCT01052545|Secondary|Patient Level Analysis of Inappropriate Antibiotic Use|We looked at the percentage of cases of ASB (asymptomatic bacteriuria) that were inappropriately over-treated with antibiotics, and we also looked at the percentage of cases of CAUTI (catheter-associated UTI) that were not treated with antibiotics (under-treated).|three years|All patients on acute medical care wards or extended care wards during the three year study project who had a positive urine culture associated with the presence of a urinary catheter.||percentage of cases|||Number
75401|NCT01052545|Primary|Urine Cultures Ordered|Number of urine cultures collected per 1000 catheter-days for each unit|three years|For this outcome measure, the number of participants is the number of patients that had urine cultures ordered. One patient could have multiple cultures ordered. Arm 1=5209 urine cultures ordered. Arm 2=5979 urine cultures ordered. This number was standardized by bed-days. Arm 1=170345 bed-days. Arm 2=119409 bed-days.||Total ucx ordered/1,000 bed-days||95% Confidence Interval|Number
75402|NCT01052545|Secondary|Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit||One year||||||
75403|NCT01052545|Secondary|Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines||one year||||||
75404|NCT01052545|Secondary|Clinicians' Awareness of and Familiarity With the ABU Guidelines.||one year||||||
75405|NCT01052545|Secondary|Number of Days Antibiotics Are Given to Treat ABU||one year||||||
75406|NCT01052545|Primary|Number of Cases of ABU That Are Treated Inappropriately With Antibiotics||Years 1, 2, & 3|The number of ASB treated in Arm 1= 180, the number of ASB treated in Arm 2= 65||cases/1,000 bed-days||95% Confidence Interval|Number
75407|NCT01052428|Primary|Peak Early Filling Rate: Rate of Change Over Time|Peak Early Filling Rate The peak early filling rate of change is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||EDV/sec||Standard Deviation|Mean
75408|NCT01052428|Primary|Systolic Longitudinal Strain|Systolic Longitudinal Strain. By identifying two points on the heart, the strain is the difference between the distance between these two points at the end of filling of the heart and the end of contraction divided by the length at the end of filling. Thus, the measure is like the ejection fraction, however the strain is more localized to a specified segment in the heart muscle. The higher values indicate a healthy heart.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent/%Systolic interval||Standard Deviation|Mean
75409|NCT01052428|Primary|Left Ventricular Ejection Fraction|Left Ventricular Ejection Fraction Is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent||Standard Deviation|Mean
75422|NCT01052207|Secondary|Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline.||2 years||||||
75807|NCT01047839|Secondary|Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination||7 days||||||
75410|NCT01052428|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area|Left Ventricular End Systolic Volume Indexed to Body Surface Area As an indicator of heart size, the blood volume of the heart is related to the body size. The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
75411|NCT01052428|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness|Left Ventricular End-Diastolic Radius to Wall Thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||unitless||Standard Deviation|Mean
75412|NCT01052428|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||g/ml||Standard Deviation|Mean
75413|NCT01052428|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area|Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
75414|NCT01052272|Primary|Peak Early Filling Rate Normalized to EDV|The Peak Early Filling Rate Normalized to EDV is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||1/sec||Standard Deviation|Mean
75415|NCT01052272|Primary|LV End Systolic Maximum Shortening (LVES Max Shortening)|By identifying three points in three different planes in the heart muscle, the maximum shortening is the average of the difference between the distance between these three points at the end of filling of the heart and the end of contraction divided by the length at the end of filling times 100. The maximum shortening is a three dimensional analysis. The higher values indicate a healthy heart. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent of length at end of filling||Standard Deviation|Mean
75416|NCT01052272|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)|LVESV/BSA: The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
75417|NCT01052272|Primary|Left Ventricular Ejection Fraction (LVEF)|LVEF is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes|5 visits per Participant over 2 years (about every 6 months)|intent to treat||percent||Standard Deviation|Mean
75418|NCT01052272|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)|LVED Mass/LVEDV: As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||g/ml||Standard Deviation|Mean
75419|NCT01052272|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)|LVED Radius/Wall thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||unitless||Standard Deviation|Mean
75420|NCT01052272|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)|LVEDV/BSA: As an indicator of heart size, the blood volume of the heart is related to the body size. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat||ml/m^2||Standard Deviation|Mean
75421|NCT01052207|Secondary|Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker.||2 years||||||
75423|NCT01052207|Primary|Pediatric Logistic Organ Dysfunction Score in Critically Ill Children|"Pediatric Logistic Organ Dysfunction also known as the PELOD Score is a marker of severity of illness for Critically ill children. The PELOD includes six organ dysfunctions and 12 variables.~To calculate the PELOD score, each organ dysfunction received points for the single variable associated with the most points. The minimum number that can be assigned to an organ is 0 and the maximum number of points for an organ is 20, and the maximum possible PELOD score is 71. Organ dysfunction is identified if the score for any organ system was more than 0."|1 years|PELOD scores are not calculated for healthy controls. The score was developed to assess critically ill patients only.||scores on a scale||Standard Deviation|Mean
75424|NCT01052116|Primary|Mean Change From Baseline to 24 Weeks for FEV1||24 weeks|||Liters||95% Confidence Interval|Mean
75425|NCT01052077|Secondary|Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).|CGI-I Response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||participants|||Number
75426|NCT01052077|Secondary|Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.|A MADRS remission was defined as MADRS Total Score =< 10 and >= 50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||participants|||Number
75427|NCT01052077|Secondary|Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.|A MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||participants|||Number
75428|NCT01052077|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participants total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
75429|NCT01052077|Secondary|Change From End of Phase A (Week 8) to End of Phase B (Week 14) in the Hamilton Depression Rating Scale 17-item Version (HAM-D17) Total Score.|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
75430|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|The IDS-SR was a 30-item self-report measure, that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). For individual items, the scores range from 0 to 3. The IDS-SR are scored by summing responses to 28 of the 30 items to obtain a total score ranging from 0 to 84, higher values indicate greater disruption in the depressive symptoms.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
75431|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression- Severity Illness Scale (CGI-S) Score.|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
75432|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.|The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
75433|NCT01052077|Secondary|Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. Scores of 5 and above are associated with significant functional impairment. The SDS total score ranges from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
75434|NCT01052077|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the Full Analysis Set (FAS) comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
75435|NCT01052038|Secondary|Hoarseness at 24 Hours|Self assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview.|24 hours|||participants|||Number
75436|NCT01052038|Secondary|Opioid Consumption at 24 Hours|The cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine.|24 hours|||mg of oral morphine equivalents||Inter-Quartile Range|Median
75437|NCT01052038|Secondary|Number of Subjects With Sore Throat at 3 Hours Post Surgery.|Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.|3 hours.|||participants|||Number
75438|NCT01052038|Secondary|Quality of Recovery at 24 Hours|The quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery|24 hours|||units on a scale (30 to 200) higher scod||Inter-Quartile Range|Median
75439|NCT01052038|Primary|Subjects Assessment of Sore Throat Pain at 24 Hours|The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.|24 hours|||units on a scale (1 to 5)||Inter-Quartile Range|Median
75440|NCT01051986|Secondary|Early Angiographic Patency Rates|The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG|1.4days|||percentage of distal anastomoses|Participants||Number
75441|NCT01051986|Secondary|Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)|freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years|4 years|||percentage of participants|||Number
75442|NCT01051986|Secondary|Freedom From Cardiac Death|Freedom rate from cardiac death at 4 years|4 years|||percentage of participants|||Number
75443|NCT01051986|Secondary|Overall Survival|Overall survival rate at 4 years|4 years|||percentage of participiciants|||Number
75444|NCT01051986|Primary|1 Year Graft Patency Rates|1 year graft patency of second limb conduits measured by 1 year coronary angiography|one year|||percentage of distal anastomoses|Participants||Number
75445|NCT01051921|Secondary|> 2 Log Decline in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at 24 Weeks|"Percent of patients experiencing a drop in HCV-RNA Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 24 weeks of treatment."|Baseline and Study week 24|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.||Percent of patients|||Number
75446|NCT01051921|Primary|Early Virologic Response (EVR)|"Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as viral load) levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment."|Baseline and Study week 12|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.||Percent of Patients|||Number
75449|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T2 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|full analysis Set||Cumulative new Gd-T2 lesions||Full Range|Mean
75450|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T1 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|Full analysis set||cumulative new Gd-T1 lesions||Full Range|Mean
75451|NCT01051817|Primary|Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment|Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.|weeks 4,8,12,16,20,24,28|Full Analysis Set||Combined Unique Active Lesions||Full Range|Mean
75452|NCT01051778|Secondary|Spontaneous Osteoporotic Fractures||Duration of pregnancy and puerperium||||||
75453|NCT01051778|Secondary|Preterm Delivery||24 weeks gestation<Pregnancy <37weeks gestation||||||
75454|NCT01051778|Secondary|IUFD||Pregnancy >24 weeks gestation||||||
75455|NCT01051778|Secondary|Preeclampsia||Pregnancy > 20 weeks gestation||||||
75456|NCT01051778|Secondary|Thrombocytopenia||Duration of pregnancy and puerperium||||||
75457|NCT01051778|Secondary|Minor and Major Bleeding||Duration of pregnancy and puerperium||||||
75458|NCT01051778|Primary|Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)|Live birth occurs when a fetus (> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.|pregnancy > 24weeks gestation|||Percentage of pregnancies|||Number
75459|NCT01051739|Primary|Number of Subjects Progressing in Each Group Using Pointwise Linear Regression|Perimetric method that most efficiently detects visual field change. secondary outcome: number of subjects progressing in each group using pointwise linear regression Linear regression was used to determine visual field worsening (progression) at each of 52 test locations. We required 3 or more worsening test locations at a p = 0.05 significance level for their to be significant progression.|4 years|Those that completed study||participants|||Number
75460|NCT01051570|Secondary|Overall Survival||After treatment, participants will be contacted every 3 months||||||
75461|NCT01051570|Secondary|Pharmacokinetics||Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2||||||
75462|NCT01051570|Secondary|Association of TTP and PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)||Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose||||||
75463|NCT01051570|Secondary|PSA Response Rate||Day 1 of each cycle (every 21 days)||||||
75464|NCT01051570|Secondary|Toxicity as Measured by NCI CTCAE v3.0 Criteria||Day 1 of each cycle (every 21 days)||||||
75465|NCT01051570|Primary|Time to Progression (TTP)|Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.|||months||90% Confidence Interval|Median
75466|NCT01051557|Primary|Determine the Efficacy of Temsirolimus in Combination With Perifosine in Patients With Recurrent/Progressive Glioblastomas (GBMs) Not Taking EIAEDs as Measured by 6 Month Progression-free Survival (6mPFS) and Radiographic Response Rates. (Phase II)|This data has yet to be analyzed.|5 years||||||
75467|NCT01051557|Primary|Maximum Tolerated Dose of Temsirolimus|MTD defined as the dose at which fewer than one-third of patients experience a dose limiting toxicity (DLT) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)|28 days|||mg/week|||Number
75468|NCT01051466|Secondary|Incidence of Suicidal Behavior and Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captures the occurrence, severity, and frequency of treatment-emergent suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent outcomes were the worsening or new occurrence of suicidal behaviors or ideation during treatment compared with baseline."|Baseline through Week 12|Participants with MDD who had a baseline and at least 1 post-baseline C-SSRS assessment. Healthy participants did not have a C-SSRS assessment post baseline.||participants|||Number
75469|NCT01051466|Secondary|Hamilton Anxiety Rating Scale (HAMA)|The 14-item HAMA is used to assess the severity of anxiety. The investigator talked to the participant about their symptoms over the previous week. Each item was scored using a 5-point scale (0 = not present to 4 = very severe). Total HAMA scores could have ranged from 0 (normal) to 56 (severe).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMA observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
75470|NCT01051466|Secondary|Patient's Global Impressions of Improvement (PGI-I) Scale|The PGI-I scale measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores can range from 1 (very much better) to 7 (very much worse).|Baseline, up to Week 12|Enrolled MDD participants who had at least 1 post-baseline PGI-I observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome. PGI-I observations were not completed for healthy participants.||units on a scale||Standard Deviation|Mean
75471|NCT01051466|Secondary|Clinical Global Impressions of Severity Scale (CGI-S)|The CGI-S measures severity of illness at the time of assessment. Scores can range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline CGI-S observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
75472|NCT01051466|Secondary|Sheehan Disability Scale (SDS)|The SDS is a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated higher functional impairment in the participant's work/social/family life.|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline SDS observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
75473|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Remission|HAMD17 remission is defined as a HAMD17 total score of ≤7 at Week 12 (endpoint). The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with remission was calculated as the number of participants with a HAMD17 total score of ≤7 divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||percentage of participants|||Number
75474|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Response|HAMD17 response is defined as a >50% reduction in HAMD17 total score from baseline. The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with a HAMD17 response was calculated as the number of participants with a >50% reduction in HAMD17 total score from baseline divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||percentage of participants|||Number
75475|NCT01051466|Secondary|17-Item Hamilton Depression Rating Scale (HAMD17)|The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.||units on a scale||Standard Deviation|Mean
75476|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Proinflammatory Cytokines [Tumor Necrosis Factor Alpha (TNFα), Interleukin 1 (IL-1), and Interleukin 6 (IL-6)]|Cytokines are naturally produced and regulate responses to inflammation. Proinflammatory cytokines like TNFα, IL-1, and IL-6 increase inflammation in the body. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline cytokine observation (TNFα, IL-1, or IL-6), excluding 3 healthy participants who did not meet entry criteria.||picograms per milliliter (pg/mL)||Standard Error|Least Squares Mean
75477|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF) Receptors|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Tropomyosin receptor kinase B (trkB) is a receptor for BDNF, and pan-neurotrophin receptor p75 (p75NTR) is a receptor for proBDNF. p75NTR was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline trkB observation, excluding 3 healthy participants who did not meet entry criteria. No participant was analyzed for the change from baseline in p75NTR receptors.||picograms per milligram (pg/mg)||Standard Error|Least Squares Mean
75478|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF)|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline BDNF or proBDNF observation, excluding 3 healthy participants who did not meet entry criteria.||nanograms per milliliter (ng/mL)||Standard Error|Least Squares Mean
75479|NCT01051466|Secondary|Gs Alpha (Gsα)-Activated Adenylyl Cyclase|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Adenylyl cyclase is activated by Gsα, and when Gsα is translocated from lipid rafts it more effectively activates adenylyl cyclase. Gsα-activated adenylyl cyclase was not analyzed due to technical laboratory issues.|Baseline and Weeks 1, 8, and 12|No participants were analyzed.|||||
75592|NCT01050673|Primary|Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.||28 days plus 6 week follow-up|||Time (minutes)||Standard Deviation|Median
75480|NCT01051466|Secondary|Translocation of Gs Alpha (Gsα) From Lipid Rafts in the Cell Membranes of Red Blood Cells (RBCs), White Blood Cells (WBCs) and Platelets Compared With Baseline|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Gsα localization in the cholesterol-rich (lipid rafts) and cholesterol-poor regions of cell membranes of RBCs and platelets was measured with quantitative Western blots and reported as the ratio of Gsα (absorbance units) in Triton X-100 (TX-100) over Triton X-114 (TX-114), 2 detergents that discriminate between lipid raft and non-raft membrane domains. Translocation of Gsα was measured as the change from baseline in Gsα localization. Translocation of Gsα from lipid rafts in the cell membranes of WBCs was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Weeks 1, 8, and 12|Enrolled participants who had a baseline and at least 1 post-baseline Gsα localization observation, excluding 3 healthy participants who did not meet entry criteria. No participants were analyzed for the translocation of Gsα from lipid rafts in the cell membranes of WBCs.||Ratio||Standard Error|Least Squares Mean
75481|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Volume of Subgenual Anterior Cingulate, Amygdalae, and Hippocampus|The volume of specific brain regions is obtained using a structural magnetic resonance imaging (sMRI) procedure in which high-resolution spoiled gradient recall images are acquired in coronal brain slices. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline observation for the volume of specific brain regions, excluding 3 healthy participants who did not meet entry criteria.||cubic millimeters (mm^3)||Standard Error|Least Squares Mean
75482|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Activation [Blood Oxygenation-Level-Dependent (BOLD) Response to Implicit Processing of Sad Faces] for Each of the 3 Brain Regions|Functional magnetic resonance imaging (fMRI) is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces in each brain region (anterior cingulate, left amygdala and right amygdala) was measured by the percentage of signal change in BOLD response. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation, excluding 3 healthy participants who did not meet entry criteria.||percentage of signal change||Standard Error|Least Squares Mean
75483|NCT01051466|Primary|Change From Baseline to 12-Week Endpoint in the Functional Magnetic Resonance Imaging (fMRI) Mean Blood Oxygenation-Level-Dependent (BOLD) Response in the Amygdalae|Functional MRI or fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces was measured by the percentage of signal change in BOLD response from before to after sad faces processing. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Amygdala BOLD activation was calculated as an average between the left amygdala activation and right amygdala activation. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation.||percentage of signal change||Standard Error|Least Squares Mean
75484|NCT01051440|Secondary|Change in Clinical Global Impressions Improvement (CGI-I) Score.|The CGI-I score indicates the clinician's overall assessment of improvement in function from one visit to the next. The single item is scored from 1 to 7 with anchor points ranging from very much improved (1) to very much worse (7). A decrease in score reflects an improvement in functional status.|week 1 and week 9|All participants who were randomized to lisdexamfetamine or placebo were included.||units on a scale|||Number
75485|NCT01051440|Secondary|Change in Clinical Global Impressions Severity (CGI-S) Score.|"The CGI-S score reflects the clinician's overall impression of the patient's functional status. The scoring for the single item ranges from 1 with an anchor of normal, not at all ill to 7 with an anchor of among the most extremely ill patients. Thus, higher scores indicate greater severity of symptoms."|baseline and week 8|All participants who were randomized to lisdexamfetamine or placebo were included.||units on a scale|||Number
75486|NCT01051440|Primary|Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.|The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms.|baseline and 8 weeks|All participants randomized to lisdexamfetamine or placebo were included.||units on a scale|||Number
75487|NCT01051323|Secondary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint.||mcg||Standard Deviation|Mean
75488|NCT01051323|Primary|Number of Participants Satisfied With Treatment at Final Visit|Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS||participants|||Number
75489|NCT01051323|Primary|Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy|Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.||participants|||Number
75490|NCT01051323|Primary|Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion|At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.||participants|||Number
75491|NCT01051323|Primary|Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion|"At final visit, physicians were asked to answer (yes or no) the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants."|Month 12 or early discontinuation|FAS||participants|||Number
75492|NCT01051323|Primary|Number of Physicians Satisfied With Treatment at Final Visit|Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS||physicians|||Number
75493|NCT01051323|Primary|C-reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint.||mg/dL||Standard Deviation|Mean
75494|NCT01051323|Primary|Transferrin Saturation Values|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint.||percent transferrin saturation||Standard Deviation|Mean
75495|NCT01051323|Primary|Transferrin Values|Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint.||mg/dL||Standard Deviation|Mean
75496|NCT01051323|Primary|Serum Iron Values|Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint.||mcg/dL||Standard Deviation|Mean
75497|NCT01051323|Primary|Serum Ferritin Values|Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint.||ng/mL||Standard Deviation|Mean
75498|NCT01051323|Primary|Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size|For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.|Month 0 to Month 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.||g/dL||Standard Deviation|Mean
75499|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.|Month 6 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.||percentage of participants|||Number
75500|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10–12 g/dL, 11–12 g/dL, and 11–13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.|Month 0 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.||percentage of participants|||Number
75501|NCT01051323|Primary|Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range|Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.|Month 0 to Month 12|FAS||percentage of participants|||Number
75502|NCT01050998|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|ADA detection measured by using electrochemiluminescence assays.|Day 1 up to Day 169|The immunogenicity population included all participants who received at least 1 dose of CAM-3001 and for whom at least one serum sample for immunogenicity testing was available.||participants|||Number
75503|NCT01050998|Secondary|Accumulation Ratio for Mavrilimumab After Last Dose by Region|Accumulation ratio was calculated as ratio of AUCtau after last dose and AUCtau after first dose. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||ratio||Standard Deviation|Geometric Mean
75504|NCT01050998|Secondary|Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||days||Standard Deviation|Mean
75505|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||ng*day/mL||Standard Deviation|Geometric Mean
75506|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||days||Full Range|Median
75507|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||ng/mL||Standard Deviation|Geometric Mean
75508|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Geometric Mean
75509|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||days||Full Range|Median
75510|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
75511|NCT01050998|Secondary|Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose|Participants received MTX at stable and tolerated dose during baseline were categorized as “low dose (<12.5 mg per week [mg/wk])”, “medium dose (>=12.5 - <20 mg/wk)”, and “high dose (>=20 mg/wk)”. Participants received oral CST at stable dose during baseline were categorized as “low dose (<5 mg/day)”, and “high dose (>=5 mg/day)”. Change in MTX and CST dose from baseline between Day 1-85 and Day 86-169 were categorized as follows: ‘Increased’, ‘no change’ and ‘decreased’. Participants were counted once with dose increases counted first, followed by no change and then dose decreases.|Baseline, Day 1 to 85, Day 86 to 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified parameter for each arm, respectively."||participants|||Number
75512|NCT01050998|Secondary|Number of Participants Who Had Additional Medications|Additional medication included concomitant medication (medication used for purposes other than managing rheumatoid arthritis [RA]) and RA medication (for managing RA). Number of participants who used concomitant medication and RA medication was reported by anatomical therapeutic chemical (ATC) classification system.|Baseline up to Day 169|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||participants|||Number
75593|NCT01050660|Secondary|Anthropometric Measurements(Head Circumference)|Change in head circumference measurement reported in cm/week|At age of 28 days and at discharge|||cm/week||Standard Deviation|Mean
75513|NCT01050998|Secondary|Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units per milliliter||Standard Deviation|Mean
75514|NCT01050998|Secondary|Serum Concentration of Rheumatoid Factor (RF)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units per milliliter||Standard Deviation|Mean
75515|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||mm/hr||Standard Deviation|Mean
75516|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm/hr||Standard Deviation|Mean
75517|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP) by Region|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||mg/L||Standard Deviation|Mean
75518|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mg/L||Standard Deviation|Mean
75519|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score by Region|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Deviation|Mean
75520|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
75521|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Deviation|Mean
75522|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Deviation|Mean
75523|NCT01050998|Secondary|Patient Pain Assessment Score by Region|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||mm||Standard Deviation|Mean
75594|NCT01050660|Secondary|Anthropometric Measurements(Length)|Change in body length measurement reported in cm/week|At age of 28 days and at discharge|||cm/week||Standard Deviation|Mean
75524|NCT01050998|Secondary|Patient Pain Assessment Score|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm||Standard Deviation|Mean
75525|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score by Region|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly. Data for European and Japanese regions were reported."|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||mm||Standard Deviation|Mean
75526|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||mm||Standard Deviation|Mean
75527|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score by Region|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||cm||Standard Deviation|Mean
75528|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score|Physician Global Assessment of Arthritis was measured on a 0 to 10 centimeter (cm) Visual Analogue Scale (VAS), where 0 cm = very good and 10 cm = very bad.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||cm||Standard Deviation|Mean
75529|NCT01050998|Secondary|Swollen and Tender Joint Count by Region|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Data for the European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||joints||Standard Deviation|Mean
75530|NCT01050998|Secondary|Swollen and Tender Joint Count|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||joints||Standard Deviation|Mean
75531|NCT01050998|Secondary|Continuous ACR (ACRn) Score by Region|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Error|Mean
75532|NCT01050998|Secondary|Continuous ACR (ACRn) Score|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Error|Mean
75533|NCT01050998|Secondary|Number of Participants Who Achieved ACR Categorical Responses|"ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. ACR responses were categorized as No response, ACR20 but not ACR50, ACR50 but not ACR70, and ACR70."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||participants|||Number
75534|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region|ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Data for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percentage of participants|||Number
75535|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85|ACR20, ACR50, and ACR70, were defined as greater than or equal to (>=) 20 percent (%),>=50%, or >=70% improvement, respectively, in: swollen joint count and tender joint count and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
75536|NCT01050998|Secondary|Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Expected duration of response (DOR) was calculated as response rate (in percentage) multiplied by mean DOR (in days) by using Weibull Model. Duration of DAS28 (CRP) and DAS28 (ESR) remission were not analyzed because very few participants achieved remission in the overall study population.|Baseline up to Day 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified parameter for each arm, respectively."||Percentage of days|||Number
75537|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved.|Baseline up to Day 169 (follow-up)|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||days||95% Confidence Interval|Median
75538|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score.|Baseline up to Day 169 (follow-up)|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||days||95% Confidence Interval|Median
75539|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percentage of participants|||Number
75540|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
75595|NCT01050660|Secondary|Anthropometric Measurements(Body Weight)|Change in body weight measurement reported in g/week|At age of 28 days and at discharge|||g/week||Standard Deviation|Mean
75541|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||units on a scale||Standard Error|Mean
75542|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."||units on a scale||Standard Error|Mean
75543|NCT01050998|Primary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite).|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
75544|NCT01050998|Primary|Change From Baseline in Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||percent saturation||Standard Deviation|Mean
75545|NCT01050998|Primary|Oxygen Saturation Level at Day 85 by Region|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percent saturation||Standard Deviation|Mean
75546|NCT01050998|Primary|Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||percent saturation||Standard Deviation|Mean
75547|NCT01050998|Primary|Categorized Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above).|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||participants|||Number
75548|NCT01050998|Primary|Change From Baseline in Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||units on a scale||Standard Deviation|Mean
75549|NCT01050998|Primary|Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||units on a scale||Standard Deviation|Mean
75550|NCT01050998|Primary|Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||percent diffusion capacity||Standard Deviation|Mean
75551|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."||percent diffusion capacity||Standard Deviation|Mean
75552|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||percent diffusion capacity||Standard Deviation|Mean
75553|NCT01050998|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."||liters||Standard Deviation|Mean
75554|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC at Day 85 for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."||liters||Standard Deviation|Mean
75555|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 85|The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.||liters||Standard Deviation|Mean
75556|NCT01050998|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Results|12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator’s discretion were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
75557|NCT01050998|Primary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
75558|NCT01050998|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.||participants|||Number
75559|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1. DAS28 (ESR) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
75560|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
75561|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
75562|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
75563|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. DAS28 (ESR) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
75564|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
75565|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."||percentage of participants|||Number
75566|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Day 85|The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.||percentage of participants|||Number
75567|NCT01050946|Secondary|Disease-free Survival:Death or Relapse Will be Considered Events for This Endpoint.||3 years|||participants|||Number
75568|NCT01050946|Secondary|Transplant Related Mortality (TRM): TRM is Death Occurring in Patients in Continuous Complete Remission.||1 year|only pt who was enrolled died of TRM||participants|||Number
75569|NCT01050946|Secondary|Time to Acute GVHD: We Will Assess the Incidence and Severity of Grades II-IV and Grades III-IV Acute GVHD From Day of Transplant.||100 days|only one participant - no analysis done|||||
75570|NCT01050946|Secondary|Time to Platelet Engraftment: To Assess the Incidence of Platelet Engraftment From Day of Transplant,||100 days|No further analysis reported as only one patient enrolled|||||
75571|NCT01050946|Secondary|Time to Neutrophil Engraftment: To Assess the Incidence of Neutrophil Engraftment From Day of Transplant|time to neutrophil recovery after transplant|100 days|Patient engrafted neutrophils and platelets but no statistical analysis possible|||||
75572|NCT01050946|Secondary|Time to Relapse: To Assess the Incidence of Acute Leukemia or Lymphoma Relapse From Day of Transplant|NOT analyzed since there was only patient and no relapse was observed till patient passed away|2 years|Patient did not live to 2 years, no relapse observed|||||
75573|NCT01050946|Primary|The Primary Objective is to Estimate the Overall Survival, Separately in the Two Risk Strata.||3 years|Only one patient enrolled on study. Patient died prior to time frame of 3 years. It is not possible to assess this outcome measure.|||||
75596|NCT01050660|Secondary|Length of Stay|Defines time to discharge or death.|At discharge from Newborn ICU/death|||Days||Inter-Quartile Range|Mean
75597|NCT01050660|Secondary|Late Onset Sepsis|Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.|At the discharge from Newborn ICU|||participants who developed LOS|||Number
75598|NCT01050660|Secondary|Incidence of Retinopathy of Prematurity (ROP)||At discharge from Newborn ICU|||participants who developed ROP|||Number
75574|NCT01050816|Secondary|Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery|The Modified Hannover Score System contains information about patient’s status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)||scores||Standard Deviation|Mean
75575|NCT01050816|Secondary|Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery|"A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.~The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point."|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)||mm||Standard Deviation|Mean
75576|NCT01050816|Primary|Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery|"AOFAS scores(best score-100,worst score- 0 )~pain-none:40/Strong and Always present:O~Function~activities-without support activities:10/need restrain, clutch , walker or wheelchair:0~Maximum gait distance- more than 6:5/ less than 1:0~gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0~Gait abnormality-none:8/marked:0~saggital mobidity- normal or minimal restrain:6/strong restraint:0~hindfoot mobidity -normal minimal restrain:6/strong restrain:0~ankle and hindfoot stability - stable:8/unstable:0~alignment- good:10/bad:0"|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for Full Analysis Set(FAS) analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)||scores||Standard Deviation|Mean
75577|NCT01050790|Secondary|CTA Expression Before and After Azacitidine Therapy|Six patients tested have demonstrated CTA up-regulation in either unfractionated bone marrow (n = 4) or CD138+ cells (n = 2). CTA (CTAG1B)-specific T cell response has been observed in all three patients tested and persists following SCT.|3 months|||participants|||Number
75578|NCT01050790|Secondary|Pre- and Post-ALI Immune Response to Cancer Testis Antigens (CTA)|Not able to obtain outcome data.|6 months|Not able to obtain outcome data. The lab doing this correlative analysis lost the personnel support to process the samples.|||||
75579|NCT01050790|Secondary|Progression-free and Overall Survival|"Survival and event-free survival curves (any event of fatality, relapse, acute or chronic GVHD) with Kaplan-Meier curves. The incidence curve for relapse – accounting for the competing risk of fatality – is plotted with step-wise curves. The R statistical software (version 2.15) was used for all time-to-event analyses, with the survival package used for survival curves, and the cmprsk package used for all competing risk curves.~Results: The one-year survival rate is 93.3% (SE = 0.4%), and the two-year survival rate is 86.1% (SE = 0.9%)."|1 year to 2 years|The outcome measure data was collected up to one to two years post transplant.||percentage of participants||95% Confidence Interval|Number
75580|NCT01050790|Secondary|Time to Progression Post Transplant|Time to progression post transplant: For patients not in Complete Response (CR), progressive disease requires one or more: >25% increase in the level of the serum monoclonal paraprotein(absolute increase of at least 0.5 g/dL); > 25% increase in 24-hour urinary light chain excretion(absolute increase of at least 200m/24 hours). Increase plasma cells in a bone marrow aspirate( absolute increase of at least 10%). Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum Ca > 11.5 mg/dL or > 2.65 mmol/L) not attributable to any other cause. All relapse categories require two consecutive assessments made any time before classification as relapse or progressive disease.|28 months|Progression is collected anytime after transplant.||months||Full Range|Median
75581|NCT01050790|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Time frame includes after stem cell transplant engraftment. Toxicity post ALI infusion: 1 patient grade 1 hypertension 90 min post infusion. Toxicity post Rev maintenance: 1 patient not tolerated, 1 patient dose decreased due to counts.|6 months|||participants|||Number
75582|NCT01050790|Secondary|Complete Response Rate at 6 Months|16 of 17 patients proceeded to transplant. 6 month CR rate post transplant was 8/16 (50%).|6 months|1 patient did not proceed to transplant.||percentage of participants|||Number
75583|NCT01050790|Primary|Feasibility to Mobilize and Infuse Autologous Lymphocytes (ALI) After Immunomodulatory Therapy and After Stem Cell Transplant Engraftment|Time frame is post 2nd and 3rd cycles of rev/aza and after stem cell transplant engraftment.|6 months|17 of 17 patients were able to mobilize lymphocytes. 16 of 17 patients had lymphocytes infused post transplant. 1 patient was not able to mobilize stem cells and so did not go to transplant.||participants|||Number
75584|NCT01050673|Secondary|Number of Patient's With Serious Adverse Events and Relationship to Device||28 days|||Number of patients|||Number
75585|NCT01050673|Secondary|Number of Patient's With Wound-related Readmissions||28 days and 6 week follow up|||Number of patients|||Number
75586|NCT01050673|Secondary|Length of Hospital Stay (1st Excision to Discharge (Days))||28 days|||Days||Standard Deviation|Median
75587|NCT01050673|Secondary|Percentage of Patients Achieving Stable Closure Within Study Period||28 days|||percentage of patients|||Number
75588|NCT01050673|Secondary|Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure||28 days|Pre and post-excision values added, (cfu/g) tissue.||cfu/g||Standard Deviation|Median
75589|NCT01050673|Secondary|Cost of Reference Wound-related Surgical Procedures to Achieve Closure||28 days|||Dollars ($)||Standard Deviation|Mean
75590|NCT01050673|Secondary|Cost Per Operative Procedure||28 days|||Dollars $||Standard Deviation|Mean
75602|NCT01050660|Primary|The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer.||28 days of age or when full enteral nutrition is acheived, whichever is longer|"Incidence of PNALD at Yale and UCLA NICU prior to the start of the study was around 40%.~Our goal was to decrease incidence by 50%/ Alpha of 5%/ Power of 80% We calculated a sample size of 65 infants in each group"||participants who developed Cholestasis|||Number
75603|NCT01050634|Primary|Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26|The 3 LASA items concerning vaginal symptoms (discharge, dryness, itching/irritation) were combined as the sum of these 3 items. Lower scores corresponded to better QoL, with negative changes from baseline corresponding to improvements in vaginal symptoms. Total overall score range=0-300, Best score=0, Worst score=300|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.||Scores on a scale (mm)||Standard Deviation|Mean
75604|NCT01050634|Primary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores|Items: 1.General health 1=poor to 5=excellent 2.Limited moderate activities & 3.Climbing of stairs 1=lot to 3=not at all 4.Accomplished less & 5.Limited in kind of work due to physical health, 6.Accomplished less & 7.Work done less carefully due to emotional problems 1=yes, 2=no 8.Pain interfered with work 1=extremely to 5=not at all 9.Felt calm & 10.Had lot of energy 1=none to 6=all time 11.Felt downhearted & 12.Physical health/emotional problems interfered with social activities 1=all time to 6=none of the time. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.||Scores on a scale||Standard Deviation|Mean
75605|NCT01050634|Primary|Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26|Assessment of severity of 13 items (Being irritable, Sweats, Vaginal discharge, dryness, and itching/irritation, Sleep disturbance, Feeling dizzy, Headaches, Bone or joint pain, Troubled by weight gain, Loss of sexual interest, Difficulties in becoming aroused – all from none to severe, and Bothered by treatment related difficulties (not at all to severely). Individual items scored by measuring distance in mm between left scale anchor and patient’s mark, where no severity=0mm, maximum severity=100mm and negative changes from baseline=lessening of severity.Score range=0-100|Baseline, Month 12|FAS=Number of participants analyzed. Missing values were imputed by LOCF. Number of subjects analyzed for single LASA item (n)=Number of subjects with Baseline and Final Visit (LOCF) scores for the single item.||mm||Standard Deviation|Mean
75606|NCT01050634|Primary|Change From Baseline in Thickness of Endometrium|"Ultrasound measurement. New derived variable for normalization of endometrium thickness:~1 = Endometrium thickness <=5mm 0 = Endometrium thickness >5mm"|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) values.||mm||Standard Deviation|Mean
75607|NCT01050634|Primary|Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores|10 single-item in LASA format(100mm scale): Physical wellbeing (good to lousy); Mood (happy to miserable); Tiredness, Hot flushes, Feeling sick, Use of arm restricted - all none to a lot; Appetite (good to none); Effort to cope with illness (no effort to great deal of effort); Supported by people (much to not at all); Rating life in current condition (perfect to worst health). Individual items scored by measuring distance in mm between left scale anchor and patient’s mark, where best QoL=0mm, worst QoL =100mm, and negative changes from baseline=improvement in QoL.Score range=0-100|Baseline, Month 12|Full Analysis Set (FAS)=Subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy measurement=Number of participants analyzed. Missing values were imputed by last observation carried forward (LOCF). Subjects analyzed for single item (n)=Subjects with Baseline and Final Visit (LOCF) scores for the item||mm||Standard Deviation|Mean
75608|NCT01050582|Secondary|Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events|Previous potentially prolactin-related adverse events, including hyperprolactinemia, were reviewed and abstracted from participants' medical records. Potentially prolactin-related adverse events include breast symptoms, menstrual disorders, hyperprolactinemia, and prolactinoma.|Retrospectively during the time of exposure for up to 2 years prior to the study visit|||participants|||Number
75609|NCT01050582|Secondary|Age (Years) at Current Tanner Stage|Tanner stage is an evaluation of pubertal development with values ranging from 1 (pre-pubertal) to 5 (adult). A standardized, validated tool containing standardized pictures and written descriptions of the stages of pubic hair development, breast development for girls, and genital development for boys was used by physicians to make their assessment.|One single study visit, approximately one week after informed consent has been obtained|Participants with a physician assessed Tanner stage value.||years||Standard Deviation|Mean
75610|NCT01050582|Primary|Height (cm) Z-score at Study Visit|Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.|One single study visit, approximately one week after informed consent has been obtained|All participants with a height assessment available at the study visit.||z-score||Standard Deviation|Mean
75611|NCT01050569|Secondary|Time to Lapse or Relapse to Tobacco Use||26 weeks|||weeks||95% Confidence Interval|Median
75612|NCT01050569|Secondary|Exposure to Tobacco Toxicants||6 weeks|||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
75613|NCT01050569|Primary|End of Follow-up Abstinence Rates|CO- and cotinine-verified point prevalence abstinence|36 weeks|||participants|||Number
75614|NCT01050569|Primary|End of Treatment Abstinence Rate|Cotinine and carbon monoxide (CO) verified point prevalence abstinence|12 week|||participants|||Number
75629|NCT01050218|Primary|Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS).|The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.|Baseline and 9 months|The efficacy population was the intent-to-treat (ITT). This included all randomized subjects who had a baseline primary efficacy evaluation, had taken at least 1 dose of test article, and had at least 1 primary efficacy evaluation (ie, at least 1 NRS daily pain score) after the first dose of test article. No participants met that criterion.||units on scale|||Number
75615|NCT01050543|Primary|Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (height) of the 1st & 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated complete recovery.|From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)|Full Analysis Set, defined as all participants who received randomized treatment and had at least one efficacy measurement.||minutes||95% Confidence Interval|Geometric Mean
75616|NCT01050530|Secondary|Ascites Volume|Change in ascites volume from baseline as measured by CT at end of treatment|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF||mL||Standard Deviation|Mean
75617|NCT01050530|Primary|Body ｗeight|Change in body weight from baseline after 7-day repeated oral administration of OPC|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF||Kg||Standard Deviation|Mean
75618|NCT01050257|Secondary|Percentage of Participants With Influenza Symptoms|Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.|Days 1, 11, 15, 30|Intent-to-Treat population included all treated participants.||Percentage of participants|||Number
75619|NCT01050257|Secondary|Number of Participants With Viral Resistance|Nasal and Throat swabs were collected on Days 1, 4, 6, 11, 15 and 30 and were sent to a central laboratory for testing. Viral resistance was determined by phenotypic and genotypic testing.|30 days|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Participants|||Number
75620|NCT01050257|Secondary|Time to Resolution of Fever for Participants Who Had a Fever at Baseline|Fever was defined as a temperature of ≥ 37.8 C (degrees Celsius). Resolution of fever was a temperature ≤ 37.2 for at least 21.5 hours.|Baseline, Up to 30 Days|Participants from the Intent-to-Treat Infected population, all treated participants with confirmed influenza infection by culture or RT-PCR, who had a fever at Baseline.||Hours||95% Confidence Interval|Median
75621|NCT01050257|Secondary|Percentage of Participants Who Had a Fever During the Study|Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).|Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
75622|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4|Nasal and throat swabs were collected at Baseline and Day 4 and were sent to a central laboratory for analysis. Influenza Viral titers (amount of virus present) were determined by RT-PCR for Flu A and Flu B and were reported in log 10 copies/milliliter (mL). A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-Treat Infected population with data available for analysis. Only participants with positive influenza results are included.||log 10 copies/mL||Standard Deviation|Mean
75623|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Culture at Day 4|Nasal and throat swabs collected at Baseline and Day 4 were sent to a laboratory for analysis. Viral influenza titer (amount of virus present) was determined by culture. A log 10 median tissue culture infective dose (TCID50) > 0.5= Positive culture. A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-treat Influenza Infected population with data available for analysis. Only participants with positive influenza results are included.||log10 TCID50||Standard Deviation|Mean
75624|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
75625|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture=log10 median tissue culture infective dose (TCID50) > 0.5.|Days 1, 4, 6, 11, 15, 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
75626|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture or RT-PCR|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.||Percentage of participants|||Number
75627|NCT01050257|Secondary|Pharmacokinetics||Days 1, 3||12/2013||||
75628|NCT01050257|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death|"Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~On treatment = AEs that started between the day of first dose and within 2 days after the last dose. Off treatment = AEs that started more than 2 days after the last dose of study drug."|Up to 30 days|Safety population included all participants who received treatment and had at least one post-treatment safety assessment. One patient in the 100 mg group actually received 200 mg and is included in the 200 mg group for safety.||Partipants|||Number
75808|NCT01047839|Secondary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination||up to Month 7||||||
75634|NCT01050153|Secondary|TEG Parameters|"Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc).~The absolute SEMS of the sample can be calculated from MA as follows:~G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA."|Study day five.|||Kd/sc||Standard Error|Mean
75635|NCT01050153|Secondary|Platelet Count|Platelet count measured by CBC test|Study day five.|||* 10^3 platelets/µL||Standard Deviation|Mean
75636|NCT01050153|Secondary|International Normalized Ratio (INR)|Plasma based conventional coagulation testing parameters|Study day five.|||ratio||Standard Error|Mean
75637|NCT01050153|Secondary|TEG Parameters|"R is a reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing).~Rf is a difference in reaction time between Fragmin-active and Fragmin-neutralized samples.~Achievement of a certain clot strength K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm).~Angle or α measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation.~MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets."|Study day five.|||Minutes||Standard Error|Mean
75638|NCT01050153|Primary|Incidence of VTE|The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only)|Day 28 or discharge, whichever comes first.|||participants|||Number
75639|NCT01050153|Primary|Hypercoagulability|To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9.|Study day five.|The reason for having 21 participants in the Control group and 18 participants in the TEG-guided group is that 21 and 18 participants in the respective groups stayed five days or longer. Four participants (25-21) in the Control group and seven participants (25-18) in the TEG-guided group stayed less than five days.||participants|||Number
75640|NCT01050062|Secondary|Blood Pressure Normalised Rate|The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||percentage of participants|||Number
75641|NCT01050062|Secondary|Target Blood Pressure Achievement Rate|The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||Percentage of patients|||Number
75642|NCT01050062|Secondary|Diastolic Blood Pressure (DBP)|DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||mmHg||Standard Deviation|Mean
75643|NCT01050062|Secondary|Systolic Blood Pressure (SBP)|SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.||mmHg||Standard Deviation|Mean
75644|NCT01050062|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey||Patients|||Number
75645|NCT01049984|Secondary|Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater|"Site raters were asked: Considering your total clinical experience with the particular population, how ill is the patient at this time? Answers were based on a 0-7 scale, with 0=not assessed, 1= normal, not at all ill, and 7= among the most extremely ill of patients.~Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|Day 0 (baseline), Week 18|Modified intent to treat||participants|||Number
75646|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant|CGI is used by the participant to rate his/her total improvement during the study. Specifically, participants are asked to compare their condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).|18 weeks|Modified intent to treat||participants|||Number
75647|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater|"CGI is used by the site rater to rate participants total improvement during the study whether or not, in the investigators' judgment, it is due entirely to drug treatment. Specifically, site raters are asked to compare the participants condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).~Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|18 weeks|Modified intent to treat||participants|||Number
75690|NCT01049360|Secondary|Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1||Liters||Standard Error|Least Squares Mean
75648|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Part III – Motor Function|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, the third of which is reported in this outcome. Part III is a clinician's evaluation of motor function. Part III contains 14 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-56. Negative change from baseline values indicate improvement.~All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits"|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale III, and therefore that subscale was set as missing.||units on a scale||Standard Error|Least Squares Mean
75649|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Part II – Activities of Daily Living|The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. UPDRS contains four parts, the second of which is reported in this outcome. Part II is the participants' evaluation of the disease's impact on normal activities. Part II contains a total of 13 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-52. Negative change from baseline values indicate improvement.|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale II, and therefore that subscale was set as missing.||units on a scale||Standard Error|Least Squares Mean
75650|NCT01049984|Primary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Parts I, II and III|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson’s Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement.~All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits."|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment; therefore the total UPDRS for these participants was set as missing.||units on a scale||Standard Error|Least Squares Mean
75651|NCT01049945|Secondary|Overall Survival (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
75652|NCT01049945|Secondary|Progression Free Survival (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
75653|NCT01049945|Secondary|Time to Progression (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
75654|NCT01049945|Secondary|Duration of Response (Phase II)||Up to 2 years from study completion (6 years total)||10/2016||||
75655|NCT01049945|Primary|Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).|"Complete response (CR)~- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow~Near complete response (nCR) A CR, with the persistence of original monoclonal protein~Very good partial response (VGPR)~- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h~Partial response (PR)~≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.~a ≥50% decrease in the difference between involved and uninvolved FLC levels~or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline."|Up to 6 cycles of treatment|All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.||percentage of participants||95% Confidence Interval|Number
75656|NCT01049945|Primary|Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)|"The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:~Grade 2 neuropathy with pain~Any grade 3 Non-Hematologic toxicity~Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days.~Grade 4 neutropenia~Febrile neutropenia~Grade 4 thrombocytopenia~Grade 3 thrombocytopenia associated with bleeding~Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days.~We are reporting the results of this endpoint as the number of DLTs per dose level."|One cycle of treatment|All participants registered to the Phase I portion of this study were evaluable for this endpoint.||Dose Limiting Toxic Events|||Number
75668|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline – 12 months)were calculated by the software at the QLF threshold of 5%.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.||lesions/child||Standard Deviation|Mean
75657|NCT01049802|Secondary|NIH Stroke Scale|"A composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale~15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity~Items are graded on a 3 or 4 point ordinal scale; 0 equates no impairment~Scores range from 0 – 42. Higher scores indicate greater severity.~Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989):~Very Severe: >25~Severe: 15 – 24~Mild to Moderately Severe: 5 – 14~Mild: 1 – 5"|Screening, baseline, post treatment, 1 month, 6 months|1 data point missing from treatment arm at 6 month||units on a scale||Standard Deviation|Mean
75658|NCT01049802|Secondary|Chedoke Arm Assessment|A 7 point scale of motor recovery scored separately for arm. 7 is good motor recovery and 1 is no movement.|Screening, baseline, weekly, post treatment, 1 month, 6 months|1 data point is missing in treatment arm at 6 month post||units on a scale||Standard Deviation|Mean
75659|NCT01049802|Secondary|Stroke Impact Scale|"The SIS is a quality of life questionnaire designed for stroke survivors. It is a 59 item measure~8 domains assessed:~Strength (4 items)~Hand function (5 items)~ADL/IADL (10 items)~Mobility (9 items)~Communication (7 items)~Emotion (9 items)~Memory and thinking (7 items)~Participation/Role function (8 items)~Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item~Summative scores are generated for each domain, scores range from 0-100"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm a 6 months||units on a scale||Standard Deviation|Mean
75660|NCT01049802|Secondary|Action Research Arm Test|"The ARAT is a measure of upper limb dexterity and is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:~3: Performs test normally~2: Completes test, but takes abnormally long or has great difficulty~1: Performs test partially~0: Can perform no part of test Range is 0-57 with higher scores relating to better upper limb dexterity"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm at both 1 week and 6 month follow-up||units on a scale||Standard Deviation|Mean
75661|NCT01049802|Primary|Upper Extremity Fugl-Meyer Score|Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)|Baseline, post treatment, 1 month, 6 months|6 month outcome is the primary endpoint. 1 data point is missing from the treatment arm at 6 month follow up.||units on a scale||Standard Deviation|Mean
75662|NCT01049776|Secondary|To Describe the Clinical Toxicity Profile of Pazopanib in This Particular Patient Population||after the first 6 patients and quarterly||||||
75663|NCT01049776|Primary|Proportion of Non Small Cell Lung Cancer Participants With Disease Control (Complete Response+Partial Response+Stable Disease) Based on RECIST 1.0 Measured by CT or MRI|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesion, taking as reference the baseline sum of the longest diameter: Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum Longest Diameter since the treatment started|12 weeks|||Proportion of participants||95% Confidence Interval|Number
75664|NCT01049581|Secondary|Subscale on Cerebral Palsy Quality of Life Questionnaire for Children|This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years. It contains social , functioning, participation , emotional ,access, pain and disability, and family health components. Participation is the main component in this study. This sub score ranges from 0 to 81 , higher scores represent better participation|3months|||units on a scale||Standard Error|Mean
75665|NCT01049581|Secondary|Daily Living Subscale of Vineland Adaptive Behavior Scale|Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old. The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.|3 months|||units on a scale||Standard Deviation|Mean
75666|NCT01049581|Primary|Unit on Gross Motor Function Measure Scale (GMFM)|The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy|3 months|complete the study and examination||units on a scale||Standard Deviation|Mean
75667|NCT01049503|Secondary|Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used|The lesions’ progression was evaluated by the data from the examinations at baseline and after 12 months. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth).|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.||progressed lesions/child||Standard Deviation|Mean
75689|NCT01049373|Primary|Change in FFbH-R Between Screening and Week 15|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.~Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best)"|between screening and 15 weeks treatment|ITT||units on a scale||Standard Deviation|Mean
75669|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline – 12 months)were calculated by the software at the QLF threshold of 5%. A negative ∆F value indicates caries regression.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.||lesions/child||Standard Deviation|Mean
75670|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.|Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Buzalaf et al. (2009). From the trial participants in the fluoridated area, a convenience sample of 161 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.||µgF/g||Standard Deviation|Mean
75671|NCT01049503|Secondary|Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions’ progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.||regressed lesions/child||Standard Deviation|Mean
75672|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.||progressed lesions/child||Standard Deviation|Mean
75673|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.|Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Pessan et al. (2008). From the trial participants in the fluoridated area, a convenience sample of 47 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.||mmol/kg||Standard Deviation|Mean
75674|NCT01049373|Secondary|Number of ADRs|frequency of ADR with a probable or possible causal relationship|within 15 weeks treatment|||adverse reactions|||Number
75675|NCT01049373|Secondary|Number of Days With Incapability to Work||15 weeks treatment||||||
75676|NCT01049373|Secondary|Amount of Analgesics Used||15 weeks treatment||||||
75677|NCT01049373|Secondary|Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)||following 15 weeks treatment||||||
75678|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12) Ment||following 15 weeks treat||||||
75679|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12)||following 2 weeks treatment||||||
75680|NCT01049373|Secondary|Change in Oswestry Score||following 15 weeks treatment||||||
75681|NCT01049373|Secondary|Change in Oswestry Score||following 2 weeks treatment||||||
75682|NCT01049373|Secondary|Change in State of Health (BF-S)||following 15 weeks treatment||||||
75683|NCT01049373|Secondary|Change in State of Health (BF-S)||following 2 weeks treatment||||||
75684|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 15 weeks treatment||||||
75685|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 2 weeks treatment||||||
75686|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.~Difference between screening and 15 weeks in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 15 weeks treatment|Only patients with assessable values at present time point were analyzed.||units on a scale||Standard Deviation|Mean
75687|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.~Difference between V1 minus V-1 in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 2 weeks treatment|Only patients with assessable values at present time point were analyzed.||units on a scale||Standard Deviation|Mean
75688|NCT01049373|Secondary|Change in FFbH-R Between Screening and 2 Weeks|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.~Change in FFbH-R between screening and 2 weeks Scale ranges from 0 (=worst) to 100(=best)"|between screening and 2 weeks treatment|ITT||units on a scale||Standard Deviation|Mean
75691|NCT01049360|Secondary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1||Liters||Standard Error|Least Squares Mean
75692|NCT01049360|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1||Liters||Standard Error|Least Squares Mean
75693|NCT01049308|Secondary|Medication Adherence|"To capture both overtaking and undertaking medication, a delta was determined for each medication by computing the absolute difference between the number of pills taken and the number prescribed over the 30-day period. The delta values for each medication were summed for each individual subject, divided by the total number of pills prescribed, subtracted from 1, and finally multiplied by 100 to obtain an adherence score expressed as a percentage."|30 days|||percentage of adherence||95% Confidence Interval|Mean
75694|NCT01049308|Primary|SLUMS Scores|SLUMS (Saint Louis University Mental Status) exam is a validated screening test for cognitive impairment (CI) consisting of 30-point interview scale. SLUMS is considered positive for mild CI if the score is <27 in a person with a high school diploma or <25 in a person who did not complete high school. SLUMS screening is considered positive for severe impairment consistent with dementia if the score is <21 for persons with a high school diploma and <20 for persons who did not complete high school.|baseline collection|||scores on a scale||Standard Deviation|Mean
75695|NCT01049243|Secondary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.||Baseline to 14 days||||||
75696|NCT01049243|Primary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.|Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.|Baseline to 3 days|||Scores on a scale||Standard Deviation|Mean
75697|NCT01049217|Secondary|Diagnostic Neuropathy Assessment||Screening|Data were not collected since this was a screening tool for investigators and there was no analysis planned for this measure.|||||
75698|NCT01049217|Other Pre-specified|Number of Participants With Response to Patient Health Questionnaire–8 (PHQ-8)|PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated “Over past 2 weeks, how often bothered by any of following problems?”: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.|Screening|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.||participants|||Number
75699|NCT01049217|Other Pre-specified|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Screening, Post-Baseline (Week 4 up to Week 17)|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||participants|||Number
75700|NCT01049217|Other Pre-specified|Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria|MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.|Screening|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
75701|NCT01049217|Other Pre-specified|Number of Participants With Neurological Examination Findings|A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities [LE], right and left first metatarsal joint position sense, and vibration sensation [vibration is felt for < 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, > 10 seconds = normal]).|Screening|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.||participants|||Number
75702|NCT01049217|Other Pre-specified|Sitting Heart Rate||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||beats per minute (bpm)||Standard Deviation|Mean
75703|NCT01049217|Other Pre-specified|Sitting Systolic and Diastolic Blood Pressure|Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.|Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
83764|NCT00967551|Primary|Proportion of Children of Diarrhea Episodes|Number of children with diarrhea divided by the number of children in the group|6 months|All children enrolled||percentage of participants|||Number
75704|NCT01049217|Other Pre-specified|Body Weight||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.||kilogram||Standard Deviation|Mean
75705|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities.|Screening, Week 8, 17|Safety population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group.||participants|||Number
75706|NCT01049217|Other Pre-specified|Number of Participants With Positive Serum and Urine Pregnancy|Serum pregnancy test (regardless of childbearing potential) and urine pregnancy test for all female participants were performed.|Screening for serum pregnancy test, Week 1 for urine pregnancy test|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
75707|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.|Screening up to Week 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. N (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
75708|NCT01049217|Other Pre-specified|Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.||participants|||Number
75709|NCT01049217|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
75710|NCT01049217|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively.||hours||Standard Deviation|Mean
75711|NCT01049217|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded “Yes/No” to Question 1: Are you currently employed (working for pay)? are reported.|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.||participants|||Number
75712|NCT01049217|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75738|NCT01048723|Secondary|Number of Participants With Pathological Response|We planned to determine pathological response in terms of tumor necrosis and apoptosis assessed on the resected specimens after 2 weeks of RAD001 therapy. Percent necrosis was to be reported based on the routine H and E staining. In addition to cleaved PARP analysis, TUNEL assays were to be performed judging the amount of apoptosis in the specimens after treatment. Our planned analysis was for 40 participants.|Post the 2 week treatment||||||
75713|NCT01049217|Secondary|Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75714|NCT01049217|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||participants|||Number
75715|NCT01049217|Secondary|Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75716|NCT01049217|Secondary|Percentage Day Time Above Sedentary Level|Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (>) 200 activity counts per minute divided by total number of epochs during the “day” (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||percentage of day time||Standard Error|Least Squares Mean
75717|NCT01049217|Secondary|Total Activity Counts|"Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method."|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||activity counts per day||Standard Error|Least Squares Mean
75718|NCT01049217|Secondary|Sleep Efficiency|Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||Percent time between sleep onset and end||Standard Error|Least Squares Mean
75719|NCT01049217|Secondary|Sleep Fragmentation Index (SFI)|SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||percentage of immobile bouts||Standard Error|Least Squares Mean
75761|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||12 months||||||
75720|NCT01049217|Secondary|Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)|Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.||minutes||Standard Error|Least Squares Mean
75721|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75722|NCT01049217|Secondary|Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours [hrs], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||participants|||Number
75723|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75724|NCT01049217|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)|BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.|Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75725|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current (“right now”) HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75726|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.||units on a scale||Standard Deviation|Mean
75727|NCT01049217|Secondary|Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)|The CGIC scale measures a physician’s global impression of a participant’s clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
75728|NCT01049217|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
75729|NCT01049217|Primary|Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).|Baseline, Endpoint (up to Week 16)|Intent to Treat (ITT) population: all randomized participants who took at least 1 dose of study drug. Imputation: mBOCF, baseline data was carried forward for participants who discontinued due to adverse events or had no post-baseline observations; otherwise last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
75730|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|24 weeks|||mL/100 mL/min||Standard Deviation|Mean
75731|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|12 weeks|||mL/100 mL/min||Standard Deviation|Mean
75732|NCT01048944|Primary|Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence|"Changes in log from baseline in the widely used Shiffman-Jarvik Withdrawal craving and psychological symptom scores through 66 days of abstinence. Post-quit changes were assessed at days 3, 24, 45, and 66 of abstinence. The maximal range of value raw for craving is from 5 = (no craving) to 47 (maximally strong craving), while that for psychological symptoms is from 5 (no symptoms) to 60 (maximally intense symptoms of across multiple symptoms). Because the subtraction of logs is equivalent to the ratio of the two scores, a difference in logs (base 10) with a value of 1 is equal to an increase by a factor of 10, while a value of 0 is no change, and values of less than 0 are decreases below baseline values."|Changes in log withdrawal symptoms from baseline through 66 days of abstinence|Analysis population included only those individuals who complied fully with study requirements through 67 days of abstinence.||log (base 10) units on a scale||Standard Error|Mean
75733|NCT01048944|Primary|Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.|Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second [cps]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power [microvolts squared] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline.|Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit|For the currently reported analyses, only individuals complying with the study requirements, including biochemically verified smoking abstinence, were assessed. Future analyses will include individuals who complied to certain critical endpoints.||Change in log EEG [microvolts squared]||Standard Error|Mean
75734|NCT01048879|Primary|Oseltamivir Carboxylate Removal by ECMO|Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.|12 hours|All of the patients that received ECMO were included. Patients receiving CVVHD Alone did not receive ECMO and were not included.||percent change in concentration||Standard Deviation|Mean
75735|NCT01048879|Primary|Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance|Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).|12 hours|One patient in the CVVHD Alone group was excluded from the analysis because not enough data points were available for pharmacokinetic modeling.||mL/min||Standard Deviation|Mean
75736|NCT01048788|Primary|Body Weight|Changes in body weight from baseline at the end of administration|Baseline, Day 14 or end of administration|||Kg||Standard Deviation|Mean
75737|NCT01048723|Secondary|Number of Participants With Memory CD8 T Cell Enhanced Production|Memory CD8 T cell enhanced production as determined by fluorescence activated cell sorter (FACS) analysis on blood and tumor core biopsy specimens taken before and after therapy with RAD001. Our planned analysis was for 40 participants.|Pre and Post the 2 week treatment||||||
75762|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||6 months||||||
75739|NCT01048723|Secondary|PD Markers (p70S6K, S6-RP, P-AKT, Cleaved PARP and PCNA)|Quantitative in vivo and ex vivo assessments of PD markers (p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA) were to be normalized within the same sample. The extent of inhibition is defined as the fractional inhibition in each patient calculated as [(PreRx normalized PD marker – PostRx normalized PD marker) / PreRx normalized PD marker] x 100. Same definition would apply to each of these markers. Our planned analysis was for 40 participants.|Post the 2 week treatment||||||
75740|NCT01048723|Primary|Pharmacodynamics (PD) Markers|PD markers of RAD001 on downstream signaling pathways in patients with sarcomas: p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA by Western blot, quantitative multiplex assays and immunohistochemical studies measured pre and post the 2 week treatment of RAD001. Patients were to be separated into two groups, responders and non responders based on PD results and downstream up regulation of the referenced pathways. Mean fractional inhibition of each PD marker for the responding and non-responding groups were to be calculated. Our planned analysis was for 40 participants.|Pre and post the 2 week treatment||||||
75741|NCT01048697|Primary|Total Clearance of Ethambutol||Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours)|||L/h||Standard Deviation|Mean
75742|NCT01048671|Secondary|Number of Participants With at Least One Adverse Event|An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor’s product whether or not related to the use of the product.|Up to 25 months after start of raltegravir treatment|Participants enrolled and not excluded for a protocol violation were included in the analysis.||Participants|||Number
75743|NCT01048671|Primary|Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||cells/mm^3||95% Confidence Interval|Mean
75744|NCT01048671|Primary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||cells/mm^3||95% Confidence Interval|Mean
75745|NCT01048671|Primary|Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||Percentage of participants||95% Confidence Interval|Number
75746|NCT01048671|Primary|Percentage of Participants Responding to Treatment: All Treated Participants|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.||Percentage of participants||95% Confidence Interval|Number
75747|NCT01048671|Primary|Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.|Up to 25 months after start of raltegravir treatment|Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.||Percentage of participants|||Number
75748|NCT01048606|Secondary|Physical Capacity: 3 Tests From the Senior Fitness Test (Chair Stand Test, Chair Sit-and-Reach Test, Back Scratch Test) + Handgrip Strength Test (Lafayette Hand Dynamometer, Indiana)||0, 6 and 12 months||||||
75749|NCT01048606|Secondary|Maximal Oxygen Uptake Measured Using a Continuous, Incremental Protocol (Balke Modified Protocol) on a Treadmill With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA).||0 and 12 months||||||
75750|NCT01048606|Secondary|Metabolic Rate at Rest: During 30 Minutes With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA) After a 12-hour Fast, in the Early Morning.||0, 6 and 12 months||||||
75751|NCT01048606|Secondary|Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method||0, 6 and 12 months||||||
75752|NCT01048606|Secondary|Physical Activity Level: Physical Activity Scale for the Elderly (PASE)||0, 6 and 12 months||||||
75753|NCT01048606|Secondary|Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval)||0, 6 and 12 months||||||
75754|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||12 months||||||
75755|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||6 months||||||
75756|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||12 months||||||
75757|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||6 months||||||
75758|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||12 months||||||
75759|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||6 months||||||
75760|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||Baseline||||||
75763|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||12 months||||||
75783|NCT01048424|Secondary|Change in Sleep Quality|The Pittsburgh Sleep Quality Index. A global sleep quality score derived from the PSQI can be used to index overall quality of sleep over the prior one-week period. Global sleep quality scores are continuous (range 0-21), with high scores reflecting poor sleep quality.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
75784|NCT01048424|Secondary|Change in Perceived Stress|Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
75785|NCT01048424|Secondary|Change in Depression Symptoms|Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
75786|NCT01048424|Secondary|Change in Anxiety Symptoms|Hospital Anxiety and Depression Scale. Anxiety Subscale range from 0 to 21, with scores of less than 8 indicative of absence of anxiety symptoms, 8 or above suggesting anxiety symptoms, and 12 or above suggesting generalized anxiety disorder.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
75787|NCT01048424|Secondary|Change in Overactive Bladder Symptoms|The Overactive Bladder Questionnaire (OAB-Q). 0- to 100-point scale. Higher scores on the OAB-Q indicate greater bothersomeness and impact of overactive bladder symptoms.|Baseline to 6 weeks|||Score on a Scale||Standard Deviation|Mean
75788|NCT01048424|Secondary|Percent Change in Daytime Voiding Frequency.|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks|||Percent Change||Standard Deviation|Mean
75789|NCT01048424|Secondary|Percent Change in Any Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks|||Percent Change||Standard Deviation|Mean
75790|NCT01048424|Primary|Percent Change in Urgency Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|baseline to 6 weeks|||Percent Change||Standard Deviation|Mean
75791|NCT01048333|Secondary|Adverse Events|Number of participants with at least 1 AE.|At baseline and at each day of treatment|||Participants|||Number
75792|NCT01048333|Secondary|Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1|Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1|Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose|||Percentage of Participants|||Number
75793|NCT01048333|Secondary|Average FEV1 During 120 Minutes Post Dose|Average FEV1 during 120 minutes post dose, change versus pre dose FEV1|Pre dose and 120 minutes post dose|||percentage change||95% Confidence Interval|Geometric Mean
75794|NCT01048333|Secondary|Average FEV1 During the First 15 Minutes Post Dose|Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1|Pre dose and 15 minutes post dose|||percentage change||95% Confidence Interval|Geometric Mean
75795|NCT01048333|Primary|FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose|FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1|Pre-dose and 5 minutes post-dose|||percentage change||95% Confidence Interval|Geometric Mean
75796|NCT01048125|Primary|Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.||2 years|Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.|||||
75797|NCT01048099|Primary|Part II: Objective Response Rate of Pertuzumab Therapy|The percentage of patients with HER2 activation (no overexpression) as identified by the PRO Onc Assay who experience an objective benefit from treatment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes patients with only HER2 activation (no overexpression) as detected by the PRO Onc Assay||percentage of participants|||Number
75798|NCT01048099|Primary|Part II: Objective Response Rate of Trastuzumab Therapy|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression as identified by the PRO Onc Assay.|18 months|Includes patients with HER2 overexpression detected by the PRO Onc Assay||percentage of participants|||Number
75799|NCT01048099|Secondary|Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens|Percentage of HER2-negative MBC patients (identified by FISH testing) having CTCs present in blood specimens.|12 months|Includes all patients with blood drawn and analyzed for CTCs||percentage of participants|||Number
75800|NCT01048099|Primary|Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)|The percentage of HER2-negative metastatic breast cancer (MBC) patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression/activation as detected by PRO Onc Assay.|18 months|||percentage of participants|||Number
75801|NCT01048099|Secondary|Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay|Includes patients with HER2-negative metastatic breast cancer (MBC) as determined by FISH testing.|12 months|||participants|||Number
75802|NCT01047839|Secondary|SCRs and GMTs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups||at Day 56 and Month 7||||||
75803|NCT01047839|Secondary|GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7||at Day 56 and Month 7||||||
75804|NCT01047839|Secondary|SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)||at Day 56 and Month 7||||||
75805|NCT01047839|Secondary|Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and up to Month 7||||||
75809|NCT01047839|Primary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination|Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.|until Day 56|||percentage of participants||95% Confidence Interval|Number
75810|NCT01047709|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of presumed sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The relative treatment effect on AHI using GEE modeling.|1 day|||events/hr||Inter-Quartile Range|Median
75811|NCT01047553|Secondary|St George’s Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
75812|NCT01047553|Secondary|Use of SABA (Salbutamol) as Reliever Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Times/Day||Standard Deviation|Mean
75813|NCT01047553|Secondary|Number of COPD Exacerbations Over the Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment was presented here.|Daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||number of exacerbations|||Number
75814|NCT01047553|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
75815|NCT01047553|Secondary|Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
75816|NCT01047553|Secondary|Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Mean
75817|NCT01047553|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||units on a scale||Standard Deviation|Median
75818|NCT01047553|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Liter/minute (L/min)||Standard Deviation|Mean
75819|NCT01047553|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Liter/minute (L/min)||Standard Deviation|Mean
75820|NCT01047553|Secondary|Forced Vital Capacity (FVC)|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||Percentage of baseline||Full Range|Geometric Mean
75821|NCT01047553|Secondary|Forced Expiratory Volume in One Second (FEV1)|The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).||percentage of baseline||Full Range|Geometric Mean
75822|NCT01047553|Primary|ECG Variables RR Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
75823|NCT01047553|Primary|ECG Variables QTcF Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
75824|NCT01047553|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
75825|NCT01047553|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||milisecond||Standard Deviation|Mean
75826|NCT01047553|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||beats/min||Standard Deviation|Mean
75827|NCT01047553|Primary|Vital Signs - Pulse Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||beats/minute||Standard Deviation|Mean
75828|NCT01047553|Primary|Vital Signs- Sitting DBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mmHg||Standard Deviation|Mean
75829|NCT01047553|Primary|Vital Signs- Sitting SBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mmHg||Standard Deviation|Mean
75830|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dl||Standard Deviation|Mean
75831|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Protein|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||g/dl||Standard Deviation|Mean
75832|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Albumin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||g/dl||Standard Deviation|Mean
75833|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S- Calcium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dl||Standard Deviation|Mean
75834|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Potassium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mEq/L||Standard Deviation|Mean
75835|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Sodium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mEq/l||Standard Deviation|Mean
75836|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dL||Standard Deviation|Mean
75837|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Creatinine|Change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||mg/dL||Standard Deviation|Mean
75838|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||U/l||Standard Deviation|Mean
76402|NCT01040130|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
75839|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||U/l||Standard Deviation|Mean
75840|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||U/l||Standard Deviation|Mean
75841|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Neutrophil||Standard Deviation|Mean
75842|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Monocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Monocyte||Standard Deviation|Mean
75843|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Lymphocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Lymphocyte||Standard Deviation|Mean
75844|NCT01047553|Primary|Clinical Laboratory Test: Haematology Basophil|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Basophil||Standard Deviation|Mean
75845|NCT01047553|Primary|Clinical Laboratory Test: Haematology Eosinophils|Change from baseline|baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||percentage of Eosinophil||Standard Deviation|Mean
75846|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Platelet Count|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||Platelet Count x10000/μl||Standard Deviation|Mean
75847|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Leucocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||leukocyte count/µL||Standard Deviation|Mean
75848|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||g/dL||Standard Deviation|Mean
75849|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.||erythrocytes counts x10000/μl||Standard Deviation|Mean
75850|NCT01047527|Primary|Week 24 Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|24-week|This analysis was planned to replicate the previous study (Schnoll et al., 2010; Annals of Internal Medicine).||participants|||Number
75851|NCT01047527|Primary|Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|52-week|The primary objective of this study was to examine the benefits in terms of cessation of 52-weeks of treatment compared to 8 or 24 weeks.||participants|||Number
75852|NCT01047475|Primary|The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)|The primary efficacy analysis, the incidence of best overall response during the study period, was based on the Fisher’s exact test for the binary response that was used to test for the differences in the treatment efficacy between MB-6 and Placebo.|16 weeks|||percentage of Best overall Response||95% Confidence Interval|Median
75853|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose|Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication|12 h (hours) after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h||Percent reduction||Full Range|Median
75854|NCT01047436|Primary|Time for Parasite Count to Fall by 50% PCT(50)|The time taken for the parasite count to fall 50% from baseline|3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h|||hours||Standard Deviation|Mean
75855|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose|Reduction in parasitaemia from baseline at 24 h after the first dose of study medication|24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h||Percent reduction||Full Range|Median
75856|NCT01047436|Primary|Time for Parasite Count to Fall by 90% PCT(90)|The time taken for the parasite count to fall 90% from baseline|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h|||hours||Standard Deviation|Mean
75857|NCT01047436|Secondary|Parasite Clearance Time|Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h|||Hours||Standard Deviation|Mean
96363|NCT00845676|Secondary|Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype|Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR|24 weeks||||||
75858|NCT01047436|Primary|Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose||24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h (hours) or 24 h after start of treatment.||participants|||Number
75859|NCT01047358|Secondary|Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)|The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of the study, average of 5.6 months|Efficacy Analysis Set.||Percentage of Participants|||Number
75860|NCT01047358|Secondary|Time-to-Progression (Early Breast Cancer)|Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.|At the end of the study, average of 5.6 months|This outcome was planned to be analyzed in participants with early breast cancer in the efficacy analysis set. However, the analysis was not performed because the data of time-to-progression was not captured in the CRF.|||||
75861|NCT01047358|Secondary|Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)|The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant’s case report form (CRF).|At the end of the study, average of 5.6 months.|Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available.||Percentage of Participants|||Number
75862|NCT01047358|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.|From the first dose of Aromasin through the end of the study for an average of 5.6 months|Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once.||Percentage of Participants|||Number
75863|NCT01047345|Other Pre-specified|Percentage of Participants Who Experience an SAE- Extension Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to Month 7 - Extension Study|All participants who received at least 1 vaccination in Extension Study and had available follow-up data.||Percentage of Participants|||Number
75864|NCT01047345|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7; End of Base Study)|Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.||Percentage of Participants||95% Confidence Interval|Number
75865|NCT01047345|Primary|Percentage of Participants Who Experience a Severe Injection-site AE – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
75866|NCT01047345|Primary|Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study– Base Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” is defined as a vaccine-related SAE.|Up to 7 months - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
75867|NCT01047345|Primary|Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination – Base Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
75913|NCT01047189|Primary|Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne|Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap|12 weeks|All patients were analyzed up to end of treatment or last visit.||Percent of doses||Full Range|Median
75868|NCT01047345|Primary|Percentage of Participants Who Experience a Systemic AE – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
75869|NCT01047345|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) – Base Study|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available temperature data.||Percentage of Participants|||Number
75870|NCT01047345|Primary|Percentage of Participants Who Experience an Injection-site Adverse Event (AE) – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.||Percentage of Participants|||Number
75871|NCT01047306|Other Pre-specified|Change From Baseline in Phosphorylated Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF phosphorylated tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that phosphorylated tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||picograms/milliliter||Standard Deviation|Mean
75872|NCT01047306|Other Pre-specified|Change From Baseline in Total Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that total tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||picograms/milliliter||Standard Deviation|Mean
75873|NCT01047306|Secondary|Change From Baseline in The Total Sleep Disturbance (TSD) Score of The Children’s Sleep Habits Questionnaire (CSHQ)|The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. The questionnaire was designed for children aged 4 to 12 years. Parents were asked to think of a recent “typical” week of their child’s sleep and to indicate how often sleep disturbance behaviors occurred. A 3-point scale was used for rating: “usually” if the sleep behavior occurs 5 to 7 times per week, “sometimes” for 2 to 4 times per week, and “rarely” for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||units on a scale||Standard Deviation|Mean
75874|NCT01047306|Secondary|Change From Baseline in The Infant Toddler Quality of Life Questionnaire (ITQoL) Growth And Development Subscale|The ITQoL Questionnaire is a generic, validated health status measure for children aged 2 months up to 5 years, including items and scales to measure aspects of physical functioning, development, pain, mood, behavior, general health, and impact on parents. In this study the ITQoL was also administered to patients who were developmentally functioning at or below the age of years. Growth and development is one of 12 health concepts measured by ITQoL. Transformed scores for all subscales range from 0 to 100, with a higher score indicating better health. A positive value indicates improvement.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||units on a scale||Standard Deviation|Mean
75875|NCT01047306|Secondary|"Number of Participants With Somewhat or Much Worse Change in Health as Assessed by The Child Health Questionnaire Parent Form 50 (CHQ-PF50)"|The parent form, CHQ-PF50, is designed to measure the physical and psychosocial well-being of children 5 years and older. In this trial it was used to assess the health of children 5 to 18 years of age. It consists of 13 health concepts including 11 multi-item and 2 single-item scales: physical function, role/social-emotional/behavioral, role/social-physical, bodily pain, general behavior, mental health, self-esteem, general health perceptions, change in health, parental impact-emotional, parental impact-time, family activities, and family cohesion. The parental impact scales capture the amount of emotional distress and time limitation experienced by the parent due to the child’s physical health, emotional well-being, attention/learning abilities, ability to get along with others, and general behavior. The Change in Health section assesses changes in health over the previous year.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||participants|||Number
75876|NCT01047306|Post-Hoc|Change From Baseline in Spleen Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Spleen volume was assessed via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||milliliters||Standard Deviation|Mean
75877|NCT01047306|Post-Hoc|Change From Baseline in Liver Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Liver volume was obtained via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||milliliters||Standard Deviation|Mean
75878|NCT01047306|Post-Hoc|Change From Baseline in The Ratio of Mitral Valve Early Inflow Velocity (E) to Late Inflow Velocity (A)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Blood flow through the mitral valve is measured during one heartbeat.The E/A ratio measures the relationship between early (E) and late (A) inflow velocity by dividing E by A. A positive value indicates that either early flow through the mitral valve (E) increased or late flow through the valve (A) decreased.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||quotient of E/A||Standard Deviation|Mean
75879|NCT01047306|Post-Hoc|Change From Baseline in Tricuspid Valve Regurgitant Velocity|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Backwards blood flow through the tricuspid valve is measured during one heartbeat. A negative value indicates decreased velocity.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||meters/second||Standard Deviation|Mean
75880|NCT01047306|Post-Hoc|Percent of Participants With Trace Regurgitation as Assessed by ECG|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Regurgitation indicates that blood flows backwards through the valve.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75881|NCT01047306|Post-Hoc|Percent of Participants With Thickened Heart Valves as Assessed by Echocardiography (ECG)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75882|NCT01047306|Secondary|Percent of Participants With Profound Hearing Loss, as Assessed by the Auditory Brainstem Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Profound hearing loss: 91+ decibels hearing level (dBHL).|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||percentage of participants|||Number
75883|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at End of Study, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
75884|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 12 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
96364|NCT00845676|Secondary|Safety and Tolerability of Treatment|Number of participants with treatment-associated problems|48 weeks||||||
75885|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 6 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
75886|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at Baseline, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||participants|||Number
75887|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75888|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75889|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75914|NCT01046903|Other Pre-specified|Number of Participants With Hematoma|Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75915|NCT01046903|Other Pre-specified|Number of Participants Compliant With the Treatment|Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis.|Baseline up to Week 5|Data was collected but not statistically summarized for analysis.||Participants|||Number
75919|NCT01046903|Other Pre-specified|Participant's Global Evaluation of Treatment|Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75890|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75891|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75892|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75893|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75894|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75916|NCT01046903|Other Pre-specified|Administration Schedule of Treatment|Administration schedule for Fragmin in major orthopedic surgery Included was categorized as; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75917|NCT01046903|Primary|Physician's Assessment of Efficacy of Treatment|Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Full Analysis Set (FAS) included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75895|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at End of Study|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75896|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 12 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75897|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 6 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75898|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at Baseline|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.||percentage of participants|||Number
75899|NCT01047306|Secondary|Change From Baseline in The Total Disability Score (TDS) of The Four Point Scoring System (FPSS)|The FPSS is an MPS III-specific disability assessment that evaluates motor function, expressive language, and cognitive function on a 0- to 3- point scale and can be used for individuals of all ages. A score of 3 points is assigned for normal function, 2 points for beginning of regression, 1 point for severe level of regression, and 0 points for lost skills. The total disability score (TDS) is the average of the motor function, speech, and cognitive function scores (range: 0, 3). The scoring is based on the parent’s response to a detailed questionnaire that covers several aspects of the disease. A positive value indicates improvement in function.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||units on a scale||Standard Deviation|Mean
75900|NCT01047306|Secondary|Change From Baseline Values in Gray Matter Volume Assessed by Brain Magnetic Resonance Imaging (MRI)|Total brain cortical gray matter volume was determined by analysis of brain MRI. The analysis was performed using “Freesurfer” software, which provides completely automated parcellation of the brain cortex and subcortical structures. In some cases, manual adjustments were necessary in cases of intensity normalization failure, resulting in erroneous white matter segmentation. A negative value indicates that gray matter volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||milliliters||Standard Deviation|Mean
75901|NCT01047306|Other Pre-specified|Change From Baseline in Urine Glycosaminoglycan (GAG) Levels|Urine GAG was measured by a dye binding assay. A negative value indicates that GAG levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||mg GAG/mmol creatinine||Standard Deviation|Mean
75918|NCT01046903|Other Pre-specified|Physician's Assessment of Tolerability of Treatment|Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75902|NCT01047306|Primary|Change From Baseline in VABS-II Overall DQ Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||percentage of chronological age||Standard Deviation|Mean
75903|NCT01047306|Primary|Change From Baseline in Vineland Adaptive Behavior Scales-II (VABS-II) Age-equivalent Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The mean age-equivalent score is obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills (range: 0, unbound). A positive value indicates improvement in health and cognition|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||months||Standard Deviation|Mean
75904|NCT01047306|Primary|Change From Baseline in BSID-III/KABC-II Developmental Quotient (DQ) Scores|The determination of whether a patient received BSID­III was based on an algorithm that includes the patient's calendar age and VABS­II age ­equivalent score (See Outcome 1). The BSID­III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC­II is an individually administered measure of processing and reasoning abilities. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID­III DQ score is based on the cognitive domain. The DQ score for KABC­II is calculated from the average non­verbal age-equivalent score. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||percentage of chronological age||Standard Deviation|Mean
75905|NCT01047306|Primary|Change From Baseline in Bayley Scales of Infant Development-III/Kaufman Assessment Battery for Children-II (BSID-III/KABC-II) Age-Equivalent Scores|Children 1 year-42 months were assessed by the BSID­III; those >42 months and with a developmental age of >42 months by the Vineland Adaptive Behavior Scales­II (VABS­II) were evaluated with the KABC­II. For children >42 months, but <42 months in developmental age, and those unable to complete at least 3 cognitive KABC­II subtests, the BSID­III was used. The BSID­III is a series of measurements to assess the motor, language, and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC­II is an individually administered measure of processing/reasoning abilities. Raw scores were converted to age­ equivalent scores to measure ability, skill, and knowledge, expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound ). A positive value indicates improvement. The BSID­III and KABC­II age­ equivalent scores were based on the cognitive domain and average non-verbal age-equivalent score, respectively.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.||months||Standard Deviation|Mean
75906|NCT01047241|Primary|Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine||Time=5-60 min after administration of investigational medicinal product|||minutes||Standard Deviation|Mean
75907|NCT01047241|Primary|Bioavailability of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product|||percentage bioavailable||Standard Error|Mean
75908|NCT01047241|Secondary|Acceptance of Intranasal Administration|Asking the children (parents for preverbal children) if they would like to receive this treatment again in a similar situation rather than analgesic suppositories, tablets, oral solutions, or injections?|Immediately after the procedure|||percentage of participants|||Number
75909|NCT01047241|Secondary|Sedation Score (UMSS)|"University of Michigan Sedation Score (UMSS) (0-4, 0 awake and alert, 4 unarousable)"|Time= 0-70 min. after drug administration|||units on a scale||Full Range|Median
75910|NCT01047241|Primary|Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product|||mcg/L||Standard Deviation|Mean
75911|NCT01047241|Primary|Procedural Pain Intensity Score|Children <5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 5 years but < 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).|Pain assessment during painful medical procedure|||units on a scale||Inter-Quartile Range|Median
75912|NCT01047189|Secondary|The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count||Baseline to 12 weeks|All patients were analyzed up to end of treatment or last visit.||percentage of lesions||95% Confidence Interval|Mean
75945|NCT01046396|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire at Week 3|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)||participants|||Number
75920|NCT01046903|Other Pre-specified|Number of Participants With Bleeding|Major bleeding: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram/litre (g/L) (2 g/decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor bleeding was defined as bleeding that did not meet the definition of major bleeding.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75921|NCT01046903|Other Pre-specified|Number of Participants With Thromboembolism|Thromboembolism is the formation of blood clot in the blood vessels due to an embolus (a detached intravascular mass capable of clogging arterial capillary beds at a site far from its origin).|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75922|NCT01046903|Other Pre-specified|Number of Participants With Risk Factors|Risk factors evaluated for vascular thromboembolism (VTE) were age (above 40 years, but age was not a strong risk factor as a prediction of potential VTE episode), gender (primarily females but males after 65 years also influenced VTE episode), obesity, pregnancy, liver disease, kidney disease, hormone therapy, immobilization, previous surgery, concomitant malignant disease, positive family history, varicose veins, smoking, chemotherapy, catheter in vein, Heart Failure III New York Heart Association (NYHA) and Heart Failure IV NYHA.|Baseline|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75923|NCT01046903|Other Pre-specified|Participant's Dosage Regimen|Approved dosage regimens for Fragmin in major orthopedic surgery included; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.||Participants|||Number
75924|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|12 months post procedure|One subject was lost to follow-up following the procedure. 2 subjects were lost to follow-up after the 30 day visit. 2 subjects were lost to follow-up after the 3 month visit. 3 subjects were lost to follow-up following the 6 month visit. 4 subjects were lost to follow-up after the 9 month visit and 2 subjects missed the 12 month visit.||percentage of ears|Participants|95% Confidence Interval|Number
75925|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|9 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two subjects were lost to follow-up after the 3 month visit. Three additional subjects were lost to follow-up following the 6 month visit and one subject missed the 9 month visit.||percentage of ears|Participants|95% Confidence Interval|Number
75926|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|6 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two additional subjects were lost to follow-up after the 3 month visit and two subject missed the 3 month visit.||percentage of ears|Participants|95% Confidence Interval|Number
75927|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|3 months|One subject was lost to follow-up immediately following the procedure. Two additional subjects were lost to follow-up after the 30 day visit and one subject missed the 30 day visit.||percentage of ears|Participants|95% Confidence Interval|Number
75928|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|30 days|One subject was lost to follow-up immediately following the procedure.||percentage of ears|Participants|95% Confidence Interval|Number
75929|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|9 Months|3 subjects lost to follow-up after 6 mo visit. 1 subject missed 9 mo visit. 2 subjects lost to follow-up after 3 mo visit. 2 subjects lost to follow-up after 30 day visit. 1 subject lost to follow-up following procedure. Thus, only 3 ears (= 3 participants) of 16 participants returning at 9 mos had unextruded tubes for assessment of patency.||percentage of tubes|Participants|95% Confidence Interval|Number
75930|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|6 months|Two subjects lost to follow-up after 3 month visit. Two subjects missed 6 month visit. Two subjects lost to follow-up after 30 day visit. One subject lost to follow-up immediately following procedure. Thus, only 13 ears (= 9 participants) of 18 participants returning at 6 months had unextruded tubes for assessment of patency.||percentage of tubes|Participants|95% Confidence Interval|Number
75931|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|3 months|Two subjects were lost to follow-up after the 30 day visit and one subject missed the 3 month visit. One subject was lost to follow-up immediately following the procedure. Thus, only 28 ears of 21 participants had unextruded tubes for assessment of tube patency.||percentage of tubes|Participants|95% Confidence Interval|Number
75932|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|30 days|One subject (one ear) was lost to follow-up immediately following the procedure.||percentage of tubes|Participants|95% Confidence Interval|Number
75933|NCT01046877|Secondary|Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure||12 months|Over the course of 12 months, a total of 17 subjects (25 ears) were assessed at varying follow-up time points as having had tubes extruded. Ears analyzed included those for which a tube was observed to extrude at any follow-up visit and ears that completed the 12 month visit.||percentage of tubes|Participants|95% Confidence Interval|Number
75934|NCT01046877|Primary|Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.|TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.|Procedural|One subject was missing data on intraprocedural adverse events and is excluded from this analysis.||percentage of ears|Participants|95% Confidence Interval|Number
75935|NCT01046695|Primary|Mean Pain Score|Pain was measured by using the Visual Analog Scale (VAS) with a range from 1-10; with 0 being no pain and 10 being severe pain. Pain scores were measured from hour 1 to hour 48 for each patient. Some scores were missed when patients were asleep. In these cases, the previous score was used.|hour 1 to hour 48 after awakening from video-assisted thoracic surgery|||units on a scale||Standard Deviation|Mean
75936|NCT01046695|Secondary|Satisfaction With Pain Control at 48 Hours|Pain control was measured by using a Visual Analog Scale (VAS) with a range from 0-10; with 0 being very satisfied and 10 being very dissatisfied.|48 hours after awakening from video-assisted thoracic surgery|11 participants on each arm did not complete the VAS.||participants|||Number
75937|NCT01046695|Secondary|Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours|As subjects could have been prescribed many different analgesics, the amount of pain medication was converted to the standard oral morphine equivalents (OME), so that the mean dose needed could be compared.|24 hours and 48 hours after awakening from video-assisted thoracic surgery|||mg of oral morphine||Standard Deviation|Mean
75938|NCT01046682|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks|Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.|Entry and week 13 visits|Number of participants for analysis was determined by the number of participants that had 2 FMD tests performed||% change from baseline||Inter-Quartile Range|Median
75939|NCT01046643|Secondary|Neuropsychological Testing Scores - Visual Learning Retention|"Changes in neuropsychological testing measures (visual learning retention) with hormone use (either estradiol or progesterone) versus placebo.~Subjects are given tests that present them with a series of pictures. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the California Verbal Learning Test - 2nd edition.~The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.||percent retention||Standard Deviation|Mean
75940|NCT01046643|Primary|Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in visual tasks with hormone use (either estradiol or progesterone) versus placebo.~The test is a visual working memory task, where the women are presented with 3 geometric grids on the screen. The target grid is on top, and 2 test grids are on the bottom. The women must decide if the right or left test grid matches the grid on top. There are 3 conditions: a match condition where all 3 grids are shown simultaneously, and 2 delay conditions, where the target grid is shown first, disappears, and the test grids appear after a 1 or a 4 second delay.~The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.||percent BOLD signal changes||Standard Deviation|Mean
75941|NCT01046643|Secondary|Neuropsychological Testing Scores - Verbal Learning Retention|"Changes in neuropsychological testing measures (verbal learning retention) with hormone use (either estradiol or progesterone) versus placebo.~Subjects are given tests that present them with a series of words. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the Benton Visual Memory Test, Revised.~The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.||percent retention||Standard Deviation|Mean
75942|NCT01046643|Primary|Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in verbal tasks with hormone use (either estradiol or progesterone) versus placebo.~The test is a deep and shallow verbal processing task, where the subjects are presented lists of words, one word at a time, and are asked to make one of 2 decisions about each list. One decision is whether each word is written in upper or lower case letters (shallow processing), and the other decision is whether each word denotes an abstract or concrete concept (deep processing).~The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged and unable to be used in the analysis.||percent BOLD signal changes||Standard Deviation|Mean
75943|NCT01046565|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)||participants|||Number
75944|NCT01046565|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 – 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol||participants|||Number
97597|NCT00835185|Secondary|Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, AUC results were not collected.|||||
75946|NCT01046396|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 – 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol||participants|||Number
75947|NCT01046253|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
75948|NCT01046253|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
75949|NCT01046253|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng/mL||Standard Deviation|Mean
75950|NCT01046136|Primary|Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.|Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.|Baseline and Day 4|||units on a scale||Standard Deviation|Mean
75951|NCT01046136|Secondary|Number of Patients With Adverse Events|Total number of patients with adverse events that were possibly or probably related.|7 days|All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused.||participants|||Number
75952|NCT01046136|Primary|Investigator's End of Study Assessment of Treatment|Yes the investigator would use this treatment for cold symptoms in the future.|7 days|MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population.||participants|||Number
75953|NCT01046110|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One site was closed, hence 11 randomised subjects (4 in IDeg and 7 in DPP-IV group/arm) were excluded from the FAS. Fasting plasma glucose values were missing for another 8 subjects, hence did not contribute to the analysis.||mmol/L||Standard Deviation|Mean
75954|NCT01046110|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). A site was closed, hence 11 randomised subjects (4 subjects with IDeg; 7 subjects with DPP-IV group/arm) were excluded from the FAS.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
75955|NCT01046084|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
75956|NCT01046084|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng*h/mL||Standard Deviation|Mean
75957|NCT01046084|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).||ng/mL||Standard Deviation|Mean
75958|NCT01045993|Secondary|Number of Participants Per Categorical Score for Global Assessment of Study Treatment|At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.||participants|||Number
75959|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75960|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75961|NCT01045993|Secondary|Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension|Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75962|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||degrees||Standard Deviation|Mean
75963|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||degrees||Standard Deviation|Mean
75964|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||degrees||Standard Deviation|Mean
75965|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75966|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75967|NCT01045993|Secondary|Change From Baseline (Bsl) in Combined Flexibility Score: Extension|Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75968|NCT01045993|Secondary|Change From Baseline in Individual Time-point Back Stiffness Scores|Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness).|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.||scores on a scale||Standard Deviation|Mean
75969|NCT01045993|Secondary|Individual Time-Point Pain Relief Scores|Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief.|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.||scores on a scale||Standard Deviation|Mean
75970|NCT01045993|Secondary|Time to Treatment Failure|Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study).|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population. Time to treatment failure not calculable as there were no treatment failures in this study. No participants required use of rescue medication or discontinued study prior to 8 hour evaluation.|||||
75971|NCT01045993|Secondary|Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours|Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75972|NCT01045993|Secondary|Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)|TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.||scores on a scale||Standard Deviation|Mean
75973|NCT01045993|Primary|Time to First Perceptible Relief (Confirmed by Meaningful Relief)|"“First perceptible relief” defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled “first perceptible relief” (any pain relieving effect), provided the participant also depressed the second stopwatch labeled meaningful relief” (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee."|Baseline (time of wrap application or oral treatment administration) up to 4 hours|Intent-to-treat population (ITT): all randomized participants who applied/dosed with study product and had a baseline assessment. Median and/or upper limit of CI reported as 240 minutes if >240 minutes. No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.||minutes||95% Confidence Interval|Median
75974|NCT01045993|Secondary|Time to Meaningful Relief|Time to “meaningful relief” defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating “meaningful relief” (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee.|Baseline (time of wrap application or oral treatment administration) up to 4 hours|ITT population. Median and/or upper limit of CI reported as 240 minutes if median or upper limit >240 minutes.||minutes||95% Confidence Interval|Median
75975|NCT01045967|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
75976|NCT01045967|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
75977|NCT01045967|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
75978|NCT01045798|Primary|The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study.|"The feasibility of conducting a major randomized study of caspofungin for empirical therapy for invasive candidiasis in high-risk non-neutropenic intensive care unit (ICU) participants was to be assessed by the incidence of study therapy discontinuations due to investigators choosing to treat participants with empirical antifungal therapy outside of the context of this protocol.~Study drug was administered for a minimum of 7 days to a maximum of 14 days provided participants had no evidence of confirmed breakthrough invasive Candida infection while receiving study drug."|1 to 14 days|Of the 114 participants anticipated to enroll in this study, 15 actually enrolled and only 14 received study drug. The participant who did not receive study drug was discontinued; the remaining 14 received at least one dose of study drug, met inclusion/exclusion criteria, and therefore qualified for the full analysis set used for summary analyses.||Participants|||Number
75979|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
75980|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
75981|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
76020|NCT01045096|Primary|The Peak Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng/mL||Standard Deviation|Mean
75982|NCT01045707|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed. For 24 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
75983|NCT01045707|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
75984|NCT01045707|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
75985|NCT01045551|Secondary|Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)||Week 12, Week 16|||telangiectasia count||Standard Error|Mean
75986|NCT01045551|Secondary|Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)|physician count of telangiectasias on the face at visit 1 (baseline) compared to at visit 8 (week 12)|Baseline, Week 12|||telangiectasia count||Standard Error|Mean
75987|NCT01045551|Secondary|Change From Baseline in Erythema Rating Visit 8 (Week 12)|The change in the Physician Overall Erythema Severity. Scale range 0 - 3. 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe. 0 is considered a better outcome, 3 is considered a worse outcome.|Baseline, Week 12|||units on a scale||Standard Deviation|Mean
75988|NCT01045551|Secondary|Change in Physician 7 Point Global Assessment From Baseline to Week 12|The Physician Global 7-point Assessment. Scale range: 0-7. 0 = clear, 1 = minimal, 2 = mild, 3 = mild to moderate, 4= moderate, 5= moderate to severe, 6 = severe. 0 is a better outcome, 6 is a worse outcome. No subscales were used.|Baseline, week 12|||units on a scale||Standard Deviation|Mean
75989|NCT01045551|Primary|Change From Baseline in the Total Number of Papulopustular Lesions at Week 12|Papule and pustule count consisted of direct measurement of the number of papules/pustules on the face. Papule and pustule count, compared between baseline and end of treatment Week 12 was calculated|Baseline to Week 12|||papule count||Standard Deviation|Mean
75990|NCT01045447|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS. For 23 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
75991|NCT01045447|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
75992|NCT01045421|Secondary|Phase 2: Relationship Between Clinical Response and Molecular Markers of Response|In SCLC,chemo-sensitive/resistant population were analyzed;in breast cancers,ER2 and ER2 status were analyzed.HR+ =estrogen receptor-positive or progesterone receptor-positive. HER+ =human epidermal growth factor receptor 2 (HER2). Triple negative =negative for estrogen receptors, progesterone receptors, and HER2.Clinical response according to RECIST version 1.1. CR:complete disappearance of all target lesions,non-target disease,except nodal disease;all nodes decrease to normal (short axis <10 mm);no new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions (SLD);short axis was used in the sum for target nodes,longest diameter used in the sum for all other target lesions;no unequivocal progression of non-target disease;no new lesions. Progressive Disease (PD): >=20% rise in SLD from the smallest value on study;unequivocal progression of existing non-target lesions. Stable Disease (SD):Neither sufficient shrinkage for PR nor sufficient increase for PD.|12 months|Response-Evaluable population. Data is reported only for SCLC and breast cancer cohorts becuase these cohorts showed clinical meaningful single agent activity, thus subgroup analysis were done to assess whether a particular subgroup of participants was more or less responsive to alisertib. Rest of the cohorts did not show meaningful activity.||percentage of participants||95% Confidence Interval|Number
75993|NCT01045421|Secondary|Phase 1: Steady State Oral Clearance (CLss/F) for Alisertib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-tau), expressed in liter per hour (L/hr).|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.||L/hr||Geometric Coefficient of Variation|Geometric Mean
75994|NCT01045421|Secondary|Phase 1: Peak to Trough Ratio for Alisertib|Peak to trough ratio was estimated as a ratio of Cmax at Day 7 and the minimum observed plasma concentration (Ctrough) of alisertib at Day 7. Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Ctrough is the minimum plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||ratio||Standard Deviation|Mean
76040|NCT01044732|Primary|Detection Rates for Adenomas and for Total Polyps|Numbers of polyps and adenomas detected in first and second procedures for each group|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|Per-protocol population||Polyps or adenomas detected|||Number
75995|NCT01045421|Secondary|Phase 1: Rac- Accumulation Ratio for Alisertib|Rac was estimated as a ratio of AUC (0-tau) at Day 7 and AUC (0-tau) at Day 1. Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||ratio||Standard Deviation|Mean
75996|NCT01045421|Secondary|Phase 1: Terminal Phase Elimination Half-life (T1/2) for Alisertib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.||hours||Standard Deviation|Mean
75997|NCT01045421|Secondary|Phase 1: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||nanomole*hour (nM*hr)||Geometric Coefficient of Variation|Geometric Mean
75998|NCT01045421|Secondary|Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 1 and Day 7 assessment were available.||hours||Full Range|Median
75999|NCT01045421|Secondary|Phase 1: Cmax- Maximum Observed Plasma Concentration for Alisertib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours post-dose|Pharmacokinetic (PK)-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.||nanomole (nM)||Geometric Coefficient of Variation|Geometric Mean
76000|NCT01045421|Secondary|Phase 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after the last dose of study drug|Safety population included all participants who received any amount of alisertib.||participants|||Number
76001|NCT01045421|Secondary|Phase 2: Duration of Response (DOR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response=(the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). CR: complete disappearance of all target lesions and non-target disease, except nodal disease; all nodes decreased to normal; no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. Tumor progression: >=20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); absolute increase of >=5 mm; appearance of >=1 new lesions is also considered progression. DOR calculated for the subgroup of participants with objective response.|Baseline up to Week 50|Included a subset of response-evaluable population who had objective tumor response.||days||95% Confidence Interval|Median
76002|NCT01045421|Secondary|Phase 2: Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until disease progression, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.||days||95% Confidence Interval|Median
76003|NCT01045421|Secondary|Phase 2: Progression-free Survival (PFS)|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until progressive disease, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.||days||95% Confidence Interval|Median
76019|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL||Standard Deviation|Mean
76004|NCT01045421|Primary|Phase 2: Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until complete response or partial response, assessed every 2 cycles up to end of study (up to 50 cycles)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
76005|NCT01045421|Primary|Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)|Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/cubic meter [cells/mm^3]) for >7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets <25,000 cells/mm3) for >7 days; Platelet count <10,000 cells/mm3; Grade 3 thrombocytopenia with clinically significant bleeding; Delay in initiation of the subsequent therapy cycle by >7 days due to treatment-related toxicity; >=Grade 3 nonhematological toxicity except >=Grade 3 nausea/emesis occurred in the absence of optimal antiemetic therapy; >=Grade 3 diarrhea occurred in the absence of optimal supportive therapy with loperamide/comparable antidiarrheal; Grade 3 fatigue for <1 week; Other Grade 3 nonhematological toxicity that could be safely, reliably controlled to <=Grade 2 with appropriate treatment.|Phase 1: Cycle 1 Day 1 to Cycle 2 Day 21|DLT-Evaluable population: all participants in the Phase 1 portion of the study who either experienced DLT during Cycle 1 or completed at least 85% of the planned doses of alisertib and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.||participants|||Number
76006|NCT01045265|Secondary|Semen to Plasma Distribution of Raltegravir|Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.|6 months|||ratio||Inter-Quartile Range|Median
76007|NCT01045265|Secondary|Seminal Distribution of Raltegravir|Determine the area under the concentration time curve of raltegravir in semen.|6 months|||h mg/l||Inter-Quartile Range|Median
76008|NCT01045265|Secondary|Semen to Plasma Raltegravir Concentrations|Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.|6 months|||ratio||Inter-Quartile Range|Median
76009|NCT01045265|Primary|Seminal Concentrations of Raltegravir.|Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.|6 months|||mg/l||Inter-Quartile Range|Median
76010|NCT01045187|Secondary|Assess Occurence Rate of Toxicities||through 3 month follow up post treatment||||||
76011|NCT01045187|Secondary|Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice||through 3 month post treatment||||||
76012|NCT01045187|Primary|Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System||through completion of radiation therapy|||Participants|||Number
76013|NCT01045161|Secondary|Part B: Peak FEV1|Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.||L||Standard Error|Least Squares Mean
76014|NCT01045161|Primary|Part B: Morning Predose (Trough) FEV1|Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.||L||Standard Deviation|Mean
76015|NCT01045161|Secondary|Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.||L||Standard Error|Least Squares Mean
76016|NCT01045161|Primary|Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.||L||Standard Error|Least Squares Mean
76017|NCT01045122|Primary|Respiratory Disturbance Index|respiratory events (apneas, hypopneas) per hour|during infusion of study drugs|Per protocol||events per hour||Standard Deviation|Mean
76018|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL||Standard Deviation|Mean
76041|NCT01044706|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|maximum observed concentration of drug substance in plasma|144 hour|||ng/mL||Standard Deviation|Geometric Mean
76021|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL/mg||Standard Deviation|Mean
76022|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng*hr/mL/mg||Standard Deviation|Mean
76023|NCT01045096|Other Pre-specified|Dose-normalized Peak Plasma Concentration (Cmax/Dose)|Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||ng/mL/mg||Standard Deviation|Mean
76024|NCT01045096|Primary|Time to Reach the Peak Plasma Concentration (Tmax)|Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic (PK) set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.||hours||Standard Deviation|Mean
76025|NCT01045057|Secondary|Postoperative Results|Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.|1 month|Only patients with secondary puncture filled out questionnaire. Seven patients had secondary puncture. One patient refused to fill out questionnaire. Six patients remained. Analysis per protocol.||Number of patients|||Number
76026|NCT01045057|Secondary|Cost Effectiveness Calculation|"cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set.~Measurements are: time needed to perform procedure"|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.||seconds||Standard Deviation|Mean
76027|NCT01045057|Secondary|Satisfaction of Physician|Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.||Number of times new set was preferred|||Number
76028|NCT01045057|Primary|Success Rate of Procedure|As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.|immediate observation during surgery|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.||Nr part. with succesful insertions|||Number
76029|NCT01045031|Secondary|Insulin-like Growth Factor (IGF-1)||Baseline and 5 years|||ng/mL||Standard Deviation|Mean
76030|NCT01045031|Secondary|Self Rating by Questionnaires|The following self rating scales were used: WHO-5 Quality of Life Assessment (Braeher, E., Muehlan, H., Albani, C., & Schmidt, S. (2007). Testing and standardization of the German version of the EUROHIS-QOL and WHO-5 quality-of life-indices. Diagnostica, 53(2), 83-96.). Range: 0 - 25, higher scores indicate better quality of life.|Baseline and 5 years|Study population (Baseline and follow-up)||point scale||Standard Deviation|Mean
76031|NCT01045031|Primary|Brain-derived Neurotrophic Factor (BDNF)||Baseline and 5 years|Baseline values differ from published data, since BDNF-levels had to be re-assessed from banked material due to a manufacturer-based change of the analysis kit.||ng/mL||Standard Deviation|Mean
76032|NCT01045031|Primary|the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment|Hypothesis will be tested at the second follow-up examinations.|10 years||12/2019||||
76033|NCT01044862|Secondary|Live Birth Rate||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||participants|||Number
76034|NCT01044862|Secondary|Time to Pregnancy||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||days||Standard Deviation|Mean
76035|NCT01044862|Secondary|Rate of Pregnancy Obtained||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||participants|||Number
76036|NCT01044862|Primary|Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks|||number of multiples|||Number
76037|NCT01044771|Secondary|Patients Without HIV Re-bound|HIV Viral load blood test at week 24|24 weeks|Subjects entered with undetectable Viral Load and Proteinuria||participants|||Number
76038|NCT01044771|Primary|Patients With Reduced or Resolved Proteinuria|Measurement of Protein in Urine samples at end of study visit|24 weeks|||participants|||Number
76039|NCT01044732|Secondary|Times for Withdrawal Phase and for Complete Procedure|For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|All subjects in study (i.e., Group A and Group B combined)||Minutes||Standard Deviation|Mean
76044|NCT01044693|Secondary|Orthostatic Tolerance the Following Morning|Orthostatic tolerance was defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test|10 min standing|Comparisons were made only for patients who could stand after all treatment groups||mm Hg*min||Standard Error|Mean
76045|NCT01044693|Secondary|Nocturnal Urinary Sodium Excretion|Nocturnal sodium excretion was defined as the ratio of urinary sodium to urinary creatinine.|8 pm - 8 am|Participants with complete urine collections during the 4 study nights||mEq/mg||Standard Error|Mean
76046|NCT01044693|Primary|Change in Systolic Blood Pressure During the Night|Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention|8 pm - 8 am|Participants who completed the 4 treatment arms||mm Hg||Standard Error|Mean
76047|NCT01044498|Secondary|Serum C-reactive Protein (CRP) Level|Blood samples were collected pre-dose of tocilizumab infusion on Day 1 of Cycle 2 and on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and on Days 1, 7, and 21 of Cycle 3. Serum levels of C-reactive protein were measured by the Tina-quant CRP (latex) high-sensitivity Roche Immunoturbidimetric method.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||mg/L||Standard Deviation|Mean
76048|NCT01044498|Secondary|Serum Soluble Interleukin-6 Receptor (sIL-6R) Level|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. Serum levels of soluble interleukin-6 receptor were analyzed using a validated ELISA.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||ng/mL||Standard Deviation|Mean
76049|NCT01044498|Secondary|Apparent Volume of Distribution (Vz) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The apparent volume of distribution (Vz), computed as CL/Kel where CL is clearance and Kel is the apparent elimination rate, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||L||Standard Deviation|Mean
76050|NCT01044498|Secondary|Clearance (CL) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. Clearance (CL), computed as dose/AUCinf, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||mL/hr||Standard Deviation|Mean
76051|NCT01044498|Secondary|Terminal Half-life (t½) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The terminal half-life (t½) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
76052|NCT01044498|Secondary|Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The area under the serum concentration-time curve from 0 to infinity (AUCinf) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above). AUCinf was computed using the linear trapezoidal rule to tlast plus Clast/Kel, where tlast is the time of the last measurable concentration, Clast is the last measurable concentration, and Kel is the apparent elimination rate, computed as the magnitude of the slope from the log-linear regression of the apparent terminal elimination phase of the serum concentration-versus-time curve.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||µg•hr/mL||Standard Deviation|Mean
76053|NCT01044498|Secondary|Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The time to reach maximum serum concentration was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
76054|NCT01044498|Secondary|Maximum Observed Serum Concentration (Cmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated enzyme-linked immunosorbent assay (ELISA). The maximum observed plasma concentration (Cmax) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||µg/mL||Standard Deviation|Mean
76055|NCT01044498|Secondary|Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The apparent oral clearance (CL/F) was derived from the plasma concentrations using a non-compartmental method and computed as dose/AUC0-24 with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||mL/hr||Standard Deviation|Mean
76056|NCT01044498|Secondary|Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The terminal half-life (t½) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
76057|NCT01044498|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||pg•hr/mL||Standard Deviation|Mean
76058|NCT01044498|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The time to reach the maximum plasma concentration (Tmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.||hr||Standard Deviation|Mean
76059|NCT01044498|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The maximum observed plasma concentration (Cmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.||pg/mL||Standard Deviation|Mean
76060|NCT01044498|Primary|Serum Progesterone Level|Blood samples were collected prior to the administration of Ortho-Novum® 1/35 on Day 21 of each cycle. Serum levels of progesterone were quantitatively determined using the ADVIA Centaur and ADVIA Centaur XP systems (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). The assay was a competitive immunoassay using direct chemiluminescent technology.|Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.||ng/mL||Standard Deviation|Mean
76061|NCT01044459|Secondary|Change From Baseline in Peak FEV1|Change From Baseline in Peak FEV1 in liters at Week 52.|52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.||L||Standard Error|Least Squares Mean
76062|NCT01044459|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.|From baseline to 52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.||L||Standard Error|Least Squares Mean
76063|NCT01044303|Secondary|To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.||24 months|||participants|||Number
76064|NCT01044303|Primary|Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)||24 months|This was a pilot study to examine the effect of MPA escalation on DSA reduction.||percent of MFI change||Standard Deviation|Mean
76065|NCT01044290|Secondary|FACT-G - Social Sub-scale|"Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating not at all and 4 indicating, very much in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being."|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)|||units on a scale||Standard Deviation|Mean
76066|NCT01044290|Primary|QUAL-E Life Completion Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)|||units on a scale||Standard Deviation|Mean
76067|NCT01044290|Secondary|FACIT-SP|The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.|Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)|||units on a scale||Standard Deviation|Mean
76068|NCT01044290|Secondary|CES-D|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)|||units on a scale||Standard Deviation|Mean
76069|NCT01044290|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 0-20. Higher scores indicate greater anxiety.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)|||units on a scale||Standard Deviation|Mean
76070|NCT01044290|Primary|QUAL-E - Preparation Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)|||units on a scale||Standard Deviation|Mean
76071|NCT01044264|Primary|Reduction of Inflammatory Lesions|The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).|Baseline and week 11|per-protocol population||percentage reduction of lesions|||Number
76072|NCT01044212|Secondary|Consistency of First Postoperative Bowel Movement|"The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.~The seven types of stool are:~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid"|Within 1 week of surgery|||Bristol Stool Scale||Standard Deviation|Mean
76073|NCT01044212|Secondary|Pain Level Associated With First Postoperative Bowel Movement|The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.|Within 1 week of surgery|||VAS pain score||Standard Deviation|Mean
76074|NCT01044212|Primary|Time to First Post-op Bowel Movement|The time to first post-operative bowel movement was measured in hours after surgery.|Within 1 week of surgery|Power analysis||hours||Standard Deviation|Mean
76075|NCT01044056|Primary|AUC 0-infinity (PK Parameter) for the ASPE Group.|AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.|21 days of active treatment and the washout period thereafter|||ng.h/mL||Standard Deviation|Mean
76076|NCT01044056|Primary|AUC 0-tlast (PK Parameter) for the ASPE Group.|AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication.||ng.h/mL||Standard Deviation|Mean
76077|NCT01044056|Primary|Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group|AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment|21 days|Subjects who received at least one dose of medication.||nh.h/mL||Standard Deviation|Mean
76078|NCT01044056|Primary|Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group|Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication||pg/ml||Standard Deviation|Mean
76079|NCT01044030|Secondary|Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo.||12 weeks||||||
76080|NCT01044030|Secondary|Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae|Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites|12 weeks|This outcome measure is limited to those subjects enrolled in the local enrolling sites only.||percentage of participants|||Number
76081|NCT01044030|Secondary|Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media|Proportion of subjects with no antibiotic use during the study period|12 weeks|||percentage of participants|||Number
76082|NCT01044030|Primary|Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media|Proportion of subjects who remained free of acute otitis media throughout the study period|12 weeks|||percentage of particpants|||Number
76083|NCT01043939|Secondary|Change in High Sensitivity C-Reactive Protein (Hs-CRP)|Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation|4 weeks|||mg/L||95% Confidence Interval|Geometric Mean
76086|NCT01043939|Primary|Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)|"Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function.~Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during & after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function."|4 weeks (change since baseline)|Intent-to-Treat analysis||units on a scale||Standard Error|Least Squares Mean
76087|NCT01043926|Secondary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
76088|NCT01043926|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants||participants|||Number
76089|NCT01043926|Primary|AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|Per protocol, the decision to perform AUC(0-∞) analysis in mild hepatic insufficiency participants was conditional on results of AUC(0-∞) analysis in moderate hepatic insufficiency participants. Since the primary hypothesis in moderate hepatic insufficiency participants was met, AUC(0-∞) analysis in mild hepatic insufficiency was not done.|||||
76090|NCT01043926|Secondary|Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants|Cmax was defined as the maximum observed concentration of a drug after administration.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants||μM||95% Confidence Interval|Geometric Mean
76091|NCT01043926|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants||μM•hr||95% Confidence Interval|Geometric Mean
76092|NCT01043874|Secondary|Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set||% participants w/ durable MMR at 24 mos||95% Confidence Interval|Number
76093|NCT01043874|Secondary|Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set||months||Standard Deviation|Mean
76094|NCT01043874|Secondary|MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|24 months after treatment|Full Analysis Set||% participants achieving MMR||95% Confidence Interval|Number
76095|NCT01043874|Primary|MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later.|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|12 months after treatment|Full Analysis Set||% participants achieving MMR||95% Confidence Interval|Number
76096|NCT01043705|Primary|CIED Mechanical Complication|All mechanical Complications related to CIED Implant|12 months|"TYRX implants vs. published comparator are prospective arm patients. Non-TYRX CIED retrospective arm vs. TYRX CIED replacements are nested, case-control cohort."||percentage of Participants||95% Confidence Interval|Number
76097|NCT01043705|Primary|Major CIED Infection|CIED Major Infections|12 months|Evaluable patients that have valid entry criteria||percentage of Participants||95% Confidence Interval|Number
76098|NCT01043653|Secondary|Maryland Assessment of Recovery in Serious Mental Illness|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~ 1-year|||units on a scale||Standard Deviation|Mean
76099|NCT01043653|Primary|Positive and Negative Symptom Scale (PANSS)|The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.|~1-year|The PANSS had additional missing data from 3 participants||units on a scale||Standard Deviation|Mean
76100|NCT01043523|Other Pre-specified|Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76101|NCT01043523|Other Pre-specified|Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76102|NCT01043523|Other Pre-specified|Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76103|NCT01043523|Other Pre-specified|Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76104|NCT01043523|Other Pre-specified|Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76105|NCT01043523|Secondary|Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.|Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease.|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Percentage points|||Number
76106|NCT01043523|Secondary|Final Diagnosis (SoT) by Clinical Investigator||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76107|NCT01043523|Secondary|The Overall Image Quality for the Postcontrast Image Only||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76108|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management / Therapy – Comparison of Precontrast Versus Combined Precontrast/Postcontrast Images (Only Subjects for Whom a Change Was Documented)||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy.||Participants|||Number
76109|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76110|NCT01043523|Secondary|Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76111|NCT01043523|Secondary|Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76112|NCT01043523|Secondary|Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76113|NCT01043523|Secondary|Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Participants|||Number
76114|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast||mmHg||Standard Deviation|Mean
76115|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast||mmHg||Standard Deviation|Mean
76116|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Heart Rate||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast||beats/min||Standard Deviation|Mean
84368|NCT00961805|Secondary|Quality of Life - Sf-36 - General Health State|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
76117|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection|The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels.|Up to 24 hours post-Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected||Participants|||Number
76118|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point|Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels.|14 days prior to Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected||Participants|||Number
76119|NCT01043523|Primary|Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.|Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)||Percentage of participants||95% Confidence Interval|Number
76120|NCT01043432|Primary|Iowa Gambling Test|Iowa Gambling Test - Total Raw Score The Iowa Gambling task requires examinees to sit in front of a computer screen displaying four decks of cards (Decks A, B, C, and D) and select a card from any of the four decks. Decks A and B are the disadvantageous decks because they produce high immediate gains however over time examinees will experience a higher loss. Decks C and D are the advantageous decks because they produce lower gains but over time examinees will experience smaller losses. Examinees will make 100 choices (trials). To measure performance, the 100 trials are divided, in order, into 5 'blocks’ of 20. A net score is calculated for each block as the number of cards selected from the advantageous decks minus the disadvantageous decks and the total raw score is the sum of the scores for blocks 1-5. The overall total score can range from -100 (worst outcome) to 100 (best outcome)and the score for each block can range from -20 to 20|One time - for the vast majority of participants the research protocol was initiated directly after informed consent procedures were completed (within hours). Negative values are possible with this measure, see Outcome Description.|||Total Raw on a scale from -100 to 100||Standard Deviation|Mean
76121|NCT01043393|Secondary|Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis|The PGA scale is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|28 days|No statistical analysis provided for Percentage of Participants With a Physician’s Global Assessment (PGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)||percentage of physician’s global assessm||Standard Deviation|Mean
76122|NCT01043393|Secondary|Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis|"Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600)~BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~%Body Surface Area Affected the Rule of Nine was be used"|28 days|"No statistical analysis provided for Percentage of Body Surface Area Affected by Psoriasis.~As the study is not powered sufficiently to perform efficacy statistical analysis, descriptive statistical analysis are presented on the mean change from baseline in % BSA affected"||percentage of Body Surface Area Affected||Standard Deviation|Mean
76123|NCT01043393|Primary|Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression|Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.|28 days|||participants|||Number
76124|NCT01043185|Secondary|Number of Weakly Alkaline Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||Full Range|Median
76125|NCT01043185|Secondary|Number of Weakly Acidic Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0–6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||95% Confidence Interval|Geometric Mean
76163|NCT01042535|Secondary|Phase 2 – Median Progression Free Survival (PFS) in Weeks|Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS: Time from study entry to documentation of radiologic progressive disease or death, assessed up to 3 years.|Up to 3 years|All evaluable participants at time of analysis||weeks||Full Range|Median
76126|NCT01043185|Secondary|Number of Acid Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||95% Confidence Interval|Geometric Mean
76127|NCT01043185|Primary|Total Number of Reflux Episodes During 24 Hours|Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.||Episodes||95% Confidence Interval|Geometric Mean
76128|NCT01043146|Primary|The Number of Participants Reporting Adverse Events (AEs)|To assess the safety and tolerability of COR-1.|45 days|||Participants|||Number
76129|NCT01043133|Secondary|Clinical Note Completeness Score|The Note Completeness Score is a total score (range 1-31)earned when a clinical encounter note is compared against a note completeness score assessment tool designed by our research team. The tool measures 11 documentation components of the outpatient note. Each of the 11 components are scaled either 0-1 or 0-4 based on perceived importance by our physician designers.|immediately after intervention and 30+ days in follow-up|||score||Standard Deviation|Mean
76130|NCT01043133|Primary|Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record|The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).|immediately after invervention and 30+ days in follow-up|||participants|||Number
76131|NCT01043094|Secondary|Number of Participants With Treatment Emergent Adverse Events||3 Days|||Participants|||Number
76132|NCT01043094|Primary|Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))|Area under the curve from start to elimination for Pitavastatin.|48 hours|||nanogram hour per milliliter (ng•h/mL)||Standard Deviation|Mean
76133|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg|To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full Analysis set, participants with baseline seated SBP ≥130 mmHg and Week 8 (LOCF) value||mmHg||95% Confidence Interval|Least Squares Mean
76134|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis set, subjects with non-missing baseline and Week 24 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
76135|NCT01042977|Secondary|Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, subjects with non-missing baseline and Week 8 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
76136|NCT01042977|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full Analysis Set, subjects with baseline BMI ≥27 kg/m2 and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
76137|NCT01042977|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
76138|NCT01042977|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Number
76139|NCT01042977|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
76140|NCT01042938|Secondary|Pain at Radiation Treatment Site|The McGill Pain Questionnaire-Short Form (MPQ-SF) was used to determine the participants pain at treatment site. The MPQ-SF contains three subscales: affective pain, sensory pain, and perceived pain. This outcome measure compared the total pain score (range 0 to 50)and subscale scores (sensory subscale range 0 to 33; affective subscale range 0 to 12; perceived pain subscale 0 to 5) at the end of radiation therapy between the two treatment arms.|4-7 weeks (prescribed course of radiation)|All 30 participants that fully completed the trial were used in these analyses.||units on a scale||Standard Deviation|Mean
76245|NCT01041404|Secondary|Body Weight (Kilograms [kg]) at BL||BL|FAS||kg||Full Range|Median
76403|NCT01040130|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
76141|NCT01042938|Secondary|Redness at Radiation Treatment Site|Redness at radiation treatment site was measured using a CR-400 Colorimeter (Konica Minolta). The colorimeter uses the L*a*b* color scale. We used a* values (redness) which range from 0.0 to 20.0. The lower the number value, the lower amount of redness. Therefore, high number values represent large amounts of redness.|4-7 weeks (prescribed course of radiation)|The 30 participants that fullt completed the trial were used in these analyses.||units on a scale (0.0 to 20.0)||Standard Deviation|Mean
76142|NCT01042938|Secondary|Moist Desquamation at Radiation Treatment Site|The presence of moist desquamation at the end of radiation treatment was examined between curcumin and placebo treatment groups. We compared the number of participants (or percentage) with moist desquamation between each treatment group.|4-7 weeks (prescribed course of radiation)|All 30 participants who completed the trial were used in all analyses.||participants|||Number
76143|NCT01042938|Primary|Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients|The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.|4-7 weeks (prescribed course of radiation)|We used all 30 participants that fully completed the trial in all of our analyses.||units on a scale||Standard Deviation|Mean
76144|NCT01042678|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|All treated participants.||Participants|||Number
76145|NCT01042678|Secondary|Aqueous Humor Levels of MP0112|Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|1 Week|All treated participants who consented to participate.||nM||Full Range|Median
76146|NCT01042678|Secondary|Serum Levels of MP0112|Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|16 Weeks|All treated participants.||Nanomolar (nM)||Full Range|Median
76147|NCT01042678|Secondary|Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness).|Baseline, Week 16|All treated participants.||microns||Standard Deviation|Mean
76148|NCT01042678|Secondary|Best-Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision.|Baseline, Week 16|All treated participants with data for a given time point were included for analysis.||Letters||Standard Deviation|Mean
76149|NCT01042678|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|16 weeks|All treated participants.||Participants|||Number
76150|NCT01042613|Secondary|Number of Skin Punctures|To assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique|At cannulation|||Skin punctures||Standard Deviation|Mean
76151|NCT01042613|Secondary|Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).|To assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV 300 device as compared to the standard technique|At cannulation|Of the 146 patients, two patients were excluded due to missing time records.||Minutes||Standard Deviation|Mean
76152|NCT01042613|Primary|First Attempt Success Rate of Cannulation|This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.|At cannulation|Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.||Participants|||Number
76153|NCT01042600|Secondary|Mortality Rate||2 months|||participants|||Number
76154|NCT01042600|Secondary|Number of Intubation Episodes Per Patient||7 days||||||
76155|NCT01042600|Secondary|Complications During Insertion of LMA||96 hrs||||||
76156|NCT01042600|Secondary|Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)||2 months||||||
76157|NCT01042600|Secondary|Rate of Pneumothorax||96 hrs||||||
76158|NCT01042600|Secondary|Days on Supplemental Oxygen||2 months||||||
76159|NCT01042600|Secondary|Days on Assisted Ventilation||2 months||||||
76160|NCT01042600|Secondary|Number of Surfactant Doses||96 hr||||||
76161|NCT01042600|Primary|Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).||96 hours|||participants|||Number
76162|NCT01042535|Other Pre-specified|Phase 2 - Change in Biomarker Level|Biomarkers include serum kynurenine, serum tryptophan, C reactive protein, and circulating T-regulatory cell levels (CD4+ 25+ CD127low forkhead box protein 3+ (FoxP3+). Appropriate t-tests and/or Wilcoxon test will be employed to study changes over time.|Baseline to week 16||||||
76164|NCT01042535|Secondary|Phase 2 – Number of Participants With Clinical Benefit From Chemotherapy After Vaccination|Clinical response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years|All evaluable participants at time of analysis||participants|||Number
76165|NCT01042535|Secondary|Phase 1 - Number of Participants With Objective Response at 6 Weeks|Immunologic Response defined as Interferon-γ (IFN-γ) p53 T cell specific enzyme-linked immunospot (ELISPOT) assay count Summarized using both point estimates and the 95% exact confidence intervals based on the binomial distribution. Briefly, 2x10^5 mononuclear cells obtained from the peripheral blood of patients will be plated in quadruplicates in 96-well multiscreen mixed cellulose ester (HA) filtration plates, processed and incubated, spots will be visualized. The number of spots will be calculated per 10^6 cells. Untreated peripheral blood mononuclear cells (PBMNC) will represent a negative control and PBMNC stimulated with 10 µg/ml Concanavalin A (ConA) – positive control.|At 6 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod||participants|||Number
76166|NCT01042535|Primary|Phase 2 – Number of Participants With Stable Disease In Response to Study Therapy|Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 16 weeks|All evaluable participants at time of analysis||participants|||Number
76167|NCT01042535|Primary|Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)|MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).|Up to 4 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod||indoximod dose in mg|||Number
76168|NCT01042509|Secondary|Side Effects|Percentage of participants who experienced side effects|365 days|15 consecutive patients were included for the analysis with periodical clinical evaluations to assess adverse effects.||Participants|||Count of Participants
76169|NCT01042509|Primary|Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.|Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up|30, 90 and 365 days|All consecutive patients were included in an intention to treat analysis to evaluate clinical response to alemtuzumab and rituximab combination.||percentage of participants|||Number
76170|NCT01042496|Secondary|Glutamine/Glutamate Ratio Measured in the LDLPC at Baseline Using the ProFit Magnetic Resonance Spectroscopy (MRS) Technique|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline|Sample sizes varied between both scanning locations LDLPC and MACC and between metabolites due to imaging results/scan viability. Some subject scans yielded more viable information/ less noise during the scan process. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis.||ratio||Standard Deviation|Mean
76171|NCT01042496|Secondary|Mean Glutamate (GLU) Measured in the MACC and LDLPC Using the ProFit MRS Technique at Baseline for Both Groups, After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline, 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=8, LDLPC n=8, Bipolar group MACC n=13, LDLPC n=13. Bipolar group 12 weeks MACC n=8, LDLPC n=17. The control group did not do the procedure at 12 weeks.||Institutional Units (IU)||Standard Deviation|Mean
76172|NCT01042496|Secondary|N-acetylaspartic Acid (NAA) Measured in the MACC and LDLPC Using the Long TE (TE80) PRESS MRS Technique at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar (BP) Group and BP Responders and Non-responders|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was used for statistical analysis.|baseline, 12 weeks|Samples varied due to imaging results/scan viability. Baseline: control group MACC (M) and LDLPC (L) n=8, BP whole M n=28 (3 didn't complete), L n=27, BP Responders M n=13, L n=11, BP nonresponders M and L n=12; BP whole 12 weeks M and L n=16. BP Responders M and L n=10, BP nonresponders M and L n=6. Controls didn't do the procedure at 12 weeks.||Institutional Units (IU)||Standard Deviation|Mean
76173|NCT01042496|Secondary|Glutamate+Glutamine (GLX) Measured in Mid Anterior Cingulate Cortex (MACC) & Left Dorsal Lateral Prefrontal Cortex (LDLPC) Using Long TE PRESS MRS Technique at Baseline for Both Groups; After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in in anterior cingulate and left dorsal lateral prefrontal cortex : an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of cerebrospinal fluid (CSF); the MRS voxel was overlaid onto the CSF map and the fraction of CSF was measured. This CSF corrected measurement was used for statistical analysis.|baseline, after 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=7, LDLPC n=8, Bipolar group MACC n=18, LDLPC n=27. Bipolar group 12 weeks MACC n=12, LDLPC n=16. The control group did not do the procedure at 12 weeks.||Institutional Units (IU)||Standard Deviation|Mean
76174|NCT01042496|Primary|Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|The MADRS is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). A score of less than 12 is considered clinical remission of depression.|baseline, 12 weeks|The control group only did the MADRS depression rating scale at baseline. 25 participants in the Bipolar group took the MADRS depression rating scale at 12 weeks.||units on a scale||Standard Deviation|Mean
76175|NCT01042392|Secondary|Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|8 weeks + 1 day|All randomized patients except one patient from Aliskiren arm who was lost to follow up after visit 2.||Participants|||Number
76176|NCT01042392|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose|The change in blood pressure was measured between visit 4 (end of the period of double-blind active treatment which was at week 8) and visit 5 (48 hours after the last active dose taken) in the group of patients who received aliskiren or placebo and those who received ramipril or placebo. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|From 8 weeks to 48 hours after week 8|Per-protocol missed dose population included all per protocol population patients who had received the study treatment for period 3 according to the protocol (duration of period 3 and treatment intake). Patients with observation at both time points were included in this analysis.||mmHg||Standard Error|Least Squares Mean
76177|NCT01042392|Secondary|Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)|"The sub-groups were: Riser = patients with >= 55 mmHg difference between the mean SPB measured at the morning surge and the mean minimal SBP measured during the night. The Non-risers in whom the difference is <55 mmHg. Patients called dippers in whom there was a decrease in average nocturnal SBP ≥ 10% compared with average daytime SBP, in contrast to patients non-dippers  in whom this difference was <10%."|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at different categories were included in this analysis.||mmHg||Standard Deviation|Mean
76178|NCT01042392|Secondary|Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the eve of visit 4 (week 8), the device attached to the ambulatory blood pressure non-dominant arm of the patient. The difference between mean-hour maximum SBP mean-hour minimum SBP between 1 am and 8 am was measured.|At week 8|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM measurements over 24 hours were included in this analysis.||mmHg||Standard Deviation|Mean
76179|NCT01042392|Secondary|Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|Baseline to 4 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.||mmHg||Standard Error|Least Squares Mean
76180|NCT01042392|Secondary|Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the day before visit 4, the device attached to the ambulatory blood pressure non-dominant arm of the patient. The BP morning surge was defined as the average of the measurements taken during the first 2 hours after waking the patient. The minimal night blood pressure was defined as the average of the two lowest BP measures (the lowest hourly average) recorded during night time.|After 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM to evaluate the occurrence or absence of a morning peak were included in this analysis.||Participants|||Number
84369|NCT00961805|Secondary|Quality of Life - Sf-36 - Pain|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
76181|NCT01042392|Secondary|Percentage of Patients With Controlled Blood Pressure|"The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings.~Controlled blood pressure (BP) is defined as mean office systolic BP/ diastolic BP < 140/90 mmHg."|At 4 and 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at each time point were included in this analysis.||Percentage|||Number
76182|NCT01042392|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of variance included treatment factor and baseline value of mean sitting DBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at both time points were included in this analysis.||mmHg||Standard Error|Least Squares Mean
76183|NCT01042392|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.||mmHg||Standard Error|Least Squares Mean
76184|NCT01042288|Secondary|Frequency of Adverse Events and Severity as a Measure of Toxicity|Assessed using NCI CTCAE v4.0|Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter|||participants|||Number
76185|NCT01042288|Secondary|Objective Response Rate||Projected 18 months|All patients evaluated for response||percentage of evaluated participants|||Number
76186|NCT01042288|Secondary|Median Overall Survival (OS)|Defined as the time between Day 1-Cycle 1 to the date of death from any cause.|18 months|All enrolled and treated patients||months||95% Confidence Interval|Median
76187|NCT01042288|Secondary|Median Progression-free Survival (PFS)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression or death.|Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months|All enrolled and treated patients||months||95% Confidence Interval|Median
76188|NCT01042288|Primary|Median Time to Progression (TTP)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.|18 months|All enrolled and treated patients||months||95% Confidence Interval|Median
76189|NCT01042236|Secondary|Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration|Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Baseline, Day 7 of each period|Full Analysis Set (FAS): all randomized subjects who had taken at least one dose of study treatment; (n)=number of participants with observations (non-missing concentrations)||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
76190|NCT01042236|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only subjects with >0 participants at baseline were to be included in the analysis.||Percent||Full Range|Median
76191|NCT01042236|Secondary|Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS||Episodes per 24 hours.||Standard Deviation|Mean
76192|NCT01042236|Secondary|Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.||Percent||Full Range|Median
76193|NCT01042236|Secondary|Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS||Episodes per 24 hours.||Standard Deviation|Mean
76404|NCT01040130|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.||percentage of participants|||Number
76194|NCT01042236|Secondary|Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.||Percent||Full Range|Median
76195|NCT01042236|Secondary|Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS||Episodes per 24 hours.||Standard Deviation|Mean
76196|NCT01042236|Secondary|Change From Baseline in Closing Urethral Elastance at Day 7|Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS||cmH2O/mm^2||Standard Deviation|Mean
76197|NCT01042236|Secondary|Change From Baseline in Opening Urethral Elastance at Day 7|Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS||cmH2O/millimeter(mm)^2||Standard Deviation|Mean
76198|NCT01042236|Secondary|Change From Baseline in Closing Urethral Pressure at Day 7|Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS||cmH20||Standard Deviation|Mean
76199|NCT01042236|Primary|Change From Baseline in Opening Urethral Pressure (OUP) at Day 7|OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|Per Protocol Analysis Set (PPAS): all randomized participants who completed the study, received treatment in all 3 study periods until end of treatment visit in the third study period, and had not violated any of the inclusion / exclusion criteria or deviated from the protocol in a way that could affect the outcome of the study.||centimeter of water (cmH2O)||Standard Deviation|Mean
76200|NCT01042145|Secondary|Number of Participants With Reported Side Effects||12 days|||percentage of participants|||Number
76201|NCT01042145|Secondary|Time Missed From Work||12 days|||Hours||Standard Deviation|Mean
76202|NCT01042145|Secondary|Parental Stress|Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.|12 days|||days||Standard Deviation|Mean
76203|NCT01042145|Secondary|Nights With Disturbed Sleep||12 days|||nights||Standard Deviation|Mean
76204|NCT01042145|Secondary|Duration of Croup Symptoms||12 days|||days||Standard Deviation|Mean
76205|NCT01042145|Primary|Additional Health Care|The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.|11 days|||percentage of participants||95% Confidence Interval|Number
76206|NCT01042093|Secondary|Knee Society Pain Scores at 6 Week Follow-up Appointment|Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome.|6 weeks after surgery|||Scores on a scale 0-50||Full Range|Mean
76207|NCT01042093|Secondary|Narcotic Consumption During Hospitalization|A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3.|4 days|||mg||Standard Deviation|Mean
76208|NCT01042093|Primary|Numerical Rating Scale (NRS) Pain Scores During Hospitalization.|Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.|2 days after surgery|||scores on a scale 0-10||Standard Deviation|Mean
76209|NCT01041976|Secondary|Employment|"Yes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up.~Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up."|18 months|||participants|||Number
76210|NCT01041976|Primary|Participation in Vocational Rehabilitation Services|"Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up.~Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up."|18 months|||participants|||Number
76211|NCT01041859|Secondary|Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint|EQ-5D has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a categorical scale of 1-3 with 1=no problems, 2=some problems, 3=extreme problems. The health state index is a weighted combination of the 5 items. It has a range of 0 to 1, with 0=deceased and 1=full health.|Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.||units on a scale||Standard Deviation|Mean
76212|NCT01041859|Secondary|Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint|The BPI is a 12-item questionnaire to evaluate the intensity of pain and the degree to which pain interferes with function. It includes 4 items assessing current pain intensity and pain at its worst, least, and on average over the past day using an 11-point scale from 0 = no pain to 10 = pain as bad as you can imagine. The pain intensity subscale score is defined as the mean of the scores from these 4 items.|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.||units on a scale||Standard Deviation|Mean
76213|NCT01041859|Secondary|Distribution of Patient Global Impression of Change at Week 12 Endpoint|Patient Global Impression of Change (PGIC) is a patient-rated assessment of overall neuropathic pain since the start of treatment using a categorical scale 1-7, where 1 is ‘very much improved’ and 7 is ‘very much worse’|End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point||percentage of participants|||Number
76214|NCT01041859|Secondary|Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint|"The NRS was a twice-daily pain assessment in which patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point scale with a score of 0 indicating no pain and a score of 10 indicating pain as bad as you can imagine."|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation.||percentage of participants|||Number
76215|NCT01041859|Primary|Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12|"For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation||units on a scale||Standard Deviation|Mean
76216|NCT01041638|Secondary|Overall Survival|Estimated using Kaplan-Meier curves.|From enrollment until death, or until last contact with the patient, up to 5 years||||||
76217|NCT01041638|Secondary|Event-free Survival|Estimated using Kaplan-Meier curves.|From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 5 years||||||
76218|NCT01041638|Primary|Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).|Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.|Up to 5 years|"There was one patient that did not receive treatment, represented on the baseline form as withdrawal by patient, not included in outcome measure tabulation."||percentage of participants|||Number
76219|NCT01041573|Secondary|Rate of Subjects With Abnormal Laboratory Parameters||study duration||||||
76220|NCT01041573|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7||Day 56 and up to Month 7||||||
76221|NCT01041573|Secondary|Rate of Subjects With Solicited Local and Systemic AEs||study duration||||||
76222|NCT01041573|Secondary|Rate of Subjects With SAEs and Medically Attended AEs up to Month 7||up to Month 7||||||
76223|NCT01041573|Secondary|Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies and SCR at Days 0, 56 and at Month 7||Day 0, 56 and at Month 7||||||
76224|NCT01041573|Primary|Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination|Comparing study participants 1 year and above receiving IC51 0.25mL, IC51 0.5 mL and Havrix|until Day 56|||percentage of participants||95% Confidence Interval|Number
76225|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
76226|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
76227|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
76228|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
76246|NCT01041404|Secondary|Percentage of Participants With a Change in Analgesic Medication During the Study|Analgesic medications were recorded throughout the study until disease progression.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
76229|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
76230|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
76231|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
76232|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
76233|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
76234|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
76235|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 6 months|||units on a scale||95% Confidence Interval|Mean
76236|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 3 months|||units on a scale||95% Confidence Interval|Mean
76237|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 6 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 6 months|||seconds||95% Confidence Interval|Mean
76238|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 3 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 3 months|||seconds||95% Confidence Interval|Mean
76239|NCT01041417|Secondary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 6 months|||seconds||95% Confidence Interval|Mean
76240|NCT01041417|Primary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 3 months|||seconds||95% Confidence Interval|Mean
76241|NCT01041404|Secondary|Trastuzumab Maximum Serum Concentration (Cmax)|Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population||mg/L||90% Confidence Interval|Median
76242|NCT01041404|Secondary|Trastuzumab Minimum Serum Concentration (Cmin)|Median Cmin (measured as milligrams per liter [mg/L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population||mg/L||90% Confidence Interval|Median
76243|NCT01041404|Secondary|Steady State Trastuzumab Area Under the Concentration (AUC)|Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by [*] day per liter [L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.||mg*day/L||90% Confidence Interval|Median
76244|NCT01041404|Secondary|Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight|Change in body weight was categorized as an increase of greater than (>)5 percent (%), no change (plus or minus [±]5%), decrease of >5-10%, or a decrease of >10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.||percentage of participants|||Number
76247|NCT01041404|Secondary|Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)|The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.||mm||Standard Error|Mean
76248|NCT01041404|Secondary|EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores|The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.||scores on a scale||Standard Error|Mean
76249|NCT01041404|Secondary|European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n (number) = number of participants assessed for a specific parameter at a given visit.||scores on a scale||Standard Error|Mean
76250|NCT01041404|Primary|Overall Survival - Time to Event|The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||months||95% Confidence Interval|Median
76251|NCT01041404|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants||95% Confidence Interval|Number
76252|NCT01041404|Secondary|Duration of Response|The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.||months||95% Confidence Interval|Median
76253|NCT01041404|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.||percentage of participants|||Number
76254|NCT01041404|Secondary|Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)|For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants||95% Confidence Interval|Number
76255|NCT01041404|Secondary|Time to Progression - Time to Event|The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||months||95% Confidence Interval|Median
76256|NCT01041404|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
76257|NCT01041404|Secondary|Progression-Free Survival - Time to Event|The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||months||95% Confidence Interval|Median
97598|NCT00835185|Secondary|Cmax at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Cmax results were not collected.|||||
76258|NCT01041404|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
76259|NCT01041404|Primary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS||percentage of participants|||Number
76260|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|6 months|||meters per second (m/s)||Standard Deviation|Mean
76261|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|3 months|||meters per second (m/s)||Standard Deviation|Mean
76262|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|Baseline|||meters per second (m/s)||Standard Deviation|Mean
76263|NCT01041209|Secondary|Treatment Failure in Each Group|"Treatment failure was defined as: Persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.~Proportion of patients with treatment failure was compared between both groups (BPS vs Guideline)."|1, 2, 5, 7 and 10 days from baseline|||participants|||Number
76264|NCT01041209|Primary|Use of Antibiotics in Each Group|The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).|At baseline|||participants|||Number
76265|NCT01040871|Secondary|Change in Fatigue and Patient Utility Scores||18-24 months||||||
76266|NCT01040871|Secondary|Overall Survival Rate at 1-year|Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.|1 year|Intent to Treat Population||percentage of partipants||95% Confidence Interval|Number
76267|NCT01040871|Secondary|Progression-free Survival (PFS)Rate at 1-year|Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death.|1 year|Intent to Treat Population||percentage of partipants||95% Confidence Interval|Number
76268|NCT01040871|Secondary|Subsequent Anti-lymphoma Therapy Rate at 1-year|Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive.|1 year|Intent to Treat Population||percentage of participants||95% Confidence Interval|Number
76269|NCT01040871|Secondary|Rate of Durable Complete Response|Proportion of subjects who achieved a CR with duration of at least 6 months|Median follow up approx 12 months|||percentage of participants||95% Confidence Interval|Number
76270|NCT01040871|Secondary|Rate of Durable Response|Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.|Median follow up approx. 12 months|||percentage of participants||95% Confidence Interval|Number
76271|NCT01040871|Secondary|Overall Response Rate|"Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment||percentage of participants||90% Confidence Interval|Number
76286|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Ethinyl Estradiol With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
84370|NCT00961805|Secondary|Quality of Life - SF-36 - Physical Limitation|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
76272|NCT01040871|Primary|Complete Response (CR) Rate|"Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PET scan was negative.~The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.~If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.~No new sites of disease were detected."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment||percentage of participants||90% Confidence Interval|Number
76273|NCT01040858|Secondary|Satisfaction With Life Scale|A brief measure of global life satisfaction. It measures the sum of satisfaction ratings for 5 items on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 5 to 35 with higher scores indicating greater satifaction.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76274|NCT01040858|Secondary|Severity of Dependence Scale|A brief substance dependence measure. It measures the sum of severity ratings for 5 symptoms on a scale from 0 (never) to 3 (always). The total score ranges from 0 15.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76275|NCT01040858|Secondary|Beck Depression Inventory, Second Edition|A depression symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severity ratings for 21 symptoms on a scale from 0 (none) to 3 (severe). BDI total score ranges from 0 to 63.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76276|NCT01040858|Secondary|PTSD Checklist-Military Version|A PTSD symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severit ratings for 17 symptoms on a scale from 1 (not at all) to 5 (extremely). PCL-M total score ranges from 17 to 85.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76277|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Verbal Fluency Subtest|A measure of verbal fluency, generativity, and processing speed. A scaled score of Letter Fluency portion of the test was used. The scores ranged from 0 to 20 with higher scores indicating better outcomes.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76278|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Trails Subtest|A visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Scaled score for Condition 4 was used, and possible scores ranges from 0 to 20 with higher scores indicating better outcome.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76279|NCT01040858|Secondary|Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest|A measure of attention and working memory. Total score was used, and it ranges from 0 to 48, with higher scores indicating greater attentional capacity.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76280|NCT01040858|Secondary|Hopkins Verbal Memory Test-Revised|Verbal list learning and delayed recall. Total recall T-score was used for the analyses. Total recall T-score ranges from 13 (severely impaired) to 86 (very superior).|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76281|NCT01040858|Secondary|Memory Compensation Questionnaire|The MCQ is a 44-item self-report questionnaire that rates the extent to which patients use various strategies to improve memory performance relevant to daily living. The MCQ measures the sum of memory strategies used on a scale from 0 (never) to 4 (always). The total score ranges from 0 to 176.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76282|NCT01040858|Secondary|The Neurobehavioral Symptom Inventory|A post-concussive symptom measure. The total score on the measure is the sum of severity ratings for 22 symptoms on a scale from 0 (none) to 4 (very severe). NSI total score ranges from 0 to 88.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76283|NCT01040858|Secondary|Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &|A 16-item self-report severity measure of prospective and retrospective memory problems relevant to everyday life. The measure reports the sum of severity ratings on a scale from 1 (never) to 5 (very often). The PRMQ total score ranges from 16 to 80.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76284|NCT01040858|Primary|Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version|A self-report measure of severity of attention and organizational problems. It measures the sum of severity ratings on a scale from 0 (never) to 4 (very often). The total score ranges from 0 to 64.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.||units on a scale||Standard Deviation|Mean
76285|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colchicine With Norethindrone/Ethinyl Estradiol|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
84371|NCT00961805|Secondary|Quality of Life - SF-36 -Functional Capacity|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
76287|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Ethinyl Estradiol With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng/mL||Standard Deviation|Mean
76288|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
76289|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng-hr/mL||Standard Deviation|Mean
76290|NCT01040845|Primary|Maximum Plasma Concentration of Colchicine With Norethindrone/Ethinyl Estradiol at Steady State (Cmax, ss)|The maximum or peak concentration that Colchicine with Norethindrone/Ethinyl Estradiol reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
76291|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
76292|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
76293|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
76294|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.|||ng/mL||Standard Deviation|Mean
76295|NCT01040832|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Time from first dose up to Day 42 to 49 after last dose of trial treatment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|Safety population included all the participants who received at least 1 dose study drug.||participants|||Number
76296|NCT01040832|Secondary|Overall Survival (OS) Time|The overall survival (OS) time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment. Overall survival data was analyzed only for participants who received cetuximab plus EMD 1201081.||months||95% Confidence Interval|Median
76297|NCT01040832|Secondary|Percentage of Participants With Disease Control: Independent Read Assessments|Percentage of participants with disease control, defined as having achieved CR or PR or stable disease (SD) as the tumor response according to radiological assessments (based on RECIST Version 1.0 criteria), was reported. As per RECIST v1.0 for target lesions and assessed by MRI: CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.||percentage of participants||95% Confidence Interval|Number
76476|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76298|NCT01040832|Secondary|Percentage of Participants With Objective Response: Independent Read Assessments|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as assessed by Independent Read. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.||percentage of participants||95% Confidence Interval|Number
76299|NCT01040832|Primary|Progression-free Survival (PFS) Time: Independent Read Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event were censored on the date of last tumor assessment.|Every 6 weeks until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.||months||95% Confidence Interval|Median
76300|NCT01040819|Primary|Plasma 15-epi-lipoxin A4|Plasma 15-epi-LXA4 levels|2 months|||ng/ml||Standard Error|Mean
76301|NCT01040793|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
76302|NCT01040793|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.||percentage of participants|||Number
76303|NCT01040793|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.||percentage of participants|||Number
76304|NCT01040793|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||beats/min||Standard Deviation|Mean
76305|NCT01040793|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||mmHg||Standard Deviation|Mean
76306|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
76307|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
76308|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76309|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76310|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76311|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76312|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76313|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76314|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76315|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76316|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76317|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76318|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
76319|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
76320|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76321|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76322|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.~Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
76323|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76324|NCT01040793|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||seconds||Standard Error|Geometric Mean
76325|NCT01040780|Secondary|Safety and Tolerability|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.~Grade 3 = Severe Grade 4 = Life-threatening or disabling"|Assessed over two years|||participants|||Number
76326|NCT01040780|Secondary|Time To Progression|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.|2-7 months|||months||95% Confidence Interval|Median
76327|NCT01040780|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression|||percentage of patients|||Number
76328|NCT01040780|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death|||months||95% Confidence Interval|Median
76329|NCT01040780|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|2-7 months|All patients who received at least one dose of study drug with measurable disease at baseline.||months||95% Confidence Interval|Median
76330|NCT01040728|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.||participants|||Number
76477|NCT01038752|Secondary|Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes|Insufficient data.|Randomization date|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76331|NCT01040728|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment for the first period. Trough values were the mean of obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76332|NCT01040728|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment for the first period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76333|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76334|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data for this endpoint after first dose of treatment.||Liter||Standard Error|Mean
76335|NCT01040728|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76336|NCT01040728|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76337|NCT01040728|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76338|NCT01040728|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment for the first period. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76339|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76340|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data for this endpoint after first dose of treatment.||Liter||Standard Error|Mean
76341|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76342|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the treatment at the first treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data for this endpoint after first dose of treatment.||Liter||Standard Error|Mean
76343|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose at the first randomized treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76344|NCT01040728|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76345|NCT01040728|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either of the co-primary endpoints. FAS including all patients with evaluable data for this endpoint after six weeks.||Liter||Standard Error|Mean
76346|NCT01040689|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.||percentage of participants|||Number
76347|NCT01040689|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose in first treatment period. Trough values were mean of the values obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76348|NCT01040689|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose in first treatment period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76349|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76350|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data after first dose of treatment.||Liter||Standard Error|Mean
76351|NCT01040689|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76352|NCT01040689|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76353|NCT01040689|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76354|NCT01040689|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of first treatment period. Trough values were the mean of values obtained 23 hours and 23h 50min post the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76355|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76356|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data after first dose of treatment.||Liter||Standard Error|Mean
76357|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76358|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data after first dose of treatment.||Liter||Standard Error|Mean
76385|NCT01040403|Secondary|FVC AUC 0-3h Response After First Dose|Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1|FAS||Litres||Standard Error|Mean
76359|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the first visit of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76360|NCT01040689|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76361|NCT01040689|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either co-primary endpoint from the same treatment period. FAS including all patients with evaluable data after six weeks.||Liter||Standard Error|Mean
76362|NCT01040624|Secondary|Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.||After radiation: every 6 months for 3 years, then annually for 20 years||||||
76363|NCT01040624|Secondary|Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.||After radiation: every 6 months for 3 years, then annually for 20 years||||||
76364|NCT01040624|Primary|Acute Grade 3 or Higher Treatment-related Toxicity Rate.|Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.|6 months after the completion of radiation therapy|||participants|||Number
76365|NCT01039519|Secondary|Count of Participants With Treatment-Emergent Adverse Events (AEs)|"Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.~Dose modification includes dose delay and dose reduction."|Day 1 up to Week 51|Full analysis set||participants|||Number
76366|NCT01039519|Secondary|Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)|PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999]. Tumor response was considered a complete response (CR) or a partial response (PR).|Day 2 to Day 10|Participants from one investigative site who provided consent for the PET/CT imaging.||percentage of participants|||Number
76367|NCT01039519|Secondary|Kaplan-Meier Estimate of Overall Survival|Overall survival was defined as the time from first dose to death or the date last known alive.|Day 1 up to week 97|Full analysis set||months||95% Confidence Interval|Median
76368|NCT01039519|Secondary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|"PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as~at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or~the appearance of 1 or more new lesions or~the unequivocal progression of existing nontarget lesions"|Day 1 up to Week 47|Full analysis set||months||95% Confidence Interval|Median
76369|NCT01039519|Secondary|Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0|"Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.~CR: disappearance of all target lesions and non-target lesions and no new lesions~PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set||percentage of participants|||Number
76386|NCT01040403|Secondary|FVC AUC 0-3h and FEV1 AUC 0-6h Responses|Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS||Litres||Standard Error|Mean
76370|NCT01039519|Primary|Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|"Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.~CR: disappearance of all target lesions and non-target lesions and no new lesions~PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set which included participants receiving at least one dose of study medication.||percentage of participants|||Number
76371|NCT01040403|Secondary|Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry|Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for systolic and diastolic blood pressure at baseline and day 29.||mmHg||Standard Deviation|Mean
76372|NCT01040403|Secondary|Pulse Rate Recorded in Conjunction With Spirometry|Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for pulse rate at baseline and day 29.||bpm||Standard Deviation|Mean
76373|NCT01040403|Secondary|Patients Global Rating|"Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29.~The score was evaluated on a 7-point scale :~1 : very much better~2 : much better~3 : a little better~4 : no change~5 : a little worse~6 : much worse~7 : very much worse"|Day 29|FAS||units on a scale||Standard Error|Mean
76374|NCT01040403|Secondary|Physicians Global Evaluation|"Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29.~The score was evaluated on a 8-points scale :~Poor : 1,2~Fair : 3,4~Good : 5,6~Excellent : 7,8"|Days 1 and 29|FAS||units on a scale||Standard Error|Mean
76375|NCT01040403|Secondary|Weekly Mean Number of Puffs of Rescue Medication Used Per Day|Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff).|Weeks 1 and 4|FAS||number of puffs per day||Standard Error|Mean
76376|NCT01040403|Secondary|Individual PEF Measurements at Each Time Point on Day 29|Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS||L/min||Standard Error|Mean
76377|NCT01040403|Secondary|Individual FVC Measurements at Each Time Point on Day 29|Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS||Litres||Standard Error|Mean
76378|NCT01040403|Secondary|Individual FEV1 Measurements at Each Time Point on Day 29|Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS||Litres||Standard Error|Mean
76379|NCT01040403|Secondary|PEF Peak 0-3h Response After the First Dose|Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||L/min||Standard Error|Mean
76380|NCT01040403|Secondary|PEF Peak 0-3h Response|Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS||L/min||Standard Error|Mean
76381|NCT01040403|Secondary|PEF AUC 0-3h Response After the First Dose|Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||L/min||Standard Error|Mean
76382|NCT01040403|Secondary|PEF AUC 0-3h and AUC 0-6h Responses|Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS||L/min||Standard Error|Mean
76383|NCT01040403|Secondary|FVC Peak 0-3h Response After the First Dose|Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||Litres||Standard Error|Mean
76384|NCT01040403|Secondary|FVC Peak 0-3h Response|Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS||Litres||Standard Error|Mean
76478|NCT01038752|Secondary|Pre-treatment bFGF Levels Correlation With Survival.|Insufficient data.|Before first treatment|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76387|NCT01040403|Secondary|FEV1 Peak 0-3h Response After the First Dose|Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||Litres||Standard Error|Mean
76388|NCT01040403|Secondary|FEV1 Peak 0-3h Response|Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS||Litres||Standard Error|Mean
76389|NCT01040403|Secondary|FEV1 AUC 0-3h Response After the First Dose|Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS||Litres||Standard Deviation|Mean
76390|NCT01040403|Secondary|FEV1 AUC 0-3h and FEV1 AUC 0-6h Response|Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS||Litres||Standard Deviation|Mean
76391|NCT01040403|Secondary|Trough Forced Vital Capacity (FVC) Response|Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|FAS which included all patients who were dispensed study medication and who provided baseline and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.||Litres||Standard Error|Mean
76392|NCT01040403|Primary|Trough FEV1 Response|Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|Full Analysis Set (FAS) which comprised all patients in the treated set who provided baseline (study baseline) data and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.||Litres||Standard Deviation|Mean
76393|NCT01040351|Secondary|The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .|The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .|18 weeks after embryo transfer|Patients who underwent embryo transfer were included in the final analysis||participents|||Number
76394|NCT01040351|Primary|The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle|"The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound~)in a transfer cycle"|5 weeks after embryo transfer|Patients undergoing embryo transfer were included in final analysis||participents|||Number
76395|NCT01040260|Primary|Abstinence Rate|Verified 7-Day Point-prevalence abstinence rate|52 weeks|||participants|||Number
76396|NCT01040260|Primary|Abstinence From Tobacco Use||52 weeks||||||
76397|NCT01040208|Secondary|The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.||participants|||Number
76398|NCT01040208|Secondary|The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.||participants|||Number
76399|NCT01040208|Primary|The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.||17 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.||participants|||Number
76400|NCT01040169|Primary|Tooth Hypersensivity Stimuli to Air|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|12 weeks (Final)|||Units on a scale||Standard Deviation|Mean
76401|NCT01040169|Primary|Tooth Hypersensitity to Touch Stimuli (Tactile)|Units on a scale:Measured with an electronic force sensing probe(Yeaple Probe):10, 20, 30, 40,up to 50 grams of force are applied to hypersensitive tooth until pain is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity|12 weeks (Final)|||Units on a scale||Standard Deviation|Mean
76479|NCT01038752|Secondary|Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.|Insufficient data.|Day 1 of each cycle; end of treatment visit; at follow-up.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76405|NCT01040130|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||beats/min||Standard Deviation|Mean
76406|NCT01040130|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.||mmHg||Standard Deviation|Mean
76407|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
76408|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters/second||Standard Error|Least Squares Mean
76409|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76410|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76411|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76412|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76413|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76414|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76415|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76416|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76417|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76418|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76419|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
76420|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||Scores on a scale||Standard Error|Least Squares Mean
76480|NCT01038752|Secondary|Overall Response Rate (Complete Response + Partial Response) of Participants|Insufficient data|Tumor assessment at every other cycle|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76421|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76422|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76423|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.~Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||Scores on a scale||Standard Error|Least Squares Mean
76424|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.||liters||Standard Error|Least Squares Mean
76425|NCT01040130|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.||seconds||Standard Error|Geometric Mean
76426|NCT01040052|Primary|Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine|Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
76427|NCT01039675|Secondary|Change From Baseline in Maximum and Minimum Pulse Rate 0 to 6 Hours Post-dose on Days 1, 14, and 28|Pulse rate is defined as the number of heartbeats in a minute (m). A maximum post-Baseline pulse rate was derived as the maximum value recorded at Days 1, 14 and 28. A minimum post-Baseline pulse rate was derived as the minimum value recorded at Days 1, 14 and 28. The maximum and minimum pulse rates were calculated using the 0 to 6 hours (h) post dose measurements on Days 1, 14 and 28, which included pre-dose, and post-dose 15 m, 45 m, 1.5 h, 3 h and 6 h. Maximum and minimum post-Baseline rate were calculated using the nominal 0-6 h post-dose records, and only records collected during the actual 0-7 h post-dose interval were used. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the maximum or minimum pulse rate minus the Baseline value. Analysis performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, Day 14 and Day 28|ITT Population. The overall number of participants presented is the number who provided at least one post-Baseline assessment of 0-6 hours maximum or minimum pulse rate. Those participants who provided data at the indicated time point are represented by n=X, X in the category titles.||Beats per minutes||Standard Error|Least Squares Mean
76428|NCT01039675|Secondary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 1 and Day 14|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements on Day 1 and Day 14, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 1 or Day 14 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, and Day 14|ITT Population. All participants with >=1 post-BL assessment are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.||Beats per minutes||Standard Error|Least Squares Mean
76429|NCT01039675|Primary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements at Day 28, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 28 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline and Day 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >= 1 dose of randomized study medication. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 28.||Beats per minutes (bpm)||Standard Error|Least Squares Mean
76430|NCT01039584|Secondary|Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth)|Visit 3: Day 22-31|||participants|||Number
76431|NCT01039584|Secondary|Clinical Cure|"Clinical cure (clinical success) was defined as follows:~All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure~A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure)~The subject did not require additional vulvovaginal or systemic antifungal therapy~The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products"|Visit 3: Day 22-31|per-protocol||participants|||Number
76432|NCT01039584|Primary|The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.|Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)|Visit 3: Day 22-31|per-protocol||participants|||Number
76433|NCT01039428|Secondary|Serum Intact Fibroblast Growth Factor (FGF) 23 Level|Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||log10(pg/mL)||Standard Deviation|Mean
76434|NCT01039428|Secondary|Serum Intact Parathyroid Hormone (PTH) Level|Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||pg/mL||Standard Deviation|Mean
76435|NCT01039428|Secondary|Ca×P|Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/mL*mg/mL||Standard Deviation|Mean
76436|NCT01039428|Secondary|Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL])|Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
76437|NCT01039428|Secondary|Salivary Inorganic Phosphorus Level|Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
76438|NCT01039428|Secondary|Serum Inorganic Phosphorus Level|Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
76439|NCT01039428|Secondary|Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P＜5.5 mg/dL at Week 3||week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.||participants|||Number
76440|NCT01039428|Secondary|Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL||baseline and end of the treatment|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.||participants|||Number
76441|NCT01039428|Primary|Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline|Change in serum inorganic phosphorus at the end of treatment from baseline|baseline and end of the chewing treatment during three week treatment period|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.||mg/dL||Standard Deviation|Mean
76442|NCT01039376|Secondary|Plasma Half-life (t1/2) of Ofatumumab|The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
76443|NCT01039376|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.|Day 1 Month 1 ( Cycle 1) through Month 25 ( Cycle 13)|PK Population. Only those participants available at the indicated time points were analyzed.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
76444|NCT01039376|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of the drug exposure over time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||micrograms*hour per mL (µg*hour/mL)||Geometric Coefficient of Variation|Geometric Mean
76445|NCT01039376|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||millileters per hour (mL/hour)||Geometric Coefficient of Variation|Geometric Mean
76481|NCT01038752|Secondary|Overall Survival of Participants|Insufficient Data|First treatment date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76446|NCT01039376|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
76447|NCT01039376|Secondary|Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers|Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=CY G.|From Baseline until the end of the study (up to 84 months)|ITT Population||Participants|||Number
76448|NCT01039376|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every two months from Month 3 until Month 25 and at every follow-up visit (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Cells per microliter||Standard Deviation|Mean
76449|NCT01039376|Secondary|Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.|From randomization until the end of the study (up to 84 months)|ITT Population. Only those participants with data available at the specified time point were analyzed.||Participants|||Number
76450|NCT01039376|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value. Immunoglobulins were measured at the following time points: Baseline (BL) and Cycle (C) 2 Week (W) 9/Month (M) 3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL) were presented.|Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 24 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||grams per liter||Standard Deviation|Mean
76451|NCT01039376|Secondary|Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result|All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.|Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.||Participants|||Number
76452|NCT01039376|Secondary|Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From randomization until the end of the study (up to 24 months)|Safety Population||Participants|||Number
76453|NCT01039376|Secondary|Number of Participants Who Received at Least One Transfusion During the Study|Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.|From randomization until the end of the study (up to 24 months)|Safety Population||Participants|||Number
76460|NCT01039376|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from poor (worse quality of life) to excellent (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA."|From randomization until the end of the study (up to 84 months)|ITT Population||Scores on a scale||Standard Deviation|Mean
76454|NCT01039376|Secondary|Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points|Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia [low hemoglobin count], neutropenia [low neutrophil count], and thrombocytopenia [low platelet count]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death). Assessment was at the following time points: Screening, C1 W1/M1, C1 W2/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C5 unscheduled, C6 W41/M11, C6 unscheduled, C7 W49/M13, C8 W57/M15, C8 unscheduled, C9 W65/M17, C10 W73/M19, C11 W81/M21,C11 unscheduled, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M FU and WDL.|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months)|Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
76455|NCT01039376|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months for non-serious AEs and 84 months for SAEs)|Safety Population||Participants|||Number
76456|NCT01039376|Secondary|Number of Participants With Grade 3 and Above Adverse Event of Infection|Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 84 months)|Safety Population: all participants who were randomized in the study and analyses were done based on the treatment the participant received regardless of how they were randomized.||Participants|||Number
76457|NCT01039376|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points|Par. with the indicated constitutional or B-symptoms (night sweats [without signs of infection]; unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of > 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of par. with no night sweats, no weight loss, no fever and no extreme fatigue were summarized and compared to the proportion of par. with >= 1 of the following: night sweats, weight loss, fever or extreme fatigue. The proportions were compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). B-symptoms were assessed at the following time points: Screening, C1 W1/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M, 15M, 18M, 21M FU and WDL.|From Screening until the end of the study (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.||Participants|||Number
76458|NCT01039376|Secondary|Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points|Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). The proportion of participants with improvement was compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). Improvement in ECOG performance status was measured at the available time points that have data: Cycle (C) 1 Week (W) 2/Month (M) 1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL).|From randomization until the end of the study (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
76459|NCT01039376|Secondary|Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.|From randomization until the end of the study (up to 84 months)|ITT Population||Scores on a scale||Standard Deviation|Mean
76474|NCT01038869|Primary|Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)|IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.|Baseline to 16 weeks|Per protocol||percentage of participants|||Number
76475|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76461|NCT01039376|Secondary|Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) – and single-item scales (social activities [Social Problems (SP) Scale] and future health worries [Future Health (FH) Scale]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).|From randomization until the end of the study (up to 84 months)|ITT Population||Scores on a scale||Standard Deviation|Mean
76462|NCT01039376|Secondary|Time to Progression After Next-line Therapy|Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.|From randomization until progression or death (up to 84 months)|ITT Population. Only participants who received next-line therapy and who also had PD prior to next line therapy were analysed. Participants who died prior to next-line therapy were also included for analysis.||Months||95% Confidence Interval|Median
76463|NCT01039376|Secondary|Progression-free Survival After Next-line Therapy|Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.|From randomization until progression or death (up to 84 months)|ITT Population. Only participants who received next-line therapy and subjects who died prior to receiving next-line therapy were analyzed.||Months||95% Confidence Interval|Median
76464|NCT01039376|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.|From randomization until the end of the study (up to 84 months)|ITT Population||Months||95% Confidence Interval|Median
76465|NCT01039376|Secondary|Number of Participants With Improvement in Response From Baseline|Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.|From Baseline until the end of the study (up to 24 months)|ITT Population. Only participants who had PR at study entry were analyzed.||Participants|||Number
76466|NCT01039376|Secondary|Overall Survival|Overall survival is defined as time from randomization to date of death.|From randomization until death (up to 84 months)|ITT Population||Months||95% Confidence Interval|Median
76467|NCT01039376|Primary|Progression-free Survival, as Assessed by the Independent Review Committee (IRC)|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 84 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.||Months||95% Confidence Interval|Median
76468|NCT01039376|Primary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 84 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.||Months||95% Confidence Interval|Median
76469|NCT01038921|Primary|Metabolic Syndrome Components||3 years|||mmHg||Standard Deviation|Mean
76470|NCT01038869|Secondary|Tolerability Assessments as Measured by the Number of Participants With Side Effects|Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus|16 weeks|per protocol||participants|||Number
76471|NCT01038869|Secondary|Percentage Change in Total Lesion Counts|Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).|Baseline to 16 weeks|per protocol||percentage of total lesion count||Standard Deviation|Mean
76472|NCT01038869|Secondary|Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution|The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%|Baseline to 16 weeks|per protocol||percentage of participants|||Number
76473|NCT01038869|Secondary|Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)|IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement|Baseline to16 weeks|per protocol||percentage of participants|||Number
84372|NCT00961805|Secondary|Quality of Life - Fibromyalgia Impact Questionnaire|score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
76482|NCT01038752|Primary|Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria|Insufficient data|Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.|||||
76483|NCT01038713|Secondary|Assess Rate of Acute Cholecystitis Associated With Each Type of Stent||time from stent placement to 500 days|||Participants|||Number
76484|NCT01038713|Secondary|Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents|Total number of days in which neoadjuvant therapy was delayed due to stent related issues|Time from stent placement to 500 days|||Days|||Number
76485|NCT01038713|Secondary|Determine the Days of Hospitalization Following Stent Placement|Number of total days of hospitalization for all patients in each group|From stent placement up to 500 days post stent|||Days|||Number
76486|NCT01038713|Secondary|Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.||Costs measured up to 500 days|||United States Dollars|||Number
76487|NCT01038713|Primary|Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction.|Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement|Time of stent occlusion, attempted surgical resection or patient death to 300 days|||participants|||Number
76488|NCT01038635|Secondary|Overall Response: Number of Participants With CR or CRi Response|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months|||participants|||Number
76489|NCT01038635|Secondary|Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months|||percentage of participants|||Number
76490|NCT01038635|Primary|Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)|DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.|3-8 week cycles, up to 24 weeks|||participants|||Number
76491|NCT01038609|Secondary|Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L.|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
76492|NCT01038609|Secondary|Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate <10 respirations per minute (rpm) (low) or >24 rpm (high).|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
76493|NCT01038609|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
76494|NCT01038609|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||minutes||95% Confidence Interval|Median
76596|NCT01036321|Secondary|Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||nmol/L||Full Range|Median
76495|NCT01038609|Secondary|Participant's Global Assessment of Study Drug|The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||participants|||Number
76496|NCT01038609|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||scores on a scale||Standard Error|Least Squares Mean
76497|NCT01038609|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).||scores on a scale||Standard Error|Least Squares Mean
76498|NCT01038336|Secondary|Change in Cues to Action Score|Cues to action is a construct from the Health Belief Model defined as external influences that promote a health behavior (e.g. symptoms, media communications, or information from a healthcare provider). In the current study it refers to prompts from others about protecting hearing. Cues to action was assessed with 2 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater cues to action, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Cues to action was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating more Cues to action having been received at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
76499|NCT01038336|Secondary|Change in Perceived Self-efficacy Score|Perceived Self-efficacy is a construct from the Health Belief Model defined as an individual's assessment of his/her ability to successfully adopt a health behavior. In the current study it assesses the extent to which the individual believes that he/she has the knowledge and abilities to protect hearing. Perceived Self-efficacy was assessed with 4 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived self-efficacy, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Self-efficacy was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived self-efficacy at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
76500|NCT01038336|Secondary|Change in Perceived Barriers Score|Perceived Barriers is a construct from the Health Belief Model defined as an individual's assessment of the influences that discourage adoption of a health behavior. In the current study it assesses the extent to which the individual perceives few negative influences to protecting hearing. Perceived Barriers was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating fewer perceived barriers, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Barriers was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating fewer perceived barriers at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
76501|NCT01038336|Secondary|Change in Perceived Benefit Score|Perceived Benefit is a construct from the Health Belief Model defined as an individual's assessment of the positive consequences of adopting a health behavior. In the present study that is the belief that hearing well is important. Perceived Benefit was assessed with 7 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived benefit, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived benefit was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived benefit at follow-up.|Baseline and 1 month|||units on scale||Standard Deviation|Mean
76502|NCT01038336|Secondary|Change in Perceived Severity Score|Perceived Severity is a construct from the Health Belief Model defined as an individual's assessment of the seriousness of the consequences of a condition if it is acquired. In the current study it assesses the extent to which the individual believes that a hearing loss would have negative consequences. Perceived Severity was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived severity, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Severity was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived severity at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
76521|NCT01037244|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
76503|NCT01038336|Secondary|Change in Perceived Susceptibility Score|Perceived Susceptibility is a construct from the Health Belief Model defined as an individual's assessment of the risk of acquiring a condition. In the current study it assesses the extent to which the individual feels vulnerable to hearing loss. Perceived Susceptibility was assessed with 5 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived susceptibility, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Susceptibility was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived susceptibility at follow-up.|Baseline and 1 month|||Units on a scale||Standard Deviation|Mean
76504|NCT01038336|Secondary|Knowledge About Hearing Conservation Scale|Knowledge about hearing conservation was assessed with 16 items in the the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). It is a validated questionnaire that assesses knowledge about and attitudes toward hearing and hearing loss prevention. The Knowledge scale is scored as a percent correct, with a higher score indicating more knowledge. Data presented are for change in knowledge between baseline and 1-month follow-up computed such that a higher score indicates greater increase in knowledge.|Baseline and 1 month|||percent of correct answers||Standard Deviation|Mean
76505|NCT01038336|Primary|Percentage of Time Spent at Sound Levels >80 Decibels|Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels >80 decibels|1 month|||percentage of time||Standard Deviation|Mean
76506|NCT01038323|Secondary|Change in Evoked Pain Scores|0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli|Baseline and Week 21 clinic visits|||units on a scale||Standard Error|Mean
76507|NCT01038323|Primary|Change in Weekly Average Pain Intensity|self report weekly average pain intensity score|Baseline and Week 21clinic visits|||units on a scale||Standard Error|Mean
76508|NCT01038128|Primary|Brown Assessments of Belief Scale|The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.|Baseline to 12 weeks|This scale was only administered to participants with Body Dysmorphic Disorder. No participants with BDD completed the Baseline Visit and, therefore, no results were available to analyze.|||||
76509|NCT01038128|Primary|Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale|The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||units on a scale||Standard Deviation|Mean
76510|NCT01038128|Primary|Clinical Global Impression Scale|Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||units on a scale||Standard Deviation|Mean
76511|NCT01038128|Primary|Ratings of Eating Pathology|"Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number 777 was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes."|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||units on a scale||Standard Deviation|Mean
76512|NCT01038128|Primary|Number of Binge Eating and Self-induced Vomiting Episodes|Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.||number of episodes||Standard Deviation|Mean
76513|NCT01037452|Secondary|Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.||1 day|||participants|||Number
76514|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day|||millimeters||95% Confidence Interval|Mean
76515|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day|||millimeters||95% Confidence Interval|Mean
76516|NCT01037452|Primary|Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal|Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.|1 day|||participants||95% Confidence Interval|Number
76517|NCT01037309|Primary|Determine the Pharmacokinetics of PRO044||During the 5 weeks of treatment and during the 13 weeks after treatment||||||
76518|NCT01037309|Primary|Safety and Tolerability of PRO044|number of subjects with 1 or more treatment emergent adverse events following SC or IV PRO044|During the 5 weeks of treatment and during the 13 weeks after treatment|||participants|||Number
76519|NCT01037309|Primary|Increase in Dystrophin Expression in the Muscle Biopsies by Immunofluorescence Analyses of Cross-sections and by Western Blot Analyses of Total Protein Extracts||Within 13 weeks after 5 weeks of treatment|For some participants it was not possible to determine dystrophin expression in muscle biopsy||participants|||Number
76520|NCT01037244|Primary|Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
76597|NCT01036321|Secondary|Biomarkers of Disease Progression - IGF-1|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||ng/mL||Full Range|Median
76522|NCT01037244|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
76523|NCT01037244|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
76524|NCT01037244|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
76525|NCT01037244|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
76526|NCT01037244|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0 (poor) - 5/(good) scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
76527|NCT01037244|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
76528|NCT01037244|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population|EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use? How satisfied w/how quickly it works? How long it lasts? How confident made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline to Week 12|mITT Population||units on a scale||95% Confidence Interval|Least Squares Mean
76529|NCT01037244|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)|Baseline to Week 12|mITT Population||units on a scale||95% Confidence Interval|Least Squares Mean
76530|NCT01037244|Secondary|Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population||Week 12|mITT Population||participants|||Number
76531|NCT01037244|Primary|Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
76532|NCT01037244|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)||units on a scale||95% Confidence Interval|Least Squares Mean
76533|NCT01037218|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
76534|NCT01037218|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
76535|NCT01037218|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
76536|NCT01037218|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity|Baseline and Week 12|mITT||Units on a Scale||95% Confidence Interval|Least Squares Mean
76537|NCT01037218|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT|EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
76538|NCT01037218|Secondary|Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population|While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)|Week 12|mITT||Yes Responders|||Number
76539|NCT01037218|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
76540|NCT01037218|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
76541|NCT01037218|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
76542|NCT01037218|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
76543|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage of Yes Responses||95% Confidence Interval|Least Squares Mean
76544|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT||Percentage of Yes Reponses||95% Confidence Interval|Least Squares Mean
76545|NCT01037218|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|mITT, LOCF||Units on a Scale||95% Confidence Interval|Least Squares Mean
76546|NCT01037192|Secondary|Microbiological Efficacy|Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.|5 days|||participants|||Number
76547|NCT01037192|Primary|Clinical Efficacy|Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (> 15%) in leukocytes.|5 days|||participants|Participants||Number
76548|NCT01037127|Secondary|Number of Participants With Tumor Progression|Tumor progression was assessed as disease progression (DP), defined as at least a 20 percent increase in the sum of diameters of target lesions (representative of all involved organs), taking as reference the smallest sum on study; unequivocal progression of non-target lesions; or the appearance of a new lesion. Because melanoma often progresses to the brain/central nervous system (CNS) and this study enrolled approximately 20% participants with prior brain metastases, tumor progression in the brain/CNS was summarized. Paticipants could have been included in more than one category.|Baseline (Day 1) until tumor progression (up to approximately 57 weeks)|All Treated Population||Participants|||Number
76598|NCT01036321|Secondary|Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||mg/L||Full Range|Median
76549|NCT01037127|Secondary|Number of Participants Who Survived Until 6 Months, 12 Months and 24 Months From Baseline|Overall survival (defined as the time from the treatment start date until death due to any cause) data data are presented as the number of participants who were alive 6 months, 12 months and 24 months after Baseline. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Month 6, Month 12 and Month 24|All Treated Population||Participants|||Number
76550|NCT01037127|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until death due to any cause (up to 134 weeks)|All Treated Population||Months||95% Confidence Interval|Median
76551|NCT01037127|Secondary|PFS in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|PFS was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Per RECIST version 1.1, PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred earliest. Brain metastasis is a cancer that has spread to the brain from another location of the body.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because this subgroup was stopped for futility and nearly all the participants progressed before 4 months.||Months||95% Confidence Interval|Median
76552|NCT01037127|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred first. Participants who had not progressed or died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population||Months||95% Confidence Interval|Median
76553|NCT01037127|Secondary|Duration of Tumor Response|Duration of tumor response is defined as the time from the first documented evidence of a CR or PR to disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause. No participants who were previously treated with BRAF inhibitors had a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions; thus, no duration of response data can be presented.|From the time of the first documented evidence of a confirmed CR or PR until disease progression or death due to any cause (up to approximately 40 weeks)|All Treated Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
76554|NCT01037127|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. AE and serious AE (SAE) data were collected from the start of the investigational product and continued until the End of Treatment Visit. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study medication until 28 days after the last dose (up to 477 days)|All Treated Population||Participants|||Number
76555|NCT01037127|Secondary|Mean Plasma Concentrations|Human plasma samples were analyzed for trametinib using a validated analytical method.|Day 15, pre-dose, 0.5-2 hours (hrs) post-dose, 2-4 hrs post-dose, and 4-8 hrs post-dose; Week 4, pre-dose; Week 8, pre-dose; Week 12, pre-dose|Pharmacokinetic (PK) Population: all participants in the All Treated Population for whom PK samples were obtained and analyzed. Only those participants available at the indicated time points were analyzed.||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
76556|NCT01037127|Primary|Number of Participants With Best Unconfirmed Response at the Time of the Interim Analysis (Week 8)|An interim analysis was performed using data collected approximately 12 and 13 weeks after the 30th participant was enrolled in the prior BRAF inhibitor and prior standard therapy groups, respectively. The best unconfirmed response by the investigator per RECIST version 1.1 was assessed. The study design permitted stopping the study for futility if <3 best confirmed responses were observed in the first 30 participants of each treatment arm after completing the first post-dose assessment at Week 8. Best response was measured as either a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions.|Week 8|All Treated Population||Participants|||Number
76565|NCT01037114|Secondary|Anti-HAV Concentrations After the Challenge Dose of Havrix.|Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.|Before, 14 days and one month (30 days) after the challenge dose of Havrix|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.||mIU/mL|||Number
76566|NCT01037114|Secondary|Anti-HBs Concentrations After the Challenge Dose of Engerix-B|"Concentration was given in mIU/mL.~Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion."|Before, 14 days and one month (30 days) after the challenge dose of Engerix-B|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.||mIU/mL|||Number
76557|NCT01037127|Primary|Number of Participants With Best Confirmed Response in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|The number of participants with best confirmed response was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Objective response was assessed per RECIST version 1.1. Objective response was measured either as CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 mm, or PR, defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met. Brain metastasis is a cancer that has spread to the brain from another location of the body.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed CR or PR (up to approximately 25 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because there were no CRs or PRs among these participants.||Participants|||Number
76558|NCT01037127|Primary|Number of Participants With Best Confirmed Response|Best confirmed response was assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Best response was measured either as a complete response (CR), defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters (mm), or a partial response (PR), defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed complete response or partial response (up to approximately 25 weeks)|All Treated Population: all participants who received at least one dose of investigational product||Participants|||Number
76559|NCT01037114|Secondary|Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication.|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to Year 20.|The LT Total cohort included all subjects who returned at each annual time point and who belonged to the Total cohort in the primary study.||Subjects|||Number
76560|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"One subject received a challenge dose of Havrix at Year 18 and another at Year 20.~Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|During the 31-day (Days 0-30) follow-up period after the Havrix™ challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.||subjects|||Number
76561|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Only 1 subject received a challenge dose at Year 16 of Engerix-B.~An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the 31-day (Days 0-30) follow-up period after the Engerix™-B challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.||Subjects|||Number
76562|NCT01037114|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"At Year 16, 1 subject was administered a challenge dose of Engerix™-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix™.~An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine or Havrix.||Subjects|||Number
76563|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix|"Anti-HAV anamnestic response to the challenge dose was defined as:~Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point.~At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point.~Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point."|30 days after the challenge dose of Havrix|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.||subjects|||Number
76564|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B|"At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B.~Anti-HBs anamnestic response to the challenge dose was defined as:~Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point.~At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point."|30 days after the challenge dose of Engerix-B|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.||Subjects|||Number
76586|NCT01036529|Primary|Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment||3, 6- and 12- months post-index procedure|||proportion of participants|||Number
76567|NCT01037114|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
76568|NCT01037114|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.||Subjects|||Number
76569|NCT01037088|Primary|Participants With 30% or Greater Reduction in Pain Intensity|The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.|baseline to six hours|This was a cross over study. Ten of the 38 subjects who were exposed to placebo had a 30% reduction in pain intensity as compared to 21 of the 37 exposed to the low dose and 22 of the 36 receiving the medium dose of cannabis.||percentage of participants||95% Confidence Interval|Number
76570|NCT01036802|Secondary|Major and Minor Bleeding Complications|We evaluated the safety of warfarin by evaluating for major and minor bleeding complications in study subjects|Evaluations were obtained at Screening, and at Months 3, 6, 9, and 12|||participants|||Number
76571|NCT01036802|Secondary|All-cause Mortality|We assessed the effect of warfarin on mortality in the study subjects|Assessment was obtained until completion of study at 12 months|||participants|||Number
76572|NCT01036802|Secondary|Endothelial Activation|We assessed the effect of warfarin on plasma measures of endothelial activation (soluble vascular cell adhesion molecule-1)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|As the number of subjects studied were very few, requiring discontinuation of the study, evaluation of endothelial activation was not performed.|||||
76573|NCT01036802|Secondary|Platelet Activation|We evaluated the effect of anticoagulation with warfarin on platelet activation assessed by measuring plasma levels of soluble CD40 ligand|Measurements were obtained at Screening, Prior to Run-in, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.|||||
76574|NCT01036802|Secondary|Thrombin Generation|We evaluated the effect of warfarin on a plasma measure of thrombin generation (thrombin-antithrombin complex)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.|||||
76575|NCT01036802|Secondary|6-minute Walk Test|We evaluated the distance walked over 6 minutes. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, Months 3, 6, 9, and 12|||feet||Full Range|Mean
76576|NCT01036802|Primary|Effect of Anticoagulation on Pulmonary Artery Systolic Pressure Was Obtained by Doppler Echocardiography|We determined the effect of anticoagulation with warfarin on estimated pulmonary artery systolic pressure obtained by Doppler echocardiography. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|||mm Hg||Full Range|Mean
76577|NCT01036763|Secondary|Physician's Global Evaluation at Visit 2|Physician’s global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6–12 weeks of treatment with Spiriva.|after 6 - 12 weeks|||Participants|||Number
76578|NCT01036763|Secondary|Physician's Global Evaluation at Visit 1|Physician’s global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores “Poor (1, 2)”, “Satisfactory (3, 4)”, “Good (5, 6)” and “Excellent (7, 8)” prior to treatment with Spiriva.|0 weeks|||Participants|||Number
76579|NCT01036763|Primary|Assessment of Tolerability According to Patient|Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks|||Participants|||Number
76580|NCT01036763|Primary|Assessment of Efficacy According to Patient|patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks|||Participants|||Number
76581|NCT01036763|Primary|Assessment of Tolerability According to Physician|Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks|||Participants|||Number
76582|NCT01036763|Primary|Assessment of Efficacy According to Physician|Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks|||Participants|||Number
76583|NCT01036763|Primary|Success of Treatment With Tiotropium According to Physician's Assessment|Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful|6 - 12 weeks|All patients who were documented to have taken at least one dose of Spiriva®18 Microgram/Spiriva® Respimat® and had COPD requiring long-acting anticholinergics||Participants|||Number
76584|NCT01036724|Secondary|Total Procedure Time||Total Duration of the Procedure|||minutes||Full Range|Median
76585|NCT01036724|Primary|Total Fluoroscopy Time|The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures.|Throughout the Total Duration of the Procedure|||minutes||Full Range|Median
76599|NCT01036321|Secondary|Biomarkers of Disease Progression - Free Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||pg/ml||Full Range|Median
76600|NCT01036321|Secondary|Biomarkers of Disease Progression - Estradiol|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.||pmo/L||Full Range|Median
76601|NCT01036321|Secondary|Change in Plasma Concentrations of Isoflavone|Plasma concentrations of isoflavone: Genistein from baseline to post intervention by study arm.|Up to 6 weeks|All participants who were randomized to a study arm.||mg||Full Range|Median
76602|NCT01036321|Secondary|Biomarkers of Disease Progression - Serum PSA|Median change from baseline to post intervention: Prostatic specific antigen (PSA). All Participants (ALL); Caucasian Men only (CM only); African American Men only (AAM only).|Up to 6 weeks|All participants who were randomized to a study arm.||ng/mL||Full Range|Median
76603|NCT01036321|Primary|Number of Toxicity Events by Final Attribution and Treatment Arm|Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.|Up to 6 weeks|All participants who were randomized to a study arm.||Toxicity Events|||Number
76604|NCT01036321|Primary|Median Change in Percent Ki-67 From Baseline|Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.|Baseline to post intervention - up to 6 weeks|All participants who were randomized to a study arm.||percentage of tumor cells||Full Range|Median
76605|NCT01036165|Secondary|Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.|The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at Week 12|||Percentage of subjects||95% Confidence Interval|Mean
76606|NCT01036165|Primary|The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as ‘Easy to Use’ or ‘Very Easy to Use’ for Self-injection in a User Trial Questionnaire.|Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 Weeks|||Proportion of subjects||95% Confidence Interval|Mean
76607|NCT01036009|Post-Hoc|Time Until Late Relapse|Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as >5% blasts in bone marrow|24-36 months post-transplant|intervention patients who relapsed after the 2 year primary study endpoint||months||Full Range|Mean
76608|NCT01036009|Post-Hoc|Late Relapses|The number of patients who relapsed after 2-year primary endpoint. To assess a potential for late relapse-rate in the intervention arm only, patients in the intervention arm were provided additional follow-up until 3-yrs post transplant. The criterion for relapse was >5% blasts in bone marrow.|24-36 months post-transplant|surviving patients in the intervention arm who had not relapsed as of 24 months were followed for an additional 12 months (until 3 years post-transplant)||participants|||Number
76609|NCT01036009|Secondary|The Incidence of Chronic GVHD (cGVHD).|"Diagnostic criteria of cGVHD from: Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host disease: I Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 2005;11:945-955.~The diagnosis of chronic GVHD requires the following:~1) Distinction from acute GVHD; 2) Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests; 3) Exclusion of other possible diagnoses.~Scoring of organ manifestations requires careful assessment of signs, symptoms, laboratory values, and other study results. A clinical scoring system (0-3) is used for evaluation of the involvement of individual organs and sites. Global assessment of severity (mild, moderate, or severe) is derived by combining organ- and site-specific scores."|2 years post transplant|||participants|||Number
76610|NCT01036009|Secondary|The Incidence of Acute Graft Versus Host Disease (aGVHD).|"Definition and diagnostic criteria of aGVHD according to: 1994 Consensus Conference on Acute GVHD Grading. Przepiorka D1, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. Bone Marrow Transplant. 1995 Jun;15(6):825-8.~In this system, patients are divided into one of four grades (I-IV) depending on the degree, or stage, of involvement in three organs. The skin is staged with percent body surface involved, the liver is staged with degree of bilirubin elevation, and the gastrointestinal tract is staged with amount of diarrhea."|2 years post transplant|||participants|||Number
76611|NCT01036009|Secondary|2 Years Post-transplant Survival.||2 years post transplant|||participants|||Number
76612|NCT01036009|Primary|Relapse at 2 Years Post-transplant.|Definition of relapse was >5 % blasts in bone marrow|2 years post transplant.|||participants|||Number
76613|NCT01035944|Secondary|Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting.||2 days and 5 days after debridement.||||||
76614|NCT01035944|Primary|Demonstrate That Debridements Using HemCon Dressings at Bedside Can be Performed Safely Without Excessive Bleeding; Compare Levels of Bacterial Load Between Debrided Wounds Treated With HemCon Dressings vs. Wounds Treated With Gauze & Saline Dressings.||2 days and 5 days after debridement.|Zero participant data were analyzed. Study was terminated early; unable to reach enrollment milestones.|||||
76615|NCT01035905|Primary|Lens Awareness|Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week’s wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.|4 weeks of wear|Per Protocol||Participants|||Number
84373|NCT00961805|Secondary|Function - 6 Minute Walk Test|meters traveled on a 20-meter course over a six-minute period|baseline, after 16 weeks and after 32 weeks|||meters||Standard Deviation|Mean
76616|NCT01035788|Primary|Clinician-Administered PTSD Scale (CAPS)|The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.|treatment end (approximately 10 weeks after session 1 of the interventions)|This analysis was intention to treat and included the 30 participants of the original 34 who completed the CAPS interview at treatment end.||units on a scale||95% Confidence Interval|Least Squares Mean
76617|NCT01035749|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 364)|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
76618|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 21-day (Days 0-20) follow-up period after booster vaccination.|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study."||Subjects|||Number
76619|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 42-day (Days 0-41) follow up period after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
76620|NCT01035749|Secondary|Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges|Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).|At Days 0, 21, 42, 182 and 189|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study at Days 182 and 189."||Subjects|||Number
76621|NCT01035749|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-364) following first vaccination|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
76622|NCT01035749|Secondary|Number of Subjects Reporting Any Medically Attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (Days 0-364) following the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
76623|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following booster dose|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study."||Subjects|||Number
76624|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
76625|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity|During the 7-day (Days 0-6) post-vaccination period following booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
76626|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
76637|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titers were expressed as GMTs.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.||Titers||95% Confidence Interval|Mean
76627|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Fold increase||95% Confidence Interval|Geometric Mean
76628|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Fold increase||95% Confidence Interval|Geometric Mean
76629|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Fold increase||95% Confidence Interval|Geometric Mean
76630|NCT01035749|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.||Fold increase||95% Confidence Interval|Geometric Mean
76631|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, Day 182 and Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Subjects|||Number
76632|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Subjects|||Number
76633|NCT01035749|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available||Subjects|||Number
76634|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Subjects|||Number
76635|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Subjects|||Number
76636|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Subjects|||Number
76653|NCT01035346|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||percentage of participants|||Number
76638|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available||Subjects|||Number
76639|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Days 0, 182 and 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available||Titers||95% Confidence Interval|Geometric Mean
76640|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as GMTs.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available||Titers||95% Confidence Interval|Geometric Mean
76641|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.||Titers||95% Confidence Interval|Geometric Mean
76642|NCT01035749|Primary|HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.||Fold increase||95% Confidence Interval|Geometric Mean
76643|NCT01035749|Primary|Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.||Subjects|||Number
76644|NCT01035749|Primary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.||Subjects|||Number
76645|NCT01035658|Primary|Phase I - Dose Limiting Toxicites|As requested, this outcome measure reports the number of patients experiencing dose limiting toxicites (DLTs) in the Phase I portion of the study|18 months|||participants|||Number
76646|NCT01035658|Secondary|To Evaluate the Toxicity of the Combination of Pazopanib and Liposomal Doxorubicin||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.|||||
76647|NCT01035658|Secondary|To Determine the Efficacy of Pazopanib/Liposomal Doxorubicin (Response Rate, Progression-free Survival, Overall Survival) Separately in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma||18 months||||||
76648|NCT01035658|Secondary|To Determine the Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin.||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.|||||
76649|NCT01035658|Primary|Phase II: Progression Free Survival|Defined as from date of randomization until objective tumor progression or death.|18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.|||||
76650|NCT01035658|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin|The MTD of the drug combination will be determined as the highest dose at which ≤1 of 6 subjects experiences a Grade 3 or Grade 4 DLT according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months|||mg|||Number
76651|NCT01035346|Secondary|Rating of Study Medication Relative to Usual Medication|Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||units on a scale||Standard Deviation|Mean
76652|NCT01035346|Secondary|Global Assessment of Study Medication as an Antipyretic|Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||units on a scale||Standard Deviation|Mean
76654|NCT01035346|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||hours||95% Confidence Interval|Median
76655|NCT01035346|Secondary|Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8|Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||Degrees Fahrenheit||Standard Deviation|Mean
76656|NCT01035346|Secondary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)|STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 4, 0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.||Degrees Fahrenheit||Standard Deviation|Mean
76657|NCT01035346|Primary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)|STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline temperature assessment.||Degrees Fahrenheit||Standard Deviation|Mean
76658|NCT01035333|Secondary|Patient Satisfaction||6 months|Patients who completed 6 months of the study.||participants|||Number
76659|NCT01035333|Primary|Weight Loss|Weight loss acheived during time on study up to 6 months.|6 months|All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months.||percentage of weight||Standard Deviation|Mean
76660|NCT01035255|Secondary|Percentage of Participants With New Onset of Atrial Fibrillation (AF)|Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).|up to 51 months|The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).||Percentage of participants|||Number
76661|NCT01035255|Secondary|Number of Patients With First Confirmed Renal Dysfunction|Number of patients with first confirmed renal dysfunction|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations||participants|||Number
76662|NCT01035255|Secondary|Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 8|FAS included all randomized patients with two exclusions: 6 pts who did not qualify for randomization but were misrandomized into the study and did not receive study meds; 37 pts because they were randomized at sites that were closed due to serious GCP violations The analysis included all FAS patients with at least one KCCQ data up-to Month 8.||KCCQ Score||Standard Error|Least Squares Mean
76663|NCT01035255|Secondary|Number of Patients Reported With Adjudicated Primary Causes of Death|Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014|up to 51 months|Randomized set (RAN): Consisted of all patients who received a randomization number, regardless of receiving trial medication.||participants|||Number
76664|NCT01035255|Secondary|Number of Patients - All-cause Mortality|Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations||participants|||Number
76665|NCT01035255|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations||participants|||Number
76674|NCT01035138|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) at Week 24|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numbers 1-3 are not added for total score. Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76666|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmax|Cmax is the maximum (peak) blood drug concentration after dose administration (ng/mL) calculated as the maximum of C1h and C2h. C1h was 1 hour post-dose blood concentration (ng/mL) and C2h was 2 hour post-dose blood concentration (ng/mL). C1h and C2h post-dose samples were collected from all patients in both arms at Visit 3. Steady-state for the C1h and C2h samples was defined as continuous administration of the same dose in the previous 4 days and the day on which the C1h and C2h samples were collected. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid C1h and C2h everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|Safety Set consists of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.||ng/mL||Standard Deviation|Mean
76667|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmin|Cmin is the pre-dose blood concentration at steady-state (ng/mL). Pre-dose (Cmin) blood samples were collected from all patients in both arms at Visit 3. Steady-state for the Cmin sample was defined as continuous administration of the same dose in the last 4 days prior to the collection of the Cmin sample. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid pre-dose (Cmin) everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|Safety Set consisted of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.||ng/mL||Standard Deviation|Mean
76668|NCT01035229|Secondary|Time to Definitive Deterioration of EORTC QLQ-C30 Scores|The primary quality of life endpoint was the time to definitive 5% deterioration from baseline in the global health status/quality of life scale of the EORTC QLQ-C30 questionnaire. Definitive deterioration by at least 5% is defined as a decrease in score by at least 5% compared to baseline, with no later observed increase above this threshold. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
76669|NCT01035229|Secondary|Time to Definitive Deterioration of ECOG Performance Score (PS) Score|Change in Eastern Cooperative Oncology Group (ECOG) were assessed by time to definitive performance status deterioration by at least one category on the ECOG scale. Deterioration was considered definitive if no improvement in the ECOG PS was observed at a subsequent measurement. ECOG PS: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5=Dead|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
76670|NCT01035229|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR is defined as the proportion of participants with a best objective response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST. The BOR was the best response recorded from the start of the treatment until disease progression. CR is disappearance of all target lesions; PR is at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is at least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.||Percentage of Participants|||Number
76671|NCT01035229|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of randomization to the date of the first documented radiologic confirmation of disease progression. Since the study did not meet the primary objective, TTP was not formally tested.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
76672|NCT01035229|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. The comparison of OS between the 2 arms was done using a stratified log-rank test at one-sided 2.5% level of significance.|When 454 OS events were observed|The Full Analysis Set (FAS) comprised all randomized patients.||Months||95% Confidence Interval|Median
76673|NCT01035138|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12|RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. Reported the change in number of hospitalizations per participant to week 12.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||number of hospitalizations||Standard Deviation|Mean
76675|NCT01035138|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24|The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the patient’s behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76676|NCT01035138|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24|The MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures. The total score ranges from 0 to 30, with a lower score indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76677|NCT01035138|Secondary|Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24|The CDR-SB is a semi-structured interview of participants and their caregivers. The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76678|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
76679|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
76680|NCT01035138|Secondary|Mean Concentration of LY450139||3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)|Participants who completed Study LFAN, took study drug in extension study and had pharmacokinetics measurements.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
76681|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76682|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76683|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76684|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Error|Least Squares Mean
76736|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Dehydroepiandrosterone (DHEA)|Change in DHEA was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
76685|NCT01035138|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio for the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator. Due to insufficient sample size, this analysis was not done.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Due to insufficient sample size, this analysis was not done.|||||
76686|NCT01035138|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12|The vMRI assessment of right hippocampal and left hippocampal volume is reported. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||cubic millimeter (mm³)||Standard Error|Least Squares Mean
76687|NCT01035138|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||percentage of change||Standard Error|Least Squares Mean
76688|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
76689|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.||units on a scale||Standard Deviation|Mean
76690|NCT01035060|Primary|Muscle Satellite Cells|Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.|Baseline, 2 days post-injury, 7 days post-injury|||Number of Pax7+ cells/muscle fiber||Standard Error|Mean
76691|NCT01035047|Secondary|Stress Testing-related Adverse Event||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis||participants|||Number
76692|NCT01035047|Secondary|Mortality||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis.||participants|||Number
76693|NCT01035047|Secondary|Acute Coronary Syndrome||Index Hospitalization discharge through 90 days|Data from all participants was used in outcome analysis.||participants|||Number
76694|NCT01035047|Secondary|Length of Stay||Duration of Index Hospitalization, an average of 1-2 days|Data from all participants was used in outcome analysis.||hours||Full Range|Median
76695|NCT01035047|Primary|The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.||Index Hospitalization through 90 days|Data from all participants was used in the primary outcome analysis.||participants|||Number
76696|NCT01034709|Primary|a) CMV Viral Load|The CMV viral load was measured by both the artus CMV RG PCR test and the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational sites and then the percent agreement between the two tests was determined.|3 months|||percentage of agreement|||Number
76697|NCT01034657|Secondary|Time to Cause-specific Death - Overall Period|Time to cause-specific death was defined as the time from start of treatment to death related to MDS.|52 weeks|Time to cause-specific death could not be evaluated because there was no cause-specific death.|||||
76698|NCT01034657|Secondary|Disease-free Survival (DFS) - Overall Period|DFS was defined as the time from start of treatment to the time to relapse.|52 weeks|DFS could not be evaluated because there was no disease-free period.|||||
76699|NCT01034657|Secondary|Progression-free Survival (PFS) - Overall Period|PFS was defined as the time from start of treatment to disease progression or death from MDS.|52 weeks|PFS could not be evaluated because there was no progression.|||||
76700|NCT01034657|Secondary|Event-free Survival (EFS) - Overall Period|EFS was defined as the time from start of treatment to failure or death from any cause.|52 weeks|Event-free survival could not be evaluated because there was no response, no progression or no disease-free period.|||||
76701|NCT01034657|Secondary|Time to Response - Overall Period|Time to response was defined as the time from start of treatment to the first documented response (complete [CR] or partial [PR]) according to modified IWG criteria for HI.|52 weeks|Time to response could not be evaluated because there was no response.|||||
76702|NCT01034657|Secondary|Overall Survival (OS) - Overall Period|OS was defined as the time from start of treatment to death from any cause.|48 weeks|All participants from the core phase were analyzed.||months||90% Confidence Interval|Median
76737|NCT01034397|Secondary|Change From Baseline to Week 24 in 17OHP|Change in 17OHP was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
76738|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
76739|NCT01034397|Secondary|Change From Baseline to Week 12 in 17 Hydroxy Progesterone (17OHP)|Change in 17OHP was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
76740|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
76703|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Participants from the randomized phase, who had values at week 52, were included in the analysis.||units on a scale||Standard Deviation|Mean
76704|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.||units on a scale||Standard Deviation|Mean
76705|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Only participants from the randomized phase, who had values at week 52, were included in the analysis.||Percentage of participants|||Number
76706|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.||Percentage of participants|||Number
76707|NCT01034657|Secondary|Percentage of Participants With Objective Response During the Randomized Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|32 weeks, 48 weeks|Participants from the randomized phase, who had valid data, were analyzed.||Percentage of participants|||Number
76708|NCT01034657|Secondary|Percentage of Participants With Objective Response During Core Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|16 weeks|Participants from the core phase, who had valid data, were analyzed.||Percentage of participants|||Number
76709|NCT01034657|Secondary|Percentage of Participants With HI-E - Randomized Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|32 weeks, 52 weeks|Participants from the randomized phase, who had valid response data, were analyzed.||Percentage of participants|||Number
76741|NCT01034397|Secondary|Change From Baseline to Week 24 in Plasma ACTH|Change in plasma ACTH was determined as the difference in the scores at baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
76710|NCT01034657|Primary|Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|16 weeks|Participants from the core phase, who had valid response data, were analyzed.||Percentage of participants|||Number
76711|NCT01034592|Secondary|Correction of Clinical Response With Ribosomal Protein Mutation Status and ex Vivo Effects of Lenalidomide on Marrow Erythroid Colony Growth and Microarray Gene Expression Signatures||Assessment done end of cycle 8 (Day 224)||||||
76712|NCT01034592|Secondary|Safety (Type, Frequency, Severity, and Relationship of Adverse Events to Lenalidomide)||Safety is monitored on a continuous basis throughout the trial period, and for 30 days after last dose of study medication||||||
76713|NCT01034592|Secondary|Duration of Response||Day 56 and end of cycle 8 (Day 224) or Early Discontinuation, then every month during Maintenance Phase||||||
76714|NCT01034592|Secondary|Bone Marrow Response||End of cycle 8 (Day 224) or Early Discontinuation, then every 6 months during Maintenance Phase||||||
76715|NCT01034592|Secondary|Platelet Response||Assessed weekly up to end of cycle 8 (Day 224) or Early Discontinuation, then every two weeks during Maintenance Phase with an additional assessment done 30 days (+/- 3 days) after last dose of study drug||||||
76716|NCT01034592|Secondary|Neutrophil Response||Assessed weekly up to end of cycle 8 (Day 224) or Early Discontinuation, then every two weeks during Maintenance Phase with an additional assessment done 30 days (+/- 3 days) after last dose of study drug||||||
76717|NCT01034592|Secondary|Change of Hemoglobin Concentration From Baseline||Assessed weekly up to end of cycle 8 (Day 224) or Early Discontinuation, then every two weeks during Maintenance Phase with an additional assessment done 30 days (+/- 3 days) after last dose of study drug||||||
76718|NCT01034592|Secondary|>50% Decrease in RBC Transfusion Requirements||Assessment done every 56 days: D56, D112, D168, D224, then every month during Maintenance Phase||||||
76719|NCT01034592|Primary|RBC Transfusion Independence|"The primary efficacy endpoint is red blood cell (RBC) transfusion independence (duration must be ≥ 2 months) based on MDS IWG 2000 criteria. RBC transfusion independence is defined as the continuous absence of the intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period, e.g. days 1 to 56, days 2 to 57, days 3 to 58, etc."|Assessment done every 56 days: D56, D112, D168, D224, then every month during Maintenance Phase|||percentage of patients|||Number
76720|NCT01034579|Secondary|Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker|Mean number of T2 active lesions was measured by using MRI scans. SNP5 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Mean number of T2 active lesions segregated on the basis of SNP5 marker variables were reported.|Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||T2 lesions||Standard Deviation|Mean
76721|NCT01034579|Secondary|Change in Brain Volume as Defined by SNP2 Marker|Change in brain volume was measured as the brain parenchymal fraction using MRI scans. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Change in brain volume segregated on the basis of SNP2 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||cubic millimeter (mm^3)||Standard Deviation|Mean
76722|NCT01034579|Secondary|Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers|Change in T1 Gd enhancing lesion volume was measured by using magnetic resonance imaging (MRI) scans. SNP4 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). SNP3 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Change in T1 Gd enhancing lesion volume segregated on the basis of SNP3 and SNP4 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||cubic millimeter (mm^3)||Standard Deviation|Mean
76723|NCT01034579|Secondary|Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Number of responders segregated on the basis of SNP2 marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||participants|||Number
76724|NCT01034579|Primary|Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers|A responder was defined as a participant with no multiple sclerosis (MS) relapse and no Expanded Disability Status Scale (EDSS) progression during 96 weeks in 24735 (NCT00078338). All responders were categorized on the basis of following six SNP markers: SNP1, SNP2, SNP3, SNP4, SNP5, and SNP6. Two types of variables were possible for each SNP marker: two-level genotype-based or three-level allele-based association variables. For the two-level genotype-based SNP markers (SNP2, SNP4, and SNP6), the absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). For the three-level allele-based association SNP markers (SNP1, SNP3, and SNP5), the analysis was based on the number of copies of the allele (0, 1 and 2). Percentage of responders segregated on the basis of SNP marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.||percentage of participants|||Number
76725|NCT01034553|Secondary|Overall Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.||Months||95% Confidence Interval|Median
76726|NCT01034553|Secondary|Progression-free Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.||Months||95% Confidence Interval|Median
76727|NCT01034553|Primary|Overall Response Rate to the Combination of MLN8237 and Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma.|sCR: Normal serum FLC ratio, and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, negative immunofixation of the serum and urine, <5% plasma cells in bone marrow, disappearance of any soft tissue plasmacytomas, and normalization of FLC ratio. VGPR:PR and serum and urine M-component detectable by immunofixation but not on electrophoresis, or if serum measurable,≥90% or greater reduction in serum M-component plus urine M-component <100 mg per 24h and if only measurable non-bone marrow parameter was FLC,≥90% or greater reduction in difference from involved and uninvolved FLC levels. PR:≥50% reduction of serum M-protein or reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24h or if FLC, ≥50% decrease in the difference between involved and uninvolved FLC levels or ≥50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥30%, and ≥50% reduction in the size of soft tissue plasmacytomas|Every 28 day cycle(up to 10 cycles)|All patients that received treatment were evaluated.||percentage of patients per dose level|||Number
76728|NCT01034553|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"Patients were evaluated over the first cycle of treatment for Dose Limiting Toxicities. For this trail DLTs are as follows:~An AE attributed (definitely, probably, or possibly) to study treatment during cycle 1 and the following criteria:~Grade 4 Neutropenia Grade 4 Thrombocytopenia, or grade 3 with bleeding Febrile neutropenia Creatinine serum great than 2 times baseline or upper limit of normal Grade 3 or higher Fatigue Grade 3 or higher nausea, vomiting, or diarrhea Any grade 3 or higher Non-hematologic toxicity per NCI CTCAE V4.0 Inability to initiate the scheduled cycle 2, day 1 due to toxicity~The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose."|28 days|||participants|||Number
76729|NCT01034540|Secondary|Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.|"Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose.~Disposition index = MISI x insulin secretion index"|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population excluding subjects with poor compliance and protocol violations.||Index value||Standard Error|Mean
76730|NCT01034540|Primary|Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).|Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population in which subjects with poor compliance, protocol violations, and without at least one post-randomization outcome data point during each treatment intervention period were removed.||Index value||Inter-Quartile Range|Median
76731|NCT01034462|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|"The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product.~The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score."||units on a scale||Standard Error|Least Squares Mean
76732|NCT01034462|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.||units on a scale||Standard Error|Least Squares Mean
76733|NCT01034397|Secondary|Change From Baseline to Week 24 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
76734|NCT01034397|Secondary|Change From Baseline to Week 12 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population||mg/dL||Full Range|Median
76735|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum DHEA|Change in DHEA was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population||mg/dL||Full Range|Median
76745|NCT01034397|Secondary|Change From Baseline to Week 24 in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Week 24|ITT population||mg/dL||Full Range|Median
76746|NCT01034397|Secondary|Change From Baseline to Week 12 in C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was measured in milligrams per deciliter (mg/dL).|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mg/dL||Full Range|Median
76747|NCT01034397|Secondary|Change From Baseline to Week 24 in ESR|ESR is an inflammatory marker and is used to assess disease activity in RA. A reduction in ESR indicates improvement.|Week 24|ITT population||mm/hr||Full Range|Median
76748|NCT01034397|Secondary|Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammatory marker and is used to assess disease activity in rheumatoid arthritis (RA). A reduction in ESR indicates improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mm/hr||Full Range|Median
76749|NCT01034397|Secondary|Health Assessment Questionnaire - Disease Index (HAQ-DI) Scores|The HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76750|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population||mm||Full Range|Median
76751|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mm||Full Range|Median
76752|NCT01034397|Secondary|Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specific parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||mm||Full Range|Median
76753|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Disease Activity|General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: “In general how would you rate your health over the last 2-3 weeks?”. Participants responded by marking the line and the distance from the left edge was recorded.|Week 24|ITT population||mm||Full Range|Median
76754|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Disease Activity|General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: “In general how would you rate your health over the last 2-3 weeks?”. Participants responded by marking the line and the distance from the left edge was recorded.|Week 12|ITT population||mm||Full Range|Median
76755|NCT01034397|Secondary|Change From Baseline to Week 24 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population||swollen joints||Full Range|Median
76756|NCT01034397|Secondary|Change From Baseline to Week 12 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population||swollen joints||Full Range|Median
76757|NCT01034397|Secondary|Change From Baseline to Week 24 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population||tender joints||Full Range|Median
76758|NCT01034397|Secondary|Change From Baseline to Week 12 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population||tender joints||Full Range|Median
76759|NCT01034397|Secondary|Tender and Swollen Joint Counts|TJC and SJC were determined using the 28 joint counts. Joints were classified as tender/not tender and swollen/not swollen and counted. The scores ranged from 0 to 28. Higher scores indicated higher disease activity.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||joints||Full Range|Median
76760|NCT01034397|Secondary|Change From Baseline to Week 24 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population||units on a scale||Full Range|Median
76761|NCT01034397|Secondary|Change From Baseline to Week 12 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76762|NCT01034397|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76763|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population||units on a scale||Full Range|Median
76764|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population||percent change||Full Range|Median
76765|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76766|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
76767|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;||units on a scale||Full Range|Median
76768|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;||percent change||Full Range|Median
76769|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76770|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
76771|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;||units on a scale||Full Range|Median
76772|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population||percent change||Full Range|Median
76773|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76774|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of initial rate of enhancement (IRE) and number of voxels (Nvox), which are extracted by examining individual signal intensity vs time curves derived from defined regions of interest (ROIs). A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. Maximum enhancement (ME)=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of signal intensity (SI) until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
76775|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.||percent change||Full Range|Median
84374|NCT00961805|Primary|Visual Analog Scale for Pain|score between 0 and 100 where 0 is no pain and 100 in unbearable pain|baseline, after 16 weeks and after 32 weeks|||mm||Standard Deviation|Mean
76776|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.||percent change||Full Range|Median
76777|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76778|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
76779|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.||units on a scale||Full Range|Median
76780|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population||percent change||Full Range|Median
76781|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76782|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
76783|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 24|ITT population.||units on a scale||Full Range|Median
76784|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76785|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.||units on a scale||Full Range|Median
76786|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.||percent change||Full Range|Median
76787|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||units on a scale||Full Range|Median
76788|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.||percent change||Full Range|Median
76789|NCT01034397|Primary|Percent Change From Baseline to Week 12 in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th metacarpophalangeal (MCP) were assessed for synovitis via magnetic resonance imaging (MRI) and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population; n (number) equals (=) number of participants assessed for the specified parameter||percent change||Full Range|Median
76790|NCT01034358|Primary|Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])|Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).|One year|||mMU/mL||95% Confidence Interval|Geometric Mean
76791|NCT01034306|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters||12 weeks||||||
76792|NCT01034306|Secondary|Safety: Adverse Event Reporting, Physical Examination, Vital Signs, Clinical Laboratory Testing||12 weeks||||||
76793|NCT01034306|Primary|American College of Rheumatology (ACR20)|Primary efficacy was assessed using ACR20 response at Week 12, with all-cause dropouts considered as non-responders, in the ITT population.|12 weeks|||participants|||Number
76794|NCT01034163|Primary|Number of Participants With Adverse Events|Safety monitoring was conducted throughout the study.|23 months|Safety set: The safety set included randomized participants who received at least one dose of study treatment.||Participants|||Number
76845|NCT01033864|Primary|Dose-Normalized Cmin|"Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
76795|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 104|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
76796|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 52|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 52|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
76797|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 24|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 24|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
76798|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 12|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 12|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
76799|NCT01034137|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Adverse Events Leading to Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), lifethreatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Up to Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment.||Number of participants|||Number
76800|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 104|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76801|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 52|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 52|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76846|NCT01033864|Primary|Minimum Plasma Concentration (Cmin)|The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
84375|NCT00961662|Secondary|Body Weight Loss (Compared to Baseline)||6 months||||||
76802|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 24|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 24|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76803|NCT01034137|Secondary|Mean Change From Baseline in The Revised Illness Perception Questionnaire (IPQ-R) Score of Quality of Life at Week 12|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 12|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76804|NCT01034137|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Score of Quality of Life at Weeks 12, 24, 52, and 104|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participants response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant’s health status.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76805|NCT01034137|Secondary|Mean Change From Baseline in Patient General Wellbeing Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their general wellbeing using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as  not active at all  and the right-hand extreme equals 10 as  very active  .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76806|NCT01034137|Secondary|Mean Change From Baseline in Patient Pain Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76807|NCT01034137|Secondary|Mean Change From Baseline in Physician Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Physician global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Physician global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76808|NCT01034137|Secondary|Mean Change From Baseline in Patient Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Patient global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Patient global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76847|NCT01033864|Primary|Dose-Normalized C0|"Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)"|Day 1 predose|PK population||mg/L||Standard Deviation|Mean
76809|NCT01034137|Secondary|Mean Change From Baseline in 36-Item Short Form Health Survey of Quality of Life at Weeks 12, 24, 52, and 104|The 36-Item Short Form Health Survey (SF-36) is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Summary (PCS) and Mental Component Summary (MCS) measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76810|NCT01034137|Secondary|Mean Change From Baseline in The EuroQol Score of Quality of Life at Weeks 12, 24, 52 and 104|"EuroQol (EQ-5D) is a standard self-completed participant questionnaire that measures health outcome. The EQ-5D questionnaire consists of 2 parts: 1) EQ-5D with five dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale as 1 = no problems, 2 = some/moderate problems, 3 = extreme problems. The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, where ‘1’ indicating full health and ‘0’ representing dead. The positive values indicate that during the study the health status improved. 2) EQ-VAS on a scale of 0 to 100, where 0 = worst possible health status and 100 = best possible health status.”"|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76811|NCT01034137|Secondary|Mean Change From Baseline in The Dutch Consensus Health Assessment Questionnaire of Quality of Life at Weeks 12, 24, 52, and 104|The Dutch Consensus Health Assessment Questionnaire (DC-HAQ) disability index is a self-completed participant questionnaire with 8 domains specific for RA. It assesses a participant functional ability, with scores ranging from 0 (without any difficulty) to 3 (unable to do). A change from baseline of –0.22 is considered to be the minimal clinically important difference.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Scores on a scale||Standard Deviation|Mean
76812|NCT01034137|Secondary|Number of Participants With Change in The Therapy Strategy During The Study|Participants who switched treatment strategy from monotherapy (TCZ+ placebo MTX or MTX+ placebo TCZ treatment) to combination therapy (TCZ+MTX treatment) was reported. Also, participants who switched from verum therapy to standard of care was reported in the below table.|From Baseline to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Number of participants|||Number
76813|NCT01034137|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (participants not responding to the drug as assessed by the physician) was selected by the investigator as a reason for the participant to withdraw from the study.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
76814|NCT01034137|Secondary|Mean Change From Baseline in Modified Sharp/Van Der Heijde Score at Weeks 52 and 104|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|From Baseline (Week 0) to Weeks 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Standard Deviation|Mean
76815|NCT01034137|Secondary|Mean Percent Change From Baseline in CRP at Weeks 12, 24, 52, and 104|CRP is a component of ACR. CRP is a marker of inflammation.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
76816|NCT01034137|Secondary|Mean Percent Change From Baseline in Pain Visual Analog Scale at Weeks 12, 24, 52, and 104|Pain VAS is a component of ACR. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
76817|NCT01034137|Secondary|Mean Percent Change From Baseline in The Physician Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Physician health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).An improvement (decrease) in the physician’s global assessment based on disease activity parameter relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
77496|NCT01027195|Secondary|Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay|Sum of daily morphine-equivalent mg narcotic usage during hospital stay.|daily during hospital stay (an expected average of 4 days)|||total morphine-equivalent mg||Standard Deviation|Mean
76818|NCT01034137|Secondary|Mean Percent Change From Baseline in Patient Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Patient health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity). An improvement (decrease) in the patient’s global assessment based on disease activity relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment||Percent change||Standard Deviation|Mean
76819|NCT01034137|Secondary|Mean Percent Change From Baseline in the Tender Joint Count (TJC) at Weeks 12, 24, 52, and 104|The number of tender joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender joints) to 44 (worse possible score; all tender joints).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
76820|NCT01034137|Secondary|Mean Percent Change From Baseline in the Swollen Joint Count (SJC) at Weeks 12, 24, 52, and 104|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
76821|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 90 Response Rate at Weeks 12, 24, 52 and 104|ACR90 response is defined as a >=90% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or erythrocyte sedimentation rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
76822|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 70 Response Rate at Weeks 12, 24, 52 and 104|ACR70 response is defined as a >=70% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient’s Assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
76823|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 50 Response Rate at Weeks 12, 24, 52 and 104|ACR50 response is defined as a >=50% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient’s assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s Global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
76824|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 20 Response Rate at Weeks 12, 24, 52 and 104|American College of Rheumatology (ACR) 20 response is defined as a >= 20% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: patient’s assessment of pain over the previous 24 hours: using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
76825|NCT01034137|Secondary|Median Time to First European League Against Rheumatism Response|It is the time to first EULAR response. EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant’s DAS28 as the measure of severity of disease.Good or moderate response is defined as follows: Good response : DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2. Response 1 is defined as yes (good) versus no (moderate or no response). Response 2 is defined as yes (good or moderate) versus no (no response).|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Days||Inter-Quartile Range|Median
76826|NCT01034137|Secondary|Number of Participants With Good European League Against Rheumatism Response Rate at Weeks 24, 52, and 104|European league against rheumatism (EULAR) response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant’s DAS28 as the measure of severity of disease. Good or moderate response is defined as follows: Good response : DAS28 at the time point =<3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and =<1.2.|Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
76827|NCT01034137|Secondary|Median Change From Baseline in Simplified Disease Activity Index Scores at Weeks 24, 52, and 104|The simplified disease activity index (SDAI ) are continuous measures of RA disease activity.The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm VAS), and C-Reactive Protein (CRP) (mg/dL). SDAI total score ranges from 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Full Range|Median
76828|NCT01034137|Secondary|Median Change From Baseline in Clinical Disease Activity Index Score at Weeks 24, 52, and 104|The clinical disease activity index (CDAI) are continuous measures of RA disease activity. The CDAI is the numerical sum of four outcome parameters: tender joint count (TJC), swollen joint count (SJC) based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS). CDAI total score ranges from 0 to 76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Full Range|Median
76829|NCT01034137|Secondary|Absolute Change From Baseline in Disease Activity Score 28 at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the participant’s disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Scores on a scale||Full Range|Median
76830|NCT01034137|Secondary|Mean Duration of First Disease Activity Score 28 Remission|It is the duration of the first period of DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Weeks||Standard Deviation|Mean
76831|NCT01034137|Secondary|Percentage of Participants With Cumulative Remission Rate at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the subject's disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
76832|NCT01034137|Secondary|Median Time to First Disease Activity Score 28 Remission|It is the time to event analysis for the first DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||Days||95% Confidence Interval|Median
76848|NCT01033864|Primary|Pre-dose Trough Concentration (C0)|The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment).|Day 1 predose|Pharmacokinetic (PK) population: all participants who took study drug and for whom all defined blood samples at the planned sampling time points were available.||mg/L||Standard Deviation|Mean
77031|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.|baseline, 4 months|Intention-to-treat||units on a scale||Standard Deviation|Mean
76833|NCT01034137|Secondary|Number of Participants Achieving Disease Activity Score 28 Remission at Weeks 12, 24, 52, and 104|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Number of participants|||Number
76834|NCT01034137|Secondary|Mean Duration of First Sustained Remission|It is the duration of the first period of sustained DAS28 remission. Participants who switch treatment strategy before reaching sustained remission considered failures.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.||Weeks||Standard Deviation|Mean
76835|NCT01034137|Secondary|Median Time to First Sustained Remission|It is the time to event analysis for the first period of sustained remission. Sustained remission is defined as DAS28 <2.6 during ≥23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts (range 0-28), acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.||days||95% Confidence Interval|Median
76836|NCT01034137|Primary|Percentage of Participants Achieving Sustained Remission Rate At Week 104|Sustained remission rate (SRR) is defined as Disease Activity Score 28 (DAS28) <2.6 during ≥ 23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 104|The intent to treat (ITT) population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsules and performed at least one post-baseline efficacy measurement.||Percentage of participants|||Number
76837|NCT01034111|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 4|Calculated as the mean change from baseline in fasting plasma glucose at Week 4.|Baseline and Week 4|||mmol/L||Standard Deviation|Mean
76838|NCT01034111|Primary|Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment|Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR’s product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.|4 weeks|||Participants|||Number
76839|NCT01033864|Secondary|Regression Coefficients For Participants Receiving MMF|The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L).|Day 1 at 30 minutes and 1 and 2 hours postdose|PK population. Only participants in the MMF/Prednisone group were assessed for this outcome measure, n=12.||mg/L|||Number
76840|NCT01033864|Primary|Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)||Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||percentage of participants|||Number
76841|NCT01033864|Primary|Dose-Normalized MPA AUC0-12|"Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg*h/L||Standard Deviation|Mean
76842|NCT01033864|Primary|MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)|The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg*h/L||Standard Deviation|Mean
76843|NCT01033864|Primary|Dose-Normalized Cmax (mg/L)|"Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
76844|NCT01033864|Primary|Maximum Plasma Concentration (Cmax)|The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population||mg/L||Standard Deviation|Mean
76849|NCT01033851|Secondary|Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.|This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).|2 months|The population analyzed included all participants attending at least one class of an intervention.||units on a scale||Standard Deviation|Mean
76850|NCT01033851|Primary|Active Symptoms of Generalized Anxiety Disorder|The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.|2 months|The population analyzed included all participants who attended at least one class of an intervention.||units on a scale||Standard Deviation|Mean
76851|NCT01033825|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population||percentage of devices|||Number
76852|NCT01033825|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population||Devices|||Number
76853|NCT01033825|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population||percentage of devices|||Number
76854|NCT01033825|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population||Devices|||Number
76855|NCT01033825|Secondary|Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.|Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).|Weeks 1-2, 2-4|Intent to Treat Population||percentage of correct advances||Standard Deviation|Mean
76856|NCT01033825|Secondary|Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||Number of days|||Number
76857|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76858|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76859|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76860|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76861|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
77497|NCT01027195|Secondary|Change in Hemoglobin Level|Change in hemoglobin level from baseline to the day of hospital discharge.|within 30 days before surgery (preop), day of hospital discharge|||g/dL||Standard Deviation|Mean
76862|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76863|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76864|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76865|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76866|NCT01033825|Primary|The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period|Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|week 6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Error|Least Squares Mean
76867|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76868|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76869|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76870|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76914|NCT01033565|Primary|Clinical Global Impression-Improvement|Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.|2 weeks|||units on a scale|||Number
76871|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76872|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76873|NCT01033825|Secondary|Baseline Daily Subject-reported PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76874|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76875|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76876|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76877|NCT01033825|Secondary|Baseline Daily Subject-reported AM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76878|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76915|NCT01033487|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally. Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in IC was the difference between IC and baseline IC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
77498|NCT01027195|Secondary|Estimated Blood Loss||Intraoperative (day of surgery)|||mL||Standard Deviation|Mean
76879|NCT01033825|Secondary|Baseline Daily Subject-reported PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76880|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Error|Least Squares Mean
76881|NCT01033825|Secondary|Baseline Daily Subject-reported AM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||units on a scale||Standard Deviation|Mean
76882|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Error|Least Squares Mean
76883|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Deviation|Mean
76884|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Error|Least Squares Mean
76885|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Deviation|Mean
76886|NCT01033825|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population||percentage of subjects|||Number
76887|NCT01033825|Secondary|Number of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population||participants|||Number
76888|NCT01033825|Secondary|Percentage of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population||percentage of subjects|||Number
76889|NCT01033825|Secondary|Number of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population.||participants|||Number
76890|NCT01033825|Secondary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population||percentage of subjects|||Number
76891|NCT01033825|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population.||participants|||Number
76892|NCT01033825|Secondary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.||percentage of subjects|||Number
76893|NCT01033825|Secondary|Number of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.||participants|||Number
76894|NCT01033825|Primary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline|AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.||mcg•h/dL||Standard Deviation|Mean
76895|NCT01033747|Secondary|Relative Change in Serum Ferritin From Baseline to 3.5 Years|The mean percentage change in serum ferritin was evaluated by comparing the serum ferritin level at the start of Deferasirox treatment to the serum ferritin level collected 18 months following the start of the extension study. Serum ferritin is measured in micrograms per Liter. Relative Change = 1- (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline to 3.5 years|All participants comprised of the full analysis set were evaluated for the change in serum ferritin.||Percent change||Full Range|Mean
76896|NCT01033747|Primary|The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox|The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100.|Baseline to 7 Years|All participants in the full analysis set treated with deferasirox for more than 3.5 years.||Percent change||Full Range|Mean
76897|NCT01033734|Secondary|Participants With Greater Than or Equal to (>=) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Day 1, 6 and 30|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.||Participants|||Number
76898|NCT01033734|Secondary|Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not collected because of changes in planned analysis, due to early study termination.|||||
76899|NCT01033734|Secondary|Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.|||||
76900|NCT01033734|Secondary|Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.|||||
76901|NCT01033734|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
76902|NCT01033734|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
76903|NCT01033734|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.||hours||Geometric Coefficient of Variation|Geometric Mean
76904|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
76905|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
76906|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
76907|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
76908|NCT01033734|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
76909|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
76910|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
76911|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
76912|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
76913|NCT01033734|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
76931|NCT01033227|Secondary|Secondary End Point|a) reduced the duration and intensity of pain; b) reduced total narcotic analgesic consumption; and c) reduced length of hospitalization.|48 hours||||||
76916|NCT01033487|Secondary|Change From Baseline in Force Vital Capacity (FVC)|FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in FVC was the difference between FVC and baseline FVC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
76917|NCT01033487|Secondary|Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5. Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 24.5 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
76918|NCT01033487|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Peak FEV1 was defined as change from baseline in maximum FEV1. Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose. Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
76919|NCT01033487|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.|||||
76920|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.|||||
76921|NCT01033487|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.|||||
76922|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||(pg*hr/mL)/mcg||Standard Deviation|Geometric Mean
76923|NCT01033487|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||pg*hr/mL||Standard Deviation|Geometric Mean
76924|NCT01033487|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||hr||Full Range|Median
76925|NCT01033487|Primary|Dose Normalized Maximum Observed Plasma Concentration|Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||(pg/mL)/mcg||Standard Deviation|Geometric Mean
76926|NCT01033487|Primary|Maximum Observed Plasma Concentration (Cmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||Picogram/milliliter (pg/mL)||Standard Deviation|Geometric Mean
76927|NCT01033487|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.|Baseline, 24, 24.5 hrs post-dose|Full Analysis Set (FAS) population included all randomized participants and who had received at least one dose of randomized treatment.||Liter||Standard Deviation|Mean
76928|NCT01033383|Secondary|Not Growth|The number of not growth, these include no growth, growth <100,000 CFU/ml, growth >100,000 CFU/ml but no WBCs, and mixed flora.|one month|The analysis population were those with completed labs data.||urine cultures and urinalyses|Participants||Number
76929|NCT01033383|Secondary|Other Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with other bacteriuria plus any white blood cells (WBCs) >100,000 colony that include: Proteus, Klebsiella, Enterococcus, beta-hemolytic Streptococci, viridans Streptococci, and organella morganii, Citrobacter freundii, and coagulase-negative Staphylococcus.|one month|The analysis population were those with completed labs data.||urine cultures and urinalyses|Participants||Number
76930|NCT01033383|Primary|E.Coli Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.|One month|The analysis population were those with completed labs data.||urine cultures and urinalyses|Participants||Number
76932|NCT01033227|Primary|48 Hour Sodium Nitrite Infusion is Safe as Determined by no Adverse Events|The primary end points will be to determine if a) a 48-hour sodium nitrite infusion is tolerated without a decrease in mean arterial blood pressure by 15mmHg for greater than 2 hours or development of methemoglobin greater than 5% and b) a 48-hour sodium nitrite infusion is safe as determined by monitoring for adverse events|48 hours from start of infusion|||Participants|||Count of Participants
76933|NCT01033071|Secondary|Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the non-missing values of the 3 serial trough sitting blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||percent of participants|||Number
76934|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||percentage of participants|||Number
76935|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the non-missing values of the 3serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||percentage of participants|||Number
76936|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76937|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76938|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76939|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76940|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76941|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
77013|NCT01032382|Secondary|Pharmacokinetic Parameter: Tmax|Pharmacokinetic Parameter: Tmax|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). On day 1, Paromomycin Alone Treatment group N = 4; WR 279,396 group N = 3.||hr||Standard Deviation|Mean
76942|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76943|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76944|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76945|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76946|NCT01033071|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76947|NCT01033071|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76948|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.|The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76949|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76950|NCT01033071|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
76951|NCT01033032|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)||participants|||Number
76952|NCT01033032|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 6 weeks until treatment discontinuation, expected average of 18 months|Includes patients treated at the MTD (Dose Level 3)||months||95% Confidence Interval|Median
76953|NCT01033032|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)||participants|||Number
77014|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)||ng/mL||Standard Deviation|Mean
76954|NCT01033032|Primary|Progression-free Survival (PFS)|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 6 weeks until progressive disease|Includes patients treated at the MTD (Dose Level 3)||months||95% Confidence Interval|Median
76955|NCT01033019|Primary|Clinical Evaluation of sBCCs Tumors|The clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|Day 43|Efficacy analysis set: the efficacy analysis set included all randomized participants with evaluable data.||Participants|||Number
76956|NCT01032993|Secondary|Percentage of Participants With Adverse Effects|serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.|4 weeks|3 serious adverse events occurred during the study that were judged unrelated to the study: specifically, 3 participants were hospitalized prior to randomization, 1 for pneumonia; 1 for a back injury; and 1 for a mental health condition. All recovered. There were no SAE during the randomization period. Non serious AEs are listed below.||% of participants reporting|||Number
76957|NCT01032993|Secondary|Percentage of Participants With Improvement in Disability Related to Muscle Pain|Disability improvement was based on patient report of improvement they felt was meaningful to them|4 weeks|||% reporting improved function|||Number
76958|NCT01032993|Secondary|Continuation of Statin|Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.|4 weeks|||participants|||Number
76959|NCT01032993|Primary|Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use|Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10|4 weeks|||% of participants with pain reduction|||Number
76960|NCT01032928|Primary|Optimal Respiratory - Swallow Phase|Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks|||percentage of swallows|||Number
76961|NCT01032928|Secondary|Percentage of Impairment According to the Penetration-Aspiration Scale|The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Scores < 3 are considered to be normal. For the purpose of our study scores were dichotimized to normal and impaired.|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks|||percentage of swallows with impaired PAS|||Number
76962|NCT01032928|Secondary|Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)|Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks|||percentage of impairment|||Number
76963|NCT01032915|Secondary|Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Score||Standard Deviation|Mean
76964|NCT01032915|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score.|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Letters||Standard Deviation|Mean
76965|NCT01032915|Secondary|Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks|Participants could have received up to 5 immunosuppresive agents (prednisone, cyclosporine, azathioprine, methotrexate, mycophenolate). Immunosuppressive Medication Score (IMS) is a combined, single numeric score derived on basis of total daily dose of specific immunosuppressive agents / unit body weight, ranged on a scale from 0-9 for the total daily dose in mg per kg. Patients receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS (or its reduction from baseline) showed better clinical outcome|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Score||Standard Deviation|Mean
76966|NCT01032915|Primary|Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baselineRecurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.||Days||95% Confidence Interval|Median
76967|NCT01032889|Secondary|Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.||mm||95% Confidence Interval|Least Squares Mean
76968|NCT01032889|Secondary|Change From Baseline in Submental Fat Volume|Submental fat volume was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.||mm³||95% Confidence Interval|Least Squares Mean
76969|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
76970|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
76971|NCT01032889|Primary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified Intent-to-Treat (mITT) population including all randomized participants who received at least 1 injection of study drug and had at least 1 post-baseline observation for CR-SMFRS, Subject Self-Rating Scale (SSRS), or magnetic resonance imaging (MRI) volume. Last observation carried forward (LOCF) method was used to impute missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
76972|NCT01032850|Secondary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years|||months||95% Confidence Interval|Median
76973|NCT01032850|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|5 years|||Months||95% Confidence Interval|Median
76974|NCT01032850|Secondary|Disease Control Rate of Response (DCR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease control rate (DCR) is the sum of the percentages of patients achieving complete and partial responses and stable disease|6 months|||percentage of participants|||Number
76975|NCT01032850|Primary|Number of Participants Experiencing Adverse Events|The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.|6 months|||participants|||Number
76976|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics|The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.|Day 1 through Day 40|ITTI population||participants|||Number
76977|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses During the Study|The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.|Day 1 through Day 40|ITTI population||participants|||Number
77015|NCT01032382|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|0 and 4 hours on days 1 and 20|Children ages 5 to 17 (inclusive)||ng/mL||Standard Deviation|Mean
76978|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Adults|Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including adults only (>12 years old).||hours||95% Confidence Interval|Median
76979|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Children|Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including children only (ages 1 - 12 years).||hours||95% Confidence Interval|Median
76980|NCT01032837|Secondary|Time to Resolution of Fever|Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or ≥ 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is ≤ 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.|Day 1 through Day 40|ITTI population with fever at Baseline.||hours||95% Confidence Interval|Median
76981|NCT01032837|Secondary|Number of Participants With Development of Oseltamivir-Resistant Influenza Virus|The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.|40 days|ITTI Population||participants|||Number
76982|NCT01032837|Secondary|Change From Baseline in Influenza Titer Measured by Viral Culture|Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).|Baseline, Days 2 through 15|ITTI||Log10 TCID50||Standard Deviation|Mean
76983|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction|Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI||percentage of participants|||Number
76984|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture|Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI||percentage of participants|||Number
76985|NCT01032837|Primary|Time to Cessation of Viral Shedding|The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.|Day 1 to Day 40|ITT infected (ITTI) Population, including all patients randomized who received at least one dose of study medication with laboratory confirmation of pandemic (H1N1) 2009 influenza infection, excluding patients infected with oseltamivir-resistant influenza A H1N1 H275Y at baseline and patients not shedding virus at baseline.||hours||95% Confidence Interval|Median
76986|NCT01032759|Secondary|Chronic Post-surgical Pain||1 month, 3 month, 6 month|Data was not collected and therefore not analyzed.|||||
76987|NCT01032759|Secondary|Patient Satisfaction|"Number of participants who reported very satisfied or somewhat satisfied"|48 hours|Number of participants who had this outcome reported and documented.||participants|||Number
76988|NCT01032759|Secondary|Hyperalgesia|Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a “painful,” “sore,” or “sharper” feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision.|Within 48 h|Number of participants who had this outcome measured and documented||cm2||Standard Deviation|Mean
76989|NCT01032759|Secondary|Opioid Related Side Effects: Pruritus|Number of participants who experienced pruritus.|0-24 h|||participants|||Number
76990|NCT01032759|Secondary|Opioid Related Side Effects|Number of participants with postoperative nausea and vomiting.|0-24 h|||participants|||Number
76991|NCT01032759|Primary|24 hr Opioid Consumption||24 hr|Participants who completed the 24 hour assessment.||mg morphine equivalents||Standard Deviation|Mean
76992|NCT01032759|Secondary|Pain Scores|Pain score (0=no pain, 10= worst possible pain)|48 hours|Participants who completed the 48 hour assessment.||units on a scale||Standard Deviation|Mean
76993|NCT01032733|Secondary|Mitochondrial Function (Cox IV Subunit)|Western blot analysis was performed to determine complex content. The amount of Cox IV subunit was determined for each Reporting Group via Western Blot analysis at baseline and week 24.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. In addition, the discrepancy for the number of participants is becasue we could only obtain information on a subset of participants due to the nature of the procedure (muscule biopsy).||fold change (ug/ml)||Standard Deviation|Mean
76994|NCT01032733|Secondary|Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms).|Maximal knee extension strength using each participant’s strongest leg was measured using a Biodex. The participants were asked to develop their maximal isokinetic knee extension strength. Three trials of 5 repetitions were performed and the peak torque value was used for statistical analyses.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.||kilograms||Standard Deviation|Mean
76995|NCT01032733|Secondary|Short Physical Performance Battery|Scores on the Short Physical Performance Battery (SPPB) were obtained at baseline and at the 24-week post-treatment assessment visit. The SPPB consists of a 4 meter walk, repeated chair stands, and three hierarchical standing balance tests. The time to complete each of the three performance measures was assigned a categorical score based on normative data, ranging from 0 to 4. A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by adding walking speed, chair stands, and balance scores.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.||score on the SPPB||Standard Deviation|Mean
76996|NCT01032733|Secondary|Body Weight|Body weight was measured under fasting conditions following voiding in the morning at baseline and at the 24-week post-treatment assessment.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so 'centered' with a baseline carried forward mechanism).||kilograms||Standard Deviation|Mean
76997|NCT01032733|Primary|Performance on the 400 Meter Walk|Walking speed was assessed at baseline and 24-week assessment by the 400 Meter Walk Test, during which participants were asked to complete a standard walking course at their usual pace. Participants were permitted to stop during the walk but were not allowed to sit or receive help from others and were required to complete the course in 15 minutes.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so ‘centered’ with a baseline carried forward mechanism).||meters per second||Standard Deviation|Mean
76998|NCT01032694|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percentage of Participants|||Number
76999|NCT01032694|Secondary|Percent Compliance With the Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percent compliance||Standard Deviation|Mean
77000|NCT01032694|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant’s convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered ‘very convenient’ or ‘somewhat convenient’ and 0 if participant answered ‘not convenient’ or ‘not at all convenient’.|Days 11-12|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. Missing observations were not imputed. 'N' signifies the number of participants with non-missing data.||Percentage of Participants|||Number
77001|NCT01032538|Secondary|Oxford Knee Score||10 years postoperatively||||||
77002|NCT01032538|Secondary|Knee Injury and Osteoarthritis Outcome Score||10 years postoperatively||||||
77003|NCT01032538|Secondary|UCLA Score||Preoperative until 2 years postoperatively||||||
77004|NCT01032538|Secondary|Oxford Knee Score||Preoperative until 2 years postoperatively||||||
77005|NCT01032538|Secondary|Range of Motion||Preoperative until 2 years postoperatively|||degrees||95% Confidence Interval|Mean
77006|NCT01032538|Primary|Knee Injury and Osteoarthritis Outcome Score|Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.|Preoperative until 2 years postoperatively|||units on a scale||95% Confidence Interval|Mean
77007|NCT01032382|Secondary|Number of Index Lesions Meeting Criteria for Clinical Cure During the Study|Number of study participants who meet the criteria for clinical cure (100% re-epithelialization) at specified timepoints during the study.|Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168|||Lesions meeting clinical cure criteria|||Number
77008|NCT01032382|Secondary|Final Clinical Cure on All Lesions Independent of Subjects|"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND,~Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168|||Cured ulcerated lesions|Participants||Number
77009|NCT01032382|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults (18+ years)||hr/ML||Standard Deviation|Mean
77010|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)||1/ML||Standard Deviation|Mean
77011|NCT01032382|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). WR 279,396 group measurements Day 1 N = 2 and Day 20 N = 4. One study participant in the Paromomycin Alone Treatment was withdrawn at Day 100.||hr||Standard Deviation|Mean
77012|NCT01032382|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)||ng*hr/mL||Standard Deviation|Mean
77499|NCT01027195|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)|||participants|||Number
77017|NCT01032382|Primary|Final Clinical Cure for Index Lesions|"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,~Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168|||participants|||Number
77018|NCT01032291|Primary|Percentage of Participants With a Response to Treatment During the Proof of Concept Period|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).~Treatment response includes both complete response and partial response.~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Analysis was not performed due to the early termination of the study."|week 9 up to week 24|Efficacy Evaluable Population. Analysis was not performed due to the early termination of the study.|||||
77019|NCT01032291|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|TEAEs are any adverse event occurring or worsening on or after the first treatment of any study drug and within 28 days after the last dose of the last study drug received. Relation to study drug was determined by the investigator. Severity of AE is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0. Severity is a 5-point scale: 3= severe or medically significant but not life-threatening 4=life-threatening, urgent intervention required 5=death related to AE.|up to week 28|Participants who took at least one dose of study treatment.||participants|||Number
77020|NCT01032291|Secondary|Kaplan-Meier Estimates for Overall Survival|"Overall survival was defined as the time between randomization and death. It was intended that participants would be followed for up to 5 years following discontinuation from treatment.~Analysis was not performed due to the early termination of the study."|up to 5.5 years|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
77021|NCT01032291|Secondary|Percentage of Participants With Disease Control|"Known as the Disease Control Rate (DCR), participants with a complete response, partial response or stable disease contribute to the DCR.~This analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
77022|NCT01032291|Secondary|Kaplan-Meier Estimates for Duration of Response|"Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR).~Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
77023|NCT01032291|Secondary|Kaplan-Meier Estimates for Progression Free Survival (PFS)|"PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD), or death on study due to any cause.~Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.|||||
77024|NCT01032291|Post-Hoc|Best Overall Response Assessed by an Independent Review Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) During the Proof of Concept Period Prior to Early Study Termination|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions.~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.~Participants with evidence of objective tumor response have the response confirmed with repeat assessments performed at the next scheduled scan."|Week 9 up to week 24|Intent to treat population.||participants|||Number
77025|NCT01032291|Primary|Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period|"The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period:~If <2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg.~If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide.~If <2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg.~If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide.~If <2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg.~If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators."|Up to Day 28 (Cycle 1)|All participants who took at least one dose of study medication. If a participant discontinued the study prior to completing the entire first cycle for reasons other than a DLT or if ≥7 days of lenalidomide and/or ≥1 dose of cetuximab were missed during the first cycle for reasons other than a DLT, a replacement would be added at that dose level.||participants|||Number
77026|NCT01032265|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)||4 months|Intention-to-treat||participants|||Number
77027|NCT01032265|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, 4 months|Intention-to-treat||episodes per week||Standard Deviation|Mean
77028|NCT01032265|Secondary|Patient Satisfaction||4 months|Intention-to-treat||participants|||Number
77029|NCT01032265|Secondary|Usage of Incontinence Aids|Only those using incontinence aids at baseline were included in the analysis.|baseline, 4 months|Intention-to-treat||participants|||Number
77030|NCT01032265|Secondary|EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)|health-specific quality of life, range 0-100, higher scores indicate better quality of life.|baseline, 4 months|Intention-to-treat||units on a scale||Standard Deviation|Mean
77032|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|summed symptom-score, range 0–21, with higher scores indicating greater severity.|baseline, 4 months|Intention-to-treat||units on a scale||Standard Deviation|Mean
77033|NCT01032200|Secondary|HVLT-IR|HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.|4 weeks post-RT|Participants with any data||number of correctly recalled words||Standard Error|Least Squares Mean
77034|NCT01032200|Secondary|Sleepiness|Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.|4 weeks post-RT|Participants with any data||units on a scale||Standard Error|Least Squares Mean
77035|NCT01032200|Secondary|Fatigue|Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. Higher scores indicate less fatigue.|4 weeks post-RT|Participants with any data||units on a scale||Standard Error|Least Squares Mean
77036|NCT01032200|Primary|Adherence|Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)|4 weeks post-RT (approximately 3 months post randomization)|Participants who returned pill diaries||percentage of ideal number of pills||Full Range|Mean
77037|NCT01032200|Primary|Retention|Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.|4 weeks post-RT (approximately 3 months post randomization)|All randomized participants||percentage of participants|||Number
77038|NCT01032174|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percentage of Participants|||Number
77039|NCT01032174|Secondary|Percent Compliance With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.||Percent compliance||Standard Deviation|Mean
77040|NCT01032174|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant’s convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered ‘very convenient’ or ‘somewhat convenient’ and 0 if participant answered ‘not convenient’ or ‘not at all convenient’.|Day 11|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. 'N' signifies number of participants with non-missing data. Missing observations were not imputed.||Percentage of Participants|||Number
77041|NCT01032070|Secondary|Apparent Volume of Distribution (Vz/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||mL/m^2||95% Confidence Interval|Geometric Mean
77042|NCT01032070|Secondary|Apparent Body Clearance (CL/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||mL/h/m^2||95% Confidence Interval|Geometric Mean
77043|NCT01032070|Secondary|Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||hours||95% Confidence Interval|Geometric Mean
77044|NCT01032070|Secondary|Maximum Observed Plasma Concentration of Erlotinib (Cmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set||ng/mL||95% Confidence Interval|Geometric Mean
77045|NCT01032070|Secondary|Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set (PKAS) consisted of the participants treated with erlotinib for whom sufficient analyte concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter. Participants may have been excluded from the PKAS for reasons such as missing data or protocol deviation.||h*ng/mL||95% Confidence Interval|Geometric Mean
77065|NCT01031953|Primary|Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure."|Baseline to 2 hours after study drug administered.|||participants|||Number
77500|NCT01027195|Secondary|Number of Units Transfused||daily during hospital stay (an expected average of 4 days)|||units of blood||Standard Deviation|Mean
77046|NCT01032070|Secondary|Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs.~An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. The relationship of each AE to study drug was assessed as either related or not related."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|All enrolled participants who received at least 1 dose of study drug (Safety Analysis Set).||participants|||Number
77047|NCT01032070|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.|From randomization up to 12 months after the last dose. Median duration of follow-up was 12.9 months for erlotinib and 14.4 months for etoposide.|The Full Analysis Set||days||95% Confidence Interval|Median
77048|NCT01032070|Secondary|Duration of Stable Disease|"Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD.~Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR, PR, MR or SD.||days||95% Confidence Interval|Median
77049|NCT01032070|Secondary|Percentage of Participants With Prolonged Stable Disease|Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||percentage of participants||95% Confidence Interval|Number
77050|NCT01032070|Secondary|Progression Free Survival (PFS)|"Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first.~Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||days||95% Confidence Interval|Median
77051|NCT01032070|Secondary|Percentage of Participants With Disease Control|"Disease control is a best overall response of CR or PR or MR or Stable disease (SD).~CR:~Complete disappearance of all enhancing tumor and mass effect~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks~If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively).~PR:~≥ 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks.~MR:~≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks.~SD:~Neurologic examination is at least stable~Maintenance corticosteroid dose is not increased~MRI meets neither the criteria for minor response nor for progressive disease~Sustained for ≥ 8 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||percentage of participants||95% Confidence Interval|Number
77052|NCT01032070|Secondary|Percentage of Participants With a Minor Response|"Participants with a best overall response of minor response (MR), defined as:~≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set||percentage of participants||95% Confidence Interval|Number
77053|NCT01032070|Secondary|Duration of Response|"Duration of response (complete or partial response [CR/PR]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR.~Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR or PR.||days||95% Confidence Interval|Median
84376|NCT00961662|Secondary|A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study||6 months||||||
77054|NCT01032070|Primary|Percentage of Participants With an Objective Response|"Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks.~CR:~Complete disappearance of all enhancing tumor and mass effect~On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses)~Stable or improving neurologic examination sustained for ≥ 4 weeks~If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings).~PR:~≥ 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set (FAS) consisted of all randomized participants. Following the intent-to-treat (ITT) principle, participants were analyzed according to the treatment arm they were assigned to at randomization.||percentage of participants||95% Confidence Interval|Number
77055|NCT01032044|Primary|"Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated"|"Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of Optimally Treated, in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up."|3 month follow-up endoscopic procedure|Among the 141 patients who completed the initial procedure, 119 had follow-up visits.||participants|||Number
77056|NCT01032018|Primary|Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)||6 months after randomization|||dollars||Standard Error|Mean
77057|NCT01032018|Primary|Depressive Symptom Reduction|Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.|Change from depression at baseline to depression at 6-months|||Scores on a scale||Standard Deviation|Mean
77058|NCT01031953|Secondary|Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness|Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.|up to 24 hours after study drug administered.|||participants|||Number
77059|NCT01031953|Secondary|Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant|Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).|up to 24 hours after study drug administered.|||participants|||Number
77060|NCT01031953|Secondary|Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)|The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome|up to 24 hours after receiving fosaprepitant|||participants|||Number
77061|NCT01031953|Secondary|Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)|Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief|2 hours after administration of Fosaprepitant 150 mg IV|||participants|||Number
77062|NCT01031953|Secondary|Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours|Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.|Baseline to 24 hours after study drug administered.|||participants|||Number
77063|NCT01031953|Secondary|Improvement in Nausea Score From 2 Hours to 24 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure."|2 hours to 24 hours after study drug administered.|||participants|||Number
77064|NCT01031953|Secondary|Improvement in Nausea Score From Baseline to 12 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure."|Baseline to 12 hours after study drug administered.|||participants|||Number
77077|NCT01031680|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
84377|NCT00961662|Secondary|A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study||8 months||||||
77066|NCT01031914|Primary|Sleep/Wake Algorithm|We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true positives + number of true negatives/ number of true positives + false positives + false negatives +true negatives. where True positive = the algorithm tested correctly identified sleep, False positive = the algorithm tested incorrectly identified sleep, True negative = the algorithm tested correctly rejected awake periods, and False negative = the algorithm tested incorrectly rejected awake periods.|The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours.|All the participants completing the sleep study were included in the analysis||accuracy (%)|||Number
77067|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at week12|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.~Scale range (0-52):~A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 12|||Score on a scale||Standard Deviation|Mean
77068|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 16|||units on a scale||Standard Deviation|Mean
77069|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 12|||units on a scale||Standard Deviation|Mean
77070|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 04|||units on a scale||Standard Deviation|Mean
77071|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Weeks 00|||units on a scale||Standard Deviation|Mean
77072|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at Baseline|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.~Scale range (0-52):~A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 00 (baseline)|||units on a scale||Standard Deviation|Mean
77073|NCT01031706|Secondary|FEV1 (Spirometry) Change|Absolute change in % predicted FEV1 between baseline and after 4 weeks of treatment calculated|Baseline and after 4 weeks of treatment|All available data included. Carry-forward of last FEV1 value (after 2 weeks of treatment) performed when data at 4 week time point not available||Percentage of predicted FEV1||Standard Error|Mean
77074|NCT01031706|Primary|Change in Mucociliary Clearance Rate|"Average radio tracer clearance through 90 minutes (MCC90) is primary index of mucociliary clearance at each study.~Primary study outcome: is absolute change in MCC90 between baseline and at end of treatment (where MCC measured 8-12 hours after final dose of study drug) - reflects sustained impact on MCC"|Baseline versus after completion of 4 week treatment period|All subjects with available data analyzed||percent clearance||Standard Error|Mean
77075|NCT01031680|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full analysis set; participants with baseline BMI ≥27 kg/m² and Week 24 (LOCF) body weight value||Percentage of participants||95% Confidence Interval|Least Squares Mean
77076|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
84378|NCT00961662|Secondary|A Decrease of ≥0.5% in HbA1c Level at Each Study Visit||6 months||||||
77078|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, participants with non-missing baseline and Week 8 (LOCF) values||mmHg||95% Confidence Interval|Least Squares Mean
77079|NCT01031680|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Number
77080|NCT01031680|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
77081|NCT01031628|Primary|Evaluation of Lesions for Progression or Response Via RECIST Criteria||Every 3 months|Data were not collected or analyzed due to early termination.|||||
77082|NCT01031550|Secondary|Decrease in Liver Lipid Peroxidation and Apoptosis||first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
77083|NCT01031550|Secondary|Length of ICU and Hospital Stay||first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
77084|NCT01031550|Secondary|Peak Postoperative AST, ALT and T Bili||first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
77085|NCT01031550|Primary|Post Operative Complications Grade IIIb or Greater According to Clavien's Classification Which is a Classification System Used to Grade Surgical Complications|Post operative complications grade IIIB or greater according to Clavien's classification: IIIb=complication necessitating an intervention under general anesthesia; Grade IV=Life threatening complications requiring ICU management, IV a =single organ dysfunction, IVb=multi-organ dysfunction; V=death Suffix d(disability)=subject suffers from complication at time of discharge. This label indicates the need for a follow up to fully evaluate the complication.|first 7 post operative days|Due to termination of the study no data analysis was performed.|||||
77086|NCT01031498|Primary|Number of Patients With Complete Response|Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as < or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.|7 days, starting first day of chemotherapy|Analysis was per protocol. Seven patients were excluded from the efficacy analysis.||participants|||Number
77087|NCT01031446|Secondary|Time to Progression in Patients With Metastatic Basal-like Breast Cancer.|Median duration in months from on-study to disease progression in patients with metastatic basal-like breast cancer. All patients with basal-like breast cancer are negative for estrogen, progesterone, and human epidermal growth factor (HER2) receptors.|Up to 64 weeks|Patients who are negative for estrogen, progesterone and HER2 receptors. Time to progression was not determined for 5 patients in this group: toxicity (2), withdrew after beginning treatment (1), no progression (1), and on-treatment (1).||months||Full Range|Median
77088|NCT01031446|Primary|Patients With Progression-free Survival|Patients who had not experienced disease progression and who were alive at 6 months after study entry|at 6 months|Patient who received the study drugs. Four patients were not available for measurement of progression at 6 months: toxicity (3), withdrew after beginning treatment (1)||participants|||Number
77089|NCT01031446|Secondary|Time to Progression|Duration in months from date on-study to date patient exhibited progressive disease|Up to 64 weeks|Patients who were available for determination of duration of time to progressive disease. Time to progression is unknown for 8 Phase II patients due to: on-treatment (1), toxicity (3), withdrew after beginning treatment (1), and no progression (3)||months||Full Range|Median
77090|NCT01031446|Secondary|Patients With Overall Response|Per Response Evaluation Criteria in Solid Tumor (RECIST) criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 12 weeks|Patients for whom an overall response could be measured. Four patients were not evaluable due to: withdrew after beginning treatment (1) and not evaluable due to only 1 cycle of treatment (3).||participants|||Number
77091|NCT01031446|Primary|Maximum Feasible Dose in mg of RAD001 (Everolimus)for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per day in Phase I that allows for safe and feasible administration the medication. The MTD is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy|at 8 weeks|Patients enrolled to determine the safety profile and recommended dose of cisplatin + RAD001 + paclitaxel in women with metastatic breast cancer||mg|||Number
77110|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
78011|NCT01020123|Secondary|Leukocytes; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 198 in CSR)||*10^3 cells/µL||Standard Deviation|Mean
77092|NCT01031446|Primary|Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.|at 8 weeks|Patients enrolled to determine the safety profile and recommended doses of cisplatin + paclitaxel + everolimus (RAD001) in women with metastatic breast cancer||mg/m2|||Number
77093|NCT01031381|Secondary|Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)|The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Within 4 weeks (28 days) of study treatment initiation (baseline)|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days + imaging every 8-12 weeks||participants|||Number
77094|NCT01031381|Primary|Progression-free Survival (PFS) at 6-months|The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Up to 36 months (data collection period for the cohort); Up to 6 months for participant|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days||percentage of participants||95% Confidence Interval|Number
77095|NCT01031095|Primary|Major Adverse Cardiac Event||30 days|||percentage of event|||Number
77096|NCT01031095|Primary|Major Adverse Cardiac Events||30 days|||percentage of event|||Number
77097|NCT01031043|Primary|Distal Contractile Integral|The index of contractile strength of the esophageal smooth muscle. The range of the index being 0 mmHg *s*cm to >10,000 mmHg *s*cm where 0 represents no contractile strength. The index reflects the magnitude of distal esophageal contraction, taking into consideration the length, strength, and duration of the contraction.|Encounter 1 (day 1) and Encounter 2 (Month 14)|All subjects enrolled in the study||mmHg*s*cm||Standard Deviation|Mean
77098|NCT01031004|Primary|Average Wear Time||after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||hours per day||Standard Deviation|Mean
77099|NCT01031004|Primary|Average Wear Time||after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||hours per day||Standard Deviation|Mean
77100|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.|after 1 month|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77101|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.|after 1 week|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77102|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77103|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77104|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77105|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77106|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77107|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77108|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77109|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77316|NCT01028911|Secondary|Maximum Plasma Concentration (Cmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||ng/mL||Standard Deviation|Geometric Mean
77111|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77112|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77113|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77114|NCT01031004|Primary|Corneal Edema at Month 1|Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77115|NCT01031004|Primary|Slit Lamp Findings - Corneal Edema|Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.||eyes|Participants||Number
77116|NCT01030965|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28|Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.|Baseline, Day 1, and Day 28|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.||Liters||Standard Error|Least Squares Mean
77117|NCT01030965|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline, Day 1, and Day 28|ITT Population. Participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.||Liters||Standard Error|Least Squares Mean
77118|NCT01030965|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline and Day 29|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 29.||Liters||Standard Error|Least Squares Mean
77119|NCT01030952|Secondary|Change in Percent of 24 Hour Hyperglycemic Measurements|Measures/compares changes in percentage of hyperglycemia (>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.||percent of measurements||Standard Deviation|Mean
77120|NCT01030952|Secondary|The Percent of 24 Hour Hypoglycemic Measurements|Measures/compares changes in percentage of hypoglycemia(<3.9mmol/l or <70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent-to-treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. During different time points, participants with observations at that time point were included in the analysis||percent of measurements||Standard Deviation|Mean
77121|NCT01030952|Secondary|Change in Mean Amplitude of Glycaemic Excursion (MAGE)|mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||mmol/l||Standard Deviation|Mean
77122|NCT01030952|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 3. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||millimoles per litre (mmol/l)||Standard Deviation|Mean
77123|NCT01030952|Secondary|Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint|TG change in blood lipids level from baseline to endpoint|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.||millimoles per litre (mmol/l)||Standard Deviation|Mean
77124|NCT01030952|Secondary|Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point|time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.||millimoles per litre (mmol/l)||Standard Deviation|Mean
77125|NCT01030952|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|change in LDL-C at 0, 30 and 120 minutes|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||millimoles per litre (mmol/l)||Standard Deviation|Mean
77126|NCT01030952|Secondary|Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline|This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.||(μU/ml)||Standard Deviation|Mean
77127|NCT01030952|Secondary|Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment|GSA levels were to be determined by CGMS at 7:00~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.||percent||Standard Deviation|Mean
77128|NCT01030952|Secondary|Changes in 24 Hour Glucose Area Under Curve (AUCpp)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|baseline, end of study (3 weeks)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol*min/L||Standard Deviation|Mean
77129|NCT01030952|Secondary|Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)|The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability.|baseline, 3 weeks (end of study)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||millimoles per litre (mmol/l)||Standard Deviation|Mean
77130|NCT01030952|Secondary|Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.|Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline||mmol/l||Standard Deviation|Mean
77131|NCT01030952|Secondary|Change in Mean Blood Glucose (MBG)|The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately.|baseline and at 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline||millimoles per litre (mmol/l)||Standard Deviation|Mean
77132|NCT01030952|Secondary|Change in Incremental Glucose Peak (IGP) From Baseline|Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.||millimoles per litre (mmol/L)||Standard Deviation|Mean
77133|NCT01030952|Primary|Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)|"The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.~0-4 hours AUC were calculated using trapezoid methods."|3 weeks (end of study) minus baseline|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.||millimoles hours per litre (mmol*hr/L)||95% Confidence Interval|Least Squares Mean
77134|NCT01030757|Secondary|Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.||1 year|Study was terminated due to low accrual; no results to report.|||||
77135|NCT01030757|Primary|Tumor Response Rate (Complete Response + Partial Response).||1 year|Study was terminated due to low accrual; no results to report|||||
84379|NCT00961662|Secondary|Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit||6 months||||||
77136|NCT01030718|Secondary|Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling|Blood samples for pharmacokinetic analysis of Dasatinib BID that will contribute to population pharmacokinetic modeling were collected.|At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose|There was no individual PK analysis done for this study; analyses were integrated and evaluated as a part of population PK of this drug.||participants|||Number
77137|NCT01030718|Secondary|Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)|Point mutations of BCR-ABL detected or undetected in the Quantitative real-time PCR polymerase chain reaction (RQ-PCR) products|At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.|Treated participants||participants|||Number
77138|NCT01030718|Secondary|Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement|Detectable BCR-ABL transcripts (b3a2, b2a2 or minor) >=2.0 log copy/micrograms RNA, as measured by real-time quantitative PCR (RQ-PCR) at baseline and best achievement post-dose.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation|Treated participants||participants|||Number
77139|NCT01030718|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of OHR was computed only for participants whose best response was CHR or a MaHR or MiHR & was measured from the first day hematologic response criteria were met, provided they were confirmed 28 days later until the date of PD or death. Median duration of OHR in the CML-AP/BP arm was not yet reached.||Days||Full Range|Median
77140|NCT01030718|Secondary|Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Time to OHR = time from first dose of dasatinib until the first day measurement criteria are first met for hematologic response provided they were confirmed 28 days later. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|OHR was computed only for subjects whose best response is CHR or MaHR or Minor HR (MiHR).||Days||Full Range|Median
77141|NCT01030718|Secondary|Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response (MaHR)=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of MaHR was computed only for advanced diseases subjects whose best response is a MaHR and was measured from the first day MaHR criteria are met, provided they were confirmed 28 days later until the date of PD or death. Median Duration of MaHR was not yet reached in the CML-AP/BP arm.||Days||Full Range|Median
77142|NCT01030718|Secondary|Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Time to major hematologic response (MaHR)=time from first dose of dasatinib until the first day the measurement criteria for MaHR and is computed only for advanced diseases subjects whose best response is a major hematologic response. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving MaHR||Days||Full Range|Median
77143|NCT01030718|Secondary|Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|Duration of CHR was computed only for chronic phase CML subjects whose best response is CHR. It was measured from the first day complete hematologic response criteria are met provided they are confirmed 28 days later until the date treatment is discontinued due to PD or death. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR. Duration of CHR in the CML AP/BP arm has not yet been reached.||Days||Full Range|Median
77144|NCT01030718|Secondary|Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|CHR=all of the following criteria: WBC ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. Time to CHR=time from first dose of dasatinib until the first day criteria for CHR are met provided they are confirmed 28 days later and was computed only for chronic phase CML subjects whose best response is CHR. Subjects who neither progressed nor died were censored at date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR||Days||Full Range|Median
77145|NCT01030718|Secondary|Participants With Ph+ ALL: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=(see Outcome Measure 14, above). NEL=WBC ≤ULN; BM blasts ≤5%; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; <20% peripheral blood basophils; no extramedullary involvement; and at least 1 of the following: ANC ≥500/mm3 and <2000/mm3 or platelets ≥20,000/mm3 and <100,000/mm3. Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated Ph+ ALL participants||Percentage of Participants||95% Confidence Interval|Number
77146|NCT01030718|Secondary|Participants With CML-AP/BP: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=WBC <ULN; absolute neutrophil count (ANC) >1,000/mm3; platelets >100,000/mm3; no blasts or promyelocytes in peripheral blood; BM blasts ≤5%; <5% myelocytes + metamyelocytes in peripheral blood; <20% basophils in peripheral blood; no extramedullary involvement. NEL=(see Outcome Measure 15, below). Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-AP/BP participants||Percentage of Participants||95% Confidence Interval|Number
77147|NCT01030718|Secondary|Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count (WBC) ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-CP participants||Percentage of Participants||95% Confidence Interval|Number
77148|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-AP/BP arm.||Days||Full Range|Median
77149|NCT01030718|Secondary|Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-CP arm.||Days||Full Range|Median
77150|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.||Days||Full Range|Median
77151|NCT01030718|Secondary|Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.||Days||Full Range|Median
77152|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of PD or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-AP/BP group.||Days||Full Range|Median
77153|NCT01030718|Secondary|Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of progressed disease (PD) or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-CP group.||Days||Full Range|Median
77154|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR||Days||Full Range|Median
77155|NCT01030718|Secondary|Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),|Participants achieving CCyR||Days||Full Range|Median
77559|NCT01026805|Secondary|Fluid Deficit Per Procedure|mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.|at time of treatment|||mL||Full Range|Mean
77156|NCT01030718|Secondary|Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated Ph+ ALL participants||Percentage of Participants||95% Confidence Interval|Number
77157|NCT01030718|Secondary|Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated CML-AP/BP participants||Percentage of Participants||95% Confidence Interval|Number
77158|NCT01030718|Secondary|Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Philadelphia positive [Ph+] Cells in Metaphase in BM).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Treated CML-CP participants||Percentage of Participants||95% Confidence Interval|Number
77159|NCT01030718|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation|All treated participants. Number of deaths represents all reported deaths, including after the study end. For AEs leading to discontinuation: 4 in CML-CP=1 insufficient effect (IE) +3 AEs in Participant Flow (PF); 7 in CML-AP/BP= 1 death + 5 AEs + 1 IE in PF; 4 in Ph+ALL=3 IE + 1AE in PF.||participants|||Number
77160|NCT01030666|Secondary|Radiographic Bony Fill 12 Months After Surgery (Reduction of Distance Cemento-enamel Junction [CEJ] to Bony Defect [BD])|If the CEJ was destroyed by the restorative treatment the margin of the restoration was taken as landmark. BD is defined as most coronal point where the periodontal ligament space shows a continuous width. If no periodontal ligament space could be identified, the point where the projection of the alveolar crest (AC) crossed the root surface was taken as a landmark. If both structures could be identified at one defect, the point defined by the periodontal ligament was used as BD and the crossing of the silhouette of the alveolar crest with the root surface was defined as AC. If several bony contours could be identified, the most apical one that crossed the root was defined as the BD and the most coronal one as AC.|Baseline to 12 months after surgery|ITT population. Missing data due to losing to follow-up: last observation carried forward. Patients whose radiographs could not be analysed were excluded.||mm||Standard Deviation|Mean
77161|NCT01030666|Primary|Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery|Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.|Baseline to 6 months after surgery|per protocol analysis: all participants who attended the 6 months re-examination||mm||Standard Deviation|Mean
77162|NCT01030653|Secondary|The Area Under the Curve Over the Dosing Interval for All Participants While on the High Dose and Low Dose Interventions.||12 hours|||hour*milligram/Liter||95% Confidence Interval|Geometric Mean
77163|NCT01030653|Primary|Geometric Mean Ratio of the AUC Between the High and Low Dose Voriconazole|AUC is the area under the concentration-time curve. The Geometric Mean Ratio and 90% confidence interval around this value permit an assessment of the bioequivalence of two dosing regimens in the same group. The geometric mean is computed based on the ratio of the AUC value from the high dose compared to the AUC value from the low dose for each individual. This ratio provides a more robust interpretation of the differences between the two dosing arms because each individual serves as their own control.|14 days|This is a comparison of the same group analyzed through a cross-over design of two voriconazole dosing regimens||Ratio||90% Confidence Interval|Number
77164|NCT01030653|Primary|Steady-State Cmax and Cmin of Two Voriconazole Dosing Regimens|"Cmax is the maximum concentration, and Cmin is the minimum concentration. These measurements are based on analysis of plasma. The units shown are milligrams of voriconazole per liter of plasma. The two dosing regimens are:~a loading dose (400 mg x 2 doses, day 1) and maintenance doses (200 mg every 12 hours x 7 doses) in obese subjects.~a loading dose (400 mg x 2 doses, day 1) and maintenance doses (300 mg every 12 hours x 7 doses) in obese subjects."|Day 5|The same subjects were analyzed in a cross-over design at two dose levels||mg/L||95% Confidence Interval|Mean
77165|NCT01030458|Secondary|Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up|This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)|6 months follow-up after randomization|||participants|||Number
77166|NCT01030458|Secondary|Side-effects to Study Medications||6 months follow-up after randomization|||participants|||Number
77167|NCT01030458|Secondary|Time to Blood Pressure Control|The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.|6 months follow-up after randomization|||weeks||Inter-Quartile Range|Median
77168|NCT01030458|Primary|Sitting Systolic Blood Pressure on Automated Measurement|Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.|6 months follow-up after randomization|The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.||mmHg||Standard Deviation|Mean
77169|NCT01029925|Primary|Response Rate by RECIST Criteria of Oral Dichloroacetate in Patients With Recurrent and/or Metastatic and Pretreated Breast and Non-small Cell Lung Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|upto 72 days|Intent to treat analysis was performed. Zero patients achieved complete or partial response in this study.||participants|||Number
77170|NCT01029886|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.||events per subject-year||Standard Error|Mean
77171|NCT01029886|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26|Change in DBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmHg||Standard Error|Least Squares Mean
77172|NCT01029886|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|Change in SBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmHg||Standard Error|Least Squares Mean
77173|NCT01029886|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||ratio||Standard Error|Least Squares Mean
77174|NCT01029886|Secondary|Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|Change in HDL-C from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmol/L||Standard Error|Least Squares Mean
77175|NCT01029886|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in total cholesterol from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmol/L||Standard Error|Least Squares Mean
77176|NCT01029886|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||kg||Standard Error|Least Squares Mean
77177|NCT01029886|Secondary|Change in Fasting Serum Glucose From Baseline to Week 26|Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||mmol/L||Standard Error|Least Squares Mean
77178|NCT01029886|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 26|Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. Missing data at endpoint was imputed using last observation carried forward approach.||percentage of patients|||Number
77179|NCT01029886|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population: all patients who were randomized and received study drug. All observed data from all scheduled visits (including early termination visits) were included in the mixed-model repeated measures (MMRM) analysis. Data collected at the early termination visits were mapped into the following scheduled visits.||percentage of total hemoglobin||Standard Error|Least Squares Mean
77180|NCT01029795|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks.|No participants had data analyzed due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
77248|NCT01029535|Secondary|Physician Assessment of Global Aesthetic Improvement Score (GAIS)|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||score on a scale||Standard Deviation|Mean
77181|NCT01029795|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
77182|NCT01029795|Secondary|Mean Afternoon Dose of LY2599506 During the 12-week Treatment Period|Assigned afternoon dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
77183|NCT01029795|Secondary|Mean Morning Dose of LY2599506 During the 12-week Treatment Period|Assigned morning dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
77184|NCT01029795|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to the insufficient sample size.||beats per minute (bpm)||Standard Deviation|Mean
77185|NCT01029795|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAJ was terminated after enrolling 38 participants. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes per 30 days|||Number
77186|NCT01029795|Secondary|Area Under the Concentration-Time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (Pop PK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.||nanograms per milliliter times hour||Standard Deviation|Mean
77187|NCT01029795|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (PopPK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
77188|NCT01029795|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.||percentage of participants|||Number
77189|NCT01029795|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
77190|NCT01029795|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||millimoles per liter (mmol/L)||Standard Deviation|Mean
77191|NCT01029795|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||kilograms (kg)||Standard Deviation|Mean
77192|NCT01029795|Secondary|Number of Hypoglycemic Episodes During 12-week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant felt s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes|||Number
77193|NCT01029795|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBP minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||mm Hg||Standard Deviation|Mean
77194|NCT01029795|Secondary|Change From Baseline in the Perceptions About Medications – Diabetes (PAM-D) Questionnaire at 12 Weeks and 16 Weeks|"PAM-D assesses participants' perceptions about their diabetes medications during the past month. Responses ranged from None of the time, to All of the time. The sum of all items in the scale equals the scale score, which was linearly transformed to a 0 (least favorable state) to 100 (most favorable state). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed."|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77195|NCT01029795|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77196|NCT01029795|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77197|NCT01029795|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77198|NCT01029795|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77199|NCT01029795|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.||millimoles per liter (mmol/L)||Standard Deviation|Mean
77560|NCT01026805|Secondary|Fluid Volume Per Procedure|mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.|at time of treatment|||mL||Full Range|Mean
77200|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
77201|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.||percentage of beta cell function (%B)||Standard Deviation|Mean
77202|NCT01029795|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.||milliseconds (ms)||Standard Deviation|Mean
77203|NCT01029795|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
77204|NCT01029730|Secondary|Number of Participants With Adverse Events as a Measure of Safety.|Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in >1 patient|Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.|All patients||participants|||Number
77205|NCT01029730|Secondary|Median Progression-free Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.|||months||95% Confidence Interval|Median
77206|NCT01029730|Secondary|Overall Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At 3 and 6 months during treatment, then 6 months post-treatment.|All patients evaluable for response.||percentage of evaluable participants|||Number
77207|NCT01029730|Primary|Complete Response Rate|Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.|18 months|All evaluable patients||percentage of evaluable participants|||Number
77208|NCT01029704|Secondary|Changes From the Baseline in the Urinary Glucose Excretion at End of 28 Days|Urinary glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (day 1) from urinary glucose level at end of treatment (day 28) (i.e urinary glucose level on day 28 minus urinary glucose level on Day 1).|baseline (day 1) and 28 days|||g/24h||Standard Deviation|Mean
77209|NCT01029704|Secondary|Changes From the Baseline in the Hemoglobin A1c (HbA1c) at End of 28 Days|HbA1c levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the HbA1c level during the study period was calculated by reducing the baseline HbA1c level (day 1) from HbA1c level at end of treatment (day 28) (i.e HbA1c level on day 28 minus HbA1c level on Day 1).|baseline (day 1) and 28 days|||Percent||Standard Deviation|Mean
77210|NCT01029704|Secondary|Change From the Baseline in the Body Weight at End of 28 Days|Body weight was measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the body weight during the study period was calculated by reducing the baseline body weight (day 1) from body weight at end of treatment (day 28) (i.e body weight on day 28 minus body weight on Day 1).|baseline (day 1) and 28 days|||Kg||Standard Deviation|Mean
77211|NCT01029704|Primary|Changes From the Baseline in the Fasting Plasma Glucose at End of 28 Days|Fasting glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the fasting plasma glucose level during the study period was calculated by reducing the baseline glucose level (day 1) from glucose level at end of treatment (day 28) (i.e glucose level on day 28 minus glucose level on Day 1).|baseline (day 1) and 28 days|||mg/dL||Standard Deviation|Mean
77227|NCT01029652|Secondary|Patient’s Global Assessment of Response to Treatment|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
77561|NCT01026805|Secondary|Treatment Time Per Patient|mean morcellation(division into and removal of small pieces, as of tissue) time per patient|at time of treatment|||minutes||Full Range|Mean
77212|NCT01029652|Secondary|Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
77213|NCT01029652|Secondary|Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
77214|NCT01029652|Secondary|Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
77215|NCT01029652|Secondary|Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
77216|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
77217|NCT01029652|Secondary|Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.||Percentage of participants|||Number
77218|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.||Participants|||Number
77219|NCT01029652|Secondary|Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab|Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included||mg/L||Standard Deviation|Mean
77220|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab|High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included||mg/L||Standard Deviation|Mean
77221|NCT01029652|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||New flares per patient per year||Standard Deviation|Mean
77222|NCT01029652|Secondary|Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||days||95% Confidence Interval|Median
77223|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|7 days post dose (randomization), 24 weeks post-dose|Full Analysis Set includes all patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
77224|NCT01029652|Secondary|Physician’s Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of patients in each category is reported.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)|Full Analysis Set (FAS): All patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
77225|NCT01029652|Secondary|Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
77226|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.||Participants|||Number
77317|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||ng*hr/mL||Standard Deviation|Geometric Mean
77228|NCT01029652|Secondary|Physician’s Global Assessment of Response to Treatment|The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s assessments (pain intensity [Visual Analog Scale and Likert scale] and patient’s global assessment of response to treatment).|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.||Percentage of participants|||Number
77229|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. Patients with baseline flare and data at 72 hours post-dose in core and patients with a new flare and data at 72 hours post-dose for the last post-baseline flare (during 24 weeks overall) were included in this analysis.||mg/L||95% Confidence Interval|Least Squares Mean
77230|NCT01029652|Secondary|Percentage of Participants Who Took Rescue Medication|Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.|during 12 weeks core, 24 weeks overall|"The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. 12 weeks:Core consisted of patients taking rescue medication during baseline flare of Core study and 24 weeks:Overall consisted of patients who took rescue medication during last post-baseline flare during 24 weeks."||Percentage of participants|||Number
77231|NCT01029652|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|7 days last post-baseline flare (during 24 weeks)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations at 7 days last post-baseline flare were included in this analysis.||mg||Standard Deviation|Mean
77232|NCT01029652|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||mm||Standard Error|Least Squares Mean
77233|NCT01029652|Secondary|Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)|Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|Last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with baseline and last post-baseline observations were included in this analysis.||Percentage of participants|||Number
77234|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was applied to impute post dose measurements.||mm||Standard Error|Least Squares Mean
77235|NCT01029652|Secondary|Time to First Intake of Rescue Medication After the Last Post Baseline Flare.|The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations 72 hours post-dose for the last post-baseline flare during 24 weeks were included in analysis.||Hours||95% Confidence Interval|Median
77236|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||New flares/patient/24 weeks||Standard Deviation|Mean
77237|NCT01029652|Secondary|Time to First New Flare|"Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Days||95% Confidence Interval|Median
77238|NCT01029652|Secondary|SF36 Physical Function Score at Week 12|The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participant observations at Week 12 were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
77239|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||New flares/patient/12 weeks||Standard Deviation|Mean
77240|NCT01029652|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Percentage of participants|||Number
77241|NCT01029652|Secondary|Percentage of Participants With Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
77242|NCT01029652|Secondary|Time to Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Hours||95% Confidence Interval|Median
77243|NCT01029652|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|From baseline to 7 days post dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.||Hours||95% Confidence Interval|Median
77244|NCT01029652|Primary|Time to First New Flare|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.||Days||95% Confidence Interval|Median
77245|NCT01029535|Secondary|Percentage of Participants Satisfied or Very Satisfied With the Treatment|Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.|Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
77246|NCT01029535|Secondary|Change From Baseline in the Subject’s Self-Perception of Age (SPA)|The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||years||Standard Deviation|Mean
77247|NCT01029535|Secondary|Subject’s Assessment of Global Aesthetic Improvement Score (GAIS)|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||score on a scale||Standard Deviation|Mean
77249|NCT01029535|Secondary|Change From Baseline in the MFVDS Score|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||score on a scale||Standard Deviation|Mean
77250|NCT01029535|Secondary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator’s Wrinkle Assessment Scale (WAS)|The physician assessed the left side and the right side of the participant’s face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
77251|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 104|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77252|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 78|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77253|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 52|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77254|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 104|The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77255|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 78|The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77256|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 52|The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77257|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77258|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77259|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of participants|||Number
77260|NCT01029535|Primary|Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 8|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
77261|NCT01029535|Primary|Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 4|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 4|ITT population included all enrolled participants who received at least one application of VOLUMA™.||percentage of particpants|||Number
77318|NCT01028911|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||hours||Full Range|Median
77262|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 8|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of particpants|||Number
77263|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 4|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
77264|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 8|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
77265|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 4|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.||percentage of participants|||Number
77266|NCT01029340|Secondary|Part C - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|at the time of surgery|ITT||Participants|||Number
77267|NCT01029340|Secondary|Part B - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|An average of 1 month after start of treatment|ITT||Participants|||Number
77268|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|before and 3 weeks after surgery|ITT||Participants|||Number
77269|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 12 months after drug administration|ITT||Participants|||Number
77270|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 4 weeks after drug administration|ITT||Participants|||Number
77271|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|before and 3 weeks after surgery|ITT||Participants|||Number
77272|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 12 months after drug administration|ITT||Participants|||Number
77273|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 6 weeks after drug administration|Safety population||Participants|||Number
77274|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|before and 3 weeks after surgery|ITT||Participants|||Number
77275|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 12 months after drug administration|Safety population||Participants|||Number
77276|NCT01029340|Secondary|Part A - Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 6 weeks after first injection of study drug|Safety population||Participants|||Number
77277|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Utility Index as Measured by EQ–5D Questionaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. 1.0 = Best possible score, -0.594 = Worst possible score. Positive changes from baseline indicate an improvement and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 61 of the 62 participants had data available for the Utility Index of the EQ-5D questionnaire at Month 12.||Scores on a scale||Full Range|Median
77278|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Quality of Life (QoL) as Measured by Transformed Total Score of Haemo-QoL Questionnaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. the scoring system has 100 points. 0 is the worst possible score. 100 is the best possible score. Positive changes from baseline indicate an improvement in quality of life and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 51 of the 62 participants had data available for the 12-month QoL analysis.||Scores on a scale||Full Range|Median
77279|NCT01029340|Secondary|Part B - Control of Bleeding as Measured by the Number of Injections Required to Treat a Bleed|The number of injections needed by participants to stop a bleed|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.||Injections|Participants|Full Range|Median
77280|NCT01029340|Secondary|Part B - Annualized Number of Bleeds in Each 6-month Potency Assignment Period|The annualized number of bleeds experienced by participants in each of the two treatment periods|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.||Bleeds||Inter-Quartile Range|Median
77281|NCT01029340|Secondary|Part B - The in Vivo Recovery Values of Human Factor VIII (FVIII)|The amount of Factor VIII found in blood samples taken after the injection of the study drug at the beginning of the CS/EP treatment period.|15-30 minutes after the injection|ITT. 1 measurement was taken in all participants at the start of the CS/EP labelled treatment period (CS/ADJ labelled treatment was experimental and will not be used for the future commercial drug, so no measurements were taken). Note: Only 59 of the 62 participants had valid recovery data.||Kg/dL||Inter-Quartile Range|Median
77282|NCT01029340|Primary|Part B - Annualized Number of Total Bleeds|The annualized number of bleeds experienced by participants|12 months after randomization|Intent to treat (ITT)||Bleeds||Inter-Quartile Range|Median
77283|NCT01029340|Primary|Part A - Half-life (t 1/2)|To examine the PK characteristics of BAY81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.|PK Analysis Population||Hours (h)||Geometric Coefficient of Variation|Geometric Mean
77284|NCT01029340|Primary|Part A - Area Under the Drug Concentration-time Curve (AUC)|To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.|PK Analysis Population||Int.units x hours/deciliters (IU*h/dL)||Geometric Coefficient of Variation|Geometric Mean
77285|NCT01029262|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations, Concomitant Procedures/Surgeries and the Differences Between Treatment Arms|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Up to 5 years||05/2017||||
77286|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."||percentage of participants|||Number
77287|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point (indicated by n) are included."||percentage of participants|||Number
77288|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point (indicated by n) are included."||percentage of participants|||Number
77305|NCT01029262|Secondary|Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML)|Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact.|Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure to study drug was 1158 days|Intent to treat population includes all participants who were randomized and received either Lenalidomide or Placebo. One participant in the placebo arm was diagnosed as having AML before enrollment and was excluded from all analyses of progression to AML.||years||95% Confidence Interval|Median
77289|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). Improvement means at least 10 points better compared to baseline."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||percentage of participants|||Number
77290|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Improvement means at least 10 points better compared to baseline|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."||percentage of participants|||Number
77291|NCT01029262|Secondary|Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
77292|NCT01029262|Secondary|Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
77293|NCT01029262|Secondary|Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Physical Functioning was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
77319|NCT01028911|Secondary|Maximum Serum Concentration (Cmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||nanogran per millileter (ng/mL)||Standard Deviation|Geometric Mean
77294|NCT01029262|Secondary|Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
77295|NCT01029262|Secondary|Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||95% Confidence Interval|Least Squares Mean
77296|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
77297|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
77298|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Physical Functioning Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
77306|NCT01029262|Secondary|Time to 56-Day RBC-Transfusion-independent Response as Determined by the Sponsor|The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period – the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.|From the first dose of study drug to Day 56|The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.||weeks||Full Range|Median
78012|NCT01020123|Secondary|Haemoglobin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|population is safety analysis set regardless of rescue, using the observed cases (see table 197 in CSR)||g/dL||Standard Deviation|Mean
77299|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n are included)."||units on a scale||Standard Deviation|Mean
77300|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."||units on a scale||Standard Deviation|Mean
77301|NCT01029262|Primary|Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|"The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive rolling 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder."|Up to 49 months; Up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Analysis population includes ITT participants with an erythroid gene expression signature with a positive response||percentage of participants|||Number
77302|NCT01029262|Secondary|Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A participant was considered compliant at a visit if at least 15 out of the QLQ-C30 items in the questionnaire were checked.|Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014|Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Data is available up to Week 48 due to small sample after that.||percentage of participants|||Number
77303|NCT01029262|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|"A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.~A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|From the first dose of study drug through 28 days after discontinuation from the study treatment; up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Safety population includes all patients who received at least 1 dose of study drug.||participants|||Number
77304|NCT01029262|Secondary|Kaplan Meier Estimate for Overall Survival (OS)|Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive.|Up to 49 months; From randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Intent to treat population was all participants who were randomized.||years||95% Confidence Interval|Median
77314|NCT01029054|Primary|The Maximum Tolerated Dose (MTD) of Carfilzomib|Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.|6 Months|Of the 53 patients enrolled, 35 were entered into the Phase I portion of the study.||mg/m^2|||Number
77315|NCT01028911|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||hours||Full Range|Median
77307|NCT01029262|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on Modified International Working Group (IWG) 2006 Criteria|"A participant was considered as having achieved an erythroid response if the participant either:~- had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less <1.5 g/dL). The duration of Hgb increase is from the date of a first ≥1.5 g/dL increase to the last date when Hgb value still have a ≥1.5 g/dL increase.~OR~- had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.~The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9 g/dL or less may be used in this response assessment."|Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure on study drug was1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.||percentage of participants|||Number
77308|NCT01029262|Secondary|Kaplan Meier Estimates of Duration of 56-day RBC TI Response as Determined by the Sponsor|"The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):~for those who received a subsequent RBC transfusion after the response starts, the duration of response was not censored, and was calculated as response duration = last day of response – first day of response +1 where the last day of response was defined as 1 day before the first RBC transfusion which was given at 56 days or more after the response starts.~for those who did not receive a subsequent RBC transfusion after the response started, the end day of the response was censored and duration of the response was calculated as response duration = date of last RBC transfusion assessment – first day of response+ 1. A responder was a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first study drug treatment period"|Up to 49 months; from randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.||weeks||95% Confidence Interval|Median
77309|NCT01029262|Post-Hoc|Percentage of Participants Who Achieved an Erythroid Response Based on Original IWG 2006 Criteria|"A participant was considered as having achieved an erythroid response when:~- a Hgb increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that had also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe can be less than a 1.5 g/dL). The duration of Hgb increase is from the date of a first ≥1.5 g/dL increase to the last date when Hgb value still have a ≥1.5 g/dL increase.~OR~- had an absolute reduction of 4 RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.~The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9.5 g/dL or less may be used in this response assessment."|Up to 49 months; from randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Intent to treat population includes all participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
77310|NCT01029262|Secondary|Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor|The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive “rolling” 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.|Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.||percentage of participants|||Number
77311|NCT01029262|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive “rolling” 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose|Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.||percentage of participants|||Number
77312|NCT01029054|Primary|The Percentage of Patients That Achieve a Response to Treatment|"The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined.~sCR is defined as:~Negative immunofixation on the serum and urine and~Disappearance of any soft tissue plasmacytomas and~< 5% plasma cells in bone marrow and~Normal SFLC ratio and~Absence of clonal cells in bone marrow~VGPR is defined as:~Serum and urine M-protein detectable by immunofixation but not on electrophoresis or~≥ 90% reduction in serum M-component with urine M-component < 100 mg per 24 hours~PR is defined as:~≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours~If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required"|4 Months After Treatment Start|||percentage of patients|||Number
77313|NCT01029054|Secondary|The Percentage of Patients Alive Without Progression|"The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment.~Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia."|12 Months and 24 Months Post Treatment|||percentage of patients|||Number
98378|NCT00829426|Primary|Bioequivalence Based on AUC0-inf|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period|||ng*h/mL||Standard Deviation|Mean
77320|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
77321|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Follow-up|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77322|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 30|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77323|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 25|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77324|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 20|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77325|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 15|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77326|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 10|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77327|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 5|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77328|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Follow-up|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77329|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 30|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77330|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 25|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77389|NCT01027351|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, Booster response.||AU/mL||95% Confidence Interval|Geometric Mean
98379|NCT00829426|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 72 hour period|||ng/mL||Standard Deviation|Mean
77331|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 20|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77332|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 15|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77333|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 10|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77334|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 5|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77335|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Follow-up|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77336|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 30|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 30|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77337|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 25|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77338|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 20|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77566|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 1|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set||Participants|||Number
77339|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 15|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77340|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 10|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77341|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 5|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77342|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline|Safety population included all participants who took at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
77343|NCT01028911|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
77344|NCT01028911|Primary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/>1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs), urine epithelial cells (>=6 high-powered field), urine bacteria >20 high-powered field; qualitative urine glucose, ketones, protein values >=1 in urine dipstick test. Total number of participants with any laboratory abnormalities was reported.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
77345|NCT01028911|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of >=300 milliseconds (msec), maximum QRS interval >=200 msec, maximum fridericia’s corrected QT (QTcF) interval >=500 msec, PR interval or QRS interval increase from baseline >=25 percent (%) or 50 percent (%), QTCF interval increase from baseline 30 to 60 msec or >=60 msec.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
77346|NCT01028911|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (SBP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm, standing pulse rate <40 bpm or >140 bpm. Maximum increase or decrease from baseline in supine (Su) and standing (St) SBP >=30 mmHg and maximum increase or decrease from baseline in supine and standing DBP >=20 mmHg.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.||participants|||Number
77562|NCT01026792|Primary|Objective Response Rate|Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1|Up to 3 years|Patients evaluable for response||percentage of patients with response||95% Confidence Interval|Number
77563|NCT01026454|Secondary|Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.||28 weeks||||||
77347|NCT01028820|Primary|Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version|The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS—PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant.|"Baseline (Pre-Dose) to 8 Weeks (Post-Dose)"|All randomized participants' scores were analyzed using the PDD-CYBOCS measure. Higher values reflect worse outcomes. Subscales are added to compute the total score (total score does not include compulsion free-interval and peculiarity of the behavior.||Scores on a scale||Standard Deviation|Mean
77348|NCT01028820|Secondary|Total Repetitive Behavior Scale - Revised (RBS_R)|"The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales.~The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129."|baseline week 0, 8 weeks|All randomized participants' scores were analyzed using the RBS-R measure. Higher values reflect worse outcomes (greater symptom severity). Subscales are added to compute the total score.||units on a scale||Standard Deviation|Mean
77349|NCT01027364|Primary|Comparison of Annualized Bleeding Rates|Estimated with a factor for arm, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.||episodes per participant per year||95% Confidence Interval|Number
77350|NCT01027364|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed pharmacokinetic (PK) sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.||episodes per participant per year||Inter-Quartile Range|Median
77351|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in D-dimer|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.||ng/mL||Standard Deviation|Mean
77352|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Thrombin-antithrombin (TAT) Complex|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.||ng/mL||Standard Deviation|Mean
77353|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Prothrombin Split Fragments 1+ 2 (F 1+2)|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.||pmol/L||Standard Deviation|Mean
77390|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 & 42 months .|1 month after each booster/ vaccine dose|The analysis was done on the MITT population, booster response.||AU/mL||95% Confidence Interval|Geometric Mean
77354|NCT01027364|Secondary|Number of Participants With Clinically Relevant Abnormalities or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFIXFc dose. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; a table was not generated for participants in the perioperative management/surgical arm (Arm 4). n=participants with a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, SBP, and DBP.||participants|||Number
77355|NCT01027364|Secondary|Time to 1% and 3% FIX Activity|Time to reach 1 or 3 IU/dL (%) after a single dose. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||days||95% Confidence Interval|Geometric Mean
77356|NCT01027364|Secondary|Incremental Recovery|IU/dL rise in plasma per IU/kg drug administered. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
77357|NCT01027364|Secondary|Volume in Steady State (Vss)|Volume of distribution at steady state. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||mL/kg||95% Confidence Interval|Geometric Mean
77358|NCT01027364|Secondary|Mean Residence Time (MRT)|The average time for all the drug molecules to reside in the body. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||hours||95% Confidence Interval|Geometric Mean
77359|NCT01027364|Secondary|Clearance (CL)|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||mL/h/kg||95% Confidence Interval|Geometric Mean
77360|NCT01027364|Secondary|Half Life (t1/2) Alpha and t1/2 Beta|Time required for the concentration of the drug to reach half of its original value. Alpha and beta half-life indicate distribution and elimination half-life in a two-compartment PK model. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||hours||95% Confidence Interval|Geometric Mean
77361|NCT01027364|Secondary|Area Under the Curve (AUC) Per Dose|Dose normalized area under the drug concentration-time curve. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
77362|NCT01027364|Secondary|Maximum Concentration (Cmax)|Maximum concentration during a dosing interval. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.||IU/dL||95% Confidence Interval|Geometric Mean
77363|NCT01027364|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||surgeries|Participants||Number
77364|NCT01027364|Primary|Incidence Rate of FIX Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% CI were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFIXFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFIXFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of of rFIXFc and who had a valid inhibitor test; n=number of participants with given number of exposure days who had a valid inhibitor test.||percentage of participants||95% Confidence Interval|Number
77365|NCT01027364|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||mL|Participants|Full Range|Median
77366|NCT01027364|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||IU/kg|Participants|Full Range|Median
77367|NCT01027364|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes including the loading dose to the end date/time of surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||injections|Participants|Full Range|Median
77368|NCT01027364|Secondary|Investigators’/Surgeons’ Assessment of Participants’ Response to rFIXFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.||responses|Participants||Number
77369|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 26 and Week 52|The Haemo-QoL, a quality of life (QoL) assessment instrument for children and adolescents with hemophilia, was administered to participants from 13- to 17-years-old. This instrument assesses domains specific to living with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline, Week 26, Week 52|No summary analysis was done for this outcome measure due to the small number of participants completing the questionnaire.|||||
77370|NCT01027364|Secondary|Haem-A-QoL Questionnaire for Adults: Change From Baseline to Week 52|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 52|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
77371|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 26|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 26|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.||units on a scale||Full Range|Median
77372|NCT01027364|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.||IU/kg||Inter-Quartile Range|Median
77373|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had evaluable efficacy assessments; n=total number of bleeds at given location.||injections||Inter-Quartile Range|Median
77374|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had at least 1 bleeding episode.||injections|Participants|Inter-Quartile Range|Median
77375|NCT01027364|Secondary|Number of Days From Last Injection to Treat a New Bleeding Episode|Please see the definition of the Efficacy Period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (bleeding episodes of this type were not evaluable). The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time. The number of days from the last injection to treat a bleed to a new bleeding episode was analyzed across all evaluable bleeding episodes per participant.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and at least 1 evaluable bleeding episode.||days|Participants|Inter-Quartile Range|Median
77564|NCT01026454|Primary|Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.|Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.|Weekly for 12 weeks per intervention|||log10 copies/mL||95% Confidence Interval|Mean
77376|NCT01027364|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.||episodes per participant per year||Inter-Quartile Range|Median
77377|NCT01027364|Secondary|Annualized Bleeding Rate by Type of Bleed (Spontaneous and Traumatic)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.||episodes per participant per year||Inter-Quartile Range|Median
77378|NCT01027364|Secondary|Average Dosing Interval For the Individualized Interval Prophylaxis Arm|Average dosing interval = sum of days in the included dosing intervals divided by the number of included intervals. Participants could have multiple prophylactic dose interval changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 2 who received at least 1 dose of rFIXFc with >=6 months on study and evaluable data.||days||Inter-Quartile Range|Median
77379|NCT01027364|Secondary|Average Weekly Dose For the Fixed Weekly Interval Prophylaxis Arm|Average weekly dose = (total IU/kg of all eligible prophylactic doses in the included intervals / total number of days in the included intervals)*7. Eligible dose = the first of the 2 doses defining the interval. Participants could have multiple prophylactic dose changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 1, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 1 who received at least 1 dose of rFIXFc with evaluable data. 'Overall' n=participants with evaluable data; 'Last 3 Months on Study' n=participants with evaluable data and >=6 months on study.||IU/kg||Standard Deviation|Mean
77380|NCT01027364|Secondary|Annualized rFIXFc Consumption Per Participant|Consumption is calculated for the efficacy period (EP). In Arms 1 and 2, the EP started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. Overall units (IU/kg) of annualized rFIXFc consumption = [Total rFIXFc IU/kg received during the EP / number of days in EP]*365.25.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data in the efficacy period. 'Overall' n=all participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=all participants in the Full Analysis Set with evaluable data and >=6 months on study.||IU/kg rFIXFc per participant per year||Standard Deviation|Mean
77381|NCT01027364|Secondary|Physicians’ Global Assessments of Participants’ Response to Treatment With rFIXFc|Physicians assessed each participant's response to rFIXFc using a 4-point scale: excellent=bleeding episodes responded to less than or equal to the usual number of injections or less than or equal to the usual dose of rFIXFc, or the rate of breakthrough bleeding during prophylaxis was less than or equal to that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis or hemostatic control required additional agents. Percentage of the total count of scale responses for all participants is presented. Multiple responses per participant are counted.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had evaluable efficacy assessments, and had nonmissing observations at time point.||percentage of responses|Participants||Number
77391|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post booster; 1 month post dose for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.||AU/mL||95% Confidence Interval|Geometric Mean
77382|NCT01027364|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had a bleeding episode; participants with a non-evaluable bleeding episode are counted in the 'number of participants analyzed,' but not the percentages.||percentage of responses|Participants||Number
77383|NCT01027364|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period|SAE=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. TESAE=SAE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOC is abbreviated in the table: Injury, Poisoning, and Procedural (IPP).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).||participants|Participants||Number
77384|NCT01027364|Primary|Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOCs are abbreviated in the table: Immune System (IS); Injury, Poisoning, and Procedural (IPP); Metabolism and Nutrition (MN); Musculoskeletal and Connective Tissue (MCT); Respiratory, Thoracic and Mediastinal (RTM); Skin and Subcutaneous Tissue (SST).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).||participants|Participants||Number
77385|NCT01027364|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TE=event present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. Related=related, possibly related, and relationship missing. Data include AEs emergent during the surgical/rehabilitation period; AE data are included in each treatment arm only for the time each participant was enrolled in that arm.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details). Participants with at least one TESAE reported are included in the TEAE count.||participants|||Number
77386|NCT01027364|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint. ULN=upper limit of normal.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; n=the number of participants with at least one post-baseline value. For this study, a table was not generated for potentially clinically significant laboratory abnormalities for participants in the perioperative management/surgical arm (Arm 4).||participants|||Number
77387|NCT01027351|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age.|The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 & 42 months or 60 & 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after any vaccination|Analysis was done on the MITT – Two Dose Catch Up Schedule population.||Number of subjects|||Number
77388|NCT01027351|Secondary|Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.|The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population population.||AU/mL||95% Confidence Interval|Geometric Mean
77392|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measure using ELISA."|28 months after last Men B vaccination; baseline for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.||AU/mL||95% Confidence Interval|Geometric Mean
77393|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after last Men B vaccination; Baseline for Naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.||AU/mL||95% Confidence Interval|Geometric Mean
77394|NCT01027351|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age.|The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.||Percentage of subjects||95% Confidence Interval|Number
77395|NCT01027351|Secondary|Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age.|The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.||Titers||95% Confidence Interval|Geometric Mean
77396|NCT01027351|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age.|The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|The analysis was done on the MITT population, 2-dose catch-up regimen.||percentage of subjects||95% Confidence Interval|Number
77397|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age.|The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.||Titers||95% Confidence Interval|Geometric Mean
77398|NCT01027351|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post -vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.||Percentages of subjects||95% Confidence Interval|Number
77399|NCT01027351|Secondary|Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.||Percentages of subjects||95% Confidence Interval|Number
77400|NCT01027351|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.||Percentages of subjects||95% Confidence Interval|Number
77401|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.||Titers||95% Confidence Interval|Geometric Mean
77402|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|"The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.~Baseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study."|1 month post - booster/ -dose 1 for Naïve|The analysis was done on the MITT population, booster response.||Percentage of subjects||95% Confidence Interval|Number
77418|NCT01027273|Secondary|Emotional Health|Number of participants diagnosed as depressed utilizing depression scale. Participant is determined to be depressed if Patient Health Questionnaire (PHQ8) ≥ 10. Scale has a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.|6 months post enrollment into trial|||participants|||Number
77403|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects .|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.||Percentage of subjects||95% Confidence Interval|Number
77404|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.||Titers||95% Confidence Interval|Geometric Mean
77405|NCT01027351|Secondary|Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.|The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported.|28 months after vaccination; baseline for naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.||percentage of subjects||95% Confidence Interval|Number
77406|NCT01027351|Secondary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.|Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after vaccination; Baseline for Naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.||Titers||95% Confidence Interval|Geometric Mean
77407|NCT01027351|Primary|Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.|The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after booster vaccination|Analysis was done on the safety population i.e all subjects who received at least one Men B vaccination and provided post-baseline safety data.||participants|||Number
77408|NCT01027351|Primary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.|"The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after last vaccination; baseline for naïve|The analysis was done on the MITT , 40 months of age, antibody persistence population.||Percentages of subjects||95% Confidence Interval|Number
77409|NCT01027351|Primary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.|Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after last vaccination; Baseline for Naïve|The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population.||Titers||95% Confidence Interval|Geometric Mean
77410|NCT01027286|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|A scoring system used to evaluate the patient's opinion about his/her knee and associated problems. Subscales include 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation (Sport/Rec), and 5) knee related quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score between 0 to 100 is calculated for each subscale. Subscale scores are generally not combined; rather, they are reported separated. Higher values represent better outcomes (i.e., less extreme symptoms).|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)||points on a scale||Standard Deviation|Mean
77411|NCT01027286|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)||points on a scale||Standard Deviation|Mean
77412|NCT01027286|Secondary|Length of Stay||day of hospital discharge|||days||Standard Deviation|Mean
77413|NCT01027286|Secondary|Daily Narcotic Usage (Morphine-equivalent mg)||daily during hospital stay (an expected average of 4 days)|||morphine-equivalent mg||Standard Deviation|Mean
77414|NCT01027286|Secondary|Preoperative & Postoperative Hemoglobin Values||within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)|||g/dL||Standard Deviation|Mean
77415|NCT01027286|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)|||participants|||Number
77416|NCT01027286|Secondary|Total Calculated Hospital Blood Loss||daily during hospital stay (an expected average of 4 days)|||mL||Standard Deviation|Mean
77417|NCT01027273|Secondary|Access to Medical Care|Number of participants who have a primary care doctor|6 months post enrollment into trial|1 missing response from Usual Care group||participants|||Number
77419|NCT01027273|Secondary|Medication Adherence|"Number of participants adherent to medications as determined with Morisky score ≥ 6 Adherence to medications was measured using the 8-item Morisky Medication Adherence Questionnaire (Morisky). The questionnaire has been validated against an objective measure of adherence and has been used in racially diverse and elderly patient samples. Scores on the questionnaire can be used to classify patients into low and high adherence groups.~Consistent with standard cut points, participants who scored less than 6 points on the Morisky were categorized as nonadherent to medications and participants who scored 6 to 8 points were categorized as adherent."|6 months post enrollment into trial|||participants|||Number
77420|NCT01027273|Secondary|Knowledge and Attitudes About Stroke Recurrence Risk||6 months post enrollment into trial||||||
77421|NCT01027273|Primary|Use of Anti-thrombotic Medication|Number of participants taking anti-thrombotic medication|6 months post enrollment into trial|||participants|||Number
77422|NCT01027273|Primary|LDL Cholesterol|Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL|6 months post enrollment into trial|||percentage of participants|||Number
77423|NCT01027273|Primary|Blood Pressure|Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg|6 months post enrollment into trial|||percentage of participants|||Number
77424|NCT01028391|Secondary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the extension study. For FAS patients with no data at Week 54, the last observed measurement during extension study was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
77425|NCT01028391|Primary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54|HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 54 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the 30-week extension study. For FAS patients with no data at Week 54, the last observed measurement during the 30-week extension study was carried forward to Week 54.||Percent HbA1c||95% Confidence Interval|Least Squares Mean
77426|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77427|NCT01028378|Primary|Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77428|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77429|NCT01028378|Primary|Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77430|NCT01028378|Primary|Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77431|NCT01028378|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77432|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77433|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77434|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D||12 month|||Percentage of Eyes|Participants|95% Confidence Interval|Number
77435|NCT01028352|Secondary|Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)|A secondary measure is the percentage of patients treated with duloxetine who experience a sustained 30% reduction in average pain score from baseline to 8 weeks. Sustained 30% reduction is defined as at least 30% reduction in 24-hour average pain severity at the 8 week endpoint, with a 30% reduction from baseline at a visit at least 2 weeks prior to the last visit, and at least 20% reduction from baseline at every visit in between.|Baseline, 2, 4 , 6 and 8 weeks|||%of participants with 30% pain reduction||95% Confidence Interval|Number
77436|NCT01028352|Primary|Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.|Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory & reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.|8 weeks|Subjects were considered evaluable for the primary endpoint if they met all eligibility criteria and took at least one dose of duloxetine||percentage of participants|||Number
77437|NCT01028300|Secondary|No Implant Related Complications||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
77438|NCT01028300|Secondary|No Re-operations, Revisions, Removals or Supplemental Fixation||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
77439|NCT01028300|Secondary|Time to Return to Active Duty||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
77565|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 2|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set||Participants|||Number
77440|NCT01028300|Primary|The Primary Endpoint of This Study is the Assessment of the Mean Oswestry Low Back Pain Disability Questionnaire (ODI) Improvement at the Twelve (12) Month and Twenty-four (24) Month Follow-up Visits Relative to Baseline.||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.|||||
77441|NCT01028222|Secondary|OS Rate|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Percentage of participants|||Number
77442|NCT01028222|Secondary|PFS Rate|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Percentage of participants|||Number
77443|NCT01028222|Secondary|Disease Control Rate (DCR)|DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Participants|||Number
77444|NCT01028222|Secondary|Time to Objective Response (TOR)|TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||months||95% Confidence Interval|Median
77445|NCT01028222|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Months||95% Confidence Interval|Median
77446|NCT01028222|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Months||95% Confidence Interval|Median
77447|NCT01028222|Secondary|Durable Overall Response Rate (DORR)|DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Participants|||Number
77448|NCT01028222|Primary|Overall Response Rate (ORR)|ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.||Participants|||Number
77449|NCT01028131|Primary|Urinary Cotinine|Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.|8 week follow-up|||participants|||Number
77450|NCT01028131|Primary|Smoking Behavior (Self-report Confirmed by Expired Breath CO)|All participants were analyzed as assigned. Total N was determined primarily by resource availability in this Stage Ib trial. Number represents number of abstinent participants in each condition.|8 week follow up|||participants|||Number
77451|NCT01028053|Secondary|The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer’s Disease (pAD) Within the Follow up Period.|Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.|Up to 36 months post flutemetamol administration.|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).||Number of subjects|||Number
77477|NCT01027780|Primary|Trail Making Test|The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively), may be utilized individually, and as a difference (B-A) or ratio (B/A) score. The Trails B/A ratio was used as an index of improvement in executive control throughout the trial, with lower scores indicating better performance.|immediate post-treatment (Time 2)|||Trails B:A score||Standard Error|Mean
77452|NCT01028053|Primary|Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer’s Disease Based on Visual Image Interpretation.|"Visual Interpretation of the PET scan by independent readers.~Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.~As the HR increases above 1, the chances of being probable Alzheimer’s Disease (pAD) also increases.~Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included)."|Up to 36 months post flutemetamol administration|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).||Ratio of visual interpretations|||Number
77453|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.|Baseline, Day 3|The ITT population was used for this secondary efficacy parameters.||Score on a scale||Standard Deviation|Mean
77454|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.|Baseline, Day 3|The PP population was used for this secondary efficacy parameters.||Score on a scale||Standard Deviation|Mean
77455|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population|The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 8|The ITT population was used in this secondary efficacy parameter.||Score on a scale||Standard Deviation|Mean
77456|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population|The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.|Baseline, Day 8|The PP population was used for this secondary efficacy parameters.||Score on a scale||Standard Deviation|Mean
77457|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population|The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 15|The ITT population was used in this secondary efficacy parameter.||Score on a scale||Standard Deviation|Mean
77458|NCT01028027|Primary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population|The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).|Baseline, Day 15|The PP population was the population used for the primary efficacy analysis.||Scores on a scale||Standard Deviation|Mean
77459|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry|Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.||milliliters per second||Inter-Quartile Range|Median
77460|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.|Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.||Milliamps||Inter-Quartile Range|Median
77478|NCT01027780|Primary|IgG Anti-KLH Antibody Response Post-treatment|Immune function--specifically, antibody response to a novel, benign antigen (an antigen to which subjects are immunologically naïve); in this case, keyhole limpet hemocyanin (KLH).|Immediate post-treatment (time 2)|||OD 405 nm||Standard Error|Mean
77501|NCT01026974|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age|The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after each vaccination|Analysis was done on the Safety population||participants|||Number
77461|NCT01028014|Primary|Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG|Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.||microvolts||Inter-Quartile Range|Median
77462|NCT01027910|Secondary|Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration.||2 years|||participants|||Number
77463|NCT01027910|Secondary|Number of Partial Responses (PR)|number of patients who demonstrated partial response to therapy as determined by RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|||participants|||Number
77464|NCT01027910|Secondary|Dose Limiting Toxicities|number of patients who experienced dose limiting toxicities|1 year|||participants|||Number
77465|NCT01027910|Primary|Maximum Tolerated Dose||up to 30 days after starting study drugs|The two groups differ in that GCSF was offered if clinically indicated in arm 1 while it was administered to all participants in arm 2.||mg/m2|||Number
77466|NCT01027897|Primary|Elimination Constant (ke)|The elimination rate constant of a drug from the central compartment|after 3rd dose of study drug|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation||per hour||Standard Deviation|Mean
77467|NCT01027897|Primary|Clearance (CL)|Clearance is the volume of drug removed from the body per unit of time (hrs).|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation||liters per hour||Standard Deviation|Mean
77468|NCT01027897|Primary|Volume of Distribution (Vd)|The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation||liters||Standard Deviation|Mean
77469|NCT01027884|Secondary|Percentage of Patients Reporting Adverse Events||52 Weeks|||percentage of patients reporting AEs|||Number
77470|NCT01027884|Secondary|Change From Baseline to Week 52 in Quality of Life Assessed by PedsQL™ Paediatric Quality of Life Inventory|"PedsQL Quality of Life Inventory contains paediatric HRQOL measurements: Physical, Emotional,Social and School Functioning.~Item Scaling:~5-point Likert scale from 0 (Never) to 4 (Almost always). 3-point scale: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Young Child (ages 5-7).~Scores are transformed on a scale from 0 to 100 ( 0=100, 1=75, 2=50, 3=25, 4=0) Total Score: Sum of all the items over the number of items answered on all the Scales.~The values reported below are overall scores on Paediatric Quality of Life Inventory in Child/Teen Report. These scores were obtained by averaging scores for all the described subscales. The overall scores range between 0-100 with 0 = worst outcome and 100= best outcome"|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with Baseline assessments.||units on a scale||95% Confidence Interval|Mean
77471|NCT01027884|Secondary|Change From Baseline to Week 52 in Muscle Strength|"The change from Baseline to Week 52 in muscle strength as measured by Hand-Held Myometry (HHM) was performed following standardized procedures. As almost all patients were non-ambulatory, only analyses of upper limb muscle strength were performed. Results for elbow flexors and for elbow extensors are reported below.The highest value of 3 consecutive measurements with an interval of at least 10 seconds were recorded.~The HHM was measured using MicroFET2, a digital hand held muscle tester. The selected unit of measure was Newtons (N)."|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with baseline assessments||Newtons||95% Confidence Interval|Mean
77472|NCT01027884|Secondary|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.||percentage of Predicted FVC||95% Confidence Interval|Mean
77473|NCT01027884|Primary|Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.||percentage||95% Confidence Interval|Geometric Mean
77474|NCT01027819|Secondary|Knee Society Score||6 months||||||
77475|NCT01027819|Primary|Rotational Angle Between Femur and Tibia||2 weeks|The rotational angle between the femur and tibia was collected by postoperative CT and asssessed between the transepicondylar angle in the femur and the vertical line of the AP axis of the tibia(the line between the insertion of the PCL and the medial 1/3 point of the tibial tuberosity).||degree||Standard Deviation|Mean
77476|NCT01027780|Primary|Electroencephalography Measurement|Measurement of alpha asymmetry at the F3/4 (frontal) electrode. Left prefrontal activation has been associated with positive affect, and with higher levels of antibody responses and natural killer cell cytotoxicity.|post-treatment (time 2)|Some subject EEG recordings were excluded from analyses due to reading/equipment factors (e.g., poor signal, external noise) or subject factors (e.g., sleepiness, illness). Subjects were also allowed to opt out of the EEG procedures if desired.||Log right-log left alpha power||Standard Error|Mean
77479|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Number of Letters Read Correctly||Standard Deviation|Mean
77480|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Safety Population: all patients who received study treatment||Number of Letters Read Correctly||Standard Deviation|Mean
77481|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Microns||Standard Deviation|Mean
77482|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Safety Population: all patients who received study treatment||Microns||Standard Deviation|Mean
77483|NCT01027650|Primary|Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Number of Letters Read Correctly||Standard Deviation|Mean
77484|NCT01027650|Primary|Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Safety Population: all patients who received study treatment||Number of Letters Read Correctly||Standard Deviation|Mean
77485|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye||Microns||Standard Deviation|Mean
77486|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Safety Population: all patients who received study treatment||Microns||Standard Deviation|Mean
77487|NCT01027598|Secondary|Objective Response Rate (ORR)|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|18 Months|Includes all patients who were evaluated for response||percentage of evaluated participants|||Number
77488|NCT01027598|Secondary|Overall Survival|The length of time, in months, that patients were alive from first date of protocol treatment until death.|18 months|All treated patients||months||95% Confidence Interval|Median
77489|NCT01027598|Primary|Progression-free Survival|The length of time, in months, that patients were alive from first date of protocol treatment until worsening of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|14 months|All treated patients||months||95% Confidence Interval|Median
77490|NCT01027468|Secondary|Systemic Complications After Treatment, Central Retinal Thickness||3 years after initial bevacizumab treatment||||||
77491|NCT01027468|Primary|Vision||3 years after initial intravitreal bevacizumab treatment||||||
77492|NCT01027468|Primary|Vision||3 years after first intravitreal bevacizumab treatment|||logMar||Standard Deviation|Mean
77493|NCT01027195|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|||points on a scale||Standard Deviation|Mean
77494|NCT01027195|Secondary|Harris Hip Score (Outcome Score)|A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|||points on a scale||Standard Deviation|Mean
77495|NCT01027195|Secondary|Length of Stay||day of hospital discharge|||days||Standard Deviation|Mean
77502|NCT01026974|Secondary|Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post dose 2|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Geometric Mean
77503|NCT01026974|Secondary|Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch–up dose of rMenB+OMV NZ in children at 40 months.|1 month post booster / 1 month post dose 1|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
77504|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age.|18 months post vaccine dose 2|Analysis was done on MITT population||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
77505|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40- & 42- months or 60- & 62- months of age are reported.|1 month post vaccine dose two|Analysis was done on the MITT population.||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
77506|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age.|20 months post booster/ Baseline for Naïve|Analysis was done on MITT population.||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
77507|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.|The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch–up dose of rMenB+ OMV NZ in children at 40 months.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
77508|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after primary vaccination/ Baseline for Naïve|Analysis was done on MITT population.||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
77509|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catch-up doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported.|18 months post vaccine dose two|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
77510|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs.|18 months post vaccine dose 2|Analysis was done on the MITT population||Titers||95% Confidence Interval|Geometric Mean
77511|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
77512|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The serum bactericidal antibody response in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age are reported as GMTs.|1 month post vaccine dose two|Analysis was done on MITT population||Titers||95% Confidence Interval|Geometric Mean
77513|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age|The percentage of subjects with hSBA titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported.|1 month post -vaccine dose two|Analysis was done on MITT population||percentages||95% Confidence Interval|Number
77514|NCT01026974|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age.|20 months post booster/ Baseline for Naïve|This analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
77535|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 9|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 9|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 9.||participants|||Number
77515|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine –naïve subjects of the same age and reported as GMTs.|20 months post booster/ Baseline for Naïve|Analysis was done on the MITT population||Titers||95% Confidence Interval|Geometric Mean
77516|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|"The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with 4-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.~Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age for Naive_4042 group."|1 month post booster / 1 month post dose 1 for Naïve|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
77517|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age|The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.|1 month post-booster/ 1 month post-dose 1 for Naïve|Analysis was done on MITT population.||percentages of subjects||95% Confidence Interval|Number
77518|NCT01026974|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.|The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.|Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]|Analysis was done on the Safety population- defined as all subjects who received at least one Men B vaccination and provided post-baseline safety data.||participants|||Number
77519|NCT01026974|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.|"The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after primary vaccination; Baseline for Naïve|Analysis was done on MITT population||percentages of subjects||95% Confidence Interval|Number
77520|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population.||Titers||95% Confidence Interval|Geometric Mean
77521|NCT01026974|Primary|Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.|The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.|28 months after primary vaccination; Baseline for Naïve|Modified Intention-to-treat (MITT) population was defined as enrolled subjects who actually received at least one vaccine dose,and provided at least one evaluable serum sample both before and after baseline.||Titers||95% Confidence Interval|Geometric Mean
77522|NCT01026948|Secondary|Number of Participants Who Were Satisfied With Monitoring at Home|Maternal views were assessed by semi-structured diaries,recording women’s ratings on a 4 point scale (very satisfied, satisfied, slightly disatisfied, very disatisfied)of how well they were coping and their satisfaction with outpatient experience.Women completed diaries at least once every two hours at home.Mean scores were calculated for women’s ratings of coping, comfort satisfaction and location preference. An interpretive approach was utilised for all open responses. Comments made in the free-text spaces of diaries were categorised to contextualise women’s ratings of their experience|6 months|51 women out 70 returned the semistructured diaries. All the diaries were assessed as explained above.||participants|||Number
77523|NCT01026948|Primary|Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.|Outpatient induction is when women recieve medication to induce labour at the hospital, but can then go home for monitoring until labour progresses. When 'standard' Doppler Ultrasound FHR technology is used, women may feel restrained as the Doppler-FHR machine (which is bench-top device) is connected to the transducer which is then mounted on the woman's abdomen and attached by an elastic belt, which is known to be uncomfortable for pregnant woman. The AN 24 device is portable and attaches to the patients abdomen allowing remote fetal monitoring whilst the women are at home.|6 months|70 women were recruited to the study, but 8 women were called back to the unit because of signal loss.||participants|||Number
77524|NCT01026909|Secondary|Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.||StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits|||steps/day||Standard Deviation|Mean
77536|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 2|Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (“Do you ever wake up with an erection”) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).|Month 2|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 2||participants|||Number
77525|NCT01026909|Primary|Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.|"The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are:~Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best.~We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales."|This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.|||units on a scale||Standard Deviation|Mean
77526|NCT01026844|Secondary|Correlate Epidermal Growth Factor Receptor (EGFR) Mutations and EGFR Amplification With Response to Treatment in Patients With Available Tumor Specimens.||2 years|Because so few responses were observed, this exploratory outcome was not analyzed|||||
77527|NCT01026844|Secondary|Objective Tumor Response Rate|Number of Response Evaluation Criteria in Solid Tumors (RECIST) responses divided by number of patients treated. Per RECIST version 1.0 complete response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. The objective tumor response rate is the CR + PR divided by the total number of patients|2 years|||percentage of patients||95% Confidence Interval|Number
77528|NCT01026844|Secondary|Determine the Pharmacokinetic (PK) Parameters of Hydroxychloroquine (HCQ) Plus Erlotinib.|PK parameter tested was dose normalized minimum steady state concentration (Cmin SS) of HCQ in micromolar per gram. Note this outcome was only analyzed for the first 21 patients enrolled, 13 on erlotinib/HCQ and 8 on HCQ arm.|2 years|The patients participating in the randomized portion of the study were analyzed for PK parameters. When the HCQ alone arm of the study was closed, PK measurements were no longer performed||micromolar per gram||Standard Deviation|Mean
77529|NCT01026844|Primary|Describe the Number and Type of Observed Dose Limiting Toxcities|HCQ doses tested included 400mg, 600mg, 800mg, and 1000mg. Dose-limiting toxicities (DLTs) were defined as CTC of grade 2 or higher retinopathy or keratitis, or CTC of grade 3 or higher hematologic, skin, CNS, neuropathic, cardiac, respiratory, gastrointestinal, or renal AEs in the first cycle considered at least possibly related to HCQ. If a DLT was observed, an additional three patients were enrolled at that dose level. The maximum tolerated dose for HCQ in each arm would be defined as one dose level below that at which two or more of 6 patients experienced a DLT, or if no DLTs were observed, the highest tested dose.|2 years|In October 2008, after enrollment of 18 patients (8 on arm A and 10 on arm B), the study was amended to limit enrollment to arm B only (HCQ plus erlotinib) given the increasing preclinical evidence supporting a role for combination therapy (but not HCQ monotherapy) and to help increase overall patient accrual.||participants|||Number
77530|NCT01026831|Other Pre-specified|Baseline IOP|IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).|Baseline|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.||mmHg||95% Confidence Interval|Least Squares Mean
77531|NCT01026831|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)|"IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).~IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12).~Lowering elevated IOP is a treatment goal of glaucoma."|Baseline, Weeks 2, 6, and 12.|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.||mmHg||95% Confidence Interval|Least Squares Mean
77532|NCT01026818|Secondary|Change in Penile Length and Girth|Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.|Randomization (Baseline), Month 9|All randomized participants who received at least 1 dose of study drug and had penile measurements at Baseline and Month 9.||millimeter (mm)||95% Confidence Interval|Least Squares Mean
77533|NCT01026818|Secondary|Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score|EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline EPIC-26 scores measurement at Month 9 and Month 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
77534|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 13.5|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 13.5|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 13.5.||participants|||Number
77537|NCT01026818|Secondary|Change From Baseline in ‘Yes’ Answers to Morning Erections|The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of “yes” responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.|Randomization (Baseline), Month 10.5|All randomized participants who received at least 1 dose of study drug and had morning erection question answered at Baseline and Month 10.5.||"percentage of yes response"||95% Confidence Interval|Least Squares Mean
77538|NCT01026818|Secondary|Change From Baseline in ‘Yes’ Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)|Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEP questions answered at Months 9, 10.5 and 13.5.||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
77539|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 13.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 13.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 13.5.||participants|||Number
77540|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 10.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 10.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 10.5.||participants|||Number
77541|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 9|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 9|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 9.||participants|||Number
77542|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 5.||participants|||Number
77543|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 2|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 2|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 2.||participants|||Number
77544|NCT01026818|Secondary|Residual Erectile Function (REF) at Baseline|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Baseline|All randomized participants who received at least 1 dose of study drug and had REF assessed at baseline.||participants|||Number
77545|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 13.5|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5.||participants|||Number
77546|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 9|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9.||participants|||Number
77547|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 1 at Month 13.5|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5.||participants|||Number
77548|NCT01026818|Secondary|Global Assessment Questions (GAQ) Question 1 at Month 9|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9.||participants|||Number
77557|NCT01026805|Secondary|Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score|a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator(“1” = “poor” and “10” = “excellent”).|2-3 months post treatment|All treating physicians completed a survey questionnaire.||scores on a scale||Full Range|Mean
77549|NCT01026818|Secondary|Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score|The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
77550|NCT01026818|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score|The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
77551|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)|Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
77552|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5.||units on a scale||95% Confidence Interval|Least Squares Mean
77553|NCT01026818|Secondary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 9 and Month 13.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5.||percentage of participants|||Number
77554|NCT01026818|Primary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 10.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5.||percentage of participants|||Number
77555|NCT01026805|Primary|Percentage of Tissue Removed|mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.|immediately post-treatment|||Percentage of tissue removed||Full Range|Mean
77556|NCT01026805|Secondary|Adverse Events|Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study|2-3 months post-treatment|||events|||Number
77567|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 2|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set||Participants|||Number
77568|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 1|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set||Participants|||Number
77569|NCT01026402|Secondary|Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose|Phosphorylation levels of AKT from PRP (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set||Percent change||Full Range|Median
77570|NCT01026402|Secondary|Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose|Phosphorylation levels of 4EBP1 from peripheral blood mononuclear cell (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set||Percent change||Full Range|Median
77571|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) at Steady State|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set||L/h||Standard Deviation|Mean
77572|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) Single Dose|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set||L/h||Standard Deviation|Mean
77573|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State|Fraction dose excreted unchanged in the urine from 0-12 hours after dosing (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK||Percent concentration||Standard Deviation|Mean
77574|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose|Fraction dose excreted unchanged in the urine from 0-12 hours after a single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 12 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK||Percent concentration||Standard Deviation|Mean
77575|NCT01026402|Secondary|Area Under the Curve (AUC) at Steady State|AUC at steady state Continuous dosing - AUCss used Intermittent dosing - Weekly AUC used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
77576|NCT01026402|Secondary|Maximum Concentration (Cmax) at Steady State|Cmax at steady state (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
77577|NCT01026402|Secondary|Area Under the Curve (AUC) Single Dose|Area under the curve following single dose Continuous dosing - AUC parameter used Intermittent dosing - AUC(0-12) used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
77578|NCT01026402|Secondary|Maximum Concentration (Cmax) Single Dose|Maximum concentration following single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
77579|NCT01026402|Secondary|Best Objective Response|Best Objective Response per Response Evaluation Criteria in Solid Tumours Criteria (RECIST) 1.1 for target and non target lesions assessed by CT, MRI or X-ray; Complete Response (CR), Disappearance of all target lesions since baseline; Partial Response (PR), At least a 30 percent decrease in the sum of diameters of target lesions; Progressive Disease (PD), At least a 20 percent increase in the sum of diameters of target lesions and an absolute increase of at least 5mm|Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months|Efficacy analysis set - Patients who received at least 1 dose of AZD2014 and have a baseline tumour assessment||Participants|||Number
77580|NCT01026402|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in >1 patient|Up to 21 days from first multiple dose|Safety Analysis Set - All patients that received at least 1 dose of AZD2014. This includes dosed patients who are not evaluable for dose escalation decision purposes.||Participants|||Number
77581|NCT01026389|Secondary|Sensitivity|sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).|up to one month|Per protocol population||positive segment with MRA|Participants||Number
77582|NCT01026389|Secondary|Specificity|Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).|up to one month|per protocol population||negative segments in MRA|Participants||Number
77583|NCT01026389|Secondary|Intra-patient Accuracy, in Off-site Readings|• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion|up to one month|"Ecah images from each patient were analysed by two external readers, this means that each patient was analyzed twice.~Per protocol population"||percentage of agreement|Participants|Standard Deviation|Mean
77584|NCT01026389|Primary|Intra-patient Accuracy (Percent Agreement), On-site Data|intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.|up to one month|Per protocol population||percentage of agreement||Standard Deviation|Mean
77585|NCT01026324|Secondary|Progression-free Survival||Up to 6 months|||participants|||Number
77586|NCT01026324|Primary|Percentage of Patients Alive (Phase II)|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II|Up to 1 year|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II|||||
77587|NCT01026324|Primary|Recommended Phase-2 Dose of SCH727965|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.|14 days|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.|||||
77588|NCT01026194|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
77589|NCT01026194|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*h / dL||Standard Error|Least Squares Mean
77590|NCT01026194|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
77591|NCT01026194|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||Percent of HbA1c||Standard Error|Least Squares Mean
77592|NCT01026142|Secondary|Duration of Objective Response|Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only patients with an objective response were included in the analysis of duration of objective response.|Tumor Assessment every 9 weeks until week 27, then every 12 weeks thereafter|||Weeks||95% Confidence Interval|Median
77593|NCT01026142|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of patients with a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months.|Tumor Assessment every 9 weeks until week 27, then every 12 weeks thereafter|Data was analyzed for number of responders||Percentage of participants||95% Confidence Interval|Number
77594|NCT01026142|Secondary|Overall Objective Response Rate (ORR)|Overall Objective Response Rate is based upon investigator and Independent Review Facility (IRF) assessments. Objective Response Rate (ORR) was defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. Patients without a post-baseline tumor assessment were considered to be non-responders.|Tumor Assessment every 9 weeks until week 27, then every 12 weeks thereafter|||Percentage of participants|||Number
77595|NCT01026142|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) was defined as time between randomization and date of disease progression based on IRF assessments, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first. Based upon Independent Review Facility (IRF) assessment.|Tumor Assessment every 9 weeks until week 27, then every 12 weeks thereafter|||Weeks||95% Confidence Interval|Median
77596|NCT01026142|Secondary|Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment|Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease.|Tumor Assessment every 9 weeks until week 27, then every 12 weeks thereafter|||Weeks||95% Confidence Interval|Median
77597|NCT01026142|Secondary|Investigator Assessment Progression-Free Survival (PFS)|Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first.|Tumor Assessment every 9 weeks until week 27, then every 12 weeks thereafter|Intent-To-Treat (ITT) Population (By Treatment Randomized); All patients randomized included in the ITT population, regardless of whether they received any study treatment.||Months||95% Confidence Interval|Median
77598|NCT01026142|Secondary|Overall Survival (OS) Based on a 2-year Truncated Analysis|Overall Survival is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year.|From randomization until death from any cause|Intent-To-Treat (ITT) Population (By Treatment Randomized); All patients randomized included in the ITT population, regardless of whether they received any study treatment.||Percentage of participants||95% Confidence Interval|Number
77599|NCT01026142|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. An interim analysis of OS was performed at the time of the analysis of the primary endpoint, Independent Review Facility (IRF)-assessed Progression-Free Survival (PFS), with type 1 error control. The final OS analysis will take place at the end of study when 67% of patients have died (approximately 300 deaths). Analysis methods at this time will be the same as those described for the primary endpoint. Prior to the data analysis cut-off, it will be ensured that all patients who are in survival follow-up have been contacted as recently as possible within the last 3 months to confirm current survival status.|From randomization until death from any cause|Intent-To-Treat (ITT) population (By Treatment Randomized)||Months||95% Confidence Interval|Median
77600|NCT01026142|Primary|Progression Free Survival (Independent Assessment)|Progression Free Survival is defined as the time from randomization to the first documented disease progression, (PD) as determined by IRF using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurs first.|Tumor Assessment every 9 weeks until week 27, then every 12 weeks thereafter|||months||95% Confidence Interval|Median
77601|NCT01026103|Secondary|Incidence of Serosal Tearing||30 days post op|||participants|||Number
77602|NCT01026103|Secondary|Length of Hospital Stay||Date of discharge which averages 3 days|||days||Standard Deviation|Mean
77603|NCT01026103|Secondary|Incidence of Intra-operative Bleeding Requiring Intervention||Day 0 and 1 month|||participants|||Number
77604|NCT01026103|Primary|Proportion of Patients With an Uneventful Creation of a Functional Staple Line||Day 0|||participants|||Number
77605|NCT01026038|Post-Hoc|Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
77606|NCT01026038|Secondary|Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.||Percentage of Participants||95% Confidence Interval|Number
77607|NCT01026038|Secondary|Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.||Percentage of Participants||95% Confidence Interval|Number
77608|NCT01026038|Secondary|Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine|Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.||Geometric mean titers||95% Confidence Interval|Geometric Mean
77682|NCT01024738|Primary|Plaque Index|Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 Days|||Units on a scale||Standard Deviation|Mean
77609|NCT01026038|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Up to 7 days before vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.||Geometric mean titers||95% Confidence Interval|Geometric Mean
77610|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Four to seven days after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
77611|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Up to 7 days before vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
77612|NCT01026038|Primary|Percentage of Participants With Prespecified Systemic Events|Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."||Percentage of Participants|||Number
77613|NCT01026038|Primary|Percentage of Participants With Prespecified Local Reactions|Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."||Percentage of Participants|||Number
77614|NCT01026038|Primary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine|Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
77615|NCT01026012|Primary|Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)|During and 30 minutes after stress test|Subjects whom completed the combined stress test, including imaging||participants|||Number
77616|NCT01025843|Secondary|Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.||µmol/L||Standard Deviation|Mean
77617|NCT01025843|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan|Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.|Baseline and 1 to 3 hours postdose|Results were not analyzed because none showed a > 5% decrease in AIx.|||||
77755|NCT01023568|Secondary|Mean Hemodynamic Response: Heart Rate||measured at 1 minute interval at induction time and from intubation for 10 minutes.|||beats/min||Standard Deviation|Mean
77756|NCT01023568|Secondary|Cormack-Lehane Grade||immediately after intubation|||participants|||Number
77618|NCT01025843|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.||umol.hr/L||Standard Deviation|Mean
77619|NCT01025843|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Up to 24 hours after administration of study drug|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.||Participants|||Number
77620|NCT01025843|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Up to 14 days after administration of last dose of study drug (up to Day 52)|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.||Participants|||Number
77621|NCT01025830|Secondary|Maximum Plasma Concentration of Drug|Maximum concentration of drug in plasma that was attained post dosing|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Intention to treat analysis used including only participants with sufficient plasma samples for analysis. Separate analyses are given for each drug. Results for this kind of study are not combined.||milligram/liter||Standard Deviation|Geometric Mean
77622|NCT01025830|Primary|Area Under the Concentration-Time Curve(AUC)|Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Analyzed population consists only of participants who had sufficient plasma samples for analysis.Intent to treat analysis was used. Separate analyses provided for each drug. Results of such a study are not combined.||hour*milligram/liter||Standard Deviation|Geometric Mean
77623|NCT01025817|Secondary|Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events|Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS||Participants|Participants||Number
77624|NCT01025817|Secondary|Number of Participants With Incidence of Proteinuria Events|Number of participants with Incidence of proteinuria events indicating chronic kidney disease|Baseline and 12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS||Participants|Participants||Number
77625|NCT01025817|Secondary|Number of Participants With Incidence of New Onset of Diabetes Mellitus|Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant, or with a random plasma glucose ≥200 mg dL (11.1 mmol/L) with 2 fasting plasma glucose values ≥126 mg/dL (7 mmol/L)|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.||Participants|Participants||Number
77626|NCT01025817|Secondary|Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy|Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS||Participants|Participants||Number
77627|NCT01025817|Secondary|Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)|Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.||Participants|Participants||Number
77628|NCT01025817|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1|12 Months|Full Analysis Set (FAS) consisted of all patients randomized after transplantation||mL/min/1.73m˄2||Standard Deviation|Mean
77629|NCT01025817|Primary|Number of Participants With Incidence of Composite Efficacy Failure|Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, (3) participant death or(4) loss to follow-up. *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.|12 Months|Full Analysis Set (FAS) consisted of all participants randomized after transplantation||Participants|Participants||Number
77630|NCT01025635|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as ‘responder’. Subjects with an IGA of moderate or severe at the end of treatment were considered as ‘non-responder’. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as ‘non-responders’.|At End of treatment (up to 12 weeks) (LOCF)|||Percentage of participants|||Number
77631|NCT01025635|Secondary|Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||At End of treatment (up to 12 weeks) (LOCF)|||Percentage of Inflammatory lesions||Standard Deviation|Mean
77632|NCT01025635|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||Baseline and End of treatment (up to 12 weeks) (LOCF)|||Inflammatory lesions||Standard Deviation|Mean
77633|NCT01025635|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At End of treatment (up to 12 weeks) (LOCF)|||Percentage of participants|||Number
77634|NCT01025492|Primary|Apolipoprotein A-I Serum Concentration|Comparison of apolipoprotein A-I concentrations after 12 weeks of treatment with either Trilipix or placebo|12 weeks|The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled. Additionally, the study outcome measure/endpoint (Apolipoprotein A-I serum concentration) was not analyzed.|||||
77635|NCT01025336|Primary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
77636|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77637|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77638|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77639|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77640|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77641|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77642|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77643|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77644|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77645|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77646|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.||titer||95% Confidence Interval|Geometric Mean
77647|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77648|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77649|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77650|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77651|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77652|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77653|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77654|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||titer||95% Confidence Interval|Geometric Mean
77655|NCT01025336|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population included all participants enrolled in 6115A1-3018 (NCT01025336) with a valid and determinate assay result who received both vaccinations in either parent study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572). N=number of participants with valid and determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
77656|NCT01025271|Secondary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) to Determine the CSF Penetration and Pharmacokinetic Parameters in This Patient Population (|no analysis completed|5 years||||||
77657|NCT01025271|Primary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis|unable to meet enrollment no data available. Study terminated early|5 years|unable to meet enrollment no data available. Study terminated early|||||
77658|NCT01025232|Secondary|Evaluate the Relationship Between Specific Genetic Polymorphisms Associated With AMD, Disease Characteristics and Processes, and Response to Intravitreal Ranibizumab||1 year|Given lack of clinical benefit of 2.0 mg ranibizumab, as demonstrated in the HARBOR trial [Busbee BG, et al. (2013) Ophthalmology 120(5), 1046-1056], further secondary analyses were suspended.|||||
77659|NCT01025232|Secondary|Assess Number of Ranibizumab Injections in Each of the Two Doses Required Through Month 12||1 year|||number of injection||Standard Deviation|Mean
77660|NCT01025232|Secondary|Evaluate Mean Change in Central Retinal Thickness Over Time Through Month12 as Assessed by All Three OCTs (Stratus, Cirrus, and Spectralis)||1 year|||micrometer||Standard Deviation|Mean
77661|NCT01025232|Secondary|Determine Number of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12 in ETDRS BCVA.||1 year|||participants|||Number
77662|NCT01025232|Secondary|Determine Number of Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12 and Month 12 in ETDRS BCVA||1 year|||participants|||Number
77663|NCT01025232|Secondary|Evaluate the Incidence and Severity of Ocular and Non-ocular Adverse Events (AEs) Through Month 12||1 year|||Incidents|||Number
77664|NCT01025232|Primary|Mean Change From Baseline in ETDRS BCVA at Month 12 (Fixed Interval Dosing Primary Endpoint After 3 Monthly Doses. Variable Interval Dosing Primary Endpoint at 1 Year.)|Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) was used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|1 Year|||ETDRS BCVA Letters||Standard Error|Mean
77665|NCT01025154|Primary|Median Event-Free Survival (EFS)|Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death.|2 years|Two of the fifty-nine participants were not included in the analysis.||Months||Full Range|Median
77757|NCT01023568|Secondary|Mean Hemodynamic Response: Mean Arterial Blood Pressure||measured at 1 minute interval at induction time and from intubation for 10 minutes|||mmHg||Standard Deviation|Mean
77758|NCT01023568|Primary|Time to Successfully Intubate Patient.||from start of intubation to successfully intubated up to 5 minutes|||seconds||Inter-Quartile Range|Median
77666|NCT01025154|Primary|Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery|Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L. Response evaluated within 8 weeks after induction therapy.|8 weeks after Induction therapy (induction cycle 4-6 weeks)|Two of the fifty-nine participants were not evaluable.||participants|||Number
77667|NCT01025076|Primary|Primary Outcome: Change in Body Weight||At 6 months|||kg||Standard Deviation|Mean
77668|NCT01025037|Secondary|Isometric Strength||baseline, post-op months 6, 12, and 24|||newtons (N)||Standard Deviation|Mean
77669|NCT01025037|Primary|Simple Shoulder Test (SST)|"The Simple Shoulder Test (SST): a series of 12 yes or no questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure & Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome."|baseline, post-op months 3, 6, 12, and 24|||units on a scale||Standard Deviation|Mean
77670|NCT01025037|Primary|Adjusted Constant-Murley Score|The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living – sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller & Uhl, 2005).|baseline, post-op months 6, 12, and 24|||units on a scale||Standard Deviation|Mean
77671|NCT01025037|Other Pre-specified|Incidence of Complications, Including Infection|Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert.|All time points|||percentage of participants|||Number
77672|NCT01025037|Secondary|Rotator Cuff Re-tear Evaluation|"Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported.~Two different definitions of a re-tear were used for the analysis.~Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.~Sub-analysis: Full thickness tear one centimeter or greater in length."|Post-op months 6 and 12|Participants were analyzed at 6 and 12 months post-op. 2 participants not analyzed due to exclusion prior to 6 month post op visit.||percentage of participants|||Number
77673|NCT01025037|Primary|American Shoulder and Elbow Score (ASES)|The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, & Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.|baseline, post-op months 3, 6, 12, and 24|||units on a scale||Standard Deviation|Mean
77674|NCT01024972|Secondary|In-hospital Mortality|Number of subjects who expired during hospitalization.|up to 90 days|||participants|||Number
77675|NCT01024972|Secondary|Liver Toxicity|Number of subjects who developed liver toxicity as evidenced by Liver Function Test elevation greater than 5 times the upper limit of normal.|7 days|||participants|||Number
77676|NCT01024972|Primary|Hyponatremia|Number of subjects who developed hyponatremia (sNa ≤132mmol/L)|Seven days|||participants|||Number
77677|NCT01024959|Primary|Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)|The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score >=25 was positive, PCA3 Score <25 was negative|At the time of biopsy|A total of n=466 subjects have valid and reportable PCA3 Scores and disease status (determined by biopsy result), and who were 50 years of age or older.||participants|||Number
77678|NCT01024946|Primary|To Determine the Rate of Clinical Benefit (i.e. Rate of Complete or Partial Response Plus Stable Disease) at 16 Weeks for Patients With Malignant Mesothelioma Treated With Everolimus as Second or Third Line Therapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|16 weeks|||participants|||Number
77679|NCT01024855|Primary|Number of Eyes With No Change in Corneal Staining|Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.|Change from baseline after 1, 2, 4 and 6+ hours of wear|per protocol||eyes|||Number
77680|NCT01024751|Secondary|Slit Lamp Findings|Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.|Over all visits for 1 month|Greater than grade 2 for all dispensed eyes with non-missing scores||eyes|Participants||Number
77681|NCT01024751|Primary|Comfort-related Symptoms/Complaints|Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.|At dispensing visit and each follow-up visit at week 2 and week 4.|Summaries included all eligible, dispensed participants, with participants summarized under the study products received.||Units on a scale|Participants|Standard Deviation|Mean
77683|NCT01024608|Secondary|Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period|"Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities).~The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
77684|NCT01024608|Secondary|Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of ‘emotional’ utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.|Day 0 (Baseline), Day 15|The RQLQ population, subset of ITT population, included only those participants over the age of 18 years (fluent in English) with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
77685|NCT01024608|Secondary|Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The iTNSS (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
77686|NCT01024608|Primary|Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping).~The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
77687|NCT01024465|Primary|Total Weight Loss|Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.|baseline to 180 days|Subjects with a weight recorded at 6 months||kg||Standard Deviation|Mean
77688|NCT01024335|Primary|Retention|Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.|retention over 8 weeks.|||participants|||Number
77689|NCT01024335|Primary|Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .|The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.|3x/week during 8 weeks of the trial or study participation|||units on a scale||Standard Deviation|Mean
77690|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.||units on a scale||Inter-Quartile Range|Median
77691|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.||units on a scale||Inter-Quartile Range|Median
77759|NCT01023516|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation.|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Participants|||Number
77692|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|6 week|A total of 54 participants returned for follow-up at 6 weeks. 3 participants did not complete the WOMAC in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.||units on a scale||Inter-Quartile Range|Median
77693|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|6 week|54 participants returned for follow-up at 6 weeks. A total of 5 participants did not complete the Harris Hip Score instrument in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.||units on a scale||Inter-Quartile Range|Median
77694|NCT01024309|Secondary|Anteversion Angle|Anteversion angle is a radiographic measure of implant position. 35 degrees of anteversion is optimal. 25-45 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 35 degrees indicate better placement.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.||degrees||Inter-Quartile Range|Median
77695|NCT01024309|Secondary|Abduction Angle|Abduction angle is a radiographic measure of implant position. 40 degrees of abduction is optimal. 30-50 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 40 degrees indicate better placement.|6 wk|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.||degrees||Inter-Quartile Range|Median
77696|NCT01024309|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC)|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.||units on a scale||Inter-Quartile Range|Median
77697|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.||units on a scale||Inter-Quartile Range|Median
77698|NCT01024309|Primary|Number of Days for Discontinue Assistive Devices|The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. Lower number of days indicate better outcomes.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.||days||Inter-Quartile Range|Median
77699|NCT01024244|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||beats per minute (bpm)||Standard Deviation|Mean
77810|NCT01023256|Secondary|Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8|Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.|Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8|All treated patients||joints||Standard Deviation|Mean
77700|NCT01024244|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes per 30 days|||Number
77701|NCT01024244|Secondary|Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.||nanograms per milliliter times hour||Standard Deviation|Mean
77702|NCT01024244|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and the sparse sampling approach.||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
77703|NCT01024244|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|No participants had data analyzed due to insufficient sample size.||milligrams (mg)||Standard Deviation|Mean
77704|NCT01024244|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77705|NCT01024244|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77706|NCT01024244|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77707|NCT01024244|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks, Baseline through 16 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.||percentage of participants|||Number
77708|NCT01024244|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
77830|NCT01023022|Secondary|Time and Cost Savings for Patients||Baseline to max. 12 months||||||
77709|NCT01024244|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of participants|||Number
77710|NCT01024244|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||millimoles per liter (mmol/L)||Standard Deviation|Mean
77711|NCT01024244|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||kilograms (kg)||Standard Deviation|Mean
77712|NCT01024244|Secondary|Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||hypoglycemic episodes|||Number
77713|NCT01024244|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.||mm Hg||Standard Deviation|Mean
77714|NCT01024244|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.||units on a scale||Standard Deviation|Mean
77715|NCT01024244|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.||millimoles per liter (mmoL/L)||Standard Deviation|Mean
77716|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
77717|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.||percentage of beta cell function (%B)||Standard Deviation|Mean
77718|NCT01024244|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.||milliseconds (ms)||Standard Deviation|Mean
77719|NCT01024244|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
77720|NCT01024036|Secondary|Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline|SF-36 is a questionnaire and PCS is a part of subscle assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life.|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment|Intent-to-treat (ITT) population: all randomized participants||Days||95% Confidence Interval|Median
77721|NCT01024036|Secondary|Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline|The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from “not at all” (0) to “very much” (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes.|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment|Intent-to-treat (ITT) population: all randomized participants||Days||95% Confidence Interval|Median
77722|NCT01024036|Secondary|Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman’s Disease Symptom Scale (MCD-SS) Score From Baseline|A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe).|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment|Intent-to-treat (ITT) population: all randomized participants||Days||Full Range|Median
77723|NCT01024036|Secondary|1-year Survival Rate||1 year|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
77724|NCT01024036|Secondary|Percentage of Participants Who Discontinued Corticosteroids|Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1).|From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment|All randomized participants who were dependent on corticosteroids at baseline||Percentage of participants|||Number
77725|NCT01024036|Secondary|Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)||Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 post-baseline hemoglobin evaluation.||Percentage of participants|||Number
77726|NCT01024036|Secondary|Percentage of Participants Who Achieved >= 15 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)||Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 postbaseline hemoglobin evaluation.||Percentage of participants|||Number
77727|NCT01024036|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman’s disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC).|From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment, whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants||Days||95% Confidence Interval|Median
77728|NCT01024036|Secondary|Median Duration of Tumor Response - by Independent Radiology Review|Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment|All randomized participants who achieved tumor response during blinded treatment period as per independent review||Days||Full Range|Median
77729|NCT01024036|Secondary|Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review|Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment|Response-evaluable Population: included participants who received at least 1 administration of siltuximab/placebo and had at least 1 post-baseline radiologic disease evaluation||Percentage of participants|||Number
77831|NCT01023022|Secondary|Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)||Baseline to max. 12 months||||||
77730|NCT01024036|Secondary|Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review|Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. Symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.|From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment|All randomized participants who achieved durable tumor and symptomatic response during blinded treatment period as per independent review||Days||Full Range|Median
77731|NCT01024036|Primary|Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review|Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from the study, or up to 48 weeks after the last participant started study medication, whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
77732|NCT01023841|Primary|Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score|The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
77733|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.||Intensity units||Standard Deviation|Mean
77734|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.||mm^2||Standard Deviation|Mean
77735|NCT01023841|Secondary|Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent-to-treat population included all randomized participants.||mm||Standard Deviation|Mean
77736|NCT01023841|Primary|Percentage of Participants With Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|5 Months|Safety population included all randomized participants who received treatment.||Percentage of participants|||Number
77737|NCT01023815|Secondary|Change in Serum Creatinine|Serum creatinine (a blood measurement) is an important indicator of renal health because it is an easily-measured by-product of muscle metabolism. Measuring serum creatinine is a simple test and it is the most commonly used indicator of renal function.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||mg/dL||Standard Deviation|Mean
77738|NCT01023815|Secondary|Change in Estimated Creatine Clearance|At each visit, estimated creatinine clearance was measured in the local laboratory to analyze the evolution of the renal function. The following indirect measures of renal function were computed: estimated creatinine clearance according to Cockcroft and Gault formula and MDRD formula.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||mL/min||Standard Deviation|Mean
77739|NCT01023815|Secondary|Number of Participants With Graft and Patient Survival After Randomization|"Graft Survival, calculated from the date of transplantation to the date of irreversible graft failure signified by return to long‐term retransplantation or the date of the last follow‐up during the period when the transplant was still functioning or to the date of death.~Patient survival, calculated from the date of transplantation to the date of death or the date of the last follow‐up."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||Participants|||Number
77740|NCT01023815|Secondary|Biopsy Proven Acute Rejection (BPAR) Rate Between Randomization and Month 12|"Occurrence of BPAR (after randomization) between arm B (steroid withdrawal group) and arm c (standard twice-a-day group).~BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III according to Banff 1997 grading with 2007 update."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||Participants|||Number
77832|NCT01023022|Secondary|Clinician Ease of Use of, and Satisfaction With, the Medtronic CareLink® Monitor and Website (Including Clinician General Preference, if Any, for Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)||Baseline to max. 12 months||||||
77741|NCT01023815|Secondary|Changes in the Estimated Glomerular Filtration Rate (eGFR) Between Randomization (Month 3) and Month 12|eGFR by Nankivell, in terms of descriptive statistics and change vs randomization visit - to compare the changes in the estimated GFR (Nankivell) between randomization and Month 12 in the steroid withdrawal group (Group B) to the change observed in the standard twice-a-day group (Group C), for non-inferiority|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).||mL/min||Standard Deviation|Mean
77742|NCT01023815|Primary|Treatment Failure Rate|Occurrence or not of treatment failure in each patient. Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection (a biopsy graded IA, IB, IIA, IIB or III according to Banff ’97 grading with 2007 update), graft loss, death or lost to follow-up occurring after randomization (V5) and within M12 (V9).|Between randomization (Month 3) and Month 12|ITT population: all randomized pts who received at least one dose of study drug after Visit 5 & have at least one post-baseline assessment of the primary efficacy variable. Change in study design stopped the randomization into Group A, due to overall slow enrollment rate & shifted all relative objectives to exploratory, due to small sample size.||Participants|||Number
77743|NCT01023776|Secondary|Mean Difference Between Cycle Time and Detection Threshold|The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.|day 10 post vaccine 1|per protocol||cycles||95% Confidence Interval|Mean
77744|NCT01023776|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|28 days post vaccine 1 and 28 days vaccine 2|per protocol||participants|||Number
77745|NCT01023724|Primary|Anterior Chamber Inflammation (Flare)|Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.|Day 14 of treatment|||photon count per msec (pc/ms)||Standard Deviation|Mean
77746|NCT01023711|Secondary|Assessment of the Reactogenicity Events Post Vaccination.|Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination|7 days|Subjects who completed the 7 day diary card||participants|||Number
77747|NCT01023711|Primary|Determination of Immune Response to Vaccination.|Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination|28 days|All subjects who completed Day 28 visit post vaccination were analyzed.||participants|||Number
77748|NCT01023672|Primary|Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|"The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day.~The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded.~In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal."|baseline, 12 weeks|Per Protocol; 3 subjects did not complete the study (2 had worsening disease, and 1 died) and did not complete this test.||minutes||Inter-Quartile Range|Median
77749|NCT01023659|Primary|Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician|Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed|End of Treatment|Number of participants who were met all study criteria||participants|||Number
77750|NCT01023659|Primary|7-day Point Prevalence of Abstinence|"7-day point prevalence of abstinence was assessed by the question Have you had a cigarette, even a puff, in the past 7 days?"|6-month|Number of eligible participants who either received bupropion + motivational emails, varenicline + motivational emails or motivational emails alone (because they either did not attend a physician visit or their physician decided not to prescribe them bupropion or varenicline)||percentage of participants||95% Confidence Interval|Number
77751|NCT01023581|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. Includes only data collected on or after baseline and within 1 day after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.||mg/dL||Standard Error|Least Squares Mean
77752|NCT01023581|Secondary|Change From Baseline in HbA1c Over Time|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.~Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate."|Baseline and Weeks 4, 8, 12, 16, and 20.|The full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. The analysis includes only data collected on or after baseline and within 7 days after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
77753|NCT01023581|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26.|Full analysis set (patients who took at least 1 dose of study medication) where baseline and at least 1 postbaseline assessment were available. Analysis includes only data collected on or after baseline and within 7 days after last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
77754|NCT01023568|Secondary|Number of Participants Who Experienced Desaturation|Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after|measured at 1 minute interval at induction time and from intubation for 10 minutes.|||participants|||Number
77760|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).Questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
77761|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Deviation|Mean
77762|NCT01023516|Secondary|Endurance Shuttle Walk Test - End Value|Assessed at vist 6 -( last on treatment clinic visit)|Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Error|Least Squares Mean
77763|NCT01023516|Secondary|Endurance Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Deviation|Mean
77764|NCT01023516|Secondary|Incremental Shuttle Walk Test - End Value||Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Error|Least Squares Mean
77765|NCT01023516|Secondary|Incremental Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||seconds||Standard Deviation|Mean
77766|NCT01023516|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||inhalations||Standard Error|Least Squares Mean
77767|NCT01023516|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status). End of treatment week 12|End of treatment week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
77768|NCT01023516|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Deviation|Mean
77769|NCT01023516|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
77770|NCT01023516|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Deviation|Mean
77771|NCT01023516|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
77858|NCT01022307|Primary|Performance on Trail-making Test, Part B|z-score based on response time, regressed for age and computer use|Single session generally several years after TBI depending on time of recruitment of subjects.|z-score||z-score||Standard Deviation|Mean
77772|NCT01023516|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Deviation|Mean
77773|NCT01023516|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77774|NCT01023516|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77775|NCT01023516|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak expiratory flow (PEF)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
77776|NCT01023516|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Deviation|Mean
77777|NCT01023516|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77778|NCT01023516|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77779|NCT01023516|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77780|NCT01023516|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77781|NCT01023516|Secondary|End-value Post-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Error|Least Squares Mean
77782|NCT01023516|Secondary|Baseline Post-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Deviation|Mean
77783|NCT01023516|Secondary|End-value Pre-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Error|Least Squares Mean
77859|NCT01022242|Primary|TAM2|The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.|At 12 weeks after surgery|FAS population||Degrees||Full Range|Median
77784|NCT01023516|Secondary|Baseline Pre-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/sec||Standard Deviation|Mean
77785|NCT01023516|Secondary|End-value Post-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77786|NCT01023516|Secondary|Baseline Post-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77787|NCT01023516|Secondary|End-value Pre-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77788|NCT01023516|Secondary|Baseline Pre-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77789|NCT01023516|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77790|NCT01023516|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77791|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77792|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77793|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77794|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77795|NCT01023516|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
77796|NCT01023516|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
77797|NCT01023308|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group|Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.|12, 24 and 48 weeks|Full Analysis Set||score on a scale||95% Confidence Interval|Least Squares Mean
77798|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group|"The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set||score on a scale||95% Confidence Interval|Least Squares Mean
77799|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group|"Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set||score on a scale||95% Confidence Interval|Least Squares Mean
77800|NCT01023308|Secondary|Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||months||95% Confidence Interval|Median
77801|NCT01023308|Secondary|Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||duration of response in months||95% Confidence Interval|Median
77802|NCT01023308|Secondary|Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||time to response in months||95% Confidence Interval|Median
77803|NCT01023308|Secondary|Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.|Best overall response based on mEBMT criteria per investigator assessment|45 months|||% participants with response|||Number
77804|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|survival time in months|45 months|FAS||months||95% Confidence Interval|Median
77805|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|Number of OS events|45 months|||Number of OS events|||Number
77806|NCT01023308|Primary|Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|Full Analysis Set||months||95% Confidence Interval|Median
77807|NCT01023308|Primary|Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|||number of events|||Number
77808|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 8|At week 8, MRI data were not available for 6 placebo patients, 5 MOR103 0.3 mg/kg patients, 1 MOR103 1.0 mg/kg patient, and 2 MOR103 1.5 mg/kg patients.||units on a scale||Standard Deviation|Mean
77809|NCT01023256|Secondary|Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8|Patient-reported outcomes included patient’s self-assessment of pain (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best).|Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8|All treated patients||units on a scale||Standard Deviation|Mean
78013|NCT01020123|Secondary|QTcF; Electorcardiagram Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 258 in CSR)||msec||Standard Deviation|Mean
77811|NCT01023256|Secondary|Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4|The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.|Week 4 (1 week after last MOR103 dose)|All participants were included in ACR response calculations. Patients lacking data required for calculation of an ACR response were considered as not having an ACR response. 1 patient in the MOR103 0.3 mg/kg group, 1 patient in the MOR103 1.0 mg/kg group, and 5 patients in the pooled placebo group had missing data for ACR calculations.||percentage of participants|||Number
77812|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity)|Change from baseline to week 8 (5 weeks after last MOR103 dose)|All treated patients||units on a scale||Standard Deviation|Mean
77813|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 4 (1 week after last MOR103 dose)|At week 4, MRI data were not available for 5 placebo patients, 2 MOR103 0.3 mg/kg patients, 2 MOR103 1.0 mg/kg patients, and 1 MOR103 1.5 mg/kg patient.||units on a scale||Standard Deviation|Mean
77814|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).|Change from baseline to week 4 (1 week after last MOR103 dose)|All treated patients||units on a scale||Standard Deviation|Mean
77815|NCT01023256|Primary|Percentages of Patients With Treatment-emergent or Serious Adverse Events|Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of >5 % (>1 patient) in any treatment group, please see the adverse events listing.|From the first dose through the 16-week visit|All patients who received treatment.||percentage of participants|||Number
77816|NCT01023217|Secondary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 104 from randomization||||||
77817|NCT01023217|Secondary|Normalization of ALT Level||at week 52 and at week 104 from randomization||||||
77818|NCT01023217|Secondary|Genotypic Resistance to ADV or ETV||at week 52 and at week 104 from randomization||||||
77819|NCT01023217|Secondary|Reduction in Serum HBV DNA Levels||at week 52 and at week 104 from randomization||||||
77820|NCT01023217|Primary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 52 from randomization|||participants|||Number
77821|NCT01023178|Primary|Estradiol|Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.|end of study (up to 2 years)|||pg/mL||Standard Error|Mean
77822|NCT01023074|Secondary|SCAN-A: Competing Words Test|The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance.|Test administered during one session|||units on a scale||Standard Deviation|Mean
77823|NCT01023074|Secondary|Neural Magnetic Resonance Imaging (MRI)|Gray matter volume|Results were recorded during one scanning session|Data reported for 47 study participants who underwent MRI||cubic cm||Standard Deviation|Mean
77824|NCT01023074|Primary|Electrophysiological Auditory Test|"auditory P300 amplitude in response to rare 1000 Hz tones"|Recordings were conducted during one session|||microvolts||Standard Deviation|Mean
77825|NCT01023035|Secondary|Percentage of Participants Who Discontinued Treatment|Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification [LLQ] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).|From Study Day 1 up to Study Treatment Week 48|All Treated Participants, defined as all participants who were treated with any study medication.||percentage of participants||95% Confidence Interval|Number
77826|NCT01023035|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24|At Follow-up Week 24|The primary efficacy analysis was performed on all participants who were randomized to either the RBV Dose Reduction Arm or the EPO Use Arm for anemia management (i.e. the Full Analysis Set of patients requiring anemia management [FAS, n=500]).||percentage of participants|||Number
77827|NCT01023022|Secondary|Handling of Unscheduled Activities (for Example, Symptoms and Events)|"Investigators were asked to classify reasons for unscheduled visits by marking all applicable answers. Answer: 1) patient symptoms 2) adequate therapy/shock 3) appearance of already known arrythmias 4) appearance of new arrythmias 5) need for reprogramming 6) in house Follow-up 7) device alert 8) inadequate therapy/shock 9) worsening of pump function 10) malfunction of the device 11) other"|Baseline to max. 12 months|The 68 patients of total population (176) were analyzed as this number of pt. had experienced unscheduled visit during the study.||% of unscheduled visits due to reasons|unscheduled visits||Number
77828|NCT01023022|Secondary|Efficiency Through Increased Flexibility and Per Procedure Time||Baseline to max. 12 months||||||
77829|NCT01023022|Secondary|Time and Costs Savings for Physicians||Baseline to max. 12 months||||||
77833|NCT01023022|Secondary|Patient Ease of Use of, and Satisfaction With the Medtronic CareLink® Monitor (Including Percentage of Patients Who Prefer Follow up With Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)|"Participants were asked questions to which they could have respond multiple answers. 1) Which form of device follow up do you prefer? Answers: Monitor from home and in hospital follow up is necessary; Follow up only in hospital; No preference, and 2) How would you judge the user friendliness of the monitor in total? Answers: Very easy; Easy; Difficult; Missing Data, and 3) How did the monitor changed your daily life? did you felt more or less safe? Answers: Much more safe; Safe; No influence; Unsafe; Missing data"|Baseline to max. 12 months|Number of patients who provided responses for these questions at the end of the Study.||percentage of patients|||Number
77834|NCT01023022|Primary|Comparison of Remote Device Check and In-clinic Device Assessment|"Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"|Baseline to max. 12 months|Number of Investigators who provided responded for these questions at the end of evaluation.||percentage of Investigators|||Number
77835|NCT01022502|Secondary|Patients Preferred Ointment Type.|At the end of the trial, the patients were asked which ointment they preferred.|Week 8|Total number of participants completing the 8 week period with study intervention.||participants|||Number
77836|NCT01022502|Secondary|Patients' Rating of the Overall Improvement at Week 8|At week 8, patients rated an overall response to treatment (separately for each side of the body), taking into account both the extent and the degree of the disease, compared with the pretreatment condition, on a 6-point scale (0=worse,1=poor, 2=fair, 3=good, 4=excellent, 5=cleared). A score of 4 or higher represents a better outcome.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention and who reported excellent or cleared at week 8 were used for analysis.||participants|||Number
77837|NCT01022502|Primary|Percentage Improvement Compared to Baseline in the Target Plaque.|The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared percent of improvement related to baseline between the two lesions and before treatment with those after treatment.||percent change of target plaque||95% Confidence Interval|Mean
77838|NCT01022502|Primary|Clearing Percentage of Target Plaque Area|The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared clearing percent of target plaque between the two lesions and before treatment with those after treatment.||percentage of the target area||95% Confidence Interval|Mean
77839|NCT01022502|Primary|Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.|The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared PSI scores between the two lesions and before treatment with those after treatment.||units on a scale||95% Confidence Interval|Mean
77840|NCT01022996|Secondary|Progression Free Survival (PFS) by Kaplan-Meier Estimate|Progression-free survival (PFS) was defined as the time from the first date of treatment to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. An event for PFS was defined as a documented disease progression or death due to any cause or start of a new antineoplastic therapy, whichever occurred first. Cycle = 28 days.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||95% Confidence Interval|Median
77841|NCT01022996|Secondary|Duration of Disease Control|The duration of overall response (CR/PR) was applied only to patients whose best overall response was CR or PR. Duration of overall response was calculated from the date of the first documented response of CR or PR to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||Standard Deviation|Mean
77842|NCT01022996|Secondary|Disease Control Rate (DCR)|The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Percentage of participants||95% Confidence Interval|Number
77860|NCT01022203|Secondary|Emotion Regulation|Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.||units on a scale||Standard Deviation|Mean
77843|NCT01022996|Secondary|Duration of Overall Response (DoR)|The duration of overall response was calculated from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. This only applies to patients whose best overall response is CR or PR.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||Standard Deviation|Mean
77844|NCT01022996|Secondary|Time to Overall Response (TTR) Per Kaplan-Meier Estimate|Time to overall response was defined as the time from the first date of treatment to the date of first documented response of CR or PR. Time to overall response is applied to patients whose best overall response is CR or PR. Patients who drop-out or did not have a response (CR or PR) will be treated as censored at the date of last adequate tumor assessment.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||Days||95% Confidence Interval|Median
77845|NCT01022996|Primary|Overall Response Rate (ORR) Based on the Assessments by Investigator|ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal & extranodal lesions: Radiological regression to normal size of all lymph nodes & nodal masses & complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal & extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal & extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented & one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.|at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.||percentage of participants|||Number
77846|NCT01022762|Secondary|Change in Body Weight||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation||kg||Standard Error|Least Squares Mean
77847|NCT01022762|Secondary|Cholesterol|"The number of participants having a change in cholesterol from normal to abnormal. Abnormal means a value of blood cholesterol is out of the normal range."|Week 0, week 16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s)||participants|||Number
77848|NCT01022762|Secondary|Number of All Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product.|Weeks 0-16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s). One participant was randomised into repaglinide group, but was dispensed gliclazide from the very beginning of the study due to the investigator's negligence. This participant continued the gliclazide treatment until the end of the study.||episodes|||Number
77849|NCT01022762|Secondary|Change in AUC0-180 of Plasma Glucose Concentration of IVGTT||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.||min*mmol/L||Standard Deviation|Mean
77850|NCT01022762|Secondary|Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.||min*pmol/L||Standard Deviation|Mean
77851|NCT01022762|Secondary|Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
77852|NCT01022762|Secondary|Change in Fasting Serum Free Fatty Acid (FFA) From Baseline||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
77853|NCT01022762|Secondary|Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%||Week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||percentage of participants|||Number
77854|NCT01022762|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal|A standard meal contains 100g carbohydrate|Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
77855|NCT01022762|Secondary|Change in Fasting Plasma Glucose||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||mmol/L||Standard Error|Least Squares Mean
77856|NCT01022762|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
77857|NCT01022398|Primary|Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy||6 months||||||
77861|NCT01022203|Secondary|Relationship Functioning|Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.||units on a scale||Standard Deviation|Mean
77862|NCT01022203|Primary|Psychological Functioning|Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education.||units on a scale||Standard Deviation|Mean
77863|NCT01022190|Primary|Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively.|"Percentage of participants in which Heterotopic Ossification of the hip was assessed, according to the Brooker grade.~Brooker-0): No ossification. Brooker-1): Isolated bone islands, Brooker-2): Bone spurs from the pelvis or proximal femur;space between opposing surface ≥ 1 cm, Brooker-3): Bone spurs from the pelvis or proximal femur;space between opposing surface < 1 cm, Brooker-4): Apparent bony ankylosis. Brooker score 1 to 4 are considered 'heterotopic ossification'."|6 months postoperatively|Patients who underwent total hip arthroplasty and received afterwards Etoricoxib medication.||percentage of participants|||Number
77864|NCT01022112|Secondary|Safety and Tolerability||14 weeks||||||
77865|NCT01022112|Secondary|Fasting Blood Glucose, Body Weight||12 weeks||||||
77866|NCT01022112|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||12 weeks|Full analysis set, last observation carried forward||percent HbA1C||Standard Error|Least Squares Mean
77867|NCT01022073|Primary|Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher the value, the worse the outcome.|The change score of UPDRS Part III from baseline to 9 years post surgery|Patients had completed the 9 year follow-up post surgery||units on a scale||Standard Deviation|Mean
77868|NCT01021878|Secondary|Total Ultrafiltration|Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.|3 months|||millilitre||95% Confidence Interval|Mean
77869|NCT01021878|Secondary|Glycated Hemoglobin|"Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.~Glycated hemoglobin was measured by high-performance liquid chromatography."|3 months|||percentage of haemoglobin||95% Confidence Interval|Mean
77870|NCT01021878|Secondary|Serum Insulin|Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense.|3 months|||log(mmol/L)||95% Confidence Interval|Mean
77871|NCT01021878|Secondary|Oral Fasting Serum Glucose|"Serum glucose measured in oral fasting but not peritoneal fasting.~For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at < 0.05."|3 months|||mg/dl||95% Confidence Interval|Mean
77872|NCT01021878|Primary|Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor|"Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows:~(fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405"|3 months|||IR score||95% Confidence Interval|Mean
77873|NCT01021852|Primary|Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|APaT population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.||percentage of participants|||Number
77874|NCT01021852|Primary|Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.||percentage of participants|||Number
77875|NCT01021852|Secondary|Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment|LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R&K scoring. LS mean LPS was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization LPS efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
77876|NCT01021852|Secondary|Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment|WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. LS mean WASO was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization WASO efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
77877|NCT01021852|Primary|Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment|SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization SE efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||percentage of time in bed spent sleeping||Standard Error|Least Squares Mean
77878|NCT01021813|Other Pre-specified|Number of Participants Who Reported Suicidal Ideation and/or Behavior On Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidal ideation and/or behavior that occurred on study was also assessed using the C-SSRS, a rater-administered questionnaire used to prospectively assess suicidal ideation and suicidal behavior. C-SSRS assessment was based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale.~Suicidal ideation and/or behaviors identified on the C-SSRS may not have been considered an adverse event, based on the investigator's judgment."|From the first day of study treatment through study follow-up (up to 14 months)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||participants|||Number
77879|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase|The sTSOm was defined as the average over time of daily e-diary values for a participant's report of the time he or she required to fall asleep (measured in minutes). Weekly sTSOm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSOm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.||minutes||95% Confidence Interval|Least Squares Mean
77880|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase|The sTSTm was defined as the average over time of daily e-diary values for a participant's report of the total amount of time spent asleep before waking for the day (measured in minutes). Weekly sTSTm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSTm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.||minutes||95% Confidence Interval|Least Squares Mean
77889|NCT01021813|Primary|Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase|Sleep paralysis was defined as the inability to perform voluntary muscle movements during sleep. Sleep paralysis adverse events included sleep-onset paralysis (paralysis as one is falling asleep).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment||percentage of participants|||Number
77890|NCT01021813|Primary|Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase|Cataplexy is defined as a sudden loss of muscle tone while awake which prevents voluntary movement.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
77881|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective time to sleep onset (sTSO) as recorded in the participant’s morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTSO value (in minutes) on any of the first 3 nights of the Run-out Phase occurring after one year of treatment (Month 13) was greater than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.||percentage of participants|||Number
77882|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective total sleep time (sTST) as recorded in the participant’s morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTST value (in minutes) on any of the 3 nights of the Run-out Phase (first 3 nights of the Discontinuation Phase) occurring after one year of treatment (Month 13) was less than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.||percentage of participants|||Number
77883|NCT01021813|Secondary|Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ)|"Withdrawal effects assessed using Tyrer WSQ, which evaluated the presence/absence and severity of withdrawal symptoms with 20 items (i.e. sensitivity to noise, light, smell, touch, feeling unreal, etc). The Tyrer WSQ was completed as part of the evening e-diary prior to dosing on the Month 12 visit and on the 3 consecutive evenings of the DB Run-out Phase (first 3 nights of DB Discontinuation Phase). Responses rated 0 (No), 1 (Yes-moderate), or 2 (Yes-severe); range from 0 (no withdrawal) to 40 (severe withdrawal).~A participant was defined to have a withdrawal symptom if an item during any of the 3 DB Run-out days had emerged for the first time, or had worsened compared to the measurement obtained at the end of the Treatment phase (Month 12). For single night analysis, a patient was defined to have withdrawal effects if the number of withdrawal symptoms (emergent or worsening) was ≥3. For across night analysis, withdrawal was defined as a total of ≥3 symptoms across the 3 nights."|Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out])|Participants in the APaT population who completed the entire DB Treatment Phase, had at least one measurement at the end of the DB Treatment Phase (Month 12), had taken at least one dose of Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.||percentage of participants|||Number
77884|NCT01021813|Primary|Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase|The pre-specified terms which were suggestive of abuse potential on this study included depersonalization (feeling of watching oneself act, while having no control over a situation), derealization (alteration in the perception or experience of the external world so that it seems unreal), dissociation (includes a wide array of experiences from mild detachment from immediate surroundings to more severe detachment from physical and emotional experience), euphoric mood (exaggerated feeling of physical and emotional well-being and optimism not consonant with apparent stimuli or events), mania (state of abnormally elevated or irritable mood, arousal, and/or energy levels), hallucination (perception in the absence of a stimulus which has qualities of real perception), and potential study medication misuse.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
77885|NCT01021813|Primary|Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase|Perceptual distortions associated with transitions between wakefulness and sleep were termed as hypnagogic (occurring during the onset of sleep) or hypnopompic (occurring during onset of wakefulness) hallucinations.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
77886|NCT01021813|Primary|Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase|Suicidal ideation included suicidal plans, suicidal tendency, death wishes, life weariness, and suicidal intention. Suicidal behaviors included suicide attempts, suicide gesture, and self-injurious behaviour. Suicidal ideation and/or behavior was reported as an AE and considered an ECI.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
77887|NCT01021813|Primary|Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase|Falls were adjudicated (to establish whether a fall event was due to cataplexy).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
77888|NCT01021813|Primary|Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase|Complex sleep-related behaviors were reported as ECIs and were characterized by patients engaging in specific activities while asleep (e.g., eating, drinking, preparing meals, making phone calls, having sex, driving, and sleep walking).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.||percentage of participants|||Number
77891|NCT01021761|Primary|Aqueous PGE2 Inhibition|A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.|Day 4 of treatment|Protocol specified 126 subjects to be enrolled and analysis was performed per protocol.||pg/ml||Standard Deviation|Mean
77892|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Breakthrough Fungal Infection|Plasma level of itraconazole was defined as the sum of IC and HIC. A breakthrough fungal infection was defined as any fungal infection that was diagnosed more than (>) 3 days on or during therapy or within 7 days after completion of therapy. Blood cultures were assessed to identify fungus.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.||ng/mL||Standard Deviation|Mean
77893|NCT01021683|Secondary|Percentage of Participants With Baseline Fungal Infection|Blood cultures (a laboratory test on a sample of blood) were assessed to identify fungus. Percentage of participants with presence or absence of fungus before starting the study drug were calculated.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Percentage of Participants|||Number
77894|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment|Plasma level of itraconazole was defined as the sum of IC and HIC. The OSR was defined based on satisfaction of the following criteria: (1) participants if treated for baseline fungal infection, there was either eradication (removal of fungus in culture), or presumed eradication; no evidence in culture but appeared to be treated clinically, (2) absence of breakthrough fungal infection during the treatment and for 7 days after completing the treatment, (3) survival for 7 days after completing the treatment, (4) absence of early withdrawal due to adverse events or lack of efficacy, and (5) defervescence. The presence and absence of OS was reported.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.||ng/mL||Standard Deviation|Mean
77895|NCT01021683|Secondary|Percentage of Participants With Defervescence by Plasma Level of Itraconazole|Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment. Plasma level of itraconazole was defined as the sum of IC and HIC.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'n' signifies participants who were evaluable for this measure at given time points.||Percentage of Participants|||Number
77896|NCT01021683|Secondary|Absolute Neutrophil Count (ANC)|The mean values for ANC based on blood tests performed on Day 0 (before starting the study treatment) constitute a Baseline measure for ANC.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Cells/mm^3||Standard Deviation|Mean
77897|NCT01021683|Secondary|Duration of Neutropenia|The duration of neutropenia was reported. Neutropenia was defined as neutrophil count less than or equal to (<=) 500 cells per cubic millimeter (cells/mm^3), or neutrophil count <=1000 cells/mm^3 and anticipated to decrease to <=500 cells/mm^3 within several days.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Days||Standard Deviation|Mean
77898|NCT01021683|Secondary|Mean Time to Defervescence in Participants Who Received the Study Treatment|The mean time to defervescence was reported in participants who received the study treatment. Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Standard Deviation|Mean
77899|NCT01021683|Secondary|Percentage of Participants With Deferevescence After Administration of Study Treatment|Defervescence was defined as fall of the body temperature below 38.0 degree Celsius (C) at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Percentage of Participants|||Number
77900|NCT01021683|Primary|Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment|Percentage of participants who achieved more than or equal to 1000 ng/ml level after administration of study treatment were reported. Plasma level of itraconazole was defined as the sum of itraconazole concentration (IC) and hydroxyitraconazole concentration (HIC).|Day 5|The intent-to-treat (ITT) population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.||Percentage of Participants||95% Confidence Interval|Number
77901|NCT01021618|Secondary|Myocardial Perfusion Image Quality|Single photon emission computed tomography myocardial perfusion acquisition and image processing was performed in accordance with American Society of Nuclear Cardiology guidelines. All images were interpreted by consensus read of three investigators blinded to stress test protocol and results. Overall perfusion and gated image quality were described as excellent (no artifacts interfering with myocardial perfusion interpretation), good, fair, or poor (artifact requiring reprocessing or repeat imaging of the patient to allow for diagnostic interpretation).|0 hours|Note that images were unavailable in one vasodilator-exercise patient because of urgent catheterization after stress test without imaging and one exercise-vasodilator patient for technical reasons.||participants|||Number
77902|NCT01021618|Primary|"Number of Participants With Major Adverse Events or Side Effects Graded Severe on Symptom Questionnaire"|"Number of participants with any side effect (flushing, shortness of breath, headache, chest discomfort, dizziness, nausea, or abdominal pain) requiring specific treatment or graded as severe by the patient; or any death, myocardial infarction, or unplanned hospitalization. Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis."|24 hours|Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.||participants|||Number
77903|NCT01020526|Primary|Change From Baseline in Pain Numeric Rating Scale by Week|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.|Baseline, Weeks 3, 8, 16, 24 and Last Visit.|This population will include all participants who have received at least one dose of study medication.||Number||Standard Deviation|Mean
77904|NCT01020474|Secondary|Proportion of Patient Global Impression Change (PGIC) at Week 15|Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.||percentage of participants|||Number
77905|NCT01020474|Secondary|Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score.||percentage of participants|||Number
77906|NCT01020474|Secondary|Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score.||percentage of participants|||Number
77907|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score.||Units on a scale||Standard Error|Least Squares Mean
77908|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)|Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
77909|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)|Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
77910|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Sleep Quality Diary Score|Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score.||Units on a scale||Standard Error|Least Squares Mean
77911|NCT01020474|Primary|Change From Baseline to Week 15 in Mean Pain Diary Score|The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 (“no pain”) and 10 (“worst possible pain”).|Week 15|The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
77912|NCT01020448|Secondary|Safety, Assessed Through the Collection of Adverse Events (AEs)||For the duration of the study (up to month 6)|||participants|||Number
77913|NCT01020448|Secondary|PSA Level||At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.||μg/L||Full Range|Median
77914|NCT01020448|Secondary|Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)||At month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.||percentage of participants|||Number
77915|NCT01020448|Secondary|TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)|"TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000~A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'"|At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.||participants|||Number
77916|NCT01020448|Secondary|PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000~Non-assessable = Associated PSA mRNA <7500 copies/mL~≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL~<35 = PCA-3 mRNA above BLQ and less than 35~≥35 = PCA-3 mRNA greater or equal to 35"|At month 1 and 3 post-treatment|Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population.||participants|||Number
77917|NCT01020448|Primary|PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000~Non-assessable = Associated PSA mRNA <7500 copies/mL~≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL~<35 = PCA-3 mRNA above BLQ and less than 35~≥35 = PCA-3 mRNA greater or equal to 35"|At month 6 post-treatment|Number of participants analyzed were 298 as one participant was admitted to an asylum and was withdrawn before month 1 visit was scheduled. No post-baseline assessment was available for this patient.||participants|||Number
77918|NCT01021423|Secondary|Participants With a Tumor Response|"Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.||participants|||Number
77919|NCT01021423|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.|up to 2 years|Study terminated prematurely. Analysis not conducted.||months||95% Confidence Interval|Median
77920|NCT01021423|Secondary|Time to Progression|"Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.||months||95% Confidence Interval|Median
77921|NCT01021423|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|"Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to 9 months|Safety population of participants who received at least one dose of study drug||participants|||Number
77922|NCT01021423|Secondary|Overall Survival|"Overall survival was defined as the time from randomization to death from any cause.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.||months||95% Confidence Interval|Median
77923|NCT01021423|Primary|Progression-free Survival (PFS)|"PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.||months||95% Confidence Interval|Median
77924|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77925|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
77926|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
77927|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
77928|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
77929|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||participants|||Number
77930|NCT01021332|Secondary|Number of OAB-q Responders Based on Health-related Quality of Life: Total Score|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||percentage of participants|||Number
77931|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77932|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77933|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77934|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77935|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77936|NCT01021332|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77937|NCT01021332|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
77938|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used||units on a scale||Standard Deviation|Mean
77939|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
77940|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
77941|NCT01021332|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
77942|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.||pads||Standard Deviation|Mean
77943|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.||nocturia episodes||Standard Deviation|Mean
77944|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.||incontinence episodes||Standard Deviation|Mean
77945|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.||urgency incontinence episodes||Standard Deviation|Mean
77946|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with at least 1 urgency episode at baseline. LOCF imputation was used.||urgency episodes||Standard Deviation|Mean
77947|NCT01021332|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||ml||Standard Deviation|Mean
77948|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||ml||Standard Deviation|Mean
77949|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||micturitions||Standard Deviation|Mean
77950|NCT01021332|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and up to 52 weeks of FDC treatment|Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.||units on a scale||Standard Deviation|Mean
77951|NCT01021332|Primary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline micturition episode.||ml/s||Standard Deviation|Mean
77952|NCT01021332|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseine and one post-baseline micturition episode.||ml/s||Standard Deviation|Mean
77953|NCT01021332|Primary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline PVR volume measured.||ml||Standard Deviation|Mean
77954|NCT01021332|Primary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).|From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)|Safety analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period||participants|||Number
77955|NCT01021306|Secondary|Bothersomeness of Symptoms|Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)|2 months|||units on a scale||95% Confidence Interval|Mean
77956|NCT01021306|Secondary|Oral Health Impact Profile (OHIP-14)|The OHIP-14 contains 2 questions about each of 7 dimensions (14 items), indicating how often the participant had experienced each difficulty in the previous month; possible responses range from 0 (never) to 4 (very often). The OHIP score was obtained by summing the 14 ratings.|2 months|||units on a scale||95% Confidence Interval|Mean
77957|NCT01021306|Primary|Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)|The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).|2 months|||units on a scale||95% Confidence Interval|Mean
77958|NCT01021215|Secondary|Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels|Proportion of cases with a post-treatment increase in urinary PGE-M levels by comparing those treated with Zileuton and Celecoxib combined therapy compared to those treated with Zileuton alone. Pre/postchange in levels (Increase) derived from baseline level to Day 6 +/- 1 day. Differences in baseline levels between 2 treatment arms were examined using the Wilcoxon rank-sum test.|Baseline to Day 6|Analysis includes only number of participants in each treatment arm with post-treatment increase in urinary PGE-M levels as measured from baseline.||proportion of participants|||Number
77959|NCT01021215|Primary|Median Urinary LTE4 Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary LTE4 levels measured in each treatment arm compared using paired t-test should the data conform to the normality assumption or one-sample Wilcoxon rank-sum test. LTE4 levels reported as median with full range (pg/mg creatinine) for Pre treatment versus Post treatment LTE4 levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and day 6|Seventy-seven subjects completed the entire study, three withdrew for personal reasons. Seven of those participants were excluded from analysis as non-compliant (study medications were undetectable).||pg/mg creatinine||Full Range|Median
77960|NCT01021215|Primary|Median Urinary PGE-M Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary PGE-M levels measured in each treatment arm. PGE-M levels reported as median with full range (ng/mg creatinine) for Pre treatment versus Post treatment PGE-M levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and Day 6|Seventy-seven subjects completed the entire study with seven of those excluded from analysis as non-compliant (study medications were undetectable). Urine of two participants contained interfering substances thus were excluded from PGE-M related analysis.||ng/mg creatinine||Full Range|Median
77961|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Colchicine(fasted)-could not be determined for Subject 25. Colchicine(high-fat meal)-could not be determined for Subjects 22,25, and 28. Colchicine/Probenecid(fasted)-could not be determined for Subject 25.||pg-hr/mL||Standard Deviation|Mean
77962|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|||pg-hr/mL||Standard Deviation|Mean
77963|NCT01021020|Primary|Maximal Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|||pg/mL||Standard Deviation|Mean
77964|NCT01021007|Primary|Plaque Index (Quigley-Hein Score)|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||Units on a scale||Standard Deviation|Mean
77965|NCT01021007|Primary|EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale|0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 & 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.|6 weeks|||bleeding sites||Standard Deviation|Mean
77966|NCT01021007|Primary|Gingival Index|1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding|6 weeks|||Units on a scale||Standard Deviation|Mean
77967|NCT01020981|Secondary|PTSD Symptoms|"The PCL is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The PCL-M is a military version and questions refer to a stressful military experience. Total possible scores range from 17 to 85. Higher scores indicate more symptoms of PTSD and a cut-off score of 50 is used for indicating a probable diagnosis of combat-related PTSD."|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|86% of MI NG soldiers who completed surveys returned a complete PCL scale and 87% of IN NG soldiers who completed surveys returned a complete PCL scale.||units on PCL scale||Standard Deviation|Mean
77968|NCT01020981|Secondary|Depressive Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|Data were analyzed for those with complete outcome data. Thus, 1 participant in Michigan Army National Guard and 1 participant in Indiana Army National Guard are not included in these results.||units on a BDI-II scale||Standard Deviation|Mean
77969|NCT01020981|Primary|Feasibility-response Rate|Response rate of Soldiers to a mailed survey.|Survey was fielded to Michigan National Guard Service Members on three occasions, March 2011, April 2011, and May 2011. The survey was also fielded to Indiana National Guard Service Members on September 2011, October 2011, and November 2011.|"8 or 5% of surveys to Michigan NG Soldiers were not deliverable. 32 (21%) of Indiana NG soldier surveys were not deliverable.~66 of 142 delivered surveys to MI soldiers were returned for a response rate of 46%. 60 of 118 deliverable surveys to Indiana NG Soldiers were returned for a response rate of 51%."||% of Soldiers returning mailed survey|||Number
77970|NCT01020903|Primary|Post-operative Nausea and Vomiting|Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.|1 year|"Records for this study are no longer available as they were destroyed in Hurricane Sandy in 10/2012- we do not have any information to use to update the records. The PI for this study is no longer with the institution and no contact information is available. Since we cannot verify the # of participants analyzed, the numbers were changed to 0."|||||
77971|NCT01020877|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.||ng*h/mL||Standard Deviation|Mean
77972|NCT01020877|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.||ng*h/mL||Standard Deviation|Mean
77973|NCT01020877|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.||ng/mL||Standard Deviation|Mean
77974|NCT01020838|Secondary|Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans|Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans.|90-110 minutes post injection (PET image acquisition)|||Standardized Uptake Value Ratio (SUVR)||Standard Deviation|Mean
77975|NCT01020838|Secondary|Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.|Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity.|90-110 minutes post injection (PET image acquisition)|Sensitivity and Specificity of the subject level Composite SUVR with three different SOTs.||percentage of subjects|||Number
77984|NCT01020799|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline|HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
78014|NCT01020123|Secondary|Weight, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 244 in CSR)||kg||Standard Deviation|Mean
77976|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of β-amyloid according to CERAD Criteria (SOT 3).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification according to CERAD Criteria (SOT 3)."||percentage of subjects||95% Confidence Interval|Number
77977|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral neuritic β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining and immunohistochemistry (SOT 2)."||percentage of subjects||95% Confidence Interval|Number
77978|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining (SOT 1).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining (SOT 1)."||percentage of subjects||95% Confidence Interval|Number
77979|NCT01020838|Primary|Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens|"The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as “normal” or “abnormal” depending on the presence or absence of regional tracer uptake in the respective region. “Normal” therefore meant absence of β-amyloid and “abnormal” presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was β-amyloid present. Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|All participants included in the Interim Analysis Set were included in this analysis.||percentage of regions|||Number
77980|NCT01020812|Secondary|Median Progression Free Survival|Time to progression free survival is defined as the time from randomization until either death or progression of disease. The median survival was calculated using a Kaplan Meier algorithm.|18 months|||months||95% Confidence Interval|Median
77981|NCT01020812|Secondary|To Determine the Overall Survival of TACE and SBRT at 18 Months|Overall survival is defined as the time from the start of treatment until death from any cause.|18 months|All patients who completed treatment||probability|||Number
77982|NCT01020812|Secondary|To Determine the Progression-free Survival of TACE and SBRT at 18 Months|Progression free survival is defined as the time from the start of treatment until the first progression or death. Progression will be defined as either local progression, disease occurring elsewhere in the liver, extrahepatic progression or clinical deterioration attributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.|18 months|All patients who completed the treatment||survival probability at 18 months|||Number
77983|NCT01020812|Primary|Freedom From Local Progression of TACE and SBRT at 12 Months|Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.|12 months|All patients who completed treatment||proportion of participants||95% Confidence Interval|Number
78007|NCT01020123|Secondary|ALT; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 206 in CSR)||IU/L||Standard Deviation|Mean
77985|NCT01020799|Secondary|Clinical Global Impression - Severity (CGI-S) Score Change From Baseline|CGI-S assesses global illness severity, i.e. the patient’s current clinical state, on a continuous scale from 1 (“Normal, not ill”) to 7 (“Among the most extremely ill patients”). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
77986|NCT01020799|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.|HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
77987|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Remission|Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4|||Participants|||Number
77988|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Response|Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4|||Participants|||Number
77989|NCT01020799|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.|MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4|||scores on a scale||Standard Error|Least Squares Mean
77990|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period|"Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants||95% Confidence Interval|Number
77991|NCT01020786|Secondary|Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period|"Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants||95% Confidence Interval|Number
77992|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period|"Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed.||percentage of participants||95% Confidence Interval|Number
77993|NCT01020786|Secondary|Overall Survival (OS) During the Maintenance Therapy Period|OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact.|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed; 56 participants and 38 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint, PFS, and final endpoint, respectively.||months||95% Confidence Interval|Median
78008|NCT01020123|Secondary|Creatinine; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 211 in CSR)||IU/L||Standard Deviation|Mean
78009|NCT01020123|Secondary|Potassium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 214 in CSR)||mEq/L||Standard Deviation|Mean
77994|NCT01020786|Secondary|Progression Free Survival (PFS) During the Maintenance Therapy Period|"Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)|Analysis set: Maintenance-treated participants who received maintenance therapy with pemetrexed; 20 and 12 participants were censored at time of primary endpoint (18 months) and final endpoint. They received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD at cut-off.||months||95% Confidence Interval|Median
77995|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants|||Number
77996|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.||percentage of participants||95% Confidence Interval|Number
77997|NCT01020786|Secondary|Overall Survival (OS) During the Induction and Maintenance Therapy Periods|OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact.|Enrollment to the date of death from any cause (up to 30.8 months)|Full analysis set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 79 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint (EP) of PFS. There were 48 participants censored at the final endpoint data cut-off.||months||95% Confidence Interval|Median
77998|NCT01020786|Primary|Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods|"PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 31 participants were censored as they received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD.||months||95% Confidence Interval|Median
77999|NCT01020773|Primary|Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality||13 months|||participants|||Number
78000|NCT01020747|Primary|The Primary Activity Variable Was the Recurrence of Recurrent Respiratory Papillomatosis (RRP) in Bevacizumab Treated and the Un-treated Vocal Fold in the Same Patient During and at the End of the 6-month Treatment Period.|Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.|6 months|All subjects were analyzed.||total percentage change||Standard Deviation|Mean
78001|NCT01020305|Primary|Reduction in Serum PSA|Proportion of subjects with > 50% drop in serum PSA as compared to baseline, assessed at 16 weeks|12 weeks treatment, with primary outcome assessed at 16 weeks|||participants|||Number
78002|NCT01020123|Secondary|EC50 to Characterise the PD Properties of AZD1656.|The value is model based. The value is independent treatment given.|at 4 month|||nmol/L||Standard Error|Mean
78003|NCT01020123|Secondary|CL/F to Characterise the PK Properties of AZD1656.|The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.|at 4 month|||L/h||Standard Error|Mean
78004|NCT01020123|Secondary|Bilirubin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 209 in CSR)||mg/dL||Standard Deviation|Mean
78005|NCT01020123|Secondary|Alkaline Phosphatase; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 208 in CSR)||IU/L||Standard Deviation|Mean
78006|NCT01020123|Secondary|AST; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 207 in CSR)||IU/L||Standard Deviation|Mean
78016|NCT01020123|Secondary|Diastolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 240 in CSR)||mmHg||Standard Deviation|Mean
78017|NCT01020123|Secondary|Systolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 237 in CSR)||mmHg||Standard Deviation|Mean
78018|NCT01020123|Secondary|C-reactive Protein: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 234 in CSR)||ratio||95% Confidence Interval|Geometric Mean
78019|NCT01020123|Secondary|Triglycerides: Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 226 in CSR)||mg/dL||Standard Deviation|Mean
78020|NCT01020123|Secondary|Total Cholesterol: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 232 in CSR)||ratio||95% Confidence Interval|Geometric Mean
78021|NCT01020123|Secondary|HDL-C: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 230 in CSR)||ratio||95% Confidence Interval|Geometric Mean
78022|NCT01020123|Secondary|LDL-C: Mean Ratio|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR)||ratio||95% Confidence Interval|Geometric Mean
78023|NCT01020123|Secondary|HbA1c ≤ 6.5|Number of Responders ≤ 6.5, FAS Prior to Rescue|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR).||Participants|||Number
78024|NCT01020123|Secondary|HbA1c ≤ 7|Number of responders ≤ 7, FAS prior to rescue.|baseline to 4 month|The population is FAS prior to rescue, using the observed cases (see table 35 in CSR).||Participants|||Number
78025|NCT01020123|Secondary|OGTT/Pro-insulin/Insulin|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 154 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||Ratio||95% Confidence Interval|Geometric Mean
78026|NCT01020123|Secondary|OGTT/C-peptide|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 150 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||ratio||95% Confidence Interval|Geometric Mean
78027|NCT01020123|Secondary|OGTT/Insulin|The Relative Change in AUC FAS Prior to Rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 146 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||ratio||95% Confidence Interval|Geometric Mean
78028|NCT01020123|Secondary|OGTT/Plasma Glucose|The relative change in AUC|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 142 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol||ratio||95% Confidence Interval|Geometric Mean
78029|NCT01020123|Secondary|SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 31 in CSR)||mmol/L||95% Confidence Interval|Mean
78030|NCT01020123|Secondary|FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 29 in CSR)||mmol/L||95% Confidence Interval|Mean
78031|NCT01020123|Primary|HbA1c: Change From Baseline to 4 Month|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue|Baseline to 4th Month|The population is FAS prior to rescue, using the LOCF values (see table 27 in CSR)||Percentage||95% Confidence Interval|Mean
78032|NCT01020019|Primary|21 Days of Consecutive Abstinence as Measured by the Time-line Followback.||reported daily for 12 weeks/ or study participation|||participants|||Number
78033|NCT01020006|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0|First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).|||participants|||Number
78034|NCT01019980|Secondary|The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever||2 hours||||||
78035|NCT01019980|Secondary|Safety of Diclofenac Potassium Therapy in the Study Period||6 hours||||||
78036|NCT01019980|Secondary|Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours||6 hours||||||
78037|NCT01019980|Secondary|Time to Reach a Reduction of Temperature as 0.5 and 1 °C||2 hours||||||
78038|NCT01019980|Primary|The Reduction of Temperature||2 hours||||||
78039|NCT01019928|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)|Pre-entry to follow-up|||Participants|||Number
78040|NCT01019928|Secondary|Body Temperature|Oral Body Temperature at 1.5 hours post dose|1.5 hours post dose|||degrees Celsius||Standard Deviation|Mean
78041|NCT01019928|Secondary|QTcF|QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose|1.5 hours post dose|||ms||Standard Deviation|Mean
78042|NCT01019928|Secondary|Pulse|Supine Pulse at 1.5 hours post dose|1.5 hours post dose|||beats/min||Standard Deviation|Mean
78048|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose|||mA||Full Range|Geometric Mean
78049|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose|||mA||Full Range|Geometric Mean
78050|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose|||mA||Full Range|Geometric Mean
78051|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose|||ml||Full Range|Geometric Mean
78052|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose|||ml||Full Range|Geometric Mean
78053|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose|||ml||Full Range|Geometric Mean
78054|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose|||seconds||Full Range|Geometric Mean
78055|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose|||seconds||Full Range|Geometric Mean
78056|NCT01019928|Primary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose|||seconds||Full Range|Geometric Mean
78057|NCT01019707|Primary|Heart Rate|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented.|Timepoints post MA infusion|||BPM|Participants|Standard Deviation|Mean
78058|NCT01019707|Primary|Diastolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented.|Timepoints post MA infusion|||mm Hg|Participants|Standard Deviation|Mean
78059|NCT01019707|Primary|Systolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented.|Timepoints post MA infusion|||mm Hg|Participants|Standard Deviation|Mean
78060|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization||48 weeks|Treated Set is defined as all patients who were randomized and received study drug||participants|||Number
78061|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations||48 weeks|Treated Set is defined as all patients who were randomized and received study drug||participants|||Number
78062|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
78063|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
78064|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
78065|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
78066|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Error|Least Squares Mean
78067|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||number of puffs||Standard Deviation|Mean
78068|NCT01019694|Secondary|Change From Baseline in FVC at Week 48|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78069|NCT01019694|Secondary|Change From Baseline in FVC at Week 24|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78070|NCT01019694|Secondary|Change From Baseline in FVC at Week 12|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78071|NCT01019694|Secondary|Change From Baseline in FVC at Day 1|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78072|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 48|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78073|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 24|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78074|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 12|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78075|NCT01019694|Secondary|Change From Baseline in FEV1 at Day 1|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug||liters||Standard Error|Least Squares Mean
78076|NCT01019694|Secondary|Physician's Global Evaluation at Week 48|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78380|NCT01017237|Primary|Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|Per protocol||percentage of patients|||Number
78077|NCT01019694|Secondary|Physician's Global Evaluation at Week 36|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78078|NCT01019694|Secondary|Physician's Global Evaluation at Week 24|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78079|NCT01019694|Secondary|Physician's Global Evaluation at Week 12|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78080|NCT01019694|Secondary|Physician's Global Evaluation at Week 3|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78081|NCT01019694|Secondary|Physician's Global Evaluation at Week 0|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||units on a scale||Standard Deviation|Mean
78082|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78083|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78084|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78085|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78086|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78087|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||units on a scale||Standard Deviation|Mean
78088|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78089|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78090|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78091|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78092|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78093|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug||units on a scale||Standard Deviation|Mean
78094|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78381|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery|Lack of recall of picture shown indicates presence of amnesia|Day of Surgery prior to discharge|per protocol||percentage of patients|||Number
78095|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78096|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78097|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78098|NCT01019694|Primary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug||unit on a scale||Standard Error|Least Squares Mean
78099|NCT01019486|Secondary|Myocardial Perfusion Index|Myocardial perfusion indices radionuclide stress and rest images and were obtained from 6 regions within the mid ventricular LV short axis slice. Each was corrected for decay and standardized to a 30 mCi administered dose for each part of a two day study.|1 month|||percentage of Ratio Stress/ rest counts||Standard Deviation|Mean
78100|NCT01019486|Secondary|Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.|Regional coronary blood flow reserve (CFR) in a target artery (defined on MPI study) compared to flow in a less diseased atherosclerotic vessel following vasodilator response to intravenously administered regadenoson.|within 6 months|Only 3 individuals met the prescribed perfusion defect on MPI study to proceed to the CFR measurement arm of the study. Therefore numbers were too small for statistical comparison and only mean value and standard deviation of the flow ratio(CFR measurements) are reported..||CFR ratio||Standard Deviation|Mean
78101|NCT01019486|Primary|Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.|Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.|1 month|"Determine the MBF obtained from cardiac MRI from 6 regions of the mid-ventricular LV myocardium and a ratio between stress/rest myocardial blood flow ratio. Differences between group were compared using a unpaired t test analyzed for: control(Con) vs T1DM low risk; Con. vs T1DM High Risk; and T1DM low vs high risk."||percentage of StressMBF/ Rest MBF||Standard Deviation|Mean
78102|NCT01019369|Secondary|Average Minutes Spent Getting Ready for and Giving the Injection|In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.|0-12 months||||||
78103|NCT01019369|Secondary|Scaled Satisfaction Score|This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.|6, 12 months||||||
78104|NCT01019369|Secondary|Prevalence of Participants With Persistent Skin Changes|The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)|12 months||||||
78105|NCT01019369|Secondary|Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available|The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA|6, 12 months||||||
78106|NCT01019369|Secondary|Number of Participants Continuing DMPA|The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.|3, 9, 12 months||||||
78107|NCT01019369|Primary|Number of Participants Continuing DMPA at 6 Months|The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA|6 months|"Data was analyzed with the assumption that participants who were lost to follow-up had discontinued DMPA use."||participants|||Number
78108|NCT01019317|Primary|Participants With a Complete Response|Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.|Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)|Of participants enrolled, 147 participants received treatment and were evaluable.||Participants|||Number
78109|NCT01019135|Secondary|Smoking|Current smoking status|6 months|Participants with available data for current smoking status. Reported values in the table represent number of participants who were current smokers.||Participants|||Number
78110|NCT01019135|Secondary|Medication Adherence|The 4-item Morisky Medication Adherence Scale was used, which is scored as yes = 0, no = 1, such that a higher score indicates higher medication adherence. Scores range from 0 to 4, with patients scoring 2 or above considered adherent.|6 months|Participants with available data for medication adherence||Scores on a scale||Standard Deviation|Mean
78111|NCT01019135|Secondary|Diet|"The Diet Habit Survey was used to assess diet. It is an inexpensive, reliable, and valid instrument for rapid assessment of eating habits and diet composition. Its 9 questions are related to the consumption of cholesterol, saturated fat, complex carbohydrate (including fiber), and salt.~Greater scores indicate better diets, both for the total score and for each area. The total score indicates the level of fat in the diet (with scores equal to or greater than 236 corresponding to a low-fat diet 20% or less). Scores can begin at 56 and have no upper range."|6 months|Participants with available data for diet||Scores on a scale||Standard Deviation|Mean
86393|NCT00943592|Primary|Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
78112|NCT01019135|Secondary|Self-reported Exercise|"The Godin Leisure-time Exercise Questionnaire will be administered in the pre and post-test surveys. It is a brief and reliable instrument to assess usual leisure-time physical activity behaviour during a one-week period. For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Part two of the questionnaire calculates the frequency of weekly leisure-time activities pursued. Total weekly leisure activity is calculated by summing the products of the separate components. Scores begin at zero, with higher scores indicating greater physical activity. For example, scores equal to or greater than 20 are indicative of someone who is active. There is no max score."|6 months|Participants with available data for self-reported exercise||Scores on a scale||Standard Deviation|Mean
78113|NCT01019135|Secondary|Exercise|Mean daily steps as measured by a pedometer over 7 days|6 months|Participants with available data for exercise||Daily steps||Standard Deviation|Mean
78114|NCT01019135|Secondary|Exercise Capacity|Exercise capacity as measured by VO2peak on a graded stress test.|6 months|Participants with available data for exercise capacity||mL/(kg·min)||Standard Deviation|Mean
78115|NCT01019135|Primary|CR Program Adherence||6 months|Participants with available data for adherence||percentage of sessions attended||Standard Deviation|Mean
78116|NCT01018992|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Week 6|Intent to Treat||participants|||Number
78117|NCT01018992|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.||Score on a scale||Standard Deviation|Mean
78118|NCT01018992|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured has having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6|Intent to treat analysis was performed with missing subjects considered to be non-responders.||participants|||Number
78119|NCT01018992|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.||Score on a scale||Standard Deviation|Mean
78120|NCT01018979|Secondary|Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion|||cells/μL||Standard Deviation|Mean
78121|NCT01018979|Secondary|Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||mL/kg||Standard Deviation|Mean
78122|NCT01018979|Secondary|Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||mL/kg||Standard Deviation|Mean
78123|NCT01018979|Secondary|Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||mL/ hr/kg||Standard Deviation|Mean
78124|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr*ng/mL||Standard Deviation|Mean
78125|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr*ng/mL||Standard Deviation|Mean
78126|NCT01018979|Secondary|Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||1/hr||Standard Deviation|Mean
78127|NCT01018979|Secondary|Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr||Standard Deviation|Mean
78128|NCT01018979|Secondary|Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||hr||Standard Deviation|Mean
78129|NCT01018979|Secondary|Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion|||fold||Standard Deviation|Mean
78130|NCT01018979|Secondary|Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.||ng/mL||Standard Deviation|Mean
78131|NCT01018979|Primary|Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).|Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.|1 week|"In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure.~In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure."||participants|||Number
78132|NCT01018953|Secondary|Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels||At 8 timepoints up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
78133|NCT01018953|Secondary|Minimum Concentration (Cmin) BIM 23A760 Plasma Levels||At 9 timepoints up to 1 week after 24th administration in week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
78134|NCT01018953|Secondary|Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)||Up to week 26|Both ITT (Intent-To-Treat) and safety populations were the same analysis group. Treatment emergent adverse events (TEAE) reported by 2 or more patients (safety population) by primary system organ class.||Participants|||Number
78135|NCT01018953|Secondary|Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
78136|NCT01018953|Secondary|Change in the Quality of Life (QoL) Assessment||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
78137|NCT01018953|Secondary|Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)||Up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
78138|NCT01018953|Primary|Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale|Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)|Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.|||||
78139|NCT01018862|Secondary|Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo|change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
78140|NCT01018862|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
78141|NCT01018862|Secondary|Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
78142|NCT01018862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
78143|NCT01018810|Secondary|Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks|Measures anti-LY2525263 antibody as positive or negative. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||participants|||Number
78144|NCT01018810|Secondary|Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks|Area under the curve of serum drug concentration, including absolute bioavailability. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and in each treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||nanograms per milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
78214|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.||pads||Standard Error|Least Squares Mean
78145|NCT01018810|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks|A 14-item questionnaire with anxiety and depression subscales; 21 maximum score. Scores of 11+ on either subscale (significant case of psychological morbidity); 8-10 (borderline); 0-7 (normal). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
78146|NCT01018810|Secondary|Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
78147|NCT01018810|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks|10-item, validated questionnaire covers 6 domains. Responses range from 0 (not at all) to 3 (very much); totals range from 0 to 30 (more impairment). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
78148|NCT01018810|Secondary|Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks|A scale measures patient perception of psoriatic condition with a continuous range of 0 (good) to 5 (severe). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
78149|NCT01018810|Secondary|Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks|A global estimate of pain caused by joint disease on arising made by the subject by placing a vertical mark or tick on a 100-mm VAS from not present to worse, range from 0 to 100mm. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||millimeters (mm)||Standard Deviation|Mean
78150|NCT01018810|Secondary|Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks|The rPGA rates the subject’s psoriasis relative to baseline as 1 (100% clearing), 2 (excellent; 75%-99% clearing), 3 (good; 50%-74% clearing), 4 (fair; 25%-49% clearing), 5 (poor; 0%-24% clearing), or 6 (worsening). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||units on a scale||Standard Deviation|Mean
78151|NCT01018810|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24|PASI combines body-surface assessments and severity of desquamation, erythema, and plaque induration/infiltration. Overall score:0(no psoriasis) to 72(severe disease). Percent(%) improvement=(baseline PASI-observed PASI)/baseline PASI*100. Study BDAD was terminated after enrolling only 8 patients. Least Squares (LS) Mean Values were adjusted for time, treatment, and baseline. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||percentage of units on a scale||95% Confidence Interval|Least Squares Mean
78152|NCT01018810|Primary|Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12|PASI combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema, and plaque induration/infiltration. Overall score: 0 (no psoriasis) to 72 (severe disease). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||percentage of participants|||Number
78153|NCT01018732|Secondary|Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination|Local and systemic reactions were solicited to assess safety and tolerability of vaccination|Up to Day 7|||participants|||Number
78154|NCT01018732|Secondary|Percentage of Subjects With hSBA Seroresponse After Booster Vaccination|For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set||Percentage of participants||95% Confidence Interval|Number
78155|NCT01018732|Secondary|Geometric Mean Ratio After Booster Vaccination|Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1|Day 8 and Day 29 (at 5 Years After Primary Vaccination)|full analysis set||Geometric mean ratio||95% Confidence Interval|Mean
78318|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 15|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 3 (Cycle 1, Day 15)|No participants were analyzed.|||||
78156|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set||Percentage of participants||95% Confidence Interval|Number
78157|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set||Percentage of participants||95% Confidence Interval|Number
78158|NCT01018732|Secondary|Geometric Mean Titer at 5 Years After Primary Vaccination|Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set||Titer||95% Confidence Interval|Geometric Mean
78159|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination|Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set||Percentage of participants||95% Confidence Interval|Number
78160|NCT01018732|Primary|Geometric Mean Titer After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set||Titer||95% Confidence Interval|Geometric Mean
78161|NCT01018732|Primary|Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination|Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination)|Full analysis set (all subjects who had no major protocol violation as defined prior to database lock).||Percentage of participants||95% Confidence Interval|Number
78162|NCT01018680|Other Pre-specified|Percentage of Participants With a Change of Better, Worse, or No Change in Health Outcomes as Measured by Resource Utilization (REU) up to 10 Weeks|"REU captures information regarding the participant’s work status and/or health care utilization. Investigators gather information from medical records, psychiatric history, and direct questioning of the participant and his or her family to complete the questionnaire. Responses to each item, comparing baseline to endpoint, are characterized as Better, Same, or Worse. Better: an increase in time spent working/volunteering/holding a job, decrease in number of health care visits; Same: no change in time spent working/volunteering/holding a job, no change in number of health care visits; Worse: decrease in time spent working/volunteering/holding a job, increase in number of health care visits."|Up to 10 weeks|Intent-to-treat (ITT) participants with a baseline and at least 1 post-baseline REU value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
78163|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Pulse Rate up to 10 Weeks|Abnormal pulse rate (tachycardia) is defined as a sitting heart rate (HR) ≥ 100 beats per minute (bpm) that is also ≥ 10 bpm compared to baseline, at last visit if highest baseline HR < 100 bpm.|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline pulse rate value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
78164|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) up to 10 Weeks|"Abnormal DPB (diastolic hypertension) is defined as sitting DBP ≥ 90 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline DBP < 90 mm Hg.~Abnormal SBP (systolic hypertension) is defined as sitting SBP ≥ 140 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline SBP < 140 mm Hg."|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline DBP and SBP value, last-observation-carried forward (LOCF) were included in the analysis. Participants with a normal baseline value and a nonmissing endpoint value for the variable of interest were included in the analysis.||percentage of participants|||Number
78165|NCT01018680|Secondary|Percentage of Participants Who Discontinued Due to an Adverse Event During the 10-Week Treatment Period||Baseline through 10 weeks|All randomized participants were included in the analysis.||percentage of participants|||Number
78166|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Weight Gain and Weight Loss up to 10 Weeks|"Abnormal weight gain (potentially clinically significant [PCS] weight gain) is defined as weight gain at last visit ≥ 7% of the baseline weight.~Abnormal weight loss (PCS weight loss) is defined as weight loss at last visit ≥ 7% of the baseline weight."|Up to 10 weeks|Participants with a baseline and at least 1 post-baseline weight value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
78167|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal High Hemoglobin A1c (HbA1c) up to 10 Weeks|Abnormal high HbA1c is defined as a post-baseline HbA1c > 6.1% if baseline HbA1c ≤ 6.1% for lab samples obtained before November 17, 2010 and post-baseline HbA1c > 6.4% if baseline HbA1c ≤ 6.4% for lab samples obtained November 17, 2010 and beyond.|Up to 10 weeks|Number of participants with a normal baseline and at least 1 post-baseline abnormal HbA1C value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
78227|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose|||ng-hr/mL||Standard Deviation|Mean
78168|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Brief Pain Inventory-Severity (BPI-S) Average Pain Score up to 8 Weeks|Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for BPI-S average pain rating. The BPI-S self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S average pain value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
78169|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Weekly Mean of the 24-Hour Average Pain Score up to 8 Weeks|"Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for the weekly mean of the 24-hour average pain ratings. The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain rating assessed on an 11-point numeric rating scale, with scores from 0 (no pain) to 10 (worst possible pain)."|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean of the 24-hour average pain score value, last-observation-carried forward (LOCF) were included in the analysis.||percentage of participants|||Number
78170|NCT01018680|Secondary|Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks|OARSI response is composite Yes/No response assessed at 8 weeks based on decrease in 24-hour average pain ratings, range: 0 (“no pain”) to 10 (“worst possible pain”), improvement in functioning (using WOMAC physical function scores, range: 0 [no difficulty] to 68 [extreme difficulty]), and improvement in participant's impression of illness (using PGAI scores, range: 0 to 10; 10=greatest severity). OARSI responder=large response in pain or function components (50% relative and 20% absolute improvement), or moderate response (20% relative and 10% absolute improvement) in 2 of 3 components.|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline OARSI response value, last-observation-carried forward (LOCF) based on values of each of the 3 components listed in the outcome measure description were included in the analysis.||percentage of responders|||Number
78171|NCT01018680|Secondary|Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period|The Least Squares (LS) Mean percentage estimates of participants using acetaminophen was determined during each week individually over the full 10-week treatment period based on participant’s daily Yes/No assessments for the use of acetaminophen. The LS Mean estimates for the main effect of treatment (average weekly use) were adjusted for baseline value, treatment, investigator (pooled), week, and treatment*week.|Baseline through 10 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly acetaminophen use value were included in the analysis.||percentage of participants||Standard Error|Least Squares Mean
78172|NCT01018680|Secondary|Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks|30-item BPOMS measures positive and negative aspects of mood states (item score: 0=not at all to 4=extremely). 5 negative factors: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusion-bewilderment; 1 positive factor: vigor-activity. Factor scores range: 0 to 20; high scores=negative mood (positive mood for vigor). Total score=sum of 5 negative factor scores minus vigor score; range: -20=least disturbed to 100=most disturbed. Least Squares Mean estimates adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPOMS value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78173|NCT01018680|Secondary|Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks|The PGAI is a participant-rated measure of the severity of osteoarthritis (OA) of the knee the participant has experienced in the past week as indicated on an 11-point numeric rating scale, with scores ranging from 0 to 10, where greater numbers reflect greater severity. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline PGAI value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78174|NCT01018680|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks|The CGI-S scale evaluates the severity of illness at the time of assessment. The scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-S must be administered by a study physician in the presence of the participant or after having been in the presence of the participant. The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline CGI-S value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78175|NCT01018680|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks|Measures pain severity and pain interference with function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Mean interference is the average across the 7 interference items. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S/BPI-I value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78228|NCT01018420|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose|||ng/mL||Standard Deviation|Mean
78229|NCT01018394|Primary|Tobacco Abstinence at 12 Weeks|Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.|week 12|||participants|||Number
78176|NCT01018680|Secondary|Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks|Weekly mean 24-hour night pain and worst pain values are calculated from the participant’s daily assessments of pain at night and worst pain during the previous 24 hours on an 11-point numeric rating scale, with scores from 0 (indicating “no pain”) to 10 (indicating “the worst possible pain”). The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), week, treatment*week, and baseline*week.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline night/worst pain value and at least 1 post-baseline weekly mean 24-hour night/worst pain value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78177|NCT01018680|Secondary|Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks|Self-administered questionnaire captures elements of pain, stiffness, and physical disability in participants with osteoarthritis of the knee and/or hip. Index has 24 questions (5 on pain, 2 on stiffness, 17 on physical function). Each question uses a 5-point numeric rating scale ranging from 0 (none) to 4 (extreme). Pain scores range: 0 to 20. Stiffness scores range: 0 to 8. Physical function scores range: 0 to 68. Higher scores=greater impairment. Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline WOMAC value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78178|NCT01018680|Secondary|Patient Global Impression of Improvement (PGI-I) at 8 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares Mean estimates were adjusted for baseline value of Patient Global Impression of Severity (PGI-S), treatment, investigator (pooled), visit, and treatment*visit. The PGI-S measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline PGI-S rating and at least 1 post-baseline PGI-I rating were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78179|NCT01018680|Primary|Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks|The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain ratings using an 11-point numeric rating scale, with scores from 0 (indicating “no pain”) to 10 (indicating “the worst possible pain”). The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), week, treatment*week, and baseline*week.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean 24-hour average pain value were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
78180|NCT01018511|Secondary|AUCss of Solifenacin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
78181|NCT01018511|Secondary|Tmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||h||Geometric Coefficient of Variation|Geometric Mean
78182|NCT01018511|Secondary|Cminss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
78183|NCT01018511|Secondary|Cmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
78184|NCT01018511|Secondary|CL/F of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||L/h||Geometric Coefficient of Variation|Geometric Mean
78185|NCT01018511|Secondary|Area Under the Curve at Steady State (AUCss) of Tamsulosin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
78186|NCT01018511|Secondary|Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||h||Geometric Coefficient of Variation|Geometric Mean
78187|NCT01018511|Secondary|Minimum Concentration at Steady State (Cminss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
78188|NCT01018511|Secondary|Maximum Concentration at Steady State (Cmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
78189|NCT01018511|Secondary|Apparent Clearance (CL/F) of Tamsulosin||Week 4, Week 8 and Week 12|"Pharmacokinetics Analysis Set (PKAS)- randomized participants who received at least 1 dose of double-blind study drug and had at least 1 quantifiable plasma concentration of tamsulosin OCAS and/or solifenacin. N indicates the number of participants with available data at each timepoint."||L/h||Geometric Coefficient of Variation|Geometric Mean
78190|NCT01018511|Secondary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.||mL/s||Standard Deviation|Mean
78191|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.||mL/s||Standard Deviation|Mean
78192|NCT01018511|Secondary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline PVR volume measured.||mL||Standard Deviation|Mean
78193|NCT01018511|Secondary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.|From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)|Safety Analysis Set (SAF) - consisted of participants who received at least one dose of double blind study drug and for whom any data was reported after intake of the first dose of study drug.||participants|||Number
78194|NCT01018511|Secondary|Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78195|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: General Health|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78196|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78197|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Deviation|Mean
78198|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78199|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78200|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78201|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78202|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||participants|||Number
78203|NCT01018511|Secondary|Percentage of Participants Who Were OAB-q Responders at End of Treatment|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Week 12 (end of treatment)|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||percentage of participants|||Number
78204|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78205|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78206|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78207|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78208|NCT01018511|Secondary|Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health–related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78209|NCT01018511|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health–related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78210|NCT01018511|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78211|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS QoL Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78212|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78213|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78215|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.||nocturia episodes||Standard Error|Least Squares Mean
78216|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.||incontinence episodes||Standard Error|Least Squares Mean
78217|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.||urgency incontinence episodes||Standard Error|Least Squares Mean
78218|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency episode at baseline. LOCF imputation was used.||urgency episodes||Standard Error|Least Squares Mean
78219|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||mL||Standard Error|Least Squares Mean
78220|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||mL||Standard Error|Least Squares Mean
78221|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.||micturitions||Standard Error|Least Squares Mean
78222|NCT01018511|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence~TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and Week 12|FAS population. LOCF imputation was used.||units on a scale||Standard Error|Least Squares Mean
78223|NCT01018511|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and Week 12|Full Analysis Set (FAS)-participants who received at least 1 dose of double-blind study drug and had either a total IPSS or TUS at baseline and at least 1 postbaseline total IPSS or TUS. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
78224|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Moxifloxacin)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia’s adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after dose|||milliseconds||Standard Deviation|Mean
78225|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Colchicine)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia’s adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to first dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after first dose|||milliseconds||Standard Deviation|Mean
78226|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose|||ng-hr/mL||Standard Deviation|Mean
78232|NCT01018264|Secondary|Parkinson's Disease Quality of Life Scale (PDQOL)|This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life.|12 weeks|||units on a scale||Standard Deviation|Mean
78233|NCT01018264|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total|To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability).|12 weeks|||units on a scale||Standard Deviation|Mean
78234|NCT01018264|Secondary|Number of Urinary Incontinence Episodes Per 24 Hour Period|This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity.|12 weeks|||Number of incontinence episodes/24 hours||Standard Deviation|Mean
78235|NCT01018264|Primary|Number of Micturations Per 24 Hour Period|The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson’s disease (PD) patients as measured by voiding diaries.|12 weeks|||Number of micturations per 24 hours||Standard Deviation|Mean
78236|NCT01018186|Primary|Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. Holter monitor data were transmitted to a centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||beats per minute||Standard Deviation|Mean
78237|NCT01018186|Primary|Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart’s rhythm while the monitor is worn. At the end of the 24 hour period, the data from the monitor are downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||beats per minute||Standard Deviation|Mean
78238|NCT01018186|Primary|Maximum Change From Baseline in the QT Interval Using Bazett’s Correction (QTcB) and QT Interval Using Fridericia’s Correction (QTcF)|The QT interval is an electrocardiogram (ECG) parameter that represents the electrical depolarization and repolarization of the left and right ventricles of the heart. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the ECG. Corrected QT (QTc) is the QT interval corrected for heart rate by using Bazett's formula (QTcB) and Fridericia's formula (QTcF). 12-lead ECG measurements were perfomed at the following scheduled time points: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the value taken pre-dose at screening. The maximum post-Baseline value was derived using all scheduled, unscheduled, and Early Withdrawal ECG assessments. Maximum change from Baseline was calculated as the maximum post-Baseline value minus the value at Baseline.|Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.||Milliseconds (msec)||Standard Deviation|Mean
78239|NCT01018186|Primary|Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52|Visual acuity is defined as the acuteness or clearness of vision. The minimum angle of resolution (MAR) is the angle a viewed object subtends at the eye, usually stated in degrees/minutes of arc. Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts in decimal numbers. The LogMAR scale is used to express the visual acuity in a linear scale as the logarithm to base 10 of the MAR. A lower score indicates better visual acuity; visual acuity decreases with an increasing score. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
78240|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52|NO is the opalescence of the nucleus (central layer) of the lens. Per LOC III, NO ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
78241|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52|NC is the color of the nucleus (central layer) of the lens. Per LOC III, NC ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
78319|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 8|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.|||||
78320|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 4|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.|||||
78242|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52|C is defined as the opacification of the cortex (outer layer) of the lens. Per LOC III, C ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
78243|NCT01018186|Primary|Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52|Funduscopic examination was performed at Baseline, Week 28, and Week 52 to measure the horizontal cup-to-disc ratio of both eyes. The horizontal cup-to-disc ratio is the ratio of the horizontal diameter of the physiological cup to that of the horizontal diameter of the optic disc. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
78244|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52|Intraocular pressure (IOP) is the fluid pressure inside the eye. IOP was measured twice for each eye at Baseline, Week 28, and Week 52 using Goldmann Applanation tonometry. The second IOP reading was used for analysis. The number of participants with a change from Baseline in IOP of <0 mmHg, >=0 to <4 mmHg, >=4 to <7 mmHg, >=7 to <11 mmHg, and >=11 mmHg are presented. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
78245|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52|P is defined as the opacification at the back of the lens adjacent to the capsule (or bag) in which the lens sits. An event of P is defined as an increase of >=0.3 from Baseline in LOCS III grade for P in either eye at any time post-Baseline. Per LOC III, P ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
78246|NCT01018186|Primary|Maximum Change From Baseline in Pulse Rate|Pulse rate was measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20,Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population||Beats per minute||Standard Deviation|Mean
78247|NCT01018186|Primary|Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP)|SBP and DBP were measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum and minimum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population||Millimeters of mercury (mmHg)||Standard Deviation|Mean
78248|NCT01018186|Primary|Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline|A detailed oropharyngeal examination was done at all clinic visits for visual/clinical evidence of oral candidiasis over the entire Treatment Period (worst case any time post-Baseline). For participants with visual/clinical evidence of candidiasis during the Treatment Phase of the study, a culture swab was taken and analyzed for infection.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
78249|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 52. The ratio of the Week 52 LSGM to the Baseline LSGM was calculated as the value at Week 52 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 52|UC Population. Only those participants available at the specified time point were analyzed.||Ratio of LSGM of UCE to Baseline|||Number
78250|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 28. The ratio of the Week 28 LSGM to the Baseline LSGM was calculated as the value at Week 28 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 28|UC Population. Only those participants available at the specified time point were analyzed.||Ratio of LSGM of UCE to Baseline|||Number
78251|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline|A 24-hour urine sample was collected, and the least square geometric mean (LSGM) for 24-hour urinary cortisol excretion (UCE) was calculated at Baseline and at Week 12. The ratio of the Week 12 LSGM to the Baseline LSGM was calculated as the value at Week 12 divided by the value at Baseline. Analysis was performed using analysis of covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 12|Urinary cortisol (UC) Population: participants in the ITT Population whose urine samples did not have confounding factors that affected the interpretation of results. These participants were determined prior to breaking the blind. Only those participants available at the specified time point were analyzed.||Ratio of LSGM of UCE to Baseline|||Number
78252|NCT01018186|Primary|Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion|"A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion (UCE) at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. Any visit post-baseline (AVPB) value was derived using laboratory assessments performed at scheduled, unscheduled, and Early Withdrawal visits. Participants who had a shift from Baseline in their post-Baseline UCE values relative to the normal range, are presented in the To high and To low categories. Participants whose post-Baseline UCE values were unchanged (e.g., High to High) or whose value became normal, are presented in the To normal or no change category. The normal range for UCE is defined as: 11 to 138 nanomoles per 24 hours (nmol/24 hr) for participants >=18 years of age, 8.3 to 151.7 nmol/24 hr for participants 14 to 17 years of age, and 2.8 to 124.2 nmol/24 hr for participants 12 and 13 years of age."|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
78253|NCT01018186|Primary|Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hemoglobin values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
78254|NCT01018186|Primary|Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hematocrit values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1.0||Standard Deviation|Mean
78255|NCT01018186|Primary|Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected to determine the eosinophil count, total ANC, platelet count, and WBC count at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
78256|NCT01018186|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage||Standard Deviation|Mean
78257|NCT01018186|Primary|Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/BUN values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
78258|NCT01018186|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
78333|NCT01017575|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.|From Week 4 up to Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
78259|NCT01018186|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
78260|NCT01018186|Primary|Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of albumin and total protein values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
78261|NCT01018186|Primary|Number of Participants With Severe Asthma Exacerbations During the Treatment Period|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population||participants|||Number
78262|NCT01018186|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication||participants|||Number
78263|NCT01018134|Secondary|Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).|"Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~%Body Surface Area Affected the Rule of Nine was be used."|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.||percentage of Body Surface Area Affected||Standard Deviation|Mean
78264|NCT01018134|Secondary|Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28|Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.||units on a scale||Standard Deviation|Mean
78265|NCT01018134|Secondary|Mean Change From Baseline in PGA Score at Day 28 Using the ITT|Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary endpoint analysis.||units on a scale||Standard Deviation|Mean
78266|NCT01018134|Primary|Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).|"The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28.~Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.~A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success."|Day 28|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.||percentage of Participants|||Number
78289|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM sinus headache/pressure or facial pain/pressure score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78267|NCT01018134|Primary|Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28|"The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)~The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population.~On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1.~A score of 0 = Clear or 1= Almost Clear was considered clinical success.~A patient will be considered a Clinical Failure if: the patient’s PGA score is > 1, the patient was considered to have an insufficient therapeutic response"|28 days|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.||percentage of participants|||Number
78268|NCT01018095|Secondary|TV Culture Positive Result|Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.|3 months post-enrollment|Participants who returned for their 3 mo follow up visit||participants|||Number
78269|NCT01018095|Primary|TV Culture Positive Result|At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.|test-of-cure visit at 6-12 days post-treatment completion|Participants who returned for their test of cure visit||participants|||Number
78270|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Multi-Dimensional Anxiety Scale for Children (MASC)|"Multidimensional Anxiety Scale (MAS): Anxiety will be followed using the Multidimensional Anxiety Scale for Children (MASC), which has been developed by Dr. John March at Duke University and is now considered the preferred instrument for rating anxiety. The MASC asks the patient how they have been thinking and acting recently. It has a maximum possible score of 117 and a minimum score of 0. Higher score on this scale indicates greater severity of anxiety in children.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4.||units on a scale||Standard Deviation|Mean
78271|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Child Depression Inventory - Short Version (CDI-S) Scale|"Depression Inventory-Short Version (DI-S): Depression severity will be rated by using the Depression Inventory-Short Version (DI-S). This 10 item scale takes about 5 minutes to complete. It has excellent psychometric properties and is designed for repeated administrations over time. The maximum possible score of 20, and a minimum score of 0. Higher score on this scale indicates greater severity of depression in children.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 3). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3.||units on a scale||Standard Error|Mean
78272|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the DuPaul Attention Deficit Hyperactivity Disorder Rating Scale.|"DuPaul ADHD Rating Scale: The presence of ADHD symptoms will be assessed using the DSM-IV version of the ADHD rating scale developed by DuPaul. This scale has been normed in large clinical and community samples and has excellent psychometric properties including a test-retest reliability over a 2-week period of 0.93 and significant correlations with direct observations of classroom behavior. The scale has a maximum possible score of 72, and a minimum of 0. The scale ranges from 0 (the best possible outcome) to 70 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6 weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4.||units on a scale||Standard Deviation|Mean
78273|NCT01018056|Secondary|Urine Analysis||Baseline, and at 2, 4, and 6 weeks||||||
78274|NCT01018056|Secondary|The Change From Baseline to 6-week in Plasma Amino Acid Levels|Blood testing was performed at baseline and at each clinic visit. Data shown below reflects baseline Glutamic Acid minus Week 6 Glutamic Acid, and baseline Serine minus Week 6 Serine levels; as acquired from the blood tests during these respective clinic visits.|Baseline and 6 weeks.|||micromol/L||Standard Deviation|Mean
78275|NCT01018056|Secondary|Complete Blood Count (CBC)||Screen and at 2, 4, and 6 weeks||||||
78276|NCT01018056|Secondary|Comprehensive Metabolic Panel (CMP).||Screen and at 2, 4, and 6 weeks||||||
78277|NCT01018056|Secondary|Body Weight and Physical Examination.||Screen, at Baseline, and at 2, 4, 6, and 8 weeks||||||
78278|NCT01018056|Secondary|Measurement of Vital Signs (BP, Pulse).||Screen visit, Baseline, and at 2, 4, 6, and 8 weeks||||||
78279|NCT01018056|Secondary|The Use of an Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.||Baseline, and at 2, 4, 6, and 8 weeks.||||||
78280|NCT01018056|Secondary|Changes in the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) From Baseline to 6-weeks.|"Secondary outcome for obsessive-compulsive behaviors will be measured by changes in the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from baseline to 6-weeks.~The severity of OCD was evaluated using either the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) or Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The (C)Y-BOCS is the most widely used instrument to assess the severity of obsessive-compulsive symptoms in research studies involving children. The (C)Y-BOCS has well established psychometric properties. The scale ranges from 0 (the best possible outcome) to 10 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|||units on a scale||Standard Error|Mean
78372|NCT01017237|Secondary|Heart Rate|Per EKG monitor|Duration of surgery|per protocol||Beats per minute||Standard Deviation|Mean
78373|NCT01017237|Secondary|Heart Rate|Heart rate per EKG monitor|Prior to sedation|per protocol||Beats per minute||Standard Deviation|Mean
78281|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Patient Global Impression of Improvement (PGI-I).|"Patient Global Impression of Improvement (PGI-I) is a single seven point scale in which the patient/parent is asked to assess the change in overall condition ranging from “very much” improved to “very much worse.”~A score of 1 corresponds to “very much better”; 2 equals “much better;” 3 denotes “a little better”; and 4 represents “no change.” Scores above 4 are used to indicate deterioration, i.e., 5 equals “a little worse;” 6 is “much worse;” and 7 is “very much worse.”~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that only summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)--this applies to all outcome measures reported in the results."|Baseline and 6 weeks|||units on a scale||Standard Error|Mean
78282|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Clinical Global Impression –Improvement (CGI-I).|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to “very much improved”; 2 equals “much improved;” 3 denotes “minimal change”; and 4 represents “no change.” Scores above 4 are used to indicate deterioration, i.e., 5 equals “minimally worse;” 6 is “much worse;” and 7 is “very much worse.”~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks|||units on a scale||Standard Error|Mean
78283|NCT01018056|Secondary|The Change From Baseline to 6-week Scores for the Yale Global Tic Severity Scale (YGTSS) Total Score.|"i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50), total maximum score is 100. This scale has established validity, as assessed by Dr. Walkup and colleagues and is considered the best currently available scale to rate the severity of tics. This scale ranges from 0 (the best possible outcome) to 100 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks|||units on a scale||Standard Deviation|Mean
78284|NCT01018056|Primary|The Change From Baseline to 6-week Scores for The Total Tic Subscale (TTS)|"The primary outcome measure is effective tic suppression as determined by the difference in the Total Tic subscale (TTS) scores of the Yale Global Tic Severity Scale (YGTSS) at baseline and 6 weeks.~i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50). The Total Tic Score (TTS: 0-50) has been selected as the primary outcome measure. The scale ranges from 0 (the best possible outcome) to 50 (the worst possible outcome). This scale is considered the best currently available scale to rate the severity of tics. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|||units on a scale||Standard Deviation|Mean
78285|NCT01018030|Secondary|Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)|Participants who required the use of an antibiotic due to the development of FBRS during the 2-week treatment period and the 2-week follow-up period were included in the analysis.|4 weeks|ITT Population||participants|||Number
78286|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM postnasal drip score was calculated as the PM postnasal drip score averaged over the entire treatment period minus the PM postnasal drip score over the baseline period (defined as the average PM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78287|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM postnasal drip score was calculated as the AM postnasal drip score averaged over the entire treatment period minus the AM postnasal drip score over the baseline period (defined as the average AM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78288|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily postnasal drip score was calculated as the daily postnasal drip score averaged over the entire treatment period minus the daily postnasal drip score over the baseline period (defined as the average daily postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78314|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 4|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.|||||
78290|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM sinus headache/pressure or facial pain/pressure score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78291|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily sinus headache/pressure or facial pain/pressure score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78292|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM nasal congestion/stuffiness score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78293|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM nasal congestion/stuffiness score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78294|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily nasal congestion/stuffiness score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78295|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in PM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the evening (PM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in PM MSS was calculated as the PM MSS averaged over the entire treatment period minus the PM MSS over the baseline period (defined as the average PM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78296|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in AM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the morning (AM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in AM MSS was calculated as the AM MSS averaged over the entire treatment period minus the AM MSS over the baseline period (defined as the average AM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Mean
78297|NCT01018030|Secondary|First Time to Symptom Improvement|Symptom improvement was defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all three major symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) on 2 consecutive 12-hour assessments. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe.|Entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||days||Full Range|Median
78298|NCT01018030|Primary|Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)|The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of double-blind study drug. Participants with missing diary data at baseline or post-baseline were not included in this analysis.||units on a scale||Standard Error|Least Squares Mean
78299|NCT01017952|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
78300|NCT01017952|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
78301|NCT01017952|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population||Participants|||Number
78302|NCT01017952|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
78303|NCT01017874|Secondary|Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)|The LCSS data included participant ratings of 6 symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) and 3 summary items (overall symptom severity, interference with daily activities, and overall QoL). Participants recorded their ratings for each item, by placing a mark on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (lower symptom burden, less interference with normal activity, or better QoL) to 100 mm (higher symptom burden, more interference with normal activity, or worse QoL). TWQ was evaluated from date of randomization to first date of worsening, defined as a half standard deviation change as determined from the corresponding baseline item score in the pooled treatment group. For participants not known to have worsened or who were lost to follow-up, TWQ was censored at date of the participant's last LCSS assessment.|Every cycle while on-study therapy and at 3 months post last dose|Participants who received at least 1 dose of study treatment and had LCSS data available. Participants censored (Pemetrexed + Cisplatin + Gefitinib, Gefitinib): Loss of appetite (33,59), Fatigue (42,54), Cough (52,65), Dyspnea (51,66), Hemoptysis (69,74), Pain (48,67), Overall symptoms (52,63), Interference (42,59), Overall QoL (51,51).||months||Full Range|Median
78315|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1|The area under the concentration versus time curve from time 0 to infinity [AUC(0-inf)] is reported during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 1.||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
78316|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 3|The maximum observed serum concentration of IMC-1121B (ramucirumab) at steady state (Cmax,ss) during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 3.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
78374|NCT01017237|Secondary|Mean Arterial Blood Pressure|Measured using automated blood pressure monitor|During duration of surgery|per protocol||mmHg||Standard Deviation|Mean
78304|NCT01017874|Secondary|Duration of Tumor Response|The duration of a complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria was defined as the time from first objective status assessment of CR or PR to the first time of objective disease progression or death as a result of any cause. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared. Participants who were not known to have died or had objective progression of disease as of the data-inclusion cut-off date were censored at the date of the participant’s last complete objective progression-free disease assessment prior to that cut-off date.|Date of initial response to the date of measured PD or death up to 34.43 months|A subset of the Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned who had confirmed CR or PR. Pemetrexed + Cisplatin + Gefitinib= 19, Gefitinib= 9.||months||95% Confidence Interval|Median
78305|NCT01017874|Secondary|Time to Progressive Disease (TtPD)|TtPD was defined as the time from randomization to the first date of objectively determined progressive disease (PD). For participants who were not known to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, or who had died without objective progression of disease, TtPD was censored at the date of the participant’s last objective progression-free disease assessment prior to cut-off date.|Randomization to the first date of measured PD up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed + Cisplatin + Gefitinib (G) =37, G=26.||months||95% Confidence Interval|Median
78306|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR was defined as the percentage of randomized participants with overall response of CR, PR or SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared; SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD. PD defined as at least 20% increase in the sum of LD of target, lesions taking as reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions or progression of nontarget lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.||percentage of participants||95% Confidence Interval|Number
78307|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the percentage of randomized participants having a best overall study response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and the appearance of no new lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.||percentage of participants||95% Confidence Interval|Number
78308|NCT01017874|Secondary|Overall Survival (OS)|OS was the duration from randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date for a particular analysis, OS was censored at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date included adverse event date, lesion assessment date, visit date, and last known alive date).|Randomization up to date of death from any cause up to 57.13 months|ITT population: All data from all randomized participants according to the treatment they were assigned.||months||95% Confidence Interval|Median
78309|NCT01017874|Primary|Progression Free Survival (PFS)|PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.|Randomization to the first date of measured PD or death up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed+Cisplatin+Gefitinib=32, Gefitinib=22.||months||95% Confidence Interval|Median
78310|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 3|The area under the concentration versus time curve over the dosing interval at steady state [AUC(tau,ss)] is reported during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 3.||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
78311|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 2, Day 1|AUC was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Approximately Week 1 (Cycle 2, Day 1)|No participants were analyzed.|||||
78312|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 15|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 3 (Cycle 1, Day 15)|No participants analyzed.|||||
78313|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 8|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.|||||
78321|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1|Maximum observed concentration of IMC-1121B (ramucirumab) in serum during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 1.||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
78322|NCT01017731|Secondary|Number of Participants With Drug-Related Adverse Events (AEs)|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline up to data cut off (approximately 105.6 weeks)|Safety population: participants who received any quantity of ramucirumab, regardless of their eligibility for the study.||participants|||Number
78323|NCT01017731|Primary|Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants|All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is defined as a QTc exceeding 10 milliseconds (msec) with a lower 90% confidence interval (CI) exceeding 5 msec at any postdose time points per the International Conference on Harmonization (ICH) E14 guidelines for non-thorough QT studies (ICH 2005; ICH 2008). Least squares (LS) mean was calculated using a linear mixed model for repeated measures (MMRM) and adjusted for serum concentration.|Baseline, Cycle 3 (1 cycle=21 days)|Participants who received a full study dose of ramucirumab in Cycle 3 and had at least 1 pretreatment ECG and postinfusion ECG at scheduled times as specified in the protocol.||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
78324|NCT01017653|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|18 months|||months||95% Confidence Interval|Median
78325|NCT01017653|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria. A complete response is defined as the disappearance of all enhancing rumor and mass effect, off all corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. A partial response is defined as greater than or equal to 50% reduction in tumor size on MR (magnetic resonance) / CT(computed tomography) by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|16 months|2 patients' response was unknown due to withdrawal from the study before an MRI was performed.||participants|||Number
78326|NCT01017653|Secondary|Relationship Between Epidermal Growth Factor Receptor (EGF-R) Mutational Analysis and Efficacy or Toxicity|Number of participants with an abnormal fluorescence in situ hybridization (FISH) interpretation that 1) survived < 6 months and 2) experienced a ≥ grade 3 toxicity as graded per CTCAE v.3.0|16 months|Insufficient data to analyze the relationship between EGF-R analysis and efficacy or toxicity. Data was not collected for this outcome.||participants|||Number
78327|NCT01017653|Secondary|Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose|Average change in corticosteroid dose from baseline to the end of cycle 1.|Baseline and Day 29|Insufficient data to analyze the effect of the treatment regimen on corticosteroid dose. Data was not collected for this outcome.||mg|||Number
78328|NCT01017653|Secondary|Safety of Panitumumab in Combination With Irinotecan|Number of participants experiencing a toxicity ≥ grade 3 as graded per CTCAE v.3.0|16 months|||participants|||Number
78329|NCT01017653|Secondary|One-Year Overall Survival|Percentage of participants surviving 12 months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of the death due to any cause.|1 year|||percentage of participants||95% Confidence Interval|Number
78330|NCT01017653|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), and 3) concomitant steroid use (as reported by the investigator).|6 months|||percentage of participants||95% Confidence Interval|Number
78331|NCT01017575|Other Pre-specified|Number of Participants With Grade 3 to 4 Laboratory Abnormalities|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.|From screening up to Week 12 (treatment period)|All treated participants who received at least 1 dose of study therapy.||Participants|||Number
78332|NCT01017575|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Baseline up to 30 days after last dose of study drug|All treated participants who received at least 1 dose of study therapy.||participants|||Number
78375|NCT01017237|Secondary|Mean Arterial Blood Pressure|Blood pressure per automated monitor|Immediately prior to surgery|per protocol||mmHg||Standard Deviation|Mean
78334|NCT01017575|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24|SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.|Follow up Week 12, Follow up Week 24|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
78335|NCT01017575|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.|Week 12|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
78336|NCT01017575|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.|Week 4|All treated participants who received at least 1 dose of study therapy.||percentage of participants|||Number
78337|NCT01017549|Secondary|Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.|Serious adverse device related events reported from treatment through 6 month follow-up and at 1-year follow-up are reported.|Through 6 months|All patients treated were analyzed at 6 months except for 1 patient who was lost to follow-up.||events|||Number
78338|NCT01017549|Primary|Number of Participants With Delivery of 34 Gy in 10 Fractions|Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)|measured at end of 10th fraction, usually within 7 days|All patients treated were analyzed||Participants|||Number
78339|NCT01017536|Secondary|Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of CD4+ and CD8+ T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with Ag85A, Ag85B, and TB10.4 peptide pools.|Study days 28 and 56|percentage of CD4 or CD8 T-cell response||percentage of T-cell response||95% Confidence Interval|Median
78340|NCT01017536|Secondary|Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182)||6 months (day 182) post Study Day 0 vaccination.|||Change in copies/mL over time||95% Confidence Interval|Median
78341|NCT01017536|Primary|CD4+ Lymphocyte Count|Assess the effect of AERAS-402 on the CD4+ lymphocyte count after 6 months in HIV-infected, BCG-vaccinated adult subjects with no evidence of active tuberculosis (TB disease) Change in cells/mm^3 pre-vaccination to Study Day 182|CD4+ counts from samples collected on Study days 0 and 182.|||cells/mm^3||95% Confidence Interval|Median
78342|NCT01017497|Secondary|Rate of Death Due to Neurologic Causes|The rate of death due to neurologic causes is defined as the percentage of participants whose death is attributable to the progression of neurological disease.|24 months after SRS|||percentage of participants|||Number
78343|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT) from baseline to 3 months after SRS. The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Change score = score at 3 months after SRS - score at baseline. Negative change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.||Change in seconds baseline to 3 months||Standard Error|Mean
78344|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in MMSE scores from baseline to 3 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The minimum score is 0 and teh maximum score is 30 with higher MMSe scores indicating better cognition. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.||Change in score from baseline to 3 month||Standard Error|Mean
78345|NCT01017497|Secondary|Quality of Life at 3 Months After SRS as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline to 3 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.||Change in score from baseline to 3 month||Standard Error|Mean
78346|NCT01017497|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|24 months after SRS|||months||95% Confidence Interval|Median
78347|NCT01017497|Secondary|12 Month Rate of Distant Brain Metastases|The 12-month rate of distant brain metastases is defined as the percentage of participants with the appearance of new brain metastasis located away from the previously treated lesion (i.e. distant brain failure) 12 months after SRS. Time to the appearance of new brain metastasis was defined as the time between SRS and distant brain failure. Patients without new distant brain metastases as of the last follow-up were censored at the last follow-up date. Kaplan-Meier methods were used to describe the time to distant brain failure.|12 month after SRS|The rate of distant brain metastases is a patient-specific outcome. Of the 49 patients enrolled, six had insufficient post-SRS imaging data to be included in this analysis.||percentage of participants||95% Confidence Interval|Number
78376|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured by capnography at nares|Duration of surgery|per protocol||mmHg||Standard Deviation|Mean
78348|NCT01017497|Secondary|Rate of Radionecrosis at SRS Treatment Site|The rate of radionecrosis is defined as the proportion of lesions with an indication of radiation-associated changes but no evidence of viable tumor on follow-up imaging (and confirmed by tissue biopsy whenever possible).|24 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.||proportion of lesions|Participants|95% Confidence Interval|Number
78349|NCT01017497|Primary|12-month Local Control Rate|The 12-month local control rate is the percentage of lesions without recurrence at the lesion site 12 months after SRS. Time to local recurrence was defined as the time between SRS and local recurrence. If local recurrence did not occur, the time to local recurrence was censored at last follow-up (including deaths without local recurrence). Kaplan-Meier methods were used to describe the time to local recurrence.|12 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.||percentage of lesions|Participants|95% Confidence Interval|Number
78350|NCT01017263|Primary|Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.|The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.|Baseline to end of study|Study terminated early - no analysis performed on the single subject with data.|||||
78351|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-6) mm^2/s||Inter-Quartile Range|Median
78352|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-6) mm^2/s||Inter-Quartile Range|Median
78353|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-1)||Inter-Quartile Range|Median
78354|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. By measuring extracellular extravascular volume fraction (EVF) it is possible to gain information on brain tissue perfusion. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-1)||Inter-Quartile Range|Median
78355|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||mmol/kg∙s||Inter-Quartile Range|Median
78356|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||mmol/kg∙s||Inter-Quartile Range|Median
78357|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-2) min(-1)||Inter-Quartile Range|Median
78377|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured via capnography at nares|Immediately prior to sedation|per protocol||mmHg||Standard Deviation|Mean
78378|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|per protocol||percentage of patients|||Number
78379|NCT01017237|Primary|Amnesia: Lack of Picture Recall at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia|Day of surgery prior to discharge|per protocol||percentage of patients|||Number
78358|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume, with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.||10(-2) min(-1)||Inter-Quartile Range|Median
78359|NCT01017250|Secondary|Steroid Usage After Stereotactic Radiosurgery (SRS)|Number of patients using steroids at baseline and at 2 months after SRS.|2 months after SRS 2 months after SRS 2 months after SRS|||participants|||Number
78360|NCT01017250|Secondary|Performance Status at 2 Months After Stereotactic Radiosurgery (SRS)|"Number of patients with a 10% decline in Karnofsky Performance Status (KPS) from baseline to 2 months after SRS. KPS is rated on a 0 to 100 scale representing a patient's ability to perform normal activity, ability to do active work, and the need for assistance. A score of 100 is perfect health and 0 represents death."|2 months after SRS|Intent to Treat: only 13 out of 15 patients completed month 2 KPS scores||participants|||Number
78361|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS) as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT). The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Shorter time scores indicates improved cognition. Change score = score at 2 months after SRS - score at baseline. Negative change scores indicate improved cognition.|2 months after SRS|Intent to treat: only 14 of 15 patients completed the month 2 questionnaire||seconds||Standard Error|Mean
78362|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline to 2 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score at 2 months after SRS - score at baseline. Higher scores for this scale indicate improved quality of life(QOL). Positive change scores indicate improved cognition.|2 months after SRS|Intent to Treat: only 14 patients out of 15 completed the month 2 questionnaire||units on a scale||Standard Error|Mean
78363|NCT01017250|Secondary|Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS)|Quality of life as measured by the change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) scores from baseline to 2 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Higher scores for all scales indicate improved quality of life (QOL).Change score = score at 2 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|2 months after SRS|Intent to Treat; only 10 patients out of 15 completed the month 2 questionnaire.||units on a scale||Standard Error|Mean
78364|NCT01017250|Secondary|Overall Survival(OS)|Time in months from the start of stereotactic radiosurgery (SRS) to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat||months||95% Confidence Interval|Median
78365|NCT01017250|Secondary|Radiographic Response at Month 2|Radiographic response at 2 months after stereotactic radiosurgery (SRS) assessed by MRI and based on modified Response Assessment in Neuro-Oncology (RANO) criteria.Per RANO, complete response (CR) is the disappearance of all target lesions;Partial Response(PR)is a >=30% decrease in the sum of the longest diameter of target lesions.|2 months after SRS|Intent to treat||Participants|||Number
78366|NCT01017250|Secondary|Progression-free Survival (PFS)|Time in months from the start of stereotactic radiosurgery (SRS) to the date of first progression according to Revised Assessment in Neuro-Oncology (RANO)criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Per RANO, progression is defined as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in a non-target lesion or the appearance of new lesions.|1 year|Intent to treat||months||95% Confidence Interval|Median
78367|NCT01017250|Primary|Central Nervous System (CNS) Toxicity|"Number of participants who experience Grade 3 or higher adverse events in the Nervous System Disorder domain of Common Toxicity Criteria for Adverse Events (CTCAE) v4.0."|2 months after Stereotactic Radiosurgery|The number of participants with CNS toxicity is reported.||participants|||Number
78368|NCT01017237|Secondary|Bispectral Index Score (BIS)|Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state.|During surgery duration.|per protocol||units on a scale||Standard Deviation|Mean
78369|NCT01017237|Secondary|Ramsey Sedation Scale Score|Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive|During surgical procedure|per protocol||units on a scale||Standard Deviation|Mean
78370|NCT01017237|Secondary|Patient Satisfaction With Sedation Technique|Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied|after completion of surgery (within 15 minutes)|per protocol||units on a scale||Standard Deviation|Mean
78371|NCT01017237|Secondary|Surgeon Satisfaction With Sedation Technique|Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)|After surgery completed: day of surgery, within 15 minutes|per protocol||units on a scale||Standard Deviation|Mean
78382|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.|Lack of recall of picture demonstrates presence of amnesia on day following surgery|One day after surgery|per protocol||percentage of patients|||Number
78383|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery|Lack of recall of picture shown at this time indicates presence of amnesia|Day of Surgery prior to discharge|per protocol||percentage of patients|||Number
78384|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.|Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.|One day after surgery|per protocol||percentage of patients|||Number
78385|NCT01017237|Primary|Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.|Percentage of patients unable to recall picture|Day of Surgery prior to discharge|Per protocol||percentage of patients|||Number
78386|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.|Lack of recall of picture shown indicates presence of amnesia the day following surgery.|One day after surgery|Per protocol||percentage of patients|||Number
78387|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pulse oximetry|During surgical procedure|per protocol||Percent oxyhemoglobin saturation||Standard Deviation|Mean
78388|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pule oximeter|Immediately prior to surgery|per protocol||Percent oxyhemoglobin saturation||Standard Deviation|Mean
78389|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Rate of respirations|During surgical procedure|per protocol||Breaths per Minute||Standard Deviation|Mean
78390|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Respirations per minute|Immediately prior to sedation|Randomized per protocol||Breaths per Minute||Standard Deviation|Mean
78391|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown Prior to Sedation.|Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery|Day of surgery prior to discharge|Randomized per protocol||percentage of participants|||Number
78392|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78393|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78394|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78395|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness: skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of drying reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78396|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study||participants|||Number
78397|NCT01017146|Secondary|Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-6=small effect on the participant’s life; 7-12=moderate effect on the participant’s life; 13-18=very large effect on the participant’s life; 19-30=extremely large effect on the participant’s life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.||scores on a scale||Standard Deviation|Mean
86394|NCT00943592|Primary|Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
78398|NCT01017146|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-5=small effect on the participant’s life; 6-10=moderate effect on the participant’s life; 11-20=very large effect on the participant’s life; 21-30=extremely large effect on the participant’s life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.||Scores on a scale||Standard Deviation|Mean
78399|NCT01017146|Secondary|Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set||participants|||Number
78400|NCT01017146|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
78401|NCT01017146|Secondary|Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set||participants|||Number
78402|NCT01017146|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.||days||95% Confidence Interval|Median
78403|NCT01017146|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.||lesion counts||Standard Deviation|Mean
78404|NCT01017146|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.||percent change||Standard Deviation|Mean
78405|NCT01017146|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
78406|NCT01017146|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set||participants|||Number
78407|NCT01017146|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.||lesion counts||Standard Deviation|Mean
78408|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78409|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78410|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78411|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness=skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of dryness reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants||participants|||Number
78412|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study||participants|||Number
78413|NCT01017120|Secondary|Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-6=small effect on the participant’s life; 7-12=moderate effect on the participant’s life; 13-18=very large effect on the participant’s life; 19-30=extremely large effect on the participant’s life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Week 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.||scores on a scale||Standard Deviation|Mean
78414|NCT01017120|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-5=small effect on the participant’s life; 6-10=moderate effect on the participant’s life; 11-20=very large effect on the participant’s life; 21-30=extremely large effect on the participant’s life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.||scores on a scale||Standard Deviation|Mean
78415|NCT01017120|Secondary|Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12|A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||closed comedone count||Standard Deviation|Mean
78416|NCT01017120|Secondary|Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12|An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||open comedone count||Standard Deviation|Mean
78417|NCT01017120|Secondary|Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12|A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||nodule count||Standard Deviation|Mean
78418|NCT01017120|Secondary|Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12|A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||pustule count||Standard Deviation|Mean
78492|NCT01016678|Primary|Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose|All data was collected and measured from self-reported patient diaries|3 years|Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours||percentage of attacks|Participants||Number
78419|NCT01017120|Secondary|Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12|A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||papule count||Standard Deviation|Mean
78420|NCT01017120|Secondary|Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set||participants|||Number
78421|NCT01017120|Secondary|Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set||participants|||Number
78422|NCT01017120|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
78423|NCT01017120|Secondary|Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set||participants|||Number
78424|NCT01017120|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.||days||95% Confidence Interval|Median
78425|NCT01017120|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.||lesion counts||Standard Deviation|Mean
78426|NCT01017120|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.||percentage change||Standard Deviation|Mean
78427|NCT01017120|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.||participants|||Number
78428|NCT01017120|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set||participants|||Number
78464|NCT01016912|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .|At Week 4 on treatment|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
78429|NCT01017120|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.||lesion counts||Standard Deviation|Mean
78430|NCT01017042|Primary|Area Under The Concentration Time Curve From Zero Through Infinity (AUC∞)|"The area under the plasma concentration versus time curve extrapolated to infinity.~AUC∞ is calculated as the sum of Total AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant"|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).|||pg-hr/ml||Standard Deviation|Mean
78431|NCT01017042|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (96 Hours) (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration (96hours), calculated by the linear trapezoidal rule.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).|||pg-hr/ml||Standard Deviation|Mean
78432|NCT01017042|Secondary|Electrocardiogram Corrected QT Interval (QTcF)|Corrected QT interval by Fridericia’s formula -Measured at baseline, 0.5, 1, 2, and 4 hours|Measured at baseline, 0.5, 1, 2, and 4 hours|All participants||Milliseconds||Standard Deviation|Mean
78433|NCT01017042|Primary|Maximum Plasma Concentration|The maximum or peak concentration that the drug reaches in the plasma.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).|||picograms/ml||Standard Deviation|Mean
78434|NCT01017029|Secondary|Participants With at Least One Occurrence of Composite Treatment Failure Events|Comparison of 6-months cumulative incidence of composite treatment failure events (BPAR ≥ 2R, rejection with hemodynamic compromise, graft loss, or death) between delayed everolimus arm and immediate everolimus arm|6 months|||participants||95% Confidence Interval|Number
78435|NCT01017029|Secondary|Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group|CMV infection is defined as pp65 antigenemia or DNAemia|6 months|safety population||participants||95% Confidence Interval|Number
78436|NCT01017029|Secondary|Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group|LDL = low density lipoprotein|6 months|safety population||participants||95% Confidence Interval|Number
78437|NCT01017029|Secondary|Hazard Cox’s Model Analysis of Pericardial/Pleural Effusions|Pericardial effusions: any pericardial effusion defined as at least moderate (i.e. measuring at least 2.0 cm in diastole, in the point of largest distance between the pericardial leaflets), with or without signs of hemodynamic compromise, or leading to drainage or to prolonged hospitalization. Pleural effusions: need for surgical drainage tubes for longer than 7 days after surgery and subsequent pleural effusions leading to drainage. CI = confidence interval, HR = hazard ratio, MDRD = Modification of Diet in Renal Disease|6 months|safety population||participants|||Number
78438|NCT01017029|Secondary|Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group||6 months|safety population||participants|Participants|95% Confidence Interval|Number
78439|NCT01017029|Primary|Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group|Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm|6 months|safety population||participants||95% Confidence Interval|Number
78440|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|by protocol||pg-h/ml||Standard Deviation|Mean
78441|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.|Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.|0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing|by protocol||pg-h/ml||Standard Deviation|Mean
78442|NCT01017003|Primary|Maximum Serum Concentration (Cmax)|maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions|Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|per protocol||pg/mL||Standard Deviation|Mean
78443|NCT01016977|Secondary|Overall Satisfaction With Study Product at Week 12|"Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): What is your overall satisfaction with the study product. Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied."|Week 12|ITT Population||units on a scale||Standard Deviation|Mean
78465|NCT01016912|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.|At Weeks 4 and 12 on treatment|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
78444|NCT01016977|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
78445|NCT01016977|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
78446|NCT01016977|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
78447|NCT01016977|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.||units on a scale||Standard Deviation|Mean
78448|NCT01016977|Secondary|Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12|The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population||lesions||Standard Deviation|Mean
78449|NCT01016977|Secondary|Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12|Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population||lesions||Standard Deviation|Mean
78450|NCT01016977|Secondary|Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12|The investigator conducted the overall assessment of the participant’s facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe.|Baseline and Week 12|ITT Population||participants|||Number
78451|NCT01016977|Primary|Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
78452|NCT01016977|Primary|Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
78491|NCT01016678|Primary|Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention|All data was collected and measured from self-reported patient diaries|3 years|94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks||percentage of attacks|Participants||Number
78453|NCT01016977|Primary|Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
78454|NCT01016977|Primary|Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
78455|NCT01016977|Primary|Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
78456|NCT01016977|Primary|Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
78457|NCT01016977|Primary|Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|Intent-to-Treat (ITT) Population: all randomized participants who received study product. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.||units on a scale||Standard Deviation|Mean
78458|NCT01016964|Primary|Change in Hair Count at 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks|||hairs per cm^2||Standard Deviation|Mean
78459|NCT01016938|Secondary|Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation|The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.|2 years|||participants|||Number
78460|NCT01016938|Primary|Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors|"Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm.~The participants’ tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI."|2 years|||participants|||Number
78461|NCT01016912|Secondary|Percentage of Participants With Virologic Failure|Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.|From on-treatment Week 1 to Follow-up Week 24|All participants who received at least 1 dose of study therapy.||percentage of participants|||Number
78462|NCT01016912|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24|SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .|Follow-up Weeks 4, 12, and 24|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
78463|NCT01016912|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory|At Week 12 on treatment|All participants who received at least 1 dose of study therapy.||percentage of participants||80% Confidence Interval|Number
78466|NCT01016912|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.||participants|||Number
78467|NCT01016912|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.||participants|||Number
78468|NCT01016873|Secondary|Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52||Week 52|||CNV as % of Lesion||Standard Deviation|Mean
78469|NCT01016873|Secondary|Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.||Week 12, 28, and 104|||Number of Injections||Standard Deviation|Mean
78470|NCT01016873|Secondary|Time From Mandatory Injection at Day 0 to the First PRN Injection.||52 Weeks|||Weeks||95% Confidence Interval|Median
78471|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"||Percentage of Patients|||Number
78472|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"||Proportion of Patients|||Number
78473|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"||Percentage of Patients|||Number
78474|NCT01016873|Secondary|Change in Mean Visual Acuity (VA)||Weeks 12, 28, 52 and 104.|||Letters||Standard Deviation|Mean
78475|NCT01016873|Primary|Number of Lucentis® Injections Up To And Including Week 52||During the first 52 weeks.|||Injections||Standard Deviation|Mean
78476|NCT01016847|Secondary|Sputum Cell Counts and Differentials||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
78477|NCT01016847|Secondary|Asthma Exacerbation|Asthma exacerbation is defined as the development of an increase in asthma symptoms which results in an increase in the use of asthma medications (typically inhaled corticosteroids and/or parenteral corticosteroids) or the addition of another new asthma medication or antibiotics.|Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
78478|NCT01016847|Secondary|Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
78479|NCT01016847|Secondary|Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
78480|NCT01016847|Secondary|Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
78481|NCT01016847|Primary|Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.|||||
78482|NCT01016834|Secondary|Treatment Confidence|Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.|After 4 migraines or 60 days|||participants|||Number
78483|NCT01016834|Secondary|Treatment Preference|Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).|After 4 migraines or 60 days|||participants|||Number
78484|NCT01016834|Primary|Overall Satisfaction|"Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c Overall satisfaction was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)"|After 4 migraines or 60 days|The Per-protocol (PP) population included all subjects who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures.||Scale of 0-100; 100= very satisfied||Standard Deviation|Mean
78485|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 5||Day 4 to Day 5||||||
78486|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 4||Baseline to Day 4||||||
78487|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 3||Baseline to Day 3||||||
78488|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 2||Baseline to Day 2||||||
78489|NCT01016691|Primary|Mean Change in Intraocular Pressure at Day 1||Baseline to Day 1|per-protocol population||mmHg||Standard Deviation|Mean
78490|NCT01016678|Secondary|To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.|Collected from patient reported paper diaries|3 years|This analysis data was not collected.|||||
78493|NCT01016678|Primary|Number of Participants With 2-hour Pain Free Active Study Drug|All data was collected and measured from self-reported patient diaries|3 years|The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis||Participants|||Number
78494|NCT01016652|Secondary|Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper|Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects|Baseline|Analysis was on those subjects who were randomized to either treatment arm with the intent to treat.||percentage of participants|||Number
78495|NCT01016652|Secondary|Comfortable Wearing Time|Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.|week 4|Analysis was on those subjects randomized to either arm with the intent to treat.||hours||Inter-Quartile Range|Median
78496|NCT01016652|Secondary|Subject Reported Lens Comfort Using CLUE Questionnaire|Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.|week 4|Analysis was on those subjects enrolled and randomized to either one of the arms with intent to treat.||units on a scale||Inter-Quartile Range|Median
78497|NCT01016652|Secondary|Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ|Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).|week 4|The NV Questionnaire was administered to those enrolled in the study and randomized to either treatment arm.||percentage of participants|||Number
78498|NCT01016652|Primary|Monocular Amplitude of Accommodation|The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.|week 4|Analysis was on those who were randomized to either treatment arm with intent to treat. One eye was chosen.||diopters||Inter-Quartile Range|Median
78499|NCT01016652|Primary|Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire|The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.|week 4|Analysis was on those subjects enrolled, randomized into one of two randomized arms, and who completed the study.||units on a scale||Inter-Quartile Range|Median
78500|NCT01016600|Primary|Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age|"Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment.~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul."|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|Participants in Cohort 1, 2, and 3 were not analyzed for this outcome as it is a Phase II outcome measure only. (3) participants in Phase II cohort were not evaluable for response because they did not complete cycle 1.||percentage of participants|||Number
78501|NCT01016600|Secondary|Toxicity Profile (Grade 3/4 Toxicities)|AML ≥18 years or untreated AML ≥60 years|30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))|||participants|||Number
78502|NCT01016600|Secondary|Duration of CR for Complete Responders||Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(6) participants in Cohort 1, (3) participants in Cohort 2, (4) participants in Cohort 3, and (10) participants in Phase II did not have a complete response and are not evaluable for this outcome.||months||Full Range|Median
78503|NCT01016600|Secondary|Relapse Free Survival (RFS)|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))|||months||Full Range|Median
78504|NCT01016600|Secondary|Time to Progression (TTP)|Defined as the interval from the date of the first dose of study drug to the date of progressive disease.|Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))|(2) cohort 1 participants were not evaluable for this outcome measure because (1) was removed for DLT & (1) withdrew from study. (2) phase II participants were not evaluable because both were removed from study in the first cycle for adverse events.||months||Full Range|Median
78505|NCT01016600|Secondary|Event Free Survival|Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))|||months||Full Range|Median
78506|NCT01016600|Secondary|Overall Survival|Defined as the date of first dose of study drug to the date of death from any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))|||months||Full Range|Median
78507|NCT01016600|Secondary|Partial Remission Rate (PR)|Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
79209|NCT01008722|Secondary|Termination or Slowing of Atrial Fibrillation During Ablation|Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus.|acute|||Participants|||Count of Participants
78508|NCT01016600|Secondary|CR With Incomplete Blood Counts Rate|Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
78509|NCT01016600|Secondary|Cytogenetic CR (CRc) Rate|Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
78510|NCT01016600|Secondary|Morphologic Complete Remission Rate (CRm)|Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
78511|NCT01016600|Secondary|Morphologic Leukemia-free State|Defined as < 5% blasts on the BM aspirate with spicules and a count of >200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.||participants|||Number
78512|NCT01016600|Secondary|Response Rate (CRm + CRc + CRi + PR)|"Response rate (CRm + CRc + CRi + PR)~CRm = morphologic complete remission~CRc = cytogenetic complete remission~CRi = morphologic complete remission with incomplete blood count recovery~PR = partial remission"|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response. (1) participant in Cohort one had both CRm and CRc.||participants|||Number
78513|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.~Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.~Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)|||mg/m^2|||Number
78514|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.~Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.~Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)|(1) participant in Cohort 1 did not start treatment. The Phase II cohort was not analyzed because this was a Phase I outcome only.||dose-limiting toxicities|||Number
78515|NCT01016132|Primary|Overall Preference|"Overall preference when comparing study lenses to habitual lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer Habitual Lenses; Strongly Prefer Habitual Lenses."|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||Participants|||Number
78516|NCT01016106|Primary|Heterozygous for Filaggrin (FLG) Null Mutations|Buccal swab samples were obtained from each subject. Deoxyribonucleic acid (DNA) was purified from buccal swabs (IsoHelix Swabs, BocaScientific, Boca Raton, FL) and quantified by ultraviolet spectrophotometry. Purified genomic DNA and controls were amplified by polymerase chain reaction (PCR) from three different regions of FLG exon 3 with three primer sets. PCR products were analyzed by electrophoresis, purified (Qiaquick, Qiagen, Valencia, CA), and subjected to duplicate cycle sequencing reactions using ABI BigDye v3.1 reagents (Applied Biosystems, Carlsbad, CA). Labeled sequencing products were purified for capillary electrophoresis (ABI3730 or ABI3130 sequencer with POP7 polymer), and sequence results were examined using ABI SeqScape software. All nucleotide changes were noted, including 30 single nucleotide polymorphism (SNPs) in the population tested, the most common of which were coding changes at T454A, H2507Q, and G2545R, and silent change at nucleotide t2508c.|1 month|||participants|||Number
78517|NCT01016067|Secondary|"Number of Subjects Having Additional Surgical Procedure Classified as a Treatment Failure"|Subject who had a surgery after the original study treatment was classified as a treatment “failure” if the additional surgery or treatment occurred in the involved limb and affected the study treatment and/or its mechanism of action in relation to the diagnosis or condition of the subject that was the cause for having the original study treatment.|12 months|||participants|||Number
78518|NCT01016067|Secondary|Success in Short Form 36-Item (SF-36) Health Survey|SF-36 was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success was defined as any improvement in a subject’s SF-36 PCS post-operatively as compared to the pre-operative condition.|12 months|||participants|||Number
78519|NCT01016067|Secondary|Success in Short Musculoskeletal Functional Assessment (SMFA)|The SMFA is an assessment tool that measures a subject’s overall function for a broad range of musculoskeletal injuries and disorders. The SMFA results were summarized into two components, the dysfunctional index and the bother index. Success for the SMFA assessment was defined as any improvement post-operatively as compared to the pre-operative condition.|12 months|||participants|||Number
78520|NCT01016067|Secondary|Success of Pain Status at the Delayed Healing Site|After walking five or six steps, subjects rated their intensity of pain/discomfort at the delayed healing site using a numerical rating scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be”. Subjects who were unable or declined to walk because of severe leg pain were considered to have a score of 10. Success for pain at the delayed healing site was defined as at least a 2-point improvement in pain from the pre-operative score. Success of pain status at the delayed healing site was a component of overall success.|12 months|||participants|||Number
78521|NCT01016067|Secondary|Success in Weight Bearing Ability|Success in weight bearing ability (a component of overall success) was defined that subject was able to bear weight without severe pain on the affected limb. The subject was asked to stand, bearing full weight on the affected limb in a single-leg stance without ambulatory assistance for 10 seconds. If the subject was able to do so without severe pain, a positive (success) response was recorded. If the subject was either unable to stand on the affected limb in a single-leg stance or declined to do so because of limb weakness, poor balance, or severe leg pain, a negative (failure) response was documented.|12 months|||participants|||Number
78522|NCT01016067|Secondary|Radiographic Union Success|Radiographic union success (a component of overall success) was defined as complete disappearance of fracture lines or the presence of bridging bone across the delayed healing site as observed on at least three of the four cortices (anterior, posterior, medial, and lateral), using plain films. If there was more than one delayed healing fracture line, all fracture lines must have been united in order to be considered a successful fracture union.|12 months|||participants|||Number
78523|NCT01016067|Primary|Overall Success|Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as “implant-associated” or “implant/surgical procedure-associated” (device-related); 5.no additional surgical procedures classified as a failure.|12 Months|"Ten investigational and 9 control subjects were evaluable for overall success while only 9 investigational and 8 control subjects completed the study at 12-month follow-up. Two subjects were classified as failure due to related serious adverse event or additional surgery before completion of the study."||participants|||Number
78524|NCT01016015|Primary|Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks|||participants|||Number
78525|NCT01015976|Primary|AUC Post Surgery (n =5) Compared to AUC Control (n=5)|AUC of surgery group compared to the AUC of control group|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours|Per protocol||ng-hr/mL||Standard Deviation|Mean
78526|NCT01015820|Primary|Mean Blood Vessel Radius (BVR)|BVR serves as a marker for early increase of blood supply (EIBS).|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.||cm||95% Confidence Interval|Mean
78527|NCT01015820|Primary|Deoxyhemoglobin Concentration (DHb)|Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.||alpha units||95% Confidence Interval|Mean
78528|NCT01015781|Primary|Tinnitus Functional Index Change Score|"The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for “responsiveness” (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change.~Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores:~<25 = relatively mild tinnitus (little or no need for intervention)~25-50 = significant problems with tinnitus (possible need for intervention) •>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful."|Baseline, 6 months (from Baseline)|"The analysis was intention to treat (ITT). Includes all subjects from whom both baseline and 6 month data were collected."||units on a scale||Standard Deviation|Mean
78529|NCT01015703|Primary|Safety Events|Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.|Duration of study|||percentage of patients|||Number
78530|NCT01015677|Secondary|Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4|FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERα activity and a pharmacodynamic endpoint).|Baseline and Week 4|The Per-Protocol (PP) population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.||mIU/mL||90% Confidence Interval|Least Squares Mean
78634|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 8|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||L/hour||Standard Deviation|Mean
78531|NCT01015677|Secondary|Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4|Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.||Percent change||95% Confidence Interval|Least Squares Mean
78532|NCT01015677|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The APaT population is all participants who received at least one dose of study drug.||Participants|||Number
78533|NCT01015677|Primary|Number of Participants Who Experienced at Least One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 6 weeks|The All-Patients-as Treated (APaT) population is all participants who received at least one dose of study drug.||Participants|||Number
78534|NCT01015677|Primary|Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4|Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.||Percent change||95% Confidence Interval|Least Squares Mean
78535|NCT01015638|Secondary|Subject Assessment - Oiliness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
78536|NCT01015638|Secondary|Subject Assessment - Blistering|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
78537|NCT01015638|Secondary|Subject Assessment - Crusting|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
78538|NCT01015638|Secondary|Subject Assessment - Pain|"At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.~Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here."|2 Weeks|||units on a scale||Standard Deviation|Mean
78539|NCT01015638|Secondary|Subject Assessment - Roughness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here."|2 weeks|||units on a scale||Standard Deviation|Mean
78540|NCT01015638|Secondary|Subject Assessment - Dryness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here."|2 weeks|||units on a scale||Standard Deviation|Mean
78708|NCT01013753|Secondary|Potassium 3 Hours Post-dose|Effect on potassium evaluated 3 hours post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set||mmol/L||95% Confidence Interval|Geometric Mean
78541|NCT01015638|Secondary|Subject Tolerability - Stinging|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None,1 – Slight,2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here."|2 weeks|||units on a scale||Standard Deviation|Mean
78542|NCT01015638|Secondary|Subject Tolerability - Burning|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here."|2 weeks|ITT||units on a scale||Standard Deviation|Mean
78543|NCT01015638|Secondary|Changes in the Skin Surface Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|14 days|ITT||microsiemens||Standard Deviation|Mean
78544|NCT01015638|Primary|Skin Dryness|"Visual Dryness was evaluated using the following scale:~Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring"|14 days|ITT||units on a scale||Standard Deviation|Mean
78545|NCT01015638|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration."|14 days|||grams/m^2/hour||Standard Deviation|Mean
78546|NCT01015638|Primary|Erythema (Redness)|"Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.~Erythema (redness) was evaluated using the following scale:~Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion"|14 days|ITT||units on a scale||Standard Deviation|Mean
78547|NCT01015560|Primary|uNTX Response Rate at 43 Days|Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.|43 days|Eligible and analyzable patients||percentage of participants||95% Confidence Interval|Number
78548|NCT01015534|Secondary|Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.|"AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0~Grade 3 Severe AE.~Grade 4 Life-threatening or disabling AE."|4 months|Participants were assessed with a Complete blood count at the end of the first and second weeks of treatment. A standard biochemical profile was performed at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Participants also were evaluated clinically with the same periodicity .||Events|||Number
78549|NCT01015534|Secondary|Overall Survival|Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.|1 year|Data on all enrolled participants were included in an intention-to-treat analysis.||Months of Overall Survival||95% Confidence Interval|Median
78550|NCT01015534|Secondary|Survival Free of Brain Metastases Progression (PFS of BM)|Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.|at 90 days|Data on all enrolled participants were included in an intention-to-treat analysis.||Percentage of Participants||95% Confidence Interval|Number
78551|NCT01015534|Primary|Objective Response Rates. Assessed With Cranial MRI|"Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.~Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants."|90 days|Data on all enrolled participants were included in an intention-to-treat analysis.||Percentage of participants with OR||95% Confidence Interval|Number
78552|NCT01015443|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented.|From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years|Safety analysis set included all subjects who received at least one dose of trial treatment.||Subjects|||Number
78709|NCT01013753|Secondary|Potassium 1 Hour Post-dose|Effect on potassium evaluated 1 hour post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set||mmol/L||95% Confidence Interval|Geometric Mean
78553|NCT01015443|Secondary|Time to Treatment Failure (TTF)|TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment.|From the date of randomization to the date of first missed treatment, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
78554|NCT01015443|Secondary|Progression Free Survival (PFS)|Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging.|From the date of randomization to PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
78555|NCT01015443|Secondary|Time to Progression (TTP)|Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up.|From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
78556|NCT01015443|Secondary|Time to Symptom Progression (TTSP)|TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation.|From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
78557|NCT01015443|Primary|Overall Survival (OS) Time|OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis.|From the date of randomization until death, assessed up to 5.6 years|The modified intent-to-treat (mITT) analysis set was based on the intention-to-treat (ITT) analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.||Months||95% Confidence Interval|Median
78558|NCT01015326|Primary|Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)|"Patients were asked How important is this symptoms or concern to your quality of life? They were given a series of items (listed in the table) and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. Experts were asked How important is this symptom or concern to patients' quality of life? They were given the same series of items and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. For each item, a mean score was calculated using the values assigned to that item from all patients, and a second mean score was calculated using the values assigned to that item from all experts. An item's mean score may range from 0 to 3, where 0 is equivalent to not at all important to quality of life and where 3 is equivalent to extremely important to quality of life."|at time of questionnaire|Additional items that were variably collected and recorded have been omitted from the data set.||units on a scale||Standard Deviation|Mean
78559|NCT01015287|Other Pre-specified|Summary of All-Cause Death|All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.|Randomization through 30 days|All randomized participants who received at least 1 dose of study drug.||participants|||Number
78710|NCT01013753|Secondary|Potassium 1 Hour Pre-dose|Effect on potassium evaluated 1 hour pre-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set||mmol/L||95% Confidence Interval|Geometric Mean
78560|NCT01015287|Secondary|Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78561|NCT01015287|Secondary|Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)|Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.|Baseline, before PCI (not greater than 48 hours after randomization)|All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization).||ratio of assayed troponin/ULN||Standard Error|Least Squares Mean
78562|NCT01015287|Secondary|Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78563|NCT01015287|Secondary|Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)|ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78564|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78565|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78566|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78567|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78568|NCT01015287|Secondary|Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78569|NCT01015287|Primary|The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout|The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
78570|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmean measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
78571|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmax measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
78572|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmax determined at the end of Cycle 1 of chemotherapy.||Correlation coefficient||90% Confidence Interval|Number
78573|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmean determined at the end of Cycle 1 of chemotherapy.||Correlation coefficient||90% Confidence Interval|Number
78574|NCT01015131|Primary|Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNB) are obtained after completing imaging studies at baseline and approximately 2 to 3 weeks later, after the first cycle of chemotherapy. These tissue samples are then used to measure expression of the cell proliferation marker Ki-67, by manually counting percentage positive immunostained cells, denoted the labeling index (LI).|Baseline and up to 3 weeks|Participants whose Ki-67 Labeling Index were measured at Baseline and after 1 cycle of chemotherapy||Labeling Index||Standard Deviation|Mean
78575|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of tissue radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmax measures the maximum radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy||SUV||Standard Deviation|Mean
78576|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their Ki-67 LI measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
78577|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their PSS measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy||Correlation coefficient||90% Confidence Interval|Number
78578|NCT01015131|Secondary|Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|MRI of participants was used to measure tumor volumes at baseline and after completing chemotherapy, after approximately 11 to 30 weeks of treatment.|Baseline and up to 30 weeks|Participants who had tumors measured by MRI at Baseline and at the end of chemotherapy||cm^3||Standard Deviation|Mean
78579|NCT01015131|Secondary|Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNBs) obtained at baseline and after approximately 2-3 weeks of treatment, at the end of the first cycle of chemotherapy, are used to measure cell proliferation by a Proliferation Signature Score (PSS). PSS is calculated from the messenger RNA (mRNA) expression of 47 genes that negatively correlate with time to recurrence, and involves taking their average normalized scores. For reference, a database of 16,000 tumors gave a minimum PSS of 1.51 and a maximum PSS of 2.89; where a higher PSS is associated with an increase in proliferation, higher tumor grade and worse outcomes.|Baseline and up to 3 weeks|Participants who had PSS determined at Baseline and after 1 cycle of chemotherapy||Proliferation Score||Standard Deviation|Mean
78580|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy||SUV||Standard Deviation|Mean
78616|NCT01014442|Primary|Free Fraction of Free MPA at Day 90|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
78617|NCT01014442|Primary|Free Fraction of Free MPA at Day 20|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
78581|NCT01015118|Secondary|Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.|"Change in Global Health Status/ QoL over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.~As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).~Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until data cut-off 29Apr2013, upto 41 months|Randomised Set (RS) for patients with global health status/QoL||units on a scale||Standard Error|Mean
78582|NCT01015118|Secondary|Change in Abdominal/Gastro-intestinal Symptoms Over Time|"Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).~As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).~Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until data cut-off 29Apr2013, upto 41 months|Randomised Set (RS) for patients with abdominal/gastro-intestinal symptoms||units on a scale||Standard Error|Mean
78583|NCT01015118|Secondary|Objective Response Based on Investigator Assessment|Objective tumour response defined as either complete response [CR] or partial response [PR] in patients with at least 1 target lesion reported at baseline|First drug administration until data cut-off 29Apr2013, upto 41 months|Randomised Set (RS) for patients with at least 1 target lesion reported at baseline||percentage of participants|||Number
78584|NCT01015118|Secondary|Time to CA-125 Tumour Marker Progression|Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 >=2 x nadir in case nadir value > ULN or CA-125 >=2 x ULN in case nadir value <= ULN.|First drug administration until data cut-off 29Apr2013, upto 41 months|Randomised set (RS)||Months||Inter-Quartile Range|Median
78585|NCT01015118|Secondary|Overall Survival|"Overall survival is defined as time from randomization until death.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.~This study is ongoing, thus overall survival data is immature at this stage of primary analysis."|First drug administration until data cut-off 29Apr2013, upto 41 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
78586|NCT01015118|Secondary|PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint)|"Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first, upto 29 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
78587|NCT01015118|Primary|PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.|"Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first, upto 29 months|Randomised Set (RS)||Months||Inter-Quartile Range|Median
78588|NCT01014975|Primary|Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort||90 days|Safety Population||participants|||Number
78589|NCT01014910|Secondary|Clinical Deterioration Necessitating Transfer to Higher Level of Care||Summarized from admission to hospital discharge|||participants|||Number
78590|NCT01014910|Primary|Length of Stay in the Hospital||Summarized from admission to hospital discharge|||hours||Inter-Quartile Range|Median
78591|NCT01014871|Primary|Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead|Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.|5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5|Intention To Treat||Scores on a scale||Standard Deviation|Mean
78592|NCT01014728|Secondary|Surgeon’s Numeric Rating Scale (SNRS)|The surgeon’s numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.||units on a scale||Full Range|Median
78593|NCT01014728|Secondary|Anesthesiologist Numeric Rating Scale (ANRS)|The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.||units on a scale||Full Range|Median
78594|NCT01014728|Primary|Estimated Blood Loss|Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.|from the start of surgery to the end of surgery, up to 6 hours|||mL/h||Standard Deviation|Mean
78595|NCT01014689|Secondary|Success Rate on the Investigator’s Global Assessment (IGA) at Week 12|Percentage of Subjects “Clear” or “Almost Clear” on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12.|Baseline and Week 12|Intention To treat - Last Observation Carried Forward||percent of subjects|||Number
78596|NCT01014689|Primary|Percent Change From Baseline in Total Lesion Count|Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.|Baseline and Week 12|Intention to treat - Last observation carried forward||percent of change||Full Range|Median
78597|NCT01014624|Secondary|Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose.|Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to R-to-B PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to R-to-B PRU derived from: Number days to R-to-B PRU=-3.350+0.079*PI(1)+0.014*baseline PRU.|up to 12 days after the last dose|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). The primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units.||days to return to baseline PRU|||Number
78598|NCT01014624|Secondary|Percentage of Platelet Inhibition on Washout Day 1|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|Washout Day 1|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3).||Percentage||Standard Deviation|Mean
78599|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%|up to 12 days after the last dose|Subjects in Responder Pop. using secondary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Responder Pop. was primary pop. excluding poor pharmacodynamic responders. Secondary definition of R-to-B was (Baseline PRU-PRU)/ (Baseline PRU) <= 20%||day50%, 75%, 90% returned to baseline|||Number
78600|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Responder Pop. using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at baseline and Washout Day 1. Responder Pop. was Primary Pop. excluding poor pharmacodynamic responders. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units||day 50%, 75%, 90% returned to baseline|||Number
78601|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using secondary definition of return to baseline. Primary Population included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%||day 50%, 75%, 90% returned to baseline|||Number
78602|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using primary definition of return to baseline. Primary population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units||day 50%, 75%, 90% returned to baseline|||Number
78603|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline.|On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|up to 12 days after last dose|Subjects in Primary Pop. using secondary definition of return to baseline. Primary Population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%||cumulative percent returned to baseline|||Number
78618|NCT01014442|Primary|Free Fraction of Free MPA at Day 8|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
79210|NCT01008722|Primary|Survival Free of Atrial Fibrillation|Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds.|6 -12 months|||participants|||Number
78604|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of subjects.|up to 12 days after last dose|Subjects in Primary Population (Pop.) using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units.||cumulative percentage of subjects|||Number
78605|NCT01014585|Secondary|Time to Worsening in Multidimensional Assessment of Fatigue (MAF)|Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.||Days||95% Confidence Interval|Median
78606|NCT01014585|Secondary|Time to Worsening in Patient Global Impression of Change (PGIC)|"Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse."|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.||Days||95% Confidence Interval|Median
78607|NCT01014585|Primary|Time to Loss of Therapeutic Response (LTR)|Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.||Days||95% Confidence Interval|Median
78608|NCT01014455|Primary|Exhaled CO Level Measured Immediately Prior to Surgery|On the morning of surgery, as matter of clinical routine all patients receiving surgery requiring anesthesia services at one of the two main surgical facilities at Mayo Clinic Rochester and who self-report as a current smoker are asked about their typical cigarette consumption (cigarettes per day), if they have smoked cigarettes today, and have their exhaled CO levels measured (Micro Smokerlyzer; Bedfont, United Kingdom). This information is entered into the clinical record. The CO monitors are maintained by the Division of Respiratory Therapy, including regular calibration.|The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.|5 participants did not complete CO measures and were excluded from the analysis of primary outcome||ppm||Standard Deviation|Mean
78609|NCT01014455|Primary|Preoperative Carbon Monoxide Levels||the morning of surgery||||||
78610|NCT01014442|Secondary|Percentage of Participants With Opportunistic Infections|Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens.|Up to Day 90|Safety Population||percentage of participants|||Number
78611|NCT01014442|Secondary|Change From Baseline in T-Cell Phenotype|Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152.|Baseline, Days 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||percentage of lymphocytes||Standard Deviation|Mean
78612|NCT01014442|Secondary|Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels|iATP was expressed in ng/mL.|Baseline, Days 4, 8, 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||ng/mL||Standard Deviation|Mean
78613|NCT01014442|Secondary|Forced Vital Capacity (FVC) at Day 90 Post-Transplantation|FVC at Day 90 post-transplantation is reported.|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for the outcome measure.||L||Standard Deviation|Mean
78614|NCT01014442|Secondary|Percent of Predicted FEV1 at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100%|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for this outcome measure.||percentage of predicted FEV1||Standard Deviation|Mean
78615|NCT01014442|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 90 post-transplantation|ITT Population (total 64 participants). Here, Number of participants analyzed = participants evaluable for this outcome measure.||L||Standard Deviation|Mean
78619|NCT01014442|Primary|Free Fraction of Free MPA at Day 4|MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||percentage of free fraction||Standard Deviation|Mean
78620|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
78621|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
78622|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
78623|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours/L||Standard Deviation|Mean
78624|NCT01014442|Primary|AUC0-12 of Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
78625|NCT01014442|Primary|AUC0-12 of Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
78626|NCT01014442|Primary|AUC0-12 of Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
78627|NCT01014442|Primary|AUC0-12 of Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*mcg/L||Standard Deviation|Mean
78628|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hours*(mg/L)||Standard Deviation|Mean
78629|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*(mg/L)||Standard Deviation|Mean
78630|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*(mg/L)||Standard Deviation|Mean
78631|NCT01014442|Primary|Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||hours*(mg/L)||Standard Deviation|Mean
78632|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 90|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||L/hour||Standard Deviation|Mean
78633|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 20|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||L/hour||Standard Deviation|Mean
78635|NCT01014442|Primary|Clearance (CL) of MPA, MPAG and AcMPAG at Day 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||L/hours||Standard Deviation|Mean
78636|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 90|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
78637|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 20|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
78638|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 8|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
78639|NCT01014442|Primary|Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||Liter||Standard Deviation|Mean
78640|NCT01014442|Primary|Cmin of Free MPA at Day 90|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78641|NCT01014442|Primary|Cmin of Free MPA at Day 20|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78642|NCT01014442|Primary|Cmin of Free MPA at Day 8|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78643|NCT01014442|Primary|Cmin of Free MPA at Day 4|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78644|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 90|Cmin was expressed in mg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
78645|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 20|Cmin was expressed in mg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
78646|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 8|Cmin was expressed in mg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
78647|NCT01014442|Primary|Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4|Cmin was expressed in mg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||mg/L||Standard Deviation|Mean
78648|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
78649|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
78650|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
78651|NCT01014442|Primary|Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||hour||Standard Deviation|Mean
79612|NCT01004770|Primary|Blood Urea Nitrogen and Creatinine Serum Values|Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.|Baseline and up to and including 72 hours post contrast administration|Per Study Protocol||mg/dL||Standard Deviation|Mean
78652|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
78653|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
78654|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
78655|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4|Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.||1/L||Standard Deviation|Mean
78656|NCT01014442|Primary|Cmax of Free MPA at Day 90|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78657|NCT01014442|Primary|Cmax of Free MPA at Day 20|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78658|NCT01014442|Primary|Cmax of Free MPA at Day 8|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78659|NCT01014442|Primary|Cmax of Free MPA at Day 4|Cmax was expressed in micrograms per liter (mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mcg/L||Standard Deviation|Mean
78660|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 90|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
78661|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 20|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
78662|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 8|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
78663|NCT01014442|Primary|Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4|Cmax was expressed in milligrams per liter (mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation|Per Protocol (PP) Population: Intent-to treat (ITT) population (received at least one dose of study drug and where the primary variable was measured at least once under study drug) excluding participants with major protocol violations (total 46 participants). Number of participants analyzed=participants who were evaluable for this outcome measure.||mg/L||Standard Deviation|Mean
78664|NCT01014351|Secondary|Objective Response Rate (ORR)|Objective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||percentage of patients|||Number
78665|NCT01014351|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from randomization until death from any cause.|18 months|||Months||95% Confidence Interval|Median
78666|NCT01014351|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|||Months||95% Confidence Interval|Median
78667|NCT01014208|Secondary|Time to Engraftment After High-dose Therapy (HDT)/ASCT|Engraftment is defined as 1) three consecutive days when the ANC is ≥0.5x109/L and 2) an unsupported platelet count of ≥20x109/L, and the engraftment date is the date that this occurs. If engraftment was not achieved by Day 42 or the last observation, engraftment was deemed to be a failure, and censoring took place at Day 42 or at the last observation.|From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months)|Safety population. Only participants completing HDT/ASCT are included.||Days||95% Confidence Interval|Median
78711|NCT01013753|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 4-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.||units on a scale||Standard Error|Mean
78668|NCT01014208|Secondary|Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy|Neutrophil (absolute neutrophil count [ANC]) recovery is defined as ANC >=0.5*10^9/Liter and increasing, and platelet (PLT) recovery is defined as PLT >=10*10^9/Liter and increasing. For each cycle, time to ANC recovery is defined as the time from the first dose to the first ANC >=0.5*10^9/Liter and increasing after the nadir in the cycle. For each cycle, time to PLT recovery is defined as the time from the first dose to the first PLT >=10*10^9/L and increasing after the nadir in the cycle.|From the start of each cycle for a maximum of 5 weeks per cycle (assessed during treatment period of Baseline up to approximately 3 months)|Safety Population. Only those participants available for analysis in the given cycle were assessed.||days||95% Confidence Interval|Median
78669|NCT01014208|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment|"The FACT-Lym TOI is a measure that combines the FACT-Lym subscale (15 items; responses to each item range from 0, Not at all to 4, Very much) with two domains taken from the FACT-G (responses to each item range from Not at all  to Very much): Physical Well-being (7 items: lack of energy, nausea, meeting family needs, pain, side effects, feels ill, spends time in bed) and Functional Well-being (7 items: ability to work, work fulfilment, ability to enjoy life, illness acceptance, ability to sleep well, enjoying things done for fun, satisfaction with quality of life). This index is designed to be sensitive to changes in treatment regimens. The total FACT-Lym TOI score ranges from 0 to 116; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.||scores on a scale||Standard Error|Mean
78670|NCT01014208|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment|"The FACT-G was developed by the Functional Assessment of Chronic Illness Therapy (FACIT) group for use in adults in a wide range of oncology clinical trial populations. The 27 items of the FACT-G are scored in the following domains: Physical Well-being (7 items), Social/Family Wellbeing (7 items), Emotional Well-being (6 items), and Functional Well-being (7 items). Participants responded to the items on a five-point Likert scale ranging from 0, Not at all to 4, Very much. The total score ranges from 0 to 108; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.||scores on a scale||Standard Error|Mean
78671|NCT01014208|Secondary|Number of Participants Completing Autologous Stem Cell Transplant (ASCT)|The number of participants who completed ASCT is reported.|Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months)|ITT Population||Participants|||Number
78672|NCT01014208|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood|Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization is defined as the collection of >2*10^6 CD34+ cells/kg. Only those participants, who commenced harvest, following the administration of rituximab or ofatumumab in combination with DHAP combination chemotherapy, were assessed. The number of participants with adequate harvest of CD34+ stem cells (at least 2*10^6 CD34+ cells/kg) after dosing of salvage therapy in Cycle 2 and Cycle 3 was analyzed.|During Cycles 2 and/or 3 (Weeks 4-9)|ITT Population. Only participants commencing leukapheresis are included.||Participants|||Number
78673|NCT01014208|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death due to any cause. Participants who were still alive by the end of the study were censored.|From randomization to death due to any cause (assessed for up to 5 years)|ITT Population||Months||95% Confidence Interval|Median
78674|NCT01014208|Secondary|Event-free Survival|Event-free survival is defined as the time from randomization to progressive disease (PD; disease whose course is growth, or spread of the disease), stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for PD) after completion of 2 cycles of therapy, commencement of a new treatment for diffuse large B cell lymphoma (DLBCL) (e.g., radiotherapy), or death from any cause, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization to progressive disease, stable disease after completion of 2 cycles of therapy, commencement of a new treatment for DLBCL, or death due to any cause (assessed for up to 5 years)|ITT Population||Months||95% Confidence Interval|Median
78675|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months)|ITT Population. Only participants completing HDT/ASCT are included.||Participants|||Number
78676|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks)|ITT Population||Participants|||Number
78712|NCT01013753|Secondary|Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ (s)) at the end of each 4 week treatment period. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.||units on a scale||Standard Error|Mean
78677|NCT01014208|Primary|Progression-free Survival as Assessed by Independent Reviewers|Progression-free survival is defined as the interval of time from the randomization date until the date of stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for progressive disease [PD]) after two cycles of salvage chemotherapy, progression, or death, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)|Intent-to-Treat (ITT) Population: all participants who were randomized and commenced study therapy (at least one dose of a study drug)||Months||95% Confidence Interval|Median
78678|NCT01014169|Secondary|Maternal Practice Related to Correct Car Seat Use|Correct car seat use by all subjects who use cars was defined as placing the car seat in the back seat facing backwards and using the car seat every time the infant travels by car. The number reported is the number who report using the car seat correctly.|two days after discharge|||participants with correct car seat use|||Number
78679|NCT01014169|Secondary|Maternal Practice Related to Breastfeeding Initiation|This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.|two days after discharge|||participants who report breastfeeding|||Number
78680|NCT01014169|Primary|The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.|This measure assesses maternal report of placing the infant on the back to sleep (supine sleep position) as opposed to putting the infant on its side or stomach.|two days after discharge|||participants who report supine position|||Number
78681|NCT01014143|Primary|Plaque Index|Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Four days|per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.||Units on a scale||Standard Deviation|Mean
78682|NCT01014013|Secondary|Clinical Response Assessment Profile|The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Secondary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)||Participants|||Number
78683|NCT01014013|Primary|The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment|Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.|Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days|Safety Analysis has been done 267 patients who received at least 1 dose of parenteral therapy (132 patients from MK0826 and 135 patients from Ceftriaxone)||Participants|||Number
78684|NCT01014013|Primary|Microbiological Response Assessment Profile|The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Primary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)||Participants|||Number
78685|NCT01013961|Secondary|Duration of Response|Duration of response is defined to be time from first confirmed CR, PR or clinical CR to progression or to death without documentation of progression. Patients without confirmed CR, PR or clinical CR are censored at time 0. Those without documentation of progression are censored at the date of last disease assessment without progression, unless death occurs within three months following the date last known progression free.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
78686|NCT01013961|Secondary|Time to Response|Time to response is defined to be time from randomization to first confirmed CR, PR or clinical CR. Those without confirmed CR, PR or clinical CR are censored at the date of last disease assessment.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
78687|NCT01013961|Secondary|Progression-free Survival (PFS)|"PFS is defined to be time from randomization to progression (PD) or to death without documentation of progression. For patients without PD, follow-up is censored at the date of last disease assessment without PD, unless death occurs within three months following the date last known progression free.~PD is characterized by at least one of the following:~≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart (at least 1 node must be >2 cm). Appearance of new palpable lymph nodes (>1 cm in diameter).~≥50% increase in the size of liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly which was not previously present.~Absolute number of circulating lymphocytes with a count of >5x10^9/L~Transformation to a more aggressive histology"|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
78688|NCT01013961|Secondary|Overall Survival (OS)|OS is defined to be time from randomization to death from any cause. Those still alive are censored at the date of last contact.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients||months||95% Confidence Interval|Median
78713|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of patients|||Number
78714|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of patients|||Number
78689|NCT01013961|Primary|Proportion of Patients With Overall Response (OR)|"OR is defined as either CR, clinical CR, or partial response (PR) evaluated by NCI-WG96 criteria. CR has been defined in the other primary endpoint.~A clinical CR requires all of the following:~Absence of lymphadenopathy by physical examination~No hepatomegaly or splenomegaly. Spleen and/or liver, if considered enlarged at baseline, should not be palpable, due to disease, on physical exam~Absence of constitutional symptoms~Normal CBC as exhibited by:~A PR requires all the following for ≥2 months:~≥50% decrease in peripheral blood lymphocyte count from baseline~≥50% reduction in lymphadenopathy~≥50% reduction in size of liver and/or spleen~Polymorphonuclear leukocytes ≥1.5x10^9/L or 50% improvement over baseline~Platelets >100x10^9/L or 50% improvement over baseline~Hemoglobin >11.0 gm/dl or 50% improvement over baseline without transfusions~Any constitutional symptoms"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients||proportion of participants||95% Confidence Interval|Number
78690|NCT01013961|Primary|Proportion of Patients With Complete Response (CR)|"Response was evaluated using NCI-WG96 criteria.~A CR requires all of the following for >= 2 months:~Absence of lymphadenopathy > 1 cm in diameter by physical examination~No hepatomegaly or splenomegaly on physical exam~No constitutional symptoms~Normal complete blood count (CBC)~Patients achieving a clinical CR with negative CT scan after 2 cycles of therapy are re-evaluated using immunohistochemical examination of bone marrow biopsy for residual CLL cells. Patients with no evidence of residual disease and no radiological evidence of residual CLL on CT scan of chest-abdomen-pelvis and no clinical evidence of CLL on clinical evaluation after completion of 2 cycles of therapy will be considered to have a CR with no evidence of residual disease"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients||proportion of participants||95% Confidence Interval|Number
78691|NCT01013883|Secondary|Admission to Hospital for Any Cause|Number of patients admitted to the hospital will be recorded|During the follow up period of 7 years|||participants|||Number
78692|NCT01013883|Secondary|Cardiovascular Mortality||Patients would be followed up for average of 7years|||participants|||Number
78693|NCT01013883|Primary|All Cause Mortality||Patients would be followed up for average of 7 years|||participants|||Number
78694|NCT01013870|Secondary|Symbol Digit Modalities Test - Written Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78695|NCT01013870|Secondary|Symbol Digit Modalities Test - Oral Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78696|NCT01013870|Secondary|Brief Visuospatial Memory Test - Revised|The BVMT-R is a measure of visuospatial memory. Six equivalent, alternate stimulus forms consist of six geometric figures printed in a 2 x 3 array on separate pages. In three Learning Trials, the subject views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Scoring of the immediate and delayed recall are based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78697|NCT01013870|Secondary|Center for Epidemiological Study Depression Scale|The CES-D is a widely used screening scale for depression, assessing depressive feelings and behaviors occurring in the past week of a patient’s life. The CES-D consists of 20 items, which make up six scales reflecting depressive symptomatology: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Each item is scored on a 4-point scale ranging from 0 (rarely/none of the time) to 3 (most/all of the time). Scores for items 4, 8, 12, and 16 are reversed before summing all items to yield a total score, which can range from 0-60. Higher scores indicate more depressive symptoms. (Radloff, LS [1977]. The CES-D Scale: A self-report depression scale for research in the general population. App Psychol Meas, 1, 385-401.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78715|NCT01013753|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of patients|||Number
78698|NCT01013870|Secondary|Connor Davidson Resilience Measure|The Connor-Davidson Resilience scale (CD-RISC) has 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. The sum score has a range from 0 to 100. (Conner KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale [CD-RISC]. Depress Anxiety 18[2]:76-82,2003].|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78699|NCT01013870|Secondary|Post-traumatic Stress Checklist - Civilian Form|The Post Traumatic Stress Disorder Checklist (PCL) is a 17-item self report measure of the DSM-IV symptoms of PTSD. Respondents rate how much they were “bothered by a symptom” on a 5-point scale ranging from 1 (“not at all”) to 5 (“extremely”). The PCL was scored as a total score (range 17-85), with higher total scores indicating more symptoms. (Weathers, F., Litz, B., Herman, D., Huska, J., & Keane, T. [October 1993]. The PTSD Checklist [PCL]: Reliability, Validity, and Diagnostic Utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78700|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Physical Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78701|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Mental Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Inter-Quartile Range|Median
78702|NCT01013870|Primary|Rivermead Post-Concussion Symptoms Questionnaire, at 3 Months After Injury.|The Rivermead Post-Concussive Symptoms Questionnaire (RPQ) is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms found in the literature. The scale compares any current symptoms to pre-injury symptom levels to account for potential symptom exacerbation due to TBI. The range of scores is 0-64. Values for each of the 16 items include 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), 4 (severe problem). The total score was a summation of symptoms that represented new symptom onset or an exacerbation of a symptom present pre-injury. (King, N.S., Crawford, S., Wenden, F.J., Moss, N.E., & Wade, D.T. [1995]. The Rivermead Post Concussion Symptoms Questionnaire: A Measure of Symptoms Commonly Experiences after Head Injury and its Reliability. Journal of Neurology 242: 587-92.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).||units on a scale||Full Range|Median
78703|NCT01013844|Primary|Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.|4 months|||Number of times reviewed SSE guidelines||Standard Deviation|Mean
78704|NCT01013844|Primary|Mean Number of Skin Examinations With Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.|4 months|||Times examined skin with a partner||Standard Deviation|Mean
78705|NCT01013844|Primary|Mean Number of Skin Examinations Without Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.|4 months|||Times examined skin by self||Standard Deviation|Mean
78706|NCT01013792|Primary|Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit|A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.|up to 8 weeks|All participants that are randomized||percent change of baseline area||Full Range|Median
78707|NCT01013753|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|4 weeks|Treated Set||Participants|||Number
78716|NCT01013753|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days after the first 2 weeks of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM2+ device.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Percentage of asthma symptom free days||Standard Error|Mean
78717|NCT01013753|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Number of Puffs||Standard Error|Mean
78718|NCT01013753|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||L||Standard Error|Mean
78719|NCT01013753|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||L||Standard Error|Mean
78720|NCT01013753|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Percentage||Standard Error|Mean
78721|NCT01013753|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Liter/min||Standard Error|Mean
78722|NCT01013753|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.||Liter/min||Standard Error|Mean
78723|NCT01013753|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
78724|NCT01013753|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post-dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
78725|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
78726|NCT01013753|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
78727|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS||Liter/sec||Standard Error|Mean
78807|NCT01012414|Secondary|Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A||1 year|Data were not collected when study was stopped prematurely.|||||
78808|NCT01012414|Primary|Change in High Sensitivity-C Reactive Protein (Serum)||1 year|Data were not collected when study was stopped prematurely.|||||
78728|NCT01013753|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78729|NCT01013753|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post dose measured following the trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78730|NCT01013753|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78731|NCT01013753|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78732|NCT01013753|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78733|NCT01013753|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78734|NCT01013753|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78735|NCT01013753|Secondary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78736|NCT01013753|Secondary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS||Liter||Standard Error|Mean
78737|NCT01013753|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.||Liter||Standard Error|Mean
78809|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|6 months|||participants|||Number
78738|NCT01013740|Secondary|Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE.|From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)|Safety Population: participants who received at least one dose of study medication, based on the actual treatment received||participants|||Number
78739|NCT01013740|Secondary|Maximum Concentration (Cmax) for Vinorelbine|Cmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose||||||
78740|NCT01013740|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC-tau) for Vinorelbine|AUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose||||||
78741|NCT01013740|Secondary|Number of Participants With Clinical Benefit (CB) in the Randomized Phase|CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population||participants|||Number
78742|NCT01013740|Secondary|Time to Response in the Randomized Phase|Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for time to response.||weeks||95% Confidence Interval|Median
78743|NCT01013740|Secondary|Duration of Response (DOR) in the Randomized Phase|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.||months||95% Confidence Interval|Median
78744|NCT01013740|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From the date of randomization until death (average of 55 study weeks)|ITT Population||months||95% Confidence Interval|Median
78745|NCT01013740|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population||participants|||Number
78746|NCT01013740|Primary|Progression Free Survival (PFS) in the Randomized Phase|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population: participants who were randomized to study treatment, regardless of whether they actually received study medication||months||95% Confidence Interval|Median
78747|NCT01013597|Secondary|Tolerability of LBH589|Tolerability and toxicity were not assessed separately, therefore tolerability is reported as toxicity.|Every 4 weeks.||||||
78748|NCT01013597|Secondary|Toxicity of LBH589|Most frequent toxicities at least possibly related to panobinostat, grades 2-4 (grading based on NCI common terminology criteria for adverse events CTCAE version 3). Toxicities were collected from the time the patient provided informed consent until 4 weeks after the patient stopped LBH589.|Every 4 weeks from consent through 4 weeks after end of study treatment|||participants|||Number
78749|NCT01013597|Secondary|Impact of LBH589 on Tumor Markers for Thyroid Cancer|Change in serum Thyroglobulin level from baseline to end of treatment. Treatment continued until either extraordinary medical circumstances, disease progression, toxicity, subject withdrawal, or death. At the time subjects came off of study treatment for one of the reasons already listed, a sample was collected for tumor markers.|Baseline and end of treament|||ng/mL||Standard Deviation|Mean
78750|NCT01013597|Secondary|Overall Survival|For a given patient, overall survival (OS) is defined as the number of days from the day of first LBH589 administration until the patient’s death. If a patient was alive at the time of analysis, then the patient’s data is censored at the date of the last available evaluation.Survival was assessed every three months until death or final data analysis, whichever occurred first..|Every 3 months|||months||95% Confidence Interval|Median
78751|NCT01013597|Secondary|Time to Progression of Thyroid Cancer|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is defined as the number of days from the day of first LBH589 administration to the day the patient experienced an event of disease progression or death, whichever came first. Progression was assessed every 3 months until death or up to 5 years, whichever occurred first.|Every 3 months until progression up to 5 years|||months||95% Confidence Interval|Median
78752|NCT01013597|Secondary|Protein Expression Patterns of Notch1 in Thyroid Tissue Samples.||End of study|Notch1 protein expression was not measured due to lack of efficiency of study intervention|||||
78753|NCT01013597|Primary|Tumor Response Rate to LBH589.|"per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT/MRI: Response includes Complete Response (CR, disappearance of all target lesions), or Partial Response (PR, >=30% decrease in the sum of the longest diameter of target lesions). No Response includes Stable Disease (SD, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease), and Progressive Disease (PD, at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).)"|Every 8 weeks.|||participants|||Number
78754|NCT01013207|Secondary|Usability of the Nexus (S9) CPAP.|The usability quesitonnaire was administered at the end of the 4 week trial of Nexus (S9). Usability was defined as ease of using the Nexus (S9) and overall satisfaction with the Nexus (S9) CPAP. The outcome measure was collected through 11 point Likert questionnaires, where 0 = very poor usability and 10 = excellent usability.|4 weeks|||Units on a scale||Standard Deviation|Mean
78755|NCT01013207|Primary|Compliance on CPAP|Compliance on CPAP was measured as average daily usage|12 weeks|||Hours||Standard Deviation|Mean
78756|NCT01013194|Secondary|Analysis of Meld Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Meld score.~The Model for End-stage Liver Disease (MELD) scoring system aims at stratifying recipients by their disease severity according to a score estimating the 3-month probability of death on the waiting list. The calculation of an individual’s MELD score is based on three objective lab parameters (bilirubin, serum creatinine and prothrombin time expressed as international normalized ratio, INR) and it includes logarithmic transformations and multiplication by several factors. It ranges between 6 and 40. The highest is the score the lower is the patient’s survival."|Baseline and 1 year Follow-up|||units on a scale||Standard Deviation|Mean
78757|NCT01013194|Secondary|Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Child-Pugh score.~The Child-Pugh (CP) classification is a scoring system used for the classification of the severity of cirrhosis. It includes three continuous variables (bilirubin, albumin and INR) and two discrete variables (ascites and encephalopathy). Each variable is scored 1-3 with 3 indicating most severe derangement. The determination of CP score may range from 5 to 15 and the final score allows to categorize patients in Child–Pugh A (5–6 points), B (7–9 points) and C (10–15 points). The highest is the score the sickest is the patient."|Baseline and 1 year Follow-up|Baseline Child-Pugh score vs Follow-up||units on a scale||Standard Deviation|Mean
78758|NCT01013194|Primary|Patient Survival|Assessment of treated and control patients survival at 1 year follow-up|1 year|||participants|||Number
78759|NCT01012973|Secondary|Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||Scores on a scale||Standard Deviation|Mean
78760|NCT01012973|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||Scores on a scale||Standard Deviation|Mean
78761|NCT01012973|Secondary|Percentage of Participants Who Developed Neovascularization During the First 24 Weeks|Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24|From baseline until Week 24|Full analysis set||Percentage of participants|||Number
78762|NCT01012973|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||microns||Standard Deviation|Mean
78763|NCT01012973|Secondary|Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.|Baseline and Week 24|Full analysis set||Letters correctly read||Standard Deviation|Mean
78764|NCT01012973|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline and Week 24|Full analysis set||Percentage of participants|||Number
78810|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|3 months|||Participants|||Number
78811|NCT01012336|Secondary|Time to First Vomiting Episode or Use of Rescue Medication||120 hours||||||
78765|NCT01012947|Primary|Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group|"The mini–mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It ranges from 0 to 30 points. The higher scores mean better outcome. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment.~In the time span of about 10 minutes it samples various functions including arithmetic, memory and orientation."|baseline and 18 months|The location of the survey was Suwon City, with a population of 1 million, located adjacent to Seoul, the nation's capital. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.||units on a scale||Standard Deviation|Mean
78766|NCT01012765|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 20 days were included in the analysis.||Liters||95% Confidence Interval|Least Squares Mean
78767|NCT01012765|Secondary|FEV1 30 Minutes Post-dose After 21 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.||Liters||95% Confidence Interval|Least Squares Mean
78768|NCT01012765|Secondary|Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment|Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.||kPa*sec||95% Confidence Interval|Least Squares Mean
78769|NCT01012765|Secondary|Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment|Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.||Ratio||95% Confidence Interval|Least Squares Mean
78770|NCT01012765|Secondary|Peak Total Lung Capacity (TLC) After 21 Days of Treatment|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.||Liters||95% Confidence Interval|Least Squares Mean
78771|NCT01012765|Secondary|Peak Residual Volume (RV) After 21 Days of Treatment|Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.||Liters||95% Confidence Interval|Least Squares Mean
78772|NCT01012765|Secondary|Trough IC After 20 Days of Treatment|Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 20 days were included in this analysis.||Liters||95% Confidence Interval|Least Squares Mean
78773|NCT01012765|Primary|Peak Inspiratory Capacity (IC) After 21 Days of Treatment|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.||Liters||95% Confidence Interval|Least Squares Mean
78774|NCT01012739|Secondary|Indacaterol Exposure (Cmax) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.||pg/mL||Standard Deviation|Mean
78812|NCT01012336|Secondary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy||120 hours||||||
78775|NCT01012739|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.||pg*hr/mL||Standard Deviation|Mean
78776|NCT01012739|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|From 5 minutes to 4 hours post-dose for each treatment|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||Standard Deviation|Mean
78777|NCT01012739|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|From 5 minutes to 12 hours post-dose|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Hours||Standard Deviation|Mean
78778|NCT01012739|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||Standard Deviation|Mean
78779|NCT01012739|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||Standard Deviation|Mean
78780|NCT01012713|Secondary|A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.||12 weeks|||percent||95% Confidence Interval|Number
78781|NCT01012713|Secondary|The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.||8 weeks|||percent||95% Confidence Interval|Number
78782|NCT01012713|Primary|The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.||12 weeks|||percent||95% Confidence Interval|Number
78783|NCT01012674|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2 - 42 days|||percentage of arterial segments|Participants|95% Confidence Interval|Number
78784|NCT01012674|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2-42 days|||percentage of arterial segments|Participants|95% Confidence Interval|Number
78785|NCT01012674|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).|2 - 28 days|||percentage of arterial segments|Participants|95% Confidence Interval|Number
78786|NCT01012661|Primary|Patients With Clinically Significant Reduction in Pain|Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with >/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)|||Participants|||Number
78787|NCT01012661|Primary|Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)|Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)|||cm||Standard Deviation|Mean
78788|NCT01012622|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Improved very much, Improved much and Improved a little are defined as improvement and No change, Aggravated a little, Aggravated much and Aggravated very much were defined as aggravation.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||participants|||Number
78789|NCT01012622|Secondary|Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used.||units on a scale||Standard Deviation|Mean
78813|NCT01012336|Primary|Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen||120 hours||||||
78790|NCT01012622|Secondary|Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12|Parenting Stress Index (PSI) was designed to assess parent or guardian child-rearing stress index on a 5-rating scale from ”never” to “very truly”. Out of 30 items, 20 items are scored, being consisted of 8 child characteristics-related stress items; 9 parent-child interaction-related stress items; and 3 achievement expectation-related stress items. A possible total score ranges from 20 to 100; Increase in score indicates higher stress perceived by the parent.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78791|NCT01012622|Secondary|Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12|Beck Depression Inventory (BDI) consisted of 21 items for measuring the subjective severity of depression and emotional, cognitive, motivational, physiological symptoms of depression. Each question has a set of 4 possible answer choices, ranging in intensity, each answer being scored on a scale value of 0 (no symptom) to 3 (the most severe symptom). Accordingly, the total score ranges from 0 (no symptom) to 63 (the most severe symptom) for 21 questions.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78792|NCT01012622|Secondary|Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12|APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78793|NCT01012622|Secondary|Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the backward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||correct responses||Standard Deviation|Mean
78794|NCT01012622|Secondary|Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the forward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||correct responses||Standard Deviation|Mean
78795|NCT01012622|Secondary|Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple divided attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78796|NCT01012622|Secondary|Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple interference-selective attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78814|NCT01012336|Primary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.|Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).|120 hours|||Percentage of Participants|||Number
78797|NCT01012622|Secondary|Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple inhibition-sustained attention in terms of omission(number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78798|NCT01012622|Secondary|Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple auditory selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78799|NCT01012622|Secondary|Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple visual selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
78800|NCT01012622|Secondary|Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12|CHIP was designed to assess the physical, psychological health conditions and functional well-being of children. The instrument has sub-domains such satisfaction (11 items) ranges from 0 to 44, stability (22 items) ranges from 0 to 88, elasticity (19 items) ranges from 0 to 76, risk aversion (14 items) ranges from 0 to 56, achievement (10 items) ranges from 0 to 40. Good health is in the range from 44 to 56 points for all sub-domains. A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The total score is an average of the scores for the 5 domains and ranges from 0 to 304. Higher total score indicates better health.|Baseline and Week 12|"ITT population included participants who took study drug at least once and had primary efficacy endpoint data available. Last Observation Carried Forward (LOCF) method was used. n signifies participants who were evaluated for each specified category for this measure."||units on a scale||Standard Deviation|Mean
78801|NCT01012622|Primary|Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression – Improvement (CGI-I) Scale Score at Week 12|Remission is defined by all of the following criteria; 1) K-ARS Total score of 18 or less. 2) “Very much improved” or “Much improved” in CGI-I. K-ARS total score ranges from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. CGI-I is a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse, higher score indicates worsening of condition.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||participants|||Number
78802|NCT01012622|Primary|Number of Participants With Response Based on K-ARS Total Score at Week 12|Response is defined as at least 25 percent (%) decrease in total score of K-ARS compared to baseline. K-ARS measures the 18 symptoms based on DSM-IV (1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.||participants|||Number
78803|NCT01012622|Primary|Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12|K-ARS measures the 18 symptoms based on Diagnostic and Statistical Manual of Mental Disorders-forth edition (DSM-IV 1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Baseline and Week 12|Intention-to-treat (ITT) population included participants who received the study drug at least once and had the primary efficacy endpoint data available||units on a scale||Standard Deviation|Mean
78804|NCT01012440|Primary|Reduction in Tumor Size|Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.|1-2 weeks post treatment onset|This study has been terminated due to poor accrual.||mm||Standard Deviation|Mean
78805|NCT01012414|Secondary|Effect on Carotid Intima-media Thickening (CIMT)||1 year|Data were not collected when study was stopped prematurely.|||||
78806|NCT01012414|Secondary|Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.||1 year|Data were not collected when study was stopped prematurely.|||||
78815|NCT01012258|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the duration (in months) from first administration of trial treatment to first observation of PD (radiological or clinical, if radiological PD is not available), or death due to any cause. The PFS time of participants without observation of PD but death occurring after two or more missed consecutive tumor assessments (i.e. two-fold scheduled time interval of two consecutive tumor assessments) was censored on the date of last tumor assessment or first administration of trial treatment (whichever was later).|Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant|ITT population included all participants who received at least one dose of the IMP cetuximab or RT.||months||95% Confidence Interval|Median
78816|NCT01012258|Primary|Best Overall Response (BOR)|Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit|Intention-to-treat (ITT) population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or RT.||percentage of participants||95% Confidence Interval|Number
78817|NCT01012245|Secondary|Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment|Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.|Baseline up to 3 years|Xalatan® treatment group (subjects with Xalatan® (latanoprost) monotherapy at baseline visit) and Xalacom® treatment group (latanoprost + timolol maleate) therapy at baseline visit. During the course of the study the data structure (scaling of color) was changed in a way that change in iris color was no longer evaluable; data not summarized.||participants|||Number
78818|NCT01012245|Secondary|Reasons for Discontinuation From Study|Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.|January 2000 through December 2008|Subjects from the All subjects group population who discontinued the study.||participants|||Number
78819|NCT01012245|Secondary|Investigator Assessment of Tolerability of Xalatan® Treatment|Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.|Baseline up to 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).||participants|||Number
78820|NCT01012245|Secondary|Reasons for Changes in Glaucoma Therapy|Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.|January 2000 through December 2008|"Subjects from the all subjects group that changed therapy through the duration of the study; subjects who changed from or changed to other therapy (Other Medication) were not included in this analysis; not summarized by subgroups."||participants|||Number
78821|NCT01012245|Secondary|Subject Self-care: Application of Eye Drops|Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups||participants|||Number
78822|NCT01012245|Secondary|Visual Impairment Due to Glaucoma|Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups||participants|||Number
78823|NCT01012245|Secondary|Visual Acuity (Visus)|Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations||participants|||Number
78824|NCT01012245|Secondary|Subject Assessment of Satisfaction With Xalatan® Treatment|Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).||participants|||Number
78825|NCT01012245|Secondary|Investigator Assessment of Xalatan® Efficacy|Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan® monotherapy at baseline visit).||participants|||Number
78826|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.||ratio||Standard Deviation|Mean
78892|NCT01011556|Secondary|Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels|Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).|Baseline and 1, 3, 12, and 13 Months (mon)|All randomized participants who received at least one dose of study drug and had antibody results.||participants|||Number
78827|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.||ratio||Standard Deviation|Mean
78828|NCT01012245|Primary|Aulhorn Stage (Visual Field Defects)|Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations||participants|||Number
78829|NCT01012245|Primary|Change From Baseline in Intraocular Pressure (IOP)|Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).|Baseline, 1 year, 2 years, and 3 years|All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.||mm Hg||Standard Deviation|Mean
78830|NCT01012219|Primary|Cutaneous Bleeding Time (BT)|"Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.~The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.~Period 3 was not analyzed as bleeding time was not an objective for this part of the study."|Day 8|Due to technical reasons, bleeding time was zero for some participants; they were considered to be missing data. Therefore, these observations were excluded from the analysis.||Seconds||95% Confidence Interval|Least Squares Mean
78831|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 6.5%||percentage of participants|||Number
78832|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 7.0%||percentage of participants|||Number
78833|NCT01012037|Secondary|Percentage of Patients With Rescue Therapy|Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.|12 weeks|||percent|||Number
78834|NCT01012037|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12|Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.|Week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Patients without a value at Week 12 were analysed as non-responders||percent|||Number
78835|NCT01012037|Secondary|FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.||percent||Standard Error|Mean
78836|NCT01012037|Secondary|FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.||percent||Standard Error|Mean
78837|NCT01012037|Secondary|FPG Change From Baseline at Week 12|Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Mean
78838|NCT01012037|Secondary|HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.||percent||Standard Error|Mean
78839|NCT01012037|Secondary|HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 6 value were handled by the statistical model.||percent||Standard Error|Mean
78893|NCT01011556|Secondary|Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).||Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position.||beats per minute (bpm)||Standard Deviation|Mean
78840|NCT01012037|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Mean
78841|NCT01011946|Primary|Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer|Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as “normal” or “abnormal”. Lymph Node (LN) sampling and histopathology determined true positives and true negatives.|PEM was performed prior to surgery and LN sampling immediately following surgery|||percentage of subjects||95% Confidence Interval|Number
78842|NCT01011933|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry.|Study entry up to 2 years|||participants|||Number
78843|NCT01011933|Other Pre-specified|Reason Off Study Therapy||from study entry until end of study treatment|||participants|||Number
78844|NCT01011933|Secondary|Duration of Overall Survival||Up to 5 years||||||
78845|NCT01011933|Secondary|Duration of Progression-free Survival||Up to 5 years||||||
78846|NCT01011933|Primary|Frequency and Severity of Adverse Effects as Assessed by CTCAE v3.0||Up to 5 years||||||
78847|NCT01011933|Primary|Objective Tumor Response Rate Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at study entry, is required; Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry; Stable Disease is any condition not meeting the above criteria.|From study entry, assessed up to 5 years|||participants|||Number
78848|NCT01011933|Primary|Number of Participants With or Without Progression-free Survival for > 6 Months by Response Evaluation Criteria for Solid Tumors (RECIST)|"Number of participants who survived progression-free for more than 6 months.~Progression is defined using Response Evaluation Criteria for Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions in the opinion of the treating physician, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression."|> 6 months from study entry|||participants|||Number
78849|NCT01011907|Secondary|Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.|Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.|Week 1 to Week 12|||Scores on a scale||Standard Error|Mean
78850|NCT01011907|Secondary|Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.||Weeks 1-12|||drinks||Standard Error|Mean
78851|NCT01011907|Primary|Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.||Weeks 1-12|||cigarettes||Standard Error|Mean
78852|NCT01011868|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment|The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% After 18, 54, and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (NCF)||participants|||Number
78853|NCT01011868|Other Pre-specified|Confirmed Hypoglycemic Events|Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as ‘Hypoglycaemic event’ in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia).|During the course of the study (82 weeks)|Treated set (TS). Treatment assignment as first medication taken.||participants|||Number
78854|NCT01011868|Secondary|Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment|Change from baseline in HbA1c after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|Week 54 - FAS (OC-78) Week 78 - FAS78-completers (LOCF-78)||percentage of HbA1c||Standard Error|Mean
78855|NCT01011868|Secondary|Change From Baseline in Body Weight at Follow-up|Change from baseline in body weight at follow up (82 weeks)|Baseline and 82 weeks|FAS-FU (OR)||kg||Standard Deviation|Mean
78856|NCT01011868|Secondary|Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment|Change from baseline in body weight after 18, 54 and 78 weeks of treatment|Baseline, 18, 54, 78 weeks|FAS (OC)||kg||Standard Error|Mean
78857|NCT01011868|Secondary|Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment|Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|FAS (OC-78) for week 54 FAS78-completers (LOCF-78) for week 78 - Values after start of antidiabetic rescue therapy except changes in basal insulin dose were set to missing and last observation carried forward (LOCF) was used for imputation of missing values||IU||Standard Error|Mean
78858|NCT01011868|Secondary|Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (OC)||percentage of Change from BL in FPG||Standard Error|Mean
78859|NCT01011868|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS observed cases (OC)||mg/dL||Standard Error|Mean
78860|NCT01011868|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment|Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment|Baseline and 18, 54 and 78 weeks|FAS with non-completers considered failure (NCF)||participants|||Number
78861|NCT01011868|Primary|Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment|Baseline and 18 weeks|"FAS18-completers-included FAS patients not prematurely discontinue prior to Week 18, completed required minimum treatment duration, and had an on treatment HbA1c value within Week 18 time window. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF-18) was used for imputation.~(LOCF-18)"||percentage of HbA1c||Standard Error|Mean
78862|NCT01011829|Secondary|Retention (Completion)|Retention was determined by the proportion of participants retained for the entire trial and time until drop-out.|8-weeks|Intention to treat||participants|||Number
78863|NCT01011829|Primary|Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|8-weeks|Intention to treat||total MA-free urine drug screens|Participants|Standard Deviation|Mean
78864|NCT01011816|Secondary|Roland-Morris Disability Questionnaire Score|"Percent of subjects achieving a minimum 30% decrease in Roland-Morris Disability Questionnaire score~The Roland-Morris Disability Questionnaire is a widely studied and frequently used instrument for the assessment of function and disability related to low back pain. The questionnaire consists of 24 statements related to how a subject’s back condition affects various activities of daily living. Subjects marked whether the statement either applied to them or did not apply at the time they responded to the statements. The score is the total number of questions with which the subject agreed. A higher score indicates less function and greater disability."|26-weeks|All subjects assigned as success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).||percentage of subjects|||Number
78865|NCT01011816|Secondary|Visual Analog Scale for Low Back Pain|"Percent of subjects achieving a minimum 30% decrease in pain from baseline.~The visual analog scale is a horizontal 100 mm line anchored on the left with the words “No Pain” and on the right with the words “Worst Possible Pain”. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the subject to indicate the subject’s level of low back pain experienced over the last week."|26-weeks|All subjects assigned success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).||percentage of subjects|||Number
78866|NCT01011816|Primary|Subject Composite Success|Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.|26 weeks|All subjects adjudicated as a success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).||percentage of subjects|||Number
78867|NCT01011738|Secondary|Number of Deaths During Observation Period|The clinical endpoint of deaths due to any cause during observation period is presented.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of peginterferon alfa-2a and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
78868|NCT01011738|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Events (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
78869|NCT01011738|Secondary|Number of Participants With Non-Serious Adverse Drug Reactions|Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
78870|NCT01011738|Secondary|Number of Participants With Serious Adverse Drug Reactions|"A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect."|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).||Participants|||Number
78871|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis|Number of participants with clinical endpoints associated with CHB captured in the medical record, where data available, are reported. The clinical endpoints included development of cirrhosis (in participants without cirrhosis at baseline). The liver cirrhosis assessments were summarized from Week 12 to 3 years post-treatment.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Participants|||Number
79027|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after start of intervention/|This was an intent to treat analysis.||% change in grams/cm||Standard Deviation|Mean
78872|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation|Number of clinical endpoints associated with CHB reported in the medical record, where data available, are reported. The clinical endpoints included liver transplantation, hepatocellular carcinoma, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline).|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Participants|||Number
78873|NCT01011738|Secondary|Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status|ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Ratio||Standard Deviation|Mean
78874|NCT01011738|Secondary|Percentage of Participants With Normalization of Alanine Transaminase|A participant was considered to have achieved normalization of alanine transaminase (ALT) if the ALT measurement was lower or equal to the upper limit of the normal range. Only patients with elevated ALT at baseline were included in any analyses where normalization of ALT was used as endpoint. It was analyzed as last serum ALT in the analyzed time window, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
78875|NCT01011738|Secondary|Quantitative Hepatitis B Surface Antigen|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic hepatitis B participants. Last approved quantitative HBsAg measurement in the analyzed time window.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Log10 IU/mL||Standard Deviation|Mean
78876|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion|Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection. A participant was considered to have achieved HBsAg seroconversion if (a) the participant achieved HBsAg clearance and (b) the last approved anti-HBs measurement in the analyzed time window was reported as i) ‘POSITIVE’ or (ii) quantitative result and was greater than or equal to the reported lower limit of detection.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
78877|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants|The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
78878|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants|"A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. If a patient received NUCs after end of PEG IFN treatment, then a reported suppression of HBV DNA to < 2,000 IU/mL during or after this NUC treatment were to be ignored, and HBV DNA ≥ 2,000 IU/mL was to be assigned. However, HBV DNA < 2,000 IU/mL was not to be ignored, if the NUC treatment given parallel to PEG IFN was discontinued within the first 8 weeks after end of PEG IFN treatment and prior to the HBV DNA value concerned no further NUCs were administered.~Abbreviations for Seroconversion=sercnvrsn, Analysis A= AnalysA, and Analysis B= AnalysB, pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
78879|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants|A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) ‘NEGATIVE’ or (b) a quantitative result was lower than the reported lower detection limit. This endpoint was measured in the participants with HBeAg positive CHB.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
78894|NCT01011556|Secondary|Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.|Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position.||mmHg||Standard Deviation|Mean
78895|NCT01011556|Secondary|Change From Baseline in Urine Calcium Excretion at 6 and 12 Months||Baseline, 6 Months, 12 Months|All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint.||millimole/day (mmol/day)||Standard Deviation|Mean
78880|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants|"HBeAg seroconversion is presented as percentage of participants who become HBeAg negative and anti-HBe positive. A participant was considered to have achieved HBeAg seroconversion if (a) the participant achieved HBeAg loss and (b) the anti-HBe measurement was reported as (i) ‘POSITIVE’ or (ii) a quantitative result considered ‘positive’ in the context. HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL: A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL.~Abbreviations for pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
78881|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants|The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
78882|NCT01011738|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.||Percentage of Participants||95% Confidence Interval|Number
78883|NCT01011738|Primary|Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance|Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) ‘Negative’ or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis “as observed”).|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
78884|NCT01011673|Secondary|Satisfaction Scores|"24 hours after the emergency department visit, patients were asked, The next time you come to the Er with this type of headache, do you want to receive the same medication? Affirmative answers are tabulated here."|24 hours|3 patients in each group were lost to follow-up. All others are tabulated here.||participants|||Number
78885|NCT01011673|Primary|Change in Pain Score|At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score|Baseline, 60 minutes|3 randomized patients were not included in this analysis. During the ED visit, these patients were diagnosed with intracranial hemorrhage, brain abscess, and malaria and therefore did not truly have a primary headache disorder. Including these patients, 123 were randomized.||units on a scale||Standard Deviation|Mean
78886|NCT01011634|Primary|Pain Score Within 5 Mins After Procedure||within 5 mins after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.|||||
78887|NCT01011634|Secondary|Acceptability of Pain, Would They Choose the Same Regimen Again for Another Uterine Aspiration||30 min after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.|||||
78888|NCT01011556|Secondary|DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up|Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months.||participants|||Number
78889|NCT01011556|Secondary|DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up|Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months.||participants|||Number
78890|NCT01011556|Secondary|Pharmacokinetics Parameters: Maximal Concentration (Cmax)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, 12 Months|Due to high intra-subject variability, zero participants were analyzed for this outcome measure.|||||
78891|NCT01011556|Secondary|Pharmacokinetics Parameters: Area Under the Curve (AUC)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, and 12 Months|Due to high intra-subject variability, zero participants were analyzed on this outcome measure.|||||
78896|NCT01011556|Secondary|Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours|Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + [(40 - albumin) x 0.02]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).|Baseline, 12 Months|All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint.||millimole/Liter (mmol/L)||Standard Deviation|Mean
78897|NCT01011556|Secondary|Convenience/Ease of Use Questionnaire (CEUQ)|CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.|baseline up to 12 months|All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire.||participants|||Number
78898|NCT01011556|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.||percentage change in P1CP||Standard Deviation|Median
78899|NCT01011556|Secondary|Percent Change From Baseline of C-Terminal Telopeptide (CTX)|C-terminal telopeptide is a marker of bone resorption.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.||percentage change in CTX||Standard Deviation|Mean
78900|NCT01011556|Secondary|Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.||percentage change in P1NP||Standard Deviation|Mean
78901|NCT01011556|Secondary|Time Course Change of BMD Response at the Lumbar Spine|To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).|Baseline to 6 Months and 12 Months|All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal.||percentage change in BMD||90% Confidence Interval|Least Squares Mean
78902|NCT01011556|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|Baseline, 6 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model.||percentage change in BMD||90% Confidence Interval|Least Squares Mean
78903|NCT01011556|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.|Baseline, 12 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.||percentage change in BMD||90% Confidence Interval|Least Squares Mean
78904|NCT01011465|Primary|Speech Threat and Challenge|Measure of threat and challenge calculated from observation of non-verbal behavioral cues during stress exposure. Threat (negative reaction) results when an individual does not feel that he or she has sufficient resources to complete a task or manage a difficult situation. Its reverse, challenge (positive reaction), occurs when an individual perceives that he or she has sufficient resources. Independent observers used videotapes of behavior during the stress tasks and rated participants on 7 point scales for 11 challenge-related behaviors (comfortable, confident, enthusiastic, clear, alert, high level of eye contact, etc), and for 8 threat-related behaviors (agitation, rigid posture, speech disfluency, etc). Challenge scores were averaged, and threat scores averaged then reverse-scored. The mean of challenge and reversed threat scores comprise the score used here. Range: 1.1 to 6.1, with higher scores representing more challenge orientation and reflecting a better outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom speech threat score was calculated, were included||units on a scale||Standard Deviation|Mean
78905|NCT01011465|Primary|Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure).|Based on 20-item Positive and Negative Affect Schedule (PANAS) which comprises two mood scales, positive affect and negative affect. Each item is rated on a 5-point scale ranging from (1 = very slightly or not at all) to (5 = extremely) to indicate how the respondent felt at the moment the question was asked. Here, we’ve used the negative affect sub-scale which consists of the sum of the 10 negative affect items, with a possible range of 10 (least negative affect) to 50 (most negative affect). This score was measured at baseline (study range: 10 to 29) and directly before stress exposure (study range: 10 to 37), and the reported value is the difference between these two scores (range of differences: -13 to 26). It estimates negative affect due to anticipatory stress. The value is the difference between the pre-stress measure and baseline measure, therefore a larger number for the difference means a bigger increase in negative affect due to anticipatory stress, and is a worse outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom negative affect score was calculated, were included||units on a scale||Standard Deviation|Mean
79254|NCT01008449|Secondary|Subject Satisfaction With Comfort With Scar|Scar discomfort satisfaction was reported by subject perception using a scale of 1 - 5. A score of 1 would be the worst comfort and a score of 5 would be the best comfort|at end of follow-up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
78906|NCT01011465|Primary|Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure|Systolic blood pressure (SBP)is connected with reaction to exposure to stress. Systolic blood pressure is collected at baseline and after nasal spray administration/directly before stress tasks; it represents anticipatory stress reaction. This measure represents the difference between baseline and pre-task systolic blood pressure values. A greater difference score represents an increase from baseline in systolic blood pressure during the pre-task, and so a larger difference score represents higher reactivity. A lower difference score, or negative difference score, indicates a lower increase, or even decrease, from baseline in systolic blood pressure during the pre-task and reflects less reactivity. Reactivity is associated with increased risk of developing hypertension. Range of baseline/pre-count differences in SBP: -11 to 37.7|within 2 hours of treatment|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom systolic blood pressure was collected, were included||mm Hg||Standard Deviation|Mean
78907|NCT01011387|Primary|Mean Change in Wound Area.|Measured by tracing of wound and measured by planimeter.|From baseline to maximum 4 weeks|||cm2||Full Range|Mean
78908|NCT01011309|Secondary|IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)|Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.|Days 0, 56 or 84, and 168|Per-protocol population: patients who received all three study injections (immunotherapy groups) or at least 15 SSG injections (chemotherapy group) and completed the Day 84 or Day 56 visit.||Relative ELISA Units||Full Range|Median
78909|NCT01011309|Primary|Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.|Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.|Day 0 through Day 84|Safety population: All patients who received at least one study injection.||participants|||Number
78910|NCT01011309|Primary|Date of Clinical Cure|Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.|Day 84|Per-protocol population: All patients who received all three study injections if in the immunotherapy groups or at least 15 injections of SSG if in the chemotherapy group, and completed the Day 56 visit (Immunotherapy v1.6), the Day 84 visit (Immunotherapy v1.4/1.5), or the Day 56 or Day 84 visit (Chemotherapy group).||participants|||Number
78911|NCT01011283|Secondary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.~Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|36 Weeks|Intent to Treat Population||Percentage of Participants|||Number
78912|NCT01011283|Primary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.~Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|13 Weeks|Intent to Treat Population||Percentage of Participants|||Number
78913|NCT01011179|Secondary|Stress (Perceived Stress Questionnaire; PSQ)||Baseline (prior to randomization) and 3 months after intervention||||||
78914|NCT01011179|Secondary|Adherence to Treatment (Child Adherence Report Questionnaire; CARQ)||Baseline (prior to randomization) and 3 months after intervention||||||
78915|NCT01011179|Secondary|Self-efficacy (Children's Arthritis Self-Efficacy Scale; CASE)||Baseline (prior to randomization) and 3 months after intervention||||||
78916|NCT01011179|Secondary|Pain Coping (Pain Coping Questionnaire)||Baseline (prior to randomization) and 3 months after intervention||||||
78917|NCT01011179|Secondary|Disease Specific Knowledge (Medical Issues, Exercise, Pain and Social Support Questionnaire; MEPS)||Baseline (prior to randomization) and 3 months after intervention||||||
78918|NCT01011179|Primary|Juvenile Arthritis Quality of Life Questionnaire (JAQQ)|The questionnaire is divided into 4 dimensions: gross motor function, fine motor function, psychosocial function, and general symptoms. A 7-point ordinal scale is used to rate responses to each item from 1 (none of the time) to 7 (all of the time), based on how often the item was a problem for the child over the past 2 weeks. Total score was composed of the 4 dimension scores (top 5 items of that dimension) divided by 4, with higher scores denoting poorer HRQOL.|Baseline (prior to randomization) and 3 months after intervention|||units on a scale||Standard Deviation|Mean
78919|NCT01011153|Secondary|To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians.|For each case reviewed, physicians were asked if they thought the lesion was a melanoma (diagnostic sensitivity/specificity) and whether or not they would biopsy or refer the lesion (biopsy/referral sensitivity/specificity. These measurements were compared using areas under the corresponding receiver operating characteristic curves. (see statistical analysis for results) ROC curves (reciver operating curves) are plotted on graphs with an x-axis of sensitivity and a y-axis of 1-specificity.|June 2010|||Area Under Curve for biopsy/referral||Standard Deviation|Geometric Mean
79028|NCT01010230|Secondary|Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of µg/L||Standard Deviation|Mean
78920|NCT01011153|Secondary|Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.|Each physician was given up to 130 cases and asked whether or not they would biopsy the lesion. Interobserver variability was measured via the kappa statistic indicating how well the physicians' answers to that question agreed within each group. Kappa statistics are reported in the statistical analysis. while numbers rep, they dont reflect the sgreement among the subjects|December 2009|The statistical analysis section contains the Kappa results within Each of the Caregiver Groups||Number of Cases|||Number
78921|NCT01011153|Secondary|Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of each group of physicians to that of Melafind, which is presented in the statistical analysis.|December 2009|Each category was diminished after excluded subjects were taken into account. These included subjects who did not complete at least 78 cases, subjects who previously participated in other EOS studies, pediatricians, and a board eligible dermatologist.||Proportion of True Cases||95% Confidence Interval|Mean
78922|NCT01011153|Primary|Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.|April 2010|Participants were invited to enroll in this study via mail. Minimum number of participants was determined by statistician based on power analyses and number of cases completed. The time frame of the study was about 6 months and the comparison between Dermatologists and MelaFind is presented in the statistical analysis section below.||Proportion of True Cases||95% Confidence Interval|Mean
78923|NCT01011075|Secondary|Toxicities|Adverse events of grade 3 or higher, according to CTCAE version 3|12 months|All enrolled and treated patients were evaluated for grade 3 or higher toxicities.||Number of events|||Number
78924|NCT01011075|Secondary|Progression Free Survival|Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)|12 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.||Months||95% Confidence Interval|Median
78925|NCT01011075|Secondary|Overall Survival|Overall survival as measured by the Kaplan-Meier method|12 Months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.||Months||95% Confidence Interval|Median
78926|NCT01011075|Primary|Response Rate|Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.|6 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.||Percentage of Participants||95% Confidence Interval|Number
78927|NCT01011049|Secondary|Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per protocol population.||Percentage of Participants|||Number
78928|NCT01011049|Secondary|Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
78929|NCT01011049|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
78930|NCT01011049|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Participants|||Number
78931|NCT01010971|Secondary|Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo.|Week 0-2|||Days||Standard Error|Least Squares Mean
78932|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In Impaired Subjects with Baseline RQLQ(S) Score of ≥3.0||units on a scale||Standard Error|Least Squares Mean
78933|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
78934|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0||participants||Standard Error|Least Squares Mean
78935|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0||participants||Standard Error|Least Squares Mean
78936|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0||units on a scale||Standard Error|Least Squares Mean
78937|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0||units on a scale||Standard Error|Least Squares Mean
78938|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0||units on a scale||Standard Error|Least Squares Mean
78939|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78940|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78941|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78961|NCT01010906|Secondary|Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug.||µM||95% Confidence Interval|Geometric Mean
78942|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78943|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78944|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78945|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
78946|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
78947|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
78948|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
78949|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0||units on a scale||Standard Error|Least Squares Mean
78950|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
79010|NCT01010399|Secondary|Proportion of Subjects With HIV-1 RNA <50 Copies/mL||24 weeks|||participants|||Number
79011|NCT01010399|Primary|Proportion of Subjects With Triglycerides <200 mg/dL||24 weeks|||participants|||Number
78951|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78952|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78953|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78954|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78955|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78956|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
78957|NCT01010971|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.||Units on a scale||Standard Error|Least Squares Mean
78958|NCT01010932|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2 - 42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.||percentage of non-stenotic segments|Participants|95% Confidence Interval|Number
78959|NCT01010932|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2-42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.||percentage of stenotic segments|Participants|95% Confidence Interval|Number
78960|NCT01010932|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).|2 - 28 days|For 2 patients, MRA images were not analyzed because images were incomplete.||percentage of arterial segments|Participants|95% Confidence Interval|Number
79026|NCT01010230|Primary|Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in g/cm^2||Standard Deviation|Mean
78962|NCT01010906|Primary|Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug. AUC for one participant with Mild HI was not estimated due to poor correlation of the linear regression.||µM.hr||95% Confidence Interval|Geometric Mean
78963|NCT01010776|Other Pre-specified|Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13, 26, 39 and 52|The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78964|NCT01010776|Other Pre-specified|Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13 and 26|The safety analysis population included all the participants that received at least one dose of study medication and provided any post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78965|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
78966|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
78967|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase|Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of participants|||Number
78968|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction - Main Phase|Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Percentage of Participants|||Number
78969|NCT01010776|Secondary|Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Extension Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Week 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Participants|||Number
86578|NCT00942786|Other Pre-specified|NT-ProBNP Preoperative|NT-ProBNP was measured 0-24 hours before induction of anesthesia|0-24 hours before induction of anesthesia|Consecutive patients undergoing emergent non-cardiac surgery||pg/ml||Inter-Quartile Range|Median
78970|NCT01010776|Secondary|Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Main Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Participants|||Number
78971|NCT01010776|Secondary|Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78972|NCT01010776|Secondary|Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78973|NCT01010776|Secondary|Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78974|NCT01010776|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78975|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78976|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase|The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
78977|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.||Percentage of participants||95% Confidence Interval|Number
78978|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.||Percentage of participants||95% Confidence Interval|Number
78979|NCT01010776|Primary|Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.||Units on a scale||Standard Deviation|Mean
78980|NCT01010776|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 26|The intent-to-treat for effectiveness (ITTe) population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Last Observation Carried Forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
78981|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index|Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
78982|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Problems With Self-Concept|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
78983|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
78984|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
78985|NCT01010750|Secondary|Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD||Units on a scale||Standard Error|Mean
78986|NCT01010750|Primary|Power of Attention Score|The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.|pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7|The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.||milliseconds||Standard Error|Mean
78987|NCT01010633|Primary|Grade 0 Pain|Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.|Visit 5 (Postoperative Day 8)|Intent to treat population (ITT)||Eyes|Participants||Number
78988|NCT01010633|Secondary|Resolution of Anterior Chamber Cells.|Study eyes with complete resolution of anterior chamber cells (ACC)|At visits 4-7- postoperative day 3, 8,15 & 18|||Eyes|||Number
78989|NCT01010633|Primary|Resolution of Anterior Chamber Cells (ACC).|Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.|Visit 5 (Postoperative day 8)|Intent to treat (ITT) population||Eyes|Participants||Number
78990|NCT01010568|Secondary|Median PFS|Kaplan Meyer PFS|2 years|||months||95% Confidence Interval|Median
78991|NCT01010568|Secondary|Complete Response Rate|NCI IWG response criteria|6 months|||participants|||Number
78992|NCT01010568|Primary|Overall Response Rate|40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia|6 months|||participants|||Number
78993|NCT01010555|Primary|On-eye Wettability|On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.||units on a scale||Standard Deviation|Mean
78994|NCT01010503|Secondary|Short Form-36 (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.|Weeks 0, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
78995|NCT01010503|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
78996|NCT01010503|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase protein. Levels of CRP increase with inflammation.|Weeks 0, 4, 12, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
78997|NCT01010503|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Weeks 0, 4, 12, 20, and 24|TT population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
78998|NCT01010503|Secondary|Tender Joint Count (TJC)|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
78999|NCT01010503|Secondary|Swollen Joint Count (SJC)|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
79000|NCT01010503|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
79001|NCT01010503|Secondary|Patient Global Assessment of Disease Activity|The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
79002|NCT01010503|Secondary|Patient Global Assessment of Pain|Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
79003|NCT01010503|Primary|Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg||Weeks 0, 4, 8, 12, 16, and 20|ITT Population||percentage of participants|||Number
79004|NCT01010503|Primary|Percentage of Participants Withdrawing From the Study Prematurely for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
79005|NCT01010503|Primary|Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
79006|NCT01010503|Primary|Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
79007|NCT01010503|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Weeks 0, 4, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
79008|NCT01010503|Primary|Percentage of Participants Adherent to Original Treatment|Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.|Week 24|Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug||percentage of participants|||Number
79009|NCT01010477|Primary|The Number of Subjects Who Quit Smoking From Weeks 5 to 8|Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.|4 weeks|||participants|||Number
79012|NCT01010282|Secondary|Change From Baseline in Conjunctival Staining Severity Score at Day 90|Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
79013|NCT01010282|Secondary|Change From Baseline in Corneal Staining at Day 90|Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
79014|NCT01010282|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Day 90|Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Seconds||Standard Deviation|Mean
79015|NCT01010282|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90|Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
79016|NCT01010282|Primary|Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90|Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
79017|NCT01010230|Secondary|Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups|"Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index.~Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||ratio of RANKL/OPG||Standard Deviation|Mean
79018|NCT01010230|Secondary|Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of 10 nmol BCE/L||Standard Deviation|Mean
79019|NCT01010230|Secondary|Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of µg/l||Standard Deviation|Mean
79020|NCT01010230|Secondary|Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of µg/L||Standard Deviation|Mean
79021|NCT01010230|Secondary|Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||log of ng/mL||Standard Deviation|Mean
79022|NCT01010230|Primary|Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in mg/cm^4||Standard Deviation|Mean
79023|NCT01010230|Primary|Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in mg/cc||Standard Deviation|Mean
79024|NCT01010230|Primary|Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in mg/cc||Standard Deviation|Mean
79025|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.||% change in g/cm^2||Standard Deviation|Mean
79029|NCT01010230|Primary|Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after start of intervention|This was an intent to treat analysis.||% change in grams/cm||Standard Deviation|Mean
79030|NCT01010204|Primary|7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence|24 weeks|bipolar patients||participants|||Number
79031|NCT01010204|Secondary|Evaluate the Safety of Varenicline in Treatment-emergent Hypomania, Mania, Mixed or Depressed Episodes or Being Associated Suicidal or Aggressive Behavior or Psychotic Symptoms When Used as Adjunctive Treatment in Participants With Bipolar Disorder.||24 weeks||||||
79032|NCT01010204|Primary|7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks|12 weeks|bipolar subjects||participants|||Number
79033|NCT01010061|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.||unit on a scale||Standard Deviation|Mean
79034|NCT01010061|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score|The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.||unit on a scale||Standard Deviation|Mean
79035|NCT01010061|Secondary|Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)|Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).|Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)|PK population includes all participants with PK data available at the given time-point.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
79036|NCT01010061|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.||Months||95% Confidence Interval|Median
79037|NCT01010061|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
79038|NCT01010061|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.||Months||95% Confidence Interval|Median
79039|NCT01010061|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.||Months||95% Confidence Interval|Median
79048|NCT01010009|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|This outcome measure assessed any significant modulation of cognitive task performance during the 46-81 min post dose period. The cognitive tasks utilized were cognitively demanding computer based, numerical tasks which assessed working memory. Significant modulation is defined as significant difference between baseline and post-dose task performance.|46-81 mins post dose|Cognitive performance data was analysed for all subjects who completed the trial. If data was not utilized in the final analysis then this was either due to technical issues (i.e. the computer did not save data) or it was clear that the participant had not engaged with the task/s.||Participants|||Number
79040|NCT01010061|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.||Months||95% Confidence Interval|Median
79041|NCT01010061|Secondary|Percentage of Participants With Best Overall Response|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
79042|NCT01010061|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.||Percentage of participants||95% Confidence Interval|Number
79043|NCT01010061|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff (median observation 14.2 months)|Intent-to-treat population included all randomized participants. Participants without PFS events were censored.||Percentage of participants|||Number
79044|NCT01010061|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 14.2 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.||Months||95% Confidence Interval|Median
79045|NCT01010061|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
79046|NCT01010061|Primary|Progression-free Survival (PFS)|"PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator.~Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L)."|Randomization to clinical cutoff (median observation 42 months from randomization)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.||Months||95% Confidence Interval|Median
79047|NCT01010009|Primary|Modulation of Deoxygenated Levels of Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.||µmol/L||Standard Error|Mean
86865|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose|Average FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|||L||Standard Deviation|Mean
79049|NCT01010009|Primary|Modulation of Levels of Total Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.||µmol/L||Standard Error|Mean
79050|NCT01009983|Secondary|Expression of EGFR and Other Protein Markers||baseline||||||
79051|NCT01009983|Secondary|Survival||monthly||||||
79052|NCT01009983|Secondary|Time to Progression||monthly||||||
79053|NCT01009983|Secondary|Toxicity According to CTCAE v3.0||monthly||||||
79054|NCT01009983|Primary|Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria|Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.|every 28 days for a minimum of 84 days|||participants|||Number
79055|NCT01009931|Secondary|Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression|Cycle 1 of treatment|48 months|The study participant died before the study data collection completed.|||||
79056|NCT01009931|Primary|Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%||43 months|The study participant died before the study data collection completed.|||||
79057|NCT01009931|Primary|Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)||42 months|The study participant died before the study data collection completed.|||||
79058|NCT01009840|Secondary|Percentage of Participants With Hepatic Veno-Occlusive Disease Based on Baltimore Criteria|The Baltimore criteria for veno-occlusive disease was defined as the development of hyperbilirubinemia with serum bilirubin > 2 mg/dl within 21 days after transplantation and at least 2 of the following clinical signs and symptoms: (1) hepatomegaly, usually painful, (2) > 5% weight gain, or (3) ascites.|6 Months|Safety population included all participants who received IV busulfan.||Percentage of participants|||Number
79059|NCT01009840|Secondary|Percentage of Participants With Transplant-Related Mortality|The percentage of participants with death related to transplant.|6 Months|Safety population included all participants who received IV busulfan.||Percentage of participants|||Number
79060|NCT01009840|Secondary|Percent Difference Between Area Under Curve (AUC) and Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percent difference||Full Range|Median
79061|NCT01009840|Secondary|Ratio Area Under Curve (AUC)/Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. Gas chromatography with mass selective detection (GC-MS) was used to determine the busulfan level in plasma. The ratio was calculated: AUC/Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Ratio||Full Range|Median
79062|NCT01009840|Secondary|Percent Change in IV Busulfan Dose|The percent change in dose is relative to the busulfan dose administered at the Baseline Visit (Day -12 to -9) when a dose of 0.8 mg/kg was administered and on Day −5 when the Seattle Cancer Care Alliance recommended PK-adjusted dose was administered.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percent change||Full Range|Median
79063|NCT01009840|Secondary|Percentage of Participants With Progression-free Survival Events|Progression-free survival events are death or first recurrence of progressive disease by International Myeloma Working Group Criteria.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percentage of participants|||Number
79064|NCT01009840|Secondary|Progression-free Survival|Progression-free Survival (PFS) defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease (PD) by IMWG criteria. PD was defined as an Increase of ≥25% from the lowest response value in any one or more of the following: 1)Serum M-component and/or (the absolute increase must be ≥0.5 g/dL), 2)Urine M-component and/or (the absolute increase must be ≥200 mg/24 hr), 3)In patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL, 4)Bone marrow plasma cell percentage; the absolute percentage must be ≥10%, 5)Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas and/or 6)Development of hypercalcaemia that can be attributed solely to the plasma cell proliferative diso|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Days||95% Confidence Interval|Median
79065|NCT01009840|Secondary|Percentage of Participants With Overall Survival Events|Overall Survival Event was death.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percentage of participants|||Number
79066|NCT01009840|Secondary|Overall Survival|Overall Survival was defined as the time in days from transplantation to death due to all causes.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Days||95% Confidence Interval|Median
79255|NCT01008449|Secondary|Subject Reported Satisfaction With Appearance of Scar|Subject reported satisfaction of the scar appearance was assessed by using a scale of 1 - 5 with 1 being worst appearance and 5 being best appearance|4 - 6 weeks post delivery|||units on a scale||Inter-Quartile Range|Median
86866|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h|||L||Standard Deviation|Mean
79067|NCT01009840|Primary|Percentage of Participants With Overall Disease Response at Month 6|The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: [stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow], [Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow], [Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level <100 mg/24 hour], [Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to <200 mg per 24 hour], [Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease] or [Progressive Disease (PD)].|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.||Percentage of participants|||Number
79068|NCT01009762|Secondary|Numbers of Participants With Lowering of HIV RNA Viral-load|"HIV-1 RNA Viral load was measured by Quantitative-PCR in plasma as numbers of virus RNA copies/mm^3 relative to baseline viral-load for each participant. The numbers of participant with lowering of HIV RNA plasma Viral-load is counted at base-line and at 6 months (end of study) and provided in the table (analysis population description) and the number of participants that showed lowering of viral-load was counted.~Criteria for this anticipated end-point was a significant lowering of HIV RNA viral-load in >50% of responders (defined as participants with new T-cell responses)."|up to 6 months after treatment stop|the numbers of participants that showed changes (lowering of) in Viral load (measured as HIV-1 RNA copies/mm^3 plasma in commercial quantitative PCR) at end of study (6 months after vaccination) relative to base-line viral-load was counted at 6 month after vaccination (end of study)||participants|||Number
79069|NCT01009762|Secondary|Number of Participants With New T Cell Response to the Vaccine Target Epitopes|"Number of Participants with New T Cell Response to the Vaccine Target Epitopes as Measured by Intracellular Cytokine Stain Flowcytometry (IC-FACS) and/or IFNg-ELISPOT Analysis.~Criteria's for meeting anticipated secondary end-point was that >50% of vaccinees reacted with new Clusters of differentiation 8 (CD8) T-cell and/or Clusters of differentiation 4 (CD4) T-cell response to al least one of the vaccine target epitopes as measured by IC-Facs and/or interferon-gamma (IFNg) - Enzyme-Linked ImmunoSpot (ELISPOT) assays."|10-14 days or 3 months or 6 months after last immunisation|Peripheral Blood Mononuclear Cells (PBMC) from blood was measured in IFNg-ELISPOT and/or Intracellular Cytokines (ICS) Flowcytometry for T cell responses. All 10 vaccinee developed a new T cell immune response to at least one vaccine epitope. The saline placebo did not develop any new t cell responses.||participants|||Number
79070|NCT01009762|Primary|Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More)|the numbers of treatment related side effects (DLT = reaction 3 or more) are registered for participants|up to 6 months after end of treatment|Interview, questionaire, objective examination by medical doctor, blood testing for hematology, clinical chemistry, CD4 counts, HIV-1 viral load||side effects|||Number
79071|NCT01009645|Secondary|Recall Accuracy|"Participants were given 8 statements about the flu/flu shot and asked to recall if they had seen the statement on the message they received via FedEx. Participants responded that statement had been presented as a fact, presented as a myth, presented, but I don't recall if it was a fact or a myth, or not presented. Participants scored 1 for each correct answer; 0 for each incorrect answer or for response I don't recall. Recall accuracy was calculated among each message format, range for recall accuracy was 0 - 8 with 0 indicating no correct answers and 8 representing 100% accuracy. Thus units of measurement are units on a scale to represent participant scores out of 8 on the recall items."|1 week following receipt of message|||units on a scale||Standard Deviation|Mean
79072|NCT01009645|Primary|Influenza Vaccination|The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.|1 week following randomization|||participants|||Number
79073|NCT01009619|Secondary|Plasma C-reactive Protein (CRP) Levels|Plasma C-reactive protein (CRP) levels were assessed using Tina-quant CRP latex assay, Roche, Mannheim, Germany; sensitivity threshold of 1 mg/L, upper limit of normal 5 mg/L.|during the first two years post-transplant|||mg/L||Standard Deviation|Mean
79074|NCT01009619|Secondary|Broncho-alveolar (BAL) Neutrophilia|BAL was performed with two 50 mL aliquots of sterile saline at room temperature. Five mL of the recovered BAL fluid was sent for microbiological and virological assessment, whereas the remaining fluid was analysed for cell counts after a cytospin was made in a Shandon cytocentrifuge and stained with May-Grünwald-Giemsa. Differential cell counts were determined by counting at least 300 cells.|during first two years post-transplant|||percent cells||Standard Deviation|Mean
79075|NCT01009619|Secondary|Pulmonary Function|Spirometry (Masterscreen, Jaeger, Hoechberg, Germany) was performed at twice weekly intervals for the first 2 postoperative months, thereafter at weekly to biweekly intervals until 6 months post-transplantation, then every 2 to 4 weeks until the first postoperative year and afterwards life-long at intervals of 2 to 3 months according to American Thoracic Society standards and forced expiratory volume in one second (FEV1) expressed in terms of the percentage of predicted values.|during first two years post-transplant|||percent predicted||Standard Deviation|Mean
79076|NCT01009619|Secondary|Infection Incidence Rate|Cytomegalovirus (CMV)-status was assessed on on every broncho-alevolar lavage sample and by serum CMV DNA at weekly intervals during hospitalization and thereafter at each outpatient evaluation or hospital admission. Immunohistochemical staining for CMV was performed on transbronchial biopsies in case of clinical suspicion of infection (i.e. dyspnea, cough, sputum, fever, increased plasma C-reactive protein, new chest radiograph infiltrates, or a decrease of at least 10% in peak expiratory flow (PEF) as measured by patient’s peak flow measurements.|2 years post-transplant|intention to treat||incidence rate (events/person per year)||Standard Deviation|Mean
79256|NCT01008449|Secondary|Post Operative Pain - 72 - 96 Hours Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|72 - 96 hours post delivery|||units on a scale||Inter-Quartile Range|Median
79077|NCT01009619|Secondary|Acute Rejection Incidence Rate|Bronchoscopy and broncho-alveolar lavage (BAL) was routinely performed at discharge, 3, 6, 12, 18, 24 months post-transplantation and later at intervals of 1 year, or in case of clinically suspected acute allograft rejection, infection or chronic rejection. Transbronchial biopsies were routinely performed at discharge and 3 months post-transplant or in case of suspected acute rejection, infection or chronic rejection. Biopsies were graded according to the 1996 ISHLT-guidelines (grade A0-4 with concomitant B0-4), as well as assessed for other interstitial lesions of the pulmonary graft.|2 years post-transplant|||incidence rate (events/person per year)||Standard Deviation|Mean
79078|NCT01009619|Primary|Overall Survival|Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.|2 years post-transplant|intention to treat||participants|||Number
79079|NCT01009619|Primary|Prevalence of Bronchiolitis Obliterans Syndrome (BOS)|BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.|2 years post-transplant|intention to treat analysis||participants|||Number
79080|NCT01009580|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
79081|NCT01009580|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
79082|NCT01009580|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS. For 24 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
79083|NCT01009580|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
79084|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79085|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79086|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79257|NCT01008449|Secondary|Post Operative Pain - 4 - 6 Weeks Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|at end of follow-up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
79087|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79088|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79089|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79090|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79091|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79092|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79121|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79093|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79094|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79095|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79096|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79097|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79098|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79099|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79258|NCT01008449|Secondary|Operative Procedure Time.|time for procedure as measured in minutes|Intraoperative, at time of intervention.|||minutes||Inter-Quartile Range|Median
79100|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79101|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79102|NCT01009554|Secondary|Mean Stain Area for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79103|NCT01009554|Secondary|Mean Stain Area for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79104|NCT01009554|Secondary|Mean Stain Area for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79105|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79106|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79259|NCT01008449|Secondary|Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))|The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).|at the end of follow up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
79107|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79108|NCT01009554|Secondary|Mean Stain Score for Body Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79109|NCT01009554|Secondary|Mean Stain Score for Body Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79110|NCT01009554|Secondary|Mean Stain Score for Body Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79111|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79112|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79113|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79122|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79114|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79115|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79116|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79117|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79118|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79119|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79120|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79123|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79124|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79125|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79126|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79127|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79128|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79129|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
86867|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|||L||Standard Deviation|Mean
79130|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79131|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79132|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79133|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79134|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79135|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79143|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
80518|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
79136|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79137|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79138|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79139|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79140|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79141|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79142|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79165|NCT01009203|Secondary|Toxicity Profile|Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.|3 years|Participants who received t least one dose of on-study treatment||participants|||Number
79144|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79145|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79146|NCT01009554|Primary|Oral Tissue Tolerance|Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.|through 8 weeks|Analysis was based on the Safety Analysis Set, defined as all participants who used at least one dose of investigational product.||percentage of participants|||Number
79147|NCT01009554|Primary|Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
79148|NCT01009515|Secondary|Time to Progression|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|The 16 patients who completed treatment were evaluable for progression-free survival.||weeks||95% Confidence Interval|Median
79149|NCT01009515|Secondary|Safety Profile|All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.|Up to 30 days after last on-study treatment, for up to 2 years|All patients who had received at least one dose of on-study treatment were evaluable for toxicity.||participants|||Number
79150|NCT01009515|Secondary|Overall Survival|The time from treatment initiation to death by any cause.|2 years|The 16 patients who completed treatment were evaluable for survival analysis.||weeks||95% Confidence Interval|Median
79151|NCT01009515|Primary|Objective Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.|6 months|The 16 patients who completed treatment were evaluable for the endpoint of overall response rate.||participants|||Number
79152|NCT01009463|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
79153|NCT01009463|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
79154|NCT01009463|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population||Participants|||Number
79155|NCT01009463|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
79156|NCT01009346|Secondary|Clinical Activity of This Regimen Correlates With Markers of the EGF-R/mTOR Pathway in Tumor Tissue & the Role of FDG PET in Early Imaging.|Early termination due to toxicity|1 year||||||
79157|NCT01009346|Secondary|Response Rate of RAD001 at MTD in Combination With Weekly Cetuximab & Cisplatin.|Early termination due to toxicity|1 year||||||
79158|NCT01009346|Primary|Progression Free Survival (PFS) of RAD001 at MTD in Combination With Weekly Cetuximab and Cisplatin.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|1 year|||months||95% Confidence Interval|Median
79159|NCT01009346|Primary|Maximum Tolerated Dose (MTD) of RAD001 in Combination With Cetuximab and Cisplatin.|Early termination due to toxicity|Phase 1 will enroll over 6 months||||||
79160|NCT01009333|Secondary|Number of Pads Per Day|In a diary, subjects are asked to provide number of pads they used per day.|three weeks|||Pads Per Day||Standard Deviation|Mean
79161|NCT01009333|Secondary|Number of Voids Per Day|In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.||Voids Per Day||Standard Deviation|Mean
79162|NCT01009333|Primary|Number of Urinary Incontinent Episodes Per Day|In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.||Episodes Per Day||Standard Deviation|Mean
79163|NCT01009203|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|3 years|||months||Full Range|Median
79164|NCT01009203|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses|3 years|Participants evaluable for response||percentage of evaluable participants|||Number
79166|NCT01009203|Primary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.|3 years|||Months||Full Range|Median
79167|NCT01009138|Secondary|Health-care Costs: Medication Intake|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU|||number of daily medications/half year||Standard Deviation|Mean
79168|NCT01009138|Secondary|Health-care Costs: Non-productive Time|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU|||number of days on sick leave/half year||Standard Deviation|Mean
79169|NCT01009138|Secondary|Health-care Costs: Health-care Utilisation|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU|||number of medical appointment/half year||Standard Deviation|Mean
79170|NCT01009138|Secondary|Inflammatory Marker Hs-CRP|The inflammatory marker high sensitivity C-reactive protein (hs-CRP) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU|||mg/dl||95% Confidence Interval|Mean
79171|NCT01009138|Secondary|Inflammatory Marker IL-1Ra|The inflammatory marker Interleukin 1 receptor antagonist (IL-1Ra) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU|||pg/ml||95% Confidence Interval|Mean
79172|NCT01009138|Secondary|Inflammatory Marker IL-6|The inflammatory marker Interleukin 6 (IL-6) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU|||pg/ml||95% Confidence Interval|Mean
79173|NCT01009138|Secondary|Glycemic Control (HbA1c)|The HbA1c was used as measure of glycemic control. All blood samples were analysed in a central laboratory using the Bio-Rad II Turbo analyser; the measurement units were %-points. Based on the measurement at baseline and 12-month follow up, the difference of the HbA1c values between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||%-points||Standard Deviation|Mean
79174|NCT01009138|Secondary|Diabetes Acceptance (AADQ Score)|The Acceptance and Action Diabetes Questionnaire (AADQ) was used to assessment of diabetes acceptance. Using 11 items on diabetes-related experiential avoidance behaviours and a 5-point Likert response scale (1 - 5), the AADQ estimates the overall level of diabetes acceptance. Item scores are summed to a total score between 11 and 55 with higehr scores indicating better acceptance. Based on the measurement of diabetes acceptance at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
79175|NCT01009138|Secondary|Diabetes Self-Care (SDSCA Score)|The Summary of Diabetes Self-Care Activities Measure (SDSCA) was used to assess diabetes self-care. The SDSCA assesses the number of days of the previous week (0 - 7) on which several specific self-care activities (appropriate diet, physical activity, self-monitoring of blood glucose, foot care) were performed. The item scores are summed and averaged to a total score from 0 to 7 with higher scores indicating better overall self-care. Based on the measurement of diabetes self-care at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
79176|NCT01009138|Secondary|Diabetes-specific Distress (PAID Score)|The Problem areas in Diabetes Scale (PAID) was used to assess diabetes-specific distress. The PAID assesses diabetes-specific distress using 20 items and a five-point Likert scale (0 - 4). Item scores are summed and transformed to a range from 0 - 100 with higher scores indicating higher distress. Based on the measurement of diabetes-specific distress at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
79177|NCT01009138|Secondary|Quality of Life (EQ-5D TTO Score)|The EuroQol Five Dimension Questionnaire (EQ-5D) was used to assess health-related quality of life (HRQOL). The EQ-5D assesses five dimensions of HRQOL using a 3-point scale. The item scores are weighted based on population data and used to calculate a standardised total score from 0 to 1 with higher scores indicating better HRQOL. Based on the measurement of HRQOL at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline,12 month FU|||Scores on a scale||Standard Deviation|Mean
79178|NCT01009138|Primary|Depressive Symptoms (CES-D Score)|The Center for Epidemiologic Studies Depression Scale (CES-D) was used to assess depressive symptoms. The CES-D assesses the frequency of 20 typical symptoms of depression during the previous week on a 4-point Likert scale. Summing of the item scores estimates the total score with a range between 0 and 60 and higher scores indicating more severe depressive mood. Based on the measurement of depressive symptoms at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU|||Scores on a scale||Standard Deviation|Mean
79179|NCT01009099|Primary|Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)|The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.|baseline and 12 weeks|Patients who completed 12 weeks of exercise training were analyzed. There was one patient in each group that did not complete the treadmill test at 12 weeks although they completed other secondary outcome measures. Although they did not complete this measure, they remained in the study and were not counted as a drop.||minutes||Standard Deviation|Mean
79180|NCT01009086|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.||Score on a scale||Standard Deviation|Mean
79181|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
79182|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
79183|NCT01009086|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.||Percentage of participants|||Number
79184|NCT01009086|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Score on a scale||Standard Deviation|Mean
79194|NCT01009047|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 56|The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
79195|NCT01009034|Secondary|Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.||6 months|||h*mg/L||Inter-Quartile Range|Median
79185|NCT01009086|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters [cm]) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.||Percentage of participants|||Number
79186|NCT01009047|Secondary|Number of Participants With PANSS Response|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Participants|||Number
79187|NCT01009047|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182|The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a Scale||Standard Deviation|Mean
79188|NCT01009047|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182|"The CGI-S rating scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Full Range|Median
79189|NCT01009047|Secondary|Number of Participants With Clinical Stability|Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Participants|||Number
79190|NCT01009047|Secondary|Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
79191|NCT01009047|Secondary|Change From Baseline in Other Marder Factors Scores at Day 56 and 182|The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
79192|NCT01009047|Secondary|Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182|The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
79193|NCT01009047|Secondary|Change From Baseline in PANSS Total Score at Day 182|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.||Units on a scale||Standard Deviation|Mean
79196|NCT01009034|Secondary|Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval|For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample|||ratio||Inter-Quartile Range|Mean
79197|NCT01009034|Primary|Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Speciﬁ- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2–6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals.||Inhibitory concentration ratio||Inter-Quartile Range|Median
79198|NCT01008995|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline (Week 0) to Week 12|Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group.||Score||Standard Deviation|Mean
79199|NCT01008995|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|All participants were included and analyzed according to their randomized treatment group.||Participants|||Number
79200|NCT01008995|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.|Scores could range from 0 (mild) to 72 (severe).|Baseline (Week 0) to Week 12|All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received.||Participants|||Number
79201|NCT01008969|Secondary|Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection. The imaging studies qualitatively detected radiotracer distribution within the prostate and local lymphatic system. The detection of the radiotracer distribution was performed by experienced attending nuclear medicine physicians at UCSF. The qualitative detection includes visual lymph node uptake seen by SPECT scans overlaid on coregistered CT scans.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. We calculated the percentage of images with detectable lymph nodes from SPECT/CT images in these participants.||percentage of images identifying LNs|||Number
79202|NCT01008969|Primary|Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection|Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. Percentage of participants who received SPECT/CT scans of 99mTc-sulfur nanocolloid was analyzed.||Percentage of Participants|||Number
79203|NCT01008943|Primary|Number of Participants That Experienced AMDC Product-related Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.~No adverse events reported during the study were adjudicated as AMDC product-related."|12 months|||participants|||Number
79204|NCT01008943|Primary|Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days|||events|||Number
79205|NCT01008943|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days|||participants|||Number
79206|NCT01008943|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.|at biopsy or between biopsy and treatment, approximately 6 weeks|One patient experienced procedural dizziness.||participants|Participants||Number
79207|NCT01008904|Secondary|Difference in Quality of Life|Mayo Clinic Uniscale instrument (6 questions with each question rating 0=as bad as it can be and 10=as good as it can be). A lower score is considered to be a better outcome.|from baseline to week 5|Participants who completed treatment||units on a scale||Standard Error|Mean
79208|NCT01008904|Primary|Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)|Hot flash score (frequency x severity) at baseline was compared to the end of treatment. The number of flashes in a 24 hour day and a score combining the number and severity of hot flashes (ie, 1 point for mild, 2 points for moderate, 3 points for severe and 4 points for very severe.|from baseline to week 5|25 patients completed the complete study and were analyzed||percentage of difference||Standard Error|Mean
79211|NCT01008696|Secondary|Overall Assessment of Study Medication by Investigator|Investigator’s overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad.|Day 57|The FAS included participants who received the study medication at least once and had follow-up data that could be used after the Baseline among the participants meeting the eligibility criteria of this study. LOCF was used. Here, 'N'=participants evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
79212|NCT01008696|Secondary|Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire|Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping.|Baseline and Day 57|The FAS included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure||Units on a scale||Standard Deviation|Mean
79213|NCT01008696|Primary|Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19|Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers.|Day 57|The Full analysis set (FAS) included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure.||Percentage of participants|||Number
79214|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
79215|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Participants|||Number
79216|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79217|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79218|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79260|NCT01008449|Primary|Percent of Subjects With Composite Wound Morbidity.|this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed|4-6 weeks post partum|||percentage of subjects|||Number
79219|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79220|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
79221|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
79222|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
79223|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
79224|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
79225|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
79261|NCT01008280|Primary|Number of Heavy Drinking Days Per Two Week Segment|A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male|12 weeks|||Number of heavy drinking days/2 weeks||Standard Error|Mean
79262|NCT01008280|Primary|Number of Drinks Consumed Per Two Week Segments||12 weeks|||Number of Drinks/2 Weeks||Standard Error|Mean
79226|NCT01008618|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Days||95% Confidence Interval|Median
79227|NCT01008605|Secondary|Number of Participants Providing Comments to Any Question on the Participant Assessment Tool|Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
79228|NCT01008605|Secondary|Time Required to Perform Each Step While Using the Caverject Impulse Delivery System|Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.|Day 1|FAS. Each participant tested one device/dose combination. n = number of participants with available data.||seconds||Standard Deviation|Mean
79229|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4|Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
79230|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3|Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
79231|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2|Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
79232|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1|Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|FAS. Each participant tested one device/dose combination.||participants|||Number
79233|NCT01008605|Primary|Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System|Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (>) 80% overall.|Day 1|Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination.||percentage of participants|||Number
79234|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
79235|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Participants|||Number
79236|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79237|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79263|NCT01008280|Primary|Number of Drinking Days in the Past Two Weeks||12 Weeks|||Number of Drinking Days/2 weeks||Standard Error|Mean
79266|NCT01007838|Primary|Muscle Cross Sectional Area|Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.|Change from baseline in cross sectional area at 12 weeks|Per protocol. All participants completing the study were analyzed.||cm2||Standard Deviation|Mean
79238|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79239|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
79240|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
79241|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Treatments per day||Standard Deviation|Mean
79242|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
79243|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||Participants|||Number
79244|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
79264|NCT01007916|Primary|Comfort Upon Insertion|Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review.||Units on a Scale||Standard Deviation|Mean
79245|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.||mm||Standard Deviation|Mean
79246|NCT01008553|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.||Days||95% Confidence Interval|Median
79247|NCT01008475|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.|Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||months||95% Confidence Interval|Median
79248|NCT01008475|Secondary|Number of Subjects With Tumor Response|Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.|Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||Subjects|||Number
79249|NCT01008475|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.|Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||months||95% Confidence Interval|Median
79250|NCT01008475|Secondary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.|Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.||months||95% Confidence Interval|Median
79251|NCT01008475|Primary|Randomized Part: Progression Free Survival (PFS)|PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.|Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|Intention-to-treat (ITT) analysis set included all the subjects who were randomized into the treatment groups.||months||95% Confidence Interval|Median
79252|NCT01008475|Primary|Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)|DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.|Time from the first dose of study drug up to 2 weeks|Dose-escalation analysis set included subjects who received atleast 1 dose of EMD 525797 and who met atleast 1 of the following: Did not withdraw before the end of DLT evaluation period (2 weeks from 1st drug intake) for reasons other than DLT;those who experienced a DLT during this period and received 1 dose of EMD 525797 as per cohort allocation.||subjects|||Number
79253|NCT01008449|Secondary|Subject Satisfaction With Location of Scar|Satisfaction with location of scar was reported by subject using a scale of 1 - 5. A score of 1 would be the worst location of a scar and a score of 5 would be the best location of a scar|at end of follow-up, 4 - 6 weeks post partum|||units on a scale||Inter-Quartile Range|Median
79265|NCT01007838|Secondary|Muscle Strength|Bilateral knee extensor isometric strength.|Change from baseline in muscle strength at 12 weeks||||||
79267|NCT01007812|Primary|Overall Vision|Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week’s wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per Protocol||Units on a Scale||Standard Deviation|Mean
79268|NCT01007656|Primary|R-glutamyl Transpeptidase (r-GT)||90 days|||U/L||Standard Deviation|Mean
79269|NCT01007656|Primary|Glucose||90 days|||mg/dL||Standard Deviation|Mean
79270|NCT01007656|Primary|Globulin||90 days|||g/dL||Standard Deviation|Mean
79271|NCT01007656|Primary|Creatinine||90 days|||mg/dL||Standard Deviation|Mean
79272|NCT01007656|Primary|Cholesterol||90 days|||mg/dL||Standard Deviation|Mean
79273|NCT01007656|Primary|BUN||90 days|||mg/dL||Standard Deviation|Mean
79274|NCT01007656|Primary|Total Bilirubin|Bilirubin is released into the blood when red blood cells break down. The liver uses bilirubin to make bile. Normally there is only a small amount of bilirubin in the blood. High levels may be caused by liver or blood problems.|90 days|||mg/dL||Standard Deviation|Mean
79275|NCT01007656|Primary|Direct Bilirubin|Direct bilirubin is referred to as conjugated bilirubin, which is water-soluble. It's taken up by the liver cells and conjugated to form the water-soluble bilirubin diglucuronide. It's used to diagnose and/or monitor liver diseases, such as cirrhosis, hepatitis or gallstones. If direct bilirubin is elevated more than unconjugated bilirubin, there's typically a problem associated with decreased elimination of bilirubin by the liver cells.|90 days|||mg/dL||Standard Deviation|Mean
79276|NCT01007656|Primary|Alkaline Phosphatase||90 days|||U/L||Standard Deviation|Mean
79277|NCT01007656|Primary|Albumin||90 days|||g/dL||Standard Deviation|Mean
79278|NCT01007656|Primary|Uric Acid||90 days|||mg/dL||Standard Deviation|Mean
79279|NCT01007656|Primary|Total Protein|The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.|90 days|||g/dL||Standard Deviation|Mean
79280|NCT01007656|Primary|Triglycerides (TG)||90 days|||mg/dL||Standard Deviation|Mean
79281|NCT01007656|Primary|Serum Glutamic Pyruvate Transaminase (ALT/SGPT)||90 days|||U/L||Standard Deviation|Mean
79282|NCT01007656|Primary|Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)||90 days|||U/L||Standard Deviation|Mean
79283|NCT01007643|Secondary|Change in Vastus Medialis Oblique Muscle Strength||3 months||||||
79284|NCT01007643|Secondary|Change in Quadriceps Flexibility||3 months||||||
79285|NCT01007643|Secondary|Change in Hamstring Flexibility||3 months||||||
79286|NCT01007643|Secondary|Changes in Patellofemoral Symptoms||3 months||||||
79287|NCT01007643|Primary|Percentage of Exercise Days Completed.|Calculated for the 12 week period as daily exercise completion rate as percentage|3 months|Per Protocol||percentage of days completed||Full Range|Mean
79288|NCT01007435|Secondary|Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52|The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
79289|NCT01007435|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52|The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
79290|NCT01007435|Secondary|Percentage of Participants With a Major Clinical Response at Week 52|A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
79291|NCT01007435|Secondary|Change From Baseline in Sharp Joint Space Narrowing Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
79292|NCT01007435|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
79293|NCT01007435|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Units on a scale||Standard Deviation|Mean
79302|NCT01007253|Secondary|Total Number of Sneezes||50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||sneezes||Full Range|Median
79294|NCT01007435|Secondary|Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52|Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
79295|NCT01007435|Secondary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52||Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
79296|NCT01007435|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24|A participant has a DAS28 remission response if their DAS28 < 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Week 24|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.||Percentage of participants|||Number
79297|NCT01007396|Secondary|Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)|"The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation~Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution.~The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml."|3 months after LTBI treatment|Thirteen participants agreed to undergo treatment for latent tuberculosis infection and completed 3 months therapy.||Percentage of participants|||Number
79298|NCT01007396|Primary|Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea|The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).|QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.|Of the 322 healthcare workers (HCWs), 275 (85%) underwent repeat QuantiFERON-TB Gold In-Tube test (QFT-IT test) after 1 year of employment; the 47 participants who had resigned were excluded. Two participants with indeterminate results on the baseline QFT-IT test were excluded from the analysis.||number of new cases per 1000 person/year|||Number
79299|NCT01007253|Secondary|Total Number of Eosinophils|The percentage of eosinophils among white blood cells was determined under light microscopy at 1000x magnification, and the total number of eosinophils in each lavage was then calculated. The specimens that had no eosinophils identified on differential counting despite adequate cells on the smear were assigned a number that corresponded to the lowest number of eosinophils on a slide where the number could be counted. That number was 33 total eosinophils.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||eosinophils||Full Range|Median
79300|NCT01007253|Secondary|Change in Tryptase Level (Across Nasal Challenges)|"Tryptase is an enzyme that is released, along with histamine and other chemicals, from mast cells when they are activated, often as part of an allergic immune response. Tryptase in nasal lavages was measured using the ImmunoCap tryptase assay, by Phadia (Uppsala, Sweden). The limit of detection of the assay is 1.0 ng/mL, and levels below this value were arbitrarily assigned a value of 0.5 ng/mL.~For each patient, tryptase levels recorded after the diluent challenge were subtracted from tryptase levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in tryptase level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||ng/mL||Full Range|Median
79301|NCT01007253|Secondary|Change in Histamine Level (Across Nasal Challenges)|"Histamines are simple chemical substances produced by immune system cells when reacting to an antigen in response to foreign invaders like germs and bacteria.~Histamine in nasal lavages was measured using a histamine enzyme immunoassay kit market by SPI-BIo, Bertin Pharma (Montigny le Bretonneux, France). The limit of detection of the assay is 0.4 nM, and levels below the detection limit were arbitrarily assigned a value of 0.2 nM. Samples that yielded values above the upper detection limit of the assay were diluted and reassayed.~For each patient, histamine levels recorded after the diluent challenge were subtracted from histamine levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in histamine level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||nM||Full Range|Median
79303|NCT01007253|Secondary|Total Nasal Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one nostril and was asked to rate nasal symptoms (congestion, rhinorrhea, and itchy nose/throat) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of nasal symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other nostril. The outcome is the total number of score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (congestion, rhinorrhea, and itchy nose/throat), and nostrils (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||units on a scale||Full Range|Median
79304|NCT01007253|Primary|Total Eye Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.||units on a scale||Full Range|Median
79305|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI||Percent change in MFI||Standard Deviation|Mean
79306|NCT01007149|Secondary|Number of Patients With at Least One Asthma-related Event Over 16 Weeks|Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Participants|||Number
79307|NCT01007149|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks|Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Liters||Standard Deviation|Mean
79308|NCT01007149|Secondary|Physician and Patient Global Evaluation of Treatment Effectiveness|The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Participants|||Number
79309|NCT01007149|Secondary|Change From Baseline in Nasal Symptom Global Score and Individual Components|Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Score units||Standard Deviation|Mean
79310|NCT01007149|Secondary|Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)|The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment||Score units||Standard Deviation|Mean
79311|NCT01007149|Secondary|Change From Baseline in Induced Sputum Eosinophil Count|The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.|Baseline and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. Only patients with measurements at both baseline and week 16 were included in this analysis.||Percentage of total nonsquamous cells||Standard Deviation|Mean
79312|NCT01007149|Secondary|Change in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.|Baseline and 4, 8, 12 and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. During different time points, participants with observations at that time point were included in the analysis.||parts per billion (ppb)||Standard Deviation|Mean
79313|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI||Percent change in MFI||Standard Deviation|Mean
79314|NCT01007110|Secondary|Cardiac Conduction Time||Change from Baseline to 2 Months Post-natal|||milliseconds||Standard Deviation|Mean
79315|NCT01007110|Secondary|Cord Blood Phospholipids DHA|Newborn red blood cell phospholipids collected at birth.|Birth|||weight percent total fatty acids||Inter-Quartile Range|Median
79316|NCT01007110|Secondary|Maternal Red Blood Cell (RBC) Phospholipids at Delivery|Maternal red blood cell phospholipid collected at delivery. These results were compared to baseline red blood cell phospholipid that was collected at study enrollment. A weighed standard fatty acid mixture (Supelco 37 component fatty acid methyl ester mix,Sigma Aldrich) was employed to correct final DHA weight percent of total fatty acids (wt%TFA).|Time of delivery, 36 weeks to term|||weight percent Total Fatty Acids||Inter-Quartile Range|Median
79317|NCT01007110|Secondary|Neonatal Behavioral Assessment Scale (NBAS) Scores|"The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas.~For behavioral items a higher score corresponds to more desirable outcomes:~Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27.~Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 – 63.~Motor: Sum of scores across 5 items; 3 scored on a scale of 1-9, 1 scored on a scale of 1-6, and 1 scored on a scale of 1-5. Range: 5-38.~Range of State: Sum of scores across 4 items; 2 scored on a scale of 1-6 and 2 scored on a scale of 1-5. Range: 4-22.~Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36.~Autonomic Stability: Sum of scores across 3 items; 1 scored on a scale of 1-9, 1 on a scale of 1-8, and 1 on a scale of 1-6. Range: 3-23.~Reflexes: Sum across the 18 items, scored on a scale of 0-3. Range: 0 to 54. The supplementary items are each scored on a scale of 1-9 and do not combine to form a composite."|within 2 weeks of delivery|||units on a scale||Standard Deviation|Mean
79318|NCT01007110|Primary|Heart Rate|Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.|24, 32 and 36 weeks gestational age|"Placebo: 19 subjects @ 24 wks GA, 25 subjects @ 32 wks GA, 24 subjects @ 36 wks GA~DHA: 21 subjects @ 24 wks GA, 23 subjects @ 32 wks GA, 22 subjects @ 36 wks GA"||Beats per minute||Standard Deviation|Mean
79319|NCT01006980|Secondary|Pre and Post-dose Plasma Vemurafenib Concentration by Study Day|The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.|Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).|"The pharmacokinetic (PK) analysis population included all participants who received vemurafenib and provided valid PK assessments. The PK population at specific time points varied depending on the availability of confirmed dosing and PK assessment times. n indicates the number of participants with available PK data at each time point."||μg/mL||Standard Deviation|Mean
79320|NCT01006980|Secondary|Number of Participants With Adverse Events (AEs)|The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.|From randomization (initiated January 2010) until December 30, 2010.|The safety population was defined as all treated participants who had at least one on-study assessment. The safety population was analyzed according to the treatment received.||participants|||Number
79321|NCT01006980|Secondary|Time to Treatment Failure|Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.|approximately 3 years||||||
79322|NCT01006980|Secondary|Time to Confirmed Response|Time to response was defined as the time from randomization to confirmed response (complete response or partial response).|From randomization (initiated January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.||months||Full Range|Median
79323|NCT01006980|Secondary|Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan–Meier method.|From randomization (initiated in January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.||months||95% Confidence Interval|Median
79324|NCT01006980|Secondary|Participants With a Best Overall Response (BOR) of Complete Response or Partial Response|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.|From randomization (initiated January 2010) until December 30, 2010|The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments.||participants|||Number
79387|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent|24 Weeks|||Percentage of patients|||Number
79325|NCT01006980|Primary|Progression-free Survival|A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).|From randomization (initiated January 2010) to December 30 2010.|The analysis population for PFS consisted of all ITT participants randomized by October 27, 2010 (at least 9 weeks prior to the clinical cutoff date of December 30, 2010). The 9-week interval was chosen to allow time for participants to have had their first scheduled post baseline tumor assessment CT scan.||participants|||Number
79326|NCT01006980|Primary|Overall Survival|An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.|From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).|The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.||participants|||Number
79327|NCT01006889|Secondary|Change in Anthropometric Variables (BMI).||6 months|The number of participants included were the ones that completed the study.||Kg/m2||Standard Deviation|Mean
79328|NCT01006889|Secondary|Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience).|Change in lipid levels vs. pretreatment.|6 months|Number of patients completing.||mg/dl||Standard Deviation|Mean
79329|NCT01006889|Secondary|Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp|M value represents glucose infusion change|6 months|The number of participants included were the ones that completed the study.||percentage change vs pretreatment||Standard Deviation|Mean
79330|NCT01006889|Secondary|Insulin Secretion (Hyperglycemic Clamp)|Change in C-peptide levels vs. pretreatment in the first and second phase.|6 months|The number of participants included were the ones that completed the study.||ng/ml||Standard Deviation|Mean
79331|NCT01006889|Secondary|Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events.||6 months|The number of participants included were the ones that completed the study.||number of events|||Number
79332|NCT01006889|Secondary|Change in Anthropometric Variables (Weight).||6 months|The number of participants included were the ones that completed the study.||Kg||Standard Deviation|Mean
79333|NCT01006889|Secondary|A1c|Patients with controlled T2DM with bedtime insulin alone (n=5) or bedtime insulin and premeal rapid-acting insulin novolog (n=15) had eventide given twice daily for 6 months (if on premeal insulin it was stopped). The goal is to assess if adding SQ exenatide is effective to maintain optimal glycemic control in this population.|6 months|The number of participants included were the ones that completed the study.||percentage of A1c||Standard Deviation|Mean
79334|NCT01006889|Primary|Hepatic Steatosis|Hepatic steatosis was assessed non-invasively by MRS.|6 months|The number of participants included were the ones that completed the study.||Percentage of liver fat||Standard Deviation|Mean
79335|NCT01006655|Primary|Adenosine Challenge Test|Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded|ten weeks|||mg/ml||Standard Deviation|Mean
79336|NCT01006629|Secondary|Total Days of Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
79337|NCT01006629|Secondary|Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||participants|||Number
79338|NCT01006629|Secondary|Total Days of RSV ICU Stay|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
79339|NCT01006629|Secondary|Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization|Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||participants|||Number
79340|NCT01006629|Secondary|Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
79341|NCT01006629|Secondary|Total Number of RSV Hospitalization Days|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab|||days||Standard Deviation|Mean
79342|NCT01006629|Primary|Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)|Number of subjects experiencing an RSV hospitalization|Through 30 days following the last injection of palivizumab|||participants||95% Confidence Interval|Number
79343|NCT01006629|Primary|Frequency of Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.|Through 30 days following the last injection of palivizumab|||participants|||Number
79388|NCT01006590|Primary|Absolute Change From Baseline in HbA1c at Week 24||Baseline and 24 weeks|||Percent (%)||Standard Error|Mean
79575|NCT01004874|Secondary|Median Overall Survival|OS was defined as time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat||months||95% Confidence Interval|Median
79344|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Any Type of Infection|The percentage of participants who experienced an AE related to any type of infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.||Percentage of Participants|||Number
79345|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Respiratory Infection|The percentage of participants who experienced an AE related to a respiratory infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.||Percentage of Participants|||Number
79346|NCT01006616|Secondary|Change From Baseline in Percent of Arterial Oxygen Saturation Measured by Pulse Oximetry Before and After the 6-Minute Walk Test|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. Percent (%) of arterial oxygen saturation, as measured by pulse oximetry, was to be assessed before and after the 6-minute walk test at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test arterial oxygen saturation. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Percent Oxygen Saturation||Standard Error|Least Squares Mean
79347|NCT01006616|Secondary|Change From Baseline in Pre- and Post-6-Minute-Walk-Test Borg Scale Score|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. The Borg scale is a method use to rate perceived exertion (0=Nothing at all [no exertion] to 10=Maximal [exertion]). Borg scale scores were to be assessed pre- and post-walk-test at Baseline, Week 26, Week 52 and Week 104. A higher score indicates greater perceived exertion.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test Borg scale score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
79348|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Epithelial Cell-Derived Neutrophil Activating Peptide 78 (ENA-78)|Blood samples were to be collected prior to study drug administration to determine participant plasma ENA-78 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for ENA-78 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||pg/mL||Standard Deviation|Least Squares Mean
79349|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Plasma Neutrophil Elastase|Blood samples were to be collected prior to study drug administration to determine participant plasma neutrophil elastase levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma neutrophil elastase level. The study was terminated during Period 2; no data were collected for the endpoint at Week 104.||ng/mL||Standard Deviation|Least Squares Mean
79350|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Matrix Metallopeptidase-9 (MMP-9)|Blood samples were to be collected prior to study drug administration to determine participant plasma MMP-9 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||ng/mL||Standard Deviation|Least Squares Mean
79351|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Myeloperoxidase (MPO)|Blood samples were to be collected prior to study drug administration to determine participant plasma MPO levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||ng/mL||Standard Deviation|Least Squares Mean
79461|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).|The initial mean Ktrans at baseline, 4 weeks and 10 week. K trans is used to describe the uptake of gadolinium contrast in tissue.|baseline, 4 weeks and 10 weeks|||min^ -1||Standard Deviation|Mean
79352|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Fibrinogen|Blood samples were to be collected prior to study drug administration to determine participant plasma fibrinogen levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma fibrinogen level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||mg/dL||Standard Deviation|Least Squares Mean
79353|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: High-sensitivity C-reactive Protein (Hs-CRP)|Blood samples were to be collected prior to study drug administration to determine participant plasma hs-CRP levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma hs-CRP level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||mg/dL||Standard Deviation|Least Squares Mean
79354|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Matrix Metallopeptidase-9 (MMP-9)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MMP-9 levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for induced sputum MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||ng/mL||Standard Deviation|Least Squares Mean
79355|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Sputum Neutrophil Elastase|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. Neutrophil elastase levels were measured in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum neutrophil elastase level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||ng/mL||Standard Deviation|Least Squares Mean
79356|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Myeloperoxidase (MPO)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MPO levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||ng/mL||Standard Deviation|Least Squares Mean
79357|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Interleukin 8 (IL-8)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. IL-8 levels were measured by enzyme-linked immunosorbent assay (ELISA) in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum IL-8 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.||pg/mL||Standard Deviation|Least Squares Mean
79358|NCT01006616|Secondary|Change From Baseline in Modified Medical Research Council (MMRC) Dyspnea Score|The MMRC dyspnea scale is used to assess participant breathlessness. The MMRC dyspnea scale consists of five grades that describe almost the entire range of respiratory disability from none (Grade 0=Not troubled with breathlessness except with strenuous exercise) to almost complete incapacity (Grade 4=Too breathless to leave the house or breathless when dressing or undressing). MMRC dyspnea scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for MMRC dyspnea score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
86868|NCT00939185|Secondary|Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital|Time of exam completion minus the start time of the examination.|Day 1|Safety population||minutes||Full Range|Median
79359|NCT01006616|Secondary|Change From Baseline in Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Index Score|The BODE index is a composite score assessing COPD prognosis that consists of 4 variables that are individually scored: FEV1 percent predicted, 6-Minute Walk Test, Modified Medical Research Council (MMRC) dyspnea scale and body mass index (BMI). The FEV1 percent predicted was scored from ≥65% (0 points, less airway obstruction) to ≤35% (3 points, greater airway obstruction). The 6-Minute Walk Distance was scored from: ≥350 meters (0 points, good exercise capacity) to ≤149 meters (3 points, poor exercise capacity). The MMRC Dyspnea Scale was scored from: MMRC 0: Dyspneic on strenuous exercise (0 points) to MMRC 4: Cannot leave house; breathless on dressing/undressing (3 points). BMI was scored as: >21 (0 points) and ≤21 (1 point). Variable scores were summed to produce a BODE index score. BODE index scores could range from 0 to 10, with a higher score correlating with an increased risk of COPD mortality. BODE index scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for BODE index score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
79360|NCT01006616|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute with a peak flow meter, is the maximum speed of expiration. Participants were to perform at least 3 and up to 5 PEF measurements in the morning before taking study drug. PEF was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for PEF. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters/minute||Standard Error|Least Squares Mean
79361|NCT01006616|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC, as measured in liters by body plethysmography, is the maximum amount of air inspired when taking a slow, full inspiration with no hesitation from a position of passive end-tidal expiration (i.e. FRC) to a position of maximal inspiration. IC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for IC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
79362|NCT01006616|Secondary|Change From Baseline in Total Lung Capacity (TLC)|TLC, as measured in liters by body plethysmography, is the most amount of air lungs can hold at the top of breathing in. TLC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for TLC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
79363|NCT01006616|Secondary|Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters by body plethysmography, is the volume of air present in the lungs at the end of passive expiration. FRC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FRC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
79364|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|FVC, as measured in liters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for post-bronchodilator FVC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
79365|NCT01006616|Secondary|Change From Baseline in Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity (FEF25%–75%) Test|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute by spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. FEF25%-75% was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FEF25%-75%. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters/minute||Standard Error|Least Squares Mean
79366|NCT01006616|Secondary|Change From Baseline in Pre-bronchodilator FEV1|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Pre-bronchodilator FEV1 was to be assessed immediately before bronchodilator administration at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre-bronchodilator FEV1. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
79367|NCT01006616|Secondary|Change From Baseline in Distance Walked in 6 Minutes (6-Minute Walk Test)|The 6-minute walk test measures the distance participants can walk quickly on a flat, hard surface in 6 minutes. The 6-minute walk test was to be conducted at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for 6-minute walk test. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Meters||Standard Error|Least Squares Mean
79462|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume|mean tumor volume at baseline, 4 weeks and 10 weeks after start of treatment|baseline, 4 weeks and 10 weeks|||centimeters^3||Standard Deviation|Mean
79368|NCT01006616|Secondary|Change From Baseline in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score|The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms (frequency/severity), Activity (limited by breathlessness), Impacts (social functioning, psychological disturbances), and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. The Total score is calculated by summing the weights to all the positive responses in each component, dividing by the sum of weights for all items in the questionnaire, and multiplying this number by 100. SGRQ-C Total scores could range from 0-100, with a higher SGRQ-C Total score indicating greater disease burden. Participants were to assess their COPD symptoms, activity and impact at Baseline, Week 26, Week 52, and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for SGRQ-C score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Score on a Scale||Standard Error|Least Squares Mean
79369|NCT01006616|Secondary|Induced Sputum Absolute Neutrophil Counts|Induced sputum samples were to be obtained from participants via the nebulized method for analysis of absolute neutrophil counts at Week 26, Week 52 and Week 104. The reported Baseline least squares (LS) means and standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a baseline and Week 26, Week 52 or Week 104 assessment for sputum neutrophil count. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||10^9 cells/L||Standard Deviation|Least Squares Mean
79370|NCT01006616|Secondary|Total Exacerbations of Chronic Pulmonary Disease Tool-Patient-Recorded Outcome (EXACT-PRO) Questionnaire Score|The total score on the EXACT-PRO questionnaire is used to determine the frequency, severity, and duration of exacerbations of COPD. The 14-item EXACT-PRO questionnaire was to be completed by participants every evening to describe their experience of COPD during that day. Assessments were included for Breathlessness (5 items), Cough and Sputum (2 items), Chest Symptoms (3 items), and 4 additional items (Difficulty with Sputum, Tired or Weak, Sleep Disturbance, and Psychological State). Each item was measured on a 5- or 6-point scale. The total EXACT-PRO questionnaire score could range from 0 to 100, with a higher score indicating a more severe health state.|At 26, 52 and 104 weeks|The FAS population was to consist of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for total EXACT-PRO score. This analysis was not conducted if results for percentage of participants with moderate to severe COPD exacerbation suggested no need for further investigation.|||||
79371|NCT01006616|Secondary|Percentage of Participants With a Moderate to Severe COPD Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The percentages of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26, 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.||Percentage of Participants|||Number
79372|NCT01006616|Secondary|Number of Participants With a Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The numbers of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26 , 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.||Participants|||Number
79373|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator FEV1 (Period 2)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline, Week 52 and Week 104.|Baseline and Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 52 or Week 104 assessment for post-bronchodilator FEV1 in Period 2. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.||Liters||Standard Error|Least Squares Mean
79374|NCT01006616|Primary|Percentage of Participants With an Adverse Event (AE) Related to a Blood Absolute Neutrophil Count (ANC) of Less Than 1.5x10^9 Cells/L|The percentage of participants who experienced an AE related to an ANC of less than 1.5x10^9 cells/L at one or more visits during the first 26 weeks, the first 52 weeks and the first 104 weeks was to be calculated.|Up to 104 weeks|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 52 and up to 104 weeks.||Percentage of Participants|||Number
79463|NCT01005875|Primary|Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma|Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib|between baseline and 3 years|||participants|||Number
86884|NCT00939107|Secondary|Quality of Life|Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)|twelve months posttreatment||08/2010||||
79375|NCT01006616|Primary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Period 1)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline and Week 26.|Baseline and Week 26|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26 assessment for post-bronchodilator FEV1.||Liters||Standard Error|Least Squares Mean
79376|NCT01006603|Secondary|Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]|β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||percentage of change from baseline||95% Confidence Interval|Mean
79377|NCT01006603|Secondary|Change From Baseline to Week 52 in Insulin|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||µU/mL||95% Confidence Interval|Mean
79378|NCT01006603|Secondary|Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||mmol/L||95% Confidence Interval|Mean
79379|NCT01006603|Secondary|Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%|Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||percentage of responders|||Number
79380|NCT01006603|Secondary|Change From Baseline to Week 52 in HbA1c.|Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.|From week 0 to week 52.|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).||% of glycosylated hemoglobin||95% Confidence Interval|Mean
79381|NCT01006603|Secondary|Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.|"Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).||percentage of patients|||Number
79382|NCT01006603|Primary|Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.|"Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.~Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).||percentage of participants|||Number
79383|NCT01006590|Secondary|Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta||Baseline and 24 weeks|||Percent (%)||Standard Error|Mean
79384|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Insulin||Baseline and 24 weeks|||microUnit/milliLiter||Standard Error|Mean
79385|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose||Baseline and 24 weeks|||millimol/Liter||Standard Error|Mean
79386|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent|24 Weeks|||Percentage of patients|||Number
79389|NCT01006356|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.|Day 1 and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a Scale||Standard Deviation|Mean
79390|NCT01006356|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|Investigators evaluated the overall improvement of the participant’s condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s patient’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.|Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.||Participants|||Number
79391|NCT01006356|Secondary|Participant’s Preferences Along With Reasons|The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.|Day 15|The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.||Participants|||Number
79392|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Participant|Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', ‘effective response', ‘very effectiveresponse', and ‘highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."||Participants|||Number
79393|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Investigator|Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', ‘effective response', ‘very effectiveresponse', and ‘highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."||Participants|||Number
79394|NCT01006356|Secondary|Pain Intensity Score|Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.|Day 3 and Day 13|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
79395|NCT01006356|Secondary|Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15|K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.|Baseline and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.||Units on a scale||Standard Deviation|Mean
79396|NCT01006356|Secondary|Frequency of Experiencing Breakthrough Pain|Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.|Day 1 and Day 15|The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.||Pain episodes per day||Standard Deviation|Mean
79397|NCT01006356|Primary|Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain|Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).|Day 15|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.||Percentage of Participants|||Number
79477|NCT01005719|Secondary|Time to Onset of Inhibition of Acid Secretion on Day 1|The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed.|Treatment dose to onset of event on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Minutes||Full Range|Median
79398|NCT01006291|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group||Episodes/100 years of patient exposure|||Number
79399|NCT01006291|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group||Episodes/100 years of patient exposure|||Number
79400|NCT01006291|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'. For 28 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
79401|NCT01006291|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
79402|NCT01006135|Secondary|Patients With Any Adverse Events||6 months|TS||Number of participants|||Number
79403|NCT01006135|Secondary|Compliance of Patients|Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.|6 months|Patients from FAS||Number of participants|||Number
79404|NCT01006135|Secondary|Additional Bronchodilator or Inhaled Corticosteroids (ICS)|Pulmonary medication from baseline to visit 3 (6 months)|6 months|Patients from Full Analysis Set (FAS) which includes all patients from the TS who were assessed after administration of Spiriva, i.e. who have evaluable SGRQ measurements at visit 2 or visit 3.||Number of participants|||Number
79405|NCT01006135|Primary|Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline|The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline and 6 months|Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)||Units on a scale||Standard Deviation|Mean
79406|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState ) Composite Score|CogState had 5 outcome measures that measured the cognitive constructs. GMLT, detection, identification, one card learning and CPAL. GMLT score range: 0 (best) to infinity (worst), detection and identification score range: 2 (best) to 3.3 (worst); One card learning score range: 0 (worse) to 1.57 (best) and CPAL score range: 0 (best) to infinity (worst). The individual score was standardized at each assessment and was then averaged to yield a composite score; total possible score: minus infinity to plus infinity. Positive composite score=improved performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||Units on a scale||Standard Deviation|Mean
79407|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||errors||Standard Deviation|Mean
79408|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root of the proportion of correct responses. Score ranges from 0 (worse) to 1.57 (best). Higher scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||arcsine (square root proportion correct)||Standard Deviation|Mean
79500|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP G2677T/A|Serum digoxin concentration by ABCB1 SNP genotypes|Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
79501|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP C3435T|Serum digoxin concentration by genotypes for the ABCB1 SNP C3435T|Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
79409|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 msec). Score ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||log10 msec||Standard Deviation|Mean
79410|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (msec)]. Scores ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||log10 msec||Standard Deviation|Mean
79411|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 multiplied by 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||errors||Standard Deviation|Mean
79412|NCT01006122|Other Pre-specified|Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS)|Sheehan-STS is an 8-item clinician/participant administered prospective rating scale and an indicator of trigger assessment that tracks both treatment-emergent suicidal ideation and behaviors). Items 1a, 2-6, 8 scored on 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=very, and 4=extremely). Items 1, 1b, 7, an indicator of trigger assessment (TA) require yes/no response. Items included 1= Ever suffer any accident, 1a= Extent plan/intend to hurt yourself, 1b= Intend to die, 2= Wish dead, 3= Want to harm yourself, 4= Think about suicide, 5= Plan for a suicide, 6= Prepare for suicide (PS) with intent to die (ITD), 7= Injure yourself on purpose, 8= Attempt suicide. Result for item 1 indicates if any of the participant ever suffered any accident, 1b indicates if any of the participant intended to die, 7 indicates if any of the participant injured themselves purposely and trigger assessment indicates if any of the participant evoked trigger assessment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively. Results for a parameter are not reported at certain time points since none of the participants were evaluable for the parameter at those time points.||participants|||Number
79413|NCT01006122|Other Pre-specified|Medical Outcomes Study (MOS) Sleep Scale Score|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1(some questions are reversed so that high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range:0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create 7 scale scores and 2 sleep scale index. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), sleep quantity, snoring, awaken short of breath (ASoB), somnolence, sleep adequacy and optimal sleep; and a 9-item overall sleep problems index(SPI) I and II Subscales range from 0-100 except for sleep quantity (SQ) ranging from0 to 24. Except for sleep quantity, higher scores=greater impairment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
79414|NCT01006122|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum Fridericia’s correction of QT (QTcF) interval of 450 to <480 msec, 480 to <500 msec and >=500 msec. Number of participants who met the criteria for potential clinical concern in ECG findings were reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
79415|NCT01006122|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
79502|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T|55 patients in the Digoxin Dosing per Nomogram group consented to the Pharmacogenetic substudy and provided blood samples to perform pharmacogenetic analyses. We compared serum digoxin concentrations by ABCB1 genotype.|Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
79416|NCT01006122|Other Pre-specified|Number of Participants With Vital Signs Data|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (BP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP <50 mmHg, supine and standing heart rate <40 beats per minute (bpm) or >140 bpm. Number of participants who met the criteria for potential clinical concern was reported.|Baseline up to 7-10 days after Day 21 (stable dosing phase)|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||participants|||Number
79417|NCT01006122|Secondary|Clinical Global Impression of Improvement (CGI-I) Scale Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: “Compared to your subject’s condition at the beginning of treatment, how much has your subject changed?”. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
79418|NCT01006122|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality, social functioning (SF), role emotional (RE) and mental health (MH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
79419|NCT01006122|Secondary|Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase|Cataplexy is a medical condition in which a person suffers sudden physical collapse though remaining conscious. Cataplexy episodes is number of counts the participant had cataplexy.|Baseline, Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.||cataplexy episodes||Standard Deviation|Mean
79420|NCT01006122|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|BFI is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. There are 3 questions that pertain specifically to level of fatigue and 6 questions regarding general activity level, mood and quality of life, all are answered on an 11-point scale, with “0” being “No fatigue at all” to “10” being “As bad as you can imagine”. The global score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher global scores are associated with more severe fatigue.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
79421|NCT01006122|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|ESS is a simple, self-administered questionnaire which provides a measurement of the participant's general level of daytime sleepiness. The participant rates the chance that he/she would fall asleep when in 8 different situations (e.g. sitting and reading, talking to someone, etc.) commonly encountered in daily life on a scale of 0 (no daytime sleep) to 3 (maximum daytime sleep). Total score was the sum of 8 situations ranges from 0 to 24 with a higher score indicating greater daytime sleepiness.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
79422|NCT01006122|Primary|Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase|MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.|Baseline, Day 21 of stable dosing phase|"Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here N(number of participants analyzed) signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm."||minutes||Standard Deviation|Mean
79423|NCT01006018|Primary|Insulin Secretion|Not measured as study was prematurely terminated due to unanticipated delays.|baseline, 6 months, 9 months (after a 3 month washout)||||||
79424|NCT01005966|Secondary|Change From Baseline in Enamel Fluoride Uptake Potential|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population.||micrograms (μg)* F/centimeters(cm)^2||Standard Error|Mean
79503|NCT01005602|Secondary|Serum Digoxin Concentration < 1.0 ng/ml||Steady-state (2 - 4 weeks after initiation)|||percentage of participants|||Number
79504|NCT01005602|Secondary|Mean Serum Digoxin Concentration||Steady-state (2 - 4 weeks after initiation)|||ng/ml||Standard Deviation|Mean
79505|NCT01005602|Primary|Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml||Steady-state (2 - 4 weeks after initiation)|||percentage of participants|||Number
79425|NCT01005966|Secondary|Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)|SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.||Percentage SMHR||Standard Error|Mean
79426|NCT01005966|Primary|Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).|Baseline to 14 days|Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.||Percentage SMHR||Standard Error|Mean
79427|NCT01005914|Secondary|Half-life of Pegaspargase||The approximate t½ in adult patients is 5.73 days. The half-life is independent of the dose administered, disease status, renal or hepatic function, age, or gender.||||||
79428|NCT01005914|Secondary|Rate of Minimal Residual Disease|Cycle 1A: Days 1 through 14 Cycle 1B: Days 1 through 8, after the first 14 days of cycle 1A|End of cycles 1A and 1B||||||
79429|NCT01005914|Secondary|Overall Survival||At least every 6 months until death.||||||
79430|NCT01005914|Secondary|Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2||An interim analysis of safety is planned after the enrollment of 15 evaluable patients.||||||
79431|NCT01005914|Secondary|2-year Progression-free Survival||After completion of 8 cycles||||||
79432|NCT01005914|Primary|Grade 3 and 4 Toxicity Associated With the Combination of Peg-Asparaginase and Hyper-CVAD Which Include: Allergic Reactions, Elevated Liver Enzymes, Hyperbilirubinemia, Hyperglycemia, Central Nervous System (CNS) Thrombosis, and Pancreatitis.||The assessment of safety will be based mainly on the frequency of adverse events||||||
79433|NCT01005914|Primary|Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen|The complete response rate after 1A cycle of a PEG-Asparaginase and hyper-CVAD combination regimen will be estimated, and an exact 95% confidence interval will be computed using a binomial distribution.|After day 4 of treatment|Outcome Measure analysis was not performed due to early termination of the study due to safety concerns|||||
79434|NCT01005901|Secondary|Mean Daily Total Symptom Score Over the 26 Week Treatment Period|"The daily symptom score was calculated as the sum of the worst of the morning and evening assessments for each symptom (symptoms, cough, wheeze, sputum color/production, and breathlessness). The score can range from 0 to 18 with 0 indicating no symptoms. The higher the score, the worse the symptomatic status. A negative change (lower number) indicates improvement.~Mixed model used baseline symptom variables, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.||units on a scale||Standard Error|Least Squares Mean
79435|NCT01005901|Secondary|Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period|"The percentage of days able to perform usual daily activities is defined as the total number of days able to perform usual activities over the 26 week treatment period divided by the total number of days where diary recordings have been made.~Mixed model used baseline ability to perform usual daily activities, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.||percentage of days||Standard Error|Least Squares Mean
79436|NCT01005901|Secondary|Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period|"The percentage of days with no daytime symptoms is defined as the total number of days with no daytime symptoms over the 26 week treatment period divided by the total number of days where diary recordings have been made.~Mixed model used baseline daytime symptoms, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.||percentage of days with no symptoms||Standard Error|Least Squares Mean
79437|NCT01005901|Secondary|Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period|"The percentage of nights with no nighttime awakenings is defined as the total number of nights with no nighttime awakenings over the 26 week treatment period divided by the total number of night where diary recordings have been made.~Mixed model used baseline nighttime awakenings, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.||percentage of nights with no awakenings||Standard Error|Least Squares Mean
79438|NCT01005901|Secondary|Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period|One overall rate is calculated for the entire study population. Rate is the number of moderate or severe exacerbations per year = total number of moderate or severe exacerbations for all participants/total number of treatment years for all participants. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations were considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.||exacerbations per year|||Number
79439|NCT01005901|Secondary|Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|26 Weeks and 30 Day follow-up|The safety set included all patients who received at least one dose of study medication whether or not being randomized. Patients were randomized according to the treatment they received.||participants|||Number
79440|NCT01005901|Secondary|Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26|The mean heart rate was collected with a 24 hour Holter monitor in a sub-set of the safety population. The change between baseline and day 1, week 12 and week 26 was calculated. The analysis of the Holter recordings was performed by a central facility. Data on heart rate, heart rate variability, supraventricular and ventricular ectopy were collected and assessed.|Baseline, Day 1, Week 12 and Week 26|"The safety set included all patients who received at least one dose of study medication whether or not being randomized. A sub-set of the safety population had 24 hour Holter monitoring. n indicates patients with observations both at baseline and each endpoint."||beats per minute||Standard Deviation|Mean
79441|NCT01005901|Secondary|Trough FEV1 and FVC at Day 1 and Week 26|"Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.~Trough FVC was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FVC readings. Mixed model used baseline FVC, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. If one of the 23 h 15 min or 23 h 45 min values are missing then the remaining non-missing value is taken as trough FEV1 or trough FVC. If both values are missing, then their trough FEV1 or trough FVC is regarded as missing||Liters||Standard Error|Least Squares Mean
79442|NCT01005901|Secondary|FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 23 h 45 min post dose at week12/week 13and week 26/week 27 where available for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Week 12 and Week 26|Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed.||Liters||Standard Error|Least Squares Mean
79443|NCT01005901|Secondary|FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post dose at Week 1 Day 1, Week 12 and Week 26 for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1, Week 12 and Week 26|"Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed. n is the number of patients with non-missing observations at each time point."||Liters||Standard Error|Least Squares Mean
79444|NCT01005901|Secondary|Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FVC, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point.||Liters||Standard Error|Least Squares Mean
79445|NCT01005901|Secondary|FEV1 at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at all time points up to 4 hours post-dose, and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point||Liters||Standard Error|Least Squares Mean
79446|NCT01005901|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening. The total number of puffs of rescue medication per day over the full 26 weeks was calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients with observations both at baseline and week 26 were included in this analysis||Puffs per day||Standard Error|Least Squares Mean
79447|NCT01005901|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment|The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|"Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.~The median values were not estimable."||Days||95% Confidence Interval|Median
79448|NCT01005901|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Individual component score was imputed with LOCF (last observation carried forward).||Units on a scale||Standard Error|Least Squares Mean
79449|NCT01005901|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. Mixed model used baseline TDI, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients per treatment group with no missing data were included in this analysis.||Units on a scale||Standard Error|Least Squares Mean
79450|NCT01005901|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|12 weeks|Full Analysis Set (FAS) The FAS included all randomized patients who received at least one dose of study medication. Patients in this group were analyzed according to the treatment to which they were randomized. Missing trough FEV1 values at week 12 were imputed using LOCF with pre-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
79451|NCT01005888|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=20 C1INH-nf, N=22 placebo).||percent of functional C1INH||Standard Deviation|Mean
79452|NCT01005888|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=19 C1INH-nf, N=22 placebo).||mg/dL||Standard Deviation|Mean
79453|NCT01005888|Other Pre-specified|Total Number of Days of Swelling During Each Prophylactic Therapy Period|A day of swelling was defined as a day that a subject reported swelling at any of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity).|12 weeks|Efficacy Dataset.||days||Standard Deviation|Mean
79454|NCT01005888|Secondary|Number of Open-label C1INH-nf Infusions Required During Each Prophylactic Therapy Period|The study design allowed for subjects to be treated with open-label C1INH-nf for laryngeal angioedema, if deemed necessary by the investigator, or prior to emergency surgical procedures.|12 weeks|Efficacy Dataset.||infusions||Standard Deviation|Mean
79455|NCT01005888|Secondary|Average Duration of HAE Attacks During Each Prophylactic Therapy Period|"The duration of an attack was measured from the first report of swelling at any one of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity) until the first subsequent report of no swelling at all five locations."|12 weeks|Efficacy Dataset.||days||Standard Deviation|Mean
79456|NCT01005888|Secondary|Average Severity of HAE Attacks During Each Prophylactic Therapy Period|All attacks in each therapy period were assigned a value of 1 (mild), 2 (moderate), or 3 (severe). Attack severity was considered the highest value assigned by the subject to any swelling location during the attack. Average severity was set to 0 if there was no attack in a period.|12 weeks|Efficacy Dataset.||units on a scale||Standard Deviation|Mean
79457|NCT01005888|Secondary|Number of Subject Withdrawals During Each Prophylactic Therapy Period|At the end of each therapy period, each subject was assigned a yes/no drop-out status. A drop-out was defined as a subject who did not have a Week 12 visit record.|12 weeks|The Safety Dataset (N=24) consisted of all randomized subjects who received at least 1 complete or partial infusion of study drug. 24 subjects began Period 1 (12 C1INH-nf, 12 placebo) and received study drug. 22 subjects crossed over to Period 2 (11 placebo, 11 C1INH-nf) and received study drug. Thus, 23 randomized subjects received each therapy.||participants|||Number
79458|NCT01005888|Primary|Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period|An HAE attack was defined as the subject-reported indication of swelling at any location following a report of no swelling on the previous day. Analyses include observed attack counts and normalized attack counts (i.e., the number of attacks observed during each therapy period, normalized for the number of days the subject participated in that period).|12 weeks|The Efficacy Dataset (N=22) consisted of all randomized subjects who completed 12 weeks of therapy in Period 1 and received at least one infusion of study drug in Period 2.||attacks||Standard Deviation|Mean
79459|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).|the measured ADC at baseline, 4 weeks after baseline and then 10 weeks after baseline. ADC quantifies the motion of water protons from an MRI.|baseline, 4 weeks post baseline, 10 weeks post baseline|||1000 logs milimeters^2||Standard Deviation|Mean
79460|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.|The Kep as measures by MRI at baseline, 4 weeks after baseline, and 10 weeks after baseline.|baseline, 4 weeks after baseline and 10 weeks post baseline|||Min^ -1||Standard Deviation|Mean
79464|NCT01005745|Secondary|Number of Participants With Objective Response (OR)|OR is defined as the patient being alive at Day 70 and tumor size evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response or partial response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Evaluations were made by computed tomography (CT) scan approximately 6 to 8 weeks after the cell infusion, or CT scan approximately 10 weeks after the cell infusion, or by clinical evaluation during the first 70 days.|Average of 10 Months Follow-up|All participants who completed treatment||participants|||Number
79465|NCT01005745|Primary|Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth|Feasibility was the primary endpoint of this trial, defined as a patient who can grow and expand T-cells: Number of participants with fragments cultured; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture and were cocultured with autologous or human leukocyte antigen (HLA)-matched tumor cells for interferon(IFN)-γ production; Number of participants with fragments that produced IFN-γ in response to autologous or HLA-matched tumor cells.|192 Days Post Surgical Resection|All participants||participants|||Number
79466|NCT01005732|Secondary|Compliance With Wearing Compression Garment|The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.|About 12 months (follow-up visit 5)|All Participants with available and evaluable data.||hours per day||Standard Deviation|Mean
79467|NCT01005732|Secondary|Clinical Appearance of Wound|"Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or no difference) that the indicated zone had the better appearance."|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.||Participants|||Number
79468|NCT01005732|Secondary|Thickness of Wound|Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3–5 cm.|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.||mm||Standard Deviation|Mean
79469|NCT01005732|Secondary|Color of Wound|A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L*a*b* color space was described by The Commission Internationale de I’Eclairage (CIE)(L=brightness [100=white,0=black], a=red-green[red=60,green=-60], b=yellow-blue[yellow=60,blue=-60])|Approximately12 months (follow-up visits 5)|All Participants with available and evaluable measurement.||color space parameter units|Participants|Standard Deviation|Mean
79470|NCT01005732|Secondary|Durometer (Hardness) of Wound|"A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in durometer units (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3–5 cm."|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.||durometer units||Standard Deviation|Mean
79471|NCT01005732|Primary|Pressure Under Compression Garment|Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ‘‘dose’’ was measured directly. Values reported are averaged over indicated visits.|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.||mm Hg||Standard Deviation|Mean
79472|NCT01005719|Secondary|Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing|"The earliest time during the first 4 hours after dosing that the median~pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.)"|Treatment dose to event on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Minutes||Full Range|Median
79473|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1||Treatment dose to 4-hours post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
79474|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1||Treatment dose to 24-hour post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
79475|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
79476|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
79506|NCT01005355|Secondary|Screen for the Development of Circulating Antibodies Against IMC-1121B (Immunogenicity)|Data presented are the number of participants with treatment emergent antibody positive.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.||participants|||Number
79478|NCT01005719|Secondary|Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7|The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed.|Treatment dose to 2-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Minutes||Full Range|Median
79479|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
79480|NCT01005719|Secondary|Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at~steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
79481|NCT01005719|Secondary|Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 4 for at least 12 hrs at~steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Participants|||Number
79482|NCT01005719|Secondary|Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7||Treatment dose to 24-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of Time||Full Range|Median
79483|NCT01005719|Secondary|Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of time||Full Range|Median
79484|NCT01005719|Secondary|Median 24-hr Intragastric pH on Day 7|The median intragastric pH values were recorded over a 24-hr period.|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||pH||Full Range|Median
79485|NCT01005719|Secondary|Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7||Treatment dose to 4 hours Post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||Percentage of time||Full Range|Median
79486|NCT01005719|Secondary|Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period|The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of study treatment, and did not have missing values.||Minutes||Full Range|Median
79487|NCT01005719|Secondary|The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||pH||Full Range|Median
79488|NCT01005719|Secondary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.||pH||Full Range|Median
79489|NCT01005719|Primary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 7|Participants who received at least one dose of study treatment, and did not have missing values.||pH||Full Range|Median
79490|NCT01005706|Primary|Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection|Number of Participants with Kidney Rejections|12 months|||participants|||Number
79491|NCT01005680|Other Pre-specified|Survival Without Toxicity (SWT)|SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.|Randomization to date of toxicity or date of death up to 34.6 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycles. Censored participants: PC=22, GC=10.||months||95% Confidence Interval|Median
79507|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour post-dose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79576|NCT01004874|Secondary|One and Two Year Overall Survival|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date.|One year and two years|Intent to treat||percentage of participants||95% Confidence Interval|Number
79492|NCT01005680|Other Pre-specified|Disease Control Rate (DCR)|DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who are not on concurrent systemic chemotherapy.||percentage of participants|||Number
79493|NCT01005680|Secondary|Risk/Benefit Ratio|Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.|Randomization to date of death from any cause up to 35.8 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycle.||ratio|||Number
79494|NCT01005680|Secondary|Tumor Response Rate|Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.|Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response-Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who were not on concurrent systemic chemotherapy.||percentage of participants|||Number
79495|NCT01005680|Secondary|Time to Treatment Failure (TtTF)|TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.|Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=85, GC=91.||months||95% Confidence Interval|Median
79496|NCT01005680|Secondary|Duration of Response (DoR)|DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions|Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned and who achieved CR or PR. Censored participants: PC=1, GC=0.||months||95% Confidence Interval|Median
79497|NCT01005680|Secondary|Time to Progressive Disease (TtPD)|TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.|Randomization to first date of PD up to 23.7 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=12, GC=19.||months||95% Confidence Interval|Median
79498|NCT01005680|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.|Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization|Intent-to-Treat: all randomized participants who are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=8, GC=10.||months||95% Confidence Interval|Median
79499|NCT01005680|Primary|Overall Survival (OS)|OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.|Randomization to date of death from any cause up to 35.8 months post-randomization|Intent-to-Treat: all participants and are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=37, GC=39.||months||95% Confidence Interval|Median
79508|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 1 and 2||Day 1 and Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
79509|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79510|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.||hours||Full Range|Median
79511|NCT01005355|Primary|IMC-1121B Pharmacokinetics - Area Under the Concentration (AUC) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79512|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohort 3 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
79513|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79514|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
79515|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79516|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
79517|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79518|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.||hours||Full Range|Median
79519|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79520|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) Versus Time Curve - Cohorts 1 and 2 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
79521|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.|||||
79522|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
79523|NCT01005355|Primary|Number of Participants With Drug-Related Adverse Events|Data presented are the number of participants who experienced adverse events (AE) of any grade, AE of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), serious adverse events (SAE) and AE resulting in death that was considered to be related to IMC-1121B (ramucirumab). A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.||participants|||Number
79524|NCT01005329|Secondary|Distant Failure|Will be estimated using the cumulative incidence method.|From registration to date of distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
79525|NCT01005329|Secondary|Pelvic Failure|Will be estimated using the cumulative incidence method.|From registration to date of pelvic failure or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
79526|NCT01005329|Secondary|Disease-free Survival|Will be estimated using the Kaplan-Meier method.|From registration to date of first failure or last follow-up. Analysis occurs after all patients have been potentially followed for one year.||||||
79530|NCT01005329|Primary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0|The rate of the acute specified AEs (adverse events) from previous Radiation Therapy Oncology Group (RTOG) trial 9708 (RT + cisplatin) was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.|From start of treatment to 90 days|||percentage of participants||90% Confidence Interval|Number
79531|NCT01005290|Secondary|Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period|Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.||mm Hg||Standard Deviation|Mean
79532|NCT01005290|Primary|Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.|Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.||mm Hg||Standard Deviation|Mean
79533|NCT01005251|Secondary|Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary~(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment|||Percent||Inter-Quartile Range|Median
79534|NCT01005251|Primary|Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary.~(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment|||Participants|||Number
79535|NCT01004939|Secondary|Duration From Start of Fondaparinux Therapy to HIT|For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only one participant developed HIT after receiving Fondaparinux; thus, rather than presenting median data, data are presented as the number of days from start of therapy to HIT.||days|||Number
79536|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy|The participant with HIT II was pretreated with LMWH; however, the serious adverse event of HIT II was documented after the participant switched to Fondaparinux treatment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79537|NCT01004939|Secondary|Number of Participants With Skin Changes Under Fondaparinux Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79538|NCT01004939|Secondary|Number of Participants With Bleedings Under Fondaparinux Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79539|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under Fondaparinux Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79540|NCT01004939|Secondary|Number of Participants With and Without Complications Under Fondaparinux Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79541|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to HIT||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=8 participants with non-missing data.||days||Full Range|Median
79542|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy|HIT II is characterized as a sudden decrease of thrombocyte count because of allergic response on heparin/platelet factor 4 (PF-4) complexes and is a severe and potentially fatal side effect of heparins. Usually, HIT occurs between Day 5 and Day 14 of exposure to UFH or LMWH.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79543|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy|Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.||participants|||Number
79544|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy|Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.||participants|||Number
79545|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to Skin Change|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=27 participants with non-missing data.||days||Full Range|Median
79546|NCT01004939|Secondary|Number of Participants With Skin Changes Under UFH/LMWH Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79547|NCT01004939|Secondary|Number of Participants With Bleedings Under UFH/LMWH Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79548|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under UFH/LMWH Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79549|NCT01004939|Secondary|Number of Participants With Complications Under UFH/LMWH Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79550|NCT01004939|Secondary|Duration of Hospitalizations Before, During, and After Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=3 participants (before Fondaparinux), n=5 participants (during Fondaparinux), and n=1 participant (after Fondaparinux) with non-missing data.||days||Full Range|Median
79551|NCT01004939|Secondary|Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=9 participants with non-missing data.||days||Full Range|Median
79552|NCT01004939|Secondary|Number of Participants Hospitalized Because of Thromboembolic Treatment|Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79553|NCT01004939|Primary|Number of Newborns With Abnormalities|No formal definition for abnormalities was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||newborns|Participants||Number
79554|NCT01004939|Primary|Number of Newborns Who Had a “Healthy” Postnatal Classification|A “healthy” documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins.||newborns|Participants||Number
79555|NCT01004939|Primary|Mean APGAR Score at 1, 5, and 10 Minutes After Birth|APGAR is a test performed by a doctor, midwife, or nurse at 1 and 5 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5-minute score assesses how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=26 (1 min) or n=27 (5 and 10 min) newborns with non-missing data.||scores on a scale|Participants|Standard Deviation|Mean
79556|NCT01004939|Primary|Mean Head Circumference of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=27 newborns with non-missing data.||centimeters|Participants|Standard Deviation|Mean
79557|NCT01004939|Primary|Mean Height of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=37 newborns with non-missing data.||centimeters|Participants|Standard Deviation|Mean
79558|NCT01004939|Primary|Mean Weight of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=63 newborns with non-missing data.||grams|Participants|Standard Deviation|Mean
79559|NCT01004939|Primary|Number of Participants Who Delivered a Single Child Versus Twins||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79560|NCT01004939|Primary|Number of Participants With the Indicated Type of Conception/Fertilization||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79561|NCT01004939|Primary|Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79562|NCT01004939|Primary|Number of Participants With the Indicated Reason for the End of Fondaparinux Administration|It is possible that a participant stopped receiving Fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79563|NCT01004939|Primary|Number of Hours After Birth at Which Fondaparinux Administration Was Restarted||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=86 participants with non-missing data.||hours||Standard Deviation|Mean
79564|NCT01004939|Primary|Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=45 participants with non-missing data.||hours||Standard Deviation|Mean
79565|NCT01004939|Primary|Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79566|NCT01004939|Primary|Duration of Postnatal Fondaparinux Administration|The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=90 participants with non-missing data.||days||Full Range|Median
79567|NCT01004939|Primary|Duration of Prenatal Fondaparinux Administration|The prenatal interval is defined as the interval of time until 3 days before birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=99 participants with non-missing data.||days||Full Range|Median
79568|NCT01004939|Primary|Duration of Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=101 participants with non-missing data.||days||Full Range|Median
79569|NCT01004939|Primary|Number of Participants Administered the Indicated Dose of Fondaparinux Per Day||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79570|NCT01004939|Primary|Number of Participants With the Indicated Reason for Change to Fondaparinux|It was possible for a participant to have changed to fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79571|NCT01004939|Primary|Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals|The prenatal interval is defined as the interval of time until 3 days before birth. The perinatal interval is defined as the interval of time from 2 days before birth to one day after birth. The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010||participants|||Number
79572|NCT01004874|Secondary|Median Progression-free Survival|PFS was defined as time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat||months||95% Confidence Interval|Median
79573|NCT01004874|Secondary|Number of Patients Experiencing a Greater Than or Equal to Grade 4 Hematologic or a Greater Than or Equal to Grade 3 Non-hematologic Toxicity|Number of times a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity was experienced|27 months|Intent to treat||participants|||Number
79574|NCT01004874|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|27 months|Intent to treat||participants|||Number
79610|NCT01004770|Primary|Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values|Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.|Baseline and up to and including 8 hours post contrast administration|Per Study Protocol||> 10 beats per minute (bpm)||Standard Deviation|Mean
79577|NCT01004874|Primary|6-month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
79578|NCT01004848|Secondary|Knowledge & Attitudes About Diabetes Risk||6 months||||||
79579|NCT01004848|Secondary|Physical Activity (Self-report)||6 months||||||
79580|NCT01004848|Secondary|Fiber Intake||Change from Baseline to 6 Months|||grams per day||Standard Deviation|Mean
79581|NCT01004848|Secondary|Energy Expenditure|percent energy expenditure|Change from Baseline to 6 Months|||percent expenditure/day||Standard Deviation|Mean
79582|NCT01004848|Secondary|HbA1c||Change from Baseline to 6 Months|||percent change||Standard Deviation|Mean
79583|NCT01004848|Secondary|Triglycerides||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
79584|NCT01004848|Secondary|Total Cholesterol||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
79585|NCT01004848|Secondary|HDL Cholesterol||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
79586|NCT01004848|Secondary|LDL Cholesterol||Change from Baseline to 6 Months|||mg/dl||Standard Deviation|Mean
79587|NCT01004848|Secondary|Waist Circumference||Change from Baseline to 6 Months|||inches||Standard Deviation|Mean
79588|NCT01004848|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months|||mmHg||Standard Deviation|Mean
79589|NCT01004848|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months|||mmHg||Standard Deviation|Mean
79590|NCT01004848|Secondary|Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months|Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline|Change in 6 Months from Baseline|||mg/dL||Standard Deviation|Mean
79591|NCT01004848|Secondary|Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months|Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline|Change from Baseline to 6 Months|||mg/dL||Standard Deviation|Mean
79592|NCT01004848|Primary|Change in Weight From Baseline to 6 Months||Change from Baseline to 6 Months|||pounds||Standard Deviation|Mean
79593|NCT01004822|Secondary|Participants With Reduction in Tumor Vascular Permeability: Blood Flow and Blood Volume as Measured by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI is a non-invasive method that provides a functional assessment of microvasculature. The technique can measure changes in vascular permeability, extracellular, and extravascular and vascular volumes. Based on its ability to detect vascular changes, DCE-MRI has recently been evaluated as a biomarker of drug efficacy in clinical trials of angiogenesis inhibitors. Assessment of DCE-MRI started at the 3.0 mg/kg dose cohort.|Stage 2 predose up to end of study|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.|||||
79594|NCT01004822|Secondary|Participants WithTumor Response of CA-125 Epithelial Ovarian Cancer (EOC)/ Primary Peritoneal Cancer (PPC)|Participants with epithelial ovarian cancer or primary peritoneal cancer having CA-125 levels greater than 2x the upper limit of normal, 2 weeks prior to starting therapy were evaluated for CA-125 response and response is defined as a 50% decrease in CA-125 from a pre-treatment sample. The response was confirmed and maintained for at least 28 days. CA-125 response was calculated as intervening samples and the 28-day confirmatory sample must be less than or equal to (within assay variability of 10%) the previous sample Progression or recurrence based on serum CA-125 is defined according to the participants baseline levels.|Stage 2 every cycle|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.|||||
79595|NCT01004822|Secondary|Objective Response Rate - Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and Progressive Disease.|Every 8 weeks from start of treatment until last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||percentage of participants|||Number
79596|NCT01004822|Secondary|Number of Anti Drug Antibody Samples With Positive Anti-CVX-241 Antibodies|Results were summarized for overall study population as per planned analysis.|Day 1 pre-dose of each cycle up to last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||samples|||Number
79597|NCT01004822|Secondary|Change From Baseline in Serum Angiopoietin-2 (Ang2) Concentrations|Angiopoietin-2 (Ang2) and a related protein, angiopoietin-1 (Ang1) are ligands of the endothelial cell receptor Tie-2, a receptor tyrosine kinase, and are known to mediate the angiogenesis process together with VEGF and other angiogenic regulators. Ang1 stimulates the phosporylation of Tie-2, recruits pericytes to newly formed blood vessels, and promotes their maturation. Ang2 competes with Ang1 for binding of Tie-2, promotes the dissociation of pericytes, and results in unstable blood vessels. In the presence of VEGF and other angiogenic factors, endothelial cells in these unstable vessels proliferate and migrate to form new blood vessels.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||pg/mL||Standard Deviation|Mean
79611|NCT01004770|Primary|Vital Signs (Blood Pressure) Systolic and Diastolic Values|Systolic and Diastolic bolld pressure taken up to and including 8 hours|Baseline and up to and including 8 hours post contrast administation.|Per Study Protocol||mm Hg||Standard Deviation|Mean
79598|NCT01004822|Secondary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentrations|VEGF family consists of five glycoproteins known as VEGF-A, -B, -C, and -D, and placental growth factor (PlGF), which bind to three structurally similar receptor tyrosine kinases VEGFR1, VEGFR2, and VEGFR3. The different ligands have distinctive binding specificities for each of the receptors. In response to ligand binding, the VEGFRs activate distinct downstream signalling pathways. VEGFR2 is expressed in the vasculature and is the key mediator of VEGF-induced angiogenesis.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||picogram/milliliter (pg/mL)||Standard Deviation|Mean
79599|NCT01004822|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||hours||Standard Deviation|Mean
79600|NCT01004822|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Due to premature termination of the study, only certain exposure-related noncompartmental PK parameters were calculated.|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study, CL data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.|||||
79601|NCT01004822|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study Cmin data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.|||||
79602|NCT01004822|Secondary|Maximum Observed Plasma Concentration (Cmax)|Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
79603|NCT01004822|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞)u for unbound drug. It is obtained from AUC (0 - t)u plus AUC (t - ∞)u for unbound drug. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|"Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
79604|NCT01004822|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs and non-SAEs that occurred during the study.|Baseline up to 28 days after last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Data for Stage 2 is not reported due to early termination of the study.||participants|||Number
79605|NCT01004822|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Week 4|Safety analysis set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
79606|NCT01004822|Primary|Recommended Phase 2 Dose (RP2D)|RP2D was the highest dose where 0 of 3 or less than (<2) out of 6 participants experience a DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study RP2D could not be assessed.|||||
79607|NCT01004822|Primary|Maximum Tolerated Dose (MTD)|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study MTD could not be assessed.|||||
79608|NCT01004770|Primary|Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image|Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase|Pre and post contrast administration|Per Study Protocol||Hounsfield Units||Standard Deviation|Mean
79609|NCT01004770|Primary|12-Lead Electrocardiogram (ECG) Values|12-Lead ECG values taken up to and including 24 hours|Baseline and up to and including 24 hours post contrast administration|Per Study Protocol||QTcB (msec)||Standard Deviation|Mean
79613|NCT01004705|Secondary|The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population||mg/dL||Standard Deviation|Mean
79614|NCT01004705|Primary|The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population||mg/dL||Standard Deviation|Mean
79615|NCT01004614|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||hour||Full Range|Median
79616|NCT01004614|Secondary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||hour||Standard Deviation|Mean
79617|NCT01004614|Secondary|Apparent Terminal Elimination Half-Life (T-half)|Terminal phase half-life calculated as ln(2) / kel|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||hour||Standard Deviation|Mean
79618|NCT01004614|Secondary|Apparent Terminal Elimination Phase Rate Constant (Kel)|Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||L/h||Standard Deviation|Mean
79619|NCT01004614|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)|"AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.~AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration."|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||ng*h/mL||Standard Deviation|Mean
79620|NCT01004614|Primary|Maximum Observed Plasma Concentration (Cmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||ng/mL||Standard Deviation|Mean
79621|NCT01004614|Primary|Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)|Area under the concentration-time curve from zero time until the last sampling time|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.||ng*h/mL||Standard Deviation|Mean
79622|NCT01004510|Primary|Rate of Control (Lack of Need for Palliative Intervention of Malignant Pleural Effusions) in Patients With Non Small Cell Lung Cancer Treated With Standard Regimens of Cytotoxic Chemotherapy With the Addition of Zometa||3 months|Too few patients enrolled to analyze data|||||
79623|NCT01004432|Secondary|Change in ESR-based DAS28 Score at Week 76 Relative to Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.|Week 52, 76|Study extension mITT population. Here 'N' (number of participants analyzed) = participants evaluable for this measure and ‘n’ = participants evaluable at specified time point for each arm, respectively. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).||units on a scale||Standard Deviation|Mean
79624|NCT01004432|Secondary|Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.|Week 76|Study extension mITT population included all participants, who were enrolled into the 24-week study extension period at Week 52, and received at least 1 golimumab SC injection during the study extension period. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).||percentage of participants||95% Confidence Interval|Number
79641|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
80519|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
79625|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.|Week 52|Double-blind modified Intent To Treat (mITT) population included participants who were randomized at Week 16 to SC or IV golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization.||percentage of participants||95% Confidence Interval|Number
79626|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.|Week 52|Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label golimumab 50 mg SC injection during the continued open-label/ double-blind treatment period.||percentage of participants||95% Confidence Interval|Number
79627|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant’s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Within 2 weeks of initiating therapy|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
79628|NCT01004432|Primary|Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant’s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Week 14|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
79629|NCT01004393|Secondary|Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
79630|NCT01004393|Secondary|Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
79631|NCT01004393|Secondary|Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
79632|NCT01004393|Secondary|Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||units on a scale||Standard Deviation|Mean
79633|NCT01004393|Secondary|Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||units on a scale||Standard Deviation|Mean
79634|NCT01004393|Secondary|Time to Laxation After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone|||hours||Standard Error|Mean
79635|NCT01004393|Secondary|Laxation After Administration of Subcutaneous Methylnaltrexone||24 and 48 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
79636|NCT01004393|Primary|Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone||4 hours after the dose of subcutaneous methylnaltrexone|||percentage of participants||95% Confidence Interval|Number
79637|NCT01004354|Secondary|Changes in Serum Levels of Adiponectin, Leptin, and C-reactive Protein.||8 weeks||||||
79638|NCT01004354|Secondary|Changes in the Baseline and Post-treatment Values of the Markers of the Metabolic Syndrome (Insulin, C-peptide, Fasting Blood Glucose, Homeostasis Model of Insulin Resistance (HOMA-IR), High Density Lipoprotein Cholesterol).||8 weeks||||||
79639|NCT01004354|Primary|Change in Weight||Baseline and 8 weeks|||kilograms||Standard Deviation|Mean
79640|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
79642|NCT01004263|Secondary|Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated.|2 hours post dose|All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation||percentage of participant's attacks||Standard Deviation|Mean
79643|NCT01004263|Primary|Number of Participants With AEs Within 14 Days Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
79644|NCT01004263|Primary|Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication||participants|||Number
79645|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"||Percentage of Participants||95% Confidence Interval|Number
79646|NCT01004250|Secondary|Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"||Percentage of Participants||95% Confidence Interval|Number
79647|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)|Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"||Percentage of Participants||95% Confidence Interval|Number
79648|NCT01004250|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.|From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)|32 participants were censored. All enrolled participants receiving at least one dose of study drug.||Months||95% Confidence Interval|Median
79649|NCT01004250|Primary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.|From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)|"30 participants were censored. Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"||Months||90% Confidence Interval|Median
79650|NCT01004185|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.|Week 26|mITT Subjects who took at least one dose of study medication and did not have baseline stool examination positive for C. difficile, bacterial pathogens or ova/parasites.||percentage of participants|||Number
79651|NCT01004185|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.|Week 26|MITT subjects who took at least one dose of study medication and did not have baseline stool exam positive for C. difficile, bacterial pathogens or ova/parasites.||percentage of participants|||Number
79652|NCT01004159|Secondary|Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population||18 months|All treated and eligible patients||percentage of particitpants||95% Confidence Interval|Number
79653|NCT01004159|Primary|12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer||12 week|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
79654|NCT01004146|Secondary|Respiratory Rate||one week prior to surgery to post operative day 1||||||
79655|NCT01004146|Secondary|Heart Rate||one week prior to surgery to post operative day 1||||||
79656|NCT01004146|Secondary|Oxygen Saturation||one week prior to surgery up to one day after||||||
79657|NCT01004146|Secondary|Level of Compliance||3 days to 2 weeks after clinic visit on the day of surgery||||||
79658|NCT01004146|Primary|Post Operative Incentive Spirometry Volume|After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.|1 week before surgery to the day after|||cc||Standard Deviation|Mean
79659|NCT01004003|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants||months||Inter-Quartile Range|Median
79660|NCT01004003|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants||months||Inter-Quartile Range|Median
79661|NCT01004003|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.~95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, phase II participants only||percentage of participants||95% Confidence Interval|Number
79662|NCT01004003|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).||participants|||Number
79663|NCT01004003|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants.||months||Inter-Quartile Range|Median
79664|NCT01004003|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set which included all patients who received at least one single dose of trial medication, including phase I patients from the dose escalation part that were not replaced for MTD determination.||mg bid|||Number
79665|NCT01003938|Secondary|Toxicity Profile|"Number of participants (patients) who experienced AEs.~Dry skin, dry eye, acne, erythema, rash, pruritus, and diarrhea were related erlotinib; dehydration, anemia, leukopenia, nausea, vomiting, platelets, and fatigue were realted to topotcan."|the whole treatment phase and 30 days post-treatment|||participants|||Number
79666|NCT01003938|Secondary|Overall Survival|estimated total time from the start of the trial|4 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
79667|NCT01003938|Secondary|Time to Progression|Time to progression is defined as the time from first study drug administration until the first day radiological and /or symptomatic disease progression is documented, or until death in the absence of progression.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
79668|NCT01003938|Secondary|CA125 Stable Disease Duration|Stable disease (SD) duration is measured from the tile of start of therapy until the criteria for progression are met. SD: CA125 decreases <50% or increases <100%. Disease progression: CA125 doubles the value of baseline, or more, over time.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
79691|NCT01002742|Secondary|Overall GVHD-free Survival Post-randomization||Months 6 and 12|||percentage of participants||95% Confidence Interval|Number
79692|NCT01002742|Secondary|Incidence of Topical/Non-absorbable Therapy||Day 56|||participants|||Number
79669|NCT01003938|Secondary|CA125 Response Duration|Response duration is measured from the time measurement criteria for CA125 CR/PR at the first met until the first date that recurrent or progressive disease is objectively documented.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.|||||
79670|NCT01003938|Primary|CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib|Response was assessed after every treatment cycle. Response rate is defined as number of the patients who experienced complete or partial CA125 response (CR or PR). CR: normalization of the CA125 value, determined by 2 observations not less than 4 weeks apart; PR: CA125 decreases by >50% and is confirmed to be 50% or greater on a subsequent determination at least one month later.|Up to 3 years|||participants|||Number
79671|NCT01003899|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Baseline till progression or death||||||
79672|NCT01003899|Secondary|Time to OR|The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.|Baseline till progression or death||||||
79673|NCT01003899|Secondary|Duration of Disease Control (DC)|Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).|Baseline till progression or death|FAS - Full Analysis Set||weeks||Full Range|Median
79674|NCT01003899|Secondary|Progression Free Survival (PFS) Time|PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death|Baseline till end of study or death|FAS - Full Analysis Set||Weeks||95% Confidence Interval|Median
79675|NCT01003899|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.|Baseline till progression or death|FAS - Full Analysis Set||Percentage of participants||95% Confidence Interval|Number
79676|NCT01003899|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).|Baseline till progression or death|FAS (Full Analysis Set). The FAS consisted of all treated patients, excluding any patients found not be EGFR mutation negative according to central laboratory testing.||Percentage of participants||95% Confidence Interval|Number
79677|NCT01003886|Secondary|Percentage of Participants With Postural Hypotension|Postural or orthostatic hypotension is a medical condition where blood pressure falls rapidly after the body changes position most commonly occurring after standing up after sitting for long periods of time.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.||Percentage of participants|||Number
79678|NCT01003886|Secondary|Change From Baseline in Diastolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||mmHg||Standard Deviation|Mean
79679|NCT01003886|Secondary|Change From Baseline in Systolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||mmHg||Standard Deviation|Mean
79680|NCT01003886|Secondary|Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12|The IPSS QoL Score is obtained by assessment of a single QoL question on a 7-point likert scale which was scored on a scale of 0-6 where 0 = best possible score to 6 = worst possible score.|Baseline, Week 4 and Week 12|FAS population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the LOCF. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Units on a scale||Standard Deviation|Mean
79681|NCT01003886|Secondary|Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12|The IPSS total score is obtained by combining the scores of the responses to 1 through 7 component questions all of which were on a 6 point likert scale. Each question is scored from 0-5 for an IPSS range of 0-35 points where 0 = best possible score to 35 = worst possible score.|Baseline, Week 4 and Week 12|Full analysis set (FAS) population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the last observation carried forward (LOCF). The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Units on a scale||Standard Deviation|Mean
79682|NCT01003886|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.||Participants|||Number
79683|NCT01002742|Secondary|Change in Patient Reported Outcomes From Enrollment to Day 56||Day 56|No data collected|||||
79684|NCT01002742|Secondary|Treatment Related Mortality (TRM)||Year 1|||percentage of participants||95% Confidence Interval|Number
79685|NCT01002742|Secondary|Disease-Free Survival (DFS) Post-Randomization|DFS includes death or progression/relapse of malignancy|Year 1|||percentage of participants||95% Confidence Interval|Number
79686|NCT01002742|Secondary|Cumulative Incidence of a Severe/Life-threatening/Fatal Infections||Year 1|||percentage of participants||95% Confidence Interval|Number
79687|NCT01002742|Secondary|Incidence of Cytomegalovirus (CMV) Reactivation||Year 1|||percentage of participants|||Number
79688|NCT01002742|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||12 months|||participants|||Number
79689|NCT01002742|Secondary|Incidence of Systemic Infections|Number of participants that experienced at least one infection.|6 Months|||participants|||Number
79690|NCT01002742|Secondary|Incidence of Chronic GVHD||12 months post-randomization|||percentage of participants||95% Confidence Interval|Number
79693|NCT01002742|Secondary|Cumulative Steroid Dose|The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week’s dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared.|Days 28 and 56|||mg/kg|||Number
79694|NCT01002742|Secondary|Incidence of Discontinuation of Immune Suppression Without Flare||Day 56, Day 180 and Day 360 post-treatment|No data collected|||||
79695|NCT01002742|Secondary|Incidence of GVHD Flares Requiring Increased Therapy|Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy.|Day 90|||participants|||Number
79696|NCT01002742|Secondary|Percentage of Surviving Participants With Complete Response (CR)|CR is defined as a score of 0 for the GVHD grading in all evaluable organs.|Days 14, 28, and 56|||percentage of participants|||Number
79697|NCT01002742|Primary|GVHD-free Survival|Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure.|Day 56|||participants|||Number
79698|NCT01003301|Primary|The the Size of the 8 Late-phase Skin Response|Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.|Baseline, 2-6 wks|||percentage decline from NAC-1||Standard Deviation|Mean
79699|NCT01003288|Secondary|Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay|Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response|7, 14, 21 days post vaccination and long term follow up for 5 years|Only HCW 251 were assessed for HI antibodies at 21 days post vaccination||participants|||Number
79700|NCT01003288|Primary|Number of Participants With Local and Systemic Adverse Events|Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.|21 days after vaccination|solicited adverse event forms were collected from the volunteers||participants|||Number
79701|NCT01003275|Primary|Glucose Area Under the Curve (AUC)|Glucose AUC during a 2-hour oral glucose tolerance test|8 weeks|||mg*min/dL||Geometric Coefficient of Variation|Geometric Mean
79702|NCT01003210|Secondary|Side Effects From Study Remedy|"Any other symptoms reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone."|15 days|The number of participants analyzed includes only those whose parents returned logbooks.||participants|||Number
79703|NCT01003210|Primary|Administration of Antibiotics|Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.|15 days|||participants|||Number
79704|NCT01003210|Primary|Severity of Symptoms of Otitis Media||15 days||||||
79705|NCT01003184|Secondary|Hypoglycemia Rate Per Year|All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.|Baseline, Week 26|Full analysis set (as randomized).||events per subject-year||95% Confidence Interval|Number
79706|NCT01003184|Secondary|Change in Triglycerides From Baseline to Endpoint (Week 26).|Change in triglycerides from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.||mmol/L||Standard Error|Least Squares Mean
79707|NCT01003184|Secondary|Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).|Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.||mmol/L||Standard Error|Least Squares Mean
79708|NCT01003184|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26).|Change in total cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).~The last observation carried forward (LOCF) of post baseline values was used for this analysis."||mmol/L||Standard Error|Least Squares Mean
79709|NCT01003184|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in diastolic blood pressure from baseline to week 26.|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||mmHg||Standard Error|Least Squares Mean
79710|NCT01003184|Secondary|Changes in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline to Week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).||mmHg||Standard Error|Least Squares Mean
79711|NCT01003184|Secondary|Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).|Change in fasting serum glucose from baseline to endpoint (Week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).~The last observation carried forward (LOCF) of post baseline values was used for this analysis."||mmol/L||Standard Error|Least Squares Mean
79712|NCT01003184|Secondary|Percentage of Patients Achieving ≤6.5% at Endpoint|Percentage of patients achieving HbA1c ≤6.5% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.||Percentage||95% Confidence Interval|Number
79713|NCT01003184|Secondary|Percentage of Patients Achieving ≤7.0% at Endpoint|Percentage of patients achieving ≤7.0% at endpoint.|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.||Percentage||95% Confidence Interval|Number
79714|NCT01003184|Secondary|Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint|Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.||Percentage||95% Confidence Interval|Number
79717|NCT01003184|Secondary|Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)|Baseline, Week 26|The analysis was done for the FAS population (as randomised). For secondary analyses including both final HbA1c concentration and change in weight the last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value.||Percentage||95% Confidence Interval|Number
79718|NCT01003184|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.|Baseline, Week 26|The full analysis set (FAS) includes all data from all randomised patients receiving at least one dose of the study drug according to the treatment the patients were assigned.||Percentage||95% Confidence Interval|Number
79719|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36|||microns||Standard Error|Mean
79720|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6|||microns||Standard Error|Mean
79721|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36|||Letters||Standard Error|Mean
79722|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6|||Letters||Standard Error|Mean
79723|NCT01003106|Primary|Incidence and Severity of Ocular and Non-ocular Adverse Events.||36 months|||participants|||Number
79724|NCT01003080|Secondary|Change in Hemoglobin and Hematocrit.||First three days after surgery.||||||
79725|NCT01003080|Primary|Drain Output.|This is a measure of the average drain output collected in the first 24 hours following surgery.|First 24 hours following surgery.|||mL||Standard Deviation|Mean
79726|NCT01002989|Primary|Mean Watch BP Office Ankle-Brachial Index||once (cross-sectional)|||ratio||Standard Deviation|Mean
79727|NCT01002989|Primary|Mean Doppler Ankle-Brachial Index||once (cross-sectional)|||ratio||Standard Deviation|Mean
79728|NCT01002989|Secondary|Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis|This outcome measure represents what percentage of the patients diagnosed with PAD using Doppler ABI method (reference method) were diagnosed with PAD using WatchBP Office ABI method. It also represents in what percentage of the patients in whom PAD was excluded with Doppler ABI method (reference method), PAD was excluded using WatchBP Office ABI method as well.|Once (cross-sectional)|||Percentage of participants|||Number
79729|NCT01002989|Primary|Watch BP Office Minus Doppler Ankle-Brachial Index Difference|The validation process consisted of two parts: (i) measurement validation, which compared Doppler and Watch BP Office ABI values and assessed their association, and (ii) clinical validation, which compared the diagnosis of peripheral artery disease (PAD) by the two methods and assessed the association of Watch BP Office and Doppler ABI values with cardiovascular risk factors.|once (cross-sectional)|Patients with various cardiovascular risk factors attending a hypertension or a diabetes outpatient clinic were invited to participate in the study. Subjects with atrial fibrillation or incompressible ankle arteries (ABI ≥1.4) were excluded.||ratio||Standard Deviation|Mean
79730|NCT01002573|Secondary|Number of Afebrile and Febrile Subject at 4 Hours Post-Dose|Number of Afebrile and Febrile Subject at 4 Hours Following Treatment|4 Hours Post-Dose|Some participants data was not included in the analysis due to having too few/insufficient data||participants|||Number
79731|NCT01002573|Secondary|Time to Afebrility (in Hours)|Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.|4 Hour post treatment|||Hours||Standard Deviation|Mean
79732|NCT01002573|Secondary|Change From Baseline in Temperature After the First Four Hours of Treatment|Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)|0 to 4 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data||degree Celsius*Time||Standard Deviation|Mean
79733|NCT01002573|Secondary|Change in Temperature|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.|4 hours following treatment|Some participants data was not included in the analysis due to having too few/insufficient data||Celsius||Standard Deviation|Mean
79734|NCT01002573|Secondary|Change From Baseline in Temperature After the First 60 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.|60 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data||Celsius||Standard Deviation|Mean
79735|NCT01002573|Secondary|Change From Baseline in Temperature After the First 30 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.|30 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data||Celsius||Standard Deviation|Mean
79736|NCT01002573|Primary|Fever Reduction|Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)|0 to 2 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data||degree Celsius*Time||Standard Deviation|Mean
79737|NCT01002482|Secondary|Incidence of Nosocomial Bacteriemia||Date of discharge from the ICU||||||
79738|NCT01002482|Secondary|Intensive Care Unit Length of Stay||Date of discharge from the ICU|||days||Inter-Quartile Range|Median
79739|NCT01002482|Secondary|Hospital Length of Stay||Date of discharge from the hospital|||days||Inter-Quartile Range|Median
79742|NCT01002482|Secondary|Intensive Care Unit Free Days|Intensive care unit free days was 28-day-ICU-free-days i.e. was calculated by subtracting the actual ICU duration in days from 28 with patients who died at day 28 or before being assigned 0 free-days and those who had a stay in ICU of 28 days or more being also assigned 0 free-days|28 days|||days||Inter-Quartile Range|Median
79743|NCT01002482|Secondary|All-cause In-hospital Mortality||Day of discharge from the hospital|||participants|||Number
79744|NCT01002482|Secondary|All-cause Intensive Care Unit Mortality||Date of discharge from the ICU|||participants|||Number
79745|NCT01002482|Secondary|All-cause 28-day Mortality||Day 28|||participants|||Number
79746|NCT01002482|Primary|All-cause 90-day Mortality||Day 90|||participants|||Number
79747|NCT01002456|Secondary|Progress Toward Adherence to Guideline Prescription|either change to a guideline agent or dose increase of a guideline agent|6 months|||patients|||Number
79748|NCT01002456|Primary|Rate of Adherence to Guideline Prescription|full adherence to guideline medication and dose|6 months|||patients|||Number
79749|NCT01002339|Secondary|Percentage of Patients Using Acetylsalicylic Acid (ASA)||1 year|Analysis population description: participants living with a functioning graft at study end.||percentage of participants||95% Confidence Interval|Number
79750|NCT01002339|Secondary|Changes of Carotid Intima-media Thickness Over Time|absolute difference between carotid intima-media thickness at study end versus baseline.|1 year|Participants analyzed: participants living with a functioning graft at study end.||mm|Participants|95% Confidence Interval|Mean
79751|NCT01002339|Secondary|Percentage of Patients Using Statins||1 year|Participants analyzed: participants living with a functioning graft at study end.||percentage of participants||95% Confidence Interval|Number
79752|NCT01002339|Secondary|Lipidic Profile (LDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl|Participants|Standard Deviation|Mean
79753|NCT01002339|Secondary|Lipidic Profile (HDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl|Participants|Standard Deviation|Mean
79754|NCT01002339|Secondary|Lipidic Profile (Cholesterol)|Lipidic Profile (total cholesterol)|1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl|Participants|Standard Deviation|Mean
79755|NCT01002339|Secondary|Lipidic Profile (Triglycerides)||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/dl|Participants|Standard Deviation|Mean
79756|NCT01002339|Secondary|Number of Antihypertensive Drugs Patients Reported Taking.||1 year|Participants analyzed: participants living with a functioning graft at study end.||number of antihypertensive drugs||Inter-Quartile Range|Median
79757|NCT01002339|Secondary|Blood Pressure|Diastolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.||mmHg|Participants|Standard Deviation|Mean
79758|NCT01002339|Secondary|Blood Pressure|Systolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.||mmHg|Participants|Standard Deviation|Mean
79759|NCT01002339|Secondary|Proteinuria||1 year|Participants analyzed: participants living with a functioning graft at study end.||mg/day|Participants|95% Confidence Interval|Mean
79760|NCT01002339|Secondary|Renal Function|Estimated Glomerular Filtration Rate (ml/min/1.73 m^2)|1 year|Participants analyzed: Participants living with a functioning graft at study end.||ml/min/1.73 m^2||95% Confidence Interval|Mean
79761|NCT01002339|Secondary|Rejection|Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.|1 year|||percentage of participants||95% Confidence Interval|Number
79762|NCT01002339|Primary|Primary Outcome Measure (Glucose Intolerance)|Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.|1 year|Participants included are those that did not develop NODAT based on not reporting the use of anti-diabetic drugs plus a fasting plasma glucose <126 mg/dl .||percentage of participants|Participants|95% Confidence Interval|Number
79763|NCT01002339|Primary|Patients Treated With Insulin or Oral Antidiabetic Drugs||1 year|Participant analyzed: participants living with a functioning graft at study end.||percentage of participants||95% Confidence Interval|Number
79764|NCT01002339|Primary|"Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)"|American Diabetes Association criteria (ADA) including an oral glucose tolerance test.|1 year|Participants analyzed: participants living with a functioning graft at study end||percentage of participants||95% Confidence Interval|Number
79765|NCT01002287|Secondary|Mobilization Time|The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.|average 10-12 weeks post surgery|All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan.||minutes||Standard Deviation|Mean
79766|NCT01002287|Secondary|Adhesion Involvement Along the Midline Incision (Percentage)|The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.|average 10-12 weeks post surgery|These patients must have values for length of the incision associated with adhesions (cm) and for length of initial midline incision (cm) in order to calculate Extent of Adhesion Involvement (%). NOTE: Extent of Adhesion Involvement (%) = length of the incision associated with adhesions (cm) / length of initial midline incision (cm) * 100.||percentage of midline incision||Standard Deviation|Mean
79767|NCT01002287|Secondary|Severity of Adhesions|Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are “1”, “2”, and “3”. Subjects without adhesions were assigned a severity rating of “0”.|Average 10-12 weeks post surgery|All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan.||units on a scale||Standard Deviation|Mean
79768|NCT01002287|Primary|The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.||10-12 Weeks post Initial Surgery for J-Pouch|All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.||percentage of subjects with adhesions|||Number
79769|NCT01002105|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report form composed of 16 items, each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction with: physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; and living/housing situation. A total score of 1 to 15 items was computed while item 16 assessing overall life satisfaction was not included to avoid exaggerated scores. The total score was averaged from items 1 to 15 and ranged from 1 to 5, with higher scores indicating higher satisfaction."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
79770|NCT01002105|Secondary|Multidimensional Scale of Perceived Social Support|The MSPSS is a self-report instrument for assessment of emotional help and the level of satisfaction with the social support obtained from three sources - family, friends and significant others. The scale includes 12 items, each of which refer to the people to whom the respondent would turn if he/she had problems of a personal, health or family nature, as well as financial and employment problems. Responses are scored on a 7-point scale from 1 ('completely disagree') to 7 ('completely agree'). The MSPSS index and three subscales – family, friends and significant others - are computed. MSPSS total score ranged from 12 to 84, with a higher score indicating greater satisfaction with total support. Subscores ranged from 4 to 28, with higher score indicating greater satisfaction.|Baseline, 52 weeks|||units on a scale||Standard Deviation|Mean
79771|NCT01002105|Secondary|General Self-Efficacy Scale|"The GSES measures one’s belief in his/her ability to cope with stressful situations. The scale consists of 10 items (e.g. Usually I am able to control a situation or In unexpected situations, I always know how I must behave myself). Responses are rated on a 4- point Likert-scale ranging from ”absolutely not true” (weighted as 1) to “absolutely true” (weighted as 4), where the higher GSES total scores indicate stronger self-efficacy beliefs.All responses are added to a sum score. The range is from 10 to 40 points with a higher score indicating more self-efficiency."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
79772|NCT01002105|Secondary|General Health Questionnaire|The General Health Questionnaire measures whether the respondent has recently experienced a particular symptom or behavior and ranges from 0-much less than usual to 3-much more than usual. Total scores range from 0 to 36 and vary by study population: total scores of about 11-12 are typical, and a score higher than 20 suggests severe problems and psychological distress.|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
79773|NCT01002105|Secondary|Obsessive-Compulsive Drinking Scale Scores|Used to evaluate self-reported alcohol craving. 14 items that provided a total (OCDS) as well as two subscale scores - obsessive drinking (OD) and compulsive drinking (CD). Each of the 14 items are scored from 0 to 4 with the inclusion of 4 split items with only the higher of the two scored items to be used in the total or subscale scores. The OCDS total score ranges from 0-40; the subscales both range from 0 to 20. On all scales, higher scores represent a worse outcome. Data for CD at 6 weeks not available to report|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks|||units on a scale||Standard Deviation|Mean
79774|NCT01002105|Primary|Percent Abstinent Days|Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.|one year|||percentage of abstinent days|||Number
79775|NCT01001975|Primary|Determination of Ultraviolet A Protection Factor (PFA)|Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).|2 to 4 hours post-exposure|Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA||Score on a scale||Standard Deviation|Mean
79776|NCT01001975|Primary|Determination of Sunscreen Protection Factor (SPF)|Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).|16 to 24 hours post-exposure|Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF||Score on a scale||Standard Deviation|Mean
79777|NCT01001832|Secondary|Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79778|NCT01001832|Primary|Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed.||units on a scale||95% Confidence Interval|Mean
86885|NCT00939107|Secondary|Number of Patients on Sick Leave|Measured by self-report of beeing on sick leave at the moment because of LBP|twelve months posttreatment|Number of patients on sick leave due to LBP pre-treatment.||Participants|||Number
79779|NCT01001832|Primary|Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period|The Health Assessment Questionnaire (HAQ) disability index assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The higher the number the worse the outcome. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. HAQ response=reduction of at least 0.30 units in HAQ score from baseline. The percentage of participants with a reduction of at least 0.30 units in their HAQ score from baseline is presented. Baseline is Day 1 of the study or last non-missing pre-treatment value. Treatment groups represent treatment received in the short term period.|Day 533|N=number of participants treated with at least 1 dose of study drug and with HAQ data available. n=number of participants with HAQ response. n/N = 41/52 and 31/51 in SC and IV arms, respectively. Treatment groups represent treatment received in the short term period.||percentage of participants||95% Confidence Interval|Number
79780|NCT01001832|Primary|Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period.||units on a scale||95% Confidence Interval|Mean
79781|NCT01001832|Primary|Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period|The ACR score indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score= a percentage. To qualify for a score of 20, 50 or 70 (ACR20, ACR50 or ACR70), the patient must have >=20%, >=50% or >=70%, respectively, fewer tender joints and >=20%, >=50% or >=70%, respectively, fewer swollen joints and show 20%, 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Treatment groups represent treatment received in the short term period. Percentage calculated as n/m with n=number of paticipants with sustained ACR response at Day 533; m= long term participants who received at least one dose of drug and were ACR responders in the short term period.|Day 533|m=Long term period participants who received at least one dose of drug and were ACR responders in short term period: ACR20= 49, 46; ACR50= 35, 34; ACR70= 20, 16. n=number of paticipants with sustained ACR response at Day 533. n/m = percentage||percentage of participants||95% Confidence Interval|Number
79782|NCT01001832|Secondary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; GGT (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79783|NCT01001832|Secondary|Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79784|NCT01001832|Secondary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. alkaline phosphatase (ALP) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; aspartate aminotransferase (AST) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; alanine aminotransferase(ALT) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; Gamma glutamyltransferase(GGT) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79785|NCT01001832|Secondary|Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79882|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Full Range|Median
79786|NCT01001832|Secondary|Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|lower limit of normal(LLN); upper limit of normal(ULN); pretreatment(preRX). Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79787|NCT01001832|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 533 and up to 56 days following last dose in Long-Term period|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79788|NCT01001832|Secondary|Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
79789|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period|EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP<2.6.|Day 533|m=All treated participants in the long term period in the analysis with available LDAS and REM data. n=number of participants with either EULAR-defined LDAS response or EULAR-defined REM response. n/m = percentage of participants||percentage of participants||95% Confidence Interval|Number
79790|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period|EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (<) 2.6.|Day 169|m=All randomized participants who received at least 1 dose of study medication and with LDAS and REM data available. n= number of participants with LDAS and REM. n/m=percentage of participants.||Percentage of participants||95% Confidence Interval|Number
79791|NCT01001832|Secondary|Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Baseline is Day 1 or last non-missing pre-treatment value.|Baseline to 6 Months|All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed.||Units on a scale||95% Confidence Interval|Mean
79792|NCT01001832|Secondary|Percentage of Participants With HAQ Response at Day 169 in the Short Term Period|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. The HAQ-DI response is defined as a reduction of at least 0.30 units in HAQ score from baseline.|Day 169|N=All randomized participants who received at least 1 dose of study medication in short term period. n=number of participants with HAQ response in short term period; n/N=percentage of participants: 41/59 and 30/59||Percentage of participants||95% Confidence Interval|Number
79793|NCT01001832|Secondary|Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3.|Baseline to Day 169|All participants who received at least 1 dose of study medication were analyzed.||Units on a scale||95% Confidence Interval|Mean
79803|NCT01001702|Secondary|Number of Participants With Clinical Significant Laboratory Tests|"Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.~Clinically significant values are defined as the following:~Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)].~Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.~Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)]."|Baseline, Up to 72 Months|Participants with at least one post-baseline numeric result for the given laboratory test are included in the analysis.||Participants|||Number
79794|NCT01001832|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period|The American College of Rheumatology (ACR) scores of 50 and 70 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score represents a percentage. To qualify for an ACR50 or ACR70 scores, the patient must have >=50% or >=70%, respectively, fewer tender joints and >=50% or >=70%, respectively, fewer swollen joints and show 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation).|Day 169|m= All participants who received at least 1 dose of study medication in short term period and had data available. n= participants with ACR50 or ACR70 response in the short term period. n/m= percentage||Percentage of participants||95% Confidence Interval|Number
79795|NCT01001832|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period|The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug.|Day 169|N= All randomized participants who received at least 1 dose of study medication and were analyzed. n=number of participants with ACR20 response at Day 169: 54, 49, respectively. n/N= percentage: 54/59; 49/59.||Percentage of participants||95% Confidence Interval|Number
79796|NCT01001806|Primary|Peak Aqueous Penetration||day 4 of treatment|Protocol specified enrollment of 126 subjects and analysis was performed per protocol.||ng/ml||Standard Deviation|Mean
79797|NCT01001767|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery|Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.|baseline and week 24|Randomized to have equal number in both groups||percent change||Standard Deviation|Mean
79798|NCT01001702|Secondary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.|Baseline, Up to 72 months|All participants with available assessment.||Participants|||Number
79799|NCT01001702|Secondary|Number of Participants Showing Significant Weight Gain or Loss|Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.||Participants|||Number
79800|NCT01001702|Secondary|Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations|"A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.~Clinically significant ECGs were defined as:~Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.~Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.~Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett’s formula), QTcF (QT interval corrected Fridericia’s formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline."|Baseline, Up to 72 months|Participants with at least one post-baseline numeric result for the given parameter.||Participants|||Number
79801|NCT01001702|Secondary|Number of Participants With Clinically Significant Blood Pressure|"Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.~Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.~A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline."|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.||Participants|||Number
79802|NCT01001702|Secondary|Number of Participants With Clinically Significant Heart Rate|Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.||Participants|||Number
79804|NCT01001702|Secondary|Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score|"The rater or investigator answered the following question:~Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement"|Baseline, Last Visit (Up to 72 Months)|Participants with baseline assessment and at least one post-baseline measurement for analysis.||Score on a scale||Standard Deviation|Mean
87333|NCT00934843|Secondary|Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery|Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery|at 36 hours and 30 days|||participants|||Number
79805|NCT01001702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths|"An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.~An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.~Additional information about Adverse Events can be found in the Adverse Event section."|Up to 72 months|Safety population included all participants who received at least one dose of study drug.||Participants|||Number
79806|NCT01001572|Secondary|Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
79807|NCT01001572|Secondary|Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
79808|NCT01001572|Secondary|Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint|The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
79809|NCT01001572|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.||mmHg||Standard Error|Least Squares Mean
79810|NCT01001572|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.||mmHg||Standard Error|Least Squares Mean
79811|NCT01001559|Secondary|Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications||60 days|||Alterations in antidepressant therapy|||Number
79812|NCT01001559|Secondary|Number of Hospitalizations Due to MDD|Number of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts|60 days|||Hospitalizations due to MDD|||Number
79813|NCT01001559|Secondary|Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient’s illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.~Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence."|60 days|All participants||Days||Inter-Quartile Range|Median
79814|NCT01001559|Primary|Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient’s illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.~Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline."|60 days|All participants||Participants|||Number
79815|NCT01001546|Primary|The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)||3 months post treatment|||percentage of participants|||Number
79828|NCT01001494|Secondary|Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Liters||Standard Error|Least Squares Mean
79829|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment||Baseline and Week 12|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Liters||Standard Error|Least Squares Mean
79816|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Ventromedial Prefrontal Cortex; vmPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
79817|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Posterior Cingulate Cortex; PCC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
79818|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Dorsal Cingulate/Medial Prefrontal Cortex; MF/CG)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
79819|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Left Dorsolateral Prefrontal Cortex; Left DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.||BOLD signal||Standard Error|Mean
79820|NCT01001520|Secondary|Subjective Symptoms: Withdrawal Symptoms|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales. The MNWS-N (right now/at the moment) was assessed during each fMRI scanning session visit (Day 8).~To assess if tolcapone (vs. placebo) affect withdrawal symptoms, we statistically analyzed the average of the total MNWS scores across, all 20 subjects, for each study medication period. Specifically, we analyzed for significant differences between reported withdrawal symptoms while taking tolcapone vs. taking placebo."|Day 8 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||units on a scale||Standard Deviation|Mean
79830|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Liters||Standard Error|Least Squares Mean
79831|NCT01001403|Primary|Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)|Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. “Moderate” PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a “severe” form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.|during 5 min after reperfusion of liver graft|||participants|||Number
79821|NCT01001520|Secondary|Subjective Symptoms: Cigarette Craving|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). Specifically, subjects completed the QSU-B at day 5, day 8 (fMRI scanning session 1), day 26 (day 5 of study medication period 2), and day 29 (day 8 of study medication period 2; fMRI scanning session 2).~The range of possible scores on the QSU-B is 10-70, with higher values indicating an increased craving for cigarettes. This range of scores represent a total score; there are no subscales.~While the QSU-B was collected at all in-person sessions, we only analyzed the scores collected from the fMRI scanning sessions of each period (day 8 and day 29). To analyze, we averaged the total scores across all 20 subjects from each fMRI scanning session and statistically analyzed for significant differences between these two averages. This was a within-subject analysis."|Day 8 (fMRI scanning session) of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects||units on a scale||Standard Deviation|Mean
79822|NCT01001520|Secondary|Subjective Symptoms: Smoking Behavior|In order to determine if tolcapone (vs. placebo) would affect subject smoking behavior, we collected the daily number of cigarettes each subject smoked from Days 1 through 7 during each study medication period. This allowed us to calculate the average number of daily cigarettes smoked, across all subjects, during each study medication period (i.e., the average number of cigarettes/day smoked while all subjects took tolcapone and the average number of cigarettes/day smoked while all subjects took placebo). Then, we statistically assessed if there was a significant difference between these averages.|Days 1 through 7 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||Average number of cigarettes smoked/day||Standard Deviation|Mean
79823|NCT01001520|Secondary|Cognitive Performance: Reaction Time|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.~Specifically, we tested whether subjects, while taking tolcapone, would display increased average reaction time (in milliseconds) during the N-back working memory task compared to their performance while they took the placebo. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||Milliseconds||Standard Error|Mean
79824|NCT01001520|Secondary|Cognitive Performance: Accuracy|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.~Specifically, we tested whether subjects, while taking tolcapone, would display increased accuracy during the N-back working memory task compared to their performance while they took the placebo. We measured accuracy by counting the absolute number of true positives scored (the number each subject got correct during the task). This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||Number of true positives||Standard Error|Mean
79825|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Right Dorsolateral Prefrontal Cortex; Right DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.||BOLD signal||Standard Error|Mean
79826|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment|Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Percentage of participants|||Number
79827|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment|Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.||Percentage of participants|||Number
79832|NCT01001390|Secondary|Number of Participants With Improvement in Gait Efficiency While Using an AFO|The difference of net oxygen consumption between wearing AFO and without wearing AFO (difference = wearing AFO - without wearing AFO) will be compared between the baseline study and one month later by using repeated measures analysis in which the effect of time will be tested controlling for other confounding variables.|One month after baseline evaluation|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.|||||
79833|NCT01001390|Primary|Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.|Net oxygen consumption is calculated by the formula: [net oxygen consumption = walking oxygen consumption - sitting oxygen consumption], then adjusted by total mass in kg, including body mass, the mass of the socks, appropriate shoes, helmet, mouth piece system, and for the with AFO trials, the mass of the brace.|Baseline|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.|||||
79834|NCT01001377|Secondary|Number of Participants With Adverse Events (AEs)|Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.|From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.|Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.||participants|||Number
79835|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Functional Well-being Scale Score|The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from “0” to “4” representing “Not at All” through to “Very Much True”. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.||scores on a scale||95% Confidence Interval|Least Squares Mean
79836|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Physical Well-being Scale Score|"The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from 0 to 4 representing Not at All through to Very Much True. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more)."|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.||scores on a scale||95% Confidence Interval|Least Squares Mean
79837|NCT01001377|Secondary|Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score|The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from “0” to “4” representing “Not at All” through to “Very Much True”. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.||scores on a scale||95% Confidence Interval|Least Squares Mean
79838|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as “Worst imaginable health state” and 100 labeled as “Best imaginable health state.” The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data||scores on a scale||95% Confidence Interval|Least Squares Mean
79839|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score|The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and –0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.||scores on a scale||95% Confidence Interval|Least Squares Mean
79840|NCT01001377|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set||months||95% Confidence Interval|Median
79841|NCT01001377|Secondary|Time to Response|Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response||months||Inter-Quartile Range|Median
79842|NCT01001377|Secondary|Duration of Response|Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response||months||95% Confidence Interval|Median
79843|NCT01001377|Secondary|Objective Response|Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1.||percentage of participants||95% Confidence Interval|Number
79844|NCT01001377|Secondary|Progression-free Survival|"Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.~Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions."|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set||months||95% Confidence Interval|Median
79845|NCT01001377|Primary|Overall Survival|Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.||months||95% Confidence Interval|Median
79846|NCT01001325|Primary|Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab|Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)|day +7 post seasonal influenza vaccination (or placebo) to end of study|||participants||95% Confidence Interval|Number
79847|NCT01001299|Secondary|Progression-Free Survival (PFS)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in participants without disease progression were to be considered to be a PFS event on the date of death. Participants who neither progressed nor died were to be censored on the date of the last evaluable tumor assessment prior to the data cutoff date. PD, as assessed by investigator, was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
79848|NCT01001299|Secondary|Time to Response|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed CR or PR (as assessed by investigator), whichever occurred first. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
79849|NCT01001299|Secondary|Duration of Response|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those participants whose best overall response was CR or PR, as assessed by investigator. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).|||||
79850|NCT01001299|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than [<] 10 millimeter [mm]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|Efficacy population included all enrolled participants who received any vemurafenib and had at least one post-baseline tumor assessment.||percentage of participants|||Number
79851|NCT01001299|Primary|CL/F of Probe Parent Drugs on Day 20|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||mL/h||Standard Deviation|Mean
79852|NCT01001299|Primary|Apparent Plasma Clearance (CL/F) of Probe Parent Drugs on Day 1|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||milliliters per hour (mL/h)||Standard Deviation|Mean
79853|NCT01001299|Primary|t1/2 of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.||hours||Standard Deviation|Mean
79854|NCT01001299|Primary|Apparent Elimination Half-Life in Plasma (t1/2) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.||hours||Standard Deviation|Mean
79855|NCT01001299|Primary|Trough Plasma Concentration (Cmin) of Vemurafenib||Before morning dose (0 hour) on Day 19|Primary PK analysis population. Here, number of participants analyzed signifies participants with evaluable data for this outcome.||mcg/mL||Standard Deviation|Mean
79856|NCT01001299|Primary|Tmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.||hours||Full Range|Median
79857|NCT01001299|Primary|Tmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||hours||Full Range|Median
79858|NCT01001299|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||hours||Full Range|Median
79859|NCT01001299|Primary|Cmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
79860|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ng/mL||Standard Deviation|Mean
79861|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
79900|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours (hr)||Full Range|Median
79862|NCT01001299|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8, 12, and 24 Hours (AUC[0-8], AUC[0-12], AUC[0-24]) of Vemurafenib|Area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to 8, 12, and 24 hours (AUC[0-8], AUC[0-12], AUC[0-24], respectively).|0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
79863|NCT01001299|Primary|AUC(0-last) and AUC(0-inf) of Probe Parent Drugs and Their Metabolites on Day 20|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ng*hr/mL||Standard Deviation|Mean
79864|NCT01001299|Primary|AUC(0-last) and Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Probe Parent Drugs and Their Metabolites on Day 1|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||nanograms*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
79865|NCT01001299|Primary|Geometric Mean Ratio of AUC(0-last) and Cmax of Metabolites of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of AUC(0-last) and Cmax of metabolites of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) and Cmax (Day 20/Day 1) for each of the 4 probe drug metabolites is reported (paraxanthine [caffeine metabolite], dextrorphan [dextromethorphan metabolite], OH-midazolam [midazolam metabolite], OH-omeprazole (omeprazole metabolite); S-warfarin does not have a metabolite).|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for paraxanthine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120, dextrorphan 0.5, 1.5, 2, 12, 18, 48, OH-midazolam 0.08, 0.25, 0.5, 0.75, 2, 10, OH-omeprazole 0.5, 1.5, 2, 2.5, 12, 18 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ratio||90% Confidence Interval|Geometric Mean
79866|NCT01001299|Primary|Geometric Mean Ratio of Maximum Plasma Concentration (Cmax) of Probe Parent Drugs|To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of Cmax of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of Cmax (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.||ratio||90% Confidence Interval|Geometric Mean
79867|NCT01001299|Primary|Geometric Mean Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Observed Sampling Time (AUC[0-last]) of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90 percent (%) confidence interval (CI) of AUC(0-last) of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary pharmacokinetic (PK) population: all participants who received all planned doses of vemurafenib without dose modification/interruption up to Day 25 and all doses of 5 cocktail probes, without major protocol violation. Number of Participants Analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.||ratio||90% Confidence Interval|Geometric Mean
79868|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
79881|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
79955|NCT01000974|Secondary|Anti-HBs Concentrations and Concentrations ≥10.0 mIU/mL and Concentrations ≥3.3 mIU/mL||Prior to the booster vaccination||12/2014||||
79869|NCT01001234|Secondary|Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
79870|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
79871|NCT01001234|Primary|Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.||participants|||Number
79872|NCT01001221|Primary|Objective Response Rate With MTD|"Objective response was defined as a confirmed complete response (CR) or a confirmed partial response (PR) during the treatment period, based on RECIST 1.1, as assessed by the Investigator.~CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm.~PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.~The objective response rate (ORR) was to be calculated as the proportion of participants with confirmed objective response relative to the total number of participants in the analysis population. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months||||||
79873|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1: Ratio Day 1/Day 8 for AUClast and AUC|Ratio Day 1/Day 8 for AUClast and AUC were calculated to assess the effect of cabazitaxel on gemcitabine exposure.|Day 1 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion) and Day 8 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion)|Enrolled participants who received at least 1 part of a dose of study treatment and had valid Day 1 and Day 8 PK samples. Valid PK samples included at least 1 post treatment analyzable PK sample and no prohibited concomitant medications.||ratio||Full Range|Mean
79874|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
79875|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Standard Deviation|Mean
79876|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
79877|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Full Range|Median
79878|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample and with no prohibited concomitant medications.||ng/ml||Standard Deviation|Mean
79879|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||ng*hr/ml||Standard Deviation|Mean
79880|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours||Standard Deviation|Mean
79883|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng/ml||Standard Deviation|Mean
79884|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L/m^2||Standard Deviation|Mean
79885|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L/hr/m^2||Standard Deviation|Mean
79886|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L||Standard Deviation|Mean
79887|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||L/hr||Standard Deviation|Mean
79888|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||ng*hr/ml||Standard Deviation|Mean
79889|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.||hours (hr)||Standard Deviation|Mean
79890|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
79891|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||hours (hr)||Full Range|Median
79892|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 8 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of infusion;~Gemcitabine + cabazitaxel: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng/ml||Standard Deviation|Mean
79893|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L/m^2||Standard Deviation|Mean
79894|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L/hr/m^2||Standard Deviation|Mean
79895|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L||Standard Deviation|Mean
79896|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||L/hr||Standard Deviation|Mean
79897|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||hours||Standard Deviation|Mean
79898|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.||ng*hr/ml||Standard Deviation|Mean
79899|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
79901|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 1 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of cabazitaxel infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of gemcitabine infusion;~Gemcitabine + cabazitaxel: prior the start of gemcitabine infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of cabazitaxel infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined.||ng/ml||Standard Deviation|Mean
79902|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assays could not be used for Vss/BSA.||L/m^2||Standard Deviation|Mean
79903|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL/BSA.||L/hr/m^2||Standard Deviation|Mean
79904|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State (Vss)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assay could not be used for Vss.||L||Standard Deviation|Mean
79905|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL.||L/hr||Standard Deviation|Mean
79906|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined||hours (hr)||Standard Deviation|Mean
79907|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC)|Area under the plasma concentration versus time curve extrapolated to infinity|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for AUC.||ng*hr/ml||Standard Deviation|Mean
79908|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)|Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 0 to the last measurable concentration at time t.|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined||ng*hr/ml||Standard Deviation|Mean
79909|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined||hours (hr)||Full Range|Median
79910|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for cabazitaxel assay were collected during cycle 1 and cabazitaxel plasma concentrations were determined using a validated liquid chromatography with tandem mass spectometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1 ng/mL.~Pharmacokinetic (PK) parameters were calculated from plasma concentrations using non-compartmental analysis."|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population: All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample, and with no prohibited concomitant medications||ng/ml||Standard Deviation|Mean
79911|NCT01001221|Post-Hoc|Participant Best Response as Per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|"Participant Best response was assessed by investigator using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1:~Complete response (CR): Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm:~Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion;~Progressive disease (PD): >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions;~Stable disease (SD): not a CR, PR or PD."|Up to a maximum of 22 cycles (median 4 cycles)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment.||participants|||Number
79912|NCT01001221|Secondary|Participants With Adverse Events|"Summary of participants with adverse events (AEs) according to severity and relationship to study drug as assessed by the investigator. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used to grade the severity of AE.~Treatment-emergent adverse events (TEAEs) are AEs that occurred or worsened from start of treatment up to 30 days after treatment ceased.~NCI CTCAE v.3.0 grade 3 =severe and grade 4= life-threatening or disabling."|from first dose of study medication up to 30 days after the last dose of study medication (maximum follow-up of 68 weeks)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment||participants|||Number
79956|NCT01000974|Secondary|Anti-PRP Geometric Mean Concentrations (GMCs)||Prior to the booster vaccination and 1 month after the booster vaccination||12/2014||||
88108|NCT00928083|Secondary|OZ439 AUC0-∝|Area under the plasma concentration-time curve from zero to infinity (AUC0-∝).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
79913|NCT01001221|Secondary|Duration of Response With MTD|"Duration of Response (DR) was defined as the time from the first documentation of RECIST-defined objective tumor response to the first documentation of RECIST-defined objective tumor progression or death.~Median DR was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months||||||
79914|NCT01001221|Secondary|Time To Progression With MTD|"Time to progression (TTP) was defined as the time from first treatment administration to first documentation of RECIST-defined objective tumor progression (>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions).~Median TTP was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months||||||
79915|NCT01001221|Primary|Participants With Dose Limiting Toxicities During Dose Escalation|Dose Limiting Toxicities (DLTs) were defined as clinical adverse events (AE) or laboratory abnormalities considered drug-related as assessed by the Investigator or Sponsor, and achieving a Common Terminology Criteria for Adverse Events v3.0 (CTCAE) severity rating of severe (3) or life-threatening (4).|Day 1 to Day 21 of the first treatment cycle|"DLT population: All participants who completed assessments for DLT evaluation for Cycle 1 and either:~received study treatment during Cycle 1 and had DLT or~did not have DLT and received a full dose of study treatment (no delay/reduction) during Cycle 1 and did not receive hematopoietic growth factors."||participants|||Number
79916|NCT01001208|Secondary|Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 24 score; a positive change from Baseline therefore indicates improvement.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of BSA||Standard Deviation|Mean
79917|NCT01001208|Secondary|Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 12 score; a positive change from Baseline therefore indicates improvement.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of BSA||Standard Deviation|Mean
79918|NCT01001208|Secondary|PASI 90 Response at Week 24|Percentage of participants achieving at least a 90% decrese (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
79919|NCT01001208|Secondary|PASI 90 Response at Week 12|Percentage of participants achieving at least a 90% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
79920|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 12|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 12. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
79921|NCT01001208|Secondary|PASI 75 Response at Week 12|Percentage of participants achieving at least a 75% decrease (i.e. improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used||Percentage of participants|||Number
79922|NCT01001208|Secondary|PASI 50 Response at Week 12|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
79923|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 24|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 24. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
80024|NCT01000324|Secondary|Number of Subjects With Immune Response to the Challenge Vaccine Antigen|None of the subjects received a challenge dose at Years 16, 17, 18 and 20 while, one subject received the challenge dose at Year 19.|Before, 14 days and one month after the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||Subjects|||Number
79924|NCT01001208|Secondary|PASI 50 Response at Week 24|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
79925|NCT01001208|Primary|PASI 75 Response at Week 24|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.||Percentage of participants|||Number
79926|NCT01001195|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 29 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
79927|NCT01001104|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period|Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L).|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage of participants|||Number
79928|NCT01001104|Secondary|Steady-State Concentrations of LY2189265|Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®.|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
79929|NCT01001104|Secondary|Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks|HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage beta-cell function||95% Confidence Interval|Least Squares Mean
79930|NCT01001104|Secondary|Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks|HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage insulin sensitivity (%S)||95% Confidence Interval|Least Squares Mean
79931|NCT01001104|Secondary|Change From Baseline in Total Body Weight at 12 Weeks|Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
79932|NCT01001104|Secondary|Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
79933|NCT01001104|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks|Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
79934|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks|Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).||percentage of participants|||Number
79935|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks|Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).||percentage of participants|||Number
79936|NCT01001104|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.||percentage glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
79937|NCT01001078|Secondary|Airway Manipulation and Blood on Device at Removal||During and after anesthesia when the device is removed.|||participants|||Number
79938|NCT01001078|Secondary|Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)|Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.|On the day following surgery|"5 participants were lost to follow-up and 4 participants had the crossover device or were intubated in the I-Gel group.~4 participants were lost to follow-up and 3 participants had the crossover device or were intubated in the LMA Supreme group (one of participants was lost to follow-up and had the crossover device or was intubated)"||participants|||Number
79939|NCT01001078|Secondary|Number of Participants With Successful Attempts to Introduce the Devices||At the beginning of anesthesia before the beginning of the surgery.|||participants|||Number
79940|NCT01001078|Secondary|Time Needed to Secure the Airway||From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.|||seconds||Standard Deviation|Mean
79941|NCT01001078|Secondary|Measure of the Peak Airway Pressure||After introduction of the SAD before the beginning of the surgery.|||cm H20||Standard Deviation|Mean
79942|NCT01001078|Primary|Measure of the Airway Leak Pressure||After introduction of the supraglottic device before the beginning of the surgery.|||cmH2O||Standard Deviation|Mean
79943|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colcrys™|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose|||ng*hr/mL||Standard Deviation|Mean
79944|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Colcrys™|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose|||ng*hr/mL||Standard Deviation|Mean
79945|NCT01001052|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
79946|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.||Subjects|||Number
79947|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0 to Day 30) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.||Subjects|||Number
79948|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.||Subjects|||Number
79949|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL||At 1 month after booster vaccination||12/2014||||
79950|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C).|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.||Subjects|||Number
79951|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.||Subjects|||Number
79952|NCT01000974|Secondary|Anti-PT, Anti-FHA and Anti-PRN GMCs and Concentrations ≥ 5 EL.U/mL||Prior to the booster vaccination and 1 month after the booster vaccination||12/2014||||
79953|NCT01000974|Secondary|Anti-D and Anti-T Antibody Concentrations and Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL||Prior to the booster vaccination and 1 month after the booster vaccination||12/2014||||
79954|NCT01000974|Secondary|Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8||Prior to the booster vaccination||12/2014||||
79957|NCT01000974|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values|The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79958|NCT01000974|Secondary|Antibody Titers for Poliovirus Types 1, 2 and 3|Antibody titers were given as geometric mean titers(GMTs).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
79959|NCT01000974|Secondary|Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL||At 1 month after the last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP)cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79960|NCT01000974|Secondary|Anti-Hepatitis B (Anti-HBs) Antibody Concentrations|Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||mIU/mL||95% Confidence Interval|Geometric Mean
79961|NCT01000974|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL||Prior to the booster vaccination and 1 month after the booster vaccination||12/2014||||
79962|NCT01000974|Secondary|Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL||At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79963|NCT01000974|Secondary|Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA|Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79964|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.||Subjects|||Number
79965|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 until 6 months following the last primary dose|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.||Subjects|||Number
79966|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) follow-up period after primary vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.||Subjects|||Number
79967|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and symptom sheets completed.||Subjects|||Number
79968|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and with symptom sheets completed.||Subjects|||Number
79969|NCT01000974|Secondary|Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||IU/mL||95% Confidence Interval|Geometric Mean
80520|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
79970|NCT01000974|Primary|Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value|The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79971|NCT01000974|Primary|Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)|Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79972|NCT01000974|Primary|Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations|Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
79973|NCT01000974|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||EL.U/mL||95% Confidence Interval|Geometric Mean
79974|NCT01000974|Primary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
79975|NCT01000974|Primary|Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)||At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79976|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL||At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.||Subjects|||Number
79977|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, AUC(0-t), Between RP103 and Cystagon®.||6 hours post dosing for Cystagon®; 12 hours post dosing for RP103.|||AUC(0-t) (min*mg/L)||Standard Deviation|Least Squares Mean
79978|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Tmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study|||Tmax (minute)||Standard Deviation|Least Squares Mean
79979|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Cmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study|||Cmax (mg/L)||Standard Deviation|Least Squares Mean
79980|NCT01000961|Primary|The Steady-state White Blood Cell Cystine Levels of RP103 Compared to Cystagon®||4 weeks after the last subject has completed the study|||nmol ½ Cystine / mg protein||Standard Error|Least Squares Mean
79981|NCT01000818|Primary|Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir|Area Under the Plasma Concentration-Time Curve and peak concentration|12 hours postdose|Eighteen HIV-Infected Patients||µM*hr||95% Confidence Interval|Geometric Mean
79982|NCT01000805|Secondary|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."||kilograms (kg)||Standard Error|Least Squares Mean
79983|NCT01000805|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."||mm Hg||Standard Error|Least Squares Mean
85127|NCT00953615|Secondary|Soluble Tumor Necrosis Factor - Alpha|Assessment of effect from thalidomide on soluble tumor necrosis factor – alpha compared to baseline values were to be performed at study conclusion.|6 months, baseline|||pg/ml||Standard Deviation|Mean
79984|NCT01000805|Secondary|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, LOCF."||beats per minute (bpm)||Standard Error|Least Squares Mean
79985|NCT01000805|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-blind Treatment Phase – High Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT)|Laboratory assessment of ALT/SGPT during the double-blind treatment phase. Normal ALT/SGPT ranges for males are 6.00 units per liter (U/L) (low) to 43.00 U/L (high). Normal ALT/SGPT ranges for females are 6.00 U/L (low) to 34.00 U/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.||participants|||Number
79986|NCT01000805|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with at least 1 post-baseline C-SSRS result.||participants|||Number
79987|NCT01000805|Secondary|Patient's Global Impressions of Improvement Scale (PGI-I) at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
79988|NCT01000805|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
79989|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
79990|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
79991|NCT01000805|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing consecutive visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.||percentage of participants|||Number
79992|NCT01000805|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a post-baseline result, Last Observation Carried Forward (LOCF).||percentage of participants|||Number
79993|NCT01000805|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
80521|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
79994|NCT01000805|Primary|Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
79995|NCT01000805|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
79996|NCT01000662|Secondary|Late Radiation Toxicities Recorded According to LENT/SOMA||yearly for five years after completion of treatment||||||
79997|NCT01000662|Secondary|QOL (Quality of Life) Questionnaire of Patients on the 2 Different Arms of Treatment||at baseline, at the end of last week of treatment, and at 2 year Follow-up||||||
79998|NCT01000662|Primary|Acute Radiation Toxicities Recorded According to RTOG|Proportion of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost|Day 1 of radiation treatment to day 60|Patients receiving either daily or weekly boost to radiation therapy||participants|||Number
79999|NCT01000610|Secondary|Change in Bone Density (in Participants Untreated With Bisphosphonates)|Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.|Screening and Week 84|ITT population; only participants with an assessment at both screening and Week 84 were included in the analysis.||t-score|||Number
80000|NCT01000610|Secondary|Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.||percentage of participants|||Number
80001|NCT01000610|Secondary|Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.||percentage change from baseline||Standard Deviation|Mean
80002|NCT01000610|Primary|Number of Participants Reporting Adverse Events (AEs)||Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks|Safety Population: Included all participants who have received any part of an infusion of study medication.||number of participants|||Number
80003|NCT01000506|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period|The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.||Scores on a scale||Standard Error|Least Squares Mean
80025|NCT01000324|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity.They were included in the ATP analysis for the primary study, did not receive hepatitis A or B vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
80175|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Quality of Flap Adherence|During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80004|NCT01000506|Secondary|Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.||mL||Standard Error|Least Squares Mean
80005|NCT01000506|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.||Milliliters (mL)||Standard Error|Least Squares Mean
80006|NCT01000506|Secondary|Time to First All Recorded Exacerbation|All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population||Percentage of participants||95% Confidence Interval|Number
80007|NCT01000506|Secondary|Number of All Recorded Exacerbations Per Year|Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population||Exacerbations per year|||Number
80008|NCT01000506|Secondary|Time to First Exacerbation Requiring Hospitalization or ED Visit|Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population||Percentage of participants||95% Confidence Interval|Number
80009|NCT01000506|Secondary|Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year|The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population||Exacerbations per year|||Number
80010|NCT01000506|Secondary|Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population||Percentage of participants||95% Confidence Interval|Number
80011|NCT01000506|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable|From randomization (Week 0) to Week 52 or early withdrawal (EW)|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.||Exacerbations per year|||Number
80012|NCT01000480|Secondary|Number of Participants With an Objective Tumor Response|Participants with confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria, as well as participants with a not evaluable/tumor response unknown. CR: disappearance of all tumor lesions. PR: either a) at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as a reference baseline sum LDs, or b) complete disappearance of target lesions, with persistence (not worsening) of 1 or more nontarget lesions. In either case, no new lesions appeared. SD: small changes that did not meet above criteria. PD: at least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.|Date of first dose through end of follow-up [up to 30 weeks (1 cycle=21 days)]|Intent-to-treat population: Participants who received at least 1 dose of study drug (pemetrexed or cisplatin).||participants|||Number
80013|NCT01000480|Secondary|Overall Survival|Overall survival (OS) was the duration from enrollment to death due to any cause. Participants who were alive were censored at the last contact.|Date of first dose to date of death (up to 35.4 months)|Intent-to-treat population: participants who received at least 1 dose of study drug (pemetrexed or cisplatin). The number of participants censored was 45.||months||95% Confidence Interval|Median
80014|NCT01000480|Primary|1 Year Progression Free Survival|Progression free survival (PFS) was defined as the time from study enrollment to the first observation of progressive disease (PD) or death from any cause. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined PD or death, PFS was censored at the date of the last objective progression-free disease assessment prior to start of postdiscontinuation chemotherapy. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.|Date of first dose to date of objectively determined PD or death [every cycle up to 4 cycles and then every 3 months up to 1 year (1 cycle=21 days)]|Intent-to-treat population: participants who received at least 1 dose of either study drug (pemetrexed or cisplatin). The number of participants censored was 35.||percentage of participants||95% Confidence Interval|Number
80015|NCT01000376|Secondary|Safety of Eribulin Administered Alone or Coadministered With Oral Ketoconazole, as Measured by Number of Subjects With Adverse Events.||monitored throughout||||||
80016|NCT01000376|Primary|Mean (SD) Area Under Concentration Time Curve From Zero to Infinity (AUC 0-oo) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had AUC (0-oo) data.||ng*hr/mL||Standard Deviation|Mean
80017|NCT01000376|Primary|Mean (SD) Maximum Observed Concentration (Cmax) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had Cmax data.||ng*mL||Standard Deviation|Mean
80018|NCT01000337|Secondary|Transaminases||February 2011||||||
80019|NCT01000337|Primary|Changes in the M30 and M65 Markers Related to the Anesthesia Type|Blood samples for determination of the markers M30 and M65 as well as the serum transaminases were collected preoperatively, at the end of surgery, 24 and 48 hours postoperatively.|preoperatively, end of surgery, 24 and 48 hours postoperatively|For an effect size of 0.20 assuming a two-sided error type I error of 0.05 and a power of 0.80, a sample size of 60 sixty patients (30 patients in each group) would be required.||U/L||Standard Deviation|Mean
80020|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event is any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or was a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Up to Year 20.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study.||Subjects|||Number
80021|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||Subjects|||Number
80022|NCT01000324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||Subjects|||Number
80023|NCT01000324|Secondary|Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration|Concentrations are given as Geometric Mean Concentrations (GMCs) expressed as mIU/mL.|At Year 18, 14 days and 30 days post challenge dose (Year 19)|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
80026|NCT01000324|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL).|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity. They were included in the ATP analysis for the primary study, did not receive hepatitis A or B (hep A/B) vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.||Subjects|||Number
80027|NCT01000311|Secondary|Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations|"Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination.~Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine."|From day 1 to 18 months|Analysis was performed on the safety dataset, i.e. all subjects in the exposed population who provided postbaseline safety data||Number of subjects|||Number
80028|NCT01000311|Secondary|Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.|One month after MenACWY-CRM toddler vaccination|Analysis was performed on the PP toddler dataset for MenACWY-CRM.||Percentage of subjects||95% Confidence Interval|Number
80029|NCT01000311|Secondary|Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.||Titers||95% Confidence Interval|Geometric Mean
80030|NCT01000311|Secondary|Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.||Percentage of subjects||95% Confidence Interval|Number
80031|NCT01000311|Secondary|Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.||Percentage of subjects||95% Confidence Interval|Number
80032|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.||μg/mL||95% Confidence Interval|Geometric Mean
80033|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.|One month after third dose of routine infant series vaccination|Analysis was performed on the PP datasets of infants for concomitant, pertussis and hepatitis B vaccinations||μg/mL||95% Confidence Interval|Geometric Mean
80034|NCT01000311|Secondary|Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|"The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.~The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age."|One month after third dose of routine infant series vaccination|Analysis was performed on the PP concomitant, pertussis and hepatitis B infant populations.||Percentage of subjects||95% Confidence Interval|Number
80035|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.||Titers||95% Confidence Interval|Geometric Mean
80036|NCT01000311|Secondary|Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age.~Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM."|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.||Percentage of subjects||95% Confidence Interval|Number
80037|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM vaccination.||Titers||95% Confidence Interval|Geometric Mean
80038|NCT01000311|Primary|Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.~The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A."|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was done on the per-protocol (PP) toddler dataset for MenACWY-CRM, i.e. the subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to database lock.||Percentage of subjects||95% Confidence Interval|Number
80039|NCT01000285|Secondary|Effects of HTLV-1 Integration Sites After Treatment||6 months|||number of integration sites||Standard Error|Mean
80040|NCT01000285|Secondary|Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence||6 months|||percentage of nucleotide divergence||Standard Error|Mean
80041|NCT01000285|Secondary|Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA||6 months|||copies/peripheral blood mononuclear cell||Standard Error|Mean
80042|NCT01000285|Secondary|Relation of NFκB Gene Expression Profile on Response|Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated.|6 months|Average RPKM values normalized to Patient A before therapy.||fold expression||Standard Error|Mean
80043|NCT01000285|Secondary|Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads||6 months|||copies/peripheral blood mononuclear cell||Standard Error|Mean
80044|NCT01000285|Secondary|Time to Progression||Up to 4 years following completion of therapy|12 out of the 18 participants had a complete or partial response.||days||Full Range|Median
80045|NCT01000285|Primary|Efficacy of Treatment as Measured by Best Overall Response|-The response definitions used for this study are the 2007 Cheson criteria.|Up to 4 years following completion of therapy|||participants|||Number
80046|NCT01000285|Primary|Tolerability of Treatment as Measured by Grade and Frequency of Grade 3 or Higher Adverse Events|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|Up to 30 days after completion of treatment|||participants|||Number
80047|NCT01000155|Primary|Percent Fetal Hemoglobin (HbF%) Induction Success Rate|Success will be defined by comparing the maximum HbF% on study drug to the HbF% at baseline. An absolute increase in HbF% of 4% of more, or an increase to 100% or more of baseline in patients with HbF under 4% at baseline will be considered a success. HbF% induction success rate is calculated as the count of successes divided by the count of particpants in the analysis population.|HbF% was measured at baseline and weekly on treatment. Median duration of treatment was 3 months.|The analysis dataset is comprised of all treated patients.||proportion of patients||90% Confidence Interval|Number
80048|NCT01000025|Secondary|Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0|Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0|42 Months|As treated population||participants|||Number
80049|NCT01000025|Secondary|Objective Response Rate|Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.|42 months|ITT||percentage of participants||95% Confidence Interval|Mean
80050|NCT01000025|Secondary|Progression-free Survival|progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee|42 Months|ITT||Months||95% Confidence Interval|Median
80051|NCT01000025|Secondary|Overall Survival in EGFR-mutant Patients|Overall survival by EGFR-mutantion subgroups|42 Months|Patients with EGFR mutation||Months||95% Confidence Interval|Median
80052|NCT01000025|Secondary|Overall Survival in KRAS-WT Patients|Median and 95% confidence intervals of Overall survival in KRAS-WT patients|42 Months|Patients with K-Ras mutation wild type||Months||95% Confidence Interval|Median
80053|NCT01000025|Primary|Overall Survival|Median and 95% confidence intervals|42 Months|ITT||Months||95% Confidence Interval|Median
80174|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Rate of Healing|During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80054|NCT00999921|Secondary|Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)|"All patients who had an increase in breast pain in the perimenstrual period were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia"|3 months|114 patients were identified as having cyclical mastalgia of whom 58 patients(37 fibroadenosis, 3 fibroadenonomas and 18 mastalgias with no lump) received Tamoxifen and 56 (36 fibroadenosis, 3 fibroadenomas and 17 mastalgias with no lump) received Evening Primrose Oil for 3 months. Good response was defined as disappearance of cyclical mastalgia.||participants|||Number
80055|NCT00999921|Primary|Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).|All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response|3 months|88 patients treated with Tamoxifen and 47 patients treated with Evening Primrose Oil were assessed for Cardiff Breast Pain Score. Patients with fibroadenomas and those with Grade 0 pain at the beginning of therapy were excluded from this analysis.||participants|||Number
80056|NCT00999921|Primary|Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)|Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.|3 months|102(out of 127) patients receiving Tamoxifen and 99(out of 129) receiving Evening Primrose Oil were assessed for reduction in lump size. The remaining patients had mastalgia with no lump, hence were excluded from this assessment. A 60% or more reduction in lump size after completion of the therapy was considered as a satisfactory response.||participants|||Number
80057|NCT00999908|Secondary|Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.||Liters||Standard Deviation|Mean
80058|NCT00999908|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.||Liters||Standard Deviation|Mean
80059|NCT00999908|Primary|Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.|4 hour period following inhalation of study treatment|Per protocol population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period and who were compliant with the protocol and without any major deviation likely to affect the analysis of pulmonary function measurements.||Liters||Standard Deviation|Mean
80060|NCT00999830|Secondary|Safety Assessment|Adverse Events, Serious Adverse Events, physical examination and biological changes.|from screening visit to the End of Study (at each study visit)|||participants|||Number
80061|NCT00999830|Secondary|Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment|KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.|From the start up to the end of study (15 months)|||% of occupancy||Full Range|Median
80062|NCT00999830|Primary|Rate of Patients Achieving a Response Based on M-protein or Free Light Chains|"Response was defined:~In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;~In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis~In patients with serum M-protein < 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (<0.26 or > 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels."|From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices|||participants|||Number
80063|NCT00999804|Secondary|Clinical Response||12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participants were not evaluable for efficacy.||participants|||Number
80064|NCT00999804|Secondary|Total Pathologic Complete Response|pathologic complete response was defined as no residual invasive cancer in the breast and the axillary lymph nodes.|12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.||participants|||Number
80065|NCT00999804|Secondary|Number of Participants With Adverse Events|the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy|12 week or 24 weeks depending on arm assignment|Participants who started the study treatment will be evaluable for safety analysis||participants|||Number
80066|NCT00999804|Primary|Pathologic Complete Response|"Pathologic complete response was defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy.~This outcome is based on patient's pathological report. We are not measuring the clinical response.~Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable."|12 or 24 week depending the arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.||participants|||Number
80067|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 24|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.||units on a scale||95% Confidence Interval|Mean
80068|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 12|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.||units on a scale||95% Confidence Interval|Mean
80069|NCT00999661|Secondary|Change in Body Mass Index From Baseline to 24 Months|Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.|Baseline to 24 months|||kilograms per meters squared||Standard Deviation|Mean
80070|NCT00999661|Secondary|% Excess Weight Change From Baseline to 12 Months|Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 12 months|Intent to Treat Population||percent of excess weight at baseline||Standard Deviation|Mean
80071|NCT00999661|Primary|Percent Excess Weight Change From Baseline to 24 Months|Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 24 months|Intent to Treat Population - All subjects implanted with gastric band and signing informed consent.||percent of excess weight at baseline||Standard Deviation|Mean
80072|NCT00999596|Primary|FFDM (Full Field Digital Mammography) Mammogram Scores|6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.|Day 1|This was not a statistical sample per FDA FFDM Guideline. FDA Guideline specified that a minimum of 6 film sets from the participants be analyzed. The number of participants required by FDA changed mid-study.||FFDM Mammogram set|||Number
80073|NCT00999544|Secondary|Aprepitant Side Effects||42 days||||||
80074|NCT00999544|Primary|Abuse Liability Proxy|"Visual analog scale ratings (from 0-100) on the subject-rated measure of How much do you like the drug? with higher scores indicating greater abuse liability (and 100 anchored with extremely and zero indicating none anchored with none at all. Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure."|42 days|Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges. The within subject data analysis does not lend itself to reporting data in the format provided below.||units on a scale (points 0-100)||Standard Deviation|Mean
80075|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80076|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80077|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80078|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80079|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80080|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80081|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80082|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80083|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80084|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80085|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80086|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80087|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80088|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80089|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80090|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80091|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80092|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80093|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80094|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80095|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80096|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80097|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80098|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80099|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80100|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80101|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80102|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80103|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80104|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||10^6 cells/g||Full Range|Geometric Mean
80105|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
80106|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
80107|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
80108|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
80109|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
80110|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||Cell count/g||Full Range|Geometric Mean
80111|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80112|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80113|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80114|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80115|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80116|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80117|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80118|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
88690|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
80119|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80120|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80121|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80122|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80123|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80124|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80125|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80126|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80127|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80128|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80129|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80130|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80131|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80132|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80176|NCT00999141|Other Pre-specified|Investigator Preference for Side of Face|Investigator reported outcomes data was collected for overall preference for 1 side of face|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80133|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80134|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80135|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80136|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80137|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80138|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80139|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80140|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80141|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80142|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80143|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80144|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80145|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80146|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80222|NCT00998738|Secondary|Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80147|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80148|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80149|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80150|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80151|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80152|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||pg/mL||Full Range|Geometric Mean
80153|NCT00999466|Secondary|PC20 Methacholine Challenge – 4 Weeks After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
80154|NCT00999466|Secondary|PC20 Methacholine Challenge – 4 Weeks After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
80155|NCT00999466|Secondary|PC20 Methacholine Challenge – 1 Week After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
80156|NCT00999466|Secondary|PC20 Methacholine Challenge – 1 Week After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
80157|NCT00999466|Secondary|PC20 Methacholine Challenge – Pre-treatment, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
80158|NCT00999466|Secondary|PC20 Methacholine Challenge – Pre-treatment, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||mg/mL||Full Range|Geometric Mean
80159|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – 4 Weeks After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
80241|NCT00998335|Secondary|Advanced Lipid Testing|Change in lipoprotein particle number was determined using NMR.|3 and 6 months|||Change in number of particles (nmol/L)||Standard Deviation|Mean
80160|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – 1 Week After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
80161|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – Pre-treatment|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
80162|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – 4 Weeks After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
80163|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – 1 Week After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
80164|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – Pre-treatment|Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.||ratio||Standard Deviation|Mean
80165|NCT00999167|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score|Changes from Baseline to Day 56 and the Final Visit were compared between treatment groups using an ANCOVA model for the total index RBANS score ). The index score is a sum of the scores for each of the 5 individual domains (immediate memory, visuospatial/constructional, language, attention). The minimum and maximum total index scores are 40 and 160, respectively; a higher score is better.|Day 56, Final Visit (D112)|Intent to treat (ITT)||units on a scale||Standard Error|Least Squares Mean
80166|NCT00999167|Secondary|Time to Meeting the Primary Endpoint|Secondary efficacy endpoint. The time to the first HE episode during the treatment period was calculated using the Kaplan-Meier method. Subjects who did not experience an HE episode were censored at the time of their last asterixis assessment. Subjects who had no post-randomization data for the primary endpoint were considered to have an HE episode at Day 1.|112 Days|Intent to treat (ITT)||Days||95% Confidence Interval|Median
80167|NCT00999167|Primary|Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0|"An HE event was defined as occurrences of either a West Haven (WH) Grade ≥2 or a WH Grade 1 and asterixis grade increase of 1 (if baseline WH = 0).~The WH criteria are widely used for rating the severity of HE and are summarized below:~Grade 1: trivial lack of awareness, euphoria or anxiety, shortened attention span, impaired performance of addition Grade 2: lethargy or apathy, minimal disorientation for time or place, subtle personality change, inappropriate behavior, impaired performance of subtraction Grade 3: somnolence to semi-stupor but responsive to verbal stimuli, confusion, gross disorientation Grade 4: coma (unresponsive to verbal or noxious stimuli)~Asterixis was assessed after arm and forearm extension along with wrist dorsiflexion for 30 seconds and assigned a grade according to the following criteria:~Grade 1: rare flaps Grade 2: occasional irregular flaps Grade 3: frequent flaps Grade 4: continuous flaps"|Part B: 112 Days|Intent to Treat (ITT)||participants|||Number
80168|NCT00999167|Secondary|Total Number of HE Events|Secondary efficacy endpoint. The total number of HE events during the treatment phase for subjects in the placebo and active arms.|112 Days|Intent to treat (ITT)||HE event|||Number
80169|NCT00999167|Primary|Part A: The Rate of AEs and Tolerability of HPN-100|Part A: The rate of AEs and tolerability of 6 mL and 9 mL doses of HPN-100 were considered the primary safety endpoints for Part A. Safety assessments included adverse events, laboratory tests (including ammonia, hematology, coagulation, liver function and serum chemistry parameters), vital signs, physical and neurological examinations, and electrocardiograms.|Part A: 28 days|Safety population||Subjects|||Number
80170|NCT00999141|Primary|Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)||Day 0 (day of surgery) through postoperative Day 14|Safety Analysis Set||Events|||Number
80171|NCT00999141|Other Pre-specified|Total Aspiration Volumes From Hematomas and Seromas||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||mL||Full Range|Median
80172|NCT00999141|Other Pre-specified|Investigators’ Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80173|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Treatment|During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80177|NCT00999141|Other Pre-specified|Participants' Assessment of Difference in Numbness Between Two Sides of Face|"During each postoperative visit (Day 1, 3, 7, and 14), participants were asked:~How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible?~Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score)~The planned and approved Statistical Analysis Plan (SAP) called for a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Scores on a scale||Standard Deviation|Mean
80178|NCT00999141|Secondary|Reasons for Participants’ Preferences for Side of Face|"Participants responded to the following questions during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?~If right or left is chosen, participants were asked Please mark ALL reasons for choosing this side~Better skin sensation~Less numbness~Looks better~Less bruising~Less swelling~Less pain~Less itching~Less tingling~Less feeling of pins and needles~Other ________________ (Free Text)"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Participants|||Number
80179|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
80180|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
80181|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
80182|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants||Proportion of Participants|||Number
80183|NCT00999141|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80184|NCT00999141|Secondary|Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14|Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0).|Day 0 (preoperative) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||Handle number(s)||95% Confidence Interval|Mean
80185|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80186|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80187|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80188|NCT00999141|Secondary|Investigators’ Visual Comparisons of Edema Between the 2 Sides of Face at Day 1|Investigators’ assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80189|NCT00999141|Secondary|Number of Participants With Hematoma/Seroma Anytime During the Study||Day 0 (day of surgery) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80190|NCT00999141|Secondary|Participants With Hematoma/Seroma by Study Day|Investigators assessed each side of the face for the presence of hematoma and/or seroma|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80191|NCT00999141|Secondary|Participants' First Occurrence of Hematoma or Seroma by Study Day|Investigators assessed each side of the face for the presence of hematomas and/or seromas|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants||participants|||Number
80192|NCT00999141|Primary|Total Volume of Drainage on Each Side of the Face|Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).|24 hours (± 4h) after surgery|Full Analysis Data Set = All randomized and treated participants||mL||Full Range|Median
80242|NCT00998335|Secondary|Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||mg/dL||Standard Deviation|Mean
80193|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT3 participant treated with 800 mg grazoprevir, who discontinued, and all GT1 participants were excluded from analysis.||log10 IU/mL||95% Confidence Interval|Least Squares Mean
80194|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT1 participant treated with 50 mg grazoprevir, who discontinued, and all GT3 participants treated with grazoprevir were excluded from analysis.||log10 IU/mL||95% Confidence Interval|Least Squares Mean
80195|NCT00998985|Secondary|24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.|Day 7 at 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.||nM||90% Confidence Interval|Geometric Mean
80196|NCT00998985|Secondary|Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.|Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.||uM.hr||90% Confidence Interval|Geometric Mean
80197|NCT00998985|Primary|Number of Participants With Clinical and Laboratory Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)|All participants who received at least one dose of the investigational drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment were combined for the summary into a single GT1 and GT3 arm.||Participants|||Number
80198|NCT00998881|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
80199|NCT00998881|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*h / dL||Standard Error|Least Squares Mean
80200|NCT00998881|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
80201|NCT00998881|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||Percent||Standard Error|Least Squares Mean
80202|NCT00998868|Secondary|Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System|"Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group.~MRC scale:~Grade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement."|within one month after enrollment|||Units on a scale (minimum 0, maximum 5)||Standard Deviation|Mean
80522|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80203|NCT00998868|Secondary|Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination|The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.|within one month after enrollment|||participants|||Number
80204|NCT00998868|Secondary|Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography|All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment|||participants|||Number
80205|NCT00998868|Primary|Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography|All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment|||participants|||Number
80206|NCT00998764|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80207|NCT00998764|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80208|NCT00998764|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80209|NCT00998764|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80210|NCT00998764|Secondary|Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on scale||Standard Error|Least Squares Mean
80243|NCT00998335|Secondary|Metabolic Control as Measured by the Fasting Plasma Glucose Concentration||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||mg/dL||Standard Deviation|Mean
85128|NCT00953615|Secondary|Mayo Risk Score|The Mayo Risk Score estimates the survival probability of a patient with primary sclerosing cholangitis based on the following variables: age, bilirubin, albumin, AST and history of variceal bleeding.|6 months|||units on a scale|||Number
80211|NCT00998764|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80212|NCT00998764|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8)remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80213|NCT00998764|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8 remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80214|NCT00998764|Primary|Number of Participants Reporting a Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|Safety population||Number of Participants|||Number
80215|NCT00998738|Secondary|Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy|Correlation coefficients will be produced relating the worst pain scores in the first cycle of therapy and the subsequent neuropathy scores as judged from the daily and weekly questions.|First cycle of therapy (up to 21 days)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80216|NCT00998738|Secondary|Severity of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.~The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80217|NCT00998738|Secondary|Incidence of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.~The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80218|NCT00998738|Secondary|Toxicity Profile of CaMg Per CTCAE Active Version||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80219|NCT00998738|Secondary|Average Cumulative Ixabepilone Dose||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80220|NCT00998738|Secondary|Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80221|NCT00998738|Secondary|Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version|Time to onset of grade 2+ neurotoxicity was defined as time from randomization to the first occurrence of grade 2+ neurotoxicity. Time to onset of grade 3+ neurotoxicity was defined as time from randomization to the first occurrence of grade 3+ neurotoxicity.|Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80223|NCT00998738|Primary|Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.|During the first 18 weeks of ixabepilone-based therapy|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.|||||
80224|NCT00998660|Primary|Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.|Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.|3 months|The 93 implanted subjects accumulated 283.6 subject-months of follow-up through the 3-month visit. There were no reported user-related battery depletion adverse events that required an intervention by a health care professional and/or HCP designee.||Event rate per 100 subject-months||95% Confidence Interval|Number
80225|NCT00998582|Primary|Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease.|Change from baseline to 24 weeks|Large artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in large artery elasticity (mL/mmHg x10) from baseline to week 24||ml/mmHg x10||Inter-Quartile Range|Median
80226|NCT00998582|Primary|Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|Change from baseline to 24 weeks|Small artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in small artery elasticity (mL/mmHg x100) from baseline to week 24||ml/mmHg x100||Inter-Quartile Range|Median
80227|NCT00998517|Secondary|Rates of Gain in Mid-upper Arm Circumference, and Length|These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks|||mm/d||Standard Deviation|Mean
80228|NCT00998517|Secondary|Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)|Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.|12 months|Children who successfully recovered from MAM following the standard treat-to-WHZ -2 protocol.||participants|||Number
80229|NCT00998517|Secondary|Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment||2 weeks|||participants|||Number
80230|NCT00998517|Secondary|Number of Patients With Adverse Outcomes|This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.|12 months|||participants|||Number
80231|NCT00998517|Secondary|Rate of Weight Gain|This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks|||g/kg/d||Standard Deviation|Mean
80232|NCT00998517|Primary|Number of Patients With Absence of Bilateral Pedal Pitting Edema||12 weeks or recovery|||participants|||Number
80233|NCT00998517|Primary|Number of Participants With Nutritional Recovery|"Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.~WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/"|12 weeks or upon completion of recovery|||participants|||Number
80234|NCT00998426|Primary|Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection|All participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).|Pre-dose, immediately following, 60 min and 120 min after injection|||mg/dL||Standard Deviation|Mean
80235|NCT00998374|Primary|Reactive Hypoglycemia Status|"Postoperative reactive hypoglycemia was defined as either~serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing~serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing"|6 months, 9 months, 12 months post-op|||participants|||Number
80236|NCT00998374|Secondary|Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing|Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients’ responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response|6, 9, and 12 months post-op|||participants|||Number
80237|NCT00998374|Secondary|Insulin Resistance|Measured by levels of post prandial insulin|6, 9, and 12 months post-operatively|||pmol/L||Standard Deviation|Mean
80238|NCT00998374|Primary|Mean Serum Glucose Levels|Serum glucose levels measured to assess reactive hypoglycemia status|30, 60, and 120 minutes at 6, 9, and 12 months post-operatively|||mg/dl||Standard Deviation|Mean
80239|NCT00998335|Secondary|Percent Change From Baseline in Vascular Inflammatory Markers|Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM|3 and 6 months|||Percentage of change||Standard Deviation|Mean
80240|NCT00998335|Secondary|Change in Anthropometric Measure (Body Mass Index [BMI]).|Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||Change from baseline (Kg/m2)||Standard Deviation|Mean
80244|NCT00998335|Secondary|Number of Hypoglycemic Events|Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial.|3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||Number of events|||Number
80245|NCT00998335|Secondary|Change in Anthropometric Measure (Body Weight).|Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||Change from baseline (Kg)||Standard Deviation|Mean
80246|NCT00998335|Secondary|Plasma Lipid Concentration.|Fasting plasma lipid concentration on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||mg/dL||Standard Deviation|Mean
80247|NCT00998335|Secondary|Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).|Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"||% of intramyocellular triglyceride||Standard Deviation|Mean
80248|NCT00998335|Secondary|Change in Insulin Secretion|Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 at 3 months and N=28 at 6 months."||ng/ml||Standard Deviation|Mean
80249|NCT00998335|Secondary|Metabolic Control as Measured by the A1c||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms."||percentage of A1c||Standard Deviation|Mean
80250|NCT00998335|Primary|Hepatic Steatosis|Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).|3 and 6 months|In six patients liver MRS was not possible due to claustrophobia, metal parts, or too large for MRI scanner. N=30 participants in the Insulin detemir x 3 months, N=8 participants in the Insulin Detemir alone and 22 in the Detemir Plus Aspart at 6 months.||percentage of liver fat||Standard Deviation|Mean
80251|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80252|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80253|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80254|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80255|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80256|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80257|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80258|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80259|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80260|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection|"Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80261|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80262|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80263|NCT00998309|Primary|Number of Unlisted Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||Events|||Number
80264|NCT00998309|Primary|Number of Participants With Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.||participants|||Number
80265|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy|Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80266|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)|Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80267|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)|Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80268|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications|Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80269|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)|Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80270|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)|Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80271|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)|Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80272|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity|"Number of participants with responders of azithromycin to determine whether Infection severity, mild infection, moderate infection, or severe infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80273|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection|"Number of participants with responders of azithromycin to determine whether type of infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80274|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age|Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80275|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender|Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80276|NCT00998309|Primary|Number of Participants With an Investigator’s Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.|The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
80277|NCT00998296|Secondary|Percentage Change in the Tumour Size From Baseline During the Expansion Phase|Percentage change in the tumour size from baseline is expressed as Number of subjects with maximum decrease from baseline in the sum of longest diameters of target lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||participants|||Number
80278|NCT00998296|Secondary|Stable Disease for at Least 12 Weeks During the Expansion Phase|"SD: Neither sufficient shrinkage to qualify for PR (Partial response) nor sufficient increase to qualify for PD(Progressive disease), taking as references the smallest sum of diameters SoD while on study.~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||percentage of participants|||Number
80279|NCT00998296|Secondary|Disease Control (DC) During the Expansion Phase|DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD. CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:- CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; SD for TL: change in the sum of diameters does not satisfy PR or PD. SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||percentage of participants|||Number
80280|NCT00998296|Secondary|Objective Response (OR) During the Expansion Phase|"OR is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions.~CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be nonpathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:~CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set||percentage of participants|||Number
80281|NCT00998296|Secondary|Trough Plasma Concentration of Afatinib at Steady State|"C(pre,ss) is defined as pre-dose (trough) concentration of afatinib in plasma at steady state immediately before administration of the next dose.~C24,7 corresponds to the plasma concentration at 24 hours on Day 7. C24,13 corresponds to the plasma concentration at 24 hours on Day 13. C24,27 corresponds to the plasma concentration at 24 hours on Day 27."|Day 7, Day 13, Day 15, Day 22, Day 27 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
80282|NCT00998296|Secondary|Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)|"Cpre,ss,norm (Dose normalized trough plasma concentration of nintedanib at steady state) are presented for the 2 MTD treatment groups (continuous administered nintedanib at 150 mg b.i.d. concomitantly with continuously administered afatinib 30 mg q.d. or with intermittently administered afatinib 40 mg q.d.)~As nintedanib is given twice daily, samples are taken at Day 8, Day 15, Day 22 and Day 28; the Pharmacokinetic (PK) parameter names will be Cpre,ss,15,norm (Day 8), Cpre,ss,29,norm (Day 15), Cpre,ss,43,norm (Day 22) and Cpre,ss,55,norm (Day 28)"|Day 8, Day 15, Day 22 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"||nanogram/millilitre/milligram (ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
80284|NCT00998296|Secondary|Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First treatment administration until cut-off date of 02Oct2014; up to 336 days|TS||participants|||Number
80285|NCT00998296|Secondary|Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|"The investigator evaluated whether complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) occurred in a patient.~CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions"|6 weeks|TS||percentage of participants|||Number
80286|NCT00998296|Primary|Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities|Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.|first treatment cycle, up to 28 days|TS||percentage of participants|||Number
80287|NCT00998049|Secondary|Rate of Failure to Mobilize|The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.|Duration of apheresis (up to 7 days)|||percentage of participants||95% Confidence Interval|Number
80288|NCT00998049|Secondary|Time to Reach 6 Million CD34 Cells|Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.|Duration of apheresis (up to 7 days)|||days||95% Confidence Interval|Median
80289|NCT00998049|Secondary|Median Number of Days of Apheresis||Duration of apheresis (up to 7 days)|||days||Full Range|Median
80290|NCT00998049|Secondary|CD34 Yield Day 2|Number of CD34 cells/kg collected on day 2|Day 2|||cells/kg||Full Range|Median
80291|NCT00998049|Secondary|CD34 Yield on Day 1|Number of CD34 cells/kg collected on day 1.|Day 1|||cells/kg||Full Range|Median
80292|NCT00998049|Primary|Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis|"Number of CD34 cells/kg collected on days 1-2.~Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm."|After 2 days of apheresis|||participants|||Number
80293|NCT00998023|Secondary|Major Complications|Number of participants with permanent access site-related nerve injury, access-site related surgical/vascular repair, amputation related to access closure complication, access site-related bleeding/hematoma requiring transfusion, any new ipsilateral lower extremity ischemia requiring non-surgical intervention, local access site-related or generalized infection requiring prolonged hospitalization or re-hospitalization and treatment with IV antibiotics or inflammatory reaction that may include local signs and drainage, treated with re-hospitalization, IV antibiotics and/or surgical intervention|1 Day|Per protocol||Participants|||Number
80294|NCT00998023|Primary|Mean Score on the Visual Analogue Scale|The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).|Immediately before vascular closure and immediately after vascular closure.|Per protocol||Scores on a Scale||Standard Error|Mean
80295|NCT00997984|Secondary|Change From Baseline in Weight at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||pounds||Standard Deviation|Mean
80296|NCT00997984|Secondary|Change From Baseline in Height at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||inches||Standard Deviation|Mean
80297|NCT00997984|Secondary|Change From Baseline in Oral Temperature at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||º F||Standard Deviation|Mean
80298|NCT00997984|Secondary|Change From Baseline in Pulse Rate at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||beats per minute||Standard Deviation|Mean
80299|NCT00997984|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||mmHg||Standard Deviation|Mean
80300|NCT00997984|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population||mmHg||Standard Deviation|Mean
80301|NCT00997984|Secondary|Change From Baseline in Mean Weiss Functional Impairment Rating Scale – Parent Report (WFIRS-P) Global Score at Week 8 - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
80302|NCT00997984|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 8 weeks|FAS||Percent of Participants|||Number
80303|NCT00997984|Secondary|Change From Baseline in the Bedtime Resistance Subscale of Child’s Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF|The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
80304|NCT00997984|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
80305|NCT00997984|Secondary|Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
80306|NCT00997984|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and up to 8 weeks|Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.||Units on a scale||Standard Error|Least Squares Mean
80307|NCT00997984|Secondary|Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS||Percent of Participants|||Number
80308|NCT00997984|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and up to 8 weeks|FAS||Percent of Participants|||Number
80309|NCT00997984|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study.||Units on a scale||Standard Error|Least Squares Mean
80310|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||48 weeks||||||
80311|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||24 weeks||||||
80312|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||48 weeks||||||
80313|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||24 weeks||||||
80314|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||48 weeks||||||
80315|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||48 weeks||||||
80316|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||24 weeks||||||
80317|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||0 weeks||||||
80318|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||0 weeks||||||
80319|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||0 weeks||||||
80320|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||0 weeks||||||
80321|NCT00997672|Primary|Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.|Number of Adverse Events and their relative frequency in treatment groups was analyzed|the endpoint will be recorded at all visits|||number of AEs|||Number
80322|NCT00997594|Primary|Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation|Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.|1 week|||participants|||Number
80323|NCT00997594|Primary|Serum Cathecholamine Levels||around one year||10/2015||||
80324|NCT00997594|Secondary|Increase in Cortisol||1 day||||||
80325|NCT00997594|Primary|Increase in Catecholamine||One day||||||
80326|NCT00997555|Secondary|Length of Hospital Stay|Number of hospital days (bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).|until discharge from hospital, data reviewed every 6 months|||days||95% Confidence Interval|Median
80327|NCT00997555|Secondary|Length of ICU Stay|Number of ICU days (bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).|until discharge from hospital, data reviewed every 6 months|||days||95% Confidence Interval|Median
80328|NCT00997555|Secondary|Length of Mechanical Ventilation|Days of mechanical ventilation (bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|until discharge from hospital, data reviewed every 6 months|||days||95% Confidence Interval|Median
80329|NCT00997555|Secondary|Incidence of Pneumonia|Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)|until discharge from the hospital, data reviewed every 6 months|||participants|||Number
80330|NCT00997555|Primary|Respiratory Associated Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months|||participants|||Number
80331|NCT00997555|Primary|All Cause Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months|||participants|||Number
80348|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80332|NCT00997516|Secondary|Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months.|"The Cosmetic Appearance Scale assessed the degree of satisfaction with the physical appearance of the abdomen (and its scars) using a visual analogue scale. Numeric scores were obtained by measuring the horizontal distance from the low end of the scale to the marking, and then normalized on a scale of 0-20 points. Higher scores indicate a higher degree of satisfaction.~Since your operation, how would you describe the overall appearance of your abdomen? (Revolting; Beautiful) Since your operation, how would you describe your incisional scars? (Revolting; Beautiful) How satisfied are you with your incisional scars? (Very unsatisfied; Very satisfied) How much discomfort do your incisional scars cause? (Severe, daily pain; No pain at all) Can you score your own incisional scar? (Worst possible scar; Best possible scar)"|6 months|Participants who returned surveys for long-term follow-up||units on a scale||Standard Deviation|Mean
80333|NCT00997516|Secondary|Body Image Score at 6 Months|"After a minimum of 6 months, a Body-Image Questionnaire was sent to participants. The questionnaire has 5 questions, with answers ranging from 1 (Extremely) to 4 (Not at all); lower scores indicate worse satisfaction with and perception of bodily appearance.~Are you less satisfied with our body since the operation? Do you think the operation has damaged your body? Do you feel less attractive as a results of your operation? Do you feel less feminine or masculine as a result of your operation? Is it difficult to look at yourself naked?"|6 months|67 of 75 patients completed and returned follow-up surveys||units on a scale||Standard Deviation|Mean
80334|NCT00997516|Secondary|Readmission Within 30 Days.|Number of participants readmitted to the hospital within 30 days of surgery|30 days|||participants|||Number
80335|NCT00997516|Secondary|Time to Return to Work|Number of calendar days between participants' discharge from the hospital and the first day back at work.|30 days|||Days||Standard Deviation|Mean
80336|NCT00997516|Secondary|Wound Seroma|Number of participants who experienced un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery.|6 months|||participants|||Number
80337|NCT00997516|Secondary|Deep Space Infection|Number of participants who required reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses were classified as deep space infections.|6 months|||participants|||Number
80338|NCT00997516|Secondary|Wound Infection|Number of participants who required additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis.|6 months|||participants|||Number
80339|NCT00997516|Secondary|Length of Stay|Number of calendar days the participant was hospitalized.|up to 14 days|||Days||Standard Deviation|Mean
80340|NCT00997516|Secondary|Visceral or Vascular Injury|Number of participants who required intervention (suture or stapled repair, use of hemostatic agents) for injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection.|during surgery, up to 6 hours|||participants|||Number
80341|NCT00997516|Secondary|Procedures Requiring Conversion to Open or Additional Port|Patients requiring use of additional incisions and/or trocars, or the need to perform an open procedure.|during surgery , up to 6 hours|||participants|||Number
80342|NCT00997516|Secondary|Operative Time|The amount of time to perform the operation from skin-incision to application of the dressing. This time is routinely charted by the circulating nurse in the operating room.|up to 6 hours|||minutes||Standard Deviation|Mean
80343|NCT00997516|Primary|Pain After Surgery|Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.|12 hours post-surgery|||units on a scale||Standard Deviation|Mean
80344|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80345|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80346|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium~Binary Rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80347|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80382|NCT00997438|Secondary|RANTES Levels||24 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.||pg/mL||Standard Error|Mean
80349|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80350|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80351|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80352|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80353|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80354|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80355|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80356|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80357|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80358|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80359|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80360|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80361|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80362|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80363|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80364|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80365|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80366|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80367|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80383|NCT00997438|Primary|cAMP Levels||4 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients||pmol cAMP/mg protein||Inter-Quartile Range|Median
80384|NCT00997438|Primary|cAMP Levels||2 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients||pmol cAMP/mg protein||Inter-Quartile Range|Median
80368|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80369|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.~Binary Rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80370|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80371|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80372|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80373|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80374|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80375|NCT00997503|Secondary|Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related|MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80376|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80377|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80378|NCT00997503|Secondary|Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population|Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations|12 months|To be included, subject was a medically treated diabetic at the time of enrollment. Also, subjects met the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. There were 2945 subjects that did not meet the criteria for this analysis.||percentage of participants|||Number
80379|NCT00997503|Secondary|Incremental Rate of Stent Thrombosis (Protocol Definition)|"Stent Thrombosis (protocol definition):~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|1-2 years|To be analyzed in this secondary analysis, a subject needed to have an endpoint event between 1-2 years or sufficient follow-up through 2-years. There were 448 subjects that did not meet the criteria for this analysis.||percentage of participants|||Number
80380|NCT00997503|Primary|Cardiac Death or Myocardial Infarction|Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.||percentage of participants|||Number
80381|NCT00997438|Secondary|RANTES Levels||48 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.||pg/mL||Standard Error|Mean
80391|NCT00997425|Primary|Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)|Door and floor cover interventions were compared for efficacy in reducing wandering behavior defined as patient approaching or passing through the equipped exit door. Counts of each behavior were collected on each patient for each intervention period. Mean values of counts were compared.|eight weeks|per protocol||behavior counts||Standard Error|Mean
80392|NCT00997373|Primary|Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer|Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue|At time of consent and after hysterectomy (generally about 3 weeks)|"Subjects completing treatment who had confirmed histopathology compared to a non-randomized group of untreated control subjects. Aromatase inhibitor responsiveness was defined as a proportionate decline in %Ki67 staining of at least 70% between pre-treatment biopsy and hysterectomy 9or repeat biopsy)."||percentage of Ki67 staining cells||Full Range|Mean
80393|NCT00997321|Secondary|Depth of Sedation|Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain|single measurement during sedation procedure|100 patients were randomized, 50 to the propofol group, 50 of whom underwent sedation, and 50 in the ketamine group, 47 of whom underwent sedation||score on a scale||Full Range|Median
80394|NCT00997321|Secondary|Patient Reported Pain or Recall of the Procedure|"patient completed question after return to baseline mental status did you feel pain during the procedure and do you remember any part of the procedure answered by circling yes or no on a question sheet, positive if yes to either question"|single measurement immediately after patient returns to baseline mental status after sedation procedure|100 patients were randomized, 50 to each group, 50 underwent the procedure in the propofol group and 47 in the ketamine group||percentage of participants||95% Confidence Interval|Number
80395|NCT00997321|Secondary|Time to Return of Baseline Mental Status|time in seconds from the first dose of medication until the patient has regained baseline mental status|from start of procedure until the return of baseline mental status up to 120 minutes|50 patients were randomized to the propofol group and 50 to ketamine, 50 underwent the procedure in the propofol group and 47 in the ketamine group||minutes||95% Confidence Interval|Median
80396|NCT00997321|Primary|Respiratory Depression (Sub-clinical and Clinical Signs)|binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform|From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)|50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm||percentage of participants||95% Confidence Interval|Number
80397|NCT00997243|Secondary|Explore the Biologic Role of microRNAs in Determining Clinical Response to the AZA Plus Lintuzumab Combination and Achievement of the Other Pharmacodynamic Endpoints||Up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
80398|NCT00997243|Secondary|Perform Exploratory Studies of AZA-triphosphate With Global DNA Methylation||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
80399|NCT00997243|Secondary|Provide Preliminary Data on the Biological Activity of AZA as a Demethylating Agent (Changes in Target Gene Methylation and Gene Expression, DNMT1[Deoxyribonucleic Acid Methyltransferase 1 DNA Methyltransferase 1]Protein Expression, Global Methylation)||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
80400|NCT00997243|Secondary|Determine the Relationship Between Pretreatment Expression of Syk and Clinical Response; to Determine Whether the Investigational Agents Modulate Syk Expression and Correlate Drug-induced Changes in Syk With Response to Treatment||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.|||||
80401|NCT00997243|Secondary|Toxicities of the Combination|All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.|up to 5 years|||percentage of participants|||Number
80402|NCT00997243|Secondary|Overall Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years|||percentage of participants|||Number
80403|NCT00997243|Primary|Complete Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years|||percentage of participants|||Number
80404|NCT00997204|Secondary|Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort|Subjects assessed angioedema attack symptoms using the visual analogue scale (VAS) for skin pain, skin swelling and abdominal pain. The VAS is a continuous scale comprised of a 100 mm in length line, anchored by 2 verbal descriptors, one for each symptom extreme 0 (no pain) and 100 (worst pain). The respondent is asked to place a mark on the VAS line (any where between 0 and 100 mm) at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the line between the “no pain” anchor and the patient’s mark, providing a range of scores from 0–100. A higher score indicates greater pain intensity. Score interpretation is: no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), and severe pain (75–100 mm). Symptom relief is defined as at least a 50% reduction in a pre-dose VAS score of 30 mm or greater. The time to onset of symptom relief is defined as the first of 3 consecutive assessments at which symptom relief was observed.|48 hours post-dose|||Hours||Inter-Quartile Range|Median
80422|NCT00996996|Secondary|Number of Participants With Elevated, Low, and Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline|ITT-Exposed Population. Only those participants for whom TSH levels were recorded at Baseline were assessed.||participants|||Number
80405|NCT00997204|Primary|Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant|"Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant was assessed by calculating the number of AEs occurred during the study. Only those adverse events occurring up to the earlier of 7 days from the start of the naive phase, study discontinuation and start of the self-administration phase are assessed.~The Local Tolerability Assessment tool was used. Subjects and Investigators graded erythema/reddening, swelling, burning, pruritus/itching, warm sensation, and skin pain on a 0 to 3 severity scale."|7 days from the beginning of each phase|||participants|||Number
80406|NCT00997139|Primary|MRSA Clearance Rate|Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.|14 days|||percentage of subjects|||Number
80407|NCT00997139|Primary|MSSA Clearance Rate|Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.|14 days|||percentage of subjects|||Number
80408|NCT00997139|Primary|Carrier Rate for Staphylococcus Aureus|Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)|Baseline|||percentage of subjects|||Number
80409|NCT00997126|Secondary|Patient Reported Recall of the Procedure||Single measurement immediately after patient returns to baseline mental status after sedation procedure|||participants|||Number
80410|NCT00997126|Secondary|Patient Reported Pain||Single measurement immediately after patient returns to baseline mental status after sedation procedure|||participants|||Number
80411|NCT00997126|Secondary|Depth of Sedation Measured Using the OAAS Scale|Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli|Single measurement during sedation procedure|||units on a scale||Inter-Quartile Range|Median
80412|NCT00997126|Secondary|Time to Return of Baseline Mental Status From Start of Procedure in Minutes||Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours|||minutes||Inter-Quartile Range|Median
80413|NCT00997126|Primary|Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure||From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)|||participants|||Number
80414|NCT00997113|Secondary|Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure|Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure.|single time point measured after sedation procedure completed|||participants|||Number
80415|NCT00997113|Secondary|Respiratory Depression|categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%.|From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status|||participants|||Number
80416|NCT00997113|Primary|Change in Serum Catecholamines|change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.|one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes|||mcg/ml||Inter-Quartile Range|Median
80417|NCT00996996|Secondary|Number of Participants Who Received Thyroid Medication After Treatment|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population||participants|||Number
80418|NCT00996996|Secondary|Number of Participants With Low or Normal Baseline TSH Levels That Developed Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal Baseline TSH levels were assessed.||participants|||Number
80419|NCT00996996|Secondary|Number of Participants With the Adverse Event (AEs) of Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication. An AE is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom, or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered to be related to the medical treatment or procedure, that occurs during the course of the study.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population||participants|||Number
80420|NCT00996996|Secondary|Time to Elevated TSH Post Baseline for Participants Who Had Low or Normal TSH Levels at Baseline and Elevated Levels Post Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were categorized to have elevated or normal/low TSH values per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal TSH levels at Baseline and elevated levels post Baseline were assessed.||months||Full Range|Median
80421|NCT00996996|Secondary|Participants With Elevated TSH Levels at Baseline With Post Baseline TSH Levels of Low/Normal and Elevated|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants with elevated TSH levels at Baseline were assessed.||participants|||Number
81673|NCT00987402|Secondary|Cost of Hand Preparation Agent|Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.|30 days||||||
80423|NCT00996996|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who converted from being negative for HAMA at Baseline to being positive for HAMA any time following treatment were assessed.||days||Standard Deviation|Mean
80424|NCT00996996|Secondary|Number of Participants With Conversion to HAMA Positivity Any Time During the Study From Baseline|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who were evaluable for HAMA were assessed.||participants|||Number
80425|NCT00996996|Secondary|Number of Participants Evaluable and Not Evaluable for Human Anti-Murine Antibodies (HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population||participants|||Number
80426|NCT00996996|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE)|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. A fatal SAE is a medical event that results in death.|From Baseline up to 12 years from the start of treatment (long-term follow up)|ITT-Exposed Population||participants|||Number
80427|NCT00996996|Secondary|Normal Organ Dosimetry for the Indicated Organs|Organ dosimetry was performed in participants using the kidneys, liver, lungs, spleen, red marrow, urinary bladder, and the remainder of the body as source organs. Organ doses and Iodine I-131 Anti-B1 Antibody biodistribution were comparable across the three Anti-B1 Antibody manufacturers. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). For the spleen (corrected) category, participant-specific corrections were made to account for individual spleen size.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants who had available gamma camera images for the indicated organs were assessed.||cGy/75 cGy total body dose (TBD)||Standard Deviation|Mean
80428|NCT00996996|Secondary|Total Body Effective Half-life (EHL)|Total body EHL is the time required for a radioactive element in the body to be diminished by 50% as a result of radioactive decay and biologic elimination. The EHL is equal to the product of the biologic half-life (BHL) and the radioactive half-life (RHL) divided by the sum of the BHL and the RHL: EHL=(BHL * RHL)/(BHL + RHL). BHL is the time it takes for a drug to lose half of its pharmacologic, physiologic, or radiologic activity. RHL is the time taken for half of the radioactive nuclei to decay.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population||hours||Standard Deviation|Mean
80429|NCT00996996|Secondary|Volume of Distribution at Infusion Time 0 (Vd0) and Steady State (Vdss)|Volume of distribution at the start of infusion and at steady state of I-131 tositumomab. The volume of distribution measures how much the drug spreads through the body after the dose. Steady state is defined as that state at which the overall intake of a drug is fairly in dynamic equilibrium with its elimination.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||milliliters (ml)||Standard Deviation|Mean
80430|NCT00996996|Secondary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed I-131 tositumomab concentration from time zero (end of the dosimetric dose infusion) to 120 hours after the end of the infusion. Unit: %ID/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. Cmax is the highest drug concentration in the blood after infusion.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||%ID/ml||Standard Deviation|Mean
80431|NCT00996996|Secondary|Clearance Values|Clearance of I-131 tositumomab after intravenous administration was measured. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||Milliliters per hour (ml/hr)||Standard Deviation|Mean
80432|NCT00996996|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours and 0 to Infinity Hours|Area under the concentration-time curve for I-131 tositumomab from time 0 to 120 hours and time 0 to infinity hours (extrapolated) after the end of the dosimetric dose infusion was measured. Unit: %ID*h/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours and 0-infinity hours from the dosimetric dose (given only on Day 0) and 0-120 hours and 0-infinity hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||%ID*h/ml||Standard Deviation|Mean
80433|NCT00996996|Secondary|Terminal Half-life (t1/2beta)|t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||hours||Standard Deviation|Mean
80434|NCT00996996|Secondary|Initial Half-life (t1/2alpha)|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.||hours||Standard Deviation|Mean
80435|NCT00996996|Secondary|Progression-free Survival (PFS) Based on Participants’ Baseline PCR Status|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent. PFS is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR status taken at Baseline were evaluated for PFS.||months||95% Confidence Interval|Median
80436|NCT00996996|Secondary|Duration of Response (the Time From the First Documented Response to the First Documented Progression) for Participants Who Were PCR Positive at Baseline and Converted to PCR Negative Status After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who were PCR positive at Baseline and converted to a status of PCR negative were assessed.||months||95% Confidence Interval|Median
80437|NCT00996996|Secondary|Number of Participants Who Were Polymerase Chain Reaction (PCR)-Positive at Baseline With Bone Marrow Conversion to a Status of PCR Positive and Negative Any Time After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR-positive status at Baseline were assessed. One participant had a Baseline measurement but no post Baseline measure, and was thus not assessed.||participants|||Number
80438|NCT00996996|Secondary|Number of Participants With Resolution of All Baseline B-symptoms by the End of the Study|"The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (called B-symptoms) are present, a B classification is added to the stage: night sweats, intermittant fever, and weight loss. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas."|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced any B-symptom at Baseline were assessed. Not all participants experienced all B-symptoms at Baseline; thus, the number of participants analyzed represents all participants who experienced at least one B-symptom.||participants|||Number
80439|NCT00996996|Secondary|Time to Progression of Disease or Death (Progression-free Survival)|Time to progression is defined as the time from the treatment start date to the first documented progression or death. Progressive Disease is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced disease progression or died were assessed.||months||95% Confidence Interval|Median
80440|NCT00996996|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who died during the study due to any cause were assessed.||months||95% Confidence Interval|Median
80441|NCT00996996|Secondary|The Estimated Value Represents the Percentage of Participants With a PR|Duration of response (CR, CCR, or PR) is defined as the time from the first documented response to the first documented progression. Progressive Disease (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants who experienced confirmed CR, CCR, or PR with PD were assessed. Response (R) had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented.||months||95% Confidence Interval|Median
80442|NCT00996996|Primary|Number of Participants With Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population||participants|||Number
85129|NCT00953615|Secondary|Overall Toxicity and Tolerability|Overall toxicity and tolerability were to be measured by the number of patients with development of neuropathy, increased liver biochemistries, drowsiness, dizziness and orthostatic hypotension.|6 months|||participants|||Number
80443|NCT00996996|Primary|Number of Participants With Confirmed Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|Responses were confirmed by two separate response evaluations at least 4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants evaluable for confirmed response (R) were assessed. R had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented in the table.||participants|||Number
80444|NCT00996996|Primary|Number of Participants With Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), or Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population||participants|||Number
80445|NCT00996996|Primary|Number of Participants With Confirmed Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|Confirmed response required CR, CCR, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population: all participants who were enrolled in the study and received at least one dose of study drug. Only participants evaluable for confirmed response were assessed.||participants|||Number
80446|NCT00996944|Secondary|Drug Clearance Rate On-Dialysis and Off-Dialysis During the Maintenance Dose Treatment Phase (in the Long-term Treatment Period)|For on-dialysis analysis, measurements were to have been taken 1 hour before dialysis, in the artery/vein at the beginning, during, and end of dialysis, and 1 hour after dialysis. For off-dialysis analysis, measurements were to have been taken 1 hour before dialysis, at the beginning, during, and end of dialysis, and 1 hour after dialysis.|Week 12 through Week 64|PK analysis was not performed because there were no participants (who had received a maintenance dose of the IP for more than 1 week in the long-term treatment period) from whom a blood sample could be collected when decision of study termination was made.|||||
80447|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|LONG WD (up to Week 64)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the and LONG WD data.||hours||Standard Deviation|Mean
80448|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|DBT WD (up to Week 12)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the DBT WD data.||hours||Standard Deviation|Mean
80449|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|Week 0 and Week 12|FAS. Participants without symptoms were not included in the analysis of Week 0 data. Participants without symptoms and participants prematurely withdrawn from the study were not included in the analysis of Week 12 data.||hours||Standard Deviation|Mean
80450|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.||participants|||Number
80451|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||participants|||Number
80452|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||participants|||Number
80453|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||units on a scale||Standard Deviation|Mean
80454|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in this analysis.||units on a scale||Standard Deviation|Mean
80455|NCT00996944|Secondary|The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||units on a scale||Standard Deviation|Mean
80456|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||units on a scale||Standard Deviation|Mean
80457|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.||units on a scale||Standard Deviation|Mean
80458|NCT00996944|Primary|IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12, and 2 participants had missing DBT WD data.|DBT WD (up to Week 12)|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.||units on a scale||Standard Deviation|Mean
80459|NCT00996944|Secondary|Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||units on a scale||Standard Deviation|Mean
80460|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.||participants|||Number
80461|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.||participants|||Number
80462|NCT00996944|Secondary|Number of Participants With the Indicated Clinical Global Impression–Improvement (CGI-I) Scores at Week 12|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.||participants|||Number
80463|NCT00996944|Secondary|IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS.|LONG WD (up to Week 64)|FAS. One participant in each group had no measurement data and thus was not included in the analysis. These two participants were withdrawn from the study without receiving the IP in the long-term treatment period.||units on a scale||Standard Deviation|Mean
80464|NCT00996944|Primary|International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12.|Week 0 and Week 12|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.||units on a scale||Standard Deviation|Mean
80465|NCT00996931|Secondary|Change in Childhood Autism Rating Scale (CARS)Value From Baseline to 6 Weeks|Change in CARS value from baseline to 6 weeks. Total CARS scores range from a fifteen to 60, with a minimum score of thirty serving as the cutoff for a diagnosis of autism on the mild end of the autism spectrum.|Baseline and 6 weeks|Intention to treat||mean change in units on scale||Standard Deviation|Mean
80466|NCT00996931|Primary|Change in TNF-alpha Levels|Change in CSF-TNF-α from baseline to 12 weeks.|Baseline and 12 weeks|Intention to treat||mean % change||Standard Deviation|Mean
80467|NCT00996918|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state|Weeks 6, 19, 32, 45 and 78|||Units on a scale||Standard Error|Least Squares Mean
80468|NCT00996918|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Weeks 6, 19, 32, 45 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80469|NCT00996918|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80470|NCT00996918|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80477|NCT00996892|Secondary|Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B|Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.|||||
80471|NCT00996918|Secondary|Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78|The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80472|NCT00996918|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80473|NCT00996918|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80474|NCT00996918|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.||Units on a scale||Standard Error|Least Squares Mean
80475|NCT00996918|Primary|Number of Participants Reporting a Serious Adverse Event.|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|The Safety Population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).||Number of participants|||Number
80476|NCT00996892|Secondary|Progression-Free Survival (PFS) - Dose Escalation Stages 1, 1A and 1B|PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.|||||
80501|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80478|NCT00996892|Secondary|Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B|Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
80479|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80480|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80481|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80482|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80483|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80484|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80485|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80486|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80487|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80488|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80489|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80490|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80491|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80492|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80493|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80494|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80495|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80496|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80497|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
80498|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80499|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80500|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
88691|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
80502|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80503|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80504|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80505|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80506|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
80507|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80508|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80509|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80510|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80511|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80512|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 2 All Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80513|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80514|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80515|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
80516|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80517|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80523|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
80524|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80525|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80526|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80527|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80528|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80529|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80530|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80531|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
80532|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80533|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80534|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80535|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80536|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80537|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80538|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80539|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80540|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
81674|NCT00987337|Secondary|Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin||Week 0 (pre-dose), Week 2, 4, 8, 12, 16, 20, 24, 48 (only for those participants who received treatment till Week 48) post-dose|Data could not be summarized due to sparse sampling time points adopted for this study.|||||
80541|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80542|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80543|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80544|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80545|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80546|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80547|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80548|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80549|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
80550|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Geometric Coefficient of Variation|Geometric Mean
80551|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80552|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80553|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80554|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80555|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
83103|NCT00975195|Secondary|Time to First On-treatment COPD Exacerbation|"Time to first on-treatment COPD exacerbation of any severity. The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set||days||95% Confidence Interval|Number
80556|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80557|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80558|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ratio||Geometric Coefficient of Variation|Geometric Mean
80559|NCT00996892|Secondary|Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
80560|NCT00996892|Secondary|Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Geometric Mean
80561|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80562|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80563|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80564|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80565|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80566|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80567|NCT00996892|Primary|AUC0-24 of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80568|NCT00996892|Primary|Cmax of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80569|NCT00996892|Primary|Tmax of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80570|NCT00996892|Primary|Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||nonograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
88692|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
80571|NCT00996892|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
80572|NCT00996892|Primary|Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4|Pharmacokinetic (PK) population included all participants who had at least one cobimetinib and pictilisib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
80573|NCT00996892|Primary|Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B|MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non–hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants evaluable for specified categories.||mg|||Number
80574|NCT00996892|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B|DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non–hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population included all participants who received at least one dose of study drug. Here, number of participants analyzed = participants who were evaluable for this outcome.||participants|||Number
80575|NCT00996801|Primary|Number of Participants With Predefined Tier 1 Adverse Events|Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.||Participants|||Number
80576|NCT00996801|Primary|Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a Tier 1 AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons)."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.||Participants|||Number
80577|NCT00996801|Primary|Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a Tier 1 adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.||Participants|||Number
80578|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Osteocalcin|"Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter~(mL)."|Baseline and Month 12|Analysis of osteocalcin was not conducted when it was determined that the efficacy of MK-5442 was not significantly different than placebo.|||||
80579|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80580|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)|s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80604|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
80581|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml).|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80582|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)|"Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine.~uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr"|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80583|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcomes analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80584|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80585|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80586|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine|vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80587|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80588|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80589|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80605|NCT00996658|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication. Three subjects in each arm excluded for site non-compliance.||Participants|||Number
80590|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80591|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80592|NCT00996801|Primary|Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)|"Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."||percent change||95% Confidence Interval|Least Squares Mean
80593|NCT00996775|Primary|Reduction in Percentage of Heavy Drinking Days|"reduction in the percentage of heavy drinking days over the prior 30-days.~a heavy drinking day was defined as drinking above gender-matched NIAAA drinking limits (e.g., greater than 4 drinks on one occasion for men)."|baseline to six-month follow-up|||percentage of heavy drinking days||Standard Deviation|Mean
80594|NCT00996736|Secondary|Microbiological Cure at 6 Days|Microbiological cure defined as no fungal growth on culture at 6 (+/-1) days from enrollment|7 days after enrollment|||participants|||Number
80595|NCT00996736|Secondary|Minimum Inhibitory Concentration of Isolates|Minimum inhibitory concentration (50th percentile) of fungal isolates to natamycin and voriconazole|3 months after enrollment|The population for analysis included only those subjects with positive fungal cultures and for whom Minimum Inhibitory Concentrations were available (108 subjects who were randomized to natamycin and 113 who were randomized to voriconazole).||μg/ml||95% Confidence Interval|Mean
80596|NCT00996736|Secondary|Time to Resolution of Epithelial Defect|Time in days from enrollment to resolution of epithelial defect. For those subjects with more than 21 days to resolution, 21 days was used.|From enrollment to the time of resolution of epithelial defect|||days||Standard Deviation|Mean
80597|NCT00996736|Secondary|Size of Infiltrate/Scar|Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate|3 weeks and 3 months after enrollment|||mm||95% Confidence Interval|Mean
80598|NCT00996736|Secondary|Hard Contact Lens-corrected Visual Acuity Measured in logMAR|Hard contact lens-corrected visual acuity measured in logMAR (logarithm of the Minimum Angle of Resolution) 3 months after enrollment|3 months after enrollment|||logMAR||95% Confidence Interval|Mean
80599|NCT00996736|Secondary|Best Spectacle-corrected logMAR Visual Acuity|Best spectacle-corrected logMAR (logarithm of the Minimum Angle of Resolution) visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model|3 weeks after enrollment|306 total subjects (155 in natamycin arm, 151 in voriconazole arm) returned after enrollment for a second visit, but only 293 of those (149 in natamycin arm and 144 in voriconazole arm) visited within the 3-week window (2.5-5 weeks). Only those who visited within the window were included in the analysis.||logMAR||95% Confidence Interval|Mean
80600|NCT00996736|Primary|Best Spectacle-corrected logMAR Visual Acuity|The primary analysis is best spectacle-corrected logMAR (logarithm of the Minimum Angle or Resolution) visual acuity, correcting for enrollment BSCVA and treatment arm in a multiple linear regression model. The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
80601|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
80602|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
80603|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
80606|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=6.5% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.||Participants|||Number
80607|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=7.0% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.||Participants|||Number
80608|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
80609|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
80610|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
80611|NCT00996658|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.||Percentage||Standard Error|Least Squares Mean
80612|NCT00996632|Secondary|Time of Discharge|evaluation about the time of discharge from hospital|days|||Days||Standard Deviation|Mean
80613|NCT00996632|Primary|Drainage Volume|volume in milliliters of axillary drainage|discharge day|the number of participants for analysis was determined by mean of power sample size calculation||milliliters||Standard Deviation|Mean
80614|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis|Ntotal and ME were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of NtotalME was expressed as voxels times ratio of signal intensity before and after contrast injection (v*ratio). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||v*ratio||Standard Deviation|Mean
80615|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis|Ntotal and IRE were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of IRE. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of Ntotal×IRE was expressed as voxels times change in relative intensity per second (v*ΔI/sec). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||v*ΔI/sec||Standard Deviation|Mean
80616|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis|Nwashout was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nwashout. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||washout enhancing voxels||Standard Deviation|Mean
80617|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis|Nplateau was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nplateau. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||plateau enhancing voxels||Standard Deviation|Mean
80618|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis|Npersistent was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Npersistent. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||persistent enhancing voxels||Standard Deviation|Mean
80631|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-17 Level|Level of IL-17 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80619|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis|Ntotal was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||enhancing voxels||Standard Deviation|Mean
80620|NCT00996606|Secondary|Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis|ME was approximated by parametric mapping via DYNAMIKA software and expressed as ratio of signal enhancement before and after contrast injection. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||ratio||Standard Deviation|Mean
80621|NCT00996606|Secondary|Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis|IRE was approximated by parametric mapping via DYNAMIKA software and expressed as change in relative signal intensity per second (ΔI/sec). The mean of three different slices was used in the determination of IRE. Each slice consisted of a two-dimensional (2D) sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||ΔI/sec||Standard Deviation|Mean
80622|NCT00996606|Secondary|Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration|Level of STR was measured in pg/mL. Baseline AV and changes from Baseline to Day 2 and Weeks 2 and 4 were averaged among all participants.|Baseline; Day 2; and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80623|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration|Level of Hb was measured in grams per liter (g/L). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||g/L||Standard Deviation|Mean
80624|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level|Level of HELIX-II was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80625|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level|Level of PIIANP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80626|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level|Level of ICTP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80627|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level|Level of CTX-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80628|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level|Level of Type I collagen N-propeptide was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80629|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Osteocalcin Level|Level of osteocalcin was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80630|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level|Level of MCaP-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80841|NCT00995865|Secondary|Distribution of Geometric Mean Antibody Titers (GMTs) to Yellow Fever 17D Virus.|Geometric mean antibody titers (GMT) neutralizing antibody titers for each dose groups.|GMT titers measured at days 21, 31 and 42 for different dose rates.|||Geometric Antibody titers||95% Confidence Interval|Geometric Mean
80632|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-1β Level|Level of IL-1β was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80633|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level|Level of TNF-α was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80634|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level|Level of APRIL was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80635|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level|Level of BAFF was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80636|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level|Level of SDF1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80637|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level|Level of BCA was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80638|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80639|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80640|NCT00996606|Secondary|Change From Baseline to Week 4 in Plasma B Cell Level|The absolute number of plasma B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
80641|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells|The intensity of plasma B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
80642|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs|The intensity of plasma B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80643|NCT00996606|Secondary|Change From Baseline to Week 4 in Transitional B Cell Level|The absolute number of transitional B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
80644|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells|The intensity of transitional B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
80682|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level|Level of mRNA for IL-23 receptor (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
80645|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs|The intensity of transitional B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80646|NCT00996606|Secondary|Change From Baseline to Week 4 in Memory B Cell Level|The absolute number of memory B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
80647|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells|The intensity of memory B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
80648|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs|The intensity of memory B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80649|NCT00996606|Secondary|Change From Baseline to Week 4 in Mature B Cell Level|The absolute number of mature B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
80650|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells|The intensity of mature B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of B cells||Standard Deviation|Mean
80651|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs|The intensity of mature B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80652|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence|The mean fluorescence intensity of IgM-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80653|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs|The intensity of IgM-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80654|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD38-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80655|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs|The intensity of CD38-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80656|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD27-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80657|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs|The intensity of CD27-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80658|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD24-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80659|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs|The intensity of CD24-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80660|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80661|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs|The intensity of CD19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80662|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cell Level|The absolute number of Th17 cells was expressed as cells/mcL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
80663|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells|The intensity of Th17 cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of T cells||Standard Deviation|Mean
80664|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs|The intensity of Th17 cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80665|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cell Level|The absolute number of Treg cells was expressed as cells per microliter (cells/mcL). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||cells/mcL||Standard Deviation|Mean
80666|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells|The intensity of Treg cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of T cells||Standard Deviation|Mean
80667|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs|The intensity of Treg cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80668|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence|The mean fluorescence intensity of IL-23Rp19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80669|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs|The intensity of IL-23Rp19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80709|NCT00996593|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||G/dL||Full Range|Median
80670|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80671|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs|The intensity of CCR4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80672|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR6-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80673|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs|The intensity of CCR6-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80674|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence|The mean fluorescence intensity of CD45RO-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80675|NCT00996606|Secondary|"Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs"|The intensity of CD45RO-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80676|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD25-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80677|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs|The intensity of CD25-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80678|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||fluorescence intensity units||Standard Deviation|Mean
80679|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs)|The intensity of CD4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percentage of PBMCs||Standard Deviation|Mean
80680|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level|Level of mRNA for FOXP3 (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
80681|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level|Level of ROR-γT (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
81023|NCT00993421|Secondary|Change in Fasting Glucose From Baseline to 24 Weeks Endpoint|Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
80683|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level|Level of mRNA for IL-17 (2^ΔCt) was quantified by polymerase chain reaction (PCR). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||2^ΔCt||Standard Deviation|Mean
80684|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level|Level of sIL6R was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80685|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration|Level of hsCRP was measured in mg/dL. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||mg/dL||Standard Deviation|Mean
80686|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR)|ESR was measured in millimeters per hour (mm/h). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||mm/h||Standard Deviation|Mean
80687|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration|Level of VEGF was measured in picograms per milliliter (pg/mL). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||pg/mL||Standard Deviation|Mean
80688|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score|The DAS28 was derived from assessments of C-reactive protein (CRP), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] plus (+) [0.28 × square root of SJC] + [0.36 × natural log (CRP + 1)] + [0.014 × VAS] + 0.96. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. CRP was measured in milligrams per deciliter (mg/dL). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||units on a scale||Standard Deviation|Mean
80689|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assessed 20 items in eight functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score was calculated as an average of all item scores, and thus also ranged from 0 to 3. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an increase in ability to perform activities independently.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||units on a scale||Standard Deviation|Mean
80690|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score|Global assessment of disease activity was performed using a 0- to 100-mm VAS, where the distance from 0 mm represented the investigator's evaluation or the participant's self evaluation of disease activity (0 mm = no pain, 100 mm = maximum pain). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||mm||Standard Deviation|Mean
80691|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score|Perceived pain was assessed on a 0- to 100-millimeter (mm) VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm = no pain, 100 mm = maximum pain). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated a decrease in perceived pain.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||mm||Standard Deviation|Mean
80692|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score|The Ritchie Articular Index was scored on a scale of 0 to 3, according to the grades of tenderness in each of 26 assessed joints. The total score was taken as the sum of joint scores and ranged from 0 to 78. Scores of 0 reflected no tenderness, while higher scores reflected increased tenderness. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in joint tenderness.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.||units on a scale||Standard Deviation|Mean
80967|NCT00993668|Secondary|Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80693|NCT00996606|Secondary|Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS)|The TMSS was calculated as the sum of ES and JSNS and ranged from 0 to 202. The ES was taken as the sum of joint scores collected for 14 joints in each hand (individually scored from 0 to 7) and ranged from 0 to 98 for both hands. The JSNS was the sum of joint scores collected for 13 joints in each hand (individually scored from 0 to 8) and ranged from 0 to 104 for both hands. Scores of 0 reflected no change, while higher scores reflected increased disease activity. Baseline AV and changes from Baseline to Weeks 24 and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
80694|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 45) and MCP joints (range, 0 to 24). Aggregate wrist and MCP joint scores could range from 0 to 69 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
80695|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. The number of bones with edema was taken as the count of joints with a bone edema score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||bones with bone marrow edema||Standard Deviation|Mean
80696|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to 10% increase in extent of erosion. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 150) and MCP joints (range, 0 to 80). Aggregate wrist and MCP joint scores could range from 0 to 230 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
80697|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to a 10% increase in extent of erosion. The number of bones with erosion was taken as the count of joints with a bone erosion score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||bones with erosion||Standard Deviation|Mean
80698|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Synovitis of MCP joints was determined on the basis of Short Inversion Time Inversion Recovery (STIR) sequence evaluation with modification of the RAMRIS score. Four MCP joint compartments were each assessed 0 to 3, so the aggregated MCP joint score ranged from 0 to 12. Combined synovitis in wrist and MCP joints was determined on the basis of STIR sequences to produce overall score from 0 to 21. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
80699|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection|REE per second was calculated as [S55 – S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent rate of early enhancement||Standard Deviation|Mean
80700|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection|RE was calculated as [S0 – S55] ÷ S0 × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent relative enhancement||Standard Deviation|Mean
80701|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
80702|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection|REE per second was calculated as [S55 – S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent rate of early enhancement||Standard Deviation|Mean
80703|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection|RE was calculated as [S0 minus (–) S55] divided by (÷) S0, multiplied by (×) 100 percent (%), where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||percent relative enhancement||Standard Deviation|Mean
80704|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score|Synovitis of the wrist was assessed at three sites including the radioulnar joint (RUJ), the radiocarpal joint (RCJ), and the intercarpal-carpometacarpal joints (IC-CMCJ). Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Baseline absolute value (AV) and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."||units on a scale||Standard Deviation|Mean
80705|NCT00996593|Primary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
80706|NCT00996593|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed.||days||Full Range|Median
80707|NCT00996593|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||participants|||Number
80708|NCT00996593|Secondary|Nadir Values for Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||cells/microliter||Full Range|Median
86395|NCT00943592|Secondary|Overall Survival (OS)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
80710|NCT00996593|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||cells/millimeters cubed (mm^3)||Full Range|Median
80711|NCT00996593|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||days||Full Range|Median
80712|NCT00996593|Secondary|Number of Participants With Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants who experienced any SAE were analyzed.||participants|||Number
80713|NCT00996593|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.||participants|||Number
80714|NCT00996593|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||participants|||Number
80715|NCT00996593|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population||participants|||Number
80716|NCT00996593|Primary|Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who experienced progression were evaluated.||months||95% Confidence Interval|Median
80717|NCT00996593|Primary|Progression-free Survival for Participants With or Without a Prior Response to Rituximab|Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.||months||95% Confidence Interval|Median
80718|NCT00996593|Primary|Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.||months||95% Confidence Interval|Median
80719|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.||participants|||Number
80720|NCT00996593|Primary|Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with a response were analyzed.||months||95% Confidence Interval|Median
80721|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study|Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.||participants|||Number
80722|NCT00996593|Primary|Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator|Response duration is defined as the time from the first documented response until progressive disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
80723|NCT00996593|Primary|Duration of Response for CR and CCR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR + CCR response and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
80724|NCT00996593|Primary|Duration of Response for Confirmed CR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
80725|NCT00996593|Primary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
80726|NCT00996593|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.||participants|||Number
80727|NCT00996593|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.||participants|||Number
80728|NCT00996593|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
80729|NCT00996593|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
80730|NCT00996580|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication||pregnancies / cumulative exposure||95% Confidence Interval|Number
80902|NCT00994760|Secondary|Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)|5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases."||units on a scale||Standard Deviation|Mean
80731|NCT00996580|Primary|Summary of Participants With Treatment-emergent Adverse Events|"The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date.~Relationship to study drug was assessed by the investigator.~Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Day 1 up to 13 months|Safety population of treated participants||participants|||Number
80732|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
80733|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods including condoms were used.||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
80734|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 28-day cycle.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
80735|NCT00996580|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.||pregnancies / cumulative exposure||95% Confidence Interval|Number
80736|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
80748|NCT00996476|Primary|The Percentage of Participants With Sustained Virologic Response (SVR)|"The table below shows the percentage of participants with a SVR4, SVR12, and SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT) (up to Weeks 24 or 48) and at 4, 12, and 24 weeks, respectively, after the last dose of treatment. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|SVR4 (up to Week 28 or Week 52), SVR12 (up to Weeks 36 or 60), and SVR24 (up to Weeks 48 or 72)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
80737|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods including condoms were used.||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
80738|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
80739|NCT00996502|Secondary|Proportion of Patients Alive at One Year (Phase II)||One year||||||
80740|NCT00996502|Secondary|Overall Survival Rate||2 years||||||
80741|NCT00996502|Secondary|Objective Response Rate at the Recommended Phase II Dose Level of Docetaxel, Bevacizumab, Erlotinib, and Prednisone||Every 9 weeks||||||
80742|NCT00996502|Primary|Maximum Tolerated Dose of Docetaxel in Combination With Erlotinib, Bevacizumab, and Prednisone (Phase I)||After three 21-day cycles|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.|||||
80743|NCT00996476|Primary|The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications|"The table below shows the number of participants who met response-guided treatment (RGT) stopping criteria in the TMC435 treatment groups. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20 were to stop all study medication (TMC435, PegIFNα-2a, and ribavirin) at Week 24. All other participants continued PegIFNα-2a and ribavirin until Week 48. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
80744|NCT00996476|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|"The table below shows the median time in hours to reach the maximum plasma concentration (tmax) of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.||Hours||Full Range|Median
80745|NCT00996476|Primary|The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435|"The table below shows the mean AUC24 of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.||ng∙h/mL||Standard Deviation|Mean
80746|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling)|"The table below shows the mean predose plasma concentration (C0h) for participants in the 2 TMC435 50 mg treatment groups combined and for participants in the 2 TMC435 100 mg treatment groups combined who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4 to 6|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Standard Deviation|Mean
80747|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling)|"The table below shows the mean (standard deviation) predose plasma concentration (C0h) for participants in each treatment group at Weeks 4, 12, and 24. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, and 24|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.||ng/mL||Standard Deviation|Mean
80749|NCT00996476|Primary|The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT)|"The table below shows the number of participants whose ALT results were within the normal range on Day 1 (initial day of treatment), Week 24, 48, and EOT (up to Weeks 24 or 48).The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1, Weeks 24, 48, and EOT (up to Weeks 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
80750|NCT00996476|Primary|Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period|"The table below shows the mean (standard deviation) of the actual HCV RNA values by treatment group at Baseline and Weeks 4, 12, 24, 48, end of treatment (EOT, up to Weeks 24 or 48), Weeks 60 and 72 (Week 24 in the post-treatment follow-up period). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Baseline, Week 4, 12, 24, 48, EOT (up to Week 24 or 48), and Weeks 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||log10 IU/mL||Standard Deviation|Mean
80751|NCT00996476|Primary|The Percentage of Participants With Viral Relapse|"The table below shows the percentage of participants in each treatment group who experienced viral relapse within 12 weeks (ie, at Week 36 or 60) after actual end of treatment (EOT) (up to Week 24 or 48). Viral relapse was defined as confirmed detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels during the post treatment follow-up period at Weeks 36 or 60 in participants with undetectable plasma HCV RNA at EOT. The statistical analysis shows the difference in treatments (ie, each TMC435 group minus PR48 control) in viral relapse. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
80752|NCT00996476|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the 48 week treatment period with at least one study medication (TMC435 or PegIFNα-2a and ribavirin). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to EOT (up to Week 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Participants|||Number
80753|NCT00996476|Primary|The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up|"The table below shows the percentage of participants in each treatment group with plasma HCV RNA levels undetectable or below the limit of quantification (<1.2 log10 IU/mL detectable ) at time points during treatment and post treatment follow-up.The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 4, 12, 24, 36, 48, EOT (up to Week 24 or 48), and Week 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
80754|NCT00996476|Primary|The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period|"The table below shows the percentage of participants in each treatment group with a decrease of greater than (>) or equal (=) to 2 log10 IU/mL from baseline in plasma HCV RNA levels at time points during the treatment period and post treatment follow-up period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Days 1 (4 hr), 1 (8 hr), 3, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24,28, 36, 42, 48, 52, 60, 72, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
80807|NCT00996203|Secondary|Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of Participants|||Number
80755|NCT00996476|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study|"The table below shows the percentage of participants in each treatment group with undetectable plasma HCV RNA levels at Weeks 4, 12, 24, 48, and end of treatment (EOT, up to Week 24 or 48). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed.NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24 or 48, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||Percentage of participants|||Number
80756|NCT00996476|Primary|Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4|"The table below shows the least-squares (LS) mean change and 95% confidence intervals (CI) change from baseline at Week 4 in HCV RNA levels for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg). The statistical analyses show the difference in LS mean change from baseline from the PR48 control group and the 95% CI for each dose group (ie, each TMC435 dose group minus PR48 control). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1 (Baseline) and Week 4|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.||log10 IU/mL||95% Confidence Interval|Least Squares Mean
80757|NCT00996437|Secondary|Very Severe Visual Acuity Loss (Defined as <20/800)||4,8 and 12 weeks|Participants with a completed 4, 8 and 12 week visit respectively and an available visual acuity measurement were included in the analysis.||percentage of participants|||Number
80758|NCT00996437|Secondary|Severe Visual Acuity Loss (Defined as <20/200)||4,8 and 12 weeks|Participant with a completed 4,8 and 12 week visit and an available visual acuity measurement were included in this analysis.||percentage of participants|||Number
80759|NCT00996437|Secondary|Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit||4, 8 and 12 weeks|This analysis followed the intent-to-treat principle. It includes all randomized eyes with a completed 4, 8 and 12 week visit respectively and an available visual acuity measure.||percentage of participants|||Number
80760|NCT00996437|Secondary|Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status|Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.|4, 8 and 12 weeks|Number of participants with a complete 4 week visit, 8 and 12 week respectively and an available visual acuity measurement.||letter scores||Standard Deviation|Mean
80761|NCT00996437|Secondary|Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength|Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.|4, 8 and 12 weeks|This analysis followed the intent-to-treat principle||percentage of eyes|||Number
80762|NCT00996437|Secondary|Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy|"The proportion of eyes with complete panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test."|within 112 days of randomization|The secondary analysis followed the intent-to-treat principle and included all randomized eyes.||percentage of eyes|||Number
80763|NCT00996437|Primary|Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)||Baseline to 16 weeks|Adverse events for each participants was collected throughout study duration.||participants|||Number
80764|NCT00996437|Primary|"Treatment or Failure Defined as Vitrectomy"|The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.|within 112 days of randomization|The primary analysis followed the intent-to-treat principle and included all randomized eyes.||percentage of participants|||Number
80765|NCT00996372|Secondary|Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)|The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).|change from baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Least Squares Mean
80766|NCT00996372|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire).|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.||units on a scale||Standard Deviation|Mean
80808|NCT00996203|Secondary|General Health Score as Assessed by EQ-5D VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mm||Standard Deviation|Mean
80767|NCT00996372|Primary|Change From Baseline in the Number of Satisfying Sexual Events|A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.||sexual events||Standard Deviation|Mean
80768|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Temsirolimus|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month|||milligrams|||Number
80769|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Irinotecan|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month|||milligrams/meter squared|||Number
80770|NCT00996333|Secondary|Toxicity Assessment|Data was not analyzed because original PI left institution before data analysis was completed.|Every month||||||
80771|NCT00996333|Secondary|Determine Overall and One Year Survival Rates|Data was not analyzed because original PI left institution before data analysis was completed.|One year||||||
80772|NCT00996333|Primary|To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks||||||
80773|NCT00996307|Secondary|Antibody Persistence by Geometric Mean Titers (GMT)||6 months and 12 months after second vaccination|The analysis was done on the subgroup of the per-protocol set (PPS).||Titer||95% Confidence Interval|Geometric Mean
80774|NCT00996307|Secondary|Antibody Persistence 6 Months and 12 Months After the Second Vaccination||6 months and 12 months after second vaccination|The analysis was done on the subgroup of the per-protocol set (PPS).||Percentage||95% Confidence Interval|Number
80775|NCT00996307|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity||up to Day 43|The analysis was done on the subgroup of the per-protocol set (PPS).||Titres||95% Confidence Interval|Geometric Mean
80776|NCT00996307|Secondary|Antibody Response Based on Baseline Seropositivity||up to Day 43|The analysis was done on the subgroup of the per-protocol set (PPS).||Percentage||95% Confidence Interval|Number
80777|NCT00996307|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010||Past 12 months|The analysis was done on the subgroup on the per-protocol set (PPS).||Titers||95% Confidence Interval|Geometric Mean
80778|NCT00996307|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.|Past 12 months|The analysis was done on the subgroup of the per-protocol set(PPS).||Percentage||95% Confidence Interval|Number
80779|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination||Day 22 to 28|The analysis was done on the safety set.||Participants|||Number
80780|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination||Day 1 to 7|The analysis was done on the safety set.||Participants|||Number
80781|NCT00996307|Secondary|Immunogenicity Measurement by Geometric Mean Titers (GMT)|The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667.(based on CBER guidance against the licensed comparator). Moreover the superiority hypothesis was tested using a margin of 1.|21 days after each vaccination|The analysis was done on the Full Analysis Set (FAS).||Titer||95% Confidence Interval|Geometric Mean
80782|NCT00996307|Primary|Antibody Responses After the First and Second Vaccinations|"CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two-sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.~CHMP Criteria: Percentage of subjects with seroconversion for HI antibody is >40%; percentage of subjects achieving an HI titer ≥1:40 is > 70%; and the Geometric Mean Ratio (GMR) is >2.5."|21 days after each vaccination|The analysis was done on the per-protocol set (PPS).||Percentage||95% Confidence Interval|Number
80783|NCT00996281|Secondary|Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)|Serum creatinine was measured at every visit and evaluated as a laboratory parameter of special interest. The percentage of participants with creatinine increase ≥50% from Baseline and greater than ULN was summarized: - At any visit (includes transient and persistent elevations). - At the Final Visit (includes persistent elevations and participants whose first elevation may have been at the Final Visit). - At least 2 consecutive visits (includes only persistent elevations).|Baseline and Week 52|Safety analysis set.||percentage of participants|||Number
80784|NCT00996281|Primary|Percentage of Participants With at Least 1 Adverse Event|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality.|From Week 0 (Day 1) to Week 52.|Safety analysis set: All participants who received at least 1 dose of study medication.||percentage of participants|||Number
80818|NCT00996125|Secondary|Number of Subjects Reporting Pregnancies and Pregnancy Outcomes||Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
86396|NCT00943592|Primary|Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
80785|NCT00996216|Secondary|Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)|SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.|From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.||Participants|||Number
80786|NCT00996216|Primary|Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population||Participants|||Number
80787|NCT00996216|Primary|Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population||Participants|||Number
80788|NCT00996216|Primary|Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2|Visual acuity (VA) is defined as acuteness or clearness of vision.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population: all participants in the Pre-antiviral Safety Population||Participants|||Number
80789|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2|Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population||Participants|||Number
80790|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1|Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.||Participants|||Number
80791|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population||Participants|||Number
80792|NCT00996216|Primary|Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.||Participants|||Number
80793|NCT00996216|Primary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy||Participants|||Number
80830|NCT00995930|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Blood samples were collected to analyze hsCRP.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||mg/L||95% Confidence Interval|Geometric Mean
86397|NCT00943579|Secondary|Adverse Events Reporting||Cummulative throughout study||||||
80794|NCT00996216|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study||Participants|||Number
80795|NCT00996216|Secondary|Number of Particpants Who Initiated Antiviral Therapy|The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.|From the start of the investigational product up to 9 weeks (median of 21 days)|Pre-antiviral Safety Population||Participants|||Number
80796|NCT00996216|Secondary|Platelet Counts at the Indicated Time Points|Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Pre-antiviral Safety Population||Gi/L||Standard Deviation|Mean
80797|NCT00996203|Secondary|Erythrocyte Sedimentation Rate|ESR (mm/hr) is used to determine the acute phase response.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mm/hr||Standard Deviation|Mean
80798|NCT00996203|Secondary|C-Reactive Protein|CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mg/L||Standard Deviation|Mean
80799|NCT00996203|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of participants|||Number
80800|NCT00996203|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of participants|||Number
80801|NCT00996203|Secondary|Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||percentage of participants|||Number
80802|NCT00996203|Primary|Change in HAQ Score at Week 24|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline and Week 24|ITT population||units on a scale||Standard Deviation|Mean
80803|NCT00996203|Primary|Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|ITT population:||percentage of participants|||Number
80804|NCT00996203|Secondary|Change in DAS28 Score From Baseline to Week 24||Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
80805|NCT00996203|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||units on a scale||Standard Deviation|Mean
80806|NCT00996203|Secondary|Change in General Health Assessed by VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
80809|NCT00996203|Secondary|Change in EQ-5D Score at Week 24 From Baseline|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
80810|NCT00996203|Secondary|European Quality of Life - 5 Dimensions (EQ-5D) Score|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||units on a scale||Standard Deviation|Mean
80811|NCT00996203|Secondary|Pain Score as Assessed by Visual Analogue Scale (VAS)|Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.||mm||Standard Deviation|Mean
80812|NCT00996203|Primary|Health Assessment Questionnaire (HAQ) Score|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.|Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit|Intent-to-Treat (ITT) population: All participants randomized in the study who received administration of at least one dose of the study drug and who had at least one efficacy assessment performed. n (number) = number of participants assessed at a specific visit.||units on a scale||Standard Deviation|Mean
80813|NCT00996164|Primary|Change From Baseline in the SSE Count From Baseline to 24 Weeks|"The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).~Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.~An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry."|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.||SSEs||Standard Deviation|Mean
80814|NCT00996164|Primary|The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.|The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Mean
80815|NCT00996125|Primary|Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens|Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month after the third dose (at Month 7)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
80816|NCT00996125|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
80817|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 – 29) after any vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
80819|NCT00996125|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs)|"Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.~MSCs were collected regardless of causal relationship to vaccination and intensity."|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
80820|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0 – 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
80821|NCT00996125|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 7 days (Days 0 – 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
80822|NCT00996125|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.|At Month 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available.||Subjects|||Number
80823|NCT00996034|Primary|Mean of the Average Nicotine Binding % at Scan 1 and Scan 2|nAchR levels from baseline and after immunization with 3’-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3’-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.|3 months|||percentage of average nicotine binding||Standard Deviation|Mean
80824|NCT00995930|Secondary|Pharmacokinetics: ACZ885 Serum Concentrations|Blood samples were collected to analyze the ACZ885 serum concentrations.|pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12|Only participants from the PK analysis set, who had evaluable data at each time point, were included in the analysis for that time point. The PK analysis set included randomized participants from the ACZ885 arm who received at least one dose of study medication.||ng/mL||Standard Deviation|Mean
80825|NCT00995930|Secondary|Change From Baseline Insulin Resistance (HOMA-IR)|Blood samples were collected to analyze insulin resistance. Insulin resistance was calculated by the Homeostasis Model Assessments of insulin resistance (HOMA-IR)) as follows: HOMA-IR: The product of basal glucose (mmol/L) and insulin (µU/mL) levels divided by 22.5 [i.e., HOMA-IR = basal glucose*basal insulin/22.5].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||IR score||95% Confidence Interval|Geometric Mean
80826|NCT00995930|Secondary|Change From Baseline in Beta Cell Function (HOMA-B)|Blood samples were collected to analyze beta cell function. Beta cell function was calculated by the Homeostasis Model Assessments (of beta cell function (HOMA-B) as follows: HOMA-B: The product of 20 and basal insulin (µU/mL) levels divided by the value of basal glucose (mmol/L) concentrations minus 3.5 [i.e., HOMA-B = 20*basal insulin/(basal glucose-3.5)].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||percentage of beta cell function||95% Confidence Interval|Geometric Mean
80827|NCT00995930|Secondary|Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)|Blood samples were collected to analyze the 2 hour glucose post OGTT.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||mmol/L||95% Confidence Interval|Geometric Mean
80828|NCT00995930|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|Blood samples were collected to analyze HbA1c.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||percentage||95% Confidence Interval|Geometric Mean
80829|NCT00995930|Secondary|Change From Baseline in Fasting Plasma Glucose|Blood samples were collected to analyze fasting plasma glucose.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.||mmol/L||95% Confidence Interval|Geometric Mean
81024|NCT00993421|Secondary|Change in Glycated Hemoglobin A1c (HbA1c) From Baseline|Analysis of change in HbA1c was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to the small sample size.||percent glycated hemoglobin||Standard Deviation|Mean
80831|NCT00995930|Secondary|Change From Baseline in Aortic Strain|Arterial strain was computed directly from the cine SSFP images and the change in lumen diameters over the cardiac cycle. The value was independent of pulse pressure and is unitless ratio derived from the maximum to minimum lumen diameters diastole and systole, respectively..|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||ratio||Standard Error|Least Squares Mean
80832|NCT00995930|Secondary|Change From Baseline in Plaque Composition|During the carotid MRI acquisition, in addition to the PD weighted ECG gated double inversion fast spin echo sequences T1 and T2 weighted sequences were acquired. In combination with the PD weighted images, the multi-contrast images were analyzed to determine regions of interest with contrast patterns consistent with the presence of necrotic lipid core, calcification and fibrous tissue in participants who had complex carotid plaque present in the bifurcation region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||mm^2||Standard Deviation|Mean
80833|NCT00995930|Secondary|Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||ms^-1||Standard Error|Least Squares Mean
80834|NCT00995930|Primary|Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)|For assessment of atherosclerotic plaque burden of the aorta, vessel wall images of the aorta were acquired with an ECG gated double-inversion recovery (black blood) fast spin echo sequence applied breath-holding. Using an oblique sagittal image of the aorta as a pilot, serial axial images were acquired to cover a section of the descending thoracic aorta. The midpoint of the right pulmonary artery in cross section was used as the anatomical reference for the first slice in baseline and follow-up scans. For assessment of the atherosclerotic plaque burden in the carotids, vessel wall images were acquired with an axial ECG gated PD (proton density) weighted black blood sequence. The carotid bifurcation was used as the anatomical reference for all three imaging time points (baseline, 12 weeks, 48 weeks) with axial slice planes acquired below the bifurcation region. The mean values reported here for the carotid are reported for the proximal common carotid region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||mm^2||Standard Error|Least Squares Mean
80835|NCT00995930|Primary|Change From Baseline in Aortic Distensibility|Two axial, ECG-gated, steady state free precession (SSFP) ‘cine’ images were acquired during breath-hold to determine aortic distensibility. The first image was obtained at the level of the right pulmonary artery through the ascending and proximal descending aorta and the second through the distal aorta below the diaphragm. Imaging of the aorta also enabled evaluation of the plaque burden and additional vascular function measures.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.||mmHg^-1||Standard Error|Least Squares Mean
80836|NCT00995930|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|12 months|Safety analysis set: The safety analysis set included all randomized participants who received at least one dose of study drug.||Number of participants|||Number
80837|NCT00995904|Primary|Half-life (t1/2) of Budesonide After Administration of MAP0020|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|12 hours|Patients with available data at specified time points are included in the analysis population.||minutes||Standard Deviation|Mean
80838|NCT00995904|Primary|AUC(0-inf) of Budesonide After Administration of MAP0020|The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.||pg*min/ml||Standard Deviation|Mean
80839|NCT00995904|Primary|Cmax of Budesonide After Administration of MAP0020|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Mean
80840|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.~After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.~Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.~At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 22 up to 42 Days.|Subjects were to combined at days 22 to 42 . At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.||participants|||Number
80842|NCT00995865|Secondary|Percentage of Subjects With Seroconversions or Who Are Seropositive Using 2 Dose Levels of XRX-001|Secondary immunogenicity endpoints will use 2 dose levels of XRX-001 inactivated yellow fever vaccine determined by 50% plaque reduction neutralization test (PRNT50). Dose groups were to be compared for neutralizing antibody seroconverison rate, distribution of antibody titers, and geometric mean antibody titers (GMTs) to yellow fever 17D virus. The seroconversion rates and GMT neutralizing antibody titers for each dose group and all dose groups combined; The reverse cumulative distribution curve of antibody titers;|Days 21 and 42, 12 months|Seropositive was to show a significant level of serum antibodies, or other immunologic marker in the serum, indicating previous exposure to the infectious agent being tested. In immunology, seroconversion is the time period during which a specific antibody develops and becomes detectable in the blood.||Percentage of subjects||95% Confidence Interval|Number
80843|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.~After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.~Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.~At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 0 up to 21 Days|Subjects were to return to the clinic on Days 3,10, 21, 24, 31,and 42 with the second vaccination given on Day 21. At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.||participants|||Number
80844|NCT00995774|Secondary|A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).||pre-treatment, post treatment||||||
80845|NCT00995774|Secondary|Action Research Arm Test|This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2|||units on a scale||Standard Deviation|Mean
80846|NCT00995774|Primary|Fugl-Meyer Test of Motor Function|This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2|||units on a scale||Standard Deviation|Mean
80847|NCT00995761|Primary|We Conducted the Present Phase II Study to Investigate the Efficacy and Safety of a Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable NSCLC.|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC (OS, TTP, and Others)|after every 2 cycles of docetaxel and cisplatin||12/2012||||
80848|NCT00995761|Secondary|Time to Progression and Overall Survival Confirmed Through Follow-up and Observation Following Treatment||From date of enrollment in this study until the date of first documented progression or date of death from any cause, whichever came first, after every 2 cycles of docetaxel and cisplatin||||||
80849|NCT00995761|Primary|Response Rates Confirmed With CT or MRI|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0."|after every 2 cycles of docetaxel and cisplatin|The sample size was calculated according to Simon's two-stage optimal design.The statistical evaluation was performed based on an ITT analysis. Descriptive statistics are reported as proportions and medians. OS and TTP were assessed by the K-M method, and the 95% CI for the median time to events was computed.||percentage of participants||95% Confidence Interval|Number
80850|NCT00995722|Secondary|Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25||4 months|||units on a scale||95% Confidence Interval|Mean
80851|NCT00995722|Secondary|Change in Quality of Life as Measured by the MG-QOL-15 Score||4 Months|||units on a scale||95% Confidence Interval|Mean
80852|NCT00995722|Secondary|Change in Quality of Life as Measured by the NEI-VFQ-25 Measures||4 months|||units on a scale||95% Confidence Interval|Mean
80853|NCT00995722|Secondary|Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16||4 months|||units on a scale||95% Confidence Interval|Mean
80854|NCT00995722|Primary|Treatment Failure|Failure to achive sustatined minimal manifestation status by week 16|4 months|||percentage of participants||95% Confidence Interval|Number
80855|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment|Patients number of occurences during a 24 week period.|24 weeks|Full analysis set||Participants|||Number
80856|NCT00995709|Secondary|To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet’s Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet’s Disease Current Activity Form.|The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease.|baseline and wk 24 (end of study)|Full Analysis set||change from baseline score||Standard Deviation|Mean
80857|NCT00995709|Secondary|To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet’s Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.|The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function.|screening, and wk 24 (end of study)|Full Analysis Set||Score||Standard Deviation|Mean
80858|NCT00995709|Secondary|To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet’s Disease as Determined by Optical Coherence Tomography.|Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression.|baseline, and wk 24 (end of study)|(Full Analysis Set)||change from baseline : micrometers||Standard Deviation|Mean
80859|NCT00995709|Secondary|Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)|For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.|24 weeks|Full Analysis Set||immunosuppressive medication score||Standard Deviation|Mean
80860|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment||Baseline to week 24|Full Analysis Set||Ocular Exacerbations||Standard Deviation|Mean
80861|NCT00995670|Primary|Forearm Blood Flow|endothelial (forearm blood flow) responses to acetylcholine stimulation at baseline, and under conditions of high glucose before and after ischemia/reperfusion injury, and same with the addition of an intervention: sevoflurane (Arm 1), vitamin C (Arm 2), and high statin (Arm 3).|Baseline, Glucose Control, 15-min post ischemia|||ml/100 ml tissue/min||Standard Error|Mean
80862|NCT00995566|Primary|Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease|The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.|Baseline up to year 1|FAS||percentage of participants|||Number
80863|NCT00995566|Primary|Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results|Counts of participants who had bleeding events or treatment-emergent bleeding events, defined as newly occurring or worsening after first dose. Serious bleeding events reported from time of informed consent. Relatedness to Thelin assessed by investigator (Yes/No). ERA usage: was participant taking Vitamin K antagonist? (Yes/No). INR: participant's prothrombin time (PT) ratio. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS||participants|||Number
80864|NCT00995566|Primary|Concomitant Medications|Number of participants with concomitant medication usage reported by drug categories.|Baseline, monthly up to 1 year|Data not summarized due to the small number of participants in database.||participants|||Number
80865|NCT00995566|Primary|Clinical Status Since Last Visit|Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.||participants|||Number
80866|NCT00995566|Primary|Adverse Events (AEs) by Seriousness and Relationship to Treatment|Counts of participants who had AEs or treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Serious adverse events (SAEs) were reported from the time of informed consent. Relatedness to Thelin was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS||participants|||Number
80867|NCT00995566|Primary|Duration of Exposure to Thelin|Time between the first and last dose of Thelin. For participants who continued Thelin from TOPS (another study), the initial TOPS’ Thelin start date was used.|1 Year|FAS||months||Standard Deviation|Mean
80868|NCT00995566|Primary|Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline|Total and conjugated bilirubin levels measured from blood, but indirect bilirubin calculated. Indirect bilirubin=Total bilirubin - Conjugated bilirubin. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.||percentage of participants|||Number
80869|NCT00995566|Primary|Percentage of Participants With a Decrease in Hemoglobin Post-baseline|Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.||percentage of participants|||Number
80903|NCT00994760|Secondary|Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed')."||units on a scale||Standard Deviation|Mean
80870|NCT00995566|Primary|Percentage of Participants With Elevated Liver Function Post-baseline|Elevated liver function: greater than 3 times the upper limit of normal (>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Full Analysis Set (FAS): participants enrolled in Patient Registry of Sitaxentan in Europe (PROSE). Number of participants analyzed (N): participants with evaluable data.||percentage of participants|||Number
80871|NCT00995553|Secondary|Functional Capacity - University of California, San Diego Performance-Based Skills Assessment|The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.||units on a scale||Standard Deviation|Mean
80872|NCT00995553|Primary|Cognitive Assessment - MATRICS Consensus Cognitive Battery|The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.||T-score||Standard Deviation|Mean
80873|NCT00995488|Secondary|Median Overall Survival|The Median Overall Survival was captured in months.|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.||months||95% Confidence Interval|Median
80874|NCT00995488|Primary|Percentage of Participants With a Partial or Complete Response|"Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response [PR] + Complete Response[CR]) to therapy.~Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions.~Complete Response: Disappearance of all target lesions."|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.||percentage of participants||95% Confidence Interval|Number
80875|NCT00995449|Primary|This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.|KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)|Weeks 14 & 30|This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects.||Participants|||Number
80876|NCT00995436|Secondary|Patient Perception of the Different Treatment Methods, Including Surgical Experience||2 years||||||
80877|NCT00995436|Primary|Anchorage Loss Measured From 3-D Model Scanning||2 years|||mm||Standard Deviation|Mean
80878|NCT00995410|Secondary|Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation|Most Frequent (≥ 1%) Treatment Emergent Adverse Events by System Organ Class leading to Discontinuation|12 months|Overall Safety Population. Events were collected by systematic assessment. One subject reported two adverse events leading to discontinuation from the study. SOC from vocabulary, MedDRA (12.1).||participants|Participants||Number
80879|NCT00995410|Primary|Number of Subjects Monitored for Long-term Safety of PA32540|Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).|12 months|||participants|||Number
80880|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a ‘more limited’ life.~The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value"|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.||units on a scale||95% Confidence Interval|Mean
80881|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.||units on a scale||95% Confidence Interval|Mean
80882|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a ‘more limited’ life.~The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value"|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.||units on a scale||95% Confidence Interval|Mean
80919|NCT00994760|Primary|Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination|Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."||units on a scale||Standard Deviation|Mean
80883|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.||units on a scale||95% Confidence Interval|Mean
80884|NCT00995345|Secondary|Percentage of Patients Requiring Rescue Therapy for Elevated Glucose|Percentage of Subjects Requiring Rescue Therapy – Intent-to-Treat Population|24 weeks of treatment.|||% of subjects in group|||Number
80885|NCT00995345|Secondary|Percentage of Patients Achieving HbA1c Less Than 7%|Subjects Achieving Target of Hemoglobin A1c <7.0% at Week 24 with LOCF – Intent-to-Treat Population|24 weeks|||% of subjects in group|||Number
80886|NCT00995345|Secondary|Change in Body Weight|Mean Change in Body Weight (kg) from Baseline to Week 24 with LOCF- ITT|24 weeks|||kg body weight on scale||Standard Error|Least Squares Mean
80887|NCT00995345|Primary|Change in HbA1c From Baseline (Week 0) to Week 24|Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)|Week 24|Conducted analyses of ITT population of change in HbA1c from baseline (Week 0) to Week 24. If the Wk 24 measurement was missing, the last valid post-baseline observation (LOCF) algorithm was used to impute Week 24 value (1 on-treatment value required). Efficacy data collected after the initiation of rescue therapy was excluded from the analyses.||% HbA1c||95% Confidence Interval|Least Squares Mean
80888|NCT00995085|Primary|Safety and Tolerability|Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug|24 hours after drug adminstration|||events|||Number
80889|NCT00995020|Secondary|Time Spent to Perform the Procedure|Time was recorded from insertion until removal of the vaginal speculum.|Time spent from randomization to complete the procedure|||minuts||Standard Deviation|Mean
80890|NCT00995020|Primary|Endocervical Margin Not Free of Disease.|Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.|3 months after the surgery is performed.|All data were analysed bu intention to treat.||participants|||Number
80891|NCT00995007|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|70 months and 19 days|||participants|||Number
80892|NCT00995007|Secondary|Overall Survival|Time between the first day of treatment and the day of death.|Time between the first day of treatment and the day of death, up to 1.5 years|The group data is displayed per the report provided to the Food and Drug Administration.||Months||95% Confidence Interval|Median
80893|NCT00995007|Primary|Progression Free Survival at 6 Months|Percentage of participants who are alive and progression-free at 6 months.|6 months|The group data is displayed per the report provided to the Food and Drug Administration.||percentage of participants|||Number
80894|NCT00994929|Secondary|The Mechanism of Study Drug Effect by VWF mRNA.||within 11 days of study drug.|||fold increase||Full Range|Mean
80895|NCT00994929|Secondary|The Frequency of Adverse Events||within 11 days of study drug|||participants|||Number
80896|NCT00994929|Primary|Biologic Effects by Coagulation Tests|VWF activity was measured by ristocetin-induced platelet agglutination using a Chronolog aggregometer11-14 and VWF:Ag by “sandwich” ELISA, using anti-VWF antibodies (DakoA082, Carpintera CA). Results were expressed in percent, with normal human plasma pool designated 100%, and severe type 3 VWD plasma used as the negative control|within 4 days of study drug.|Four subjects had VWD and five subjects had mild hemophilia A||percentage of normal||Standard Error|Mean
80897|NCT00994760|Secondary|Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...|Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more|after therapy with Instanyl (last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed'). N= number of valid cases"||units on a scale||Standard Deviation|Mean
80898|NCT00994760|Secondary|Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed') =N."||units on a scale||Standard Deviation|Mean
80899|NCT00994760|Secondary|Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|after therapy with Instanyl (first/last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat.~All patients with valid values ('as observed'). N= number of valid cases."||units on a scale||Standard Deviation|Mean
80900|NCT00994760|Secondary|Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
80901|NCT00994760|Secondary|Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
80920|NCT00994760|Primary|Dose of Instanyl|Initially prescribed dose/ most efficient single dose of Instanyl at study end|during therapy with Instanyl (planned: 28 days)|"Patients included and treated (without imputation of missing values), intention to treat.~All patients included"||participants|||Number
80904|NCT00994760|Secondary|Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
80905|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5|conspicuous score <1.5 inconspicuous score ≥1.5|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."||participants|||Number
80906|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)|Scale: 0=worst, 5=best|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=93~Last Visit N=81"||units on a scale||Standard Deviation|Mean
80907|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20|"0= conspicuous ≤20~1= inconspicuous >20"|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."||participants|||Number
80908|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)|Scale: 0=complete impairment, 43=no impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=93~Last Visit N=82"||units on a scale||Standard Deviation|Mean
80909|NCT00994760|Secondary|Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)|Scale: 0=no impairment, 70=complete impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=92~Last Visit N= 80"||units on a scale||Standard Deviation|Mean
80910|NCT00994760|Secondary|Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?|Scale: 0=not at all, 10=completely|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=94~Last Visit N=83"||units on a scale||Standard Deviation|Mean
80911|NCT00994760|Secondary|Patient: How do You Feel Today?|Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=94~Last Visit N=83"||units on a scale||Standard Deviation|Mean
80912|NCT00994760|Secondary|Patient: Description of Pain at Initial Visit|0=no pain, 10= most intense pain imaginable|initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed') =N."||units on a scale||Standard Deviation|Mean
80913|NCT00994760|Secondary|Patient: How Many Episodes of Pain You Experience on Average?||initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit."||episodes per day||Standard Deviation|Mean
80914|NCT00994760|Primary|Physician: What is the Current Treatment Needs of Your Patient Regarding ...|Scale: 0=no, 1=low, 2=medium, 3=high|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."||units on a scale||Standard Deviation|Mean
80915|NCT00994760|Primary|Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N=number of valid cases."||units on a scale||Standard Deviation|Mean
80916|NCT00994760|Primary|Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)|5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
80917|NCT00994760|Primary|Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed')= N."||units on a scale||Standard Deviation|Mean
80918|NCT00994760|Secondary|Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit."||units on a scale||Standard Deviation|Mean
80921|NCT00994604|Secondary|Changes in Airway Size by Computed Tomography|Changes in size airways as measured by computed tomography|baseline and after two weeks|||size in mm^2||Standard Deviation|Mean
80922|NCT00994604|Primary|The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract|"Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100~Bronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100"|baseline and two weeks|||index||Standard Deviation|Mean
80923|NCT00994461|Secondary|Incidence of Treatment-emergent, All-causality GI Body System Adverse Events|The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
80924|NCT00994461|Secondary|Number of Gastroduodenal Erosions in Each Subject|Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Participants|||Number
80925|NCT00994461|Secondary|Number of Gastroduodenal Ulcers in Each Subject|Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Participants|||Number
80926|NCT00994461|Secondary|Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)|Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Participants|||Number
80927|NCT00994461|Secondary|Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions|The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
80928|NCT00994461|Secondary|Incidence of Any Gastric, and Duodenal Ulcers|The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
80929|NCT00994461|Primary|Incidence of Gastroduodenal Ulcers|The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.||Percent|||Number
80930|NCT00994448|Primary|Feasibility of Retaining Adolescents in Trial|the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)|8 weeks|mean days retained in treatment for each grou[p||days||Standard Deviation|Mean
80931|NCT00994422|Primary|Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator.~Severe scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - Large areas of the scalp are red; Severe Excoriation: Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Local tolerability was assessed in the Intent-to-treat (Safety) population.||Participants|||Number
80932|NCT00994422|Primary|Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)||Day 1 up to Day 28 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population.||Participants|||Number
80933|NCT00994422|Primary|Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.|Days 2 up to Day 15 post-treatment|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of Participants|||Number
80966|NCT00993668|Secondary|Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 216 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80934|NCT00994318|Primary|Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger|"Endpoint reported number of participants with/without events and was reached:~First time of initiation of additional or alternative anaemia management,~First time the subject reached the Hb trigger.~3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:~FCM (high ferritin target) compared with oral iron.~FCM (high ferritin target) compared with FCM (low ferritin target).~FCM (low ferritin target) compared with oral iron.~Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:~Without taking into account the Hb trigger.~Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory."|Up to 1 year after baseline|The Full Analysis Set (FAS) was used for the primary endpoint analysis, which consisted of all subjects randomised to treatment, received at least 1 dose of study treatment or, according to the protocol, were not treated due to ferritin value <100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment available.||participants|||Number
80935|NCT00994253|Secondary|Secondary Measures Include Evaluation of Serum and Urine Biomarkers Related to Endothelial Function, the Renin-angiotensin System, Oxidative Stress, and Inflammation.|Biomarkers include asymmetric dimethylarginine, B-type natriuretic peptide, plasma renin activity, high-sensitivity C-reactive protein, adiponectin, aldosterone, angiotensinogen, and hemoglobin A1c.|6 months||||||
80936|NCT00994253|Primary|The Primary Objective is to Assess the Effect of a Multimodal Drug Therapy Regimen Including the Renin Inhibitor Tekturna (Aliskiren), an ACE Inhibitor, and a Calcium Channel Blocker on Coronary Flow Reserve (CFR) in Hypertensive Type II Diabetics.|The primary objective is to assess the effect of a multimodal drug therapy regimen including the renin inhibitor Tekturna (aliskiren), an ACE inhibitor, and a calcium channel blocker on coronary flow reserve (CFR) in hypertensive Type II diabetics. The CFR will be assessed by a PET-based imaging technique.|6 months||||||
80937|NCT00994240|Primary|Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.|Clinical evidence of BCC recurrence post treatment|base line, every 3 months until 12 month completion|Study was terminated early due to lack of funding and slow enrollment. Biostatisticians determined insufficient data was available for statistical significance. Primary/lead protocol author is no longer at the institution and no data analysis is intended. Study has been closed with the local IRB and study files archived.||participants|||Number
80938|NCT00994214|Secondary|Number of Subjects Reported Adverse Events During the Study|"For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen.~TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study."|Up to Visit 10 (An average of 6.5 Months)|"Safety Population~Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received."||Participants|||Number
80939|NCT00994214|Secondary|Percentage Change in Ring Finger Circumference|Percentage change from Baseline at month X = (Ring finger circumference at month X – ring finger circumference at baseline) x 100 / ring finger circumference at baseline.|Baseline (Day 1) and Month 6|ITT population. N=Number of subjects attended Month 6 (visit 9).||Percentage of Change in Ring Finger circ||Standard Deviation|Mean
80940|NCT00994214|Secondary|Changes in IGF-1||Baseline (Day 1) and Month 6|ITT population||Percentage of ULN||Standard Deviation|Mean
80941|NCT00994214|Secondary|Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6|Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline|0-3 hr on Baseline (Day 1) and Months 1, 3 and 6|N=Number of patients randomised to treatment in IGF-1 <2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum.||Percentage of change in mean GH||Standard Deviation|Mean
80942|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 1|ITT population. N=Number of subjects attended Month 1 (visit 5).||Percentage of subjects|||Number
80943|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 3|ITT population. N=Number of subjects attended Month 3 (visit 7).||Percentage of subjects|||Number
80944|NCT00994214|Primary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 6|Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9).||Percentage of subjects|||Number
80945|NCT00994123|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Erlotinib in Formalin Fixed (FFPE) Tumor Samples|Tumor tissue samples were obtained from patients prior to enrollment. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to erlotinib can increase PFS in HRG-high patients.|Time from first dose to date of progression, with a median of 8.1 weeks|Patients with available tissue for heregulin testing||months PFS||95% Confidence Interval|Median
80946|NCT00994123|Primary|Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination|"This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, with a median of 8.1 weeks|||weeks||95% Confidence Interval|Median
81022|NCT00993421|Secondary|Change in Fasting Insulin From Baseline to 24 Weeks Endpoint|Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.||micro Units/milliliter (μU/mL)||Standard Deviation|Mean
80947|NCT00994123|Primary|Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|"Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs.~The determined MTD was used as the recommended Phase 2 dose."|From date of first dose to 30 days after termination, the longest 175 weeks|All participants treated in the Phase 1 dose-escalation portion of the study||dose level of MTD|||Number
80948|NCT00994123|Primary|Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.|To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 175 weeks|||participants reporting DLTs|||Number
80949|NCT00994110|Primary|To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo.||60 days|||percentage of participants|||Number
80950|NCT00993954|Secondary|Proportion of Patients With RHS Not Identified by Nurse Pathway.||End of enrollment|||participants|||Number
80951|NCT00993954|Secondary|Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture.||Every 3 months during enrollment|||participants|||Number
80952|NCT00993954|Secondary|Time to Discharge From ED (Minutes)||End of enrollment|2 missing data point in the physician group||minutes||Full Range|Median
80953|NCT00993954|Primary|Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls||10-15 minutes post reduction attempt|||percentage of patients reduced|||Number
80954|NCT00993915|Other Pre-specified|Percent Change From Baseline in Lipid Parameters at 1 Month|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.|||||
80955|NCT00993915|Other Pre-specified|Change From Baseline in Lipid Parameters at 1 Month|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.|||||
80956|NCT00993915|Secondary|Percent Change From Baseline in Lipid Parameters|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 6|FAS population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Percent change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.||percent change||95% Confidence Interval|Mean
80957|NCT00993915|Secondary|Change From Baseline in Lipid Parameters|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 6|FAS Population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.||mg/dL||95% Confidence Interval|Mean
80958|NCT00993915|Secondary|Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit||Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified for this outcome measure.|||||
80959|NCT00993915|Primary|Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit||Month 6|Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data.||percentage of participants||95% Confidence Interval|Number
80960|NCT00993824|Primary|Hypoglycemia Percentage of Time <70 mg/dL Average by Group|Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||percentage of time <70 mg/dL||Standard Deviation|Mean
80961|NCT00993824|Primary|Wake Norm AUC Average by Group (Normalized)|Wake glucose captured by continuous glucose monitoring (CGM).|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||mg/(dL/hr) (normalized)||Standard Deviation|Mean
80962|NCT00993824|Primary|Sleep Norm AUC Average by Group (Normalized)|Overnight glucose captured by CGM.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||mg/(dL/hr) normalized||Standard Deviation|Mean
80963|NCT00993824|Primary|Total Norm AUC Average by Group (Normalized)|Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|||mg/(dL/hr) normalized||Standard Deviation|Mean
80964|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80965|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80968|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||Baseline, End of single blind period (week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers but with protective influenza antibody titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80969|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 180 were in the Per Protocol Set Pneumococcal (PPSP) population (90 Placebo, 90 CZP) without baseline protective titers. Of these 180 subjects 150 (75 Placebo, 75 CZP) had protective pneumococcal antibody titers and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80970|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 109 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80971|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80972|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80973|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.||percentage of participants||95% Confidence Interval|Number
80974|NCT00993616|Primary|Duration of Progression-free Interval for All Patients||Up to 5 years||||||
80975|NCT00993616|Primary|Survival Time for All Patients||Up to 5 years||||||
80976|NCT00993616|Primary|Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 4.0||Up to 5 years||||||
80977|NCT00993616|Primary|Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1)|Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (version 1.1): Complete Response (CR) is disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Increasing Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest|From study entry, up to 5 years|||participants|||Number
80978|NCT00993499|Secondary|Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin|Evaluation of laboratory parameters included assessment of the frequency of patients with ALT and AST elevations concurrent with elevated bilirubin and indicative of Hy’s law cases.|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
80979|NCT00993499|Secondary|Percentage of Patients With Drug-related AEs|Percentage of patients with drug-related adverse events (AEs).|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
80980|NCT00993499|Secondary|Occurrence of Adverse Events According to CTCAE, Version 3.0|Percentage of participants with adverse events according to highest Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
80981|NCT00993499|Secondary|AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of sirolimus at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80982|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)|Maximum measured plasma concentration of sirolimus at steady state (Cmax,ss)|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80983|NCT00993499|Secondary|AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of Afatinib at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
80984|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)|Maximum measured plasma concentration of Afatinib at steady state (Cmax,ss)|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
80985|NCT00993499|Secondary|Exploratory Examination of EGFR Mutations (Exons 19, 20 and 21 and Others) in Serum/Plasma DNA and Tumour DNA.|"Exploratory examination of Epidermal growth factor (receptor)(EGFR) mutations (Exons 19, 20 and 21 and others) in serum/plasma DNA and tumour DNA.~This endpoint was not analysed in the study report as the available data was too limited."|Multiple time points during the trial|Treated set. This endpoint was not analysed in the study report as the available data was too limited.|||||
80986|NCT00993499|Secondary|Rate of Disease Control|Rate of (unconfirmed) disease control defined as CR, PR, or stable disease (SD), according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
80987|NCT00993499|Secondary|Objective Response|Rate of (unconfirmed) objective response, defined as complete response (CR) or partial response (PR) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
80988|NCT00993499|Secondary|Best Overall Response|Best overall response (unconfirmed) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set||Percentage of participants|||Number
80989|NCT00993499|Primary|Occurrence of Dose Limiting Toxicities (DLT)|Number of participants with of dose limiting toxicities (DLT)|2 first cycles, 56 days|Treated set||Participants|||Number
80990|NCT00993473|Other Pre-specified|Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded during the nocturnal time period (between 23:00 and 07:00 hours).|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).||mmol/L||Standard Deviation|Mean
80991|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low FSBG (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low FSBG consisted of all low FSBG readings (values <70 mg/dL) performed at other times."|6 months|Same as for primary endpoint: mITT population.||events per patient-year||Standard Deviation|Mean
80992|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low CGMS Excursions (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low CGMS excursions consisted of all low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL."|6 months|Same as for primary endpoint: mITT population.||events per patient-year||Standard Deviation|Mean
80993|NCT00993473|Other Pre-specified|Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded over all CGMS placements.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).||mmol/L||Standard Deviation|Mean
80994|NCT00993473|Other Pre-specified|Percent of Blood Glucose (BG) Within the Range of 70 – 180 mg/dL (3.9-10 mmol/L)|Calculated for each patient as the percent of all on-treatment CGMS values falling within the range of 70 – 180 mg/dL (3.9 – 10 mmol/L) inclusive.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).||percent of CGMS values within the range||Standard Deviation|Mean
80995|NCT00993473|Other Pre-specified|Number of Patients With Different Types of Hypoglycemia Events|Definitions of the different types of hypoglycemia events provided in the outcome measure description of the corresponding event rates.|6 months|Same as for primary endpoint: mITT population.||participants|||Number
80996|NCT00993473|Secondary|Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However 1 patient in the NPH group did not have baseline CGM value and 2 other patients (1 in the Lantus group and 1 in the NPH group) did not have on-treatment CGM values.||mmol/L||Standard Deviation|Mean
80997|NCT00993473|Secondary|Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit|Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with post-baseline HbA1c values. 2 patients from the Lantus group and 7 from the NPH group had no post-baseline HbA1c value.||percentage of participants|||Number
80998|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)|Assessed using an analysis of covariance (ANCOVA) model with treatment, and randomization strata (baseline number of CGM hypoglycemic excursions <0.5 events/24hours or ≥0.5 events/24 hours, and baseline HbA1c <8.5% or ≥8.5%) as fixed effects, and using the baseline value as covariate.|baseline, 6 months|Same as for primary endpoint: mITT population.||percent HbA1c||Standard Error|Least Squares Mean
80999|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However post-baseline HbA1c values were missing for 9 patients: 2 patients in the Lantus group and 7 in the NPH group.||percent HbA1c||Standard Deviation|Mean
83701|NCT00968617|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events||16 Weeks|||Participants|||Number
81000|NCT00993473|Secondary|Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year|Participants|Standard Deviation|Mean
81001|NCT00993473|Secondary|Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year||Standard Deviation|Mean
81002|NCT00993473|Secondary|"Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of All Hypoglycemia Episodes Divided by the Total Duration of the On-treatment Period in Years"|Nocturnal hypoglycemia: any event from the “all hypoglycemia” total that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year||Standard Deviation|Mean
81003|NCT00993473|Secondary|Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe.|6 months|Same as for primary endpoint: mITT population.||number of events per patient-year|Participants|Standard Deviation|Mean
81004|NCT00993473|Secondary|Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)|Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries.|6 months|Same as for primary endpoint: mITT population.||events per patient-year||Standard Deviation|Mean
81005|NCT00993473|Primary|"Event Rate of All Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"The rate of all hypoglycemia was calculated from all hypoglycemia episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL, - low FSBG readings (values <70 mg/dL) performed at other times."|6 months|The efficacy population consisted of all randomized patients who received at least one dose of the study medication (modified intent-to-treat [mITT] population). For efficacy analyses, patients were analyzed in the treatment group allocated by the Interactive Voice Response System (IVRS) at randomization (as randomized).||number of events per patient-year||Standard Deviation|Mean
81006|NCT00993447|Primary|Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited Systemic Reactions: Fever, ≥ 39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post-each vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
81007|NCT00993447|Primary|Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|"Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).~Flavivirus-naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain."|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
81008|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with < 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
81009|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (pre each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
83702|NCT00968617|Primary|Change From Baseline in Hemoglobin Level at Week 4||4 weeks|||g/dL||Standard Deviation|Mean
81010|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
81011|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
81012|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
81013|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.||Percentage of participants|||Number
81014|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.||Percentage of participants|||Number
81015|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.||Percentage of participants|||Number
81016|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Percentage of participants|||Number
81017|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.||Percentage of Participants|||Number
81018|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.||Percentage of participants|||Number
81019|NCT00993421|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|Analysis of Cmax was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed due to the small sample size.||nanograms per milliliter (ng/mL)||Standard Error|Geometric Mean
81020|NCT00993421|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC)|Analysis of AUC was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed because of the low sample size.||nanograms*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
81021|NCT00993421|Secondary|Change in Insulin Resistance From Baseline to 24 Weeks Endpoint|Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to inadequate number of samples.||Units of Insulin/Day||Standard Deviation|Mean
81025|NCT00993421|Secondary|Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale|Vitality change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body mass index was used as covariate. SF-36 is a self-reported questionnaire that consists of 36 questions covering 8 health domains including vitality. The vitality domain results are presented. The vitality domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||units on a scale||Standard Error|Least Squares Mean
81026|NCT00993421|Secondary|Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)|Results presented as Least Squares Mean with treatment, visit, and their interaction as fixed effects, subject as random effect, baseline body mass index used as covariate. OWL-QoL consists of 17 items on scale ranging from 0 (Not at all) to 6 (A very great deal). Before calculating scores, each item is reversed. A single quality of life score is computed by summing each item and transforming this raw score onto standardized scale of 0 (greatest impact) to 100 (lowest impact) using formula: score = [(sum of component items score (minus) lowest possible score/ possible raw score range)*100].|Baseline, 24 weeks|ITT||units on a scale||Standard Error|Least Squares Mean
81027|NCT00993421|Secondary|Change in Triglycerides From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
81028|NCT00993421|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
81029|NCT00993421|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
81030|NCT00993421|Secondary|Change in Total Cholesterol From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).||millimole/Liter (mmol/L)||Standard Deviation|Mean
81031|NCT00993421|Secondary|Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint|Percentage change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT||percent change||Standard Deviation|Least Squares Mean
81032|NCT00993421|Secondary|Change in Waist Circumference From Baseline to 24 Week Endpoint|Change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||centimeter (cm)||Standard Error|Least Squares Mean
81033|NCT00993421|Secondary|Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint|Change in body composition (lean body mass and fat mass) was assessed using dual energy x-ray absorptiometry (DXA) and is presented as LSMEAN values with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body composition, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||kilograms (kg)||Standard Error|Least Squares Mean
81034|NCT00993421|Secondary|Change in Blood Pressure From Baseline to 24 Week Endpoint|Blood pressure change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline blood pressure, age, gender were used as covariates.|Baseline, 24 weeks|ITT||mm Hg||Standard Error|Least Squares Mean
81035|NCT00993421|Secondary|Change in Heart Rate From Baseline to 24 Week Endpoint|Heart rate change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline heart rate, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||beats per minute (bpm)||Standard Error|Least Squares Mean
81036|NCT00993421|Secondary|Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks||24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||percentage of participants|||Number
81037|NCT00993421|Secondary|The Mean Change in Body Weight From Baseline to 24 Week Endpoint|Body weight change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||kilograms||Standard Error|Least Squares Mean
81055|NCT00993265|Primary|Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12|||units on a scale||Standard Error|Mean
81038|NCT00993421|Primary|Percent Change in Body Weight From Baseline to 24 Week Endpoint|Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.||percent change||Standard Error|Least Squares Mean
81039|NCT00993317|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.|Baseline and Week 24|FAS population||scores on a scale||Standard Deviation|Mean
81040|NCT00993317|Secondary|ACR70 Responses at Week24||Week 24|FAS population||participants|||Number
81041|NCT00993317|Secondary|ACR50 Responses at Week 24||Week 24|FAS population||participants|||Number
81042|NCT00993317|Secondary|ACR70 Responses at Week 12|Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week12|FAS population||participants|||Number
81043|NCT00993317|Secondary|ACR50 Responses at Week 12|Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population||participants|||Number
81044|NCT00993317|Secondary|ACR 20 Responses at Week 12|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population||participants|||Number
81045|NCT00993317|Primary|ACR20 Responses at Week 24|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 24|Full Analysis Set (FAS) Population The full set population will consist of all the subjects who were randomized and treated with the drug and received the primary efficacy evaluation at baseline. In the case of dosing administration error, analyses on the FAS population will be conducted according to the drug the subjects were randomized to.||participants|||Number
81046|NCT00993291|Secondary|Time to Walk 14 Meters|Change in the time to walk 14 meters compared to baseline measured in seconds|5 hours||||||
81047|NCT00993291|Secondary|Gait Velocity|gait velocity measured as change from baseline in in CM/second|5 hours||||||
81048|NCT00993291|Primary|Change in Stride Length From Baseline|Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length|1 hour|||CM||Full Range|Mean
81049|NCT00993265|Secondary|National Institute of Mental Health –Trichotillomania Severity Scale (NIMH-TSS)|The National Institute of Mental Health - Trichotillomania Severity Scale (NIMH-TSS) assesses severity of hair pulling. The NIMH-TSS is a 6 item assessment, with total scores ranging from 0-20. Higher scores indicate greater severity/impairment.|Week 12|||units on a scale||Standard Error|Mean
81050|NCT00993265|Secondary|The Milwaukee Inventory for Styles of Trichotillomania–Child Version|"The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses focused pulling, hair pulling that occurs intentionally to relieve tension or distress, and automatic pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the focused pulling subscale and 4 questions in the automatic pulling subscale. The scores range from 0-36 on the automatic pulling subscale and 0-189 on the focused pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style."|Week 12|||units on a scale||Standard Error|Mean
81051|NCT00993265|Secondary|Trichotillomania Scale for Children - Parent Version|The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12|||units on a scale||Standard Error|Mean
81052|NCT00993265|Secondary|Children's Depression Inventory|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12|||units on a scale||Standard Error|Mean
81053|NCT00993265|Secondary|Multidimensional Anxiety Scale for Children (MASC)|The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety.|Week 12|||units on a scale||Standard Error|Mean
81054|NCT00993265|Secondary|Trichotillomania Scale for Children - Child Version|The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12|||units on a scale||Standard Error|Mean
81056|NCT00993200|Secondary|Thrombotic Complication|Number of thrombotic events|12 week|||number of thrombotic events|||Number
81057|NCT00993200|Secondary|Adverse Major and Minor Bleeding Events|Number of major and minor bleeding events|12 week|||number of bleeding events|||Number
81058|NCT00993200|Primary|The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range|The number of days to first International Normalized Ratio (INR) is being measured from initiation of warfarin to the time when a subject first has an INR lab test result within +/- 0.5 of mean target INR range. The period during which this time interval could be measured is any time during the subject's warfarin therapy.|variable as defined|analysis per protocol||days||Standard Deviation|Median
81059|NCT00993187|Secondary|Percentage of Participants With HbA1C < 7.0% at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).|Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.||Percentage of Participants|||Number
81060|NCT00993187|Secondary|Change From Baseline in Body Weight at Week 30|Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)|Baseline and Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.||kg||95% Confidence Interval|Least Squares Mean
81061|NCT00993187|Secondary|Percentage of Participants With One or More Episodes of Hypoglycemia|Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.|Up to Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.||Percentage of participants|||Number
81062|NCT00993187|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).|Baseline and Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
81063|NCT00993187|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 30 weeks|The APaT Population includes all randomized participants who received at least 1 dose of study medication.||Participants|||Number
81064|NCT00993187|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 32 weeks|The All Patients as Treated (APaT) Population includes all randomized participants who received at least 1 dose of study medication.||Participants|||Number
81065|NCT00993187|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).|Baseline and Week 30|Full-Analysis-Set (FAS) Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
81066|NCT00993148|Secondary|Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL|Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|96 weeks|||percentage of participants||95% Confidence Interval|Number
81067|NCT00993148|Secondary|Median CD4 Count Change From Baseline|Median changes from baseline in peripheral CD4+ T-cell count|96 weeks|||cells per mm^3||Inter-Quartile Range|Median
81068|NCT00993148|Secondary|Trough Concentrations (Ctrough) of Maraviroc|Average trough concentration (Ctrough) of maraviroc|24 hours|||ng/mL||Standard Deviation|Mean
81069|NCT00993148|Secondary|Drug Adherence, Number of Participants With Missed Doses|Drug adherence, assessed as number of participants with missed doses over four-day recall|Week 24|||participants|||Number
81070|NCT00993148|Secondary|Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES||At study entry and at the time of virologic failure|||participants|||Number
81071|NCT00993148|Secondary|Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher|Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen|96 weeks|||participants|||Number
81072|NCT00993148|Secondary|Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL|Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|48 weeks|||percentage of participants||95% Confidence Interval|Number
81073|NCT00993148|Secondary|Percentage of Participants With Virologic Failure or Off Study Treatment Regimen|Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)|24 weeks|||percentage of participants||95% Confidence Interval|Number
81074|NCT00993148|Primary|Percentage of Participants With Plasma HIV-1 RNA >50|Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL|24 weeks|||percentage of participants||95% Confidence Interval|Number
81075|NCT00993044|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity events|2 years|||participants|||Number
81076|NCT00992992|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment to the date of death from any cause.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Months||95% Confidence Interval|Median
81077|NCT00992992|Secondary|Number of Participants With an Adverse Event of Cytopenia|The effects of iodine I-131 tositumomab on the growth and function of hematopoietic progenitor cells was measured as the number of participants who had cytopenia. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Participants|||Number
83741|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 12 months|||participants|||Number
81078|NCT00992992|Secondary|Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured. Conversion to HAMA positivity is relative to Screening (participants were evaluable for HAMA analysis if they were HAMA negative at Screening).|Screening; at Week 7, Week 13, then every 6 months until disease progression or death (up to 143 months)|ITT-Exposed Population. Only those participants evaluable for HAMA were analyzed.||Participants|||Number
81079|NCT00992992|Secondary|Time to Recovery From the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to recovery to Baseline for the indicated hematologic parameters is defined as the time required for recovery from nadir values to Baseline values.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.||Days||95% Confidence Interval|Median
81080|NCT00992992|Secondary|Time to Nadir for the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to nadir is defined as the time from Baseline to the time the lowest value recorded following the therapeutic dose.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.||Days||Standard Deviation|Mean
81081|NCT00992992|Secondary|Mean Nadir Values for Platelets and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had platelet and WBC data available.||1000 cells/microliter||Standard Deviation|Mean
81082|NCT00992992|Secondary|Mean Nadir Value for Hemoglobin|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had hemoglobin data available.||grams/deciliter (g/dL)||Standard Deviation|Mean
81083|NCT00992992|Secondary|Mean Nadir Value for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights infection.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had ANC data available.||1000 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
81084|NCT00992992|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Participants|||Number
81085|NCT00992992|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, alternative therapy, or death.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Months||95% Confidence Interval|Median
81086|NCT00992992|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment (i.e., the dosimetric dose) to the first documented disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must have been greater than 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population||Months||95% Confidence Interval|Median
81087|NCT00992992|Secondary|Duration of Response for Confirmed Complete Responders|Complete response is the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with confirmed CR were analyzed.||Months||95% Confidence Interval|Median
81088|NCT00992992|Secondary|Duration of Response for Unconfirmed Complete Responders|Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with unconfirmed CR were analyzed.||Months||95% Confidence Interval|Median
81098|NCT00992836|Secondary|Geometric Mean Antibody Titers (GMT) HAI|Presents the value of the geometric mean titer at each time point.|Measured after first and second doses and 6 months after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.||titers||95% Confidence Interval|Geometric Mean
81099|NCT00992836|Secondary|Percent of Participants With an HAI Titer >=40 at Long-term Follow-up||Measured at 6 months after second dose|The HAI titers were summarized for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.||percentage of participants||95% Confidence Interval|Number
81089|NCT00992992|Secondary|Duration of Response for All Unconfirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defind as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with an unconfirmed response (CR, CRu, or PR) were analyzed for duration of response.||Months||95% Confidence Interval|Median
81090|NCT00992992|Secondary|Duration of Response for All Confirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed (CRu) is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. For participants with CR, CRu, or PR, duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants (par.) with a confirmed CR, CRu, or PR were analyzed. The number of par. analyzed represents the par. with a confimed CR, CRu, or PR who also had the same response or a better response as confirmation (for example, a par. with an initial CRu and a subsequent CR has been included in the analysis).||Months||95% Confidence Interval|Median
81091|NCT00992992|Secondary|Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)|A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Participants with a confirmed response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). The individual rows for confirmed CR, confirmed CRu, and confirmed PR represent confirmation of the same response. For example, a confirmed CR indicates that a CR was followed by another CR at least 4 weeks later.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants evaluable for response (those with at least one response assessment) were analyzed.||Participants|||Number
81092|NCT00992992|Primary|Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)|Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 centimeters [cm] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population: all participants who received any iodine I-131 tositumomab or CHOP treatment. Only those participants evaluable for response (those with at least one response assessment) were analyzed.||Participants|||Number
81093|NCT00992927|Secondary|Pain Measured by Visual Analogue Scale (VAS)|"before intervention for all participants~using 10cm horizontal visual analog scale~best: 0cm (no pain)~worst: 10cm (worst pain)"|1 month|||cm||Standard Deviation|Mean
81094|NCT00992927|Primary|Range of Motion (ROM) of the Glenohumeral Joint|"before intervention for all participants~using a goniometer~patient sitting on a stool with the arm at anatomical position~worst: 0 degree~best: 360 degree"|1 month|||degree||Standard Deviation|Mean
81095|NCT00992836|Secondary|Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens|"The TIV assay was not performed due to lack of available cells after completion of other planned assays.~The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10^6 peripheral blood mononucleated cell (PBMC).~The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10^6 PBMC.~The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10^6 PBMC."|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||SFC/10^6 PBMC||Inter-Quartile Range|Median
81096|NCT00992836|Secondary|HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||titer||Inter-Quartile Range|Median
81097|NCT00992836|Secondary|Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 peripheral blood mononucleated cell (PBMC) and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
83742|NCT00968019|Secondary|Major Bleeding||Up to 12 months|||participants|||Number
81100|NCT00992836|Primary|Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640 and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and 10 days after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.||percentage of participants||95% Confidence Interval|Number
81101|NCT00992836|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|The 154 study participants who received at last one vaccination are included in this analysis.||participants|||Number
81102|NCT00992836|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 7 months after vaccination|The 154 study participants who received at last one vaccination are included in this analysis.||participants|||Number
81103|NCT00992836|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|"Shows the number of participants who had at least one adverse event (AE) in each category. The AEs include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs.~Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death."|Measured up to 7 months after vaccination|||participants|||Number
81104|NCT00992784|Secondary|The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180|The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 180 in subjects for whom data concerning immunogenicity were available for at least one test, 180 Days after vaccination.||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
81105|NCT00992784|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 21 in subjects for whom data concerning immunogenicity were available for at least one test, 21Days after vaccination.||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
81106|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||subjects|||Number
81107|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||subjects|||Number
81108|NCT00992784|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||fold increase||95% Confidence Interval|Geometric Mean
81109|NCT00992784|Secondary|HI Antibody Seroconversion Factors (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||fold increase||95% Confidence Interval|Geometric Mean
81110|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||subjects|||Number
81111|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||subjects|||Number
81112|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||subjects|||Number
81113|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||subjects|||Number
81114|NCT00992784|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.||titer||95% Confidence Interval|Geometric Mean
81115|NCT00992784|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.||titer||95% Confidence Interval|Geometric Mean
81116|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|After Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
81117|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Up to Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
81118|NCT00992784|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
81119|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
81120|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
81121|NCT00992784|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Days||Full Range|Median
81122|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
81123|NCT00992784|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.||Days||Full Range|Median
81124|NCT00992784|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
81125|NCT00992719|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to and at Day 21 post vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 21 following vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||participants|||Number
81145|NCT00992459|Secondary|Cmax PAGN of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg/mL||Standard Deviation|Mean
81272|NCT00991809|Primary|Change in Pain Tolerance (Time to Hand Removal in Seconds) in the Cold Pressor Test (Mean) at the 30 Minute Time Point||8 sessions over 4-6 weeks|One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.||seconds||Full Range|Mean
81126|NCT00992719|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination as well as 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||participants|||Number
81127|NCT00992719|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post vaccination|All participants receiving the vaccination and who reported temperatures are included in the safety cohort. One participant did not report temperatures. Analyses are as treated.||participants|||Number
81128|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
81129|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had cord blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.||participants|||Number
81130|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.||participants|||Number
81131|NCT00992719|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
81132|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
81133|NCT00992719|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.||participants|||Number
81134|NCT00992719|Primary|Number of Births With Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All births are included in this outcome measure. Two participants gave birth to twins and two to triplets, each counted separately.||births|||Number
81135|NCT00992719|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.||participants|||Number
81358|NCT00991081|Secondary|Treatment Interest Scale|Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81136|NCT00992589|Primary|Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. Each of the 9 items will be assigned a numeric score. The total score will be calculated as the sum of all 9 items, and ranges from 0 to 37. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
81137|NCT00992589|Primary|Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) is a 12-item questionnaire that is completed by the primary caregiver at every office or telephonic visit. It has a weekly recall and the items cover the frequency, amount and discomfort attributed to spit-up, refusal or stopping feeding, crying and fussing, hiccups, arching back and stopping breathing or changing color. The total score is calculated as the sum of all 12 scores for the individual questions, and ranges from 0 to 42. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
81138|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Eating Behavior subscale score will be calculated as the sum of the 3 questions regarding eating behavior (Questions 4, 5, 6) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
81139|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Discomfort subscale score will be calculated as the sum of the 3 questions regarding discomfort (Questions, 7, 8, 9) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
81140|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Regurgitation subscale will be calculated as the sum of the 3 questions regarding regurgitation (Questions 1, 2, 3) and will range from 0 to 13. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
81141|NCT00992589|Secondary|The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||number of episodes||Standard Deviation|Mean
81142|NCT00992589|Primary|Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)|Body weight was measured with the participant unclothed and before a feeding during each office visit. In the analysis of weight data, weight will be transformed to the weight-for-age Z-score using World Health Organization Child Growth Standards, taking into account the infant’s age and gender (Borghi E, 2006).|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||Z-score||Standard Deviation|Mean
81143|NCT00992589|Primary|Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.||frequency of Regurgitation||Standard Deviation|Mean
81144|NCT00992459|Secondary|U-PAGN24-hour Excr of NaPBA and HPN-100||24 hours on Day 14 of each treatments|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg||Standard Deviation|Mean
83760|NCT00967694|Primary|Change in Intraocular Pressure During Nitrous Oxide Sedation||Before, during and after administration of nitrous oxide (45 minutes total)|||mmHg (difference in IOP)||95% Confidence Interval|Mean
81146|NCT00992459|Secondary|Cmax for PBA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg/mL||Standard Deviation|Mean
81147|NCT00992459|Secondary|Cmax for PAA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μg/mL||Standard Deviation|Mean
81148|NCT00992459|Secondary|Rate of Adverse Events in Each Treatment Group||29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.||participants|||Number
81149|NCT00992459|Secondary|Number and Severity of Symptomatic Hyperammonemic Crises|Severity of symptomatic hyperammonemic crises was measured by peak ammonia level (µmol/L) when it is >= 100 µmol/L.|29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.||events|||Number
81150|NCT00992459|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA Versus HPN-100|NaPBA treated arm: total 345 blood samples were collected. HPN-100 treated arm: 343 blood samples were collected.|on Day 14 and Day 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||samples|blood samples||Number
81151|NCT00992459|Secondary|Maximum Ammonia Values Observed on NaPBA Versus HPN-100|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||µmol/L||Standard Deviation|Mean
81152|NCT00992459|Secondary|Correlation Between Urinary Phenylacetylglutamine (PAGN) Excretion Over 24 Hours (U-PAGN24-hour Excr) and Venous Ammonia - Area Under the Concentration-time Curve From Time 0 (Predose) to 24 Hours (AUC0-24)|The correlation between 24-hour urinary phenylacetylglutamine (PAGN) excretion (U-PAGN24-hour Excr) and venous ammonia AUC0-24 was summarized and the correlation was tested using the Spearman rank-order correlation.|28 Days|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||correlation coefficient|||Number
81153|NCT00992459|Primary|The Primary Endpoint Was the 24-hour Area Under the Curve for Blood Ammonia (NH324-hour AUC) on Days 14 and 28.|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. Arm A day 14 and Arm B day 28 data were combined as a NaPBA treatment Arm. Arm B day 14 and Arm A day 28 data were combined as a HPN-100 treatment Arm.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44||μmol∙h/L||Standard Deviation|Mean
81154|NCT00992433|Primary|Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
81155|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
81156|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
81157|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
81359|NCT00991081|Secondary|Satisfaction Scale|Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81158|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
81159|NCT00992433|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
81160|NCT00992433|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. One participant did not record temperatures. Analyses are as treated.||Participants|||Number
81161|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
81162|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
81163|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81164|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 and Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81165|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81166|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81167|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81360|NCT00991081|Secondary|Communication Scale|Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81168|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81169|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81170|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81171|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81172|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81173|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81174|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81216|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81175|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81176|NCT00992433|Primary|Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81177|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81178|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81179|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81180|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81181|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81228|NCT00992186|Secondary|Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)||Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.||mcg*day/mL||Standard Deviation|Mean
81182|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.||Participants|||Number
81183|NCT00992407|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52|The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: ranging from 0 to 3), and a global clinical rating of akathisia (GCRA), ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Units on a scale||Standard Deviation|Mean
81184|NCT00992407|Secondary|Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52|The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Full Range|Median
81185|NCT00992407|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52|The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Full Range|Median
81186|NCT00992407|Secondary|Change From Baseline in Number of Outpatient Clinic Visits at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 1 question is related to number of outpatient clinic visits. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||number of visits||Standard Deviation|Mean
81187|NCT00992407|Secondary|Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to travelling fee for outpatients, hospitalization travelling fee and salary paid a participant before being ill. Mean-calculations were done for all questions. Travelling fee, hospitalization travelling fee and salary paid were assessed for every past three months. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Won||Standard Deviation|Mean
81188|NCT00992407|Secondary|Change From Baseline in Total Outpatients and Inpatients Hours at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 2 questions are related to total outpatients and inpatients hours. Total outpatients hours and total inpatient hours indicate the total hours spent by outpatients and inpatients respectively at Investigator site.Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||hours||Standard Deviation|Mean
81189|NCT00992407|Secondary|Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to days of hospitalization, number of days affected by participants and family per participant within reporting interval score. Mean-calculations were done for all questions. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||days||Standard Deviation|Mean
81229|NCT00992186|Secondary|Maximum Observed Serum Concentration (Cmax)|The maximum observed analyte concentration was measured.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab.||mcg/mL||Standard Deviation|Mean
81190|NCT00992407|Secondary|Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 4 questions are related to number of members for outpatients, number of members visiting inpatients, number of affected members and number of visiting inpatients. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||participants||Standard Deviation|Mean
81191|NCT00992407|Secondary|Change From Baseline in Drug Attitude Inventory–10 (DAI-10) Score at Week 52|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. Score ranges from (-) 10 to 10. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
81192|NCT00992407|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52|The SUMD scale is a semi-structured scale that assesses participant's awareness of and insight into their illness, that is, the present level of insight. SUMD total score ranges from 0-27, with higher scores indicating poorer insight. The scale consists of nine items score ranging from 1 to 3, with higher scores indicating poorer insight. Score for each item is summed to produce the total score.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
81193|NCT00992407|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
81194|NCT00992407|Secondary|Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52|Psychosocial Well-being Index (PWI) is a questionnaire about how the participant feels and how the things had been going with them. Total score ranges from 0 to 135, where lower score indicates worsening.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
81195|NCT00992407|Secondary|Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52|The TOM scale is used to assess the ability of participant to infer other's mental states. It includes recognition that other individuals experience thoughts, feelings, intentions, and desires. It is measured by cartoon task, score ranging from 0-30 and stork task which includes stork task set A (false belief), stork task set B (double bluff, white lie, persuasion, misunderstanding), and physical story, score ranging from 0-12, 0-26 and 0-24 respectively. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
81196|NCT00992407|Secondary|Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The CPT assessed CPT (Omissions) and CPT (Commissions). Omission errors indicate the number of times the target was presented, but the participant did not respond/click the mouse. High omission rates indicate that the participant is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors indicate the number of times the participant responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors indicates inattention in general.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Errors||Standard Deviation|Mean
81197|NCT00992407|Secondary|Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. Working memory was assessed using Controlled Oral Word Association Test (COWAT) which measured verbal fluency and is a sub-test of the multilingual aphasia examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. More words indicate improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Words||Standard Deviation|Mean
81198|NCT00992407|Secondary|Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The Trail Making Test is composed of two Parts, A and B. Part A consists of 25 circles printed on a sheet of paper. Each circle contains a number from 1 to 25. The participant's task is to connect the circles with a pencil line as quickly as possible, beginning with the number 1 and proceeding in numerical sequence. Part B consists of 25 circles numbered from 1 to 13 and lettered from A to L. The task in Part B is to connect the circles, in sequence, alternating between numbers and letters. Here, mean number of seconds are represented required to complete each Part.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Seconds||Standard Deviation|Mean
81199|NCT00992407|Secondary|Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The VWM was measured by Korean-Wechsler Adults Intelligence Scale (K-WAIS), which consists of two subscales, the Verbal scale (6 subtests) and the Performance scale (5 subtests). The verbal tests were: information, comprehension, arithmetic, digit span, similarities, and vocabulary. Arithmetic and Digit Span test of Verbal WAIS scales was conducted. Arithmetic test (arithmetic questions were asked orally) involved calculations that measured concentration while manipulating mental mathematical problems. Digit span test (children were asked to repeat the orally given sequences of numbers either as heard or in reverse order) measured attention, concentration, and mental control. Here, mean number of correct responses in limited time period are reported for arithmetic (calculation) and Digit span. Increase in number of correct response indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||Correct responses||Standard Deviation|Mean
81200|NCT00992407|Secondary|Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52|For emotional and SFS, mean scores of neuroticism-extroversion-openness (NEO) personality test, relationship style questionnaire (RSQ), state-trait anger expression inventory (STAXI), positive affect and negative affect schedule (PANAS), emotional intelligence (EI), beck depression inventory (BDI), and beck anxiety inventory (BAI) scales were calculated. Score ranges for each category as:60-300 for NEO, 30-150 for RSQ, 20-80 for STAXI, 20-100 for PANAS, 8-172 for EI, 0-63 for BDI and BAI. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
81201|NCT00992407|Secondary|Change From Baseline in Social Functioning Scale (SFS) Score at Week 52|Social Functioning Scale (SFS) scores from 0 to 223 wherein, following categories were involved: Social Engagement (Score Range 0-15); Interpersonal Communication (Score Range 0-9); Recreational Activities (Score Range 0-45); Social Activities (Score Range 0-66; Independence Competence (Score Range 0-39); Independence Performance (Score Range 0-39); Occupational Activity (Score Range 0-10). Total score is sum of all sub scores and higher score indicates better level of social functioning.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."||units on a scale||Standard Deviation|Mean
81202|NCT00992407|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
81203|NCT00992407|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
81204|NCT00992407|Primary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52|The PSP assesses degree of participant’s dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline and Week 52|Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.||units on a scale||Standard Deviation|Mean
81205|NCT00992394|Secondary|Physician Global Assessment (PGA) of Disease Activity at Week 52|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Week 52|The modified intent-to-treat (mITT) population will be the primary efficacy population and will correspond to all randomized subjects who have a baseline PGA and at least one postbaseline PGA.||Units on a scale||Standard Deviation|Mean
81206|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81207|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81208|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81209|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81210|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81211|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81212|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81213|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81214|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81215|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81217|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81218|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81219|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81220|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of Participants|||Number
81221|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Number of participants|||Number
81222|NCT00992394|Secondary|Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.||Units on a scale||Standard Deviation|Mean
81223|NCT00992394|Primary|Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks*7days + 1.|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
81224|NCT00992264|Primary|Treatment Utilization for Smoking Cessation|confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program|12 months|Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment.||% of participants using adjunct treatmen|||Number
81225|NCT00992264|Primary|Smoking Abstinence|7 day point prevalent abstinence|12 months|Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample.||percentage of abstinent participants|||Number
81226|NCT00992186|Other Pre-specified|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Status Score|A worsening in ECOG performance status score was defined as greater than or equal to 1-point increase from Baseline. Time to worsening is defined as the number of days from first dose to the first day of worsening in ECOG score, or death, whichever occurred first. ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all selfcare, 3=Capable of limited selfcare, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no selfcare, totally confined to bed or chair, 5=Dead.|Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.||Days||95% Confidence Interval|Median
81227|NCT00992186|Secondary|Half-life (t1/2)|The time measured for the serum concentration to decrease by one half.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.||Days||Full Range|Median
81230|NCT00992186|Secondary|Minimum Observed Serum Concentration (Cmin)||Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
81231|NCT00992186|Secondary|Duration of Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.|||||
81232|NCT00992186|Secondary|Time to Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.|||||
81233|NCT00992186|Secondary|Percentage of Participants With Pain Response|Pain response is defined as 2-point decrease from Baseline in ‘worst pain’ intensity score (item 3) on the Brief Pain Inventory (BPI) questionnaire. The BPI is a nine-item questionnaire with 0 to 10 numeric rating scales in response to each item, where 0=No pain and 10=Pain as bad as you can imagine. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab, had Baseline BPI ‘worst pain’ intensity score (item 3) more than or equal to 2, and at least 1 post-treatment pain evaluation. Participants with disease progression were considered to be evaluable, regardless of the post-dose evaluation.||Percentage of participants|||Number
81234|NCT00992186|Secondary|Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response|Urinary NTx response for participants with elevated NTx level at Baseline (more than or equal to 50 nanomole per millimole (nmol/mmol)) is defined as a 30% reduction from Baseline NTx value, confirmed by a second NTx value 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had elevated urinary NTx level at Baseline (more than or equal to 50 nmol/mmol) and at least 1 post-treatment urinary NTx measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
81235|NCT00992186|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response for participants with elevated PSA levels at Baseline (more than or equal to 5 nanogram per milliliter (ng/mL) is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value measurement 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a Baseline PSA more than or equal to 5 ng/mL and at least 1 post-treatment PSA measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
81236|NCT00992186|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of initiation of study treatment to death due to any cause. Participants were followed for 1 year after the last administration of carlumab for survival or until the end of study, whichever occurs first. For participants with unknown survival status as of the data cutoff date, OS was censored at the last date that the participant was known to be alive.|Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.||Days||Full Range|Median
81237|NCT00992186|Secondary|Progression-Free Survival (PFS)|The PFS is defined as the time from the date of initiation of study treatment to the date of initial documented skeletal or extra-skeletal progressive disease, or date of death, whichever occurs first. A participant is considered to have extra-skeletal disease progression if the disease has progressed as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria. A participant is considered to have skeletal disease progression if they have 1 post-baseline bone scan demonstrating 2 or more new skeletal lesions compared to Baseline and confirmed by a second bone scan 6 to 12 weeks later or with evidence of clinical progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.||Days||95% Confidence Interval|Median
81238|NCT00992186|Secondary|Percentage of Participants With Objective Tumor Response|Objective response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a measurable, non-measurable or bone lesion at Baseline and had at least 1 post-treatment tumor evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
81361|NCT00991081|Secondary|Trust Scale|Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81239|NCT00992186|Primary|Percentage of Participants With Composite Response|The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had at least 1 post-baseline disease evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
81240|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening|maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)|baseline, 4 months|Participants completing the 4-month follow-up||participants|||Number
81241|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold|measurements were obtained by placing examiner’s index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).|baseline, 4 months|Participants completing the 4-month follow-up||participants|||Number
81242|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|6 weeks|||participants|||Number
81243|NCT00992108|Primary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|4 months|participants who completed the 4-month follow-up||participants|||Number
81244|NCT00992056|Primary|Change in 24-hour Mean Systolic Blood Pressure by ABPM From Day 5 of Low Sodium to Day 10 of High Sodium||Day 5, Day 10|24 subjects were randomized. Three withdrew informed consent during the study. One completed all phases of the study but had a faulty ABPM reading on the last determination||mmHg||95% Confidence Interval|Mean
81245|NCT00992017|Secondary|Response to Seasonal Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry|Pregnant women who received the first H1N1 immunization.||titer||Inter-Quartile Range|Median
81246|NCT00992017|Secondary|Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 PBMC and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose|The pregnant women who had not delivered prior to the evaluation, had received all doses of vaccine up to that timepoint and had sufficient samples for testing.||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
81247|NCT00992017|Secondary|Infant GMT of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at birth and at 3 and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.||units on the HAI titer scale||95% Confidence Interval|Geometric Mean
81248|NCT00992017|Secondary|Maternal Geometric Mean Titers (GMT) of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery|The population consists of eligible women with nonmissing HAI titers, who had not delivered before the evaluation post first or second dose, and received all vaccines up to that point, respectively. The N for analyses after the first and second vaccinations, at delivery, 3 and 6 months after were 104, 94, 102, 92 and 58, respectively.||titers||95% Confidence Interval|Geometric Mean
81249|NCT00992017|Secondary|Percent of Infants With an HAI Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at birth (via cord blood) and at 3 months and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.||Percent of participants||95% Confidence Interval|Number
81250|NCT00992017|Secondary|Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at delivery of the baby, and at 3 months and 6 months after delivery|The population consists of eligible pregnant women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for the analyses of HAI titers at delivery, and at 3 and 6 months after were 102, 92 and 58, respectively. Only some women had a clinic visit at 6 months post delivery.||Percent of participants||95% Confidence Interval|Number
81251|NCT00992017|Primary|Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and at 10 days after second dose of study vaccine|The analysis population consists of the eligible pregnant women with nonmissing HAI titers, who had not delivered prior to the evaluation, and had received all doses of vaccine up to that timepoint. The N for the analyses of HAI titers after the first and second vaccinations were 118 and 108, respectively.||Percent of participants||95% Confidence Interval|Number
81252|NCT00992017|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|All 128 pregnant women who received at least one vaccination are included.||Participants|||Number
81253|NCT00992017|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included.||Participants|||Number
81254|NCT00992017|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|Shows the number of participants who had at least one adverse event (AE) in each category. These include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included in this analysis.||Participants|||Number
81255|NCT00991952|Primary|Overall Response Rate|Response was determined as indicated in the protocol.|From the start of treatment for up to 3 months|||participants|||Number
81256|NCT00991939|Secondary|The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy||Through 1 year after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81257|NCT00991939|Secondary|The Percentage of Patients Not Completing Study Therapy||49 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81258|NCT00991939|Secondary|The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81259|NCT00991939|Secondary|Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey||Weeks 4, 8, and 52 after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81260|NCT00991939|Secondary|The Percentage of Patients Undergoing Splenectomy||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81261|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81262|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81263|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81264|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry||Through 60 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81265|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81266|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81267|NCT00991939|Secondary|The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365||365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81268|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.|||||
81269|NCT00991939|Primary|The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.||From 60 days through 365 days after study entry.|||percentage of subjects|||Number
81270|NCT00991809|Secondary|Analgesic Effects (Pain Threshold and Tolerance) on Mechanical Quantitative Sensory Testing||8 sessions over 4-6 weeks||||||
81271|NCT00991809|Secondary|Change in Pain Threshold (Time to Pain Onset) of Cold Pressor Testing||8 sessions over 4-6 weeks||||||
84939|NCT00956943|Primary|Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment|quit rate verified with carbon monoxide breath sample (abstinence: less than or equal to 10ppm)|After 8 weeks of treatment with the patch, outcome will be measured.|intent to treat||participants|||Number
81273|NCT00991510|Secondary|Summary of Participants With Adverse Events|"Summary of adverse events across three study time periods. The on-treatment time frame spanned the time during which study drug was administered. Relation to study drug was assessed by the investigator.~The Adverse Event count includes serious and non-serious AEs. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above.~Severity was measured on a three-point scale: mild, moderate, severe."|Day 1 up to Day 112|Safety population. One participant discontinued the study prior to Period II so the Myfenax # participants analyzed is one less than the CellCept arm.||participants|||Number
81274|NCT00991510|Secondary|Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil|Tmax was directly obtained from measured values.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||hours||Standard Deviation|Mean
81275|NCT00991510|Secondary|Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)|PTF was calculated as: (Cmax-Cmin)/(AUCt/t)*100|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||percentage of AUC for a dosing interval||Standard Deviation|Mean
81276|NCT00991510|Secondary|Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)|Cpd was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||µg /ml||Standard Deviation|Mean
81277|NCT00991510|Secondary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil|Cmin was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||µg /ml||Standard Deviation|Mean
81278|NCT00991510|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil|Cmax was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||µg /ml||Standard Deviation|Mean
81279|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil|For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||hour* µg /ml||Standard Deviation|Mean
81280|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil|Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.||hour* µg /ml||Standard Deviation|Mean
81281|NCT00991458|Secondary|Worst Outcome Post-LASIK Surgery in Reading Speed Assessment|Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X [Number of words on card - (reading errors)]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.||Words Per Minute (WPM)||Standard Deviation|Mean
81282|NCT00991458|Secondary|Percentage of Patients With Cumulative Poor Vision|Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.|Month 3, Month 4, Month 5, Month 6|Intent to treat: all randomized patients.||Percentage of Patients|||Number
81283|NCT00991458|Secondary|Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment|The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.||Seconds||Standard Deviation|Mean
81362|NCT00991081|Secondary|Morisky Adherence Scale|Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance|12 weeks after Target Quit Date|Follow-up treatment satisfaction analyses includes only those participants not lost to follow-up (n = 30)||units on a scale||Standard Deviation|Mean
81284|NCT00991458|Primary|Time to Cure|Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.|6 Months|Modified Intent to Treat: all randomized and treated patients with both eyes having Post-LASIK surgery and corneal sensitivity measurements of < 25 mm in the 3 central regions at Post-Surgery Week 1.||Days||Inter-Quartile Range|Median
81285|NCT00991341|Secondary|Any Mechanical Ventilation More Than 48 Hours Post-operation||48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
81286|NCT00991341|Secondary|Days Alive and Ventilator Free Through Post-op Day 28||Through post-op day 28|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||days||Standard Deviation|Mean
81287|NCT00991341|Secondary|Days to First Solid Food|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative solid food.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.||days||Standard Error|Mean
81288|NCT00991341|Secondary|Days to First Bowel Movement|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative bowel movement.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.||days||Standard Error|Mean
81289|NCT00991341|Secondary|Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT. Therefore, to protect patient confidentiality, results were not entered.|||||
81290|NCT00991341|Secondary|Change in Bilirubin From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||mg/dL||Standard Deviation|Mean
81291|NCT00991341|Secondary|Change in Lactate From Pre-operative Value to Worst Post-operative Value|The arterial lactate levels were adjusted to make them comparable to venous lactate levels.|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||mmol/L||Standard Deviation|Mean
81292|NCT00991341|Secondary|Change in Troponin-I From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||ng/mL||Standard Deviation|Mean
81293|NCT00991341|Secondary|Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||mg/dL||Standard Deviation|Mean
81294|NCT00991341|Secondary|Ventilation Duration|Because some subjects may experience multiple periods of ventilator use, the total duration that they were on a ventilator was compared between the two groups.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||days||Standard Deviation|Mean
81295|NCT00991341|Secondary|Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
81296|NCT00991341|Secondary|Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
81297|NCT00991341|Secondary|Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
81298|NCT00991341|Secondary|Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.|The follow-up MODS used to calculate 28-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 28, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 28-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through 28 days post-surgery, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||MOD score points||Standard Deviation|Mean
81299|NCT00991341|Secondary|All-cause Mortality|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.|28 days post-surgery|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||participants with event|||Number
81300|NCT00991341|Primary|The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.|The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject’s worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).||MOD score points||Standard Deviation|Mean
81301|NCT00991302|Secondary|Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)|"The Kaplan-Meier estimate of the cumulative probability of experiencing a grade 3 or 4 adverse event by week 72.~New Grade 3 or 4 signs, symptoms were identified by MedDRA preferred term. Events were included regardless of participant status on ART. If a participant had multiple reports of the same event, only the event reported at the highest grade were included.~Time was measured from the study entry until the date of the first new grade 3 or 4 adverse event. Participants lost to follow-up prior to reaching an adverse event endpoint or not documented to have reached an adverse event endpoint at the end of the study had their endpoint censored at the date of their last visit."|From study entry to week 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
81302|NCT00991302|Secondary|Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score|"The GSES is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one’s actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate participant’s stronger belief in self-efficacy.~The GSES score was sum of all responses. The range was from 0 to 40 scores: any unfinished question got a score of zero."|At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||scores on a scale||Inter-Quartile Range|Median
81303|NCT00991302|Secondary|Virologic Suppression|Virologic suppression was defined as HIV-1 RNA <=200 copies/mL at week 24, 48, and 72. The results obtained within +/- 12 weeks of 24, 48, and 72 weeks were included. If there were multiple HIV-1 RNA measurement within the specified window, the HIV-1 RNA result closest to the center of the window was selected.|At week 24, 48, 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||percentage of participants||95% Confidence Interval|Number
81304|NCT00991302|Secondary|Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48|"The Kaplan-Meier estimate of the cumulative probability of initial antiretroviral (ARV) treatment regimen for any reason by week 48.~Time to ARV treatment regimen change was defined as first time to change in the drug class of participant's ART regimen for any reason from study entry. Participants completing the study without a change in the drug class of their ART regimen were censored at their last visit."|From study entry to week 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
81305|NCT00991302|Secondary|Mean Self-reported Adherence Score Over a One-month Recall|The mean of participant's average self-reported adherence score over a one-month recall across visit week 4, 12, 24, 36, 48, 60, and 72; missing values were ignored.|Weeks 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||percentage of adherence score||Inter-Quartile Range|Median
81306|NCT00991302|Primary|Mean Self-reported Adherence Score (%) Over a One-month Recall|"The adherence self-report questionnaire captured adherence at an Antiretroviral Therapy (ART) regimen over a one-month recall (0-100): 0 means none of anti-HIV medications were taken, 100 means every single dose of anti-HIV medications were taken. The primary endpoint evaluated for each participant was the average self-reported adherence over a one-month recall across each of their study visit week 4, 12, 24, 36, and 48: missing values were ignored.~Note: This was a change to the primary endpoint as described in the study protocol. This was due to an update to ACTG Case Report Form (CRF) that captured self-report adherence. Since the data captured on this form captured adherence over a longer timeframe and allowed for more variability in response, it was anticipated this endpoint would provide greater power to assess treatment differences."|At weeks 4, 12, 24, 36, and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||percentage of adherence score||Inter-Quartile Range|Median
81307|NCT00991289|Secondary|Number of Participants With HCV Genotype 1|Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY).|Week 0|All participants who enrolled, except one participant who was found to have been ineligible after entry.||participants|||Number
81308|NCT00991289|Secondary|Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.|Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test.|Weeks 0, 4|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HCV viral load measurements available at entry and at Week 4 were analyzed.||log10 IU/mL||Inter-Quartile Range|Median
81309|NCT00991289|Secondary|Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry|HOMA-IR was calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had fasting insulin and fasting glucose measurements available at entry and the respective post-entry time point: 56 at Week 16, 39 at Week 28, 27 at Week 52 and 22 at Week 76.||percentage of HOMA-IR at study entry||Inter-Quartile Range|Median
81310|NCT00991289|Secondary|Percent Change in Fasting Glucose Level From Study Entry|Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had FGLUC measurement available at entry and the respective post-entry time point: 58 at Week 16, 41 at Week 28, 29 at Week 52 and 24 at Week 76.||percentage of FGLUC at study entry||Inter-Quartile Range|Median
81311|NCT00991289|Secondary|Percent Change in Fasting Insulin Level From Study Entry|Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had FINS measurement available at entry and the respective post-entry time point: 58 at Week 16, 40 at Week 28, 28 at Week 52 and 23 at Week 76.||percentage of FINS at study entry||Inter-Quartile Range|Median
81312|NCT00991289|Secondary|Change in Hemoglobin Level From Study Entry|Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HGB measurement available at entry and at the respective post-entry time point: 65, 65, 63, 60, 55, 51, 45, 38, 39, 34, 31, 32, 31 and 29 participants at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 76, respectively.||g/dL||Inter-Quartile Range|Median
81313|NCT00991289|Secondary|Number of Participants With Adverse Events of Grade 2 or Higher|Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to up to week 76|All participants who enrolled, except one participant who was found to have been ineligible after entry.||participants|||Number
81363|NCT00991081|Primary|Continuous Abstinence at 12 Weeks Post Target Quit Date|"Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as abstinent. All others were recorded as not abstinent."|12 weeks after Target Quit Date|All randomized participants were included in the data analysis.||participants|||Number
81314|NCT00991289|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|Rapid virologic response (RVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 8|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 8 HCV viral load result were considered non-responders.||percentage of participants||90% Confidence Interval|Number
81315|NCT00991289|Secondary|Percentage of Participants With Sustained Virologic Response (SVR)|Sustained virologic response (SVR) was defined as undetectable HCV viral load (<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders.|24 weeks after treatment discontinuation|All participants who enrolled, except one who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without HCV RNA from 24 weeks after treatment discontinuation, non-EVRs and those with detectable HCV RNA at Week 28, were considered non-responders.||percentage of participants||90% Confidence Interval|Number
81316|NCT00991289|Primary|Percentage of Participants With Early Virologic Response (EVR)|Early virologic response (EVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Weeks 0, 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.||percentage of participants||90% Confidence Interval|Number
81317|NCT00991289|Primary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Complete early virologic response (cEVR) was defined as undetectable HCV viral load (<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.||percentage of participants||90% Confidence Interval|Number
81318|NCT00991276|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)|RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
81319|NCT00991276|Secondary|Medical Outcomes Study - Sleep Scale (MOS-SS)|MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity[range 0-24 hours], optimal sleep[range 0-1: 0= <7 or >8 hours;1=7/8 hours]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed for particular subscale for each arm group respectively."||units on a scale||95% Confidence Interval|Least Squares Mean
81320|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale|SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep [in minutes]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81321|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
81364|NCT00990964|Primary|Subjects Without a Left-heart Lead and Delivery Catheter Related Complication|A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC).|Implant to 3 months|||participants|||Number
81322|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81323|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||awakenings||95% Confidence Interval|Least Squares Mean
81324|NCT00991276|Secondary|Hourly and Quarterly Assessment of Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of time asleep||95% Confidence Interval|Least Squares Mean
81325|NCT00991276|Secondary|Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)|PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
81326|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Arousals (NASO)|NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||arousals||95% Confidence Interval|Least Squares Mean
81327|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||awakenings||95% Confidence Interval|Least Squares Mean
81328|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||awakenings||95% Confidence Interval|Least Squares Mean
81365|NCT00990964|Primary|Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter|Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.|Implant|||participants|||Number
81329|NCT00991276|Secondary|Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)|WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."||minutes||95% Confidence Interval|Least Squares Mean
81330|NCT00991276|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Percentage of time asleep||95% Confidence Interval|Least Squares Mean
81331|NCT00991276|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81332|NCT00991276|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81333|NCT00991276|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81334|NCT00991276|Secondary|Latency to Persistent Sleep (LPS)|LPS, as determined by PSG, was number of epochs from the beginning of the recording (“lights-out”) to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81335|NCT00991276|Secondary|Latency to Stage R Sleep (LREM)|LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81336|NCT00991276|Secondary|Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale|CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected.|Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants|||Number
81366|NCT00990821|Primary|Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V|AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.|Up to 72 Hours Post Dose|All participants in Part V who had at least one period of AUC data were included in the evaluation of pharmacokinetics. Participants without sufficient concentration data for an AUC calculation included: 6 participants in the Aprepitant (125 mg) , 8 participants in the MK-0517 (100 mg) group, and 5 participants in the MK-0517 (115 mg) group.||ng*hr/mL||Standard Deviation|Least Squares Mean
81337|NCT00991276|Secondary|International Restless Legs Syndrome Study Group Rating Scale (IRLS)|IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
81338|NCT00991276|Secondary|Arousal Index (NASOI)|Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||arousals/hour||95% Confidence Interval|Least Squares Mean
81339|NCT00991276|Secondary|Number of Arousals (NASO)|NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||arousals||95% Confidence Interval|Least Squares Mean
81340|NCT00991276|Secondary|Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||awakenings||95% Confidence Interval|Least Squares Mean
81341|NCT00991276|Secondary|Periodic Limb Movement in Sleep Index (PLMSI)|PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
81342|NCT00991276|Secondary|Periodic Limb Movement Index (PLMI)|PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
81343|NCT00991276|Secondary|Restless Legs Syndrome-Next Day Impact (RLS-NDI)|RLS-NDI:participant-rated instrument to assess daytime performance and participant’s previous night’s sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||95% Confidence Interval|Least Squares Mean
81344|NCT00991276|Secondary|Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM [Stage N2] 30-second (30-sec) epoch, Stage 3 Non-REM [Stage N3] 30-sec epoch, or stage rapid eye movement [stage R] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||awakenings||95% Confidence Interval|Least Squares Mean
81500|NCT00989157|Primary|Cmax|The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||ng/ml||Standard Deviation|Mean
81345|NCT00991276|Secondary|Minutes of Stage N1, N2, N3 and R Sleep|Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81346|NCT00991276|Secondary|Subjective Total Sleep Time (sTST)|sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81347|NCT00991276|Secondary|Periodic Limb Movement Arousal Index (PLMAI)|PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||movement/hour||95% Confidence Interval|Least Squares Mean
81348|NCT00991276|Primary|Wake After Sleep Onset (WASO)|WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep [WTDS] epochs + Wake Time After Sleep [WTAS] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)|Intent to Treat (ITT) population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||minutes||95% Confidence Interval|Least Squares Mean
81349|NCT00991185|Primary|CSF:Serum Ratio of Vancomycin|CSF:serum ration of vancomycin|within 1 week of drug administration|||ratio||Full Range|Median
81350|NCT00991081|Secondary|Threat Minimization|Category: Psychological Outcome Instrument: 2-item inventory, Likert scale from 1 to 7 Measures: Perceived presence of factors that would reduce personal smoking risks Range: 2-14 Direction: Higher values represent increased risk minimization|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81351|NCT00991081|Secondary|Self-Efficacy|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Perceived ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased self-efficacy|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81352|NCT00991081|Secondary|Risk Perception|Category: Psychological Outcome Instrument: 4-item inventory, Likert scale from 1 to 5 Measures: Perceived personal health risks from smoking Range: 4-20 Direction: Higher values represent increased perception of risk|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81353|NCT00991081|Secondary|Perceived Control|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Control over ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased sense of control|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81354|NCT00991081|Secondary|Motivation|Category: Psychological Outcome Instrument: Single item, Likert scale from 1 to 7 Measures: Desire to quit smoking Range: 1-7 Direction: Higher values represent increased motivation to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81355|NCT00991081|Secondary|Intention to Quit|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Intention, confidence, and expectation of quitting smoking Range: 3-21 Direction: Higher values represent increased intention to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)||units on a scale||Standard Deviation|Mean
81356|NCT00991081|Secondary|Fatalism|Category: Psychological Outcome Instrument: Powe Fatalism Inventory, 10-item, revised Measures: belief in inevitability of smoking status Range: 0-10 Direction: Higher values represent increased fatalism beliefs|12 weeks after Target Quit Date|Follow-up psychological outcome analyses include only those participants not lost to follow-up (n = 30)||units on a scale||Standard Deviation|Mean
81357|NCT00991081|Secondary|Depression|Category: Psychological Outcome Instrument: Center for Epidemiologic Studies Depression Scale (CES-D) Measures: Interest in participating in recommended treatment plan Range: 0-60 Direction: Higher values represent increased symptoms of depression|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 30)||units on a scale||Standard Deviation|Mean
81367|NCT00990769|Secondary|Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)|Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.|Within 30 minutes of arrival in recovery room|All patients were analyzed.||units on a scale||Standard Deviation|Mean
81368|NCT00990769|Secondary|Time to Emergence From Anesthesia|The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.|After the completion of surgery|All patients were analyzed||minutes||Standard Deviation|Mean
81369|NCT00990769|Primary|Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)|The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 – 20, with higher scores indicating greater severity of emergence agitation.|Within 30 minutes of arrival in recovery room|All patients in each group were analyzed.||units on a scale||Standard Deviation|Mean
81370|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH||Over the 12-week treatment period|||Occurrences per participant||Standard Deviation|Mean
81371|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline||Over the 12-week treatment period|||Occurrences per participant||Standard Deviation|Mean
81372|NCT00990704|Secondary|Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia|||Percentage of participants|||Number
81373|NCT00990704|Secondary|Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia|||Percentage of participants|||Number
81374|NCT00990704|Secondary|Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks||Baseline and the last 3 weeks (Weeks 11, 12, and 13)|||pg/mL||Standard Deviation|Mean
81375|NCT00990704|Secondary|Mean iPTH at Each Visit||Screening (up to 2 weeks before Baseline) to Week 13|||pg/mL||Standard Deviation|Mean
81376|NCT00990704|Secondary|The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks||During the last 3 weeks (Weeks 11, 12, and 13)|||Percentage of participants|||Number
81377|NCT00990704|Primary|The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.||Baseline and the last 3 weeks (Weeks 11, 12, and 13)|All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment.||Percentage of participants|||Number
81378|NCT00990652|Secondary|Overall Survival Rate at 6 Months|The rate of overall survival at 6 months (regardless of disease progression) was calculated.|After 6 months on study|The 6-month overall survival rate was based on a median of 168 days of follow-up.||percentage of participants|||Number
81379|NCT00990652|Secondary|Overall Survival (in Days)||Days 1, 4, 8 pre-surgery, once per cycle (every 4 weeks) while on treatment post-surgery, and then every 3 months up to 2 years during follow-up|||days||95% Confidence Interval|Median
81380|NCT00990652|Other Pre-specified|Pharmacokinetics of Bortezomib in Tumor Tissue Taken at the Time of Surgery.||Tissue sample taken at the time of surgery for all patients.||||||
81381|NCT00990652|Other Pre-specified|Change in MGMT Methylation Status as Well as Other Methylation Patterns in Plasma|To determine MGMT methylation status as well as other methylation patterns in plasma|Blood samples drawn on days 1, 4, and 8 pre-surgery, and then prior to cycle 1 and every 2 cycles thereafter||||||
81382|NCT00990652|Secondary|Number of Grade 1, 2, 3, 4, and 5 Adverse Events Observed During Study Treatment (Defined by CTCAE v 3.0)|"Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Days 1, 4, 8 pre-surgery, and then at the start of every cycle (approximately every 4 weeks) post-surgery while on treatment|||adverse events|||Number
81383|NCT00990652|Secondary|Number of Participants Achieving a Response to Treatment (Either Complete or Partial Response) as Defined by MacDonald Criteria|"This measure was assessed only in patients who had residual tumor post-operatively. Per MacDonald Criteria:~Complete Response requires complete disappearance of all measurable & evaluable disease, no new lesions, no evidence of non-evaluable disease, and only minimal or no use of steroids.~Partial Response is defined as >= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, and no new lesions. Responders must be on the same or decreasing doses of steroid.~Response was assessed by imaging (MRI or CT with contrast)."|Day of treatment post-surgery and then approximately every 8 weeks thereafter until off treatment|Only those participants who had residual tumor remaining after surgical resection were evaluated for this outcome.||participants|||Number
81413|NCT00989989|Secondary|Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
81384|NCT00990652|Primary|Number of Patients Surviving Without Disease Progression After 6 Months|"Patients will be monitored from date of first treatment to the date of first observation of progressive disease, non-reversible neurologic progression or increasing steroid requirements, death due to any cause, or early discontinuation of treatment. Progression-free survival will be defined as the absence of any of the above after 6 months.~Progression (defined by MacDonald Criteria) is a 25% increase in the sum of products of all measurable lesions over smallest sum observed compared to baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to the cancer)."|From date of first treatment until disease progression, death, or early discontinuation of treatment (up to 24 months)|||participants|||Number
81385|NCT00990652|Other Pre-specified|Correlation of Expression of NFKBIA Gene With Response to Therapy and Survival.|The effects of bortezomib on the endogenous modulators of NF-Kappa B pathways, especially the NFKBIA gene (nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor, alpha) were assessed using novel assay technology; expression of NFKBIA was then correlated with response to therapy and patient survival.|Tissue samples for analysis were obtained on the day of surgery for all patients||||||
81386|NCT00990561|Secondary|Maintenance of Psoriasis Improvement With Lac-Hydrin Lotion After Discontinuation of Steroid Therapy||6 weeks||||||
81387|NCT00990561|Primary|Change in Modified Psoriasis Area Severity Index (PASI) Score|PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).|2 weeks|This was a pilot study and the number was based on the available budget to perform the study.||units on a scale||Full Range|Mean
81388|NCT00990509|Primary|Mean Intracerebral Hemorrhage (ICH) Volume|11 of 14 participants received a Day 5 MRI. Mean ICH volume based on 11 participants is presented.|Day 5 MRI|||cc||Standard Deviation|Mean
81389|NCT00990509|Primary|Assessment of Safety of Albumin Administration in Primary ICH|Serious adverse events. Specific safety outcomes assessed: frank pulmonary edema as visualized on chest X-Ray, congestive heart failure, neurological deterioration (4-point worsening on NIHSS), death|Through Day 90 following enrollment|||events|||Number
81390|NCT00990509|Primary|Mean Hyperintense Acute injuRy Marker (HARM)|Hyperintense Acute injuRy Marker (HARM) characterizes the frequency and severity of blood brain barrier disruption. Mean HARM is assessed on the post-contrast study using a previously developed 5 point scale (0 to 5).). A score of 0 indicates no HARM, whereas a score of 5 indicates diffuse and generalized HARM. 11 of 14 participants received a Day 5 MRI. HARM reads could only be performed on 4 of the 7 placebo subjects due to insufficient sequences or presence of subarachnoid blood. Mean HARM score is presented.|Day 5 MRI|||points|||Number
81391|NCT00990340|Secondary|Subject-reported Overall Satisfaction Following the End of Each Period of the Study.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
81392|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
81393|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like arms were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|2 weeks|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
81394|NCT00990340|Secondary|Subject-reported Injection Pain Immediately Following Administration.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Least Squares Mean
81395|NCT00990340|Primary|Subject-reported Injection Anxiety Immediately Before Administration|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.||Scores on a scale||Standard Deviation|Mean
81396|NCT00990184|Secondary|Glucose Disappearance Rate|Rate of fall of glucose in the blood|Baseline and 8 weeks|||percentage of glucose/min||Standard Error|Mean
81397|NCT00990184|Secondary|Insulin Sensitivity|"Tissue response to circulating insulin in the blood. Insulin sensitivity is measured using a mathematical model that quantifies the fractional rate of change in glucose concentrations per unit of insulin. Low values are insulin resistant and high values are insulin sensitive. *Please note: the -1 in the Unit of Measure should be a superscripted value."|Baseline and 8 weeks|||min-1 per pmol/L||Standard Error|Mean
81398|NCT00990184|Primary|Acute Insulin Response (AIRg) to Intravenous Glucose|Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration.|Baseline and 8 weeks|Subjects who completed the study||pmol/1*min||Inter-Quartile Range|Median
81399|NCT00990106|Secondary|Alcohol Use Disorders Identification Test – Consumption (AUDIT-C)||Baseline, Weeks 7, 11 and 15||||||
81400|NCT00990106|Secondary|Penn Alcohol Craving Scale (PACS)||Baseline, Weeks 7, 11 and 15||||||
81401|NCT00990106|Secondary|SF-12V||Baseline, Weeks 7, 11 and 15||||||
81402|NCT00990106|Secondary|Quality Of Life Inventory (QOLI)||Baseline, Weeks 7, 11 and 15||||||
81403|NCT00990106|Secondary|Patient Health Questionnaire-9 (PHQ-9)||Baseline, Weeks 7, 11 and 15||||||
81404|NCT00990106|Secondary|Hamilton Depression Scale (HAM-D)||Baseline, Weeks 7, 11 and 15||||||
81405|NCT00990106|Secondary|CAPS Symptom Clusters (Reexperiencing/Intrusions, Numbing/Avoidance, and Hyperarousal)||Baseline, Weeks 7, 11 and 15||||||
81406|NCT00990106|Secondary|Clinician-Administered PTSD Scale (CAPS) Total Score||Baseline, Weeks 7, 11 and 15||||||
81407|NCT00990106|Primary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.|Change from Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.||Percentage of responders||95% Confidence Interval|Number
81408|NCT00990106|Primary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.|Baseline to Week 15|||Scores on a Scale||Standard Error|Mean
81409|NCT00990106|Primary|Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15."|Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.||Scores on a Scale||Standard Error|Mean
81410|NCT00990093|Primary|Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.|"Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.~At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)"|14 days|Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome.||units on a scale||Standard Deviation|Mean
81411|NCT00989989|Secondary|Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||units on a scale||Standard Deviation|Mean
81412|NCT00989989|Secondary|Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Letters||Standard Deviation|Mean
81414|NCT00989989|Secondary|Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
81415|NCT00989989|Secondary|Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
81416|NCT00989989|Secondary|Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Percentage of participants|||Number
81417|NCT00989989|Secondary|Percent of Participants With Visual Acuity Above 73 Letters at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||percentage of participants|||Number
81418|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline|Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had sub-retinal fluid in any of the 6 sections of the study eye at baseline. Not applicable means there was no sub-retinal fluid at baseline.||percentage of participants|||Number
81419|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline|Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had intra-retinal cysts in any of the 6 sections of the study eye at baseline - not applicable means there was no intra-retinal cyst at baseline.||percentage of participants|||Number
81420|NCT00989989|Secondary|Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12|Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had Central Retinal Subfield Thickness value with signal strength ≥ 5 for Carl Zeiss Optical Coherence Tomography 3 system.||micrometers||Standard Deviation|Mean
81421|NCT00989989|Primary|Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.||Letters||Standard Deviation|Mean
81422|NCT00989950|Primary|Sleep Latency|Measure by daily subject sleep diary|9 weeks|All 26 subjects wore the patches for 9, 10, 11 and 12 hour wears. Results are based upon impact of patch wear time on parameter||minutes||95% Confidence Interval|Mean
81423|NCT00989911|Primary|Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months|Magnetic resonance imaging-derived aortic flow|3-6 months|||L/min||Standard Deviation|Mean
81424|NCT00989833|Secondary|Number of Participants With an Adverse Event During the Study||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Participants|||Number
81425|NCT00989833|Secondary|Diary Recording of Asthma Symptoms|Asthma symptoms during days with exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Percent of exercise days||Standard Deviation|Mean
81459|NCT00989586|Secondary|Access Pharmacokinetics Through Cmax|Evaluation of pharmacokinetics of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-dose|Cmax for patients dosed at 20 mg/kg||ug/ml||Standard Deviation|Mean
81426|NCT00989833|Secondary|Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)|Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.|Baseline e and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||units on a scale||Standard Deviation|Mean
81427|NCT00989833|Secondary|Use of as Needed Medication|Mean number of as needed inhalations taken before exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||number of inhalations per day||Standard Deviation|Mean
81428|NCT00989833|Secondary|Concentration of Exhaled Nitric Oxide||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||ppb||Standard Deviation|Mean
81429|NCT00989833|Secondary|Bronchial Responsiveness to Mannitol|Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)|Baseline and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||mg||Standard Deviation|Mean
81430|NCT00989833|Secondary|Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks|FEV1|Baseline and 3 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Percent change||Standard Deviation|Mean
81431|NCT00989833|Primary|Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks|FEV1|Baseline and Visit 6|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.||Percent change||Standard Deviation|Mean
81432|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|112 days|||microVolts||Standard Deviation|Mean
81433|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days|||microvolts||Standard Deviation|Mean
81434|NCT00989768|Primary|Horizontal Action Halo Diameter at 112 Days|The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|112 days|||centimeter||Standard Deviation|Mean
81435|NCT00989768|Primary|Horizontal Action Halo Diameter at 28 Days|The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|28 Days|||centimeter||Standard Deviation|Mean
81436|NCT00989664|Secondary|Number of Participants With Hypothyroidism Prior to Therapy and After the Therapeutic Dose|Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the Iodine 131 on thyroid function. Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who were evaluable for thyroid function assessment were analyzed.||participants|||Number
81437|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. Grade 3/4 hematological toxicities: hemoglobin <8.0 g/dL; platelets <50,000 cells per millimeters (mm)^3; ANC <1000 cells per mm^3; WBC <2000 cells per mm^3.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population||participants|||Number
81438|NCT00989664|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|HAMA are human immunoglobulins with specificity for mouse immunoglobulins. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment. Time to HAMA positivity was calculated as the difference between the day on which HAMA positivity occurred and the first dosimetric dose administration day.|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were analyzed.||days||Full Range|Median
81448|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or Grade 4 AEs were analyzed.||participants|||Number
81497|NCT00989157|Primary|AUCo-inf,|Area under the plasma concentration time curve|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||ng h/mL||Standard Deviation|Mean
81439|NCT00989664|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Before Receiving the Dosimetric Dose) But Positive or Negative After Receiving the Dosimetric Dose|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit."|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.||participants|||Number
81440|NCT00989664|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.||participants|||Number
81441|NCT00989664|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced any infection were analyzed.||participants|||Number
81442|NCT00989664|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced SAEs were analyzed.||participants|||Number
81443|NCT00989664|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious AEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.||participants|||Number
81444|NCT00989664|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE) Unrelated to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgment.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.||participants|||Number
81445|NCT00989664|Secondary|Number of Participants With the Indicated Time to Death From the Last Dose of Study Drug|Time to death from the last dose of study drug is the time period difference between when study drug treatment stopped and when death occurred.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.||participants|||Number
81446|NCT00989664|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.||participants|||Number
81447|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Related to Study Drug and Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or 4 AEs related to study drug were analyzed.||participants|||Number
81458|NCT00989586|Secondary|Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA)|Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA).|up to 36 weeks|HAHA titres were assayed for patients in Phase I and Phase II||patients|||Number
81449|NCT00989664|Secondary|Number of Participants With the Indicated Adverse Events (AE) Related to Study Drug Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced any AE related to study drug were analyzed.||participants|||Number
81450|NCT00989664|Secondary|Number of Participants With Responses of CR, CCR, CR+CCR, and PR Following TST and I 131 TST and Following the LQCR, as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
81451|NCT00989664|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
81452|NCT00989664|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced treatment failure were analyzed.||months||95% Confidence Interval|Median
81453|NCT00989664|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced disease progression or died were analyzed.||months||95% Confidence Interval|Median
81454|NCT00989664|Secondary|Number of Participants With Any Confirmed Response (CR, CCR, or PR), Confirmed CR, Confirmed CCR, Confirmed CR+CCR, and Confirmed PR, as Assessed by Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with CR, CCR , or PR. A confirmed response (CR/CCR/PR) had to be confirmed by a consecutive response (>=28 days [ 4 weeks] later) that was the same or better. Individual confirmed response data only counts that response confirmed by the same response; thus, not all possible combinations are represented.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
81455|NCT00989664|Secondary|Number of Participants With Any Uncofirmed Response (CR, Clinical Complete Response [CCR], or PR), CR, CCR, CR+CCR, and PR), as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.||participants|||Number
81456|NCT00989664|Primary|Duration of Response for Par. Receiving TST and I 131 TST With a Response >=30 Days Versus the Number of Par. With a Response >=30 Days After Their LQCR, as Assessed by the MIRROR Panel|Duration of response is defined as the time from the first documented response (for par. with complete response, complete response unconfirmed, or partial response) until disease progression (DP). DP is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants with complete response, complete response unconfirmed, or partial response were analyzed.||months||95% Confidence Interval|Median
81457|NCT00989664|Primary|Number of Participants (Par.) Receiving TST and I 131 TST With a Response >=30 Days Versus Par. With a Response >=30 Days After Their Last Qualifying Chemotherapy Regimen (LQCR), Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Par. with response are those with complete response (CR; complete resolution of all disease-related radiological abnormalities and the disappearance of all signs/symptoms related to disease), complete response unconfirmed (CRu; meets characteristics of CR, except the nodal size hasn’t regressed sufficiently, or there is indeterminate bone marrow), or partial response (PR; >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Participants' LQCR was used as a comparator for subsequent treatment with Iodine I 131TST.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population||participants|||Number
81460|NCT00989586|Secondary|Access Pharmacokinetics Through AUC0–∞ (Area Under Curve)|Evaluation of pharmacokinetics (Pk) of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-does|AUC0–∞ for patients dosed at 20 mg/kg||d*ug/ml||Standard Deviation|Mean
81461|NCT00989586|Secondary|Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry|Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 at screening, after induction, and prior to the start of therapy on day 1 week 12, day 1 week 28, and then every 4 months for one year.|up to 1 year|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.|||||
81462|NCT00989586|Secondary|Fcγ-receptor Polymorphism Response to Treatment|The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes.|up to 2 years|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.|||||
81463|NCT00989586|Secondary|Progression-free Survival (PFS)|Progression is defined using International Response Criteria (Cheson JCO 2007), as a >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions.|up to 2 years|||months||95% Confidence Interval|Median
81464|NCT00989586|Primary|Overall Objective Response Rate|Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR.|Up to 2 years|||percent of patients|||Number
81465|NCT00989586|Primary|Maximum Tolerated Dose (MTD)for Phase I Patients|Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated|up to 2 years|||mg/kg|||Number
81466|NCT00989586|Primary|Dose Limiting Toxicity (DLT) for Phase I Patients|Dose-limiting toxicity was assessed during induction therapy for phase I.|up to 2 years|||patients|||Number
81467|NCT00989235|Secondary|Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment|A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region'|After 12 months of treatment|Number of participants analyzed= Number of participants with available immunogenicity measurements||participants|||Number
81468|NCT00989235|Secondary|Clinically Significant Changes in Vital Signs and Physical Findings|Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events.||participants|||Number
81469|NCT00989235|Secondary|Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment|Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(*)Lymphocytes(c/uL):Low<.750x10^3,High>7.50x10^3.(*)Eosinophils:>.750x10^3 c/uL.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure||percentage of participants|||Number
81470|NCT00989235|Secondary|Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity|A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
81471|NCT00989235|Secondary|Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
81472|NCT00989235|Secondary|Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
81473|NCT00989235|Secondary|Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment|All neoplasms were assessed by medical review as to whether or not the event was malignant.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
81474|NCT00989235|Secondary|Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
81475|NCT00989235|Secondary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.||percentage of participants|||Number
81476|NCT00989235|Secondary|Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment||Day 701 of the main study; sub-study Days 1, 85, 169, 253|Number of participants analyzed= number of participants randomized; n =randomized participants with measurement at given time point. For the Day 701 measure, one apparent outlier sample was deleted..||ng/mL||Standard Deviation|Mean
81477|NCT00989235|Secondary|Percentage of Participants Who Lost Remission Status|Loss of remission is defined as DAS 28 CRP >=2.6.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
81478|NCT00989235|Secondary|Percentage of Participants Who Modified Therapy During Double-Blind Treatment|Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
81479|NCT00989235|Secondary|Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
81480|NCT00989235|Primary|Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)|An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month.||Percentage of Events|||Number
81481|NCT00989235|Secondary|Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids|A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants|||Number
81482|NCT00989235|Secondary|Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment|Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
81483|NCT00989235|Secondary|Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)|DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.||percentage of participants||95% Confidence Interval|Number
81484|NCT00989235|Secondary|Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point.||units on a scale||Standard Error|Mean
81485|NCT00989235|Secondary|Mean Time-Matched Baseline DAS28 CRP Scores|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline|Number of participants analyzed=number of participants randomized; n=All treated participants with available DAS28 CRP scores at that time point. Mean time-matched baseline values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
81486|NCT00989235|Secondary|Number of Participants Experiencing Disease Relapse|Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score >= 3.2 at 2 consecutive visits.|After 12 Months of treatment|Number of participants analyzed=number randomized.||Participants|||Number
81487|NCT00989196|Secondary|Immunogenicity (Number of Patients That Developed an Inhibitor During the Course of the Study)|Inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) at study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for some patients who may finish the study before they achieve 50 EDs), with human-cl rhFVIII (i.e. at the study completion visit).|study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for|||participants|||Number
81488|NCT00989196|Secondary|Efficacy of On-demand Treatment of Bleeding Episodes|"After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 – 12 hours after an infusion requiring up to 2 infusions for complete resolution.~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.~The assessment was made at the end of a BE in case more than one infusion was needed."|From 1st treatment after PK cycle 2 until study end.|||percentage of bleeding episodes|Participants||Number
81489|NCT00989196|Secondary|Clearance (CL) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||mL/h/kg||Standard Deviation|Mean
81490|NCT00989196|Secondary|Volume of Distribution at Steady State (Vss) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||mL/kg||Standard Deviation|Mean
81491|NCT00989196|Secondary|Mean Residence Time (MRT) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||hours||Standard Deviation|Mean
81492|NCT00989196|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||hours||Standard Deviation|Mean
81493|NCT00989196|Secondary|Maximum Plasma Concentration (Cmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||IU/mL||Standard Deviation|Mean
81494|NCT00989196|Secondary|Pharmacokinetic Parameter: Invivo Half-life (T1/2) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||hours||Standard Deviation|Mean
81495|NCT00989196|Primary|The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.|||h IU/mL (IU/kg)||Standard Deviation|Mean
81496|NCT00989157|Primary|T1/2|Half life|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||hours||Standard Deviation|Mean
81498|NCT00989157|Primary|Tmax|Time to maximum plasma concentration|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72|||Hours||Standard Deviation|Mean
81501|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During Weeks 5-12|The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).||days||Standard Deviation|Mean
81502|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During Weeks 5-12|The number of standard units of RBCs transfused during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of week 5 (study day 29).||units of red blood cells||Standard Deviation|Mean
81503|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12|The number of participants with at least one RBC transfusion during weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).||Participants|||Number
81504|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During the Test Period|The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.||days||Standard Deviation|Mean
81505|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During the Test Period|The average number of standard units of red blood cells transfused during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.||units of red blood cells||Standard Deviation|Mean
81506|NCT00989092|Primary|Number of Hospitalizations During the Test Period|Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.||hospitalizations||Standard Deviation|Mean
81507|NCT00989092|Primary|Days of Hospitalization During the Test Period|Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.||days||Standard Deviation|Mean
81508|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period|Number of participants with at least one RBC transfusion during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm with available data.||Participants|||Number
81509|NCT00989092|Secondary|Change From Baseline in Hemoglobin Level|The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion. LVCF imputation was used.||g/dL||Standard Deviation|Mean
81510|NCT00989092|Secondary|Hematopoietic Response During the Test Period|The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.||Participants|||Number
81511|NCT00989092|Secondary|Hemoglobin Response During the Test Period|The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.||Participants|||Number
81512|NCT00989092|Secondary|Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13|The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Participants also needed to have completed the baseline and at least 1 post-baseline FACT-Fatigue questionaire. Last Value Carried Forward (LVCF) imputation used.||units on a scale||Standard Deviation|Mean
81513|NCT00989092|Secondary|Total Hospital Costs During the Test Period|The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and were included in the hospital bill database. Participants who were not hospitalized had a cost of $0 imputed.||dollars||Standard Deviation|Mean
81514|NCT00989092|Primary|Number of Participants Hospitalized During the Test Period|Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.|Weeks 1- 12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.||Participants|||Number
81515|NCT00989014|Primary|Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.||Baseline and every hour for 12 hours following application|||participants|||Number
81516|NCT00988884|Secondary|Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™|Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves >50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||Titer||95% Confidence Interval|Geometric Mean
81517|NCT00988884|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
81518|NCT00988884|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up||Percentage of participants|||Number
81519|NCT00988884|Primary|Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination.|Day 1 through Day 5 following Day 1 or Month 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs||Percentage of participants|||Number
81520|NCT00988884|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs||Percentage of participants|||Number
81521|NCT00988884|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||ELU/mL||Full Range|Geometric Mean
81522|NCT00988884|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of >=0.1 IU/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
81523|NCT00988884|Primary|Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups|For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving >50% killing in 60 minutes.|Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint||Percentage of participants|||Number
81524|NCT00988884|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint||milli Merck Units/mL||Full Range|Geometric Mean
84940|NCT00956839|Secondary|Serum Total Calcium|Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months|0, 1, 3, 6 months post intervention|at time points 0, 1, 3 and 6 months||mg/dL||Standard Deviation|Mean
81525|NCT00988832|Primary|Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of diagnostic tests conducted during outpatient consultations were calculated as per the 2008-2009 NHS Reference Costs. Costs for diagnostic tests during hospitalizations and A&E visits were incorporated into cost analyses for those categories and are not included here.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81526|NCT00988832|Primary|Mean Cost Per Participant for Crohns-related Medications|Costs of biologics were calculated by multiplying the number of vials of drug used per participant by the 2009 British National Formulary (BNF) cost per vial. Costs of other drugs with ≥10 prescriptions were calculated by multiplying the 2009 BNF daily cost of the standard/most-prescribed dose of the most-prescribed drug (reference drug) in each drug group (Anatomical Therapeutic Classification [ATC] Level 4) by the length of treatment. Costs for drugs in drug groups with ≤9 prescriptions were calculated using the average cost of all Crohns medications multiplied by the length of treatment.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81527|NCT00988832|Primary|Mean Cost Per Participant of Accident and Emergency (A&E) Visits|Costs for visits to A&E without admission. Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease as per the 2009 Healthcare Resource Group (HRG) descriptors.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81528|NCT00988832|Primary|Mean Cost Per Participant for All Hospitalizations|"Costs for all hospitalizations, including costs associated with elective~and emergency (non-elective) admissions as well as outpatient procedures."|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81529|NCT00988832|Primary|Mean Cost Per Participant for Admissions for Day Case Surgery|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of day case (outpatient) surgeries were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for any surgeries that did not require the participant to stay overnight in the hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81530|NCT00988832|Primary|Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of non-elective or emergency inpatient admissions were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for unplanned hospital admissions due to emergency surgical procedures and unplanned consultations due to complications.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81531|NCT00988832|Primary|Mean Cost Per Participant of Elective Surgical Procedures|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of elective surgical procedures were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for elective surgeries that required participants to be admitted into a hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81532|NCT00988832|Primary|Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of outpatient consultations are based on the 2009 Unit Cost of Health and Social Care published by the Personal Social Service Research Unit. Consultations with gastroenterologists, gastric/gastrointestinal surgeons, radiologists, nurses/Inflammatory Bowel Disease nurses, dieticians/nutrition specialists, psychologists/psychiatrists, pharmacists, and occupational therapists are included in the analysis.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab|||Pounds sterling per participant||Standard Deviation|Mean
81533|NCT00988637|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4|Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.|Baseline to Week 4|Safety||participants|||Number
81534|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I Would Use This Treatment Program Again if Recommended by the Dermatologist at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I would use this treatment program again if recommended by the dermatologist at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)||participants|||Number
81535|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With the Results of This Treatment Program at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am satisfied with the results of this treatment program at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)||participants|||Number
81536|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With my Appearance at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am Satisfied with my Appearance at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)||participants|||Number
81550|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent to treat population.||Percent of Participants|||Number
81537|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question The Treatment Program Was Easy to Follow at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question The treatment program was easy to follow at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Baseline and Week 4|ITT (Intent to Treat)||participants|||Number
81538|NCT00988637|Secondary|Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4|Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.|Baseline to Week 4|ITT (Intent to Treat)||Units on a scale||Standard Deviation|Mean
81539|NCT00988637|Secondary|Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4|Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||Percent change||Standard Deviation|Median
81540|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||participants|||Number
81541|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||participants|||Number
81542|NCT00988637|Secondary|Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4|Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)||participants|||Number
81543|NCT00988637|Secondary|Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4|Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)||participants|||Number
81544|NCT00988637|Secondary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to week 2|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
81545|NCT00988637|Primary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
81546|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||hour||Standard Deviation|Mean
81547|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||ng/mL||Standard Deviation|Mean
81548|NCT00988533|Secondary|Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.||mg/dL||Standard Deviation|Mean
81549|NCT00988533|Secondary|Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.||U/L||Standard Deviation|Mean
84941|NCT00956839|Primary|Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml|Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml|6 months post intervention|Intention to treat analysis||percentage of patients||95% Confidence Interval|Number
81551|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent-to-treat population.||Percent of Participants|||Number
81552|NCT00988533|Secondary|Number of Participants Reporting Adverse Events Following Ivermectin Treatment|Adverse events were assessed at each visit and during the follow up phone call on Day 28.|Day 1 up Day 28 post-application|Adverse events were assessed in the intent-to-treat population.||Participants|||Number
81553|NCT00988533|Primary|Summary of Pharmacokinetic Parameters Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||ng/h/mL||Standard Deviation|Mean
81554|NCT00988533|Primary|Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.||ng/mL||Standard Deviation|Mean
81555|NCT00988429|Secondary|Proportion of Responders|Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.|Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||percentage of participants||95% Confidence Interval|Number
81556|NCT00988429|Primary|Seizure Frequency Over the 12-week Maintenance Period.||12-week maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.||Nº Standardized Seizures by 4 weeks||Standard Error|Least Squares Mean
81557|NCT00988351|Secondary|Treatment Pressure (Level of CPAP or 90th Percentile APAP)|The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.|6 weeks clinic|participants using PAP at the 6 weeks clinic visit||cm H2O||Standard Deviation|Mean
81558|NCT00988351|Secondary|Residual Apnea-hypopnea Index|The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.|over first 6 weeks of treatment|participants using PAP at clinic visit (>= 1/2 hour of nightly use)||events (apneas+hypopneas)/hour||Standard Deviation|Mean
81559|NCT00988351|Secondary|Change in Functional Outcomes of Sleep Questionnaire|The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.|6 weeks at clinic|Using PAP 1/2 hour or more nightly||units on a scale||Standard Deviation|Mean
81560|NCT00988351|Secondary|Change in Epworth Sleepiness Scale|Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.|6 weeks after starting treatment|||units on a scale||Standard Deviation|Mean
81561|NCT00988351|Primary|Positive Airway Pressure Adherence (Nightly Use of Treatment)|average nightly hours of using positive airway pressure (including 0 for nights not used)|6 weeks after starting treatment|patients using cpap or apap at clinic visit||hours||Standard Deviation|Mean
81562|NCT00988247|Secondary|Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 52 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 52|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
81563|NCT00988247|Secondary|Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 30 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 30|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
81634|NCT00988091|Secondary|Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26|Adjusted mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm = no pain, stiffness and difficulty; 100 mm = extreme pain, stiffness and difficulty. Change from baseline calculated as: Week 26 minus baseline.|Day 0 (baseline), week 26|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
81564|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
81565|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
81566|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
81567|NCT00988247|Primary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
81568|NCT00988221|Secondary|Height Standard Deviation Score at Baseline, Week 52, and Week 104|The height Standard Deviation Score was calculated using the following formula: (Observed height - median of the reference population)/standard deviation of the reference population. The reference population was defined as that of the same sex and age to the nearest completed year and month using the World Health Organization norms. A negative score indicates less height than the reference population.|Baseline to Week 104|Growth population: All participants who received at least 1 dose of tocilizumab but who did not take the growth hormone somatotropin.||Standard deviation score||Standard Deviation|Mean
81569|NCT00988221|Secondary|Methotrexate Dose at Baseline, Week 52, and Week 104|Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.||mg/m^2/week||Standard Deviation|Mean
81570|NCT00988221|Secondary|Oral Corticosteroid Dose at Baseline, Week 52, and Week 104|Due to the different types of corticosteroid medications available, the prednisone equivalent was used in the calculation of the oral corticosteroid dose. Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All patients randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.||mg/kg/day||Standard Deviation|Mean
81571|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.||Percent of patients|||Number
81572|NCT00988221|Secondary|Percent of Patients in Clinical Remission From Week 40 to 104|A patient was in clinical remission if they had inactive disease at all visits in the 6 months prior to and including the visit assessment day. A patient was judged to have inactive disease if all of the following criteria were met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 40 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.||Percent of patients|||Number
81573|NCT00988221|Secondary|Percent of Patients With Inactive Disease From Week 16 to Week 104|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 16 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.||Percent of patients|||Number
81574|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Units on a scale||Standard Deviation|Mean
81575|NCT00988221|Secondary|C-reactive Protein Levels From Baseline to Week 104|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.||mg/L||Standard Deviation|Mean
81576|NCT00988221|Secondary|Percent of Patients With a Minimally Important Improvement in the Children’s Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104|The CHAQ-DI consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A minimally important improvement is an improvement ≥ 0.13 over Baseline. Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.||Percent of patients|||Number
81577|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at Week 104|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Percent change||Standard Deviation|Mean
81578|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at Week 104|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Percent change||Standard Deviation|Mean
81579|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at Week 104|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.||Percent change||Standard Deviation|Mean
81653|NCT00987935|Secondary|Time to Progression (TTP) in Phase II (Follow-up Analyses)|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until disease progression or data cut-off (16 Jul 2014); Up to 171 weeks|Treated set, Only phase II participants||months||Inter-Quartile Range|Median
81580|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at Week 104|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.||Percent change||Standard Deviation|Mean
81581|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at Week 104|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.||Percent change||Standard Deviation|Mean
81582|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at Week 104|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.||Percent change||Standard Deviation|Mean
81583|NCT00988221|Secondary|Change From Baseline in the Juvenile Arthritis Disease Activity Score-71 (JADAS-71) at Week 104|The JADAS-71 is composed of 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range = 0-10, left end of the line = arthritis inactive, ie, symptom-free and no arthritis symptoms; right end = arthritis very active), patient/parent global assessment of overall well-being on a VAS (range = 0-10, left end of the line = very well, ie, symptom-free and no arthritis disease activity; right end = very poor, ie, maximum arthritis disease activity), normalized erythrocyte sedimentation rate (ESR) (range = 0-10, If ESR is ≤ 20 mm/h, set to 0. If ≥ 120 mm/h, set to 10 mm/h. If > 20 mm/h and < 120 mm/h, apply formula: [ESR − 20 mm/h]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). The JADAS-71 is the sum of the 4 component scores and ranges from 0-101. A higher score indicates more arthritis disease activity. A positive change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Only patients with non-missing data were included in the analysis.||Units on a scale||Standard Deviation|Mean
81584|NCT00988221|Secondary|Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Results are reported for the subgroups: Previous biologic treatment (yes/no), concomitant methotrexate use (yes/no), rheumatoid factor (positive/negative), concomitant oral corticosteroid use (yes/no). Last observation carried forward was applied to missing components at visits.|Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.||Percent of patients|||Number
81585|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Week 2 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study.||Percent of patients|||Number
81586|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part II of the Study (Week 40)|"A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10.~The statistical test is not significant due to a break in the hierarchical chain of significance testing."|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Percent of patients||95% Confidence Interval|Number
81587|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward (LOCF) imputation for missing values. The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids, and the pain visual analog scale score at Baseline. The adjusted means from the fitted model are presented.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
81588|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) at the End of Part II of the Study (Week 40)|The Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
81589|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part II of the Study (Week 40)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||mm/hour||Standard Deviation|Mean
81590|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part II of the Study (Week 40)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Joints||Standard Deviation|Mean
81591|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part II of the Study (Week 40)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Joints||Standard Deviation|Mean
81592|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
81593|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part II of the Study (Week 40)|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Units on a scale||Standard Deviation|Mean
81654|NCT00987935|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (28 Sep 2012); Up to 77 weeks|Treated set, only phase II participants.||months||Inter-Quartile Range|Median
81594|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Percent of patients||95% Confidence Interval|Number
81595|NCT00988221|Secondary|Percent of Patients With an Elevated White Blood Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|White blood cells were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
81596|NCT00988221|Secondary|Percent of Patients With an Elevated Platelet Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Platelets were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
81597|NCT00988221|Secondary|Percent of Patients With an Elevated Erythrocyte Sedimentation Rate at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
81598|NCT00988221|Secondary|Percent of Patients With an Elevated C-reactive Protein Concentration at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
81599|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part I of the Study (Week 16)|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
81600|NCT00988221|Secondary|Pain Visual Analogue Scale (VAS) Score at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Units on a scale||Standard Deviation|Mean
81601|NCT00988221|Secondary|Juvenile Arthritis Disease Activity Score (JADAS-27) at the End of Part I of the Study (Week 16)|The JADAS-27 is derived from the following components: Physician’s global assessment of disease activity on a 0-100 mm visual analog scale (VAS)/10, patient/parent’s global assessment of overall well-being on a 0-100 mm VAS/10, normalized erythrocyte sedimentation rate (ESR) (if ESR is ≤ 20 then set to 0, if ≥ 120 then set to 10, and if > 20 and < 120 then apply formula [ESR-20]/10), and number of joints (maximum of 27) with active arthritis (cervical spine, left/right elbow, left/right wrist, left/right MCP1-3, left/right PIP1-5, left/right hips, left/right knee and left/right ankle). The scores for the first 3 components range from 0-10; the score for the final component ranges from 0-27. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Units on a scale||Standard Deviation|Mean
81602|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at the End of Part I of the Study (Week 16)|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
81603|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
81604|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part I of the Study (Week 16)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
81605|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part I of the Study (Week 16)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
81606|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
81607|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16)|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent change||Standard Deviation|Mean
81608|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.||Percent of patients|||Number
81609|NCT00988221|Primary|Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40)|JIA ACR30 flare is defined as a ≥ 30% worsening of 3 of 6 variables and no more than 1 of the remaining variables improving > 30%. The 6 variables are physician global assessment of disease activity (worsening of 20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (worsening of 20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew or who took escape medication are classified as flared. The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 16 through Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.||Percent of patients||95% Confidence Interval|Number
81610|NCT00988208|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and Severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|The maximum duration on study drug was 93 weeks, which includes the time from the first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut-off date of 13 January 2012|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).||participants|||Number
81622|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
81611|NCT00988208|Secondary|Objective Response Rate (ORR) of Measurable and/or Non-measurable Disease as Determined by Investigators According to RECIST Version 1.1 Criteria|Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response. RECIST Criteria 1.1 defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones|Day 1 to data cut-off 13 January 2012; maximum time on study approximately 26 months|Based on the ITT population||participants|||Number
81612|NCT00988208|Secondary|Progression-free Survival (PFS)|PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by RECIST Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan|Randomization until disease progression or death from any cause up to cut-off date of 13 Jan 2012; maximum time on study approximately 26 months|Based on the Intent to treat population (ITT)||Weeks||95% Confidence Interval|Median
81613|NCT00988208|Primary|Overall Survival (OS)|Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.|Randomization until death from any cause up to the cut-off date of 13 January 2012|Time to Death in Weeks; efficacy analysis was based on the Intention-to-Treat population (ITT), defined as all randomized patients irrespective of whether they received treatment or not.||weeks||95% Confidence Interval|Median
81614|NCT00988169|Primary|Radiographic Objective Response Rate|(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101|21 days after cycle one|||participants|||Number
81615|NCT00988156|Primary|Responder Rate|Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|baseline up to Visit 7|||participants|||Number
81616|NCT00988156|Primary|Change From Baseline in Seizure Frequency|Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|Baseline up to Visit 7|||seizures/month||Standard Deviation|Mean
81617|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).||Titers||95% Confidence Interval|Geometric Mean
81618|NCT00988143|Other Pre-specified|Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)."|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
81619|NCT00988143|Other Pre-specified|Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 up to 21 days post-vaccination|Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Participants|||Number
81620|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
81621|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 21 post-vaccination|Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.||Participants|||Number
81623|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)"|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.||Participants|||Number
81624|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population||Titers||95% Confidence Interval|Geometric Mean
81625|NCT00988143|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.|"Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.~(24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.~(Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.~Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity."|Day 0 up to 7 days post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.||Participants|||Number
81626|NCT00988117|Secondary|Pre-post Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
81627|NCT00988117|Primary|Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)|On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.|Baseline and 12 weeks|Data were missing for two of the patients on the CPT post-treatment due to a computer error.||milliseconds||Full Range|Median
81628|NCT00988117|Primary|Resting State Functional Activity Change From Baseline to 12 Weeks|Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.|Baseline and 12 weeks|All patients who completed the study were included.||z-score||Standard Deviation|Mean
81629|NCT00988091|Secondary|Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function (WOMAC Disability score) and global assessment (Patient Global Assessment Score) scales. Each of the individual scales was completed by the participant. A responder showed considerable improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. Response at Week 26 is compared to baseline.|Day 0 (baseline), week 26|Intent to treat population||percentage of participants|||Number
81630|NCT00988091|Secondary|Change From Baseline in Patient Global Assessment at Week 26|Participants were asked to mark along a 100mm visual analog scale (VAS) indicating the point best representing the severity of the knee pain that day. The left side of the VAS was 0=no pain and the right side was 100 = extreme pain. Change from baseline was calculated as Week 26 - Baseline.|Day 0 (baseline), Week 26|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
81631|NCT00988091|Secondary|Number of Tablets of Rescue Medication Used Between Visits|Acetaminophen (500-mg tablets) was provided to study participants as a rescue medication in case they needed a pain medication during the study. The mean number of tablets of rescue medication should have been summarized, however the data was not captured in a reliable way and is therefore not reported.|Day 1 to week 26|||tablets||Standard Deviation|Mean
81632|NCT00988091|Secondary|Subjective Patient Assessment of Treatment at Week 26|"At the end of the double-blind period (week 26), participants were asked: “Are you satisfied with the results of the injection? Answers could be: 1=dissatisfied; 2=slightly satisfied; 3=satisfied; or 4=very satisfied."|Week 26|Intent to treat population||units on a scale||Standard Deviation|Mean
81633|NCT00988091|Secondary|Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score. The percent of participants who showed a 20mm or greater improvement in the pain scores at week 26 compared to baseline are reported.|Day 0 (baseline), Week 26|Intent to treat population||percentage of participants|||Number
81635|NCT00988091|Primary|Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.|Day 0 (baseline) through Week 26|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
81636|NCT00988065|Other Pre-specified|Percentage of Participants With an Adverse Event Suggestive of a Dose-dependent Trend That Also Exceeds a Frequency Threshold Above 5% in Any Treatment Arm (Including Both Serious and Non-serious Adverse Events).|All adverse events from the study were reviewed for potential safety signals. The reported incidences suggestive of a dose-dependent trend and with a frequency threshold above 5% (including both serious and non-serious adverse events) are presented.|From first randomized dose (Day 8) up to 30 days after day of last randomized dose of study medication.|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants|||Number
81637|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review & determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.~The percentages of subjects who had adjudicated hypersensitivity (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) are presented for each of the 3 treatment arms for each dose."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated, per dose (i.e. who received the corresponding dose of randomized study medication).||percentage of participants|||Number
81638|NCT00988065|Secondary|The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine anaphylaxis according to the criteria put forth by the guidelines of the Brighton Collaboration Anaphylaxis Working Group as described by Rüggeberg et al. (Vaccine 2007; 25:5675-5684).~Level 1 represents the highest level of certainty of anaphylaxis and level 3 the lowest level of certainty.~The percentages of subjects who had adjudicated anaphylaxis according to the Rüggeberg Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants|||Number
81639|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine whether the subject's hypersensitivity sign/symptoms fulfilled the definition of anaphylaxis according to the criteria defined by the Symposium on the Definition and Management of Anaphylaxis as described by Sampson et al. (J Allergy Clin Immunol 2006; 117:391-7).~The percentages of subjects who had adjudicated anaphylaxis according to the Sampson Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants||95% Confidence Interval|Number
81640|NCT00988065|Primary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review and determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.~The percentages of subjects who had adjudicated hypersensitivity at any dose (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).||percentage of participants||95% Confidence Interval|Number
81641|NCT00987935|Secondary|fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib|"fe0-12,ss (fraction excreted in urine between 0 and 12 hours at steady state) for Nintedanib.~The reported value corresponds to the percentage of administered dose."|0 to 4 hours (h), 4 to 12 h, and 12 to 24 h after nintedanib|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||percentage||Geometric Coefficient of Variation|Geometric Mean
81642|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 glucuronide in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
81655|NCT00987935|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set (Patients from the dose escalation part that were not replaced for MTD determination)||mg|||Number
81656|NCT00987831|Post-Hoc|Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).||12 months|Only 40/41 entered patients completed the study by the definition of the endpoint which was flare.||days to flare||95% Confidence Interval|Median
81643|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
81644|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the Nintedanib in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
81645|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 Glucuronide (Metabolite of Nintedanib)|"AUC0-12,ss,norm of BIBF 1202 glucuronide (Metabolite of Nintedanib):~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
81646|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 (Metabolite of Nintedanib)|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of BIBF 1202 (metabolite of Nintedanib).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
81647|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of Nintedanib|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of Nintedanib~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
81648|NCT00987935|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, include only phase II participants||months||Inter-Quartile Range|Median
81649|NCT00987935|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.||months||Inter-Quartile Range|Median
81650|NCT00987935|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.~95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.||percentage of participants||95% Confidence Interval|Number
81651|NCT00987935|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).||participants|||Number
81652|NCT00987935|Secondary|Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.|Incidence and worst intensity (severity) of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)|Treated set||participants|||Number
81657|NCT00987831|Primary|Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline|Group A only: patients on immunosuppressive treatments had them withdrawn at baseline. All patients were allowed up to 160 mg depomedrol at baseline which could be repeated within two weeks up to a total of 4 shots maximum or until satisfactory improvement. Time to flare was calculated from baseline. moderate disease at baseline was defined as up to 3 BILAG B (moderate disease) organ scores, no BILAG A (severe disease) score and a SLEDAI </= 10. Severe disease required >3 BILAG B, OR at least one BILAG A OR SLEDAI > 10 or meeting criteria for a severe flare on the SELENA SLEDAI flare index. At baseline 25 patients with moderate disease. 16 patients had severe disease. Note: severe rash with A on BILAG is only SLEDAI=2, explaining some discrepancies in measures|12 months|This prespecified primary outcome was restricted to Group A only. This was an exploratory proof of concept study, not powered for the primary endpoint||days to flare||95% Confidence Interval|Median
81658|NCT00987727|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35|Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.||Number on a scale (score)||Standard Deviation|Mean
81659|NCT00987727|Primary|Change From Baseline in Global Ocular Staining Score at Day 35|Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.||Number on a scale (score)||Standard Deviation|Mean
81660|NCT00987623|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week’s wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent|1 week|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses.||Units on a Scale||Standard Deviation|Mean
81661|NCT00987558|Primary|Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14|||ng.h/mL||Standard Deviation|Mean
81662|NCT00987558|Primary|Simvastatin AUC0-t|"AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification~Simvastatin (Reference) ESL + Simvastatin (Test)"|Day 1 and Day 14|||ng.h/mL||Standard Deviation|Mean
81663|NCT00987558|Primary|Simvastatin Tmax (Time of Occurrence of Cmax)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14|||hours||Standard Deviation|Mean
81664|NCT00987558|Primary|Simvastatin Cmax (Maximum Plasma Concentration)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14|||ng/mL||Standard Deviation|Mean
81665|NCT00987467|Secondary|Corticosteroid Usage|Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period|12 months or longer|||Total number of flare-up episodes|||Number
81666|NCT00987467|Primary|Ocular Symptoms and Signs Total Composite Score|Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bublar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) evaluated on a 4 point scale of 0-3, with a minimum symptom score of 0- maximum 15, and sign score minimum 0-maximum 18, and total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of AKC.|Baseline and 8 weeks|||units on a scale||Full Range|Mean
81667|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.||meters||Standard Deviation|Mean
81668|NCT00987415|Secondary|Change in Quality of Life (KCCQ)|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.||units on a scale||Standard Deviation|Mean
81669|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.||meters||Standard Deviation|Mean
81670|NCT00987415|Secondary|Change in Quality of Life (KCCQ).|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.||units on a scale||Standard Deviation|Mean
81671|NCT00987415|Primary|A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.|CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved|24 Weeks|||participants|||Number
81672|NCT00987402|Primary|Surgical Site Infection|255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).|30 days post-operatively|||Participants|||Number
81675|NCT00987337|Secondary|Number of Participants With Laboratory Test Abnormalities by Severity|Number of participants with laboratory abnormalities by Division of Auto Immune Disease Syndrome (DAIDS) grade of 4; 3 or 4; 2, 3 or 4 was summarized. Abnormal laboratory values refers to a DAIDS grade greater than 0, where grade 1= mild, grade 2= moderate, grade 3= severe and grade 4 = potentially life-threatening.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
81676|NCT00987337|Secondary|Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||participants|||Number
81677|NCT00987337|Secondary|Number of Participants Who Discontinued Study Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||participants|||Number
81678|NCT00987337|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 72 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial. Treatment-related were events considered related to study drug by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||participants|||Number
81679|NCT00987337|Secondary|Number of Adverse Events (AEs) by Severity (All Causality)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). The most severe grade was used in case of multiple occurrences of the same event.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.||adverse events|||Number
81680|NCT00987337|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24|Plasma HCV RNA levels were measured using the Roche COBAS TaqMan assay (limit of detection: 15 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4, 12, 24|ITT population included all randomized participants who took at least 1 dose of study drug. LOCF method was used for imputing missing values for participants who did not discontinue from study. Final value was imputed as baseline for participants who discontinued before the time point of interest.||log10 IU/mL||Standard Deviation|Mean
81681|NCT00987337|Secondary|Percentage of Participants With Relapsed Response|A participant was considered to have relapsed response if the plasma HCV RNA levels were undetectable at end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) but detectable (>=15 IU/mL) during the off-treatment follow-up period up to Week 72. Overall percentage of participants with relapsed response was summarized.|Week 24 or Week 48 up to Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Participant with all the HCV RNA values missing during follow-up was imputed as having relapsed.||percentage of participants|||Number
81682|NCT00987337|Secondary|Percentage of Participants With Breakthrough Viremia|A participant was considered to have breakthrough viremia if there was a >2 log10 increase from nadir in HCV RNA concentration while on treatment or HCV RNA that became undetectable with treatment but then became persistently detectable (2 or more consecutive viral RNA measurements >1000 IU/mL) again during treatment. Overall percentage of participants with breakthrough viremia was summarized.|Baseline up to Week 48|ITT population included all randomized participants who took at least 1 dose of study drug.||percentage of participants|||Number
81683|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)|SVR24 was summarized only for those participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24 and all participants who received placebo for 48 weeks. A participant was considered to have achieved SVR24 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 for filibuvir participants who ended therapy at Week 24 and Week 48 for participants who received placebo) and 24 weeks following the completion of therapy (Week 48 for filibuvir participants who ended therapy at Week 24; Week 72 for placebo participants who ended therapy at Week 48).|24 weeks after completion of therapy (Week 48 or 72)|ITT population.N (number of participants analyzed)=evaluable participants for the measure. Missing HCV RNA value at EOT, all follow-up visits/at specified time point, all subsequent visits was considered not to have undetectable HCV RNA.Missing HCV RNA value at 24 weeks after EOT was imputed using value of subsequent follow-up visit, if available.||percentage of participants|||Number
88693|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
81684|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)|A participant was considered to have achieved SVR12 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) and 12 weeks following the completion of therapy (Week 36 for participants who ended therapy at Week 24; Week 60 for participants who ended therapy at Week 48). Overall percentage of participants with SVR12 was summarized.|12 weeks after completion of therapy (Week 36 or 60)|ITT population. Participant with missing HCV RNA values at end of treatment and all follow-up visits or at the specified time point and all subsequent visits was considered not to have undetectable HCV RNA. Missing HCV RNA value at 12 weeks following completion of therapy was imputed using value of subsequent follow-up visit, if available.||percentage of participants|||Number
81685|NCT00987337|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48|Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 12 (early viral response [EVR]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels <15 IU/mL.|Week 4, 12, 24, 48|ITT population included all randomized participants who took at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values for participants who did not discontinue from study. Participants who discontinued early from the study were considered not to have undetectable HCV RNA.||percentage of participants|||Number
81686|NCT00987337|Primary|Percentage of Participants With Sustained Viral Response (SVR) at Week 72|For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 24 (End of Treatment [EOT]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.|Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. If a participant had a missing value at Week 72, participant was considered a failure; if a participant had achieved SVR but died or discontinued within same time period, the participant was considered a success.||percentage of participants|||Number
81687|NCT00986999|Secondary|Change in hsCRP||3 months||||||
81688|NCT00986999|Secondary|Change in Total, HDL and LDL Cholesterol and Triglyceride Levels||3 months||||||
81689|NCT00986999|Secondary|Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing||3 months||||||
81690|NCT00986999|Secondary|Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels||3 months||||||
81691|NCT00986999|Secondary|Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes||3 months||||||
81692|NCT00986999|Primary|Change in Flow Mediated Dilatation (FMD) of the Brachial Artery||3 months|Not analyzed|||||
81693|NCT00986986|Secondary|HDL||12 weeks||||||
81694|NCT00986986|Primary|Flow Mediated Vasodilation|Flow mediated vasodilation is a marker of endothelial function|12 weeks|||percentage change in FMD||Inter-Quartile Range|Median
81695|NCT00986986|Secondary|High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12|"HDL, often referred to Good cholesterol levels, will be obtained in both arms. HDL is a marker of coronary heart disease."|Two time points (baseline and study week 12)|||mg/dl||Inter-Quartile Range|Median
81696|NCT00986986|Primary|Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12|Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.|Two time points (baseline and study week 12)|HIV infected patients with HDL-C < 40||percentage change in FMD||Inter-Quartile Range|Median
81697|NCT00986973|Secondary|Delis-Kaplan Executive Function System Verbal Fluency Subtest (D-KEFS)|The Delis–Kaplan Executive Function System (D-KEFS) is a neuropsychological test is used to measure a variety of verbal and nonverbal executive functions for both children and adults. Among the 9 subtests is the Verbal Fluency Test which measures letter fluency, category fluency, and category switching. Verbal Fluency Test. This subtest requires an individual to randomly generate words based upon given parameters (ex., as words beginning with the letter F) and the believed areas of executive function assessed are cognitive flexibility, response inhibition, and verbal fluency. Raw scores are calculated based on the number of correct answers, which are then converted to scaled scores with a mean of 10 and standard deviation of 3. Higher scaled score represents a higher level of executive verbal and nonverbal function.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all assessments.||units on a scale||Inter-Quartile Range|Median
81698|NCT00986973|Secondary|Wechsler Adult Intelligence Scale (WAIS-IV)-Digit Span|The Wechsler Adult Intelligence Scale (WAIS) is a test designed to measure intelligence in adults and older adolescents. It is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests comprising the Full Scale intelligence quotient (IQ). Contained within the WAIS is an assessment of digit-coding which consists of nine digit-symbol pairs followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured, with a higher score representative of a higher performance component of IQ/intelligence.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all WAIS-IV assessments.||Number of correct symbols||Inter-Quartile Range|Median
81708|NCT00986921|Primary|Time for Completion of Procedure|Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)|Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.|Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point.||Minutes||95% Confidence Interval|Mean
81699|NCT00986973|Secondary|Symbol-Digit Modalities Test (SMTD)|The symbol-digit modalities test (SDMT) was developed to identify individuals with neurological impairment. The SDMT requires individuals to identify nine different symbols corresponding to the numbers 1 through 9, and to practice writing the correct number under the corresponding symbol. Then they manually fill the blank space under each symbol with the corresponding number. A second oral administration is then completed. The participant is given a blank copy of the test and asked to state the correct number for each corresponding symbol. The participant is given 90 s to complete each of these administrations. A written and oral score is calculated by totaling the number of correct answers for each section. The score is the number of correctly coded items from 0-110 in 90 seconds, with a higher score representing less neurological impairment with respect to attention, scanning abilities and motor skills. The total raw score was used for purposes of this study.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all SMTD assessments.||units on a scale||Inter-Quartile Range|Median
81700|NCT00986973|Secondary|Paced Auditory Serial Addition Task (PASAT)|The Adapted Paced Auditory Serial Addition Task (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. For Rates #1 and #2, single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for PASAT is the total number of correct answers (out of 60, for a total possible score ranging from 0-60 with higher score preferred as it indicates higher auditory processing speed) for each trial. All scores are expressed as “z-scores” which are generated based on norms for 101 healthy adults, with separate norms for <12 years of education versus >12years of education. Using a reference population as a basis of comparison, the “z-score” is the number of standard deviations the score is above (positive) or below (negative) the mean of the reference population (zero). Possible z-scores lie on a continuous scale.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all PASATassessments.||units on a scale||Inter-Quartile Range|Median
81701|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to “T-scores” by means of age-based tables provided in test manual (T-scores can go from 0 – 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.||units on a scale||Inter-Quartile Range|Median
81702|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Total Recall|The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to “T-scores” by means of age-based tables provided in test manual (T-scores can go from 0 – 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.||units on a scale||Inter-Quartile Range|Median
81703|NCT00986973|Primary|Plasma Phenylalanine Level (mg/dl)|Plasma phenylalanine level (mg/dl) served as the primary means of evaluating brain glucose metabolism before and after sapropterin (KUVAN) therapy. Blood tests for phenylalanine levels (Phe) were collected before and 4 months after sapropterin (KUVAN) therapy. All subjects received KUVAN at a dose of 20/mg/kg/day for four months. The goal was to estimate the change in blood glucose metabolism after treatment with Sapropterin (if any), with the hypothesis that treatment would decrease plasma Phe levels.|Measurements were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 subject was withdrawn from the study due to poor compliance with KUVAN therapy.||mg/dl||Standard Deviation|Mean
81704|NCT00986960|Secondary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. in RRMS on Anterior Optic Pathway Pathology, as Measured by OCT and LCLA in Patients With RRMS.||1 year||||||
81705|NCT00986960|Primary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. on a Voxel-wise MTR Dynamic Mapping of the Lesions and NABT in Patients With RRMS|None. Study did not initiate recruitment or data collection.|1 year||||||
81706|NCT00986921|Secondary|Moderate or Severe Pain Overnight|Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)|Overnight|All participants are included||percentage of participants|||Number
81707|NCT00986921|Secondary|Assessment of Ease of Procedure by Operator|"The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult."|It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.|"All participants with a completed abortion procedure were rated by the operator as to ease of completing the procedure. The number of women in each group having an abortion procedure rated easy or very easy is tabulated"||percentage of participants|||Number
81728|NCT00986544|Primary|Number of Participants With Subhepatic Collection at Ultrasonographic Examination|An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.|first postoperative day|An intention to treat (ITT) analysis was performed.||Participants|||Number
81709|NCT00986856|Secondary|The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).|Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.|EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)||Units on a scale||Standard Error|Mean
81710|NCT00986856|Secondary|Number of Patients With Bacteriological Success at EOT||EOT: Visit at day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline||Participants|||Number
81711|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation||Participants|||Number
81712|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 2||Visit 2: Day 4|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline||Participants|||Number
81713|NCT00986856|Secondary|Number of Patients With Clinical Success at EOT||EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)||Participants|||Number
81714|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation||Participants|||Number
81715|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 2||Visit 2: Day 4|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)||Participants|||Number
81716|NCT00986856|Primary|Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).||EOT: Visit at Day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline||Participants|||Number
81717|NCT00986674|Secondary|Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients who have response data. 3 patients on arm I and 1 patient on arm III had unknown/missing tumor response and were excluded from the analysis||percentage of participants||95% Confidence Interval|Number
81718|NCT00986674|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients||months||95% Confidence Interval|Median
81719|NCT00986674|Primary|Progression Free Survival|"Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .~All eligible and treated patients were included in the analysis."|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients||months||95% Confidence Interval|Median
81720|NCT00986583|Secondary|Fasciculation|The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities.|postoperative|||participants|||Number
81721|NCT00986583|Secondary|Duration of Succinylcholine Block|Time required to reach maximum block by succinylcholine after succinylcholine administration.|intraoperative: from succinylcholine administration|||minute||Inter-Quartile Range|Median
81722|NCT00986583|Secondary|Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively|Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively|2 and 24 hours postoperatively|Two patients in the nonstatin group had missing CK value at 2 hour||units/l||Inter-Quartile Range|Median
81723|NCT00986583|Secondary|Serum Potassium Concentration||At 5 and 20 min after succinylcholine|Two patients in non-statin group had missing value at 20 minute.||mEq/l||Inter-Quartile Range|Median
81724|NCT00986583|Secondary|Muscle Pain|"verbal rating scale score and the pain score both at 2 and 24 hours postoperatively.~The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable).~The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain."|2 and 24 hours postoperatively|||participants|||Number
81725|NCT00986583|Primary|Plasma Myoglobin Concentration||induction, 5 minutes after administration, 20 minutes and 24 hours post operatively|||ug/l||Inter-Quartile Range|Median
81726|NCT00986570|Primary|Treatment Success|Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.|Baseline (pre-treatment) and Visit 3 (Day 15)|||% of participants||95% Confidence Interval|Number
81727|NCT00986544|Secondary|Number of Participants With Postoperative Complications||1 month|Intention to treat analysis||participants|||Number
81781|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement|Patients who have global impression for improvement for each dosing.|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression.||participants|||Number
81729|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Positive Score.|Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|||Units on a scale||Standard Error|Least Squares Mean
81730|NCT00986479|Secondary|Visual Analogue Scale (VAS) Anxious Score.|"The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between “extreme sad” (0-mm) and “extreme happy (100-mm), with a median “normal” point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81731|NCT00986479|Secondary|Young Mania Rating Scale (YMRS) Score.|Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81732|NCT00986479|Secondary|Beck Depression Inventory (BDI) Score.|Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81733|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Score.|"The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126.~18 is considered to be the best outcome, 126 the worst."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81734|NCT00986479|Secondary|Clinician-Administered Dissociative States Scale (CADSS) Score.|Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81735|NCT00986479|Secondary|Visual Analogue Scale (VAS) Depressed Score|"The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between “extreme sad” (0-mm) and “extreme happy (100-mm), with a median “normal” point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.||Scores on a scale||Standard Error|Least Squares Mean
81736|NCT00986479|Secondary|Hamilton Depression Rating Scale-17 Item (HDRS) Total Score|Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81737|NCT00986479|Secondary|Hamilton Anxiety Rating Scale (HAM-A) Total Score.|Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.|60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|||Units on a scale||Standard Error|Least Squares Mean
81738|NCT00986479|Secondary|Scale for Suicide Ideation (SSI) Total Score.|Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81739|NCT00986479|Secondary|The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).|Response defined as a >= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Participants|||Number
81782|NCT00986245|Secondary|Adverse Events|Patients who have adverse events|After 8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||participants|||Number
81740|NCT00986479|Secondary|The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).|Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score <10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Participants|||Number
81741|NCT00986479|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.||Units on a scale||Standard Error|Least Squares Mean
81742|NCT00986453|Secondary|Dissection Performance|Amount of tissue (g) removed over time (min)|Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||g/min|Participants|Standard Deviation|Mean
81743|NCT00986453|Secondary|Amount of Tissue Removed||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||g|Participants|Standard Deviation|Mean
81744|NCT00986453|Secondary|Operative Time||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||minutes|Participants|Standard Deviation|Mean
81745|NCT00986453|Secondary|Estimated Blood Loss||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||mL|Participants|Standard Deviation|Mean
81746|NCT00986453|Primary|Postoperative Pain|"The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.~Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days."|0 to 10 days postoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.||units on a scale|Participants|Standard Deviation|Mean
81747|NCT00986427|Secondary|Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)|Number of subjects achieving improvement in the PGIA. The investigator assessed the two target fingernails with a rating of Excellent, Good, Fair, No Improvement or Worse based on the comparison between the nails at the current visit and high-resolution photographs of the nails taken at baseline. An improvement was a score of Excellent/Good/Fair vs. No Improvement/Worse.|Week 24|||participants|||Number
81748|NCT00986427|Secondary|Growth of the Treated and Untreated Nail in the Previous 4 Weeks|Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.|Week 24|||Millimeters (mm)||Standard Deviation|Mean
81749|NCT00986427|Secondary|Change From Baseline in Quality of Life (QOL) Related to Nail Disease|"Change from baseline in quality of life as measured at week 24 by the subject satisfaction Questionnaire question: Overall, how satisfied are you with your nails? Responses ranged from 1 (very satisfied) to 5 (very unsatisfied). A negative number changed from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24|||scores on a scale||Standard Deviation|Mean
81750|NCT00986427|Primary|Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2|"Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24.~The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24|||scores on a scale||Standard Deviation|Mean
81751|NCT00986401|Secondary|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® alone and in combination with Glucophage®. Plasma is the fluid portion of the blood in which the cells are suspended.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
81752|NCT00986401|Primary|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
81753|NCT00986362|Primary|Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).|Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.|Beginning of vitrectomy or after application of suction|Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups||percentage of eyes|Participants||Number
81754|NCT00986349|Other Pre-specified|Fasting Plasma Glucose Over Time for All Subjects||Baseline to 12 months post Device Explant|Subjects with a Successful Device Implant Procedure||mmol/L||Full Range|Median
81755|NCT00986349|Secondary|Total Weight Change (kg) at Week 52 Compared to Baseline Weight||Baseline to 52 weeks|||kg||Standard Deviation|Mean
81756|NCT00986349|Primary|Change in Anti-diabetes Medications|Medications were classified as “increased” if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as “decreased” if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as “not assessable.”|Baseline to 52 weeks|||Participants|||Count of Participants
81757|NCT00986349|Primary|Assessment of Glycemic Control (HbA1c) Over Time|HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12|Baseline to 12 Months with device implanted|20 subjects with a successfully implanted device were analyzed at Baseline. 1 subject removed at day 75 due to non-compliance with attending required visits. 1 subject removed at 175 due to device rotation, 2 subjects removed at day 203 and 313 due to abdominal pain AE||HbA1c %||Full Range|Median
81758|NCT00986258|Secondary|painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
81759|NCT00986258|Secondary|painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
81760|NCT00986258|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
81761|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone|Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 8 participants with previous hydromorphone treatment.||Ratio|||Number
81762|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Morphine|Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 14 participants with previous morphine treatment.||Ratio|||Number
81763|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Fentanyl|Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 22 participants with previous transdermal fentanyl treatment.||Ratio|||Number
81764|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 24 participants with previous buprenorphine treatment.||Ratio|||Number
81765|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 35 participants with previous oxycodone treatment.||Ratio|||Number
81766|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.~The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
81767|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 6|"Intention to treat (ITT).~For the sub-scores Overall Score and Pressing Pain there were only 60 participants with data available at Visit 6."||units on a scale||Standard Deviation|Mean
81768|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|Baseline|"Intention to treat (ITT).~For the sub-scores Overall Score and Pressing Pain there were only 69 participants with data available at baseline."||units on a scale||Standard Deviation|Mean
81769|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 Weeks)|"Intention to Treat (ITT).~For the sub-scores Role Emotional and Role Physical, there were only 91 participants with data available for the change of these sub-scores from baseline to visit 12."||units on a scale||Standard Deviation|Mean
81770|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 Weeks)|"Intention to treat (ITT).~For the sub-scores Role Emotional and Role Physical there were 98 participants, for sub-scores Physical Functioning, Vitality and Mental Health there were 99 participants, for sub-score General Health there were 100 participants with data available for the change of these sub-scores from baseline to visit 6."||units on a scale||Standard Deviation|Mean
81771|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT)||participants|||Number
81772|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT)||participants|||Number
81773|NCT00986258|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
81774|NCT00986258|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
81775|NCT00986258|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat||units on a scale||Standard Deviation|Mean
81776|NCT00986258|Primary|Number of Participants That Responded to Treatment|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment as with their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).||participants|||Number
81777|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Dyskinesia|Patients who have Global Impression for Improvement to Severity of Dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia severity.||participants|||Number
81778|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Dyskinesia|Patients who have global impression for improvement to duration of dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia duration.||participants|||Number
81779|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation|Patients who have global impression for improvement to severity of motor fluctuation compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation severity.||participants|||Number
81780|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation|Patients who have global impression for improvement to duration of motor fluctuation|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation duration.||participants|||Number
81783|NCT00986245|Secondary|Compliance|Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||percentage of used medication||Standard Deviation|Mean
81784|NCT00986245|Secondary|Epworth Sleep Scale|"Epworth sleep scale after 8 weeks in each arm or at last visit for early completion.~Range: 0~24 Higher values represent worse daytime-sleepiness."|8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
81785|NCT00986245|Secondary|Early Morning Off Symptoms|"Sleep questionnaire 3 for early morning off symptoms Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
81786|NCT00986245|Secondary|Nocturnal Off-symptoms|"Sleep questionnaire 2 for Nocturnal off-symptoms Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
81787|NCT00986245|Secondary|Overall Quality of Sleep|"Sleep questionnaire 1 for Overall quality of sleep Visual analogue scale: 0~10 Higher values represent worse overall sleep quality."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
81788|NCT00986245|Secondary|Hoehn and Yahr Stage|Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0~5 Higher values represent more severe parkinsonism|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||Scores on a scale||Standard Deviation|Mean
81789|NCT00986245|Secondary|Unified Parkinson's Disease Rating Scale, Part 3|"Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion.~UPDRS part 3 is motor scale for parkinson's disease. Range: 0~108 Higher values represent more severe motor symptoms of parkinsonism."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or Twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.||units on a scale||Standard Deviation|Mean
81790|NCT00986245|Primary|Patient Preference|Patient preference between once-daily and twice-daily regimen|After 16 weeks or at last visit for early completion|"Primary outcome measure was the preference of the subjects between once-daily versus twice-daily of RPR at the completion or at early completion after crossover.~61 of participants completing period with study intervention."||participants|||Number
81791|NCT00986232|Secondary|Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
81792|NCT00986232|Secondary|Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
81793|NCT00986232|Secondary|Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
81794|NCT00986232|Secondary|Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
81795|NCT00986232|Secondary|Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)|Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination Visit 1 or Visit 2|All participants with follow-up for safety were included in the analysis.||Participants|||Number
81796|NCT00986232|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
81797|NCT00986232|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL|Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
81798|NCT00986232|Secondary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL|Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
81799|NCT00986232|Primary|Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units|Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.||Participants|||Number
81800|NCT00986180|Secondary|Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain|50% response means >= 50% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Hours||95% Confidence Interval|Median
81801|NCT00986180|Secondary|Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain|30% response means >= 30% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Hours||95% Confidence Interval|Median
81802|NCT00986180|Secondary|Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event|Number of subjects that reported pruritus as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
81803|NCT00986180|Secondary|Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event|Number of subjects that reported constipation as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
81804|NCT00986180|Secondary|Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event|Number of subjects that reported vomiting as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
81805|NCT00986180|Secondary|Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event|Number of subjects that reported nausea as a treatment-emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
81806|NCT00986180|Secondary|Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation||Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.||Participants|||Number
81807|NCT00986180|Secondary|Incidence of 50% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Participants|||Number
81808|NCT00986180|Secondary|Incidence of 30% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Participants|||Number
81809|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population with subject's satisfaction assessment at end of the study.||Units on a Scale||Standard Deviation|Mean
81810|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population.||Units on a Scale|||Number
81811|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population with subject's satisfaction assessment on Day 5.||Units on a Scale||Standard Deviation|Mean
81812|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population.||Units on a Scale|||Number
81813|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population with CGIC assessment.||Units on a Scale||Standard Deviation|Mean
81814|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.||Units on a Scale|||Number
81837|NCT00986154|Secondary|The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality||12 months from time of randomization|mITT Analysis set||number of participants with event|||Number
81815|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/lst visit|Intent-To-Treat Population with PGIC assessment.||Units on a Scale||Standard Deviation|Mean
81816|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.||Units on a Scale|||Number
81817|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 10|Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
81818|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Total Score Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
81819|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
81820|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||score of scale||Standard Deviation|Mean
81821|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or “pins and needles” and numbness.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
81822|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or “pins and needles” and numbness.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
81823|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
81824|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
81825|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.||Units on a Scale||Standard Deviation|Mean
88694|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
81826|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 5|Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement||Units on a Scale||Standard Deviation|Mean
81827|NCT00986180|Secondary|Total Pain Relief (TOTPAR) for Low Back Pain – Summary Statistics at 5 Days|Pain Relief – 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
81828|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
81829|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 5 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
81830|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
81831|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
81832|NCT00986180|Secondary|SPID for Low Back Pain – Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a scale||Standard Error|Least Squares Mean
81833|NCT00986180|Secondary|SPID for Low Back Pain – Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a scale||Standard Error|Least Squares Mean
81834|NCT00986180|Secondary|Sum of Pain Intensity Difference (SPID) for Low Back Pain – Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a Scale||Standard Error|Least Squares Mean
81835|NCT00986180|Primary|Sum of Pain Intensity Difference (SPID) for Low Back Pain – Summary Statistics at 120 Hours (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.|0 hour (prior to first dose) and 120 hours|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).||Units on a scale||Standard Error|Least Squares Mean
81836|NCT00986154|Secondary|Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment|Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.|12 months from time of randomization|Safety Analysis Set||participants with an event|||Number
81838|NCT00986154|Primary|Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE|"Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.~Overall Study Period defined as The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."|12 months from time of randomization|(mITT) modified Intent To Treat Analysis Set||number or participants with an event|||Number
81839|NCT00986102|Secondary|Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
81840|NCT00986102|Secondary|Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
81841|NCT00986102|Secondary|Medical Resource Utilization|Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.|From Baseline (Day -1) upto the duration of hospital stay of a participant|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Days||Full Range|Median
81842|NCT00986102|Secondary|Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit||Day 5 or Day 7 or Day 14|Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication.||Participants|||Number
81843|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit||End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
81844|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)||Day 5 or Day 7 or Day 14|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
81845|NCT00986102|Primary|Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score|APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.|Baseline (Day -1)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
81846|NCT00986102|Primary|Duration of Antibiotic Therapy|Duration of doripenem and duration of doripenem plus oral antibiotics therapy|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Days||Standard Deviation|Mean
81847|NCT00986102|Primary|Number of Participants With Different Mode of Usage of Doripenem||5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
81848|NCT00986102|Primary|Number of Participants With the Usage of Doripenem as Per the Approved Indication|Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.||Participants|||Number
81849|NCT00985985|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs|All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.|Weekly assessments from first treatment dose up to 15 days after last treatment dose|Safety Population of this study consists of all randomized participants who have had study medication for at least once.||Participants|||Number
81850|NCT00985985|Secondary|Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.|Change in body weight was analyzed at Weeks 6, 12, and 24.|Baseline, Week 6, 12 and Week 24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point i.e. Week 6, Week 12 and Week 24. Missing values were not imputed.||kilogram (kg)||Standard Deviation|Mean
81851|NCT00985985|Secondary|Mean Daily Dose at Visit 4, 5, 6, 7 and 10|Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.|Weeks 1-2, 3-4, 5-6, 7-12 and 13-24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point. Missing values were not imputed.||Number of lozenges||Standard Deviation|Mean
81852|NCT00985985|Secondary|Mean Score of Relief of Craving/ Total Withdrawal Symptoms|The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal scale (MNWS). The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated on a 5 grade scale with scores ranging from 0 (best score) to 4 (worst score) i.e. none (score=0), slight (score=1), mild (score=2), moderate (score=3), and severe (score=4). For each symptom at each week, the average score was calculated as the average of the daily scores during that week. The total score was calculated as the sum of the 9 symptoms.|Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6|Analysis was carried out per FAS population, which consisted of all randomized subjects who have had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the number of participants analyzed (n) for this outcome measure. Missing values were not imputed.||Score on a scale||Standard Deviation|Mean
81853|NCT00985985|Secondary|Proportion of Participants With Seven Day Point Prevalence Abstinence|Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.|Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24|Analysis was carried out per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
81854|NCT00985985|Secondary|Rate of Long-term Successful Smoking Cessation at Week 24|Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than six cumulative days of smoking from Week 6 to Week 24.|From Week 6 to Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
81855|NCT00985985|Secondary|Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24|Continuous abstinence was verified by measurement of CO breath levels.|From baseline to Week 12 and Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
81856|NCT00985985|Primary|Rate of Successful Smoking Cessation at Week 6|Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.|From baseline to Week 6|Analysis was considered per Full Analysis Set (FAS) population. FAS population consisted of all randomized participants who had study medication for at least once with assessment data post-dosing.||Percentage of participants|||Number
81857|NCT00985959|Secondary|Median Time to First Response - Phase II|Time to first response is the duartion of time required to achieve first response to treatment|up to 54 weeks|Full analysis set: All participants who received at least one dose of the study medication.||Days||95% Confidence Interval|Median
81858|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I|Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2||ng/mL||Standard Deviation|Mean
81859|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I|Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2||ng/mL||Standard Deviation|Mean
81860|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2||ng/mL||Standard Deviation|Mean
81861|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)|Day 25 of Cycle 1|Pharmacokinetics-evaluable population: 16 participants were included in pharmacokinetics-evaluable population||ng/mL||Standard Deviation|Mean
81862|NCT00985959|Primary|Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II|Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions|54 weeks|Full analysis set: All participants who received at least one dose of the study medication.||Participants|||Number
81863|NCT00985959|Primary|Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)|Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1|6 weeks|Dose Limiting Toxicity set, Which includes all 18 participants in the Phase I||Participants|||Number
81864|NCT00985829|Other Pre-specified|Past Medical History of Radiotherapy|past medical history of radiotherapy to the site of tumor before its appearance(for another reason)|baseline|||lesions|||Number
81865|NCT00985829|Other Pre-specified|BCC Type|superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)|baseline|||lesions|||Number
81866|NCT00985829|Other Pre-specified|Location of Lesion||baseline|||lesions|||Number
81867|NCT00985829|Other Pre-specified|Cosmetic Result|excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration|1 month after termination of treatment course (with an average of 6 months after initiation of PDT)|cosmetic result was assessed among patients with complete response||lesions|||Number
81868|NCT00985829|Secondary|Histologic Resolution of Lesion|disappearance of the lesion in histologic examination|immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)|from those 9 lesions with clinically complete reponse , 3 lesions were biopsied and assessed histologically.||lesions|||Number
81869|NCT00985829|Primary|Clinical Response to Photodynamic Therapy|categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced|immediately after termination of treatment course (with an average of 5 month after initiation of PDT)|||lesions|||Number
81870|NCT00985790|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs).|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
81871|NCT00985790|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
81872|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination.|During the 28-day follow-up period (Days 0 to 27) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
81873|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.||subjects|||Number
81874|NCT00985790|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.||subjects|||Number
81875|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
81876|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
81877|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
81878|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
81879|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
88695|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
81880|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
81881|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
81882|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
81883|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and Day 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
81884|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
81885|NCT00985790|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.|At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
81886|NCT00985738|Primary|To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.|The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.|24 Months|"The study was terminated. Study end points were not reached. No data were collected"|||||
81887|NCT00985725|Secondary|Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9|The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies.|Baseline and week 9|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.||Scores on a scale||Standard Deviation|Mean
81888|NCT00985725|Secondary|Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF|The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.|Baseline and week 9|SAS||Scores on a scale||Standard Deviation|Mean
81889|NCT00985725|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Baseline and week 11|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.||Scores on a scale||Standard Deviation|Mean
81890|NCT00985725|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint|The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||Scores on a scale||Standard Deviation|Mean
81891|NCT00985725|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 9|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||Scores on a scale||Standard Deviation|Mean
81892|NCT00985725|Secondary|Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|Only the females from the SAS population were used and not all of them completed this outcome assessment.||Scores on a scale||Standard Deviation|Mean
81893|NCT00985725|Secondary|Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.||Scores on a scale||Standard Deviation|Mean
81894|NCT00985725|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint|The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||Scores on a scale||Standard Error|Least Squares Mean
81895|NCT00985725|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 9|FAS||percentage of participants|||Number
81896|NCT00985725|Secondary|Percent of Participants With CGI-S at up to 9 Weeks/Endpoint|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.||percentage of participants|||Number
81897|NCT00985725|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS||percentage of participants|||Number
81898|NCT00985725|Secondary|Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint|This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better.|Baseline and up to 9 weeks/Endpoint|FAS||Response scores||Standard Deviation|Mean
81899|NCT00985725|Secondary|Change From Baseline in BRIEF-A T-scores at Week 9, LOCF|BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|FAS||T-scores||Standard Error|Least Squares Mean
81900|NCT00985725|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 9|FAS||Scores on a scale||Standard Error|Least Squares Mean
81901|NCT00985725|Primary|Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.||T-scores||Standard Error|Least Squares Mean
81902|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24|Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.||number of events per 30 days||Standard Deviation|Mean
81903|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24|Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.||number of events per 30 days||Standard Deviation|Mean
81904|NCT00985712|Secondary|Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint|IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.|Week 24|Participants in full analysis population set who had Week 24 measurements.||units on a scale||95% Confidence Interval|Least Squares Mean
81905|NCT00985712|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint||Week 24|Participants in full analysis population set who had Week 24 measurements.||percentage of participants|||Number
81906|NCT00985712|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.|Baseline, Week 24|Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
81907|NCT00985686|Secondary|Spiritual Involvement and Belief Scale (SIBS)|Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format.|At 8 week intervals over a 24 week period||||||
81908|NCT00985686|Secondary|Spiritual Well-Being Scale (SWBS)|Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.|At 8 week intervals over a 24 week period||||||
81909|NCT00985686|Secondary|Profile of Mood States (POMS)|Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores.|At 8 week intervals over a 24 week period||||||
81910|NCT00985686|Secondary|Six Factor Self-Concept Scale|Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability.|At 8 week intervals over a 24 week period||||||
81911|NCT00985686|Secondary|Piers-Harris Children’s Self-Concept Scale - Second Edition (Piers Harris 2)|Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity.|At 8 week intervals over a 24 week period||||||
81912|NCT00985686|Primary|Hamilton Depression Rating Scale (HAMD)|Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24.|At 8 week intervals over a 24 week period|||units on a scale||Standard Error|Mean
81913|NCT00985686|Primary|Children's Depression Rating Scale Revised (CDRS-R)|Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.|At 8 week intervals over a 24 week period|||units on a scale||Standard Error|Mean
81914|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after dose 1 vaccination|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Titers||95% Confidence Interval|Geometric Mean
81915|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81916|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Fold||95% Confidence Interval|Mean
88696|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
81917|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Fold||95% Confidence Interval|Mean
81918|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after the first dose|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Subjects|||Number
81919|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
81920|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Subjects|||Number
81921|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
81922|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Fold||95% Confidence Interval|Mean
81923|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
81924|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
82101|NCT00984139|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
81925|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against A/California Strain.|Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Fold||95% Confidence Interval|Mean
81926|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against A/California Strain.|Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
81927|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against A/ California Strain.|"Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer.~Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer"|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Subjects|||Number
81928|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.||Titers||95% Confidence Interval|Geometric Mean
81929|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|On Days 0, 21, 42 and 63|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81930|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81931|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81932|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81933|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81934|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the pandemic vaccine (at Day 63)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81935|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81936|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81937|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81938|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (at Day 42).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
81939|NCT00985673|Secondary|Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0.~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.|||||
81940|NCT00985673|Secondary|Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity.~Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off.~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.|||||
81941|NCT00985673|Secondary|Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization.~Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.|||||
81942|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
81943|NCT00985673|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|"The day 329 was the last contact day with the subjects reporting serious adverse events.~SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects."|During the entire study period (Days 0-329).|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
81944|NCT00985673|Secondary|Number of Subjects Reporting Potential Immune Diseases (pIMDs).|The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-406).|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
81945|NCT00985673|Secondary|Number of Subjects Reporting Medically Attended Visits (MAEs).|The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Days 0-368).|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
81946|NCT00985673|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 84-day (Days 0-83) post-vaccination period.|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
81947|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
81948|NCT00985673|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
81949|NCT00985673|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
81950|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects||Subjects|||Number
81951|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated Cohort included all vaccinated subjects.||Subjects|||Number
81952|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.~Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.||Number of T cells/million||Standard Deviation|Mean
81953|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.~Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.||Number of T cells/million||Standard Deviation|Mean
81954|NCT00985543|Secondary|Adverse Events|Number of reported adverse events, severity of adverse events and relationship to study drug was assessed by questions, physical examination and laboratory parameters. Adverse event data was used to assess the safety and tolerability of low lopinavir/ritonavir doses.|Up to 11 weeks from screening to final study visit|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).||number of adverse events|||Number
81955|NCT00985543|Primary|Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h).|Pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval following administration of lopinavir/ritonavir 400/100mg, 200/150mg and 200/50mg twice daily.|at the end of each 7-day dosing phase|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).||ng.h/mL||90% Confidence Interval|Geometric Mean
81956|NCT00985504|Secondary|Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks|Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion.|Baseline through 8 weeks|All randomized participants.||percentage of participants|||Number
81957|NCT00985504|Secondary|Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks|The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score≥16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored).|Baseline through 8 weeks|Number of participants in each treatment group having time to relapse plus the participants censored. Duloxetine had 200 participants censored and escitalopram had 199 participants censored.||days|||Number
81958|NCT00985504|Secondary|Percentage of Participants Who Relapsed During 8 Weeks|Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score≥16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||percentage of participants|||Number
81959|NCT00985504|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8|The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
81960|NCT00985504|Secondary|Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8|"The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 2 (normal) to 6 (totally absent). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline."|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
81961|NCT00985504|Secondary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8|MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
81962|NCT00985504|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8|The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
81963|NCT00985504|Secondary|Patient’s Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8|The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit.|8 weeks|All randomized participants.||units on a scale||Standard Error|Least Squares Mean
81964|NCT00985504|Secondary|Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8|RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline at and least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
81965|NCT00985504|Secondary|Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8|AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
81981|NCT00985166|Primary|Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
81966|NCT00985504|Primary|Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8|The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.||units on a scale||Standard Error|Least Squares Mean
81967|NCT00985491|Secondary|Improvement in Type 2 Diabetic Status|Subjects who achieved HbA1c reduction of 0.5%|12 months|7 subjects were enrolled that had Type 2 Diabetes; endpoint evaluated subjects who achieved HbA1c reduction of 0.5%||% of subjects with T2DM|||Number
81968|NCT00985491|Primary|Assessment of % Excess Weight Loss|Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as [(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)] * 100).|12 months|||%EWL||Standard Error|Mean
81969|NCT00985439|Primary|Total Patient Pain Relief Over 0 to 12 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-12 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|12 hours.|||units on a scale||95% Confidence Interval|Least Squares Mean
81970|NCT00985257|Primary|Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.|1-2 hours|To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.||percent of blood glucose results|Participants||Number
81971|NCT00985231|Secondary|Subjective Ratings of Eye Strain|Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always|2 week visit|All Eligible, Dispensed Eyes, CISS Composite Score||CISS Composite Score||Standard Deviation|Mean
81972|NCT00985231|Primary|Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.|Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.|2 weeks|All Eligible, Dispensed Eyes with non-missing scores||eyes|Participants||Number
81973|NCT00985192|Secondary|Biomarker Correlations: Time to Progression|Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"||months||95% Confidence Interval|Median
81974|NCT00985192|Secondary|Biomarker Correlations: Progression Free Survival|Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"||months||95% Confidence Interval|Median
81975|NCT00985192|Secondary|Observed Biomarkers|Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"||number of tissue blocks|||Number
81976|NCT00985192|Secondary|Efficacy in Terms of Progression Free Response|Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan–Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.|evry 3 months in year 1, every 6 months after that|||months||95% Confidence Interval|Median
81977|NCT00985192|Secondary|Overall Survival|Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan–Meier method.|2.5 year|||months||95% Confidence Interval|Median
81978|NCT00985192|Primary|Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.|Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.|||percent subjects with disease control||95% Confidence Interval|Number
81979|NCT00985166|Primary|Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
81980|NCT00985166|Primary|Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||ELISA AB units/mL||95% Confidence Interval|Geometric Mean
81982|NCT00985166|Primary|Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
81983|NCT00985153|Primary|Number of Participants With Serious Vaccine-related CAEs|Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination|All subjects with follow-up for safety were included in the analysis.||Participants|||Number
81984|NCT00985153|Primary|Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||ELISA AB units||95% Confidence Interval|Mean
81985|NCT00985153|Primary|Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||ELISA AB units||95% Confidence Interval|Mean
81986|NCT00985153|Primary|Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||mIU/mL||95% Confidence Interval|Mean
81987|NCT00985153|Primary|Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer < 1.25 gpELISA units/mL at baseline, and followed protocol procedures.||gpELISA||95% Confidence Interval|Mean
81988|NCT00985153|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
81989|NCT00985153|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
81990|NCT00985153|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
81991|NCT00985153|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.||Participants|||Number
81992|NCT00985114|Primary|Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.||6 months|||% of participants|||Number
81993|NCT00985010|Secondary|Manganese Levels|From encephalopathic patients, we took individual blood samples, analyzed in the biochemistry laboratory at the National Institute of Neurology and Neurosurgery, Mexico, City, with a graphite furnace atomic absorption spectrometer, according to the technique reported by Pleban.|Up to six months we followed the recruited patients to determine who were still alive|All patients attended at the Internal Medicine Service with Hepatic Encephalopathy were included. The analysis was per protocol.||μg/L||Standard Deviation|Mean
81994|NCT00985010|Primary|Clinical Evolution|Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room|six months|We made a clinical follow up from nine encephalopathic patients. After six months we studied the differences in Mn, hemoglobin, etc., between those patients still alive and those who died.||participants|||Number
81995|NCT00984867|Secondary|Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline|To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
81996|NCT00984867|Secondary|Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise|To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
81997|NCT00984867|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg|To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full analysis set, participants with baseline SBP>=130mmHg and Week 8 (LOCF) value||mmHg||95% Confidence Interval|Least Squares Mean
81998|NCT00984867|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
81999|NCT00984867|Secondary|Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%|To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full analysis set, participants with baseline HbA1c >=8% and Week 24 (LOCF) value||Percent||95% Confidence Interval|Least Squares Mean
82000|NCT00984867|Secondary|Adjusted Mean Change in Body Weight|To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
82001|NCT00984867|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
82002|NCT00984815|Secondary|Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health.|Baseline and 54 Weeks|55 participants who completed the satisfaction with dyspepsia-related health questions of the SODA questionnaire at baseline and week 54.||Scores on a scale||Standard Deviation|Mean
82003|NCT00984815|Secondary|Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.||Scores on a scale||Standard Deviation|Mean
82004|NCT00984815|Primary|Number of Participants With Treatment Emergent Adverse Events||54 weeks|All participants enrolled and who received at least one dose of study drug comprised the Safety Population.||participants|||Number
82005|NCT00984815|Secondary|Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.||Scores on a scale||Standard Deviation|Mean
82006|NCT00984698|Primary|Depression|Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants completed 75% of psychotherapy sessions; 20 participants completed study assessment at 12-week post-treatment time point~PCGT arm: 14 participants completed 75% of psychotherapy sessions; 17 participants completed study assessment at 12-week post-treatment time point"||units on a scale||Standard Deviation|Mean
82007|NCT00984698|Secondary|PTSD|Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants who completed 75% of psychotherapy sessions; 20 participants who completed 12-week post-treatment assessment~PCGT arm: 14 participants who completed 75% of psychotherapy sessions; 17 participants who completed 12-week post-treatment assessment"||units on a scale||Standard Deviation|Mean
82008|NCT00984659|Primary|SOBDA Threshold for Response Assessed as Mean Change From Baseline to Last Treatment Week in the SOBDA Score Based on Forced Expiratory Volume in One Second (FEV1) Change From Baseline of 50 Milliliters (mL) to <100 mL|FEV1 response was rated as 1=No change or worse (i.e., change of <50 mL); 2=Better (i.e., change of 50 to <100 mL); 3=Much better (i.e., change of >=100 mL). The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on study assessment (FEV1) scores pre-specified as “better” or demonstrating meaningful improvement.|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||mL||Standard Deviation|Mean
82032|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)|Change from baseline (CFB) in haematocrit and Eosinophils.|baseline and 48 weeks|TS||% of laboratory test substance||Standard Deviation|Mean
82033|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)|Change from baseline (CFB) in Red blood cells.|baseline and 48 weeks|TS||10^12 cells/L||Standard Deviation|Mean
88697|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
82009|NCT00984659|Primary|SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CRQ-SAS Dyspnea Domain (DD) Response Rated as “Better”|The threshold of response (TOR) is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit. The TOR was evaluated as the change from Baseline in the SOBDA score based on CRQ-SAS scores pre-specified as “better” or demonstrating meaningful improvement. The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing).|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
82010|NCT00984659|Primary|SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CGI-C Response Rated as “Better”|The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on CGI-C scores pre-specified as “better” or demonstrating meaningful improvement. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse, 2, worse; 3, no change; 4, better; 5, much better.|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
82011|NCT00984659|Primary|SOBDA Threshold for Response Assessed as Mean Change From the Previous Week’s SOBDA Score Based on a Participant-completed PGAC Score Rated of “Better”|Changes from Baseline in the SOBDA score for responders (Rs) and non-responders (NRs) (using the PGAC assessment; 1 [much worse] to 5 [much better]), together with the cumulative proportions of Rs and NRs, was used to establish the threshold for defining SOBDA questionnaire Rs. The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on PGAC scores pre-specified as “better” or demonstrating meaningful improvement.|Baseline (last week of the 2-week Run-in Period) and Weeks 1, 2, 3, 4, 5, and 6 (6-week Treatment Period)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||scores on a scale||Standard Deviation|Mean
82012|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by Physician-completed mMRC and Participant-completed mMRC Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The mMRC ranges from 0 (no breathlessness except with strenous exercise) to 4 (too breathless to leave the house; breathless when dressing/undressing) and is completed by the clinician or the participant as indicated. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the Physician-completed (Ph-C) and Participant-completed (Pa-C) mMRC conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
82013|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CRQ-SAS Dyspnea Domain (DD) Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes of responders (Rs) versus non-responders (NRs). The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing). Changes in mean SOBDA scores during the last treatment week in Rs and NRs using definitions based on the CRQ-SAS DD conducted at Visit 3/PD were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||Scores on a scale||Standard Deviation|Mean
82014|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CGI-C Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the CGI-C conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||scores on a scale||Standard Deviation|Mean
82034|NCT00984620|Secondary|Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination|No number of participants with clinically relevant abnormalities in vital signs and physical examination.|48 weeks|TS||participants with abnormality|||Number
85187|NCT00952848|Primary|Change in Pain Score|"Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15.~Scale is 0 (none) to 10 (severe)"|15 days|Patients treated with MC5A devise for 10 consectuvive days||units on a scale||90% Confidence Interval|Median
82015|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Physician-completed and Participant-completed mMRC Response at Visit 3/PD|A Physician-completed and Participant-completed mMRC responder was defined as a participant who had a score decrease of one unit or more between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had the same score or an increase in score.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||participants|||Number
82016|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by CRQ-SAS Dyspnea Domain Response at Visit 3/PD|A CRQ-SAS dyspnea domain responder was defined as a participant who had a score increase of 0.5 units or more for the dyspnea domain of the CRQ-SAS between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had a decrease in the score, or an increase of less than 0.5 units.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||participants|||Number
82017|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Clinician Global Impression of Change Question (CGI-C) Response at Visit 3/PD|"Clinicians were asked to provide their clinical impression regarding change in the participant’s shortness of breath by CGI-C. This was evaluated on a 1-5 Likert scale: 1 (much worse) to 5 (much better), with 3 being no change. A CGI-C responder was defined as a participant who had a response of better (4) or much better (5), and a non-responder was defined as a participant who had a response of much worse (1), worse (2), or no change (3)."|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||participants|||Number
82018|NCT00984659|Primary|Change From the Previous Week to the Current Week’s SOBDA Score by Participant-completed PGAC Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/PD (End of the 6-week Treatment Period or PD)|"Responsiveness reflects the ability of the SOBDA questionnaire to detect change under conditions of known change. Responders (Rs)=participants (par.) with a rating of better/much better (score of 4/5) on the PGAC (range; 1 [much worse] to 5 [much better]) at the relevant week; NRs=par. with a response of “much worse, worse, or no change (score of 3). Mean difference between Rs and NRs in the change from the previous week to the current week’s SOBDA score was calculated. For Visit 3/PD, the change from Baseline to the last treatment week's SOBDA score for Rs and NRs was calculated."|Baseline; Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.||scores on a scale||Standard Deviation|Mean
82019|NCT00984659|Primary|Participants (Par.) Classified as Responders/Non-responders According to the Patient Global Assessment of Change (PGAC) Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/Premature Discontinuation (PD) (the End of the 6-week Treatment Period or PD)|"The PGAC is par. completed on a 1-5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Responders were defined as par. with a rating of better or much better (score of 4 or 5) on the PGAC at the relevant week; non-responders were defined as par. with a response of “much worse, worse, or no change on the PGAC. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect."|Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|Modified Intent-to-Treat (MITT) Population: all participants randomized to treatment who received at least one dose of study medication. Analyses were conducted on data available for each specified time point.||participants|||Number
82020|NCT00984659|Primary|Known Group Validity (KGV) for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of CGI-S Scores at Visit 2|SOBDA KGV refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the CGI-S score. Clinicians were asked to assess the severity of the participant’s dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe). KGV was confirmed if the SOBDA score increased with increasing values of CGI-S, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatement on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the CGI-S score at Visit 2 were analyzed.||scores on a scale||Standard Error|Least Squares Mean
82021|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Participant-completed (ParC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the ParC mMRC. The participant rated the degree of his/her dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of ParC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Participant-completed mMRC score at Visit 2 were analyzed.||scores on a scale||Standard Error|Least Squares Mean
82536|NCT00979654|Secondary|Number of Participants With Positive Anti-Drug Antibody|Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.|Day 1 and Week 12, 24, 52, 104, 156 and 168|Safety Population included all participants who received at least one dose of investigational product.||Participants|||Number
82022|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Physician-completed (PyC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the PyC mMRC. The physician rated the degree of the participant's dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of PyC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Physician-completed mMRC score at Visit 2 were analyzed.||scores on a scale||Standard Error|Least Squares Mean
82023|NCT00984659|Primary|Convergent Validity (CV) for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) Dyspnea Domain Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the CRQ-SAS dyspnea domain score. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 will occur if the data from the 2 variables lie exactly on a line. The CRQ is a 20-item instrument measuring 4 domains (each measured on a scale of 1 [maximum impairment] to 7 [no impairment]) of functioning: mastery, fatigue, emotional function, and dyspnea.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.||Pearson's correlation coefficient|||Number
82024|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Clinician Global Assessment of Dyspnea Severity (CGI-S) Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure the required information and was assessed by examining the relationship between the SOBDA score with the CGI-S score. Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other. Clinicians were asked to assess the severity of the participant’s dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe).|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.||Spearman rank correlation coefficient|||Number
82025|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as Correlations of the Baseline SOBDA Score With Participant-completed Modified Medical Research Council (mMRC) and Physician-completed mMRC Scores at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the participant/physician-completed mMRC Dyspnea Scale assessments. The physician/participant rated the degree of the participant's dyspnea (trouble breathing) on the 5-point mMRC scale (0, none; 4, very severe). Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed. One participant who rated their own trouble breathing had missing data for the physician assessment.||Spearman rank correlation coefficient|||Number
82026|NCT00984659|Primary|Test-retest Reliability (T-RR) of SOBDA Scores Measured as the Difference in the SOBDA Weekly Score Between Week 1 and Week 2 of the 2-week Run-in Period|T-RR=stability during repeat measures over time in a stable population. SOBDA score was determined by the 13-item (it.) scoring algorithm, assigning a weekly mean score of 1-4 (higher scores=more severe breathlessness with daily activities) based on the mean of 7 days of data (or >=4 days). Daily total score is computed from the mean of the participant's (par.) scores on the 13 it. (>=7 it. must have non-missing responses). Only scores of stable par. (indicating no change [score=3] on the par.-completed Patient Global Assessment of Change [PGAC]; 1 [ much worse] to 5 [much better]) were used.|Week 1 and Week 2 of the 2-week Run-in Period|Run-in Population. Data from participants with weekly SOBDA scores at Week 1 and Week 2 of the 2-week Run-in Period and reporting no change on the second weekly PGAC were analyzed.||scores on a scale||Standard Deviation|Mean
82027|NCT00984659|Primary|Internal Consistency (IC) of the Shortness of Breath With Daily Activities (SOBDA) Questionnaire in Participants With Chronic Obstructive Pulmonary Disease (COPD) Assessed as Cronbach's Alpha Value|Cronbach’s alpha (CA) is a measure of the IC of the 13-item SOBDA questionnaire (completed via electronic diary by a sample of participants). It is the ratio of the variance (var.) of the sum of the individual scores and the var. of the total score. The var. of the sum of a group of independent variables is the sum of their var.; thus, if the variables are positively correlated, the var. of the sum will be increased. If the items making up the score are identical and so perfectly correlated, CA=1. If the items are independent, CA=0. Higher scores indicate a more reliable (precise) instrument.|Day 1 of the 2-week Run-in Period|Run-in Population: all participants who completed Visit 2 (Day 1 of Treatment Period), including those who were not randomized, were randomized but did not receive a dose of study medication, and those who were randomized and received study medication. Participants with a score for each SOBDA item on Day 1 of the 2-week Run-in Period were analyzed.||ratio of variance|||Number
82028|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)|Change from baseline (CFB) in PT-INR (ratio).|baseline and 48 weeks|TS||ratio||Standard Deviation|Mean
82029|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)|Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.|baseline and 48 weeks|TS||U/L||Standard Deviation|Mean
82030|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)|Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.|baseline and 48 weeks|TS||mmol/L||Standard Deviation|Mean
82031|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)|Change from baseline (CFB) in Platelets and white blood cells.|baseline and 48 weeks|TS||10^9 cells/L||Standard Deviation|Mean
82035|NCT00984620|Secondary|Laboratory Test Abnormalities and Study Medication Tolerabilities|Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.|48 weeks|Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.||participants|||Number
82036|NCT00984620|Secondary|Time to Reach a Plasma HCV RNA Level BLD While on Treatment|Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment|48 weeks|PPS||week||Inter-Quartile Range|Median
82037|NCT00984620|Secondary|Viral Load (HCV RNA) at All Visits During Treatment and Follow-up|Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.|From baseline to 72 weeks|PPS||IU/mL||Standard Deviation|Mean
82038|NCT00984620|Secondary|Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy|Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.|72 weeks|PPS||participants|||Number
82039|NCT00984620|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.|up to 48 weeks|PPS||participants|||Number
82040|NCT00984620|Secondary|Virological Response at Week 36 (W36VR)|Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.|36 weeks|PPS||participants|||Number
82041|NCT00984620|Secondary|Virological Response at Week 24 (W24VR)|virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.|24 weeks|PPS||participants|||Number
82042|NCT00984620|Secondary|Rapid Virological Response at Week 4 (RVR)|Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.|4 weeks|PPS||participants|||Number
82043|NCT00984620|Primary|Virological Response at Week 28 (W28VR)|Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.|28 weeks|Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.||participants|||Number
82044|NCT00984594|Secondary|Lysholm Score at 24 Months|The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
82045|NCT00984594|Secondary|Magnetic Resonance Imaging (MRI) Results|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
82046|NCT00984594|Secondary|IKDC Assessment|The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
82047|NCT00984594|Secondary|Current Health Assessment (CHA)|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0–100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
82048|NCT00984594|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.||units on a scale||Full Range|Mean
82049|NCT00984568|Primary|Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50|Response at Week 4 was defined as a minimum decrease from baseline in Mayo score of 3 points and 30%. Steroid-free remission at Week 50 was defined as a total Mayo score (including endoscopic assessment) of 2 points or lower and no individual subscore exceeding 1. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician’s global assessment. Each subscore is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst).|Week 50|The FAS consisted of all randomized participants who received at least one dose of study treatment.||Participants|||Number
82050|NCT00984568|Secondary|Number of Participants Achieving Treatment Response|"Response was defined as a minimum decrease from baseline in total Mayo score of 3 points and 30% up to and including 4 weeks after the start of treatment. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician’s global assessment. Each subscore~is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst)."|Up to Week 4|The full analysis set (FAS) consisted of all randomized participants who received at least one dose of study treatment.||Participants|||Number
82174|NCT00983515|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
82051|NCT00984542|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
82052|NCT00984542|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
82053|NCT00984542|Secondary|Best Response|"Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details):~complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On‐treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response. 8 patients were not evaluable.||participants|||Number
82054|NCT00984542|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days|Total number of patients reported with any toxicity||participants|||Number
82055|NCT00984542|Primary|Time to Progression|Estimated probable duration from on-study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)|All patients are included in the analysis on intention-to treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.||days||95% Confidence Interval|Median
82056|NCT00984490|Secondary|Changes in Circulating Insulin-like Growth Factor 1 (IGF-1) and IGF Binding Protein 3 (IGFBP-3)|Effect of study drug on circulating IGF-1 and IGFBP-3 as measured in ng/mL in peripheral blood samples taken pre-treatment and post-treatment with metformin|baseline and 23 days|No levels of IGF-1 and IGFBP-3 were determined. This clinical trial was closed due to slow accrual.||units on a scale||Standard Deviation|Mean
82057|NCT00984490|Primary|Change in Ki67 Levels Before and After Treatment|Change in Ki67 levels in pre-treatment, pre-surgery and post-treatment, surgically excised breast tissue. Measured by percentage of positive-staining nuclei with a minimum of 0% to a maximum of 100%. A mean score is determined.|baseline and between 8-23 days|No Ki67 levels were determined. This clinical trial was closed due to slow accrual||percentage of stained cell nuclei||Standard Deviation|Mean
82058|NCT00984334|Primary|Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing.|Incidence and severity of treatment emergent adverse events on single dosing.|3 weeks|Intent to treat.||participants|||Number
82059|NCT00984308|Secondary|Sleep Apnea Treatment Rate||One year|Among the 58 intervention patients with a diagnosis of sleep apnea, CPAP data were available for 57. Among the 7 control patients who received polysomnography as part of usual care, 5 had sleep apnea: CPAP data were available for 4 patients (2 did not receive any CPAP and 2 had CPAP therapy), the data card was unavailable for 1 patient.||participants|||Number
82060|NCT00984308|Primary|Hypertension Control|Medication-Adjusted Systolic Blood Pressure|One year|ITT||mm Hg||Standard Deviation|Mean
82061|NCT00984308|Primary|Sleep Apnea Diagnosis Rate|The number of patients with a diagnosis of sleep apnea|The entire study period (baseline and up to one-year)|The intervention patients had polysomnography at baseline (n=102) whereas control patients either had polysomnography as part of usual care (n=7) or at the end of the study as part of the study protocol (n=85). The n=7 patients who had polysomnography as part of usual care were included in the analysis for this outcome.||participants|||Number
82062|NCT00984295|Primary|Antibody Response to Tetanus at 6 Weeks Postvaccination – GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
82063|NCT00984295|Primary|Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT|Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
82175|NCT00983489|Primary|Exclusive Breast Feeding Rate at Six Weeks Postnatal Age||6 weeks|||Participants|||Number
82064|NCT00984295|Primary|Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
82065|NCT00984295|Primary|Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||units/mL||95% Confidence Interval|Geometric Mean
82066|NCT00984295|Primary|Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||units/mL||95% Confidence Interval|Geometric Mean
82067|NCT00984295|Primary|Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
82068|NCT00984295|Primary|Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
82069|NCT00984295|Primary|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||IU/mL||95% Confidence Interval|Geometric Mean
82070|NCT00984295|Primary|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT|Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||ELISA Ab units/mL||95% Confidence Interval|Geometric Mean
82071|NCT00984295|Primary|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||mIU/mL||95% Confidence Interval|Geometric Mean
82072|NCT00984295|Primary|Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL|Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
82073|NCT00984295|Primary|Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL|Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
82074|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer|Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
82075|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer|Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
82076|NCT00984295|Primary|Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL|Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
82077|NCT00984295|Primary|Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL|Antibody response to Diphtheria at 6 weeks postvaccination|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
82102|NCT00984139|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
82078|NCT00984295|Primary|Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL|Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline|6 weeks Postvaccination|"The per-protocol analysis set included participants~who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to~varicella at baseline, and followed protocol procedures."||Participants|||Number
82079|NCT00984295|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
82080|NCT00984295|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
82081|NCT00984295|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline|6 Weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
82082|NCT00984282|Secondary|AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)|Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration.|A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)|Pharmacokinetic (PK) analysis set=participants with PK data collected after 14 days of uninterrupted and unmodified dosing of sorafenib. If an interruption occurred within 14 days prior to the sample, no doses may be missed for 3 days prior to the sample, and no more than 3 doses could be missed 4 to 14 days prior to the sample collection date.||mg*h/L||Standard Deviation|Geometric Mean
82083|NCT00984282|Secondary|Maximum Percent Reduction in Target Lesion Size Based on Central Assessment|The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS||Percentage of participants|||Number
82084|NCT00984282|Secondary|Duration of Response (DOR) Based on Central Assessment|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS - responders only||Days||Full Range|Median
82085|NCT00984282|Secondary|Response Rate Based on Central Assessment|Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS||Percentage of participants||95% Confidence Interval|Number
82086|NCT00984282|Secondary|Disease Control Rate (DCR) Based on Central Assessment|Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.||Percentage of participants||95% Confidence Interval|Number
82087|NCT00984282|Secondary|Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation])|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS||Days||95% Confidence Interval|Median
82088|NCT00984282|Secondary|Overall Survival (OS)|Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|Full Analysis Set (FAS)||Percentage of participants|||Number
82100|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||Subjects|||Number
82089|NCT00984282|Primary|Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.|Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years|Full Analysis Set (FAS). The primary population for efficacy analysis was the FAS. The FAS was identical to the intent-to-treat (ITT) population, which was defined as all randomized participants. Participants were analyzed as randomized.||Days||95% Confidence Interval|Median
82090|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of Area Under the Curve|Plasma concentrations were used to determine the pharmacokinetic curves with determinations of area under the curve (AUC).The smallest AUC Day 0-6.5 associated with protection from detectable parasitemia, and the highest AUC Day 0-6.5 observed in any cases of malaria (prophylactic failures) were to be reported.|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Analysis was done on subjects who completed the study according to protocol||ng*day/ml||Standard Deviation|Mean
82091|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of T1/2.|Plasma concentrations (ng/ml) were used to determine the elimination half life (t1/2) of atovaquone (days).|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Population for analysis included According to Protocol Population.||Days||Standard Deviation|Mean
82092|NCT00984256|Primary|Prophylactic Efficacy of 3 Different Doses of Atovaquone/Proguanil (Malarone@) Given 1 Week Before Infectious Sporozoite Challenge Using the P. Falciparum Human Challenge Model.|Number of participants with prophylactic efficacy was determined by the absence of cases of malaria parasitemia, defined as microscopically detectable parasitemia by Giemsa-stained thick smears, in those receiving any dose of Malarone as compared to the control (no treatment) group|Days 6-20|"Analysis population was According to Protocol which included participants meeting all eligibility criteria, not meeting any elimination criteria, complying with defined protocol procedures and for whom data are available."||participants with negative parasitemia|||Number
82093|NCT00984204|Secondary|Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure||3 months|||participants|||Number
82094|NCT00984204|Primary|Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.||30 mins|||participants|||Number
82095|NCT00984204|Primary|Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.||7 days|||participants|||Number
82096|NCT00984165|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|36 months|||participants|||Number
82097|NCT00984165|Primary|Response to Graft Versus Host Disease (GVHD) Treatment|The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score >/= 70%). Non-responder (NR) <50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score </= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.|Up to 100 days|"No results were collected on the Donor Lymphocyte Infusion-Donor Arm. This arm allowed for collection of the lymphocytes on healthy donors for infusion on the DLI/Radiation Arm or the DLI/Control Group."||participants|||Number
82098|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||Subjects|||Number
82099|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||subjects|||Number
82120|NCT00983983|Secondary|Rate of Change in ALSFRS-R in Units/Month|Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.|Over 5 months|||units on a scale/month||95% Confidence Interval|Mean
82103|NCT00984139|Secondary|Number of Subjects With Solicited Local and General Symptoms|"Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.~Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius."|During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
82104|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values|The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||Subjects|||Number
82105|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values|"The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.~Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure."|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||subjects|||Number
82106|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.||subjects|||Number
82107|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration|||ng-hr/mL||Standard Deviation|Mean
82108|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration|||ng-hr/mL||Standard Deviation|Mean
82109|NCT00984061|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration|||ng/mL||Standard Deviation|Mean
82110|NCT00984022|Secondary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.|Participants were assessed to see whether or not the surface area of the cellulitis was reduced by at least 30% and the number of such participants was reported.|2 weeks|||Participants|||Number
82111|NCT00984022|Secondary|Change in Patient Rating of Pain|Change in mean pain score based on patient self-report, using Wong-Baker FACES pain rating scale. Scale ranges from 0 to 5, where 5 means the worst pain possible and 0 means no pain at all.|Baseline and 2 weeks|||Scores on a scale||Standard Deviation|Mean
82112|NCT00984022|Primary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess|Participants were assessed to see whether or not the surface area of the abscess was reduced by at least 30%, and the number of such participants is reported.|2 weeks|||Participants|||Number
82113|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82114|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82115|NCT00984009|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
82116|NCT00983983|Primary|Tolerability|Number of participants who completed the study on their assigned study intervention.|5 months|The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention).||participants|||Number
82117|NCT00983983|Primary|Serious Adverse Events|SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|5 months|||Number of Serious Adverse Events|||Number
82118|NCT00983983|Primary|Safety Outcomes: Frequency of Adverse Events||5 months|||Total Number of Adverse Events|||Number
82119|NCT00983983|Secondary|Biomarkers of Body Composition and Lipid Metabolism||5 months follow-up||||||
82121|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||hours||Full Range|Median
82122|NCT00983957|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
82123|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters|The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).|Screening, Day 1, Day 67, Day 77|All participants who received at least one dose of study drug.||participants|||Number
82124|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs|Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.|Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge|All participants who received at least one dose of study drug.||participants|||Number
82125|NCT00983957|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*Pre-treatment (PreRx), Hemoglobin (low) as <0.85*PreRx, Aspartate Aminotransferase (AST) (high) as >1.25*PreRx if PreRx > upper limits of normal (ULN); >1.25*ULN if PreRx <=ULN; >1.25*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx <1; ≥2 if PreRx = Missing.|From start of treatment (Day 1) up to Day 78 or discharge|All participants who received at least one dose of study drug.||participants|||Number
82126|NCT00983957|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug|All participants who received at least one dose of study drug.||participants|||Number
82127|NCT00983957|Primary|Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
82128|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug||hours||Full Range|Median
82129|NCT00983957|Secondary|Time of Maximum Observed Plasma Concentration of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||hours||Full Range|Median
82130|NCT00983957|Secondary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
82131|NCT00983957|Primary|Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
82132|NCT00983957|Secondary|Maximum Observed Plasma Concentration of Norgestrel|Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography–mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
82133|NCT00983957|Primary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol|Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77|All participants who received the study drug.||picogram per millilitre (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
82134|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82135|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82136|NCT00983931|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
82137|NCT00983918|Secondary|Analgesic Consumption||24 hours||||||
82138|NCT00983918|Primary|Pain Measured on Verbal Scale of 0-10, With 0 Being Absolutely no Pain, and 10 Being the Worst Pain in That Subjects Life.||24 hours|||units on a scale||Standard Deviation|Mean
82139|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the theophylline plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable theophylline plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration|||µg-hr/mL||Standard Deviation|Mean
82140|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the theophylline plasma concentration versus time curve, from time 0 to the time of the last measurable theophylline concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration|||µg-hr/mL||Standard Deviation|Mean
82141|NCT00983905|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that theophylline drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration|||µg/mL||Standard Deviation|Mean
82142|NCT00983892|Primary|Summed Symptom Severity|Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory. 8 core symptoms rated by the patient on a scale of 0 to 10. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest. Higher scores mean WORSE or GREATER SYMPTOM BURDEN.|3 months|||units on a scale||Standard Deviation|Mean
82143|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)|Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data||ratio (test/reference)||Full Range|Median
82144|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)|Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data||ratio (test/reference)||Full Range|Median
82145|NCT00983853|Secondary|Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure||through 12 weeks after first dose of study drug|subjects with available plasma concentration data||ratio (test/reference)||90% Confidence Interval|Least Squares Mean
82146|NCT00983853|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment||12 weeks after last dose of study drug|subjects who received at least 1 dose of study drug.||participants|||Number
82147|NCT00983853|Secondary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12|number of subjects with undetectable HCV RNA|4 and 12 weeks after the first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug||participants|||Number
82148|NCT00983853|Primary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 12||12 weeks after first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug||participants|||Number
82149|NCT00983827|Primary|Safety|Number of procedure related adverse events that occurred during study.|16 weeks|||adverse events|||Number
82150|NCT00983801|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone. n=number of participants with at least 1 measurement available during the study therapy period.||participants|||Number
82151|NCT00983801|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone and had at least one measurement available during the study therapy period.||participants|||Number
82152|NCT00983801|Other Pre-specified|Number of Participants With Best Response as Assessed With Modified RECIST|Best overall response that any participant can have is the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. PR criteria should be met again after 4 weeks and before 6 weeks. Stable disease (SD)=Neither PR or progressive disease (PD) are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 4 for definition of PD.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).||participants|||Number
82153|NCT00983801|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. DR=Drug-related. Any Peripheral Neuropathy includes peripheral sensory and motor neuropathies, including muscle weakness, and hypoaesthesia.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks)|Participants who received at least 1 dose of study therapy.||participants|||Number
82154|NCT00983801|Secondary|Percentage of Participants With Disease Control Rate|Defined as percentage of participants whose best response was PR, CR, or SD as determined by the investigator. SD=Neither PR or PD are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 1 for definition of CR or PR and refer to outcome measure 4 for definition of PD. A 2-sided 95% CI was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).||percentage of participants||95% Confidence Interval|Number
82155|NCT00983801|Secondary|Progression Free Survival (PFS)|PFS=the time interval from date of randomization to the earliest (first) progression or date of death. Participants who progressed or died were counted as events. PD=≥20% increase in sum of LD of target lesions and an absolute increase ≥5 mm in tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated using the Kaplan-Meier product-limit method for all treated participants and a 2-sided 95% CI for the median PFS was computed by Brookmeyer and Crowley method).|From the date of initiation of study therapy to the date of progression (up to 8.1 months).|Participants who received at least 1 dose of ixabepilone. Participants who died without reporting prior progression were considered to have progressed on their death day. Participants who did not progress or die were censored on their last tumor assessment day. Participants without on-study tumor assessments were censored at start date of therapy.||months||95% Confidence Interval|Median
82156|NCT00983801|Secondary|Duration of Response|Defined as the period in months from the time measurement criteria are first met for PR or CR until the first date of documented PD or death. Refer to outcome measure 1 for CR and PR. PD=≥20% increase in the sum of LD of target lesions and an absolute increase of at least 5 mm of tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated by Kaplan-Meier product limit method and a 2-sided 95% CI for median duration was computed by Brookmeyer and Crowley method.|From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)|Participants who received at least 1 dose of ixabepilone and had either CR or PR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
88698|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
82157|NCT00983801|Secondary|Time to Response|Time to response is defined as the time in weeks from the first dose of study therapy until measurement criteria are first met for PR or CR (whichever status is recorded first). CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node lesions, the short axis of all nodes should measure <10 mm. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks of initial assessment.|Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)|Participants who received at least 1 dose of study therapy and had a response of either CR or PR.||weeks||Full Range|Median
82158|NCT00983801|Primary|Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring <10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).||percentage of participants||95% Confidence Interval|Number
82159|NCT00983749|Primary|Safety (Including Endpoints Such an Increase NIHSS During or Immediately After ECP, and Acute Hemorrhage on Repeating Imaging, Serious Adverse Events Related to ECP, Mortality)|Safety was evaluated by the incidence of serious adverse events (SAEs) or acute neurological deterioration in relation to the study device and/or procedures at 30 days, the incidence of acute symptomatic hemorrhage on repeat imaging at 24 hours, the incidence of all adverse events (AEs) in the first 48 hours, and mortality at 30 days. The National Institutes of Health Stroke Scale (NIHSS) is a stroke severity scale, based on examination, that goes from 0 (no deficit) to a maximum of 42. Acute neurological deterioration – which was captured as a serious adverse event - was defined as a ≥4-point increase on the NIHSS, or a ≥2-point decline in level of consciousness item 1a on the NIHSS, or a new neurological deficit, or clinically significant worsening of motor function lasting more than 8 hours and attributable to a neurological entity. Symptomatic intracranial hemorrhage was defined as new hemorrhage on CT that was associated with acute neurological deterioration.|30 days|||participants|||Number
82160|NCT00983749|Primary|Feasibility and Tolerability of External Counterpulsation|The first primary outcome measure was tolerability and feasibility. Tolerance was defined as the absence of any indications to stop the procedure or reduce the pressure to a non-therapeutic level. Feasibility was defined in the full-pressure group as the sustained (at least 30 minutes) tolerance of any pressure capable of causing a 15% augmentation of MFV in 90% of subjects, and defined in the sham-pressure group as the sustained tolerance of the sham pressure in all subjects.|During one hour of treatment|||participants|||Number
82161|NCT00983645|Secondary|Lipid Levels||6 months post-transplant|Data cannot be located for analysis.|||||
82162|NCT00983645|Secondary|Post-transplant Diabetes Mellitus||6 months post-transplant|Data cannot be located for analysis.|||||
82163|NCT00983645|Secondary|Renal Function||6 months post-transplant|Data cannot be located for analysis.|||||
82164|NCT00983645|Primary|Rejection||6 months post-transplant|Data cannot be located for analysis.|||||
82165|NCT00983541|Secondary|Evaluate Rate of Distant Mets Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
82166|NCT00983541|Secondary|Evaluate Local Control Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
82167|NCT00983541|Secondary|Evaluate Tumor Response Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months.|Trial did not meet accrual goals so analysis was not performed|||||
82168|NCT00983541|Secondary|Evaluate Progression Free Survival Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
82169|NCT00983541|Secondary|Evaluate the Rate at Which Patients With Unresectable Extrahepatic Cholangiocarcinoma Become Resectable Following Gemcitabine and Radiation Therapy.||9 months|Trial did not meet accrual goals so analysis was not performed|||||
82170|NCT00983541|Secondary|Evaluate Overall Survival Ratefollowing Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed|||||
82171|NCT00983541|Primary|Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost.||Toxicity was assessed for each patient over the course of the study treatment and follow-up stage which together lasted 9 months. Only one patient was enrolled.|||participants|||Number
82172|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82173|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82176|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|12 months|All randomized participants who received the intervention as randomized and who completed a 12 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||kg/meter square||Standard Deviation|Mean
82177|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|9 months|All randomized participants who received the intervention as randomized and who completed a 9 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||kg/meter squared||Standard Deviation|Mean
82178|NCT00983476|Secondary|Quality of Life: Sexual Life|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale.~The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
82179|NCT00983476|Secondary|Quality of Life: Self-Esteem|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale.~The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and had data at 6 months were included in the analyses. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
82180|NCT00983476|Secondary|Quality of Life: Physical Functioning|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale.~The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
82181|NCT00983476|Primary|Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor.~The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
82182|NCT00983476|Primary|Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor.~The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||units on a scale||Standard Error|Mean
82183|NCT00983476|Primary|Body Mass Index (BMI) Within Obese Sample|BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30|6 months|Analyses excluded participants with BMI of 28-29.9 (overweight) at baseline, leaving only those with BMI >= 30 at baseline who received the intervention as randomized.||kilogram/(meters squared)||Standard Error|Mean
82184|NCT00983476|Primary|Body Mass Index (BMI)|BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1|6 months|All randomized participants who received any intervention as randomized were included in the primary analyses, regardless of the number of assessments completed. Receiving intervention as randomized was defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).||kg/(meters squared)||Standard Error|Mean
82185|NCT00983437|Secondary|Change From Baseline in the Medical Outcomes Study 6-Item Cognitive Functioning Scale (MOS-CF6) Total Score at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The MOS-CF 6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6-item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 is scored by summing responses across the 6 items and converting the total to a 0- to 100-point scale, with higher scores indicating better cognitive functioning. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Months 3, 6, 9, and 12 (or last postbaseline observation)|Changes from baseline in MOS-CF6 total score were not summarized. This assessment was not performed in study C10953/3067/ES/MN (NCT00893789); therefore, the data obtained at screening for the current study would represent true baseline data only for new participants, of which there were none.|||||
82292|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
82186|NCT00983437|Primary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set with a Baseline value; n=number of participants with baseline and postbaseline value at given time point.||units on a scale||Standard Deviation|Mean
82187|NCT00983437|Primary|"Number of Participants Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)"|The percentage of participants answering 'yes' to any of the 9 yes/no questions about suicidal behaviors, ideations, and acts at given time points are presented. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). Questions included the presence (yes) or absence (no) of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; n=number of participants with nonmissing value at given time point.||participants|||Number
82188|NCT00983437|Primary|Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT= head, eyes, ears, nose, throat. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint physical examination findings are summarized.||participants|||Number
82189|NCT00983437|Primary|Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint ECG findings are summarized.||participants|||Number
82190|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure ≥90 mm Hg plus increase of ≥10% from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; participants with a baseline and postbaseline value.||participants|||Number
82191|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results|Criteria for clinically significant abnormal urinalysis values: blood (hemoglobin) ≥2 unit increase from baseline; glucose ≥2 unit increase from baseline; ketones ≥2 unit increase from baseline; total protein ≥2 unit increase from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
82192|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results|Criteria for clinically significant abnormal hematology values: hematocrit, men <0.37 L/L or women <0.32 L/L; hemoglobin, men ≤115 g/L or women ≤95 g/L; white blood cell (WBC) count ≤3x10^9/L or ≥20x10^9/L; eosinophils ≥10%; absolute neutrophil count (ANC) ≤1x10^9/L; platelet count ≤75x10^9/L or ≥700x10^9/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
82212|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|"Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants.~Intention to Treat (ITT)."||units on a scale||Standard Deviation|Mean
82193|NCT00983437|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Score Values at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|"The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a true or not true answer. To score the questionnaire, the number of true responses is counted: if < 2, the risk for work instability is low; 2 to 23, the risk is medium; and >23, the risk is high. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability). Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Months 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Full Analysis Set (those in the Safety Analysis Set with at least 1 post-baseline efficacy assessment) with a TBI-WIS score at baseline; n=number of participants with value at baseline and given time point.||units on a scale||Standard Deviation|Mean
82194|NCT00983437|Secondary|Percentage of Participants With Improvement on the Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Improvement is defined as at least 1 point improvement from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.||percentage of participants|||Number
82195|NCT00983437|Secondary|Change From Baseline in Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.||units on a scale||Standard Deviation|Mean
82196|NCT00983437|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The participant's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.||units on a scale||Standard Deviation|Mean
82197|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements|Criteria for clinically significant abnormal vital signs values: pulse, ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm or ≤50 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure, ≥180 mm Hg and increase from baseline of ≥20 mm Hg or ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure, ≥105 mm Hg and increase from baseline of ≥15 mm Hg or ≤50 mm Hg and decrease from baseline of ≥15 mm Hg; temperature >38.3º celsius (C) and change from baseline of ≥1.1°C. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
82198|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results|Criteria for clinically significant abnormal serum chemistry values: alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN); aspartate aminotransferase (AST) ≥3x ULN; alkaline phosphatase ≥3x ULN; gamma-glutamyl transpeptidase (GGT) ≥3x ULN; lactate dehydrogenase (LDH) ≥3x ULN; blood urea nitrogen (BUN) ≥10.71 mmol/L; creatinine ≥177 μmol/L; uric acid, men ≥625 μmol/L, women ≥506 μmol/L; bilirubin (total) ≥34.2 μmol/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set who had a baseline and at least one post-baseline value.||participants|||Number
82199|NCT00983437|Primary|Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study|Therapeutic classification of concomitant medications used by participants throughout the study. Participants are counted only once in each therapeutic class category.|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set||participants|||Number
82597|NCT00979212|Secondary|Patterns of First Failure|The first failure site will be tabulated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|All eligible patients who started study treatment||participants|||Number
82200|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship to study drug. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis, and seizure or suspected seizure were considered to be of potential clinical importance. DB=double-blind portion of the study (NCT00893789).|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set (study participants who received at least 1 dose of study drug)||participants|||Number
82201|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 8 participants. Unclear and positive painDETECT subpopulation - 42 participants||Units on a scale||Standard Deviation|Mean
82202|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 13 participants. Unclear and positive painDETECT subpopulation - 62 participants||Units on a scale||Standard Deviation|Mean
82203|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 18 participants. Unclear and positive painDETECT subpopulation - 70 participants||Units on a scale||Standard Deviation|Mean
82204|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 15 participants. Unclear and positive painDETECT subpopulation - 24 participants||Units on a scale||Standard Deviation|Mean
82205|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 22 participants. Unclear and positive painDETECT subpopulation - 37 participants||Units on a scale||Standard Deviation|Mean
82206|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 31 participants. Unclear and positive painDETECT subpopulation - 56 participants||Units on a scale||Standard Deviation|Mean
82207|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 12|Intention to treat (ITT).||participants|||Number
82208|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 8|Intention to treat (ITT).||participants|||Number
82209|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 6|Intention to treat (ITT).||participants|||Number
82210|NCT00983385|Secondary|Participant's Satisfaction With Previous Analgesic Treatment at Baseline|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor.|Baseline|||participants|||Number
82211|NCT00983385|Secondary|Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.|Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial.|Week 6|Negative painDETECT subpopulation - 22 participants Unclear painDETECT subpopulation - 15 participants Positive painDETECT subpopulation - 22 participants Intention to treat (ITT).||milligrams (mg)||Standard Deviation|Mean
82236|NCT00983385|Primary|The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|Baseline; End of Week 6 (6 Weeks)|Intention to treat. Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
82213|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear or positive painDETEC subpopulation - 94 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
82214|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Depression Score at Baseline|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
82215|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
82216|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear and positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
82217|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Anxiety Score at Baseline|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).||units on a scale||Standard Deviation|Mean
82218|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Maintenance Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).||participants|||Number
82219|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT).||participants|||Number
82220|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 23 participants. Unclear and positive painDETECT subpopulation - 66 participants.||Units on a scale||Standard Deviation|Mean
82221|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). Unclear and positive painDETECT subpopulation - 66 participants. painDETECT negative subpopulation - 23 participants.||units on a scale||Standard Deviation|Mean
82222|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 34 participants. Unclear and positive painDETECT subpopulation - 97 participants.||Units on a scale||Standard Deviation|Mean
82347|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.||percentage of glycosylated haemoglobin||Standard Deviation|Mean
82223|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 35 participants. Unclear and positive painDETECT subpopulation - 98 participants.||Units on a scale||Standard Deviation|Mean
82224|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
82225|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
82226|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
82227|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 6|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
82228|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|Baseline Visit|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
82229|NCT00983385|Secondary|painDETECT Assessment for Participants at End of the Maintenance Period|"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
82230|NCT00983385|Secondary|painDETECT Assessment for Participants at End of Titration and Optimal Dose Period|"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
82231|NCT00983385|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).||units on a scale||Standard Deviation|Mean
82232|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 weeks)|||Units on a scale||Standard Deviation|Mean
82233|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
82234|NCT00983385|Secondary|Patient Global Impression of Change at End of the Maintenance Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).||participants|||Number
82235|NCT00983385|Secondary|Patient Global Impression of Change at End of Titration and Optimal Dose Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).||participants|||Number
82237|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration|||pg-hr/mL||Standard Deviation|Mean
82238|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration|||pg-hr/mL||Standard Deviation|Mean
82239|NCT00983372|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration|||pg/mL||Standard Deviation|Mean
82240|NCT00983359|Secondary|Karnofsky Decay Time|Time from enrollment to the date the patient’s Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient’s Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.|From time of enrollment up to 5 years|||months||Full Range|Median
82241|NCT00983359|Secondary|Time to Systemic Death|Descriptive analysis will be conducted using Kaplan-Meier survival analysis|From time of enrollment up to 5 years|||months||95% Confidence Interval|Median
82242|NCT00983359|Secondary|Time to Neurological Death|Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered ‘censored’ observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an ‘event’ or neurological death.|From time of enrollment up to 5 years|||months||Full Range|Median
82243|NCT00983359|Secondary|Progression-free Survival (PFS)|Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered ‘censored’. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.|Up to 5 years|||months||95% Confidence Interval|Median
82244|NCT00983359|Primary|Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status|Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.|Up to 5 years|||patients|||Number
82245|NCT00983346|Primary|Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.|The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.|Baseline and 6 weeks|Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study||Percentage of Baseline Value|||Number
82246|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82247|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82248|NCT00983294|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
82249|NCT00983281|Primary|Mortality||Overall inpatient mortality upon discharge from the hospital|||participants|||Number
82250|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.|||pg-hr/mL||Standard Deviation|Mean
82251|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.|||pg-hr/mL||Standard Deviation|Mean
82252|NCT00983242|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.|||pg/mL||Standard Deviation|Mean
82253|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82254|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration|||pg-hr/mL||Standard Deviation|Mean
82255|NCT00983216|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration|||pg/mL||Standard Deviation|Mean
82256|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||units on a scale||Standard Deviation|Mean
82257|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||units on a scale||Standard Deviation|Mean
82258|NCT00983073|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Number of participants with data available||units on a scale||Standard Deviation|Mean
82259|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||participants|||Number
82260|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||participants|||Number
82261|NCT00983073|Secondary|Participant's Satisfaction With Previous Analgesic Treatment|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Number of participants with data available.||participants|||Number
82262|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||Participants|||Number
82263|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||Participants|||Number
82264|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||Participants|||Number
82265|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available||Participants|||Number
82266|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline, End of Week 12 (12 Weeks)|Number of participants with data available||Units on a scale||Standard Deviation|Mean
83354|NCT00973700|Secondary|HI GMRs, in 3 to <9 Years and 9 to 17 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).~The analyses were performed on the the per-protocol set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.||Ratio||95% Confidence Interval|Geometric Mean
82267|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.||Units on a scale||Standard Deviation|Mean
82268|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available||Units on a scale||Standard Deviation|Mean
82269|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.||Units on a scale||Standard Deviation|Mean
82270|NCT00983073|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available.||units on a scale||Standard Deviation|Mean
82271|NCT00983073|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.||units on a scale||Standard Deviation|Mean
82272|NCT00983073|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS)where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|||units on a scale||Standard Deviation|Mean
82273|NCT00983073|Primary|The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline to end of week 6|All participants who had at least one dose of study medication and one post-baseline pain intensity assessment. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
82274|NCT00982995|Secondary|To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.|||||
82275|NCT00982995|Primary|To Determine the Complete Response (no Vomiting and no Need for Nausea Rescue Medication) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron.||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.|||||
82276|NCT00982735|Secondary|Change From Baseline in Microalbuminuria at 24 Weeks||Baseline and 24 weeks|||Participants|||Number
82277|NCT00982735|Secondary|Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion|A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).|24 weeks|||Participants|||Number
82278|NCT00982735|Primary|Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.||24 weeks|||Participants|||Number
82279|NCT00982657|Secondary|Number of Participants With Anti- CVX-060 Antibodies||Baseline up to 28 days after last CVX-060 dose|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, no Anti-CVX-060 antibody assessment was conducted.|||||
82280|NCT00982657|Secondary|Duration of Response|Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.|Baseline up to 7 days post last dose of study medication|Duration of response was not calculated as there were no participants with objective response.|||||
82291|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 126 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
82281|NCT00982657|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|Baseline up to 7 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||Percentage of participants||95% Confidence Interval|Number
82282|NCT00982657|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.||Participants|||Number
82283|NCT00982657|Secondary|Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels||Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, pharmacodynamics assessment was not conducted.|||||
82284|NCT00982657|Secondary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.||participants|||Number
82285|NCT00982657|Secondary|Pharmacokinetic Parameters of CVX-060|Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.|Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study,pharmacokinetics assessment was not conducted.|||||
82286|NCT00982657|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.|Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study.The PFS endpoint was a pre-specified endpoint for the Phase II portion of the study, and was therefore not assessed.|||||
82287|NCT00982657|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.|Baseline up to Cycle 1( Day 1 to Day 42)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study, no MTD was assessed.|||||
82288|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days of follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Events/100 years of patient exposure|||Number
82289|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
82290|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104|Mean of 9-point SMPG at 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 140 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
82293|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
82294|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
82295|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
82296|NCT00982644|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
82297|NCT00982592|Secondary|Incidence of Toxicities (grades1 and 2)|Defined as percentage of patients who experienced a toxicity with grade 1 or 2 (worst grade) related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|Up to 4 years|All the patients who started the treatment.||percentage of patients|||Number
82298|NCT00982592|Secondary|Incidence of Toxicities (Grade 3 and Higher)|Defined as percentage of patients who experienced a toxicity with grade 3 or higher related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0|Up to 4 years|All the patients who started the treatment.||percentage of patients|||Number
82299|NCT00982592|Secondary|Overall Survival|Defined as time from randomization day until death from any cause.|up to 4 years|Intent-to-treat population||months||95% Confidence Interval|Median
82300|NCT00982592|Secondary|Objective Response Rate|Defined as the percentage of the patients who had complete response (CR) or partial response (PR) per RECIST 1.1.|Up to 4 years|Intent-to-treat population||percentage of patients|||Number
82301|NCT00982592|Primary|Median Progression-free Survival (PFS)|PFS is defined as the time from randomization until objective tumor progression or death from any cause and is evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|up to 4 years|Intent-to-treat population||months||95% Confidence Interval|Median
82302|NCT00982553|Primary|Raltegravir Maximum Plasma Concentrations When Co-administered|On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.|Day 20|||ng/mL||95% Confidence Interval|Geometric Mean
82303|NCT00982553|Primary|Ribavirin Maximum Plasma Concentration When Co-administered|On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.|Day 20|||ng/mL||95% Confidence Interval|Geometric Mean
82304|NCT00982553|Primary|Raltegravir Alone Maximum Plasma Concentration|After a 14 day wash out participants took raltegravir 400 mg twice daily for 4 days. on day 19 they attended for intensive pharmacokinetic tests at 0 (pre-dose of raltegravir 400mg)then 0.5, 1, 2, 3, 4, 6, 8 and 12 hours|Day 19|||ng/mL||95% Confidence Interval|Geometric Mean
82305|NCT00982553|Primary|Ribavirin Alone Maximum Plasma Concentration|On day 1 participants were administered a single dose of Ribavirin 800mg and then intensive pharmacokinetic blood samples were collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours|Day 1|Per protocol||ng/mL||95% Confidence Interval|Geometric Mean
82306|NCT00982488|Primary|Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment through a maximum of 82 months + 30 days|All participants who received at least 1 dose of study drug||Participants|||Number
82307|NCT00982423|Secondary|Plasma Cyclic Guanosine Monophosphate (cGMP) at Baseline and in Response to Decreasing Furosemide Dose|Any change in atrial filling pressures leads to the release of atrial natriuretic peptides (ANP) from the heart. Once released, atrial peptides exert potent direct vasodilator and natriuretic actions by virtue of the ability to increase their intracellular second messenger, cGMP. Plasma cGMP correlates closely with the severity of congestive heart failure.|3 weeks, approximately 6 weeks|||pg/mL||Standard Deviation|Mean
83428|NCT00972543|Secondary|Haematology Laboratory Assessments - Basophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
82308|NCT00982423|Secondary|Angiotensin II at Baseline and in Response to Decreasing Furosemide Dose|Renin activates the renin-angiotensin system by cleaving angiotensinogen, produced by the liver, to yield angiotensin I, which is further converted into angiotensin II by the angiotensin-converting enzyme (ACE) primarily within the capillaries of the lungs. Angiotensin II then constricts blood vessels, increases the secretion of antidiuretic hormone (ADH) and aldosterone, and stimulates the hypothalamus to activate the thirst reflex, each leading to an increase in blood pressure.|3 weeks, approximately 6 weeks|||pg/mL||Standard Deviation|Mean
82309|NCT00982423|Secondary|Plasma Renin Activity at Baseline and in Response to Decreasing Furosemide Dose|Plasma renin activity is a measure of the activity of the plasma enzyme renin, which plays a major role in the body's regulation of blood pressure, thirst, and urine output. Renin is an enzyme that hydrolyses angiotensinogen secreted from the liver into the peptide angiotensin I. Renin's primary function is to cause an increase in blood pressure, leading to restoration of perfusion pressure in the kidneys.|3 weeks, approximately 6 weeks|||ng/mL/hr||Standard Deviation|Mean
82310|NCT00982423|Secondary|Aldosterone at Baseline and in Response to Decreasing Furosemide Dose|Aldosterone is part of the renin–angiotensin-aldosterone system (RAAS). Drugs that interfere with the secretion or action of aldosterone are in use as antihypertensives, like lisinopril, which lowers blood pressure by blocking the angiotensin-converting enzyme (ACE), leading to lower aldosterone secretion. The net effect of these drugs is to reduce sodium and water retention but increase retention of potassium.|3 weeks, approximately 6 weeks|||ng/dL||Standard Deviation|Mean
82311|NCT00982423|Secondary|Renal Plasma Flow at Baseline and in Response to Decreasing Furosemide Dose|Effective renal plasma flow (eRPF) is a measure used to calculate renal plasma flow (RPF) and hence estimate renal function. Renal plasma flow is the volume of blood plasma that flows through the kidneys per unit time, measured as ml/min.|3 weeks, approximately 6 weeks|||ml/min||Standard Deviation|Mean
82312|NCT00982423|Primary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at Baseline and in Response to Decreasing Furosemide Dose|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|3 weeks, approximately 6 weeks|||ml/min||Standard Deviation|Mean
82313|NCT00982410|Secondary|As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. The outcome measure below represents the average WHY MPI General Activity score in each Arm/Group, across the entire follow-up period, adjusted for baseline WHY MPI General Activity score, but restricted here to study participants that partook in at least one treatment group session.|Baseline, 3mo, 6mo, 12mo follow-up|||units on a scale||Standard Error|Mean
82314|NCT00982410|Secondary|As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|Per study protocol, participants were asked to attend 10 sessions, which comprised the intervention for CBT participants and educational support for EUC participants. Some participants in each group did not attend any sessions, yet participated in follow-up assessments. The As-treated analysis was undertaken to evaluate the impact of the intervention, among participants that attended at least 1 session. As in the Primary Analysis, average pain last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation|Baseline, 3-, 6-, 12-months|||units on a scale||Standard Error|Mean
82315|NCT00982410|Secondary|Self-efficacy of Physical Functioning|The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS subscale, self-efficacy for physical function (FSE), utilized to assess management of pain-related disability, with respect to several aspects of daily functioning. This scale have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS FSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of CPSS FSE.|Baseline, 3-, 6-, 12- months|||units on a scale||Standard Error|Mean
82316|NCT00982410|Secondary|Self-efficacy of Pain Management|As measured via CPSS PSE score at each time point. The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS PSE subscale is a measure of self-efficacy for pain management. These scales have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS PSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline CPSS PSE.|Baseline, 3-, 6-, 12- months|||units on a scale||Standard Error|Mean
82317|NCT00982410|Primary|Pain Tolerance|Pain tolerance was measured by the amount of time the participant could hold their hand immersed in a vessel of cold water in seconds. The maximum allowed duration of the test was two minutes. The outcome measure below represents the average duration of task in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of pain tolerance.|Baseline, 3-,6-,12-months|||seconds||Standard Error|Mean
82318|NCT00982410|Primary|Drug Use|# days used illicit drugs in the past 30 days, as assessed via timeline follow-back (TLFB) calendars. Use of illicit drugs and misuse of prescription drugs (e.g., Rx opioids) were recorded for the 30 days prior to the follow-up visit. #days in a controlled environment (e.g., hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days drug use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used illicit drugs.|Baseline, 3-, 6-, 12- months|||#Days used||Standard Error|Mean
82319|NCT00982410|Primary|Alcohol Use|#days used alcohol in the past 30 days, as assessed via timeline follow-back(TLFB) calendars. #days in a controlled environment (e.g. hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days alcohol use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used alcohol.|Baseline, 3-, 6-, 12- months|||#Days used||Standard Error|Mean
82320|NCT00982410|Primary|The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. Aspects include ability to perform chores inside the home, activities away from the home, and social functioning. The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period, and was adjusted for baseline WHY MPI General Activity score.|Baseline, 3-,6-, 12-month|||units on a scale||Standard Error|Mean
82321|NCT00982410|Primary|Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period. Average pain in the last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation.|Baseline, 3-, 6-, & 12-months|||units on a scale||Standard Error|Mean
82322|NCT00982345|Primary|17-item Hamilton Depression Rating Scale (HDRS)|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|Started: March 2009 Ending March 2011|||units on a scale||Standard Deviation|Mean
82323|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 6 participants with previous oxycodone treatment.||Ratio|||Number
82324|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Transdermal Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Transdermal Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 48 participants with previous transdermal buprenorphine treatment.||Ratio|||Number
82325|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 12 weeks|Intention to treat (ITT).||participants|||Number
82326|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 6 weeks|Intention to treat (ITT).||participants|||Number
82327|NCT00982280|Secondary|Participant's Satisfaction With Previous Analgesic Treatment.|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Intention to treat (ITT).||participants|||Number
82328|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).||participants|||Number
82329|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).||participants|||Number
82330|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).||participants|||Number
82331|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).||participants|||Number
82332|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|12 Weeks|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
82333|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|6 Weeks|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
82334|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|12 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Median
82335|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|6 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Median
82336|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|12 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Mean
82337|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|6 weeks|Intention to treat (ITT).||Units on a scale||Standard Deviation|Mean
82338|NCT00982280|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Intention to treat (ITT).||Units on a scale||Standard Deviation|Mean
82339|NCT00982280|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 12 (12 weeks)|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
82340|NCT00982280|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 6 (6 weeks)|Intention to treat||Units on a scale||Standard Deviation|Mean
82341|NCT00982280|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat||units on a scale||Standard Deviation|Mean
82342|NCT00982280|Primary|Responder Rate|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period after 6 weeks of tapentadol PR treatment as with their previous analgesic treatment.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).||Participants|||Number
82343|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 7 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
82344|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
82345|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
82346|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment|Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Treatment week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 12 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
82348|NCT00982228|Primary|Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin|The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.|Week 0, Week 106|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||%B/T||Standard Deviation|Mean
82349|NCT00982228|Secondary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
82350|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
82351|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Events/100 years of patient exposure|||Number
82352|NCT00982228|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using LOCF (last observation carried forward).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
82353|NCT00982189|Secondary|Changes in Biomarkers|The biomarkers assessed in this study were soluble proteins measured in blood, or the plasma component of blood. The biomarkers measured represent inflammation and activation of the immune system in the body.|change from baseline to 4 months||||||
82354|NCT00982189|Secondary|Changes in Small Artery Elasticity|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|change from baseline to 4 months||||||
82355|NCT00982189|Secondary|Changes in Blood Lipids|Blood lipids include routine cholesterol measurements that are monitored in clinical practice. They are measured in blood after a blood draw is performed. The specific measurements include: a) total cholesterol, b) low-density lipoprotein cholesterol, c) high-density lipoprotein cholesterol, and d) triglycerides|change from baseline to 4 months||||||
82356|NCT00982189|Secondary|Changes in Blood Pressure|Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)|change from baseline to 4 months||||||
82357|NCT00982189|Primary|Change From Baseline to Month 4 in the Framingham Risk Score (FRS)|The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)|Change from baseline to 4 months|All participants had Framingham risk score (FRS) estimated at baseline and month 4. The change from baseline to month 4 was calculated as the outcome.||Percent probability of CHD event in 10yr||Inter-Quartile Range|Median
82358|NCT00982189|Primary|Number of Participants Who Took >90% of Their Doses (by Pill Count)|The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'|4 months|Number of participants who took >90% of their doses (by pill count)were studied. All participants who returned unused medications at end of the study were included for these analyses||participants|||Number
82359|NCT00982189|Primary|Number of Participants Who Stated (by Self-report) That They Had Side Effects|Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.|4 months|Number of participants who stated (by self-report) that they had side effects||participants|||Number
82377|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants|The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.|Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
82360|NCT00982137|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain.~All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups."|Day 0 up to Day 60 post-vaccination|Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population).||Participants|||Number
82361|NCT00982137|Primary|Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination|Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.|Day 0 (Pre-vaccination) through Day 30 post-vaccination|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).||Participants|||Number
82362|NCT00982137|Secondary|Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.~Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
82363|NCT00982137|Secondary|Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.~Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)"|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population).||Titers||95% Confidence Interval|Geometric Mean
82364|NCT00982137|Primary|Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.|"Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples.~The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).||Participants|||Number
82365|NCT00982137|Primary|Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.~The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).||Participants|||Number
82366|NCT00982111|Secondary|Percentage of Participants With EGFR Measured by IHC|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment||percentage of participants|||Number
82378|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug.||centimeters (cm)||Standard Error|Least Squares Mean
83429|NCT00972543|Secondary|Haematology Laboratory Assessments - Eosinophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
82367|NCT00982111|Secondary|Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.||H-Score||Standard Deviation|Mean
82368|NCT00982111|Secondary|Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle =3 Weeks)|All randomized participants who had evaluable baseline and postbaseline LCSS data.||millimeter (mm)||Standard Deviation|Mean
82369|NCT00982111|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.||units on a scale||Standard Deviation|Mean
82370|NCT00982111|Secondary|Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline to Study Completion (Up to 31.6 Months)|All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.||participants|||Number
82371|NCT00982111|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks|Participants who were randomized to necitumumab and had evaluable PK data.||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
82372|NCT00982111|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.|Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13||Months||95% Confidence Interval|Median
82373|NCT00982111|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 30.4 Months)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
82374|NCT00982111|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79||Months||95% Confidence Interval|Median
82375|NCT00982111|Primary|Overall Survival Time (OS)|OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31.6 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72||Months||95% Confidence Interval|Median
82376|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline, 52 weeks|All randomized participants with schizophrenia who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
82379|NCT00982020|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants|The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).|52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
82380|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).|Baseline, 52 weeks|All randomized participants with bipolar I disorder, who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.||units on a scale||Standard Error|Least Squares Mean
82381|NCT00982020|Secondary|Time to Event for 7%, 15%, and 25% Weight Gain for All Participants|Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).|Baseline up to 52 weeks|"65 participants (32%; 34% in Standard Group [SG], 30% in Intense Group [IG]) did not meet 7% weight gain criterion [WGC] by the time they discontinued.~122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued.~161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued."||days||95% Confidence Interval|Median
82382|NCT00982020|Secondary|Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug and who had at least 6 months of data. Last observation carried forward (LOCF) methodology.||kg/m^2||Standard Error|Least Squares Mean
82383|NCT00982020|Primary|Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used.||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
82384|NCT00982007|Primary|Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.||Day 35|Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment||g/dL||Standard Deviation|Mean
82385|NCT00981825|Primary|CFU (Colony Forming Units)|Total number of salivary bacterial colony forming units (lower number = less colonies present)|4 hours|||number of colony forming units||Standard Deviation|Mean
82386|NCT00981812|Primary|Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.||At time of biopsy|||Breast Lesions|||Number
82387|NCT00981669|Primary|Number of Participants With Adverse Events.|Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.|Within the first five days post-vaccination.|||participants|||Number
82388|NCT00981669|Secondary|Anti-rotavirus IgA Level.|It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.|before each dose (total of doses:3) and after 6 weeks of the third dose|As in most phase I trials, sample size was not calculated to provide statistically significant differences between groups. Rather, a descriptive analysis on the frequency of AE and immunogenicity data was undertaken.||Arbitrary units||Inter-Quartile Range|Median
82389|NCT00981630|Secondary|Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer < 1:10.|Day 30 up to 12 months post-vaccination|Seropositivity was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).||Participants|||Number
82390|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.|Day 30 post-vaccination|Geometric mean titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
82391|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.|Day 11 and Day 30 post-vaccination|Geometric Mean Titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
82392|NCT00981630|Primary|Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.|Day 0 (post-vaccination) up to Day 30 post-vaccination|Adverse events were assessed in all randomized participants who received one injection of study treatment, according to the treatment actually received (Safety Population).||Participants|||Number
82393|NCT00981630|Primary|Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.||Participants|||Number
82394|NCT00981630|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 11 and Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.||Participants|||Number
82395|NCT00981461|Primary|Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks|||hairs per cm^2||Standard Deviation|Mean
82396|NCT00981409|Secondary|The Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|FPX or UFH treatment period (Days 5-10, on average)|Safety population: all participants who received at least one dose of medication (FPX or UFH).||percentage of participants|||Number
82397|NCT00981409|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10|The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||points on a scale||Standard Deviation|Mean
82398|NCT00981409|Secondary|The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse|"Improved, No change, or Worse was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE."|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||percentage of participants|||Number
82399|NCT00981409|Secondary|The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||percentage of participants|||Number
82400|NCT00981409|Primary|The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)||percentage of participants|||Number
82401|NCT00981370|Primary|To Determine if Red Cell Survival as Assessed by Hemoglobin Level, Reticulocyte Count, Lactic Acid Dehydrogenase, and Plasma Hemoglobin in Sickle Cell Patients is Related to the Degree of Iron Overload||Baseline, 6 months and 12 months||||||
82402|NCT00981305|Secondary|Change of Vaginal Maturation Index|Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
82403|NCT00981305|Secondary|Change of Vaginal pH||Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
82404|NCT00981305|Secondary|Change of a Total and Other Five Domains of Female Sexual Function Index Score|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
82430|NCT00981084|Primary|CPT -Test of Information Processing Speed|"Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores.~Continuous Performance Test (CPT) - Vigilance and reaction time."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||milliseconds||Standard Deviation|Mean
82405|NCT00981305|Primary|Change of Pain Score of Female Sexual Function Index|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
82406|NCT00981292|Secondary|Number of Participants With Significant Modulation of Mood.|Mood was assessed via computerised visual analogue scales at baseline and post- dose time points. Mood scores were calculated as change from baseline. And significant modulation was determined if baseline scores were significantly different to post dose.|42 minutes|As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis.||Participants|||Number
82407|NCT00981292|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|The cognitive performance of participants was assessed via a range of computerised, mentally demanding, executive function tasks: Serial 3s and 7s subtractions, oddball reaction time task, rapid visual information processing, stroop and simple reaction time.These tasks were completed at baseline and then again 45 minutes after treatment administration. Significant modulation was determined if participants' post dose scores were significantly higher than baseline.|42 minutes|If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis.||Participants|||Number
82408|NCT00981292|Primary|Modulation of Levels of Total Haemoglobin|This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.|42 minutes|If NIRS readings were deemed not too affected by artefacts (usually caused by participants moving the headband in some way) then they were utilized in the analysis.||μmol/L||Standard Error|Mean
82409|NCT00981227|Other Pre-specified|Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose|Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11–point (0 “no pain” to 10 “worst possible pain”) NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject’s mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject’s NRPS use during site initiation visits and at the investigators’ meeting.|baseline and 13 weeks|||Points||Standard Error|Least Squares Mean
82410|NCT00981227|Primary|Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain|"The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours.~Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows:~Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation.~Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period."|baseline and 13 weeks|||Points||Standard Error|Least Squares Mean
82411|NCT00981214|Secondary|Percentage of Stool With Visible Oil or Grease|Mean percentage of oil or grease at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||percentage of oil/grease||Standard Deviation|Mean
82412|NCT00981214|Secondary|Percentage of Blood in Stool|Mean percentage of stools with blood at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.||percentage of blood||Standard Deviation|Mean
82413|NCT00981214|Secondary|Physician’s and Parent’s or Legal Guardians Assessment of Improvement in Clinical Symptoms|Clinical symptoms of exocrine pancreatic insufficiency (EPI) were assessed by the physician and parent or guardian to determine if the participant showed improvement in symptoms of EPI at end of study after the dose stabilization period. EPI is a syndrome characterized by clinical symptoms of poor absorption of fats, proteins, and to a lesser extent, carbohydrates, which manifests primarily in patients with cystic fibrosis. Number of participants with improvement in clinical symptoms was reported.|Day 19 (end of study)|Analysis population set included all participants who received at least 1 dose of study.||participants|||Number
82414|NCT00981214|Secondary|Mean Number of Pain Symptoms|Symptoms of pain was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.||pain symptoms per day||Standard Deviation|Mean
82415|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||flatulences per day||Standard Deviation|Mean
82441|NCT00981045|Primary|Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.|The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.|Day 120|||participants|||Number
82416|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||bloatings per day||Standard Deviation|Mean
82417|NCT00981214|Secondary|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery or overt diarrhea. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period) and Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||percentage of stools||Standard Deviation|Mean
82418|NCT00981214|Primary|Percentage of Participants Who Were Responders After 2 Weeks of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30% fecal fat content) and without signs and symptoms of malabsorption after 2 weeks of treatment with study medication.|Day 18 (end of treatment)|Analysis population included all participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
82419|NCT00981214|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.||stools per day||Standard Error|Mean
82420|NCT00981214|Secondary|Change From Baseline in Weight at Day 12, 19||Baseline, Day 12, 19|Analysis population included all participants who received at least 1 dose of study medication.||kilogram||Standard Deviation|Mean
82421|NCT00981214|Primary|Percentage of Participants Who Were Responders After 1 Week of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.|Day 11|Analysis population included all participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
82422|NCT00981175|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.|Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.|Day 0 up to 28 post-vaccination|Treatment emergent adverse events were assessed in the Safety Population.||Participants|||Number
82423|NCT00981175|Primary|Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.|Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.|Days 0 to 28 post-vaccination|Injection site reactions were assessed in the Safety Population.||Participants|||Number
82424|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.|Month 24 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population||Participants|||Number
82425|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.|Month 12 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population||Participants|||Number
82426|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.|Month 6 pre- and post-vaccination|Immunogenicity was assessed in the Intent to Treat Population pre- and post-booster vaccination.||Participants|||Number
82427|NCT00981175|Primary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.|Day 28 post-vaccination|Immunogenicity was assessed in the Intent-to-Treat Population.||Participants|||Number
82428|NCT00981084|Primary|Word Generation|Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||number of words generated||Standard Deviation|Mean
82429|NCT00981084|Primary|Stroop|Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||number of colors named||Standard Deviation|Mean
82442|NCT00981045|Primary|Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.||Day 56|||g/dL||Standard Deviation|Mean
82431|NCT00981084|Primary|Learning and Memory Measures.|"Testing was completed after first intervention and again after second intervention.~Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.~Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75).~RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15).~Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36).~BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12)."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.|||Items recalled||Standard Deviation|Mean
82432|NCT00981058|Secondary|Number of Participants With a Serum Anti-Necitumumab Antibody Assessment|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.|Baseline through 31 Months|All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.||participants|||Number
82433|NCT00981058|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months|All randomized participants who received at least one dose of study drug and had evaluable data for PK.||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
82434|NCT00981058|Secondary|Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of <200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|31 Months|All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.||participants|||Number
82435|NCT00981058|Secondary|Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable data for LCSS.||millimeter (mm)||Standard Deviation|Mean
82436|NCT00981058|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.||units on a scale||Standard Deviation|Mean
82437|NCT00981058|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.|Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 16, Gemcitabine + Cisplatin =20||Months||95% Confidence Interval|Median
82438|NCT00981058|Secondary|Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a >=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 31 Months)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
82439|NCT00981058|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131||months||95% Confidence Interval|Median
82440|NCT00981058|Primary|Overall Survival Time (OS)|Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 127, Gemcitabine + Cisplatin = 106||Months||95% Confidence Interval|Median
82443|NCT00981019|Secondary|Number of Physicians (= Participants) Assuming a Benefit of Screening|Physicians are faced with four different medical statistics about the effect of screening (e.g., 5-year survival) within four successive scenarios and after each scenario asked whether they assume the screening to be beneficial given the statistical information. Options to answer are: yes, no, can't decide. If yes, then participants are further asked to describe this benefit by the following categories: Very large, large, moderate, small, very small.|25 minutes (mean duration of the survey)||08/2011||||
82444|NCT00981019|Primary|Number of Physicians (=Participants) Recommending the Screening|The aim of the study was to learn how different medical cancer screening statistics would influence doctors' recommendation behavior and their effectiveness judgments of screening tests. For that reason the online survey study presented physicians with four different medical statistics (e.g., 5-year survival) within four successive scenarios and asked after each scenario whether they would recommend the screening to a (hypothetical) patient given the data. Options to answer are: Definitely yes, Probably yes, Probably no, Definitely no, Can’t decide.|25 minutes (mean duration of the survey)|We calculated that a sample size of 300 physicians was needed to have 90% power to detect differences of 20% or higher in the proportion of respondents correctly answering questions about the different cancer statistics (2-sided alpha of .05).||participants|||Number
82445|NCT00980980|Secondary|Intervention Impact on Chlorhexidine and Mupirocin Susceptibility of MRSA Isolates||TBD||10/2016||||
82446|NCT00980980|Secondary|Intervention Impact on Bacteriuria and Candiduria|Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL.|30-month time frame represents 12-month baseline and 18-month intervention periods.|The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm.||Hazard Ratio||95% Confidence Interval|Number
82447|NCT00980980|Secondary|Blood Culture Contamination Rates|Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.|24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.|The number of participants analyzed reflects the combined total of baseline and intervention admissions, with an ICU stay and a blood draw set, for each arm.||Odds Ratio||95% Confidence Interval|Number
82448|NCT00980980|Secondary|Intervention Impact on Healthcare Costs|Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).|12-month period|Annual adult ICU admissions per hospital, over the course of 1 year.||Dollars per 1000 ICU-admissions|||Number
82449|NCT00980980|Secondary|ICU-attributable All-pathogen Bloodstream Infection|Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.||Hazard ratio||95% Confidence Interval|Number
82450|NCT00980980|Secondary|MRSA Bloodstream Infection|Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.||hazard ratio||95% Confidence Interval|Number
82451|NCT00980980|Primary|Main Outcome: Patients With Nosocomial MRSA Clinical Cultures|Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.||hazard ratio||95% Confidence Interval|Number
82452|NCT00980798|Secondary|The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event|The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.|At each study visit from baseline until week 16|Safety population: All randomised patients who received at least one dose of study drug.||participants|||Number
82453|NCT00980798|Primary|Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)|"The analgesic effect was assessed by the BPI item 5 “pain on average” using a 0 to 10 numeric rating scale, with 0 being no pain and 10 being pain as bad as you can imagine."|At each study visit from screening to week 16|The primary population for the efficacy analyses was the intention to treat (ITT) population: all randomised patients who received at least one dose of study drug excluding patients who had no post-baseline efficacy data. This population included patients who discontinued early owing to lack of efficacy or other reasons.||units on a scale||Standard Deviation|Mean
82454|NCT00980746|Primary|Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain|﻿Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.|17 weeks|||units on a scale||Standard Error|Least Squares Mean
82455|NCT00980681|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared|1 to 7 days|||percentage of non-assessable segments|||Number
82484|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of <25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82456|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82457|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82458|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82459|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82460|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82461|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82503|NCT00980044|Primary|Subjective Opioid Withdrawal Adjective Total Score Week 2|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present|days 8-13|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean total withdrawal score across the days listed.||units on a scale||Standard Error|Mean
82462|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82463|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
82464|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.|1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
82465|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
82466|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||fold rise||95% Confidence Interval|Geometric Mean
82467|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||mcg/mL||95% Confidence Interval|Geometric Mean
82468|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
82469|NCT00980655|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.||fold rise||95% Confidence Interval|Geometric Mean
82470|NCT00980590|Secondary|Incidence of Intubation Complications|Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation|Intubation period|||cases|||Number
82471|NCT00980590|Secondary|Number of Intubation Attempts||Intubation period|||times|||Number
82472|NCT00980590|Secondary|Overall Intubation Success Rate||Intubation period|||Percentage of overall intubation|||Number
82473|NCT00980590|Primary|Intubation Time|For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time.|The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.|Patients with number of intubation attempt no more than 3||seconds||Standard Deviation|Mean
82474|NCT00980330|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each TMC435 treatment group.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng.h/mL||Full Range|Median
82475|NCT00980330|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for TMC435 for participants in each of the 6 TMC435 treatment groups.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng/mL||Full Range|Median
82476|NCT00980330|Secondary|The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82477|NCT00980330|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.|Up to Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82478|NCT00980330|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of > 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82479|NCT00980330|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.|Week 60|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82480|NCT00980330|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma levels of Hepatitis C virus ribonucleic acid at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82481|NCT00980330|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82482|NCT00980330|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.|Week 4|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82483|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of Participants|||Number
82485|NCT00980330|Secondary|The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment|The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.|Weeks, 2, 4, 8, and 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82486|NCT00980330|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)|The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.|Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.||Percentage of participants|||Number
82487|NCT00980278|Secondary|Final Bone Volume: Initial Graft Volume Ratio|Bone volume fraction of bone core histological and µCT analyses|4 months|||ratio||Standard Deviation|Mean
82488|NCT00980278|Secondary|Change in Sinus Bone Volume|CBCT was used to evaluated 3-D changes in the bone volume within the treated areas of the sinus cavity|Pre-baseline and within 2 weeks of 4 Month visit|||cm3||Standard Deviation|Mean
82489|NCT00980278|Primary|Bone Volume Fraction of Bone Core|Bone volume fraction of bone core histological and µCT analyses|4 months|||ratio||Standard Deviation|Mean
82490|NCT00980278|Secondary|Change in Linear Radiographic Bone Height|Change in linear radiographic bone heights were measured before and after bone graft reconstruction|Screening and 1 week post-op from baseline|||mm||Standard Deviation|Mean
82491|NCT00980278|Primary|Bone Mineral Density of Bone Core|Bone mineral density of bone core was measured by histological and µCT analyses|4 months|||mg/mm^3||Standard Deviation|Mean
82492|NCT00980200|Secondary|Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean was derived by calculating the average area under curve, and then dividing by the relevant time interval. 24-hour serial measurements of FEV1 were performed on Day 7 of each of the 5 treatment periods (Visits 3, 5, 7, 9, and 11). Measurements were taken at pre-dose; 30 and 60 minutes; and 3, 5, 11, 12, 12.5, 13, 15, 17, 23, and 24 hours post-dose. Visits 3, 5, 7, 9, and 11 were overnight visits. Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed effects analysis of covariance (ANCOVA) model, with fixed effects for treatment, period, sex, and age. Participant was fitted as a random effect, and the period Baseline FEV1 measurement was included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
82493|NCT00980200|Primary|Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|Intent-to Treat (ITT) Population: all participants randomized to treatment who received at least one dose of trial medication. Randomized participants were assumed to have received trial medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
82494|NCT00980174|Secondary|Serum Type 1 Collagen C-telopeptide (CTX) Percent Change From Baseline at Day 15||From Baseline to Day 15|||Percent||Inter-Quartile Range|Median
82495|NCT00980174|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
82496|NCT00980174|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
82497|NCT00980174|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
82498|NCT00980174|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|||Percent||95% Confidence Interval|Mean
82499|NCT00980174|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|Subjects with baseline and at least one post baseline measurements||Percent||95% Confidence Interval|Mean
82500|NCT00980148|Secondary|Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.||Baseline and study visit #2 (Day 28 after therapy is started)||||||
82501|NCT00980148|Primary|Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.|The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).|Study visit # 2 (Day 28 after therapy started)|The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.||percentage of participants|||Number
82502|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 8-13 (all groups now on placebo)|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean number of doses/day across the days listed.||mean # of doses per day||Standard Error|Mean
82504|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 1-7|These are data from week 1 -- the 12 people who completed this week in each group. This is the analysis that was specified at the start of the study. The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.||Mean doses per day||Standard Error|Mean
82505|NCT00980044|Primary|Subjective Opioid Withdrawal Total Adjective Score|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T|Days 1-7|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.||units on a scale||Standard Error|Mean
82506|NCT00980005|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82507|NCT00980005|Secondary|Number of Subjects Reporting Medically Attended Adverse Events (MAEs).|For each solicited and unsolicited symptom the subject experiences, the subject/subject’s parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82508|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.~Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82509|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82510|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.|"Solicited local symptoms assessed were pain, redness and swelling.~Any = occurrence of any solicited general symptom regardless of intensity grade.~Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm).~All solicited local AEs were considered to be causally related to vaccination.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82511|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|"Solicited local symptoms assessed were pain, redness and swelling.~Any = occurrence of any solicited general symptom regardless of intensity grade.~Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm).~All solicited local AEs were considered to be causally related to vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82512|NCT00980005|Secondary|Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).~Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.~Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.~Related = symptom assessed by the investigator as causaly related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82513|NCT00980005|Secondary|Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).~Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.~Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.~Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.~Related = symptom assessed by the investigator as causally related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.||Subjects|||Number
82524|NCT00979901|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2|Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no baseline or treatment period data were available. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
82514|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.~Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Fold increase||95% Confidence Interval|Mean
82515|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.~Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Fold increase||95% Confidence Interval|Mean
82516|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
82517|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
82518|NCT00980005|Secondary|Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
82519|NCT00980005|Secondary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs).~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Titers||95% Confidence Interval|Geometric Mean
82520|NCT00980005|Primary|Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Subjects|||Number
82521|NCT00980005|Primary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.||Titers||95% Confidence Interval|Geometric Mean
82522|NCT00979953|Primary|Change From Baseline in the Average Pain Score (NPRS) for Week 2|The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.|Baseline, Week 2|All participants who received at least 1 dose of study medication and had at least evaluable 1 NPRS postdose measurement. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.||units on a scale||Standard Deviation|Least Squares Mean
82523|NCT00979940|Primary|Periprocedural Myonecrosis||16-24 hours post PCI|||participants|||Number
82525|NCT00979901|Secondary|Physician's Global Evaluation of Allergic Rhinitis at Week 2|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
82526|NCT00979901|Secondary|Patient's Global Evaluation of Allergic Rhinitis at Week 2|"An evaluation by the patient, administered at the last visit (or~upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the~study. Scores were measured as 0 (best) to 6 (worst)."|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
82527|NCT00979901|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
82528|NCT00979901|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
82529|NCT00979901|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily~on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal~Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The primary efficacy analysis was based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
82530|NCT00979875|Secondary|Time to Percentage of Total Insulin Exposure|Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + rHuPH20, Glulisine alone, Glulisine + recombinant human hyaluronidase PH20 (rHuPH20), Aspart alone, or Aspart + rHuPH20 with evaluable total insulin exposure data.||minutes||Standard Deviation|Mean
82531|NCT00979875|Secondary|Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)|Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.|Predose up to 120 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20) , Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-t data.||percentage of total AUC||Standard Deviation|Mean
82532|NCT00979875|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tGIR(max) data.||minutes||Standard Deviation|Mean
82533|NCT00979875|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable t(50%max) data.||minutes||Standard Deviation|Mean
82534|NCT00979875|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tmax data.||minutes||Standard Deviation|Mean
82535|NCT00979875|Primary|Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)|Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.|Predose up to 60 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-60 data.||minutes*nanomolars (min*nM)||Standard Deviation|Mean
82537|NCT00979654|Secondary|Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||ratio||Standard Deviation|Mean
82538|NCT00979654|Secondary|Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab|The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||mcg/mL||Standard Deviation|Mean
82539|NCT00979654|Secondary|Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab|The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||microgram.day per milliliter(mcg*day/mL)||Standard Deviation|Mean
82540|NCT00979654|Secondary|Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||mcg/mL||Standard Deviation|Mean
82541|NCT00979654|Secondary|Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab|The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||days||Standard Deviation|Mean
82542|NCT00979654|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab|The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||days||Full Range|Median
82543|NCT00979654|Secondary|Maximum Observed Serum Concentration (Cmax) for Sifalimumab|The Cmax is the maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
82544|NCT00979654|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration until week 182|Safety Population included all participants who received at least one dose of investigational product.||participants|||Number
82545|NCT00979628|Secondary|To Determine Differences Between Treatments Arms in # of Hypoglycemic Events||during hospitalization||||||
82546|NCT00979628|Primary|To Determine Glycemic Control Between Basal Plus(Glargine Once Daily Plus Corrective Doses of Glulisine Before Meals and Bedtime as Needed), Basal Bolus Approach of Glargine Once Daily Plus Glulisine Before Meals and SSRI||during hospitalization|||mg/dl||Standard Deviation|Mean
82547|NCT00979615|Secondary|Mean Change in Sneezing Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks|||Units on a scale||Standard Deviation|Mean
82548|NCT00979615|Secondary|Mean Change Nasal Congestion Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks|||Units on a scale||Standard Deviation|Mean
82549|NCT00979615|Secondary|Mean Change Postnasal Drip Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks|||Units on a scale||Standard Deviation|Mean
82894|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82550|NCT00979615|Secondary|Mean Change in Rhinorrhea Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week|||Units on a scale||Standard Deviation|Mean
82551|NCT00979615|Primary|Mean Change in 2-week rTNSS From Baseline|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week|||Units on a scale||Standard Deviation|Mean
82552|NCT00979576|Secondary|Cmax of Pemetrexed|Maximum measured concentration of pemetrexed in plasma (Cmax)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
82553|NCT00979576|Secondary|AUC0-inf of Pemetrexed|Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
82554|NCT00979576|Secondary|Cmax of Nintedanib|Maximum measured concentration of nintedanib in plasma (Cmax)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|PK set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
82555|NCT00979576|Secondary|AUC0-inf of Nintedanib|Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|Pharmacokinetic (PK) set||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
82556|NCT00979576|Secondary|Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in >= 20% of patients|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set||participants|||Number
82557|NCT00979576|Secondary|Duration of Disease Control|Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier.|From first study drug administration until PD or death, up to 1003 days|Patients from the treated set who achieved disease control||Days||Full Range|Median
82558|NCT00979576|Secondary|Disease Control Rate|Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set||Participants|||Number
82559|NCT00979576|Secondary|Overall Response Rate|Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set||Participants|||Number
82560|NCT00979576|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.~CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE)."|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set||participants|||Number
82561|NCT00979576|Primary|Dose Limiting Toxicities|Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course|During the first course, 21 days|Treated set||Participants|||Number
82562|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 53 + 7 days of follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
82563|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects, FPG values were missing.||mmol/L||Standard Deviation|Mean
82564|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
88699|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
82565|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
82566|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
82567|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
82568|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 22 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
82569|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
82570|NCT00978627|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
82571|NCT00979459|Secondary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event||up to 8 days|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.||participants|||Number
82572|NCT00979459|Secondary|Number of Participants Who Experienced at Least One Adverse Event||Through 30 days post-dose|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.||participants|||Number
82573|NCT00979459|Primary|Maximum Plasma Concentration (Cmax) for MK-1006|Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose|||nM||95% Confidence Interval|Geometric Mean
82574|NCT00979459|Primary|Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006|AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose|||nM*hr||95% Confidence Interval|Geometric Mean
82575|NCT00979420|Secondary|Number of Participants With Drug Related Adverse Events|Number of participants with drug related Adverse Events (AEs)|Up to 185 months|Treated set||participants|||Number
82576|NCT00979420|Secondary|Course of Absolute CD4+ Cell Count|The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years||CD4+ cells/mm3||Full Range|Median
82577|NCT00979420|Secondary|History of Therapy With Antiretroviral Medication|Participants with a history of therapy with antiretroviral medication.|Baseline|Treated set||participants|||Number
82578|NCT00979420|Secondary|Duration of Intake of Viramune|Duration of intake of Viramune|End of treatment, up to 185 months|Treated set||months||Full Range|Median
82579|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.||Participants|||Number
82580|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.||Participants|||Number
82669|NCT00978029|Secondary|Proportion of Participants Reporting Oral Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
82581|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST||Participants|||Number
82582|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT||Participants|||Number
82583|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose||Participants|||Number
82584|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.||Participants|||Number
82585|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.||Participants|||Number
82586|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.||Participants|||Number
82587|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.||CD4+ cells/mm3||Full Range|Median
82588|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.||Participants|||Number
82589|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.||log10 copies/ml||Full Range|Median
82590|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.||CD4+ cells/mm3||Full Range|Median
82591|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.||Participants|||Number
82592|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.||log10 copies/ml||Full Range|Median
82593|NCT00979212|Secondary|Response Rate||Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.||||||
82594|NCT00979212|Secondary|Ability of FDG-PET/CT Scan Data to Predict Outcome||Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.||||||
82595|NCT00979212|Secondary|Surgical Morbidities in Patients With Resectable Disease at Reassessment|A surgical morbidity is any toxicity occurring within 30 days of protocol surgery, as evaluated using CTCAE v4.0. Rates of grade 3 and higher surgical morbidity were calculated; the rates across arms were not compared.|From date of surgery to 30 days following surgery.|All eligible patients who started study treatment and received protocol surgery||percentage of patients||95% Confidence Interval|Number
82596|NCT00979212|Secondary|Acute and Late Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0||Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.||||||
82598|NCT00979212|Secondary|Overall Survival|Survival time was calculated from the date of randomization to the date of death from any cause or the date of last follow-up. The Kaplan-Meier method was used to estimate the overall survival rates. One-year survival rates were estimated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
82599|NCT00979212|Primary|Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.|The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.|From date of randomization to time of protocol surgery, approximately 12 weeks.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
82600|NCT00979199|Secondary|Cost-benefit and Cost-effectiveness Analysis|Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point.|3 months||||||
82601|NCT00979199|Primary|Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement|The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions).|3 months from enrollment|||participants|||Number
82602|NCT00979121|Other Pre-specified|Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14|CRP levels were collected on subjects at baseline and on-study. The change in concentration from baseline levels to levels on study days 6 and 14 was analyzed. Those subjects that were still alive and on study at day 6 and 14 with a measured CRP level were included in the analysis.|6 and 14 days after randomization|||mg/dL||Standard Deviation|Mean
82603|NCT00979121|Other Pre-specified|Other Secondary Out-comes|Percentage of subjects with Arrhythmia's, Bowel Ischemia, Myocardial Infarction, Ischemic Stroke, and Thromboembolism were measured.|28 days after randomization|||percentage of participants||95% Confidence Interval|Number
82604|NCT00979121|Other Pre-specified|ICU Free Days to Day 28||28 days after randomization|||days||Standard Deviation|Mean
82605|NCT00979121|Other Pre-specified|Organ Failure Free Days at Day 14|The number of days from randomization to day 14 without an organ failure. Four main organ systems were measured: cardiovascular, coagulation, hepatic function, and renal function.|14 days after randomization|||days||Standard Deviation|Mean
82606|NCT00979121|Secondary|Ventilator Free Days at Study Day 28|Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.|time of initiating unassisted breathing to day 28 after study randomization|||days||Standard Deviation|Mean
82607|NCT00979121|Primary|Hospital Mortality to Day 60.|The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.|60 days after randomization|||percentage of participants||95% Confidence Interval|Number
82608|NCT00979069|Primary|Executive Language Functions|The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, & Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct|number of correct words at pre and post separated by 12 weeks|||Mean outpoint by group at pre and post||Standard Deviation|Mean
82609|NCT00979017|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat||months||95% Confidence Interval|Median
82610|NCT00979017|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, worsening T2/FLAIR, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat||months||95% Confidence Interval|Median
82611|NCT00979017|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of treatment-related, grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat||participants|||Number
82612|NCT00979017|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage and Systemic Hemorrhage|Incidence and severity of CNS hemorrhage and systemic hemorrhage- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat||participants|||Number
82716|NCT00977561|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmin for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82613|NCT00979017|Primary|Response Rate|The percentage of participants with a complete or partial response as determined by a modification of the Response Assessment in Neuro-Oncology (RANO) criteria. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Per the criteria, confirmation of response was required. Response rate = CR+PR.|4 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
82614|NCT00978757|Primary|The Effect of Ketamine on Interleukin 6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)||Blood samples for IL-6 levels were obtained prior to surgery, upon placement of the first intravenous|||pg/ml||Standard Deviation|Mean
82615|NCT00978731|Secondary|Median Number of Months of Overall Survival (OS) (Kaplan Meier Method)|Overall survival was defined as the median number of months from baseline to death from any cause.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||months||95% Confidence Interval|Median
82616|NCT00978731|Secondary|Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||months||95% Confidence Interval|Median
82617|NCT00978731|Secondary|Number of Participants With Best Cytogenetic Response|Cytogenetic responses are based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR: 0% Ph+ cells in metaphase in bone marrow, PCyR: >0% to 35% Ph+ cells in metaphase in bone marrow, Minor CyR: >35% to 65% Ph+ cells in metaphase in bone marrow, Minimal CyR: >65% to 95% Ph+ cells in metaphase in bone marrow and No CyR: >95% to 100% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.||participants|||Number
82618|NCT00978731|Primary|Number of Participants With Dose Interruptions and Dose Reductions|Dose interruptions and reductions were allowed, in order to optimize individual participant’s hematologic, cytogenetic, and molecular response while maintaining and evaluating safety and tolerability of long-term exposure to dasatinib. A dose reduction is defined as the administration of a dose at a lower level compared to previous dose and such that reduced dose, or a lower dose, is given at least 4 consecutive times. In determining the reductions, dose level would be compared to the previous non-null dose. Dose interruption is defined as a complete omission of dosing for 4 consecutive times.|From start of study to final assessment (up to 32.2 months).|All treated participants.||participants|||Number
82619|NCT00978731|Secondary|Median Number of Months of Major Cytogenetic Response (MCyR)|MCyR: 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.The duration of MCyR was computed for chronic phase participants whose best response is either CCyR or PCyR. It was measured in months from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the date of progression or death. Participants who neither progress nor die are censored on the date of their last cytogenetic assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had MCyR (13 participants had MCyR in QD group and 9 in BID group). Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.||months||95% Confidence Interval|Median
82620|NCT00978731|Primary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded per the NCI (CTC), v3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Alanine aminotransferase (ALT): Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; Calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; Bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN; Creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC); Magnesium: Grade 3: 0.6-<0.8 or >2.46-6.6mEq/L, Grade 4: <0.6 or >6.6mEq/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
82621|NCT00978731|Secondary|Number of Participants With Major Cytogenetic Response (MCyR)|Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.||participants|||Number
82622|NCT00978731|Secondary|Median Number of Months of CHR (Kaplan Meier Method)|CHR: WBC<=ULN (range: 9.29-12.5*10^3 c\uL); ANC >=1000/mm^3;Platelets <450000/mm^3,no blasts/promyelocytes in peripheral blood; <5% myelocytes+metamyelocytes in peripheral blood; basophils in peripheral blood <20% & no extramedullary involvement. Duration computed for chronic phase participants, measured in months from first day CHR criteria met, provided they are confirmed 4 weeks later, until progression of disease, treatment discontinuation due to progressive disease or death. Participants who neither discontinue due to progression, nor progress nor die censored on date of last assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had CHR. Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.||months||95% Confidence Interval|Median
82623|NCT00978731|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR should meet all of the following criteria: WBC <= Institutional ULN; ANC >= 1000/mm^3 ; Platelets < 450 000/mm^3 , no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; basophils in peripheral blood < 20% and no extramedullary involvement (including no hepatomegaly or splenomegaly). CHR can begin only 14 days after the start of treatment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants. Data was not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.||participants|||Number
82624|NCT00978731|Primary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the National Cancer Institute(NCI)Common Toxicity Criteria (CTC), v3.0(Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L.White Blood Cells (WBC) : Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
82625|NCT00978731|Primary|Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; or possible or missing. Drug-related SAEs are those events with any relationship to the study therapy.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
82626|NCT00978731|Primary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.||participants|||Number
82627|NCT00978445|Secondary|Change in Quality of Life - Based on Quality of Life Scores PSQ-18 (Short Form Patient Satisfaction Questionnaire) Duke Anticoagulation Satisfaction Scale SF-12 (Short Form 12 Version 2) Quality of Life Questionnaire|"we are interested in the relative measure of quality of life by comparing quality of life measures through use of PSQ-18 and other measures listed.~Higher scores indicate a better quality of life."|During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3|power analysis||scores on a scale||Standard Deviation|Mean
82628|NCT00978445|Primary|Time Spent Per PT/INR Monitoring Encounter|minutes spent measuring coagulation time of blood on standard versus home protocol|Once per week during 12 week study|through minimum power study||minutes||Standard Deviation|Mean
82629|NCT00978432|Secondary|Evaluate the Association of Observed Response to the Doublet With the Response Predicted by Molecular Signatures for Activated B Cell Like (ABC) DLBCL and for Germinal Center B Cell Like (GCB) DLBCL.|"Response rates seen in subjects with activated B cell like DLBCL and for Germinal center B cell like DLBCL will be reported and assessed to see if GCB is associated with improved outcomes compared to ABC in subjects with relapsed disease who have received RAD + LBH. We will estimate the association of the ABC and GCB with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses.~The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis."|up to 13 cycles of therapy; approximately 1 year|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.|||||
82630|NCT00978432|Secondary|Distribution of Change Across Time of mTOR and HDAC-I Inhibition From Baseline Until After the 1st 2 Cycles of Study Drug in Patients Who Received LBH and RAD.|Serum markers will be measured on the first day of cycle 1 and on the first day of cycle 3. The distribution of change across time in a marker will be summarized.|after 2 cycles of study therapy; up to 8 weeks|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, serum marker analysis was not performed and no results are available.|||||
82631|NCT00978432|Secondary|Summary of Adverse Events (AEs)|Counts of adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose) experienced by patients on study drug(s). National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) is used to assess severity. Relatedness to study drug is assessed by the investigator.|From the time of first dose of study drug until 4 weeks after participant has stopped study drug; up to 1 year|Participants who consented to the study and took study drug were analyzed for this outcome measure. Total number of events per CTCAE v4 category per arm are reported if more than one event occurred.||events|||Number
82632|NCT00978432|Primary|Assessment of Association Between Observed Response to RAD001 and LBH589 and the Response Predicted by Molecular Signatures Developed in Our Pre-clinical Model|We will estimate the association of the molecular signature-predicted response to the doublet (CR+PR) with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses. Contingency tables will be used to present these associations.|From the start of combination therapy until a maximum of 2 years after completion of therapy|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.|||||
82717|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmax for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82633|NCT00978432|Primary|Overall Response Rate|Overall Response Rate is the number of participants with a partial and complete response assessed by the Updated Cheson criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. If a subject has residual lesions on CT scan and the disease was fluorodeoxyglucose (FDG) avid pre-treatment, then that subject will be considered to be in a complete response. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|after 2 cycles of each study drug or after 2 cycles of doublet, up to 24 weeks|Patients have to be on each drug for at least 2 cycles to be evaluable for response.||participants|||Number
82634|NCT00978380|Secondary|Antibody and Inhibitor Development|All subjects who received rFXIII were monitored for anti-rFXIII antibodies and inhibitor development. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors. Percentage of subjects with antibody and inhibitor development were reported.|From week 0 to week 52|The safety analysis set included all subjects exposed to trial product in this extension trial.||Percentage of subjects|||Number
82635|NCT00978380|Primary|Adverse Events (AEs)(Serious and Non-serious)|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Trial AEs (serious) included any event such as death, life-threatening experience, in-subject hospitalisation, significant disability/ congential anomaly experienced from the trial product.|All AEs were collected and reported from screening (week 0) for a minimum period of 52 weeks or until the end of trial visit.|The FAS included the 60 unique subjects exposed to trial product in this extension trial.||Events|||Number
82636|NCT00978341|Secondary|Pharmacokinetic Evaluations of Pregabalin|Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses.|Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose||||||
82637|NCT00978341|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.|FAS; Combined results for At-level and Below-level of spinal cord injury.||scores on scale||Inter-Quartile Range|Median
82638|NCT00978341|Secondary|Mechanical Pain Sensitivity Stimulus-Response Function|Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 –512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).|Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose|FAS; combined results for At-level and Below-level of spinal cord injury.||scores on scale||Standard Deviation|Mean
82639|NCT00978341|Secondary|Punctate Allodynia Area|Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]).|Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose|FAS; combined results for At-level and Below-level spinal cord injury.||cm2||Standard Deviation|Mean
82640|NCT00978341|Secondary|Dynamic Allodynia Pain Score|Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia.|Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose|FAS; Combined results for At-level and Below-level of spinal cord injury.||scores on scale||Standard Deviation|Mean
82641|NCT00978341|Secondary|Dynamic Allodynia Area|Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]).|Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,|FAS; Combined results for At-level and Below-level of spinal cord injury.||cm2||Standard Deviation|Mean
82642|NCT00978341|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)|FAS; Combined results for At-level and Below-level of spinal cord injury.||scores on scale||Standard Deviation|Mean
82771|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||swollen joints||Standard Deviation|Mean
82643|NCT00978341|Primary|Present Pain Intensity Score|Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).|Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)|Full analysis set (FAS): those subjects who completed both periods of the study. Combined results for At-level and Below-level neuropathic pain; At-level: located within 2 dermatomes above or below the level of spinal cord injury; Below-level: located at least 3 dermatomes below the level of spinal cord injury.||scores on scale||Standard Deviation|Mean
82644|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
82645|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
82646|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
82647|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroprotection: The percentage of participants with a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
82648|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
82649|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41|||percentage of participants|||Number
82650|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
82651|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28|||percentage of participants|||Number
82652|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
82653|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
82654|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay(HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
82655|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21|||percentage of participants|||Number
82656|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2|Percentage of participants with asthma exacerbations within 8 days after vaccination 2. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 21 to 28|||percentage of participants|||Number
82657|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1|Percentage of participants with asthma exacerbations within 8 days after vaccination 1. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 1 to 8|||percentage of participants|||Number
82658|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 2 by Dose Level Group.|Days 21 through 28|||percentage of participants|||Number
82659|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 1 by Dose Level Group.|Days 1 through 8|||percentage of participants|||Number
82660|NCT00978120|Primary|Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination|Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.|Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201|||percentage of participants|||Number
82661|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on MFVDS by Facial Region|The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region.|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.||percentage of responders|||Number
82662|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)|The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.||Percentage of responders|||Number
82663|NCT00978042|Secondary|Duration of Treatment Effect|Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators’ assessments (with 95% Greenwood's Confidence Interval).|24 Months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to the treatment arm who received treatment and all participants randomized to no treatment control arm who received treatment, with data available for analysis."||Percentage of participants||95% Confidence Interval|Number
82664|NCT00978042|Primary|Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)|The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.|6 months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to treatment who received treatment and all participants randomized to no treatment control arm, with data available for analysis."||percentage of responders||95% Confidence Interval|Number
82665|NCT00978029|Secondary|Proportion of Participants Who Discontinued Due to Adverse Events.|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 28|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
82666|NCT00978029|Secondary|Proportion of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
82667|NCT00978029|Secondary|Proportion of Participants Reporting Throat Irritation|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
82668|NCT00978029|Secondary|Proportion of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
88700|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
82670|NCT00978029|Primary|The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 42|All subjects as treated (ASAT) consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.||Proportion of Participants|||Number
82671|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).||percentage of patients|||Number
82672|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82673|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82674|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).||percentage of patients|||Number
82675|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82676|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82677|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).||percentage of patients|||Number
82678|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82679|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT||21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82680|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.||percentage of patients|||Number
82681|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.||percentage of patients|||Number
82682|NCT00977938|Primary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).||percentage of patients|||Number
88701|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
82683|NCT00977938|Primary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82684|NCT00977938|Primary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.||percentage of patients (KM estimate)|||Number
82685|NCT00977808|Primary|Occurrence of Hypoglycemic Episodes|Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).|Overnight (21:30 until 08:00)|Only participants who completed both study periods were considered for this assessment.||Hypoglycemic Episodes|||Number
82686|NCT00977769|Secondary|Bleeding|The calculated estimated blood loss from delivery until 2 h after intervention|120 minutes|||ml blood loss||Standard Deviation|Mean
82687|NCT00977769|Primary|Arterial Blood Pressure|The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 min|||percentage change in arterial blood pres||95% Confidence Interval|Mean
82688|NCT00977769|Primary|Cardiac Output|The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 minutes|||percentage change in cardiac output||95% Confidence Interval|Mean
82689|NCT00977704|Primary|Local and Systemic Adverse Events|"To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:~All local adverse events as reported by healthcare professional~All systemic adverse events (related and unrelated)"|2-weeks|Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data.||percentage of participants|||Number
82690|NCT00977665|Secondary|Total Number of Falls During the Study|Participants recorded each time they fell during the study in a diary.|Day 1 up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment, and who maintained diaries.||falls||Inter-Quartile Range|Median
82691|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)|The Beck Depression Inventory (BDI-II), is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Participants are asked to pick the answer for each question that best describes the way they have been feeling in the past two weeks, including the day participants complete the questionnaire. Each question is rated on a scale of 0-3, with 0 meaning the participant does not feel the emotion described in the question, and 3 meaning the participant has extremely strong feelings. Total scale is 0 (no evidence of depression) to 63 (extreme depression). Negative change from baseline scores indicate improvement in level of depression.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
82692|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling)|"UMSARS' questions are rated on a scale of 0=normal to 4=extreme impairment.~This endpoint reports the percentage of participants rated a 3 or worse. Rating 3 = Severely impaired speech (Question #1), swallowing (Question #2) or falling more frequently than once per week (Question #8)."|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||percentage of participants|||Number
82693|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale|MoCA is a cognitive screening test which helps health professionals identify mild cognitive impairment. The total scale is 0 (significant cognitive impairment) to 30 (no impairment detected). Scores >=26 are considered normal. Positive change from baseline scores indicate improvement in cognition.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
82694|NCT00977665|Secondary|Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications|"Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events:~An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study.~Dose modification of anti-parkinsonian or anti-orthostatic hypotension concomitant medications reflecting disease progression.~The event of interest, determined on a by patient basis, therefore, is the earliest event of the two events defined above. Otherwise, patient is right censored according to his/her study termination date.~Since less than 25% of participants had an event, median estimatation for time to change in medications is not possible."|Day 0 (baseline) to Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||days||95% Confidence Interval|Median
82924|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
82695|NCT00977665|Secondary|Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect|This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.|Day 0 (baseline), Week 12|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Deviation|Mean
82696|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV|UMSARS Part I is an historical review and scores symptoms of neurological and autonomic dysfunction with 12 items rated on a scale of 0 (normal) to 4 (extreme dysfunction). The full scale for Part 1 is therefore 0 (normal) to 48 (extreme dysfunction). Part II is a motor examination and has 14 items also rated on a scale of 0 to 4 for a full scale of 0 (normal) to 56 (extreme dysfunction). Part IV is a global disability scale with rates the extent of disease from 1 (normal) to 5 (severe disease).|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
82697|NCT00977665|Secondary|Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment.~The rate of progression of atrophy is represented by the slope of change from baseline scores for visits between Weeks 12 and 48."|Day 0 (baseline), Weeks 12-48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale/week||Standard Error|Mean
82698|NCT00977665|Secondary|Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale|"The Multiple System Atrophy Quality of Life questionnaire (MSA-QoL) is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 - 160, with 0= 'no problem' and 160= extreme problem."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
82699|NCT00977665|Secondary|Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit|COMPASS_Select change is comprised of 5 of the 11 domains in the COMPASS scale: Orthostatic Intolerance, Bladder Disorder, Sweating, Vasomotor, and Sleep Disorder COMPASS_Select change has a range of -150 to 150, with -150 indicating symptoms are much better and 150 indicating symptoms are much worse.|48 weeks|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
82700|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation|UMSARS' Question #7 concerns the participant's ability to walk, rated on a scale of 0=normal to 4=cannot walk at all even with assistance. This endpoint counts participants rated a 3 or worse. Rating 3 = Severely impaired; assistance and/or walking aid needed occasionally.|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||percentage of participants|||Number
82701|NCT00977665|Secondary|Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.~In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 24|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
82702|NCT00977665|Secondary|Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit|"Outcome measures the investigator's clinical impression of the participants' improvement at Week 48 as compared to Week 12. CGI scale range from 1-7, with 1=very much improved, 4= no change, and 7=very much worse.~In order to maintain the overall (hypotheses about primary and key secondary endpoints) type I error at the 0.05 level an hierarchy will be employed as follows: If the primary endpoint will be found to be significant at a significance level of 0.05 then the first key secondary endpoint will be tested, if this endpoint will be found to be significant in a significance level of 0.05 then the second key secondary endpoint will be tested and so on. The 'key' secondary endpoints are outcomes 2-6."|Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.||units on a scale||Standard Error|Least Squares Mean
82718|NCT00977561|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.|Baseline up to follow-up (90 days post dose)|All randomized participants who received at least one dose of any agent of the combination were included in the safety analysis.||participants|||Number
88702|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
82703|NCT00977665|Primary|Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)|"This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.~In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment were included in the principal efficacy analysis, according to the treatment group to which they were originally assigned.||units on a scale||Standard Error|Least Squares Mean
82704|NCT00977613|Secondary|Overall Survival||after 6 months||||||
82705|NCT00977613|Secondary|Recurrence-free Survival||after 6 months||||||
82706|NCT00977613|Secondary|Disease-free Survival||after 6 months||||||
82707|NCT00977613|Primary|Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater|One MET is the energy expenditure for sitting quietly for 1 hour. MET scores for walking were assigned based on the pace and duration reported. For other activities, a leisurely to moderate intensity score was selected. The scores for MET-hours per week for each activity were calculated from the reported hours per week engaged in that activity multiplied by the assigned MET score, and individual activities were summed to derive a total MET-hours per week.|6 months|34 of the 50 enrolled subjects had at least 6 months of follow-up. There was no evaluable data for the remaining 16 subjects.||participants|||Number
82708|NCT00977561|Secondary|Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs|Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs|Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)|No analysis of total CTCs and IGF-IR-expressing CTCs was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82709|NCT00977561|Secondary|Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers||Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)|No analysis for serum circulating IGF pathway related markers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82710|NCT00977561|Secondary|Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway||Baseline prior to dosing|No analysis of tumor biomarkers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82711|NCT00977561|Secondary|Numeric Rating Scale (NRS) Score|"The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess worst pain severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for NRS score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82712|NCT00977561|Secondary|Cancer Dyspnea Scale (CDS) Score|"The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 Not at All to 5 Very Much)."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for cancer dyspnea scale score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82713|NCT00977561|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose|No analysis of ADA response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82714|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Etoposide||Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of PK parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82715|NCT00977561|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of pharmacokinetics (PK) parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82719|NCT00977561|Secondary|Overall Survival (OS)|Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].|Every 3 months until death or 12 months from the date the last participant was randomized|No analysis of overall survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82720|NCT00977561|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of objective response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82721|NCT00977561|Primary|Progression-Free Survival (PFS)|Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of progression-free survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.|||||
82722|NCT00977548|Secondary|Leukemia Free Survival (LFS)|LFS: Survival without evidence of relapse at any time post-transplant. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||months||95% Confidence Interval|Median
82723|NCT00977548|Secondary|Median Progression Free Survival (PFS)|PFS: The time elapsed between treatment initiation and tumor progression or death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis. Disease Progression is defined using International Working Group (IWG) Response Criteria for MDS, as at least 50% decrement from maximum remission/response levels in granulocytes or platelets; reduction in hemoglobin (Hgb) concentration by ≥ 2 g/dL; transfusion dependence.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||months||95% Confidence Interval|Median
82724|NCT00977548|Secondary|Median Overall Survival (OS)|OS: The time from randomization until death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||months||95% Confidence Interval|Median
82725|NCT00977548|Primary|Combined Overall Response Rate (ORR)|Best Response Categories: Marrow complete response (CR), Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment; Hematological improvement (HI), Hgb increase by ≥ 1.5 g/dL, Absolute increase of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L, At least 100% increase and an absolute increase of > 0.5 x 10^9/L, as defined by the International Working Group (IWG) 2006 criteria.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).||participants|||Number
82726|NCT00977379|Secondary|Absolute Change From Baseline in Mini Mental State (MMS) Total Score|MMS was an 11-question measure that tested five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Four items were scored on a scale of 0 to 1; 1 item was scored on a scale of 0 to 2; 3 items were scored on a scale of 0 to 3; and 3 items were scored on a scale of 0 to 5. MMS total score was obtained by adding the scores of all individual items and ranged from 0 to 30, where higher scores indicate better cognitive state.|Baseline, Up to end of Treatment (up to 10.6 months overall)|ITT population. Here, number of participants analyzed = participants evaluable for this outcome.||units on a scale||Standard Deviation|Mean
82727|NCT00977379|Secondary|Overall Survival (OS)|OS was defined as the time from the start of study treatment to date of death due to any cause. OS was assessed using Kaplan-Meier analysis.|Baseline until death (up to approximately 1 year 5.5 months overall)|ITT population.||months||95% Confidence Interval|Median
82728|NCT00977379|Secondary|Time to Progression, Assessed by Investigator According to MRI and CT|Time to progression was defined as the time from start of study treatment to first documentation of PD or death due to tumor (CNS or extra-cranial). PD was assessed by MRI or CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS or extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS or extra-cranial lesions and/or unequivocal progression of existing CNS or extra-cranial lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||months||Full Range|Median
82729|NCT00977379|Secondary|Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT|Time to extra-cranial progression was defined as the time from start of study treatment to first documentation of PD or death due to extra-cranial lesions. PD was assessed by CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more extra-cranial lesions and/or unequivocal progression of existing extra-cranial lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||months||Full Range|Median
82730|NCT00977379|Secondary|Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT|Objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.||percentage of participants|||Number
82731|NCT00977379|Secondary|Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT)|Best objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
82732|NCT00977379|Secondary|Time to CNS Progression, Assessed by Investigator According to MRI|Time to CNS progression was defined as the time from start of study treatment to first documentation of PD or death due to CNS metastasis. PD was assessed by contrast-enhanced MRI according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||months||Full Range|Median
82733|NCT00977379|Secondary|Duration of CNS Response, Assessed by Investigator According to MRI|Duration of CNS response was defined as the time from first documented cranial CR or PR (whichever was recorded first) until the first date CNS recurrence or progression was documented as assessed by contrast-enhanced MRI according to RECIST criteria but without exam for response confirmation. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population. Here, number of participants analyzed = participants having had a CR or PR during the study.||months||Full Range|Median
82734|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.||percentage of participants|||Number
82735|NCT00977379|Secondary|Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI|Clinical benefit was defined as having CR, PR, or stable disease (SD), assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum LD since treatment started. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
82736|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI in 3 Dimension|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by 3 dimensional MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|The data for this outcome was not collected as per changes in planned analysis because sufficient information on the method used was not available.|||||
82737|NCT00977379|Secondary|Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
82738|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.||percentage of participants|||Number
88703|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
82739|NCT00977379|Primary|Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|PP population included all ITT population participants excluding participants with following major protocol violations: inclusion and exclusion criteria not met; intake of prohibited treatment, protocol design and/or visit dates not respected; and missing values for main criterion without premature withdrawal.||percentage of participants|||Number
82740|NCT00977379|Primary|Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population|Best objective CNS response was defined as having complete response (CR) or partial response (PR) for CNS metastasis, assessed by contrast-enhanced MRI using response evaluation criteria in solid tumors (RECIST). CR: disappearance of all CNS lesions. PR: greater than or equal to (>/=) 30 percent (%) decrease in sum of longest diameters (LD) of CNS lesions taking as reference the baseline sum LD.|Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.||percentage of participants|||Number
82741|NCT00977314|Secondary|Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB), a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment)|30 days|||Global Benefit Score||Standard Deviation|Mean
82742|NCT00977314|Primary|Efficacy: Ability to Understand Speech in Noise|The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.|Day 1, Day 30|||dB||Standard Deviation|Mean
82743|NCT00977314|Primary|Incidence of Device- and Procedure-related Adverse Events at 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:~Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination."|30 days|||participants|||Number
82744|NCT00977197|Secondary|Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|baseline, week 12|Intent to Treat analysis||participants|||Number
82745|NCT00977197|Secondary|Mean Bloating BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82746|NCT00977197|Secondary|Mean Diarrhea BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82747|NCT00977197|Secondary|Mean Constipation BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82770|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82748|NCT00977197|Secondary|Mean Overall Severity BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82749|NCT00977197|Secondary|Mean Pain BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82750|NCT00977197|Secondary|Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy|"One of the weekly questions asked of subjects was, Did you have adequate relief of your IBS symptoms over the last week? Possible answers were Yes or No."|Weeks 9-12|Intent to treat analysis||participants|||Number
82751|NCT00977197|Secondary|Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12)|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82752|NCT00977197|Secondary|Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82753|NCT00977197|Secondary|Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82754|NCT00977197|Secondary|Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.||units on a scale||Standard Deviation|Mean
82755|NCT00977197|Primary|Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|Intent to treat analysis||units on a scale||Standard Deviation|Mean
82756|NCT00977184|Secondary|Activities of Daily Living UPDRS|The Activities of Daily Living Unified Parkinson's Disease Rating Scale (ADL UPDRS) is a self evaluation of the activities of daily living. The following variables are rated: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed, falling, freezing when walking, walking, tremor and sensory complaints. Each variable is rated on a scale of 0 (normal) to 4 (severe impairment). A total score for the ADL UPDRS ranges from 0 (no impairment) to 52 (severe impairment).|Baseline, 1 day post rTMS|Intent to treat||units on a scale||Standard Deviation|Mean
82757|NCT00977184|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administered at baseline and at 1 day post rTMS or sham. Subjects were assessed on medication and off medication.|Baseline, 1 day post rTMS|Intent to treat.||units on a scale||Standard Deviation|Mean
82758|NCT00977184|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|Baseline, 1 day post rTMS|Intent to treat||units on a scale||Standard Deviation|Mean
88704|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
82759|NCT00977184|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|Baseline, 1 day post rTMS|||seconds||Standard Deviation|Mean
82760|NCT00977184|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real rTMS and sham rTMS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline and 1 day post intervention.|Baseline, 1 day post rTMS|Intent to treat||seconds||Standard Deviation|Mean
82761|NCT00977171|Primary|Patient Global Impression of Improvement|The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.|Baseline to end of 12 week treatment period|3 patients enrolled in the study prior to it being stopped due to difficulty enrolling patients.||units on a scale||Standard Deviation|Mean
82762|NCT00977106|Secondary|DAS40 During the Open Treatment Period|DAS40 was calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate, and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS40 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
82763|NCT00977106|Secondary|Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period|DAS40 calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
82764|NCT00977106|Secondary|DAS28 During the Open Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
82765|NCT00977106|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
82766|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) for a total possible score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
82767|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82768|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||swollen joints||Standard Deviation|Mean
82769|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints) . Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
85188|NCT00952822|Secondary|Infusion Site Pain|Pain was assessed by participants (≥5 years of age) on a visual analog scale (VAS) from 0 (no pain) to 100 (worst possible pain).|Within 5 minutes post-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion||Scores on a scale||Full Range|Median
82772|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
82773|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.|Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82774|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||tender joints||Standard Deviation|Mean
82775|NCT00977106|Secondary|TJC Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for tenderness and joints were classified as tender (1)/not tender (0), giving a total possible tender joint count score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
82776|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82777|NCT00977106|Secondary|Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||tender joints||Standard Deviation|Mean
82778|NCT00977106|Secondary|Hemoglobin Concentration During the Open Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as g/dL.|Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
82779|NCT00977106|Secondary|Hemoglobin Concentration During the Double-Blind Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as grams per deciliter (g/dL).|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
82780|NCT00977106|Secondary|FACIT-F During the Open Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
82781|NCT00977106|Secondary|Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Week 1 and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
82794|NCT00977106|Secondary|Serum Amyloid A Component During the Open Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation measured in mg/L. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
82925|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||picomole per liter (pmol/L)||Standard Deviation|Mean
82782|NCT00977106|Secondary|Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Day 0, Week 1, and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
82783|NCT00977106|Secondary|HAQ-DI During the Open Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
82784|NCT00977106|Secondary|HAQ-DI During the Double-Blind Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Screening and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
82785|NCT00977106|Secondary|Weekly Methotrexate (MTX) Dose|Before entering the study, participants had to be treated with MTX for at least 12 weeks and at a stable dose for at least 8 weeks before the screening visit (10-25 mg per week [mg/week] of oral or parenteral MTX). During the study, treatment with MTX had to be stable during the first month and then could be continued or modified, at the investigator’s discretion.|Baseline and Weeks 24 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mg/week||Standard Deviation|Mean
82786|NCT00977106|Secondary|Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period|S-OGP is a biological marker of bone and cartilage metabolism measured as picomoles per liter (pmol/L). Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||pmol/L||Standard Deviation|Mean
82787|NCT00977106|Secondary|Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period|S-PIIINP, S-CTX-I, and S-PINP are biological markers of bone and cartilage metabolism. Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||ng/mL||Standard Deviation|Mean
82788|NCT00977106|Secondary|S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period|S-Sclerostin and P-Dkk1 are biological markers of bone and cartilage metabolism measured as picograms/milliliter (pg/mL). Baseline is the closest value plus or minus (+/-) 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline, Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||pg/mL||Standard Deviation|Mean
82789|NCT00977106|Secondary|Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period||Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
82790|NCT00977106|Secondary|Bone Mineral Density|To describe bone mineral density (BMD), standardized values were calculated for lumbar spine, hip, femoral neck, and trochanter, taking into account the type of Dual energy X ray absorptiometry (DXA) used. All DXA at baseline were taken into account (done from before screening to Week 8). DXA at end of study were taken into account if they were done after at least 6 infusions of tocilizumab. Values were measured in milligrams per square centimeter (mg/cm^2).|Baseline and Week 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mg/cm^2||Standard Deviation|Mean
82791|NCT00977106|Secondary|Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation. If baseline value was equal to 0, it was replaced by 0.1 to calculate the change from baseline.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82792|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mg/L||Standard Deviation|Mean
82793|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Open Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population;n=number of participants assessed for the specified parameter at a given visit.||mcg/mL||Standard Deviation|Mean
82795|NCT00977106|Secondary|Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation. A negative change from baseline indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82796|NCT00977106|Secondary|Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L. A reduction in SAA indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mg/L||Standard Deviation|Mean
82797|NCT00977106|Secondary|C- Reactive Protein During the Open Treatment Period|C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||ng/L||Standard Deviation|Mean
82798|NCT00977106|Secondary|Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation. Negative changes from baseline indicate improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82799|NCT00977106|Secondary|C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). A reduction in CRP indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||ng/mL||Standard Deviation|Mean
82800|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Open Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm/hr. A reduction in ESR indicates improvement. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
82801|NCT00977106|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment|Erythrocyte sedimentation rate is a biological marker of inflammation. A negative change indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82802|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr). A reduction in ESR indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm/hr||Standard Deviation|Mean
82803|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage change from baseline.|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82804|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage (%) change from baseline.|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||percent change||Standard Deviation|Mean
82805|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Negative change from baseline indicated improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
82806|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 metacarpal phalangeal [MCP; left and right] joints, 5 proximal interphalangeal [PIP; left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 metatarsal phalangeal [MTP; left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120. A score of 0 indicated no damage and a score of 120 indicated most severe damage. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. A negative change from baseline indicated improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||units on a scale||Standard Deviation|Mean
82807|NCT00977106|Secondary|Patient Global Assessment of Pain During the Open Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed at a specific visit||mm||Standard Deviation|Mean
82808|NCT00977106|Secondary|Patient Global Assessment of Pain During the Double-Blind Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
82809|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Open Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
82810|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
82811|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Open Treatment Period|Participants were asked to rate their assessment of disease activity using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36 and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
82812|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period|Participants were asked to rate their assessment of disease activity using a visual analog scale (VAS) of 0 to 100 millimeters (mm), where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 1 and 4|ITT Population; number (n) = number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.||mm||Standard Deviation|Mean
82813|NCT00977106|Primary|Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.|Week 4|ITT Population||percentage of participants|||Number
82814|NCT00977080|Secondary|Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was > 10.5 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)||Participants|||Number
82815|NCT00977080|Secondary|Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was < 8.4 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)||Participants|||Number
82816|NCT00977080|Secondary|Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
82817|NCT00977080|Secondary|Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
82818|NCT00977080|Secondary|Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
82819|NCT00977080|Primary|The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)||Participants|||Number
82820|NCT00976989|Secondary|Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures|Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.|From baseline up to approximately 3.5 years|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable.||percentage (ejection fraction)||Standard Deviation|Mean
82821|NCT00976989|Secondary|Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events|Percentage of participants with LVEF events without signs or symptoms of cardiac events.|From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.||percentage of participants|||Number
82822|NCT00976989|Secondary|Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)|Percentage of participants with signs or symptoms of cardiac events.|From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.||percentage of participants|||Number
82823|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event|Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.||percentage of participants|||Number
82824|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event|The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.||percentage of participants|||Number
82825|NCT00976989|Secondary|Efficacy: Percentage of Participants Without an Overall Survival (OS) Event|Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.||percentage of participants|||Number
82826|NCT00976989|Secondary|Efficacy: Percentage of Participants Achieving Breast Conserving Surgery|This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.|At approximately 18 weeks|Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.||percentage of participants|||Number
88705|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
82827|NCT00976989|Secondary|Efficacy: Time to Clinical Response|Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|Up to 18 weeks|ITT population included all participants who were randomized to treatment.||weeks||95% Confidence Interval|Median
82828|NCT00976989|Secondary|Efficacy: Clinical Response Rate|Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|During each 3-week cycle of 6 total cycles: up to 18 weeks|ITT population included all participants who were randomized to treatment.||percentage of participants|||Number
82829|NCT00976989|Secondary|Efficacy: Percentage of Participants With Complete Pathological Response (pCR)|pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.|At surgery, after 18 weeks (6 cycles) of treatment|Intent to treat (ITT) population included all participants who were randomized to treatment.||percentage of participants||95% Confidence Interval|Number
82830|NCT00976989|Primary|Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period|Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of <50% during the pre-operative (neoadjuvant) period.|From baseline up to approximately 18 weeks|Safety population included all participants who were randomized and received study drug.||percentage of participants|||Number
82831|NCT00976989|Primary|Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator|Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.|From baseline up to approximately 3.5 years|Safety population included all participants who were randomized and received study drug.||percentage of participants|||Number
82832|NCT00976950|Secondary|Change in CD4+ Cell Count From Baseline at Week 48||48 weeks|Treated set with with non-missing data at the visit||cells/mm^3||Standard Deviation|Mean
82833|NCT00976950|Secondary|Virologic Response|Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.|48 weeks|Treated set (TS), defined as patients treated with Aptivus||Number of participants|||Number
82834|NCT00976950|Primary|Number of Patients Reporting Adverse Events (AE)|Any type of adverse events|48 weeks|Treated set (TS), defined as patients treated with Aptivus||Participants|||Number
82835|NCT00976937|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
82836|NCT00976937|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||ratio||Standard Error|Least Squares Mean
82837|NCT00976937|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
82838|NCT00976937|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
82839|NCT00976937|Other Pre-specified|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
82840|NCT00976937|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
82841|NCT00976937|Secondary|Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment–Beta (HOMA-beta) at Week 24|HOMA-beta was derived from FPG and FPI as: (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||percentage of normal beta cells function||Standard Error|Least Squares Mean
82842|NCT00976937|Secondary|Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24|HOMA-IR was derived from FPG and FPI as: (FPI [micro units per milliliter]*FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-IR by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-IR assessment during on-treatment period.||mU * mmol/L^2||Standard Error|Least Squares Mean
82843|NCT00976937|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
82844|NCT00976937|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|Change was calculated for fasting glucagon and 2-hour postprandial glucagon by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||ng/L||Standard Error|Least Squares Mean
82845|NCT00976937|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||nmol/L||Standard Error|Least Squares Mean
82846|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
82847|NCT00976937|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
82848|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
82849|NCT00976937|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
82850|NCT00976937|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
82851|NCT00976937|Secondary|Absolute Change From Baseline in HbA1c at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
82852|NCT00976937|Primary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24|Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population included randomized patients who received at least 1 dose of study drug. Missing data was imputed using Last observation carried forward (LOCF).||percentage of participants|||Number
82853|NCT00976911|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)|The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.|Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)|ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit.||percentage of participants||95% Confidence Interval|Number
82854|NCT00976911|Secondary|Overall Survival (Data Cutoff 25 January 2013)|Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
82855|NCT00976911|Primary|Progression Free Survival (PFS; Data Cutoff 14 November 2011)|PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with an event of progression or death were included in the analysis||months||95% Confidence Interval|Median
82856|NCT00976911|Secondary|Percentage of Participants Who Died (Data Cutoff 25 January 2013)||Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population||percentage of participants|||Number
82857|NCT00976911|Secondary|Duration of Objective Response (Data Cutoff 14 November 2011)|For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan−Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with a best overall confirmed response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
82891|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mmol Cr||Standard Deviation|Mean
88706|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
82858|NCT00976911|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
82859|NCT00976911|Primary|Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)|Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population: All participants randomized to study treatment, irrespective of whether or not the assigned treatment was actually received. For all efficacy analyses, participants were grouped according to the treatment assigned at randomization||percentage of participants|||Number
82860|NCT00976716|Secondary|Summary of Adverse Events|The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|8 days|The safety analysis set consisted of all patients who had taken at least one study medication.||Participants|||Number
82861|NCT00976716|Secondary|Withdrawal Due to Lack of Efficacy|The number of subjects who withdrew due to insufficient clinical response was evaluated.|8 days|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.||Participants|||Number
82862|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose|The investigator assessed the localized warmth, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||Participants|||Number
82863|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose|The investigator assessed the redness, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||Participants|||Number
82864|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose|The investigator assessed the swelling, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||Participants|||Number
82865|NCT00976716|Secondary|Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.|Two, 4 and 6 hours post first dose|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.||mm||95% Confidence Interval|Mean
82866|NCT00976716|Secondary|Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose|6 hours|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID.||mm||95% Confidence Interval|Mean
82867|NCT00976716|Secondary|PID in Pain on Active Movement Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
82892|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
82868|NCT00976716|Secondary|Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
82869|NCT00976716|Secondary|PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose|The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
82870|NCT00976716|Secondary|Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose|The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.||mm||Standard Deviation|Mean
82871|NCT00976716|Secondary|Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated “Excellent” and “Good”)|"The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”~Efficacy was based on the patient impression of the study medication (excellent and good) from the first study medication until each time point."|6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.||Participants|||Number
82872|NCT00976716|Primary|Patient Impressions at Final Visit (the Number of Participants Who Have Rated “Excellent” and “Good”)|"The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”~Efficacy was based on the patient impression of the study medication (“excellent” and “good”) from the first study medication until Final Visit."|8 days|The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.||Participants|||Number
82873|NCT00976703|Other Pre-specified|Maternal Morbidities|post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT|30 days after delivery|||diagnoses|||Number
82874|NCT00976703|Secondary|Time to Foley Expulsion|time from Foley placement until it is spontaneously expulsed from the cervix|an average of 2 hours, up to 12 hours|||hours||Full Range|Median
82875|NCT00976703|Secondary|Patient Pain/Comfort Rating|Using a visual analog pain scale, with 0 being no pain and 10 being the most severe pain possible, the patients were asked to assess their pain every hour. The highest pain score recorded while the Foley catheter was in place was used. The data are reported as the median and range.|an average of 20 hours, up to 40 hours|All patients had pain scores recorded and used in analysis. The values in the table represented the recorded data available and used in the analysis.||units on a scale||Full Range|Median
82876|NCT00976703|Primary|Time to Delivery||an average of 20 hours, up to 40 hours|In order to find a 20% difference with a 40% standard deviation, power of 90%, and alpha of 0.05, we estimated we needed 86 patients in each arm. We aimed to recruit 194 patients to account for potential dropouts and missing data.||hours||Standard Deviation|Mean
82877|NCT00976677|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years|All eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
82878|NCT00976664|Primary|Oswestry Disability Index (ODI)|This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.||units on a scale||Standard Deviation|Mean
82879|NCT00976664|Primary|Visual Analog Scale (VAS)|This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.||units on a scale||Standard Deviation|Mean
82893|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as nanogram per millimoles of creatinine (ng/mmol Cr).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
82880|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
82881|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
82882|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
82883|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
82884|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
82885|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||units on a scale||Standard Deviation|Mean
82886|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in TJC; >= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
82887|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in TJC; >= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
82888|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||percentage of participants|||Number
82889|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
82890|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mmol Cr||Standard Deviation|Mean
82895|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82896|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||pg/mL||Standard Deviation|Mean
82897|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||pg/mL||Standard Deviation|Mean
82898|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82899|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82900|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82901|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82902|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82903|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82904|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
82905|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82906|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||ng/mL||Standard Deviation|Mean
82907|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82926|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82908|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82909|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
82910|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82911|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82912|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82913|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1|Serum samples were analyzed for SAA concentrations using meso scale discovery (MSD) single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific Electro ChemiLuminescent ImmunoAssay (ECLIA).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.||ng/mL||Standard Deviation|Mean
82914|NCT00976599|Primary|Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of IL-34 and IL-18 were not performed as a valid assay was not available.|||||
82915|NCT00976599|Primary|Plasma Level of Matrix Metallopeptidase (MMP13)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of MMP13 was not performed as valid assay for MMP13 was not available.|||||
82916|NCT00976599|Primary|Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
82917|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
82918|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
82919|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
82920|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
82921|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pmol/L||Standard Deviation|Mean
82922|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 10|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pmol/L||Standard Deviation|Mean
82923|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||picomole per liter (pmol/L)||Standard Deviation|Mean
82927|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82928|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82929|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82930|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82931|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82932|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 10|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82933|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82934|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82935|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82936|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
82937|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82938|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82939|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
82940|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
83430|NCT00972543|Secondary|Haematology Laboratory Assessments - Monocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
82941|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
82942|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
82943|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
82944|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||ng/mL||Standard Deviation|Mean
82945|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific Enzyme-Linked Immunosorbent Assay [ELISA] method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
82946|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82947|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82948|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82949|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82950|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82951|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82952|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82953|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
83431|NCT00972543|Secondary|Haematology Laboratory Assessments - Lymphocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
82954|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
82955|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1|Blood samples were collected for fluorescence-activated cell sorting [FACS] analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, Bone-marrow cells (B cells) and natural killer (NK) cells were analyzed using fluorescent-labeled antibodies against clusters of differentiation (CD) markers.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells per microliter (cells/mcL)||Standard Deviation|Mean
82956|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 35 or Early Termination|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82957|NCT00976599|Primary|Blood Cytokine Level at 24 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82958|NCT00976599|Primary|Blood Cytokine Level at 8 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82959|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82960|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82961|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82962|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 10|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82963|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 hours post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||pg/mL||Standard Deviation|Mean
82964|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 hour post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
83048|NCT00975507|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.||Participants|||Number
82965|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, active 70 kDa (p70) form of IL-12(IL-12p70), interferon gamma (IFNgamma) - induced protein 10 (IP-10), TNFalpha, granulocyte macrophage colony-stimulating factor (GM-CSF), macrophage inflammatory protein 1 alpha (MIP1a), monocyte chemotactic protein 1 (MCP1), soluble vascular endothelial growth factor (sVEGF), soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), granulocyte colony-stimulating factor (G-CSF) was measured by immunoassay and the levels were expresses as picogram per milliliter (pg/mL).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.||pg/mL||Standard Deviation|Mean
82966|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3E, STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||REU||Standard Deviation|Mean
82967|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3 epsilon (CD3E), STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Baseline (Day -7)|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||REU||Standard Deviation|Mean
82968|NCT00976599|Primary|Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28|The intensity of CD3 and CD68 cell infiltration was expressed as the percentage area of the tissue section occupied by positively stained cells. Surface marker CD68 macrophages and CD3 thymus cells (T cells) in the inflammatory cells of synovial tissue were detected by immunohistochemical staining.|Baseline (Day -7), Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage area stained||Standard Deviation|Mean
82969|NCT00976599|Primary|Change From Baseline in Protein Expression of Tumor Necrosis Factor Alpha (TNFalpha), Interleukin-6 (IL-6), Interleukin-17a (IL-17a) and Interleukin-10 (IL-10) at Day 28|Synovial tissue biopsy was to be performed and assayed for protein expression by quantitative PCR using standard curve method. Standard curve was to be generated by linear regression using log threshold cycle versus log (cell number). TNFalpha, IL-6, IL-17 and IL-10 data were to be presented as control normalized expression (relative expression) within synovial tissue.|Baseline (Day -7), Day 28|Analyses of TNFalpha, IL-6, IL-17 and IL-10 were not performed due to insufficient samples and lack of appropriate method to process/analyze the samples.|||||
82970|NCT00976599|Primary|Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28|Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.|Day -7 (Baseline), Day 28|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study medication. Analyses of tumor necrosis factor alpha(TNFα), receptor activator of nuclear factor kappa-B ligand(RANKL), osteoprotegerin(OPG) were not performed due to insufficient samples and lack of appropriate method to process/analyze samples.||relative expression unit (REU)||Standard Deviation|Mean
82971|NCT00976521|Secondary|Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration|The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.|30 Days|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total myocardial mass were available for 192 and 190 patients randomized to thrombus aspiration versus no no thrombus aspiration, respectively for the ITT (intention to treat) analysis set.||Percentage of Total Myocardial Mass||Inter-Quartile Range|Median
82972|NCT00976521|Primary|Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion|The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.|30 Days Post Index Procedure|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total left ventricular mass were available for 181 and 172 patients randomized to intracoronary abciximab infusion versus no abciximab infusion, respectively for the ITT (intention to treat) analysis set.||Percentage of Left Ventricular Mass||Inter-Quartile Range|Median
83086|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
82973|NCT00976508|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)|Response-evaluable set: All participants who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment.||participants|||Number
82974|NCT00976508|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing ADA for figitumumab.|Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82975|NCT00976508|Secondary|Mean Change in Glucose Levels Between Fasting and Post Glucose Load|The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.|Screening; Day 8 of Cycle 1; Day 15 of Cycle 2|Glucose tolerance set: All enrolled participants who started treatment and who had at least one baseline or on-study sample submitted. N=number of participants with analyable data for this outcome measure.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
82976|NCT00976508|Secondary|Area Under the Trough Concentrations (AUCtrough)|The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.|Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82977|NCT00976508|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82978|NCT00976508|Secondary|Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.|Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82979|NCT00976508|Secondary|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82980|NCT00976508|Secondary|Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82981|NCT00976508|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82982|NCT00976508|Secondary|Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.|||||
82983|NCT00976508|Secondary|Serum Circulating Insulin-like Growth Factor (IGF-1) Levels|The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.|Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|Biomarker analysis set: all enrolled participants who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
82984|NCT00976508|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.|From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. N=number of participants remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications.||participants|||Number
82985|NCT00976508|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From Screening to the follow-up visit (90 days after last dose of figitimumab)|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications.||Participants|||Number
82986|NCT00976482|Primary|Two-year All-cause Mortality||2 years|||percentage of participants||95% Confidence Interval|Number
82987|NCT00976456|Secondary|Overall Survival|Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).|42 months|||months||95% Confidence Interval|Median
82988|NCT00976456|Primary|Progression Free Survival|Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).|42 months|||months||95% Confidence Interval|Median
82989|NCT00976404|Secondary|Serious Adverse Events Attributed to Study Treatments|Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine)|56 weeks|||serious adverse events|||Number
82990|NCT00976404|Secondary|HIV Specific T-cell Response to Env|HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting)|36 weeks|||response per 10^6 PBMCs||Standard Deviation|Median
82991|NCT00976404|Secondary|Change From Baseline in CD4+ T Cell Count at Week 56||Week 56|||cells per mm^3||Inter-Quartile Range|Median
82992|NCT00976404|Secondary|Change From Baseline in HIV DNA in Rectal Tissue at Week 56||Week 56|||log^10 copies per 10^6 cells||Inter-Quartile Range|Median
82993|NCT00976404|Primary|Change From Baseline in HIV DNA in PBMCs at Week 56||56 weeks|||log^10 copies per 10^6 PBMCs||Inter-Quartile Range|Median
82994|NCT00976391|Secondary|Change From Baseline in Body Weight at Weeks 36, 48 and 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed (represented by n=X, X in the category title).||Kilograms||Standard Deviation|Mean
82995|NCT00976391|Secondary|Change From Baseline in Body Weight at Week 26|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy.|Baseline and Week 26|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.||Kilograms||Standard Error|Least Squares Mean
82996|NCT00976391|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 4 and <Week 8; HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 8 and <Week 12; HbA1c >8.5% and >=4 weeks since uptitration between >=Week 12 and <Week 16; HbA1c >8.0% and >=4 weeks since uptitration; HbA1c >7.5% and >=4 weeks between >Week 26 and >=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 52)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
82997|NCT00976391|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7.0% at Week 26) were assessed.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.||Participants|||Number
82998|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category title).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
82999|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
83000|NCT00976391|Secondary|Change From Baseline in HbA1c at Weeks 36, 48 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
83001|NCT00976391|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 26.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
83002|NCT00976339|Primary|Number of Participants That Successfully Completed the 1-year Intervention||1 year|Regarding secondary objective, samples were collected; however, no viable data or outcomes are available from the collection.||participants|||Number
83003|NCT00976274|Secondary|Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)||baseline and 12 weeks|||uIU/mL||Standard Deviation|Mean
83004|NCT00976274|Primary|Change in the Pre- and Post-treatment Systolic Blood Pressure||baseline and 12 weeks|||mm Hg||Standard Deviation|Mean
83005|NCT00976248|Primary|Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM||End of follow-up|13 participants were censored due to follow-up ending prior to new therapy initiation.||Months||Full Range|Median
83006|NCT00976248|Primary|Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM.||End of Treatment|13 participants were excluded from this analysis due to treatment and follow-up ending prior to progression.||Months||Full Range|Median
83007|NCT00976248|Primary|Overall Response Rate of RAD001 in Patients With Previously Untreated WM|"Overall Response = Complete Response + Near Complete Response + Very Good Partial Response + Partial Response + Minor Response Complete Response: resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A near CR (nCR) is defined as fulfilling all CR criteria in the presence of positive immunofixation test for an IgM paraprotein.~Very Good Partial Response: > 90% reduction in serum IgM levels. Partial Response: > 50% reduction in serum IgM levels. Minor Response: 25-49% reduction in serum IgM levels Progressive Disease: greater than 25% increase in serum IgM level occurs from the lowest attained response value or progression of clinically significant disease related symptom(s).~Stable Disease: < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM"|End of Treatment|||participants|||Number
83008|NCT00976209|Secondary|Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets|"Convenience was calculated based on total participants that completed the study.~Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:~Secondary Endpoint~Which product, if any, was more convenient?~The possible answers were:~I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)~I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)~or~• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.||Percentage of participants|||Number
83009|NCT00976209|Primary|Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion|"Preference was calculated based on total participants that completed the study.~Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:~Which product, if any, did you prefer for the relief of nasal congestion?~The possible answers were:~I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)~I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)~or~• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.||Percentage of participants|||Number
83010|NCT00976027|Other Pre-specified|Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone|Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis|Day 0 before vaccination to Day 180 after vaccination|Adverse events of special interest were assessed in all participants who received study vaccine (Full Analysis Set).||Participants|||Number
83394|NCT00972816|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.~Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10)."|Day 1, Day 22, Day 29, Day 43|||Titers||95% Confidence Interval|Geometric Mean
83011|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)|Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 14 (post-vaccination) up to 12 Months post-vaccination|The occurrence of events associated with CDC defined ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).||Participants|||Number
83012|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)|Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 0 (pre-vaccination) up to the end of the influenza season|The occurrence of events associated with ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).||Participants|||Number
83013|NCT00976027|Primary|Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.|The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.|Day 0 (pre-vaccination) up to Year 1 post-vaccination|Efficacy was assessed in all participants who met all study inclusion criteria and none of the exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per Protocol Analysis Set).||Participants|||Number
83014|NCT00975975|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.||days||95% Confidence Interval|Median
83015|NCT00975975|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.||days||95% Confidence Interval|Median
83016|NCT00975975|Primary|Grade 3-4 Acute GVHD Rate|The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment||percentage of participants||95% Confidence Interval|Number
83017|NCT00975923|Secondary|Access of Tools and Use of Quality Improvement Strategies|Follow-up survey of ICU nurse and quality managers for all participating medical centers from Jan 2008 through April 2008 included questions about the implementation of process interventions: Access and use of clinical guidelines tools, access and use of quality improvement tools, and types of quality improvement implementation strategies.|18 months|per protocol||Percentage of ICUs|||Number
83018|NCT00975923|Primary|CLABSI and VAP Rates|Central line associated bloodstream infections(CLABSI) and ventilator associated pneumonias (VAP) using Centers for Disease Control and Prevention definitions as number of events per 1,000 device days, data collection and surveillance methods.|18 Months: 3-month baseline and quarterly post-intervention periods|A cluster randomized trial randomly assigned hospitals to either the Collaborative or Tool Kit groups, stratified by region within the United States and ICU volume. Implementation and analysis was at the level of the ICU. One of the 30 hospital in the Tool Kit Group was sold, leaving 29 hospitals. Analysis was conducted per protocol.||events/1000 device days||Inter-Quartile Range|Median
83019|NCT00975806|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the start of study drug therapy to death.|Day 1 of study drug to death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
83020|NCT00975806|Secondary|Duration of Response|Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)|Day 1 of initial response date to progressive disease|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
83021|NCT00975806|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.|Day 1 of study drug to disease progression or death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including MTD, were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
83422|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83022|NCT00975806|Secondary|Phase 1 : Tumor Response Rate According to RECIST 1.1|"Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria:~Treatment response includes both complete response and partial response~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir"|Every 3 cycles; up to month 25|Intent to Treat Population includes participants who took at least one dose of study drug. Study participants with stable disease also reported.||participants|||Number
83023|NCT00975806|Secondary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death|First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively|Safety population includes all participants who received at least one dose of study drug.||participants|||Number
83024|NCT00975806|Primary|Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|"Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions.~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir."|After at least 3 cycles of treatment|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.|||||
83025|NCT00975806|Primary|Phase 1: Maximum Tolerated Dose (MTD)|"The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were:~• Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:~Grade (GR) 3 or 4 non-hematological toxicity lasting for ≥ 14 days~Febrile neutropenia~Gr 4 neutropenia lasting for ≥ 7 days~Gr 4 thrombocytopenia The occurrence of one of the above drug-related toxicities resulting in a clinical and/or laboratory assessment being done within 7 days following the initial finding to examine the participants for resolution of the toxicity. Lack of resolution of the toxicities was considered a DLT.~If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation."|Within 21 days of first dose of treatment|Safety population includes all participants who received at least one dose of the study drug.||mg|||Number
83026|NCT00975780|Secondary|Lower Respiratory Tract Infection Other Than Pneumonia|The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.|2.5 years|||participants|||Number
83027|NCT00975780|Primary|Pneumonia|The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.|2.5 years|||participants|||Number
83028|NCT00975715|Secondary|Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group|Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).|56 days|The Analysis set included all participants who received study drug and had data available for analysis.||participants|||Number
83029|NCT00975715|Secondary|Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type|Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.|28 days|Analyzed set includes all participants who received study drug and had both baseline and post baseline data available.||percentage change in seizure frequency||Standard Deviation|Mean
83030|NCT00975715|Secondary|Percent of Participants With Response During Double-blind Phase, by Treatment Group|Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.|screening to 28 days|The Full Analysis set included all participants who received study drug.||percentage of participants|||Number
83031|NCT00975715|Secondary|Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group|Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)” = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28.|baseline, 28 days and 56 days|The Full Analysis set included all participants who received study drug.||seizures per 28 days||Standard Deviation|Mean
83087|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
83032|NCT00975715|Primary|Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group|Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: “Percent change in partial onset seizure frequency per 28 days from the screening phase” = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 “Partial onset seizure frequency per 28 days” = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.|screening and 28 days|The Full Analysis set included all participants who received study drug.||percentage change per 28 days||Standard Deviation|Mean
83033|NCT00975689|Primary|Oxysterol Levels||Six months|Every patient in the trial received the study drug as well as the placebo.||ng/mL||Standard Error|Mean
83034|NCT00975637|Secondary|To Evaluate the Efficacy of AMG 827 as Measured by the Following: Body Surface Area (BSA) Involvement at Weeks 12||12 weeks|||percentage of BSA psoriasis||Standard Deviation|Mean
83035|NCT00975637|Primary|To Establish a Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 and to Identify an Appropriate Dose Regimen for Future Trials||12 weeks|||percentage of psoriasis improvement||Standard Deviation|Mean
83036|NCT00975611|Primary|Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.||week 4 and week 8|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.|||||
83037|NCT00975585|Secondary|Symptoms of Dryness|Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
83038|NCT00975585|Secondary|Bulbar Redness|The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
83039|NCT00975585|Secondary|Limbal Redness|The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
83040|NCT00975585|Primary|Overall Comfort|After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks and 4 weeks|Analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
83041|NCT00975585|Primary|Overall Comfort|After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks|Analysis includes subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
83042|NCT00975585|Primary|Visual Acuity|Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|2 weeks|||logMAR units||Standard Error|Least Squares Mean
83043|NCT00975585|Primary|Average Corneal Staining|The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.|2 weeks|Analysis included all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
83044|NCT00975507|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
83045|NCT00975507|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
83046|NCT00975507|Secondary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.||Participants|||Number
83047|NCT00975507|Secondary|Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
83088|NCT00975195|Secondary|Change in On-treatment PEFR as Measured by Home Based Spirometry|Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set||Litres/sec||Standard Error|Least Squares Mean
83049|NCT00975481|Primary|Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)|ARCI (BG) is measure of other subjective effects. It is a set of 13 questions in which each question contributes to total score. Participants select ‘False’ / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects. Emax: largest effect score between 0 - 24 hours post-dose. Emin: smallest effect score between 0 - 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on Scale||Standard Deviation|Mean
83050|NCT00975481|Primary|Other Subjective Effects- Drug Similarity|Drug similarity VAS is one of the measures of other subjective effects. It assesses the similarity of the drug recently received by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= not at all similar) to 'extremely' (score of 100 mm= very similar). Recently received drugs were compared with placebo, benzodiazepines, codeine/morphine, Tetrahydrocannabinol (THC), pseudoephedrine.|12 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period. 'n' is signifying those participants who were evaluated for this measure for various drugs for similarity in each treatment group.||mm||Standard Deviation|Mean
83051|NCT00975481|Primary|Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])|Any drug effects VAS is one of the measures of other subjective effects. It assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is the largest effect score between 0.5 to 24 hours post-dose.|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83052|NCT00975481|Primary|Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)|"Alertness/Drowsiness VAS is one of the measures of sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither drowsy nor alert (score of 50 mm), on the left with very drowsy (score of 0 mm) and on the right with very alert (score of 100 mm). Emin is the smallest effect score between 0 to 24 hours post-dose."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83053|NCT00975481|Primary|Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)|ARCI (PCAG) is one of the measures of sedative effects. It is a set of 15 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when answer is opposite to scoring direction. Score range: 0 to 15, higher score indicated higher sedative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on Scale||Standard Deviation|Mean
83054|NCT00975481|Primary|Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)|ARCI (LSD) is one of the measures of negative effects. It is a set of 14 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to scoring direction. Score range: 0 to 14, higher score indicated higher negative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on Scale||Standard Deviation|Mean
83055|NCT00975481|Primary|Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])|"Bad effects VAS is one of the measures of negative effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is largest effect score between 0.5 to 24 hrs."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83056|NCT00975481|Primary|Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])|"High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is largest effect score between 0 to 24 hours."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83089|NCT00975195|Secondary|Change in On-treatment FVC as Measured by Home Based Spirometry|Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set||Litres||Standard Error|Least Squares Mean
83057|NCT00975481|Primary|Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])|"Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is the largest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83058|NCT00975481|Primary|Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)|ARCI (MBG) is one of the measures of positive effects. It is a set of 16 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to the scoring direction. Score range: 0 to 16, higher score indicated positive effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Units on scale||Standard Deviation|Mean
83059|NCT00975481|Primary|Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)|SDV is one of measures of balance of effects. It is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between drug administered and different monetary values. Participants were asked to choose between receiving another dose of same drug or an envelope containing specified amount of money, but they did not receive drug or money as described. Possible score range from 0.25 to 50. Higher score range indicates higher SDV. Emax: largest effect score between 6-24 hours post-dose.|6, 12, 24 hrs post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||Dollar||Standard Deviation|Mean
83060|NCT00975481|Primary|Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Good and Bad effects VAS is one of the measures of balance of effects that assesses the effect experienced by the participant on a 100 mm bipolar VAS, anchored in the center with a neutral anchor of neither good nor bad effects (score of 50 mm), on the left with bad effects(score of 0 mm) and on the right with good effects (score of 100 mm).~Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83061|NCT00975481|Primary|Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])|"Take drug again VAS is one of the measures of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely not, 50 mm = do not care, and 100 mm = definitely so).~Emax is largest effect score between 6 hours to 24 hours."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83062|NCT00975481|Primary|Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Overall drug liking VAS is one of the measures of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm= neither like nor dislike, and 100 mm= strong liking).~Emax is the largest effect score between 6 to 24 hours post-dose. Emin is the smallest effect score between 6 to 24 hours post-dose."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83063|NCT00975481|Primary|Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm).~Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis population included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.||mm||Standard Deviation|Mean
83064|NCT00975416|Other Pre-specified|Drug Craving|Cocaine Craving Questionnaire|Post-treatment||||||
83065|NCT00975416|Primary|Therapeutic Alliance|"Penn Helping Alliance Questionnaire containing 19 questions with possible scores from 19(low therapeutic alliance)-114(high therapeutic alliance).~Working Alliance Inventory containing 36 questions with possible scores from 36(low therapeutic alliance)-252 (high therapeutic alliance)."|Post 12 weeks treatment with cognitive behavioral therapy|Number of participants for analysis was determined by the number of participants who had post-treatment outcome measures.||units on a scale||Standard Deviation|Mean
83090|NCT00975195|Secondary|Change in On-treatment FEV1 as Measured by Home Based Spirometry|Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set||Litres||Standard Error|Least Squares Mean
83066|NCT00975286|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
83067|NCT00975286|Secondary|Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline DTSQ assessment during on-treatment period. Missing data was imputed using LOCF.||units on a scale||Standard Error|Least Squares Mean
83068|NCT00975286|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-blind Period|Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
83069|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
83070|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
83071|NCT00975286|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
83072|NCT00975286|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period. Missing data was imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
83073|NCT00975286|Secondary|Change From Baseline in Average Insulin Glargine Daily Dose at Week 24|Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline insulin glargine dose assessment during on-treatment period. Missing data was imputed using LOCF.||units per day||Standard Error|Least Squares Mean
83074|NCT00975286|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period. Missing data was imputed using LOCF.||kilogram||Standard Error|Least Squares Mean
83075|NCT00975286|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period. Missing data was imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
83076|NCT00975286|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period. Missing data was imputed using LOCF.||mmol/L||Standard Error|Least Squares Mean
83077|NCT00975286|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period. Missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
83078|NCT00975286|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. Last observation carried forward used.||percentage of hemoglobin||Standard Error|Least Squares Mean
83079|NCT00975221|Secondary|Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).||percent change||Standard Error|Least Squares Mean
83080|NCT00975221|Secondary|Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).||percent change||Standard Error|Least Squares Mean
83081|NCT00975221|Secondary|Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.||percentage of participants|||Number
83082|NCT00975221|Primary|Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP||Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.||percentage of participants|||Number
83083|NCT00975195|Secondary|Change in On-treatment Physician Global Evaluation|"Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
83084|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
83085|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
83091|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “extremely/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
83092|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “a lot/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
83093|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “a lot/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
83094|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “extremely/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q||units on a scale||Standard Error|Least Squares Mean
83095|NCT00975195|Secondary|Change in On-treatment BODE Index|Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
83096|NCT00975195|Secondary|Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)|Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set||meters||Standard Error|Least Squares Mean
83097|NCT00975195|Secondary|Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)|Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set||kg/m2||Standard Error|Least Squares Mean
83098|NCT00975195|Secondary|Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale|"Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.~Scale from 0 to 4:~0 = not troubled by breathlessness, except during strenuous exercise~1 = short of breath when hurrying or walking up a slight hill~2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace~3 = stops for breath after approximately 100 yards, or after a few minutes on the level~4 = too breathless to leave the house, or breathless when dressing or undressing~No breathlessness was given a score of -1~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 18 and 52 visits|Treated set||units on a scale||Standard Error|Least Squares Mean
83099|NCT00975195|Secondary|Change in On-treatment Lung Function as Measured by Trough FEV1|Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18 and 52 visits|Treated set||Litres||Standard Error|Least Squares Mean
83100|NCT00975195|Secondary|Severity of On-treatment COPD Exacerbations|Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
83101|NCT00975195|Secondary|Proportion of Patients With at Least One On-treatment COPD Exacerbation|Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
83102|NCT00975195|Secondary|Number of On-treatment COPD Exacerbations|"Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.~Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set||exacerbations per patient-year||95% Confidence Interval|Mean
83104|NCT00975195|Secondary|Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.|Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
83105|NCT00975195|Secondary|Number of Severe On-treatment COPD Exacerbations|"Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set||exacerbations per patient-year||95% Confidence Interval|Mean
83106|NCT00975195|Secondary|Time to First Severe On-treatment COPD Exacerbation|"Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set||days||95% Confidence Interval|Number
83107|NCT00975195|Secondary|Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation|Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.|During randomised treatment, up to 488 days|Treated set||percentage of participants|||Number
83108|NCT00975195|Secondary|Number of Moderate or Severe On-treatment COPD Exacerbations|"Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.~Measured values show adjusted mean event rate."|During randomised treatment, up to 488 days|Treated Set||exacerbations per patient-year||95% Confidence Interval|Mean
83109|NCT00975195|Primary|Time to First Moderate or Severe On-treatment COPD Exacerbation|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set||days||95% Confidence Interval|Number
83110|NCT00975156|Secondary|6 Minute Walking Distance (6MWD)||Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention|||meters (m)||Standard Deviation|Mean
83111|NCT00975156|Primary|10-meter Walking Test (10mWT)||Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention|Analysis was determined per protocol (i.e.between-group variation)||meters per second (m/s)||Standard Deviation|Mean
83112|NCT00975143|Primary|Co-Primary Outcome 2: Proportion of Patients Who Achieve at Least a 90% Reduction in Total Number of Nodular Lesions (Facial and Truncal).|"The percentage of patients in each group who achieved ≥90% reduction in the total nodular lesion count from Baseline to Week 20 was calculated along with its 95% CI (normal approximation). A 95% 2-sided CI on the difference between treatments (CIP-ISOTRETINOIN minus Isotretinoin) was also computed.~Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference > -10."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.||percentage of participants||95% Confidence Interval|Number
83113|NCT00975143|Secondary|Proportion of Patients Who Are Rated as Clear/Almost Clear on the Six-point Physicians' Global Assessment Scale (PGSA).|PGSA categories: 1 (Almost clear); 2 (Mild); 3 (Moderate); 4 (Severe); 5 (Very severe). A grade of either 0 (clear) or 1 (almost clear) on the 6-point PGSA scale within the Week 20 analysis window was considered a success.|20 weeks|Analysis based on the Per Protocol (PP) Population. Patients with a Baseline PGSA score of 0 or 1 (i.e., who had primarily truncal lesions at Baseline) were excluded from the analysis, as PGSA evaluated facial lesions.||percentage of participants||95% Confidence Interval|Number
83209|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83114|NCT00975143|Primary|Co-primary Outcome 1: Change From Baseline in Total Nodular Lesion Count (Facial and Truncal)|"The change from Baseline to Week 20 in the total number of nodular lesions was calculated as the Week 20 lesion count minus Baseline lesion count and compared using Analysis of Covariance (ANCOVA), controlling for Baseline total nodular lesion count, gender and analysis site.~The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was also calculated using the ANCOVA model.~Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference < 4."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.||Lesions||Standard Deviation|Mean
83115|NCT00975130|Secondary|Percentage of Participants Achieving Remission|Remission was defined as achievement of a DAS28-ESR < 2.6.|Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.||Percentage of Participants||95% Confidence Interval|Number
83116|NCT00975130|Secondary|Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12|"The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time.~The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale."|End of Month 6, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.||Units on a Scale||Standard Deviation|Mean
83117|NCT00975130|Secondary|Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8|The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score <=31 representing an acceptable PASS.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
83118|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
83119|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
83120|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83220|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83121|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83122|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
83123|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83124|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83125|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83126|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83142|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83127|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83128|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83129|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83130|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83131|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83132|NCT00975130|Secondary|Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6|Concomitant MTX dose was defined as low < 10mg/wk, medium >= 10 to < 15 mg/week, and and high >=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83133|NCT00975130|Secondary|Number of Participants Who Achieved Minimal or Absence of Functional Impairment|The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of <=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
83134|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
83135|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
83136|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83137|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83138|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
83139|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83140|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83141|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83423|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Bilirubin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83143|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83144|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83145|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83146|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83147|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83148|NCT00975130|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83149|NCT00975130|Secondary|Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6|The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as >= 2.6 to 3.2, and remission was defined as a DAS28-ESR <2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP >=2.6 to 3.2, and remission was defined as DAS28-CRP >2.6. Low disease activity by SDAI was defined as SDAI >5.0 to <=20, and remission was defined as SDAI <=5.0.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
83150|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-CRP EULAR Response|DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
83151|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-ESR EULAR Response|EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Participants|||Number
83152|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83153|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83154|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83155|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83156|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
83157|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83158|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83424|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Creatinine|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83159|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83160|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83161|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83162|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83163|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83164|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0 cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83165|NCT00975130|Secondary|Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83425|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Urea|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83166|NCT00975130|Secondary|Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83167|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83168|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
83169|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83170|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83171|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
83172|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83173|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83174|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83175|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83176|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP > 5.1 = high disease activity, DAS28-CRP < 3.2 to < =5.1 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83177|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83178|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83179|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83222|NCT00975130|Secondary|Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83180|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts & swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP >5.1 =high disease activity, DAS28-CRP <3.2=low disease activity, and DAS28-CRP <2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83181|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83182|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83183|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83184|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83185|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83186|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
83187|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83188|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83189|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83190|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83191|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83192|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR >5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83193|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83223|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83194|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83195|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83196|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83197|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
83198|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Units on a Scale||Standard Deviation|Mean
83199|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83200|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83224|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83201|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
83202|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83203|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83204|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR or at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83205|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83206|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83207|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83208|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83221|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of > 3.2 to <=5.1 indicate moderate disease activity and DAS28-ESR scores of > 5.1 indicate high disease activity.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83210|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83211|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83212|NCT00975130|Secondary|Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83213|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83214|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83215|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83216|NCT00975130|Secondary|Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||mg/L||Standard Deviation|Mean
83217|NCT00975130|Secondary|Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83218|NCT00975130|Secondary|Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83219|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83225|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83226|NCT00975130|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mg/L||Standard Deviation|Mean
83227|NCT00975130|Secondary|Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83228|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83229|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83230|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83231|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||mm/h||Standard Deviation|Mean
83232|NCT00975130|Secondary|Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83233|NCT00975130|Secondary|Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83234|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83235|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83236|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83237|NCT00975130|Secondary|Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83238|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83239|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83240|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83241|NCT00975130|Secondary|Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||mm/h||Standard Deviation|Mean
83242|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83243|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83244|NCT00975130|Secondary|mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83262|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83245|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83246|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Score on a Scale||Standard Deviation|Mean
83247|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83248|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83249|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83250|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83251|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83252|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83300|NCT00974974|Primary|"Percentage of Off Time During Waking Hours at End of Study"|"Percentage of off time during waking hours at end of study is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects||percentage of waking hours||Standard Deviation|Mean
83253|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83254|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83255|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83256|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Score on a Scale||Standard Deviation|Mean
83257|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83258|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83259|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83260|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83261|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Tender Joints||Standard Deviation|Mean
83263|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83264|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83265|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83266|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83267|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83268|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83269|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83270|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83271|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Tender Joints||Standard Deviation|Mean
83272|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83301|NCT00974818|Primary|Response to Treatment|will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.|2 years|Due to a lack of patients accrued to the protocol the protocol was closed and the analysis of the 2 year relapse rates could not be compared.||participants|||Number
83273|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83274|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83275|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83276|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.||Swollen Joints||Standard Deviation|Mean
83277|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83278|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83279|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83280|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83281|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83282|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83283|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83284|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83285|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83286|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week). A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.||Swollen Joints||Standard Deviation|Mean
83287|NCT00975130|Primary|Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12|The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6.|Start of Month 11, End of Month 12|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.||Participants|||Number
83288|NCT00975130|Primary|Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6|EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units|Month 6|The Efficacy Evaluable population in Part 1 of the study excluded participants without a DAS28-ESR at baseline and at least 1 post-line value DAS28-ESR or those that had very poor data quality due to incomplete documentation.||Participants|||Number
83289|NCT00975000|Secondary|Time to Parathyroidectomy||56 weeks|Full analysis set who underwent a parathyroidectomy|||||
83290|NCT00975000|Secondary|Percentage of Participants With a Parathyroidectomy||56 weeks|Full analysis set||percentage of participants|||Number
83291|NCT00975000|Secondary|Change From Baseline to the EAP in Urine Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data||mg/dL||Standard Deviation|Mean
83292|NCT00975000|Secondary|Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set||pg/mL||Standard Deviation|Mean
83293|NCT00975000|Secondary|Change From Baseline to the EAP in Corrected Total Calcium||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set||mg/dL||Standard Deviation|Mean
83294|NCT00975000|Secondary|Change From Baseline to Week 52 in eGFR|eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Baseline and Week 52|Full analysis set with available data||mL/min/1.73 m²||Standard Deviation|Mean
83295|NCT00975000|Secondary|Change From Baseline to the EAP in Mean Serum Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data||mg/dL||Standard Deviation|Mean
83296|NCT00975000|Secondary|Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck|Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).|Baseline and Week 52|Full analysis set with available data||percent change||Inter-Quartile Range|Median
83297|NCT00975000|Primary|Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)||Weeks 21 to 26 (EAP)|Full analysis set (all randomized participants excluding participants determined to have graft failure prior to week 26)||percentage of participants|||Number
83298|NCT00974974|Secondary|"On Time Without Troublesome Dyskinesia"|"On time without troublesome dyskinesiais measured by using the Parkinson's disease diary. On time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."|22 weeks|All randomized subjects||Hours||Standard Deviation|Mean
83299|NCT00974974|Secondary|"Off Time Hours"|"Off time hours is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects||Hours||Standard Deviation|Mean
83478|NCT00972205|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months|||Participants|||Number
83302|NCT00974571|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83303|NCT00974571|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83304|NCT00974571|Secondary|Mean Change From Baseline in Composite Symptoms Score|Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.||Score 0 (best) to 3 (worst)||95% Confidence Interval|Least Squares Mean
83305|NCT00974571|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83306|NCT00974571|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 4 weeks of a 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83307|NCT00974480|Secondary|Tolerance Evaluated by Investigator.|"Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale.~Scaling, Dryness and Erythema Evaluations~- None (0) - Very Severe = (4)~Burning and Itching Evaluation Scale~None (0) = Normal, no discomfort~Mild (1) = Slight discomfort that is not bothersome~Moderate (2) = Discomfort that is somewhat bothersome~Marked (3) = Discomfort that is bothersome and that occasionally interferes with normal daily activities~Severe (4) = Continuous discomfort that interferes with normal daily activities"|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
83308|NCT00974480|Secondary|Facial Skin Self-evaluation.|A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
83309|NCT00974480|Secondary|Sensitivity of the Face Evaluated by Subject.|"Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately.~Each score is from 0 = absent to 10 important."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
83310|NCT00974480|Secondary|Clinical Skin Evaluation.|A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
83311|NCT00974480|Secondary|Area Ratio - Analysis of Skin Replicas of Crow's Feet.|An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling.|24 weeks|Only the per protocol (PP) population was considered for this analysis. Early termination and lost subjects were excluded from this analysis. Furthermore, some replicas of subjects who completed the study could not be analyzed with precision and were consequently excluded from the analysis by the laboratory.||mm²||Standard Deviation|Mean
83312|NCT00974480|Secondary|Skin Elasticity.|Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||kilo Pascals||Standard Deviation|Mean
83313|NCT00974480|Secondary|Skin Hydration (Conductance)|"Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe.~Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||µsiemens (µmho)||Standard Deviation|Mean
83541|NCT00971243|Secondary|Adverse Events, Laboratory Tests, Vital Signs, Etc.||Weeks 24, 52||||||
83314|NCT00974480|Secondary|Trans-epidermal Water Loss (TEWL).|Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||g / m² / h||Standard Deviation|Mean
83315|NCT00974480|Secondary|Photographic Evaluation by a Panel of Blinded Dermatologists.|"A blinded panel of two dermatologists had to identify independently which of the two photographs had an improvement or if there was no noticeable difference between them. The two photographs of each subject were randomized to keep the blind.~When the Week 24 photograph was selected as the one showing an improvement, it was scored by the statistician as “improvement”. When the Day 0 photograph was selected as the one showing an improvement, it was scored by the statistician as “worsening”. When there was no noticeable difference between the photographs, it was scored as “stable”."|24 weeks|Analysis was intent to treat (ITT). Photographs taken at early termination visit were not available for every early termination subject as some subjects refused to have their photographs taken. Thus, early termination and lost to follow-up subjects were excluded from this analysis. The total number of subjects included in the ITT analysis was 92.||Participants|||Number
83316|NCT00974480|Primary|Skin Aging Measured With the Photonumeric Scale.|Scoring was accomplished by matching each part of the face (forehead, glabella, corners of the mouth, nasal labial fold, crow's feet, below eyes and upper lip) to photographs in the scales and reporting the appropriate number in the tables. All individual scores were added to obtain the total score (Less signs of skin aging = 0, more signs of skin aging = 41.6).|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.||Units on a scale||Standard Deviation|Mean
83317|NCT00974311|Secondary|Circulating Tumor Cell (CTC) Conversion Rate|RESULTS FOR CTC WILL BE REPORTED IN 2014|During study period (up to 3 years)||||||
83318|NCT00974311|Secondary|European Quality of Life Five-Domain Scale (EQ-5D)|"RESULTS FOR EQ-5D WILL BE REPORTED in Q4 2013.~The EQ-5D is a standardized instrument for use as a measure of quality of life. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scales ranging from “no problem” to “severe problem.” Higher scores reflect worse quality of life."|At Week 13 visit||12/2013||||
83319|NCT00974311|Secondary|Percentage of Patients With Soft-tissue Objective Response|"The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the Investigators’ response assessments and also the derived response assessments by treatment group. Only patients with measurable soft tissue disease at screening were included in this analysis. Patients with measurable disease at screening are patients who had at least 1 target lesion identified per RECIST v1.1 at screening.~Percentage of Participants summarizes the number of patients with complete or partial objective response (%).~Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247."|During study period (up to 3 years)|Intent to Treat (ITT) with Measurable Disease. Patients who were part of the ITT Population and had measurable soft tissue disease at screening, defined by at least 1 target lesion according to RECIST v1.1.||Percentage of participants|||Number
83320|NCT00974311|Secondary|Percentage of Patients With Prostate Specific Antigen (PSA) Response|Patients were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.|During study period (up to 3 years)|Evaluable Intent to Treat. Patients who were part of the ITT Population and had a PSA level measured at baseline and at least 1 post-baseline assessment.||Percentage of Participants|||Number
83321|NCT00974311|Secondary|Percentage of Patients With Pain Palliation|The proportion of patients with pain palliation was assessed for patients with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as ≥ 30% reduction in average pain score at Week 13 compared to baseline without a ≥ 30% increase in analgesic use.|During study period (up to 3 years)|Evaluable ITT Population. Patients with metastatic bone disease at baseline; provided answers to Question #3 of the Brief Pain Inventory – Short Form for a minimum of 4 out of 7 days in the baseline run-in period; stable baseline pain; stable analgesic use; and had an average pain score during the baseline run-in period of ≥ 4.||Percentage of Participants||95% Confidence Interval|Number
83322|NCT00974311|Secondary|Time to Prostate-specific Antigen (PSA) Progression|"Time to PSA progression was defined as time from randomization to PSA progression. Patients who did not reach the endpoint were right censored at their last assessment or for patients with no post-baseline PSA assessment, date of randomization.~For patients with PSA declines at Week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For patients with no PSA declines at Week 13, PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment)."|Baseline and at every study visit from week 13 while on study drug (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
83353|NCT00973700|Secondary|HI GMR, in Adults 18 to 64 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.||Ratio||95% Confidence Interval|Geometric Mean
86077|NCT00945893|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1||Days 1-8|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
83323|NCT00974311|Secondary|Functional Assessment of Cancer Therapy - Prostate (FACT-P)|"The FACT-P questionnaire is a 39-item questionnaire consisting of 5 domains; “physical well-being,” “social/family well-being,” “emotional well-being,” “functional well-being,” and “additional concerns” (consisting of items relating to prostate cancer and its treatment). Each item can be answered on a scale of 0–4. The sum of scores on all 5 domains constitutes the FACT-P.~Patients were defined as having a quality of life response if they had a 10-point improvement in their global FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart."|During study period (up to 3 years)|Evaluable Intent to Treat (ITT) - all patients who were part of the ITT Population and had a global FACT-P score at baseline and at least 1 post-baseline assessment.||Percentage of participants||95% Confidence Interval|Number
83324|NCT00974311|Secondary|Time to First Skeletal-related Event|The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Patients were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Patients who did not reach the endpoint were right censored at their last assessment.|During study period (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
83325|NCT00974311|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Patients were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by RECIST 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Patients who did not reach the endpoint were right censored at their last assessment.|During study period (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
83326|NCT00974311|Primary|Overall Survival|Survival is defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for patients who were lost to follow-up since randomization or not known to have died at the data analysis cutoff date (this included patients who were known to have died after the data analysis cutoff date).|During study period (up to 3 years)|Intent to Treat (ITT) - All Patients Randomized||Months||95% Confidence Interval|Median
83327|NCT00974246|Primary|Pulmonary Function FEC/FVC Ratio at 16 Weeks|To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration.|16 weeks|||ratio||Standard Deviation|Mean
83328|NCT00974246|Primary|To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment.|FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks|||units on a scale||Standard Deviation|Mean
83329|NCT00974246|Primary|To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0|The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks|||units on a scale||95% Confidence Interval|Mean
83330|NCT00974220|Secondary|Cycle Exercise Endurance Time|Constant workrate cycle endurance during tests at 75% of the peak incremental workrate|10-minutes post-treatment|Subjects completing both treatment arms were included in this analysis||minutes||Standard Error|Mean
83331|NCT00974220|Primary|Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise|"The 10-point Borg scale ranges from 0 nothing at all to 10 maximal/extremely strong and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests."|10-minutes post-treatment|Subjects who completed both treatment arms of the crossover study were included in the primary analysis.||units on a scale||Standard Error|Mean
83332|NCT00974090|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
83333|NCT00974090|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg・hr/dL||Standard Error|Least Squares Mean
83334|NCT00974090|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
83335|NCT00974090|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||percentage of HbA1c||Standard Error|Least Squares Mean
83336|NCT00974051|Primary|Blood Glucose Nadir|BG nadir overnight after intervention|overnight hours|||mg/dl||Standard Deviation|Mean
83337|NCT00974051|Secondary|Percent of Nighttime Glucose Levels >250 mg/dl||10:00pm to 6:00am|||percentage of overnght glucose values|||Number
83338|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <70||10:00pm to 6:00am|||percentage of nighttime glucose values|||Number
83339|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <80||9:00pm to 6:00am|||percentage of overnight glucose levels|||Number
83340|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the QCA and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||mm||Standard Deviation|Mean
83341|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||percentage of correct decision by QCA|||Number
83342|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||mm||Standard Deviation|Mean
83343|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On the procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.||percentage of correct decisions by SO|||Number
83344|NCT00973765|Primary|Treatment Failures at 7 Days|worsening abscess or new recurrence of abscess|7 days|||participants|||Number
83345|NCT00973739|Secondary|Participants Experiencing Grade 3 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year|||participants|||Number
83346|NCT00973739|Secondary|Participants Experiencing Grades 1 or 2 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year|||participants|||Number
83347|NCT00973739|Secondary|Estimated Volumetric Progression Free Survival for Hearing at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of hearing progression. PFS was analyzed using the Kaplan–Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.~Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan–Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
83348|NCT00973739|Primary|Estimated Volumetric Progression Free Survival at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of volumetric progression. PFS was analyzed using the Kaplan–Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.~Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan–Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
83349|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).~Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.~The analyses were performed on the safety set."|7 days after each vaccination|The analysis is done on the safety set.||Number of subjects|||Number
83350|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).~Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.~Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination."|7 days after each vaccination|The analysis is done on the safety set.||Number of subjects|||Number
83351|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).~Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination"|7 days after each vaccination|The analysis is done on the safety set.||Number of subjects|||Number
83352|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the per-protocol set (PPS)."|7 days and 21 days after each vaccination|The analysis is done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
83355|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
83356|NCT00973700|Secondary|Age Distribution at Baseline||Baseline|The overall number of baseline participants.||years||Standard Deviation|Mean
83357|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~Analyses were performed on the Per-Protocol set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
83358|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.||Percentages of Subjects||95% Confidence Interval|Number
83359|NCT00973622|Primary|A Difference Score for the Log Value of K.|K is a output value, a summary statistic, derived from a hyperbolic function that summarizes the rate at which monetary values are discounted according to the time they are received. The value of K can either increase or decrease from its baseline value. For example, an increase in K would indicate that the participant is choosing to receive larger amounts of money at a later point in time. A decrease would suggest the opposite - lesser amounts of money at an earlier point in time). The difference score is calculated from baseline to that immediately after 10 or 20 Hz rTMS.|baseline and immediately after stimulation, an average of 25 seconds.|All participants that attended at least one session and provided at least some outcome data were included in the analyses||log transformed values of K||Standard Deviation|Log Mean
83360|NCT00973479|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.|Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Scores on a scale||Standard Deviation|Mean
83361|NCT00973479|Secondary|Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Percentage of Participants|||Number
83362|NCT00973479|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Scores on a scale||Standard Deviation|Mean
83363|NCT00973479|Secondary|Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14|"DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant’s global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score >1.2 is being referred to as a good response and a decrease of 0.6-1.2 as a moderate response."|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Percentage of Participants|||Number
83364|NCT00973479|Primary|Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 [no pain] to 10 [worst pain]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.||Percentage of Participants|||Number
83365|NCT00973362|Secondary|ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)|ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay|Baseline Evaluation|74 women with Aptima HPV assay results did not have FDA-Approved HPV DNA test results primarily due to insufficient volume of the cytology specimen for an N of 865 results for the FDA-Approved HPV DNA assay compared to 939 results for the Aptima HPV assay.||participants|||Number
83366|NCT00973362|Secondary|ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)|ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)|Baseline Evaluation|||participants|||Number
83367|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct Study Arm: 30+ yrs. Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation|18 women with Aptima HPV results did not have FDA-Approved DNA test results due to insufficient volume of the cytology specimen for a N of 801 compared to a N of 819 for the Aptima HPV assay results.||participants|||Number
83368|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation|||participants|||Number
83369|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.||Participants|||Number
83370|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.||Participants|||Number
83371|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.||Participants|||Number
83372|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The population used in analysis was the safety set||Participants|||Number
83373|NCT00973349|Secondary|Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.|21 days after vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CHMP criteria, 18 to 60 years and over 60 years of age.||Geometric Mean Ratio||95% Confidence Interval|Geometric Mean
83374|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.||Participants|||Number
83375|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age|Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.||Participants|||Number
83376|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.||Participants|||Number
83377|NCT00973349|Secondary|Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age|Geometric mean hemagglutinin inhibition (HI) titer = GMT|21 days after each vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CBER criteria, 18 to 64 years and over 64 years of age.||Geometric Mean Titer||95% Confidence Interval|Geometric Mean
83378|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age|Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was based on the per protocol population.||Participants|||Number
83379|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): bone formation marker [bone-specific alkaline phosphatase (bALP) ].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||U/L||Full Range|Median
83380|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA) bone formation marker [bone-specific alkaline phosphatase (bALP)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||U/L||Full Range|Median
83426|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Potassium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83381|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery) after 18 months post VD|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
83382|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related events (SRE: pathologic fractures, need for bone radiation therapy or surgery) following 8 cycles (day 168) of therapy|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
83383|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] every 6 months for up to 18 months|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
83384|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||participants|||Number
83385|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 8 (day 168).~Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The VAS for Bone Pain was constructed as follows:~None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||units on a scale||Full Range|Median
83386|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 4 (day 84).~Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The VAS for Bone Pain was constructed as follows:~None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||units on a scale||Full Range|Median
83387|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 8 (day 168) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation marker [osteocalcin (OC)].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||ng/ml||Full Range|Median
83388|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation markers [osteocalcin (OC)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||ng/ml||Full Range|Median
83389|NCT00972959|Secondary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1–L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||T-score||Full Range|Median
83390|NCT00972959|Primary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1–L4, anteroposterior view) and femoral neck (FN) was measured by dual energy X-ray absorptiometry (DXA) using a Hologic QDR-1000 scanner on day 21 of cycle 4 (day 84)|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)||T-scores||Full Range|Median
83391|NCT00972816|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AEs)|Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)|Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination|The analysis was done on unsolicited safety set population.||Subjects|||Number
83392|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination|Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)|7 days after second vaccination|The analysis was performed on safety set population||Participant|||Number
83393|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination|Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).|7 days after first vaccination|The analysis was performed on safety set population||Participants|||Number
83395|NCT00972816|Secondary|Antibody Response Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.~Subgroups with baseline HI titer < 1:10: PPS Day 1–29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.~Subgroups with baseline HI titer ≥ 1:10: PPS Day 1–29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29 and Day 43|||percentage of Subjects||95% Confidence Interval|Number
83396|NCT00972816|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|"Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines~Subgroups without recent seasonal flu vaccine:~PPS Day 1, Day 1–22 and Day 1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.~Subgroups with recent seasonal flu vaccine:PPS Day 1–22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.~PPS Day 1–29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively"|Day 1, Day 22, Day 29, Day 43|The analysis was done on PPS population.||Titers||95% Confidence Interval|Geometric Mean
83397|NCT00972816|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.|HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1–22 and Day1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.|Day 22, Day 29, Day 43|The analysis was done on PPS population||percentage of Subjects||95% Confidence Interval|Number
83398|NCT00972816|Secondary|Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group|"Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.~PPS Day1–29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1–202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population||Titers||95% Confidence Interval|Geometric Mean
83399|NCT00972816|Primary|Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations|"HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.~PPS Day 1–29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.~PPS Day 1–202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1–387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population||percentage of subjects||95% Confidence Interval|Number
83400|NCT00972777|Secondary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 3|Microbial Eradication at Visit 3, (LOCF), mITT Population.||eyes|||Number
83401|NCT00972777|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 3|Clinical Resolution at Visit 3, (LOCF) mITT Population.||eyes|||Number
83402|NCT00972777|Primary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 2|Microbial Eradication at Visit 2, (LOCF), mITT Population.||eyes|||Number
83403|NCT00972777|Primary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 2|Clinical Resolution at Visit 2, (LOCF), mITT Population.||eyes|||Number
83404|NCT00972738|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period|Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.|Baseline and at the end of 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and a week 2 measurement were included. No missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83405|NCT00972738|Secondary|Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83427|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Sodium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83406|NCT00972738|Secondary|Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83407|NCT00972738|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83408|NCT00972738|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83409|NCT00972738|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
83410|NCT00972621|Secondary|Postoperative Mean Endothelial Cell Count|mean endothelial cell count (measured by Konan specular microscope) at 3 months|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting mean endothelial cell count for ITT population, which differs from the safety population used in the Participant Flow.||number of endothelial cells||Standard Deviation|Mean
83411|NCT00972621|Primary|Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively|Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting IOP spikes ≥ 30 mmHg for ITT population, which differs from the safety population used in the Participant Flow.||percent rate of IOP spikes||90% Confidence Interval|Number
83412|NCT00972595|Primary|Peak Plasma Concentration (Cmax) for Ondansetron||24 hours post-dose|All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis.||ng/mL||Standard Deviation|Least Squares Mean
83413|NCT00972595|Primary|Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose|All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis.||ng*hr/mL||Standard Deviation|Least Squares Mean
83414|NCT00972543|Secondary|Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)|||participants|||Number
83415|NCT00972543|Secondary|Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)|||participants|||Number
83416|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - C Reactive Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83417|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83418|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83419|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alanine Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83420|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Aspartate Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83421|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Calcium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83432|NCT00972543|Secondary|Haematology Laboratory Assessments - Neutrophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83433|NCT00972543|Secondary|Haematology Laboratory Assessments - Platelets|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83434|NCT00972543|Secondary|Haematology Laboratory Assessments - White Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83435|NCT00972543|Secondary|Haematology Laboratory Assessments - Red Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83436|NCT00972543|Secondary|Haematology Laboratory Assessments - Haematocrit|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83437|NCT00972543|Secondary|Haematology Laboratory Assessments - Haemoglobin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|||participants|||Number
83438|NCT00972543|Secondary|Weight Measurements||Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
83439|NCT00972543|Secondary|Temperature||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study|||||
83440|NCT00972543|Secondary|Arterial Blood Pressure||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study|||||
83441|NCT00972543|Secondary|Heart Rate||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study|||||
83442|NCT00972543|Secondary|Complaint Directed Physical Examinations|Number of participants undergoing complaint directed physical examinations|Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)|Results not analysed due to early termination of the study|||||
83443|NCT00972543|Secondary|Participants With Direct Physical Examination Abnormalities|Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum|Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits|Results not analysed due to early termination of the study|||||
83444|NCT00972543|Primary|Dynamic Physician's Global Assessment of Change (dPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
83445|NCT00972543|Primary|Static Physician Global Assessment (SPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Screening, Day 0 and Day 7|Results not analysed due to early termination of the study|||||
83446|NCT00972543|Primary|Psoriasis Area and Severity Index (PASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
83447|NCT00972543|Primary|Static Physician Global Assessment Hands and Feet (sPGA – H&F)|Minimum possible score 0, maximum possible score 4.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit|Results not analysed due to early termination of the study|||||
83448|NCT00972543|Primary|Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study|||||
83449|NCT00972530|Primary|Relapse of Arthritis|The patients were followed for six months and if signs and symptoms recurred in between the patients were told to contact the rheumatology department. In such cases the elbow was re-examined and if a relapse could be confirmed the duration of effect was recorded and if needed the patient was offered another injection.|Regular visits at one week, 3 months and 6 months.|||participants|||Number
83450|NCT00972478|Secondary|Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to week 26|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
83451|NCT00972478|Secondary|Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to week 26|Eligible patients who received the protocol treatment in the Phase II portion of the study||percentage of participants||95% Confidence Interval|Number
83452|NCT00972478|Secondary|Overall Survival (Phase II)|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.||percentage of participants||95% Confidence Interval|Number
83453|NCT00972478|Primary|Progression-free Survival (Phase II)|From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.||percentage of participants||95% Confidence Interval|Number
83454|NCT00972478|Primary|Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)|Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|21 days|Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).||mg PO Once daily Days 1-9|||Number
83455|NCT00972374|Other Pre-specified|Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit|IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.|12 Months|Intent to Treat: all randomized patients||Percentage of Patients|||Number
83456|NCT00972374|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 3|Intent to Treat: all randomized patients||Number of Letters Read Correctly||Standard Deviation|Mean
83457|NCT00972374|Primary|Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.|Month 3|Intent to Treat: all randomized patients||Percentage of Patients|||Number
83458|NCT00972335|Secondary|To Correlate the Activity of This Treatment Regimen With Expression of Selected Intra-tumoral Biomarkers.||18 months||||||
83459|NCT00972335|Secondary|To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.||18 months|Includes all treated patients (one patient not treated)||participants|||Number
83460|NCT00972335|Primary|Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma.|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined per MacDonald criteria for response as ≥25% increase in size of enhancing tumor or any new tumor on MRI scan, neurologically worse, and steroids stable or increased.|18 months|Includes all enrolled and treated patients (one patient not treated)||months||95% Confidence Interval|Median
83461|NCT00972322|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Day 28|All participants who received at least one dose of the investigational drug.||Participants|||Number
83462|NCT00972322|Primary|Number of Participants Who Experienced Serious or Non-serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to Day 31|All participants who received at least one dose of the investigational drug.||Participants|||Number
83463|NCT00972322|Primary|Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose."|Baseline and Day 28|All participants who were compliant with the study procedures and have available data from at least one treatment were included in the primary analysis dataset.||mg/dL||Standard Deviation|Least Squares Mean
83464|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
83465|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Episodes/100 years of patient exposure|||Number
83466|NCT00972283|Primary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject’s daily activities. Moderate AEs: marked symptoms, moderate interference with subject’s daily activities. Severe AEs: considerable interference with subject’s daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
83467|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
83468|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 78 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.||Episodes/100 years of patient exposure|||Number
83469|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78|Mean of the SMPG at 78 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am, before breakfast.|Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
83470|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.||mmol/L||Standard Deviation|Mean
83471|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment|Change from baseline in HbA1c after 78 weeks of treatment|Week 0, Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF||percentage of glycosylated haemoglobin||Standard Deviation|Mean
83472|NCT00972283|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF)||percentage of glycosylated haemoglobin||Standard Deviation|Mean
83473|NCT00972244|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy|At Week 12|Full Analysis Set, participants with non-missing baseline and week 12 (LOCF) values||Percentage of participants|||Number
83474|NCT00972244|Secondary|Adjusted Mean Change in Fasting Plasma Glucose|Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
83475|NCT00972244|Primary|Adjusted Mean Change in HbA1c Levels|The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values||percent||95% Confidence Interval|Least Squares Mean
83476|NCT00972205|Secondary|Number of Participants Who Had an Overall Response|"Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR)-disappearance of all target lesions, Partial response (PR)-at least a 30% decrease in the sum of the longest diameter(LD)of target lesions, stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.~See the Protocol Link module for further details about the RECIST Criteria."|Baseline to progression|||participants with response|||Number
83477|NCT00972205|Secondary|Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment|Rhodamine 123 was added to whole blood obtained before and after CBT-1. The blood was incubated, layered on lymphocyte separation medium and centrifuged. Peripheral blood mononuclear cells(PBMCs)were isolated, washed and incubated in rhodamine-free medium with or without valspodar. Cells were washed and incubated in phycoerythrin-labeled anti-CD56 antibody or negative control antibody. Rhodamine 123 fluorescence was assessed in CD56+cells with or without valspodar and a 60 min efflux period,continuing the cells without or with valspodar to generate Efflux and PSC/Efflux histograms.|Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing.|Rhodamine 123 fluorescence was assessed in CD56+cells after a 30 min loading period with or without exogenously added valspodar and a 60 min efflux period followed, continuing the cells with or without exogenous valspodar to generate Efflux and PSC/Efflux histograms. Percent decrease in difference between these histograms is reported.||Percent inhibition of rhodamine efflux||Full Range|Mean
83479|NCT00972205|Primary|Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition|An area under the concentration curve (AUC) was calculated for 99mTc counts over the liver, lungs, and heart. An equation was applied to determine the increase in sestamibi in the liver: [(AUCpost - AUC baseline)/(AUC baseline)] x 100.|sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration|As planned imaging data from 10 pts were analyzed.||percent increase sestamibi retention||Full Range|Median
83480|NCT00972153|Secondary|Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter|Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size >10 micrometer had the strongest correlation to the presence of CFUs at the incision site.|Ten minute intervals throughout surgery|||>10 micrometer particles / cubic meter||Full Range|Median
83481|NCT00972153|Primary|Surgery Site CFU Density|"Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol slit sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter."|Ten minute intervals throughout surgery|Airborne CFU densities were obtained in ten-minute intervals throughout each procedure. Average surgery duration was 69 minutes in the control and sham groups; 66 minutes in the experiment group. A total of 208 density readings were obtained.||CFU/cubic meter||Full Range|Median
83482|NCT00972088|Primary|Prevalence of Inflammation as Diagnosed by Capsule Endoscopy|The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.|up to 7 days|per protocol||participants|||Number
83483|NCT00972023|Secondary|Toxicity||Within 48 hours prior to surgery and after 14 days of DHEA treatment.||||||
83484|NCT00972023|Secondary|Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.||||||
83485|NCT00972023|Secondary|Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.||||||
83486|NCT00972023|Primary|Tumor Proliferation (Percentage of Ki-67 Positive Cells)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.|||||
83487|NCT00971997|Secondary|Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48|A hypoglycemic episode was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or participants had a blood glucose level below 50 mg/dL regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.||number of hypoglycemic episodes|||Number
83488|NCT00971997|Secondary|Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48|Results are reported as the percentage of participants experiencing hypoglycemia, which was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or they had a blood glucose level below 50 milligram/deciliter (mg/dL) regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.||percentage of participants|||Number
83489|NCT00971997|Secondary|Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48||Baseline and Weeks 16, 32 and 48|Participants who completed treatment through Week 48.||units of insulin/day||Standard Deviation|Mean
83490|NCT00971997|Secondary|Change From Baseline in Body Weight at Week 48 Endpoint||Baseline, Week 48|Participants who completed treatment through Week 48, and had both baseline and post-baseline value.||kilogram (kg)||Standard Deviation|Mean
83491|NCT00971997|Secondary|Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||mg/dL||Standard Deviation|Mean
83492|NCT00971997|Secondary|Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint|C-peptide is a protein that is produced in the body along with insulin.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
83493|NCT00971997|Secondary|Change From Baseline in Blood Glucose Profile at Week 48 Endpoint|Time course of changes in blood glucose was determined by 7-point self-monitoring of blood glucose (SMBG) during the day (before breakfast, lunch, and dinner, 2 hours after the start of each meal, and at bedtime).|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||mg/dL||Standard Deviation|Mean
83494|NCT00971997|Secondary|Change From Baseline in Fasting Glucose at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
83495|NCT00971997|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
83496|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 6.5% and 7.0% HbA1c are the Japan Diabetes Society (JDS) values, and are equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c values of 6.9% and 7.4%, respectively.|Week 48|Participants completed treatment through Week 48.||percentage of participants||95% Confidence Interval|Number
83497|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 7.0% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 7.4%.|Week 16 and Week 32 and Week 48|Participants received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
83498|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 16 and Week 32|Participants received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
83499|NCT00971997|Primary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 48|Participants received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
83500|NCT00971932|Secondary|Time to Treatment Failure|Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.|Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|"ITT population included all participants who received at least one dose of the study medication. Here number of participants analyzed N is signifying those participants for whom trial treatment failed."||months||95% Confidence Interval|Median
83501|NCT00971932|Secondary|Overall Survival (OS) Time|Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||months||95% Confidence Interval|Median
83502|NCT00971932|Secondary|Progression-Free Survival (PFS) Time|The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||months||95% Confidence Interval|Median
83503|NCT00971932|Secondary|Duration of Response|Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).|Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|Subgroup of participants from the study population with a best overall response (CR or PR).||months||95% Confidence Interval|Median
83504|NCT00971932|Secondary|Disease Control Rate|Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (>=50 percent decrease in sum of the products of diameters [SOPD] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease [SD] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
83505|NCT00971932|Secondary|Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
83506|NCT00971932|Primary|Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria|Percentage of participants experiencing a complete response [CR] (complete disappearance of measurable and evaluable disease without new lesions) or partial response [PR] (greater than or equal to 50 percent decrease in the sum of the products of diameters [SOPD] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).|Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011|Intention-to-treat (ITT) population included all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
86109|NCT00945243|Secondary|Implant Related Complications|Percentage of subjects who had an implant related complication|24 months|11 subjects were enrolled and treated on protocol and were thus considered for safety information||percentage of subjects|||Number
83507|NCT00971841|Secondary|Number of Participants With Complete Response to Tumor|Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).|Every 7 weeks Day 1 to 4 years|Only one participant enrolled so results are for one participant.||participants|||Number
83508|NCT00971841|Primary|Number of Adverse Events (AEs) Per Participant|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.|Weekly Day 1 to 4 years|Only one participant enrolled in the study so all results represent one participant.||adverse events|||Number
83509|NCT00971789|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events|47 months|||Participants|||Number
83510|NCT00971789|Primary|Biochemical Changes in Benign and Malignant Tumor Tissues as Assessed by Immunohistochemistry.|A biochemical change is defined as a decrease in certain protein levels (e.g. P-AKT (phosphorylated AKT), total S6, P-S6, and P-4E-BP1) important in cell growth. These are measured by collecting tissue samples which stained and protein levels are measured under the microscope. Scoring will be based on distribution and intensity of staining. Distribution will be scored as 0 (0%), 1 (1% to 50%), and 2 (51% to 100%) to indicate the percentage of positive cells of interest in a single core. The intensity of the signal will be scored as 1 (weak), 2 (moderate), and 3 (strong). The distribution score and intensity score will be summed into a total score (TS).|Baseline, day 14, and day 56|No patient underwent biopsy after the study treatment, so no such tissue analysis was done.|||||
83511|NCT00971750|Primary|Polyps on Transabdominal and Laparoscopic Ultrasound|Number of patients with polyps.|6 years|||participants|||Number
83512|NCT00971750|Secondary|Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Mean CBD diameter.|transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively|||millimeters||Standard Deviation|Mean
83513|NCT00971750|Primary|Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Number of patients with cholelithiasis.|transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively|||participants|||Number
83514|NCT00971633|Primary|Maximum Plasma Concentration (Cmax) of Ondansetron||24 hours post dose|All study participants (N=12)||nM||Standard Deviation|Least Squares Mean
83515|NCT00971633|Primary|Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose|All study participants (N=12)||nM*hr||Standard Deviation|Least Squares Mean
83516|NCT00971620|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|37 months|||participants|||Number
83517|NCT00971620|Primary|Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory|Change in worst lesional pain in the past week based on Brief Pain Inventory (BPI) from Week 0 to Week 4 in treated patients versus controls. The BPI uses an arbitrary units on a 0-10 scale. For the purposes of the statistical calculation, a difference of 1 standard deviation between groups at baseline vs. week 4 was considered significant. Any BPI value above zero (no pain) is abnormal. The mean change indicates mean change in pain score.|Up to 4 weeks|||units on a scale||Standard Error|Mean
83518|NCT00971425|Secondary|Number of Subjects With AEs of Specific Interest|Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
83519|NCT00971425|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
83520|NCT00971425|Primary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
83521|NCT00971425|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination"|During 21 days (Day 0-20) after each vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
83522|NCT00971425|Primary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain|"Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0).~The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||fold increase||95% Confidence Interval|Mean
83523|NCT00971425|Primary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
83524|NCT00971425|Primary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~The cut-off was a titer of 1:10 and this titer was considered as seropositivity."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
83525|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix|Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)|During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix|The analysis was performed on the Total Vaccinated cohort on subjects with available results.||subjects|||Number
83526|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix|Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).|During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix|The analysis was performed on the Total Vaccinated cohort on subjects with available results||subjects|||Number
83527|NCT00971425|Secondary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.~Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
83528|NCT00971425|Secondary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"For the definition of seroconversion factor, please refer to the primary outcome measure.~Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||fold increase||95% Confidence Interval|Mean
83529|NCT00971425|Secondary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
83530|NCT00971425|Secondary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"The cut-off was a titer of 1:10 and this titer was considered as seropositivity.~Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||subjects|||Number
83531|NCT00971425|Secondary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||titer||95% Confidence Interval|Geometric Mean
83532|NCT00971425|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain|"Titers were expressed as GMTs.~The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.||titer||95% Confidence Interval|Geometric Mean
83533|NCT00971295|Secondary|AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity|area under the plasma metformin concentration from time zero to infinity|3 weeks|||ng*h/mL||Standard Deviation|Mean
83534|NCT00971295|Secondary|Tmax - Time of Occurrence of Cmax|time of occurrence of maximum observed plasma metformin concentration|3 weeks|||hours||Standard Deviation|Mean
83535|NCT00971295|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum Observed Plasma Metformin Concentration|3 weeks|||ng/mL||Standard Deviation|Mean
83536|NCT00971282|Primary|Pruritus|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
83537|NCT00971282|Primary|Stinging/Burning|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
83538|NCT00971282|Primary|Dryness|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
83539|NCT00971282|Primary|Scaling|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
83540|NCT00971282|Primary|Erythema Rating Scale|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)||units on a scale||Standard Error|Mean
83542|NCT00971243|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24|Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.|Baseline and Week 24|LOCF was implemented in the ITT population analysis to replace missing values for all those subjects who did not present a FPG value at Week 24.||mg/dL||Standard Error|Least Squares Mean
83543|NCT00971243|Primary|Change in HbA1c From Baseline to Week 24|The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.|Baseline and Week 24|LOCF was implemented in the Intention-to-Treat (ITT) population analysis to replace missing values for all those subjects who did not present an HbA1c value at Week 24.||percentage of HbA1c||Standard Error|Least Squares Mean
83544|NCT00971204|Primary|Freedom From Recurrence of Atrial Fibrillation|Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.|12 months|Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint.||successful participants|||Number
83545|NCT00971048|Secondary|Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|At every visit: Day 8, Day 15, Day 22, Day 29|||BWAT-m Exudate Score||Standard Error|Least Squares Mean
83546|NCT00971048|Secondary|Pain Assessed by a 100-mm VAS Scale.|100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain)|At every visit: Day 8, Day 15, Day 22, Day 29|Intent-to-Treat||VAS Pain Scores||Standard Error|Least Squares Mean
83547|NCT00971048|Secondary|Number of Participants With Wound Closure by Day 22.||22 days|||Subjects|||Number
83548|NCT00971048|Primary|Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|22 - 29 days|Intent-to-Treat||units on a scale||Standard Error|Least Squares Mean
83549|NCT00970944|Primary|Disability Rating Scale: Functional Status|"Measure of function after traumatic brain injury (TBI) intended to measure function from coma to community. Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability)."|Randomization and weekly for 6 weeks. The primary study endpoint was week 4 and drug washout was week 6.|Analyses were conducted according to the intention-to-treat principle. 184 subjects were randomized and included for analysis. Since missing data were infrequent and unrelated to the study outcome, imputation methods were not undertaken.||units on a scale||Standard Deviation|Mean
83550|NCT00970944|Secondary|JFK Coma Recovery Scale-Revised: Neurobehavioral Status|"Measure of neurobehavioral function and clinical change for individuals with severe alterations of consciousness.~Minimum score= 0; Maximum score= 23 (Higher scores are indicative of a higher-level of neurobehavioral function)."|Week 4 (primary endpoint); Week 6 (post-washout)|Analyses were conducted according to the ITT principle so that all 184 patients randomized were included for analysis. Imputation techniques were not undertaken since missing data were infrequent and unrelated to study outcome.||units on a scale||Standard Deviation|Mean
83551|NCT00970853|Secondary|Teacher Rating Form (TRF), Total Problems|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry|||units on a scale||Standard Deviation|Mean
83552|NCT00970853|Secondary|Teacher Rating Form (TRF), Externalizing|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry|||units on a scale||Standard Deviation|Mean
83553|NCT00970853|Secondary|Teacher Rating Form (TRF), Internalizing|The TRF is the companion to the CBCL and is completed by the child’s teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child”, based on the past two months. The raw scores from the 112 items are then compared with scores from age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. value is 80; best value is 30.|8 years from study entry|||units on a scale||Standard Deviation|Mean
83554|NCT00970853|Secondary|Child Behavior Checklist (CBCL),Total Problems|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30."|8 years from study entry|||units on a scale||Standard Deviation|Mean
83555|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Externalizing|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. The worst possible score is 80 and the best possible score is 30."|8 years from study entry|||units on a scale||Standard Deviation|Mean
83556|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Internalizing|The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child”, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.|8 years from study entry|||units on a scale||Standard Deviation|Mean
83557|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math|The WJR-III, Ach, Broad Math measures math academic achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Math was selected because its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families. The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry|||units on a scale||Standard Deviation|Mean
83558|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading|The WJR-III, Ach, Broad Reading measures reading achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Broad Reading was selected because it includes indices of reading and a recent standardization sample that includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry|||units on a scale||Standard Deviation|Mean
83559|NCT00970853|Primary|Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)|The WJR-III, Cog measures intelligence and cognition in children and offers a recent standardization sample and updated item content. The WJR-III, Cog was selected because it includes verbal, nonverbal, and language scales and its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years post original enrollment in study|All were included.||units on a scale||Standard Deviation|Mean
83560|NCT00970814|Primary|The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Study Weeks 5-14|||percentage of heavy drinking days||Standard Error|Least Squares Mean
83561|NCT00970814|Secondary|The Number of Drinks Per Drinking Day Study Weeks 5-14.|based on self report|Study Weeks 5-14|||drinks per day||Standard Error|Least Squares Mean
83562|NCT00970814|Primary|The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Weeks 5-14|||percentage of subjects|||Number
83563|NCT00970736|Secondary|Area of Submental Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation.|2 weeks|This data was not analyzed because the study, funding, and PIs VA affiliation ended prior to any data analyses.|||||
83564|NCT00970736|Secondary|Motor Map Center of Gravity|Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).|2 weeks|This data was not analyzed because the study and funding, as well as the PIs VA affiliation, ended prior to doing any analyses.|||||
83565|NCT00970736|Primary|Mean Motor Evoked Potential Amplitude for Submental Cortical Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.|2 weeks|This data was not analyzed because the study funding, as well as PIs VA affiliation, ended prior to any data analyses.|||||
83566|NCT00970684|Secondary|Best Response|The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)|1 year|One patient was unevaluable for response due to missing baseline tumor measurement.||participants|||Number
83567|NCT00970684|Secondary|Median Time to Progression|Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.|1 year|Intent to treat||months||95% Confidence Interval|Median
83568|NCT00970684|Primary|Progression Free Survival(PFS)|PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.|1 year|Intent to treat||months||95% Confidence Interval|Median
83569|NCT00970632|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|PVR was the amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliter (mL)||Standard Deviation|Median
83570|NCT00970632|Secondary|Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks|V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliter (mL)||Standard Deviation|Median
83571|NCT00970632|Secondary|Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks|Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was >=125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliters per second (mL/sec)||Standard Deviation|Median
83572|NCT00970632|Secondary|Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks|Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).||milliliters per second (mL/sec)||Standard Deviation|Median
83573|NCT00970632|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks|IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all randomized sexually active participants with erectile dysfunction who started study medication, and had baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83574|NCT00970632|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline measurement.||units on a scale||Standard Deviation|Median
83575|NCT00970632|Secondary|Clinician Global Impression of Improvement (CGI-I) at 12 Weeks|"The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant’s symptoms based on a 7-point scale. A score of 1=participant felt symptoms were “very much better”; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt “no change” in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were “very much worse”."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.||participants|||Number
83576|NCT00970632|Secondary|Patient Global Impression of Improvement (PGI-I) at 12 Weeks|"The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant’s symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were “very much better”; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt “no change” in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were “very much worse”."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.||participants|||Number
83577|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83578|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83579|NCT00970632|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week|The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 1 week|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83580|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks|IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83581|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks|The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83582|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.|IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83583|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks|IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83584|NCT00970632|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83585|NCT00970632|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
83586|NCT00970606|Primary|Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation).|No outcome analyses were run as the sample size was not of sufficient size for a comparison with only 7 of >2000 participants planned/anticipated actually enrolled.|28 days|Only 7 participants were enrolled in this study designed for >2000. No formal anlaysis of outcomes was performed as tne n was too small to show any differences|||||
83587|NCT00970320|Secondary|Change in Manometry Measurements|manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction|12 to 24 months postpartum||||||
83588|NCT00970320|Secondary|Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale|Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).|12 to 24 months postpartum||||||
88707|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
83589|NCT00970320|Secondary|Fecal Incontinence of Life (FIQL) Scale|Change in health-related quality of Life as measured on the fecal incontinence quality of life scale (FIQL). There is no total scale, only four sub scales ranging from 4 (complete continence, no impact on QoL) to 1 (complete incontinence, severe impact on QoL) Data from the postpartum period has not and will not be analysed due to low numbers.|0 to 24 months postpartum||||||
83590|NCT00970320|Secondary|Change in Urinary Incontinence as Measured on ICI-Q UI SF|"International Consultation of Incontinence Questionnaire, short form (ICI-Q SF) ranges from 0 (Complete continence) to 21 (Complete incontinence) and measures the frequency of UI, amount of leakage and impact on quality of life.~Data have not been analysed."|0 to 24 months postpartum||||||
83591|NCT00970320|Primary|Change in Anal Incontinence as Measured on the St. Mark's Score|Survey and interview using the questionnaire St. Mark's incontinence score ranging from 0 (no incontinence) -24 (complete incontinence) points for measuring anal incontinence (AI). The A total of 1069 women responded to the questionnaires at 6 months postpartum and 1031 at 12 months postpartum. Discrepancies in the number of included and analysed participants in the PFME trials are related to the number of women who did not attend the follow-up appointments as described in the published paper.|0 to 24 months postpartum|||units on a scale||Standard Deviation|Mean
83592|NCT00970294|Secondary|Glycemic Control|HbA1c measure|Baseline and at 10 weeks (change score)|||percentage of glycosolated hemoglobin||Standard Deviation|Mean
83593|NCT00970294|Secondary|Aerobic Fitness|peak VO2 as measured with a graded maximal exercise test on a cycle ergometer|Baseline and at 10 weeks (change score)|||mL/kg/m||Standard Deviation|Mean
83594|NCT00970294|Primary|Recruitment, Retention, Adherence|% of enrolled subjects who completed the trial|10 weeks|||percentage of participants|||Number
83595|NCT00970281|Secondary|Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection|Assesses extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms; 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). Total points of 8 items are defined as DIEPSS total (0 to 32 points). Items for assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by points given to corresponding items (item 6, item 7, and item 8, respectively).|Up to 24 hours after the first IM injection|Participants with an abnormal value at post-baseline, last observation carried forward (LOCF).||percentage of participants|||Number
83596|NCT00970281|Secondary|Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|up to 24 hours after the first IM injection|Participants having a post-baseline measure, last observation carried forward (LOCF).||percentage of participants|||Number
83597|NCT00970281|Secondary|Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Up to 2 hours after the first (IM) injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).||percentage of participants|||Number
83598|NCT00970281|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 24 hours after first IM injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
83599|NCT00970281|Secondary|Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
83600|NCT00970281|Primary|Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 2 hours after first IM injection|Participants with a baseline and a value at the time, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
83601|NCT00970268|Secondary|Change From Baseline in Peak FEV1|Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).|52 weeks|||L||Standard Error|Least Squares Mean
83630|NCT00969228|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (2-3 months).|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
83602|NCT00970268|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1|Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks|From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population||L||Standard Error|Least Squares Mean
83603|NCT00970216|Primary|HBV-DNA < 300 Copies/mL in 48 Weeks||48 weeks|||participants|||Number
83604|NCT00969878|Secondary|•The Immunogenicity of TA-CD;|Peak antibody levels after five vaccinations with TA-CD, which occurred at week 16.|During the 18 weeks study period.|||micrograms/ml||95% Confidence Interval|Mean
83605|NCT00969878|Primary|Cocaine Abstinence During Weeks 9 to 16 Inclusive|Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo|Over 8 weeks ( Study Weeks 9 to 16 inclusive)|||participants|||Number
83606|NCT00969709|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate functional impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe for all measured symptoms)|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment(Intent to Treat [ITT] Population).||units on a scale||Standard Error|Mean
83607|NCT00969709|Primary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|"The MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity for all measured symptoms)."|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment (Intent to Treat [ITT] Population).||Units on a scale||Standard Error|Least Squares Mean
83608|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items|The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMD-17 measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
83609|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A Informant scores measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
83610|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the overall severity of the participant’s ADHD symptoms in relation to the clinician’s total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CGI-ADHD-S measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
83611|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items|The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMA-14 measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
83631|NCT00969228|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 – Day 30) follow-up period after each vaccine dose|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
87401|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after third treatment|Safety population||cm||Full Range|Mean
83612|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A self report measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
83613|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores|AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline AAQoL measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
83614|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)|CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CAARS measurement. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Deviation|Mean
83615|NCT00969618|Primary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through 48 weeks|All participants who received at least one dose of study drug.||participant|||Number
83616|NCT00969540|Secondary|Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Minutes||Standard Deviation|Mean
83617|NCT00969540|Secondary|Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Percentage of time asleep||Standard Deviation|Mean
83618|NCT00969540|Secondary|Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Awakenings||Standard Deviation|Mean
83619|NCT00969540|Secondary|Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Minutes||Standard Deviation|Mean
83620|NCT00969540|Secondary|Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.||Minutes||Standard Deviation|Mean
83621|NCT00969540|Primary|Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).|"The primary outcomes are the change in mean daily Clinical Global Impressions (pain and sleep) in placebo mattress compared to active mattress cover (assessed daily for 14 days per intervention).~The daily scores range from 1 (very much improved) to 7 (very much worse)."|14 days|The sponsor determined the size of the study.||units on a scale||Standard Deviation|Mean
83622|NCT00969501|Primary|Number of Participants With a Reduction in Pain by the Scores.|Greater than 50 percent reduction in pain scores from baseline.|6 months|￼||participants|||Number
83623|NCT00969280|Secondary|General Assessment||visit 11||||||
83624|NCT00969280|Secondary|Medication Quantification Scale (MQS)||every visit||||||
83625|NCT00969280|Secondary|Tear Film Break-up Time : BUT||Visit 1, 10||||||
83626|NCT00969280|Secondary|Schirmer 1 Test||visit 1,10||||||
83627|NCT00969280|Secondary|Visual Analogue Scale of Self Symptoms||every visit||||||
83628|NCT00969280|Primary|Ocular Surface Disease Index : OSDI|The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals “none of the time” and 4 equals “all of the time”. OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.|Visit 11 (after 3 weeks from baseline)|Statistical analyses were conducted on an intention-to-treat basis (ITT analysis, significance p<0.05). According to the last observation carried forward method (LOCF method), the last observed missing values were used to complete missing values from drop-out participants.||Scores on the OSDI score|Participants|Standard Deviation|Mean
83629|NCT00969228|Secondary|Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)||From Dose 1 up to 1 month after Dose 2.|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
83632|NCT00969228|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.|During the 8-day (Day 0 – Day 7) follow-up period after each vaccine dose.|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
83633|NCT00969228|Secondary|Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
83634|NCT00969228|Primary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A|Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
83635|NCT00969150|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|||units on a scale||Standard Error|Least Squares Mean
83636|NCT00969150|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|Of the 357 patients who received at least 1 dose of double-blind treatment (Safety Population), 355 patients had at least 1 postbaseline MADRS assessment (Intent to Treat [ITT] Population).||units on a scale||Standard Error|Least Squares Mean
83637|NCT00968981|Primary|Time to Achieve Maximum Observed Plasma Concentration (Tmax) After a Single Dose of GDC-0449||0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1|PK Evaluable Population.||hours||Full Range|Median
83638|NCT00968981|Secondary|Duration of Response (DR)|DR during first line therapy is defined as the time from when response (complete response [CR] or partial response [PR]) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. CR: disappearance of all target lesions (TLs) with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters. PR: at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum diameters. DR was not calculated as only 1 responding participant reached their response at the last scheduled response assessment, hence follow-up data are not available.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks||||||
83639|NCT00968981|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) for Total and Unbound GDC-0449|AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). BLQ values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified time point in each group.||mcM*hour||Standard Deviation|Mean
83640|NCT00968981|Primary|Area Under the Curve From Time Zero to 24 Hour (AUC0-24) for Total and Unbound GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). Below the limit of quantitation (BLQ) values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified timepoint in each group.||mcM*hour||Standard Deviation|Mean
83641|NCT00968981|Primary|Maximum Plasma Concentration (Cmax) of Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.|0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1, 15 and 57 post-dose|PK Evaluable Population. 'n' signifies number of participants with data available at specified timepoint in each group.||mcM||Standard Deviation|Mean
83642|NCT00968981|Primary|Plasma Concentration at Steady State (Css) for Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. N = participants with baseline and post baseline data available for measurement of Css at steady state.||mcM||Standard Deviation|Mean
83643|NCT00968981|Primary|Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15|Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. N = participants who completed Day 57 of the study were included in this analysis.||ratio||Full Range|Mean
83670|NCT00968799|Primary|Fitness for Systemic Chemotherapy|"Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial.~If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit.~If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit."|3 months post operation|||participants|||Number
83644|NCT00968981|Primary|Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)|Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. Here number of participants analyzed (N) = participants with baseline and at least 1 post baseline assessment for this outcome.||participants|||Number
83645|NCT00968981|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449||Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. Number of participants analyzed (N) is equal to (=) participants with baseline and at least one post-baseline assessment for this outcome; n = participants evaluable at specified time-points.||hours||Full Range|Median
83646|NCT00968981|Secondary|Progression-Free Survival (PFS) Time|PFS defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by the investigator review of tumor assessments using RECIST, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population.||months||95% Confidence Interval|Median
83647|NCT00968981|Secondary|Percentage of Participants With a Response by Best Overall Response (BOR)|BOR was defined as the best overall response observed during the treatment period according to RECIST. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population; only participants with measurable disease at baseline were included in the analysis.||percentage of participants|||Number
83648|NCT00968981|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression (assessed by Response Evaluation Criteria in Solid Tumors [RECIST]) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing non target lesions.|Screening, Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population: all participants who had measurable disease at baseline and either had at least one follow-up tumor assessment or discontinued the study due to disease progression.||percentage of participants|||Number
83649|NCT00968890|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
83650|NCT00968890|Secondary|Number of Subjects With Adverse Events of Specific Interest|Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
83651|NCT00968890|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|From Day 0 to Day 83|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
83652|NCT00968890|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).|Within 7 days (Day 0-Day 6) after each vaccination|Analysis was performed on the Total Vaccinated cohort.||subjects|||Number
83653|NCT00968890|Secondary|Number of Subjects With Titers Equal to or Above Titer 1:10|"The cut-off 1:10 was considered as seropositivity.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
83654|NCT00968890|Primary|Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix|"The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||ratio||95% Confidence Interval|Geometric Mean
83655|NCT00968890|Primary|Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
83696|NCT00968617|Secondary|Hemoglobin Concentration After Treatment With MK2578||Weeks 1-10 and Week 12|||g/dL||Standard Deviation|Mean
83656|NCT00968890|Secondary|Geometric Mean Fold Rise (GMFR)|The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||ratio||95% Confidence Interval|Geometric Mean
83657|NCT00968890|Secondary|Number of Seroprotected Subjects|A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
83658|NCT00968890|Secondary|Number of Seroconverted Subjects|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
83659|NCT00968890|Secondary|Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains|"Titers are expressed as GMTs.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
83660|NCT00968890|Primary|Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.||subjects|||Number
83661|NCT00968838|Primary|Number of Participants Alive at Day 30|Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).|30 Days|||Participants|||Number
83662|NCT00968812|Secondary|Change in HbA1c From Baseline to Week 104|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Baseline, Week 104|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug).||Percent||Standard Error|Least Squares Mean
83663|NCT00968812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent change||Standard Error|Least Squares Mean
83664|NCT00968812|Secondary|Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52|The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
83665|NCT00968812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.||Percent||Standard Error|Least Squares Mean
83666|NCT00968799|Secondary|Pharmacokinetics|data not analysed due to poor accrual|intraoperative and 1 week after surgery||||||
83667|NCT00968799|Secondary|Overall Survival||5 years|||months||Full Range|Median
83668|NCT00968799|Secondary|Surgical Complications|any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)|6 weeks post operation|||participants|||Number
83669|NCT00968799|Secondary|Nephrotoxicity|glomerular filtration rate (GFR)|6 weeks post operation|||participants|||Number
83697|NCT00968617|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||16 Weeks|||Participants|||Number
83698|NCT00968617|Primary|Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia||16 Weeks|||Participants|||Number
83671|NCT00968708|Secondary|Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)|Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.|From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).|Full analysis set||percentage of participants|||Number
83672|NCT00968708|Primary|Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)|Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.|From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).|Full analysis set (all randomized participants)||percentage of participants|||Number
83673|NCT00968669|Secondary|Accumulation Ratio of Trough Concentrations of MEDI-528|Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81) and received at least one dose of investigational product.||Ratio||Standard Deviation|Mean
83674|NCT00968669|Secondary|Half Life of MEDI-528|Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).||Days||Standard Deviation|Mean
83675|NCT00968669|Secondary|Day 169 Steady State Trough Concentration of MEDI-528|Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169.|Day 169|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).||Microgram per milliliter||Standard Deviation|Mean
83676|NCT00968669|Secondary|First Dose Trough Concentration of MEDI-528|First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose.|Day 15|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).||Microgram per milliliter||Standard Deviation|Mean
83677|NCT00968669|Secondary|Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528|Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo|Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo (n=82) group and received at least one dose of investigational product.||Participants|||Number
83678|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 176 (n=62, 58, 64, and 60 for placebo, 30, 100, and 300 mg MEDI-528, respectively).||Participants|||Number
83679|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 85|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 85 (n=69, 63, 76, and 68 for placebo, 30, 100, and 300 mg MEDI-528, respectively).||Participants|||Number
83680|NCT00968669|Secondary|Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176|Day 176|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 176 (n=67, 75, or 73 for 30, 100, or 300 mg MEDI-528, respectively, and n=69 for placebo).||Liters||Standard Deviation|Mean
83681|NCT00968669|Secondary|Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 92 (n=62, 73, or 72 for 30, 100, or 300 mg MEDI-528, respectively, and n=67 for placebo).||Liters||Standard Deviation|Mean
83699|NCT00968617|Primary|Number of of Participants With Composite Events of Injection Site Reactions||16 Weeks|||Participants|||Number
83700|NCT00968617|Primary|Number of Participants With Composite Events of Transfusion-related Adverse Experiences||16 Weeks|||Participants|||Number
83682|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 176.||Day||95% Confidence Interval|Median
83683|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 92.||Day||95% Confidence Interval|Median
83684|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.||Participants|||Number
83685|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 92.||Participants|||Number
83686|NCT00968669|Secondary|Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)|Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.||Scores on a scale||Standard Deviation|Mean
83687|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Day||95% Confidence Interval|Median
88708|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
83688|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Day||95% Confidence Interval|Median
83689|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Participants|||Number
83690|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Participants|||Number
83691|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Exacerbations per participant year||95% Confidence Interval|Number
83692|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)||Exacerbations per participant year||95% Confidence Interval|Number
83693|NCT00968669|Primary|Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)|Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups.||Scores on a scale||Standard Deviation|Mean
83694|NCT00968617|Secondary|Number of Participants Who Were Responders|Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.|Each week up to 12 weeks|||Participants|||Number
83695|NCT00968617|Secondary|Change From Baseline in Hemoglobin Level||Weeks 1-3, 5-10, and Week 12|||g/dL||Standard Deviation|Mean
83703|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension|Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83704|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious LAEs - Extension|Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83705|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension|Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83706|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Extension|Patients who were discontinued due to LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83707|NCT00968201|Secondary|Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients who reported serious drug-related LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83708|NCT00968201|Secondary|Number of Patients With Serious LAEs - Extension|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
83709|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83710|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83711|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension|Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83712|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Extension|Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83713|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension|Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83714|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Extension|Patients who were discontinued due to CAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83715|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension|"Patients who reported serious drug-related CAEs up to 2.8 years of~treatment"|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83716|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Extension|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83717|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83718|NCT00968201|Secondary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.||Participants|||Number
83719|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study|Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83720|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Base Study|Patients who were discontinued due to LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83721|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83761|NCT00967668|Secondary|Change in Weight|Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.|24 months after enrollment|Includes only individuals who formally consented to participate in the second 12 months of the study.||kilograms||95% Confidence Interval|Mean
83722|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83723|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study|Patients who were discontinued due to serious CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
83724|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study|Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
83725|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Base Study|Patients who were discontinued due to CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
83726|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study|Patients who reported serious drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
83727|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Base Study|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks of treatment|"All patients who took study medication were included in the analysis.~A serious CAE (study drug overdose) prior to randomization in the Placebo group is not included in this number"||Participants|||Number
83728|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|12 weeks of treatment|"All patients who took study medication were included in the analysis.~Drug relationship for 1 patient in the Placebo group should have been listed as definitely not drug related."||Participants|||Number
83729|NCT00968201|Primary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
83730|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83731|NCT00968149|Secondary|Number of Patients With Drug-related LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83732|NCT00968149|Secondary|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83733|NCT00968149|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.||Participants|||Number
83734|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to CAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
83735|NCT00968149|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
83736|NCT00968149|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
83737|NCT00968149|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.||Participants|||Number
83738|NCT00968071|Primary|Number of Participants With Complete Response (CR)|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral anc >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.|Up to 36 weeks|||participants|||Number
83739|NCT00968032|Primary|Number of Participants With a Successful Implantation.|The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.|6 weeks ± 2 weeks|||participants|||Number
83740|NCT00968019|Secondary|Stroke||Up to 12 months|||participants|||Number
83743|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:~Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:~ischemic symptoms~ECG changes indicative of ischemia (ST segment elevation or depression)~Development of pathological Q waves in the ECG~Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality~Pathological findings of an acute myocardial infarction"|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
83744|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.~Target vessel failure will be reported when:~MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is performed."|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
83745|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
83746|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)||participants|Participants||Number
83747|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 30 days|||participants|||Number
83748|NCT00968019|Secondary|Stroke||Up to 30 days|||participants|||Number
83749|NCT00968019|Secondary|Major Bleeding||Up to 30 days|||participants|||Number
83750|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:~Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:~ischemic symptoms~ECG changes indicative of ischemia (ST segment elevation or depression)~Development of pathological Q waves in the ECG~Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality~Pathological findings of an acute myocardial infarction"|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
83751|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.~Target vessel failure will be reported when:~MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is performed."|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
83752|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
83753|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)||participants|Participants||Number
83754|NCT00968019|Secondary|Procedural Success|Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)||percentage of Procedural Success|Participants||Number
83755|NCT00968019|Secondary|Lesion Success|Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)||percentage of lesion Success|Participants||Number
83756|NCT00968019|Secondary|Device Success|Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)||percentage of device success|Participants||Number
83757|NCT00968019|Primary|Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))|"Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).~The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%)."|at 12 months follow-up|No formal statistical significance testing was performed. Descriptive statistics were calculated for all relevant variables (mean, standard deviation, median and ranges for the continuous variables and with frequencies and % for the discrete variables). Subjects who discontinued prematurely were included in the analysis and were not replaced.||participants|||Number
83758|NCT00967993|Secondary|The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.||6 weeks||||||
83759|NCT00967993|Primary|The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.||4 weeks|||mg/dL||Standard Deviation|Mean
83765|NCT00967486|Primary|Overall Perioperative Complications Between Selective vs. Routine Shunting.|perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.|Within 30 days of enrollment|||Participants|||Number
83766|NCT00967473|Primary|Lens Axis Misalignment|Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.|Time of surgery|All implanted subjects were included in this analysis.||Degrees||Full Range|Mean
83767|NCT00967473|Primary|Reduction of Cylinder|Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.|6 months after surgery on second eye|All implanted subjects were included in this analysis.||Percent reduction of cylinder||95% Confidence Interval|Mean
83768|NCT00967473|Primary|Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment|Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects’ experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.|Before Surgery and 180 days after second eye implant|Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention.||Participants|||Number
83769|NCT00967447|Secondary|Volume of Wound Drainage||From 12 To 37 Days|The trial was stopped due poor enrollment|||||
83770|NCT00967447|Secondary|Major Extra Surgical Site Bleedings||From 12 To 37 Days|The trial was stopped due poor enrollment|||||
83771|NCT00967447|Secondary|Major Bleeding Events (MBE)||From 12 To 37 Days|The trial was stopped due poor enrollment|||||
83772|NCT00967447|Primary|Venous Thromboembolic Events||6 Months|The trial was stopped due poor enrollment|||||
83773|NCT00967330|Secondary|Time to Treatment Failure||From baseline until end of study (up to 4.5 years)|Data for this outcome measure were not collected as this outcome was removed as per changes in planned analysis.||years||Full Range|Median
83774|NCT00967330|Secondary|Percentage of Participants Who Received Corticosteroid for Glioblastoma|Participants used corticosteroids for the glioblastoma condition. Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone.|From baseline to Month 6|The safety population (SAF) was defined to include all participants who received at least 1 dose of study medication. Data were analyzed according to the treatment actually received (as treated).||percentage of participants|||Number
83775|NCT00967330|Secondary|Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30)|KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score.|Baseline, Post-Baseline (up to Month 30)|ITT population||units on a scale||95% Confidence Interval|Least Squares Mean
83776|NCT00967330|Secondary|Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30)|The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function.|Baseline, Post-Baseline (up to Month 30)|ITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
83777|NCT00967330|Secondary|Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30)|EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Baseline, Post-Baseline (up to Month 30)|ITT population||units on a scale||95% Confidence Interval|Least Squares Mean
83778|NCT00967330|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30)|The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 ‘Not at all’ to 4 ‘Very much’; 2 questions used 7-point scale (1 ‘very poor’ to 7 ‘Excellent’). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ‘’baseline’’ refers to the time of randomization to the maintenance phase.|Baseline, Post-Baseline (up to Month 30)|ITT population.||units on a scale||95% Confidence Interval|Least Squares Mean
83779|NCT00967330|Secondary|Percentage of Participants With Response on FLAIR Imaging|"FLAIR lesions were determined as “stable”, “progressive” or “decreased”. FLAIR lesions was determined as “progressive” only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population.~Dis.=Discontinuation."|At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)|ITT population. Here, n = participants with at least 1 assessment during specified time-point.||percentage of participants|||Number
83797|NCT00967226|Primary|Decrease in Size of Hemangioma (Length x Width) in Square mm|A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available.|4-5 months after initiating therapy|Data available at 4 or 5 months for only 9/11 propranolol participants and for 6/8 prednisolone participants due to missed appointments. Overall, 90% (138/154) study appointments were completed.||mm squared||95% Confidence Interval|Mean
83780|NCT00967330|Secondary|Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR)|BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved.|4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6|ITT population. Data were analyzed according to the treatment randomized (as randomized). Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable of specified time-point.||participants|||Number
83781|NCT00967330|Secondary|Percentage of Participants Who Discontinued|Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones.|From baseline until death (up to 4.5 years)|ITT population||percentage of participants|||Number
83782|NCT00967330|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method.|From baseline until death (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).||Months||95% Confidence Interval|Median
83783|NCT00967330|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method.|From baseline to the end of the study (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).||Months||95% Confidence Interval|Median
83784|NCT00967330|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported.|6 months|Intent-to-treat (ITT) population included participants randomized for whom it cannot be ruled out, that they took study medication at least once and where primary variable was measured at least once under study medication. Data were analyzed according to the treatment randomized (as randomized).||percentage of participants||95% Confidence Interval|Number
83785|NCT00967226|Secondary|Constitutional Adverse Events|Number of constitutional AEs in each study arm.|enrollment to study close out or withdrawal up to 9 months|||Adverse Events|||Number
83786|NCT00967226|Secondary|Vascular Adverse Events|Number of Vascular AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
83787|NCT00967226|Secondary|Metabolic or Laboratory AEs|Number of Metabolic or Laboratory AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
83788|NCT00967226|Secondary|Infectious Adverse Events|Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever)|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
83789|NCT00967226|Secondary|Gastrointestinal Adverse Events|Number of Gastrointestinal AEs in each arm|enrollment to study withdrawal or study close out up to 9 months|||Adverse Events|||Number
83790|NCT00967226|Secondary|Endocrinologic Adverse Events|Number of Endocrinologic AEs (of which adrenal crisis does not overlap).|enrollment to close out or study withdrawal up to 9 months|||Adverse Events|||Number
83791|NCT00967226|Secondary|Dermatologic Adverse Events|Number of Dermatologic Adverse Events in each study arm.|enrollment to study close out or withdrawal up to 9 months|||Adverse Events|||Number
83792|NCT00967226|Secondary|Allergy/Immunology Adverse Events|Number of allergy/immunology AE per study arm|enrollment through study closeout or study withdrawal up to 9 months|||Adverse Events|||Number
83793|NCT00967226|Secondary|Pulmonary/Respiratory Adverse Events|Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm|enrollment through study close out or withdrawal, up to 9 months|||Adverse Events|||Number
83794|NCT00967226|Secondary|Growth and Development Adverse Events|Number of Growth and Development AEs in each study arm|enrollment to study withdrawal or close out up to 9 months|||Adverse Events|||Number
83795|NCT00967226|Secondary|Number of Serious Adverse Events (SAEs)|Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|enrollment until study close out or withdrawal up to 9 months|||Serious Adverse Events|||Number
83796|NCT00967226|Secondary|Tolerability of Medication|All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular.|enrollment until study close out or withdrawal up to 9 months|"All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. In this table Adverse Events are those exclusive of the Serious Adverse Events which are noted separately."||Events|||Number
83863|NCT00966238|Secondary|Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers||28 days after vaccination|The immunogenicity of the vaccine was evaluated by measuring the number of subjects who demonstrate seroconversion either by developing a measurable titer following vaccination or by showing a significant increase in HAI serum antibody titers post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
83798|NCT00967044|Primary|Maximum Tolerated Dose (MTD) of Everolimus With Panobinostat|MTD of the novel combination of Everolimus + Panobinostat (LBH589) in a phase-I study in participants with relapsed lymphoma (Hodgkin and non-Hodgkin) where MTD is defined as the highest dose at which no more than 1 in 6 of the participants in the cohort experiences one or more dose limiting toxicities (DLTs) in the first 28 day treatment cycle. Thirty patients were enrolled onto four dose levels: Everolimus (mg, orally) 5, 5, 10, 10 daily or Panobinostat (mg, orally) 10, 20, 20, 30 three times per week. The MTD was established without the use of colony stimulating factor in cycle 1.|28 day treatment cycle|||mg, orally|||Number
83799|NCT00967018|Other Pre-specified|Serum Levels of Testosterone Over Time|Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)|from baseline to week 72|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)||ng/mL||Full Range|Median
83800|NCT00967018|Other Pre-specified|Serum Levels of Prostate Specific Antigen (PSA)Over Time|PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)|from baseline to 72 weeks|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)||ng/mL||Full Range|Median
83801|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Up to 22.5 months|||Participants|||Number
83802|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Up to 22.5 months|||Participants|||Number
83803|NCT00966992|Secondary|Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease||3 months after completion of treatment and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
83804|NCT00966992|Secondary|If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood||At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
83805|NCT00966992|Secondary|Change in Biochemical Markers of Bone Turnover||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
83806|NCT00966992|Secondary|Change in Bone Mineral Density||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
83807|NCT00966992|Primary|Incidence of Disseminated Tumor Cells in Bone Marrow||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
83808|NCT00966992|Primary|Incidence of Circulating Tumor Cells (CTCs)||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.|||||
83809|NCT00966953|Primary|Plaque Index|Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|8 weeks|||Units on a scale||Standard Deviation|Mean
83810|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 6:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
83811|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 4:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
83812|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 2:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
83813|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 12:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
83814|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 10:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
83815|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 8:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
83816|NCT00966940|Primary|Mean Intraocular Pressure (IOP) at 8:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.||mm Hg||Standard Deviation|Mean
83817|NCT00966875|Secondary|Percentage of Participants With Anti-LY2439821 Antibodies|Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.|Week 16, Week 64|Part A (Week 16) FAS: all randomized participants who received at least 1 dose of study drug with antibody testing performed; Part B (Week 64): All participants from Part A who entered the open-label portion of the study, part B, with baseline and at least 1 post-baseline antibody testing.||percentage of participants|||Number
83818|NCT00966875|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State|Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).|Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6|All randomized participants who received at least 1 dose of study drug in Part A and had estimable PK data, as well as, participants from Part A who entered the open-label portion of the study, Part B, and had estimable PK data.||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
83819|NCT00966875|Secondary|Relationship Between Exposure and Response of EULAR28||Through Week 72|Relationship between exposure and response of EULAR 28 analysis was reported in OMs 22 and 23 as percentage of participants in EULAR28 (Parts A and B), respectively. No further analyses were completed for EULAR28.|||||
83820|NCT00966875|Secondary|Relationship Between Exposure and Response of DAS28||Through Week 72|Relationship between exposure and response of DAS28 analysis was reported in OMs 6 and 7 as change from baseline in DAS28 (Parts A and B) respectively. No further analyses were completed for DAS28.|||||
83821|NCT00966875|Secondary|Relationship Between Exposure and Response of ACR20/50/70/N||Through Week 72|Relationship between exposure and response ACR20/50/70/N analysis was reported in OMs 8 and 9, as percentage of participants with ACR 20/50/70 Response (Parts A and B) and OMs 24 and 25 as percentage of participants with ACR-N (Parts A and B) respectively. No further analyses were completed for ACR20/50/70/N.|||||
83822|NCT00966875|Secondary|Relationship Between Exposure and Response of Individual Components of the ACR Core Set||Through Week 72|Relationship between exposure and response in Individual Components (IC) of ACR Core Set analysis was reported in outcome measures (OMs) 10-21 as change from baseline in IC of ACR Core Sets: TJC, SJC, PAAP-VAS, PtGADA-VAS, PhGA-VAS, and CRP (Parts A and B). No further analyses were completed for individual components of ACR Core Set.|||||
83823|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part B|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 HAQ-DI results.||units on a scale||Standard Deviation|Mean
83824|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part A|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||units on a scale||Standard Deviation|Mean
83825|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 Duration of Morning Stiffness results.||minutes||Standard Deviation|Mean
83826|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||minutes||Standard Deviation|Mean
83847|NCT00966875|Secondary|Change From Baseline in DAS28 - Part B|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 DAS28 results.||units on a scale||Standard Deviation|Mean
83827|NCT00966875|Secondary|Change From Baseline in FACIT Fatigue Scale - Part B|The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 FACIT results.||units on a scale||Standard Deviation|Mean
83828|NCT00966875|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A|The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, up to Week 12|Part A FAS: defined as all data from all randomized participants who received at least 1 dose of study drug LOCF.||units on a scale||Standard Deviation|Mean
83829|NCT00966875|Secondary|ACR-N - Part B|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR-N results.||units on a scale||Standard Deviation|Mean
83830|NCT00966875|Secondary|ACR-N - Part A|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug with results at Week 12; LOCF.||units on a scale||Standard Deviation|Mean
83831|NCT00966875|Secondary|Percentage of Participants in EULAR28 - Part B|Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 EULAR28 results.||percentage of participants|||Number
83832|NCT00966875|Secondary|Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A|Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||percentage of participants|||Number
83833|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 CRP results.||mg/L||Standard Deviation|Mean
83834|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mg/L||Standard Deviation|Mean
83835|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B|"The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PhGA-VAS results.||mm||Standard Deviation|Mean
83836|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A|"The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mm||Standard Deviation|Mean
83837|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PtGADA-VAS results.||mm||Standard Deviation|Mean
83838|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mm||Standard Deviation|Mean
83839|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PAAP-VAS results.||mm||Standard Deviation|Mean
83840|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||mm||Standard Deviation|Mean
83841|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 SJC results.||swollen joints||Standard Deviation|Mean
83842|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||swollen joints||Standard Deviation|Mean
83843|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 TJC results.||tender joints||Standard Deviation|Mean
83844|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.||tender joints||Standard Deviation|Mean
83845|NCT00966875|Secondary|Percentage of Participants With of ACR20/50/70 Response - Part B|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR20/50/70 results.||percentage of participants|||Number
83846|NCT00966875|Secondary|Percentage of Participants With ACR20/50/70 Response - Part A|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
83864|NCT00966238|Primary|Number of Participants With Local and Systemic Immediate Reactogenicity Complaints||within 4 hours following vaccination|Immediate complaints were vaccination symptoms that were solicited and observed at 30 minutes (+15 minutes) and (±30 minutes) after the vaccination on Day 0.||Participants|||Number
83848|NCT00966875|Secondary|Change From Baseline in Disease Activity Score (DAS28)-Part A|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
83849|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population|ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||log (dose) mg|||Number
83850|NCT00966875|Secondary|Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population|DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 − CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||log (dose) mg|||Number
83851|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||log (dose) mg|||Number
83852|NCT00966875|Secondary|Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population|ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were TNFα-IR.||percentage of participants|||Number
83853|NCT00966875|Primary|Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient’s Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician’s Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.||percentage of participants|||Number
83854|NCT00966641|Primary|Area Under the Curve of Plasma Naproxen From 0 to t|Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.|30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.|Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations.||min×μg/mL||Full Range|Mean
83855|NCT00966550|Primary|IL-6 Concentrations||6 hour postprandial study|Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing.||pg/mL||Standard Error|Least Squares Mean
83856|NCT00966446|Secondary|Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization|Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.|Within 6 months|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis, as this was necessary to determine clearance of MRSA colonization||days||95% Confidence Interval|Median
83857|NCT00966446|Primary|First Two Consecutive Sampling Periods Completed|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis|Within 2 months|These subjects sent in two consecutive swab samples starting with their first follow-up time point.||participants|||Number
83858|NCT00966446|Primary|Recurrent Infection|Confirmed new MRSA infections|Within 6 months|These study participants who self-reported re-infections of MRSA||participants|||Number
83859|NCT00966277|Primary|Number of Participants With Venous Thromboembolic Events (VTE)|Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.|16 weeks of treatment|||participants|||Number
83860|NCT00966264|Secondary|Depression||baseline, 6 and 12 months, 5 and 10 years||05/2010||||
83861|NCT00966264|Primary|Costs||baseline, 6 and 12 months, 5 and 10 years||05/2010||||
83862|NCT00966264|Primary|HRQoL (Health Related Quality of Life)|HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)|baseline and 5 years|The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups||points on a scale||95% Confidence Interval|Mean
83865|NCT00966186|Secondary|Insertion Time, Sealing Pressure and Complication||5 min - 4 hours||||||
83867|NCT00965848|Secondary|Number of Participants With 90-day Mortality|Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.|up to Day 90|"The cMITT included all participants who received any dose of study medication and met the clinical definition in the protocol. N” signifies those participants who were evaluated for this measure."||Participants|||Number
83868|NCT00965848|Secondary|Percentage of Participants With Clinical Response at Test-of-Cure (TOC)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT).|Up to Day 14 after End-of-Treatment (EOT)|"The cMITT included all participants who received any dose of study medication. “N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of Participants|||Number
83869|NCT00965848|Secondary|Percentage of Participants With Clinical Response at End-of-Treatment (EOT)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up.|Up to Day 14 (EOT)|"Clinical Modified-Intent-to-Treat (cMITT) included all participants who received any dose of study medication. N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of participants|||Number
83870|NCT00965848|Primary|Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs|An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.|Up to 30 days after last dose of study drug|Intent-to-treat population (ITT) included all participants who received at least one dose of study medication.||Participants|||Number
83871|NCT00965757|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)||Percentage of Participants||95% Confidence Interval|Number
83872|NCT00965757|Secondary|Percentage of ACR 70 Criteria Responders|ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||Percentage of Participants||95% Confidence Interval|Number
83873|NCT00965757|Secondary|Percentage of ACR 50 Criteria Responders|ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)||Percentage of Participants||95% Confidence Interval|Number
83874|NCT00965757|Secondary|Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)|The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||participants|||Number
83875|NCT00965757|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Assessment of individual ACR core components i.e. ESR|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||mm/hr||Standard Deviation|Mean
83876|NCT00965757|Secondary|Change From Baseline in C-reactive Protein (CRP)|Assessment of individual ACR core components i.e. CRP|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||mg/dl||Standard Deviation|Mean
83877|NCT00965757|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||score on scale||Standard Deviation|Mean
88709|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
83878|NCT00965757|Secondary|Change From Baseline in PAP, PtGADA and PyGADA|Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0–100 mm, with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||mm||Standard Deviation|Mean
83879|NCT00965757|Secondary|Change From Baseline in Tender Joint Counts and Swollen Joint Counts|Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)||joint counts||Standard Deviation|Mean
83880|NCT00965731|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|If no more than 1/6 participants presented with a DLT during Cycle 1 at the MTD, then this dose level was considered the RP2D. If >1/6 participants experienced a DLT, then the previous lower level was considered the MTD and RP2D.|Baseline up to 28 days (Cycle 1)|DLT evaluable population||mg|||Number
83881|NCT00965731|Other Pre-specified|Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|MTD: the combination dose level of PF-02341066 and erlotinib in which 0/6 or 1/6 participants experienced DLT after 28 days of treatment (Cycle 1) with the next higher dose level having at least 2/3 or 2/6 participants with DLT during Cycle 1 of treatment.|Baseline up to 28 days (Cycle 1)|DLT evaluable population||mg|||Number
83882|NCT00965731|Secondary|Percentage of Participants With Mutations in Tumor Tissue (Phase 2)|Tumor tissue samples collected for molecular profiling were to be analyzed to assess Kirsten rat sarcoma (KRAS) mutations, mutations, amplification and expression of Epidermal Growth Factor Receptor (EGFR) and c-Met, and echinoderm microtubule-associated protein-like 4-anaplastic large cell receptor kinase (EML4-ALK) fusion in tumors.|Screening|Not analyzed due to phase 2 study termination|||||
83883|NCT00965731|Secondary|Plasma Concentration of Erlotinib (Phase 2)|Plasma concentration of erlotinib when administered as a single agent during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose)|Not analyzed due to phase 2 study termination|||||
83884|NCT00965731|Secondary|Plasma Concentration of PF-02341066 and Erlotinib (Phase 2)|Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose|Not analyzed due to phase 2 study termination|||||
83885|NCT00965731|Secondary|EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination|||||
83886|NCT00965731|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2|Phase 2 EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination|||||
83887|NCT00965731|Secondary|Overall Survival (OS) at Phase 2|Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Baseline until death, up to 20 months|Not analyzed due to phase 2 study termination|||||
83888|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 2)|Percentage of participants during phase 2 with objective response based assessment of confirmed CR or confirmed PR according to RECIST (1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination|||||
83889|NCT00965731|Secondary|Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2|Percentage of participants during phase 2 with confirmed CR, confirmed PR or SD according to RECIST 1.1. Also known as Disease Control Rate (DCR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. SD: neither sufficient shrinkage or increase to qualify for PR or PD.|Week 6 and Week 12|Not analyzed due to phase 2 study termination|||||
83901|NCT00965731|Secondary|Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
83890|NCT00965731|Secondary|Duration of Response (Phase 2)|Median duration (50%) of tumor response. DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination|||||
83891|NCT00965731|Secondary|Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination|||||
83892|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination|||||
83893|NCT00965731|Secondary|Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1)||Baseline and Day 50 (Cycle 3, Day 1)|Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability|||||
83894|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1)|Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50.|Baseline and Day 50 (Cycle 3, Day 1)|The soluble biomarker evaluable population was defined as participants from the safety analysis set of phase 1 who had a soluble protein blood sample taken prior to dosing on Cycle 3 Day 1 and 1 soluble biomarker evaluation after dosing on Cycle 3 Day 1.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
83895|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 1)|Percentage of participants during phase 1 with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|Response Evaluable Population: all participants enrolled into the Phase 1 portion of the study who receive at least one dose of study medication (either PF-02341066 or erlotinib) and have an adequate baseline tumor assessment.||percentage of participants||95% Confidence Interval|Number
83896|NCT00965731|Secondary|Duration of Response (Phase 1)|Median duration (50 percent [%]) of tumor response. Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of responses|||||
83897|NCT00965731|Secondary|Progression-Free Survival (Phase 1)|"Time in weeks from phase 1 randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of study participants|||||
83898|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||Ratio in percentage||90% Confidence Interval|Geometric Mean
83899|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The PK parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||Ratio in percentage||90% Confidence Interval|Geometric Mean
83900|NCT00965731|Secondary|Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, it is used to characterize erlotinib CL/F after multiple doses in combination with PF-02341066 (Cycle 1 Day 15).|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
83964|NCT00965094|Secondary|Change in Renal Function (Creatinine Slope)|X(slope)=(1/value of creatinine).|3 months, 5 months, 7 months, 9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).||mg/dl per month||Standard Deviation|Mean
83902|NCT00965731|Secondary|Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
83903|NCT00965731|Secondary|Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1)|Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||Ratio||Geometric Coefficient of Variation|Geometric Mean
83904|NCT00965731|Secondary|PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
83905|NCT00965731|Secondary|PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
83906|NCT00965731|Secondary|PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
83907|NCT00965731|Secondary|PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
83908|NCT00965731|Secondary|PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
83909|NCT00965731|Primary|Progression-Free Survival (Phase 2)|"Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination|||||
83921|NCT00965562|Primary|Comparison of the Change in PMTS Symptom Scores Among Groups|PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on PMTS scale||Standard Deviation|Mean
83910|NCT00965731|Primary|Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)|Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).|Baseline up to Day 28|DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities)||participants|||Number
83911|NCT00965718|Primary|Progressive Disease(PD)|Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||number of participants|||Number
83912|NCT00965718|Primary|Stable Disease(SD)|Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||number of participants|||Number
83913|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)|QLQ-PAN26 consists of questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||units on a scale||Standard Deviation|Mean
83914|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)|QLQ-C30 constitutes a functional scale(physical, role, emotional, cognitive, and social functioning), symptom scores scale(fatigue, nausea/vomiting, pain, dyspnea, constipation, diarrhea, insomnia, appetite loss, financial difficulties), and global QoL scale. With the scores of all scales ranging from 0 to 100, a higher score indicates a better functional scale and a better global QoL scale as well as a worse symptom scores scale.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||units on a scale||Standard Deviation|Mean
83915|NCT00965718|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||weeks||95% Confidence Interval|Median
83916|NCT00965718|Secondary|Overall Survival (OS)|OS was calculated from the date of enrollment until death from any cause. And OS was estimated using Kaplan-Meier methods with 95% confidence intervals (CIs).|Every visit, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||weeks||95% Confidence Interval|Median
83917|NCT00965718|Primary|Disease Control Rate|"Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.~Disease control rate = CR or PR or SD patients / ITT population *100"|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.||percentage of participants||95% Confidence Interval|Number
83918|NCT00965562|Primary|Comparison of the Change in CGI Improvement Scores Among Groups|CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on CGI Improvement scale||Standard Deviation|Mean
83919|NCT00965562|Primary|Comparison of the Change in DRSP Symptom Scores Among Groups|DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on DRSP scale||Standard Deviation|Mean
83920|NCT00965562|Primary|Comparison of the Change in CGI-S Symptom Scores Among Groups|CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on CGI-S scale||Standard Deviation|Mean
83958|NCT00965185|Secondary|Immune Function|12 month change in CD4 T-lymphocytes|Measured at baseline and 1 year|All available data were used; data were not available for one subject who completed the study.||cells per microliter||95% Confidence Interval|Mean
83959|NCT00965185|Secondary|Endothelial Function||Measured at 1 year||||||
83922|NCT00965562|Primary|Comparison of the Change in IDS Symptom Scores Among Groups|IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.||units on IDS scale||Standard Deviation|Mean
83923|NCT00965562|Secondary|Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe).|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.||proportion of participants|||Number
83924|NCT00965562|Secondary|Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)|"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.~IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe)."|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.||proportion of participants|||Number
83925|NCT00965562|Secondary|Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. However, Visit 5 DRSP calendars were missing for an additional 3 subjects in the fluoxetine group and for one subject in each of the calcium and placebo cells.||proportion of participants|||Number
83926|NCT00965562|Secondary|Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)|PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.||proportion of participants|||Number
83927|NCT00965562|Secondary|Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)|IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.||proportion of participants|||Number
83928|NCT00965562|Secondary|Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)|DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.||proportion of participants|||Number
83929|NCT00965523|Secondary|Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.|Every 6 weeks|Full Analysis Set||percentage of subjects|||Number
83930|NCT00965523|Primary|Number of Subjects With Adverse Events.||Every week during treatment and up to 30 days after last dose of study treatment|Safety Analysis Set||Participants|||Number
83931|NCT00965497|Secondary|McGill Quality of Life Scale (MQOL)|McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).|8 weeks|||quality of life||Full Range|Mean
83932|NCT00965497|Primary|Hamilton Depression Scale (HAM-D 17).|Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.|8 weeks|Intention to Treat||depression severity||Standard Deviation|Median
83933|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; number of participants with measurement.||percentage of dyads||95% Confidence Interval|Number
83960|NCT00965185|Secondary|Plaque Progression|12 month percent change in plaque volume|Measured at baseline and 1 year|All available data were used.||Percent change||95% Confidence Interval|Mean
83934|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS||percentage of dyads||95% Confidence Interval|Number
83935|NCT00965484|Secondary|Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; N=number of participants with measurement.||percentage of dyads||95% Confidence Interval|Number
83936|NCT00965484|Primary|Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|Full analysis set (FAS): all participants who used the new pen at least once to administer Genotropin and who completed the 2-month follow-up questionnaire. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).||percentage of dyads||95% Confidence Interval|Number
83937|NCT00965458|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c level of 5.6% or less is considered normal. HbA1c levels of 6.5% or higher is typical for individuals with Type 1 Diabetes Mellitus (T1DM). The closer HbA1c levels are to normal, the better controlled the disease is.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||HgbA1c percent (%)||Standard Deviation|Mean
83938|NCT00965458|Secondary|Major Hypoglycemic Events Occurring From Randomization|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline to Week 52 and Week 52 to Week 104|Intent-to-treat||Major Hypoglycemic Events|||Number
83939|NCT00965458|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||Units per day divided by weight in kg||Standard Deviation|Mean
83940|NCT00965458|Secondary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||pmol/mL||Standard Deviation|Mean
83941|NCT00965458|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat||pmol/mL||Standard Deviation|Mean
83961|NCT00965185|Primary|Coronary and Aortic Plaque Inflammation|12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)|Measured at baseline and 1 year|All participants with baseline and 12 month PET and CT scans of acceptable image quality to permit assessment of change over time in identical regions in serial scans. As a result, only a limited number of participants could be included.||ratio||95% Confidence Interval|Mean
83962|NCT00965146|Primary|Evaluate Complication Rate.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years||||||
83963|NCT00965146|Primary|Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years||||||
83942|NCT00965458|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (pre-treatment initiation), Week 52|Intent-to-treat||pmol/mL||Standard Deviation|Mean
83943|NCT00965341|Secondary|The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).|The ESAS assessed 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0–10 (0 = no symptom, 10 = worst possible severity). Depression was assessed using the 14-item HADS questionnaire. Each item on the questionnaire was scored from 0-3. Total Scores for the HADS Questionnaire range from 0 to 42 with higher scores denoting feeling of depression.|Day 29 (+/- 3 days)|||units on a scale||Standard Deviation|Mean
83944|NCT00965341|Primary|Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)|The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0–4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement.|Day 29 (+/- 3 days)|||units on a scale||Standard Deviation|Mean
83945|NCT00965250|Secondary|Correlate Response to Therapy With Changes in FDG-PET Imaging|Participants with scans that showed neither sufficient shrinkage to qualify as an objective response nor sufficient increase to qualify as disease progression, taking as reference the smallest cumulative longest dimension since start of treatment, to have stable disease.|6 weeks after initiation of treatment|We did radiological assessment ourselves, and an independent radiological assessment was not undertaken for assessment of response or progression.|||||
83946|NCT00965250|Secondary|Median Number of Cycles of Therapy|A cycle is defined as 21 days or 6 weeks of therapy.|6 weeks|||Cycles||Full Range|Median
83947|NCT00965250|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|39 months|||Months||95% Confidence Interval|Median
83948|NCT00965250|Secondary|Time to Progression|Time between the first day of treatment to the day of disease progression.|39 months|||Months||95% Confidence Interval|Median
83949|NCT00965250|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as objective response plus stable disease.|39 months|||percentage of participants||95% Confidence Interval|Number
83950|NCT00965250|Secondary|Percentage of Participants Who Respond to Treatment|Percentage of participants who respond to treatment was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|39 months|||percentage of participants||95% Confidence Interval|Number
83951|NCT00965250|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|81 months and 17 days|Adverse events are not separated by group because the adverse events are related to the drug which was the same in both groups.||Participants|||Number
83952|NCT00965250|Primary|Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma.|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Patients were assessed for response every 2 cycles (every 6 weeks) while receiving the study drug.|||Participants|||Number
83953|NCT00965237|Primary|Overall Satisfaction With the Lenses|Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.|1 week of wear|Analysis conducted per protocol||Units on a Scale||Standard Deviation|Mean
83954|NCT00965185|Secondary|Liver Function Tests (LFTs)|"Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).~For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.~ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L"|Measured at baseline, 1, 3, 6, 9, and 12 months|All available data were used.||participants|||Number
83955|NCT00965185|Secondary|Adipocytokines||Measured at 1 year||||||
83956|NCT00965185|Secondary|C-reactive Protein (CRP)|12 month change in Log CRP concentration|Measured at baseline and 1 year|All available data were used.||log(mg/L)||95% Confidence Interval|Mean
83957|NCT00965185|Secondary|Lipid Profile|12 month change in lipid profile|Measured at baseline and 1 year|All available data were used.||mmol/L||95% Confidence Interval|Mean
83965|NCT00965094|Secondary|Participants Who Had Occurrence of Treatment Failure.|Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity or conversion to another regimen.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method)||Participants|||Number
83966|NCT00965094|Secondary|Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death.|Biopsy-proven acute rejection was defined as a biopsy gradeed IA, IB, IIA, IIB, or III. The allograft was presumed to be lost if the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable||Participants|||Number
83967|NCT00965094|Secondary|Assessment of GFR by the Cockcroft-Gault Method (LOCF)|the GFR was also calculated using the Cockcroft-Gault method (Cockcroft and Gault 1976) and the Modification of Diet in Renal Disease (MDRD) method (Levey et al., 1999, Rodrigo et al., 2003; Pierrat et al., 2003).Cockcroft-Gault formula For men: GFR= (140-Age)X Body Weight[kg]/72X Serum Creatinine[mg/dl] For women: GFR= 0,85x(140-Age) x Body Weight[kg]/72x Serum Creatinine [mg/dl] The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable||mL/min||Standard Deviation|Mean
83968|NCT00965094|Primary|Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF)|The glomerular filtration rate (GFR) is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. The GFR, calculated according to the Nankivell formula, was used as the primary outcome measure in this study. This equation has been validated in renal transplant patients against the true GFR measured by a radionuclide method and has been confirmed as a very accurate method to calculate the GFR in this specific population (Gaspari et al., 2004)GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C Scr = serum creatinine concentration expressed in mmol/L. BW = body weight in kg, Surea = serum urea in mmol/L and Height is expressed in meters.The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).||mL/min/1.73m^2||Standard Deviation|Mean
83969|NCT00965081|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.~Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.~Suicidal ideation: a “yes” answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation."|Baseline through 12 weeks|Only participants having at least 1 post-baseline C-SSRS assessment were included in this analysis.||Participants|||Number
83970|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)|SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint.||Units on a scale||Standard Error|Least Squares Mean
83971|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)|"The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.~The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline."|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
83972|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per randomly assigned groups. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy(DB) due to adverse event; last non-missing observation during initial DB used to impute the missing endpoint for all others.||Units on a scale||Standard Error|Least Squares Mean
83994|NCT00964548|Secondary|Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Peak Systolic Velocity of vessel in vasospasm (Change from baseline peak systolic velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion|||cm/s||95% Confidence Interval|Mean
83995|NCT00964548|Primary|Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion|||mmHg||95% Confidence Interval|Mean
83973|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
83974|NCT00965081|Secondary|Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint|"The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).~The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
83975|NCT00965081|Secondary|Patient Global Impression - Improvement (PGI-I) at Endpoint|"The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is very much better, 4 is no change, and 7 is very much worse. Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
83976|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form|BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The LOCF method was used to impute the missing endpoint during initial double-blind therapy.||Units on a scale||Standard Error|Least Squares Mean
83977|NCT00965081|Primary|"Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.|Baseline, 12 weeks|Intent-to-treat (ITT) population: all randomized participants. ITT treatment group is group to which participant was randomized regardless of treatment actually received. BOCF method used to impute endpoint value if initial DBT discontinued due to AE. Change from baseline analyses included all those with baseline and ≤1 post-baseline observation.||Units on a scale||Standard Error|Least Squares Mean
83978|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive cognitive behavioral therapy or to no cognitive behavioral therapy (behavioral effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores||Units on a scale.||Standard Error|Mean
83979|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to cognitive behavioral therapy to or no behavior therapy comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.||units on a scale||Standard Error|Mean
83980|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive desipramine hydrochloride or benztropine mesylate (drug effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores||Units on a scale.||Standard Error|Mean
88710|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||μU/μL||Standard Deviation|Mean
83981|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to desipramine or to active drug placebo (benztropine) comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.||units on a scale||Standard Error|Mean
83982|NCT00964860|Secondary|Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|"Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).~Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.~The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites)."|30 days|per protocol||units on a scale||Standard Error|Least Squares Mean
83983|NCT00964860|Primary|Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation|30 days|per protocol||units on a scale||Standard Error|Mean
83984|NCT00964795|Other Pre-specified|Summary of Study Duration (Weeks)|Study Duration = (last visit/ discontinuation date - first dose date + 28)/7|Baseline through end of treatment (Week 180)|||weeks||Standard Deviation|Mean
83985|NCT00964795|Other Pre-specified|Summary of Treatment Duration (Weeks)|Treatment Duration = (last dose date - first dose date + 28)/7|Baseline through end of treatment (Week 180)|||weeks||Standard Deviation|Mean
83986|NCT00964795|Secondary|Change in BCVA Letter Score (mLOCF)|"The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.~(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward)."|Baseline through Week 116|||letters correctly read||Standard Deviation|Mean
83987|NCT00964795|Primary|Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD|"The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).~Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs"|Baseline (day 1) through end of treatment (Week 180)|||participants|||Number
83988|NCT00964743|Secondary|CSF and Serum Vascular Endothelial Growth Factor (VEGF) Levels|CSF and serum VEGF levels were to be measured over time, and the means and standard errors of the respective VEGF levels were to be plotted at specific sampling time points. The respective VEGF levels may also have been correlated with patients’ PFS, OS, or cytology using descriptive statistical methods similarly as mentioned above. The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
83989|NCT00964743|Secondary|Sorafenib Levels in Cerebrospinal Fluid (CSF)|CSF sorafenib level was to be measured over time, and the means and standard errors of the sorafenib level were to be plotted at specific sampling time points. CSF sorafenib levels may also have been correlated with patients’ PFS, OS, or cytology using descriptive statistical methods (e.g., KM analysis stratified by high vs. low CSF sorafenib levels). The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
83990|NCT00964743|Secondary|Number of Participants With Overall Survival (OS)|Several secondary endpoints were to be analyzed in a descriptive fashion. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
83991|NCT00964743|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Kaplan-Meier analysis of PFS was to be performed and the PFS at 6 months in the study patients were be empirically described. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.|||||
83992|NCT00964743|Primary|Number of Participants With Adverse Events (AEs)|Safety and tolerability of sorafenib with DepoCyt. Toxicities were to be reported using tables and descriptive statistics by type and grade. All patients were to be followed up until death.|6 Months|All participants||participants|||Number
83993|NCT00964548|Secondary|Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Mean flow velocities of vessel in vasospasm (Change from baseline mean flow velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion|||cm/s||95% Confidence Interval|Mean
83996|NCT00964496|Primary|Cessation of Bleeding|The cessation of bleeding was defined as repeated negative faecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period. Rebleeding was defined based on a positive FOBT at any visit after treatment.|52 months|||participants|||Number
83997|NCT00964496|Secondary|Change From Baseline in Total Transfused Red Cell Requirements at 12 Months|Change of total transfused red cell requirements at 12 months after randomization from one year before baseline in transfusion dependent patients|baseline and 12 months|There are 14 participants depended on blood transfusion in each group||milliliter||Standard Deviation|Mean
83998|NCT00964496|Secondary|Participants Dependent on Blood Transfusions|Numbers of participants dependent on blood transfusions|52 months|55 patients were enrolled in our study. One in iron-controlled group refused to continue for personal reason after 8 months, two other in thalidomide plus iron group refused to take study medications after 4 weeks treatment due to leukopenia and unexplained somnolence. Analysis was performed according to Intention-to-Treat principle.||participants|||Number
83999|NCT00964496|Secondary|Change From Baseline in Bleeding Duration at 12 Months|The change from baseline in bleeding duration at 12 months|baseline and 12 months|||days||Standard Deviation|Mean
84000|NCT00964496|Secondary|Change From Baseline in Bleeding Episodes at 12 Months|The Change from baseline in bleeding episodes at 12 months|baseline and 12 months|||bleeding episodes||Standard Deviation|Mean
84001|NCT00964496|Secondary|Change From Baseline in Hemoglobin (Hb) Level at 12 Months|The change from baseline in average hemoglobin (Hb) level(tested every month) at 12 months.|baseline and 12 months|||g/L||Standard Deviation|Mean
84002|NCT00964496|Primary|Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months|The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Reduction of rebleeds = [(total bleeding episode at 12 months - total bleeding episodes at a year before randomization)/total bleeding episodes at a year before randomization(baseline)]*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.|baseline and 12 months|||participants|||Number
84003|NCT00964444|Primary|Force Exerted on a Fetus as the Delivery Occurs|The amount of force exerted on the fetus was measured in ounces. It was calculated based on measurements from the force transducers in the platform. The obstetrician stands or sits on the platform as the infant is delivered.|Assessment was done after the delivery|||ounces||Standard Deviation|Mean
84004|NCT00964431|Primary|Total Patient Pain Relief Over 0 to 8 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32."|8 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
84005|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
84006|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
84007|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever greater than or equal to [>=]38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours [hrs]); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs). Report of fever >40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
84029|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 8|ITT||Participants|||Number
84030|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 1, Week 2|ITT||Participants|||Number
84008|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
84009|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
84010|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.5 to 10.0 cm); Severe (greater than [>] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants||95% Confidence Interval|Number
84011|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||fold rise||95% Confidence Interval|Geometric Mean
84012|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||fold rise||95% Confidence Interval|Geometric Mean
84013|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||titers||95% Confidence Interval|Geometric Mean
84014|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||titers||95% Confidence Interval|Geometric Mean
84031|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No|Week 8|ITT||Participants|||Number
84032|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84015|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||mcg/mL||95% Confidence Interval|Geometric Mean
84016|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
84017|NCT00963235|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.||fold rise||95% Confidence Interval|Geometric Mean
84018|NCT00964366|Secondary|Skin Hydration|Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site.|2 weeks|ITT||Microsiemens||Standard Deviation|Mean
84019|NCT00964366|Secondary|Sebum Measurements|To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced.|2 weeks|ITT||units on a scale||Standard Deviation|Mean
84020|NCT00964366|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1through Day 14|ITT||Units on a scale||Standard Deviation|Mean
84021|NCT00964366|Secondary|Transepidermal Water Loss (TEWL)|To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale.|2 Weeks|||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
84022|NCT00964366|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|2 Weeks|ITT||Units on a scale||Standard Deviation|Mean
84023|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84024|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84025|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 8|ITT. All participants were asked to respond to the questionnaire.||Units on a scale||Standard Deviation|Mean
84026|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 1, Week 2|ITT. All participants were asked to respond to the questionnaire.||Units on a scale||Standard Deviation|Mean
84027|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 8|ITT||Participants|||Number
84028|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 1, Week 2|ITT||Participants|||Number
84033|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84034|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84035|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84036|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?|Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.|Week 1, Week 2|ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit.||Participants|||Number
84037|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84038|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84039|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84040|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84041|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84042|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84043|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84044|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84045|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84046|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84047|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84048|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84049|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
84050|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84051|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Global Score|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
88711|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||μU/μL||Standard Deviation|Mean
84052|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Functional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
84053|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Emotional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
84054|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Symptomatic Domain|"Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT||Units on a scale||Standard Deviation|Mean
84055|NCT00964223|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Week 5, Week 8|ITT||total acne lesions||Standard Deviation|Mean
84056|NCT00964223|Secondary|Non-Inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Week 5, Week 8|ITT||non-inflammatory acne lesions||Standard Deviation|Mean
84057|NCT00964223|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Week 5, Week 8|ITT||inflammatory acne lesions||Standard Deviation|Mean
84058|NCT00964223|Secondary|Investigator Static Global Assessment Score|ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
84059|NCT00964223|Secondary|Irritant/Allergic Contact Dermatitis Score|Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
84060|NCT00964223|Secondary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
84061|NCT00964223|Secondary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
84062|NCT00964223|Secondary|Erythema (Redness) Score|Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT||Units on a scale||Standard Deviation|Mean
84063|NCT00964223|Primary|Erythema (Redness) Score|Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84064|NCT00964223|Primary|Irritant/Allergic Contact Dermatitis Score|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face.~Erythema,peeling, and dryness were graded using the following scale:~0 None~Slight~Moderate~Intense"|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84065|NCT00964223|Primary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.|Week 1, Week 2|ITT||Units on a scale||Standard Deviation|Mean
84066|NCT00964223|Primary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|Intent-to-Treat (ITT) Population||Units on a scale||Standard Deviation|Mean
84067|NCT00964119|Primary|Skeletal Toxicities Related to the Use of Isotretinoin|Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy|Baseline to 5 months post therapy|Pilot observational study; Principal Investigator left sponsoring institution, data analysis not completed. Data analysis based on interim data (12 subjects). No manuscript published. No final analysis expected. Study has been closed with the local IRB and files archived.||U/L||Standard Deviation|Mean
84068|NCT00963937|Secondary|Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment|Rescue medication included one of the following: a single oral dose of a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, not to exceed the maximum recommended single dose; and anti-emetics (a drug to prevent vomiting).|within 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the observed case dataset, a dataset without any imputation of missing data.||percentage of participants|||Number
84101|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 28|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
84102|NCT00963872|Secondary|Neutrophil Engraftment|Achieving 500 neutrophils/uL by day 42.|Day 42|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84069|NCT00963937|Secondary|Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment|"Vomiting is one of the associated symptoms of a migraine. A participant was assessed as being free of vomiting when the symptom was recorded as absent at each time point in his or her patient diary. Vomiting was recorded as present for all subsequent assessments if a participant took a rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had vomiting at the time of treatment were included in the denominator.||percentage of participants|||Number
84070|NCT00963937|Secondary|Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Nausea is one of the associated symptoms of a migraine. A participant was assessed as nausea free when the symptom was recorded as absent at each time point in his or her patient diary. Nausea was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had nausea at the time of treatment were included in the denominator.||percentage of participants|||Number
84071|NCT00963937|Secondary|Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Phonophobia (sensitivity to sound) is one of the associated symptoms of a migraine. A participant was assessed as phonophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Phonophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had phonophobia at the time of treatment were included in the denominator.||percentage of participants|||Number
84072|NCT00963937|Secondary|Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Photophobia (sensitivity to light) is one of the associated symptoms of a migraine. A participant was assessed as photophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Photophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had photophobia at the time of treatment were included in the denominator.||percentage of participants|||Number
84073|NCT00963937|Secondary|Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment|Pain free was defined as a post-treatment pain intensity score of 1 on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took a rescue medication. The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 =mild, 3=mild to moderate, 4=moderate to severe, and 5=severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.||percentage of participants|||Number
84074|NCT00963937|Secondary|Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.||percentage of participants|||Number
84075|NCT00963937|Primary|Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|120 minutes post-treatment (Randomization through Final Visit [Week 6])|Full Analysis Set (FAS): all participants in the Safety Population (all participants who took >=1 dose of investigational product [IP]) who provided any post-treatment efficacy assessment. Analysis was performed on the last observation carried forward (LOCF) dataset (imputed by LOCF method). Only post-treatment values were used for imputation.||percentage of participants|||Number
84076|NCT00963924|Secondary|Side Effects Checklist (SEC)||Weeks 0 - 8, and Month 6 after cognitive remediation completion||||||
84077|NCT00963924|Secondary|Clinical Global Impression (CGI)||Weeks 0 and 8, and Month 6 after cognitive remediation completion||||||
84078|NCT00963924|Secondary|Calgary Depression Scale for Schizophrenia (CDSS)|Baseline scores on the Calgary Depression Scale for Schizophrenia (CDSS). Total CDSS scores range from 0-27. The assessment is comprised of 9 questions covering the topics of Depression, Hopelessness, Self Depreciation, Guilty Ideas of Reference, Pathological Guilt, Morning Depression, Early Wakening, Suicide, Observed Depression. Each item is scored on a scale from 0-3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The total score is computed by adding up the individual scores of each item. The higher the score, the more prominent the symptoms of depression are for the participant.|Baseline|||units on a scale||Standard Deviation|Mean
84079|NCT00963924|Secondary|Heinrich Quality of Life Scale (QoL)|Baseline scores of the Heinrich Quality of Life Scale, a 21 item scale designed and validated to measure intrapsychic foundations, interpersonal relations, instrumental role, and common objects and activities in patients diagnosed with Schizophrenia. Patients are rated on each of the 21 items on a scale of 0-6. Total scores are computed by adding up the scores of each individual item, with a total score ranging from 0-126. Higher scores reflect higher functioning.|Baseline|||units on a scale||Standard Deviation|Mean
84080|NCT00963924|Secondary|Global Assessment of Functioning Scale (GAS)|The Global Assessment of Functioning Scale (GAS) measured at baseline. This scale measures social, occupational, and psychological functioning, on a scale of 0-100. The higher the score, the greater a participant's functioning level.|Baseline|||units on a scale||Standard Deviation|Mean
84081|NCT00963924|Secondary|Scale for Assessment of Negative Symptoms (SANS)|The total scores from baseline and week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores are reported for baseline and week 8.|Baseline vs. Week 8|||units on a scale||Standard Deviation|Mean
84082|NCT00963924|Secondary|Positive and Negative Syndrome Scale (PANSS)|The baseline score on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. The higher a score the more prominent a positive symptom is.|Baseline|||units on a scale||Standard Deviation|Mean
84083|NCT00963924|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|Change of a composite score from baseline to week 8 on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). The MATRICS consists of 10 cognitive tasks that are used to calculate scores in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores on each cognitive task are transformed into t-scores, and then these scores are used to calculate the domain scores. The composite score is calculated by averaging all domain t-scores to come up with one overall cognitive composite t-score. For all scores on the assessment, the higher the score the better the performance on the task.|Baseline vs. Week 8|||Units on a scale||Standard Deviation|Mean
84084|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
84085|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
84086|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
84087|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84088|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84089|NCT00963872|Secondary|Overall Survival at Day 720|Survival (alive) from transplantation to last follow-up at day 720.|720 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84090|NCT00963872|Secondary|Non-relapse Mortality|Deaths not due to relapse.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84091|NCT00963872|Secondary|Incidence of Grades III-IV Graft-vs-host Disease|Development of graft-versus-host disease by day 100.|0 to 100 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84092|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 60|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
84093|NCT00963872|Secondary|Platelet Recovery|Number of patients with >20,000 platelets/uL by day 180|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84094|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84095|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84096|NCT00963872|Secondary|Chronic Graft-Versus-Host Disease|Patients who developed chronic graft-versus-host disease.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84097|NCT00963872|Secondary|Bone Marrow Chimerism|Percentage of donor DNA in the bone marrow.|Day 21|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||percentage of donor DNA||Standard Deviation|Mean
84098|NCT00963872|Secondary|Overall Survival|Survival (alive) from transplantation to last follow-up.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84099|NCT00963872|Secondary|Non-Relapse Mortality|Deaths not due to relapse.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84100|NCT00963872|Secondary|Incidence of Grades II-IV Graft-vs-host Disease|Development of graft-versus-host disease through day 100.|Day 0 through Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84103|NCT00963872|Primary|Number of Patients With the Complement 3a (C3a) Unit Predominating|Efficacy of the pre-incubation of one of two umbilical cord blood (UCB) units with C3a as part of a unrelated donor double UCB nonmyeloablative transplantation in patients with high-risk hematological malignancies.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.||participants|||Number
84104|NCT00963859|Primary|Overall Percentage Median Yield|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.|3 months including surgery and post-operative period.|||Percentage of Nodes (Node Yield)|||Number
84105|NCT00963859|Primary|Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.|3 months including surgery and post-operative period.|||Nodes (Node Yield)||Full Range|Median
84106|NCT00963820|Primary|Neurotoxicity Grading|Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.|Cycle 1 Day 1 and End of Study (Up to 354 days)|Safety Population included all randomized participants who received study drug.||score on a scale||Standard Deviation|Mean
84107|NCT00963820|Secondary|Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time|"Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~Partial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas.~Minimal Response (MR)= 25–49% reduction in serum paraprotein for 6 weeks. 50–89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25–49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25–49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions."|Up to 354 days|Response-Evaluable Population included all participants who had measurable disease at Baseline, had received at least 1 dose of study drug, and had at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
84108|NCT00963820|Secondary|TEmax: Time of Occurrence of Emax||Days 1 and 15 of Cycle 1|PD analysis population included all participants who had sufficient dosing data to calculate PD parameters||Hours||Standard Deviation|Mean
84109|NCT00963820|Secondary|Emax: Maximum Inhibition|A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m^2 cohort, so PD tables do not include that arm.|Days 1 and 15 of Cycle 1|PD analysis Population included all participants who had sufficient dosing data to calculate PD parameters||Percentage of inhibition||Standard Deviation|Mean
84110|NCT00963820|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN2238|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal phase elimination half-life.||hour||Standard Deviation|Mean
84111|NCT00963820|Secondary|Terminal Elimination Rate Constant (λz) for MLN2238|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body and the values were used for calculation of T1/2. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal elimination rate constant.||1/hour||Standard Deviation|Mean
84112|NCT00963820|Secondary|Accumulation Ratio: Day 15 AUC0-168 / Day 1 AUC0-168 for MLN2238|MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of accumulation ratio.||unitless||Standard Deviation|Mean
84113|NCT00963820|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for MLN2238|AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC[0-tau]), where tau is the length of the dosing interval - 168 hours in this study). MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of AUC(0-168).||hr*ng/mL||Standard Deviation|Mean
84114|NCT00963820|Secondary|Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238|Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.||hours||Full Range|Median
84115|NCT00963820|Secondary|Cmax: Maximum Observed Plasma Concentration for MLN2238|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the Pharmacokinetic (PK) Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of Cmax.||ng/mL||Standard Deviation|Mean
84116|NCT00963820|Primary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events|"An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.~A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)|Safety Population included all randomized participants who received study drug.||participants|||Number
84117|NCT00963677|Secondary|Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet|The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.|1 hour (peri-intubation time)|||seconds||Standard Deviation|Mean
84118|NCT00963677|Primary|Number of the Patients With Successful Nasotracheal Intubation|After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.|1 hour(peri-intubation time)|||participants|||Number
84119|NCT00963638|Primary|Frequency/Duration of Muscle Cramps||30 days||||||
84120|NCT00963638|Primary|Change in Frequency of Leg Cramps|Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline).|30 days|||Cramps per week||Standard Deviation|Mean
84121|NCT00963599|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84122|NCT00963599|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84123|NCT00963599|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84124|NCT00963599|Secondary|Mean Change From Baseline in Nasal Congestion Upon Awakening|Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84125|NCT00963599|Secondary|Mean Change From Baseline in Daytime Sneezing Score|Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84126|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Itching Score|Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84127|NCT00963599|Secondary|Mean Change From Baseline in Daytime Rhinorrhea Score|Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84128|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Congestion Score|Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84129|NCT00963599|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84130|NCT00963599|Secondary|Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)|Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84131|NCT00963599|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84132|NCT00963599|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84133|NCT00963560|Primary|Best Corrected Visual Acuity|Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.|6 Months after surgery|2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.||logMAR||Standard Deviation|Mean
84134|NCT00963508|Secondary|Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).|"The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.~Treatment Success in the Efficacy ITT (LOCF)"|3 weeks|Proportion of subjects that are lice free 14 days after their first treatment||percentage of subjects|||Number
84135|NCT00963508|Primary|Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)|"The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)~Treatment Success in the Efficacy ITT (LOCF)~index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))"|3 weeks|Efficacy: index subjects who had at least one application of treatment mITT: treated subjects who had at least one post-treatment visit Subjects with missing efficacy data were included first LOCF and then with non-LOCF PP: subjects who complied with the protocol, completed all required visits Safety: all subjects who had at least one treatment||percentage of subjects|||Number
84136|NCT00963482|Secondary|Drinking in the Last 7 Days (Patients Report + Urine Sample)||6 months||||||
84137|NCT00963482|Primary|Number of Smoke-free Patients|"Smoke-free defined with following measures:~patients self-report about smoking in the last 7 days (yes/no)~CO-level (smoke-free <10ppm)~urine sample (cotinine)"|6 months|Intention-to-treat analysis||participants|||Number
84138|NCT00963469|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
84139|NCT00963469|Secondary|Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
84140|NCT00963469|Secondary|Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Scores on a scale||95% Confidence Interval|Least Squares Mean
84380|NCT00961662|Primary|Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus|The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).|6 months from baseline|ITT Population||participants|||Number
84141|NCT00963469|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
84142|NCT00963469|Secondary|Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period|Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
84143|NCT00963469|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included||Scores on a scale||95% Confidence Interval|Least Squares Mean
84144|NCT00963469|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Nasal Symptoms Score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included.||Scores on a scale||95% Confidence Interval|Least Squares Mean
84145|NCT00963430|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the ITT safety cohort.||Participants|||Number
84146|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
84147|NCT00963430|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All live births are included in this outcome measure, which excludes 2 participants whose pregnancies ended in miscarriage or stillbirth. Three participants gave birth to twins and one to triplets, each counted separately.||Participants|||Number
84148|NCT00963430|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.||Participants|||Number
84149|NCT00963430|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants at Day 21 post first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
84170|NCT00963157|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
84150|NCT00963430|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
84151|NCT00963430|Primary|Number of Participants Reporting Fever After Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84152|NCT00963430|Primary|Number of Participants Reporting Fever After First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84153|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84154|NCT00963430|Secondary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.||Participants|||Number
84155|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if a cord blood sample was collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 5 due to specimen processing errors at the time of sample collection.||Participants|||Number
84156|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if they had blood collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 3 due to specimen processing errors at the time of sample collection. Participants were analyzed as treated.||Participants|||Number
84157|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84158|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84159|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84160|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84161|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84162|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84163|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84164|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84165|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to eligibility deviation. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84166|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
84167|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
84168|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
84169|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
84995|NCT00955474|Secondary|Metabolic Risk Factors|Fasting glucose, fasting insulin, and fasting lipids (total cholesterol, HDL, LDL, and triglycerides) will be obtained at baseline and 8-weeks.|8 weeks|The study was terminated. Resources were no longer available to analyze the data. PI left the inpatient service where the study was conducted.|||||
84171|NCT00963157|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
84172|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84173|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84174|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84175|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84176|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84177|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84271|NCT00962741|Secondary|C-reactive Protein (CRP): PsA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/L||Standard Deviation|Mean
84178|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84179|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
84180|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
84181|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.||Participants|||Number
84182|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84183|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84184|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84185|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84432|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84186|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84187|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84188|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84189|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.||Participants|||Number
84190|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collection at the timepoint are included. Analyses are as treated.||Participants|||Number
84191|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.||Participants|||Number
84192|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84193|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84194|NCT00963157|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 365 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
84195|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84196|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to influenza-like illness. This outcome restricts to age stratum.||Participants|||Number
84197|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
84198|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to an eligibility deviation. This outcome restricts to age stratum.||Participants|||Number
84199|NCT00962871|Secondary|Early Changes in Viral Sequence Associated With Viral Suppression|Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.|Day 1, 5, 14, Week 4 and 6||||||
84200|NCT00962871|Secondary|Mean Change From Baseline in HBV-DNA log10|An acute virologic response was determined by change from baseline in HBV-DNA log10.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.||IU/mL||Standard Deviation|Mean
84201|NCT00962871|Primary|Mean Change From Baseline in Viral Quantitative e Antibody|An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.||Cut-off index (C.O.I.)||Standard Deviation|Mean
84233|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for PsA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84202|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants|||Number
84203|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants|||Number
84204|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.||percentage of participants|||Number
84205|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants|||Number
84206|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants|||Number
84207|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.||percentage of participants|||Number
84208|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
84209|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||titers||95% Confidence Interval|Geometric Mean
84210|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
84211|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."||mcg/mL||95% Confidence Interval|Geometric Mean
84212|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
84213|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||titers||95% Confidence Interval|Geometric Mean
84259|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
84214|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
84215|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."||mcg/mL||95% Confidence Interval|Geometric Mean
84216|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
84217|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."||fold rise||95% Confidence Interval|Geometric Mean
84218|NCT00962780|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."||titers||95% Confidence Interval|Geometric Mean
84219|NCT00962780|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies all participants who were evaluable for this measure and n signifies all participants who were evaluable for specified serotype for each treatment arm, respectively."||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
84270|NCT00962741|Secondary|Pain Assessment|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84220|NCT00962780|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.||fold rise||95% Confidence Interval|Geometric Mean
84221|NCT00962754|Secondary|Complications|notifications of complications|duration of admission|||participants|||Number
84222|NCT00962754|Secondary|Use of Diuretics|prescription of diuretic therapy|during days of admission|||participants|||Number
84223|NCT00962754|Primary|Duration of Admission at the Ward in Days|Duration of hospital stay in days or duration of admission at the pediatric ward in days|1-8 months|intention to treat analysis||number of days||Full Range|Median
84224|NCT00962741|Other Pre-specified|Number of Participants With Neutralizing Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication.||Participants|||Number
84225|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: PsA Sub-population||Baseline up to Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a firstdegree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84226|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: ERA Sub-population||Baseline up to Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84227|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population||Baseline up to Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84228|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84229|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84230|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84231|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84232|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
88712|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||μU/μL||Standard Deviation|Mean
84234|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for ERA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84235|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for eoJIA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84236|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84237|NCT00962741|Other Pre-specified|Height z-Score by Age Group for PsA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84238|NCT00962741|Other Pre-specified|Height z-Score by Age Group for ERA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84239|NCT00962741|Other Pre-specified|Height z-Score by Age Group for eoJIA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA sub-population: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84240|NCT00962741|Other Pre-specified|Height z-Score by Age Group|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||z-score||Standard Deviation|Mean
84241|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for PsA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84433|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|Baseline|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84242|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for ERA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84243|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for eoJIA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84244|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84245|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): PsA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84246|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): ERA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|ERA:participants with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen-B27;Ar in male>6yrs; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84247|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): eoJIA Subpopulation|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84248|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Participants|||Number
84249|NCT00962741|Other Pre-specified|Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population|PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84250|NCT00962741|Other Pre-specified|Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of BSA||Standard Deviation|Mean
87402|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after second treatment|Safety population||cm||Full Range|Mean
84251|NCT00962741|Other Pre-specified|Modified Schober's Test for ERA Sub-population|Modified Schober’s Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||cm||Standard Deviation|Mean
84252|NCT00962741|Other Pre-specified|Nocturnal Back Pain Score for ERA Sub-population|Nocturnal back pain assessed by participant’s parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mm||Standard Deviation|Mean
84253|NCT00962741|Other Pre-specified|Overall Back Pain Score for ERA Sub-population|Overall back pain assessed by participant’s parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mm||Standard Deviation|Mean
84254|NCT00962741|Other Pre-specified|Tender Entheseal Assessment for ERA Sub-population|Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Tender entheses||Standard Deviation|Mean
84255|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84256|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar /enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84257|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84258|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84260|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;humanleukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
84261|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
84262|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants|||Number
84263|NCT00962741|Secondary|Duration of Morning Stiffness: PsA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
84264|NCT00962741|Secondary|Duration of Morning Stiffness: ERA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
84265|NCT00962741|Secondary|Duration of Morning Stiffness: eoJIA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
84266|NCT00962741|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Minutes||Standard Deviation|Mean
84267|NCT00962741|Secondary|Pain Assessment: PsA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84268|NCT00962741|Secondary|Pain Assessment: ERA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84269|NCT00962741|Secondary|Pain Assessment: eoJIA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
87403|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after first treatment|Safety population||cm||Full Range|Mean
84272|NCT00962741|Secondary|C-reactive Protein (CRP): ERA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/L||Standard Deviation|Mean
84273|NCT00962741|Secondary|C-reactive Protein (CRP): eoJIA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/L||Standard Deviation|Mean
84274|NCT00962741|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||mg/Liter (mg/L)||Standard Deviation|Mean
84275|NCT00962741|Secondary|Number of Joints With Limitation of Motion: PsA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84276|NCT00962741|Secondary|Number of Joints With Limitation of Motion: ERA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84277|NCT00962741|Secondary|Number of Joints With Limitation of Motion: eoJIA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84278|NCT00962741|Secondary|Number of Joints With Limitation of Motion|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84279|NCT00962741|Secondary|Number of Active Joints: PsA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84290|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84598|NCT00960076|Secondary|Change in FPG From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18|||mg/dL||Standard Error|Mean
84280|NCT00962741|Secondary|Number of Active Joints: ERA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84281|NCT00962741|Secondary|Number of Active Joints: eoJIA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84282|NCT00962741|Secondary|Number of Active Joints|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Joints||Standard Deviation|Mean
84283|NCT00962741|Secondary|Patient/Parent Global Assessment: PsA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84284|NCT00962741|Secondary|Patient/Parent Global Assessment: ERA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84285|NCT00962741|Secondary|Patient/Parent Global Assessment: eoJIA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84286|NCT00962741|Secondary|Patient/Parent Global Assessment|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84287|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84288|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84289|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Units on a scale||Standard Deviation|Mean
84291|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84292|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84293|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84294|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84295|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84296|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84297|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84298|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84317|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|"Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').~Scores for Symptoms 5, 10, and 11 on the MRS were summed and analyzed. Total summed scores ranged from 0 to 12, with higher scores representing more severe symptoms."|4 weeks from Baseline (Day 0)|||units on a scale||95% Confidence Interval|Mean
87404|NCT00933543|Secondary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||6 weeks after the first treatment|ITT||Participants|||Number
84299|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84300|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84301|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84302|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84303|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84304|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84305|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84306|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84353|NCT00962000|Secondary|Kt/V Determined From Measurements of Ionic Dialysance|Kt/VID was determined for all study treatments at 2 of the 3 centers using on-line clearance measurements (Gambro Diascan or Fresenius On-line Clearance Monitor).|4 weeks|||Kt/VID|Participants|Standard Deviation|Mean
84599|NCT00960076|Secondary|Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18|||mg/dL||Standard Error|Mean
84307|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84308|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with arthritis(Ar) or(/)enthesitis,any 2:sacroiliac joint tenderness/inflammatory(Ifm)lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;acute anterior uveitis(AAU)/AAU first-degree relative.||Percentage of participants||95% Confidence Interval|Number
84309|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84310|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).||Percentage of participants||95% Confidence Interval|Number
84311|NCT00962741|Primary|Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12|ACR Pedi 30 response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 12|Modified Intent-to-Treat (mITT) population included all participants who received at least 1 dose of the study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure at week 12.||Percentage of participants||95% Confidence Interval|Number
84312|NCT00962650|Primary|Completion of Diagnostic Peritineoscopy|"Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox~Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome."|Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar|The subject pool was limited to individuals scheduled for Rouen Y gastric bypass(Intent to Treat population). There was no statistical analysis. Success was based on completion of the diagnostic peritineoscopy procedure after transgastric access.||Participants|||Number
84313|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined|"The following analysis pre-specified the combining of all S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) into a single treatment group. The results from the Wilcoxon-Mann-Whitney test (pair-wise test), based on the change from Baseline at Week 4, are presented.~Note: Dryness of Vagina was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)|||units on a scale||95% Confidence Interval|Mean
84314|NCT00962585|Secondary|Mean Precentage Change in the Menopause Rating Scale Total Score From Baseline at Week 4|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: MRS consists of 11 symptoms, where each symptom is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Percentage Change||95% Confidence Interval|Mean
84315|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined|"The following analysis shows the results when the S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) are combined and regarded as a single treatment group.~Note: Each MRS symptoms was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)|||units on a scale||95% Confidence Interval|Mean
84316|NCT00962585|Post-Hoc|Percentage Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)|||Percentage Change||95% Confidence Interval|Mean
84366|NCT00961805|Secondary|Quality of Life - SF-36 - Social Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
84318|NCT00962585|Secondary|Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4|"MRS consists of 11 menopause symptoms. The scoring scheme is simple, i.e., the score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items (severity 0 [no complaints] 4 scoring points [extremely severe symptoms]). The respondent provides her personal perception by checking one of 5 possible boxes of severity for each of the items. The composite score (total score) is the sum of the 11 item scores, which can range from 0 (no symptoms) to 44 (extremely severe symptoms). Low total scores represent less severe menopause symptoms while higher scores represent more severe symptoms."|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||units on a scale||95% Confidence Interval|Mean
84319|NCT00962585|Secondary|Change From Baseline in Progesterone Concentration at Week 2 and Week 4|No repeated measures ANCOVA results are presented for change from Baseline in progesterone concentrations since the model did not converge.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Progesterone Concentration (nmol/L)||95% Confidence Interval|Mean
84320|NCT00962585|Secondary|Change From Baseline in Estradiol Concentration at Weeks 2 and 4|The LSMeans refer to overall adjusted mean estradiol concentration.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Estradiol Concentration (pmol/L)||95% Confidence Interval|Mean
84321|NCT00962585|Secondary|Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4|"The Vaginal Maturation Index was calculated by examining the maturation of the vaginal epithelium as adjudged by the cell types exfoliated. Parabasal cells are the least mature cells, intermediate cells display mild maturation, and superficial cells display the most maturity. The cell count is expressed as a percentage. The Vaginal Maturation Index was calculated as: 0.2*(parabasal cells, %)+0.6*(intermediate cells, %)+1.0*(superficial cells, %). This method is described in Menopause 2005;12(6):708-15.~The index serves as an objective means of evaluating hormonal secretion or response; lower values indicate more immature cells on the surface (atrophy), while higher values indicate more mature epithelium.~The LSMeans refer to overall adjusted mean percent of cells counted."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||percentage of cells||95% Confidence Interval|Mean
84322|NCT00962585|Secondary|Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4|"The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. The pH scale is logarithmic and as a result, each whole pH value below 7 is ten times more acidic than the next higher value.~Normal vaginal pH is 3.8 to 4.5, slightly acidic.~The LSMeans refer to overall adjusted mean pH."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||units on a scale||95% Confidence Interval|Mean
84323|NCT00962585|Secondary|Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4|"The severity of vasomotor symptoms per week at each of the protocol visits was calculated for each patient as follows: [(Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date – Previous protocol visit date (days)] * 7, where severity of vasomotor symptoms were scored as: 1 = mild, 2 = moderate and 3 = severe. Higher values represented worse severity.~LSMeans refer to the overall adjusted mean severity of VMS.~Hot Flush Classification: Mild: sensation of heat without sweating; Moderate: sensation of heat with sweating, able to continue activity; Severe: sensation of heat with sweating, causing cessation of activity.~Patients recorded the number of hot flushes (day and night) in their diaries related to the severity (mild/moderate/severe)."|1, 2, and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||units on a scale||95% Confidence Interval|Mean
84324|NCT00962585|Secondary|Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2|"The frequency of MSVS per week, at each of the protocol visits, was calculated as follows, for each patient: [# of Moderate+Severe hot flushes)/(Current protocol visit date–Previous protocol visit date (days)] * 7.~The ANCOVA procedure tested the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp, where μ1 and μp denote the mean frequency of MSVS, adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively.~LSMeans refer to the overall adjusted mean frequecy of MSVS."|1 and 2 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Number of MSVS/week||95% Confidence Interval|Mean
84325|NCT00962585|Secondary|Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period)|"Change from Baseline in the frequency of MSVS (difference between Baseline [period following first 7 days of 2-week run-in period] and period following first 7 days of 2-week Week 4 period), where the Baseline MSVS frequency was captured at visit 3 (Day 0), in the period following the first 7 days, as per CRF. Note: this endpoint is identical to the primary endpoint, however, instead of a 14 ± 2 day period, the period following the first 7 days was used, at Baseline and visit 3.~Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (period following first 7 days of 2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Number of MSVS/week||95% Confidence Interval|Mean
84367|NCT00961805|Secondary|Quality of Life - SF-36 - Vitality|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
87405|NCT00933543|Secondary|Absolute Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
84326|NCT00962585|Primary|Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period)|"The primary efficacy endpoint for this study was the change from Baseline (Day 0) in the frequency of MSVS (difference between Baseline [2-week run-in period] and Week 4), where the baseline MSVS frequency was captured over 14 ± 2 day period. Moderate is defined as “sensation of heat with sweating, able to continue activity”; severe is defined as “sensation of heat with sweating, causing cessation of activity”. Patients used the take-home daily diary to record MSVS information during the run-in period and treatment period and analyses were performed as specified.~Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.||Number of MSVS/2 weeks||95% Confidence Interval|Mean
84327|NCT00962208|Secondary|Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear||2 years||||||
84328|NCT00962208|Secondary|Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups||2 years||||||
84329|NCT00962208|Primary|Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study|Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.|2 years|||mm||Standard Deviation|Mean
84330|NCT00962104|Secondary|Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks|The HAMD-17 was used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). Higher scores indicate greater symptom severity. The total score is the sum of the scores from HAMD-17 Items 1 through 17. The total score may range from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMD-17 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84331|NCT00962104|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks|Clinician-administered rating scale that assesses severity of anxiety and its improvement (or change) during course of treatment (Hamilton 1959; Riskind et al. 1987). Scale consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. Investigator talked to participant about participant's symptoms over previous week before study visit. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score=sum of 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMA-14 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84332|NCT00962104|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks|The CGI-ADHD-I is a single-item clinician rating of the clinician’s assessment of the participant’s improvement in ADHD symptoms in relation to the clinician’s total experience with ADHD participants. Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment (1=very much improved to 7=very much worsened).|Up to 10 weeks|All randomized participants with an endpoint CGI-ADHD-I value within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84333|NCT00962104|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks|The CGI-ADHD-S is a single-item clinician rating of the clinician’s assessment of the overall severity of the participant’s ADHD symptoms in relation to the clinician’s total experience with ADHD participants. Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill to 7=among the most extremely ill participants).|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CGI-ADHD-S result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84334|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75-225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84335|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75- 225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
87406|NCT00933543|Secondary|Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count||6 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
84336|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|Participant assessment of symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-S:SV result were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
84337|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|CAARS-Inv:SV assesses symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as a covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
84338|NCT00962104|Secondary|Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline EQ-5D result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84339|NCT00962104|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks|Participant-reported outcome measure used to examine disease-specific functional impairments and QoL for adults with ADHD. The domains include work functioning, family relationships, social functioning, activities of daily living (that is, driving, managing finances), and psychological adaptation (that is, life satisfaction and self-esteem). Individual items scored on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). Range of scores for this subscale is 0 to 100. Consistent with the majority of existing QoL measures, higher scores on AAQoL-29 indicate better functioning.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline AAQoL result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84340|NCT00962104|Primary|Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks|CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result within each treatment group, last observation carried forward (LOCF) were included in the analysis.||units on a scale||Standard Deviation|Mean
84341|NCT00962065|Secondary|Change From Baseline at Day 28 in Triglycerides||Baseline to Day 28|||mg/dL||95% Confidence Interval|Mean
84342|NCT00962065|Secondary|Change From Baseline at Day 28 in Mean Arterial Pressure||Baseline to Day 28|||mm Hg||95% Confidence Interval|Mean
84343|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma Fructosamine Level||Baseline to Day 28|||µmol/L||95% Confidence Interval|Mean
84344|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma HbA1c||Baseline to Day 28|||Percent||95% Confidence Interval|Mean
84345|NCT00962065|Secondary|Change From Baseline at Day 29 in Fasting Plasma Glucose||Baseline to Day 29|||mg/dL||95% Confidence Interval|Mean
84346|NCT00962065|Primary|Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion|To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.|Baseline to Day 28|||grams||95% Confidence Interval|Mean
84347|NCT00962013|Secondary|Post-surgery Femoral Crack/Fracture and Subsidence Rate||Post-op to 5 years|Post-surgery femoral crack/fracture and subsidence rate were assessed by hip.||percentage of hips|Participants||Number
84348|NCT00962013|Primary|Femoral Stem Fracture||5 years|Participants who received the Restoration Modular Hip System.||femoral stem fractures|||Number
84349|NCT00962013|Secondary|SF-36 Health Status Survey: Role - Physical|"Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state:~The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health~This Secondary Outcome Measure is focused on the Role-Physical score."|pre-op, 2 year and 5 year|SF-36 Scores were assessed for each hip. (One hip did not have a pre-operative SF-36)||units on a scale|Participants|Standard Deviation|Mean
84350|NCT00962013|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|pre-op and 5 years|||units on a scale|Participants|Standard Deviation|Mean
84351|NCT00962013|Secondary|Radiographic Stability|Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.|5 years|41 hips had fully evaluable radiographs at the 5 year interval.||stable hips|Participants||Number
84352|NCT00962013|Primary|Stem Survivorship (%)|Failure is defined by stem revision for any cause.|5 years|Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years.||stem survivorship percentage at 5 years|Participants|90% Confidence Interval|Number
84354|NCT00962000|Secondary|Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. The formula for equilibrated Kt/Vurea takes urea rebound into consideration. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).|4 weeks|||equilibrated Kt/Vurea (eKt/V)|Participants|Standard Deviation|Mean
84355|NCT00962000|Primary|Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|"The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the single-pool Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA)."|4 weeks|||single-pool Kt/Vurea (spKt/V)|Participants|Standard Deviation|Mean
84356|NCT00961896|Primary|Number of Participants With at Least Partial Clinical Clearance (Part I)|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|day 8, day 15, day 22, day 29|All part I participants were included in the analysis.||Number of participants|||Number
84357|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part II)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.||Percent change in tumor measurement|Participants|Standard Deviation|Mean
84358|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part I)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks|All part I participants were included in this analysis.||Percent change in tumor measurement|Participants|Standard Deviation|Mean
84359|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part II)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated.. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.||percent change in tumor measurement||Standard Deviation|Mean
84360|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part I)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks|All part I participants were included in the analysis.||Percent change in tumor measurement||Standard Deviation|Mean
84361|NCT00961896|Primary|Percentage of BCCs With Complete and at Least Partial Clinical Clearance|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|4 weeks, 6 weeks, 9 weeks|All participants were analyzed.||Percentage of BCCs|Participants||Number
84362|NCT00961805|Secondary|Self-image - Body Dysmorphic Disorder Examination Questionnaire|scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image|Baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
84363|NCT00961805|Secondary|Depression - Beck Inventory|score between 0 from 63, with higher score indicating greater depression|Baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
84364|NCT00961805|Secondary|Quality of Life - SF-36 - Mental Health|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
84365|NCT00961805|Secondary|Quality of Life - SF-36 - Emotional Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks|||units on a scale||Standard Deviation|Mean
87407|NCT00933543|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Count||6 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
84381|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.|Baseline, Week 6|PP: All subjects who received study drug, satisfied inclusion/exclusion criteria, and had at least 1 scheduled on-therapy visit. Individual subject visits or data points were excluded if protocol criteria were violated at a subset of the subject's visits and the violations, in the opinion of the Medical Monitor, did not invalidate remaining visits.||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
84382|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).|Baseline, Week 6|ITT: All subjects who received study drug and had at least 1 scheduled on-therapy study visit.||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
84383|NCT00961636|Secondary|Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).||Participants|||Number
84384|NCT00961636|Primary|Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).||Participants|||Number
84385|NCT00961532|Secondary|Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)|We prospectively defined acute adverse events as: new fever >=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP < 100 mm Hg or new vasopressor use or increase in vasopressor dose by >25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.|within 6 hours of study treatment|||participants|||Number
84386|NCT00961532|Primary|Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment|The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.|60 minutes after treatment start|||seconds||Standard Error|Mean
84387|NCT00961441|Secondary|Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.|From Starting Study Drug Treatment (Day 1) to up to 14 days|Safety Set includes all subjects who took at least one dose of study medication. The Safety Set is identical to the Intention-to-treat (ITT) population in this study.||Count|||Number
84388|NCT00961441|Primary|Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration|The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population||L/h||Geometric Coefficient of Variation|Geometric Mean
84389|NCT00961441|Primary|Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration|The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population||hours (h)||Full Range|Median
84600|NCT00960076|Primary|Change in HbA1c Level From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18|||Percent||Standard Error|Mean
84390|NCT00961441|Primary|Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration|"AUCtau normalized by 1000 mg dose was calculated as:~AUCtau/(mg dose taken/ 1000 mg Keppra XR).~AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken).~6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population||µg*h/mL||95% Confidence Interval|Geometric Mean
84391|NCT00961441|Primary|Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration|"The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose.~Cmax normalized by 1000 mg dose was calculated as:~Cmax/(mg dose taken/ 1000 mg Keppra XR).~Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~Cmax/(bodyweight (kg)/ mg dose Keppra XR taken).~Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population||µg/mL||95% Confidence Interval|Geometric Mean
84392|NCT00961415|Secondary|Quality of Life|European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire–Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire–Lung Cancer 13 [EORTC QLQ-LC13]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles.|Up to 21 months|The ITT population included all the participants that were randomized.||Score on scale||Standard Deviation|Mean
84393|NCT00961415|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10^9/L), for White blood cells (WBC) was 3.0-18.0 (10^9/L), for Lymphocytes was 0.70-7.60 (10^9/L), and Neutrophil 1.50-9.25 (10^9/L ).|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.||Participants|||Number
84394|NCT00961415|Secondary|Incidence of Adverse Events and Serious Adverse Event|An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.||Participants|||Number
84395|NCT00961415|Secondary|Duration of Disease Control During Maintenance Treatment Phase|Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.||Months||95% Confidence Interval|Median
84396|NCT00961415|Secondary|Duration of Response During Maintenance Treatment Phase|Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.Participants available at particular time point for assessment were included in the analysis.||Months||95% Confidence Interval|Median
84397|NCT00961415|Secondary|Best Overall Response Rate During Maintenance Treatment Phase|The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population which included all the participants that were randomized.||percentage of participants||95% Confidence Interval|Number
84398|NCT00961415|Secondary|Overall Survival During Maintenance Treatment Phase|Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.||Months||95% Confidence Interval|Median
84618|NCT00959946|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84399|NCT00961415|Primary|Progression Free Survival During Maintenance Treatment Phase|Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.||Months||95% Confidence Interval|Median
84400|NCT00961402|Secondary|PHQ-9|Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression|6 Months|||Score on a scale||Standard Deviation|Mean
84401|NCT00961402|Secondary|Edinburgh Postnatal Depression Scale|This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression.|6 Months|||Score on a scale||Standard Deviation|Mean
84402|NCT00961402|Secondary|7-Day Physical Activity Recall Interview|Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run).|6 months|||Number of physical activity minutes||Standard Deviation|Mean
84403|NCT00961402|Primary|Structured Clinical Interview for DSM-IV Axis I Disorders|This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression.|6 months|||percentage of participants|||Number
84404|NCT00961350|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 Months|Intent to Treat (ITT) Population||participants|||Number
84405|NCT00961350|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population||participants|||Number
84406|NCT00961350|Secondary|The Number of Subjects With “Treatment Success”|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 Months|Intent to Treat Population||participants|||Number
84407|NCT00961350|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 Months|Intent to Treat (ITT) Population||participants|||Number
84408|NCT00961350|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||participants|||Number
84409|NCT00961311|Secondary|Device Success|Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow.|1-3 days|||Percent of Participants|||Number
84410|NCT00961311|Secondary|Vessel Perforation (Clinical)|Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.|1-3 days|||Percent of Participants|||Number
84411|NCT00961311|Secondary|Major Adverse Cardic Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.|1-3 days|||Percent of Participants|||Number
84412|NCT00961311|Primary|Procedural Success|Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.|1-3 days|||Percent of Participants|||Number
84413|NCT00961298|Secondary|Irritable Bowel Syndrome Severity Scoring System|This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.|endpoint [12 weeks]|||scores on a scale||Standard Deviation|Mean
84414|NCT00961298|Secondary|Irritable Bowel Syndrome-Quality of Life Scale|"The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 not at all to 5 extremely or a great deal Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170."|endpoint [12 weeks]|||scores on a scale||Standard Deviation|Mean
84415|NCT00961298|Secondary|Hamilton Anxiety Rating Scale|"The HAM-A is a 14 question scale with five responses. Responses range from 0 not present to 4 very severe. The total score ranges from 0 to 56. Higher values represent a worse outcome."|endpoint [12 weeks]|||scores on a scale||Standard Deviation|Mean
84416|NCT00961298|Primary|Clinical Global Impression Scale|"The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.~The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 very much improved, 4 no change, and 7 very much worse."|endpoint [12 weeks]|per protocol||scores on a scale||Standard Deviation|Mean
84778|NCT00958308|Primary|To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.|Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.|Up to 40 days|||participants|||Number
84417|NCT00961259|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.||ng-hr/mL||Standard Deviation|Mean
84418|NCT00961259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the [AUC(0-t)] values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.||ng-hr/mL||Standard Deviation|Mean
84419|NCT00961259|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.||ng/mL||Standard Deviation|Mean
84420|NCT00961233|Primary|Tissue Eosinophil Counts|Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment|8 weeks|||# of eosinophils per high-power field||Standard Deviation|Mean
84421|NCT00961233|Secondary|Adrenal Insufficiency|Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.|8 weeks|||participants|||Number
84422|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After seventh course at 14 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84423|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After first course at 2 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84424|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84425|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84426|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84427|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84428|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84429|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84430|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|1 week after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
84431|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.|||||
87408|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline||12 weeks after first treatment|||participants|||Number
84434|NCT00961220|Primary|Overall Response Rate|"Based on changes in modified SWAT assessment, patient responses will be classified as complete clinical response (CCR), partial response (PR), stable disease (SD), or progressive disease (PD). SWAT provides an accurate and reproducible assessment of cutaneous disease involvement based on body surface area of involvement and lesional thickness.~CCR: No evidence of disease, 100% improvement for a duration of at least 4 weeks. PR: Greater than or equal to 50% decrease in SWAT score compared to baseline and improvement is maintained for at least 4 weeks. SD: Less than 50% decrease in SWAT score compared to baseline. PD: Increase of greater or equal to 25% of the SWAT score compared to baseline while the patient is actively taking the study drug"|Up to 2 weeks after completion of study treatment|Intention to treat||participants|||Number
84435|NCT00961181|Secondary|Device Success|"Device success defined as exact deployment of the device as documented by two different projections assessed by quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)|||participants|||Number
84436|NCT00961181|Secondary|Technical Success|"Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)|||participants|||Number
84437|NCT00961181|Secondary|Binary In-segment Restenosis|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||participants|||Number
84438|NCT00961181|Secondary|Binary In-stent Restenosis|"In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||participants|||Number
84439|NCT00961181|Secondary|In-segment Diameter Stenosis (%DS)|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||percentage of re-narrowing||Standard Deviation|Mean
84440|NCT00961181|Secondary|In-stent Diameter Stenosis (%DS)|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||percentage of re-narrowing||Standard Deviation|Mean
84441|NCT00961181|Secondary|Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)|All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.|12 months|2 patients died, 2 patients withdrew consent, 1 patient lost to follow up||participants|||Number
84442|NCT00961181|Secondary|Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)|"All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.~Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR"|6 months|2 patients died, 2 patients withdrew consent||participants|||Number
84443|NCT00961181|Secondary|In-segment Late Lumen Loss|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||mm||Standard Deviation|Mean
84444|NCT00961181|Primary|In-stent Late Lumen Loss|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA||mm||Standard Deviation|Mean
87409|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count||12 weeks after last treatment|ITT||participants|||Number
84445|NCT00961116|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
84446|NCT00961116|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
84447|NCT00961116|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.||ng/mL||Standard Deviation|Mean
84448|NCT00961051|Secondary|Number of Subjects With no Corneal Staining|Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.|Day 180|||participants|||Number
84449|NCT00961051|Primary|Mean Lens Cleanliness as Measured by Light Reflectance|Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).|Day 30|Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253).||light reflectance score||Standard Deviation|Mean
84450|NCT00960999|Secondary|Association Between Biomarkers, Primary Tumor Control Rate, and ≥ Grade 2 Radiation Pneumonitis||From start of treatment to 1 year||||||
84451|NCT00960999|Secondary|Distribution of Pulmonary Function Changes by Treatment Arm and Response||From start of treatment to end of follow-up.||||||
84452|NCT00960999|Secondary|Distribution of FDG-PET (Fluorodeoxyglucose) Standardized Uptake Value Changes as a Potential Measure of Treatment Response and Outcomes||From start of treatment to date of failure (local, regional or distant), death or last follow-up.||||||
84453|NCT00960999|Secondary|1-year Overall Survival and Disease-free Survival Rate||From start of treatment to 1 year||||||
84454|NCT00960999|Secondary|1-year Primary Tumor Control Rate||From start of treatment to 1 year||||||
84455|NCT00960999|Primary|Counts of ≥ Grade 3 Adverse Events (AE) Graded by CTCAE v4 (Common Terminology Criteria for Adverse Events) That Are Definitely, Probably, or Possibly Related to Treatment (DPPRT)|Number of patients with ≥ grade 3 AE occurring within 1 year of treatment (TRT) start and reported as DPPRT among this subset of CTCAE v4: pericardial effusion, pericarditis, restrictive cardiomyopathy, dysphagia, esophagitis, esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage, rib fracture, brachial plexopathy, recurrent laryngeal nerve palsy, myelitis, atelectasis, bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, bronchial/pulmonary/bronchopleural/tracheal fistula, hypoxia, bronchial/tracheal obstruction, pleural effusion, pneumonitis, pulmonary fibrosis, skin ulceration (thorax only), FEV1 (Forced Expiratory Volume) or FVC (forced vital capacity) decline, or grade 5 related to TRT. Each arm is considered independently. For each arm, >=5 of 38 analyzable subjects experiencing a grade ≥ 3 AE during the 1st year following TRT start would determine the respective TRT excessively toxic. For each arm this design provides 88% power with a 0.10 type I error rate.|From start of treatment to 1 year|First 38 eligible patients per arm who started treatment||participants|||Number
84456|NCT00960986|Secondary|Percentage of Patients Achieving Remission|Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||percentage of participants|||Number
84457|NCT00960986|Secondary|Percentage of Participants Achieving Response|Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||percentage of participants|||Number
84458|NCT00960986|Secondary|Time to Resolve Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Nausea onset up to nausea resolve (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||days||95% Confidence Interval|Median
84459|NCT00960986|Secondary|Time to Onset of Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Baseline to onset of nausea (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||days||95% Confidence Interval|Median
84779|NCT00958282|Secondary|Drug Craving|"On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale.~The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being very little to 100 being very much."|14 Weeks|||units on a scale||Standard Error|Mean
84460|NCT00960986|Secondary|Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks|The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix.|1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84461|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S)|The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84462|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale|The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84463|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale|The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84464|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale|The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84465|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale|The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84466|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|"The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix."|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84467|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score|The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.||units on a scale||Standard Error|Least Squares Mean
84468|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score|AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity.|Baseline, 1 week, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||units on a scale||Standard Error|Least Squares Mean
84469|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score|Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||units on a scale||Standard Error|Least Squares Mean
84470|NCT00960986|Secondary|Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. N = number of subjects with a baseline and post-baseline result at the Week 8 visit.||units on a scale||Standard Error|Least Squares Mean
84471|NCT00960986|Primary|Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.|1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.||units on a scale||95% Confidence Interval|Mean
84472|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
84473|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)|Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.|Baseline to Month 6|The 'Per Protocol' population was used for this analysis. The Per-Protocol population was defined as a subset population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
84474|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
84475|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.|Baseline to Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
84476|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)|The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.||percent change||95% Confidence Interval|Least Squares Mean
84477|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine|Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
84478|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip|Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
84479|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD|"DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
84480|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD|"DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
84481|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD|"DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
87410|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||12 weeks after the first treatment|ITT||Percent change from baseline||Standard Deviation|Mean
84482|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD|"DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
84483|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD|"DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
84484|NCT00960934|Primary|Percentage of Participants With Bone Neoplasms|"Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
84485|NCT00960934|Primary|Percentage of Participants With Kidney Stones|"Evidence of kidney stone(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
84486|NCT00960934|Primary|Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
84487|NCT00960934|Primary|Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.||Percentage of participants|||Number
84488|NCT00960934|Primary|Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)|"Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline (BL) and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
84489|NCT00960869|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population||participants|||Number
84490|NCT00960869|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population||participants|||Number
84491|NCT00960869|Secondary|The Number of Subjects With “Treatment Success”|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 months|Intent to Treat (ITT) Population||participants|||Number
84492|NCT00960869|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 months|Intent to Treat (ITT) Population||participants|||Number
84493|NCT00960869|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||participants|||Number
84494|NCT00960856|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.||ng-hr/mL||Standard Deviation|Mean
84780|NCT00958282|Primary|Cocaine-positive Urine Results|At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.|14 Weeks|||percentage of BE urine tests||Standard Deviation|Mean
84495|NCT00960856|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.||ng-hr/mL||Standard Deviation|Mean
84496|NCT00960856|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.||ng/mL||Standard Deviation|Mean
84497|NCT00960843|Secondary|Rate of Weight Loss kg/wk at Day 180|Rate of weight loss = (screening weight (kg) – weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).|Screening to Day 180|Per Protocol population||kg/week||Standard Deviation|Mean
84498|NCT00960843|Secondary|Mean Static Intraband Pressure at Day 180|Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)|Day 180|Per Protocol population. Note, one subject in the Intraband pressure arm did not provide static intraband pressure measurements at Day 180 and is thus excluded from the analysis.||mmHg||Standard Deviation|Mean
84499|NCT00960843|Primary|Percent Excess Weight Change at Day 180|Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.|Screening to Day 180|Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data.||percentage of excess weight at screening||Standard Deviation|Mean
84500|NCT00960687|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
84501|NCT00960687|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.||ng-hr/mL||Standard Deviation|Mean
84502|NCT00960687|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.||ng/mL||Standard Deviation|Mean
84503|NCT00960661|Secondary|Minor Hypoglycemia Rate Per Year|Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL)|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.||rate per year||Standard Deviation|Mean
84504|NCT00960661|Secondary|Major Hypoglycemia Rate Per Year|Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.||rate per year||Standard Deviation|Mean
84505|NCT00960661|Secondary|Daily Insulin Glargine Dose at Baseline and at Week 30|Daily Insulin Glargine Dose at baseline and at Week 30|Baseline, week 30|Participants analyzed were from the per protocol population (247, 263) with no missing data for this endpoint (247, 263, respectively).||IU/day||Standard Deviation|Mean
84506|NCT00960661|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30|Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).||mmHg||Standard Error|Least Squares Mean
84705|NCT00958880|Secondary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change (SPDSC) Form is a version of the Clinical Global Improvement-Severity scale adapted specifically for clinician ratings of social anxiety disorder symptom severity. The scale ranges from 0 to 5, with higher scores indicating more social anxiety symptoms severity (i.e., worse outcomes). We examined the change in SPDSC scores from baseline to a 1 month follow-up.|CGI change scores from baseline to 1 month follow-up|||units on a scale||Standard Deviation|Mean
84507|NCT00960661|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 30|Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).||mmHg||Standard Error|Least Squares Mean
84508|NCT00960661|Secondary|Change in Body Weight From Baseline to Week 30.|Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, week 30|Participants analyzed were 247 and 263, respectively. These were from the per protocol population (247, 263, respectively) with no missing data (247, 263, respectively).||kg||Standard Error|Least Squares Mean
84509|NCT00960661|Secondary|Change in Low Density Lipoprotein (LDL) From Baseline to Week 30|Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, Week 30|Participants included in the analysis = 232 and 245, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (232, 245, respectively).||mmol/L||Standard Error|Least Squares Mean
84510|NCT00960661|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to Week 30|Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).||mmol/L||Standard Error|Least Squares Mean
84511|NCT00960661|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).||mmol/L||Standard Error|Least Squares Mean
84512|NCT00960661|Secondary|Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.|Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 243 and 262, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (243, 262, respectively).||mmol/L||Standard Error|Least Squares Mean
84513|NCT00960661|Secondary|Percent of Participants Achieving HbA1c ≤ 6.5%.|Percent of participants achieving HbA1c ≤ 6.5%.|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).||percentage of participants|||Number
84514|NCT00960661|Secondary|Percentage of Participants Achieving HbA1C < 7.0%|Percentage of participants achieving HbA1C < 7.0%|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).||Percentage of participants|||Number
84515|NCT00960661|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).|Baseline, 30 weeks|Participants analyzed for this endpoint included the per protocol population, 247 and 263, respectively.||percent of hemoglobin||Standard Error|Least Squares Mean
84516|NCT00960622|Primary|Change in Peak Oxygen Uptake.|change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.|baseline and 6 months|||ml/Kg/min||Standard Deviation|Mean
84517|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.||ng-hr/mL||Standard Deviation|Mean
84518|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.||ng-hr/mL||Standard Deviation|Mean
84519|NCT00960570|Primary|Maximum Plasma Concentration (Cmax) of Efavirenz|The maximum or peak concentration that efavirenz reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration.|30 subjects were enrolled in this study. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study interventions but withdrew consent prior to the 8 hour post-dose activities on Day 31.||ng/mL||Standard Deviation|Mean
84520|NCT00960531|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/ml||95% Confidence Interval|Geometric Mean
84521|NCT00960531|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|24 months|All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.||percentage of participants|||Number
84522|NCT00960531|Other Pre-specified|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)|IgG subtypes were not assessed|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgG subtypes were not assessed.|||||
84523|NCT00960531|Other Pre-specified|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not statistically analyzed.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not assessed.|||||
84524|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
84525|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
84526|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
84527|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||participants|||Number
84528|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
84554|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Month 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84529|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84530|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
84531|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84532|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
84533|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
84534|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||days||Standard Deviation|Mean
84535|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||days||Standard Deviation|Mean
84536|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||number of events||Standard Deviation|Mean
84537|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||number of events||Standard Deviation|Mean
84706|NCT00958880|Primary|The Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a self-report measure of social anxiety symptom severity. Scores range from 0 to 144, with higher scores indicating more social anxiety symptoms severity (i.e., a worse outcome).|LSAS means at 1 month follow-up|||units on a scale||Standard Deviation|Mean
84538|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84539|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84540|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
84541|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84542|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-FS:13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
84543|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue Scale (FS):13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84544|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||participants|||Number
84739|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol|Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and <40 mg/dL anytime post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had normal HDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.||percentage of participants|||Number
84545|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||participants|||Number
84546|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
84547|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84548|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
84549|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84550|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Month 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84551|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84552|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84553|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84762|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality||Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
87411|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT||Percent change from baseline||Standard Deviation|Mean
84555|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84556|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84557|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84558|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
84559|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84560|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84561|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
84562|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84563|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84564|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5 and 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84565|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84566|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84567|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84568|NCT00960440|Primary|Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84569|NCT00960440|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.||Units on a scale||Standard Deviation|Mean
84570|NCT00960440|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|Full Analysis Set(FAS):all randomized participants who received at least 1 dose of study treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
84571|NCT00960375|Primary|Abstinence From Tobacco|Self-reported abstinence from tobacco + breath CO < 10 ppm|7 days|All randomized to condition||participants|||Number
84572|NCT00960375|Primary|Number of Cigarettes Smoked Per Day|Number of cigarettes smoked per day for the last 7 days|day|All randomized||number of cigarettes||Standard Deviation|Mean
84596|NCT00960115|Primary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
84573|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew prior to Period II check-in. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 4 subjects in the Colchicine with Atorvastatin group.||pg*hr/mL||Standard Deviation|Mean
84574|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.||pg*hr/mL||Standard Deviation|Mean
84575|NCT00960323|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.||pg/mL||Standard Deviation|Mean
84576|NCT00960297|Secondary|To Assess Clinical & Pathologic Response Rate, Complete Resection Rate, Toxicity, Progression-free Survival, & Overall Survival.||60 months||||||
84577|NCT00960297|Primary|To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.||36 months|Study ended early due to slow accrual.|||||
84578|NCT00960206|Secondary|Hip Follow-Up Questionnaire|"A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as satisfied below); whether they have any study hip pain (noted as no pain below); and whether they have had any surgery on the study hip during the previous year noted as no surgery below)."|6-10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips with positive three question responses at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.||hips|Hips||Number
84579|NCT00960206|Secondary|Radiographic Evaluation|Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.|3-5 and 10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips demonstrating radiographic failure assessment at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.||hips|Hips||Number
84580|NCT00960206|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|3-5 and 10 Years|Participants may have one or both hips replaced. Number of participants and hips analyzed include all enrolled. Number of hips with HHS evaluated at postoperative periods indicated is included in the outcome results posting.||hips|Hips||Number
84581|NCT00960206|Primary|Component Revision and Complications|The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.|10 years|Number of participants analyzed includes all subjects enrolled.||hips|hips||Number
84582|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 2 subjects in the Colchicine with Seville orange juice group.||pg*hr/mL||Standard Deviation|Mean
84583|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.||pg*hr/mL||Standard Deviation|Mean
84584|NCT00960193|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.||pg/mL||Standard Deviation|Mean
84585|NCT00960154|Primary|Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen|Overall histological quality score will be a composite of the histological metrics|Intraoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
84586|NCT00960154|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
84587|NCT00960141|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84588|NCT00960141|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84589|NCT00960141|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2 (or upon discontinuation)|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84590|NCT00960141|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84591|NCT00960141|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84592|NCT00960141|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.||Units on a Scale||95% Confidence Interval|Least Squares Mean
84593|NCT00960115|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration.|Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
84594|NCT00960115|Secondary|Progression Free Survival (PFS) Time – Investigator Read|PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
84595|NCT00960115|Secondary|Time To Progression (TTP) – Investigator Read|TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration.|Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT Analysis Set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).||Months||95% Confidence Interval|Median
84597|NCT00960076|Secondary|Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)|Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set)|Week 18 (LOCF)|||Percentage of Participants|||Number
87412|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT||percentage change from baseline||Standard Deviation|Mean
84601|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)|The IGFBP-3 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-3 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-3 were not produced.|||||
84602|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2)|The IGFBP-2 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-2 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-2 were not produced.|||||
84603|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-2 (IGF-II)|IGF-II is generally produced locally in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-II were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-II were not produced.|||||
84604|NCT00960063|Secondary|Area Under the Curve During a Dosing Interval τ (AUCτ) for Robatumumab|AUCτ was defined as the area under the plasma concentration-time curve during a dosage interval (τ). Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCτ were not produced.|||||
84605|NCT00960063|Secondary|Area Under the Curve at the Time of Final Quantifiable Sample (AUCtf) for Robatumumab|AUCtf for robatumumab was defined as the area under the curve at the time of the final quantifiable sample of robatumumab. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCtf were not produced.|||||
84606|NCT00960063|Secondary|Time to Maximum Observed Concentration (Tmax) of Robatumumab|Tmax was defined as time of Cmax of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Tmax were not produced.|||||
84607|NCT00960063|Secondary|Number of Participants Who Developed Anti-robatumumab Antibodies|The incidence of anti-robatumumab antibodies was to be assessed. Only participants who had a negative pre-treatment sample and a post-treatment sample were considered to be evaluable. If a participant had a single sample considered positive in the anti-robatumumab antibody assay (with the exception of pre-treatment positive participants), then they would be counted as positive in the immunogenicity assessment.|Prior to 1st and 8th doses of robatumumab, ~30 days after last dose of study drug, and 4 months after last dose of study drug (Up to ~13.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy and had a negative pre-treatment sample and a post-treatment sample.||Participants|||Number
84812|NCT00958126|Secondary|Duration of Solicited Local Adverse Events After the First Vaccination||During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.||days||Standard Deviation|Mean
84608|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-I (IGF-I)|IGF-I is produced largely by the liver in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-I were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-I were not produced.|||||
84609|NCT00960063|Secondary|Maximum Observed Concentration (Cmax) of Robatumumab|Cmax was defined as the maximum observed serum concentration of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab pharmacokinetics (PK) were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Cmax were not produced.|||||
84610|NCT00960063|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were to be identified as target lesions. Data were to be collected at Screening, every 6 weeks and at 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last). The best overall response was to be the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): >20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions; or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening, every 6 weeks and at ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.||Participants|||Number
84611|NCT00960063|Primary|Number of Participants With Dose Limiting Toxicities|Dose-limiting toxicity was defined by the following adverse events (AEs) that were considered possibly or probably related to either robatumumab or to its interaction with the chemotherapy regimen assigned: neutropenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 neutropenia with Grade ≥2 fever lasting 3 days; neutropenic infection; failure to recover to study entry/eligibility criteria laboratory requirement levels that resulted in a delay of 14 days between treatment cycles), thrombocytopenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 requiring a platelet transfusion on 2 separate days within a cycle) or all other AEs (Grade ≥3 [any duration] not ameliorable by supportive or symptomatic measures). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0) was to be used to grade AEs.|Up to ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.||Participants|||Number
84612|NCT00959946|Secondary|Plasma Decay Half-Life (t1/2) - Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was to be calculated as 0.693/λz.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84613|NCT00959946|Secondary|Terminal-Phase Disposition Rate Constant (λz) - Part 2|The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84614|NCT00959946|Secondary|Apparent Oral Clearance (CL/F) - Part 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84615|NCT00959946|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] - Part 2|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84616|NCT00959946|Secondary|Apparent Volume of Distribution (Vz/F) - Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84617|NCT00959946|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84619|NCT00959946|Secondary|Duration of Response (DR) - Part 2|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84620|NCT00959946|Secondary|Clinical Benefit Rate - Part 2|Percent of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. SD: neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84621|NCT00959946|Secondary|Progression Free Survival (PFS) - Part 2|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84622|NCT00959946|Secondary|Best Overall Response - Part 1|Best overall response based on investigator's disease status assessment. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. Progressive disease (PD): at least 20% increase in sum of LD of target lesions taking as a reference smallest sum of the recorded LDs since treatment start, or the appearance of 1 or more new lesions. Stable disease (SD): neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 1 Baseline, every 6 weeks up to 6 months|Per protocol (PP) population included participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine within a 21-day period, had a baseline and at least 1 post-baseline tumor assessment, and had no major protocol violations.||Participants|||Number
84623|NCT00959946|Primary|Percentage of Participants With Objective Response - Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions (LDs) of the target lesions taking as a reference the baseline sum LDs.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
84624|NCT00959946|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after last dose of study treatment|Safety population: included participants who received at least 1 dose of the study medication.||Percentage of Participants|||Number
84625|NCT00959946|Primary|Maximum Tolerated Dose (MTD) - Part 1|The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level.|Part 1 Baseline up to Day 21|DLT evaluable population included all participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine in the first 21 days of treatment or had experienced a DLT within the first 21 days of treatment. N (number of participants analyzed) signifies participants who were evaluable for this measure.||mg|||Number
84626|NCT00959920|Secondary|Difference in Cost Between the Two Interventions: Intermittent vs. Foley Catheterization.||End of study.||||||
84627|NCT00959920|Primary|Time to Delivery (by Any Route)|Time to delivery defined as IV placement to delivery of infant.|1 day|Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.||Hours||Inter-Quartile Range|Median
84628|NCT00959907|Primary|Horizontal Action Halo Diameter at 112 Days|Minor’s test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|112 days|Intention to treat analysis. 55 volunteers - One drop out from visit 2 (28 days) to visit 3 (112 days): 54 volunteers.||centimeter||Standard Deviation|Mean
84629|NCT00959907|Primary|ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)|ECMAP(Evoked Compound Muscle Action Potentials) was accessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days|||microvolts||Standard Deviation|Mean
84842|NCT00957944|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL) * kg||Standard Deviation|Mean
84630|NCT00959907|Primary|Horizontal Action Halo Diameter at 28 Days|Minor’s test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|28 days|The analysis was intention to treat (ITT); One drop out, from baseline to visit 1(intervention) and 3 drop outs from visit 1 to visit 2 (28 days after botulinum toxin injections). Started 59 volunteers - 4 drop outs, there was 55 volunteers in the first analysis.||centimeter||Standard Deviation|Mean
84631|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.||ng*hr/mL||Inter-Quartile Range|Median
84632|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.||ng/mL||Inter-Quartile Range|Median
84633|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
84634|NCT00959894|Secondary|Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome measure assessed the ratio of semen:plasma concentration of etravirine in paired semen and plasma samples collected from 14 male participants at Week 4 of treatment with etravirine and fixed dose tenofovir/emtricitabine.|4 weeks|Of 79 participants who initiated study medications, 14 provided paired plasma and genital secretion samples. The goal was to enroll a total of 20 participants (10 men and 10 women) into the genital secretion sub-group, however no women enrolled into this subgroup. Data are presented for semen and plasma etravirine concentrations for 14 men.||ratio of semen:plasma drug concentration||Inter-Quartile Range|Median
84635|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
84636|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||percentage of body fat||95% Confidence Interval|Median
84637|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.||percentage of body fat||95% Confidence Interval|Median
84647|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 96 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 96 weeks|Of 79 participants who initiated study medications, 63 had a Week 48 CD4+ cell count measurement (6 discontinued study participation prior to Week 96 and 10 were lost to follow-up).||cells/uL||95% Confidence Interval|Median
84638|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||µU/ml*mmol/L||Inter-Quartile Range|Median
84639|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||mg/dL||Inter-Quartile Range|Median
84640|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||µU/ml*mmol/L||Inter-Quartile Range|Median
84641|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||mg/dL||Inter-Quartile Range|Median
84642|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||µU/ml*mmol/L||Inter-Quartile Range|Median
84643|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.||mg/dL||Inter-Quartile Range|Median
84644|NCT00959894|Secondary|Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks|The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood’s variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring).|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.||proportion of participants||95% Confidence Interval|Number
84645|NCT00959894|Secondary|Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy|"The safety/tolerability endpoint was defined as the first grade 3 or higher sign, symptom or laboratory abnormality that was at least one grade higher than baseline among participants ever exposed to etravirine (regardless of treatment status), or permanent discontinuation of etravirine due to any toxicity (regardless of grade). Modification of tenofovir/emtricitabine was not a safety/tolerability event.~The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood’s variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring)."|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.||participants|||Number
84646|NCT00959894|Secondary|Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results|Per-protocol, genotype testing was conducted at confirmation of virologic failure if the confirmatory HIV-1 RNA was above the laboratory-specified threshold of 500 copies/mL. HIV-1 genotype was determined using the TRUGENE® HIV-1 assay (Siemens Healthcare Diagnostics, Tarrytown, NY)|96 weeks|Of participants with confirmed virologic failure, 8 had HIV-1 RNA levels ≥ 500 copies/mL and 6 of these had viral genotype results available (1 had previously discontinued study medication at Week 2, and 1 was missing).||participants|||Number
87413|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||6 weeks after first treatment|ITT||percentage change from baseline||Standard Deviation|Mean
84648|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 48 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 CD4+ cell count measurement (4 discontinued study participation prior to Week 48 visit, 3 were lost to follow-up, and 3 missed the Week 48 visit).||cells/uL||95% Confidence Interval|Median
84649|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol analysis of change in CD4+ cell count from baseline to Week 24 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% confidence interval (CI).|Baseline to 24 weeks|Of 79 participants who initiated study medications, 73 had a Week 24 CD4+ cell count measurement (4 discontinued study participation prior to Week 24,1 missed the Week 24 visit, and 1 did not have a Week 24 CD4+ cell count measurement).||cells/uL||95% Confidence Interval|Median
84650|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA 200 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
84651|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
84652|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 24 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement (3 participants had discontinued the study, 1 was lost to follow-up, and 1 missed the Week 24 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
84653|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
84654|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
84655|NCT00959894|Primary|The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24|The primary study endpoint was the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA <50 copies/ml during the Week 24 analysis window (>18 and <30 weeks post-entry).|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement. The primary analysis was conducted intention-to-treat, with missing evaluations counted as failure.||proportion of participants||95% Confidence Interval|Number
84656|NCT00959764|Secondary|Change in Plasma CTx-1 From Baseline|Percent change from baseline of plasma CTx-1 at end of study=48 weeks|48 weeks|Modified Intent-to-Treat Population||Percentage change from baseline||Standard Deviation|Least Squares Mean
84657|NCT00959764|Secondary|Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)|Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.|24 weeks|Modified Intent-to-Treat Population||percentage change from baseline||Standard Deviation|Least Squares Mean
84658|NCT00959764|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine|Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.|48 weeks|Patients who were randomized, received treatment, and had at least one post-baseline BMD value measured at least 154 days after randomization.||Percentage increase from baseline||Standard Deviation|Least Squares Mean
84659|NCT00959751|Post-Hoc|Sustained Complete Headache Relief (Efficacy Evaluable Analysis Set)|Exploratory Post-hoc Analysis: Sustained complete headache relief is defined as a reduction in headache severity from moderate or severe to absent over all indicated time points.|2 - 48 hours|Efficacy Evaluable Analysis Set includes all subjects in the Full Analysis Set with an observed or imputed HSS (using rules predefined in the Statistical Analysis Plan [SAP]) at both the 2-hour time point and the 4-hour time point when using the modified LOCF approach||Participants|||Number
84660|NCT00959751|Secondary|Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)|Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent|24 hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.||Participants|||Number
84661|NCT00959751|Secondary|Time (Hours) to First Use of Rescue Medication (Full Analysis Set)|Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.|24 Hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.||Participants who required rescue||95% Confidence Interval|Median
84662|NCT00959751|Primary|Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache recurrence is defined as any subject that experiences headache relief at the given time point (i.e., 2 hours or 4 hours), who did not use rescue medication and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration. The denominator is the number of subjects who experienced headache relief at 2 hours/4 hours.|4 hours|30 and 42 placebo and NXN-188 subjects, respectivley, experienced headache relief at 2 hours. 41 and 55 placebo and NXN-188 subjects, respectively, experienced headache relief at 4 hours.||Participants|||Number
84663|NCT00959751|Secondary|Complete Headache Relief (Efficacy Evaluable Analysis Set)||72 hours|||Participants|||Number
84664|NCT00959751|Secondary|Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours|||Participants|||Number
84665|NCT00959751|Secondary|Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours|||Participants|||Number
84666|NCT00959751|Primary|Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.|2 hours|Modified LOCF - Efficacy Evaluable Analysis Set||Participants|||Number
84667|NCT00959699|Secondary|Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound|Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||percentage of participants|||Number
84668|NCT00959699|Secondary|Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)|This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Baseline and Week 4|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||participants|||Number
84669|NCT00959699|Secondary|Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)|The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 60|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||percentage of participants|||Number
84670|NCT00959699|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24|EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 12|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. No participants had undetectable HCV-RNA at Week 2; the “n” value in the table below represents the number of participants with EVR at that time point.||percentage of participants|||Number
84671|NCT00959699|Secondary|Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)|SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving one dose of boceprevir (PegIFN-2b + RBV + Boceprevir group) or placebo to boceprevir (PegIFN-2b + RBV group), defined as the Modified Intent-to-Treat Population; this includes 2 participants who did not enter the Follow-up Period.||percentage of participants|||Number
84684|NCT00959192|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
84672|NCT00959699|Primary|Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication|SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.||percentage of participants|||Number
84673|NCT00959647|Primary|Percentage of Participants Who Discontinued Treatment Due to an Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.||Percentage of participants|||Number
84674|NCT00959647|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.||Percentage of participants|||Number
84675|NCT00959647|Secondary|Incidence of Adverse Events Leading to GDC-0449 Discontinuation||30 days following the last administration of study treatment||||||
84676|NCT00959647|Secondary|Incidence and Severity of All Adverse Events and Serious Adverse Events||30 days following the last administration of study treatment||||||
84677|NCT00959374|Secondary|Cosmesis|Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).|12 weeks|Subjects who did not return for the 12 week follow-up visit were excluded from the analysis.||units on a scale||Standard Deviation|Mean
84678|NCT00959374|Primary|Total Dermal Closure Time|In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.|At time of surgery|Includes only those subjects where a deep dermal layer was closed.||Minutes||Standard Deviation|Mean
84679|NCT00959192|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
84680|NCT00959192|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Z-score||Standard Deviation|Mean
84681|NCT00959192|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.|"The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.~A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction."|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
84682|NCT00959192|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
84683|NCT00959192|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
84704|NCT00958893|Primary|To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.||three 4 month cycles separated by off-drug intervals||||||
84685|NCT00959192|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
84686|NCT00959192|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
84687|NCT00959192|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
84688|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population||Days||Standard Deviation|Mean
84689|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population||Days||Standard Deviation|Mean
84690|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population||Days||Standard Deviation|Mean
84691|NCT00959049|Secondary|Serious Adverse Events (SAEs)||6 months after last study vaccination|Safety Population||Participants|||Number
84692|NCT00959049|Secondary|New Onset of Chronic Illnesses (NOCIs)|New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|6 months after last study vaccination|Safety population||Participants|||Number
84693|NCT00959049|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Events|30 days after each vaccination|Safety population||Participants|||Number
84694|NCT00959049|Primary|Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination|Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|30 days after the last study vaccination|Per-Protocol Population||Percentage of participants||95% Confidence Interval|Number
84695|NCT00959049|Primary|Geometric Mean Titer 30 Days After the Last Study Vaccination||30 days after the last study vaccination|Per-protocol population||Titers||95% Confidence Interval|Geometric Mean
84696|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population||Participants|||Number
84697|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78||Participants|||Number
84698|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110||Participants|||Number
84699|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Saline Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Saline|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with saline intervention.||pmol/L||Standard Deviation|Mean
84700|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Naloxone|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with Naloxone intervention.||pmol/L||Standard Deviation|Mean
84701|NCT00958919|Secondary|Endurance Time|Length of time that subjects were able to continue Resistive Load Breathing|Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.||minutes||Standard Deviation|Mean
84702|NCT00958919|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.~Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.||units on a scale||Standard Deviation|Mean
84703|NCT00958919|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.||units on a scale||Standard Deviation|Mean
84707|NCT00958841|Secondary|Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Six patients with Nelson’s syndrome met the responder’s criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.||Participants|||Number
84708|NCT00958841|Secondary|PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.||Participants|||Number
84709|NCT00958841|Secondary|PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.||Participants|||Number
84710|NCT00958841|Secondary|Percentage of Responders With Probability of Success at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson’s syndrome.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.||Percentage of participants|||Number
84711|NCT00958841|Secondary|Percentage of Responders at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.||percentage of participants|||Number
84712|NCT00958841|Primary|Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)|The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.||percentage of participants|||Number
84713|NCT00958828|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week’s wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per protocol||Units on a scale||Standard Deviation|Mean
84714|NCT00958776|Other Pre-specified|Change in Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; Fold Change From Initial|Viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented as fold change from initial sensitivity by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.||fold change||Standard Deviation|Mean
84715|NCT00958776|Other Pre-specified|Initial Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; IC50 (nM)|Initial viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.||nM||Standard Deviation|Mean
84776|NCT00958308|Secondary|Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.|If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.|Up to 40 days||||||
84716|NCT00958776|Other Pre-specified|Survival at 14 and 28 Days After Initiation of Study Drug (Kaplan-Meier Estimate)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Estimates and 95% confidence intervals were calculated using the method of Kaplan-Meier and presented by treatment group.|28 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||Percent Survival||95% Confidence Interval|Number
84717|NCT00958776|Other Pre-specified|Number of Subjects Requiring More Than 5 Days of Study Drug|Subjects who had not met the protocol-defined criteria of clinical resolution on Day 5 or who had detectable virus by RT-PCR from a sample collected on Study Day 4 after dosing continued their assigned treatment for a further 5 days.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||participants|||Number
84718|NCT00958776|Other Pre-specified|Incidence of Influenza-Related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis, and pneumonia as reported on the influenza-related complications CRF.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||participants|||Number
84719|NCT00958776|Other Pre-specified|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study treatment until the subject was discharged from the hospital, was summarized by treatment group using the method of Kaplan-Meier. Subjects who were not discharged from the hospital were censored at their last study visit.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||days||95% Confidence Interval|Median
84720|NCT00958776|Secondary|Duration of All ICU Admissions (Kaplan-Meier Estimate)|Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||days||95% Confidence Interval|Median
84721|NCT00958776|Secondary|Number of Subjects With ICU Admission|The number of subjects requiring ICU admission post-randomization was summarized by treatment group.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||participants|||Number
84722|NCT00958776|Secondary|Time to Resumption of Usual Activities|Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||days||95% Confidence Interval|Median
84723|NCT00958776|Secondary|Time to Resolution of Fever (Kaplan-Meier Estimate)|Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||hours||95% Confidence Interval|Median
84724|NCT00958776|Secondary|Time to Alleviation of Clinical Symptoms of Influenza|Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||hours||95% Confidence Interval|Median
84725|NCT00958776|Secondary|Change (Reduction) in Influenza Virus Titer|The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.|Baseline and 24, 48, 108 hours|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.||log10 viral particles/mL||95% Confidence Interval|Median
84726|NCT00958776|Primary|Time to Clinical Resolution (Kaplan-Meier Estimate)|Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain a NAI at randomization.||hours||95% Confidence Interval|Median
84727|NCT00958568|Other Pre-specified|Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)|Relapse is defined as meeting any of the following criteria (Relapse-any reason): 50% increase in MADRS score from randomization with concomitant CGI-S of Depression score increase to a score of 4 or more (MADRS score/CGI-S Depression Score); Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 27|All randomized participants.||percentage of participants||95% Confidence Interval|Number
84728|NCT00958568|Secondary|Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram||Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.||percentage of participants|||Number
84729|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)|Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval <500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.|Randomization (Week 20) to Week 47|All randomized participants who had <500 msec QTc interval at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.||percentage of participants|||Number
84730|NCT00958568|Secondary|Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia’s Formula (QTcF) on Electrocardiogram|Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.||milliseconds (msec)||Standard Error|Least Squares Mean
84731|NCT00958568|Secondary|Percent of Participants With Suicide-Related Thoughts and Behaviors|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) C-SSRS measurements.||percentage of participants|||Number
84732|NCT00958568|Secondary|Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%||Week 20 to Week 47|All randomized participants who had Week 20 and at least 1 post-baseline (Weeks 21-47) weight measurements.||percentage of participants|||Number
84733|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Weight|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) weight measurements.||kilograms (kg)||Standard Error|Least Squares Mean
84734|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Glucose|Impaired to High fasting glucose: ≥100 milligrams/deciliter (mg/dL) and <126 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to High glucose: <100 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to Impaired fasting glucose is <100 mg/dL at baseline, ≥100 mg/dL and <126 mg/dL any time post baseline; Normal/Impaired to High fasting glucose: <126 mg/dL at baseline and ≥126 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had impaired or normal glucose value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.||percentage of participants|||Number
84735|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Glucose|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
84736|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Triglycerides|Borderline to High fasting triglycerides: ≥150 milligrams/deciliter (mg/dL) and <200 mg/dL at baseline and ≥200 mg/dL any time post baseline; Normal to Borderline fasting triglycerides: <150 mg/dL at baseline, ≥150 mg/dL and <200 mg/dL any time post baseline; Normal to High fasting triglycerides: <150 mg/dL at baseline and ≥200 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal triglycerides value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglyceride measurements.||percentage of participants|||Number
84737|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Triglycerides|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglycerides measurement.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
84738|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Hepatic Events|Participants with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 times the upper limit of normal (ULN) at baseline, with ALT or AST >=3 times the ULN post-baseline and total bilirubin >=2 times ULN at the same time are considered having treatment-emergent hepatic events.|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and post-baseline (Weeks 21-47) hepatic function measurements.||percentage of participants|||Number
84740|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
84741|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol|Borderline to High fasting LDL cholesterol: ≥100 milligrams/deciliter (mg/dL) and <160 mg/dL at baseline and ≥160 mg/dL any time post baseline; Normal to Borderline fasting LDL cholesterol: <100 mg/dL at baseline, ≥100 mg/dL and <160 mg/dL any time post baseline; Normal to High fasting LDL cholesterol: <100 mg/dL at baseline and ≥160 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal LDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.||percent of participants|||Number
84742|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
84743|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol|Borderline to High fasting total cholesterol: ≥200 milligrams/deciliter (mg/dL) and <240 mg/dL at baseline and ≥240 mg/dL any time post baseline; Normal to Borderline fasting total cholesterol: <200 mg/dL at baseline, ≥200 mg/dL and <240 mg/dL any time post baseline; Normal to High fasting total cholesterol: <200 mg/dL at baseline and ≥240 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal cholesterol level at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.||percentage of participants|||Number
84744|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
84745|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Dyskinesia|Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of the participants. Treatment emergent dyskinesia is defined as a score ≥3 on any one of the AIMS items 1-7 post-baseline (Weeks 21-47) or scores ≥2 on any two of the AIMS items 1-7 post-baseline (Weeks 21-47) among participants without either criteria at baseline (Week 20).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) AIMS measurements.||percentage of participants|||Number
84746|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Parkinsonism|Simpson-Angus Scale is used to measure Parkinsonian-type symptoms in participants exposed to neuroleptics. The scale consists of 10 items, each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items and ranges from 0-40 with higher scores indicating worse conditions. Treatment emergent parkinsonism is defined as total score ≤3 of items 1 through 10 of the Simpson-Angus scale at baseline (Week 20) and a total score >3 of items 1 through 10 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) Simpson-Angus Scale measurements.||percentage of participants|||Number
84747|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Akathisia|Barnes Akathisia Scale (BAS) rates observable, restless movements of drug-induced akathisia as well as the subjective awareness of restlessness and any distress associated with the akathisia. It consists of 4 items. 3 items (objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness) rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. Item 4 (global clinical assessment of Akathisia) is derived from the responses on Items 1-3 rated on a 6-point scale, with 0 being absence and 5 being extreme Akathisia. Treatment emergent akathisia is defined as a global clinical assessment score on BAS <2 at baseline (Week 20) and a global clinical assessment score on BAS ≥2 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) BAS measurements.||percentage of participants|||Number
84748|NCT00958568|Secondary|Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work or school (Item 1), social (Item 2), and family life and home responsibilities (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) SDS score measurements. Last observation carried forward (LOCF) principle was used.||units on a scale||Standard Error|Least Squares Mean
84749|NCT00958568|Secondary|Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)|Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.|Randomization (Week 20) to Week 47|All randomized participants who provided information of psychiatric visits and emergency room or equivalent facility visits for psychiatric illness from Week 21 to Week 47.||visits per participant||Standard Deviation|Mean
84750|NCT00958568|Secondary|Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47||Week 47|All randomized participants who worked for pay at Week 47.||hours||Standard Deviation|Mean
84751|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) CGI-S measurements.||units on a scale||Standard Error|Least Squares Mean
84752|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements. LOCF principle was used.||units on a scale||Standard Error|Least Squares Mean
84753|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements.||units on a scale||Standard Error|Least Squares Mean
84754|NCT00958568|Secondary|Percentage of Participants Maintaining Remission|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
84755|NCT00958568|Secondary|Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).||percentage of participants|||Number
84756|NCT00958568|Secondary|Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).||percentage of participants|||Number
84757|NCT00958568|Secondary|Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 0 to Week 8|All participants who entered open-label acute treatment phase (SPII).||percentage of participants|||Number
84758|NCT00958568|Secondary|Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|"Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 197 and 160 for OFC and Flu groups, respectively.||days||Full Range|Median
84759|NCT00958568|Secondary|Time to Relapse as Measured by Hospitalization for Depression or Suicidality|"Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 217 and 220 for OFC and Flu groups, respectively.||days||Full Range|Median
84760|NCT00958568|Secondary|Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|"Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 190 and 160 for OFC and Flu groups, respectively.||days||Full Range|Median
84761|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
84763|NCT00958568|Secondary|Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill).|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
84764|NCT00958568|Secondary|Percentage of Participants Who Relapse by Any Criteria|Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.||percentage of participants|||Number
84765|NCT00958568|Primary|Time to Relapse by Any Criteria|"Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 186 and 152 for OFC and Flu groups, respectively.||days||Full Range|Median
84766|NCT00958360|Secondary|Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Overall Visual Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
84767|NCT00958360|Secondary|Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Motor Skills subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
84768|NCT00958360|Secondary|Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Information Processing subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
84769|NCT00958360|Secondary|Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Mobility subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
84770|NCT00958360|Primary|Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later|||logits||Standard Deviation|Mean
84771|NCT00958347|Primary|Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.||25 Years Post-Operatively|The study was closed and no subjects reached the 25 year postoperative endpoint.|||||
84772|NCT00958334|Secondary|Change From Baseline of ZPU-003 Ext to 14 Months in Subject's Menstrual Pictograms(Subjects Evaluable for Menorrhagia Only)||baseline and 14 months||||||
84773|NCT00958334|Primary|The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.|An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.|baseline, 14 months (3-4 cycles), 17 months|Intent to treat population||mL||Standard Deviation|Mean
84774|NCT00958308|Secondary|Frequencies of Other Gastrointestinal Symptoms.|Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.|Up to 40 days||||||
84775|NCT00958308|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.|Adverse events were reported by patients in the three study groups.|Up to 40 days||||||
84777|NCT00958308|Secondary|Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.|Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.|Up to 40 days||||||
84781|NCT00958256|Primary|Response Rate|Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.|Evaluation of disease after 2 cycles (approximately 6 weeks).|Twenty-one patients were evaluable for response assessment (100%), of whom 16 responded (76%) thus reflected are the percentage of responses to total responders (i.e. 11 (52%) of total evaluable achieved a complete response).||percentage of participants|||Number
84782|NCT00958243|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|Up to 180 days after the last vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
84783|NCT00958243|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"UAE grading:~Grade 1: Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities."|During the 21 days after each vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
84784|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. In Cohort B, Safety Population after the first vaccination are placebo group 28, 7.5 mcg group 107 and 15 mcg group 109; and 27, 105 and 103 respectively after the second vaccination.||Days||Standard Deviation|Mean
84785|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination||21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
84786|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination||21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
84787|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
84788|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.In Cohort A, Safety Population after the first vaccination are placebo group 26, 7.5 mcg group 105 and 15 mcg group 96; and 25, 101 and 91 respectively after the second vaccination.||Days||Standard Deviation|Mean
84789|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.||Percentage of participants|||Number
84790|NCT00958243|Primary|Seroconversion Rate 21 Days After Second Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
84813|NCT00958126|Secondary|Frequency and Intensity of Solicited Adverse Events After the First Vaccination|Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.|During the 7 days after the first vaccination|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.||percentage of participants|||Number
87414|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||12 weeks after the first treatment|ITT||Percent change from baseline||Standard Deviation|Mean
84791|NCT00958243|Primary|Seroconversion Rate 21 Days After First Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).||Percentage of participants||95% Confidence Interval|Number
84792|NCT00958217|Primary|Timeline Followback|The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization.|Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months)|||proportion of days abstinent||Standard Deviation|Mean
84793|NCT00958217|Primary|Posttraumatic Stress Disorder (PTSD) Symptoms|The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)|||units on a scale||Standard Deviation|Mean
84794|NCT00958217|Primary|Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.|Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)|||units on a scale||Standard Deviation|Mean
84795|NCT00958191|Secondary|Implant Survivorship||10 years||||||
84796|NCT00958191|Secondary|Lower Extremity Activity Scale (LEAS) Change|Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-operative, 1,3 and 5 years|A total of 240 hips were assessed preoperatively, 215 at 1 year, 152 at 3 years, and 131 at 5 years.||units on a scale|Hips|Standard Deviation|Mean
84797|NCT00958191|Primary|Incidence of Revision of Component for Any Reason|Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.|5 year|Difference of 5 participants from the participant flow completed (=110): 4 participants are included in the revision category of the participant flow and one participant had revision of only the femoral head & stem but later withdrew from the study & is included in the withdrawal category of the participant flow.||percentage of hips undergoing revision|Hips||Number
84798|NCT00958191|Secondary|SF-12 Health Survey Change|Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-operative, 1,3 and 5 years|A total of 233 hips had preoperative SF-12 assessments, 211 had 1 year, 149 had 3 year, and 126 had 5 year SF-12 assessments.||units on a scale|Hips|Standard Deviation|Mean
84799|NCT00958191|Secondary|Harris Hip Score (HHS) Range of Motion (ROM) Change|"The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.~211-300 degrees = 5 points~161 to 210 degrees = 4 points~101 to 160 degrees = 3 points~61 to 100 degrees = 2 points~31 to 60 degrees = 1 points~0 to 30 degrees = 0 points"|pre-operative, 1,3 and 5 years|A total of 240 hips had HHS ROM assessments preoperatively, 211 at the 1 year postoperative interval, 158 at the 3 year postoperative interval, and 122 at the 5 year postoperative interval.||units on a scale|Hips|Standard Deviation|Mean
84840|NCT00957944|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
87415|NCT00933543|Primary|Absolute Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT||lesions||Standard Deviation|Mean
84800|NCT00958191|Secondary|Change in Harris Hip Score (HHS) Pain|"The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.~None or ignores it = 44 points~Slight, occasional, no compromise in activities = 40 points~Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points~Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points~Marked pain, serious limitation of activites = 10 points~Totally disabled, crippled, pain in bed, bedridden = 0 points"|pre-operative, 1,3, and 5 years|A total of 240 hips had HHS Pain assessments preoperatively, 217 at the 1 year postoperative interval, 168 at the 3 year postoperative interval, and 130 at the 5 year postoperative interval.||units on a scale|Hips|Standard Deviation|Mean
84801|NCT00958191|Secondary|Harris Hip Score (HHS) Change|"The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|pre-opearative, 1,3 and 5 years|A total of 236 hips had HHS assessments preoperatively, 211 at the 1 year postoperative interval, 158 at the 3 year postoperative interval, and 121 at the 5 year postoperative interval.||units on a scale|Hips|Standard Deviation|Mean
84802|NCT00958191|Secondary|Radiographic Stability|Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.|1,2,3,4 and 5 years|A total of 214 hips had 1 year radiographs, 195 had 2 year, 166 had 3 year, 153 had 4 year and 137 had 5 year radiographs.||hips evaluated as unstable on radiograph|Hips||Number
84803|NCT00958191|Secondary|Volumetric Wear Rate of the Trident X3 Polyethylene Insert|Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate.|3,4 and 5 years|There were 149 hips with 3 year radiographs, 134 with 4 year, and 118 with 5 year.||cubic mm/year|Hips||Number
84804|NCT00958191|Secondary|Linear Wear Rate of the Trident X3 Polyethylene Insert|Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period.|3 and 4 years|A total of 149 hips were evaluated at 3 years and 134 at 4 years.||mm/year|Hips|Standard Deviation|Mean
84805|NCT00958191|Primary|Mean Linear Wear Rate at 5 Years|Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years|5 years|||mm/year|Hips|Standard Deviation|Mean
84806|NCT00958165|Primary|Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.||12 months|Of the 72 enrolled and treated participants, 67 were evaluable for the chronic effectiveness endpoint.||Successful participants|||Number
84807|NCT00958126|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"Unsolicited adverse event (UAE) grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities."|Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.||percentage of participants|||Number
84808|NCT00958126|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.||percentage of participants|||Number
84809|NCT00958126|Primary|Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
84810|NCT00958126|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
84811|NCT00958126|Primary|Seroconversion Rate 21 Days After the Second Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
87416|NCT00933543|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)||12 weeks after the first treatment|ITT||lesions||Standard Deviation|Mean
84814|NCT00958126|Primary|Seroconversion Rate 21 Days After the First Vaccination|Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
84815|NCT00958074|Secondary|Changes in the Physicians Serial Assessment of Erythroderma Score||Baseline to 30 days post-treatment||||||
84816|NCT00958074|Secondary|Changes in Sezary Cell Count Measured by Serial Flow Cytometry Measurements||Baseline to 30 days post-treatment||||||
84817|NCT00958074|Secondary|Safety and Tolerability of Dose-adjusted Vorinostat|Toxicities will be graded in severity according to the guidelines outlined in the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|Up to 30 days post-treatment||||||
84818|NCT00958074|Secondary|Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);|Assessed by changes in the sum of the products in the greatest diameters of enlarged lymph nodes by serial computed tomography (CT) or positron emission tomography (PET)/CT scans.|Up to 30 days post-treatment||||||
84819|NCT00958074|Primary|Objective Response|Defined as either no evidence of clinical disease or marked improvement (>= 50%) decrease in the modified Severity-Weighted Assessment Tool (mSWAT) skin assessment score compared to baseline.|After at least 14 days. With Confirmation after additional 28 days.|In cohort 1, only 3 of the 4 subjects consented were used for analysis. 1 patient in this cohort only completed 3 days of treatment before removing themselves from treatment and withdrawing consent. This patient was deemed inevaluable, as the timeframe for initial evaluation is 14 days.||percentage of total|||Number
84820|NCT00958035|Primary|Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4|Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).|Month 4|Intent-to-Treat: All randomized subjects||Percentage of Patients|||Number
84821|NCT00958009|Secondary|Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes.|The User Trial Questionnaire was used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, safety and portability of the device. Mean and confidence intervals refer to proportion of subjects responding positively to question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of IMP were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.||Proportion of subjects||95% Confidence Interval|Mean
84822|NCT00958009|Primary|Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire|Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of investigational medicinal product (IMP) were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.||Proportion of subjects||95% Confidence Interval|Mean
84823|NCT00957996|Secondary|Survival (Kaplan-Meier Estimates)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.|14 and 28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||Percent Survival||95% Confidence Interval|Number
84824|NCT00957996|Other Pre-specified|Number of Participants Who Required More Than 5 Days of Peramivir Treatment|The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
84825|NCT00957996|Secondary|Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)|The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||days||95% Confidence Interval|Median
84826|NCT00957996|Secondary|Number of Participants Admitted to ICU After Initiation of Treatment|The number of subjects experiencing ICU admission after initiation of treatment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
84827|NCT00957996|Secondary|Number of Participants Experiencing Influenza-related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
84841|NCT00957944|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Full Range|Median
84828|NCT00957996|Secondary|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||days||95% Confidence Interval|Median
84829|NCT00957996|Secondary|Time to Resumption of Usual Activities|Subject’s ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||hours||95% Confidence Interval|Median
84830|NCT00957996|Secondary|Time to Resolution of Fever|Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||hours||95% Confidence Interval|Median
84831|NCT00957996|Secondary|Time to Alleviation of Symptoms|Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Symptom data for 18 subjects was missing.||hours||95% Confidence Interval|Median
84832|NCT00957996|Secondary|Number of Participants With Clinical Resolution|Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||participants|||Number
84833|NCT00957996|Secondary|Time to Clinical Resolution|Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.||hours||95% Confidence Interval|Median
84834|NCT00957996|Secondary|Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)|The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline, 48, 108, 216 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 41 subjects were excluded due to negative Baseline titers (viral particles/mL RT-PCR value 1.58 for Influenza A and 1.49 for Influenza B).||log10 viral particles/mL||95% Confidence Interval|Median
84835|NCT00957996|Primary|Change From Baseline in Influenza Virus Titer (48 Hours)|The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline and 48 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 83 subjects were excluded due to negative Baseline titers (log10 TCID50 0.5).||log10 TCID50/mL||95% Confidence Interval|Median
84836|NCT00957944|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)||mg||Standard Deviation|Mean
84837|NCT00957944|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||L/h||Standard Deviation|Mean
84838|NCT00957944|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
84839|NCT00957944|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||1/ hour (1/h)||Standard Deviation|Mean
84843|NCT00957944|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)/ mg||Standard Deviation|Mean
84844|NCT00957944|Secondary|AUC(0-∞) Norm (BW)|The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h*kg||Standard Deviation|Mean
84845|NCT00957944|Secondary|AUC(0-∞) Norm (Apparent Dose)|The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
84846|NCT00957944|Secondary|AUC(0-tz) Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h*kg||Standard Deviation|Mean
84847|NCT00957944|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
84848|NCT00957944|Primary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
84849|NCT00957944|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||ng/ mL||Standard Deviation|Mean
84850|NCT00957944|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
84851|NCT00957723|Primary|Implant Survivorship||10 years||||||
84852|NCT00957723|Secondary|Patient Outcome Long Term Follow-up Questionnaire Over Time||6,7,8,9,10 years||||||
84853|NCT00957723|Secondary|Patellar Subluxation, Dislocation and Fracture Rate|The incidence of patellar subluxation, dislocation or fracture is reported.|5 years|Participants with available data.||percentage of knees|knees||Number
84854|NCT00957723|Secondary|Change in Lower-Extremity Activity Scale (LEAS) Over Time|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|preoperative, 1,2,3,4,5 years|Participants with available data: A total of 439 knees had a preoperative LEAS evaluation, 380 had 1 year, 304 had 2 year, 273 had 3 year, 222 had 4 year, and 201 had 5 year LEAS evaluations.||units on a scale|knees|Standard Deviation|Mean
84855|NCT00957723|Secondary|Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|preoperative,1,2,3,4 and 5 years|Participants with available data: Data for the WOMAC is only available at the 2,3,4 and 5 year intervals in limited numbers due to typographical errors noted on earlier interval forms rendering them invalid for comparison. One knee completed the validated WOMAC at 2 & 3 years, 51 at 4 years and 97 at 5 years.||units on a scale|knees|Standard Deviation|Mean
84856|NCT00957723|Secondary|Change in SF-36 Health Survey Over Time|The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|preoperative, 1,2,3,4,5 years|Participants with available data: A total of 433 knees completed a preoperative SF-36 evaluation, 379 completed a 1 year, 303 completed a 2 year, 270 completed a 3 year, 223 completed a 4 year, and 195 completed a 5 year SF-36 evaluation.||units on a scale|knees|Standard Deviation|Mean
84857|NCT00957723|Secondary|Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score|Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms.|1,2,5 years|Participants with available data: A total of 371 knees were assessed radiographically at 1 year, 313 at 2 years, and 199 at 5 years.||Total number of knees|knees||Number
84868|NCT00957658|Secondary|Change in Harris Hip Score (HHS)|The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.|Preoperative, 2 and 5 years|Participants with available data: A total of 195 hips had a preoperative score, 174 had a 2 year score, and 117 had a 5 year score.||units on a scale|Participants|Standard Deviation|Mean
84858|NCT00957723|Secondary|Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)|Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.|1,2,5 years|Participants with available data: A total of 386 knees had 1 year active flexion/extension measurements, 317 had 2 year, and 201 had 5 year active flexion/extension measurements.A total of 385 knees had 1 year passive flexion/extension measurements, 312 had 2 year, and 197 had 5 year passive flexion/extension measurements.||degrees|knees|Standard Deviation|Mean
84859|NCT00957723|Secondary|Change in Knee Society Score (KSS) Over Time|The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|preoperative, 1, 2, 5 years|Participants with available data: For the pain/motion sub-score 415 knees had a preoperative evaluation, 364 had a 1 year, 298 had a 2 year and 190 had a 5 year evaluation. For the function sub-score 440 knees had a preoperative evaluation, 385 had a 1 year, 309 had a 2 year and 203 had a 5 year evaluation.||units on a scale|knees|Standard Deviation|Mean
84860|NCT00957723|Primary|Active Range of Motion||2 Years|Per protocol||Degrees|Knee Implants|Standard Deviation|Mean
84861|NCT00957684|Primary|Part I: Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the intention-to-treat (ITT) population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.to a “frequency per 4 weeks” basis|12-week maintenance period|The primary efficacy analysis was based on the ITT population.||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
84862|NCT00957658|Secondary|Wrist DXA Scan Analysis|DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.|5 years|Participants with available data: 107 hips had DXA scan T-scores at 5 years.||T-score|Participants|Standard Deviation|Mean
84863|NCT00957658|Secondary|Acetabular Insert Wear|The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.|5 years|Participants with available data: 97 hips were evaluated for wear rate at 5 years.||millimeters per year|Participants|Standard Deviation|Mean
84864|NCT00957658|Secondary|PEQ (Patient Evaluation Questionnaire) Percent Achievement|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.~EXPECTATIONS KEY:~Participate in recreational activities (dancing,traveling,gardening)~Exercise or participate in sports~Independently perform household chores/daily routine~Easily change position,sit to stand/stand to sit~Remove need for cane crutch or walker~Use stairs normally step by step~Ability to sleep through night~Maintain social activites,caring for someone,playing with children~Use public transportation or drive~Maintain psychological well-being~Maintain sexual activity~Maintain employment"|6 months, 1 year, 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Participants select 3 expectations and assess percent achievement (100%,75%,50%,25%,or 0%) at 6 mos, 1 yr and 2 yrs.||percentage of participants|Participants||Number
84865|NCT00957658|Secondary|PEQ (Patient Expectation Questionnaire) Overall Satisfaction|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.~EXPECTATIONS KEY:~Participate in recreational activities (dancing,traveling,gardening)~Exercise or participate in sports~Independently perform household chores/daily routine~Easily change position,sit to stand/stand to sit~Remove need for cane crutch or walker~Use stairs normally step by step~Ability to sleep through night~Maintain social activites,caring for someone,playing with children~Use public transportation or drive~Maintain psychological well-being~Maintain sexual activity~Maintain employment"|6 months, 1 year and 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Percentage of participants who were satisfied with the result is reported for each expectation at these intervals.||percentage of particpants|Participants||Number
84866|NCT00957658|Secondary|Change in Lower Extremity Activity Scale (LEAS) Score|The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.|Preoperative, 2 and 5 years|Participants with available data: A total of 231 hips had a preoperative score, 181 had a 2 year, and 129 had a 5 year score.||units on a scale|Participants|Standard Deviation|Mean
84867|NCT00957658|Secondary|Change in SF-12 Score|The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Preoperative, 2 and 5 years|Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores.||units on a scale|Participants|Standard Deviation|Mean
84869|NCT00957658|Secondary|Revision/Removal Rates|The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.|2 and 5 years|Participants with available data: The revision/removal rate of any total hip replacement component at 2 years is reported for 182 hips/176 participants. The revision/removal rate of any component at 5 years is reported for 141 hips/136 participants.||percentage of hips/any component revised|Participants||Number
84870|NCT00957658|Secondary|Percentage (%) of Hip Stems With Aseptic Loosening|Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.|5 years|Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years.||percentage of hips|Participants||Number
84871|NCT00957658|Primary|Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain||2 years|||percentage of hips|Participants||Number
84872|NCT00956761|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0-3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.||Number of participants|||Number
84873|NCT00956761|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.||Percentage of participants||95% Confidence Interval|Number
84874|NCT00956761|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).~The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.||Ratio||95% Confidence Interval|Geometric Mean
84875|NCT00956761|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
84876|NCT00956709|Secondary|Duration of Sensory Sciatic Block (h)||72 hours|||hours||Full Range|Median
84877|NCT00956709|Secondary|Duration of Motor Sciatic Block (h)||72 hours|||hours||Full Range|Median
84878|NCT00956709|Secondary|Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.||72 hours||||||
84879|NCT00956709|Primary|Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot||72 hours|Two patients in each group had incomplete block before surgery.||minutes||Full Range|Median
84880|NCT00956657|Primary|CR Adherence|Number of cardiac rehabilitation classes attended in total.|Approximately 3-months after recruitment|||Classes Attended||Standard Deviation|Mean
84881|NCT00956657|Secondary|Illness Perceptions Questionnaire-Revised Scores|Eight sub-scale scores obtained. Sub-scales include; Illness consequences, Illness Control, Treatment Control, Illness Identity, Emotional Representation, Illness Cause, Illness Coherence, Timeline Cyclical. Minimum and Maximum scores vary for each sub-scale.|3-months after consent||||||
84882|NCT00957593|Secondary|Perinatal Outcomes||24-72 hours||||||
84883|NCT00957593|Primary|Cesarean Delivery|Mode of delivery is the primary outcome|24-72 hours from admission for induction|||Cesarean deliveries|||Number
84884|NCT00957528|Secondary|9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines|Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months|5 months|All subjects who completed the protocol.||pg/mL||Standard Deviation|Mean
84885|NCT00957528|Secondary|Changes in Serum Markers of Bone Turnover.|"Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include:~Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium"|5 months|||nM BCE (Bone Collagen Equivalents)||Standard Error|Mean
84886|NCT00957528|Secondary|Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months|5 months|||gm/cm^2||Standard Error|Mean
84887|NCT00957528|Primary|Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Lean body mass is expressed in grams as calculated by Hologic DEXA.|5 months|All subjects who successfully completed the five month protocol.||grams||Standard Deviation|Mean
87417|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||6 weeks after the first treatment|ITT||percent change from baseline||Standard Deviation|Mean
84888|NCT00957528|Primary|Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months|Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).|5 months|||pounds||Standard Deviation|Mean
84889|NCT00957528|Primary|Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months|The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-[ring-13C6]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = [(EP2 − EP1)/(EM•t)]•60•100, where EP1 and EP2 are the enrichments of bound L-[ring-13C6]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-[ring-13C6]-phenylalanine enrichment in the muscle intracellular pool.|5 Months|Subjects who completed the entire treatment protocol||Percent per hour (%/hr)||Standard Deviation|Mean
84890|NCT00957424|Primary|Number of Participants Willing to Continue With Preferred HRP||1 week follow up|Those who completed one-week multiple product sampling||participants|||Number
84891|NCT00957424|Primary|Number of Participants That Completed 1-week Trial||One week|||participants|||Number
84892|NCT00957424|Primary|Number of Participants Willing to Try HRPs||Baseline|||participants|||Number
84893|NCT00957424|Primary|Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)||Baseline|||participants|||Number
84894|NCT00957372|Primary|PART II: Nº of Treatment-Emergent Adverse Events (TEAE)|The primary objective for Part II of the study was to evaluate the safety and tolerability of eslicarbazepine acetate (ESL, BIA 2-093) at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. Safety assessments were based primarily on AEs (Number of participants with at least one treatment-emergent adverse events are reported); assessment of AEs was based on treatment relatedness, action taken on study drug, outcome, and causality.|1-year|There was no sample size estimate for Part II. Part II was a 1-year open-label extension for patients who had completed Part I and was willing to continue treatment in Part II.||participants|||Number
84895|NCT00957372|Primary|Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on results for the ITT population during the 12-week maintenance period. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA model with treatment as a factor and seizure frequency as a covariate|12 weeks|The primary efficacy analysis was based on the ITT population.The intent-to-treat (ITT) population included all randomized patients with at least one dose of investigational product and at least one post-baseline seizure frequency assessment||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
84896|NCT00957333|Secondary|Urinary Bladder Capacity||1 day||||||
84897|NCT00957333|Primary|Substance Abuse Situation Record|Substance abuse situation record: ketamine|1 day|||years||Full Range|Mean
84898|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||pmol/L||Standard Deviation|Mean
84899|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||hr||Full Range|Median
84900|NCT00957268|Secondary|Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||pmol/L||Standard Deviation|Mean
84901|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||pmol•hr/L||Standard Deviation|Mean
84902|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||Percentage inhibition||Standard Deviation|Mean
84903|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||hr||Full Range|Median
84904|NCT00957268|Secondary|Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||Percentage inhibition||Standard Deviation|Mean
84905|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.||Percentage inhibition•hr||Standard Deviation|Mean
84906|NCT00957268|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.||ng•hr/mL||Standard Deviation|Mean
84907|NCT00957268|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.||hr||Standard Deviation|Mean
84908|NCT00957268|Primary|Cmax: Maximum Observed Plasma Concentration for Alogliptin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.||ng/mL||Standard Deviation|Mean
84909|NCT00957242|Secondary|Fibrin D-dimer Change From Baseline to 16 Weeks|Biomarker that measures biologic activities in patients as opposed to response.|maximum of 48 weeks|||mg/ml||Standard Deviation|Mean
84910|NCT00957242|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks|The DLCO measures the partial pressure difference between inspired and expired carbon monoxide.|Week 48 / Final Visit|||mL/min/mmHg||Standard Deviation|Mean
84911|NCT00957242|Secondary|Total Score St. George's Respiratory Questionnaire (SGRQ)|The SGRQ is a quality of life measurement used to assess respiratory well being with a 0*-100 range (*indicates better health--lower is better).|Week 16 Change from Baseline|All participants per intention-to-treat||score on a scale||Standard Deviation|Mean
84912|NCT00957242|Secondary|Change in 6-minute Walk Distance (6MWD)|The 6MWD is a measure of exercise tolerance. Change in exercise tolerance is calculated at the latest time point (up to 48 weeks) minus the earliest time point (at baseline).|Change from baseline to last visit (maximum of 48 weeks)|||meters||Standard Deviation|Mean
84913|NCT00957242|Secondary|Cardiovascular Mortality or Morbidity|Measured at 48 Weeks|maximum of 48 weeks|||events|||Number
84914|NCT00957242|Secondary|Respiratory-related Hospitalizations||maximum 48 weeks|||events|||Number
84915|NCT00957242|Secondary|Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)||maximum of 48 weeks|||events|||Number
84916|NCT00957242|Secondary|Bleeding Events||maximum of 48 weeks|||events|||Number
84917|NCT00957242|Secondary|All-cause Hospitalizations||maximum 48 weeks|||events|||Number
84918|NCT00957242|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks|Week-16 change from Baseline|16 weeks|||liters||Standard Deviation|Mean
84919|NCT00957242|Secondary|All Cause Mortality||maximum of 48 weeks|All participants per intention-to-treat (ITT)||events|||Number
84920|NCT00957242|Primary|Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity|Death, non-bleeding/non-elective hospitalization, or >10% drop in forced vital capacity.|Events up to 48 weeks|All participants per intention-to-treat (ITT)||events|||Number
84921|NCT00957047|Primary|PART II - Nº of Treatment-Emergent Adverse Events (TEAE)|Safety assessments were based primarily on AEs (Number of patients who experienced at least one AEs), and on whether these were related to the study medication, were serious, led to permanent discontinuation of study participation, or led to death.|1 year|||participants|||Number
84922|NCT00957047|Primary|PART I - Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the ITT population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.|12-week maintenance period|The primary efficacy analysis was an ANCOVA that assessed reduction in seizure frequency per 4 weeks for the ITT population during the 12-week maintenance period||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
84923|NCT00957034|Secondary|Percent Change Physician Global Assessment of Heart Failure Status|Physician rates improvement or deterioration in heart failure: Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
84934|NCT00957021|Primary|Range of Motion|The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.|2 years|Participants can have both knees replaced. Range of motion is measured for each knee, as such the number of knees evaluated can be greater than the number of participants.||degrees|Knees|Standard Deviation|Mean
84935|NCT00957008|Primary|Body Weight|Body weight was assessed using a calibrated balance-beam scale.|nine month|||Kg||Standard Error|Least Squares Mean
84924|NCT00957034|Secondary|Percent Change Patient Global Assessment of Heart Failure Status|Four global questions classifying improvement or deterioration in heart failure - Since your last clinic vist, has there been any change in activity limitation / symptoms / emotions / overall quality of life, related to your heart failure? Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
84925|NCT00957034|Secondary|Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores|Minnesota Living with Heart Failure Questionnaire assessing how much heart failure affects life during previous month. Three scales measuring physical dimension (8 items, score 0-40), emotional dimension (5 items, score 0-25) and overall score (all 21 items, score 0-105). Eight separate items measure social & economic impairments included as part of overall score.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
84926|NCT00957034|Secondary|Mortality or Hospitalizations|Composite endpoint - patients who were hospitalized or died during the trial.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Participants|||Number
84927|NCT00957034|Secondary|Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification|Class I: Cardiac disease w/o limitation of physical activity. Class II: Cardiac disease resulting in slight limitation of physical activity. Comfortable at rest; ordinary activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Cardiac disease resulting in marked limitation of physical activity. Comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. Class IV: Cardiac disease resulting in inability to carry on any physical activity w/o discomfort. Symptoms present at rest. Any physical activity increases discomfort.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change|||Number
84928|NCT00957034|Primary|Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters|Measurement of distance walked as fast as possible on a hard flat pathway in six minutes|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.||Percent Change||95% Confidence Interval|Least Squares Mean
84929|NCT00957021|Secondary|Radiographic Outcome|Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.|1,2 and 5 years|Maximum number of knees evaluable at any interval.||knees|knees||Number
84930|NCT00957021|Secondary|Patient Outcome Lower-Extremity Activity Scale|The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis.|1,2,3,4 and 5 years|Maximum number of knees available at any interval.||units on a scale|knees|Standard Deviation|Mean
84931|NCT00957021|Secondary|Patient Outcome WOMAC|"The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.~Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison."|5 years|The number of knees evaluated at 5 years.||units on a scale|knees|Standard Deviation|Mean
84932|NCT00957021|Secondary|Patient Outcome SF-36|The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state.|1,2,3,4 and 5 years|Maximum number of knees evaluated at any interval.||units on a scale|knees|Standard Deviation|Mean
84933|NCT00957021|Secondary|Patient Outcome Knee Society Score|The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|1,2 and 5 years|Maximum number of knees evaluated at any interval.||units on a scale|knees|Standard Deviation|Mean
84936|NCT00957008|Secondary|Blood Fasting Glucose||Month 9|Last observation carried forward||mg/dl||95% Confidence Interval|Least Squares Mean
84937|NCT00957008|Primary|Body Weight and Waist Circumference||Baseline, Month 4 and Month 9||||||
84942|NCT00956631|Other Pre-specified|Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.|Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes & is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel & how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) & the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, & each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, & shows the broad impact which was of interest in this study.|Baseline and Six Months|All available participants were analyzed at six months.||units on a scale||95% Confidence Interval|Mean
84943|NCT00956631|Other Pre-specified|Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.|Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation)to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).|Baseline and Six months|All available participants at Month 6.||units on a scale||95% Confidence Interval|Mean
84944|NCT00956631|Primary|Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at Month 6.||units on a scale||95% Confidence Interval|Mean
84945|NCT00956592|Secondary|Use of Adjuncts to Assist Intubation||1 year||||||
84946|NCT00956592|Secondary|Laryngeal View Achieved||1 year||||||
84947|NCT00956592|Secondary|Complications||1 year||||||
84948|NCT00956592|Secondary|Rescue Devices Used||1 year||||||
84949|NCT00956592|Secondary|Intubation Time|Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation|1 year||||||
84950|NCT00956592|Primary|Measure of Intubation Success|Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure|During each intubation in a 14 month period|4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study||Participants||95% Confidence Interval|Number
84951|NCT00956540|Primary|Weaning Time|The weaning time starts at the first disconnection from mechanical ventilation lasting >30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.|6 months|||day||Standard Deviation|Mean
84952|NCT00956540|Secondary|Tracheobronchitis and Pneumonia||6 months||||||
84953|NCT00956293|Secondary|Renal Function by Proteinuria||Months12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84954|NCT00956293|Secondary|Renal Function by GFR Over Time||Months 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84955|NCT00956293|Secondary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|Participants with adverse events (serious plus non-serious), serious adverse events and death were reported.|Months 6, 12, 24, 36, 48 and 60|Randomized Safety Set: This set included all randomized participants who received at least one dose of study medication.||Participants|||Number
84956|NCT00956293|Secondary|CD25 Saturation on Lymphocytes||Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84957|NCT00956293|Secondary|Evolution of Renal Function (Creatinine Slope)|The study was terminated prematurely and not powered for efficacy.|Week 7, Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84958|NCT00956293|Secondary|Occurrence of Treatment Failures|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84959|NCT00956293|Secondary|Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84960|NCT00956293|Secondary|Renal Function by Serum Creatinine|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84961|NCT00956293|Secondary|Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84962|NCT00956293|Primary|Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
84963|NCT00956254|Secondary|AUC0-last of Fentanyl|AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic evaluable population: All subjects who had evaluable plasma profiles to calculate reliable estimates of pharmacokinetic parameters and who had no major protocol deviations.||hr*ng/mL||Standard Deviation|Mean
84964|NCT00956254|Secondary|Tmax of Fentanyl|Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.||hr||Standard Deviation|Mean
84965|NCT00956254|Primary|Cmax of Fentanyl|Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.||ng/mL||Standard Deviation|Mean
84966|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks.||% spec.with>5 immature capillaries/HPF|||Number
84967|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks.||% spec.with>5 immature capillaries/HPF|||Number
84968|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks.||% spec.with>5 immature capillaries/HPF|||Number
84969|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks.||% spec.with>5 immature capillaries/HPF|||Number
88377|NCT00926393|Secondary|Number of Patients With Potential Somnolence|Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence|From start of the study treatment to last dose plus 30 days|||Patients|||Number
84970|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week.||% spec.with>5 immature capillaries/HPF|||Number
84971|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes.||% spec.with>5 immature capillaries/HPF|Participants||Number
84972|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 12 weeks after treatment.||%specimen with >25%new collagen/HPF|||Number
84973|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 10 weeks after treatment.||%specimen with >25%new collagen/HPF|||Number
84974|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 6 weeks after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
84975|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 2 weeks after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
84976|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 1 week after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
84977|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 30 minutes after treatment.||%specimen with >25%new collagen/HPF|Participants||Number
84993|NCT00955617|Primary|Overall Image Quality of MRA Images|"Number of images quoted with excellent and more than adequate quality in each group.~Image quality will be assessed on a 5-point scale:~Excellent~More than adequate~Adequate~Less than adequate~Non-diagnostic~Each image is analysed by 4 readers."|MRA examination|descriptive and pilot study, no number of participants calculation performed||Images|Participants||Number
84978|NCT00955955|Secondary|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|"This measure is a 16 item self report questionnaire assessing symptoms of depression. For each item, scores range from 0 to 3 with higher scores indicating greater impairment. To score this measure:~Enter the highest score from questions 1-4 (sleep items): ______~Enter score on item 5 ____~Enter the highest score from questions 6-9 (appetite/weight): ______~Enter score on item 10 ____~Enter score on item 11 ____~Enter score on item 12 ____~Enter score on item 13 ____~Enter score on item 14 ____~Enter the highest score from questions 15-16 (psychomotor items): ______~Total score range 0-27: ______~When assessing changes in this measure over time, negative means indicate an improvement (i.e. the scores decreased over time) and positive means indicate worsening in functioning."|Baseline and Day 60|Data presented is mean score reduction for the QIDS. The dataset of interest is limited to patients treated with placebo in phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone.||Scores on a scale||Standard Deviation|Mean
84979|NCT00955955|Primary|The 17-item Hamilton Depression Scale (HAM-D-17)|"The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68.~When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased)."|Baseline and Day 60|The phase II dataset of interest is limited to patients treated with placebo in phase I, completed phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone. Some patients received Deplin in both phases of the study, but those patients are not included in these analyses.||Scores on a scale||Standard Deviation|Mean
84980|NCT00955916|Secondary|Median Overall Survival (OS)|Overall Survival is defined as the time from randomization until death from any cause.|Up to 3 years|All participants||months||95% Confidence Interval|Median
84981|NCT00955916|Secondary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the duration of time from start of treatment to time of progression. Leukemia related failure (progressive disease): Failure to induce bone marrow hypoplasia after 2 cycles or regrowth of leukemic blasts ≥ 20%.|Up to 3 years|All participants||months||95% Confidence Interval|Median
84982|NCT00955916|Primary|Overall Response Rate (ORR)|Overall Response Rate: Morphologic Complete Remission (CR) + Morphologic Complete Remission with incomplete blood count recovery (CRi) for evaluable participants. CR - Bone Marrow: < 5% blasts without Auer rods with at least 20% cellularity with maturation of all cell lines, No presence of unique phenotype by flow cytometry identical to what was found in the pretreatment specimen, No persistent dysplasia; Peripheral: normal blood counts, absolute neutrophil count (ANC) > 1.0 k/μl and platelets > 100 k/μl ANC > 1.0 k/μl and platelets > 100 k/μl (Peripheral blood counts documenting recovery can be utilized within 4 weeks of the bone marrow); No evidence of extramedullary leukemia. CRi - All CR criteria are met except for residual Neutropenia <1.0 x 10^9/L platelets < 100 k/μl.|8 weeks per participant|All participants||percentage of participants|||Number
84983|NCT00955825|Primary|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient’s daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.~The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).~The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 42.8 days)|The Full Analysis Set (FAS) includes all patients who received at least one dose of the investigational product and had at least one Combined Score while on treatment during the pollen period. The FAS was regarded as primary for the efficacy evaluations.||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
84984|NCT00955747|Primary|Change in Hemoglobin A1C Level From Baseline|The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.|1 year from baseline|Calculation of the final numbers for study completion considers a standard deviation of 1.4%, a two-sided 95% confidence interval (alpha= 0.025), power of 90%, and the ability to detect a 0.5% difference in HbA1c between treatment and placebo groups.||percentage of change from baseline||Standard Error|Least Squares Mean
84985|NCT00955721|Secondary|Phase II: Explore Biomarkers of Response to the Combination||9 Months||||||
84986|NCT00955721|Secondary|Phase II: Further Evaluate the Safety of the Proposed Combination||9 Months||||||
84987|NCT00955721|Secondary|Phase II: Estimate Overall Survival||Start of treatment until death||||||
84988|NCT00955721|Secondary|Phase II: Estimate Overall Response Rate and Clinical Benefit Rate.|Overall response rate [CR + PR]. Clinical Benefit Rate [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)] per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|9 Months|||percentage of patients|||Number
84989|NCT00955721|Primary|Phase II: Obtain an Estimate of the 9-month Progression-free Survival Rate in Patients With Advanced BTC Receiving the RPTD of the Combination Sorafenib and GEMOX.||9 Months|The number or participants is too small to obtain an estimate of the progression-free survival.|||||
84990|NCT00955721|Primary|Phase I: Establish the Recommended Phase II Dose (RPTD) of the Combination of Sorafenib and GEMOX in Patients With Advanced Biliary Tract Cancer (BTC).||First two 14-day Phase I cycles||||||
84991|NCT00955617|Secondary|Signal Intensity|Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.|MRA examination|||Ratio||Standard Deviation|Mean
84992|NCT00955617|Secondary|Diagnostic Confidence|"Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent.~Each image is analysed by 4 readers."|MRA examination|Descriptive study - No calculation||Images|Participants||Number
84996|NCT00955474|Primary|Depression and Psychosis|Depression measured with Hamilton Rating Scale for Depression (HAM-D) at baseline and 8 weeks. Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks.|8 weeks|The study was terminated. Resources were no longer available to analyze the data. PI left the inpatient service where the study was conducted.|||||
84997|NCT00955357|Primary|"The Proportion of Subjects Who Achieved Seizure-free Status During the First 12 Weeks of the Maintenance Phase"|"A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.~This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn."|From Week 7 (end of Week 6) to end of Week 18|The Analysis Population refers to the Completer Set (CS) which includes all subjects who were enrolled, received at least one dose of Lacosamide and completed the first 12 weeks of the Maintenance Phase.||percentage of subjects|||Number
84998|NCT00955305|Secondary|Proportion of Patients With Objective Response|"Objective response was evaluated using the RECIST 1.1 criteria.~Objective response includes complete response (CR) and partial response (PR). Objective response is defined as disappearance of all target lesions or at least a 30% decrease in the sum of the diameters of target lesions. In addition, non-target lesions do not meet the criteria for disease progression and no new lesions were observed."|Assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry; up to 5 years|Eligible and treated patients||Proportion of participants||95% Confidence Interval|Number
84999|NCT00955305|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
85000|NCT00955305|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to progression or death without documentation of progression. For cases without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurs within 3 months following the date last known progression-free, in which case the death was counted as a failure.~Progression was evaluated using RECIST 1.1 criteria and defined as:~At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.~OR~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients||months||95% Confidence Interval|Median
85001|NCT00955279|Secondary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change is calculated as the value at week 28 minus the baseline value.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.||percent of predicted FVC||Standard Error|Least Squares Mean
85002|NCT00955279|Secondary|Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale|The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition.|Week 28|Secondary population included all the participants with chronic sarcoidosis with skin involvement who have received at least 1 dose of study medication.||Percentage of Participants|||Number
85003|NCT00955279|Secondary|Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
85004|NCT00955279|Secondary|Change From Baseline in 6-minute Walk Distance at Week 28|Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.||meters||Standard Error|Least Squares Mean
85005|NCT00955279|Primary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change was calculated as the value at Week 16 minus the baseline value.|Baseline (Day 1) and Week 16|Modified intent-to-treat (mITT) population included all the participants who were randomized and who received at least 1 dose of study medication.||percent of predicted FVC||Standard Error|Least Squares Mean
85018|NCT00954915|Secondary|Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of plaque scale, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 for no psoriasis to a maximum of 72 for severe disease.|Day 0, 14, 28, 63 and 84||||||
85034|NCT00954707|Secondary|Rate of Device Success|A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.|From post- procedure to hospital discharge, up to 39 days|The total number of devices the Intent-to-Treat patients used in the study.||Devices|Participants||Number
85006|NCT00955110|Primary|High VAS - Emax (mm)|"The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar (I am feeling high). The ends of the line were marked with the descriptive anchors (Definitely not and Definitely so). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line."|High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.|Per Protocol population: Subjects who received all 5 treatments and who had no major protocol deviations or other circumstances that would exclude them from the analysis. The pharmacokinetic and pharmacodynamic analyses were performed using the Per Protocol population. No imputation of missing values was performed.||mm||Standard Deviation|Mean
85007|NCT00955032|Secondary|Hamilton Depression Rating Scale (HAM-D)|The Hamilton Depression Rating Scale (HAM-D) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
85008|NCT00955032|Secondary|Beck Depression Inventory-Second Edition (BDI-II)|The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
85009|NCT00955032|Secondary|Lille Apathy Rating Scale (LARS)|The Lille Apathy Rating Scale (LARS) is a 33-item interviewer administered structured questionaire designed to assess level of apathetic symptoms. The first 3 items are scored from -2 to +2, while the remainder items are scored from -1 to +1. Scores can range between -36 to +36. The more positive the score, the greater level of apathy symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
85010|NCT00955032|Primary|Apathy Evaluation Scale (AES)|The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post tx|All participants who completed study procedures were included for analyses.||units on a scale||Standard Deviation|Mean
85011|NCT00954993|Primary|Apparent Terminal Half-life (t-1/2) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the t-1/2 of vaniprevir. The t-1/2 is the time taken to eliminate half the amount of vaniprevir.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Since only a single liver sample timepoint was obtained from each participant at either 6 or 12 hours, and the 24 hour timepoint was not collected from any participant due to the early termination of the study, the t-1/2 could not be determined.|||||
85012|NCT00954993|Primary|Concentration of Vaniprevir in the Liver|Participants were treated with vaniprevir on days, 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were collected at 6, 12, and 24 hours postdose to determine the concentration of vaniprevir in the liver.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Participants treated with vaniprevir who had a liver biopsy were analyzed as two separate groups that received 600 mg and 300 mg doses . No biopsies were collected at the 24 hour timepoint.||nM||Full Range|Median
85013|NCT00954993|Primary|Area Under the Curve (AUC) (0-12 Hrs) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the AUC of vaniprevir. AUC is the integrated area under the curve for plasma concentration of vaniprevir over time.|6, 12 and 24 hours postdose on day 4 of each period (up to Day 148)|Since only a single liver sample timepoint at either 6 or 12 hours was obtained from each participant, and no 24 hour timepoint was collected from any participant due to the early termination of the study, the AUC (0-12 hrs) was not calculated|||||
85014|NCT00954941|Primary|Treatment Success Rate|Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.||percentage of participants|||Number
85015|NCT00954941|Primary|Participant Responses|Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.||participants|||Number
85016|NCT00954915|Secondary|Teplizumab Blood Levels||Day 0 through Day 84||||||
85017|NCT00954915|Secondary|Physician's Global Assessment (PGA)|The PGA rates the subject’s psoriasis relative to baseline as 1 (100% clearing), 2 (excellent: 75% through 99% clearing with striking improvement), 3 (good: 50% through 74% clearing with moderate improvement), 4 (fair: 25% through 49% clearing with slight improvement), 5 (poor: 0% through 24% clearing with little or no change), or 6 (worsening). Involvement of body-surface area, induration, scaling, and erythema are taken into account.|Day 0, 14, 28, 63 and 84||||||
85019|NCT00954915|Secondary|Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)|The LS-PGA score is determined by estimating the extent of body surface area involved by psoriasis and rating plaque qualities (elevation, erythema, scaling) averaged over the entire body. LS-PGA score is then determined using available software. LS-PGA ranks involvement on an 8 point scale from clear, almost clear, mild, mild to moderate, moderate, moderate to severe, severe, and very severe. Participants who have an improvement of one or more steps in the LS-PGA will be considered to have met the primary criteria for a clinical response.|Day 0, 14, 28, 63 and 84||||||
85020|NCT00954915|Primary|Adverse Events (AE)|Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.|Day 0 through Day 84|One subject was enrolled and followed per protocol. This subject's data are described in the adverse events summary.||Participants|||Number
85021|NCT00954824|Primary|The Primary Outcome Measure is Plasma Levels of TNF Alpha.||24 hours|||ng/mL||Standard Deviation|Mean
85022|NCT00954733|Primary|TcCo2 vs PACo2 Difference|Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2|1 hour|||mmHG||Standard Deviation|Mean
85023|NCT00954707|Secondary|Rate of Non-cardiac Death|Include all deaths due to non-cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
85024|NCT00954707|Secondary|Rate of Cardiac Death|Include all deaths due to cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
85025|NCT00954707|Secondary|Rate of Protocol Defined Major Bleeding Complications|Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
85026|NCT00954707|Secondary|Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)|ARC defined ST classifies ST by type – definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
85027|NCT00954707|Secondary|Rate of Protocol Defined Stent Thrombosis (ST)|Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
85028|NCT00954707|Secondary|Rate of Major Adverse Cardiac Events (MACE)|MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).||participants|||Number
85029|NCT00954707|Secondary|Rate of Target Vessel Failure (TVF)|Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).||participants|||Number
85030|NCT00954707|Secondary|Rate of Clinically Driven Target Vessel Revascularization (TVR)|Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.|12 months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).||participants|||Number
85031|NCT00954707|Secondary|Rate of Clinically-driven Target Lesion Revascularization (TVR)|Defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)||participants|||Number
85032|NCT00954707|Secondary|Rate of Procedure Success|Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.|From post- procedure to hospital discharge, up to 39 days|Intent-to-Treat Population||participants|||Number
85033|NCT00954707|Secondary|Rate of Lesion Success|Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.|From post- procedure to hospital discharge, up to 39 days|The total number of lesions the Intent-to-Treat population had at the beginning of the study||Lesions|Participants||Number
85035|NCT00954707|Primary|Phase I: the Rate of Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.|12 months|Active subjects in the ITT population at 12-month post procedure||participants|||Number
85036|NCT00954538|Primary|Least Squares (LS) Mean [18F]MK-3328 SUVR in Brain Posterior Cingulate Gyrus in AD Participants and HE Participants|Using PET brain images acquired after the second dose of [18F]MK-3328, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. Posterior cingulate gyrus SUVR was calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum.|60-90 minutes after second dose|All participants who received a second dose of [18F]MK-3328 in Part III of study||ratio||95% Confidence Interval|Least Squares Mean
85037|NCT00954538|Primary|Mean Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR) in AD Participants and HE Participants|Using PET brain images acquired after dosing, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices).|60-90 minutes post dose|All participants who received [18F]MK-3328 in Part II of study||ratio||Standard Deviation|Mean
85038|NCT00954538|Primary|Organ Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, ROIs were drawn in all organs showing visible [18F]MK-3328 accumulation. TACs showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The organ effective dose is the equivalent dose in each organ multiplied by a weighting factor for the type of tissue exposed. The unit of organ effective dose is Sv.|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study||µSv/MBq||Standard Deviation|Mean
85039|NCT00954538|Primary|Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, regions of interest (ROIs) were drawn in all organs showing visible [18F]MK-3328 accumulation. Time activity curves (TACs) showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA (Organ Level Internal Dose Assessment) software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The total radiation exposure to the body is expressed as the effective dose, which is the sum of the equivalent doses in each organ multiplied by a weighting factor for the type of tissue exposed. Effective dose is the primary surrogate for radiation risk. The unit of effective dose is the Sievert (Sv).|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study||µSv/MBq||Standard Deviation|Mean
85040|NCT00954538|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328||participants|||Number
85041|NCT00954538|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328||participants|||Number
85042|NCT00954512|Primary|Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (safety) consisted of all participants who received ≥1 dose of study drug.||Participants|||Number
85043|NCT00954512|Primary|Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response|Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD).|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (efficacy) consisted of all participants who received ≥1 dose of study drug and were evaluable for this outcome measure.||Participants|||Number
85044|NCT00954447|Other Pre-specified|Number of Patients With HbA1c < 6.5 Percent||24 and 52 weeks|FAS (NCF)||Participants|||Number
85045|NCT00954447|Secondary|Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment||Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner|FAS (OC)||mmol*hr/L||Standard Deviation|Mean
85046|NCT00954447|Secondary|Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment|Mean Daily Glucose was calculated using the 8-point blood glucose profile|Baseline, 24 and 52 weeks|FAS (OC)||mmol*hr/L||Standard Deviation|Mean
85047|NCT00954447|Secondary|Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment|Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)||International units (IU)||Standard Error|Mean
85048|NCT00954447|Secondary|Change From Baseline in FPG||Baseline, 6, 12, 18, 24, 32 and 40 weeks|FAS, observed cases (OC)||mg/dL||Standard Deviation|Mean
85049|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment||Baseline and 52 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement||mg/dL||Standard Deviation|Mean
85050|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment|Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs|Baseline and 24 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement||mg/dL||Standard Error|Mean
85051|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 52|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
85052|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 40|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 40 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
85053|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 32|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 32 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
85054|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 18|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 18 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
85055|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 12|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 12 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
85056|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 6|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 6 weeks|FAS (LOCF)||Percentage||Standard Error|Mean
85057|NCT00954447|Secondary|Number of Patients Lowering HbA1c by at Least 0.5 Percent||24 and 52 weeks|FAS (NCF)||Participants|||Number
85058|NCT00954447|Secondary|Number of Patients With HbA1c < 7.0 Percent||24 and 52 weeks|FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.||Participants|||Number
85059|NCT00954447|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)|Baseline and 24 weeks|The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.||Percentage||Standard Error|Mean
85060|NCT00954421|Secondary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Either VIM or VO On, and for Both VIM and VO Off (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.~Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline).~Either VO or VIM stimulator will be turned on (as opposed to both stimulators, as in outcome measure 1), and change in Tremor Rating Scale scores will be compared. The effects of each individual stimulator will also be compared to both being turned on."|Baseline to Six Months|Patients completing 6 months were tested for VIM and VO both on vs. both off. Score is TRS scale with both off minus both on. Positive value favors DBS.||units on a scale||Standard Deviation|Mean
85061|NCT00954421|Primary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Both VIM and VO ON (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.~Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline)."|Change from Baseline to Six Months|All Subjects completing Period 4||units on a scale||Standard Deviation|Mean
85062|NCT00954356|Secondary|Treatment Emergent Adverse Events|"Adverse Events were recorded at the time of occurence. Clinically significant findings (if any) in ECG and vital signs assessments and laboratory samples were recorded as adverse events.~Treatment Emergent Adverse Events (TEAEs) are those which either started or worsened following administration of study drug (XPF-001 or placebo)."|48 hours|||Events|||Number
85063|NCT00954356|Secondary|Time to Rescue Medication|The time of administration of rescue medication (if any) was recorded for each subject and the duration since dosing was calculated.|24 hours|||Minutes||95% Confidence Interval|Median
85064|NCT00954356|Secondary|Time to Meaningful Relief|"Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).~'Meaningful Relief' was defined as when the relief became 'meaningful' to each individual subject, and was not necessarily a complete absence of pain. 'Meaningful Relief' could not occur before 'First Perceptible Relief'."|24 hours|||Minutes||90% Confidence Interval|Median
85065|NCT00954356|Secondary|Time to First Perceptible Relief|Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).|24 hours|||Minutes||95% Confidence Interval|Median
85066|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID12 is an area calculation encompassing time and the PID scores over the 12 hours following dosing. The minimum possible SPID12 value = -120, the maximum possible = 120.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 12 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
85112|NCT00953706|Secondary|Part B : Rate of Change From Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part B baseline through Week 64|Part B FAS.||percent predicted of FEV1 per 336 days||Standard Error|Least Squares Mean
85067|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID8 is an area calculation encompassing time and the PID scores over the 8 hours following dosing. The minimum possible SPID8 value = -80, the maximum possible = 80.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 8 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
85068|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID6 is an area calculation encompassing time and the PID scores over the 6 hours following dosing. The minimum possible SPID6 value = -60, the maximum possible = 60.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 6 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
85069|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID4 is an area calculation encompassing time and the PID scores over the 4 hours following dosing. The minimum possible SPID4 value = -40, the maximum possible = 40.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 4 hours post dose|||units on a scale||95% Confidence Interval|Least Squares Mean
85070|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 12 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 12-hour observation (TOTPAR 12); TOTPAR 12 is an area calculation incorporating time and relief scores over the 12 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 12 score = 0, maximum possible score = 48."|12 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
85071|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 8 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 8-hour observation (TOTPAR 8); TOTPAR 8 is an area calculation incorporating time and relief scores over the 8 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 8 score = 0, maximum possible score = 32"|8 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
85072|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 4 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 4-hour observation (TOTPAR 4); TOTPAR 4 is an area calculation incorporating time and relief scores over the 4 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 4 score = 0, maximum possible score = 16)."|4 hours|||units on a scale||95% Confidence Interval|Least Squares Mean
85073|NCT00954356|Primary|Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)|"The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 6 score = 0, maximum possible score = 24"|6 hours post dose|Published data from an impacted wisdom tooth removal was used to determine a 60 subject study with 2:1 randomisation and a one-sided significance level of 0.10 would have a power of 84.1%. LOCF was used for imputed values and all subjects were included in both the IIT and PP populations for analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
85074|NCT00954187|Primary|Decreased Overall Pain Score as Measured by the Visual Analogue Scale|No data was collected or analyzed. No study procedures were performed.|one month|No subjects were assigned treatment and no study procedures were performed|||||
85075|NCT00954122|Secondary|Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.|"Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.~Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.~Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14).~This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on Outcome Measurement.||Scores on a scale||Standard Deviation|Mean
85076|NCT00954122|Secondary|Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale|"Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject’s mental. A reduction in score indicates an improvement in the subject’s condition. This assessment is based on the improvement since initiation of the study treatment.~Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-I score.||Scores on a scale||Standard Deviation|Mean
85077|NCT00954122|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)|"Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject’s mental illness. A reduction in score indicates an improvement in the subject’s condition. The CGI-S assessment should be based upon the subject’s symptoms during the previous week.~Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-S score.||scores on a scale||Standard Deviation|Mean
85078|NCT00954122|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Total score.||Scores on a scale||Standard Deviation|Mean
85079|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores|Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Positive score.||Scores on a scale||Standard Deviation|Mean
85080|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.|"Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy.~Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Negative score.||Scores on a scale||Standard Deviation|Mean
85081|NCT00954122|Primary|Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score|PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from ‘absent’ to ‘extremely severe’ (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS-EC score.||Scores on a scale||Standard Deviation|Mean
85082|NCT00954109|Primary|Blood Flow in Response to Oral Glucose Tolerance Tests|Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)|pre and 24 hours post 5-7 days of exercise|||percentage change||Standard Error|Mean
85083|NCT00954109|Primary|Insulin Sensitivity After 5-7 Days of Exercise|Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).|baseline and 24h after 5-7 days of exercise|||index score||Standard Error|Mean
85084|NCT00953927|Secondary|To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.|The number (percentage) of infants with QuantiFERON conversions at any time on the study were summarized by treatment group.|15 to 36 months post-vaccination|Per protocol population who were quantiferon negative at baseline.||participants|||Number
85085|NCT00953927|Secondary|To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.|Investigations for determining correlates of immune protection to TB will not be completed as planned because the study did not show TB protection in MVA85A/AERAS-485 recipients.|15 to 36 months post-vaccination||||||
85086|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the University of Capetown (UCT) Whole Blood Intracellular Cytokine Assay.|Frequencies of CD4 and CD8 T cells expressing cytokines (IFN-γ, IL-2 and TNF-α) following stimulation of whole blood with an Ag85A peptide pool were also measured by flow cytometry for a subset of infants.|28 days post-vaccination|Pre-specified population subset||percentage of cytokine expressing cells||95% Confidence Interval|Median
85113|NCT00953706|Secondary|Part B : Rate of Change From Part A Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part A baseline through Week 64|Part B FAS.||percent predicted of FEV1 per 448 days||Standard Error|Least Squares Mean
85087|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.|An ex vivo IFN-γ ELISPOT assay was used to assess specific T cell responses to an Ag85A peptide pool for a subset of infants.|7 days post-vaccination|Pre-specified population subset||SFC per million PBMCs||95% Confidence Interval|Median
85088|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with an Ag85A peptide pool on a subset of infants.|28 days post-vaccination|Pre-specified population subset||percentage of cytokine expressing cells||95% Confidence Interval|Median
85089|NCT00953927|Secondary|To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.|The number (percentage) of subjects with a diagnosis of tuberculosis based on clinically-derived tuberculosis (TB) diagnostic criteria were summarized by treatment group for all subjects.|15 to 36 months post-vaccination|Per protocol population||participants with a diagnosis of TB|||Number
85090|NCT00953927|Primary|To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.|Adverse events (AE) were collected for 28 days after vaccination. The subject's parent or guardian recorded information regarding occurrences of solicited adverse events in diary cards through 7 days after vaccination. Serious adverse events (SAE) were collected from the time of study vaccine dosing throughout the entire study. A safety cohort (the first 330 infants enrolled) also had serum chemistry and hematology testing up to 28 days post-vaccination.|AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.|All subjects vaccinated.||percentage of all subjects vaccinated||95% Confidence Interval|Number
85091|NCT00953862|Secondary|Change in Clinical Global Impression-- Severity of Illness Score|The CGI-S (Clinical Global Impression-- Severity of Illness) scale is a single-item rating scale of the clinician's assessment of the global severity of ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment||units on a scale||Standard Deviation|Mean
85092|NCT00953862|Secondary|Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score|The ASRS (Adult ADHD Symptom Rating Scale) v1.1 Symptom Checklist is an 18-item scale developed by the workgroup on Adult ADHD for the World Health Organization designed to assess the frequency of ADHD symptoms on a 0-4 scale (0 = never, 1 = rarely, 2 = sometimes, 3= often, and 4 = very often, minimum total summed score of 0 and maximum total summed score of 72, higher score is more impairment).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment||units on a scale||Standard Deviation|Mean
85093|NCT00953862|Primary|Change in Adult ADHD Investigator Symptom Rating Scale Score|The AISRS (Adult ADHD Investigator Symptom Rating Scale) consists 18-items that directly correspond to the 18 DSM-IV symptoms of ADHD. Each item is scored on a 4-point scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe, higher score is more impaired). The total summed score was at minimum 0 and at maximum 54 (the higher the score the more severe the symptomatology).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment||units on a scale||Standard Deviation|Mean
85094|NCT00953849|Primary|Change in IL-6 Levels.|Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
85095|NCT00953849|Primary|Change in GM-CSF|Change in GM-CSF stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
85096|NCT00953849|Primary|Change in IFN-gamma Levels|Change in IFN-gamma stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
85097|NCT00953849|Primary|Change in IL-2 Levels|Change in IL-2 stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.||pg/100 gm protein||Standard Error|Mean
85098|NCT00953719|Secondary|Proportion of Composite Successes|A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.|At final follow-up visit, 24 months or later, up to 72 months|Per Protocol subjects with radiographic endpoints, and including subjects who have been revised (these are composite endpoint failures).||percentage of participants|||Number
85099|NCT00953719|Secondary|Harris Hip Score Longitudinal Analysis|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.|6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively|The population for this endpoint analysis is comprised of subjects who had Harris Hip scores at respective follow-up visits minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
85100|NCT00953719|Secondary|Harris Hip Subscale Score: Range of Motion|The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
85101|NCT00953719|Secondary|Harris Hip Subscale Score: Deformity|The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
85102|NCT00953719|Secondary|Harris Hip Subscale Score: Activities|The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
85103|NCT00953719|Secondary|Harris Hip Subscale Score: Function|The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
85104|NCT00953719|Secondary|Harris Hip Subscale Score: Pain|The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Mean
85105|NCT00953719|Primary|Total Harris Hip Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).|At final follow-up visit, 24 months or later, up to 72 months|The population for this primary endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.||units on a scale||Standard Deviation|Least Squares Mean
85106|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events Per Participant Per Year|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.||events per participant per year|||Number
85107|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.||events|||Number
85108|NCT00953706|Secondary|Part B : Number of Participants With Pulmonary Exacerbations|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.||participants|||Number
85109|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Weight Through Week 64|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms (kg)||Standard Deviation|Mean
85110|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Sweat Chloride Concentration Through Week 64|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||mmol/L||Standard Deviation|Mean
85111|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in CFQ-R Respiratory Domain Score Through Week 64|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
88713|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||μU/μL||Standard Deviation|Mean
85114|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS included all participants who received at least 1 dose of study drug during Part B. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Deviation|Mean
85115|NCT00953706|Secondary|Part A : Rate of Change From Baseline in Weight Through Week 16|As malnutrition is common in participants with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||kilograms per 112 days||Standard Error|Least Squares Mean
85116|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Sweat Chloride Concentration Through Week 16|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
85117|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 16|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||units on a scale||Standard Error|Least Squares Mean
85118|NCT00953706|Primary|Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16|Spirometry (as measured by ppFEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Knudson method.|Part A baseline through Week 16|Part A Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug during Part A. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.||percent predicted of FEV1||Standard Error|Least Squares Mean
85119|NCT00953680|Primary|Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing|30 Hours Post Dose|Pharmacokinetic (PK) results were based on data from the 20 subjects who had blood drawn for the HCTZ assay. These 20 subjects were selected as the first 10 subjects from each treatment sequence who completed both periods of the study.||ng/mL||Standard Deviation|Least Squares Mean
85120|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of HCTZ|Plasma Area Under the Curve, a measure of drug exposure following dosing|0 to 30 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.||ng*hr/mL||Standard Deviation|Least Squares Mean
85121|NCT00953680|Primary|Peak Plasma Concentration (Cmax) for Losartan|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.|36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.||ng/mL||Standard Deviation|Least Squares Mean
85122|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of Losartan||0 to 36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.||ng*hr/mL||Standard Deviation|Least Squares Mean
85123|NCT00953667|Secondary|Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender||Baseline ( −15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of C-Reactive Protein (CRP).||mg/L||Inter-Quartile Range|Median
85124|NCT00953667|Primary|Baseline and Peak TNF-alpha Values as Categorized by Race and Gender||Baseline (−15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of Tumor Necrosis Factor- alpha (TNF-alpha).||pg/ml||Inter-Quartile Range|Median
85125|NCT00953654|Primary|Worry Symptoms|"Worry symptoms, hallmark symptoms of GAD, were assessed using the Penn State Worry Questionnaire (PSWQ). The PSWQ is a 16-item self-report questionnaire that measures pathological worry symptoms. Participants rate items from 1 not at all typical of me to 5 very typical of me. Scores range from 16 to 80, with higher scores indicated exacerbated worry symptoms. Symptoms were assessed at baseline and at the beginning of the second weekly session during weeks 2, 4, and 6."|Baseline, Week 2, Week 4, Week 6|||Units on a scale (PSWQ)|Participants|Standard Deviation|Mean
85126|NCT00953654|Primary|Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings|GAD is characterized by persistent excessive or pathologic worry most days for at least 6 months about activities of daily life that is difficult to control and associated with at least 3 of the following symptoms: restlessness, feeling on edge, being easily fatigued, difficulty concentrating, irritability, muscle tension, and sleep difficulty. Symptoms are not caused by a substance or disorder, but cause significant distress or functional impairment. Remission was measured using the ADIS-IV from 1-16 days following the 6-week intervention.|Pre- and post- 6 week training intervention|||Participants|||Number
88714|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mg/dl||Standard Deviation|Mean
85130|NCT00953615|Primary|Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase|The primary outcome was the change in serum liver biochemical parameter levels after 6 months of thalidomide when compared to baseline values. This was to be analyzed using the nonparametric Wilcoxon signed rank test of significance. This was based on the non-normal distribution of serum hepatic biochemical parameters among patients with PSC and the continuous nature of these variables.|6 months, baseline|Analysis was not performed because participant did not complete the study due to adverse events.||IU/L||Standard Deviation|Mean
85131|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
85132|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
85133|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
85134|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.||Participants|||Number
85135|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.||Participants|||Number
85136|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
85137|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.||Participants|||Number
85138|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.||Participants|||Number
85139|NCT00953407|Primary|Lens Awareness|Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.|4 weeks of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||Participants|||Number
85140|NCT00953329|Primary|Treatment Alefacept|Terminated study|12 weeks (study terminated)|Study terminated|||||
85141|NCT00953290|Primary|Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment|||cm|Participants|Standard Deviation|Mean
85142|NCT00953290|Secondary|Adverse Events||At each visit (treatment and follow-up) or until resolution of AEs|||Event|Participants||Number
85143|NCT00953290|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment|Data was not collected due to termination.||Participants|||Number
85144|NCT00953290|Primary|Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment|||cm|Participants|Standard Deviation|Mean
85145|NCT00953225|Secondary|Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment|Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.|1 year|Each subject had 12 cores measured at each of the pre and post prostate biopsies. The variable summarized is the number of positive cores per subject.||cores per subject||Inter-Quartile Range|Median
85146|NCT00953225|Primary|PSA Slope (Trajectory) or the Change in PSA Level Over Time|Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.|1 year (visits # 1-8)|Linear regression was applied to each subject's data with Log(PSA +1) as the outcome. Based on the fitted model, the change in PSA from visit #1 (baseline) to visit #8 (1 year) was calculated. This derived change score is summarized by group.||ng/mL||Inter-Quartile Range|Median
85147|NCT00953160|Secondary|The Number of Participants With Adverse Events|At each visit (treatment and follow-up) or until resolution of AEs|Up to 6 months after the last treatment|||Participants|||Number
85148|NCT00953160|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment||||||
85149|NCT00953160|Primary|Change in Circumference (cm)||Baseline and 6 months post final treatment|||Centimeters (cm)||Standard Deviation|Mean
85150|NCT00953147|Secondary|Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.|RQLQ(S) scores in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S)consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 26|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85151|NCT00953147|Secondary|Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0|RQLQ(S) scores in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85152|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85153|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population.||units on a scale||Standard Error|Least Squares Mean
85154|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85155|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85156|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85157|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85158|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85159|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all participants analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85160|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85161|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85162|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85163|NCT00953147|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.||units on a scale||Standard Error|Least Squares Mean
85164|NCT00953121|Secondary|Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin|Number of patients experiencing a toxicity greater than or equal to grade 2 treatment-related toxicity|34 months|||participants|||Number
85165|NCT00953121|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|40 months|||months||95% Confidence Interval|Median
85166|NCT00953121|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|40 months|||months||95% Confidence Interval|Median
85167|NCT00953121|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response) based on Response Assessment in Neuro-Oncology (RANO) criteria. A complete response is defined as disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. A partial response is defined as greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.|34 months|The number of participants analyzed is lower than the total number in the study for each arm due to the fact that some patients progressed or experienced an adverse event which resulted in being taken off study during the first cycle and thus were never evaluated for radiographic response.||participants|||Number
85168|NCT00953121|Primary|6 Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.|6 months|||percentage of participants||95% Confidence Interval|Number
85169|NCT00953056|Secondary|Number of Infants With Fecal Vaccine Virus Shedding|Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.|Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo|Only participants in Cohort III, infants that received the scheduled dose of vaccination, and for whom the stool samples were available for testing, were included in the analysis for that dose.||Participants|||Number
85170|NCT00953056|Primary|Number of Serious Adverse Events|The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.|14 days post vaccination|||Events|||Number
85171|NCT00953056|Primary|Number of Participants With Serious Adverse Events|All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.|up to 14 days post vaccination|||Participants|||Number
85172|NCT00953043|Secondary|Median Pressure When Pain Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3|||mm Hg||Full Range|Median
85173|NCT00953043|Secondary|Median Pressure When Gas Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3|||mm Hg||Full Range|Median
85174|NCT00953043|Secondary|Median Pressure When First Sensation Was Reported by 50% of Participants|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3|||mm Hg||Full Range|Median
85175|NCT00953043|Secondary|Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure|Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no gas sensation and 100 mm for extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas sensation.|approximately 1 hour after colonic tube placement, on Day 3|||mm||Standard Error|Mean
85176|NCT00953043|Primary|Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure|Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|approximately 1 hour after colonic tube placement, on Day 3|||mm||Standard Error|Mean
85177|NCT00953043|Primary|Postprandial Colonic Tone|Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after standard meal, on Day 3|||mL||Standard Error|Mean
85178|NCT00953043|Primary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after the colonic tube placement, on Day 3|||mL||Standard Error|Mean
85179|NCT00953043|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.~After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after third dose of lubiprostone or placebo, on Day 3|||mm Hg||Standard Error|Mean
85180|NCT00953017|Secondary|Polyps Detected|Number of polyps|measured at the time of colonoscopy|||polyps|||Number
85181|NCT00953017|Secondary|Procedure Time|total colonoscopy procedure time|measured at the time of colonoscopy|||minutes||Standard Deviation|Mean
85182|NCT00953017|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)|measured at check in to colonoscopy|||units on a scale||Standard Deviation|Mean
85183|NCT00953017|Primary|The Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.|measured at the time of colonoscopy|||Ottawa Scale||Full Range|Mean
85184|NCT00952848|Secondary|Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument|Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days||units on a scale||90% Confidence Interval|Median
85185|NCT00952848|Secondary|Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy|The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention|2 weeks|Patients treated with MC5A devise for 10 consectuvive days||mg/24hr||90% Confidence Interval|Median
85186|NCT00952848|Secondary|Effect of MC5-A on Pain and Neuropathy|Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days||units on a scale||90% Confidence Interval|Median
88715|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mg/dl||Standard Deviation|Mean
85189|NCT00952822|Secondary|Number and Severity of Infusion Site Reactions|Infusion-related local reactions (including pain, tenderness, erythema, induration, and bruising) and severity were evaluated according to an FDA-defined grading scale (FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; 2007).|Within 5 minutes pre-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion||Participants|||Number
85190|NCT00952822|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||IU/dL||Standard Deviation|Geometric Mean
85191|NCT00952822|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||dL/kg||Standard Deviation|Mean
85192|NCT00952822|Secondary|Mean Residence Time|Computed as total area under the moment curve divided by the total AUC. Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||hours (h)||Standard Deviation|Mean
85193|NCT00952822|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||mL/(kg*h)||Standard Deviation|Mean
85194|NCT00952822|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol||hours||Standard Deviation|Mean
85195|NCT00952822|Secondary|Adjusted in Vivo Incremental Recovery|Increase in factor VIII concentration from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Intent to Treat||IU/dL:IU/kg||Standard Deviation|Geometric Mean
85196|NCT00952822|Secondary|Total Area Under the Curve|Total AUC when the concentration is extrapolated to zero using the slope of the β-phase of the model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (intent to treat) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.||IU*h/dL||Standard Deviation|Geometric Mean
85197|NCT00952822|Primary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (per protocol) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.||IU*h/dL||Standard Deviation|Geometric Mean
85198|NCT00952731|Secondary|Difference in Protein S Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between protein S coagulation protein in blood samples collected at baseline and before surgery was measured using an ELISA Kit.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage of protein S in blood||Standard Deviation|Mean
85199|NCT00952731|Secondary|Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor IX coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage of Factor IX protein in blood||Standard Deviation|Mean
85200|NCT00952731|Secondary|Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor VIII coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage Factor VIII protein in blood||Standard Deviation|Mean
85201|NCT00952731|Other Pre-specified|E and Z 4-OHT Isomers|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
85202|NCT00952731|Secondary|Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between vWF coagulation protein in blood samples collected at baseline and before surgery were measured using the immune-turbidimetric assay.|Baseline to immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||percentage of vWF protein in blood||Standard Deviation|Mean
85203|NCT00952731|Secondary|Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery|Hot flashes were assessed by the Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire. This questionnaire measures the incidence of a number of symptoms by asking participants how frequently they experienced them on a scale of 0-4 (0 being Not at All and 4 being Extremely often). BESS questionnaire was administered at baseline and time of surgery. The incidence of vasomotor symptoms (including hot flashes, night sweats, and cold sweats) was measured at baseline (Day 0) and end of treatment prior to surgery (at least 4 weeks later or up to 10 weeks, depending on scheduled surgery date), and changes in the mean score for hot flashes were observed.|Baseline and after 4-10 weeks of treatment|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
85204|NCT00952731|Other Pre-specified|TAM Metabolite Concentrations and Estrogen Response Markers in Nipple Aspiration Fluid (NAF)|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
85205|NCT00952731|Other Pre-specified|4-OHT Affects Known Tamoxifen-modulated Pathways|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
85206|NCT00952731|Other Pre-specified|Drug Metabolite Levels in the Two Study Groups by CYP2D6 Polymorphism Status|Descriptive statistics and confidence intervals will be provided.|28-70 days||||||
85207|NCT00952731|Other Pre-specified|Compare Concentrations of Tamoxifen and Its Metabolites (4-hydroxytamoxifen, Endoxifen, N-desmethyl Tamoxifen (NDT)) Obtained From Samples on the Day of Surgery|Concentrations of tamoxifen and its metabolites: 4-hydroxytamoxifen, endoxifen, and NDT were measured in breast tissue, blood, and Nipple Aspirate Fluid (NAF) that was collected on the day of surgery.|Day of surgery (after approximately 4-10 weeks)||||||
85208|NCT00952731|Primary|Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment|Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).|Baseline and after 4-10 weeks of treatment|18 total subjects were evaluable for immunohistochemistry marker testing including the Ki-67 labeling index. Of the 26 participants who completed study treatment 2 did not have matching samples available for testing and 6 were excluded because of insufficient DCIS lesion in their samples for testing.||percentage of 300 DCIS cells||Standard Deviation|Mean
85209|NCT00952705|Secondary|The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
85210|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
85211|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
85212|NCT00952705|Secondary|The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.||Percentage of Participants|||Number
85213|NCT00952705|Secondary|The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose||Days 0-14 post dose|The Evaluable Safety Population for solicited symptoms included all participants who received any investigational product and had any solicited symptom data available during the reporting period.||Percentage of Participants|||Number
85214|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85215|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85216|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
85217|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
85218|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85219|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85241|NCT00952653|Secondary|Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.||hr||Full Range|Median
88716|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mg/dl||Standard Deviation|Mean
85220|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85221|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
85222|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85223|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1176 and 294, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of subjects|||Number
85224|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586, respectively, received a full dose of investigational product, had post-dose HAI measurement for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85225|NCT00952705|Secondary|The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85226|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85227|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
85228|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
85229|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85230|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85231|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85232|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of participants|||Number
85233|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85234|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1175 and 294 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85235|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.||Percentage of Participants|||Number
85236|NCT00952705|Primary|The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).|Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.|Day 28 to 35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had a post-dose HAI measurement, and had no protocol violation that could have interfered with generation or interpretation of an immune response.||Geometric Mean Titer||Full Range|Geometric Mean
85237|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||hr||Standard Deviation|Mean
85238|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.||hr||Full Range|Median
85239|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
85240|NCT00952653|Secondary|Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||hr||Standard Deviation|Mean
85242|NCT00952653|Secondary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
85243|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
85244|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|1-Hydroxy-Midazolam is an analyte of Midazolam.|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
85245|NCT00952653|Primary|Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.||ng/mL||Standard Deviation|Geometric Mean
85246|NCT00952653|Primary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population: all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.||ng*hr/mL||Standard Deviation|Geometric Mean
85247|NCT00952614|Secondary|Improvement in Macular Edema on Optical Coherence Tomography and Color Photos|Anatomic Change in reading of the size of the area of retinal thickening on color photographs and OCT. Total Macular Volume (TMV) in mm^3, is the calculated volume from the layers of the retina based off OCT imaging.|baseline (preoperatively) to 3 years postoperatively|||improvement in TMV/mm^3||Inter-Quartile Range|Mean
85248|NCT00952614|Primary|Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts|Outcome measure based on eyes at time points with 10-letter ETDRS score improvement|baseline (preoperatively) to 3 years postoperatively|||letters read correctly||Full Range|Mean
85249|NCT00952588|Secondary|Percent of Patients With Worsened Functional Assessment of Cancer Therapy – Leukaemia (FACT-Leu) Score.|The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of “Worsened” was a change from baseline in score of less than or equal to -11.|FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||percentage of participants|||Number
85250|NCT00952588|Secondary|Percent of Patients With Worsened Trial Outcome Index (TOI)|TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of “Worsened” was a change from baseline in score of less than or equal to -9.|TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||percentage of participants|||Number
85251|NCT00952588|Secondary|Overall Survival (OS)|Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive.|Assessed from randomisation until the date of death from any cause, assessed up to 24 months|modified Intent to Treat (mITT)||months||Full Range|Median
85252|NCT00952588|Secondary|Time To Complete Response (TTCR)|TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)|Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||days||Inter-Quartile Range|Median
85253|NCT00952588|Secondary|Disease Free Survival (DFS)|Disease-free Survival is defined as the time from randomisation to relapse or death from any cause.|DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||months||Inter-Quartile Range|Median
85254|NCT00952588|Secondary|Duration of Response (DoR): Stage I and Transition Phase|DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I.|DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)||days||Inter-Quartile Range|Median
85255|NCT00952588|Primary|Percentage of Patients With Overall Complete Response for Stage I|Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to <5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence.|IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (ITT)||percentage of participants|||Number
85256|NCT00952523|Primary|Facial Irritation and Cutaneous Effects|Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.|three weeks|||Scores on a Scale||Standard Deviation|Mean
85257|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose).|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||h*U/L||Standard Deviation|Mean
85258|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax).|Time at maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||hours||Standard Deviation|Mean
85259|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||U/L||Standard Deviation|Mean
85260|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||h*U/L||Standard Deviation|Mean
85261|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||hours||Standard Deviation|Mean
85262|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).||U/L||Standard Deviation|Mean
85263|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Pyridoxal-5’-Phosphate (PLP)|Change from Baseline to Week 24 in Plasma PLP|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||ng/mL||Standard Deviation|Mean
85264|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Plasma Inorganic Pyrophosphate (PPi)|Change from Baseline to Week 24 in Plasma PPi|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||uM||Standard Deviation|Mean
85265|NCT00952484|Secondary|Change in Height (Z-scores)|Change from Baseline to Week 24 in Height Z-Score. Height Z-Scores assigned based on Centers for Disease Control (CDC) growth charts and methodology.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||Height Z score||Standard Deviation|Mean
85266|NCT00952484|Secondary|Change in Osteomalacia - Mineralization Lag Time (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in mineralization lag time.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||days||Standard Deviation|Mean
85267|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Volume/Bone Volume (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid volume/bone volume (%), calculated as the absolute difference of the Baseline and Week 24 percentages.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||percentage points||Standard Deviation|Mean
85268|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Thickness (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid thickness.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.||um||Standard Deviation|Mean
85269|NCT00952484|Primary|Change in Rickets Severity on Skeletal Radiographs From Baseline to Week 24 as Measured by the Radiographic Global Impression of Change (RGI-C) Scale|A 7-point RGI-C (radiographic global impression of change) score was used to rate change in rickets severity. Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings.|Baseline and Week 24|ITT population, which included randomized patients that received treatment with asfotase alfa, even if discontinued or lost to follow-up. The last assessment prior to Week 24 is used for missing Week 24 data; patients with no post-baseline assessments imputed as having no change. A historical control group is used for comparison.||units on a scale||Full Range|Median
85270|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
85271|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
85272|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months|Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
85273|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
85274|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population||Participants|||Number
85275|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population||Participants|||Number
85276|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
85277|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.||Participants|||Number
85278|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population||Participants|||Number
85279|NCT00952393|Primary|Blood Levels of Drug|This is the plasma level of the drug as determined by high performance liquid chromatography.|12 hours|This is all participants in the study.||ng/ml||Standard Deviation|Mean
85280|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).|Day 1|PP||relative risk||Standard Error|Mean
85281|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).|Day 1|PP||relative risk||Standard Error|Mean
85282|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae|Risk factors include age of mother bearing (less than or equal to [<=] 30 years versus [vs] more than [>] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi [RMB], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to [>=] 10000 RMB); whether have brothers or sisters (yes vs no).|Day 1|PP||relative risk||Standard Error|Mean
85283|NCT00952367|Secondary|Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis.||percentage of isolates|||Number
85284|NCT00952367|Secondary|Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B.||percentage of isolates|||Number
85285|NCT00952367|Secondary|Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics|Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae.||percentage of isolates|||Number
85286|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.||percentage of participants|||Number
85287|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.||percentage of participants|||Number
85288|NCT00952367|Primary|Percentage of Participants With Serotypes of Streptococcus Pneumoniae|Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates.||percentage of participants|||Number
85289|NCT00952367|Primary|Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.|Day 1|Per-protocol (PP): Participants who completed collection of nasopharyngeal swab sample, Epidemiology Questionnaire, and 24 hours safety observation. n=number of participants analyzed at that site.||percentage of participants|||Number
85290|NCT00952341|Secondary|Time to First Vomiting Episode in Cycle 1|Time from administration of chemotherapy to first vomiting episode.|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Hours||Standard Error|Mean
85291|NCT00952341|Secondary|Proportion of Participants With No Impact on Daily Life in Cycle 1|"The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
85292|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
85293|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1|Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
85294|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
85295|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1|"Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
85296|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Acute Phase of Cycle 1|"Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
85297|NCT00952341|Primary|Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.||Proportion of participants|||Number
85298|NCT00952289|Secondary|Overall Survival Time at Week 144|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population||probability||95% Confidence Interval|Number
85299|NCT00952289|Secondary|Overall Survival at Week 144|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population||participants|||Number
85300|NCT00952289|Secondary|Overall Survival Time - Extended Data|Overall survival was assessed by the time to death or censoring up until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population||weeks||95% Confidence Interval|Median
85301|NCT00952289|Secondary|Overall Survival - Extended Data|Overall survival is reported here by the number of deaths from randomization until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population||participants|||Number
85302|NCT00952289|Secondary|Overall Survival Time|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population||weeks||95% Confidence Interval|Median
85303|NCT00952289|Secondary|Overall Survival|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population||participants|||Number
85304|NCT00952289|Secondary|Change From Baseline to Week 24 in Total Symptom Score|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|This analysis only includes patients who had a non-missing change from Baseline to Week 24. Data collected after the date of treatment cross over were not included in this analysis.||scores on a scale||Standard Deviation|Mean
85305|NCT00952289|Secondary|Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|ITT evaluable population included patients with Baseline data and who did not have a 0 total score at both Baseline & Week 24; data measured after the cross over date were excluded. Patients who withdrew, met cross over criteria prior to Week 24 or had a 0 Baseline score & a nonzero/missing score at Week 24 were considered not meeting the endpoint.||participants|||Number
85306|NCT00952289|Secondary|Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The duration of ≥ 35% reduction from Baseline in spleen volume was defined as the longest duration of consecutive measurements of ≥ 35% reduction observed before the data cut-off date for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or, who subsequently dropped out prior to another assessment. The duration of a ≥ 35% reduction from Baseline in spleen volume was analyzed using the Kaplan-Meier method.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.||weeks||95% Confidence Interval|Median
85307|NCT00952289|Secondary|Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The maintenance of ≥ 35% reduction from Baseline in spleen volume was assessed up until the data cutoff date using the Kaplan-Meier method for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or who subsequently dropped out prior to another assessment.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.||proportion of participants||95% Confidence Interval|Number
85308|NCT00952289|Primary|Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24|Spleen volume was assessed by magnetic resonance imaging (MRI) or by computed tomography (CT) scans if MRI was not suitable, and analyzed by a blinded central laboratory reader. Patients who withdrew, crossed over to ruxolitinib prior to the visit, or had a missing value at the visit were considered non-responders.|Baseline and Week 24|Intent-to-treat (ITT) population included all subjects randomized in the study. Treatment groups for this population were defined according to the treatment assignment at randomization. One patient was not included in the analysis due to a missing baseline spleen volume value.||participants|||Number
85324|NCT00952068|Secondary|Number of Participants With Adverse Events|All adverse events reported during treatment with study drug were considered and reported as treatment emergent adverse events (TEAE) whether or not medication for this adverse event was required by the participant and were summarized in the same table.|6 hours|Safety population: includes all patients who received the dose of the study medication.||participants|||Number
85309|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older.||Participants|||Number
85310|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years.||Participants|||Number
85311|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.||Titers||95% Confidence Interval|Geometric Mean
85312|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.||Participants|||Number
85313|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.||Participants|||Number
85314|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.||Titers||95% Confidence Interval|Geometric Mean
85315|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.||Participants|||Number
85316|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.||Participants|||Number
85317|NCT00952211|Secondary|Hospital Anxiety and Depression (HADS) Scale -Depression Subscale|HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms|10 days after beginning CPAP treatment|||units on a scale||Standard Deviation|Mean
85318|NCT00952211|Primary|Profile of Mood States (POMS) - Fatigue Subscale|POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue|10 days after beginning CPAP treatment|Data only available for 2 subjects; one subject did not provide data for this questionnaire.||units on a scale||Standard Deviation|Mean
85319|NCT00952133|Secondary|Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery|Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery.|Pre-op through 96 hours post-op|||participants|||Number
85320|NCT00952133|Primary|Complete Response Rate|A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.|Pre-op through 72 hours post emergence from anesthesia|||participants|||Number
85321|NCT00952120|Secondary|Percentage of Wounds With Total Skin Graft Loss|For each wound, whether there was total skin graft loss by Day 4 or 5 was determined.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables)||percentage of wounds|Participants||Number
85322|NCT00952120|Primary|Percentage of Wounds With Complete Skin Graft Take|For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables).||percentage of wounds|Participants||Number
85323|NCT00952081|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control)||intraoperatively and 90 min after surgery|||participants|||Number
85345|NCT00951899|Secondary|Rate of Meal Glucose Disappearance (Meal Rd)|Meal Rd is the rate at which glucose leaves the systemic circulation. It was measured using a triple-tracer mixed meal and reported in micromols over 6 hours. Meal Rd was calculated by subtracting the change in glucose mass from the overall rate of glucose appearance (i.e., meal Ra + EGP).|Baseline, 12 Weeks|||micromol/6h||Standard Error|Mean
85325|NCT00952068|Secondary|Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose|PK samples were drawn at the end of the Screening Phase, at the onset of perceptible pain relief, at 3 hours and at 6 hours post-dose or if the patient discontinues early. PK samples were always drawn after the completion of the patient ratings of pain relief and of pain intensity scales. They were processed in a central laboratory and the plasma levels of tramadol were collected.|Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||ng/ml||Standard Deviation|Mean
85326|NCT00952068|Secondary|Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain relief rating at time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier.  How would you rate the pain relief the study medication has given you? ranging from 0=none to 4=complete relief. Missing data were imputed using Last Observation Carried Forward (LOCF)."|3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||participants|||Number
85327|NCT00952068|Secondary|Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain intensity rating at baseline, time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. What is your current level of pain intensity? 0=none, 1=mild, 2=moderate, 3=severe. Missing data were imputed using Last Observation Carried Forward (LOCF)."|Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||participants|||Number
85328|NCT00952068|Primary|Time to Onset of Perceptible Pain Relief|Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.|6 hours|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.||minutes||95% Confidence Interval|Median
85329|NCT00951912|Secondary|Total Energy Intake at Follow-up|The energy intake was evaluated by 3 days dietary records.|an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.|The number of participants for analysis was determinted by intention to treat||kcal||Standard Deviation|Mean
85330|NCT00951912|Secondary|Urinary Genistein|Urinary genistein excretion|3 months|The number of participants for analysis was determinted by the number of participants who supplied the urine samples at the 3-month test||ug/ml||Standard Deviation|Geometric Mean
85331|NCT00951912|Secondary|Urinary Daidzein|Urinary daidzein excretion|3 months|The number of participants for analysis was determinted by the number of participants who provided urine samples at the 3-month test||ug/ml||Standard Deviation|Geometric Mean
85332|NCT00951912|Secondary|Total Urinary Isoflavones||3 months|The number of participants for analysis was determinted by the participants who provided the urine samples at the 3-month test.||ug/ml||Standard Deviation|Geometric Mean
85333|NCT00951912|Primary|Percentage Change in Low Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
85334|NCT00951912|Primary|Percentage Change in High Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|||Percentage of change||Standard Deviation|Mean
85335|NCT00951912|Primary|Percentage Change in Triglyceride|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
85336|NCT00951912|Primary|Percentage Change in Total Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
85337|NCT00951912|Primary|Percentage Change in QUICKI|"QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter.~The percentage change was caculated as (6th month value-baseline value)/baseline value*100%"|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
85338|NCT00951912|Primary|Percentage Change in HOMA-IR|HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat||Percentage of change||Standard Deviation|Mean
85339|NCT00951912|Primary|Percentage Change in Fasting Plasma Insulin|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants was determinted by intention to treat||percentage of change||Standard Deviation|Mean
85340|NCT00951912|Primary|Percentage Change in AUC of Glucose|values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of patticipants was determinted by intention to treat||percentage of change||Standard Deviation|Mean
85341|NCT00951912|Primary|Percentage Change in HbA1C|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants analyzed was determinted by intention to treat.||percentage of change||Standard Deviation|Mean
85342|NCT00951912|Primary|Percentage Change in 120-minutes Postload Plasma Glucose|(6th month value-baseline value)/baseline*100%|Baseline, 6 months|All participants were determinted by intention to treat||percentage of change||Standard Deviation|Mean
85343|NCT00951912|Primary|Percentage Change in Fasting Plasma Glucose|(6th month value-baseline value)/baseline value*100%|Baseline,6 months|the number of participants for analysis was determined by intention to treat||percentage of change||Standard Deviation|Mean
85344|NCT00951899|Secondary|Lipid Values|Lipids are fat-like substances in the blood.|Baseline, 12 weeks|||mmol/l||Standard Error|Mean
85346|NCT00951899|Secondary|Rate of Meal Glucose Appearance (Meal Ra)|Meal Ra was measured using a triple-tracer mixed meal and reported in micromols in 6 hours. Meal derived glucose is a function of both gastric emptying and splanchnic meal extraction. Meal Ra was calculated by multiplying rate of appearance of [1-^13C] glucose (obtained from the infusion rate of [6-^3H] glucose and the clamped plasma ratio of [6-^3H] glucose and [1-^13C] glucose) by the meal enrichment.|Baseline, 12 Weeks|||micromol/6h||Standard Error|Mean
85347|NCT00951899|Secondary|Fasting Endogenous Glucose Production (EGP)|EGP was measured using a triple-tracer mixed meal and calculated using the Steele's model, reported in micromoles per kilogram per minute.|Baseline, 12 Weeks|||micromol/kg/min||Standard Error|Mean
85348|NCT00951899|Secondary|Insulin Concentration|Fasting insulin levels were measured in the plasma using a chemiluminescence assay and is reported in nanomoles over 6 hours.|Baseline, 12 Weeks|||nmols/6 hrs||Standard Error|Mean
85349|NCT00951899|Secondary|Glycosylated Hemoglobin (HbA1c)|HbA1c is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.|Baseline, 12 weeks|||Percentage of hemoglobin||Standard Error|Mean
85350|NCT00951899|Secondary|Plasma Glucose Concentration|Fasting glucose concentrations were measured at baseline and 2 hours post-meal using the glucose oxidase method.|Baseline, 12 Weeks|||mmol/L||Standard Error|Mean
85351|NCT00951899|Secondary|Total Fasting Glucagon-Like Peptide-1 (GLP-1) Concentration|GLP-1 is thought to increase insulin secretion and was measured in the blood and reported in picomoles per liter.|Baseline, 12 weeks|||pmol/L||Standard Error|Mean
85352|NCT00951899|Primary|Total Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|Baseline, 12 weeks|Intent to treat analysis population.||DItot (10^-14 dl/kg/min^2 per pmol/l)||Standard Error|Mean
85353|NCT00951821|Secondary|Beck Suicide Scale - Adolescent Response|measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation. These data refer to adolescent respondents. The outcome is a change score so range is from -38 to 38.|Measured at 12 months|intent to treat||units on a scale||Standard Error|Mean
85354|NCT00951821|Primary|Beck Depression Inventory - Adolescent Report, Change in Symptom Level|self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression. The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.|12 months|intent to treat||change in BDI (-60 to 60 possible range)||Standard Error|Mean
85355|NCT00951808|Primary|Acute Chest Syndrome|First occurence of positive infiltrate on chest x-ray|Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.|Of 237 enrolled subjects, 27 subjects who received a transfusion and 7 subjects who had insufficient sPLA2 measurements were excluded. Therefore, two hundred and three (203) subjects were included in the analysis. Results were not reported by Arm due to the lack of enrollment.||participants|||Number
85356|NCT00951665|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the first day of study treatment to documented disease progression or death on study i.e., death due to any cause within 30-days of last dose of study treatment, whichever occurs first.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.||months||Full Range|Median
85357|NCT00951665|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR, PR, or stable disease (SD) of 6 months or more duration as assessed by the investigator. CR and PR are identified in previous outcome measure. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.||percentage of participants|||Number
85358|NCT00951665|Secondary|Duration of Objective Response|Duration of OR is only calculated for participants with OR and is defined as the time from the first tumor assessment that supports the participant`s OR to disease progression or death.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with OR were considered for this outcome measure.||months||95% Confidence Interval|Median
85359|NCT00951665|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Participants with measurable disease (at least one lesion 2 centimeters [cm] or more on computed tomography (CT) scan or 1 cm or more on spiral CT scan) were considered for OR. ORR is defined as the percentage of patients with a complete response (CR)/partial response (PR) determined on two consecutive tumor assessments at least 4 weeks apart based on modified Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST). CR defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR defined as at least 30 percent decrease in sum of the longest diameters of the target lesions taking as reference the baseline sum longest diameters.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with measurable disease were considered for OR.||percentage of participants|||Number
85466|NCT00950937|Secondary|Neutrophil Count|Neutrophil count at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||Cell/ul of blood||Inter-Quartile Range|Median
85360|NCT00951665|Primary|Number of Participants With Change From Baseline in Cardiac Function|Change in cardiac functions i.e., left ventricular ejection fraction (LVEF) and segmental wall abnormalities were assessed by echocardiogram or multigated acquisition scans. LVEF was assessed as change from baseline as 0 to <15%, >=15 to <25%, >=25%, and missing values.|Baseline (30 days prior to study dose), end of Cycle 2, and then every three cycles in Phase Ib and every four cycles in Phase IIa throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|Safety Population: All participants who received at least a single dose of study medication were included.||participants|||Number
85361|NCT00951665|Primary|An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-inf]) X (AUMC[0-inf])/AUC[0-inf]) where D is the dose of study drug, AUMC(0-inf) is the area under the first moment curve extrapolated to infinity and AUC(0-inf) is the area under the plasma concentration-time curve from time zero to infinite time. The Vss of paclitaxel (65 mg/m2 and 80 mg/m2) is observed in Cycle 1 (in the absence of T-DM1) and Cycle 2 (in the presence of T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||L/m^2||Standard Deviation|Mean
85362|NCT00951665|Primary|Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma CL of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis for in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||L/hr/m^2||Standard Deviation|Mean
85363|NCT00951665|Primary|An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma t1/2 of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||hr||Standard Deviation|Mean
85364|NCT00951665|Primary|Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma AUC0-inf of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||hr*ng/mL||Standard Deviation|Mean
85365|NCT00951665|Primary|Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)|Plasma Cmax of paclitaxel (65 mg/m^2 and 80 mg/m^2) for Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1) was estimated by non-compartmental analysis.|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.||ng/mL||Standard Deviation|Mean
85366|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUClast) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|AUClast for serum T-DM1 and serum total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||day*µg/mL||Standard Deviation|Mean
85367|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After QW Dose Regimen|Cmax for plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1, and Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||ng/mL||Full Range|Mean
85368|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|Cmax for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis when T-DM1 was administered QW.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||mcg/mL||Standard Deviation|Mean
85369|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUC0-Day 21) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|AUC0-21 for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre- and post-dose (0.25 and 4 hours and Day 8 [before paclitaxel infusion) for Cycle 1 and pre- and post-dose (0.25 and 4 hours) for Cycle 2 (each cycle of 21 days)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||day*mcg/mL||Standard Deviation|Mean
88717|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mg/dl||Standard Deviation|Mean
85370|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After Q3W Dose Regimen|Cmax of plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||nano gram per milliliter (ng/mL)||Full Range|Mean
85371|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|Cmax of serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|Pharmacokinetics (PK) population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.||microgram per millilitre (Mcg /mL)||Standard Deviation|Mean
85372|NCT00951665|Primary|Number of Participants Who Had Adverse Events That Required Dose Modification of T-DM1 or Paclitaxel|Participants were assessed for toxicity prior to each dose of T-DM1 and paclitaxel; dosing occurred only if the clinical assessment and laboratory test values were acceptable. Dose modifications included dose delayed or any dose reduction. Participants in whom significant toxicities had not recovered to the treatment range defined by the dose modification guidelines at the time of their next scheduled dose, had their dose of T-DM1 and/or paclitaxel delayed or reduced for up to 21 days.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.||participants|||Number
85373|NCT00951665|Primary|Number of Participants in Phase IIa of the Study Who Received 12 or More Paclitaxel Doses in Combination With T-DM1 and/or Pertuzumab|Participants in Phase IIa received T-DM1 Q3W and paclitaxel in Group A and T-DM1, paclitaxel, and pertuzumab in Group B.|From Day 1 to 15 weeks|Safety Population: All participants of the phase IIa part of the study who received at least a single dose of study medication and did not have disease progression in the first 12 weeks of study treatment were included.||participants|||Number
85374|NCT00951665|Primary|Maximum Tolerated Dose of Paclitaxel When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when paclitaxel (QW) and T-DM1 (Q3W or QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.||mg/m^2|||Number
85375|NCT00951665|Primary|Maximum Tolerated Dose of T-DM1 When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of T-DM1 and paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when T-DM1 (Q3W or QW) and paclitaxel (QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.||mg/kg|||Number
85376|NCT00951665|Primary|Number of Participants With Dose Limiting Toxicity (DLT) of the Combination of T-DM1 and Paclitaxel When T-DM1 Was Administered on Either an Q3W or QW Schedule for Both With and Without Pertuzumab Treatment|DLT is defined as one of the following toxicities related to study drug during Cycle 1, according to the NCI CTCAE, Version 3: Grade 3 or higher non-hematologic AEs; Grade 3 or higher elevation of serum bilirubin, hepatic transaminases, or alkaline phosphatase; Grade 4 or higher thrombocytopenia; Grade 4 or higher neutropenia; any subjectively intolerable toxicity related to T-DM1, paclitaxel, or pertuzumab; any treatment-related toxicity prohibiting the start of the second cycle of treatment and/or prompting to a dose delay or modification during the DLT observation period, such as prompting a dose reduction at Cycle 2 Day1.|Up to 23 days|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included. Participants in Phase 1b (Regimen 1, Regimen 2, Regimen 3 and Regimen 4 [60 participants]) were considered for this analysis.||participants|||Number
85377|NCT00951665|Primary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.||participants|||Number
85378|NCT00951561|Primary|Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model|Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.|1 month, 2 months, 3 months, 4 months|Statistical analysis was carried out per plan.||percentage of uses|Participants||Number
85379|NCT00951509|Primary|Composite Power Mobility Road Test (PMRT) Scores|The computer-based and the virtual environments will be modeled after and scored similarly to the real world PMRT. The PMRT contains two domains: Structured Elements/Tasks and Unstructured Skilled Driving. The first domains contain 16 tasks that include activities such as passing through standard width doorways, and turning a ninety-degree turn, turning 180 degrees. In both domains, each task is scored from 1 to 4, depending on speed and the number of collisions that occur with obstacles. A total score for the entire test is calculated out of a possible 64 points, and the final score on the test reflects the percentage of total points acquired1. A passing score is a percentage of > 95%.|Baseline in-lab testing|Majority of the participants (41%) had a spectrum of multiple disabilities ranging from stroke, spinal stenosis, osteoarthritis, emphysema, and cerebral degeneration, followed by 11 participants (35%) with spinal cord injury.||units on a scale||Standard Error|Mean
88718|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mg/dl||Standard Deviation|Mean
85380|NCT00951483|Secondary|Change in 14-item Perceived Stress Scale (PSS-14)|The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress.|Baseline and 12 weeks|This analysis is restricted to the twenty-three individuals from the intervention cohort had valid PSS-14 responses at baseline and 12 weeks; the healthy control arm is not included, because their PSS-14 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
85381|NCT00951483|Secondary|Change in Beck Depression Inventory (BDI)|The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-seven individuals from the intervention cohort had valid BDI responses at baseline and 12 weeks; the healthy control arm is not included, because their BDI scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
85382|NCT00951483|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-A responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-A scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
85383|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)|The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-D-21 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-21 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
85384|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)|The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-17 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-17 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
85385|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)|The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-7 responses at baseline and 12 weeks; the healthy control arm is not included here, because their HAM-D-7 scores were recorded at baseline only (see baseline characteristics).||units on a scale||Inter-Quartile Range|Median
85386|NCT00951483|Primary|C-Reactive Protein at 12 Weeks|To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.|12 weeks|Due to the cost for the C-reactive protein assay, only 20 individuals from each cohort are analyzed (N = 40).||mg/L||Inter-Quartile Range|Median
85387|NCT00951379|Primary|Dichotomized Clinical Response: Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|Clinical Response assessed according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. Complete Response (CR): Disappearance of all evidence of target AND non-target lesions. Partial Response (PR): greater than or equal to 50% reduction in the sum of the products of diameters of all target lesion(s). Non-target lesions may not increase greater than or equal 25% in size and no new lesion may appear. No Change (NC): No change in the size of the lesion(s) and no new lesions appearing, i.e. anything that is not CR, PR or PD. Progressive Disease (PD): Any increase greater than or equal to 25% in the product of the diameters of any measurable lesions or in the estimated size of non-measurable lesions or the appearance of an unequivocal new lesion.|Response assessed at Week 24 ±1 Week|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
85388|NCT00951379|Primary|Dichotomized Histologic Response (HR): Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|HR according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. CR: Complete reversal dysplasia/hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree dysplasia/hyperplasia in all biopsied lesion from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable. No Change (NC): No change in degree dysplasia/hyperplasia in all biopsied lesions, anything not CR, PR or PD. Progressive Disease (PD): Any increase in severity histology grade any biopsied lesion. Early premalignant lesion: lesion defined high risk, indicated by presence of one: hyperplasia at high-risk sites (dorsal, lateral or ventral tongue, or floor of mouth) ONLY, or mild dysplasia. Advanced premalignant lesion: lesion with presence of one: moderate dysplasia or severe dysplasia (excluding CIS), erythroplakia with hyperplasia or of any severity of dysplasia.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
85407|NCT00951275|Secondary|Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||days||Standard Deviation|Mean
85389|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of PPARG Nucleus and PPARG Cytoplasm|Tissue levels of Peroxisome proliferator-activated receptor gamma (PPARG) Nucleus and PPARG Cytoplasm as indirect measures of pharmacological effect, PPAR gamma assessed by immunohistochemistry. Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed at end of study, and two participants in Placebo were not analyzed for PPARG baseline scores. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
85390|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of B-cell Lymphoma 2 (Bcl2)|Tissue levels of Bcl2 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported a percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants of 25 overall in the Pioglitazone arm were not analyzed for Bcl2 end of study score and one participant in Placebo was not analyzed for Bcl2 baseline score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
85391|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of p21|Tissue levels of p21 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for p21 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
85392|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Ki-67|Tissue levels of Ki-67 for proliferation assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed for Ki-67 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
85393|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Cyclin D1|Tissue levels of Cyclin D1 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for Cyclin D1 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.||percentage of staining cells positive||Standard Deviation|Mean
85394|NCT00951379|Secondary|Number of Participants Affected by Adverse Events Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0)|All adverse events (including serious) and clinical laboratory toxicity summarized affected organ system. Reporting based on the NCI CTCAE v4.0 by treatment, details included in later Adverse Event Module of results.|Up to 26 weeks|Population includes all enrolled participants.||participants|||Number
85395|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Alcohol Use|Alcohol use will be summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical and pathological response assessed using statistical regression models in an exploratory fashion. Heavy drinkers are participants who drank every day; Light drinkers are participants who drank on some days; Non-drinkers are former drinkers or those who never drank alcohol.|Up to 26 weeks|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
85396|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Tobacco Use|Tobacco use summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical response assessed.|Up to 26 weeks|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
85397|NCT00951379|Secondary|Number of Participants With Level of C-reactive Protein in Plasma Decrease From >5.0 mg/L to <= 5.0 mg/L From Baseline to End of Study|The longitudinal regression models for analysis of the change in CRP in plasma will be used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates.|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 20 evaluable specimens at baseline & 20 at end of study with 2 of those not available for the CRP>5 baseline measure & Placebo's 25 had 25 evaluable at baseline & 21 evaluable at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participants needed 1/+ dose of treatment.||participants|||Number
85398|NCT00951379|Secondary|Number of Participants With >5.0 mg/L in Level of C-reactive Protein in Plasma|"Degree of change of C-reactive protein (CRP) in plasma serum via blood tests.~The longitudinal regression models for analysis of the change in CRP in plasma used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates."|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 24 evaluable specimens at baseline & 20 evaluable at end of study with 2 of those not available for CRP>5 baseline measure: Placebo's 25 had 25 evaluable specimens at baseline & 21 at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participant needed 1/+ dose of treatment.||participants|||Number
85399|NCT00951379|Primary|Overall Response <Clinical and Histologic Response Defined as 50% or Greater Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia>|Overall Dichotomized Clinical and Histologic Response defined as 50% or greater reduction in sum of the measured products of perpendicular dimensions of the target lesion(s) or improvement in the degree of dysplasia or hyperplasia where complete (CR) or partial response (PR) in either clinical or histologic outcome assessed according to criteria given recorded as Response or No Response and analyzed as a dichotomous variable. Clinical Response = CR: Disappearance all evidence target & non-target lesions; PR: >/=50% reduction in sum products of diameters all target lesion(s). Non-target lesions may not increase >/=25% in size & no new lesion. Histologic Response = CR: Complete reversal of dysplasia or hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree of dysplasia or hyperplasia in all biopsied lesion(s) from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.||participants|||Number
85400|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
85401|NCT00951275|Secondary|Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
85402|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score|"Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement."|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
85403|NCT00951275|Secondary|SF-HLQ Hindrance Score|"Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score)."|Baseline|ITT population; n=number of participants assessed for the specified parameter.||units on a scale||Standard Deviation|Mean
85404|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||hours||Standard Deviation|Mean
85405|NCT00951275|Secondary|Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.||hours||Standard Deviation|Mean
85406|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter.||days||Standard Deviation|Mean
85408|NCT00951275|Secondary|Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin||Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
85409|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in DAS28 Score|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population||percent change from baseline||Standard Deviation|Mean
85410|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by DAS28 Category|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
85411|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (<)3.2 and improvement from baseline of >1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of >5.1 and improvement from baseline of >1.2; No response was defined as a DAS28 score of >5.1 and improvement from baseline of <1.2. Participants who discontinued prematurely were identified as non-responders.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
85412|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in ESR|ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr.|Week 24|ITT population||percent change in mm/hr||Standard Deviation|Mean
85413|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)|hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L).|Week 24|ITT population||percent change in mg/L||Standard Deviation|Mean
85414|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in HAQ-DI|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Week 24|ITT population||percent change from baseline||Standard Deviation|Mean
85415|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity|The physician’s assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme was considered “maximum disease activity”. The physician’s global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded.|Week 24|ITT population||percent change in mm||Standard Deviation|Mean
85416|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity|The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as “no disease activity” (symptom free and no arthritis symptoms) and the right-hand extreme as “maximum disease activity” (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded.|Week 24|ITT population||percent change in mm||Standard Deviation|Mean
85417|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain|The participant’s assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as “no pain” and the right-hand as “unbearable pain”. The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded.|Week 24|ITT population||percent change in mm||Standard Deviation|Mean
85418|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in SJC|Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population||percent change in swollen joints||Standard Deviation|Mean
85419|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in TJC|Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population||percent change in tender joints||Standard Deviation|Mean
85420|NCT00951275|Primary|Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.|Week 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
85421|NCT00951275|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement|The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]).|Week 24|ITT Population||percentage of participants||95% Confidence Interval|Number
85422|NCT00951275|Secondary|Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
85423|NCT00951275|Secondary|FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline, Weeks 2, 4, 8,12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
85424|NCT00951275|Secondary|Improvement of Anemia Assessed as Change From Baseline in Hemoglobin|Improvement of anemia was evaluated as change in hemoglobin levels from baseline.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
85425|NCT00951275|Primary|Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin|Hemoglobin levels were measured as grams/deciliter (g/dL).|Week 4|ITT population||g/dL||Standard Deviation|Mean
85426|NCT00951275|Secondary|Mean Hemoglobin Levels During the Study||Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||g/dL||Standard Deviation|Mean
85427|NCT00951171|Secondary|Positive Pregnancy Test||14 days||||||
85428|NCT00951171|Secondary|Live Birth||9 months||||||
85429|NCT00951171|Primary|Clinical Pregnancy|positive beta HCG test|1 month|All study women undergoing IUI were included||positive pregnancy test (beta HCG)|||Number
85430|NCT00951093|Primary|Number of Participants With Increased Acid Exposure|Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
85431|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Supine Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position|Before GBP, 6 months after GBP and 39 months after GBP|||percentage of time||Inter-Quartile Range|Median
85432|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Upright Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position|Before GBP, 6 months after GBP and 39 months after GBP|||percentage of time||Inter-Quartile Range|Median
85433|NCT00951093|Primary|Total Esophageal Acid Exposure at 24h pH Monitoring|Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.|Before GBP, 6 months after GBP and 39 months after GBP|||percentage of time||Inter-Quartile Range|Median
85434|NCT00951093|Primary|Number of Participants With Gastroesophageal Reflux Disease (GERD)|Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
85435|NCT00951093|Primary|Number of Participants With Esophageal Injury|Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
85436|NCT00951093|Primary|Number of Participants Presenting Reflux Symptoms|"Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present.~In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used."|Before GBP, 6 months after GBP and 39 months after GBP|||participants|||Number
85437|NCT00951015|Other Pre-specified|Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points|Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population|||||
85445|NCT00951015|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.||Hours*µg/mL||Geometric Coefficient of Variation|Geometric Mean
85438|NCT00951015|Secondary|Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters|Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).|Week 96|PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.||estimated effect|||Number
85439|NCT00951015|Secondary|Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.|Week 96|PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.||Pearson's correlation coefficient|||Number
85440|NCT00951015|Secondary|Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Week 96|PK/PD Analysis Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK/PD Analysis Population.||Pearson's correlation coefficient|||Number
85441|NCT00951015|Secondary|Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters|Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Week 2|PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures. Only those participants available at the specified time points were analyzed.||Pearson's correlation coefficient|||Number
85442|NCT00951015|Secondary|Time to Maximal Drug Concentration (Tmax) of DTG|tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.||Hours||Full Range|Median
85443|NCT00951015|Secondary|C0 and C0 Avg of DTG|The plasma DTG pre-dose concentration (C0) of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Week 2, Week 12, and Week 24|PK Summary Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
85444|NCT00951015|Secondary|Cmax, Cmin, and Ctau of DTG|The maximal concentration (Cmax), minimal concentration (Cmax), and concentration at the end of dosing interval (Ctau) of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
85464|NCT00950963|Primary|Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL|Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study|18 months|Analysis was per intention to treat.||Participants|||Number
85446|NCT00951015|Secondary|Plasma DTG Concentration|Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters.|Week 2, Week 12, and Week 24|PK Summary Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.||Micrograms per milliliter (µg/mL)||Standard Deviation|Mean
85447|NCT00951015|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data, excluding participants who were not protocol-defined virologic failures.||participants|||Number
85448|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.||participants|||Number
85449|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.||participants|||Number
85450|NCT00951015|Secondary|Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities|Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From Baseline up to Week 96/Early Withdrawal|Safety Population||participants|||Number
85451|NCT00951015|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From Baseline up to Week 96/Early Withdrawal|||participants|||Number
85452|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population||participants|||Number
85465|NCT00950937|Secondary|Peak Oxygen Uptake|Is the maximum capacity of an individual's body to transport and utilize oxygen during incremental exercise.|1 time, before the exercise protocol|||ml/min||Standard Deviation|Median
85453|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population||participants|||Number
85454|NCT00951015|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.|From Baseline up to Week 96|ITT-E Population||participants|||Number
85455|NCT00951015|Secondary|Number of Participants With New HIV-associated Conditions of the Indicated Class|HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.|From Baseline up to Week 96|ITT-E Population||participants|||Number
85456|NCT00951015|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||Cells per cubic millimeter||Inter-Quartile Range|Median
85457|NCT00951015|Secondary|Change From Baseline in HIV-1 RNA at the Indicated Time Points|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.||log10 c/mL||Standard Deviation|Mean
85458|NCT00951015|Secondary|Viral Change Over the Initial 2 Weeks of Treatment|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline.|Baseline and Week 2|ITT-E Population. Only those participants available at the specified time point were analyzed.||log10 c/mL||Standard Deviation|Mean
85459|NCT00951015|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16|Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).|Week 16|Intent-to-Treat Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||participants|||Number
85460|NCT00950963|Secondary|Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study|Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.|18 months|||Participants|||Number
85461|NCT00950963|Secondary|Number of Patients With BP Less Than 130/80 mm Hg|Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.|18 months|Analysis per intention to treat||participants|||Number
85462|NCT00950963|Other Pre-specified|Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.|Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations|18 months|Analysis per intention to treat||Number of ED visits and hospitalizations|||Number
85463|NCT00950963|Secondary|Number of CVD Patients With LDL Less Than 70 mg/dL.||18 months|Analysis was per intention to treat||Participants|||Number
85467|NCT00950937|Secondary|T CD4|T CD4 lymphocytes counts at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||Cell/ul of blood||Inter-Quartile Range|Median
85468|NCT00950937|Secondary|Lipid Peroxidation|Thiobarbituric acid–reactive substances (TBARS) assay was used as an index of lipid peroxidation in erythrocytes, at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||picomol of TBARS/mg protein||Inter-Quartile Range|Median
85469|NCT00950937|Secondary|Glutathione S-transferase (GST)|Antioxidant activity of the Glutathione S-transferase enzyme at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||micromol of GST/min/mg of protein||Inter-Quartile Range|Median
85470|NCT00950937|Primary|Total Glutathione|The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||nmoles glutathione/ ml of sample||Inter-Quartile Range|Median
85471|NCT00950937|Secondary|Catalase Activity|Antioxidant activity of the catalase enzyme at three moments: baseline, aerobic and exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).|||units of catalase /mg protein||Inter-Quartile Range|Median
85472|NCT00950911|Primary|Number of Participants Survived||2 years|Full Analysis Set||Participants|||Number
85473|NCT00950872|Secondary|Incidence of Stapler 'Misfires'|The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||participants|||Number
85474|NCT00950872|Secondary|Length of Hospital Stay|Days spent in the hospital|Day 2 (Approximately 1.5 days post randomization)|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||days||Standard Deviation|Mean
85475|NCT00950872|Secondary|Operating Room (OR) Time|OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||minutes||Standard Deviation|Mean
85476|NCT00950872|Primary|Incidence of Adverse Events.||Day 30|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.||adverse events|||Number
85477|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 hematological toxicities included: Hemoglobin, Platelet Count, Total Neutrophils, and White Blood Cell count.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG||Participants|||Number
85478|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 clinical chemistry toxicities included: Albumin, Alkaline Phosphatase, Amylase, Aspartate Amino Transferase, Carbon dioxide content/Bicarbonate, Creatinine, Creatinine Clearance, Hypercalcemia, Hyperglycaemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycaemia, Hypokalemia, Hyponatremia, LDL Cholesterol, Magnesium, Phosphorus inorganic, and Total Bilirubin, Alanine Amino Transferase, Calcium, Chloride, Cholesterol, Creatine Kinase, Direct Bilirubin, Glucose, High Density Lipid (HDL), Cholesterol direct, Lipase, Potassium, Sodium, Total Cholesterol, Triglycerides, Urea/Blood Urine Nitrogen.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG||Participants|||Number
85479|NCT00950859|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF.The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log 10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log 10 c/mL unless <400 c/mL or an increase of >=1.0 log 10 c/mL from nadir; and at or after Week 16, ≥400 c/mL . PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|PDVF Phenotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time of PDVF failure. Only participants with both Baseline and PDVF time-point DTG phenotypic data were considered for analysis.||Participants|||Number
85523|NCT00950742|Secondary|Number of Patients With Best Overall Response|Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
85480|NCT00950859|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|On-treatment Genotypic Resistance Population: all ITT-E participants who met the criteria for protocol-defined virological failure (PDVF)||Participants|||Number
85481|NCT00950859|Secondary|Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group|Summary of median fold change in sensitivity to DTG by Integrase (IN) mutational group was assessed. The IN mutational group comprises of the following mutations: Q148 +2, Q148 +1, mixture (participants with virus containing more than one Y143, Q148 or N155 mutation at Day 1), Y143, N155, other (participants with virus having no mutations at codons 143, 148, or 155 at Day 1). Fold change (FC) is the fold change in 50% Inhibitory Concentration (IC50) relative to the wild-type control virus.|Baseline (Day 1)|ITT-E Population||Percentage||Full Range|Median
85482|NCT00950859|Secondary|Number of Participants With the Indicated Genotypic Resistance at Baseline|At Baseline, the integrase genotypic results were used to document resistance to raltegravir (RAL) and for the allocation of participants to one of two genotypic groups according to their RAL signature mutations to ensure a broad range of sensitivity to DTG. These results were not used to pre-define subgroup for analysis.|Baseline|ITT-E Population||Participants|||Number
85483|NCT00950859|Secondary|Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion|PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population||Participants|||Number
85484|NCT00950859|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population.||Participants|||Number
85485|NCT00950859|Secondary|Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences|The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population. Participant may have more than one HIV associated condition. Each condition is counted only once per participant, regardless of recurrence.||Participants|||Number
85486|NCT00950859|Secondary|AUC0-24 Assessment of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to 24 hours. AUC0-24 of DTG was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
85487|NCT00950859|Secondary|Tmax of DTG|The tmax is defined as the time of occurrence of the maximum plasma concentration (Cmax). The tmax was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population||Hours||Full Range|Median
85488|NCT00950859|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 10, and Weeks 4 and 24. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose).|Day 10; Weeks 4 and 24|PK Parameter Population||µg/mL||Geometric Coefficient of Variation|Geometric Mean
85489|NCT00950859|Secondary|Cmax, Cmin, and Ctau of DTG|The maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Day 10. Blood samples for pharmacokinetic (PK) assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|Pharmacokinetic (PK) Parameter Population: all participants who provided at least one evaluable PK concentration||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
85490|NCT00950859|Secondary|Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion|Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 . Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 11; Weeks 4, 12, 24, 48, 72, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X in the category titles).||cells per cubic millimeter (mm^3)||Full Range|Median
85491|NCT00950859|Secondary|Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion|ITT-E Population||Percentage of Participants|||Number
85492|NCT00950859|Secondary|Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 4, 12, 24, 48, 72, and 96 per the Food and Drug Administration's Time to Loss of Virological Response (TLOVR) algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline; Weeks 4, 12, 24, 48, 72, and 96|ITT-E Population||Participants|||Number
85493|NCT00950859|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion|Mean change from Baseline in Plasma HIV-1 RNA was assessed on Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of the observed cases. Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, 96, from 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).||Log10 copies/mL||Standard Deviation|Mean
85494|NCT00950859|Primary|Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11|The number of participants who acheived Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11 was assessed. The last observation was carried forward if a participant had missed the Day 11 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 11. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 11.|Baseline (Day 1) and Day 11|Intent-to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline measure of plasma HIV-1 RNA.||Participants|||Number
85495|NCT00950807|Secondary|Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period|Serial FEV1 for OQ dosing is recorded at the pre-AM dose (time 0 h) and at 1, 3, 6, 9, 12,13, 15, 18, 21, 24 and 28 hs after the AM dose on D 14. For BID dosing, the 12 h AM dose corresponds to the pre-PM dose, 13 h AM dose corresponds to the 1 h PM dose, 15 h AM dose corresponds to the 3 h PM dose, 18 h AM corresponds to the 6 h PM dose, 21 h AM dose corresponds to 9 h PM dose, 24 h AM dose corresponds to the 12 h PM dose and 28 h AM dose corresponds to the 16 h PM dose in the table. Analysis performed using a mixed model with covariates of mean BL, period BL, trt, period, time, time by period BL interaction, time by mean BL interaction and time by trt interaction as fixed effects and par. as a random effect. BL is the FEV1 value recorded pre-dose on D 1 of each TP; mean BL is the mean of the BLs for each par. and period BL is the difference between the BL and the mean BL in each TP for each par. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.||Liters||Standard Deviation|Mean
85496|NCT00950807|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour (h) post-dose measurements at Day 14 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24 hours. Analysis performed using a mixed model with covariates mean BL, period BL, treatment and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP; mean BL is the mean of the BLs for each participant and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 14.||Liters||Standard Error|Least Squares Mean
85497|NCT00950807|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Baseline and Day 15 of each treatment period (up to Study Day 71)|Modified Intent-To-Treat (mITT) Population: all participants randomized to treatment who received at least one dose of study medication. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.||Liters||Standard Error|Least Squares Mean
85498|NCT00950755|Secondary|Number of Days Each Participant Took to Reach Hypothyroidism After the First Dosimetric Dose|Hypothyroidism is a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants experiencing hypothyroidism were analyzed.||days|||Number
85499|NCT00950755|Secondary|Number of Participants in the Indicated Categories of Thyroid Function Assessment|Hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood), may result from treatment with radioactive iodine I 131. A thyroid blockade medication was given prior to administration of the study drug and up to 2 weeks after the therapeutic dose to prevent the uptake of I 131 in the thyroid gland. Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the I 131 on thyroid function, such as hypothyroidism.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who were evaluable for thyroid function assessment and who had no elevated TSH level or hypothyroidism at baseline were analyzed.||participants|||Number
85500|NCT00950755|Secondary|Time to HAMA Positivity From First Dosimetric Dose|Time to HAMA positivity is defined as the time from the first dosimetric dose to the first reported HAMA-positive result for the participant.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.||days||Full Range|Median
85501|NCT00950755|Secondary|Number of Participants Who Became Positive or Negative for Human Anti-murine Antibody (HAMA) After Study Treatment|Tositumomab is a murine (mouse) antibody. Participants in this study were evaluated to determine if they developed a human anti-murine antibody (HAMA) immune response after administration of tositumomab and iodine I 131 tositumomab.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population||participants|||Number
85502|NCT00950755|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).||g/dL||Full Range|Median
85503|NCT00950755|Secondary|Nadir Values for Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).||1000 cells/millimeters cubed (mm^3)||Full Range|Median
85504|NCT00950755|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to nadir and time to recovery to baseline. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).||days||Full Range|Median
85524|NCT00950742|Secondary|Number of Patients With Objective Response (OR)|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
86110|NCT00945243|Secondary|Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)|Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.|24 months|8 subjects had data at 24 months.||percentage of subjects|||Number
85505|NCT00950755|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|"ITT Exposed Population. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."||days||Full Range|Median
85506|NCT00950755|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.||participants|||Number
85507|NCT00950755|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population||participants|||Number
85508|NCT00950755|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. All participants who experienced any SAE were analyzed.||participants|||Number
85509|NCT00950755|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population||participants|||Number
85510|NCT00950755|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Only those participants who died during the study and during the follow-up period were analyzed.||months||95% Confidence Interval|Median
85511|NCT00950755|Secondary|Time to Treatment Failure as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced treatment failure were evaluated.||months||95% Confidence Interval|Median
85512|NCT00950755|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. New lesions must be greater than 2 x 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced progression were evaluated.||months||95% Confidence Interval|Median
85525|NCT00950742|Primary|Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)|The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.|28 days|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.||mg|||Number
86111|NCT00945243|Primary|Assessment of Neck Disability Index Scores|Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.|24 months|8 subjects had data at 24 months||percentage of subjects|||Number
85513|NCT00950755|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.||months||95% Confidence Interval|Median
85514|NCT00950755|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.||participants|||Number
85515|NCT00950755|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >4 weeks apart. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease (EOD) must be unchanged or decreased upon follow-up evaluations. If the EOD was unchanged or if further decreases occurred for >=6 months, the participant was reclassified as having a CR.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.||participants|||Number
85516|NCT00950755|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
85517|NCT00950755|Primary|Number of Participants With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.||participants|||Number
85518|NCT00950755|Primary|Number of Participants (Par.) With Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.||participants|||Number
85519|NCT00950742|Secondary|Summary of Concentration of Herceptin in Plasma|Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85520|NCT00950742|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.||hours||Full Range|Median
85521|NCT00950742|Secondary|Summary of Concentration of Afatinib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85522|NCT00950742|Secondary|Progression Free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.|Baseline until disease progression, death or data cut-off.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Days||95% Confidence Interval|Median
85526|NCT00950742|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.|28 days|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.||Participants|||Number
85527|NCT00950729|Primary|Mean Breaking Force Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking force during emergency braking with and without distractor|June 2007 to September 2007|||pounds||Standard Deviation|Mean
85528|NCT00950729|Primary|Mean Breaking Time Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.|June 2007 to September 2007|||seconds||Standard Deviation|Mean
85529|NCT00950690|Primary|Humphrey Perimetry Visual Field|Analysis of visual field deficits for abnormalities.|Visits 1 and 4|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.||decibels||Standard Deviation|Mean
85530|NCT00950690|Primary|Intraocular Pressure|Intraocular pressure was measured at each visit|Screening, 10 days, 4 weeks and 12 weeks after beginning treatment|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.||millimeters of mercury||Standard Deviation|Mean
85531|NCT00950664|Other Pre-specified|Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline|Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.|4, 8, 12 and 16 weeks after injection|||units on a scale||Standard Deviation|Mean
85532|NCT00950664|Other Pre-specified|Reduction of Total TWSTRS at Each Visit From Baseline|TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale.|4, 8, 12 and 16 weeks after injection|||units on a scale||Standard Deviation|Mean
85533|NCT00950664|Secondary|PGI-I (Patient's Global Impression of Improvement)|"The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)~1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated"|4, 8, 12 and 16 weeks after injection|||percentage of scoring 1 or 2|||Number
85534|NCT00950664|Secondary|CGI-I (Clinical Global Impression of Illness)|"The proportion of patients with ‘normal/ not at all ill’ or ‘borderline mildly ill’ on the CGI (Clinical global impression of illness, CGI-I)~1 = normal / not at all ill’; 2 = ‘borderline mildly ill’; 3 = ‘mildly ill’; 4 = ‘moderlately ill’; 5 = ‘markedly ill’; 6 = ‘severely ill’; 7 = ‘the most extremely ill’."|4, 8, 12 and 16 weeks after injection|||percentage of scoring 1 or 2|||Number
85535|NCT00950664|Other Pre-specified|Reduction of Tsui Score at Each Visit From Baseline|Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.|4, 8, 12 and 16 weeks after injection|||units on a scale||Standard Deviation|Mean
85536|NCT00950664|Secondary|Reduction of Total TWSTRS Score at 4 Weeks From Baseline|TWSTRS (Toronto western spasmodic torticollis rating scale) (range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS.|4 weeks after injection from baseline|||units on a scale||Standard Deviation|Mean
85537|NCT00950664|Primary|Reduction of Total Tsui Score at 4 Weeks From Baseline|Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.|4 weeks after injection from baseline|||units on a scale||Standard Deviation|Mean
85538|NCT00950651|Secondary|Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty with stairs with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
85539|NCT00950651|Secondary|Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty walking with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
85540|NCT00950651|Secondary|Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their ability to get things done with their worst knee using a five-point scale ranging from: 1=No problem to 5=A lot of things didn’t get done. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
85541|NCT00950651|Secondary|Patient Diary: Stiffness (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the stiffness in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
85542|NCT00950651|Secondary|Patient Diary: Pain (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the arthritis pain in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||Units on a scale||Standard Deviation|Mean
85543|NCT00950651|Secondary|Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12|The physician was asked to indicate the effectiveness of pain control 24 hours after the most recent dose of tramadol using a 4-point Likert-scale, dichotomized for the analysis: Very Effective, Effective, Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
85544|NCT00950651|Secondary|Physician Overall Rating: Overall Assessment at Week 12|The physician was asked to indicate his overall assessment of the formulation the patient was taking using a 4-point Likert-scale dichotomized for the analysis: Very Effective, Effective, and Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
85545|NCT00950651|Secondary|Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12|Patients who have previously taken tramadol HCl were asked: “Compared to when you were previously taking tramadol, how have any side effects you have felt during this study interfered with your day-to-day activities?”. Possible answers were: “Interfered much less now”, “Interfered somewhat less now”, “Same as before”, “Interfered more now”.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
85546|NCT00950651|Secondary|Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12|"Patients who have previously taken tramadol HCl were asked to compare how they compare the current pain relief to the pain relief felt when previously taking tramadol, using a 4-point Likert-scale: Worse than before, Same as before, Somewhat better now, or “Much better now”."|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
85547|NCT00950651|Secondary|Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12|Patients were asked: “How have any side effects you may have felt from the drug interfered with day-to-day activities?” with 4 possible answers: “Significantly”, “Somewhat”, “Minimally”, “Not at all”.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
85548|NCT00950651|Secondary|Patient Global Rating of Pain Relief at Week 12|"The Patient Global Rating of Pain is a Likert-scale that answers the question: How do you rate overall pain relief with the drug? with 4 possible answers that were dichotomized: very effective, effective, and somewhat effective were summarized to “effective”; “not effective” remained unchanged."|12 Weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
85549|NCT00950651|Secondary|Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12|The walking test is a measure of how many seconds it takes the patient to walk a distance of 15 meters. The change from baseline to week 12 was calculated.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85550|NCT00950651|Secondary|Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12|Patients indicated their Average Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85571|NCT00950612|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85551|NCT00950651|Secondary|Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12|Patients indicated their Worst Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85552|NCT00950651|Secondary|Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12|Patients indicated their Least Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85553|NCT00950651|Secondary|Percentage of Change From Baseline in Current Pain at Week 12|Pain Visual Analogue Scales: Current Pain. Patients indicated their current pain using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change in current pain was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85554|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Total Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Each item is rated on a 100mm VAS scale (0mm=no pain/stiffness/difficulty to 100mm=extreme no pain/stiffness/difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85555|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Physical Function subscale score consists of 17 items rated on a 100mm VAS scale (0mm=no difficulty to 100mm=extreme difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85556|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Stiffness subscale score consists of 2 items each rated on 100mm VAS scale (0mm=no stiffness to 100mm=extreme stiffness). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85557|NCT00950651|Secondary|Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)|Each day before morning dose, patients assessed arthritis pain in worst knee in a diary using a 5-point rating scale ranging from none to severe. A median score was estimated for each patient each week and re-categorized into different degrees of pain (rounding off to the closest integer). Results are of 12th week (day 78-84).|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||participants|||Number
85558|NCT00950651|Primary|Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.||percentage of change||Standard Deviation|Mean
85559|NCT00950612|Secondary|Anti-M72 Specific Antibody Concentrations|Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
85747|NCT00949715|Primary|Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month|Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view|24 months|Subjects who had LVEF measurements from both baseline and 24 month timepoints||percentage of LVEF||95% Confidence Interval|Mean
85560|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
85561|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
85562|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
85563|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
85564|NCT00950612|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.||T cells/million cells||Inter-Quartile Range|Median
85565|NCT00950612|Primary|Number of Subjects With Haematological Levels Below Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85566|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Below Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85567|NCT00950612|Primary|Number of Subjects With Haematological Levels Above Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85568|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Above Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85569|NCT00950612|Primary|Number of Subjects With Normal Haematological Levels|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85570|NCT00950612|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performedon the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85872|NCT00947661|Primary|Change in Intraocular Pressure From Baseline to Week 12|95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)|12 weeks|Intent to treat population without LOCF||mm Hg||Standard Error|Least Squares Mean
85572|NCT00950612|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85573|NCT00950612|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85574|NCT00950612|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
85575|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.||Percentage of participants|||Number
85576|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.||Percentage of participants|||Number
85577|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.||Percentage of participants|||Number
85578|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.||Percentage of participants|||Number
85579|NCT00950599|Secondary|Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control|Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)|Week 4, Week 6||||||
85580|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6||||||
85581|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||||
85582|NCT00950599|Secondary|Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort|Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.|Week 6|Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.||Percentage of Participants|||Number
85583|NCT00950599|Secondary|Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort|Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Deviation|Mean
85584|NCT00950599|Secondary|Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Deviation|Mean
85585|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percent||Standard Deviation|Mean
85586|NCT00950599|Secondary|Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)||umol/L||Standard Deviation|Mean
85587|NCT00950599|Secondary|Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).||umol/L||Standard Deviation|Mean
85588|NCT00950599|Secondary|Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)||mg/dL||Standard Deviation|Mean
85589|NCT00950599|Secondary|Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).||mg/dL||Standard Deviation|Mean
85590|NCT00950599|Secondary|Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)||percentage of glycated hemoglobins||Standard Deviation|Mean
85591|NCT00950599|Secondary|Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).||percentage of glycated hemoglobins||Standard Deviation|Mean
85592|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
85896|NCT00947531|Primary|CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24||week 24||09/2009||||
85593|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
85594|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
85595|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
85596|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
85597|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Deviation|Mean
85598|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEq/mL||Standard Error|Mean
85599|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEq/mL||Standard Error|Mean
85600|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
85601|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
85602|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEg/L||Standard Error|Mean
85603|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mEg/L||Standard Error|Mean
86127|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||participants|||Number
85604|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
85605|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||pg/mL||Standard Error|Mean
85606|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85607|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85608|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85609|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85610|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85611|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85612|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85613|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85614|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85615|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85845|NCT00948090|Secondary|Number of Death Events in 2 Years.|The time of overall survival was defined as the time from transplantation to death of all causes.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Deaths|||Number
85616|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85617|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85618|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85619|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85620|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85621|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85622|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85623|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85624|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85625|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85626|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85627|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85748|NCT00949702|Secondary|Percentage of Patients With Adverse Event|The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants|||Number
85628|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85629|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85630|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85631|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85632|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85633|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85634|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85635|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85636|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85637|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85638|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85639|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85640|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85641|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85642|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng*min/mL||Standard Error|Mean
85643|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng*min/mL||Standard Error|Mean
85644|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU*min/mL||Standard Error|Mean
85645|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU*min/mL||Standard Error|Mean
85646|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg*min/dL||Standard Error|Mean
85647|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg*min/dL||Standard Error|Mean
85648|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85649|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||ng/mL||Standard Error|Mean
85650|NCT00950599|Secondary|Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
86128|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR||Standard Deviation|Mean
85651|NCT00950599|Secondary|Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||uU/mL||Standard Error|Mean
85652|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||umol/L||Standard Error|Mean
85653|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||umol/L||Standard Error|Mean
85654|NCT00950599|Secondary|Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85655|NCT00950599|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
85656|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percentage of glycosylated hemoglobins||Standard Error|Mean
85657|NCT00950599|Primary|Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percentage of glycosylated hemoglobins||Standard Error|Mean
85658|NCT00950599|Primary|Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort|Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.|Baseline, Week 12|Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||percentage of glycosylated hemoglobins||Standard Deviation|Mean
85659|NCT00950352|Secondary|Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.|Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.|Throughout the course of the study||||||
85660|NCT00950352|Secondary|Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.|Phosphorus-31 ((31)P) magnetic resonance spectroscopy (MRS) was used to evaluate changes in mitochondrial high energy phosphates, including phosphocreatine (PCr) and β-nucleoside triphosphate (β-NTP, primarily ATP in brain) levels.|Neuroimaging will occur at week 0 and week 8/9||||||
85661|NCT00950352|Secondary|Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.|Cognitive measurement tests will be employed.|Neuropsychological testing will occur at week 0 and week 8/9||||||
85662|NCT00950352|Primary|Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo|Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.|8 weeks, assessed twice weekly starting week1|||total amount consumed in grams||Standard Deviation|Mean
85663|NCT00950300|Secondary|Percentage of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)|Participants in the Herceptin SC arm provided samples for evaluation of anti-rHuPH20 antibodies. The cumulative percentage of participants with ADAs against rHuPH20 (an excipient unique to the SC formulation) at any time during or after treatment was reported.|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48 from last dose of Cycle 18|Safety Population; only participants with evaluable Baseline and post-Baseline data for ADAs against rHuPH20 were included.||percentage of participants|||Number
85664|NCT00950300|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab|Participants provided samples for evaluation of anti-trastuzumab antibodies. The cumulative percentage of participants with ADAs against trastuzumab at any time during or after treatment was reported.|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48 from last dose of Cycle 18|Safety Population: All participants who received at least one dose of study medication. Only participants with evaluable Baseline and post-Baseline data for ADAs against trastuzumab were included.||percentage of participants|||Number
85770|NCT00949650|Secondary|Percentage of Participants With Disease Control (DC)|DC is defined as a patient with OR or stable disease (SD). Assessed by central independent review according to the RECIST 1.1. Only data collected until the primary endpoint analysis cut-off date were considered.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks|RS||Percentage of Participants with DC||95% Confidence Interval|Number
85665|NCT00950300|Secondary|Overall Survival (OS) as of Clinical Cutoff in January 2014|OS was estimated by Kaplan-Meier analysis and defined as the time from randomization to death from any cause. Participants who were alive at the time of analysis were censored at the day of last study drug administration, last recorded visit, or last survival follow-up information.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||months||Full Range|Median
85666|NCT00950300|Secondary|Percentage of Participants Who Died as of Clinical Cutoff in January 2014|The percentage of participants who died at any time during the study was reported.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||percentage of participants|||Number
85667|NCT00950300|Secondary|Event-Free Survival (EFS) as of Clinical Cutoff in January 2014|Protocol-defined events included local, regional, or distant recurrence, contralateral breast cancer, or death from any cause. After the last dose of treatment, imaging was performed at specified visits and participants were followed for survival status. EFS was estimated by Kaplan-Meier analysis and defined as the time from randomization to the first protocol-defined event. For participants without an event at the time of analysis, EFS was censored and the date of censoring was the date of last tumor assessment or last recorded visit for the participant.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||months||Full Range|Median
85668|NCT00950300|Secondary|Percentage of Participants Who Experienced a Protocol-Defined Event as of Clinical Cutoff in January 2014|Protocol-defined events included local, regional, or distant recurrence, contralateral breast cancer, or death from any cause. After the last dose of treatment, imaging was performed at specified visits and participants were followed for survival status. The percentage of participants who experienced a protocol-defined event at any time during the study was reported.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (approximately 4 years as of January 2014 data cutoff)|ITT Population.||percentage of participants|||Number
85669|NCT00950300|Secondary|Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm with no prior assessment of PD. PR was defined as ≥30% decrease from Baseline in sum diameter of target lesions with no prior assessment of PD. Time to response was defined as the time from first dose of study medication to the first assessment of CR or PR, which was the date the response was first documented by objective evidence, among participants with an overall response of CR or PR.|Tumor assessments at Baseline; on Day 1 Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline and a response of CR or PR were included.||weeks||Full Range|Median
85670|NCT00950300|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm) with no prior assessment of progressive disease (PD). PR was defined as greater than or equal to (≥) 30% decrease from Baseline in sum diameter of target lesions with no prior assessment of PD. The percentage of participants with overall response of CR or PR at the end of neoadjuvant treatment was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|Tumor assessments at Baseline; on Day 1 of Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline were included.||percentage of participants||95% Confidence Interval|Number
85671|NCT00950300|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination. The percentage of participants with tpCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|EPP Population.||percentage of participants||95% Confidence Interval|Number
85672|NCT00950300|Secondary|AUC21d of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 12 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in d*μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.||d*μg/mL||Standard Deviation|Mean
85673|NCT00950300|Secondary|Tmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Tmax during Cycle 12 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.||days||Standard Deviation|Mean
85674|NCT00950300|Secondary|Cmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Cmax during Cycle 12 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.||μg/mL||Standard Deviation|Mean
86129|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
85675|NCT00950300|Secondary|Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 7 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in days multiplied by micrograms per milliliters (d*μg/mL).|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.||d*μg/mL||Standard Deviation|Mean
85676|NCT00950300|Secondary|Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Tmax during Cycle 7 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.||days||Standard Deviation|Mean
85677|NCT00950300|Secondary|Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Cmax during Cycle 7 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.||μg/mL||Standard Deviation|Mean
85678|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population.||participants|||Number
85679|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population.||participants|||Number
85680|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab After Surgery|Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|PKPP Population; only participants with a Cycle 13 pre-dose PK measurement were included in the analysis.||μg/mL||Standard Deviation|Mean
85681|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab Prior to Surgery|Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|PKPP Population: All participants with at least one measurable trastuzumab serum concentration.||μg/mL||Standard Deviation|Mean
85682|NCT00950300|Secondary|Observed Ctrough of Trastuzumab After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the secondary endpoint.||μg/mL||Standard Deviation|Mean
85683|NCT00950300|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|Efficacy (E) PP Population: All participants with at least one on-treatment efficacy assessment who received a full eight cycles of study treatment according to randomization and who met additional protocol-specified criteria.||percentage of participants||95% Confidence Interval|Number
85684|NCT00950300|Primary|Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary endpoint.||μg/mL||Standard Deviation|Mean
85685|NCT00950235|Secondary|Large for Gestational Age (LGA)|Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.|At birth|Babies born to participants||participants|||Number
85686|NCT00950235|Secondary|Pregnancy Weight Change||baseline to 34 weeks gestation|Participants returning for follow up visit or validated clinical data||kg||Standard Deviation|Mean
85687|NCT00950235|Primary|Maternal Weight Change|We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.|baseline to 2 weeks post partum|Data was from follow up visit or validated clinical data||kg||Standard Deviation|Mean
85688|NCT00950183|Secondary|Postoperative Complications||postop day 1 up to postop day 14|Data not analyzed due to study termination|||||
85689|NCT00950183|Secondary|Surgical Complications||Day of Surgery|Data not analyzed due to study termination|||||
85690|NCT00950183|Secondary|Patient Satisfaction||first postoperative visit (between postop day 10 and 14)|Data not analyzed due to study termination|||||
85691|NCT00950183|Secondary|Narcotic Pain Medication Usage||postop day 1 up to postop day 14|Data not analyzed due to study termination.|||||
85692|NCT00950183|Primary|Visual Analog Scale (VAS) Pain Scores||postop day 1 up to postop day 14|Data not analyzed due to study termination|||||
85916|NCT00947349|Primary|Assessment of Tolerability in Triple Combination Therapy|An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.||participants|||Number
85693|NCT00949975|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Participants|||Number
85694|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George’s Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
85695|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George’s Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Deviation|Mean
85696|NCT00949975|Secondary|Six-minute Walk Test - End-value Distance Walked (m)|distance walked on vist 6 - last on treatment clinic visit|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||m||Standard Error|Least Squares Mean
85697|NCT00949975|Secondary|Six-minute Walk Test - Distance Walked at Baseline (m)||Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||m||Standard Deviation|Mean
85698|NCT00949975|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Inhalations||Standard Error|Least Squares Mean
85699|NCT00949975|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12|Measured at clinic visits:1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Error|Least Squares Mean
85700|NCT00949975|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
85701|NCT00949975|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Error|Least Squares Mean
85702|NCT00949975|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
85703|NCT00949975|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Error|Least Squares Mean
85716|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
85704|NCT00949975|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Units on a scale||Standard Deviation|Mean
85705|NCT00949975|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
85706|NCT00949975|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
85707|NCT00949975|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
85708|NCT00949975|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Deviation|Mean
85709|NCT00949975|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
85710|NCT00949975|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
85711|NCT00949975|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
85712|NCT00949975|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
85713|NCT00949975|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
85714|NCT00949975|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
85715|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
85979|NCT00946920|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix|This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.|From Day 28 to Day 364|FAS.||percentage of participants||95% Confidence Interval|Number
85717|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
85718|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
85719|NCT00949975|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
85720|NCT00949975|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Deviation|Mean
85721|NCT00949910|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.||months||95% Confidence Interval|Median
85722|NCT00949910|Secondary|Percentage of Participants Who Died|The percentage of participants (in nearest integer) who died from any cause was reported.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
85723|NCT00949910|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.||months||95% Confidence Interval|Median
85724|NCT00949910|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.||percentage of participants|||Number
85725|NCT00949910|Secondary|Percentage of Participants by Best Overall Response According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but <20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is <1) with each type of best overall response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
85726|NCT00949910|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
85727|NCT00949910|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.||percentage of participants|||Number
85728|NCT00949884|Other Pre-specified|Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure|The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Baseline, Week 2|The efficacy population was defined as participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.||mmHg||Standard Error|Least Squares Mean
85729|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
85730|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
85731|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
85732|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.||mmHg||Standard Error|Least Squares Mean
85733|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 8|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 8 ABPM data.||mmHg||Standard Error|Least Squares Mean
85734|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 4|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data.||mmHg||Standard Error|Least Squares Mean
85735|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 8|"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg"|Week 8|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.||percentage of participants analyzed|||Number
85736|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 4|"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg"|Week 4|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.||percentage of participants analyzed|||Number
85746|NCT00949715|Secondary|Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.|Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.|24 months|Patients that had both 2 week and 24 month follow-up echo data with a 4 chamber LVEF measurement||percentage of LVEF||95% Confidence Interval|Mean
85737|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
85738|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
85739|NCT00949884|Post-Hoc|Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8|Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am.|Week 8|Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data.||percentage of population|||Number
85740|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
85741|NCT00949884|Secondary|Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
85742|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward||mmHg||Standard Error|Least Squares Mean
85743|NCT00949884|Primary|Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.||mmHg||Standard Error|Least Squares Mean
85744|NCT00949715|Secondary|Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.|Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.|Whole time from baseline to 24 months averaged by day|All subjects who meet inclusion/exclusion criteria for the study.||minutes per day||Standard Deviation|Mean
85745|NCT00949715|Secondary|Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.|Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.|24 months|All subjects who had 4 chamber LV end systolic volume at both the baseline and the 24 month time points||mL||95% Confidence Interval|Mean
85749|NCT00949702|Secondary|Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)|Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.|Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1|Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.||ms||95% Confidence Interval|Mean
85750|NCT00949702|Secondary|Vemurafenib Plasma Levels at Various Treatment Cycles|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.|Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.||μg/mL||Standard Deviation|Mean
85751|NCT00949702|Secondary|Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.||μg⋅h/mL||Standard Deviation|Mean
85752|NCT00949702|Secondary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.||μg/mL||Standard Deviation|Mean
85753|NCT00949702|Secondary|Improvement in Physical Symptoms (Improvement in Physician’s Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline|Three parameters were measured. (1) Improvement in the Physician’s Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants||95% Confidence Interval|Number
85754|NCT00949702|Secondary|Overall Survival|Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||95% Confidence Interval|Median
85755|NCT00949702|Secondary|Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||95% Confidence Interval|Median
85756|NCT00949702|Secondary|Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||Inter-Quartile Range|Median
85757|NCT00949702|Secondary|Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Months||95% Confidence Interval|Median
85771|NCT00949650|Secondary|Percentage of Patients With Objective Response (OR)|OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.1. Only data collected until the primary endpoint analysis cut-off date (09 February 2012) were considered.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks|RS||Percentage of patients with OR||95% Confidence Interval|Number
85980|NCT00946478|Primary|Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD|Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo|3 weeks|||delta-delta ct units on PCR||Standard Error|Mean
85758|NCT00949702|Secondary|Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants||95% Confidence Interval|Number
85759|NCT00949702|Primary|Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.||Percentage of participants||95% Confidence Interval|Number
85760|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 43|Trough plasma concentrations of afatinib at day 43 (course 3, visit 1) after multiple daily dosing of 40mg afatinib and after dose escalation to 50 mg or dose reduction to 30mg or 20mg.|Day 43|Patients from the treated set with evaluable data and who had at least 1 valid afatinib plasma concentration available on this time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85761|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 29|Trough plasma concentrations of afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40mg afatinib and after dose escalation to 50 mg or dose reduction to 30mg or 20mg.|Day 29|Patients from the treated set with evaluable data and who had at least 1 valid afatinib plasma concentration available on this time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85762|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 22|Trough plasma concentrations of afatinib at day 22 (course 2, visit 1) after multiple daily dosing of 40mg afatinib and after dose escalation to 50 mg or dose reduction to 30mg or 20mg.|Day 22|Patients from the treated set with evaluable data and who had at least 1 valid afatinib plasma concentration available on this time point.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85763|NCT00949650|Secondary|HRQOL: Time to Deterioration in Pain|HRQOL was measured by EORTC QLQ-C30 and its lung cancerspecific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks)|RS||months||95% Confidence Interval|Median
85764|NCT00949650|Secondary|HRQOL: Time to Deterioration in Dyspnoea|HRQOL was measured by EORTC QLQ-C30 and its lung cancerspecific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks)|RS||months||95% Confidence Interval|Median
85765|NCT00949650|Secondary|Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing|HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancerspecific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks)|RS.||months||95% Confidence Interval|Median
85766|NCT00949650|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS measured on 6 point scale to assess participants performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours; 4=Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5=Dead.|Throughout the trial until progression (every 3 weeks), up to 28 month|RS. Only patients with baseline and at least one post-baseline assessment were included.||Participants|||Number
85767|NCT00949650|Secondary|Change From Baseline in Body Weight|Because the PFS was longer for patients in the afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the afatinib arm.|Baseline and throughout the trial until progression (every 3 weeks), up to 28 month|RS. Only patients with baseline and at least one post-baseline assessment were included.||kg||Standard Deviation|Mean
85768|NCT00949650|Secondary|Tumour Shrinkage|Tumour shrinkage is calculated as the minimum sum of diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values are presented after adjusting for baseline SoD, EGFR mutation group and race.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks|RS. There were only 204 patients in the Afatinib 40 mg arm and 100 patients in the Pemetrexed / Cisplatin Chemotherapy with tumour measurements.||mm||Standard Error|Mean
85769|NCT00949650|Secondary|Overall Survival (OS) Time|OS is defined as time from randomisation to death.|From randomisation to primary endpoint analysis cut-off date.|RS.||months||95% Confidence Interval|Median
85981|NCT00946348|Secondary|To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.||Over 8 hours||||||
85772|NCT00949650|Primary|Progression-free Survival (PFS) Time|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates. Only data collected until the primary endpoint analysis cut-off date (09 February 2012) were considered.|Tumour assessments were performed at screening, Week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks or until death|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment, whether treated or not.||months||95% Confidence Interval|Median
85773|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected|Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category.|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."||participants|||Number
85774|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms|"Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. Other in the category included abdominal pain, breathlessness, thoracic pain and tired."|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."||participants|||Number
85775|NCT00949533|Secondary|Percentage of Participants With A Reduction in Viral Load|Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load.|Baseline, Day 5|ITT population.||percentage of participants|||Number
85776|NCT00949533|Primary|Percentage of Participants Excreting Resistant Virus|Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."||percentage of participants|||Number
85777|NCT00949117|Secondary|Change in Weight for Age Z-score From Baseline Through 24 Weeks|Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.|Baseline and 24 weeks|||z score||Standard Deviation|Mean
85778|NCT00949117|Secondary|Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24||24 weeks|Outcome not assessed as the one subject that completed the protocol was too young to complete the PedsFAACT quality of life assessment.|||||
85779|NCT00949117|Secondary|Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition||24 weeks|Outcome not assessed as the one subject that completed the protocol did not have the prealbumin lab drawn at the 24 week visit and body composition tests assessed.|||||
85780|NCT00949117|Secondary|Body Mass Index as Assessed at Baseline and 24 Weeks|Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.|24 weeks|||kg/m^2||Standard Deviation|Mean
85781|NCT00949117|Primary|Difference Between Measures of Weight at Baseline and at Week 24|Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.|24 weeks|||kilograms||Standard Deviation|Mean
85782|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants|The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria.|Randomization to 24 months of age|||Episodes per person year at risk|||Number
85783|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants|The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6–24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.|6 to 24 months of age|||Episode per person year at risk|||Number
85784|NCT00948896|Secondary|Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk||24 months to 36 months of age|||Incidence per person year at risk|||Number
85785|NCT00948896|Secondary|Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs|NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004|Time from randomization until 24 months of age|||incidence per person-year at risk|||Number
85786|NCT00948857|Primary|Live Birth|Live Birth outcome compared between DHEA active treatment and Placebo|9 months|This study was closed for futility because of difficulty finding patients willing to undergo randomization.||participants|||Number
85787|NCT00948857|Secondary|Clinical Pregnancy||12 months||||||
85788|NCT00948857|Secondary|Androgen Side Effects||12 months||||||
85789|NCT00948857|Secondary|Endocrine Effects||12 months||||||
85790|NCT00948857|Primary|Live Birth||24 months||||||
85791|NCT00948818|Secondary|12-Week Percent of Abdominal Pain-free (APF) Days|"Abdominal pain free (APF) days are those days where the patient reported a score of ‘0’ for abdominal pain at its worst~Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Percent||Standard Deviation|Mean
85846|NCT00948090|Primary|Number of Progression Events in 2 Years.|The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the Intent-to-treat (ITT) data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Event|||Number
85792|NCT00948818|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.~The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
85793|NCT00948818|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
85794|NCT00948818|Secondary|12-Week Change in Bloating|Bloating was assessed on an 11-point scale where a value of 0 is “none” and a value of 10 is “very severe”.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
85795|NCT00948818|Secondary|12-Week Change in Abdominal Discomfort|Abdominal Discomfort is measured on an 11-point scale where a value of 0 is “none” and a value of 10 is “very severe.”|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
85796|NCT00948818|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
85797|NCT00948818|Secondary|12-Week Severity of Straining|Straining is measured on a 5-point scale where a value of 1 is “not at all” and a value of 5 is “an extreme amount.|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
85798|NCT00948818|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
85799|NCT00948818|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency Rate|The number of Spontaneous Bowl Movements experienced per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||SBMs per week||Standard Error|Least Squares Mean
85800|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.|"A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.~The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
85801|NCT00948818|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.~The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
85847|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase II, Baseline to 60 days following first treatment.|Of the 79 participants enrolled, 78 were evaluable and 1 participant withdrew from study.||participants|||Number
85802|NCT00948818|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Participant|||Number
85803|NCT00948818|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||CSBMs per Week||Standard Error|Least Squares Mean
85804|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||Participants|||Number
85805|NCT00948792|Primary|30 Minute-6 Hour Difference in Platelet Counts||30 minutes - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.||Platelets (*10^3/mm^3)|Participants|Full Range|Median
85806|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.|Baseline - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.||Platelets (*10^3/mm^3)|Participants|Full Range|Median
85807|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.|Baseline-30 minutes after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.||Platelets (*10^3/mm^3)|Participants|Full Range|Median
85808|NCT00948766|Secondary|Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician’s rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient’s treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient’s available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.||Percentage of patients|||Number
85809|NCT00948766|Secondary|Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
85816|NCT00948675|Secondary|Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate)|Overall Response rate (ORR) is the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.||percentage of participants||95% Confidence Interval|Number
86011|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
85810|NCT00948766|Secondary|Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
85811|NCT00948766|Secondary|Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24|The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
85812|NCT00948766|Secondary|Core Study: Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician’s rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient’s treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient’s available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Percentage of patients|||Number
85813|NCT00948766|Primary|Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
85814|NCT00948766|Primary|Core Study: Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
85815|NCT00948675|Secondary|Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD)|Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.||percentage of participants||95% Confidence Interval|Number
85817|NCT00948675|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.|Randomization to date of death from any cause up to 39.49 months|All randomized participants. The number of participants censored was 52 for pemetrexed + carboplatin group and 56 for paclitaxel + carboplatin + bevacizumab group.||months||90% Confidence Interval|Median
85818|NCT00948675|Secondary|Progression Free Survival (PFS)|PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease up to 39.49 months|All randomized participants. The number of participants censored was 35 for pemetrexed + carboplatin group and 49 for paclitaxel + carboplatin + bevacizumab group.||months||90% Confidence Interval|Median
85819|NCT00948675|Primary|Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease or treatment discontinuation up to 39.49 months|All randomized participants. The number of participants censored was 30 for pemetrexed + carboplatin group and 35 for paclitaxel + carboplatin + bevacizumab group.||months||90% Confidence Interval|Median
85820|NCT00948506|Secondary|Subject-reported Adverse Events or Abnormal Findings|Number of participants who reported an adverse event (as assessed by subject interview and if indicated, physical exam) or had abnormal finding on urine and blood laboratory examination|up to 16 weeks|The analysis was performed using intention-to-treat, whereby all enrolled participants who received treatment were analyzed.||participants|||Number
85821|NCT00948506|Primary|Physician's Global Assessment (PGA) of Hair Density|Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).|up to 8 weeks or end of active treatment|The analysis was performed using intention-to-treat and all enrolled participants who received treatment were included in the analysis. For participants who withdrew during treatment, the data from their last visit were carried forward.||participants|||Number
85822|NCT00947505|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline|Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region|16 and 26 weeks|||change in terminal hair count||Standard Deviation|Mean
85823|NCT00948441|Secondary|Safety, Side Effects|collection of adverse events and safety information. Each participant was contacted either at a clinical visit or by phone every two weeks while enrolled in the study.|7 months per study patient|collected adverse events during each time period||participants|||Number
85824|NCT00948441|Primary|Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.|For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.|7 months per study patient|This was a crossover study. Each participant served as their own control. Infections in each time period of the study were compared. Infections with using ethanol locks and infections while using heparin locks.||number of CRBSI per 1000 catheter days|||Number
85825|NCT00948389|Other Pre-specified|Number of Participants With Disease Progression at 12 Months|As measured by brain magnetic resonance imaging.|12 months|Treated participants||participants|||Number
85826|NCT00948389|Primary|Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria|Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants||participants|||Number
85827|NCT00948389|Primary|Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria|Neutrophils (neutropenia): Grade (gr)1 <LLN–1500/mm3; Gr2 <1500–1000/mm3; Gr3 <1000–500/mm3; Gr4 <500/mm3. Leukocytes (leukopenia): Gr1 <LLN–3000/mm3; Gr2 <3000–2000/mm3; Gr3 <2000–1000/mm3; Gr4 <1000/mm3. Lymphocytes (lymphocytopenia): Gr1 <LLN–800/mm3; Gr2 <800–500/mm3; Gr3 <500–200/mm3; Gr4 <200/mm3. Platelets (thrombocytopenia): Gr1 <LLN–75,000/mm3; Gr2 <75,000–50,000/mm3; Gr3 <50,000–25,000/mm3; Gr4 <25,000/mm3. Hemoglobin (anemia): Gr1 <LLN–10.0 g/dL; Gr2 <10.0–8.0 g/dL; Gr3 <8.0–6.5 g/dL; Gr4 <6.5 g/dL. LLN/ULN=lower/upper limit of normal (normal ranges may vary by local laboratories).|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants||participants|||Number
85828|NCT00948389|Primary|Deaths Within 30 Days of Protocol Treatment Discontinuation||From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0).|Treated participants||participants|||Number
85844|NCT00948090|Secondary|Number of Transplant-related Death Events Until Day 100.|Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100.|Day 100|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Transplant-related death|||Number
85829|NCT00948389|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts <0.5x10^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count <1x10^9/L and fever of >=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents.|The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1.|Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation.||participants|||Number
85830|NCT00948389|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs|SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|All treated participants||participants|||Number
85831|NCT00948246|Secondary|Change in Weight|Change in weight (in kilograms) at baseline to 12 months|12 months|||pounds||95% Confidence Interval|Mean
85832|NCT00948246|Secondary|Change in BMI|Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months|12 months|||kg/m2||95% Confidence Interval|Mean
85833|NCT00948246|Secondary|% Excess Weight Loss|Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.|12 months|||percentage of excess weight loss||95% Confidence Interval|Mean
85834|NCT00948246|Primary|Feasibility and Ease of Implantation|"Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is very easy and 5 is impossible."|< 1day|Intent-to-treat||percentage of subjects|||Number
85835|NCT00948155|Secondary|Subjective Measures to Assess Smoking Urges|Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach’s α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period.|Days 21 of each of the two 21-day study periods, range 1(low)-7(high)|Subjects who completed both 21 day placebo and drug periods.||units on a scale||Standard Deviation|Mean
85836|NCT00948155|Secondary|Carbon Monoxide Levels|Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||parts per million||Standard Error|Mean
85837|NCT00948155|Secondary|Cotinine Levels From Urine Samples|Cotinine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||micromolar||Standard Deviation|Mean
85838|NCT00948155|Secondary|Nicotine Levels From Urine Samples|Nicotine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||micromolar||Standard Deviation|Mean
85839|NCT00948155|Secondary|Total Nicotine Metabolites From Urine Samples|Total urinary metabolites from urine samples collected at Day 1 and Day 21|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.||micromolar||Standard Deviation|Mean
85840|NCT00948155|Primary|Daily Cigarette Consumption|Average of the number of cigarettes smoked per day|Two 21 day study periods|||number of cigarettes smoked per day||Standard Error|Mean
85841|NCT00948155|Primary|The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.|Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.|Days 1, 7, 21 of each of two 21 day study periods|All participants who completed the task were included in the analysis||number of puffs chosen of a maximum 24||Standard Error|Mean
85842|NCT00948155|Primary|Smoking Topography: Total Puff Volume|Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.|Days 1-21 of each of 2 study periods|All those participants who completed both study periods were included in the analysis.||milliliters||Standard Error|Mean
85843|NCT00948090|Secondary|Overall Response Rate|The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points.|Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination)|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.||Participants|||Number
85848|NCT00948064|Primary|Response Rate|Number of participants with Complete Response (CR) in AML requiring disappearance of all signs and symptoms related to disease, normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a marrow with 5% or less marrow blasts; a hematologic improvement (HI) defined as a CR except for a platelet count increase by 50% to above 30 x 10^9/L. For MDS, the International Working Group criteria used to assess response.|12-18 Months|Out of 79 participants enrolled in Phase II, 2 participants were not evaluable - 1 participant was removed from study per treating physician discretion and the other was removed per participant's request.||participants|||Number
85849|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase I, Baseline to 60 days following first treatment.|Of the 31 enrolled participants, 30 were evaluable and 1 participant never received treatment.||participants|||Number
85850|NCT00947882|Secondary|Mean Change in Maximum Urinary Flow (Qmax)|Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
85851|NCT00947882|Secondary|Mean Percentage Change in Total Prostate Volume (TPV)|TPV was measured directly by standardised trans-rectal ultrasound (TRUS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
85852|NCT00947882|Secondary|Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS|A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.|At Month 3, Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage of participants|||Number
85853|NCT00947882|Secondary|Mean Change in IPSS|This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.|From Baseline to Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
85854|NCT00947882|Primary|Mean Change in International Prostate Symptom Score (IPSS)|"This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days.~The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score."|From Baseline to Month 3 after Dosing|"FAS. The as planned patient allocation for treatment groups was used in the efficacy analyses (please refer to the Baseline Characteristics section)."||percentage change from baseline||Standard Deviation|Mean
85855|NCT00947856|Secondary|Incidence of Antitherapeutic Antibodies|Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment|Up to 39 months|Any patient who received extension treatment or retreatment and had baseline and postbaseline sample results; 1 HL patient on the retreatment arm did not have postbaseline sample results and 3 ALCL patients on the retreatment arm were retreated more than once and had samples.||participants or experiences|Retreatment or Extension Txt Experiences||Number
85856|NCT00947856|Secondary|Overall Survival|Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause|Up to approximately 41 months|Patients who received treatment on the extension arm, and patients who received retreatment and had postbaseline response results; 1 HL patient on the retreatment arm did not have postbaseline response results and 3 ALCL patients on the retreatment arm were retreated more than once.||months|Retreatment or Extension Trt Experiences|95% Confidence Interval|Median
85857|NCT00947856|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause|Up to approximately 29 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.||months|Retreatment Experiences|95% Confidence Interval|Median
85858|NCT00947856|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death|Up to 38 months|Participants with objective response among those who received retreatment||months|Retreatment Experiences|95% Confidence Interval|Median
85859|NCT00947856|Primary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|Up to 39 months|All participants who received treatment||participants|||Number
85871|NCT00947752|Primary|Subject-reported Pain Associated Immediately After Each Injection|A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.||Scores on a scale||Standard Deviation|Mean
85860|NCT00947856|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 39 months|All participants who received treatment||participants|||Number
85861|NCT00947856|Primary|Objective Response Rate by Investigator|Percentage of participants in the retreatment arm who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 38 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.||percentage of retreatment experiences|Retreatment Experiences|95% Confidence Interval|Number
85862|NCT00947765|Primary|Pain(at 6 Months): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|6 months|||Units on a scale||Standard Deviation|Mean
85863|NCT00947765|Primary|Pain(at 6 Months): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|6 months|||Units on a scale||Standard Deviation|Mean
85864|NCT00947765|Primary|Pain(at 12 Weeks): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|12 weeks|||Units on a scale||Standard Deviation|Mean
85865|NCT00947765|Primary|Pain(at 12 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|12 weeks|||Units on a scale||Standard Deviation|Mean
85866|NCT00947765|Primary|Pain(at 4 Weeks): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|4 weeks|||Units on a scale||Standard Deviation|Mean
85867|NCT00947765|Primary|Pain(at 4 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|4 weeks|||Units on a scale||Standard Deviation|Mean
85868|NCT00947765|Primary|Pain(at 1 Week): Nirschl Staging (0 to 7)|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.||Units on a scale||Standard Deviation|Mean
85869|NCT00947765|Primary|Pain (at 1 Week): Visual Analogue Scale(0 to 10)|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever."|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.||Units on a scale||Standard Deviation|Mean
85870|NCT00947752|Secondary|Degree of Pain Within 5 Mins After Injection|A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.||Scores on a scale||Standard Deviation|Mean
86012|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
85873|NCT00947544|Secondary|Quality of Life Assessed by the SF-15 Questionnaire|"change from baseline to Month 12.~The SF 15 questionnaire consists of 15 questions that assess the following:~Physical functioning (5 questions)~Emotional functioning (4 questions)~Social functioning (3 questions)~School functioning (3 questions) Items were scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or a 3-point scale (0 [not at all], 2 [sometimes], or 4 [a lot] for the young child self-report). Items were reverse-scored and linearly transformed to a 0–100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score was 0-100 scale (averaged from each functional areas). In the 0-100 scale, 0 is the worst score and 100 is best score.~Improved quality of life was shown by increased total score from baseline to Month 12."|1 year|Patients who completed SF-15 at baseline and Month 12 both time in the safety extension period.||score on a scale|total score from SF-15 report|Standard Deviation|Mean
85874|NCT00947544|Secondary|Plasma PAGN AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||μg*h/mL AUC 0-24||Standard Deviation|Mean
85875|NCT00947544|Secondary|Plasma PBA (Phenylbutyrate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||µg*h/ml AUC 0-24||Standard Deviation|Mean
85876|NCT00947544|Secondary|Plasma PAA (Phenylacetate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||μg•h/mL AUC 0-24||Standard Deviation|Mean
85877|NCT00947544|Secondary|Urinary PAGN 24-hour Excretion Values on NaPBA vs. HPN-100 (Switch Over)|Urinary PAGN (phenylacetylglutamine) 24-hour excretion. Urine was collect during 0-12 hrs and 12-24 hrs.|Day 7 (NaPBA) and Day 14 (HPN-100)|||μg||Standard Deviation|Mean
85878|NCT00947544|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA vs. HPN-100|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||percentage of sample|number of blood sample||Number
85879|NCT00947544|Secondary|Average Ammonia Values on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug (Switch Over)|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||µmol/L||Standard Deviation|Mean
85880|NCT00947544|Secondary|NH3 Cmax on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)|||μmol/L||Standard Deviation|Mean
85881|NCT00947544|Secondary|Blood Ammonia Control|To evaluate control of blood ammonia by HPN-100 compared with NaPBA in pediatric patients with UCDs.|Day 7 (NaPBA) and Day 14 (HPN-100)|||μmol∙h/L||Standard Deviation|Mean
85882|NCT00947544|Secondary|Number and Causes of Hyperammonemic Events (Safety Extension)|"Number of Subjects with at Least One Hyperammonemic Crisis.~Hyperammonemic crisis is defined as follows:~• Clinical symptoms associated with ammonia of ≥ 100 µmol/L"|1 year|||participants|||Number
85883|NCT00947544|Primary|Rate of Adverse Events During the Switchover Part of the Study Rate of Adverse Events (Number of Participants Showing Adverse Events)|To evaluate the safety and PK characteristics of HPN-100 compared with sodium phenylbutyrate (NaPBA) in pediatric patients with urea cycle disorders (UCDs)|1 week on each treatment for a total of 2 week.|||participants|||Number
85884|NCT00947531|Secondary|Combined Response, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 24||||||
85885|NCT00947531|Secondary|Change From Baseline in Clock-drawing Test|The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.|week 4, 12, 16, 24||||||
85886|NCT00947531|Secondary|Change From Baseline in Trail-making Test|The Trail-making test is a frequently used instrument for the assessment of executive function.|week 4, 12, 16, 24||||||
85887|NCT00947531|Secondary|Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)|The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver.|week 4, 12, 16, 24||||||
85888|NCT00947531|Secondary|Change From Baseline in MMSE (Mini-Mental State Examination) Score|The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer’s Disease. It evaluates orientation, registration, attention and calculation, recall and language.|week 4, 12, 16, 24||||||
85889|NCT00947531|Secondary|CIBIS+ (Clinicians Interview-Based Impression of Severity)|The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver.|week 24||||||
85890|NCT00947531|Secondary|CIBIC+ Response|A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders.|week 4, 12, 16, 24||||||
85891|NCT00947531|Secondary|CIBIC+ Sscore|The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver.|week 4, 12, 16||||||
85892|NCT00947531|Secondary|Change From Baseline for Original ADAS-COG|The Original Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.|week 4, 12, 16, 24||||||
85893|NCT00947531|Secondary|ADAS-COG+ Response|A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit.|week 4, 12, 16, 24||||||
85894|NCT00947531|Secondary|Change From Baseline in ADAS-COG+ (Alzheimer’s Disease Assessment Scale Cognitive Subpart)|The modified Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis.|week 4, 12, 16||||||
85895|NCT00947531|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram)||Baseline, week 4, 12, 16, 24||09/2009||||
85897|NCT00947531|Primary|Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24|The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.|baseline and week 24|The primary and confirmatory analysis is based on the ITT analysis set. The LOCF method is applied to account for missing data. The ITT analysis set consists of all randomized patients, who received at least one dose of study medication and had a baseline and at least one post-baseline assessment for both primary efficacy measures.||points on a scale||Standard Deviation|Mean
85898|NCT00947518|Secondary|Incidence of Clinical and Culture Positive Sepsis||First week of life.||09/2009||||
85899|NCT00947518|Primary|Number of Participants With Positive Skin Culture at Axilla|Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention|24 hours after intervention|||participants|||Number
85900|NCT00947518|Primary|Skin Temperature at 30 Min After Intervention|Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes|at 30 min after intervention|||Degree Celsius||Standard Deviation|Mean
85901|NCT00947518|Primary|Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al|The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)|At 24 hours|||score on a scale||Full Range|Median
85902|NCT00947427|Primary|C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|12 months|||nmol/L||95% Confidence Interval|Geometric Mean
85903|NCT00947349|Secondary|CL/F,ss for BI 201335 ZW|apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||mL/min||Geometric Coefficient of Variation|Geometric Mean
85904|NCT00947349|Secondary|Cavg for RBV|average plasma concentration (Cavg) of RBV|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85905|NCT00947349|Secondary|Cavg for BI 201335 ZW|average plasma concentration (Cavg) of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85906|NCT00947349|Secondary|Cmin,ss for RBV|Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85907|NCT00947349|Secondary|Cmin,ss for BI 201335 ZW|Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85908|NCT00947349|Secondary|t1/2,ss for BI 201335 ZW|terminal half-life of the analyte in plasma at steady state (t1/2,ss)|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||hour(s)||Geometric Coefficient of Variation|Geometric Mean
85909|NCT00947349|Secondary|Tmax, ss for RBV|Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||hour(s)||Full Range|Median
85910|NCT00947349|Secondary|Tmax, ss for BI 201335 ZW|Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS||hour(s)||Full Range|Median
85911|NCT00947349|Secondary|Tmax for RBV|Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS||hour(s)||Full Range|Median
85912|NCT00947349|Secondary|Tmax for BI 201335 ZW|Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS||hour(s)||Full Range|Median
85913|NCT00947349|Secondary|Cmax,ss of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85914|NCT00947349|Secondary|AUCτ,ss of RBV|Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
85915|NCT00947349|Secondary|Cmax of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
86031|NCT00946088|Secondary|Neonatal Intensive Care Unit (NICU) Admission||At time of neonatal discharge|||Participants|||Count of Participants
86032|NCT00946088|Secondary|Birthweight|Newborn birthweight in grams|At the time of newborn birth|||grams||Full Range|Mean
85917|NCT00947349|Secondary|AUCτ,1 for Ribavirin (RBV)|Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
85918|NCT00947349|Secondary|Cmax,ss of BI 201335 ZW|Maximum concentration of BI 201335 ZW at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85919|NCT00947349|Secondary|AUCτ,ss of BI 201335 ZW|AUC at steady state after 4 weeks combination of the last dose|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
85920|NCT00947349|Secondary|Cmax of BI 201335 ZW|Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
85921|NCT00947349|Secondary|AUCτ,1 for BI 201335 ZW|Area under the curve (AUC) concentration after the first dose of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
85922|NCT00947349|Secondary|Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV|An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.|44 weeks|TS||participant(s)|||Number
85923|NCT00947349|Secondary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.|44 weeks|TS||participant(s)|||Number
85924|NCT00947349|Secondary|Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV|Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|44 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.||participant(s)|||Number
85925|NCT00947349|Secondary|Sustained Virologic Response (SVR)|Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion|72 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85926|NCT00947349|Secondary|End of Treatment Response (ETR)|Number of patients with plasma HCV RNA level BLD at week 48|48 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85927|NCT00947349|Secondary|Complete Early Virological Response (cEVR)|Number of patients with plasma HCV RNA level BLD at Week 12|12 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85928|NCT00947349|Secondary|Early Virological Response (EVR)|Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12|12 Weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85929|NCT00947349|Secondary|Day 28 Virologic Response|Number of patients with HCV viral load reduction >= 2 log10 at Week 4|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85930|NCT00947349|Secondary|Change From Baseline in HCV Viral Load|Change form baseline in HCV viral load (log10) after 4 weeks|baseline and week 4|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||IU/mL||Standard Error|Mean
85931|NCT00947349|Secondary|Rapid Virological Response (RVR)|Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85932|NCT00947349|Secondary|Week 4 Virological Response (W4VR)|Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85933|NCT00947349|Secondary|Week 2 Virological Response (W2VR)|Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))|2 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.||participants|||Number
85934|NCT00947349|Primary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.||participants|||Number
85935|NCT00947349|Primary|Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation.||participants|||Number
85936|NCT00947310|Primary|Inappropriate ICD Therapy|First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)|Average of 1.4 years follow-up|||participants|||Number
85937|NCT00947310|Secondary|Syncope|First episode of syncope|Average of 1.4 years follow-up|||participants|||Number
85938|NCT00947310|Secondary|All-cause Mortality||Average 1.4 years of follow-up|||participants|||Number
85939|NCT00947297|Secondary|Patient Satisfaction With HPN-100|Drug preference will be noted at week 3|Month 1 post dose|all available questionnaires||% preferred HPN-100|||Number
85940|NCT00947297|Secondary|Blood Ammonia Levels|Venous Ammonia levels over time|1 Year|||Umol/L||Standard Deviation|Mean
85941|NCT00947297|Secondary|Number and Causes of Hyperammonemic Events|Number of hyperammonemic crises per patient|1 year|||hyperammonemic events||Standard Deviation|Mean
85942|NCT00947297|Primary|Rate of Adverse Events (Number of Participants Who Experienced Any AE Considered Related to Study Drug)||1 year|||participants|||Number
85943|NCT00947284|Primary|Change in Skin Sensitivity as Measured by a Visual Analog Scale|Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).|Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration|The planned model of skin irritation could not be reproduced on 3 enrolled participants, thus the investigator did not obtain outcome data.|||||
85944|NCT00947271|Primary|Number of Sexual Partners, 12 Months Post Intervention|number of sexual partners in the past 3 months, assessed 12 months post intervention|12 months post intervention|||number of partners||Standard Error|Least Squares Mean
85945|NCT00947271|Primary|Number of Sexual Partners, 9 Months Post Intervention|number of sexual partners in the past 3 months, assessed 9 months post intervention|9 months post intervention|||number of partners||Standard Error|Least Squares Mean
85946|NCT00947271|Primary|Number of Sexual Partners, 6 Months Post Intervention|number of sexual partners reported in the past 3 months, assessed 6 months post intervention.|6 months post intervention|||number of partners||Standard Error|Least Squares Mean
85947|NCT00947271|Secondary|Sexually Transmitted Infection Incidence|number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up|Measured throughout the 12 months post intervention|Participants who provided a urine sample for STI testing at any study follow up (3, 6, 9, or 12 months) OR who had STI testing performed at the STI clinic during the 12 months post intervention were included in these analyses||participants diagnosed with any STI|||Number
85948|NCT00947271|Primary|Number of Sexual Partners, 3 Months Post Intervention|number of sexual partners in the past 3 months, assessed 3 months post intervention|Measured after 3 months|||number of partners||Standard Error|Least Squares Mean
85949|NCT00947219|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|baseline, 16 and 26 weeks|||hairs per cm^2|Participants|Standard Deviation|Mean
85950|NCT00947154|Secondary|Clinical Global Impressions Improvement (CGI-I)|The CGI-I is a clinician rated scale ranging from 0 (not assessed) to 7 (very much worse), with intermediate scores of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse). The clinician is rating the overall change in the patient's clinical condition.|At week 8|11 participants. 1 participant lost to follow up after week 1||percentage completers with score 1 or 2|||Number
85951|NCT00947154|Primary|Mass General Hair Pulling Scale, Actual Pulling Subscale|Sum of scores for items 4, 5 and 6 from the Mass General Hair Pulling Scale (Frequency of Pulling, Attempts to Resist Pulling, Control Over Hair Pulling). Score can range from 0 to 12; higher scores indicate more severe hair pulling.|change from baseline to end of week 8|11 participants. 1 participant was lost to follow-up after week 1.||units on a scale||Standard Deviation|Mean
85952|NCT00947154|Secondary|CGI-I Score of 1 or 2 (Very Much or Much Improved)|CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better.|At week 8|11 of the 12 subjects initially enrolled. One subject was lost to follow-up after the baseline visit.||participants|||Number
85953|NCT00947154|Primary|Mass General Hair Pulling Scale|A brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess frequency and intensity of urges to pull, ability to control the urges, frequency of pulling, attempts to resist pulling, success in resisting, and associated distress. Statistical analyses indicate that the seven items form a homogenous scale for the measurement of severity in trichotillomania. Higher scores indicate greater severity of hair pulling. Total score can range from 0 to 28.|Change from baseline to week 8|11 of the 12 subjects initially enrolled. One was lost to follow-up after baseline visit.||units on a scale||Standard Deviation|Mean
85954|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 0 up to Year 10|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available throughout the study.||Subjects|||Number
86033|NCT00946088|Secondary|Maternal Anticipated Adverse Medication Reaction||Up to the maternal discharge from delivery hospitalization|||Participants|||Count of Participants
85955|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 (Year 9) to the Month 120 (Year 10) visit|The analysis was based on the Total Vaccinated cohort at Year 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 10.||Subjects|||Number
85956|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 (Year 8) to the Month 108 (Year 9) visit|The analysis was based on the Total Vaccinated cohort at Year 9, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 9.||Subjects|||Number
85957|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 (Year 7) to the Month 96 (Year 8) visit|The analysis was based on the Total Vaccinated cohort at Year 8, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 8.||Subjects|||Number
85958|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 (Year 6) visit to Month 84 (Year 7) visit|The analysis was based on the Total Vaccinated cohort at Year 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 7.||Subjects|||Number
85959|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit|The analysis was based on the Total Vaccinated cohort at Year 6, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 6.||Subjects|||Number
85960|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5)|The analysis was based on the Total Vaccinated cohort at Year 5, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 5.||Subjects|||Number
85961|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.||µg/mL||95% Confidence Interval|Geometric Mean
85962|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the Total Vaccinated Cohort at Years 5, 6 and 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.||µg/mL||95% Confidence Interval|Geometric Mean
85963|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL)|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||µg/mL||95% Confidence Interval|Geometric Mean
85964|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||µg/mL||95% Confidence Interval|Geometric Mean
85965|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||EL.U/mL||95% Confidence Interval|Geometric Mean
85966|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.||EL.U/mL||95% Confidence Interval|Geometric Mean
85967|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.||µg/mL||95% Confidence Interval|Geometric Mean
85968|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.||µg/mL||95% Confidence Interval|Geometric Mean
85969|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.||Subjects|||Number
85970|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.||Subjects|||Number
85971|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.||EU/mL||95% Confidence Interval|Geometric Mean
85972|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
85973|NCT00946985|Primary|Time to Relapse During Relapse Prevention Phase|Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.|24 months|The analysis population was to include all randomized patients who took at least one dose of study medication (ITT population). However, due to early study termination, only 2 patients were randomized and they did not have sufficient follow up. Hence the planned efficacy analysis could not be carried out.|||||
85974|NCT00946920|Secondary|Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline|"IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and a score of 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia."|At baseline, 1 month, 4 months, 7 months and 13 months|FAS.||units on a scale||Standard Deviation|Mean
85975|NCT00946920|Secondary|Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline|The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.|At baseline, 10 months and 13 months|FAS.||units on a scale||Standard Deviation|Mean
85976|NCT00946920|Secondary|Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time|Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.||percent change||Standard Deviation|Mean
85977|NCT00946920|Secondary|Serum Levels of Testosterone Over Time|Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.||ng/mL||Full Range|Median
85978|NCT00946920|Primary|Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin|This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.|Day 3 to Day 364|FAS.||percentage of participants||95% Confidence Interval|Number
86034|NCT00946088|Secondary|Maternal Chorioamnionitis||Up to maternal hospital discharge|||Participants|||Count of Participants
86035|NCT00946088|Primary|Reduction in Delivery Rate Prior to 37 Weeks Gestation|Reduction in delivery rate prior to 37 weeks gestation (preterm birth).|Up to 37 weeks of gestation|||Participants|||Count of Participants
85982|NCT00946348|Primary|fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).|Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.|Measures were acquired at peak THC level for each of the two drugs up to 4 hours.|||Z score||Standard Deviation|Mean
85983|NCT00946322|Secondary|Partner-reported Dyadic Adjustment Scale|Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed.||units on a scale||Standard Deviation|Mean
85984|NCT00946322|Secondary|Partner-reported Beck Depression Inventory - II|Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing the pre- and post-treatment assessment were included||units on a scale||Standard Deviation|Mean
85985|NCT00946322|Primary|Partner-reported PTSD Checklist|Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment||units on a scale||Standard Deviation|Mean
85986|NCT00946322|Primary|Patient-reported PTSD Checklist|Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were included.||units on a scale||Standard Deviation|Mean
85987|NCT00946322|Secondary|Patient-reported Dyadic Adjustment Scale|Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed||units on a scale||Standard Deviation|Mean
85988|NCT00946322|Secondary|Patient-reported Beck Depression Inventory - II (BDI-II)|Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.|Pre- to post-treatment|Participants completing the BDI-II at pre- and post-treatment were analyzed||units on a scale||Standard Deviation|Mean
85989|NCT00946322|Primary|Percentage Days of Heavy Drinking|Percentage days of heavy drinking (PDHD) was calculated by dividing the number of days in which the Veteran consumed more than six standard drinks by the total days in the period. Both partners reported upon the Veterans’ drinking behaviors. Following common practice in AUD research (e.g., McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2011), we used the highest report of the two regarding PDHD to reduce possible underreporting. Possible range of scores 0-100%. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were analyzed||percentage of days of heavy drinking||Standard Deviation|Mean
85990|NCT00946322|Primary|Clinician-administered PTSD Scale (CAPS)|Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.|Pre- to post-treatment (~20 weeks)|Participants completing both pre- and post-treatment assessments were analyzed.||units on a scale||Standard Deviation|Mean
85991|NCT00946309|Primary|3-alpha-diol Gluconate Levels|Change in serum 3-alpha-diol gluconate(3α-DG) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants||ng/mL||Standard Deviation|Mean
85992|NCT00946309|Primary|Testosterone Levels|Change in testosterone (T) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants||ng/dL||Standard Deviation|Mean
85993|NCT00946309|Primary|DHT Levels|Change in serum dihydrotestosterone (DHT) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants||pg/mL||Standard Deviation|Mean
85994|NCT00946309|Primary|DNA Oxidation|Prostate tissue 8-hydroxy-2’-deoxyguanosine (8OHdG) levels|Five weeks|Outcome data were not collected due to budget restrictions|||||
85995|NCT00946309|Primary|Lipid Oxidation|Blood F2 Isoprostane levels|Baseline and 5 weeks|Outcome data were not collected due to budget restrictions|||||
85996|NCT00946309|Primary|Gene Expression of Phase II Enzymes|Change in Phase II enzyme expression|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 20 participants||-fold change in expression||Standard Deviation|Mean
85997|NCT00946296|Primary|Blood Loss During Surgery|Blood loss in milliliters during surgery.|up to 162 minutes|||mL||Standard Deviation|Mean
85998|NCT00946114|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.|Baseline up to 116 Weeks|Safety population: all subjects assumed to have taken at least one dose of study medication. Non-serious adverse events were reported up to 7 days after the last dose of study medication. Serious adverse events were reported up to 28 days after the last dose of study medication.||participants|||Number
85999|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).||titer||Full Range|Geometric Mean
86000|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).||titer||Full Range|Geometric Mean
86036|NCT00945958|Secondary|Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)|From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured|24 weeks|From the start of the study through Week 24 (Visit 7, End of Evaluations), the change in IOP is evaluated||mm Hg||Standard Deviation|Mean
86001|NCT00946101|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).||titer||Full Range|Geometric Mean
86002|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).||participants|||Number
86003|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).||participants|||Number
86004|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).||participants|||Number
86005|NCT00946101|Secondary|Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86006|NCT00946101|Secondary|Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||Participants|||Number
86007|NCT00946101|Secondary|Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
86008|NCT00946101|Secondary|Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
86009|NCT00946101|Secondary|Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86010|NCT00946101|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86037|NCT00945958|Primary|Number of Subjects With AEs|Subjects with treatment emergent adverse events|24 weeks|||participants|||Number
86013|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).||participants|||Number
86014|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
86015|NCT00946101|Secondary|Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo) and experienced any follow-up for safety (H1N1=255; Placebo=63).||participants|||Number
86016|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).||participants|||Number
86017|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86018|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86019|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety, and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).||participants|||Number
86020|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86021|NCT00946101|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86022|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1|Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.|Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).||participants|||Number
86023|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).||participants|||Number
86024|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).||participants|||Number
86025|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).||participants|||Number
86026|NCT00946101|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.|Days 1- 8|The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).||participants|||Number
86027|NCT00946088|Secondary|Number of Days Delay of Delivery|Number of days from intervention to delivery|Up to the time of delivery|exact delivery data unavailable for one term participant||days||Full Range|Median
86028|NCT00946088|Secondary|Neonatal Congenital Abnormalities||Up to the time of neonatal discharge from the delivery hospital|||Neonates|||Number
86029|NCT00946088|Secondary|Neonatal Mortality||Up to 28 days after neonatal birth|||Participants|||Count of Participants
86030|NCT00946088|Secondary|Neonatal Morbidity||Up to 28 days after neonatal birth|||Participants|||Count of Participants
86038|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in 36-item Short-Form Health Survey|Self-reported questionnaire with 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86039|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D)|Patients rate their health state in 5 domains: mobility, self-care, usual activities, pain, and mood. Score between 1-3 is generated for each domain which is mapped to single index score. Index ranges between 0-1; higher scores indicate better health perceived by patient. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86040|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS)|BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0-20. Total score = sum of all factor scores minus vigor score. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86041|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version|An 11-item questionnaire to individually and jointly assess intermittent and constant pain. Questions assess intensity and impact of pain on activity and emotion. Each item is scored from 0 to 4; higher values indicate higher severity. Total Pain score ranges from 0-44. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86042|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86043|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score|Interference scores range from 0 (does not interfere) to 10 (completely interferes) on 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Total score ranges from 0-70. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86044|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale|Self-reported scale measuring pain severity. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Four questions assess worst pain, least pain, and average pain in the past 24 hours, and pain right now. Total score ranges from 0-40. Due to the nature of a study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86045|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score|The WOMAC index (pain, stiffness, physical function subscales) was completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|baseline, 13 weeks|||units on a scale||Standard Deviation|Mean
86046|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks|||participants||Standard Deviation|Mean
86047|NCT00945945|Secondary|Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale|C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors and ideations are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.|Baseline through 13 weeks|All randomized participants.||participants|||Number
86048|NCT00945945|Primary|"Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented.|Baseline, 13 weeks|Number of randomized participants with a non-missing baseline and BOCF endpoint.||units on a scale||Standard Deviation|Mean
86049|NCT00945906|Secondary|Number of Bleeding Episodes|Number of bleeding episodes at any time after the first infusion in the study.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||Episodes|||Number
86050|NCT00945906|Secondary|Number of Subjects With at Least One Bleeding Episode|Number of subjects with at least one bleeding episode at any time after the first infusion in the study, and the number of subjects with at least one bleeding episode requiring Factor XIII treatment.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||participants|||Number
86051|NCT00945906|Secondary|FXIII Concentration|Trough Factor XIII concentration.|Before the first infusion, at 24 and 48 weeks after the first infusion, and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||Units/mL||Standard Deviation|Mean
86052|NCT00945906|Secondary|FXIII Antibody Testing|Number of participants with serum Factor XIII antibodies.|Before the first infusion, then every 48 weeks, at the end-of-study (or withdrawal) visit and after a bleeding episode requiring treatment with a Factor XIII -containing product.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||participants|||Number
86053|NCT00945906|Secondary|Hematology and Chemistry Testing|Number of participants with treatment-emergent clinically significant hematology and/or chemistry laboratory parameter values.|After the first infusion and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.||participants|||Number
86054|NCT00945906|Primary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment-related AEs are defined as AEs whose relationship to treatment is related, or possibly related and AEs with missing relationship.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study. Treatment related AEs are events whose relationship to study treatment is related, or possibly related, in the opinion of the investigator. AEs with missing relationship are considered related to treatment.||participants|||Number
86055|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.||Titer||Full Range|Geometric Mean
86056|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Titer||Full Range|Geometric Mean
86057|NCT00945893|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Titer||Full Range|Geometric Mean
86058|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.||Participants|||Number
86059|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
86060|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
86076|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.||Days 1-8|The Safety population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86061|NCT00945893|Secondary|Number of Participants With NOCDs Through 180 Days Post Final Dose.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86062|NCT00945893|Secondary|Number of Participants With SAEs Through 180 Days Post Final Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86063|NCT00945893|Secondary|Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.||Participants|||Number
86064|NCT00945893|Secondary|Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
86065|NCT00945893|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86066|NCT00945893|Secondary|Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86067|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
86068|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
86069|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.||Participants|||Number
86070|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
86071|NCT00945893|Secondary|Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.||Participants|||Number
86072|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2||Days 29-36|The Safety Population for solicited symptoms dose 2 was defined as all participants who received Dose 2, had any follow-up for safety and had solicited symptom data available during the reporting period.||Participants|||Number
86073|NCT00945893|Secondary|Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86074|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86075|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.||Participants|||Number
86078|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1|Solicited symptoms were events considered likely to occur post dosing. For this study, other solicited symptoms included: Fever (> 100°F [37.8°C] oral), Runny nose, Sore throat, Cough, Vomiting, Muscle aches, Chills, Decreased activity (tiredness), and Headache.|Days 1-8|The Safety population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.||Participants|||Number
86079|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.||Participants|||Number
86080|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 29|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
86081|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 15|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.||Participants|||Number
86082|NCT00945893|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses • H0 (null): rate difference ≥ 10% • HA (alternative): rate difference < 10%|Days 1-8|Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.||Participants|||Number
86083|NCT00945854|Secondary|Postprandial Plasma Lipid Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of triglyceride response reported as average mean postprandial increment.|12 weeks|||mg/dlx3hrs||Standard Deviation|Mean
86084|NCT00945854|Secondary|Postprandial Insulin Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of plasma insulin response reported as average mean postprandial increment.|12 weeks|||(microU/mlx3hrs)||Standard Deviation|Mean
86085|NCT00945854|Primary|Insulin Sensitivity (Si)|Peripheral insulin sensitivity was assessed by FSIGT. A glucose dose of 300 mg/kg body weight was given intravenously followed by a bolus of 0.03 U/kg of insulin injected after 20 min. Blood samples were frequently collected for 3 h for the measurement of plasma glucose and serum insulin concentrations, utilized to calculate the insulin sensitivity index Si|12 weeks|||104xmin-1/microU/ml||Standard Error|Mean
86086|NCT00945815|Primary|Complete Remission|Complete remission (CR) is defined as: <5% marrow aspirate blasts. Blasts can be >=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils >= 1000/mcl; platelets >100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be <=100,000/mcl and/or ANC may be <1,000/mcl.|After induction therapy was completed (1 or 2 months)|Eligible patients who began protocol therapy.||percentage of participants||95% Confidence Interval|Number
86087|NCT00945815|Secondary|Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries.||Participants|||Number
86088|NCT00945750|Secondary|Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL||95% Confidence Interval|Geometric Mean
86089|NCT00945750|Secondary|AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL hr||95% Confidence Interval|Geometric Mean
86090|NCT00945750|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL||95% Confidence Interval|Geometric Mean
86130|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||logMAR||Standard Deviation|Mean
86091|NCT00945750|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study||ng/mL hr||95% Confidence Interval|Geometric Mean
86092|NCT00945555|Secondary|Percentage of Participants Who Had a Treatment Modification||Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants who had a treatment modification at any time point. n=number of participants who had data available at that specific time point.||percentage of participants|||Number
86093|NCT00945555|Secondary|Percentage Survivors||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with data available.||percentage of participants|||Number
86094|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined at End of Treatment||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed = number of participants with new infection diagnosed at end of treatment.||percentage of participants|||Number
86095|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined on Day 4||Day 4|All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4.||percentage of participants|||Number
86096|NCT00945555|Secondary|Mean Neutrophil Count||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with available data. n=number of participants with data available at that time point.||neutrophils per cubic millimeter||Standard Deviation|Mean
86097|NCT00945555|Secondary|Mean Body Temperature||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. n=number of participants with available data at that time point.||Degree Celsius||Standard Deviation|Mean
86098|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted||Baseline|All participants enrolled in the study who received treatment for febrile neutropenia. Number of participants analyzed=number of participants who received an antibacterial drug for the treatment of febrile neutropenia. Participants may be counted more than once because they may have received more than one antibacterial agent.||percentage of participants|||Number
86099|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical||Baseline|All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent.||percentage of participants|||Number
86100|NCT00945477|Secondary|Number Adverse Events, Grades 1-5 Using NCI-CTCAE v 3.0|Safety was evaluated by documentation of Adverse Events (AEs), by assessment of clinical laboratory findings, and by physicial examination, including measurement of vital signs and weight in all eleven subjects.|0-12 weeks|The adverse events for all participants enrolled were evaluated by documentation of Adverse Events (AEs)Grades 1-5 using NCI-CTCAE v 3.0||Adverse events Grade 1-5|||Number
86101|NCT00945477|Primary|Response Rate at 12 Weeks|Response rate defined as 50% decrease in the Prostate Specific Antigen (PSA) level at week 12 compared to baseline|12 weeks|Five subjects completed the 12 week treatment requirement.||participants|||Number
86102|NCT00945334|Secondary|Change in Methane From Baseline|"Methane output was reported as methane in parts per million (ppm) on breath test:~Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration."|Baseline (Day 0) and Final Visit (Day 44)|Change in breath test methane gas levels: baseline breath test minus final breath test measurement.||parts per million||Standard Deviation|Median
86103|NCT00945334|Primary|Severity of Constipation in Each Arm at Week 1 After Completion of Therapy|"Visual analog scale (VAS) score for constipation:~Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms)."|1 year|||units on a scale||Standard Deviation|Mean
86104|NCT00945321|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.||ng/mL||Standard Error|Mean
86105|NCT00945321|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.||ng•hr/mL||Standard Deviation|Mean
86106|NCT00945295|Secondary|Length of Time to Meet Re-injection Criteria and the Number of Participants That do Not Meet Re-injection Criteria Prior to Completion of the Study.||6 Weeks|||number|||Number
86107|NCT00945295|Primary|The Maximum Change in Fugl-Meyer Upper Extremity Score From the Baseline Exam to Any Post Injection Visit in Each Treatment Arm. Comparison of the Difference Scores Between the Two Groups Will be Considered Significant at p < 0.05.||6 Weeks|||difference|||Number
86108|NCT00945256|Primary|Mixed Muscle Fractional Synthesis Rate (FSR)|The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.|Acute ( 8 hours)|FSR was not calculated for the Elderly Sodium Nitroprusside with Amino Acid Drink arm of the study.||Fractional Synthesis Rate (pecent/hour)||Standard Error|Mean
86112|NCT00945139|Primary|Progression Free Survival (PFS) by GCIC Criteria|Using GCIC criteria, progression is defined as CA-125 levels greater than, or equal to, 2 times the upper limit of a reference range on 2 occasions and at least 1 week apart.|Up to 25 months|28 out of 46 enrolled patients were assessable for PFS per GCIC criteria. The remaining patients could not be evaluated for this endpoint because the timing of their CA-125 measurements did not meet the defined criteria.||Months||95% Confidence Interval|Median
86113|NCT00945139|Secondary|Overall Response Rate (ORR) by GCIC Criteria|A response according to GCIC criteria has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment.|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||percentage of participants||95% Confidence Interval|Number
86114|NCT00945139|Secondary|Clinical Benefit Rate (by RECIST)|Clinical Benefit Rate (CBR) is the sum of the percentages of patients achieving complete response, partial response, and stable disease. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||percentage of participants||95% Confidence Interval|Number
86115|NCT00945139|Secondary|Overall Response Rate (ORR) by RECIST|ORR is the sum of the percentages of patients achieving complete and partial responses. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0)|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||Percentage of participants||95% Confidence Interval|Number
86116|NCT00945139|Secondary|Overall Survival|The time from treatment initiation to death by any cause|4 years|||Months||Full Range|Median
86117|NCT00945139|Primary|Progression Free Survival (PFS) by RECIST Criteria|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by hysical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 25 months|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.||Months||Full Range|Median
86118|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with anisometropic amblyopia (no strabismus) who had measureable stereoacuity at randomization and at the 10-week primary outcome exam.||participants|||Number
86119|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia||10 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.||participants|||Number
86120|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia||Randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.||participants|||Number
86121|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with measureable stereoacuity at randomization and at the 10-week primary outcome exam.||participants|||Number
86122|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks||10 weeks after randomization|The analysis includes all participants who completed the 10-week exam.||participants|||Number
86123|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization|"The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800.~We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing.~The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank."|Randomization|The analysis includes all participants who completed the 10-week exam.||participants|||Number
86124|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later|||logMAR lines||Standard Deviation|Mean
86125|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
86126|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||logMAR lines||Standard Deviation|Mean
86132|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained.|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
86133|NCT00945100|Secondary|Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR lines||Standard Deviation|Mean
86134|NCT00945100|Secondary|Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
86135|NCT00945100|Secondary|Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR||Standard Deviation|Mean
86136|NCT00945100|Secondary|Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
86137|NCT00945100|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||units on a scale||Standard Deviation|Mean
86138|NCT00945100|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||logMAR||Standard Deviation|Mean
86139|NCT00945100|Primary|Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR lines||Standard Deviation|Mean
86140|NCT00945100|Primary|Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
88719|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mmHg||Standard Deviation|Mean
86141|NCT00945100|Primary|Mean 10-week Amblyopic Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR||Standard Deviation|Mean
86142|NCT00945100|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
86143|NCT00945100|Secondary|Treatment Group Comparison of 10-week Interocular Difference|The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||logMAR lines||Standard Deviation|Mean
86144|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
86145|NCT00945100|Secondary|Average Compliance With Prescribed Patching by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization or later|||participants|||Number
86146|NCT00945100|Secondary|Compliance With Prescribed Patching by Treatment Group at 10 Weeks|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization|||participants|||Number
86147|NCT00945100|Primary|Distribution of 10-week Amblyopic Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
86148|NCT00945035|Primary|Peak Plasma Concentration (Cmax) for Etoricoxib||Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.||ng/mL||Standard Deviation|Least Squares Mean
86149|NCT00945035|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib|The area under the plasma concentration vs time curve.|Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.||µg times hr/mL||Standard Deviation|Least Squares Mean
86150|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia||12 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 12-week exam.||participants|||Number
86151|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of >800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.|12 weeks after randomization|The analysis includes all participants who completed the 12-week exam.||participants|||Number
86152|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit||10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|||participants|||Number
86177|NCT00944671|Secondary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng/mL||95% Confidence Interval|Geometric Mean
86153|NCT00944710|Secondary|Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR lines||Standard Deviation|Mean
86154|NCT00944710|Secondary|Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
86155|NCT00944710|Secondary|Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||logMAR||Standard Deviation|Mean
86156|NCT00944710|Secondary|Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.||participants|||Number
86157|NCT00944710|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||logMAR lines||Standard Deviation|Mean
86158|NCT00944710|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.||logMAR||Standard Deviation|Mean
86159|NCT00944710|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
86160|NCT00944710|Secondary|Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization|||change in lines||Standard Deviation|Mean
86161|NCT00944710|Secondary|Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization|||participants|||Number
86162|NCT00944710|Secondary|Mean Fellow-Eye Visual Acuity at 12-week Exam||12 weeks after randomization|||logMAR||Standard Deviation|Mean
86163|NCT00944710|Secondary|Distribution of 12-week Fellow-Eye Visual Acuity|Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.|12 weeks after randomization|||participants|||Number
86164|NCT00944710|Secondary|Mean Interocular Difference at 12-week Exam|Mean Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization|||logMAR lines||Standard Deviation|Mean
86165|NCT00944710|Secondary|Distribution of Interocular Difference at 12-week Exam|Distribution of Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization|||participants|||Number
86166|NCT00944710|Primary|Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR lines||Standard Deviation|Mean
86167|NCT00944710|Primary|Distribution of the Change in Amblyopic-Eye Visual Acuity|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
86168|NCT00944710|Primary|Mean 10-week Amblyopic-Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||logMAR||Standard Deviation|Mean
86169|NCT00944710|Secondary|Average Atropine Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|||participants|||Number
86170|NCT00944710|Secondary|Atropine Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization|||participants|||Number
86171|NCT00944710|Secondary|Average Spectacle Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|||participants|||Number
86172|NCT00944710|Secondary|Spectacle Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization|||participants|||Number
86173|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.||participants|||Number
86174|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization|"The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.||participants|||Number
86175|NCT00944710|Primary|Distribution of 10-week Amblyopic-Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.||participants|||Number
86176|NCT00944697|Primary|Short Form McGill Pain Score.|The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B – rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain.|Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)|||units on a scale||Standard Deviation|Mean
86178|NCT00944671|Secondary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng*h/mL||95% Confidence Interval|Geometric Mean
86179|NCT00944671|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng/mL||95% Confidence Interval|Geometric Mean
86180|NCT00944671|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)|||ng*hr/mL||95% Confidence Interval|Geometric Mean
86181|NCT00944645|Primary|Maximum Concentration (Cmax) of Laropiprant|Measure of rate of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant Cmax and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet.||micro Molar||Standard Deviation|Median
86182|NCT00944645|Primary|Area Under Curve (AUC 0-infinity) of Laropiprant|Measure of extent of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant AUC0-infinity and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet||Micro Molar times Hour||Standard Deviation|Median
86183|NCT00944645|Primary|Total Amount of Urinary Excretion of Niacin and Its Metabolites|Measure of extent of absorption of ER niacin|Predose and up to 96 hours postdose|A linear mixed effect model was used to analyze total amount of urinary excretion of niacin and its metabolite and uses data available from at least one treatment period. 157 subjects had data from the treatment of MK0524A New Site Tablet, and 161 subjects had data from the treatment of MK0524A Phase III Tablet||micro mole||Standard Deviation|Median
86184|NCT00944645|Primary|Maximum Plasma Concentration (Cmax) of Nicotinuric Acid|Measure of rate of absorption of ER niacin|Predose and up to 24 hours postdose|The Hodges-Lehmann estimator was used to analyze nicotinuric acid Cmax and uses only subjects with data available on both treatment periods. 188 subjects were randomized,17 subjects discontinued, 26 subjects were inadvertently overdosed with 5 tablets of MK0524A 1000 mg/20 mg, reducing the available subject population for analysis to 145.||ng/mL||Inter-Quartile Range|Median
86185|NCT00944450|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects||μmol/L||Standard Deviation|Geometric Mean
86186|NCT00944450|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects||μmol*hr/L||Standard Deviation|Geometric Mean
86187|NCT00944229|Primary|Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.|||||
86188|NCT00944229|Primary|Change in Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) After 8 Weeks of Omega 3 Supplementation.||0 and after 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.|||||
86189|NCT00944229|Primary|Change in Peak VO2||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.|||||
86190|NCT00944125|Primary|Change in Left Ventricular End Systolic Volume (LVESV)|The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.|At 6 months to one year|Analysis population was based on the two randomized groups per the protocol.||ml||Standard Deviation|Mean
86191|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86226|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86192|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86193|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86194|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86195|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86196|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86197|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86198|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86216|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86199|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86200|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86201|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 8-10 and 21 after first vaccination|All participants with blood collected at the timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86202|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86203|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86204|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.||Participants|||Number
86205|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86206|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination|All participants with blood collected at baseline and with at least one evaluable time point after vaccination are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86252|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Intent to treat analysis||percent change||Standard Deviation|Mean
86207|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|All participants with blood collected at the timepoint within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86208|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86209|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86210|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|Participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.||Participants|||Number
86211|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86212|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86213|NCT00944073|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86214|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86215|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86253|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Per protocol analysis - Only subjects with values at baseline and Week 24 endpoint are included.||percent change||Standard Deviation|Mean
86254|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 12|Day 0 to Week 12|Intent to treat analysis||percent change||Standard Deviation|Mean
86217|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86218|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86219|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86220|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86221|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86222|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86223|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86224|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86225|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86255|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c over first 12 weeks (Stage I)|Day 0 and Week 12|Per protocol analysis- Only subjects with values at baseline and Week 12 endpoint are included.||percent change||Standard Deviation|Mean
86227|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86228|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|day 1 to day 7 after vaccination|The analysis was done on safety population||participants|||Number
86229|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the Safety Population.||participants|||Number
86230|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA|1 month after booster vaccination|The analysis was performed on the per-protocol population||IU/mL||95% Confidence Interval|Geometric Mean
86231|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.|1 month after booster vaccination|The analysis was performed on the per-protocol population||IU/mL||95% Confidence Interval|Geometric Mean
86232|NCT00944034|Secondary|Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months|Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after second vaccination|The analysis was performed on the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
86233|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)||Titers||95% Confidence Interval|Geometric Mean
86234|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
86235|NCT00944034|Secondary|Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.|The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)||Titers||95% Confidence Interval|Geometric Mean
86236|NCT00944034|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.|1 month after booster|The analysis was performed on the per-protocol population||percentage of subjects||95% Confidence Interval|Number
86433|NCT00943436|Primary|Percent Energy From Protein at the Meal (Exercise Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
86237|NCT00944034|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.|Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.|1 month after booster|||percentage of subjects||95% Confidence Interval|Number
86238|NCT00944034|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.|1 month after booster|The analysis was performed on the per-protocol population||percentage of subjects||95% Confidence Interval|Number
86239|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24 and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||hour||Standard Deviation|Mean
86240|NCT00944021|Secondary|Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12,16, 24, and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||ng/mL||Standard Deviation|Mean
86241|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||hours||Standard Deviation|Mean
86242|NCT00944021|Secondary|Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||ng * hour/mL||Standard Deviation|Mean
86243|NCT00944021|Secondary|Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.||ng/mL||Standard Deviation|Mean
86244|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.||hours/day||Standard Deviation|Mean
86245|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.||hours/day||Standard Deviation|Mean
86246|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).||Fourteen consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.||hours/day||Standard Deviation|Mean
86247|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10CFU/ml/day||Standard Deviation|Mean
86248|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10CFU/ml/day||Standard Deviation|Mean
86249|NCT00944021|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).||14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.||log10CFU/ml/day||Standard Deviation|Mean
86250|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Intent to treat analysis||percent change||Standard Deviation|Mean
86251|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Per protocol - Only subjects with values at baseline and Week 48 endpoint are included.||percent change||Standard Deviation|Mean
86256|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.||Participants|||Number
86257|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.||Participants|||Number
86258|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.||Participants|||Number
86259|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
86260|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
86261|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.||Participants|||Number
86262|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.||Participants|||Number
86263|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.||Participants|||Number
86264|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
86265|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.||Participants|||Number
86266|NCT00943878|Primary|Number of Participants Reporting Fever After the Third Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
86267|NCT00943878|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
86268|NCT00943878|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.||Participants|||Number
86269|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination are included. Analyses are as treated.||Participants|||Number
86270|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.||Participants|||Number
86271|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86272|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86273|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86274|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86275|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.||Participants|||Number
86344|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero extrapolated to infinity (AUCinf) for T-DM1 (conjugated trastuzumab) and total trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycle 1.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||μg * day/mL||Standard Deviation|Mean
86276|NCT00943878|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86277|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86278|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86279|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86280|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86281|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86282|NCT00943878|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86283|NCT00943878|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86284|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86285|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo|"The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P =~pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline."|Baseline and 10 hours postdose|All subjects who received single doses of Losartan 100 mg + ISMN 60 mg and/or single dose of placebo||Percent Change||Standard Deviation|Least Squares Mean
86286|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg|The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.|Baseline and 10 hours postdose|All subjects who received single doses of losartan 100 mg + ISMN 60 mg and/or single dose of losartan 100 mg||Percent Change||Standard Deviation|Least Squares Mean
86287|NCT00943826|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|Until data cutoff= 31 March 2012 (up to 34 months)|Safety Population included all randomized participants who received study treatment during the study treatment period. Twelve of the patients randomized to the Placebo + RT + Temozolomide arm received at least one dose of bevacizumab and were added to the Bevacizumab + RT + Temozolomide arm for Safety.||Participants|||Number
86288|NCT00943826|Secondary|Duration of Stable/Improved Health Related Quality of Life (HRQoL) Using the European Organisation for Research and Treatment of Cancer Scales (EORTC) QLQ-C30 and BN20|Stable and Improved HRQoL during PFS time was determined using the EORTC QLQ-C30 and BN20 questionnaires. The EORTC QLQ-C30 is a 30-item self-reported questionnaire in 5 functional scales (physical,role,emotional,cognitive,social), 3 symptoms scales, 6 single-item measures and a global health status/QoL scale.Patients rated the items on a 4-point scale: 1=not at all to 4=very much.Global health status/QoL items were rated on a 7-point scale: 1=very poor to 7=excellent. The BN20 consisted of 20 questions in 4 scales(future uncertainty,visual disorder,motor dysfunction,communication deficit) and 7 single-item measures rated on a 4-point scale: 1=not at all to 4=very much. A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100. Stable HRQoL was defined as a change from baseline within 10 points.Improved HRQoL is defined as an increase of at least 10 points for functioning/global health status and a decrease of at least 10 points for symptoms.|Randomization until Progressive Free Survival Event [Until data cutoff= 31 March 2012 (up to 34 months)]|Intent to treat population included all randomized participants.||Months||Full Range|Median
86289|NCT00943826|Secondary|Percentage of Participants With Two-year Survival|Percentage of participants who are still alive 2 years post randomization.|2 years||02/2016||||
86290|NCT00943826|Secondary|Percentage of Participants With One-Year Survival|Percentage of participants who are still alive 1 year post randomization.|1 year|Intent to treat participants included all randomized participants.||Percentage of participants|||Number
86291|NCT00943826|Secondary|Progression-free Survival (PFS) as Assessed by an Independent Review Facility|An Independent Review Facility reviewed the magnetic resonance imaging (MRI) scans used by the investigator to evaluate radiological tumor response. PFS was defined as the time from randomization to disease progression or death due to any cause.|Randomization until Progressive Free Survival Event [Until data cutoff= 31 March 2012 (up to 34 months)]|Intent to treat population included all randomized participants.||Months||95% Confidence Interval|Median
86292|NCT00943826|Primary|Co-Primary: Overall Survival (OS)|Overall Survival was defined as the time from randomization to death due to any cause.|Randomization until Overall Survival Event||02/2016||||
86293|NCT00943826|Primary|Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator|"PFS was defined as the time from randomization to disease progression or death due to any cause.~Disease progression (PD) was assessed by the investigator using adapted Macdonald response criteria (modified World Health Organization (WHO) criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging (MRI) scans, neurological assessment and changes in corticosteroid use.~PD was determined as ≥ 25% increase in the sum of the products of the perpendicular longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir) during the study or unequivocal progression of existing non-index lesions (non-enhancing and enhancing, non-measurable) or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) with no need for a confirmatory scan.~Data from the final analysis is presented."|Randomization until Progressive Free Survival Event [Until data cutoff= 31 March 2012 (up to 34 months)]|Intent to treat population included all randomized participants.||Months||95% Confidence Interval|Median
86294|NCT00943787|Secondary|Maximum Epinephrine Response (ADRR Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.~Average Daily Risk Range (ADRR) is associated with glycemic variability and risk of both hyper- and hypoglycemia.~Low Risk, ADRR < 20; Moderate Risk, 20 < ADRR < 40; and High Risk,ADRR > 40."|285 min (time of clamp)|3 participants did not have enough epinephrine data||pg/ml||Standard Deviation|Mean
86295|NCT00943787|Primary|Maximum Epinephrine Response (LBGI Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.~Low blood glucose index (LBGI) is a metric to calculate the risk for hypoglycemia based on frequency and extent of past events based on SMBG readings. In studies, the LBGI typically accounted for 40–55% of the variance of future significant hypoglycemia in the subsequent 3–6 months. The LBGI has established risk categories: Low Risk, LBGI < 2.5; Moderate Risk, 2.5 < LBGI < 5; and High Risk, LBGI > 5, indicating an over 10-fold increase in future severe hypoglycemia from the lowest to the highest risk category."|285 min (time of clamp)|3 participants did not have adequate epinephrine data.||pg/ml||Standard Deviation|Mean
86296|NCT00943761|Primary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)|SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.|72 weeks|Population includes only a subset of participants previously treated with placebo + peg-IFN + RBV in a vaniprevir study and excludes participants for failure to receive >=1 dose of study drug, lack of any post-allocation endpoint data subsequent to >=1 dose of study drug, lack of baseline data, or missing data due to discontinuation from the study||Percentage of participants||95% Confidence Interval|Number
86297|NCT00943761|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|48 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.||Participants|||Number
86298|NCT00943761|Primary|Number of Participants Who Experienced a Serious Adverse Event|Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.||Participants|||Number
86299|NCT00943761|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.||Participants|||Number
86300|NCT00943735|Secondary|Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview||Enrollment (Day 0) up to 90 days|PP population; (n)=CATI response valid n at observation. Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid n, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86301|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86302|NCT00943735|Secondary|Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86303|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With Their Physician||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86517|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 209 and 210 subjects were available for simvastatin Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL||Standard Deviation|Least Squares Mean
86304|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers|"Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86305|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86306|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86307|NCT00943735|Secondary|Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86308|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86309|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors|The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86310|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Learned Something About Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86311|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)|Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86312|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86313|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86323|NCT00943735|Secondary|Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms|The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86314|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86315|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86316|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86317|NCT00943735|Secondary|Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan|Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit. Follow-up visits could be scheduled per standard clinical practice.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86318|NCT00943735|Secondary|Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary|"For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86319|NCT00943735|Secondary|Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker|"YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to wait), daily Toviaz® (always take as directed), and keep track (share with your doctor)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86320|NCT00943735|Secondary|Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86321|NCT00943735|Secondary|"Percentage of Participants Who Reported That They Trained Their Bladder to Wait"|"The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating I'm the boss - not my bladder)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86322|NCT00943735|Secondary|Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices|The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86342|NCT00943670|Secondary|Clearance T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||mL/day/kg||Standard Deviation|Mean
86324|NCT00943735|Secondary|Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit|YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form. About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for “Core 4” elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and “track your progress” brochure; and recipes using bladder-friendly foods.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86325|NCT00943735|Secondary|Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86326|NCT00943735|Secondary|Percentage of Participants Who Visited the YourWay Website|YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component. Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants’ Overactive Bladder (OAB) outcomes. Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.||percentage of participants||95% Confidence Interval|Number
86327|NCT00943735|Secondary|Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice. The first refill indicated that 2 fesoterodine prescriptions had been filled.|Enrollment (Day 0) up to 90 days|PP population||percentage of participants||95% Confidence Interval|Number
86328|NCT00943735|Secondary|Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.|Enrollment (Day 0) up to 90 days|PP population||percentage of participants||95% Confidence Interval|Number
86329|NCT00943735|Primary|Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment|Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.|Enrollment (Day 0) up to 90 days|Per Protocol (PP) population: all participants who returned a signed informed consent form (Intent to Treat) and enrollment questionnaire, had evidence of ≥1 prescription in LRx database for any medication class, and did not receive an initial fesoterodine prescription for ≥ a 90-day supply.||percentage of participants||95% Confidence Interval|Number
86330|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post- vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||Percentage of Participants||95% Confidence Interval|Number
86331|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||Percentage of Participants||95% Confidence Interval|Number
86343|NCT00943670|Secondary|Terminal Half-life for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||days||Standard Deviation|Mean
86332|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||Percentage of Participants||95% Confidence Interval|Number
86333|NCT00943722|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.||Percentage of Participants|||Number
86334|NCT00943722|Primary|Percentage of Participants With Systemic AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.||Percentage of Participants|||Number
86335|NCT00943722|Primary|Percentage of Participants With Injection Site Adverse Experiences (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.||Percentage of Participants|||Number
86336|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
86337|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
86338|NCT00943722|Primary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
86339|NCT00943683|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|During the 6 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
86340|NCT00943670|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATAs) to Trastuzumab Emtansine|The number of participants with anti-T-DM1 antibodies was assessed using a validated bridging antibody enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|Evaluable patients, defined as patients who had at least one ATA measurement available for analysis at Baseline (pre-dose in Cycle 1) and post-baseline.||participants|||Number
86341|NCT00943670|Secondary|Volume of Distribution at Steady State for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||mL/kg||Standard Deviation|Mean
86724|NCT00940485|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48|Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
86345|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero to time of last measurable concentration (AUClast) for T-DM1 (conjugated trastuzumab) and Total Trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1 and Cycle 3.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||μg * day/mL||Standard Deviation|Mean
86346|NCT00943670|Secondary|Maximum Observed Serum Concentration of T-DM1 and Total Trastuzumab|Serum samples were quantitated for T-DM1 (DM1 conjugated to trastuzumab) levels in a validated assay using an indirect sandwich enzyme-linked immunosorbent assay (ELISA). The minimum quantifiable concentration in human serum was 40 ng/mL. Serum samples were assayed for total trastuzumab (conjugated and unconjugated T-DM1) in a validated assay using an indirect sandwich ELISA method; the minimum quantifiable concentration in human serum was 40 ng/mL.|Blood samples were collected prior to dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"Pharmacokinetic (PK)-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."||μg/mL||Standard Deviation|Mean
86347|NCT00943670|Secondary|Number of Participants With Decreased Ejection Fraction|"Left ventricular ejection fraction (LVEF) was assessed on the basis of local assessments of echocardiogram or multigated acquisition scan (MUGA) data. A decrease in LVEF is defined as a decrease from Baseline of greater than or equal to 15%.~Grade 3 LVEF is an ejection fraction between 20 and 40%."|Assessed at Baseline and after every 3 cycles, up to 1 year.|Safety-Evaluable Patients (i.e., the treated population).||participants|||Number
86348|NCT00943670|Secondary|Number of Participants With Adverse Events (AEs)|"An serious AE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s), or is considered a significant medical event by the investigator (e.g., may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).~The severity of each AE was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0, or as follows: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Very severe; Grade 5 = Death related to AE."|From first dose until 30 days after last dose (up to 1 year).|Safety-Evaluable Patients (i.e., the treated population).||participants|||Number
86349|NCT00943670|Secondary|Percentage of Participants With Clinical Benefit During the Single-agent Trastuzumab Emtansine Treatment Period|"Participants were considered to have experienced clinical benefit if they had an objective response or maintained stable disease for at least 6 months from start of study treatment. Objective response was defined as a complete or partial response determined on two consecutive tumor assessments at least 4 weeks apart based on a modified version of RECIST.~Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started and no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
86350|NCT00943670|Secondary|Progression-free Survival During the Single-agent Trastuzumab Emtansine Treatment Period|Progression-free survival (PFS) was defined as the time from the first day of study treatment (Day 1) to first documented disease progression or death, whichever occurred first. If a patient did not experience disease progression or die, PFS was censored at the day of the last tumor assessment that a patient was known to be progression free.|From the first day of study treatment to the first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients.||months||95% Confidence Interval|Median
86351|NCT00943670|Secondary|Duration of Objective Response Based on Investigator Assessment During the Single-agent Trastuzumab Emtansine Treatment Period|"In patients with an objective response during the single-agent trastuzumab emtansine treatment period, duration of response was defined as the time from the first documented objective response to the time of first documented disease progression or death, whichever occurred first. Progressive disease was defined as either at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with an absolute increase of at least 5 mm, or the appearance of one or more new lesions, or the unequivocal progression of existing nontarget lesions.~If a patient did not die or experience disease progression before the end of the study, duration of response was censored at the day of the last tumor assessment when the patient was known to be progression free."|Time from the first documented objective response to the time of first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients who achieved an objective response.||months||95% Confidence Interval|Median
86352|NCT00943670|Secondary|Percentage of Participants With an Objective Response During the Single-agent Trastuzumab Emtansine Treatment Period|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments conducted by the investigator ≥ 4 weeks apart. Responses were assessed by physical examination and imaged-based evaluation using a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0:~CR—the disappearance of all target lesions and the disappearance of all nontarget lesions and normalization of tumor marker level and no new lesions.~PR—either the disappearance of all target lesions with persistence of one or more nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter with no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug. Patients with missing or no post-baseline response assessments were classified as non-responders.||percentage of participants||95% Confidence Interval|Number
86353|NCT00943670|Secondary|Percentage of Participants With New Abnormal T Waves|The incidence of abnormal T-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable. C=Cycle; D=Day.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
86354|NCT00943670|Secondary|Percentage of Participants With New Abnormal U Waves|The incidence of abnormal U-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
86355|NCT00943670|Secondary|Percentage of Participants Within Each Baseline-adjusted QTc Interval Category|"The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTc interval was subtracted from the average QTc intervals to create a baseline-adjusted average QTc interval.~QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14."|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
86356|NCT00943670|Secondary|Percentage of Participants Within Each Absolute QTc Interval Category|The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14.|Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.||percentage of participants|||Number
86357|NCT00943670|Secondary|Change From Baseline in Heart Rate||Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.||beats per minute||Standard Deviation|Mean
86358|NCT00943670|Secondary|Change From Baseline in QRS Duration|The QRS interval represents the time it takes for depolarization of the ventricles and was calculated from electrocardiogram (ECG) data. Each participant had triplicate QRS intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QRS interval was subtracted from the average QRS intervals to create a baseline-adjusted average QRS interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||milliseconds||Standard Deviation|Mean
86359|NCT00943670|Secondary|Change From Baseline in PR Interval|The PR interval is the time in seconds from the beginning of the P wave to the beginning of the QRS complex, and was calculated from electrocardiogram (ECG) data. Each participant had triplicate PR intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline PR interval was subtracted from the average PR intervals to create a baseline-adjusted average PR interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG-Evaluable population||milliseconds||Standard Deviation|Mean
86360|NCT00943670|Secondary|Change From Baseline in Uncorrected QT Interval|The uncorrected QT interval was calculated from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QT interval was subtracted from the average QT intervals to create a baseline-adjusted average QT interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||milliseconds||Standard Deviation|Mean
86361|NCT00943670|Secondary|Change From Baseline in Mean Duration of the QTc Interval Using Bazett’s Correction|The corrected QT interval was calculated using Bazett’s correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTcB intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcB interval was subtracted from the average QTcB intervals to create a baseline-adjusted average QTcB interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.||milliseconds||Standard Deviation|Mean
86362|NCT00943670|Primary|Change From Baseline in Mean Duration of the QTc Interval|The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia’s correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant’s corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population consisted of patients who received T-DM1, had at least 1 interpretable pre−T-DM1 ECG measurement recorded on Cycle 1 Day 1, had at least 1 interpretable post−T-DM1 ECG measurement and who were not treated with medications that may have altered cardiac conduction. N indicates the ECG−evaluable population at each time point.||milliseconds||Standard Deviation|Mean
86363|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.||Participants|||Number
86364|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.||Participants|||Number
86365|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.||Participants|||Number
86366|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86367|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86368|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 and Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86377|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
86772|NCT00939874|Secondary|Percentage of Participants With HIV Viral Load <50 Copies/mL|Plasma HIV viral load remained <50 copies/mL|from Baseline to Week 96|Week 96 data were available for 32 completed participants||percentage of participants|||Number
86369|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.||Participants|||Number
86370|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86371|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.||Participants|||Number
86372|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86373|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86374|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86375|NCT00943631|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
86376|NCT00943631|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
86391|NCT00943592|Secondary|Progression-free Survival (PFS)|Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.|1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
86378|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
86379|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
86380|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.||Participants|||Number
86381|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 8-10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 and 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86382|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
86383|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.||Participants|||Number
86384|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.||Participants|||Number
86385|NCT00943631|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|||Participants|||Number
86386|NCT00943605|Secondary|Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
86387|NCT00943605|Primary|Area of Skin Necrosis Measured With a Standard Ruler||1 and 6 weeks postoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
86388|NCT00943605|Primary|Total Serous Drainage (mL) From Time of Drain Placement to Removal.||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.|||||
86389|NCT00943592|Secondary|Relapse Rate||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
86390|NCT00943592|Secondary|Treatment-related Mortality (TRM)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days||percentage of participants||95% Confidence Interval|Number
86392|NCT00943592|Primary|Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30|||participants|||Number
86398|NCT00943579|Secondary|Aberrant Behavior Checklist (ABC)|This is a 58-item informant-based, factor-analyzed scale comprised of a total scale and 5 subscales that generate raw scores. Scores based on a likert scale ranging from 0-3 where 0 is not a problem to 3 where the problem is severe. Subscales include: Irritability, Social Withdrawal, Stereotypic Behaviors, Hyperactivity and Inappropriate Speech. Total maximum score is 174. Higher subscale scores indicate more symptoms. Scores are totaled to compute subscale scores. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|all participants who completed the open label extension were analyzed.||units on a scale||Standard Error|Mean
86399|NCT00943579|Secondary|Connor’s Preschool ADHD Questionnaire||Weeks 8 & 16||||||
86400|NCT00943579|Secondary|Preschool Language Scale, 4th Edition (PLS-4)|Measures expressive & receptive language and total scores in ages 0 to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher raw scores indicate better language skills. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept & trend modeling that accounts for each individual's initial level of symptom severity/functioning & rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants completed the open label extension were analyzed in the study.||units on a scale||Standard Error|Mean
86401|NCT00943579|Secondary|Parental Global Assessment||Weeks 8 & 16||||||
86402|NCT00943579|Secondary|Children’s Yale Brown Obsessive Compulsive Scale||Weeks 8 & 16||||||
86403|NCT00943579|Secondary|Vineland Adaptive Behavior Scale, 2nd Edition|The Vineland-2 is semi-structured interview designed to communication, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite Scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. The scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in this study. Higher subscale scores indicate more skills. Raw scores can range from 0 to 766 for the overall adaptive behavior composite. Subscales are combined to form the overall Adaptive Behavior Composite, which is essentially a weighted average of the various subscales combined.|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants who completed the open label extension were analyzed.||units on a scale||Standard Error|Mean
86404|NCT00943579|Primary|Clinical Global Impressions Scale|This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale (1) very much improved, (2) much improved, (3) minimally improved (4) no change, (5) minimally worse, (6) much worse and (7) very much worse. Chi-square analyses were used to assess change in CHI-I scores (by group, post-test)Mixed-effects regression models determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. The mixed-effects regression model is robust to data dependency that occurs with the repeated assessments of individuals over time & can handle missing data. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|16 weeks|The number of participants analyzed included those who completed the open label extension of this study.||# participants much - very much improved|||Number
86405|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and four due to receiving non-study vaccines prior to the visit.||Participants|||Number
86406|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.||Participants|||Number
86434|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Rest Session)|carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
86407|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.||Participants|||Number
86408|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86409|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and four due to receiving non-study vaccines prior to the visit.||Participants|||Number
86410|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.||Participants|||Number
86411|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two due to receiving non-study vaccines prior to the visit.||Participants|||Number
86412|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86413|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.||Participants|||Number
86799|NCT00939692|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|||ng/ml||Standard Deviation|Mean
86414|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86415|NCT00943488|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
86416|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two were excluded due to receiving non-study vaccines prior to the visit.||Participants|||Number
86417|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86418|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.||Participants|||Number
86419|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86420|NCT00943488|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
86421|NCT00943488|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
86422|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
86423|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
86424|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.||Participants|||Number
86425|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.||Participants|||Number
86426|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
86427|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
86428|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort||Participants|||Number
86429|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort||Participants|||Number
86430|NCT00943436|Primary|Percent Energy From Fat at the Meal (Rest Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
86431|NCT00943436|Primary|Percent Energy From Fat at the Meal (Exercise Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
86432|NCT00943436|Primary|Percent Energy From Protein at the Meal (Rest Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
86773|NCT00939874|Primary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips|Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96|from Baseline to Weeks 48 and 96|Week 48 data were available for 37 completed participants and Week 96 data were available for 32 completed participants. Fifteen of the enrolled 52 participants were screen failures.||percent change||95% Confidence Interval|Mean
86435|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Exercise Session)|Carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||percentage of kilocalorie intake||Standard Deviation|Mean
86436|NCT00943436|Primary|Energy Intake at the Meal (Rest Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||kilocalories||Standard Deviation|Mean
86437|NCT00943436|Primary|Energy Intake at the Meal (Exercise Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours|||kilocalories||Standard Deviation|Mean
86438|NCT00943397|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 52 weeks of treatment|All patients who took study medication were included in the analysis.||Participants|||Number
86439|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). Percent change was calculated as [(Month 24 – Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
86440|NCT00943384|Secondary|Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70).|Month 24|Per protocol||units on a scale||Standard Deviation|Mean
86441|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). Percent change was calculated as [(Month 24 – Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
86442|NCT00943384|Secondary|Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69).|Month 24|Per protocol||units on a scale||Standard Deviation|Mean
86443|NCT00943384|Secondary|Percent Change in Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
86444|NCT00943384|Secondary|Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Per protocol.||units on a scale||Standard Deviation|Mean
86518|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin|Plasma Area Under the Curve of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 208 and 210 subjects were available for simvastatin AUC(0-48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL * Hour||Standard Deviation|Least Squares Mean
86445|NCT00943384|Secondary|Percent Change in Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Back pain was assessed in the per-protocol population. Of the 55 subjects who were evaluated at the Month 24 visit, two were missing data related to back pain.||percent change||Standard Deviation|Mean
86446|NCT00943384|Secondary|Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Of the 55 subjects who were evaluated at Month 24, two were missing back pain data.||units on a scale||Standard Deviation|Mean
86447|NCT00943384|Secondary|Percent Change in Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. Percent change in ODI score was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol||percent change||Standard Deviation|Mean
86448|NCT00943384|Secondary|Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function.|Month 24|Per protocol||units on a scale||Standard Deviation|Mean
86449|NCT00943384|Primary|Posterolateral Fusion Success|The primary outcome for posterolateral fusion status was a composite endpoint incorporating posterior bridging bone status, intersegmental motion (angular and translational motion) and posterior hardware status. To have successful posterolateral fusion, a subject had to be successful in all four components at all levels under investigation. Failure to meet any one of the four components indicated failed posterolateral fusion status.|Month 24|The primary endpoint was evaluated for the per-protocol population. Of the 55 patients who were evaluated at the Month 24 visit, six patients were missing complete radiographic data needed to evaluate the primary endpoint.||participants|||Number
86450|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86451|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86452|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86453|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. This outcome restricts to age stratum.||Participants|||Number
86454|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86455|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86456|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86457|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86458|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86459|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86460|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86519|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin Acid|Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 201 and 202 subjects were available for simvastatin acid Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL||Standard Deviation|Least Squares Mean
86461|NCT00943202|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through 180 days after the last vaccination|All participants receiving at least one vaccination are included in the safety cohort. Analyses are as treated.||Participants|||Number
86462|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86463|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86464|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86465|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86466|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86467|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86468|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86520|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid|Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 200 and 202 subjects were available for simvastatin acid AUC(0 to 48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL * Hour||Standard Deviation|Least Squares Mean
86469|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86470|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86471|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86472|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86473|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86474|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86475|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86476|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86494|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86477|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86478|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86479|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86480|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86481|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86482|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86483|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 3 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86484|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86515|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Laropiprant||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively||nmol/L||Standard Deviation|Least Squares Mean
86485|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 2 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86486|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86487|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86488|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86489|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86490|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86491|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86492|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86493|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86495|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86496|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86497|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86498|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86499|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86500|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and 21 days after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86501|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.||Participants|||Number
86516|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant|Plasma Area Under the Curve of Laropiprant|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant AUC(0 to infinity) analysis for MK0524B and Simvastatin + MK0524A, respectively||nmol/L * hour||Standard Deviation|Least Squares Mean
86502|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86503|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86504|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.||Participants|||Number
86505|NCT00943150|Secondary|Diet Volume|Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||units on a scale||Standard Deviation|Mean
86506|NCT00943150|Secondary|Activity Level|Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||units on a scale||Standard Deviation|Mean
86507|NCT00943150|Secondary|Postoperative Pain Levels|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||units on a scale||Standard Deviation|Mean
86508|NCT00943150|Secondary|Narcotic Consumption|Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.|Intraoperative and postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||Fentanyl microgram units/g||Standard Deviation|Mean
86509|NCT00943150|Secondary|Change in Hemoglobin|The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.|Intraoperative|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||g/dL||Standard Deviation|Mean
86510|NCT00943150|Secondary|Total Drainage Output||0 to 10 days postoperatively|One subject was removed from the analysis of secondary variables owing to a protocol deviation.||mL||Standard Deviation|Mean
86511|NCT00943150|Primary|Inflammatory Cell Count|Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.|0, 3, and 6 weeks|||cells per square millimeter||Standard Deviation|Mean
86512|NCT00943150|Primary|Acute Thermal Injury Depth|"Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.~Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation."|Immediately postoperative|||micrometers||Standard Deviation|Mean
86513|NCT00943124|Primary|Total Urinary Excretion of Niacin and Its Metabolites||96 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 216 subjects were available for both MK0524B and Simvastatin + MK0524A for analysis of urinary excretion of nicotinuric acid and metabolites||µmol||Standard Deviation|Least Squares Mean
86514|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Nicotinuric Acid|Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin|24 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4) and missing samples (N=1), data from a total of 215 and 216 subjects available for plasma nicotinuric acid analysis for MK0524B and Simvastatin + MK0524A, respectively.||ng/mL||Standard Deviation|Least Squares Mean
86521|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 208|Percent change in liver volume = ([liver volume at Week 208 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 liver volume assessment.||percent change||Standard Deviation|Mean
86522|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (in MN) at Week 208|Percent change in spleen volume = ([spleen volume at Week 208 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 spleen volume assessment.||percent change||Standard Deviation|Mean
86523|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 208|Percent change in platelet counts = ([platelet count at Week 208 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 platelet assessment.||percent change||Standard Deviation|Mean
86524|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 208|Absolute change = hemoglobin level at Week 208 minus hemoglobin level at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 hemoglobin assessment.||g/dL||Standard Deviation|Mean
86525|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 208 minus Z-score at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 208 Z-score assessment for specified bone area.||Z-score||Standard Deviation|Mean
86526|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 208 minus T-score at baseline.|Baseline, Week 208|Number of participants analyzed = participants with both baseline and Week 208 T-score assessment.||T-Score||Standard Deviation|Mean
86527|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 52|Percent change in liver volume = ([liver volume at Week 52 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 liver volume assessment. Eliglustat participants switching to imiglucerase were excluded.||percent change||Standard Error|Least Squares Mean
86528|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (MN) at Week 52|Percent change in spleen volume = ([spleen volume at Week 52 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 spleen volume assessment. Eliglustat participants switching to imiglucerase were excluded.||percent change||Standard Error|Least Squares Mean
86529|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 52|Percent change in platelet counts = ([platelet count at Week 52 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 platelet assessment. Eliglustat participants switching to imiglucerase were excluded.||percent change||Standard Error|Least Squares Mean
86530|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 52|Absolute change = hemoglobin level at Week 52 minus hemoglobin level at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 hemoglobin assessment. Eliglustat participants switching to imiglucerase were excluded.||g/dL||Standard Error|Least Squares Mean
86531|NCT00943111|Secondary|Hemoglobin Level||Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline hemoglobin assessment.||gram per deciliter (g/dL)||Standard Deviation|Mean
86532|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 52 minus Z-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 52 Z-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.||Z-score||Standard Error|Least Squares Mean
86533|NCT00943111|Secondary|Total Z-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline Z-score assessment. Here, 'n' signifies participants with baseline Z-score assessment for specified bone area.||Z-score||Standard Deviation|Mean
86534|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant’s bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 52 minus T-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 T-score assessment. Here, 'n' signifies participants with both baseline and Week 52 T-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.||T-score||Standard Error|Least Squares Mean
86535|NCT00943111|Secondary|Total T-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by dual energy X-Ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-score compares participant’s bone density with that of healthy young participant. The T-score bone density categories are: normal (score greater than [>]-1), osteopenia (score -2.5 to less than or equal to [<=] -1), and osteoporosis (score <= -2.5).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline T-score assessment. Here, 'n' signifies participants with baseline T-score assessment for specified bone area.||T-score||Standard Deviation|Mean
86536|NCT00943111|Primary|Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in MN). Stable hematological parameters were defined as hemoglobin level did not decrease >1.5 g/dL from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume did not increase >20% from baseline.|Week 52 up to week 208|FAS population for LTTP: included all participants who received at least 1 dose of eliglustat in the extension study period. Number of participants analyzed=participants at risk at specified time-points. Here 'n' signifies number of participants with available data for specified time-points.||percentage of participants|||Number
86537|NCT00943111|Primary|Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in multiples of normal [MN]). Stable hematological parameters were defined as hemoglobin level did not decrease more than (>) 1.5 gram per deciliter (g/dL) from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume (in MN) did not increase >20% from baseline.|Baseline up to Week 52|Per protocol population for PAP included participants who were at least 80% compliant with treatment during PAP, had no major protocol deviations, and did not exhibit hematological decline as a result of medically determined etiologies other than Gaucher disease.||percentage of participants||95% Confidence Interval|Number
86538|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the ITT population: defined as all randomised patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose.||mm||95% Confidence Interval|Least Squares Mean
86539|NCT00943098|Secondary|PIDs||at 8 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86540|NCT00943098|Secondary|PIDs||at 7 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86541|NCT00943098|Secondary|PIDs||at 6 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86542|NCT00943098|Secondary|PIDs||at 5 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86543|NCT00943098|Secondary|PIDs||at 4 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86544|NCT00943098|Secondary|PIDs||at 3 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86545|NCT00943098|Secondary|PIDs||at 2 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86546|NCT00943098|Secondary|PIDs||at 90 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86547|NCT00943098|Secondary|PIDs||at 60 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86548|NCT00943098|Secondary|PIDs||at 45 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86549|NCT00943098|Secondary|PIDs||at 30 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86550|NCT00943098|Secondary|PIDs||at 15 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).||mm||Standard Deviation|Mean
86577|NCT00942786|Other Pre-specified|Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events|Evaluation of the association between preoperative NT-ProBNP and occurence of adverse cardiac events|postoperatively (index surgery) until a median follow-up of 34 months|||pg/ml||Inter-Quartile Range|Median
86551|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the PP population: all patients included in the ITT population who also met all inclusion/exclusion criteria and who did not have any major protocol violation, and with post-surgical pain assessment at the primary endpoint.||mm||95% Confidence Interval|Least Squares Mean
86552|NCT00943072|Secondary|Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)|The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 24|||scores on a scale||Standard Deviation|Mean
86553|NCT00943072|Secondary|Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks||Baseline to Week 24|Full Analysis Set||percentage of participants|||Number
86554|NCT00943072|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and at Week 24|Full Analysis Set||microns||Standard Deviation|Mean
86555|NCT00943072|Secondary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at Week 24|Full Analysis Set||letters correctly read||Standard Deviation|Mean
86556|NCT00943072|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score|"Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.~Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning."|Baseline and at Week 24|Full Analysis Set||percentage of participants|||Number
86557|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4|Secondary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.||mmHg||Standard Deviation|Mean
86558|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4|Primary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.||mmHg||Standard Deviation|Mean
86559|NCT00942994|Secondary|Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.|To compare the cumulative percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.||Percentage of Responders|||Number
86560|NCT00942994|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks|To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP <140 mmHg and MSDBP <90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.||Percentage of Participants|||Number
86561|NCT00942994|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.||mmHg||Standard Deviation|Mean
86562|NCT00942994|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.||mmHg||Standard Deviation|Mean
86563|NCT00941889|Primary|The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.|Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.|Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment|Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.||participants|||Number
86564|NCT00941863|Other Pre-specified|Other Adverse Events|Frequency Threshold for reporting Other Adverse Events: 5%. The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.||Participants|||Number
86565|NCT00941863|Other Pre-specified|Serious Adverse Events|The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.||Participants|||Number
86566|NCT00941863|Secondary|Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|At day 2 in study|subjects with valid PK profiles||hours||Full Range|Median
86567|NCT00941863|Secondary|Maximum Concentration (CMAX) Start From Day 2 of Cycle 1|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|At day 2 in study|subjects with valid PK profiles||mg/L||Standard Deviation|Geometric Mean
86568|NCT00941863|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|At day 2 in study|subjects with valid pharmacokinetics (PK) profiles||mg*h/L||Standard Deviation|Geometric Mean
86569|NCT00941863|Secondary|Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From start of treatment until progression or death occurs assessed every 6 weeks.|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population||Participants|||Number
86570|NCT00941863|Primary|Participants With Hematological and Biochemical Toxicities|Participants are considered at risk for toxicity if participants had a lab measurement for the toxicity >= National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 as defined by the NCI CTC version 2; SGOT: Serum Glutamic-Oxaloacetic Transaminase, SGPT: Serum Glutamic-Pyruvic Transaminase, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase.|Start of treatment until death or within 14 days last study drug intake|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population.||Participants|||Number
86571|NCT00941863|Primary|Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin|MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.|21 days|All subjects who received at least 1 dose of any study drug treatment were included in the Intent-To-Treat/safety populations. Efficacy parameters of time to death, time to progression, and response rate (confirmed partial response [PR] plus complete response [CR]) were determined for this population.||mg|||Number
86572|NCT00942903|Secondary|Noise at Stoma Occlusion|the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME|3 weeks|||patients|||Number
86573|NCT00942903|Primary|Patient Preference for Provox HME or Provox XtraHME|the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.|3 weeks|||Patients|||Number
86574|NCT00942851|Secondary|% Blepharospasm Disability Scale (BDS) Change at 3 Months|% BDS change at 3 months. The BDS is a quality of life scale ranging from 0 (no symptoms) to 26 (maximum impact of symptoms on quality of life). The questions are specific for impairment related to blepharospasm. We compared the percentage change over three months in the active and placebo arms.|baseline to 3 months|One placebo arm participant discontinued study due to unrelated personal problems||percentage change||Standard Deviation|Mean
86575|NCT00942851|Secondary|Change in the JBRS at 3 Months|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time.|baseline to 3 months|One placebo arm participant dropped out due to unrelated personal problems||points||Standard Deviation|Mean
86576|NCT00942851|Primary|Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time. Return to baseline value represents loss of benefit from BoNT injection. The time to return to baseline JBRS is an indication of added benefit from the topical intervention.|3-7 months|||month||Standard Deviation|Mean
86579|NCT00942786|Primary|Occurence of Adverse Cardiac Events|"Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death).~Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality.~Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure."|postoperatively (index surgery) until a median follow-up of 34 months|||participants|||Number
86580|NCT00942734|Primary|12-Week Progression-Free Survival (PFS)|Tumor assessments performed by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) after 4 weeks, 12 weeks, then every 8 weeks thereafter. Participants who received at least one dose of RAD001+erlotinib and who die before 12 weeks, counted as having progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progression-free survival defined as stable disease or better. Progressive Disease (PD): >20% increase in sum of LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started.|12 weeks|Eight participants were not evaluable.||Percentage of Participants|||Number
86581|NCT00942604|Secondary|Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions|Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area|57 days|Intention to treat population||participants|||Number
86582|NCT00942604|Primary|Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions|Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area|57 days|Intention to treat population||participants|||Number
86583|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||95% Confidence Interval|Least Squares Mean
86584|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 8 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86585|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 7 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86586|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 6 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86587|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 5 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86588|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 4 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86589|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 3 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86590|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 2 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86607|NCT00942175|Primary|Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.|Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PD statistical analyses for those parameters.||percentage of MPA||Standard Deviation|Mean
86591|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 90 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86592|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 60 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86593|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 45 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86594|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 30 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86595|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 15 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||Standard Deviation|Mean
86596|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);||mm||95% Confidence Interval|Least Squares Mean
86597|NCT00942422|Primary|Sustained M-protein Reduction of ≥ 25% From Baseline|"This is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a minor response, an improvement recognized as having some clinical benefit."|Day one of each 28-day cycle for a total of up to 6 cycles|||percentage of patients|||Number
86598|NCT00942409|Primary|Overall Response Rate||2 Years|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure|||||
86599|NCT00942266|Secondary|Fluorouracil Steady-state Pharmacokinetics|Blood samples will be collected for determination of plasma 5-FU steady state concentration at 6 hours after start of 5-FU continuous infusion. The mean per treatment arm are presented.|Day 1|All treated and eligible patients||ng/ml||95% Confidence Interval|Mean
86600|NCT00942266|Secondary|Vorinostat Pharmacokinetics|Blood samples (5 ml of blood each) will be collected in red-top vacutainers (no anticoagulant) at 0 (pre- vorinostat), 0.5, 1, 2, 3, 4, 6, and 8 hours after the vorinostat dose on the first day of 5-FU infusion on cycle 1 (day 2 of cycle 1). Mean area under the curve is presented with 95% CI.|day 2 (cycle 1)|Vorinostat PKs were be performed on day 2 of vorinostat in the first 10 patients of each arm treated at RPCI||hr∙μM||95% Confidence Interval|Mean
86601|NCT00942266|Secondary|Overall Survival||Every 12 weeks|All treated and eligible patients; per protocol||months||95% Confidence Interval|Median
86602|NCT00942266|Secondary|Toxicity|"Number of participants with an adverse event.~Please refer to the adverse event reporting for more detail."|Daily|All treated and eligible patients; per protocol||participants|||Number
86603|NCT00942266|Secondary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Every 8 weeks; up to 100 weeks.|All treated and eligible patients; per protocol||percentage of participants||95% Confidence Interval|Number
86604|NCT00942266|Secondary|Median Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks, up to 100 weeks.|All treated and eligible patients; per protocol||months||95% Confidence Interval|Median
86605|NCT00942266|Primary|Disease Control Rate (Stable Disease or Objective Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|At 2 months|All treated and eligible patients; per protocol||percentage of participants||95% Confidence Interval|Number
86606|NCT00942175|Primary|Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.|MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK and PD statistical analyses for those parameters.||percentage of MPA||Standard Deviation|Mean
88720|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mmHg||Standard Deviation|Mean
86608|NCT00942175|Primary|Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).|PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacodynamics (PD) statistical analyses for this parameter.||percent inhibition||Standard Deviation|Mean
86609|NCT00942175|Primary|Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel’s Active Metabolite.|Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 9 of each period|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK statistical analyses for those parameters.||ng*hr/ML||Standard Deviation|Mean
86610|NCT00942175|Primary|Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel’s Active Metabolite.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 9 of each period|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacokinetics (PK) statistical analyses for this parameter.||ng/mL||Standard Deviation|Mean
86611|NCT00942149|Secondary|Adverse Events Will be Monitored.||7 days following last dose of study drug||||||
86612|NCT00942149|Primary|PK of Daptomycin|Area under the curve|24 hours|all 20 subjects were analyzed||mg*h/L||Full Range|Median
86613|NCT00942084|Primary|Minimum Steady State Concentration (Cminss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||mg/L||Full Range|Median
86614|NCT00942084|Primary|Steady State Concentration at 50% of the Dosing Interval (C50ss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||mg/L||Full Range|Median
86615|NCT00942084|Primary|Maximum Steady State Concentration (Cmaxss)||up to 3 dasy of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||mg/L||Full Range|Median
86616|NCT00942084|Primary|Half-life (T1/2)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||h||Full Range|Median
86617|NCT00942084|Primary|Volume of Distribution (V)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||L/kg||Full Range|Median
86618|NCT00942084|Primary|Clearance (CL)|"Timeframe:~Version 1:0-5 min,2-4 hrs,6-8 hrs post doses 1 and 5-15; prior to doses 5-15 Version 2:0-15 min post doses 1 and 5-15; within 30 min prior to doses 2 and 5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose"|V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.||L/h/kg||Full Range|Median
86619|NCT00941993|Primary|Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).||Day 0|||participants|||Number
86620|NCT00941993|Other Pre-specified|Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.|"The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.~Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears."|Day 0|Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted||units on a scale||Standard Deviation|Mean
86621|NCT00941993|Secondary|Subject/Parent Reported Satisfaction With the In-office Procedure|"Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: ‘Overall, I am satisfied with the whole procedure’. Response options included: ‘Strongly Disagree’, ‘Disagree’, ‘Neutral’, ‘Agree’ or ‘Strongly Agree’. The number of respondents who reported that they ‘agree’ or ‘strongly agree’ that they were satisfied with the whole procedure are reported.~The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period."|Day 0|||% adult subjects or parents||95% Confidence Interval|Number
86622|NCT00941993|Secondary|Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale|"Includes all subjects for whom Iontophoresis current delivery was initiated.~The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.~The Wong-Baker scores are reported by subject."|Day 0|Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available.||units on a scale||Standard Deviation|Mean
86623|NCT00941993|Primary|Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment|Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.|Day 0|||percentage of subjects||95% Confidence Interval|Number
86624|NCT00941928|Secondary|Overall Survival (OS)|Number of surviving participants without disease progression or death for any reason at one year post treatment.|Minimum of 1 year, or until disease progression or death||||||
86625|NCT00941928|Primary|Time to Progression (TTP)|TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year|1 Year|Both participants had recurrent disease before single month assessment therefore no data was analyzed. Study was terminated early due to slow accrual.|||||
86626|NCT00941798|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit|"The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control.~Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||units on a scale||Standard Error|Least Squares Mean
86627|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime|24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||percentage of days||Standard Error|Least Squares Mean
86628|NCT00941798|Secondary|Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime|"Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment.~Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and endpoint were included in this analysis.||units on a scale||Standard Error|Least Squares Mean
86629|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime|Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||percentage of days||Standard Error|Least Squares Mean
86630|NCT00941798|Secondary|Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period|"PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits.~Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and at final visit were included in this analysis.||liters per second||Standard Error|Least Squares Mean
86631|NCT00941798|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||liter||Standard Error|Least Squares Mean
86632|NCT00941798|Secondary|Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||liters||Standard Error|Least Squares Mean
86633|NCT00941798|Secondary|Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.||liters||Standard Error|Least Squares Mean
86647|NCT00941733|Secondary|Primary Sustained Clinical Improvement|Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects||percentage of participants analyzed|||Number
86634|NCT00941798|Secondary|Number of Patients With at Least One Asthma Worsening Post-baseline|The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) >= 20% from mean baseline on >= 3 consecutive days, nighttime symptom score >= 2 on >= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) >=20% from baseline at evening visits, daytime symptom score of 3 or 4 on >= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use >= 8 puffs on >= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||participants|||Number
86635|NCT00941798|Secondary|Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids|Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||participants|||Number
86636|NCT00941798|Secondary|Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.|The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||participants|||Number
86637|NCT00941798|Primary|Time to First Serious Asthma Exacerbation|Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.||months||Full Range|Median
86638|NCT00941733|Secondary|Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)|Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)|12 months|Angiographic subgroup only. Angio-target lesion is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis higher than 70% and a cumulative length less than 100 mm that can be covered by a single IN.PACT Amphirion™; and Angio-target lesion is the only lesion in that vessel.||percentage of participants analyzed|||Number
86639|NCT00941733|Secondary|Days of Hospitalization|Days of hospitalization at 1 year|12 months|All randomized subjects with available data||days||Standard Deviation|Mean
86640|NCT00941733|Secondary|Procedural Success|Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications|Day 1|All randomized subjects with available data||percentage of participants analyzed|||Number
86641|NCT00941733|Secondary|Technical Success|Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography|Day 1|Number of device deployments||percentage of device deployments|||Number
86642|NCT00941733|Secondary|Device Success|Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities|Day 1|Number of device deployments||percentage of device deployments|||Number
86643|NCT00941733|Secondary|MAE (Major Adverse Events)|Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
86644|NCT00941733|Secondary|Walking Capacity Assessment|"Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.~A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) – 100 (maximum)."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for Walking Impairment assessment at baseline and 1 year||units on a scale||Standard Deviation|Mean
86645|NCT00941733|Secondary|Quality of Life Assessment by EQ5D|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.~EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for EQ5D at baseline and 1 year||units on a scale||Standard Deviation|Mean
86646|NCT00941733|Secondary|Secondary Sustained Clinical Improvement|Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects||percentage of participants analyzed|||Number
86665|NCT00941681|Primary|C Max (Day 1, Dose 1)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).||ng/mL||Standard Deviation|Mean
86648|NCT00941733|Secondary|Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)|Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
86649|NCT00941733|Secondary|Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)|Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (205 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
86650|NCT00941733|Secondary|Amputation Free Survival and Wound Healing|Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.|12 months|Percentage based on number of evaluable subjects for safety events (206 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
86651|NCT00941733|Secondary|Rate of Wound Healing|Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.|12 months|Patients with pre-existing wounds and/or occurence of new wounds||percentage of patients analyzed|||Number
86652|NCT00941733|Secondary|Amputation Free Survival|Percentage of participants with a 1 year amputation free survival.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
86653|NCT00941733|Primary|Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)|Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)|6 months|Percentage based on number of evaluable subjects for safety events (232 participants in the drug eluting balloon arm and 114 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.||percentage of participants analyzed|||Number
86654|NCT00941733|Primary|Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients|Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).|12 months|Amputation free surviving meaning participants without an amputation at 12 months. This analysis population consists of 196 participants in the Drug Eluting Balloon arm and 107 participants in the Standard PTA arm.||percentage of participants analyzed|||Number
86655|NCT00941733|Primary|Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)|The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up|12 months or at Target Lesion Revascularization (TLR) time|ITT||mm||Standard Deviation|Mean
86656|NCT00941720|Secondary|Pulmonary Toxicity|Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.|At 6 months|||percentage of participants||95% Confidence Interval|Number
86657|NCT00941720|Primary|Overall Survival|Number of patients alive at the end of the study period|at 6 months|||participants|||Number
86658|NCT00941720|Primary|Relapse-free Survival|Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .|at 6 months|||participants|||Number
86659|NCT00941681|Primary|AUC (Day 10)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).||hr*ng/mL||Standard Deviation|Mean
86660|NCT00941681|Primary|T Max (Day 10)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).||hr||Standard Deviation|Mean
86661|NCT00941681|Primary|C Max (Day 10)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).||ng/mL||Standard Deviation|Mean
86662|NCT00941681|Primary|AUC (Day 1, Dose 1)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).||hr*ng/mL||Standard Deviation|Mean
86663|NCT00941681|Primary|T Max (Day 1, Dose 1)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).||hr||Standard Deviation|Mean
86664|NCT00941681|Secondary|Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure.||1 week||||||
86668|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II|Time between the first day of treatment and the date of death|12 weeks up to 3 years|Patient #3 - alive 17 months at time of study closure; patient 5 alive 6 months at time of study closure; patient 13 alive 8 months at time of study closure; patients 10,12 randomized but withdrew/no treatment; patient 14 randomized but did not return for treatment and lost to follow up. Patient #16 was lost to follow up after being randomized.||Months|||Number
86669|NCT00941655|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|40.5 months|||Participants|||Number
86670|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I|Time between the first day of treatment and the date of death.|12 weeks up to 3 years|Patient #7 - alive 14 months at time of study closure; patient 11 alive 12 months at time of study closure; patient 15 expired following surgery.||Months|||Number
86671|NCT00941603|Secondary|Change From Baseline in Direct Non-HDL-C at Week 8|The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.||Percent change||Standard Error|Least Squares Mean
86672|NCT00941603|Primary|Change From Baseline in Direct LDL-C at Week 8|The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.||Percent change||Standard Error|Least Squares Mean
86673|NCT00941304|Secondary|Change From Baseline in Cognitive Assessment Using CNS-VS|"Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that lower score is better”, otherwise higher scores are better."|Baseline (screening), 2 hours 15 minutes postdose|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||Score||Standard Deviation|Mean
86674|NCT00941304|Secondary|Percentage of Participants With “Excellent” Investigator Global Rating of Study Drug|Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to “Overall, how would you rate the study medication for this subject?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||percentage of participants|||Number
86675|NCT00941304|Secondary|Percentage of Participants Reporting a Global Rating of Study Drug as “Excellent”|Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to “Overall, how would you rate the study medication you received for pain?”|8 hours and 24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||percentage of participants|||Number
86676|NCT00941304|Secondary|Duration of Analgesia|Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration.|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||hours||95% Confidence Interval|Median
86677|NCT00941304|Secondary|Onset of Analgesia|Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration.|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||hours||95% Confidence Interval|Median
86678|NCT00941304|Secondary|Peak Pain Relief|Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
86679|NCT00941304|Secondary|Peak Pain Intensity Difference|The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
86680|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 2 Hours|Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?” PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|2 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
86681|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 8 Hours|Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?” PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
86774|NCT00939809|Secondary|Biomarkers of Drug Effect on Peripheral Blood Mononuclear Cells (PBMCs)|Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.|Day 1 prior to dosing; Day 2 prior to dosing and 4-hour post dosing; Day 8 prior to dosing.||||||
86682|NCT00941304|Secondary|Total Pain Relief Over 8 Hours|Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?”|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
86683|NCT00941304|Primary|Sum of Pain Intensity Difference From Baseline to 8 Hours|Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|Baseline, 8 hours|Analysis based on intent-to-treat (ITT) population; all subjects who received study drug and provided at least 1 post-dose assessment.||units on a scale||Standard Deviation|Mean
86684|NCT00941070|Post-Hoc|Progression Free Survival by Smoking Status|Percent of patients that were progression free by smoking status|at 18 months from study entry|||percentage of paticipants||95% Confidence Interval|Number
86685|NCT00941070|Secondary|Progression Free Survival by HPV Subtype|Tabular descriptive data will be presented. HPV sub-type will be associated with treatment related toxicity, clinical response, PET metabolic response, and overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation will be used. Tests of equivalence of the estimates will be compared using the Wilcoxon long-rank test using a threshold for statistical significance of P 0.05. Cox proportional hazards regression models will be used in multivariate analyses.|Baseline|||percentage of patients||95% Confidence Interval|Number
86686|NCT00941070|Secondary|Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling||18 months from study entry|||participants|||Number
86687|NCT00941070|Secondary|Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire||Baseline to up to 5 years||||||
86688|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Up to 5 years||||||
86689|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|3 months post-treatment|Patients that completed 3-month 18F-FDG PET/CT||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
86690|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Baseline (pre-therapy)|Patients that completed the 3-month 18F-FDG PET/CT||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
86691|NCT00941070|Secondary|Progression-free Survival|Percentage of patients that did not have disease progression. Estimates of progression-free survival will be computed using the product-limit estimate of Kaplan and Meier.|at 18 months from study entry|Patients that completed the the 3-month 18F-FDG PET/CT.||percentage of patients||95% Confidence Interval|Number
86692|NCT00941070|Secondary|Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011|Information will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Frequency tables will be constructed to summarize observed incidence by severity and type of toxicity.|After 5 weeks of radiation therapy|All patients who receive at least one dose of Triapine® and cisplatin treatment.||percentage of patients|||Number
86693|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|three month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.||participants|||Number
86694|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|one month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.||participants|||Number
86695|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|post therapy at 3 months|Patients that completed the 3-month F-18 FDG study.||participants|||Number
86723|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48|Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA < 1000 copies/mL was reported.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
86696|NCT00941070|Primary|Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.|To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.|post therapy at 3 months|1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study.||Standard uptake value (SUV)||Inter-Quartile Range|Median
86697|NCT00941031|Secondary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo|The investigator’s global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).|13 weeks|Full analysis set||Participants achieving goal|||Number
86698|NCT00941031|Secondary|The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29||week 21 to 29|(Full analysis set, LOCF)||Participants achieving goal|||Number
86699|NCT00941031|Primary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.|Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment|13 weeks|(Full analysis set, LOCF) Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment||Participants achieving goal|||Number
86700|NCT00940992|Primary|Change in Inflammatory Lesion Counts From Baseline|The LS mean changes from Baseline in inflammatory lesion count at Week 12.|Baseline to Week 12 / end of treatment|||Inflammatory lesions||95% Confidence Interval|Least Squares Mean
86701|NCT00940992|Primary|Investigator Global Assessment (IGA) Improvement From Baseline|The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).|Baseline to Week 12 / end of treatment|||percentage of subjects|||Number
86702|NCT00940927|Primary|Effect Maximum (Emax)|Maximum percentage of predicted FEV1 effect|15 minutes after each dose|||percentage of predicted|||Number
86703|NCT00940927|Primary|Effective Dose 50% (ED50)|ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol|15 minutes after each dose|||ug|||Number
86704|NCT00940875|Secondary|Duration of Response|Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|Data could not be summarized to be included in the data table because there are too few events to calculate a median and confidence intervals.|||||
86705|NCT00940875|Secondary|Overall Survival (OS)|OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS||weeks||95% Confidence Interval|Median
86706|NCT00940875|Secondary|Percentage of Participants Who Died||BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS||percentage of participants|||Number
86707|NCT00940875|Secondary|Percentage of Participants With Non-Progression at Weeks 8 and 16|Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.|Weeks 8 and 16|FAS||percentage of participants||95% Confidence Interval|Number
86708|NCT00940875|Primary|PFS|The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)|FAS||weeks||95% Confidence Interval|Median
86709|NCT00940875|Secondary|Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.|BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS||percentage of participants||95% Confidence Interval|Number
86775|NCT00939809|Secondary|Overall Survival||Every other cycle, up to 5 years|Eligible and treated participants||months||95% Confidence Interval|Median
86710|NCT00940875|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS||percentage of participants|||Number
86711|NCT00940576|Primary|Score of Crohn´s Disease and/or Ulcerative Colitis|score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), < 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.|8 weeks|||units on a scale||Standard Deviation|Mean
86712|NCT00940576|Secondary|Extra-intestinal Pain|The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).|8 weeks|||Percentage of days with pain||Standard Deviation|Mean
86713|NCT00940537|Secondary|T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water|T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences|baseline cross-sectional measurements|This analysis was per protocol.||ratio||Standard Deviation|Mean
86714|NCT00940537|Secondary|The Hepatic Triglyceride Content Pre- and Post-prandial.|We compared the intrahepatic triglyceride content in subjects after a 12 hour fast and 2 hours after eating a high fat, high carbohydrate meal. The measure reported here is for the pre and post prandial results given as the ratio of triglyceride signal to water signal. After showing its reliability, we chose to use the results from the optimized breath-hold sequence.|after a 12 hour fast and 2 hours post-prandial|||ratio||Standard Error|Mean
86715|NCT00940537|Primary|The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS.|We compared three 1H-Magnetic Resonance Spectroscopy sequences: A Standard Siemens sequence, and an optimized sequence with either breath-holds or free-breathing. Repeat scans were done with the subject briefly removed from and returned to the scanner between scans. The results given are coefficients of variation of the triglyceride signal divided by the water signal.|6 months|||coefficient of variation||Standard Error|Mean
86716|NCT00940485|Secondary|Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event|Participants with clinically significant laboratory abnormalities which were captured as an AE (at the >=5% threshold) were presented.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.||Participants|||Number
86717|NCT00940485|Secondary|Number of Participants With Incidence of Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.||Participants|||Number
86718|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time|Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBsAg calculated using ‘International Units Per Millilitre’ (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.||IU/ml||Standard Deviation|Mean
86719|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time|Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using ‘Paul Ehrlich Institute units per millilitre’ (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.||PEIU/ml)||Standard Deviation|Mean
86720|NCT00940485|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase at Week 48|Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value > upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
86721|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48|Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
86722|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
86725|NCT00940485|Primary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48|Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
86726|NCT00940290|Primary|Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication|"A fictitious clinical case of a child with acute diarrhea was presented. The physician read the case and then answered the question would you recommend racecadotril to this patient? A zero to 10 visual-analog scale and a Likert scale were used to measure the decision of the physician related to the clinical case presented (from zero=definitely no to 10=definitely yes). Mean differences before-after and among groups were measured on the 10 centimeters scale."|One day|||Mean change in centimeters||95% Confidence Interval|Mean
86727|NCT00940108|Secondary|Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination|Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.|During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86728|NCT00940108|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86729|NCT00940108|Secondary|Duration of Solicited AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
86730|NCT00940108|Secondary|Duration of Solicited AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
86731|NCT00940108|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.|During the 7 days after each vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86732|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86733|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86734|NCT00940108|Primary|GMFI in the HI Antibody Titre After the Second Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
86735|NCT00940108|Primary|Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
86736|NCT00940108|Primary|HI Antibody Titre Seroconversion Rate After the Second Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86737|NCT00940108|Primary|Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86738|NCT00940017|Primary|Concentration Ratio in ELF to Plasma|Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Subjects randomized to a single BAL procedure timepoint; bronchoscopy and BAL done for 5 different subjects at each timepoint.||ratio||Standard Deviation|Mean
86739|NCT00940017|Primary|Overall Drug Penetration Ratio in ELF|ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average ELF to plasma ratio|||Number
86740|NCT00940017|Primary|AM: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in AM did not allow calculation of t1/2; not analyzed.||hours|||Number
86741|NCT00940017|Primary|AM: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug*hr/mL)|||Number
86742|NCT00940017|Primary|AM: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||hours|||Number
86743|NCT00940017|Primary|Alveolar Macrophages (AM): Cmax|Cmax = maximum observed plasma concentration; observed directly from the data. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug/mL)|||Number
86744|NCT00940017|Primary|ELF PK: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in ELF did not allow calculation of t1/2; not analyzed.||hours|||Number
86745|NCT00940017|Primary|ELF PK: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug*hr/mL)|||Number
86746|NCT00940017|Primary|ELF PK: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||hours|||Number
86747|NCT00940017|Primary|Epithelial Lining Fluid (ELF) PK: Cmax|Cmax=maximum observed plasma concentration. ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL]. Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected. Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.||average concentration (ug/mL)|||Number
86748|NCT00940017|Primary|Plasma PK: Volume of Distribution at Steady-state (Vss)|Vss = volume of distribution at steady-state; measured as liters (L). Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]). MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean.||L||Standard Deviation|Mean
86749|NCT00940017|Primary|Plasma PK: Total Clearance (CL Total)|CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population||mL/min||Standard Deviation|Mean
88721|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mmHg||Standard Deviation|Mean
86750|NCT00940017|Primary|Plasma PK: Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean||hours||Standard Deviation|Mean
86751|NCT00940017|Primary|Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest.||ug*hr/mL||Standard Deviation|Mean
86752|NCT00940017|Primary|Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population||hours||Full Range|Median
86753|NCT00940017|Primary|Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL). Observed directly from the data. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population||ug/mL||Standard Deviation|Mean
86754|NCT00939991|Secondary|Phase II: Number of Patients With Grade 2 or Greater, Treatment-related Toxicities|Phase II: Number of patients with grade 2 or greater, treatment-related toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years|||participants|||Number
86755|NCT00939991|Secondary|Phase II: Median Overall Survival (OS)|Phase II: Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|3 years|||months||95% Confidence Interval|Median
86756|NCT00939991|Secondary|Phase II: Median Progression-free Survival (PFS)|Phase II: Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|3 years|||months||95% Confidence Interval|Median
86757|NCT00939991|Secondary|Phase II: Radiographic Response.|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria. A confirmation of response was not required. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments were done at baseline, the end of the first cycle (4 weeks), then the end of every second cycle (every 8 weeks) thereafter.|3 years|||percentage of participants||95% Confidence Interval|Number
86758|NCT00939991|Primary|Phase II: 6-month Progression-free Survival (PFS)|Phase II: Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months|||percentage of participants||95% Confidence Interval|Number
86759|NCT00939991|Primary|Phase I: Determination of the Maximum Tolerated Dose (MTD)|The MTD is based upon dose-limiting toxicities (DLTs) experienced during Cycle 1 of treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with at least two patients experiencing DLT at the next higher dose level. Using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, DLTs are defined as: Grade 4 neutropenia lasting greater than 5 days; Grade 3 thrombocytopenia; the occurrence of non-hematologic Grade 3 or greater drug-related adverse events excluding Grade ≥ 3 elevation in alkaline phosphatase, Grade ≥ 3 nausea or vomiting unless occurring despite the use of standard anti-emetics or Grade 3 diarrhea unless occurring despite standard anti-diarrheal therapy; > 14 day delay to re-treat due to failure to resolve drug-related toxicity to re-treatment criteria or pre-treatment baseline.|Cycle 1 (28 days)|||mg|||Number
86760|NCT00939952|Primary|Residual Drug in Peritoneal Cavity After 1st Exchange||6h|||mg||Standard Deviation|Mean
86761|NCT00939952|Primary|k31|1st order intercompartmental rate constant peritoneal cavity to central|12h|||h^(-1)||Standard Deviation|Mean
86762|NCT00939952|Primary|k13|1st order intercompartmental rate constant from central to peritoneal cavity|12h|||h^(-1)||Standard Deviation|Mean
86763|NCT00939952|Primary|k21|1st order intercompartmental rate constant from peripheral to central compartment|12h|||h^(-1)||Standard Deviation|Mean
86764|NCT00939952|Primary|k12|1st order intercompartmental rate constant between central and peripheral compartments|12h|||h^(-1)||Standard Deviation|Mean
86765|NCT00939952|Primary|Clearance (CL)|population PK clearance|12h|||Liters/hour (L/h)||Standard Deviation|Mean
86766|NCT00939952|Primary|Volume of Distribution, Central Compartment (Vc)|Population PK|12h|||Liters (L)||Standard Deviation|Mean
86767|NCT00939900|Secondary|Time to Total Arthroplasty or Joint Preserving Surgery||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
86768|NCT00939900|Secondary|Time to Collapse of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
86769|NCT00939900|Secondary|Change of HHS (Harris Hip Scores), WOMAC Score, SF-36||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
86770|NCT00939900|Secondary|Collpase Rate of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)||||||
86771|NCT00939900|Primary|Number of Participants With Femoral Head Collapse Within 24 Months||Measurements were done at 6, 12, 24 months|||participants|||Number
86776|NCT00939809|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
86777|NCT00939809|Primary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||Every cycle during treatment||||||
86778|NCT00939809|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||percentage of participants||90% Confidence Interval|Number
86779|NCT00939809|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months.|Eligible and treated participants||percentage of participants||90% Confidence Interval|Number
86780|NCT00939796|Secondary|Tube Retention|Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).|two weeks post-procedure|||retained tubes|Participants||Number
86781|NCT00939796|Secondary|Cross-Over to Manual Myringotomy and Tube Placement|Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.|at procedure visit|||number of ears|Participants||Number
86782|NCT00939796|Primary|Device Success|Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).|At procedure visit|All TTDS devices attempted||devices|Participants||Number
86783|NCT00939783|Secondary|Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >450 to <=480, >480 to <=500 and >500 msec, increase of >30 to <=60 and >60 msec for QT interval corrected using Fridericia's formula (QTcF).|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.||Percentage of participants|||Number
86784|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if observed value was more than or less than X times upper limit of normal (ULN) or lower limit of normal (LLN); X=specified in categories of each parameter in measured values section. For urinalysis abnormality was reported if result was >=1 in qualitative test of all parameters except red and white blood cells which were reported if result was >=6, indicating levels in urine were abnormal. Urine pH abnormality reported if >8 and urine specific gravity abnormality if <1.003 or >1.030.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular laboratory parameter.||Percentage of participants|||Number
86785|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Vital Signs|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline for systolic BP; absolute diastolic BP <50 mmHg with maximum increase or decrease of >=20 mmHg from baseline and absolute heart rate values <40 beats per minute (bpm), >120 bpm for supine or sitting measurement, >140 bpm for standing measurement.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.||Percentage of participants|||Number
86814|NCT00939510|Primary|Number of Patients With a PSA Response|Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.|reevaluated for response every eight weeks|All patients that received treatment.||participants|||Number
86786|NCT00939783|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses.||Percentage of participants|||Number
86787|NCT00939731|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L||Standard Deviation|Geometric Mean
86788|NCT00939731|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
86789|NCT00939731|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
86790|NCT00939731|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
86791|NCT00939731|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Standard Deviation|Mean
86792|NCT00939731|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||hr||Full Range|Median
86793|NCT00939731|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hours (hrs) post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
86794|NCT00939705|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.||ng h / ml|Participants|Standard Deviation|Mean
86795|NCT00939705|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.||ng h / ml|Participants|Standard Deviation|Mean
86796|NCT00939705|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.||ng / ml|Participants|Standard Deviation|Mean
86797|NCT00939692|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|||ng·h/mL||Standard Deviation|Mean
86798|NCT00939692|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|||mcg*hr/mL||Standard Deviation|Mean
86860|NCT00939211|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h|||bpm||Standard Deviation|Mean
86800|NCT00939627|Secondary|Overall Survival Associated With Immunomodulatory Cytokines|Twelve immunomodulatory cytokines were selected based on previous a feasibility study. One cytokines, HGF, was eliminated due to extremely low expression. Three cytokines, TGF-beta 1, IL-8 and VEGF were evaluated for association with survival.|Pre-therapy||||||
86801|NCT00939627|Other Pre-specified|Quality of Life||up to 3 years|The Quality of Life survey instrument was not completed by study participants, thus data is not available for analysis.|||||
86802|NCT00939627|Secondary|Gene Expression Levels|Gene Expression Levels were to be addressed using mostly descriptive statistics.|Pre-therapy and every 21 days for up to 9 weeks||||||
86803|NCT00939627|Secondary|Number of Participants With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.||participants|||Number
86804|NCT00939627|Secondary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On-study date to date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||months||95% Confidence Interval|Median
86805|NCT00939627|Secondary|Best Response|"Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD.~Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On-treatment date to date of disease progression (assessed up to 3 years)|All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.||participants|||Number
86806|NCT00939627|Primary|Progression Free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off-study date or last known alive date.||months||95% Confidence Interval|Median
86807|NCT00939562|Primary|Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline|AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|PK||ug*hr/mL||Standard Deviation|Mean
86808|NCT00939562|Primary|Maximum Plasma Concentration (Cmax) of Doxycycline||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|The pharmacokinetic (PK) concentration population was defined as all subjects randomized and treated who had at least 1 concentration in at least 1 treatment period.||ug/mL||Standard Deviation|Mean
86809|NCT00939536|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||mcg*hr/mL||Standard Deviation|Mean
86810|NCT00939536|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||mcg*hr/mL||Standard Deviation|Mean
86811|NCT00939536|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng/ml||Standard Deviation|Mean
86812|NCT00939510|Primary|RECIST-defined Measurable Disease|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks|every 8 weeks and at end of treatment|12 patients had RECIST-defined measurable disease. One patient came off study early for toxicity and therefore was not evaluable.||participants|||Number
86813|NCT00939510|Secondary|Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study|The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.|every 28 days for first 3 cycles, end of study|All patients that received treatment||participants|||Number
86861|NCT00939211|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h|||bpm||Standard Deviation|Mean
86815|NCT00939484|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data||ratio||Full Range|Median
86816|NCT00939484|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patients with sustained objective response||months||Full Range|Median
86817|NCT00939484|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years|||months||95% Confidence Interval|Median
86818|NCT00939484|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months|||proportion of participants||95% Confidence Interval|Number
86819|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SNOT-20)|Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).||change in SNOT-20 score||Standard Deviation|Mean
86820|NCT00939471|Secondary|Revision Rate|The number of subjects requiring revisions out of 33 subjects treated.|at 1 year|||participants|||Number
86821|NCT00939471|Secondary|Days Out of School During the 12 Months of Follow-up|Quantitative assessment of days out of school during the 12 months of follow-up.|12 months|||days||Standard Deviation|Mean
86822|NCT00939471|Secondary|Effectiveness of Dilation/Measured by Post-op Interventions|Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.|12 months|||number of interventions|||Number
86823|NCT00939471|Secondary|Effectiveness: Medication Thru 1 yr|Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.|12 months|||percentage of participants|||Number
86824|NCT00939471|Secondary|Device Success: Ability to Access/Dilate Sinus Ostia|Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.|12 months|intent to treat analysis||percentage of sinuses successful|Participants||Number
86825|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SN-5)|Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).||change in SN-5 score||Standard Deviation|Mean
86826|NCT00939471|Primary|Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months|Number of device-related adverse events from time of procedure through 12 months post-procedure.|12 months|||number of events|||Number
86827|NCT00939393|Primary|Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|24 weeks|Eleven (11) In-Office subjects and 10 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
86828|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|52 weeks|Sixteen (16) In-Office subjects and 24 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
86829|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|4 weeks|Six (6) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
86862|NCT00939211|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h|||mmHg||Standard Deviation|Mean
86830|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 week|Five (5) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.||scores on a scale||Standard Deviation|Mean
86831|NCT00939393|Secondary|Proportion of Participants With Post-operative Sinus Infections|Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).|52 weeks|||participants|||Number
86832|NCT00939393|Secondary|Proportion of Participants With Revisions (IO Only)|After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.|52 weeks|||participants|||Number
86833|NCT00939393|Secondary|Mean Number of Debridements Per Participant (IO Only)|A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.|52 weeks|||debridements||Standard Deviation|Mean
86834|NCT00939393|Secondary|Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)|Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.|Day 0|One (1) In-Office subject was missing data for this outcome measure.||participants|||Number
86835|NCT00939393|Secondary|Proportion of Participants Rating Procedure as Tolerable (IO Only)|Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.|Day 0|Eight (8) In-Office subjects were missing data for this outcome measure.||participants|||Number
86836|NCT00939393|Secondary|Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]|The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.|24 weeks|Eight (8) In-Office subjects and 15 Operating Room subjects were missing data for this outcome measure.||Scores on a scale||Standard Deviation|Mean
86837|NCT00939367|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng.hr/mL||Standard Deviation|Mean
86838|NCT00939367|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng.hr/mL||Standard Deviation|Mean
86839|NCT00939367|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.|||ng/mL||Standard Deviation|Mean
86840|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks|||Percentage of days||Standard Deviation|Mean
86841|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks|||Percentage of days||Standard Deviation|Mean
86842|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks|||Percentage of days||Standard Deviation|Mean
86843|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period|Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time|Baseline and 12 weeks|||Number of inhalations||Standard Deviation|Mean
86844|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Night-time Reliever Medication From run-in Period|Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks|||Number of inhalations||95% Confidence Interval|Mean
86845|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Day-time Reliever Medication From run-in Period|Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks|||Number of inhalations||95% Confidence Interval|Mean
86846|NCT00939341|Secondary|Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline|Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
86847|NCT00939341|Secondary|Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline|Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
86848|NCT00939341|Secondary|Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
86849|NCT00939341|Secondary|Change in AQLQ (S) Domain (Symptom) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
86850|NCT00939341|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
86851|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
86852|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
86853|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
86854|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (India)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
86855|NCT00939341|Secondary|Change in ACQ(5) Score From Baseline at Country Level (China)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.||Units on a scale||95% Confidence Interval|Mean
86856|NCT00939341|Primary|Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|||Units on a scale||95% Confidence Interval|Mean
86857|NCT00939211|Secondary|Plasma AZD9164 AUC0-24|Area under the AZD9164 plasma concentration curve|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|||nmol*h/L||Full Range|Geometric Mean
86858|NCT00939211|Secondary|Plasma AZD9164 Cmax|Maximum plasma concentration of AZD9164|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|||nmol/L||Full Range|Geometric Mean
86859|NCT00939211|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value|0, 30 min, 2 h, 4 h|||ms||Standard Deviation|Mean
86869|NCT00939185|Secondary|Compliance|"Compliance was assessed by the following questions: Question 1: Were the pediatrician’s instructions during the treatment phase followed (i.e. dose, frequency and number of days)?; Question 2: Was it easy to understand your pediatrician's instructions regarding treatment?; and Question 3: Was the administration of this drug easier than any other previously used drug? Patients could answer either yes, no, or Not applicable (NA)."|3 to 7 days after receiving treatment|Safety population||participants|||Number
86870|NCT00939185|Secondary|Number of Subjects Who Withdrew From the Study||3 to 7 days after receiving treatment|Safety Population. Please refer to the participant flow and AE sections for results pertaining to tolerability.||participants|||Number
86871|NCT00939185|Primary|Number of Patients With Adverse Events (AEs)|All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.|3 to 7 days after receiving treatment|Safety population = Those subjects who were known to have received at least one dose of the study treatment. Subjects who were dispensed study treatment and immediately lost to follow-up were not included among those known to have been dosed.||participants|||Number
86872|NCT00939159|Primary|Overall Response Rate Based on the Hematologic Improvement|"Overall response rate defined by International Working Group (IWG) response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets:~absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence ."|Assessment with 28-day cycle until response, then every 3 cycles as needed|Of the seventeen participants registered, four were not treated making thirteen evaluable for response.||Percentage of Participants|||Number
86873|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Storage Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
86874|NCT00939120|Secondary|International Prostate Symptoms Score, Voiding Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
86875|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Total|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
86876|NCT00939120|Secondary|Patient Perception of Bladder Condition (PPBC)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
86877|NCT00939120|Primary|Acute Urinary Retention (AUR)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||participants|||Number
86878|NCT00939120|Primary|Urine Voided Volume (Voiding)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||mL||Standard Error|Mean
86879|NCT00939120|Primary|Maximum Urine Flow Rate (Qmax).|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||mL/sec||Standard Error|Mean
86880|NCT00939120|Secondary|Overactive Bladder Questionnaire (OABq)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||units on a scale||Standard Error|Mean
86881|NCT00939120|Primary|Post-void Residual (PVR) Volume|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.||mL||Standard Error|Mean
86882|NCT00939107|Primary|Number of Patients With Treatment Success|Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)|Two months posttreatment|Intention to treat||participants|||Number
86883|NCT00939107|Secondary|Cost Effectiveness||twelve months posttreatment||08/2010||||
86886|NCT00939107|Secondary|Pain|The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items).|twelve months posttreatment|||Units on a scale||95% Confidence Interval|Mean
86887|NCT00939107|Primary|Disability|Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).|two months after treatment|Intention to treat||Units on a scale||95% Confidence Interval|Mean
86888|NCT00939094|Secondary|Change in BPI-SF Pain Interference From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.|28 days|||Scores on BPI-SF pain interference||Standard Error|Least Squares Mean
86889|NCT00939094|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.|28 days|||Scores (units) on BPI-SF pain severity||Standard Error|Least Squares Mean
86890|NCT00939094|Secondary|Change in SF-MPQ Affective Index From Baseline to Day 28|"Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days|||Scores (units) on SF-MPQ Affective Index||Standard Deviation|Least Squares Mean
86891|NCT00939094|Secondary|Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28|"Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days|||Scores (units) on SF-MPQ Sensory Index||Standard Error|Least Squares Mean
86892|NCT00939094|Secondary|Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” (Responder Rate) at Day 28|"PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of  much improved or very much improved Responder rate=(no. of responders/total no. of patients)*100"|28 days|||Patients|||Number
86893|NCT00939094|Secondary|Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100|28 days|||Participants|||Number
86894|NCT00939094|Secondary|Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100|28 days|||Participants|||Number
86895|NCT00939094|Primary|Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment|Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.|Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)|||Scores (units) on NRS||Standard Error|Least Squares Mean
86896|NCT00939055|Secondary|Quality of Life|Quality of life as assessed by the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite); a ≥ 10 total score improvement from baseline (screening) will represent a clinically significant improvement.|12 months|Secondary endpoint was not analyzed.|||||
86897|NCT00939055|Primary|Weight Loss|A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.|12 month|When futility analysis was performed, only 46 out of 108 patients had reached the 12 month primary endpoint. Analysis was performed on the 29 StomaphyX-treated patients to determine whether study objectives were met. Sham (control) patients were not analyzed.||participants|||Number
86898|NCT00939029|Secondary|Point-prevalence Abstinence at 6 Months|7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.|week 24|intention to treat||participants|||Number
86899|NCT00939029|Secondary|Point-prevalence Abstinence at 3 Months|7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml|week 12|intention to treat||participants|||Number
86900|NCT00939029|Primary|End of Treatment (Week 8) Point Prevalence Abstinence|7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml|weeks 8|intention to treat||participants|||Number
86901|NCT00939003|Other Pre-specified|Number of Participants Achieving a BASDAI50 Response During the Open-label Period|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)||participants|||Number
86916|NCT00938860|Secondary|Number of Participants With Dose Reduction or Discontinuation of Antiviral (AV) Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason|Defined as number of patients with dose reduction or discontinuation of AV therapy due to poor tolerability|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
86902|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS40 Response During the Open-label Period|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale of 0 to 100) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)||participants|||Number
86903|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS20 Response During the Open-label Period|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (as indicated by N)||participants|||Number
86904|NCT00939003|Secondary|Change From Baseline in SPARCC MRI Score for the Spine|"Six discovertebral units (DVU) representing the 6 most abnormal DVUs, and 3 consecutive sagittal slices at each DVU representing the most abnormal slices for that DVU were selected for scoring. Each DVU was divided into 4 quadrants and scored for the presence (1) or absence (0) of edema. The maximum score is 12 per DVU. The maximum score is 72 for 6 DVUs.~If edema was present in at least 1 quadrant of a DVU slice, it was scored for intensity and depth of the edema representing that slice:~A score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. The maximum score for intensity per slice is 1, per DVU is 3 and for 6 DVUs is 18.~A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the surface of the endplate in any quadrant. The maximum score per slice is 1, for a DVU is 3 and for 6 DVUs is 18.~The total maximum SPARCC score for all 6 DVUs is 108."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.||units on a scale||Standard Deviation|Mean
86905|NCT00939003|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints|"Six consecutive sacroiliac (SI) joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema using SPARCC scoring.~Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema; the maximum score is 8 per slice and maximum score for 6 SI joint slices is 48.~Intensity of edema: A score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice. The maximum score is 2 per slice and 12 for 6 slices.~A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The maximum score per slice is 2 and for 6 slices 12.~The total maximum score for all SI joints across 6 slices is 72."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.||units on a scale||Standard Deviation|Mean
86906|NCT00939003|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)|C-reactive protein (CRP) is considered an efficacy variable for the axial spondyloarthritis indication. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response. Higher levels indicate more inflammation.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline value were included. Last observation carried forward was used.||mg/L||Standard Deviation|Mean
86907|NCT00939003|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline values were included. Last observation carried forward was used.||units on a scale||Standard Deviation|Mean
86917|NCT00938860|Secondary|Number of Participants for Relapse Rate|Defined as reappearance of detectable Hepatitis C Virus (HCV) RNA at 24 weeks after completion of antiviral treatment when HCV RNA was undetectable at the end of treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
88722|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mmHg||Standard Deviation|Mean
86908|NCT00939003|Secondary|Number of Participants Achieving an ASAS5/6 Response|"ASAS5/6 response is a 20% improvement in five out of the following six domains:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hours or more duration).~Spinal mobility, measured from the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);~C-reactive protein level (lower levels indicate less inflammation)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
86909|NCT00939003|Other Pre-specified|Number of Participants With Blood Hematology or Chemistry Values Common Toxicity Criteria Grade ≥ 3|Blood was collected for analysis at designated study visits; hematology and chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher then upper normal limit or lower than lower normal limit) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. Results for the double-blind phase phase of the study are reported through Week 12.||participants|||Number
86910|NCT00939003|Other Pre-specified|Number of Participants Reporting Adverse Events|Adverse events were collected at designated study visits for all participants who received at least 1 dose of study drug. The number of participants experiencing any adverse event (serious and non-serious) is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. For the double-blind phase of the study, adverse events are reported through Week 12.||participants|||Number
86911|NCT00939003|Secondary|Number of Participants Achieving ASAS Partial Remission|"ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
86912|NCT00939003|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life. The SF-36 consists of 36 questions in 8 domains (limitations in physical functioning due to health problems; limitations in usual role because of physical health problems; bodily pain; general health perceptions; vitality; limitations in social functioning because of physical or emotional problems; limitations in usual role due to emotional problems; and general mental health). Two component scores can be summarized: physical and mental; domains 1-4 comprise the physical component summary of the SF-36. A transformed summary score is calculated ranging from 0 to 100 where higher scores indicate a higher level of functioning. A positive change from Baseline score indicates an improvement.|Baseline and Week 12|Full analysis set with available data||units on a scale||Standard Deviation|Mean
86913|NCT00939003|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
86914|NCT00939003|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants’ ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.||participants|||Number
86915|NCT00939003|Primary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale from 0 to 100) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants’ ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set. Participants with missing data at Week 12 were counted as non-responders (non-responder imputation).||participants|||Number
86918|NCT00938860|Secondary|Number of Participants of True Non-responder Rate|Defined as failure to achieve at least a 2 log reduction of Hepatitis C virus (HCV) RNA. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
86919|NCT00938860|Secondary|Number of Participants for the End of Treatment Response (ETR)|ETR defined as non-detectable HCV RNA at the completion of AV treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
86920|NCT00938860|Secondary|Number of Participants of Early Viral Response (EVR)|EVR defined as non-detectable HCV RNA or a ≥2 logs reduction of HCV RNA at 12 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 12|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
86921|NCT00938860|Secondary|Number of Participants of Rapid Viral Response (RVR)|RVR defined as non-detectable HCV RNA 4 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 4|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
86922|NCT00938860|Secondary|Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite, Participants showing an increase of Ishak Knodell fibrosis score by at least one level (increase of ≥1)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
86923|NCT00938860|Secondary|Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components|Efficacy failure (biopsy proven acute rejection (BPAR), graft loss, or death|Week 80|Intent-to-Treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Number of events|||Number
86924|NCT00938860|Primary|Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus|The achievement of SVR, defined as HCV RNA below limit of detection at the end of AV treatment, 24 weeks after end of AV treatment (W24 post). A dichotomous variable (SVR achieved: Yes/No) was computed. A patient was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at W24post, or at any time between W24 and completion of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated||Participants|||Number
86925|NCT00938782|Primary|Time to Extubation|The exact time from end of last anesthetic drug to time of tracheal extubation.|Measured from time of end anesthesia to time of tracheal extubation.|All patients enrolled in both groups.||minutes||Standard Deviation|Mean
86926|NCT00938717|Secondary|12-Week Percent of Abdominal Pain-free Days|"Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst.~Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Percent of Pain-free Days||Standard Deviation|Mean
86927|NCT00938717|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|A patient is considered to be an AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
86928|NCT00938717|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
87180|NCT00936702|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.|Time from registration to death or last follow-up (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).||months||95% Confidence Interval|Median
86929|NCT00938717|Secondary|12-Week Change in Bloating|"Bloating was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
86930|NCT00938717|Secondary|12-Week Change in Abdominal Discomfort|"Abdominal discomfort was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
86931|NCT00938717|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
86932|NCT00938717|Secondary|12-Week Change in Severity of Straining|"Straining is measured on a 5-point scale where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
86933|NCT00938717|Secondary|12-Week Change in Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||Units on a scale||Standard Error|Least Squares Mean
86934|NCT00938717|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||SBMs per Week||Standard Error|Least Squares Mean
86935|NCT00938717|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||CSBMs per Week||Standard Error|Least Squares Mean
86936|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks|"A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
86937|NCT00938717|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.~The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
86938|NCT00938717|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
86951|NCT00938639|Secondary|Duration of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
86939|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
86940|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Nasal) at Week 2|Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
86941|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Temporal) at Week 2|Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
86942|NCT00938704|Secondary|Change From Baseline in Corneal Staining at Week 2|Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
86943|NCT00938704|Secondary|Change From Baseline in Tear Breakup Time (TBUT) at Week 2|Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Seconds||Standard Deviation|Mean
86944|NCT00938704|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2|Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).||Scores on a Scale||Standard Deviation|Mean
86945|NCT00938639|Secondary|Frequency and Intensity of Unsolicited AEs|"Unsolicited AEs included AEs other than those specifically sought for.~The grading definitions were:~Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities.~Moderate (Grade 2): Enough discomfort to cause some interference with daily activities.~Severe (Grade 3): Incapacitating, with inability to work or do usual activities."|From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86946|NCT00938639|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86947|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
86948|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86949|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
86950|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
87213|NCT00936208|Primary|Change in Diastolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24||mmHg||Standard Deviation|Mean
86952|NCT00938639|Secondary|Frequency and Intensity of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86953|NCT00938639|Secondary|Duration of Solicited Local AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||days||Standard Deviation|Mean
86954|NCT00938639|Secondary|Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.||percentage of participants|||Number
86955|NCT00938639|Secondary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination||180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86956|NCT00938639|Secondary|GMFI in the HI Antibody Titre 180 Days After the Second Vaccination|The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.|21 days and 180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
86957|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure.~Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination)."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86958|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure.~Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the first (or second, as appropriate) study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86959|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86960|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86961|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
86962|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
86963|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86964|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86965|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86966|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86967|NCT00938639|Primary|GMFI in the HI and MN Antibody Titer After the Second Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
86968|NCT00938639|Primary|Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||geometric mean fold increase||95% Confidence Interval|Geometric Mean
86969|NCT00938639|Primary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86970|NCT00938639|Primary|Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).||percentage of participants||95% Confidence Interval|Number
86971|NCT00938548|Secondary|Pain Scores (VNRS) at 1 Week and 1 Month After Operation|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1 week, 1 month|||Units on a scale||Standard Deviation|Mean
88554|NCT00924833|Secondary|Peak Exercise Oxygen Saturation|Oxygen saturation by pulse oxymetry at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
86972|NCT00938548|Primary|Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.|1, 6, 24, 48 hour|||participants|||Number
86973|NCT00938548|Primary|Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1, 6, 24, 48 hour|||Units on a scale||Full Range|Median
86974|NCT00938457|Secondary|Evaluation of Cause of Death (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.|||||
86975|NCT00938457|Secondary|Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.|||||
86976|NCT00938457|Secondary|Refinement of Toxicity and Adverse Events Profile (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.|||||
86977|NCT00938457|Secondary|Median Time to Progression of Treated Tumors (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.|||||
86978|NCT00938457|Secondary|Local Control (LC) Cumulative Incidence Rates (Phase II)||3 and 6 months and 1, 2, and 5 years|No patients were accrued to the Phase II portion.|||||
86979|NCT00938457|Secondary|Radiographic Response Rate (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.|||||
86980|NCT00938457|Secondary|Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)||Up to 2 years||||||
86981|NCT00938457|Secondary|Toxicity and Adverse Events Profile (Phase I)|"Number of patients with a grade >= 3 adverse event.~Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Up to 2 years|||participants|||Number
86982|NCT00938457|Primary|Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)|LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.|At 1 year|No patients were accrued to the Phase II portion.|||||
86983|NCT00938457|Primary|Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.||2 months|Not enough patients were accrued to the Phase I portion to determine the MTD.|||||
86984|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 42|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
86985|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 35|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
86986|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 28|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
88723|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mmHg||Standard Deviation|Mean
86987|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 7|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
86988|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 42|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
86989|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 35|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
86990|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 28|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
86991|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 7|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."||μg/mL||Geometric Coefficient of Variation|Geometric Mean
86992|NCT00938431|Secondary|Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.~The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No Change~Minimally worse~Much worse~Very much worse"|Visit 5 (Day 27/28) or Early Termination|"This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.~For one subject in the age group >=12 years to <=17 years no data is available."||Participants|||Number
88724|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||mmHg||Standard Deviation|Mean
86993|NCT00938431|Secondary|Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status.~The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Visit 5 (Day 27/28) or Early Termination|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.||Participants|||Number
86994|NCT00938431|Secondary|Change in Seizure Frequency From Baseline to End of Treatment||From Baseline to End of Treatment (approximately 13 weeks)|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.||percentage change||Standard Deviation|Mean
86995|NCT00938431|Primary|Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)||13 weeks|The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.||participants|||Number
86996|NCT00938392|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.||Subjects|||Number
86997|NCT00938392|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESI)|AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.||Subjects|||Number
86998|NCT00938392|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.||Subjects|||Number
86999|NCT00938392|Secondary|Duration of Solicited Local and General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only.||Days||Full Range|Median
87000|NCT00938392|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed.||Subjects|||Number
87001|NCT00938392|Secondary|Number of Subjects Seroprotected for the 3 Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.||Subjects|||Number
87002|NCT00938392|Secondary|Seroconversion Factor for the 3 Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.||Fold Increase||95% Confidence Interval|Geometric Mean
87003|NCT00938392|Secondary|Number of Subjects Seroconverted for the 3 Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.||Subjects|||Number
87004|NCT00938392|Secondary|Number of Subjects Seropositive Against the 3 Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.||Subjects|||Number
87005|NCT00938392|Primary|Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains|Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.||Titer||95% Confidence Interval|Geometric Mean
87418|NCT00933543|Primary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||12 weeks after the first treatment|ITT||percentage of participants||95% Confidence Interval|Number
87006|NCT00938366|Secondary|Percentage of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1 year, that were absent before treatment or that worsened relative to pre treatment state. AEs Leading to Death and AEs Leading to Discontinuation were also presented in the outcome measure.|Up to 1 year|Safety analysis set included all the randomized subjects who received treatment with at least one dose of either cladribine or pantoprazole during the study period.||percentage of subjects|||Number
87007|NCT00938366|Other Pre-specified|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/f) of Cladribine|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||liter||Geometric Coefficient of Variation|Geometric Mean
87008|NCT00938366|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of Cladribine|Clearance of a drug was a measure of the rate at which cladribine is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||liter/hour||Geometric Coefficient of Variation|Geometric Mean
87009|NCT00938366|Secondary|Apparent Terminal Half-life (t1/2) of Cladribine|The apparent terminal half-life was defined as the time required for the plasma concentration of drug cladribine to decrease 50 percent (%) in the final stage of its elimination.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour||Geometric Coefficient of Variation|Geometric Mean
87010|NCT00938366|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Cladribine|The tmax was defined as time taken by the drug cladribine to reach Cmax.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour||Full Range|Median
87011|NCT00938366|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Cladribine|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
87012|NCT00938366|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Cladribine|The AUC (0-t) was defined as the area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
87013|NCT00938366|Primary|Maximum Plasma Concentration (Cmax) of Cladribine|The maximum or peak plasma concentration observed after the administration of cladribine.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|Pharmacokinetic (PK) analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
87014|NCT00938327|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (from Day 0 up to Day 30)|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
87015|NCT00938327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 – Day 30) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
87016|NCT00938327|Secondary|Number of Subjects Reporting Solicited General Symptoms|Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day|During the 8-day (Day 0 – Day 7) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
87017|NCT00938327|Primary|Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)|"Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C.~Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day."|During the 8-day (Day 0 – Day 7) follow-up period after each vaccination.|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
87018|NCT00938314|Secondary|Geriatric Depression Scale at Day 90|The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 – 5 is normal, whereas a score of 6 -15 suggests depression.|Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||scores on a scale||Standard Deviation|Mean
87019|NCT00938314|Secondary|Trails B Test Change From Baseline at Day 90|The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||seconds||Standard Deviation|Mean
87020|NCT00938314|Secondary|Trails A Test Change From Baseline at Day 90|The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||seconds||Standard Deviation|Mean
87021|NCT00938314|Secondary|Line Cancellation Test Change From Baseline at Day 90|The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||scores on a scale||Standard Deviation|Mean
87022|NCT00938314|Secondary|Boston Naming Test (BNT) Change From Baseline at Day 90|The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||Scores on a scale||Standard Deviation|Mean
87023|NCT00938314|Secondary|Gait Velocity Test Change From Baseline at Day 90|The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||seconds||Standard Deviation|Mean
87024|NCT00938314|Secondary|Action Research Arm Test (ARAT) Change From Baseline at Day 90|The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."||scores on a scale||Standard Deviation|Mean
87025|NCT00938314|Secondary|Barthel Index at Day 90|The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||Scores on a scale||Standard Deviation|Mean
87026|NCT00938314|Secondary|Modified Rankin Scale (mRS) Response <=2 at Day 90|The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response <=2 is defined as the mRS score <=2 at Day 90.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||participants|||Number
87027|NCT00938314|Secondary|NIHSS Change From Baseline at Day 30|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 30|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||scores on a scale||Standard Deviation|Mean
87028|NCT00938314|Secondary|NIHSS Response >=4 at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response >=4 is defined as a >=4 change from baseline at Day 90.|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||participants|||Number
87029|NCT00938314|Primary|National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.||scores on a scale||Standard Deviation|Mean
87030|NCT00938041|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population||Participants|||Number
87031|NCT00938041|Primary|Overall Survival|Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not die were censored at the date of their last contact in the study.||Months||95% Confidence Interval|Median
87032|NCT00938041|Primary|Time to Treatment Failure|Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.||Months||95% Confidence Interval|Median
87033|NCT00938041|Primary|Progression-free Survival|Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not progress or die were censored at their date of last contact in the study.||Months||95% Confidence Interval|Median
87034|NCT00938041|Primary|Duration of Response for All Confirmed Responders (CR + CCR + PR)|For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Only those participants with a confirmed CR, CCR, or PR were analyzed.||Months||95% Confidence Interval|Median
87035|NCT00938041|Primary|Number of Participants With Complete Response and Confirmed Complete Response|Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population: all participants who received at least one dose of study drug||Participants|||Number
87036|NCT00938015|Secondary|Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)|HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
87037|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
87038|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
87039|NCT00938015|Secondary|Number of Joints With Active Arthritis|Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.||Joints||Standard Deviation|Mean
87040|NCT00938015|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment||Baseline up to Month 78|Efficacy set included all the participants who signed ICF.||Percentage of participants|||Number
87051|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87419|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at baseline|Baseline|||mm||Standard Deviation|Mean
87041|NCT00938015|Secondary|Incidence of Adverse Events and Serious Adverse Events Per Participant-Year|Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.|Baseline up to Month 6, 12, 18, 30, 42, 54, 66|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.||Events per participant year|||Number
87042|NCT00938015|Secondary|Percentage of Participants With at Least 1 Adverse Event (AE) Per Year|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.||Percentage of participants|||Number
87043|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 5 up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
87044|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 4 up to Year 5|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
87045|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 3 up to Year 4|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
87046|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 2 up to Year 3|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
87047|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 1 up to Year 2|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants|||Number
87048|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Year 1|Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data.||Percentage of participants|||Number
87049|NCT00937950|Primary|Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87050|NCT00937950|Primary|Number of Subjects With AEs or SAEs Leading to Withdrawal|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87052|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87053|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 24|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjetcs|||Number
87054|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 12|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87055|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87056|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87057|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 24|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87058|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 12|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87059|NCT00937950|Primary|Number of Subjects With Cervical Cytology|Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87060|NCT00937950|Primary|Number of Subjects With Colposcopy Referral and Colposcopy Adequacy|Subjects with colposcopy referral and colposcopy adequacy.|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87061|NCT00937950|Primary|Number of Subjects With HPV DNA in Cervical Samples by HCII|Subjects that presented oncogenic HPV DNA in cervical samples by HPV DNA testing (Hybrid Capture® 2 test [HCII]).|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.||Subjects|||Number
87062|NCT00937937|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
87063|NCT00937937|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Disease assessments for response were performed every 6 weeks, up to 3 years|||percentage of participants||95% Confidence Interval|Mean
87064|NCT00937937|Secondary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.|Disease assessment was performed every 6 weeks, up to 3 years.|||months||95% Confidence Interval|Median
87065|NCT00937937|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years|||months||95% Confidence Interval|Median
87066|NCT00937833|Primary|Number of Continent Patients Post Prostatectomy||1 Month|||participants|||Number
87116|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
87067|NCT00937794|Primary|Number of Participants With a Score of at Least 90 on The General Conceptual Ability (GCA) Sub-Scale of The Differential Ability Scale (DAS)|The GCA sub-scale of the DAS, Second Edition (DAS-II) was used to obtain a general measure of cognitive ability.The maximum score is 120, with a higher score indicating greater cognitive ability. A score of 100 is considered an average score.|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.||participants|||Number
87068|NCT00937794|Primary|Number of Participants Who Were Screened For The Follow-On Study With an Investigational Agent|"Standardized tests were used to identify patients who were receiving treatment with Elaprase, had cognitive impairment, and were suitable to participate in the follow-on clinical study (HGT-HIT-045). Assessments included:~Cognition: The Differential Ability Scale, Second Edition (DAS-II) or the Bayley Scales of Infant Development, Third Edition (BSID-III);~Adaptive Behavior: The Scale of Independent Behavior-Revised (SIB-R);~Executive Function: The Behavior Rating Inventory of Executive Function-Preschool version (BRIEF-P) for children or the Behavior Rating Inventory of Executive Function (BRIEF) for children less than or ≥6 years of age, respectively;~Motor: The Peabody Developmental Motor Scales-2 (PDMS-2) or the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for children less than or ≥6 years of age, respectively."|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.||participants|||Number
87069|NCT00937768|Secondary|Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)||||||||
87070|NCT00937768|Secondary|Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate||||||||
87071|NCT00937768|Secondary|Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms||||||||
87072|NCT00937768|Secondary|Quality of Life as Assessed by the FACT-P and LASA Tool Within and Between the Two Treatment Arms||Baseline and months 3, 6, 9, 12, 15, 18, 21, and 24||||||
87073|NCT00937768|Secondary|Toxicity as Per NCI CTCAE Version 3||||||||
87074|NCT00937768|Secondary|Biochemical Progression-free Survival (BPFS), Overall Survival (OS), and Prostate Cancer Specific Survival (PCS)||||||||
87075|NCT00937768|Primary|Biochemical Progression-free Survival Rate||2 years|No participants reached the 2 years follow up due to the early termination of the trial.|||||
87076|NCT00937560|Secondary|Adverse Events, Cardiac Events, Lab Parameters, ECOG Performance Status, Vital Signs||Throughout study, laboratory and EOCG assessments every 3 weeks||||||
87077|NCT00937560|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised).|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Months||95% Confidence Interval|Median
87078|NCT00937560|Secondary|Overall Survival at 1 Year and 2 Years|Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.|Baseline to Year 2|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Percentage of participants||95% Confidence Interval|Number
87079|NCT00937560|Secondary|Duration of Response|Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Months||95% Confidence Interval|Median
87080|NCT00937560|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Percentage of participants||95% Confidence Interval|Number
87154|NCT00937040|Secondary|Responder Rate Using AISRS|AISRS responder rate is defined as the percentage of subjects with AISRS < 18 at endpoint.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set||Percent of participants|||Number
87420|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at 12 months|12 months|||mm||Standard Deviation|Mean
87081|NCT00937560|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).||Months||90% Confidence Interval|Median
87082|NCT00937547|Primary|HPV Type 51|Number of biopsies positive to HPV 51.|6 months|||biopsies|||Number
87083|NCT00937547|Primary|HPV Type 58|Number of biopsies positive to HPV 58.|6 months|||biopsies|||Number
87084|NCT00937547|Primary|HPV Type 45|Number of biopsies positive to HPV 45.|6 months|||biopsies|||Number
87085|NCT00937547|Primary|HPV Type 33|Number of biopsies positive to HPV 33.|6 months|||biopsies|||Number
87086|NCT00937547|Primary|HPV Type 31|Number of biopsies positive to HPV 31.|6 months|||biopsies|||Number
87087|NCT00937547|Primary|HPV Type 18|Number of biopsies positive to HPV 18.|6 months|||biopsies|||Number
87088|NCT00937547|Primary|HPV Type 16|Number of biopsies positive to HPV 16.|6 months|||biopsies|||Number
87089|NCT00937547|Primary|HPV Identification|HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer|6 months|||biopsies|||Number
87090|NCT00937521|Secondary|Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group|To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.|Day 1 through day 7 at 13 months age.|The analysis was performed on the safety population.||Subjects|||Number
87091|NCT00937521|Secondary|Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.|Overall study period.|The analysis was performed on the safety population.||Subjects|||Number
87092|NCT00937521|Secondary|Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.||Subjects|||Number
87093|NCT00937521|Secondary|Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.||Subjects|||Number
87094|NCT00937521|Primary|Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination|To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.|Day 1 to day 3 after first vaccination.|The analysis was done on the Safety Population.||Subjects|||Number
87095|NCT00937521|Secondary|Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.||Subjects|||Number
87096|NCT00937521|Secondary|Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination|To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).|Day 1 through day 7 after second and third vaccination.|As per safety dataset.||Subjects|||Number
87097|NCT00937521|Secondary|Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)|To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).|1 month after booster|The analysis was done on the Per Protocol population.||Percentage of Subjects||95% Confidence Interval|Number
87098|NCT00937521|Secondary|Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)|To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.|At 13 months|The analysis was done on the Per Protocol population.||Titers||95% Confidence Interval|Geometric Mean
87099|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)|To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.|1 month after fourth vaccination|The analysis was done on the Per Protocol Booster population.||Percentages of Subjects||95% Confidence Interval|Number
88725|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||mmHg||Standard Deviation|Mean
87100|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)|To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.|12 months (pre-fourth vaccination)|The analysis was done on the Per Protocol Booster population.||Percentages of Subjects||95% Confidence Interval|Number
87101|NCT00937521|Secondary|Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).|After the third and the booster vaccination.|As per PP population.||Ratios||95% Confidence Interval|Geometric Mean
87102|NCT00937521|Secondary|Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.|At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days|As per PP population.||Titers||95% Confidence Interval|Geometric Mean
87103|NCT00937521|Secondary|Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)|"ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:~One month after third vaccination.~One month after booster vaccination (Men B at 12 months of age)."|At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)|Per Protocol Primary and Booster populations.||Titers||95% Confidence Interval|Geometric Mean
87104|NCT00937521|Primary|Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination|To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination.|Analysis as per PP population.||Percentages of Subjects||95% Confidence Interval|Number
87105|NCT00937495|Secondary|Overall Survival|The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 2 years|||months||95% Confidence Interval|Median
87106|NCT00937495|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the time of progression or death, whichever comes first. The distribution and median of progression-free survival times will be estimated using the method of Kaplan-Meier.|Up to 2 years|||months||95% Confidence Interval|Median
87107|NCT00937495|Primary|Confirmed Tumor Responses|"The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years|||participants|||Number
87108|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1|Within 5 minutes after injection|Full analysis set||Participants|||Number
87109|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1|Within 5 minutes after injection|Full analysis set||Participants|||Number
87110|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2|For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.|Within 5 minutes after injection|Full analysis set||Participants|||Number
87111|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1|For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.|Within 5 minutes after injection|Full analysis set||Participants|||Number
87112|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 2|For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)||Participants|||Number
87113|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 1|For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)||Participants|||Number
87114|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 2|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
87115|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 1|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
88726|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||mmHg||Standard Deviation|Mean
87117|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator.|Within 5 minutes after injection|Full analysis set||Participants|||Number
87118|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
87119|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set||Participants|||Number
87120|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set||Participants|||Number
87121|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set||Participants|||Number
87122|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set||Participants|||Number
87123|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set||Participants|||Number
87124|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set||Participants|||Number
87125|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set||Participants|||Number
87126|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 2|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set||Participants|||Number
87127|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 1|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set||Participants|||Number
87128|NCT00937391|Primary|PK Analysis - t 1/2|t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity|Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||hour||Full Range|Median
87129|NCT00937391|Primary|PK Analysis - Area Under the Drug Concentration-time Curve (AUC)|AUC = Area under the drug concentration-time curve from administration to infinity|Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||µmol•hour/Liter||Full Range|Median
87130|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)|Vss/BW = volume of distribution at steady state normalized by body weight|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters/kg||Full Range|Median
87178|NCT00936702|Secondary|Duration of Response|Duration of response was defined for all evaluable participants who have achieved an objective response as the date at which the participant's objective status is first noted to be either CR or PR to the date progression is documented.|Up to 3 years|All eligible participants who have achieved an objective response at which the participant's objective status is first noted to be either CR or PR.||months||95% Confidence Interval|Median
87131|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss)|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters||Full Range|Median
87132|NCT00937391|Primary|PK Analysis - Total Clearance (CL)/Body Weight (BW)|CL/BW = total clearance normalized by BW|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters/hour/kg||Full Range|Median
87133|NCT00937391|Primary|PK Analysis - Total Clearance (CL)|Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples||Liters/hour||Full Range|Median
87134|NCT00937391|Primary|Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers|For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.|Within 5 minutes after injection|Primary Analysis Set (the first 5 PPS participants in each age group)||Participants|||Number
87135|NCT00937391|Primary|Dose Determined by Blinded Readers to be Superior for Diagnosis|Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters|Within 5 minutes after injection|Primary analysis set (the first 5 PPS participants in each age group)||Participants|||Number
87136|NCT00937391|Primary|Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)|"A clinical judgment by the open-label Clinical Investigators (CIs) as to whether (yes) or not (no) the CI could make a diagnosis from the image."|Within 5 minutes after injection|The first 3 participants of Stage 1 received 2 IV injections of 0.05 mmol/kg body weight (BW), images were obtained after each injection and an assessment made by the CIs as to diagnostic adequacy.||Participants|||Number
87137|NCT00937157|Secondary|To Determine the Correlation of MTI and Cumulative Gd Enhancing Lesions Using the 1.5T and 3T Protocols.||day 0, 3, 6, 9 & 12 months||||||
87138|NCT00937157|Primary|A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.||0-180 days and 0-360 days|Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.||Cumulative GAD lesions (number of)||Standard Deviation|Mean
87139|NCT00937118|Primary|Duodenal-related Complications|Duodenal-related complications including leak, obstruction, and abscess|20 years|Patients with duodenal related complications||percentage of subjects|||Number
87140|NCT00937105|Secondary|Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins|Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids|up to 1 year|All participants in which valid lids bioburden data was available||participants|||Number
87141|NCT00937105|Secondary|Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins|Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids|up to 1 year|All participants in which valid lens bioburden data was available||participants|||Number
87142|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases|Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora|up to 1 year|All participants in which valid lens case bioburden data was available||participants|||Number
87143|NCT00937105|Secondary|Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.|Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones|up to 1 year|Number of participants with valid presumed solution induced corneal staining data in each group||participants|||Number
87144|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lenses|Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses|up to 1 year|All participants in which valid lens bioburden data was available||participants|||Number
87145|NCT00937105|Primary|Number of Participants Developing a Corneal Inflammatory Event (CIE)|Raw number of participants in each solution arm developing CIE over 12 month follow-up period|up to 1 year|This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.||participants|||Number
87179|NCT00936702|Secondary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of registration to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from registration to the disease progression or death (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).||months||95% Confidence Interval|Median
88727|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||mmHg||Standard Deviation|Mean
87146|NCT00937040|Secondary|Epworth Sleepiness Scale (ESS)|The Epworth Sleepiness Scale (ESS) is an 8-item self-rated questionnaire designed to assess the overall level of daytime sleepiness. Each item describes normal daily situations (i.e., watching TV, lying down in the afternoon, sitting inactive in a public place) and subjects rate the likelihood of dozing off or falling asleep in each situation. Responses use a 4-point rating scale (0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing). Item scores are summed to produce a total score (range of 0-24) with lower score suggesting more alertness.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87147|NCT00937040|Secondary|Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI discriminates between good and poor sleepers. The self-administered scale contains 15 multiple-choice items concerning frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration over the past month. The PSQI generates 7 scores corresponding to the different sleep domains. Each component score ranges from 0 to 3. Total sleep index is calculated by adding up the 7 component scores (low=0, high=21, the lower the score, the better in sleep quality).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87148|NCT00937040|Secondary|Adult ADHD Self-Report Scale (ASRS) Over Time|The Adult ADHD Self-Report Scale (ASRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the subject's own rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87149|NCT00937040|Secondary|Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires the subject’s DO to answer 4 questions related to how much the subject’s ADHD symptoms have changed since starting the medication, how much benefit was received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. Responses vary from extremely satisfied, very satisfied, satisfied, neutral, mildly dissatisfied, dissatisfied, very dissatisfied, or extremely dissatisfied.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question||Participants|||Number
87150|NCT00937040|Secondary|Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale|The Dyadic Adjustment Scale (DAS) completed by DOs who were spouses or significant others assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. Possible responses include 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question DAS subset, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87151|NCT00937040|Secondary|Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A, as completed by the DO, is a measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of an adult informant familiar with the subject’s functioning. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in nine non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and Global Executive Composite (GEC) are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87152|NCT00937040|Secondary|Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV|The ADHD Rating Scale-IV (Significant Other) is an 18-item list of core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms. Each item is rated on a four point Likert type scale (0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often). The subject’s designated observer will complete this scale, with baseline assessment based on the subject’s usual functioning when not on medication. The total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set and non-missing values at each timepoint. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87153|NCT00937040|Secondary|Clinical Global Impression - Severity of Illness Subscale (CGI-S)|The Clinical Global Impression - Severity of Illness (CGI-S) is a clinician-rated subscale (low=0, high=7, higher score indicates increasing illness). The clinician rates the severity of the ADHD symptoms in relation to the clinician’s total experience with ADHD subjects using a 7-point scale (1=normal, not at all ill, 2= borderline ill, 3= mildly ill, 4=moderately ill, 5= markedly ill, 6= severely ill, 7= among the most extremely ill subjects) in response to the question “Considering your total clinical experience with this particular population, how ill is the subject at this time?”.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87155|NCT00937040|Secondary|Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires subjects to answer 4 questions related to how much their ADHD symptoms have changed since starting the medication, how much benefit they received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. The responses for this question vary with range of satisfaction (e.g. extremely satisfied, very satisfied, satisfied, neutral, dissatisfied, very dissatisfied, or extremely dissatisfied).|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question||Participants|||Number
87156|NCT00937040|Secondary|Subject's Rating of Dyadic Satisfaction Subscale (DSS)|The Dyadic Adjustment Scale (DAS) assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. The response format varies across the entire scale and includes 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question subset of the DAS, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87157|NCT00937040|Secondary|Subject's Rating of Endicott Work Productivity Scale (EWPS)|The EWPS provides a measure of the subject’s report of their overall productivity (low=0, high=100, a higher score indicates worsening work productivity and efficiency). There are 25 items (questions 15-39) on the scale that describe types of behaviors/ subjective feelings that are highly likely to reduce work productivity/efficiency. These 25 items are rated on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, to 4=almost always) indicating how often the behavior, feeling or attitude has been manifested in the past week. The total score is the sum of the 25 items.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87158|NCT00937040|Secondary|Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A)|The AIM-A is a subject-reported measure (low=0, high=100, a higher score is more favorable) to assess the overall impact and role that ADHD may have in the conduct of tasks that are expected of adults. The AIM-A is comprised of four global quality of life items, five economic impact items, and five multi-item scales that describe important concepts. Items include: Living with ADHD; General Well-Being; Work, Home and School Performance and Daily Functioning; Relationships; and Communication; and Impact of Symptoms (emotional, degree of daily interference).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87159|NCT00937040|Secondary|Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A is a self-reported measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of the subject's own functioning in the everyday environment. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in 9 non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and GEC are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||units on a scale||Standard Deviation|Mean
87160|NCT00937040|Secondary|Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function)|The Symbol Digit Modalities Test (SDMT) is a computerized variant of the Wechsler Digit Symbol Substitution Test (DSST), but the position of symbols and digits is reversed. Scoring is the number of correct responses generated in 2 minutes. Processing Speed Domain = SDMT correct responses - SDMT errors. Higher scores indicate better functioning (i.e. information processing).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||acccurate responses per minute||Standard Deviation|Mean
87161|NCT00937040|Secondary|Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The SAT is a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The scores generated by the SAT are: correct matches, errors, and response time. The testing score is a measure of cognitive flexibility. Cognitive Flexibility Domain Score = SAT Correct Responses - SAT Errors - Stroop Commission Errors. Higher scores indicate better accuracy.|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||correct responses||Standard Deviation|Mean
87162|NCT00937040|Secondary|Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The Shifting Attention Test (SAT) a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The Continuous Performance Test (CPT) is a computerized measure of vigilance or sustained attention/attention over time. Vigilance Domain (Complex Attention) Score = Stroop Commission Errors + SAT Errors + CPT Commission Errors + CPT Omission Errors. Lower scores indicate better functioning (i.e. sustained attention).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||errors||Standard Deviation|Mean
87163|NCT00937040|Secondary|Reaction Time Domain of the Stroop Test (Cognitive and Executive Function)|"Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The 1st part generates basic reaction time to colors. The 2nd part generates complex reaction time score to matching color names and font color. The 3rd part establishes a Stroop reaction time and an error score to unmatched color names/fonts. Reaction Time Domain Score = (Stroop Complex Reaction Time Correct + Stroop Reaction Time Correct)/2. Lower scores indicate better functioning (i.e. reaction time)."|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.||milliseconds (msec)||Standard Deviation|Mean
87164|NCT00937040|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis|The Adult ADHD Investigator Symptom Rating Score (AISRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the investigator’s rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The AISRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set was defined as all randomized subjects who have received at least one dose of the study medication and have any post-baseline efficacy data (not including ASRS).||units on a scale||Standard Deviation|Mean
87165|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Normal|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis.|Baseline and 12 weeks|||mL/min/mL|Participants|Standard Deviation|Mean
87166|NCT00936975|Primary|Changes in 18F-fluoride Ki - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||mL/min/mL|Participants|Standard Deviation|Mean
87167|NCT00936975|Primary|Changes in 18F-fluoride Ki - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 Tumor bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||mL/min/mL|Participants|Standard Deviation|Mean
87168|NCT00936975|Primary|Changes in 18F-fluoride PET SUV - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 normal bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||SUVmax|Participants|Standard Deviation|Mean
87169|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant.|Baseline and 12 weeks|||mL/min/mL|Participants|Standard Deviation|Mean
87170|NCT00936975|Primary|Changes in 18F-fluoride PET (SUV) - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans||SUVmax|Participants|Standard Deviation|Mean
87171|NCT00936897|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data||Percentage Change From Baseline||95% Confidence Interval|Mean
87172|NCT00936897|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to Month 12|All randomized subjects using regression imputation for missing post baseline data||Percentage Change From Baseline||95% Confidence Interval|Mean
87173|NCT00936897|Secondary|Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1||Baseline to month 1|Randomized subjects who enrolled in the bone marker substudy||Percentage Change From Baseline||Inter-Quartile Range|Median
87174|NCT00936897|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data.||Percentage Change From Baseline||95% Confidence Interval|Mean
87175|NCT00936741|Secondary|The Long-term Benefit of Mifepristone Treatment in Cushing’s Syndrome as Measured by Changes in the Score on the Physician’s Global Assessment of Disease Severity|"The mean Investigator’s rating of the change in subject’s signs and symptoms of Cushing’s syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician’s Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.~The instruction was Rate the change in the subject’s signs and symptoms of Cushing’s from Baseline (1 = much better to 9 = much worse)."|Up to three years.|||units on a scale||Standard Deviation|Mean
87176|NCT00936741|Primary|Number of Participants With Adverse Events|Subjects who received at least one dose of mifepristone were included in the safety analysis.|Up to three years.|Subjects who received one dose of study drug were included in the safety and ITT analyses.||participants|||Number
87177|NCT00936702|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from the date of registration to the date at which the participant is removed from treatment due to progression, adverse events, or refusal.|Up to 3 years|All participant who has been removed from treatment due to progression, adverse events, or refusal.||months||95% Confidence Interval|Median
87181|NCT00936702|Primary|Percentage of Participants With Confirmed Tumor Responses|Confirmed tumor response was defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.|First 6 Cycles of treatment|All participants except one who was deemed ineligible (treated prior to registration).||percentage of participants||95% Confidence Interval|Number
87182|NCT00936598|Secondary|Daily Analgesic Medication Consumption (Morphine Equivalency)|Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.|daily from the day of surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.|||||
87183|NCT00936598|Secondary|Pain Severity Visual Analogue Scale|"Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain as bad as it could be."|each of the days following surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.|||||
87184|NCT00936598|Primary|Brief Pain Inventory (Short-form)|Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).|at the clinical follow-up appointment approximately 7-10 days after surgery|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.|||||
87185|NCT00936585|Primary|Immunologic Data|Changes in immunological parameters in blood and lamina propria immune cells|Baseline, 6 weeks|All patients in the study were enrolled; not enough patients were enrolled to get enough data to analyze - THERE IS NO DATA as the samples were not processed because not enough patients were enrolled to make any comparison.|||||
87186|NCT00936481|Secondary|Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls.||at initial visit|||mm||Standard Deviation|Mean
87187|NCT00936481|Primary|Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls.||at the initial visit|||IU/ml||Standard Error|Mean
87188|NCT00936455|Secondary|Functional Outcome (mRS(0-1)) at 12 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 12 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
87189|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
87190|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
87191|NCT00936455|Primary|Functional Outcome (mRS(0-1)) at 6 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 6 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE||participants|||Number
87192|NCT00936377|Secondary|ICU Length of Stay||The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks|||days||Inter-Quartile Range|Median
87193|NCT00936377|Secondary|Duration of Study Drug Administration||The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks|||hours||Inter-Quartile Range|Median
87194|NCT00936377|Secondary|Plasma Epinephrine Concentrations Across Groups Over Time|Plasma epinephrine concentrations|Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug|||ng/mL||Standard Deviation|Mean
87195|NCT00936377|Secondary|The Occurrence of Adverse Events.|Occurrence of hypotension or bradycardia while on study drug|Seven days|||participants|||Number
87235|NCT00936065|Secondary|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data||units on a scale||Standard Deviation|Mean
87196|NCT00936377|Secondary|The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores|Proportion of clinical institute withdrawal assessment (CIWA) Scores listed as severe or moderate 24 Hours after Starting Study Drug. All subjects had at least four CIWA assessments.The CIWA is a ten item scale with each item on the scale scored independently on a 0-7 or 0-4 scale, and the summation of the scores yielding an aggregate value that correlates to the severity of alcohol withdrawal. Ranges of scores are from 0 to 67. Mild alcohol withdrawal is defined with a score less than or equal to 15, moderate with scores of 16 to 20, and severe with any score greater than 20. The ten items evaluated include nausea and vomiting, tremor, sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation.|Every 2-4 hours for 24 hours after starting study drug|||percentage of ciwa assessment|||Number
87197|NCT00936377|Primary|Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment||24 hours before treatment, 24 hours after treatment on first day of starting study drug|||mg||Inter-Quartile Range|Median
87198|NCT00936377|Primary|Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment||12 hours before treatment, 12 hours after treatment on first day of starting study drug|||mg||Inter-Quartile Range|Median
87199|NCT00936377|Primary|Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal||Seven days|||mg||Inter-Quartile Range|Median
87200|NCT00936351|Primary|Weeks|Vocational rehabilitation staff tracked weekly work hours verified by supervisors and reported the data to study staff during the 24-week interventions. Therefore possible values for total weeks worked range from 1-24.|weeks 1-24|||total number of weeks||Standard Deviation|Mean
87201|NCT00936351|Primary|Work Behavior Inventory|"The Work Behavior Inventory (WBI: Bryson, et al., 1997) assesses work performance for persons with severe mental illness based on a trained rater’s observation of participants at work and an interview with their supervisor. Each of the 35 WBI items are rated as 1- 5 (“persistent problem area” to “frequent area of strength”). The total score is the sum of five sub-scales (social skills, cooperativeness, work habits, work quality, and personal presentation). We divided the total score by 35 to produce a mean score that is conducive to interpretation since there are no established cut-offs for interpretation of the total score. Thus the mean scores range from 1-5 and are interpretable based on the anchors for the likert scale ranging from 1 (persistent problem area to 5 (frequent area of strength). Good to excellent interrater reliability was found for raters in this study, with intraclass correlations of .79-.98."|week 24|||units on a scale||Standard Deviation|Mean
87202|NCT00936351|Primary|Hours|total hours worked over the duration of the 24-week treatment|week 1 through week 24 of treatment|3 participants were not included due to early dropout||total hours worked during treatment||Standard Deviation|Mean
87203|NCT00936221|Secondary|Change in Target Lesion Tumour Size at Week 12||randomization to week 12|Intention to Treat (ITT)||% change||Full Range|Median
87204|NCT00936221|Secondary|Objective Response Rate|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)||Participants|||Number
87205|NCT00936221|Secondary|Progression Free Survival|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)||Days||Full Range|Median
87206|NCT00936221|Primary|Overall Survival|Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.|From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later|Intention to Treat (ITT)||Days||Full Range|Median
87207|NCT00936208|Secondary|Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)|The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the dipstick test at baseline and at week 24||participants|||Number
87208|NCT00936208|Secondary|Change in the IRIS II Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
87209|NCT00936208|Secondary|International Renal Interest Society (IRIS) II Score at Week 24|The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
87210|NCT00936208|Secondary|Change in the Framingham Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
87211|NCT00936208|Secondary|Framingham Score at Week 24|The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24||Units on a scale||Standard Deviation|Mean
87212|NCT00936208|Primary|Change in Systolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24||mmHg||Standard Deviation|Mean
87214|NCT00936117|Primary|Maximum Observed Concentration in Plasma (Cmax)|"Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day.~Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 – 5000 ng/ml. There are no established therapeutic ranges for posaconazole."|Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.|Of the 11 females enrolled, one was not evaluable for the outcome thus excluded from analysis.||ng/ml||Full Range|Median
87215|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
87216|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Percentage of participants||95% Confidence Interval|Number
87217|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement I would like to continue with my current psoriasis treatment. Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87218|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87219|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87220|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87221|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87222|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87223|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87224|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87225|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87226|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87227|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87228|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87229|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87230|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87231|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87232|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Units on a scale||Standard Deviation|Mean
87233|NCT00936065|Secondary|Change From Baseline in SGA of Itching at Each Visit|Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data||units on a scale||Standard Deviation|Mean
87234|NCT00936065|Secondary|Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data||units on a scale||Standard Deviation|Mean
87236|NCT00936065|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24|Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of BSA||Standard Deviation|Mean
87237|NCT00936065|Secondary|Change From Baseline in the PASI Score|Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90–100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||units on a scale||Standard Deviation|Mean
87238|NCT00936065|Secondary|Change From Baseline in the PGA of Psoriasis|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF||units on a scale||Standard Deviation|Mean
87239|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
87240|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
87241|NCT00936065|Secondary|Time to Achieve a PASI 75 Score|PASI 75 defined as a 75% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
87242|NCT00936065|Secondary|Time to Achieve a PASI 50 Score|PASI 50 defined as a 50% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT||days||95% Confidence Interval|Median
87243|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
87244|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
87245|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF||Percentage of participants||95% Confidence Interval|Number
87246|NCT00936065|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF||percentage of participants||95% Confidence Interval|Number
87247|NCT00936065|Primary|Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)||percentage of participants||95% Confidence Interval|Number
87248|NCT00935883|Secondary|Change in Visual Acuity for Geographic Atrophy Group||Baseline/ 6 Months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||letters||Standard Deviation|Mean
87250|NCT00935883|Secondary|Change in Visual Acuity for Drusen Group|ETDRS (Early Treatment Diabetic Retinopathy Studies) letters ETDRS is a widely accepted clinical vision research tool used to check a patient's vision which is preferred to the Snellen chart.|Baseline/ 6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||letters||Standard Deviation|Mean
87251|NCT00935883|Primary|Growth of Geographic Atrophy||6 months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab||millimeters||Standard Deviation|Mean
87252|NCT00935857|Secondary|Procedural Complications|Number of patients with any procedural complications as assessed 7 days after procedure.|7 days post procedure|||participants|||Number
87253|NCT00935857|Secondary|Time (Minutes) to Cecum|Time, in minutes, until reaching cecum in each arm.|Day of Procedure|||minutes||Standard Deviation|Mean
87254|NCT00935857|Primary|Complete Colonoscopy to the Cecum|Number of patients with a complete colonoscopy to the cecum|Day of Procedure|Per Protocol, Terminated at Interim Analysis||patients|||Number
87255|NCT00935818|Secondary|Point Prevalence Abstinence at 12 Months|Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days|12 months|||participants|||Number
87256|NCT00935818|Secondary|Prolonged Abstinence at 12 Months||12 months|intention to treat - all subjects||participants|||Number
87257|NCT00935818|Secondary|Point Prevalence Abstinence at 6 Months.|Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.|6 months|Intention to treat - all subjects||participants|||Number
87258|NCT00935818|Primary|Point Prevalence Abstinence at 3 Months.|biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.|3 months|intent to treat - all subjects||participants|||Number
87259|NCT00935818|Secondary|Weight Gain From Baseline to 3 Months|Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit|3 months|analysis was restricted to subjects who had weight measured at the 3 month visit and were classified as meeting criteria for prolonged abstinence||kilograms||Standard Deviation|Mean
87260|NCT00935818|Secondary|Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.||6 months|intention to treat - all subjects||participants|||Number
87261|NCT00935818|Primary|Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.|Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question “Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”|3 months|intention-to-treat (all randomized subjects included)||participants|||Number
87262|NCT00935792|Secondary|Time to Subsequent Therapy||up to 5 years|||Months||95% Confidence Interval|Median
87263|NCT00935792|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient’s objective status is first noted to be a Complete Response or Partial Response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier|up to 5 years|These are 8 patients with verified complete or partial responses(used in primary outcome measure) as well as 2 non verified partial responses.||Months||95% Confidence Interval|Median
87264|NCT00935792|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier|up to 5 years|||Months||95% Confidence Interval|Median
87265|NCT00935792|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|up to 5 years|||Months||95% Confidence Interval|Median
87266|NCT00935792|Primary|Test the Safety and Tolerability of the Combination of Everolimus and Alemtuzumab.|The number and severity of all adverse events will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination in this patient group. Below is the number of patients that experienced a grade 3+ Adverse event that was at least possibly related to Treatment.|Up to 12 months past final treatment|||participants|||Number
87267|NCT00935792|Primary|Number of Participants With Dose-Limiting Toxicities|"The maximum tolerated dose is the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. Dose-limiting toxicity will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria.~Hematologic: ANC ≤ 0.3 x 109/L or platelet count < 10 x 109/L Other nonhematologic: ≥grade 3 as per NCI Common Terminology Criteria for Adverse Events v3.0 except for fatigue, hyperlipidemia, and hyperglycemia."|1 Month|All phase 1 patients are evaluable||participants with DLTs|||Number
87268|NCT00935792|Primary|Clinical Response (Complete or Partial Remission)|CR requires all of the following for a period of at least 2months:Absence of lymphadenopathy.No hepatomegaly or splenomegaly.Absence of constitutional symptoms.• Neutrophils>1500/ul•Platelets>100,000/ul • Hemoglobin >11.0gm/dl• Peripheral blood lymphocytes <4000/uLBonemarrow. normocellular with<30%of nucleated cells being lymphocytes.PR requires two for 2+months.≥50%decrease in peripheral blood lymphocyte count from the pretreatment baseline value.≥ 50%reduction in the sum of the products of the maximal perpendicular diameters of the largest measured node or nodal masses in the right and left cervical, axillary, and inguinal lymph node regions.≥ 50%reduction in size of liver and/or spleen noting the maximal distance below the respective costal margins of palpable hepatosplenomegaly during rest.Neutrophils>1500/ul or50%improvement over baseline. Platelets>100,000/ul or50%increase over baseline. Hemoglobin>11.0 gm/dl or50%increase over baseline without transfusions|After 2 courses of treatment|All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.||participants|||Number
87269|NCT00935766|Primary|Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients.|We conducted a prospective, randomized; double-blinded study of omega-3 fatty acids among 60 Latino and White hypertensive patients at risk for CVD. Patients received either 4-g omega–3 fatty acids or matched placebo daily. The principal outcome measure was change in brachial-ankle PWV.|Baseline, 3 months|||cm/sec||Standard Deviation|Mean
87270|NCT00935766|Secondary|Change in hsCRP||baseline, 3 months|||mg/L||Standard Deviation|Mean
87272|NCT00935701|Secondary|Change in Parenting Stress Index|The Parenting Stress Index (PSI) was designed for parents of children ages 1:6 to 12:5 and identifies stressors in the parent-child relationship. Specifically, the PSI measures child’s characteristics on six subscales, which are summed get a total score in the child domain (47 to 235). The PSI also has seven subscales that measure parent characteristics, and are summed to get a total score in the parent domain (54 to 270). The totals from the parent and child domains are summed for a total stress score (101 to 505). Higher scores indicate a higher level of stress. Pre scores were subtracted from post scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
87273|NCT00935701|Secondary|Change in Children's Sleep Habits Questionnaire|The Children’s Sleep Habits Questionnaire (CSHQ) assesses sleep problems common in school-age children and is comprised of eight subscales. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. Subscale scores from pre intervention were subtracted from post subscale scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)|||units on a scale||Standard Deviation|Mean
87274|NCT00935701|Secondary|Change in Conners' Rating Scales|The Conners’ Rating Scales Revised (CRS-R) is used to assess attention deficit hyperactivity disorder (ADHD) as well as other related behavioral concerns. The CRS-R is made up of 14 scales. Analysis was done on 6 of these scales: Conners' Global Index Restless-Impulsive, Conners' Global Index Emotional Lability, Conners' Global Index Total, DSM-IV Inattentive, DSM-IV Hyperactive-Impulsive, and DSM-IV Total. Raw scores are converted to T-scores, based on age and gender of the child. A high T-score indicates a greater number and/or frequency of reported concerns. Pre T-scores were subtracted from post T-scores to calculate the change in T-score.|Pre intervention (baseline), post intervention (8 weeks)|||t-scores||Standard Deviation|Mean
87275|NCT00935701|Primary|Proportions of Children Completing Acupressure and Acupuncture Treatment.||2 months into Phase 1|Participants who transitioned from acupressure to acupuncture were assessed.||participants|||Number
87276|NCT00935649|Secondary|Mycology|KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.|||||
87277|NCT00935649|Primary|Nail Bed Clearing|Change in amount of clear nail over time.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.|||||
87278|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Median/Range)|For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per minute per visit||Full Range|Median
87279|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)||Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per minute per visit||Standard Deviation|Mean
87280|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Median/Range)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per visit||Full Range|Median
87281|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use. Mean and standard deviation of outcome were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n= 60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.||EMR mouse clicks per visit||Standard Deviation|Mean
87282|NCT00935584|Primary|Change in Patient Engagement|Change in proportion of time spent on physician-patient communication from pre to post-intervention clinic visit was calculated. Positive change indicates increased time spent on patient communication. Mean and standard deviation of outcomes were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=72 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=125) using all available data.||percentage of total visit time||Standard Deviation|Mean
87296|NCT00935493|Secondary|Quality of Life (SF-36 MCS)|"Quality of Life (QOL) was assessed using the SF-36 (36-Item Short-Form Health Survey; QualityMetric, Lincoln, RI), MCS subscale. The SF-36 is a self-administered general health-related quality of life scale with 36 items. The MCS subscale has been shown to be responsive in psychoactive drug trials. The score range is 0-100.~Higher scores represent better mental health; therefore, the least squares means listed here represent mean outcome changes from baseline."|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow up||units on a scale||Standard Error|Least Squares Mean
87308|NCT00935259|Secondary|Fasting Blood Lipidomic Levels After 2 Weeks of Treatment|"Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.~The mean reported was an adjusted mean."|2 weeks|"Only participants with complete blood lipidomic data were included.~For cholesterol ester 22:5n6, n=26 for the simvastatin arm and n=27 for the placebo arm."||nmol||Standard Deviation|Mean
87283|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.~Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Median and range were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.||units on a scale||Full Range|Median
87284|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.~Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Mean and standard deviation were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.||units on a scale||Standard Deviation|Mean
87285|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.||events per subject-year||Standard Error|Mean
87286|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.||events per subject-year||Standard Error|Mean
87287|NCT00935532|Secondary|Change in Blood Pressure From Baseline to Endpoint (Week 26)|Change in Blood Pressure from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mmHg||Standard Deviation|Mean
87288|NCT00935532|Secondary|Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline|Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
87289|NCT00935532|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)|Change in HDL-C from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mg/dL||Standard Error|Least Squares Mean
87290|NCT00935532|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26)|Change in Total Cholesterol from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mg/dL||Standard Error|Least Squares Mean
87291|NCT00935532|Secondary|Change in Body Weight From Baseline to Endpoint (Week 26)|Change in Body Weight from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||kg||Standard Error|Least Squares Mean
87292|NCT00935532|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)|Change in FSG (centralized measurement) from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.||mg/dL||Standard Error|Least Squares Mean
87293|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=6.5%|Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.||percentage of subjects|||Number
87294|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=7%|Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.||percentage of subjects|||Number
87295|NCT00935532|Primary|Change in HbA1c From Baseline to Endpoint (Week 26)|Change in HbA1c from baseline to endpoint (Week 26).|Baseline, Week 26|Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||percentage of total hemoglobin||Standard Error|Least Squares Mean
87297|NCT00935493|Secondary|Alzheimer’s Disease Cooperative Study—Clinical Global Impression of Change (ADCS-CGIC)|The seven-point scale was collapsed into 3 groups and coded as a three-level ordinal scale of global status, representing ordered levels of worse (including minimally, moderately and markedly worse), unchanged, and improved (including minimally, moderately, and markedly improved) global status.|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow-up||participants|||Number
87298|NCT00935493|Primary|Mean in the Prefrontal Executive Function Z-score (PEF6_6)|"The primary outcome measure (PEF6_Z) is the mean of z-scores for 6 executive function tasks (CANTAB: Spatial Working Memory, Stockings of Cambridge, Intradimensiona/Extradimensional Shift, Paired Associates Learning; Stroop Color Word Score, Trail Making Test – B).~The score is composed of six component scales coded as z scores that measures cognitive functioning in which higher scores represent better cognitive functioning; therefore, the least squares means listed here represent mean outcome changes from baseline"|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks follow-up.||Z-score||Standard Error|Least Squares Mean
87299|NCT00935311|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug.||participants|||Number
87300|NCT00935311|Secondary|Time to First Rescue Medication|The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||minutes||95% Confidence Interval|Median
87301|NCT00935311|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
87302|NCT00935311|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.||scores on a scale||Standard Error|Least Squares Mean
87303|NCT00935272|Secondary|Percentage of Participants With a Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at weeks 12, 16, 20 and 24|For this secondary objective, the pool of participants analyzed was based on 135 from the Intent to Treat population. However the analysis was done with the number of subjects with non-missing data. This number varied for each timepoint.||Percent of responders||95% Confidence Interval|Number
87304|NCT00935272|Primary|Percentage of Participants With Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at 8 weeks|Analysis was ITT; Sample size based upon a one-sided Fisher's Exact test with alpha = 0.05; Subjects with a missing Blinded Evaluator assessment as Week 8 were imputed using the hot deck method||Percentage of Participants||95% Confidence Interval|Number
87305|NCT00935259|Secondary|Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo|Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.|2 weeks|Only participants with complete fasting delta 5 desaturase enzyme activity data were included.||ratio||Standard Deviation|Mean
87306|NCT00935259|Secondary|Blood Linoleic Acid Levels|Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.|2 weeks|Only participants with complete blood linoleic acid data were included.||nmol||Standard Deviation|Mean
87307|NCT00935259|Secondary|Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level|"Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio [dose = 162 g/m^2]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.~The mean reported was an adjusted mean (defined in first outcome measure)."|2 weeks|Only participants with complete PCSK9 data were included.||nmol||Standard Deviation|Mean
87331|NCT00934843|Secondary|Total Intake/Output of Fluid|Total amount of all fluids in and out during the first 36 hours postoperatively in mL.|over 36 hours|||mL||Standard Deviation|Mean
87309|NCT00935259|Primary|Arachidonic Acid Level After 2 Weeks of Treatment|"Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.~The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term."|2 weeks|Only participants with complete arachidonic acid data were included.||nmol||Standard Deviation|Mean
87310|NCT00935220|Secondary|DPP-4 Inhibition: E_24|Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration|Treated set||Percent (of inhibition)||Full Range|Median
87311|NCT00935220|Secondary|Linagliptin: C_max|maximum concentration of linagliptin in plasma on Day 1|24h|Treated set - All patients with values for the maximum measured concentration of linagliptin in plasma (C_max)||nmol/L||Geometric Coefficient of Variation|Geometric Mean
87312|NCT00935220|Primary|DPP-4 Inhibition: E_24,ss|Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration under steady state conditions|Treated set||Percent (of inhibition)||Full Range|Median
87313|NCT00935220|Secondary|Linagliptin: AUC_0-24|area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose|24 hours|Treated set- All patients with values for the area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose (AUC_0-24) for Linagliptin||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
87314|NCT00935220|Secondary|Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event|Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event|21 days|All treated patients||Participants|||Number
87315|NCT00935220|Primary|Linagliptin: C_max,ss|maximum concentration of linagliptin in plasma at steady state|24 hours|Treated set||nmol/L||Geometric Coefficient of Variation|Geometric Mean
87316|NCT00935220|Primary|Linagliptin: AUC_τ,ss|area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval|24 hours|Treated set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
87317|NCT00935220|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|21 days|All treated patients||Participants|||Number
87318|NCT00935220|Secondary|Treatment Emergent Adverse Events|Frequency of patients with AEs|21 days|All treated patients||Participants|||Number
87319|NCT00935064|Primary|Expiration/Inspiration Ratio Before and After Treatment|Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles.|baseline and 6 weeks|||Ratio||Standard Deviation|Mean
87320|NCT00935064|Primary|Mean Circular Resultant Before and After Treatment|Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable.|baseline and 6 weeks|||MCR is unitless||Standard Deviation|Mean
87321|NCT00935064|Primary|Serum Renin Level Before and After Treatment|Serum renin level at baseline and follow-up|baseline and 6 weeks|||ug/l/h||Standard Deviation|Mean
87322|NCT00935064|Primary|Diastolic Blood Pressure Before and After Treatment|Diastolic blood pressure at baseline and follow-up.|baseline and 6 weeks|||mm Hg||Standard Deviation|Mean
87323|NCT00935064|Primary|Systolic Blood Pressure Before and After Treatment|Systolic blood pressure at baseline and follow-up|baseline and 6 weeks|||mm Hg||Standard Deviation|Mean
87324|NCT00934947|Secondary|Anxiety Symptoms||Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6||||||
87325|NCT00934947|Secondary|Itch Symptoms||Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6||||||
87326|NCT00934947|Secondary|Sleep Quality||Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6||||||
87327|NCT00934947|Primary|Overall Pain Trajectory Slopes|Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.|Study days 5, 7, 10, 13, 17 and 19|||Numeric Rating Scale Score Change/Day||95% Confidence Interval|Least Squares Mean
87328|NCT00934921|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
87329|NCT00934921|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
87330|NCT00934921|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
87334|NCT00934843|Secondary|Inotropic Score|The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score.|over the first 36 hours after surgery|||Scores on a scale||Standard Deviation|Mean
87335|NCT00934843|Primary|Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.|The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support.|36 hours|||participants|||Number
87336|NCT00934791|Primary|Liver Volume at 2 Years After Kidney Transplantation|Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).|2 years|This study was terminated due to inadequate enrollment, no data was collected on the participant.|||||
87337|NCT00934648|Secondary|Percentage of Participants With Changes in Bone Density|Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.|Screening, Weeks 48 and 104|ITT population||percentage of participants|||Number
87338|NCT00934648|Secondary|Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Screening, Day 1, and Weeks 24 and 104|ITT population||percentage of participants|||Number
87339|NCT00934648|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Day 1 and Week 24|ITT population||scores on a scale||Standard Deviation|Mean
87340|NCT00934648|Primary|Percentage of Participants With an Adverse Event (AE)||Week 104|Safety population: included all participants who have received any part of an infusion of the study medication.||percentage of participants|||Number
87341|NCT00934635|Secondary|Assessment of the Ratio of Dopamine D2-receptor Occupancies in Two Different Areas of the Brain|No measures available due to early termination of trial|Analysis of PET scans at Visit 3 (day 3)||||||
87342|NCT00934635|Secondary|Plasma Concentrations of Paliperidone and Risperidone|No measures available due to early termination of trial|Measurement of plasma concentration at Visit 3 (day 3)||||||
87343|NCT00934635|Primary|Percentage of Paliperidone or Risperidone Dopamine D2 Receptor Occupancies||Visit 3 (on day 3)|PET imaging data were not submitted for further analysis. D2-receptor occupancies could not be calculated due to the low number of subjects in the healthy control group.||percentage|||Number
87344|NCT00934622|Secondary|Spectacle Independence|Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.|pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery|Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.||Percentage of Participants|||Number
87345|NCT00934622|Primary|Visual Acuity|Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery|||logMAR||Standard Deviation|Mean
87346|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|6-10 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.||participants|||Number
87347|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|3-6 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.||participants|||Number
87348|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|0-3 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.||participants|||Number
87349|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|During 10 minutes after cardiopulmonary bypass|||Air Microemboli||Standard Deviation|Mean
87350|NCT00934596|Secondary|pH at 45 Min of CPB|pH measured by arterial bloodgas at 45 minutes of CPB, comparison between groups|Intraoperative|||units on a scale||Inter-Quartile Range|Median
87351|NCT00934596|Post-Hoc|Fraction of Morphologically Damaged Red Blood Cells as Assessed by Scanning Electron Microscopy Studies.|Pieces of tubing from the cardiopulmonary circuit were prepared and photographed in a Scanning Electron Microscope. Visual inspection of each photograph by an investigator blinded to which group the photograph belonged to was performed. The proportion of damaged red blood cells over the total number of red blood cells were calculated.|Pieces of tubing collected after weaning from cardiopulmonary bypass|Samples were collected from 5 participants in each Group (total of 10 participants). For each participant 4 pieces of tubing were collected (20 pieces in each Group, total 40 pieces). Samples were photographed. One photograph from each individual was randomly selected and studied by an investigator blinded to Group (total of 10 photographs).||Fraction of Damaged Red Blood Cells||95% Confidence Interval|Mean
87352|NCT00934596|Secondary|Oxygenator Gas Flow at 45 Minutes of CPB|The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.|Intraoperative|||L/minute||Inter-Quartile Range|Median
87353|NCT00934596|Secondary|De-airing Time After Cardiac Ejection|The duration in minutes of the period after cardiac ejection to finished de-airing procedure.|During de-airing procedure|||minutes||Inter-Quartile Range|Median
87354|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|After cardiac ejection|||Air Microemboli||Standard Deviation|Mean
87355|NCT00934596|Secondary|De-airing Time Before Cardiac Ejection|Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).|Measured during intraoperative course|||minutes||Inter-Quartile Range|Median
87356|NCT00934596|Secondary|Total Time Required for De-airing|The total de-airing time as measured in minutes.|After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes|||Minutes||Inter-Quartile Range|Median
87357|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|Before cardiac ejection|||Air Microemboli||Standard Deviation|Mean
87358|NCT00934544|Secondary|Percentage of Participants With Bone Marrow Histomorphology at Week 48|This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used.|48 weeks|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria.||Percentage of participants|||Number
87359|NCT00934544|Secondary|Overall Survival (OS) by Treatment|Defined as the interval between randomization and death from any cause. Hazard ratios of OS and the corresponding 95% CIs were estimated using the Cox proportional hazards model stratified by baseline prognostic category. For the comparison of OS between INC424 (INCB018424) and BAT, a stratified 2-sided log-rank test was used. Sensitivity analysis was also conducted for OS with the data being censored at the end of the Randomized Phase for those subjects who entered the Extension Phase. Unstratified analyses were also performed by reporting hazard ratios with 95% CIs.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary end)||03/2016||||
87360|NCT00934544|Secondary|Leukemia-free Survival (LFS)|Defined as the interval between randomization and the date of the bone marrow blast count of 20% or greater OR the date of the first peripheral blast count of 20% or greater that was subsequently confirmed to have been sustained for at least 8 weeks OR the date of death from any cause, whichever occurs first.LFS was summarized using Kaplan-Meier estimates for each treatment arm. The estimates were supplemented by tables of number of events and probability estimates at several timepoints.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary end)||03/2016||||
87361|NCT00934544|Secondary|Progression Free Survival (PFS) by Treatment|Defined as the time from the date of randomization/start of treatment to the date of the first documented disease progression including death due to any cause.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary endpoint)||03/2016||||
87362|NCT00934544|Secondary|Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment|﻿This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume.|Baseline, every 12 weeks until first 35% reduction in spleen is achieved|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.||Proportion of participants||95% Confidence Interval|Median
87530|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|24 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab||percentage of participants|||Number
87363|NCT00934544|Secondary|Duration of Maintenance of at Least 35% Reduction in Spleen Volume (DoMSR) From Baseline|DoMSR is defined as the interval between the first spleen volume measurement that is >=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a >25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.|Baseline, every 12 weeks until 25% progression from baseline|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.||Proportion of participants||95% Confidence Interval|Median
87364|NCT00934544|Secondary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24|The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.|Baseline, Week 24|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT)prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.||Percentage of Participants|||Number
87365|NCT00934544|Primary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48|The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group.|Baseline, Week 48|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.||Percentage of Participants|||Number
87366|NCT00934375|Primary|Number of Participants With Treatment-Emergent Adverse Events|Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)|Baseline, Week 6, Week 12 and Week 28.|||Participants|||Number
87367|NCT00934362|Secondary|Spirometry|Percent change (relative) in FEV1 between pre-treatment baseline and following 5 doses of study treatment. Post treatment values obtained 3 and approximately 22 hours after 5th dose were averaged to determine the treatment effect.|after 5 doses|per protocol||percent change||Standard Deviation|Mean
87368|NCT00934362|Primary|Change in Mucociliary Clearance|Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. <60 minutes after the last dose of lucinactant or placebo) reported.|1 hour after final treatment (5th dose) minus baseline|Per protocol||percent clearance||Standard Deviation|Mean
87369|NCT00934180|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
87370|NCT00934180|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
87371|NCT00934180|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
87372|NCT00934141|Secondary|Cost of Group|"The goal of the economic analysis was to estimate costs of each group for governmental authorities who might organize improvement collaboratives. We collected the cost of personnel (state employees, NIATx employees, coaches and consultants), data management, buildings and facilities, lodging, travel, telephone calls and miscellaneous costs. Costs were categorized as group specific (such as hotel costs for the learning sessions group) or non-group-specific, which included state-incurred costs for outreach, data management and infrastructure, encouraging participation and administration. Cost data were collected three times during the study period and aggregated to create a total cost estimate. Figures reported below represent costs at the arm/group level (costs were not assessed at the organizational level). Measure type is Number."|Baseline and 18 months|||USD ($)|||Number
87373|NCT00934141|Primary|Change in Average Continuation Rate Through the Fourth Treatment Session|"This outcome represents change in the rate at which a clinic's patients continue in treatment. Continuation rate is defined as the percentage of patients that make at least 4 visits to the clinic, on different days, before being discharged. Estimates of improvement show the average percentage points of improvement per month based on a best linear unbiased predictor estimate for each site.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 21 months|||Change in continuation rate||Standard Error|Mean
87374|NCT00934141|Primary|Change in Annual Number of Patient Admissions|"We aimed to increase clinics' treatment capacity in this quality improvement study. Capacity was measured by counting clinics' annual number of patient admissions. We monitored changes in admission counts, per clinic, in a pre-post analysis. Changes in the natural logarithm of annual admissions are presented, which approximates the average percentage change (year-to-year) in the number of new patient admissions per clinic.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|48 months (2 year baseline period and 2 year post-intervention period)|||Percent change (approx.)||95% Confidence Interval|Mean
87375|NCT00934141|Primary|Change in Average Waiting Time From First Contact to Treatment|"The average length of time in days it takes from when a patient first calls for help to the time a patient was able to meet a clinician. In this quality improvement study, changes in this measure over time are reported. Estimates of improvement show the average days of improvement per month based on a best linear unbiased predictor estimate for each site.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 15 months|||Change in days||Standard Error|Mean
87376|NCT00934128|Primary|Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale|Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.|Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)|One participant assigned to receive BiPAP was mistakenly started on Vapotherm (High Flow Oxygen = HFO), and was reported here in the HFO group.||units on a scale||Inter-Quartile Range|Median
87377|NCT00934128|Primary|Number of Participants Completing Study Intervention|"Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study.~A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was >/= baseline dyspnea level-1, or (2) their dyspnea level was >/= 3/10 after one hour."|Minimally 1 hour, up to 5 hours|||Participants|||Number
87378|NCT00934102|Primary|Front Surface Lens Deposits|Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.|Period 2, Day 6|Per Protocol. Only the data from participants who completed all study visits were analyzed.||Units on a Scale|Participants|Standard Deviation|Mean
87379|NCT00934050|Primary|Treatment Emergent Adverse Events (TEAEs)|Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)|12 months|As a result of safety findings, effective 15 December 2009, all 50 patients at the 2000 mg BID dose were withdrawn from the study. Subsequently patients who were on placebo or 250 mg BID in Study AD201 received 250 mg BID in Study AD251. Only Arms who completed the study per the protocol were included in the analysis.||participants|||Number
87380|NCT00933933|Secondary|Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations|Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot.||Blood specimens|||Number
87381|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area.||Blood specimens|||Number
87382|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females.||Blood specimens|||Number
87383|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens|Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.|3 months|Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing.||Blood specimens|||Number
87384|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis.||Blood Specimens|||Number
87421|NCT00933335|Secondary|Time to Death of Participants During Their Participation in the Study|Time to death is defined as the time from the treatment start date to the date of death.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population||months||95% Confidence Interval|Median
87422|NCT00933335|Secondary|Number of Participants Who Died During Their Participation in the Study|Participants who died during the study period were evaluated for the overall survival endpoint.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population||participants|||Number
87564|NCT00932659|Primary|Number of Participants With a Significant Arrhythmia Detected||6 months|All patients enrolled were analyzed in this observational study.||participants|||Number
87385|NCT00933686|Secondary|Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale|Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Percentage of participants|||Number
87386|NCT00933686|Secondary|Multidimensional Assessment of Fatigue (MAF) Total Score|Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Units on a scale|||Number
87387|NCT00933686|Secondary|EuroQol 5-Dimensions (EQ-5D) Total Score|EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Units on a scale||Standard Deviation|Mean
87388|NCT00933686|Secondary|Visual Analog Scale (VAS) Total Score|Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||mm||Standard Deviation|Mean
87389|NCT00933686|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score|Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful).|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.||Units on a scale||Standard Deviation|Mean
87390|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 12|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.||Percentage of participants|||Number
87391|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 6|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 6|Intention-to-treat (ITT) population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.||Percentage of participants|||Number
87392|NCT00933608|Primary|N-acetylaspartate|The change in N-acetylaspartate (NAA) measured with magnetic resonance spectroscopy (MRS) is the primary outcome measure. NAA is a metabolite found predominately in neuronal cells, and its amount indicates tissue well being (the higher the better). In MRS studies NAA (and other metabolites like choline or myoinositol) are presented as a ratio to creatine (Cr) also measured by MRS. The concentration of creatine does not change is used as an internal standard. The ratio NAA/Cr is unitless. In summary, the measurable outcome will be the NAA/Cr ratio change from pre-to post treatment.|baseline (pre-treatment) and 4 months (post-treatment)|This is an intention to treat analysis, based on initial treatment assignment.||NAA/creatine Ratio||Standard Deviation|Mean
87393|NCT00933543|Secondary|Proportion of Patients With Dryness (Mild)||at 12 weeks after first treatment|Safety||participants|||Number
87394|NCT00933543|Secondary|Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)||at 12 weeks after first treatment|Safety||participants|||Number
87395|NCT00933543|Secondary|Proportion of Patients With Severe and Very Severe Scarring at End of Study||week 12|||participants|||Number
87396|NCT00933543|Secondary|Proportion of Patients With Clear or Almost Clear Scarring at End of Study||week 12|||participants|||Number
87397|NCT00933543|Secondary|Proportion of Patients With Mild or Moderate Scarring at End of Study||week 12|||participants|||Number
87398|NCT00933543|Secondary|Proportion of Patients With Severe Hyperpigmentation||at 12 weeks after first treatment|Safety||participants|||Number
87399|NCT00933543|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation||at 12 weeks after first treatment|Safety||participants|||Number
87400|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after fourth treatment|Safety population||cm||Full Range|Mean
88728|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||mmHg||Standard Deviation|Mean
87423|NCT00933335|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the treatment start date to the first occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with treatment failure were evaluated.||months||95% Confidence Interval|Median
87424|NCT00933335|Secondary|Number of Participants With a Treatment Failure|Treatment failure is defined as the occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87425|NCT00933335|Secondary|Time to Disease Progression or Death|Time to progression is the time from the treatment start date to the first documented disease progression or death. Disease progression: 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with disease progression were evaluated.||months||95% Confidence Interval|Median
87426|NCT00933335|Secondary|Number of Participants With Progressive Disease (PD)|PD is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87427|NCT00933335|Secondary|Duration of Response for All Confirmed Responders|Duration of response was defined as the time from the first documented response to the first documented disease progression. Partial Response (PR): 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions. Responders are the participants with CR, or CCR, or PR.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and were classified as responders were evaluated.||months||95% Confidence Interval|Median
87428|NCT00933335|Secondary|Number of Participants With Progression of Disease|Progression of disease is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination. All participants without progression of disease were censored.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: participants with confirmed response rates (CR, CCR, or PR) were evaluated.||participants|||Number
87429|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Unconfirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants (par.) evaluable for response were those with >= 1 response assessment. 2 of 38 par. who received <3 cycles of fludarabine withdrew from the study and were not evaluable for response. 35 of 38 par. received TST and I 131 TST treatment and were evaluated for response.||participants|||Number
87430|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Confirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions. A confirmed response (resp.) (CR/CCR/PR) had to be confirmed by a consecutive resp. (>=28 days later) that was the same/better. Individual confirmed resp. data only counts that resp. confirmed by the same resp.; not all possible combinations are represented.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. 2 participants (par.) who received <3 cycles of fludarabine (fl.) did not receive TST treatment and were not evaluated. Par. evaluable for response were those with >=1 assessment. Three par. were not evaluable for response. None of the responses could be confirmed after fl. treatment; thus, no data are reported for this arm.||participants|||Number
87431|NCT00933335|Primary|Number of Participants Receiving the Indicated Type of Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease. Supportive care involved administration of granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), red blood cell (RBC) transfusions, erythropoietin, and platelet transfusions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment and were not evaluated.||participants|||Number
87432|NCT00933335|Primary|Number of Participants Who Received Any Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment, and hence were not evaluated.||participants|||Number
87433|NCT00933335|Primary|Number of Participants With an Anti-infective Administered at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.||participants|||Number
87434|NCT00933335|Primary|Number of Participants With Positive Culture Results for Infections at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|The culture results could be positive or negative. The positive culture results indicates that the tested participant have the infection under investigation so therapeutic treatment with anti-infective is required.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses, those who had an infection, and from whom the cultures were obtained were evaluated.||participants|||Number
87435|NCT00933335|Primary|Number of Participants With a Culture Obtained for Infection at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.||participants|||Number
87436|NCT00933335|Primary|Number of the Indicated Type of Infection Reported by Investigator Based on Laboratory Testing at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated. A single participant could have had more than one infection. The number analyzed in the category titles reflects the number of participants who had any infection.||number of infections|||Number
87437|NCT00933335|Primary|Number of Participants With Any Infection at Week 16 Post-Fludarabine Treatment and Week 13 Post-TST Treatment Detected by Laboratory Culture of Participant Sample or Investigator Report|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||participants|||Number
87438|NCT00933335|Primary|Duration of Any Grade 3 or Grade 4 Toxicity for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||days||Full Range|Median
87439|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Toxicity (AE) for Hematological Parameters (Absolute Neutrophil Count [ANC], Hemoglobin, and Platelets)|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||participants|||Number
87440|NCT00933335|Primary|Nadir Values for Platelet Count|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.||10^3/microliter||Full Range|Median
87441|NCT00933335|Primary|Nadir Values for Hemoglobin|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.||g/dL||Full Range|Median
87442|NCT00933335|Primary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.||10^3/mm^3||Full Range|Median
88729|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||Kg/m2||Standard Deviation|Mean
87443|NCT00933335|Primary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: all participants who received the dosimetric dose were evaluated.||days||Full Range|Median
87444|NCT00933335|Primary|Number of Participants With Thyroid Medication Use Prior to the Therapeutic Dose|Thyroid medication included any prescribed medication for the treatment of thyroid dysfunction.|Baseline (study entry; Week -16) and Week 2 to Week 3 (prior to the therapeutic dose)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.||participants|||Number
87445|NCT00933335|Primary|Number of Participants With Elevated Thyroid-Stimulating Hormone (TSH) Levels at Baseline (Study Entry) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|The number of participants with elevated TSH levels is reported. An elevated TSH level indicates that an insufficient amount of the thyroid hormone is being produced. Insufficient thyroid hormone production is known as hypothyroidism. The normal range of TSH is between 0.2 and 6.1 milliunits per liter (mU/L).|Baseline (Week -16) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|ITT-Exposed Population: baseline TSH levels were determined for 36 participants. Of 35 participants who received the dosimetric and therapeutic doses of TST/I-131 TST, 2 had elevated TSH at baseline, and 33 were assessed for developing elevated TSH.||participants|||Number
87446|NCT00933335|Primary|Time to HAMA Positivity From the First TST/I 131 TST Dosimetric Dose for the Participants Achieving HAMA Positivity|Kaplan-Meier estimates of the time to HAMA positivity (days from the first fludarabine dose) was determined for participants who converted to HAMA positivity.|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who received dosimetric and therapeutic doses and those who were converted to HAMA positivity were evaluated.||days|||Number
87447|NCT00933335|Primary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Weeks 12 and 25 and at Months 12, 18, and 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit (Weeks 12 and 25; Months 12, 18, and 24)."|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who were evaluable for HAMA (those who did not have a positive HAHA level at Baseline) and those who received dosimetric and therapeutic doses were evaluated.||participants|||Number
87448|NCT00933335|Primary|Number of Participants With the Indicated Treatment-related AEs Experienced by at Least 10% of Participants in the Combined Regimen|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87449|NCT00933335|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 AEs|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. mm, millimeters; mm^3, millimeters cubed. Grade 3 and Grade 4 AEs are reported to focus on the most severe AEs.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87450|NCT00933335|Primary|Number of Participants With Any Treatment-related SAE|All of the treatment-related SAEs experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87451|NCT00933335|Primary|Number of Participants With Any Serious Adverse Event (SAE)|An SAE was defined as any event occurring at any dose that results in any of the following outcomes: death, a life threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87452|NCT00933335|Primary|Number of Participants With Any Treatment-related Grade 3 or Grade 4 Adverse Event|All of the treatment-related grade 3 (severe and undesirable) and grade 4 (life-threatening or disabling) adverse events experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87453|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Adverse Event|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87565|NCT00932646|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|||participants|||Number
87454|NCT00933335|Primary|Number of Participants With Any Treatment-related Adverse Event (TRAE)|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population||participants|||Number
87455|NCT00933335|Primary|Number of Participants With Any Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a causal relationship (association) with this treatment. Therefore, an AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not it was considered to be related to the medicinal product. Laboratory abnormalities were recorded as AEs only if they were associated with clinical sequelae and/or required an intervention.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|Intent-to-Treat (ITT)-Exposed Population: all participants who were enrolled into the study and who received at least 1 dose of fludarabine. The data are presented for the subgroup of the ITT-Exposed Population for those participants who received the dosimetric and therapeutic dose of TST/I 131 TST.||participants|||Number
87456|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
87457|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
87458|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
87459|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
87460|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
87461|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
87462|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
87463|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
87464|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||seconds||Standard Deviation|Mean
88730|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||Kg/m2||Standard Deviation|Mean
87465|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
87466|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
87467|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.||meters||Standard Deviation|Mean
87468|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
87469|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
87470|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
87471|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|1 month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.||percentage of limbs|||Number
87472|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
87473|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
87474|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
87487|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87475|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|1 Month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed||percentage of limbs|||Number
87476|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|Baseline|Per ITT Set. Patients are included in the Rutherford Becker Score if the Rutherford Becker Classification was performed prior to the Study procedure.||percentage of limbs|||Number
87477|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87478|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87479|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87480|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87481|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87482|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87483|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87484|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87485|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87486|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87488|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87489|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87490|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87491|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87492|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87493|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87494|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87495|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87496|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87497|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87498|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|12 Months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit"||units on a scale||Standard Deviation|Mean
87509|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|30 days (±7 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
87499|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|6 Months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit."||units on a scale||Standard Deviation|Mean
87500|NCT00933270|Secondary|Quality of Life Assessed (QoL) by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the SF-12 Questionnaire prior to the study procedure"||units on a scale||Standard Deviation|Mean
87501|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|36 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87502|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|24 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87503|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|12 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87504|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|6 months (±14 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87505|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|36 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
87506|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|24 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
87507|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|12 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
87508|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|6 Months (±14 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.||percentage of participants|||Number
88731|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||Kg/m2||Standard Deviation|Mean
87510|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|36 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
87511|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|24 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
87512|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|12 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
87513|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|1 month (± 7 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."||percentage of limbs|||Number
87514|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.|36 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87515|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.|24 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87516|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.|12 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87517|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.|6 months (± 14 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87529|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|36 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab||percentage of participants|||Number
87518|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 Months (±30 days)|Per ITT set. Patients are included if they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab||percentage of participants||95% Confidence Interval|Number
87519|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab||percentage of participants||95% Confidence Interval|Number
87520|NCT00933270|Secondary|SFA Patency: PSV Ratio ≥ 2.0|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab||percentage of participants||95% Confidence Interval|Number
87521|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|36 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87522|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|24 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87523|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87524|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87525|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|12 Months (± 30 Days)|Per ITT set: Patient returned for visit and had ABI measured||ratio||Standard Deviation|Mean
87526|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|6 Months (± 14 Days)|Per ITT set: Patient returned for visit and had ABI measured||ratio||Standard Deviation|Mean
87527|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|1 month (± 7 Days)|Per ITT set: Patient returned for visit and had ABI measured||ratio||Standard Deviation|Mean
87528|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|Baseline|Per ITT set: Baseline ABI measured prior to study procedure||ratio||Standard Deviation|Mean
88732|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month|||Kg/m2||Standard Deviation|Median
87531|NCT00933270|Secondary|Stent Fracture Rate|"Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.~Stent fracture classification~Type I - a single strut fracture only.~Type II - multiple single nitinol stent fractures that can occur at different sites.~Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.~Type IV - a complete transverse linear type III fracture with stent displacement.~Type V - a spiral dissection of a stent."|12 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab||percentage of participants|||Number
87532|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||36 months (± 30 Days)|||percentage of participants||95% Confidence Interval|Number
87533|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||24 months (± 30 Days)|||percentage of participants||95% Confidence Interval|Number
87534|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||12 months (± 30 Days)|||percentage of participants||95% Confidence Interval|Number
87535|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 36 months (± 30 Days)(comparing pre- to post-procedural assessments).|36 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87536|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).|24 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87537|NCT00933270|Secondary|Secondary Safety Composite Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).|12 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87538|NCT00933270|Secondary|Device Success|Device success, defined as achievement of a final residual diameter stenosis of <50% (by QA), using the assigned treatment only.|intraoperative|Per ITT set: Supera implanted. Post-procedure angiogram analyzed by core lab||percentage of participants||95% Confidence Interval|Number
87539|NCT00933270|Secondary|Procedural Success|Defined as device success with < 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.|intraoperative|Per ITT set. Supera implanted. Post-procedure angiogram analyzed by core lab Occurrence of death, amputation or TLR during the hospital stay||percentage of participants||95% Confidence Interval|Number
87540|NCT00933270|Secondary|Technical (Lesion) Success|Technical (lesion) success, defined as the attainment of <50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.|intraoperative|Per ITT set: Post-procedure angiogram analyzed by core lab||percentage of treated segments||95% Confidence Interval|Number
87541|NCT00933270|Primary|Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR.|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 months|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87542|NCT00933270|Primary|Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.||30 days|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."||percentage of participants||95% Confidence Interval|Number
87543|NCT00933244|Other Pre-specified|Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test|We summarized within-arm one-year changes in continuous muscle outcomes using the mean (95% confidence interval).|1 Year|4% of subjects withdrew from the study and muscle tests were not conducted in four additional subjects who sustained injury or reported leg pain during a study visit. Thus the number analyzed is less than the number randomized into the trial.||seconds||95% Confidence Interval|Mean
87544|NCT00933244|Other Pre-specified|Bone Turnover|C-telopeptide (pg/mL) was measured at baseline, 30 days, 60 days, 120 days, 365 days in the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am. Data demonstrated outliers and was summarized using the median (25th, 75th interquartile range).|0, 30, 60, 120, 365 days|Bone turnover markers were analyzed in duplicate for the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am.||pg/mL||Inter-Quartile Range|Median
88733|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal|||pg/ml||Standard Deviation|Mean
87545|NCT00933244|Secondary|Bone Mineral Density|Annualized percent change in bone mineral density at spine, hip, femoral neck, and body|1 Year|Annual changes in bone mineral density were analyzed for subjects who completed the study. 9 subjects (4%) withdrew from the study, all for personal reasons. Thus, number of participants analyzed is 4% less than number of subjects randomized.||Percent Change in Bone Mineral Density||Inter-Quartile Range|Mean
87546|NCT00933244|Primary|Intestinal Calcium Absorption|Percent of calcium absorbed in the intestinal tract within one day|One Year|4% of subjects withdrew from the study. Additionally the calcium isotope dose was not recorded in 2 subjects and a urine sample was mishandled in a third. Thus, the number of participants analyzed is less than the number randomized into the trial.||Total Fractional Calcium Absorption||Inter-Quartile Range|Median
87547|NCT00933166|Primary|Comfort After Insertion|Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.||Units on a Scale||Standard Deviation|Mean
87548|NCT00932893|Secondary|European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
87549|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
87550|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.|Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
87551|NCT00932893|Secondary|Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough|TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.|Baseline up to end of treatment (up to 112 weeks)|Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment.||months||95% Confidence Interval|Median
87552|NCT00932893|Secondary|Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins|Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)|The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment).||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
87553|NCT00932893|Secondary|Number of Participants With Categorical Maximum QTcF for Crizotinib|QT interval corrected using Fridericia’s formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2|ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement.||participants|||Number
88734|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||Kg/m2||Standard Deviation|Mean
87554|NCT00932893|Secondary|Plasma Concentration of Crizotinib|Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5|"Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here N (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points."||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
87555|NCT00932893|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.||weeks||Full Range|Median
87556|NCT00932893|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.||weeks||95% Confidence Interval|Median
87557|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 12|Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Week 12|FAS included all participants who were randomized to study treatment.||percentage of participants||95% Confidence Interval|Number
87558|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 6|Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.|Week 6|FAS included all participants who were randomized to study treatment.||percentage of participants||95% Confidence Interval|Number
87559|NCT00932893|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment.||percentage of participants||95% Confidence Interval|Number
87560|NCT00932893|Secondary|Overall Survival Probability at Months 6 and 12|Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.|Month 6, 12|FAS included all participants who were randomized to study treatment.||percent chance of survival||95% Confidence Interval|Number
87561|NCT00932893|Secondary|Overall Survival (OS)|OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Randomization until death (up to 4.5 years)|FAS included all participants who were randomized to study treatment.||months||95% Confidence Interval|Median
87562|NCT00932893|Primary|Progression-Free Survival (PFS)|PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|Full analysis set (FAS) included all participants who were randomized to study treatment.||months||95% Confidence Interval|Median
87563|NCT00932659|Secondary|Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias||6 months|all participants included||participants|||Number
87566|NCT00932646|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS).||Liter||Standard Error|Least Squares Mean
87567|NCT00932646|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87568|NCT00932646|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87569|NCT00932646|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
87570|NCT00932646|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
87571|NCT00932646|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
87572|NCT00932646|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87573|NCT00932646|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87574|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
87575|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
87597|NCT00932451|Secondary|Disease Control Rate (DCR)|DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Percentage of participants||95% Confidence Interval|Number
87842|NCT00929708|Secondary|Total Score SGRQ-C (St George’s Respiratory Questionnaire for COPD)|The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)|At baseline (visit 2) and after 4 weeks of treatment (visit 5).|||Score||Standard Deviation|Mean
87576|NCT00932646|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) date and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.||Liter||Standard Error|Least Squares Mean
87577|NCT00932620|Secondary|Changes in Low-density Lipoprotein Cholesterol (LDL-C)||3 months|||LDL-C, mg/dL||Standard Deviation|Mean
87578|NCT00932620|Primary|Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels||Baseline and 3 months|||sdLDL-C, mg/dL||Standard Deviation|Mean
87579|NCT00932477|Secondary|The Number of Ophthalmic Adverse Events at 1 Week|The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Number of adverse events|||Number
87580|NCT00932477|Secondary|Best-Corrected Visual Acuity (BCVA) Status at 1 Week|"BCVA status at 1 week reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more in at least 1 eye; No Change equals change between -2 to +2 lines in either eye; Worse equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly."|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Number of Patients|||Number
87581|NCT00932477|Secondary|Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week|Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Number of Patients|||Number
87582|NCT00932477|Primary|Tolerability Questionnaire Mean Scores at 1 Week|Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.||Scores on a scale||Standard Deviation|Mean
87583|NCT00932451|Primary|Percentage of Participants With Adverse Events|Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).||Percentage of Participants|||Number
87584|NCT00932451|Primary|Objective Response Rate|The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Percentage of participants||95% Confidence Interval|Number
87585|NCT00932451|Secondary|Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale|The EQ-5D descriptive system measured a patient’s health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent’s self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
87586|NCT00932451|Secondary|Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)|"The participants who responded to the question: Have you experienced any visual disturbances? Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question."|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).||Percentage of participants|||Number
87587|NCT00932451|Secondary|Mean Change From Baseline of QLQ-LC13 Scale Scores|The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
87626|NCT00932152|Secondary|To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.||1.5 years||||||
87588|NCT00932451|Secondary|Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores|The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
87589|NCT00932451|Secondary|Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.|The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The patient reported outcomes (PRO) evaluable population was defined as the participants from the safety analysis (SA) population who completed a baseline assessment and at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
87590|NCT00932451|Secondary|QTc Prolongation in Participants|The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and ≥500 msec) were evaluated.|6 years|Participants from the SA population who had a Baseline (last ECG [electrocardiogram] prior to Cycle 1 Day 1 dose) and ≥1 post Baseline ECG measurement and were not included in the ECG sub-study.||Percentage of participants|||Number
87591|NCT00932451|Secondary|Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)|The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.|6 years|The All Genotyped Population was defined as all participants in the safety analysis population who had at least 1 genotype result. The Pharmacogenomic Evaluable (PE) Population was defined as participants in the All Genotyped Population who had an HLA genotype result and were designated as an ALT Case or Control.||Percentage of participants|||Number
87592|NCT00932451|Secondary|Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)|Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.|6 years|The safety analysis population included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing) and were ALK positive by IUO (SA-ALK positive by IUO population)||Percentage of cells||Full Range|Median
87593|NCT00932451|Secondary|Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182|Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.|6 years|All participants who have ≥ 1 measurement of PF-02341066 or PF-06260182 at the time of reporting are included in PK analysis. Concentration at Cycle 2 Day 1 and beyond are considered steady state, and only included those who received at least 14 continuous days of 250 mg BID dosing.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
87594|NCT00932451|Secondary|Probability of Survival|Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.||Percentage of probability||95% Confidence Interval|Number
87595|NCT00932451|Secondary|Overall Survival (OS)|OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death − date of Cycle 1 Day 1 dose + 1)/30.4.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.||Months||95% Confidence Interval|Median
87596|NCT00932451|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.||Months||95% Confidence Interval|Median
87598|NCT00932451|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Weeks||Full Range|Median
87599|NCT00932451|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death − first date of CR or PR that was subsequently confirmed + 1)/30.4.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.||Months||95% Confidence Interval|Median
87600|NCT00932425|Primary|Completion of Assigned Monitoring as a Measure of Feasibility|Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset.|21 days|Only patients in the monitoring arm were assessed for compliance with assigned monitoring||participants|||Number
87601|NCT00932425|Secondary|Recurrent Stroke or TIA|Patients and their primary physicians or neurologists were contacted at 3 months and 1 year after discharge and reported clinical diagnoses of recurrent stroke or TIA using validated questionnaires. Reported events were verified by review of relevant medical records.|1 year|||participants|||Number
87602|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||1 year|2 participants in the Control arm were followed for less than 90 days||participants|||Number
87603|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||90 days|2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow)||participants|||Number
87604|NCT00932425|Primary|Completion of Clinical Follow-up as a Measure of Feasibility|Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable|1 year|||participants|||Number
87605|NCT00932399|Primary|% Weight Change From Baseline|Time window for 3 years is 31-39 months after baseline|At ~3 years after baseline|||% weight change||95% Confidence Interval|Mean
87606|NCT00932373|Primary|PK Parameters After the First Dose: Terminal Half-life (t½) for T-DM1 Concentrations|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.||day||Standard Deviation|Mean
87607|NCT00932373|Primary|PK Parameters After the First Dose: Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-∞] for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.||day • μg/mL||Standard Deviation|Mean
87608|NCT00932373|Primary|Pharmacokinetic (PK) Parameters After the First Dose: Maximum Observed Plasma Concentration Cmax for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.||μg/mL||Standard Deviation|Mean
87609|NCT00932373|Primary|Maximum Tolerated Dose (MTD)|The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1||mg/kg|||Number
87610|NCT00932373|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|"DLT is defined as one of the following as per investigator related to study drug:~Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity~Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging~Grade ≥ 4 thrombocytopenia~Grade ≥ 4 neutropenia (absolute neutrophil count < 500/μ L) lasting > 4 days or accompanied by fever~Grade ≥ 4 anemia~Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT.~Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22"|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety Population included all treated patients||participants|||Number
87611|NCT00932373|Secondary|Percentage of Participants With Anti-therapeutic Antibodies to Trastuzumab Emtansine|After the start of trastuzumab emtansine treatment, serum samples were collected every 3 weeks prior to trastuzumab emtansine dosing for detection of anti-therapeutic antibodies using a validated assay. A bridging antibody electrochemiluminescence assay (ECLA) was used to detect antibodies to trastuzumab emtansine. The assay utilized trastuzumab emtansine conjugated to biotin and a ruthenium label to form a complex with anti-trastuzumab emtansine antibodies. The antibody complex was captured by streptavidin-coated paramagnetic beads.|Baseline to the end of the study (up to 3 years 2 months)|||percentage of participants|||Number
87627|NCT00932152|Secondary|To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.||1.5 years||||||
87628|NCT00932152|Secondary|To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities||1.5 years||||||
87629|NCT00932152|Primary|To Evaluate the Progression-free Survival.||1.5 years|Analysis was not completed because the trial was stopped prematurely due to slow accrual.|||||
87612|NCT00932373|Secondary|Progression-free Survival|Progression-free survival was defined as the time from first dose of trastuzumab emtansine to documented disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.||Months||95% Confidence Interval|Median
87613|NCT00932373|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.||Months||95% Confidence Interval|Median
87614|NCT00932373|Secondary|Percentage of Participants With an Objective Response|The occurrence of an objective response was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). An objective response was defined as a complete response or a partial response as determined on 2 consecutive occasions ≥ 4 weeks apart. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.||percentage of participants|||Number
87615|NCT00932373|Primary|Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment|"The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.~The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first."|Study treatment initiation until 30 or 90 days after last administration of study treatment|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1||percentage of participants|||Number
87616|NCT00932321|Secondary|Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population|Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.|5.6 months (6 - 28 day cycles)|Modified Intent to Treat (MITT)||Days||Standard Deviation|Mean
87617|NCT00932321|Primary|Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population|Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment|5.6 months (6 - 28 day cycles)|Modified intention to treat (MITT) subset of all treat subjects - evaluated for pregnancy at least once after beginning study medication.||Pearl Index|||Number
87618|NCT00932165|Primary|Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status||24 weeks|The participants who were evaluated for efficacy of Aromasin for the post-operative adjuvant therapy.||participants|||Number
87619|NCT00932165|Primary|Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment|Anti-tumor effect was evaluated according to the rules for ‘General Rules for Clinical and Pathological Recording of Breast Cancer’ (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start.|24 weeks|N = number of participants with tumor response||participants|||Number
87620|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction|The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.|24 weeks|Subjects with renal Dysfunction.||participants|||Number
87621|NCT00932165|Primary|Number of Participants With Adverse Drug Reaction|Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported.|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.||participants|||Number
87622|NCT00932165|Primary|Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Scale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, <50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, >50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)|24 weeks|||participants|||Number
87623|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction|The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information.|24 weeks|Subjects with hepatic Dysfunction.||participants|||Number
87624|NCT00932165|Primary|Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.||participants|||Number
87625|NCT00932165|Secondary|Number of Participants With Unexpected Adverse Drug Reaction|"Adverse drug reaction that is not included in the “precautions for use”or undesirable effects section in the package insert (same as Local Product Document)."|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.||participants|||Number
87631|NCT00932126|Secondary|PAK (p21 Activated Kinase)-Related Pathway Molecule Expression Modulation by PF-03758309 in Tumor and Surrogate Tissue||Screening, 0, 2, 4, and 72 hours post dose Cycle 2 Day 8. A 6th sample of hair follicle could be requested at 6 or 8 hours post-dose if necessary. For fresh tumor tissue, baseline and between Day 8 and 22 of Cycle 1 in participants with accessible tumors|Data not analyzed due to early study termination.|||||
87632|NCT00932126|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
87633|NCT00932126|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
87634|NCT00932126|Secondary|Area Under the Concentration-Time Curve From Time 0 to 12 Hours Post Morning Dose [AUC(0-12)]||pre-dose and 12 hours post morning dose|Data not analyzed due to early termination of the study.|||||
87635|NCT00932126|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
87636|NCT00932126|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
87637|NCT00932126|Secondary|Maximum Observed Plasma Concentration (Cmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.|||||
87638|NCT00932126|Secondary|Duration of Response|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.|||||
87639|NCT00932126|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.|||||
87640|NCT00932126|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Per protocol analysis set: all participants who have received a minimum of 1 cycle of study treatment (at least 80% of planned dose), had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response.||participants|||Number
87641|NCT00932126|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLT)|DLT includes: Grade (GR) 4 neutropenia (NP) that persisted for >7 consecutive days; Febrile NP; GR3 NP infection; GR4 thrombocytopenia (TP); GR3 TP with bleeding; Any other GR>=3 toxicity not classified under Common Terminology Criteria for Adverse Events (CTCAE) blood or bone marrow (exception of nausea, vomiting, or diarrhea in subjects who received optimal treatment with antiemetics or anti-diarrheals); Failure to recover to an adequate condition to recommence study treatment after a 2-week delay; Failure to receive >= 80% of planned PF-03758309 dose due to study drug related toxicity|Baseline (up to 30 days prior to first study drug administration) till 28 days after the last treatment administration (end of Cycle 1 [28 days])|Safety analysis set: All participants enrolled in the study that received at least 1 dose of PF-03758309 (including the lead in dose).||participants|||Number
87642|NCT00932022|Secondary|Percent Change From Baseline in Percentage of Patients Continent|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
87643|NCT00932022|Secondary|Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
87644|NCT00932022|Secondary|Percent Change From Baseline in Voided Volume|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
87645|NCT00932022|Secondary|Percent Change From Baseline in Urgency Severity Associated With Toilet Voids|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14||||||
87700|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load <=100,000 copies per mL||participants|||Number
87646|NCT00932022|Primary|Percent Change From Baseline in Urinary Urgency Incontinence (UUI)|Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.|Baseline (Week 2), Week 14|Modified Intent-to-Treat (mITT) defined as all patients who were randomized and received at least one dose of study medication. Analysis below was done on patients from the mITT population who completed the study at Week 14 and who had data available for this outcome measure.||Percent change||Standard Deviation|Mean
87647|NCT00931996|Primary|Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.|Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.|Baseline and 6 weeks|Completers||units on a scale||Standard Deviation|Mean
87648|NCT00931918|Secondary|Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher|Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.|Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)|Safety Population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
87649|NCT00931918|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category|Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)|Safety Population included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
87650|NCT00931918|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||months||95% Confidence Interval|Median
87651|NCT00931918|Secondary|Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate|FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.|End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
87652|NCT00931918|Secondary|Duration of Response|Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Participants from the Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment who had a CR or PR||months||95% Confidence Interval|Median
87653|NCT00931918|Secondary|Complete Response Rate|Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
88735|NCT00923195|Secondary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|32 months|||Participants|||Number
87654|NCT00931918|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.||percentage of participants||95% Confidence Interval|Number
87655|NCT00931918|Secondary|Overall Survival|Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||months||95% Confidence Interval|Median
87656|NCT00931918|Primary|Progression-Free Survival Rate|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.|2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||percentage of participants|||Number
87657|NCT00931918|Primary|Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.||months||95% Confidence Interval|Median
87658|NCT00931801|Secondary|Change in Quality of Life From Baseline to 48 Weeks of Study Treatment|Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.|baseline and 48 weeks|Data for all participants assigned to a study treatment was analyzed except data for participants that did not have both baseline and week 48 data, including early withdrawal, virologic failure, loss to follow-up or missing data.||units on a scale||Standard Deviation|Mean
87659|NCT00931801|Secondary|The Change in Adherence to Study Treatment Arm From Baseline to Week 48|Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or other error.||percentage of prescribed doses||Standard Deviation|Mean
87660|NCT00931801|Secondary|The Difference in CD4 From Baseline to Week 48|Change in mean CD4 from Baseline to Week 48.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or lab error.||cells/mm3||Standard Deviation|Mean
87661|NCT00931801|Primary|Maintenance of Virologic Suppression|To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.|48 weeks|All enrolled participants were included in this analysis of primary outcome measurement.||participants|||Number
87662|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 11|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 11 (insight) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87701|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL|The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load >100,000 copies per mL||participants|||Number
87663|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 10|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 10 (appearance) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87664|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 9|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. . This analysis is for Item 9 (disruptive-aggressive behavior) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87665|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 8|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 8 (content) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87666|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 7|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 7 (language-thought disorder) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87667|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 6|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 6 (speech-rate and amount) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87668|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 5|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 5 (Irritability) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87669|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 4|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|||Scores on a scale||Standard Error|Least Squares Mean
87670|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 3|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 3 (sexual interest) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87671|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 2|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 2 (increased motor activity-energy) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87672|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 1|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 1 (Elevated mood) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87673|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Positive Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87674|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Activation Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87675|NCT00931723|Secondary|Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210.A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87676|NCT00931723|Secondary|Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms.|Change from baseline to Day 43.|||Scores on a scale||Standard Error|Least Squares Mean
87677|NCT00931723|Secondary|Improvement of Overall Bipolar Illness|"The number of patients with a CGI-BP-C of “Much” or “Very much” improved in overall bipolar illness assessment at Day 43 was calculated.~The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement."|Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Participants|||Number
87678|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)|The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87679|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)|The CGI-BP-S scale rates the severity of the patient’s illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87680|NCT00931723|Secondary|Remission|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) from Days 8 to 43) was calculated.~The Young Mania Rating Scale total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|Days 8 to 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Participants|||Number
87681|NCT00931723|Secondary|The Number of Patients With Clinically Significant Response.|The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|43 days (from baseline to Day 43)|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Participants|||Number
87702|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure|"The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures:~i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy"|48 weeks|Non-completer classes as failure||participants|||Number
87682|NCT00931723|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Change in YMRS total score from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).||Scores on a scale||Standard Error|Least Squares Mean
87683|NCT00931710|Secondary|Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit|To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.|3, 6, 9 and 12 weeks|Full Analysis Set (FAS).||cumulative percentage of patients|||Number
87684|NCT00931710|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks|To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to week 12|Full Analysis Set (FAS). Last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
87685|NCT00931710|Secondary|Cumulative Percentage of Treatment Responders|To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).||Cumulative percentage of responders|||Number
87686|NCT00931710|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Control|To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).||cumulative percentage of patients|||Number
87687|NCT00931710|Secondary|Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
87688|NCT00931710|Primary|Change in Mean Sitting Systolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
87689|NCT00931632|Secondary|Days of Airway Pressure Support - Intent-to-treat Population|Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.|during birth hospitalization||||||
87690|NCT00931632|Primary|Survival Without BPD at 36 Weeks||Baseline, 36 weeks PMA|Subjects with missing primary outcome or who crossed over to open-label iNO during the blinded treatment period were considered as failures||participants|||Number
87691|NCT00931528|Secondary|Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
87692|NCT00931528|Secondary|Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
87693|NCT00931528|Secondary|Patient-related Predictors of EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
87694|NCT00931528|Secondary|Patient and Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
87695|NCT00931528|Secondary|Patient and Partner Overall Sexual Satisfaction as Measured by the Sexual Adjustment Questionnaire (SAQ) at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
87696|NCT00931528|Secondary|Overall Sexual Function as Measured by the IIEF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
87697|NCT00931528|Secondary|Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT||Baseline to 2 years from the start of radiation therapy||||||
87698|NCT00931528|Primary|Spontaneous (Off-drug) Erectile Function (EF) as Measured by International Index of Erectile Function (IIEF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)|The primary endpoint is maintenance of spontaneous (off-drug) erectile function at weeks 28-30 after initiation of RT, as measured by the IIEF Q1. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders. We hypothesize that the proportion of patients maintaining erectile function while receiving tadalafil (Arm 1) will be significantly higher than for patients receiving placebo treatment (Arm 2). Treatment differences will be tested at the 0.05 significance level using the Fisher exact test. Point estimates and 95% confidence intervals will also be provided.|Baseline to 30 weeks from the start of radiation therapy|All randomized eligible patients with IIEF at both baseline and 30 week time point.||percentage of participants||95% Confidence Interval|Number
87699|NCT00931515|Primary|Participants With Improved Patient Function|"The comparison of results was based on the proportion of participants with improved outcomes.~The primary efficacy variable was treatment success based on the following criteria:~Oswestry Disability Index score improved by at least 15 points~Device success~Neurological success~Absence of major complications~Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure."|24 months|||participants|||Number
87703|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Per protocol||participants|||Number
87705|NCT00931411|Secondary|Preferred Formulation|Number of participants that preferred one formulation over the other. All patients started the study with one cream and crossed over to the other cream at Day 42 for another 14 days. Participants were asked which they prefered.|56 days|All subjects with an evaluation after the Day 42 visit were included in this evaluation if their overall compliance was between 70 and 120%. Two patients lost to follow-up, one with no Day 56 value and 5 less than 70% compliant were not included in this analysis.||Participants|||Number
87706|NCT00931411|Secondary|Change in Mean Tolerance After Crossover|"Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study):~1) Very good tolerance: no objective or subjective intolerance during the study~2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign~3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign~4) Poor tolerance: symptoms requiring cessation of application, no objective sign~5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|14 Days (Day 42 to Day 56 of the study)|All subjects that had at least one evaluation after Day 7 (no day 0 visit for this parameter) were included in the analysis. Missing data were replaced using the last observation carried forward method. The same patients as in outcome #7 did not have results to carry forward and were not included in analysis (subjects swapped after crossover).||Units on a scale||Standard Deviation|Mean
87707|NCT00931411|Secondary|Change in Tolerance Before Crossover|"Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale:~1) Very good tolerance: no objective or subjective intolerance during the study~2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign~3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign~4) Poor tolerance: symptoms requiring cessation of application, no objective sign~5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|7, 42 days|All subjects that had at least one evaluation after the Day 7 (no Day 0 visit for this parameter) visit were included in the efficacy evaluations. Missing data were replaced using the last observation carried forward (LOCF) method. Four patients had no Day 7 visit to carry forward and were not included in this analysis.||Units on a scale||Standard Deviation|Mean
87708|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability After Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the 2 week period after the crossover. Scale from 44 (worst) to -44 (best). The 14 Days after the crossover is the same as Day 56 in the study.|14 days (Day 42 to Day 56 of the study)|Subjects that had at least one evaluation after the Day 0 visit were in analysis if they had overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward. Two patients lost to follow-up, 1 early term and 5 less than 70% compliant were not included in this analysis and participants swapped after crossover.||Units on a scale||Standard Deviation|Mean
87709|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability Before Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the first 42 prior to the crossover. Scale from 44 (worst) to -44 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in the cosmetic evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
87710|NCT00931411|Secondary|Change in Mean Quality of Life|The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worst) to 46 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in this evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
87711|NCT00931411|Secondary|Change in Mean Global Efficacy (by Parent)|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by parent).~0 = worsening~1 = No change~2 = Mild Improvement~3 = Moderate Improvement~4 = Good Improvement~5 = Excellent Improvement"|7, 42 days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, two missing Day 7 value and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
87712|NCT00931411|Secondary|Change in Mean Global Efficacy (by Investigator).|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by investigator).~0 = worsening~1 = No change~2 = Mild Improvement~3 = Moderate Improvement~4 = Good Improvement~5 = Excellent Improvement"|7, 42 Days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, one missing Day 7 value and 5 less than 70% compliant were not included in this analysis.||Units on a scale||Standard Deviation|Mean
87713|NCT00931411|Primary|Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0|The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.|7 , 42 days|All subjects that had at least one evaluation after the Day 0 visit were included in the efficacy evaluations if their overall compliance was between 70 and 120%. Missing data were replaced using the last observation carried forward (LOCF) method. Two patients lost to follow-up and 5 less than 70% compliant were not included in this analysis.||Percentage of change in SCORAD||Standard Deviation|Mean
88748|NCT00923117|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7/2/08 -12/6/13|||Participants|||Number
87714|NCT00931385|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.||participants|||Number
87715|NCT00931385|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87716|NCT00931385|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87717|NCT00931385|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
87718|NCT00931385|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
87719|NCT00931385|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
87720|NCT00931385|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87721|NCT00931385|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit. Peak (0-3h) values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS||Liter||Standard Error|Least Squares Mean
87722|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
87723|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS||Liter||Standard Error|Least Squares Mean
87724|NCT00931385|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS||Liter||Standard Error|Least Squares Mean
87785|NCT00930813|Primary|Angiographic Late Lumen Loss|Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.|6 months|Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.||mm||Standard Deviation|Mean
87725|NCT00931385|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) data and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.||Liter||Standard Error|Least Squares Mean
87726|NCT00931359|Secondary|Percentage of Subjects With Reported Adverse Events|Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.|6 months post-treatment|||Percentage of Participants|||Number
87727|NCT00931359|Secondary|Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit|"The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit."|12 months|Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.||Percentage of Participants|||Number
87728|NCT00931359|Secondary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities"|6 months post-treatment|||Percentage of Participants|||Number
87729|NCT00931359|Primary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities"|30 days post-treatment|Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.||Percentage of Participants|||Number
87730|NCT00931307|Primary|Comfort After Insertion|Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month’s wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||Scale of 1 to 10||Standard Deviation|Mean
87731|NCT00931268|Secondary|Time Until it Became Impossible to Stay Sitting|Evaluation of when (in minutes) it became impossible for the subject to stay in the sitting position on a standardized chair, at the time points 1, 3, 6, 9, 12 and 18 months compared to baseline. In this analysis “more than 60 minutes” was handled as 60 minutes.|Baseline and at 6 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.||minutes||Standard Deviation|Mean
87732|NCT00931268|Secondary|Adverse Event Recording|Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).|Up to 18 months after treatment|Reported AEs, Safety population||participants|||Number
87733|NCT00931268|Secondary|Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)|MRI was performed at baseline and at 1, 6, 9, and 12 months to determine the implant volume, thickness, localization and the possible local displacement of the implant. At the 6, 9 and 12 month visits any displacement was evaluated with MRI by comparison to the 1-month position of the gel. The number of participants with gel displacement are shown below.|12 months after treatment|||participants|||Number
87734|NCT00931268|Secondary|Number of Participants With Global Esthetic Improvement|Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos.|One month and up to 18 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.||participants|||Number
87735|NCT00931268|Secondary|Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire|A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline.|Baseline and at 6 months after treatment|The physical and mental health summary scores at 6 months after treatment were compared to baseline. The ITT population comprised 8 of 10 treated subjects.||units on a scale||Standard Deviation|Mean
87753|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Participant|Microbiological response was defined as reduction in bacterial load or eradication (measured as the percentage of participants with positive culture). Missing values were not imputed.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percentage of participants|||Number
87736|NCT00931268|Secondary|Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = “no pain” to the left and 100 = “worst possible pain” to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The change in VAS pain was assessed at the time points 1, 3, 9, 12 and 18 months compared to baseline.|Baseline and up to 18 months after treatment|The VAS pain at 1, 3, 9, 12 and 18 months after treatment was compared to baseline. Of 10 treated subjects the ITT populations at each time point was: 9 (1 month), 8 (3 months), 7 (9 months), 5 (12 months) and 4 (18 months).||mm||Standard Deviation|Mean
87737|NCT00931268|Primary|Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = “no pain” to the left and 100 = “worst possible pain” to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated.|6 months after treatment compared to baseline|All efficacy analyses were performed using the intention to treat (ITT) population. The ITT population at baseline and 6 months comprised all 10 treated subjects.||mm||Standard Deviation|Mean
87738|NCT00931242|Secondary|Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks|||participants|||Number
87739|NCT00931242|Secondary|Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks|||participants|||Number
87740|NCT00931242|Primary|Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points|Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12|12 weeks|||participants|||Number
87741|NCT00931164|Secondary|Neuropsychological Tests||Week 14||||||
87742|NCT00931164|Secondary|Functional Skills Questionnaires||Week 14||||||
87743|NCT00931164|Secondary|Mood and Behavior Questionnaires||Week 14||||||
87744|NCT00931164|Secondary|Quality of Life Questionnaires||Week 14||||||
87745|NCT00931164|Secondary|Mean Daily Percentage of Time That Functional Status is Affected Due to Episodes||Week 14||||||
87746|NCT00931164|Primary|Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase||1 year|||participants|||Number
87747|NCT00931164|Primary|Observed Safety Data During 5-day Hospitalization for Drug Dose Identification||Week 7||||||
87748|NCT00931164|Primary|Time Duration of AHC Episodes||Week 7||||||
87749|NCT00930982|Other Pre-specified|Change From Baseline in Total Bacterial Load in the Sputum|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL on Day 8. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. Decadic logarithm of colony forming units (CFUs) per gram sputum||log10 of CFU per gram sputum||Standard Deviation|Mean
87750|NCT00930982|Secondary|Emergence of Resistance Among Baseline Pathogens|The emergence of resistance (at least two-fold increase of Minimal inhibitory concentration, MIC, vs. baseline values) probably or possibly related to study medication among baseline pathogens was evaluated using microbiological analysis.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Participants|||Number
87751|NCT00930982|Secondary|Emergence of New Potential Respiratory Pathogens|The emergence of new potential respiratory pathogens was evaluated using microbiological analysis. Evaluated was the cumulative number of participants with first appearance of new potential respiratory antigens at each time point. In some cases, participants attended the end of study visit later than Day 84 (up to Day 88).|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Cumulative participants|||Number
87752|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Pathogen|Microbiological response was defined as reduction in bacterial load or eradication (measured as the number of participants with positive culture). Missing values were not imputed. Pathogens analyzed: Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Serratia marcescens, Pseudomonas aeruginosa, mucoid, Pseudomonas aeruginosa, non mucoid, Stenotrophomonas maltophilia, Achromobacter xylosoxydans, Moraxella catarrhalis, Haemophilus influenzae|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Participants|||Number
87782|NCT00930813|Secondary|Target Lesion Revascularization||6, 12, 24 months||||||
87783|NCT00930813|Secondary|Primary Patency of Treated Segment||6, 12, 24 months||||||
87784|NCT00930813|Secondary|Safety - Device Related Adverse Events||30 days|ITT||participants|||Number
87754|NCT00930982|Secondary|24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. Sputum color was assessed as either 'clear', or as 'yellow', 'green' or 'rust', or an assessment of 'no sputum' was made.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percentage of participants|||Number
87755|NCT00930982|Secondary|24-hour Sputum Volume|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. The volume of the completed sample was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||mL||Standard Deviation|Mean
87756|NCT00930982|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC)|Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||giga/L||Standard Deviation|Mean
87757|NCT00930982|Secondary|Change From Baseline in High Sensitive C-reactive Protein (hsCRP)|High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||mg/L||Inter-Quartile Range|Median
87758|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS)|Participants completed the Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges between 1 and 7, 1 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Total score on a scale||Standard Deviation|Mean
87759|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score|Participants completed the Saint George's Respiratory Questionnaire (SGRQ). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges from 0 to 100 with 100 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Scores on a scale||Standard Deviation|Mean
87760|NCT00930982|Secondary|Time to Exacerbation With Antibiotic Intervention|Acute exacerbation was defined according to the joint American Thoracic Society/European Respiratory Society criteria. For detailed information with regard to this definition of acute exacerbation, please refer to the detailed description in the protocol section. The time to an acute exacerbation with antibiotic intervention was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. NA: due to fewer than 25% of participants having an exacerbation||Days||Inter-Quartile Range|Median
87761|NCT00930982|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FVC was defined as the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, i.e. vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS. Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percent of predicted FVC||Standard Deviation|Mean
87762|NCT00930982|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||Percent of predicted FEV1||Standard Deviation|Mean
87763|NCT00930982|Primary|Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and 29 days|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.||log10 of CFU per gram sputum||Standard Deviation|Mean
87786|NCT00930787|Primary|Incidence of Surgical Site Events (SSEs)||Postoperative Day 30|Study was terminated early and no analyses were conducted.|||||
87764|NCT00930969|Secondary|Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.|When study subjects completed their six-month follow-up visit, they were asked if they would consent to wear a Holter monitor for a period of 24 hours to collect Heart Sounds data. The study subject would have to return to the center the following day to return the Holter monitor and have their ICD EGM vectors reprogrammed.|Six-month follow-up visit|A subset of participants opting to wear a Holter monitor for 24 hours to collect Heart Sounds data, and then returning the following day for device reprogramming.||Participants|||Number
87765|NCT00930969|Secondary|Number of Years of Stored Data in a Database of the Hearts Electrical Activity in This Specific Patient Population to be Used for Future Research.|The device in this study included an additional capacity to collect and store information about the hearts electrical activity specific to ischemic heart disease. This additional capacity of the device is not currently available in market release ICDs. There is no measure to this objective, other than reporting the number of follow-up years of data accrued, which can be used by Medtronic for additional research.|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore the number of years of stored device data to utilize for future research as collected by the implanted ICD in the remaining 173 subjects was analyzed.||Years|||Number
87766|NCT00930969|Secondary|ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test|Patients underwent an exercise stress test at their one month study visit. This objective was to summarize the magnitude of the hearts electrical activity signal measured by the implanted ICD during a positive exercise stress test for ischemia.|One-month follow-up visit|||millivolts||Standard Deviation|Mean
87767|NCT00930969|Secondary|Occurrence of Spontaneous Coronary Event|During the study, spontaneous coronary ischemic events were categorized as STEMI, Non-ST elevated myocardial infarction (NSTEMI), or Unstable Angina. This objective was to provide estimates of rates per patient year for the study population. Rates are presented as: Average number of events per patient year (95% Confidence Interval)|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore data collected by the implanted ICD in the remaining 173 subjects was analyzed.||Events per patient year||95% Confidence Interval|Number
87768|NCT00930969|Primary|Number of Participants With ST Segment Changes During Myocardial Infarction|The primary objective of the study was to observe if there are any detectable ST segment changes on an electrogram (EGM) signal from an implanted cardiac defibrillator (ICD) during myocardial infarctions among study participants.|Implant to 2 years|During the study, none of the subjects presented with a ST Elevation Myocardial Infarction (STEMI). Therefore, there was not the opportunity to measure the hearts electrical activity during one of these events.||Participants|||Number
87769|NCT00930930|Other Pre-specified|Ability of p63 and p73 Gene Signatures to Predict Patient Response|To determine the levels of P63 and p73 in order to correlate these levels with patient response to treatment to help define a biomarker signature associated with p63/p73 dependence in triple negative breast cancers|Before treatment, on day 3-5 of week 1, and at week 12||||||
87770|NCT00930930|Other Pre-specified|Therapy-mediated Changes in Cell Cycle Position, Proliferation, and Apoptosis as Well as Status, Levels, and Phosphorylation State of p53, p73, and p63 and Select p53 Family Target Genes|To determine the relevance of pathway modulation in triple negative breast cancer cell networking|Before treatment, on day 3-5 of week 1, and at week 12||||||
87771|NCT00930930|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Tables represent the number of patients with their worst-grade toxicity at each of five grades (grade 1, least severe to grade 5, most severe) following NCI Common Toxicity Criteria. Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables.|week 12|Total number of patients reported with any toxicity related to study treatment.||participants|||Number
87772|NCT00930930|Secondary|Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|After treatment, week 12-15|Patients reported by best overall response data. Patients are excluded if best overall response data is not accessible or not evaluable.||participants|||Number
87773|NCT00930930|Secondary|Number of Patients That Underwent Breast Conservation Surgery|Defined as patients that did not undergo complete removal of a cancerous breast (mastectomy).|at the time of surgery, week 15-18|participants that had breast conservation surgery||participants|||Number
87774|NCT00930930|Primary|Number of Patients With Pathological Complete Response|Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.|at time of surgery, week 15-18|Number of patients that had complete response. Specimens containing only non-invasive disease will be classified as complete pathologic responders||participants|||Number
87775|NCT00930813|Secondary|Serum Paclitaxel Levels - in Subsets of Patients||0, 1, 3 hours and pre-discharge||||||
87776|NCT00930813|Secondary|Change in Rutherford Grade||pre-procedure,6, 12 and 24 months||||||
87777|NCT00930813|Secondary|Change in Walking Impairment Questionnaire (WIQ)||pre-procedure, 6, 12 and 24 months||||||
87778|NCT00930813|Secondary|Change in Ankle-brachial Index||pre-procedure, 6, 12 and 24 months||||||
87779|NCT00930813|Secondary|Procedural Success|Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)|at procedure||||||
87780|NCT00930813|Secondary|Device Success|Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).|at procedure||||||
87781|NCT00930813|Secondary|Target Vessel Revascularization||6, 12, 24 months||||||
87787|NCT00930774|Secondary|Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)|Three subscale questionnaire that examines reported change in auditory disability for Speech, Spatial hearing and Quality of sounds. Subjects respond on a scale of -5 (‘much worse’) to +5 (much better) to indicate the change in difficulties following an intervention they have hearing in specific situations, with a lower number indicating greater difficulty. Results are presented for average total SSQ-C score which can range from -5 to +5, with higher scores indicating greater improvement.|Immediately post-intervention|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
87788|NCT00930774|Secondary|Cognitive Self Report Questionnaire (CSRQ).|CSRQ assesses self-reported cognitive difficulties in 8 domains: Attention, Executive function, Memory, Language, Vision, Hearing, Energy,and Satisfaction. Participants respond on a 3-point Likert scale whether they perceived they improved, remained the same, or got worse as a result of an intervention. Total score is computed by summing scores on each subscale. Range for total score = -64 to +64, with higher scores indicating fewer reported cognitive difficulties.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
87789|NCT00930774|Secondary|Time Compressed Speech Test (TCST)|the TCST assessed speech recognition for speeded speech. Sentences are presented in the sound field in quiet at with 50% and 60% time compression. Participants repeat back each sentence after it is presented.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||percent correct||Standard Deviation|Mean
87790|NCT00930774|Secondary|Digit Span Score Measure of Auditory Working Memory|The Digit Span subtest of the Wechsler Adult Intelligence Scale 3rd edition (WAIS-III) assessed auditory working memory. It consists of a Digit Span Forward task in which individuals to repeat numbers in the same sequence as they were presented verbally, and a Digit Span Backward task in which individuals repeat back the numbers in the reverse order to which they were heard. Data are summed to compute a Digit Span total score. Possible range of scores is 0 to 30, with higher scores indicating better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
87791|NCT00930774|Secondary|Staggered Spondaic Word Test|Dichotic listening test in which two spondaic words are presented, one to each ear of the listener, in an overlapping fashion such that the first syllable of the first word is presented in isolation, the second syllable of the first word is presented simultaneously with the first syllable of the second word, and the second syllable of the second word is presented in isolation. Total number of test spondee pairs = 40.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||total errors||Standard Deviation|Mean
87792|NCT00930774|Secondary|Hearing in Noise Test|Hearing In Noise Test assesses speech understanding in noise assessed. Sentences are presented in a background of noise. The signal to noise ratio is varied adaptively to obtained the signal to noise ratio at which participants can correctly repeat back 50% of sentences presented in speech-shaped noise is determined. A lower signal to noise ratio indicates better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||Decibels (signal to noise ratio)||Standard Deviation|Mean
87793|NCT00930774|Primary|Stroop Color and Word Test|Measure of processing interference that assesses the ability to cope with cognitive stress and process complex input. It consists of a Word Page with color words printed in black ink, a Color Page with 'Xs' printed in color, and a Color-Word Page with words from the first page printed in colors from the second page (the color and the word do not match). The test-taker looks at each sheet and moves down the columns, reading words or naming the ink colors as quickly as possible within a time limit. Interference raw scores were converted into t-scores for analysis. T-score benefit was the analytic metric used. T-score benefit = post-intervention score minus baseline score|Baseline and Immediately post-intervention (between weeks 8 and 12).|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||t-score benefit||Standard Deviation|Mean
87794|NCT00930774|Primary|Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)|Assesses the impact a rehabilitative intervention has on perceived Competence (perceived functional capability, independence and performance). Responses are reported on a 7-point scale that ranges from -3 (maximum negative impact) to +3 (maximum positive impact). The mid-point, zero, indicates no impact or no perceived change|Immediately post-intervention between weeks 8 and 12|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.||units on a scale||Standard Deviation|Mean
87795|NCT00930761|Secondary|Maternal Breastfeeding at 60 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 60 days after the infant hospital discharge|||participants|||Number
87796|NCT00930761|Primary|Maternal Breastfeeding 7-15 Days After Discharge|Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the first follow-up visit (7-15 days after discharge)|Analysis was by intention to treat (ITT)||participants|||Number
87797|NCT00930761|Secondary|Maternal Breastfeeding at 30 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 30 days after the infant hospital discharge|Analysis by intention to treat (ITT)||participants|||Number
87798|NCT00930761|Primary|Maternal Breastfeeding at Infant Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the time of the infant hospital discharge|Analysis by intention to treat (ITT)||participants|||Number
87799|NCT00930722|Secondary|Number of Participants With Preference for add-on Anti-hypertensive Therapy|The first add-on antihypertensive therapy for each participant was the first additional antihypertensive medication since initiation of Quinapril. If the participant did not require any such add-on medication, the first add-on antihypertensive therapy was “None”.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.||Participants|||Number
87800|NCT00930722|Secondary|Mean Daily Dose of Study Medication|The mean daily dose of the study medication was calculated by dividing the total dose (sum of the daily doses) in the study by the treatment duration.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.||mg||Standard Deviation|Mean
87801|NCT00930722|Secondary|Duration of Monotherapy With Quinapril|Time in weeks to the first “taking additional antihypertensive medication” since Quinapril therapy began.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed. Due to limited number of participants available, the analysis could not be performed.||Weeks||Inter-Quartile Range|Median
87802|NCT00930722|Secondary|Number of Participants With Achievement of BP Goal at Week 52|The status of achieving a participant’s goal BP at week 52 was yes (at goal) or no (not at goal). The BP goal also depended on the participant’s status of “DM or renal disease”. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.|Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.||Participants|||Number
87803|NCT00930722|Secondary|Number of Participants Achieving BP Goal at Week 12|The status of achieving a participant’s goal BP at Week 12 was yes (at goal) or no (not at goal). The BP goal also depended on the participant’s status of “Diabetes Mellitus (DM) or renal disease”. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.|Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Subgroup analysis was performed for each subgroup of participants in the FAS defined by DM or renal disease status. Missing values were imputed by LOCF.||Participants|||Number
87804|NCT00930722|Secondary|Change From Pre-treatment in DBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.||mmHg||Standard Deviation|Mean
87805|NCT00930722|Secondary|Change From Pre-treatment in SBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.||mmHg||Standard Deviation|Mean
87806|NCT00930722|Secondary|Change From Baseline in DBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.||mmHg||Standard Deviation|Mean
87807|NCT00930722|Secondary|Change From Baseline in SBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The “full analysis set – follow up” (FAS-FU) included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.||mmHg||Standard Deviation|Mean
87808|NCT00930722|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by LOCF.||mmHg||Standard Deviation|Mean
87809|NCT00930722|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by last-observation-carried forward (LOCF).||Millimeters of mercury (mmHg)||Standard Deviation|Mean
90635|NCT00904150|Primary|Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 G594A|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
87810|NCT00930722|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to Week 52|Full analysis set (FAS) included participants who received at least 1 dose of study medication including those who took it before enrollment.||Participants|||Number
87811|NCT00930644|Secondary|Number of Subjects Achieving PN/IV Reduction|The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.|24 Months or Last Dosing Visit|||participants|||Number
87812|NCT00930644|Primary|Absolute Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.|24 months|||Liters||Standard Deviation|Mean
87813|NCT00930644|Primary|Percent Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.|24 months|||percent change||Standard Deviation|Mean
87814|NCT00930293|Secondary|Weeks to Depression Remission|"Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).~Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)"|Measured at baseline and weekly for up to 20 weeks of treatment|||weeks||Standard Error|Mean
87815|NCT00930293|Primary|Number of Participants Meeting Depression Remission Criteria|Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7|Measured at baseline and weekly for up to 20 weeks of acute treatment|||participants|||Number
87816|NCT00930176|Primary|FX:C Half-life|Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment|At Baseline and at 6 months post-Baseline|||hours||Geometric Coefficient of Variation|Geometric Mean
87817|NCT00930176|Primary|FX:C Incremental Recovery|"Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg).~Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment"|At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)|||IU/dL per IU/kg||Geometric Coefficient of Variation|Geometric Mean
87818|NCT00929981|Secondary|Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits|Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 – 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred).|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Units on a scale||Standard Deviation|Mean
87819|NCT00929981|Secondary|Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits|Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Units on a scale||Standard Deviation|Mean
87820|NCT00929981|Secondary|Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits|Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Units on a scale||Standard Deviation|Mean
87821|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Final Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Final follow-up visit (between Day 25 to 35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
87822|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Third Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Third follow-up visit (between Day 6 to 10 after EOT)|FAS population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
87823|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the First Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|First follow-up visit (between Day 6 to 10 after start of treatment)|FAS population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
87841|NCT00929734|Primary|Relative Change in Reactive Hyperemia Index (RHI)|Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.|Baseline to 3 months|Complete case analysis||percent change||95% Confidence Interval|Mean
87824|NCT00929981|Primary|Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit|The signs and symptoms of CD were rated on Physician’s Global Assessment (PGA) 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Second follow-up visit (Day 5-28)|Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
87825|NCT00929864|Secondary|Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population|The induction of autoantibodies was defined as participant’s antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729). Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline. Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate.|Day 1 to Day 729|ITT population was defined as all participants randomized into the study who received at least one dose of study drug; number analyzed was ITT participants with data at each time point and who had negative ANA or dsDNA at baseline (m)||Percentage of participants||95% Confidence Interval|Number
87826|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 729|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.||incidence/100 person-years||95% Confidence Interval|Number
87827|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.||incidence/100 person-years||95% Confidence Interval|Number
87828|NCT00929864|Secondary|Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population|Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729. BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign). SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films. Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2). Proportion n/m (%)=number meeting criteria (n); number analyzed (m). SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt). mSvdHS=summary of erosion severity in 32 hand and 12 foot joints. Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity. BL: radiographic data within 14 days or less of first dose.|Baseline to Day 729|ITT population: all subjects randomized into the study who received at least one dose of study drug. Number analyzed: m=number of ITT participants with both BL and post-BL total score: Day 365: m=295, 297;Day 729 m=257 and 260, in abatacept and adalimumab arms, respectively. n=number without progression. CI based on normal approximation.||percentage of participants||95% Confidence Interval|Number
87829|NCT00929864|Secondary|Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population|Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25. The 24 Month Period includes data up to 56 days post the last dose in the 24 month period. Poisson distribution used to construct the 95% CIs.|Day 1 to Day 729|ITT population: all participants randomized into the study who received at least one dose of study drug. Participants with a pre-specified local injection site event at 24 Months: 13, 34, in abatacept and adalimumab arms, respectively. 24 Month Exposure=579.21, 532.99, respectively.||incidence/100 person years||95% Confidence Interval|Number
88887|NCT00922207|Secondary|Percentage of Participants Who Were HBeAg Negative||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants||95% Confidence Interval|Number
87830|NCT00929864|Secondary|Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population|n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk. Proportion (%) = n/N. 12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period.|Day 1 to 12 Months|The ITT analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 12/318, 30/328 in abatacept and adalimumab, respectively. CI based on normal approximation.||percentage of participants||95% Confidence Interval|Number
87831|NCT00929864|Primary|The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population|Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 206/318 and 208/328 in the abatacept and adalimumab arms, respectively.||percentage of participants||95% Confidence Interval|Number
87832|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.|baseline and one hour|||degrees||Standard Deviation|Mean
87833|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.|baseline and one hour|||degrees||Standard Deviation|Mean
87834|NCT00929773|Primary|Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.|baseline and one hour|||units on a scale||Standard Deviation|Mean
87835|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment|one hour|||degrees||Standard Deviation|Mean
87836|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment|baseline and one hour|||degrees||Standard Deviation|Mean
87837|NCT00929773|Primary|Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment.|baseline and one hour|||participants|||Number
87838|NCT00929734|Secondary|Relative Change in Interleukin 6||Baseline to 3 months|Complete case analysis||percent change||Inter-Quartile Range|Median
87839|NCT00929734|Secondary|Relative Change in High-sensitivity C-reactive Protein||Baseline to 3 months|Complete case analysis||percent change||Inter-Quartile Range|Median
87840|NCT00929734|Secondary|Relative Change in FEV1||Baseline to 3 months|Complete case analysis||percent change||95% Confidence Interval|Mean
87843|NCT00929708|Secondary|Overall Mean CCQ (Clinical COPD Questionnaire)|Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.|Mean over week 0, mean over week 1, mean over week 2, and mean over week 4|||score on scale||Standard Deviation|Mean
87844|NCT00929708|Secondary|Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)|Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.|Daily, during run-in and treatment|||total score||Standard Deviation|Mean
87845|NCT00929708|Secondary|Total Number of Reliever Medication Inhalations Per 24h|Change from run-in|During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.|||Number of reliver inh.||Standard Deviation|Mean
87846|NCT00929708|Secondary|FEV1 Post Salbutamol Inhalation|Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5|Baseline (visit 2) and 26 h after the last morning dose (visit 5).|||Litre||Standard Deviation|Mean
87847|NCT00929708|Secondary|AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.||nmol*h/L||Full Range|Geometric Mean
87848|NCT00929708|Secondary|Cmax; the Highest Plasma Concentration of AZD3199 Measured|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.||nmol/L||Full Range|Geometric Mean
87849|NCT00929708|Primary|FEV1, E24−26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)|change from baseline|24h, 26h|||Litre||Standard Deviation|Mean
87850|NCT00929708|Primary|FEV1, E0−4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)|change from baseline|0,5 min, 15 min, 60 min, 2 h, 4 h|||Litre||Standard Deviation|Mean
87851|NCT00929695|Secondary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
87852|NCT00929695|Secondary|Chronic Extensive GVHD|Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
87853|NCT00929695|Secondary|Secondary Therapy for Acute GVHD Beyond Prednisone|This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.|At approximately 100 days after transplant|||percentage of participants|||Number
87854|NCT00929695|Secondary|Progression to Grade III-IV Acute GVHD|Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.|At approximately 100 days after transplant|||percentage of participants|||Number
87855|NCT00929695|Secondary|Recurrent or Progressive Malignancy|Percentage of relapse estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
87856|NCT00929695|Secondary|Non-relapse Mortality|Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.|At 12 months after the start of prednisone therapy|||percentage of participants|||Number
87857|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Quality of Life|Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.|Baseline and then every other week until 42 days after starting treatment|||units on a scale||Full Range|Mean
87858|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hypertension|The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.|Baseline and then through 42 days after starting treatment|||medications||Full Range|Mean
87859|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Myopathy|Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.|Baseline and then weekly until 42 days after starting treatment|||units on a scale||Full Range|Mean
87860|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)|The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.|Baseline and through 100 days of treatment|||percentage of participants|||Number
87861|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hyperglycemia|Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.|Baseline and then through 42 days after starting treatment|||mg/dL||Standard Error|Mean
90636|NCT00904150|Primary|Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine|PR PROGINS|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
87862|NCT00929695|Primary|Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment|The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.|At day 42 after initiation of treatment|From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification.||milligrams per kilogram||Standard Deviation|Mean
87863|NCT00929643|Secondary|Percentage of Participants by Diagnosis at Discharge||Month 6 or study exit|FAS||Percentage of participants|||Number
87864|NCT00929643|Secondary|Percentage of Participants With Specific Pathogen||Baseline up to 6 months|FAS||Percentage of participants|||Number
87865|NCT00929643|Primary|Duration of Hospitalization (by Failure of Initial Empiric Treatment)|Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch).|Baseline up to 6 months|FAS; n=number of participants with nonmissing data||Days||Standard Deviation|Mean
87866|NCT00929643|Primary|Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy|Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection.|Baseline up to 6 months|FAS; n=number of participants in which failure could be assessed||Percentage of participants|||Number
87867|NCT00929643|Primary|Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)||Baseline up to 6 months|FAS||Percentage of participants|||Number
87868|NCT00929643|Primary|Duration of Hospitalization|Overall health care resource utilization was analyzed using mean duration of hospitalization.|Baseline up to 6 months|Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.||Days||Standard Deviation|Mean
87869|NCT00929578|Secondary|Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.|Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.|1 week|All participants who were enrolled and completed baseline and week 1 were included.||participants|||Number
87870|NCT00929578|Secondary|Safety Outcome Measures|adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.|8 weeks|All participants who completed enrollment.||participants|||Number
87871|NCT00929578|Secondary|Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks|Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive.|4 weeks|Participants who completed entire trial.||percentage of baseline pruritus||Standard Deviation|Mean
87872|NCT00929578|Primary|Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks|Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores.|4 weeks|All participants who successfully were enrolled.||units on a scale||Standard Deviation|Mean
87873|NCT00929526|Secondary|Number of Subjects With Pregnancies and Pregnancy Outcomes.|Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
87874|NCT00929526|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
87875|NCT00929526|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.||During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
87876|NCT00929526|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.|NOCDs included autoimmune diseases, diabetes mellitus.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
87937|NCT00929162|Secondary|Tumour Response Rate|Objective response rate defined as participants with a complete or partial response according to RECIST|While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)|The number of participants for analysis corresponds to patients with measurable disease at study entry||Participants|||Number
87877|NCT00929526|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.||Subjects|||Number
87878|NCT00929526|Secondary|HPV-16 and HPV-18 Antibody Titers|Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.||Titers||95% Confidence Interval|Geometric Mean
87879|NCT00929526|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.|Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.||Subjects|||Number
87880|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.|"Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between.~HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
87881|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.|"Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days).~For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
87882|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.|HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
87883|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.|"For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
87884|NCT00929526|Secondary|Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC.~HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
87885|NCT00929526|Secondary|Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC.~HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.||Subjects|||Number
87886|NCT00929526|Secondary|Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC).~For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
87938|NCT00929162|Secondary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 2 years|Overall Survival was not analysed as the study was terminated early.|||||
87939|NCT00929162|Primary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.|Patients were followed for progression up to 2 years|||Months||Inter-Quartile Range|Median
87887|NCT00929526|Primary|Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC).~Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR).~For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.||Subjects|||Number
87888|NCT00929474|Secondary|All-cause Cardiovascular and Heart Failure Hospitalizations; All-cause Cardiovascular and Heart Failure Mortality; Changes in Paced/Sensed AV and V-V Delays; Percent Atrial and Ventricular Pacing||Not assessed||||||
87889|NCT00929474|Secondary|6-minute Hall Walk; Intrinsic QRS Width; Echo Measurements (End Diastolic Volume, End Systolic Volume, Ejection Fraction, Left Ventricular Mass, Mitral Regurgitation, Tricuspid Regurgitation, and Interventricular and Intraventricular Mechanical Delays)||Not assessed||||||
87890|NCT00929474|Secondary|Modified Specific Activity Scale (SAS); Quality-of-life (QOL) Score as Measured by Minnesota Living With Heart Failure (MLHF) Questionnaire||Not assessed||||||
87891|NCT00929474|Primary|Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)|The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.|Not assessed||||||
87892|NCT00929383|Secondary|Rate of Restenosis|"The rate of restenosis at 12 months was defined as the degree of residual stenosis greater than 50% as determined by the study sites using the WASID method. There was a 10.4% rate of restenosis >50% or 8 patients out of 77 analyzed. The differences in this analysis population N=77 vs. ITT N= 82 populations results from exclusion of N=4 patients with no stent implanted and N=1 patient who died prior to any follow up measures of restenosis.~The WASID method is a standardized protocol for measuring intracranial arterial stenosis.~[1-(Dstenosis/Dnormal)] x100=% stenosis (where D=vessel diameter)"|12 Months|There were only N=77 patients available for analysis of restenosis at 12 months. This differs from the original N=82 ITT population in that denominator is based on the number of subjects available at 30 day follow up. Five subjects who exited the study at discharge were excluded from the analysis (no stent implanted (4), death (1)).||participants|||Number
87893|NCT00929383|Secondary|Cumulative Stroke Rate at 12 Months|The cumulative stroke rate at 12 months (any stroke or neurological death </= 30 days or any ischemic stroke in territory >/= 31 days is 15.9% or 13 events per 82 patients|12 months|(ITT) Intent-to-treat||participants|||Number
87894|NCT00929383|Primary|Rate of Recurrent Ischemic Stroke in the Target Territory|The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.|12 Months|(ITT) Intent-to-treat||participants|||Number
87895|NCT00929383|Primary|Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)|"Any stroke or neurological death at </= 30 days will be included in the cumulative morbidity and mortality rate.~There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients."|30 days|(ITT) Intent-to-treat||participants|||Number
87896|NCT00929383|Primary|Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)|The number of Wingspan Stents successfully deployed across the target lesion.|Peri-procedural|(ITT) Intent-to-treat||patients w stent implanted|||Number
87897|NCT00929357|Secondary|Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)|Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (<20 EU) or positive (≥20 up to >60 EU).|Baseline (Day 0) up to 48 months|Evaluable population; N=number of participants with evaluable data for CCP. CCP value as a laboratory diagnostic marker was collected within the complete timeframe and was documented only once; calculation for change in value not applicable.||participants|||Number
87898|NCT00929357|Secondary|Number of Participants With Change From Baseline in Rheumatoid Factor (RF)|Rheumatoid Factor measured as a titer and categorized as negative (<1:16 ratio) or positive. A ratio >1:16 indicates a higher level of RF.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for Positive or Negative status for DMARDS and Biologics, respectively.||participants|||Number
87899|NCT00929357|Secondary|Change From Baseline in C-reactive Protein (CRP)|C-reactive protein measured as milligrams per liter (mg/l)|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.||mg/l||Standard Deviation|Mean
87900|NCT00929357|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.||mm/h||Standard Deviation|Mean
87901|NCT00929357|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.||scores on a scale||Standard Deviation|Mean
87902|NCT00929357|Secondary|Number of Participants Without Erosions|Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.|Baseline (Day 0) up to 48 months|Evaluable population. Ratingen scores were calculated based on radiographic assessment, but score of 0 (no erosions) was not reported separately; data not summarized.||participants|||Number
90637|NCT00904007|Secondary|Provider-perceived Barriers and Facilitators to the Spaced Education Intervention||Months 1-12||||||
87903|NCT00929357|Secondary|Number of Participants Without Radiographic Progression|An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.|Baseline (Day 0) up to 48 months|Evaluable population||participants|||Number
87904|NCT00929357|Primary|Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression|Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, <20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 [months])*12 months.|Baseline (Day 0) up to 48 months|Evaluable population: all participants who had provided two evaluable, consecutive radiographs of the hands and forefeet, taken at intervals of 12 to 48 months. Since the time period between the first and second radiograph could range between 12 to 48 months, changes in Ratingen score were to be normalized to 1 year.||scores on a scale||Standard Deviation|Mean
87905|NCT00929331|Secondary|Number of Subjects With Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning up to the end of the study (Day 0 - Day 21)|||subjects|||Number
87906|NCT00929331|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination."|During a 21-day (Day 0-20) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
87907|NCT00929331|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.~Related = general symptom assessed by the investigator as related to the vaccine"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
87908|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.~Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
87909|NCT00929331|Primary|Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value|"The cut-off value was a titer of 1:40.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
87910|NCT00929331|Primary|Seroconversion Factors|"Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||ratio||95% Confidence Interval|Mean
87911|NCT00929331|Primary|Number of Seroconverted Subjects|"A seroconverted subject is a subject who had either a prevaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a four-fold increase in post-vaccination titer.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
87912|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|"The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
87913|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|"The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||subjects|||Number
87914|NCT00929331|Primary|GMTs of HI Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||titer||95% Confidence Interval|Geometric Mean
87915|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.~Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination.~For temperature this means equal to or above 38.0 degrees celsius."|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
87916|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the site of injection.~Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
87917|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the site of injection.~Any = Solicited local symptoms are presented regardless of their intensity grade"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.||subjects|||Number
87918|NCT00929331|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.||titer||95% Confidence Interval|Geometric Mean
87919|NCT00929305|Primary|Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.|baseline and one day|||units on a scale||Standard Deviation|Mean
87920|NCT00929305|Secondary|Muscle Trigger Points of the Cervical Spine||one day||||||
87921|NCT00929305|Secondary|Range of Motion of the Neck and Shoulders||one day||||||
87922|NCT00929305|Primary|The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.|baseline and one day|||participants|||Number
87923|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.||percentage of participants||95% Confidence Interval|Number
87924|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase)|Objective Response was determined by the investigator using RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Pearson-Clopper one-sample method was used for CI.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.||percentage of participants||95% Confidence Interval|Number
87925|NCT00929240|Secondary|Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013)|The EORTC QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ‘’baseline’’ refers to the time of randomization to the maintenance phase.|Baseline, Randomization and Cycles 3, 6, 9 and 12|Maintenance Phase ITT population; n (number) = number of participants analyzed at the specific visit. Only timepoints with more than 10 participants in each treatment arm are presented.||units on a scale||95% Confidence Interval|Mean
87926|NCT00929240|Secondary|Time To Progression (Maintenance Phase Data Cutoff October 4, 2013)|Time to Progression was defined as the time from randomization to the first documented disease progression (using investigator assessments of disease progression by RECIST 1.0). PD was defined as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population||months||95% Confidence Interval|Median
87927|NCT00929240|Secondary|Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013)|PD was defined per RECIST 1.0 as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population||percentage of participants|||Number
87928|NCT00929240|Secondary|Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)|Probability of being alive after 1 and 2 years on treatment with 95% CIs was calculated using Kaplan Meier approach with LOGLOG transformation.|Years 1 and 2|Maintenance Phase ITT Population||percentage of participants||95% Confidence Interval|Number
87929|NCT00929240|Secondary|Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)|Duration of Overall Survival (OS) was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. Kaplan Meier estimation was used to determine OS.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||months||95% Confidence Interval|Median
87930|NCT00929240|Secondary|Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)||Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||percentage of participants|||Number
87931|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||percentage of participants||95% Confidence Interval|Number
87932|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Progressive disease (PD) was defined as 20% increase in the sum of the longest diameter of target lesions and SD was defined as small changes that do not meet above criteria. Pearson-Clopper one-sample method was used for Confidence intervals (CIs).|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT Population||percentage of participants||95% Confidence Interval|Number
87933|NCT00929240|Primary|Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)|PFS was defined as the time from first study drug dosing to the first documented disease progression or death, whichever occurred first.Time to progression was defined as the time from randomization to the first documented disease progression defined per RECIST 1.0 criteria. Participants without an event at data cut-off or who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression free. Participants who took other non-protocol anti-cancer drugs while being on study medication, and who were still event free were censored on the date of first dose of the anti-cancer drug. Participants without post-randomization tumor assessments but alive were censored at the time of randomization. Participants without post-randomization assessments, who died after randomization were considered to have the PFS event at date of death. Kaplan-Meier estimation was used for median time to PFS|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population||months||95% Confidence Interval|Median
87934|NCT00929240|Primary|Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)|Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population: All randomized participants||percentage of participants|||Number
87935|NCT00929201|Secondary|Peak Plasma Concentration (Cmax) of Metformin|Serum samples were used to determine the maximum concentration for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period||ng/mL||Standard Deviation|Least Squares Mean
87936|NCT00929201|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin|Serum samples were used to determine the AUC from time 0 to infinity for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period||μg * hr/mL||Standard Deviation|Least Squares Mean
87940|NCT00929110|Secondary|Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)|The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
87941|NCT00929110|Secondary|Percentage of “Days Able to Perform Usual Daily Activities” During the Study (Baseline to Week 52)|A “day able to perform usual daily activities” was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of “days able to perform usual daily activities” was calculated as the total number of “days able to perform usual daily activities” over the 52 week treatment period divided by the total number of days where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of days||Standard Error|Least Squares Mean
87942|NCT00929110|Secondary|Percentage of Days With “no Daytime Symptoms” During the Study (Baseline to Week 52)|A day with “no daytime symptoms” was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with “no daytime symptoms” was calculated as the total number of days with “no daytime symptoms” over the 52 week treatment period divided by the total number of days where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of days||Standard Error|Least Squares Mean
87943|NCT00929110|Secondary|Percentage of Nights With “no Nighttime Awakenings” During the Study (Baseline to Week 52)|A night with “no nighttime awakenings” was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with ‘no nighttime awakenings’ was calculated as the total number of nights with “no nighttime awakenings” over the 52 week treatment period divided by the total number of nights where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of nights||Standard Error|Least Squares Mean
87944|NCT00929110|Secondary|Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Percentage of participants|||Number
87945|NCT00929110|Secondary|Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)|The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Exacerbations per treatment year||95% Confidence Interval|Number
87946|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87947|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87948|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87988|NCT00928746|Primary|Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations registered by the actuation indicator and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)||Count||95% Confidence Interval|Median
90638|NCT00904007|Secondary|Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention||Months 1-12||||||
87949|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87950|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87951|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87952|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87953|NCT00929110|Secondary|Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52|Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure.|Day 1, Week 12, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87954|NCT00929110|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure.|Day 1, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87955|NCT00929110|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Puffs||Standard Error|Least Squares Mean
87956|NCT00929110|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Days||Full Range|Median
87957|NCT00929110|Secondary|Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52|The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.|Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
87989|NCT00928746|Primary|Actuations Dispensed|Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)||Count||Standard Deviation|Median
87958|NCT00929110|Secondary|Transition Dyspnea Index (TDI) at Week 26|The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.|Week 26|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Units on a scale||Standard Error|Least Squares Mean
87959|NCT00929110|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.|Week 12|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.||Liters||Standard Error|Least Squares Mean
87960|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Investigator|Investigators assessment of immediate post-injection pain severity using Thermometer Pain Scale (TPS) with a range of 0-10 where 0=no pain and 10=worst possible pain|immediate post injection|||units on a scale|Participants|Standard Deviation|Mean
87961|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Subject|Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100).|immediate post-injection|||units on a scale|Participants|Standard Deviation|Mean
87962|NCT00928954|Primary|Percent Change in Median Eye Speed|Median eye speed during attempted visual fixation by each eye|After 2 weeks of therapy, for both drugs|||Percent change|||Number
87963|NCT00928954|Primary|Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing||After 2 weeks of therapy, for both drugs|||logMAR|||Number
87964|NCT00928889|Secondary|Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)|Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. GSA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||Percentage||Standard Deviation|Mean
87965|NCT00928889|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)|Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. hsCRP was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mg/dL||Standard Deviation|Mean
87966|NCT00928889|Secondary|Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)|Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. FFA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
87967|NCT00928889|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
87968|NCT00928889|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. LDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
87969|NCT00928889|Secondary|Change From Baseline in Triglycerides at the End of the Study (Week 4)|Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Triglycerides were assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
87990|NCT00928746|Primary|Actuations Registered by the Actuation Indicator|This outcome measure presents the number of actuations (doses) of medication used in the specific time frame as measured by the actuation indicator|21 Days|The primary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
87991|NCT00928720|Secondary|Differences in Brain Activity in Pain Processing Regions Between the Active CES and Sham Device Groups in a Subset of 12 Participants (6 in Each Device Group) Using fMRI||at baseline and week 8||||||
87970|NCT00928889|Secondary|Change From Baseline in Total Cholesterol at the End of the Study (Week 4)|Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Total cholesterol was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
87971|NCT00928889|Secondary|Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol*min/L||Standard Deviation|Mean
87972|NCT00928889|Secondary|Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
87973|NCT00928889|Primary|Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.||mmol/L||Standard Deviation|Mean
87974|NCT00928746|Secondary|Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87975|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87976|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87977|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87978|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Performance of the Dose Counter for Indicating Approximately How Many Doses Remain in Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87979|NCT00928746|Secondary|Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87980|NCT00928746|Secondary|Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87981|NCT00928746|Secondary|Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||participants|||Number
87982|NCT00928746|Secondary|Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||95% Confidence Interval|Median
87983|NCT00928746|Secondary|Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations based on advancing the actuation indicator to a zero reading or to the next increment and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||95% Confidence Interval|Median
87984|NCT00928746|Secondary|Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed|Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||95% Confidence Interval|Median
87985|NCT00928746|Secondary|Actuations Registered by the Actuation Indicator and Read by Site Coordinator||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
87986|NCT00928746|Secondary|Actuations Based on Advancing the Actuation Indicator|Actuations based on advancing the actuation indicator to a zero reading or to the next increment|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
87987|NCT00928746|Secondary|Actuations Recorded on Patient Diary||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).||Count||Standard Deviation|Median
87996|NCT00928720|Secondary|Sleep Disturbances and Sleep Quality Using Wrist Actigraph and Sleep Diary, General Sleep Disturbance Scale, and Pittsburgh Sleep Quality Index||wear actigraph and keep sleep diary for 96 hrs at baseline and weeks 4 and 8; GSDS at baseline and weekly over 8 weeks; PSQI at baseline and weeks 4 and 8||||||
87997|NCT00928720|Secondary|Fatigue Using Lee's Fatigue Scale|A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale|at baseline and weekly over 8 weeks||||||
87998|NCT00928720|Primary|Pain Intensity Using Numeric Rating Scale|A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity|week 8|||units on a scale||Standard Deviation|Mean
87999|NCT00928694|Primary|Maximum Plasma Concentration (Cmax) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45||μg/mL||Standard Deviation|Least Squares Mean
88000|NCT00928694|Primary|Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45||μg·hr/mL||Standard Deviation|Least Squares Mean
88001|NCT00928668|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline to Visit 6|All patients in the Safety set who have a baseline value and post dose values for each planned time.||mmol/L||Inter-Quartile Range|Geometric Mean
88002|NCT00928668|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|5 days|The safety set included all patients who received any study medication.||percentage of participants|||Number
88003|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours|32 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
88004|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours|8 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
88005|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours|4 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
88006|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes|30 minutes post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
88007|NCT00928668|Primary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours|24 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
88008|NCT00928642|Secondary|To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.|The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.|Until disease progression||||||
88009|NCT00928642|Secondary|To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)|"Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.~Repsonse rate was the sum of Complete Repsonse and Partial Response."|until disease progression or unacceptable toxicity|All subjects were assessed after 6 weeks of treatment and reassessed at 6 week intervals||participants|||Number
88010|NCT00928642|Secondary|To Determine the Distribution of the Overall Survival|All subjects were followed after treatment was complete to assess overall survival.|Until death|||months||Full Range|Median
88011|NCT00928642|Secondary|Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.|"Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as complete response, partial response, stable disease, and progressive disease after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.~the measurement reported is the number of patients who met the criteria for partial response."|Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified|All subjects who underwent treatment and participated in the study were analysed||participants|||Number
88012|NCT00928642|Primary|To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria|Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria|Until disease progression or unacceptable toxicity|||participants|||Number
88109|NCT00928083|Secondary|OZ439 AUC0-t|Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
88013|NCT00928642|Primary|The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.|Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.|Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.|of 8 enrolled subjects, 7 were eligible for analysis of progression-free survival at 8 months. One subject declined to continue treatment||participants|||Number
88014|NCT00928512|Secondary|Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16|Blood for ESR, which is helpful to diagnose inflammatory diseases and to monitor disease activity and response to therapy, was obtained at the visits.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||mm/hr||Standard Error|Least Squares Mean
88015|NCT00928512|Secondary|Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)|Blood for this assessment was obtained at the visits in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.Since the results of this test may have unblinded study personnel, results from the central lab were provided for screening and baseline only. The hsCRP results from samples collected during the treatment period were revealed only after final database lock.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||mg/L||Standard Error|Least Squares Mean
88016|NCT00928512|Secondary|Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16|HAQ© was used to assess physical ability and functional status of patients as well as quality of life at the visits in these 8 categories assessed by the Disability Index: dressing & grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Patients report amount of difficulty they have in performing 2 or 3 specific activities. There are 4 possible responses (0, 1, 2, 3) for these questions which include types of assistance, if any; the participant uses for his/her usual activities: 0: without any difficulty- No assistance is needed; 1: with some difficulty - A special device is used by the patient in his/her usual activities; 2: with much difficulty - The patient usually needs help from another person. 3: Unable to do - the patient usually needs both a special device and help from another person. Scores of 0 - 1 are generally considered to represent mild to moderate difficulty, 1-2 moderate to severe disability, and 2 -3 severe to very severe disability.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale||Standard Error|Least Squares Mean
88017|NCT00928512|Secondary|Change From Baseline in ACR Component: Physician’s Global Assessment of Disease Activity at Week 16|"The physician’s global assessment of disease activity was performed at the visits usingon a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||VAS in mm||Standard Error|Least Squares Mean
88018|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16|"The patient’s global assessment of disease activity was performed at the visits on a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||VAS in mm||Standard Error|Least Squares Mean
88019|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16|"The patient's assessment of pain was performed at all visits using 100 mm visual analog scale (VAS) ranging from no pain to unbearable pain after the question Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||VAS in mm||Standard Error|Least Squares Mean
88020|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16|The ACR tender joint count (28 joints) was done by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., T) was less than 28, the number of tender joints (e.g., t) was scaled up proportionately (i.e., 28*(t/T)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||tender joints||Standard Error|Least Squares Mean
88021|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient’s ‘global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission.The DAS28 was also derived using erythrocyte sedimentation rate (ESR) (referred to as DAS28-ESR).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale||Standard Error|Least Squares Mean
88022|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16|Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for swollen joint count. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. Whenever possible, the same evaluator performed these assessments at all visits. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., S) was less than 28, the number of swollen joints (e.g., s) was scaled up proportionately (i.e., 28*(s/S)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||swollen joints||Standard Error|Least Squares Mean
88023|NCT00928512|Secondary|Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16|Only values that were above normal range (20 units) were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Units||Standard Deviation|Mean
88024|NCT00928512|Secondary|Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16|Only values that were above normal range (12 U/mL) were were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||U/mL||Standard Deviation|Mean
88025|NCT00928512|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16|The distribution of EULAR response criteria was according to DAS28-CRP at Week 16. EULAR response criteria are based on DAS28-CRP status in combination with DAS28-CRP improvements. The EULAR response criteria are as follows: Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement >1.2 corresponds to 'good response'; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement between 0.6 to 1.2, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement >1.2 or from 0.6 to 1.2, or WeeK 16 DAS28-CRP >5.1 with DAS28-CRP improvement >1.2 correspond to 'moderate response; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP >5.1 with DAS28-CRP improvement between 0.6 to 1.2 or <0.6 correspond to 'no response'.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Percentage of participants|||Number
88026|NCT00928512|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16|The Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeThe scale score was computed by summing the item scores, after reversing those items that were worded in the negative direction. When there were missing item scores, the subscale score was computed by summing the non-missing item scores, multiplying by 13 (the total number of items in the scale) and dividing by the number of non-missing items. The latter rule applied only when at least half of the items (seven or more) were non-missing. FACIT-Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale-change from baseline||Standard Deviation|Mean
88027|NCT00928512|Secondary|Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)|The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) which can be aggregated to derive a physical-component summary score and a mental-component score. Scores are normally determined with the use of norm-based methods which standardize scores based on an assessment of the general U.S. population free of chronic conditions. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with the higher scores indicative of better health.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale-change from baseline||Standard Deviation|Mean
89446|NCT00915356|Primary|Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)|Conversion of AF to SR with maintenance of SR maintained for at least 1 minute|Within 90 minutes from start of infusion|||Percentage of patients converted to SR||95% Confidence Interval|Number
88028|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient’s ‘global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission. The DAS28-CRP was derived from swollen joint count, tender joint count, hsCRP and patient’s global assessment of disease activity.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||scores on a scale||Standard Error|Least Squares Mean
88029|NCT00928512|Secondary|Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16|A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if he/she had as least a 20%, 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assessed disability and acute phase rectant or Erythrocyte sedimentation rate (ESR).|at Weeks2, 4, 8, 12, 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Participants|||Number
88030|NCT00928512|Secondary|Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16|A participant was considered as improved according to the ACR50 or ACR70 criteria if he/she had at least a 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient self-assessed disability (Health Assessment Questionnaire [HAQ©] score) and Acute phase reactant (C-reactive protein [hsCRP]/ESR). Participants were defined as ACR50/70 responders at a given post-randomization visit if they satisfied the ACR50/70 criteria, respectively. Participants were considered ACR50/70 nonresponders if they failed the ACR50/70 criteria respectively. Participants who prematurely discontinued from study due to insufficient therapeutic effect were also considered nonresponders.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Participants|||Number
88031|NCT00928512|Primary|Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks|A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire [HAQ©] score)and acute phase rectant (C-reactive protein [hsCRP]/ESR).|16cweeks|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.||Participants|||Number
88032|NCT00928486|Secondary|Kaplan-Meier Estimates of Duration of Response (DoR)|Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia >11.5mg/dL|From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders||weeks||95% Confidence Interval|Median
88033|NCT00928486|Secondary|Myeloma Response Rate|Overall myeloma response rate was determined by the investigator using the Myeloma Response Determination Criteria adapted from Bladé criteria. A responder is any patient who showed at least a partial response. Overall myeloma response rate is defined as the percentage of participants who achieved a Complete Response (CR), plus a Remission Response (RR), plus a Partial Response (PR). A CR is the disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks. RR is a 75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. PR is a 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion.|From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria||percentage of participants|||Number
88044|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Erection|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88034|NCT00928486|Primary|Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)|A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks|Safety population included all 25 participants who received at least one dose of study drug.||participants|||Number
88035|NCT00928434|Secondary|Percent Change From Baseline in Serum Testosterone Levels|Percent change from Baseline in serum testosterone levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percent change||Standard Deviation|Mean
88036|NCT00928434|Secondary|Absolute Change From Baseline in Serum Testosterone Levels|Absolute Change From Baseline in Serum Testosterone Levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||ng/mL||Standard Deviation|Mean
88037|NCT00928434|Secondary|Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level|The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Days||95% Confidence Interval|Median
88038|NCT00928434|Secondary|Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group|The time to testosterone >0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Days||95% Confidence Interval|Median
88039|NCT00928434|Secondary|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.|At 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percentage of patients||95% Confidence Interval|Number
88040|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score|The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88041|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88042|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88043|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88045|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88046|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score|The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88047|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88048|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88049|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88050|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88077|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at end of treatment (last dose received)|Up to Month 12|Full Analysis Set||mg/day||95% Confidence Interval|Mean
88078|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 12|Month 12|Full Analysis Set - Participants with Observed Data||mg/day||95% Confidence Interval|Mean
88079|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 6|Month 6|Full Analysis Set - Participants with Observed Data||mg/day||95% Confidence Interval|Mean
88080|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 3|Month 3|Full Analysis Set - Participants with Observed Data||mg/day||95% Confidence Interval|Mean
88081|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at initiation of treatment|Initiation of treatment|Full Analysis Set||mg/day||95% Confidence Interval|Mean
88082|NCT00928395|Secondary|Change in Voiding Diary Parameters.||every three months for 36 months||||||
88051|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy–Prostate (FACT-P) : Physical Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Scores on a scale||95% Confidence Interval|Mean
88052|NCT00928434|Secondary|Percent Change From Baseline in Serum PSA Levels|Percent change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percent change||Standard Deviation|Mean
88053|NCT00928434|Secondary|Absolute Change From Baseline in Serum PSA Levels|Absolute change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||ng/mL||Standard Deviation|Mean
88054|NCT00928434|Primary|Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL|Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.|At 14 month|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.||Percentage of patients||95% Confidence Interval|Number
88055|NCT00928421|Primary|Responders to Treatment, Assessed by Duplex Ultrasound|Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.|8 weeks|||participants|||Number
88056|NCT00928408|Primary|Reason for Prescribing Cinacalcet||Initiation|Full Analysis Set||Participants|||Number
88057|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data||Percent change||Inter-Quartile Range|Median
88058|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data||Percent change||Inter-Quartile Range|Median
88059|NCT00928408|Primary|Change From Baseline to Month 12 in Albumin-corrected Serum Calcium||Baseline to Month 12|Full Analysis Set - Participants with Observed Data||mmol/L||Standard Error|Mean
88060|NCT00928408|Primary|Change From Baseline to Month 6 in Albumin-corrected Serum Calcium||Baseline to Month 6|Full Analysis Set - Participants with Observed Data||mmol/L||Standard Error|Mean
88061|NCT00928408|Primary|Change From Baseline to Month 3 in Albumin-corrected Serum Calcium||Baseline to Month 3|Full Analysis Set - Participants with Observed Data||mmol/L||Standard Error|Mean
88062|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12||Month 12|Full Analysis Set - Participants with Observed Data||Participants|||Number
88063|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6||Month 6|Full Analysis Set - Participants with Observed Data||Participants|||Number
88064|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3||Month 3|Full Analysis Set - Participants with Observed Data||Participants|||Number
88065|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12|Baseline is pre-cinacalcet.|Month 12|Full Analysis Set - Participants with Observed Data||Participants|||Number
88066|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6|Baseline is pre-cinacalcet.|Month 6|Full Analysis Set - Participants with Observed Data||Participants|||Number
88067|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3|Baseline is pre-cinacalcet.|Month 3|Full Analysis Set - Participants with Observed Data||Participants|||Number
88068|NCT00928408|Primary|Duration of Exposure to Cinacalcet|Time from first dose to last non-zero dose on study|12 months|Full Analysis Set||Days||Inter-Quartile Range|Median
88069|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation||>6 months after initiation|Full Analysis Set - Participants with Observed Data||Participants|||Number
88070|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation||>3 to 6 months after initiation|Full Analysis Set - Participants with Observed Data||Participants|||Number
88071|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation||Initiation to Month 3|Full Analysis Set||Participants|||Number
88072|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at end of treatment|Up to Month 12|Full Analysis Set||Participants|||Number
88073|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 12|Month 12|Full Analysis Set - Participants with Observed Data||Participants|||Number
88074|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 6|Month 6|Full Analysis Set - Participants with Observed Data||Participants|||Number
88075|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 3|Month 3|Full Analysis Set - Participants with Observed Data||Participants|||Number
88076|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at initiation of treatment|Initiation of treatment|Full Analysis Set||Participants|||Number
88085|NCT00928395|Primary|"Proportion of Patients Reporting Moderately or Markedly Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline"|The GRA asked patients, “Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?” and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).|36 months total|||Proportion of Patients||95% Confidence Interval|Number
88086|NCT00928304|Secondary|Consistency Between Visual and Quantitative Efficacy|For a comparison of the results of the visual assessment with the quantitative assessment, descriptive Standardized Uptake Value Ratio (SUVR) statistics were computed separately for DS subjects with an abnormal/normal majority read of the PET scan (DS-PET+/DS-PET-). The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min|||SUVR||Standard Deviation|Mean
88087|NCT00928304|Secondary|Quantitative Parameters Standard Uptake Value Ratio|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min p.i.|All Down Syndrome subjects and healthy volunteers enrolled in the study were included in this analysis||SUVR||Standard Deviation|Mean
88088|NCT00928304|Secondary|Sensitivity Results in the Down Syndrome Age Subgroups|The majority read sensitivity (percentage of DS subjects positive for cerebral beta-amyloid by majority read) was computed for the group of DS subjects with age equal to or below the median age (DS-young) and for DS subjects with age above the median age (DS-old). The median age was 46 yrs, with 3 subjects being exactly 46 yrs old. As defined, these subjects were assigned to the DS-young group.|100 - 120 min|All Down Syndrome subjects (n=39) were analyzed for this outcome.||percentage of subjects||95% Confidence Interval|Number
88089|NCT00928304|Primary|Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome|The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.|100-120 min|All subjects in the down syndrome population and healthy volunteers were included in this analysis.||percentage of subjects||95% Confidence Interval|Number
88090|NCT00928187|Secondary|Proportion of Patients With HIV Plasma Viral Load < 200 Copies/ml|proportion of patients having a plasma viral load below 200 copies/ml at week 24|Week 24|ITT||Participants|||Count of Participants
88091|NCT00928187|Secondary|Proportion of Patients With HIV Plasma Viral Load < 50 Copies/ml|Snapshot of patients with HIV viral load less then 50 copies/ml at week 24|Week 24|ITT||Participants|||Count of Participants
88092|NCT00928187|Secondary|Incidence of Metabolic Syndrome|proportion of patients developing metabolic syndrome over a period of 48 weeks|from baseline to week 48|population with data available||participants|||Number
88093|NCT00928187|Secondary|Number of Patients With Resistance Mutations|number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml)|between W12 and W48|patients who failed second line (2 HIV RNA measure above 1000 copies/ml)||participants|||Number
88094|NCT00928187|Secondary|Adherence|number of patients in different categories of adherence as measured by questionnaire|between baseline and W48|patients with data available||participants|||Number
88095|NCT00928187|Secondary|Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)|evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value|between baseline and W48|ITT||participants|||Number
88096|NCT00928187|Secondary|Tolerance: Neuropathies (Grade 1 to 4)|any symptom of peripheral neuropathy|between baseline and W48|ITT||participants|||Number
88097|NCT00928187|Secondary|Tolerance: Gastrointestinal Complains|Gastrointestinal complaints (grade 1 to 4) between baseline and W48.|between baseline and 48 weeks|ITT||participants|||Number
88098|NCT00928187|Secondary|Number of Patients Discontinuing Study Treatment|number of patients discounting treatment because of adverse events|between baseline and W48|ITT||participants|||Number
88099|NCT00928187|Secondary|Gain in CD4 Cells Between Baseline and W48|median gain in circulating CD4 cells between baseline and W48|between baseline and 48 weeks|ITT with data available||cell/mm3||Inter-Quartile Range|Median
88100|NCT00928187|Secondary|Patients With Plasma HIV RNA < 200 Copies/ml|number of patients with plasma HIV RNA below 200 copies/ml|48 weeks|ITT||participants|||Number
88101|NCT00928187|Secondary|Number of Patients With WHO Stage 3 and 4 HIV Related Events|patients having a diagnosis of HIV related event classified as stage 3 or 4|between baseline and 48 weeks|ITT||participants|||Number
88102|NCT00928187|Primary|Number of Patients With Plasma HIV RNA < 50 Copies/mL||48 weeks|ITT||participants|||Number
88103|NCT00928174|Primary|Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT|The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.|Concurrent with PET Procedure|Outcome Measure Data Table reflects data from the 22 subjects completing the current study.||%PET-positive cases in a given PSA range|||Number
88104|NCT00928083|Secondary|OZ439 Rac|"Accumulation index is the ratio of drug exposure observed during a dosing interval at steady-state divided by drug exposure after a single first dose, as described by the following equations:~Accumulation index (Rac) = AUC0-(Day 3)/ AUC0-(Day 1)"|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population received multiple dosing only. This PK parameter is not applicable in a single dose setting.||ratio||Geometric Coefficient of Variation|Geometric Mean
90639|NCT00904007|Secondary|Provider-perceived Effectiveness of Spaced Education Intervention||Months 1-12||||||
88110|NCT00928083|Primary|Adverse Events|Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.|From screening and at 10 (+/-2) days after last dose of study medication|||participants|||Number
88111|NCT00928070|Secondary|Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12|PVR volume is defined as volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||mL||Standard Deviation|Mean
88112|NCT00928070|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline|Screening, Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
88113|NCT00928070|Secondary|Mini Mental State Examination (MMSE)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.|Screening|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
88114|NCT00928070|Secondary|Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response|"Participant's response to question, overall, how satisfied are you with your OAB medication? was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into satisfied, and 4 and 5 were combined into dissatisfied."|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.||percentage of participants|||Number
88115|NCT00928070|Secondary|Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control|OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.||units on a scale||Standard Deviation|Mean
88116|NCT00928070|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4, 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. LOCF method was used to impute Week 12 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.||units on a scale||Standard Error|Least Squares Mean
88117|NCT00928070|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.||units on a scale||Standard Deviation|Mean
88118|NCT00928070|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.||units on a scale||Standard Error|Least Squares Mean
88153|NCT00927992|Primary|Number of Participants Who Survived After Liver Transplantation|Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
88119|NCT00928070|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.||units on a scale||Standard Deviation|Mean
88120|NCT00928070|Secondary|Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.|Screening, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||percentage of participants|||Number
88121|NCT00928070|Secondary|Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12|Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'n' is signifying those participants of the population subsets who were evaluated for this measure at the time point for each group respectively.||undergarments||Standard Deviation|Mean
88122|NCT00928070|Secondary|Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
88123|NCT00928070|Secondary|Frequency-Urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
88124|NCT00928070|Secondary|Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
88125|NCT00928070|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
88126|NCT00928070|Secondary|Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
88127|NCT00928070|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
90640|NCT00904007|Secondary|Provider-perceived Acceptability of Spaced Education Intervention||Months 1-12||||||
88128|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
88129|NCT00928070|Secondary|Mean Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
88130|NCT00928070|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
88131|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Error|Least Squares Mean
88132|NCT00928070|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Deviation|Mean
88133|NCT00928070|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
88134|NCT00928070|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.||episodes per 24 hours||Standard Error|Least Squares Mean
88135|NCT00928070|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
88136|NCT00928070|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS) population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
88137|NCT00928057|Other Pre-specified|Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size|If insulin leakage from the injection site was observed, subjects rated the size of the leakage droplet based on a visual scale provided in their diaries. Scores of 1+, 2+, 3+, and 4+ correspond to droplet sizes of 1, 10, 20 and 50 ul, respectively. Droplets larger than those shown on the scale were scored as 5+. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks|The number of participants shown is the number of subjects that reported at least one event of leakage (see previous data table). The number of reported leakage events is presented for each droplet size category. No data were collected if there was no leakage.||number of events|||Number
88138|NCT00928057|Secondary|Relative Injection Pain Score Assessed by Subject|After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with “as painful”, and at the extreme ends with “much less painful” (-75mm) and “much more painful” (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference.|Visit 4: 18-24 days after starting 2nd pen needle|Of the 167 subjects that completed the study, 137 subjects had within-window VAS pain scores for Visit 4 and were included in this analysis. Per the protocol, the allowable visit window was 18-24 days from Visit 3, when the subject switched from the 1st to 2nd assigned pen needle.||mm||Standard Error|Mean
88139|NCT00928057|Other Pre-specified|Percentage of Subjects With at Least One Leakage Event|After each insulin injection with a study pen needle, subjects recorded in their study diary if they observed insulin leakage from the injection site. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks|||percent of subjects|||Number
88140|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hyperglycemic Events|Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.||participants|||Number
88141|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hypoglycemic Events|Severe Unexplained Hypoglycemia is defined as an event in which the subject’s blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.||participants|||Number
88142|NCT00928057|Secondary|Percent Absolute Change in Fructosamine, by Dose Group|"Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:~%|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|"4 of the 167 completed subjects were excluded for out of window fructosamine samples (3), or lab error with a sample (1).~For 4 mm/8 mm: this includes 45 subjects in the Low Dose insulin group and 35 in the Regular Dose group. For 4 mm/5 mm: this includes 47 subjects in the Low Dose insulin group and 36 in the Regular Dose group."||Percent absolute change||95% Confidence Interval|Mean
88143|NCT00928057|Primary|Percent (%) Absolute Change in Fructosamine|"Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:~Percent absolute change in FRU, or %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|167 subjects completed the study. 163 of the 167 completed subjects were included in this analysis. Four (4) of 167 were excluded due to out of window fructosamine samples (3), or laboratory error with fructosamine sample (1).||Percent absolute change||95% Confidence Interval|Mean
88144|NCT00928018|Secondary|To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied.||2 years|Given the small number of patients within each group, we considered indolent histologies (indolent B-cell NHL, CLL and HL) together in one group (indolent group), and aggressive histologies (aggressive B-cell NHL, MCL, and T-cell NHL) in another (aggressive group).||percentage of participants|||Number
88145|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms.||2 years|||percentage of participants|||Number
88146|NCT00928018|Secondary|To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms||6 months|||percentage of participants|||Number
88147|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms||2 years|||percentage of participants||95% Confidence Interval|Number
88148|NCT00928018|Secondary|To Compare 2-year Progression-free Survival Between the Two Treatment Arms||2 years|||percentage of participants||95% Confidence Interval|Number
88149|NCT00928018|Primary|To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil||2 years|||percentage of participants||95% Confidence Interval|Number
88150|NCT00927992|Secondary|Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation||Post liver transplantation up to Month 3|Data was not analyzed as only hemophiliac participants were enrolled in the study.|||||
88151|NCT00927992|Secondary|Dose of Exogenous Clotting Factors Used During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.||International Unit/kilogram (IU/kg)||Standard Deviation|Mean
88152|NCT00927992|Secondary|Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
88256|NCT00927355|Secondary|βCTX (Carboxy Terminal Collagen Crosslinks), Osteocalcin, and Adiponectin.||6 months|||percent change from baseline||Standard Error|Mean
88154|NCT00927992|Primary|Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation|Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
88155|NCT00927992|Primary|Number of Participants With Acute Rejection of Liver Transplant|Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
88156|NCT00927992|Primary|Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation|Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.||Participants|||Number
88157|NCT00927953|Secondary|Time to a >= 1 Point Reduction in the Modified Rankin Scale Score||Study Day 2, 7, 14, 28, and 120|Intention to treat (ITT)||Days||95% Confidence Interval|Median
88158|NCT00927953|Secondary|Mean Modified Rankin Scale Scores|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead."|Study Day 0, 2, 7, 14, 28, and 120|||units on a scale||Standard Deviation|Mean
88159|NCT00927953|Secondary|The Number of Participants With a Favorable Neurologic Outcome|"Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is <=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead."|Study Day 2, 7, 14, 28, and 120|||participants|||Number
88160|NCT00927953|Primary|The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event|Includes adverse events considered possibly, probably, or definitely related to study drug|120 days|Intention to treat (ITT)||participants|||Number
88161|NCT00927953|Primary|The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead"|Study Day 2, 7, 14, 28, and 120|All randomized participants with confirmed West Nile virus infection||participants|||Number
88162|NCT00927940|Secondary|Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)||8 months||||||
88163|NCT00927940|Secondary|Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis||12 months||||||
88164|NCT00927940|Secondary|Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)|Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.|12 months|ITT population||percentage of participants with TLF|||Number
88165|NCT00927940|Primary|In-stent Late Lumen Loss (LLL)|The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD|Post procedure, 8 Months|Actually a patient was excluded from this analysis because of death before 30 days follow up.||mm||Standard Deviation|Mean
88166|NCT00927927|Secondary|Area Under the Concentration-time Curve (AUC)|Systemic exposure to NNC0142-0002.|Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. Serum drug concentrations after dosing with less than 0.175 mg/kg (SD cohorts) and 0.3 mg/kg (MD cohorts) were below the lower limit of quantification.||microgram×h/mL||Geometric Coefficient of Variation|Geometric Mean
88167|NCT00927927|Primary|Frequency of Adverse Events|Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.|Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.||events|||Number
88168|NCT00927901|Secondary|Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
88273|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||micrometer (µm)||Inter-Quartile Range|Median
88169|NCT00927901|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.||pg * hr/mL||Geometric Coefficient of Variation|Geometric Mean
88170|NCT00927901|Secondary|Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period|Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs > 0) was included to calculate endpoint.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Percentage of participants|||Number
88171|NCT00927901|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.|Day 1 and Day 7|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Hours||90% Confidence Interval|Median
88172|NCT00927901|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.|Baseline to Day 1|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||90% Confidence Interval|Least Squares Mean
88173|NCT00927901|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.||Liters||90% Confidence Interval|Least Squares Mean
88174|NCT00927888|Secondary|SNOT-20 Surgical Outcome Score|"This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units).~ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41–47"|1-day|Entire study population included.||units on a scale|Participants|Standard Deviation|Mean
88175|NCT00927888|Primary|Postoperative Pain Assessed on Standard VAS Scale|Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible.|VAS Pain Score at 7 days|Entire population of both groups.||units on a scale|Participants|Standard Deviation|Mean
88176|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 in the Pharmacogenetic (PG)-Guided Dosing Arms and the Parallel Control Arm|What is reported is the percent of patients with an INR ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.||percent||Standard Deviation|Mean
88177|NCT00927862|Primary|The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls|The percent of time in therapeutic INR range for the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) guided patients and parallel controls. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.||percent||95% Confidence Interval|Mean
88178|NCT00927862|Primary|The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms.|The percent of time in therapeutic INR range for the standard and modified pharmacogenetic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.||percent||95% Confidence Interval|Mean
88179|NCT00927862|Primary|The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls|The percent of out of range (OOR) INRs in the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) and parallel controls. A 10% margin outside of the target INR range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with OOR INRs at 1 month.|1 month (from day 3 to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls||percent||95% Confidence Interval|Mean
89498|NCT00915278|Secondary|Number of Participants With Tissue Macrophage Infiltration|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against tissue macrophages.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
88180|NCT00927862|Secondary|Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls|Prediction of a stable maintenance dose (within 1 mg/day) among the pharmacogenetic (PG)-guided dosing and the parallel control group. For the parallel control group, an empiric starting dose of 5 mg/day was assumed. What is reported is the percent of patients who had their maintenance dose predicted as described above.|3 months (from baseline to 3 months or until stable dosing is achieved, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) and had a stable maintenance dose that could be determined were compared to parallel controls||percent|||Number
88181|NCT00927862|Secondary|The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls.|What is reported is the mean number of INRs measured/drawn among the patients in each arm.|1-3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls||INRs||Standard Deviation|Mean
88182|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm.|What is reported is the percent of patients with INRs ≥4 or ≤1.5 or having experienced a serious adverse event (SAE) at the end of follow-up.|3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|All patients receiving at least 1 dose of warfarin were included in safety analyses until 1 week after the last warfarin dose||percent|||Number
88183|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm|The percent of INRs ≥4 or ≤1.5 for the pharmacogenetic (modified IWPC warfarin algorithm and the standard IWPC warfarin) algorithms. What is reported is the percent of patients with INRs ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|All consented, randomized patients who were successfully genotyped and received at least 1 dose of warfarin with at least 1 postdose INR.||percent||Standard Deviation|Mean
88184|NCT00927862|Primary|The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms.|The percent of out of range (OOR) international normalized prothrombin time ratio (INRs) in the standard and modified pharmacogentic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin outside of the target range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with an OOR INR at 1 month.|1 month (from day 3 to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.||percent||95% Confidence Interval|Mean
88185|NCT00927849|Primary|Relieve of Anal Pain|using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 ( severe pain)|one year after the procedure|||score in scale||Standard Deviation|Mean
88186|NCT00927849|Primary|Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal|effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery|one year||||||
88187|NCT00927823|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected|Response analysis set included all participants who started treatment and had an adequate baseline tumor assessment.||participants|||Number
88188|NCT00927823|Secondary|Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue|Biopsied tumor tissue was analyzed for alterations in the phosphoinositide-3-kinase/rat sarcoma (PI3K/RAS) signaling pathway by molecular approaches. The biomarkers studied were phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) gene mutation, PIK3CA gene amplification, and phosphatase and tensin homolog (PTEN) protein deficiency status by immunohistochemistry.|Baseline; 4 hours post-dose on C1D21|Baseline tumor tissue biomarker analysis set: all enrolled participants who started treatment, had baseline tumor tissues (archived paraffin block/unstained slides/fresh tumor tissue) analyzed for at least 1 of biomarkers. N (number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at specified time point.||participants|||Number
88189|NCT00927823|Secondary|Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21|Hair follicle biopsy samples analysis included assessment of status of proteins indicative of PI3K/mTOR related pathways signaling status and cell cycle status. The analytes measured were phosphorylated AKT S473, AKT T308, KI67, STAT3 (Y705) and proline-rich Akt substrate of 40 kilodaltons at Thr246 (PRAS40 T246). The method of analysis was reverse phase microarray (RPMA). The signal for each biomarker expressed as normalized fluorescence intensity (NFI) was normalized by their respective total protein concentration. This normalization was performed by dividing the biomarker NFI by total protein concentration (mg/mL) of the sample printed to give total protein normalized fluorescence unit (NFU). All clinical sample test results are reported in NFU.|Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21|Hair follicle analysis set included participants with hair follicles collected and analyzed for biomarkers at screening and on treatment. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.||NFU||Standard Deviation|Mean
88440|NCT00926211|Primary|Increase in Hair Follicles Present|The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.|Change from Baseline at 9 Months|The analysis was based on intention to treat (ITT). Imputation technique was based LOCF.||Hair follicles||Standard Deviation|Mean
88190|NCT00927823|Secondary|Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21|Fresh tumor biopsy samples analysis included assessment of status of proteins indicative of phosphoinositide 3-kinase/mammalian target of rapamycin (PI3K/mTOR) related pathways signaling status and cell cycle status. The biomarkers included phosphorylated activated kinase (AKT) S473, AKT T308, signal transducer and activator of transcription 3 (STAT3) and forkhead transcription factor Foxo1 (FKHR) T24/forkhead in rhabdomysacoma-like 1 (FKHRL1) T32. The method of analysis was reverse phase microarray (RPMA). The signal (normalized fluorescence unit [NFU]) for each pathway biomarker was normalized against the signal (NFU) for cytokeratin. The final concentration for each pathway biomarker was reported as a cytokeratin normalized fluorescence unit (NFC) value.|Baseline; 4 hours post-dose on C1D21|Fresh tumor biopsy analysis set included all enrolled participants in the tumor biopsy cohort who started treatment and had baseline and on-treatment fresh tumor tissue successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.||NFC||Standard Deviation|Mean
88191|NCT00927823|Secondary|Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum C-peptide level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively. Results of PF-04691502 2 mg and 4 mg arm not reported because none of the participants were evaluable.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
88192|NCT00927823|Secondary|Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum insulin level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively.||micro International Unit/mL (mc IU/mL)||Standard Deviation|Mean
88193|NCT00927823|Secondary|Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum glucose level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set included all enrolled participants who started treatment and had baseline and on-treatment serum biomarker samples (insulin, glucose, and c-peptide) successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point for each arm, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
88194|NCT00927823|Secondary|Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants had at least 1 ECG assessment after receiving PF-04691502.||participants|||Number
88195|NCT00927823|Secondary|Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving PF-04691502.||participants|||Number
88196|NCT00927823|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where tau is the dosing interval of 24 hours. It was evaluated following repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
88197|NCT00927823|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
88198|NCT00927823|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeat oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours (hrs) post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.||hours||Standard Deviation|Mean
88199|NCT00927823|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
88200|NCT00927823|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The PK of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.||hours||Full Range|Median
88201|NCT00927823|Secondary|Maximum Observed Plasma Concentration (Cmax)|The pharmacokinetics (PK) of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
88202|NCT00927823|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.||milligram|||Number
88203|NCT00927823|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells per cubic millimeter [cells/mm^3]) for 1 week or greater, febrile neutropenia (fever >=38.5 degree celsius with ANC <1000/mm^3), grade 3 (50,000 cells/mm^3) and grade 4 (<25,000 cells/mm^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for >14 days.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.||participants|||Number
88204|NCT00927823|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety analysis set included all enrolled participants who started the treatment.||participants|||Number
88205|NCT00927758|Primary|Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)|Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.|Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)|The per-protocol (PP) population was all subjects who completed the study with no major variances that would impair the analysis of the data||Percentage change in eNO||Standard Deviation|Mean
88206|NCT00927589|Primary|Minimum Observed Serum Trough Concentration (Cmin) of Trastuzumab||15 (±15) minutes prior to the start of the trastuzumab infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|PK analysis population for trastuzumab. n=participants with available data at each timepoint.||mcg/mL||95% Confidence Interval|Geometric Mean
88207|NCT00927589|Primary|Maximum Observed Serum Concentration (Cmax) of Trastuzumab||30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|The PK analysis population for trastuzumab included all participants who had at least 1 measurable serum trastuzumab concentration collected at a nominal sampling timepoint. Participants who did not receive a trastuzumab dose or for whom no trastuzumab PK samples were reported were excluded. n=participants with available data at each timepoint.||mcg/mL||95% Confidence Interval|Geometric Mean
88208|NCT00927589|Primary|Plasma Decay Half-Life (t1/2) of Carboplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin. n=participants with available data at each timepoint.||hr||Standard Deviation|Mean
88209|NCT00927589|Primary|Geometric Mean Ratio of AUC0-6hr/D of Carboplatin|The geometric mean ratio of AUC0-6hr/D of carboplatin was defined as the AUC0-6hr/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by AUC0-6hr/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||ratio||90% Confidence Interval|Geometric Mean
88210|NCT00927589|Primary|Dose−Normalized AUC0-6hr (AUC0-6hr/D) of Carboplatin|AUC0-6hr/D = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion, normalized by carboplatin dose level.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||(hr*mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
88211|NCT00927589|Primary|Geometric Mean Ratio of Cmax/D of Carboplatin|The geometric mean ratio of Cmax of carboplatin was defined as the Cmax/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by Cmax/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||ratio||90% Confidence Interval|Geometric Mean
88212|NCT00927589|Secondary|Population Pharmacokinetics of Trastuzumab|As per planned analysis, separate population pharmacokinetic analysis results are not available for the current study as this analysis is based on pooled data from multiple studies.|15 (±15) minutes prior to the start of the trastuzumab infusion, and 30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1||||||
88213|NCT00927589|Secondary|Number of Participants With Abnormal Changes in QRS Interval|Criteria for abnormal changes in QRS interval were defined as: >=25% change from baseline, an absolute value >110 msec, or >=25% change from baseline and an absolute value >110 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
88214|NCT00927589|Secondary|Number of Participants With Abnormal Changes in PR Interval|Criteria for abnormal changes in PR interval were defined as: =>25 percentage (%) change from baseline, an absolute value >200 msec, or >=25% change from baseline and an absolute value >200 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
88215|NCT00927589|Secondary|Number of Participants With New Abnormal T Waves on ECG|The incidence of abnormal T-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
88216|NCT00927589|Secondary|Number of Participants With New Abnormal U Waves on ECG|The incidence of abnormal U-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
88217|NCT00927589|Secondary|Number of Participants With Increase From Baseline in QTc Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of =>30msec, 30 to <60 msec (borderline) and >=60 msec (prolonged) were summarized.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
88218|NCT00927589|Secondary|Number of Participants Within Each Absolute QTc Interval Category|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum QTc less than or equal to (<=) 450 msec, greater than (>) 450 to <=470 msec, >470 to <= 500 msec, or >500 msec were reported.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||participants|||Number
88219|NCT00927589|Secondary|Baseline-adjusted Heart Rate|For each postbaseline timepoint, a participant’s corresponding baseline heart rate was subtracted from his or her average of the triplicate heart rate to create a “baseline-adjusted” corresponding heart rate for each participant at each postbaseline timepoint.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||beats per minute (bpm)||Standard Deviation|Mean
88220|NCT00927589|Secondary|Baseline-adjusted QTcF, QTcB, PR Interval, and QRS Duration|For each postbaseline timepoint, a participant’s corresponding baseline measure was subtracted from his or her average of the triplicate ECG measure to create a “baseline-adjusted” corresponding ECG measure for each participant at each postbaseline timepoint.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.||msec||Standard Deviation|Mean
89511|NCT00915148|Secondary|Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)||6 hours post determination of prolonged labor|||percentage of participants|||Number
88221|NCT00927589|Secondary|Change From Baseline in Corrected QT Interval Using Bazett’s Correction (QTcB) at Trastuzumab Steady State|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette’s formula (QTcB = QT divided by square root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 and Cycle 2 Day 1 after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population||msec||90% Confidence Interval|Mean
88222|NCT00927589|Primary|Dose-Normalized Cmax (Cmax/D) of Carboplatin|Dose normalized Cmax is the maximum observed concentration of carboplatin in plasma normalized for different dose levels.|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||(mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
88223|NCT00927589|Primary|Area Under the Curve From Time Zero to 6 Hours Post Infusion (AUC0-6hr) of Carboplatin|AUC0-6hr = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin||Hour*microgram/milliliter (hr*mcg/mL)||Standard Deviation|Mean
88224|NCT00927589|Primary|Maximum Observed Plasma Concentration (Cmax) of Carboplatin||0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The pharmacokinetic (PK) analysis population for carboplatin included all participants who had a measurable ultrafiltrate or plasma carboplatin concentration at all nominal sampling time points. Participants for whom a full set of carboplatin PK samples in both Cycle 1 and Cycle 2 was not reported were excluded.||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
88225|NCT00927589|Primary|Change From Baseline in Corrected QT Interval Using Fridericia’s Correction (QTcF) at Trastuzumab Steady State|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 (C1D8) and Cycle 2 Day 1 (C2D1) after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population: received any trastuzumab, had at least 1 interpretable baseline ECG measurement recorded on C1D2 prior trastuzumab exposure, had at least 1 interpretable ECG measurement recorded on C1D8 or C2D1 corresponding to time of steady-state trastuzumab concentration, and no infusion reaction requiring drug treatments.||milliseconds (msec)||90% Confidence Interval|Mean
88226|NCT00927576|Primary|Performance in TBI Patients and Controls|Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure.|Subjects were tested in a single 2-hr session.|Data from two TBI patients were excluded due to suspected suboptimal effort.||ms||Standard Deviation|Mean
88227|NCT00927563|Secondary|Gambling Symptom Assessment Scale (G-SAS)|Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score.|Visit 5 (final visit)|||units on a scale||Standard Deviation|Mean
88228|NCT00927563|Secondary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported.|Visit 5 (final visit)|||units on a scale||Standard Deviation|Mean
88229|NCT00927563|Primary|Clinical Global Impression Scale (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.|Visit 5 (final visit)|||units on a scale||Standard Deviation|Mean
88230|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)|"Treatment Success in the Modified ITT (non LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."||percentage of subjects|||Number
88231|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)|"Treatment Success in the Modified ITT (LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations was in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."||percentage of subjects|||Number
88232|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP|"Treatment Success in the PPP~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the PPP was considered supportive."|3 weeks|"The evaluations in the PPP was considered supportive The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 188; frequency missing = 33."||percentage of subjects|||Number
88233|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))|"Treatment Success in the Efficacy ITT (non LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|"Treatment Success was evaluated in the Efficacy ITT(non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13."||percentage of subjects|||Number
88234|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).|"Treatment Success in the Modified ITT (non-LOCF)~The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit.~Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified ITT (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.||percentage of subjects|||Number
88235|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)|"Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF)~The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified Intention to Treat ( Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.||percentage of subjects|||Number
88236|NCT00927472|Primary|Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment|"Treatment Success in the Per Protocol Population (PPP)~The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive."|3 weeks|The Per-Protocol Population (PPP) included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.||percentage of subjects|||Number
88237|NCT00927472|Primary|Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment|"Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF)~The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)."|3 weeks|Treatment Success in the Efficacy ITT (No LOCF) The Efficacy ITT population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.||percentage of subjects|||Number
88238|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))|"Treatment Success in the Efficacy ITT (LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|Treatment Success in the Efficacy ITT (LOCF). The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13.||percentage of subjects|||Number
88239|NCT00927472|Primary|Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.|"Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive.~The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).~Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))"|3 weeks|"The Efficacy Intention to Treat (eITT) population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.~eITT population: included all index subjects with at least one application of treatment.~Proportion of Subjects that are lice-free 14 days after their last treatment"||percentage of subjects|||Number
88240|NCT00927394|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|"Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.~Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards."|8 weeks|Safety Set — Consisted of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.||Patients|||Number
88241|NCT00927394|Secondary|Change From Baseline in Plasma Aldosterone at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||pmol/L||Standard Deviation|Mean
88242|NCT00927394|Secondary|Change From Baseline in Plasma Renin Concentration (PRC) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||ng/L||Standard Deviation|Mean
88243|NCT00927394|Secondary|Change From Baseline in Plasma Renin Activity (PRA) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||ng/mL/hr||Standard Deviation|Mean
88390|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult"|Day 14|||units on a scale||Standard Deviation|Mean
88244|NCT00927394|Secondary|Percentage of Responders|Responders were defined as patients with MSSBP <130 mmHg or a reduction from baseline in MSSBP of >20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.|Baseline, Week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.||Percentage of patients|||Number
88245|NCT00927394|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control was defined as MSSBP/MSDBP <140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported|8 weeks|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed.||Percentage of patients|||Number
88246|NCT00927394|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8|At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.|baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.||mmHg||Standard Deviation|Mean
88247|NCT00927394|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.||mmHg||Standard Deviation|Mean
88248|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8|The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.||mmHg||Standard Deviation|Mean
88249|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8|The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.||mmHg||Standard Deviation|Mean
88250|NCT00927394|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.||mmHg||Standard Deviation|Mean
88251|NCT00927394|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8|The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient’s available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.||mmHg||Standard Deviation|Mean
88252|NCT00927368|Secondary|Block Performance Time|Block performance time, block failure rate, number of sciatic nerve blocks, and cost of the femoral nerve blockade procedures|time elapsed from beginning the block to catheter placement|||seconds||95% Confidence Interval|Mean
88253|NCT00927368|Primary|Opioid Consumption|cumulative opioid consumption, where all opioids were converted to IV morphine equivalents|48 hours after surgery|||mg morphine equivalents||Inter-Quartile Range|Median
88254|NCT00927368|Primary|Time Weighted Average Verbal Response Scale Pain Score|"Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).~Verbal Response Scale (VRS) pain scores after surgery – which ranged from 0 (no pain) to 10 (maximum intolerable pain) – were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.) All"|48 hours after surgery|||verbal response scale||Standard Deviation|Mean
88255|NCT00927355|Secondary|Bone Mineral Density||6 months|||percent change from baseline to 6 months||Standard Error|Mean
88257|NCT00927355|Primary|Percent Change in Number of Osteoblast and Adipocyte Colony Forming Units Cultured From Bone Marrow Stem Cells Harvested 6 Months After Treatment With Study Drug Compared to Baseline|To determine the effect of PIO (pioglitazone) on BMSC (bone marrow stem cell) lineage choice in vivo, a bone marrow aspiration was obtained from patients at baseline and after 6 months of treatment with PIO or placebo. The bone marrow was used for ex vivo CFU-OB (Colony forming units-Osteoblast) and CFU-AD assays using the same protocol described for the in vitro studies previously. We also analyzed the number of total colonies per patient at both baseline and final visit.|6 months|||percent change from baseline to 6months||Standard Error|Mean
88258|NCT00927251|Primary|Number of Participants With Left Ventricular (LV)Lead Related Complications|A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.|Implant to one-month post implant|All subjects implanted with the lead who had completed their one-month post-implant/or a later follow-up visit, or have had a complication by the one-month post-implant visit, were included in the analysis. A complication is defined as an Adverse Event that results in death, any termination of significant device function or invasive intervention||participants|||Number
88259|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 12 Endpoint|OC is a measure of osteoblast function.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months OC measurements.||microgram/liter (µg/L)||Inter-Quartile Range|Median
88260|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 1, 3, and 6 Endpoint|OC is a measure of osteoblast function.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.||µg/L||Inter-Quartile Range|Median
88261|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 12 Endpoint|PINP is a measure of bone formation.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months PINP measurement.||microgram/liter (µg/L)||Inter-Quartile Range|Median
88262|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 1, 3 and 6 Endpoint|PINP is a measure of bone formation.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.||microgram/Liter (µg/L)||Inter-Quartile Range|Median
88263|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 12 Endpoint|CTX is a measure of bone resorption.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months CTX measurement.||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
88264|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 1, 3 and 6 Endpoint|CTX is a measure of bone resorption.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
88265|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Eroded surface/bone surface (ES/BS) in the endocortical compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the EC at 6 and 24 months.||percentage of surface||Inter-Quartile Range|Median
88266|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the CC at 24 months.||percentage of surface||Inter-Quartile Range|Median
88267|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of surface||Inter-Quartile Range|Median
88268|NCT00927186|Secondary|Wall Thickness (WTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Wall thickness (WTh.) in the endocortical compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the EC at 6 and 24 months.||micrometer (µm)||Inter-Quartile Range|Median
88269|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the CC at 24 months.||micrometer (µm)||Inter-Quartile Range|Median
88270|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||µm||Inter-Quartile Range|Median
88271|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid thickness (OTh.) in the endocortical compartment is a measure of the average thickness of osteoid seams.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the EC at 6 and 24 months.||micrometer (µm)||Inter-Quartile Range|Median
88272|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the CC at 24 months.||micrometer (µm)||Inter-Quartile Range|Median
88274|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid surface (OS) in the endocortical compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the EC at 6 and 24 months.||percentage of surface||Inter-Quartile Range|Median
88275|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the CC at 24 months.||percentage of surface||Inter-Quartile Range|Median
88276|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of surface||Inter-Quartile Range|Median
88277|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OV/BV analysis of the CC at 24 months.||percentage of volume||Inter-Quartile Range|Median
88278|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of volume||Inter-Quartile Range|Median
88279|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the endocortical compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the endocortical compartment at 6 and 24 months.||millimeter (mm)||Inter-Quartile Range|Median
88280|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the cancellous compartment at 24 months.||millimeter (mm)||Inter-Quartile Range|Median
88281|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||millimeter (mm)||Inter-Quartile Range|Median
88282|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the endocortical compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the endocortical compartment at 6 and 24 months.||samples|||Number
88283|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the cancellous compartment at 24 months.||samples|||Number
88293|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||year||Inter-Quartile Range|Median
88284|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||samples|||Number
88285|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the endocortical compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the endocortical compartment at 6 and 24 months.||percentage of tetracycline labels||Inter-Quartile Range|Median
88286|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the cancellous compartment at 24 months.||percentage of tetracycline labels||Inter-Quartile Range|Median
88287|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of tetracycline labels||Inter-Quartile Range|Median
88288|NCT00927186|Secondary|Active Formation Period (a.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|a. FP in EC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3 day-periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the EC at 6 and 24 months.||year||Inter-Quartile Range|Median
88289|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the CC at 24 months.||year||Inter-Quartile Range|Median
88290|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||year||Inter-Quartile Range|Median
88291|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Tt.FP in EC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the EC at 6 and 24 months.||year||Inter-Quartile Range|Median
88292|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the CC at 24 months.||year||Inter-Quartile Range|Median
88294|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Omt in EC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 Months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the EC at 6 and 24 months.||day||Inter-Quartile Range|Median
88295|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the CC at 24 months.||day||Inter-Quartile Range|Median
88296|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||day||Inter-Quartile Range|Median
88297|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Mlt in EC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the EC at 6 and 24 months.||day||Inter-Quartile Range|Median
88298|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the CC at 24 months.||day||Inter-Quartile Range|Median
88299|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as Osteoid Thickness (O.Th) divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||day||Inter-Quartile Range|Median
88300|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Aj.AR in EC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the EC at 6 and 24 months.||micrometer (µm)/day||Inter-Quartile Range|Median
88301|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the CC at 24 months.||micrometer (µm)/day||Inter-Quartile Range|Median
88302|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||µm/day||Inter-Quartile Range|Median
88303|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MAR in EC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the EC at 6 and 24 months.||micrometer (µm/day)||Inter-Quartile Range|Median
88304|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the CC at 24 months.||micrometer (µm)/day||Inter-Quartile Range|Median
88305|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive T labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||micrometer (µm)/day||Inter-Quartile Range|Median
88306|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|BFR in EC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of EC at 6 and 24 months.||mm³/mm²/year||Inter-Quartile Range|Median
88307|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of the CC at 24 months.||mm³/mm²/year||Inter-Quartile Range|Median
88308|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (cubic millimeter/square millimeter/year [mm³/mm²/year]); calculated as mineral apposition rate (MAR) times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||mm³/mm²/year||Inter-Quartile Range|Median
88309|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Ac.f in EC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the EC at 6 and 24 months.||new cycles/year||Inter-Quartile Range|Median
88310|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the CC at 24 months.||new cycles/year||Inter-Quartile Range|Median
88378|NCT00926393|Secondary|Number of Patients With Potential Extrapyramidal Symptoms (EPS)|Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness|From start of the study treatment to last dose plus 30 days|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||Patients|||Number
88311|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on BS (bone formation rate [BFR]/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 micrometer (µm)/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||new cycles/year||Inter-Quartile Range|Median
88312|NCT00927186|Secondary|Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MS/BS in EC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the EC at 6 and 24 months.||percentage of surface||Inter-Quartile Range|Median
88313|NCT00927186|Secondary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the CC at 24 months.||percentage of surface||Inter-Quartile Range|Median
88314|NCT00927186|Primary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.||percentage of surface||Inter-Quartile Range|Median
88315|NCT00927160|Secondary|Rehospitalization Rate|30 days for readmission rate|30 days|||percentage of particpants|||Number
88316|NCT00927160|Primary|Length of Hospital Stay||Depending on hospital stay|||days||Standard Deviation|Mean
88317|NCT00927095|Primary|Pre-Post Change in Premenstrual Symptom Severity|"Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: mean rating on the individual's worst symptom during the premenstrual week at baseline minus mean rating during the premenstrual week during the last on-treatment cycle. Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial."|monthly|||units on a scale||Standard Deviation|Mean
88318|NCT00927082|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche’s following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.||Participants|||Number
88319|NCT00927082|Secondary|Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)|Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.||Participants|||Number
88340|NCT00926952|Secondary|Mean Coarse Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of coarse wrinkles (i.e. deep lines, furrows, or creases). Coarse wrinkles appear on the forehead, glabella, chin, and nasolabial and periorbital areas, and they tend to be located closer to the eyes and mouth than fine wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
88320|NCT00927082|Secondary|Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B|Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.|Up to 5-year FU period|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Participants|||Number
88321|NCT00927082|Secondary|Quantitative HBsAg|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||log10 IU/mL||Standard Deviation|Mean
88322|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88323|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88324|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).|The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88325|NCT00927082|Primary|Percentage of Participants With HBsAg Loss|HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage||95% Confidence Interval|Number
88326|NCT00927082|Secondary|Percentage of Participants With Normalised Alanine Transaminase (ALT)|Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88327|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-HBs|The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88328|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).|The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88341|NCT00926952|Secondary|Mean Fine Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of superficial wrinkles (i.e. shallow indentations or lines). Fine wrinkles typically appear in periorbital and perioral regions and are usually found further from the eyes and mouth than are coarse wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
88329|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88330|NCT00927082|Secondary|Percentage of Participants With HBeAg Loss.|HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88331|NCT00927082|Primary|Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.|Annually, for up to 5 years|The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.||Percentage of participants||95% Confidence Interval|Number
88332|NCT00927069|Secondary|Total Number of Adverse Events for All Patients in the Study.|Safety of adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of therapy with etanercept|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Adverse events|||Number
88333|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at Week 24.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
88334|NCT00927069|Secondary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group B who achieve a Physician's global assessment (PGA) of clear or almost clear at Week 24.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
88335|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at week 12.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
88336|NCT00927069|Primary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)||Participants|||Number
88337|NCT00926952|Secondary|Number of Adverse Events|To study the safety of MAL-PDT performed without occlusion when red light exposure takes place 90 minutes after the application of MAL by tracking adverse events until week 12 and adverse events until week 24|12, 24 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Adverse events|||Number
88338|NCT00926952|Secondary|Mean Mottled Hyperpigmentation at Week 12|"This factor represents a visual assessment of light, patchy, mottled hyperpigmentation and solar freckling (including melasma) based on quantitative criteria such as the area/density of pigment, color intensity (dark vs. light), and uniformity of distribution (i.e. the more uneven or blotchy, the greater the score), Lentigines, nevi, and other pigmented lesions are not to be included in this assessment.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
88339|NCT00926952|Secondary|Mean Sallowness Score at Week 12|"This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
88342|NCT00926952|Secondary|Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12|Griffiths photonumeric scale was evaluated by the dermatologist. Patients were placed under natural daylight or fluorescent lighting for grading. A direct comparison was then made between the subjects and photographic standards (provided in reference 1). If an exact match could not be made to a grade then an inter-grade number was used used, for example 1, 3, 5, or 7. Zero (0) is the least amount of photodamage, 8 is the most amount of photodamage.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Units on a scale||Standard Deviation|Mean
88343|NCT00926952|Secondary|Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12||0, 12 weeks|||Lesions|||Number
88344|NCT00926952|Secondary|Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12|The proportion of patients with a complete clinical response is calculated by dividing the number of patients with a complete response at week 12 by the number of participants at baseline.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Participants|||Number
88345|NCT00926952|Primary|Mean Number of Facial Actinic Keratoses at Week 12||12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.||Lesions||Standard Deviation|Mean
88346|NCT00926887|Primary|Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'|24 hours|Intention to treat (ITT) analysis with imputation technique of Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
88347|NCT00926887|Secondary|Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale||7 days post surgery||||||
88348|NCT00926887|Secondary|Infection Evaluation||24 hours & 7 days post surgery||||||
88349|NCT00926887|Secondary|Hydration Level Assessment||immediately, 24 hours & 7 days post surgery.||||||
88350|NCT00926887|Secondary|Use of Pain Management Medication Post-surgically.|Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.|Through the 1st 7 post-operative days.|ITT with LOCF||medication doses||Standard Deviation|Mean
88351|NCT00926887|Secondary|Self-reported Degree of Pain Rating in the Breasts Area.||24 hours, 7 days, 14 days & 28 days post surgery||||||
88352|NCT00926887|Secondary|Swelling Evaluation Through Length by Width Breast Diameter Measurements||immediately, 24 hours & 7 days post surgery||||||
88353|NCT00926887|Primary|Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.|24 hours post-operative|ITT Analysis with LOCF technique employed, as applicable.||participants|||Number
88354|NCT00926796|Secondary|Number of Participants With Adverse Events for Each Regimen|Number of treated participants experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product.|Day 0 through Day 30|All participants receiving study medication comprised the safety population. Of 614 participants randomized, 603 received study medication.||participants|||Number
88355|NCT00926796|Primary|Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||percentage of participants|||Number
88356|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Enrollment Isolates.|Minimum inhibitory concentration (micrograms/milliliter) of pretreatment gonorrhea isolates collected from participants|Isolates obtained at enrollment (Day 0).|Per protocol population (all randomized participants who too study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.).||micrograms/milliliter||Full Range|Median
88357|NCT00926796|Secondary|Resolution of Symptoms and Signs (Clinical Cure)|Number of participants whose gonorrhea-related symptoms (e.g. vaginal/urethral discharge, dysuria, dyspareunia) present at enrollment has resolved by visit 2.|10-17 days after treatment.|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||participants|||Number
88358|NCT00926796|Secondary|Clinical Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), number participants with clinical symptoms (vaginal/urethral discharge, dysuria, dyspareunia) at 10-17 days.|10-17 days|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.||participants|||Number
88375|NCT00926497|Primary|Absolute Duration of Antibiotic Therapy|Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)|1 month|||hours||Full Range|Mean
88376|NCT00926497|Primary|Antibiotic Treatment for More Than 72 Hours|Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)|1 month|||participants|||Number
90641|NCT00904007|Secondary|Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only)||Months 1-12||||||
88359|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), the minimum inhibitory concentrations for various antimicrobial agents (Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Gemifloxacin, Gentamicin, Penicillin, Tetracycline).|Isolates obtained at enrollment (Day 0).|Participants in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.||micrograms/milliliter||Full Range|Median
88360|NCT00926796|Secondary|Eradication of Pharyngeal Infection|Number of enrollees with positive pharyngeal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for pharyngeal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||participants|||Number
88361|NCT00926796|Secondary|Eradication of Rectal Infection|Number of enrollees with positive rectal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for rectal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||participants|||Number
88362|NCT00926796|Primary|Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)||percentage of participants|||Number
88363|NCT00926783|Secondary|Incidence of Atrial Fibrillation (AF) Termination/Regularization|Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data||participants|||Number
88364|NCT00926783|Secondary|Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target|Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target|Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)|Per-protocol population with available outcome data||Milliseconds||Standard Deviation|Mean
88365|NCT00926783|Secondary|Fluoroscopy Time|"Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms.~Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis."|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data||Minutes||Standard Deviation|Mean
88366|NCT00926783|Secondary|Duration of Ablation Procedure|Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms.|Duration of ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data||Minutes||Standard Deviation|Mean
88367|NCT00926783|Primary|Total Radio-frequency (RF) Delivery Time During CFAE|Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|||Minutes||Standard Deviation|Mean
88368|NCT00926783|Primary|Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.|Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.|From day 91 to day 365 post first ablation procedure|Per-protocol population - subjects who underwent repeat ablation procedures within six months of initial procedures.||participants|||Number
88369|NCT00926588|Primary|Brief Pain Inventory (Pain)|The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain).|1 year|||units on a scale||Standard Deviation|Mean
88370|NCT00926575|Secondary|Survival Status||Day 200||||||
88371|NCT00926575|Secondary|Cumulative Exposure to Prednisone||Day 80||||||
88372|NCT00926575|Primary|The Proportion of Subjects With GVHD Treatment Failure|The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD|Day 80|Data was not analyzed as the study was terminated due to futility|||||
88373|NCT00926536|Primary|Cumulative Dose (CD), a Measure of Radiation Dose|CD - a measurement of total radiation to the skin (measure of a deterministic dose)|Duration of a TACE procedure, an average of 2 hours|CD measured in both groups||mGy||Full Range|Mean
88374|NCT00926536|Primary|Dose Area Product (DAP)|Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)|Duration of a TACE procedure, an average of 2 hours|DAP measured in both groups||Gy.cm2||Full Range|Mean
90642|NCT00904007|Secondary|Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)||Months 1-12||||||
88379|NCT00926393|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||units on scale||Standard Deviation|Mean
88380|NCT00926393|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||units on scale||Standard Deviation|Mean
88381|NCT00926393|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||units on scale||Standard Deviation|Mean
88382|NCT00926393|Secondary|Area Under the Modified Bond-Lader Visual Analog Scale-time Curve|Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose|During Day 2 (50 mg)|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.||mm * hour||Standard Error|Least Squares Mean
88383|NCT00926393|Secondary|Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||Hours||Standard Error|Least Squares Mean
88384|NCT00926393|Secondary|Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
88385|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 6 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
88386|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 5 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
88387|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 4 (200 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
88388|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 3 (100 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||Standard Error|Least Squares Mean
88389|NCT00926393|Primary|Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.||units on scale||95% Confidence Interval|Least Squares Mean
88391|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?~The subject replied using the following scale:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied"|Day 14|||units on a scale||Standard Deviation|Mean
88392|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult"|Day 14|||units on a scale||Standard Deviation|Mean
88393|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?~The subject replied using the following scale:~1 - Yes 0 - No"|Day 14|||units on a scale||Standard Deviation|Mean
88394|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?~The subject replied using the following scale:~0 - Not Compliant at all (<50%)~- Mostly Compliant (50%-79%)~- Very Compliant (80%-100%)"|Day 14|||units on a scale||Standard Deviation|Mean
88395|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?~The subject replied using the following scale:~- Very Comfortable~- Comfortable~- Somewhat Comfortable~- Somewhat Uncomfortable~- Uncomfortable"|Day 14|||units on a scale||Standard Deviation|Mean
88396|NCT00926367|Secondary|Self Assessment of Oiliness|"The amount of oiliness on the left and right cheek of each panelist.~The scale used to evaluate oiliness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88397|NCT00926367|Secondary|Self Assessment of Blistering|"The amount of blistering on the left and right cheek of each panelist.~The scale used to evaluate blistering is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88398|NCT00926367|Secondary|Self Assessment of Crusting|"The amount of crusting on the left and right cheek of each panelist.~The scale used to evaluate crusting is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88399|NCT00926367|Secondary|Self Assessment of Pain|"The amount of pain on the left and right cheek of each panelist.~The scale used to evaluate pain is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88400|NCT00926367|Secondary|Self Assessment of Texture (Roughness)|"The amount of roughness on the left and right cheek of each panelist.~The scale used to evaluate roughness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88401|NCT00926367|Secondary|Self Assessment of Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate dryness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88402|NCT00926367|Secondary|Self Assessment of Stinging|"The amount of stinging on the left and right cheek of each panelist.~The scale used to evaluate stinging is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88403|NCT00926367|Secondary|Self Assessment of Burning|"The amount of burning on the left and right cheek of each panelist.~The scale used to evaluate burning is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88404|NCT00926367|Secondary|Skin Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14|||Microsiemens||Standard Deviation|Mean
88405|NCT00926367|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14|||units on a scale||Standard Deviation|Mean
88422|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 3|The SBP value at baseline was subtracted from the SBP value at Week 3.|Baseline and Week 3|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
88406|NCT00926367|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss."|Baseline, Days 3, 7, and 14|||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
88407|NCT00926367|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|Baseline, Day 1 through Day 14|||Units on a scale||Standard Deviation|Mean
88408|NCT00926328|Primary|Plaque Index|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 Months|Per protocol||Units on a scale||Standard Deviation|Mean
88409|NCT00926328|Primary|Gingivitis Index|"Units on a scale 0 to 3 (0 = no inflammation ,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing.~3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|6 months|||Units on a scale||Standard Deviation|Mean
88410|NCT00926289|Secondary|BP Categories at Week 7|"BP categories comprise:~BP optimal (SBP <120 mmHg and DBP <80 mmHg)~BP normal (SBP <130 mmHg and DBP <85 mmHg but not ‘optimal’)~BP high normal (SBP <140 mmHg and DBP <90 mmHg but not ‘normal’)~Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not ‘high normal’)~Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not ‘Grade 1 hypertension’)~Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)"|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88411|NCT00926289|Secondary|Number of Participants With DBP Response at Week 7|DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88412|NCT00926289|Secondary|Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7|SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88413|NCT00926289|Secondary|Number of Patients With BP Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88414|NCT00926289|Secondary|Number of Patients With Blood Pressure (BP) Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88415|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3|DBP control is defined as DBP<90 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88416|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5|DBP control is defined as DBP<90 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||participants|||Number
88417|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7|DBP control is defined as DBP<90 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88418|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3|SBP control is defined as SBP < 140 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88419|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5|SBP control is defined as SBP < 140 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88420|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7|SBP control is defined as SBP < 140 mmHg.|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||Participants|||Number
88421|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7|The DBP value at baseline was subtracted from the DBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
88423|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 5|The SBP value at baseline was subtracted from the SBP value at Week 5.|Baseline and Week 5|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
88424|NCT00926289|Primary|Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7|The SBP value at baseline was subtracted from the SBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm||mmHg||Standard Error|Least Squares Mean
88425|NCT00926263|Secondary|Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples|Number of participants who tested positive for ADA|Day 1 pre-dose, Day 15, 29, 57, 85|All treated participants.||number of participants|||Number
88426|NCT00926263|Secondary|Serum Concentration of Fasting Glucose|Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||mg/dL||Standard Deviation|Mean
88427|NCT00926263|Secondary|Serum Concentration of Insulin|Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||mIU/mL||Standard Deviation|Mean
88428|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)|IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
88429|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 2 (IGF-2)|IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
88430|NCT00926263|Secondary|Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
88431|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.||ng/mL||Standard Deviation|Mean
88432|NCT00926263|Secondary|QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours||baseline, 3 hours postdose|Data not obtained due to early termination of the study.|||||
88433|NCT00926263|Primary|QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level|QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction|Day 1 at 1 and 24 hours post-dose, Day 7, 28|Data not obtained due to early termination of the study.|||||
88434|NCT00926263|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).||days||Standard Deviation|Mean
88435|NCT00926263|Primary|Apparent Volume of Distribution (Vz)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).||mL/kg||Standard Deviation|Mean
88436|NCT00926263|Primary|Plasma Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).||mL/day/kg||Standard Deviation|Mean
88437|NCT00926263|Primary|Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.||mg*h/L||Standard Deviation|Mean
88438|NCT00926263|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.||mg/L||Standard Deviation|Mean
88439|NCT00926211|Secondary|Proportion of Harvested Follicles Transected|The proportion of harvested hair follicles that were transected by each harvest method.|Time of harvest (Baseline)|||Proportion of transected follicles||Standard Deviation|Mean
88441|NCT00926029|Primary|Gingivitis Index|Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 Weeks|||Units on a scale||Standard Deviation|Mean
88442|NCT00926029|Primary|Plaque Index|Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks|||Units on a scale||Standard Deviation|Mean
88443|NCT00925990|Secondary|Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment|"Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented.~Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)"|Baseline and 24 weeks|All patients dosed with at least one dose of study drug were analyzed.||IU/mL||Standard Deviation|Mean
88444|NCT00925990|Primary|Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment|"Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood from before treatment (baseline) through 24 weeks of treatment.~Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)"|Baseline and 24 weeks|All patients receiving at least one dose of study drug were analyzed for safety.||log (IU/mL)||Standard Deviation|Mean
88445|NCT00925938|Secondary|Percentage of Participants With Adverse Events||9 days|||Percentage of participants|||Number
88446|NCT00925938|Secondary|Physician Assessment of Ease of Cervical Dilation;||18 - 24 hours|||percentage of participants|||Number
88447|NCT00925938|Secondary|Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;||18 - 24 hours|||minutes||Standard Deviation|Mean
88448|NCT00925938|Secondary|Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access||18 - 24 hours|A total of 46 subjects (90.2%) did not achieve their target dilatation after study drug removal (MVPI 400: 8 subjects; MVPI 800: 21 subjects; Placebo: 17 subjects). Forty-five subjects had additional dilatation attempted; additional dilatation was not attempted on one subject (MVPI 800) due to a protocol deviation (MVPI 800: 20 subjects).||percentage of participants|||Number
88449|NCT00925938|Primary|Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).||Baseline to 18-24 hours|||mm||Standard Deviation|Mean
88450|NCT00925782|Primary|Concentration-Max (Cmax)|"Cmax was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.~The Cmax results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate subsequent pharmacokinetic blood draws for the calculation of area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) for both Melphalan HCl for Injection and Alkeran for Injection.||ng/mL||Standard Deviation|Geometric Mean
88451|NCT00925782|Secondary|Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed.~Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.||days||Standard Deviation|Mean
88452|NCT00925782|Secondary|Determination of Myeloablation Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"ANC <0.5 × 109/L, absolute lymphocyte count (ALC) <0.1 × 109/L, platelet count <20,000/mm3, or bleeding requiring transfusion. The first of 2 consecutive days for which cell counts drop below these cutoff levels was recorded as the date of myeloablation.~Since the two treatments were administered consecutively with 1 day rest, the time to myeloablation and myeloablation rate was measured after both treatments were administered.~Comparison of sequence effect was not planned in the study and due to small sample size, it was not performed."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.||days||Standard Deviation|Mean
88453|NCT00925782|Primary|Area Under the Curve (0-t)|"AUC (0–t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.~The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|"The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection.~The results are presented by each drug group that combines data from both sequence."||min*ng/mL||Standard Deviation|Geometric Mean
88474|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
90643|NCT00904007|Secondary|Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)||Months 1-12||||||
88454|NCT00925769|Primary|Part 1: PRD of Bevacizumab for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/kg Q2W|||Number
88455|NCT00925769|Primary|Part 1: PRD of Erlotinib for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/day|||Number
88456|NCT00925769|Secondary|Part 2: Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|From baseline until death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
88457|NCT00925769|Secondary|Part 2: Percentage of Participants With Clinical Benefit Response|Clinical benefit response was defined as a composite of pain control, Karnofsky performance status (KPS), and weight. The KPS allows participants to be classified as per their functional impairment (abnormal function). It was recorded on an 11-point scale; 0= “dead” to 100= “Normal, no complaints, no evidence of disease” and sub-divided to 3 categories; 0 to 40 = “Unable to care for self, requires institutional or hospital care or equivalent, disease may be rapidly progressing”; 50 to 70= “Unable to work, able to live at home and care for most personal needs, varying amount of assistance needed and 80 to 100= “Able to carry on normal activity; no special care is needed”.|One week before start of study treatment and weekly until disease progression or death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
88458|NCT00925769|Secondary|Part 2: Percentage of Participants With Disease Control|A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) during the assessment. As per RECIST v1.1, CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|From baseline thereafter, every 6 weeks (±7 days), then 1 week after last dose (follow-up), thereafter every 6 weeks (±7 days) until disease progression (up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
88459|NCT00925769|Secondary|Part 2: Percentage of Participants Free From Disease Progression|As per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Month 6|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.|||||
88460|NCT00925769|Secondary|Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||h*µg/mL||Standard Deviation|Mean
88461|NCT00925769|Secondary|Part 1: Last Quantifiable Drug Concentration (Clast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||µg/mL||Standard Deviation|Mean
88462|NCT00925769|Secondary|Part 1: Time to Reach Cmax (Tmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||hours (h)||Full Range|Median
88475|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88463|NCT00925769|Primary|Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/m^2 BID|||Number
88464|NCT00925769|Primary|Part 1: MTD of Bevacizumab|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/kg once every 2 weeks (Q2W)|||Number
88465|NCT00925769|Secondary|Part 1: Maximum Serum Concentration (Cmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR] and 5'-Deoxy-5-Fluorouridine [5'-DFUR])||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
88466|NCT00925769|Primary|Part 1: MTD of Erlotinib|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/day|||Number
88467|NCT00925769|Primary|Part 1: Maximum Tolerated Dose (MTD) of Capecitabine|MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33 percent (%) of participants of the same quality category. DLT was defined as any greater than or equal to (>=) Grade (G) 3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to adverse events (AEs).|Up to Week 6 (Cycle 1-3)|Per-protocol population.||mg/m^2 BID|||Number
88468|NCT00925704|Secondary|Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set||hours||95% Confidence Interval|Median
88469|NCT00925704|Secondary|Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set||pg/ml||95% Confidence Interval|Least Squares Mean
88470|NCT00925704|Primary|Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|Pharmacokinetic set (PK) consists of subjects who received at least 1 dose of investigational product, had evaluable serum concentration-time profiles for calcitriol through 48 hours post-dosing on Day 1 of any treatment period and did not vomit between dosing and 10 hours post-dose on Day 1 of that treatment period.||pg*h/ml||95% Confidence Interval|Least Squares Mean
88471|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Evaluation Period|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88472|NCT00925587|Secondary|Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)||Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||Weeks||Inter-Quartile Range|Median
88473|NCT00925587|Secondary|Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88476|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88477|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88478|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88479|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88480|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88481|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88482|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88483|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88484|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88485|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88486|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88487|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88488|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||ratio||95% Confidence Interval|Geometric Mean
88489|NCT00925587|Secondary|Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 29-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88490|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88491|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88492|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88493|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88494|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88495|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88496|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88497|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88498|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88499|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88500|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88501|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88502|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88503|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
90644|NCT00904007|Secondary|Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)||Month 1||||||
88504|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88505|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 1|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 1|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||µg/wk||95% Confidence Interval|Geometric Mean
88506|NCT00925587|Secondary|Hb at Week 33||Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88507|NCT00925587|Secondary|Hb at Week 31||Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88508|NCT00925587|Secondary|Hb at Week 29||Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88509|NCT00925587|Secondary|Hb at Week 27||Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88510|NCT00925587|Secondary|Hb at Week 25||Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88511|NCT00925587|Secondary|Hb at Week 23||Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88512|NCT00925587|Secondary|Hb at Week 21||Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88513|NCT00925587|Secondary|Hb at Week 19||Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88514|NCT00925587|Secondary|Hb at Week 17||Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88515|NCT00925587|Secondary|Hb at Week 15||Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88516|NCT00925587|Secondary|Hb at Week 13||Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88517|NCT00925587|Secondary|Hb at Week 11||Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88518|NCT00925587|Secondary|Hb at Week 9||Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88519|NCT00925587|Secondary|Hb at Week 7||Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88520|NCT00925587|Secondary|Hb at Week 5||Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88521|NCT00925587|Secondary|Hb at Week 3||Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88522|NCT00925587|Secondary|Hb at Baseline||Baseline|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||Standard Error|Mean
88553|NCT00924833|Secondary|Systolic Pulmonary Artery Pressure.||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
88523|NCT00925587|Secondary|Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.||Baseline to Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||Percentage of Participants||95% Confidence Interval|Number
88524|NCT00925587|Primary|Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)|The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.|Baseline Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)||g/dL||95% Confidence Interval|Least Squares Mean
88525|NCT00925548|Secondary|Serum Carcinoma Antigen (CA) 15-3 Levels|CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.|Baseline, Week 5, 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88526|NCT00925548|Secondary|Number of Participant Utilizing Healthcare Resources|Healthcare Resource Utilization (HRU) parameters included direct medical resources (e.g., nonscheduled procedures, unplanned hospitalization, outpatient visits), nonmedical resources (e.g., travel, paid and unpaid assistance), and occupational resources (e.g., occupational changes and concerns).|Randomization up to end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88527|NCT00925548|Secondary|European Questionnaire-5 Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were to be converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00. Higher scores on the EQ-5D represent a better quality of life (QoL) and lower scores on the EQ-5D represent a worst QoL.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88528|NCT00925548|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire|FACT-B questionnaire consists of 36 questions; 7 in physical well-being (PWB); 7 in social well-being (SWB); 6 in emotional well-being (EWB); 7 in functional well-being (FWB); 9 in breast cancer subscale (BCS). Trial outcome Index (TOI) was calculated by the sum of the physical well-being (PWB), functional well-being (FWB), and breast cancer scale (BCS) subscales of FACT-B. Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88529|NCT00925548|Secondary|Time to Chemotherapy|Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.|Time from randomization to start of chemotherapy, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88530|NCT00925548|Secondary|Time to Progression (TTP)|TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).|Time from randomization to PD, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).|||||
88531|NCT00925548|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit is defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or stable disease (SD,) lasting for at least 22 weeks.|Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88532|NCT00925548|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88533|NCT00925548|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was to be reported. An objective response (OR) was defined as a participant having a best overall response of either confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST 1.0) as assessed by independent radiological review.|Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
88534|NCT00925548|Secondary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)|||||
90645|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure||Months 1-24||||||
88535|NCT00925548|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).|||||
88536|NCT00925522|Secondary|Chronic Success is Defined at 6 Months Following the RF Ablation Procedure as no Recurrence of Clinically Relevant VT(s) That Were Targeted at Ablation.||6 months||08/2016||||
88537|NCT00925522|Primary|Acute Success is Achieved When All Clinically Relevant VT Substrates (Spontaneous and Induced VT Episodes) Are Terminated and no Longer Inducible Upon Hospital Discharge (i.e., Last Study Ablation Procedure Prior to Hospital Discharge).||Hospital Discharge||08/2016||||
88538|NCT00925522|Primary|Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.||7 days|||participants|||Number
88539|NCT00925353|Secondary|Frequencies of Moderate, Severe, or Life-threatening Side Effects|Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after||||||
88540|NCT00925353|Secondary|Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.|Variation of heart rate (bpm), respiratory rate (respirations per minute, rpm), systolic blood pressure (mm Hg), and diastolic blood pressure (mm Hg) over time was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after||||||
88541|NCT00925353|Secondary|EKG Changes|The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.|Prior to gel application and 3 hours after||||||
88542|NCT00925353|Primary|Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.|Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.|Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after|Plasma lidocaine and MEGX levels were measured prior to lidociane gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after on 10 subjects (total of 80 lidocaine levels and 80 MEGX levels). Minimum level of detection for lidocaine and MEGX was 200 ng/mL.||nanograms/mililiter|Participants|Full Range|Median
88543|NCT00925288|Secondary|Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers|Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.|Month 0|All participants who listed doubts about the vaccine are counted here.||participants|||Number
88544|NCT00925288|Secondary|Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers|Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.|Baseline|All participants were included in the analysis for baseline HPV DNA prevalence||participants|||Number
88545|NCT00925288|Primary|Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.|Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.|6 months|All participants were included||participants|||Number
88546|NCT00925288|Primary|Antibody Response to HPV Vaccine for HPV 6,11,16,18.|We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.|Month 7|All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.||Milli Merck Units||95% Confidence Interval|Geometric Mean
88547|NCT00924950|Secondary|To Determine the Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion.||Between Week 4 and Week 6||||||
88548|NCT00924950|Primary|Difference in Change Between Baseline and Week 4 Modified Psoriasis Area Severity Index (PASI) Scores in Targeted Plaques Treated With Taclonex Under Occlusive Dressing Versus Taclonex Alone.|Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.|Between Baseline and Week 4|The number of participants was chosen by our budget restrictions||Units on a scale||95% Confidence Interval|Mean
88549|NCT00924833|Secondary|Mean 24 Hour/Daytime/Night-time Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
88550|NCT00924833|Secondary|Sitting Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
88551|NCT00924833|Secondary|Resting Energy Expenditure||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||12/2009||||
88552|NCT00924833|Primary|Delta Peak Exercise Minute Ventilation Time 1 Versus Time 3.|"Difference in peak exercise minute ventilation between Time 1 and Time 3 (Time 3 - Time 1.~Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)."|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||L/min||Standard Deviation|Mean
88555|NCT00924833|Primary|Peak Exercise Minute Ventilation|Minute ventilation at peak of exercise. Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||L/min||Standard Deviation|Mean
88556|NCT00924833|Primary|Delta Peak Exercise Oxygen Consumption Time 1 Versus Time 3|Difference in peak exercise oxygen consumption between Time 1 and Time 3 (Time 3 - Time 1)|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||ml/Kg/min||Standard Deviation|Mean
88557|NCT00924833|Primary|Peak Exercise Oxygen Consumption|Oxygen consumption at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.|||ml/Kg/min||Standard Deviation|Mean
88558|NCT00924807|Secondary|Biochemical Disease-free Survival|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|after 9 months||||||
88559|NCT00924807|Primary|Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|Day 29 and every 2 weeks|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|||||
88560|NCT00924781|Secondary|Change From Baseline in Hg Level at Week 12||12 weeks|Full analysis set; due to study termination participants in the MK2578 1mcg/350U QW and MK2578 1mcg/350U QM were not analyzed.||g/dL||Standard Deviation|Mean
88561|NCT00924781|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||12 weeks|Immunogenicity assays for antibodies to MK2578 were not performed due to early study termination.|||||
88562|NCT00924781|Primary|Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia||12 weeks|||Participants|||Number
88563|NCT00924781|Primary|Number of Participants With Composite Events of Infusion Reactions||12 weeks|||Participants|||Number
88564|NCT00924781|Primary|Number of Participants With Composite Events of Transfusion-Related Adverse Experiences||12 weeks|||Participants|||Number
88565|NCT00924781|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)||12 weeks|||Participants|||Number
88566|NCT00924781|Primary|Change From Baseline in Hemoglobin (Hg) Level at Week 4||4 weeks|Full analysis set||g/dL||Standard Deviation|Mean
88567|NCT00924729|Secondary|Disk Diffusion Assay of Collected Aqueous Humor|A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.|Approximately 3-4 months.||||||
88568|NCT00924729|Primary|Aqueous Humor Concentration of Study Drug|Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.|approximately 3 to 4 months|||µg/ml||Standard Deviation|Mean
88569|NCT00924638|Secondary|Impact of Patient Assistant Use on AF Diagnosis|AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency|Follow-up closure|Number of subjects in the Continuous Monitoring arm who had AF detected by the Insertable Cardiac Monitor (ICM) during the course of the study||days from AF occurrence to AF diagnosis||Standard Deviation|Mean
88570|NCT00924638|Secondary|Clinical Disease Burden and Care Pathway|Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months|12 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
88571|NCT00924638|Secondary|Health Outcome as Evaluated by EQ-5D Questionnaire|EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).|12 months|Number of subjects who reported EQ-5D VAS score at the 12 months visit||units on a scale of 0 to 100||Standard Deviation|Mean
88572|NCT00924638|Secondary|Use of Antiarrhythmic Drugs|Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12 months follow-up visit||percentage of participants|||Number
88573|NCT00924638|Secondary|Use of Oral Anticoagulation (OAC) Drugs|Percentage of subjects who were using OAC drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12-months follow-up visit||percentage of participants|||Number
88574|NCT00924638|Secondary|Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)|Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
88575|NCT00924638|Secondary|AF Detection Rate Within 12 Months|Percentage of subjects with AF detected within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
88576|NCT00924638|Primary|AF Detection Rate Within 6 Months|Percentage of subjects with AF detected within 6 months of follow-up|6 months|Intention-to-treat (ITT) population (all randomized subjects)||percentage of participants|||Number
88604|NCT00924443|Secondary|Overall Survival|Calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.||days||95% Confidence Interval|Median
88577|NCT00924560|Secondary|Number of Participants With Adverse Events (AEs)|"An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.~A severe AE is defined as incapacitating, with inability to perform usual activities.~A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:~fatal or life-threatening;~required or prolonged inpatient hospitalization;~resulted in persistent or significant disability/incapacity;~congenital anomaly or birth defect;~important medical event."|12 months|The safety analysis set includes data from all randomly assigned participants who received at least 1 dose of study treatment and from all participants enrolled in the control group who had baseline BMD measures via DXA. One participant randomly assigned to 91-day LNG received 21-day LNG instead and is included in the 21-day LNG group for safety.||participants|||Number
88578|NCT00924560|Secondary|Change From Baseline in Serum Type I Collagen N-telopeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||nM bone collagen equivalents (BCE)||Standard Deviation|Mean
88579|NCT00924560|Secondary|Change From Baseline in Serum Procollagen 1 N-terminal Propeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||µg/L||Standard Deviation|Mean
88580|NCT00924560|Secondary|Change From Baseline in Serum Osteocalcin||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||nmol/L||Standard Deviation|Mean
88581|NCT00924560|Secondary|Change From Baseline in Serum Deoxypyridinoline||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||nmol/L||Standard Deviation|Mean
88582|NCT00924560|Secondary|Change From Baseline in Bone-specific Alkaline Phosphatase||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."||µg/L||Standard Deviation|Mean
88583|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."||g||Standard Error|Least Squares Mean
88584|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."||g/cm^2||Standard Error|Least Squares Mean
88585|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."||g||Standard Error|Least Squares Mean
88586|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."||g/cm^2||Standard Error|Least Squares Mean
88587|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set||g||Standard Error|Least Squares Mean
88588|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set||g/cm^2||Standard Error|Least Squares Mean
88589|NCT00924560|Primary|Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)|"Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.~Percent change from Baseline was calculated as (BMD at Month 12 – BMD at Baseline)/BMD at Baseline * 100%."|Baseline and Month 12|Per-protocol analysis set, including all participants who received at least 1 dose of study treatment (does not apply to Control group), had both Baseline and one post-baseline assessment via DXA, and who completed all procedures at all scheduled study visits including the 12-month DXA scans, and did not have any major protocol violations.||percent change||Standard Error|Least Squares Mean
88590|NCT00924508|Secondary|Number of Adverse Events Associated With Treatment||6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.||Adverse events|||Number
88591|NCT00924508|Primary|Change in Disease Severity: Percent Change in Mean EASI Score|Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.|Baseline, 6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.||percentage change|Participants|Full Range|Mean
89851|NCT00911443|Secondary|Overall Survival|The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored.|2 years|||months||95% Confidence Interval|Median
88592|NCT00924482|Primary|Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements|"Correlation measured via Linear regression between thermodilution and ECOM, included as r^2 coefficient.~Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient.~ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely)."|perioperative period|Results are for the final n=101 who had the approved clinical electronics and clinical tube; no changes in tube, algorithm or electronic design were made during this part of the study. Experimental electronics and version of the tube were used to test and finalize the design and algorithm during enrollment of the earlier patient group.||liters/min||Standard Deviation|Mean
88593|NCT00924482|Secondary|Safety of Device Measured by Number of Participants With Adverse Events|Patients were interviewed postoperatively for all complications and specifically for complications related to intubation and/or cardiac output measurements|perioperative period|||participants|||Number
88594|NCT00924469|Primary|Dihydrotestosterone (DHT) Concentration in Prostate Tissue|The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Picogram per milligram (pg/mg)||Standard Deviation|Mean
88595|NCT00924469|Secondary|Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment|Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.|||||
88596|NCT00924469|Secondary|Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24|Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.|||||
88597|NCT00924469|Secondary|Percentage of Participants With Pathologic Complete Response (CR)|Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Percentage of participants|||Number
88598|NCT00924469|Secondary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.|Weeks 12 and 24|ITT population included all the participants who were randomly assigned to the study treatment.||Percentage of participants|||Number
88599|NCT00924469|Secondary|Serum Levels of Androgens|Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."||Nanogram per deciliter (ng/dL)||Standard Deviation|Mean
88600|NCT00924469|Secondary|Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue|Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."||Picogram per milligram (pg/mg)||Standard Deviation|Mean
88601|NCT00924469|Secondary|Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Picogram per milligram (pg/mg)||Standard Deviation|Mean
88602|NCT00924469|Primary|Testosterone Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Picogram per milligram (pg/mg)||Standard Deviation|Mean
88603|NCT00924443|Secondary|Duration of Complete Remission|Duration was calculated by Kaplan- Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only||days||95% Confidence Interval|Median
88605|NCT00924443|Secondary|Duration of Overall Response|Duration was calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only||days||95% Confidence Interval|Median
88606|NCT00924443|Secondary|Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)|"Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.~Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.||percent of participants||95% Confidence Interval|Number
88607|NCT00924443|Primary|Overall Response Rate (ORR)|"ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.~ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.||percentage of participants||95% Confidence Interval|Number
88608|NCT00924352|Primary|Evaluation of Progression-free Survival (PFS) of the Combination of Dasatinib and Ixabepilone (Phase II)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed about every 8 weeks) or death, whichever came first, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||months||95% Confidence Interval|Median
88609|NCT00924352|Secondary|Incidence of Grade 4 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||participants|||Number
88610|NCT00924352|Secondary|Incidence of Grade 3 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||participants|||Number
88611|NCT00924352|Secondary|Clinical Benefit Rate of the Combination of Dasatinib and Ixabepilone (Phase II)|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks (from the start of treatment) plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.|||percentage of participants|||Number
88612|NCT00924352|Secondary|Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.||participants|||Number
88613|NCT00924352|Primary|Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose limiting toxicity was defined as any grade 4 hematologic event or any grade 3 or 4 non-hematologic event occurring during cycle 1 that is attributable to dasatinib, ixabepilone, or the combination. The following events were excluded from this definition: grade 4 neutropenia lasting for 3 days or less; grade 3 nausea responsive to antiemetics; grade 3 infection with normal ANC or grade 1 or 2 neutrophils; grade 3 diarrhea responsive to optimal use of antidiarrheal therapy.|DLTs were assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.||participants|||Number
88635|NCT00924040|Secondary|Percentage of Patients Who Have Dose Limiting Toxicity (DLT)|Determination of dose limiting toxicity (DLT) is by the standard toxicity assessment Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3.0) done every cycle. For detailed information about the CTCAEv3.0 see the protocol Link module.|24 weeks|||Percentage of participants|||Number
88614|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I)|The MTD of ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) when given in combination with dasatinib (taken daily, continuously) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.||mg/m2|||Number
88615|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I)|The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.||mg daily|||Number
88616|NCT00924313|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years|||Participants|||Number
88617|NCT00924313|Primary|Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate|Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.|2 years|One patient was not imaged because of failed tracer synthesis.||ng/mL||Standard Deviation|Mean
88618|NCT00924287|Secondary|Number of Participants With In Vivo Survival of Transfused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|12 days|||Participants|||Number
88619|NCT00924287|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 days|||Participants|||Number
88620|NCT00924287|Primary|Number of Participants With an Objective Clinical Tumor Regression Response|Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 days||||||
88621|NCT00924209|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|38 months|||Participants|||Number
88622|NCT00924209|Primary|Rate of Pathologic Complete Response|Complete response is defined as a disappearance of all target lesions and was assessed by the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.|25 weeks|No goals were met because of low accrual for which the study was closed.|||||
88623|NCT00924066|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|61 months|Adverse events are grouped together because the histology cohort has no bearing on the adverse events.||participants|||Number
88624|NCT00924066|Primary|Tumor Response (PR + CR) Per RECIST|Establish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.|Every 6 weeks, up to 15 months|||participants|||Number
88625|NCT00924053|Primary|Vz/F|Apparent volume of distribution|3 days|||mL||Standard Deviation|Mean
88626|NCT00924053|Primary|CL/F|The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.|3 days|||mL/hr||Standard Deviation|Mean
88627|NCT00924053|Primary|t1/2|Apparent terminal half life|3 days|||hour||Standard Deviation|Mean
88628|NCT00924053|Primary|λz|Terminal phase rate constant|3 days|||1/hour||Standard Deviation|Mean
88629|NCT00924053|Primary|Tmax|Time of maximum plasma concentration|3 days|||hour||Full Range|Median
88630|NCT00924053|Primary|Cmax|Maximum plasma concentration|3 days|||ng/mL||Standard Deviation|Mean
88631|NCT00924053|Primary|AUC Inf|Area under the plasma concentration-time curve from time 0 to infinity|3 days|||ng*hr/mL||Standard Deviation|Mean
88632|NCT00924053|Primary|AUC0-24|Area under the plasma concentration-time curve from time 0 to hour 24|3 days|||ng*hr/mL||Standard Deviation|Mean
88633|NCT00924053|Primary|AUC 0-t|Area under the plasma concentration-time curve from time 0 to time t|3 days|||ng*hr/mL||Standard Deviation|Mean
88634|NCT00924053|Primary|Safety and Tolerability of EGT0001474|Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.|25 days|All patients who took study medication were included in the analysis.||Events|||Number
90646|NCT00904007|Secondary|Cross-cohort Comparison of Frequency of Treatment Intensification||Months 1-24||||||
88636|NCT00924040|Secondary|Percentage of Patients Who Make Antibodies|Determination of antibodies against BL22 is determined by the Clinical Laboratory Improvement Amendments (CLIA) certified blood tests in our contract lab. NCI-Frederick in the laboratory of Dr. David Waters (Science Applications International Corporation (SAIC). He is CLIA certified.|24 weeks|||Percentage of participants|||Number
88637|NCT00924040|Secondary|Correlation Between Number of Prior Cycles of BL22 With Immunogenicity on This Protocol|Percent of patients neutralizing >75% of 1000 ng/ml of BL22 in a biologic assay by end of treatment, with respect to the number of prior cycles of BL22 prior to entry on this protocol|Within 2 months of end of treatment ( measure antibodies before each cycle)|||correlation coefficient|||Number
88638|NCT00924040|Secondary|Percentage of Patients Who Respond Clinically, Who Also Have Normalization in sCD22 or sCD25|CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered <3 ng/ml for sCD25, and <2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.|patients may undergo lymphapheresis before the first and/or later cycles up to 12 months after achieving CR or PR|||Percentage of participants|||Number
88639|NCT00924040|Secondary|Number of Patients With ex Vivo Sensitivity Who Respond Clinically|Although some hairy cell leukemia (HCL) cells from some patients may have ex vivo sensitivity, they might not respond clinically. Number of participants with pretreatment ex vivo sensitivity (<10 ng/ml IC50) who go on to achieve CR as best response. CR required abscence of HCL in the bone marrow and resolution of cytopenias.|Time to CR can be between 2 months and 1 year|||Participants|||Number
88640|NCT00924040|Secondary|Number of Patients Who Developed Neutralizing Antibodies After One or More Cycles of BL22|Fresh malignant cells are isolated from blood, bone marrow, lymph nodes or other tissue and incubated with recombinant immunotoxins to determine sensitivity to BL22 and other agents to estimate the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.|24 weeks|||Participants|||Number
88641|NCT00924040|Secondary|Number of Participants With Complete Response (CR) Who Resolve the Bone Marrow Abnormality by Magnetic Resonance Imaging (MRI)|Patients are assessed by MRI to determine which ones resolve their marrow abnormality. A non-parametric Wilcoxon test was to be used to determine whether CR correlated with resolution of MRI abnormality|Bone marrow biopsy and MRI 4 weeks after patients meeting blood criteria for CR, and if CR is present, repeat bone marrow biopsy and MRI every 12 months. Bone marrow biopsy and MRI is not done in patients with PR as best response.|||Participants|||Number
88642|NCT00924040|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years & 6 months|||Participants|||Number
88643|NCT00924040|Primary|Number of Months to Response to Treatment|Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils >/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.|2/14/2009 till 6/24/2010|||Months|||Number
88644|NCT00924001|Secondary|Number of Participiants With In-vivo Survival of Infused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|44 days|||Participants|||Number
88645|NCT00924001|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|44 days|||Participants|||Number
88646|NCT00924001|Primary|Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progression (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|44 days|||Participants|||Number
88647|NCT00923975|Primary|Number of Participants Out of 50 Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks|"Study staff rated participants on their success at performing specific tasks. The rating scale was:~= Successful ( no assistance)~= Successful after staff prompted to view user instructions~= Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call)~= Unsuccessful (Subject could not perform the task)~= Subject could not perform task due to software or hardware failure after repeated attempt."|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.||participants|||Number
88648|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)|"Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale:~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.||participants|||Number
88649|NCT00923975|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)|"After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale.~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|The number of results analyzed was less than 50 because some subjects had no opinion. One subject had no opinion of clarity of online help overall and three subjects had no opinion of usefulness of online help overall.||participants|||Number
88650|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:~= Very Simple~= Simple~= Neither Simple nor Difficult~= Difficult~= Very Difficult"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.||participants|||Number
88651|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Serum Tumor Markers|C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
88652|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers|ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
88653|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers|Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
88654|NCT00923949|Secondary|Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)|Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
88655|NCT00923949|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|58 days|||Participants|||Number
88656|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor|Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
88657|NCT00923949|Primary|Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue|Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.|||||
88658|NCT00923910|Primary|Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3|Acute Graft versus Host Disease (GVHD) was graded by the modified Glucksberg scale. 0 = no GVHD normal, 4 = severe GVHD.|28 days following completion of last vaccine and/or DLI (donor lymphocyte infusion) administration|Data for the frequency and severity of GVHD was captured as an endpoint for this trial.||participants|||Number
88659|NCT00923910|Primary|Toxicity|Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module.|21 months|Recipients only experienced adverse events.||participants|||Number
88660|NCT00923845|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|50 months and 6 days|||participants|||Number
88661|NCT00923845|Primary|Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))|Response was assessed by computed tomography measurements and the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest LD recorded since the treatment started or the appearance of one or more new lesions.|6 Months Post-Transplant (Day +100)|||participants|||Number
88662|NCT00923481|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|23 months|||Participants|||Number
88663|NCT00923481|Primary|Response Rate|Response is assessed by the RECIST (response criteria in solid tumors)criteria. A complete response (CR) is disappearance of all target lesions , partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|24 months|||Participants|||Number
88664|NCT00923351|Primary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|At time of patients death||02/2018||||
88665|NCT00923351|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|49.5 months|||Participants|||Number
88688|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||pg/ml||Standard Deviation|Mean
88689|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||pg/ml||Standard Deviation|Mean
88666|NCT00923351|Primary|Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay|"A positive response to the tumor vaccine requires a positive reaction in at least one of the two assays below (immune responses to tumor lysates using ex vivo and delayed type of hypersensitivity (DTH).~The presence of a positive delayed type of hypersensitivity (DTH) reaction to the tumor lysate in a patient who did not show a positive DTH reaction prior to immunotherapy. A positive reaction is induration of at least 0.5 cm.~Immunotherapy administered to patients with recurrent or metastatic pediatric solid tumors such as Ewing's sarcoma, rhabdomyosarcoma, or neuroblastoma. Each vaccine is given as 6 separate injections. Three intradermal on one arm or leg and three subcutaneous on the other arm or leg."|Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (± 7 days) (Arm B)|Five of the original six participants from Arm A were analyzed because one subject was changed to a special exemption.||Participants|||Number
88667|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sirolimus|The phase I component of the study are to determine the safety and tolerability of sirolimus in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks|||mg/m^2|||Number
88668|NCT00923273|Primary|Phase II: Clinical Response Rate|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|21 weeks|By formal criteria in the protocol, DL4 exceeds the MTD, and DL 3 would be expanded by 3 subjects to confirm it's tolerability. We believe that DL4 is safe, and that the observed DLTs at this DL are related to enrollment of a subject with a borderline performance status, and the omission of defining length of neutropenia as a DLT.||Participants|||Number
88669|NCT00923273|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|45 months|||Participants|||Number
88670|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed|The phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks|||mg/m^2|||Number
88671|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||ng/ml||Standard Deviation|Mean
88672|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||ng/ml||Standard Deviation|Mean
88673|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||ng/ml||Standard Deviation|Mean
88674|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||ng/ml||Standard Deviation|Mean
88675|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||ng/ml||Standard Deviation|Mean
88676|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||ng/ml||Standard Deviation|Mean
88677|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||ng/ml||Standard Error|Mean
88678|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||ng/ml||Standard Deviation|Mean
88679|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||pg/ml||Standard Deviation|Mean
88680|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|6 months|||pg/ml||Standard Deviation|Mean
88681|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||pg/ml||Standard Deviation|Mean
88682|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal|||pg/ml||Standard Deviation|Mean
88683|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|1 year|||μg/mL||Standard Deviation|Mean
88684|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months|||μg/mL||Standard Deviation|Mean
88685|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months|||μg/mL||Standard Deviation|Mean
88686|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal|||μg/mL||Standard Deviation|Mean
88687|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year|||pg/ml||Standard Deviation|Mean
88736|NCT00923195|Primary|Complete Response Rates for Patients With Metastatic Melanoma|Complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is a disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|Every 4-6 weeks after initial treatment regimen. If the patient has stable disease or tumor shrinkage, complete evaluations will be repeated every 1-3 months.|||Participants|||Number
88737|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Terminal Elimination Half-life (T½)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hour||Standard Deviation|Mean
88738|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hr*ng/mL||Standard Deviation|Mean
88739|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hr*ng/mL||Standard Deviation|Mean
88740|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||hr*ng/mL||Standard Deviation|Mean
88741|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||ng/mL||Standard Deviation|Mean
88742|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.||Hour||Full Range|Median
88743|NCT00923156|Secondary|Biomarker Urinary Aldosterone After 12 Weeks of Treatment|24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose.|Baseline,12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.||ratio||95% Confidence Interval|Geometric Mean
88744|NCT00923156|Secondary|Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose.|Baseline, 12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.||ratio||95% Confidence Interval|Geometric Mean
88745|NCT00923156|Secondary|Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose.|Baseline,12 weeks (84 days, Period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."||ratio||95% Confidence Interval|Geometric Mean
88746|NCT00923156|Secondary|Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose.|Baseline, 12 weeks (84 days, period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.||ratio||95% Confidence Interval|Geometric Mean
88747|NCT00923156|Primary|Venous Angiotensin II Levels After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose.|Baseline. 12 Weeks (Day 84, period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."||ratio||95% Confidence Interval|Geometric Mean
88749|NCT00923117|Primary|6-month Progression-free Survival.|Time between the start of treatment to progression. Progression is defined by the RANO(Response Assessment in Neuro-Oncology) criteria. Progression is defined by any of the following: 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|63 patients enrolled with glioblastoma multiforme (GBM) (32 Bev naive, 31 Bev resistant) and were evaluated for this outcome measure.||Months||95% Confidence Interval|Median
88750|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.||Week 26 to week 54|The number of subjects up titrated who had blood pressure values at both time points.||mm Hg||Standard Deviation|Mean
88751|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 26|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V||Participants|||Number
88752|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.||mm Hg||Standard Error|Least Squares Mean
88753|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.||mm Hg||Standard Error|Least Squares Mean
88754|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV||Participants|||Number
88755|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one blood pressure measurement in Period IV||mm Hg||Standard Error|Least Squares Mean
88756|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV||mm Hg||Standard Error|Least Squares Mean
88757|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 10|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II||Participants|||Number
88758|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP).||Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II||mm Hg||Standard Error|Least Squares Mean
88759|NCT00923091|Primary|Change in Seated Diastolic Blood Pressure (SeDBP).|Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization|Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II||mm HG||Standard Error|Least Squares Mean
88760|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Co-morbidities|Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.|Baseline through week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.||participants|||Number
88761|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Drug Treatments|Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.|Baseline through Week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.||participants|||Number
88762|NCT00922987|Secondary|Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET|MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.|Baseline and week 16 or ET|The FAS included all participants who received at least 1 dose of the study drug and had at least one efficacy measurement.||Units on a scale||Standard Deviation|Mean
88763|NCT00922987|Secondary|Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit|"The CGI-C scale measures a physician’s global impression of a participant’s clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).~At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse."|Week 16 or ET|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.||Participants|||Number
88776|NCT00922766|Other Pre-specified|Number of Participants With Stroke|Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
88764|NCT00922987|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.||participants|||Number
88765|NCT00922987|Secondary|Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit|VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).|Baseline, week 4 and week 16 or ET|Full Analysis Set (FAS): Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. Analysis was done using LOCF method.||millimeter (mm)||95% Confidence Interval|Mean
88766|NCT00922987|Secondary|Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.|Week 4 through week 16 or ET|MFAS: Data collected during the titration phase, i.e. prior to Visit 2 (Week 4) were not analyzed for this endpoint. Only participants who did not discontinue in the first 4 weeks after the baseline visit (titration phase) and had at least 4 weeks of seizure data during the maintenance phase were analyzed for this endpoint.||Participants|||Number
88767|NCT00922987|Secondary|Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit|The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant’s final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.|Baseline and week 16 or ET|MFAS included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis. Analysis was done using last observation carried forward (LOCF) method.||percent change||95% Confidence Interval|Median
88768|NCT00922987|Primary|Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency|Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 – Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.|Baseline through week 16 or early termination (ET)|The modified full analysis set (MFAS) included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis.||Percentage of participants||95% Confidence Interval|Number
88769|NCT00922935|Primary|Bone Level Change on Radiographs|Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.|3 years after loading|||mm||Standard Deviation|Mean
88770|NCT00922779|Secondary|Percentage of Participants With Change in Hemoglobin Level|Change in hemoglobin level (compared to baseline) was reported as “significant decrease”, “Normal” (no change), “Increase”, “Decrease”, and “Missing”. Significant decrease was defined as per Investigator's discretion.|Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)|ITT Population.||Percentage of Participants|||Number
88771|NCT00922779|Secondary|Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation|HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48.|Weeks 12,24 and 48 After Therapy Initiation|ITT Population.||Percentage of Participants|||Number
88772|NCT00922779|Secondary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy|SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.|24 weeks after end of therapy (Week 72)|Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin.||Percentage of Participants|||Number
88773|NCT00922779|Primary|Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.|From signing of informed consent up to end of study (up to Week 72)|Safety analysis population included all participants who received at least one therapeutic dose of ribavirin.||Participants|||Number
88774|NCT00922766|Other Pre-specified|Number of Participants With Heparin Induced Thrombocytopenia|Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
88775|NCT00922766|Other Pre-specified|Number of Participants With Cardiac Arrest- Resuscitated|Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
88777|NCT00922766|Primary|Number of Participants With Minor Bleeding Events|Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
88778|NCT00922766|Primary|Number of Participants With Major Bleeding Events|Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
88779|NCT00922766|Primary|Number of Participants With Death or Myocardial Infarction (MI)||Baseline to 28 days after last dose of study drug|The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication.||Participants|||Number
88780|NCT00922701|Primary|Long Dwell Ultrafiltration|The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.|day 5|||milliliters||Standard Deviation|Mean
88781|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||Participants|||Number
88782|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||Participants|||Number
88783|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88784|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88785|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 in Stimulant Naive Methylphenidate Group|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88786|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
90647|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24)||Months 1-24||||||
88787|NCT00922636|Secondary|Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88788|NCT00922636|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88789|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.|||||
88790|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.|||||
88791|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88792|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88793|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88794|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88837|NCT00922428|Primary|Tenderness|Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
88795|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88796|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88797|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88798|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88799|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88800|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88801|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 in Stimulant Naive Methylphenidate Group|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88838|NCT00922428|Primary|Morning Stiffness|Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
88802|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88803|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88804|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88805|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88806|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88807|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. LS Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88839|NCT00922428|Primary|Pain on Weight-bearing|Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
89354|NCT00915798|Secondary|Salivary Cotinine|Average level of salivary cotinine over all time points (microgram/milliliter)|Once per week for 4 weeks|Discrepancies between participants cotinine samples and participant flow are due to the fact that not all participants provided useful saliva samples.||Microgram/milliliter||Standard Deviation|Mean
88808|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 in Stimulant Naive Methylphenidate Group|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88809|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88810|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group|76-item parent-rated assessment of child’s health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of ANCOVA model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88811|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8|76-item parent-rated assessment of child’s health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of covariance model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88812|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses adolescent’s health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least squares (LS) mean of the change from baseline to endpoint (week 8) is from an ANCOVA model. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline CHIP-AE domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88813|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8|Assesses adolescent’s health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least Squares (LS) Mean Change from analysis of covariance model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88814|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88840|NCT00922428|Primary|Pain After Rest|Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
88815|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88816|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at 8 Weeks in Stimulant Naive Methylphenidate Group|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88817|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at Week 8|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88818|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 in Stimulant Naive Methylphenidate Group|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||Participants|||Number
88819|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Intent to treat (ITT). All randomized participants with a baseline and at least 1 post-baseline C-SSRS assessment.||Participants|||Number
88820|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88821|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88841|NCT00922428|Primary|Pain in Movement|Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
88822|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88823|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88824|NCT00922636|Secondary|Change From Baseline in the CP-CBRS DSM-IV-TR ADHD Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88825|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88826|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) in Stimulant Naive Methylphenidate Group|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||Total Score||Standard Error|Least Squares Mean
88827|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8)|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Per protocol (PP) population included all randomized participants with a post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88828|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88842|NCT00922428|Primary|Pain at Rest|Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
90648|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24)||Months 1-24||||||
88829|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88830|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 in Stimulant Naive Methylphenidate Group|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88831|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||T-Score||Standard Error|Least Squares Mean
88832|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88833|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) participant population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.||units on a scale||Standard Error|Least Squares Mean
88834|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data might have been compromised.||units on a scale||Standard Error|Least Squares Mean
88835|NCT00922623|Primary|Percentage of Subjects With Product-related Adverse Events.|Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.|24 weeks|The Full Analysis Set (FAS) consisted of all subjects enrolled and treated with Belotero (ITT principle).||percentage of subjects with AEs.|||Number
88836|NCT00922428|Primary|Antalgic Position|Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value||percentage of participants|||Number
89355|NCT00915798|Secondary|DRD4 Genotype||one time blood draw|Discrepancies between participant flow and data analyze reflect that not all participants provided blood samples. Dopamine genotypes were only available for participants who were also enrolled in the Multimodal Treatment for ADHD Study (MTA-Study).||Participants|||Count of Participants
88843|NCT00922428|Secondary|Acceptance of the Drug|Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance.|from enrollment until completion|due to the character of an observational study: descriptive||percentage of participants|||Number
88844|NCT00922428|Primary|Tolerability of the Drug|"Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3).~It was measured by a score:~very well tolerated (no side effects)~moderately tolerated (mild side effects)~poorly tolerated (marked side effects)"|after end of study|1374 were full analysed, data of 2 patient were additionally analysed for tolerability||percentage of participants|||Number
88845|NCT00922428|Primary|Visual Analog Scale (VAS)|Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: all patient who had a value, descriptive||units on a scale||Standard Deviation|Mean
88846|NCT00922272|Secondary|Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 4 of Double-blind Phase|Randomized SAS defined as all subjects who took at least 1 dose of randomized investigational product and for whom at least 1 follow-up safety assessment was made.||Units on a scale||Standard Deviation|Mean
88847|NCT00922272|Secondary|Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 10 Open-label Phase|Safety Analysis Set (SAS) defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.||Units on a scale||Standard Deviation|Mean
88848|NCT00922272|Secondary|Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
88849|NCT00922272|Secondary|Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
88850|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
88851|NCT00922272|Secondary|Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Open-label Baseline and Week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
88852|NCT00922272|Secondary|Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
88853|NCT00922272|Secondary|Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
88854|NCT00922272|Secondary|Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS||Units on a scale||Standard Deviation|Mean
88855|NCT00922272|Secondary|Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 10 Open-label Phase|SAS||Units on a scale||Standard Deviation|Mean
88856|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS||T-scores||Standard Error|Least Squares Mean
88885|NCT00922207|Secondary|Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels|The normal range for ALT is 10 to 40 international units per liter (IU/L).|Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants|||Number
88857|NCT00922272|Secondary|Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS||T-scores||Standard Deviation|Mean
88858|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS||Scores on a scale||Standard Error|Least Squares Mean
88859|NCT00922272|Secondary|Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Open-label Baseline and week 10 Open-label Phase|FAS||Scores on a scale||Standard Deviation|Mean
88860|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Double-blind Randomization Baseline and week 4 Double-blind Phase|Randomized FAS||words recalled||Standard Error|Least Squares Mean
88861|NCT00922272|Secondary|Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Open-label Baseline and Week 10|FAS||words recalled||Standard Deviation|Mean
88862|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Double-blind Randomization Baseline and Week 4|Randomized FAS||correct sequences||Standard Error|Least Squares Mean
88863|NCT00922272|Secondary|Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Open-label Baseline and week 10 Open-label Phase|FAS||correct sequences||Standard Deviation|Mean
88864|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Double-blind Randomization Baseline and Week 4|Randomized FAS||correct numerals||Standard Error|Least Squares Mean
88865|NCT00922272|Secondary|Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Open-label Baseline and week 10 Open-label Phase|FAS||correct numerals||Standard Deviation|Mean
88866|NCT00922272|Secondary|Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Double-blind Phase Week 4|Randomized FAS||Percent of participants|||Number
88867|NCT00922272|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Open-label Phase Week 10|FAS||Percent of participants|||Number
88868|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 4 Double-blind Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 4 Double-blind Phase|Randomized FAS||Percent of participants|||Number
88869|NCT00922272|Secondary|Percent of Participants With CGI-S at Double-blind Randomization Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Double-blind Randomization Baseline|Randomized FAS||Percent of participants|||Number
88870|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 10 Open-label Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 10 Open-label Phase|FAS||Percent of participants|||Number
88871|NCT00922272|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Open-label Baseline|FAS||Percent of participants|||Number
88886|NCT00922207|Secondary|Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants|||Number
88872|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS defined as all subjects who received randomized investigational product and had a SANS-18 total scores at week 4 or at the early termination visit.||Units on a scale||Standard Error|Least Squares Mean
88873|NCT00922272|Secondary|Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS||Units on a scale||Standard Deviation|Mean
88874|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|RES||Units on a scale||Standard Error|Least Squares Mean
88875|NCT00922272|Secondary|Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS||Units on a scale||Standard Deviation|Mean
88876|NCT00922272|Secondary|Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.~The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 4 Double-blind Phase|RES||Percent of participants|||Number
88877|NCT00922272|Primary|Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized Evaluable Set (RES) defined as all randomized subjects who were responders (Response is defined as reduction in total SANS score of greater than or equal to 20%) at the Double-blind Randomization and had SANS-18 total scores at week 4 of the Double-blind Phase or the early termination visit.||Units on a scale||Standard Error|Least Squares Mean
88878|NCT00922272|Secondary|Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.~The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 10 Open-label Phase|FAS||Percent of participants|||Number
88879|NCT00922272|Primary|Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|Open-label Phase Full Analysis Set (FAS) defined as all enrolled subjects who took at least 1 dose of the investigational product and had 1 primary efficacy assessment after baseline in the Open-label Phase.||Units on a scale||Standard Deviation|Mean
88880|NCT00922233|Primary|Participant Report of Adverse Events.|Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken|6.5 months|A total of 58 women documented use of product on coital diaries and are included in the User Population for primary safety analysis. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.||adverse events|||Number
88881|NCT00922233|Secondary|Acceptability Based on Bleeding Patterns Reported|Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel|6.5 months|A total of 56 women reported on their bleeding patterns, of these, 43 found it acceptable. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.||participants|||Number
88882|NCT00922233|Primary|Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)|Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived|6.5 months|||pregnancies per 100 woman years|||Number
88883|NCT00922207|Secondary|Percentage of Participants With Combined Response|Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||percentage of participants|||Number
88884|NCT00922207|Secondary|Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||International Units/milliliter (IU/mL)||Standard Deviation|Mean
90649|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24)||Months 13-24||||||
88888|NCT00922207|Secondary|Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.||copies/mL||Standard Deviation|Mean
88889|NCT00922207|Primary|Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).|Week 100|ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
88890|NCT00922194|Primary|Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More|Change: Glycosylated Haemoglobin after 12 months or more of therapy - Glycosylated Haemoglobin at baseline.|Initial and at the end of 12 months or more|||Percentage of HbA1c||95% Confidence Interval|Median
88891|NCT00922194|Primary|Change in Fasting Blood Glucose From Baseline at 12 Months or More|Change: Fasting blood glucose after 12 months or more of therapy - Fasting blood glucose at baseline|Initial and at the end of 12 months or more|||mmol/L||95% Confidence Interval|Median
88892|NCT00922194|Primary|Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More|Change: Waist/Height ratio after 12 months or more of therapy - Waist/Height ratio at baseline|Initial and at the end of 12 months or more|||Ratio||95% Confidence Interval|Median
88893|NCT00922194|Primary|Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More|Change: Waist circumference/Hip circumference ratio after 12 months or more of therapy - Waist circumference/Hip circumference ratio at baseline|Initial and at the end of 12 months or more|||Ratio||95% Confidence Interval|Median
88894|NCT00922194|Primary|Change in Waist Circumference From Baseline at 12 Months or More|Change: Waist circumference after 12 months or more of therapy - Waist circumference at baseline|Initial and at the end of 12 months or more|||Centimeters||95% Confidence Interval|Median
88895|NCT00922194|Primary|Change in Body Mass Index (BMI) From Baseline at 12 Months or More|Change: Body Mass Index (BMI) after 12 months of therapy or more - BMI at baseline|Initial and at the end of 12 months or more|||kg/m2||95% Confidence Interval|Median
88896|NCT00922194|Primary|Change in Weight From Baseline at 12 Months or More|Change: Weight after 12 months of therapy or more - weight at baseline|Initial and at the end of 12 months or more|||Kg||95% Confidence Interval|Median
88897|NCT00922116|Secondary|Average Dose of Mircera Per Month||Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.||microgram (mcg)||Standard Deviation|Mean
88898|NCT00922116|Secondary|Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.||days||Standard Deviation|Mean
88899|NCT00922116|Secondary|Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population.||percentage of participants|||Number
88900|NCT00922116|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP|EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|ITT population.||percentage of participants||95% Confidence Interval|Number
88901|NCT00922116|Secondary|Change in Hemoglobin Concentration Between SVP and the EEP|Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.|SVP (Baseline), and EEP (Weeks 17 to 24)|ITT population.||grams per deciliter (g/dL)||Standard Deviation|Mean
88902|NCT00922116|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)|The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera.||percentage of participants||95% Confidence Interval|Number
88903|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)|Solicited local and general symptoms experienced within 14 days after vaccination 2|14 days after vaccination|||participants|||Number
88904|NCT00921947|Secondary|Anti-M2e Serum Antibody Concentration|Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.|42 days (+/- 2)|||Titers||95% Confidence Interval|Geometric Mean
88905|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)|Solicited local and general symptoms experienced within 7 days after vaccination 1.|0 to 7 days after vaccination|The population analyzed included all participants receiving at least 1 dose of the vaccine.||participants|||Number
88906|NCT00921934|Primary|Change of Pain Measured by VAS|VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS|visit 1 - 3|Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).||pain intensity||Standard Deviation|Mean
88907|NCT00921895|Primary|Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.|Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.|15 minutes|||percentage of cases||95% Confidence Interval|Number
88908|NCT00921687|Secondary|Last Clinic BP <130/80 mmHg|Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.|One year|||probability of controlled clinic BP||95% Confidence Interval|Number
88909|NCT00921687|Primary|PTH (Parathyroid Hormone) Adherence|Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.|One year|||probability of having a PTH measured|||Number
88910|NCT00921518|Primary|Number of Participants With Acute Kidney Injury|Acuge kidney injury is defined using the AKIN criteria|5 days|||participants|||Number
88911|NCT00921310|Secondary|Phase 2 Only: Phospho-S6 Levels in Circulating Mononuclear Cells Before and After Treatment||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
88912|NCT00921310|Secondary|Phase 2 Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
88913|NCT00921310|Secondary|Phase 2 Only: Survival Rate||1 year after start of treatment|||percentage of participants|||Number
88914|NCT00921310|Secondary|Phase 2 Only: Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression.|2 years from completion of treatment|There were only (2) patients evaluable for PFS.||days|||Number
88915|NCT00921310|Primary|Phase I Only: Phospho-S6 Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
88916|NCT00921310|Primary|Phase I Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.|||||
88917|NCT00921310|Primary|Phase I and Phase II: Overall Response Rate (Complete Response + Partial Response)|"Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.~Complete response (CR)−disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level.~Partial response (PR)−at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|2 years|(4) patients in Phase 1 were not evaluable for response as they were removed from study prior to week 6 scans. One patient in Phase 2 was not evaluable due to expiring prior to week 6 scans.||percentage of participants|||Number
88918|NCT00921310|Primary|Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLT) of Temsirolimus and Pemetrexed|"DLT will be defined as occurring within the first cycle of Phase I only and will be graded according to the Common Terminology Criteria for Adverse Events v 3.0 (CTCAE)~Any grade 3 or higher hematologic toxicity with the exception of anemia.~Any grade 3 or higher non-hematologic toxicity related to study therapy (except alopecia).~Grade 3 or 4 pneumonitis or esophagitis.~Treatment delay of temsirolimus for more than 14 consecutive days due to study-related toxicity.~Treatment delay of pemetrexed therapy for more than 14 consecutive days because of study-related toxicity."|Completion of first cycle (approximately 21 days)|||participants|||Number
88919|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Temsirolimus That Could be Administered Weekly in Combination With Pemetrexed|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study|||mg|||Number
88920|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Pemetrexed That Could be Administered Weekly in Combination With Temsirolimus|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study|||mg/m^2|||Number
88921|NCT00921024|Primary|Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|ME: Treated patients, with baseline pathogen, complied with protocol.||percentage of patients||95% Confidence Interval|Number
88922|NCT00921024|Primary|Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|mMITT: Treated patients, with baseline pathogen.||percentage of patients||95% Confidence Interval|Number
88931|NCT00920907|Secondary|Median Overall Survival Following First Ipilimumab Dose - All Treated Participants|Overall survival (OS) was defined as the time between the first dose of study treatment and death and was analyzed using Kaplan-Meier methods, with participants who had not died censored at the last date known to be alive. Overall survival was measured in months.|Week 1 (first dose) to last patient, last visit, approximately 3 years|All participants who received at least one dose of ipilimumab.||months||95% Confidence Interval|Median
90650|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24)||Months 13-24||||||
88923|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Electrolyte Laboratory Safety Tests - All Treated Participants|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN – 3.0; Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 – 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN – 11.5, Gr2:>11.5 – 12.5, Gr3: 12.5 – 13.5, Gr4: >13.5. Baseline is screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.||participants|||Number
88924|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Chemistry Laboratory Safety Tests (Non-electrolyte) - All Treated Participants|Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP); upper limits of normal (ULN). ALT Gr 1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 g/dL; Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*ULN; Gr 2: >1.5 – 3.0*ULN; Gr 3: >3.0– 6.0*ULN; Gr 4: >6.0*ULN. Lipase (U/L) Gr 1: 1.0 to 1.5*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.0 to 5; Gr 4: >5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Baseline was screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.||participants|||Number
88925|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Hematology Laboratory Safety Tests - All Treated Participants|Common Terminology Criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN); grams per deciliter (g/dL); Grade (GR); cells per microliter (c/µL). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute neutrophil (ANC) and ANC plus bands: Gr 1:<LLN to 1.5*10^3 c/µL, Gr 2:<1.5 to 1.0*10^3 c/µL, Gr 3:<1.0 to 0.5*10^3 c/µL, Gr 4:<0.5*10^3 c/µL. Platelet count Gr 1:LLN to 75.0*10^9 c/L, Gr 2:<75.0 to 50.0*10^9 c/L, Gr 3:<50.0 to 25.0*10^9 c/L, Gr 4:<25.0 to 10^9 c/L. Lymphocytes Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL. Baseline is screening or Day 1, prior to dosing.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.||participants|||Number
88926|NCT00920907|Secondary|Mean Change From Baseline in Sitting Pulse Rate - All Treated Participants up to Data Cutoff|Pulse Rate was measured in beats per minute (bpm) and was obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.||bpm||Standard Deviation|Mean
88927|NCT00920907|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants up to Data Cutoff|Systolic and Diastolic blood pressure were measured in millimeters of mercury (mmHg) and were obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.||mmHg||Standard Deviation|Mean
88928|NCT00920907|Secondary|Number of Participants Who Developed Antibodies and Neutralizing Antibodies|Electrochemiluminescent (ECL) Immunoassay was used to detect human anti-human ipilimumab antibodies (HAHA) in serum. Blood samples were collected prior to the start of each ipilimumab infusion at Weeks 1, 4, 7, 10, 24, and at end of treatment. Those participants who were positive HAHA on treatment were then tested for presence of neutralizing antibodies.|Prior to start of drug Week 1 to Week 24 on treatment or end of treatment|Participants who received study drug and had HAHA data prior to infusion in Week 1 and while on treatment.||participants|||Number
88929|NCT00920907|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Medical Dictionary for Regulatory Activities (MedDRA) version 15.1 was used. Note there is a difference in number of participants with an SAE in this outcome measure and the number listed in the Adverse Events Section of this document. This is because the SAEs reported in the xml upload of the Adverse Events section includes additional participants who reported SAEs after the clinical study report database was closed.|Day 1 to last patient, last visit, approximately 3 years|All participants who received at least 1 dose of ipilimumab.||participants|||Number
88930|NCT00920907|Secondary|Model Estimates of Mean Absolute Lymphocyte Count at Each Nominal Ipilimumab Induction Dose and at End of the Induction Dosing Period|Absolute lymphocyte counts (ALC) were obtained throughout the study as part of the hematology panel. Results collected from 28 days prior to the first infusion of ipilimumab through the end of the Induction-Dosing Period were included in the analyses of ALC. Mean ALC was estimated via an extended linear model, with linear splines and a spatial exponential within-patient correlation structure. Lymphocytes were measured as 1000 cells per micro liter (c/µL).|Day 0 (prior to first dose) to Day 84|All participants in the Pharmacodynamic data set with: (1) a baseline ALC evaluation; and (2) at least 1 post-baseline ALC evaluation (after the date of first dose).||1000 c/µL||95% Confidence Interval|Mean
88932|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Immune-related (ir) Response Criteria (RC) - All Randomized Participants|ir RC=modifications of mWHO criteria reflecting clinical experience with ipilimumab in over 20 completed and/or ongoing clinical studies. irRC were designed to capture clinical activity of ipilimumab immunotherapy that may not be adequately addressed by the mWHO criteria. irComplete Response (irCR): Complete disappearance of all index and non-index lesions. irPartial Response (irPR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index and all new measurable lesions in the absence of irCR, non-index lesions not considered. irStable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (irPD). irProgressive Disease (irPD): At least 25% increase in Tumor Burden when compared to sum of the products of diameters of lesions at nadir.|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions, and for irRC, no resection of new lesions.||participants|||Number
88933|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Modified World Health Organization (mWHO) Criteria - All Randomized Participants|Overall Response (OR) was determined as the combination of assessments of index and non-index lesions using mWHO criteria which were: Complete Response=complete disappearance of all lesions; Partial Response=decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease=does not meet criteria for complete or partial response, in the absence of progressive disease, or a decrease or tumor stabilization of one or more non-index lesions; Progressive Disease (Progression)=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s), or progression of non-index lesion(s). OR was measured across the entire study from Day 1 to the last patient, last visit (2009 to 2012)|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions.||participants|||Number
88934|NCT00920907|Secondary|Volume of Distribution at Steady State (Vss) of Ipilimumab Manufactured by Process C Relative to the Vss of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Vss was measured from first dose to end of the induction period (4 doses) in liter(s) (L). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||L||Geometric Coefficient of Variation|Geometric Mean
88935|NCT00920907|Primary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Day 21, AUC(0-21d), of Ipilimumab Manufactured by Process C Relative to the AUC(0-21d) of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. AUC(0-21d) was measured from first dose to end of the induction period as micrograms*hours per milliliter (μg*h/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
88936|NCT00920907|Secondary|Clearance (CLT) of Ipilimumab Manufactured by Process C Relative to the CLT of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. CLT was measured from first dose to end of the induction period (4 doses) in milliliters per hour (mL/h). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||mL/h||Geometric Coefficient of Variation|Geometric Mean
88946|NCT00920855|Secondary|Participants' Best Tumor Response as Assessed by the Investigator|Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and <5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for >=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by <100 mg, and disappearance of soft tissue plasmacytomas for >= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a >=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either >=90% or to <200 mg, and >=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a >=25% and <=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.|up to 7.5 months (eight 28-day cycles)|Efficacy population||participants|||Number
88937|NCT00920907|Secondary|Terminal Elimination Half Life (T-HALF) of Ipilimumab Manufactured by Process C Relative to the T-HALF of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. T-HALF was measured from first dose to end of the induction period (4 doses) in day(s). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||days||Standard Deviation|Mean
88938|NCT00920907|Secondary|Time of Maximum Observed Serum Concentration (Tmax) of Ipilimumab Manufactured by Process C Relative to the Tmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Tmax was measured from first dose to end of the induction period (4 doses) in hours (h). Samples were obtained at 0 h (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||h||Full Range|Median
88939|NCT00920907|Primary|Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|Single-dose Pharmacokinetic (PK) parameters of ipilimumab were derived from serum concentration versus time data. Cmax was measured from first dose to end of the induction period (4 doses) as micrograms per milliliter (μg/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|Pharmacokinetic (PK) evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
88940|NCT00920855|Secondary|Summary of Participants With Adverse Events (AEs)|Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.|up to 8.5 months. Deaths are reported up to 18 months|Safety population||participants|||Number
88941|NCT00920855|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Overall survival is defined as the time from initiation of therapy to death from any cause or last follow-up visit.|up to 23 months|Safety population||months||95% Confidence Interval|Median
88942|NCT00920855|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response (DR) is defined as the time from the first response to progressive disease (PD). See outcome #4 for a PD definition.|up to 8.5 months|Participants who had a response||months||95% Confidence Interval|Median
88943|NCT00920855|Secondary|Time to the First Response|Time to first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (ie, CR, VGPR, PR, or MR).|up to 8.5 months|Participants who had a response||months||Standard Deviation|Mean
88944|NCT00920855|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression free survival is the time between the date of initiation of therapy to progressive disease (PD) or death from any cause, whichever occurs first. See outcome #4 for a definition of PD.|up to 23 months|Safety population||months||95% Confidence Interval|Median
88945|NCT00920855|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP)|"Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following:~>25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L),~>25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h),~>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy (which must also be an absolute increase of at least 10%),~definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas,~the development of new bone lesions or soft tissue plasmacytomas,~the development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|up to 8.6 months|Safety population||months||95% Confidence Interval|Median
88947|NCT00920855|Secondary|Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator|Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.|Up to 7.5 months (eight 28-day cycles)|Efficacy population||percentage of participants||95% Confidence Interval|Number
88948|NCT00920855|Primary|Participants With Dose Limiting Toxicity (DLT)|"Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle:~grade 4 hematologic toxicity without regard for relationship to study drug treatment~thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage~grade 3 febrile neutropenia~grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy~any study drug related grade 3 or grade 4 nonhematologic toxicity~any drug related death~Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3."|Day 1 - 28|Safety population||participants|||Number
88949|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88950|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88951|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88952|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88953|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants|FKSI-DRS: subset of FKSI which is FACT–Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88954|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants|FKSI-DRS: subset of FKSI which is FACT–Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88973|NCT00920686|Secondary|2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|2 hours|Number of subjects with headache relief at 2 hours.||Participants|||Number
88955|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88956|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||units on a scale||Standard Deviation|Mean
88957|NCT00920816|Secondary|Overall Survival (OS): Second-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
88958|NCT00920816|Secondary|Overall Survival (OS): First-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
88959|NCT00920816|Secondary|Duration of Response (DR): Second-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
88960|NCT00920816|Secondary|Duration of Response (DR): First-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
88961|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): Second-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
88974|NCT00920686|Secondary|Headache Relief and Recurrence (Observed Cases)|"Headache relief is defined as a ≥ 1-point reduction from baseline in Headache Severity Score. The Headache Severity Score is a four-point scale: 0=no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain.~Headache recurrence is defined as any subject that experiences headache relief within 4 hours, who did not use rescue medication, and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration."|2, 4 and up to 24 hours|Number of subjects who experienced headache relief within 4 hours||percentage of participants|||Number
89550|NCT00914485|Primary|Change in Provider Use of Best Acts From Baseline to Post-Intervention|"Mean per-patient use of best acts learned during provider communication skills intervention, post-intervention minus baseline."|Baseline, 18 months|||best acts per patient||Standard Deviation|Mean
88962|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): First-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
88963|NCT00920816|Primary|Progression Free Survival (PFS): Second-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
88964|NCT00920816|Primary|Progression Free Survival (PFS): First-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|Full analysis set (FAS) included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
88965|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)||0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period).|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.||hours||Standard Deviation|Mean
88966|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)|Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.||ng·h/mL||Standard Deviation|Mean
88967|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|"Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.~The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose."|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.||ng/mL||Standard Deviation|Mean
88968|NCT00920790|Secondary|Overall Survival (OS)|The time from the date of first KW-0761 dosing to the date of death.|Baseline to response|Of the 27 subjects enrolled, 26 were included in the overall survival analysis set, whereas 1 was excluded.||days||Full Range|Median
88969|NCT00920790|Secondary|Progression Free Survival (PFS)|"The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death.~The antitumor response criteria including PD were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG)."|Baseline to response|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.||days||Full Range|Median
88970|NCT00920790|Primary|Overall Response Rate (ORR)|"Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response.~The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin’s lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR."|From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months.|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.||percentage of participants with response||95% Confidence Interval|Number
88971|NCT00920686|Secondary|24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|24 hours|Number of subjects with headache relief at 24 hours.||Participants|||Number
88972|NCT00920686|Secondary|4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|4 hours|Number of subjects with headache relief at 4 hours.||Participants|||Number
88975|NCT00920686|Primary|Time (Hours) to First Use of Rescue Medication||24 hours|The Full Analysis Set included all those subjects randomized who had dosed with study drug and had at least one (1) post study drug administration observation for headache severity. The Efficacy Evaluable Analysis Set, included all subjects with an imputed (LOCF) HSS at both the 2 hour time point and the 4 hour time point.||hours||Inter-Quartile Range|Median
88976|NCT00920647|Secondary|% Change From Baseline in Urinary GAG||Baseline to Week 27|||% Change||Standard Error|Mean
88977|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Repeated Doses of Intrathecal Idursulfase-IT Given in Conjunction With Elaprase||Weeks 23|Only 1 patient out of 4 in the 1mg dose yielded sufficient data to calculate AUC.||min*ng/mL||Standard Deviation|Mean
88978|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Single Administration (Week 3) in Conjunction With Elaprase|Values below lower limit of quantitation (LLOQ) are listed as 0.|Weeks 3|"Data were not available for the calculations in the patients of 1 mg idursulfase-IT group at Week 3.~Serum samples were not obtained from one patient in the 30mg Idursulfase-IT group at Week 3 after IV and IT administration."||min*ng/mL||Standard Deviation|Mean
88979|NCT00920647|Primary|Clinically Significant ECG Findings at Any Time During the Study.|Electrocardiogram (ECG) parameters included: heart rate, sinus rhythm, atrial/ventricular hypertrophy, PR, QRS, QT and QTc intervals.|6 months|Abnormalities Any Time Post-baseline ITT Population||participants|||Number
88980|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (Serum)||6 months|Development of antibodies post Baseline-ITT Population||participants|||Number
88981|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (CSF)|Reflects development of anti-idursulfase antibodies post baseline.|6 months|Abnormalities Any Time Post-baseline ITT Population||participants|||Number
88982|NCT00920647|Primary|Safety Changes in Cerebrospinal Fluid (CSF)- White Blood Cells (WBC)|White blood cell count in CSF was monitored throughout the study as a way of assessing any potential inflammation of the meninges induced by idursulfase-IT.|6 months|Abnormalities Any Time Post-baseline ITT Population||events|||Number
88983|NCT00920647|Primary|Number of Treatment Emergent Adverse Event (AE)|ITT patient population|Baseline to week 23|||events|||Number
88984|NCT00920647|Secondary|Level of Idursulfase in the CSF Compartment Resulting From Monthly Idursulfase IT Administrations|Samples collected from patients treated at doses of 1 mg and 30 mg, as well as the control group, were below the lower limit of detection of the bioanalytical method (3.13 ng/mL)|Week 27 (end of study)|||ng/mL||Standard Deviation|Mean
88985|NCT00920647|Secondary|Change From Baseline in CSF Glycosaminoglycans [GAGs] at Week 27|Percent Change from Baseline to Week 27|Baseline to Week 27|||% change||Standard Error|Mean
88986|NCT00920647|Primary|Number of Serious Adverse Event (SAE)||6 months|Abnormalities Any Time Post-baseline ITT Population||events|||Number
88987|NCT00920374|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period|||subjects|||Number
88988|NCT00920374|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
88989|NCT00920374|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||fold increase||95% Confidence Interval|Mean
88990|NCT00920374|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
88991|NCT00920374|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
88992|NCT00920374|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data||subjects|||Number
88993|NCT00920374|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
88994|NCT00920374|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
88995|NCT00920374|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
88996|NCT00920374|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data||titer||95% Confidence Interval|Geometric Mean
88997|NCT00920309|Secondary|Glomerular Filtration Rate (Kidney Function)||2 years|Outcome measures were not analyzed due to study termination|||||
88998|NCT00920309|Primary|Total Kidney Volume (mL)||2 years|Outcome Measures were not analyzed due to study termination|||||
88999|NCT00920231|Secondary|Ability to Meet the Subjective Travel Needs of the Blind Subject|This is a subjective rating that incorporates user friendliness of the system and the specific needs of the subject. The subject is asked to rate whether the device meets his or her travel needs on a 1 to 7 scale with 1 being excellent and 7 being very poor.|no time limit|||units on a scale||Standard Error|Mean
89000|NCT00920231|Primary|Frequency of Device Failures Per Attempt to Complete a Navigation Course|device failures were defined as any failure to provide correct location and direction information at thre appropriate time, resulting in a mistake that needed the initial prototype's ability to meet their travel needs at a good to excellent range.|The subject is given as much time as needed to complete the task|||number of device failures per attempt||Standard Error|Mean
89001|NCT00920140|Secondary|Overall Survival by Cohort|Overall survival is defined as the time from the start of study treatment (GSK1120212) until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who had not died at the time of analysis; such participants were considered censored.|From the start of the study drug until the final study visit (up to approximately 407 days )|Efficacy Population. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).||Months||90% Confidence Interval|Median
89002|NCT00920140|Secondary|Ctau of GSK1120212 in Part 2|Ctau is the pre-dose (trough) concentration at the end of the dosing interval and was measured for Cycle 1 Day 15 (C1D15), Cycle 2 Day 1(C2D1), Cylce 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), Cycle 7 Day 1 (C7D1), Cycle 8 Day 1 (C8D1), Cycle 9 Day 1 (C9D1), Cycle 10 Day 1 (C10D1), Cycle 11 Day 1 (C11D1) and Cycle 12 Day 1 (C12D1). Blood samples for PK analysis were collected pre-dose (i.e., no later than 15 min prior to dosing).|C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1 and C12D1|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
89003|NCT00920140|Secondary|Accumulation Ratio (AR) of GSK1120212 in Part 1|AR is the ratio of the Day 15 AUC0-tau (0 hour to last dose interval) and Day 1 AUC0-tau (AUCtau C1D15/AUCtau C1D1). Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||Ratio||Geometric Coefficient of Variation|Geometric Mean
89004|NCT00920140|Secondary|Tmax of GSK1120212 in Part 1|Tmax is defined as the time to reach the observed maximum concentration and was measured for C1D1 and C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||Hours||Full Range|Median
89005|NCT00920140|Secondary|t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half and was measured for C1D1. t1/2eff. is defined as the effective half-life and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff)|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||Hours||Geometric Coefficient of Variation|Geometric Mean
89006|NCT00920140|Secondary|Cmin and Cmax of GSK1120212 in Part 1|Cmax is defined as the maximum observed concentration of GSK1120212 and was measured for C1D1 and C1D15. Cmin is defined as the minimal observed concentration of GSK1120212 and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
89007|NCT00920140|Secondary|AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 24 hours (AUC[0-24]) for Cycle 1 Day 1 (C1D1), from time zero to the last time of a quantifiable concentration (AUC[0-t]) for C1D1 and Cylce 1 Day 15 (C1D15) and AUC curve over the dosing interval AUC[0-tau] for C1D15 were measured. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 minutes [min] before study drug administration) and at 0.5 hour (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population: all participants included in the All Treated Population for whom a PK sample was obtained and analyzed. Only participants with data available at the indicated time points were analyzed.||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
89008|NCT00920140|Primary|Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort|Overall response rate (ORR=CR+CRp+Marrow CR+MLFS+PR) was calculated from the investigator’s assessment of response recorded within the first eight weeks of treatment. CR includes complete remission. Complete remission is a state in which the participant must be free of all symptoms related to leukemia and have an absolute neutrophil count >=1 x 10^9/L, platelet count >=100 x 10^9/L, and normal marrow differential (<=5% blasts). PR includes partial remission. Partial remission is a state in which the participant has a CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. CRp is as per CR but platelet count <100 x 10^9/L. MLFS is a state in which the participant has a normal marrow differential (<5% blasts), neutrophil, and platelet counts are not considered.|From the start of the study drug until the final study visit (up to approximately 407 days)|Efficacy Population: all participants included in the All Treated Population who had received at least one dose of 2 mg of study drug in Phase 2. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).||Participants|||Number
89107|NCT00918736|Secondary|the Level of Global Satisfaction Based on a 7-point Categorical Scale|The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.|6 months||10/2009||||
89009|NCT00920140|Primary|Number of Participants With a Change From Baseline in Temperature by Dose|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants (par.) are counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
89010|NCT00920140|Primary|Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3/4 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3/4 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values are assumed to have a Baseline value of grade 0. Only those participants (par.) with blood pressure values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
89011|NCT00920140|Primary|Number of Participants With a Change From Baseline in Heart Rate by Dose|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants are counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-baseline. Only those participants (par.) with heart rate values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
89012|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose|Hematology and clinical chemistry data were summarized according to NCI-CTCAE grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, bicarbonate, potassium, magnesium, sodium, and phosphorus. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
89013|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, international normalized ratio (INR), lymphocytes, total neutrophils, platelet count, and partial thromboplastin time (PTT). Participants with missing baseline grades were assumed to have a baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy (defined as the worst shift that occurred at any time during the treatment period) are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
89014|NCT00920140|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose|An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.||Participants|||Number
89015|NCT00920075|Secondary|Number of Participants With Fracture|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.|Post study (1-6 years), one clinical visit|11 participants responded to participate in the post study. During their one clinic visit, their fracture history during the period before coming to the post study was obtained.||particilants|||Number
89016|NCT00920075|Secondary|Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.|Post study (1-6 years), one clincial visit|11 participants responded to participate in the post study. Their bone density of Hip was measured by DXA scan. Increase in percentage density of Hip was obtained from that of previous values. One participant showed a slight decrease in bone density.||participants|||Number
89017|NCT00920075|Primary|Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.|Post study (1-6 yrs), one clinical visit|Participants who earlier completed our phase I or phase II study on alendronate in juvenile osteoporosis, were invited to participate in the current post study evaluation of bone density and fractures.||participants|||Number
89018|NCT00919932|Secondary|Exit Interview|Verbal interview|1 month|||participants|||Number
89019|NCT00919932|Primary|Therapy Homework Compliance: Percent Homework Completed|Number of thought logs completed over the course of the 4 week trial.|1 month|||homework sheets completed||Standard Deviation|Mean
89020|NCT00919893|Primary|Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)|Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.|0, 6, 12 weeks|ITT (Intention to treat) LOCF (Last observation carried forward)||participants|||Number
89021|NCT00919893|Secondary|Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.|Decrease of score points. Decrease of leucocytes in urine.|0, 6, 12 weeks|||participants|||Number
89022|NCT00919867|Primary|T 1/2 of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
89023|NCT00919867|Primary|Tmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
89024|NCT00919867|Primary|AUC of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
89025|NCT00919867|Primary|Cmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng/ml||Standard Deviation|Mean
89026|NCT00919867|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
89027|NCT00919867|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
89028|NCT00919867|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
89029|NCT00919867|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-amphetamine. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
89030|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in CD4+ Percentage||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Percentage of lymphocytes||Standard Error|Mean
89031|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||log10 copies/mL||Standard Error|Mean
89032|NCT00919854|Secondary|Number of Participants With Less Than or Equal to 1 log10 Decrease in Plasma Viral Load at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
89033|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 400 Copies/mL) at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
89034|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 48||Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
89035|NCT00919854|Primary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR)|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 24|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.||Participants|||Number
89036|NCT00919763|Secondary|Percent Change in TSS||from Baseline to Week 4||||||
89037|NCT00919763|Primary|Total Sum Score (TSS)of Target Lesion|"Total Sum Score (TSS) on the Target Lesion at Week 4 or Early Termination adjusted on Baseline (Sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification of Target Lesion).~Scale values range from 0 - 3; 0 is minumal (best) and 3 is maximum (worst). Unit is used as score on a scale. Total possible minimum score is 0. Total possible maximum score is 15."|at Week 4|intention to treat (ITT) Last Observation Carried Forward (LOCF)||Scores on a scale||Standard Error|Least Squares Mean
89038|NCT00919724|Primary|Endothelial Function (Brachial Artery Reactivity)|The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.|Single measurement|||percent dilation||Standard Deviation|Mean
89039|NCT00919711|Secondary|Lumbar Spine BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation||Percent Change From Baseline||95% Confidence Interval|Mean
89040|NCT00919711|Secondary|Femoral Neck BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation||Percent Change From Baseline||95% Confidence Interval|Mean
89041|NCT00919711|Secondary|Serum CTX Percent Change From Baseline at Month 1|Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1|Baseline to month 1|All randomized subjects who enrolled in the bone marker substudy with observed data||Percent Change From Baseline||Inter-Quartile Range|Median
89042|NCT00919711|Primary|Total Hip BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation||Percent Change From Baseline||95% Confidence Interval|Mean
89043|NCT00919633|Secondary|Viral Decay||12 weeks of treatment||||||
89044|NCT00919633|Secondary|Functional Health, Depression Score, and Fatigue Level||through Study Week 72||||||
89045|NCT00919633|Secondary|Pharmacodynamics||through Study Week 72||||||
89046|NCT00919633|Secondary|Pharmacokinetics||through Study Week 72||||||
89047|NCT00919633|Secondary|End-of-treatment Response (EOT)||Study week 48||||||
89048|NCT00919633|Secondary|Early Virologic Response (EVR)||Study week 12|||participants|||Number
89049|NCT00919633|Secondary|Rapid Virologic Response (RVR)||Study Week 4|||participants|||Number
89050|NCT00919633|Primary|Safety/Tolerability||Through study week 72||||||
89051|NCT00919633|Primary|Viral Load: Incidence of Sustained Virologic Response (SVR)||24 weeks after treatment is complete|||participants|||Number
89052|NCT00919191|Secondary|Self Assessment of Burning/Stinging and Itching|Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe|Daily, for 3 weeks|||Scores on a Scale||Standard Deviation|Mean
89053|NCT00919191|Primary|Comparative Assessment of Facial Irritation and Cutaneous Effects.|Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe|Daily, for 3 weeks|All participants used both gels concurrently, on opposite sides of the face (split-face model)||Scores on a Scale||Standard Deviation|Mean
89054|NCT00919126|Secondary|Serum Chemistry - Urea (mmol/L)|Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||mmol/L||Standard Deviation|Mean
89055|NCT00919126|Secondary|Serum Chemistry - Creatinine (Mcmol/L)|Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||mcmol/L||Standard Deviation|Mean
89056|NCT00919126|Secondary|Serum Chemistry - Gamma GT (IU/L)|Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients)||IU/L||Standard Deviation|Mean
89057|NCT00919126|Secondary|Serum Chemistry - ALT (GPT) (IU/L)|ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||IU/L||Standard Deviation|Mean
89058|NCT00919126|Secondary|Serum Chemistry - AST (GOT) (IU/L)|AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||IU/L||Standard Deviation|Mean
89059|NCT00919126|Secondary|Haematology - Platelets (Giga/L)|Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||Giga/L||Standard Deviation|Mean
89060|NCT00919126|Secondary|Haematology - Erythrocytes (Tera/L)|Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day.|The analysis was done in the ITT Data Set (Randomised Patients).||Tera/L||Standard Deviation|Mean
89061|NCT00919126|Secondary|Haematology - Leucocytes (Giga/L)|Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||Giga/L||Standard Deviation|Mean
89062|NCT00919126|Secondary|Stay in the Recovery Room|Time interval between admission in the recovery room and discharge from the recovery room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
89063|NCT00919126|Secondary|Stay in the Operating Room|Time interval between admission in the operating room and discharge from the operating room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
89064|NCT00919126|Secondary|Awakening Time|Time interval between the end of maintenance period and time of Aldrete score ≥ 9.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
89065|NCT00919126|Secondary|Anaesthesia Recovery Time|Time interval between the end of maintenance period and time of tracheal tube removal.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).||minutes||Standard Deviation|Mean
89066|NCT00919126|Primary|Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)|Dose of propofol administered with a Target Controlled Infusion (TCI) device, cerebral concentration equal to 5 µg/mL at the end of induction, and then concentration adjusted to the level of depth of anaesthesia during maintenance. Depth of anaesthesia continuously assessed by signals derived from electroencephalographic recording. Analgesia during induction and maintenance obtained with remifentanil administered with a second TCI device at the stable cerebral concentration of 7 ng/mL.|Maintenance period (1 Day)|The main analysis was done in the ITT Data Set (Randomised Patients).||mg adjusted||Standard Deviation|Mean
89067|NCT00919113|Secondary|Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.|Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF|at week 11|Efficacy analysis performed according to randomized treatment.||participants|||Number
89068|NCT00919113|Primary|Global Response Assessment (GRA) Responders at Week 11.|"subjects that indicated markedly improved or moderately improved on the GRA, LOCF"|at week 11|Efficacy analysis performed according to randomized treatment.||participants|||Number
89069|NCT00919061|Primary|Median PFS|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 mos|||months||95% Confidence Interval|Median
89070|NCT00919061|Primary|Progression-Free Survival|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 months|||percentage of participants||95% Confidence Interval|Number
89071|NCT00919035|Secondary|Does the Prostate Specific Antigen (PSA) Doubling Times Change Before and After Treatment|PSA Doubling time is defined as the length of time that it takes for an individual patients PSA to double. PSA doubling times were calculated using the medial records at study entry for each patient. While the patient was on study their PSA doubling times were also calculated.|evaluate PSA doubling time pre study to actual doubling time while on study - calculated from start of study up to 10 cycles or 40 weeks.|PSA doubling time pre study was compared to PSA doubling time while the patients are on study, per protocol.||percentage of participants|||Number
89072|NCT00919035|Secondary|Time to Disease Progression|Time to disease progression is defined as the length of time from when the patient starts the study till disease progression. Disease progression is defined as more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Or the appearance of 2 or more new bony lesions on a bone scan. Or newly developed cord compression or pathologic fracture.|Disease progression is assessed every 2 months, for up to 40 weeks, measured from day one of protocol treatment until the date the patient is off study.|||months||Full Range|Mean
89073|NCT00919035|Primary|Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC).|The overall clinical benefit is defined as the sum of complete response (CR), partial response (PR), and stable disease (SD). CR: is the disappearance of all measurable lesions including bone lesions detected on the bone scan, no evidence of new lesions, and no disease-related symptoms. PR: More than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. SD: Lesions should have no sufficient decrease for PR or CR and no sufficient increase to meet criteria for Progressive Disease (PD). PD: > 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies OR The appearance of 2 or more new bony lesions on a bone scan is satisfactory for PD. Newly developed cord compression or pathologic fracture is defined as PD.|disease progression is assessed every 2 cycles, for up to 40weeks, per protocol, from the date of the first dose of study drug to the date the patient is taken off study|||percentage of participants|||Number
89074|NCT00918957|Primary|Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier|Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.||change in percentage||Standard Error|Least Squares Mean
89075|NCT00918957|Primary|Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)|"Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.~In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error.~﻿Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.||change in percentage||Standard Error|Least Squares Mean
89076|NCT00918957|Secondary|Tobramycin Serum Concentration|"Descriptive statistics of serum and sputum concentrations per scheduled sampling time.~Detectable concentration values at pre-dose on Day 1 were excluded from the analysis."|Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose|"Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.~This measures the concentration of active substance in the body at different time-point to evaluate there is abnormal accumulation of active substance. Not for Placebo Patients."||μ﻿g/mL||Standard Deviation|Mean
89108|NCT00918736|Secondary|Four Clinical Balance Tests|Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed “ Up-and-Go” test (TUG) ,Berg Balance Scale (BBS)|6 months||09/2009||||
89109|NCT00918736|Secondary|Ankle Sagittal Range of Motion|Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.|6 months||09/2009||||
90651|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12)||Months 1-12||||||
89077|NCT00918957|Secondary|Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug|"Relative change = 100 * (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose.~Day 1 is the scheduled visit of first study drug administration."|Day 1, Day 29|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received.||Percentage of participants|||Number
89078|NCT00918957|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|"Serious Adverse Events (on and off treatment) by preferred term and treatment group.~Preferred terms are sorted in descending order of frequency in the TIP treatment group.~A patient with multiple occurrences of the same preferred term is counted only once in the preferred term."|Time of consent, 4 weeks after study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.||percentage of participants|||Number
89079|NCT00918957|Secondary|Percentage of Participants With Adverse Events (AEs)|"Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group.~Primary system organ classes are sorted in descending order of frequency in the TIP treatment group.~A patient with more than one AE within a primary system organ class is counted only once for that class."|First administration of study drug, study completion|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received||Percentage of participants|||Number
89080|NCT00918957|Secondary|Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal|"Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline.~Biochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline."|Baseline, Study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.||percentage of participants at risk|||Number
89081|NCT00918957|Secondary|Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)|Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group.|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||μg/mL||Standard Deviation|Mean
89082|NCT00918957|Secondary|Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)|"P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).~If sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed."|Baseline, Day 29, Day 57|﻿Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Log10 CFU (colony forming unit)||Standard Error|Mean
89083|NCT00918957|Secondary|Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)|"﻿FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity~For FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value."|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||percentage change||Standard Error|Least Squares Mean
89084|NCT00918957|Secondary|Change From Baseline of ﻿Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)|"Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication.~Response (percentage change) = treatment + Screening FEV1 percentage predicted (<50 and >=50) + age (<13 and >=13) + error"|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||percentage change||Standard Error|Mean
89085|NCT00918957|Primary|Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)|"Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.~ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero.~BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication~- Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.||change in percentage||Standard Error|Least Squares Mean
89086|NCT00918931|Primary|Response Rate|Response rate is defined as number of participants with objective response divided by number of participants evaluated. Objective response is complete response and partial response where 'complete response' constitutes total elimination of a symptom or sign of the disease; 'partial response' constitutes at least 50% improvement in a symptom or sign of the disease. Objective response definitions of response evaluated following guidelines proposed by Valent et al. (International working group consensus criteria).|3-Month Response Evaluation|Analysis was per protocol.||participants|||Number
90094|NCT00909610|Primary|AUC0-72 for Baseline Corrected Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
89087|NCT00918879|Secondary|Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24|Proportion of participants (expressed in percentage of total participants)achieving HbA1c < 7.0% for saxagliptin versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||Percentage of Participants|||Number
89088|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mmol/L||Standard Error|Mean
89089|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
89090|NCT00918879|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in glycosylated haemoglobin A1c (HbA1c) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||percent||Standard Error|Mean
89091|NCT00918866|Secondary|Immunology Panel- Tryptase|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||ug/ml||Standard Deviation|Mean
89092|NCT00918866|Secondary|Immunology Panel- Interleuken-6|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||pg/ml||Standard Deviation|Mean
89093|NCT00918866|Secondary|Immunology Panel- Complement 5A(C5A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||ng/ml||Standard Deviation|Mean
89094|NCT00918866|Secondary|Immunology Panel- Complement 3A (C3A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes|||ng/ml||Standard Deviation|Mean
89095|NCT00918866|Primary|Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose|Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose|31-35 minutes minus baseline|Per the protocol||mm Hg||Standard Deviation|Mean
89096|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89097|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89098|NCT00918749|Secondary|Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|ITT Population|2 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89099|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89100|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89101|NCT00918749|Secondary|Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.|2 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89102|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population||3 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89103|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population||2 months|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89104|NCT00918749|Primary|Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population|Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.|Month 4|ITT Population||Percent Change from Baseline||Standard Error|Least Squares Mean
89105|NCT00918736|Secondary|Rescue Acetaminophen Consumption|The use of all analgesic medication during the study period was recorded on a diary card by the patient.|6 months||10/2009||||
89106|NCT00918736|Secondary|Systemic and Local Adverse Events Recording|he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card|6 months||10/2009||||
89110|NCT00918736|Secondary|The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score|The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment|6 months||10/2009||||
89111|NCT00918736|Primary|Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months|The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable|baseline and 6 months|The statistical analysis was done on completers.||score on a scale||Standard Deviation|Mean
89112|NCT00918671|Secondary|Change of Medication Days/Month Compared to Baseline||Baseline and after 4 years' of follow-up|||medication days/month||Standard Deviation|Mean
89113|NCT00918671|Primary|Change in Headache Days/Month After 4 Years Compared to Baseline|Change in headache days/month after 4 years compared to baseline|Baseline and after 4 years|||headache days/month||Standard Deviation|Mean
89114|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.||percentage of participants|||Number
89115|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius[C], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.||percentage of participants|||Number
89116|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (<2.5 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.||percentage of participants|||Number
89117|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than <2.5 centimeters [cm] for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than or equal to [>=] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here “Number of participants analyzed” signifies the safety population for Dose 1 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.||percentage of participants|||Number
89118|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||titer||95% Confidence Interval|Geometric Mean
90652|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12)||Months 1-12||||||
89119|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||titer||95% Confidence Interval|Geometric Mean
89120|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||mcg/mL||95% Confidence Interval|Geometric Mean
89121|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
89122|NCT00918580|Secondary|Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 – Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||ratio of GMFR||95% Confidence Interval|Geometric Mean
89123|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||fold rise||95% Confidence Interval|Geometric Mean
89136|NCT00918281|Secondary|The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.|Safety was monitored throughout the duration of the subject’s participation.|Up to 8 weeks post contrast administration.|The variable is looking at the Overall Summary of Treatment-Emergent Adverse Events (TEAE). Subjects could have experienced more than one TEAE. The category titles refer to Severe Adverse Events(SAE) and Adverse Events (AE).||number of adverse events|||Number
89137|NCT00918281|Primary|Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.|Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.|Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.|Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection).||Standardized Uptake Value||Standard Deviation|Mean
89124|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||fold rise||95% Confidence Interval|Geometric Mean
89125|NCT00918580|Primary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and “N” signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.|1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).||fold rise||95% Confidence Interval|Geometric Mean
89126|NCT00918385|Secondary|Overall Response Rate of Men With Low AR Activity|Tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During dasatinib monotherapy ( at least 12 weeks)|Of the 17 subjects treated, 15 had response documentation and are included in the calculation. Two were omitted (1 because response documentation was not provided; 1 ended treatment after 2 weeks for toxicity prior to repeat scans).||percentage of patients with CR,PR||95% Confidence Interval|Number
89127|NCT00918385|Secondary|Overall Response Rate of Men With High AR Activity|Tumor response was based on Response Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During monotherapy (at least 12 weeks)|14 subjects began treatment; 13 with response documentation are included in the calculation; 1 subject was omitted because response documentation was not provided.||percentage of patients with CR,PR||95% Confidence Interval|Number
89128|NCT00918385|Primary|Progression Free Survival (PFS)|PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first.|During monotherapy ( at least 12 weeks)|||months||90% Confidence Interval|Median
89129|NCT00918346|Primary|Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Per Protocol (PP): randomized patients who completed the study per protocol (i.e. excluded from PP is the discontinued patient and a patient with major protocol violation)||mmHg||95% Confidence Interval|Mean
89130|NCT00918346|Primary|Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Intention To Treat (ITT): randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.||mmHg||95% Confidence Interval|Mean
89131|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 4|IOPs at week 4: mean IOP values at four timepoints (worse eye)|Week 4|IOPs of all subjects who received preserved/unpreserved formulation||mmHg||Standard Deviation|Mean
89132|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 1|IOPs at week 1: mean IOP values at four timepoints (worse eye)|Week 1|IOPs of all subjects who received preserved/unpreserved formulation||mmHg||Standard Deviation|Mean
89133|NCT00918346|Secondary|Change From Baseline in Time-wise IOPs at Week 4|The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 4|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.||mmHg||95% Confidence Interval|Mean
89134|NCT00918346|Secondary|Overall and Time-wise Comparisons of IOP at Week 1|The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 1|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.||mmHg||95% Confidence Interval|Mean
89135|NCT00918346|Primary|Intraocular Pressures (IOPs) at Baseline|IOPs at baseline: mean IOP values at four timepoints (worse eye)|Baseline|IOPs of all subjects who received preserved/unpreserved formulation||mmHg||Standard Deviation|Mean
89138|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 52||||||
89139|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 52|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 52||||||
89140|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 16|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 16|Population was Intent-to-treat (ITT). Imputation method was Last Observation Carried Forward (LOCF).||scores on a scale||Inter-Quartile Range|Median
89141|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 12|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 12|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
89142|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 8|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
89143|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 4|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 4|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
89144|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 2|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 2|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
89145|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 16|Population was Intent-to-treat (ITT) and included participants with any inflammatory nodules (defined as tender, erythematous) or plaques at Baseline. Imputation method was Last Observation Carried Forward (LOCF).||percent change||Standard Error|Least Squares Mean
89146|NCT00918255|Primary|Percentage of Participants Achieving Clinical Response at Week 16|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 16|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).||percentage of participants|||Number
89147|NCT00918203|Secondary|PK - Steady State Volume of Distribution (Vss) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
89148|NCT00918203|Secondary|PK - Clearance (Cl) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hr, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
89149|NCT00918203|Secondary|PK - Half-Life (t1/2) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||days||Full Range|Geometric Mean
89150|NCT00918203|Secondary|PK - Maximum Concentration (Cmax) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
89151|NCT00918203|Secondary|Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab|AUC(0-168) = area under the concentration versus time curve from time zero to 168 hours post dose.|Cycle 3, Day 1: Predose, 30 minutes (min), 1.5 hours (hrs), 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
90095|NCT00909610|Primary|Cmax for Baseline Corrected Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
89152|NCT00918203|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline to Study Completion (Up to 8 Months)|All randomized participants who had baseline and post baseline Anti-Olaratumab antibodies. Those participants who did not meet eligibility criteria were not included in this assessment.||percentage of participants|||Number
89153|NCT00918203|Secondary|Pharmacodynamics of Olaratumab|Pharmacodynamics of Olaratumab was determined by analysis of pharmacodynamic markers vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF).|Cycle 1: Days 1, 8, and 15 pre- and post-infusion of Olaratumab; Cycles 2-6: day 1 only, pre- and post-infusion of Olaratumab|No data was available due to the collection of plasma samples was not fit for the assessment of PDGFs, as the collection procedure did not prevent platelet activation resulting in elevated levels of PDGFs in the circulation. Pharmacodynamics data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.|||||
89154|NCT00918203|Secondary|Median Duration of Response|The duration of overall response is measured from the time measurement criteria are first met for Complete Response (CR)/Partial Response (PR) (whichever is first recorded) until the first date that the criteria for PD are met (taking as a reference for PD the smallest measurement recorded since the treatment started), initiation of other/additional antitumor therapy is first reported, or death, is objectively documented.|First Criteria Met for CR or PR to Measured PD Start of Other Antitumor Therapy or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug and had achieved tumor response of CR or PR. Median Duration of Response data was not analyzed in the crossover olaratumab arm.||weeks||95% Confidence Interval|Median
89155|NCT00918203|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Baseline to Measured PD or Study Discontinuation (Up to 31 Months)|All randomized participants who received any dose of study drug.||percentage of participants||95% Confidence Interval|Number
89156|NCT00918203|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS was censored on the last date the participants is known to be alive.|Baseline to Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug. OS data was not analyzed in the crossover olaratumab arm. Participants censored: olaratumab + paclitaxel + carboplatin = 19 and paclitaxel + carboplatin = 20.||weeks||95% Confidence Interval|Median
89157|NCT00918203|Secondary|Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events||Up to 43 Months|All randomized participants who received any dose of study drug.||participants|||Number
89158|NCT00918203|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline to Study Completion (Up to 43 Months)|All randomized participants who received any dose of study drug.||participants|||Number
89159|NCT00918203|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression by RECIST version 1.1, or death from any cause. Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Baseline to Measured PD or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug. Participants censored: paclitaxel + carboplatin = 13, olaratumab + paclitaxel + carboplatin = 20, and crossover to olaratumab = 4.||weeks||95% Confidence Interval|Median
89160|NCT00918138|Other Pre-specified|Participants With Reported Hypoglycemic Adverse Events During Treatment Period|Hypoglycemic events are based upon the Saxagliptin Predefined List of Events, which includes hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. The Hypoglycemic events occurred in less than 5% of the participants and hence do not appear in the adverse events module.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.|||participants|||Number
89161|NCT00918138|Other Pre-specified|Participants With Confirmed Hypoglycemia Events During the Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick for glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.|Treated participants||participants|||Number
89162|NCT00918138|Secondary|Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal|FPG measurements were done at baseline, day 14 and 28. At baseline and day 28, the FPG value=plasma glucose value collected 30 minutes prior to the morning meal during the domicile visit.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments. Last Observation Carried Forward (LOCF).||mg/dL||Standard Error|Mean
89163|NCT00918138|Secondary|Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)|Adjusted mean change from baseline in 2-hour postprandial (after mealtime) plasma glucose two hours after start of the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.||mg/dL||Standard Error|Mean
89164|NCT00918138|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.||mg/dL||Standard Error|Mean
89165|NCT00918125|Other Pre-specified|Mean Knowledge Scores About ICD Therapy One Week Post Intervention.|We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.|one week post intervention|Mean scores were calculated with one point for each correct answer out of 13 questions for all patients with data.||units on a scale||Standard Deviation|Mean
89166|NCT00918125|Secondary|Receipt of an ICD|Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.|3 months|All patients with data at 3 months||participants|||Number
89167|NCT00918125|Secondary|Decisional Conflict Scale|At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict).|one week post intervention|Patients with data at one week||units on a scale||Standard Deviation|Mean
89168|NCT00918125|Primary|Decision to Receive an ICD|At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.|1 week post intervention|All patients with available data at one week||Participants|||Number
89169|NCT00917865|Secondary|Mean SUVmax of Low Versus High Gleason Groups|To determine id radiotracer uptake correlates with gleason score|4 minutes,16 minutes,28 minutes and 40 minutes|||Mean SUV max||Standard Deviation|Mean
89170|NCT00917865|Primary|Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis|"Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor.~Sensitivity: Proportion of people with a disease who have a positive test result~Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted.~Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted~Accuracy: Ability of the test to differentiate between disease and non-disease.~Note: 'n=' is the denominator used to compute each parameter."|At 4, 16, 28 and 40 minutes post-injection of FACBC|The number of participants for analysis was based on the protocol.Each prostate was divided into 12 sextants and then each sextant was visualized for abnormal focal uptake.The SUVmax for the malignant sextants were compared to that of the benign sextants. Note: 'n=' is the denominator used to compute each parameter.||Percentage of Sextants|Participants|95% Confidence Interval|Number
89171|NCT00917852|Primary|All Cause Mortality||30 days post-treatment|All enrolled subjects||participants|||Number
89172|NCT00917735|Primary|Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3|Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.|Baseline and month 12|Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12||ng/ml||95% Confidence Interval|Geometric Mean
89173|NCT00917735|Primary|Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)|Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.|Baseline and month 12|Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12||pg/ml||95% Confidence Interval|Geometric Mean
89174|NCT00917735|Primary|Mammographic Density|Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.|Baseline and month 12|Mammographic density at baseline and month 12||Percent||95% Confidence Interval|Geometric Mean
89175|NCT00917644|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; ln 2/kel, where kel is the termination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||hours||Standard Deviation|Mean
89176|NCT00917644|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL); collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||ng/mL||Standard Deviation|Mean
89177|NCT00917644|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast). PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||ng*hr/mL||Standard Deviation|Mean
89178|NCT00917644|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence; PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population||hours||Full Range|Median
89179|NCT00917644|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng*hr/mL). Pharmacokinetic (PK) parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population defined as all subjects randomized and treated who had > = 1 of the parameters of primary interest in > = 1 treatment period.||ng*hr/mL||Standard Deviation|Mean
89180|NCT00917579|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||hours||Standard Deviation|Mean
89181|NCT00917579|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||hours||Inter-Quartile Range|Median
89182|NCT00917579|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||ng/mL||Standard Deviation|Mean
89183|NCT00917579|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.||ng•hr/mL||Standard Deviation|Mean
89184|NCT00917579|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|Pharmacokinetic (PK) parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, except 1 time point.||ng•hr/mL||Standard Deviation|Mean
89185|NCT00917501|Primary|Change From Baseline in Depression Symptom Severity at 12 Weeks|Change in Children’s Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)|Baseline and 12 weeks|||Total score on CDRS-R||Standard Deviation|Mean
89186|NCT00917384|Secondary|Number of Participants Who Developed Antibodies Against IMC-1121B|The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.|Baseline, 12 Weeks|Subset of the Safety Population: All randomized participants who received at least 1 dose of study drug and who had immunogenicity analysis performed.||participants|||Number
89187|NCT00917384|Secondary|Maximum Concentration (Cmax) of IMC-1121B|Cmax was not analyzed as only pre-dose samples were collected.|6 weeks post-randomization|Zero participants were analyzed.|||||
89188|NCT00917384|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.|Randomization up to 18 months|Safety Population: All randomized participants who received at least 1 dose of study drug.||participants|||Number
89189|NCT00917384|Secondary|Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.|Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])|All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.||units on a scale||Standard Error|Least Squares Mean
89203|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||percentage of patients|||Number
89190|NCT00917384|Secondary|Duration of Response (DOR)|DOR is the interval from date of initial documented response (complete response [CR] or partial response [PR]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.|Randomization up to 17 months post-randomization|Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.|||||
89191|NCT00917384|Secondary|Percentage of Participants With Objective Response (Objective Response Rate [ORR])|ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.|Randomization up to 17 months post-randomization|Intent-to-treat population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
89192|NCT00917384|Secondary|Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)|The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.|Week 12 post-randomization|Intent-to-treat population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
89193|NCT00917384|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).|Randomization up to 17 months|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.||months||95% Confidence Interval|Median
89194|NCT00917384|Primary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive|Randomization up to 28 months post-randomization|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.||months||95% Confidence Interval|Median
89195|NCT00917267|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.||events per subject-year||Standard Error|Mean
89196|NCT00917267|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was not imputed.||mmHg||Standard Deviation|Mean
89197|NCT00917267|Secondary|Ratio of Triglycerides (TG) at Week 26 to Baseline|Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||ratio||Standard Error|Least Squares Mean
89198|NCT00917267|Secondary|Change in High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in HDL from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mg/dL||Standard Error|Least Squares Mean
89199|NCT00917267|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 26|Change in TC from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mg/dL||Standard Error|Least Squares Mean
89200|NCT00917267|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||kg||Standard Error|Least Squares Mean
89201|NCT00917267|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mg/dL||Standard Error|Least Squares Mean
89202|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.||percentage of patients|||Number
89204|NCT00917267|Primary|Change in HbA1c From Baseline to Week 26.|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|ITT Population: Randomized patients received at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of total hemoglobin||Standard Error|Least Squares Mean
89205|NCT00917124|Secondary|Evidence of Coma, Stupor, Cerebral Insult, Delirium, Ventilation Longer Than 24 Hours, Myocardial Infarction, Atrial Fibrillation, Dialysis, Reoperation for Bleeding, Infection, Hospital Stay > 7 Days||7 postoperative days|||participants|||Number
89206|NCT00917124|Primary|Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.|"The Mini-Mental State Examination (MMSE) total score is calculated by summing the item scores across several aspects of cognition. The maximum possible total score is 30 points.~Color Trials Test (CTT) measures sustained visual attention, visual scanning and graphomotor skills. The examiner records the length of time (in seconds) required by the patient to rapidly draw a line connecting the circles numbered 1 through 25 in consecutive order.~Grooved-Pegboard test (GP test) is manipulative dexterity test that contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted. The examiner records the time in seconds.~Cognitive impairment was defined as a decline in postoperative performance in one or more tests: decrease of MMSE score three points or more from baseline and decrease of one standard deviation or more in performance on CTT 1 and GP tests"|preoperative, 7 days postoperative|"3 participants in Control group did not perform control cognitive test- transferred to another hospital.~6 participants in INVOS group did not perform control cognitive test - transferred to another hospital n=4, declined to participate n=2"||participants|||Number
89207|NCT00916929|Secondary|Sensitivity|Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).|6-months|All patients enrolled in the study were included in this analysis with a total of 82 patients in each group. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D during data collection period. These 2 patients were censored from ICD cohort and included in CRT-D cohort at the time of upgrade based on as-treated analysis principle.||percentage of true positives||95% Confidence Interval|Number
89208|NCT00916929|Primary|False Positive Rate|False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.|6-months|All patients participating in the study were included in the analysis with a total of 82 patients in each arm. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D. These 2 patients were censored from the ICD cohort and included in the CRT-D cohort at the time of upgrade based on as-treated analysis principle resulting.||departures from device threshold||95% Confidence Interval|Number
89209|NCT00916721|Primary|Change in the Corrugator Muscle (EMG) Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Corrugator EMG will be obtained through Ag/AgCl electrodes. The amplified EMG signal will be integrated using a 300-msec. time constant. A Coulbourn Modular Instrument System was used to measure corrugator EMG during 4 periods; baseline, reading, imagery and recovery|Corrugator EMG level was measured at visit 3, after presentation of two neutral and two smoking scripts|||µV||Standard Deviation|Mean
89210|NCT00916721|Primary|Change in Heart Rate (Beats Per Minute), Caused by Smoking Cues, Measured Using Script Driven Imagery|Heart rate was measured through 9-mm (sensor diameter) Ag/AgCl electrodes filled with electrolytic paste and placed on the medial surface of each forearm. Amplified electrocardiogram signal will input to a tachometer that will provide a voltage output reflecting interbeat interval, which will be transformed to HR. A Coulbourn Modular Instrument System was used to measure HR during 4 periods; baseline, reading, imagery and recovery|Heart rate was measured at visit 3, after presentation of two neutral and two smoking scripts|||beats per minute||Standard Deviation|Mean
89211|NCT00916721|Primary|Change in the Skin Conductance Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Skin conductance level was obtained through 9-mm (sensor diameter) Ag/AgCl electrodes filled with isotonic paste placed on the non-dominant hypothenar surface using a constant-voltage technique. A Coulbourn Modular Instrument System was used to measure SC during 4 periods; baseline, reading, imagery and recovery.|skin conductance was measured at visit 3, after presentation of two neutral and two smoking scripts|||µS||Standard Deviation|Mean
89212|NCT00916721|Secondary|Change in Craving Level to Smoking Cues Caused by Smoking Cues, Measured Using Script Driven Imagery|"Craving level will be measured using a 8 point Visual Analogue Scale (VAS) of craving. Participants will be ask How much do you want a cigarette right now Participants will answer accordingly: 0=no desire at all; 7=unable to resist craving"|Craving level was measured at visit 3, after presentation of two neutral and two smoking scripts|||units on a scale||Standard Deviation|Mean
89213|NCT00916643|Primary|Frequency and Severity of CHD Symptoms (Angina)|This is equatable to the incidence of Cardiovascular AEs.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.||participants|||Number
89214|NCT00916643|Primary|Serious Unexpected Adverse Events||Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.||participants|||Number
89215|NCT00916643|Primary|Occurrence of Cardiovascular Events and Interventions|Adverse Events reported for Cardiovascular disease not directly related to therapy.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.||participants|||Number
89216|NCT00916643|Primary|Occurence of Death|The Categories listed in the table are the Adverse Events (or similar) that resulted in death.|Participants were followed for one (1) year following discontinuation of treatment.|Inclusion was per protocol.||participants|||Number
89229|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Overall (0-393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89217|NCT00916383|Secondary|Safety, Tolerability, and Adhesion|See Adverse Event section for Safety assessment. Adhesion was assessed according to the following scoring criteria: Score 0 = approximately > 90% adhered (essentially no lift off the skin); Score 1 = approximately 75% to < 90% adhered (some edges only lifting off the skin); Score 2 = approximately 50% to < 75% adhered (less than half of the system lifting off the skin); Score of 3 = approximately < 50% adhered but not detached (more than half of the system lifting off the skin without falling off); Score of 4 = Patch-system detached (patch /overlay completely off the skin).|Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.||||||
89218|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||participants|||Number
89219|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.||participants|||Number
89220|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||participants|||Number
89221|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.||participants|||Number
89222|NCT00916383|Primary|Skin Irritation (Edema)|Edema was used to determine skin irritation using a modified Draize scale. Score 0 = no edema; Score 1 = very slight edema; Score 2 = slight edema; Score 3 = moderate to severe edema; Score 4 = severe edema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||units on a scale||Standard Deviation|Mean
89223|NCT00916383|Primary|Skin Irritation (Erythema)|Erythema was used to determine skin irritation using a modified Draize scale. Score 0 = no erythema; Score 1 = very slight erythema; Score 2 = well-defined erythema; Score 3 = moderate to severe erythema; Score 4 = severe erythema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.||units on a scale||Standard Deviation|Mean
89224|NCT00916383|Primary|Skin Irritation (Erythema and Edema)|Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.||units on a scale||Standard Deviation|Mean
89225|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89226|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89227|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89228|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89330|NCT00916136|Primary|Time to Pass Guidewire After Attaining Starting Point|Time to pass guidewire across reduced fracture once opening reamer is used in OR|Minutes|||minutes||Standard Deviation|Mean
89230|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89231|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89232|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89233|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89234|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89235|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89236|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Late (31 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89237|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Acute/Subacute (0 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89238|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Subacute (>1 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89239|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per Academic Research Consortium (ARC, definite/probable)|Acute (≤1 day)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89240|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89241|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89242|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89243|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89244|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89331|NCT00916136|Primary|Difference in the Two Groups in Regards to Resident Time.|Time from consult entered to time traction apparatus is applied.|in ED|||minutes||95% Confidence Interval|Mean
89245|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89246|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89247|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89248|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89249|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89250|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89251|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR||in-hospital|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89252|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89253|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89254|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89255|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89256|NCT00916370|Secondary|Cardiac Death/ All MI|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89257|NCT00916370|Secondary|Cardiac Death/All MI||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89258|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89259|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89260|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89261|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89262|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89263|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89264|NCT00916370|Secondary|All TVR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89265|NCT00916370|Secondary|All TVR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89266|NCT00916370|Secondary|All TVR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89267|NCT00916370|Secondary|All TVR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89268|NCT00916370|Secondary|All TVR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89269|NCT00916370|Secondary|All TVR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89270|NCT00916370|Secondary|All TLR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89271|NCT00916370|Secondary|All TLR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89272|NCT00916370|Secondary|All TLR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89273|NCT00916370|Secondary|All TLR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89274|NCT00916370|Secondary|All TLR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89275|NCT00916370|Secondary|All TLR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89276|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89277|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89278|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89279|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89280|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89281|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89282|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89283|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89284|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89285|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89286|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89287|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89288|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89289|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89290|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89291|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
91392|NCT00892957|Secondary|Percentage of Participants With Graft Occlusion|Determined clinically and defined as absence of blood flow through the graft.|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set||percentage of participants||95% Confidence Interval|Number
89292|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89293|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89294|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89295|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89296|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89297|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89298|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89299|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89300|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89301|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89302|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89303|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89304|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89305|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||In-hospital is less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
90096|NCT00909610|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
89306|NCT00916370|Secondary|Procedural Success (Subject Basis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.||percentage of participants|||Number
89307|NCT00916370|Secondary|Device Success (Lesion Basis)|Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.||percentage of lesions|Participants||Number
89308|NCT00916370|Secondary|Procedure Time|Procedure time is defined as time between insertion and withdrawal of guide catheter.|From insertion to withdrawal of guide catheter|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.||Minutes||Standard Deviation|Mean
89309|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).||percentage of participants|||Number
89310|NCT00916357|Secondary|Time to Percentage of Insulin Exposure (as Measured by Area Under the Curve [AUC])|Time to percentage of exposure to insulin, as measured by area under the curve (AUC), following a liquid meal for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes following after injection of study drug|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to percentage of insulin exposure as measured by area under the curve (AUC) data.||Minutes (min)||Standard Deviation|Mean
89311|NCT00916357|Secondary|Percentage of Participants Without Hypoglycemia|Percentage of participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 who did not experience hypoglycemia following a liquid meal is reported. Hypoglycemia was defined as any blood glucose values lower than 70 milligrams per deciliter (mg/dL) or symptoms of hypoglycemia responding to treatment with glucose. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20.||Percentage of participants|||Number
89312|NCT00916357|Secondary|Minimum Postprandial Glucose (PPG)|Minimum postprandial glucose (PPG) in participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable minimum postprandial glucose (PPG) data.||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
89313|NCT00916357|Secondary|Area Under the Time-Concentration Curve for Blood Glucose (AUC[BG])|Area under the time-concentration curve for blood glucose (AUC[BG]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 following a liquid meal is reported. AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 160 milligrams per deciliter (mg/dL) or 140 mg/dL, or lower than 70 mg/dL within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the time-concentration curve for blood glucose (AUC[BG]) data.||Milligrams per deciliter * minutes||Standard Deviation|Least Squares Mean
89314|NCT00916357|Secondary|Area Under the Concentration Time-Curve for Serum Insulin From Time 0 to the End of Blood Sampling (AUC[Last])|Area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) data.||Minutes * picomoles /1000 (min*pm/1000)||Standard Deviation|Least Squares Mean
89332|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||IU/dL||Standard Deviation|Mean
89315|NCT00916357|Secondary|Mean Residence Time From Time 0 to the End of Blood Sampling (MRT[Last])|Mean residence time from time 0 to the end of blood sampling (MRT[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable mean residence time from time 0 to the end of blood sampling (MRT[last]) data.||Minutes (min)||Standard Deviation|Mean
89316|NCT00916357|Secondary|Time to Late 50% Maximum Serum Insulin Concentration (Late[t50%])|Time to late 50% maximum serum insulin concentration (late[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to late 50% maximum serum insulin concentration (late[t50%]) data.||Minutes (min)||Standard Deviation|Mean
89317|NCT00916357|Secondary|Time to Early 50% Maximum Serum Insulin Concentration (Early[t50%])|Time to early 50% maximum serum insulin concentration (early[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, and 120 minutes after injection of each study drug.|Predose up to 120 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to early 50% maximum serum insulin concentration (early[t50%]) data.||Minutes (min)||Standard Deviation|Mean
89318|NCT00916357|Secondary|Time To Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (Tmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to maximum serum insulin concentration (Tmax) data.||Minutes (min)||Standard Deviation|Mean
89319|NCT00916357|Secondary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least one dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable maximum serum insulin concentration (Cmax) data.||Picomoles per liter (pm/L)||Standard Deviation|Mean
89320|NCT00916357|Primary|Postprandial Glucose (PPG) Excursion Following a Liquid Meal|Postprandial glucose (PPG) values in participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal are reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least square mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable postprandial glucose (PPG) excursion data.||Milligrams per deciliter (mg/dL)||Standard Deviation|Least Squares Mean
89321|NCT00916344|Secondary|Complication Free Rate|"Complication free rate (in %):~1 minus(the number of possibly pacemaker related complications divided by the number of patients)"|1- and 3- month follow-up completed|||Percentage complication free patients||95% Confidence Interval|Number
89322|NCT00916344|Primary|Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)|"atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.~atrial threshold test: measurable automatically or manually."|1 month follow-up completed|At 1 month follow-up 93 patients with dual chamber pacemaker had both manual and automatic atrial treshold tests (ITT analysis).||Volt|Participants|95% Confidence Interval|Mean
89323|NCT00916305|Primary|Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)|Weekly average over the previous month|1 months|||Decibels per week||Standard Deviation|Mean
89324|NCT00916305|Secondary|Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB|Daily average over the previous month|1 months|||Decibels per day||Standard Deviation|Mean
89325|NCT00916279|Secondary|Binary Restenosis|Subjects with percent diameter stenosis >50% in the analysis segment.|6 Months|ITT||participants|||Number
89326|NCT00916279|Primary|Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months|Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.|6 Months|ITT||percent diameter stenosis||Standard Deviation|Mean
89327|NCT00916279|Secondary|MACE Rate|Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).|30 Days|ITT||Percentage of patients|||Number
89328|NCT00916279|Secondary|Late Lumen Loss|Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).|6 months|ITT||(mm)||Standard Deviation|Mean
89329|NCT00916279|Primary|Percent Diameter Stenosis (%DS) in the Analysis Segment||6 months|ITT||Percentage stenosis of vessel diameter||Standard Deviation|Mean
89333|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||IU/dL||Standard Deviation|Mean
89334|NCT00916032|Secondary|Volume of Distribution at Steady State- One-stage aPTT Assay|computed as CL * MRT|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||dL/kg||Standard Deviation|Mean
89335|NCT00916032|Secondary|Volume of Distribution at Steady State- Chromogenic Assay|computed as Clearance (CL) * Mean residence time (MRT)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||dL/kg||Standard Deviation|Mean
89336|NCT00916032|Secondary|Mean Residence Time (MRT)- One-stage aPTT Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||hour||Standard Deviation|Mean
89337|NCT00916032|Secondary|Mean Residence Time (MRT)- Chromogenic Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||hour||Standard Deviation|Mean
89338|NCT00916032|Secondary|FVIII Clearance- One-stage aPTT Assay|Computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||mL/(kg·h)||Standard Deviation|Mean
89339|NCT00916032|Secondary|FVIII Clearance- Chromogenic Assay|computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||mL/(kg·h)||Standard Deviation|Mean
89340|NCT00916032|Secondary|Elimination Phase Half-life- One-stage aPTT Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|||hour||Standard Deviation|Mean
89341|NCT00916032|Secondary|Elimination Phase Half-life- Chromogenic Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|||hour||Standard Deviation|Mean
89342|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- One-stage aPTT Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
89343|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- Chromogenic Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
89344|NCT00916032|Secondary|Incremental Recovery at Cmax - One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
89345|NCT00916032|Secondary|Incremental Recovery at Cmax - Chromogenic Assay|Determined as the highest Factor VIII (FVIII) activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat||(IU/dL)/(IU/kg)||Standard Deviation|Mean
89346|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
89347|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
89348|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
89349|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat||(IU·h)/dL||Standard Deviation|Mean
89350|NCT00916006|Secondary|Patients With Partial Clearance of Actinic Keratosis (AK)|Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population||participants|||Number
89351|NCT00916006|Primary|Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.|Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population||participants|||Number
89352|NCT00915902|Primary|Change in Triglyceride Level||after 8 week treatment or placebo period|||mg/dL||Standard Deviation|Mean
89353|NCT00915876|Primary|Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56|Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56|Day 28 and Day 56|||nanogram/ml||Standard Deviation|Mean
89356|NCT00915798|Primary|Brain Activity|BOLD z-score of smokers with ADHD after abstinence/smoking a cigarette, control smokers after abstinence/smoking a cigarette, nonsmokers with ADHD, and control nonsmokers. All participants performed a mathematical task in the MRI scanner. Higher BOLD z-scores indicate greater brain activation.|One MRI session for nonsmokers and two MRI sessions for smokers|Discrepancies between participant flow and number of participants analyzed are due to motion artifacts, which compromised the MRI findings. Thus, a number of participants had to be excluded from the MRI data analysis.||z-score||Standard Deviation|Mean
89357|NCT00915772|Primary|Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE|Frequency of patients with adverse events by treatment, primary system organ class and preferred term|Baseline and drug stop (up to 54 weeks) + 7 days|Treated Set (TS)||participants|||Number
89358|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).|78 weeks|Non-switcher set (OC) with non-missing data at visit. Only patients who continued on the same treatment in both studies are included||Percentage||Standard Deviation|Mean
89359|NCT00915772|Secondary|Number of Patients With Rescue Therapy||54 weeks|TS||Number of patients|||Number
89360|NCT00915772|Secondary|Change in FPG From Baseline Over Time|Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit||mg/dL||Standard Deviation|Mean
89361|NCT00915772|Secondary|Number of Patients With HbA1c of at Least <0.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)||participant|||Number
89362|NCT00915772|Secondary|Number of Patients With HbA1c <6.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)||participant|||Number
89363|NCT00915772|Secondary|Number of Patients With HbA1c <7.0% After 54 Weeks||54 weeks|Treated Set with non completers considered as failures (NCF)||participant|||Number
89364|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit||Percentage||Standard Deviation|Mean
89365|NCT00915772|Primary|Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry|ULN means upper limit of normal|54 weeks|TS and observed cases (OC). In treatment group L2.5+M500, the number of patients analysed was 224 for lactate dehydrogenase abnormality and total bilirubin abnormality due to anailable data.||participants|||Number
89366|NCT00915772|Primary|Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology||54 weeks|TS and observed cases (OC)||participants|||Number
89367|NCT00915772|Primary|Change From Baseline at Week 54 in Pulse Rate|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)||beats per minute (bpm)||Standard Deviation|Mean
89368|NCT00915772|Primary|Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)||mmHg||Standard Deviation|Mean
89369|NCT00915772|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|54 weeks|Treated Set (TS): all screened patients who were documented to have taken at lease 1 dose of study drug.||participant|||Number
89370|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 3, ProKera and bandage contact lens were left in place until postoperative day 1.||days to complete re-epithelialization|Participants|Standard Deviation|Mean
89371|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 2, ProKera and bandage contact lens were left in place until postoperative day 3.||days to complete re-epithelialization|Participants|Standard Deviation|Mean
89372|NCT00915759|Secondary|Tear Protein Analysis||up to 1 month post-operatively||12/2013||||
89373|NCT00915759|Secondary|Corneal Clarity||one year postoperatively||12/2013||||
89374|NCT00915759|Secondary|Long-term Visual Outcomes||one year post-operatively||12/2013||||
89375|NCT00915759|Secondary|Visual Recovery||one year post-operatively||12/2013||||
89376|NCT00915759|Secondary|Complications/Adverse Events||one year post-operatively||12/2013||||
89377|NCT00915759|Secondary|Post-operative Pain|measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)|measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively||12/2013||||
89378|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK. For group 1, ProKera and bandage contact lens were left in place until complete corneal re-repithelialization (healing).||days to complete re-epithelialization|Participants|Standard Deviation|Mean
89379|NCT00915655|Secondary|Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]|The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable).|Week 24|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
89380|NCT00915655|Primary|Virological Response[Viral Load <50 Copies/mL, TLOVR]|The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.|Week 24|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
89381|NCT00915603|Secondary|Overall Survival (OS)|Assessed from Day 1 of study drug administration to date of death due to any cause.|every 8 weeks until treatment discontinuation, expected average 6 months|||months||95% Confidence Interval|Median
89382|NCT00915603|Secondary|Duration of Response (DOR)|Defined as time between date of objective response and date of response to disease progression or death, as defined by RECIST v1.1 criteria. Objective response is defined as either complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until treatment discontinuation, expected average 6 months|||months||95% Confidence Interval|Median
89383|NCT00915603|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 8 weeks until treatment discontinuation, expected average of 18 months|Includes patients who were enrolled and randomized||participants|||Number
89384|NCT00915603|Secondary|Number of Patients With Treatment-related Adverse Events (AEs) as a Measure of Safety and Tolerability|Assessments will be made based on the analysis of reported incidence of treatment-emergent AEs|every 4 weeks until intolerable toxicity occurs|Includes patients who were enrolled, randomized and treated||participants|||Number
89385|NCT00915603|Primary|Progression-Free Survival (PFS)|Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months|Includes all enrolled and randomized patients||months||95% Confidence Interval|Median
89386|NCT00915551|Secondary|Partial Clearance of Actinic Keratoses (AK)|Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population||participants|||Number
89387|NCT00915551|Primary|Complete Clearance of Actinic Keratoses (AK) Lesions|Complete clearance of the treatment field|baseline and 57 days|Intention to treat population||participants|||Number
89388|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89389|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89390|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89419|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
89391|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89392|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89393|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89394|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89395|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89396|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89397|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89442|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.|Number of patients in SR at day 13-18|During 13 to 18 days following study drug infusion|||Participants|||Number
89443|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion||During 24 hours following start of study drug infusion|||Participants|||Number
91393|NCT00892957|Secondary|Percentage of Participants With Postoperative Rebleeding|Any rebleeding requiring surgical re-exploration|Postoperative through day 30 ± 5|Intent to treat||percentage of participants||95% Confidence Interval|Number
89398|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89399|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89400|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89401|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89402|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89403|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89404|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89405|NCT00915525|Secondary|Change From Study Baseline in the King’s Health Questionnaire (KHQ) Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89406|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89407|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89408|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89409|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89410|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89411|NCT00915525|Secondary|Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
89638|NCT00913380|Other Pre-specified|Radiation Dose|"Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The length indicates the scan range."|1 day after CT|All participants who underwent CT. Intention to treat. Complete case analysis.||mGy•cm||Inter-Quartile Range|Median
89412|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89413|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89414|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89415|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89416|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89417|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Number of Episodes||Standard Deviation|Mean
89418|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
89657|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Ileus||7 days|||Participants|||Number
89420|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
89421|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
89422|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
89423|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Percentage of Patients|||Number
89424|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
89425|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
89426|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
89444|NCT00915356|Secondary|Heart Rhythm. Number of Participants With Early Relapse Into AF.|Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis.|Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR|||Participants|||Number
89445|NCT00915356|Secondary|Wide QRS Tachycardias|Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm).|From start of study drug infusion until discharge from hospital on study day 2.|||Participants|||Number
89427|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
89428|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
89429|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
89430|NCT00915499|Secondary|Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)|Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response.|3 months|||units on a scale||Standard Deviation|Mean
89431|NCT00915499|Primary|Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period|AHI refers to the number of apneas and hypopneas that occurred per hour of sleep|3 months|||AHI (events/hour)||Standard Deviation|Mean
89432|NCT00915473|Secondary|Mean Number of Days With Acute Medication Use|"Acute medication use meant the consumption of a drug to abort or terminate a headache."|4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||days per 4 weeks||Standard Deviation|Mean
89433|NCT00915473|Secondary|Mean Number of Hours With Moderate or Severe Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||hours per 4 weeks||Standard Deviation|Mean
89434|NCT00915473|Secondary|Mean Frequency of Days With a Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||days per 4 weeks||Standard Deviation|Mean
89435|NCT00915473|Primary|Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period|The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.|4 weeks pre-injection baseline, 4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.||participants|||Number
89436|NCT00915356|Secondary|Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion|Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion|Six hours following start of study drug infusion|||Percent of participants||95% Confidence Interval|Number
89437|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months|Subgroup analysis for patients with duration of current AF episode 31 days – 3 months. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion|||Participants|||Number
89438|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.|Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion|||Participants|||Number
89439|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days||Conversion from AF to SR within 90 minutes from start of infusion|||Participants|||Number
89440|NCT00915356|Secondary|Maximal Observed Plasma Concentration of AZD1305|Plasma concentration of AZD1305|Up to 24 hours following start of study drug infusion|||mol/L||Full Range|Median
89441|NCT00915356|Secondary|Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.||Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.||||||
89447|NCT00915356|Primary|Dose-response Relationship for QTcF Interval of AZD1305|QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date & time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed|At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).|||ms||95% Confidence Interval|Mean
89448|NCT00915343|Secondary|Comparison on 24-hour Urinary Free Cortisol Between Once Daily and Thrice Daily Therapy-Part A||12 weeks|Part A Safety population consisted of all randomised patients who took at least one dose of study medication. Safety population with participants evaluable for this outcome.||nanomoles per 24 hours||Standard Deviation|Mean
89449|NCT00915343|Secondary|Comparison on Participant Preference by Questionnaire Between Once Daily and Thrice Daily Therapy-Part A|"Participant Preference Questionnaire consisted of the following set of questions:~1. How large was the benefit with OD compared to TID and the responses were recorded as considerably poorer, somewhat poorer, comparable, large, very large; 2. How strongly concur with the following statement: I prefer novel OD to conventional TID and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly; 3. How strongly concur with the following statement: I prefer conventional TID to novel OD and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly."|Weeks 16 up to 28|Part A ITT population||percentage of preference|||Number
89450|NCT00915343|Secondary|Participant Compliance- Part B|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets – Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Up to Month 6 follow-up|Part B ITT population with participants evaluable for this outcome.||percentage use||Standard Deviation|Mean
89451|NCT00915343|Secondary|Comparison on Participant Compliance Between Once Daily and Thrice Daily Therapy - Part A|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets – Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Weeks 4 up to 28|Part A ITT population with participants evaluable for this outcome.||percentage use||Standard Deviation|Mean
89452|NCT00915343|Secondary|Change From Baseline to 6 Months in Diurnal Fatigue Questionnaire for Day Average- Part B|Diurnal fatigue scores (Visual Analog Scale [VAS] scores of energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89453|NCT00915343|Secondary|Change From Baseline to 12 Weeks in Diurnal Fatigue Questionnaire for Day Average of Once Daily Therapy - Part A|Diurnal fatigue was assessed at 8 ante meridian (AM), at 12 AM and at 4 post meridian (PM) by a visual analogue scale (VAS) based on 8 domains (energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity). Mean values were calculated for the morning (8 AM), the day (12 AM), the evening (4 PM) and mean per day (mean of 8 AM, 12 AM and 4 PM) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), Week 12|ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89454|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores- Part B|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89455|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores Between Once Daily and Thrice Daily Therapy- Part A|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89456|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score - Part B|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89457|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score Between Once Daily and Thrice Daily Therapy - Part A|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89458|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score - Part B|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value in the SF-36 questionnaire corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89459|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score Between Once Daily and Thrice Daily Therapy- Part A|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.||scores on a scale||Standard Deviation|Mean
89460|NCT00915343|Secondary|Percentage (%) of Participants With Change From Baseline in Patient Tolerability Questionnaire at Month 6, Assessed by Patient and Investigator – Part B|Patient tolerability questionnaire was assessed by both patient and investigator, the responses were as follows: improvement, no change, worsening and were reported.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.||percentage of participants|||Number
89461|NCT00915343|Secondary|Comparison of Overall Patient Tolerability Score Between Once Daily and Thrice Daily Therapy, Assessed by Patient and Investigator – Part A|"Overall patient tolerability score assessed by patient and investigator, ranged from 1 (feeling poor on treatment) to 5 (feeling very well on treatment). The average total score ranges from 1 to 5 with a higher score representing better tolerability of the treatment.~Questionnaire assessed by patient were I have been very poorly on the treatment, I haven’t been very well (or less well) on the treatment, I have been acceptably well on the treatment, I have been well on the treatment and I have been very well on the treatment. Questionnaire assessed by investigator were The patient has been feeling very poorly on the treatment, The patient has not tolerated the treatment well, The patient has tolerated the treatment less well, The patient has tolerated the treatment well and The patient has tolerated the treatment very well."|12 weeks|Part A ITT population||scores on a scale||Standard Deviation|Mean
89462|NCT00915343|Secondary|Accumulation Ratio (Rac) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The Rac was calculated as area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) on Day 28 divided by AUC0-24h on Day 1. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||ratio||Standard Deviation|Mean
89463|NCT00915343|Secondary|Percentage (%) of Fluctuation in Concentrations of S-cortisol at Steady State in Plasma After Single and Multiple Dosing During Part A|Percentage of fluctuation was calculated by using formula 100*(Cmax-minimum plasma concentration [Cmin])/Cavg,ss. It was peak trough fluctuation within one dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||percentage of fluctuation||Standard Deviation|Mean
89464|NCT00915343|Secondary|Percentage (%) of Area Under the Concentration Time Curve (AUC) Extrapolation of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) was calculated by using the formula AUC%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter was to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t). Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||percentage of AUC||Standard Deviation|Mean
89465|NCT00915343|Secondary|First Detectable Concentration Adjusted by Dose (Cfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||per liter||Standard Deviation|Mean
89466|NCT00915343|Secondary|Time to First Detectable Concentration Adjusted by Dose (Tfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||(hour per nanomole)*10^6||Standard Deviation|Mean
89526|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])|Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||ng*hr/mL||Standard Deviation|Mean
89467|NCT00915343|Secondary|Maximal Concentration Adjusted by Dose (Cmax1/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||per liter||Standard Deviation|Mean
89468|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State Adjusted by Dose (Css,av/Dose) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||per liter||Standard Deviation|Mean
89469|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 4 Hours Adjusted by Dose (AUC0-4h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
89470|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 10 Hours Adjusted by Dose (AUC0-10h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
89471|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 24 Hours Adjusted by Dose (AUC0-24h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
89472|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State Adjusted by Dose (AUCtau/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 14 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour per liter||Standard Deviation|Mean
89473|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State (AUCtau) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUCtau is defined as AUC during a dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hour*nanomole per liter||Standard Deviation|Mean
89483|NCT00915343|Secondary|First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
89474|NCT00915343|Secondary|Area Under the Concentration Time Curve (AUC) Between Specified Timepoints of Total S-cortisol in Plasma After Single and Multiple Dosing During Part A|"AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUC between specified timepoints included AUC0-4h, AUC4-12h, AUC6-12h, AUC12-24h, AUC0-10h, AUC4-10h, AUC6-10h, AUC10-24h, AUC(0-inf), AUC(24h-inf). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. Here, Nsignifies the number of participants evaluable for this outcome."|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population.||hour*nanomole per liter||Standard Deviation|Mean
89475|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 14 Hours (t1/2[5-14h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-14h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 14 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Standard Deviation|Mean
89476|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 24 Hours (t1/2[5-24h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-24h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 24 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Standard Deviation|Mean
89477|NCT00915343|Secondary|Time to Reach a Concentration of 200 Nanometers (nM) (T200) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
89478|NCT00915343|Secondary|Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
89479|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax2 is the Tmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
89480|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax1 is the Tmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||hours||Full Range|Median
89481|NCT00915343|Secondary|Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
89482|NCT00915343|Secondary|Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
89484|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
89485|NCT00915343|Secondary|Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax2 is the Cmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
89486|NCT00915343|Secondary|Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.||nanomoles per liter||Standard Deviation|Mean
89487|NCT00915343|Primary|Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A: Intention-To-Treat (ITT) set included all randomised participants who took at least 1 dose of study drug with primary efficacy assessments including all pharmacokinetic (PK) samplings during either treatment period. Here “number of participants analysed” signifies those who were evaluable for the outcome measure.||hour*nanomole per liter||Standard Deviation|Mean
89488|NCT00915278|Secondary|Number of Participants With Perforin Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Perforin.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89489|NCT00915278|Secondary|Number of Participants With Ki67 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Ki67.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89490|NCT00915278|Secondary|Number of Participants With Caspase 3 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Caspase 3.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89491|NCT00915278|Secondary|Number of Participants With CD31 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD31.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89492|NCT00915278|Secondary|Number of Participants With pFAK Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against pFAK.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89493|NCT00915278|Secondary|Number of Participants With CD16 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD16.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD16 expression.||Participants|||Number
89494|NCT00915278|Secondary|Number of Participants With CD56 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD56.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD56 expression.||Participants|||Number
89495|NCT00915278|Secondary|Number of Participants With Granzyme B Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Granzyme B.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89496|NCT00915278|Secondary|Number of Participants With CD68 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies CD68.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89497|NCT00915278|Secondary|Number of Participants With Integrin Alpha 5 Beta 1 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against integrin alpha 5 beta 1.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.|||||
89658|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Nausea|Nausea at any time during the post operative period for 48 hours|Immediate post operative to 48 hours|||Participants|||Number
89499|NCT00915278|Secondary|Percent Change in Initial Area Under the Curve (IAUC)|Percent change in the IAUC for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 Day 15. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.|||||
89500|NCT00915278|Secondary|Percent Change in Transfer Constant (Ktrans) From Baseline to Cycle 1 Day 15|Percent change in Ktrans for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 day 15 aimed at defining the effect of PF-04605412 on tumor vasculature.|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.|||||
89501|NCT00915278|Secondary|Objective Response - Number of Participants With Objective Response|"Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.~Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions."|Baseline up to 6 weeks after the first infusion of PF-04605412 (end of Cycle 2) and approximately every 6 weeks thereafter only in the absence of progressive disease|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.||participants|||Number
89502|NCT00915278|Secondary|Number of Participants Positive for Anti-PF04605412 Antibodies|Serum samples were analyzed for anti-drug antibodies (ADA) or human anti-human antibodies (HAHA). This was used to evaluate immunogenicity.|Baseline up to end of treatment|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.||participants|||Number
89503|NCT00915278|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Vss.||Liter||Geometric Coefficient of Variation|Geometric Mean
89504|NCT00915278|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CL.||Liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
89505|NCT00915278|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Tmax.||hours||Full Range|Median
89506|NCT00915278|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable t1/2.||hours||Standard Deviation|Mean
89507|NCT00915278|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]|AUC (0 - inf)= Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUC (0 - inf).||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
89508|NCT00915278|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUClast.||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
89509|NCT00915278|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Cmax.||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
89510|NCT00915278|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any >= Grade 3 adverse event (AE) graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF‑04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.|Baseline up to 6 weeks PF-04605412|All subjects enrolled in the dose escalation part of the study who received at least one dose of study medication that remained on study and/or provided safety follow-up for at least 6 weeks, unless discontinuing due to a DLT. Subjects discontinuing the study due to DLT are included||participants|||Number
89512|NCT00915148|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound|Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.|during labor|||percentage probability||95% Confidence Interval|Number
89513|NCT00914966|Secondary|Use of Rescue Therapy and/or Other Therapy for Treatment of HAE Symptoms||12 weeks at each dose level||||||
89514|NCT00914966|Secondary|Treatment Effect of Escalating Doses of CINRYZE on HAE Attack Rates|"Two definitions of success were applied in this study:~Per-protocol success - Average angioedema attack rate of ≤1.0 per month at the end of any dose escalation step (Week 12). The a priori definition of study success was 4 or more subjects with per-protocol success.~Investigator-determined success - Based on the investigator's clinical judgment, an average monthly angioedema attack rate demonstrating improvement sufficient for progression to follow-up.~In addition, subjects who were not a per-protocol or investigator-determined success, but who experienced a reduction of >1.0 attack per month from their historical angioedema attack rate at the end of any dose escalation step (Week 12), were summarized."|12 weeks at each dose level|||participants|||Number
89515|NCT00914966|Primary|Number of Subjects With Adverse Events, Hospitalizations, Thrombotic Events, Treatment-emergent C1 INH Antibodies, Post-baseline Toxicity Grade Increases in Clinical Laboratory Parameters, and Post-dose Vital Signs Changes of Potential Clinical Importance|Events reported during the 3 month follow-up period are counted with the dose level at which they occurred.|12 to 24 weeks at each dose level|||participants|||Number
89516|NCT00914862|Secondary|Number of Participants With Clinically Significant Physical Examination Results|A complete physical examination was performed for each participant at Screening, Check-in (Day 1), Day 2, and Final Visit (Day 4) or Early Termination. The examination consisted of a review of the following body systems: eyes; ears, nose, and throat; respiratory; gastrointestinal; extremities; musculoskeletal; cardiovascular; nervous; and dermatological.|Screening, Day 1, Day 2 and Day 4|Safety set.||participants|||Number
89517|NCT00914862|Secondary|Number of Participants With Clinically Significant Electrocardiogram Findings|A standard 12-lead electrocardiogram (ECG) was recorded at Screening, Day 2, and at Final Visit (Day 4). The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Screening, Day 2 and Day 4|Safety set.||participants|||Number
89518|NCT00914862|Secondary|Number of Participants With Clinically Significant Vital Signs|Vital signs included oral body temperature, pulse and blood pressure (taken after 5 minutes in the sitting position). Vital signs measurements were determined to be clinically significant according to predefined criteria.|Screening, Day 1, Day 2 and Day 4|Safety set.||participants|||Number
89519|NCT00914862|Secondary|Number of Participants With Clinically Significant Laboratory Findings|Laboratory samples were collected at Screening, Check-in (Day 1), and Day 2 or Early Termination for assessment of hematology, chemistry, and urinalysis.|Screening, Day 1, Day 2 and Day 4|Safety set.||participants|||Number
89520|NCT00914862|Secondary|Number of Participants With Adverse Events (AE)|"An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows:~Mild: The event was transient and easily tolerated by the participant.~Moderate: The event causes the participant discomfort and interrupted usual activities.~Severe: The event causes considerable interference with the participant’s usual activities."|Day 1 to Day 15|The safety set includes all participants who received at least 1 dose of study drug.||participants|||Number
89521|NCT00914862|Primary|Apparent Volume of Distribution (Vz/F)|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||Liters||Standard Deviation|Mean
89522|NCT00914862|Primary|Terminal Elimination Half-life (T1/2)|Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln[2]) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||hours||Standard Deviation|Mean
89523|NCT00914862|Primary|Terminal Elimination Rate Constant (λz)|The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||1/hour||Standard Deviation|Mean
89524|NCT00914862|Primary|Apparent Clearance After Oral Administration (CL/F)|"Apparent oral clearance of drug from the serum calculated as:~CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf])."|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||L/hr||Standard Deviation|Mean
89525|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC[0-inf])|Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||ng*hr/mL||Standard Deviation|Mean
89527|NCT00914862|Primary|Time to Reach Maximum Serum Concentration (Tmax)|Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.||hours||Full Range|Median
89528|NCT00914862|Primary|Maximum Observed Serum Concentration (Cmax)|Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|The Pharmacokinetic (PK) set, which consisted of all patients who received study drug and had sufficient concentration data to calculate at least 1 PK parameter.||ng/mL||Standard Deviation|Mean
89529|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure||Up to Day 2|||participants|||Number
89530|NCT00914849|Secondary|Rate of Chronic GVHD in Recipients||Day 101-1 year|8 patients are not evaluable because they were not alive for the outcome measure time frame.||participants|||Number
89531|NCT00914849|Secondary|Grade 3-4 Toxicity for Recipients|Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.|1 year|||participants|||Number
89532|NCT00914849|Secondary|Transplant Related Mortality Rate for Recipients|Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.|Day 100|||participants|||Number
89533|NCT00914849|Secondary|Time to Platelet Engraftment for Recipients|Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.|Up to Day 100|||days||Full Range|Median
89534|NCT00914849|Secondary|Time to Neutrophil Engraftment for Recipients|Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.|Up through Day 100|||days||Full Range|Median
89535|NCT00914849|Secondary|Rate of Acute GVHD (Grade III-IV) in Recipients||Day 0-Day 100 (acute)|||participants|||Number
89536|NCT00914849|Secondary|Rate of Acute GVHD (Grade II-IV) in Recipients||Day 0-Day 100 (acute)|||participants|||Number
89537|NCT00914849|Secondary|Pharmacodynamics of IV AMD3100 on Stem Cell and T-cell Phenotyping and on Immune Reconstitution After Transplantation.||Day 1 and Day 2||10/2016||||
89538|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by Half Life|"-Blood samples for pharmacokinetics were drawn on the following schedule:~prior to IV infusion~15 minutes after start of infusion~30 minutes after start of infusion~1 hour after start of infusion~4 hours after start of infusion~6 hours after start of infusion~9 hours after start of infusion~24 hours after start of infusion"|Day 1 and Day 2|||hours||Standard Deviation|Mean
89539|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)|"-Blood samples for pharmacokinetics were drawn on the following schedule:~prior to IV infusion~15 minutes after start of infusion~30 minutes after start of infusion~1 hour after start of infusion~4 hours after start of infusion~6 hours after start of infusion~9 hours after start of infusion~24 hours after start of infusion"|Day 1 and Day 2|||ng/mL||Standard Deviation|Mean
89540|NCT00914849|Secondary|Number of Recipients Who Have Neutrophil Engraftment||Day 21|||participants|||Number
89541|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Infusional Toxicity||Up to Day 2|||participants|||Number
89542|NCT00914849|Primary|Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant||Completion of enrollment of all donors (17 months)|3 donors failed to reach target after two collections and 1 donor withdrew consent after failing to reach the goal on the first collection.||participants|||Number
89543|NCT00914810|Secondary|Change in Blood Level of Vitamin D (25-hydroxyvitamin D)||Baseline and 6 weeks|25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial.||ng/mL||Standard Deviation|Mean
89544|NCT00914810|Primary|Change in Short Physical Performance Battery (SPPB) Score|SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.|Baseline and 6 weeks|||units on a scale||Standard Deviation|Mean
89545|NCT00914589|Secondary|Percentage of Subjects With Serious Adverse Events|Percentage of subjects with serious adverse events until end of trial.|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.||percentage (%) of subjects|||Number
89546|NCT00914589|Secondary|Percentage of Subjects With Critical Adverse Events|Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.||percentage (%) of subjects|||Number
89547|NCT00914589|Secondary|Percentage of Subjects With rFXIII Antibody Reaction|Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.|measured from screening until 5-7 weeks post Trial Drug Administration|Safety analysis set includes all subj. exposed to at least one dose of trial product. 1 subj with a low titre antibody at baseline was also reported with low titre FXIII antibody at visit 8. 27, 19 and 17 subjects in placebo, FXIII 17.5 and 35 IU/KG, respectively, did not have antibody measurement.||participants|||Number
89548|NCT00914589|Secondary|Percentage of Subjects With Thromboembolic Events|Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.||percentage of subjects|||Number
89549|NCT00914589|Primary|Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First|Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.|measured ongoing from dosing until day 7 or discharge, whichever came first|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment.||percentage (%) of subjects|||Number
89551|NCT00914459|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): All Participants|An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 30 days after last study visit (Month 25)|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||participants|||Number
89552|NCT00914459|Secondary|Mean Residence Time (MRT) of ReFacto AF|MRT was calculated as AUMCinf / AUCinf-TI/2, where AUMCinf is the area under the first moment curve from time zero to infinity and TI was the duration of infusion.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||hour||Full Range|Median
89553|NCT00914459|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||mL/kg||Geometric Coefficient of Variation|Geometric Mean
89554|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)|AUClast is the area under the plasma versus time curve from time zero to time of last measurable concentration (AUClast)|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
89555|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was calculated as International units*hour per milliliter (IU*hr/mL).|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
89556|NCT00914459|Secondary|Plasma Concentration of Factor VIII at 0.5 Hour Post-dose (C0.5)||0.5 hour post-dose on Day 1|The PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
89557|NCT00914459|Secondary|Number of Participants Requiring Escalated Dose of Prescribed Regimen During the Treatment Period: All Participants|Participants who met the dose escalation criteria were prescribed a higher dose and/or more frequent doses as per the investigator’s discretion.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who used a prophylaxis regimen were analyzed for this outcome measure.||participants|||Number
89558|NCT00914459|Secondary|Number of Occurrences of Less-Than-Expected-Therapeutic Effect (LETE) in the Low Recovery Setting: All Participants|LETE in the low recovery setting was defined as lower than expected recovery of FVIII (in the opinion of investigator), following the infusion of ReFacto AF in the absence of confounding factors for the low recovery. The only confounding factors for low recovery are as follows: known presence or subsequent identification of a FVIII inhibitor, known compromised ReFacto AF, faulty administration of ReFacto AF, including inadequate dosing.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||LETE bleeds|||Number
89559|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the Prophylaxis Setting: All Participants|LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (<=48 hours) after a regularly scheduled prophylactic dose of ReFacto AF (which was not used to treat a bleed) in the absence of confounding factors. Therefore, LETE in the prophylaxis setting is the occurrence of a bleed. Confounding factors include: Known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose, known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised ReFacto AF, faulty administration of ReFacto AF, an underlying, predisposing condition responsible for the bleed in the opinion of the investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs) or traumatic injury responsible for bleeding.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who received at least 1 prophylaxis dose of ReFacto AF were reported.||LETE bleeds|prophylaxis infusions||Number
89568|NCT00914459|Primary|Terminal Elimination Half Life of ReFacto AF (t1/2)|T1/2 was the time for the plasma concentration of drug to decrease by one-half of its original concentration.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||hours||Standard Deviation|Mean
93719|NCT00868140|Primary|Fasting Serum Insulin (uIU/ml)|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo|6 months|||uIU.min/ml||Standard Error|Mean
89560|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the On-Demand Setting: All Participants|"LETE in on-demand setting was based on response to treatment of a bleeding episode. LETE in the on-demand setting occurred if participant recorded 2 successive no response ratings after 2 successive ReFacto AF infusions. Both infusions were to be administered at an interval of 24 hours for treatment of same bleeding event in absence of confounding factor which included: known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of greater than 4 hours between onset of bleed to infusion, delay of greater than 24 hours before administration of a follow-up infusion, known compromised ReFacto AF, faulty administration of ReFacto AF, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs),or ongoing trauma responsible for continued bleeding."|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, “number of participants analyzed” signifies participants who were evaluable for this outcome measure and received treatment for at least one bleed.||LETE bleeds|bleeding episodes||Number
89561|NCT00914459|Secondary|Total Factor VIII Consumption: All Participants|Total factor VIII consumption for each participant was calculated by sum of the total amount of ReFacto AF (in IU) infused for each ReFacto AF infusion (recorded in the infusion log diary CRF). Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."||IU||Standard Deviation|Mean
89562|NCT00914459|Secondary|Average Infusion Dose of ReFacto AF: All Participants|The average infusion dose (by weight) for each participant was calculated as his total factor FVIII consumption (in IU) divided by weight (in kg) divided by the number of infusions administered in total study duration. Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."||IU/kg||Standard Deviation|Mean
89563|NCT00914459|Secondary|Number of Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of ReFacto AF: All Participants|The number of breakthrough bleeds within 48 hours following a prophylaxis dose of ReFacto AF was summarized. The infusion log diary CRF was used to determine the number of infusions administered to treat a new bleed counting only those infusions which were administered <=48 hours after an infusion marked as “prophylaxis” (which had no associated bleed).|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||breakthrough bleeds||Standard Deviation|Mean
89564|NCT00914459|Secondary|Number of On-Demand ReFacto AF Infusions to Treat a New Bleed: All Participants|"The infusion log diary case report form (CRF) was used to determine the number of on-demand (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) ReFacto AF infusions administered to treat a new bleed. This was calculated by adding the initial for a new bleed (on-demand) infusion to any subsequent (on-demand) infusions for the same previously treated bleed (same bleed with same start date/time)."|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure."||infusions|bleeds|Standard Deviation|Mean
89565|NCT00914459|Secondary|Response to First On-Demand Treatment for New Bleeds: All Participants|A 4-point scale of assessment of ‘on-demand’ treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: 1. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. 2. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode;or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following infusion, with no additional infusion administered. 3. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. 4. No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and received at least 1 dose of ReFacto AF for at least one bleeding episode."||responses|bleeds||Number
89566|NCT00914459|Secondary|Mean Annualized Bleeding Rates (ABRs): All Participants|ABR for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by the total therapy duration (in days), then multiplied by 365.25. ABR for the participants who reported following a primary or secondary prophylaxis, on-demand regimen or preventive regimen at baseline were reported.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at the specified time points."||bleeds per year||Standard Deviation|Mean
89567|NCT00914459|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."||milliliter per hour per kilogram||Geometric Coefficient of Variation|Geometric Mean
89698|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Levels|Urinary Glycosaminoglycan (GAG) Levels: Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 26|||ug/mg||Standard Deviation|Mean
89569|NCT00914459|Primary|Incremental Recovery|Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of ReFacto AF administered per kilogram of body weight. It was measured in international units per deciliter (IU/dL) per international units per kilogram (IU/kg).|Days 1, 15, 50, Months 6, 18 and Final visit (up to Month 24)|"The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable at the specified time point for each arm respectively."||(IU/dL)/(IU/kg)||Standard Deviation|Mean
89570|NCT00914459|Primary|Percentage of Participants With Clinically Significant Factor VIII Inhibitor Development|Clinically significant factor VIII (FVIII) inhibitors were defined as a central laboratory confirmed positive inhibitor of greater than or equal to (>=) 0.6 Bethesda units (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval and one of the following within 4 weeks before the initial or within 4 weeks following the second positive FVIII inhibitor sample collection: 1) the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, 2) >=2 events indicating a decrease in the efficacy of the study treatment. Percentage of participants who developed clinically significant Factor VIII inhibitor after study drug administration were reported.|Baseline up to Month 24|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.||percentage of participants||95% Confidence Interval|Number
89571|NCT00914186|Primary|Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale|"Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from No Itch, even the slightest itch or Slight Itch, to Worst Itch Imaginable to denote the increase in severity of itching."|Baseline through Study Day 36 (Visit 7)|||participants|||Number
89572|NCT00914186|Primary|Skindex-29 Questionnaire to Measure the Subject’s Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.|Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject’s overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.|Study Day -7 through Study Day 22|ITT||units on a scale||Standard Deviation|Mean
89573|NCT00914186|Primary|Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas|The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.|baseline through Study Day 36 (Visit 7)|ITT analysis||units on a scale||Standard Deviation|Mean
89574|NCT00914186|Primary|Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score|self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)|Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)|ITT||units on a scale||95% Confidence Interval|Mean
89575|NCT00914186|Primary|Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas|investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)|baseline through Study Day 36 (Visit 7)|ITT||units on a scale||95% Confidence Interval|Mean
89576|NCT00914186|Primary|Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events|Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms|Baseline through Study Day 36 (Visit 7)|total number of subjects who received study drug.||participants|||Number
89577|NCT00914186|Primary|Change in Pruritis Visual Analog Scale (VAS)|Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale|Baseline through Study Day 36 (Visit 7)|Intent To Treat (ITT) analysis||mm||Standard Deviation|Mean
89578|NCT00913913|Other Pre-specified|Clinical Response|clinical response by RECIST 1.1|Day 70|||participants|||Number
89579|NCT00913913|Other Pre-specified|Measure of Percent of CD4 and CD8 Lymphocyte Subsets|percent of CD4 and CD8 positive lymphocyte subsets|Baseline, day 28, day 70|Peripheral blood lymphocyte subsets: 5 subjects at baseline and same 5 at day 70. 6 subjects analyzed at day 28||percentage of total lymphocytes||Full Range|Mean
89580|NCT00913913|Secondary|To Characterize the Number of Participants With Clinical and Autoimune Related Toxicity of Treatment|To characterize the clinical and autoimmune related toxicity profile of the combined treatment regimen using CTCAE 3. Toxicity reported are those expected from high dose IL-2 and were not considered adverse events.|5 years|||participants|||Number
89581|NCT00913913|Primary|Progression Free Survival|median progression free survival|5 years|||DAYS||Full Range|Median
89582|NCT00913770|Secondary|Days of Self-reported Illicit Opioid Use in the Past 7 Days||30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104||Mean Number of Days||95% Confidence Interval|Mean
90073|NCT00909779|Secondary|The Incidence of All Cause Mortality|Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
89583|NCT00913770|Primary|Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)|Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.|30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104||Mean Number of Outpatient Visits||95% Confidence Interval|Mean
89584|NCT00913744|Primary|Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28|The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation|Day 28|The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method.||percentage of subjects|||Number
89585|NCT00913692|Secondary|Does Oral Glutamine Reduce the Area of Recurrent Lesions?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences, start and end dates of each recurrence and measurement of each lesion during each phase of the study would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||mm squared||Standard Deviation|Median
89586|NCT00913692|Secondary|Does Oral Glutamine Reduce the Duration of Recurrences?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||days||Standard Deviation|Median
89587|NCT00913692|Secondary|Does Oral Glutamine Reduce the Time to First Recurrence of Herpes Labialis Diagnosed by Clinical and Microbiologic Criteria or Diagnosed by Clinical Criteria With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||days||Standard Deviation|Median
89588|NCT00913692|Secondary|Does Oral Glutamine Reduce the Number of Clinical Recurrences of Herpes Labialis With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.||herpes labialis lesions||Standard Deviation|Median
89589|NCT00913692|Primary|Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease.|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of outbreaks would be measured during each phase.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.||herpes labialis lesions|||Number
89590|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
89591|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
89592|NCT00913523|Secondary|Abundance of Selected Microflora in Tampons|Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism.|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||CFU/gm||Standard Deviation|Mean
89593|NCT00913523|Secondary|Percentage of Subjects With Selected Microflora in Tampons|Percentage of subjects with selected relevant microorganisms in tampons during menses|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
89594|NCT00913523|Secondary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
89595|NCT00913523|Primary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.||Percentage of Participants|||Number
89596|NCT00913510|Primary|Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.|Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)*100%.|Baseline and 8 weeks after randomization.|||percent change||Standard Deviation|Mean
89597|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
89598|NCT00913458|Secondary|WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
89599|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
89600|NCT00913458|Secondary|WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||units on a scale||Standard Deviation|Mean
89601|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
89619|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participant who took at least 1 dose of open-label investigational product||participants|||Number
89602|NCT00913458|Secondary|WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 Weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||units on a scale||Standard Deviation|Mean
89603|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Error|Least Squares Mean
89604|NCT00913458|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||units on a scale||Standard Deviation|Mean
89605|NCT00913458|Secondary|Change From Baseline mTSS at Week 91 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|||Units on a scale||Standard Error|Least Squares Mean
89606|NCT00913458|Secondary|Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
89607|NCT00913458|Secondary|Number of Participants Achieving Patient Acceptable Symptom State (PASS)|The PASS is defined as a symptom state that the subjects consider acceptable.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
89608|NCT00913458|Secondary|Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)|100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||mm||Standard Deviation|Mean
89609|NCT00913458|Secondary|Participant's Global Assessment of Disease Activity|Participant’s Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
89610|NCT00913458|Secondary|Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Units on a scale||Standard Deviation|Mean
89635|NCT00913380|Secondary|Visualization of the Normal Appendix|Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."||participants|||Number
90097|NCT00909610|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
89611|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 2 was defined as:~DAS28 <2.6 at the Week 76 and Week 91 visits and~No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.~Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder"|52 and 91 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
89612|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
89613|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
89614|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
89615|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
89616|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
89617|NCT00913458|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||participants|||Number
89618|NCT00913458|Secondary|Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit|The PASS is defined as a symptom state that the participants consider acceptable.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
91826|NCT00887809|Primary|Overall Objective Response|Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|6 months|||participants|||Number
89620|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
89621|NCT00913458|Secondary|Change From Baseline in DAS44 Score at All Visits|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
89622|NCT00913458|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|Participant’s Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
89623|NCT00913458|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Units on a scale||Standard Deviation|Mean
89624|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
89625|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
89626|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
89627|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
89636|NCT00913380|Secondary|Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.|"True positive: Perforation was rated as present in CT report and confirmed as present.~False positive: Perforation was rated as present in CT report and confirmed as absent.~True negative: Perforation was rated as absent in CT report and confirmed as absent.~False negative: Perforation was rated as absent in CT report and confirmed as present.~The data are used to calculate sensitivity and specificity."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."||participants|||Number
89637|NCT00913380|Other Pre-specified|Estimate of Carcinogenic Risk Induced by CT Radiation|Age- and sex-specific carcinogenic risk induced by CT radiation. This is not an actual measurement but an estimate of the stochastic risk, based on assumption and calculation from radiation dose used.|1 day after CT||||||
89628|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
89629|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
89630|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
89631|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||units on a scale||Standard Deviation|Mean
89632|NCT00913458|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Units on a scale||Standard Deviation|Mean
89633|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 1 was defined as:~DAS28 <2.6 at the week 39 and 52 visits and,~No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,~Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits"|End of Phase 1|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product||Participants|||Number
89634|NCT00913458|Primary|Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score|"Sustained remission was defined as a DAS28 <2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 >3.2 at either the Week 56 or Week 64 visit.~DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity.~The participants who met sustained remission in both Week 76 and 91 are presented here."|76 and 91 weeks|Modified intent-to-treat (mITT) population, which included all participants who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.||Participants|||Number
91827|NCT00887744|Secondary|Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.||From baseline up to 12 months follow up|||Proportion of patients (%)|||Number
89639|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.~Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."||participants|||Number
89640|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.~Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."||participants|||Number
89641|NCT00913380|Secondary|Interval From CT to Discharge After Appendectomy|Time interval between the CT acquisition and discharge after appendectomy|3 months after CT|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.||day||Inter-Quartile Range|Median
89642|NCT00913380|Secondary|Interval Between CT and Discharge Without Surgery|Time interval between the CT acquisition and discharge without surgery|3 months after CT|Participants who did not undergo surgery. Intention to treat. Complete case analysis.||hr||Inter-Quartile Range|Median
89643|NCT00913380|Secondary|Interval Between CT and Appendectomy|Time interval between the CT acquisition and non-incidental appendectomy|1 day after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.||hr||Inter-Quartile Range|Median
89644|NCT00913380|Secondary|Appendiceal Perforation|Number of participants with appendiceal perforation|1 week after surgery|Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.||participants|||Number
89645|NCT00913380|Secondary|Additional Imaging Test(s)|Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis|1 week after CT|All participants included in outcome analyses. Intention to treat. Complete case analysis.||participants|||Number
89646|NCT00913380|Primary|Negative Appendectomy|Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)|1 week after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.||participants|||Number
89647|NCT00913263|Secondary|Number of Days to Prostate Volume Nadir.|Number of Days from day of injection to prostate volume nadir.|Measured every 4th week until progression or maximum 6 months.|||Days||95% Confidence Interval|Median
89648|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Final Visit|Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline|Measured every 4th week until progresion or maximum 6 months.|||percentage change||Standard Deviation|Median
89649|NCT00913263|Secondary|Time to PSA Nadir|Time frame was from baseline to day of PSA nadir.|Measured every 4th week until progression or maximum 6 moths.|||Number of days from baseline to PSA nadi||95% Confidence Interval|Number
89650|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Nadir.|Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.|Measured every 4th week until progression or maximum 6 months.|||percent change||Standard Deviation|Median
89651|NCT00913263|Secondary|Number of Patients Reporting Adverse Events Caused by the Study Treatment|"Adverse events caused by the study treatment~Abnormal, clinically relevant, laboratory parameters~Voiding symptoms~Vital Signs~Quality of Life"|Measured every 4th week till progression or maximum 6 months|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, should be included in the efficacy analysis.~Study population safety All patients who received at least one dose of Liproca® Depot should be included in the safety analysis."||Patients reporting study related AE|||Number
89652|NCT00913263|Primary|Proportion of Patients Showing PSA Nadir|Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.|Measured every 4th week until progression or maximum 6 months.|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, were included in the efficacy analysis.~Study population safety All patients who received at least one dose of Liproca® Depot were included in the safety analysis."||percentage of patients with PSA nadir||95% Confidence Interval|Number
89653|NCT00913133|Secondary|Thrombosis|"New onset symptomatic thrombosis requiring medical or surgical intervention;~Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction."|Up until 24 hours after last dose of study drug|Patients who received at least one dose of study drug||participants|||Number
89654|NCT00913133|Primary|Major Bleeding|Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.|24 hours after last dose of study drug|All patients receiving at least one dose of study drug||participants|||Number
89655|NCT00913081|Primary|Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin|Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.|8 hour period|All subjects who finished at least one visit were analysed.||Fold change over baseline||95% Confidence Interval|Mean
89656|NCT00913003|Primary|24 Hour Hydromorphone|Total IV hydromorphone administered during surgery to 24 hours post surgery|24 hour|||miligrams||Standard Deviation|Mean
89659|NCT00912964|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
89660|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.||participants|||Number
89661|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.||participants|||Number
89662|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale|The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.||participants|||Number
89663|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician’s office during the 4 weeks prior to each study visit (excluding study visits) because of the patient’s bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
89664|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Error|Least Squares Mean
89665|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Error|Least Squares Mean
89666|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Deviation|Mean
89667|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
89668|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
89669|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
89670|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
89671|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
89672|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percent activity impairment||Standard Deviation|Mean
89673|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent overall work impairment||Standard Deviation|Mean
89699|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one's arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week 26|||Degrees||Standard Deviation|Mean
91839|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 6 months|6 months|||units on a scale||Full Range|Median
89674|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent impairment while working||Standard Deviation|Mean
89675|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent work time missed||Standard Deviation|Mean
89676|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||scores on a scale||Standard Error|Least Squares Mean
89677|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||scores on a scale||Standard Error|Least Squares Mean
89678|NCT00912964|Secondary|Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes|Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||percentage of participants|||Number
89679|NCT00912964|Secondary|Percentage of Responders for Mean Level of Urgency|Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence).|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||percentage of participants|||Number
89680|NCT00912964|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
89681|NCT00912964|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
89682|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||pads||Standard Error|Least Squares Mean
89683|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||nocturia episodes||Standard Error|Least Squares Mean
89684|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized for this analysis. The number of participants included in the calculation for each time point is noted as N."||scores on a scale||Standard Error|Least Squares Mean
89685|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was not utilized for this analysis. N is the number of patients included at each time point.||Urgency episodes||Standard Error|Least Squares Mean
89686|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode (grade 3 or 4) at baseline. LOCF was not utilized.||Urgency incontinence episodes||Standard Error|Least Squares Mean
89687|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as N."||mL||Standard Error|Least Squares Mean
89688|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.||Incontinence episodes||Standard Error|Least Squares Mean
89689|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.||micturitions||Standard Error|Least Squares Mean
89690|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. Last observation carried forward was utilized.||urgency episodes||Standard Error|Least Squares Mean
89691|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.||urgency incontinence episodes||Standard Error|Least Squares Mean
89692|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||scores on a scale||Standard Error|Least Squares Mean
89693|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.||micturitions||Standard Error|Least Squares Mean
89694|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was not utilized in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
89695|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||micturitions||Standard Error|Least Squares Mean
89696|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||mL||Standard Error|Least Squares Mean
89697|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.||Incontinence episodes||Standard Error|Least Squares Mean
89847|NCT00911495|Secondary|Total Plasma Clearance||48 hours|All subjects were analyzed for pharmacokinetics; one subject of the 15 enrolled was lost to follow-up.||mL/h/kg||Standard Deviation|Mean
89700|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ) = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to week 26|||Units on a scale||Standard Deviation|Mean
89701|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 26|||Cubic centimeters||Standard Deviation|Mean
89702|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. Overall change from Baseline to Week 26 in AHI. A greater decrease in events indicates a greater response.|Baseline to Week 26|||Events per hour||Standard Deviation|Mean
89703|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test (6MWT): Distance walked (measured in meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 26|||meters||Standard Deviation|Mean
89704|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity (FVC): the maximal exhaled breathe volume following a maximal inhaled breath. Overall Change from Baseline to Week 26 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 26|||Percent predicted FVC||Standard Deviation|Mean
89705|NCT00912912|Primary|12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate|Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.|12 weeks|||Percentage of Participants|||Number
89706|NCT00912808|Secondary|Frequency of Near Falls Per Day||2 weeks|||Number Near Falls/Day||Standard Error|Mean
89707|NCT00912808|Primary|Fall Frequency Per Day|The primary outcomes were fall and near-fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for one week of monitoring, and collected for six weeks per phase. Postcards were mailed back to the investigator weekly.|2 weeks|||Number Falls/Day||Standard Error|Mean
89708|NCT00912795|Secondary|Self-reported 30-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
89709|NCT00912795|Secondary|Self-reported 7-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
89710|NCT00912795|Secondary|CO-verified 7-day Point Prevalence Abstinence at 4 Weeks|self-reported continuous abstinence in the past 7 days at 4 weeks (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|4 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
89711|NCT00912795|Primary|Carbon Monoxide-verified Continuous Abstinence at 12 Weeks|self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|12-weeks post-quit day|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).||participants|||Number
89712|NCT00912782|Secondary|25-hydroxyvitamin D and Serum Calcium||10 weeks|||ng/mL||Standard Deviation|Mean
89713|NCT00912782|Primary|Arteriovenous Fistulae Maturation|Maturation of an AVF is the ability to stick the AVF with two large bore needles at ≥ 6 consecutive dialysis sessions, and achievement of an AVF blood flow >300 ml/min, assessed at six months following AVF creation.|6 months|||percentage of group|||Number
89714|NCT00912743|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death from any cause. In absence of death, the time is calculated from first dose till the date subject last known to be alive|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months|Full analysis set - all treated patients||days||95% Confidence Interval|Median
89715|NCT00912743|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients||days||95% Confidence Interval|Median
89716|NCT00912743|Primary|Tumour Response|Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients||Percentage of Participants||95% Confidence Interval|Number
89717|NCT00912509|Secondary|Time to Resolution of Stromal Infiltration||day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, week 3 (weekly assessment) until infiltrate is completely resolved||||||
89718|NCT00912509|Primary|Time to Re-epithelialization||Day 1, Day 2, Day 3, (daily assessment) after study treatment until re-epithelialization is complete|||Days||Inter-Quartile Range|Median
89848|NCT00911495|Primary|Safety as Measured by the Number of Participants With Adverse Events||28 days|All enrolled subjects were analyzed for safety.||participants|||Number
89719|NCT00912405|Secondary|Number of Sinuses With Significant Post-operative Adhesion Formation|Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.|30 days|||sinuses|Participants||Number
89720|NCT00912405|Secondary|Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities|Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.|Baseline and 30 days|||Pts. w/ significant IOP elevation|||Number
89721|NCT00912405|Primary|Device Placement Success Rate|A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.|At the time of procedure|||Sinuses|Participants||Number
89722|NCT00912405|Primary|Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)||30 days|||Number of Sinuses|Participants|95% Confidence Interval|Number
89723|NCT00912301|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|after 4 days' treatment|||percentage of the radio-labeled meal||Standard Deviation|Mean
89724|NCT00912301|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|after 4 days' treatment|||units on a scale||Standard Deviation|Mean
89725|NCT00912301|Secondary|Ascending Colon Emptying (AC t_1/2)||after 4 days' treatment|||hours||Standard Deviation|Mean
89726|NCT00912301|Secondary|Colonic Transit at 48 Hours (GC48)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment|||units on a scale||Standard Deviation|Mean
89727|NCT00912301|Primary|Colonic Geometric Center at 24 Hours (GC24)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment|||units on a scale||Standard Deviation|Mean
89728|NCT00912288|Secondary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence (including clinially important changes in clinical safety laboratory assessments, electrocardiograms and vital signs) in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study medication, including partial doses.||Participants|||Number
89729|NCT00912288|Secondary|Population Pharmacokinetic (PK) Analysis|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12||||||
89730|NCT00912288|Secondary|Euro Quality of Life - 5 Domain (EQ-5D) Assessment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Total possible score ranged from 5 to 15; lower score indicated a better health state.|Baseline, Weeks 12, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89731|NCT00912288|Secondary|Resource Utilization in Dementia-Lite Version (RUD-Lite)|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver’s job. Overall cost of care was evaluated to quantify resources utilized.|Baseline, Weeks 12, 18, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89732|NCT00912288|Secondary|Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores|Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) version of CIBIC-Plus was used to assess participant’s overall disease severity. The corresponding baseline assessment rated participant on 7-point scale: (1) extremely severe AD to (7) no symptoms of AD. Overall impression of change from baseline was rated on a 7-point scale: 1=marked improvement; 2=moderate improvement; 3=minimal improvement; 4=no change; 5=minimal worsening; 6=moderate worsening; 7=marked worsening; all assessments are relative to baseline. Higher score = worsening of global function.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89733|NCT00912288|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89734|NCT00912288|Secondary|Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer’s Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89735|NCT00912288|Secondary|Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89736|NCT00912288|Primary|Change From Baseline in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89737|NCT00912288|Primary|Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis(0-8), visuospatial ability(0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score = greater cognitive impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.|||||
89738|NCT00912223|Secondary|Serum Rituximab (RTX) Levels|RTX concentration levels within participants|Baseline, Days 28 and 365|Serum RTX concentrations were collected at baseline (n=57), day +28 (n=56), and day +365 (n=44) for a compliance rate of 92%, 90%, and 80% at the assigned time points.||ng/mL||Full Range|Median
89739|NCT00912223|Secondary|Incidence of Toxicities|Number of participants that experiences at least one grade 3 - 5 toxicity during the first two years, where grade 5 is worst.|Year 2|||participants|||Number
89740|NCT00912223|Secondary|Immunologic Reconstitution|Quantitative immunoglobulins (IgG)|Year 1|||mg/dL||Full Range|Median
89741|NCT00912223|Secondary|Quality of Life||Year 2|No data collected|||||
89742|NCT00912223|Secondary|Infections||Year 2|no data collected|||||
89743|NCT00912223|Secondary|Treatment-related Mortality (TRM)|The event is death occurring in patients in continuous complete remission. The TRM distribution will be estimated by the Kaplan-Meier curve.|Year 3|||percentage of participants||95% Confidence Interval|Number
89744|NCT00912223|Secondary|Overall Survival|The event is death from any cause.|Years 2 and 3|||percentage of participants||95% Confidence Interval|Number
89745|NCT00912223|Secondary|Chronic GVHD|The event is the incidence and severity of chronic GVHD from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval at two years post-transplant. Death prior to occurrence of chronic GVHD will be considered as a competing risk.|Year 2|||percentage of participants||95% Confidence Interval|Number
89746|NCT00912223|Secondary|Acute Graft-versus-Host Disease (GVHD)|The event is the incidence of grades II-IV acute GVHD from day of transplant, where grade IV is worst. The first day of acute GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that acute GVHD grade. GVHD should be monitored in accordance with BMT CTN manual of procedures guidelines.|Day 100|||percentage of participants||95% Confidence Interval|Number
89747|NCT00912223|Secondary|Time to Neutrophil Recovery|Neutrophil Recovery is defined as ANC > 500/mm^3 for 3 consecutive days.|Day 60|||days||Full Range|Median
89748|NCT00912223|Secondary|Donor Cell Engraftment|Donor engraftment is defined as > 5% donor peripheral blood T cell chimerism by Day +30 post-transplant in the setting of Absolute Neutrophil Count (ANC) recovery (ANC >500/mm^3 for 3 consecutive days).|Days 30 and 100|||percentage of donor T-cell chimerism||Full Range|Median
89749|NCT00912223|Secondary|Graft Failure|Primary graft failure is defined as a donor peripheral blood T cell chimerism < 5% at Day +30 post-transplant. Secondary Graft Failure is defined as documented engraftment followed by loss of graft as defined by donor peripheral blood T cell chimerism < 5%.|Day 30|||participants|||Number
89750|NCT00912223|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die, or if they relapse/progress or receive anti-lymphoma therapy not including planned post-transplant radiation.|Year 2|||percentage of participants||95% Confidence Interval|Number
89751|NCT00912158|Primary|Number of Patients Who Were Intubated|Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation|During ICU Stay|||participants|||Number
89752|NCT00912158|Secondary|Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality||Hospital stay||01/2010||||
89849|NCT00911443|Primary|Overall Tumor Response|Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response|1 year|||participants|||Number
89753|NCT00912093|Secondary|Time to Investigator-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
89754|NCT00912093|Secondary|Time to Subject-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
89755|NCT00912093|Secondary|Time to Almost Complete Symptom Relief|Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores <10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time.|Up to 120 Hours post treatment|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
89756|NCT00912093|Secondary|Time to Onset of Primary Symptom Relief|Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
89757|NCT00912093|Primary|Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient|Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.||Hours||95% Confidence Interval|Median
89758|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|Participants||Number
89759|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis was on those subjects who were enrolled, randomized to a study arm, and completed the study.||eyes|Participants||Number
89760|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those who are enrolled, randomized to a study arm, and completed the study.||eyes|Participants||Number
89761|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|||eyes|Participants||Number
89762|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study.||eyes|Participants||Number
89763|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis is on those subjects who were enrolled, randomized, and completed the study.||eyes|Participants||Number
89764|NCT00912015|Primary|Adverse Events: 12-months Safety Population|Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.|12 months|Patients who received the same dose for at least 350 days (12 months)||participants|||Number
89765|NCT00912002|Secondary|Number of Participants Who Discontinued the Study Due to An Adverse Event||Up to 14 days after study drug administration|All treated participants.||participants|||Number
89766|NCT00912002|Secondary|Number of Participants Who Experienced An Adverse Event||Up to 14 days after study drug administration|All treated participants.||participants|||Number
89767|NCT00912002|Primary|Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).|Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.|Up to 168 hours after study drug administration|All treated participants.||Percent Recovered||Standard Deviation|Mean
89768|NCT00911989|Primary|Proportion of Procedures Completed With Successful Endoscopic Visualization.|The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.|Assessed intra-operatively|All subjects on whom the surgery was attempted represent the primary analysis population.||participants|||Number
89769|NCT00911937|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
89770|NCT00911937|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
89771|NCT00911937|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Least Squares Mean
89772|NCT00911937|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
89773|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||mL||Standard Error|Least Squares Mean
89774|NCT00911937|Secondary|Mean Voided Volume Per Micturition|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||mL||Standard Deviation|Mean
89775|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||mL||Standard Error|Least Squares Mean
89776|NCT00911937|Secondary|Mean Voided Volume Per Nocturnal Micturition|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||milliliter (mL)||Standard Deviation|Mean
89777|NCT00911937|Secondary|Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Least Squares Mean
89778|NCT00911937|Secondary|Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
89779|NCT00911937|Secondary|Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Error|Least Squares Mean
89780|NCT00911937|Secondary|Nocturnal Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||units on a scale||Standard Deviation|Mean
89781|NCT00911937|Secondary|Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
89782|NCT00911937|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
89783|NCT00911937|Secondary|Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
89784|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
89785|NCT00911937|Secondary|Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
89786|NCT00911937|Secondary|Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
89787|NCT00911937|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
89788|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Error|Least Squares Mean
89789|NCT00911937|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Deviation|Mean
89790|NCT00911937|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
89791|NCT00911937|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Error|Least Squares Mean
89792|NCT00911937|Secondary|Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||micturitions per 24 hours||Standard Deviation|Mean
89793|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||percent change||Standard Deviation|Mean
89794|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.||episodes per 24 hours||Standard Error|Least Squares Mean
89795|NCT00911937|Primary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Error|Least Squares Mean
89850|NCT00911443|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from the randomization to progression or death|2 years|||months||95% Confidence Interval|Median
89796|NCT00911937|Primary|Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours|Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|Full analysis set (FAS): all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’(number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.||episodes per 24 hours||Standard Deviation|Mean
89797|NCT00911898|Primary|Maximum Tolerated Dose (MTD) or Maximum Feasible Dose|The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 – 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.|28 days|||mg/kg|||Number
89798|NCT00911898|Secondary|To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity||December 2011||||||
89799|NCT00911898|Secondary|To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)||December 2011||||||
89800|NCT00911859|Secondary|Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)|"Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) health and quality of life."|Baseline (Day 1 predose) and Cycle 9 (Week 54)|Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9||Scores on a scale||Standard Deviation|Mean
89801|NCT00911859|Secondary|Overall Survival|Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.|From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.||Days||95% Confidence Interval|Median
89802|NCT00911859|Secondary|1-year Survival Rate|Percentage of participants who are alive at the end of year 1 after randomization|1 year|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
89803|NCT00911859|Secondary|Duration of Response (DOR)|DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.|From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication|Included participants in the randomized population who achieved CR or PR.||Days||95% Confidence Interval|Median
89804|NCT00911859|Secondary|1-year Progression-Free Survival (PFS) Rate|The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.|1 year|Intent-to-treat (ITT) population: all randomized participants||Percentage of participants|||Number
89805|NCT00911859|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.|From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.||Days||95% Confidence Interval|Median
89806|NCT00911859|Secondary|Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria|sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.||Percentage of participants|||Number
89807|NCT00911859|Secondary|Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.||Percentage of participants|||Number
89808|NCT00911859|Primary|Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.||Percentage of participants|||Number
89809|NCT00911807|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry , Urinalysis, Electrocardiogram [ECG])||Baseline, week 4, 12, 16, 28||||||
89810|NCT00911807|Secondary|Combined Responders, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 28||||||
89811|NCT00911807|Secondary|Change From Baseline in Total Score for Neuropsychiatric Inventory (NPI)||week 16, 28||||||
89812|NCT00911807|Secondary|Change From Baseline for Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)||week 16, 28||||||
89813|NCT00911807|Secondary|Clinical Interview-based Impression of Severity (CIBIS+) Score||week 28||||||
89814|NCT00911807|Secondary|CIBIC+ Responders||week 4, 12, 16, 28||||||
89815|NCT00911807|Secondary|CIBIC+ Score||week 4, 12, 16||||||
89816|NCT00911807|Secondary|Change From Baseline for Original ADAS-COG||week 4, 12, 16, 28||||||
89817|NCT00911807|Secondary|ADAS-COG+ Responders||week 4, 12, 16, 28||||||
89818|NCT00911807|Secondary|Change From Baseline for ADAS-COG+||week 4, 12, 16||||||
89819|NCT00911807|Primary|Clinical Interview-based Impression of Change (CIBIC+) Score||week 28||||||
89820|NCT00911807|Primary|Change From Baseline in Alzheimer’s Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28|The ADAS-cog+ is a validated, widely used, 14 item psychometric instrument for testing cognitive functions with increased sensitivity in detecting changes in milder patients compared to the original ADAS-cog. It has a maximum score of 85 with a higher score indicating impairment and was assessed by a qualified neuropsychologist.|baseline and week 28|Analysis was intention to treat||points on a scale||Standard Deviation|Mean
89821|NCT00911768|Secondary|Unstimulated Salivary Flow Rates|Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.||ml/min||Standard Deviation|Mean
89822|NCT00911768|Secondary|Stimulated Salivary Flow Rates|Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.||ml/min||Standard Deviation|Mean
89823|NCT00911768|Primary|Visual Analogue Scale of Subjective Dry Mouth|Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.|8 weeks|Because primay outcome of the study was changes of Visual Analogue Scale of Subjective Dry Mouth between 0, 4 and 8 weeks, per protocol analysis was applied.||cm||Standard Deviation|Mean
89824|NCT00911742|Secondary|Tmax|Time to maximum plasma concentration|48 hours|||hours||Full Range|Median
89825|NCT00911742|Secondary|t1/2|Apparent terminal elimination half-life|48 hours|||hours||Standard Deviation|Mean
89826|NCT00911742|Primary|Cmax|Maximum plasma concentration|48 hours|||ng/mL||Standard Deviation|Mean
89827|NCT00911742|Primary|AUC (0-∞)|"The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0–t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R’2 (coefficient of determination). The units are ng.h/mL.~h=hours"|48 hours|||ng.h/mL||Standard Deviation|Mean
89828|NCT00911742|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measured concentration.~h=hour"|48 hours|||ng.h/mL||Standard Deviation|Mean
89829|NCT00911612|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|After 12-14 days' treatment|||units on a scale||Standard Error|Mean
89830|NCT00911612|Secondary|Colonic Transit, Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days' treatment|||units on a scale||Standard Error|Mean
89831|NCT00911612|Secondary|Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours|Colonic permeability is measured through differential excretion of urine saccharides. The subject ingests a methacrylate-coated capsule that contains saccharides (mannitol 1g and lactulose 5 g powder). The capsule provides a means to protect the sugars from absorption, until the sugars are delivered to the colon by means of a standard delayed release capsule. The value reported is the mean for each arm of the total amount of mannitol excreted over the 8-24 hour time period.|after 12-14 days' treatment|||mg||Standard Error|Mean
89832|NCT00911612|Primary|Ascending Colon Emptying T1/2|The half time for the ascending colon emptying (T1/2) was measured by the scintigraphic method. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule that is swallowed by the subject. Anterior and posterior gamma images are taken hourly. From the hourly scans, a time-activity curve is plotted using linear interpolation between time points when content was measured. The time taken to empty 50% of the isotope from the ascending colon is read from this time-activity curve.|After 12-14 days' treatment|||hours||Standard Error|Mean
89833|NCT00911612|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days treatment|||units on a scale||Standard Error|Mean
89834|NCT00911547|Secondary|Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only|"Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, Did you wake up with asthma symptoms? (no, once, more than once, awake “all night”), were assigned numerical values (0, 1, 2, 3, respectively).~The average score for the visit was determined by averaging the daily scores over all days between consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
89835|NCT00911547|Secondary|Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma|Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Liters/minute||95% Confidence Interval|Least Squares Mean
89836|NCT00911547|Secondary|Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use|Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
89837|NCT00911547|Primary|Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma|"The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.~The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
89838|NCT00911547|Primary|Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma|Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups|Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values were imputed. Data collected during discontinuation and unscheduled visits were included the analysis. Differences between treatments are evaluated based on LS means||Percentage of Change||95% Confidence Interval|Least Squares Mean
89839|NCT00911534|Other Pre-specified|Time to Achieve First 24-Hour Period Without Heartburn|Participants completed a daily symptom diary.|Baseline to Week 4|ITT||Days||Standard Error|Mean
89840|NCT00911534|Other Pre-specified|Percentage of Participants With Complete Heartburn Relief|Participants completed a daily symptom diary.|Week 2 and Week 4|ITT (n=number of participants with evaluable data)||Percentage of Participants|||Number
89841|NCT00911534|Primary|Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4|Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.|Week 4|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug (n=number of participants with evaluable data)||Percentage of Days||Standard Deviation|Mean
89842|NCT00911534|Secondary|Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4|Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.|Baseline and Week 4|ITT||Scores on a Scale||Standard Deviation|Mean
89843|NCT00911495|Secondary|Volume of the Peripheral Compartment||48 hours|||mL/kg||Standard Deviation|Mean
89844|NCT00911495|Secondary|Intercompartmental Clearance||48 hours|||mL/h/kg||Standard Deviation|Mean
89845|NCT00911495|Secondary|Volume of the Central Compartment||48 hours|||mL/kg||Standard Deviation|Mean
89846|NCT00911495|Other Pre-specified|Blood Flow and Biomarkers of Adhesion|As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity.|48 hours||||||
89852|NCT00911326|Secondary|Lymph Node Detection Rate|The rate of the subjects for whom Lymphoseek identified at least 1 sentinel lymph node. The detection rate point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek|||percentage of participants||95% Confidence Interval|Number
89853|NCT00911326|Secondary|Overall Accuracy|The overall accuracy is calculated as a percentage from the ratio of (true positives + true negatives) / (true positives + false negatives + true negatives). The overall accuracy point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek|||percentage of participants||95% Confidence Interval|Number
89854|NCT00911326|Secondary|Negative Predictive Value (NPV)|The NPV is calculated as a percentage from the ratio of true negatives to the sum of true negatives plus false negatives. The NPV point estimate was the observed rate and was made on a per-patient basis relative to patients predicted to be pathology-negative.|Surgery after injection of Lymphoseek|||% of participants predicted negative||95% Confidence Interval|Number
89855|NCT00911326|Primary|False Negative Rate (FNR)|The FNR is calculated as a percentage from the ratio of false negatives to the sum of true positives plus false negatives. The FNR point estimate was the observed rate and was made on a per-patient basis relative to patients with pathology-positive nodes.|Surgery after injection of Lymphoseek|||% of pathology-positive participants||95% Confidence Interval|Number
89856|NCT00911300|Secondary|Number of Participants Who Were Re-hospitalized|Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
89857|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm|Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
89858|NCT00911300|Secondary|Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE|Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF.|At second TEE (at Day 28+/-4)|mITT Population. Only clot-positive participants at the time of the first TEE were analyzed.||participants|||Number
89859|NCT00911300|Secondary|Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm|CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed.|Day 1 until Day 3|mITT Population. Only participants with data for primary successful electric cardioversion at the indicated timepoint were analyzed.||participants|||Number
89860|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
89861|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event|Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
89862|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause|The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
89883|NCT00911144|Secondary|Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)|Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||microgram per milliliter||95% Confidence Interval|Geometric Mean
89863|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism|Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
89864|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population||participants|||Number
89865|NCT00911300|Primary|Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants|Modified Intent-to-Treat (mITT) Population: all randomized participants receiving at least one dose of study medication and for whom any post-baseline value was available||participants|||Number
89866|NCT00911274|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
89867|NCT00911274|Primary|AUC0-inf - Area Under Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
89868|NCT00911274|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
89869|NCT00911170|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that - is fatal; - is life threatening (places the participant at immediate risk of death); - requires inpatient hospitalization or prolongation of existing hospitalization; - results in persistent or significant disability/incapacity; - is a congenital anomaly/birth defect; - other significant medical hazard. AEs were assessed for severity according to National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 3.0, based on this general guideline: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.|Approximately 8 weeks (4 treatment cycles)|Safety analysis set, defined as all participants in the Primary Analysis Set who received at least one dose of investigational product (IP; placebo or pegfilgrastim). One participant was randomized to the placebo arm but actually received pegfilgrastim and is included in the pegfilgrastim arm for the safety analyses.||participants|||Number
89870|NCT00911170|Secondary|Percentage of Participants With Grade 4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set||percentage of participants||95% Confidence Interval|Number
89871|NCT00911170|Secondary|Percentage of Participants With Grade 3/4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <1.0 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set||percentage of participants||95% Confidence Interval|Number
89872|NCT00911170|Secondary|Percentage of Participants With Grade 4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|"Grade 4 febrile neutropenia (FN) is defined as:~A temperature ≥ 38.0ºC (≥ 100.4ºF) and absolute neutrophil count (ANC) < 0.5 × 10^9/L, where ANC is measured the same day or within +/- 1 calendar day of a temperature ≥ 38.0ºC (≥ 100.4ºF), or~An ANC <0.5 × 10^9/L in combination with:~Documented sepsis or infection, OR~Neutropenia-related hospitalization where ANC is measured the same day or within +/- 1 calendar day."|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set||percentage of participants||95% Confidence Interval|Number
89884|NCT00911144|Secondary|Concentration of Antibodies Against Protein D (PD)|Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||ELISA units per milliliter||95% Confidence Interval|Geometric Mean
89916|NCT00910858|Secondary|Change From Baseline in Bone Marrow Cellularity and Correlation With Grade 4 Myelosuppression|Bone marrow cellularity is the volume ratio of hematopoietic stem cells and adipocytes (fat cells). Due to the small number of bone marrow samples, this analysis was not performed.|Baseline and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses.|||||
89873|NCT00911170|Secondary|Percentage of Participants With an Objective Response|The percentage of participants with a complete response (CR) or partial response (PR) defined by the RECIST v1.1 criteria at any time during the study. Response was be determined by the investigator’s assessment of radiographic scans. CR: Disappearance of all non-nodal target lesions and the disappearance of all non-nodal non-target lesions, and no new lesions. All nodal lesions must have reduction of short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters and no new lesions and/or unequivocal progression of existing non-target lesions, or, the disappearance of all non-nodal target lesions with persistence of one or more non-target lesion(s).|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set participants with measurable disease at Baseline.||percentage of participants||95% Confidence Interval|Number
89874|NCT00911170|Secondary|Time to Progression|Time from randomization to date of radiological disease progression calculated using the Kaplan-Meier method. Participants without progression were censored on the date of their last radiographic tumor assessment. Disease progression based on the investigator’s assessment of scans using the RECIST v1.1. Clinical progression without radiological assessment was not considered a disease progression. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set||months||95% Confidence Interval|Median
89875|NCT00911170|Secondary|Progression Free Survival|Time from randomization to date of radiological disease progression or death from any cause, whichever event occurs first, calculated using the Kaplan-Meier method. Participants without either event by the analysis data cutoff date were censored on the date of their last evaluable disease assessment. Disease progression based on the investigator’s assessment of radiographic scans using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Clinical progression without radiological assessment was not be considered a disease progression in this analysis. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set||months||95% Confidence Interval|Median
89876|NCT00911170|Secondary|Overall Survival|Median time from randomization to date of death caclulated using the Kaplan-Meier method. Participants were censored on the date of last contact (i.e., the date the participant was last known to be alive) if they were not known to have died.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set||months||95% Confidence Interval|Median
89877|NCT00911170|Primary|Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) < 1.0 × 10^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC < 1.0 × 10^9/L in combination with: – documented sepsis or infection, OR – neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|The primary analysis set which included all participants with a signed informed consent, and who were randomized and received at least 1 dose of protocol-specified study treatment (chemotherapy, bevacizumab, or investigational product).||percentage of participants||95% Confidence Interval|Number
89878|NCT00911157|Secondary|Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).|Safety Population: all participants who received at least one dose of medication (FPX or UFH).||percentage of participants|||Number
89879|NCT00911157|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10|Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS||points on a scale||Standard Deviation|Mean
89880|NCT00911157|Secondary|Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline|"Classifications of Improved, No change, or Worse were adjudicated blindly by the CIACE."|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS||percentage of participants|||Number
89881|NCT00911157|Secondary|Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE.|From Day 1 to Day 90 (±7 days)|FAS||percentage of participants|||Number
89882|NCT00911157|Primary|Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute symptomatic deep vein thrombosis (DVT)||percentage of participants|||Number
89885|NCT00911144|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||titer||95% Confidence Interval|Geometric Mean
89886|NCT00911144|Secondary|Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||microgram per milliliter||95% Confidence Interval|Geometric Mean
89887|NCT00911144|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.~Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||titer||95% Confidence Interval|Geometric Mean
89888|NCT00911144|Secondary|Concentration of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter.~Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.||microgram per milliliter||95% Confidence Interval|Geometric Mean
89889|NCT00911144|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After booster vaccination up to study end (Month 0 to Month 1)|||subjects|||Number
89890|NCT00911144|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|Within 31 days (Days 0 to 30) after booster vaccination|||subjects|||Number
89891|NCT00911144|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.|Within 4 days (Days 0 to 3) after booster vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
89892|NCT00911144|Primary|Number of Subjects Reporting Grade 3 Adverse Events|Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.|Within 31 days (Day 0 - Day 30) after booster vaccination.|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
89893|NCT00910988|Primary|Adipose Tissue Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||% change from basal to insulin phase||Standard Deviation|Mean
89894|NCT00910988|Primary|Peripheral Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||% change from basal to insulin phase||Standard Deviation|Mean
89895|NCT00910988|Primary|Hepatic Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||% change from basal to insulin phase||Standard Deviation|Mean
89896|NCT00910988|Primary|Whole Body Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.||mg/kg/min||Standard Deviation|Mean
89897|NCT00910910|Secondary|Number of Participants With Subsequent Anti-cancer Therapies Received Post Treatment|Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)|Up to data cut-off of 31 March 2014; up to approximately 53 months|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).||participants|||Number
89898|NCT00910910|Secondary|Time to Response|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|Intent to treat participants with an objective response as of 18 February 2013||weeks||Full Range|Median
89899|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|Intent to Treat population with an objective response as of 18 February 2013||weeks||95% Confidence Interval|Median
89900|NCT00910910|Secondary|Percentage of Participants With Overall Response Based on IWCLL Guidelines With a Later Cut-off of 31 March 2014|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:~Complete Remission (CR):~No lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~No circulating clonal B-lymphocytes~Platelets > 100,000/ul~Hemoglobin > 11.0 g/dl~Normocellular <30% lymphocytes, no B-lymphoid nodules;~Incomplete Clinical Response (CRi):~• CR without bone marrow biopsy confirmation.~Nodular Partial Response:~• CR with the presence of residual clonal nodules.~Partial Response requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul"|Up to data cut-off of 31 March 2014; approximately 53 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not||percentage of participants with response|||Number
89901|NCT00910910|Secondary|Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia Guidelines (IWCLL) Guidelines|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:~Complete Remission (CR):~No lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~No circulating clonal B-lymphocytes~Platelets > 100,000/ul~Hemoglobin > 11.0 g/dl~Normocellular <30% lymphocytes, no B-lymphoid nodules;~Incomplete Clinical Response (CRi):~• CR without bone marrow biopsy confirmation.~Nodular Partial Response (nPR):~• CR with the presence of residual clonal nodules.~Partial Response (PR) requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul"|Up to data cut-off of 18 Feb 2013; approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||percentage of participants|||Number
89902|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator’s assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression|Data cut-off of 18 Feb 2013; up to approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||months||95% Confidence Interval|Median
89903|NCT00910910|Secondary|Euro Quality of Life Five Dimension (EQ-5D) Questionnaire|The standardized extended version of EQ-5D was designed for the collection of health state values using a visual analogue scale (VAS) rating scale - a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.|Day 1 and once every 8 weeks|No data were collected for the EQ-5D QOL assessment.EQ-5D analysis was not conducted due to the discontinuation of the Lenalidomide arm|||||
89904|NCT00910910|Secondary|Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument|The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).|Day 1 and once every 8 weeks|No data were collected for the FACT-Leu QOL assessment. Analysis not conducted due to the discontinuation of the Lenalidomide arm|||||
89905|NCT00910910|Secondary|Kaplan Meier Estimate of Overall Survival for a Later Cut-off of 31 March 2014|Overall Survival is defined as the time between randomization and death from any cause.|Up to data cut off of 31 March 2014; up to approximately 53 months; median follow-up was 18.8 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||Months||95% Confidence Interval|Median
89906|NCT00910910|Secondary|Kaplan Meier Estimate for Overall Survival|Overall Survival is defined as the time between randomization and death from any cause..|Up to data cut off of 18 Feb 2013; up to approximately 39 months;|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not as of 18 February 2013.||Months||95% Confidence Interval|Median
89907|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off of 31 March 2014|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator’s assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.|Data cut-off of 31 March 2014; up to approximately 53 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.||months||95% Confidence Interval|Median
89908|NCT00910910|Secondary|Time to Response for a Later Cut-off of 31 March 2014|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 31 March 2014; up to approximately 53 months|Intent to Treat participants with an objective response||weeks||Full Range|Median
89909|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response With a Later Cut-off of 31 March 2014|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 31 March 2014; up to approximately 53 months|Intent to Treat participants with an objective response||weeks||95% Confidence Interval|Median
89910|NCT00910910|Secondary|Number of Participants With Adverse Events (AEs) With a Later Cut-off of 31 March 2014|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization to the data cut-off of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).||participants|||Number
89911|NCT00910910|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil) as of the data cut off date of 18 Feb 2013||participants|||Number
89912|NCT00910871|Secondary|The Percentage of Participants With Sputum Culture Conversion|The table below shows the percentage of participants who were responders to treatment. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued or died during the trial were considered non-responders.|Week 120|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.||Percentage of Participants|||Number
89913|NCT00910871|Primary|The Median Time to Sputum Culture Conversion|The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube [MGIT]).|Up to Week 24|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.||Days||95% Confidence Interval|Median
89914|NCT00910858|Secondary|Marrow-infiltrating Lymphocyte (MIL) Number and Cytolytic Activity|Due to the low number of bone marrow samples collected this analysis was not performed.|Pre-Study and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses|||||
89915|NCT00910858|Primary|Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
89917|NCT00910858|Secondary|Percentage of Participants Overall With Erythroid Response by Baseline Erythropoietin Level|To evaluate the predictive value of pretreatment serum erythropoietin (EPO) concentration for erythroid response to lenalidomide, the percentage of erythroid responders versus non-responders were stratified by Baseline EPO levels (≤ 500 mIU/mL versus > 500 mIU/mL). Response includes participants with either a major or minor response.|Assessed every 28 days until study discontinuation (up to 1218 days)|Safety population.||percentage of participants|||Number
89918|NCT00910858|Secondary|Percentage of Participants With a Erythroid Response Across All Phases|Erythroid response was categorized as either a major response or a minor response. A major response was defined as red blood cell (RBC) transfusion independence during any consecutive 56-day period and an increase in hemoglobin of at least 1.5 g/dL. A minor response was defined as a ≥ 50% or ≥ 4 unit decrease in RBC transfusions from pretreatment requirements (the number of RBC transfusions required over an 8-week period before the start of study drug treatment).|Assessed every 28 days until study discontinuation (up to 1218 days).|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.||percentage of participants|||Number
89919|NCT00910858|Secondary|Time to Grade 4 Neutropenia or Thrombocytopenia|Time to the first event of grade 4 neutropenia or thrombocytopenia, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, was calculated as date of first event - date of first dose + 1.|From the date of first dose until 30 days after the last dose (up to 1218 days)|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.||days||Full Range|Median
89920|NCT00910858|Secondary|Monotherapy Phase: Percent of Lenalidomide Excreted Over 5 Hours Post Day 14 Dose|"Percent of the administered lenalidomide dose excreted unchanged in urine over 5 hours postdose after multiple dosing for 14 days, calculated as:~(amount excreted unchanged in urine over the first 5 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day 14, at predose and over the interval of 0-5 hours postdose.|Monotherapy Phase Pharmacokinetic Population.||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
89921|NCT00910858|Secondary|PK Phase: Percent of Administered Lenalidomide Excreted Over 24 Hours After a Single, Oral Dose|"Percent of the administered dose of lenalidomide excreted unchanged in urine over 24 hours postdose after a single dose on Day -7, calculated as:~(amount excreted unchanged in urine over 24 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day -7 at predose and over the intervals of 0-5, 5-8, 8-12, and 12-24 hours postdose.|PK Phase participants for whom data was available.||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
89922|NCT00910858|Secondary|PK Phase: Terminal Half-life (t1/2)|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|Pharmacokinetic Phase participants.||hours||Geometric Coefficient of Variation|Geometric Mean
89923|NCT00910858|Secondary|Monotherapy Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The Maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
89924|NCT00910858|Secondary|PK Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after a single dose on day -7.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|All Pharmacokinetic Phase participants||ng/mL||Geometric Coefficient of Variation|Geometric Mean
89925|NCT00910858|Primary|PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.|All Pharmacokinetic Phase participants.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
89926|NCT00910845|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||milliliters||Standard Deviation|Mean
89927|NCT00910845|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||micturition episodes||Standard Deviation|Mean
89928|NCT00910845|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||Incontinence episodes||Standard Deviation|Mean
89942|NCT00910624|Primary|Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24);|SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks)|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."||percentage of participants|||Number
89929|NCT00910715|Secondary|Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.|"6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week.~For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe)."|6 months after treatment|number of participants with nonspecific symptoms||number of participants|||Number
89930|NCT00910715|Primary|Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.|At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.|1 year follow-up|Number of participants with complete response to treatment.||number of participants|||Number
89931|NCT00910689|Secondary|Change in Quality of Life at Month 16|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Scores on a scale||95% Confidence Interval|Mean
89932|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 16|Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary.|Change form Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of Days||95% Confidence Interval|Mean
89933|NCT00910689|Secondary|Change in Number of Migraine Episodes Per 30 Days at Month 16.|Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of Migraine Episodes||95% Confidence Interval|Mean
89934|NCT00910689|Secondary|Change in Quality of Life at Month 10|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Scores on a scale||95% Confidence Interval|Mean
89935|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 10|Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of days||95% Confidence Interval|Mean
89936|NCT00910689|Primary|Change in Number of Migraine Episodes Per 30 Days at Month 10.|Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.||Number of Migraine episodes||95% Confidence Interval|Mean
89937|NCT00910663|Primary|AUC0-t|Bioequivalence based on AUC0-t - Area under concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
89938|NCT00910663|Primary|AUC0-inf|Bioequivalence based on AUC0-inf - Area under concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
89939|NCT00910663|Primary|Cmax|Bioequivalence based on Cmax - Maximum Drug Concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
89940|NCT00910624|Secondary|Percentage of Participants With Early Virologic Response (EVR)|EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From TW 1 to TW 12|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."||percentage of participants|||Number
89941|NCT00910624|Primary|Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL|AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks)|All Treated Participants: All enrolled participants who received at least one dose of treatment.||percentage of participants|||Number
90098|NCT00909545|Secondary|Common Adverse Events: Hypotension|Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
89943|NCT00910520|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||milliliters||Standard Deviation|Mean
89944|NCT00910520|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||micturition episodes||Standard Deviation|Mean
89945|NCT00910520|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.||Incontinence episodes||Standard Deviation|Mean
89946|NCT00910299|Secondary|Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of all-cause death or MI.|Baseline through 6 months|Participants who were randomized.||participants|||Number
89947|NCT00910299|Secondary|Number of Participants With Stent Thrombosis (ST)|Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.|Baseline through 6 months|Participants who were randomized.||participants|||Number
89948|NCT00910299|Primary|Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of cardiovascular death or MI.|Baseline through 6 months|Participants who were randomized.||participants|||Number
89949|NCT00910273|Secondary|Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52|Chest expansion defined as the difference in thoracic circumference during full expiration versus full inspiration, measured in cm at the fourth intercostal space (nipple line) while participant was standing. Measurement taken twice and best of the two measurements (corresponding to the highest value of inspiration and smallest value for expiration), were then averaged. Greater chest circumference indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||cm||Standard Deviation|Mean
89950|NCT00910273|Secondary|Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52|While participant stood with back against the wall and during maximal effort to touch head to the wall, the distance between the occiput (back of head) and the wall was measured. The measurement of two attempts was made and best of the two measurements which corresponds to the highest value were reported. Lower scores indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
89951|NCT00910273|Secondary|Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between participant's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
89952|NCT00910273|Secondary|Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between the tragus and wall from the right and left side while participant was standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in a neutral position. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the smallest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
89953|NCT00910273|Secondary|Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between marks originally placed while participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joins the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bent forward, knees fully extended, with supine in full flexion. The measurement was carried out two times and best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
90099|NCT00909545|Secondary|Common Adverse Events: Back Pain|Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
89954|NCT00910273|Secondary|Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of the distance between the medial malleoli when participant was lying supine with knees straight and feet pointed straight up with legs separated as far as possible, 2 attempts were measured. The best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point||cm||Standard Deviation|Mean
89955|NCT00910273|Secondary|Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52|While in a neutral position, the participant turned the head as far as possible to the right and then to the left. Using a goniometer the degrees of movement were measured. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Actual rotation ranged from 3.0 to 99.0 degrees. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, 52 or ET|mITT; n= number of participants evaluable at specific time point||degrees of movement||Standard Deviation|Mean
89956|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Lower score indicated better spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point||Units on a scale||Standard Deviation|Mean
89957|NCT00910273|Secondary|Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52|Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
89958|NCT00910273|Secondary|Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
89959|NCT00910273|Secondary|Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
89960|NCT00910273|Secondary|Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants with evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
89961|NCT00910273|Secondary|Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
89962|NCT00910273|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change greater than or equal to (≥) 10 units on a 0-100 millimeter (mm) scale (0 mm = no disease activity; 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
89963|NCT00910273|Secondary|Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52|BASDAI a validated self assessment tool used to determine disease activity in participants with AS. Utilizing a VAS of 0 (none) to 10 cm (very severe), participant's answered 6 questions measuring discomfort, pain and fatigue. BASDAI 50 response defined as at least a 50% improvement (decrease) from baseline in BASDAI. Baseline score – score at observation divided by Baseline score * 100 = greater than or equal to 50%.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point||percentage of participants|||Number
90100|NCT00909545|Secondary|Common Adverse Events: Sinusitis|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
89964|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52|BASDAI a validated self assessment tool to determine disease activity in participant with Ankylosing Spondylitis (AS) using a Visual Analog Scale (VAS) of 0 (none) to 10 (very severe) centimeter (cm). Participant answered 6 questions measuring discomfort, pain and fatigue. Final BASDAI score averages the individual assessments for a final score range of 0-10. Change: Week x observation minus Baseline observation. Higher score indicates greater disability. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, and 52 or ET|mITT; n= number of participants evaluable at specific time point||Units on a scale||Standard Deviation|Mean
89965|NCT00910273|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52|CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point||mg/liter (mg/L)||Standard Deviation|Mean
89966|NCT00910273|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour (hr). A higher rate is consistent with inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point||mm/hr||Standard Deviation|Mean
89967|NCT00910273|Secondary|Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52|Mean serum homocysteine blood concentrations. Lower values of homocysteine indicate improvement in inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; N=number of participants evaluable||micromole/liter (µmol/L)||Standard Deviation|Mean
89968|NCT00910273|Secondary|Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and Triglyceride (TGL) blood concentrations, lower values indicated improvement in cardiovascular risk. Mean High Density Lipoprotein (HDL), higher values indicated improvement in cardiovascular risk. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable||millimole/Liter (mmol/L)||Standard Deviation|Mean
89969|NCT00910273|Secondary|Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52|Change in IMT in the distal common carotid arteries (CCA), common bulbs (CB), and internal carotid arteries (ICA) as determined by ultrasound. Higher scores indicate worsening in cardiovascular risk assessment. Change: Week x observation minus Baseline observation.|Baseline, Week 12 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable||mm||Standard Deviation|Mean
89970|NCT00910273|Secondary|Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52|BA FMD =(maximum diameter -baseline diameter divided by baseline diameter) * 100%. Ultrasound images of BA at rest were followed by BP cuff inflated to at least 50 mm Hg above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. Change: Week x observation minus Baseline observation.|Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)|mITT; n=number of participants evaluable at specific time point||percentage of BA diameter||Standard Deviation|Mean
89971|NCT00910273|Primary|Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12|Brachial artery (BA) FMD equals (=)(maximum diameter minus[-] baseline diameter divided by baseline diameter) times (*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.|Baseline, Week 12|Modified Intent to Treat Population (mITT): all randomized participants who received at least one dose of test article followed by at least one available evaluation; n=number of participants evaluable at specific time point||percentage of BA diameter||Standard Deviation|Mean
89972|NCT00910091|Secondary|Progression Free Survival (PFS): Time From Randomisation Until Objective Tumour Progression or Death From Any Cause||Up to 2 years|||Weeks||90% Confidence Interval|Median
89973|NCT00910091|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause.|At 2 years|ITT population.||Weeks||90% Confidence Interval|Median
89974|NCT00910091|Secondary|Duration of Response (DR) in Responders|DR is defined as period from the time that measurement criteria are first met for CR or PR until first date of documented Progressive Disease (PD) or death. DR was assessed in participants with a best overall response of CR or PR.|At 2 years|ITT population.||Weeks||90% Confidence Interval|Median
89975|NCT00910091|Secondary|Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation||Up to 2 years|ITT population.||Percentage of Participants||Standard Deviation|Mean
89976|NCT00910091|Secondary|Percentage of Participants With Overall Response (OR) Including CR and PR||Up to 2 years|ITT population.||Percentage of Participants||Standard Deviation|Mean
90101|NCT00909545|Secondary|Common Adverse Events: Diarrhoea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90102|NCT00909545|Secondary|Common Adverse Events: Dyspepsia|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
89977|NCT00910091|Secondary|Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks|"CR: Disappearance of all known disease & no new sites / disease related symptoms confirmed at least 12 weeks after initial documentation. Disappearance of all non-target lesions. Normalization of tumor marker level confirmed at least 12 weeks after initial documentation.~PR: Minimum 30% decrease in sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 12 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Up to 2 years|ITT population.||Percentage of Participants||Standard Deviation|Mean
89978|NCT00910091|Secondary|Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is a participant answered questionnaire scoring 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Up to week 32|"ITT population.~Three subjects withdrawn the consent from MA 160 mg group and did not have EuroQoL score up to week 32."||Percentage of participants|||Number
89979|NCT00910091|Secondary|Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions|Percentage of participants who had dose interruptions and reason for interruptions as AE, study treatment forgotten, and other reasons.|Up to 2 years|Safety Population||Percentage of participants|||Number
89980|NCT00910091|Secondary|Tolerability of BN83495 Based on Cumulative Dose Administered|Cumulative dose is the actual total dose administered.|Up to 2 years|"Safety Population~Missing number of subjects = 2"||mg||Standard Deviation|Mean
89981|NCT00910091|Secondary|Tolerability of BN83495 Based on Length of Exposure|Length of exposure includes interruptions.|Up to 2 years|Safety Population||Week||Standard Deviation|Mean
89982|NCT00910091|Secondary|Percentage of Participants With Adverse Event (AE)|Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening/disabling and Grade 5: Death|Up to Day 28 follow-up|Safety Population: All randomised subjects who received at least one dose of study medication.||Percentage of subjects|||Number
89983|NCT00910091|Primary|Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died|Subject continuation in the study and Response Evaluation Criteria in Solid Tumours (RECIST) assessment has been based on investigator assessment and not on central review. The 6 month timepoint is defined as the treatment start date +183 days (26 weeks).|Up to 6 months|Intent-to-treat (ITT) population includes all randomized subjects who received at least one dose of study medication.||Percentage of subjects||90% Confidence Interval|Number
89984|NCT00910039|Secondary|Safety and Tolerability|Number of patients that experienced treatment-related G 3-4 adverse events.|3 years from study start|||participants|||Number
89985|NCT00910039|Secondary|Neurocognitive Effects|The number of patients that had statistically significant change (p’s > 0.05) in their neurocognitive assessment (improvement or decline) from baseline. Neurocognitive function was assessed in several domains, including memory, verbal fluency, visual-motor speed, executive function and motor dexterity.The difference between the pre-treatment baseline and follow-up assessment scores were determined by the reliable change (RC) index. RC Index: 1=deterioration, 2=no change, 3=improved|at 2 months after treatment|Due to the small number of patients accrued there was not enough data for analysis of this outcome.|||||
89986|NCT00910039|Secondary|Rate of Local Failure at 12 Months|Rate of local vs regional failure –rates of progression at site of stereotactic radiosurgery (local failure)vs progression anywhere else in CNS (regional failure).|12 months|Due to the small number of patients accrued there was not enough data for analysis of this outcome.|||||
89987|NCT00910039|Secondary|Time to Progression|Time to progression (all sites of disease) - interval between stereotactic radiosurgery and the earliest date of progression (systemic or CNS) or death due to any cause.|at 3 yrs from SRS|||months||95% Confidence Interval|Median
89988|NCT00910039|Secondary|Overall Survival|The number of subjects surviving at least 12 months from stereotactic radiosurgery.|12 months from SRS|Intent to treat||participants|||Number
89989|NCT00910039|Secondary|Median Time to CNS Disease Progression|Time to disease progression will be recorded from the first day of protocol therapy until the criteria for disease progression are met, patient death from any cause or removal of the patient from study for any reason, whichever comes first.|up to12 months from SRS|Intent to treat||months||95% Confidence Interval|Median
89990|NCT00910039|Secondary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least 12 months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald’s standard criteria. Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|12 months after stereotactic radiosurgery (SRS)|Intent to treat||participants|||Number
89991|NCT00910039|Primary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least six months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald’s standard criteria.Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|6 months after stereotactic radiosurgery (SRS)|Intent to treat||participants|||Number
90020|NCT00909857|Secondary|Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
89992|NCT00910000|Secondary|Response|Response was based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD from the smallest LD recorded on treatment. Stable disease (SD) is neither sufficient increase to qualify as PD nor sufficient shrinkage to qualify for PR. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed 4 weeks +/- 2 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Participants who received therapy but did not have their disease re-evaluated were considered unevaluable.|Disease was assessed radiographically (CT or MRI scan) every 2 cycles on treatment; Phase Ib participants received up to 8 cycles of treatment. The median number of cycles started was 2 (range 1-8).|||participants|||Number
89993|NCT00910000|Primary|Dose Limiting Toxicity (DLT) [Phase Ib]|"Dose-limiting toxicity was based on the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) and defined as any of the following:~Any CTCAE grade 3 or 4 non-hematologic event except manageable gastrointestinal toxicity and fatigue.~Any of the following hematologic events (excluding neutropenia lasting < 5 days):~i) febrile neutropenia defined as grade 3-4 neutropenia with fever ≥ 38.5°C and/or infection.~ii) any grade 4 neutropenia lasting 5 days or more. iii) grade 4 thrombocytopenia (plt count < 25x 109/L) iv) failure of ANC to recover to ≥ 1000/μL or platelets to recover to ≥ 50,000/μL within 14 days of therapy v) grade 4 anemia~Any clinically significant abnormal laboratory value that results in dose delay of >14 days.~<75% of vorinostat dosing taken by the patient during the first cycle due to any toxicity."|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, DLT evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final DLT dataset was comprised of all enrolled and treated participants.||participants with DLT|||Number
89994|NCT00910000|Primary|Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]|The Vorinostat MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, MTD evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final MTD dataset was comprised of all enrolled and treated participants.||mg/day|||Number
89995|NCT00909870|Other Pre-specified|Complete Healing by Week 16: Ulcers <= 12 Months Duration||16 weeks|Pre-specified Subgroup of the Intent-to-Treat Population||participants|||Number
89996|NCT00909870|Secondary|Time-to-Complete Healing|Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.|From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject’s ulcer not healed at 16 weeks, the “time until CH” was censored at 112 days.|Intent-to-Treat population||days||Inter-Quartile Range|Median
89997|NCT00909870|Primary|Complete Healing of the Study Ulcer by Week 16.||16 weeks|Intent-to-Treat population||participants|||Number
89998|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
89999|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90000|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90001|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90002|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90003|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90004|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90005|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90006|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90007|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90008|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90009|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants wit assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90021|NCT00909857|Secondary|Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90010|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90011|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90012|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|at final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90013|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90014|NCT00909857|Secondary|Participants With Improvement in Participants' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Participants were asked to rate their improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Participants|||Number
90015|NCT00909857|Secondary|Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Investigators were asked to rate the participants' improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Participants|||Number
90016|NCT00909857|Secondary|Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90017|NCT00909857|Secondary|Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90018|NCT00909857|Secondary|Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90019|NCT00909857|Secondary|Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90022|NCT00909857|Secondary|Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90023|NCT00909857|Secondary|Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90024|NCT00909857|Secondary|Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Dollars||Full Range|Median
90025|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
90026|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
90027|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At Baseline (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
90028|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At screening (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available||Percentage of Participants|||Number
90029|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of participants|||Number
90030|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of participants|||Number
90031|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90032|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90033|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90034|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90035|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
90036|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
90037|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
90038|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
90039|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90103|NCT00909545|Secondary|Common Adverse Events: Insomnia|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90040|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90041|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90042|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90043|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90044|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90045|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
90046|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of Participants|||Number
90047|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Spotting Only Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90074|NCT00909779|Secondary|The Incidence of Protocol Defined COPD Exacerbations.|A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
90048|NCT00909857|Secondary|Maximum Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90049|NCT00909857|Secondary|Mean Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90050|NCT00909857|Secondary|Number of Episodes With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
90051|NCT00909857|Secondary|Number of Days With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90052|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90053|NCT00909857|Secondary|Maximum Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90054|NCT00909857|Secondary|Mean Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90072|NCT00909779|Secondary|The Incidence of Treatment Emergent AEs|"TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date.~The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated."|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||participants|||Number
90055|NCT00909857|Secondary|Number of Episodes With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Episodes||Standard Deviation|Mean
90056|NCT00909857|Secondary|Number of Days With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90057|NCT00909857|Secondary|Percentage of Participants Satisfied With Study Treatment|Participants were asked to express the degree of their satisfaction with study treatment.|From cycle 1 to cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Percentage of participants|||Number
90058|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available||Percentage of Participants|||Number
90059|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available||Percentage of participants|||Number
90060|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Tablets||Standard Deviation|Mean
90061|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Tablets||Standard Deviation|Mean
90062|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding|Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90063|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding|Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90064|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain|Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
90065|NCT00909857|Primary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain|Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure||Days||Standard Deviation|Mean
90066|NCT00909792|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.||logMAR||Standard Deviation|Mean
90067|NCT00909779|Secondary|Inspiratory Capacity (IC): Mean Change From Baseline|"IC: the total amount of air that can be drawn into the lungs after normal expiration.~IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline."|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Least Squares Mean
90068|NCT00909779|Secondary|Forced Vital Capacity (FVC): Mean Change From Baseline|Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Least Squares Mean
90069|NCT00909779|Secondary|Percent Predicted FEV1: Mean Change From Baseline|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1."|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Least Squares Mean
90070|NCT00909779|Secondary|FEV1: Mean Change From Baseline|FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Liter||Standard Error|Mean
90071|NCT00909779|Secondary|SGRQ: Mean Change From Baseline in Total Score|The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer’s guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.|Baseline and on treatment at months 3, 6 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Score||Standard Error|Least Squares Mean
90093|NCT00909610|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90075|NCT00909779|Primary|Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).|COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit > 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a ‘probable cause’, which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered ‘UNKNOWN’. Cause other than ‘UNKNOWN’ was categorized as either respiratory or non-respiratory. Deaths of ‘UNKNOWN’ cause were counted as primary events.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.||Days|Participants|Standard Deviation|Mean
90076|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
90077|NCT00909753|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90078|NCT00909753|Primary|AUC0-72 for Total Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
90079|NCT00909753|Primary|Cmax for Total Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90080|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
90081|NCT00909753|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90082|NCT00909753|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
90083|NCT00909753|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90084|NCT00909727|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||kilograms||Standard Error|Least Squares Mean
90085|NCT00909727|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||millimoles per liter||Standard Error|Least Squares Mean
90086|NCT00909727|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Through Week 24 and Week 48 (Respiratory Domain Score, Children)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||score on a scale||Standard Error|Least Squares Mean
90087|NCT00909727|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||percent of predicted volume (L)||Standard Error|Least Squares Mean
90088|NCT00909727|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo)and had available assessments during the time frame.||percent of predicted volume (L)||Standard Error|Least Squares Mean
90089|NCT00909649|Primary|Seroma Formation|the mean total drainage volume|within 30 days postoperative|ITT||ml||Standard Deviation|Mean
90090|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
90091|NCT00909610|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90092|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
90104|NCT00909545|Secondary|Common Adverse Events: Somnolence|Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90105|NCT00909545|Secondary|Common Adverse Events: Depression|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90106|NCT00909545|Secondary|Common Adverse Events: Upper Respiratory Tract Infection|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90107|NCT00909545|Secondary|Common Adverse Events: Nausea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90108|NCT00909545|Secondary|Common Adverse Events: Fatigue|General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90109|NCT00909545|Secondary|Common Adverse Events: Constipation|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90110|NCT00909545|Secondary|Common Adverse Events: Headache|Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90111|NCT00909545|Secondary|Common Adverse Events: Nasopharyngitis|Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90112|NCT00909545|Secondary|Common Adverse Events: Dizziness|Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90113|NCT00909545|Secondary|Common Adverse Events: Oedema Peripheral|General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90114|NCT00909545|Secondary|Vital Signs: Change in Pulse Supine||Baseline to 12 months or the time to require dopaminergic therapy|||beats per minute||Standard Error|Least Squares Mean
90115|NCT00909545|Secondary|Vital Signs: Change in Pulse Standing||Baseline to 12 months or the time to require dopaminergic therapy|||beats per minute||Standard Error|Least Squares Mean
90116|NCT00909545|Secondary|Vital Signs: Change in Diastolic Supine||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
90117|NCT00909545|Secondary|Vital Signs: Change in Diastolic Standing||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
90118|NCT00909545|Secondary|Vital Signs: Change in Systolic Supine||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
90119|NCT00909545|Secondary|Vital Signs: Change in Systolic Standing||Baseline to 12 months or the time to require dopaminergic therapy|||mm Hg||Standard Error|Least Squares Mean
90120|NCT00909545|Secondary|Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)|The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90121|NCT00909545|Secondary|Efficacy: Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90122|NCT00909545|Secondary|Efficacy: Change in Beck Depression Inventory II (BDI-II)|The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90132|NCT00909532|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..||millimoles per liter||Standard Error|Least Squares Mean
90123|NCT00909545|Secondary|Efficacy: Change in Modified Schwab & England Independence Scale|The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability).|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90124|NCT00909545|Secondary|Efficacy: Change in Modified Hoehn & Yahr Scale|The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90125|NCT00909545|Secondary|Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90126|NCT00909545|Secondary|Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in the primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90127|NCT00909545|Secondary|Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were used in primary and secondary outcome analyses||units on a scale||Standard Error|Least Squares Mean
90128|NCT00909545|Primary|Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.|Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group.|Baseline to 12 months or the time to require dopaminergic therapy|||participants|||Number
90129|NCT00909545|Secondary|Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|Participants are 99 subjects with early Parkinson disease not requiring dopaminergic therapy.||Scores on a scale||Standard Error|Least Squares Mean
90130|NCT00909532|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||kilograms||Standard Error|Least Squares Mean
90131|NCT00909532|Secondary|Time-to-first Pulmonary Exacerbation Through Week 24 and Week 48|Pulmonary exacerbation was defined as a change in antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of signs/symptoms such as change in sputum; new or increased hemoptysis; increased cough or dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees C; anorexia or weight loss; sinus pain/tenderness and discharge; change in physical examination of the chest; decreased pulmonary function by 10%; and radiographic changes indicative of pulmonary infection.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||proportion of event-free participants||95% Confidence Interval|Number
90133|NCT00909532|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score Through Week 24 and Week 48 (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||score on a scale||Standard Error|Least Squares Mean
90134|NCT00909532|Secondary|Absolute Mean Change From Baseline in Percent Predicted FEV1 Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..||percent of predicted volume (L)||Standard Error|Least Squares Mean
90135|NCT00909532|Primary|Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.||percent of predicted volume (L)||Standard Error|Least Squares Mean
90136|NCT00909480|Secondary|"Number of Subjects Having the Adverse Event Incorrect Dose Administered"|"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications"|Weeks 0-26|Safety Analysis Set: All subjects that received at least one dose of the trial product.||Subjects|||Number
90137|NCT00909480|Secondary|Change in Body Weight From Baseline||Week 0, Week 26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||kg||Standard Deviation|Mean
90138|NCT00909480|Secondary|Hypoglycemic Episodes, Unclassifiable|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
90139|NCT00909480|Secondary|Hypoglycaemic Episodes, Nocturnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
90140|NCT00909480|Secondary|Hypoglycaemic Episodes, Diurnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
90141|NCT00909480|Secondary|Incidence of Hypoglycaemic Episodes During the Trial|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
90142|NCT00909480|Secondary|Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)|Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||mmol/L||Standard Deviation|Mean
90143|NCT00909480|Secondary|Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast|The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||mmol/L||Standard Deviation|Median
90144|NCT00909480|Secondary|Fasting Plasma Glucose (FPG)||Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||mmol/L||Standard Deviation|Mean
90145|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage (%) of subjects|||Number
90146|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%|The percentage of subjects – overall and by previous OAD treatment – meeting the HbA1c of 6.5% or less|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage (%) of subjects|||Number
90147|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage (%) of subjects|||Number
90148|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%|The percentage of subjects – overall and by previous OAD treatment – meeting the HbA1c less than or equal to 7%|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage of subjects|||Number
90149|NCT00909480|Primary|Change in HbA1c From Baseline||Week 0, Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.||percentage point change||Standard Deviation|Mean
90165|NCT00908960|Secondary|To Investigate the Safety of Prophylactic Enoxaparin in Cancer Patients (Major Bleeding Episodes).||2 months||||||
90150|NCT00909389|Primary|Number of Participants Who Had an Adverse Event (AE).|"The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia.~All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE."|Throughout study up to Day 29 (Final Visit)|||participants|||Number
90151|NCT00909324|Secondary|Change in the Results of Schirmer’s Test From Baseline to End of Study|Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.||mm||Standard Deviation|Mean
90152|NCT00909324|Secondary|Change in Tear Breakup Time From Baseline to End of Study|The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.||Seconds||Standard Deviation|Mean
90153|NCT00909324|Primary|Change in Ocular Comfort Level From Baseline to End of Study|Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.||Units on a scale||Standard Deviation|Mean
90154|NCT00909181|Primary|Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12|Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.|12 weeks|mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment||Episodes||Standard Deviation|Mean
90155|NCT00909155|Secondary|Vitals||each visit||||||
90156|NCT00909155|Primary|Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task.||At study entry, 2 months and end of study (6 months)||||||
90157|NCT00909155|Primary|Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales|"Hamilton Depression rating scale is a clinician assessment tool to measure severity of depression symptoms. Minimum score is 0 (no symptoms); maximum score is 52 (severe symptoms of depression).~Hamilton Anxiety rating scale is a clinician assessment tool to measure severity of anxiety symptoms. Minimum score is 0 (no symptoms); maximum score is 56 (severe symptoms of anxiety)."|Study entry, 2 months, and at end of study (6 mos)|||units on a scale||Standard Deviation|Mean
90158|NCT00909038|Secondary|Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007|The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.|Baseline to a minimum of 8 weeks of treatment|Per protocol set (PPS)||percentage of patients|||Number
90159|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mmHg||Standard Deviation|Mean
90160|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mmHg||Standard Deviation|Mean
90161|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mm Hg||Standard Deviation|Mean
90162|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||mm Hg||Standard Deviation|Mean
90163|NCT00909038|Primary|Rate of BP Control in Hypertensive Patients|"Percentage of controlled Patients at the Study End.~Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines."|Baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.||Percentage of Participants||95% Confidence Interval|Number
90164|NCT00908960|Secondary|To Assess the Impact of Enoxaparin on Overall Survival.||years||||||
90166|NCT00908960|Primary|The Cumulative Incidence of VTE at 2 Months.|The cumulative incidence of VTE at 2 months in the higher Venous thromboembolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP).|2 months|All patients enrolled who underwent randomization and evaluation for baseline VTE.||Cumulative probability of having VTE||95% Confidence Interval|Number
90167|NCT00908908|Primary|Pharmacokinetics AUC (0-t) for Eribulin in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population||ng eq*hr/mL/mg||Standard Deviation|Mean
90168|NCT00908908|Primary|Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population||ng eq*hr/mL/mg||Standard Deviation|Mean
90169|NCT00908908|Primary|Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.||312 hours postdose|Pharmacokinetic Population||percent recovery||Standard Deviation|Mean
90170|NCT00908895|Secondary|Range of Movement of Wrist|"Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.~Motion is described as a percentage of the opposite side."|6 months|||Percentage of opposite side||95% Confidence Interval|Mean
90171|NCT00908895|Primary|The Grip Strength|Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.|6 months|No participant changed to the other group. Patients lost or with complications were not analyzed||Percentage of opposite side||95% Confidence Interval|Mean
90172|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 6-month follow-up period|These numbers represent those who completed the survey.||units on a scale||Standard Deviation|Mean
90173|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 90-session intervention period|These numbers represent those that completed the survey.||units on a scale||Standard Deviation|Mean
90174|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At the end of the 6-month follow-up period|These numbers represent those that completed the survey.||units on a scale||Standard Deviation|Mean
90175|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At end of 90-session intervention period|These numbers represent those that completed the survey.||units on a scale||Standard Deviation|Mean
90176|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Are you currently a smoker?~Yes, I currently smoke (move to For Smokers Only section)~No, I quit within the last 6 months (ACTION STAGE)~No, I quit more than 6 months ago (MAINTENANCE STAGE)~No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?~(For smokers only) Are you seriously thinking of quitting smoking?~Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)~Yes, within the next 6 months (CONTEMPLATION STAGE)~No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During the 6-month follow-up period|||participants|||Number
90177|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During the 6-month follow-up period|||participants|||Number
90178|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During the 6-month follow-up period|||participants|||Number
90179|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During 90-session intervention period|||participants|||Number
90180|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Transtheoretical Model of Change questionnaire:~Are you currently a smoker?~Yes, I currently smoke (move to For Smokers Only section)~No, I quit within the last 6 months (ACTION STAGE)~No, I quit more than 6 months ago (MAINTENANCE STAGE)~No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?~(For smokers only) Are you seriously thinking of quitting smoking?~Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)~Yes, within the next 6 months (CONTEMPLATION STAGE)~No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During 90-session intervention period|||participants|||Number
90181|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During 90-session intervention period|||participants|||Number
90182|NCT00908687|Other Pre-specified|Cross-clade HI Antibody Titer Measurement: Compare the Heterologous HI Antibody Responses to the A/Indonesia/05/2005 (Clade 2.1) Strain of the H5N1 Virus.||6 months||||||
90183|NCT00908687|Other Pre-specified|Adjuvanticity Evaluation: Compare HI Immune Responses Achieved by Antigen and Adjuvant Combinations With Antigen Alone Groups.||6 months||||||
90184|NCT00908687|Secondary|Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity|"The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40%~The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70%~Geometric mean titer (GMT) fold increase > 2.5"|Day 28||||||
90185|NCT00908687|Secondary|Safety of a 100μg LT Patch||6 months||||||
90186|NCT00908687|Secondary|Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch||6 months||||||
90217|NCT00908128|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
90187|NCT00908687|Primary|Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.|Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40.|Day 28|Primary Immunogenicity Evaluable Population (PIEP): all subjects who were consented, randomized, received the assigned treatment, had HI assay results at all the following time points: baseline (Day 0), Day 21 and Day 28, and did not have any major protocol deviations||percentage of subjects||95% Confidence Interval|Number
90188|NCT00908648|Secondary|Detection of Flat and/or Depressed Adenomas|number of patients with at least 1 flat and/or depressed adenoma|duration of colonoscopy procedure|||participants|||Number
90189|NCT00908648|Primary|Adenoma Detection|Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization|duration of colonoscopy procedure|||participants|||Number
90190|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Characterization|The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
90191|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Delineation|The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
90192|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Detection|The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
90193|NCT00908596|Secondary|Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)|The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
90194|NCT00908596|Secondary|Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score|Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
90195|NCT00908596|Primary|Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information|A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist||Participants|||Number
90196|NCT00908583|Secondary|Acute Rejection Rate|Acute rejection rate at 6 months of all desensitized and transplanted patients|6 months post transplant|One graft loss occurred due to graft thrombosis within 24 hours (due to unrecognized hypercoagulability disorder without AMR). Two patients were transplanted at other centers and data was not available. This dropped the number of analyzed patients to 16 from 19.||participants|||Number
90197|NCT00908583|Secondary|Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%|Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%.|46 days|||participants|||Number
90198|NCT00908583|Primary|Number of Living Donor Transplant Candidates That Are Transplanted|Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted|1 year post baseline|||participants|||Number
90199|NCT00908583|Secondary|Overall Safety of Bortezomib|Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD).|Study Day 62|||participants|||Number
90200|NCT00908388|Primary|Exclusion of Primary Entry Tear|Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery|1 month|||participants|||Number
90201|NCT00908388|Secondary|Additional Dissection Based Intervention Rate|Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.|Last available follow-up through 2 years|||participants|||Number
90202|NCT00908388|Secondary|Aortic Rupture||Last available follow-up through 2 years|||participants|||Number
90203|NCT00908388|Secondary|False Lumen Thrombosis|Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.|Last available follow-up through 2 years|Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis||participants|||Number
90204|NCT00908388|Primary|All-cause Mortality Incidence Through 30 Days Post-treatment||30 Days Post-Treatment|All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.||participants|||Number
90218|NCT00908128|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
90205|NCT00908375|Secondary|Oswestry Disability Questionnaires|"Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the percent disability. There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks."|3 weeks|||percent disability||Full Range|Median
90206|NCT00908375|Secondary|Patient's Global Impression of Change at 3 Weeks|"Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:~Very Much Improved~Much Improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse"|3 weeks|||units on a scale||Full Range|Median
90207|NCT00908375|Primary|Pain Scores (NRS) at 3-weeks|Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.|3 weeks|||units on a scale||Full Range|Median
90208|NCT00908310|Primary|Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).|Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.|Greater than or equal to 7 days post contrast administration.|Incidence of Nephrogenic Systemic Fibrosis (NSF)||percentage of subjects||95% Confidence Interval|Number
90209|NCT00908232|Secondary|Overall Survival|Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy. Further follow up by monthly phone call until the last patient was treated and followed for 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
90210|NCT00908232|Secondary|One Year Survival|Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||percent probability||95% Confidence Interval|Number
90211|NCT00908232|Secondary|Time to Progression|Is calculated as the time from start of treatment to the date of the first observation of disease progression or relapse from CR. Deaths owing to causes other than progression not counted, but censored. Subjects who withdraw from the study or die will be censored at the time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), Median Follow-up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
90212|NCT00908232|Secondary|Progression Free Survival|"Time from start of treatment to date of disease progression, relapse from CR or death. Estimated using the kaplan-meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR). Median Follow-Up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
90213|NCT00908232|Secondary|Median Time to First Confirmed Response|Time from start of treatment to the date of the first documentation of a confirmed response. Estimated using the Kaplan-Meier method. Response was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).||days||95% Confidence Interval|Median
90214|NCT00908232|Primary|Overall Best Confirmed Response|Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19). Data are missing for 21 patients in the non-randomized CR/PR group, n=123.||number of participants|||Number
90215|NCT00908141|Primary|Prostate Specific Antigen (PSA) Response|The number of patients with PSA modulation defined as PSA decline of at least 50%|post treatment at 9 weeks|||participants|||Number
90216|NCT00908128|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
90219|NCT00908115|Primary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) following vaccination.|||Subjects|||Number
90220|NCT00908115|Primary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include induration, itching, pain, redness, and swelling.~Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting."|During the 4-week follow-up period after each dose|Analysis was performed on the subjects who received the considered dose.||Subjects|||Number
90221|NCT00908115|Primary|Number of Subjects Reporting Serious Adverse Events|"A serious adverse event is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Since the beginning of the study and during the entire study period (up to 6 years)|||Subjects|||Number
90222|NCT00908076|Primary|Change From Baseline to End of Study|Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student’s t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.|Baseline to end of study|"A marked or very marked clinical global improvement.~Ondo WG et al. Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease. Neurology 2012 May 22; 78:1650. - See more at: http://www.jwatch.org/jn201205290000006/2012/05/29/lubiprostone-constipation-parkinson-disease#sthash.ggWrS7Vq.dpuf"||percentage of subjects improved|||Number
90223|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Number of participants with a change in visual acuity and change in visual acuity due to the worsening of cataracts since Baseline are presented for Part 2/3 Follow-up Visits at 3-months (FU3) and 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|BL, 3 and 6mo Follow-up of Part 2/3|Safety Population: all subjects who have received at least one dose of the investigational product during Part 2/3 were analyzed.||Participants|||Number
90224|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|Baseline, 3and 6-mo Follow-up of Part 1|Safety Population: all subjects who have received at least one dose of the investigational product during Part 1 were analyzed.||Participants|||Number
90225|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 31 of Part2/3|Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed||Participants|||Number
90226|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 7 of Part 2|Safety Population: all participants who received at least one dose of the investigational product during Part 2 were analyzed.||Participants|||Number
90227|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 24 of Part1|Safety Population: all participants who received at least one dose of the investigational product during Part 1 were analyzed.||Participants|||Number
90261|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)|Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count >=50 Gi/L during treatment with eltrombopag in >= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.|Between Day 15 and Day 43 of Part 2|Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.||Percentage of Participants|||Number
90267|NCT00907907|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
90228|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 2/3 up to Study Week 31|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population||Participants|||Number
90229|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.|Baseline and Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population||Participants|||Number
90230|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.||Participants|||Number
90231|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.||Beats per minute||Standard Deviation|Mean
90232|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Beats per minute||Standard Deviation|Mean
90233|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline (MPB) visit included any scheduled and unscheduled post-Baseline assessment..|From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population||Beats per minute||Standard Deviation|Mean
90262|NCT00908037|Primary|Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)|Participants who achieved a platelet count >=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.|From Day 8 up to Day 43 of Part 2|Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count >10Gi/L was considered as evaluable.||Percentage of Participants|||Number
90234|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Breaths per minute||Standard Deviation|Mean
90235|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population||Breaths per min||Standard Deviation|Mean
90236|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Baseline through Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population .||Breaths per min||Standard Deviation|Mean
90237|NCT00908037|Secondary|Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3|Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: <85, 85-115, >115; for Cohort 2: <85, 85-120,>120; and Cohort 3: <95, 95-135, >135. RR for DBP (mmHg) for Cohort 1: <45, 45-70,>70; for Cohort 2: <50, 50-75, >75; and Cohort 3: <55, 55-85, >85.|From Baseline through Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
90238|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline and post-Baseline up to Study Week 31 of Part 2/3|Safety Population, only those participants enrolled during Part 2/3 were analyzed.||Participants|||Number
90239|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline and post-Baseline up to Study Week 7 of Part 2|Safety Population, only those participants enrolled during Part 2 were analyzed.||Participants|||Number
90240|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline up to Study Week 24 of Part 1|Safety Population, only those participants enrolled during Part 1 were analyzed.||Participants|||Number
90263|NCT00908011|Secondary|Assessment of Safety Parameters, Specifically Incidence of Complications as Measured by an Increase in AST &/or ALT ≥3-fold ULN & a CK ≥10-fold ULN||3 months from baseline||||||
90264|NCT00908011|Secondary|Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein||3 months from baseline||||||
90268|NCT00907907|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg/mL||Standard Deviation|Mean
90241|NCT00908037|Secondary|Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute [ ml/min]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles [mg/mmol]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
90242|NCT00908037|Secondary|Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Hematology parameters included: erythrocytes (RR: 4.2 - 6.1 teragrams per liter [TI/L]), hemoglobin (RR: 125 - 165 g/L), hematocrit (RR: 0.36 - 0.46), platelets (RR: 170 - 430 gigagrams per liter [GI/L]), mean platelet volume (MPV, RR: 4 - 14 femotoliter [fL]), leukocytes (RR: 3.4 - 11.2 GI/L), total neutrophils (RR: 2.1 - 4.9 GI/L), lymphocytes (RR: 1.4 - 2.9 GI/L), monocytes (RR: 0.2 - 0.9 GI/L), eosinophils (RR: 0.2 - 0.7 GI/L), and basophils (RR: 0.02 - 0.12 GI/L). Baseline values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
90243|NCT00908037|Secondary|Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Clinical chemistry parameters included: aspartate amino transferase (AST, reference range [RR]: 0-38 International Units per Liter [IU/L]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles [umol]/L), albumin grams [g/L], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles [mmol]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
90244|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline of Part 2/3 through Follow-up|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
90245|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline through Week 7 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
90246|NCT00908037|Secondary|Kids’ ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1=never, 2=seldom, 3=sometimes, 4=often, 5=always and 9=not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|From Baseline to end of treatment up to Study Week 31|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Score on scale||Standard Deviation|Mean
90335|NCT00907088|Secondary|Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.||Age 24 months||||||
90247|NCT00908037|Secondary|Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline and Week 6 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Score on scale||Standard Deviation|Mean
90248|NCT00908037|Secondary|Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline, Week 6, Week 12, and Week 24 of Part 1|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Score on scale||Standard Deviation|Mean
90249|NCT00908037|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.||Participants|||Number
90250|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3|Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.|From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.||Percentage of Participants|||Number
90251|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.|The participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 1 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 1 Day 1 to the last dose of study medication + 1 day.|From Baseline up to Week 24+ 1 day of Part 1|ITT Population, only those participants enrolled during Part 1 were analyzed.||Percentage of Participants|||Number
90252|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2/3. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline up to Study Week 31|ITT Population only those participants enrolled in Part 2/3 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2/3.||Weeks||Full Range|Median
90265|NCT00908011|Primary|The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.||3 months from baseline|||mmol/L||Standard Deviation|Mean
90266|NCT00907907|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.||µg*hr/mL||Standard Deviation|Mean
90253|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count|From Baseline through Week 7 of Part 2|ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.||Weeks||Full Range|Median
90254|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3|The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
90255|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3|The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||hour (hr)||Full Range|Median
90256|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.|The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
90257|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3.|The area under the concentration-time curve over the dosing interval (AUC0-t) data was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. From the final model, a single value of AUC(0-t) was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.||Microgram*hour per milliliter (ug*h/mL)||95% Confidence Interval|Geometric Mean
90258|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment during Part 2/3 of the study were reported. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|Part 2/3 up to Study Week 31|ITT Population. Only evaluable participants were included for this analysis, where participants with a baseline platelet count >10 Gi/L was considered as evaluable.||Percentage of Participants|||Number
90259|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.|From Day 1 of treatment up to Week 24 of Part 1|ITT Population only those participants enrolled during Part 1 were analyzed.||Percentage of Participants|||Number
90260|NCT00908037|Secondary|Weighted Mean Platelet Count|The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.|Baseline and Day 43 of Part 2|ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis||Gi/L||Standard Deviation|Mean
90336|NCT00907088|Primary|The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.||Age 24 months|||participants|||Number
90269|NCT00907881|Secondary|Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12|Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases.|Baseline and Week 12|All enrolled participants with available data at both Baseline and Week 12.||Correlation coefficient|||Number
90270|NCT00907881|Secondary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)|Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12|||Correlation coefficient|||Number
90271|NCT00907881|Secondary|Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)|Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.||Score on a scale||Standard Deviation|Mean
90272|NCT00907881|Primary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores|Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.||Correlation coefficient||95% Confidence Interval|Number
90273|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 14|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 21 and 20 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ).||hours||Standard Deviation|Mean
90274|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 5 and 6 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).||ng*hr/mL||Standard Deviation|Mean
90275|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 23 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ) before the 24-hour dosing interval was complete.||ng*hr/mL||Standard Deviation|Mean
90276|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 and 5 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).||hours||Standard Deviation|Mean
90277|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.||hours||Standard Deviation|Mean
90278|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).||ng/mL||Standard Deviation|Mean
90279|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.||ng/mL||Standard Deviation|Mean
90280|NCT00907803|Primary|Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.|Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.|Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose|As per protocol. During the study, a total of 6 withdrawals occurred. These were due to adverse events (2) and consent withdrawal (1) in the 400 mg group, and subject request (1), lost to follow-up (1) and protocol violation (1) in the 600 mg group.||Participants|||Number
90337|NCT00906971|Primary|Retentive Fecal Incontinence.|"Retentive fecal incontinence is the lose of fecal while the patient tries to avoid the bowel movement.~The patients (or their parents) received a bowel diary and they fulfilled about frequency of episodes of retentive fecal incontinence weekly."|six weeks|||days/week||Standard Deviation|Mean
90281|NCT00907777|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.|Throughout the entire study period (approximately 1 month per subject)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
90282|NCT00907777|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within 31 days (Day 0-30) post-additional vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
90283|NCT00907777|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
90284|NCT00907777|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited general symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.||Subjects|||Number
90285|NCT00907777|Secondary|Anti-protein D Antibody Concentrations|The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
90286|NCT00907777|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||Titers||95% Confidence Interval|Geometric Mean
90287|NCT00907777|Secondary|Cross-reactive Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||microgram/milliliter||95% Confidence Interval|Geometric Mean
90288|NCT00907777|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||Titers||95% Confidence Interval|Geometric Mean
90289|NCT00907777|Primary|Vaccine Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.||microgram/milliliter||95% Confidence Interval|Geometric Mean
90290|NCT00907738|Primary|Percent of Participants With a Serious Drug-related Adverse Event (AE)|"A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.~A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug."|From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)|||percent of participants|||Number
90291|NCT00907621|Secondary|Parents Evaluation of Benefit to the Child.|"Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well.~The numbers are the actual evaluations on the time specified."|5 days, 1 , and 4 weeks after the first treatment|The differences in numbers on parents evaluation of the childs condition (37 and 38) is due to one location assistant not reporting back on these results. Thus the number of interviews, 84, and secondary outcome data is not consistent with the numbers in the flow diagram.||units on a scale||Standard Deviation|Mean
90292|NCT00907621|Primary|Change in Crying Time Per 24 Hour Period.|Crying time per 24 hour period at baseline and post treatment|6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.|||minutes crying time pr 24 hour||95% Confidence Interval|Mean
90338|NCT00906971|Primary|Frequency of Defecation.|The patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.|six weeks|||days/week||Standard Deviation|Mean
90293|NCT00907517|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who discontinued study treatment due to an AE is summarized.|Up to 135 days|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
90294|NCT00907517|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who experienced an AE is summarized.|Up to 45 days after last dose of study treatment (Up to 180 days)|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
90295|NCT00907517|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number of participants who experienced a DLT during Cycle 1 is summarized.|Throughout Cycle 1 (Up to 6 weeks)|The population consisted of all participants who received at least one dose of study treatment.||Participants|||Number
90296|NCT00907478|Secondary|Number of Participants Who Developed Antibodies or Neutralizing Antibodies to Romiplostim or to Endogenous Thrombopoietin|"Two validated assays were used to test for antibodies to romiplostim, the thrombopoietin-mimetic peptide component of romiplostim (TMP) and to endogenous thrombopoietin (TPO). The first was an immunoassay to confirm the presence of antibodies. The second was a cell-based bioassay to detect neutralizing or inhibitory effects in vitro. If a sample was positive in both assays, a participant was defined as positive for neutralizing antibodies.~Persistent antibodies were those positive at the last timepoint tested and transient are defined as positive post-dose but negative at the last time point tested."|Every 24 weeks and at the end of study visit (4 weeks or 12 weeks after study drug discontinuation).|All participants who received at least one dose of romiplostim.||participants|||Number
90297|NCT00907478|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant that did not necessarily have a causal relationship with this treatment, or any such occurrence or worsening of a pre-existing medical condition from the first dose of investigational product through the last study visit. A serious adverse event is defined as an AE that is fatal or life threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. The relationship of each AE to the study drug was assessed by the investigator. The severity of each AE was graded using using CTCAE 3.0; For any AEs not listed in CTCAE, the Amgen Standard Severity Scoring System was used: 1: Mild- Aware of sign or symptom, but easily tolerated; 2 Moderate- Discomfort enough to cause interference with usual activity; 3: Severe- Incapacitating with inability to work or do usual activity; 4: Life-threatening; 5: Fatal.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim||participants|||Number
90298|NCT00907478|Secondary|Percentage of Participants With CTCAE Grade ≥ 2 Shift in Anemia or Neutropenia|Anemia was identified by laboratory values with hemoglobin < the lower limit of normal (LLN) or the Medical Dictionary for Regulatory Activities (MedDRA) terms prespecified by the sponsor. Neutropenia was identified by laboratory values with absolute neutrophil count <1.8x10^9/L or the MedDRA terms pre-specified by the sponsor. Severity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, based on the following: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim||percentage of participants||95% Confidence Interval|Number
90299|NCT00907478|Secondary|Number of Participants With Improvement of Reticulin to a Grade of ≤ 2 for Participants Who Developed Grade 3 Reticulin|The number of participants who had any improvement of reticulin to a grade of ≤ 2 for participants who developed grade 3 reticulin after initial exposure to romiplostim as measured by the modified Bauermeister grading scale. The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|12 weeks after romiplostim discontinuation|Participants with Grade 3 reticulin at Year 1, 2 or 3 and who had a follow-up bone marrow biopsy 12 weeks after romiplostim discontinuation. Two participants with grade 3 reticulin did not have a bone marrow biopsy performed 12 weeks after romiploastim discontinuation.||participants|||Number
90300|NCT00907478|Secondary|Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals|A clinically relevant change in QTc (Fridericia) interval is defined as an absolute QTc interval >500 ms or a QTc Interval increase from Baseline >60 ms post romiplostim exposure. 12-lead electrocardiograms (ECG) were performed in triplicate at Baseline, Week 3 and Week 12; the average of of the 3 values at each assessment was used.|Baseline, Week 3 and Week 12|All participants who received at least one dose of romiplostim.||percentage of participants||95% Confidence Interval|Number
90301|NCT00907478|Secondary|Percentage of Participants Who Developed an Increased Modified Bauermeister Grade|Increased modified Bauermeister grade refers to an increase by ≥ 2 severity grades or an increase to grade 4 (ie, grade 0 to 2-4, grade 1 to 3-4, grade 2 to 4, or grade 3 to 4 over baseline). The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|At Year 1, Year 2, or Year 3 post romiplostim exposure|Participants who had evaluable reticulin silver stain results||percentage of participants||95% Confidence Interval|Number
90302|NCT00907478|Secondary|Number of Participants With Collagen Fibrosis 12 Weeks After Romiplostim Discontinuation in Participants Who Developed Collagen Fibrosis at Years 1, 2, or 3|The number of participants with collagen fibrosis as evidenced by trichrome staining 12 weeks after romiplostim discontinuation in participants who developed collagen fibrosis at Years 1, 2, or 3 after initial exposure of romiplostim, assessed by the central laboratory using the modified Bauermeister grading scale.|12 weeks after romiplostim discontinuation|Participants with collagen fibrosis at Year 1, 2 or 3 and with available trichome staining results 12 weeks after study drug discontinuation. One participant with collagen fibrosis refused the follow-up bone marrow biopsy.||participants|||Number
90303|NCT00907478|Primary|Percentage of Participants With Collagen Fibrosis|The percentage of participants who developed collagen fibrosis as evidenced by trichrome staining. Bone marrow biopsy samples were assessed using the modified Bauermeister grading scale by a central laboratory.|At Years 1, 2 or 3 after initial exposure of romiplostim|Participants who had evaluable trichrome stain results||percentage of participants||95% Confidence Interval|Number
90304|NCT00907426|Other Pre-specified|Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4|Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Percentage of Participants|||Number
90305|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Darkness at Month 4|Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Eyelash Intensity Units||Standard Deviation|Mean
90306|NCT00907426|Secondary|Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4|Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Millimeters squared (mm^2)||Standard Deviation|Mean
90307|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Length at Month 4|Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure||Millimeters (mm)||Standard Deviation|Mean
90308|NCT00907426|Primary|Percentage of Treatment Responders at Month 4|Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.|Month 4|Intent-to-Treat: All randomized subjects||Percentage of Subjects|||Number
90309|NCT00907374|Secondary|Endothelial Dysfunction|Post hyperemia increase in blood flow - fold increase from before and after occluding BP; values are mean of all participants in 6-36 months of study period.|6 to 36 months|complerters||Fold increase||Standard Deviation|Mean
90310|NCT00907374|Secondary|Carotid Artery Intima Thickness|Thickness of intima of right carotid artery; average of all particpants from 6-36 months of study|6 to 36 months|Completers||mm||Standard Deviation|Mean
90311|NCT00907374|Secondary|Estimated Glomerular Filtration Rate|This is an average for all participants during the 3-36 month study period|3 to 36 months|Completers||ml/min/1.73 meters squared||Standard Deviation|Mean
90312|NCT00907374|Primary|Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio|Average of ratio for all participants during the 3-36 months of the study|3 to 36 months|||Ratio||Standard Deviation|Mean
90313|NCT00907335|Secondary|Global Assessment|Participants showing improvement from baseline in the Investigator’s Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject’s improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.|Baseline to Week 12|||Participants|||Number
90314|NCT00907335|Secondary|Measurement of Success 3|Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject’s improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of “Excellent” or “Good” scores.|Week 12|||Participants|||Number
90315|NCT00907335|Secondary|Measurement of Success 2|Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12|||Participants|||Number
90316|NCT00907335|Secondary|Measurement of Success 1|Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12|||Participants|||Number
90317|NCT00907335|Secondary|Change From Baseline in Lesion Counts|Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12|||Lesions||Standard Error|Least Squares Mean
90318|NCT00907335|Primary|Change From Baseline in Total Non-inflammatory Lesion Count|Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12|||Lesions||Standard Error|Least Squares Mean
90319|NCT00907257|Secondary|Measurement of Success|"Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:~0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe."|Baseline to Week 12|Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)||Participants|||Number
90320|NCT00907257|Secondary|Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals|Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).|Baseline to Week 12|Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).||Lesions||Standard Error|Least Squares Mean
90321|NCT00907257|Primary|Change From Baseline in Total Facial Acne Lesion Count|Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.|Baseline to Week 12|Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations.||Lesions||Standard Error|Least Squares Mean
90322|NCT00907218|Secondary|Spontaneous Reports of Adverse Effects|0|Weekly for 7 weeks||||||
90323|NCT00907218|Secondary|Vital Signs|0|Weekly for 7 weeks||||||
90324|NCT00907218|Secondary|The CGI-I and CGI-S for ADHD|0|Weekly for 7 weeks||||||
90325|NCT00907218|Secondary|Rates of Smoking Cessation|0|Weekly for 7 weeks||||||
90326|NCT00907218|Secondary|Exhaled CO Levels|0|Weekly over 7 weeks||||||
90327|NCT00907218|Primary|Time Line Follow Back of Cigarette Smoking|0|Weekly for 7 weeks||||||
90328|NCT00907218|Primary|The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)||Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed|||||
90329|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Stinging/Burning|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
90330|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
90331|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
90332|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4|||participants|||Number
90333|NCT00907101|Primary|Change From Baseline in Quantitative Bacteriology Measurements at Week 4|Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².|Week 4|||log10 CFU/cm2||Standard Deviation|Mean
90334|NCT00907088|Secondary|IDA (Hemoglobin < 110 g/L With Iron Deficiency)||Age 24 months||||||
90339|NCT00906789|Secondary|Sensitivity and Specificity Using SoftView Software|Sensitivity and specificity were calculated using the radiologists' responses of recommendations for follow-up with CT or biopsy. Truth was whether or not the nodule identified was found to be cancer. Sensitivity is the percentage of correct identification of a positive case (a case with cancer). Specificity is the percentage of negative cases (those without cancer) that were correctly identified as not having cancer. The mean values of 15 radiologists are used.|Three days of experiment over 3-5 months, varied by participant|||percentage of cases||95% Confidence Interval|Mean
90340|NCT00906789|Other Pre-specified|Difference in the Area Under the LROC Curve Comparing OnGuard 1.0 and OnGuard 5.1|This reports the comparison of the detection of lung nodules that were proven to represent lung cancers. It compares the results of two versions of computer-aided detection software: OnGuard 1.0 from 2001 and OnGuard 5.1 from 2009. The results represent the responses of radiologists when they use one or the other types of software. To compare radiologists' results with the two types of software, the measurement analyzed was the difference in the areas under the localized receiver operating characteristic curve (LROC). The results from the 15 participating radiologists were averaged (mean value). The area under the LROC curve is a measure of the trade-offs between sensitivity and 1-specificity that occurs as the level of certainty of a positive finding changes. It is normally reported as a decimal without units. In this study dsign, a lower number indicates that the new method (OnGuard 5.1), if statistically significant, if better.|5 months|81 of the 263 radiographs contained a non-calcified nodule that had been diagnosed as lung cancer. Power calculation showed 246 patients, in a 2:1 ratio of nodule absent to present would provide 80% power to detect a difference in areas under the curve of 0.10 or greater.||unitless|Participants|95% Confidence Interval|Mean
90341|NCT00906789|Primary|Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.|"Standard methods for LROC methodology and statistical analysis were used. We are testing two different types of software using different cases, but the same radiologists to control for radiologist differences. LROC is Localized Receiver Operating Characteristic. LROC measures the trade-offs between sensitivity and specificity as radiologists use different levels of suspicion of disease. This analysis is for the software that decreases the visibility of the ribs and clavicles while preserving (and potentially enhancing) the visibility of the lungs and lung diseases. In this case, the level of suspicion recorded was for the radiologist's concern that a finding did or did not represent cancer. Please note that the FDA approved indications for use is to detected nodules that may represent cancer, but in our study scoring for a true finding was based on whether or not the nodule did represent cancer.~A larger number, if statistically significant, indicates that that method is better."|Three days of experiment over 3-5 months, varied by participant|122 subjects had cancer that potentially could be detected on their chest radiograph. Power analysis showed that sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater.||unitless|Participants|95% Confidence Interval|Mean
90342|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 12 months|||mm||Standard Deviation|Mean
90343|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 6 months|||mm||Standard Deviation|Mean
90344|NCT00906776|Secondary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 6 months|||mm||Standard Deviation|Mean
90345|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 12 months|||millimeters||Standard Deviation|Mean
90346|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 6 months|||mm||Standard Deviation|Mean
90347|NCT00906776|Primary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 12 months|||millimeters||Standard Deviation|Mean
90348|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
90349|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
90350|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90351|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90352|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
90353|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h,, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
90354|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
90355|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||hours||Full Range|Median
90356|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90357|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90358|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
90359|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
90360|NCT00906698|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study medication to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0. Median time results from unstratified Kaplan-Meier estimates.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 44 months.|All patients treated in the MTD cohorts.||weeks||Inter-Quartile Range|Median
90361|NCT00906698|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size was the best percentage change in the sum of diameters of target lesions and was calculated as (minimum sum of diameters post baseline - sum of diameters at baseline)/sum of diameters at baseline. Negative values indicate a decrease, positive values an increase.|Screening and every 8 weeks after starting of treatment, up to 44 weeks.|Patients from Treated Set (TS).||percentage change in tumour size||Standard Error|Mean
90362|NCT00906698|Secondary|Duration of Disease Control|Duration of disease control was measured from the start of study treatment to the time of progression or death, whichever occured first.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with disease control.||days||Full Range|Median
90363|NCT00906698|Secondary|Duration of Objective Response|The duration of objective response was measured from the time of first documented confirmed CR or PR to the time of progressive disease or death, whichever occured earlier.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with Objective Response.||days||Full Range|Median
90364|NCT00906698|Secondary|Time to Objective Response|The time to OR was the duration from the first treatment to the time when the measurement criteria for first documented confirmed CR and/or PR were met according to RECIST 1.0 criteria.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from the Treated Set (TS) with objective response.||days||Full Range|Median
90365|NCT00906698|Secondary|Number of Patients With Disease Control (DC)|DC is defined as confirmed complete response (CR), partial response (PR) and stable disease (SD) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).||participants|||Number
90366|NCT00906698|Secondary|Number of Patients With Objective Response (OR)|OR is defined as confirmed complete response and confirmed partial response (PR) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).||participants|||Number
92848|NCT00878722|Secondary|Elimination t½||Cycle 1, Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d||Hours||Standard Deviation|Mean
90367|NCT00906698|Secondary|Number of Patients With Best Overall Response|Overall response is defined as complete response, partial response and stable disease and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). Complete response (CR) and partial response (PR) had to be confirmed by a subsequent tumour assessment at least 28 days after the criteria for CR or PR were first met. To confirm a status of stable disease, the duration of stable disease was to be at least 42 days.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).||participants|||Number
90368|NCT00906698|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). 3+3 dose escalation design. MTD based on DLTs during first treatment course. After MTD was determined, additional patients were included at the MTD in an expansion cohort.|28 days|Treated Set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||participants|||Number
90369|NCT00906503|Primary|Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging|The blood glucose of all patients will be checked by accu-check before the injection of 18F-FDG. The acceptable blood glucose level will be ≤120 mg/dl. Any participant experienced elevated fasting blood glucose of more than 120 mg/dl after steroid therapy, he /she will be asked to come back to the PET center within 48 hours to check the blood glucose level. If the blood glucose level did not decline to baseline level, the participant will be asked to follow with his/her family doctor for management. Participants with history of systemic hypertension will be monitored for increased blood pressure. After 50-to-70 minutes period for FDG incorporation into presumed lesions, patient will under go a limited 18F-FDG PET/CT for the area of the interest (1-2 bed positions). PET imaging will be performed using a GE Discovery STE PET/CT system (GE Medical Systems, Milwaukee, WI).|24-48 hours|||gm/ml||Standard Deviation|Mean
90370|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|12 months|||% of implants|||Number
90371|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|6 months|||% of implants|||Number
90372|NCT00906425|Primary|Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)|The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.|Baseline and 6 months|ITT population||millimeters||Standard Deviation|Mean
90373|NCT00906399|Secondary|Estimated Proportion of Participants With Sustained Disability Progression at 1 Year|Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.|1 Year|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression.||proportion of participants|||Number
90374|NCT00906399|Secondary|Proportion of Participants Relapsed at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.|Year 1|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrew from study were censored at the time of switch/withdrawal.||proportion of participants|||Number
90375|NCT00906399|Secondary|Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year|Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.|1 Year|ITT population, with at least 1 post-baseline assessment. Missing data prior to alternative MS medications and visits after participants switched to alternative MS medications imputed based on previous visit data assuming the constant rate of lesion development or group mean at same visit.||lesions||95% Confidence Interval|Mean
90376|NCT00906399|Primary|Annualized Relapse Rate (ARR) at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).|1 Year|Intent-to-treat (ITT) population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).||relapses per person-years||95% Confidence Interval|Number
90377|NCT00906347|Secondary|Time Elapsed From Start of Labor Augmentation to Delivery||Initiation of augmentation until delivery|Intent to treat||minutes||Inter-Quartile Range|Median
90378|NCT00906347|Secondary|Method of Delivery||At delivery|Intent to treat||participants|||Number
90379|NCT00906347|Secondary|Maternal Hypovolemia Requiring Blood Transfusion||Until hospital discharge|Intent to treat||participants|||Number
90380|NCT00906347|Secondary|Maternal Chorioamnionitis|Temperature 38 degrees C or higher in the absence of other sources of infection|During labor|Intent to treat||participants|||Number
90381|NCT00906347|Secondary|Admission of Neonatal Intensive Care Unit||Until hospital discharge|Intent to treat||infants|||Number
90382|NCT00906347|Secondary|Umbilical Cord Artery pH <7.1||Obtained at delivery|Intent to treat||infants|||Number
90383|NCT00906347|Secondary|Infant Apgar Score <4|Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.|5 minutes after delivery|Intent to treat||infants|||Number
90384|NCT00906347|Primary|Uterine Tachysystole|Defined as six contractions in two consecutive 10-minute periods|Up to four hours after administration of study drug|Intent to treat||participants|||Number
90385|NCT00906243|Primary|Phase I: Assessment of Safety and Tolerability of the Trial Regimen|"Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0:~All Categories equal or greater than grade 3~Allergy/autoimmunity equal or greater than grade 2~Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0."|At Nine Weeks with Follow Up at One Year|Phase 1 consisted of cohort 1 with 3 subjects and cohort 2 with three subjects.||events|||Number
90386|NCT00906204|Secondary|Kidney Function|Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study)|12 months post-transplantation|||mL/min/1.73m^2||Standard Deviation|Mean
90387|NCT00906204|Secondary|Incomplete Thymoglobulin Infusion||First 7 days post-transplantation|||participants|||Number
90388|NCT00906204|Secondary|Acute Kidney Rejection|Kaplan-Meier probability estimates of rejection rates|12 months post-transplantation|||participants|||Number
90389|NCT00906204|Secondary|Graft Survival|Kaplan-Meier estimates of graft survival probability for 12 months after transplantation|12 months post-transplantation|||participants|||Number
90390|NCT00906204|Secondary|Patient Survival|Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation.|12 months post-transplantation|||participants|||Number
90391|NCT00906204|Primary|Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function|"The composite endpoint components and definitions are:~Fever: Body temperature ≥ 38.5˚C.~Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors.~Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for > 12 hours out of a 24 hour period.~Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia)~Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation"|During first 7 days after kidney transplantation|||participants|||Number
90392|NCT00906178|Secondary|Unprotected Sex at Three-month Follow-up|Ever had vaginal or anal sex without a condom in the past 90 days|3 months post-intervention|ITT--Intention to Treat||participants|||Number
90393|NCT00906178|Secondary|Abstinence at Three-month Follow-up|Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days|3 months post-intervention|ITT--Intention to Treat||participants|||Number
90394|NCT00906178|Primary|Sexual Abstinence|Not having had vaginal or anal sex in the past three months|6-months post-intervention|ITT - Intention to Treat||participants|||Number
90395|NCT00906178|Primary|Sex Without a Condom as Assessed by Self-report|Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months|6-months post-intervention|ITT - Intention to Treat||participants|||Number
90396|NCT00906074|Secondary|Number of Participants With Antimicrobial Resistance|Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Number of participants|||Number
90397|NCT00906074|Secondary|Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)|Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Percentage of participants|||Number
90398|NCT00906074|Secondary|Classification of SSI Infection|Participants with organ-space or deep incisional SSI.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||participants|||Number
90399|NCT00906074|Secondary|ASEPSIS Classification in Participants With Serious SSI|Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay in hospital prolonged over 14 days (ASEPSIS). ASEPSIS classification is a numerical indication of wound healing progress: satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (20-30), moderate wound infection (30-40), and severe wound infection (over 40).|Up to 30 days post surgery|Subset of study population with infection||participants|||Number
90400|NCT00906074|Secondary|Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0|Percentage of participants with NNISS score for increased preoperative risk of infection.|Baseline (pre-surgical)|Study population||Percentage of participants|||Number
90401|NCT00906074|Primary|Percentage of Participants With Post-surgical Drainage||Day 0 (day of surgery) up to 30 days post surgery|Study Population||Percentage of participants|||Number
90402|NCT00906074|Primary|Percentage of Participants Who Showed Clinical Improvement of SSI|Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Percentage of participants|||Number
90403|NCT00906074|Primary|Percentage of Participants With Infection|Microorganism infection by bacterial type.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data||Percentage of participants|||Number
90404|NCT00906074|Primary|Type of Surgeon|Surgical speciality of physician who performed surgery.|Day 0 (day of surgery)|No data collected||surgeon|||Number
90427|NCT00905632|Secondary|Number of Participants With Sustained Virological Response|Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (<10 IU/mL) at least 85 days after stopping standard care (SOC).|Until end of treatment, up to 570 days|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
90405|NCT00906074|Primary|Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty|Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin. Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds. Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.|Day 0 (day of surgery)|Study population||Percentage of participants|||Number
90406|NCT00906074|Primary|Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery||Day 0 (day of surgery)|Study Population||Percentage of participants|||Number
90407|NCT00906074|Primary|Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis||Baseline (Pre-surgical)|Study Population||Percentage of participants|||Number
90408|NCT00906074|Primary|Percentage of Participants With Pre-surgical Morbidities|Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared [BMI kg/m2]) greater than (>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin [Hb] less than (>) 9 grams per deciliter [gr/dL]) or malnutrition (hypoalbuminemia).|Baseline (Pre-surgical)|Study population: participants with or without SSI after surgery, treated in major hospitals with general surgical units located in Spain||percentage of participants|||Number
90409|NCT00905840|Secondary|Soft Tissue and Safety Assessments|"Modified Plaque Index (mPI) and modified Sulcus Bleeding Index (mSBI) according to Mombelli at al. (1987). Assessment to be perform at four sites per implant: lingual, buccal, mesial, and distal.~mPI: 0=no plaque detected, 1=plaque only recognized by running a probe across the smooth marginal surface of the implant, 2=plaque can be seen by the naked eye, 3=abundance of soft matter.~mSBI: 0=no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant, 1=isolated bleeding spot visible, 2=blood forms a confluent red line on margin, 3=heavy or profuse bleeding.~Safety evaluations including recording of all complications, adverse events (AEs), and serious adverse events SAEs). Each AE and SAE will be assessed for severity and its potential relationship to the study device."|after 12, 24, and 36 month|"The numbers represent subjects that are classified as Yes. mPI: if all 4 evaluated scores are 0 or 1, the mPI will be classified as No. If at least one score is 2 or 3, mPI will be classified as Yes.~mSBI: if all evaluated scores are 0 or 1, mSBI will be classified as No. If at least one score is 2 or 3, mSBI will be classified as Yes."||participants|||Number
90410|NCT00905840|Secondary|Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990|"split-mouth design~Implant success and survival rate according the definition by Buser et al. 1990 are:~Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysaesthesia~Absence of a recurrent peri-implant infection with suppuration~Absence of mobility~Absence of a continuous radiolucency around the implant~Possibility for restoration"|at 12, 24 and 36 months post surgery|The analysis was determined as Intent To Treat (ITT). The study population consisted of each randomized patient who received the device.||implants|Participants||Number
90411|NCT00905840|Primary|Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.|"Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material.~The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used."|12 months|The Intent To Treat (ITT) populaton consisted of all randomized patients who received implants and who underwent at least one efficacy assessment.||mm|Participants|Full Range|Mean
90412|NCT00905827|Secondary|Satisfaction With Training|Evaluation included 20 standard items assessing providers satisfaction with training, including items similar to other published satisfaction surveys. Survey items were rated using a five-point Likert scale indicating the degree to which respondents agreed or disagreed. Questions were always phrased positively so that agree or strongly agree is equivalent to a positive response.|post-training|||participants|||Number
90413|NCT00905827|Primary|Provider Self-efficacy and Beliefs About Suicidality|Assessed beliefs and confidence in managing suicidal individuals. Using a 5-point Likert scale, there were 11 items that addressed the following: competence, reactions, beliefs, motivations, and CAMS as it relates to their practice. Scores ranged from 11-55 with questions were phrased so higher scores indicated more positive views.|post-training|||units on a scale||Standard Error|Mean
90414|NCT00905632|Secondary|Number of Participants With Discontinuations Due to AEs|Number of participants with adverse events (AEs) leading to discontinuation of trial drug|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||participants|||Number
90415|NCT00905632|Secondary|Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG|Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.|From the start of the study to Day 30 (2 days after last dose)|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||participants|||Number
90428|NCT00905632|Secondary|Number of Participants With End of Treatment Response|Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders* - Response = Viral load below the limit of detection at end of all treatment.|Week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
90416|NCT00905632|Secondary|RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ratio||Geometric Coefficient of Variation|Geometric Mean
90417|NCT00905632|Secondary|t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||hour||Geometric Coefficient of Variation|Geometric Mean
90418|NCT00905632|Secondary|λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||1/h||Geometric Coefficient of Variation|Geometric Mean
90419|NCT00905632|Secondary|AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
90420|NCT00905632|Secondary|C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).|654 hours after drug administration on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90421|NCT00905632|Secondary|Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168|Cpre,N [ng/mL] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.|5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90422|NCT00905632|Secondary|AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168|30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
90423|NCT00905632|Secondary|Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|tmax [h] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||hour||Geometric Coefficient of Variation|Geometric Mean
90424|NCT00905632|Secondary|Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90425|NCT00905632|Secondary|Plasma Concentration Time Profiles of CD 6168|Plasma concentration time profiles of CD 6168|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90426|NCT00905632|Secondary|Plasma Concentration Time Profiles of BI 207127|Plasma concentration time profiles of BI 207127|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90429|NCT00905632|Secondary|Number of Participants With Early Virological Response|Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)|Baseline and week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
90430|NCT00905632|Secondary|Number of Participants With Rapid Virological Response|Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
90431|NCT00905632|Secondary|Number of Participants With Virologic Response at Day 28|Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), <10 IU/mL, at day 28|day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.||Participants|||Number
90432|NCT00905632|Secondary|Viral Load at Each Visit up to Day 28|Viral load (VL) (original values) at each visit up to day 28.|Baseline and days 8, 15, 22 and 28|Pharmacodynamic (PD) set which included patients in the treated set but excluded VL values after recorded treatment stop time and values after subjects took wrong or additional doses of treatment. Also one patient was excluded from all descriptive PD summaries due to a protocol violation and another excluded as they did not have a predose VL value.||IU/mL||Full Range|Median
90433|NCT00905632|Secondary|Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline|"Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.~A negative value represents an increase in viral load, a positive value represents a decrease in viral load."|Baseline and days 1, 2, 4, 8, 15, 22 and 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available viral load data at baseline and day 28.||IU/mL||Full Range|Median
90434|NCT00905632|Primary|Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.|The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir.|Baseline and 4 weeks|Full Analysis Set (FAS): The subset of patients in the treated set (TS) that had at least one measurement of efficacy.||Participants|||Number
90435|NCT00905606|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90436|NCT00905606|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90437|NCT00905606|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90438|NCT00905580|Primary|Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively||1, 6, 24 & 48 hours|||participants|||Number
90439|NCT00905580|Secondary|Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.|we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.|3 months|||participants|||Number
90440|NCT00905580|Primary|The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. We asked patients about sedation, headache, dizziness, blurred vision.|1, 6, 24 & 48 hours|||participants|||Number
90441|NCT00905580|Primary|Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 means no pain at all, and 10 represents the worst pain imaginable|1, 6, 24 & 48 hours|||VNRS||Inter-Quartile Range|Median
90442|NCT00905567|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was used in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90443|NCT00905567|Primary|AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90444|NCT00905567|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in statistical analysis.||ng/mL||Standard Deviation|Mean
90445|NCT00905554|Secondary|Evaluation of Pain and Tolerability Scores|Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)|6-9 months|||Scores on a VAS scale||Inter-Quartile Range|Median
90446|NCT00905554|Primary|Number of Patients Undergoing Complete Unsedated Colonoscopy||6-9 months|||participants|||Number
90447|NCT00905515|Primary|Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine and Transforming Growth Factor Beta (TGF-B)||6 months, 1 year, 2 years, 3 years||||||
90448|NCT00905515|Primary|Optimal Dose/Blood Level of Prograf in Long-term Maintenance Kidney Transplant Patients||6 months, 1 year, 2 years, 3 years||||||
90449|NCT00905515|Primary|Renal Function in Patients Converted From Cyclosporine to Prograf||6 months, 1 year, 2 years and 3 years|||Change in serum creatinine (mg/dL)||Full Range|Mean
90450|NCT00905489|Other Pre-specified|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Last Available Visit|Patients maintaining a viral load < 50 copies/mL at the last available visit|Last available visit, up to 155 weeks|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase with VL data available||percentage of patients|||Number
90451|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL in Optional Extension Phase|Patients maintaining a viral load < 400 copies/mL at week 24 of the Optional Extension Phase (OEP)|week 24|Full analysis set including patients with available viral load data at week 24||percentage of patients|||Number
90452|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Week 24 of Optional Extension Phase|Patients maintaining a viral load < 50 copies/mL at week 24 (approximately 168 days) of Optional Extension Phase (OEP).|week 24|Full analysis set including patients with available viral load data at week 24||percentage of patients|||Number
90453|NCT00905489|Secondary|Percentage Change From Baseline in Mean CD4+ Count|((Day 22 value-Baseline value)/Baseline value)*100. ((Week 24 value-Baseline value)/Baseline value)*100.|Baseline to day 22 and baseline to week 24|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase, and had available data at either day 22 or week 24.||percentage change||Standard Deviation|Mean
90454|NCT00905489|Secondary|Change From Baseline in Mean CD4+ Count (Absolute)|Change in mean CD4+ count (absolute) from baseline to Day 22 and from baseline to Week 24.|Baseline, Day 22 and week 24|PK Analysis set: This patient set includes all patients in the Full Analysis Set (FAS) that have no protocol violations excluding them from PK analysis.||cells/mm^3||Standard Deviation|Mean
90455|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL|Patients maintaining a viral load < 400 copies/mL at Day 22|Day 22|Full analysis set including patients with available viral load data at day 22||percentage of patients|||Number
90456|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL|Patients maintaining a viral load < 50 copies/mL at Day 22.|Day 22|Full analysis set including patients with available viral load data at day 22||percentage of patients|||Number
90457|NCT00905489|Secondary|Cavg|Average measured concentration of the Nevirapine in plasma at steady state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90458|NCT00905489|Secondary|CL/F,ss|Apparent clearance of the Nevirapine in the plasma after extravascular administration at steady-state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||mL/h||Geometric Coefficient of Variation|Geometric Mean
90459|NCT00905489|Secondary|Tmax,ss|"Time from dosing to the maximum concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.~The standard deviation is actually the coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||hours||Standard Deviation|Mean
90460|NCT00905489|Secondary|%PTF|Percentage peak-trough Nevirapine fluctuation, % fluctuation (degree of peak to trough fluctuation) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
90461|NCT00905489|Secondary|Ratio Cmax,ss/Cmin,ss|Ratio of (maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ)/(minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||Ratio||Geometric Coefficient of Variation|Geometric Mean
90462|NCT00905489|Secondary|Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90463|NCT00905489|Secondary|Cmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Minimum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ by nevirapine XR dose group Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 21.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
90464|NCT00905489|Secondary|AUCt,ss|"Area under the concentration-time curve of the Nevirapine (NVP) in plasma at steady state over the time dosing interval τ.~All patients received nevirapine IR for 10 days prior to collection of 12-hour Area Under the Curve (AUC) data. Then, all patients were switched to nevirapine XR for 9 days prior to collection of 24-hour AUC data. The treatments of IR and XR are summarized separately using geometric means and geometric coefficients of variation.~For NVP IR AUC measured over hours: 0,1,2,3,4,8 and 12, For NVP XR AUC measured over hours: 0,1,2,3,4,8,10,12 and 24."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.||ng*h/ml||Geometric Coefficient of Variation|Geometric Mean
90465|NCT00905489|Primary|Trough Cpre,N.|"Trough Nevirapine concentration immediately prior to the next scheduled dose. Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.~The measure of dispersion presented is the coefficient of variation (%) rather than the geometric coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|PK analysis set (PKS): This patient set includes all patients in the Full Analysis Set (FAS) set that have no protocol violations excluding them from PK analyses.||(ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
90466|NCT00905437|Secondary|Number of Participants With Neuropathic Pain|"ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. Yes response to questions 1-5 were scored as 1, while a yes response to question 6 was scored as -1. No response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported."|Day 90, Day 180 post-surgery|Data was not analyzed as the intended sample size was not met, and the reported numbers from the final set were not sufficient for a meaningful analysis.|||||
90467|NCT00905437|Secondary|Number of Participants With Rescue Medication Usage|Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications.|Day 0 to Day 6 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications.||participants|||Number
90468|NCT00905437|Secondary|Time to Mobilization After Surgery|Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Inter-Quartile Range|Median
90469|NCT00905437|Secondary|Mean Anxiety Visual Analogue Scale (A-VAS)|Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious.|Day 0 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||Units on a scale||Standard Error|Mean
90470|NCT00905437|Secondary|Mean Daily Sleep Interference Score|Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||Units on a scale||Standard Error|Mean
90471|NCT00905437|Secondary|Mean Daily Pain Score|Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Day 1 to Day 7, Day 8 to Day 14 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm.||Units on a scale||Standard Error|Mean
90472|NCT00905437|Primary|Mean Pain on Movement Score|Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.|Every 12 hours from Day 1 to Day 5 post-surgery|Modified Intent to Treat (MITT) population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||Units on a scale||Standard Error|Mean
90473|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
90559|NCT00904943|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90474|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
90475|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6|BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Augmentation baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
90476|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|FAS||Percent of participants|||Number
90477|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation Baseline|FAS||Percent of participants|||Number
90478|NCT00905424|Secondary|Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Percent of participants|||Number
90479|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
90480|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline and 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
90481|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.||Units on a scale||Standard Error|Least Squares Mean
90482|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
90483|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
90484|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6|BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
90485|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|Primary Efficacy Analysis Set||Percent of participants|||Number
90486|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation baseline|Primary Efficacy Analysis Set||Percent of participants|||Number
90487|NCT00905424|Secondary|Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|Primary Efficacy Analysis Set||Percent of Participants|||Number
90488|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
90585|NCT00904826|Secondary|Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point|Visual acuity was measured using the the Visual Acuity subscale of the Opticospinal Impairment Score (OSIS) for Exacerbations. This subscale ranges from 0 (normal) to 8 (no light perception).|12 months|||participants|||Number
90489|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set||Units on a scale||Standard Error|Least Squares Mean
90490|NCT00905424|Primary|Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.||Units on a scale||Standard Error|Least Squares Mean
90491|NCT00905359|Secondary|Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months||14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||participants|||Number
90492|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
90493|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
90494|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
90495|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.||correlation coefficient|||Number
90496|NCT00905359|Secondary|Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points|Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||participants|||Number
90497|NCT00905359|Secondary|Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points|The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||mm^2||Standard Deviation|Mean
90498|NCT00905359|Secondary|Percentage of Subjects With Serious Adverse Device Effects||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).||percentage of subjects|||Number
90499|NCT00905359|Secondary|Number of Subjects Requiring Secondary Surgical Intervention||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).||participants|||Number
90500|NCT00905359|Secondary|Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire|The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage of change from baseline||Standard Deviation|Mean
90501|NCT00905359|Secondary|Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain|Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage of change from baseline||Standard Deviation|Mean
90502|NCT00905359|Secondary|Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||units on a scale||Standard Deviation|Mean
90503|NCT00905359|Secondary|Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.|14days, 6 week, 6 months, 12 months, 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage change from baseline||Standard Deviation|Mean
90504|NCT00905359|Secondary|Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.|14 days, 6 weeks, 6 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage change from baseline||Standard Deviation|Mean
90505|NCT00905359|Primary|Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.|1 year|Per-protocol analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).||percentage change from baseline||Standard Deviation|Mean
90506|NCT00905346|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90507|NCT00905346|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90508|NCT00905346|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90509|NCT00905307|Secondary|Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712|Efficacy-related discontinuation rate was assessed|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Percentage of participants|||Number
90510|NCT00905307|Secondary|Response Rate at Week 6|Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score; or a CGI–I score of 1 (very much improved) or 2 (much improved) at Week 6|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impuite missing data.||Percentage of participants|||Number
90511|NCT00905307|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) at Week 6|The rater or investigator rated the particpant’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant’s condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
90512|NCT00905307|Secondary|Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)|The severity of illness for each participant was rated using the CGI–S. To perform this assessment, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
90513|NCT00905307|Secondary|Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains. The rating is based on four main areas: (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. The ratings are converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Ratings from 71-100 reflect only mild difficulties. Ratings from 31-70 reflect manifest disabilities of various degrees. Ratings from 1-30 reflect functioning so poor that intensive support or supervision is needed.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
90514|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. PANSS negative subscale score is the sum of the rating scores for the 7 negative scale items from the PANSS panel. The PANSS negative subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
90586|NCT00904826|Secondary|Change in Expanded Disability Status Scale (EDDS) Score|The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.|baseline, 12 months|||units on a scale||95% Confidence Interval|Mean
90515|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS positive subscale score is the sum of the rating scores for the 7 positive scale items from the PANSS panel. The PANSS positive subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
90516|NCT00905307|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The last observation carried forward (LOCF) method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
90517|NCT00905268|Secondary|Change in Peak Workload From Baseline to Week 52|"Assessed by a modified exercise test, in a subset of patients able to undertake this.~Wpeak has been calculated from the following formula: Workload last fully completed stage + (seconds completed in last stage / 60 * (4 [if arm ergonometry] or 10 [if leg ergonometry]))."|1 year|||Watts||Standard Deviation|Mean
90518|NCT00905268|Secondary|Change in Peak Systolic Strain Rate From Baseline to Week 52|Mean Change of Peak systolic longitudinal strain rate (PSLSR) from Baseline to Week 52 in subjects with cardiac involvement (FRDA-CM criteria), where positive value in PSLSR is a deterioration and negative value an improvement.|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)||1/s||Standard Deviation|Mean
90519|NCT00905268|Secondary|Proportion of Patients Improving on Left Ventricular Peak Systolic Strain Rate or Showing a Reduction in Left Ventricular Mass Index (LVMI) With no Worsening in Strain Rate|(In the statistical analysis sub-population presenting with cardiac involvement as defined by the FRDA cardiomyopathy criteria)|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)||percentage of patients|||Number
90520|NCT00905268|Secondary|Proportion of Patients Improving (Responding) on ICARS by a Clinically Relevant Margin|"The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.~ICARS Responder Analysis at Week 52: Percentage of subjects Improving by 2.5 Points or More."|week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.||percentage of patients|||Number
90521|NCT00905268|Secondary|Absolute Change in Friedreich's Ataxia Rating Scale (FARS) Scores From Baseline Assessment to Week 52|The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, and activities of daily living subscale and a neurological subscale. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|Baseline and week 52|The comparison was carried out in the ITT population, on data imputed using the last observation carried forward (LOCF) method.||units on a scale||Standard Deviation|Mean
90522|NCT00905268|Primary|Absolute Change in International Cooperative Ataxia Rating Scale (ICARS) Scores From Baseline Assessment to Week 52|The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline and week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.||units on a scale||Standard Deviation|Mean
90523|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||participants|||Number
90569|NCT00904839|Secondary|Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I)|Area under the plasma concentration time-curve over 12 hours for Nintedanib in the dosing interval at steady state and normalized by the dosing unit administered (AUCtau,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h and 10h after drug administration.|Treated Set (TS).||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
90524|NCT00905255|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period and “n” = patients with FPG assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||mmol/L||Standard Deviation|Mean
90525|NCT00905255|Secondary|Change From Baseline in Body Weight for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline weight assessment during on-treatment period and “n” = patients with weight assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||kilogram||Standard Deviation|Mean
90526|NCT00905255|Primary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with treatment emergent adverse events (TEAEs) during the 24-week treatment period: any TEAE; any serious TEAE; any TEAE leading to death; and any TEAE leading to permanent treatment discontinuation.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||percentage of participants|||Number
90527|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
90528|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
90529|NCT00905255|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76|Absolute change = HbA1c value at week of assessment (Week 52/Week 76) minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of hemoglobin||Standard Deviation|Mean
90530|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
90531|NCT00905255|Other Pre-specified|Percentage of Patients Requiring Rescue Therapy|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 4 to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%, from Week 24 to end of treatment (Week 76): fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 52, Baseline up to Week 76|mITT population.Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
90532|NCT00905255|Secondary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with TEAEs during the on-treatment period: any TEAE; any serious TEAE; any TEAE leading to death; any TEAE leading to permanent treatment discontinuation. The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose at Week 76.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified||percentage of participants|||Number
90533|NCT00905164|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90534|NCT00905164|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90535|NCT00905164|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng/mL||Standard Deviation|Mean
90536|NCT00905151|Primary|Performance of Glomerular Filtration Rate (GFR) Estimating Equations|Overall bias, median difference (95% confidence interval), mL/min per 1.73 m^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.|Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.|||mL/min per 1.73 m^2||95% Confidence Interval|Median
90537|NCT00905125|Primary|Number of Participants With a Four-fold or Greater Rise in HAI Antibody Titer Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a four-fold increase in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.||Participants|||Number
90538|NCT00905125|Secondary|Microneutralization Assay Geometric Mean Antibody Titers Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.||Participants|||Number
90539|NCT00905125|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.||Titer||95% Confidence Interval|Mean
90540|NCT00905125|Primary|Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature|Participants recorded a daily oral temperature on a memory aid for 8 days (Days 0-7) after vaccination. The protocol defined mild fever as oral temperatures 37.8 to less than 38 degree Celsius, moderate fever as 38 to less than 39 degrees Celsius and severe fever as oral temperatures of 39 degrees Celsius or higher. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
90541|NCT00905125|Primary|Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which systemic symptoms of feverishness, malaise, myalgia, headache and nausea were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
90542|NCT00905125|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade|Participants recorded a daily measured value of swelling and redness, if present. The protocol defined grading of small, medium and large, with small as less than 20 mm, medium as 20-50 mm and large as greater than 50 mm. Participants are counted at the largest measured grade experienced across the 8 day period after vaccination.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
90543|NCT00905125|Secondary|Number of Participants With a Four-fold or Greater Rise in Microneutralization Antibody Titer Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. The threshold of a four-fold increase in titer would be met if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.||Participants|||Number
90544|NCT00905125|Secondary|Number of Participants With a Serum Microneutralization Antibody Titer of Greater Than or Equal to 40 Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.||Participants|||Number
90545|NCT00905125|Primary|Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which local reactions of pain, tenderness and swelling were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
90546|NCT00905125|Primary|Number of Participants Reporting Unsolicited Non-serious Adverse Events Considered Associated With Vaccination|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
90547|NCT00905125|Primary|Number of Participants Reporting Serious Adverse Events (SAE)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes. All events are included regardless of association to vaccination.|Through 6 months post vaccination.|All participants are included in the ITT safety population for this outcome measure.||Participants|||Number
90548|NCT00905125|Primary|Number of Participants Reporting Neonatal Complications.|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All live births are included in this outcome measure, which excludes three participants whose pregnancies ended in miscarriage or stillbirth (reported as maternal complications). Three participants gave birth to twins, who are each counted separately.||Participants|||Number
90549|NCT00905125|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.||Participants|||Number
90550|NCT00905125|Primary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV)|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.||Participants|||Number
90551|NCT00905034|Primary|Complete Response (CR) Rate|Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.|6 cycles (cycle = 28 days)|Of the 37 participants enrolled, 36 participants completed therapy and were evaluable for response.||percentage of participants|||Number
90552|NCT00905021|Secondary|Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells||5 years||||||
90553|NCT00905021|Secondary|Determine the Safety and Tolerability||5 years||||||
90554|NCT00905021|Secondary|Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival||5 years|The study was terminated early before target accrual.|||||
90555|NCT00905021|Primary|Time to Disease Progression in Weeks|Time from the first day of treatment to date of progression in weeks|Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance|2 patients developed disease progression.||week||Full Range|Mean
90556|NCT00904995|Primary|Percentage of Samples With BG Levels > 60pg/ml|"Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI).~Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity."|Up to 42 days|Analysis was intent to treat with a total of 182 samples (mean 8.6 samples/participant) drawn from participants.||percent of blood samples|Participants||Number
90557|NCT00904943|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90558|NCT00904943|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.||ng*hr/mL||Standard Deviation|Mean
90560|NCT00904917|Secondary|Child's Report on Parental Behavior Inventory (CRPBI)|Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents’ perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the CRPBI, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).||units on a scale||Standard Deviation|Mean
90561|NCT00904917|Secondary|Understanding Mood Disorders Questionnaire (UMDQ)|Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the UMDQ, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).||units on a scale||Standard Deviation|Mean
90562|NCT00904917|Primary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the MASC which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).||T scores||Standard Deviation|Mean
90563|NCT00904917|Primary|Children Depression Inventory (CDI)|Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.|Measured at baseline and at post-treatment (8 weeks after baseline)|These scores are based on the CDI which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).||T scores||Standard Deviation|Mean
90564|NCT00904839|Secondary|Exploratory Biomarker and Pharmacogenetic Analysis for VEGF|"Exploratory biomarker and pharmacogenetic analysis for Vascular endothelial growth factor (VEGF).~Note: This endpoint was not statistically analysed in this study."|Day 1, Day 29, Day 57, Day 85 and Day 127||||||
90565|NCT00904839|Secondary|Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag.|Number of participants for Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the first use of stoma bag.|from baseline until end of treatment, up to 892 days|Treated Set (TS).||participants|||Number
90566|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the change from baseline at 9 months for functional scales, Symptom scales Chemotherapy side effects .~The EORTC-QLQ-CR38 was composed of functioning scales (body image, future perspective, sexual enjoyment, sexual functioning) and symptom scales (chemotherapy side effects, defecation problems, symptoms of the gastrointestinal tract, micturition problems,female sexual problems, male sexual problems, stoma related problems, and weight loss).~Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for functional scales and a worse quality of life for symptom scales."|Baseline and 9 months.|Treated Set (TS)||units on scale||Standard Deviation|Mean
90567|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 for the change from baseline at 9 months for Global health status scores.~Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for Global health status scores"|Baseline and 9 months.|Treated Set (TS). Number of analysed patients are the total number of patients who were analysed for the change from baseline at 9 months for Global health status scores||units on scale||Standard Deviation|Mean
90568|NCT00904839|Secondary|Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I)|Maximum plasma concentration for Nintedanib at steady state and normalized by the dosing unit administered (Cmax,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h, and 10h after drug administration.|Treated Set (TS).||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
90570|NCT00904839|Secondary|Maximum Tolerable Dose (MTD)|Determination of Maximum Tolerable Dose based on DLT incidence.|First two treatment cycles, up to 28 days|MTD Set||mg|||Number
90571|NCT00904839|Secondary|Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I).|Percentage of patients with DLTs,AE were observed in Gastrointestinal,Hepatobiliary & skin and subcutaneous tissue disorder.Drug related DLT was defined:1)Gastrointestinal toxicity(vomiting, nausea and diarrhoea)or hypertension of CTCAEgrade(G)3 despite optimal supportive care/intervention.2)Non-haematological toxicity of G≥3 except AE:alopecia,nail modifications,& isolated elevation of gamma glutamyl transpeptidase.3)G4 neutropenia for>7days(not associated with fever≥38.5°C).4)Neutropenia of G≥3 of any duration associated with fever≥38.5ºC.5)Platelets <25,000/μLorG3 thrombocytopenia associated with bleeding requiring transfusion.6)Inability to resume nintedanib dosing within14days of stopping due to treatment related toxicity.7)ALT and/or AST elevation of G≥3orG≥2 in conjunction with bilirubin G>1. 8)Inability to recover from increase ALT/AST in conjunction with increase of bilirubin toALT/AST toG≤1 &bilirubin to normal or baseline within14days after nintedanib treatment interruption|First two treatment cycles, up to 28 days|MTD set: The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study. The outputs (updated with cleaned and more complete data) that were used to decide on the MTD of nintedanib while the study was ongoing.||percentage of participants|||Number
90572|NCT00904839|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days|Treated Set (TS)||participants|||Number
90573|NCT00904839|Secondary|Tumor Shrinkage|"For each patient, the minimum percentage increase from baseline measurement (≤ 28 days before the beginning of the treatment) of the sum Longest diameter (LD) of target lesions was calculated based on the measurements of tumor size. The minimum percentage increase has been divided to four groups:~<= - 30%~> - 30% and < 0%~>= 0% and < 20%~>=20%"|Baseline and day 85|Treated Set (TS)||participants|||Number
90574|NCT00904839|Secondary|Resection Rate|"Surgical excision of the lesions is allowed if the previous assessment of tumoral response occurred after at least 6 cycles of treatment. Resection Rate includes resection rates R0, R1 and R2 before progressive disease.~Peto's variance estimate was used."|First treatment administration until end of treatment, up to 892 days|Treated Set (TS)||percentage of Participants||95% Confidence Interval|Number
90575|NCT00904839|Secondary|Unconfirmed Objective Response Rate|Objective response is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% Confidence interval represent the Clopper- Pearson exact confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||percentage of Participants||95% Confidence Interval|Number
90576|NCT00904839|Secondary|Confirmed Objective Response Rate|Objective response rate is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% confidence interval represent the Clopper-Pearson exact confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||percentage of Participants||95% Confidence Interval|Number
90577|NCT00904839|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death throughout the whole study. Progression is assessed according to RECIST criteria (version 1.0). In this endpoint, the Greenwood's variance estimate was used to calculate the Kaplan-Meier progression free survival median and its corresponding 95% confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||months||95% Confidence Interval|Median
90578|NCT00904839|Secondary|Overall Survival|Overall survival is defined as the time from first treatment until death. Greenwood variance was used for the calculation of 95% confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).||months||95% Confidence Interval|Median
90579|NCT00904839|Primary|Progression-free Survival Rate at 9 Months (PFS-9)|"PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0).~20% increase in the sum of the longest diameter of target lesions.~The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|First treatment administration to nine months|Treated Set (TS) - The treated set includes all patients who were dispensed and were documented to have taken at least one dose of the trial drug.||percentage of Participants||95% Confidence Interval|Number
90580|NCT00904826|Secondary|Mean Complement Protein 5 (C5) Concentration in CSF||baseline, 3 months|At 3 months, C5 was undetectable in 6 subjects; patient 13 was excluded because she had temporarily discontinued treatment.||ng/mL||Standard Deviation|Mean
90581|NCT00904826|Secondary|Mean Eculizumab Concentration in Cerebrospinal Fluid (CSF)||3 months|12 subjects including subject 13 agreed to have CSF draw at the 3 month visit, but subject 13 was excluded because she had temporarily discontinued treatment.||ng/mL||Standard Deviation|Mean
90582|NCT00904826|Secondary|Percentage Hemolysis|Percentage of hemolysis is a measure of complement activity. Less than 20% lysis is deemed to be complete complement inhibition.|baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months|Subject 13 was excluded at 3 months visit because she had temporarily discontinued treatment.||percentage of hemolysis||Standard Deviation|Mean
90583|NCT00904826|Secondary|Mean Serum Concentration of Eculizumab||6 weeks, 3 months, 6 months, 9 months, 12 months|Patient 13 was excluded from the 3 months measurement because she had temporarily discontinued treatment.||micrograms/mL||Standard Deviation|Mean
90584|NCT00904826|Secondary|Number of Subjects With Change in Ambulation by at Least 1 Point|Ambulation was measured by the Hauser Ambulation Index, which ranges from 0 (asymptomatic; fully active) to 9 (restricted to wheelchair; unable to transfer self independently.)|12 months|||participants|||Number
90587|NCT00904826|Secondary|Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment||12 months|||participants|||Number
90589|NCT00904748|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.||participants|||Number
90590|NCT00904748|Secondary|Half-life (T 1/2)|Terminal elimination half-life.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||hours||Standard Deviation|Mean
90591|NCT00904748|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time at which maximum plasma concentration (Cmax) occurred.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||hours||Standard Deviation|Mean
90592|NCT00904748|Secondary|Area Under the Curve From 0 to Infinity (AUC 0-inf )|Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||ng*hr/mL||Standard Deviation|Mean
90593|NCT00904748|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration measured in nanograms per milliliter (ng/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||ng/mL||Standard Deviation|Mean
90594|NCT00904748|Primary|Area Under the Curve (AUC 0-t)|Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.||ng*hr/mL||Standard Deviation|Mean
90595|NCT00904722|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.|Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.||months||95% Confidence Interval|Median
90596|NCT00904722|Primary|Overall Response Rate|Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.|Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.||participants|||Number
90597|NCT00904670|Other Pre-specified|SKAMP Compliance Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
90598|NCT00904670|Other Pre-specified|SKAMP Quality of Work Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
90631|NCT00904150|Primary|Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine|PgR and ESR|6 years|Matched pairs of follicular and luteal samples Not all samples were suitable for analysis for each outcome measure||number of genes expressed||Standard Deviation|Mean
90632|NCT00904150|Primary|Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 C325G|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
90599|NCT00904670|Secondary|SKAMP Combined Scores Over 12 Hours|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Data for combined SKAMP score was collected and reported through the measure of onset and duration of clinical effects as given in outcome measure 2.|||||
90600|NCT00904670|Secondary|Permanent Product Measure of Performance (PERMP) Score Over 12 Hours|The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant’s performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
90601|NCT00904670|Secondary|SKAMP Deportment Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
90602|NCT00904670|Secondary|SKAMP Attention Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
90603|NCT00904670|Secondary|Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale|Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
90604|NCT00904670|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|Hour 4 post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
90605|NCT00904618|Secondary|Safety of the Sling.|Safety of the sling was assessed with a record of perioperative and postoperative complications. The following are all the complications experienced with the TVT-SECUR for each technique, the 'Hammock' technique and the 'U-Method'.|15 months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the ‘U-Method’.||Participants|||Number
90633|NCT00904150|Secondary|SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine|SYNE1|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
90634|NCT00904150|Secondary|Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine|TNF|6 years|Not all samples were suitable for analysis for each outcome measure||participants|||Number
90606|NCT00904618|Secondary|Improvement in Stress Urinary Symptoms.|A questionnaire with a Likert scale from one to five was used to assess the improvement in stress urinary symptoms at six months for each technique, the 'Hammock' technique and the 'U-Method' (1-Worst, 2-Same, 3-Improved, 4-Almost cured, 5-Cured). Patients had to answer 3 or more on the scale to be considered improved.|Six months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Seven patients for the 'Hammock' technique and three patients for the 'U-Method' did not fill out the questionnaire at six months.||participants|||Number
90607|NCT00904618|Primary|Local Anesthesia Satisfaction|Local anesthesia satisfaction was assessed with a questionnaire completed by the patients. The patients were asked if they would recommend this type of anesthesia (yes or no).|Questionnaire filled 1 week after surgery|2 patients did not fill out the questionnaire 1 week after surgery||participants|||Number
90608|NCT00904423|Secondary|Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio||every 4 months|Data are not accessible.|||||
90609|NCT00904423|Secondary|Arthralgias and Myalgias||every 4 months|Data are not accessible.|||||
90610|NCT00904423|Secondary|Bone Turnover Markers||months 4 and 12|Data are not accessible.|||||
90611|NCT00904423|Secondary|Change in Hip Bone Mineral Density (BMD) T-score||one year|Data are not accessible.|||||
90612|NCT00904423|Primary|Spine Bone Mineral Density T Score Change Over One Year||1 year|Data are not accessible.|||||
90613|NCT00904371|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)||Participants|||Number
90614|NCT00904371|Secondary|Number of Patients With Adverse Events (AE)||4-10 months|Treated patients||Participants|||Number
90615|NCT00904371|Secondary|Change in Heart Rate From Baseline to Study End||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status||Beats per minute||Standard Deviation|Mean
90616|NCT00904371|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)|Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)||Percentage of participants|||Number
90617|NCT00904371|Secondary|Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)||Percentage of participants|||Number
90618|NCT00904371|Primary|Change From Baseline in Risk Assessment According to ESH/ESC Guidelines|ESH is the European society of hypertension, and ESC is the European society of cardiology.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||Participants moved into category|||Number
90619|NCT00904371|Primary|Change From Baseline in Framingham Stroke Risk Assessment Score|The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||units on a scale||Standard Deviation|Mean
90620|NCT00904371|Primary|Change From Baseline in Framingham CVD Risk Assessment Score|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||units on a scale||Standard Deviation|Mean
90621|NCT00904371|Primary|Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||units on a scale||Standard Deviation|Mean
90622|NCT00904371|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||mm Hg||Standard Deviation|Mean
90623|NCT00904371|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)||mm Hg||Standard Deviation|Mean
90624|NCT00904215|Primary|Change in WHO-QOL (WHO-Quality Of Life)|"World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed.~Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)"|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|||Units on a scale||Standard Deviation|Mean
90625|NCT00904215|Secondary|Change in VAS (Visual Analog Scale)|VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|||Units on a scale||Standard Deviation|Mean
90626|NCT00904215|Primary|Change in DBP (Diastolic Blood Pressure)|The change of the mean DBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|||mmHg||Standard Deviation|Mean
90627|NCT00904215|Primary|Change in SBP (Systolic Blood Pressure)|The change of the mean SBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|In clinical report form (CRF), some patients' SBP was not recorded.||mmHg||Standard Deviation|Mean
90628|NCT00904189|Secondary|Determination of the Range of Background Signal Measured by the EPR Device.||2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.|||||
90629|NCT00904189|Primary|Mean Dose of Radiation Received by Fingernails|The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).|2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.|||||
90630|NCT00904150|Secondary|Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine|TNF and SYNE1|6 years|Matched luteal and follicular phase samples Not all samples were suitable for analysis for each outcome measure||number of genes expressed||Standard Deviation|Mean
90653|NCT00904007|Primary|Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure|A unique hypertensive period served as the unit of analysis. A hypertensive period started on the first day during the study when a patient’s BP was elevated. It ended on the first subsequent day when it was <140/90 mm Hg or on the last day BP was recorded during the study. Duration of the hypertensive period (days) was the outcome measure. BP measurements obtained in the course of routine care were used to ascertain study outcomes, whether obtained by the PCP or at other clinic visits. These measurements were obtained from structured data (ie, BP recordings in the electronic medical record) and natural language processing of provider notes as previously described. If several measurements were recorded on the same day, the lowest mean arterial BP was used.|Months 1-24|||days||Full Range|Median
90654|NCT00903929|Secondary|Median Number of Platelet Transfusions up to the Day of Engraftment||baseline to day of engraftment|||units of platelets||Full Range|Median
90655|NCT00903929|Secondary|Median Time to Platelet Engraftment|Determined for all participants who completed at least 75% of the planned doses. Platelet engraftment was as defined by the Center for International Blood and Marrow Transplant Research as the first of 3 consecutive days of a platelet count 20,000/mL without platelet trans-fusions for 7 days and/or the first day of a platelet count 100,000/mL without platelet transfusions for 7 days.|1.5 years|||days||Full Range|Median
90656|NCT00903929|Primary|Maximum Tolerated Dose (MTD) of Eltrombopag|The MTD was defined as the highest dose if no dose limiting toxicity was observed, or the highest dose at which less than one-third of the patients experienced toxicities not expected in the standard stem cell transplantation setting.|1.5 years|||mg/day|||Number
90657|NCT00903695|Primary|Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group|IADL is a behavior rating scale using 9 domains of household and community activities, with a total score of 27 points indicating less competence than a normal function score of 9 points. Outcome measure is results of an ANOVA of the differences between baseline and end/last score, by study arm/group, to detect statistically significant differences (nutriceutical vs placebo).|baseline to 12 months|All subjects who completed 12-month study were included.||units on a scale||Standard Error|Mean
90658|NCT00903695|Primary|Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group|ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.) in which a maximum score of 18 indicates less competence than a minimum score of 6 (normal skills). Outcome measure is results of ANOVA of the differences between baseline and last/end scores, by study arm/group, to detect any statistically significant differences.|baseline to 12 months|All subjects who completed 12-month study were included.||units on a scale||Standard Error|Mean
90659|NCT00903695|Primary|Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group|NPI is a behavior rating scale with 12 categories in which a maximum score of 36 points indicates more pathology than a minimum score of 0. Outcome measure reported here is results of an ANOVA of the differences between baseline and end scores, by study arm/group, to detect any statistically significant difference (nutriceutical vs placebo groups) was completed.|baseline to 12 months|All subjects who completed 12-month study were included.||units on a scale||Standard Error|Mean
90660|NCT00903695|Primary|Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group|MiniMental State Exam is a cognitive screening device with possible 30 points in several categories; higher points indicate greater competence. Clinician tests orientation, attention, language, & visuo-spatial construction. Outcome measure is results of an ANOVA of differences between baseline and end/last scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.||units on a scale||Standard Error|Mean
90661|NCT00903695|Primary|Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group|Clock Drawing Test is a cognitive screening instrument in which subjects are to draw a clock and set a specified time. Various scoring methods can be employed using 4 to 15 points, with more points showing more competence. This study used the 8-point scoring method, so that 0-8 points could be assigned during each of the baseline and 4 assessment periods during the 12-month study. ANOVA of the differences between baseline and end scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.||units on a scale||Standard Error|Mean
90662|NCT00903695|Primary|Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group|CDR is a rating scale for 8 aspects of behavior with 0-3 points allowed; higher scores indicate more pathology. Total minimum and maximum scores are 0 and 36 respectively.Clinician rates the patient's behavior and competence with input from family members who live with the patient. ANOVA of differences between baseline and end scores of the CDR scale are reported here, by the study arm/group.|baseline before intervention to 12 months of intervention|All subjects who completed the 12-month study were included (placebo and nutriceutical arms/groups).||units on a scale||Standard Error|Mean
90663|NCT00903695|Primary|Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group|Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.|Baseline and 12 months|All participants who completed 12-month study were included in the ANOVA analysis of the differences in scores of tests between baseline and end assessments.||units on a scale||Standard Deviation|Mean
90664|NCT00903695|Secondary|Number of Subjects Who Converted to Early Alzheimer's (Dementia).|Neurological diagnosis is based on test scores that reach -1.6 SD of mean for age/education, and on radiological tests of brain structure (CT, MRI, PET). Usual cutoff for test score percentile is <0.05 to diagnose dementia.|12 months|Subjects diagnosed as Mild Cognitive Impairment (MCI) in VA clinic were given opportunity to participate in the study if they met inclusion/exclusion criteria (no illnesses that cause brain damage or are uncontrolled such as brittle diabetes).||participants|||Number
90678|NCT00903409|Secondary|Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial|Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial|ITT Population||Percentage change||Full Range|Median
90665|NCT00903682|Secondary|Resistance Determinations|The evolution of viral genotype and phenotype was assessed by the number of patients with resistance-associated mutations emerging at the endpoint. A mutation was considered emerging if it was present at endpoint and not present at baseline or any pre-baseline assessment. (NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; RAM = resistance-associated mutation, IAS-USA = International AIDS Society - USA)|at baseline and all subsequent visits until week 48 in case if virologic failure|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol||number of participants|||Number
90666|NCT00903682|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at baseline and week 2, 6, 12, 24, 36 and 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol||number of cells/L (x10^6)||Standard Error|Mean
90667|NCT00903682|Secondary|Neuropsychiatric Adverse Events by Week 48|The percentage of patients with at least 1 treatment emergent Grade 1 -4 neurologic or psychiatric adverse event, judged by the investigator to be at least possibly related to the study drug.|from baseline to week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||percentage of patients|||Number
90668|NCT00903682|Secondary|Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score|"The HIV Patient Symptoms Profile measures the tolerability of HIV treatment from the patient's perspective, using 14 concept scales in maximum 84 questions. The response options include a no or yes answer to Did symptom occur?. If yes, there is a problem scale which ranges from 1 = I had this symptom and it was not a problem to 5 = I had this symptom and it was a severe problem. A neuropsychiatric tolerability score is composed as the sum of 21 items and ranges from 0 (best) to 105 (worse). A total Tolerability score (ie, the sum of all items) ranges from 0 (best) to 420 (worse)"|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||points on a scale||Standard Error|Mean
90669|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <200 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||Number of participants|||Number
90670|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <50 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.||Number of participants|||Number
90671|NCT00903682|Primary|Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event|Proportion of patients with at least 1 treatment-emergent Grade 1-4 Central Nervous System or psychiatric Adverse Event, observed between Baseline through Week 12 and judged by investigator to be at least possibly related to the study drug in ETR group versus EFV group. All Adverse Events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (“DAIDS AE grading table”). Grade 1-4 covers all severities.|between baseline and 12 weeks|The intent-to-treat (ITT) population has been defined as the set of all patients who were randomized and who have taken at least one dose of trial medication, regardless of their compliance with the protocol.||percentage of patients|||Number
90672|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:~At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurement, or the appearance of one or more new lesion(s)."|6 months after starting treatment|||participants|||Number
90673|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:~At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."|3 months after starting treatment|||participants|||Number
90674|NCT00903630|Primary|Phase 2 - Number of Subjects Achieving a Partial or Complete Response|"Partial response is defined as:~At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.~Complete response is defined as:~The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met."|3 months after starting treatment|||participants|||Number
90675|NCT00903630|Primary|Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.|within 5 weeks of starting treatment|||participants|||Number
90676|NCT00903630|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer|The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).|1 cycle (28 days)|||milligrams (mg)|||Number
90677|NCT00903448|Primary|Mean Percent Time That Gastric pH > 4.0 on Day 5|for 24 hours starting Day 5 for each period|24 hours|This study was a three period, crossover study of 40 subjects entering either treatment sequence ABB or BAA; consequently each subject in the study participated in three periods over which each subject would eventually receive both Prilosec OTC and Prevacid||percent time gastric pH exceeds 4.0||Standard Error|Mean
91394|NCT00892957|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to treat||percentage of participants||95% Confidence Interval|Number
90679|NCT00903409|Secondary|Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in “Switchers” vs. Non-switchers|Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|Months 4, 12, and 24 (LOV111818) of the open-label extension trial|ITT Population||Percent change||Full Range|Median
90680|NCT00903409|Primary|Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)|Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)|Month 4 (LOV111818)|Intent-to-Treat (ITT) Population: Comprised of data for all participants who were enrolled and received at least one dose of study medication||Percent change||Full Range|Median
90681|NCT00903396|Secondary|Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
90682|NCT00903396|Secondary|Tolerability and Adverse Events as Assessed by NCI CTC v 3.0||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
90683|NCT00903396|Secondary|Proportion of Patients Reporting Treatment Failure||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
90684|NCT00903396|Secondary|Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
90685|NCT00903396|Primary|Complete Response (no Episodes of Nausea or Vomiting)||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
90686|NCT00903383|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12|The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population||mm||Standard Deviation|Mean
90687|NCT00903383|Secondary|Change From Baseline in C-reactive Protein (mg/L) at Week 12|The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population||mg/L||Standard Deviation|Mean
90688|NCT00903383|Secondary|Hybrid ACR Response at Week 12|Evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a continuous score of the mean change in core set measures. The percentage improvement from baseline was computed in each of the components of the ACR. The average percent improvement was calculated and used with the subject's ACR20, ACR50, and ACR70 status to compute the hybrid ACR response, with a positive change indicating improvement.|Baseline and 12 weeks|Intent to Treat Population||Percent change||Standard Deviation|Mean
90689|NCT00903383|Secondary|ACR70 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 70% response criteria (ACR70) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR70, there had to be ≥70% improvement in swollen joint count, ≥70% improvement in painful/tender joint count, and ≥70% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population||Participants|||Number
90690|NCT00903383|Secondary|ACR50 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 50% response criteria (ACR50) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR50, there had to be ≥50% improvement in swollen joint count, ≥50% improvement in painful/tender joint count, and ≥50% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population||Participants|||Number
90691|NCT00903383|Primary|ACR20 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population||Participants|||Number
90692|NCT00903370|Secondary|Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge||Less than 30 days post-procedure or hospital discharge|||percentage of patients||95% Confidence Interval|Number
90693|NCT00903370|Primary|Freedom From Atrial Fibrillation||Measured at Month 12|Since the primary analysis is an intent-to-treat, outcomes were imputed for patients with missing data.||percentage of patients||95% Confidence Interval|Number
90694|NCT00903357|Primary|Changes in Urinary EDN|Changes of Urinary EDN(Eosinophil Derived Neurotoxin) after taking Montelukast or placebo drug. Urinary EDN levels were measured using an ELISA (MBL, Woburn, MA, USA) and the intra-assay and inter-assay variations were 3.0 ± 0.5 and 7.7 ± 1.5, respectively. Minimum value: 0, Maximum value: 2040 ng/ml.|18 weeks after participants recruitment|||Urine EDN (ng/ml)||Standard Deviation|Mean
90695|NCT00903357|Primary|Changes in Urinary LTE4|Changes of Urinary LTE4(Leukotrien E4) after taking Montelukast or placebo drug. Urinary LTE4 levels were measured using an enzyme-linked immunoassay (ELISA) (Cayman Chemical, Michigan, USA) and the intra-assay and inter-assay variations were 7.4 ± 2.1 and 12.4 ± 7.8, respectively. Minimum value : 0 Maximum vlaue: 1000 pg/ml.|18 weeks after patient recruitment|||Urinary LTE4 (pg/ml)||Standard Deviation|Mean
90696|NCT00903357|Primary|Changes in SCORAD Index|Changes of SCORAD(SCORing Atopic Dermatitis) index after taking Montelukast or placebo drug. SCORAD calculation: Extent(%)/5 + 7*Intensity/2 + subjective symptoms (minimum score 0, maximum score 103) (SCORAD index >40: severe, 15-40:moderate, <15: mild)|18 weeks after patient recruitment|||units on a scale||Standard Deviation|Mean
90697|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months|difference in the mean|Change from Baseline to 6 Months|||grams/cm^2||Standard Deviation|Mean
90698|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months|difference in mean|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.||grams/cm^2||Standard Deviation|Mean
90699|NCT00903344|Secondary|Change in Bone Mineral Density (BMD) at HIP at 3 Months||Change from Baseline to 3 months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.||grams/cm^2||Standard Deviation|Mean
90700|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 6 Months||Change from Baseline to 6 Months|||ng/ml||Standard Deviation|Mean
90701|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 3 Months|Difference in means between visits|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for two of the groups' participants was not included in the results.||ng/ml||Standard Deviation|Mean
90702|NCT00903344|Primary|Change in Bone Mineral Density (BMD) in HIP at 6 Months||Change from Baseline to 6 months|||grams/cm^2||Standard Deviation|Mean
90703|NCT00903331|Secondary|Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study|"Disease worsening was indicated by pulmonary function test/idiopathic pulmonary fibrosis worsening (PFT/IPF) or acute respiratory decompensation of IPF.~PFT/IPF worsening was indicated by the occurrence of both of the following: confirmed by two tests at least 4 weeks apart, as defined by the occurrence of both of the following: decrease from baseline ≥ 10% in forced vital capacity and decrease from baseline ≥ 15% in corrected diffusing capacity of the lung for carbon monoxide.~Acute respiratory decompensation of IPF was defined as an unexplained rapid deterioration (over a period of less than 4 weeks) of the patient’s condition with increasing shortness of breath requiring oxygen supplementation ≥ 5 L/min to maintain a resting oxygen saturation ≥ 90% or arterial oxygen pressure ≥ 55 mmHg (sea level) or 50 mmHg (high altitude)."|Up to end of study (Up to 24 months)|All randomized patients||participants|||Number
90704|NCT00903331|Primary|Forced Vital Capacity (FVC) at Baseline and End of Period 1|FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient’s measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing.|12 months|All randomized patients||litres||95% Confidence Interval|Median
90705|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Mean
90706|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90707|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
93720|NCT00868140|Primary|Fasting Serum Insulin|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo|baseline|||uIU.min/ml||Standard Error|Mean
90708|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90709|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 - by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90710|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning (PF) Scale of the EORTC QLQ-C30 - by First-Line (1L) Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90711|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First and Second-line Drugs Combined|The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L or 2-L treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90712|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First-line Drug|The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L of treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90713|NCT00903175|Secondary|Duration of Response (DoR) - First-Line (1-L)|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR) during the first-line treatment period. The start date was the date of first documented response (CR or PR) during the first-line treatment and the end date was the date of the event defined as the first documented progression or death due to underlying cancer during or after the same treatment line.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The analysis population corresponds to the patients included in the Full analysis set (i.e. randomized patients analyzed according to the treatment and stratum they were assigned to at randomization) and who achieved a best overall response of CR or PR during the first-line treatment period.||Months||95% Confidence Interval|Median
90714|NCT00903175|Secondary|Overall Response Rate (ORR) - First -Line (1-L)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) and was based on investigator assessment of radiology data per RECIST. Participants with best overall response of ‘Unknown’ were treated as non-responders in the calculation of the ORR. Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Radiological assessments : every 12 weeks until disease progression, the start of another antineoplastic therapy or for any other reason.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||percentage of participants|||Number
90715|NCT00903175|Secondary|Overall Survival (OS)|Overall survival was defined as the time from date of randomization to date of death due to any cause. The analysis of OS included all deaths in the FAS regardless of when they were observed.|Every 2 months from randomization up to 3 years after last patient randomized|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90716|NCT00903175|Secondary|Progression-free Survival Combined (PFS-C)|PFS-C (1L and 2L study drugs combined) was a composite endpoint which combined both lines of study treatment. It was defined as the time from the date of randomization to the first of the following: date of death due to any cause, or date of the first radiologically documented progression disease during or after the second-line treatment period for patients with a radiologically documented progression disease in the first-line treatment period and who had crossed-over to second-line treatment no more than 6 weeks after progression.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to about 56 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90717|NCT00903175|Primary|Progression Free Survival First-Line (PFS 1-L)|PFS_1L based on investigator assessment of radiology data by RECIST 1.0, was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause during or after first-line treatment with everolimus or sunitinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.||Months||95% Confidence Interval|Median
90718|NCT00903162|Secondary|The Effect of OFS Combined With Aromatase Inhibitor Therapy on the Incidence and Severity of Menopausal Symptoms, Sexual Dysfunction, Musculoskeletal Complaints, Other Side Effects and Overall Quality of Life.|OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.|||||
90719|NCT00903162|Secondary|Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.|Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.|||||
90720|NCT00903162|Primary|Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.|The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.|1 year|Between September 15, 2009, and January 18, 2013, 17 patients were enrolled, but only 16 actually began protocol-directed treatment. Of the 16, 4 stopped treatment before completing even 1 year of protocol-directed therapy, owing to toxicity.||participants|||Number
90721|NCT00903032|Primary|Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)|The primary outcome was the proportion of patients who were adherent to cardioprotective medications (beta-blockers, statins, clopidogrel, and ACE/ARB) in the year following ACS hospitalization.|12-months|Composite Adherence* (PDC>0.80) (%)||percentage of participants|||Number
90722|NCT00903006|Primary|Patient Response (+ Time to Disease Progression)||Baseline, after two 28 day cycles, until disease progression.||||||
90723|NCT00903006|Primary|Phase I Maximum Tolerated Dose (MTD) for Dose Level 1|"Maximum Tolerated Dose (MTD) defined as the dose or dose-combination that has the mean posterior toxicity rate closest to the target toxicity rate of 0.33. Dose levels reviewed with each 28 day cycle. Treatment dose levels:~Fulvestrant will be given using a loading dose of 500 mg intramuscularly (IM) on day 1 as two 250 mg/5 ml injections, followed by 500 mg IM on day 15 and on day 1 of each subsequent 28- day (+/- 2 days) cycle.~MK-0646 will be given intravenously on days 1,8, 15, and 22 for each cycle at one of the two dose levels: 1) 5 mg/kg or 2) 10 mg/kg (Dose level 1)~Dasatinib will be given orally (PO) continuously on days 1 -28 for each cycle at one of two dose levels: 1) 70 mg po daily or 2) 100 mg po daily"|28 day cycle|Study terminated early; Analysis not available due to smaller sample size.|||||
90724|NCT00902850|Primary|Clinical Performance|Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.|Insertion, 4 hours & End of Day|All eligible participants||units on a scale|||Number
90725|NCT00902746|Secondary|Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.||units on a scale||Standard Deviation|Mean
90726|NCT00902746|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.||units on a scale||Standard Deviation|Mean
90727|NCT00902668|Primary|Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy|Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale|during the first 5 years after treatment|Due to slow accrual the study was closed to accrual and all 3 participants were terminated. No data was analyzed.|||||
90728|NCT00902564|Secondary|Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks|Observed Cases (OC)||percentage of patients|||Number
90729|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
90730|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
90731|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
90732|NCT00902564|Secondary|Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks|||percentage of patients|||Number
90733|NCT00902564|Secondary|Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks|||percentage of patients|||Number
90734|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
90735|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
90736|NCT00902564|Primary|Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks|||scores on a scale||Standard Deviation|Mean
90737|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
90738|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
90739|NCT00902538|Secondary|In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||Participants|||Number
90740|NCT00902538|Secondary|In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
90741|NCT00902538|Secondary|In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.||mm Hg||Standard Error|Least Squares Mean
90742|NCT00902538|Secondary|Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
90743|NCT00902538|Secondary|Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
90744|NCT00902538|Secondary|Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.|Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|baseline (week 8) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||Participants|||Number
90745|NCT00902538|Secondary|Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
90746|NCT00902538|Primary|Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.||mm Hg||Standard Error|Least Squares Mean
90747|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at End of Chemotherapy for quality of life scores.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||correlation coefficient|||Number
90748|NCT00902330|Secondary|Effects of Treatment on Quality of Life - Means at End of Treatment|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not al all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|up to 2 weeks after completion of study treatment, for up to 8 months|||units on a scale||Standard Error|Least Squares Mean
90749|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at end of Chemotherapy for symptoms.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||correlation coefficient|||Number
90750|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||units on a scale||Standard Deviation|Mean
90751|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment|Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks afer completion of study treatment, for up to 8 months|||correlation coefficient|||Number
90752|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed after completion of study treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks after completion of study treatment, for up to 8 months|||Log (pg/ml)||Standard Deviation|Mean
90753|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores.|Midpoint Chemotherapy, up to 4 months|||correlation coefficient|||Number
90754|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Midpoint Chemotherapy, up to 4 months|||units on a scale||Standard Deviation|Mean
90755|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for symptoms.|Midpoint Chemotherapy, up to 4 months|||correlation coefficient|||Number
90756|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Midpoint Chemotherapy, up to 4 months|||units on a scale||Standard Deviation|Mean
90757|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months|||correlation coefficient|||Number
90758|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months|||Log (pg/ml)||Standard Deviation|Mean
90759|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Baseline|Simple correlations will be computed at Baseline for quality of life scores.|Baseline|||correlation coefficient|||Number
90760|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Baseline|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Baseline|||units on a scale||Standard Deviation|Mean
90761|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy|Simple correlations will be computed at Baseline Chemotherapy for symptoms.|Baseline|||correlation coefficient|||Number
90762|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Baseline|||units on a scale||Standard Deviation|Mean
90763|NCT00902330|Secondary|Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline|||correlation coefficient|||Number
90764|NCT00902330|Secondary|Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline|Per protocol, for all subjects with available data. No imputation was utilized.||Log(pg/ml)||Standard Deviation|Mean
90765|NCT00902330|Secondary|To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.|Examine correlations between the symptoms at baseline to determine a general pattern of association. Factor analysis (a statistical method used to describe variability among observed, correlated variables in terms of a potentially lower number of unobserved variables called factors) was performed to examine how these 5 symptoms cluster. A principal component factor analysis was performed on the correlation matrix for the symptom scores of anxiety, depression, pain, fatigue and sleep disturbance at up to two weeks after completion of study treatment, up to 8 months). For each analysis two factors were retained that explained 74% of the variability for the baseline symptom scores, 79% of the variability of the symptom scores at the midpoint and 78% of the variability in symptom scores at study completion. A varimax rotation was utilized and the factor loadings from the varimax rotation were reported.|up to 2 weeks after completion of study treatment, for up to 8 months|||Rotated factor loading multiplied by 100|||Number
91011|NCT00897104|Secondary|Participants Who Used Escape Medication 2 Hours After the Treatment Dose|Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
90766|NCT00902330|Primary|Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer|Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire|Up to 2 weeks afer completion of study treatment, for up to 8 months|||units on a scale||Standard Deviation|Least Squares Mean
90767|NCT00902304|Secondary|Number of Patients With Major Clinical Endpoints|Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure).|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.||participants|||Number
90768|NCT00902304|Secondary|Rate of Treatment Compliance|The rate of compliance was planned to be estimated from the quantity of unused medication returned at each scheduled visit over the entire follow-up period. Rate of compliance = (tablets supplied - tablets returned)/(tablets for 100% compliance).|26 weeks|This data will not be analyzed due to the poor quality of the data.|||||
90769|NCT00902304|Secondary|Change in Self-care Behavior Score From Baseline to Week 26|A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||Change in score||Standard Deviation|Mean
90770|NCT00902304|Secondary|Participants With End Organ Disease at Baseline and Week 26|"A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio > 30mg/mol or 24h urine protein > 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio > 25mg/mol(male) or >35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values >= 38mm).~Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage.~It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks)."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.||participants|||Number
90771|NCT00902304|Secondary|Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26|"The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression.~The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||change in CES-D score||Standard Deviation|Mean
90772|NCT00902304|Secondary|Number of Patients With Depression|Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||participants|||Number
90773|NCT00902304|Secondary|Change in the EQ-5D Score|The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||change in EQ-5D score||95% Confidence Interval|Mean
90774|NCT00902304|Secondary|Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments|A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.||Participants|||Number
90775|NCT00902304|Secondary|Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy|The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset.|26 weeks|Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment.||participants|||Number
90776|NCT00902304|Secondary|Change in Absolute Cardiovascular Risk Score|"The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of <10% is a low risk, 10 to 15% is a moderate risk, and >15% is a high risk.~A decrease indicates improvement."|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.||percentage risk score change||Standard Deviation|Mean
90777|NCT00902304|Secondary|Change in Mean Sitting Diastolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.||mmHg||95% Confidence Interval|Least Squares Mean
90778|NCT00902304|Secondary|Change in Mean Sitting Systolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.||mmHg||95% Confidence Interval|Least Squares Mean
90779|NCT00902304|Primary|Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target|BP target groups were: <= 125/75mmHg, <= 130/80mmHg and <= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.||percentage of participants|||Number
90780|NCT00902265|Secondary|Participants With Treatment Emergent Adverse Events (AEs)||Week 1 to Week 12|Safety Population, consisting of participants who took at least one dose of desmopressin||Participants|||Number
90781|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
90782|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
90783|NCT00902265|Secondary|Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12|The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
90784|NCT00902265|Secondary|Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).||Units on a scale||Standard Deviation|Mean
91395|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to treat||percentage of participants||95% Confidence Interval|Number
90785|NCT00902265|Secondary|Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||Units on a scale||Standard Deviation|Mean
90786|NCT00902265|Secondary|Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12|Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 – baseline.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||Hours||Standard Deviation|Mean
90787|NCT00902265|Secondary|Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12|The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||ratio||Standard Deviation|Mean
90788|NCT00902265|Primary|Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12|The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)||Number of nocturnal voids||Standard Deviation|Mean
90789|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
90790|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
90791|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes.||scores on a scale||Standard Deviation|Mean
90792|NCT00902226|Secondary|Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks|||percentage of patients|||Number
90793|NCT00902226|Secondary|Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks|||percentage of patients|||Number
90794|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
90795|NCT00902226|Primary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks|||scores on a scale||Standard Deviation|Mean
90796|NCT00902174|Secondary|Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.~The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.||ng/mL||Standard Deviation|Mean
90808|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure|Change from baseline in mean pulmonary arterial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The mean pulmonary arterial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher mean pulmonary arterial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis||mm Hg||Standard Error|Least Squares Mean
90797|NCT00902174|Secondary|Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.~The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.||ng/mL||Standard Deviation|Mean
90798|NCT00902174|Secondary|Covariance of End of Study CAMPHOR Score|The CAMPHOR test consists of 65 items and 3 scales. Two scales measure Health Related Quality of Life. 1) Symptoms: consists of 25 items measuring loss or abnormality of psychological, physiological or anatomical structure or function; further sub-divided into 3 subscales (energy, breathlessness and mood), 2) Disability: consists of 15 items measuring any restriction or lack of ability to perform an activity. 3) Quality of Life (QOL): consists of 25 items defining how individuals perceived ability and capacity to satisfy their needs. The 25-item symptom and QOL scales score from 0-25 where a higher score indicates the presence of more symptoms and poor QOL, respectively. The 15-item functioning scale scores 0-30; a higher score indicates poor functioning.|Week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Error|Least Squares Mean
90799|NCT00902174|Secondary|Change in Borg Dyspnea Score During 6-minute Walk Test|Change in Borg scale was measured at different time points at week 24. The Borg Scale consists of scale range of 0 to 10. Participants pointed to indicate their level of dyspnea before and at the end of exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). A reduction in this score indicates an improvement.|week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||units on a scale||Standard Deviation|Mean
90800|NCT00902174|Secondary|Change From Baseline in Heart Rate|Change from baseline in heart rate (bpm) was measured via right heart catheterization according to the local hospital procedures. The heart rate was assessed when the participant was in a stable hemodynamic rest state.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||bpm||Standard Error|Least Squares Mean
90801|NCT00902174|Secondary|Change From Baseline in Diastolic Arterial Blood Pressure|Change from baseline in diastolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The diastolic arterial blood pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
90802|NCT00902174|Secondary|Change From Baseline in Systolic Arterial Blood Pressure|Change from baseline in systolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The systolic arterial blood was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
90803|NCT00902174|Secondary|Change From Baseline in Cardiac Output|Change from baseline in cardiac output (L/min) was measured via right heart catheterization according to the local hospital procedures. The cardiac output was assessed when the participant was in a stable hemodynamic rest state. An increase from baseline (higher number) in cardiac output indicates improvement.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||Liters/minute||Standard Error|Least Squares Mean
90804|NCT00902174|Secondary|Change From Baseline in Pulmonary Resistance Index|Change from baseline in pulmonary resistance index (dynes*sec*cm^-5/m2) was measured via right heart catheterization according to the local hospital procedures. The pulmonary resistance index was assessed when the participant was in a stable hemodynamic rest state. A reduction from baseline in pulmonary resistance index indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||dynes*sec*cm^-5/m2||Standard Error|Least Squares Mean
90805|NCT00902174|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Change from baseline in pulmonary vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The pulmonary vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in pulmonary vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||dynes*sec*cm^-5||Standard Error|Least Squares Mean
90806|NCT00902174|Secondary|Change From Baseline in Systemic Vascular Resistance|Change from baseline in systemic vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The systemic vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in mean systemic vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||dynes*sec*cm^-5||Standard Error|Least Squares Mean
90807|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Capillary Wedge Pressure|Change from baseline in mean pulmonary capillary wedge pressure (mmHg)was measured via right heart catheterization according to the local hospital procedures. The right atrial mean pulmonary capillary wedge pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
91396|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application|Intent to treat||percentage of participants||95% Confidence Interval|Number
90809|NCT00902174|Secondary|Change From Baseline in Right Atrial Pressure|Change from baseline in right atrial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The right atrial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher right atrial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.||mm Hg||Standard Error|Least Squares Mean
90810|NCT00902174|Secondary|Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases|Clinical worsening per participant was measured by the onset of any adjudicated event (all cause mortality; overnight hospitalization for worsening of Pulmonary Arterial Hypertension (PAH); worsening of WHO functional class by one level; 15% decline in Six Minute Walk Distance (6MWD) measured on two consecutive occasions) at 24 weeks treatment, comparing imatinib to placebo groups. A cox regression analysis model was used.|24 weeks|The Full Analysis Set included all participants who received at least one dose of study drug and experienced an adjudicated event. A cox regression analysis model was used.||percentage of participants|||Number
90811|NCT00902174|Primary|Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks|This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.|24 weeks|The Full Analysis Set includes all participants who received at least one dose of study drug and completed the 6MWD Six-minute walk test at week 24. Repeated measurement model was used for this analysis.||meters||Standard Error|Least Squares Mean
90812|NCT00902161|Secondary|Number of Participants Who Discontinued Study Treatment Due To AEs|"An AE was defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)|All treated participants||participants|||Number
90813|NCT00902161|Secondary|Number of Participants With An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).|All treated participants||participants|||Number
90814|NCT00902161|Secondary|Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893|Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve|From time of MK0893 administration through estimated 32 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.||nM||Standard Deviation|Mean
90815|NCT00902161|Secondary|Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893|"Cmax was the maximum or “peak” concentration of MK0893 observed after its administration.~Approximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC [8-12]) ÷ 4"|From time of MK0893 administration through 24 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.||uM||Standard Deviation|Mean
90816|NCT00902161|Primary|Recovery Time (Rt[65] From Insulin-induced Hypoglycemia|Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes|From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes|21 participants who received MK0893 + Propanolol while on study had data available, and 17 participants who received Placebo + Propanolol while on study had data available||minutes||95% Confidence Interval|Least Squares Mean
90817|NCT00901901|Other Pre-specified|Tumor Response|Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response [CR] or partial response [PR], according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants||Participants|||Number
90818|NCT00901901|Other Pre-specified|Time to Response|Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Time to response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.||Days||95% Confidence Interval|Median
90819|NCT00901901|Other Pre-specified|Duration of Response|Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Duration of response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.||Days||95% Confidence Interval|Median
90820|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS|Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.|The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants||Scores on a scale||95% Confidence Interval|Least Squares Mean
90821|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index|The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.|The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants||Scores on a scale||95% Confidence Interval|Least Squares Mean
90822|NCT00901901|Secondary|Disease Control|Disease control was defined as the number of participants who had a best response rating of complet response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants||Participants|||Number
90823|NCT00901901|Secondary|Time to Radiological Tumor Progression (TTP)|TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants||Days||95% Confidence Interval|Median
90824|NCT00901901|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.|From randomization of the first patient until 34 months or date of death of any cause whichever came first|The full analysis set (FAS), which was defined as all randomized participants||Days||95% Confidence Interval|Median
90825|NCT00901628|Secondary|Maximal Flexion Angle Degree on Postoperative 7 Day|An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day|postoperative 7 day|||degree||Standard Deviation|Mean
90826|NCT00901628|Secondary|The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended||24 hours postoperative|||participants|||Number
90827|NCT00901628|Secondary|the Proportion of Patients Who Were Satisfied With the Pain Management||postoperative 7 day|||participants|||Number
90828|NCT00901628|Secondary|Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery|An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.|24 hours after surgery|||participants|||Number
90829|NCT00901628|Secondary|Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery|Fentanyl based PCA consumption via PCA pump (microgram)|24 hours postoperative|||microgram||Standard Deviation|Mean
90830|NCT00901628|Primary|Pain( Visual Analog Scale )|An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.|the night after surgery|||units on a scale||Standard Deviation|Mean
90831|NCT00901576|Primary|T 1/2 of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
90832|NCT00901576|Primary|Tmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
90833|NCT00901576|Primary|AUC of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
90834|NCT00901576|Primary|Cmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng/ml||Standard Deviation|Mean
90835|NCT00901576|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
90836|NCT00901576|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||hours||Standard Deviation|Mean
90837|NCT00901576|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP||ng*h/ml||Standard Deviation|Mean
90838|NCT00901576|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-methylphenidate. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.||ng/ml||Standard Deviation|Mean
90839|NCT00901459|Secondary|Change in Craving for Cigarettes After Controlled Smoke Presentations.|Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire (“Did it immediately reduce your craving for cigarettes?”) after smoking presentations through the controlled puff volume apparatus.|After smoking a cigarette through the controlled puff volume apparatus during rTMS|||units on a scale||Standard Deviation|Mean
90840|NCT00901459|Primary|Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.|Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING (“urges to smoke,” “miss a cigarette,” and “crave cigarettes”), MOOD (“calm,” “tense,” and “irritable”), AROUSAL (“wide awake,” “able to concentrate”), and HUNGER (“feel hungry”). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving.|Following exposure to in vivo cues|A repeated measures design exposed participants to three different rTMS conditions over 3 separate visits, with order counterbalanced using latin square design.||units on a scale||Standard Error|Mean
90841|NCT00901316|Primary|Medically Attended Skin and Soft Tissue Infections (MA-SSI)|Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.|From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.|||percentage of partipants||95% Confidence Interval|Number
90842|NCT00901225|Secondary|Platelet Engraftment|Days to platelet count >20,000|12 months|||days||Full Range|Median
90843|NCT00901225|Secondary|Number of Subjects Experiencing Durability of Engraftment|Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.|12 months|||participants|||Number
90844|NCT00901225|Secondary|Days to Absolute Neutrophil Count >500||12 months|||days||Full Range|Median
90845|NCT00901225|Secondary|Number of Subjects Experiencing Graft Failure|To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).|12 months|||participants|||Number
90846|NCT00901225|Secondary|Number of Participants Experiencing a Grade III/IV Toxicity|Safety of plerixafor as measured by Grade III/IV Toxicity|6 months post transplant or until relapse|||participants|||Number
90847|NCT00901225|Primary|Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.||5 days after receiving G-CSF|||participants|||Number
90848|NCT00901186|Secondary|Percentage of CRT Change From Baseline by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.||Percentage change||Standard Deviation|Mean
90849|NCT00901186|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.||micrometers||Standard Deviation|Mean
90850|NCT00901186|Secondary|Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.|VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.||Percentage of participants|||Number
90851|NCT00901186|Secondary|Evolution of Mean Change From Baseline in BCVA by Study Visit|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month BCVA values were included in the analysis.||letters||Standard Deviation|Mean
90852|NCT00901186|Secondary|Percentage of Participants With Improvement in BCVA|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.||Percentage of participants|||Number
90853|NCT00901186|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, 12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. Participants who had both Baseline and Month 12 BCVA values only were included in this analysis.||letters||Standard Deviation|Mean
94466|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 1|Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg|baseline, week 1|FAS (LOCF)||participants|||Number
90854|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|12 months|||% of implants|||Number
90855|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility (based on hand testing)~Absence of a peri-implant infection with suppuration.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|12 months|||% of implants|||Number
90856|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|6 Months|||% of implants|||Number
90857|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility (based on hand testing)~Absence of a peri-implant infection with suppuration.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|6 months|||% of implants|||Number
90858|NCT00901017|Primary|Change of Vertical Height of Buccal Defects|Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery|Baseline to 26 weeks|14 patients represented the ITT population.||mm||95% Confidence Interval|Mean
90859|NCT00900822|Secondary|Implant Success Rate|Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.|12 months after loading the implant|||percentage of implants|||Number
90860|NCT00900822|Primary|Histologically Measured Bone to Implant Contact (BIC)|Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone|9 months after implant placement|This was a split-mouth design. Each patient received both treatments. There was one sample in the Straumann BoneCeramic group that could not be analyzed.||percentage of total surface||Standard Deviation|Mean
90861|NCT00900822|Secondary|Implant Survival Rate|The percentage of implants remaining in the jaw.|12 months after loading the implant|||percentage of implants|||Number
90862|NCT00900796|Secondary|Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by ASAS 40 and who received second anti-TNF treatment for at least 16 weeks (Phase 2).||percentage of participants|||Number
90863|NCT00900796|Secondary|Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy||Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
90864|NCT00900796|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).||percentage of participants||95% Confidence Interval|Number
90865|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator’s criteria.|Week 16|Analysis population included all participants enrolled in study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting first anti-TNF treatment (Phase 1). N (number of participants analyzed) signifies those participants who had low probability of response and were evaluable for the measure.||percentage of participants||95% Confidence Interval|Number
94467|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 2|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 2|FAS (LOCF)||participants|||Number
90866|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator’s criteria.|Week 32|Data was not analyzed as no participant met the criteria for low probability of response in phase 2 of the study.||percentage of participants||95% Confidence Interval|Number
90867|NCT00900796|Secondary|Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment|High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by the investigator and who received second anti-TNF treatment for at least 16 weeks (Phase 2).||percentage of participants||95% Confidence Interval|Number
90868|NCT00900796|Primary|Percentage of Participants With a Clinical Response|Assessment of clinical response was as per investigator’s discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).||percentage of participants||95% Confidence Interval|Number
90869|NCT00900757|Secondary|Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks|||percentage of participants|||Number
90870|NCT00900757|Secondary|Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks|||percentage of participants|||Number
90871|NCT00900757|Secondary|Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment|The FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.|6 weeks|||units on a scale||95% Confidence Interval|Mean
90872|NCT00900757|Secondary|Complete Response|The percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).|6 weeks|||percentage of participants||95% Confidence Interval|Number
90873|NCT00900757|Primary|Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity|The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.|6 weeks|||participants|||Number
90874|NCT00900731|Secondary|Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment|A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Up to 12 weeks|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.||Percentage of days||Standard Error|Least Squares Mean
90875|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.||Puffs||Standard Error|Least Squares Mean
90876|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.||Puffs||Standard Error|Least Squares Mean
90877|NCT00900731|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.||Puffs||Standard Error|Least Squares Mean
90878|NCT00900731|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.||Score on a scale||Standard Error|Least Squares Mean
90879|NCT00900731|Secondary|Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.||Score on a scale||Standard Error|Least Squares Mean
90880|NCT00900731|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|5 minutes to 4 hours post-dose at the end of treatment (week 12)|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure.||Liter||Standard Error|Least Squares Mean
90881|NCT00900731|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|End of treatment (Week 12)|Per-protocol population included all participants who received at least one dose of study medication without any major protocol deviations. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data were imputed using last observation carried forward.||Liters||Standard Error|Least Squares Mean
90882|NCT00900666|Secondary|Gait Function (Based on 6-Minute Walk)|Average walking speed as calculated during a 6-min walk|baseline, 1-mo and 4-mo post-injection|intention to treat||meters/sec||Standard Deviation|Mean
90883|NCT00900666|Primary|Mean Peak Knee Flexion During Swing Phase of Gait|Measured via computerized gait analysis, the average of peak knee flexion during swing phase.|baseline, 1-month and 4-month post-injection|||degrees||Standard Deviation|Mean
90884|NCT00900627|Secondary|Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The time from the date of randomization until the date of death due to any cause.|Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012|Full Analysis Set||Months|Participants|Inter-Quartile Range|Median
90921|NCT00899678|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)|"The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn’s Disease (CD).~Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).||ratio||95% Confidence Interval|Geometric Mean
90885|NCT00900627|Secondary|Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Evaluable for response set (EFR set is all FAS patients with measureable disease at baseline)||Participants|||Number
90886|NCT00900627|Primary|Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Full Analysis Set||Months|Participants|Inter-Quartile Range|Median
90887|NCT00900627|Primary|Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel|DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.|Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant|Safety population (all participants who received at least one dose)||Number of Dose Limiting Toxicities|||Number
90888|NCT00900237|Primary|AUC0-t AUC From Time Zero to the Last Sampling Time|AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h|||ng.h/mL||Standard Deviation|Mean
90889|NCT00900237|Primary|Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid|Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h|||ng/mL||Standard Deviation|Mean
90890|NCT00900146|Primary|Change From Baseline in Dynamic Phase Secreted Insulin Per Unit of Glucose Concentration (Φd) Over 4 Months (Period III)|This was planned as interim analysis and was not conducted because the study was terminated in period III.|Baseline, Over Month 4|The benefit of canakinumab for the treatment of patients with type 2 diabetes mellitus in combination with metformin was inadequate to continue patients into Period IV in the present study, and therefore decided to terminate the study during Period III.||pmol/min/m2/mmol* hour/L||Standard Error|Least Squares Mean
90891|NCT00900146|Secondary|Percentage Change From Baseline in Fasting Lipids Profile at Month 4 (Period II)|The fasting lipid profiles included triglycerides, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), calculated very low-density lipoprotein (VLDL), non-HDL cholesterol. Percentage change was measured as [(value at month 4 – baseline value)/baseline value]*100%. The analysis of covariance model included treatment and metformin dose group as main effects and baseline triglycerides, total cholesterol, LDL, HDL, VLDL and non-HDL as covariates.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who randomized in error, did not receive study drug. LOCF method was used for patients without Month 4 data for any reason and who used rescue drug or any other glucose lowering agents other than metformin. 'n' = patients with baseline and endpoints data.||percent change||Standard Error|Least Squares Mean
90892|NCT00900146|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at Month 4 (Period II)|The change from baseline in hsCRP (on the logarithmic scale) at Month 4 was measured for this analysis. The analysis of covariance included treatment and metformin dose group as main effects and baseline hsCRP as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||log (mg/L)||Standard Error|Least Squares Mean
90893|NCT00900146|Secondary|Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Month 4 (Period II)|The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects, the mean score ± SE is 0.366 ± 0.029. The analysis of covariance included treatment and metformin dose group as main effects and baseline QUICKI as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||units on a scale||Standard Error|Least Squares Mean
90922|NCT00899678|Secondary|Erythrocyte Sedimentation Rate (ESR) at Week 62|The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn’s Disease (CD).|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).||mm/h||95% Confidence Interval|Geometric Mean
90894|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment Insulin Resistance (HOMA2 IR) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance which is the reciprocal of insulin sensitivity (%S)(100/%S)as a percentage of a normal reference population (normal young adults). The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA2 IR as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||percentage of insulin resistance||Standard Error|Least Squares Mean
90895|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment B (HOMA2 B) Beta Cell Function (%B) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). Time profile of postprandial glucose, insulin and C-peptide were assessed as measures of β-cell response to stimulation. The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA-B as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||percentage of beta cell function||Standard Error|Least Squares Mean
90896|NCT00900146|Secondary|Change From Baseline in Fasting Insulin at Month 4 (Period II)|Change in fasting insulin Level measured from blood samples taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting insulin level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/L||Standard Error|Least Squares Mean
90897|NCT00900146|Secondary|Change From Baseline in Fasting Plasma Glucose at Month 4 (Period II)|Change in Fasting Glucose Level measured from plasma taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
90898|NCT00900146|Secondary|Change From Baseline in Average Plasma Glucose Level (7-point Glucose Testing) at Month 4 (Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: Month 0 (Baseline), Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. Patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline average plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
90899|NCT00900146|Secondary|Change From Baseline in Peak Plasma Glucose Level (7-point Glucose Testing) at Month 4(Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: baseline, Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. The patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
90900|NCT00900146|Secondary|Change From Baseline in 2 Hour Insulin Secretion Rate Derived Based on Glucose and C-peptide Following at Month 4 Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. A 2 hour insulin secretion rate using deconvolution was performed. The deconvolution was an algorithm that analyzed the insulin secretion rate relative to glucose and C-peptide combined. Blood samples were taken prior to and after meal at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2 hour Insulin secretion rate as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/min/m²||Standard Error|Least Squares Mean
90923|NCT00899678|Secondary|Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)|"The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn’s Disease (CD).~Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.||ratio||95% Confidence Interval|Geometric Mean
90901|NCT00900146|Secondary|Change From Baseline in Insulin Secretion Rates Relative to Glucose AUC (0-2 Hours) at Month 4 Following Meal Test (Period II)|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. A standard liquid mixed-meal challenge was done at baseline and Month 4. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The model of analysis of covariance included baseline Insulin secretion rate relative to glucose AUC at 0-2 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/min/m²/mmol *hour/L||Standard Error|Least Squares Mean
90902|NCT00900146|Secondary|Change From Baseline in Peak Insulin Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour insulin level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol/L||Standard Error|Least Squares Mean
90903|NCT00900146|Secondary|Change From Baseline in Peak C-peptide Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on the day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak C-peptide level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||nmol/L||Standard Error|Least Squares Mean
90904|NCT00900146|Secondary|Change From Baseline in Peak Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
90905|NCT00900146|Secondary|Change From Baseline in 2-hour Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol/L||Standard Error|Least Squares Mean
90906|NCT00900146|Secondary|Change From Baseline in Insulin Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. Model of analysis of covariance included baseline insulin AUC 0-4 hours as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||pmol*hour/L||Standard Error|Least Squares Mean
90907|NCT00900146|Secondary|Change From Baseline in Prandial Plasma Glucose Area Under Curve (AUC0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Glucose levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The model of analysis of covariance included baseline plasma glucose AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||mmol*hour/L||Standard Error|Least Squares Mean
94468|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 1|Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg|baseline, week 1|FAS (LOCF)||participants|||Number
90908|NCT00900146|Secondary|Change From Baseline in C-peptide Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to start of meal. C-peptide levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The analysis of covariance included baseline C-peptide AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||nmol*hour/L||Standard Error|Least Squares Mean
90909|NCT00900146|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II)|HbA1c was measured by National glycohemoglobin standardization program (NGSP) certified methodology. HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. The analysis of covariance (ANCOVA) included treatment and metformin dose group as main effects and baseline HbA1c as a covariate.|Baseline, Month 4|The full analysis set (included all randomized patients except for mis-randomized patients who randomized in error but did not receive study drug. Last observation carried forward (LOCF) method was used for patients without Month 4 HbA1c data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.||percentage of hemoglobin A1c||Standard Error|Least Squares Mean
90910|NCT00900146|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|4 months (Period II)|The safety set (SAF) included all patients who received at least one dose of study medication during Period II.||Participants|||Number
90911|NCT00900029|Primary|Number of Subjects With Target Wound Closed for the First Time During the Study Period.|At each visit the status of open target ulcers was evaluated as “remained open” or “closed”.|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.||participants|||Number
90912|NCT00900029|Primary|The Number of Participants With Closed Target Ulcers at Each Visit|At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.||participants|||Number
90913|NCT00899717|Secondary|Condylar Path Angles|Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.|Baseline|||degrees||Standard Deviation|Mean
90914|NCT00899717|Secondary|Maximum Mouth Opening (mm)|Maximum voluntary unassisted mouth opening|6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up|||mm||Standard Deviation|Mean
90915|NCT00899717|Secondary|Preferred Chewing Side|The change in the habitual chewing side of each participant across the study|Before and 6 months after therapy|||participants|||Number
90916|NCT00899717|Secondary|Symptom Checklist-90-Revised (SCL-90-R®)|Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.|Before and 6 months after therapy|Only tests from 15 participants were suitable because of slow or too many positive responses.||units on a scale||Standard Deviation|Mean
90917|NCT00899717|Primary|Visual Analogic Scale for Pain Intensity (0-10)|"The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0=No pain and 10=Worst imaginable pain"|Baseline, immediately after therapy, 3 months and 6 months after therapy|||units on a scale||Standard Deviation|Mean
90918|NCT00899678|Secondary|Percentage of Subjects in Corticosteroid-free Remission at the End of the Study|Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn’s Disease Activity index (PCDAI) data is available.|Last/Withdrawal Visit (up to Week 62)|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.||percentage of paticipants||95% Confidence Interval|Number
90919|NCT00899678|Secondary|Percentage of Subjects Who Initiated Steroid Tapering|Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject’s dose.|From Week 2 up to Week 8|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.||percentage of subjects||95% Confidence Interval|Number
90920|NCT00899678|Secondary|Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)|The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.|From Week 0 to Week 62|Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores.||participants|||Number
90924|NCT00899678|Secondary|C-Reactive Protein (CRP) Levels at Week 62|The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn’s Disease (CD)|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.||mg/L||95% Confidence Interval|Geometric Mean
90925|NCT00899678|Secondary|Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)|"Clinical response is defined as a decrease from Week 0 in Pediatric Crohn’s Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points.~The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|From Week 0 to Week 62|Full Analysis Set (FAS) population||percentage of participants||95% Confidence Interval|Number
90926|NCT00899678|Secondary|Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)|"The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.~A negative value in change from Baseline indicates an improvement from Baseline to Week 62."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.||units on a scale||Standard Deviation|Mean
90927|NCT00899678|Secondary|Absolute Pediatric Crohn’s Disease Activity Index (PCDAI) Scores at Week 62|The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.||Score on a scale||Standard Deviation|Mean
90928|NCT00899678|Primary|Percentage of Subjects in Clinical Remission at Week 62|"Clinical remission is defined as a Pediatric Crohn’s Disease Activity Index (PCDAI) score ≤ 10.~The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|Week 62|Full Analysis Set (FAS) population||percentage of participants||95% Confidence Interval|Number
90929|NCT00899600|Secondary|Complications Related to Ketamine||24 and 48 hours||||||
90930|NCT00899600|Secondary|Hemodynamic Changes||24 and 48 hours||||||
90931|NCT00899600|Secondary|Mortality||1 year||||||
90932|NCT00899600|Secondary|Hospital Duration||24 and 48 hours||||||
90933|NCT00899600|Primary|Morphine Consumption in the First 48 Hours After Surgery|Total morphine(mg)consumed at 48 hours.|48 hours|See methodology||mg||Standard Deviation|Mean
90934|NCT00899574|Secondary|Clinical Benefits|This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.||patients|||Number
90935|NCT00899574|Primary|Objective Response (Complete Clinical Response+ Partial Response)|This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.||percentage of patients||95% Confidence Interval|Number
90936|NCT00899470|Secondary|Number of Participant With Clinically Relevant Physical Examination Abnormalities|A physical examination was conducted which included height and weight measurements, from which the Body Mass Index was determined. Physical examination abnormalities were judged to be of medical importance by the Investigator.|Screen, Period 1 Day -1, prior to discharge|All Treated Participants||participants|||Number
90937|NCT00899470|Secondary|Number of Participants With Clinically Relevant Vital Sign Abnormalities|Mean systolic and diastolic blood pressure, heart rate, respiration, and temperature were assessed.Vital sign abnormalities abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants||participants|||Number
90938|NCT00899470|Secondary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities|PR interval, QRS complex, width of QRS, QT interval, and QT corrected for heart rate adjusting for heart rate using either Bazett formula or Fridericia formula were measured. ECG abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants||participants|||Number
90939|NCT00899470|Secondary|Number of Participants With Laboratory Marked Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Leukocytes: <0.9 x LLN/ >1.2 x ULN; blood urea nitrogen (BUN): >1.1 x ULN; creatinine: >1.33 x BL; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN; creatinine kinase (CK): >1.5 x ULN; urine blood=use ≥2 x BL if value ≥2+ or BL1+|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants||participants|||Number
90940|NCT00899470|Secondary|Number of Participants With at Least 1 Adverse Event (AE), Death, Serious AE (SAE), or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants||participants|||Number
92763|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.|two days|||scores|Participants|Standard Deviation|Mean
90941|NCT00899470|Secondary|BMS-510849 Mean T-half and T-max|T-half and Tmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administerd as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||hours||Standard Deviation|Mean
90942|NCT00899470|Secondary|BMS-510849 Mean AUC (0-INF)|AUC (0-T)= for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
90943|NCT00899470|Secondary|BMS-510849 Mean AUC (0-T)|AUC (0-T) for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administration as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
90944|NCT00899470|Secondary|BMS-510849 Mean Cmax|Cmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng/mL||Standard Deviation|Mean
90945|NCT00899470|Primary|Metformin T-half and T-max|T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||hours||Standard Deviation|Mean
90946|NCT00899470|Primary|Metformin Mean AUC(0-INF)|AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
90947|NCT00899470|Primary|Metformin Mean AUC (0-T)|AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
90948|NCT00899470|Primary|Metformin Mean Cmax|Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng/mL||Standard Deviation|Mean
90949|NCT00899470|Primary|Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)|T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||hours||Standard Deviation|Mean
90950|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
90951|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng*h/mL||Standard Deviation|Mean
90952|NCT00899470|Primary|Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)|Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug||ng/mL||Standard Deviation|Mean
90953|NCT00899392|Secondary|GI Suite Flow Efficiency Measured in 15 Minute Increments||At completion of study||||||
90954|NCT00899392|Secondary|Questions Asked by Subjects (Parents)|Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.|Questions written by parents during the end of consent process (48-72 hours)|||Questions||Full Range|Mean
90955|NCT00899392|Secondary|Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)|s-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.|12-18 hours (Night before Endoscopy to Day of Endoscopy)|Matched pairs (pre consent and post consent), Pilot data included to increase power analysis||Units on a Scale (STAI Score)||Standard Deviation|Mean
90956|NCT00899392|Secondary|Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)|Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.|Every 1-2 months|(Consent Group + some pilot participants to increase power of analysis)||Units on a scale||Standard Deviation|Mean
90957|NCT00899392|Primary|Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)|"Units on a scale (score) as Measured by Consent 20 Instrument.~20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points.~Measures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40"|Every 1-2 months|||Units on a scale||Standard Deviation|Mean
90958|NCT00899379|Secondary|Pain Relief at 2 Hours During the Fourth Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.||Participants|||Number
90959|NCT00899379|Secondary|Pain Relief at 2 Hours During the Third Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.||Participants|||Number
90960|NCT00899379|Secondary|Pain Relief at 2 Hours During the Second Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.||Participants|||Number
90961|NCT00899379|Primary|Pain Relief at 2 Hours During the First Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack|2 hours|The primary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase.||participants|||Number
90962|NCT00899353|Primary|The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.|"Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC.~Patients with MGUS or SMM were not enrolled into this study."|Baseline, month 1, month 2, month 3, month 6, month 9, 12 months|Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.||Fold Change|||Number
90963|NCT00899353|Primary|Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.|Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer’s protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.|baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)|NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (> median, n=7) and low initial baseline (< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods||10^6 NFkB Luminescence units/µg protein||Standard Error|Mean
90964|NCT00898807|Secondary|Neuropsychiatric Inventory (NPI)-- Agitation Subscore|NPI agitation score is based on responses from an informed caregiver involved in the patient's life. Symptom severity (1=mild, 2=moderate, 3=severe) is multiplied by frequency (1=occasionally, less than once/week; 4 = very frequently, once or more/day or continuously) to obtain the NPI agitation score.Range is 0-12. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."||units on a scale||Standard Deviation|Mean
90965|NCT00898807|Secondary|Cohen-Mansfield Agitation Inventory (CMAI)|CMAI examines several agitated behaviors including verbal, physical agitation, and other behaviors. Sub-items are summed. Range is 14-70. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."||units on a scale||Standard Deviation|Mean
90979|NCT00897949|Secondary|Pain Relief 2 Hours After Treatment for Headache Recurrence|Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).|2 hours after treatment for recurrence|Patients with initial headache recurrence who took rizatriptan 5 mg or 10 mg were prerandomized (ratio=1:1) to either rizatriptan 5 mg or 10 mg, respectively, or to placebo (ratio=1:1); and who took placebo, to either 5 mg or 10 mg of rizatriptan (ratio=1:1). Only those who took rizatriptan for their initial headache were considered for analysis.||Participants|||Number
90966|NCT00898807|Primary|Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)|Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in agitation(CGIC) accesses clinically significant change in agitation. A trained clinician, blind to treatment assignment, uses a 7-point Likert scale to rate change of each patient along a continuum from “marked improvement”(1), “no change”(4), and “marked worsening”(7). A number of aspects of the agitation is considered such as emotional agitation, mood liability/distress, psychomotor agitation, verbal aggression, and physical aggression. Range is 1-7.|Baseline to 9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on CGIC."||percentage moderate/marked improvement|||Number
90967|NCT00898807|Primary|NeuroBehavior Rating Scale-- Agitation|NeuroBehavioral Rating Scale- Agitation(NBRS-A) assesses multiple types of psychopathology common in dementia and is based on a seven point Likert scale of increasing severity for each item(i.e., 0=not present, 1=very mild, 2-mild, 3=moderate, 4=moderately severe, 5=severe, 6=extremely severe). The NBRS agitation subscore includes NBRS 'inhibition’, ‘agitation’, and ‘hostility’. The range is 0 to 18 points. Higher scores indicate more symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on the NBRS."||units on a scale||Standard Error|Mean
90968|NCT00898677|Secondary|Nausea at 2 Hours After Dose|Patients who recorded the presence or absence of nausea 2 hours after dose|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||participants|||Number
90969|NCT00898677|Secondary|Functional Status at 2 Hours After Dose|Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
90970|NCT00898677|Secondary|Pain Free at 2 Hours After Dose|Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.||Participants|||Number
90971|NCT00898677|Primary|Time to Relief Within 2 Hours After Dose|Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose|within 2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication.||Participants|||Number
90972|NCT00898677|Primary|Pain Relief at 2 Hours After Dose|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.||Participants|||Number
90973|NCT00898560|Secondary|AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day|||ng.h/mL||Standard Deviation|Mean
90974|NCT00898560|Secondary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day|||ng.h/mL||Standard Deviation|Mean
90975|NCT00898560|Primary|Cmax - Maximum Observed Plasma Concentration|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day|||pg/mL||Standard Deviation|Mean
90976|NCT00898443|Secondary|Impact of Anesthesia Type on OR (Operating Room) Efficiency|The time minutes)from initiation of anesthesia to surgery start.|minutes until surgery start|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.||minutes||Full Range|Median
90977|NCT00898443|Primary|Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation|Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.)|at the time of surgery|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.||participants|||Number
90978|NCT00898222|Primary|Change in Exhaled Inflammatory Mediator Levels|Descriptive statistics|baseline and 6 months|||pg/mL||Full Range|Mean
90980|NCT00897949|Secondary|Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug||2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
92849|NCT00878722|Secondary|Belinostat AUC (Area Under Curve)||Cycle 1, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d||ng*hrs/mL||Standard Deviation|Mean
90981|NCT00897949|Secondary|No Disability at 2 Hours After the Initial Dose of Test Drug|Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 – Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of functional disability within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
90982|NCT00897949|Secondary|Pain Free at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
90983|NCT00897949|Primary|Pain Relief at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|The primary analysis employed an “all-patients-treated” approach that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
90984|NCT00897910|Secondary|Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.||||||
90985|NCT00897910|Primary|Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.||||||
90986|NCT00897897|Secondary|Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire.|"Mean absolute change in the Symptom Severity Score (SSS) of the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) questionnaire after fibroid treatment with HIFU.~The SSS is a scale from 0-100, where 0 corresponds to no symptoms and 100 corresponds to the most severe symptoms."|At baseline and at 30 days following treatment|||scores on a scale||Standard Deviation|Mean
90987|NCT00897897|Primary|Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.|30 days after treatment|||Adverse Event/subject||Standard Deviation|Mean
90988|NCT00897715|Secondary|Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks|IL-6 is a sensitive laboratory assay for serum levels of Interleukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville||pg/ml||Inter-Quartile Range|Median
90989|NCT00897715|Primary|Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks|hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville.||mg/dl||Inter-Quartile Range|Median
90990|NCT00897390|Secondary|Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities|12-lead Electrocardiogram (ECG), Vital Sign (body temperature, respiratory rate, seated blood pressure and heart rate), and Physical Finding Abnormalities reported by investigator as AEs.|At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.||participants|||Number
90991|NCT00897390|Secondary|Number of Participants With Marked Urinalysis Abnormalities|Protein, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Glucose, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Blood, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). White Blood Cell (WBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). Red Blood Cell (RBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). (The '+' is a normal lab result and refers to the magnitude of the finding.)|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Number of Participants Analyzed=treated participants; n=number of participants evaluated for this measure (among the 6 participants who had the urinary WBC and RBC test, there are only 2 had a pre-study evaluation, and were therefore evaluable for these measures.||participants|||Number
90992|NCT00897390|Secondary|Number of Participants With Marked Laboratory Abnormalities (MA)|Laboratory abnormalities=any result that is clinically significant, met the definition of an SAE, required discontinuation or interruption of study drug, or required specific corrective therapy. Upper normal (UN)/lower normal (LN) values: leukocytes UN, 11.40x10^3 c/uL; absolute neutrophils/bands LN, 1.500x10^3 c/uL; aspartate aminotransferase UN, 48 U/L; alanine aminotransferase UN, 67 U/L; blood urea nitrogen UN, 20.0 mg/dL; creatine kinase UN, 350 U/L; lactate dehydrogenase UN, 249 U/L.|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.||participants|||Number
91010|NCT00897104|Secondary|Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])|Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence|24 hours|The duration of relief, or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1), was calculated for responders who had a headache recurrence.||Hours||Standard Deviation|Mean
90993|NCT00897390|Secondary|AEs of Special Interest|See Outcome Measure 16 for a definition of AEs. AEs of clinical interest for saxagliptin were defined as those relating to the following:skin disorders, infection-related AEs (system organ class [SOC]: Infections and Infestations), thrombocytopenia, lymphopenia, hypoglycemia, cardiovascular AEs indicative of acute cardiovascular events, localized edema, fractures, pancreatitis, and AEs of hypersensitivity.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).|All treated participants||participants|||Number
90994|NCT00897390|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject’s participation in the study.|All treated participants||participants|||Number
90995|NCT00897390|Secondary|BMS-510849 PK Parameter T-Max|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Full Range|Median
90996|NCT00897390|Secondary|BMS-510849 PK Parameter T-Half|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from their respective plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Standard Deviation|Mean
90997|NCT00897390|Secondary|BMS-510849 PK Parameter Cmax|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng/mL||Full Range|Geometric Mean
90998|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(0-T)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
90999|NCT00897390|Primary|Metformin PK Parameter Tmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Full Range|Median
91000|NCT00897390|Primary|Metformin PK Parameter T-HALF|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Standard Deviation|Mean
91001|NCT00897390|Primary|Metformin PK Parameter Cmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng/mL||Full Range|Geometric Mean
91002|NCT00897390|Primary|Metformin PK Parameter AUC(0-T)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
91003|NCT00897390|Primary|Metformin PK Parameter AUC(INF)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
91004|NCT00897390|Primary|Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Full Range|Median
91005|NCT00897390|Primary|Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||hours||Standard Deviation|Mean
91006|NCT00897390|Primary|Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng/mL||Full Range|Geometric Mean
91007|NCT00897390|Primary|Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
91008|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(INF)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
91009|NCT00897390|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures||ng*h/mL||Full Range|Geometric Mean
91397|NCT00892957|Primary|Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|4 minutes post start of treatment application|Intent to Treat||Percentage of participants||95% Confidence Interval|Number
91012|NCT00897104|Secondary|Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment|Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.|2 hours after treatment|“All-participants-treated” approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories.||Participants|||Number
91013|NCT00897104|Secondary|Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities|Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
91014|NCT00897104|Secondary|Pain Free at 2 Hours After Treatment|Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
91015|NCT00897104|Primary|Time to Relief Within 2 Hours After Treatment|Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).|within 2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication.||Participants|||Number
91016|NCT00897104|Primary|Pain Relief at 2 Hours After Treatment|Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value.||Participants|||Number
91017|NCT00896779|Primary|Mean Change in Visual Acuity|Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported.|12 months|||letters||Standard Deviation|Mean
91018|NCT00896649|Secondary|Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study|Number of participants satisfied with PEM with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied.|One month|All participants who completed imaging and questionnaires.||participants|||Number
91019|NCT00896649|Primary|"Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Call-back in Mammography vs BI-RAD 0 in PEM"|"Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Mammogram compared to number of patients with BI-RAD 0 in PEM~Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale:~0 = Inconclusive for malignancy; call-back in mammography~= normal~= abnormal, with no malignancy~= abnormal, likely benign~= abnormal, likely malignant~= malignant"|immediately at completion of mammogram|Number of participants who completed protocol with complete data set||participants|||Number
91020|NCT00896454|Secondary|Change From Baseline in Corrected Serum Calcium||Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Efficacy Analysis Subset included all participants who received at least 1 dose of denosumab. n = Number of participants who had non-missing data at Baseline and the time point of interest.||mmol/L||Inter-Quartile Range|Median
91021|NCT00896454|Secondary|Time to Relapse/Nonresponse of Hypercalcemia of Malignancy|Time to relapse/nonresponse was defined as the number of days from study Day 1 until the last day of CSC ≤ 11.5 mg/dL for all particiipants with relapse after the first response. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after first response. For participants who never achieved response, time to relapse/nonresponse was set to zero. Otherwise, if there was no post-baseline CSC assessment, time to relapse/nonresponse was censored on study Day 1. Time to relapse/nonresponse was estimated using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset||days||95% Confidence Interval|Median
91022|NCT00896454|Secondary|Duration of Complete Response|Duration of complete response is defined as the number of days from the first day of of corrected serum calcium ≤ 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium ≤ 10.8 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 10.8 mg/dL after the complete response. If a participant had no CSC assessment after the complete response, duration of complete response was set to zero and censored. Duration of complete response was summarized for participants who achieved a complete response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a complete response in the Response Analysis Subset||days||95% Confidence Interval|Median
91023|NCT00896454|Secondary|Duration of Response|Duration of response is defined as the number of days from the first day of corrected serum calcium ≤ 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after the first response. If a participant had no CSC assessment after the first response, duration of response was set to zero and censored. Duration of response was summarized for participants who achieved a response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a response in the Response Analysis Subset||days||95% Confidence Interval|Median
92899|NCT00877929|Secondary|SBP Control 130 at Four Weeks|Mean seated SBP < 130 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
91024|NCT00896454|Secondary|Time to Complete Response|Time to complete response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) was ≤ 10.8 mg/dL (2.7 mmol/L). Participants were censored on the last CSC assessment day if no complete response was observed. If there was no post-baseline CSC assessment, time to complete response was censored on study Day 1. Time to complete response was analyzed using Kaplan–Meier methods.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset||days||95% Confidence Interval|Median
91025|NCT00896454|Secondary|Time to Response|"Time to Response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if no response was observed. If there was no post-baseline CSC assessment, time to response was censored on study Day 1.~Time to response was analyzed using Kaplan–Meier methods."|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset||days||95% Confidence Interval|Median
91026|NCT00896454|Secondary|Percentage of Participants With a Complete Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 10.8 mg/dL (2.7 mmol/L). For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL])).|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset||percentage of participants||95% Confidence Interval|Number
91027|NCT00896454|Secondary|Percentage of Participants With a Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset||percentage of participants||95% Confidence Interval|Number
91028|NCT00896454|Primary|Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))|10 days|Response Analysis Subset including all participants who received at least 1 dose of denosumab and had a screening CSC (from local lab) > 12.5 mg/dL (3.1 mmol/L).||percentage of participants||95% Confidence Interval|Number
91029|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.||units on a scale||Standard Deviation|Mean
91030|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.||units on a scale||Standard Deviation|Mean
91031|NCT00896337|Secondary|Walking Impairment Questionnaire Score-Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.||units on a scale||Standard Deviation|Mean
91032|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.||units on a scale||Standard Deviation|Mean
91033|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.||units on a scale||Standard Deviation|Mean
91034|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.||units on a scale||Standard Deviation|Mean
91035|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.||units on a scale||Standard Deviation|Mean
92900|NCT00877929|Secondary|SBP Control 130 at Six Weeks|Mean seated SBP < 130 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
91036|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.||units on a scale||Standard Deviation|Mean
91037|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.||units on a scale||Standard Deviation|Mean
91038|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.||percentage of lesions|Participants||Number
91039|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.||percentage of lesions|Participants||Number
91040|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable||percentage of lesions|Participants||Number
91041|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable||percentage of lesions|Participants||Number
91042|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.||percentage of lesions|Participants||Number
91043|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.||percentage of lesions|Participants||Number
91044|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable||percentage of lesions|Participants||Number
91045|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable||percentage of lesions|Participants||Number
91046|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.||ratio|Participants|Standard Deviation|Mean
92901|NCT00877929|Secondary|SBP Control 130 at Eight Weeks|Mean seated SBP < 130 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
91047|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.||ratio|Participants|Standard Deviation|Mean
91048|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||ratio|Participants|Standard Deviation|Mean
91049|NCT00896337|Secondary|Ankle-Brachial Index|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Hospital Discharge (1-2 days post-procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||ratio|Participants|Standard Deviation|Mean
91050|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||ratio|Participants|Standard Deviation|Mean
91051|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.||percentage of lesions|Participants||Number
91052|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.||percentage of lesions|Participants||Number
91053|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.||percentage of lesions|Participants||Number
91054|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of lesions|Participants||Number
91055|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of lesions|Participants||Number
91056|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Very late stent thrombosis is defined as >365 days following the trial procedure."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable||percentage of participants|||Number
91247|NCT00894803|Other Pre-specified|Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 7 days of treatment onset|||participants|||Number
91057|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Very late stent thrombosis is defined as >365 days following the trial procedure."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable||percentage of participants|||Number
91058|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable||percentage of participants|||Number
91059|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable||percentage of participants|||Number
91060|NCT00896337|Secondary|Sub-acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure."|>24 Hours to <=30 Days Post-index procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable||percentage of participants|||Number
91061|NCT00896337|Secondary|Acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure."|24 Hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of participants|||Number
91062|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.||percentage of participants|||Number
91063|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.||percentage of participants|||Number
91064|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of participants|||Number
91065|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Post-procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of participants|||Number
91066|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of participants|||Number
91067|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.||percentage of limbs|Participants||Number
91068|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.||percentage of limbs|Participants||Number
91069|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of limbs|Participants||Number
91070|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.||percentage of limbs|Participants||Number
91071|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.||percentage of patients|||Number
91072|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.||percentage of patients|||Number
91073|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable||percentage of participants|||Number
91074|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable||percentage of participants|||Number
91075|NCT00896337|Secondary|Procedure Success|Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).|In hospital (1-2 days post procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of participants|||Number
91076|NCT00896337|Secondary|Technical Success|Residual lesion stenosis <=30% based on visual assessment immediately postprocedure|Index procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of lesions|Participants||Number
91077|NCT00896337|Secondary|Myocardial Infarction (MI)|Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.|Index hospitalization|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint||percentage of participants|||Number
91078|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.||percentage of participants|||Number
91079|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.||percentage of participants|||Number
91080|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.||percentage of participants|||Number
91137|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91081|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
91082|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of participants|||Number
91083|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.||percentage of participants|||Number
91084|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.||percentage of participants|||Number
91085|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.||percentage of participants|||Number
91086|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
91087|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.||percentage of participants|||Number
91088|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.||percentage of participants|||Number
91089|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.||percentage of participants|||Number
91090|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
91091|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.||percentage of participants|||Number
91092|NCT00896337|Primary|Device- and/or Procedure-related Major Adverse Events (MAE)|MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.||percentage of participants|||Number
91155|NCT00895895|Secondary|Percentage of Participants Who Were Responders at Week 24|Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.|Week 24|ITT; N=number of participants with evaluable data||percentage of participants|||Number
91093|NCT00896233|Primary|Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.||percent treatment difference||95% Confidence Interval|Number
91094|NCT00896233|Primary|Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.||percent treatment difference||95% Confidence Interval|Number
91095|NCT00896233|Primary|Repeated Mean Liver Elastic Stiffness (kPa) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.||kPa||Standard Deviation|Mean
91096|NCT00896233|Primary|Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.||kPa||Standard Deviation|Mean
91097|NCT00896168|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26|ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Millimeter/1 hour||Standard Deviation|Mean
91098|NCT00896168|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 26|CRP is a protein found in the blood, the levels of which rise in response to inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. Here, 'N' signifies participants who were evaluated for this outcome measure.||Milligram/Liter||Standard Deviation|Mean
91099|NCT00896168|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Units on a scale||Standard Deviation|Mean
91100|NCT00896168|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 26|Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Minutes||Standard Deviation|Mean
91101|NCT00896168|Secondary|Change From Baseline in Physicians' Global Disease Assessment at Week 26|Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using “0=no active RA” to “100=most serious active RA” scale.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.||Units on a scale||Standard Deviation|Mean
91102|NCT00896168|Secondary|Change From Baseline in Participants' Global Disease Assessment at Week 26|"Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using “0 mm=very good” to “100 mm=very poor scale."|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Units on a scale||Standard Deviation|Mean
91103|NCT00896168|Secondary|Change From Baseline in Participant’s Pain Visual Analogue Scale (VAS) Score at Week 26|Participant’s pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Units on a scale||Standard Deviation|Mean
91104|NCT00896168|Secondary|Change From Baseline in Tender Joints Count at Week 26|Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Tender joints||Standard Deviation|Mean
91177|NCT00895843|Secondary|Mean Pain Intensity|Mean VAS scores of pain intensity for each time points|30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery||||||
91178|NCT00895843|Primary|Number of Patients Needing Rescue Medication|Number of patients who required rescue medication within 6 hours|At 6 hours|||Participants|||Number
91179|NCT00895830|Primary|Experienced Post-operative Nausea or Vomiting||24 hours|ITT||participants|||Number
91105|NCT00896168|Secondary|Change From Baseline in Swollen Joints Count at Week 26|Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Swollen joints||Standard Deviation|Mean
91106|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response|ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Percentage of participants|||Number
91107|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response|ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.||Percentage of participants|||Number
91108|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response|ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|Full analysis set (FAS) included participants who received at least 1 dose of study medication and had post efficacy data.||Percentage of participants|||Number
91109|NCT00896051|Secondary|Time to Virologic Failure|The table below shows the number of days to virologic failure defined as a plasma viral load (VL) > 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL <50, and <400 copies/mL according to the time to loss of virologic response [TLOVR] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Days||95% Confidence Interval|Median
91110|NCT00896051|Secondary|Time to Confirmed Virologic Response|The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) <50 copies/mL, and plasma VL <400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Days||95% Confidence Interval|Median
91111|NCT00896051|Secondary|Change From Pre-Baseline in Log10 Viral Load Over Time|The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method.|Pre-Baseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||log10 (Copies/mL)||Standard Error|Mean
91112|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method|The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (<50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48.|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Participants|||Number
91113|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method|The table below shows the percentage of participants with a virologic response defined as a viral load <50 Copies/mL and <400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method.|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Particpants|||Number
91114|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method|The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) <50 copies/mL, and with plasma VL <400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change).|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Participants|||Number
91115|NCT00896051|Secondary|Change From Prebaseline in CD4+ Cell Count Over Time|The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method.|Prebaseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||CD4+ cell count||Standard Error|Mean
91116|NCT00896051|Primary|Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48|The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change).|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||Percentage of Participants||95% Confidence Interval|Number
91117|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/mL||Standard Deviation|Mean
91118|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng/ml||Standard Deviation|Mean
91119|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/ml||Standard Deviation|Mean
91120|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng/ml||Standard Deviation|Mean
91121|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/ml||Standard Deviation|Mean
91122|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng/ml||Standard Deviation|Mean
91123|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.||ng.h/mL||Standard Deviation|Mean
91124|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).||ng/ml||Standard Deviation|Mean
91125|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.||ng.h/mL||Standard Deviation|Mean
91126|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.||ng/ml||Standard Deviation|Mean
91127|NCT00896038|Primary|PTSD Total Symptom Severity Score|PTSD total symptom severity was measured using the Clinician-Administered PTSD Scale (CAPS). This is a 30-item interview-based questionnaire that measures symptom severity during the past week. The total symptom severity score ranges from 0 (lowest symptom severity) to 136 (highest symptom severity).|Day 29 of the treatment period, 2 days after the final script presentation|The analysis included subjects who completed the CAPS at both baseline (Day 1) and Day 29, and who had data for the baseline covariates used in the analysis||units on a scale||Standard Error|Mean
91128|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91129|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91130|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91131|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91132|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91133|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91134|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91135|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91136|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91180|NCT00895817|Secondary|Endoscopic Change|Following therapy, resolution of EE findings will be assessed.|8 weeks||||||
91181|NCT00895817|Secondary|Symptom Score|Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.|8 weeks||||||
92902|NCT00877929|Secondary|SBP Control 140 at One Week|Mean seated SBP < 140 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
91138|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91139|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91140|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91141|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91142|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91143|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)||units on a scale||Standard Error|Mean
91144|NCT00896025|Secondary|To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation).||3 Weeks, 1-year and 2-year follow-ups||||||
91145|NCT00896025|Primary|The Primary Outcome is to Compare All Patients Who Survive (With or Without Transplant) to Those Who Die.||3 Weeks, 1-year and 2-year follow-ups|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Zero participants were analyzed because the small sample size would not yield meaningful results|||||
91146|NCT00895947|Post-Hoc|Acute Respiratory Illness|"Number of subjects in each group meeting definition of acute respiratory illness (ARI), defined as 2 or more cold/flu symptoms reported in the same week. Further defined as febrile or afebrile depending on whether the subject reported the symptom of feverishness."|16 weeks|||participants|||Number
91147|NCT00895947|Secondary|Incidence/Severity of Viral Respiratory Infections|Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection|16 weeks|||participants|||Number
91148|NCT00895947|Secondary|Negative Events Related to Cold/Flu Symptoms|Number of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity|16 weeks|||participants|||Number
91149|NCT00895947|Secondary|Impact of Cold/Flu Symptoms|Number of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.|16 weeks|||participants|||Number
91150|NCT00895947|Secondary|Symptom Incidence/Severity|Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly|16 weeks|||participants|||Number
91151|NCT00895947|Primary|Frequency of Influenza-like Illness|Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).|16 weeks|Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug||participants|||Number
91152|NCT00895934|Secondary|Relapse-free Survival (RFS)|Estimated using Kaplan-Meier method. Logistic regression will be used as a tool to assess the association of various factors with the probability of response, recognizing that the power to detect statistically significant associations will be limited due to the sample size (and expected number of responses). The impact of remission and post-remission therapy on RFS will be assessed using Cox regression with remission and therapy treated as time-dependent covariates.|Up to 3 years||||||
91153|NCT00895934|Primary|Efficacy Defined as Best Response Achieved During Study Treatment Measured by Complete Remission (CR) Rate||Up to 3 years|||participants|||Number
91154|NCT00895934|Primary|Dose-limiting Toxicity and Maximum Tolerated Dose of Vorinostat (Phase I)||42 days||||||
91156|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
91157|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Movement Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
91158|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
91159|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
91160|NCT00895895|Secondary|Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||correct trials||Standard Deviation|Mean
91161|NCT00895895|Secondary|Change From Baseline in CANTAB PRM-Percentage Correct at Week 24|CANTAB-PRM assessed participant’s visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||percentage of correct answers||Standard Deviation|Mean
91162|NCT00895895|Secondary|Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24|CANTAB-PRM assessed participant’s visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||msec||Standard Deviation|Mean
91163|NCT00895895|Secondary|Change From Baseline in CANTAB SWM Strategy at Week 24|CANTAB-SWM assessed participant’s ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||boxes||Standard Deviation|Mean
91164|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
91165|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
91166|NCT00895895|Secondary|Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
91167|NCT00895895|Secondary|Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
91168|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||correct choices||Standard Deviation|Mean
91169|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||patterns||Standard Deviation|Mean
91170|NCT00895895|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data||errors||Standard Deviation|Mean
91171|NCT00895895|Secondary|Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24|Caregiver and participant interview-based tool to rate the overall impression of participant’s clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.|Baseline, Week 24|ITT; N=number of evaluable participants||participants|||Number
91172|NCT00895895|Secondary|Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24|Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances|Baseline, Week 24|ITT; N=number of participants with evaluable data||unit on a scale||Standard Deviation|Mean
91173|NCT00895895|Secondary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24|Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant’s actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of “Not Applicable” was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.|Baseline, Week 24|ITT; N=number of participants with evaluable data||percentage of yes answers||Standard Deviation|Mean
91174|NCT00895895|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24|14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.|Baseline, Week 24|Intent to treat (ITT) population: randomized participants who took at least one dose of study medication, had a baseline evaluation and had at least one on-treatment post-baseline evaluation for the ADAS-Cog; Number of Participants Analyzed (N): number of evaluable participants||units on a scale||Standard Deviation|Mean
91175|NCT00895843|Secondary|Pain Control/Relief|Patient satisfaction scores|48 hours after surgery (end of study)||||||
91176|NCT00895843|Secondary|Time to Rescue|Time taken for rescue medication requirement|Between 30mins and 48 hours||||||
91182|NCT00895817|Primary|Number of Participants Who Responded|Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.|8 weeks|Sample size estimation was based on the assumptions:10% of the EE patients will respond to PPI compared to 55% of patients treated with steroids. Controlling the probability of a Type I error at alpha=0.05, a sample of 38 patients in the treatment groups (19 in each arm) will have 80% power to detect a difference in treatment response of 45%.||participants|||Number
91183|NCT00895583|Secondary|Percentage of Participants With Malignancy|Includes any adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
91184|NCT00895583|Secondary|Percentage of Participants With Polyomavirus Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'polyomavirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
91185|NCT00895583|Secondary|Percentage of Participants With Cytomegalovirus (CMV) Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'cytomegalovirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
91186|NCT00895583|Secondary|Percentage of Participants With Infection|Includes adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
91187|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes Receiving Treatment for Diabetes (Insulin and Non-Insulin)|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged between baseline and Month 12 or Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose ≥126 mg/dL after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization.|12 Months and 24 Months|Safety Population. Only participants with new-onset diabetes mellitus at the beginning of the analysis interval were included; those with pre-existing diabetes were excluded from the analysis.||percentage of participants|||Number
91188|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged from baseline to Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose greater than or equal to (≥)126 milligrams per deciliter (mg/dL) after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization, were included in the new-onset diabetes population. Events at Months 12 or 24 occurred from baseline to On-therapy Month 12 and from On-therapy Months 12 to 24, respectively.|From Baseline to On-Therapy Month 12, from Baseline to On-Therapy Month 24, and from On-Therapy Month 12 up to On-Therapy Month 24|Safety Population; participants at risk of new-onset diabetes mellitus at the beginning of the analysis interval were included and those with pre-existing diabetes were excluded from the analysis. n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
91189|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Body Mass Index (BMI; in Kilograms Per Square Meter [kg/m^2])|BMI = Weight (kg)/(Height*Height) (square meters [m^2]).|Baseline, Month 12|Safety Population||kg/m^2||Standard Error|Mean
91190|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in HOMA-Beta Cell (HOMA-B; Fasting)|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA-B = 20 * insulin (µU/L) / fasting plasma glucose (mmol/L) minus (-) 3.5 Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population||percentage beta cell function||Standard Error|Mean
91191|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Homeostasis Model Assessment Insulin Resistance (HOMA-IR; Fasting)|"The HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements:~HOMA-IR = fasting plasma glucose (mmol/L) multiplied by (*) fasting plasma insulin in microunits per liter (µU/L) divided by (/) 22.5.~Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population||insulin resistance score||Standard Error|Mean
91192|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Waist Circumference(Centimeters [cm])||Baseline, Month 12|Safety Population||cm||Standard Error|Mean
91193|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Weight (Kilograms [kg])||Baseline, Month 12|Safety Population||kg||Standard Error|Mean
91194|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Insulin (Picomoles Per Liter [Pmol/L])||Baseline, Month 12|Safety Population||pmol/L||Standard Error|Mean
91195|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Glucose (mmol/L)||Baseline, Month 12|Safety Population||mmol||Standard Error|Mean
91196|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Hemoglobin A1C (Liter Per Liter [L/L])|Ratio of hemoglobin A1c to normal hemoglobin.|Baseline, Month 12|Safety Population||L/L||Standard Error|Mean
91197|NCT00895583|Secondary|Percentage of Participants Requiring Treatment for Stomatitis by Treatment Type|Included treatments (analgesics, dental paste, topical antifungal, topical steroids, or other) prior to randomization, during the on-therapy period (up to 19 to 21 months post-randomization) and the off-therapy period (up to 24 months post-transplantation).|On-Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population||percentage of participants|||Number
91198|NCT00895583|Secondary|Percentage of Participants With Stomatitis|Includes adverse events based on categorization by the investigator as stomatitis, regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA)|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population||percentage of participants|||Number
91248|NCT00894803|Other Pre-specified|Serious Systemic Bleeding|Incidence of serious systemic bleeding defined as requiring transfusion of 2 or more units of packed red blood cells.|Within 7 days of treatment onset|||participants|||Number
91199|NCT00895583|Secondary|Percentage of Participants With Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor Block (ARB) Use|Included ACEI or ARB use prior to randomization, during the on-therapy period (up to 19 to 21 months post randomization) and the off-therapy period (up to 24 months post-transplantation).|Pre-randomization, On-Therapy Period (up to 21 months post-randomization), and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population||percentage of participants|||Number
91200|NCT00895583|Secondary|Spot and 24 Hour Urine Protein to Creatinine Ratio (UPr/Cr)|Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline and Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||UPr/Cr||Standard Deviation|Mean
91201|NCT00895583|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication, Diabetes Agents, Lipid-Lowering Agents, or Erythropoiesis Stimuating Agents (ESAs)||Baseline, Months 12 and 24|ITT Population||percentage of participants|||Number
91202|NCT00895583|Secondary|Change From Baseline (Pre-Randomization) to 12 and 24 Months Post-Transplantation in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L])|Parameters assessed included total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C); collected when participant was in a fasting state.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||mmol/L||Standard Error|Mean
91203|NCT00895583|Secondary|Percentage of Participants With Anemia, Thrombocytopenia, or Leukopenia|Anemia was defined as hemoglobin less than or equal to (≤)10 grams per deciliter (g/dL); leukopenia was defined as white blood cell (WBC) count ≤2000 per cubic millimeters (/mm^3); and thrombocytopenia was defined as platelets ≤100,000/mm^3. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
91204|NCT00895583|Secondary|Percentage of Participants With Antibody Use in Treatment of Acute Rejection|Number of participants who experienced an adverse event (AE) of rejection was used as the denominator in the determination of percentage of participants with antibody use in treatment of acute rejection.|On Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|Safety Population; only participants with an AE of rejection were included in the analysis.||percentage of participants|||Number
91205|NCT00895583|Secondary|Number of Participants With BCAR by Severity of First BCAR and Time of Onset From Post-Randomization to 6, 12, 18, and 24 Months Post-Transplant|BCAR was categorized as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (moderate), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category.|Months 6, 12, 18, and 24|ITT Population||participants|||Number
91206|NCT00895583|Secondary|Percentage of Participants With First On-Therapy BCAR From Transplantation Occurring at 12 and 24 Months|Defined as the first BCAR occurring during the On-Therapy period based on the ITT population. Time to first BCAR was the days from transplantation to the date of BCAR.|Months 12 and 24|ITT Population||percentage of participants|||Number
91207|NCT00895583|Secondary|Percentage of Participants With BCAR Post-Randomization to 6, 12, 18, and 24 Months Post-Transplantation|BCAR was defined according to updated Banff criteria (2007) for renal allograft rejection.|Post-Randomization to 6, 12, 18, and 24 months Post-Transplantation|ITT Population||percentage of participants|||Number
91208|NCT00895583|Secondary|Percentage of Participants With Graft Loss (Including Death) at 12 and 24 Months Post-Randomization|Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for ≥56 days with no return of graft function), or death.|Post-randomization to Months 12 and 24 Post-Transplantation|ITT Population||percentage of participants|||Number
91209|NCT00895583|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection (BCAR), Graft Loss, or Death From Randomization to 24 Months Post-Transplantation|Biopsy-confirmed acute rejection was defined according to updated Banff criteria (2007) for renal allograft rejection. Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for greater than or equal to [≥]56 days with no return of graft function), or death.|Post-randomization to Month 24 post-transplantation|ITT Population||percentage of participants|||Number
91210|NCT00895583|Secondary|Change From Randomization in Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in mcmol/L. Baseline was defined as the last assessment prior to first administration of study drug.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.||mcmol/L||Standard Error|Mean
91211|NCT00895583|Secondary|Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in micromillimoles per liter (mcmol/L). Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.||mcmol/L||Standard Deviation|Mean
91212|NCT00895583|Secondary|Slope of Calculated GFR (MDRD) From Randomization to 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Timepoints were calculated as study days, relative to the time of randomization of study medication. All available on-therapy values were included. Observed data were multiplied by a scale factor of 365, expressing the slope as an annual change.|Baseline, Month 24|On-Therapy analysis of the slope comprised the data collected from the on-therapy evaluations for all the participants in the ITT population; data collected from participants receiving sirolimus during the first 3 weeks post-randomization for safety monitoring were excluded from the analysis.||mL/min/1.73 m^2 per year||95% Confidence Interval|Mean
91213|NCT00895583|Secondary|Change From Randomization in Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population; n=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Error|Mean
91214|NCT00895583|Secondary|Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. number (n)=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Deviation|Mean
91215|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥10 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.||percentage of participants|||Number
91216|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥7.5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.||percentage of participants|||Number
91217|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation (Intent-to-Treat [ITT] Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population: all randomized participants who received at least 1 dose of the assigned therapy after randomization. Missing GFR was imputed as follows: 1) GFR equals (=)0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.||percentage of participants|||Number
91218|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Month 12|On-Therapy Population (12 Months): all randomized participants who remained on assigned study therapy through 12 months post-transplantation.||percentage of participants|||Number
91219|NCT00895583|Primary|Percentage of Participants With Improvement of Greater Than or Equal to [≥]5 Milliliters Per Minute Per 1.73 Square Meters (mL/Min/m^2) in Calculated Glomerular Filtration Rate (GFR) at 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the Modified Diet in Renal Disease (MDRD) equation using either serum creatinine traceable to isotope dilution mass spectrometry (IDMS) or serum creatinine not traceable to IDMS.|Baseline, Month 24|On-Therapy Population (24 Months): all randomized participants who remained on assigned study therapy through 24 months post-transplantation.||percentage of participants|||Number
91220|NCT00895453|Primary|Candida Culture Free After Maintenance Therapy|candida culture free (monthly vaginal cultures were obtained)|12 months|||participants|||Number
91221|NCT00895310|Secondary|Duration of Stable Disease||From the start of treatment until disease progression|||Days||Full Range|Median
91222|NCT00895310|Secondary|Progression Free Survival|Response Evaluation Criteria In Solid Tumors (RECIST) radiographic criteria for progression|From start of study to disease progression|||Days||95% Confidence Interval|Median
91223|NCT00895310|Secondary|PSA Response (>30% From Baseline)||Every cycle (4 weeks)|||Participants|||Count of Participants
91224|NCT00895310|Primary|Prostate Specific Antigen (PSA) Response (>50% Reduction From Baseline)|Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a >=50% decrease in PSA.|Every Cycle (4 weeks)|||Participants|||Count of Participants
91225|NCT00895284|Primary|Total Procedure Time - Skin Incision to Skin Closure||At skin closure.|The study was terminated due to lack of funding; due to the small sample size, no analysis was done.|||||
91226|NCT00895232|Secondary|Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)|Quantifies amount of leg movement|Baseline to Day 84|Only subjects who recorded PLM's/Hour at Baseline AND on Day 84.||PLM's per hour||Standard Deviation|Mean
91227|NCT00895232|Post-Hoc|Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.|Response is defined as any effect based on a scale of 0 through 4 where 0 = no effect, 1 = mild effect, 2 = moderate effect, 3 = marked effect, and 4 = dramatic effect.|Baseline to Day 84|Only subjects who were evaluated at Baseline AND on Day 84||percent of participants|||Number
91228|NCT00895232|Primary|Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale|Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])|Baseline to Day 84|Only subjects who completed the IRLSSG Rating Scale at baseline AND on Day 84.||units on a scale||Standard Deviation|Mean
91229|NCT00895193|Primary|Maximum Flushing Severity Score|Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.||units on a scale||Standard Deviation|Mean
91230|NCT00895193|Primary|Duration of Flushing|The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.||minutes||Standard Deviation|Mean
91231|NCT00895193|Primary|Time to Flushing|The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.||minutes||Standard Deviation|Mean
91469|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2|||participants|||Number
91232|NCT00895193|Primary|Incidence of Flushing|Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.|Hourly for 6 hours on day of dosing|This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study.||participants|||Number
91233|NCT00895011|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 & 15 range from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.||scores on a scale||Standard Error|Least Squares Mean
91234|NCT00895011|Primary|The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.||Percentage of Sexual Attempts||Standard Deviation|Least Squares Mean
91235|NCT00895011|Primary|Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
91236|NCT00894803|Post-Hoc|Modified Rankin Scale (mRS) of 0-1|"Modified Rankin Scale of 0 or 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of ‘6’, and assigned the “bad” outcome. Also those lost to follow-up were assigned the “bad” outcome.~The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset|||participants|||Number
91237|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤2 at 90 Days|"Study subjects with an NIH stroke scale score ≤ 2 points at 90 days from treatment onset compared to baseline value, those dead or unable to be evaluated by the NIHSS were assigned the “bad” outcome.~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|90 days from treatment onset|||participants|||Number
91238|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 2|"Study subjects with an NIH stroke scale score of ≤ 2 at 24 hours from treatment onset, those dead (n=1) or sedated and unable to be evaluated by the NIHSS were assigned the “bad” outcome (n=5).~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 24 hours of treatment onset|||participants|||Number
91239|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 5|"Study subjects with an NIH stroke scale score of ≤ 5 at 2 hours from treatment onset, those sedated and unable to be evaluated by the NIHSS were assigned the “bad” outcome (n=1).~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 2 hours of treatment onset|||participants|||Number
91240|NCT00894803|Secondary|Glasgow Outcome Scale (GOS) of 1|"Glasgow outcome scale score of 1 versus greater than 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the “bad” outcome.~The Glasgow Outcome Scale is scored; 1=good recovery, 2=moderately disabled, 3=severely disabled, 4=vegetative survival, 5=dead."|90 days from treatment onset|||participants|||Number
91241|NCT00894803|Secondary|Barthel Index ≥ 95|"Barthel index score of ≥ 95. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the “bad” outcome.~The Barthel index is a score comprised of 10 individual items. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The individual items are summed to produce a total score between 0 and 100; where 0 is inferior performance and 100 is optimal. A score of ≥ 95 is usually considered excellent."|90 days from treatment onset|||participants|||Number
91242|NCT00894803|Post-Hoc|Death Due to Stroke Within 90 Days of Treatment Onset|Death due to stroke within 90 days of treatment onset. Classified by blinded clinical investigators|Within 90 days of treatment onset|||participants|||Number
91243|NCT00894803|Post-Hoc|Death Within 90 Days of Treatment Onset|Death due to any cause within 90 days of treatment onset|Within 90 days of treatment onset|||participants|||Number
91244|NCT00894803|Other Pre-specified|Death Due to Stroke Within 7 Days of Treatment Onset|Death due to stroke within 7 days of treatment onset. Classified by blinded clinical investigators|Within 7 days of treatment onset|||participants|||Number
91245|NCT00894803|Other Pre-specified|Death Within 7 Days of Treatment Onset|Death due to any cause within 7 days of treatment onset|Within 7 days of treatment onset|||participants|||Number
91246|NCT00894803|Other Pre-specified|Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset|Any ICH observed on CT by the study site neuroradiologist and the independent study neuroradiologist; the central reader. The ICH would not be related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH,where judgment of significant neurological decline was made by the local clinical investigator. A third independent reader will make the final determination if there is disagreement between the treating investigator and the central reader|Within 7 days of treatment onset|||participants|||Number
91470|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1|||participants|||Number
91249|NCT00894803|Primary|Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline|"Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of ‘6’, and assigned the “bad” outcome. Also those lost to follow-up were assigned the “bad” outcome.~The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset|||participants|||Number
91250|NCT00894803|Primary|Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset|Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 36 hours of initiation of therapy|||participants|||Number
91251|NCT00894790|Secondary|Change From Baseline in Participant's Responses to Neck Disability Index (NDI)|NDI: participant-administered 10-item questionnaire to assess how neck pain affects 10 activities of daily living (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) with six potential responses, each describing a greater degree of disability (0 = no disability to 5 = total disability). Total score calculated by adding individual item scores for evaluation scheme: 0-5 = No disability; 6-15 = Mild disability; 16-25 = Moderate disability; 26-35 = Severe disability; Above 35 = Complete disability.|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
91252|NCT00894790|Secondary|Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire|Two part questionnaire; First part assessed symptoms: feeling of gas/air in stomach or feeling bloated, nausea, vomiting, excessive burping or belching and worsening of heartburn or acid reflux. Participant rated Yes/No experienced, for how many days per week (1 through 7) for each symptom and how bothered they were (not at all, somewhat or very). Second part assessed the presence of general abdominal pain (steady, dull, sharp/shooting, always present or comes and goes), the number of days they experienced it (1 through 7) and how bothered they were by it (not at all, somewhat, very).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
91253|NCT00894790|Secondary|Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
91254|NCT00894790|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours.|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
91255|NCT00894790|Secondary|Change From Baseline on Physician’s Global Assessment of Cervical Injury|Physician rated responses evaluating the overall condition of participant's cervical injury at that time. Response option ranged from 1 (Very mild - Very mild signs and symptoms of cervical injury) to 5 (Very Severe - Very severe signs and symptoms of cervical injury).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
91256|NCT00894790|Secondary|Change From Baseline in Patient Global Assessment of Cervical Injury|Participant rated responses to question: Considering all the ways your cervical injury affects you, how are you doing today? Response options ranged from 1 (Very good - No symptoms and no limitation of normal activities) to 5 (Very Poor - Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Days 7, 14|Data not analyzed due to study termination.||units on a scale||Standard Deviation|Mean
91257|NCT00894790|Secondary|Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain) with at least a 20 mm improvement.|Baseline, Days 7, 14|Data not analyzed due to study termination.||Percentage of participants|||Number
91258|NCT00894790|Secondary|Change From Baseline on VAS-pain at Day 3 and Day 14|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Days 3, 14|Data not analyzed due to study termination.||mm||Standard Deviation|Mean
91259|NCT00894790|Primary|Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Day 7|Data not analyzed due to study termination.||mm||Standard Deviation|Mean
91260|NCT00894699|Primary|Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4)|The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.|4 hour study period|ITT population were those patients that took at least one dose of study medication.||units on a scale||Standard Error|Least Squares Mean
91261|NCT00894647|Secondary|Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)|"LSRs were assessed independently from AEs. The frequency and percentage of subjects, as well as the mean (SD) and median score for severity (none=0, mild=1, moderate=2, and severe=3), were summarized by treatment group and by visit for the following LSRs: erythema, edema, weeping/exudates, flaking/ scaling/dryness, and scabbing/crusting. Erosion and ulceration were also evaluated (none=0, erosion=1, and ulceration=2). A score of greater than 0 for the specified LSR was considered a treatment site reaction."|Weeks 2, 4, 6, 10, 14, 20, and 26|Safety population: all randomized subjects were presumed to have applied at least one application of study medication and were included in the safety population. This population was used for all safety analyses. Subjects were analyzed as treated.||participants|||Number
91262|NCT00894647|Secondary|Percent of Subjects With Complete Clearance|Proportion of subjects who achieved complete clearance of all AK lesions, cryosurgery-treated AK lesions, and non cryosurgery-treated AK lesions from baseline to Week 26/EOS in the ITT population.|Week 26|Intent to treat (ITT) population, last observation carried forward (LOCF)||percentage of participants||95% Confidence Interval|Number
91263|NCT00894647|Primary|Change From Baseline in Percentage of Lesion Count|The primary efficacy endpoint was a comparison between the active and placebo treatment groups of percent change from baseline in the total AK lesion count at Week 26. All AK lesions on the face were included in the analysis—treated and untreated AK lesions at baseline (defined as the AK lesion count just prior to cryosurgery) and new lesions that appeared post-baseline.|Week 26|Intent to treat population, Last Observation Carried Forward (LOCF)||percentage of lesion count||Standard Deviation|Mean
91264|NCT00894556|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.||attacks|Participants||Number
91265|NCT00894556|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.||attacks|Participants||Number
91266|NCT00894543|Secondary|Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries|Change in daily hot flash bother between baseline & week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|"Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).~Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment."||Scores on a scale||95% Confidence Interval|Mean
91267|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash severity between baseline & week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).||Scores on a scale||95% Confidence Interval|Mean
91268|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|"Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).||Scores on a scale||95% Confidence Interval|Mean
91269|NCT00894543|Secondary|Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries|"Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).||Scores on a scale||95% Confidence Interval|Mean
91270|NCT00894543|Primary|Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries|"Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).||Scores on a scale||95% Confidence Interval|Mean
91271|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.|week 8 minus baseline|||Hot flashes/day||95% Confidence Interval|Mean
91272|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.|week 4 minus baseline|||Hot flashes/day||95% Confidence Interval|Mean
91273|NCT00894543|Secondary|Daily Hot Flash Bother, Recorded on Daily Diaries|"Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).||Scores on a scale||95% Confidence Interval|Mean
91274|NCT00894543|Primary|Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries|Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.|Baseline|||Hot flashes/day||95% Confidence Interval|Mean
91275|NCT00894517|Secondary|Change From Baseline in Normal Sperm Morphology|Sperm Morphology was evaluated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Normal sperm morphology was assessed from slide smears sent to a central reading facility. A positive change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Percent||Standard Deviation|Mean
91276|NCT00894517|Secondary|Change From Baseline in Total Sperm Motility|Sperm motility was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Sperm motility was assessed using the CELL-VU chamber and was scored according to the World Health Organization criteria for sperm progression and motility. A total of at least 200 motile and immotile sperm were counted. A percent was determined by the calculation of motile sperm/total sperm count. A negative change from Baseline indicated a worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Percent||Standard Deviation|Mean
91277|NCT00894517|Secondary|Change From Baseline in Ejaculatory Volume|Ejaculatory volume was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume was measured using a standard pipette (measuring device). A negative change from Baseline indicated worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||milliliters (mL)||Standard Deviation|Mean
91278|NCT00894517|Secondary|Change From Baseline in Log Transformed Sperm Concentration|Sperm concentration was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Collected sperm samples were assessed using a CELL-VU® count chamber. The total number of sperm per 100 boxes on the chamber grid were counted. Sperm Concentration = total number of sperm counted in 100 boxes × dilution factor / 1 × 10^6 and is reported in millions per milliliter. Log transformation of the sperm concentration was used for analysis . The log transformed sperm concentration data has no units. A negative change from Baseline indicated a lower sperm concentration (worsening).|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Unitless||Standard Deviation|Mean
91279|NCT00894517|Primary|Percent Change in Total Sperm Count Per Ejaculate|Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.||Percent change||Standard Deviation|Mean
91280|NCT00894504|Secondary|Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab|Median PFS (95% CI), months, reported by biomarker expression/mutation status for: EGFR, p53, PTEN, PIK3CA, KRAS|18 months|Excludes patients in the following categories due to insufficient data: PTEN status unknown, PIK3CA Status unknown and KRAS no mutation||months||95% Confidence Interval|Median
91281|NCT00894504|Secondary|Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity|Assessments made through analysis of treatment-related adverse events and serious adverse events|every 6 weeks until discontinuation of treatment, expected average of 18 months|||participants|||Number
91282|NCT00894504|Secondary|Objective Response Rate and Clinical Benefit Rate|Estimated as the proportion of subjects who meet the criteria for complete or partial response (CR or PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 - for target lesions assessed by MRI: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions.|every 6 weeks until treatment discontinuation|All evaluable patients per RECIST v 1.1||Participants|||Number
91283|NCT00894504|Primary|Progression-free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions|every 6 weeks until treatment discontinuation|||Months||95% Confidence Interval|Median
91284|NCT00894465|Secondary|Anxiety Score From the State-Trait Anxiety Inventory|The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. This questionnaire was used to evaluate the anxiety level of the parents of the children who randomized to versed or placebo.|At the time of the procedure|||units on a scale||Standard Deviation|Mean
91285|NCT00894465|Primary|Anxiety Score From the Modified Yale Preoperative Anxiety Scale|The modified Yale preoperative scale consists of 5 categories (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Four of the five categories are scored between 1-4 points and one of the categories is scored from 1-6 points. The scores are divided by their number of possible points in their respective category and multiplied by 20 to get the final anxiety score which ranges from 20 to 100. Low numbers represent low anxiety and higher numbers represent high anxiety.|Waiting room, before catheterization, and after catheterization|||units on a scale||Standard Deviation|Mean
91471|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline|||participants|||Number
91286|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug.||Participants|||Number
91287|NCT00894387|Secondary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months|The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.|Baseline, 1 month, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point.||pg/mL||95% Confidence Interval|Least Squares Mean
91288|NCT00894387|Primary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.|6 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.||Participants|||Number
91289|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months||12 months|Full ananlysis set included all randomized patients who had at least one dose of study drug.||Participants|||Number
91290|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|6 months|Full analysis set included all randomized patients who had taken at least one dose of drug.||Participants|||Number
91291|NCT00894387|Secondary|Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months|Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0–100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.|Baseline, 1 months, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points.||units on a scale||Standard Error|Least Squares Mean
91292|NCT00894387|Secondary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.|12 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.||Participants|||Number
91293|NCT00894361|Primary|Knee Postoperative Range of Motion (ROM) at 2 Years|range of motion of the knee postoperatively at 2 years|2 years|||degrees||Standard Deviation|Mean
91294|NCT00894361|Secondary|Survival of the Implants to Subject Death or Implant Removal||10 or more years||||||
91295|NCT00894322|Primary|Time to Maximum Concentration (Tmax) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Tmax was measured in hours (h). Exenatide was measured using a validated ELISA. Tmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||hours||Standard Error|Geometric Mean
91296|NCT00894322|Primary|Maximum Concentration (Cmax) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Cmax was measured in pg/mL. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Cmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||pg/mL||Standard Error|Geometric Mean
91324|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Vital Sign Values|Criteria for clinically significant abnormal vital signs values: heart rate, ≤50 beats per minute (bpm) and decrease from baseline of ≥15 bpm; sitting systolic blood pressure, ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; sitting diastolic blood pressure, ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
91297|NCT00894322|Primary|Average Exenatide Concentration (Cave) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) and Cave(0-tlast) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h), and AUC (0-tlast), respectively. Cave was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10 - Week 11; Week 10 - Week 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||pg/mL||Standard Error|Geometric Mean
91298|NCT00894322|Primary|Area Under the Curve (AUC) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-6h) measured at Week 10, AUC (0-168h) steady state measured between Weeks 10 and 11, and AUC (0-tlast) for time interval between Weeks 10 and 12 (approximately336 hours) are presented below. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10-11; Weeks 10 - 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.||pg*hr/mL||Standard Error|Geometric Mean
91299|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Fasting Plasma Glucose in Participants With Diabetes (Cohort 2) for the ITT Population|Baseline was the last measurement at the screening visit. Fasting plasma glucose (FPG) was measured at screening, Day 1, Weeks 2, 4, 6, 8, 12, or early termination and reported in milligrams per deciliter (mg/dL).|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only participants in Cohort 2 were evaluated for this Outcome Measure.||mg/dL||Standard Error|Least Squares Mean
91300|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Body Weight in Participants With Diabetes (Cohort 2) in the ITT Population|Body weight was measured in kilograms (kg). Baseline was Day 1, last measurement prior to first dose of study drug. Body weight was measured at screening, Day 1, Weeks 4, 8, 12 or early termination and the LOCF approach was applied to estimate missing value at each post baseline timepoint.|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only Cohort 2 was analyzed for this outcome measure.||kg||Standard Error|Least Squares Mean
91301|NCT00894322|Secondary|Number of Participants Achieving HbA1c Less Than Equal to (<=) 6.5% and Less Than (<) 7% at Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. LOCF was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Week 12|ITT population included all participants treated with at least one dose of study drug. Only those ITT participants in Cohort 2 were analyzed.||participants|||Number
91302|NCT00894322|Secondary|Least Square Mean Change From Baseline in Hemoglobin A1c (HbA1c) to Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. Last observation carried forward (LOCF) was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug. This analysis was only done in Cohort 2 so the ITT population of Cohort 2 was available for analysis.||Percent of hemoglobin||Standard Error|Least Squares Mean
91303|NCT00894322|Primary|Antibody Titers for Participants With Treatment Emergent Positive Antibodies to Exenatide in Participants Who Received Exenatide in Cohorts 1 and 2|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1. Negative titers were assigned a value of 1 in order to calculate geometric mean. Geometric mean of reportable titers, by study week, are presented below.|Day 1 to Week 12|Only participants who received exenatide were analyzed (no placebo-treated participants were included). N=number of participants in each treatment at each visit and n= number of participants with reportable titers at the visit. Last visit=last visit with reportable titers.||Reportable Titers||Standard Error|Geometric Mean
91304|NCT00894322|Primary|Number of Participants With Hematology and Serum Chemistry Laboratory Values of Potential Clinical Importance in Cohorts 1 and 2 in ITT Population|Abbreviations: Upper Limit of Normal (ULN); milligram per deciliter (mg/dL); units per liter (U/L); micro liters (µL); creatine kinase (CK); gamma-glutamyltransferase (G-GT). Normal ranges = Hematocrit: 40.6-52.3% (male), 35.3-47.0 (female); Platelets 155-361*10^3/µL(male/female); Calcium: 8.6-10.4 mg/dL (male/female); CK: 43-350 U/L (male), 28-207 U/L (female); G-GT: 7-62 U/L (male/female); Glucose 73-105 mg/dL (male/female); Lipase 14-70 U/L (male/female); Uric acid: 3.5-7.8 mg/dL (male), 2.3-5.9 mg/dL (female). Blood samples for laboratories were collected at screening, Day 1, Weeks 4, 8, 12 or early termination. Value for potential clinical importance is presented in each category presented below.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.||participants|||Number
91325|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values|Participants with at least one clinically significant postbaseline urinalysis abnormality, specifically presented is blood (hemoglobin) in urine >=2 units increase from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
91305|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Heart Rate in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Heart rate was measured in beats per minute (bpm). In Cohort 2, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12|||bpm||Standard Deviation|Mean
91306|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Diastolic and Systolic Blood Pressure in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Blood pressures (diastolic and systolic) were measured in millimeters of mercury (mmHg). In Cohort 2, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.||mmHg||Standard Deviation|Mean
91307|NCT00894322|Secondary|Average Exenatide Concentration (Cave) of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single dose, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h) and was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.||pg/mL||Standard Error|Geometric Mean
91308|NCT00894322|Secondary|AUC (0 Hour to 168 Hour) for 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC (0-168 h) data represents average concentration rather than maximum concentration. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y and measured in pg*h/mL. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.||pg*h/mL||Standard Error|Geometric Mean
91309|NCT00894322|Primary|Number of Participants With Concomitant Medications in Cohort 1 and Cohort 2 in ITT Population|Concomitant medications are defined as those medications received on or after the date of the first injection on Day 1, including prior medications that continued past Day 1 and new concomitant medications. Participants may be counted in more than one medication class and no more than once in each class. Categories by Anatomical Therapeutic Chemical (ATC) classification using the World Health Organization (WHO) Drug Dictionary version C1, 01 March 2009. As per protocol, all participants in Cohort 1 could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide.|Day 1 to 12 weeks|ITT population included all participants treated with at least one dose of study drug.||participants|||Number
91310|NCT00894322|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Injection Site TEAEs, Serious Adverse Events (SAEs), Deaths, and Withdrawals Due to AEs in Cohort 1 and Cohort 2 in Intent to Treat (ITT) Population|Treatment emergent (TE)=occurs during or after treatment with study drug. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Participants experiencing multiple episodes of a given AE are counted once. Injection site AEs: adverse events that existed prior to Day 1 and worsened after the first administration at Day 1, or occurred after the first administration at Day 1 through Week 12, or after Study Termination if considered by investigator to be clinically significant.|Day 1 to Week12|ITT population included all participants treated with at least one dose of study drug.||participants|||Number
91311|NCT00894322|Primary|Time to Maximum Concentration (Tmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time(t) = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 an the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Tmax was measured in hours and Tmax (0-8h) and (0-tlast) are presented below. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] and had reliable PK data.|Day 1, Week 12|PK evaluable population. n=number of participants who had reliable PK data available to be evaluated.||hours||Standard Error|Geometric Mean
91312|NCT00894322|Primary|Maximum Concentration (Cmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cmax was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 for the evaluation of the PK characteristics of plasma exenatide and had reliable PK data. Cmax (0-8h) and (0-tlast) are presented below.|Day 1, Week 12|PK evaluable population.||pg/mL||Standard Error|Geometric Mean
91313|NCT00894322|Primary|Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-8h) and (0-tlast) are presented below. Pharmacokinetic (PK) evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1, Week 12|PK evaluable population was analyzed. n in categories below = number of ITT participants with PK evaluable data.||pg*h/mL||Standard Error|Geometric Mean
91314|NCT00894244|Primary|The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)|The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment|immediately following treatment and 30 days after last treatment|||millimeters||95% Confidence Interval|Number
91315|NCT00894166|Secondary|Continuous Abstinence From Smoking at 6 Months Post Quit.||continuous abstinence at 6 months post quit day|||percentage of subjects|||Number
91316|NCT00894166|Secondary|Abstinence (7 Days) at 6 Months.||point abstinence (7 days) at 6 months post-quit date|||percentage of subjects|||Number
91317|NCT00894166|Primary|Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)|A self report of no cigarettes smoked confirmed by expired air carbon monoxide of <=10ppm was the criterion for abstinence.|weeks 8-11 after quit date|All participants were included in the analyses except those dropping out prior to randomization points, those censored for taking contraindicated medications or failing to meet other inclusion criteria, and one death having no apparent relationship to treatment.||percentage of subjects abstinent||95% Confidence Interval|Number
91318|NCT00894127|Primary|Determine the Clinical Sensitivity and Specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay Using Sputum Specimens From Two Cohorts of Participants and Estimate the Required Sample Size to Finalize a Protocol for a Pivotal Study.|"Various measurements were taken to report the validity of the findings. Sensitivity in this study was defined as the percentage of tumor cells that were positively identified. Specificity was the percentage of true positive signals and accuracy calculated as the percentage of those patients identified as having cancer.~Testing for the study was performed at multiple locations to assess the efficacy of the CyPath Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the study and assigned to one of two cohorts (smoker with clear Low dose CT scan or high-risk normals, and lung cancer confirmed by pathology or cancer)."|March 2011|||percentage|||Number
91319|NCT00893997|Primary|Number of Patients With Clinical Response|Clinical response based on the International Working Group (IWG) Response Criteria in myelodysplastic syndromes (MDS): 'Complete Response' or Hematologic Improvement' and 'No Clinical Response'. Clinical responses as assessed by standard criteria with bone marrow biopsy, cytogenetic studies (standard chromosome banding) and molecular studies 3 weeks after the last vaccination.|At 29 weeks|Analysis on patients treated; study terminated early.||participants|||Number
91320|NCT00893997|Primary|Patient Immunologic Response|Patients assessed after 4th vaccination for immunologic response categorized as 'Immunologic-Responders' or 'Non-Responders.' Immune response defined as an increase of ≥ 0.5 PR1-HLA-A2 tetramer cells/μl compared to the pre study absolute PR1-HLA-A2 tetramer cells/μl. Time period 29 weeks after study entry, with week 0 corresponding to 1st injection, and 8th injection thus being given at week 25, 29 weeks corresponds to 13 weeks after receipt of a 4th injection.|29 weeks|Analysis on patients treated; study terminated early.||participants|||Number
91321|NCT00893789|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP, defined as last postbaseline observation, up to Week 12). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT=head, eyes, ears, nose, throat.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|For each category, only participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.||participants|||Number
91322|NCT00893789|Secondary|Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Shifts (normal and abnormal) from baseline to overall are summarized using participant counts. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|Participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.||participants|||Number
91323|NCT00893789|Secondary|Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure, ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure, ≥90 mm Hg plus increase of ≥10% from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
91388|NCT00892957|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set||percent change||Full Range|Median
91326|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values|Normal ranges for hematology values: white blood cell (WBC) count, 3.8 - 10.7 x 10^9/L; absolute neutrophil count (ANC), 1.96 - 7.23 x 10^9/L. Participants may have had more than one clinically significant abnormal value.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
91327|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values|Normal ranges for serum chemistry values: blood urea nitrogen (BUN), 1.43 - 8.57 mmol/L; uric acid, 124.91 - 493.68 μmol/L; aspartate aminotransferase (AST), 11 - 36 U/L; gamma-glutamyl transpeptidase (GGT), 10 - 61 U/L; total bilirubin, 3.42 - 20.52 μmol/L.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.||participants|||Number
91328|NCT00893789|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs|AE=any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis (including hypomanic or manic episode), and seizure or suspected seizure were considered to be of potential clinical importance.|Screening through Week 12|Safety Analysis Set (all participants who received 1 or more doses of study drug).||participants|||Number
91329|NCT00893789|Secondary|Concomitant Medication Usage In ≥5% of Participants Throughout the Study|Therapeutic classification of concomitant medications used by ≥5% of participants throughout the study. Participants are counted only once in each therapeutic class category. Medications were included in the table if the proportion of participants in the combined armodafinil treatment group was ≥5%.|Screening through Week 12|All randomized participants||participants|||Number
91330|NCT00893789|Secondary|Plasma Concentrations of Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) at Weeks 4, 8, and 12 (or Last Postbaseline Observation Up to Week 12)|To evaluate the impact of treatment with armodafinil on the pharmacokinetics of selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) (as appropriate), plasma concentrations at weeks 4, 8, and 12 (or last postbaseline observation) were to be assessed.|Weeks 4, 8, and 12 (or last postbaseline observation, up to Week 12)|Due to the limited samples available for measurement of concentrations of antidepressants in the study, the plasma concentrations of antidepressants were not measured. The planned pharmacokinetic evaluation of the impact of armodafinil treatment on the pharmacokinetics of selective antidepressants was not conducted.|||||
91331|NCT00893789|Secondary|Change From Baseline in the Total Sleep Time As Assessed by Nocturnal Polysomnography (NPSG) at Weeks 2, 4, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|NPSG continuously records normal and abnormal physiological activity during an entire night. It documents the adequacy of sleep, including the frequency, duration, and total amounts of stage 1-2, stage 3-4 (slow wave sleep), and rapid eye movement (REM) sleep.|Baseline, Weeks 2, 4, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Safety Analysis Set (all participants who received 1 or more doses of study drug); n=number of participants with data at given time point.||minutes||Standard Deviation|Mean
91332|NCT00893789|Secondary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression and scores less than 12 indicate mild depression."|Baseline, Weeks 2, 4, 8, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Participants in the Safety Analysis Set (participants who received 1 or more doses of study drug) with a baseline S-HAM-D6 measurement; n=number of participants with nonmissing data at given time point.||units on a scale||Standard Deviation|Mean
91333|NCT00893789|Secondary|"Percentage of Participants Answering No to All Questions on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)"|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). The number of participants answering 'no' to all 9 yes/no questions about suicidal behaviors, ideations, and acts are presented. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Safety analysis set (all participants who received 1 or more doses of study drug); n=all participants with a nonmissing value at given time point.||percentage of participants|||Number
91334|NCT00893789|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|The patient’s evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient’s propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered.|Baseline, Week 12, Endpoint (last postbaseline observation, up to Week 12)|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time point.||units on a scale||Standard Deviation|Mean
91335|NCT00893789|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Total Score At Weeks 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|The TBI-WIS is a validated participant-rated instrument for assessing a participant’s functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a “true” or “not true” answer. To score the questionnaire, the number of “true” responses is counted: if < 2, the risk is low; 2 to 23, the risk is medium; and >23, the risk is high, for work instability. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability).|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Participants in the Full Analysis Set (participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment) with a baseline TBI-WIS measurement; n=number of participants with values at given time points.||units on a scale||Standard Deviation|Mean
91336|NCT00893789|Secondary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12|The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Weeks 2, 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with a nonmissing value at given time point.||percentage of participants|||Number
91337|NCT00893789|Secondary|Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, Weeks 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time points.||minutes||Standard Deviation|Mean
91338|NCT00893789|Primary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)|The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment).||percentage of participants|||Number
91339|NCT00893789|Primary|Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. If a participant did not fall asleep in 20 minutes, his/her sleep latency for that nap was set to 20 minutes. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with measurements at given time point.||minutes||Standard Deviation|Mean
91340|NCT00893763|Secondary|Serum Procalcitonin||5 days||||||
91341|NCT00893763|Secondary|Serum Cytokines||5 days||||||
91342|NCT00893763|Secondary|Endotracheal Tube Colonization|semiquantitative swab culture for potentially pathogenic organisms of distal end of the endotracheal tube (ETT) interior lumen at extubation. Results were collapsed into two categories: colonization (moderate or many organisms) or no colonization.|24 hours|The subjects analyzed were a subset of subjects enrolled in the study from whom endotracheal tunes were obtainable for microbial culture post-intubation. Subset analysis was planned a priori.||percentage of ET tubes colonized|||Number
91389|NCT00892957|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||mm Hg||Full Range|Median
91390|NCT00892957|Secondary|Number of Participants With Infections by Grade|"Infections were recorded according to:~Grade I: only dermis affected~Grade II: infection invades subcutaneous region but not the arterial implant~Grade III: the arterial implant is infected"|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set||participants|||Number
91343|NCT00893763|Primary|Development of VAP (Clinical Pulmonary Infection Score)|Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP.|Baseline up to 5 days|Subjects who had complete CPIS data on admission to the study (Day 0) and subsequent complete CPIS data from day 2, 3, 4 or 5 (47 CHX & 47 control, 438 observations) were included in the analysis in accordance with intent to treat analysis principles.||units on a scale||Standard Error|Mean
91344|NCT00893737|Primary|Change in Scores From Completeness of Response Survey (CORS)|"CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.~The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication)."|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)|||Units on a scale||95% Confidence Interval|Mean
91345|NCT00893737|Secondary|Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)|Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)|||Units on a scale||95% Confidence Interval|Mean
91346|NCT00893737|Secondary|Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan|CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)|||Percent of Participants|||Number
91347|NCT00893464|Secondary|Overall Best Response|Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD. PD is any new lesion or increase by >50% of previously involved sites from nadir.|Baseline up to Cycle 45|Response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 postbaseline disease assessment for analyses of response.||participants|||Number
91348|NCT00893464|Secondary|TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib|TEmax: Time to reach the maximum observed effect (Emax), equal to time (hours) to Emax.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.||hr||Full Range|Median
91349|NCT00893464|Secondary|Emax: Maximum Observed Effect for Ixazomib|Emax is the maximum inhibition of 20S proteasome activity in whole blood.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.||percentage of inhibition||Standard Deviation|Mean
91350|NCT00893464|Secondary|CLr: Renal Clearance|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr).|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. CLr is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.||L/hr||Standard Deviation|Geometric Mean
91351|NCT00893464|Secondary|Fe (0-4): Fraction of Dose Excreted Unchanged in Urine From 0 to 4 Hours Postdose|Fe (0-4) is the fraction of the dose excreted unchanged in the urine from 0 to 4 hours postdose, calculated as percentage of the exact dose administered.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population was defined as participants who had sufficient dosing data and ixazomib concentration-time data to permit the calculation of PK parameters where Days 1 and 15 assessments were available.||percentage of dose||Standard Deviation|Geometric Mean
91352|NCT00893464|Secondary|Ae (0-4): Amount of Drug Excreted in Urine From 0 to 4 Hours Postdose|Ae (0-4) is the total amount of drug excreted in the urine from 0 to 4 hours postdose.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.||nanogram||Standard Deviation|Geometric Mean
91353|NCT00893464|Secondary|Rac: Accumulation Ratio for Ixazomib|Rac was estimated as the ratio of AUC (0-168) on Day 15 and AUC (0-168) on Day 1. AUC (0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Rac is reported for ixazomib 1.4, 2.34 and 3.11 mg/m^2 groups only as it could not be estimated for the other dosing groups.||ratio||Standard Deviation|Geometric Mean
91354|NCT00893464|Secondary|Terminal Phase Elimination Half-life (T1/2) for Ixazomib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Cycle 1 Day 15: Predose and at multiple time points (up to 336 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters.T1/2 is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.||hr||Standard Deviation|Geometric Mean
91355|NCT00893464|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration time-curve from time 0 to 168 hours postdose|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. AUC(0-168) is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
91356|NCT00893464|Secondary|C0: Initial Plasma Concentration After Bolus Intravenous Administration|C0 is the plasma drug concentration at time zero following bolus intravenous injection, obtained from the plasma concentration-time curve.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 336 hours postdose)|The pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
91357|NCT00893464|Primary|Recommended Phase 2 Dose (RP2D)|The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.|Baseline up to Treatment Cycle 45|Safety population included all participants who received at least 1 dose of ixazomib.||mg/m^2|||Number
91358|NCT00893464|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of ixazomib that generated dose limiting toxicity (DLT) during Cycle 1 in 0 of 3 or 1 of 6 participants. DLT defined as any of the following considered possibly related to therapy by investigator: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; platelet count <25,000 cells/mm^3; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by maximal supportive therapy; Grade 3 QTc prolongation>500 millisecond (msec);any >=Grade 3 nonhematologic toxicity except arthralgia/myalgia; <1 week fatigue; delay in the initiation of the subsequent therapy cycle by >=7 days ; other Grade 2 ixazomib-related nonhematologic toxicities requiring therapy discontinuation.|Treatment Cycle 1|DLT-Evaluable Population included participants who received all Cycle 1 doses of MLN9708 and who completed Cycle 1. If Cycle 1 was interrupted by a DLT, the participant was included in this population.||mg/m^2|||Number
91359|NCT00893464|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, weight, systolic and diastolic blood pressure and heart rate.|Baseline and Days 1, 8, 15 of each treatment cycle up to 45 treatment cycles|Safety population included all participants who received at least 1 dose of ixazomib.||participants|||Number
91360|NCT00893464|Primary|Number of Participants Reporting at Least 1 TEAE Related to Laboratory Assessments|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology, clinical chemistry and urinalysis were performed. TEAEs related to laboratory assessment observed at any time-points were reported under 3 system organ classes: blood and lymphatic system disorders, metabolism and nutrition disorders, and investigations.|Baseline and Days 1, 8, and 15 of each treatment cycle (up to Cycle 45)|Safety population included all participants who received at least 1 dose of ixazomib.||participants|||Number
91361|NCT00893464|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of ixazomib.||participants|||Number
91362|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.||cells/μL||Standard Deviation|Mean
91363|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 24|The change from baseline in CD4 cell count at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.||cells/μL||Standard Deviation|Mean
91364|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
91365|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 24|The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
91366|NCT00892437|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set||percentage of participants|||Number
91367|NCT00892437|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.|Week 24|ITT Analysis Set: participants who were randomized and received at least one dose of study drug.||percentage of participants|||Number
91368|NCT00893152|Primary|Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment|"This is qualitative research. Outcomes were themes raised with regard to content to be included in a multi-family group psychoeducation program for OEF/OIF/OND veterans with PTSD and family members."|During the 1-1.5 hour interviews|Participants in focus group or individual qualitative interviews||participants|||Number
91369|NCT00893113|Secondary|Change in Total International Index of Erectile Function (IIEF) Score|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.||Change in Total IIEF Score from Baseline||Standard Deviation|Mean
91370|NCT00893113|Secondary|Changes in American Urological Association (AUA) Symptom Index|The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.||Change in AUA Score From Baseline||Standard Deviation|Mean
91371|NCT00893113|Primary|Change From Baseline Erectile Function Domain of the International Index of Erectile Function|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.||Change in EF Domain Score from Baseline||Standard Deviation|Mean
91372|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||95% Confidence Interval|Number
91373|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Moderate bleeding defined as:~Either >25% of the suture line bleeds, or~≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or~1 pulsatile suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||95% Confidence Interval|Number
91374|NCT00892957|Secondary|Laboratory Values Over Time: International Normalized Ratio(INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||ratio||Full Range|Median
91375|NCT00892957|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||seconds||Full Range|Median
91376|NCT00892957|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||U/L||Full Range|Median
91377|NCT00892957|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||U/L||Full Range|Median
91378|NCT00892957|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||mg/dL||Full Range|Median
91379|NCT00892957|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||x10^3/µl||Full Range|Median
91380|NCT00892957|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||x10^3/µl||Full Range|Median
91381|NCT00892957|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||x10^6/µl||Full Range|Median
91382|NCT00892957|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||percentage of red blood cells in blood||Full Range|Median
91383|NCT00892957|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set||g/dL||Full Range|Median
91384|NCT00892957|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set||percent change||Full Range|Median
91385|NCT00892957|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||breaths per minute||Full Range|Median
91386|NCT00892957|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set||percent change||Full Range|Median
91387|NCT00892957|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||beats per minute||Full Range|Median
91398|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number. Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters cubed||Standard Deviation|Mean
91399|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred, because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number. A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
91400|NCT00892723|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in a scrambled order. Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately. Data from the two raters was not combined.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
91401|NCT00892723|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Units on a scale||Standard Deviation|Mean
91402|NCT00892710|Secondary|6-month and 12-month Overall Survival Probability|Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|12 months|Includes all enrolled patients, whether or not they received treatment||probability out of 1||95% Confidence Interval|Number
91403|NCT00892710|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all enrolled patients, whether or not they were treated||months||95% Confidence Interval|Median
91404|NCT00892710|Secondary|Time to Treatment Failure (TTTF)|Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.|18 months|Includes all treated patients||months||Full Range|Median
91405|NCT00892710|Secondary|Time to Progression (TTP)|The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all treated patients||months||95% Confidence Interval|Median
91406|NCT00892710|Secondary|Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all treated patients||participants|||Number
91407|NCT00892710|Primary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all enrolled patients whether they recieved treatment or not||months||95% Confidence Interval|Median
91408|NCT00892697|Secondary|Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir|Intrahepatic and plasma telaprevir concentration ratios|Day 1, Day 4, Day 15, Week 8|||telaprevir liver to plasma conc ratio||Inter-Quartile Range|Median
91409|NCT00892697|Primary|Intrahepatic and Plasma HCV Viral Kinetics|Intrahepatic viral kinetics, plasma viral kinetics,|Day-7, Day 1, Day 4,|||log transformed copies/ml||Standard Deviation|Mean
92903|NCT00877929|Secondary|SBP Control 140 at Two Weeks|Mean seated SBP < 140 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
91410|NCT00892281|Secondary|Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)|Number of treatment responders at week 12, where response is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (near clear). IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best and 4 being worst.|Baseline to Week 12|||participants|||Number
91411|NCT00892281|Secondary|Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Clinician's Erythema Assessment Scale (CEA) score. Clinician's Erythema Assessment Scale (CEA) is a scale from 0 - 4 with 0 = None; 1 = Mild; 2 = Moderate; 3 = Significant; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12 in CEA.|Baaseline to Week 12|||participants|||Number
91412|NCT00892281|Primary|Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.|Baseline to Week 12|Per protocol||participants|||Number
91413|NCT00892151|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3|"User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses.||participants|||Number
91414|NCT00892151|Secondary|Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:~= Very Simple~= Simple~= Neither Simple nor Difficult~= Difficult~= Very Difficult"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes; the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.||percentage of participants|||Number
91415|NCT00892151|Primary|Number of Participants Rated Successful (<=3) at Performing Specific Tasks|"Study staff rated participants on their success at perfoming specific tasks. The rating scale was:~= Successful~= Successful after being referred to user instructions~= Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~= Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)~= Problem encountered with software"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.||participants|||Number
91416|NCT00892099|Secondary|Cardiac Hospitalizations and Mortality||1 year||||||
91417|NCT00892099|Secondary|Infectious Hospitalizations and Mortality||1 year||||||
91418|NCT00892099|Secondary|All Cause Hospitalizations and Mortality||1 year||||||
91419|NCT00892099|Secondary|Plasma Cathelicidin||every 4 weeks for 12 weeks||||||
91420|NCT00892099|Secondary|Serum 1,25-dihydroxyvitamin D Levels||every 4 weeks for 12 weeks||||||
91421|NCT00892099|Secondary|Parathyroid Hormone||Every 4 weeks for 12 weeks||||||
91422|NCT00892099|Secondary|Serum Phosphate||every 4 weeks for 12 weeks||||||
91423|NCT00892099|Secondary|Serum Calcium||every 4 weeks for 12 weeks||||||
91424|NCT00892099|Secondary|Cytokine Profiles||every 4 weeks for 12 weeks||||||
91425|NCT00892099|Primary|Serum 25D Level||12 weeks|||ng/ml||Standard Deviation|Mean
91426|NCT00892047|Secondary|QTc Prolongation on EKG (to Greater or Equal to 480 Msec)|percentage of participants|12 weeks|We had a smaller number of participant observations due to dropouts and missing data. This data is in Table 3 of the manuscript.||percent of participants|||Number
91427|NCT00892047|Secondary|Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment|percentage of participants who reported suicidal ideation during treatment but not at baseline|12 weeks|It is a smaller number of participants restricted to those who did not report any suicidal ideation at baseline. This is in Table 3of the manuscript||percent of participants|||Number
91428|NCT00892047|Primary|Parkinsonism|Percentage of participants who develop signs of parkinsonism|12weeks|We have a lower number of participants analyzed due to dropouts and missed assessments.||percentage of participants|||Number
91429|NCT00892047|Primary|Weight|Weight change in kilograms|Baseline through12 weeks|The number of participants analyzed is lower due to missing data attributable to dropouts. The information obtained is from figure 3B in the manuscript||kilograms||Standard Deviation|Mean
91430|NCT00892047|Primary|Akathisia|Percentage of participants who developed clinically significant akathisia.|12 weeks|||percentage of participants|||Number
91431|NCT00892047|Primary|Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS.|12 weeks|||percentage of participants|||Number
91432|NCT00892008|Primary|Discontinuations Due to Adverse Events|Discontinuations due to adverse events by MedDRA system organ class and preferred term.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Safety population: all subjects who took at least one dose of study medication.||participants|||Number
91433|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit|Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91434|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist|Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91435|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91436|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91437|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91438|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91439|NCT00892008|Secondary|VAS Pain Score at Baseline and Final Visit|VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.|Baseline, Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91440|NCT00892008|Secondary|VAS Pain Score at Baseline (BL) and Second Visit|VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .|Baseline, Second Visit (Week ≥ 2)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.||participants|||Number
91441|NCT00892008|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N = number of subjects with a Visual Analog Scale (VAS) pain score at Baseline Visit.||scores on scale||Standard Deviation|Mean
91442|NCT00892008|Primary|Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)|Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.|Baseline through Final Visit (Week 4)|Safety population: all subjects who took at least 1 dose of study medication.||participants|||Number
91443|NCT00891995|Secondary|BMI Percentile||1 year|||percent||Inter-Quartile Range|Median
91444|NCT00891995|Secondary|Daily Insulin Dose||1 year|||u/day/kg||Standard Deviation|Mean
91445|NCT00891995|Secondary|CGM Measured Glucose Outcomes|Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.|1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.||percent||Inter-Quartile Range|Median
91446|NCT00891995|Secondary|CGM Mean Glucose||1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.||mg/dL||Inter-Quartile Range|Median
91447|NCT00891995|Secondary|Adverse Events (Severe Hypoglycemia)||1 year|||participants|||Number
91448|NCT00891995|Secondary|HbA1c||1 year|||percent||Standard Deviation|Mean
91449|NCT00891995|Secondary|Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT|Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.|0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.||participants|||Number
91450|NCT00891995|Secondary|Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment||0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.||pmol/ml||95% Confidence Interval|Geometric Mean
91451|NCT00891995|Primary|C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.|In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).|At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.||pmol/ml||95% Confidence Interval|Geometric Mean
91452|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4|||Participants|||Number
91453|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2|||Participants|||Number
91454|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1|||Participants|||Number
91455|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/Baseline|||Participants|||Number
91456|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4|||Participants|||Number
91457|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2|||Participants|||Number
91458|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1|||Participants|||Number
91459|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline|||Participants|||Number
91460|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4|||Participants|||Number
91461|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2|||Participants|||Number
91462|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1|||Participants|||Number
91463|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline|||Participants|||Number
91464|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4|||Participants|||Number
91465|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2|||Participants|||Number
91466|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1|||Participants|||Number
91467|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline|||Participants|||Number
91468|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4|||participants|||Number
92904|NCT00877929|Secondary|SBP Control 140 at Four Weeks|Mean seated SBP < 140 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
91472|NCT00891930|Secondary|Number of Subjects With Worst Post-baseline Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded using CTCAE v3.0.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2||participants|||Number
91473|NCT00891930|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where 1 = Mild [aware of sign or symptom, but easily tolerated]; 2 = Moderate [discomfort enough to cause interference with usual activity]; 3 = severe [incapacitating with inability to work or do usual activity]; 4 = life-threatening; 5 = fatal), with the exception of selected skin toxicities that were graded using a modified version of CTC. Treatment-related adverse events were those events for which the investigator considered there to be a reasonable possibility that the event may have been caused by panitumumab (Part 1) and by panitumumab and/or ganitumab (Part 2). Discontinuation includes AEs leading to discontinuation of panitumumab (Part 1) and panitumumab, ganitumab (Part 2) or removal from the study.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2||participants|||Number
91474|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Ganitumab|Two validated assays were used to detect the presence of anti-ganitumab antibodies. First, an eletrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding ganitumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against ganitumab.|From first dose of ganitumab until 30 days after last dose; median time frame was 2.4 months.|Primary Analysis Set - Part 2 particpants with at least 1 post-baseline immunoassay result.||participants|||Number
91475|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. Postive samples were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay.|From first dose date to 30 days since the last dose date. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 participants with at least 1 post-baseline immunoassay result.||participants|||Number
91476|NCT00891930|Secondary|Duration of Response|Duration of response is defined as the time from the first confirmed objective response to the earlier date of disease progression or death. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response||months||95% Confidence Interval|Median
91477|NCT00891930|Secondary|Time to Objective Response|Time to objective response was defined as the time from first dose of study drug to the first confirmed objective response. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the end of treatment in each Part; median duration of treatment was 16 weeks in Part 1 and 8 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response||months||Full Range|Median
91478|NCT00891930|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first dose of study therapy in Part 1 or Part 2 to the date of death. Participants who had not died by the analysis data cutoff date were censored at their last contact date.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1 and Part 2||months||95% Confidence Interval|Median
91479|NCT00891930|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the interval from the first dose of study therapy to the earlier date of disease progression (per modified RECIST version 1.0) or death prior to the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 2 where applicable. Participants who had not progressed or died during this period were censored at their last evaluable disease assessment date. Progressive Disease (PD): At least a 20% increase in the size of target or non-target lesions, significant increase in pleural effusions, ascites, or other fluid collections with cytologic proof of malignancy, or any new lesions.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1: participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan. Part 2: participants who had radiographically confirmed disease progression on treatment in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2.||months||95% Confidence Interval|Median
91480|NCT00891930|Secondary|Part 1: Objective Response Rate|"Objective response rate is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified RECIST version 1.0 criteria during the treatment period.~Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From first dose of study drug until the end of treatment in Part 1; median duration of treatment was 16 weeks.|Tumor Response Evaluable Analysis Set – Part 1 (participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with at least one Baseline uni-dimensionally measurable lesion per the RECIST version 1.0 based on investigators’ review).||percentage of participants||95% Confidence Interval|Number
91494|NCT00891813|Secondary|Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL|Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.|24 Weeks|||Weeks||Inter-Quartile Range|Median
92905|NCT00877929|Secondary|SBP Control 140 at Six Weeks|Mean seated SBP < 140 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
91481|NCT00891930|Primary|Part 2: Objective Response Rate (ORR)|Objective response rate (ORR) is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression (increase in size) of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From the first dose of study drug in Part 2 until the end of treatment in Part 2; median duration of treatment in Part 2 was 8 weeks.|Tumor Response Evaluable Analysis Set - Part 2 (participants who had radiographically confirmed disease progression on panitumumab and irinotecan in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2 and with at least 1 baseline uni-dimensionally measurable lesion per the RECIST v1.0 based on investigators’ review.||percentage of participants||95% Confidence Interval|Number
91482|NCT00891930|Primary|Part 1: Emergence of Mutant KRAS|Mutation in Kirsten rat sarcoma-2 virus oncogene (KRAS) status was determined by examining KRAS exons 2, 3, and 4. The emergence of mutant KRAS was defined as a change in KRAS mutation status from wild-type at Baseline in KRAS exons 2, 3, and 4 to mutant in any of KRAS exons 2, 3, and 4 at the time of the second biopsy following the radiographic evidence of acquired resistance to panitumumab when given in combination with irinotecan.|From first dose of study drug until the 2nd biopsy at the time of disease progression/entry into Part 2; median duration of treatment in Part 1 was 16 weeks.|KRAS analysis set (participants with known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with known KRAS status at baseline and at acquired disease resistance to panitumumab in combination with irinotecan (i.e., based on the results of the second biopsy on study).||percentage of participants||95% Confidence Interval|Number
91483|NCT00891904|Secondary|Overall Survival||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter|Trial terminated early. Too few patients to analyze.|||||
91484|NCT00891904|Secondary|Local and Distant Control||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.|Trial terminated early. Too few patients to analyze.|||||
91485|NCT00891904|Secondary|Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients||2 years|Trial terminated early. Too few patients to analyze.|||||
91486|NCT00891904|Primary|Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30||Daily while on Treatment|Trial terminated early. Too few patients to analyze.|||||
91487|NCT00891839|Secondary|Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG scale is:~Grade 0: Fully active, able to carry on all pre-disease activities without restriction;~Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;~Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;~Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours;~Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.~The shift table compares baseline ECOG scores to the ECOG scores as of the last treatment visit."|Day 0 (baseline) up to Month 8|Safety population. One participant dropped out prior to obtaining a post-treatment ECOG evaluation.||participants|||Number
91488|NCT00891839|Secondary|Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)|Participants had a whole-body PET at baseline and at the end of cycle 6 or the end-of-treatment visit. Negative PET refers to PET results showing no abnormal lymph nodes; conversely, positive PET refers to PET results showing abnormal lymph nodes.|Baseline (Days -30 to 0), post treatment (up to Month 9, 30 days following completion of therapy)|Safety population of participants with PET data||participants|||Number
91489|NCT00891839|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival is defined as the time from first exposure to study medication to death, or to last date from adverse events, concomitant medications, vital signs, lost to follow-up, or last known alive, for overall survival censoring date.|Day 1 up to Month 57|Safety population||months||95% Confidence Interval|Median
91490|NCT00891839|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression-free survival is defined as the time from first exposure to study medication to disease progression or relapse, or death due to any cause. Progression is defined using the 2007 International Working Group criteria, as any new lesion or increase by at least 50% of previously involved sites from nadir.|Day 1 up to Month 45|Safety population||months||95% Confidence Interval|Median
91491|NCT00891839|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response is defined as the time between the date of the first response to date of progression or death. Response is determined on the basis of the 2007 IWG criteria. A complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Day 1 up to Month 43|Safety population of participants who had a response.||months||95% Confidence Interval|Median
91492|NCT00891839|Primary|Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria|"The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.~95% CIs are calculated using binomial exact method."|Month 3 (end of cycle 3), Month 6 (end of cycle 6)|Safety population consisting of all participants treated with at least 1 dose of bendamustine HCL.||percentage of participants||95% Confidence Interval|Number
91493|NCT00891813|Secondary|Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).|The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.|24 Weeks|||Number of participants|||Number
91495|NCT00891813|Primary|The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL|The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.|24 weeks|Analysis is based on the number of participants completing the study.||Percentage of participants|||Number
91496|NCT00891774|Secondary|Subject’s Satisfaction of the Overall Treatment||1, 3 and 6 months post injection||||||
91497|NCT00891774|Secondary|Investigator’s Satisfaction of the Overall Treatment||1, 3 and 6 months post injection||||||
91498|NCT00891774|Secondary|Reduction in Wrinkle Severity Score||Baseline, 1, 3 and 6 months post injection||||||
91499|NCT00891774|Primary|Safety Endpoint|Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation|6 months post injection|||Participants|||Number
91500|NCT00891735|Secondary|Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12|The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm^2.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Disc area units||Standard Deviation|Mean
91501|NCT00891735|Secondary|Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||mm^3||Standard Deviation|Mean
91502|NCT00891735|Secondary|Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||µm||Standard Deviation|Mean
91503|NCT00891735|Secondary|Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12|The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness < 270 µm.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
91504|NCT00891735|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
91505|NCT00891735|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
91506|NCT00891735|Secondary|Number of Ranibizumab Injections up to But Not Including Month 12||Baseline to Month 12|All treated patients. Observed data were used with no imputation.||Injections||Standard Deviation|Mean
91507|NCT00891735|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.||Letters||Standard Deviation|Mean
91508|NCT00891657|Primary|Area of Sites Adherent to the Uterus (cm^2)||8-12 weeks post myomectomy|||cm^2||Standard Deviation|Mean
91509|NCT00891657|Primary|Mean Extent Score of Sites Adherent to the Uterus|0 =no adhesions, 1=covering <25% of locations’ total area, 2=covering 26% to 50% of locations’ total area, and 3=covering >51% of locations’ total area.|8-12 weeks post myomectomy|||Scores on a Scale||Standard Deviation|Mean
91510|NCT00891657|Primary|Mean Severity Score of Sites Adherent to the Uterus|The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.||Scores on a Scale||Standard Deviation|Mean
91511|NCT00891657|Primary|Number of Sites Adherent to the Uterus|The number of times an adhesion is attached to the uterus.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.||Adhesion Sites||Standard Deviation|Mean
91512|NCT00891618|Primary|Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)|Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).|Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.|Participants were excluded from primary outcome if did not complete follow up assessments.||units on a scale||Standard Deviation|Mean
91624|NCT00890201|Secondary|Amylase and Lipase Values in Normal Gallbladders||24 hours||||||
91513|NCT00891462|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)|Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.||L||Standard Error|Least Squares Mean
91514|NCT00891462|Primary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.||L||Standard Error|Least Squares Mean
91515|NCT00891436|Secondary|Histamine Content in the Tears Was Measured.|Tear samples were assayed for histamine by ELISA|Samples taken at initial visit & 2 week follow-up|All participants had tears measured for histamine.||ng/ml||Standard Error|Mean
91516|NCT00891436|Primary|Eosinophilic Cationic Protein (ECP) Levels|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.|Samples taken at initial visit & 2 week follow-up|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.|||||
91517|NCT00891371|Secondary|Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools||Day 56|ITT Population; Missing number of subjects: 1||Percentage of participants|||Number
91518|NCT00891371|Secondary|Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects|Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.|Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1||Percentage of days per Week||Standard Deviation|Mean
91519|NCT00891371|Secondary|Percent Change in Mean Number of Stools Compared to Baseline||Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1||Percent change||Standard Deviation|Mean
91520|NCT00891371|Secondary|Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline|Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid|Baseline (day 1), day 28 and day 56|ITT Population; Missing number of subjects = 1||units on a scale||Full Range|Median
91521|NCT00891371|Secondary|Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline|"SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition~IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL"|Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56|ITT Population, Analysis based on number (n) of patients with a valid value.||units on a scale||Standard Deviation|Mean
91522|NCT00891371|Primary|Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)||Day 28|Intention to Treat (ITT) Population [All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods]||Percentage of patients|||Number
91523|NCT00891293|Secondary|Percent Change in Non-HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91524|NCT00891293|Secondary|Percent Change in Apo B From LOV111859/OM5 (Double-blind [DB[ Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91525|NCT00891293|Secondary|Percent Change in Apo A-1 From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study|Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
92906|NCT00877929|Secondary|Systolic Blood Pressure (SBP) Control 140 at Eight Weeks|Mean seated SBP < 140 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
91526|NCT00891293|Secondary|Percent Change in Ratio of Total-C:HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Ext. Study)|Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91527|NCT00891293|Secondary|Percent Change in HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91528|NCT00891293|Secondary|Percent Change in LDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91529|NCT00891293|Secondary|Percent Change in VLDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91530|NCT00891293|Secondary|Percent Change in Total Cholesterol From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study).|Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91531|NCT00891293|Primary|Percent Change in Serum Triglycerides From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension).|Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|Modified Intent-To-Treat (MITT) Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.||Percentage change||Full Range|Median
91532|NCT00891202|Secondary|Percent Change From Baseline in Platelet Counts at Week 39|Percent change in platelet count = ([platelet count at Week 39 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 39|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.||percent change||Standard Error|Least Squares Mean
91533|NCT00891202|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 39|Percent change in liver volume = ([liver volume at Week 39 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 39|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.||percent change||Standard Error|Least Squares Mean
91534|NCT00891202|Secondary|Absolute Change From Baseline in Hemoglobin Level at Week 39|Absolute change = hemoglobin level at Week 39 minus hemoglobin level at baseline.|Baseline, Week 39|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.||g/dL||Standard Error|Least Squares Mean
91535|NCT00891202|Secondary|Hemoglobin Level||Baseline|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.||gram per deciliter (g/dL)||Standard Deviation|Mean
91536|NCT00891202|Primary|Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo|Percent change in spleen volume = ([spleen volume at Week 39 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 39|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.||percent change||Standard Error|Least Squares Mean
91625|NCT00890201|Primary|Amylase and Lipase Values in Gallbladder Bile|Normal values of lipase and amylase in gallbladder bile should be zero|24 hours|The number of participants analyzed was determined by the number of participants that matched the inclusion criteria. As posted elsewhere some participants were excluded from this analysis based in the exclusion criteria of the protocol.||mg/dl||Standard Deviation|Mean
91537|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age|Analysis was performed on the Total Enrolled cohort at 6 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.||Subjects|||Number
91538|NCT00891176|Secondary|Anti-HBs Antibody Concentrations||At 6 years of age||12/2014||||
91539|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values||At 6 years of age||12/2014||||
91540|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||EL.U/mL||95% Confidence Interval|Geometric Mean
91541|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.|At 6 years of age||12/2014||||
91542|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
91543|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
91544|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||Subjects|||Number
91545|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age||Titer||95% Confidence Interval|Geometric Mean
91546|NCT00891176|Secondary|Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||Subjects|||Number
91547|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age.||Subjects|||Number
91548|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.||Subjects|||Number
91549|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age|Analysis was performed on the Total Enrolled cohort at 4 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.||Subjects|||Number
91550|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||mIU/mL||95% Confidence Interval|Geometric Mean
92907|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
91551|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
91552|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||EL.U/mL||95% Confidence Interval|Geometric Mean
91553|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
91554|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||μg/mL||95% Confidence Interval|Geometric Mean
91555|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||μg/mL||95% Confidence Interval|Geometric Mean
91556|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
91557|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Subjects|||Number
91558|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age||Titers||95% Confidence Interval|Geometric Mean
91559|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age|Analysis was performed on the Total Enrolled cohort at 3 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.||subjects|||Number
91560|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||mIU/mL||95% Confidence Interval|Geometric Mean
91561|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||subjects|||Number
91562|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||EL.U/mL||95% Confidence Interval|Geometric Mean
91563|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age||Subjects|||Number
91564|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|"Antibody concentrations were expressed as GMCs in μg/mL.~Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
91565|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||μg/mL||95% Confidence Interval|Geometric Mean
91566|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||subjects|||Number
91567|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||Titer||95% Confidence Interval|Geometric Mean
91568|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|The cut-off value was defined as a titer equal to or above 1:128.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||subjects|||Number
91569|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.||subjects|||Number
91570|NCT00891020|Secondary|Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24|The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Score on a scale||Standard Deviation|Mean
91571|NCT00891020|Secondary|Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24|The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Score on a scale||Standard Deviation|Mean
91572|NCT00891020|Secondary|Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20|Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient’s benefit-risk after Week 12.|Weeks 12,16, 20|"Safety population includes participants who received at least one dose of study drug. n in each of the categories is the number of participants previously on 4mg/kg + DMARD and receiving a dose at the current visit. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period."||Participants|||Number
91573|NCT00891020|Secondary|Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8|Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.|Baseline, Week 8|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
91574|NCT00891020|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24|"The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:~Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and~At least 3 of the following 5 assessments:~Patient’s global assessment of pain-Visual Analog Scale (VAS)~Patient global assessment of disease activity-(VAS)~Physician global assessment of disease activity-(VAS)~Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)~Acute phase response C-Reactive Protein (CRP)"|Baseline, Weeks 8,16,24|Intent-to-treat population includes all participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received.||Percentage of Participants|||Number
91575|NCT00891020|Secondary|Change From Baseline in DAS28 Score at Weeks 8, 16 and 24|"The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of > 5.1 represents high disease activity.~The Change from Baseline to Weeks 8, 16 and 24 is reported."|Baseline, Weeks 8,16,24|"Intent-to-treat includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Score on a scale||Standard Deviation|Mean
91576|NCT00891020|Secondary|Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24|Clinical Remission is defined as a Disease Activity Score 28 [DAS28] < 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Weeks 8,16,24|"Intent-to-treat population includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."||Percentage of Participants|||Number
91577|NCT00891020|Secondary|Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest|"Non-serious adverse Events of Special interest include:~Serious/Medically Significant Hepatic Events~Spontaneous /Serious Bleeding~Malignant Neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
91578|NCT00891020|Secondary|Percentage of Participants Experiencing Serious Adverse Events of Special Interest|"Serious Adverse Events of Special interest include:~Serious infections including opportunistic infections~Complications of diverticulitis (including lower gastrointestinal [GI] perforations)~Myocardial infarction/acute coronary syndrome~Stroke~Spontaneous or serious bleeding~Malignant neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
91579|NCT00891020|Primary|Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period|"An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above."|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.||Percentage of Participants|||Number
91580|NCT00890981|Secondary|Actual Value of Procollagen Type 1 N-terminal Peptide|Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.||µg/L||95% Confidence Interval|Least Squares Mean
91581|NCT00890981|Secondary|Actual Value of Serum Type I C-telopeptide|Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.||ng/mL||95% Confidence Interval|Least Squares Mean
91582|NCT00890981|Secondary|Percent Change of Total Radius BMD From the Parent Study Baseline by DXA|Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91583|NCT00890981|Secondary|Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA|Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91584|NCT00890981|Secondary|Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA|Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91585|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
92908|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
91586|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91587|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91588|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91589|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91590|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91591|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91592|NCT00890981|Primary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.||Percent change||95% Confidence Interval|Least Squares Mean
91593|NCT00890929|Secondary|OS of Responders|OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)|||weeks||Full Range|Median
91594|NCT00890929|Secondary|Time to PR|Responses were assessed according to the ELN guidelines.|36 weeks|||weeks||Full Range|Median
91595|NCT00890929|Secondary|Time to CR|CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.|18 weeks|||weeks||Full Range|Median
91596|NCT00890929|Secondary|Overall Survival (OS)|OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)|||weeks||Full Range|Median
91597|NCT00890929|Secondary|Overall Response Rate (ORR)|ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.|26 months|||percentage of subjects|||Number
91598|NCT00890929|Secondary|Remission Duration|Responses and remission were assessed according to the ELN guidelines.|26 months|||weeks||Full Range|Median
91599|NCT00890929|Secondary|Maximum Tolerated Dose (MTD) of Lenalidomide|The MTD of lenalidomide was determined in study phase I, for use in study Phase II.|15 months|||mg/day lenalidomide (oral)|||Number
91600|NCT00890929|Secondary|4-week Survival Rate|"Early death was assessed as death within 28 days of the start of treatment"|28 days|||percentage of subjects remaining alive|||Number
91601|NCT00890929|Primary|Compete Remission (CR) Rate|CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the European LeukemiaNet (ELN) guidelines.|12 months|||percentage of subjects|||Number
91602|NCT00890916|Primary|Grasp Release Test - Test of Functional Ability to Pick up and Move Objects|Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.|6-9 weeks|||Number of Completions||Full Range|Median
91603|NCT00890721|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||30 days||||||
92909|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
91604|NCT00890721|Primary|The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo.|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond to the following question: “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?”|72 hours|||units on a scale*hr||Standard Error|Least Squares Mean
91605|NCT00890695|Secondary|Hospital Admission or Death||from enrolment to 3 months|All participants recruited until trial halted||participants|||Number
91606|NCT00890695|Secondary|Anemia (Hb <9.3g/dl)||at 4 weeks|All participants recruited until trial halted||participants|||Number
91607|NCT00890695|Secondary|Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)||at 4 weeks and 3 months|All participants recruited until trial halted||participants|||Number
91608|NCT00890695|Secondary|MUAC for Age Z Score at 3 Months||between enrolment and 4 weeks and at 3 months|All participants recruited until trial halted||Z score||95% Confidence Interval|Mean
91609|NCT00890695|Secondary|WHZ Score at 3 Months||between enrolment and 3 months|All participants recruited until trial halted||Z scores||95% Confidence Interval|Mean
91610|NCT00890695|Primary|Weight for Height z Score at 4 Weeks|"The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition.~A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ<-2 and <-3 respectively. These correspond to 2 and 3 standard deviations below the reference median.~Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines."|between enrolment and 4 weeks|All participants recruited until trial was halted||units on a scale||95% Confidence Interval|Mean
91611|NCT00890682|Secondary|Adverse Event Profile|Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days|30 days||||||
91612|NCT00890682|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|"The AUC of the NRS-R pain intensity scores from time 0 through 24 hours~The subject was to rest for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?”"|0-24 hours|||Units on a scale*hours||Standard Error|Geometric Mean
91613|NCT00890656|Primary|Number of Participants With Complete Remission|Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 * 10^9/L and a platelet count of ≥ 100 * 10^9/L with complete resolution of all sites of extramedullary disease required.|Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.|||Participants|||Number
91614|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)|Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.|4 - 9 weeks|32 subjects started the third and final titration regimen and 12 met their blood pressure goals. 20 dropped out for lack of efficacy.||Participants|||Number
91615|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.|4 to 9 weeks|73 patients started the second titration regimen and 41 met their blood pressure goal. There were no dropouts. 32 started the final titration regimen.||Participants|||Number
91616|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks|4 to 9 weeks on combination therapy|In this first titration group 106 patients started and 33 achieved their blood pressure goal. There were no dropouts and 73 subject started the second titration regimen.||Participants|||Number
91617|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)|Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level|4 - 9 wks of olmesartan monotherapy|In this first dosage group 144 started and 38 patients met their blood pressure goal; therefore, 106 started the first titration regimen. There were no dropouts.||Participants|||Number
91618|NCT00890409|Secondary|Major Adverse Events|Major adverse events were defined as severe arrhythmia (II or III degree A-V block or atrial or ventricular arrhythmia), major venous thrombosis, refractory hypotension (mean blood pressure less than 40 mmHg), moderate or severe scleredema (greater or equal to 20% body surface area), and severe bleeding.|18 months|||participants|||Number
91619|NCT00890409|Primary|Severe Neurodevelopmental Disability|Severe disability was defined as cerebral palsy (CP) or mental retardation (MR). The definition of MR was development quotient (DQ) <70 by Gesell’s Child Development Scale and CP was based on the Criteria of a level 3 to 5 by the Gross Motor Function Classification System (GMFCS).|18 months|||participants|||Number
91620|NCT00890409|Primary|Death|The number of deaths by 18 months of age.|18 months|||participants|||Number
91621|NCT00890201|Secondary|Normal Preoperative Serum Values of Amylase and Lipase||24 hours||||||
91622|NCT00890201|Secondary|Normal Operative Cholangiography||24 hours||||||
91623|NCT00890201|Secondary|Amylase and Lipase Values in Gallbladders With Cholelithiasis||24 hours||||||
91626|NCT00890097|Primary|Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging|The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.|Baseline, up to Month 30|This analysis population included all treated subjects. A subject was considered treated if they had a first or last dosing date in the database.||square millimeters per year||95% Confidence Interval|Mean
91627|NCT00890084|Secondary|Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007|Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients|12 weeks|all investigators participating in the trial||percentage of prescribers||95% Confidence Interval|Number
91628|NCT00890084|Secondary|Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg||12 weeks|Intention to treat (ITT)||percentage of patients||95% Confidence Interval|Number
91629|NCT00890084|Secondary|Change in Concomitant Antihypertensive Drugs Given at Study Entry|Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.|baseline and 12 weeks|Intention to treat (ITT)||percentage of patients||95% Confidence Interval|Number
91630|NCT00890084|Secondary|Treatment Patterns|Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).|12 weeks|ITT Population||Percentage of patients|||Number
91631|NCT00890084|Secondary|BP Response Rate (Drop of Systolic BP of 10mmHg or More)|BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)|12 weeks|ITT Population||Percentage of patients||95% Confidence Interval|Number
91632|NCT00890084|Secondary|Absolute Blood Pressure Decrease|systolic blood pressure|baseline and 12 weeks|Intention to treat (ITT)||mm Hg||95% Confidence Interval|Mean
91633|NCT00890084|Secondary|Percentage of Patients With Blood Pressure < 130/80 mm Hg||12 weeks|Intention to Treat (ITT)||Percentage of participants||95% Confidence Interval|Number
91634|NCT00890084|Primary|Percentage of Patients With Blood Pressure < 140/90 mm Hg|% of high risk patients with Blood Pressure < 140/90 mm Hg|12 weeks|Intention-to-Treat (ITT)||Percentage of participants||95% Confidence Interval|Number
91635|NCT00889928|Primary|Procedure Completion|Completion of procedure - transvaginal removal of the gallbladder|Day of Surgery|All subjects on whom the procedure was attempted.||participants|||Number
91636|NCT00889915|Secondary|Clinical Global Improvements-Acceptability (CGI-A) Scale|The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability|Measured at each participant's last visit, which can occur at or before Week 6|||Units on a scale||Full Range|Median
91637|NCT00889915|Secondary|Clinical Global Impressions-Improvement (CGI-I) Scale|The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse.|Measured at each participant's last visit, which can occur at or before Week 6|||Units on a scale||Full Range|Median
91638|NCT00889915|Primary|Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale|The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.|Measured at each participant's last visit, which can occur at or before Week 6|||Units on a scale||Full Range|Median
91639|NCT00889863|Secondary|Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact–emotional, Parental impact–time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates.|Start Part II (Week 32), End Part II (total duration - 88 Weeks)|Full Analysis Set Part II-patients aged 5-18 years.||Score on a scale||Standard Error|Least Squares Mean
91652|NCT00889824|Primary|Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.|The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.|6 weeks|The Dynamic Gait Index (DGI) data were analyzed by way of an linear mixed (LM) model. The DGI response data were treated as the dependent observations.||units on a scale||Standard Deviation|Mean
94469|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 2|SBP < 140 mmHg and DBP < 90 mmHg|week 2|FAS (LOCF)||participants|||Number
91640|NCT00889863|Secondary|Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: Physical functioning, Role/social emotional, Role/social behavior, Role/social physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact – emotional, Parental impact – time, Family activities, and Family cohesion. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement.|Baseline, End of Part I ( Week 32)|Participants from the Full Analysis Set Part I-age 5 to 18 years.||Score on a scale||Full Range|Median
91641|NCT00889863|Secondary|Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI)|"CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do).~Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates."|Start of Part II (Week 32), End of Part II ( total duration-88 weeks)|Full Analysis set Part II.||Score on a scale||Standard Error|Least Squares Mean
91642|NCT00889863|Secondary|Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I|The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement.|Baseline, End of Part I (Week 32)|Participants from the Full Analysis Set Part I with data at baseline and End of Part I.||Score on a scale||Full Range|Median
91643|NCT00889863|Secondary|Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response|"Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response.~ACR response is determined by the following items:~Physician’s global assessment of disease activity~CHAQ-patient’s overall wellbeing~CHAQ-Functional ability~Number of joints with active arthritis~Number of joints with limitation of motion~C-Reactive Protein.~No intermittent fever in the preceding week"|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set Part II||Days||95% Confidence Interval|Median
91644|NCT00889863|Secondary|Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a||Day 3|Participants from the Full Analysis Set Part I with temperature readings at Day 3.||Percentage of participants||95% Confidence Interval|Number
91645|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 70 and a Normal CRP.||Days||Standard Deviation|Mean
91646|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP.||Days||Standard Deviation|Mean
91647|NCT00889863|Secondary|Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I|"Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following:~improvement from baseline of ≥ 30%, ≥ 50%, ≥ 70%, ≥ 90%, or 100%, in at least 3 of the first 6 response variables~Physician’s global assessment of disease activity~CHAQ-patient’s overall well-being~CHAQ-Functional ability~# of joints with active arthritis~# of joints with limitation of motion~C-Reactive Protein.~no intermittent fever in the preceding week~no more than one of the first 6 response variables worsening by more than 30%"|Baseline, 32 Weeks|Participants from the full analysis set with an assessment at the given time-point.||Percentage of participants|||Number
91648|NCT00889863|Secondary|Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c||Start of Part Ic (After Week 8) to End of Part Ic (Week 28)|Participants from the Full Analysis set who were taking oral steroids at the start of Part Ic.||Percentage of participants||90% Confidence Interval|Number
91649|NCT00889863|Secondary|Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic||28 Weeks|Participants from the Full Analysis set who were taking oral steroids at the start of the study.||Percentage of participants||95% Confidence Interval|Number
91650|NCT00889863|Primary|Part II: Survival Estimate of Time to Flare|"Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following.~Reappearance of fever (>38°C, lasting for at least 2 consecutive days) not due to infections~Flare according to the JIA pediatric criteria for flare (all criteria must have been met):~≥ 30% worsening in at least 3 of the first 6 response variables~≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II."|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set in Part II||Days||95% Confidence Interval|Median
91651|NCT00889863|Primary|Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid|Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures.|32 Weeks|Participants from the Full Analysis Set who were taking oral steroids at the beginning of Part I.||Percentage of participants||90% Confidence Interval|Number
92910|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
91653|NCT00889720|Secondary|Number of Treatment Emergent Adverse Events by Severity|Mild: did not interfere with usual function; Moderate: interfered to some extent with usual function; Severe: interfered significantly with usual function. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence was taken. Missing baseline severities were imputed as mild.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.||events|||Number
91654|NCT00889720|Secondary|Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline|Treatment-emergent AE (TEAE): any untoward medical occurrence that occurred or worsened after beginning study treatment without regard to causal relationship. Treatment-related TEAE: investigator assessment of reasonable possibility that treatment caused or contributed to AE. Severe TEAE: interfered significantly with usual function. SAE: AE resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience (immediate risk of death), persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set: participants who took at least 1 dose (including partial doses) of study medication. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.||participants|||Number
91655|NCT00889720|Secondary|Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline.||Baseline, Week 12, Week 26|Surgical population: Not analyzed due the limited number of participants recruited.||percentage of participants|||Number
91656|NCT00889720|Secondary|Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|Week 26|Surgical population: N = number of participants who had a Week 26 visit.||participants|||Number
91657|NCT00889720|Secondary|Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|Week 12|Surgical population: N = number of participants who had a Week 12 visit.||participants|||Number
91658|NCT00889720|Secondary|Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline.||Baseline, Week 8|Surgical population. Not analyzed due the limited number of participants recruited.||percentage of participants|||Number
91659|NCT00889720|Secondary|Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System|Grade 0: no post-operative (post-op) complications (comp), Grade 1: any deviation from normal post-op course without need for pharmacological treatment (PT) other than allowed interventions (INT), or surgical, endoscopic or radiological INT; Grade II: required PT with drugs other than those allowed for grade I comp; Grade III required surgical, endoscopic or radiological INT, IIIa: not under general anaesthesia (GA), IIIb: under GA; Grade IV: life-threatening comp requiring IC/ICU management, IVa: single organ dysfunction (DSF), IVb: multiorgan DSF; Grade V: death. Not done = not assessed.|Baseline through Week 26|Surgical Population; N = participants who took at least 1 dose of study medication and received planned surgery. Results provided for participants who had a study visit at timepoint. For participants with more than 1 incidence of surgical complication recorded, the most severe incidence was used for analysis. Abbreviations: PS=post-surgery.||participants|||Number
91660|NCT00889720|Primary|Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)|Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery.||participants|||Number
91661|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 26|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 26|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit.||participants|||Number
91662|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 12|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 12|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit.||participants|||Number
91663|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit.||participants|||Number
92911|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
91664|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit.||participants|||Number
91665|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.||participants|||Number
91666|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.||participants|||Number
91667|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.||participants|||Number
91668|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.||participants|||Number
91669|NCT00889720|Primary|Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection|Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.|Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26|Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken.||participants|||Number
91670|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.||participants|||Number
91671|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.||participants|||Number
91672|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.||participants|||Number
91687|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS. N=number of participants with evaluable data.||Participants|||Number
91673|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.||participants|||Number
91674|NCT00889720|Primary|Percentage of Fully Compliant Participants|Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery.|Baseline through Week 12|Surgical Population: subset of Full Analysis Set; includes all participants who took at least 1 dose (including partial doses) of study medication and received their planned surgery within the study period. N = participants in surgical population.||percentage of participants|||Number
91675|NCT00889707|Secondary|Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)|A printout of uroflowmetry was provided to a central, blinded, independent reviewer for determination of the Qmax values to be used for evaluation of efficacy. The central, independent, blinded reviewer determined the Qmax from over-reads of the uroflowmetry printouts, applying the 2-second rule to reduce variability and increase the accuracy.|3 months after treatment|The protocol-defined efficacy evaluable (EE) primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel||ml/sec||Standard Deviation|Mean
91676|NCT00889707|Primary|Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)|Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.|3 months post-treatment|The efficacy evaluable (EE) protocol defined primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel.||score||Standard Deviation|Mean
91677|NCT00889681|Primary|Long-term Clinical Success|Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|180 days|78 of 81 subjects were treated with cryoablation.||Participants|||Number
91678|NCT00889681|Primary|Freedom From Major Atrial Fibrillation Events (MAFE)|Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.|365 days|78 of 81 enrolled subjects were treated with cryoablation.||Participants|||Number
91679|NCT00889681|Primary|Acute Procedural Success (APS)|Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.|At the conclusion of the cryoablation procedure|78 of 81 subjects were treated with cryoablation.||Participants|||Number
91680|NCT00889681|Primary|Cryoablation Procedure Events (CPEs)|Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.|365 days|78 of the 81 enrolled subjects were treated with cryoablation.||Participants|||Number
91681|NCT00889603|Other Pre-specified|Number of Participants Receiving Other Medications|Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.|Baseline and Week 24|Safety population||Participants|||Number
91682|NCT00889603|Other Pre-specified|Number of Participants With Treatment Tolerability|Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor|Week 24|Safety population; N=number of particpants with evaluable data.||Participants|||Number
91683|NCT00889603|Secondary|Number of Participants in Each Patient Domain of Benefit|Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated ‘yes’ and leaving a box blank indicated ‘no’).|Week 24|Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24.||Participants|||Number
91684|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS; LOCF. N=number of participants with evaluable data.||Participants|||Number
91685|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS. N=number of participants with evaluable data.||Participants|||Number
91686|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 16|FAS. N=number of participants with evaluable data.||Participants|||Number
91688|NCT00889603|Secondary|Change From Baseline in Functional Activity Questionnaire (FAQ)|Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.|Baseline and Week 24|FAS. Data not analyzed||Scores on a scale||Standard Deviation|Mean
91689|NCT00889603|Secondary|Change From Baseline in MMSE Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.|Baseline, Week 8, 16, and 24|FAS. N=number of participants with evaluable data.||Scores on a scale||Standard Error|Least Squares Mean
91690|NCT00889603|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.|Baseline and Week 24|Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data.||Scores on a scale||Standard Error|Mean
91691|NCT00889512|Secondary|Secondary Outcomes Include Pregnancy Rates, Number of Follicles, Hormone Levels on the Day of hCG, Days of GnRH Antagonist, Fertilization and Implantation Rates.||3 years||||||
91692|NCT00889512|Primary|The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG.||2 years|||number of follicles||Full Range|Median
91693|NCT00889421|Secondary|Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment||7 months||||||
91694|NCT00889421|Primary|Reduction in Cystoid Macular Edema||6 months||||||
91695|NCT00889421|Primary|Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)||6 months||||||
91696|NCT00889421|Primary|Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%||6 months||||||
91697|NCT00889421|Primary|Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye||6 months||||||
91698|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) post-dose, pre-allergen challenge|||eyes|Participants||Number
91699|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) pre-dose, pre-allergen challenge|||eyes|Participants||Number
91700|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) post-dose, pre-allergen challenge|||eyes|Participants||Number
91701|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) pre-dose, pre-allergen challenge|||eyes|Participants||Number
91702|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 2 (Day -14) pre-allergen challenge|||eyes|Participants||Number
91703|NCT00889330|Other Pre-specified|Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14|The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve|Visit 4 (Day 14) pre-dose, pre-allergen challenge|||eyes|Participants||Number
91704|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 4 (Day 14) pre-dose, pre-allergen challenge|||eyes|Participants||Number
91705|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 3 (Day 0) pre-dose, pre-allergen challenge|||eyes|Participants||Number
91706|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14|The number of eyes with any change in visual acuity measurements compared to Day -21.|Visit 2 (Day -14) pre-allergen challenge|||eyes|Participants||Number
91707|NCT00889330|Primary|Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 4 (Day 14) At 20 minutes following Allergen Challenge|||units on a scale||Standard Deviation|Mean
91708|NCT00889330|Primary|Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation|"0 to 4 scale, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub"|Visit 4 (Day 14) up to 7 minutes following Allergen Challenge|||units on a scale||Standard Deviation|Mean
91709|NCT00889330|Primary|Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment|||units on a scale||Standard Deviation|Mean
91710|NCT00889330|Primary|Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.|"A 0 to 4 scale used, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge|||units on a scale||Standard Deviation|Mean
91711|NCT00889265|Secondary|Mean Wound Healing Index at 6 Months|"Score Description~Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence~Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration~Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration"|6 months|||units on a scale||Standard Deviation|Mean
91712|NCT00889265|Primary|Change in Horizontal Ridge Widths From Baseline to 6 Months|The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.|6 months|||mm||Standard Deviation|Mean
91713|NCT00889252|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at the 12 week visit|Subjects that completed the study per protocol were included in this analysis.||Eyes|Participants||Number
91714|NCT00889252|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91715|NCT00889252|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91716|NCT00889252|Primary|Intraocular Pressure - Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||mm of mercury|Participants|Standard Deviation|Mean
91717|NCT00889252|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, the central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91718|NCT00889252|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, the upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91719|NCT00889252|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91720|NCT00889252|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91721|NCT00889252|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91722|NCT00889252|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91723|NCT00889252|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91724|NCT00889252|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91725|NCT00889252|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91726|NCT00889252|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91727|NCT00889252|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91728|NCT00889252|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91729|NCT00889252|Primary|Conjunctival Redness, Change From Baseline|Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91730|NCT00889252|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91731|NCT00889252|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
91732|NCT00889200|Primary|Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)|Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).|post drug (6 weeks oral eszopiclone)|All subjects completed all study procedures||nmol/L|Participants|Standard Deviation|Mean
91733|NCT00888979|Secondary|Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.||Baseline to 4 weeks|||reduction in number of CPD||Standard Deviation|Mean
91734|NCT00888979|Secondary|Cartridge Use||Baseline to 4 weeks|||cartridges per day||Standard Deviation|Mean
91735|NCT00888979|Primary|Number of Days of Inhaler Use||Baseline to 4 weeks|||days||Standard Deviation|Mean
91736|NCT00888940|Secondary|Treatment-emergent Adverse Events.||Over the duration of the study.|Safety population analyzed||events|||Number
91737|NCT00888940|Primary|Cumulative Volume of Packed Red Blood Cells Transfused||12 hours after the end of surgery|Modified Intent to Treat = all subjects received at least one dose and analyzed according to planned treatment assignment. 3 subjects in ecallantide group not included due to no value being present||mL||Standard Deviation|Mean
91738|NCT00888849|Primary|Return to Bowel Activity||Number of days post-surgery to appearance of peristaltic movement|||days||Standard Error|Mean
91739|NCT00888849|Primary|Time of Anastomosis||Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)|||minutes||Standard Error|Mean
91740|NCT00888849|Primary|Time of Surgery (Skin Open to Skin Close)||Day 1|Intent-to-Treat||minutes||Standard Error|Mean
91741|NCT00888654|Secondary|Levels of Androgen Receptor, NF-kB, and PSA in Prostate Tissue||Pre and post radical prostatectomy||||||
91742|NCT00888654|Secondary|Serum Levels of PSA, Testosterone,DIM Level and Diindolylmethane||Pre and post radical prostatectomy||||||
91743|NCT00888654|Primary|Mean Level of Diindolylmethane in Prostate Tissue After Treatment||Within the first 24 months after radical prostatectomy.|Patients that were eligible, evaluable, and compliant||ng/g||90% Confidence Interval|Mean
91744|NCT00888628|Secondary|Measures of Metabolic Control||1 year after the subject's first islet transplant||||||
91745|NCT00888628|Secondary|Renal Impact Measures Including Renal Allograft Survival||1 year after the subject's first islet transplant||||||
91746|NCT00888628|Secondary|Impact on Vision||1 year after the subject's first islet transplant||||||
91747|NCT00888628|Secondary|Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction||1 year after the subject's first islet transplant||01/2017||||
91748|NCT00888628|Secondary|Urinary Albumin and Creatinine Ratio and Serum Creatinine||1 year after subjects initial islet transplant||||||
91749|NCT00888628|Secondary|HbA1c and Number of Hypoglycemic Events||1 year after subject's first islet transplant||||||
91750|NCT00888628|Primary|Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.||1 year after the subject's first islet transplant|||participants|||Number
91751|NCT00888459|Primary|Number of Participants With Tobacco Abstinence|self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)|12 weeks|intention to treat||participants|||Number
91752|NCT00888433|Primary|Office Systolic Blood Pressure Reduction|The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.|Baseline to 6 months|||mmHg||Standard Deviation|Mean
91753|NCT00888381|Secondary|The Incidence of Any Unsolicited Adverse Events (AEs).|"The number of participants reporting any unsolicited adverse events.~Unsolicited adverse event (UAE) grading:~Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine.||participants|||Number
91754|NCT00888381|Secondary|The Frequency of Any Solicited Systemic Symptoms.|The number of participants reporting any solicited systemic symptoms.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.||participants|||Number
91755|NCT00888381|Secondary|The Frequency of Any Solicited Local Reactions.|The number of participants reporting any solicited local reactions.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.||participants|||Number
91756|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||percentage of participants||95% Confidence Interval|Number
92912|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
91757|NCT00888381|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||percentage of participants||95% Confidence Interval|Number
91758|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).||percentage of participants||95% Confidence Interval|Number
91759|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to LAEs|Patients discontinued due to LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis||Participants|||Number
91760|NCT00888355|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
91761|NCT00888355|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
91762|NCT00888355|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
91763|NCT00888355|Other Pre-specified|Number of Patients Who Died|Patients who died during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
91764|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to CAEs|Patients discontinued due to CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
91765|NCT00888355|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
91766|NCT00888355|Other Pre-specified|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
91767|NCT00888355|Other Pre-specified|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
91768|NCT00888355|Secondary|Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III.|24 hours after last morning dose and 12 hours after last PM dose at 12 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
91769|NCT00888355|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours after last morning dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
91770|NCT00888355|Secondary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
91807|NCT00887965|Secondary|Bone Histomorphometry: Double-label Surface|Double-label surface is expressed as a percentage of total bone surface. The presence of double labels indicates that normal bone mineralization was actively occurring over the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
91771|NCT00888355|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
91772|NCT00888329|Primary|Number of Participants With Emesis|This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.|24 hours after emergence from anesthesia|ITT. However, the primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group.||participants|||Number
91773|NCT00888238|Secondary|Glucose Infusion Rate (GIR) During 190 – 340 Minutes Post-dose|Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.||mg / kg / min||Standard Deviation|Least Squares Mean
91774|NCT00888238|Primary|Insulin Secretion Rate (ISR) During 190 – 340 Minutes Post-dose|ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.||ng/min||Standard Deviation|Least Squares Mean
91775|NCT00888134|Secondary|Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip||Up to 4 years|Samples and data were not collected for this outcome.|||||
91776|NCT00888134|Secondary|Progression-free Survival|Reported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.|4 months|||percentage of participants||95% Confidence Interval|Number
91777|NCT00888134|Secondary|Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers|Percentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.|Up to 4 years|||percentage of participants|||Number
91778|NCT00888134|Secondary|AKT Pathway Activity|Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)|Up to 4 years|Samples and data were not collected for this outcome.|||||
91779|NCT00888134|Primary|Objective Response Rate in Patients With Cancers Other Than Melanoma|Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).|4 years|||percentage of participants|||Number
91780|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 3.6 - 26.4 Years||Baseline and 16 weeks|Subjects who had been diagnosed with PAH for 3.6 to 26.4 years prior to Baseline.||meters||Inter-Quartile Range|Median
91781|NCT00887978|Post-Hoc|6-minute Walk Distance by Years Since PAH Diagnosis: 1.8 - 3.5 Years||Baseline and 16 weeks|Subjects who were diagnosed with PAH between 1.8 and 3.5 years prior to Baseline.||meter||Inter-Quartile Range|Median
91782|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 0.9 - 1.74 Years||16 Weeks|Subjects who had been diagnosed with PAH between 0.9 and 1.74 years prior to Baseline.||meters||Inter-Quartile Range|Median
91783|NCT00887978|Post-Hoc|6-minute Walk Distance by Time to PAH Diagnosis: 0 - 0.9 Years||Baseline and 16 weeks|Subjects who have been diagnosed with PAH between 0 to 0.9 years prior to Baseline.||meters||Inter-Quartile Range|Median
91784|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA + PDE-5i||16 weeks|Subjects receiving both an ERA and a PDE-5i at Baseline.||meters||Inter-Quartile Range|Median
91785|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA Only||Baseline and 16 weeks|Subjects who were only receiving an ERA at Baseline||meters||Inter-Quartile Range|Median
91786|NCT00887978|Post-Hoc|6-minute Walk Distance by Background PAH Therapy: PDE-5i Only||16 weeks|Subjects receiving only a PDE-5i at Baseline||meters||Inter-Quartile Range|Median
91787|NCT00887978|Post-Hoc|6-minute Walk Distance by PAH Etiology: Idiopathic PAH (IPAH) / Heritable PAH(HPAH)|Covariate analysis of change in 6MWD by PAH etiology, specifically idiopathic or heritable PAH|Baseline and 16 Weeks|Subjects with IPAH/HPAH||meters||Inter-Quartile Range|Median
91788|NCT00887978|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 16. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 16 Weeks|Subjects in countries where the CAMPHOR has not been validated in the local language were not included in these analyses. Additionally, only subjects with completed questionnaires at Baseline and Week 16 were analyzed.||units on a scale||Inter-Quartile Range|Median
91789|NCT00887978|Secondary|N-terminal proBNP (NT-proBNP)|Serum N-terminal pro-BNP concentration was assessed at Baseline and Week 16.|Baseline and 16 Weeks|Subjects who were missing Week 16 samples were not included in the analysis.||pg/mL||Standard Deviation|Mean
91790|NCT00887978|Secondary|Dyspnea Fatigue Index|The dyspnea-fatigue index was assessed at Baseline and Week 16. Each of the three components of the dyspnea-fatigue index were rated on a scale 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.|Baseline and 16 Weeks|Subjects without a Dyspnea Fatigue Index score at Baseline were not included in the analysis.||units on a scale||Standard Deviation|Mean
92913|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
91791|NCT00887978|Secondary|Symptoms of PAH|Symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed by the physician at Baseline and Week 16. Severity grade values (i.e., 0, 1, 2 or 3) for each symptom were provided each subject. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Mean change in symptom severity from Baseline to Week 16 is described.|Baseline and 16 Weeks|Subjects without Baseline assessments of PAH symptoms were not included in the analysis.||units on a scale||Standard Deviation|Mean
91792|NCT00887978|Secondary|World Health Organization (WHO) Functional Class|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and 16 Weeks|Subjects with a WHO functional class assessment at Week 16||participants|||Number
91793|NCT00887978|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and 16 Weeks|All subjects with a Baseline Borg Score were included in the analysis. One subject in the placebo group did not have a Baseline Borg Score recorded.||score||Inter-Quartile Range|Median
91794|NCT00887978|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 16 weeks of study:~Death (all causes excluding accident)~Transplantation~Atrial septostomy~Hospitalization as a result of right heart failure~Greater than or equal to a 20% decrease in 6MWD from Baseline (or too ill to walk) AND addition of an inhaled prostacyclin analogue, ERA, or PDE-5i~Initiation of parenteral prostacyclin therapy (i.e., epoprostenol, iloprost, or treprostinil) for the treatment of PAH"|Baseline and 16 Weeks|Intention to treat analysis||number of clinical worsening events|||Number
91795|NCT00887978|Primary|6-minute Walk Distance (6MWD)|"Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies)."|Baseline and 16 weeks|Intention to treat analysis||meters||Inter-Quartile Range|Median
91796|NCT00887965|Secondary|Procollagen Type 1 N-terminal Peptide (P1NP)|Procollagen Type 1 N-terminal Peptide is a biochemical marker of bone turnover. Blood samples were drawn for assessment of P1NP levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy||μg/L||Inter-Quartile Range|Median
91797|NCT00887965|Secondary|C-Telopeptide (CTX-1)|C-Telopeptide is a biochemical marker for bone turnover. Blood samples were drawn for assessment of CTX-1 levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy||ng/mL||Inter-Quartile Range|Median
91798|NCT00887965|Secondary|Bone Histomorphometry: Mineralization Lag Time|The mineralization lag time is the time interval between osteoid secretion and its subsequent mineralization, in days.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||days||Inter-Quartile Range|Median
91799|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Volume|Osteoid volume is expressed as a percentage of total bone volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of total volume||Inter-Quartile Range|Median
91800|NCT00887965|Secondary|Bone Histomorphometry: Activation Frequency|The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency (Ac.f). Activation frequency is calculated as the bone formation rate / wall width.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||/year||Inter-Quartile Range|Median
91801|NCT00887965|Secondary|Bone Histomorphometry: Formation Period|The formation period is the duration of an interval when a place on the bone surface is actively forming bone. The formation period is calculated as the wall width (thickness of new bone made in one cycle) divided by the mineral apposition rate.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||days||Inter-Quartile Range|Median
91802|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Volume Based|Bone formation rate - volume based (BFR/BV) is the calculated rate at which cancellous bone volume is being replaced annually. BFR/BV is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percent of bone volume per year||Inter-Quartile Range|Median
91803|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Surface Based|Bone formation rate - surface based (BFR/BS) is the calculated rate at which cancellous bone surface is being replaced annually. BFR/BS is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface /total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm^3 /μm^2 /year||Inter-Quartile Range|Median
91804|NCT00887965|Secondary|Bone Histomorphometry: Adjusted Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm/day||Inter-Quartile Range|Median
91805|NCT00887965|Secondary|Bone Histomorphometry: Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm/day||Inter-Quartile Range|Median
91806|NCT00887965|Secondary|Bone Histomorphometry: Total Mineralizing Surface|Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
92914|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
91808|NCT00887965|Secondary|Bone Histomorphometry: Single-label Surface|Single-label surface is expressed as a percentage of total bone surface. The presence of a single label indicates that mineralization was occurring during only one labeling period.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
91809|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Surface Based|Osteoclast number expressed per bone surface area. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||1/100 mm||Inter-Quartile Range|Median
91810|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Length Based|Osteoclast number expressed per mm of bone. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||1/mm||Inter-Quartile Range|Median
91811|NCT00887965|Secondary|Bone Histomorphometry: Eroded Surface/Bone Surface|Eroded surface is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
91812|NCT00887965|Secondary|Bone Histomorphometry: Wall Thickness|Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
91813|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Width|Osteoid thickness (width; O.Th) is the mean thickness of osteoid seams on cancellous surfaces. O.Th is normally <12.5 µm. Increased O.Th suggests abnormal mineralization (osteomalacia).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
91814|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Surface|Osteoid surface is expressed as a percentage total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of bone surface||Inter-Quartile Range|Median
91815|NCT00887965|Secondary|Bone Histomorphometry: Osteoblast - Osteoid Interface|Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||percentage of osteoid surface||Inter-Quartile Range|Median
91816|NCT00887965|Secondary|Bone Histomorphometry: Surface Density|Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||mm^2 /mm^3||Inter-Quartile Range|Median
91817|NCT00887965|Secondary|Bone Histomorphometry: Cortical Width|Cortical width correlates with dual photon absorptiometric (DPX) measurements of bone density.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
91818|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Thickness|Mean trabecular thickness (Tb.Th) is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Tb.Th is reduced by aging and osteoporosis.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
91819|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Separation|Trabecular separation (Tb.Sp) is the mean distance in mm between trabeculae (measured by integrated computer graphics). Tb.Sp increases with trabecular bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||μm||Inter-Quartile Range|Median
91820|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Number|Trabecular number (Tb.N) is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Tb.N is a measure of trabecular connectivity and decreases with bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.||mm^-1||Inter-Quartile Range|Median
91821|NCT00887965|Secondary|Bone Histomorphometry: Cancellous Bone Volume|Cancellous (trabecular) bone volume (Tb.V) is the relative volume of total cancellous bone measured (TV), expressed as percentage, that is occupied by trabeculae. Cancellous bone volume was measured using Fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry||percentage of total volume||Inter-Quartile Range|Median
91822|NCT00887965|Primary|Number of Participants With Normal/Abnormal Bone Histology|The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.|25-34 days post-Day 1|All enrolled patients who had at least one evaluable biopsy||Participants|||Number
91823|NCT00887913|Primary|Improvement in Brightness|"Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up post last treatment|Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0.||Scores on a scale|Participants|Standard Deviation|Mean
91824|NCT00887913|Primary|Improvement in Smoothness|"Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 weeks follow up post last treatment|Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin||Scores on a scale|Participants|Standard Deviation|Mean
91825|NCT00887913|Primary|Improvement in Fine Lines|"Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up after last treatment|Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4||Scores on a scale|Participants|Standard Deviation|Mean
91828|NCT00887744|Secondary|Mean Change in Quality of Life Score at 12 Months Compared to Baseline|The quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored.|From baseline up to 12 months follow up|||Scores on a scale (1-100)||Standard Deviation|Mean
91829|NCT00887744|Secondary|Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire|"The Zurich Claudication Questionnaire – Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0.~The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months|||Percent Change||Standard Deviation|Mean
91830|NCT00887744|Secondary|Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|"The Zurich Claudication questionnaire - Symptom Severity score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5.~The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months follow up|||Percent Change||Standard Deviation|Mean
91831|NCT00887744|Primary|The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure|"Adverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed:~Day of the procedure until P+1 (where P refers to the day of the surgical procedure)~P+2 until P+7"|Starting at the surgical procedure till 7 days post-operatively|||Proportion of patients (%)|||Number
91832|NCT00887744|Primary|Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.|From baseline up to 6 weeks follow-up|Intention-To-Treat: the population of patients who underwent the minimally invasive procedure.||Percent change||Standard Deviation|Mean
91833|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)|"Scoring:~Participants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant."|baseline and 7 weeks|||units on a scale||Standard Deviation|Mean
91834|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)|Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.|baseline and 7 weeks|||units on a scale||Standard Deviation|Mean
91835|NCT00887679|Secondary|Change From Randomization to End of Treatment for Trail Making Tet (TMT)|"Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.~Average =29 seconds, Deficient > 78 seconds"|baseline to 7 weeks|||seconds||Standard Deviation|Mean
91836|NCT00887679|Secondary|Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)|"Scale for scoring:~Clinical Global Impression(CGI-S)~= Normal, no symptoms~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Most extremely ill~Clinical Global Impression(CGI-I)-improvement since treatment~very much improved~much improved~minimally improved~no change from baseline~minimally worse~much worse~very much worse"|baseline and 7 weeks|3 patients dropped out, 4 patients did not meet criteria, and 3 patients did not show up.||scores on a scale||Standard Deviation|Mean
91837|NCT00887679|Primary|Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory|"Scoring~The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:~(0) I do not feel sad.~I feel sad.~I am sad all the time and I can't snap out of it.~I am so sad or unhappy that I can't stand it.~A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[6] 0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|baseline and 7 weeks|||units on a scale||Standard Deviation|Mean
91838|NCT00887679|Primary|Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.|baseline and 7 weeks|3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.||scores on an anxiety scale||Standard Deviation|Mean
91840|NCT00887653|Secondary|Proportion of Patients With Plasma Viral Load Below the Limit of Detection|Assess proportion of patients with PVL below limit of detection at end of study.|6 months|One subject was prematurely discontinued from the study at week 12 due to detectable HIV-1 RNA of 57 copies/mL that was sustained at 61 copies on repeated measurement two weeks later.||proportion of participants|||Number
91841|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 3 months|3 months|||units on a scale||Full Range|Median
91842|NCT00887640|Secondary|Safety and Tolerability of Temsirolimus|Total number of grade 3, 4, and 5 adverse events at least possibly related to temsirolimus therapy. Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to 4.0 for the purposes of reporting to ClinicalTrials.gov.|2 years|||Adverse Events|||Number
91843|NCT00887640|Secondary|Change Over Time in CTC Gene Expression Profile|Percent change in CTC gene expression from baseline to 8 or 12 weeks of treatment.|12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.|||||
91844|NCT00887640|Secondary|Time to Second PSA Progression After Addition of Anti-androgen Therapy|Time in months from the time of anti-androgen therapy to the date of second PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to second PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. Patients progressed radiographically before 2nd PSA progression occurred.|||||
91845|NCT00887640|Secondary|Time to PSA Progression|Time in months from the start of study treatment to the date of first PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. PSA responses were not observed in this study and PSA progression dates would essentially be the same as the radiographic PFS dates.|||||
91846|NCT00887640|Secondary|Maximum Rate of Change of Prostate-Specific Antigen (PSA).|Percent change in PSA between baseline and the measurement time point where the largest change in PSA occurred. Note that a positive change (greater than 0) indicates an increase in PSA, and a negative change (less than 0) indicates a decrease.|Baseline to 7 months|||Percent change||Full Range|Median
91847|NCT00887640|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Clinical Trial Working Group 2 (PCWG2) criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Additionally, according to PCWG2 criteria, disease progression in bone is defined as 2 or more new lesions seen on bone scan compared with the baseline scan used for trial entry. Per PCWG2 guidelines, therapy was not discontinued solely due to a rise in PSA alone.|2 years|||Months||95% Confidence Interval|Median
91848|NCT00887640|Secondary|Percent Change in LDH|To evaluate and correlate changes in serum Lactate Dehydrogenase (LDH) with CTC count changes over time in men with Castrate Resistant Prostate Cancer (CRPC) treated with temsirolimus|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.|||||
91849|NCT00887640|Secondary|Mean Percent of N-cadherin Expression at Baseline and 8 Weeks of Treatment.|Measures of epithelial plasticity on CTCs in response to Mammalian Target of Rapamycin (mTOR) inhibition with temsirolimus, using genomic and protein immunohistochemical methodology. N-cadherin was measured in CTCs captured using the CellSearch profile kit. The proportion of CTCs expressing N-cadherin was calculated and divided by the total number of CD45-negative, pan cytokeratin (CK) – positive, and 4’,6-diamidino-2-phenylindole (DAPI+) intact cells to give a fractional expression of N-cadherin. Results are reported as a percentage.|Baseline and 8 weeks|N-cadherin expression at both baseline and 8 weeks was evaluable in 7 patients.||Percent expression||Full Range|Median
91850|NCT00887640|Secondary|Percent Change in CTC Count From Baseline to 12 Weeks of Treatment.|To evaluate the change in CTC counts upon the addition of an anti-androgen upon PSA progression while on temsirolimus therapy|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Outcome not available at 12 weeks. CTCs were not collected at week 12 and thus were not analyzed.|||||
91851|NCT00887640|Primary|Change in Circulating Tumor Cell (CTC) Counts in Men With Metastatic Treatment-refractory Castration-resistant Prostate Cancer.|Median percent change in CTC count from baseline to 8 weeks of treatment. Percent change was calculated by determining the percentage increase or decrease in CTC count from baseline.|Baseline to 8 weeks|CTC count at both baseline and week 8 were assessable in 8 of the 11 patients as CTCs were collected at both time points in these patients. Missing CTC data for 3 of the 11 patients due to laboratory error or no CTC available at various time points.||percent change||Inter-Quartile Range|Median
91852|NCT00887588|Secondary|Change From Baseline in Sitting SBP, Sitting DBP and Sitting Pulse Pressure (PP)|Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||mmHg||Standard Error|Least Squares Mean
91853|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||cm/s||Standard Error|Least Squares Mean
91906|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91854|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||bpm||Standard Error|Least Squares Mean
91855|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate Correct Cen Aug/Pulse Ht|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||Percent||Standard Error|Least Squares Mean
91856|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Brachial Systolic Blood Pressure (SBP), Brachial Diastolic Blood Pressure (DBP), Central Augmentation Pressure, Central Pressure at T1-DP, Central SBP, Central DBP, Central Mean Pressure|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.||mmHg||Standard Error|Least Squares Mean
91857|NCT00887588|Secondary|Change From Baseline in Albumin/Creatinine Ratio|Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio||95% Confidence Interval|Geometric Mean
91858|NCT00887588|Secondary|Change From Baseline in Serum Creatinine|Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||µmol/L||Standard Error|Least Squares Mean
91859|NCT00887588|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||mL/min/1.73m^2||Standard Error|Least Squares Mean
91860|NCT00887588|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class I, II, II or IV|The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||Percentage of participants|||Number
91861|NCT00887588|Secondary|Percentage of Participants With Clinical Composite Assessment of Improved, Unchanged or Worsened|The clinical composite assessment is defined as follows: Improved = a) participant improved (markedly or moderately) in the global assessment of disease activity with no worsening of NYHA functional class and no major adverse cardiovascular event or b) participant improved in NYHA functional class with no worsening (markedly or moderately) in the global assessment of disease activity and no major adverse cardiovascular event. Worsened = participant worsened (markedly or moderately) in the global assessment of disease activity or in NYHA functional class or experienced a major adverse cardiovascular event. Unchanged = participant does not meet the definition for improved or worsened.|36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||Percentage of participants|||Number
91862|NCT00887588|Secondary|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and Individual Domain Summary Scores|The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each domain, were included in the analysis for that domain. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||score on a scale||Standard Error|Least Squares Mean
91863|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||m/s||Standard Error|Least Squares Mean
91864|NCT00887588|Secondary|Change in Echocardiography Parameters: Isovolumic Relaxation Time|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ms||Standard Error|Least Squares Mean
91865|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio||Standard Error|Least Squares Mean
91866|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||cm/s||Standard Error|Least Squares Mean
91867|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ml/m^2||Standard Error|Least Squares Mean
91868|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||g/m^2||Standard Error|Least Squares Mean
91869|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||grams (g)||Standard Error|Least Squares Mean
91870|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||Percent ejection fraction||Standard Error|Least Squares Mean
91871|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ml||Standard Error|Least Squares Mean
91872|NCT00887588|Secondary|Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||cm||Standard Error|Least Squares Mean
91873|NCT00887588|Secondary|Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)|Evaluation of cGMP was performed by a central laboratory. Change from baseline in cGMP was presented as a ratio where the ratio was calculated as the cGMP value at 36 weeks over the cGMP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio: endpoint/baseline (nmol/L)||95% Confidence Interval|Geometric Mean
91874|NCT00887588|Secondary|Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP)|Evaluation of NT-proBNP and BNP was performed by a central laboratory. Change from baseline in NT-proBNP and in BNP was presented as a ratio where the ratio for NT-proBNP was calculated as the NT-proBNP value at 36 weeks over the NT-proBNP value at baseline, and the ratio for BNP was calculated as the BNP value at 36 weeks over the BNP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
91999|NCT00886899|Secondary|Total Procedure Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Procedure time data for two participants was not available.||minutes||Standard Deviation|Mean
91875|NCT00887588|Primary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|Evaluation of NT-proBNP was performed by a central laboratory. Change from baseline in NT-proBNP was presented as a ratio where the ratio was calculated as the NT-proBNP value at 12 weeks over the NT-proBNP value at baseline. A ratio < 1 indicates improvement.|Baseline, 12 weeks|Participants from the full analysis set (FAS), who had both baseline and 12 week values, were included in the analysis. The FAS consisted of all randomized participants who had baseline and at least one post-baseline efficacy measurement during the double blind period.||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
91876|NCT00887575|Secondary|Overall Survival (OS)|Defined as the time between Day 1 Cycle 1 to time of death from any cause.|24 months|||probability of overall survival at 24 m||95% Confidence Interval|Number
91877|NCT00887575|Secondary|Disease-free Survival|Defined as the time between day of surgery to first documented disease occurrence or death due to any cause.|every 4 weeks from date of surgery until treatment discontinuation or death, expected average 18 months|||months||90% Confidence Interval|Median
91878|NCT00887575|Secondary|Overall Response Rate (ORR)|Assessed by clinical, radiologic and surgical determinations before and after neoadjuvant therapy. Measurable lesions will be defined by RECIST criteria v1.1.|Days 1, 8 and 15 of each cycle, minimum of 12 weeks|Patients who were enrolled, treated at the MTD and completed at least 3 cycles of neoadjuvant therapy||participants|||Number
91879|NCT00887575|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of reported incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) at the phase II dose|Days 1, 8, and 15 of each 4-week cycle up to 24 weeks during neoadjuvant treatment, and every 4 weeks during maintenance treatment|The safety analysis includes all eligible patients enrolled at the MTD, whether or not treatment was recieved (6 patients in Phase I were treated at the MTD, 39 patients were enrolled in Phase II, 3 were deemed ineligible after enrollment-thus 42 patients are included in the safety analysis, including 1 eligible patient who was not treated)||participants|||Number
91880|NCT00887575|Primary|Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin|Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.|at weeks 26-30|Patients treated at Dose Level I (Phase I and Phase II) who underwent surgery||participants|||Number
91881|NCT00887562|Secondary|Mean Change in Score on the Fatigue Severity Scale (FSS)|"To assess changes following 1 month treatment with 2 different doses of idebenone with that of placebo in fatigue as assessed by the Fatigue Severity Scale (FSS).~Scale score minimum is 9 (least fatigue) and maximum is 63 (maximum fatigue). Scores of 36 or less indicate possibility that patient may not be suffering from fatigue, while scores 36 and over suggest suffering from fatigue"|Baseline and Week 4|||units on a scale||Standard Deviation|Mean
91882|NCT00887562|Secondary|Mean Change in Venous Lactate Concentration|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on venous lactate concentration|Up to 4 weeks from baseline|||mM/L||Standard Deviation|Mean
91883|NCT00887562|Primary|Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on cerebral lactate concentration as measured by magnetic resonance spectroscopy (MRS)|Up to 4 weeks from baseline|||IU||Standard Deviation|Mean
91884|NCT00887549|Secondary|Percentage of Participants Surviving at 18 Months (Overall Survival Rate)|The percentage of participants surviving at 18 months was defined as the number of treated participants who had not died prior to 18 months from the date of their first dose divided by the total number of treated participants multiplied by 100. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death (up to 24.5 months)|All enrolled participants. Nineteen participants were censored for overall survival.||percentage of participants||95% Confidence Interval|Number
91885|NCT00887549|Secondary|Percentage of Participants With Concordance Between Local and Central Histological Diagnosis|A centralized pathology review on all enrolled participants was performed to confirm the histological diagnosis performed at the site. Upon review of the local diagnosis obtained at the respective site, the central reviewer established whether or not there was an agreement between the local and central diagnosis. The percentage of participants with concordance was defined as the number of participants for which there was an agreement divided by the number of treated participants (concordance rate) multiplied by 100.|Baseline|All enrolled participants.||percentage of participants||95% Confidence Interval|Number
91886|NCT00887549|Secondary|Percentage of Participants With Tumor Response (Tumor Response Rate)|Tumor response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Percentage of participants with tumor response was determined by the number of participants with PR or CR (confirmed or not) divided by the total number of treated participants multiplied by 100.|Baseline to disease progression (up to 20 months)|All enrolled participants.||percentage of participants||95% Confidence Interval|Number
91887|NCT00887549|Primary|Progression Free Survival (PFS)|PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.|Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)|Population for the efficacy assessment includes all treated participants with a valid TS expression assessment. Six participants were censored for PFS.||months||95% Confidence Interval|Median
91888|NCT00887510|Secondary|Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril|"Comparing the change in adiponectin: rand 1 visit4-visit 3 with rand 2 visit 3-2.~This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril."|Over the course of 18 weeks|||mcg/ml||Standard Deviation|Mean
91889|NCT00887510|Primary|Change in Oral Glucose Tolerance Test (OGTT) Area Under Curve (AUC) After Addition of Trandolapril to Hydrochlorothiazide (HCTZ) Compared With Change in OGTT AUC After Addition of HCTZ to Trandolapril|Comparing the change in OGTT AUC rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril. This is the primary outcome of the study.|OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.|||minutes*mg/dl||Standard Deviation|Mean
91890|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91891|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91892|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91893|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91894|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Week 8|ITT||Participants|||Number
91895|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Weeks 1 and 2|ITT||Participants|||Number
91896|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Week 8|ITT||Participants|||Number
91897|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Weeks 1 and 2|ITT||Participants|||Number
91898|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.|Week 8|ITT||Participants|||Number
91899|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91900|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91901|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91902|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91903|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.|Weeks 1 and 2|ITT. Data are presented for only those participants completing the questionnaire.||Participants|||Number
91904|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91905|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
92915|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
91907|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91908|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91909|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91910|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91911|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91912|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91913|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91914|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91915|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91916|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT||Units on a scale||Standard Deviation|Mean
91917|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT||Units on a scale||Standard Deviation|Mean
91918|NCT00887484|Secondary|Quality of Life Questionnaire - Global Score|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
91919|NCT00887484|Secondary|Quality of Life Questionnaire - Functional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
91920|NCT00887484|Secondary|Quality of Life Questionnaire - Emotional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
91921|NCT00887484|Secondary|Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28.|Baseline, Weeks 2 and 8|ITT||Units on a scale||Standard Deviation|Mean
91922|NCT00887484|Secondary|Non-inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Baseline, Weeks 5 and 8|ITT||Acne Lesions||Standard Deviation|Mean
91923|NCT00887484|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Baseline, Weeks 5 and 8|ITT||Acne Lesions||Standard Deviation|Mean
91924|NCT00887484|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Baseline, Weeks 5 and 8|ITT||Acne Lesions||Standard Deviation|Mean
92000|NCT00886899|Primary|30-day Major Adverse Cardiac Event (MACE) Rate|Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.|30 Days|"Includes 21 patients with early (<30 day) follow-up"||percentage of participants||90% Confidence Interval|Number
91925|NCT00887484|Secondary|Investigators Static Global Assessment|ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Baseline, Weeks 5, 8|For the first 2 weeks, participants apply one of the drugs (Clindoxyl or Epiduo) to one side of the face and the other drug to the other side of their face. After week 2, participants apply Clindoxyl to their entire face and do not use Epiduo.||units on a scale||Standard Deviation|Mean
91926|NCT00887484|Secondary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
91927|NCT00887484|Secondary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
91928|NCT00887484|Primary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT||units on a scale||Standard Deviation|Mean
91929|NCT00887484|Primary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense."|Weeks 1 and 2|ITT||units on a scale||Standard Deviation|Mean
91930|NCT00887484|Primary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT||units on a scale||Standard Deviation|Mean
91931|NCT00887484|Secondary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
91932|NCT00887484|Secondary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT||units on a scale||Standard Deviation|Mean
91933|NCT00887484|Primary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
91934|NCT00887471|Secondary|Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5|Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study|Baseline and 4 years|||participants|||Number
91935|NCT00887471|Primary|Median Change in Apnea-hypopnea Index (AHI)|Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point|Baseline and 4 years|||events per hour of sleep||Standard Deviation|Median
91936|NCT00887458|Secondary|To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.||approximately 2 years from open enrollment||||||
91937|NCT00887458|Primary|To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.|"To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. PSA progression is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later."|Up to 24 weeks|Based on how many participants were evaluable for the study primary endpoint||percent of patients||95% Confidence Interval|Number
91938|NCT00887354|Secondary|"Timed Up and Go Test"|"Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley’s pain score."|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||seconds (sec)||Standard Error|Least Squares Mean
91939|NCT00887354|Secondary|Visual Analog Scale (VAS)|Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||millimeter (mm)||Standard Error|Least Squares Mean
92001|NCT00886899|Primary|Technical Success|Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire|Intraprocedural|Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants.||percentage of CTOs|Participants|90% Confidence Interval|Number
91940|NCT00887354|Secondary|Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale|Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.|Baseline|All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.||percentage of participants|||Number
91941|NCT00887354|Secondary|Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire|SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).|Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||units on a scale||Standard Error|Least Squares Mean
91942|NCT00887354|Secondary|Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb|"Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .~Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use."|Baseline, Week 26; Baseline, Week 52; Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||g/cm^2||Standard Error|Least Squares Mean
91943|NCT00887354|Secondary|Change in Lumbar Spine Areal Bone Mineral Density|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 26; Baseline, Week 52|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||g/cm^2||Standard Error|Least Squares Mean
91944|NCT00887354|Primary|Change in Lumbar Spine Areal Bone Mineral Density (BMD)|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.||gram per square centimeter (g/cm^2)||Standard Error|Least Squares Mean
91945|NCT00887341|Secondary|Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91946|NCT00887341|Secondary|HAQ-DI Score by Visit|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
91947|NCT00887341|Secondary|Erythrocyte Sedimentation Rate|ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement.|Baseline, Weeks 2, 4, 8, 12,16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
91948|NCT00887341|Secondary|C-Reactive Protein (CRP) Levels|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L).|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/L||Standard Deviation|Mean
91949|NCT00887341|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)|ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91950|NCT00887341|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)|ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
92458|NCT00883090|Primary|Mean Residence Time||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||days||Standard Deviation|Mean
91951|NCT00887341|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)|ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91952|NCT00887341|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)|ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein [CRP])|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91953|NCT00887341|Secondary|DAS28 Score by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value.|Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n (number)=number of participants analyzed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
91954|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT population||percentage of participants|||Number
91955|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <3.2 by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91956|NCT00887341|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91957|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab for Any Reason||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91958|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population||percentage of participants|||Number
91959|NCT00887341|Primary|Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||percentage of participants|||Number
91960|NCT00887315|Secondary|Overall PFS and CT Rate|Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines|>90 days|The study was terminated before conclusions were reached so no data was analyzed.|||||
91961|NCT00887315|Primary|1-Year Overall Survival|Overall survival is assessed at 1 year from the date of study enrollment to date of death.|Baseline to death from any cause, 1 year|The study was terminated before conclusions were reached so no data was analyzed.|||||
91962|NCT00887289|Secondary|Behavioural Changes During Treatment|Number of patients with occurence of behavioural changes in terms of impulse control disorders|Baseline to Visit 3|Full analysis set, no imputation technique was applied||participants|||Number
91963|NCT00887289|Secondary|Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3|Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.|Baseline to Visit 3|Full analysis set, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
91964|NCT00887289|Secondary|Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3|Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.|Baseline to Visit 3|Full analysis set (FAS)||Scores on scale||Standard Deviation|Mean
91965|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a neurologist, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
92002|NCT00886834|Secondary|Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)|VAS; anchors: 0 =none, 100 mm= worst imaginable|prior to insertion, immediately after insertion, and prior to clinic discharge|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.||units on a scale||Standard Deviation|Mean
91966|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a general practitioner, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
91967|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|Full analysis set, no imputation technique was applied||Scores on scale||Standard Deviation|Mean
91968|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
91969|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
91970|NCT00887250|Secondary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
91971|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 12|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
91972|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 6|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
91973|NCT00887250|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
91974|NCT00887224|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase|WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.||scores on a scale||Standard Error|Mean
91975|NCT00887224|Secondary|Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index|WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
91976|NCT00887224|Secondary|Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.|Double-blind phase Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).||participants|||Number
91977|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase|HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
91978|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
91979|NCT00887224|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.||scores on a scale||Standard Error|Mean
91980|NCT00887224|Secondary|Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).||participants|||Number
91981|NCT00887224|Primary|Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185|Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).|Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)|All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.||percent estimated probability|||Number
91982|NCT00887198|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
91983|NCT00887198|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
91984|NCT00887198|Secondary|Maximum Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
91985|NCT00887198|Secondary|Mean Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.|||||
91986|NCT00887198|Secondary|Number of Participants With Treatment Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From first dose of study drug up to 30 days after the last dose of study drug|Safety analysis set included all participants in the randomized population who received any study drug.||Participants|||Number
91987|NCT00887198|Secondary|Time to Prostate-specific Antigen (PSA) Progression|The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.|From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
92764|NCT00879775|Secondary|Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of impact of symptom burden to daily life.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
91988|NCT00887198|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point|The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
91989|NCT00887198|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
91990|NCT00887198|Secondary|Time to Opiate Use for Prostate Cancer Pain|The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first opiate use or end of study (Month 60)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
91991|NCT00887198|Primary|Radiographic Progression-free Survival (rPFS)|The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
91992|NCT00887198|Primary|Overall Survival|Overall survival is defined as the time from randomization to date of death from any cause.|From randomization (Day 1) up to end of study (Month 60)|Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.||Months||95% Confidence Interval|Median
91993|NCT00887159|Secondary|PFS|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients who had baseline CTC results available for analysis.||months||95% Confidence Interval|Median
91994|NCT00887159|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.||months||95% Confidence Interval|Median
91995|NCT00887159|Secondary|Response Rate|Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.||Proportion of patients||95% Confidence Interval|Number
91996|NCT00887159|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.||months||95% Confidence Interval|Median
91997|NCT00886938|Primary|Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)|Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.|0,4 weeks|Total number of participants completing the full four weeks of treatment, according to protocol.||units on a scale||95% Confidence Interval|Mean
91998|NCT00886899|Secondary|Total Procedural Fluoroscopy Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Fluoroscopy time was not available for two participants||minutes||Standard Deviation|Mean
94470|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 1|Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg|week 1|FAS (LOCF)||participants|||Number
92003|NCT00886834|Primary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)|VAS (anchors: 0 = extremely easy, 100 mm= impossible)|Immediately post IUD insertion|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.||units on a scale||Standard Deviation|Mean
92004|NCT00886795|Secondary|Number of Participants With Clinically Detectable Improvement|Evaluations will occur at each visit after the first infusion. At 3 months, response will be recorded and patients with improvement will be eligible to move into the steroid and/or antihistamine tapering portion of the study. Improvement was determined by a reduction in the number of hives.|at each visit and at 3 months|||participants|||Number
92005|NCT00886795|Primary|Number of Participants With Adverse Events|Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.|baseline, 3 month and 6 months|Participants who received all four doses.||participants|||Number
92006|NCT00886769|Secondary|Change in Disability Score Over Time by Use of the CHAQ|The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’(0) to ‘unable to do’ (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.|At 4 week study period|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Units on a Scale||Standard Error|Least Squares Mean
92007|NCT00886769|Secondary|Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire – Parent Form (CHQ-PF50)|CHQ-PF50 measures HRQoL in children 5-18 years old from parent’s perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.|Over 4 week study period (Baseline, Day 15, Day 29)|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed.||units on a scale||Standard Error|Least Squares Mean
92008|NCT00886769|Secondary|Percentage of Patients Who Had Body Temperature ≤ 38°C|Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.|Day 3|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Percent of participants|||Number
92009|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ|CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’(0) to ‘unable to do’ (3). The parent’s or patient’s pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Units on a scale||Standard Error|Least Squares Mean
92010|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)|CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’ (0) to ‘unable to do’ (3). The parent’s or patient’s pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 15|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.||Units on a scale||Standard Error|Least Squares Mean
92011|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 100|Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation|baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percent of participants|||Number
92012|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 90|Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percent of participants|||Number
92048|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.|Post-treatment at session 40|Participants in both Active and Sham Neurofeedback completing 40 treatment sessions.||percentage of participants|||Number
92013|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 70|Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percent of participants|||Number
92014|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria|Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percentage of participants|||Number
92015|NCT00886769|Primary|Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria|Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.||percentage of participants|||Number
92016|NCT00886704|Primary|Omega-3 Index|Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index. Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%. Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit. Values of the HS-Omega-3 Index have been found between 1.5% and 20%.|after eight weeks of intervention|||% EPA+DHA in total red cell fatty acids||Standard Deviation|Median
92017|NCT00886704|Secondary|Palatability|Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome|at 8 weeks|Per protocol analysis||Number on a scale from 0 - 10||Standard Deviation|Mean
92018|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 22: minute 0 and 6||||||
92019|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 21: minute 0 and 6||||||
92020|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 2: minute 0 and 6||||||
92021|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 2: minute 0 and 6"||||||
92022|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 20: minute 0 and minute 6||||||
92023|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 21: minute 0 and minute 6||||||
92024|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 22: minute 0 and minute 6||||||
92025|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 2: minute 0 and minute 6||||||
92026|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 21: minute 0 and minute 6||||||
92027|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 1: minute 0 and 6||||||
92028|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 1: minute 0 and minute 6||||||
92029|NCT00886639|Secondary|Lung Function|change in lung function from baseline to 3 weeks|day 1 and 21||||||
92030|NCT00886639|Secondary|Diffusion Capacity|change in diffusion capacity from baseline to 3 weeks|day 1 and 21||||||
92031|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 1: minute 0 and 6"||||||
92032|NCT00886639|Primary|Oxygen Response|Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks|day 1 and day 2; day 21 and day 22|per protocol||Meter||Standard Deviation|Mean
92033|NCT00886626|Primary|Change in Body Mass Index (BMI)|Change in body mass index (BMI) over three months|3-month|Data from all participants who completed the trial were analyzed.||change in kg/m^2||Standard Deviation|Mean
92034|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B)|The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen.|1-5 days post administration of each VZV skin test|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.||Participants|||Number
92049|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #2. Retention|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).|40th treatment sessions ~ 13-20 weeks|Number randomized was denominator for percentage of participants completing 40 treatment sessions.||percentage of participants|||Number
94471|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 2|DBP < 90 mmHg|week 2|FAS (LOCF)||participants|||Number
92035|NCT00886613|Primary|Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)|"Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination.~For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test."|48-72 hours after administration of skin test at 14-17 days postdose 2|Per protocol population - participants with a negative baseline VZV Skin Test (<5 mm skin reaction to both, saline and the VZV skin test reagent), and who did not have a protocol deviation that could interfere with the immune response to vaccine following two administrations of either ZOSTAVAX™, placebo, or V212||Participants|||Number
92036|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B)|The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included.|1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.||Participants|||Number
92037|NCT00886613|Secondary|VZV Skin Test Reactions at 48 and 72 Hours (Part A)|Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test.|48 hours and 72 hours post administration of baseline skin test|42 participants enrolled in Part A||Participants|||Number
92038|NCT00886613|Primary|Number of Participants With a Negative VZV Skin Test at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test.|48 hours following administration of the baseline skin test|Participants enrolled in Part A with a negative reaction for saline.||Participants|||Number
92039|NCT00886613|Other Pre-specified|Number of Participants With a Negative Reaction for Saline at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms. The skin reaction (erythema and induration) to saline was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline had a negative reaction for saline, and measure >= 5mm for saline had a positive reaction for saline at baseline.|48 hours following administration of the baseline skin test|42 participants enrolled in Part A||Participants|||Number
92040|NCT00886600|Secondary|Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
92041|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
92042|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4||Baseline and 24-hours after morning dose at Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
92043|NCT00886600|Primary|Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24-hour period at baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
92044|NCT00886600|Primary|Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24 hour period at Baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."||mm Hg||Standard Deviation|Mean
92045|NCT00886483|Primary|Necessary Duration of Treatment|The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.|40 treatment sessions ~ 13-20 weeks|Number of participants in active (n=24) and sham (n=10) neurofeedback completing 40 treatments.||units on a scale||Standard Deviation|Mean
92046|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice|Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.|24 treatments ~ 8-12 weeks|participants completing treatment 24||percentage of participants|||Number
92047|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction|Parent & child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).|24 treatments ~ 8-12 weeks|Those completing 24 treatments||units on a scale||Standard Deviation|Mean
92050|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number|The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.|2 years|Based on inclusion & exclusion criteria and randomization in a 2:1 ratio to active NF vs. sham NF.||participants|||Number
92051|NCT00886340|Secondary|Quality of Life||6 months||||||
92052|NCT00886340|Secondary|Lipids||6 months||||||
92053|NCT00886340|Secondary|Diet and Exercise Behavior||6 months||||||
92054|NCT00886340|Primary|Number of Participants Who Met Weight Loss Goal of 5% Weight Loss||6 months|||participants|||Number
92055|NCT00886288|Secondary|Percentage of Patients With Positive to Negative Shift in Albuminuria|Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks|Approximately 12 weeks (10 to 14 weeks) after baseline|All patients with albuminuria at initial visit and for which information on albuminuria was known at visit 2, 12 weeks after the initial visit.||Percentage of patients||95% Confidence Interval|Number
92056|NCT00886288|Secondary|Percentage of Patients Presenting an Adverse Event (AE)|Percentage of patients with any adverse events during the study period, related or not to investigational drug|baseline to the end of study period|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||percentage of patients|||Number
92057|NCT00886288|Secondary|Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)|The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) – SBP (12 weeks) ≥ 10 mmHg|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||Percentage of patients|||Number
92058|NCT00886288|Secondary|Mean Difference in Diastolic Blood Pressure|The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) – DBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||mmHg||Standard Deviation|Mean
92059|NCT00886288|Secondary|Mean Difference in Systolic Blood Pressure|The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) – SBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||mmHg||Standard Deviation|Mean
92060|NCT00886288|Primary|Percentage of Patients With Controlled Blood Pressure|"Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg if the patient has:~no chronic renal insufficiency or macroalbuminuria-dipsticks negative,~albuminuria is < 300 mg/24h or < 200 mg albumin per gram of creatinine~no diabetes~or SBP < 130 mmHg and DBP < 80 mmHg if the patient has:~chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine~diabetes (type 1 or 2)"|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)||Percentage of patients|||Number
92061|NCT00886145|Primary|Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months|Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography|The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy|||Percent Change|||Number
92062|NCT00886119|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.||logMAR||Standard Deviation|Mean
92063|NCT00885846|Primary|Fasting Blood Glucose||Week 0 (baseline) and week 12 (final)|Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.||mg/dL||Standard Deviation|Mean
92064|NCT00885846|Secondary|Fasting Cortisol||Weeks 0 and 12||||||
92065|NCT00885846|Secondary|HOMA-IR Index||weeks 0 and 12||||||
92066|NCT00885846|Secondary|Beck's Depression Inventory (BDI)||weeks 0 and 12||||||
92067|NCT00885846|Secondary|Perceived Stress Scale (PSS)||weeks 0 and 12||||||
92068|NCT00885846|Secondary|Fasting Insulin||weeks 0 and 12||||||
92069|NCT00885846|Secondary|Fasting C-peptide||weeks 0 and 12||||||
92070|NCT00885768|Primary|The Number of Patients With Renal Artery Stenosis|the prevalence of renal artery stenosis in patients with coronary artery disease|3months|||participants|||Number
92071|NCT00885768|Primary|Prevalence of Renal Artery Stenosis (RAS)||2 months||||||
92072|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.||percentage of participants|||Number
92081|NCT00885755|Secondary|Part I: PFS in ITT Population|PFS was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]).. In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
92073|NCT00885755|Primary|Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm.PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (<median/≥median) , PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.||percentage of participants|||Number
92074|NCT00885755|Primary|Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker|BOR was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST). CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (median/≥median), PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.||percentage of participants|||Number
92075|NCT00885755|Primary|Part II: TTP by Biomarker|TTP was calculated from first study medication in Part II to date of progression. The relationship between TTP and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT .|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
92076|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.||percentage of participants|||Number
92077|NCT00885755|Secondary|Overall Survival in ITT Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|ITT population||months||Full Range|Median
92078|NCT00885755|Secondary|Overall Survival in Per Protocol Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|PP population||months||Full Range|Median
92079|NCT00885755|Secondary|Part II: PFS in ITT Population|PFS was calculated from first study medication in Part II to date of progression or death. In participants with measurable disease progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
92080|NCT00885755|Secondary|Part II: TTP in Intent to Treat (ITT) Population|TTP was calculated from first study medication in Part II to date of progression. In participants with measurable disease progression was defined according to RECIST(SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
92092|NCT00885742|Secondary|Association of the Incidence of Spontaneous Bleeding Events Requiring Treatment and FXIII Activity Trough Levels|P-value determined from Generalized Estimating Equation (GEE) model parameter estimates with bleeding as the response variable and FXIII activity trough level as the explanatory variable.|12 months|The analysis population comprised those subjects with spontaneous bleeding events requiring treatment with a FXIII-containing product. Note: no subjects had spontaneous bleeding events requiring treatment with a FXIII-containing product, so no subjects were analyzed.||participants|||Number
92082|NCT00885755|Primary|Part I: Time to Progression (TTP) by Biomarker|Progression was defined as an increase by at least 20% from the smallest value in the SLD of lesions.TTP was determined as the time in months from the date of screening until first progression.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT . The correlation between the biomarker variables and TTP were investigated using a univariate Cox regression model and time-to-event methods (Kaplan-Meier).|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
92083|NCT00885755|Primary|Part II: Progression Free Survival (PFS) by Biomarker|PFS was calculated from first study medication in Part II to date of progression or death.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95HER2 +ve and -ve population, IGF1R <median and ≥ median membrane H score, c-MET <median and ≥median membrane H score, PTEN <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
92084|NCT00885755|Secondary|Part I: TTP in Intent to Treat (ITT) Population|TTP was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.||months||95% Confidence Interval|Median
92085|NCT00885755|Primary|Part I: Progression Free Survival (PFS) by Biomarker|Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (<) median and greater than or equal to (≥) median membrane H score, c-MET <median and ≥median membrane H score, phosphatase and tensin homolog gene (PTEN) <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, phosphatidylinositol-3-kinase (PI3K) catalytic subunit wild type (WT) and mutation (M), and FC gamma receptors IIIa homozygous Phenyl alanine (FF), heterozygous Phenyl alanine/Valine (VF) and homozygous Valine (VV), receptor IIa Phenotypes homozygous Histidine (HH), heterozygous Histidine/Arginine (HR) and homozygous Arginine (RR) IIb phenotypes homozygous Isoleucien (II),heterozygous Isoleucine/Threonine (IT) and homozygous Threonine (TT) .|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|Per Protocol (PP) population included all participants who had received a complete first dose of study medication and had baseline and at least one on-treatment biomarker assessment. Number (n) equals (=) number of participants with biomarker data available for the specified biomarker.||months||95% Confidence Interval|Median
92086|NCT00885742|Secondary|Achievement of Trough Factor XIII Levels of 5% or Higher.|Number of subjects with Factor XIII level ≥ 5% before infusion at Week 12, Week 24, Week 36 and Week 48.|At 12, 24, 36 and 48 weeks: immediately before infusion.|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.||participants|||Number
92087|NCT00885742|Secondary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of (U/kg) infusion.|At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Units/mL/Units/kg||Standard Deviation|Mean
92088|NCT00885742|Secondary|Time to Peak Concentration||At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Hour||Standard Deviation|Mean
92089|NCT00885742|Secondary|Trough FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: immediately before infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Units/mL||Standard Deviation|Mean
92090|NCT00885742|Secondary|Peak FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).||Units/mL||Standard Deviation|Mean
92091|NCT00885742|Secondary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment related AEs are defined as AEs whose relationship to study treatment is related, or possibly related, and AEs with missing relationship.|12 months|The Safety Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study.||participants|||Number
92916|NCT00877929|Secondary|Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 8|Treated set using last observation carried forward (LOCF)||participants|||Number
92093|NCT00885742|Primary|The Incidence of Spontaneous Bleeding Events Requiring Treatment (Treatment is Defined as Administration of a FXIII‑Containing Product to Treat the Bleeding Event)|The number of subjects requiring treatment with a Factor XIII-containing product to treat a spontaneous bleeding event.|Up to week 52|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.||participants|||Number
92094|NCT00885638|Secondary|Insulin Secretion After Ingestion of Meal|Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion|300 min|Completer population||mol/l/min||Standard Error|Mean
92095|NCT00885638|Primary|Glucagon-like Peptide-1 Secretion After Meal Ingestion|Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion|300 min|Completer population||nmol/l/min||Standard Error|Mean
92096|NCT00885534|Primary|Overall Response to CVT Chemotherapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years|||participants|||Number
92097|NCT00885482|Secondary|Change of Bone Density and of Subcutaneous Fat at 48 Weeks||48 weeks||||||
92098|NCT00885482|Secondary|Change of the Results of Neurocognitive Tests at 48 Weeks||48 weeks||||||
92099|NCT00885482|Secondary|Change of Metabolic Parameters at 48 Weeks||48 weeks||||||
92100|NCT00885482|Secondary|Evolution of Atazanavir Plasma Concentrations During the 48 Weeks||48 weeks||||||
92101|NCT00885482|Secondary|Evolution of Adherence and Quality of Life During the 48 Weeks||48 weeks||||||
92102|NCT00885482|Secondary|Evolution of CD4 Cell Count During the 48 Weeks||48 weeks||||||
92103|NCT00885482|Secondary|Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis||48 weeks||||||
92104|NCT00885482|Secondary|Time to Virological Failure at Survival Analysis||48 weeks||||||
92105|NCT00885482|Primary|Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis||48 weeks|||patients|||Number
92106|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria|Marked abnormality criteria were urine protein: if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine blood: if pre-Rx=0, use >=2, if pre-Rx=0.5 or 1, use >=3, if pre-Rx=2, use >=4; Urine red blood cell count (RBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine white blood cell count (WBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4.|Baseline, Week 12|All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.||Participants|||Number
92107|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. ULN=upper limit of normal; LLN=lower limit of normal.|Baseline, Week 12|All treated participants.||Participants|||Number
92108|NCT00885378|Primary|Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with both a baseline value and post-baseline value (up to Week 12).||Percentage of glycosylated hemoglobins||Standard Error|Mean
92109|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Heart Rate (HR)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.||mm Hg||Standard Error|Mean
92110|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.||mm Hg||Standard Error|Mean
92111|NCT00885378|Other Pre-specified|Participant Electrocardiogram (ECG) Status at Baseline and Week 12|Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.|Baseline, Week 12|All treated participants, excluding those with missing values.||Participants|||Number
92112|NCT00885378|Other Pre-specified|Participants With Confirmed Hypoglycemia|Confirmed hypoglycemia was defined by a fingerstick glucose value <= 50 mg/dL with associated hypoglycemia symptoms.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.||Participants|||Number
92113|NCT00885378|Other Pre-specified|Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.||Participants|||Number
92125|NCT00885365|Secondary|Change From Baseline to End of Weeks 4 and 8 in Pseudomonas Aeruginosa Log10 Bacterial Load in Sputum|If a participant had more than one Pseudomonas aeruginosa (PA) morphotype at a given visit, and therefore more than one bacterial load value, then the bacterial load value corresponding to the highest tobramycin minimal inhibitory concentration (MIC) value regardless of the PA morphotype was used. If the tobramycin MIC value was the same for different PA morphotypes, then the bacterial load value corresponding to morphotype 1 (mucoid colony) was used. If morphotype 1 was not available, bacterial load value corresponding to morphotype 2 (dry colony) was used.|Day -10 to -1 (baseline), Week 4, Week 8|Intent-to-Treat (ITT) Population; At Week 4, six Bramitob patients and seven TOBI patients were missing sputum samples. At Week 8, 11 Bramitob patients and 16 TOBI patients were missing sputum samples.||colony forming units/gram||Standard Deviation|Mean
92114|NCT00885378|Other Pre-specified|Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment.SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.||Participants|||Number
92115|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.||Percentage of Participants||95% Confidence Interval|Number
92116|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.||Percentage of Participants||95% Confidence Interval|Number
92117|NCT00885378|Secondary|Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).||mg / dL||Standard Error|Mean
92118|NCT00885365|Secondary|Participants With a Hearing Threshold >20 Decibel in at Least One Ear|The potential ototoxic effects (hearing loss) of tobramycin were investigated by performing audiometric tests. Participants with a loss of auditory acuity greater than the 20 decibels auditory threshold are reported.|Day -10 to -1 (screening), Weeks 4 and 8|Safety population||percentage of participants|||Number
92119|NCT00885365|Secondary|Count of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-Emergent Adverse Events defined as adverse events occurring after the first intake of study treatment (or the same day).~The investigator assessed relation to study treatment as a binary question: Reasonable possibility of relatedness or no reasonable possibility of relatedness. The expression “reasonable possibility of relatedness” is meant to convey in general that there are facts (evidence) or arguments meant to suggest a causal relationship.~A serious AE results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or an important medical event.~The investigator rates the severity of the AE based on a three point scale: mild, moderate or severe. A severe event prevents any usual routine activity of the participant and causes severe discomfort."|Day 0 to Week 8|Safety population: all randomised patients who took at least one dose of study medication||percentage of participants|||Number
92120|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Mass Index (BMI)||Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.||kilograms/meters^2||Standard Deviation|Mean
92121|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Weight|Body weight was measured at all study visits as part of the physical examination.|Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.||kilograms||Standard Deviation|Mean
92122|NCT00885365|Secondary|Microbiological Outcome Summary by Visit|"Microbiological outcomes are derived considering all P. aeruginosa (PA) morphotypes together.~Week 4 and Week 8 microbiological outcomes:~Eradication = elimination of PA~Persistence = persistence of PA detected at previous visit~Superinfection = appearance of a pathogen (other than PA) not detected at previous visit~Re-infection (week 8 only) = re-appearance of PA detected at Screening and eradicated at Week 4~Superinfection supersedes eradication. Persistence for P. aeruginosa supersedes superinfection.~Re-infection for P. aeruginosa supersedes superinfection."|Day -10 to -1 (screening), Weeks 4 and 8|Intent-to-Treat Population.||percentage of participants|||Number
92123|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 90% (MIC90) of Pseudomonas Aeruginosa|"MIC90 is the concentration of tobramycin required to inhibit 90% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:~Morphotype 1: mucoid~Morphotype 2: dry~Morphotype 3: variant~Overall MIC90 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population||micrograms/milliliters|||Number
92124|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 50% (MIC50) of Pseudomonas Aeruginosa|"MIC50 is the concentration of tobramycin required to inhibit 50% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:~Morphotype 1: mucoid~Morphotype 2: dry~Morphotype 3: variant~Overall MIC50 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population||micrograms/milliliters|||Number
92189|NCT00884832|Secondary|Percentage of Bowel Movements Preceded by Rectal Urgency|Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
92126|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%)|Difference in the forced expiratory flow rate in mid-exhalation measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.||liters/second||Standard Deviation|Mean
92127|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%), Expressed as Percentage of Predicted Normal|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated). Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEF 25-75% values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.||percentage predicted FEF 25-75%||Standard Deviation|Mean
92128|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.||liters||Standard Deviation|Mean
92129|NCT00885365|Secondary|Change From Baseline at End of Weeks 2, 4, and 8 of Forced Vital Capacity (FVC) Expressed as Percentage of Predicted Normal|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FVC values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.||percentage predicted FVC||Standard Deviation|Mean
92130|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.||liters||Standard Deviation|Mean
92131|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.||percentage predicted FEV1||Standard Deviation|Mean
92132|NCT00885365|Primary|Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded.|Day 0 (baseline), Week 4|Intent-to-Treat (ITT) Population, Last Observation Carried Forward (LOCF)||percentage predicted FEV1||Standard Deviation|Mean
92133|NCT00885352|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
92134|NCT00885352|Secondary|Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
92135|NCT00885352|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
92136|NCT00885118|Secondary|CLR,ss|renal clearance of the analyte at steady state determined over the dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
92137|NCT00885118|Secondary|fe0-24,ss|fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
92138|NCT00885118|Secondary|Ae0-24,ss|amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol||Geometric Coefficient of Variation|Geometric Mean
92139|NCT00885118|Secondary|RA,AUC|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||ratio||Geometric Coefficient of Variation|Geometric Mean
92140|NCT00885118|Secondary|RA,Cmax|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||ratio||Geometric Coefficient of Variation|Geometric Mean
92141|NCT00885118|Secondary|Vz/F,ss|apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||Liter||Geometric Coefficient of Variation|Geometric Mean
92142|NCT00885118|Secondary|CL/F,ss|apparent clearance of the analyte in plasma after extravascular administration at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
92143|NCT00885118|Secondary|t1/2,ss|terminal half-life of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||hour||Geometric Coefficient of Variation|Geometric Mean
92144|NCT00885118|Secondary|Cmax,ss|maximum measured concentration of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol/L||Geometric Coefficient of Variation|Geometric Mean
92145|NCT00885118|Secondary|AUCτ,ss|area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
92146|NCT00885118|Secondary|CLR,0-24|renal clearance of the analyte in plasma after extravascular administration – based on 0-24 hours data|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
92147|NCT00885118|Secondary|fe0-24|fraction of the analyte excreted unchanged in urine from time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
92148|NCT00885118|Secondary|Ae0-24|amount of the analyte that is eliminated in urine over the time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol||Geometric Coefficient of Variation|Geometric Mean
92149|NCT00885118|Secondary|Vz/F|apparent volume of distribution during the terminal phase λz following an extravascular dose|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||Liter||Geometric Coefficient of Variation|Geometric Mean
92150|NCT00885118|Secondary|CL/F|apparent clearance of the analyte in plasma after extravascular administration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||mL/min||Geometric Coefficient of Variation|Geometric Mean
92151|NCT00885118|Secondary|t1/2|terminal half-life of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||hour||Geometric Coefficient of Variation|Geometric Mean
92152|NCT00885118|Secondary|Cmax|maximum measured concentration of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol/L||Geometric Coefficient of Variation|Geometric Mean
92153|NCT00885118|Secondary|AUC0-∞|area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
92154|NCT00885118|Secondary|AUC0-tz|area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
94575|NCT00859430|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
92155|NCT00885118|Secondary|AUCτ,1|Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
92156|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)||hr*uU/mL||Standard Error|Least Squares Mean
92157|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)||hr*pg/mL||Standard Error|Least Squares Mean
92158|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)||hr*mg/dL||Standard Error|Least Squares Mean
92159|NCT00885118|Secondary|Change From Baseline in Fasting Insulin|Change from baseline in Fasting insulin to 28 days|baseline and 28 days|Full analysis set (FAS)||uU/mL||Standard Error|Least Squares Mean
92160|NCT00885118|Secondary|Change From Baseline in 1,5-anhydroglucitol|Change from baseline in 1,5-anhydroglucitol to 28 days|baseline and 28 days|Full analysis set (FAS)||ug/mL||Standard Error|Least Squares Mean
92161|NCT00885118|Secondary|Change From Baseline in Fructosamine|Change from baseline in Fructosamine to 28 days|baseline and 28 days|Full analysis set (FAS)||umol/L||Standard Error|Least Squares Mean
92162|NCT00885118|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c to 28 days|baseline and 28 days|Full analysis set (FAS)||percentage of HbA1c||Standard Error|Least Squares Mean
92163|NCT00885118|Primary|Change From Baseline in 8-point Glucose|Change from baseline in 8-point glucose to 27 days|baseline and 27 days|Full analysis set (FAS)||mg/dL||Standard Error|Least Squares Mean
92164|NCT00885118|Primary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose to 28 days|baseline and 28 days|Full analysis set (FAS)||mg/dL||Standard Error|Least Squares Mean
92165|NCT00885118|Primary|Change From Baseline in Urine Glucose Excretion|Change from baseline in Urine glucose excretion to 28 days|baseline and 28 days|Full analysis set (FAS)||mg||Standard Error|Least Squares Mean
92166|NCT00885105|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.|Days 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population||Percentage of Participants|||Number
92167|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Antibodies to polio viruses were measured by a serum neutralization assay.|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
92168|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
92169|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.|"Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).~Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.~The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay."|Day 28 Post-vaccination|GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
92170|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
92171|NCT00885105|Primary|Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.|Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
92172|NCT00885092|Secondary|Percentage of Participants With Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.||Percentage of participants|||Number
92219|NCT00884390|Secondary|Number of Participants With Breakthrough Bleeds|The number of participants with any breakthrough bleed was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||participants|||Number
92173|NCT00885092|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, My lenses feel comfortable right now, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.||Units on a scale||Standard Deviation|Mean
92174|NCT00885092|Primary|Mean Ex-Vivo Wetting Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.||Degrees||Standard Deviation|Mean
92175|NCT00885079|Primary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.|Baseline, Weeks4|||units on a scale||Standard Deviation|Mean
92176|NCT00885079|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups|Baseline, Weeks4|||units on a scale||Standard Deviation|Mean
92177|NCT00884949|Primary|Subject Incidence of Treatment Emergent AEs|"The primary objective of the study was to evaluate the safety of weekly infusions of BMN 110 administered in escalating doses to subjects with MPS IVA.~The safety variable incidence of TEAE is summarized."|Entire Study, through week 84|||participants|||Number
92178|NCT00884949|Secondary|Percent Change From Baseline in FVC|Percent Change from baseline in Forced Vital Capacity.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage of FVC||Standard Deviation|Mean
92179|NCT00884949|Secondary|Percent Change From Baseline in MVV|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage of MVV||Standard Deviation|Mean
92180|NCT00884949|Secondary|Percent Change From Baseline in uKS|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.||percentage of uKS||Standard Deviation|Mean
92181|NCT00884949|Secondary|Change From Baseline in 3MSCT|Change from baseline in the 3-minute Stair Climb Test. Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.||steps/min||Standard Deviation|Mean
92182|NCT00884949|Secondary|Change From Baseline in 6MWT|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.||meters||Standard Deviation|Mean
92183|NCT00884910|Primary|Patient Preference|"Patients were asked Which voice prosthesis do you prefer? Answer options were old one (Provox2), new one (Provox Vega 22.5), or no preference."|3 months post insertion, or at end of device life (whichever comes sooner)|All patients that participated in the study and finished it were analyzed||Patients|||Number
92184|NCT00884910|Secondary|Device Life Time|Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.|6 months|Six months after placement of the devices, 25 out of 33 had been replaced for leakage through the device. The median device life time is based on all 33 devices. The maximum of the range reflects the 6 months cut off and not the actual maximum device life time, because of the devices still in situ at the time of analysis.||Days||Full Range|Median
92185|NCT00884832|Secondary|Percentage of Days With FI Post-treatment Adjusted for Baseline|The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.|4 weeks treatment|||percentage of days||Standard Error|Mean
92186|NCT00884832|Secondary|Percentage of Days With Fecal Incontinence (FI)||4 weeks baseline, 4 weeks treatment|||percentage of days||Standard Error|Mean
92187|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline|The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.|4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
92188|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea|The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
92190|NCT00884832|Secondary|Satisfaction With Treatment|"This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = Not satisfied at all (no relief of symptoms) to 100 = Completely satisfied (symptoms resolved). The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods."|4 weeks baseline, 4 week treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
92191|NCT00884832|Secondary|Impact of Fecal Incontinence on Post-Treatment Quality of Life|"Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|after 4 weeks treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
92192|NCT00884832|Secondary|Impact of Fecal Incontinence on Baseline Quality of Life|"Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|4 weeks baseline|Intent to treat analysis||units on a scale||Standard Error|Mean
92193|NCT00884832|Secondary|Mean Severity of Fecal Incontinence|The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
92194|NCT00884832|Secondary|Mean Percentage of Bowel Movements Which Were Incontinent|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||percentage of bowel movements||Standard Error|Mean
92195|NCT00884832|Secondary|Mean Number of Fecal Incontinence Episodes|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||number of episodes||Standard Error|Mean
92196|NCT00884832|Secondary|Mean Number of Days With Fecal Incontinence|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||days||Standard Error|Mean
92197|NCT00884832|Primary|Mean Fecal Incontinence and Constipation Assessment (FICA) Score|The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1–6, 7–10, and 11–13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis||units on a scale||Standard Error|Mean
92198|NCT00884806|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, Over the previous 2-3 hours, my lenses felt comfortable, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7|Intent to treat: All participant who received regimen and had at least one on-therapy study visit.||Units on a scale||Standard Deviation|Mean
92199|NCT00884806|Primary|Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.|Day 7|Intent to treat: All participants who received regimen and had at least one on-therapy visit.||Percentage of participants|||Number
92200|NCT00884793|Secondary|"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"|Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry|12 weeks|All patients who had endoscopy at week 12.||percentage change||Standard Error|Mean
92201|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4% in the Ileum.|Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum|12 weeks|Includes all those who had endoscopy at week 12||participants|||Number
92202|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.|Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12.|12 weeks|Includes all with gut samples from week 12.||participants|||Number
92203|NCT00884793|Primary|Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum|Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum|12 weeks|We analyzed data from all subjects who had endosocopies at week 12.||participants|||Number
92204|NCT00884754|Primary|Time to Intubation (Seconds)||30-150 seconds (anticipated)|||seconds||Inter-Quartile Range|Median
92205|NCT00884741|Other Pre-specified|Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)||Analysis can occur at or after time of primary outcome measure analysis.||||||
92206|NCT00884741|Other Pre-specified|Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)||Analysis can occur at or after time of primary outcome measure analysis.||||||
92765|NCT00879775|Secondary|Health-related Quality of Life|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
92207|NCT00884741|Secondary|Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0|AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.|Up to 30 days|Eligible randomized patients with adverse event data who started study treatment.||participants|||Number
92208|NCT00884741|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients||months||95% Confidence Interval|Median
92209|NCT00884741|Primary|Overall Survival (OS)|Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients||months||95% Confidence Interval|Median
92210|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Punctate Corneal Staining Score|Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Baseline, Month 2|||Percentage of Patients|||Number
92211|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Composite Symptom Score|Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.|Baseline, Month 2|Intent to Treat: all randomized patients||Percentage of Patients|||Number
92212|NCT00884585|Secondary|Percentage of Punctate Corneal Staining Responders|Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Month 2|Intent to Treat: all randomized patients||Percentage of Patients|||Number
92213|NCT00884585|Primary|Percentage of Treatment Responders|Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).|Baseline, Month 2|Intent to Treat: all randomized patients||Percentage of Patients|||Number
92214|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the Prophylaxis Setting|The calculation of incidence of prophylaxis LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the Prophylactic LETE CRF), and the denominator was the number of routine prophylaxis infusions. Each infusion was classified in the infusion log (“Prophylaxis/ On Demand/ Preventive”), and participants were instructed to select “On Demand” if the infusion was to treat a bleed, even if the participant typically followed a prophylaxis regimen. Only the infusions classified as “Prophylaxis” were counted in this denominator.|100 exposure days to study medication (approx. 2 years)|||percentage of bleeding episodes||95% Confidence Interval|Number
92215|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting|The calculation of incidence of on-demand LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the On Demand LETE CRF), and the denominator was the number of bleeding episodes treated in an on-demand setting. This denominator could include new bleeding episodes in prophylaxis participants breakthrough bleeds), and if subsequent on-demand doses for such a bleed met the on-demand LETE criteria, then an on-demand LETE was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||percentage of bleeds LETE||95% Confidence Interval|Number
92216|NCT00884390|Secondary|Average Infusion Dose|The average infusion dose for each participant was calculated as his total factor consumption (in IU) divided by the number of infusions administered. Summary statistics were reported for both of these variables separately for those participants classified at baseline as following an on-demand regimen, and for those on a primary or secondary prophylaxis regimen.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||IU||Standard Deviation|Mean
92217|NCT00884390|Secondary|TFC Following a Prophylaxis Regimen at Baseline for All Participants|The total amount (in IU) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||IU||Standard Deviation|Mean
92218|NCT00884390|Secondary|Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants|The total amount (in International Units [IU]) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||International Units (IU)||Standard Deviation|Mean
92220|NCT00884390|Secondary|Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion|First, the bleed start time from the Infusion Log Diary CRF was used to determine the number of breakthrough bleeds that occurred ≤48 hours after an infusion marked as “Prophylaxis” (which had no associated bleed). If there was more than 1 bleed location (ie, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence. If a response was given, or if a bleed time was given, but “On Demand” was not listed as “treatment type”, it was still counted as an on-demand bleed for analyses/summaries. Bleeding episodes were not categorized as spontaneous (atraumatic) or traumatic.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||bleeds|||Number
92221|NCT00884390|Secondary|Number of ReFacto AF Infusions to Treat Each New Bleed|The Infusion Log Diary case report form (CRF) was used to determine the number of test article infusions administered to treat a bleed. This was calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time).|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of Infusions||Standard Deviation|Mean
92222|NCT00884390|Secondary|Response Assessment of First On-demand Treatment of New Bleeds|"A 4-point scale of assessment of ‘on-demand’ treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as:~Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered.~Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered.~Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode.~No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens."|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of observations|||Number
92223|NCT00884390|Secondary|Annualized Bleeding Rates (ABRs)|An ABR for each participant will be calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by his total therapy duration (in days), then multiplied by 365.25.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of bleeds||Standard Deviation|Mean
92224|NCT00884390|Primary|Number of Participants With Clinically Significant Factor VIII Inhibitor Development|Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.||Number of participants||95% Confidence Interval|Number
92225|NCT00884325|Secondary|Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30)|Baseline - Week 2 - Week 4|||units on a scale||Inter-Quartile Range|Median
92226|NCT00884325|Primary|Pruritus VAS Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.|Baseline - Week 2-Week 4|||units on a scale||Inter-Quartile Range|Median
92227|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).||milliliter||Standard Deviation|Mean
92228|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety Analysis Set.||participants|||Number
92229|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety Analysis Set.||participants|||Number
92230|NCT00884273|Secondary|Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)|The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.||scores on a scale||Standard Deviation|Mean
92231|NCT00884273|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.||scores on a scale||Standard Deviation|Mean
92232|NCT00884273|Secondary|Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.||nanograms per milliliter||Full Range|Median
92233|NCT00884273|Secondary|Change in Serum Testosterone Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.||nanograms per milliliter||Full Range|Median
92234|NCT00884273|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
92235|NCT00884273|Secondary|Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8|TRUS is a method of measuring the size of the prostate.|After treatment of 4 and 8 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).||milliliter||Standard Deviation|Mean
92236|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF).||milliliter||Standard Deviation|Mean
92237|NCT00884221|Secondary|Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
92238|NCT00884221|Secondary|Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
92239|NCT00884221|Secondary|Blastocyst Quality, Intention-to-treat (ITT) Analysis Set|"Blastocyst quality on day 5 was based on the blastocyst expansion and hatching status, inner cell mass grading and trophectoderm grading.~Excellent-quality blastocysts were defined as those with blastocyst expansion and hatching status 4, 5 or 6, inner cell mass grading A, and trophectoderm grading A or B. Good-quality blastocysts were defined as those with blastocyst expansion and hatching status 3, 4, 5 or 6, inner cell mass grading A or B, and trophectoderm grading A or B."|5 days after oocyte retrieval (120h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Number of blastocysts||Standard Deviation|Mean
92240|NCT00884221|Secondary|Fertilization, Intention-to-treat (ITT) Analysis Set|Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized. Fertilization was estimated as (Number of oocytes with 2 pronuclei / number of metaphase II oocytes)*100|1 day after oocyte retrieval (19 h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of metaphase II oocytes||Standard Deviation|Mean
92241|NCT00884221|Secondary|Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set|Oocyte retrieval took place 36h (± 2h) after hCG administration. At oocyte retrieval, the number of oocytes retrieved was recorded.|36 h after hCG|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Oocytes per participant||Standard Deviation|Mean
92242|NCT00884221|Secondary|Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set|During the controlled ovarian stimulation, transvaginal ultrasound was performed to count the number of follicles and measure the size of the follicles.|Last stimulation day|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Follicles per participant||Standard Deviation|Mean
92243|NCT00884221|Secondary|Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||nmol/L||Standard Deviation|Mean
92244|NCT00884221|Secondary|Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||nmol/L||Standard Deviation|Mean
92245|NCT00884221|Secondary|Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||pmol/L||Standard Deviation|Mean
92280|NCT00884065|Primary|Change in Active extensión Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)|||Sexagesimal degrees||Standard Deviation|Mean
92246|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The per-protocol (PP) analysis set was defined as all randomized and exposed participants except those excluded as a result of major protocol deviations, such as significant non-compliance or other serious unforeseen deviations deemed to invalidate the data and affect the conclusions of the trial.||Percentage of participants||Standard Deviation|Mean
92247|NCT00884221|Secondary|Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||nmol/L||Standard Deviation|Mean
92248|NCT00884221|Secondary|Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||IU/L||Standard Deviation|Mean
92249|NCT00884221|Secondary|Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn. Free androgen index = (testosterone (nmol/L)/ sex hormone binding globulin (nmol/L))*100|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
92250|NCT00884221|Secondary|Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||IU/L||Standard Deviation|Mean
92251|NCT00884221|Secondary|Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||pmol/L||Standard Deviation|Mean
92252|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.||Percentage of participants||Standard Deviation|Mean
92253|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.||degrees Celsius||Standard Deviation|Mean
92254|NCT00884117|Secondary|Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|"ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table."||degrees Celsius||Standard Deviation|Mean
92255|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.||degrees Celsius||Standard Deviation|Mean
92256|NCT00884117|Secondary|Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||degrees Celsius||Standard Deviation|Mean
92257|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||units on a scale||Standard Deviation|Mean
92258|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||units on a scale||Standard Deviation|Mean
92259|NCT00884117|Secondary|Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses.|Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data. The number of participants who provided evaluable data for each resistance status at Baseline (n) is shown in the table.||percentage of participants|||Number
92260|NCT00884117|Secondary|Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses.|Days 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the specified visit. The number of participants who provided evaluable data for each resistance status at the specified visit (n) is shown in the table.||percentage of participants|||Number
92261|NCT00884117|Secondary|Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses.|Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the Day 6 visit. The number of participants who provided evaluable data for each resistance status at the Day 6 visit (n) is shown in the table.||percentage of participants|||Number
92262|NCT00884117|Secondary|Viral Load Among Children Treated With Oseltamivir|Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL.|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||log10 vp/mL||Standard Deviation|Mean
92263|NCT00884117|Secondary|Viral Load Among Adults Treated With Oseltamivir|Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL).|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.||log10 vp/mL||Standard Deviation|Mean
92264|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with influenza B infection who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
92265|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
92279|NCT00884065|Primary|Change in Active External Rotation After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)|||Sexagesimal degrees||Standard Deviation|Mean
92266|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
92267|NCT00884117|Secondary|Time to Non-Detection of Viral RNA|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants who provided sufficient post-Baseline data.||days||95% Confidence Interval|Median
92268|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.||participants|||Number
92269|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.||participants|||Number
92270|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.||participants|||Number
92271|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.||participants|||Number
92272|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.||participants|||Number
92273|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.||participants|||Number
92274|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.||participants|||Number
92275|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.||participants|||Number
92276|NCT00884117|Primary|Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7|ALCIP Population. The “Number of Participants Analyzed” reflects combined H3N2 or H1N1pdm09-infected participants across all study years who provided an analyzable post-Baseline sample for their viral RNA subtype. The number of participants who provided evaluable data for each viral RNA subtype in the specified timeframe (n) is shown in the table.||percentage of participants|||Number
92277|NCT00884117|Primary|Number of Participants With Genotypic Resistance|"Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, H stands for hemagglutinin and N stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.)"|Baseline (Day 1) and post-Baseline (Days 3, 6, 10)|All Laboratory-Confirmed Influenza Participants (ALCIP) Population: All with confirmed influenza by positive RT-PCR at Baseline. The “Number of Participants Analyzed” reflects the total of participants who provided evaluable data for their viral RNA subtype. The number who provided data for each viral RNA subtype in each timeframe (n) is shown.||participants|||Number
92278|NCT00884065|Primary|Change in Active Internal Rotation After Intervention Minus Baseline|Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility|Baseline and the same day (just after intervention)|||Centimeters||Standard Deviation|Mean
92281|NCT00884065|Primary|Change in Active Abduction Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination|Baseline and the same day (just after intervention)|||Sexagesimal degrees||Standard Deviation|Mean
92282|NCT00884065|Primary|Change in Active Flexion Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)|||Sexagesimal Degrees||Standard Deviation|Mean
92283|NCT00884065|Secondary|Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline|An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.|Baseline and the same day (just after intervention)|||Millimeters||Standard Deviation|Mean
92284|NCT00884039|Primary|Change in Intraocular Pressure||1 week, 2 weeks, and monthly through 6 months after treatment||||||
92285|NCT00884039|Primary|Intraocular Pressure Within Normal Limits (<24 mm Hg)|Intraocular pressure was measured by Goldmann applanation tonometry.|1 month|Per protocol||Participants|||Number
92286|NCT00883779|Secondary|Median Follow-up Time During the Study|Median follow-up was calculated using 'Reverse Kaplan-Meier' analysis for Overall survival.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years])|FAS population.||months||95% Confidence Interval|Median
92287|NCT00883779|Secondary|Time to Deterioration in QOL Using FACT-L Version 4.0|"Time to deterioration in QoL is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in Total FACT-L or death on study. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||months||95% Confidence Interval|Median
92288|NCT00883779|Secondary|Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0|"Total FACT-L score was defined as the sum of the TOI, Social Well Being (SWB) and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||percentage of participants|||Number
92289|NCT00883779|Secondary|Time to Deterioration in TOI Using FACT-L Version 4.0|"Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. TOI is defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of QoL. A clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||months||95% Confidence Interval|Median
92290|NCT00883779|Secondary|Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0|"TOI was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of quality of life (QoL). A clinically meaningful decline used to determine deterioration in TOI was greater than or equal to (≥) 6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||percentage of participants|||Number
92320|NCT00883753|Secondary|Percentage of Participants With DAS28 Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission was defined as a DAS28 score < 2.6.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
92291|NCT00883779|Secondary|Time to Symptomatic Progression|"Time to symptomatic progression was the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. LCS scores were obtained from a 7-item questionnaire from the FACT-L (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||months||95% Confidence Interval|Mean
92292|NCT00883779|Secondary|Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.||percentage of participants|||Number
92293|NCT00883779|Secondary|Time to Progression|Time to progression is defined as the time between the date of randomization and the date of the first documented disease progression. Participants who have not progressed at the time of study completion (or data cut off) or who were lost to follow up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was latest. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Participants with no post baseline tumor assessments were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years])|FAS population.||months||95% Confidence Interval|Median
92294|NCT00883779|Secondary|Duration of Response|Duration of response is defined as the time between the date of first documented response (CR or PR, as determined by the RECIST criteria) and the date of first documented PD or death. Participants who did not progress or die after they had a confirmed response (CR or PR) were censored at the date of their last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was last. CR and PR are defined in Outcome Measure 7.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population participants who were responders (CR or PR).||months||95% Confidence Interval|Median
92295|NCT00883779|Secondary|Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||percentage of participants||95% Confidence Interval|Number
92296|NCT00883779|Secondary|Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||percentage of participants||95% Confidence Interval|Number
92297|NCT00883779|Secondary|Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups||Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."||percentage of participants|||Number
92298|NCT00883779|Secondary|Median Overall Survival (OS) Time-Overall and Among Different Subgroups|OS was defined as the time between the date of randomization and the date of death from any cause. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Participants with no post baseline information were censored at the time of randomization. OS among different subgroups of type of carcinoma, smoking habit, EGFR mutation type, KRAS mutation type, EGFR IHC test result type, and EGFR FISH result type. Analysis was performed using Kaplan-Meier method.|Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."||months||95% Confidence Interval|Median
92766|NCT00879775|Secondary|Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
92299|NCT00883779|Secondary|Median PFS Time Based on Different Subgroups|Tumor response was evaluated according to RECIST (version 1.0). PD was defined in outcome measure 1. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. PFS among different subgroups of type of carcinoma, smoking habit, epidermal growth factor receptor (EGFR) mutation type, KRAS mutation type, EGFR immunohistochemistry (IHC) test result type, and EGFR fluorescent in situ hybridization (FISH) result type.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|"FAS population. n is the number of participants evaluable under the specified category."||months||95% Confidence Interval|Median
92300|NCT00883779|Secondary|Percentage of Participants Alive and Free From Disease Progression|Tumor response was evaluated according to RECIST (version 1.0). PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||percentage of participants|||Number
92301|NCT00883779|Primary|Median Progression Free Survival (PFS) Time|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.||months||95% Confidence Interval|Median
92302|NCT00883753|Secondary|Change From Baseline in FACIT-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."||score on a scale||Standard Deviation|Mean
92303|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."||score on a scale||Standard Deviation|Mean
92304|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
92305|NCT00883753|Secondary|Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinical Remission is defined as a HAQ-DI score < 0.5.|Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
92344|NCT00883740|Secondary|Slow Wave Sleep (SWS)|SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Percentage of total sleep time||Standard Error|Least Squares Mean
92306|NCT00883753|Secondary|Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinically meaningful improvement is defined as a reduction from Baseline in the HAQ-DI score ≥ 0.2.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
92307|NCT00883753|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
92308|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 90 (ACR90) Response|ACR90 response is defined as a ≥ 90 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
92309|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 70 (ACR70) Response|ACR70 response is defined as a ≥ 70 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
92310|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) Response|ACR50 response is defined as a ≥ 50 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
92321|NCT00883753|Secondary|Percentage of Participants With DAS28 Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Low Disease Activity was defined as a score of < 3.2.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."||percentage of participants|||Number
92311|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR20) Response|ACR20 response was defined as a ≥ 20 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||percentage of participants|||Number
92312|NCT00883753|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."||mg/dL||Standard Deviation|Mean
92313|NCT00883753|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."||mm/hr||Standard Deviation|Mean
92314|NCT00883753|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity VAS|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||mm||Standard Deviation|Mean
92315|NCT00883753|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity VAS|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
92316|NCT00883753|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||mm||Standard Deviation|Mean
92317|NCT00883753|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||joint count||Standard Deviation|Mean
92318|NCT00883753|Secondary|Change From Baseline in Tender Joint Count|68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||joint count||Standard Deviation|Mean
92319|NCT00883753|Secondary|Change From Baseline in DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."||score on a scale||Standard Deviation|Mean
92322|NCT00883753|Secondary|Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Clinical meaningful improvement was defined as a ≥ 1.2 unit reduction in DAS28.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"Long Term Extension Intent-to-treat (LTE ITT) population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and the given time-point."||percentage of participants|||Number
92323|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Neutrophil Count During the Study|Blood samples were collected for a Neutrophil Count every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for Neutrophil Count during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.||participants|||Number
92324|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Total Cholesterol During the Study|Blood samples were collected for Total Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by worst value for Total Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.||participants|||Number
92325|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study|Blood samples were collected for LDL Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for LDL Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.||participants|||Number
92326|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for AST (SGOT) During the Study|Blood samples were collected for liver function test: Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) [AST (SGOT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for AST=40 Units/Liter. The number of participants categorized by worst value for AST(SGOT) during the study is reported: Normal (AST result is within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.||participants|||Number
92327|NCT00883753|Secondary|Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study|Blood samples were collected for liver function test: Alanine aminotransferase (serum glutamic-pyruvic transaminase) [ALT(SGPT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for ALT=55 Units/Liter. The number of participants categorized by the highest value for ALT/GPT during the study is reported: Normal (ALT result within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.||participants|||Number
92328|NCT00883753|Secondary|Percentage of Participants With AST Elevations > 3*ULN|Blood was collected for the Liver Function Test: Aspartate aminotransferase (AST) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 40 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
92329|NCT00883753|Secondary|Percentage of Participants With ALT Elevations > 3*ULN|Blood samples were collected for the Liver Function Test: Alanine aminotransferase (ALT) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 55 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
92330|NCT00883753|Secondary|Percentage of Participants With Adverse Events (AEs) of Special Interest|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Adverse Events of special interest for this study were: Infections (preferred term in the infection adverse event group term), Serious Infections (an infection that qualified as Serious Adverse Event), Infusion Reactions (occurred during infusion or within 24 hours of infusion), Major Cardiac AE (Myocardial Infarction/ Acute Coronary Syndrome), Stroke or Death.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
92331|NCT00883753|Secondary|Percentage of Participants With Marked Lipid Abnormalities|Fasting blood samples were collected for Lipids: Cholesterol, Triglyceride, High-density lipoprotein (HDL) Cholesterol, Low-density lipoprotein (LDL) Cholesterol every 12 weeks and at follow-up in the Extension study and were sent to a central laboratory for analysis. Lipid abnormalities were defined as a High Cholesterol, High Triglyceride, Low HDL Cholesterol and a High LDL Cholesterol that occurred at any time in the extension study.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
92332|NCT00883753|Secondary|Time to Discontinuation of Tocilizumab Treatment for Any Cause|Time in days from start of the Core Study Day 1 to discontinuation of tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE). Participants who did not experience discontinuation of tocilizumab treatment were censored.||days||95% Confidence Interval|Median
92333|NCT00883753|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Any Cause|Percentage of participants who discontinued treatment with tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
92334|NCT00883753|Secondary|Time to Withdrawal Due to an Adverse Event (AE)|Time to withdrawal was defined as the number of days from Core Study Day 1 to the first date of onset of the AE leading to discontinuation of tocilizumab.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension(LTE). Participants who did not experience an AE-related treatment discontinuation of tocilizumab were censored.||days||95% Confidence Interval|Median
92335|NCT00883753|Secondary|Percentage of Participants With Adverse Events Leading to Withdraw|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants|||Number
92336|NCT00883753|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. The percentage of participants with AEs and SAEs that occurred in the Extension Study grouped according to the number of disease-modifying anti-rheumatic drugs (DMARD) a participant was taking at Core Baseline is presented.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).||percentage of participants||95% Confidence Interval|Number
92337|NCT00883740|Secondary|Subjective Total Sleep Time (sTST)|sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF||Minutes||Standard Error|Least Squares Mean
92338|NCT00883740|Secondary|Subjective Wake After Sleep Onset (sWASO)|sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant’s daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF||Minutes||Standard Error|Least Squares Mean
92339|NCT00883740|Secondary|Daily Pain Score|Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores.|Daily up to Day 73 or ET|ITT; LOCF||Units on a scale||Standard Error|Least Squares Mean
92340|NCT00883740|Secondary|Latency of Sleep Onset (LSO)|LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant’s daily SSQ.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF||Minutes||Standard Error|Least Squares Mean
92341|NCT00883740|Secondary|Sleep Quality|Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; Last observation carried forward (LOCF)||Unit on a scale||Standard Error|Least Squares Mean
92342|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT||Units on a scale||Standard Error|Least Squares Mean
92343|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT; n: number of participants at specific time points||Units on a scale||Standard Error|Least Squares Mean
92345|NCT00883740|Secondary|WASO by Each Quarter of the Night|WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
92346|NCT00883740|Secondary|WASO by Hour of the Night|WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
92347|NCT00883740|Secondary|Latency to Persistent Sleep (LPS)|LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
92348|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 2)|NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Awakenings||Standard Error|Least Squares Mean
92349|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 1)|NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Awakenings||Standard Error|Least Squares Mean
92350|NCT00883740|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Percentage of time asleep||Standard Error|Least Squares Mean
92351|NCT00883740|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
92352|NCT00883740|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT||Minutes||Standard Error|Least Squares Mean
92353|NCT00883740|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation||Minutes||Standard Error|Least Squares Mean
92354|NCT00883740|Primary|Wake After Sleep Onset (WASO) at Weeks 5 and 11|WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]) on 2 consecutive nights divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)|Per Protocol Population (PP) = all randomized participants who received study medication at a dose of 300 or 450 mg/day and completed the study without any major protocol violations;||Minutes||Standard Error|Least Squares Mean
92355|NCT00883675|Primary|Febrile Neutropenia|The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.|2 months|Intent to treat||participants|||Number
92356|NCT00883558|Secondary|Number of Participants With Hypoglycemic Events|The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 29|Participants who received at least 1 dose of study drug.||participants|||Number
92357|NCT00883558|Secondary|Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring|Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.|Week 14 and Week 26|Participants that completed both treatment cycles with evaluable CGM data.||hours||Standard Deviation|Mean
92358|NCT00883558|Primary|Postprandial Glucose Excursion|A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.|Week 14 and Week 26|Participants who completed both treatment cycles with evaluable postprandial glucose data.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
92359|NCT00883493|Secondary|Treatment Satisfaction Questionnaire (TSQ) Scores.|"The 14-item TAQ questionnaire evaluates the patient’s overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.~Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||Scores on a scale||Standard Deviation|Mean
92360|NCT00883493|Secondary|Change in the Sheehan Disability Scale (SDS) Total Score.|"The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).~Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||scores on a scale||95% Confidence Interval|Mean
92361|NCT00883493|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.|"The mean change in (Q-LES-Q–Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).~The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||scores on a scale||Standard Deviation|Mean
92362|NCT00883493|Secondary|Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.|"The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.~PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality."|Baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.||Scores on a scale||95% Confidence Interval|Mean
92363|NCT00883493|Secondary|Change in Young Mania Rating Scale (YMRS) Total Score.|"The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient’s subjective report of his or hers clinical condition over the previous 48 hours.~The mean change in YMRS Total score reported was calculated as baseline - week 8.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).||scores on a scale||Standard Deviation|Mean
92364|NCT00883493|Secondary|Change in the Clinical Global Impression Severity (CGI-S) Score.|"The reported mean change in the CGI-S score was calculated as baseline - week 8.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).||scores on a scale||Standard Deviation|Mean
92365|NCT00883493|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).~The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as “anxious mood”, “tension” or “fears”. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max)."|baseline, 8 weeks|"The analysis population was Per Protocol (PP)."||scores on a scale||Standard Deviation|Mean
92366|NCT00883493|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|"The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).~HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression."|Baseline, 8 Weeks|"The analysis population was Per Protocol (PP)."||scores on a scale||Standard Deviation|Mean
92367|NCT00883493|Secondary|Response Rate for MADRS.|"Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|baseline, week 8|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.||percentage of participants|||Number
92378|NCT00883246|Secondary|Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)|Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.|1 year|Lesions in patients with claudication at baseline||percentage of lesions|Participants||Number
92368|NCT00883493|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|"The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks).~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 8 weeks|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.||scores on a scale||Standard Deviation|Mean
92369|NCT00883389|Primary|Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device.|"Qualitative questionnaire with primary assessment: How useful do you think the Med-alert device will be for future healthcare. Response recorded based on a Likert scale with response of 0 = not useful, 1 = somewhat useful, 2 = extremely useful"|3 months|||Likert scale||Inter-Quartile Range|Median
92370|NCT00883337|Secondary|Extension Treatment Period: ARR Poisson Regression Estimates|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of the standardized treatment durations.To account for the different treatment durations among participants, a Poisson Regression Model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 197 weeks)|ITT population.||relapses per year||95% Confidence Interval|Number
92371|NCT00883337|Secondary|Extension Treatment Period: Overview of AEs|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|Safety population. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||participants|||Number
92372|NCT00883337|Secondary|Core Treatment Period: Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"Safety population: all randomized and treated participants. Participants were considered according to the drug actually received.~The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group."||participants|||Number
92373|NCT00883337|Secondary|Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores|TSQM version 1.4 is an instrument to assess patients' satisfaction with medication. It consists of 13 questions that cover three dimensions (effectiveness, side effects and convenience) plus a global satisfaction question. Four scores ranging from 0 to 100 (extremely satisfied) are obtained. Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on TSQM score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction as factors).|48 weeks|ITT population.||units on a scale||Standard Error|Least Squares Mean
92374|NCT00883337|Secondary|Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|Baseline (before randomization) and 48 weeks|ITT population.||units on a scale||Standard Error|Least Squares Mean
92375|NCT00883337|Secondary|Core Treatment Period: Annualized Relapse Rate [ARR] - Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.||relapses per year||95% Confidence Interval|Number
92376|NCT00883337|Primary|Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints|"Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.||percent probability||95% Confidence Interval|Number
92377|NCT00883337|Primary|Core Treatment Period: Overview of Failures|"Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|Intent-to-treat population: all randomized participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||participants|||Number
92456|NCT00883090|Secondary|Laboratory Safety Parameters|Number of participants with clinically significant laboratory safety parameter values. The laboratory safety parameters measured included serum chemistries, hematology and urinalysis.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.||participants|||Number
92379|NCT00883246|Secondary|Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)|Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.|3 months|Patients with wounds at baseline who had wound assessment scores at baseline and at 3 months.||percentage of patients|||Number
92380|NCT00883246|Secondary|Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)|Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.|One Year|All claudicants.||percentage of patients|||Number
92381|NCT00883246|Secondary|Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment|One Year|All patients with CLI.||percentage of lesions|Participants||Number
92382|NCT00883246|Secondary|Secondary Patency (in Patients Treated for Claudication RCC 1-3)|Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.|One Year|All claudicants.||percentage of lesions|Participants||Number
92383|NCT00883246|Secondary|Ankle-Brachial Index (in All Patients Enrolled)|Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.|1 Year|All patients with compressible arteries and a baseline ABI < 0.9.||percentage of patients|||Number
92384|NCT00883246|Secondary|Rutherford Clinical Category (in All Patients Enrolled)|Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.|1 Year|All patients with RCC data at baseline and 1 year||percentage of patients|||Number
92385|NCT00883246|Secondary|Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)|WIQ Walking Distance Scores at Baseline and One Year are presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.|Baseline and 1 Year|All subjects treated for claudication RCC 1-3 with completed WIQ forms||units on a scale||Standard Deviation|Mean
92386|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).|One Year|||percentage of patients|||Number
92387|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).|30 Days|||percentage of patients|||Number
92388|NCT00883246|Secondary|Procedural Success (in All Patients Enrolled)|Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography|Immediately following use of the SilverHawk and adjunctive devices|All lesions with angiographic core lab assessment of residual stenosis at the end of the procedure were included||percentage of lesions|Participants||Number
92389|NCT00883246|Secondary|Device Success (in All Patients Enrolled)|Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions.|Immediately following use of the SilverHawk device|Lesions with core angiographic laboratory measurements of residual stenosis||percentage of Lesions|Participants||Number
92390|NCT00883246|Primary|Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 – 6) at time of enrollment.|One Year|||percentage of subjects|||Number
92391|NCT00883246|Primary|Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)|The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 – 3) at time of enrollment.|One year|Kaplan-Meier estimate of the freedom from loss of primary patency in lesions (N=743 lesions)||percentage of lesions|Participants||Number
92392|NCT00883233|Primary|Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.|Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.|Week 4|||Scores on a scale||Standard Deviation|Mean
92393|NCT00883181|Secondary|Number of Transfusions Per Participant in Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
92394|NCT00883181|Secondary|Number of Participants With Systemic Transfusions in Cycles 1 to 8|Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
92395|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment|The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.|9 weeks post initiation of ESA treatment|Participants who received treatment with an ESA||percentage of participants||95% Confidence Interval|Number
92396|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
92397|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
92398|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
92399|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 11 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
92400|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
92401|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin < 9 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
92402|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response|Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||percentage of participants||95% Confidence Interval|Number
92403|NCT00883181|Secondary|Change in Hemoglobin During ESA Treatment Phase||Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin measurements available at both time points.||g/dL||Standard Deviation|Mean
92404|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment|Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and still on study 5 weeks after initiation of ESA treatment.||percentage of participants||95% Confidence Interval|Number
92405|NCT00883181|Secondary|Number of Clinical Visits in Cycles 1-8 by ESA Use|The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||visits per month||Standard Deviation|Mean
92406|NCT00883181|Secondary|Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||participants|||Number
92407|NCT00883181|Secondary|Reason for Treatment With Erythropoiesis-stimulating Agents|The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||participants|||Number
92408|NCT00883181|Secondary|Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA||weeks||Standard Deviation|Mean
92457|NCT00883090|Secondary|Adverse Events|Number of participants with an adverse event|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.||participants|||Number
92409|NCT00883181|Secondary|Time to Disease Progression|Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.|From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.|Full analysis set||months||95% Confidence Interval|Median
92410|NCT00883181|Secondary|Number of Participants With Hematological Toxicities|The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
92411|NCT00883181|Secondary|Investigator Assessed Clinical Response at End of Treatment||End of treatment (approximately 24 weeks)|Full analysis set||participants|||Number
92412|NCT00883181|Secondary|Number of Participants With Unplanned Hospitalizations|Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
92413|NCT00883181|Secondary|Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8|Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
92414|NCT00883181|Secondary|Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned and with ≥ 15% chemotherapy dose reduction in any cycle.||cycles|Participants||Number
92415|NCT00883181|Secondary|Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy and had > 3 days delay in one or more cycles||cycles|Participants||Number
92416|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Reductions|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)||percentage of cycles|Participants||Number
92417|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Reductions|A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)||percentage of participants||95% Confidence Interval|Number
92418|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Delays|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 days)|Full analysis set participants who received more than 1 cycle of chemotherapy||percentage of cycles|Participants||Number
92419|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8|A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy||percentage of participants||95% Confidence Interval|Number
92420|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF||days||Standard Deviation|Mean
92421|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim||days||Standard Deviation|Mean
92422|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any other G-CSF||percentage of participants||95% Confidence Interval|Number
92423|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF||percentage of participants||95% Confidence Interval|Number
92424|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim||percentage of participants||95% Confidence Interval|Number
92425|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with other G-CSF||percentage of participants||95% Confidence Interval|Number
92426|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with other G-CSF||percentage of participants||95% Confidence Interval|Number
92427|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF.||days||Standard Deviation|Mean
92428|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim||days||Standard Deviation|Mean
92429|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF||days||Standard Deviation|Mean
92430|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim||days||Standard Deviation|Mean
92431|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF||percentage of participants||95% Confidence Interval|Number
92432|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim||percentage of participants||95% Confidence Interval|Number
92444|NCT00883129|Secondary|Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI asks questions related to 8 activity domains (dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities) with the patient's capacity to carry out each activity scored from 0 to 3. Scores across all domains are averaged and a higher score represents greater disability.|Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24|The analysis population contains all of those with data available at the defined time point.||HAQ-DI Total Score||Standard Deviation|Mean
92433|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF||percentage of participants||95% Confidence Interval|Number
92434|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim||percentage of participants||95% Confidence Interval|Number
92435|NCT00883181|Primary|Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received no prophylaxis or treatment with any G-CSF||percentage of participants||95% Confidence Interval|Number
92436|NCT00883181|Secondary|Number of Participants Who Received G-CSF During Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set||participants|||Number
92437|NCT00883181|Primary|Percentage of Participants With Febrile Neutropenia (FN)|Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm².|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set; Note: One participant with breast cancer had disease stage missing.||percentage of participants||95% Confidence Interval|Number
92438|NCT00883168|Secondary|Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to treat (ITT)population includes all subjects(18 years or older) who had at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
92439|NCT00883168|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|change from baseline in 12-hour instantaneous total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improved condition.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who received at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
92440|NCT00883168|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who had at least one post baseline dose efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
92441|NCT00883129|Secondary|Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.|The number of participants who remained in the study at the listed time points are reported|Continuous assessment from randomization to 24 months|||Participants|||Count of Participants
92442|NCT00883129|Secondary|Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death||Measured throughout the 2-year study|||Participants|||Count of Participants
92443|NCT00883129|Secondary|Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)|Skin thickness is quantified using the modified Rodnan measurement method (mRSS), with a scale that ranges from 0 (no skin involvement) to a maximum of 51. The reported skin score is determined by a clinical assessment of skin thickness, which is performed by a trained reader, and represents the sum of individual assessments that are made in each of 17 body areas. Each area is given a score in the range of 0-3 (0 = normal; 1= mild thickness; 2 = moderate; 3 = severe thickness). A higher score represents more severe skin involvement.|Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||mRSS score||95% Confidence Interval|Mean
92445|NCT00883129|Secondary|Transitional Dyspnea Index Score|Change in breathlessness was assessed using the Transitional Dyspnea Index, which compares current symptoms to those at baseline. Total score ranges from - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea.|Measured at Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||Transitional Dyspnea Index Score||95% Confidence Interval|Mean
92446|NCT00883129|Secondary|Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)|Imaging of the whole lung (WL) is performed using a volumetric high resolution computerized tomography (HRCT) scan, which is then analyzed using a computer algorithm to determine the percentage of overall pixels exhibiting features characteristic for quantitative lung fibrosis (QLF). Higher percentages for QLF-WL therefore represent greater involvement by lung fibrosis.|Measured at baseline and Month 24|Analysis was carried out in the subset of subjects that had measurable HRCT scans at both study entry and 24 months||% of lung exhibiting QLF||95% Confidence Interval|Mean
92447|NCT00883129|Secondary|Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||DLCO %-pred||95% Confidence Interval|Mean
92448|NCT00883129|Secondary|Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The TLC represents the total volume of air within the lung after taking the deepest breath possible and the TLC %-predicted represents the TLC expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The TLC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||TLC %-pred||95% Confidence Interval|Mean
92449|NCT00883129|Primary|Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The primary outcome is the course over time from baseline to 24 months for the FVC %-predicted. The FVC %-predicted represents the adjusted volume of air (adjusted as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity) that can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of lung involvement and disease severity.|Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure||FVC %-pred||95% Confidence Interval|Mean
92450|NCT00883116|Secondary|Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days|All participants who received at least 1 dose of ixabepilone||Participants|||Number
92451|NCT00883116|Secondary|Best Overall Response Rate|Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.|Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)|All randomized participants with measurable disease||Percentage of participants||95% Confidence Interval|Number
92452|NCT00883116|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.|Date of randomization to date of disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months|All participants with measurable disease at randomization||Months||95% Confidence Interval|Median
92453|NCT00883116|Primary|Overall Survival (OS)|Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.|Date of randomization to date of death or last date censored to up to approximately 26 months|All randomized participants||Months||95% Confidence Interval|Median
92454|NCT00883103|Primary|Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain|A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.|Immediately after the examination|All participants assigned to the lidocaine or aqueous gel groups were analyzed. There was no dropout or missing information.||Scores on a scale||Full Range|Median
92455|NCT00883090|Secondary|Vital Signs|Number of participants with clinically significant vital signs. The vital signs measured included blood pressure, pulse rate and temperature. Clinically significant changes in vital signs were to be reported as adverse events.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.||participants|||Number
92459|NCT00883090|Primary|Volume of Distribution at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||mL/kg||Standard Deviation|Mean
92460|NCT00883090|Primary|Clearance||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||mL/hr/kg||Standard Deviation|Mean
92461|NCT00883090|Primary|Area Under the Curve at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units*hr/mL||Standard Deviation|Mean
92462|NCT00883090|Primary|Terminal Half-life||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||days||Standard Deviation|Mean
92463|NCT00883090|Primary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as the maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of FXIII (U/kg) administered.|12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units/mL/Units/kg||Standard Deviation|Mean
92464|NCT00883090|Primary|Time to Peak Concentration||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||hr||Standard Deviation|Mean
92465|NCT00883090|Primary|Trough FXIII Concentration at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units/mL||Standard Deviation|Mean
92466|NCT00883090|Primary|Peak FXIII Concentration at Steady State||12 weeks|The analysis population was the pharmacokinetic (PK) population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).||Units/mL||Standard Deviation|Mean
92467|NCT00882921|Secondary|Change From Baseline in uGAG Levels to 109 Weeks|Urine GAG|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase. The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.||mcg/mg||Standard Deviation|Mean
92468|NCT00882921|Primary|Infusion-Related Adverse Event (IRAE) Rates Between IgG Anti-idursulfase Antibody Positive (Ab+) and Anti-idursulfase IgG Antibody Negative (Ab-) Patients|The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase.||IRAE/Week|||Number
92469|NCT00882908|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng*h/mL||Full Range|Median
92470|NCT00882908|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.||ng/mL||Full Range|Median
92471|NCT00882908|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.|Baseline (Day 1) up to Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Participants|||Number
92472|NCT00882908|Secondary|The Number of Participants With Viral Relapse|The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Participants|||Number
92473|NCT00882908|Secondary|Number of Participants With Viral Breakthrough|The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).|Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Participants|||Number
95145|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)||Baseline to Month 6 (or end of treatment)|FAS; LOCF.||percent of participants||95% Confidence Interval|Number
92474|NCT00882908|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.|Up to Week 36 or 52|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92475|NCT00882908|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92476|NCT00882908|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Baseline (Day 1) and Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92477|NCT00882908|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92478|NCT00882908|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.|Week 48 or 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92479|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.|Baseline (Day 1) and Weeks, 2, 4, 8, and 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92480|NCT00882908|Secondary|The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92481|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92482|NCT00882908|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.||Percentage of participants|||Number
92483|NCT00882778|Secondary|Number of Physician Reported Outcome Assessment in Prophylaxis in Percentage of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days||percentage of patients|||Number
92484|NCT00882778|Secondary|Physician Reported Outcome Assessment in Prophylaxis in Number of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days||patients|||Number
92485|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months.||change in days per month||Standard Deviation|Mean
92486|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis of approximately 6 months.||change in days per month||Standard Deviation|Mean
92487|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (RFVIIa) for at least 30 days.||change in days per month||Standard Deviation|Mean
92488|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||change in events per month||Standard Deviation|Mean
92489|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||change in events per month||Standard Deviation|Mean
92490|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations, and Hospital Admissions Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days||change in events per month||Standard Deviation|Mean
92491|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Frequent Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (= 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected in these patients. Bleed episodes with no recorded locations were not included in the analysis||percent change (%) in bleeds per month|||Number
92492|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (defined as 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected. Bleed episodes with no recorded locations were not included in the analysis||percent change (%) in bleeds per month|||Number
92493|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
92494|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
92495|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
92496|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
92497|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
92498|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||mcg/kg||Full Range|Median
92499|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92500|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92501|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92502|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92503|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92552|NCT00882310|Primary|Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)|"Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.~Data was not analyzed because original PI left institution before data analysis was completed."|At days 4, 11, and follow-up.||||||
92504|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92505|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92506|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92507|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Frequent Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92508|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92509|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Frequent Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92510|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months||percent change (%) in bleeds per month|||Number
92511|NCT00882713|Secondary|Mean Change From Baseline in Weight Over Time|Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).|Week 16 and Week 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.||kilogram||Standard Deviation|Mean
92512|NCT00882713|Secondary|Mean Change From Baseline in Blood Pressure Over Time|Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.||millimeter of mercury||Standard Deviation|Mean
92513|NCT00882713|Secondary|Mean Change From Baseline in Pulse Rate Over Time|Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.||beats per minute||Standard Deviation|Mean
92553|NCT00882206|Secondary|Level of Methylation||Day 33|||percentage of DNA||Standard Deviation|Mean
92554|NCT00882206|Secondary|Level of Methylation||Day 5|||percentage of DNA||Standard Deviation|Mean
92514|NCT00882713|Secondary|Mean Transferrin Saturation Levels Over Time|The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||Percentage of Transferrin Saturation||Standard Deviation|Mean
92515|NCT00882713|Secondary|Mean Ferritin Levels Over Time|The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||mcg/L||Standard Deviation|Mean
92516|NCT00882713|Secondary|Mean C-Reactive Protein Levels Over Time|The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||miligrams/L||Standard Deviation|Mean
92517|NCT00882713|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||micromole/L||Standard Deviation|Mean
92518|NCT00882713|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||milimole/L||Standard Deviation|Mean
92519|NCT00882713|Secondary|Mean White Blood Cells and Thrombocytes Over Time|The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||10^9 cells/L||Standard Deviation|Mean
92520|NCT00882713|Secondary|Mean Albumin Levels Over Time|The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not. Out of 194, one participant was excluded from the ITT population due to missing hemoglobin measurement and C.E.R.A medication after Week 0.||g/L||Standard Deviation|Mean
92521|NCT00882713|Secondary|Mean Hematocrit Levels Over Time|The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||Proportion of red blood cells in blood||Standard Deviation|Mean
92522|NCT00882713|Secondary|Mean Hemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.||g/dL||Standard Deviation|Mean
92523|NCT00882713|Secondary|Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.||Number of RBCs transfusion|||Number
92524|NCT00882713|Secondary|Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP|Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||Percentage of participants|||Number
92555|NCT00882206|Secondary|Level of Methylation||Day 0|||percentage of DNA||Standard Deviation|Mean
93153|NCT00875433|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as time from start of treatment to death.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.||weeks||95% Confidence Interval|Median
92525|NCT00882713|Secondary|Number of Participants With Any Adverse Events or Serious Adverse Events|An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
92526|NCT00882713|Secondary|Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP|Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||Days||Standard Deviation|Mean
92527|NCT00882713|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP|Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||Percentage of participants||95% Confidence Interval|Number
92528|NCT00882713|Secondary|Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period|Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.|SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.||g/dL||Standard Deviation|Mean
92529|NCT00882713|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period|The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.|EEP (Week 17 to Week 24)|The per-protocol (PP) population included all participants from the intention-to-treat (ITT) population, who fulfilled inclusion/exclusion criteria as per the study protocol. A total of 123 participants were included in the PP population.||Percentage of participants||95% Confidence Interval|Number
92530|NCT00882557|Secondary|Treatment-emergent Adverse Events|Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.|Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).|Safety population, defined as all subjects who received at least one dose of daptomycin||participants|||Number
92531|NCT00882557|Other Pre-specified|Volume of Distribution|Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.|Up to 68 hours post dose|||mL/kg||Full Range|Median
92532|NCT00882557|Other Pre-specified|Clearance of Daptomycin|Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.|Up to 68 hours post dose|PK Population - defined as all subjects who received both doses of daptomycin||mL/hr/kg||Full Range|Median
92533|NCT00882557|Other Pre-specified|Half-life|Apparent terminal half-life.|Up to 68 hours post dose|||Hours||Full Range|Median
92534|NCT00882557|Other Pre-specified|Time to Maximum Concentration|Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.|Up to 68 hours post dose|||Hours||Full Range|Median
92535|NCT00882557|Other Pre-specified|Maximum Plasma Concentration|Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|PK Population - defined as all subjects who received both doses of daptomycin||ug/mL||Full Range|Median
92536|NCT00882557|Primary|Evaluation of Area Under the Curve From Time 0 to Infinity|Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|The primary endpoints are measured on the PK population, defined as all subjects who received both the 6 mg/kg dose and 9 mg/kg dose||hr*ug/mL||Full Range|Median
92537|NCT00882518|Secondary|Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42|6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
92538|NCT00882518|Secondary|Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42|"6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least “minimally improved” at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient’s change from baseline CGI on a seven-point scale (1=”Very much improved”, 7=”Very much worse.)"|Baseline and 6 weeks|Full analysis set was used for secondary outcome||percentage of participants|||Number
92539|NCT00882518|Secondary|Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.~1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme."|Baseline and 6 weeks|Full analysis set was used for secondary outcome||Percentage of participants|||Number
92540|NCT00882518|Secondary|Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
92541|NCT00882518|Secondary|Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
92542|NCT00882518|Secondary|Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42|The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
92543|NCT00882518|Secondary|Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
92544|NCT00882518|Secondary|Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome||scores on a scale||Standard Error|Least Squares Mean
92545|NCT00882518|Primary|Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42|6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.|Baseline and 6 weeks|Per-protocol population was used as the analysis set for primary outcome, because this is a non-inferior design study.||scores on a scale||Standard Error|Least Squares Mean
92546|NCT00882440|Secondary|Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8||6 hours post dose at Baseline and 8 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
92547|NCT00882440|Primary|Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8||24 hours post dose at Baseline and Week 8|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||mm Hg||Standard Deviation|Mean
92548|NCT00882440|Secondary|Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8|"Patients in Category I (defined as excellent in protocol) if SuDBP was <90 mmHg, Category II (defined as good in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as fair or inadequate in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg."|24 hours post dose at Week 8|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."||Participants|||Number
92549|NCT00882362|Primary|Montgomery–Asberg Depression Rating Scale (MADRS)|"Change from baseline to Last Observation Carried Forward (LOCF).~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline(Day 1), Week52 or at discontinuation|||Rating Score||Standard Error|Mean
92550|NCT00882310|Secondary|Score on FACT-Hep (Version 4)|"Quality of life score of patients treated with the adjuvant GTX regimen using, the FACT-Hep (Version 4), a sensitive measure of quality of life.~Data was not analyzed because original PI left institution before data analysis was completed."|Prior to starting treatment, after 3 months of treatment, and at the end of study visit.||||||
92551|NCT00882310|Secondary|Time to Death|"Median recurrence free survival in patients with non-metastatic, resected pancreatic cancer treated with adjuvant GTX.~Data was not analyzed because original PI left institution before data analysis was completed."|At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.||||||
92556|NCT00882206|Primary|Response to Treatment|Response includes both complete remission (defined as <5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33)|Day 33|Two patients were considered mild protocol eligibility deviations because one was found in remission after one dose of study treatment, and the other was found to be in morphologic remission. The protocol requires morphologic evidence of disease with > 5% blasts.||participants|||Number
92557|NCT00882102|Primary|Number of Participants With a Complete Response|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).|Day 14 of first cycle|||Participants|||Number
92558|NCT00881959|Primary|Non –Inferiority of Dermis to Alloderm|Non –inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.|12 months|||mm||Standard Deviation|Mean
92559|NCT00881894|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)||mg||Standard Deviation|Mean
92560|NCT00881894|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||L/ h||Standard Deviation|Mean
92561|NCT00881894|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
92562|NCT00881894|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||1/ hour (1/h)||Standard Deviation|Mean
92563|NCT00881894|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Standard Deviation|Mean
92564|NCT00881894|Secondary|Tmax of Unconjugated Rotigotine|The Tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||hour (h)||Full Range|Median
92565|NCT00881894|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*kg||Standard Deviation|Mean
92566|NCT00881894|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL) / mg||Standard Deviation|Mean
92567|NCT00881894|Secondary|AUC(0-tz)Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h*kg||Standard Deviation|Mean
92568|NCT00881894|Secondary|AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
92569|NCT00881894|Secondary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
92570|NCT00881894|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)||ng/ mL||Standard Deviation|Mean
92571|NCT00881894|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application|Pharmacokinetic Set (PKS)||(ng/ mL)*h||Standard Deviation|Mean
92572|NCT00881868|Primary|Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)|Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).|baseline to week 4|ITT, LOCF||participants|||Number
92573|NCT00881868|Secondary|Number of Participants in Each Category of Pruritus at Baseline and Week 4|Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.|baseline to week 4|||participants|||Number
92574|NCT00881868|Secondary|Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4|Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.|baseline to week 4|||participants|||Number
92575|NCT00881868|Secondary|Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4|Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.|baseline to week 4|||participants|||Number
92576|NCT00881712|Secondary|Correlation of Functional CT-PET Imaging With Treatment Outcomes||Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years|This data was not collected as study was terminated early.|||||
92577|NCT00881712|Secondary|Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy||Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually|This data was not collected as study was terminated early.|||||
92578|NCT00881712|Secondary|Percentage of Patients Alive at 5 Years||Five years following radiation treatment|Thirteen enrolled patients that completed treatment.||percentage of patients|||Number
92579|NCT00881712|Secondary|Percentage of Patients With Disease Control|"Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.), as accurate."|Following treatment every 6 months for 2 years, then annually for 4 years.|Thirteen enrolled patients that completed treatment||percentage of participants|||Number
92580|NCT00881712|Primary|Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities||Six months after end of radiation therapy|||participants|||Number
92581|NCT00881647|Primary|Sleep Efficiency (SE)|SE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|||percentage of time||Standard Deviation|Mean
92582|NCT00881647|Primary|Minutes of Wake After Sleep Onset (WASO)|WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|per protocol||Minutes||Standard Deviation|Mean
92583|NCT00881647|Primary|Sleep Latency (SL)|In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|||minutes||Standard Deviation|Mean
92584|NCT00881608|Secondary|Duration of Vaginal Bleeding Following Treatment With Proellex.||At least 2 days|Study prematurely terminated|||||
92585|NCT00881608|Primary|Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.||An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses|Study prematurely terminated|||||
92586|NCT00881530|Primary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.|78 weeks plus 1 week of follow-up|Treated set||percentage of participants|||Number
92587|NCT00881530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||mg/dL||Standard Deviation|Mean
92588|NCT00881530|Secondary|Occurrence of a Relative Efficacy Response|Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of participants|||Number
92589|NCT00881530|Secondary|Occurrence of a Treat-to-target Response (HbA1c < 6.5%)|Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of participants|||Number
92590|NCT00881530|Secondary|Occurence of a Treat-to-target Response (HbA1c < 7.0%)|Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of participants|||Number
92591|NCT00881530|Secondary|Change From Baseline in HbA1c Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set||percentage of HbA1c||Standard Deviation|Mean
92592|NCT00881530|Primary|Change From Baseline to Week 78 in Lipid Parameters|Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)|Weeks 1 and 78|Treated set||mmol/L||Standard Deviation|Mean
92609|NCT00880919|Primary|Symptom Checklist -90-Revised (SCL-90-R)|90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms|Change in psychological problems and symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92593|NCT00881530|Primary|Hypoglycaemic Events|"Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration:~Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L)~Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L)~Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance~Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions"|78 weeks plus 1 week of follow-up|Treated set||percentage of participants|||Number
92594|NCT00881504|Secondary|Safety and Toxicity|The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.|8 weeks|||participants|||Number
92595|NCT00881504|Primary|Progression-free Survival|Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.|2 years|"Primary outcome of 4 participants out of 8 was undetermined due to several reasons including patient refusal of further follow up.~Of the 4 patients remaining for analysis, progression free survival of 34, 26.3, 7, and 4.7 weeks was seen."||weeks||Full Range|Median
92596|NCT00881465|Secondary|Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 (“Very Much Improved) and 7 (“Very Much Worse”).|Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.|within one week after treatment condition was concluded|||participants|||Number
92597|NCT00881465|Secondary|Clinical Global Impression – Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded|||units on a scale||Standard Deviation|Mean
92598|NCT00881465|Primary|Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index.|Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded|||units on a scale||Standard Deviation|Mean
92599|NCT00881335|Secondary|Number of Cases With Hospital Visit||up to 28 days|||participants|||Number
92600|NCT00881335|Primary|FEV1/FVC%, the Ratio of FEV1 to FVC|"indicators of pulmonary function,~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days|||ratios||Standard Deviation|Mean
92601|NCT00881335|Primary|FVC, Forced Vital Capacity|"indicators of pulmonary function, for example, FVC(unit of measurement:Liter)~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days|||L||Standard Deviation|Mean
92602|NCT00881335|Primary|FEV1, Forced Expiratory Volume at First Second|"indicators of pulmonary function, for example, FEV1(unit of measurement:Liter)~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days|||L||Standard Deviation|Mean
92603|NCT00881335|Primary|MPEF,Mean Peak Expiratory Flow|indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.|up to 28 days|||L/min||Standard Deviation|Mean
92604|NCT00881335|Secondary|Number of Cases With Antibiotics Therapy|antibiotics therapy is the indicators of pulmonary infection|up to 28 days|||participants|||Number
92605|NCT00881335|Primary|Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)||up to 28 days|||participants|||Number
92606|NCT00881205|Primary|Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population|The Selective Reminding Test(SRT) is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the patient should be in the testing room. A list of twelve words is read aloud by the examiner at a rate of one word per two seconds. The patient is asked to recall all twelve words. Only the words that are missed on the preceding trial are given in the consecutive trial. The total score represents a sum score of 6 trials, therefore the range is from 0-72. The lower the value the worse the outcome.|After 16 weeks of treatment|Due to low enrollment numbers study did not achieve the anticipated 80% power.||units on a scale||Standard Deviation|Mean
92607|NCT00880919|Primary|Sheehan Disability Scale (SDS)|Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment|Change in functional impairment from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92608|NCT00880919|Primary|Young Mania Rating Scale (YMS)|Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms|Change in manic symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92684|NCT00880191|Secondary|Comparison of Daily Complete Response Endpoints|Daily complete response is defined as no emetic episodes and no use of rescue therapy.|Days 1 through 6|||percentage of participants|||Number
92610|NCT00880919|Primary|Barratt Impulsiveness Scale (BIS)|30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.|Change in Impulsiveness from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92611|NCT00880919|Primary|Global Assessment of Functioning Scale (GAF)|Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional|Change in Global Assessment of Functioning from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92612|NCT00880919|Primary|Overt Aggression Scale - Modified (OAS-M)|Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.|Change from Baseline Overt Aggression Scale - Modified to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92613|NCT00880919|Primary|Borderline Evaluation of Severity Over Time (BEST)|Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).|Change in Borderline Evaluation of Severity Over Time from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92614|NCT00880919|Primary|Montgomery–Åsberg Depression Rating Scale (MADRS)|"Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression."|Change in severity of depressive episodes from baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Error|Mean
92615|NCT00880919|Primary|Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)|This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.|change in DSM-IV borderline psychopathology from baseline, weekly until week 8|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.||units on a scale||Standard Deviation|Mean
92616|NCT00880906|Secondary|Immunological Assessment Into the Etiology of Eosinophilic Esophagitis||60 days||||||
92617|NCT00880906|Primary|Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)|"Dysphagia Scores:~0 = able to eat normal diet / no dysphagia.~= able to swallow some solid foods~= able to swallow only semi solid foods~= able to swallow liquids only~= unable to swallow anything / total dysphagia"|60 days|||Percent Change|||Number
92618|NCT00880763|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
92619|NCT00880763|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.||Participants|||Number
92620|NCT00880763|Secondary|Change From Baseline in HCV RNA in log10 at Week 4|Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||IU/mL in Log10||Standard Deviation|Mean
92621|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percentage of participants|||Number
92622|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percentage of participants|||Number
93182|NCT00874770|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12|cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12|At Week 12|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
92623|NCT00880763|Primary|Percentage of Participants Achieving Rapid Viral Response|Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.|Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percentage of participants|||Number
92624|NCT00880750|Secondary|Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set||hours||Full Range|Median
92625|NCT00880750|Secondary|Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set||ng/ml||Standard Deviation|Mean
92626|NCT00880750|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|Pharmacokinetic set (PK) includes all subjects who had sufficient post-dose blood samples taken to estimate Cmax and AUC 0-48 hours after dosing on Day 4 in all treatment periods. Subjects who vomited between dosing and 10 hours post-dose on Day 4 of any treatment period were excluded from the PK set.||ng*h/ml||Standard Deviation|Mean
92627|NCT00880750|Secondary|Urinary Phosphate Excretion on Day 4||Continuous collection on Day 4|PD set||mmol||Standard Error|Least Squares Mean
92628|NCT00880750|Primary|Urinary Phosphate Excretion 3-Day Average||Continuous collection over 3 days|Pharmacodynamic Set (PD) includes all subjects who completed all urine collections and consumed at least 95% of food in all treatment periods. Subjects who vomited from days -2 to 4 of any treatment period were excluded from the set.||mmol||Standard Error|Least Squares Mean
92629|NCT00880698|Secondary|Number of Participants Classified at Screening or Entry as HIV-1 Uninfected, and Acquiring HIV-1 Infection on Study|HIV tests were done at screening, entry and the last study visit after the third vaccination. Any participants classified as HIV-1 uninfected at screening or entry but HIV-1 infected at their last study visit would be classified as acquiring HIV-1 infection during the study|From study entry until at least 42 days after third vaccination|Includes HIV-1 uninfected participants 'as-randomized' with an HIV test at entry and either 2 or 6 weeks after the third vaccination (or after the time point at which they would have received the third vaccination if they did not receive all three doses)||participants|||Number
92630|NCT00880698|Secondary|Change in CD4 Count From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-infected participants 'as randomized' with a CD4 count measurement prior to first vaccination and at their last study visit||cells/mm^3||Standard Deviation|Mean
92631|NCT00880698|Secondary|Change in CD4 Percent From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-1 infected participants 'as-randomized' with a CD4 percent measurement prior to first vaccination and at last study visit||Percentage of lymphocytes||Standard Deviation|Mean
92632|NCT00880698|Secondary|Percentage of HIV-1 Infected Participants With HIV-1 RNA <= 400 Copies/ml|Percentage of HIV-1 infected participants with HIV-1 RNA <= 400 copies/ml at last study visit|42 days after third vaccination or last study visit with an HIV-1 RNA measurement|Includes HIV-infected participants 'as-randomized' with an HIV-1 RNA measurement at their last study visit||Percentage of participants|||Number
92633|NCT00880698|Secondary|Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination|Number of participants with at least one positive enzyme immuno assay (EIA) rotavirus antigen test, positive fluorescent focal assay, and specific for rotavirus gene 6 which codes for the VP6 protein after each vaccination.|At entry, days 7, 14, 21 and 42 days after first dose, and at days 7 and 21 after the second and third doses|All participants 'as randomized'||participants|||Number
92634|NCT00880698|Primary|Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1.|Percentage of participants who experienced >=3-fold increases from prior to the first vaccination to at least 14 days after the third vaccination in Iga, SNA G1, SNA G2, SNA G3, SNA G4 and SNA P1.|Prior to first vaccination and at least 14 days after third vaccination|Only participants in the per-protocol population (received all 3 as-randomized vaccinations within recommended windows) and with measurements prior to the first vaccination and at least 11 days after the third vaccination and whose levels at the entry time point were less than one third of the upper limit of detection of the assay were included.||Percentage of participants||95% Confidence Interval|Number
92635|NCT00880698|Primary|Percentage of Participants Developing New Grade >=3 Adverse Events|Percentage of participants developing new grade >=3 adverse events (abnormal laboratory values (hematology and chemistry), signs, symptoms and diagnoses) not present at the time of the first vaccination. Adverse events were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 1.0, December 2004, Clarification August 2009).|From study entry until at least 42 days after third vaccination|Participants classified 'as'randomized'. Includes all follow-up on participants unblinded during the study and found to be on RotaTeq. Follow-up on participants unblinded during the study and found to be on placebo censored at the time of their last study vaccination.||Percentage of participants||95% Confidence Interval|Number
92636|NCT00880685|Secondary|Clinical Global Impression Severity Scales (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)|||units on a scale||Standard Deviation|Mean
92637|NCT00880685|Secondary|Kleptomania Symptom Assessment Scale (K-SAS)|Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)|||units on a scale||Standard Deviation|Mean
92638|NCT00880685|Primary|Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS)|Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The KM-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)|||units on a scale||Standard Deviation|Mean
92639|NCT00880620|Secondary|Safety||Week 30||||||
92640|NCT00880620|Secondary|Parkinson's Disease Questionnaire-39 (PDQ-39)|"Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Week 30 or early discontinuation. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of Never (better), Occasionally, Sometimes, Often, and Always (worse) in outcome."|Week 30||02/2016||||
92641|NCT00880620|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study).~Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|Week 30|Randomized Subjects||units on a scale||Standard Deviation|Mean
92642|NCT00880568|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event|This is a measure of the number of participants who experienced any adverse event (AE) while on study.|First dose up to 30 days after last dose (up to 2 years)|All participants on study||participants|||Number
92643|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.~AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4."|Cycle 1, Day 3 (Hour 0 through Hour 24)|All participants in the first 28-day cycle||hr*nmol/L||Standard Deviation|Mean
92644|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.~AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants in the first cycle of the 28-day dosing schedule||hr*nmol/L||Standard Deviation|Mean
92645|NCT00880568|Secondary|Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)|"AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle.~AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants on the 21-day dosing schedule||hr*nmol/L||Standard Deviation|Mean
92646|NCT00880568|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.|Cycle 1 (up to 21 or 28 days, depending on treatment arm)|All participants in the first cycle of each dosing schedule (21 or 28 days)||participants|||Number
92647|NCT00880555|Primary|FCI Score at Follow-up|At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.|Year 1, Year 2, Year 3|Individuals completing at least one assessment following baseline||points awarded for correct items||Standard Deviation|Mean
92648|NCT00880542|Secondary|Local and Distant Recurrence-free Survival||conclusion of study|Due to study closing early and the few number of participants enrolled, the outcome measures were not done.|||||
92649|NCT00880542|Primary|Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.|After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.|Participants were followed for duration of study, an average of 1 year.|Due to the study closing early and the few number of participants enrolled, the outcome measures were not done.|||||
92650|NCT00880425|Secondary|Number of Patient With Daily Headache Who Have Non-continuous Headache|Number of patient with Daily Headache who have non-continuous headache|Records were reviewed from April 2009 through June 2009|||participants|||Number
92651|NCT00880425|Primary|Number of Subjects With Daily Headache Who Have Continuous Headache|The number of subjects with Daily Headache who have continuous headache|Records were reviewed from April 2009 through June 2009|||participants|||Number
92652|NCT00880360|Secondary|Toxicity|Determine any toxicity associated with Ontak treatment in these patients.|3 years||||||
92653|NCT00880360|Primary|Number of Participants Demonstrating Clinical Response|Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.|2 years|Measurements performed by RECIST criteria and response reported as a percent. 56 subjects needed to be recruited to the study to determine efficacy. Analysis was on an intent to treat basis.||participants|||Number
92685|NCT00880191|Secondary|Level of Satisfaction for the Control of Nausea.|Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index – Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)|Days 1 through 6|203 patients in Gabapentin arm and 201 patients in Placebo arm submitted the data for this endpoint.||units on a scale||Standard Deviation|Mean
92654|NCT00880334|Post-Hoc|Disease Control Rate|Disease control rate is defined as the percentage of participants with confirmed overall Stable Disease (SD) or better using RECIST 1.0 criteria which parallels absence of disease progression (PD) on treatment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients without measurable disease only at baseline are included, based on status of non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|||percentage of participants||95% Confidence Interval|Number
92655|NCT00880334|Secondary|Objective Response Rate|Objective response rate is defined as the percentage of participants who achieved a confirmed overall partial response (PR) or complete response (CR) using RECIST criteria on treatment. Patients without measurable disease only at baseline are included, based on status of non-target lesions.Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.||percentage of participants||95% Confidence Interval|Number
92656|NCT00880334|Secondary|Median Overall Survival|Overall survival is defined from date of randomization to date of death or censored at the date the patient was last known alive.|Off treatment, patients were followed for survival information every 6 months (±1 month) until death,up to 2 years after discontinuing therapy, or until lost to follow-up. Median survival follow-up for the study cohort was 12 months (95% CI: 9-18 months).|The analysis dataset is comprised of all eligible and treated patients.||months||95% Confidence Interval|Median
92657|NCT00880334|Secondary|Grade 3-5 Toxicity Rate|Grade 3-5 toxicity rate is the percentage of participants experiencing maximum grade of all toxicity types of grade 3-5 with any attribution on treatment.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.||percentage of participants||95% Confidence Interval|Number
92658|NCT00880334|Primary|Median Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).|The analysis dataset is comprised of all eligible and treated patients.||months||95% Confidence Interval|Median
92659|NCT00880269|Secondary|Overall Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
92660|NCT00880269|Secondary|Event-free Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
92661|NCT00880269|Secondary|Duration of Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
92662|NCT00880269|Secondary|Time to Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
92663|NCT00880269|Secondary|Partial Response Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.|||||
92664|NCT00880269|Primary|Best Response as Per Investigator Assessment by Stratum (FAS)|This study followed Simon's optimal 2-stage design in each stratum, allowing the study to stop due to futility at the end of stage 1. The results of this endpoint determine the continuation of stage 2 of the study.|6 cycles of treatment with a 28-day treatment cycle (Day 168)|Full analysis set (FAS) is the same as the Safety set and includes all patients who received at least one dose of study drug. The FAS was used for final efficacy analyses.||Percentage of Participants|||Number
92665|NCT00880256|Secondary|Irritable Bowel Syndrome (IBS) Quality of Life|The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).|6 months|All participants who completed at 6 months were included||units on a scale||Standard Deviation|Mean
92686|NCT00880191|Secondary|Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses|The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.|Days 1 through 6|||units on a scale||Standard Deviation|Mean
92687|NCT00880191|Secondary|Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents|The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.|Days1 through 6|||percentage of participants|||Number
92666|NCT00880256|Primary|IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)|The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.|6 months|We compared scores at baseline, 2-month, and 6-month time points, using t-tests. A two-sided P value of less than 0.05 was considered statistically significant. The standardized mean difference (Cohen’s d effect size) from baseline to 2-months, and baseline to 6-months was calculated for each variable.||units on a scale||Standard Deviation|Mean
92667|NCT00880230|Secondary|Target Limb Loss|Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92668|NCT00880230|Secondary|Death|Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92669|NCT00880230|Secondary|Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months|||Percentage of Patients|||Number
92670|NCT00880230|Secondary|Target Limb Revascularization|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92671|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.|9 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92672|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.|9 Months|Intention to Treat (ITT)||Percentage of Patients|||Number
92673|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.|9 Months|Intention to Treat (ITT)||Percentage of Patients|||Number
92674|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.|6 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92675|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.|6 Months|Intention to Treat (ITT)||Percentage of Patients|||Number
92676|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.|6 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92677|NCT00880230|Secondary|Clinical Success|Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|9 Months|Intent to Treat Population (ITT)||Percentage of Patients|||Number
92678|NCT00880230|Secondary|Clinical Success|Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|6 Months|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92679|NCT00880230|Secondary|Clinical Success|Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.|30 Days|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92680|NCT00880230|Secondary|Procedural Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).|Up to the moment the catheter sheath introducer has been removed|Intention to Treat Population (ITT)||Percentage of Patients|||Number
92681|NCT00880230|Secondary|Device Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.|At time of deployment|Intent to Treat Population (ITT)||Percentage of Patients|||Number
92682|NCT00880230|Secondary|Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)|The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.|30 Days|Intent to Treat Population (ITT)||Percentage of Patients|||Number
92683|NCT00880230|Primary|Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.|The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.|In-hospital and 9 Months|Intent to Treat Population (ITT)||Percentage of Participants|||Number
92688|NCT00880191|Secondary|Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.|The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 1 through 6|||percentage of participants|||Number
92689|NCT00880191|Secondary|Complete Response|The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.|Days 2-6|||percentage of participants|||Number
92690|NCT00880191|Primary|Comparison of Percentage of Complete Responders|Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 2 through 6|||percentage of participants|||Number
92691|NCT00880165|Secondary|Continuous Positive Airway Pressure Adherence|Mean daily hours of use of continuous positive airway pressure over the 3 month intervention|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.||hours per day||Standard Deviation|Mean
92692|NCT00880165|Secondary|Functional Outcome of Sleep Questionnaire|Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.||units on a scale||Standard Deviation|Mean
92693|NCT00880165|Primary|Cost|VA sleep-study and treatment medical service use will be derived from the case report form; and costed out using VA acquisition costs. Other medical service use will be derived from VA administrative records. Non-VA medical service use will be derived from patient interview and will be costed out using federal reimbursement schedules. Costs will be stratified by whether or not they are related to the diagnosis and treatment of OSA.Cost and preferences are assessed for each entire arm.|Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.||dollars|||Number
92694|NCT00880100|Post-Hoc|Percentage of Patients With Control of Steatorrhea Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. There was no imputation of missing data. Here n signifies patients who were evaluable for each specific category."||percentage of patients||95% Confidence Interval|Number
92695|NCT00880100|Other Pre-specified|Percentage of Days With Abdominal Pain and Excessive Flatulence|Mean percentage of days with abdominal complaints during baseline phase (BP) and the 5-day collection period of the treatment phase for total patients was summarized. Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days abdominal pain (AP) and excessive flatulence (EF) in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specific category."||percentage of days||Standard Deviation|Mean
92696|NCT00880100|Other Pre-specified|Total Weight of Stools|The total weight of stools in grams (g) is the total weight obtained during the stool collection period regardless of the number of stools that had been collected during this same collection period. Mean total weight of stools in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here N (number of patients analyzed) represents number of patients who were evaluable for this outcome measure. Here n signifies patients who were evaluable for each specified category."||gram (g)||Standard Deviation|Mean
92697|NCT00880100|Secondary|Mean Number of Days Without Abdominal Complaints|Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days without abdominal complaints in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||days||Standard Deviation|Mean
92723|NCT00879970|Secondary|Number of Participants With a Fracture|Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92698|NCT00880100|Secondary|Percentage of Stools With Abnormal Characteristics|Stools of abnormal characteristics were defined as bulky/large, foul-smelling and/or oily stools. Mean percentage of stools with abnormal characteristics in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||percentage of stools||Standard Deviation|Mean
92699|NCT00880100|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as hard and formed or soft and formed consistency. Abnormal consistency was defined as loose and unformed stool or liquid stools and diarrhea. Percentage of stools with normal consistency of each patient was calculated from normal consistency of stools by the patient per day. Mean percentage of stools with normal consistency in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||percentage of stools||Standard Deviation|Mean
92700|NCT00880100|Secondary|Percentage of Patients With Normal Stool Frequency|Normal stool frequency was defined as having less than 4 bowel movements per day in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the Treatment Phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."||percentage of patients||95% Confidence Interval|Number
92701|NCT00880100|Primary|Percentage of Patients With Control of Steatorrhea|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected at baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and during the 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|The Intent-to-treat (ITT) population included all patients who signed an informed consent form (ICF) and started the baseline phase. The 50th percentile imputation method was used for missing data.||percentage of patients||95% Confidence Interval|Number
92702|NCT00880022|Secondary|Symptom Improvement||end of scheduled treatments-day 30 of treatment||||||
92703|NCT00880022|Primary|Arm Volume at End of Study|measured by tape and then volume was calculated.|end of scheduled treatments-day 30 of treatment|Study withdrawals were not included.||ml||Inter-Quartile Range|Median
92704|NCT00880009|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92705|NCT00880009|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92706|NCT00880009|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92707|NCT00880009|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92708|NCT00880009|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92709|NCT00880009|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 36 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92722|NCT00879970|Secondary|Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests|"Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. Liver function test abnormal and hepatic enzyme increased were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology. The vitamin D arm was not analyzed for this outcome measure."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92710|NCT00880009|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92711|NCT00880009|Secondary|Progression-Free Survival (PFS) Based on Investigator|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death). PFS assessed by investigator was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92712|NCT00880009|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after the last dose|Safety population included all participants who receive at least 1 dose of study treatment.||percentage of participants|||Number
92713|NCT00880009|Primary|Progression-Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PFS assessed by independent radiologist was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
92714|NCT00879996|Secondary|Self-reported Illicit Opioid Use||6 months|||number of participants|||Number
92715|NCT00879996|Secondary|Numerical Rating Score for Functioning|We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.|6 months|The participants who completed the treatment were included in the statistical analysis.||units on a 0-10 point NRS scale||Standard Deviation|Mean
92716|NCT00879996|Secondary|Numerical Rating Score for Pain|Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.|6 months|Participants that completed the treatment at 6 months were analyzed.||units on a 0-10 NRS scale||Standard Deviation|Mean
92717|NCT00879996|Primary|Number of Participants Retained in Treatment|This outcome assesses the number of participants who completed the treatment after 6 months.|6 months|All participants that were randomized were analyzed regarding their retention in treatment at 6 months.||participants|||Number
92718|NCT00879970|Secondary|Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF)|CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
92719|NCT00879970|Secondary|Mean Score on Euro-QoL (EQ)-5D|"Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from 0 to 1, whereby a score of 1 represents the best health state imaginable and 0 represents a health state equivalent to being dead. Negative states are those worse than being dead."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
92720|NCT00879970|Secondary|Number of Participants With Erectile Dysfunction|Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
92721|NCT00879970|Secondary|Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit|CD is equivalent to a difference of >=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit).|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.|||||
92742|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).||Baseline up to Month 7|||percentage of participants|||Number
92724|NCT00879970|Secondary|Number of Participants With Clinical Proteinuria|Clinical proteinuria is defined as a laboratory detection of urinary protein excretion > 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio >=300 milligrams/g; timed urine collection for albumin excretion >=200 µg/minute or >=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92725|NCT00879970|Secondary|Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia)|Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose <=36 mg/deciliter (2.0 millimole per liter [mmol/L]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92726|NCT00879970|Secondary|Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy|Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92727|NCT00879970|Secondary|Number of Participants With Composite Microvascular Outcome|The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92728|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina|CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92729|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Any Reason|Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92730|NCT00879970|Secondary|Number of Participants With Any Revascularization|Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92731|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D|An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population||participants|||Number
92732|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD)|An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).|From Randomization at Visit 3 up to the Final Visit (average of 162 days)|Intent-to-Treat (ITT) Population: all randomized participants||participants|||Number
92733|NCT00879879|Secondary|6-minute Walk Test Results||1 year||||||
92734|NCT00879879|Secondary|Baseline/Transition Dyspnea Index||1 year||||||
92735|NCT00879879|Secondary|Total Lung Capacity by Plethysmography||1 year||||||
92736|NCT00879879|Secondary|Diffusion Capacity of Carbon Monoxide (DLCO)||1 year||||||
92737|NCT00879879|Primary|Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year|"Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline.~Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment."|1 year|||participants|||Number
92738|NCT00879814|Secondary|Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)||Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3|||titers||95% Confidence Interval|Geometric Mean
92739|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).||Baseline up to Month 7|||percentage of participants|||Number
92740|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).||Baseline up to Month 7|||percentage of participants|||Number
92741|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).||Baseline up to Month 7|||percentage of participants|||Number
92767|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.|two days|intention to treat||scores|Participants|Standard Deviation|Mean
92768|NCT00879710|Secondary|Changes in Cholesterol Absorption or Synthesis Rates From the Baseline|We did not complete analyses of this outcome as we ran out of funds to measure these variables though samples have been collected.|6 weeks after initiation of drug therapy||||||
92769|NCT00879710|Primary|Changes in LDL Cholesterol|"Subjects with T1DM or T2DM were assigned to alternating therapy with simvastatin (40 mg) or ezetimibe (10 mg) for 6 weeks in a crossover design.~The data are reported as follows.~Subjects with type 1 diabetes mellitus:~Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)~Subjects with type 2 diabetes mellitus:~Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)"|6 weeks after starting drug therapy|||mmol/L||Standard Error|Mean
92770|NCT00879697|Primary|Total Walking Distance|The maximal walking distance|12 weeks|||meter||Standard Deviation|Mean
92771|NCT00879684|Secondary|Number of Participants With Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.|Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)|Safety population included all enrolled participants in the study who received any study medication.||participants|||Number
92772|NCT00879684|Secondary|Number of Samples From Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||samples|Participants||Number
92773|NCT00879684|Secondary|Number of Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||participants|||Number
92774|NCT00879684|Secondary|Recommended Phase 2 Dose (RP2D): Stage 1|RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.|Baseline (Day 0) up to 42 days after the last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.||(mg/kg)/week|||Number
92775|NCT00879684|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||hours||Full Range|Median
92776|NCT00879684|Secondary|Apparent Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||(mL/hr)/kg||Standard Deviation|Geometric Mean
92777|NCT00879684|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||milliliter per kilogram (mL/kg)||Standard Deviation|Geometric Mean
92778|NCT00879684|Secondary|Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]|AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
92779|NCT00879684|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||hours||Standard Deviation|Mean
92780|NCT00879684|Secondary|Maximum Observed Serum Concentration (Cmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
92805|NCT00879398|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment|The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.||Number of Episodes per 24 Hours||Standard Deviation|Mean
92917|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 1|||mmHg||Standard Error|Least Squares Mean
92781|NCT00879684|Primary|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline (Day 0) up to 30 days after last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.||participants|||Number
92782|NCT00879645|Secondary|Exhaled Sulfide||Baseline through day 2||||||
92783|NCT00879645|Secondary|Creatinine Clearance||Baseline, Day 7||||||
92784|NCT00879645|Secondary|Biochemistry||Baseline, Days 1, 2, and 7||||||
92785|NCT00879645|Secondary|Coagulation Factors||Baseline, Day 1, 2, and 7||||||
92786|NCT00879645|Secondary|12-lead ECG||Baseline, Day 0 through 7||||||
92787|NCT00879645|Secondary|Hematology||Baseline, Days 1 and 2||||||
92788|NCT00879645|Secondary|Urinalysis||Baseline, Days 1, 2, and 7||||||
92789|NCT00879645|Secondary|Vital Signs||Study duration||||||
92790|NCT00879645|Primary|Sodium Sulfide in Blood|Total concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.|8 hours after treatment|||ng/mL||Standard Deviation|Mean
92791|NCT00879645|Primary|Thiosulfate in Urine|Total concentration of thiosulfate in urine was measure through pharmacokinetic urine collection|48 hours after treatment|||ng/mL||Standard Deviation|Mean
92792|NCT00879645|Primary|Thiosulfate in Plasma|Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.|8 hours after treatment|||ng/mL||Standard Deviation|Mean
92793|NCT00879619|Secondary|Qualitative and Quantitative Toxicity|Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Categorical analysis of toxicities will be performed.|Every 3 weeks and at study termination||||||
92794|NCT00879619|Secondary|Survival|Quantitative Kaplan-Meyer estimates of progression-free survival and overall survival will be determined.|At 2 and 3 years||||||
92795|NCT00879619|Secondary|Time to Progression (TTP) by PSA Response and Disease Response|Defined as an absolute increase in PSA of at least 2 ng/ml. For subjects with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years||||||
92796|NCT00879619|Secondary|Duration of Response (DR)|Response rates will be expressed with two-sided exact binomial confidence intervals.|Up to 3 years||||||
92797|NCT00879619|Secondary|Rates of Tumor Response (ORR)|Response rates will be expressed with two-sided exact binomial confidence intervals. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher’s exact test. Associations between PSA response and tumor response will also be examined by Fisher’s exact test.|Every 2 months||||||
92798|NCT00879619|Primary|Prostate Specific Antigen (PSA) Response Rate|Defined by >= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher’s exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years||||||
92799|NCT00879411|Secondary|Overall Tolerability Scale|Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10|8 weeks|||units on a scale||Standard Deviation|Mean
92800|NCT00879411|Primary|Efficacy (Change of Diastolic Blood Pressure)|Change from baseline in 24h diastolic blood pressure (BP) at week 8|baseline to 8 weeks|||mm Hg||Standard Deviation|Mean
92801|NCT00879411|Primary|Efficacy (Change of Systolic Blood Pressure)|Change from baseline in 24h systolic blood pressure (BP) at week 8|baseline to 8 weeks|Intention to Treat (ITT)||mm Hg||Standard Deviation|Mean
92802|NCT00879398|Secondary|Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics|Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as “effective”. Baseline and treatment characteristics included: geriatric status (<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (<274 days and ≥274 days) .|At the end of study treatment|PP Population||Percentage of Participants||95% Confidence Interval|Number
92803|NCT00879398|Secondary|Participant Perception of Bladder Condition at the End of Study Treatment|Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.|Baseline and at the end of study treatment|PP Population||Participants|||Number
92804|NCT00879398|Secondary|Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment|The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.||Number of Episodes per 24 Hours||Standard Deviation|Mean
92827|NCT00879229|Secondary|Long-term Survival|Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.|Week 48|Full Analysis Set||percent probability (KM% estimate)||95% Confidence Interval|Number
92806|NCT00879398|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment|The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.||Number of Episodes per 24 Hours||Standard Deviation|Mean
92807|NCT00879398|Primary|Investigator's Final Assessment of Effectiveness at the End of Study Treatment|The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).|At the end of study treatment|Per-Protocol (PP) Population: participants who had evaluable data and were eligible for the efficacy assessment of the approved indication. The method of last observation carried forward was used in the analysis of effectiveness endpoints.||Percentage of Participants|||Number
92808|NCT00879398|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.|Safety Analysis Set||Percentage of Participants|||Number
92809|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.||ng/mL||Standard Deviation|Mean
92810|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.||ng/mL||Standard Deviation|Mean
92811|NCT00879333|Secondary|Overall Response Rate (ORR)|ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Participants|||Number
92812|NCT00879333|Secondary|Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
92813|NCT00879333|Secondary|Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores|The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss).|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
92828|NCT00879229|Primary|Change From Baseline in Six-minute Walk Distance (6MWD).|The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.|Baseline to Week 16|Participants in the Full Analysis Set (randomized and received at least one dose of study medication) with evaluable data were analyzed.||meters||Standard Error|Mean
92814|NCT00879333|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
92815|NCT00879333|Primary|Overall Survival (OS)|The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.||Months||95% Confidence Interval|Median
92816|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.|6 months post-treatment|||units on a scale||Standard Error|Mean
92817|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|3-month Post-treatment|||units on a scale||Standard Error|Mean
92818|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|Post-treatment (two-weeks following end of treatment)|||units on a scale||Standard Error|Mean
92819|NCT00879229|Secondary|Change in QOL Score as Assessed by the St. George’s Respiratory Questionnaire (SRGQ)|The SRGQ is designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.|Baseline to Week 16|Insufficient data due to study termination|||||
92820|NCT00879229|Secondary|Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)|Each SF-36 score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. An increase in score indicates an improvement in health state.|Baseline to Week 16|Insufficient data due to study termination|||||
92821|NCT00879229|Secondary|Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination|||||
92822|NCT00879229|Secondary|Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 16|Insufficient data due to study termination|||||
92823|NCT00879229|Secondary|Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.|Baseline to Week 16|Insufficient data due to study termination|||||
92824|NCT00879229|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted|FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination|||||
92825|NCT00879229|Secondary|Change From Baseline in WHO Functional Class|"WHO functional class rates severity of pulmonary hypertension, with 4 categories on a scale of 1 to 4 with the worst category being 4. Change is represented as an increase (+1: Improved), decrease (-1: Deteriorated), or no change (0: No change) on the scale."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.||units on a scale|||Number
92826|NCT00879229|Secondary|Transition Dyspnea Index (TDI)|"The change in TDI at Week 16 (end of blinded treatment) was evaluated. TDI measures the change from the baseline characteristic Baseline Dyspnea Index. The TDI range is -9 to +9 (worst to best; 0 = no change)."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.||units on a scale||Standard Deviation|Mean
92829|NCT00878969|Primary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|baseline and 18 months|Based on our power calculations, we needed 210 subjects to complete the study to be able to detect an effect. Given that only 37 subjects completed the study (18% of goal), no formal analyses were performed. Specifically, data were not collected for this assessment for any of the participants enrolled in the study.|||||
92830|NCT00878878|Primary|Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.||Wood Units||Standard Deviation|Mean
92831|NCT00878878|Secondary|Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.|"Observe subjects with normal pulmonary artery systolic pressure (PASP) and elevated pulmonary artery systolic pressure (PASP) as measured by any adverse events.~The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; 11 subjects that were Normal PASP and 19 subjects that were Elevated PASP.~This is per sequence and not a cross-over study."|During the injection and catheterization procedure, and for up to 24 hours post-injection|The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP.||Adverse Events|||Number
92832|NCT00878878|Primary|Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.||mm Hg||Standard Deviation|Mean
92833|NCT00878826|Secondary|Side Effect - Bruising||Enrollment through 6 weeks postpartum|||participants|||Number
92834|NCT00878826|Secondary|Bleeding Events||Enrollment through 6 weeks postpartum|||participants|||Number
92835|NCT00878826|Secondary|Thromboembolic Events||Enrollment through 6 weeks postpartum|||participants|||Number
92836|NCT00878826|Primary|Peak Anti-Xa Level|Goal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.|One measurement per trimester of pregnancy, up to 36 weeks|||u/ml||Standard Deviation|Mean
92837|NCT00878800|Secondary|Belinostat t½|Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.||hours||Geometric Coefficient of Variation|Geometric Mean
92838|NCT00878800|Secondary|Belinostat Cmax|Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
92839|NCT00878800|Secondary|Belinostat AUC (Time 0 to Last Measurement)|Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
92840|NCT00878800|Primary|Objective Response (CR and PR)|Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment.|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.||percentage of participants|||Number
92841|NCT00878800|Primary|Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment|Throughout study|||Dose limiting toxicity|||Number
92842|NCT00878800|Secondary|Disease Control Rate (CR or PR or SD)|The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.||percentage of participants|||Number
92843|NCT00878800|Secondary|Time to Progression||Throughout study, after every 2 cycles|Includes only patients with disease progression.||months||95% Confidence Interval|Median
92844|NCT00878800|Secondary|Duration of Response||Throughout study, after every 2 cycles|Includes only patients with response||Months||95% Confidence Interval|Median
92845|NCT00878800|Secondary|Time to Response||Throughout study, after every 2 cycles|Includes all 41 patients in the FAS population. 37 patients were censored due to no response, 23 in the Dose Escalation group and 14 in the MTD Expansion group.||months||Full Range|Median
92850|NCT00878722|Secondary|Belinostat Cmax|Cmax: Arm A: at Cycle 1 Day 4, Cycle 1 Day 5 Arm B: Cycle 1 Day 1 and Cycle 1 Day 2|Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d||ng/mL||Standard Deviation|Mean
92851|NCT00878722|Secondary|Remission Duration|Remission duration: time (weeks) from date of remission status to disease relapse.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Remission duration was reported among participants who reported response||Weeks||95% Confidence Interval|Mean
92852|NCT00878722|Secondary|Event-Free Survival|Event-free survival: time (weeks) from entry into study until treatment failure, disease relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle|||Weeks||95% Confidence Interval|Median
92853|NCT00878722|Secondary|Relapse-Free Survival|Relapse-free survival: time (weeks) from leukemia-free state to relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Relapse free survival was reported among participants who reported response||Weeks|||Number
92854|NCT00878722|Secondary|Overall Survival|Overall survival: time in weeks from entry into study until death from any cause. All patients without this endpoint at the time of discontinuation or the end of trial have been censored.|Throughout study, after each cycle for the first two cycles, then after every second cycle|||Weeks||95% Confidence Interval|Median
92855|NCT00878722|Secondary|Duration of Response (CR and PR)|Duration of Response (CR and PR) in Weeks|Throughout study, after each cycle for the first two cycles, then after every second cycle|All patients who received at least one dose of belinostat and/or idarubicin were included in the full analysis set (FAS). Duration of response was reported among participants who reported response||weeks||Full Range|Mean
92856|NCT00878722|Secondary|Time to Response (CR and PR)|Time to response: time in weeks from first treatment to obtainment of the particular response status (CR and PR)|Throughout study, after each cycle for the first two cycles, then after every second cycle|Time to response was reported among participants who reported response||Weeks||95% Confidence Interval|Median
92857|NCT00878722|Primary|Overall Response|Efficacy measured as Response rate (complete response ([CR] and Complete remission with incomplete recovery of platelets [CRi]) and partial response ([PR])) using the response criteria of the International Working Group (Cheson et al 2003). CR includes CRi, CRc (Cytogenetic complete remission), and CRm (Molecular complete remission).|Throughout study, after each cycle for the first two cycles, then after every second cycle|||participants|||Number
92858|NCT00878722|Primary|Maximum Tolerated Dose, Dose Limiting Toxicity|DLT (dose limiting toxicities): patients with any of the toxicities: 1.Haematological toxicity is not included in the definition due to bone marrow involvement by the disease except for following grade 4 ANC (absolute neutrophil count) and PLT (platelet count) for 6 weeks with less than 5% blasts in bone marrow. 2.Drug related non hematological Grade 3 or 4 toxicity except alopecia, brief nausea and vomiting, diarrhea, rash, arthralgias and myalgias. Treatment interventions should palliate toxicity symptoms prior to concluding a DLT has occurred (e.g if nausea and vomiting to Grade 3 have been associated with the drug). If despite standard treatment Grade 3 nausea and or vomiting persisted then a DLT was considered to have occurred. Grade 4 diarrhea in spite of standard therapeutic measures was included in DLT definition. 3.Inability to tolerate full dosing cycle due to toxicity or any drug-related adverse event resulting in more than 14 day treatment delay in the next treatment cycle|First Cycle|||participants|||Number
92859|NCT00878605|Primary|Hemoglobin A1C|% change HgbA1c from baseline to 12 weeks.|Baseline and Week 12||||||
92860|NCT00878553|Secondary|Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the plasma Half-Life (t1/2 in hours) of SKP-1041 zaleplon the each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA)for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||hour|Participants|Standard Error|Mean
92861|NCT00878553|Secondary|AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC/Dose (ng*h/mL/mg) [Area under the concentration-time curve per Dose of SKP-1041 zaleplon] for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng*h/mL/mg|Participants|Standard Error|Mean
92862|NCT00878553|Secondary|AUC Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC (area under the concentration-time curve of SKP-1041 zaleplon) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics were calculated for AUC. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng x h/mL|Participants|Standard Error|Mean
92918|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 2|||mmHg||Standard Error|Least Squares Mean
92863|NCT00878553|Secondary|Tmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Tmax (hour) (timepoint post-dose of maximum plasma zaleplon concentration) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||Hours post-dose|Participants|Standard Error|Mean
92864|NCT00878553|Secondary|Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Cmax/Dose (ng/mL/mg) (maximum plasma zaleplon concentration normalized per dose) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics, geometric means and 90% confidence intervals were calculated for dose-normalized values of Cmax. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng/mL/mg zaleplon|Participants|Standard Error|Mean
92865|NCT00878553|Secondary|Cmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the Cmax (maximum plasma concentration of SKP-1041 zaleplon in ng/mL) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).||ng/mL|Participants|Standard Error|Mean
92866|NCT00878553|Secondary|Visual Analog Scale (Sedation)|"Self-assessment of next morning sedation. Patients answered the question How alert do you feel? via a 100mm scale on which 0mm indicated very sleepy and 100mm indicated wide awake and alert.The VAS measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (in this case, sleepiness and alertness). Patients were asked to mark the point on the line that they felt represented their current state. The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked."|9 hours after tablet ingestion|Safety population (patients exposed to that given treatment)||mm change from baseline||Standard Error|Mean
92867|NCT00878553|Secondary|Digit Span Test|Assessment of next day residual cognitive effects via testing immediate recall of numbers. The patient was given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score was the number of correct responses, where the digits were repeated correctly. One point was given for each correctly repeated string of digits. The maximum subscore in the Digits Forward was 16, and the maximum subscore in the Digits Backward was 14, for a total score of 30.|9 hours post-dose|Intention to Treat population (all randomized patients)||units on a scale change from baseline||Standard Error|Mean
92868|NCT00878553|Secondary|Digit Symbol Substitution Test|Assessment of next-day residual cognitive effects. The Digit Symbol Substitution Test (DSST) explores attention and psychomotor speed. Given a code table displaying the correspondence between pairs of digits (from 1 to 9) and symbols, the patient filled in blank squares with the symbol that was paired with the digit displayed above the square. The patient was required to fill in as many squares as possible in 180 seconds.|9 hours after tablet ingestion|Intention to Treat population (all randomized patients)||percentage change from mean baseline||Standard Error|Mean
92869|NCT00878553|Secondary|Subjective Wake Time After Sleep Onset (sWASO)|Subjective wake time after sleep onset sourced from the Morning Sleep Questionnaire self-assessment|9 hours after tablet ingestion|All Efficacy Analyses were performed on the Intention to Treat (ITT) population (all randomized patients).||minutes||Standard Error|Mean
92870|NCT00878553|Secondary|Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)|Number of Awakenings After Sleep Onset during hours 3-7 post-dose (inclusive) as measured with PSG (polysomnography)|hours 3-7 (inclusive) post-dose|Intention to Treat dataset (all randomized patients)||Number of awakenings||Standard Error|Mean
92871|NCT00878553|Secondary|Total Sleep Time 3-7 Hours Post-dose|Total Sleep Time during hours 3-7 (inclusive) post-dose|hours 3-7 (inclusive) post-dose|Intention to Treat population (all randomized patients)||Minutes||Standard Error|Mean
92872|NCT00878553|Secondary|WASO 1-8|Wake Time After Sleep Onset, measured in minutes over the full 8 hour polysomnographic recording period, is summarized by treatment group for each night during the Screening and Treatment Periods.|Constantly throughout the 8 hour sleep period|Intention to Treat population||Minutes||Standard Error|Mean
92873|NCT00878553|Primary|Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)|Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.|Hours 3-7 (inclusive) after tablet ingestion|Efficacy analyses were performed on the Intention to Treat Population(all randomized patients).||minutes||Standard Error|Mean
92919|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 4|||mmHg||Standard Error|Least Squares Mean
92874|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. It consists of a pain subscale (5 questions), function subscale (17 questions). and a stiffness subscale (2 questions). The total score was derived by calculating the mean of the VAS scores from all 24 questions with score scale ranging from 0 to 100, 0 being no pain, stiffness and difficulty in performing daily activities and 100 being extreme pain, stiffness and difficulty in performing daily activities.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
92875|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. The Stiffness subscale consists of 2 questions (Severity of stiffness after first awakening in the morning and severity of stiffnes after periods of inactivity later in the day). WOMAC stiffness was derived by calculating the mean of the VAS scores from the 2 questions with score scale ranging from 0 to 100, 0 being no stiffness and 100 extreme stiffness.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
92876|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.|The WOMAC VA 3.1. is a self-administered electronic questionnaire that assesses pain, stiffness and disability related to OA. The Function (daily activities) subscale consists of 17 questions. WOMAC function was derived by calculating the mean of the VAS scores from the 17 questions with scores ranging from 0 to 100, 0 = no difficulty in performing daily activities and 100 = extreme difficulty.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
92877|NCT00878501|Primary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.|The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.|Baseline, week 2, week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.||mm||95% Confidence Interval|Least Squares Mean
92878|NCT00878228|Secondary|Impact of Nausea and Vomiting on Quality of Life|Percentage of participants whose quality of life was impacted by nausea and vomiting|Postdischarge Day 1|||percentage of participants|||Number
92879|NCT00878228|Secondary|Severity of Nausea|Percentage of participants reporting moderate or severe nausea in the first 24 hours|Postdischarge Day 1|||percentage of participants|||Number
92880|NCT00878228|Primary|Incidence of Nausea|Percentage of participants with nausea|Postdischarge Day 1|||percentage of participants|||Number
92881|NCT00877929|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)|Change from baseline in UACR (measured in spot urine) after eight weeks of treatment|8 weeks|Treated set||ratio||Standard Deviation|Mean
92882|NCT00877929|Secondary|DBP Response at Week One|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 1|Treated set||participants|||Number
92883|NCT00877929|Secondary|DBP Response at Week Two|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 2|Treated set||participants|||Number
92884|NCT00877929|Secondary|DBP Response at Week Four|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 4|Treated set||participants|||Number
92885|NCT00877929|Secondary|DBP Response at Six Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|week 6|Treated set||participants|||Number
92886|NCT00877929|Secondary|DBP Response at Eight Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|Week 8|Treated set||participants|||Number
92887|NCT00877929|Secondary|SBP Response 130 at One Week|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
92888|NCT00877929|Secondary|SBP Response 130 at Two Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
92889|NCT00877929|Secondary|SBP Response 130 at Four Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
92890|NCT00877929|Secondary|SBP Response 130 at Six Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
92891|NCT00877929|Secondary|SBP Response 130 at Eight Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
92892|NCT00877929|Secondary|SBP Response 140 at One Week|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
92893|NCT00877929|Secondary|SBP Response 140 at Two Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
92894|NCT00877929|Secondary|SBP Response 140 at Four Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF||participants|||Number
92895|NCT00877929|Secondary|SBP Response 140 at Six Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF||participants|||Number
92896|NCT00877929|Secondary|SBP Response 140 at Eight Weeks|SBP < 140 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF||participants|||Number
92897|NCT00877929|Secondary|SBP Control 130 at One Week|Mean seated SBP < 130 mmHg|Baseline, week 1|Treated set using LOCF||participants|||Number
92898|NCT00877929|Secondary|SBP Control 130 at Two Weeks|Mean seated SBP < 130 mmHg|Baseline, week 2|Treated set using LOCF||participants|||Number
92920|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 6|||mmHg||Standard Error|Least Squares Mean
92921|NCT00877929|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 8|Treated Set includes all randomized participants who took at least one dose of treatment||mmHg||Standard Error|Least Squares Mean
92922|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.||rate per subject-year||Standard Error|Mean
92923|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.||rate per subject-year||Standard Error|Mean
92924|NCT00877890|Secondary|Ratio of Triglycerides at Week 24 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||Standard Error|Least Squares Mean
92925|NCT00877890|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 24|Change in HDL from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
92926|NCT00877890|Secondary|Change in Total Cholesterol From Baseline to Week 24|Change in total cholesterol from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
92927|NCT00877890|Secondary|Change in Sitting Diastolic Blood Pressure From Baseline to Week 24|Change in diastolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
92928|NCT00877890|Secondary|Change in Sitting Systolic Blood Pressure From Baseline to Week 24|Change in systolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
92929|NCT00877890|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||Standard Error|Least Squares Mean
92930|NCT00877890|Secondary|Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL|Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
92931|NCT00877890|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|Change in fasting plasma glucose from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
92932|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
92933|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
92934|NCT00877890|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline].|Day 1, Week 24|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 24 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||Standard Error|Least Squares Mean
92935|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 to Month 120|||Subjects|||Number
92936|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 to Month 108|||Subjects|||Number
92937|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 to Month 96|||Subjects|||Number
92938|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 to Month 84|Analysis was performed on the Month 84 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 84 time point.||Subjects|||Number
92939|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 60 to Month 72|Analysis was performed on the Month 72 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 72 time point.||Subjects|||Number
92940|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 to Month 60|The analysis was performed on the Month 60 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 60 time point.||Subjects|||Number
92941|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.||Subjects|||Number
92942|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
92943|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 108|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.||EL.U/ML||95% Confidence Interval|Geometric Mean
92944|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 108|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.||Subjects|||Number
92945|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
92946|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
92947|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
92948|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
92949|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.||Subjects|||Number
92950|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.||Subjects|||Number
92951|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.||Subjects|||Number
92952|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.||Subjects|||Number
92953|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment||8 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 8-16 hour time interval.||mg||Standard Deviation|Mean
92954|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment||4 to 8 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 4-8 hour time interval.||mg||Standard Deviation|Mean
92955|NCT00877799|Secondary|Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment||0 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.||mg||Standard Deviation|Mean
92956|NCT00877799|Primary|Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint|The primary efficacy endpoint was the percentage of treatment responders compared to placebo. A responder was defined as a subject who had at least a 40% reduction in their pain intensity score and a pain relief score of “some,” “a lot,” or “complete” at 15 and 30 min following the start of the study drug infusion.|15 and 30 minutes after study drug administration|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.||responders|||Number
92957|NCT00877773|Primary|Tumor Response|For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).|Baseline to Disease Progression (restaged at 8 weeks and at 4 months)|Of the 44 participants enrolled, only 30 were evaluable for response.||participants|||Number
92958|NCT00877604|Secondary|Medical Research Council Scores for Right and Left Muscle Groups||1 year||||||
92959|NCT00877604|Secondary|Incidence and Severity of Adverse Events, and Their Relationship to Treatment|laboratory tests, patients’ reports and the investigator’s judgments|1 year||||||
92960|NCT00877604|Secondary|ALSFRS-R at Study End||1 year||||||
92961|NCT00877604|Secondary|Survival Time From Starting of Study Medication Dosing (if Appropriate)||1 year||||||
92962|NCT00877604|Secondary|Time to Tracheostomy From Starting of Study Medication Dosing (if Appropriate)||1 year||||||
92963|NCT00877604|Secondary|SF-36 Quality of Life Rating Scale||1 year||||||
92964|NCT00877604|Secondary|Forced Vital Capacity (FVC) %||1 year||||||
93096|NCT00875810|Secondary|Intervertebral Disc Space||2 years|As this is an observational study not all patients had images available for each visit, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.||millimiters||Standard Deviation|Mean
92965|NCT00877604|Primary|The Proportion of Responder Patients in the Two Treatment Groups According the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)-R Slope.|Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R slope during the treatment period as compared to the lead-in period.|1 year|||participants|||Number
92966|NCT00877487|Primary|Percent of Treatment Failures at up to 6 Weeks|Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.|Up to 6 weeks|Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product.||Percent of participants|||Number
92967|NCT00877487|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 6 weeks|FAS||Percent of Participants|||Number
92968|NCT00877487|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Up to 6 weeks|FAS||Units on a scale||Standard Error|Least Squares Mean
92969|NCT00877448|Primary|Treatment-related Adverse Events|Number of treatment-related adverse events per cohort|Day 0 until day 42 (termination visit)|||number of reported events|||Number
92970|NCT00877448|Primary|Adverse Events|Number of adverse events per cohort|day 0 until day 42 (termination visit)|||number of reported events|||Number
92971|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
92972|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
92973|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
92974|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
92975|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|End of the study (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
92976|NCT00877383|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
92977|NCT00877370|Primary|Ertapenem Transmembrane Clearance by Continuous Hemodialysis.||24 hours after receiving first 1 gram dose|All participants were included in the analysis.||mL/min||Standard Deviation|Mean
96365|NCT00845676|Primary|Sustained Virologic Response (SVR)|Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment|24 weeks|||percentage of participants|||Number
92978|NCT00875017|Secondary|Net Calcium Absorption|"Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting).~Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting).~Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting)."|10 hours post-dose|PD set||mg||Standard Error|Least Squares Mean
92979|NCT00875017|Secondary|Net Phosphorous Binding|"Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only.~Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only."|10 hours post-dose|PD set||mg||Standard Error|Least Squares Mean
92980|NCT00875017|Primary|Net Phosphorous Absorption|"Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting).~Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting).~Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting)."|10 hours post-dose|Pharmacodynamic Set (PD) consists of subjects who provided all rectal effluent collections and completed all treatment periods. Subjects who vomited during any of the treatment periods were excluded from the PD set.||mg||Standard Error|Least Squares Mean
92981|NCT00877071|Secondary|The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
92982|NCT00877071|Secondary|Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
92983|NCT00877071|Secondary|The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
92984|NCT00877071|Primary|The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM|Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.|36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.|||||
92985|NCT00877058|Primary|Self Rated Health|"Self rated health was measured by the question In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed"|1 year|ITT||participants|||Number
92986|NCT00877058|Primary|Number of Partipants Measured Frail at 1-year Follow up|Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition|1 year|ITT was used. The basic assumption was that older adults (80+) deteriorate over time in the natural course of the aging process. The imputation method chosen was to replace missing values with a value based on the Median Change of Deterioration (MCD) a conservative form of worst case between baseline and follow-up.||participants|||Number
92987|NCT00877058|Primary|Dependence in Two or More Activities of Daily Living (ADL)|"ADL stair case:~Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0–9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed"|1 year|||participants|||Number
92988|NCT00877032|Secondary|Number of Participants With Anti-Drug Anti-body|Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.||participants|||Number
92989|NCT00877032|Secondary|Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)|AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.||nanogram*hr/mL (ng*hr/mL)||Standard Deviation|Mean
92990|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.||hours||Full Range|Median
92991|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacodynamic (PD) analysis population included all participants who received any amount of the single dose of either study drug or placebo.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
92992|NCT00877032|Secondary|Plasma Terminal Half-life (t1/2) of RN6G|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||days||Standard Deviation|Mean
92993|NCT00877032|Secondary|Mean Residence Time (MRT) of RN6G|MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||days||Standard Deviation|Mean
92994|NCT00877032|Secondary|Clearance (CL) of RN6G|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||mL/hr/kg||Standard Deviation|Mean
92995|NCT00877032|Secondary|Volume of Distribution (Vd) of RN6G|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||mL/kilogram (mL/kg)||Standard Deviation|Mean
92996|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.||hours||Full Range|Median
92997|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.||mcg/mL||Standard Deviation|Mean
92998|NCT00877032|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.||mcg*hr/mL||Standard Deviation|Mean
92999|NCT00877032|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacokinetic (PK) analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
93000|NCT00877032|Primary|Incidence and Severity of Systemic Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.||participants|||Number
93001|NCT00877032|Primary|Incidence and Severity of Ocular Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.||participants|||Number
93002|NCT00877006|Secondary|Median Duration of Response at End of Follow-up||286 weeks (5.5 years)||07/2017||||
93003|NCT00877006|Secondary|Overall Survival at End of Follow-up||286 weeks (5.5 years)||07/2017||||
93004|NCT00877006|Secondary|Progression-free Survival and Event-free Survival at End of Follow-up||286 weeks (5.5 years)||07/2017||||
93005|NCT00877006|Secondary|Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life.|Day 1 (prior to treatment), 32 weeks|The set of randomized participants (intent-to-treat) consisting of all patients randomly assigned to treatment, and who had data at both timepoints.||units on a scale||Standard Deviation|Mean
93006|NCT00877006|Secondary|Therapeutic Classification of Concomitant Medications||32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.||participants|||Number
93007|NCT00877006|Secondary|Therapeutic Classification of Prior Medications||prior to start of treatment|Safety Analysis Set: all participants randomly assigned to a treatment group||participants|||Number
93008|NCT00877006|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period|Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status).|Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and with baseline and post-baseline values.||participants|||Number
93009|NCT00877006|Secondary|Potentially Clinically Significant Abnormal Weight|Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant.|Baseline, Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen with a baseline and post-baseline weight.||participants|||Number
93010|NCT00877006|Secondary|Clinically Significant Abnormal Vital Signs||32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and had baseline and post-baseline values.||participants|||Number
93011|NCT00877006|Secondary|Worst Overall CTCAE Grade for Hematology Laboratory Test Results|Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had an assessment.||participants|||Number
93012|NCT00877006|Secondary|Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results|Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had a post-baseline assessment.||participants|||Number
93013|NCT00877006|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period|AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one’s ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event.|32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.||participants|||Number
93014|NCT00877006|Secondary|Percentage of Participants With Overall Response at End of Treatment Period|Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
93028|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.||U/L||Standard Deviation|Mean
93970|NCT00866034|Other Pre-specified|Endocrine Profile in the Early, Mid and Late Follicular Phase.|"difference in endocrine profile between the 2 arms during the mid and late follicular phase~influence of early elevated follicular phase progesterone levels on clinical outcome"|2 years||||||
93015|NCT00877006|Primary|Percentage of Participants With Complete Response (CR) at End of Treatment Period|CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
93016|NCT00876928|Secondary|Disposition Index|Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better|Baseline, 3, 6, 9, 12 months|modified intent to treat||Unitless||Standard Deviation|Mean
93017|NCT00876928|Primary|Percent of Subjects Who Develop Diabetes|Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl|one year|Minorities with pre-diabetes and hypovitaminosis D||percentage of participants|||Number
93018|NCT00876915|Secondary|The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TAT at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TAT|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||ug/L||Standard Deviation|Mean
93019|NCT00876915|Secondary|The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of FVIIa at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of FVIIa|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||pM||Standard Deviation|Mean
93020|NCT00876915|Secondary|The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TFPI at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TFPI|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||pg/mL||Standard Deviation|Mean
93021|NCT00876915|Secondary|The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Human F12 at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of Human F12|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||ng/mL||Standard Deviation|Mean
93022|NCT00876915|Secondary|The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of D-Dimer at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of D-Dimer|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||ug/mL||Standard Deviation|Mean
93023|NCT00876915|Secondary|The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Tissue Factor at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients.|baseline value of tissue factor|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.||pg/mL||Standard Deviation|Mean
93024|NCT00876915|Primary|Percentage of Patients Who Experienced Clinically Significant Bleeding Events.|The percentage of patients who experienced a clinically significant bleeding event were recorded (including major and clinically significant non-major bleeding) over 13 weeks (12 weeks of study and an additional week of observation). Major bleeding was defined as being clinically overt and satisfying one of the following: decrease in hemoglobin of 2.0 g/dL, leading to transfusion of 2 or more units of blood or packed red cells, occurring in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leading to death. Clinically significant non-major bleeding was defined as clinically overt, not meeting criteria for major bleeding and with one of the following characteristics: multiple-source, spontaneous hematoma > 25 cm², epistaxis > 5 mins, macroscopic hematuria not related to instrumentation, spontaneous rectal bleeding, gingival bleeding > 5 mins, hemoptysis, hematemesis or prolonged bleeding (> 5 minutes) after venipuncture.|13 weeks|||percentage of participants|||Number
93025|NCT00876915|Primary|Percentage of Patients With Venous Thromboembolisms|The percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT.|12 weeks|||percentage of participants|||Number
93026|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.||g/dL||Standard Deviation|Mean
93027|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.||mg/dL||Standard Deviation|Mean
93094|NCT00875836|Secondary|Retention in the Study|Number of days subjects remained active in the study|participants were followed for twelve weeks|||Day||Inter-Quartile Range|Median
93971|NCT00866034|Secondary|Cumulative Ongoing Pregnancy Rate||2 years|||cumulative ongoing pregnancy rate (%)|||Number
93029|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for AST at baseline and at month 36.||U/L||Standard Deviation|Mean
93030|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.||U/L||Standard Deviation|Mean
93031|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.||mg/dL||Standard Deviation|Mean
93032|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 36.||mg/dL||Standard Deviation|Mean
93033|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
93034|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
93035|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.||mg/dL||Standard Deviation|Mean
93036|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.||g/dL||Standard Deviation|Mean
93037|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.||mg/dL||Standard Deviation|Mean
93038|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 12.||U/L||Standard Deviation|Mean
93039|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 12 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for AST at baseline and at month 12.||U/L||Standard Deviation|Mean
93040|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 12 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for ALT at baseline and at month 12.||U/L||Standard Deviation|Mean
93041|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.||mg/dL||Standard Deviation|Mean
93042|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 12.||mg/dL||Standard Deviation|Mean
93095|NCT00875836|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|Participants provided a once-weekly urine sample for twelve weeks|||percentage of UDS|Participants||Number
93043|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.||mg/dL||Standard Deviation|Mean
93044|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.||mg/dL||Standard Deviation|Mean
93045|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.||mg/dL||Standard Deviation|Mean
93046|NCT00876733|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline.|The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.||cells/mm^3||Standard Deviation|Mean
93047|NCT00876733|Secondary|Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.|The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 12 months|Patients from FAS with values for CD4+ at baseline and after 12 months.||cells/mm^3||Standard Deviation|Mean
93048|NCT00876733|Secondary|Changes in the Viral Load After 36 Months From Baseline.|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.||Log10 copies/ml||Standard Deviation|Mean
93049|NCT00876733|Secondary|Changes in the Viral Load After 12 Months From Baseline.|The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 12 months|Patients from FAS with values for viral load at baseline and after 12 months.||Log10 copies/ml||Standard Deviation|Mean
93050|NCT00876733|Primary|Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs|Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.||participants|||Number
93051|NCT00876694|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks|Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.|After 12, 24 and 52 weeks|The intention-to-treat (ITT) population included all randomized patients who received at least one dose of study drug.||Liters||Standard Error|Least Squares Mean
93052|NCT00876694|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.||mmol/L||Standard Error|Least Squares Mean
93053|NCT00876694|Primary|Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.||mmol/L||Standard Error|Least Squares Mean
93054|NCT00876694|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.~The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).~Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
93055|NCT00876694|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.~A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
93056|NCT00876694|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.~A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
93057|NCT00876694|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment|The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.|52 weeks|The safety population included all patients who received at least one dose of study drug.||Participants|||Number
93058|NCT00876460|Secondary|Cmax of Docetaxel in Course 2|"Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2.~Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
93059|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 2|"AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2.~Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (AUC0-inf could not be calculated in 1 patient because the elimination phase was not observed in plasma concentration-time profile in this patient.)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
93060|NCT00876460|Secondary|Cmax of Docetaxel in Course 1|Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. PK sampling of docetaxel for this patient was done and included in PK analysis.)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
93061|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. Pharmacokinetic (PK) sampling of docetaxel for this patient was done and included in PK analysis.)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
93062|NCT00876460|Secondary|Cmax of Nintedanib in Course 1|Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1|-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
93063|NCT00876460|Secondary|AUC0-inf of Nintedanib in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1|-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set (AUC0-inf could not be calculated in 5 patients because the elimination phase was not observed in plasma concentration-time profiles in these patients.)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
93064|NCT00876460|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set||Participants|||Number
93065|NCT00876460|Secondary|Time to Treatment Failure (TTF)|"For participants with known date of discontinuation of the study treatment (or progression [not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression] or death): TTF [days] = earlier of date of discontinuation of the study treatment, progression, or death – date the study treatment started + 1.~For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) [days] = date when the patient is known to be progression-free and alive – date the study treatment started + 1.~Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set||Days||95% Confidence Interval|Median
93066|NCT00876460|Secondary|Progression-Free Survival (PFS)|"For participants with known date of progression or death (of any cause): PFS [days] = earlier of date of progression or death – date the study treatment started + 1.~For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) [days] = date of last imaging when the participant is known to be progression-free and alive – date the study treatment started + 1.~Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set||Days||95% Confidence Interval|Median
93067|NCT00876460|Secondary|Disease Control|Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who treated with nintedanib and had both baseline and at least one post-treated tumour measurement by computed tomography (CT) image||Participants|||Number
93068|NCT00876460|Secondary|Objective Tumor Response|Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who were treated with nintedanib and had both baseline and at least one post-treatment tumour measurement by computed tomography (CT) image||Participants|||Number
93069|NCT00876460|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.~The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)."|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set||Participants|||Number
97612|NCT00835172|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
93070|NCT00876460|Primary|Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel|"Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel.~Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) <1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT."|During the first treatment course, up to 3 weeks|Treated set (Patients eligible for DLT confirmation)||Participants|||Number
93071|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
93072|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
93073|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
93074|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
93075|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Milliliters (mL)||Standard Deviation|Mean
93076|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
93077|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
93078|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
93079|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
93080|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Scores on a Scale||Standard Deviation|Mean
93081|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
93082|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
93083|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
93084|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
93085|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received||Incontinence Episodes||Standard Deviation|Mean
93086|NCT00876343|Secondary|Mean Change in Sheehan Disability Scale (SDISS)|"The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period.~The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired)."|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration|||Rating score||Standard Error|Mean
93087|NCT00876343|Secondary|MADRS Response Rate|The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal).|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration|||percentage of subjects|||Number
93088|NCT00876343|Primary|Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group.~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration|||Rating score||Standard Error|Mean
93089|NCT00876265|Primary|Adjusted (LS) Mean Change From Baseline in Wrinkle Severity Rating Scale (SRS) Score of Each Nasolabial Fold (NLF) as Determined by the Blinded Evaluator at Week 12.|The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.|Baseline and Week 12 of follow-up|The Full Analysis Set (FAS) population was the analysis population which was defined as all subjects who were randomized and received at least one injection of the study device to the nasolabial folds.||Wrinkle Severity Rating Score (SRS)||Standard Error|Least Squares Mean
93090|NCT00875979|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival was defined as the time from randomization to first documented disease progression (PD) or death due to any cause within 30 days of the last treatment, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients.||Months||95% Confidence Interval|Median
93091|NCT00875979|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to disease progression (PD) or death from any cause. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease. Only patients with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
93092|NCT00875979|Primary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease.||Percentage of patients||95% Confidence Interval|Number
93093|NCT00875836|Secondary|Marijuana Craving|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course.|8 Weeks|||units on a scale||95% Confidence Interval|Mean
93097|NCT00875810|Primary|Neck Disability Index (NDI) Score|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).~The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.~NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation."|2 years|As this is an observational study not all patients completed NDI questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.||units on a scale||Standard Deviation|Mean
93098|NCT00875810|Secondary|Duration of Pain Prior to Enrollment|Documentation of duration of pain prior to enrollment|Baseline visit|||percentage of patients with pain|||Number
93099|NCT00875810|Primary|EQ-5D|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).~EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by “no problem” in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death."|2 years|As this is an observational study not all patients completed EQ-5D questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.||units on a scale||Standard Deviation|Mean
93100|NCT00875797|Secondary|6-month Survival|Six month follow up|6 month|||participants|||Number
93101|NCT00875797|Secondary|Infection Rate at Participants in Both Groups|Number of infections that occured at participants during study.|participants were followed for the duration of ICU stay (average 3 weeks)|||number of infections|||Number
93102|NCT00875797|Primary|Intestinal Permeability - Lactulose-mannitol(L/M)Test|"Measurement of intestinal permeability using lactulose-mannitol test (L/M test).~Intestinal permeability to sugars is an accurate test for detecting intestinal damage. Intestinal permeability of the epithelium to very small sugar molecules such as lactulose/mannitol may give useful information regarding the overall condition of the digestive tract.~Mannitol is absorbed transcellularly and lactulose has a paracellular route of absorption. Reduction in mannitol absorption shows reduced surface area and increased lactulose absorption indicates a leaky gut.~Lactulose and mannitol are given orally and later determined from the collected urine with HPTLC (high performance thin layer chromatography). The L/M ratio, as a result of lactulose-mannitol tests, is then calculated regarding urine lactulose and mannitol concentrations.~Thus, with the lactulose/mannitol test the intestinal permeability changes due to different reasons can be evaluated."|4 days after admission to intensive care unit|||L/M ratio||Standard Deviation|Mean
93103|NCT00875706|Primary|Number of Participants in Pilot Interviews|This outcome measures the number of participants that participated in interviews that were conducted during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Interview group were analyzed for this outcome. The population included trainees and direct care workers.||participants|||Number
93104|NCT00875706|Primary|Number of Participants in Pilot Surveys|This outcome measures the number of participants that completed the survey during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Survey group were analyzed for this outcome. The population included trainees and direct care workers.||participants|||Number
93105|NCT00875706|Primary|Facility Implementation of Trainings|This measure assesses the number of participating facilities (4) that implemented trainings in their own facilities upon completion of our educational training intervention.|This outcome was assessed at the end of the 1 year pilot study.|This unit of measure for this outcome measure is at the facility level. There were 4 facilities (8 trainees) in total that began the training intervention.||Facility|Participants||Number
93106|NCT00875706|Primary|Completion of Training Intervention|This outcome measures the number of participants that fully completed the training intervention.|This outcome was assessed at the end of the 1 year pilot study.|The analysis population includes only participants who started the Train-the-Trainer intervention and therefore only participants in the Training Feasibility Arm/Group were analyzed for this outcome.||participants|||Number
93107|NCT00875615|Secondary|Number of Patients Achieving Clinical Benefit|Number of patients achieving complete or partial response according to RECIST criteria|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.||participants|||Number
93108|NCT00875615|Primary|Number of Subjects Experiencing Adverse Events|The number of subjects experiencing adverse events after receiving protocol therapy.|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.||participants|||Number
93109|NCT00875589|Primary|Stability of Fixation|The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.|During eye movement recording session (20 sec).|Although there were 15 participants in the Control arm, data were only analyzed for a cohort of 11 that were age-matched to the MTBI arm participants.||degrees||Standard Deviation|Mean
93123|NCT00875485|Secondary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
94169|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
93110|NCT00875563|Primary|Number of Participants With Treatment Success|"Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm.~A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair.~A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis."|6 months|Two patients were lost to follow-up and did not have CT data at 6 months. Patients treated with the Zenith® Fenestrated AAA Endovascular Graft was compared to propensity score matched patients treated with the Zenith® AAA Endovascular Graft (NCT00196092, link to 5-year study results provided).||participants|||Number
93111|NCT00875550|Secondary|Time to Successful Extubation||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Hours||95% Confidence Interval|Median
93112|NCT00875550|Secondary|Time to First Dose of Rescue Medication for Sedation and Analgesia||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Hours||95% Confidence Interval|Median
93113|NCT00875550|Secondary|Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Milligram||Standard Deviation|Mean
93114|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||hours||Full Range|Median
93115|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Hours||Full Range|Median
93116|NCT00875550|Primary|Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.|"Clinical Score Level of Sedation 0 Awake/Alert~Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.~Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.~Deeply sedated: Deep sleep, arousable only with significant physical stimulation.~Unarousable"|6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours||Percentage of subjects|||Number
93117|NCT00875485|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|One month after the administration of the challenge dose (Month 0 to Month 1)|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
93118|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
93119|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
93120|NCT00875485|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
93121|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
93122|NCT00875485|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
93124|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value.|"Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).~Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose."|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
93125|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 15.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||Subjects|||Number
93126|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 14.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||Subjects|||Number
93127|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 13.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||subjects|||Number
93128|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 12.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||subjects|||Number
93129|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 11.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.||subjects|||Number
93130|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.|Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points.||subjects|||Number
93131|NCT00875485|Primary|Anti-HBs Anamnestic Response.|"Anamnestic response was defined as:~Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points.~At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.||Subjects|||Number
93132|NCT00875485|Primary|Anti-HBs Antibody Concentrations|"Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.~Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA."|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.|Analysis was performes on subjects from the Long Term According-to-Protocol (LT ATP) cohort forimmunogenicity on anti-HBs seropositive subjects with available data at the specified time-points.||mIU/mL||95% Confidence Interval|Geometric Mean
93133|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||Subjects|||Number
93152|NCT00875433|Secondary|Disease Control|Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.||Participants|||Number
97613|NCT00835159|Primary|Incidence of POD|Is the incidence of POD not affected by rivastigmine treatment or not.|72 hours postoperatively|||participants|||Number
93134|NCT00875485|Primary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on anti-HAV seropositive subjects with available data at the specified time-points.||mIU/mL||95% Confidence Interval|Geometric Mean
93135|NCT00875433|Secondary|Percentage Peak Trough Fluctuation (PTF)|PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||percentage of peak trough fluctuation||Geometric Coefficient of Variation|Geometric Mean
93136|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,Cmax)|R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||ratio||Geometric Coefficient of Variation|Geometric Mean
93137|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,AUC)|R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||ratio||Geometric Coefficient of Variation|Geometric Mean
93138|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.||hours||Full Range|Median
93139|NCT00875433|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
93140|NCT00875433|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
93141|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.||hours||Full Range|Median
93142|NCT00875433|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
93143|NCT00875433|Secondary|Area Under Curve 0-24 Hours (AUC0-24) on Day 1|AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
93144|NCT00875433|Secondary|Highest CTC Grade for Adverse Events|Highest Common Terminology Criteria (CTC) grade for adverse events|First administration of trial medication until 28 days after last administration of trial medication|All patients from TS with adverse events||Participants|||Number
93145|NCT00875433|Secondary|Average Time-matched Heart Rate Change From Baseline to Day 14.|Average time-matched heart rate change from baseline to day 14.|The day before the first drug dose (baseline) and the day 14.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.||bpm||Standard Error|Mean
93146|NCT00875433|Secondary|Patients With Notable Findings in QT on Day 14|Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT>500 ms.|Day 14|All patients from TS with data for QTcF on day 14||Participants|||Number
93147|NCT00875433|Secondary|Average Time-matched QT Change From Baseline to Day 14|Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.||ms||Standard Error|Mean
93148|NCT00875433|Secondary|Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point|Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model.|Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose )|All patients in TS who had at least 1 time-matched pair of QT measurements available from either Day1 or Day 14 of treatment.||ms||Standard Error|Mean
93149|NCT00875433|Secondary|Patients With Clinically Relevant Findings in ECG on Day 14|Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14.|Day 14|All patients from TS with data for ECG on day 14||Participants|||Number
93150|NCT00875433|Secondary|Patients With Notable Findings in QTcF on Day 14|Notable findings are defined as a QTcF>500 ms or an increase in QTcF of >60ms.|Day 14|All patients from TS with data for QTcF on day 14||Participants|||Number
93151|NCT00875433|Secondary|Duration of Disease Control (DC)|Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.||weeks||95% Confidence Interval|Median
97650|NCT00835003|Secondary|Neonatal Diagnoses||30 days||||||
97651|NCT00835003|Primary|Neonatal Admission After Elective Caesarean Section||48 hours|||participants|||Number
93154|NCT00875433|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from TS who progressed or died.||weeks||95% Confidence Interval|Median
93155|NCT00875433|Primary|Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14|Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.||ms||Standard Error|Mean
93156|NCT00875433|Primary|Objective Response (OR)|OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.||Participants with OR|||Number
93157|NCT00875420|Primary|Percent Change in Composite Score Over Time|Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.||Percent change from baseline||Standard Deviation|Mean
93158|NCT00875420|Secondary|Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.|Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.||Percent change from baseline||Standard Deviation|Mean
93159|NCT00875420|Secondary|Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.|Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.||Percent change from baseline||Standard Deviation|Mean
93160|NCT00875420|Primary|Percent Change in Frequency of Hot Flashes Over Time|Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.||Percent change from baseline||Standard Deviation|Mean
93161|NCT00875394|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 weeks|Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.|||||
93162|NCT00875329|Primary|Responses From the TBI Clinical Reminder|The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview.|April 2007 January 2012|||percentage of participants|||Number
93163|NCT00875212|Primary|Minimum pH After 14 Days of Use of Dentifrice|measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).|14 days|The initial part of the work as a pilot study.||pH||Standard Deviation|Mean
93164|NCT00875212|Primary|Minimum pH|The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose.|at 1 minute (minimum fermenting pH) or at 7 minutes|The number of subjects were determined by a pilot study carried out in 3 volunteers. The study has a crossover design. Thus the 4 groups of dentifrices tested included the same subjects in a different time-measurement avoiding the influence of individual variables in the analysis.||pH||Standard Deviation|Mean
93165|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
93166|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
93183|NCT00874770|Secondary|Percentage of Participants With Early Virologic Response (EVR) at Week 12|EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.|At Week 12|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
93167|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
93168|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.|||||
93169|NCT00874887|Secondary|Minimum Inhibitory Concentration (MIC) Range at Day 14|MIC range at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2. The MIC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
93170|NCT00874887|Secondary|Minimum Inhibitory Concentration 90 (MIC90) at Day 14|The Minimum Inhibitory Concentration 90 (MIC90) is the minimum concentration required to inhibit the growth of 90% of microorganisms. The MIC90 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
93171|NCT00874887|Secondary|Minimum Inhibitory Concentration 50 (MIC50) at Day 14|The Minimum Inhibitory Concentration 50 (MIC50) is the minimum concentration required to inhibit the growth of 50% of microorganisms. The MIC50 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
93172|NCT00874887|Secondary|Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14|Mutant Prevention Concentration (MPC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MPC is the lowest drug concentration which prevents growth of any colony of bacteria on the conjunctiva. The MPC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.||micrograms per milliliter (ug/mL)|||Number
93173|NCT00874887|Primary|Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14|Percentage of subjects with strain resistance as determined by Minimum Inhibitory Concentration (MIC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. One patient in the Zymar® group did not have cultures performed at Day 14.||Percentage of Subjects|||Number
93174|NCT00874848|Secondary|Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review|"Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator.~If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date."|From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||months||95% Confidence Interval|Median
93184|NCT00874770|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.|At Week 4|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
93185|NCT00874770|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12|eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.|A Weeks 4 and 12|All participants who received at least 1 dose of study drug.||percentage of participants|||Number
93200|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2||Day 28 Post-vaccination 2|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
93175|NCT00874848|Secondary|Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review|"The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||months||95% Confidence Interval|Median
93176|NCT00874848|Secondary|Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review|"The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||participants|||Number
93177|NCT00874848|Secondary|Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review|"The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||participants|||Number
93178|NCT00874848|Secondary|Overall Survival (OS) in Each Study Arm Based on the Safety Population|Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.|From the time of randomization to death, subject being lost to follow-up or study completion|The safety population comprised all randomized subjects who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin.||months||95% Confidence Interval|Median
93179|NCT00874848|Primary|Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review|"Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a ‘confirmation’ response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.||participants|||Number
93180|NCT00874822|Primary|Obstructive Sleep Apnea|The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.|9 Months|||participants|||Number
93181|NCT00874770|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.|From screening up to Week 12 (treatment period)|All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point||participants|||Number
93186|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From Day 31 up to Week 24 of post treatment follow-up|All participants who received at least 1 dose of study drug. n=evaluable patients||participants|||Number
93187|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug|All participants who received at least 1 dose of study drug.||participants|||Number
93188|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days post-vaccination|Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
93189|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
93190|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.||Titers||95% Confidence Interval|Geometric Mean
93191|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
93192|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
93193|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days Post-vaccination 2|Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.||Titers||95% Confidence Interval|Geometric Mean
93194|NCT00874549|Primary|Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2|Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|Day 0 to 7 Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.||Participants|||Number
93195|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2|Solicited injection site reactions: Pain, Erythema, and Swelling.|0-7 Days Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.||Participants|||Number
93196|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.||Titers||95% Confidence Interval|Geometric Mean
93197|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2||28 Days post-vaccination 2|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.||Percentage of Participants|||Number
93198|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
93199|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.||Titers||95% Confidence Interval|Geometric Mean
93201|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.||Percentage of Participants|||Number
93202|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.|Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|0-7 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.||Participants|||Number
93203|NCT00874510|Primary|Hours Slept on Overnight Extended Duty Call Shifts|Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.|12 months|||hours|Participants|95% Confidence Interval|Mean
93204|NCT00874276|Secondary|Terminal Half-life (the Amount of Time Needed to Clear One-half of the Dose of Drug)for Environmental Dose 2.5 ug/kg/Day.|Terminal half-life (the amount of time needed to clear one-half of the dose of drug)for the environmental dose 2.5 ug/kg/day.|24 hours for analysis on Day 5, Environmental dose|same as Primary||minutes||Inter-Quartile Range|Median
93205|NCT00874276|Primary|Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized.|Terminal half-life (the amount of time needed to clear one-half of dose of the drug).|24 hours for analysis on Day 5, Clinical dose|All completing subjects (2 withdrawals have no pharmacokinetic data on this parameter) The intent was to accrue 12 per group but the grant ended before that could be achieved. Subjects were recruited from a large pool but the two genetically defined subgroups are rare.||Minutes||Inter-Quartile Range|Median
93206|NCT00874250|Secondary|Time in Days to Return to Normal Daily Activities|This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.|Average time of one month|||Days||Full Range|Median
93207|NCT00874250|Secondary|Total Length of Hospital Stay (Days)|Total days of hospital stay during the initial hospitalization for implantation of device|Total Duration of the Index Hospitalization|||Days||Full Range|Median
93208|NCT00874250|Secondary|Days of Convalescence Stay in an Intensive Care Unit|Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation|During the Index Hospitalization|||participants|||Number
93209|NCT00874250|Secondary|Operative Blood Loss (mL)|Blood loss in mL during initial device implantation procedure|Initial Device Implant Procedure During Index Hospitalization|||mL||Standard Deviation|Median
93210|NCT00874250|Secondary|Procedure Time (Minutes)|Total time in minutes required for surgical device implantation.|Initial Device Implant Procedure During Index Hospitalization|||Minutes||95% Confidence Interval|Median
93211|NCT00874250|Secondary|The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.||Treatment through 1 month post procedure|||participants|||Number
93212|NCT00874250|Primary|The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment||Treatment through 1 month post treatment|||participants|||Number
93213|NCT00874120|Primary|Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).|Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.|24 hours after final dose of each 7-day treatment period.|The per-protocol population included 100 participants who completed both treatment periods and have 24-hour Ambulatory Blood Pressure Monitoring (ABPM) data for SBP measurements for each study drug, 46 participants who received phenylephrine followed by placebo and 54 participants who received placebo followed by phenylephrine.||mmHg||Standard Deviation|Mean
93214|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks|Pre-treatment to 6 weeks after treatment|||units on a scale||Standard Deviation|Mean
93215|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks|Pre-treatment to 2 weeks after treatment|||units on a scale||Standard Deviation|Mean
93216|NCT00874094|Secondary|Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week|pre-treatment to 1 week after treatment|The number of participants required to demonstrate a 1 point difference between pre and post treatment values||units on a scale||Standard Deviation|Mean
93217|NCT00874094|Primary|Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.|Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.|Difference in Measurements taken Pre-treatment and 12 weeks after treatment.|Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant.||units on a scale||Standard Deviation|Mean
93218|NCT00874029|Secondary|Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)|The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.|12 months|||percentage of patients|||Number
93219|NCT00874029|Secondary|Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)|The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.|12 months|||Units on a scale||Standard Deviation|Mean
93245|NCT00873730|Secondary|Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.|Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 – 10 (0 = no pain and 10 = most severe pain).|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
93220|NCT00874029|Secondary|Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.|"The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life.~Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates change in symptoms, a negative number indicates a reduction in symptoms and therefore improvement.~Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates change in health and quality of life, a positive number indicates and improvement."|12 months from Baseline|||Units on a scale||Standard Deviation|Mean
93221|NCT00874029|Secondary|Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)|Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.|12 month from Baseline|The Full Analysis Set (FAS) was used in the analysis of the change in total uterine and fibroid volumes between baseline and 12 months post treatment. Of the 137 Subjects enrolled, two were excluded from the FAS because they did not meet all of the inclusion/exclusion criteria.||percentage of volume||95% Confidence Interval|Mean
93222|NCT00874029|Primary|Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment|Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.|12 months from Baseline|||participants|||Number
93223|NCT00874029|Primary|Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure|An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).|12 months|||participants|||Number
93224|NCT00874029|Primary|Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure|Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.|12 months from Baseline|||Percentage of participants|||Number
93225|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-181 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
93226|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-29 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
93227|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One AE||Days 1-15 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
93228|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)|Solicited symptoms were collected from administration of investigational product through Study Day 15. For this study, solicited symptoms included: fever (> 100°F oral), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), headache.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
93243|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0–10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
93229|NCT00873912|Primary|Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.||participants|||Number
93230|NCT00873873|Secondary|Protease/Antiprotease|"MMP9/TIMP 1 molar ratio MMP9 is matrix metalloproteinse 9 and is a protease enzyme that is responsible for tissue degradation of extracellular matrix and could be a factor in airway remodeling.~TIMP 1 is an abbreviation for tissue inhibitor of metalloproteinase-1 and is an inhibitor of MMP9 and would serve to balance the activity protease activity of MMP9 and this it is an anti-protease.~Therefore the ratio of MMP9 and TIMP1 is used to assess the relative balance of protease and antiprotease activity."|Measured at Year 2|54 participants had induced sputum data but 1 was excluded due to congenital anatomical anomaly (bronchial atresia).||ratio||Standard Deviation|Mean
93231|NCT00873873|Primary|Airway Wall Thickness|Segmental average airway wall thickness|Measured at Year 2|There were 43 participants with Chest CT data; 1 was excluded from the analysis due to incidental finding of an anatomical congenital anomaly.||mm||Standard Deviation|Mean
93232|NCT00873821|Primary|Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration|Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24|Baseline (predose Day 1) to Day 13|||mg/dL||Standard Deviation|Least Squares Mean
93233|NCT00873821|Primary|Number of Participants With Any Laboratory Adverse Experience|Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.|2 months|All study participants||participants|||Number
93234|NCT00873821|Primary|Number of Participants With Any Clinical Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.|2 months|All study participants||participants|||Number
93235|NCT00873782|Primary|Muscle, Nerve, or Vascular Damage|"Number of Participants with all of the following three:~Unchanged Doppler ultrasound to assess venous and arterial damage pre-and post perfusion based on report~Without clinically significant changes in electrodiagnostic testing using standard neurographic techniques pre-and post perfusion:>1 mSec change in baseline distal motor latency; <75% baseline compound muscle action potential amplitude, <75% baseline conduction velocity, sensory nerve action potential~Without clinically significant changes in Quantitative muscle testing (QMT) strength assessments pre-and post perfusion:< 85% baseline"|Measured within 2 weeks after limb perfusion procedure|||participants|||Number
93236|NCT00873730|Secondary|Change in C-reactive Protein (CRP) From Baseline to Week 12.|CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.|Baseline and 12 weeks|The analysis population is the intent to treat.||mg/l||Standard Deviation|Mean
93237|NCT00873730|Secondary|Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms||12 weeks|The population for this assessment was patients who had ocular inflammatory disease at baseline. The number of patients analyzed is zero because no patients had symptoms of ocular inflammatory disease at baseline.||patients|||Number
93238|NCT00873730|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and 12 weeks|The analysis population was the intent to treat population. Two scored areas had a different “Number of Participants Analyzed” in the etanercept arm. Bodily pain had 45 and Emotional role limitations had 46.||units on scale||Standard Deviation|Mean
93239|NCT00873730|Secondary|Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire|EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
93240|NCT00873730|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation.|Baseline and 12 weeks|The analysis population was the intent to treat population.||mm/hour||Standard Deviation|Mean
93241|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober’s test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
93242|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
93244|NCT00873730|Secondary|Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.|Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 – 10 (0 = none and 10 = severe).|Baseline and 12 weeks|The analysis population was the intent to treat population.||units on scale||Standard Deviation|Mean
93246|NCT00873730|Secondary|Number of Patients Achieving Partial Remission.|Partial remission defined as a score of less than 20 units (on a scale of 0–100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
93247|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
93248|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
93249|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
93250|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
93251|NCT00873730|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.||patients|||Number
93252|NCT00873457|Secondary|Event-free Survival|Event-free survival will be defined as the length of time between the discontinuation of study treatment and disease progression, next therapy, or death,whichever comes first, up to a maximum of 2 years.|up to a maximum of 2 years|All treated patients||Days||Full Range|Median
93253|NCT00873457|Secondary|Overall Survival|Overall survival is defined as the length of time between discontinuation of perifosine until death or 2 year's followup, whichever comes first.|up to a maximum of 2 years|All treated patients||Days||Full Range|Median
93254|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 6 months of treatment|Patients who completed 6 months of therapy||participants|||Number
93255|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 3 months of treatment|Patients who completed 3 months of therapy.||participants|||Number
93256|NCT00873327|Primary|Piperacillin Pharmacokinetics (PK)|To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study|2-3 days after infant receives 1st drug dosing|All 32 subjects that were enrolled during the study.||L/hr/kg||95% Confidence Interval|Median
93257|NCT00873119|Secondary|Time to Progression (TTP)|Time from the date of randomization to the time of disease progression|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported.||months||95% Confidence Interval|Median
93258|NCT00873119|Secondary|Duration of Response|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD ([Progressive Disease]) or death was documented|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication||months||95% Confidence Interval|Median
93259|NCT00873119|Secondary|Time to Response|For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Patients with overall best response being either complete response or partial response.||months||Full Range|Median
93260|NCT00873119|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored.||months||95% Confidence Interval|Median
93261|NCT00873119|Secondary|Best Overall Response|The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR)|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population.||percentage of participants|||Number
93262|NCT00873119|Primary|Progression Free Survival|Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy||months||95% Confidence Interval|Median
93263|NCT00873093|Other Pre-specified|Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.|This outcome measure cannot be reported due to the data used for analysis was not collected.|Day 8 of blocks 1 and 2||||||
93264|NCT00873093|Other Pre-specified|Plasma Concentration-time Profiles|Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).|Up to day 8 of block 2|These were for correlative biology studies and the data were not collected in COG database.|||||
93265|NCT00873093|Other Pre-specified|Change in Stem Cell Percentage|Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.|Baseline to post-treatment with bortezomib|These were for correlative biology studies and the data were not collected in COG database.|||||
93266|NCT00873093|Other Pre-specified|Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots|Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.|||||
93267|NCT00873093|Other Pre-specified|NF-kB Activity|NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.|||||
93268|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3.|End of Block 3 (Day 36 of Block 3) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3.||Percentage of participants|||Number
93269|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2.|End of Block 2 (Day 36 of Block 2) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.||percentage of participants|||Number
93270|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1.|End of Block 1 (Day 36 of Block 1) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.||percentage of participants|||Number
93271|NCT00873093|Primary|Severe Adverse Events (SAE) Rate.|The proportion of SAE rate among all eligible patients|4 months|The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.||percentage of participants|||Number
93272|NCT00873093|Primary|Toxic Death Rate|The proportion of toxic death rate among all eligible patients.|4 months|The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.||percentage of participants|||Number
93273|NCT00873093|Primary|Event Free Survival|Percentage of patients who were event free at 4 months|4 months after enrollment|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.||Percentage of participants|||Number
93274|NCT00873093|Primary|Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy|The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.|The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.||Percentage of participants|||Number
93275|NCT00873041|Secondary|Extension Study: Change From Baseline in Transferrin Saturation at Month 24|Blood was collected for transferrin saturation at Baseline and Month 24. Change from baseline= Month 24 transferrin saturation - baseline transferrin saturation.|Core Baseline, Month 24|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.||Percent saturation||95% Confidence Interval|Mean
93276|NCT00873041|Secondary|Extension Study: Change From Baseline in Hemoglobin at Month 24|Blood was collected for Hemoglobin at Baseline and Month 24. Change from Baseline= Month 24 hemoglobin - Baseline hemoglobin.|Core Baseline, Month 24|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.||g/L||95% Confidence Interval|Mean
93277|NCT00873041|Secondary|Extension Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for serum ferritin difference from Baseline at Month 24 versus LIC difference from Baseline at Month 24.~A value of 1.0 indicates a perfect correlation."|Core Baseline, Month 24|Participants from the Extension Full Analysis Set (all randomized participants)in the Extension Study with data available for analysis.||Correlation coefficient|||Number
93278|NCT00873041|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|LIC was measured by magnetic resonance imaging technique at Baseline and Month 24. A negative change from baseline indicated improvement.|Core Baseline, Month 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
93279|NCT00873041|Primary|Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study|Liver iron concentration was measured at Core Baseline and at the end of the Extension Study. Magnetic Resonance Imaging (MRI) scans were analyzed at a central laboratory to determine the LIC value. The percentage of participants with LIC < 5 mgFe/g dw (milligram iron/gram dry weight) change from Baseline at the end of the Extension Study is reported.|Core Baseline to End of Extension Study (up to 24 months)|Full Analysis consisted of all randomized participants. Patients with post-baseline LIC satisfying criterion at any time during the study are counted as responder. Patients with no baseline LIC or without any post-baseline LIC measurements will be assumed as non-responder.||Percentage of participants||95% Confidence Interval|Number
93280|NCT00873041|Secondary|Extension Study: Absolute Change in Serum Ferritin From Baseline to Eighth Quarter|Blood was collected for serum ferritin at Core Baseline and monthly during the Eighth quarter of the Extension Study. Absolute change from Baseline: quarterly average – baseline average. A negative change from baseline indicated improvement.|Core Baseline, Eighth Quarter (last 3 months of the study)|Full Analysis Set included all randomized participants. Only patients with a value both at baseline and at considered time point are included.||micrograms/liter||Standard Deviation|Mean
93281|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Pulse Rate|"Pulse Rate was measured at each visit.~A Notably Abnormal Pulse Rate was defined as a measurement in one of the following two categories:~High: ≥120 with an increase from baseline ≥15 beats per minute (bpm)~Low: ≤50 with a decrease from baseline ≥15 bpm"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.||Percentage of participants|||Number
93282|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Diastolic Blood Pressure|"Diastolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.~A Notably Abnormal Diastolic Blood Pressure was defined as a measurement in one of the following two categories:~High: ≥105 with an increase from baseline ≥15 mmHg~Low: ≤50 with a decrease from baseline ≥15 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.||Percentage of participants|||Number
93283|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Systolic Blood Pressure|"Systolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.~A Notably Abnormal Systolic Blood Pressure was defined as a measurement in one of the following two categories:~High: ≥180 with an increase from baseline ≥20 mmHg~Low: ≤90 with a decrease from baseline ≥20 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.||Percentage of participants|||Number
93284|NCT00873041|Primary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 52 with treatment as factor and baseline LIC as covariate.|Baseline, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
93285|NCT00873041|Secondary|Core Study: Percentage of Participants With Notable Abnormal Post-baseline Laboratory Results|"The percentage of participants with notable laboratory results:~Platelet count: (<100 x 10^9/L)~Absolute neutrophils: (<1.5 x 10^9/L)~Alanine aminotransferase (ALT): (>5 x Upper limit normal (ULN) and >2 x baseline).~Aspartate aminotransferase (AST): (>5 x ULN and >2 x baseline)~Serum creatinine: (>33% increase from baseline and >ULN at ≥2 consecutive post-baseline values) Creatinine clearance: (<60 mL/min at ≥2 consecutive post-baseline values)~Urinary protein/creatinine ratio: (≥ 1.0 mg/mg at ≥2 consecutive post-baseline values)"|52 Weeks|Safety Set included all randomized participants who received treatment.||Percentage of participants|||Number
93409|NCT00871715|Secondary|Upper Extremity Fugl Meyer (UEFM), Motor Component|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93286|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) in Placebo Patients From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. The change in liver iron concentration for participants in the placebo arm was used to assess the iron accumulation rate.|Baseline, Week 52|Safety Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
93287|NCT00873041|Secondary|Core Study: Change From Baseline in Transferrin Saturation at Month 12|Blood was collected for transferrin saturation at Baseline and Month 12. Change from baseline= Month 12 transferrin saturation - baseline transferrin saturation.|Baseline, Month 12|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.||Percent saturation||Standard Deviation|Mean
93288|NCT00873041|Secondary|Core Study: Change From Baseline in Hemoglobin at Month 12|Blood was collected for Hemoglobin at baseline and Month 12. Change from baseline= Month 12 hemoglobin - baseline hemoglobin.|Baseline, Month 12|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.||g/L||Standard Deviation|Mean
93289|NCT00873041|Secondary|Core Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for the following cases:~Baseline serum ferritin versus baseline LIC~Serum ferritin difference from baseline at fourth quarter versus difference from baseline in LIC at Week 52.~A value of 1.0 indicates a perfect correlation."|Baseline, 52 weeks|Participants from the Full Analysis Set (all randomized participants).||Correlation coefficient|||Number
93290|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline At Week 24 and Week 52 in Patients With Dose Increases After Week 24|LIC was measured by magnetic resonance imaging technique at baseline, Week 24 and Week 52. Dose Doubling (Dose Increases) began at Week 24.|Baseline, Week 24, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24 and Week 52. Only patients with dose increases after week 24, with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
93291|NCT00873041|Secondary|Core Study: Percentage of Participants With Adverse Events Graded Mild, Moderate and Severe|Percentage of Participants with Mild, Moderate and Severe adverse events (AE) any primary system organ class regardless of study drug relationship. A patient with multiple occurrences of an AE is counted only once in the AE category for that treatment. A patient with multiple severity ratings for an AE while on a treatment is only counted once under the maximum rating.|52 Weeks|Safety Analysis Set included all randomized participants who received treatment.||Percentage of participants|||Number
93292|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Second Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.~Second quarter serum ferritin average was the average of all serum ferritin values obtained within days 106-195.~Change from baseline: second quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 106 to Day 195)|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the second quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.||μg/L||Standard Deviation|Mean
93293|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Fourth Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.~Fourth quarter serum ferritin average was the average of all serum ferritin values obtained within days 286- End of Study.~Change from baseline: fourth quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 286 to End of Study [Day 365])|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the fourth quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.||μg/L||Standard Deviation|Mean
93294|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 24|LIC was measured by magnetic resonance imaging technique at baseline and Week 24. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 24 with treatment as factor and baseline LIC as covariate.|Baseline, Week 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24. Only patients with both baseline and at least one post-baseline value were included for this analysis.||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
93295|NCT00873015|Secondary|Efficacy of 14 Day Infusion of Sodium Nitrite||14 days||||||
93296|NCT00873015|Secondary|Safety of a 14 Day Infusion of Sodium Nitrite||14 days||||||
93297|NCT00873015|Primary|Mean Plasma Nitrite Concentration (Micromol/L)|Samples for pharmacokinetic analysis were collected from subjects treated with sodium nitrite at -15, -5, 0, 10, 30, 60, and 90 minutes after starting nitrite infusion and then at 2, 4, 6, 8, 12, 24, and every 24 hours after starting nitrite infusion. The sample at the time of starting the infusion was considered to be the time 0 sample. On study day 14 additional blood samples were collected at 0, 10, 30, 60, and 90 minutes and at 2, 4, 6, 8, and 12 hours after stopping nitrite infusion. Blood samples were analyzed for nitrite levels using mass spectroscopy.|multiple time points up to the end of day 14|Per protocol||micromol/L||Standard Deviation|Mean
93298|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.||participants|||Number
93299|NCT00872989|Secondary|Time to Treatment Failure|Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|||Months||95% Confidence Interval|Median
93300|NCT00872989|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
93301|NCT00872989|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|every 3 months for two years and then every 6 months for 3 years|||months||95% Confidence Interval|Median
93302|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.||participants|||Number
93303|NCT00872989|Primary|Progression Free Survival (PFS)|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years|||months||95% Confidence Interval|Median
93304|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale|"The Children’s Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93305|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale|"The Children’s Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93306|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale|"The Children’s Communication Checklist-2 (CCC-2) Nonverbal Communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93307|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale|"The Children’s Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93308|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale|"The Children’s Communication Checklist-2 (CCC-2) Scripted Language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93309|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale|"The Children’s Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93310|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale|"The Children’s Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93311|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale|"The Children’s Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93312|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale|"The Children’s Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93313|NCT00872898|Secondary|Change in Children’s Communication Checklist-2 (CCC-2) - Speech Subscale|"The Children’s Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93314|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Communication|"The Core Autism Treatment Scale-Improvement (CATS-I) Communication Subscale is based on rating 5 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 5 (improved) to 35 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93315|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Social Interaction|"The Core Autism Treatment Scale-Improvement (CATS-I) Social Interaction Subscale is based on rating 9 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 9 (improved) to 63 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93329|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Bcl-2)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
93316|NCT00872898|Primary|Change in Total Raw Score of Social Responsiveness Scale|"The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment).~Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93317|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Total Score|"The Core Autism Treatment Scale-Improvement (CATS-I) is based on rating 14 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 14 (improved) to 98 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.||units on a scale||Standard Error|Least Squares Mean
93318|NCT00872898|Primary|Extent of Absorption of Memantine (Part One)|Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.|Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose|Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population)||ng•h/mL||Standard Deviation|Mean
93319|NCT00872833|Secondary|Report of Pain by Length of the Transfusion Cycle|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles|Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group.||percentage of participant-cycles|Participants||Number
93320|NCT00872833|Primary|Report of Pain by Age Group|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles|||percentage of participant-cycles|Participants||Number
93321|NCT00872729|Primary|Pharmacodynamic Parameter: Changes of White Blood Cell (WBC) Cystine Level From Baseline|"The pharmacodynamic (PD) parameter measures the changes of WBC cystine level from the baseline.~Cystine is a disulfide amino acid formed through oxidation of two molecules of cysteine; hence, cystine’s concentration is commonly given in half-cystine equivalents to avoid confusion.~The level of cystine in WBC/leukocytes is expressed in units of nmol half-cystine/mg protein (nmol ½ cystine/mg protein). Half-cystine is quantified by a reduction of cystine followed by an assay for cysteine, which is then normalized by the total cellular protein content within the sample using methods of such as Lowry assay, bicinchoninic acid assay, or Bradford."|up to 12 hours post Cystagon® dosing and RP103 dosing|Sample size is based on feasibility rather than statistical considerations. Analysis time differences (0-6 hours) is due to different absorption characteristics of Cysteamine between RP103 and Cystagon. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.||nmol 1/2 cystine/mg protein||Standard Deviation|Mean
93322|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: AUC(0-t) of Cysteamine|t = 6 for Cystagon and t = 12 for RP103. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.|12 hours post RP103 dosing and 6 hours post 1st Cystagon® dosing|Subjects were enrolled sequentially according to the study design. A mixed-effects linear model was used to assess differences between the RP103 and Cystagon treatment groups. Sample size is based on feasibility rather than statistical considerations.||umol•h/L||Geometric Coefficient of Variation|Geometric Mean
93323|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Tmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing|||hour||Full Range|Median
93324|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Cmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing|||umol/L||Geometric Coefficient of Variation|Geometric Mean
93325|NCT00872599|Secondary|HDL-cholesterol Measured During High Salt Fenofibrate in Salt-resistant and Salt-sensitive Hypertension|HDL-cholesterol concentration measured on the last day of fenofibrate treatment in salt-resistant and salt-sensitive hypertensive patients|Measured on day 6 of high salt intake and fenofibrate treatment|All subjects who completed the protocol||mg/dL||Standard Deviation|Mean
93326|NCT00872599|Primary|Change in Blood Pressure During High Salt Intake and Fenofibrate Treatment Compared to High Salt Intake and Placebo Treatment|"Difference in blood pressure (mean arterial pressure) measured on the last day of high salt intake and fenofibrate treatment minus blood pressure (mean arterial pressure) measured during high salt intake and placebo treatment in participants classified as being salt-sensitive versus salt-resistant.~Participants were classified as salt-sensitive if the average study day mean arterial pressure (MAP) was at least 5 mmHg higher during the high salt placebo arm than during low salt intake."|pressure measured on day 6 of high salt fenofibrate minus pressure measured on day 6 of high salt placebo|All subjects who completed entire protocol||mm Hg||Standard Deviation|Mean
93327|NCT00872534|Primary|Incidence of Subjects With Gastroduodenal Erosions and Ulcers.|Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).|After 7 days of study medication|||participants|||Number
93328|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (FGFR3)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
93330|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
93331|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (p53).|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.||Percentage of participants|||Number
93332|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
93333|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
93334|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
93335|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (p53)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.||Participants|||Number
93336|NCT00872521|Secondary|Assessment of Quality of Life (AQoL) Scores|The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).|Up to 2 years|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Scores on a scale||Standard Deviation|Mean
93337|NCT00872521|Secondary|Overall Survival|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Percentage of participants|||Number
93338|NCT00872521|Secondary|Event Free Survival (EFS)|Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Percentage of participants|||Number
93339|NCT00872521|Secondary|Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.|3-months after ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Participants|||Number
93340|NCT00872521|Secondary|Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).|Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.|3-months following ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Participants|||Number
93341|NCT00872521|Secondary|Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD||Particiipants|||Number
93342|NCT00872521|Primary|Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|International Myeloma Working Group (IMWG) criteria – CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour|84 days|Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.||Participants|||Number
93343|NCT00872430|Primary|Intestinal Transit Time|Radiologic technique consisting of the ingestion of radiopaque markers, followed by a simple x-ray of the abdomen on day 3 of each intervention period. Standard formula, regarding markers ingested, time of ingestion and markers still present on the colon (counted by radiologist unaware of the treatment allocation), provided transit time.|day 3 and day 17|||hours||Standard Deviation|Mean
93344|NCT00872430|Secondary|Number of Patients With no Evacuation After Each Intervention Period|The number of patients who had not evacuated on day 5 of each intervention period was obtained using questions 1 and 9 of the Scale for Assessment of Constipation Symptoms based on: 1) How many times have you had a bowel movement in the last 24 hours?; 9) Classification of bowel habit on a scale of 1 (terrible) to 5 (excellent).|day 5 and day 19|||participants|||Number
93345|NCT00872339|Secondary|Impact of Pain on Functioning and Well-being||Measured at Month 9|||participants|||Number
93346|NCT00872339|Secondary|Pain Occurrence by Age||Measured at Month 9|||participants|||Number
93347|NCT00872339|Secondary|Common Sites of Pain||Measured at Month 9|||participants|||Number
93348|NCT00872339|Primary|Prevalence of Pain||Measured at Month 9|||participants|||Number
93349|NCT00872170|Secondary|Change in Arginase Activity From Baseline to Week 12 Among Sildenafil Group|Change in Arginase activity was calculated as Arginase activity at week 12 minus Arginase activity at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||U/L||Standard Error|Mean
93350|NCT00872170|Secondary|Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group|Change in Arginase concentration was calculated as Arginase concentration at week 12 minus Arginase concentration at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ng/ml||Standard Error|Mean
93351|NCT00872170|Secondary|Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group|Change in Cell Free Hemoglobin was calculated as Cell Free Hemoglobin at week 12 minus Cell Free Hemoglobin at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ug/ml||Standard Error|Mean
93352|NCT00872170|Secondary|Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group|Change in Lactate dehydrogenase (LDH) was calculated as LDH at week 12 minus LDH at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no LDH at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.||U/L||Standard Error|Mean
93353|NCT00872170|Secondary|Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group|Change in Soluble platelet selectin (sP-SELECTIN) was calculated as sP-SELECTIN at week 12 minus sP-SELECTIN at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ng/ml||Standard Error|Mean
93354|NCT00872170|Secondary|Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Red Blood Cell (RBC) Arginine was calculated as Red Blood Cell (RBC) Arginine at week 12 minus Red Blood Cell (RBC) Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||µM||Standard Error|Mean
93355|NCT00872170|Secondary|Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Plasma Arginine was calculated as Plasma Arginine at week 12 minus Plasma Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||µM||Standard Error|Mean
93356|NCT00872170|Secondary|Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end diastolic volume (LVEDV) was calculated as LVEDV at week 12 minus LVEDV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ml||Standard Error|Mean
93357|NCT00872170|Secondary|Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end systolic volume (LVESV) was calculated as LVESV at week 12 minus LVESV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||ml||Standard Error|Mean
93358|NCT00872170|Secondary|Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group|Change in tricuspid regurgitant jet velocity (TRV) was calculated as TRV at week 12 minus TRV at baseline. The TRV provides an estimate of pulmonary artery pressure.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.||m/s||Standard Error|Mean
93405|NCT00871715|Secondary|Satisfaction With Life Scale (SWLS)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93359|NCT00872170|Primary|Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group|Change in six-minute walk test (6MWT) distance was calculated as 6MWT at week 12 minus 6MWT at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no 6MWT at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.||meters||Standard Error|Mean
93360|NCT00872079|Primary|Patient Genomics|During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.|Baseline|||participants|||Number
93361|NCT00872001|Secondary|Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population)|Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.||Percentage of Participants|||Number
93362|NCT00872001|Primary|Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)|Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.||Percentage of Participants|||Number
93363|NCT00871975|Primary|Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics|The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.|1 Year|Male and female patients were included, where the urodynamics tracings were compared against the Tetra NIRS tracings.||participants|||Number
93364|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
93365|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
93366|NCT00871871|Primary|Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.|90 -120 minutes post-dose|Number of participants who took ISMN/placebo.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
93367|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)|Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.||ng/minute||Standard Deviation|Least Squares Mean
93406|NCT00871715|Secondary|Motor Activity Log 28 QOM (MAL-28)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93368|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
93369|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.||ng/minute||Standard Deviation|Least Squares Mean
93370|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)|Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.||ng/minute||Standard Deviation|Least Squares Mean
93371|NCT00871819|Primary|Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)||Immediately post-procedure|||Correlation coefficient|||Number
93372|NCT00871780|Secondary|Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48|To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 – speed at baseline)/speed at baseline*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n= number of participants with evaluable data at time point.||participants|||Number
93373|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93374|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93375|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93376|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93377|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93378|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93379|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93407|NCT00871715|Secondary|As-Tex Sensory Index|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93380|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.||Correlation coefficient|||Number
93381|NCT00871780|Primary|Change From Baseline in Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.||units on a scale||Inter-Quartile Range|Median
93382|NCT00871780|Primary|Change From Baseline in Maximum Walking Distance (MWD)||Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=those participants with observed data at given time point.||meters||Inter-Quartile Range|Median
93383|NCT00871780|Primary|Change From Baseline in the Timed 25-foot Walk Test (T25FW)|In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.||seconds||Inter-Quartile Range|Median
93384|NCT00871780|Primary|Change From Baseline in the Timed 100-meter Walk Test (T100T)|In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.||seconds||Inter-Quartile Range|Median
93385|NCT00871728|Secondary|Percentage of Participants Showing Mycological Cure|Mycological cure was defined as a case in which the results of both potassium hydroxide (KOH) smear test and bacterial identification test (BIT) were found to be negative at each pre-defined time point.|Week 13, 25, 37 and 49|The FAS population, missing values imputed using last observation carried forward (LOCF) method. 'n' included those participants who were evaluable for this measure at specific time points.||percentage of participants|||Number
93386|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 49 compared to Baseline were reported.|Baseline and Week 49|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
93387|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 37 compared to Baseline were reported.|Baseline and Week 37|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
93388|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 25 compared to Baseline were reported.|Baseline and Week 25|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
93389|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 13 compared to Baseline were reported.|Baseline and Week 13|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
93408|NCT00871715|Secondary|Patient Health Questionnaire 9 (PHQ-9)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93972|NCT00866034|Primary|Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle.||2 years|||Cumulative live birth rate (%)|||Number
93390|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 9 compared to Baseline were reported.|Baseline and Week 9|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
93391|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 5 compared to Baseline were reported.|Baseline and Week 5|The Full analysis set (FAS) population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.||percentage of participants|||Number
93392|NCT00871715|Other Pre-specified|Exit Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Post-intervention to 1 year post-randomization||08/2016||||
93393|NCT00871715|Other Pre-specified|Post-Intervention Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|16-20 weeks post-randomization||08/2016||||
93394|NCT00871715|Other Pre-specified|Monthly Telephone Interviews|A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|monthly, beginning 30 days post-randomization||08/2016||||
93395|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)|Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93396|NCT00871715|Secondary|Color Trails Making Tests 1 & 2|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93397|NCT00871715|Secondary|Digits Span Backward|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93398|NCT00871715|Secondary|Hopkins Verbal Learning Test, Revised (HVLT-R)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93399|NCT00871715|Secondary|D-KEFS Verbal Fluency Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93400|NCT00871715|Secondary|Short Blessed Memory Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93401|NCT00871715|Secondary|Confidence in Arm & Hand Movement (CAHM)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93402|NCT00871715|Secondary|EQ5D|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93403|NCT00871715|Secondary|Single-Item Subjective Quality of Life Measurement (SQOL)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93404|NCT00871715|Secondary|Reintegration to Normal Living Index (RNLI)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
94170|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
93410|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Strength Components|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93411|NCT00871715|Secondary|Arm Muscle Torque Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93412|NCT00871715|Secondary|National Institute of Health Stroke Scale (NIHSS)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||08/2016||||
93413|NCT00871715|Primary|Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization)|The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||percentage of participants|||Number
93414|NCT00871715|Primary|Stroke Impact Scale (SIS) Hand Function Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||units on a scale||95% Confidence Interval|Mean
93415|NCT00871715|Primary|Wolf Motor Function Test Time|Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||seconds||95% Confidence Interval|Mean
93416|NCT00871715|Primary|Wolf Motor Function Test (WMFT) Log-transformed Time|Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.||seconds||95% Confidence Interval|Mean
93417|NCT00871689|Secondary|Number of Patients With Successful Natural Killer Expansion|Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl.|Day 72 Post Transplant|||participants|||Number
93418|NCT00871689|Secondary|Median Overall Survival|Average number of days the patients were alive after receiving UCB transplantation.|Month 6|||Days||Full Range|Median
93419|NCT00871689|Primary|Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant|||participants|||Number
93420|NCT00871689|Secondary|Number of Patients With Complete Remission of Disease|Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis).|Day 100|||Participants|||Number
93421|NCT00871689|Secondary|Number of Patients With Transplant-Related Death (TRD)|Number of patients whose death is related to study treatment received. TRD is defined as the number of patients that die without prior relapse.|1 Year Post Transplant|||Participants|||Number
93422|NCT00871689|Secondary|Number of Patients With Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant|||participants|||Number
93423|NCT00871689|Secondary|Incidence of Primary Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42.|Day 42|||Participants|||Number
93424|NCT00871689|Primary|Number of Patients With Neutrophil Engraftment|Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.|Day 42|||Participants|||Number
93425|NCT00871624|Secondary|Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive||Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study||||||
93426|NCT00871624|Primary|Tolerability of NIV as Assessed by an NIV Tolerance Score|NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours)|Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours|||percentage of time spent tolerant to NIV||Inter-Quartile Range|Median
94115|NCT00863356|Primary|This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.||Removal: 48 hours. Follow-up: 1 week.||||||
93427|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."||percentageof participants||95% Confidence Interval|Number
93428|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
93429|NCT00871494|Secondary|Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
93430|NCT00871494|Primary|Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
93431|NCT00871429|Secondary|Percentage of Subjects With Skin Toxicity Grades 0 to 5 Using The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 at Baseline Visit and 1 Month Follow-up After Using Lindi Products.||one month||||||
93432|NCT00871429|Primary|Product Satisfaction of the Following Test Articles A, B, and C: Lindi Skin Soothing Balm (Product A), Lindi Skin Face Serum (Product B), and Lindi Skin Face Wash (Product C)||one month of use|the number of participants for analysis was determined per protocol.||Percentage of Participants|||Number
93433|NCT00871403|Secondary|Percentage of Participants With a Complete Response or a Partial Response|The percentage of participants with a complete response or a partial response was evaluated.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population||percentage of participants|||Number
93434|NCT00871403|Secondary|Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only|Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population. A participant without a post-baseline assessment of response was considered to be a non-responder; i.e., all randomized participants are included in the denominator.||participants|||Number
93435|NCT00871403|Secondary|Overall Survival (OS)|OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.|Randomization until death (up to 85 weeks)|ITT Population|||||
93450|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PSC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93436|NCT00871403|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).|Randomization until progression or death (up to 85 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.||weeks||95% Confidence Interval|Median
93437|NCT00871377|Primary|Seizure Frequency|Seizure frequency (seizures per day or seizures per month)|Study completion (42 weeks)|||Seizures per Day||Standard Error|Mean
93438|NCT00871351|Secondary|Percent Change in Total Lipids and Hs-CRP|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).|End of washout to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
93439|NCT00871351|Secondary|Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.|End of Week 4 to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
93440|NCT00871351|Secondary|Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values|"LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).~Target values:~For participants with history of coronary artery disease: <100 mg/dL;~for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;~for participants with 1-2 CV risk factors: <140 mg/dL;~for participants with no CV risk factors: <160 mg/dL."|Week 16 or discontinuation|Randomized participants||Participants|||Number
93441|NCT00871351|Secondary|Percent Change in LDL-C|LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).|End of washout period to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
93442|NCT00871351|Primary|Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values|LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).|End of Week 4 to Week 16 or discontinuation|Randomized participants||Percent change||95% Confidence Interval|Mean
93443|NCT00871338|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.||Subjects|||Number
93444|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.||Subjects|||Number
93445|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.||Subjects|||Number
93446|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.||Subjects|||Number
93447|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.||Subjects|||Number
93448|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.||Subjects|||Number
93449|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.||Subjects|||Number
93451|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PRP Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93452|NCT00871338|Secondary|Number of Subjects With a Booster Response to rSBA-MenC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93453|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||titers||95% Confidence Interval|Geometric Mean
93454|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||EL.U/mL||95% Confidence Interval|Geometric Mean
93455|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||IU/mL||95% Confidence Interval|Geometric Mean
93456|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||µg /mL||95% Confidence Interval|Geometric Mean
93457|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||titers||95% Confidence Interval|Geometric Mean
93458|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||µg /mL||95% Confidence Interval|Geometric Mean
93459|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93460|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93461|NCT00871338|Secondary|Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93462|NCT00871338|Secondary|Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
94171|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
93463|NCT00871338|Secondary|Number of Seropositive Subjects Against rSBA-MenC.|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93464|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-PRP.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.||Subjects|||Number
93465|NCT00871338|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||µg/mL||95% Confidence Interval|Geometric Mean
93466|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||titers||95% Confidence Interval|Geometric Mean
93467|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||EL.U/mL||95% Confidence Interval|Geometric Mean
93468|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||IU/mL||95% Confidence Interval|Geometric Mean
93469|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||µg/mL||95% Confidence Interval|Geometric Mean
93470|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||titers||95% Confidence Interval|Geometric Mean
93471|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||µg/mL||95% Confidence Interval|Geometric Mean
93472|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93473|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93474|NCT00871338|Secondary|Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93475|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93476|NCT00871338|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93477|NCT00871338|Secondary|Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.|The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93478|NCT00871338|Primary|Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93479|NCT00871338|Primary|Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.||Subjects|||Number
93480|NCT00871286|Primary|Number of Participants Having a CT Done|Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.|8 weeks|Per protocol; this was a nonpowered convenience sample||participants|||Number
93481|NCT00871286|Primary|Number of Participants in Compliance With Medical Recommendations|Number of participants in each group who complied with medical advice given at the initial appointment.|8 weeks|||participants|||Number
93482|NCT00871234|Secondary|Endothelial Activation Biomarkers||Four weeks||||||
93483|NCT00871234|Secondary|Inflammatory Biomarkers||Four weeks||||||
93484|NCT00871234|Secondary|Blood Pressure||Four weeks||||||
93485|NCT00871234|Secondary|Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]||Four weeks||||||
93486|NCT00871234|Secondary|Lipid Fractions||Four weeks||||||
93487|NCT00871234|Primary|Flow-mediated Dilation (FMD) of the Brachial Artery|FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.|Entry and four weeks|FMD analysis was per protocol restricted to those who completed the four week trial. The safety analysis was ITT.||Percentage||Inter-Quartile Range|Median
93488|NCT00871169|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events, and Serious Adverse Events (SAEs)).|2 years|||participants|||Number
93489|NCT00871169|Primary|Overall Response Rate (ORR)|ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. ORR is the percentage of patients who experienced a CR + the percentage of patients who experienced a PR.|2 years|||percentage of participants||95% Confidence Interval|Number
93490|NCT00871143|Secondary|Body Image Quality of Life Inventory (BIQLI)|The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from –3 (‘very negative effect’) to +3 (‘very positive effect’); Cronbach’s α for the scale is 0.95.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
93491|NCT00871143|Secondary|Generalised Anxiety Disorder (GAD)-7|The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach’s α for the measure is 0.92.|12 weeks,1 month post treatment|||units on a scale||Standard Deviation|Mean
93492|NCT00871143|Secondary|Patient Health Questionnaire (PHQ)-9|The PHQ is a 9-item self-report measure of depression; each item is scored from 0 (‘not at all’) to 3 (‘nearly every day’),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach’s α for the scale is 0.89.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
93493|NCT00871143|Secondary|Appearance Anxiety Inventory (AAI)|The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 (‘not at all’) to 4 (‘all the time’), and the range of the total scores is 0–40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach’s α of 0.86.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
93494|NCT00871143|Secondary|Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).|MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating ‘normal’ or ‘no difficulties’) to 6, and the range is 0–60; higher scores reflect a greater symptomatology; a MADRS total score of ≥ 25 is regarded as moderate, and of >31 as severe.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
93495|NCT00871143|Secondary|Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)|BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. ‘I am as ugly as the Elephant man’); each item is rated from 0 (‘non-delusional belief, or least pathological’) to 4 (‘delusional belief, or most pathological’) and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
93496|NCT00871143|Primary|Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)|This is a clinician-rated scale administered by a trained blinded assessor. The range is 0–48. Cronbach’s α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to ‘much improved’ on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.|12 weeks, 1 month post treatment|||units on a scale||Standard Deviation|Mean
93497|NCT00871117|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 to 6 months post-vaccination)|Analysis was performed on the total vaccinated cohort.||subjects|||Number
93498|NCT00871117|Secondary|Number of Subjects With Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|Analysis was performed on the total vaccinated cohort.||subjects|||Number
93499|NCT00871117|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included fever (temperature equal to or greater than 37.5 degrees Celsius), drowsiness and loss of appetite.|Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|The analysis was performed the total vaccinated cohort on subjects with at least one vaccine administration documented and with available data.||subjects|||Number
93500|NCT00871117|Primary|Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3|Titers are expressed as GMTs.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||titer||95% Confidence Interval|Geometric Mean
93501|NCT00871117|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL)|"anti-PT, anti-FHA and anti-PRN booster response :~initially sero- (pre-booster antibody concentration below cut-off < 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL)~initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and < 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster~initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
93502|NCT00871117|Secondary|Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Seropositivity was defined as a concentration greater than or equal to 5.0 EL.U/mL|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
93503|NCT00871117|Secondary|Number of Subjects Protected Against Poliovirus 1, 2 and 3|"Seroprotection was defined:~* anti-poliovirus type 1, 2 or 3 antibody titer greater than or equal to 8 ED50.~ED50 is defined here as the reverse of the dilution resulting in 50% inhibition."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
93504|NCT00871117|Secondary|Number of Subjects Seroprotected Against Diphteria and Tetanus|"Seroprotection status was defined as:~anti-D antibody concentration greater than or equal to 0.1 IU/mL~anti-T antibody concentration greater than or equal to 0.1 IU/mL"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
93516|NCT00870740|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.|Up to 72 Weeks|Number of participants in the safety population (all randomized participants who received study treatment) with at least one post-baseline value.||participants|||Number
93505|NCT00871117|Secondary|Number of Subjects With an Anti-polio 1, 2, 3 Booster Response|"Anti-poliovirus 1, anti-poliovirus 2 and anti-poliovirus 3 booster response:~initially seronegative subjects (pre-booster antibody titer below cut-off of 8 ED50) with an antibody titer ≥ 32 ED50 one month after vaccination~initially seropositive subjects (pre-booster antibody titers ≥ 8 ED50) with an increase at least four times the pre-booster antibody titer one month after vaccination.~ED50 is defined here as the reverse of the dilution resulting in 50% inhibition. The lowest dilution at which serum samples were tested is 1:8 from which a test was considered positive."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
93506|NCT00871117|Secondary|GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies|Concentrations are expressed as GMCs in Enzyme-Linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
93507|NCT00871117|Secondary|Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies|Concentrations were expressed as GMCs in IU/mL.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
93508|NCT00871117|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value|Cut-off value was defined as greater than or equal to 1.0 international units per milliliter (IU/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
93509|NCT00871117|Primary|Number of Subjects With Booster Responses to Diphteria and Tetanus|"Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as:~initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of < 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL)~initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
93510|NCT00870896|Secondary|Change in FEV1/FVC Ratio|We measured the change in FEV1/FVC ratio at baseline and following 30 days of treatment with Spiriva.Change in ratio reflects the percentage value (ratio) at 30 days minus the percentage value (ratio) at baseline x 100|30 days|||percentage change||Standard Deviation|Mean
93511|NCT00870896|Secondary|Change in FEV1 (in Liters)|Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.||liters||Standard Deviation|Mean
93512|NCT00870896|Primary|Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days)|We measured the change in the number of coughs following capsaicin inhalation challenge from baseline followed by 30 days of treatment with spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.||coughs per dose of capsaicin||Standard Deviation|Mean
93513|NCT00870740|Secondary|Rate of Percentage Change From Baseline in Mean Total Brain Volume|Total brain volume was measured by MRI and analyzed by a central reader. Rate of percentage change from baseline calculated using an analysis of covariance adjusting for baseline normalized brain volume. Baseline values = baseline for study 205MS202 (NCT00870740). Missing values post-baseline were imputed using the average value across subjects in the treatment group.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.||rate of percentage change||95% Confidence Interval|Number
93514|NCT00870740|Primary|Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline|Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|All participants in the Safety Population (all randomized participants who received study treatment) with a post-baseline ADAb assessment.||participants|||Number
93515|NCT00870740|Primary|Number of Participants With Abnormalities in Blood Chemistry Laboratory Data|For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.|Up to 72 Weeks|Safety Population: all randomized participants who received study treatment; n=number of participants whose baseline value for 205MS202 (NCT00870740) was normal (i.e. not high or low) and who had at least one post-baseline value during the study.||participants|||Number
93517|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all participants within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.||percentage change in volume||Standard Deviation|Mean
93518|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T2 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.||percentage change in volume||Standard Deviation|Mean
93519|NCT00870740|Secondary|Mean Volume of New T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline is volume of new T1 hypointense lesions since baseline in study 205MS201 (NCT00390221). Scans at Week 20 and Week 52 in 205MS202 are relative to baseline in 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 20, Week 52|Per-protocol population: randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days; n=participants with measurement at given time point.||mm^3||Standard Deviation|Mean
93520|NCT00870740|Secondary|Mean Number of New or Newly-enlarging T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. New or newly enlarging T2 lesions since baseline of study 205MS202 (NCT00870740). For post-baseline visits, the number of T2 lesions may be imputed using the mean value across all participants within the treatment group, if the participant has non-missing baseline data. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Baseline, Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||lesions||Standard Deviation|Mean
93521|NCT00870740|Secondary|Mean Number of New Gadolinium-enhancing Lesions|Evaluated by magnetic resonance imaging (MRI) by a central reader. Number of new Gd lesions since the previous scan (the previous scan for Week 20 was Week 52 of study 205MS201 [NCT00390221]). The number of Gd lesions may be imputed using last observation carried forward or using the mean value across all subjects within the treatment group. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||lesions||Standard Deviation|Mean
93522|NCT00870740|Secondary|Estimated Proportion of Participants With a Relapse|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the INEC. Estimated using Kaplan-Meier analysis where time to first relapse is calculated from date of first dose in the study to date of first confirmed relapse. Participants who received an alternative MS medication before the first relapse were censored at the time of taking the alternative MS medication.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||proportion of participants|||Number
93523|NCT00870740|Secondary|Adjusted Annualized Relapse Rate|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Independent Neurology Evaluation Committee (INEC). Relapse rate is calculated as: (Total number of relapses that occurred during the 205MS202 [NCT00870740] treatment phase divided by the total number of days followed in the treatment phase for 205MS202), multiplied by 365 days. Participants who received an alternative multiple sclerosis (MS) medication during 205MS201 (NCT00390221; Year 1) are not included in the summary of relapses and relapse rate for this study (Year 2). Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.||relapses per person-years||95% Confidence Interval|Number
93610|NCT00869609|Secondary|Change in HDL Cholesterol|High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.||mg/dl||Standard Deviation|Mean
93524|NCT00870740|Primary|Number of Participants With Abnormalities in Vital Signs|For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.|Up to Week 72|Safety population: all randomized participants who received study treatment; n=number of subjects who had a baseline assessment and at least one post-baseline assessment for that vital sign.||participants|||Number
93525|NCT00870740|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.|Up to 72 weeks|Safety population: all randomized participants who received study treatment. Participants who discontinued study treatment due to an AE and/or withdrew from the study due to an AE that started prior to 205MS202 (NCT00870740) and that was treatment-emergent under 205MS201 (NCT00390221) are included in this summary.||participants|||Number
93526|NCT00870688|Primary|Number of Seizures Within 7 Weeks||7 weeks|||seizures||Standard Deviation|Mean
93527|NCT00870688|Secondary|Data About Efficacy, Safety and Compliance||7 weeks||||||
93528|NCT00870688|Primary|Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily||7 weeks||||||
93529|NCT00870584|Secondary|Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks|"The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study? The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment."|24 weeks|Full Analysis Set||participants|||Number
93530|NCT00870584|Primary|Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.|Baseline and 24 weeks|"The Full Analysis Set consisted of patients to whom study drug had been assigned through randomization. Patients inappropriately randomized were excluded from this analysis set.~Participants with observations at both baseline and 24 weeks were included in the analysis."||Score on a scale||Standard Deviation|Mean
93531|NCT00870545|Secondary|Family Communication|Family communication measured with the Family Problem Solving Communication scale at baseline, six and 12 months. Scores range from 0-30 with higher scores indicating better communication.|baseline, 6 months, and 12 months|All participants with family communication data at baseline, six and 12 months.||units on a scale||Standard Deviation|Mean
93532|NCT00870545|Secondary|Spouse Social Support|Support measured with the Social Support Index at baseline, six and 12 months. Scores range from 0-68 with higher scores indicating better social support.|baseline, 6 months, and 12 months|All participants with social support data at baseline, six and 12 months.||units on a scale||Standard Deviation|Mean
93533|NCT00870545|Primary|Quality of Marriage|Measure of marriage quality using Quality Marriage Index at baseline, six and 12 months. Scores range from 6-45 with higher scores indicating better quality of marriage.|Baseline, 6 and 12 months|All participants with quality marriage index scores at the three time points||units on a scale||Standard Deviation|Mean
93534|NCT00870545|Primary|Anxiety|Anxiety measured with the Generalized Anxiety Disorder -7 (GAD-7)measured at baseline, six and 12 months. Scores range from 0-21, with lower scores indicating fewer anxiety symptoms.|baseline, 6 months and 12 months|All participants with anxiety scores at 12 months||units on a scale||Standard Deviation|Mean
93535|NCT00870545|Secondary|Family Coping|Family problem solving measured at baseline, six and 12 months with the F-COPES measure. Scores range from 29-145 with higher scores indicating better coping.|Baseline, 6 months and 12 months|All participants with family coping data at baseline, six and 12 months.||units on a scale||Standard Deviation|Mean
93536|NCT00870545|Primary|Spouse Self-report of Depression|Depression measured with the Patient Health Questionnaire (PHQ)-9 at baseline, six and 12 months. Scores range from 0-27 with lower scores indicating less depressive symptoms.|Baseline, 6 months, and 12 months|All participants with depression data at baseline, six and twelve months||units on a scale||Standard Deviation|Mean
93537|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.|Through Week 52|Participants who received at least 1 dose of adalimumab during the study.||participants|||Number
93538|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
93539|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||units on a scale||Standard Deviation|Mean
93540|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
93541|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
93542|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||participants|||Number
93543|NCT00870467|Secondary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 52|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 52|Participants who completed 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.||units on a scale||Standard Deviation|Mean
93544|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.|Through Week 26|All participants who received at least 1 dose of double-blind study drug.||participants|||Number
93545|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
93546|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Last observation carried forward (LOCF) was used for missing data.||units on a scale||Standard Deviation|Mean
93547|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
93708|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
93548|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
93549|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.||participants|||Number
93550|NCT00870467|Primary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 26|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Analysis performed using observed cases; no imputation technique used. Participants who switched to open-label adalimumab before Week 26 were excluded from the analysis.||units on a scale||Standard Deviation|Mean
93551|NCT00870363|Secondary|Immune Reconstitution With Respect to Absolute Numbers of CD4+ T-cells, the Relative Proportion of T-cell Subpopulations in the Tissue, and Immune Activation to a Cohort of Normal Controls||nine months|data was not collected/analyzed due to complications in the assays for immune activation in the collected samples|||||
93552|NCT00870363|Secondary|Changes in CD4+ T-cell Numbers by Treatment Regimen|peripheral absolute CD4+ T-cell counts increase from baseline to 9 months of cART by commercial assay|Baseline and nine months|peripheral CD4 T-cell counts were not measured in the HIV negative cohort||cells/mL||95% Confidence Interval|Mean
93553|NCT00870363|Secondary|Lymphocyte Immune Function and Activation at Two Time Points Approximately Nine Months Apart in GALT; and Four Timepoints (Month 0, 3, 6, and 9) in Peripheral Blood||nine months|data were not collected due to inadequate sample volume for this complex experiment design|||||
93554|NCT00870363|Secondary|Change in GALT CD4+ and CD8+ T-cell Subpopulations (naïve and Memory Subsets)||nine months|data were not collected due to the samples not being suitable for the epitopes being measured|||||
93555|NCT00870363|Secondary|Change in HIV DNA Per 10^6 Cells in Duodenal Tissue Versus PBMC by Drug Regimen Received|single-cell suspension of digested duodenal tissue and Ficol-Hypaque separated PBMC underwent HIV-DNA PCR|Baseline and nine months|HIV negative controls did not have HIV-DNA in blood or tissue||copies/10^6 cells||95% Confidence Interval|Mean
93556|NCT00870363|Secondary|Trough Plasma and Tissue Drug Levels in Volunteers at the Time of the Upper Endoscopy|The reported drug level is for the primary ART agent for that cohort. For the maraviroc arm, maraviroc plasma and tissue levels are reported. For the maraviroc plus raltegravir arm, the raltegravir plasma and tissue levels are reported. For the efavirenz arm, the efavirenz plasma and tissue levels are reported. HIV negative controls were not on ART and did not have drug levels measured.|nine months|HIV negative controls were not on ART and did not have drug levels measured.||ng/mL||Inter-Quartile Range|Median
93557|NCT00870363|Primary|Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen|immunohistochemistry for CD3+/CD4+ cells counted manually within the lamina propria|Baseline and nine months for 3 treatment cohorts and Baseline for the control group, which was only assessed at one time point|numbers represent an increase from baseline for the 3 treatment cohorts and represent the absolute value for the control group who were only measured at one timepjoint.||cells/mm^2||95% Confidence Interval|Mean
93558|NCT00870194|Secondary|Incidence of Confirmed Hypoglycemia(Overall)|Incidence of confirmed hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; has a concurrent fingerstick blood glucose <3.0 mmol/L (54 mg/dL).||Participants|||Number
93559|NCT00870194|Secondary|Incidence of Nocturnal Hypoglycemia (Overall)|Incidence of nocturnal hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients||Participants|||Number
93560|NCT00870194|Secondary|Incidence of Severe Hypoglycemia(Overall)|Incidence of severe hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Severe hypo:symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose;or documented hypoglycemia (BG< 3.0 mmol/L [54/mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior||Participants|||Number
93561|NCT00870194|Secondary|Incidence of Hypoglycemia (Overall)|Incidence of hypoglycemic episodes experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; not confirmed with blood glucose values.||Participants|||Number
93709|NCT00868192|Post-Hoc|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
93562|NCT00870194|Secondary|Change in Total Cholesterol (mmol/L)|Change in total cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
93563|NCT00870194|Secondary|Change in LDL (mmol/L)|Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
93564|NCT00870194|Secondary|Change in HDL (mmol/L)|Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
93565|NCT00870194|Secondary|Change in Triglycerides (mmol/L)|Change in triglycerides from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
93566|NCT00870194|Secondary|SMBG (mmol/L)|7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
93567|NCT00870194|Secondary|Waist-to-Hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (Week20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Ratio||Standard Error|Least Squares Mean
93568|NCT00870194|Secondary|Change in Waist Circumference (cm)|Change in waist circumference from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||cm||Standard Error|Least Squares Mean
93569|NCT00870194|Secondary|Change in Body Weight (kg)|Change in body weight from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||kg||Standard Error|Least Squares Mean
93570|NCT00870194|Secondary|Change in FSG (mmol/L)|Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||mmol/L||Standard Error|Least Squares Mean
93571|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 6.5%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percentage|||Number
93572|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <7.0%|Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was >= 7.0%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percentage|||Number
93573|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=7.0%|Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 7.0%; Last Observation Carried Forward.Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percentage|||Number
93574|NCT00870194|Primary|Change in HbA1c (Percent)|Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.||Percent HbA1c||Standard Error|Least Squares Mean
93575|NCT00870103|Primary|The Percentage of Patients With no Ocular Pain||Day 15 after cataract surgery|||Percentage of participants|||Number
93576|NCT00870103|Primary|The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.|"The percentage of patients with a score of zero for Anterior chamber cells.~Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).~Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon"|Day 15 after cataract surgery|||Percentage of participants|||Number
93588|NCT00869947|Secondary|Trailing Leg Step-to-step Transition Work|We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg).|1 year|||J/kg||Standard Error|Mean
93589|NCT00869947|Secondary|Preferred Walking Velocity|We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable.|1 year|||m/s||Standard Deviation|Mean
93577|NCT00869999|Primary|Overall Response Rate|Complete response plus partial response after 6 cycles. Response rate will be evaluated by using the modified Cheson criteria for lymphoma response. Complete response requires all of the following: 1) PET positive prior to therapy: mass of any size permitted if PET negative. Variable FDG-avid or PET negative prior to therapy: regression to normal size on CT (</= 1.5cm in their greatest transverse diameter for nodes >/= 1.5 cm before therapy) 2) Spleen (if enlarged before therapy) must have regressed in size and must not be palpable, 3) If bone marrow is known to be involved, repeat biopsy documents clearance. Partial response requires 1) >/= 50% decrease in SPD, 2) No new sites of disease or increase in the size of other nodes, liver or spleen, 3) Splenic and hepatic nodules must regress by at least 50% in SPD|Assessed at the conclusion of cycle 2, cycle 4 and cycle 6|||percentage of participants||90% Confidence Interval|Number
93578|NCT00869999|Secondary|Progression-free Survival|Progression-free survival is defined as the duration of time from start of treatment to time of documentation of progression or death|2 years|||months||90% Confidence Interval|Median
93579|NCT00869999|Secondary|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.|2 years|||months||90% Confidence Interval|Median
93580|NCT00869960|Primary|Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93581|NCT00869960|Primary|Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93582|NCT00869960|Primary|Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93583|NCT00869960|Primary|Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93584|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93585|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93586|NCT00869960|Primary|Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|between time of dosing tp 24 hours after dose administration|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93587|NCT00869960|Primary|Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|between time of dosing to 24 hours after dose administered|The number was determined based upon the those women who completed the study.||mg*h/L||Standard Deviation|Mean
93590|NCT00869947|Primary|Metabolic Cost of Transport|We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm).|1 year|||J/Nm||Standard Deviation|Mean
93591|NCT00869778|Secondary|Change From Baseline by Visit for Serum HBV DNA|Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values|week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||IU/mL||Standard Deviation|Mean
93592|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
93593|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
93594|NCT00869778|Secondary|Change From Baseline by Vist for HBeAg Titer|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population||IU/mL||Standard Deviation|Mean
93595|NCT00869778|Secondary|The Proportion of Patients With Positive Anti-HBe||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population||percentage of participants|||Number
93596|NCT00869778|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb;||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population||percentage of participants|||Number
93597|NCT00869778|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
93598|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
93599|NCT00869778|Secondary|Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication|serology response at week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population||percentage of participants|||Number
93600|NCT00869778|Primary|Percentage of Participants With HBeAg Seroconversion at Endpoint|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint|Intention-To-Treat Population||percentage of participants|||Number
93601|NCT00869622|Secondary|Vertebral Fractures||2 years|||Vertebral Fractures|||Number
93602|NCT00869622|Primary|Changes in Bone Mineral Density|"Patients with a T-Score of > -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D.~Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals."|2 years|The study design involved 80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate. This is a prospective study in which 80 patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.||g/cm2||Standard Deviation|Mean
93603|NCT00869609|Secondary|Change in Waist Circumference|Waist circumference was measured at the midpoint between the lower rib margin and the iliac crest; the measurement was repeated twice and the average computed.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||inches||Standard Deviation|Mean
93604|NCT00869609|Secondary|Change in Diastolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mmHg||Standard Deviation|Mean
93605|NCT00869609|Secondary|Change in Systolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mmHg||Standard Deviation|Mean
93606|NCT00869609|Secondary|Change in Glycosylated Hemoglobin A1c (HbA1c)|Collected via venous blood draw, the HbA1c level reflects glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides an indication of long-term glycemic control.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
93607|NCT00869609|Secondary|Change in Fasting Glucose|Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mg/dl||Standard Deviation|Mean
93608|NCT00869609|Secondary|Change in Triglycerides|Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.||mg/dl||Standard Deviation|Mean
93609|NCT00869609|Secondary|Change in LDL Cholesterol|Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.||mg/dl||Standard Deviation|Mean
93611|NCT00869609|Secondary|Change in Total Cholesterol|Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.||mg/dl||Standard Deviation|Mean
93612|NCT00869609|Primary|Change in Weight|Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Intention to treat analyses were performed; for those with missing weights at the post-intervention, 8 and 12 month visits, the last documented observation was carried forward. This information was available from the session data, where weight was collected weekly.||pounds||Standard Deviation|Mean
93613|NCT00869557|Secondary|The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL|The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.|Baseline to Weeks 24 and 48|ITT analysis set||percentage of participants|||Number
93614|NCT00869557|Secondary|Change From Baseline in CD4 Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to Week 48|ITT analysis set; M = E analysis (all missing data were excluded from the analysis).||cells/µL||Standard Deviation|Mean
93615|NCT00869557|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24|Change = Week 24 value minus baseline value|Baseline to Week 24|ITT analysis set. M = E analysis (all missing data were excluded from the analysis).||cells/µL||Standard Deviation|Mean
93616|NCT00869557|Secondary|Change From Baseline in HIV-1 RNA (log_10 Copies/mL)|Change = Week 24 or 48 value minus baseline value|Baseline to Weeks 24 and 48|ITT analysis set; The missing = excluded (M = E) analysis method was used in which all missing data were excluded from the analysis.||log_10 copies/mL||Standard Deviation|Mean
93617|NCT00869557|Secondary|The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|Week 48|ITT analysis set; M = F analysis (all missing data were considered as failure [HIV-1 RNA ≥ 50 copies/mL]).||percentage of participants|||Number
93618|NCT00869557|Primary|The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.|Week 24|ITT analysis set (all participants who were randomized into the study and received at least 1 dose of study drug). The missing = failure (M = F) analysis method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).||percentage of participants|||Number
93619|NCT00869518|Secondary|Recurrent Skin and Skin Structure Infections (SSTI)|recurrent SSTI was by self-report and exam, followed until positive colonization|up to 30 days following completion of treatment|participants were followed until colonization; therefore, no participants were followed past 30 days||participants|||Number
93620|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|60 days following completion of treatment|Participants were colonized at day 30 (i.e. S. Aureus not eradicated) and were not checked again for follow-up.|||||
93621|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|7 days following completion of treatment|||participants|||Number
93622|NCT00869518|Primary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|30 days following completion of treatment|||participants|||Number
93623|NCT00869375|Primary|Incidence of Bleeding Complications||24 hours after the procedure|||participants|||Number
93624|NCT00869375|Primary|Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence||24 hours after the procedure|||participants|||Number
93625|NCT00869362|Secondary|Average Intervention Effect Over 12 Months After Hospital Discharge||12 months from discharge|||HbA1c, %||Standard Error|Mean
93626|NCT00869362|Primary|Hemoglobin A1c|Change in glycemic control measured by HbA1c change baseline to 6 months|6 months from discharge|||HbA1c, %||Standard Deviation|Mean
93627|NCT00869258|Primary|Conversion Rate of Inoperable to Operable|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks||||||
93628|NCT00869167|Primary|Insomnia Severity Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.~PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|5 weeks|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||units on a scale||Standard Deviation|Mean
93629|NCT00869167|Secondary|Daytime Lung Function (Peak Flow Monitoring) in Liter/Min||baseline and during treatment period (during 5th week)|This measure was added during the study and no subjects completed the measure.|||||
93630|NCT00869167|Secondary|Daytime Performance (Digit Symbol Substitution Test)|"DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters.~DSST score can range from 0-125, with 125 being the most number correct during the allotted time period."|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||Number correct||Standard Deviation|Mean
93631|NCT00869167|Secondary|Daytime Sleepiness (Epworth Sleepiness Scale)|Score of 0-24, with 24 being the most sleepy|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||units on a scale||Standard Deviation|Mean
93632|NCT00869167|Primary|Pittsburgh Sleep Quality Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.~PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.||units on a scale||Standard Deviation|Mean
93710|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|12 months|||percentage of participants||95% Confidence Interval|Number
93633|NCT00869141|Primary|Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase|intraocular pressure of eyes with hypertensive phase versus without hypertensive phase|1 year after surgery|Please note that these two groups were different from those groups in previous comparison. The patients that developed hypertensive phase were compared to those that did not developed hypertensive phase, so the number of patients in these two groups and the mean pressure at 1 year +/-standard deviation results were different.||mmHg in 1 year postop||Standard Deviation|Mean
93634|NCT00869141|Primary|Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma|intraocular pressure comparison between groups after the Ahmed valve implantation|3 weeks after surgery|Eye pressure at postop 3-week is reported||mmHg at postop 3-week||Standard Deviation|Mean
93635|NCT00869141|Primary|Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma|Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week|within 6 months after surgery|||participants|||Number
93636|NCT00869128|Primary|Sleep Efficiency|Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period|3 weeks|ITT||Percentage of time asleep||Standard Deviation|Mean
93637|NCT00869089|Primary|Improvement in Prurigo Nodularis||24 weeks|Subjects who completed the study were analyzed.||participants|||Number
93638|NCT00869050|Primary|Number of Participants With Complete Response (CR)|CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.|12 months|28/38 analyzed.||participants|||Number
93639|NCT00869050|Primary|Number of Participants With Partial Response (PR)|PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.|12 months|28/38 analyzed.||participants|||Number
93640|NCT00868998|Secondary|Toxicity|Data was not analyzed due to poor accrual.|Prior to day 4 and on day 12||||||
93641|NCT00868998|Primary|Response Rate|Data was not analyzed due to poor accrual.|10 weeks||||||
93642|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity."|24 weeks|||units on a scale||Standard Deviation|Mean
93643|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a clinician-rated assessment of the subject’s level of depression. Ten items are rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|24 weeks|||units on a scale||Standard Deviation|Mean
93644|NCT00868959|Primary|Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment|Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)|24 weeks|||participants|||Number
93645|NCT00868790|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.||Participants|||Number
93646|NCT00868790|Primary|Number of Participants With At Least One Adverse Event (AE) in the Treatment or Post-Treatment Periods|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.||Participants|||Number
93647|NCT00868790|Secondary|Percentage Change From Baseline (BL) After 4-Week Treatment in Low-Density Lipoprotein C (LDL-C) Levels|Blood samples were obtained from all participants to measure LDL-C levels at Week 0 (Baseline) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit). For each visit, LDL-C was measured over 2 days. The average of duplicate measurements (when available) was used in the analysis.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit|All randomized participants who took at least 1 dose of study treatment and had a valid reading at timepoint.||percentage change from BL||90% Confidence Interval|Least Squares Mean
93711|NCT00868192|Secondary|Association Between Levels of Thymidylate Synthase, Dihydrofolate Reductase, and Glycinamide Ribonucleotide Formyl Transferase and Ovarian Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.|||||
93648|NCT00868790|Secondary|Change From BL After 4-Week Treatment in 2-hour Post-Meal Glucose (PMG) Levels|Two-hour PMG was analyzed in both non-domiciled and domiciled participants. Non-domiciled participants completed a 3-point meal tolerance test (MTT) at Week 0 (Baseline) and Week 4 Visits of Treatment Period 1. Participants completed 12-hr fasting prior to the Week 0 (Baseline) and Week-4 clinic visits. Fasting blood samples were obtained at the beginning of these clinic visits, after which participants consumed a standardized meal (1 nutrition bar and 1 can of nutrition drink), and then completed the MTT, in which plasma glucose was measured at 30 min and 120 min (2 hr) post-meal. The 2-hr PMG data also include data from domiciled participants, based on 2-hr post-morning meal glucose levels in the 24-hr blood glucose sample at the Week 4 and Week 8 Visits. The 2-hour PMG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in 2-hour PMG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 visit|All randomized participants receiving ≥1 dose of therapy and having MTT measurement either at Week 0 (BL) or end of Treatment Period 1. N=number of participants included in the Longitudinal Data Analysis (LDA) model||mg/dL||Standard Error|Least Squares Mean
93649|NCT00868790|Secondary|Change From Baseline (BL) After 4-Week Treatment in Fasting Plasma Glucose (FPG)|Fasting blood samples were obtained during study site visits at Baseline (Week 0 Visit) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit). Participants were counseled to fast (no food or drink except water and non-study medications, as directed) for at least 12 hours prior to all study visits. FPG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in FPG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit|All randomized participants receiving ≥1 dose of therapy and having FPG measurement either at BL or end of Treatment Period. Number of Participants Analyzed=number of participants included in the LDA model.||mg/dL||Standard Error|Least Squares Mean
93650|NCT00868790|Primary|Change From Baseline (BL) After 4-Week Treatment in Weighted Mean Glucose (WMG)|The primary efficacy outcome in this study was the assessment of 24-hour weighted mean glucose (WMG) levels for domiciled participants after 4-week treatment (Periods 1 and 2 only). At selected study sites, a subset of participants domiciled (stayed) overnight and underwent 24-hour blood sampling at the Week 0 Visit (Baseline), Week 4 Visit (end of Period 1), and Week 8 Visit (end of Period 2). Domiciled participants were not expected to follow a weight-maintaining diet while receiving standard meals from a dietician or licensed healthcare professional. WMG was calculated as the weighted average value of the glucose from the 24-hour blood sample (for Baseline, Week 4, and Week 8) and analyzed using a Longitudinal Data Analysis (LDA) model. Results were expressed as the change from baseline after 4-week treatment in 24-hour WMG.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit|All randomized domiciled participants receiving ≥1 dose of therapy and having 24-hour WMG measurement either at BL or end of Treatment Period 1 or 2. Number of Participants Analyzed=number of participants included in LDA model. Participants in MK-3577 25 mg BID group did not undergo 24-hour glucose sampling and were not analyzed.||mg/dL||Standard Error|Least Squares Mean
93651|NCT00868712|Secondary|International Normalized Ratio|The International Normalized Ratio (INR) is a standardized lab value that measures the intensity of anticogulation using warfarin. It is used to monitor patients taking warfarin.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.|||ratio||Standard Deviation|Mean
93652|NCT00868712|Primary|Coronary Calcification (Presence and Degree as Measured by Agatston Score) Attributed to Duration of Warfarin Use in Months After Controlling for Standard Cardiovascular Risk Factors to Include the Framingham Risk Score|The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; >1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.|After interim analysis following n=70 showed no effect, further enrollment was halted.||Agatston Score||Standard Deviation|Mean
93653|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|"Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.~The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items."|Baseline to Week 6|Intent-to-treat population is analyzed. Number of participants in table is not consistent with intent-to-treat population because: if one or more items are missing at a study visit, as can occur when a subject opts out of the work/school item because it does not apply, the authors of the scale recommend setting the total score to missing||units on a scale||Standard Error|Least Squares Mean
93654|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.~The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome."|Baseline to Week 6|Intent-to-treat population is analyzed.||units on a scale||Standard Error|Least Squares Mean
93712|NCT00868192|Secondary|Gene Expression as Assessed by Illumina cDNA Mediated Annealing, Selection, Extension and Ligation (DASL) Microarray From Paraffin-embedded Tumor Specimens With Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.|||||
93713|NCT00868192|Secondary|Frequency of Clinical Response|As measured by RECIST criteria|6 months|||participants|||Number
93655|NCT00868699|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items."|Baseline to Week 6|Intent-to-treat population is analyzed.||units on a scale||Standard Error|Least Squares Mean
93656|NCT00868530|Other Pre-specified|Average Dose of Xyntha Infusions Required Per Hemorrhage|The average dose of Xyntha per hemorrhagic event was calculated as total dose of Xyntha throughout the study (in IU) divided by total number of hemorrhage incidence.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Dose/Bleed (IU)||Standard Deviation|Mean
93657|NCT00868530|Other Pre-specified|Frequency of Xyntha Infusions Required Per Hemorrhage|The mean frequency of Xyntha infusions per hemorrhage was calculated as total number of injections throughout the study divided by total number of hemorrhagic events.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Infusions||Standard Deviation|Mean
93658|NCT00868530|Secondary|Number of Participants With Thrombosis||Baseline up to 6 months|The SS consisted of all participants who had taken at least 1 dose of investigational drug.||Participants|||Number
93659|NCT00868530|Secondary|Number of Participants With Thrombosis Allergic-Type Reactions||Baseline up to 6 months|The Safety Set (SS) consisted of all participants who had taken at least 1 dose of investigational drug.||Participants|||Number
93660|NCT00868530|Secondary|Number of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE, defined for on-demand treatment as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|24 hours after each of 2 successive infusion, up to 6 months|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Participants|||Number
93661|NCT00868530|Secondary|FVIII Recovery : Change From Baseline in FVIII Concentration|FVIII recovery was assessed by evaluating the change in FVIII concentration at 6 months compared to baseline.|Day 1 and Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. Participants with missing data were not included.||IU/dL per IU/kg||Standard Deviation|Mean
93662|NCT00868530|Primary|Number of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and <= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Day 1 and Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Participants|||Number
93663|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|24 hours post infusion|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
93664|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|8 hours post infusion|The Full Analysis Set (FAS) consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
93665|NCT00868517|Secondary|Fragmented Sleep Patterns-Sleep Efficiency|Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months|||percentage of TST to time in bed||95% Confidence Interval|Mean
93666|NCT00868517|Secondary|Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture||t= 2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.||participants|||Number
93667|NCT00868517|Secondary|Attrition Rates|Examined attendance rates in attending group sessions to examine attrition rates.|t=2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.||% of sessions attended||Standard Deviation|Mean
93668|NCT00868517|Secondary|Hypnotic Medication Use|Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).|t=2 months|||participants|||Number
93669|NCT00868517|Secondary|Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps|Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months|||minutes||95% Confidence Interval|Mean
93714|NCT00868192|Secondary|Toxicity Associated With Bevacizumab and Pemetrexed|Detailed serious adverse events and other adverse events are shown in the adverse event module of the results.|6 months|||percentage of participants|||Number
93715|NCT00868192|Secondary|Distribution of Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
93670|NCT00868517|Primary|Perceived Sleep Quality|"Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings.~ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of > 8 is indicative of probable insomnia.~The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality."|t=2 months|||units on a scale||95% Confidence Interval|Mean
93671|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baselin Week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Deviation|Least Squares Mean
93672|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline Week 6|Full analyis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
93673|NCT00868452|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline, Week 6|Full analysis set (intent-to-treat population)||units on a scale||Standard Error|Least Squares Mean
93674|NCT00868439|Secondary|Time to First Elevated Serum K+ > 5.5 mEq/L.||28 Days|||days||95% Confidence Interval|Median
93675|NCT00868439|Secondary|Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L||Baseline and Day 28|Analysis was determined using LOCF.||percentage of participants|||Number
93676|NCT00868439|Secondary|Proportion of Participants Whose Spironolactone Dose Was Increased.||28 Days|||percentage of participants|||Number
93677|NCT00868439|Secondary|Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).|Analysis based on local laboratory data.|28 Days|||percentage of participants|||Number
93678|NCT00868439|Secondary|Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.|Analysis based on central laboratory data.|28 Days|||percentage of participants|||Number
93679|NCT00868439|Primary|Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.||Baseline and Day 28|Analysis was determined using Last Observation Carried Forward (LOCF).||mEq/L||Standard Error|Least Squares Mean
93680|NCT00868374|Primary|Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)|The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.|Week 0 - Week 8|||units on a scale||95% Confidence Interval|Mean
93681|NCT00868348|Secondary|Pain Intensity During Daily Activity|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|16 weeks after surgery|||mm||Inter-Quartile Range|Median
93682|NCT00868348|Secondary|Length of Hospital Stay||From the day of surgery until discharge|||days||Inter-Quartile Range|Median
93683|NCT00868348|Secondary|Home Readiness|Ability to meet discharge criteria (home readiness)|time to fulfilment of discharge criteria|||days||Inter-Quartile Range|Median
93684|NCT00868348|Secondary|Pain Intensity Scores During Walking|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|6-24 hours postoperatively|||mm||Inter-Quartile Range|Median
93685|NCT00868348|Secondary|Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request||within 48 hours after surgery|||min||Inter-Quartile Range|Median
93686|NCT00868348|Primary|Morphine Consumption|Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery|48 hours after surgery|||mg||Inter-Quartile Range|Median
93687|NCT00868309|Secondary|>50,000 Platelets/mm3|Thrombocytopenia during follow up period. Two weeks|Follow up after maintenance dose|||participants|||Number
93688|NCT00868309|Primary|Detection of Plasma Venom Levels During the Post Acute Treatment Period.||Follow up after Maintenance doses were completed. Two Weeks.|||participants|||Number
93689|NCT00868296|Primary|Growth Parameters Z-scores|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|6 weeks|Safety population (all patients with ≥1 dose of study drug) who also had baseline and end of study evaluations. Data point pairs were analyzed. All patients in study 3001B3-335 originated from study 3001B3-331 or -333 and baselines from the original study they were in were used.||units on scale||Standard Deviation|Mean
93716|NCT00868192|Secondary|Distribution of Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)|||months||95% Confidence Interval|Median
93717|NCT00868192|Primary|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|6 months|||percentage of participants||95% Confidence Interval|Number
93718|NCT00868140|Secondary|Matsuda Index|Whole body insulin sensitivity as determined by the Matsuda Index|6 months|||units on a scale||Standard Error|Mean
93690|NCT00868296|Primary|Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period|Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.|6 weeks|Patients who received ≥1 dose of pantoprazole and had laboratory test results. The number of patients (n) tested varied by test, variations shown (low dose, high dose): Carbon dioxide (n=7,26), CPK (n=12,42), Gastrin (n=9,25), Neutrophils (n=12,44), Platelet count (n=12,41), Urine protein albumin (n=10,38), Urine leukocyte esterase (n=10,38).||patients|||Number
93691|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93692|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93693|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93694|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93695|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93696|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93697|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93698|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93699|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93700|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93701|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93702|NCT00868231|Primary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment.||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1||Liters||Standard Error|Least Squares Mean
93703|NCT00868218|Secondary|Immunogenicity of a Non-adjuvanted and 3rd Generation ISCOM™ Adjuvanted Virosomal H5N1 Influenza Vaccine|Number of participants with haemagglutination inhibition tigers >= 32 at the long term time point (1 year post vaccination).|one year|||participants|||Number
93704|NCT00868218|Primary|Adverse Events||42 days|||participants|||Number
93705|NCT00868218|Primary|Solicted Adverse Events|The primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered virosomal H5N1 influenza vaccine with or without 3rd generation ISCOM™ adjuvant.|three months|||participants|||Number
93706|NCT00868192|Post-Hoc|CA-125 Response|A CA-125 response was defined as at least a 50% reduction in CA-125 levels from a pretreatment sample following guidelines described by the Gynecological Cancer Intergroup.|6 months|7 participants were not evauable by CA-125 criteria.||participants|||Number
93707|NCT00868192|Post-Hoc|Overall Response Rate|"Overall response rate = complete response + partial response~Complete response = disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial response = at least a 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be non unequivocal progression of non-target lesions and no new lesions."|6 months|||percentage of participants||95% Confidence Interval|Number
93721|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|6 months|||% bioactivity at time 0 of OGTT||Standard Error|Mean
93722|NCT00868140|Secondary|Matsuda Index|"Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula:~10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load.~Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance."|Baseline|||units on a scale||Standard Error|Mean
93723|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|Baseline|||% bioactivity at time 0 of OGTT||Standard Error|Mean
93724|NCT00868101|Secondary|Troponin I|Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.|24 hours|||pg/mL||Standard Deviation|Mean
93725|NCT00868101|Primary|Interleucine 8|Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method|24 hours|||pg/mL||Standard Deviation|Mean
93726|NCT00868101|Primary|IkB-alpha Expression|"Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in arbitraries units, that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value."|24 hours|||units on a scale||Standard Deviation|Mean
93727|NCT00868101|Secondary|NT-proBNP|Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.|24 hours|||pg/mL||Standard Deviation|Mean
93728|NCT00867659|Primary|Ovarian Volumes as a Predictor of OHSS Severity|ultrasound measurements of both ovaries|30 days|||cc||Full Range|Mean
93729|NCT00867659|Primary|Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS|evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.|4 weeks|||cc (volume of ascites)||Full Range|Mean
93730|NCT00867568|Secondary|AUC of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose||ng*hr/mL||Standard Error|Mean
93731|NCT00867568|Secondary|Cmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose||ng/ml||Standard Error|Mean
93732|NCT00867568|Secondary|Progression Free Survival (PFS) of Participants Using Days From Start of Study Drug Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 4 years|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.||months||Full Range|Mean
93733|NCT00867568|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.||participants|||Number
93734|NCT00867568|Secondary|Tmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose||hour||Full Range|Mean
93735|NCT00867568|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of TPI 287 as a single agent and collect exploratory data on the safety and tolerability of TPI 287 in combination with temozolomide (TMZ) in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma|2 years|||participants|||Number
93736|NCT00867503|Primary|Overall Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.||Life of study|||Days||Full Range|Median
93737|NCT00867503|Secondary|Toxicities of Patients Treated With Bendamustine.|Grade 4 Toxicity|Life of the study|||Partcipants|||Number
93738|NCT00867503|Primary|Progression Free Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria|life of the study|||Days||Full Range|Median
93739|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||Percentage of patients|||Number
93740|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||Percentage of patients|||Number
93741|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||BPM (beats per minute)||95% Confidence Interval|Mean
93742|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||mmHg||95% Confidence Interval|Mean
93743|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||mmHg||95% Confidence Interval|Mean
93744|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.||mmHg||95% Confidence Interval|Mean
93745|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of patients|||Number
93746|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of patients|||Number
93747|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||BPM (beats per minute)||95% Confidence Interval|Mean
93748|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
93749|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
93766|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 2|Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93750|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
93751|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 35|||units on a scale||Standard Deviation|Mean
93752|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 5|||units on a scale||Standard Deviation|Mean
93753|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5|||units on a scale||Standard Deviation|Mean
93754|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5|||units on a scale||Standard Deviation|Mean
93755|NCT00867451|Primary|Percent Total Sleep|Data was gathered via actigraphy. Data on percentage of time individual was immobile during sleep was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly percentage of immobility for that respective week.|Baseline, Week 5|||percentage of immobility||Standard Deviation|Mean
93756|NCT00867451|Primary|Length of Awake Time|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that respective week.|Baseline; Week 5|||minutes||Standard Deviation|Mean
93757|NCT00867451|Primary|Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep)|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) of movement during sleep, for that respective week.|Baseline; Week 5|||minutes||Standard Deviation|Mean
93758|NCT00867451|Primary|Sleep Duration|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.|Baseline; Week 5|||minutes||Standard Deviation|Mean
93759|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 12|Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93760|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 8|Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93761|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 4|Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93762|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 2|Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93763|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 12|Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93764|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 8|Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93765|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 4|Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93816|NCT00867139|Secondary|Number of Participants With Viral Resistance as a Function of Drug Exposure|Viral resistance was assessed within 28 days after drug administration by detecting resistance-conferring mutation genes and compared to the value at baseline.|28 days|One open-labeled patient withdrew on day 5.||Number of participants|||Number
93767|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 12|Plasma campesterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93768|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 8|Plasma campesterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93769|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 4|Plasma campesterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93770|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 2|Plasma campesterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93771|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 12|Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93772|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 8|Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93773|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 4|Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93774|NCT00867165|Secondary|Percent Change From Baseline in Sitosterol at Week 2|Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93775|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12|Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93776|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4|Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93777|NCT00867165|Secondary|Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12|Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93778|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12|Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93779|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8|Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93780|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4|Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93781|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2|Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93782|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 12|Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93783|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 8|Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93784|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 4|Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93785|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 2|Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93786|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12|Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93787|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 8|Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93788|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 4|Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93789|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 2|Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93790|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 8|Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93791|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 4|Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93792|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 2|Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93793|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 8|Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93794|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 4|Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93795|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 2|Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93796|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 8|Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93797|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 4|Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93817|NCT00867139|Secondary|Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1||10 days|Participants assessed for viral shedding were those with available baseline viral load data.||participants|||Number
93798|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 2|Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93799|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 8|Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93800|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 4|Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93801|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 2|Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93802|NCT00867165|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 12|Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage change||95% Confidence Interval|Least Squares Mean
93803|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 12|Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93804|NCT00867165|Secondary|Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percentage Change||95% Confidence Interval|Least Squares Mean
93805|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12|Serum Apo B measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.||Percent Change||95% Confidence Interval|Least Squares Mean
93806|NCT00867165|Secondary|Percentage Change From Baseline in Total Cholesterol (TC) at Week 12|Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study~medication and had a baseline value and at least one valid post-baseline evaluation."||Percentage Change||95% Confidence Interval|Least Squares Mean
93807|NCT00867165|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study~medication and had a baseline value and at least one valid post-baseline evaluation."||Percent Change||95% Confidence Interval|Least Squares Mean
93808|NCT00867139|Secondary|Pharmacokinetics (AUC0-last) of TCAD|Only 5 patients had partial pharmacokinetic (PK) data available. Plasma concentration of oseltamivir was measured at several time points in one patient receiving neuraminidase inhibitor monotherapy. Plasma concentration of oseltamivir, amantadine, and ribavirin were measured at several time points in four patients receiving TCAD therapy. Area under the time-concentration curve up to the last measured time point (AUC0-last) was calculated from the plasma concentration-time profiles by non-compartmental analysis.|5 days|||ng*hr/mL||Standard Deviation|Mean
93809|NCT00867139|Secondary|Number of Deaths||58 days|||participants|||Number
93810|NCT00867139|Secondary|Number of Participants With Intubations||58 days|||participants|||Number
93811|NCT00867139|Secondary|Number of Participants With ICU Admissions|The number of participants with ICU admissions was evaluated.|baseline and up to 58 days|||participants|||Number
93812|NCT00867139|Secondary|Days on Supplemental Oxygen||58 days|One open-labeled TCAD patient withdrew on day 5.||days||Standard Deviation|Mean
93813|NCT00867139|Secondary|Duration of Hospitalization||from baseline up to 58 days|One open-labeled patient withdrew the study on day 5||days||Standard Deviation|Mean
93814|NCT00867139|Secondary|Frequency of Confirmed Pneumonia||58 days|||participants|||Number
93815|NCT00867139|Secondary|Duration of Symptoms|"Calculated as the number of days (mean) any persistent symptom lasted per patient as listed below.~overall health, short of breath, chills, cough, diarrhea, ear pain, fatigue, fever, headache, hoarseness, muscle ache, phlegm, runny nose, sinus congestion, sneezing, sore throat, watery eyes, wheezing"|from baseline up to 28 days|one open labeled patient withdrew on day 5.||days||Standard Deviation|Mean
93839|NCT00866814|Secondary|Procedure Time|Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.|Day of surgery|All enrolled patients.||minutes||Standard Deviation|Mean
93818|NCT00867139|Secondary|Number of Participants With Viral Load Decrease as a Function of Time|Viral loads were measured by quantitative Polymerase Chain Reaction (PCR) on day 1, 3, 5, 7, 9, 15, 20 and 28, if applicable.|baseline and 28 days|Three patients could not get viral load at baseline.||number of participants|||Number
93819|NCT00867139|Primary|Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption|"Abnormal lab data or newly appeared symptoms & signs were considered as AEs.~Examined lab data:~Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)"|30 days after the final dose of study drug|||number of participants with AEs|||Number
93820|NCT00867035|Secondary|Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate||1 week|ITT||percentage black colonies||Standard Deviation|Mean
93821|NCT00867035|Secondary|Number of Bacteria on Tongue at 1 Week|Total viable count(TVC) in colony forming units(CFU) on anaerobe agar|1 week|ITT||colony forming units (CFU)||Standard Deviation|Mean
93822|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT||parts per billion||Standard Deviation|Mean
93823|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT||parts per billion||Standard Deviation|Mean
93824|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours|Using portable gas chromatograph|2 hours|||parts per billion||Standard Deviation|Mean
93825|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour|Using portable gas chromatograph|1 hour|ITT||parts per billion (ppb)||Standard Deviation|Mean
93826|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT||parts per billion (ppb)||Standard Deviation|Mean
93827|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT||parts per billion (ppb)||Standard Deviation|Mean
93828|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours|Using portable gas chromatograph|2hr|ITT||parts per billion (ppb)||Standard Deviation|Mean
93829|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour|Using portable gas chromatograph|1hr|ITT||parts per billion (ppb)||Standard Deviation|Mean
93830|NCT00867035|Primary|Percentage of Participants With Rosenberg Score at Indicated Time Points|2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.|baseline, 1 hour, 2 hours, 4 hours, 1 week|two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.||percentage of participants|||Number
93831|NCT00867009|Secondary|The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.|From start of treatment until documented best tumor response (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.||percentage of participants|||Number
93832|NCT00867009|Secondary|The Percentage of Participants Still Living at One Year (One Year Survival Rate)|The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.|One year|Outcome measure was assessed using the Protocol Qualified (PQ) population.||percentage of participants|||Number
93833|NCT00867009|Secondary|Progression-free Survival (PFS)|PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.|From start of treatment until documented disease progression or death from any cause (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.||months||Full Range|Median
93834|NCT00867009|Primary|Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.|From start of treatment until documented best response. (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.||percentage of participants|||Number
93835|NCT00866905|Secondary|Disease Free Survival|Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.|36 Months||||||
93836|NCT00866905|Secondary|Overall Survival|Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause.|36 months||||||
93837|NCT00866905|Secondary|Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain|Non hematologic treatment-related grade 4 toxicities measured according to RECIST v1.1|3 months|||participants|||Number
93838|NCT00866905|Primary|Pathologic Complete Response Rate (pCR)|Pathologic complete response (pCR) rate will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following neoadjuvant treatment with six (21-day) cycles of ixabepilone and cyclophosphamide|6 months|||participants|||Number
93840|NCT00866814|Secondary|Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey|"Mean Quality of Life scores at each study visit for the sensation of mesh, pain, and movement limitation components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure."|Baseline and post-surgery at week 2, month 6 and month 12|All enrolled patients with QOL scores at each visit.||units on a scale (0-5)||Standard Deviation|Mean
93841|NCT00866814|Secondary|Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|22 days post surgery through 1 year post surgery|All enrolled patients.||Complication events|||Number
93842|NCT00866814|Secondary|Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|Hospital discharge through 21 days post surgery|All enrolled patients.||Complication events|||Number
93843|NCT00866814|Secondary|Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|From the time of surgery to hospital discharge, an average of 1-2 days|All enrolled patients.||Complication events|||Number
93844|NCT00866814|Primary|The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.|A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.|1 year post surgery|All enrolled patients.||participants|||Number
93845|NCT00866788|Secondary|Terminal Half-Life (t1/2) of Omalizumab|Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.||days||Standard Deviation|Mean
93846|NCT00866788|Secondary|Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)|AUCinf is the area under the concentration−time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg*day/mL). Only participants having complete profiles and completed the study were included in the analysis.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.||µg*day/mL||Standard Deviation|Mean
93847|NCT00866788|Secondary|Time to Maximum Concentration (Tmax) of Omalizumab|Tmax is the time to maximum concentration of omalizumab.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.||days||Standard Deviation|Mean
93848|NCT00866788|Secondary|Maximum Observed Concentration (Cmax) of Omalizumab|Cmax is the maximum (or peak) concentration of omalizumab in serum.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population included all randomized participants who received omalizumab and had pharmacokinetic data available. Here, number of participants analyzed = participants with available data for this outcome measure.||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
93849|NCT00866788|Secondary|Number of Participants With Immunogenicity|Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).|16 weeks|Safety-Evaluable Population||participants|||Number
93850|NCT00866788|Secondary|Number of Patients With Adverse Events by Severity|"The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities.~Additional AE data is provided in the AE section below. The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an AE. A “Serious” AE is defined below."|"16 weeks overall (data reported separately for up to 4 weeks and Weeks 5 to 16)"|Safety-Evaluable Population, which included all randomized patients who received any study drug. number (n) equals (=) number of participants analyzed in the specified category.||participants|||Number
93851|NCT00866788|Secondary|Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4|Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||Pills||Standard Deviation|Mean
93902|NCT00866658|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
93852|NCT00866788|Secondary|Change in the Weekly Score for Sleep Interference From Baseline to Week 4|The extent to which hives or itch interfered with participants’ sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
93853|NCT00866788|Secondary|Change in the Weekly Score for Number of Hives From Baseline to Week 4|The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
93854|NCT00866788|Secondary|Change in the Weekly Pruritus Score From Baseline to Week 4|The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
93855|NCT00866788|Primary|Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4|The UAS is a composite diary−recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.||scores on a scale||Standard Deviation|Mean
93856|NCT00866775|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 1 to Week 18, Double-blind: weeks 1 to 18; Baseline: weeks -8 to -1; Titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; Monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60; Baseline: 60; Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Baseline: 118; Titration: 118; AED taper/conversion: 114; Monotherapy: 93||Number of seizures in 28 days||Standard Deviation|Mean
93857|NCT00866775|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population||Percent of participants|||Number
93858|NCT00866775|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|18 Week Double-blind treatment period|ITT population||Percent|||Number
93859|NCT00866775|Secondary|Percentage of Subjects With Increase of Body Weight >= 7%||18 Week Double-blind treatment period|ITT population||Percentage of participants|||Number
93860|NCT00866775|Secondary|Change in Total Score From Baseline in MADRS in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18, Baseline: Day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversation period: 7; Change from baseline to end of monotherapy period: 6 (ESL 1600 mg) Change from baseline to end of AED taper/conversation period: 13; Change from baseline to end of monotherapy period: 13||units on a scale||Standard Deviation|Mean
93861|NCT00866775|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18; Baseline: day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period: 41 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 92; Change from baseline to end of monotherapy period: 91||units on a scale||Standard Deviation|Mean
93862|NCT00866775|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|the numbers analyzed represent all participants for whom data were available at baseline (ESL 1200 mg)Change from baseline to end of AED taper/conversion period: 39;Change from baseline to end of monotherapy period:36 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 86;Change from baseline to end of monotherapy period: 86||units on a scale||Standard Deviation|Mean
93863|NCT00866775|Secondary|Percentage of Subjects Reaching Each of the Exit Events.|The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 1 to Week 18|efficacy population||percentage of participants|||Number
93864|NCT00866775|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population||percentage of participants||95% Confidence Interval|Number
93865|NCT00866775|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60;Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Titration: 118; AED taper/conversion:114; Monotherapy:93||percent change||Inter-Quartile Range|Median
93866|NCT00866775|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|efficacy population||days||95% Confidence Interval|Median
93867|NCT00866775|Secondary|Completion Rate During the 10 Weeks of Monotherapy|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Weeks 8 through 18|efficacy population||percentage of participants||95% Confidence Interval|Number
93868|NCT00866775|Secondary|Completion Rate|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|Week 1 to Week 18|efficacy population||percentage of participants||95% Confidence Interval|Number
93869|NCT00866775|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Weeks 15 through 18|efficacy population||percentage of participants||95% Confidence Interval|Number
93870|NCT00866775|Secondary|Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Weeks 9 through 18|efficacy population||percentage of participants||95% Confidence Interval|Number
93871|NCT00866775|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 3 to Week 18|efficacy population||proportion of participants||95% Confidence Interval|Number
93872|NCT00866723|Primary|Clinical Benefit Response Rate|Clinical benefit response was defined as absence of disease progression at 18 weeks (ie after 6 cycles). Disease progression (PD) could occur per RECIST 1.0 or based on CA-125 levels. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Disease progression based on CA-125 level was doubling of the CA-125 level from baseline. For patients with normal baseline CA-125 (who by definition had MD) the criterion for progression based on CA-125 doubling was doubling of CA-125 from the upper limit of normal (i.e. more than 70).|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.||proportion of particpants||90% Confidence Interval|Number
93913|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|8 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
93873|NCT00866723|Primary|Clinical Response Rate|For measurable disease (MD) patients, clinical response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For non-MD patients, clinical response based on modified Gynecologic Cancer Intergroup (GCIG) criteria was defined as at least a 50% decrease in CA-125 levels.|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
93874|NCT00866697|Secondary|Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)|Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants with any TSH above 5 MU/L were analyzed.||participants|||Number
93875|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.||participants|||Number
93876|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.||participants|||Number
93877|NCT00866697|Secondary|Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population||participants|||Number
93878|NCT00866697|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Adverse Event|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgement was to be exercised in deciding whether reporting was appropriate in other situations, such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population: all randomized participants who received at least one dose of investigational product, based on the actual treatment received if this differed from that to which the participant was randomized||participants|||Number
93879|NCT00866697|Secondary|Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25|The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93930|NCT00866359|Secondary|Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85|Sum of the number oral ulcers, genital ulcers or oral plus genital ulcers at Day 85|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||Ulcers/participants||Standard Error|Least Squares Mean
93880|NCT00866697|Secondary|Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25|The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93881|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25||||||
93882|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25||||||
93883|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93884|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93885|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93931|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85|Area under curve (AUC) from Day 1 to Day 85 (AUC^85) for the number of oral plus genital ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||total AUC (#ulcers*days)||Standard Deviation|Mean
93886|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93887|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93888|NCT00866697|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 (poor to excellent). Participants were asked to respond to the following questions using the 7-item Likert scale: How would you rate your overall health during the past week; How would you rate your overall quality of life during the past week? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA)."|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
93889|NCT00866697|Secondary|3-year Progression-free Survival|3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 3 years after randomization|ITT Population||percentage of participants|||Number
93890|NCT00866697|Secondary|Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria|Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.|From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)|ITT Population. For participants who did not progress or die, progression-free survival was censored at the time of the last adequate disease assessment.||months||95% Confidence Interval|Median
93891|NCT00866697|Secondary|Overall Survival|Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause (median time of follow-up was 24.3 months on pazopanib and 24.2 months on placebo)|ITT Population||months||95% Confidence Interval|Median
93892|NCT00866697|Primary|Investigator-assessed Progression-free Survival (PFS)|PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.|From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
93893|NCT00866658|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
93894|NCT00866658|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
93895|NCT00866658|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
93896|NCT00866658|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
93897|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
93898|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
93899|NCT00866658|Secondary|Change From Screening in Total Insulin Dose at Week 24|Change was calculated by subtracting screening value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Screening, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post baseline insulin dose assessment during on-treatment period.||units per day||Standard Error|Least Squares Mean
93900|NCT00866658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
93901|NCT00866658|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
93903|NCT00866658|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
93904|NCT00866658|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
93905|NCT00866606|Secondary|Percentage of Participants With Red Blood Cell (RBC) Agglutination|RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.||Percentage of Participants|||Number
93906|NCT00866606|Secondary|Percentage of Participants With Thrombosis|Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.||Percentage of Participants|||Number
93907|NCT00866606|Secondary|Percentage of Participants With Allergic-Type Allergic Reactions|Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.||Percentage of Participants|||Number
93908|NCT00866606|Secondary|Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Percentage of Participants|||Number
93909|NCT00866606|Secondary|FIX Incremental Recovery|FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.|Baseline (Visit 2) up to 6 months (Visit 4)|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.||IU/dL per IU/kg||Standard Deviation|Mean
93910|NCT00866606|Secondary|Number of Infusions Required to Treat Each Bleed|The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Infusions||Standard Deviation|Mean
93911|NCT00866606|Primary|Percentage of Participants With FIX Inhibitor Development|Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result >=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and <= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Baseline up to 6 months|Safety Set (SS) population included all enrolled participants who had taken at least 1 dose of drug.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.||Percentage of Participants|||Number
93912|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|24 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.||Units on a scale||Standard Deviation|Mean
93932|NCT00866359|Secondary|Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of genital ulcers per day was not analyzed.|Day 1 to Day 85|No population analyzed due to small number of participants with genital ulcers; not considered meaningful.|||||
97741|NCT00833690|Primary|Safety|Defined as absence of serious adverse experiences (SAEs) that warranted terminating an inosine treatment arm or the trial, as determined by the Data and Safety Monitoring Committee.|24 months|||Events|||Number
93914|NCT00866359|Secondary|Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 197; maximum exposure was 25.1 weeks|Safety analyses for the apremilast-exposure period was based on the apremilast participants as treated (AAT) Population, and included those who were randomized (at the randomization visit) or switched (at the Day 85 visit) to apremilast 30 mg BID, and received at least one dose of apremilast after the initial randomization or switch to 30 mg BID.||particpants|||Number
93915|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase||units on a scale||Standard Deviation|Mean
93916|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 197|Not analyzed due to low numbers of genital ulcers; not considered meaningful.|||||
93917|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response)|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 197|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
93918|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase.||units on a scale||Standard Deviation|Mean
93919|NCT00866359|Secondary|Number of Oral Ulcers at Day 197|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase||ulcers/participants||Standard Deviation|Mean
93920|NCT00866359|Secondary|Number of New Manifestations of Behçet’s Disease or Flare That Were Not Present at Day 1|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:~Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);~Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;~Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;~Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater;~New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||participants|||Number
93921|NCT00866359|Secondary|Behçet's Disease (BD) Current Activity Index Form Score at Day 169|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Deviation|Mean
93967|NCT00866047|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to 17.5 months|Participants with objective response among the intention to treat population||months||95% Confidence Interval|Median
93968|NCT00866047|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
93922|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 169|Not analyzed due to low numbers of genital ulcers; not considered meaningful.|||||
93923|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 169|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline visit. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
93924|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Deviation|Mean
93925|NCT00866359|Secondary|Number of Oral Ulcers at Day 169|The number of oral ulcers were counted at Day 169 in reference to the participants’ first day of active treatment (Day 1 or Day 85).|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||ulcers/participant||Standard Deviation|Mean
93926|NCT00866359|Secondary|Number of New Manifestations of Behçet’s Disease or Flare During the Placebo Controlled Treatment Phase|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:~Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);~Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;~Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;~Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater'~New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 85|Safety population included all participants who were randomized and received at least 1 dose of Investigational Product.||participants|||Number
93927|NCT00866359|Secondary|Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase|A Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase|Safety Population defined as all participants who were randomized and received at least 1 dose of Investigational Product.||participants|||Number
93928|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 85 or to early termination visit|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Error|Least Squares Mean
93929|NCT00866359|Secondary|Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)|Comparison of the percentage of participants who were oral ulcer-free (complete response: free from active oral ulcers), or whose oral ulcers were reduced by ≥ 50%, (partial response) between the apremilast-treated and the placebo-treated groups. In this case, partial response also includes complete response.|Baseline and Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
93998|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
93933|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of oral ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||total AUC (#ulcers*days)||Standard Error|Least Squares Mean
93934|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Baseline to Day 85|Not analyzed due to low numbers of genital ulcers; not considered meaningful.|||||
93935|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Baseline to Day 85|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.||percentage of participants|||Number
93936|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||units on a scale||Standard Error|Least Squares Mean
93937|NCT00866359|Primary|Number of Oral Ulcers at Day 85|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 85|Intent to Treat (ITT) = all randomized participants with at least one oral ulcer evaluation (including the baseline visit). A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.||ulcers/participants||Standard Error|Least Squares Mean
93938|NCT00866320|Secondary|Duration of Overall Response (Tumor Burden Reduction)|Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|followed for overall response for approximately 3 years|Patients who achieved at least 5% tumor reduction||months||95% Confidence Interval|Median
93939|NCT00866320|Secondary|Time to Progression|"Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.~Progression-free survival measured in months and summarized using the Kaplan-Meier method."|followed to progression for approximately 3 years|All patients who started treatment||months||95% Confidence Interval|Median
93940|NCT00866320|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.|followed until progression or death for approximately 3 years|All patients who started treatment||months||95% Confidence Interval|Median
93941|NCT00866320|Primary|Tumor Burden Reduction Rate (TBRR)|The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.|at 8 weeks (2cycles of treatment)|All patients who started treatment||percentage of patients|||Number
93942|NCT00866307|Primary|AALL08P1 Feasibility Outcome|Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)||percentage of participants||90% Confidence Interval|Number
93943|NCT00866307|Primary|AALL08P1 Safety Outcome|Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)||percentage of participants||90% Confidence Interval|Number
93969|NCT00866047|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
93944|NCT00866294|Secondary|Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8|The 7-point CGI-GI assesses the participant's improvement or worsening from baseline. Scores on the CGI-GI range from 1 = very much improved to 7 = very much worse. Responders are defined as participants with a score of 1 or 2 = much improved.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.||percentage of responders|||Number
93945|NCT00866294|Secondary|Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8|The 7-point CGI-SI scale assesses the clinician’s impression of the participant's current illness state. Scores on the CGI-SI range from 1 = not ill at all to 7 = among the most extremely ill. Mean change from baseline was calculated as the value at each time point minus the baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.||scores on a scale||Standard Deviation|Mean
93946|NCT00866294|Secondary|Percentage of HAM-D Remitters at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Remitters are defined as participants with a HAM-D total score of 7 or less.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.||percentage of remitters|||Number
93947|NCT00866294|Secondary|Percentage of HAM-D Responders at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is a sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Responders are defined as participants with a 50 percent or greater reduction from baseline in the HAM-D total score.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.||percentage of responders|||Number
93948|NCT00866294|Secondary|Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at each time point minus the Baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the following datasets: the observed case (OC) dataset for Week 1 and the LOCF dataset for Weeks 2, 3, 4, 6, and 8, where missing values were imputed by the last observed value in the longitudinal data. One participant in the Paroxetine CR group was not included in the OC analysis for having a missing value.||scores on a scale||Standard Deviation|Mean
93949|NCT00866294|Primary|Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8|The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.|Baseline (Week 0) and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase (8 weeks), excluding those who had taken no dose of the investigational product for the treatment phase and who had no data on the HAM-D total score after the start of the treatment phase. The analysis was performed on the last observation carried forward (LOCF) dataset.||scores on a scale||Standard Error|Mean
93950|NCT00866281|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs or SAEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. On treatment death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment) up to End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in safety set population, defined as the participants who received at least one dose of midostaurin.||Participants|||Number
93951|NCT00866281|Secondary|Plasma Concentrations of Midostaurin and Its Metabolites CGP52421 and CGP62221|The plasma concentrations of midostaurin (PKC412) and its two major metabolites, CGP62221 and CGP52421 were determined by using a validated liquid chromatography/tandem mass spectrometry method.|Day 1, Day 5, Day 7, Day 15 (Day 1 of Cycle 2), Day 29 (Day 1 of Cycle 3)|The analysis was performed in pharmacokinetic (PK) set population defined as all safety set participants who had at least one valid (measurable) PK sample of midostaurin, and who had no significant restricted co-medications.||nanograms/milliliters (ng/mL)||Standard Deviation|Mean
93952|NCT00866281|Secondary|Overall Survival With Midostaurin|Overall survival (OS) was defined as the time from start of treatment to date of death due to any cause. The percentage (%) event-free probability estimates were obtained from the Kaplan-Meier survival estimates.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in FAS population.||Months||95% Confidence Interval|Median
97742|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Baseline Visit|||mg/dL||Standard Deviation|Mean
93953|NCT00866281|Secondary|Time to Response With Midostaurin|Time to response was defined as the time from the date of start of midostaurin treatment to the date of first response. The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Time to response was calculated by using the formula = (date of first response -date of start of midostaurin) +1 day.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|"The analysis was performed in FAS population. Here, Number of participants analysed signifies number of responders at specified time points for each arm, respectively."||Days||Full Range|Median
93954|NCT00866281|Secondary|Percentage of Participants With Best Overall Response by Indication|The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Participants with stable disease, progressive disease and with missing tumour assessment or who discontinued the study or who died before having their first assessment were considered as non-responders. Stable disease was defined as failure to achieve any of the above response. Progressive disease was defined as doubling of the bone marrow blast percentage from baseline in participants with <40% bone marrow blasts at baseline, or a 50% increase in bone marrow blast percentage from baseline in participants with >40% bone marrow blasts at baseline,|Baseline, Day 15 (Day 1 of Cycle 2), Day 22 (Day 8 of Cycle 2), Day 29(Day 1 of Cycle 9), End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in full analysis set (FAS) population, defined as all participants to whom study treatment was assigned.||Percentage of Participants|||Number
93955|NCT00866281|Primary|Maximum Tolerated Dose (MTD) of Midostaurin- Posterior Probability of DLT|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT), based on a Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. A DLT was defined as a grade 3 or 4 non-hematological adverse event (AE) or abnormal laboratory value related to study drug. Mean and the 95% posterior probability estimates of having a DLT by age strata and dose is presented. Estimation of MTD and/or recommended dose for expansion (RDE) at the dose-escalation phase of the study was based upon the estimation of the probability of DLT for participants in the dose-determining set (DDS).|Baseline, End of dose escalation phase (6 months)|The analysis was performed in dose determining set (DDS) population. Here, 'n' signifies the number of evaluable participants for this measure.||probability estimates||97.5% Confidence Interval|Mean
93956|NCT00866177|Primary|Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST|Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST|Up to 4 weeks|||participants|||Number
93957|NCT00866047|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||days||Full Range|Median
93958|NCT00866047|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
93959|NCT00866047|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline||percent of participants||95% Confidence Interval|Number
93960|NCT00866047|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
93961|NCT00866047|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
93962|NCT00866047|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
93963|NCT00866047|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment||participants|||Number
93964|NCT00866047|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to 17.5 months|Intention to treat||months||95% Confidence Interval|Median
93965|NCT00866047|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to 17.5 months|Intention to treat||months||95% Confidence Interval|Median
93966|NCT00866047|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to 17.5 months|Participants with complete remission among the intention to treat population||months||95% Confidence Interval|Median
94113|NCT00863356|Primary|Hemostasis Success|Successful hemostasis prior to leaving physician's office|From procedure to hemostasis.|All enrolled subjects||percentage of participants|||Number
93973|NCT00865904|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
93974|NCT00865904|Secondary|Maximum Plasma Concentration (Cmax) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, 24, and 30-60 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
93975|NCT00865904|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Domain Scores at Day 28|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. CFQ-R domains include: Body, Digestion, Eat, Emotion, Health Perceptions, Physical, Respiratory, Role, Social, Treatment Burden, Vitality, and Weight. Individual domain score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||units on a scale||95% Confidence Interval|Least Squares Mean
93976|NCT00865904|Secondary|Change From Baseline in Nasal Potential Difference (NPD) of Zero Chloride Plus Isoproterenol Response at Day 28|"Nasal potential difference (NPD) provides a direct and sensitive evaluation of sodium and chloride transport in secretory epithelial cells via assessment of transepithelial bioelectric properties. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol is reported.~NPDs were performed according to Cystic Fibrosis Foundation Therapeutics Development Network (CFFT TDN) Standard Operating Procedure (SOP) 528.00 “Standardization of Measurement of Nasal Membrane Transepithelial Potential Difference (NPD) – electronic data capture (EDC) and Perfusion or Perfusion-Free Probe”."|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||millivolts (mV)||95% Confidence Interval|Least Squares Mean
93977|NCT00865904|Secondary|Change From Baseline in Sweat Chloride at Day 28|Sweat samples were collected using an approved Macroduct (Wescor) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
93978|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Flow Over the Middle Half of the FVC (FEF25-75) at Day 28|FEF25-75 is total volume of air exhaled from the lungs over the middle half of the FVC test, expressed as liters per second (L/sec).|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||liters per second (L/sec)||Standard Deviation|Mean
93979|NCT00865904|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Day 28|FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||liters||Standard Deviation|Mean
93980|NCT00865904|Secondary|Change From Baseline in Percent Predicted FEV1 at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
93981|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Number of participants analyzed signifies participants evaluable for this outcome.||liters||95% Confidence Interval|Least Squares Mean
93982|NCT00865904|Primary|Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. Serious adverse event (SAE) (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. An AE that started at or after initial dosing of study drug, or increased in severity after initial dosing of study drug visit is considered treatment-emergent.|Up to 14 days after last dose (last dose = Day 28)|Safety set included all participants who received at least 1 dose of study drug.||participants|||Number
93983|NCT00865709|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) was first documented or to the date of death, whichever occurred first according to Response Evaluation Criteria in Solid Tumors (RECIST). Subjects still having CR or PR and alive at the time of analysis were censored at their last date of tumor evaluation. CR was defined as disappearance of tumor lesions, PR as a decrease of at least 30% and PD as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks|Duration of response was the time from the first documented CR or PR until the first documented PD or death (if before progression). Only responders (CR or PR) were included in the analysis||months||95% Confidence Interval|Number
93984|NCT00865709|Secondary|Overall Response|Overall response of a subject was defined as the best tumor response (Complete Response (CR) or Partial Response (PR)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||participants|||Number
94172|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
93985|NCT00865709|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||Months||95% Confidence Interval|Median
93986|NCT00865709|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until 33 months later.|||days||95% Confidence Interval|Median
93987|NCT00865709|Primary|Progression-Free Survival (PFS)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||Months||95% Confidence Interval|Median
93988|NCT00865514|Secondary|Inhibition of Tyrosine and Individual's Haplotype|Given the infusion of the above amino acids and DCA administration the inhibition of tyrosine will be measured in the KRT haplotype and non KRT haplotype.|one week|No statistical analysis. The data was incomplete and was not analyzed.|||||
93989|NCT00865514|Primary|The Interaction of DCA and/or Tyrosine Breakdown Products and Maleylacetoacetate Isomerase (MAAI) in Vivo.|"Subjects are administered an infusion of the amino acids leucine and tyrosine. The next day they start a five day course of dichloroacetate(DCA). At the end of five days they receive another infusion of tyrosine and leucine.~The pharmacokinetics of DCA is calculated following the second infusion."|One week|No statistical analysis. The data was incomplete and was not analyzed.|||||
93990|NCT00865345|Secondary|Device Related Moderate or Device Related Severe Adverse Events|Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy Device related severe adverse event: interrupts a subject’s daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.|days one through six of sensor wear|||events|||Number
93991|NCT00865345|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|61 subjects of 63 enrolled subjects (a total of 4971 paired YSI and sensor readings) completed participation in the inpatient frequent blood sampling procedure.||paired YSI/sensor glucose values|Participants|95% Confidence Interval|Number
93992|NCT00865306|Other Pre-specified|Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up|"Clinicians rated improvement on anxiety since baseline using the Clinical Global Impression-Anxiety Improvement scale (Best 1, Worst 7), with children considered responders if they were rated 1, very much improved or 2, much improved. Note that rates for controls are for controls who were subsequently treated with CBT (after completing the wait-list control condition)."|1-Year Follow-Up|"We tabulated the number of children that were much or very much improved on anxiety since baseline. Note that the controls who were followed up at one-year were those who subsequently received CBT (after participating in the wait-list condition). Therefore the No intervention (wait-list controls) followed up here had actually received CBT."||Participants|||Number
93993|NCT00865306|Other Pre-specified|Number of Children Free of Anxiety Disorders|Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.|Post-Treatment (6-months from baseline)|||Participants|||Number
93994|NCT00865306|Primary|Number of Responders Based on Clinician Global Impression-Anxiety Improvement|"Clinicians blind to treatment assignment rated the child's global improvement on anxiety, using the Clinician Global Impression-Anxiety Improvement scale (CGI-Anxiety, best value 1, worst value 7). Responders were considered those with very much or much improvement (CGI-Anxiety scores of 1 or 2)"|Post-Treatment (6-months from baseline)|||Participants|||Number
93995|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction|Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
93996|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction|Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
93997|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 4 Adverse Event|Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject’s health and well-being, and the ability of the subject to function during the event.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||participants|||Number
93999|NCT00865098|Secondary|Best Response Rate|Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population|best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||percentage of participants||95% Confidence Interval|Number
94000|NCT00865098|Primary|Completion Rate|Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population|time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment||percentage of participants||95% Confidence Interval|Number
94001|NCT00865046|Primary|Pain (WOMAC)|"The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:~Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)"|9 months following baseline|||units on a scale||Standard Error|Mean
94002|NCT00865020|Secondary|Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.~The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.~The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.||mmHg||Standard Error|Least Squares Mean
94003|NCT00865020|Secondary|Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.~The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.~The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.||mmHg||Standard Error|Least Squares Mean
94004|NCT00865020|Secondary|Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.|Baseline, 13 weeks|Full Analysis Set consisting of all participants randomized to treatment with measurements at baseline and day 7 of the withdrawal period.||mmHg||Standard Error|Least Squares Mean
94005|NCT00865020|Secondary|Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.||mmHg||Standard Error|Least Squares Mean
94006|NCT00865020|Primary|Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.||mmHg||Standard Error|Least Squares Mean
94007|NCT00864916|Primary|Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation (% dilation of the brachial artery) at week 48|Measured at Week 48|Numbers of participants who completed the week 48 visit procedures||percent dilation of the brachial artery||Standard Deviation|Mean
94008|NCT00864851|Secondary|Safety Evaluation|Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.|56 Weeks|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal. Analyses were performed on the ITT population because it was identical to the safety population.||participants|||Number
94009|NCT00864851|Secondary|Change From Baseline to Month 12 in Urinary Albumin/Creatinine (A/Cr) Ratio||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||mg/g||Standard Deviation|Mean
94010|NCT00864851|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by an evaluation of change from baseline to Month 12 in eGFR as calculated using the Modification of Diet for Renal Disease (MDRD) equation.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||mL/min/1.73m^2||Standard Deviation|Mean
94011|NCT00864851|Secondary|Change From Baseline to Month 12 in Plasma Globotriaosylceramide (GB3)||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||nmol/ml||Standard Deviation|Mean
94012|NCT00864851|Secondary|Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class|"The NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life.~NYHA Classification - The Stages of Heart Failure:~Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).~Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||participants|||Number
94013|NCT00864851|Secondary|Change From Baseline to Month 12 in the Minnesota Living With Heart Failure Questionnaire (MLHF-Q) Summary Score|Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||scores on a scale||Standard Deviation|Mean
94014|NCT00864851|Secondary|Change From Baseline to Month 12 in Distance Walked in 6-Minute Walk Test (6MWT)|Exercise tolerance using the 6MWT was measured as the total distance walked in 6 minutes.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||m||Standard Deviation|Mean
94015|NCT00864851|Secondary|Change From Baseline to Month 12 in Maximal Oxygen Consumption (VO2 Max) at Peak Exercise|Exercise tolerance as measured by VO2 max at peak exercise using the standard exponential exercise protocol (STEEP).|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||mL/min/kg||Standard Deviation|Mean
94016|NCT00864851|Primary|Change From Baseline to Month 12 in Left Ventricular Mass Indexed to Height (LVMI)|Left ventricular mass (LVM) was measured through echocardiography.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.||g/m^2.7||Standard Deviation|Mean
94017|NCT00864708|Primary|Kinematic Gait Measures|assessment of the lower limb kinematics during ambulation at chosen speed.|Day 1 and at 3 months, following treatment|||percentage of change Day 1 to 3 months|||Number
94018|NCT00864708|Secondary|Manual Muscle Testing (MMT)|This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)|Day 1 and at 3 months, following treatment|||units on a scale|||Number
94019|NCT00864708|Secondary|Stroke Impact Scale (SIS)|The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).|Day 1 and at 3 months, following treatment|||units on a scale|||Number
94020|NCT00864708|Secondary|Ashworth Scale|The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)|Day 1 and at 3 months, following treatment|||units on a scale|||Number
94021|NCT00864708|Secondary|Fugl-Meyer Lower Extremity Score|Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).|Day 1 and at 3 months, following treatment|||units on a scale|||Number
94022|NCT00864708|Primary|Walking Endurance (6MWT)|The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.|Day 1 and at 3 months, following treatment|||feet|||Number
94023|NCT00864682|Secondary|Satisfaction With Anesthetic Technique|Were you satisfied with the anesthetic technique? Yes/No|Prior to discharge. One time assessment|||Participants|||Number
94024|NCT00864682|Secondary|Complete Alleviation of Injection Pain|Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)|Immediately after injection of study drug. One time assessment|||Participants|||Number
94025|NCT00864682|Primary|Verbal Pain Score|11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain|Immediately after injection of study drug. One time assessment.|||Units on a scale||Inter-Quartile Range|Median
94026|NCT00864539|Primary|Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group|Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.|10 weeks|||nmol/L||Standard Deviation|Mean
94027|NCT00864513|Secondary|Number of Participants With Adverse Events|Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0|30 days after last dose of study drug|||participants|||Number
94028|NCT00864513|Secondary|CA 19-9 Response|CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.|Within two months of the last dose of chemotherapy|Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint||participants|||Number
94029|NCT00864513|Secondary|Objective Response|Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0|Within two months of the completion of the last dose of chemotherapy|||participants|||Number
94030|NCT00864513|Primary|Progression-free Survival|Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.|6 months after last patient enrolled|||days||Full Range|Median
94031|NCT00864383|Secondary|Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media.|Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (“isolated positive culture”) was followed by at least two negative culture results.|18 months|||participants with unfavorable outcome|||Number
94032|NCT00864383|Secondary|Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media.|Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (“isolated positive culture”) was followed by at least two negative culture results.|18 months|All randomized subjects.||participants with unfavorable outcome|||Number
94033|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (MGIT Liquid Media)||18 months|All randomized patients excluding late screen failures||Time to culture negative status / weeks||95% Confidence Interval|Median
94034|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (LJ Solid Media)|Culture negative for TB using LJ cultures.|18 months|All randomized patients excluding late screen failures||Time to culture negative status / weeks||95% Confidence Interval|Median
94035|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Liquid MGIT Culture)|Number of patients who are TB MGIT culture negative at 8 weeks.|8 weeks|||participants who are culture negative|||Number
94036|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Solid LJ Culture)|Number of patients who are TB LJ culture negative at 8 weeks.|8 weeks|Per protocol||participants who are culture negative|||Number
94037|NCT00864383|Secondary|Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).|The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.|18 months (within one year of completion of therapy)|Per protocol population||participants with failure or relapse|||Number
94038|NCT00864383|Primary|Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)|The number of participants includes all patients who had at least one grade 3 or 4 adverse event.|18 months (within one year of completion of therapy)|Safety population, defined as all subjects who underwent randomization and who received at least on dose of study drug.||participants with Grade 3 or 4 AEs|||Number
94039|NCT00864383|Primary|Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).|The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.|18 months (within one year of completion of therapy)|Per protocol population||participants with failure or relapse|||Number
94040|NCT00864253|Secondary|Pharmacokinetic Parameters||On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose|Patients randomized to receive ABI-007 treatment in Australia, Canada, Europe, United Kingdom and United States had the option to participate in sparse PK sampling in this study. Only 44 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed|||||
94041|NCT00864253|Secondary|Nadir for the Hemoglobin Count Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included.||g/L||Full Range|Median
97854|NCT00834249|Secondary|AUC0-t - O-desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
94042|NCT00864253|Secondary|Nadir for Platelet Count Measurements.|Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included||10^9/L||Full Range|Median
94043|NCT00864253|Secondary|Nadir for White Blood Cells (WBCs) Measurements|Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included||10^9/L||Full Range|Median
94044|NCT00864253|Secondary|Nadir for the Absolute Neutrophil Count (ANC) Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated Population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included||10^9/L||Full Range|Median
94045|NCT00864253|Secondary|Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum study drug exposure 106 weeks; data cut off 30 June 2012|Treated population||participants|||Number
94046|NCT00864253|Secondary|Summary of Treatment-emergent Adverse Events (AEs)|"A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE’s were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale:~Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012|Treated Population = The Treated population consisted of all randomized participants who received at least one dose of study drug||participants|||Number
94047|NCT00864253|Other Pre-specified|Duration of Response (DOR) in Responding Participants|Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR. DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first. Participants that did not have progression or had not died were censored at the last known time the participant was progression free. Participants that had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #4. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|up to data cut off 30 June 2012|ITT of participants with a confirmed complete or partial overall response||months||95% Confidence Interval|Median
94048|NCT00864253|Other Pre-specified|Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012|ITT||percent of participants|||Number
94049|NCT00864253|Other Pre-specified|Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.|every 8 weeks; up to data cut off 30 June 2012|ITT||percentage of participants|||Number
94050|NCT00864253|Other Pre-specified|Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.|Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months|ITT||months||95% Confidence Interval|Median
94051|NCT00864253|Secondary|Participant Survival|Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.|Up to 38 months; Up to data cut off of 30 June 2012|Intent to treat population||months||95% Confidence Interval|Median
94052|NCT00864253|Primary|Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.|Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012|Intent to treat population = The ITT population consisted of all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments collected.||months||95% Confidence Interval|Median
94053|NCT00864227|Secondary|Platelet Recovery to 50K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >50,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
94054|NCT00864227|Secondary|Incidence of Infections|Number of participants that experienced at least one infection.|Measured at Year 1|||Infections|||Number
94055|NCT00864227|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year|||percentage of participants||95% Confidence Interval|Number
94056|NCT00864227|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval to relapse/ recurrence/progression, to death or to last follow-up.|Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
94057|NCT00864227|Secondary|Chronic GVHD||Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
94058|NCT00864227|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100|||percentage of participants||95% Confidence Interval|Number
94059|NCT00864227|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56|||participants|||Number
94060|NCT00864227|Secondary|Platelet Recovery to 20K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >20,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
94061|NCT00864227|Secondary|Secondary Graft Failure|Secondary graft failure is defined initial recovery followed by neutropenia with < 5% donor chimerism.|Measured at Day 100|||participants|||Number
94062|NCT00864227|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements prior to and day-100.|Measured at Day 100|||participants|||Number
94063|NCT00864227|Secondary|Neutrophil Recovery|Neutrophil recovery is defined as achieving an absolute neutrophil count ≥ 500/mm3 for three consecutive measurements on different days.|Measured at Days 28, 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
94064|NCT00864227|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1|||percentage of participants||95% Confidence Interval|Number
94065|NCT00864123|Secondary|Adverse Symptom Checklist (ASC; Goodman, 2005).|This index assesses adverse side effects that have been associated with DCS, as well as other commonly used psychotropic agents (e.g., SRIs). There are no summary scales for this. Rather, it reflects the presence or absence of 30 potential side effects on a 0-3 scale (0=not at all, 1=slight, 2=moderate, 3=severe) that are associated with study interventions.|Baseline, mid-treatment, post-treatment|Number of participants experiencing an adverse effect related to study interventions. This is a simple frequency count.||participants|||Number
94066|NCT00864123|Secondary|Clinical Global Impression – Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|The CGI-S is a 7-point clinician rating of severity of psychopathology. Ratings range from 1 (“no illness”) to 7 (“extremely severe”). A single rating is chosen for the CGI-S; thus, there are no summary scales/scores.|Baseline, mid-treatment, post-treatment|||units on a scale||Standard Deviation|Mean
94067|NCT00864123|Primary|Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997).|The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. This measure served as the primary outcome index. Scores range from 0-40 with higher scores representing more severe symptoms.|Baseline, Mid-Treatment, Post-treatment|||units on a scale||Standard Deviation|Mean
94068|NCT00864084|Primary|Standing Balance - Critical Point in Distance|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||cm||Standard Deviation|Mean
94069|NCT00864084|Primary|Standing Balance - Critical Point in Time|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||s||Standard Deviation|Mean
94070|NCT00864084|Secondary|Confidence in Disease Management|The COPD Self-Efficacy Scale evaluates level of confidence in ability to manage or avoid breathing difficulty during a range of situations such as feeling frustrated and lifting heavy objects {Wigal, 1991 #3}. Possible answers range from “very confident” (5 points) to “not at all confident” (1 point) and the average score per question is calculated. This scale has been shown to have excellent internal consistency and good test-retest reliability.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||scores on a scale||Standard Deviation|Mean
94071|NCT00864084|Secondary|Fear of Falling|"The Falls Efficacy Scale International (FESI) assesses fear of falling during a range of physical and social activities {Yardley, 2005 #1}. It asks about an individual’s concern about the possibility of following during participation in sixteen common activities, such as cleaning the house, ascending and descending stairs and walking in various environmental conditions. Answers range from 1, “not at all” concerned, to 4, “very concerned, on a 4-point scale, and score is calculated as the average response. This questionnaire has been shown to have excellent internal and test-retest reliability {Yardley, 2005 #1}."|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||scores on a scale||Standard Deviation|Mean
94072|NCT00864084|Secondary|Balance Confidence|Activity-Specific Balance Confidence (ABC) scale measures balance confidence during sixteen activities of progressive difficulty, such as going up and down stairs, reaching for objects and walking in crowded areas {Powell, 1995 #5}. It asks subjects to rate their level of confidence in performing an activity without losing balance on an 11-point scale ranging from 0% (no confidence) to 100% (completely confident). The score is calculated as the average score for each item. This questionnaire has been shown to be sensitive to detect changes in function following rehabilitation {Myers, 1998 #6} and has proven internal consistency and test-retest reliability {Powell, 1995 #5}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||units on a scale||Standard Deviation|Mean
94073|NCT00864084|Primary|Dynamic Balance|Dynamic balance was measured using the timed up and go (TUG) and Four Square Step Test (FSST). For the TUG, the time taken for the subject to stand from a chair, walk 3 m, turn around and return to the chair was recorded {Podsiadlo, 1991 #31}. Subjects were asked to do this as quickly and safely as possible. High test-retest reliability of the TUG has been reported in older community-dwelling individuals {Steffen, 2002 #34}. In the FSST, subjects were asked to step to four corners of a square in a clockwise and then counter-clockwise direction as quickly as possible {Dite, 2002 #1181}. The time taken to complete this circuit was recorded. This test has been shown to have high inter-rater and test-retest reliability {Dite, 2002 #1181}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||seconds||Standard Deviation|Mean
94074|NCT00864084|Primary|Standing Balance - Sway Path|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks|||cm/s||Standard Deviation|Mean
94075|NCT00864032|Primary|Number of Dose Limiting Toxicities|"Number of dose limiting toxicities and number with adverse events.~Dose-escalation schedule comprising 6 to 12 patients (see schema). This sample size is based on a traditional 3+3 cohort design with escalating doses of sorafenib in combination with 50 Gy of conformal radiotherapy delivered in 25 fractions (200 cGy per fraction). Based on preclinical data regarding the radiobiology of sorafenib,33, 36 sorafenib will be initiated at a dose of 200 mg twice daily, followed by 200 mg Q AM/400 mg Q PM for the 2nd cohort, followed by 400 mg bid for the 3rd cohort. Since 400 mg bid is the well established MTD for sorafenib monotherapy in patients with renal cell carcinoma and hepatocellular carcinoma, the dose will not be escalated above this level even if DLT is not observed. Dose level escalation will be determined based on DLTs observed from initiation of sorafenib/RT until time of surgery."|Approximately 12 weeks|||DLTs|||Number
94076|NCT00863798|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS)|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms.|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
94077|NCT00863798|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of “Yes” on “Actual Attempt”),preparatory acts toward imminent suicidal behavior (3)(“Yes” on “Preparatory Acts or Behavior”),suicidal ideation (4)(“Yes” on “Wish to be dead”,“Non-Specific Active Suicidal Thoughts”,“Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(“Yes” on “Has subject engaged in Non-suicidal Self-Injurious Behavior”).|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Participants|||Number
94078|NCT00863798|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Percentage of Participants|||Number
94114|NCT00863356|Secondary|This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material.||Removal: 48 hours. Follow-up: 1 week.||||||
97892|NCT00833937|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
94079|NCT00863798|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
94080|NCT00863798|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Error|Mean
94081|NCT00863798|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.||nanogram(ng)/mL||Standard Deviation|Mean
94082|NCT00863798|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
94083|NCT00863798|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
94084|NCT00863798|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
94085|NCT00863798|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
94086|NCT00863798|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
94087|NCT00863798|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
94088|NCT00863798|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
94089|NCT00863798|Secondary|Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
94090|NCT00863798|Primary|Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.||Units on a scale||Standard Error|Mean
94091|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score|A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement)|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
94092|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score|The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
94093|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
94094|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
94095|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status|The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set||Scores on a scale||Standard Deviation|Mean
94096|NCT00863746|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier).|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
94097|NCT00863746|Secondary|Objective Tumor Response|Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Proportion of participants|||Number
94098|NCT00863746|Secondary|Disease Control|Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)].|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Proportion of participants|||Number
94099|NCT00863746|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
94100|NCT00863746|Primary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.|From randomization of the first subject until 36 months later|Full Analysis Set (FAS)||Days||95% Confidence Interval|Median
94101|NCT00863707|Primary|Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)|"The data represents the numbers of subjects reporting Serious TEAEs.~TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug."|24 hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.||Subjects|||Number
94102|NCT00863655|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the proportion of patients whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST.|Every 6 weeks||12/2015||||
94103|NCT00863655|Secondary|Qol Scores ECOG Performance Status|Change in QoL scores over time and time to deterioration of ECOG performance status.|Every 6 weeks||12/2015||||
94104|NCT00863655|Secondary|Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)|In addition to AEs/SAEs, shift from baseline in vital signs and laboratory results (hematology, blood chemistry) will be reported.|Continuous and every 6 weeks||12/2015||||
94105|NCT00863655|Secondary|Overall Response Rate (ORR)|ORR is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST.|Every 6 weeks||12/2015||||
94106|NCT00863655|Secondary|Overall Survival (OS)|Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause.|Every 3 months after End of Treatment + 28 days (every 6 weeks before)||12/2015||||
94107|NCT00863655|Primary|Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.|Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.0). For patients with no target lesion, in the absence of new lesions, the overall lesion response at each assessment was one of following: Complete Response CR), Stable Disease SD), Unknown, or Progressive Disease (PD) based on non-target lesion responses. The following is considered progression among patients with lytic or mixed (lytic+sclerotic) bone lesions: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.|date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first ,reported between day of first patient randomized, 27 July 2009, until cut-off date 11 February 2011.|All randomized patients were included in the Full Analysis Set.||months||95% Confidence Interval|Median
94108|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient’s recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.||Percentage of Subjects|||Number
94109|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.||Percentage of Subjects|||Number
94110|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient’s recent memory. The total score ranges from 0 (no memory) to 12 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.||Percentage of Subjects|||Number
94111|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.||Percentage of Subjects|||Number
94112|NCT00863551|Primary|Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5|Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.|Day 10, Hour 5|Intent-to-treat, which included all patients who started the study.||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
94116|NCT00863343|Primary|MSD Influenza B Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day|||participants|||Number
94117|NCT00863343|Primary|MSD Influenza A Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day|||participants|||Number
94118|NCT00863343|Primary|MSD Influenza B Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day|||participants|||Number
94119|NCT00863343|Primary|MSD Influenza A Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.|1 day|per protocol||participants|||Number
94120|NCT00863330|Primary|Primary Objective|Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.|4-6 weeks after completion of TIL|Study was terminated for administrative reasons. complete data was not collected and no data analysis was completed|||||
94121|NCT00863317|Primary|Duration of Cough||up to 4 weeks|||days||Inter-Quartile Range|Median
94122|NCT00863109|Secondary|Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)|Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants; participants who had met the evaluation and eligibility criteria and were included in the study. Analysis Population included 53 participants who completed 48 weeks of treatment and 77 participants who did not complete 48 weeks of treatment (early end).||percentage of participants|||Number
94123|NCT00863109|Secondary|MCID in CLDQ-HCV Scores|The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.||score on a scale||Standard Deviation|Mean
94124|NCT00863109|Secondary|Minimal Clinically Important Difference (MCID) in SF-36 Scores|SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.||score on a scale||Standard Deviation|Mean
94125|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).||score on a scale||Standard Deviation|Mean
94137|NCT00863057|Secondary|Pain-related Interference Measured by the Brief Pain Inventory (BPI) Interference Items|"The BPI interference scale measured level of interference with the following seven items:~General activity~Mood~Walking ability~Normal work~Relations with other people~Sleep~Enjoyment of life~Interference scales range from 0=’Does not interfere’ to 10=’Completely interferes’. The overall BPI score is the mean of seven item with the minimum and maximal scores of 0 and 70, respectively."|At the fourth week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Inter-Quartile Range|Median
97917|NCT00833859|Secondary|Number of Participants With Overall Survival|We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.|6 months per patient||||||
94126|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).||score on a scale||Standard Deviation|Mean
94127|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)|The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72.||score on a scale||Standard Deviation|Mean
94128|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72.||score on a scale||Standard Deviation|Mean
94129|NCT00863057|Other Pre-specified|Methadone Trough Level and Weekly Mean Pain Scores|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint.|During the fourth week of each treatment period||||||
94130|NCT00863057|Other Pre-specified|Sensory and Affective Qualities of Pain Measured by the McGill Pain Questionnaire - Short Form (MPQ-SF)|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint in the future.|At the fourth treatment week of each treatment period||||||
94131|NCT00863057|Secondary|Incidence of Treatment-emergent Grade 3 to 4 (Safety) and Grade 2 (Tolerability) Toxicities|Grade 2, 3, and 4 events are listed in the AE section.|Throughout study||||||
94132|NCT00863057|Secondary|Maximum Tolerated Dose of Duloxetine and Methadone||During each treatment period|The number below is the highest tolerated daily dose in mg based on n=12 for Methadone and n=10 for Duloxetine.||mg|||Number
94133|NCT00863057|Secondary|Use of Rescue Medication (Acetaminophen)||During each treatment period and the subsequent cross-over (or final study week) period|The analysis was per protocol. Because of a cross-over trial, the # of participants analyzed do not match with the flow chart. Any participant who took the rescue med during the study period (incl. cross-over period) was counted in this analysis. If a participant took the rescue med twice within the same period, the number is counted as one.||participants|||Number
94134|NCT00863057|Secondary|Patient and Clinician Global Impression of Change (PGIC and CGIC) on a 7-point Likert Scale|"The GIC scale is a validated instrument that consists of seven verbal descriptors on a 7-point scale:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse~Participants were carefully instructed to consider the impact of study treatments on their level of neuropathic pain intensity during the baseline phase of the study."|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||participants|||Number
94135|NCT00863057|Secondary|Emotional Functioning as Measured by the Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item: (0) Rarely, (1) Occasionally, (2) Sometimes, and (3) Most of time. Some items are multiplied by -1 to change direction. The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered.|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Standard Deviation|Mean
94136|NCT00863057|Secondary|Quality of Life Measured by SF-36 Healthy Survey (SF-36)|This endpoint was not analyzed as there was an issue with a company which provides a software to calculate SF-36. We do not have any plan to analyze this endpoint in the future.|At the fourth treatment week of each treatment period||||||
94168|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
94138|NCT00863057|Secondary|Mean Nighttime Pain Measure on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average during the night time."|Over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Standard Error|Mean
94139|NCT00863057|Secondary|Number of Participants With 50% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||participants|||Number
94140|NCT00863057|Secondary|Number of Participants With 30% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||participants|||Number
94141|NCT00863057|Primary|Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average over the past 24 hours."|During the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.||Scores on a scale||Standard Deviation|Mean
94142|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. MMSE: Brief, structured examination of mental status that assesses orientation, memory, attention, naming, comprehension, and praxis. The range is 0 to 30, with a lower score indicating a worse mental state|Baseline to 1 year|FAS, OC||Scale scores||Standard Error|Least Squares Mean
94143|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. COWAT: Verbal fluency test. The patient was asked to, during 1 minute, generate as many words as possible beginning with three pre-specified letters. The total score was calculated as the sum of acceptable words generated, with higher scores indicating lower cognitive impairment|Baseline to 1 year|FAS, observed cases (OC)||Scale scores||Standard Error|Least Squares Mean
94144|NCT00862940|Secondary|Changes in Total Hippocampal Volume (HCV)|Estimated mean changes in total HCV|Baseline to 1 year|FAS-MRI||mm^3/year||Standard Deviation|Mean
94145|NCT00862940|Primary|Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)|Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52)|Baseline to 1 year|FAS-MRI: Full-analysis set for all patients in the all-patients-treated set (APTS) who had at least one valid MRI scan >=6 months after initiation of investigational medicinal product (IMP). The FAS (full analysis set, efficacy set) replaces the intention-to-treat (ITT) concept used in older terminology.||mL/year||Standard Error|Mean
94146|NCT00862849|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) Related to Study Drug|The number of TEAEs related to study drug (as determined by the Investigator) are summarized. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|first dose through 7 to 10 days after last dose|Participants who received at least one dose of study drug (insulin lispro, regular human insulin, or recombinant human hyaluronidase [rHuPH20]).||events|||Number
94147|NCT00862849|Secondary|Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and every 30 mins (from 90 to 240 mins) after each injection. Percentage of total glucose infused from 0 to 4 hours is summarized.|predose up to 240 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.||percentage of total glucose infused||Standard Deviation|Mean
94148|NCT00862849|Secondary|Time to Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. Time to 25%, 50%, and 75% of total glucose infused are summarized.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.||minutes||Standard Deviation|Mean
94149|NCT00862849|Secondary|Peak Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable Cmax data.||picomoles per liter (pmol/L)||Standard Deviation|Mean
94150|NCT00862849|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable t(50%max) data.||minutes||Standard Deviation|Mean
94151|NCT00862849|Primary|Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.|predose up to 30 minutes postdose|Participants who completed all study visits and had evaluable %AUC(0-t) data.||percentage of coefficient of variance||Standard Deviation|Mean
94152|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.|Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
94153|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.|Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
94154|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.|Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
94155|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.|Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
94156|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.|Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
94157|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).|Median overall survival (OS)|From date of registration (Informed Consent Form completed) until the date of death.|||Months||95% Confidence Interval|Median
94158|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).|Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.|From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.|||Months||95% Confidence Interval|Median
94159|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).|Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.|||Participants|||Number
94160|NCT00862823|Primary|Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz|The maximum concentration for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.||mg/L||Geometric Coefficient of Variation|Geometric Mean
94161|NCT00862823|Primary|Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz|The area under the concentration time curve for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
94162|NCT00862810|Primary|Pain Following HPV Vaccine|"Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.~The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain."|10 minutes following vaccination|||participants|||Number
94163|NCT00862784|Secondary|Serum Anti-IMC-1121B (Immunogenicity) at Day 1|Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies.|Day 1 (Cycles 1, 5, 9, and 30-day follow-up)|All participants who received any amount of study drug and had serum Anti-IMC-1121B (ramucirumab) evaluated.||participants|||Number
94164|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
94165|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
94166|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
94167|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
94173|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.|||||
94174|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)|Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received any amount of study drug.||participants|||Number
94175|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)|Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received at any amount of study drug.||participants|||Number
94176|NCT00862784|Secondary|Duration of Response|The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.|Time of response to time of measured progressive disease up to 22.2 months|All participants who received any amount of study drug who had CR and PR.||months||95% Confidence Interval|Median
94177|NCT00862784|Secondary|Overall Survival (OS)|OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 18.||months||95% Confidence Interval|Median
94178|NCT00862784|Secondary|Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]|ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease up to 23.8 months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
94179|NCT00862784|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 11.||months||95% Confidence Interval|Median
94180|NCT00862745|Primary|Change in Frequency of Urge Urinary Incontinence Episodes at Week 12.||Baseline and Week 12|The population analyzed included all participants receiving at least 1 dose of study intervention.||episodes||Standard Deviation|Mean
94181|NCT00862719|Secondary|Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity|Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.|Transplant (Day 0) up to 3 years|All patients enrolled and received treatment.||participants|||Number
94182|NCT00862719|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment who achieved platelet recovery/engraftment of platelets.||days||95% Confidence Interval|Median
94183|NCT00862719|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment.||days||95% Confidence Interval|Median
94184|NCT00862719|Primary|Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant|Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.|Transplant (Day 0) through Day +30|Modified Intent to treat population (mITT) - all patients receiving at least one dose of study drug and receiving REB depleted UCB units only||percentage of participants||95% Confidence Interval|Number
94185|NCT00862654|Primary|Total Severity Score (TSS): Percent Change From Baseline at Week 4|Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.|baseline and week 4|Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)||Percent change||Full Range|Median
94186|NCT00862641|Secondary|Percentage of Selected Respiratory Adverse Events|"The selected respiratory Adverse Events are dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea and wheezing.~Subjects may have reported more than one type of Adverse Event."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Percentage of Subjects|||Number
94187|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry|Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.||Percentage of Oxygen Saturation||Standard Deviation|Mean
94188|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio|"FEV1 and FVC data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|"The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as N."||Percentage of FEV1 / FVC||Standard Deviation|Mean
94189|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)|"FVC data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.||Liters||Standard Deviation|Mean
94190|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted|"FEV1 data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.||Percentage of Predicted FEV1||Standard Deviation|Mean
94191|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values|"FEV1 data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each time point is noted in the category titles, as “N”.||Liters||Standard Deviation|Mean
94192|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).~Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.~The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Subjects|||Number
94193|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).~Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.~The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 2 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Subjects|||Number
94194|NCT00862641|Primary|Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment|FEV1 data was obtained by spirometry measures.|2 Hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.||Percentage of Subjects|||Number
94195|NCT00862563|Secondary|Wechsler Memory Scale-3rd Ed. Spatial Span|WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||units on a scale||Standard Error|Mean
94196|NCT00862563|Secondary|Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total|WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||units on a scale||Standard Error|Mean
94197|NCT00862563|Secondary|COWAT-Category|Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced.|Baseline, Week12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||Number of Words Produced||Standard Error|Mean
94212|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) – Independent Radiologist|The independent radiologist determined the PF for each lesion|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||seconds||Standard Deviation|Mean
94198|NCT00862563|Secondary|Controlled Word Association Test (COWAT)- Letter Fluency|Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown.|Baseline & Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.||Number of Words Produced||Standard Error|Mean
94199|NCT00862563|Secondary|Percent Days Drinking|Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.||Percentage of Days/ Week||Standard Error|Mean
94200|NCT00862563|Secondary|Mean Percent Days Heavy Drinking|Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the time frame for the specific analyses, i.e. Weeks 10,11,12.||Percentage of Days/Week||Standard Error|Mean
94201|NCT00862563|Secondary|AB-Neurotoxicity Scale.|Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|Week 12|Alcohol dependent subjects.||Scale Scores||Standard Error|Mean
94202|NCT00862563|Primary|The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties.|Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.||Standard Drinks per day||Standard Error|Mean
94203|NCT00862537|Primary|Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months|The Parkinson’s Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson’s Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).|baseline and 11 months|||scores on a scale||Standard Deviation|Mean
94204|NCT00862459|Secondary|Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter|CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding subjects who had no lesion detected, and those who had no value determined)||CNR||Standard Deviation|Mean
94205|NCT00862459|Secondary|Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group|The blinded readers gave an estimation of the tumor grade of brain tumors (low grade [I or II] or high grade [III or IV]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results|up to 2 hours after the injection of study medication|PPS participants with tumors||Percentage of accuracy|||Number
94206|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94207|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94208|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94209|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94210|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94211|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94213|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) – Independent Radiologist|The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||seconds||Standard Deviation|Mean
94214|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) – Independent Radiologist|The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||seconds||Standard Deviation|Mean
94215|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) – Independent Radiologist|The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||mL / 100 g tissue / min.||Standard Deviation|Mean
94216|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) – Independent Radiologist|The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||mL / 100 g tissue||Standard Deviation|Mean
94217|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) – Independent Radiologist|The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)||mL / 100 g tissue||Standard Deviation|Mean
94218|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94219|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94220|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94221|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94222|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94223|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94224|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS||percentage of participants|||Number
94225|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94226|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94227|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94228|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94229|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94230|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94231|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94232|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94233|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94234|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94235|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94236|NCT00862459|Secondary|Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI|The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.||percentage of participants|||Number
94237|NCT00862459|Secondary|Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI|The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.|up to 2 hours after the injection of study medication|PPS||percentage of exact matches|||Number
94238|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS(excluding subjects with no enhanced lesion detected)||percentage of lesions|||Number
94239|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)||percentage of lesions|||Number
94240|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)||percentage of lesions|||Number
94241|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||percentage of lesions|||Number
94242|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||percentage of lesions|||Number
94243|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||percentage of lesions|||Number
94244|NCT00862459|Primary|Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI|CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding participants with insufficient images)||CNR||Standard Deviation|Mean
94245|NCT00862459|Primary|Assessment of Internal Morphology|The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||scores on a scale||Standard Deviation|Mean
94246|NCT00862459|Primary|Assessment of Border Delineation|The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||scores on a scale||Standard Deviation|Mean
94247|NCT00862459|Primary|Assessment of Lesion Contrast Enhancement|The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)||scores on a scale||Standard Deviation|Mean
94282|NCT00862082|Secondary|Pharmacokinetics (Cmax) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng/ml||Standard Deviation|Mean
94248|NCT00862459|Primary|Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.|Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.|up to 2 hours after the injection of study medication|PPS (excluding one participant with insufficient images)||Lesions per participant||Standard Deviation|Mean
94249|NCT00862459|Primary|Categorical Visualization Score (CVS)|The primary visualization variables (number [no.] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)–(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.|up to 2 hours after the injection of study medication|The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)||Scores on a scale||Standard Deviation|Mean
94250|NCT00862277|Primary|Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
94251|NCT00862277|Primary|Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Percentage of Participants|||Number
94252|NCT00862251|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94253|NCT00862251|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94254|NCT00862251|Secondary|Percent Change From Baseline Apolipoprotein A-I (Apo A-I)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94255|NCT00862251|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94256|NCT00862251|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
94257|NCT00862251|Secondary|Percent Change From Baseline in TC/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94258|NCT00862251|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94259|NCT00862251|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94260|NCT00862251|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||percent change||95% Confidence Interval|Least Squares Mean
94261|NCT00862251|Secondary|Percent Change From Baseline in Triglycerides||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94262|NCT00862251|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent Change||95% Confidence Interval|Least Squares Mean
94263|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg||participants|||Number
94264|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg||participants|||Number
94265|NCT00862251|Secondary|Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||participants|||Number
94266|NCT00862251|Secondary|Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin||Baseline and Week 6|Efficacy data were analyzed primarily based upon the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94267|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg||Percent change||95% Confidence Interval|Least Squares Mean
94268|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg||Percent change||95% Confidence Interval|Least Squares Mean
94269|NCT00862251|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.||Percent change||95% Confidence Interval|Least Squares Mean
94270|NCT00862186|Primary|Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness.|The FS-A is a 14-item self-report instrument which measures on a 5 point scale ranging from ‘1 - not at all’ to ‘5 - all the time’ the extent to which each of 14 statements describes how the respondent has been feeling during the past 7 days (Hinds et al., 2007). The potential score range is 14-70; higher scores represent greater fatigue (Hinds et al., 2007). The scores (1 through 5) on the Likert-type scales for resource use and resource helpfulness were determined at each post baseline time point, as were change from baseline values for the FS-A. All FS-A change from baseline values, per Resource Use or Resource Helpfulness Categorization, were combined regardless of post-baseline time point.|baseline and weekly up to 8 weeks|||units on a scale||Full Range|Median
94271|NCT00862134|Secondary|Positive Aldo-keto Reductase 1C3 (AKR1C3) Expression in Participating Patients|"AKR1C3 was evaluated on a semi-quantitative scale, and the percentage of cells staining at each of the following four levels was recorded: 0 (unstained), 1+ (weak staining), 2+ (moderate staining) and 3+ (strong staining).~Patients with a strong staining score (3+) were considered to be AKR1C3 positive"|Within 1 year of enrollment|||participants|||Number
94272|NCT00862134|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following last administration of study treatment|||participants|||Number
94273|NCT00862134|Primary|Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone|Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria|Participants were followed for the duration on study, an average of 4 months|||participants|||Number
94274|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance|A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.|At Week 10, end of treatment|Safety Analysis Set (OC). Descriptive statistics only.||mL/min||Standard Deviation|Mean
94275|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)|The WPAI_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.||WPAI_CD Item 5 score||Standard Deviation|Mean
94276|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score|The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL).|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.||IBDQ score||Standard Deviation|Mean
94277|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)|Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.||mg/L||Standard Deviation|Mean
94278|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Fecal Calprotectin|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.|At Week 10, end of treatment|Full Analysis Set (FAS), observed cases (OC), descriptive statistics only.||microgram/gram faeces||Standard Deviation|Mean
94279|NCT00862121|Primary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.|The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70.|At Week 10, end of treatment|The percentage of CDAI responders at Week 10 was analysed for the FAS (treated participants with post-baseline CDAI), Last Observation Carried Forward (LOCF).||percentage of participants|||Number
94280|NCT00862082|Secondary|Pharmacokinetics (AUC) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng.h/ml||Standard Deviation|Mean
94281|NCT00862082|Secondary|Pharmacokinetics (T1/2) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||hr||Standard Deviation|Mean
94283|NCT00862082|Secondary|Pharmacokinetics [Area Under the Curve(AUC)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng.h/ml||Standard Deviation|Mean
94284|NCT00862082|Secondary|Pharmacokinetics [Half Life (T1/2)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.||hr||Standard Deviation|Mean
94285|NCT00862082|Secondary|Pharmacokinetics [Maximum Plasma Concentration (Cmax)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in pharmacokinetic (PK) sampling was optional to subjects, therefore not all subjects in the study were analyzed.||ng/ml||Standard Deviation|Mean
94286|NCT00862082|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment|||participants|||Number
94287|NCT00862082|Primary|Maximum Tolerated Dose (MTD) of PR104 When Used in Combination With Standard Dose Sorafenib in the Phase I Population||4 weeks (1 cycle)|||mg/m2|||Number
94288|NCT00861913|Secondary|Duration of Response|The date at which the objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented, assessed up to 5 years.|From time of documented response to the date progression is documented, assessed up to 5 years.|There was one response and therefore median duration of response was not analyzed.|||||
94289|NCT00861913|Secondary|Progression Free Survival|Progression free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 5 years|||months||95% Confidence Interval|Median
94290|NCT00861913|Secondary|Overall Survival|Overall survival time is defined as the time from registration to the time of death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|||months||95% Confidence Interval|Median
94291|NCT00861913|Primary|Toxicity|Toxicity is defined as any grade 3 or higher adverse event as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and at least possibly related to treatment. The maximum grade for each type of toxicity will be recorded for each patient. We report the number of patients experiencing a grade 3 or higher adverse event at least possibly related to treatment.|Up to 5 years|||participants|||Number
94292|NCT00861913|Primary|Tumor Response Rate|"Tumor response rate is defined as the number of eligible patients whose disease status meets the Response Evaluation Criteria In Solid Tumors (RECIST) criteria for compete response (CR) or partial response (PR) divided by the number of evaluable patients. A ninety percent confidence interval for the true response proportion will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution and using the Duffy-Santner approach.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 5 years|||percentage of patients||90% Confidence Interval|Number
94293|NCT00861757|Secondary|Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||beats per minute (bpm)||Standard Deviation|Mean
94294|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Standing) at 12 Weeks||baseline, 12 weeks|All efficacy analyses were performed on an intent-to-treat (ITT) basis. The primary analysis population for efficacy was the Full Analysis Set (FAS) which included all subjects who were randomized and started study medication.||mm Hg||Standard Deviation|Mean
94295|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Sitting) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||mm Hg||Standard Deviation|Mean
94296|NCT00861757|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||milliliter (mL)||Standard Deviation|Mean
94297|NCT00861757|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks|Nanograms of PSA per milliliter (ng/mL) of blood.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||microgram/Liter||Standard Deviation|Mean
94298|NCT00861757|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12|The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||participants|||Number
94299|NCT00861757|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12|The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||Participants|||Number
94349|NCT00861705|Secondary|Time to First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause|From study entry to first event.|up to 10 years||10/2018||||
94300|NCT00861757|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks|"Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||milliliter per second (mL/sec)||Standard Error|Least Squares Mean
94301|NCT00861757|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||units on a scale||Standard Error|Least Squares Mean
94302|NCT00861757|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks|"Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||units on a scale||Standard Error|Least Squares Mean
94303|NCT00861757|Secondary|Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||units on a scale||Standard Error|Least Squares Mean
94304|NCT00861757|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|"The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.~Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.||Units on a scale||Standard Error|Least Squares Mean
94305|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94306|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (PPD ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||EU/mL||95% Confidence Interval|Geometric Mean
94307|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94308|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||EU/mL||95% Confidence Interval|Geometric Mean
94309|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94463|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 2|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 2|FAS (LOCF)||participants|||Number
94310|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody concentrations are expressed as Geometric Mean Titer (GMT).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Titer||95% Confidence Interval|Geometric Mean
94311|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94312|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody titers were expressed as Geometric Mean Titer (GMT).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Titer||95% Confidence Interval|Geometric Mean
94313|NCT00861744|Secondary|Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.||From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
94314|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.|From Day 180 to Day 730 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
94315|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
94316|NCT00861744|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).|NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
94317|NCT00861744|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 15-day (Days 0-14) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
94318|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.|Swelling with accompanying general symptoms|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
94319|NCT00861744|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
94320|NCT00861744|Secondary|Number of Subjects Reporting Medically Attended Visit (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.||Subjects|||Number
94321|NCT00861744|Secondary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
94322|NCT00861744|Secondary|Number of Subjects Reporting Fever.|fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.|During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
94323|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||IU/mL||95% Confidence Interval|Geometric Mean
94324|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||IU/mL||95% Confidence Interval|Geometric Mean
94325|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94326|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94327|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94328|NCT00861744|Secondary|Number of Subjects Reporting Other Rash.|Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
94329|NCT00861744|Secondary|Number of Subjects Reporting Febrile Convulsions|Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
94330|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))|Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Titers||95% Confidence Interval|Geometric Mean
94331|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.||During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.||Subjects|||Number
94332|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||mIU/mL||95% Confidence Interval|Geometric Mean
94333|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||mIU/mL||95% Confidence Interval|Geometric Mean
94334|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94379|NCT00861614|Primary|Overall Survival (OS)|OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.|Date of randomization to date of death|All randomized participants||months||95% Confidence Interval|Median
94335|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.||Subjects|||Number
94336|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 0 before vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||µg/mL||95% Confidence Interval|Geometric Mean
94337|NCT00861744|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
94338|NCT00861744|Secondary|Anti-hepatitis A Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||mIU/mL||95% Confidence Interval|Geometric Mean
94339|NCT00861744|Secondary|Anti-varicella Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||mIU/mL||95% Confidence Interval|Geometric Mean
94340|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 42 after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||µg/mL||95% Confidence Interval|Geometric Mean
94341|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||IU/mL||95% Confidence Interval|Geometric Mean
94342|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Titers||95% Confidence Interval|Geometric Mean
94343|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||mIU/mL||95% Confidence Interval|Geometric Mean
94344|NCT00861744|Secondary|Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.|Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
94345|NCT00861744|Primary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
94346|NCT00861744|Primary|Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
94347|NCT00861744|Primary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.||Subjects|||Number
94348|NCT00861705|Secondary|Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.|Assessed by physician observation.|at definitive surgery, up to 28 weeks|||percentage of participants with event||95% Confidence Interval|Number
94350|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).||percentage of participants with pCR||95% Confidence Interval|Number
94351|NCT00861705|Secondary|Recurrence-free Survival|From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause.|up to 10 years||10/2018||||
94352|NCT00861705|Secondary|Overall Survival|From study entry to death due to any cause|up to 10 years||10/2018||||
94353|NCT00861705|Secondary|Clinical Response Assessed by Tumor Measurement|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|Baseline; at completion of neoadjuvant therapy||10/2018||||
94354|NCT00861705|Secondary|Radiographic Response Assessed by Tumor Measurement|Assessed by RECIST|Baseline; at completion of neoadjuvant therapy||10/2018||||
94355|NCT00861705|Secondary|Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)||at definitive surgery, up to 28 weeks||10/2018||||
94356|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3).|At the time of definitive surgical removal, up to 28 weeks|||percentage of participants with pCR||95% Confidence Interval|Number
94357|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain carboplatin (arms 3&4) versus not (arms 1&2).|At the time of definitive surgical removal, up to 28 weeks|||percentage of participants with pCR||95% Confidence Interval|Number
94358|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3&4) versus not (arms 1&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).||percentage of participants with pCR||95% Confidence Interval|Number
94359|NCT00861692|Primary|Number of Patients With Platelet Count Recovery|Platelet increase of ≥ 100G/L or 50%.|Day 3|Data are missing in 3 patients.||participants|||Number
94360|NCT00861692|Primary|Number of Patients With Major or Minor Bleeding|"Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial.~Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding."|During and 30 days after argatroban treatment|||participants|||Number
94361|NCT00861692|Primary|Number of Patients With Unplanned Amputation||During and 30 days after argatroban treatment|||participants|||Number
94362|NCT00861692|Primary|Number of Patients With Thrombosis (New and Extended)||During and 30 days after argatroban treatment|||participants|||Number
94363|NCT00861692|Primary|Death Related to Heparin-induced Thrombocytopenia (HIT)||During and 30 days after argatroban treatment|||participants|||Number
94364|NCT00861692|Primary|All-cause Death||During and 30 days after argatroban treatment|||participants|||Number
94365|NCT00861692|Primary|Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation||During and 30 days after argatroban treatment|||participants|||Number
94366|NCT00861614|Secondary|Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade renal function as measured by creatinine analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr).Gr 0: within normal range. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
94367|NCT00861614|Secondary|Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade serum chemistry as measured by lipase and amylase analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for lipase: Gr1: > 1.0 - 1.5 * ULN; Gr2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0*ULN. Abnormal values for amylase: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
94368|NCT00861614|Secondary|Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade liver function as measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
94393|NCT00861601|Secondary|Percent Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|FAS||Percent change||95% Confidence Interval|Mean
94464|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 1|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 1|FAS (LOCF)||participants|||Number
94369|NCT00861614|Secondary|Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade hematology laboratory tests as measured by white blood count (WBC), absolute neutrophil count (ANC), platelet count, hemoglobin and lymphocyte results. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for WBC were based on Gr 1: 3.0 - < Lower Limit of Normal (LLN); Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Abnormal values for Hemoglobin were based on Gr 1: 10.0 - < LLN; Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for ANC were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < LLN; Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to 70 days after last dose of study drug|All treated participants||participants|||Number
94370|NCT00861614|Secondary|Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0|"Time between the date of onset of an imAR to the date of resolution date of the event or the last known date participant was alive if an event did not resolve.~Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to 70 days after last dose of study drug|All treated participants receiving Ipilimumab + Radiotherapy||weeks||Full Range|Median
94371|NCT00861614|Secondary|Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)|"The time between first dose of study drug and date of earliest Grade 3 or 4 imAR. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies and graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.~Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to time of onset of the imAR of interest|All treated participants receiving Ipilimumab + Radiotherapy||weeks||Full Range|Median
94372|NCT00861614|Secondary|Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)|Time between the date of onset of a Grade 3 or 4 irAE and the date of improvement to Grade 1 or less or the worst grade at baseline.|Day 1 to 70 days after last dose of study drug|All treated participants||weeks||95% Confidence Interval|Median
94373|NCT00861614|Secondary|Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)|The time between first dose of study drug and date of earliest Grade 3 or 4 irAE. These irAEs are AEs of unknown etiology, consistent with an immune phenomenon and considered as causally related to drug exposure. The five subcategories of irAE examined include gastrointestinal (GI), liver, skin, endocrine, and neurological and are graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.|Day 1 to 70 days after last dose of study drug|All treated participants||weeks||95% Confidence Interval|Median
94374|NCT00861614|Secondary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug and grouped into gastrointestinal (GI), hepatic, skin, endocrine and neurological. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies. IrAEs/ imARs were graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0."|Randomization to date of death|All treated participants||participants|||Number
94375|NCT00861614|Secondary|Duration of Pain Response|The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date.|Day of initial pain response to day of completion of pain response or date of death|All pain-evaluable participants with pain response||months||95% Confidence Interval|Median
94376|NCT00861614|Secondary|Pain Response|The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period.|Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit|All pain-evaluable participants||percentage of participants||95% Confidence Interval|Number
94377|NCT00861614|Secondary|Progression Free Survival (PFS)|All PFS events were based on investigator’s assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date.|Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death|All randomized participants||months||95% Confidence Interval|Median
94378|NCT00861614|Primary|Overall Survival Rate|The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Date of randomization to date of death|All randomized participants||percentage of participants||95% Confidence Interval|Number
94425|NCT00860470|Secondary|Moderate to Late Preterm|Risk of birth between 32 and 37 weeks gestation|December 2014|||participants|||Number
94380|NCT00861601|Secondary|Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. AUC(0-t)=area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration, and AUC(0-24)=area under the concentration-time curve from 0 (pre-dose) to 24 hours.|Day 14, Day 15|PK Parameter Population||hours * ng/ml||95% Confidence Interval|Geometric Mean
94381|NCT00861601|Secondary|Log-transformed Tmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Tmax=maximum drug concentration time.|Day 14, Day 15|PK Parameter Population||hours||95% Confidence Interval|Geometric Mean
94382|NCT00861601|Secondary|Log-transformed Cmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Cmax=maximum drug concentration.|Day 14, Day 15|PK Parameter Population: all participants from whom a PK sample was obtained and analyzed and whose PK parameter data was evaluated. One of the 12 participants took a prohibited medication that might have decreased the absorption of eltrombopag during the treatment period and was hence excluded from the PK Parameter Population.||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
94383|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Age|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of participants in each age category are illustrated by the n's in the category titles."|Baseline, Day 15|FAS||10^9/Liter||Standard Deviation|Mean
94384|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Sex|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of females and males in each treatment group are illustrated by the n's in the category titles."|Baseline, Day 15|FAS||10^9/Liter||Standard Deviation|Mean
94385|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class|Change from Baseline was calculated as the Day 15 value minus the Baseline value. The Child-Pugh (CP) score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score >=10 is classified as Class C (severe). Participants with a CP score <10 were enrolled in the study.|Baseline, Day 15|FAS. The number of participants categorized as Class A or Class B is given in the category titles.||10^9/Liter||Standard Deviation|Mean
94386|NCT00861601|Secondary|Percentage of Responders on Day 22|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 22 after receiving eltrombopag for an additional week from Day 15, on which his or her platelet count was <80 x 10^9/Liter.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.||percentage of responders||95% Confidence Interval|Mean
94387|NCT00861601|Secondary|Percentage of Responders on Day 15|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 15.|Day 15|FAS||percentage of responders||95% Confidence Interval|Mean
94388|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw. Change from Baseline was calculated as the value at each visit minus the Baseline value.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Standard Deviation|Mean
94389|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22. Change from Baseline was calculated as the value at each visit minus the Baseline value.|Baseline, Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Standard Deviation|Mean
94390|NCT00861601|Secondary|Platelet Counts at Day 22|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.||10^9/Liter||Full Range|Median
94391|NCT00861601|Secondary|Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Full Range|Median
94392|NCT00861601|Secondary|Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.||10^9/Liter||Full Range|Median
94426|NCT00860470|Secondary|Very Pre-term|Risk of birth between 28 and 32 weeks of gestation|December 2014|||participants|||Number
94394|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts and Child-Pugh class as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS||10^9/Liter||95% Confidence Interval|Mean
94395|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS||10^9/Liter||95% Confidence Interval|Mean
94396|NCT00861601|Primary|Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|Full Analysis Set (FAS): all enrolled participants, excluding those who received no doses of eltrombopag during the treatment period, those without a baseline platelet assessment, and those without at least one on-therapy (scheduled or unscheduled) platelet assessment.||10^9/Liter||95% Confidence Interval|Mean
94397|NCT00861471|Secondary|Median Overall Survival Time|Overall survival time is the time from the start of therapy till death. Median overall survival reported here is the time when 50% of the participants are alive.|up to 4 years|Based on intent-to-treat population||months||95% Confidence Interval|Median
94398|NCT00861471|Secondary|Time to PSA Progression|Time to PSA pregression is defined as the time at which therapy statred and ends when the PSA increased by 50% above the nadir confirmed on a second determination.|up to 2 years|Based on intent-to-treat population||days||95% Confidence Interval|Mean
94399|NCT00861471|Secondary|Percentage of Participants With Measurable Disease Response|Measurable disease response is defined as the number of participants whose best response is complete response or partial response over the number of patients with measurable desease according to the Response Evaluation Criteria in Solid Tumors (RECIST).|up to 2 years|Based on the participants with measurable disease||percentage of participants|||Number
94400|NCT00861471|Secondary|Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression|PSA was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population||percentage of participants|||Number
94401|NCT00861471|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response is defined as a greater than or equal to a 50% decrease in PSA from the baseline without clinical or radiologic evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST). PSA concentration was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population.||percentage of participants|||Number
94402|NCT00861341|Primary|Percent Platelet Aggregation Induced by Collagen|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using collagen (2ug.mL). At each time point the results are shown for maximum percent aggregation with collagen for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|baseline and day 6-9|||maximum percentage aggregation||Standard Deviation|Mean
94403|NCT00861341|Primary|Percent Platelet Aggregation Induced by Arachidonic Acid|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using arachidonic acid (0.5 mM). At each time point the results are shown for maximum percent aggregation with arachidonic acid for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|at baseline and days 6-9|Analysis population determined per protocol.||maximum percentage aggregation||Standard Deviation|Mean
94404|NCT00861263|Primary|Number of Patients With Persistent or Recurrent Bleeding|The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.|up to 6 yrs after after the endoscopy|||participants|||Number
94405|NCT00861198|Primary|Successful Procedure Completion|Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings.|baseline|||participants|||Number
94406|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|2 weeks|||participants|||Number
94407|NCT00861146|Secondary|Proportion of Days Heavy Drinking|Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.|follow-up weeks 9-12|||proportion of days||Standard Deviation|Mean
94408|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|12 weeks|||participants|||Number
94409|NCT00860951|Primary|Accuracy of Typing With BCI Keyboard.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.~Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|mean score from 3 sessions over 29 days|||percentage accuracy||Full Range|Mean
94410|NCT00860847|Secondary|1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH||1 year||||||
94411|NCT00860847|Primary|Rate of Change in Total Coronary Calcium Scores by Computed Tomography|progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.|1 year|all participants were analyzed||Agatston score change||Standard Deviation|Mean
94412|NCT00860795|Secondary|Maximal Levels of Interleukin 12 (pg/ml)|interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat||interleukin 12 level (pg/ml)||Standard Deviation|Mean
94413|NCT00860795|Secondary|Maximal Levels of Interleukin 6 (pg/ml)|interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat||interleukin 6 level (pg/ml)||Standard Deviation|Mean
94414|NCT00860795|Secondary|Maximal Levels of Interleukin 2 (pg/ml)|interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|intention to treat||interleukin 2 level (pg/ml)||Standard Deviation|Mean
94415|NCT00860795|Secondary|Adverse Effects||30 days|intention to treat||participants|Participants||Number
94416|NCT00860795|Secondary|Maximal CD25/69 Activation (% of NK CD25/69+ Cells)|NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation|10 days|intention to treat||(% of NK CD25/69+ cells)||Standard Deviation|Mean
94417|NCT00860795|Secondary|Maximal Levels of Interferon Alpha (pg/ml)|interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat||interferon alpha level (pg/ml)||Standard Deviation|Mean
94418|NCT00860795|Primary|Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)|tumor necrosis factor alpha NK cells and evidence of CD25/69 activation|10 days|Intention to treat||tumor necrosis alpha level (pg/ml)||Standard Deviation|Mean
94419|NCT00860743|Primary|Heart Rate Variability (Aim 2)|Heart rate variability (HRV) was measured before and after exposure to intermittent hypoxia following administration of a placebo or antioxidant cocktail. Heart rate variability refers to beat-to-beat alterations in heart rate. Under resting conditions, the electrocardiogram of healthy individuals reveals periodic variation in R-R intervals. To measure HRV, R-R interval data are presented in a graph, in which the y-axis plots the R-R intervals (ms2), and the x-axis the total number of beats. Spectral analysis of the graph transforms the signal from time to frequency on the x-axis (Hz), by representing the signal as a combination of sine and cosine waves, with different amplitudes and frequencies. The approach uses Fourier transforms. The heart rate spectrum contains a high frequency (0.15-0.4 Hz) component, which is synchronous with respiration and a low frequency (0.04 to 0.15 Hz) component that appears to be mediated by both the vagus and cardiac sympathetic nerves.|Within the same experimental session|Measurements were made before and after intermittent hypoxia following administration of a placebo or antioxidant cocktail. Please note that analysis of the heart rate variability measures for the healthy group have not been completed to date.||ms2/Hz||Standard Error|Mean
94420|NCT00860743|Primary|Ventilation (Aim 1)|Ventilation was measured before and after exposure to intermittent hypoxia in males and females. Ventilation was measured using a pneumotachograph, which is a flow measuring device.|Within the same experimental session|||fraction of baseline||Standard Error|Mean
94421|NCT00860535|Primary|Growth Factor Signature (GFS) Change From Baseline Measured by Time Weighted Average (TWA) for Days 1 to 22|"The GFS was measured by microarray analysis using the entire 101 gene signature.~The TWA is the area under the curve (AUC) divided by the time interval (for this study it was the AUC of gene-expression divided by Days 1 to 22).~Participants with blast phase Ph+ CML or Ph+ ALL were measured for change in the GFS post-treatment when treated with imatinib, dasatinib, or nilotinib, using Microarray. Change was represented as the GFS Fold Ratio of TWA for Days 1 to 22 to Baseline."|Baseline to 22 Days After Initiation of Therapy|||GFS Fold Ratio-TWA[Days1-22] to baseline||90% Confidence Interval|Mean
94422|NCT00860535|Primary|Growth Factor Signature (GFS) Variability at Baseline|"The GFS was measured by microarray analysis using the entire 101 gene signature. The GFS is quantified as the change in gene expression between two separate samples collected from the same patient. The signature has 101 genes in two oppositely regulated arms, which are pre-specified. The expression of genes in the UP arm goes up with increasing pathway activity, and the expression of genes in the DOWN arm goes down with increasing pathway activity.~The GFS variability was represented by the GFS change between two baseline samples (Mean GFS Fold Ratio [Screening to Day 1 Predose])."|Screening to Day 1 Predose|Participants whose GFS was measured using microarrays to determine the pretreatment baseline variability in participants with blast phase Ph+ CML or Ph+ ALL.||GFS Fold Ratio-Screening to Day1 Predose||90% Confidence Interval|Mean
94423|NCT00860470|Secondary|Small for Gestation Age|Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).|December 2014|||participants|||Number
94424|NCT00860470|Secondary|Low Birth Weight|Birth weight below 2500g|December 2014|||participants|||Number
94434|NCT00860457|Primary|Complete Response Rate|Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.|3 years|||percentage of patients|||Number
94435|NCT00860405|Other Pre-specified|Acute Renal Failure (ARF)|Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.|From baseline until 2nd postop morning.|Safety Population (SAF) = All randomized patients treated with study drug.||Participants|||Number
94436|NCT00860405|Other Pre-specified|Mortality|Mortality was reported for the time period from screening until the end of follow-up.|From screening to end of follow-up|Safety Population (SAF) = All randomized patients treated with study drug||Participants|||Number
94437|NCT00860405|Other Pre-specified|Length of Stay on the Intensive Care Unit (ICU)|Length of stay (number of days) on the intensive care unit (ICU).|From admission to ICU until discharge from ICU|Safety Population (SAF) = All randomized patients treated with study drug.||Days||Inter-Quartile Range|Median
94438|NCT00860405|Other Pre-specified|Calculated Perioperative Red Blood Cell (RBC) Loss|"Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit [baseline] – hematocrit [2nd postop morning]) + transfused RBC volume2;~Predicted blood volume (mL) = 80 × body weight (kg)~Transfused RBC volume = 0.7 × infused packed RBC"|2 days|Safety Population (SAF) = All randomized patients treated with study drug.||ml/kg||Standard Deviation|Mean
94439|NCT00860405|Secondary|Fluid Balance|Balance of total fluid input and total fluid output|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.||ml/kg||Standard Deviation|Mean
94440|NCT00860405|Secondary|Fluid Output|Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.||ml/kg||Standard Deviation|Mean
94441|NCT00860405|Secondary|Fluid Input|Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation||ml/kg||Standard Deviation|Mean
94442|NCT00860405|Secondary|Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation||mm Hg||Standard Deviation|Mean
94443|NCT00860405|Primary|Total Volume of Colloid Solution Required Intraoperatively|Total volume of study drug plus rescue colloid, if applicable|Day 1 (intraoperatively)|Per-protocol population (PP) = All patients in the Intention-to-treat (ITT) set without any major protocol violation.||ml/kg||Standard Deviation|Mean
94444|NCT00860314|Secondary|Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position|Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.|30 seconds after cardioversion|||participants|||Number
94445|NCT00860314|Secondary|Mean Energy Requirement for Successful Cardioversion|Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.|30 seconds after cardioversion|||Joules||Standard Deviation|Mean
94446|NCT00860314|Primary|Number of Successfully Cardioverted Participants for Each Electrode Position|After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.|30 seconds after cardioversion|||participants|||Number
94447|NCT00860314|Secondary|Mean Number of Cardioversion Shocks||30 seconds after cardioversion|||Shocks||Standard Deviation|Mean
94448|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 8|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 8|FAS (LOCF)||participants|||Number
94449|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 6|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 6|FAS (LOCF)||participants|||Number
94450|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 4|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 4|FAS (LOCF)||participants|||Number
94451|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 8|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 8|FAS (LOCF)||participants|||Number
94452|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 6|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 6|FAS (LOCF)||participants|||Number
94453|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 4|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 4|FAS (LOCF)||participants|||Number
94454|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 8|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 8|FAS (LOCF)||participants|||Number
94455|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 6|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 6|FAS (LOCF)||participants|||Number
94456|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 4|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 4|FAS (LOCF)||participants|||Number
94457|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 8|SBP < 140 mmHg and DBP < 90 mmHg|week 8|FAS (LOCF)||participants|||Number
94458|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 6|SBP < 140 mmHg and DBP < 90 mmHg|week 6|FAS (LOCF)||participants|||Number
94459|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 4|SBP < 140 mmHg and DBP < 90 mmHg|week 4|FAS (LOCF)||participants|||Number
94460|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 8|DBP < 90 mmHg|week 8|FAS (LOCF)||participants|||Number
94461|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 6|DBP < 90 mmHg|week 6|FAS (LOCF)||participants|||Number
94462|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 4|DBP < 90 mmHg|week 4|FAS (LOCF)||participants|||Number
94472|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 1|Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg|week 1|Full analysis set, imputation method used was last observation carried forward (LOCF).||participants|||Number
94473|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in DBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94474|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in DBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94475|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in DBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94476|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in DBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94477|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8|Overall mean reduction from a common mean baseline in DBP|baseline and week 8|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94478|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in SBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94479|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in SBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94480|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in SBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94481|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in SBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94482|NCT00860262|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8|Overall mean reduction from a common mean baseline in SBP|baseline and week 8|Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug.||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
94483|NCT00860249|Primary|Completion of CRC Screening|What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months from initial contact|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.||participants|||Number
94484|NCT00860249|Secondary|The Secondary Outcome for the Study is the Time to Screening Completion.|This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months after randomization|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.||participants|||Number
94485|NCT00860158|Secondary|To Estimate Safety and Tolerability of LHRH Plus Dasatinib||18 months||||||
94486|NCT00860158|Secondary|To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers||18 months||||||
94487|NCT00860158|Secondary|To Estimate Progression Free Survival||18 months||||||
94488|NCT00860158|Secondary|To Estimate PSA Response Rate||18 months||||||
94489|NCT00860158|Secondary|To Estimate Partial Pathologic Responses (pPR)||18 months||||||
94490|NCT00860158|Primary|To Estimate the Pathologic Complete Response (pCR) Rate||18 months|No participants were analyzed for pCR due to study termination|||||
94491|NCT00860067|Secondary|Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
94573|NCT00859430|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
94492|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
94493|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
94494|NCT00860067|Secondary|The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).||participants|||Number
94495|NCT00860067|Secondary|The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14|The Evaluable Safety Population for solicited symptoms included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1197; All FM=597).||participants|||Number
94496|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1182; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and were seropositive to the strain (Q=930; FV=231).||participants|||Number
94497|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had post-dose HAI measurement (Q=1182; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were seropositive to the strain (Q=983; FY=249).||participants|||Number
94498|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1182; AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=373; All FM=196).||participants|||Number
94499|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590) and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=291; All FM=160).||participants|||Number
94500|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and serosusceptible (Q=250; FV=66).||participants|||Number
94501|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were serosusceptible to the strain (Q=197, FY=43).||participants|||Number
95321|NCT00854113|Primary|AUC 0 -24|Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||ng*hr/ml||Standard Deviation|Mean
94502|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).||participants|||Number
94503|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, All FM=600), had post-dose HAI measurement (Q=1182; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181, All FM=589), and were serosusceptible to the strain(Q=889, All FM=429).||participants|||Number
94504|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose.||Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301; All FM=600,), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=290), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=298; All FM=590).||participants|||Number
94505|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FV=301), had pre-dose and post-dose HAI measurement (Q=1181, FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were seropositive to the strain (Q=930, FV=231).||participants|||Number
94506|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had pre-dose and post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q1180; FY=292), and were seropositive to the strain (Q=983, FY=249).||participants|||Number
94507|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, AFM=600), had pre-dose and post-dose HAI measurement (Q=1181, AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=373, All FM=196).||participants|||Number
94508|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=291; All FM=160).||participants|||Number
94509|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had pre-dose and post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were serosusceptible to the strain (Q=250; FV=66).||participants|||Number
94510|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had pre-dose and post-dose HAI measurement (Q=1181; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292), and were serosusceptible to the strain (Q=197; FY=43).||participants|||Number
94511|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).||participants|||Number
94512|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=889; All FM=429).||participants|||Number
94513|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=298; FV=300; All FM=598), had pre-dose and post-dose HAI measurement (Q=1181; FY=292; FV=298; All FM=599), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292; FV=297; All FM=589).||participants|||Number
94514|NCT00860067|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301;All FM=600), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=590), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=297; All FM=589).||geometric mean titer||Full Range|Geometric Mean
94515|NCT00860028|Secondary|Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions|Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.||Number of participants|||Number
94516|NCT00860028|Primary|Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions|Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period.|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.||percentage of heavy drinking days||Standard Deviation|Mean
94517|NCT00860028|Primary|Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.|Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions.|Last 4 weeks of treatment|All participants were included in the analysis, assuming an intention to treat method.||Participants|||Number
94518|NCT00859937|Secondary|Changes in Laboratory Correlates|Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.|Baseline and 4 weeks|Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.|||||
94519|NCT00859937|Secondary|Overall Survival|Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.|Up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.||months||90% Confidence Interval|Median
94520|NCT00859937|Primary|Progression-free Survival|Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.|up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.||months||90% Confidence Interval|Median
94521|NCT00859937|Primary|Response Rate|Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 months|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.||participants|||Number
94522|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Safety laboratory measurements were obtained during the Qualification and Lead-In Periods and on Day 1 of the Double-Blind Period and at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. BL was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from BL up to and including the last day of treatment plus 30 days. Liver function abnormality criteria: FDA Guidance for Industry: Premarketing Clinical Evaluation (July 2009). Data after rescue was also included. Abbreviations: Pretreatment (PreRX), upper limit of normal (ULN); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality Low (High) defined: ALP, AST and ALT (>3*ULN); bilirubin (>2*ULN if PreRX <= ULN; >3*ULN if PreRX > ULN); AST or ALT plus (+) bilirubin elevation: AST or ALT >3*ULN and bilirubin >1.5*ULN within 14 days on or after ALT elevation.|Baseline to Week 24/end of treatment plus 30 days|||participants|||Number
94574|NCT00859430|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
94523|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Laboratory samples: Qualification and Lead-In Periods, Day 1, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of Double-Blind Period. Baseline (BL)=last assessment prior to start of first dose of double-blind study medication. Data after rescue included. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); Units per liter (U/L), blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose <54 (>350) mg/dL; creatine kinase (>5*ULN);calcium <7.5 (>=1 mg/dL from ULN and >= 0.5mg/dL from PreRX); sodium <130 or < 120 male/female (>150 mEq/L; potassium <=2.5 (>=6.0) mEq/L; bicarbonate <= 13 mEq/L; inorganic phosphorus: <=1.8 if age 17-65 or <=2.1 if age >=66, (>=5.6 if age 17-65 or >=5.1) mg/dL if age >=66; albumin <=2 (>6) g/dL; urine albumin(alb) / creatinine (creat) ratio (>1800 mg/g)|Baseline to Week 24/end of treatment plus 4 days|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||participants|||Number
94524|NCT00859898|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants|12-Lead electrocardiograms (ECGs) were performed at entry into Lead-In Period Day -7 visit and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -7 for this parameter. Data after rescue included.|Week 24|||participants|||Number
94525|NCT00859898|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Heart rate values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently throughout the study. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||bpm||Standard Error|Mean
94526|NCT00859898|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Blood pressure values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Systolic and Diastolic pressures were measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||mmHg||Standard Error|Mean
94527|NCT00859898|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 13.0. Data after rescue included for all special AEs except hypoglycemia (excluded data after rescue). Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs except hypoglycemia, which excluded data after rescue.||participants|||Number
94528|NCT00859898|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.||participants|||Number
94529|NCT00859898|Secondary|The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants|Adjusted mean change from baseline in total body weight at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg). Body weight measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||kg||Standard Error|Mean
94530|NCT00859898|Secondary|Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%|HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized, treated participants whose Baseline HbA1c was greater than, equal to (>=) 9.0%. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values, whose baseline HbA1c was >=9.0%.||Percent of Hemoglobin||Standard Error|Mean
94531|NCT00859898|Secondary|Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values; N=202, 216, 203, respectively. n=number of responders: 92, 69, 72, respectively. n/N=percent. Percent is then adjusted for baseline HbA1c.||Percent of participants||95% Confidence Interval|Number
94532|NCT00859898|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants|Data after rescue medication was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Mean
94533|NCT00859898|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants|Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non-missing baseline and Week 24 (LOCF) values.||Percent of hemoglobin||Standard Error|Mean
94534|NCT00859833|Primary|Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest)|The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)|2 hours|Analysis was per protocol. All patients with analyzable data were included. 2/30 patients had technical problems with the MRI data that made their data unable to be analyzed.||ratio||Standard Deviation|Mean
94535|NCT00859638|Secondary|Eight Foot Walk Test||4 months||||||
94536|NCT00859638|Secondary|Balance Screen||4 months||||||
94537|NCT00859638|Secondary|Primary Care Resources and Supports||4 months||||||
94538|NCT00859638|Secondary|Patient Assessment of Chronic Illness Care||4 months||||||
94539|NCT00859638|Secondary|Two Minute Walk Test||4 months||||||
94540|NCT00859638|Secondary|Grip Strength||4 months||||||
94541|NCT00859638|Secondary|Rapid Assessment of Physical Activity||4 months||||||
94542|NCT00859638|Secondary|Self-efficacy for Chronic Disease Scale||4 months||||||
94543|NCT00859638|Secondary|Health Care Utilization||4 months||||||
94544|NCT00859638|Secondary|Self-rated Health||4 months||||||
94545|NCT00859638|Primary|Physical Functioning Inventory (PFI)|The PFI is used to assess physical functioning in older adults. It contains 21 tasks from 4 subscales: activities of daily living, instrumental activities of daily living, mobility, moderate activities. A series of questions is used to determine whether the person experiences difficulty in completing a task, the level of difficulty they experience, and any changes to the method and/or frequency of task performance. The PFI is sensitive to steps in the natural history of functional decline that are often not assessed clinically. Range of scores: 0 (most difficulty); 100 (least difficulty).|4 months|||units on a scale||Standard Deviation|Mean
94546|NCT00859586|Secondary|Incidence and Severity Induced GvHD, Proportion of DLI Engraftment, Peak Chimerism, Leukemia Response at Days Post DLI, Residual Leukemia Measured by Patient Chimerism, Leukemia Free Survival From Date Relapse, Safety of Mismatched DLI Procedure...||Severity of GvHD.||||||
94547|NCT00859586|Primary|Overall Recipient Survival at 6-month Post-relapse of Disease|This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.|6 months post-relapse of disease|||participants|||Number
94548|NCT00859573|Secondary|Vital Signs||thrice weekly||||||
94549|NCT00859573|Secondary|Attentional Neurophysiological Measures||week 0, 2, 10||||||
94550|NCT00859573|Secondary|Pre-attentional Neurophysiological Measures||week 0, week 2, week 10||||||
94551|NCT00859573|Primary|Withdrawal Symptoms||thrice weekly||||||
94552|NCT00859573|Primary|Mean Treatment Effectiveness Scores|Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.|thrice weekly from week 3 through week 8|Participants that completed the 2 week residential treatment and entered the outpatient phase with intent to treat and missing urines treated as positive urines.||scores on a scale||Standard Deviation|Mean
94553|NCT00859547|Primary|Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher|Grade 0=normal.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
94554|NCT00859547|Primary|Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher|ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
94555|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels|ULN=upper level of normal. Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
94556|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels|LLN=lower level of normal. Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
94557|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts|Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8–10^9/L. Neutrophils: Grade 0=normal; Grade 1=<LLN–1.5x10^9/L; Grade 2=<1.5–1.0x10^9/L|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.||Participants|||Number
94558|NCT00859547|Secondary|Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody|Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.|At Day 29|Participants who received study drug and had both baseline and on-treatment anti-rThrombin product antibody assessments.||Participants|||Number
94559|NCT00859547|Primary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.|Days 1 through 29, continuously|Participants who received treatment with rThrombin.||Participants|||Number
94560|NCT00859547|Primary|Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment|Days 1 through 29, continuously|Participants who received treatment with rThrombin.||Participants|||Number
94561|NCT00859521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
94562|NCT00859521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
94563|NCT00859521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
94564|NCT00859508|Secondary|Radiographic Evaluation|"Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit)~Adhesion formation~Membrane formation~Abnormal thickening along graft (device implant) site~Brain edema adjacent to graft (device implant) site"|6 months||||||
94565|NCT00859508|Secondary|Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)||up to 6 months||||||
94566|NCT00859508|Secondary|Wound Healing Assessment||up to 6 months||||||
94567|NCT00859508|Secondary|Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)||up to 6 months||||||
94568|NCT00859508|Secondary|Modified Rankin Scale (Patient Function Assessment)||up to 6 months||||||
94569|NCT00859508|Primary|Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele|The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.|6 months|||participants|||Number
94570|NCT00859469|Secondary|Progression-free Survival|Time to radiologic disease progression or death|50 months|||months||95% Confidence Interval|Median
94571|NCT00859469|Secondary|Overall Survival||50 months|ITT||months||95% Confidence Interval|Median
94572|NCT00859469|Primary|Best Response|Radiologic response by RECIST criteria|Two months|intention to treat principle||participants|||Number
94576|NCT00859339|Secondary|Correlate Biomarker Expression|To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)|||||
94577|NCT00859339|Secondary|Progression Free Survival||18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)|||||
94578|NCT00859339|Secondary|Objective Response Rate|To determine the objective response rate for patients with measurable disease according to RECIST.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)|||||
94579|NCT00859339|Secondary|Safety Profile|Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC|18 months|||participants|||Number
94580|NCT00859339|Primary|Pathological Complete Response (pCR) Rate.|number of participants with a pCR|18 months|8 participants were evaluable for pCR||particpants with pCR|||Number
94581|NCT00859313|Primary|Percent of Patients Without Device Failure|Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.|12 hours|||percent|||Number
94582|NCT00859222|Other Pre-specified|Overall Survival (OS) [Phase I]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase I participants were followed for OS up to 12.1 months on this study.|All participants who received at least one dose of the study drug were followed for OS.||months||Full Range|Median
94583|NCT00859222|Secondary|Overall Survival [Phase II]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase II participants were followed for OS up to 27 months on this study.|All participants who received at least one dose of the study drug were followed for OS.||months||Full Range|Median
94584|NCT00859222|Other Pre-specified|6-Month Progression-Free Survival (PFS6) [Phase I]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.||proportion of participants||95% Confidence Interval|Number
94585|NCT00859222|Other Pre-specified|Progression-Free Survival (PFS) [Phase I]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.||months||Full Range|Median
94586|NCT00859222|Secondary|Progression-Free Survival (PFS) [Phase II]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment.|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All PII participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.||months||Full Range|Median
94587|NCT00859222|Secondary|Best Radiographic Response|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles was a median (range) of 2 (1-6) PI Cohort 1, 4.5 (2-6) PI Cohort 2, 6 (2-10) PI Cohort 3, 5 PII GBM and 7 PII AG.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for response.||participants|||Number
94588|NCT00859222|Primary|6-Month Progression-Free Survival (PFS6) [Phase II]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on RANO criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.||proportion of participants||95% Confidence Interval|Number
94589|NCT00859222|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as an adverse event that (a) is related to the LBH589 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 30 days of the study treatment, and (c) meets any of the following criteria: grade 3 thrombocytopenia; grade 4 neutropenia lasting 7 days; grade 4 anemia lasting 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5 x10^9/L; a QT interval corrected for heart rate (QTc) of 500–515 msec that did not stabilize to <480 msec after one week; a second occurrence of QTc 500–515 msec; any QTc >515 msec; any deep vein thrombosis (DVT) or pulmonary embolism (PE) while on fully therapeutic anticoagulation therapy; Grade 3 proteinuria lasting 14 days; or any other clinically significant Grade 3 toxicity despite maximal medical therapy lasting 7 days, any Grade 4 toxicity despite maximal medical therapy; or any Grade 3 or 4 toxicity resulting in study drug discontinuation.|Participants were assessed every 2 weeks while on study; The observation period for DLT evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for DLT.||participants with DLT|||Number
94696|NCT00858247|Secondary|Change in Triglycerides After 12 Weeks of Vitamin D Supplementation|The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
94590|NCT00859222|Primary|LBH589 Maximum Tolerated Dose (MTD) [Phase I]|The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not reached with 0 of 6 DLTs observed in the highest dose cohort but due to safety concerns higher doses of LBH589 with bevacizumab were neither planned nor tested. The RP2D was 30 mg/day orally, 3x per week, every other week.|Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for MTD.||mg/day orally, 3x per wk, every other wk|||Number
94591|NCT00859131|Secondary|Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3||One year|||participants|||Number
94592|NCT00859131|Secondary|Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3||One year|||participants|||Number
94593|NCT00859131|Secondary|Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.||One year|||participants|||Number
94594|NCT00859131|Secondary|Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis||one year|||participants|||Number
94595|NCT00859131|Secondary|Graft Survival at One Year Post-transplant||One year|||participants|||Number
94596|NCT00859131|Secondary|Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.||One year|||Patients|||Number
94597|NCT00859131|Primary|Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.||One year|||participants|||Number
94598|NCT00859053|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Study Discharge (end of study) was Day 4 (healthy participants) or Day 5 (hepatically impaired participants).|Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.|Analysis was done in safety population, defined as all the participants who received study medication.||Participants|||Number
94599|NCT00859053|Primary|The Apparent Volume of Distribution at Steady State (Vss/F)|Apparent volume of distribution was calculated by dividing the product of the dose and mean residence time (MRT) by AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.||mL||Geometric Coefficient of Variation|Geometric Mean
94600|NCT00859053|Primary|Apparent Clearance of Free BMS-790052 (CLu/F)|CLu/F was calculated by dividing the apparent total body clearance (CLT/F) by mean fraction of unbound drug (fu) for both (1 hour and 4 hour post dose) time points combined. Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/ λz, where λz was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.||mL/min||Geometric Coefficient of Variation|Geometric Mean
94601|NCT00859053|Primary|Apparent Total Body Clearance (CLT/F) of BMS-790052|Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK set population.||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
94602|NCT00859053|Primary|Terminal Half-life (T-HALF) of BMS-790052|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||hours||Standard Deviation|Mean
94603|NCT00859053|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||hours||Full Range|Median
94604|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052|AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
94605|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052|AUC(0-T) was calculated by the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
94606|NCT00859053|Primary|Maximum Observed Plasma Concentration (Cmax) of BMS-790052|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analysed for BMS-790052 by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
94607|NCT00859040|Secondary|Overall Survival|Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame.|34 months|||percentage of participants|||Number
94608|NCT00859040|Secondary|Median Time to Progression|Per protocol, the study’s secondary objectives are to be evaluated “for the estimate of median ... PFS ... at time of interest.” At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information.|34 months|"Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up).~[NOTE: The other 2 patients who were treated on study each remain progression-free after > 1000 days.]"||days||Full Range|Median
94609|NCT00859040|Secondary|Median Progression-Free Survival||5 years|||weeks||95% Confidence Interval|Median
94610|NCT00859040|Secondary|To Characterize the Safety and Tolerability of Pasireotide LAR||5 years||||||
94611|NCT00859040|Secondary|Response Rate|"Number of participants to experience complete or partial response on study treatment.~For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. The steroid dose at the time of the scan evaluation should be no greater than the maximum dose used in the first 8 weeks from initiation of therapy."|5 years|||participants|||Number
94612|NCT00859040|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|||percentage of patients|||Number
94613|NCT00859027|Secondary|Bone Turnover Markers||6 and 12 months||||||
94614|NCT00859027|Primary|Bone Mineral Density at Spine at Baseline Bone Mineral Density at Spine at 6 Months|BMD measurement is mean % change of group compared with baseline|% change in BMD at 6 months compared to baseline values at spine and hip|The number that completed the study.||percentage change of BMD from baseline||Standard Error|Mean
94615|NCT00859014|Secondary|Functional Outcome|Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.|90-days|||units on a scale||Inter-Quartile Range|Median
94616|NCT00859014|Primary|Study Related Serious Adverse Events (SR-SAE)|"Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - Events"|2 Years|||Events|||Number
94617|NCT00858962|Primary|Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)|PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.|6-14 days after beginning co-administration of drugs|All subjects who completed study were included in the analysis.||hr*ng/mL||Standard Deviation|Mean
94618|NCT00858858|Primary|Protection Against DNA Damage by UDCA|p-H2AX levels are a measure of DNA damage. Our major outcome measure is the change in p-H2AX levels, expressed as relative densitometry units, after DCA perfusion in patients treated with oral UDCA. If UDCA protects against bile acid-induced DNA damage, then p-H2AX levels before and after perfusion should not change significantly.|After 8 weeks of UDCA treatment|Patients with Barrett's esophagus, only metaplastic epithelium evaluated. No data were collected from squamous epithelium as originally planned because our in vitro studies subsequently showed that DCA exposure did not cause DNA damage in squamous cells and, therefore, oral UDCA treatment would be meaningless for squamous esophagus.||Relative Densitometry Units||Standard Error|Mean
94619|NCT00858845|Other Pre-specified|Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity will be measured as bursts sympathetic nerve activity per minute.|3 months||||||
94620|NCT00858845|Secondary|Muscle Fiber Type|Fibers witll be typed as I or II according to presence of myosin heavy chain|Measured at Month 3||||||
94621|NCT00858845|Primary|Citrate Synthase Activity|Citrate synthesis is an estimate of mitochondrial activity|Measured at Month 3|||micromole/min/100mg wet weight||Standard Error|Mean
94622|NCT00858832|Primary|Endometritis Incidence|Number of participants who developed endometritis|One year|||participants|||Number
94623|NCT00858780|Secondary|Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization|Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS.|Randomization (Week 0) up to Week 48|m-ITT analysis set.||percentage of participants|||Number
94987|NCT00856739|Primary|Gait Knee Adduction Moment||baseline or first and only visit.|Obese were compared to healthy weight subjects. No overweight subjects were used in this analysis. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.||percent body weight (N)*height (m)||Standard Deviation|Mean
94624|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Full Range|Median
94625|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
94626|NCT00858780|Secondary|Magnetic Resonance Imaging (MRI) Findings at Randomization|MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
94627|NCT00858780|Secondary|Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||units on a scale||Full Range|Median
94628|NCT00858780|Secondary|Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mg/L||Full Range|Median
94629|NCT00858780|Secondary|Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A higher rate is consistent with inflammation.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mm/hour||Full Range|Median
94630|NCT00858780|Secondary|Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||minutes||Full Range|Median
94631|NCT00858780|Secondary|Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.||mm||Standard Error|Least Squares Mean
94632|NCT00858780|Secondary|Participant Pain Visual Analog Scale (VAS) at Randomization|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0)|m-ITT analysis set.||mm||Standard Deviation|Mean
94633|NCT00858780|Secondary|Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants answered “in general how would you rate your health over the last 2-3 weeks?” Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.||mm||Standard Error|Least Squares Mean
94634|NCT00858780|Secondary|Participant General Health Visual Analog Scale (VAS) at Randomization|Participants answered “in general how would you rate your health over the last 2-3 weeks?” Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.|Randomization (Week 0)|m-ITT analysis set.||mm||Standard Deviation|Mean
94635|NCT00858780|Secondary|Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mm||Full Range|Median
94636|NCT00858780|Secondary|Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||mm||Full Range|Median
94637|NCT00858780|Secondary|Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||swollen joints||Full Range|Median
94638|NCT00858780|Secondary|Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.||tender joints||Full Range|Median
94639|NCT00858780|Secondary|Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48|DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and <2.6=remission.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
94640|NCT00858780|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 implied low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and less than (<) 2.6=remission.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
94641|NCT00858780|Secondary|Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State|Participants who had DAS28 <=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100.|Randomization (Week 0) up to Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.||percentage of visits||Standard Deviation|Mean
94642|NCT00858780|Secondary|Percentage of Participants With Remission or Low Disease Activity (LDA)|Participants who had DAS28 less than or equal to (<=) 3.2 were considered in remission or LDA state.|Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time-point for each treatment arm, respectively.||percentage of participants|||Number
94643|NCT00858780|Secondary|Time to Treatment Failure (TTF)|TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.|Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)|m-ITT analysis set.||weeks||95% Confidence Interval|Median
94644|NCT00858780|Primary|Percentage of Participant Who Were Non-Failures|A participant was considered as non-failure if the calculated DAS28 <=3.2 at all visits or if the calculated DAS28 >3.2, the increase of calculated DAS28 from randomization (Week 0): was <0.6 at all visit or was >=0.6 but <1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.|Week 48|Modified intent-to-treat (m-ITT) analysis set included all randomized participants who received at least 1 dose of study medication after randomization and had at least 1 available evaluation after the first administration of study medication after randomization.||percentage of participants|||Number
94645|NCT00858702|Secondary|Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)|Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.||Percent of participants|||Number
94697|NCT00858247|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
94646|NCT00858702|Secondary|Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)|Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.||Percent of participants|||Number
94647|NCT00858702|Primary|The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85||Baseline to week 8|Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.||Percent of participants|||Number
94648|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||1 year||||||
94649|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||8 weeks||||||
94650|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||1 year||||||
94651|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||8 weeks||||||
94652|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||1 year||||||
94653|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||8 weeks||||||
94654|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||1 year||||||
94655|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||8 weeks||||||
94656|NCT00858689|Secondary|Stanford Binet 5 (SB5)||1 year||||||
94657|NCT00858689|Secondary|Clinical Global Impression Scale||1 year||||||
94658|NCT00858689|Secondary|Clinical Global Impression Scale||8 weeks||||||
94659|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||1 year||||||
94660|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||8 weeks||||||
94661|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||Baseline||||||
94662|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||Baseline||||||
94663|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||Baseline||||||
94664|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||Baseline||||||
94665|NCT00858689|Secondary|Stanford Binet 5 (SB5)||Baseline||||||
94666|NCT00858689|Secondary|Clinical Global Impression Scale||Baseline||||||
94667|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||Baseline||||||
94668|NCT00858689|Primary|ABC Irritability Subtest Score|ABC (Aberrant behavior checklist) Irritability subtest score was used|1 year||||||
94669|NCT00858689|Primary|ABC Irritability Subtest Score|ABC Irritability subtest score was used|8 weeks|completed 8 weeks of minocycline treatment||units on a scale||Standard Deviation|Mean
94670|NCT00858689|Primary|Change From Baseline of ABC Irritability Subtest Score at 8 Weeks|The 15-item Irritability Scale includes questions about aggression, self-injury, tantrums, agitation, and unstable mood on a scale of 0 to 45 with higher scores indicating greater severity. This scale has been successfully used in previous medication studies in children with autism and in patients with FXS and in a controlled trial of ampakine CX516 in FXS. All ABC subscales showed good reliability when used by parents and caregivers of individuals with FXS to assess behavior in the CX516 study NCT00054730, and yielded intraclass correlation coefficient (ICC) values of 0.7-0.9.|Baseline and 8 weeks|ABC-I change in subjects completing 8 weeks of minocycline treatment||units on a scale||Standard Deviation|Mean
94671|NCT00858637|Secondary|Vital Signs, Adverse Events, and Laboratory Values||throughout study||||||
94672|NCT00858637|Secondary|Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)||16 weeks and 20 weeks||||||
94673|NCT00858637|Secondary|Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)|Percent Change from Baseline to Week 16 (LOCF)|week16 minus week0|ITT1 population included all subjects who received a randomisation number, took at least 1 dose of study medication and had at least 1 central serum LDL-C value after the start of study medication.||Percent Change of LDL-cholesterol||Standard Deviation|Mean
94674|NCT00858637|Primary|Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)|Percent Change from Week 16 to Week 20 (LOCF)|week20 minus week16|ITT2 population included all re-randomised subjects who completed 16 weeks in the active treatment groups (MCI-196 or simvastatin), received at least 1 dose of study medication in the Placebo-controlled withdrawal phase and had at least 1 central serum LDL-C value after Week 16.||Percent Change of LDL-cholesterol||Standard Deviation|Mean
94675|NCT00858507|Primary|Receipt of Primary Care at the VA|The primary aim of this study was to conduct a randomized controlled trial of different interventions aimed at increasing rates of treatment engagement among a community sample of treatment-naive homeless veterans.|within 4 weeks of intervention|||participants|||Number
94676|NCT00858494|Secondary|Parental Report of an Adverse Event After a Dose of Study Medication|After each dose of study medication parents reported the presence of any adverse events|data collected after doses occurring up to 10 days after index visit|Study logs were returned in 37 of 49 enrolled participants. After each dose of study medication, the participant's parent indicated in the study log whether any adverse events were noted.||doses|Participants||Number
94698|NCT00858247|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
94699|NCT00858247|Secondary|Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation|Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/dL||Standard Deviation|Mean
94677|NCT00858494|Primary|Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.|For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.|up to 10 days from index visit|Some symptoms were not present at each dose of the homeopathic remedy. Number of doses at which symptom was present: runny nose: 135, nasal congestion: 152, cough: 154, sneezing 81. The outcome is number of times improvement in each symptom was noted.||doses|Participants||Number
94678|NCT00858494|Secondary|Side Effects Related to the Study Medication||10 days||||||
94679|NCT00858494|Primary|Severity of Cold Symptoms||one hour after receiving dose||||||
94680|NCT00858468|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.|Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.|21 days post-vaccination 2|GMTs were assessed on the Per-Protocol Population||Titers||95% Confidence Interval|Geometric Mean
94681|NCT00858468|Other Pre-specified|Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).|Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.|21 days post-vaccination 2|Seroconversion analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.||Percentage of participants|||Number
94682|NCT00858468|Other Pre-specified|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).|"Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.~Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40"|21 days post-vaccination 2|Seroprotection analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.||Percentage of participants|||Number
94683|NCT00858468|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.|Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intend-to-treat population||Percentage of participants|||Number
94684|NCT00858442|Secondary|Length of the Graft|Central length measurement graft between the start and the end of the compression|start and end compression|||centimeter|Participants|Inter-Quartile Range|Median
94685|NCT00858442|Secondary|Width of the Graft|Central width measurement graft between the start and the end of the compression|start and end compression|||centimeter|Participants|Inter-Quartile Range|Median
94686|NCT00858442|Primary|Median Time Between Surgery Date and Start Date Compression.|Participants were followed from the date of surgery and the date of onset of compression for a minimum of 13.5 days and a maximum of 27 days|day|A participant may have one, two or three areas grafted||day|Participants|Full Range|Median
94687|NCT00858403|Secondary|Correlation Between Mutation and Inhibition and to Disease Control Rate and Response|To analyze Kras and epidermal growth factor receptor (EGFR) mutation and their correlation to the ERK pathway inhibition and to disease control rate and response.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
94688|NCT00858403|Secondary|Correlation Between Extent of Inhibition and Concentration of Dasatinib|We planned to explore whether the extent of inhibition of ERK, SRC and Akt phosphorylation in lung cancer cells exposed ex vivo to dasatinib will correlate with the drug concentration of dasatinib.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
94689|NCT00858403|Secondary|Number of Participant Progressors vs. Non-Progressors With Inhibition Response|We planned to assess whether the extent of inhibition of proto-oncogene tyrosine-protein kinase (SRC) and protein kinase B (Akt) phosphorylation in lung cancer cells exposed ex vivo and in vivo to dasatinib significantly differs between patients categorized as progressors or non-progressors through standard RECIST criteria.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
94690|NCT00858403|Secondary|Number of Participants With Serious Adverse Events (SAEs)|We evaluated toxicity of dasatinib in this patient population.|1 year, 4 months|||Participants|||Number
94691|NCT00858403|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|We planned to estimate the 6 month progression free survival rate of dasatinib in this patient population.|1 year, 4 months|We were able to assess 4 of the 7 participants at 6 months.||Participants|||Number
94692|NCT00858403|Secondary|Number of Participants With Response to Dasatinib|We planned to estimate the single agent response rate to dasatinib in this patient population|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
94693|NCT00858403|Primary|Number of Participant Progressors vs. Non-progressors With Tumor Response|We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.|||||
94694|NCT00858390|Primary|Primary Outcome Measure is IL-6 Level|Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.|12+/-2 hours|||pg/ml||Standard Deviation|Mean
94695|NCT00858247|Secondary|Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation|The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.||mg/L||Standard Deviation|Mean
94700|NCT00858247|Primary|Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation|"Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia.~From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance."|Baseline, 12 weeks|All subjects had blood drawn but some tests such as insulin could not be done in some cases due to sample issues. This lab test was calculated from other parameters and not drawn per se. If the values obtained did not allow a calculation of the lab test, then the results could not be reported.||HOMA score||Standard Deviation|Mean
94701|NCT00858208|Other Pre-specified|Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)|IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.|Baseline and Week 102 or ET|SAS; N=participants with evaluable data at baseline; n=participants with evaluable data at specified time point||millimeters of mercury (mmHg)|Participants|Standard Deviation|Mean
94702|NCT00858208|Other Pre-specified|Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study|Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).|Baseline through Week 102|SAS||participants|||Number
94703|NCT00858208|Other Pre-specified|Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS||participants|||Number
94704|NCT00858208|Other Pre-specified|Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS||participants|||Number
94705|NCT00858208|Other Pre-specified|Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS||participants|||Number
94706|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Previous Treatment of AMD|Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants for who data was collected about previous AMD treatment (yes/no); n=number of participants with evaluable data at specified time point||scores on a scale|Participants|Standard Deviation|Mean
94707|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage|Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants with AMD; n=participants with evaluable data at specified time point and stage of AMD||logMAR|Participants|Standard Deviation|Mean
94708|NCT00858208|Other Pre-specified|Change From Baseline VA at Final Visit by Age Group|Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS;N=participants with evaluable data; n=participants with evaluable data at specified time point and age group||logMAR|Participants|Standard Deviation|Mean
94709|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point and item in questionnaire||scores on a scale||Standard Deviation|Mean
94710|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data||scores on a scale||Standard Deviation|Mean
94732|NCT00858143|Secondary|Absolute Glucose Values in Diabetic Patients (Fasting)|Absolute Glucose Values in Patients with Diabetes (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
94711|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Month 6, 12, 18, and 24|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point||scores on a scale||Standard Deviation|Mean
94712|NCT00858208|Secondary|Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)|"VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the Pigment Epithelial Detachment (PED) present box ticked at Baseline Visit."|Baseline, Week 102 or ET|SAS subset of participants with RPED at baseline||logMAR|Participants|Standard Deviation|Mean
94713|NCT00858208|Secondary|Change From Baseline VA at Each Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, every 6 weeks up to Week 102|SAS; Number of participants analyzed (N)=participants with evaluable data; n=participants with evaluable data at specified time point||logMAR|Participants|Standard Deviation|Mean
94714|NCT00858208|Primary|Change From Baseline Visual Acuity (VA) at the Final Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, Week 102 or Early Termination (ET)|Safety Analysis Set (SAS) = Full Analysis Set (FAS): Enrolled participants who received at least 1 dose of Pegaptanib; Number of participants analyzed (N)=participants with evaluable data||logMAR|Participants|Standard Deviation|Mean
94715|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement; n=129).||milligram (mg)|||Number
94716|NCT00858143|Primary|Serious Adverse Events (SAE) and Adverse Events (AE)|Long term safety of Somavert in treatment of patients with acromegaly|Baseline up to 5 years|Safety Population; all patients who received at least one dose of Somavert® during the observation period.||participants|||Number
94717|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set).||milligram (mg)|||Number
94718|NCT00858143|Secondary|Change From Baseline in Ring Size|Change from baseline: ring size at observation minus ring size at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||millimeters||Standard Deviation|Mean
94719|NCT00858143|Secondary|Change From Baseline for Systolic Blood Pressure (BP)|Change: systolic blood pressure at observation minus systolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||millimeters Mercury (mmHg)||Standard Deviation|Mean
94720|NCT00858143|Secondary|Change From Baseline for Diastolic Blood Pressure (BP)|Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||millimeters per mercury (mmHg)||Standard Deviation|Mean
94721|NCT00858143|Secondary|Mean Change From Baseline for Body Weight|Change: body weight at observation minus body weight at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||kilogram (kg)||Standard Deviation|Mean
94746|NCT00858143|Secondary|IGF-I Absolute Values|IGF-I absolute values (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||Standard Deviation|Mean
94722|NCT00858143|Secondary|Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94723|NCT00858143|Secondary|Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94724|NCT00858143|Secondary|Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94725|NCT00858143|Secondary|Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94726|NCT00858143|Secondary|Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94727|NCT00858143|Secondary|Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94728|NCT00858143|Secondary|Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94729|NCT00858143|Secondary|Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.||score on scale||95% Confidence Interval|Mean
94730|NCT00858143|Secondary|Glucose Values Above Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94731|NCT00858143|Secondary|Glucose Values Within Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94733|NCT00858143|Secondary|Glucose Change From Baseline in Diabetic Patients (Fasting)|Change: glucose at observation minus glucose at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||95% Confidence Interval|Mean
94734|NCT00858143|Secondary|HbA 1c Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
94735|NCT00858143|Secondary|HbA 1c Values Below Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Below Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
94736|NCT00858143|Secondary|HbA 1c Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Within Normal Range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94737|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||95% Confidence Interval|Mean
94738|NCT00858143|Secondary|Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||Standard Deviation|Mean
94739|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94740|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94741|NCT00858143|Secondary|Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||Standard Deviation|Mean
94742|NCT00858143|Secondary|Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||95% Confidence Interval|Mean
94743|NCT00858143|Secondary|Absolute Hemoglobin A 1c (HbA 1c) Values|Absolute value Hemoglobin A 1c (HbA 1c)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||Standard Deviation|Mean
94744|NCT00858143|Secondary|Absolute Glucose Values (2h oGTT)|Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
94745|NCT00858143|Secondary|Absolute Glucose Values (Fasting)|Absolute Glucose values (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
94761|NCT00857961|Secondary|Number of Participants With Adverse Events|A listing of adverse events is located in the Reported Adverse Events module.|Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)|All participants received all four doses of testosterone-MD lotion.||participants|||Number
94747|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range|Number of participants with glucose values (2h oGTT) above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94748|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range|Number of participants with glucose values (2h oGTT) within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94749|NCT00858143|Secondary|Glucose Values Above Normal Range (Fasting)|Number of participants with glucose values above normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94750|NCT00858143|Secondary|Glucose Values Below Normal Range (Fasting)|Number of participants with glucose values below normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94751|NCT00858143|Secondary|Glucose Values Within Normal Range (Fasting)|Number of participants who have glucose values within normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94752|NCT00858143|Secondary|Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>|Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
94753|NCT00858143|Secondary|Change From Baseline Glucose (Fasting)|Change: glucose at observation minus glucose at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||milligram per deciliter (mg/dl)||Standard Deviation|Mean
94754|NCT00858143|Secondary|HbA 1c Values Above Normal Range|Number of participants with HbA 1c values above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94755|NCT00858143|Secondary|HbA 1c Values Below Normal Range|Number of participants who have HbA 1c values below normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participants|||Number
94756|NCT00858143|Secondary|HbA 1c Values Within Normal Range|Number of participants who have HbA 1c values within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
94757|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c)|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||percent (%)||Standard Deviation|Mean
94758|NCT00858143|Secondary|IGF-I Values Above Normal Range|Number of participants who have IGF-I values above normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
94759|NCT00858143|Secondary|IGF-I Values Within Normal Range|Number of participants who have IGF-I values within normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||participant|||Number
94760|NCT00858143|Secondary|Change From Baseline Insulin-like Growth Factor I (IGF-I)|Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).|Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).||micrograms per liter (ug/l)||Standard Deviation|Mean
94762|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]|Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||h*ng/dL||Standard Deviation|Mean
94763|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)|Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||percent fluctuation in concentration||Standard Deviation|Mean
94764|NCT00857961|Primary|Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||ng/dL||Standard Deviation|Mean
94765|NCT00857961|Primary|Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||ng/dL||Standard Deviation|Mean
94766|NCT00857961|Primary|Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.||ng/dL||Standard Deviation|Mean
94767|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)|Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion.||hours (h)||Full Range|Median
94768|NCT00857948|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).||Day 1 up to Day 28 post-application|Adverse events were assess in the Safety (Intent-to-treat) Population.||Participants|||Number
94769|NCT00857948|Secondary|Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)|The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.|Day 1 through Day 15 post-application|The level of lice infestation was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of participants|||Number
94770|NCT00857948|Secondary|Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 8 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of participants|||Number
94771|NCT00857948|Primary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 15 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.||Percent of participants|||Number
94772|NCT00857896|Secondary|Post-void Residual (PVR) Volume|Volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, and Week 8 post-dose|Safety Population: all participants who were known to have received study medication; Number of participants analyzed (N) = participants not performing clean intermittent bladder catheterization (CIC); n = participants not performing CIC at specified time point.||mL||Full Range|Median
94773|NCT00857896|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 28 and Day 56|PK Concentration||L/hr||95% Confidence Interval|Mean
94774|NCT00857896|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.||hours||Standard Deviation|Mean
94775|NCT00857896|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.||hours||Standard Deviation|Mean
94776|NCT00857896|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
94777|NCT00857896|Primary|Area Under the Plasma Drug Concentration Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.||mcg*h/mL||Standard Deviation|Mean
94778|NCT00857896|Primary|Apparent Volume of Distribution (VC/F)|The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.|Day 28 and Day 56|PK Concentration||Liters (L)||95% Confidence Interval|Mean
94779|NCT00857896|Primary|Absorption Rate Constant (Ka)||Day 28 and Day 56|Pharmacokinetic (PK) concentration population: randomized and treated participants who had at least 1 concentration during the study.||1/hour (hr)||95% Confidence Interval|Mean
94780|NCT00857818|Primary|Mean Baseline Fasting Non-HDL Levels||At baseline (Day 1)|All randomized patients who took at least 1 dose of study medication during the treatment period.||mg/dL||Standard Error|Mean
94781|NCT00857818|Secondary|Mean Changes in Serum Prolactin Levels From Baseline||Baseline to Weeks 4, 8. and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94782|NCT00857818|Secondary|Median Changes in Body Mass Index From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94783|NCT00857818|Secondary|Mean Changes in Weight From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94784|NCT00857818|Secondary|Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores|The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.|Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94785|NCT00857818|Secondary|Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count|Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, this study was terminated early, and these data were not summarized.|||||
94786|NCT00857818|Secondary|Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94787|NCT00857818|Secondary|Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline||Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94788|NCT00857818|Secondary|Mean Changes From Baseline in Fasting Glucose Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94789|NCT00857818|Secondary|Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.|||||
94790|NCT00857818|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs|AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.|Baseline to Week 16, continuously|All randomized subjects who took at least 1 dose of study medication during the treatment period.||Participants|||Number
94988|NCT00856661|Secondary|Modified Ranking Scale Score (Using the Ordinal Scale)|Please see outcomes measure one for detailed description of the mRS scale|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Scores on a scale||Standard Error|Least Squares Mean
94791|NCT00857818|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels|Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.|Baseline to Weeks 4, 8, and 16|All randomized patients who took at least 1 dose of study medication during the treatment period. The Last Observation Carried Forward (LOCF) data set included data recorded at a given visit. If no observation was recorded at that visit, data was carried forward from the previous visit. .||Percentage of change||Standard Error|Mean
94792|NCT00857792|Primary|Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.||3 months|||% accurately detected perfusion defects|Participants||Number
94793|NCT00857766|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint|FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.||milliliters||Standard Error|Mean
94794|NCT00857766|Secondary|Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint|AIx is a surrogate measure of peripheral (not aortic) arterial resistance and is measured by analysis of the pulse wave at the radial artery. AIx = ([delta P/Pulse Pressure] x 100); delta P is defined by a notch near the peak of the pulse wave. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.||% of total height of peak pulse pressure||Standard Error|Mean
94795|NCT00857766|Primary|Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint|The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.|Baseline and the 12-Week Endpoint (up to Week 12)|Intent-to-Treat (ITT) Population: all participants who were randomized to study drug. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.||meters per second (m/s)||Standard Error|Mean
94796|NCT00857714|Secondary|Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.|Number of patients with toxicity associated with short therapy with lapatinib will be reported.|Up to 60 days|||participants|||Number
94797|NCT00857714|Primary|Number of Patients Where Gene Signature Was Obtained.|Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.|Up to 60 days|||participants|||Number
94798|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.|"Change from Baseline on the Cohen-Mansfield Agitation Inventory (CMAI) - Long Form total score.~CMAI - Long Form looks specifically at agitated behaviour in patients with cognitive impairment. It is a seven-point rating scale assessing the frequency of up to 29 agitated behaviours, ranging from 1 = Never to 7 = Several times an hour. Rating is based on responses obtained from interviews with the caregiver. The total score ranges from 29 to 203, with a higher score reflecting more frequent behavioural disturbances."|Baseline to Week 24|FAS; OC||Scores on a scale||Standard Error|Mean
94799|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.|"Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item version total score.~ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline to Week 24|FAS; OC||Scores on a scale||Standard Error|Mean
94800|NCT00857649|Secondary|Efficacy of Memantine on Global Condition Using CIBIC-plus.|"Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). Improvement evaluated with reference to Baseline.~CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Baseline to Week 24|FAS; Observed Cases (OC).||Scores on a scale||Standard Error|Mean
94801|NCT00857649|Primary|Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.|"Change from Baseline in Severe Impairment Battery (SIB) total score.~SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline to Week 24|FAS; LOCF||Scores on a scale||Standard Error|Mean
94815|NCT00857584|Secondary|Number of Patients With Remission at Week 1.|"Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
95322|NCT00854113|Primary|t1/2|Pharmacokinetics results.t 1/2 - apparent terminal half life|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||hour||Standard Deviation|Mean
94802|NCT00857649|Primary|Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.|"Change from Baseline in Neuropsychiatric Inventory (NPI) total score.~NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline to Week 24|"Full-analysis Set (FAS) – all randomised patients on current treatment with an acetylcholinesterase inhibitor (AChEI) who took at least one dose of investigational medicinal product (IMP) and had at least one post-baseline assessment on both co-primary efficacy variables.~Last Observation Carried Forward (LOCF)."||Scores on a scale||Standard Error|Mean
94803|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.|From baseline to 28 days|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
94804|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.|From baseline to day 28..|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
94805|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.|"Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
94806|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.|"Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
94807|NCT00857623|Secondary|Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” at Day 28.|"Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse.~Responder= Patient with a response of much improved or very much improved Responder rate= (no. of responders/total no. of patients)*100"|28 days|Per Protocol population (PP)||Participants|||Number
94808|NCT00857623|Secondary|Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)||Participants|||Number
94809|NCT00857623|Secondary|Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)||Participants|||Number
94810|NCT00857623|Secondary|Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.|Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.|From baseline to 28 days|Per Protocol population (PP)||Scores on a scale||Standard Deviation|Mean
94811|NCT00857623|Primary|Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment|"Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).~Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable."|From baseline to day 28|Per Protocol population (PP)||Scores on a scale||Standard Error|Least Squares Mean
94812|NCT00857584|Secondary|Number of Patients With Remission at Week 8.|"Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology||Participants|||Number
94813|NCT00857584|Secondary|Number of Patients With Remission at Week 4.|"Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
94814|NCT00857584|Secondary|Number of Patients With Remission at Week 2.|"Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
94816|NCT00857584|Secondary|Number of Patients With Response at Week 8.|"Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
94817|NCT00857584|Secondary|Number of Patients With Response at Week 4.|"Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
94818|NCT00857584|Secondary|Number of Patients With Response at Week 2|"Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
94819|NCT00857584|Secondary|Number of Patients Response at Week 1|"Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||Participants|||Number
94820|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94821|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94822|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94823|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94824|NCT00857584|Secondary|The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94825|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology||score on a scale||95% Confidence Interval|Mean
94826|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline. week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94862|NCT00857246|Secondary|Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy|This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)||percentage of participants|||Number
94827|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94828|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.||score on a scale||95% Confidence Interval|Mean
94829|NCT00857584|Primary|The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. Safety data were analyzed for patients who received at least one dose of study medication.||score on a scale||95% Confidence Interval|Mean
94830|NCT00857532|Secondary|Correlation of Florbetapir SUVR With CSF Biomarker Values|Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables.|50-60 min after injection|Participants were a subset of all subjects enrolled in this study who were also part of an ongoing study looking at the usefulness of CSF biomarkers.||Correlation Coefficient|||Number
94831|NCT00857532|Secondary|Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.|Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.||Correlation Coefficient|||Number
94832|NCT00857532|Primary|Mean Cortical Amyloid Burden|Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.||SUVR||Standard Deviation|Mean
94833|NCT00857506|Secondary|Correlation of Change in ADAS-Cog and SUVR|Correlation between change from baseline to 36 month ADAS-Cog score and baseline global average SUVR by diagnostic group is provided below. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. Standard Uptake Value Ratio (SUVR) is the ratio of tracer uptake in the cortex and cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the cortex as compared to the cerebellum whereas scores less than 1 indicate the opposite.|Baseline and 36 months|||Pearson Correlation Coefficient|||Number
94834|NCT00857506|Secondary|Covariate Adjusted Psychometric Score Change|Change from baseline by diagnostic group in covariate-adjusted psychometric assessment scores at month 36 (LOCF). Assessments included Digit Symbol Substitution (DSS), Clinical Dementia Rating Sum of Boxes (CDR-SOB), Mini-Mental State Examination (MMSE), Wechsler Logical Memory Scale (WLMS) delayed and immediate recall, Category Verbal Fluency (CVF) animals and vegetables, Alzheimer's Disease Clinical Studies Consortium Activities of Daily Living (ADCS ADL) and Geriatric Depression Scale (GDS). The ranges for these scales are as follows: DSS (0-93), CDR-SOB (0-18), MMSE (0-30), WLMS delayed and immediate recall (0-25), CVF animals and vegetables (0-total number of relevant items named in 60 seconds), ADCS ADL (0-78) and GDS (0-15). For all scales except CDR-SOB and GDS a higher score indicates greater cognitive function. For CDR-SOB and GDS a higher score indicates increased dementia or depression, respectively.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Scores on a scale||Standard Error|Mean
94835|NCT00857506|Secondary|Cognitive Decline in CN and AD Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the CN and AD populations with clinically significant deterioration in ADAS-Cog (≥4) and CDR global score (≥0.5). ADAS-Cog scores (range 0-70) indicate performance on a series of cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Participants|||Number
94836|NCT00857506|Secondary|Change in ADAS-Cog in CN and AD Subjects|This analysis compared the magnitude of change from baseline in ADAS cognitive subscale (ADAS-Cog) scores between Aβ+ and Aβ- subjects in the CN and AD populations at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Scores on a scale||Standard Error|Mean
94837|NCT00857506|Secondary|Cognitive Decline in MCI Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the MCI population with clinically significant deterioration in ADAS-Cog (≥4) and Clinical Dementia Rating (CDR) global score (≥0.5) and conversion in diagnosis from MCI at baseline to AD or Cognitively Normal (CN) at 36 months. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Participants|||Number
94838|NCT00857506|Primary|Change in ADAS-Cog for MCI Subjects|The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (last observation carried forward [LOCF]). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).||Scores on a scale||Standard Error|Mean
94839|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||percentage of red blood cells in sample||Standard Deviation|Mean
94840|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||grams per deciliter (g/dL)||Standard Deviation|Mean
94841|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Estradiol||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||picograms per milliliter (pg/mL)||Standard Deviation|Mean
94842|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||mIU/mL||Standard Deviation|Mean
94843|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
94844|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
94845|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).||uIU/mL||Standard Deviation|Mean
94846|NCT00857454|Primary|Change From Baseline MTE08 to MTE09 Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/escar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Day 1, Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at MTE09 endpoint (Day 190).||units on a scale||Standard Deviation|Mean
94847|NCT00857415|Secondary|Regional Correlation Analysis|Spearman's rank order correlation of median visual read of the florbetapir-PET image vs. amyloid plaque density assessed post-mortem by quantitative IHC of six individual brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners||Correlation coefficient||95% Confidence Interval|Number
94848|NCT00857415|Primary|Specificity Analysis|Specificity of florbetapir-PET scan in younger healthy controls presumed to be negative for amyloid. Specificity results are reported as the number of subjects who had a negative scan based on majority of 3 blinded readers.|50-60 min after injection|Per protocol, 27 subjects who were genetic carriers for ApoE e4 or whose genetic status was unknown were excluded from the analysis||participants|||Number
95117|NCT00855959|Secondary|Forced Expiratory Volume in 1 Second (FEV 1.0)|Change in Forced Expiratory Volume in 1 second (FEV 1.0) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L||Standard Deviation|Mean
94849|NCT00857415|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median semi-quantitative visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners||Correlation coefficient||95% Confidence Interval|Number
94850|NCT00857311|Primary|Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)|"Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site.~Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine."|up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs|||Participants|||Number
94851|NCT00857311|Secondary|Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen|"Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).~No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious."|Week 30 (4 weeks after boost injection)|No analysis was performed.|||||
94852|NCT00857311|Secondary|Number of Participants With Systemic and Laboratory Adverse Events (AE)|Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.|up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs|||Participants|||Number
94853|NCT00857285|Primary|Mean Change of Sitting dBP From Baseline to Week 12|The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.|Baseline to 12 weeks|Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation.||mmHg||Standard Error|Mean
94854|NCT00857272|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = “excellent” (no more than small bits of adherent feces/fluid); 3 = “good” (small amounts of feces or fluid not interfering with the exam); 2 = “fair” (enough feces or fluid to prevent a completely reliable exam); 1 = “poor” (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a “success” and grades of 2 or 1 were considered a “failure”.|during colonoscopy|The analysis population consists of patients that were randomized and took any portion of the study preparation and who did not discontinue prior to colonoscopy due to a reason of safety or efficacy.||percent of participants||95% Confidence Interval|Number
94855|NCT00857259|Secondary|Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus|Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart.|Baseline and week 4|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.||Letters||Standard Deviation|Mean
94856|NCT00857259|Primary|Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)|Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center.|Baseline and 4 weeks|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.||µm||Standard Deviation|Mean
94857|NCT00857246|Secondary|Median Overall Survival (Adjuvant Therpary)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who received at least one cycle of adjuvant therapy||months||Full Range|Median
94858|NCT00857246|Secondary|Median Overall Survival (Induction Treatment and Curative Surgery)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who completed induction treatment and underwent curative surgery||months||Full Range|Median
94859|NCT00857246|Secondary|Safety of the Induction Regimen|This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.|4 months from the beginning of the induction|Patients who had at least a dose of treatment||participants|||Number
94860|NCT00857246|Secondary|"Rate of Down-staging From Pre-operative Clinical Staging"|This is defined as the percentage of patients who had a reduction from T3/T4 disease.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)||percentage of participants|||Number
94861|NCT00857246|Secondary|Rate of Potentially Curative Surgery|This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).|4 months from the beginning of the induction treatment|patients who underwent surgery||percentage of participants|||Number
94863|NCT00857246|Primary|Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab|Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any “down-staging” of T or N stage is considered to be a result of induction therapy and counted as a clinical response.|4 months from the beginning of the induction regimen|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)||percentage of paticipants|||Number
94864|NCT00857233|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 24|APTS||percentage of participants|||Number
94865|NCT00857233|Secondary|Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score|"Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only.~ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline and Week 24|APTS; OC||Scores on a scale||Standard Deviation|Mean
94866|NCT00857233|Secondary|Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).|"CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only.~CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Week 24|APTS; OC||Scores on a scale||Standard Deviation|Mean
94867|NCT00857233|Secondary|Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.|"Change from Baseline in the SIB total score. Analysed by descriptive methods only.~SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline and Week 24|APTS; OC||Scores on a scale||Standard Deviation|Mean
94868|NCT00857233|Secondary|Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.|"Change from Baseline in the NPI total score. Analysed by descriptive methods only.~NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline and Week 24|APTS; Observed cases (OC)||Scores on a scale||Standard Deviation|Mean
94869|NCT00857233|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Baseline to Week 24|Completers from lead-in study 10158 were eligible for this open-label extension study. We analysed the All-patients-treated Set (APTS) - all patients who took at least one dose of investigational medicinal product (IMP)||participants|||Number
94870|NCT00857220|Secondary|Change From Baseline in Pediatric Quality of Life Scale|The SF-10™ Health Survey for Children is a 10-item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF-10 physical and psychosocial summary measures were scored such that higher scores indicated more favorable functioning. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||units on a scale||Standard Deviation|Mean
94871|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Minutes||Standard Deviation|Mean
94872|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Number of Awakenings||Standard Deviation|Mean
94873|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Minutes||Standard Deviation|Mean
94989|NCT00856661|Secondary|Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)|Please see outcomes measure one and two for detailed description of the scales|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Percentage of participants|||Number
94874|NCT00857220|Secondary|Change From Baseline in Conners’ Continuous Performance Test II (CCPT II)|The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners’ CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d’), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||percentage of score||Standard Deviation|Mean
94875|NCT00857220|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12|The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population||units on a scale||Standard Deviation|Mean
94876|NCT00857220|Secondary|Change From Baseline in Child Behavior Checklist (CBCL)|CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject’s age group and gender from the raw score and then dividing this by the standard deviation for the subject’s age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||units on a scale||Standard Deviation|Mean
94877|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Sleep Latency (SL)|Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||Minutes||Standard Deviation|Mean
94878|NCT00857220|Secondary|Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12|A 7-point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population||units on a scale||Standard Deviation|Mean
94879|NCT00857220|Secondary|Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population||score||Standard Deviation|Mean
94880|NCT00857220|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses|The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent).|12 Months|Intent to treat population||Subjects|||Number
94881|NCT00857220|Secondary|Neurologic Examinations||Day -14 to -1, and Months 1, 3, 6, 9, and 12||||||
94882|NCT00857220|Secondary|Physical Examinations||Day -30 to -1, and Months 1, 3, 6, 9, and 12||||||
94883|NCT00857220|Secondary|12 Lead ECG Parameters||Day -30 to -1, and Months 1 and 12||||||
94884|NCT00857220|Secondary|Orthostatic Effects||Day -14 to -1, Day 0, Week 2 (for treatment naive pts) , and Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12||||||
94885|NCT00857220|Secondary|Vital Sign Measurements||Day -14 to -1, Day 0, Week 2, and Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12||||||
94886|NCT00857220|Secondary|Clinical Laboratory Assessments||Day -30 to -1, Day 0, Week 2(for treatment naive pts), and Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12||||||
94887|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Participant Affected||12 Months (from the 1st dose to the end of study)|Intent to treat population||participants|||Number
94888|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Events||12 Months (from the 1st dose to the end of study)|Intent to treat population||Events|||Number
94889|NCT00857220|Primary|Overall Incidence of Adverse Events||12 Months (from the 1st dose to the end of study)|The intent-to-treat (ITT) population consisted of all enrolled subjects who had taken any study medication. One subject did not receive study medication||participants|||Number
94890|NCT00856986|Secondary|Hypoglycaemic Episodes Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 0-52|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis||episodes|||Number
94891|NCT00856986|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
94892|NCT00856986|Secondary|Adverse Events From Run-in (Week -12) to Week 52||Run-in (week -12) to Week 52|The Safety Analysis Set included all exposed subjects||events|||Number
94893|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmHg||Standard Error|Least Squares Mean
94894|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmHg||Standard Error|Least Squares Mean
94895|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 52|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm/cm||Standard Error|Least Squares Mean
94896|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 26|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm/cm||Standard Error|Least Squares Mean
94897|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 52||Week 0, week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm||Standard Error|Least Squares Mean
94898|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm||Standard Error|Least Squares Mean
94899|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||participants||Standard Error|Least Squares Mean
94900|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||cm||Standard Error|Least Squares Mean
94901|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (last observation carried forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||kg||Standard Error|Least Squares Mean
94902|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||kg||Standard Error|Least Squares Mean
94903|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94904|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94905|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94906|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94907|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 52.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
95118|NCT00855959|Secondary|Night-time Awakenings Due to Asthma Symptoms|Change in Night-time awakenings due to asthma symptoms from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||awakenings||Standard Deviation|Mean
94908|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 26.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94909|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94910|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94911|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||pmol/L||Standard Error|Least Squares Mean
94912|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||pmol/L||Standard Error|Least Squares Mean
94913|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 52||Week 0 (Randomisation), Week 52|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.|||||
94914|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 26||Week 0 (Randomisation), Week 26|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.|||||
94915|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94916|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94917|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94918|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||mmol/L||Standard Error|Least Squares Mean
94919|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)||Week 0, Week 52|The FAS (Full Analysis Set) includes LOCF of last observation before intensification for randomised Lira 1.8 mg treatment group subjects who were intensified.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
94920|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||Percentage point of total HbA1c||Standard Error|Least Squares Mean
94921|NCT00856986|Primary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.||Week 0 (Randomisation), week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)||Percentage point of total HbA1c||Standard Error|Least Squares Mean
94922|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Hours)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population||Hours||Standard Error|Least Squares Mean
94923|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Days)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population||Days||Standard Error|Least Squares Mean
94924|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective Number of Awakenings After Sleep Onset (NAASO)||Number of Awakenings||Standard Error|Least Squares Mean
94925|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).|The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children’s health-related quality of life. The scale asked questions about the child’s physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Pediatric Quality-of-Life Scale (Short Form-10)||units on a scale||Standard Error|Least Squares Mean
94926|NCT00856973|Secondary|Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score||Score||Standard Error|Least Squares Mean
94927|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.|The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score||units on a scale||Standard Error|Least Squares Mean
94928|NCT00856973|Secondary|Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population||Minutes||Standard Error|Least Squares Mean
94929|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|Actigraphy population which included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population||Minutes||Standard Error|Least Squares Mean
94930|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population||Minutes||Standard Error|Least Squares Mean
94931|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective Total Sleep Time||Minutes||Standard Error|Least Squares Mean
94932|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)|A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined Total Sleep Time||Minutes||Standard Error|Least Squares Mean
94944|NCT00856908|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment|||relative change in percent||95% Confidence Interval|Least Squares Mean
94933|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).|A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined of Awakenings After Sleep Onset||Number of Awakenings after sleep onse||Standard Error|Least Squares Mean
94934|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)|A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined sleep efficiency||percentage of SE||Standard Error|Least Squares Mean
94935|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective WASO||Minutes||Standard Error|Least Squares Mean
94936|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective SL (Sleep Latency)|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective sleep latency||Minutes||Standard Error|Least Squares Mean
94937|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.|The Conners’ 3 –Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners’ 3 –Parent Short Form was a subset of items from the full-length form, and included the Conners’ 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Conners’ ADHD Inattention rating scale||units on a scale||Standard Error|Least Squares Mean
94938|NCT00856973|Secondary|Change From Baseline in CGI-Child at Week 12|The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject’s assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Child||Units on a scale||Standard Error|Least Squares Mean
94939|NCT00856973|Secondary|Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12|The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject’s parent or caregiver and represented their assessment of severity and improvement in the subject’s symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Parent/Caregiver||Units on a scale||Standard Error|Least Squares Mean
94940|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)|A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Change from BL at Week 12 in WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 WASO||Minutes||Standard Error|Least Squares Mean
94941|NCT00856973|Primary|Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).|A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.|Baseline (Day 0) to Week 12|Intent to treat (ITT) population with both baseline and week 12 LPS. ITT refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.||minutes||Standard Error|Least Squares Mean
94942|NCT00856934|Secondary|Pain|Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.|Post operative day 5|||VAS Pain Score||Standard Deviation|Mean
94943|NCT00856934|Primary|Complete Wound Healing|Time required for complete epithelialization in days|Post operative day 5 and every other day thereafter|||Days||Standard Deviation|Mean
94945|NCT00856908|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100|Baseline is the day before first dose, end of treatment is last day of treatment|||relative change in percent||95% Confidence Interval|Least Squares Mean
94946|NCT00856908|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment|||relative change in percent||95% Confidence Interval|Least Squares Mean
94947|NCT00856908|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment|||L/h||Full Range|Mean
94948|NCT00856908|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the evening dose last day of treatment|||h||Full Range|Mean
94949|NCT00856908|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment|||h||Full Range|Median
94950|NCT00856908|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured following the morning dose last day of treatment|||umol/L||95% Confidence Interval|Geometric Mean
94951|NCT00856908|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment|||umol*h/L||95% Confidence Interval|Geometric Mean
94952|NCT00856908|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose|||Participants|||Number
94953|NCT00856908|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment|||kg||Standard Deviation|Mean
94954|NCT00856908|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||beats/min||Standard Deviation|Mean
94955|NCT00856908|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
94956|NCT00856908|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
94957|NCT00856843|Secondary|Mean Change in Serum Chemistry (mEq/L)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days|||mEq/L||Standard Deviation|Mean
94958|NCT00856843|Secondary|Mean Change in Serum Chemistry (mg/dL)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days|||mg/dL||Standard Deviation|Mean
94959|NCT00856843|Secondary|Subject Symptom Scores|Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).|2 days|||units on a scale||Standard Deviation|Mean
94960|NCT00856843|Secondary|Assessment of Residual Fluid - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94961|NCT00856843|Secondary|Assessment of Residual Fluid - Descending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94962|NCT00856843|Secondary|Assessment of Residual Fluid - Transverse Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94963|NCT00856843|Secondary|Assessment of Residual Fluid - Ascending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94964|NCT00856843|Secondary|Assessment of Residual Fluid - Cecum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94965|NCT00856843|Secondary|Assessment of Residual Stool - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94966|NCT00856843|Secondary|Assessment of Residual Stool - Descending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94967|NCT00856843|Secondary|Assessment of Residual Stool - Transverse Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94968|NCT00856843|Secondary|Assessment of Residual Stool - Ascending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94969|NCT00856843|Secondary|Assessment of Residual Stool - Cecum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days|||percentage of participants|||Number
94970|NCT00856843|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.|2 days|||percentage of participants|||Number
94971|NCT00856791|Secondary|Number of Adverse Events|The number of adverse events and their severity rating will be classified according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0.|6 months|||Adverse event|||Number
94972|NCT00856791|Primary|Progression Free Survival|Progression-free survival, defined as the number of days from the first day of study drug dosing to the day of documented disease progression or death, as assessed using RECIST (Response Evaluation Criteria in Solid Tumors) guidelines according to Therasse P, Arbuck SF, Eisenhauer EA, et al. (2000) J Natl Cancer Inst. 92:205-216. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 months|||day|||Number
94973|NCT00856778|Secondary|Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra||At implant|||percentage of responses|||Number
94974|NCT00856778|Secondary|Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies||At implant|||percentage of responses|||Number
94975|NCT00856778|Secondary|Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward||At implant|||percentage of responses|||Number
94976|NCT00856778|Secondary|Assess Change in Pad Use||12 months post-implant|||pads/24 hours||Standard Deviation|Mean
94977|NCT00856778|Secondary|Assess Change in Pad Use|Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.|Baseline|There are 97 subjects with outcome 9 (baseline pad use). Of the 98 subjects implanted, one is missing the baseline assessment of pad use.||pads/24 hours||Standard Deviation|Mean
94978|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant|||units on a scale||Standard Deviation|Mean
94979|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 7 (Urinary function at baseline). Of the 98 subjects implanted, 1 is missing the baseline Urinary Function assessment.||units on a scale||Standard Deviation|Mean
94980|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant|||units on a scale||Standard Deviation|Mean
94981|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 5 (Urinary bother at baseline). Of the 98 subjects implanted, 3 are missing the baseline Urinary Bother assessment.||units on a scale||Standard Deviation|Mean
94982|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|12 months post implant|There are 73 subjects with outcome 4 (ICIQ at 12 months). Of the 74 subjects with 12 months follow-up, 1 is missing the 12 month ICIQ assessment.||units on a scale - ICIQ Score||Standard Deviation|Mean
94983|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|Baseline|There are 95 subjects with outcome 3 (ICIQ at baseline). Of the 98 subjects implanted, 3 are missing the baseline ICIQ assessment.||units on a scale - ICIQ Score||Standard Deviation|Mean
94984|NCT00856778|Primary|Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).|"Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding very much better or much better."|12 months|"The study was not fully enrolled and therefore underpowered for the planned analyses.~There are 71 subjects with outcome 2 (pad weight endpoint). Of the 74 with 12 months follow-up, 3 are missing the pad weight improvement assessment."||% of subjects successful||95% Confidence Interval|Number
94985|NCT00856778|Primary|Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)|"Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding very much better or much better."|12 months post implant|The study was not fully enrolled and therefore underpowered for the planned analyses.||% of subjects successful||95% Confidence Interval|Number
94986|NCT00856739|Primary|Cartilage Thickness|Medial/lateral thickness ratio|baseline or first and only visit.|Overweight and obese were combined based on similarities found in literature. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.||mm/mm||Standard Deviation|Mean
94990|NCT00856661|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)|The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.|90 days|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Percentage of participants|||Number
94991|NCT00856661|Primary|Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)|The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient’s function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.||Percentage of participants|||Number
94992|NCT00856635|Secondary|To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.||6 months||||||
94993|NCT00856635|Primary|Retinal Nerve Fiber Layer Thickness at Baseline and Month 6|Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.|Baseline and Month 6|The modified ITT intent-to-treat (mITT) analysis set included all patients who had been randomized to the study, received at least one dose of study drug, had a baseline OCT evaluation, and had at least one non-missing post-baseline OCT evaluation.||µm||Standard Deviation|Mean
94994|NCT00856583|Secondary|Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure|The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
94995|NCT00856583|Secondary|Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease|The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
94996|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA|The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
94997|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC|"The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
94998|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
94999|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
95000|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
95001|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
95002|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|||participants|||Number
95003|NCT00856583|Primary|Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation|Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
95004|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
95005|NCT00856583|Primary|Number of Participants With All-cause Mortality|The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.||participants|||Number
95006|NCT00856557|Secondary|Rate of Contextual Planning|Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings|During initial patient recordings|||proportion of physician's patients||Standard Deviation|Mean
95007|NCT00856557|Secondary|Rate of Contextual Probing|Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.|During initial patient recordings|||proportion of physician's patients||Standard Deviation|Mean
95008|NCT00856557|Primary|Health Outcome Improvement Rate|A target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit.|After 9 months of the recorded visit|||proportion of physician's patients||Standard Deviation|Mean
95009|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
95010|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95011|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for given parameters for each group respectively.||hours per day||Standard Deviation|Mean
95012|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||hours per day||Standard Deviation|Mean
95013|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.||days||Standard Deviation|Mean
95014|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||days||Standard Deviation|Mean
95015|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure for given parameters for each group respectively.||events||Standard Deviation|Mean
95016|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||events||Standard Deviation|Mean
95017|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.||units on a scale||Standard Deviation|Mean
95018|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95019|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.||units on a scale||Standard Deviation|Mean
95020|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95021|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
95022|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Patient global assessment of arthritis: participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
95023|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
95024|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95025|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
95026|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95027|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
95028|NCT00856544|Secondary|Medical Outcome Study (MOS) Sleep Scale at Month 12|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
95029|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||participants|||Number
95030|NCT00856544|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95031|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for the measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95032|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. Here, 'n' is signifying those participants who were evaluable for the measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95033|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mm||Standard Deviation|Mean
95034|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
95035|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mm||Standard Deviation|Mean
95036|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
95037|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mm||Standard Deviation|Mean
95038|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
95039|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
95040|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
95041|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6, 12|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).|||||
95042|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).|||||
95043|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
95044|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95045|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
95046|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
95047|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
95048|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
95049|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
95050|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
95119|NCT00855959|Secondary|Use of Rescue Medication (Total)|Change in Use of rescue medication (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||puffs||Standard Deviation|Mean
95051|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
95052|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.||percentage of participants|||Number
95053|NCT00856544|Primary|Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
95054|NCT00856544|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95055|NCT00856544|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI) method.||percentage of participants|||Number
95056|NCT00856518|Primary|Swallow-related Quality of Life (SWAL-QOL)|The SWAL-QOL is a validated and standardized tool that measures burden; symptom status including pharyngeal, oral, and saliva; fear; and mental health subdomains. Responses are determined according to an ordinal scale where 1 equals a severe problem and 5 equals no problem. The SWAL-QOL provides an overall score as well as subscale scores. Subjects rate quality of life as follows (expressed as percentage of the possible perfect score): little to no impact (81% - 100%), mild impact (61% - 80%), moderate impact (41% - 60%), severe impact (21% - 40%), and profound impact (0% - 20%).|at baseline and after 5-week of EMST exercise|Out of the total 42 recruited study participants, ten either did not show up for the SWAL-QOL test or only partially answered the questionnaire. Thus, 32 remaining participants (n = 19 for EMST, and n = 13 for Sham) were reported.||percentage of possible perfect score||Standard Deviation|Mean
95057|NCT00856518|Primary|Penetration-Aspiration Scale Score|"The Penetration-Aspiration Scale (PAS) was used to measure swallow safety. PAS is an 8 point ordinal scale for quantification of penetration and aspiration. PAS measures the depth to which material enters the airway and if the material is expelled following penetration or aspiration. Categorical groupings of PAS scores include normal to mild (1-2), moderate (3-5) and severe (6-8, indicating that material has passed into the lower airway). These PAS scores may be useful in denoting clinically significant changes (e.g. moderate to mild) resulting from treatment or disease progression. The following table reports the percentage of participants (out of the respective total group participants in EMST and Sham) with changed PAS score of 1 point or more (improving or worsening) and without PAS score changes from pre- to post treatment. The data represent an exploratory quantification without statistical analysis."|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 8 failed to complete the PAS test either at baseline or post training testing. Therefore, 34 subjects were reported for the PAS test (n = 20 for EMST, n = 14 for sham).||percentage of group participants|||Number
95058|NCT00856518|Primary|Maximum Expiratory Pressure (MEP)|Expiratory pressure generating capacity assessed via handheld manometer.|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 6 withdrew following the baseline MEP testing, citing travel or loss of interest as the reason. Therefore, 36 subjects were reported for the MEP test (n = 20 for EMST, n = 16 for sham).||cm H2O||Standard Deviation|Mean
95059|NCT00856414|Secondary|Percentage of Patients Reporting Self-Perception of Age (SPA)|"Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were Looking younger, Looking current age, and Looking older. Results for each response are presented for Baseline and Day 14."|Baseline, Day 14|Intent to Treat defined as all patients who started the study||Percentage of patients|||Number
95060|NCT00856414|Secondary|Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score|Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.|Baseline, Day 14|Intent to Treat defined as all patients who started the study||Scores on a Scale||Standard Deviation|Mean
95061|NCT00856414|Secondary|Average Subject Assessment Score in Improvement of Appearance of Frown Lines|Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.|14 Days|Intent to Treat defined as all patients who started the study||Scores on a Scale||Standard Deviation|Mean
95062|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Subject Assessment|"The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study||Number of Days||Standard Deviation|Mean
95063|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Physician Assessment|"The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study||Number of Days||Standard Deviation|Mean
95064|NCT00856388|Secondary|3 yr Overall Survival|3 yr Overall Survival estimated using the Kaplan-Meier method.|Up to 4.5 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
95065|NCT00856388|Secondary|1 yr Extenstive Chronic GVHD|"1 yr Extensive Chronic GVHD~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to 4.5 years|All treated and eligible who survived to day 100 and were eligible to get chronic GVHD||percentage of participants||95% Confidence Interval|Number
95066|NCT00856388|Secondary|Acute GVHD Grade III-IV|"Acute GVHD grade III-IV~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to day 100|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
95067|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics."|Day 100|All treated and eligible patients, who were able to complete testing||percentage of participants|||Number
95068|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics."|Day 30|All treated and eligible patients, who were able to complete testing||percentage of participants|||Number
95069|NCT00856388|Secondary|Median Time to Platelet Engraftment|"Median Time to Platelet Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Day 100|All treated and eligible patients||Days||Full Range|Median
95070|NCT00856388|Secondary|Median Time to ANC Engraftment|"Median Time to ANC Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Days 30|All treated and eligible patients||Days||Full Range|Median
95071|NCT00856388|Primary|Day 100 TRM|Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.|First 100 days|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
95072|NCT00856349|Secondary|Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization|Characterization of shock reduction programming utilization by subject characteristics and geographical regions|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.||percentage of participants|||Number
95073|NCT00856349|Secondary|Barriers to Utilization of Shock Reduction Programming|Characterization of barriers to physician utilization of shock reduction programming|24 months follow-up visit|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||% of subjects not programmed to target|Participants||Number
95074|NCT00856349|Secondary|Actions Taken Following a Shock|Characterization of actions taken by the subject immediately following a device shock|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||percentage of subjects with shocks|Participants||Number
95075|NCT00856349|Secondary|Reasons for Inappropriate Shocks|Reasons for inappropriate shocks observed during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||percentage of inappropriate shocks|Participants||Number
95076|NCT00856349|Secondary|Lead Integrity Alert (LIA) Performance|Causes for LIA triggers reported during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.||percentage of subjects with LIA triggers|Participants||Number
95090|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.||titers||95% Confidence Interval|Geometric Mean
95077|NCT00856349|Primary|Change in Shock Reduction Programming Adoption|"Change in percentage of subjects programmed to evidence-based target from baseline (pre-TPR distribution) to last follow-up (post-TPR distribution).~Shock-reduction programming parameters:~LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.~SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.~VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.~VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.~Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.~PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds."|Overall study (20 months on average)|Subjects with paired baseline and follow-up programming data||percentage of participants|||Number
95078|NCT00856323|Secondary|Post-Exposure Prophylaxis Medication Adherence|Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).|28-days|35 participants initiated PEP||proportional medication adherence||Inter-Quartile Range|Median
95079|NCT00856323|Secondary|HIV-related Sexual Risk Behaviors in Previous 30 Days.|Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.|3-months after baseline|53 enrolled and 2 were withdrawn.||episodes||Standard Deviation|Mean
95080|NCT00856323|Secondary|Description of Incident STI Infections.|Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.|Baseline and 3-months|53 enrolled and 2 were withdrawn.||Proportion of Participants||Full Range|Mean
95081|NCT00856323|Primary|Self-reported Methamphetamine Use in Previous 30 Days.|Mean number of days (of the past 30) of methamphetamine use.|3-months after baseline|53 enrolled and 2 were withdrawn.||days||Standard Deviation|Mean
95082|NCT00856297|Secondary|Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.|28 days postvaccination|Analysis was done on safety population - subjects who received vaccination with MenACWY-CRM conjugate vaccine, provided post-baseline safety data and provide safety follow-up information for any period during the 28 day follow-up.||subjects|||Number
95083|NCT00856297|Secondary|Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator|Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.|Day 1 to 5 years|Analysis was done on safety follow-up population - subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases.||subjects|||Number
95084|NCT00856297|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events|Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.|Day 1 to Day 7|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||subjects|||Number
95085|NCT00856297|Secondary|Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.||titers||95% Confidence Interval|Geometric Mean
95086|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
95087|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine|Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|1 month post booster vaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
95088|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination|Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.||titers||95% Confidence Interval|Geometric Mean
95089|NCT00856297|Secondary|Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8|Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
95115|NCT00855959|Secondary|Number of Participants With Adverse Events (AEs)|Number of participants with AEs reported during the period on Pulmicort Respules|6 weeks|||Participants|||Number
95091|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
95092|NCT00856297|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.||percentages of subjects||95% Confidence Interval|Number
95093|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104|The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 104|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward was used (LOCF).||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
95094|NCT00856284|Secondary|Change From Baseline in Body Weight Over Time|LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.|Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, LOCF was used.||kg||Standard Error|Least Squares Mean
95095|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Percentage of participants with HbA1c ≤ 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
95096|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
95097|NCT00856284|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug who had a Baseline assessment and at least 1 post-baseline assessment for FPG. LOCF was used.||mg/dL||Standard Error|Least Squares Mean
95098|NCT00856284|Secondary|Change From Baseline in Glycosylated Hemoglobin at Other Time Points|The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.|Per-protocol set; LOCF was used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
95099|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 52|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward (LOCF) was used.||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
95100|NCT00856232|Primary|Time to Relief (Min)|Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache.|study duration|||Minutes||Standard Deviation|Mean
95101|NCT00856232|Secondary|Length of Stay in the Emergency Department(Min)|Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department.|Study duration|||Minutes||Standard Deviation|Mean
95102|NCT00856193|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)|According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.|Day 14|Safety Population||Participants|||Number
95116|NCT00855959|Secondary|Forced Vital Capacity (FVC)|Change in Forced Vital Capacity (FVC) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L||Standard Deviation|Mean
95103|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 12 hours-24 hours after drug administration on Day 14|Efficacy analysis set||Liters||Standard Error|Least Squares Mean
95104|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From day 1 to 0 -12 hours after drug administration on Day 14|Efficacy analysis set||Liters||Standard Error|Least Squares Mean
95105|NCT00856193|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 0-24 hours after drug administration on Day 14|Efficacy analysis set||Liters||Standard Error|Least Squares Mean
95106|NCT00856180|Secondary|Overall Survival (OS)|OS estimated using Kaplan-Meier methods is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median follow-up was 23 months in this study cohort.|The analysis dataset is comprised of all treated participants.||months||95% Confidence Interval|Median
95107|NCT00856180|Secondary|Progression-Free Survival (PFS)|PFS estimated using Kaplan-Meier methods is defined as the duration of time from the start of bevacizumab alone to documented disease progression (PD) requiring removal from the study or death. If participant ultimately received both bevacizumab and cyclophosphamide then it was the time until PD on both agents. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA-125 that rises to >/=2xULN documented, both requiring 2nd confirmation. Participants who were event-free were censored at the date of their last disease evaluation.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment and every 3 months in follow-up until PD, death or lost to follow-up. Median treatment duration was 7.5 months (range 0.7-20.7) and survival follow-up 23 months..|The analysis dataset is comprised of all treated participants.||months||95% Confidence Interval|Median
95108|NCT00856180|Secondary|Clinical Benefit Response Rate|Clinical benefit response rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.||proportion of participants||90% Confidence Interval|Number
95109|NCT00856180|Primary|Grade 3-5 Gastrointestinal Perforation|All grade 3-5 gastrointestinal perforation events based on CTCAEv3 as reported on case report forms.|Assessed each cycle/3 weeks throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.||proportion of participants||90% Confidence Interval|Number
95110|NCT00856180|Primary|Therapy Completion Rate|The therapy completion rate is defined as the proportion of participants who completed at least 3 months/4 cycles of therapy. Participants were treated until disease progression on the combination regimen or unacceptable toxicity. Clinical response was evaluated based on RECIST 1.0 criteria for measurable disease (MD) participants and Gynecologic Cancer Intergroup (GCIG) CA-125 (Rustin) criteria for non-MD participants. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA125 that rises to >/=2xULN documented, both requiring 2nd confirmation.|Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.||proportion of participants||80% Confidence Interval|Number
95111|NCT00856050|Primary|Progression Free Survival Rate at 12 Weeks|Data below are reported as progression free rate (%).The progression free survival rate at 12 weeks was 46% (90%CI, 29%-64%).|12 weeks|27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.||percentage of participants||90% Confidence Interval|Number
95112|NCT00856024|Secondary|Percent of Participants Who Achieved Early Virologic Response (EVR)|EVR was defined as HCV RNA negative after 12 weeks of treatment.|Week 12|Number of participants with data||Percent of participants||95% Confidence Interval|Number
95113|NCT00856024|Secondary|Percent of Participants Who Achieved Rapid Virologic Response (RVR)|RVR was defined as HCV RNA negative after 4 weeks of treatment.|Week 4|Number of participants with data||Percent of participants||95% Confidence Interval|Number
95114|NCT00856024|Primary|Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks|The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.|First 12 weeks of treatment|All enrolled participants||Percent of participants||95% Confidence Interval|Number
95120|NCT00855959|Secondary|Use of Rescue Medication (Night-time)|Change in Use of rescue medication (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||puffs||Standard Deviation|Mean
95121|NCT00855959|Secondary|Use of Rescue Medication (Daytime)|Change in Use of rescue medication (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||puffs||Standard Deviation|Mean
95122|NCT00855959|Secondary|Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||Scores on a scale||Standard Deviation|Mean
95123|NCT00855959|Secondary|Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||Scores on a scale||Standard Deviation|Mean
95124|NCT00855959|Secondary|Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||Scores on a scale||Standard Deviation|Mean
95125|NCT00855959|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in evening peak expiratory flow (ePEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L/min||Standard Deviation|Mean
95126|NCT00855959|Primary|Morning Peak Expiratory Flow (mPEF)|Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks|||L/min||Standard Deviation|Mean
95127|NCT00855933|Primary|Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale|"A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).~For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit."|4 weeks|||units on a scale||Standard Error|Mean
95128|NCT00855894|Secondary|Percentage of Patients With Disease Control (DC) at Day 56|DC was defined as a CR, a PR, or stable disease (SD) as determined by the investigator and based on CT using RECIST. A CR was defined as the disappearance of all target (TL) and non-target lesions (nTL). A PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline sum longest diameter, or the persistence of 1 or more nTLs and/or maintenance of a tumor marker level (TML) above normal limits. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (SSLD) since treatment started. For nTLs, SD was defined as the persistence of 1 or more lesions and/or maintenance of a TML above normal limits. PD was defined as ≥ 20% increase in the SLD of TLs, taking as reference the SSLD recorded since treatment started, the appearance of 1 or more new lesions, or the unequivocal progression of existing nTLs.|Baseline to Day 56|All 41 patients treated with erlotinib and pertuzumab.||Percentage of patients||95% Confidence Interval|Number
95129|NCT00855894|Secondary|Percentage of Patients With an Objective Response (OR)|OR was defined as a complete response (CR) or a partial response (PR) as determined by the investigator and based on computed tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) on 2 consecutive occasions at least 4 weeks apart. A complete response was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. A partial response was defined as ≥ 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or the persistence of 1 or more non-target lesions and/or the maintenance of a tumor marker level above the normal limits.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab.||Percentage of patients||95% Confidence Interval|Number
95130|NCT00855894|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of first dosing with pertuzumab and erlotinib until the date of patient death from any cause.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not died at the time of analysis for OS were censored at the date of last contact.||Months||95% Confidence Interval|Median
95131|NCT00855894|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dosing with pertuzumab and erlotinib to the first occurrence of disease progression (PD), as determined by the investigator and based on computed tomography using Response Evaluation Criteria in Solid Tumors (RECIST), or death from any cause, whichever comes first. PD was defined as ≥ 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started, the unequivocal progression of existing non-target lesions (non-TL), or the appearance of 1 or more new lesions. TLs were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as TLs. All other lesions (or sites of disease) were identified as non-TLs.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not progressed or died at the time of analysis for PFS were censored at the date of their last tumor assessment.||Months||95% Confidence Interval|Median
95144|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy||Baseline through Month 6 (or end of treatment)|FAS; LOCF. N= number of subjects with initial treatment administered as monotherapy.||percent of participants|||Number
95132|NCT00855894|Primary|Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups|The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.|Baseline to Day 56|All 41 patients treated with pertuzumab and erlotinib were evaluable for analysis. Patients with a missing Day 56 assessment were deemed non-responders. Tumor tissue samples were only available for 32 patients for EGFR mutation status analysis.||Percentage of patients||95% Confidence Interval|Number
95133|NCT00855868|Primary|Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.|Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.|28 d|||SUVR||Standard Deviation|Mean
95134|NCT00855842|Primary|Length of Medical Abortion|This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus|hours since the start of medical abortion|||hours||Standard Deviation|Mean
95135|NCT00855816|Primary|Change Scores for Criteria D Items on the CAPS Structured Clinical Interview|"Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment.~Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms.~Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms.~Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement)."|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
95136|NCT00855738|Secondary|Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit|Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).|Month 6|FAS; LOCF.||percent of participants|||Number
95137|NCT00855738|Secondary|Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy|Numerical assessment of change in total number of days hospitalized because of epilepsy during the study.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.||Days||Standard Deviation|Mean
95138|NCT00855738|Secondary|Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy|Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study.|Baseline to Month 6|FAS; LOCF. Costs involved in health and non-health resources needed during the study were not analyzed as planned with this endpoint. N=number of subjects with visits to a specialist because of epilepsy.||visits||Standard Deviation|Mean
95139|NCT00855738|Secondary|Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)|MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night.|Baseline, Month 6|FAS; LOCF.||percent of participants|||Number
95140|NCT00855738|Secondary|Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)|Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night).|Baseline to Month 6|FAS LOCF. Change from baseline in Optimal sleep is not shown as changes from baseline were only evaluated for continuous parameters. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
95141|NCT00855738|Secondary|Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)|Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 3, Month 6|FAS LOCF. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
95142|NCT00855738|Secondary|Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)|QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
95143|NCT00855738|Secondary|Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)|HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.||scores on scale||Standard Deviation|Mean
95146|NCT00855738|Secondary|Percent of Participants Reaching Monotherapy|Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study.|Baseline through Month 6 (or end of study)|FAS; LOCF. N=number of participants who started on bitherapy.||percent of partipants||95% Confidence Interval|Number
95147|NCT00855738|Secondary|Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)|Patient Global Impression of Change VAS: subject rated instrument to measure subject's change in overall status; range from 0 (much better) to 10 (much worse).|Baseline, Month 3, Month 6|FAS; LOCF. The scale for this endpoint was not collected and results were not analyzed as planned.||scores on scale||Standard Deviation|Mean
95148|NCT00855738|Secondary|Time to Discontinuation Due to Other Reasons||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to other reasons, the time to exit analyses was not performed.||days||Full Range|Median
95149|NCT00855738|Secondary|Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to safety, tolerability or compliance with treatment, the time to exit analysis was not performed.||days||Inter-Quartile Range|Median
95150|NCT00855738|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline, Month 3, Month 6|FAS; LOCF. As no participants discontinued due to lack of efficacy, the time to exit analysis was not performed.||days||Inter-Quartile Range|Median
95151|NCT00855738|Secondary|Percent of Participants Who Continued on Study Medication to Month 6|Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study.|Baseline to Month 6|FAS; LOCF.||percent of participants|||Number
95152|NCT00855738|Secondary|Time to First Seizure|Number of days to first seizure after baseline.|Baseline to Month 6 (or end of treatment)|FAS LOCF. N=number of subjects with evaluable data.||days||Standard Deviation|Mean
95153|NCT00855738|Secondary|Percent of Days Without Crisis During the Study|Crisis was defined as the total number of seizures during the study, the seizures at month 3 plus the seizures at month 6. The percent of days without crisis is number of days of study (date of last visit minus date of baseline visit) without crisis divided by number of days of study, multiplied by 100.|Baseline through Month 6 (or end of treatment)|The percentage of days without crisis during the study was not evaluable because a diary with the daily number of crises was not collected.||percentage of days|||Number
95154|NCT00855738|Secondary|Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS LOCF. N=number of subjects with evaluable data.||percent change||Inter-Quartile Range|Median
95155|NCT00855738|Secondary|Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.||percent of participants||95% Confidence Interval|Number
95156|NCT00855738|Secondary|Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment|Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit.|Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.||percent of participants||95% Confidence Interval|Number
95157|NCT00855738|Primary|Percent of Participants Classified as Responders|Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline).|Baseline, Month 3, Month 6 (last 3 months of treatment)|Full Analysis Set (FAS): intent-to-treat population = those who took at least 1 dose of study medication and had post-baseline data for at least 1 efficacy endpoint. Last Observation Carried Forward (LOCF) captures last 3 months of treatment for subjects who discontinued between Month 3 and Month 6 only. N=number of subjects with evaluable data.||percent of participants||95% Confidence Interval|Number
95158|NCT00855595|Other Pre-specified|Patient Opinion of Local Tolerability||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of Participants|||Number
95159|NCT00855595|Secondary|Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of participants|||Number
95160|NCT00855595|Secondary|Patient Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of participants|||Number
95161|NCT00855595|Secondary|Investigator Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.||Percentage of participants|||Number
95162|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 12|FAS||Percentage of participants|||Number
95163|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 8|FAS||Percentage of participants|||Number
95164|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 6|FAS||Percentage of participants|||Number
95165|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 4|FAS||Percentage of participants|||Number
95166|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 2|FAS||Percentage of participants|||Number
95167|NCT00855595|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)|Weeks 2, 4, 6, 8 and 12|FAS||Percentage of participants|||Number
95168|NCT00855595|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).|Weeks 2, 4, 6, 8 and 12|FAS||Percentage of participants|||Number
95169|NCT00855595|Secondary|Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)||Baseline and Weeks 2, 4, 6, 8 and 12|FAS||Percentage of participants|||Number
95170|NCT00855595|Secondary|Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2, 4, 6, 8 and 12|FAS||Percent of inflammatory lesions||Standard Deviation|Mean
95171|NCT00855595|Secondary|Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 4, 6, 8 and 12|FAS||Inflammatory lesions||Standard Deviation|Mean
95172|NCT00855595|Secondary|Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)||Week 2, 4, 6, 8 and 12|FAS||Inflammatory lesions||Standard Deviation|Mean
95173|NCT00855595|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2|Full analysis set (FAS)||Inflammatory lesions||Standard Deviation|Mean
95174|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint|Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||mL||Standard Deviation|Mean
95175|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint|Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||mL/sec||Standard Deviation|Mean
95176|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint|Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||mL/sec||Standard Deviation|Mean
95177|NCT00855582|Secondary|Erectile Function General Assessment Questionnaire (EF-GAQ)|The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.|12 weeks|Participants started study medication, and had non-missing data.||participants with yes response|||Number
95178|NCT00855582|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint|A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.||participants|||Number
95179|NCT00855582|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint|A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.||participants|||Number
95180|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
95181|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
95182|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
95183|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint|IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95184|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint|IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95185|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint|Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
95186|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint|Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
95187|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint|Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95188|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12|The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95189|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95190|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95209|NCT00855465|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Week 16|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
95191|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95192|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
95193|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95194|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95195|NCT00855582|Secondary|Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint|The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 2 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95196|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
95197|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of yes responses||Standard Error|Least Squares Mean
95198|NCT00855582|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on scale||Standard Error|Least Squares Mean
95210|NCT00855465|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Week 16|PR duration was evaluated as part of the 12-lead electrocardiogram. electrocardiograms (ECGs) were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
95199|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.||percentage of Yes responses||Standard Error|Least Squares Mean
95200|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95201|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95202|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95203|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
95204|NCT00855465|Other Pre-specified|Mean Ventricular Rate (VRmean) - Change From Baseline to Week 16|Ventricular rate was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||beats per minute (bpm)||Standard Deviation|Mean
95205|NCT00855465|Other Pre-specified|Mean RR Duration (RRmean) - Change From Baseline to Week 16|RR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
95206|NCT00855465|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Week 16|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
95207|NCT00855465|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Week 16|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
95208|NCT00855465|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Week 16|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.||ms||Standard Deviation|Mean
95211|NCT00855465|Other Pre-specified|Oxygen Saturation (SaO2) - Change From Baseline to Week 16|Oxygen saturation (SaO2) is measured as part of the capillary or arterial blood gas analysis. Normal blood oxygen saturation is considered 95-100 percent. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.||Percentage of oxygen saturation||Standard Deviation|Mean
95212|NCT00855465|Other Pre-specified|Arterial Partial Oxygen Pressure (PaO2) - Change From Baseline to Week 16|Arterial partial pressure of oxygen (PaO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.||mmHg||Standard Deviation|Mean
95213|NCT00855465|Other Pre-specified|Arterial Partial Pressure of Carbon Dioxide (PaCO2) - Change From Baseline to Week 16|Arterial partial pressure of carbon dioxide (PaCO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.||mmHg||Standard Deviation|Mean
95214|NCT00855465|Other Pre-specified|Triacylglycerol Lipase - Change From Baseline to Week 16|Triacylglycerol lipase is a standard clinical chemistry parameter. Normal range: 7 to 60 U/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
95215|NCT00855465|Other Pre-specified|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker. Normal range: 0.53 to 1.01 ng/mL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||ng/ml||Standard Deviation|Mean
95216|NCT00855465|Other Pre-specified|Urea (BUN) - Change From Baseline to Week 16|Urea (blood urea nitrogen, BUN) is a standard clinical chemistry parameter. Normal range: 4 to 25 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
95217|NCT00855465|Other Pre-specified|Urate - Change From Baseline to Week 16|Urate is a standard clinical chemistry parameter. Normal range: 4.0 to 8.5 mg/dL (males, 16-59 years), 3.4 to 8.7 mg/dL (males, >60 years) 2.5 to 7.5 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
95218|NCT00855465|Other Pre-specified|Potassium - Change From Baseline to Week 16|Potassium is a standard clinical chemistry parameter. Normal range: 3.5 to 5.3 mmol/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mmol/L||Standard Deviation|Mean
95219|NCT00855465|Other Pre-specified|Hematocrit - Change From Baseline to Week 16|Hematocrit is a standard clinical hematology parameter. Normal range: 40 to 52% (males), 36 to 46% (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||Volume percentage of red blood cells||Standard Deviation|Mean
95220|NCT00855465|Other Pre-specified|Hemoglobin - Change From Baseline to Week 16|Hemoglobin is a standard clinical hematology parameter. Normal range: 13.5 to 17.5 g/dL (males), 12.0 to 16.0 g/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||g/dL||Standard Deviation|Mean
95221|NCT00855465|Other Pre-specified|Neutrophils - Change From Baseline to Week 16|Neutrophils is a standard clinical hematology parameter. Normal range: 1.6 to 7.4*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^9 cells/L||Standard Deviation|Mean
95222|NCT00855465|Other Pre-specified|Lymphocytes - Change From Baseline to Week 16|Total lymphocytes is a standard clinical hematology parameter. Normal range: 1.0 to 4.0*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^9 cells/L||Standard Deviation|Mean
95223|NCT00855465|Other Pre-specified|Leukocytes (WBC) - Change From Baseline to Week 16|Leukocytes (white blood cells, WBC) is a standard clinical hematology parameter. Normal range: 4.0 to 10.7*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^9 cells/L||Standard Deviation|Mean
95224|NCT00855465|Other Pre-specified|Erythrocytes (RBC) - Change From Baseline to Week 16|Erythrocytes (red blood cells, RBC) is a standard clinical hematology parameter. Normal range: 4.6 to 5.8*10^12 cells/L (males), 4.1 to 5.2*10^12 cells/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||*10^12 cells/L||Standard Deviation|Mean
95225|NCT00855465|Other Pre-specified|Creatine Kinase (CK) - Change From Baseline to Week 16|Creatine Kinase is a standard clinical chemistry parameter. Normal range: 35 to 232 U/L (males), 26 to 145 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
95226|NCT00855465|Other Pre-specified|Creatinine Clearance - Change From Baseline to Week 16|Creatinine clearance is a standard clinical chemistry parameter. Normal range: 90 to 140 mL/min (males), 80 to 125 mL/min (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mL/min||Standard Deviation|Mean
95227|NCT00855465|Other Pre-specified|Creatinine - Change From Baseline to Week 16|Creatinine is a standard clinical chemistry parameter. Normal range: 0.25 to 1.20 mg/dL (males), 0.46 to 1.00 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
95228|NCT00855465|Other Pre-specified|Bilirubin - Change From Baseline to Week 16|Bilirubin is a standard clinical chemistry parameter. Normal range: 0.1 to 1.2 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||mg/dL||Standard Deviation|Mean
95229|NCT00855465|Other Pre-specified|Alkaline Phosphatase (AP) - Change From Baseline to Week 16|Alkaline phosphatase (AP) is a standard clinical chemistry parameter. Normal range: 40 to 129 U/L (males), 35 to 104 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
95230|NCT00855465|Other Pre-specified|Aspartate Aminotransferase (AST) - Change From Baseline to Week 16|Aspartate Aminotransferase (AST) is a standard clinical chemistry parameter. Normal range: 0 to 41 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
95231|NCT00855465|Other Pre-specified|Alanine Aminotransferase (ALT) - Change From Baseline to Week 16|Alanine Aminotransferase (ALT) is a standard clinical chemistry parameter. Normal range: 0 to 45 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.||U/L||Standard Deviation|Mean
95232|NCT00855465|Other Pre-specified|Heart Rate (HR) - Change From Baseline to Week 16|Heart rate (HR) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 50 -105 beats per minute (bpm) at rest.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.||Beats/min||Standard Deviation|Mean
95233|NCT00855465|Other Pre-specified|Diastolic Blood Pressure (DBP) - Change From Baseline to Week 16|Diastolic systemic arterial blood pressure (DBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: <= 110 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.||mmHg||Standard Deviation|Mean
95234|NCT00855465|Other Pre-specified|Systolic Blood Pressure (SBP) - Change From Baseline to Week 16|Systolic systemic arterial blood pressure (SBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 95 – 180 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.||mmHg||Standard Deviation|Mean
95235|NCT00855465|Other Pre-specified|Cardiac Index (CI) - Change From Baseline to Week 16|The cardiac index (CI) is a calculated hemodynamic parameter. CI is derived from the directly measured parameters cardiac output (CO), divided by the body surface area (BSA). BSA is a calculated parameter, using the subject’s height and weight in the DuBois formula. Formula: BSA = (W [kg]*0.425)*(H [cm]*0.725)*0.007184 (m^2)|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.~Only participants with a baseline and at least one post-baseline measurement were included in the analysis of CI."||L/min/m^2||Standard Deviation|Mean
95236|NCT00855465|Other Pre-specified|Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.~Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PAPmean."||mmHg||Standard Deviation|Mean
95323|NCT00854113|Primary|AUC 0-t|Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||ng*hr/ml||Standard Deviation|Mean
95237|NCT00855465|Other Pre-specified|All Caused Mortality|"All cause mortality (including cardiovascular mortality) was one component of the composite endpoint time to clinical worsening."|At visit 6 (week 16)|Intent to Treat (ITT) - a randomized subject was valid for ITT analyses if at least one dose of study medication was administered.||Participants|||Number
95238|NCT00855465|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.||Scores on a scale||Standard Deviation|Mean
95239|NCT00855465|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.||Scores on a scale||Standard Deviation|Mean
95240|NCT00855465|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Scores on a scale||Standard Deviation|Mean
95241|NCT00855465|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH.|At week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Percentage of participants|||Number
95242|NCT00855465|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.||Percentage of Participants|||Number
95243|NCT00855465|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.||pg/mL||Standard Deviation|Mean
95244|NCT00855465|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.||dyn*s*cm^-5||Standard Deviation|Mean
95245|NCT00855465|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Meters||Standard Deviation|Mean
95246|NCT00855439|Other Pre-specified|Intra-epidermal Nerve Fiber Density|Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.|12 months|Subset of study population||nerve fibers per mm of skin||Standard Deviation|Mean
95247|NCT00855439|Secondary|Cardiac Autonomic Neuropathy|resting heart rate as marker of autonomic function at rest|18 month|||beats per minute||Standard Deviation|Mean
95248|NCT00855439|Secondary|Cardiac Autonomic Neuropathy (CAN)|Group differences in E/I ratio, a measure of cardiac autonomic function.|18 months|||unit-less measure||Standard Deviation|Mean
95249|NCT00855439|Primary|Confirmed Clinical Neuropathy (CCN)|CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude < 5 μV and a conduction velocity < 40 m/sec for the sural nerve and an amplitude < 2.5 μV and a conduction velocity < 40 m/sec for the peroneal nerve).|18 Months|||participants|||Number
95250|NCT00855309|Primary|Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline||24 hours|||participants|||Number
95324|NCT00854113|Primary|Tmax|Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||hour||Full Range|Median
95251|NCT00855218|Secondary|Tumor Response – Investigator Assessment|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Participants|||Number
95252|NCT00855218|Secondary|Tumor Response - Independent Radiological Review|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Participants|||Number
95253|NCT00855218|Secondary|Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)|Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
95254|NCT00855218|Secondary|Time to Untreatable Progression (TTUP)|Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
95255|NCT00855218|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
95256|NCT00855218|Primary|Time to Progression (TTP) – Independent Radiological Review (Primary Analysis)|TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)||Days||95% Confidence Interval|Median
95257|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)||Percent||95% Confidence Interval|Least Squares Mean
95258|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)||Percent||95% Confidence Interval|Least Squares Mean
95259|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)||Percent||95% Confidence Interval|Least Squares Mean
95260|NCT00855166|Secondary|Proportion of Participants With Body Weight Decrease ≥5%|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
95261|NCT00855166|Secondary|Adjusted Mean Change in Body Fat Mass|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
95262|NCT00855166|Secondary|Adjusted Mean Change in Waist Circumference|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||cm||95% Confidence Interval|Least Squares Mean
95263|NCT00855166|Primary|Adjusted Mean Change in Total Body Weight|To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
95317|NCT00854308|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients.||months||95% Confidence Interval|Number
95318|NCT00854113|Primary|VZ/F|Pharmacokinetic results. Apparent volume of distribution|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||Liters||Standard Deviation|Mean
95264|NCT00855062|Secondary|24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score|"The outcome is the total CES-D score at week 24 - the total CES-D score at baseline.~The total CES-D score is based on 20 CES-D items, such as I was bothered by things that usually don't bother me and I did not feel like eating, my appetite was poor. Patients were asked to answer each item by 4 scales: (1) Rarely, (2) Sometimes, (3) Occasionally, and (4) Most of the time. After 4 negative items were multiplied by -1, the total CES-D score is a simple sum of all items.~The min and Max are 0 and 60, respectively. Higher scores indicate more severe depressive symptoms."|At baseline and week 24|The analysis includes participants with CES-D scores at baseline and week 24.||scores on a scale||Standard Deviation|Mean
95265|NCT00855062|Secondary|24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed)|The outcome is the HIV RNA plasma viral loads (Log10 transformed) at week 24 - the viral loads (Log10 transformed) at baseline.|At baseline and week 24|The analysis includes participants with HIV RNA viral loads at baseline and week 24.||copies/mL||Inter-Quartile Range|Median
95266|NCT00855062|Secondary|24-week Change of Instrumental Activities of Daily Living|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The analysis includes participants with IADL scores at baseline and week 24.||percentage of participants|||Number
95267|NCT00855062|Secondary|48-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 48 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 48|This analysis used the participants with CD4 cell counts at baseline and week 48.||cells/mm^3||Standard Deviation|Mean
95268|NCT00855062|Secondary|24-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 24 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 24|This analysis used the participants with CD4 cell counts at baseline and week 24.||cells/mm^3||Standard Deviation|Mean
95269|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms|The outcome is the time of first Grade ≥ 2 toxicity and/or sign and symptoms from treatment initiation up to 48 weeks. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks|This analysis includes every randomized participants. A total of 22 minocycline and 21 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 48 weeks.||participants with an event|||Number
95270|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms.|The outcome is the time to first Grade ≥ 2 toxicity and/or sign and symptoms from study treatment initiation up to week 24. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24|This analysis includes every randomized participants. A total of 21 minocycline and 20 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 24 weeks||participants with an event|||Number
95271|NCT00855062|Secondary|24-week Change of Karnofsky Performance Score|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|This analysis includes the participants with Karnofsky performance score at baseline and week 24.||percentage of participants|||Number
95272|NCT00855062|Secondary|24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The descriptive statistics were based on observed data. Since all participants reported there were no change in the MSK score at week 24, no statistical test was conducted.||participants|||Number
95273|NCT00855062|Primary|24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)|"The U NP Sum is defined as the average of z scores for 9 neuropsychological test subcomponents in the neuropsychological test battery (i.e. the average of norm-adjusted (z) scores for Grooved Pegboard Dominant Hand, Grooved Pegboard Non-dominant Hand, Color Trails 1, Color Trails 2, Symbol Digit, WHO-UCLA Verbal Learning test Trial 5, WHO-UCLA Verbal Learning test delayed recall, Digit Span forward and Digit Span backward). The outcome is defined as U NP Sum at week 24 - U NP Sum at baseline."|At baseline and week 24|The descriptive statistics are based on per protocol analysis. For the statistical analysis, ITT analysis was used and the missing U NP Sums at week 24 were imputed using a multiple regression imputation method. The number of participants analyzed for the ITT analysis was 73 (36 for Minocycline and 37 for Placebo).||z-score||Standard Deviation|Mean
95274|NCT00854906|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire|The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used in dry eye studies. The OSDI Scale ranges from 0= Normal to 100= Severe. Subcategories include problems--all of the time, most of the time, half of the time,and none of the time.|1 week|By comparing the KTBUT and the FTBUT to the Ocular Surface Disease Index (OSDI) questionnaire score of each participant, we will be able to evaluate the difference in tear break up time using these items. The OSDI was given once before the participant's KTBUT and FTBUT was measured.||participants||Standard Deviation|Mean
95275|NCT00854906|Primary|Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)|This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.|1 day|The number of participants for analysis was determined if each participant met all of the study protocol's inclusion and exclusion criteria. KTBUT and FTBUT were measured on all study participants.||time in seconds|Participants|Standard Deviation|Mean
95276|NCT00854724|Primary|Amount of Alcohol Consumed||During a 90 minute drinking session|||Number of drinks consumed||Standard Error|Mean
95277|NCT00854620|Primary|Time-to-progression (TTP)||12 months|||months||Full Range|Median
95278|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
95279|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95280|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
95281|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95282|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
95283|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95284|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
95285|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95306|NCT00854373|Primary|Mean Fertilization Proportion (2PN/Oocytes Collected)|Number of normally fertilized oocytes (2PNs) divided by the total number of oocytes collected (i.e., not just the number of inseminated MII oocytes). This accounted for the possibility of both an enhanced oocyte maturation and improved fertilization of the mature oocytes. This also permitted inclusion of both IVF and intracytoplasmic sperm injection (ICSI) cycles in a way that allowed for evaluation of collective fertilization rates (i.e., typically, the denominator in IVF in calculating fertilization rate is all eggs collected, but in ICSI it is calculated using only the number of MII oocytes injected).|24 hours after IVF or intracytoplasmic sperm injection (ICSI)|Intention to treat||percentage of oocytes||Standard Deviation|Mean
95286|NCT00854607|Secondary|Average of the Z-scores of %CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
95287|NCT00854607|Secondary|Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
95288|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.||Average Z-Score||Standard Deviation|Mean
95289|NCT00854607|Secondary|Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95290|NCT00854607|Secondary|Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95291|NCT00854607|Secondary|Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95292|NCT00854607|Primary|Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-β-D-glucan (βDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall standard deviation (SD). The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and whose clinical outcome was determined at Week 6.||Average Z-Score||Standard Deviation|Mean
95319|NCT00854113|Primary|CL/F|Pharmacokinetics results. Apparent oral clearance|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||L/hr||Standard Deviation|Mean
95320|NCT00854113|Primary|Terminal Rate Constant.|Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||L/hr||Standard Deviation|Mean
95293|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the attitude scale of the survey.||units on a scale||Standard Deviation|Mean
95294|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:~Instruct patients on home glucose monitoring~Teach foot care~Teach insulin administration~Instruct patients about diet~Help patients make changes in their diets that you have recommended~Instruct patients about regular exercise~Help patients make changes in their exercise habits that you have recommended~Identify candidates for long-acting insulin~Interpret glucose patterns~Adjust insulin in insulin-treated patients with poor glycemic control~Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin~Manage patients with poor glycemic control~Initiate insulin therapy (NPH or insulin glargine and aspart)~Apply principles of diabetes care in a team setting~Averages of provider efficacy were calculated across all activities."|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the ability items of the survey.||units on a scale||Standard Deviation|Mean
95295|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:~Instruct patients on home glucose monitoring~Teach foot care~Teach insulin administration~Instruct patients about diet~Help patients make changes in their diets that you have recommended~Instruct patients about regular exercise~Help patients make changes in their exercise habits that you have recommended~Identify candidates for long-acting insulin~Interpret glucose patterns~Adjust insulin in insulin-treated patients with poor glycemic control~Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin~Manage patients with poor glycemic control~Initiate insulin therapy (NPH or insulin glargine and aspart)~Apply principles of diabetes care in a team setting~Averages of provider efficacy were calculated across all activities."|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 55 intervention arm providers completed the ability items of the survey.||units on a scale||Standard Deviation|Mean
95296|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 53 intervention arm providers complete the attitude scale of the survey.||units on a scale||Standard Deviation|Mean
95297|NCT00854581|Primary|Number of Patients Who Achieved Complete Response or Partial Response According to Molecular Response Criteria|To determine the effect of valproic acid therapy on persistent clonal disease in patients in complete or stable partial remission.|3, 6 and 12 months.|||participants|||Number
95298|NCT00854581|Secondary|Overall Survival|Overall survival (OS) will be measured from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up will be censored at date of last contact (censored observation).|Measured from the date of initiation of study treatment until date of death from any cause.||||||
95299|NCT00854581|Secondary|Failure-free Survival|Failure-free survival (FFS) will be measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time will be censored at the last documented date of failure-free status.|measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause.||||||
95300|NCT00854581|Primary|To Investigate Whether AZT Functions as an Inhibitor of NF-kB in Vivo by Analyzing Serially Collected Leukemic Samples During the First 48 Hours of Treatment With AZT Only.||3, 6 and 12 months.||||||
95301|NCT00854581|Primary|To Analyze Clones From Patients Who Relapse to Determine Whether Antiviral Escape is Associated With Expression of IRF-4, c-Rel or Other Molecular Events (p53, p16 Mutations) Including Expansion of Novel Clones.||3, 6 and 12 months.||||||
95302|NCT00854581|Primary|Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy||3, 6 and 12 months.||||||
95303|NCT00854581|Primary|To Investigate Whether the Lack of IRF-4 and/or c-Rel is Associated With Response (CR or PR) to Zidovudine (AZT) and IFN Alpha-2b Therapy.||3, 6 and 12 months.||||||
95304|NCT00854373|Secondary|Pregnancy|Fetal heart motion by transvaginal ultrasound|6 weeks after embryo transfer|||percentage of participants|||Number
95305|NCT00854373|Secondary|Mature Oocyte Recovery Rate|Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary.|36 hours after hCG trigger|||percentage of follicles|||Number
95316|NCT00854308|Secondary|Percentage of Participants With Objective Response|"Objective response (partial and complete response as determined using RECIST 1.0).~Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.~Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients.||Percentage of participants||95% Confidence Interval|Number
95307|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping).~Total non-nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The non-nasal population included only those participants with adequate non-nasal symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 6 or greater for the 24-hour reflective non-nasal symptom score, over the last 7 days of the Run-in Period.||units on a scale||Standard Error|Least Squares Mean
95308|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping).~The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The ocular population included only those participants with adequate ocular symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 4 or greater for the 24-hour reflective ocular symptom score, over the last 7 days of the Run-in Period.||units on a scale||Standard Error|Least Squares Mean
95309|NCT00854360|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates symptom improvement.|Baseline and Week 2|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.||units on a scale||Standard Error|Least Squares Mean
95310|NCT00854360|Secondary|Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
95311|NCT00854360|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to the assessment, twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
95312|NCT00854360|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The Intent-to-treat population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
95313|NCT00854308|Secondary|Duration of Overall Response||Date of initial response until date of progression or death on study. (Up to 20 months)|All randomized intent-to-treat patients. Analyses of duration of response were not performed because of the small number of patients with objective responses.|||||
95314|NCT00854308|Primary|Progression-free Survival in Patients With Met Diagnostic-Positive Tumors|"Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry.~PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment)."|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-Positive tumors.||months||95% Confidence Interval|Median
95315|NCT00854308|Secondary|Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors|"Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry.~Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.~Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-positive tumors.||Percentage of participants||95% Confidence Interval|Number
95325|NCT00854113|Primary|Cmax|Pharmacokinetics results. Cmax -Maximum plasma drug concentration|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days|||ng/ml||Standard Deviation|Mean
95326|NCT00854087|Primary|Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|"Efficacy of Fuzheng Huayu treatment was assessed through the change in liver fibrosis stage from the assessment before (pre) and after (post) study drug. The liver fibrosis staging system used was the Ishak scale. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.~Fibrosis improved was defined as a lower post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 3 or lower.~Fibrosis did not change was defined as having the same Ishak score before and after study drug assessments e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 4.~Fibrosis worsened was defined as a higher post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 5 or higher."|Baseline to Week 48|Participants who at least took one dose of study drug (Fuzheng Huayu or Placebo), were more than 80% compliant with study drug and had a pre and post study drug biopsy with an evaluable Ishak fibrosis score. Participants had ALT <300 and a BMI <40.||participants|||Number
95327|NCT00854087|Primary|Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.|Baseline to Week 60||||||
95328|NCT00853970|Secondary|Pain Free|Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.|Day 1|Last observation carried forward (LOCF) Analysis, Intent to treat (ITT) Population||participants|||Number
95329|NCT00853970|Primary|Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15 (Primary Endpoint)|Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population||participants|||Number
95330|NCT00853957|Secondary|Percentage of Patients With Peripheral Edema by Visit|Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.|8 weeks|Full Analysis Set||Percentage of participants|||Number
95331|NCT00853957|Secondary|Change From Baseline in MSSBP at Week 1 and 4|Compare the change from baseline in MSSBP at week 1 and 4|Baseline, 1 and 4 weeks|Full analysis set, Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
95332|NCT00853957|Secondary|Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)|Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set||Percentage of participants|||Number
95333|NCT00853957|Secondary|Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)|Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set||Percentage of participants|||Number
95334|NCT00853957|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
95335|NCT00853957|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
95336|NCT00853905|Secondary|Ocular Hypotensive Medications||Ocular medications will be documented during the 1 day, 1 week, 1 month, 3 month, and or 6 month post-operative period||||||
95337|NCT00853905|Secondary|A Patient Comfort Questionnaire|Dry Eye Scores were lower in the treatment group at 1 month|Patients will be quiered at 1 day, 1 week, 1 month, 3 month and 6 month post-op visit||||||
95338|NCT00853905|Secondary|Bleb Morphology Graded by Indiana Bleb Appearance Grading Scale (IBAGS) and the Moorfields Bleb Grading System (MBGS)|Bleb appearance is grading using the Moorfields bleb grading system IBAGS; anterior segment slit lamp photos were also done|IBAGS assessed at 1 day, 1 week, 1 month, 3 month and 6 month post-op visits; Moorfields Bleb Grading will be done at 1 month, 3 month, and 6 month post-op visits||||||
95339|NCT00853905|Secondary|A Kowa FM-500 Flare Meter is Used to Measure Inflammation in the Anterior Chamber|Anterior chamber inflammation measurement is taken 10 times using the Kowa FM-500 flare meter per eye|Data collected 1 month, 3 month and 6 month post-op visits||||||
95340|NCT00853905|Primary|Intraocular Pressure (IOP)|patient failed the study if IOP was less than 5mmhg for starting IOP or less than a 20% decrease in IOP|Data collected Baseline (before Surgery), 1 day, 1week, 1 month, 3 month and 6 month post-op visits|||mm Hg||95% Confidence Interval|Mean
95341|NCT00853840|Secondary|Number of Subjects With Postural Hypotension|Postural (orthostatic) hypotension defined as 1) decrease in standing-supine diastolic blood pressure (BP) greater than or equal to 10 mm Hg; 2) decrease in standing-supine systolic BP greater than or equal to 20 mm Hg; or 3) standing systolic BP less than 90 mm Hg. Assessed at Period 1 and Period 2 BP measurement timepoints post maraviroc dose.|Period 1 and Period 2 (up to 8 days)|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||participants|||Number
95342|NCT00853840|Secondary|Postural Changes in Pulse Rate|Postural change calculated as position 1 (standing) value minus position 2 (supine) value. Baseline was the average of the 3 predose measurements at each period. Means of Replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||beats per minute (bpm)||Standard Deviation|Mean
95343|NCT00853840|Secondary|Postural Changes in Systolic and Diastolic Blood Pressure|Postural change calculated as position 1 (standing) value minus the position 2 (supine) value. Baseline was the average of 3 predose measurements at each period. Means of replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||mm Hg||Standard Deviation|Mean
95344|NCT00853840|Secondary|Standing and Supine Pulse Rate|Supine pulse rate measurement was taken after subject rested for 5 minutes supine. Subject sat for 2 minutes, then stood for 2 minutes and standing measurement taken. Duplicate supine and standing pulse rate measurements taken per protocol. Average of duplicate measurements calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||beats per minute (bpm)||Standard Error|Least Squares Mean
95345|NCT00853840|Primary|Standing and Supine Systolic and Diastolic Blood Pressure (BP)|Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.||mm Hg||Standard Error|Least Squares Mean
95346|NCT00853827|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.|104 weeks|Safety - All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received||Number of patients|||Number
95347|NCT00853827|Secondary|Patients That Demonstrated Evidence of Atheroma Regression|Atheroma regression is defined as change from baseline to endpoint in PAV <0 .|Baseline to endpoint (104 weeks)|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization||Participants|||Number
95348|NCT00853827|Secondary|Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS|Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.||mm^3||Standard Error|Least Squares Mean
95349|NCT00853827|Primary|Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment|Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.||percentage of baseline||Standard Error|Least Squares Mean
95350|NCT00853762|Primary|Number of Subjects With Positive Neutralizing Antibody (NAb)||Baseline, Week 12 and 36|Appropriate method/test was not established to identify the positive neutralizing antibodies for atacicept. Hence, this outcome measure was not assessed.|||||
95351|NCT00853762|Secondary|Pharmacogenetics/Pharmacogenomics Analysis|"Gene expression profiling and gene polymorphism identification were to be used to identify putative markers for response to treatment.~Genome-wide gene polymorphism characterization by genome-wide scan.~Targeted gene polymorphism identification of B-Lymphocyte Stimulator (BLyS) , APRIL, (receptor for B cell activating factor of the tumor necrosis factor [TNF] family) BAFF-R, (Transmembrane Activator) TACI and (B Cell Maturation Antigen) BCMA and HLA-DRB1 by direct genotyping or sequencing ."|Day 1 and Week 36|Genetic/genomic analysis was not performed as the trial was terminated early.|||||
95352|NCT00853762|Secondary|Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.|Levels of free APRIL and free BLyS: Free APRIL serum samples were to be analyzed by using a validated enzyme-linked immunosorbent assay (ELISA) with limits of detection of 0.3125 nanogram per milliliter (ng/mL) for free APRIL and free BlyS serum samples were analysed using a validated ELISA with limits of detection of 1.56 ng/mL.|Baseline, Week 12 and 36|This outcome measure was not assessed due to lack of a valid assay for measuring BLyS and APRIL.|||||
95353|NCT00853762|Secondary|Concentrations of Free and Total Atacicept||Baseline and Week 12|This outcome measure was not assessed due to lack of a valid assay during the usable time period of the samples.|||||
95354|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject||Baseline, Week 12 and Week 24|||Cubic millimeter||Standard Deviation|Mean
95355|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject||Baseline, Week 12 and 24|Intent-to-treat (ITT) population included all randomized subjects. “n” signifies the number of evaluable subjects for this outcome measure.||Number of lesions per subject||Standard Deviation|Mean
95356|NCT00853762|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies number of evaluable subjects for this outcome measure."||z-score||Standard Deviation|Mean
95357|NCT00853762|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies (total number of subjects analyzed) the number of evaluable subjects for this outcome measure."||Units on a scale||Standard Deviation|Mean
95358|NCT00853762|Secondary|Number of Subjects With Clinical Attacks/Relapses|"A clinical attack/relapse was defined as the fulfillment of all the following criteria:~Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours.~Absence of fever or known infection (fever with temperature (axillary, orally, or intra-auriculary) > 37.5°C/99.5 °Fahrenheit).~Objective neurological impairment, correlating with the subject’s reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated."|Baseline up to Week 24|Intent-to-treat (ITT) population included all randomized subjects.||Subjects|||Number
95359|NCT00853762|Primary|Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels|Number of subjects with shifts from normal Grade (Grade 0) at Baseline to worse value at post-baseline (Grade 1 to Grade 4) according to the following criteria: IgA Grade 0: greater than or equal to (>=) lower limit normal (LLN) 0.7 gram per liter (g/L); Grade 1: less than (<) LLN - 0.5 g/L, Grade 2: <0.5g/L -0.3 g/L, Grade 3: <0.3 g/L -0.1 g/L, Grade 4: < 0.1 g/L; IgG Grade 0: >= LLN (7 g/L), Grade 1: < LLN - 5 g/L, Grade 2: <5g/L -4 g/L, Grade 3: <4 g/L -3 g/L and Grade 4: < 3 g/L; IgM Grade 0: >= LLN (0.4 g/L), Grade 1: < LLN - 0.3 g/L, Grade 2: <0.3 g/L -0.2 g/L, Grade 3: <0.2 g/L -0.1 g/L, and Grade 4: < 0.1 g/L are presented in this outcome measure.|Baseline up to Week 36|Intent-to-treat (ITT) population included all randomized subjects.||Subjects|||Number
95360|NCT00853762|Primary|Change From Baseline in Electrocardiogram (ECGs)||Baseline, Week 12 and 36|No summary tables were prepared for ECG parameters, and ECG data were not formally analyzed. However, a qualitative assessment of ECG morphology and rhythm was made by the Investigator and recorded in the electronic case report form (eCRF). ECG abnormalities considered significant by the investigator were reported as AEs.|||||
95361|NCT00853762|Primary|Change From Baseline in Vital Signs: Temperature||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.||Degree Celsius||Standard Deviation|Mean
95362|NCT00853762|Primary|Change From Baseline in Vital Signs: Pulse Rate||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.||beats per minute (beats/min)||Standard Deviation|Mean
95363|NCT00853762|Primary|Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure (systolic and diastolic) was measured after at least 3 minutes resting, with the subject in the seated position.|Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.||millimeter of mercury (mmHg)||Standard Deviation|Mean
95364|NCT00853762|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity|TEAEs were defined as AEs with a start date after or on the date of the first DB treatment injection in ATAMS Extension and that occurred anytime after treatment discontinuation, or up to the day before first Rebif® rescue medication injection in ATAMS Extension. A serious TEAE was an AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE severity was graded as per Qualitative Toxicity Scale. Local injection site reactions (injection site: pain, redness, itching and swelling) throughout ATAMS Extension, starting after the first trial medication administration. If the subject experienced 1 or more of the above injection site symptoms, these were reported with the AE verbatim term “injection site reaction”. For all randomized subjects, there was an option of rescue treatment with Rebif® for 1 year beginning with the first injection of Rebif®).|From the first dose of study drug administration up to Week 24|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study.||Subjects|||Number
95385|NCT00853658|Secondary|All Cause Death|Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.|up to end of study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations||participants|||Number
95365|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination|Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 4|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic||Percentage of participants|||Number
95366|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Particpants may have been represented in more than 1 category.|Day 1 through Day 4|Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic||Percentage of participants|||Number
95367|NCT00853749|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all particpants with available data for the specified blood draw.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
95368|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (OPA)|Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype.||GMT||95% Confidence Interval|Geometric Mean
95369|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (Avidity Assay)|Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).|Day 28|Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype.||AI||95% Confidence Interval|Geometric Mean
95370|NCT00853749|Primary|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination|Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of participants||95% Confidence Interval|Number
95371|NCT00853749|Primary|Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination|Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of participants||95% Confidence Interval|Number
95372|NCT00853723|Secondary|Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)|"Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP < or = 0.86 then TMP/GFR = TRP x P phos if TRP > 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos~U= urine, P = plasma"|Baseline, Day 15, Day 30, Day 60, Day 90|||mg/dl||Standard Error|Mean
95373|NCT00853723|Secondary|Fractional Excretion of Calcium|(Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)|Baseline, Day 15, Day 30, Day 60, Day 90|||% excreted||Standard Error|Mean
95374|NCT00853723|Secondary|1,25 Vitamin D||Baseline, Day 15, Day 30, Day 60, Day 90|||pg/ml||Standard Error|Mean
95375|NCT00853723|Secondary|24 Hour Urine Calcium||90 days|||mg/gm creatinine||Standard Error|Mean
95376|NCT00853723|Secondary|Serum Phosphorous||Baseline, Day 15, Day 30, Day 60, Day 90|||mg/dl||Standard Error|Mean
95377|NCT00853723|Secondary|Total Serum Calcium (mg/dl)||Baseline, Day 15, Day 30, Day 60, Day 90|||mg/dl||Standard Error|Mean
95378|NCT00853723|Secondary|Changes in Bone Mineral Density of the Distal 1/3 Radius.||90 days|||Percent change from baseline||Standard Error|Mean
95379|NCT00853723|Secondary|Changes in Bone Mineral Density of the Forearm.||90 days|||Percent change from baseline||Standard Error|Mean
95380|NCT00853723|Secondary|Changes in Bone Mineral Density of the Femoral Neck.||90 days|||Percent change from baseline||Standard Error|Mean
95381|NCT00853723|Secondary|Changes in Bone Mineral Density of the Total Hip.||90 days|||Percent change from baseline||Standard Error|Mean
95382|NCT00853723|Primary|Carboxy-terminal Telopeptides of Collagen-1 (CTX)||Baseline, Day 15, Day 30, Day 60, Day 90|||percentage change from baseline||Standard Error|Mean
95383|NCT00853723|Secondary|Changes in Bone Mineral Density of the Lumbar Spine.||90 days|||Percent change from baseline||Standard Error|Mean
95384|NCT00853723|Primary|Procallagen-1 Amino-terminal Peptide (P1NP)||Baseline, Day 15, Day 30, Day 60, Day 90|||percentage change from baseline||Standard Error|Mean
95386|NCT00853658|Secondary|Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 12|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.||KCCQ Score||Standard Error|Least Squares Mean
95387|NCT00853658|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to End of Study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.||participants|||Number
95388|NCT00853606|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.|Baseline, End of Treatment|Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.||scores on a scale||Standard Deviation|Mean
95389|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents to Intent-to-Treat population.||percentage of sexual attempts||Standard Deviation|Mean
95390|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Deviation|Mean
95391|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing|Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.|6 month|Subjects with bipolar configuration electrode R-wave amplitude at 6 month.||mV||Standard Deviation|Mean
95392|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance|Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with bipolar configuration pacing impedance at 6 month||Ohms||Standard Deviation|Mean
95393|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold|Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.|6 month|Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month||Volts||Standard Deviation|Mean
95394|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing|Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.|During implant procedure.|Subjects with ring electrode R-wave amplitude at implant||mV||Standard Deviation|Mean
95395|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance|Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with ring electrode pacing impedance at 6 month||Ohms||Standard Deviation|Mean
95396|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold|Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.|6 month|Subjects with ring electrode threshold captured at 0.5 ms at 6 month||Volts||Standard Deviation|Mean
95397|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing|Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.|6 month|Subjects with tip electrode R-wave amplitude at 6 month||mV||Standard Deviation|Mean
95398|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance|Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with tip electrode pacing impedance at 6 month||Ohms||Standard Deviation|Mean
95539|NCT00852930|Secondary|Quality of Life|The Functional Assessment of Chronic Illness Therapy that measure quality of life -total score. Range of scores could be 0 to 148. Higher score represents higher quality of life.|Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.|||total score||Inter-Quartile Range|Median
95399|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold|Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.|6 month|Subjects with tip electrode threshold captured at 0.5 ms at 6 month||Volts||Standard Deviation|Mean
95400|NCT00853593|Secondary|Efficacy: Bipolar Voltage Threshold|Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds [ms]) is less than or equal to 4.0 Volts.|1 month|Subjects that were implanted with a Model 4396 lead and completed the 1 month visit||Volts||Standard Deviation|Mean
95401|NCT00853593|Secondary|Assessment of Lead Handling Characteristics Reported as Acceptable|Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.|During implant procedure.|Subjects who underwent a Model 4396 left ventricular lead implant attempt.||participants|||Number
95402|NCT00853593|Secondary|Total Operation Time|Total operation time was defined as time from initial incision to final closure.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.||minutes||Standard Deviation|Mean
95403|NCT00853593|Secondary|Model 4396 Lead Placement Time|Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's LV Lead placement time was permanently missing and a study deviation was reported.||minutes||Standard Deviation|Mean
95404|NCT00853593|Secondary|Fluoroscopy Time|The total time the fluoroscope was imaging (not including biplane fluoroscopy time).|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's standard fluoroscopy time was not collected and a study deviation was reported.||minutes||Standard Deviation|Mean
95405|NCT00853593|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.||minutes||Standard Deviation|Mean
95406|NCT00853593|Secondary|Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead|A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.|During implant procedure.|Subjects who underwent an implant attempt.||participants|||Number
95407|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead|A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.|During implant procedure.|Subjects who underwent an implant attempt.||participants|||Number
95408|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation|A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.|During implant procedure.|Subjects with successful CS cannulation after an implant attempt.||participants|||Number
95409|NCT00853593|Secondary|Subjects Successfully Implanted With Model 4396 Lead|A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.|During implant procedure.|Subjects who underwent Model 4396 LV implant attempt.||participants|||Number
95410|NCT00853593|Primary|Efficacy: Proximal Ring Voltage Threshold|Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.|Three months|Subjects with ring electrode threshold captured at 0.5 ms at 3-month||Volts||Standard Deviation|Mean
95411|NCT00853593|Primary|Efficacy: Distal Tip Electrode Voltage Threshold|Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds [ms]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.|One month|Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.||Volts||Standard Deviation|Mean
95412|NCT00853593|Primary|Safety (Subjects Without a Model 4396 Lead Related Complication)|A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).|One month|Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.||participants|||Number
95413|NCT00853567|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated|||||
95414|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95520|NCT00853021|Other Pre-specified|CD25+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
95415|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95416|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
95417|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||hours per day||Standard Deviation|Mean
95418|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||days||Standard Deviation|Mean
95419|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||days||Standard Deviation|Mean
95420|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||events||Standard Deviation|Mean
95421|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||events||Standard Deviation|Mean
95422|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95423|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95424|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95425|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95426|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
95427|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95428|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.||participants|||Number
95429|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||participants|||Number
95430|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95440|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
95431|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95432|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
95433|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95434|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95435|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95436|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
95437|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
95438|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
95439|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
95441|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
95442|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95443|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95444|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.|||||
95445|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.|||||
95446|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95447|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95448|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95449|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
95521|NCT00853021|Other Pre-specified|CD4+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
95450|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
95451|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
95452|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
95453|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
95454|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
95455|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.||percentage of participants|||Number
95456|NCT00853385|Primary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).||percentage of participants|||Number
95457|NCT00853385|Primary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
96214|NCT00847405|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
95458|NCT00853385|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20% improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.||percentage of participants|||Number
95459|NCT00853333|Primary|Pain Rating Change|"Mechanical Slide Algometer (www.decisionaidsonline.com), Range: No Pain Sensation (1) to  Most Intense Sensation Imaginable (10) 10 point scale.~Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention."|Sedation|||units on a scale||Standard Error|Least Squares Mean
95460|NCT00853242|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.||mg/dL||Standard Deviation|Mean
95461|NCT00853242|Secondary|Change From Baseline in Total Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.||mg/dL||Standard Deviation|Mean
95462|NCT00853242|Secondary|Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22||Baseline, Day 22|Full Analysis Set.||mg^2/dL^2||Standard Deviation|Mean
95463|NCT00853242|Secondary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)||Baseline, Day 22|FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure <= 3 days after date of last study drug.||mg/dL||Standard Deviation|Mean
95464|NCT00853242|Primary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)||Baseline, Day 22|Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (<=) 3 days after date of last study drug.||mg/dL||Standard Deviation|Mean
95465|NCT00853151|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) at 3-Week and 6-Month Endpoints|Values from repeated measures include fixed categorical effects of treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate of baseline HOMA derived beta-cell function (HOMA-B). HOMA=index of function of cells that make insulin. Indices derived from fasting glucose and insulin concentrations. HOMA is measurement reflecting fasting plasma glucose and insulin. Has no defined minimum/maximum value. HOMA-B values generated from table reflecting values derived from Oxford HOMA2 model calculator. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline HOMA value.||units on a scale||Standard Error|Least Squares Mean
95466|NCT00853151|Secondary|Change From Baseline in Fasting Insulin at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline Fasting Insulin. Fasting insulin is the Mixed-Meal Tolerance Test (MMTT) insulin assessment at timepoint 0, where available, otherwise it is the assessment taken from the fasting laboratory measurements obtained during the clinic visit. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline fasting insulin value.||microinternational units/milliliter||Standard Error|Least Squares Mean
95467|NCT00853151|Secondary|Number of Participants With Adjudicated and Confirmed Deaths and Non-Fatal Cardiovascular (CV) Events at Any Timepoint|The protocol specified that deaths and nonfatal cardiovascular (CV) adverse events (AEs) be adjudicated by independent physician(s) with cardiology or neurology experience. The CV AEs to be adjudicated were protocol-defined as myocardial infarction (MI), hospitalization for unstable angina or for heart failure, coronary interventions (coronary artery bypass graft or percutaneous coronary intervention [PCI]) and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack (TIA). 3 CV events were adjudicated by an external independent adjudication committee.|Baseline (Week -1) through 6 months|All participants who received at least 1 dose of TT223 or its placebo.||participants|||Number
95468|NCT00853151|Secondary|Number of Participants With Hypoglycemia|The number of participants for whom low blood glucose was reported. Hypoglycemia ≥1 events including: severe hypoglycemia(glucose <50mg/dL, unable to treat self or recover after treatment); documented symptomatic (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms); asymptomatic (glucose ≤70mg/dL no symptoms); probable symptomatic (glucose missing, adrenergic or neuroglycopenic symptoms); relative (glucose >70mg/dL, adrenergic or neuroglycopenic symptoms), nocturnal (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms between bedtime/waking).|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||participants|||Number
95469|NCT00853151|Secondary|Percentage of Participants With Hypoglycemia|Calculation of frequency of low glucose for time period. Hypoglycemia≥1 events: severe<50mg/dL, unable to treat self/recover after treatment; documented symptomatic≤70mg/dL, adrenergic/neuroglycopenic symptoms; asymptomatic≤70mg/dL no symptoms; probable symptomatic glucose missing, adrenergic/neuroglycopenic symptoms; relative>70mg/dL, adrenergic/neuroglycopenic symptoms, nocturnal≤70mg/dL, adrenergic/neuroglycopenic symptoms between bedtime/waking. Because number participants who experienced hypoglycemia was low for every arm (1-3/arm) did not model percentage participants with hypoglycemia.|Baseline (Week -1) through 6 months|Because the number of hypoglycemia events were too low to model the percentage of hypoglycemia, zero participants were analyzed.||percentage of participants|||Number
95522|NCT00853021|Other Pre-specified|IL-8 Levels|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
95470|NCT00853151|Secondary|Percentage of Participants With 2-Fold Elevation of Lipase and/or Amylase at Any Timepoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline amylase.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||percentage of participants|||Number
95471|NCT00853151|Secondary|Change From Baseline in Amylase at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline amylase value.||units/liter (U/L)||Standard Error|Least Squares Mean
95472|NCT00853151|Secondary|Change From Baseline in Lipase at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline serum lipase. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||units per liter (U/L)||Standard Error|Least Squares Mean
95473|NCT00853151|Secondary|Change From Baseline in 7-Point Profile, Self-Monitored Blood Glucose (SMBG) at 4-Week and 6-Month Endpoints|7-point average=average of mean value of all time points for visit (premorning meal, 2-hours postmorning meal, premidday meal, 2-hours postmidday meal, preevening meal, 2-hours postevening meal, bedtime). Values represent mean of values collected same time on 3 separate days within week prior to visit. Values from repeated measures included fixed categorical effects: treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate baseline <7-point average glucose value or time point presented. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value for the variable being analyzed.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
95474|NCT00853151|Secondary|7-point Profile, Self-Monitored Blood Glucose (SMBG) Values|The 7-point average is the average of the mean value of all time points for the visit. Time points included pre-morning meal, 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and bedtime.|Baseline (Week -1), 4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
95475|NCT00853151|Secondary|Change From Baseline in Waist Circumference at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||centimeters (cm)||Standard Deviation|Mean
95476|NCT00853151|Secondary|Visual Analog Scale (VAS) for Nausea|The Visual Analog Scale (VAS) is a continuous measure for degree of nausea and/or gastrointestinal discomfort. Each of these scales is 100 millimeters (mm) in length with 0 meaning no nausea at all and 100 meaning extreme nausea. Participants record self-assessment of how much nausea they have had, from 0 to 100, during the time interval indicated.|4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.||units on a scale||Standard Deviation|Mean
95477|NCT00853151|Secondary|Pharmacokinetics (PKs) of LY2428757, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug. LY2428757 concentrations were collected at only a single timepoint; therefore, pharmacokinetic (PK) parameters could not be modeled from the data. Analysis was not done due to insufficient time points being collected.|0 (pre-dose)|Analyses were not conducted due to insufficient time points being collected; zero participants were analyzed.||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
95478|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|Apparent volume of distribution during the terminal phase after extra-vascular administration (Vz/F) is the apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-state after extra-vascular administration (Vss/F) is the apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
95479|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
95480|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Area Under Concentration Versus Time From Zero to Infinity (AUC[0-infinity])|Area under concentration versus time curve from zero to infinity (AUC[0-infinity]). Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
95481|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Half Life (t1/2)|Half-life (t1/2) is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Geometric Coefficient of Variation|Geometric Mean
95482|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Full Range|Geometric Mean
95483|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
95484|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|volume of distribution during the terminal phase after extra-vascular administration (Vz/F): Apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-State after extra-vascular administration (Vss/F): Apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
95485|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-Vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
95486|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Area Under the Curve (AUC)(0-infinity)|Area under the curve (AUC)(0-infinity) = area under concentration versus time from zero to infinity. Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
95487|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Half-Life (t1/2) Associated With the Terminal Rate Constant (λz) in Non-Compartmental Analysis|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Geometric Coefficient of Variation|Geometric Mean
95488|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
95489|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||hours||Full Range|Geometric Mean
95490|NCT00853151|Secondary|Number of Participants With Antibodies to TT223|Participants who were positive for antibodies for TT223.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||participants|||Number
95491|NCT00853151|Secondary|Number of Participants With Antibodies to LY2428757|Participants who were positive for antibodies to LY2428757.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.||participants|||Number
95492|NCT00853151|Secondary|Mean Change From Baseline in Weight at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline weight. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline weight value.||kilograms (kg)||Standard Error|Least Squares Mean
95493|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Adjusted for Baseline HbA1c, C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance, Duration of Diabetes, and Weight at 3-Week, 4-Week, 2-Month, 3.5-Month, 5-Month, and 6-Month Endpoints|The subgroup analyses for fasting blood glucose (FBG) (adjusted for baseline glycosylated hemoglobin [HbA1c]), C-peptide level, homeostasis model assessment of insulin resistance (HOMA), duration of diabetes, and weight) were not performed due to the lack of statistically significant findings in the subgroup analysis for the glycosylated hemoglobin (HbA1c) analyses. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 4 weeks, 2 months, 3.5 months, 5 months, 6 months|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
95509|NCT00853099|Secondary|Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)|"Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
95494|NCT00853151|Secondary|Change From Baseline in MMTT Response (Postprandial Glucose, Glucose AUC, Insulin/c-Peptide Secretory Response, HOMA, GLP-1, Glucagon) Adjusted for Baseline HbA1c, C-Peptide Level, HOMA, Duration of Diabetes, Weight at Week 0, 3, Month 3.5, 6 Endpoints|Subgroup analyses for mixed meal tolerance test (MMTT) response (adjusted for baseline glycosylated hemoglobin (HbA1c), C-peptide level, Homeostasis Model Assessment of Insulin Resistance (HOMA), duration of diabetes, weight) not performed due to lack of statistically significant findings in subgroup analysis for HbA1c analyses. HOMA was not done for mixed meal tolerance test (MMTT) because it is not calculated from the mixed meal tolerance test (MMTT). It is reported separately as a secondary outcome measure. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 3 weeks, 3.5 months, 6 months|Because the subgroup analyses for MMTT response were not conducted due to the lack of statistically significant findings in the subgroup analysis for the HbA1c analyses, zero participants were analyzed.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
95495|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) Adjusted for Baseline Glycosylated Hemoglobin (HbA1c), C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance (HOMA), Duration of Diabetes, and Body Mass Index (BMI) at 6-Month Endpoint|HbA1c adjusted: baseline HbA1c (<8%,≥8%); C-peptide level (normal, elevated); HOMA (<baseline median,≥baseline median); duration diabetes (<3,3-10,>10 years); BMI (<30,≥30). BMI estimates body fat based on weight/height squared. HOMA: index of function of cells that make insulin/insulin resistance. Indices derived from fasting glucose and insulin concentrations. LS means adjusted for treatment, baseline therapy, visit, treatment-by-visit, subgroup, subgroup-by-treatment, subgroup-by-visit, subgroup-by-treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline value.||percent glucosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
95496|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline fasting blood glucose (FBG). Fasting blood glucose (FBG) is the mixed meal tolerance test (MMTT) glucose assessment at time point 0, where available, otherwise it is the assessment taken from the chemistry panel. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline fasting blood glucose (FBG) value.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
95497|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Post-Prandial Glucose at 3-Week and 6-Month Endpoints|Standardized MMTT to assess changes in function of cells that make insulin (pancreatic beta cells). Glucose measured at 2-hour timepoint during MMTT reflects glucose values in response to meal. Change in postprandial glucose calculated based on difference of 2-hour postprandial glucose at endpoint compared to baseline. Larger changes from baseline represent a greater postprandial glucose compared to 2-hour timepoint prior to treatment. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit and time point being assessed.||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
95498|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon-like Peptide-1 (GLP-1) Area Under the Cure (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under plasma glucagon-like peptide-1 (GLP-1) concentration versus time curve calculated using linear-trapezoidal method. Area under the curve (AUC) for glucagon-like peptide-1 (GLP-1) represents the AUC of GLP-1 values when plotted over time. Larger AUC values represent a greater average GLP-1 value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
95499|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under the plasma glucagon concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucagon represents the AUC of glucagon values when are plotted over time. Larger area under the curve (AUC) values represent a greater average glucagon value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
95500|NCT00853151|Secondary|Change From Baseline in Mixed Meal Tolerance Test (MMTT) Response - Ratio of Insulin Area Under the Curve (AUC)/Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Mixed meal tolerance test (MMTT) to assess changes in function of cells making insulin. AUCinsulin/AUCglucose ratio: index of insulin secretion. Larger values reflect greater secretion adjusted for glucose in response to meal. Area under insulin concentration versus time curve and area under plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for insulin and glucose represents AUC of values plotted over time. LS means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat population (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline AUC insulin/AUC glucose value. Reporting is on the 131 participants who received either TT223 or its placebo and reflects data only from the treatment and follow-up phases of the study.||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
95501|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - C-Peptide Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents area under the curve (AUC) of C-peptide values when plotted over time. Larger area under the curve (AUC) values represent a greater average C-peptide value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit interaction. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline C-peptide area under the curve (AUC) value.||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
95502|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed-meal tolerance test (MMTT) used to assess changes in function of cells that make insulin (pancreatic beta cell function). Area under the plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for glucose represents area under curve of values when plotted over time. Larger area under the curve values represent greater average glucose value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline value and at least 1 post-baseline glucose area under the curve (AUC) value.||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
95503|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 4-Week Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
95504|NCT00853151|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 6-Month Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
95505|NCT00853099|Secondary|Number of Participants With Adverse Events During the Adalimumab Treatment Period|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|221 weeks|The safety analysis set.||participants|||Number
95506|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 52|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|52 weeks|The safety analysis set.||participants|||Number
95507|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 8|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|8 weeks|The Safety Analysis Set includes all participants who received at least one dose of study medication.||participants|||Number
95508|NCT00853099|Secondary|Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders|An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
95538|NCT00852930|Primary|Whole Arm Volume Difference|Whole arm measurement to determine volume.|Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.|||Whole Arm Volume % Difference||Inter-Quartile Range|Median
95510|NCT00853099|Secondary|Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)|"The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
95511|NCT00853099|Secondary|Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)|"Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
95512|NCT00853099|Secondary|Percentage of Participants With Mucosal Healing|"Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52.~The endoscopy subscore ranges from zero to three as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
95513|NCT00853099|Secondary|Percentage of Participants With a Clinical Response|"A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1.~The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore, based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore, based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
95514|NCT00853099|Secondary|Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scores from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.||percentage of participants|||Number
95515|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 52|Full analysis set. Non-responder imputation (NRI) was used, where all missing remission values and values after the start of rescue treatment were considered as non-remission.||percentage of participants|||Number
95516|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 8 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 8|The full analysis set includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication. Non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission.||percentage of participants|||Number
95517|NCT00853073|Secondary|Improvement in Filtering Blebs Morphology||6 months||||||
95518|NCT00853073|Primary|Intraocular Pressure (IOP)|mmHg (milimeters of mercury)|6 months|||mmHg (milimeters of mercury)||Full Range|Mean
95519|NCT00853021|Other Pre-specified|T-helper Cells (Type 1,2)|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
95523|NCT00853021|Other Pre-specified|CD303+ Plasmacytoid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)||||||
95524|NCT00853021|Other Pre-specified|Peripheral Blood CD1c+ Myeloid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), Beginning and end of cycle 1 (day 1, 57)||||||
95525|NCT00853021|Secondary|Percentage of Patients With Neutropenia|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of neutropenia|From start of treatment to 30 days after treatment|||percentage of participants|||Number
95526|NCT00853021|Secondary|Percentage of Patients With Constitutional Adverse Events|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of fatigue and fever/chills|From start of treatment to 30 days after treatment|||percentage of patients|||Number
95527|NCT00853021|Secondary|Objective Response Rate (Complete and Partial Response)|To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.|4 weeks after treatment|||percentage of participants|||Number
95528|NCT00853021|Primary|Progression Free Survival|Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.|From baseline (day -14) to disease progression (reported at 2 years)|||months||95% Confidence Interval|Median
95529|NCT00852995|Secondary|Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks – the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.||Days to Closure||95% Confidence Interval|Median
95530|NCT00852995|Secondary|Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.||units on a scale||Standard Deviation|Mean
95531|NCT00852995|Secondary|Percentage of Participants With Complete Wound Closure at Each Visit|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test||percentage of participants|||Number
95532|NCT00852995|Secondary|Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13|The area of each subject’s target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.|Over the 12 week treatment period or until the wound closed, which ever occurred first.|The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo.||Responders|||Number
95533|NCT00852995|Secondary|Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P < 0.05.||Percent change||Standard Error|Least Squares Mean
95534|NCT00852995|Secondary|Kaplan-Meier Probability of Non-Closure|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks – the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.||Probability of Non-Closure|||Number
95535|NCT00852995|Primary|The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P < 0.05.||percent change||Standard Deviation|Mean
95536|NCT00852969|Secondary|Change in HDL-C From Baseline to 14 Weeks||14 weeks since baseline|||mg/dl||95% Confidence Interval|Mean
95537|NCT00852969|Primary|Change in the Flow Mediated Dilation From Baseline|Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks|14 weeks since baseline|||absolute percent change||95% Confidence Interval|Mean
95540|NCT00852930|Secondary|Symptoms|Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.|Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.|Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome.||symptoms||Inter-Quartile Range|Median
95541|NCT00852930|Primary|LDex Change-|Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.|Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.|LDex units.||LDex||Inter-Quartile Range|Median
95542|NCT00852917|Secondary|Dropout Rate|Reasons for withdrawal from the trial were collected|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.||percentage of participants|||Number
95543|NCT00852917|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference in WOMAC Physical||Standard Deviation|Mean
95544|NCT00852917|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient’s overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||participants|||Number
95545|NCT00852917|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||mm||Standard Deviation|Mean
95546|NCT00852917|Secondary|Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no difficulty (0mm) to extreme difficulty (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||Percentage difference in WOMAC Physical||Standard Deviation|Mean
95547|NCT00852917|Secondary|Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||Percentage difference in WOMAC Pain||Standard Deviation|Mean
95548|NCT00852917|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference in WOMAC Pain||Standard Deviation|Mean
95549|NCT00852917|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)||participants|||Number
95550|NCT00852761|Secondary|Dermatology Life Quality Index (DLQI) Categories|Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.|Days 3, 8, 15|||participants|||Number
95551|NCT00852761|Secondary|Total Dermatology Life Quality Index (DLQI) Score|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
95552|NCT00852761|Secondary|Dermatology Quality of Life - Treatment|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
95597|NCT00851721|Secondary|Abnormal Prothrombin Fragment F 1.2 Assay Results|The normal reference range of values for prothrombin fragment F 1.2 is 69-229 pmol/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||pmol/L||Inter-Quartile Range|Median
95553|NCT00852761|Secondary|Dermatology Quality of Life - Personal Relationships|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
95554|NCT00852761|Secondary|Dermatology Quality of Life - Work and School|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
95555|NCT00852761|Secondary|Dermatology Quality of Life - Leisure|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
95556|NCT00852761|Secondary|Dermatology Quality of Life - Daily Activities|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
95557|NCT00852761|Secondary|Dermatology Quality of Life - Symptoms and Feelings|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)||units on a scale||Standard Deviation|Mean
95558|NCT00852761|Secondary|Median Change in Psoriasis Grading Scale|Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline, Days 3, 8, 15|ITT||unites on a scale||Inter-Quartile Range|Median
95559|NCT00852761|Secondary|At Least a 3 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95560|NCT00852761|Secondary|At Least a 2 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95561|NCT00852761|Secondary|At Least 1 Grade Improvement in Subject’s Global Assessment|Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject’s Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95562|NCT00852761|Secondary|At Least a 3 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95563|NCT00852761|Secondary|At Least a 2 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95564|NCT00852761|Secondary|At Least 1 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95565|NCT00852761|Secondary|At Least a 3 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95566|NCT00852761|Secondary|At Least a 2 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)||participants|||Number
95567|NCT00852761|Secondary|At Least 1 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3 and 8|Intent to treat (ITT)||participants|||Number
98684|NCT00827073|Primary|Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs||(1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)|||bacterial spceies||Standard Deviation|Mean
95568|NCT00852761|Primary|At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)|Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline to day 15|ITT||participants|||Number
95569|NCT00851786|Secondary|VZV-specific Cellular Immune Responses by Intracellular Cytokine Staining and/or ELISPOT Assays in the First 40 Subjects Entering in Each CD4 Stratum at the Opening of Stage II||Within 6 weeks following one or two doses of ZOSTAVAX||||||
95570|NCT00851786|Secondary|VZV Antibodies as Measured by gpELISA|VZV antibody titer measured by gpELISA after one or two doses of ZOSTAVAX/placebo|Within 6 weeks following one or two doses of ZOSTAVAX|Subjects with both baseline gpELISA result and at least one post vaccination gpELISA result available||log gpELISA antibody titer||Standard Deviation|Mean
95571|NCT00851786|Primary|Number of Participants With Composite Safety Endpoint of the Occurrence of Serious Adverse Events (SAEs) or Division of AIDS (DAIDS) Grade 3 and 4 Signs and Symptoms, Excluding SAEs Related to Trauma|Although the study was designed as a randomized trial, it was not powered to detect safety related differences between treatment arms. The safety of ZOSTAVAX was determined by comparing the number of subjects from the active arm who experienced safety endpoint to the number from a pre-specified decision rule, which was calculated based on a similar population and calibrated using the number of safety endpoints observed from the placebo arm. The pre-specified decision rule is that ZOSTAVAX would be considered to have acceptable safety if no more than 18 subjects experience a study-defined composite safety endpoint.|During the 6 week study period after receipt of any dose of ZOSTAVAX|Subjects who received at least one dose of study vaccine/placebo||participants|||Number
95572|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Pediatrics <12 Years Old|"General pain was assessed using the children’s VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). Assessments were done at the screening, 6 months, and termination visits.~Scores on the children's VAS scale are presented as:~No Pain~Mild Pain~Moderate pain~Severe pain~Very severe pain~Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account.~Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||participants|||Number
95573|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Adults and Adolescents ≥12 Years Old|"General pain was assessed using a VAS pain scale at screening, 6 months, and at termination. Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account. For the pain scale, a higher number indicates worse pain.~The visual analog scale ranges from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). A positive change from baseline indicates improvement.~Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants ≥12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
95574|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Child's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <16 years old, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
95575|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Parent's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - for all participants <16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
95598|NCT00851721|Secondary|Abnormal Fibrin Degradation Products (FDP) Assay Results|The normal reference range of values for FDP is 0-5 ug/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||ug/mL||Inter-Quartile Range|Median
95576|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Adults (Haem-A-QoL) ≥ 16 Years Old|"The Haem-A-QoL instrument has been developed and used in Hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & Leisure (S&L), School & Work (W&S), Dealing with Hemophilia (Dealing), Family Planning (FP), Feeling, Relationships (R'ships), Treatment, View, and Outlook for the Future (Future). A Haem-A-QoL Total Score (Total) was also calculated. For the Haem-A-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haem-A-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset for all participants ≥ 16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
95577|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL): EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Index Scores|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.~EQ-5D Index scores based on EQ-5D questionnaire were calculated for participants ≥14 years of age, at screening, 6 months, and at termination visit. Changes in scores at 6 months and termination were also calculated.~A relatively higher score represents better quality of life."|12 months ± 14 days|HRQoL Intent-to-Treat Analysis Dataset - comprised of all participants ≥14 years of age who were randomized, had any available assessments at any available study visits (baseline, 6- month, and 12-month) as defined in the protocol||Scores on a scale||Standard Deviation|Mean
95578|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Number of Days Lost (Work or School)||12 months ± 14 days|Pharmacoeconomic Analysis Set||Days||Standard Deviation|Mean
95579|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set||Days||Standard Deviation|Mean
95580|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set||Days||Standard Deviation|Mean
95581|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Physician’s Office Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set||Physician's office visits||Standard Deviation|Mean
95582|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Emergency Room Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set||Emergency room visits||Standard Deviation|Mean
95583|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set||hospitalizations||Standard Deviation|Mean
95584|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set||hospitalizations||Standard Deviation|Mean
95585|NCT00851721|Secondary|Pharmacoeconomics: Annual Days Lost Due to Bleeding (Work or School)||12 months ± 14 days|Intent to Treat Analysis Set||days||Standard Deviation|Mean
95586|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia B Participants With Shifts in Factor IX (FIX) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):~Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)~Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)~Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)~Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set~- Hemophilia B study participants"||Bethesda Units (BU)||Inter-Quartile Range|Median
95587|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia A Participants With Shifts in Factor VIII (FVIII) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):~Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)~Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)~Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)~Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set~- Hemophilia A study participants"||Bethesda Units (BU)||Inter-Quartile Range|Median
95588|NCT00851721|Secondary|Number of Related Thromboembolic Adverse Events (AEs)||12 months ± 14 days|Safety Analysis Set||Related thromboembolic AEs|||Number
95589|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) During or Within 1 Hour of Infusion Per Year||12 months ± 14 days|Safety Analysis Set||Related AEs within/during 1hr per year||Inter-Quartile Range|Median
95590|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) Per Year||12 months ± 14 days|Safety Analysis Set||Related AEs per year||Inter-Quartile Range|Median
95591|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgM Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)~- Parvovirus B19 IgM Antibody [IV] (Parvo IgM Ab)"|12 months ± 14 days|Safety Analysis Set||participants|||Number
95592|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgG Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)~- Parvovirus B19 IgG Antibody [IV] (Parvo IgG Ab)"|12 months ± 14 days|Safety Analysis Set||participants|||Number
95593|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: HIV-1/2 Antibody (Ab)||12 months ± 14 days|Safety Analysis Set||participants|||Number
95594|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Hepatitis A, Hepatitis B, and Hepatitis C|"Hepatitis A Virus Antibody (HAV Ab)~Hepatitis B Virus Core Antibody (HBcAb)~Hepatitis B Virus Surface Antibody (HBsAb)~Hepatitis B Virus Surface Antigen (HBsAg)~Hepatitis C Virus (HCV)"|12 months ± 14 days|Safety Analysis Set||participants|||Number
95595|NCT00851721|Secondary|Abnormal Thrombin-Antithrombin III (TAT) Assay Results|The normal reference range of values for TAT is 1-4.1 ug/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||ug/L||Inter-Quartile Range|Median
95596|NCT00851721|Secondary|Abnormal Prothrombin Time Assay Results|The normal reference range of values for PT is 9.7-12.3 sec.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||seconds||Inter-Quartile Range|Median
95599|NCT00851721|Secondary|Abnormal Fibrinogen Assay Results|The normal reference range of values for fibrinogen is 200-400 mg/dL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||mg/dL||Inter-Quartile Range|Median
95600|NCT00851721|Secondary|Abnormal D-Dimer Assay Results|The normal reference range of values for D-dimers is <500 ng/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||ng/mL||Inter-Quartile Range|Median
95601|NCT00851721|Secondary|Abnormal Activated Partial Thromboplastin Time (aPTT) Assay Results|The normal reference range of values for aPTT is 22.8 – 31 seconds.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results||seconds||Inter-Quartile Range|Median
95602|NCT00851721|Secondary|The Number of Bleeding Episode (BE) Which Required 1, 2, 3, or ≥4 Infusions to Control Bleeding||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set~- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."||Bleeding Episodes (BEs)|||Number
95603|NCT00851721|Secondary|Total Weight Adjusted Dose to Control a Bleeding Episode||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set~- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."||Units/kg||Inter-Quartile Range|Median
95604|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 24 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~24 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~24 hours after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~24 hours after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|24 ± 1 h post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)||bleeding episodes|||Number
95605|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 6 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~6 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~6 hours after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~6 hours after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|6 h ± 30 min post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)||bleeding episodes|||Number
95606|NCT00851721|Secondary|Assessment of Clinical Symptoms - Range of Motion (ROM)|ROM was measured using a goniometer for 3 key joints (ie, ankles, knees, and elbows) at screening, month 6, and termination (end of study visit)|12 months ± 14 days|Safety Analysis Set||degrees||Inter-Quartile Range|Median
95607|NCT00851721|Secondary|Assessment of Clinical Symptoms - Visual Analog Scale (VAS): Pain in Pediatrics (<12 Years Old)|"Pain caused by a bleeding episode (BE) in pediatric participants (<12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 h and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) using the children’s VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (worst possible pain).~Scores on the children's VAS scale are presented as:~No Pain~Mild Pain~Moderate pain~Severe pain~Very severe pain"|12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.||Bleeding episodes|Bleeding episodes (BEs)||Number
95608|NCT00851721|Secondary|Assessment of Objective Clinical Symptoms- Visual Analog Scale (VAS): Pain in Adolescents and Adults (≥12 Years Old)|"Pain caused by a bleeding episode in adolescents and adults (≥12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 hours (h) and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) on the VAS pain scale in millimeters from 0 (no pain) to 100 (worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (100). Pain assessment occurred after each infusion related to single bleeding episodes. In case participants required an additional infusion within 24h, pain was assessed 6 ± 0.5 h and 24 ±1 h following the subsequent infusion.~Change in VAS scores at 6 ± 0.5 h and 24 ±1 h post-infusion were also compared relative to pre-infusion VAS scores (ie, (pre-infusion VAS score) - (post-infusion VAS score))."|Throughout the study period, 12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.||Scores on a scale|Bleeding episodes|Inter-Quartile Range|Median
95609|NCT00851721|Secondary|Number of New Target Joints|Target Joints are defined as ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows and hips|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||new target joints|||Number
95610|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens: New Target Joints|"Annualized bleed rates (ABRs) were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using a two-sample, two-sided t-test.~The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||(bleeds/year)^(1/2)||Standard Deviation|Mean
95655|NCT00852137|Secondary|Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area|Percentage (%) change in actinic keratosis (AK) lesions count at Day 57, compared to baseline, in a 25 cm^2 area within the selected treatment area.|Baseline and Day 57|||change from baseline lesion count (%)||Standard Deviation|Mean
95611|NCT00851721|Secondary|Annualized Bleeding Rate for New Target Joints|Target joints are ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows, and hips; a target joint bleeding episode refers to an individual anatomical location.|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||Bleeds per year||Inter-Quartile Range|Median
95612|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens by Bleeding Etiology, and Bleeding Type|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test.~The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%~Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:~On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician~Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period"|12 months ± 14 days|Efficacy Intent to Treat Analysis Dataset||(bleeds/year)^(1/2)||Standard Deviation|Mean
95613|NCT00851721|Secondary|Annualized Bleeding Rate by Treatment Regimen, Bleeding Etiology, and Bleed Type|Spontaneous includes unknown/undermined etiology|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||Bleeds per year||Inter-Quartile Range|Median
95614|NCT00851721|Primary|Reduction in Annualized Bleeding Episode Rate (ABR) Among Participants Receiving Prophylactic Treatment as Compared to Those Treated On-demand|"Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:~On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician~Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period~Annualized rate of bleeding episodes was calculated as:~(Number of bleeding episodes/observed treatment period in days) * 365.25"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."||bleeds/year||Inter-Quartile Range|Median
95615|NCT00851682|Secondary|Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.|Ultrasound guidance of transrectal ultrasound biopsy was not attempted.|At time of treatment||||||
95616|NCT00851682|Primary|Improved Accuracy of Prostate Cancer Detection by MRI Scan.|Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.|At time of treatment||||||
95617|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."||Participants|||Number
95618|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase A)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."||Participants|||Number
95619|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."||mMU/mL||95% Confidence Interval|Geometric Mean
95620|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase A)|Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.||mMU/mL||95% Confidence Interval|Geometric Mean
95621|NCT00851630|Secondary|HIV RNA Level < 50 Copies/ml|The number of subjects with plasma HIV RNA level <50 copies/ml.|104 Weeks|Intent to Treat, missing = failure.||Participants|||Number
95622|NCT00851630|Secondary|Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml|The number of subjects with plasma HIV RNA level <400 copies/ml.|104 Weeks|Intention to Treat Analysis, missing = failure.||Participants|||Number
95623|NCT00851630|Primary|Tuberculosis-immune Reconstitution Inflammatory Syndrome Events|Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions.|104 weeks|Intention to treat.||Events|||Number
95624|NCT00851630|Primary|Number of Serious Adverse Events (SAEs)|Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity.|104 weeks|Intention to treat.||Events|||Number
95625|NCT00852631|Secondary|Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|Day 14|The number of patient is different, because some of them withdraw/terminate during the study.||Scores on a scale||Standard Deviation|Mean
95626|NCT00852631|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.~Minimum value considered better is score decreased from baseline at least 30%."|From Day 1 (baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.||Scores on a scale||Standard Deviation|Mean
95627|NCT00852631|Secondary|Change in Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|From Day 1 (Baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.||Scores on a scale||Standard Deviation|Mean
95628|NCT00852592|Secondary|Global Assessment of Functioning (GAF)|The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.|6-weeks|||units on a scale||Standard Deviation|Mean
95629|NCT00852592|Primary|SIGH-ADS Depression Score|The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.|6 weeks|||units on a scale||Standard Deviation|Mean
95630|NCT00852540|Secondary|Mean Wound Size at Visits 1, 2, 3, 4, and 5|Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing data were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||centimeters squared (cm^2)||Standard Deviation|Mean
95631|NCT00852540|Secondary|Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5|The investigator evaluated skin infections by grading the infected lesion for exudate (a fluid that leaks out of blood vessels into surrounding tissue)/pus, crusting, erythema (redness of the skin)/ inflammation (E/I), tissue warmth, tissue edema (swelling), itching, and pain, according to the Skin Infection Rating Scale. All parameters were graded on a scale of 0 (absent) to 6 (severe). The total score is calculated by summing the individual scores from the 7 parameters; the total score ranges from 0 to 42.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing Skin Infection Rating Scale scores were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||scores on a scale||Standard Deviation|Mean
95632|NCT00852540|Secondary|Number of Participants With Therapeutic Response at Follow-up|"Therapeutic response is defined as the combined clinical and microbiological response. Therapeutic response iss a measure of the overall efficacy response, and a therapeutic success refers to participants who had been deemed both a “clinical success” and a “microbiological success. All other combinations (other than “clinical success” + “microbiological success”) were deemed failures for therapeutic response."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|ITTB Population||participants|||Number
95633|NCT00852540|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTB Population||pathogens|||Number
95634|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTC Population. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||participants|||Number
95635|NCT00852540|Secondary|Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population||participants|||Number
95636|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population||participants|||Number
95637|NCT00852540|Secondary|Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)|MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was “clinical success (CS)/improvement,” the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a “CS” such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a “CS.”|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Bacteriology (ITTB) Population: all randomized participants who took at least one dose of study medication and who had a pathogen isolated at baseline.||participants|||Number
95638|NCT00852540|Secondary|Number of Participants With Clinical Response at Follow-up|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Clinical (ITTC) Population: all randomized participants (par.) who took at least one dose of study medication. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.||participants|||Number
95639|NCT00852540|Secondary|Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)|MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was “clinical success (CS)/improvement,” the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a “CS” such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a “CS.”|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.||participants|||Number
95640|NCT00852540|Primary|Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.||participants|||Number
95641|NCT00852527|Primary|Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)|Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.|All OEF/OIF Veterans to receive TCRS upon enrollment in VA|Although 456 participants were consented and enrolled in the study, data for 13 participants had missing assessment data and another 5 were determined to have moderate TBI resulting in 438 cases for the analysis.||Percentage of participants||95% Confidence Interval|Number
95642|NCT00852475|Secondary|Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .|Ultrasonographic imaging of the brachial artery (BART) was used to assess endothelium-dependent flow-mediated vasodilation (FMD) in participants at rest. To do this,the blood pressure cuff is inflated to 200 mm Hg and kept inflated for 5 minutes. On immediate release of the cuff, the brachial artery was imaged within 1 minute after cuff release.|6 months from Baseline|||percentage of change from baseline||Standard Error|Mean
95643|NCT00852475|Primary|Weight Changes in Veterans With MetS.||6 months from Baseline|||kg||Standard Error|Mean
95654|NCT00852137|Secondary|Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study.|Number of patients with LSR at any time point during the study above 0. The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0–24.|baseline and Day 2, 3, 8, 15, 29 and 57|||participants|||Number
95644|NCT00852397|Other Pre-specified|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.|"TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).~TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
95645|NCT00852397|Other Pre-specified|Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.|"ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.~ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
95646|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.|Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]).|From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])|The efficacy analysis set was all randomized participants.||Percentage of Participants||95% Confidence Interval|Number
95647|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.||For 30 days after Week 24 or the discontinuation of study drug|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
95648|NCT00852397|Secondary|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.|TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
95649|NCT00852397|Secondary|Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.|Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
95650|NCT00852397|Secondary|Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.|All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
95651|NCT00852397|Primary|Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).||Percentage of Participants||95% Confidence Interval|Number
95652|NCT00852137|Secondary|Max Composite Local Skin Response (LSR) Score|Max composite Local Skin Response (LSR) score on day 3 only . The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0–24. (One vehicle treated patent had a LSR on day 1 only).|Day 3|||local skin response score||Standard Deviation|Mean
95653|NCT00852137|Secondary|Patients With Incidence of Pigmentation and Scarring|Patients with Incidence of pigmentation and scarring, and grade of pigmentation and scarring, following study treatment through Day 57|Baseline, Day 2, 3, 8, 15, 29 and 57|||participants|||Number
95656|NCT00852137|Secondary|Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area|Number of participants with complete clearence. Complete clearance rate is defined as no clinically visible actinic keratosis (AK) lesions in a 25 cm^2 area within the selected treatment area at Day 57 compared to baseline|baseline and day 57|||participants|||Number
95657|NCT00852137|Primary|Area Under the Blood Conc. Versus Time Curve for Time 0–24 Hours (AUC(0-24)) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Area under the blood conc. versus time curve was calculated for time 0–24 hours (AUC(0-24)) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day|||ng/mL x h||Standard Deviation|Mean
95658|NCT00852137|Primary|Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels.|Time at which Cmax is attained (Tmax) for ingenol mebutate, and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. If a maximum value occured at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day|||hours|||Number
95659|NCT00852137|Primary|Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Maximum observed concentration (Cmax) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels over the 24 hour sampling time period based on actual values measured. Blood samples were taken: at 30 minutes, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day|||ng/mL||Standard Deviation|Mean
95660|NCT00852124|Primary|To Establish the Safety of VSL#3 in Adults Asthmatics|Change in FEV|3 months|3 people were randomized to this arm but no data were analyzed due to early termination of study|||||
95661|NCT00851903|Secondary|Change in Body Weight From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value|The population analyzed was the safety population with both baseline and endpoint values available||kg||Standard Deviation|Mean
95662|NCT00851903|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment period (12 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population||participants|||Number
95663|NCT00851903|Secondary|Insulin Dose|Daily dose at the face-to-face visits|baseline, week 4, week 8, week 12|mITT population||unit per kg body weight||Standard Deviation|Mean
95664|NCT00851903|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|"The population analyzed consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing."||mg/dL||Standard Deviation|Mean
95665|NCT00851903|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure||mg/dL||Standard Deviation|Mean
95666|NCT00851903|Secondary|HbA1c: Change From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure||percent||Standard Deviation|Mean
95667|NCT00851903|Primary|HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)||study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had HbA1c value at study endpoint.||percentage of participants||95% Confidence Interval|Number
95668|NCT00851890|Secondary|Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28|Phenotypic resistance to ABT-333 was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the corresponding baseline sample, and the maximal fold change in EC50 from baseline over the Day 5-28 period. The resistance sample drawn before the first dose of ABT-333 on Day 1 was defined as the baseline sample. The number of participants with phenotypic resistance in the post-baseline samples are presented.|Days 1 through 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||participants|||Number
95669|NCT00851890|Secondary|Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28|Samples from Days 1, 5, 10, 17, 24 and 28 were analyzed for the presence of resistance-associated amino acids using population sequencing and compared to the baseline non-structural viral protein 5B (NS5B) sequence to assess amino acid changes. The amino acid sequence of NS5B before the first dose of ABT-333 on Day 1 was defined as the baseline sequence. The number of participants with variants at resistance-associated amino acid positions in the post-baseline samples are presented.|Days 1, 5, 10, 17, 24 and 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||participants|||Number
95670|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of detection (LLOD) was defined as a HCV RNA level equal to 10 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).||percentage of participants|||Number
99852|NCT00814671|Secondary|To Evaluate the Microbiological Activity of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment, Based on Time to Sputum Culture Conversion||8 weeks||||||
95671|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of quantification (LLOQ) was defined as HCV RNA levels ≤ 25 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).||percentage of participants|||Number
95672|NCT00851890|Secondary|Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. Data are reported as the percentage of participants.|Prior to the first dose on Day 1 and Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||percentage of participants|||Number
95673|NCT00851890|Secondary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1 and the Day 28 or Final Visit value was the last HCV RNA measurement during the study. Data are reported as the least squares mean change from baseline ± standard error.|Day 28 and Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||log10 IU/mL||Standard Error|Least Squares Mean
95674|NCT00851890|Primary|Number of Participants Having Treatment-emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not have a causal relationship with treatment. An Adverse Drug Reaction (ADR) was any noxious and undesired reaction related to the experimental drug or experiment. A serious adverse event (SAE) was an AE that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in congenital anomaly, was persistent or caused significant disability/incapacity, spontaneous or elective abortion, or required intervention to prevent a serious outcome. AEs were rated for severity as either:~Mild - transient and easily tolerated;~Moderate - caused discomfort and interrupted usual activities;~Severe - caused considerable interference with usual activities, may be incapacitating or life-threatening.~AEs related to direct-acting antiviral agents (DAAs) were assessed as being either probably or possibly related by the investigator."|AEs were collected from the time of study drug administration to 30 days after last dose of study drug (8 Weeks)|Participants received at least 1 dose of study drug.||participants|||Number
95675|NCT00851890|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Standard Deviation|Mean
95676|NCT00851890|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.||ng/mL||Standard Deviation|Mean
95677|NCT00851890|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) measures the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng*hr/mL||Standard Deviation|Mean
95678|NCT00851890|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||Hours||Standard Deviation|Mean
95722|NCT00851084|Secondary|Immunogenicity of Intravenous (IV) Aflibercept|The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept.|Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status|Participants treated with aflibercept and evaluable for antibody assessment.||participants|||Number
95679|NCT00851890|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
95680|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during treatment was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level on Day 28. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 through Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||log10 IU/mL||Standard Error|Least Squares Mean
95681|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during monotherapy was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 3. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 to before first dose on Day 3|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.||log10 IU/mL||Standard Error|Least Squares Mean
95682|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
95683|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
95684|NCT00851799|Secondary|Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96|Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
95685|NCT00851799|Secondary|Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96|Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
95686|NCT00851799|Secondary|Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96|IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
95687|NCT00851799|Secondary|Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96|hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
95688|NCT00851799|Secondary|Fold Change in D-dimer From Study Entry to Weeks 48 and 96|D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||Fold change||Inter-Quartile Range|Median
95689|NCT00851799|Secondary|Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96|Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||uIU/dL||Inter-Quartile Range|Median
95690|NCT00851799|Secondary|Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96|Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
95691|NCT00851799|Secondary|Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96|Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
95692|NCT00851799|Secondary|Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96|HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
95693|NCT00851799|Secondary|Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96|Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
95694|NCT00851799|Secondary|Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96|Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mg/dL||Inter-Quartile Range|Median
95695|NCT00851799|Secondary|Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144|Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry).|Study entry to weeks 24, 48, 96, and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.||cell/mm^3||Inter-Quartile Range|Median
95696|NCT00851799|Secondary|CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144|The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144.|Study entry, weeks 24, 48, 96 and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.||cell/mm^3||Inter-Quartile Range|Median
95697|NCT00851799|Secondary|Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96|Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95698|NCT00851799|Secondary|Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96|Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95699|NCT00851799|Secondary|Percent Change in Lean Mass From Study Entry to Week 96|Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95700|NCT00851799|Secondary|Percent Change in Trunk Fat From Study Entry to Week 96|Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95701|NCT00851799|Secondary|Percent Change in Total Limb Fat From Study Entry to Week 96|Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95702|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96|Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95703|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96|Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95704|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96|Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257||percent||Inter-Quartile Range|Median
95705|NCT00851799|Secondary|Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48|The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.|Study entry, weeks 4, 24 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||mm||Standard Deviation|Mean
95706|NCT00851799|Secondary|Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, weeks 4 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||95% Confidence Interval|Mean
95707|NCT00851799|Primary|Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, week 24|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||percent||Inter-Quartile Range|Median
95708|NCT00851799|Primary|Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)|"Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.~The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors."|Study entry, week 144|Intention to treat; all eligible participants were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.||micron/year||95% Confidence Interval|Mean
95709|NCT00851591|Secondary|Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.||day 0; day 8||||||
95710|NCT00851591|Primary|The Main Outcome Variable of This Study is the Quantity of Milk Produced.|The single value was calculated average from day 0 and day 8.|"Day 0 , Day 8"|Analysis was per protocol.||mL/hr||Standard Deviation|Mean
95711|NCT00851552|Secondary|Safety||2 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
95712|NCT00851552|Primary|Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21||at weeks 9 and 21|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
95713|NCT00851409|Secondary|"The Evaluation of Pharmacokinetic/ Pharmacodynamic (PK/PD)Parameters."|"PK/PD parameters will be based on concentration time curves after the 1st and 8th rhC1INH administration.(ratio visit 8/ visit 1, based on the area under the curve from baseline up to 4 hours after administration (AUC 0-4)"|8 weeks|||ratio||95% Confidence Interval|Geometric Mean
95714|NCT00851409|Primary|HAE Attacks/Week|"Prior to the treatment period, patients enrolled in the study, were asked about the amount of HAE attacks in the past 2 years, (calculated to attacks/week), this number is defined as Historical. During the treatment period, patients received a dose of 50 IU/kg of rhC1INH administered by slow IV injection over 4 to 5 minutes, once a week during an eight week period. The amount of attacks during this period is defined as Prophylaxis (calculated to attacks/week)."|8 weeks|||attacks/week||95% Confidence Interval|Mean
95751|NCT00849485|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
95715|NCT00851318|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.~The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.||units on a scale||Standard Deviation|Mean
95716|NCT00851318|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count;~28 swollen joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity.~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~The data before study drug administration of 275-08-001 Study was utilized for Baseline.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||units on a scale||Standard Deviation|Mean
95717|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug, with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
95718|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
95719|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
95720|NCT00851318|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.~A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).||participants|||Number
95721|NCT00851279|Primary|Percentage of Participants Free From VT at 1 Year Post-Treatment|In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.|1 Year follow-up|||percentage of participants free from VT|||Number
95723|NCT00851084|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs.|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|Of the total 235 patients included in the safety population, 116 patients received mFOLFOX6 and 119 patients received mFOLFOX6 + aflibercept. One patient, randomly assigned to the mFOLFOX6 arm did not receive any study treatment and was therefore excluded from the safety analyses.||participants|||Number
95724|NCT00851084|Secondary|Overall Survival (OS)|"Overall survival was defined as the time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earliest between the last date the patient was known to be alive and the study cutoff date.~The study was not powered for comparison of OS between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized. Of the 268 screened participants, 236 were randomly assigned to treatments, whereas 32 participants were screen failures.||months|Participants|95% Confidence Interval|Median
95725|NCT00851084|Secondary|Overall Objective Response Rate (ORR)|"Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.~Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable Patient population.||percentage of participants||95% Confidence Interval|Number
95726|NCT00851084|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.~The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).~Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable patient (EP) population. A total of 55 patients (32 in the mFOLFOX6 group and 23 in the mFOLFOX6 + aflibercept group) were without an event at the cutoff date for the PFS analysis by IRC.||Months|Participants|95% Confidence Interval|Median
95727|NCT00851084|Primary|Progression Free Survival (PFS) Rate at 12 Months|PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|12 months|Analyses of PFS rate was performed in the evaluable patient (EP) population as the primary analysis population. Overall, 9 patients from the randomized population were excluded from the EP population.||percentage of participants||95% Confidence Interval|Number
95728|NCT00851006|Secondary|31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite|Phosphocreatine Metabolite is a phosphorylated creatine molecule that plays a role in the production of the energy in the body. Phosphocreatine (PCr) metabolite was quantified by calculating the ratio of PCr over total phosphorus resonance from 31-Phosphorus Magnetic Resonance Spectroscopy.|8 weeks|||ratio of PCr and total phosphorus||Standard Deviation|Mean
95729|NCT00851006|Primary|Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.]|The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission|8 weeks|"This outcome measure was not assessed in the Healthy Controls. Only subjects in treatment group were evaluated with CDRS-R and received scores."||Units on a scale||Standard Deviation|Mean
95730|NCT00850993|Secondary|Change From Baseline in Unadjusted Total Serum Bilirubin (TSB) at 48 Hours (ITT Population|Change from Baseline in Unadjusted TSB at 48 Hours (ITT Population)|48 hrs|||TSB (mg/dL)||95% Confidence Interval|Least Squares Mean
95731|NCT00850993|Primary|The Primary Efficacy Endpoint Was the Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.|"The primary efficacy endpoint was the change in adjusted TSB from baseline to 48 hours after treatment.~The adjusted Total Serum Bilirubin (TSB) was a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the AAP Guidelines, ie, an indication of the distance below the PT threshold at the time."|48 hours after injection|Intent-to-treat population (ITT): Defined as all patients who were randomly assigned treatment in the clinical study, had received stannsoporfin or placebo, and had at least 1 post baseline TSB measurement during the first 48 hours after treatment. Patients were summarized based on randomized treatment.||adjusted TSB (% of Threshold)||95% Confidence Interval|Least Squares Mean
95732|NCT00850889|Secondary|Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity|Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14|||units on a scale||Standard Deviation|Mean
95733|NCT00850889|Secondary|Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity|Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14|||units on a scale||Standard Deviation|Mean
95734|NCT00850889|Secondary|Comparative Pain|A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day|||percent of participants|||Number
95735|NCT00850889|Primary|Procedural Pain Score|Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day|||units on a scale||Standard Deviation|Mean
95736|NCT00850759|Primary|Street-crossing Ability|average count of hits/close calls per participant in virtual environment, out of 30 crossings|post-training and again 6 months later|||number of hits/close calls||Standard Deviation|Mean
95737|NCT00850720|Primary|NO Outcomes - Study Terminated Without Data.||Study terminated - no data.||||||
95738|NCT00850603|Primary|Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.|GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.|Baseline (Day 0) and Day 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
95739|NCT00850603|Secondary|Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.|Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®|Day 0 to 7 days post-vaccination|||Participants|||Number
95740|NCT00850603|Primary|Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers|Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.|Baseline to 28 days post vaccination|4-Fold rise analysis was in the per-protocol population with valid serology data||Percentage of participants|||Number
95741|NCT00850564|Secondary|Insulin Stimulated Glucose Utilization|Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)|||mg/kg/min||Standard Error|Mean
95742|NCT00850564|Primary|Mean Overnight Growth Hormone|Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)|analysis of 13 participants who completed both baseline and 2 week visits||mcg/L||Standard Error|Mean
95743|NCT00850538|Primary|Number of Participants With Viable Specimens for Genetic Analysis||Tissue samples collected at time of surgery|||participants|||Number
95744|NCT00850499|Secondary|Overall Response Rate|The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug||participants|||Number
95745|NCT00850499|Primary|Complete Response Rate|The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug||participants|||Number
95746|NCT00850460|Primary|Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8|Scores from the self-administered SF-36 (Physical component) questionnaire were measured at the start (Week 0) of the study and at the end (Week 8) among patients in the placebo- and statin-treated group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of scores.|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.||units on a scale||Full Range|Mean
95747|NCT00850460|Primary|Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8|Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.||units on a scale||Full Range|Mean
95748|NCT00849524|Secondary|Determine Pharmacodynamic Parameters in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.|||||
95749|NCT00849524|Secondary|Determine the Safety of Repeat Administration of Ad-ISF35 Injected Directly Into Lymph Nodes of Patients With CLL/SLL.||2 years (evaluation will be approx. 1 year per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.|||||
95750|NCT00849524|Primary|Determine and Monitor Clinical and Biological Responses in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.|||||
95752|NCT00849485|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
95753|NCT00849485|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
95754|NCT00850421|Secondary|To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.||190 days||||||
95755|NCT00850421|Secondary|To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days||||||
95756|NCT00850421|Primary|To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design defecits.|||||
95757|NCT00850395|Secondary|Number of Participants Taking Concomitant Therapy|Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).|Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.||participants|||Number
95758|NCT00850395|Secondary|Physician's Assessment of Efficacy|Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.||participants|||Number
95759|NCT00850395|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) Response|Response was defined as a HIV-1 RNA count of less than 50 copies/mL.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.||participants|||Number
95760|NCT00850395|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12|SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant’s quality of life over that period.|Baseline, Months 6, 12|FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||units on a scale||Standard Deviation|Mean
95761|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||participants|||Number
95762|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
95763|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
95764|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||cells/mcL||Standard Deviation|Mean
95765|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
95766|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3||Baseline, Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
95767|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.||copies/mL||Standard Deviation|Mean
95768|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||copies/mL||Standard Deviation|Mean
95769|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3||Baseline, Month 3|Full Analysis Set (FAS) population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||copies/mL||Standard Deviation|Mean
95770|NCT00850343|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.~The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.||units on a scale||Standard Deviation|Mean
95771|NCT00850343|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count;~28 swollen joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity.~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~The data before study drug administration of 275-08-003 Study was utilized for Baseline.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|"The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used. N indicates the number of participants with available data at each time point."||units on a scale||Standard Deviation|Mean
95772|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
95773|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
95774|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.||percentage of participants||95% Confidence Interval|Number
95788|NCT00850096|Primary|Continuous Glucose Monitoring (CGM)|Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.|Baseline and 5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.||Percentage of day (24h) in euglycemia||Standard Error|Mean
95789|NCT00850070|Secondary|Parent Global Assessment (PGA) Scale||Baseline, 8 weeks, and 16 weeks||||||
96366|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
95775|NCT00850343|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.~A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).||participants|||Number
95776|NCT00850200|Secondary|Assess Disease Control and Survival Outcomes||During radiation therapy; then after radiation, every 3 months for the first year, then every 6 months for the next 4 years, then annually||||||
95777|NCT00850200|Secondary|Assess Improvement and Other Dosimetric Endpoints||Prior to starting radiation therapy||||||
95778|NCT00850200|Primary|Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.||Immediately proceeding completion of each of the three treatment plans|||percentage of body receiving 4 Gy||Full Range|Median
95779|NCT00850174|Secondary|AUC0-t - 10-hydroxy-carbazepine Metabolite|Results of metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
95780|NCT00850174|Secondary|AUC0-inf - 10-hydroxy-carbazepine Metabolite|Results of Metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
95781|NCT00850174|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Results of Metabolite for Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
95782|NCT00850174|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
95783|NCT00850174|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis. AUC0-inf was not able to be estimated from all data sets.||ng*h/mL||Standard Deviation|Mean
95784|NCT00850174|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
95785|NCT00850135|Secondary|Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000|"For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile.~Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into “high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values."|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|A total of 57 patients were enrolled from two clinical sites. Of these patients, 44 were screened with the 1-hour 50-g GCT; 9 were screened with 2-hour 75-g GTT. Complete data on secondary outcomes was available for 43 patients with 1-hour 50-g GCT and these were analyzed.||participants|||Number
95786|NCT00850135|Primary|Correlation Between Glucose AUC and Birth Weight.|For each patient’s CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values “AUC-110,” “AUC-120,” “AUC-130,” “AUC-140,” and “AUC-180,” and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|"A total of 57 patients were enrolled from two clinical sites. Two patients did not have monitoring or delivery data.~Two patients who had an existing diagnosis of diabetes were excluded. The remaining 53 patients were analyzed."||correlation coefficient|||Number
95787|NCT00850096|Secondary|Overall Glycemic Control|Continuous glucose monitoring (CGM) data from patients at the last weeks of study (week 5-6) were averaged for assessment of glycemic control under the treatment of either Nasulin or placebo.|5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.||mg/dl||Standard Error|Mean
95826|NCT00849797|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
95827|NCT00849797|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
95790|NCT00850070|Secondary|Social Responsiveness Scale (SRS)|The SRS is a 65-item scale used to measure the severity of symptoms in ASD as they occur in natural social settings. The SRS is comprised of 1 Total scale and 5 subscales that generate raw scores that can be converted to standard T-scores (with mean of 50 and standard deviation of 10) for gender and rater type; standard scores were selected for use in this study. A total T-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of autistic disorder. A t-score of 60-75 is in the mild to moderate range and considered typical for children with mild or 'high-functioning' ASD, while a T-score of 59 or less suggests an absence of ASD symptoms. A total raw score of >75 were associated with a sensitivity value of .85 and a specificity value of .75 for ASD. Difference in scores between baseline and week 16 were used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.||units on a scale||Standard Deviation|Mean
95791|NCT00850070|Primary|Clinical Global Impression -- Severity (CGI-S) Scale|The CGI-S assessed the number of participants with improved severity illness on the CGI-S scale. This is a summary judgment made by a trained clinician of symptom severity. It is a 7-point scale that rates the severity of the patient's illness at time of assessment with 1 - normal, not at all, to 7 - extremely ill. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Baseline, 8 weeks, and 16 weeks. Primary outcome assessment used 2 time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at number of children who improved (from markedly, severely or extremely ill to markedly, mildly or no illness) at 16-week time frame.||participants|||Number
95792|NCT00850070|Secondary|Aberrant Behavior Checklist (ABC) - Inappropriate Speech|Subscale assessing echolalia & other odd speech. Higher subscale scores indicate more symptoms. 4 items comprise the subscale, with range of scores from 0-4. Total score range on this subscale is 0 to 16. Scores are averaged to compute overall score. Difference in scores between baseline and week 16 were used as indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent to treat analysis||units on a scale||Standard Deviation|Mean
95793|NCT00850070|Secondary|Adverse Events Scale||Every 1-2 weeks for 16 weeks||||||
95794|NCT00850070|Secondary|Connor's Preschool ADHD Questionnaire||Baseline, 8 weeks, and 16 weeks||||||
95795|NCT00850070|Secondary|Children's Yale Brown Obsessive Compulsive Scale (C-YBOCS)||Baseline, 8 weeks, and 16 weeks||||||
95796|NCT00850070|Secondary|Vineland Adaptive Behavior Scale-II.|the Vineland-2 is a semi-structured interview designed to assess communicatino, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. Scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in the study. Raw score ranges from 0 to 108 depending on the scale. Total raw scale range is from 0 to 766. Subscale scores are averaged to create the total adaptive behavior composite. Higher subscale scores indicate more skills. Difference between baseline and week 16 was used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.||units on a scale||Standard Deviation|Mean
95797|NCT00850070|Secondary|Preschool Language Scale-Fourth Edition (PLS-4). Assesses Expressive and Receptive Language Skills in Ages Birth Through 6 Years, 11 Months.|Measures expressive & receptive language and total scores in ages birth to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher scores indicate better language abilities. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. For the outcome effect, the difference between baseline and 16 weeks was determined as an indicator for change.|Primary outcome assessment examined the difference in scores between baseline and week 16.|Intent-to-treat analysis; all subjects included. Difference in scores between baseline and 16 weeks was used as treatment outcome.||units on a scale||Standard Deviation|Mean
95798|NCT00850070|Primary|Clinical Global Impression -- Improvement (CGI-I) Scale|The CGI-I assessed the number of participants showing much or very much improvement on the CGI-I scale. This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale from very much worse (1) to very much improved (7). Chi-square analyses were used to assess change in CHI-I scores (by group, post-test). Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weekly for 4 weeks, then monthly, with 16-week end point. Primary outcome assessment used two time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at percentage of children who improved (showing much or very much improved ratings) at 16-week time frame.||participants|||Number
95799|NCT00850031|Secondary|Improvement of Near Uncorrected Visual Acuity|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months|||units on a scale||Standard Deviation|Mean
95800|NCT00850031|Primary|Improvement in Uncorrected Near Visual Acuity|Percent of subjects who achieved UCNVA of 20/40 or better.|12 months|||percentage of participants|||Number
95801|NCT00849940|Secondary|Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.||Data collected from individual participants over 4 hour timeframe|Data not collected.|||||
95802|NCT00849940|Secondary|Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation||Data collected from individual participants over 4 hour timeframe|Data not collected|||||
95803|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation|The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 25.4 kg; age 0.04 - 10.2 years represent the values of the participants analyzed.||percentage of oxygen saturation||Standard Deviation|Mean
95804|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation|The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 24.0 kg; age 0.04 - 9.8 years represent the values of the participants analyzed.||percentage of oxygen saturation||Standard Deviation|Mean
95805|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation|"The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.~oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry."|Data collected from individual participants over 4 hour timeframe.|Weight range 3.9 - 49.5 kg; age 0.2 - 12.3 years represent the values of the participants analyzed.||percentage of oxygen saturation||Standard Deviation|Mean
95806|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participants with normal value at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.||percentage of participants|||Number
95807|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.||percentage of participants|||Number
95808|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.||participants|||Number
95809|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT <1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.||participants|||Number
95810|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
96367|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
95811|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0)."|Baseline through Week 10|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
95812|NCT00849901|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
95813|NCT00849901|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
95814|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
95815|NCT00849901|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
95816|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Deviation|Least Squares Mean
95817|NCT00849901|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
95818|NCT00849862|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
95819|NCT00849862|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg*h/mL||Standard Deviation|Mean
95820|NCT00849862|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||mcg/mL||Standard Deviation|Mean
95821|NCT00849810|Primary|Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.||4 weeks (pre- and post-treatment)|||mm HG||Standard Deviation|Mean
95822|NCT00849797|Secondary|AUC0-t - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
95823|NCT00849797|Secondary|AUC0-inf - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
95824|NCT00849797|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
95825|NCT00849797|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
95828|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participates with normal value before week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.||percentage of participants|||Number
95829|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.||percentage of participants|||Number
95830|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.||participants|||Number
95831|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT<1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.||participants|||Number
95832|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
95833|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0)."|Baseline through Week 10|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.||participants|||Number
95834|NCT00849693|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
95835|NCT00849693|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
95836|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
95880|NCT00849121|Primary|Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline.|The number of patients with a T-cell immune response will be determined for each study arm. An immune response will be defined as a PAP-specific T-cell frequency or proliferation index at 1 year that is at least 3-fold higher than the baseline T-cell frequency or proliferation index.|Baseline and 1 year.|||participants|||Number
95837|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline values.||units on a scale||Standard Error|Least Squares Mean
95838|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
95839|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.||units on a scale||Standard Error|Least Squares Mean
95840|NCT00849693|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.||units on a scale||Standard Error|Least Squares Mean
95841|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen|"Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).~No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious."|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.|||||
95842|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen|Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.|||||
95843|NCT00849680|Primary|Number of Participants With Laboratory Adverse Experiences|"Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.~All laboratory AEs were collected up to 29 days after any vaccine dose."|up to 260 weeks after first vaccination|Participants administered at least one dose of study vaccine. One participant who was lost to follow-up, and another one participant who discontinued as he comply with the protocol are not included.||Participants|||Number
95844|NCT00849680|Primary|Number of Participants With Adverse Experiences|"Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs.~Systemic and Laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body.~Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose."|up to 260 weeks after first vaccination|||Participants|||Number
95845|NCT00849472|Secondary|Number of Participants With Recurrence Events|The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population, excluding participants with recurrence before study entry||participants|||Number
95846|NCT00849472|Secondary|Number of Participants With the Indicated Radiotherapy-related Complications||up to 24 months after study entry|Treated Population||participants|||Number
96036|NCT00848237|Primary|Histological Clearance Rate for Dysplasia (CE-D)|percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis||percentage of participants|||Number
95847|NCT00849472|Secondary|Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods|The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges.|up to 24 months after study entry|Treated Population. Data are presented for only those participants who remained in the study during the indicated period and had their blood drawn for assessment.||participants|||Number
95848|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry)|Treated Population: Only those members of the Treated Population who started the postoperative pazopanib period were assessed.||Participants|||Number
95849|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry).|Treated Population||Participants|||Number
95850|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry)|Treated Population: all participants who entered the study and received at least one dose of any study medication||Participants|||Number
95851|NCT00849472|Secondary|Invasive Recurrence-free Interval (IRFI)|IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population. Participants with recurrence before study entry were excluded from analysis.||months||95% Confidence Interval|Median
95852|NCT00849472|Secondary|Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry)|Evaluable Population||Participants|||Number
95853|NCT00849472|Secondary|Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry|Evaluable Population||Participants|||Number
95854|NCT00849472|Secondary|Number of Participants With Pathologic Complete Response (pCR) in the Breast|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen.|From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry)|Evaluable Population||Participants|||Number
95855|NCT00849472|Primary|Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.|From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)|Evaluable Population: all participants who entered the study and received at least one dose of pazopanib.||Participants|||Number
95856|NCT00849381|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes|The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.|During the entire study period (up to Month 12)|The analysis was based on the subjects with positive pregnancy results in the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of Cervarix vaccine in this study and for whom data were available.||Subjects|||Number
95857|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire study period (up to Month 12)|||Subjects|||Number
95858|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Note: Results from one center where compliance issues were discovered are presented also separately."|During the entire study period (up to Month 12)|||Subjects|||Number
95859|NCT00849290|Secondary|To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response||periodically over 24 months||||||
95860|NCT00849290|Primary|Safety of APC8015F by Review of Reported Adverse Events|All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.|periodically over 24 months|All participants who received at least one infusion of APC8015F||participants|||Number
95861|NCT00849212|Secondary|Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF|The percent change in seizure frequency per 28 days during the maintenance period was collected via patient diary cards. This was calculated using the last observation carried forward (LOCF) method.|Baseline (Day -28 to Day 0), Week 1 to Week 10|"Efficacy analysis set:~Population after excluding : (a) Patients who do not meet the inclusion criteria, (b) Patients who meet the exclusion criteria which affect efficacy evaluation of E2007, (c) Patients untreated,(d) Patients with no evaluable data on efficacy,(e) Patients with <80% treatment compliance"||Percent change||Full Range|Median
95862|NCT00849212|Primary|Maximum Tolerated Dose (MTD)|MTD was defined by participants. For participants who completed treatment, MTD was dose at last administration. For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration. If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.|10 weeks (Titration and Maintenance Periods)|Safety analysis set||Participants|||Number
95863|NCT00849186|Secondary|Response Rate After 90 Days of Treatment With SM||90 days|All treated and eligible patients||proportion of participants||95% Confidence Interval|Number
95864|NCT00849186|Primary|Safety of Surgery After 90 Days of Treatment With SM|Incident Rate: Intraoperative Complication Rate|90 days|All treated and eligible patients||proportion of participants||95% Confidence Interval|Number
95865|NCT00849186|Primary|Safety of Sunitinib Malate (SM)|Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.|90 days|All treated and eligible patients||proportion of participants||95% Confidence Interval|Number
95866|NCT00849147|Secondary|Infections|Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.|Measured at Year 1|36 patients incurred a total number of 108 infection events.||participants|||Number
95867|NCT00849147|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year|||percentage of participants||95% Confidence Interval|Number
95868|NCT00849147|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.|Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
95869|NCT00849147|Secondary|Chronic GVHD||Measured at Year 1|||percentage of participants||95% Confidence Interval|Number
95870|NCT00849147|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100|||percentage of participants||95% Confidence Interval|Number
95871|NCT00849147|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56|||participants|||Number
95872|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 50K|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
95873|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 20K|Measured at Days 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
95874|NCT00849147|Secondary|Secondary Graft Failure|Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure.|Measured at Day 100|||participants|||Number
95875|NCT00849147|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements.|Measured at Day 67|||participants|||Number
95876|NCT00849147|Secondary|Neutrophil Recovery|Cumulative incidence of neutrophil recovery >500/μL at day +56|Measured at Days 28, 56, 90, and 100|||percentage of participants||95% Confidence Interval|Number
95877|NCT00849147|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1|||percentage of participants||95% Confidence Interval|Number
95878|NCT00849121|Secondary|The Number of Participants Who Are Metastasis-free at One Year.|The number of subjects who are metastatic-free at one year after starting study treatment will be tabulated for each arm. CT Scans and Bone Scans will be obtained at one year to determine whether metastatic disease is present.|one year from study entry|||participants|||Number
95879|NCT00849121|Secondary|The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.|The number of subjects who experience at least a two-fold increase in the PSA doubling time will be documented for each study arm. The PSA doubling time will be calculated using all PSA values obtained starting on Treatment Day 0 and continuing to end of treatment period and compared to the PSA doubling time collected at study entry prior to beginning study treatment.|Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years|||participants|||Number
95881|NCT00849121|Primary|Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.|The number and severity of toxicity incidents occurring between the pre-treatment and the final off-study evaluation will be collected and assigned an attribution. The toxicities observed will be summarized in terms of types and severities by the NCI Common Terminology Criteria version 3 for each study arm. The number of subjects experiencing grade 2 or higher autoimmune events or grade 3 or higher toxicities felt to be at least possibly related to pTVG-HP with GM-CSF study treatment will be compared between the two arms.|From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years|||participants|||Number
95882|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by specificity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing Visit|intent to treat, received at least one dose of BMS747158||Proportion of True Negative Cases|||Number
95883|NCT00849108|Primary|Cohort 1: Determination of Ratio of Stress Dose to Rest Dose|The stress flurpiridaz dose for subsequent same-day rest-stress efficacy studies was determined as a multiple of the rest dose by computer modeling. Images derived only from rest flurpiridaz administration were blended using image analysis with images derived only from administration of flurpiridaz following exercise or adenosine stress. The blending fraction that resulted in negligible change in reader interpretation of defect severity was determined for each subject. The minimum value that met this criterion for all subjects was used to calculate the ratio of the stress dose to the rest dose as a function of the delay between administration of the two doses for both adenosine stress and exercise stress separately. No statistical analysis was performed.|Dosing visit|Subjects with demonstrated partially or completely reversible defects on prior SPECT who received at least one stress and one rest dose of flurpiridaz F 18, on separate days.||Fraction of rest added to stress image|||Number
95884|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by sensitivity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing visit|intent to treat, received at least one dose of BMS747158||Proportion of True Positive Cases|||Number
95885|NCT00849108|Primary|Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product|The rest flurpiridaz dose to be used for subsequent efficacy studies was determined by a modeling method that simulated a range of injected doses using a single fixed injected dose at rest in each subject and a range of acquisition durations. From this, a dose acquisition time product (DATP was determined for each subject that specified the minimal dose for a given acquisition duration that yielded an image in that subject that was negligibly affected by photon counting statistics. Descriptive statistics were used to identify an appropriate rest dose for the population. No other statistical tests were performed|Dosing visit|Intent to treat, received at least one rest dose of BMS 747158||MBq X Minutes||Standard Deviation|Mean
95886|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Kilograms||Standard Deviation|Mean
95887|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
95888|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
95889|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Participants|||Number
95890|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
95942|NCT00848510|Primary|Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60)|IAUC 60 was used to give a gross indication of the delivery and uptake of contrast agent within the tumor (indicating the degree of perfusion and endothelial permeability. IAUC60 was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||(Millimoles/liter)*sec||Standard Deviation|Mean
95891|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
95892|NCT00849056|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
95893|NCT00849056|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
95894|NCT00849056|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles).||Percentage of HbA1c in the blood||Standard Deviation|Mean
95895|NCT00849017|Secondary|Albiglutide Plasma Concentration at Weeks 8 and 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
95896|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participant who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameters of insulin, proinsulin. The MM tolerance test was performed only in those participants who additionally consented to participate in.||picomoles/Liter (pmol/L)||Standard Error|Least Squares Mean
95897|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of glucose. The MM tolerance test was performed only in those participants who additionally consented to participate in.||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
95898|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid Baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of C-peptide.||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
95899|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Kilograms||Standard Deviation|Mean
95900|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
95901|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
95902|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Participants|||Number
95903|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
95904|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
95905|NCT00849017|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|IIT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
95906|NCT00849017|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
96037|NCT00848237|Primary|Histological Clearance Rate for Intestinal Metaplasia (CE-IM)|Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA||percentage of participants|||Number
95907|NCT00849017|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
95908|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for 7 steroid-responsive genes (DUSP_1_TI, FKBP5, GILZ, PLAU, CCL2, PTGS2, and RGS2) and 3 housekeeping reference genes (GAPDH, 18S, and b-actin). Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented are an average of the data collected on Day 1 and Day 8 of each treatment period. Only those participants contributing data at the indicated time points were analyzed.||RNA copies detected per 50 ng total RNA||95% Confidence Interval|Geometric Mean
95909|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for CCL2, a steroid-responsive gene. Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. CCL2 data are presented by period to show the treatment-by-period interaction. ng, nanograms.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented for each period are an average of the data collected on Day 1 and Day 8 of each period. Only those participants contributing data at the indicated time points were analyzed.||Copies of RNA detected per 50ng of total||95% Confidence Interval|Geometric Mean
95910|NCT00848965|Secondary|Weighted Mean Global Symptom Score (GSS) at 5 Hours Post-dose (1-4 Hours Post-start of Challenge)|GSS (total score=0-30) is calculated as the sum of sneeze, nasal itch, rhinorrhea, nasal obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes, and red eyes SSs, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), as was measured at pre-challenge, and then every 15 mins from 0.25 to 4 hours post-start of challenge chamber. Weighted mean global symptom score was evaluated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
95911|NCT00848965|Secondary|Weighted Mean Eye Symptom Score at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|The eye symptom score (total score of 0 [none] to 9 [severe]) was calculated as the sum of the symptom scores for watery eyes, itchy eyes, and red eyes, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), and was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours post-start of challenge chamber. Weighted mean eye symptom score was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
95912|NCT00848965|Secondary|Weighted Mean Nasal Secretion at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Nasal secretion was measured by weighing tissues used by participants. Wet tissue weight assessments were made pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of challenge chamber throughout the study. Weighted mean nasal secretion was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||grams (g)||Standard Deviation|Mean
95913|NCT00848965|Secondary|Weighted Mean Nasal Airflow at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Allergic rhinitis decreases the passage of air through the nose (nasal airflow) by increasing the nasal airway resistance. Rhinomanometry is used as an objective measurement of airway resistance. Nasal airflow was measured using active anterior rhinomanometry at pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of VCC. Weighted mean nasal airflow was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.||Milliliters per second (mL/s)||Standard Deviation|Mean
95943|NCT00848510|Primary|Blood Plasma Volume and Extravascular/Extracellular Volume|Blood plasma volume and extracellular/extravascular volume was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||milliliter||Standard Deviation|Mean
102261|NCT00795951|Primary|Diagnostic Performance: Diazolidinyl Urea|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
95914|NCT00848965|Primary|Weighted Mean Total Nasal Symptom Score (TNSS) at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge [PSC]) in the Vienna Challenge Chamber (VCC)|The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population: all participants randomized to receive at least one dose of study treatment. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
95915|NCT00848926|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||days||Full Range|Median
95916|NCT00848926|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
95917|NCT00848926|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline||percent of participants||95% Confidence Interval|Number
95918|NCT00848926|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
95919|NCT00848926|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
95920|NCT00848926|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment||participants|||Number
95921|NCT00848926|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment||participants|||Number
95922|NCT00848926|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to approximately 6 years|Intention to treat||months||95% Confidence Interval|Median
95923|NCT00848926|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to approximately 4 years|Intention to treat||months||95% Confidence Interval|Median
95924|NCT00848926|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to approximately 4 years|Participants with complete remission among the intention to treat population||months||95% Confidence Interval|Median
95925|NCT00848926|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to approximately 4 years|Participants with objective response among the intention to treat population||months||95% Confidence Interval|Median
95926|NCT00848926|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
95927|NCT00848926|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat||percent of participants||95% Confidence Interval|Number
95928|NCT00848783|Secondary|Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients||every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years||||||
95929|NCT00848783|Primary|Number of Patients With One-year Recurrence-free Survival|This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.|1 year|Based on intent-to-treat population.||participants|||Number
95930|NCT00848744|Secondary|The Subject's Medication Side Effect Profile Will be Assessed Using a Application Site Scale for Dryness, Scaling, Redness, and Stinging/Burning.||4 Weeks||||||
95931|NCT00848744|Primary|Physician Global Assessment|Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicyclic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).|28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).|Analysis was per protocol. Each subject received formulations A and B randomized to opposite sides of the face.||units on a scale||Standard Deviation|Mean
96255|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
95932|NCT00848549|Secondary|Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.|Weeks 0, 26, 52, 78 and 117|ITT Population||Score on a scale||Standard Deviation|Mean
95933|NCT00848549|Secondary|Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase|The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.|Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)|310 ITT Population||Percentage of Participants||95% Confidence Interval|Number
95934|NCT00848549|Secondary|Time to Drop-out Due to Adverse Event (AE)|"Adverse events in study subjects included any change in the subject’s condition.~This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF)."|Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)|310 ITT Population (33 participants were discontinued in the Zonisamide arm and 35 were discontinued in the Carbamazepine arm; these were the participants evaluated for this outcome)||Days||Standard Deviation|Mean
95935|NCT00848549|Secondary|Time to Drop-out Due to Lack of Efficacy|Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.|Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)|310 ITT Population (combined ITT Population from basecore study and extension phase). 24 participants were discontinued in each arm due to lack of efficacy; these were the participants that were evaluated in this outcome.||Days||Standard Deviation|Mean
95936|NCT00848549|Primary|Percentage of Participants Remaining in the Study at Each Visit|The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.|At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months|The Intent-to-Treat (ITT) Population is defined as all subjects who received at least one dose of investigational product(IP)||Percentage of Participants||95% Confidence Interval|Number
95937|NCT00848536|Primary|Mean Intraocular Pressure at 4:00 pm|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 4:00 pm)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.||mmHg||Standard Error|Least Squares Mean
95938|NCT00848536|Primary|Mean Intraocular Pressure at 11:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 11:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.||mmHg||Standard Error|Least Squares Mean
95939|NCT00848536|Primary|Mean Intraocular Pressure at 9:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient’s eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient’s worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 9:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.||mmHg||Standard Error|Least Squares Mean
95940|NCT00848510|Secondary|Progression-Free Survival (PFS) Time|PFS was defined as the time from first study drug intake until radiological progression (based on RECIST Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Subjects without event were censored on the date of last tumor assessment. Investigator read was the assessment of all imaging by the treating physician at the local trial site.|Time from first study drug intake to disease progression, death or last tumor assessment until end of trial visit (4 weeks after last dose administration)|The safety analysis set included all subjects who received at least one dose of IMP administration.||months||Full Range|Median
95941|NCT00848510|Primary|Whole Tumor Volume and Enhancing Tumor Volume|Tumor volume (three-dimensional measurement) and the enhancing fraction of the tumor, which provides a gross measure of the proportion of the tumor that has a measurable level of perfusion, were assessed using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||Cubic millimeter (mm^3)||Standard Deviation|Mean
96368|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
95944|NCT00848510|Secondary|Number of Subjects With Positive Binding Abituzumab Antibodies|Subjects were defined as abituzumab positive if at least one positive result of antibodies against abituzumab was observed. In all other cases, subjects were defined as abituzumab negative.|Day 1 of Weeks 1, 3, 5, 6, 7, 8, and week 11 and end of study (EOS) visit (4 weeks after last dose administration)|"The immunogenicity analysis set included all subjects who received at least one dose of study drug administration and provided sufficient data from the antibodies samples. 'N' (number of subjects analyzed) signifies the subjects evaluable for this outcome measure. n signifies the number of subjects evaluable for each time point, respectively."||Subjects|||Number
95945|NCT00848510|Secondary|Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score|The number of subjects who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.|Up to 4 weeks after last dose administration|The safety analysis set included all subjects who received at least one dose of IMP administration.||Subjects|||Number
95946|NCT00848510|Secondary|Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit|Tumor response was assessed by the Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria. Tumor response was defined as the presence of a “best overall response” of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions and/or normalization of serum levels of tumor markers. PR: At least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD of target lesions. The qualification of a CR or of a PR needed a confirmation by a second computed tomography (CT) scan at least 4 weeks after the first scan. Best overall response was derived programmatically as the best response recorded from the first investigation medicinal product administration until disease progression. Clinical benefit was defined as the presence of a “best overall response” of complete response or partial response or stable disease lasting at least 6 weeks.|Up to 4 years|The full analysis set included all subjects who received at least one dose of IMP administration. “N” signifies the total number of participants evaluable for this outcome measure. Same subjects may be reported in more than one category.||Subjects|||Number
95947|NCT00848510|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the initiation of the trial treatment until 30 days after last administration of trial treatment.|The safety analysis set included all subjects who received at least one dose of IMP administration.||Subjects|||Number
95948|NCT00848510|Primary|Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls|Volume transfer coefficient was defined as the volume transfer coefficient of contrast agent across the capillary wall, reflecting endothelial permeability and blood flow. Volumetric transfer coefficient was measured by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). DCE-MRI is a noninvasive quantitative method of investigating microvascular structure and function by tracking the pharmacokinetics of injected low molecular weight contrast agents as they pass through tumor vasculature.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.||min^-1||Standard Deviation|Mean
95949|NCT00848510|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|Toxicity was graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. A DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring during the first 4 weeks of treatment (that is, until the beginning of Week 5, with the exception of Grade 3 asymptomatic increase in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase [ALP]) returning to Baseline within 7 days.), at any dose level, for which a causal relationship to the investigative medicinal product could not be ruled out by the Investigator and/or the Sponsor.|Up to Week 4|Dose escalation analysis set included all subjects in the safety analysis set who experienced any DLT during the DLT observation period, regardless of the number of investigational medicinal product (IMP) administrations and subjects who received the IMP at Weeks 1, 3, and 5 for Cohort 1 and at Weeks 1 and 3 for all other cohorts.||Subjects|||Number
95950|NCT00848497|Secondary|Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.|EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better|Basline and 6 months|"Baseline = 98~5 months = 87"||units on a scale|||Number
95951|NCT00848497|Secondary|Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.|ADAM scores of one evaluated patient. ADAM is 10 questions (“yes” or “no” answers) and if you answer yes to question 1 or 7 or “yes” to any 3 questions you are said to test “positive” to the ADAM questionnaire.|Baseline and 6 months|Baseline = Positive 5 months = Positive||number of yes answers|||Number
95952|NCT00848497|Secondary|Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.|There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function|Baseline and 6 months|Baseline = 5 5 months = 6||units on a scale|||Number
95953|NCT00848497|Primary|Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.|SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED|Baseline and 6 months|Baseline = 0 5 months = 0||units on a scale|||Number
96038|NCT00848237|Primary|Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up|% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.|1 year|4011 subjects provided the answers||percentage of participants|||Number
95954|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the following tests: Identification Task and the Detection Task from the CogState Schizophrenia Battery and the Symbol Coding test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -287.15 and 287.15, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
95955|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score|The Working Memory Composite Score was comprised of the following tests: Two-Back Memory Task from the CogState Schizophrenia Battery and the Digit Sequencing test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -27.06 and 27.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
95956|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the following tests: Continuous Paired Associate Learning Task and One Card Learning Task from the CogState Schizophrenia Battery and the Verbal Memory test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -207.06 and 207.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
95957|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score|The Executive Functioning Composite Score was comprised of the following tests: Groton Maze Learning Task from the CogState Schizophrenia Battery and Tower of London, Semantic Fluency and Letter Fluency tests from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -253.4 and 253.4, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
95958|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score|CogState Schizophrenia Battery was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The composite score was comprised of 4 modules from the CogState Schizophrenia Battery: Identification Task, Detection Task, One Card Learning Task and Groton Maze Learning Task. Composite score was calculated by averaging all available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at 2 weeks of treatment for the endpoint are -347.5 and 347.5, respectively.|Baseline and week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
95959|NCT00848484|Primary|Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment|The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.||T-score based on normative data||95% Confidence Interval|Least Squares Mean
95960|NCT00848367|Secondary|Depression Symptoms|Early response to treatment is indicated by a reduction in depression symptoms measured by The Beck Depression Inventory II (BDI-II; Beck, Steer, & Brown, 1996). The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The range for this scale is 0-63. Higher scores represent more depressive symptoms. We included cases that were missing up to 8 missing items and calculated scores for participants with missing items by taking the weighted mean and multiplying by 21.|Pre and Post treatment, 6 months and 1 year|||units on a scale||Standard Deviation|Mean
95961|NCT00848367|Primary|Frequency of Binge Eating in the Past 28 Days||Pre and Post treatment, 6 months and 1 year|||days||Standard Deviation|Mean
95962|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95963|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95964|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95965|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95966|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95967|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95968|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95969|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
96039|NCT00848211|Primary|CD4+ T-cell Count|Change in CD4+ T-cell count from baseline|baseline and 20 weeks|||cells/mm3||Standard Error|Log Mean
96040|NCT00848211|Secondary|Determination of Anti-Tat Antibodies|Determination of change in anti-Tat antibody level|baseline and 16 weeks|||ng/mL||Full Range|Median
95970|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95971|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
95972|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95973|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
95974|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95975|NCT00848354|Secondary|Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mg / dL||Standard Error|Least Squares Mean
95976|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm/hour||Standard Deviation|Mean
95977|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm/hour||Standard Error|Least Squares Mean
96041|NCT00848211|Primary|HIV Viral Load|Change in HIV viral load from baseline|baseline and 20 weeks|||HIV RNA copies/mL||Standard Error|Log Mean
95978|NCT00848354|Secondary|Change From Baseline in Erosion Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
95979|NCT00848354|Secondary|Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
95980|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm||Standard Deviation|Mean
95981|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm||Standard Error|Least Squares Mean
95982|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm||Standard Deviation|Mean
95983|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm||Standard Error|Least Squares Mean
95984|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||mm||Standard Deviation|Mean
95985|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||mm||Standard Error|Least Squares Mean
95986|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||min||Standard Deviation|Mean
95987|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||min||Standard Error|Least Squares Mean
95988|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
96369|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
95989|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95990|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
95991|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95992|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
95993|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95994|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
95995|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
95996|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
95997|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
95998|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96370|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
95999|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96000|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96001|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96002|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96003|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96004|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96005|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96006|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:~DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6~DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96007|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:~DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6~DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96042|NCT00848198|Secondary|Referent Values for Ocular Surface Disease Index|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment and the index is calculated based on the responses given by the subject. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. A score of 0 confirms no dry eye symptoms are present, while a maximum of 100 indicates the maximum severity of symptoms experienced by subjects.|Single visit|||Score||Standard Deviation|Mean
96008|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96009|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96010|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:~DAS-value ≤3.7 and DAS-improvement from Baseline >0.6~DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96011|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:~DAS-value ≤3.7 and DAS-improvement from Baseline >0.6~DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96012|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96013|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96014|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96015|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96016|NCT00848354|Secondary|Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96043|NCT00848198|Secondary|Referent Values for Meibomian Gland Grading|Meibomian gland dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A score of 0 indicates full integrity of these glands while the maximum of 27, is used for severe damage.|Single visit|||Grade||Standard Deviation|Mean
96017|NCT00848354|Secondary|Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96018|NCT00848354|Secondary|Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
96019|NCT00848354|Secondary|Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
96020|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96021|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96022|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96023|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96024|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||percentage of participants|||Number
96034|NCT00848237|Primary|Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month|Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).|12 month|943 subjects completed both baseline and follow up quality of life life survey||units on a scale||Standard Deviation|Mean
96025|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||percentage of participants|||Number
96026|NCT00848354|Secondary|Summary of Changes in Therapy at the Beginning of Phase 2|The investigators were allowed to alter each participant`s therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. One participant was randomized to etanercept but received SSZ in Phase 1.||participants|||Number
96027|NCT00848354|Secondary|Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant`s general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).||units on a scale||Standard Deviation|Mean
96028|NCT00848354|Secondary|Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant`s general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||units on a scale||Standard Error|Least Squares Mean
96029|NCT00848354|Secondary|Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24|mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 24|Radiographic intent-to-treat (xITT) population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.||units on a scale||Standard Error|Least Squares Mean
96030|NCT00848354|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||Units on a scale||Standard Error|Least Squares Mean
96031|NCT00848354|Secondary|Change From Baseline in HAQ Score at Week 24|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.||Units on a scale||Standard Error|Least Squares Mean
96032|NCT00848354|Primary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. Last Observation carried forward (LOCF) method was used.||Percentage of participants|||Number
96033|NCT00848237|Primary|Adverse Event Incidence|Adverse and Serious Adverse event with Definite device relationship|12 month|||participants|||Number
96035|NCT00848237|Primary|Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up|Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface|1 year|||percentage of patients with SSIM|||Number
96044|NCT00848198|Secondary|Referent Values for Conjunctival Staining|Conjunctival staining is used to identify and evaluate dead or injured conjunctival cells. Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. A score of 0 indicates no damage of conjunctival cells, while the maximum for the most severe damage is 12.|Single visit|||Grade||Standard Deviation|Mean
96045|NCT00848198|Secondary|Referent Values for Corneal Staining|Corneal Staining is used to identify and evaluate ocular surface and corneal damages. It was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. A score of 0 indicates no damage of ocular surface/cornea, while the maximum for the most severe damage is 15.|Single visit|||Grade||Standard Deviation|Mean
96046|NCT00848198|Secondary|Referent Values for Tear Film Breakup Time||Single visit|||seconds||Standard Deviation|Mean
96047|NCT00848198|Secondary|Referent Values for Schirmer Test||Single visit|||mm||Standard Deviation|Mean
96048|NCT00848198|Secondary|Referent Values for Tear Osmolarity||Single visit|||mOsm/L||Standard Deviation|Mean
96049|NCT00848198|Primary|Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
96050|NCT00848198|Primary|Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27|Meibomian dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A cutoff threshold of grade 5/27 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
96051|NCT00848198|Primary|Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12|Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
96052|NCT00848198|Primary|Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15|Corneal Staining was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
96053|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds|Tear film breakup time was measured by instilling 5μL of a 2% sodium fluoresceine solution and calculating the average of three consecutive breakup times, manually determined with a stopwatch. The cutoff of <5 seconds was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, Meibomiann secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit|||participants|||Number
96054|NCT00848198|Primary|Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm|"A 5-minute Schirmer test was performed with sterile strips without anesthetic (Tear Flo). The cutoff threshold of <7mm was used to differentiating normal from mild subjects.~The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit|||participants|||Number
96055|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L|"Tear osmolarity was measured with a laboratory-on-a-chip, to simultaneously collect and analyze the electrical impedance of a 50 nL tear sample from the interior lateral meniscus (TearLab Osmolarity System). A cutoff threshold of more than 308 mOsm/L was used for differentiating normal from mild to moderate subjects.~The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit|||participants|||Number
96056|NCT00848172|Secondary|PK: AUC After OA|Area under the curve of PA plasma levels after administration|5 to 300 min post dose|||hr*ng/ml||Standard Deviation|Mean
96057|NCT00848172|Secondary|TMax Octanoic Acid|Time to plasma peak OA|between 5 and 300 min post dose|||min||Standard Deviation|Mean
96058|NCT00848172|Secondary|Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo|As described at the section for the primary outcome, normalized accelerometric tremor accelerometry was measured at other time-points to describe a time-course of effect. This stated secondary outcome compared normalized (baseline = 1) accelerometric at the last time-point 300 min post dose after OA vs Placebo. Ratios of tremor power at 300 min divided by tremor power at baseline used for outcome measure calculation.|300 min post dose|||ratio||Inter-Quartile Range|Median
96059|NCT00848172|Primary|Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition|Postural tremor was measured using accelerometry with a motion sensor (accelerometer) placed at the dorsum of each hand, and tremor recorded simultaneously with surface-electromyography of wrist flexors and extensors for 2 minutes at each time-point. The recording was repeated with 1 lbs weight added to each wrist, which was described to record the central tremor component. The primary outcome measure was defined as tremor power of the central tremor component (after the addition of weight) 80 minutes after administration, measured at the dominant hand, normalized to baseline (baseline = 1), and comparing octanoic acid vs. placebo. Ratio of tremor power at 80 min divided by tremor power at baseline used for outcome measure calculation.|80 min after administration of the study drug on day 1 and 2 of Visit 2|2 patients were excluded from primary outcome measure analysis because of one subject was withdrawn prior to drug administration due to an SAE, and one subject did not exhibit a central tremor component (primary measure), on the day of administration.||ratio||Inter-Quartile Range|Median
96060|NCT00848120|Secondary|Time to Onset of ACR20/50/70 Response|Time to onset of ACR 20/50/70 response was calculated as the number of weeks from the administration of the first dose of study drug until the date of first achievement of ACR 20/50/70 per criteria.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population||weeks||Inter-Quartile Range|Median
96061|NCT00848120|Secondary|Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 >2.6 and <3.2=low disease activity.|Week 24|ITT Population||percentage of participants|||Number
96062|NCT00848120|Secondary|Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 <2.6=remission.|Week 24|ITT Population||percentage of participants|||Number
96063|NCT00848120|Secondary|Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hour]) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
96064|NCT00848120|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participants response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the health status.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
96065|NCT00848120|Secondary|HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24|HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To calculate HAQ-DI the participant must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst).|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
96066|NCT00848120|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population||percentage of participants|||Number
96067|NCT00848120|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population||percentage of participants|||Number
96068|NCT00848120|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24|ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.|Week 24|ITT population||percentage of participants|||Number
96069|NCT00848107|Primary|Formation of New Ulcers|The number and percentage of subjects who developed new ulcers during the study were summarized.|18 months (or last study visit)|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||participants|||Number
96070|NCT00848107|Primary|Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|The total ulcer number includes all ulcers designated as “active”, “indeterminate”, or “new” for a given visit. The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment.|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||number of ulcers||Standard Deviation|Mean
96071|NCT00848107|Secondary|Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment|The CHFS score is derived from 18 validated questions that assess functional disability and handicap due to hand involvement in rheumatoid arthritis. Each answer is scored on a scale with possible integer responses of 0(without difficulty) to 5 (impossible). The CHFS score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS score values can range from 0 (least limitation) to 90 (most limitation), with improvements in function or reduction of limitation indicated a decreased score value. The mean change from study entry in CHFS scores at each scheduled assessment are summarized.|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||units on a scale||Standard Deviation|Mean
96072|NCT00848107|Primary|Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|Net ulcer burden at any given assessment was defined as the number of “new” or “active” ulcers at that assessment, plus the number of “indeterminate” ulcers at that assessment that had previously been classified as either “active” or “new” at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed using data obtained at each visit, if available, from all subjects enrolled in this study. Assessments performed after discontinuation of study drug were excluded from the summaries.||ulcers||Standard Deviation|Mean
96073|NCT00848107|Secondary|Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment|The SHAQ consists of 20 health assessment questionnaire questions with integer responses of 0 (without any difficulty) to 3 (unable to do), and five scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud’s Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with values ranging from 0.0 to 15.0 centimeters. The questions are divided into eight component domains: Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each domain score is calculated by summing the domain responses and dividing by the number of questions in that domain. Each VAS domain score is calculated by dividing the value in centimeters by 5. SHAQ component and VAS domain score ranges from 0 (least limitation) to 3 (most limitation). The aggregate SHAQ score is calculated by dividing the sum of all domain scores by 13, with a score ranging from 0 (least limitation) to 3 (most limitation).|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.||units on a scale||Standard Deviation|Mean
96074|NCT00848081|Secondary|Uroflowmetry (Qmax) Change From Baseline|Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).|Baseline, 12 Weeks|All randomized subjects with non-missing data.||milliliters per second||Standard Deviation|Mean
96075|NCT00848081|Secondary|Postvoid Residual Volume (PVR) Change From Baseline|Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.|Baseline, 12 Weeks|All randomized subjects who had non-missing baseline and endpoint data.||milliliters||Standard Deviation|Mean
96076|NCT00848081|Secondary|International Prostate Symptom Score (IPSS) Change From Baseline|Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data.||units on a scale||Standard Deviation|Mean
102262|NCT00795951|Primary|Diagnostic Performance: Thiuram Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
96077|NCT00848081|Secondary|Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit|A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.|Baseline through 12 Weeks|All randomized subjects in the analysis population with non-missing data.||Participants|||Number
96078|NCT00848081|Primary|Number of Men With Treatment-emergent Dizziness|The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.|Baseline through 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.||Participants|||Number
96079|NCT00848042|Secondary|Response in Targeted Tumors.||6 months|Data was not collected/analyzed|||||
96080|NCT00848042|Primary|Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration|Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion|up to 6 months|per protocol||participants|||Number
96081|NCT00848016|Secondary|Progression-free Survival|The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier.|From registration to progression or death, whichever occurs first, up to 2 years.|||months||95% Confidence Interval|Number
96082|NCT00848016|Secondary|Overall Survival|The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to date of last follow-up or death due to any cause, assessed up to 2 years|||months||95% Confidence Interval|Median
96083|NCT00848016|Primary|The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria|"In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
96084|NCT00847886|Secondary|Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15|Baseline was defined as pre-dose on Day 1.|Day 15|||Percent||Standard Deviation|Mean
96085|NCT00847886|Secondary|Half-life of LX3305 in Plasma in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.||hours||Standard Deviation|Mean
96086|NCT00847886|Secondary|Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.||hours||Full Range|Median
96087|NCT00847886|Secondary|Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.||ng/mL||Standard Deviation|Mean
96088|NCT00847886|Primary|Amount of 7-OH-MTX Excreted in the Urine||Day 15|||µg||Standard Deviation|Mean
96089|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of 7-OH-MTX||Day 15|||hours||Full Range|Median
96090|NCT00847886|Primary|7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration|7-OH-MTX is the primary metabolite of methotrexate.|Day 15|||ng/mL||Standard Deviation|Mean
96091|NCT00847886|Primary|Amount of Methotrexate Excreted in the Urine||Day 15|||µg||Standard Deviation|Mean
96092|NCT00847886|Primary|Half-life of Methotrexate in Plasma||Day 15|||hours||Standard Deviation|Mean
96093|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of Methotrexate||Day 15|||hours||Full Range|Median
96094|NCT00847886|Primary|Methotrexate Maximum Plasma Concentration||Day 15|||ng/mL||Standard Deviation|Mean
96095|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96096|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96371|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
96097|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96098|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96099|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96100|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96101|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96102|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96103|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96104|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96129|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96105|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96106|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96107|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.||units on a scale||Standard Deviation|Mean
96108|NCT00847808|Primary|Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.|Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period.|Week 3 through Week 6|Values are from the Full Analysis Set.||percent of participants|||Number
96109|NCT00847704|Secondary|Active Motion Test|Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)|||Seconds||Standard Deviation|Mean
96110|NCT00847704|Secondary|Strength Test|Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)|||Newton meters||Standard Deviation|Mean
96111|NCT00847704|Secondary|Spasticity (Modified Ashworth) Scale|Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||units on a scale||Standard Deviation|Mean
96112|NCT00847704|Secondary|Stroke Impact Scale|"The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:~Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100.~Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning."|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||units on a scale||Standard Deviation|Mean
96113|NCT00847704|Secondary|Timed 10-Meter Walk|Gait Assessment - Time|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||seconds||Standard Deviation|Mean
96114|NCT00847704|Primary|Fugl-Meyer Assessment of the Lower Extremity|Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up|||units on a scale||Standard Deviation|Mean
96115|NCT00847665|Secondary|Length of Mechanical Ventilation (MV)|Time from initiation to withdrawal of mechanical ventilation. Days|ICU length of stay|||days||Inter-Quartile Range|Median
96116|NCT00847665|Secondary|Workload of Nurses|Time actually spent to manual repositioning by nurses team, in minutes/day|icu length of stay|||minutes per day||Inter-Quartile Range|Median
96117|NCT00847665|Secondary|ICU Mortality|ICU mortality (number of death in ICU)|ICU length of stay (an average of 28 days)|||participants|||Number
96118|NCT00847665|Primary|Incidence of Pressure Ulcer (PU) Grade ≥ II|Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer|Intensive Care Unit (ICU) length of stay (days)|Intention to treat||participants|||Number
96119|NCT00847626|Secondary|Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||percentage of participants|||Number
96120|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the average of the 3 serial trough sitting clinic diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||percentage of participants|||Number
96121|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96122|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the average of the 3 serial trough sitting clinic systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||percentage of participants|||Number
96123|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96124|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96125|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96126|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96127|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96128|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96215|NCT00847301|Secondary|Volume of Wound Drainage (Post-operative)|Volume of Wound Drainage after surgery|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||ml||Standard Deviation|Mean
96130|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96131|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96132|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96133|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)|The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96134|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)|The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96135|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96136|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
96137|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12, 18, 24|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96138|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96139|NCT00847613|Other Pre-specified|Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.|||||
96140|NCT00847613|Other Pre-specified|Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.|||||
96216|NCT00847301|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings|Percentage of Patients With Major Extra-surgical Site Bleedings|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of Participants||95% Confidence Interval|Number
96141|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 9, 12, 15, 18, 21, 24|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.||mmHg||Standard Deviation|Mean
96142|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 1, 3, 6|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.||millimeters of mercury (mmHg)||Standard Deviation|Mean
96143|NCT00847613|Other Pre-specified|Association Between Genomic and Metabonomic Variation||Month 24||02/2013||||
96144|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96145|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96146|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96147|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96148|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96149|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96150|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96151|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96152|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96153|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96154|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96155|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96156|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96157|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||hours per day||Standard Deviation|Mean
96372|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population||Participants|||Number
96158|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||hours per day||Standard Deviation|Mean
96159|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||days||Standard Deviation|Mean
96160|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||days||Standard Deviation|Mean
96161|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||events||Standard Deviation|Mean
96162|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||events||Standard Deviation|Mean
96163|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96164|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family, friends or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96165|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96329|NCT00846287|Primary|Change in Total Ventilation Volume|"Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described:~The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation."|2 hours|Analysis per protocol.||Litres||Standard Deviation|Mean
96166|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96167|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96168|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96169|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96170|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96171|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.||participants|||Number
96172|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96192|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96173|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||participants|||Number
96174|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96175|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96176|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96177|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||mm||Standard Deviation|Mean
96178|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
96179|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||mm||Standard Deviation|Mean
96180|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
96181|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||mm||Standard Deviation|Mean
96182|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mm||Standard Deviation|Mean
96213|NCT00847405|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
96183|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96184|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96185|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Month 12 and 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for Month 24 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96186|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Baseline|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
96187|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).|||||
96188|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).|||||
96189|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
96190|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
96191|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 indicated low disease activity, >3.2 to 5.1 indicated moderate to high disease activity and <2.6 = remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.||units on a scale||Standard Deviation|Mean
102263|NCT00795951|Primary|Diagnostic Performance: Thimerosal|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
96193|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96194|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96195|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96196|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96197|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.||percentage of participants|||Number
96198|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96199|NCT00847613|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.||percentage of participants|||Number
96200|NCT00847613|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
96201|NCT00847613|Primary|Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Baseline, Month 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
96202|NCT00847613|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using Non-responder Imputation (NRI) method.||percentage of participants|||Number
96203|NCT00847587|Secondary|Crematocrit of Human Milk|Determination of creamatocrit is a simple method for estimating the fat & energy content of human milk based on the centrifugation of milk in a hematocrit centrifuge. The method for creamatocrit measurement was as described by Lucas et al (LucasA, GibbsJA, LysterRL, BaumJD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. BritMedJnl1978;1:1018-20)using a standard hematocrit centrifuge, standard hematocrit glass capillary tube, & vernier calipers. Measurements were performed in duplicate and the mean for each measurement used for analysis.|6 weeks postpartum|Both intent-to-treat and per-protocol analyses were performed. Per-protocol analysis is presented to demonstrate the more conservative analysis for the primary outcomes in a noninferiority study.||Percent creamatocrit||Standard Deviation|Mean
96204|NCT00847587|Primary|Time to Lactogenesis Stage II|The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, “Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby’s mouth, or gulping by the baby. ” If the response was positive, subjects were then asked, “When did your milk come in?” and the response recorded to the nearest hour.|5 days postpartum|||hours||Standard Deviation|Mean
96205|NCT00847561|Primary|Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)|"The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues.~This interview will be administered by a trained staff member and will utilize information from both parents and children.~This interview will be used to determine the presence or absence of an anxiety disorder for children in this study."|12 months post-treatment|||participants with anxiety diagnosis|||Number
96206|NCT00847535|Primary|Number of Participants That Experienced AMDC Product-related Adverse Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.~No adverse events reported during the study were adjudicated as AMDC product-related."|12 months|||participants|||Number
96207|NCT00847535|Primary|Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.~All injection procedure-related events self-resolved or were easily treated."|30 days|||Number of events|||Number
96208|NCT00847535|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.~All injection procedure-related events self-resolved or were easily treated."|30 days|Sixty-four patients underwent intrasphincteric injection of AMDC.||participants|||Number
96209|NCT00847535|Primary|Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.~All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment|||Number of events|||Number
96210|NCT00847535|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.~All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment|During the study, 66 patients underwent a total of 78 biopsies.||participants|||Number
96211|NCT00847509|Primary|[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan|The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.|3-5 weeks after the start of radiation or chemo radio therapy||||||
96212|NCT00847405|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
96217|NCT00847301|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of Participants||95% Confidence Interval|Number
96218|NCT00847301|Primary|Percentage of Patients With Major Bleeding Events (MBE)|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of participants||95% Confidence Interval|Number
96219|NCT00847301|Secondary|Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality|Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.||percentage of participants||95% Confidence Interval|Number
96220|NCT00847288|Secondary|Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year|||months||95% Confidence Interval|Median
96221|NCT00847288|Secondary|Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews|The binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.|1 year|||percentage of visits with action|Participants|95% Confidence Interval|Mean
96222|NCT00847288|Secondary|Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm|"There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score.~Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score."|1 year|"For each component, the subject needs to have baseline and 6 (or 12) month measurements to calculate the changes. Subjects included for the each component are as following:~Maintenance (or Confidence): 720 and 675 for monthly and quarterly arms at 6 mo, respectively, 640 and 588 at 12 mo. Management, 166 and 141 at 6 mo, 166 and 104 at 12 mo."||units on a scale||Standard Deviation|Mean
96223|NCT00847288|Primary|Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year|All patients enrolled in the study, who have eligible study device, signed inform consent, signed HIPAA, and have at least one OptiVol threshold crossing post the start date, were included in this analysis.||months||95% Confidence Interval|Median
96224|NCT00847210|Primary|Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|After 7 days of dosing.|All participants who had Vz/F estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.||L||Standard Deviation|Mean
96225|NCT00847210|Primary|Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.|After 7 days of dosing.|All participants who had λz estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.||1/hr||Standard Deviation|Mean
96226|NCT00847210|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter.|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.|After 7 days of dosing.|All participants who had CL/F estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.||liter/hr||Standard Deviation|Mean
96239|NCT00847145|Secondary|Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.||Percentages of Subjects||95% Confidence Interval|Number
96227|NCT00847210|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|After 7 days of dosing.|All participants who had T1/2 estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. No statistical tests were performed.||hours||Standard Deviation|Mean
96228|NCT00847210|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.|AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study).|After 7 days of dosing.|All participants who had AUC(0-24) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||ng*hr/mL/mg||Standard Deviation|Mean
96229|NCT00847210|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.|Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|After 7 days of dosing.|All participants who had AUC(0-tlqc) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||ng*hr/mL/mg||Standard Deviation|Mean
96230|NCT00847210|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|After 7 days of dosing.|All participants who had Cmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||ng/mL||Standard Deviation|Mean
96231|NCT00847210|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.|After 7 days of dosing.|All participants who had Tmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the pharmacokinetic (PK) analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.||hours||Standard Deviation|Mean
96232|NCT00847197|Secondary|Percent Change From Baseline in Triglycerides (mg/dL)||Baseline and 4 Weeks|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.||Percent Change||Standard Deviation|Mean
96233|NCT00847197|Primary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.||Percent Change||Standard Deviation|Mean
96234|NCT00847197|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.||Percent Change||Standard Deviation|Mean
96235|NCT00847145|Secondary|Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 8 to day 28 after MMRV vaccination.|Analysis performed on the Safety population.||Subjects|||Number
96236|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 1 to day 7 after MMRV vaccination.|Analysis performed on the Safety population.||Subjects|||Number
96237|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).|From day 1 to day 7 after each rMenB+MV NZ vaccination.|Analysis performed on the Safety population.||Subjects|||Number
96238|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.|From day 1 to day 7 after each rMenB+OMV NZ vaccination.|Analysis performed on the Safety population.||Subjects|||Number
96254|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
96240|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers|The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.|One month after the first dose and one month after the second dose.|The analysis was done on the SBA PP Catch-up population.||IU/mL||95% Confidence Interval|Geometric Mean
96241|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.||IU/mL||95% Confidence Interval|Geometric Mean
96242|NCT00847145|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.|One month after the second dose.|||Percentages of Subjects||95% Confidence Interval|Number
96243|NCT00847145|Secondary|SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.|One month after the second dose.|The analysis was done on the SBA PP Catch-up population.||Titers||95% Confidence Interval|Geometric Mean
96244|NCT00847145|Secondary|Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)|The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.|one month after booster (fourth) dose vaccination and pre-fourth dose vaccination|This analysis was done on the PP population.||Titers||95% Confidence Interval|Geometric Mean
96245|NCT00847145|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)|Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|One month post vaccination and pe-booster (fourth) dose vaccination|The analysis was done on PP population.||Percentages of subjects||95% Confidence Interval|Number
96246|NCT00847145|Secondary|Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)|The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|one month after third vaccination and pre dose fourth (booster) vaccination|||Titers||95% Confidence Interval|Geometric Mean
96247|NCT00847145|Secondary|The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after booster (fourth) vaccination.|This analysis was done on PP population.||Titers||95% Confidence Interval|Geometric Mean
96248|NCT00847145|Secondary|Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination|"Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.~The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection."|one month after booster (fourth) dose|This analysis was done on Per Protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
96249|NCT00847145|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.|one month after the booster (fourth) dose|The analysis was done on Per Protocol (PP) population – subjects who received all doses of vaccine in parent & present study, provided evaluable serum samples at 1 month after booster dose or 1 month after 2nd dose, blood draw at 1 month after 3rd injection at 6 months in parent & visit 1 blood draw in present study, had no major protocol violation||Percentages of subjects||95% Confidence Interval|Number
96250|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
96251|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
96252|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
96253|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks|||Scores on a scale||Standard Error|Mean
96256|NCT00847015|Secondary|The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.|The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.|2 years|||months||95% Confidence Interval|Median
96257|NCT00847015|Secondary|The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|is defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years|||percentage of participants||95% Confidence Interval|Number
96258|NCT00847015|Primary|The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years|||percentage of participants||95% Confidence Interval|Number
96259|NCT00847002|Secondary|Reduction in Leg Volume||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.|||||
96260|NCT00847002|Primary|Wound Healing||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.|||||
96261|NCT00846885|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
96262|NCT00846885|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
96263|NCT00846885|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
96264|NCT00846846|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.|Total death and and number of patients with all non-fatal myocardial infarction. Cardiac death and number of patients with all non-fatal myocardial infarction. Total death and number of patients with large non-fatal myocardial infarction. Cardiac death and number of patients with large non-fatal myocardial infarction.|3 years|Main secondary endpoint results for the ITT population are similar to the primary endpoint analysis, a total of nine hundred and forty seven (947) ITT patients had sufficient follow-up or an event to be included in the main secondary endpoint analyses.||percentage of participants||95% Confidence Interval|Number
96265|NCT00846846|Primary|To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation|The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.|3 years|Of the one thousand and eighteen (1018) ITT patients, a total of nine hundred and forty seven (947) patients were included in the primary endpoint analysis. These patients had at least 1050 days of follow-up or had experienced stent thrombosis prior to 1080 days.||percentage of participants||95% Confidence Interval|Number
96266|NCT00846807|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||Percentage of participants||95% Confidence Interval|Number
96267|NCT00846807|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||ml||Standard Deviation|Mean
96268|NCT00846807|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||Percentage of participants||95% Confidence Interval|Number
96269|NCT00846807|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS||Percentage of participants||95% Confidence Interval|Number
96270|NCT00846807|Primary|Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated Set (TS) comprises all patients who completed the surgery and received at least 1 dose of dabigatran etexilate.||Percentage of participants||95% Confidence Interval|Number
96271|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 24 Hours|Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.~This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."||percent||Geometric Coefficient of Variation|Geometric Mean
96272|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 12 Hours|"Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.~Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||percent||Geometric Coefficient of Variation|Geometric Mean
96273|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 24 Hours|Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.~This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."||ng||Geometric Coefficient of Variation|Geometric Mean
96274|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 12 Hours|"Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.~Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||ng||Geometric Coefficient of Variation|Geometric Mean
96275|NCT00846768|Secondary|Pharmacokinetics (PK): Concentration of the Analyte in Plasma Measured at 0.167 Hours Post Dosing at Steady State|Steady state concentration of the analyte in plasma measured at 0.167 hours post dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. In the Olo 2 mcg Bid Arm, there were only 14 patients with values within the validated concentration range."||pg/mL||Geometric Coefficient of Variation|Geometric Mean
96276|NCT00846768|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|3 weeks|Treated set.||percentage of participants|||Number
96277|NCT00846768|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96278|NCT00846768|Secondary|Peak FVC (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96279|NCT00846768|Secondary|FVC Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1, 0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96280|NCT00846768|Secondary|FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96281|NCT00846768|Secondary|FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96373|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 h and 24 h after injection|Intent-to-treat population||Participants|||Number
96282|NCT00846768|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96283|NCT00846768|Secondary|Peak FEV1 (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96284|NCT00846768|Secondary|FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96285|NCT00846768|Primary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96286|NCT00846768|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.||Liter||Standard Error|Least Squares Mean
96287|NCT00846651|Secondary|Incidence of Maternal Nausea and Vomiting||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||percentage of participants|||Number
96288|NCT00846651|Secondary|APGAR Scores|The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).|Apgar scores were assessed at 1 amd 5 min after delivery of the baby|||units on a scale||Full Range|Median
96289|NCT00846651|Secondary|Fetal Cord Blood pH||delivery of the baby||||||
96290|NCT00846651|Secondary|Incidence of Maternal Bradycardia||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||percentage of participants|||Number
96291|NCT00846651|Secondary|Dosage of Phenylephrine Used||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||mcg of phenylephrine||Standard Deviation|Mean
96292|NCT00846651|Primary|Incidence of Maternal Hypotension||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby|||percentage of participants|||Number
96293|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
96294|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
96295|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
96296|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
96297|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
96298|NCT00846586|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
96299|NCT00846573|Primary|Hyperpolarized Helium-3 MR Images|We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.|15 second breath-hold|We recruited participants of each category until we were satisfied with the images we obtained.||participants|||Number
96300|NCT00846547|Primary|Irritability Subscale of the Aberrant Behavior Checklist, Community Version|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|At 8 weeks during the treatment period|||Points on a scale||Standard Error|Least Squares Mean
96301|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||After 6 Weeks (post treatment)|The number of participants who completed the study were analyzed||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
96302|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||At baseline (before treatment)|The number of participants who completed the study were analyzed||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
96303|NCT00846495|Secondary|Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine|Average cost of study medication taken by each subject. Measured in dollars.|Treatment Months 1 and 2|||Dollars (US)||Standard Deviation|Mean
96304|NCT00846495|Secondary|Adverse Events Associated With Study Medications|Includes Adverse Events at or above 5% frequency per group.|Treatment Months 1 and 2|||Adverse Events|Participants||Number
96305|NCT00846495|Secondary|Participant Satisfaction With Study Medications|"Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.~Participants completed the PPMQ 24 hours following each first dose of frovatriptan."|Treatment Month 2|||Score on a Scale||Standard Deviation|Mean
96306|NCT00846495|Secondary|Quality of Life in Subjects Utilizing Each Treatment Paradigm|Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.|Randomization, End of Treatment Month 1, End of Treatment Month 2|||Score on a Scale||Standard Deviation|Mean
96307|NCT00846495|Secondary|Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm|Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2|2 Months|||Participants|||Number
96308|NCT00846495|Secondary|Number of Headache Days Each Month Following Initiation of Treatment With Study Medication|Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication|2 Months|Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.||Headache Days|Participants|Standard Deviation|Mean
96309|NCT00846495|Primary|Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine|Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine|Treatment Month 2|||Headache Days||Standard Deviation|Mean
96374|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population||Participants|||Number
96310|NCT00846495|Primary|Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate|Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2|Treatment Month 2|Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.||Migraine attacks|Participants|Standard Deviation|Mean
96311|NCT00846391|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values.~Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored."|Baseline and Week 4|The analysis population included all patients with a baseline value and Week 4 value for this outcome.||mg/dL||Standard Deviation|Mean
96312|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic AND Systolic Blood Pressure Response, Defined as <140/90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease (CKD) or <130/80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve both a clinic diastolic blood pressure response, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) or <130/80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||percentage of participants|||Number
96313|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as Defined as <90 mm Hg for Participants Without Diabetes or CKD or <80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic diastolic blood pressure response, defined as defined as <90 mm Hg for participants without diabetes or CKD or <80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||percentage of participants|||Number
96314|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as <140 mm Hg for Participants Without Diabetes or CKD or <130 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic systolic blood pressure response, defined as <140 mm Hg for participants without diabetes or CKD or <130 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||percentage of participants|||Number
96315|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96316|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean Systolic Blood Pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96317|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the nighttime, while asleep (12am to 6am) mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96318|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the nighttime, while asleep (12am to 6am) mean systolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96319|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean diastolic blood pressure measured at Week 4 and Week 8relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96320|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean systolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96321|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 24-hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. . Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average of measurements collected over the subsequent 24 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96322|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-hour mean systolic blood pressure at week4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96323|NCT00846365|Secondary|Change From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96324|NCT00846365|Secondary|Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Error|Least Squares Mean
96325|NCT00846365|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 4 and week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Deviation|Least Squares Mean
96326|NCT00846365|Secondary|Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 4 relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 4.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.||mmHg||Standard Deviation|Least Squares Mean
96327|NCT00846365|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.||mmHg||Standard Deviation|Least Squares Mean
96328|NCT00846287|Secondary|Change in FEV1|Spirometry was taken which measures FEV1 (in Litres), before administration of an intervention and again 2 hours after administration of an intervention. The change in FEV1 (Litres) from pre-nebulizer inhalation to post-nebulizer inhalation was compared.|2 hours|As per protocol||Litres||Standard Deviation|Median
96375|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population||Participants|||Number
96330|NCT00846066|Primary|Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months|The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%|At baseline and 6 months|Analysis per protocol. Subjects dropped from analysis because charts not available within the time frame of the study and incomplete data.||Percent change||Standard Deviation|Mean
96331|NCT00846066|Primary|Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months|"Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the agree and strongly agree responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months|||Percent change||Standard Deviation|Mean
96332|NCT00846066|Primary|Percent Change From Baseline in Confidence at 4 Months|"Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of very confident was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months|Only completed paired (pre/post intervention) surveys were analyzed||Percent change.||Standard Deviation|Mean
96333|NCT00846066|Primary|Mean Percentage of Correct Skills|Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups|3 months after Hands-on Training (HOT)|||Percentage of correct skills||Standard Deviation|Mean
96334|NCT00846027|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.||Months||95% Confidence Interval|Median
96335|NCT00846027|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.||Months||95% Confidence Interval|Median
96336|NCT00846027|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
96337|NCT00846027|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.||Months||95% Confidence Interval|Median
96338|NCT00845975|Secondary|Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion|The Trait portion of the State-Trait Anxiety Inventory (STAI-T) evaluates an individual’s tendency to get anxious and how they respond to stress. The STAI-T has 20 items rated on a 4-point frequency of occurrence scale of 1=Almost Never, 2=Sometimes, 3=Moderately So, and 4=Very Much So. The individual scores are summed to get the total STAI-T score. The higher the total score, the more anxious the individual, and the lower the total score, the less anxious the individual. Change in STAI-T score is calculated as the STAI-T score at 4 weeks after baseline evaluation minus the STAI-T score at baseline. A positive (+) change in STAI-T score indicates that the anxiety has worsened. A negative (-) change in STAI-T score indicates the depression has lessened. A change in STAI-T score of -8 or greater indicates a meaningful lessening of anxiety and is positive for study success.|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
96339|NCT00845975|Secondary|Beck Depression Inventory-II (BDI-II)|The Beck Depression Inventory®-II (BDI®–II) is a 21-item questionnaire used to assess depression. Most items are rated on a 4-point scale from 0 to 3, and a few items are rated on a 7-point scale. Individual item scores are added to get a total score from 0 to 63. The higher the total score, the more severe the depression, and the lower the total score, the less severe the depression. Change in BDI®–II score is calculated as the BDI®–II score 4 weeks after baseline evaluation minus the BDI®–II score at baseline. A positive (+) change in BDI®–II score indicates that the depression has worsened. A negative (-) change in BDI®–II score indicates the depression has lessened. A change in BDI®–II score of -6 or greater indicates a meaningful lessening of depression and is positive for study success.|baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
96353|NCT00845832|Secondary|Change From Baseline to Week 48 in SJC and TJC|An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints).|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
96526|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
96340|NCT00845975|Primary|Total Score on the Tinnitus Handicap Inventory (THI).|The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual’s life. Each question is responded to as ‘yes’ (4 points); ‘sometimes’ (2 points) or ‘no’ (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual’s life. Change in total THI score is calculated as total THI score after the one week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual’s everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual’s everyday life has improved (lessened). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual’s life and is positive for study success.|baseline and one week|||units on a scale||Standard Deviation|Mean
96341|NCT00845897|Secondary|Barefoot Plantar Pressure|Novel emed pressure platform was used for data collection. A two-step method of data collection was used and a minimum of two trials of each foot were recorded. The plantar pressure map was divided into 3 horizontal masks using Percent Mask software and peak plantar pressure was determined for the forefoot region. Results are expressed in N/cm^2.|pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing|||Peak Plantar Pressure (N/cm^2) changes||Standard Deviation|Mean
96342|NCT00845897|Primary|Plantar Flexor Muscle Strength|Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing & Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.|Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing|||Plantar Flexor Torque (Nm)||Standard Deviation|Mean
96343|NCT00845858|Other Pre-specified|The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo.~The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).~Nausea (feeling sick to your stomach as if you were going to vomit or throw up)~Early satiety (not able to finish a normal sized meal)~Bloating (feeling like you need to loosen clothes)~Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.~A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks|||units on a scale||Standard Deviation|Mean
96344|NCT00845858|Primary|The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.~The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).~Nausea (feeling sick to your stomach as if you were going to vomit or throw up)~Early satiety (not able to finish a normal sized meal)~Bloating (feeling like you need to loosen clothes)~Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.~A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks|ITT||units on a scale||Standard Deviation|Mean
96345|NCT00845845|Secondary|Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.|||||
96346|NCT00845845|Primary|Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.|||||
96347|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant’s Assessment of Pain|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
96348|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant’s Global Assessment of Disease Activity|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
96349|NCT00845832|Secondary|Change From Baseline to Week 48 in Physician’s Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
96350|NCT00845832|Secondary|Change From Baseline to Week 48 in ESR|ESR is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
96351|NCT00845832|Secondary|Change From Baseline to Week 48 in C-Reactive Protein (CRP)|CRP is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
96352|NCT00845832|Secondary|Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ)|The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments.|Baseline and Week 48|Data were not collected because the study was terminated early.|||||
96354|NCT00845832|Secondary|Simplified Disease Activity Index (SDAI) Scores|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48|Data were not collected because the study was terminated early.|||||
96355|NCT00845832|Secondary|Clinical Disease Activity Index Scores|"The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10~Where:~SJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant’s global assessment of disease activity; EGA = evaluator’s (physician’s) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity >22; moderate disease activity >10 and ≤22; LDA >2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.||units on a scale||Standard Deviation|Mean
96356|NCT00845832|Secondary|Change From Baseline in DAS28-ESR|"The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).~DAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 * √TJC)+(0.28 * √SJC)+(0.70 * ln(ESR))+(0.014 * GH).~No imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS."|Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; number (n) = number of participants analyzed at the specified visit.||units on a scale||Standard Deviation|Mean
96357|NCT00845832|Secondary|Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or DAS28-ESR >5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 16|ITT Population; No imputation used for TJC, SJC, ESR, and PtGA. EULAR response was set to missing when the DAS28 score was missing.||percentage of participants|||Number
96358|NCT00845832|Secondary|Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR|The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (<) 2.6|Week 16|ITT Population; LOCF used for TJC, ESR, and PtGA. If the DAS28-ESR value was missing then remission or LDA was missing.||percentage of participants|||Number
96359|NCT00845832|Primary|Percentage of Participants Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)|"The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC [28 joints]), Swollen Joint Count (SJC [28 joints]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2.~DAS28-ESR equals (=) (0.56 times (*) (square root)√ TJC plus (+) (0.28 * √ SJC + (0.70 * ln(ESR))+(0.014 * (Global Health) GH)~Where:~TJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant’s global assessment of disease activity ln = natural log"|Week 16|Intent-to-Treat (ITT) Population: all randomized participants who received any part of an infusion of study medication. Last observation carried forward (LOCF) used for TJC and SJC, ESR and PtGA. If DAS28-ESR value was missing LDA was missing.||percentage of participants|||Number
96360|NCT00845728|Secondary|Rate of COPD Exacerbations|COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.|52 weeks|Per-Protocol Set for Exacerbations (PPS-E). This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.||Exacerbations per patient per year|||Number
96361|NCT00845728|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1).|The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.|12 weeks|Per-Protocol Set for Spirometry (PPS-S) This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.||Liters||Standard Error|Least Squares Mean
96362|NCT00845702|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared|1 to 7 days|The study has been prematurely terminated, and the planned analyses were not done|||||
96376|NCT00845663|Secondary|Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection|Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).|Immediately after injection and 1 hour after injection|Intent-to-treat population||Units on a scale||Standard Deviation|Mean
96377|NCT00845663|Secondary|Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||Participants|||Number
96378|NCT00845663|Secondary|Apparent Volume of Distribution (Vz/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||L||Full Range|Geometric Mean
96379|NCT00845663|Secondary|Apparent Total Body Clearance (CL/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||mL/day||Full Range|Geometric Mean
96380|NCT00845663|Secondary|Time Corresponding to Cmax (Tmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
96381|NCT00845663|Secondary|Apparent Terminal Elimination Half-life (t1/2)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
96382|NCT00845663|Secondary|Apparent Terminal Elimination Rate Constant (λz)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||1/day||Standard Deviation|Mean
96383|NCT00845663|Secondary|Lowest Quantifiable Concentration Time (LQCT)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
96384|NCT00845663|Secondary|Time Point Where Log-linear Elimination Phase Begins (TLIN)|TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.|After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||days||Full Range|Median
96385|NCT00845663|Primary|Maximum Plasma Concentration (Cmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||microgram/mL||Full Range|Geometric Mean
96386|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||microgram*day/mL||Full Range|Geometric Mean
96387|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population||microgram *day/mL||Full Range|Geometric Mean
96388|NCT00845429|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.|"Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.~Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
96389|NCT00845429|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.|"Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.~Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21."|Day 21 post-vaccination|Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population.||Percentage of Participants|||Number
96390|NCT00845429|Primary|Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.|Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)|Day 21 post-vaccination|Seroprotection was assessed in the full analysis set population.||Percentage of Participants|||Number
96391|NCT00845429|Primary|Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.||Days 0 and 21 post-vaccination|Geometric mean titers were assessed in the full analysis set population.||Titers||95% Confidence Interval|Geometric Mean
96392|NCT00845195|Primary|Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
96393|NCT00845195|Primary|Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
96394|NCT00845195|Primary|Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
96523|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96395|NCT00845195|Primary|Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.||Units on a scale||Standard Deviation|Mean
96396|NCT00845182|Primary|HbA1c|change in HbA1c was measured before and after treatment in three groups|baseline and 6 months|There was a greater improvement in HbA1c from baseline after combined treatment with Pioglitazone and Exenatide when compared with either therapy alone.||percent point decrease from baseline||Standard Deviation|Mean
96397|NCT00845182|Secondary|Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatide on • Insulin Sensitivity • Inflammatory Cytokines • Glucagon and Free Fatty Acids • Plasma Lipids|"Effect pioglitazone, exenatide, and pioglitazone plus exenatide on~Insulin sensitivity~Inflammatory cytokines~glucagon and free fatty acids~plasma lipids"|6 months||11/2016||||
96398|NCT00845182|Primary|Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight|Effect of Pioglitazone, Exenatide and combined Pioglitazone and Exenatide on body weight and beta cell function|baseline and 6 months|we analyzed the weight at the end of study completion||kg||Standard Deviation|Mean
96399|NCT00845130|Primary|Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier|Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.|2 hour post infusion|Data from one healthy subject were not usable due to subject's movement during MRI scan.||µmol/g tissue||Standard Deviation|Mean
96400|NCT00845130|Primary|Concentration of Vitamin C in Type 2 Diabetic Patients.|Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.|Pre-Vitamin C infusion|Determine cerebral concentrations of vitamin C. Data from one healthy subject were not usable due to subject's movement during MRI scan.||umol/g tissue||Standard Deviation|Mean
96401|NCT00845065|Secondary|Mean Log Change From Baseline to TW 4 in Viral Load by Visit|HCV-RNA levels were quantified using the Roche Cobas Taqman 1.0 assay; lower limit of detection of 15 international units [IU]/mL. Changes in HCV-RNA IU/ml were expressed on a log10 scale.|From Baseline to TW 4|FAS Population||log10 (IU/mL)||Standard Deviation|Mean
96402|NCT00845065|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12||Follow-up Week 12|FAS Population||Participants|||Number
96403|NCT00845065|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR|EVR was defined as the time to the first undectectable HCV-RNA result at Treatment Week (TW) 2, 4, 8, or 12. Participants with a detectable, but not quantifiable HCV-RNA result at TW 12 may have undergone retesting. Participants with a detectable result on retesting were to be discontinued per the 12-week futility rule. Participants with an undetectable result on retesting were allowed to continue on treatment, and the detectable but not quantifiable result was to be considered a false positive.|Day 1 to Treatment Week 12|FAS Population||Percentage of Participants|||Number
96404|NCT00845065|Secondary|SVR Rate in the Modified Intent-to-Treat (mITT) Population|SVR rate was the percentage of participants treated with at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included in the mITT population.|Follow-up Week 24|mITT Population: all randomized participants who received at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included. FU W12 value was LOCF, if last SVR value at or after FU W24 was not available.||Percentage of Participants|||Number
96405|NCT00845065|Primary|Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.|SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).|Follow-up Week 24|FAS Population: all randomized participants who received at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo). Follow-up (FU) Week (W) 12 value was Last Observation Carried Forward (LOCF), if last SVR value at or after FU W24 was not available.||Percentage of Participants|||Number
96406|NCT00845000|Secondary|Mean Peak Walking Speed|Walking speed assessment began with the participant being seated in an armless chair. Then while being timed, the participant stood up with their arms crossed on their chest and walked 6 meters, turned around, returned to the chair and sat. Timing was stopped when the participant’s buttocks hit the chair and the total time was recorded. If the participant could not arise in 60 seconds, 60 seconds was entered in this line of the report form and the participant was tested again but allowed to push off to get out of the chair. Sixty seconds was the maximum time allowed to complete the walking assessment, thus 60 seconds was recorded as the time if they could not complete the task within this time limit. Walking speed was assessed at Hours 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7.0 and 8. The peak walking speed was recorded for each participant regardless of what timepoint the score was achieved. The mean peak walking speed was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||Seconds||Standard Deviation|Mean
96418|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (0-4 year old version). Parent-rated questionnaire that focuses on child's pain and parent's worry. Scores range from 5-24, with a higher score indicative of worse outcomes. Change in scores was measured from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
96524|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
96407|NCT00845000|Secondary|Mean Peak Tremor Score|Tremor was scored on a scale of 0 (absent), 1 (mild, 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse tremor observed during the time spent with participant while taking other study measurements(vital signs, drawing samples, performing the tapping and walking tasks). Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The tremor score was the sum of scores for seven body parts. The peak tremor score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating more effects of the tremors. The mean peak tremor score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||Score on a scale||Standard Deviation|Mean
96408|NCT00845000|Secondary|Mean Peak Finger Tapping Score|Tapping was measured with two manual counters with keys that were depressed to register a count. The participant alternately tapped each counter using the index finger of the more affected hand for 60 seconds and was not allowed to use more than one finger to tap. The participant was instructed to tap as rapidly as possible while being timed for 60 seconds. The counts were recorded for the two counters at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The peak tapping score was recorded for each participant regardless of what timepoint the score was achieved. The mean peak finger tapping score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||taps per 60 seconds||Standard Deviation|Mean
96409|NCT00845000|Primary|Mean Peak Dyskinesia Score|Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.||Score on a scale||Standard Deviation|Mean
96410|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (5-18 Year Old Version) is a 3-item questionnaire with scores ranging from 0-18. A higher score is indicative of worse outcomes. Used for five year olds in the study. Change in scores were observed from baseline to six month follow-up.|baseline and six month follow-up|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
96411|NCT00844896|Primary|DEF Participation|Outcomes in this measure were quantified by the number of participants in either intervention (DEF-only or COPE+DEF). During the study, DEF intervention was part of the standard of care for all patients at Shriners Hospitals for Children-Boston and thus every participant in this study had been evaluated using DEF to determine distress, emotional and family support.|Baseline|Intentional to treat (ITT)||participants|||Number
96412|NCT00844896|Primary|Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months|Stanford Acute Stress Reaction Questionnaire is a 31-question self-report measure for acute stress in parents. Scores range from 0-155 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
96413|NCT00844896|Primary|Change From Baseline in Hospital Emotional Support Form From Six Months|Hospital Emotional Support Form is a 12-question form that rates parents/caregivers need for in-hospital emotional support. Scores range from 11-24, with a lower score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
96414|NCT00844896|Primary|Change From Baseline in PTSD Semi-Structured Interview at Six Months|Posttraumatic Stress Disorder Semi-Structured Interview is based on DSM-IV criteria, with a higher score indicative of increased symptoms of PTSD. The total rating was scored from 19 questions in three clusters of symptoms, with a score range of 0-38. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
96415|NCT00844896|Primary|Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month|Child Stress Reaction Checklist Short Form is a 9-item parent-rated checklist. Scores range from 0-18 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
96416|NCT00844896|Primary|Change From Baseline in Parenting Stress Index at Six Months|Parenting Stress Index is a 12-item parent-rated questionnaire which employs a 1-5 Likert scale. Scores range from 12-60, with a lower score indicative of worse outcomes and a cutoff of 15. Change in scores were observed from baseline to six month follow-up.|Baseline and six month follow-up|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
96417|NCT00844896|Primary|Change From Baseline in Pediatric Symptom Checklist at Six Months|Pediatric Symptom Checklist is an 18-item psychosocial checklist in which symptoms are rated from 0 (never) to 2 (often) and the last question is rated as yes or no (0 or 1). Items are summed and the score can range from 0-35, with a higher score indicative of more symptoms and a worse outcome. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)||units on a scale||Standard Deviation|Mean
96525|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
96419|NCT00844857|Other Pre-specified|Change From Baseline in Electrocardiogram (ECG) QTcF Interval Up to Week 8|QTcF is defined as ECG QT interval corrected for heart rate using the Fridericia correction factor.|Baseline, Week 8|Population analyzed M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and QTcF at baseline and at least 1 post-baseline measurement; LOCF.||millisecond (msec)||Standard Error|Least Squares Mean
96420|NCT00844857|Other Pre-specified|Change From Baseline in Prolactin Up to Week 8|Prolactin LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and prolactin at baseline and at least 1 post-baseline measurement; LOCF.||microgram/Liter (μg/L)||Standard Error|Least Squares Mean
96421|NCT00844857|Other Pre-specified|Change From Baseline in Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) Up to Week 8|ALT/SGPT LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ALT/SGPT at baseline and at least 1 post-baseline measurement; LOCF.||units/Liter (U/L)||Standard Deviation|Least Squares Mean
96422|NCT00844857|Other Pre-specified|Change From Baseline in Fasting Metabolic Parameters Up to Week 8|Fasting glucose, fasting cholesterol and fasting triglycerides. LS means were adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and fasting glucose, cholesterol and triglycerides at baseline and at least 1 post-baseline measurement; LOCF.||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
96423|NCT00844857|Other Pre-specified|Change From Baseline in Weight Up to Week 8|Weight LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and weight at baseline and at least 1 post-baseline measurement; LOCF.||kilogram (kg)||Standard Error|Least Squares Mean
96424|NCT00844857|Other Pre-specified|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Kid and Kiddo Combined Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Kid-KINDL was administered to ages 8-11 and Kiddo-KINDL to ages 12-16. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and had KINDL Kid and Kiddo results at baseline and at least 1 post-baseline measurement. Due to small number of 10- and 11-year olds results from the 2 versions were pooled; LOCF.||units on a scale||Standard Error|Least Squares Mean
96425|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Dyskinesia Up to Week 8|Dyskinesia was measured using the Abnormal Involuntary Movement Scale (AIMS) a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a patient. Total score (0-40) is obtained by adding the scores of the first 10 items. An abnormal result is defined as having a score ≥3 for at least 1 of the first 7 items or a score ≥2 for at least two of the first 7 items.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
96426|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Parkinsonism Up to Week 8|Parkinsonism was measured using the Simpson-Angus Scale with a total scores range from 0 to 40. A score > 3 was considered abnormal. Simpson-Angus Scale consists of 10 items, each rated on a 5-point scale, 0 (complete absence of the condition) to 4 (presence of the condition in extreme form).|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
96427|NCT00844857|Secondary|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and KINDL Parent Scale at baseline and at least 1 post-baseline measurement; LOCF.||units on a scale||Standard Error|Least Squares Mean
96428|NCT00844857|Secondary|Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8|Attention Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS-IV-PI): Investigator Administered and Scored measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Scores range: 0 to 54. The LS mean was adjusted for baseline and treatment.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ADHDRS-IV-PI results at baseline and at least 1 post-baseline measurement; LOCF.||units on a scale||Standard Error|Least Squares Mean
96429|NCT00844857|Secondary|Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8|Worsening of mania was defined as YMRS score of ≥20 and a CGI severity of mania score of ≥ 5 at the same visit. The YMRS is an 11-item scale measuring severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) with remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. CGI measures severity of the participant's overall severity of bipolar symptoms and scores range from 1 (normal) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites with YMRS and CGI total scores at baseline and at least 1 post-baseline measurement; LOCF.||percentage of participants|||Number
96430|NCT00844857|Secondary|Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8|"Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Percentage of participants with suicidal ideation, behavior, and acts are provided. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
96431|NCT00844857|Secondary|Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8|Akathisia was measured using the Barnes Akathisia Rating Scale where the global scores range from 0 (absent) to 5 (severe) and a score ≥ 2 is considered abnormal.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites; LOCF.||percentage of participants|||Number
96432|NCT00844857|Secondary|Change From Baseline in the CDRS-R Total Score Up to Week 8|CDRS-R Total score measure the presence and severity of depression in children and consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Total scores range from 17 to 113. In general, scores < 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had CDRS-R total scores at baseline and at least 1 post-baseline measurement; LOCF.||units on a scale||Standard Error|Least Squares Mean
96433|NCT00844857|Secondary|Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8|CGI-BP measures severity of illness for bipolar illness. Scores range: 1 (normal, not ill at all) to 7 (among the most extremely ill patients). LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had CGI-BP total scores at baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
96434|NCT00844857|Secondary|Change From Baseline in the YMRS Total Score at Week 8|The YMRS is an 11-item scale measuring the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total scores ranges: 0 to 60. LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had YMRS total scores with a baseline and at least 1 post-baseline measurement.||units on a scale||Standard Error|Least Squares Mean
96435|NCT00844857|Secondary|Percentage of Participants in Each Improvement Category Up to Week 8|CDRS-R scores: No/low improvement is < 25 percent (%) of maximum reduction from baseline. Mild improvement: maximum reduction from baseline on CDRS-R score ≥ 25% up to <50% and YMRS elevated mood score ≤ 2. Moderate improvement: maximum reduction from baseline on CDRS-R score ≥50% and <75% and YMRS elevated mood score ≤ 2. Major improvement: maximum reduction from baseline on CDRS-R score ≥75% and YMRS elevated mood score ≤ 2. CDRS-R measures presence/severity of depression in children. Scale is 17 items scored 1-to-5- or 1-to-7. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores < 20 absence of depression, scores 20 to 30 borderline depression, scores 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures severity of manic episodes. Four items rated 0 (symptoms not present) to 8 (symptom extremely severe). Remaining items rated 0 (symptoms not present) to 4 (symptom extremely severe). Score range: 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both CDRS-R and YMRS total scores with a baseline and at least 1 post-baseline measurement; LOCF.||percentage of participants|||Number
96436|NCT00844857|Secondary|Percentage of Participants With Response Up to Week 8|Response is defined as a CDRS-R total score greater than or equal to (≥)50% reduction from baseline and YMRS elevated mood score ≤2. CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. In general, <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had all of CDRS-R and YMRS total scores at baseline and at least 1 post-baseline measurement; LOCF||percentage of participants|||Number
96447|NCT00844844|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96479|NCT00844597|Secondary|Efficacy of Eteplirsen Over 12 Weeks of Dosing|Efficacy was defined as an estimated change in the percentage of dystrophin positive fibers (assessed by IHC) at Week 14 from Baseline after 12 weekly doses of eterplirsen. This outcome measure represents the number of patients to show an increase in the percentage of dystrophin-positive fibers.|Biopsies were taken at Baseline and Week 14|Per Protocol Population - Included all patients who received all 12 doses of study treatment.||participants|||Number
96437|NCT00844857|Secondary|Percentage of Participants With Remission Up to Week 8|Remission is defined as a CDRS-R total score less than or equal to (≤)28, and Young Mania Rating Scale (YMRS) total score ≤ 8 and Clinical Global Impressions-Bipolar Version (CGI-BP) total score ≤3. CDRS-R is a 17-item scale measuring presence/severity of depression in children and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, scores 40 to 60 indicate moderate depression. The YMRS is an 11-item scale measuring severity of manic episodes; 4 items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe) with remaining items rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). YMRS score ranges from 0 to 60. CGI-BP measures participant's overall severity of bipolar symptoms. Scores range: 1 (normal, not at all ill ) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both the CDRS-R, YMRS and CGI-BP total scores at baseline and at least 1 post-baseline measurement; Last Observation Carried Forward (LOCF)||percentage of participants|||Number
96438|NCT00844857|Primary|Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8|CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (*) visit interaction.|Baseline, Week 8|Population analyzed was the Modified Intention-to-Treat (M-ITT) Population: defined as all randomized participants who took at least 1 dose of study drug and excluding participants from 2 Good Clinical Practice (GCP) noncompliant sites and who had a baseline and at least 1 post-baseline CDRS-R measurement.||units on a scale||Standard Error|Least Squares Mean
96439|NCT00844844|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mil||Standard Deviation|Mean
96440|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
96441|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
96442|NCT00844844|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96443|NCT00844844|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96444|NCT00844844|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
96445|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
96446|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥ 25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
96478|NCT00844597|Primary|Treatment Emergent Adverse Events|Number of Patients with Treatment Emergent Adverse Events|from Baseline to Follow up (27 weeks)|Safety Population||participants|||Number
96448|NCT00844844|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96449|NCT00844844|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study visit for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
96450|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase|"ASAS-20 response was defined as ≥20% improvement in response according to following criteria:~• An improvement of ≥20% from baseline and an absolute improvement from~baseline of ≥10 mm in at least 3 of the following 4 domains (patient global assessment, pain, function,and inflammation)~• Absence of deterioration from baseline (≥20% and an absolute change of~≥10 mm) in the potential remaining domain."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Percentage of Participants|||Number
96451|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS-40 response was defined as ASAS achieving ≥40% improvement in 3 of the 4 domains (patient global assessment, total back pain, function, and inflammation), with an absolute improvement of ≥20 mm and no deterioration in the remaining domain.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Percentage of Participants|||Number
96452|NCT00844805|Secondary|Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase|"The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) employs a VAS of 0mm (best) to 100mm (worst). Disease flare was defined as reaching a BASDAI of ≥30 mm during two consecutive visits after Week 28 until Week 52.~ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria was defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation)."|Week 52|The Intent-to-Treat Population consisted of all subjects who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96453|NCT00844805|Secondary|Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized to treatment, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Weeks||Full Range|Median
96454|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active spinal inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96455|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52|EaEach sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96456|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants that were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96521|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96457|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96458|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions at the sacroiliac joints was defined as a Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96459|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96460|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 52|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.||Units on a Scale||Inter-Quartile Range|Median
96461|NCT00844805|Secondary|Change From Baseline of Berlin MRI Spine Overall Score at Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 52|The number of participants represents those with a Week 28 values and those with a Week 52 value.||Units on a Scale||Inter-Quartile Range|Median
96462|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.||Units on a Scale||Inter-Quartile Range|Median
96463|NCT00844805|Secondary|Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28|MRI scans (T1 for chronic changes and short tau inversion recovery [STIR] for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.||Units on a Scale||Inter-Quartile Range|Median
96464|NCT00844805|Secondary|Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Percentage of Participants|||Number
96465|NCT00844805|Secondary|Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96466|NCT00844805|Primary|Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28|ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.||Participants|||Number
96467|NCT00844753|Primary|Percentage of Participants Who Were Autism Spectrum Disorder Respondents|"Respondents were defined as having ≥30% decrease on the HSQ and CGI-I≤2). The 25-item HSQ was adapted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate behavioral noncompliance in children with autism spectrum disorder (ASD). The Home Situations Questionnaire – Pervasive Developmental Disorder (HSQ) is a 25-item parent rating scale assessing noncompliance. Parents are asked to indicate whether each item is a problem and, if so, its severity from 1 (mild) to 9 (severe). The School Situations Questionnaire (SSQ) is a 9-item teacher rating scale that assesses noncompliance. The SSQ is a companion instrument to the HSQ and uses the same rating scale.~The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill),"|week 10|||percentage of participants|||Number
96468|NCT00844753|Primary|Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents|Respondents were defined as having ≥30% decrease on the SNAP and CGI-I<=2). The Swanson, Nolan, and Pelham (SNAP)–IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), with a rating of ≥4 required for inclusion. The Improvement score ranged from 1 (very much improved) through 4 (no change) to 7 (very much worse). The CGI was completed by a blinded rater based on parent/child interview and review of completed parent and school behavior problem questionnaires at each study visit.|week 10|||percentage of participants|||Number
96469|NCT00844714|Primary|Flow-mediated Vasodilation (FMD)|endothelial function as assessed by flow-mediated vasodilation of the brachial artery|12 weeks, 24 weeks|||percentage change in diameter||Inter-Quartile Range|Median
96470|NCT00844649|Other Pre-specified|Number of Participants With Dose Delays/Doses Not Given|The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.|Up to 666 days|Treated Population||number of dose delays|||Number
96471|NCT00844649|Other Pre-specified|Number of Participants With Dose Interruptions|The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Safety population, includes participants who received at least one study treatment||participants|||Number
96472|NCT00844649|Other Pre-specified|Number of Participants With Dose Reductions|The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Treated Population||participants|||Number
96473|NCT00844649|Other Pre-specified|Participants With Treatment Emergent Adverse Events (AE)|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days|Treated patient population||participants|||Number
96474|NCT00844649|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)|Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months|Intent to Treat population (ITT population) consisted of all randomized participants.||percentage of participants||95% Confidence Interval|Number
96475|NCT00844649|Secondary|Progression-free Survival (PFS) by Independent Radiological Review (IRR)|Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.|Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.||months||95% Confidence Interval|Median
96476|NCT00844649|Primary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.|From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.||months||95% Confidence Interval|Median
96477|NCT00844597|Post-Hoc|Adverse Events >15%|Adverse events that occurred in >15% of overall patient population across dose level arms.|27 Weeks|Safety Population||Events|||Number
96480|NCT00844597|Secondary|Pharmacokinetics - Mean Peak Plasma Concentration of AVI-4658 After Administration|Standard Pharmacokinetic parameters estimated using non-compartmental modeling of plasma concentration data.|Samples were taken: 30 minutes pre dose; and at 5 (±1), 15 (±2), 30 (±5), 60 (±5), and 90 (±5) minutes; and 2, 4, 6, 8, 12, and 24 hours (all ± 15 minutes) post dose at Weeks 1, 6, and 12|PK Evaluable Population: Included all patients who provided at least 1 PK sample. The reportable PK population included those patients with at least Cmax, Tmax, and AUC0-24 computed from 1 or more of the 3 sampling days (1st, 6th, 12th dose [Weeks 1, 6, and 12]).||ng/mL||Standard Deviation|Mean
96481|NCT00844597|Primary|Safety and Tolerability|Number of subjects with 1 or more Treatment Emergent Adverse Event that are possibly related to the investigational drug|Baseline to 6 months|Safety Population - Any patient who received at least one dose of the study drug.||participants|||Number
96482|NCT00844558|Secondary|Change in Chair Stand Time|Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.|0,3,6,and 12 months|||seconds||95% Confidence Interval|Mean
96483|NCT00844558|Secondary|Change in Stair Climb Time, Secs|Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm)|0,3,6, and 12 months|||seconds||95% Confidence Interval|Mean
96484|NCT00844558|Secondary|Change in Long Distance Corridor Walk (LDCW) Time, Secs|The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale.|0,3,6 and 12 months|||seconds||95% Confidence Interval|Mean
96485|NCT00844558|Secondary|Change in KOOS Symptoms|"This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.~Scored from 0 to 100 with 100 indicating no symptoms."|0,3,6 and 12 months|||units on a scale||95% Confidence Interval|Mean
96486|NCT00844558|Secondary|Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain|"This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.~Scored from 0 to 100 with 100 indicating no pain."|0,3,6 and 12 months|||units on a scale||95% Confidence Interval|Mean
96487|NCT00844558|Primary|Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument|"This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities.~Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance)."|0,3,6, and 12 months|||units on a scale||95% Confidence Interval|Mean
96488|NCT00844545|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data||micrograms/mil||Standard Deviation|Mean
96489|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
96490|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
96491|NCT00844545|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96492|NCT00844545|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96493|NCT00844545|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
96494|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||# events/patient/day||Standard Deviation|Mean
96495|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
96496|NCT00844545|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96497|NCT00844545|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96498|NCT00844545|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
96499|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
96500|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
96501|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
96502|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
96503|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
96504|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
96522|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|18 months|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96505|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||scores on a scale||Standard Deviation|Mean
96506|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||score on a scale||Standard Deviation|Mean
96507|NCT00844532|Secondary|Stent Thrombosis|Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants|95% Confidence Interval|Number
96508|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96509|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96510|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|18 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96511|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96512|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
96513|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
96514|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
96515|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.||percentage of limbs|Participants||Number
96516|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96517|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96518|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96519|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
96520|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|3 years|ITT population. This analysis represents those subjects who were event free at this time point.||percentage of participants|||Number
102264|NCT00795951|Primary|Diagnostic Performance: Mercapto Mix|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
96527|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
96528|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
96529|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
96530|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of limbs|Participants||Number
96531|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population.This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
96532|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
96533|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
96534|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.||percentage of limbs|Participants||Number
96535|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96536|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96537|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96538|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96539|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|3 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96540|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|2 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96541|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96542|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|1 month and 9 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.||percentage of target vessels|Participants||Number
96543|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96544|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96545|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96546|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96547|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96548|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96549|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96854|NCT00843024|Other Pre-specified|Number of Participants of the Indicated Race Categorized by Age Group|The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Participants|||Number
96550|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.||percentage of target lesions|Participants||Number
96551|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96552|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96553|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96554|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96555|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96556|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96557|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96558|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96559|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Percentage of Limbs|Participants||Number
96560|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
96561|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
96562|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
96563|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||scores on a scale||Standard Deviation|Mean
96564|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|Pre-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.||score on a scale||Standard Deviation|Mean
96565|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96566|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96567|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96568|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96569|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Post-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96570|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96571|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96572|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96573|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|Per target limb analysis.ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96574|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96575|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.||Ratio|Participants|Standard Deviation|Mean
96576|NCT00844532|Secondary|Procedure Success|Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population||percentage of participants||95% Confidence Interval|Number
96577|NCT00844532|Secondary|Technical Success|Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of < 30% by QA or as reported by the investigator, if QA is not available.|acute: from beginning of index procedure to end of index procedure.|ITT population||percentage of target lesions|Participants|95% Confidence Interval|Number
96578|NCT00844532|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|acute: from beginning of index procedure to end of index procedure.|Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.||percentage of devices|Participants|95% Confidence Interval|Number
96579|NCT00844532|Primary|Major Adverse Event (MAE) Rate|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.||percentage of participants||95% Confidence Interval|Number
96580|NCT00844519|Primary|Percent Change in FMD|endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery|Baseline, 24 weeks|||percent change in FMD||Standard Deviation|Mean
96581|NCT00844428|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.||micrograms/mil||Standard Deviation|Mean
96582|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96583|NCT00844428|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
96584|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
96585|NCT00844428|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
96586|NCT00844428|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96587|NCT00844428|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96588|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96589|NCT00844428|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
96590|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
96591|NCT00844428|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
96592|NCT00844428|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96593|NCT00844428|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
96594|NCT00844415|Secondary|Occurences of Clinical Outcome|Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.|3 days|TS||Participants|||Number
96595|NCT00844415|Secondary|Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs|Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.|Baseline and 3 days|TS||Participants|||Number
96596|NCT00844415|Secondary|Ecarin Clotting Time (ECT)|Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
96597|NCT00844415|Secondary|aPTT Locally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
96598|NCT00844415|Secondary|Activated Partial Thromboplastin Time (aPTT) Centrally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
96599|NCT00844415|Primary|TT Locally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
96600|NCT00844415|Primary|Thrombin Time (TT) Centrally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data||seconds||Standard Deviation|Mean
96601|NCT00844415|Primary|Plasma Concentration of Total Dabigatran|Plasma concentration of total dabigatran measured at 72 hours after first dose|Day 3|TS with non-sparse data||ng/ml||Geometric Coefficient of Variation|Geometric Mean
96602|NCT00844415|Primary|Plasma Concentration of Free Dabigatran|Plasma concentration of free dabigatran measured at 72 hours after first dose|3 days|Treated Set. Descriptive statistics for the concentration measurement could only be calculated for the subgroups of patients receiving the same sequence of doses. Statistics were only reported for groups with at least 3 patients (non-sparse data).||ng/ml||Geometric Coefficient of Variation|Geometric Mean
96603|NCT00844415|Primary|Number of Patients With Adverse Events|Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered „on-treatment“ if occurring within 72 hours after last drug administration.|From Screening until 30 days after first drug administration (end of trial visit)|TS||Participants|||Number
96629|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96630|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 12|||Scores of a scale||Standard Deviation|Mean
96604|NCT00844415|Primary|Number of Patients With Bleeding Events (Major and Minor)|"Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:~Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds."|From Screening until 30 days after first drug administration (end of trial visit)|Treated set (TS). This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||Participants|||Number
96605|NCT00844376|Secondary|Plasma Elimination Half-life (t1/2)|Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.|5 days|||hr||Standard Deviation|Mean
96606|NCT00844376|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).|5 days|||hr||Full Range|Median
96607|NCT00844376|Secondary|Terminal Phase Rate Constant (Kel)|Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).|5 days|||1/hr||Full Range|Geometric Mean
96608|NCT00844376|Primary|Maximum Observed Plasma Concentration (Cmax)|Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).|5 days|||ng/mL||Full Range|Geometric Mean
96609|NCT00844376|Secondary|Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)|Geometric mean of AUClast = area under the plasma concentration-time curve from time zero (0) to the last measurable concentration of atorvastatin (test vs reference); measured as ng.hr/mL|5 days|||ng.hr/mL||Full Range|Geometric Mean
96610|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)|Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).|5 days|||ng.hr/mL||Full Range|Geometric Mean
96611|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)|Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus [vs] reference); measured in nanograms times hour per milliliter (ng.hr/mL).|5 days|||ng.h/mL||Full Range|Geometric Mean
96612|NCT00844298|Secondary|Overall Survival||2 years||||||
96613|NCT00844298|Secondary|Disease(Relapse)-Free Survival||2 years||||||
96614|NCT00844298|Primary|Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy|approximate time: at the recovery of cytopenia|1 month|||percentage of analyzable subjects|||Number
96615|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96616|NCT00844194|Secondary|Change of Pulse Rate From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
96617|NCT00844194|Secondary|Change of Diastolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.||mmHg||Standard Deviation|Mean
96618|NCT00844194|Secondary|Change of Systolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.||mmHg||Standard Deviation|Mean
96619|NCT00844194|Secondary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12.||percent||95% Confidence Interval|Least Squares Mean
96620|NCT00844194|Secondary|Change of Fasting Blood Glucose From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12.||mg/dL||95% Confidence Interval|Least Squares Mean
96621|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.||Participants|||Number
96622|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.||Participants|||Number
96623|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.||Participants|||Number
96624|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.||Participants|||Number
96625|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.||Participants|||Number
96626|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.||Participants|||Number
96627|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96628|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores of a scale||Standard Deviation|Mean
96631|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96632|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96633|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12|Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96634|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6|Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96635|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12|Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96636|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6|Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96637|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96638|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96639|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12|Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96640|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6|Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96641|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96642|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96643|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96785|NCT00843479|Primary|Glucose Infusion Rate|Whole-body insulin sensitivity, as estimated by the mean glucose infusion rate corrected for fat-free mass(FFM){mg*[kg(FFM)^-1]*min*10} at last 60 min of 180-min hyperglycemic clamp|within 1 month from screening visit|||mg*[kg(FFM)^-1]*min*10||Standard Deviation|Mean
96644|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96645|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96646|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96647|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96648|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96649|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96650|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96651|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96652|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96653|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96654|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96655|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96656|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96853|NCT00843024|Other Pre-specified|Mean Weight of Participants at Baseline Categorized by Age Group|The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Kilograms (kg)||Standard Deviation|Mean
96657|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96658|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96659|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96660|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96661|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96662|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96663|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96664|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96665|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96666|NCT00844194|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96667|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96668|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96669|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96670|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 12|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96671|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 6|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96672|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 2|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96673|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96674|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96675|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96676|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96677|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96678|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96679|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96680|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96681|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96682|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96683|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96684|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96685|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96686|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96687|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96688|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96689|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96690|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96691|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96692|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96693|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96694|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12|The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||scores on a scale||Standard Deviation|Mean
96695|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6|The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||scores on a scale||Standard Deviation|Mean
96696|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2|The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||scores on a scale||Standard Deviation|Mean
96697|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 12|The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96698|NCT00844194|Secondary|Change in Pain (BPI) From Baseline to Week 6|The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96699|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 2|The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96700|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Participants|||Number
96701|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 6||Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Participants|||Number
96702|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 2||Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Participants|||Number
102265|NCT00795951|Primary|Diagnostic Performance: Formaldehyde|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
96703|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96704|NCT00844194|Secondary|Change in Average Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96705|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96706|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96707|NCT00844194|Secondary|Change in Least Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96708|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96709|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96710|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96711|NCT00844194|Secondary|Change in BPI Worst Pain During Treatment From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96712|NCT00844194|Secondary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96713|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5||Scores on a scale||Standard Deviation|Mean
96714|NCT00844090|Primary|Change in HbA1c Over Baseline|measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months|6 months from baseline|per protocol||percentage of HbA1c||Standard Deviation|Median
96715|NCT00844051|Secondary|Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year|||days per 100 school days||Standard Deviation|Mean
96716|NCT00844051|Primary|Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year|||flu+ per 1000 children|||Number
96717|NCT00843986|Secondary|Total Urine Output at Hours 6, 12, 24, 48 and 72|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96718|NCT00843986|Secondary|Total Loop Diuretic Use Through 48 Hours|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96719|NCT00843986|Secondary|Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge)|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96720|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity).~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96721|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~Changes in Dyspnea were assessed using the following 7-point Likert scale:~1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96722|NCT00843986|Secondary|Termination of Study Drug Due to an Adverse Event or Intolerability|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48.5 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96723|NCT00843986|Secondary|Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Day 9|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96724|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance|"Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation.~MDRD = Modification of Diet in Renal Disease~The MDRD equation is a standard calculation for estimated glomerular filtration rate.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 24 Hours, 48 Hours and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96725|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96726|NCT00843986|Primary|Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|24 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96727|NCT00843986|Primary|Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)|"MDRD = Modification of Diet in Renal Disease~The MDRD equation is a standard calculation for estimated glomerular filtration rate.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.|||||
96728|NCT00843843|Secondary|Psychomotor Vigilance|Fastest 10% reaction time (msec)|after short or long nights|Means||msec||Standard Deviation|Mean
96729|NCT00843843|Primary|Dim Light Melatonin Onset (Hours)|Gold standard marker of circadian timing|12 days from baseline to final dim light melatonin onset|||hours||Standard Deviation|Mean
96730|NCT00843830|Secondary|Number of Patients That Respond to Treatment|To evaluate the anti-tumor response as determined by RECIST criteria|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.|||||
96731|NCT00843830|Primary|The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.|The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.|||||
96732|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 12|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96733|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 10|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96734|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 8|Of the 130 subjects in the Full Analysis Set, 34 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96735|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 6|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96736|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 4|Of the 130 subjects in the Full Analysis Set, 35 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96737|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 2|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96738|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 0|Of the 130 subjects in the Full Analysis Set, 31 subjects are included in the analysis of this outcome measure, based upon the number of subjects receiving hospital nurse injection at this visit, with an available assessment score at the visit.||units on a scale||Standard Deviation|Mean
96739|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 12|Of the 130 subjects in the Full Analysis Set, 74 or 75 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96740|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 10|Of the 130 subjects in the Full Analysis Set, 72, 73 or 74 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96741|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 8|Of the 130 subjects in the Full Analysis Set, 78, 79 or 80 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96742|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 6|Of the 130 subjects in the Full Analysis Set, 66, 67 or 68 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96743|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 4|Of the 130 subjects in the Full Analysis Set, 82 or 83 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96744|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 2|Of the 130 subjects in the Full Analysis Set, 80 or 81subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96745|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 65 or 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96746|NCT00843778|Secondary|Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The three domains of the PRE SIAQ are feelings about injections, self-confidence, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting completed this pre-self-injection questionnaire. The PRE-SIAQ is taken before the subject's first injection.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.||units on a scale||Standard Deviation|Mean
96747|NCT00843778|Secondary|Percentage of Subjects Willing to Self-inject at Week 0|The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set.|Week 0 of this study (C87080 [NCT00843778])|Full Analysis Set||percentage of participants|||Number
96748|NCT00843778|Secondary|Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study|Antibody positive is defined as Anti-CZP antibody levels > 2.4 units/mL at any visit.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Safety Set||percentage of participants|||Number
96749|NCT00843778|Secondary|Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. Values below the limit of quantification of 0.41 μg/mL will be set to half the limit of quantification for the summaries (0.205 μg/mL).|Week 24|Of the 130 subjects in the Safety Set, 89 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||μg/mL||95% Confidence Interval|Geometric Mean
96750|NCT00843778|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96751|NCT00843778|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|"Change from Baseline in Fatigue Assessment Scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement."|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 117 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96752|NCT00843778|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 102 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Mean
96753|NCT00843778|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||units on a scale||Standard Deviation|Median
96754|NCT00843778|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
96755|NCT00843778|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
96756|NCT00843778|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
96757|NCT00843778|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. <= 3.3 (Remission), >3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 120 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
96758|NCT00843778|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. A lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 122 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
96759|NCT00843778|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 114 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.||percentage of participants|||Number
96760|NCT00843778|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.|From Entry Visit up to approximately 144 weeks|Safety Set||percentage of participants|||Number
96761|NCT00843778|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.|From Entry Visit up to approximately 144 weeks|Safety Set||percentage of participants|||Number
96762|NCT00843713|Primary|Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)|Measurements in the change of brachial artery diameter from pre and post treatment.|24 weeks|||millimeters||Inter-Quartile Range|Median
96763|NCT00843635|Secondary|Number of Participants Experiencing Adverse Events|Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events|From Day 1 to Day 20|||participants|||Number
96764|NCT00843635|Secondary|Optimal Dosing Schedule for Tadalafil||Baseline, End of Treatment at Time of Surgery.|Optimal dosing schedule of Tadalafil not determined due to no proven superiority of one dosing arm over the other.|||||
96765|NCT00843635|Primary|Ratio of Tumor-specific T-cell Concentration in the Blood|Ratio of the number of tumor specific T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at Time of Surgery|Data for 31 patients were analyzed.||ratio from baseline||Inter-Quartile Range|Median
96766|NCT00843635|Primary|Ratio of T-reg Cell Concentration in the Blood|Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..|Baseline, End of Treatment at Time of Surgery|||ratio from baseline||Inter-Quartile Range|Median
96767|NCT00843635|Primary|Ratio of MDSC Concentration in the Blood|Ratio of the number of Myeloid Derived Suppressor Cells (MDSC) in the Blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at time of Surgery|||ratio from baseline||Inter-Quartile Range|Median
96768|NCT00843622|Secondary|Continuous Smoking Cessation|Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits|6-16 weeks||||||
96769|NCT00843622|Secondary|Point Prevalence Smoking Cessation|7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less|6, 16, 28 weeks||||||
96770|NCT00843622|Secondary|Biomarkers||Baseline, week 6, 16, and 28||||||
96771|NCT00843622|Secondary|Fagerström Test for Nicotine Dependence||Baseline, week 16 and 28||||||
96772|NCT00843622|Secondary|Minnesota Nicotine Withdrawal Scale||Baseline, week 6, 10, 16 and 28||||||
96773|NCT00843622|Primary|Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm||Week 6-28|||participants|||Number
96774|NCT00843492|Secondary|Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|All episodes of bleeding, except minor bruising, skin hematomas not greater than 5 centimeters in diameter, self-limited epistaxis (bleeding through the nose), and self-limited gingival (gum) bleeding, were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population||participants|||Number
96775|NCT00843492|Secondary|Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population||participants|||Number
96776|NCT00843492|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Clinically relevant non-major bleeding that does not qualify as major is defined as bleeding leading to treatment discontinuation, and/or epistaxis (bleeding through the nose) that lasts for more than 5 minutes or necessitates intervention (e.g., packing), spontaneous macroscopic haematuria (blood in urine), gastrointestinal haemorrhage, haemoptysis (coughing up blood), or subcutaneous haematoma (localized collection of blood) > 100 centimeters squared. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population||participants|||Number
96777|NCT00843492|Secondary|Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Major bleeding is defined as bleeding that results in a fatality, symptomatic bleeding in a critical area or organ, bleeding causing a fall in hemoglobin level of 20 grams/liter (1.24 millimoles/liter) or more compared with the pre-randomization hemoglobin level, or bleeding that leads to a transfusion of two or more units of whole blood or red blood cells. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population: all participants who received at least one dose of study treatment||participants|||Number
96778|NCT00843492|Secondary|Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact|The number of participants with VTE (defined as asymptomatic deep vein thrombosis [DVT: the formation of a blood clot in a deep vein] detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism [PE]) and death was assessed. An embolism is a clot in the blood that forms and blocks a blood vessel. A PE is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches.|Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days)|ITT Population||participants|||Number
96779|NCT00843492|Secondary|Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death|All components of the primary endpoint were considered separately: any VTE; symptomatic (providing no evidence of disease existence) DVT (the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography; symptomatic(providing evidence of disease existence) DVT; symptomatic PE (blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung of one of its branches); and death.|Day 1 to complete mobilization plus 2 days (average of 35.7 study days)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
96780|NCT00843492|Primary|Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization|VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).|Day 1 to complete mobilization plus 2 days (average of 35.9 study days)|Intent-to-Treat (ITT) Population: all randomized participants with a VTE status or experiencing death. Participants without evaluation of the primary endpoint in the timeframe requested by the protocol were considered as missing data and therefore not included in the primary efficacy analysis.||participants|||Number
96781|NCT00843479|Secondary|GLP-1 Area Under the Curve (AUC)|Area under the curve of glucagon-like peptide (GLP-1) concentrations (measured by ELISA kit) from time 0 to 180 min during a standard meal tolerance test, calculated by the trapezoidal rule.|1 month from screening visit|||pg/ml/min||Standard Deviation|Mean
96782|NCT00843479|Secondary|Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration|measured in fasting serum sample by ELISA kit|within 1 month from screening visit|||pg/ml||Standard Deviation|Mean
96783|NCT00843479|Primary|Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.|Distinctive beta-cell function as measured by the disposition index - based on the acute insulin response from the arginine stimulation test versus glucose infusion rate adjusted by free fat mass from hyperglycemic clamp - in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects.|within 1 month from screening visit|||(μmol∙kg-1.min-1)||Standard Error|Mean
96784|NCT00843479|Primary|Adaptive Beta-cell Insulin Production. The Product of Meal Tolerance Test-derived Insulinogenic Index (IGI) for Clamp-derived Insulin Sensitivity Index (ISI) in Normoglycemic Subjects After 65 Years Old in Comparison With Middle-age Normoglycemic Subjects|Beta-cell function was determinated as the beta-cell secretion measured by meal tolerance test adjusted by insulin sensitivity assessed by the hyperglycemic clamp test:Insulinogenic Index/Insulin Sensitivity Index adjusted by free fat mass|within 1 month from screening visit|||(μmol∙kg-1min-1)||Standard Deviation|Mean
96786|NCT00843479|Primary|Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index|Insulin sensitivity index calculated as HOMA-IR = (Glucose * Insulin) / 22.5, where glucose is mmol/L and insulin is mili-units (mU)/L. Higher values indicate lower insulin sensitivity.|within 1 month from screening visit|minimum number required to find a significant difference between groups considering the intra-subject variation||units on a scale||Standard Deviation|Mean
96787|NCT00843349|Primary|Percentage Changes in Parathyroid Hormone (PTH) Levels|Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.||percentage of change from baseline||Standard Deviation|Mean
96788|NCT00843349|Primary|Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels|Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.||percentage of change from baseline||Standard Deviation|Mean
96789|NCT00843310|Secondary|Progression Free Survival||every 28 days during therapy and every month after therapy for 2 years|The study was terminated due to slow accrual and PI leaving the institution (8 participants vs. 37 target accrual). No data were analyzed.|||||
96790|NCT00843310|Secondary|Time to Progression|Progression of disease is evaluated using the International Uniform Response Criteria by the International Myeloma Working Group.|every 28 days during therapy and every month after therapy for 2 years|The study was terminated due to slow accrual and PI leaving the institution (8 participants vs. 37 target accrual). No data were analyzed.|||||
96791|NCT00843310|Secondary|Drug Toxicity Rates|Percentage of participantswho experienced an adverse event among the treated population.|during therapy and 30 days after|Please see the reports on AEs and SAEs in next section.|||||
96792|NCT00843310|Primary|Overall and Complete Response Rates|"Response rate is defined as the percentage of patients who achieved response out of the total enrolled patients. Response is evaluated using the International Uniform Response Criteria by the International Myeloma Working Group.~Overall response = stringent complete response+complete response+very good partial response+partial response;~Complete response = stringent complete response+complete response"|every 28 days during therapy and every month after therapy for 2 years|The study was terminated due to slow accrual and PI leaving the institution (8 participants vs. 37 target accrual). No data were analyzed.|||||
96793|NCT00843284|Secondary|Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)|"Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.||participants|||Number
96794|NCT00843284|Secondary|Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)|"Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. Three subjects were not included in the analysis due to incomplete case report forms.||participants|||Number
96795|NCT00843284|Primary|Pain Related Sleep Interference|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.||scores on a scale||Standard Deviation|Mean
96796|NCT00843284|Primary|Daily Average Pain Scores|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.||scores on scale||Standard Deviation|Mean
96797|NCT00843284|Secondary|Anxiety and Depression Symptoms|The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward method (LOCF) was used.||participants|||Number
96798|NCT00843180|Secondary|Days to Recovery Neutrophil Count|number of days to recovery neutrophil count >500 cells per microliter for 2 consecutive days (range, up to 100 days, censored at 100 days)|hospital stay|||number of days||95% Confidence Interval|Mean
96799|NCT00843180|Secondary|Days of Hospital Stay|days of hospital stay after bone marrow transplant (up to 100 days; participant observation was censored after 100 days)|days of hospital stay after bone marrow transplant|ITT||number of days||95% Confidence Interval|Mean
96800|NCT00843180|Secondary|Number of Vomiting Episodes|number of vomiting episodes as reported by nurses per occurence (no upper limit)|day -7 to +21 around transplant date|ITT||number of episodes||95% Confidence Interval|Mean
96801|NCT00843180|Primary|Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)|days of pain >3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)|7 days pre to 21 days post transplant = 28 days|ITT no imputations||days||95% Confidence Interval|Mean
96802|NCT00843167|Secondary|Treatment Compliance|For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant.|Baseline and end of study (up to 8 weeks)|||participants|||Number
102266|NCT00795951|Primary|Diagnostic Performance: p-Phenylenediamine|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
96803|NCT00843167|Primary|Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy|PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.|Baseline and End of Study (up to 8 weeks)|PBMCs available pre-/post-intervention.||pmol/min/mg protein||Standard Error|Mean
96804|NCT00843167|Primary|Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy|Ki-67 was measured through immunohistochemistry method. A modified H-score was recorded, which involved semi-quantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate staining, and 3 strong staining) and percentage of positive cells. The range of the H-score was 0-300. The maximum score indicates the strongest expression, the minimum score indicates no expression of positive tumor area.|Baseline and end of study (up to 8 weeks)|Maximum two observations (pre- and post- treatments) were expected per participant. Linear mixed effect models were used to calculate adjusted least square means (LSMEANS) and 95% confidence intervals,& to test the statistical significance of the difference between pre- and post- treatments within each group, as well as between treatment groups.||Log 2 (H-score)||95% Confidence Interval|Least Squares Mean
96805|NCT00843167|Primary|Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy|Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.|Baseline and end of study (up to 8 weeks)|||µM/mM creatinine||Standard Error|Mean
96806|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF"|baseline, Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96807|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96808|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96809|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96810|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF"|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96811|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96812|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF."|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96813|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12"|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96814|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT) LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96815|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12."|baseline, 12 Weeks|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96816|NCT00843115|Secondary|LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks LOCF|Intent to Treat (ITT)LOCF: (n=318; number of subjects responding).||score on scale||Standard Deviation|Mean
96817|NCT00843115|Secondary|Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT): (n=286; number of subjects responding).||score on scale||Standard Deviation|Mean
96818|NCT00843115|Secondary|LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=321; number of subjects responding)||score on scale||Standard Deviation|Mean
96819|NCT00843115|Secondary|Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score|baseline, 12 Weeks|Intent to Treat (ITT) (n=290; number of subjects responding)||score on scale||Standard Deviation|Mean
96820|NCT00843115|Secondary|Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=231; number of patients responding)||Pearson Product Correlation Coefficient|||Number
96821|NCT00843115|Secondary|Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.|baseline, 12 Weeks|Intent to Treat (ITT). (n=207 number of subjects responding)||Pearson Product Correlation Coefficient|||Number
96822|NCT00843115|Secondary|LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Week LOCF|Intent to Treat (ITT)LOCF: (n=231; number of subjects responding)||score on scale||Standard Deviation|Mean
96823|NCT00843115|Secondary|Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT). (n= 207; number of subjects who responded)||score on scale||Standard Deviation|Mean
96824|NCT00843115|Secondary|Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=231; number of subjects responding).||Pearson Product Correlation Coefficient|||Number
96825|NCT00843115|Secondary|Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.|baseline, 12 Weeks|Intent to Treat (ITT); n=207 (number of subjects who responded)||Pearson Product Correlation Coefficient|||Number
96826|NCT00843115|Secondary|Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=318; number of subjects responding)||score on scale||Standard Deviation|Mean
96827|NCT00843115|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.|baseline, Week 12|Intent to Treat (ITT): (n=288; number of subjects responding)||score on scale||Standard Deviation|Mean
96828|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96829|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96830|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96831|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96832|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96833|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96834|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96835|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96836|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96837|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96838|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96839|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96840|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96841|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96842|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96843|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96844|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96845|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||participants|||Number
96846|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis||Participants|||Number
96847|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT) : All subjects who did not have a response for post baseline assessment were not included in analysis.||Participants|||Number
96848|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis.||participants|||Number
96849|NCT00843050|Secondary|Time to Progression|It is defined as the time from day 1 of the study drug administration until the first date of progressive disease.|End of study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.||years||Standard Deviation|Mean
96850|NCT00843050|Secondary|Duration of Response|It is defined as the time from when the measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively or clinically documented.|End of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.||proportion of participants||Inter-Quartile Range|Median
96851|NCT00843050|Primary|Best Overall Objective Response Rate|The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.|End of every 2 cycles and end of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.||proportion of participants||Standard Deviation|Mean
96852|NCT00843024|Other Pre-specified|Mean Body Mass Index of Participants at Baseline Categorized by Age Group|The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).|Baseline|ITT Population||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
96855|NCT00843024|Other Pre-specified|Number of Female and Male Participants Categorized by Age Group|The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Participants|||Number
96856|NCT00843024|Other Pre-specified|Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline|The number of participants receiving double-blind treatment were reported according to age.|Baseline|ITT Population||Participants|||Number
96857|NCT00843024|Other Pre-specified|Mean Age of Participants at Baseline Categorized by Age Group|The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population||Years||Standard Deviation|Mean
96858|NCT00843024|Secondary|Number of Participants Nausea-free at 2 Hours Post-dose|The number of participants who did not have nausea at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96859|NCT00843024|Secondary|Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.|Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96860|NCT00843024|Secondary|Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96861|NCT00843024|Secondary|Number of Participants Sustained Nausea-free From 2-24 Hours|Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96862|NCT00843024|Secondary|Number of Participants Sustained Phonophobia-free From 2-24 Hours|Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96863|NCT00843024|Secondary|Number of Participants Sustained Photophobia-free From 2-24 Hours|Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96864|NCT00843024|Secondary|Number of Participants Pain-free at 1 Hour Post-dose|Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.|1 hour after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96865|NCT00843024|Secondary|Number of Participants Phonophobia-free at 2 Hours Post-dose|The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96866|NCT00843024|Secondary|Number of Participants Photophobia-free at 2 Hours Post-dose|The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96880|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this BTP medication relieve your pain quickly so you can get back to sleep?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96867|NCT00843024|Secondary|Number of Participants Sustained Pain-free From 2-24 Hours|Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.||participants|||Number
96868|NCT00843024|Primary|Number of Participants Who Were Pain Free at 2 Hours Post-dose|Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population: participants who took a dose of double-blind randomized treatment and provided some assessment of their migraine pain or associated symptoms. Participants were not included in this analysis if their baseline pain was not moderate or severe, or if they had no post-baseline evaluation of pain up to the time point analyzed.||participants|||Number
96869|NCT00842985|Primary|CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing|"CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component.~This study used two subscales of the RVIP.~RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good.~RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present.~The range is from -1 to +1 ; bad to good~The numbers represent probabilities as units on a scale."|Once for each test session (4 total).|Subjects who completed all four treatment sessions. Three of these 15 subjects were not analyzed due to validity concerns of the cognitive data for at least one of the four testing sessions.||units on a scale||Standard Deviation|Mean
96870|NCT00842946|Primary|Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID))|"The SCID (First, Spitzer, Gibbon, & Williams, 1996) is an extensively utilized structured diagnostic interview based on DSM-IV criteria. Estimates of interrater reliability range from moderate to high for most Axis I disorders (e.g., Williams et al., 1992; Zanarini~& Frankenburg, 2001)."|6-weeks post-treatment|||participants|||Number
96871|NCT00842829|Secondary|Participants With Adverse Events (AE) Summarized by Treatment Period|Participants with treatment-emergent adverse events are summarized by each treatment period. Relation to study drug was assessed by the investigator. The 'Any AE' category below includes serious adverse events.|Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period)|Safety analysis set||participants|||Number
96872|NCT00842829|Secondary|Participant's Global Impression of Change at the End of the Treatment Period|Global impression of change was assessed using the question 'Since the start of the study, my overall status is?'. The answer was based on a 7-point scale (1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96873|NCT00842829|Secondary|Participant's Global Assessment of Ease of Use at the End of the Treatment Period|Ease of use was assessed using the question ‘Did you find this treatment easy/convenient to use for treatment of your breakthrough pain episodes?’. The answer was based on a 4-point numerical scale (0=Poor, 1=Fair, 2=Easy, 3=Very Easy). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96874|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you understand the instructions?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96875|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you feel safe taking this medication?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96876|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you find this medication comfortable to take in public?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96877|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Is this medication easy to take?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96878|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication provide adequate relief?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96879|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication work fast?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
102267|NCT00795951|Primary|Diagnostic Performance: Mercaptobenzothiazole|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
96881|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Satisfied with the BTP Treatment?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response||participants|||Number
96882|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score|Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. The Global Score is the sum of the subscales (total scale is 0-70). A negative change from baseline represents an improvement.|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96883|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Enjoyment of Life|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses enjoyment of life."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96884|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses sleep."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96885|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Relations With Other People|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses relations with other people."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96886|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses normal work."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96887|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses walking ability."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96888|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses mood."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96889|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses general activity."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses||units on a scale||Standard Deviation|Mean
96890|NCT00842829|Secondary|Participant Assessment of Medication Performance During the Treatment Period|Participants assessed the performance of FBT at 30 minutes and 60 minutes after dosing each episode during the treatment period. For each episode, the participant answered the question ‘How well did your study medication perform in controlling the breakthrough pain episode?’ on a 5-point Likert-type scale (poor=0, fair=1, good=2, very good=3, and excellent=4).|approximately Day 8-15|Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose.||BTP episodes|Participants||Number
96891|NCT00842829|Secondary|Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period|The number of breakthrough pain (BTP) episodes in which the participant did not obtain effective pain relief from study medication and took a rescue medication.|Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period)|Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period.||BTP episodes|Participants||Number
96997|NCT00841659|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
96892|NCT00842829|Secondary|Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period|Number of participants for which an effective dose of FBT was reached as judged by each participant. The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.||participants|||Number
96893|NCT00842829|Secondary|Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes|Overall episode data analyzed all values of time to meaningful pain relief taken over all BTP episodes during the treatment period. If meaningful pain relief was not achieved within 60 minutes of FBT intake, or if rescue medication was taken, the event was censored. Meaningful pain relief was left to the judgment of participants, who used a stopwatch and recorded the time from treatment until pain relief in a patient diary.|approximately Day 8-15|Safety analysis set consisting of participants who received at least one dose of study drug during the Treatment Period, and who recorded the time to pain relief in the patient diary.||minutes|Participants|Inter-Quartile Range|Median
96894|NCT00842829|Primary|Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period|The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.||percentage of treated participants|||Number
96895|NCT00842751|Primary|Serum Estradiol Concentration|Area under the curve of serum estradiol|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.||ng*hr/dL||Inter-Quartile Range|Geometric Mean
96896|NCT00842751|Primary|Serum Dihydrotestosterone Concentration|Area under the curve of serum dihydrotestosterone|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.||ng*hr/dL||Inter-Quartile Range|Geometric Mean
96897|NCT00842751|Primary|Maximum Testosterone Concentration|Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.|0,1,2,4,8,and 12-hour post dose|All participant received all treatments and is, therefore, included in the analysis population for all groups.||ng*hr/dL||Inter-Quartile Range|Geometric Mean
96898|NCT00842712|Secondary|Randomized Part: Time to Treatment Failure|Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC).|Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
96899|NCT00842712|Secondary|Randomized Part: Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
96900|NCT00842712|Secondary|Randomized Part: Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
96901|NCT00842712|Secondary|Randomized Part: Progression Free Survival (PFS) Time - Investigator Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
96902|NCT00842712|Primary|Randomized Part: Progression Free Survival (PFS) Time - Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
97065|NCT00840281|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|||ng*h/mL||Standard Deviation|Mean
96903|NCT00842712|Primary|Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)||Up to Week 3|DLT population included all participants who completed first 3 weeks of treatment (first chemotherapy cycle) or who discontinued treatment due to any DLT during the first 3 weeks of treatment in the safety-run-in part.||participants|||Number
96904|NCT00842543|Primary|Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys|Value at 6 months minus value at baseline. Beta-carotene is a component of the body’s natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline and 6 months|||Percent Change||Standard Error|Least Squares Mean
96905|NCT00842543|Primary|Beta-carotene Levels Between Overweight and Lean Boys at Baseline|Value at baseline. Beta-carotene is a component of the body’s natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline|||mM/L||Inter-Quartile Range|Median
96906|NCT00842361|Secondary|Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6.|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
96907|NCT00842361|Secondary|Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||mmHg||Standard Deviation|Mean
96908|NCT00842361|Secondary|Electrocardiogram (ECG) Worsening|The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||participants|||Number
96909|NCT00842361|Secondary|Change in Body Weight|Change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).||kg||Standard Deviation|Mean
96910|NCT00842361|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
96911|NCT00842361|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
96912|NCT00842361|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
96913|NCT00842348|Secondary|Progression Free Survival (PFS): Kaplan-Meier Estimate|"The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.~Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method."|Throughout the study (every 24 weeks and at completion/withdrawal visit)|Intention-to-treat (ITT) population: all patients randomised in the original protocol Study 726 (regardless of whether they continued into the extension Study 729). The ITT population was analysed using patients as randomised in Study 726.||weeks||95% Confidence Interval|Median
96914|NCT00842348|Primary|Adverse Events|"Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.~An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:~It was not present prior to receiving the first dose of study treatment in Study 729; or,~It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.~Adverse event data are presented in the AE section."|Throughout the study until the completion/early discontinuation visit.|Safety population: all patients who received at least one dose of lanreotide Autogel in Study 729.||participants with any TEAEs|||Number
96915|NCT00842335|Secondary|Days to Progression|Progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions|Up to 112 days (four 28-day cycles) or longer if the patient is benefiting from treatment|The efficacy analyses were performed using all patients, who had at least one post-treatment evaluation for tumor assessment (N=17). The overall response was based on the number of cycles of treatment before the participant experienced progressive disease.||days||Full Range|Median
96916|NCT00842335|Secondary|Overall Clinical Response by Cycle|"Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.~Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions"|Up to 112 days ( four 28-day cycles)|All 18 participants were analyzed.||participants|||Number
96917|NCT00842335|Secondary|Number of Participants Reaching Maximum Tolerated Dose|Number of participants withdrawn from study due to adverse events|Up to 112 days (up to four 28-day cycles) or longer if the patient is benefiting from treatment|Only one subject withdrew due to an adverse event.||participants|||Number
96918|NCT00842335|Primary|Maximum Tolerated Dose (MTD) of JI-101|"The primary objective of this study was to determine the maximum tolerated dose (MTD) of JI-101 when administered orally in patients with advanced solid tumors.~The MTD was established based on safety data from Cycle 1. Patients who completed 21 days of treatment in Cycle 1 were considered to have completed the study for the determination of MTD.~Patients were eligible to continue treatment with JI-101 until they experienced disease progression or unacceptable treatment-related toxicity. Unacceptable treatment-related toxicity was defined as a clinically significant AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and that was attributed to JI 101."|28 days (1 cycle)|"Full Analysis Population (FAS) or Modified Intent-to-Treat (mITT) Population: All patients enrolled into the study who received JI-101 and completed at least 21 days of dosing in Cycle 1 comprised the FAS.~Safety Population: Included all patients who received at least one dose of study drug. This population was used for all safety analyses."||mg|||Number
96919|NCT00842244|Secondary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was a>=20% increase in sum of the longest dimensions of target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.||months||95% Confidence Interval|Median
96920|NCT00842244|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR = disappearance of all target lesions. PR = at least 30% decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Analysis set included a subset of efficacy analysis set who had confirmed objective tumor response.||months||95% Confidence Interval|Median
96921|NCT00842244|Secondary|Percentage of Participants With Objective Response (OR)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent (%) decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.||percentage of participants||95% Confidence Interval|Number
96922|NCT00842244|Secondary|Drug Metabolizing Enzyme Genotyping|Genetic variants of uridine diphosphate (UDP)- glucuronosyl transferase 1A1 (UGT1A1) gene which were assessed for genotyping included UGT1A1*60, UGT1A1-3156, UGT1A1 Promoter thymine adenine (TA) repeat (UGT1A1*28, UGT1A1*36, UGT1A1*37), UGT1A1*6 and UGT1A1*27.|Day 1 of Cycle 1|Results are not reported because data was reported in individual participant listing but not statistically summarized for the analysis.|||||
96923|NCT00842244|Secondary|Volume of Distribution (Vz) for Cisplatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter||95% Confidence Interval|Geometric Mean
96924|NCT00842244|Secondary|Apparent Volume of Distribution (Vz/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Vz/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because Vz/F could not be accurately estimated.||Liter||95% Confidence Interval|Geometric Mean
96925|NCT00842244|Secondary|Clearance (CL) for Cisplatin|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of blood from which drug can be completely removed per unit of time. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter/hr||95% Confidence Interval|Geometric Mean
96926|NCT00842244|Secondary|Apparent Oral Clearance (CL/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. CL/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because CL/F could not be accurately estimated.||Liter/hr||95% Confidence Interval|Geometric Mean
96927|NCT00842244|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Plasma decay half life for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||hrs||Standard Deviation|Mean
96928|NCT00842244|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUC (0 - ∞)] for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. AUC (0 - ∞) for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||ng*hr/mL||95% Confidence Interval|Geometric Mean
96929|NCT00842244|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours. AUC (0-24) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Results for axitinib were normalized to axitinib 5 mg dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
96930|NCT00842244|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Capecitabine, Capecitabine's Metabolites and Cisplatin|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR, 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram*hour/milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
96963|NCT00841906|Primary|This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.|This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.|Lab Night|All participants that completed the overnight portion of the study were analyzed.||minutes||Standard Deviation|Mean
96931|NCT00842244|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Tmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Tmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||hrs||Full Range|Median
96932|NCT00842244|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Cmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Cmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-fluorouracil [5-FU], 5-deoxy-5-fluorouridine [5-DFUR] and 5-deoxy-5-fluorocytidine [5-DFC]) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on Cycle 1 (C1) Day -1 (D-1), C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.||nanogram/milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
96933|NCT00842244|Other Pre-specified|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Cisplatin and Capecitabine|MTD = highest dose at which no more than 30 percent (%) of 12 participants experience DLT during Cycle 1. DLT = GR2 proteinuria; GR3 NHT (excluding alopecia and those that can be controlled with appropriate treatment)for >=7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile NP/NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment-related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.||mg|||Number
96934|NCT00842244|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)|DLT = Grade (GR) 2 proteinuria; GR3 nonhematological toxicity (NHT) (excluding alopecia and those that can be controlled with appropriate treatment) for greater than or equal to (>=)7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile neutropenia (NP) or NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.||participants|||Number
96935|NCT00842231|Primary|Reading Acuity and Speed|Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD).|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.||words per minute||95% Confidence Interval|Least Squares Mean
96936|NCT00842231|Primary|Contrast Sensitivity|Contrast Sensitivity (CS) differences between subjects tested with full correction & spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) & mesopic conditions (with & without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS.|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.||Logrithmic Units||Standard Deviation|Mean
96937|NCT00842231|Primary|High and Low Contrast Acuity|Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision).|Day of study visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.||logMAR||Standard Deviation|Mean
96938|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 4|ITT Population||Percent change in % of BSA affected||Standard Deviation|Mean
96939|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)|Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||Percent change in scores on a scale||Standard Deviation|Mean
96940|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for Subject Global Assessment were evaluated; not all participants returned for every study visit.||participants|||Number
96941|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for plaque thickness were evaluated; not all participants returned for every study visit.||participants|||Number
96942|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for scaling were evaluated; not all participants returned for every study visit.||participants|||Number
96943|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for erythema were evaluated; not all participants returned for every study visit.||participants|||Number
96944|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Baseline (Week 0) and Week 4|ITT Population Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||participants|||Number
96945|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Week 1 and Week 4|ITT Population. Participants who returned for the visit specified (Week 1 and/or 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.||participants|||Number
96946|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 2|ITT Population||Percent change in % of BSA affected||Standard Deviation|Mean
96947|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)|Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.|Baseline (Week 0) and Week 2|ITT Population. Participants who returned for the visit specified (Week 2) and/or provided an assessment of pruritis were evaluated; not all participants returned for every study visit.||Percent change in scores on a scale||Standard Deviation|Mean
96964|NCT00841906|Primary|This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.||Lab Night|All participants that completed the overnight portion of the study were analyzed.||events/hour||Standard Deviation|Mean
96948|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
96949|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
96950|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Week 2|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
96951|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Week 2|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
96952|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.||participants|||Number
96953|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|ITT Population. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.||participants|||Number
96954|NCT00842153|Primary|Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|Intent-to-Treat (ITT) Population: all enrolled participants. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.||participants|||Number
96955|NCT00842075|Secondary|Weight Change After 28 Days Intervention Period|Mean weight change after 28 days intervention period|28 days|||kg||Standard Deviation|Mean
96956|NCT00842075|Primary|HbA1c Value After 28 Days|HbA1c values 28 days after randomization|28|pilot study||HbA1c %||Standard Deviation|Mean
96957|NCT00842023|Other Pre-specified|Serum Levels of Cystatin-C|Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.|Baseline, 24 hours, 48 hours|Only participants with available data were assessed for this outcome measure.||ng/mL||Standard Deviation|Mean
96958|NCT00842023|Other Pre-specified|Inflammatory Markers|Interleukin-6|48 hours|Only participants with available data were assessed for this outcome measure.||pg/mL||Standard Error|Mean
96959|NCT00842023|Primary|Renal Function by Serum Creatinine|Serum creatinine values and changes in serum creatinine|Baseline, 24 hours, 48 hours|||mg/dL||Standard Deviation|Mean
96960|NCT00841971|Secondary|Need for Additional Antifungal Therapy||90 days post enrollment|||participants|||Number
96961|NCT00841971|Primary|Frequency of Fungal Infection||90 days post enrollment|||participants|||Number
96962|NCT00841906|Secondary|The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory.|"The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of good quality data needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician."|overnight|||percentage of good Study Indicator||Standard Deviation|Mean
96965|NCT00841906|Primary|This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.||Lab Night|All participants that completed the overnight portion of the study were analyzed.||events||Standard Deviation|Mean
96966|NCT00841815|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
96967|NCT00841815|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
96968|NCT00841815|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
96969|NCT00841776|Secondary|Median Change in Noninflammaotry Acne Counts|Median Change in Noninflammaotry Acne Counts|Baseline, Weeks 2, 4, 8, 12, and 16|||Noninflammatory lesion counts||Inter-Quartile Range|Median
96970|NCT00841776|Secondary|Median Change in Inflammatory Acne Lesion Counts|Median Change in Inflammatory Acne Lesion Counts|Baseline, Weeks 2, 4, 8, 12, and 16|ITT||Lesion Counts||Inter-Quartile Range|Median
96971|NCT00841776|Secondary|Median Change in Total Acne Lesions|Median Change in Total Acne Lesions|Baseline, Weeks 2, 4, 8, 12, and 16|ITT||Total Acne Lesion Counts||Inter-Quartile Range|Median
96972|NCT00841776|Secondary|Median Change in Erythromycin-resistant P. Acne Counts|Total colony forming units of erythromycin-resistant p. acnes.|Baseline, Weeks 2, 4, 8, 12, and 16|ITT||Erythromycin-resistant P. acne counts||Inter-Quartile Range|Median
96973|NCT00841776|Secondary|Median Change in Clindamycin Resistant P. Acne.|Median change in total colony forming units of clindamycin resistant p. acne.|Baseline, Weeks 2, 4, 8, 12, 16|ITT||Clindamycin- resistant P. acne counts||Inter-Quartile Range|Median
96974|NCT00841776|Primary|Median Change in Total Propionibacterium Acne (P.Acne) Counts|Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.|Baseline, Weeks 2, 4, 8, 12, & 16|||P. acne counts||Inter-Quartile Range|Median
96975|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titers from baseline as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis Set population.||Percentages of participants||95% Confidence Interval|Number
96976|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2 as determined by HI, MN and SRH assays.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.||Percentages of participants||95% Confidence Interval|Number
96977|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 Vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Ratios (GMRs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI,MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis set population.||Ratios||95% Confidence Interval|Geometric Mean
96978|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|"To evaluate the immunogenicity of two doses of MF59-eH5N1, each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Areas (GMAs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis Set population.||Areas (mm^2)||95% Confidence Interval|Geometric Mean
96979|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Titers (GMTs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.||Titers||95% Confidence Interval|Geometric Mean
96980|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titer from baseline, as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22 and day 64/day22)|This analysis was performed on the Full Analysis Set population||Percentages of participants||95% Confidence Interval|Number
96995|NCT00841659|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
96981|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain)|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2, as determined by HI, MN and SRH assays.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Percentages of participants||95% Confidence Interval|Number
96982|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Ratio(GMRs) against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22, day 64/day43)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Ratios||95% Confidence Interval|Geometric Mean
96983|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Monovalent Influenza Virus Vaccine (aH5N1)|"To evaluate the immunogenicity of two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1), in terms of Geometric Mean Areas (GMAs) as determined by Single Radial Haemolysis(SRH) assay.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Areas (mm^2)||95% Confidence Interval|Geometric Mean
96984|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Titers(GMTs) against the homologous A/Vietnam/1194/2004 strain, as determined by hemagglutination Inhibition(HI) assay and Microneutralization(MN) assay.|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.||Titers||95% Confidence Interval|Geometric Mean
96985|NCT00841763|Secondary|The Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine|To evaluate the safety and tolerability profile of two dose of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV), in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety set population||Participants|||Number
96986|NCT00841763|Primary|Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine|To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) pandemic influenza vaccine (MF59-eH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety Set population||Participants|||Number
96987|NCT00841698|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
96988|NCT00841698|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
96989|NCT00841698|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
96990|NCT00841672|Secondary|Blood Pressure Control|Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study|End of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues||Percentage of participants|||Number
96991|NCT00841672|Secondary|Diastolic Blood Pressure Response|Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues All randomized patients who received the study medication. The measurement at Week 8 was used unless it was not available, in which case, the last observation carried forward was used.||Percentage of participants|||Number
96992|NCT00841672|Secondary|Systolic Blood Pressure Response|Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to GCP issues||Percentage of participants|||Number
96993|NCT00841672|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues||mm Hg||Standard Error|Least Squares Mean
96994|NCT00841672|Primary|Mean Sitting Systolic Blood Pressure (msSBP)|Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues||mm Hg||Standard Error|Least Squares Mean
96996|NCT00841659|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
96998|NCT00841555|Secondary|Time Spent in a Karnofsky Performance Status of 60-100%|Time spent in a KPS ≥70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS<70) or censored at the last date the patient was known with KPS ≥70.|up to 12-16 months|Kaplan-Meier analysis for time spent in a Karnofsky performance status (KPS) ≥70||months||95% Confidence Interval|Median
96999|NCT00841555|Secondary|Survival Time|All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient’s physician deems it in the patient’s interest not to continue or upon patient request.|up to time of death|||months||95% Confidence Interval|Median
97000|NCT00841555|Secondary|Time to Neuroradiological Evidence of Tumor Recurrence or Progression|As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect.|up to 12-16 months||||||
97001|NCT00841555|Primary|Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)|This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect.|up to 12-16 months|||mg/m^2|||Number
97002|NCT00841542|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97003|NCT00841542|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97004|NCT00841542|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97005|NCT00841412|Primary|Quality of Feeding Assistance Care Processes|"Research staff observed each participant during six meals per study phase. Research staff documented the total amount of staff time spent providing feeding assistance and each type of assistance per resident per meal. These data were used to construct standardized feeding assistance care quality indicators wherein the number of resident meal observations was variable. For example, one indicator was defined as: Percentage of meals during which resident intake was below 50% and staff offered and alternative to the served meal. Thus, the denominator for total number of observed meals scored varied by indicator. There were multiple indicators; thus, there is inadequate space to provide an adequate description of each measure and the corresponding scoring rules here. Please refer to published papers for a complete description of all outcome measures."|3 month intervention and 3 month follow up periods|Each participants was observed during six scheduled meals per person per study phase. A total of 130 participants completed all study phases and had complete data for analyses.||percentage of meal observations|Participants||Number
97006|NCT00841321|Secondary|Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration.|"The Perceived Deficits Questionnaire (PDQ), a standardized questionnaire in which the subject reports on his or her cognitive function; Measure total score Range (0 best - 80 worse) Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ), in which the family member who was most aware of the participant's cognitive deficits reports on the subject's cognitive deficits; measure total score range (0 best - 60 worse) 'and the Community Integration Questionnaire (CIQ) in which the subject reports his or her degree of social integration; range (0 worst - 32 best); measure total score.~Sub-scales for these 3 measures were not used for outcome measures only total scores."|12 weeks|||units on a scale||Standard Deviation|Mean
97007|NCT00841321|Primary|Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.|"Performance at exit adjusted for baseline performance on 4 neuropsychological tests:~STROOP(Victoria version):Tests attention&executive function. Outcome is the interference condition condition; time needed to name the colors in which words (which are names of colors) are printed. Words and colors are mismatched.~CaliforniaVerbalLearningTest- II: Tests verbal/learning/memory. Outcome number of words (shopping list) remembered after 20 min delay with no cues.~PacedAuditorySerialAdditionTest:Tests working memory/sustained attention. Outcome is the number of correct responses to recording giving numbers every 2 sec. Last 2 numbers must be added together before the next number.~ControlledOralWordAssociationTest:Tests letter fluency. Outcome number of words produced in one minute for each of 3 letters.~Measures reported as Z-scores based on the available population norms for each test; range -infinite +infinite; 0 average; -1=1std below average; +1=1std above average."|12 weeks|Data of all 120 participants was analyzed. For subjects with missing exit values (1 placebo, 2 ginkgo) the baseline measures were carried forward in the analysis.||z-scores||Standard Deviation|Mean
97008|NCT00841269|Secondary|A Secondary Outcome Measure Includes a Change in YMRS Score||1 year||||||
97009|NCT00841269|Primary|The Primary Neuroimaging Outcome Will be Changes in 3T MRS B-NTP in the Anterior Cingulate.||1 year||||||
97010|NCT00841269|Primary|Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment|The CDRS-R is a 17-item scale, with items rated for severity on a 5 point scale for 3 items and on a 7 point scale for 14 items (possible total score from 17 to 113). Ratings are completed by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission.|1 year|||Units on a scale||Full Range|Mean
97011|NCT00841204|Primary|Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis||µg/g tissue||Standard Deviation|Mean
97066|NCT00840281|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|||ng*h/mL||Standard Deviation|Mean
97012|NCT00841204|Primary|Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis||µg/g tissue||Standard Deviation|Mean
97013|NCT00841204|Primary|Sulindac Concentration in the Nevi (Moles)||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis||µg/g tissue||Standard Deviation|Mean
97014|NCT00841204|Secondary|Association Between Plasma and Target Tissue Drug Levels||8 weeks||||||
97015|NCT00841204|Secondary|Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi||8 weeks||||||
97016|NCT00841204|Secondary|Sulindac Effects on Apoptosis in Atypical Nevi||8 weeks||||||
97017|NCT00841087|Secondary|Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
97018|NCT00841087|Secondary|Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
97019|NCT00841087|Secondary|Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||participants|||Number
97020|NCT00841087|Secondary|Change in Body Weight|Observed change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||kg||Standard Deviation|Mean
97021|NCT00841087|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
97022|NCT00841087|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00−05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
97023|NCT00841087|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Episodes /year of patient exposure|||Number
97024|NCT00841035|Primary|Epidermal Growth Factor Receptor Signaling(EGFR) in the Presence of Pancreatic Tumor Related to the Mechanism to Erlotinib.|It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.|During the trial only||||||
97025|NCT00841035|Secondary|The Secondary Objectives Include Analysis of Recurrence-free and Overall Survival and the Development of a Predictive Assay for Response to Erlotinib Based on Selected Bio-markers in Endoscopic Ultrasound-Fine-needle Aspiration Specimens.|The measurement was to be the average length of time before recurrence of disease and the overall survival time. As well as time from recurrence to death in subjects.This time will be measure in months till recurrence and them months to death.|End of the study|Due to the closure of the study before this endpoint could be met, there are no subjects analyzed.|||||
97026|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|90 days post operative|Include the participants who finished the Acute SF 12 health survey at 90 days follow-up||units on a scale||Inter-Quartile Range|Median
97027|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|30 days post operative|Include the participants who finished the Acute SF 12 health survey at 30 days follow-up||units on a scale||Inter-Quartile Range|Median
97028|NCT00840996|Secondary|Duration of Hospitalization|Length of hospital stay will be recorded in days.|At discharge|3 patients in the placebo group did not have duration of hospital stay recorded.||days||Inter-Quartile Range|Median
97029|NCT00840996|Secondary|Postoperative Nausea and Vomiting (PONV)|Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.|post op day one and two or till hospital discharge|We only have 39 and 36 patients for comparison of PONV at day two after surgery, since the rest were discharged by that time||participants|||Number
97067|NCT00840281|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97068|NCT00840216|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97030|NCT00840996|Secondary|Number of Participants With Any Major 30-day Post Operative Complications|The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission.|30 days after surgery|||participants|||Number
97031|NCT00840996|Primary|Opioid Medication Requirement, mg in IV Morphine Equivalent|Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents|through postoperative day 2 (or discharge, if earlier)|||mg IV morphine equivalent||Standard Deviation|Mean
97032|NCT00840996|Primary|Mean Pain Scores|The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).|From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).|||verbal response scores||Standard Deviation|Mean
97033|NCT00840879|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
97034|NCT00840879|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.||µg*h/mL||Standard Deviation|Mean
97035|NCT00840879|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.||µg/mL||Standard Deviation|Mean
97036|NCT00840866|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97037|NCT00840866|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97038|NCT00840866|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97039|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/h/mL||Standard Deviation|Mean
97040|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97041|NCT00840840|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97042|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97043|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97044|NCT00840840|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97045|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the a) Proportional Odds of Higher Receptive Needle Sharing and b) Mean Score of the Injection Risk Index (IRI).|"For a) we asked: “In the past month, how often have you used a needle or syringe that you knew or suspected had been used before by someone else?” (possible responses: 1=never, 2=sometimes, 3=about half the time, 4=often, 5=always), with a higher response indicating a higher risk.~Analyzed using ordinal logistic regression with frequency of receptive needle sharing as outcome variable and intervention group, time point, and interaction between the two as main effects of interest.~For b)IRI calculated based on: receptive needle sharing, sharing a bottlecap/spoon/cooker, sharing cotton filter for a needle, or rinse water after someone else has used it, and using a used syringe to divide drugs. Score constructed by calculating average score between responses to injection risk indicators, with higher score representing higher risk. We analyzed using gamma regression with IRI as outcome and intervention group, time point and interaction between the two as main effects of interest"|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||11/2012||||
97069|NCT00840216|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97070|NCT00840216|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97046|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the a)Mean Number of Unprotected Sex Acts With Clients and b)Ratio of Unprotected Sex Acts With Clients (Relative to the Number of Sex Acts With Clients.|The analytic method used for a) was negative binomial regression with the number of unprotected sex acts with clients as the outcome variable and intervention group, time point (baseline, 4-, 8-, and 12-months), and the interaction between the two as the main effects of interest. Similarly, for part b) we used negative binomial regression, except that in this case log(total number of sex acts with clients) was used as an offset variable in order to create the ratio of unprotected sex acts (relative to total number of sex acts).|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||11/2012||||
97047|NCT00840658|Primary|Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.|"Combined incidence for HIV/STI was calculated over the 12-month study period and included only those who a) had at least one follow-up visit and b) at baseline tested negative for HIV and any of the aforementioned STIs.~In the calculations we accounted for the time each participant spent at risk of HIV/any STI during the follow-up period, by using available information on each participant for each time point (i.e. baseline, 4-, 8-, and 12-months was used).~The analytic method used for this outcome analysis was Poisson regression with robust variance estimation. The outcome variable was a binary variable indicating whether a participant has contracted HIV or a new STI during the 12-month follow-up period. The primary factor of interest was the intervention group. The log (“time spent at risk of HIV/any STI”) was used as an offset variable in order to account for the time spent at risk of HIV/any STI by each participant."|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline|||incidence density per 100 person years|||Number
97048|NCT00840632|Secondary|AUC0-t - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|||pg*h/mL||Standard Deviation|Mean
97049|NCT00840632|Secondary|AUC0-inf - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|||pg*h/mL||Standard Deviation|Mean
97050|NCT00840632|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|||pg/mL||Standard Deviation|Mean
97051|NCT00840632|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg*h/mL||Standard Deviation|Mean
97052|NCT00840632|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg*h/mL||Standard Deviation|Mean
97053|NCT00840632|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg/mL||Standard Deviation|Mean
97054|NCT00840476|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.||µg*h/mL||Standard Deviation|Mean
97055|NCT00840476|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.||µg*h/mL||Standard Deviation|Mean
97056|NCT00840476|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.||µg/mL||Standard Deviation|Mean
97057|NCT00840450|Secondary|Progression-free-survival at 12 Months|This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.|up to 12 months|Based on intent-to-treat population.||percentage of participants|||Number
97058|NCT00840450|Secondary|Progression-free-tolerance|This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment.|12 weeks|Based on intent-to-treat population.||percentage of participants|||Number
97059|NCT00840450|Primary|the Best Overall Clinical Response|This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.|12 weeks|The analysis is based on the intent-to-treat population.||percentage of participants|||Number
97060|NCT00840411|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97061|NCT00840411|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|AUCinf could not be estimated for some subjects.||ng*h/mL||Standard Deviation|Mean
97062|NCT00840411|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97063|NCT00840294|Secondary|Overall Infectious Complication Rate Following Prostate Biopsy|To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy|Within 24 hours of biopsy|Subjects with complete data are included.||percentage of participants||95% Confidence Interval|Number
97064|NCT00840294|Primary|Change in PSA Level From Baseline|"To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization.~Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline)."|At baseline and 21-45 days after randomization|Subjects with complete data are included||log ng/mL||Standard Deviation|Mean
97071|NCT00840203|Secondary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|AUC0-t results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97072|NCT00840203|Secondary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects||ng*h/mL||Standard Deviation|Mean
97073|NCT00840203|Secondary|Cmax - Maximum Observed Concentration|Cmax results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97074|NCT00840203|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97075|NCT00840203|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects||ng*h/mL||Standard Deviation|Mean
97076|NCT00840203|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97077|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97078|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97079|NCT00840099|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97080|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97081|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97082|NCT00840099|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97083|NCT00840086|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient’s daily activities. Mild AEs: No or transient symptoms, no interference with the patient’s daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.||events|||Number
97084|NCT00840086|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.|The safety analysis set includes all 150 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 148 subjects had 50 exposure days (EDs).||N with Inhibitors / N with ≥50 EDs|||Number
97085|NCT00840073|Secondary|AUC0-72 - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng*h/mL||Standard Deviation|Mean
97086|NCT00840073|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng/mL||Standard Deviation|Mean
97087|NCT00840073|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng*h/mL||Standard Deviation|Mean
97088|NCT00840073|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all data from completed subjects could be used to determine AUC0-inf.||ng*h/mL||Standard Deviation|Mean
97121|NCT00839800|Secondary|Morning Peak Expiratory Flow (PEF)|The mean value from a 52-week treatment period.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Liter/minute (L/min)||Standard Deviation|Mean
97089|NCT00840073|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.||ng/mL||Standard Deviation|Mean
97090|NCT00840060|Primary|Number of Verb Structures Per Utterance|Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.|Pre-treatment, post-treatment, 1-month follow-up|||Novel verb structures per utterance||Standard Deviation|Mean
97091|NCT00840060|Primary|Language Sample Analysis|Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.|Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.|Language samples were collected for all children participating in either treatment condition.||Percentage of utterances||Standard Deviation|Mean
97092|NCT00839930|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97093|NCT00839930|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97094|NCT00839930|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97095|NCT00839917|Other Pre-specified|Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97096|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 5 days postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97097|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97098|NCT00839917|Other Pre-specified|Percentage of Participants With Any Systemic Adverse Experience|"An adverse experience is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences."|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97099|NCT00839917|Other Pre-specified|Percentage of Participants With Zoster-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97100|NCT00839917|Other Pre-specified|Percentage of Participants With Rubella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97101|NCT00839917|Other Pre-specified|Percentage of Participants With Varicella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97102|NCT00839917|Other Pre-specified|Percentage of Participants With Measles-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination||percentage of participants|||Number
97103|NCT00839917|Secondary|Geometric Mean Titer of VZV (gpELISA) Antibodies|Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||gpELISA units/mL||90% Confidence Interval|Geometric Mean
97104|NCT00839917|Secondary|Geometric Mean Titer of Rubella Antibodies|Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||IU/mL||90% Confidence Interval|Geometric Mean
97105|NCT00839917|Secondary|Geometric Mean Titer of Mumps Antibodies|Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||Units/mL||90% Confidence Interval|Geometric Mean
97106|NCT00839917|Secondary|Geometric Mean Titer of Measles Antibodies|Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||mIU/mL||90% Confidence Interval|Geometric Mean
97107|NCT00839917|Primary|Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL|Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
97108|NCT00839917|Primary|Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL|Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
97109|NCT00839917|Primary|Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL|Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
97110|NCT00839917|Primary|Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL|Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.||percentage of participants||90% Confidence Interval|Number
97111|NCT00839800|Secondary|Asthma Control Questionnaire (ACQ)|The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||units on a scale||Standard Deviation|Mean
97112|NCT00839800|Secondary|Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)|An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of asthma-control days||Standard Deviation|Mean
97113|NCT00839800|Secondary|Percentage of As-needed-free Days|An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of as-needed-free days||Standard Deviation|Mean
97114|NCT00839800|Secondary|Symptom-free Days (no Symptoms and no Awakenings)|A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||symptom-free days||Standard Deviation|Mean
97115|NCT00839800|Secondary|The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations|Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of participants|||Number
97116|NCT00839800|Secondary|Nights With Awakening(s) Due to Asthma Symptoms|The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Nights With Awakening(s)||Standard Deviation|Mean
97117|NCT00839800|Secondary|Asthma Symptom Score|The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||units on a scale||Standard Deviation|Mean
97118|NCT00839800|Secondary|Use of As-needed Medication|The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||inhalations/day||Standard Deviation|Mean
97119|NCT00839800|Secondary|Forced Expiratory Volume in One Second (FEV1)|The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Liter (L)||Standard Deviation|Geometric Mean
97120|NCT00839800|Secondary|Evening PEF|The mean value from a 52-week treatment period.|2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||L/min||Standard Deviation|Mean
97122|NCT00839800|Secondary|Number of Asthma Exacerbations|Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||Asthma exacerbations|||Number
97123|NCT00839800|Primary|The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study|Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.|week 52|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.||percentage of participants|||Number
97124|NCT00839540|Primary|Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).~These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M)."|Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug|Each subject received drug and had serum samples drawn at pre-treatment, 1.5h, 12h, and 24h after dosing.||Log inhibition|Participants||Number
97125|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 104 and Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).||Kilograms||Standard Deviation|Mean
97126|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
97127|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
97128|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed.||Participants|||Number
97129|NCT00839527|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population||Weeks||95% Confidence Interval|Median
97130|NCT00839527|Secondary|Change From Baseline in FPG at Week 104 and Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).||Millimoles per liter (mmol/L)||Standard Deviation|Mean
97131|NCT00839527|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
97191|NCT00839098|Primary|Power Wheelchair Usage|Power wheelchair usage was measured by the sum of distances that the power wheelchair traveled (km) divided by the duration of the wheelchair being occupied a day (hr). The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||km/hour||Standard Deviation|Mean
97132|NCT00839527|Secondary|Change From Baseline in HbA1c at Week 104 and Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).||Percentage of HbA1c in the blood||Standard Deviation|Mean
97133|NCT00839527|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
97134|NCT00839436|Other Pre-specified|Change: CD4/CD8 T Cell Cts After CYT107; in Immunophenotype (Naive, Memory, Regulatory T Cell Subsets) & Amp; Antigen-specific T Cell Function After CYT107; in T Cell Activation/Proliferation Status & Amp; TCR Repertoire After CYT107; ...||48 weeks per patient with a 3-4 year enrollment period||||||
97135|NCT00839436|Primary|Adverse Events and Toxicities Associated With CYT107.||48 weeks per patient with a 3-4 year enrollment period|||Events|||Number
97136|NCT00839423|Secondary|Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)||Week 6|FAS, LOCF||percentage of patients|||Number
97137|NCT00839423|Secondary|Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 6|FAS, LOCF||percentage of patients|||Number
97138|NCT00839423|Secondary|Change in Clinical Status Using CGI-I Score at Week 6|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
97139|NCT00839423|Secondary|Change From Baseline in CGI-S Score After 6 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
97140|NCT00839423|Secondary|Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
97141|NCT00839423|Secondary|Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment|The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF||units on a scale||Standard Error|Mean
97142|NCT00839423|Secondary|Change From Baseline in MADRS Total Score After 1 Week of Treatment||Baseline and Week 1|FAS, LOCF. Please note that 1 patient in each Vortioxetine group did not have a valid MADRS assessment at Week 1, but were included in the analysis because they had a valid MADRS assessment after Week 1.||units on a scale||Standard Error|Mean
97143|NCT00839423|Primary|Change From Baseline in MADRS Total Score After 6 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid baseline and one valid post-baseline assessment of the MADRS total score; Last Observation Carried Forward (LOCF)||units on a scale||Standard Error|Mean
97144|NCT00839319|Primary|Intratesticular Testosterone (ITT-T)||10 days|||IU/L||Inter-Quartile Range|Median
97145|NCT00839319|Primary|Serum Follicle Stimulating Hormone (FSH)||10 days|||IU/L||Inter-Quartile Range|Median
97146|NCT00839319|Primary|Serum Luteinizing Hormone (LH)||10 days|||IU/L||Inter-Quartile Range|Median
97147|NCT00839319|Primary|Serum Testosterone (T)||10 days|Analysis per protocol. Due to nonnormality, the data were expressed as medians and 25th and 75 percentiles. Analysis of both baseline and end of treatment hormone concentrations performed on 31 subjects who completed all study procedures and who suppressed serum LH below the lower limit of normal at end of treatment.||nmol/liter||Inter-Quartile Range|Median
97283|NCT00837967|Primary|Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 140 min after start dosing for each treatment day|||mg/dLiters||Standard Deviation|Mean
97148|NCT00839306|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.||Percentage of Participants|||Number
97149|NCT00839306|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT||Percentage of Participants|||Number
97150|NCT00839241|Secondary|Lymphocytes||Day 8 postop|||percentage of white blood cells||Standard Deviation|Mean
97151|NCT00839241|Secondary|Lymphocytes||Day 5 postop|||percentage of white blood cells||Standard Deviation|Mean
97152|NCT00839241|Secondary|Lymphocytes||Day 1 postop|||percentage of white blood cells||Standard Deviation|Mean
97153|NCT00839241|Secondary|Lymphocytes||Baseline|||percentage of white blood cells||Standard Deviation|Mean
97154|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 8 postop|||10^3/uL||Standard Deviation|Mean
97155|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 5 postop|||10^3/uL||Standard Deviation|Mean
97156|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 1 postop|||10^3/uL||Standard Deviation|Mean
97157|NCT00839241|Secondary|Leucocyte Particle Concentration||Baseline|||10^3/uL||Standard Deviation|Mean
97158|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 8 postop|||percentage of blood volume||Standard Deviation|Mean
97159|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 5 postop|||percentage of blood volume||Standard Deviation|Mean
97160|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 1 postop|||percentage of blood volume||Standard Deviation|Mean
97161|NCT00839241|Secondary|Erythrocyte Volume Fraction||Baseline|||percentage of blood volume||Standard Deviation|Mean
97162|NCT00839241|Secondary|Hemoglobin||Day 8 postop|||g/dL||Standard Deviation|Mean
97163|NCT00839241|Secondary|Hemoglobin||Day 5 postop|||g/dL||Standard Deviation|Mean
97164|NCT00839241|Secondary|Hemoglobin||Day 1 postop|||g/dL||Standard Deviation|Mean
97165|NCT00839241|Secondary|Hemoglobin||Baseline|||g/dL||Standard Deviation|Mean
97166|NCT00839241|Secondary|TNF-Alpha||Day 8 postop|||pg/mL||Standard Deviation|Mean
97167|NCT00839241|Secondary|TNF-Alpha||Day 5 postop|||pg/mL||Standard Deviation|Mean
97168|NCT00839241|Secondary|TNF-Alpha||Baseline|||pg/mL||Standard Deviation|Mean
97169|NCT00839241|Secondary|Interleukin-10||Day 8 postop|||pg/mL||Standard Deviation|Mean
97170|NCT00839241|Secondary|Interleukin-10||Day 5 postop|||pg/mL||Standard Deviation|Mean
97171|NCT00839241|Secondary|Interleukin-10||Baseline|||pg/mL||Standard Deviation|Mean
97172|NCT00839241|Secondary|Interleukin-6||Day 8 postop|||pg/mL||Standard Deviation|Mean
97173|NCT00839241|Secondary|Interleukin-6||Day 5 postop|||pg/mL||Standard Deviation|Mean
97174|NCT00839241|Secondary|Interleukin-6||Baseline|||pg/mL||Standard Deviation|Mean
97175|NCT00839241|Secondary|Interleukin-4||Day 8 postop|||pg/mL||Standard Deviation|Mean
97176|NCT00839241|Secondary|Interleukin-4||Day 5 postop|||pg/mL||Standard Deviation|Mean
97177|NCT00839241|Secondary|Interleukin-4||Baseline|||pg/mL||Standard Deviation|Mean
97178|NCT00839241|Secondary|Interleukin-2||Day 8 postop|||pg/mL||Standard Deviation|Mean
97179|NCT00839241|Secondary|Interleukin-2||Day 5 postop|||pg/mL||Standard Deviation|Mean
97180|NCT00839241|Secondary|Interleukin-2||Baseline|||pg/mL||Standard Deviation|Mean
97181|NCT00839241|Secondary|Interferon Gamma||Day 8 postop|||pg/mL||Standard Deviation|Mean
97182|NCT00839241|Secondary|Interferon Gamma||Day 5 postop|||pg/mL||Standard Deviation|Mean
97183|NCT00839241|Secondary|Interferon Gamma||Baseline|||pg/mL||Standard Deviation|Mean
97184|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 8 postop|||Percent||Standard Deviation|Mean
97185|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 5 postop|||Percent||Standard Deviation|Mean
97186|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Baseline|||Percent||Standard Deviation|Mean
97187|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 8 postop|||total number of cells * 10^5/mL||Standard Deviation|Mean
97188|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 5 postop|||total number of cells * 10^5/mL||Standard Deviation|Mean
97189|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Baseline|||total number of cells * 10^5/mL||Standard Deviation|Mean
97190|NCT00839098|Primary|Wheelchair Occupancy|Wheelchair occupancy was measured by the sum of duration that the seat of the wheelchair was occupied. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||hours||Standard Deviation|Mean
97282|NCT00837967|Primary|Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia’s formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||ms||Standard Deviation|Mean
97192|NCT00839098|Primary|Frequency of Power Seat Function Usage|Frequency of power seat function usage was measured by the number of times of changing tilt and recline angles averaged by the duration that the participant occupied the wheelchair per day. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||times/hour||Standard Deviation|Mean
97193|NCT00839098|Secondary|Questionnaire Responses: Independence in Community|This outcome was measured in three aspects: Physical Independence, Cognitive Independence, and Mobility, using the three of the subscales of Craig Handicap Assessment and Reporting Technique Scale. The scores of each subscale has to be calculated with specific formula and weight based on the manual. The range of each subscale score are: Physical Independence: 28-100; Cognitive Independence: 15-100; and Mobility: 16-100. A higher score indicates greater independence. The analyzed results of the difference between the measurements at the end of 2nd week and 8th week were shown here.|At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||units on a scale||Standard Deviation|Mean
97194|NCT00839098|Secondary|Questionnaire Responses: Psychological Impacts of Assistive Devices Scale|This tool is to measure perceived psychological impact of using an assistive device. It consists of three subscales, Competence (12 items), Adaptability (6 items), and Self-esteem (8 items). Each item is scored on a likert scale from -3 (decreases) to + 3 (increases). The total score is the sum of all 26 items, ranging from -78 to 78. A higher positive score indicates more positive impact. A negative score indicates negative impact. The differences between the measurements taken at the end of 2nd week (end of baseline) and the end of 8th week (end of intervention period) are reported here to show the intervention effect.|At the end of every two weeks|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||units on a scale||Standard Deviation|Mean
97195|NCT00839098|Secondary|Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)|General Discomfort Assessment (GD) and Discomfort Intensity Rating (DI) are two sub-scales of TAWC. Higher scores indicate greater discomfort. GD consists of 8 discomfort statements and 5 comfort statements. The statements are rated on a seven point Likert scale, from strongly disagree to strongly agree of points from 1-7 (total score: 13-91). DI includes seven body areas (back, neck, buttocks, legs, arms, feet, and hands) and overall discomfort level, rated for a degree of discomfort intensity on a scale of 0 (no discomfort) to 10 (severe discomfort). Space is also included for the user to list additional body areas. DI scores may range from 0 to more than 80, depending on whether the participant reported additional areas of discomfort. Although GD and DI were measured daily, the data were average for each two-week period. The average GD and DI of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|||units on a scale||Standard Deviation|Mean
97196|NCT00839098|Primary|Compliance Rate|Compliance rate is a measure of compliance with the recommendation of using powered seating functions (moderate or maximum range of tilt, at least once every hour, for 2 minutes). The participant had to follow the recommended position, duration, and frequency to be considered as compliant and performed successful repositioning exercise. The compliance rate of a participant was the number of successful repositioning exercise divided by the sum of the number of successful repositioning exercise and missed repositioning exercise. The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.||Percentage of participants' compliance||Standard Deviation|Mean
97197|NCT00839072|Secondary|Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]||24 hours|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng*h/mL||Standard Deviation|Mean
97198|NCT00839072|Secondary|Apparent Terminal Elimination Half-Life [T½el]|The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||Hours||Standard Deviation|Mean
97199|NCT00839072|Secondary|Time of Maximum Measured Plasma Concentration (Tmax)||72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||hours||Full Range|Median
97200|NCT00839072|Primary|Bioequivalence Based on AUC∞|AUC∞ = Area under the concentration-time curve extrapolated to infinity|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng*h/mL||Standard Deviation|Mean
97201|NCT00839072|Primary|Bioequivalence Based on AUCT|AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng*h/mL||Standard Deviation|Mean
97202|NCT00839072|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.||ng/mL||Standard Deviation|Mean
97203|NCT00838929|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Vorinostat and Radiotherapy in Patients With Brain Metastases.|"To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Vorinostat and radiotherapy in patients with brain metastases.~The maximum tolerated dose (MTD) will be one dose below the DLT occurring in at least 1 out of 3 subjects.~Dose level -2: 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1: 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I: 200 mg PO qd (initial starting dose) Dose level II: 300 mg PO qd Dose level III: 400 mg PO qd"|Weekly during treatment On Last day of treatment (30 days after last drug dose) Follow-up (every 3 months)|||mg|||Number
97239|NCT00838513|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
97204|NCT00838916|Secondary|Albiglutide Plasma Concentrations at Week 8 and Week 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
97205|NCT00838916|Secondary|Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52|A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.|Baseline and Week 52|Glucose Profile Substudy Population: all participants who participated in the 24-hour glucose profile substudy . Only those participants with a value at Baseline and Week 52 were analyzed.||Millimoles per hour per liter (mmol.h/L)||Standard Deviation|Mean
97206|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Kilograms||Standard Deviation|Mean
97207|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Kilograms||Standard Error|Least Squares Mean
97208|NCT00838916|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
97209|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Participants|||Number
97210|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Participants|||Number
97211|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
97212|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
97280|NCT00837967|Primary|Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||beats/min||Standard Deviation|Mean
97213|NCT00838916|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.||Percentage of HbA1c in the blood||Standard Deviation|Mean
97214|NCT00838916|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide – insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
97215|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed.||Kilograms||Standard Deviation|Mean
97216|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 104|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.||Kilograms||Standard Error|Least Squares Mean
97217|NCT00838903|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.||Weeks||95% Confidence Interval|Median
97218|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.||Participants|||Number
97219|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.||Participants|||Number
97220|NCT00838903|Secondary|Change From Baseline in FPG at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
97221|NCT00838903|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
102268|NCT00795951|Primary|Diagnostic Performance: Quaternium-15|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
97222|NCT00838903|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed .|Baseline and Week 156|Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.||Percentage of HbA1c in the blood||Standard Deviation|Mean
97223|NCT00838903|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide – placebo, albiglutide – sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 104.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
97224|NCT00838682|Other Pre-specified|Duration of Hospital Stay||6wk|intention to treat (ITT)||days||Standard Deviation|Mean
97225|NCT00838682|Other Pre-specified|Mean Units of Blood Transfusion|In order to compare the total amount of blood transfusion, mean units of blood transfusion was used.|day 3|intention to treat (ITT)||Mean units of blood transfusion||Standard Deviation|Mean
97226|NCT00838682|Secondary|Death||6wk|intention to treat (ITT)||participants|||Number
97227|NCT00838682|Secondary|Surgery|"This sencodary endpoint surgery is the operation for bleeding control of peptic ulcer bleeding such as gastric or duodenal primary closure, and subtotal gastrectomy with/without vagotomy."|6wk|intention to treat (ITT)||participants|||Number
97228|NCT00838682|Secondary|Rebleeding After 3 Days|Rebleeding after 3 days was assessed by checking the patients from day 3 to discharge and bleeding event or regular follow-up after discharge to week 6.|6wk|intention to treat (ITT)||participants|||Number
97229|NCT00838682|Primary|Rebleeding Within 3 Days||day 3|intention to treat (ITT)||participants|||Number
97230|NCT00838630|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97231|NCT00838630|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97232|NCT00838630|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97233|NCT00838578|Primary|Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0||Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months|ITT population||participants|||Number
97234|NCT00838526|Secondary|Secondary Outcome Measures Will Include: Adverse Events, Electrocardiograms (ECGs), Laboratory Evaluations (Hematology, Blood Chemistry, Urinalysis, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs.|Information presented within Adverse Event information.|Baseline to Week 26||||||
97235|NCT00838526|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.||Percentage of Participants|||Number
97236|NCT00838526|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT||Percentage of Participants|||Number
97237|NCT00838513|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.||micrograms/mil||Standard Deviation|Mean
97238|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
97240|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
97241|NCT00838513|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
97242|NCT00838513|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
97243|NCT00838513|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeksend of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
97244|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
97245|NCT00838513|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.||10^9 cells/L||95% Confidence Interval|Least Squares Mean
97246|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.||#events/patient/day||Standard Deviation|Mean
97247|NCT00838513|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.||Percentage of Participants||95% Confidence Interval|Number
97248|NCT00838513|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
97249|NCT00838513|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.||Percentage of Participants||95% Confidence Interval|Number
97250|NCT00838331|Primary|The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow.|The primary outcome measures are changes in forearm blood flow (FBF) in recipients of fresh or stored RBC transfusions in response to acetylcholine. Secondary measures include changes in FBF with acetylcholine with or without L-NMMA, and changes in FBF with forearm exercise. In addition, flow mediated dilation (FMD) measurements will also be used to assess changes in brachial artery diameter before and after fresh vs aged RBC transfusions.|5 years|||mL / 100 mL / min||Standard Deviation|Mean
97251|NCT00838279|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97252|NCT00838279|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97253|NCT00838279|Primary|Cmax - Maximum Observed Concentration|Bioequivalence basd on Cmax|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97254|NCT00838201|Primary|Overall Survival Through Month 24||24 months|Full Analysis Set||Participants|||Number
97255|NCT00838162|Secondary|Fluctuation Index of TMC310911|Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration.|Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||Percent ng/mL||Standard Deviation|Mean
97256|NCT00838162|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC310911||Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).||ng/mL||Standard Deviation|Mean
97257|NCT00838162|Secondary|Predose Plasma Concentration (C0h) of TMC310911||Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).||ng/mL||Standard Deviation|Mean
97258|NCT00838162|Secondary|Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||ng.h/mL||Standard Deviation|Mean
97259|NCT00838162|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||hours||Full Range|Median
97260|NCT00838162|Secondary|Maximum Plasma Concentration (Cmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)||ng/mL||Standard Deviation|Mean
97261|NCT00838162|Secondary|Mean Changes From Baseline in CD4+ Cell Count||Baseline (Day 1), Day 8, Day 15|Intent-to-treat (ITT) Population - all randomized participants who received at least 1 dose of study medication (TMC310911)||x 1000000 cells/L||Standard Error|Mean
97262|NCT00838162|Secondary|Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period|Virologic response is a viral load test result below a chosen threshold value (less than 50 copies/mL, less than 400 copies/mL, or at least 1 log drop in viral load) at any timepoint during a 14-day treatment of 4 different dose regimens of TMC310911 coadministered with 100 mg ritonavir.|14 days|Intent-to-treat (ITT) Population- all randomized participants who received at least 1 dose of study medication (TMC310911)||Participants|||Number
97263|NCT00838162|Primary|Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)|The antiviral activity of TMC310911 is measured by the change in viral load from baseline in the 14 days of treatment following initiation of treatment with 4 different dosing regimens of TMC310911 coadministered with ritonavir.|Baseline (Day 1), Day 8, Day 15|Intent-to treat (ITT) population- participants who received at least 1 dose of study medication (TMC310911).||log10 copies/mL||Standard Error|Mean
97264|NCT00838136|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97265|NCT00838136|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97266|NCT00838136|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97267|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study.||percentage of participants|||Number
97268|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study.||percentage of participants|||Number
97269|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
97281|NCT00837967|Primary|Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||mmHg||Standard Deviation|Mean
97270|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
97271|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2|Abnormal ECG findings included maximum value of >=300 msec, maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval; maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
97272|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
97273|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2|Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
97274|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the safety analysis set (SAS) (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.||percentage of participants|||Number
97275|NCT00838097|Secondary|Number of Participants With Non-serious Adverse Drug Reactions (ADRs)|"An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied:~Fatal~Life threatening~Required or prolonged in-patient hospitalization~A persistent or significant disability/incapacity, or~A congenital anomaly/birth defect."|2 years|Full analysis set||participants|||Number
97276|NCT00838097|Secondary|Parathyroid Hormone Level by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set||pmol/L||Inter-Quartile Range|Median
97277|NCT00838097|Secondary|Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals|Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency.|Baseline and Months 1 to 24|Full analysis set||μg/kg/month||95% Confidence Interval|Geometric Mean
97278|NCT00838097|Secondary|Hemoglobin Concentration by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set||g/dL||95% Confidence Interval|Mean
97279|NCT00838097|Primary|Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)|An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).|2 years|Full Analysis Set||participants|||Number
102269|NCT00795951|Primary|Diagnostic Performance: Cl+Me-Isothiazolinone|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
97284|NCT00837967|Primary|Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day|||mEq/L||Standard Deviation|Mean
97285|NCT00837967|Primary|Adverse Events|Total number of adverse events|3 days|||adverse events|||Number
97286|NCT00837876|Secondary|Number of Patients With Worst Grade Toxicities|Number of patients with worst-grade toxicity at each of five grades (grade 1 to 5, with 5 most severe) following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death.|every 4 weeks and every 8 weeks in follow-up to resolution of toxicity|All patients who received treatment with the study drugs. One patient did not receive treatment.||participants|||Number
97287|NCT00837876|Secondary|Number of Patients With Progression-free Survival|Participants with progression-free survival at 4 months.|at 4 months|Patients with progression-free survival at 4 months. The remaining 17 patients were not available for evaluation at 4 months due to toxicity (5), disease progression (5), patient withdrawal (1),respiratory failure (1), study drug held more than 28 days (1), and no study drug (1.||participants|||Number
97288|NCT00837876|Secondary|Response Rate|Per RECIST criteria v. 1.0: measurable lesions: CR disappearance of target lesions, PR > 30% decrease in the sum of the longest diameter (LD) of target lesions, PD > 20% increase in the sum of the LD of target lesions or appearance of new lesions, SD neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 4 months|Participants who received treatment for 4 or more months. The remaining 10 participants received treatment for less than 4 months and were not evaluable.||participants|||Number
97289|NCT00837876|Primary|Number of Patients With Progression-free Survival|Number of patients with progression-free survival at 8 weeks|at 8 weeks|Patients who received treatment for >= 8 weeks. 14 study patients were treated for < 8 weeks due to toxicity (5), disease progression (5), did not receive study drug (1), respiratory failure (1), drug held more than 28 days (1), patient withdrawal (1). The remaining 13 participants did not have a progression-free survival at 8 weeks.||participants|||Number
97290|NCT00837824|Secondary|Plasma Globotriaosylceramide (GL-3)|This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level is defined as ≤ 7.03 µg/mL.|Evaluated at Baseline, Month 3, and Final Visit|"Fabrazyme 1mg/kg every 2 weeks: ITT population – 11 patients at baseline, 7 patients at Month 3, and 9 patients at Final Visit had Plasma GL-3 values.~Fabrazyme 3mg/kg every 2 weeks: ITT population - 9 patients at baseline, 2 patients at Month 3, and 7 patients at Final Visit had Plasma GL-3 values"||µg/mL||Standard Deviation|Mean
97291|NCT00837824|Primary|Time to Clinically Significant Progression of Cardiac Disease, Cerebrovascular Disease, and/or Death Among Fabry Patients With Severe Kidney Disease|The trial was terminated early due to inadequate study design. During the study period of 7 months, only 1 patient had a clinical event, a stroke, in the Fabrazyme 1 mg/kg treatment arm. The time to event was determined from first dose of Fabrazyme to the date of event.|7 months|Intent-to-Treat (ITT) Population-consisted of all 20 patients enrolled in the trial. The original sample size was 120 patients. Due to early termination, only 20 patients were enrolled in this trial. No imputation of data was performed. During the 7 months study period, only 1 patient had a clinical event in the Fabrazyme 1 mg/kg treatment arm.||Days|||Number
97292|NCT00837759|Secondary|Change in ZnT8 Autoantibody Titer||6 months following the protocol subject's randomization/treatment initiation|||Titers||Standard Error|Mean
97293|NCT00837759|Secondary|Change in Anti-IA2 Titer||6 months following the protocol subject's randomization/treatment initiation|||Titers||Standard Error|Mean
97294|NCT00837759|Secondary|Change in Anti-GAD Autoantibody Titers||6 months following the protocol subject's randomization/treatment initiation|||Titers||Standard Error|Mean
97295|NCT00837759|Secondary|Change in Insulin Dose||6 months following the protocol subject's randomization/treatment initiation|||U/kg/day||Standard Deviation|Mean
97296|NCT00837759|Secondary|Glycemia Control (Change in HbA1c Level)||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study||Percentage||Standard Deviation|Mean
97297|NCT00837759|Primary|Change in C-peptide||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study||ng/mL||Standard Deviation|Mean
97298|NCT00837616|Secondary|Serum Estrone Sulfate Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||pg/mL||Standard Error|Mean
97299|NCT00837616|Secondary|Serum Estrone Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||pg/mL||Standard Error|Mean
97300|NCT00837616|Primary|Characterize PK/PD and Relative Biological Potency of Different Oral vs TD Estrogen Preparations||6 weeks||||||
97301|NCT00837616|Primary|Change in Fat Free Mass From Baseline at 12 Months||12 months|||kg||Standard Error|Mean
97302|NCT00837616|Primary|Change in Percent Fat Mass From Baseline in 12 Months||12 months|||percent fat mass||Standard Error|Mean
97303|NCT00837616|Primary|Change in Body Mass Index From Baseline at 12 Months||12 months|||kg/m2||Standard Error|Mean
97304|NCT00837616|Secondary|Serum 17B Estradiol Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||pg/ml||Standard Error|Mean
97305|NCT00837616|Secondary|Rates of Lipid Oxidation After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||Kcal/Fat Free Mass/day||Standard Error|Mean
97306|NCT00837616|Secondary|Lipids Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months|||mg/dl||Standard Error|Mean
97307|NCT00837616|Secondary|Changes in Insulin Growth Factor-I From Baseline at 12 Months||12 months|||ng/ml||Standard Error|Mean
97308|NCT00837616|Primary|Change in Weight From Baseline at 12 Months||12 months|||kilograms||Standard Error|Mean
97309|NCT00837577|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.||mg/dL||95% Confidence Interval|Least Squares Mean
97310|NCT00837577|Secondary|Change From Baseline in 2-hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.||mg/dL||95% Confidence Interval|Least Squares Mean
97311|NCT00837577|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
97312|NCT00837512|Primary|Onset Time (Tmax)|Average time to peak insulin concentration|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours|||Minutes||Standard Deviation|Mean
97313|NCT00837486|Other Pre-specified|Therapy-related Adverse Events|Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation.|from enrollment to study closure (average follow-up of 36 months)|All enrolled participants are included in the analysis.||participants|||Number
97314|NCT00837486|Other Pre-specified|Long-term Open-label Responders|This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders.|at the 24-month visit|29 participants started the the Long-Term Follow-up Phase and 24 completed the phase, but all 30 enrolled participants are included in the analysis. Participants that withdrew early are counted as non-responders.||participants|||Number
97315|NCT00837486|Secondary|Quality of Life Change|Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.||change from baseline score||Standard Deviation|Mean
97316|NCT00837486|Secondary|Depression Change|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.||percentage change from baseline||Standard Deviation|Mean
97317|NCT00837486|Primary|Responders|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response.|Baseline to 16 weeks|29 of the 30 subjects are included in this analysis. One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.||participants|||Number
97318|NCT00837447|Primary|Change in Knee Society Knee Score|"change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome.~Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points"|baseline and 3 years|||scores on a scale||Standard Deviation|Mean
97319|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.||percentage of participants|||Number
97320|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.||percentage of participants|||Number
97332|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in picograms of DHT per milliliter of serum.|3 Months|||pg/mL||Standard Deviation|Mean
97321|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.||percentage of participants|||Number
97322|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.||percentage of participants|||Number
97323|NCT00837434|Secondary|"Percentage of Participants Fulfilling DAS-28-CRP Good or Moderate Response Criteria at Week 24"|Good responders had: change in DAS28-CRP (Baseline-Week 24) > 1.2 and the Week 24 DAS-CRP score was <= 3.2. If the conditions for non-response* or good response were not met then the DAS28-CRP response was considered moderate.[*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline –Week 24) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 24) < 1.2 with Week 24 DAS28-CRP score > 5.1 ; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. Participants with measurements for designated time points were included in the analysis.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.||percentage of participants|||Number
97324|NCT00837434|Secondary|Percentage of Participants Fulfilling DAS-28-CRP “Good or Moderate Response” Criteria at Week 12|Good responders: change in DAS28-CRP (Baseline-Week12) > 1.2 and Week 12 DAS-CRP score was <\= 3.2. If the conditions for non-response* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. [*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline –Week 12) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 12) < 1.2 with Week 12 DAS28-CRP score > 5.1; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <\= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point].|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.||percentage of participants|||Number
97325|NCT00837434|Primary|Percentage of CD27+ Switched Memory B Cells at Week 12|Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling.|Week 12|The Per Protocol population includes subjects with a baseline and week 12 (plus or minus 1 week) assessment that received at least 75% of the planned doses of either etanercept or adalimumab prior to week 12 and who did not have any serious protocol deviations.||Percentage of B Cells||Standard Deviation|Mean
97326|NCT00837330|Primary|Commonly Reported and Notable Adverse Events|Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.|2 years|||participants|||Number
97327|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 6 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms.|6 Months|||µg||Standard Deviation|Mean
97328|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 3 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms.|3 Months|||µg||Standard Deviation|Mean
97329|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 6 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in nanograms of testosterone per decaliter of serum.|6 Months|||ng/dL||Standard Deviation|Mean
97330|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 3 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in nanograms of testosterone per decaliter of serum.|3 Months|||ng/dL||Standard Deviation|Mean
97331|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in picograms of DHT per milliliter of serum.|6 Months|Only the 3 patients who were rechallenged with finasteride after Month 3 were included in this analysis.||pg/mL||Standard Deviation|Mean
97333|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 6 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|6 Months|||µL||Standard Deviation|Mean
97334|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 3 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|3 Months|||µL||Standard Deviation|Mean
97335|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months|||µm||Standard Deviation|Mean
97336|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|3 months|||µm||Standard Deviation|Mean
97337|NCT00837252|Secondary|Change in Visual Acuity at Month 6 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months|||ETDRS letters||Standard Deviation|Mean
97338|NCT00837252|Primary|Change in Visual Acuity at Month 3 Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|3 months|||ETDRS letters||Standard Deviation|Mean
97339|NCT00837213|Secondary|Percentage of Particpants With IGA Score at Week 16|"Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment~IGA:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe"|Baseline, Week 16|Subjects who completed week 16||Percent of participants|||Number
97340|NCT00837213|Primary|Change in Investigator Global Assessment (IGA)|"Change in Investigator Global Assessment (IGA) Average values chest and back.~IGA scale:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe"|Baseline, Weeks 4, 8,12, and 16|ITT||Units on a scale||Standard Deviation|Mean
97341|NCT00837213|Secondary|Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12|Percent change in total lesions (chest and back) from baseline to Week 12|Week 12|ITT||Percent change||Standard Deviation|Mean
97342|NCT00837213|Secondary|Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12|Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12|Baseline, Week 12|ITT||Percent change||Standard Deviation|Mean
97343|NCT00837213|Secondary|Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12|Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12|Baseline, Week 12|ITT||Percent Change||Standard Deviation|Mean
97344|NCT00837213|Primary|Percent Change in Total Acne Lesion Counts From Baseline to Week 16|Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)|Baseline, Week 16|ITT||Percent Change||Standard Deviation|Mean
97345|NCT00837213|Primary|Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.|Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.|Baseline, Week 16|ITT||Percent Change||Standard Deviation|Mean
97346|NCT00837213|Primary|Percent Change in Inflammatory Acne Lesions From Baseline to Week 16|Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)|Baseline, Week 16|ITT||Percent change||Standard Deviation|Mean
97347|NCT00837200|Primary|Study Specific Measure (Number of Participants Taken Off Study)||16 weeks|||participants|||Number
97348|NCT00837200|Primary|Study Specific Measure (Response)||16 Weeks|||participants|||Number
97349|NCT00837200|Primary|Tumor Response|"Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU~Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles~MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion~Stable disease > 2mo was a response"|16 weeks|||participants|||Number
97350|NCT00837161|Secondary|Discomfort Level|Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.~Analysed subject numbers were:~from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"||units on a scale||Full Range|Mean
97370|NCT00836875|Secondary|All-Cause Mortality - Number of Participant Deaths|Number of participant deaths reported at Week 6 and at EOT (up to Week 12).|Week 6 and EOT (up to Week 12)|Safety population||participants|||Number
102270|NCT00795951|Primary|Diagnostic Performance: Black Rubber Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
97351|NCT00837161|Secondary|Numerical Range Scale (NRS) of Pain Level|Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.~Analysed subject numbers were:~from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"||units on a scale||Full Range|Mean
97352|NCT00837161|Secondary|Length of Time to Return to Normal Activities|Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)]|per protocol||days||Full Range|Mean
97353|NCT00837161|Secondary|HIFU Treatment Equals Location Per Hysterectomy|Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.|Day 0, Hysterectomy|All participants who underwent hysterectomy following MR-HIFU treatment were included in this endpoint measure. Patients who refused hysterectomy were not included.||participants|||Number
97354|NCT00837161|Primary|Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)|Safety was assessed per protocol; all 11 participants were evaluated for adverse events after HIFU treatment.||treatment-related AE/patient||Full Range|Mean
97355|NCT00837148|Primary|Overall Objective Response|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|at 18 weeks|||participants|||Number
97356|NCT00837031|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months|||months||95% Confidence Interval|Median
97357|NCT00837031|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|18 months|||months||95% Confidence Interval|Median
97358|NCT00837031|Primary|Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment|The percentage of patients who were alive 6 months after beginning treatment|6 months|||percentage of participants||95% Confidence Interval|Number
97359|NCT00836953|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)|Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.|Day 0 and Day 14 Post-dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.||Percentage of Participants|||Number
97360|NCT00836953|Other Pre-specified|Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.|Day 0 and Day 14 after Dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.||Percentage of Participants|||Number
97361|NCT00836953|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination|Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.|Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population||Participants|||Number
97362|NCT00836901|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
97363|NCT00836901|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
97364|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng/mL||Standard Deviation|Mean
97365|NCT00836901|Primary|AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
97366|NCT00836901|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97367|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97368|NCT00836875|Secondary|Time to Death||Baseline up to 1 month post treatment|Safety population; only participants who died were included in the analysis.||days||Full Range|Median
97369|NCT00836875|Secondary|Attributable Mortality - Number of Participant Deaths|Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).|Weeks 6 and EOT (up to Week 12)|Safety population||participants|||Number
97371|NCT00836875|Secondary|Percentage of Participants With a Global Response of Success|Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to <90% resolution of the radiological lesions attributed to IA at Baseline.|Weeks 6 and End of Treatment (EOT; up to Week 12)|Modified intent to treat (MITT) population: all participants receiving at least 1 dose of study drug and diagnosed with proven or probable aspergillosis (defined by modified European Organization for Research and Treatment of Cancer Mycoses Study Group [EORTC/MSC] criteria) or microbiologically confirmed scedosporium or fusarium infection.||percentage of participants||95% Confidence Interval|Number
97372|NCT00836875|Primary|Number of Participants With Adverse Events (AEs)||Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment|Safety population||participants|||Number
97373|NCT00836745|Secondary|Number of Participants Who Required Management of Other Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.||participants|||Number
97374|NCT00836745|Secondary|Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.||participants|||Number
97375|NCT00836745|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)|Per protocol (PP) analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started sunitinib treatment.||percentage of participants||95% Confidence Interval|Number
97376|NCT00836745|Primary|Progression Free Survival (PFS)|PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.|Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)|Data was not analyzed since PFS for all participants was censored either due to inadequate baseline assessments, absence of on-study disease assessment, or being on follow-up for progression.|||||
97377|NCT00836719|Secondary|Change in Brain NAA Level as Measured by MR Spectroscopy|percent change from baseline to exit in NAA levels adjusted for creatine levels|6 months|||percentage change from baseline||95% Confidence Interval|Mean
97378|NCT00836719|Primary|Number of Participants Experiencing Serious Adverse Events||six months|||participants|||Number
97379|NCT00836706|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97380|NCT00836706|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97381|NCT00836706|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97382|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||participants|||Number
97383|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||participants|||Number
97384|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percentage of yes responses||Standard Deviation|Mean
97430|NCT00836355|Primary|Indices of Salvaged Ischemic Penumbra and of Final Infarct Volume Based on Quantitative Volumetric Analyses of Pre- and Post-treatment Perfusion-weighted and Diffusion-weighted Brain MR Imaging||Within approximately 7 days of stroke onset|Although all participants completed the study, none of them had the necessary MRIs performed to gather outcome measure data. The study was closed once it was determined that logistically, it was not possible to complete the study at that point in time.|||||
97385|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percentage of yes responses||Standard Deviation|Mean
97386|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. Were you able to achieve at least some erection (some enlargement of the penis)?  Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percentage of yes responses||Standard Deviation|Mean
97387|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
97388|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
97389|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
97390|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
97391|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
97392|NCT00836693|Secondary|The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint|The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||units on a scale||Standard Deviation|Mean
97393|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary|The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percent||Standard Deviation|Mean
97394|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||percent of volumetric change||Standard Deviation|Mean
97395|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||minutes||Standard Deviation|Mean
97396|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.||Number of events per night||Standard Deviation|Mean
97431|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group||baseline|||Raman spectrocopy intensity counts||Standard Deviation|Mean
97397|NCT00836693|Primary|Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.||percentage of yes responses||Standard Deviation|Mean
97398|NCT00836693|Primary|Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per participant."|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.||percentage of yes responses||Standard Deviation|Mean
97399|NCT00836693|Primary|Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.||units on a scale||Standard Deviation|Mean
97400|NCT00836641|Secondary|Number of Vaccinees With Adverse Events|we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events.|12 months|||participants|||Number
97401|NCT00836641|Primary|Immunogenicity of Pneumococcal Vaccination|we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml).|12 months|we performed a power calculation in advance. To demonstrate a difference wit p<0.05, we would require 30 subjects per arm each. Thus and to allow potential drop-outs, we included 35 subjects per arm.||[µg/ml]||95% Confidence Interval|Geometric Mean
97402|NCT00836498|Secondary|Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3||||||
97403|NCT00836498|Secondary|Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3||||||
97404|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
97405|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
97406|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
97407|NCT00836498|Primary|Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3||||||
97408|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
97409|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
97410|NCT00836498|Primary|Part II: Number of Participants With Serious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 180 days following the third dose of RotaTeq™ and/or placebo||||||
97411|NCT00836498|Primary|Part II: Number of Participants With Nonserious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 42 days following any dose of RotaTeq™ and/or placebo||||||
97432|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma||baseline|||Raman spectroscopy intensity counts||Standard Deviation|Mean
97412|NCT00836498|Primary|Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."||titers||95% Confidence Interval|Geometric Mean
97413|NCT00836498|Primary|Part I: Number of Participants With Serious Adverse Experiences (SAEs)|"All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.~SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose."|Up to 180 days following the third dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience."||participants|||Number
97414|NCT00836498|Primary|Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)|All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.|Up to 42 days following any dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience."||participants|||Number
97415|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97416|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97417|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97418|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97419|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97420|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97421|NCT00836433|Secondary|Change in Facility Fall Rates|Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).|6 months|"This is a facility level analysis of the fall rates in the 4 facilities randomized to FALLS alone compared to the 4 receiving CONNECT + FALLS. Within these groups, medical records from 293 and 358 residents with falls were abstracted to calculate the fall rates, therefore the number of participants analyzed is not the same as the flow module."||change in falls per bed per year|Participants||Number
97422|NCT00836433|Primary|Fall-related Process Measures|The proportion of applicable fall quality indicators documented for residents with falls during the study period. Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.|6 months|Note that the number of participants analyzed is not the same as the number of participants in the flow module. This is because this outcome measure is based not on the consented staff participants in the intervention, but resident charts abstracted in the pre and post intervention periods (waiver of consent obtained).||proportion of indicators completed||Standard Deviation|Mean
97423|NCT00836407|Secondary|To Measure Tumor Marker Kinetics (CA 19-9) in Patients Receiving Treatment.||4 years||||||
97424|NCT00836407|Secondary|To Explore an Association Between Immune-related Adverse Events (IRAEs) and ORR.||4 years||||||
97425|NCT00836407|Secondary|To Estimate Overall Response Rate (ORR), Immune Related Best Overall Response Rate (irBOR), Progression Free Survival (PFS), and Duration of Response in Patients Receiving Treatment.||4 years||||||
97426|NCT00836407|Secondary|Overall Survival (OS)||4 years|||Months||95% Confidence Interval|Median
97427|NCT00836407|Primary|Determine if Ipilimumab Alone or in Combination With Pancreatic Tumor Vaccine Has an Acceptable Safety Profile (Less Than 33% Unacceptable Toxicity) in Subjects With Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma|Unnacceptable toxicities are defined as drug related > grade 4 AEs or grade 3 AE including IRAEs not improving to < grade 2 under therapy within 2 weeks. In addition, > grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to < grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.|4 years|||Percent|||Number
97428|NCT00836355|Secondary|Modified Rankin Scale Score||Baseline, and approximately one week and 3 months later|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.|||||
97429|NCT00836355|Secondary|NIH Stroke Scale Scores||Baseline and after approximately one week|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.|||||
97433|NCT00836342|Primary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects|Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.|baseline|Participants that passed inclusion criteria and consented for skin carotenoid measurement were analyzed.||Raman spectroscopy intensity counts||Standard Deviation|Mean
97434|NCT00836277|Secondary|1-year (Overall) Survival Rate||1 year|||percentage of participants|||Number
97435|NCT00836277|Secondary|Overall Survival (OS)||Up to 45 months (cohort)|||months||95% Confidence Interval|Median
97436|NCT00836277|Secondary|Progression-free Survival (PFS)|Survival time the is free of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 45 months (cohort)|||months||95% Confidence Interval|Median
97437|NCT00836277|Primary|Clinical Benefit Rate (CBR)|Using RECIST v1.0 criteria, clinical benefit rate (CBR) = # participants with (PR) + # participants with (CR) + # participants with (SD) / # participants with (PR) + # participants with (CR) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions is defined as: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 14 months|||percentage of participants||95% Confidence Interval|Number
97438|NCT00836277|Primary|Response Rate (RR)|Response rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|Up to 14 months|||percentage of participants||95% Confidence Interval|Number
97439|NCT00836095|Secondary|Insertion Success Rate|Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.|During intubation of the patient|||Number of successful airway insertions|||Number
97440|NCT00836095|Primary|Insertion Time|The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.|During intubation of the patient|||seconds||Standard Deviation|Mean
97441|NCT00836056|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97442|NCT00836056|Primary|Bioequivalence Based on AUCinf|AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97443|NCT00836056|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97444|NCT00836017|Secondary|Pain Numeric Rating Scale Score|Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.||score on a scale||Standard Deviation|Mean
97445|NCT00836017|Secondary|Percentage of Participants With Improvement in the Patient Global Impression of Change|The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.||percentage of participants|||Number
97446|NCT00836017|Secondary|Percentage of Participants With Improvement in Clinicians Global Impression of Change|The physician evaluated the change in the patient’s present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.||percentage of participants|||Number
97447|NCT00836017|Secondary|Percentage of Participants With Cervical Dystonia (CD) Severity Mild|The physician assessed the patient’s severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.||percentage of participants|||Number
97448|NCT00836017|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.||score on a scale||Standard Deviation|Mean
97449|NCT00836004|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97450|NCT00836004|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97451|NCT00836004|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97452|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97453|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97454|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97455|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97456|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97457|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97458|NCT00835978|Secondary|PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented.|Baseline, C1D1|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.||Months||95% Confidence Interval|Median
97459|NCT00835978|Secondary|ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms.|Baseline, C1D1|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.||Percentage of participants||95% Confidence Interval|Number
97460|NCT00835978|Secondary|Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|C1D1, C1D15, C2D15, EOT|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Ratio||Standard Deviation|Mean
97461|NCT00835978|Secondary|Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|Baseline|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
97462|NCT00835978|Secondary|Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|Cycle 1 Day 1 (C1D1), C1D15, C2D15, End of therapy (EOT)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Ratio||Standard Deviation|Mean
97463|NCT00835978|Secondary|Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|Baseline|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
97464|NCT00835978|Secondary|Change From Baseline in Diastolic Blood Pressure|Value at respective visit minus value at baseline.|Baseline up to follow-up visit|The SA population consists of all participatns who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
97465|NCT00835978|Secondary|Change From Baseline in Systolic Blood Pressure|Value at respective visit minus value at baseline|Baseline up to follow-up visit|The SA population consists of all participatns who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
97466|NCT00835978|Secondary|Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||L||95% Confidence Interval|Geometric Mean
97467|NCT00835978|Secondary|Apparent Oral Clearance (CL/F) of Axitinib|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||L/hr||95% Confidence Interval|Geometric Mean
97468|NCT00835978|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||hr||Standard Deviation|Mean
97469|NCT00835978|Secondary|Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib|Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng.hr/mL||95% Confidence Interval|Geometric Mean
97470|NCT00835978|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng.hr/mL||95% Confidence Interval|Geometric Mean
97471|NCT00835978|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,|Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||hrs||Full Range|Median
97472|NCT00835978|Secondary|Maximum Observed Plasma Concentration (Cmax) of Axitinib|Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.||ng/mL||95% Confidence Interval|Geometric Mean
97473|NCT00835978|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive.|Baseline up to at least one year after the last patient has been randomized.||01/2018||||
97474|NCT00835978|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks|The responders population included all participants who achieved an objective response.||Months||95% Confidence Interval|Median
97475|NCT00835978|Secondary|Progression-Free Survival (PFS) - All Participants|The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks|The SA population consists of all participants who received at least one dose of study medication.||Months||95% Confidence Interval|Median
97493|NCT00835796|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97494|NCT00835796|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97495|NCT00835731|Secondary|Women's Preferences for Cervical Ripening Method||5 hours after placement of ripening agent||||||
97476|NCT00835978|Secondary|Progression-Free Survival (PFS)|The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks|The Full Analysis (FA) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
97477|NCT00835978|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response (All Participants)|ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline up to disease progression, death, or withdrawal with minimum follow-up of 12 months; assessments performed at baseline and repeated every 8 weeks.|The SA population consists of all participants who received at least one dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
97478|NCT00835978|Primary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline up to disease progression, death, or withdrawal with minimum follow-up of 12 months; assessments performed at baseline and repeated every 8 weeks.|The Full Analysis (FA) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
97479|NCT00835926|Primary|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay|Day 21 Post-vaccination|The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
97480|NCT00835926|Primary|Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 21 Post-vaccination|The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population.||Percentage of Participants|||Number
97481|NCT00835926|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 21 Post-vaccination|The Geometric mean titers were analyzed in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
97482|NCT00835926|Primary|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®|"Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.~Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia"|Days 0 to 3 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
97483|NCT00835861|Secondary|Number of Babies With Adverse Neonatal Outcomes|Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.|Delivery until hospital discharge|"For 1 infant in the metformin group, the adverse neonatal outcome data was missing."||number of babies|||Number
97484|NCT00835861|Secondary|Number of Episodes Maternal Hypoglycemia|Maternal glucose < 60 mg/dL|Baseline throughout pregnancy until time of delivery|||Number of episodes|||Number
97485|NCT00835861|Secondary|Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)|NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130|Baseline throughout pregnancy until time of delivery|||percent of glucose values|||Number
97486|NCT00835861|Secondary|Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)|NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95|Baseline throughout pregnancy until time of delivery|||percent of glucose values|||Number
97487|NCT00835861|Secondary|Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester||1st, 2nd, and 3rd trimester|||percentage of glycosolated hemoglobin||Inter-Quartile Range|Median
97488|NCT00835861|Secondary|Number of Babies With Neonatal Hypoglycemia|Initial neonatal glucose < 40 mg/dL|Time of delivery through hospital discharge|For 1 infant in each group, the initial neonatal glucose value was missing.||Number of babies|||Number
97489|NCT00835861|Secondary|Maternal Weight Gain||Baseline throughout pregnancy until last prenatal visit.|||kg/week||Inter-Quartile Range|Median
97490|NCT00835861|Secondary|Number of Patients With Obstetric Complications|Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.|Throughout pregnancy until hospital discharge following delivery.|||participants|||Number
97491|NCT00835861|Primary|Blood Glucose Measurements|Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.|Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery|For 1 infant in each group, the initial neonatal glucose value was missing.||mg/dL||Inter-Quartile Range|Median
97492|NCT00835796|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97496|NCT00835731|Secondary|Subject Pain During Dilation and Evacuation|"Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:~0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain~Higher values represent a worse outcome."|3-4 hours after placement of ripening agent|||Scores on a scale||Inter-Quartile Range|Median
97497|NCT00835731|Secondary|Subject Pain During Ripening|"Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:~0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain~Higher values represent a worse outcome."|3-4 hours after placement of ripening agent|||Scores on a scale||Inter-Quartile Range|Median
97498|NCT00835731|Secondary|Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt||3-4 hours after placement of ripening agent|||participants|||Number
97499|NCT00835731|Secondary|Procedure Time for Dilation and Evacuation||3-4 hours after placement of ripening agent|||minutes||Inter-Quartile Range|Median
97500|NCT00835731|Secondary|Ease of Further Mechanical Dilation||3-4 hours after placement of ripening agent||||||
97501|NCT00835731|Primary|Cervical Dilation in Women Following Exposure to Either Ripening Agent||3-4 hours after placement of ripening agent|||mm||Standard Deviation|Mean
97502|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97503|NCT00835705|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97504|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97505|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97506|NCT00835705|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97507|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97508|NCT00835692|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97509|NCT00835692|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97510|NCT00835692|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97511|NCT00835679|Secondary|Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration||From day 15 (day of surgery) to 30 days after surgery|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers.No patients received any study drugs. This study was closed prematurely due to slow accrual.|||||
97512|NCT00835679|Secondary|Number of Patients With the Given Severity of Adverse Event Within a Specified Duration|Number of patients with each grade of adverse event (AE) during the specified timeframe using the Common Terminology Criteria for AEs guide, grades 1-5 with one being mild, five is death.|weekly to day 15, and at followup on day 30|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No patients were accrued to Cohorts B, C, D. This study was closed prematurely due to slow accrual.|||||
97513|NCT00835679|Secondary|Patients With Reduction of Biomarkers in Tumor Tissue|Patients with pre-to-post treatment reduction at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker: total & phi-EGFR, phi-MAPK, phi-Akt, Ki67, phi-FAK, phi-paxillin, phi-Src, capase 3. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for biomarker in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%)|study entry to day 15|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.|||||
97514|NCT00835679|Primary|Patients With a Biologic Response|Patients who experienced a pre-to-post treatment reduction of at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker of the pathway being inhibited: epidermal growth factor (EGFR) for Cohort B, sarcoma (Src) for Cohort C, and both EGFR and Src for Cohort D. Blood for these biomarkers will be taken on day of baseline and pre-operatively on day 15. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for pathway in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%).|on baseline and preoperatively on day of surgery (day 15)|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.|||||
97515|NCT00835666|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97516|NCT00835666|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97517|NCT00835666|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97518|NCT00835640|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97519|NCT00835640|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97520|NCT00835640|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97521|NCT00835614|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97522|NCT00835614|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97523|NCT00835614|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97524|NCT00835588|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97525|NCT00835588|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all subjects data could be used to estimate AUC0-inf.||ng*h/mL||Standard Deviation|Mean
97526|NCT00835588|Primary|Cmax - Maximum Observed Concentration - Pantoprazole in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97527|NCT00835575|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
97528|NCT00835575|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
97529|NCT00835575|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
97530|NCT00835549|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97531|NCT00835549|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97532|NCT00835549|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97533|NCT00835536|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97534|NCT00835536|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97535|NCT00835510|Primary|Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra|Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).|42 days|Patients with negative cultures excluded. Use per protocol population||Participants|||Number
97536|NCT00835510|Secondary|Safety and Adverse Event Profile||42 days||||||
97537|NCT00835510|Secondary|Clinical Cure|"The following 8 signs and symptoms are rated at each visit:~Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning~Each symptom is evaluated using the following scale:~0 = None- Complete absence of any sign or symptom~= Mild – obvious but minimal involvement~= Moderate – something that is easily noted~= Severe – quite marked~Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2."|42 days|ITT population||Participants|||Number
97538|NCT00835510|Secondary|Mycologic Cure|Negative KOH and fungal culture at day 42|42 days|ITT population||Participants|||Number
97539|NCT00835510|Secondary|Therapeutic Cure|Subject with clinical and mycological cure at day 7|7 days|ITT Population||Participants|||Number
97593|NCT00835185|Secondary|Change From Baseline in Tumor Size||Baseline, 29 Months|Zero participants were analyzed, the outcome measure was registered in error.|||||
97540|NCT00835510|Primary|Therapeutic Cure - Superiority Analysis|"Therapeutic Cure requires both Clinical Cure and Mycological Cure.~Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure.~Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative."|42 days|Patients with negative cultures at baseline are excluded. Efficacy ITT analysis includes all patients with positive baseline cultures, who received at least one dose of medication, had a follow-up visit and had data for the day 42 visit.||Participants|||Number
97541|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]- Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97542|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97543|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97544|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97545|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]- Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97546|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97547|NCT00835484|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97548|NCT00835484|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97549|NCT00835484|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97550|NCT00835406|Primary|Bioequivalence Based on Ae0-36|Ae0-36 = cumulative urine excretion|Urine collected over 36 hour period|||ng/mL||Standard Deviation|Geometric Mean
97551|NCT00835406|Primary|Bioequivalence Based on Rmax|Rmax = maximum rate of urinary excretion|Urine collected over 36 hour period|||ng/mL||Standard Deviation|Geometric Mean
97552|NCT00835380|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject’s temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all subjects who were vaccinated at least one dose and had safety follow-up data||participants|||Number
97553|NCT00835380|Primary|Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.|"Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines.~HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL."|Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)|Per-protocol population, defined as all HAV-susceptible subjects who completed the vaccination regimen within acceptable day ranges, had 2 valid serology results on Day 0 and Month 7, and met all inclusion/exclusion criteria.||Percentage of Participants|||Number
97554|NCT00835367|Secondary|AUC0-t - Benazeprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97555|NCT00835367|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97556|NCT00835367|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97594|NCT00835185|Secondary|Vss at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Vss results were not collected.|||||
97557|NCT00835367|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97558|NCT00835367|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97559|NCT00835367|Primary|Cmax - Benazepril|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97560|NCT00835367|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
97561|NCT00835367|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
97562|NCT00835367|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg/mL||Standard Deviation|Mean
97563|NCT00835354|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97564|NCT00835354|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97565|NCT00835354|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97566|NCT00835341|Secondary|Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia||from 3 months to 124 months||||||
97567|NCT00835341|Primary|The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia|The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.|from 3 months to 124 months|||participants|||Number
97568|NCT00835276|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97569|NCT00835276|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97570|NCT00835276|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97571|NCT00835263|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97572|NCT00835263|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97573|NCT00835263|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97574|NCT00835237|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the vaccintation up to Day 182|||subjects|||Number
97575|NCT00835237|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration|Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
97576|NCT00835237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period|||subjects|||Number
97577|NCT00835237|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results||subjects|||Number
97595|NCT00835185|Secondary|CL at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, CL results were not collected.|||||
97578|NCT00835237|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results||subjects|||Number
97579|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.|"Vaccine response defined as:~For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination.~For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
97580|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off|"Booster response defined as :~For initially seronegative subjects (< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination.~For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
97581|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off|"Booster response defined as :~For initially seronegative subjects (< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination.~For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
97582|NCT00835237|Secondary|Anti-T and Anti-D Antibody Concentrations|Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||IU/mL||95% Confidence Interval|Geometric Mean
97583|NCT00835237|Primary|Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value|"Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T).~Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL)~Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL"|One month after vaccination.|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
97584|NCT00835224|Primary|Blood Pressure||Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration|||mmHg||Standard Deviation|Mean
97585|NCT00835211|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg*h/mL||Standard Deviation|Mean
97586|NCT00835211|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 12 hour period|AUC0-inf could not be estimated for one subject in the reference arm.||pg*h/mL||Standard Deviation|Mean
97587|NCT00835211|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||pg/mL||Standard Deviation|Mean
97588|NCT00835198|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of lesions||Standard Deviation|Mean
97589|NCT00835198|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
97590|NCT00835198|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
97591|NCT00835198|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12|Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of Lesions||Standard Deviation|Mean
97592|NCT00835185|Secondary|Kirsten Rat Sarcoma (KRAS) Mutation Status|Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis.|Baseline|All enrolled participants who had assessment of tumor tissue samples at baseline.||participants|||Number
97599|NCT00835185|Secondary|Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate Vss.||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
97600|NCT00835185|Secondary|Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1|CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate CL.||milliliters/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
97601|NCT00835185|Secondary|Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1|The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate t1/2.||hours (h)||Full Range|Geometric Mean
97602|NCT00835185|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate AUC(0-∞).||micrograms*hour/milliliter (µg*h/mL)]||Geometric Coefficient of Variation|Geometric Mean
97603|NCT00835185|Secondary|Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had pharmacokinetic (PK) data available to calculate Cmax.||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
97604|NCT00835185|Secondary|Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.|Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)|All participants who received any amount of study drug and were IMC-11F8 antibody negative at baseline.||participants|||Number
97605|NCT00835185|Secondary|Duration of Response|The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.|Time of response to time of measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug and had confirmed CR or PR. Participants censored =2.||months||95% Confidence Interval|Median
97606|NCT00835185|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death|The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to end of treatment and 30-day post treatment follow-up up to 31 months|All enrolled participants who received any quantity of study drug.||participants|||Number
97607|NCT00835185|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period.|First dose to measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =13.||months||95% Confidence Interval|Median
97608|NCT00835185|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact.|First dose to date of death from any cause up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =14.||months||95% Confidence Interval|Median
97609|NCT00835185|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )|CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100.|Up to 30 Months|All enrolled participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
97610|NCT00835172|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97611|NCT00835172|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for three subjects.||ng*h/mL||Standard Deviation|Mean
97614|NCT00835146|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97615|NCT00835146|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97616|NCT00835120|Secondary|Change in Clinical Global Impressions-Bipolar Version (CGI-BP)|The CGI-BP asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.|Week 0 - Week 8|||units on a scale||Standard Error|Least Squares Mean
97617|NCT00835120|Secondary|Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores|A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.|Week 0 - Week 8|||participants|||Number
97618|NCT00835120|Secondary|Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)|A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.|Week 0 - Week 8|||participants|||Number
97619|NCT00835120|Secondary|Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score|The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome|Week 0 - Week 8|||units on a scale||Standard Error|Least Squares Mean
97620|NCT00835120|Primary|Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 8|||units on a scale||Standard Error|Least Squares Mean
97621|NCT00835081|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97622|NCT00835081|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97623|NCT00835081|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97624|NCT00835068|Secondary|Subjective Assessment of Ease of Use by Participant|Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.||participants|||Number
97625|NCT00835068|Secondary|Subjective Assessment of Efficacy by Physician|Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.||participants|||Number
97626|NCT00835068|Secondary|Dose Per Injection of BeneFIX|Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, ‘n’ signifies participants evaluable for this measure during the specified treatment period.||IU/kg||Standard Deviation|Mean
97627|NCT00835068|Secondary|Subjective Assessment of Efficacy by Participant|Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.||participants|||Number
97628|NCT00835068|Secondary|Total Consumption of BeneFIX|Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX. Participants with at least one follow-up visit were evaluable for this outcome measure.||International Unit (IU)||Standard Deviation|Mean
97629|NCT00835068|Secondary|Number of Bleeding Episodes Requiring Treatment by Injection|Number of injections (1, 2, 3 or greater than or equal to [>= 4]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'number of bleeding episodes analyzed' signifies episodes evaluable for this measure. ‘n’ signifies those bleeding episodes with injection data available during specified period.||bleeding episodes|Participants||Number
97652|NCT00834990|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
97630|NCT00835068|Secondary|Number of Bleeding Episodes|Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, ‘n’ signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population: participants with basal FIX activity less than or equal to (<=) 1 percent (%) with real exposure days in diary at least 70% of planned exposure days for prophylaxis period, and without FIX inhibitor before or during study (no FIX inhibitor history at baseline; FIX inhibitor titer <0.6 Bethesda Unit [BU] during follow up).||bleeding episodes|||Number
97631|NCT00835068|Primary|Number of Participants With Events of Special Interest|Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX.||participants|||Number
97632|NCT00835068|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.|Year 3.5 up to 4.75|Safety population included all participants who received at least one dose of BeneFIX. Previously untreated participants were not evaluable for this outcome measure due to discontinuation prior to safety amendment.||participants|||Number
97633|NCT00835068|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.|Baseline up to Year 3.5|Safety population included all participants who received at least one dose of BeneFIX.||participants|||Number
97634|NCT00835042|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97635|NCT00835042|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97636|NCT00835042|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97637|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97638|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97639|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97640|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97641|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97642|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97643|NCT00835003|Secondary|Pediatric Admission and Morbidity||From birth until 2 years of age||||||
97644|NCT00835003|Secondary|Pediatric Admission and Morbidity||2 months post partum||||||
97645|NCT00835003|Secondary|Post Partum Depression||2 months||||||
97646|NCT00835003|Secondary|Maternal Satisfaction With Timing of Elective Caesarean Section||2 months||||||
97647|NCT00835003|Secondary|Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission||30 days||||||
97648|NCT00835003|Secondary|Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.||30 days||||||
97649|NCT00835003|Secondary|Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics||30 days||||||
97653|NCT00834990|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
97654|NCT00834990|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg/mL||Standard Deviation|Mean
97655|NCT00834977|Secondary|AUC0-t - Benazaprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97656|NCT00834977|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
97657|NCT00834977|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis||ng*h/mL||Standard Deviation|Mean
97658|NCT00834977|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97659|NCT00834977|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97660|NCT00834977|Primary|Cmax - Benazepril|Bioequvialence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97661|NCT00834977|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
97662|NCT00834977|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg*h/mL||Standard Deviation|Mean
97663|NCT00834977|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.||pg/mL||Standard Deviation|Mean
97664|NCT00834964|Secondary|AUC0-t - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
97665|NCT00834964|Secondary|AUC0-inf - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
97666|NCT00834964|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng/mL||Standard Deviation|Mean
97667|NCT00834964|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
97668|NCT00834964|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng*h/mL||Standard Deviation|Mean
97669|NCT00834964|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.||ng/mL||Standard Deviation|Mean
97670|NCT00834912|Secondary|t1/2|Apparent terminal elimination half-life (t1/2)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variable T1/2 of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.||hours||Standard Deviation|Mean
97671|NCT00834912|Secondary|Tmax|Time to maximum plasma concentration (Tmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.||hours||Full Range|Median
97672|NCT00834912|Primary|Cmax|Maximum plasma concentration (Cmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.||ng/mL||Standard Deviation|Mean
97673|NCT00834912|Primary|AUC(0-∞)|"The area under the plasma concentration (AUC) curve was estimated by extrapolating to infinity AUC0–t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R’2 (coefficient of determination). The units are ng.h/mL.~h=hours"|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variables AUC(0-∞) of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.||ng.h/mL||Standard Deviation|Mean
97674|NCT00834912|Primary|AUC(0-t)|Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.||ng.h/mL||Standard Deviation|Mean
97675|NCT00834899|Primary|Change in Platelet Count|Change in platelet counts occurring anytime from randomization up to day 35 (final follow-up visit).|Up to 35 days|||x 10^9/L||Full Range|Median
97676|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Hospitalization|The duration of hospitalization will be defined as the period from randomization to the time an order for discharge from the hospital is written.|Up to 7 days|Intention to treat||Days||Full Range|Median
97677|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Acute Pain Episodes|"The duration of the pain episode will be defined as the time from randomization to termination of the pain episode. The pain episode will be considered terminated when the patient states that the crisis is resolved (defined as being ready to go home on oral analgesics) or all of the following criteria are met:~Pain relief (pain scores ≤ 40) maintained for at least 2 consecutive readings (assessed using a visual analog scale with measurements from 0 - 100, where 0 is no pain and 100 is worst imaginable pain).~No parenteral analgesics have been administered for at least 12 hours.~Ability to walk normally (unless he/she was unable to walk for some other reason prior to the crisis onset)."|Up to 7 days|Intention to treat||Days||Full Range|Median
97678|NCT00834899|Primary|1) Major Bleeding Episodes|Major bleeding episodes are defined as any episode, such as gastrointestinal bleeding or intracranial bleed that typically leads to hospitalization or other prolonged bleeding requiring a blood transfusion|Up to 35 days|Intention to treat||participants|||Number
97679|NCT00834886|Primary|To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|Actigraphy, sleep onset latency (SOL). An actigraph is a wrist-worn movement sensor that objectively record motor activity. Participants used an event button to mark bed time and rise time. The actiwatch is waterproof and participants were instructed not to take it off at any time during the data collection peroid.|1 day after 2-week treatment ended|||Minutes||Standard Deviation|Mean
97680|NCT00834886|Primary|To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 (very alert) to 9 (very sleepy, fighting sleep, effort to stay awake)."|1 day after 2-week treatment ended|All participants in the four arms||units on a scale||Standard Deviation|Mean
97681|NCT00834886|Primary|To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Sleep diary, rise time (when participants rise from bed in the morning, self-report) before and after a randomized controlled 4 armed treatment study including a follow-up 3 months later.~Midnight is 0000; in the outcome measure table the value is given in minutes after midnight.~i.e. 530 equals 08:50 in the morning."|1 day after two-week treatment ends|||Minutes||Standard Deviation|Mean
97682|NCT00834873|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97683|NCT00834873|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97684|NCT00834873|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97685|NCT00834808|Secondary|t1/2|Apparent terminal elimination half-life|48 hours|||hours||Standard Deviation|Mean
97686|NCT00834808|Secondary|Tmax|Time to maximum plasma concentration|48 hours|||hours||Full Range|Median
97687|NCT00834808|Primary|Cmax|Maximum plasma concentration.|48 hours|||ng/mL||Standard Deviation|Mean
97688|NCT00834808|Primary|AUC(0-inf)|Area under the plasma concentration versus time curve extrapolated to infinity. h = hours|48 hours|||ng.h/mL||Standard Deviation|Mean
97689|NCT00834808|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measurable concentration.~h = hours"|48 hours|||ng.h/mL||Standard Deviation|Mean
97690|NCT00834795|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97691|NCT00834795|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97692|NCT00834795|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97693|NCT00833794|Secondary|Discontinuation Due to Adverse Events|The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
97694|NCT00833794|Secondary|Discontinuation Due to Lack of Efficacy|The number of patients who discontinued due to lack of efficacy was reported.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
97695|NCT00833794|Secondary|Time to Response|Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||days||95% Confidence Interval|Median
97696|NCT00833794|Secondary|Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|week 12|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
97697|NCT00833794|Secondary|Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||participants|||Number
97698|NCT00833794|Secondary|WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
97699|NCT00833794|Secondary|WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
97700|NCT00833794|Secondary|Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)|Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
97701|NCT00833794|Secondary|Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain|6 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
97702|NCT00833794|Primary|Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.||Points on a scale||Standard Deviation|Mean
97703|NCT00833781|Secondary|IL2 and IFN Gamma Production||Baseline to week 14|Results from these assays were too variable to be interpretable.|||||
97704|NCT00833781|Primary|Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef|Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline.|Baseline and 14 weeks|||fold ratio||Full Range|Median
97705|NCT00833781|Secondary|T Cell Proliferation||Baseline to week 14|||fold change||95% Confidence Interval|Mean
97706|NCT00833781|Primary|Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)|Number of participants with grade 3 or 4 adverse events related to vaccination|After vaccination|||participants|||Number
97707|NCT00833755|Primary|Change in Duration of Supra-threshold Pain Tolerance|"Using QST, we detected the duration (seconds) of tolerance to supra-threshold heat pain stimulation. In this test, subjects were asked to tolerate, as long as he or she could, heat stimulation preset at 47°C for a maximum of 60 seconds. They were given the computer mouse to stop the test if they reached their limit before 60 seconds. If they stopped the test before the 60 seconds, the time that they stopped it was recorded.~This test was repeated 3 times and an average duration was calculated. The duration could range from a minimum of 0 seconds to a maximum of 60 seconds."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.||seconds||Standard Deviation|Mean
97708|NCT00833755|Primary|Change in Temperature of Pain Tolerance|"Using QST, we measured the change in pain tolerance which was the maximum thermal stimulation intensity (in °C) tolerable. In this test, the subject was instructed to press the computer mouse to stop stimulation when the thermode reached the maximal tolerable temperature.~This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.||Degrees Celsius||Standard Deviation|Mean
97735|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97736|NCT00833690|Secondary|Serum Urate|From blood sample drawn before taking study drug that day|Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97737|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97709|NCT00833755|Primary|Change in Temperature of Pain Threshold|"We measured the change in pain threshold using Quantitative Sensory Testing (QST). QST refers to a set of quantitative testing of individual responses to mechanical, thermal, and/or electrical stimulation. In this study, pain threshold was the thermal stimulation intensity (in°C) first perceived as painful. To measure this, a contact thermode was attached onto the dorsal surface of the forearm. By pressing a computer mouse button, each subject was able to stop stimulation when they first perceived a painful stimulation from the thermode as the temperature increased 1°C/s.~This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.||Degrees Celsius||Standard Deviation|Mean
97710|NCT00833703|Primary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.|Up to a maximum of 6 months|The analysis was performed on the same population as previously (i.e. ITT population).||participants|||Number
97711|NCT00833703|Secondary|Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths|"Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.~Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first)."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.||participants|||Number
97712|NCT00833703|Primary|Number of Participants With Bleeding Events|"All bleeding events experienced during the study period were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.||participants|||Number
97713|NCT00833690|Secondary|Change in Serum Urate|Change from Last Visit on Study Drug|Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days)|||mg/dL||Standard Deviation|Mean
97714|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit])|||mg/dL||Standard Deviation|Mean
97715|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 12 from Baseline (i.e., between -45 days and +24 months)|||mg/dL||Standard Deviation|Mean
97716|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 11 from Baseline (i.e., between -45 days and +21 months)|||mg/dL||Standard Deviation|Mean
97717|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 10 from Baseline (i.e., between -45 days and +18 months)|||mg/dL||Standard Deviation|Mean
97718|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 09 from Baseline (i.e., between -45 days and +15 months)|||mg/dL||Standard Deviation|Mean
97719|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 08 from Baseline (i.e., between -45 days and +12 months)|||mg/dL||Standard Deviation|Mean
97720|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 07 from Baseline (i.e., between -45 days and +9 months)|||mg/dL||Standard Deviation|Mean
97721|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 06 from Baseline (i.e., between -45 days and +6 months)|||mg/dL||Standard Deviation|Mean
97722|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 05 from Baseline (i.e., between -45 days and +12 weeks)|||mg/dL||Standard Deviation|Mean
97723|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 04 from Baseline (i.e., between -45 days and +9 weeks)|||mg/dL||Standard Deviation|Mean
97724|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 03 from Baseline (i.e., between -45 days and +6 weeks)|||mg/dL||Standard Deviation|Mean
97725|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 02 from Baseline (i.e., between -45 days and +4 weeks)|||mg/dL||Standard Deviation|Mean
97726|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 01 from Baseline (i.e., between -45 days and +2 weeks)|||mg/dL||Standard Deviation|Mean
97727|NCT00833690|Secondary|Serum Urate|From blood sample drawn a month after stopping study drug|Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 Visit|||mg/dL||Standard Deviation|Mean
97728|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97729|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97730|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97731|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97732|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97733|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97734|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit)|||mg/dL||Standard Deviation|Mean
97743|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Screening Visits, up to 45 days prior to Baseline Visit. Specifically, Screening Visit 1 occurred between day -45 and -4; Screening Visit 2 occurred between day -43 and -2.|||mg/dL||Standard Deviation|Mean
97744|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Males)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks|||percentage of baseline serum urate||Standard Deviation|Mean
97745|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Females)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks|||percentage of baseline serum urate||Standard Deviation|Mean
97746|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (All Patients)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks|||percentage of baseline serum urate||Standard Deviation|Mean
97747|NCT00833690|Secondary|CSF Urate (Males)||12 weeks|||mcg/dL||Standard Deviation|Mean
97748|NCT00833690|Secondary|CSF Urate (Females)||12 weeks|||mcg/dL||Standard Deviation|Mean
97749|NCT00833690|Secondary|CSF Urate (All Patients)|Urate concentration in cerebrospinal fluid (CSF)|12 weeks|||mcg/dL||Standard Deviation|Mean
97750|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to AEs, and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|24 months|||percentage of participants|||Number
97751|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to adverse experiences (AEs), and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|6 months|||percentage of participants|||Number
97752|NCT00833664|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97753|NCT00833664|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97754|NCT00833664|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97755|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who received tadalafil 2.5 mg in the double-blind study period and did not respond to treatment in that treatment period, who have at least 1 baseline observation and who took at least 1 dose of tadalafil 5 mg in the open-label period followed by at least 1 intercourse attempt.||percentage successful attempts||Standard Deviation|Mean
97756|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation, who took tadalafil 5 mg during the double-blind treatment period, and who took at least 1 dose of tadalafil 5 mg followed by at least 1 intercourse attempt during the open-label period.||percentage successful attempts||Standard Deviation|Mean
97776|NCT00834756|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration (Per Participant) - Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97757|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage successful attempts||Standard Deviation|Mean
97758|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage successful attempts||Standard Deviation|Mean
97759|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts|"Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? Data are presented as the proportion of intercourse attempts for which participants answered yes relative to the total number of intercourse attempts. Total number of attempts = TNA."|14 days during double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of total number of attempts|||Number
97760|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses|"Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a yes response to the sexual encounter profile diary question 3: Did your erection last long enough for you to have successful intercourse? Data are based on participants who responded yes. For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy."|4 days double-blind period|Included in the analysis were all subjects with successful intercourse within the first 4 days of treatment, who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||days||Standard Error|Median
97761|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 5: Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
97762|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 4: Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
97763|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 3: Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
97764|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 2: Were you able insert your penis into your partner's vagina? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
97765|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 1: Were you able to achieve at least some erection (some enlargement of the penis)? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||percentage of participants||Standard Error|Least Squares Mean
97766|NCT00833638|Primary|Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3|Cumulative percentage of participants achieving successful intercourse, as measured by “yes” responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse.|4 days during double-blind period|Modified intent-to-treat population consisting of all participants who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.||cumulative percentage of participants|||Number
97767|NCT00833586|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97768|NCT00833586|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97769|NCT00833586|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97770|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.|Up to Day 63|"Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."||Percentage of participants|||Number
97771|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible|Up to Day 63|"Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."||Percentage of participants|||Number
97772|NCT00833560|Secondary|Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations.||Participants|||Number
97773|NCT00833560|Primary|Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).||Participants|||Number
97774|NCT00833547|Primary|Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography|2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)|during two nights in an inpatient Clinical Research Center|||spindles per minute during Stage 2 sleep||Standard Deviation|Mean
97775|NCT00833547|Primary|Overnight Change on Finger Tapping Task|"The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) as quickly and accurately as possible for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning."|Train on Day 3 and Test on Day 4 of study (experimental nights)|||percent change||Standard Deviation|Mean
97853|NCT00834275|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97777|NCT00834756|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97778|NCT00834756|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97779|NCT00834743|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
97780|NCT00834743|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97781|NCT00834743|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97782|NCT00834717|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Bl;ood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97783|NCT00834717|Primary|Auc0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97784|NCT00834717|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97785|NCT00834678|Primary|Progression-free Survival at 6 Months and 12 Months (Phase II)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to two years|||months||95% Confidence Interval|Mean
97786|NCT00834678|Secondary|Relationship of EGFR Expression or Amplification, Basal-like Tumors, and DNA Damage-repair Checkpoint Activation With ORR, CBR, DR, and OS||up to two years|Correlative studies to assess EGFR expression and gene amplification, were planned, but not performed because of early trial termination.|||||
97787|NCT00834678|Secondary|Overall Survival (OS) Rate||from time of study enrollment until death, for up to 2 years|||months||95% Confidence Interval|Median
97788|NCT00834678|Secondary|Duration of Response (DR)||Up to two years|||months to progression||95% Confidence Interval|Median
97789|NCT00834678|Secondary|Clinical Benefit Rate (CBR)||Up to two years||||||
97790|NCT00834678|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to two years|||patients|||Number
97791|NCT00834678|Primary|Dose-limiting Toxicity (Phase I)||Up to two years|||patients|||Number
97792|NCT00834678|Primary|Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)|28 day cycle included intravenous erlotinib on days 15-21.|Up to two years|||mg|||Number
97793|NCT00834678|Primary|Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)|28 day cycle included intravenous bendamustine on days 1 and 2.|Up to two years|||mg/m^2|||Number
97794|NCT00834639|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
97795|NCT00834639|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg*h/mL||Standard Deviation|Mean
97796|NCT00834639|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||µg/mL||Standard Deviation|Mean
97797|NCT00834626|Secondary|Percentage of Participants Achieving Remission in Hypertension|Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication|1 year|||Percentage of Participants|||Number
97798|NCT00834626|Primary|Percentage of Participants Having Remission of Type 2 Diabetes|The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped|One year|||Percentage of Participants|||Number
97799|NCT00834626|Secondary|Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents|Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year|one year|||Percentage of Participants|||Number
97800|NCT00834626|Secondary|Percentage of Participants Not Requiring Insulin|After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months|1 year|||Percentage of Participants|||Number
97801|NCT00834613|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97802|NCT00834613|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97803|NCT00834613|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97804|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97805|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one completed subject could not be used to estimate AUC0-inf.||ng*h/mL||Standard Deviation|Mean
97806|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97807|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97808|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97809|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97810|NCT00834574|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97811|NCT00834574|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97812|NCT00834574|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97813|NCT00834561|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97814|NCT00834561|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97815|NCT00834561|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97816|NCT00834535|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97817|NCT00834535|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97818|NCT00834535|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97819|NCT00834522|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97820|NCT00834522|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97821|NCT00834522|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97822|NCT00834483|Secondary|Visual Analog Score, Cosmesis|"Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis.~1 is an unacceptable or poor perspective in regards to wound cosmesis."|6 months|Power analysis described above||units on a scale (1 is a low score)||Full Range|Mean
97823|NCT00834483|Secondary|Cost-analysis|Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs|1 year|Power analysis was performed as above.||Dollars||Standard Deviation|Mean
97824|NCT00834483|Primary|Closure Time|We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated.|6 months|A power analysis was performed based on mean closure times by the 2 surgeons and determined that a sample size of 23 patients in each group would provide 90% power to detect a 50% difference in closure time. To account for patients being lost to FU, we enrolled 29 to the traditional closure group and 31 to the barbed closure group||Average time in minutes||Full Range|Mean
97825|NCT00834444|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97826|NCT00834444|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97827|NCT00834444|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97828|NCT00834431|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97829|NCT00834431|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97830|NCT00834431|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97831|NCT00834418|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97832|NCT00834418|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97833|NCT00834405|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose (Per Participant) - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97834|NCT00834405|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97835|NCT00834366|Secondary|t1/2|Apparent terminal elimination half-life|48 hours|||hours||Standard Deviation|Mean
97836|NCT00834366|Primary|Cmax|Maximum plasma concentration|48 hours|||ng/mL||Standard Deviation|Mean
97837|NCT00834366|Primary|AUC(0-Inf)|Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.|48 hours|||ng.h/mL||Standard Deviation|Mean
97838|NCT00834366|Secondary|Tmax|Time to the maximum concentration|48 hours|||hours||Full Range|Median
97839|NCT00834366|Primary|AUC(0-t)|Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.|48 hours|||ng.h/mL||Standard Deviation|Mean
97840|NCT00834340|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97841|NCT00834340|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for one subject.||ng*h/mL||Standard Deviation|Mean
97842|NCT00834340|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97843|NCT00834288|Secondary|Plateau Time (T75%Cmax)|Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.|24 hours (day 5)|||hours||Standard Deviation|Mean
97844|NCT00834288|Secondary|Half-value Duration (HVD)|Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.|24 hours (day 5)|||hours||Standard Deviation|Mean
97845|NCT00834288|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter recommended by the FDA for submission and is calculated as follows:((Cmax,ss - Cmin,ss)/Cmin,ss)*100. It was calculated over 24 hours on day 5.~Where:~Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state."|24 hours (day 5)|||percentage of fluctuation||Standard Deviation|Mean
97846|NCT00834288|Secondary|Percentage Peak-trough Fluctuation (% PTF)|"Percentage peak-trough fluctuation over 24 hours (24h) at steady state on day 5.~Percent peak-to-trough fluctuation is calculated as (Cmax - Cmin)/Cav*100, where Cmax is the maximum observed concentration, Cmin is the minimum observed concentration and Cav is the average concentration over 24 hours (where Cav = AUCss/24)."|24 hours (day 5)|||percentage of fluctuation||Standard Deviation|Mean
97847|NCT00834288|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure over 24 hours (24h) at steady state on day 5.|24 hours (day 5)|||hours||Full Range|Median
97848|NCT00834288|Secondary|Minimum Plasma Concentration at Steady State(Cmin,ss)|Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.|24 hours (day 5)|||ng/mL||Standard Deviation|Mean
97849|NCT00834288|Secondary|Maximum Plasma Concentration at Steady State(Cmax,ss)|Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.|24 hours (day 5)|||ng/mL||Standard Deviation|Mean
97850|NCT00834288|Primary|Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)|"Area under the plasma concentration versus time data pairs over 24 hours (24h) at steady state, on day 5.~ss = steady state. AUCss is also known as AUCtau."|24 hours (day 5)|||ng*h/mL||Standard Deviation|Mean
97851|NCT00834275|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97852|NCT00834275|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97855|NCT00834249|Secondary|AUC0-inf - O-desmethylvenlafazine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97856|NCT00834249|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97857|NCT00834249|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97858|NCT00834249|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97859|NCT00834249|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97860|NCT00834236|Primary|Number of Participants With Accurate Diagnosis for Gastric Cancer|Normal subject group: number of the subjects with normal alpha 1-antitrypsin level in gastric juice Gastric cancer group: number of the subjects with elevated alpha 1-antitrypsin level in gastric juice|2 months|||participants|||Number
97861|NCT00834210|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts(open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of lesions||Standard Deviation|Mean
97862|NCT00834210|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Scores on a scale||Standard Deviation|Mean
97863|NCT00834210|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized)||Scores on a scale||Standard Deviation|Mean
97864|NCT00834210|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12|Change from baseline in inflammatory lesion count (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).||Number of Lesions||Standard Deviation|Mean
97865|NCT00834197|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
97866|NCT00834197|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
97867|NCT00834197|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
97868|NCT00834171|Primary|Mean Elevated Intraocular Pressure (IOP) During Treatment|Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days.|55 days|Intent to treat, which included all patients in the study.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
97869|NCT00834132|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97870|NCT00834132|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97871|NCT00834132|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97872|NCT00834080|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|2 years (Baseline to end of study)|The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.||participants|||Number
97873|NCT00834067|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97874|NCT00834067|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97875|NCT00834067|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97876|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97877|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97878|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97879|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97880|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
97881|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
97882|NCT00834041|Primary|Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.||mL/h/kg||Standard Deviation|Mean
97883|NCT00834041|Primary|Area Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.||h*ng/mL||Standard Deviation|Mean
97884|NCT00834041|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients|Blood pressure (BP) measurements were made with a mercury sphygmomanometer or an automated blood pressure measuring device. Sitting BP was measured 3 times at 2-3 minute intervals after the patient had been sitting for 5 minutes. Means of the 3 measurements were calculated. A negative change in BP indicates lowered BP.|Baseline to end of treatment (Day 9)|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients.||mmHg||Standard Deviation|Mean
97885|NCT00834041|Secondary|Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9|Blood samples (2 mL) for pharmacodynamics evaluation of plasma renin activity were drawn pre-dose and at 2 and 10 hours following the dose of study medication on Day 1 and at pre-dose and at 2, 10, and 24 hours post-dose on Day 8-9.|Baseline to 2 and 10 hours post-dose on Day 1; pre-dose, 2, 10, and 24 hours post-dose on Day 8-9|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients. Data was not available for all patients at all time points. For each time point, n = the number of subjects for whom data was available for each treatment group.||ng/mL/h||Standard Deviation|Mean
97886|NCT00834041|Primary|Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.||ng/ml||Standard Deviation|Mean
97887|NCT00833976|Secondary|Tolerability of Lovaza||16 weeks||||||
97888|NCT00833976|Secondary|Decrease in Total Cholesterol||16 weeks||||||
97889|NCT00833976|Primary|Change in Triglycerides From Baseline to 16 Weeks||16 weeks|||mg/dL||Standard Deviation|Mean
97890|NCT00833937|Primary|AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97891|NCT00833937|Primary|AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97893|NCT00833924|Primary|Patients With Device Failures|"Device success at 12-month is defined as:~Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm."|12-month|There were 5 patients died, and 2 patients withdrew.||participants|||Number
97894|NCT00833924|Primary|Patients With Major Adverse Events (MAE)|MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.|30-day|1 patient experienced a re-intubation, which was adjudicated by the CEC as not related to AAA repair (related to a pre-existing condition).||participants|||Number
97895|NCT00833911|Primary|Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation|Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population|6 months and 12 months|"All patients having taken 1 dose of 300 mg Tramadol HCl OAD at a minimum are being assessed for adverse event occurence for up to 12 months.~6-months safety: patients who completed at least 175 days on treatment.~12-months safety: patients who completed at least 350 days on treatment."||participants|||Number
97896|NCT00833898|Secondary|Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)|Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
97897|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 10 (IL-10)|Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
97898|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 4 (IL-4)|Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
97899|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 6 (IL-6)|Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 11). Caregiver Intervention group: missing responses (n = 4).||ln(pg/mL)||95% Confidence Interval|Mean
97900|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)|Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test||pg/mL||Standard Deviation|Median
97901|NCT00833898|Secondary|Plasma C-reactive Protein (CRP)|Plasma c-reactive (CRP) is an acute phase reactant that has been found to be predictive of cardiovascular disease. Is is also an inflammatory marker that will be assessed using high sensitivity CRP assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 6).||ln(mg/L)||95% Confidence Interval|Mean
97902|NCT00833898|Secondary|Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity|The activity of natural killer (NK) cells is modified by psychosocial and behavioral states (Cacioppo et al., 1998; Irwin et al., 1991; Kiecolt-Glaser et al., 1991; Kiecolt-Glaser, 1999; Kiecolt-Glaser, McGuire, Robles, et al., 2002a; Kiecolt-Glaser, McGuire, Robles, et al., 2002b). Natural cytotoxicity will be determined toward K562 target cell lines as previously described (Laudenslager et al., 1998; Scanlan, et al., 1995). Percent lysis at each effector to target ratio will be found from the median value of each triplicate determination and from which the percent lysis/NK + cell will be determined for 20% lysis (lytic units/NK+ cell).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).||ln(% Lysis/NK+ Cell)||95% Confidence Interval|Mean
97903|NCT00833898|Secondary|Area Under the Curve for Salivary DHEA (AUCd)|The AUCd will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total DHEA released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
97904|NCT00833898|Secondary|Area Under the Curve for Salivary Cortisol (AUCc)|The AUCc will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total cortisol released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
97905|NCT00833898|Secondary|The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)|The SlopeD has been noted to be affected by affective disorders such as depression. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and +10 hours after awaking to characterize the diurnal change in salivary DHEA.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 15).||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
97906|NCT00833898|Secondary|The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)|The SlopeC has been noted to be affected by stressful experiences. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and 10 hours after awaking to characterize the diurnal change in salivary cortisol (SlopeC).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 12). Caregiver Intervention group: missing responses (n = 12).||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
97918|NCT00833859|Secondary|Number of Participants With Objective Response|We planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.|6 months per patient||||||
97907|NCT00833898|Secondary|Stress as Measured by the Impact of Events Scale (IES)|The Impact of Events Scale (IES), a widely accepted measure for evaluating intrusive thoughts regarding an event or situation. The scale consists of 15 items (7 measuring intrusive thoughts and 8 measuring avoidance) scored on a 5-point Likert Scale. Minimum score (best value)=0. Maximum score (worst value)=75. Scores over 20 indicate significant levels of PTS-like symptoms. The IES is anchored to the caregiving experience.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).||units on a scale||95% Confidence Interval|Mean
97908|NCT00833898|Secondary|Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).||units on a scale||95% Confidence Interval|Mean
97909|NCT00833898|Secondary|Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Role emotional, social functioning and mental health contribute to mental component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).||units on a scale||95% Confidence Interval|Mean
97910|NCT00833898|Secondary|Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, where scores greater than 5 indicate poor sleep quality.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
97911|NCT00833898|Secondary|Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)|The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale refers to the caregiver. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
97912|NCT00833898|Secondary|Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)|POMS stands for the Profile of Mood States. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1) tension-anxiety, 2) depression-dejection, 3) anger-hostility, 4) fatigue-inertia, 5) vigor-activity and 6) Confusion-bewilderment. A Total Mood Disturbance (TMD) can be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigour. The range for the Total Mood Disturbance (TMD) score is 0 – 200, with higher score indicating more mood disturbance.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
97913|NCT00833898|Secondary|State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)|The State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).||units on a scale||95% Confidence Interval|Mean
97914|NCT00833898|Secondary|Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)|The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report 20-item scale designed to measure current depressive symptoms. Scores range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 2).||units on a scale||95% Confidence Interval|Mean
97915|NCT00833898|Primary|Physiological - Cortisol Awakening Response (CAR)|Saliva will be collected using SPIT booklets containing four separate filter papers corresponding to collection times separated by waxed paper. Subjects will be asked to moisten a filter paper 1) immediately after waking, 2) 30 min later, 3) before lunch and 4) 10 hours after waking. They will be asked to collect these samples on three days typical for their schedules at each phase of the. They will indicate the time of each collection. Filters will dry in the booklet. Saliva samples will be aggregated across the three sampling days at each study phase to better reflect the typical pattern for each subject (see Smyth et al, 1997). The change from awakening to 30 minutes in cortisol (CAR) will be characterized by the change between waking and 30 min.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 15). Caregiver Intervention group: missing responses (n = 15).||ln(nmol/L)||95% Confidence Interval|Mean
97916|NCT00833898|Primary|Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).||units on a scale||95% Confidence Interval|Mean
97919|NCT00833859|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).|We planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.|6 months per patient||||||
97920|NCT00833859|Primary|Number of Participants With Resectability|The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.|||||
97921|NCT00833833|Primary|Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off|"Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
97922|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off|"Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"ITT population.~Data collection is ongoing and future data results will be included as available."||weeks||95% Confidence Interval|Median
97923|NCT00833833|Secondary|Phase 2: Time to Response as of the 01 April 2011 Cut-off|"Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Responders (participants achieving CR or PR) from ITT population.~Data collection is ongoing and future data results will be included as available."||weeks||Full Range|Median
97924|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off|"Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome."|up to 70 weeks|"Responders (participants with a complete response or partial response) from the ITT population.~Data collection is ongoing and future data results will be included as available."||weeks||95% Confidence Interval|Median
97925|NCT00833833|Secondary|Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off|"IRAC used EBMT criteria to assess myeloma response:~Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)~Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others~Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others~Stable Disease (SD)- not MR or progressive disease (PD)~Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other~Not Evaluable (NE).~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
97926|NCT00833833|Secondary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 70|"Safety population.~Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
97927|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off|"TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.~Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 126|"Safety population.~Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
97928|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 104|"Safety population.~Data collection is ongoing and future data results will be included as available."||percentage of participants|||Number
97929|NCT00833833|Primary|Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off|"Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.~Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."||weeks||95% Confidence Interval|Median
97930|NCT00833833|Primary|Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1|"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.~DLTs were defined as:~Grade 4 neutropenia or thrombocytopenia~Febrile neutropenia~Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment~Serum transaminase > 20 * upper limit of normal (ULN)~Serum transaminase > 5 * ULN for >= 7 days~Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event"|Up to Day 28 (Cycle 1)|Safety population||participants|||Number
97931|NCT00833521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97932|NCT00833521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
97933|NCT00833521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
97934|NCT00833482|Secondary|Number of Participants With Abnormalities in Vital Signs||Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
97935|NCT00833482|Secondary|Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator|volt=voltage; LVH=left ventricular hypertrophy|Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
97936|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If <.85*LLN or >1.15*ULN or ULN or if preRX<LLN, use <0.85*preRX or >ULN; if preRX>ULN, use >1.15*preRX or <LLN. Lymphocytes, relative: If <0.85*LLN or >1.15*ULN, or if preRX <LLN, use <0.85*preRX or >ULN; if preRX >ULN, use >1.15*preRX or <LLN. Blood, urine: If >= 2+, or if preRX >=1+, use >=2*preRX. White blood cells, urine: If >=2+, or if preRX >=2+, use >=4+. Red blood cells, urine: If >=2+ or if preRX >=2+, use >=4+. Not all categories were evaluated for each arm.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
97937|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Serum Chemistry Test Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If >1.25*ULN, or if preRX>ULN, use >1.25*preRX. Total and direct bilirubin: If >1.1*ULN or if preRX>ULN, use >1.25*preRX. Creatinine: If >1.33*preRX. Serum glucose, fasting: If preRX<LLN, use <.8*preRX or >ULN; if preRX>ULN, use >2*preRX or <LLN. Creatinine kinase: If >1.5*ULN or preRX>ULN, use >1.5*or preRX. Lactose dehydrogenase: If >1.25*ULN or preRX>ULN, use >1.5*preRX.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.||Participants|||Number
97938|NCT00833482|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 to 31 (discharge), continuously|All participants who received study drug.||Participants|||Number
97939|NCT00833482|Secondary|AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
97968|NCT00833248|Secondary|Change From Baseline in Serum Testosterone Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||nanograms per milliliter||Full Range|Median
97940|NCT00833482|Primary|AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
97941|NCT00833482|Primary|Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
97942|NCT00833482|Primary|Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||Hours||Full Range|Median
97943|NCT00833482|Secondary|Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||Hours||Full Range|Median
97944|NCT00833482|Secondary|Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
97945|NCT00833482|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
97946|NCT00833482|Primary|Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||Hours||Full Range|Median
97947|NCT00833482|Primary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM)|EM participants are those with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
97948|NCT00833469|Secondary|Change in Beck Anxiety Inventory (BAI)|Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.||units on a scale||Standard Deviation|Mean
97949|NCT00833469|Secondary|Change in Edinburgh Postnatal Depression Scale (EPDS)|The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.||units on a scale||Standard Deviation|Mean
97950|NCT00833469|Primary|Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.||units on a scale||Standard Deviation|Mean
97951|NCT00833443|Post-Hoc|End of Treatment Methamphetamine Abstinence||12 weeks|||participants|||Number
97952|NCT00833443|Secondary|Treatment Retention||12 weeks|||days||Standard Deviation|Mean
97953|NCT00833443|Primary|End of Treatment Methamphetamine Abstinence|Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)|12 weeks|||participants|||Number
97954|NCT00833443|Primary|Treatment Effectiveness Score|The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)|12 weeks|||urine drug screens||Standard Deviation|Mean
97955|NCT00833417|Secondary|Percentage of Patients With Absence of Residual Basal Cell Carcinoma (BCC) in Patients With Locally Advanced BCC|In patients with locally advanced BCC, the histopathological effect of vismodegib was determined in tissue biopsies obtained at baseline and following vismodegib treatment. Reported are the percentage of patients with pathology confirmed BCC in baseline biopsy who had an absence of residual BCC post-baseline as assessed by an independent pathological review.|From baseline through end of the study, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma. Only locally advanced BCC patients with available post-baseline biopsy assessed by an independent pathologist were included in the analysis.||Percentage of participants|||Number
97956|NCT00833417|Secondary|Change From Baseline in Short Form 36 (SF-36) Health Survey Scores|The SF-36 Health Survey (Version 2) uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline, Week 12, Week 24, and at the end of the study or early termination visit, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Units on a scale||95% Confidence Interval|Mean
97957|NCT00833417|Secondary|Overall Survival|Overall survival was defined as the time from the initial dose of vismodegib until death from any cause.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Months||95% Confidence Interval|Median
97958|NCT00833417|Secondary|Progression-free Survival (PFS) Determined by the Independent Review Facility|PFS was defined as the time from start of treatment to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Months||95% Confidence Interval|Median
97959|NCT00833417|Secondary|Duration of Objective Response (OR) Determined by the Independent Review Facility|Duration of OR was defined as the time from the initial CR or PR to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Months||95% Confidence Interval|Median
97960|NCT00833417|Primary|Objective Response (OR) Determined by the Independent Review Facility|OR=complete (CR) or partial response (PR). Metastatic-CR:Disappearance of all targets. PR:≥30% decreased sum of longest diameter (SLD) of targets compared to baseline (B). Locally advanced-Response=No progressive disease (PD) and ≥30% decreased SLD from baseline (radiography [R]) or ≥30% decreased SLD from B (externally visible dimension [EVD]) or completely resolved ulceration. CR:Response with no residual BCC on tumor biopsy (otherwise response was PR). PD:Any of ≥20% increased SLD from nadir (R or EVD), new ulceration, new lesions (R or physical exam) or non-target lesion progression by R.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.||Percentage of participants||95% Confidence Interval|Number
97961|NCT00833365|Secondary|Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration||1 and 6 hours|Due to early termination of the study, labs were not analyzed.|||||
97962|NCT00833365|Primary|Number of PDA Closures Related to Treatment With Ibuprofen|Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.|Within 48 hrs of ibuprofen round|Premature infants born at 23+3 weeks to 29+4 weeks with positive patent ductus arteriosus on cardiac echogram were randomized to early or late treatment with ibuprofen. 2 babies which had been originally randomized to the late treatment arm never got ibuprofen and are not included in analysis.||closures related to treatment|||Number
97963|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety analysis set.||participants|||Number
97964|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety analysis set.||participants|||Number
97965|NCT00833248|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||scores on a scale||Standard Deviation|Mean
97966|NCT00833248|Secondary|Change From Baseline in Serum Oestradiol Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||nanogram per deciliter||Full Range|Median
97967|NCT00833248|Secondary|Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||nanograms per milliliter||Full Range|Median
97983|NCT00832975|Secondary|Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure||24 months|||Patients|||Number
97969|NCT00833248|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.||scores on a scale||Standard Deviation|Mean
97970|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, OC.||milliliter||Standard Deviation|Mean
97971|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, Observed Case (OC) i.e. only participants with a reported value were included in the analysis.||milliliter||Standard Deviation|Mean
97972|NCT00833092|Primary|Global Pittsburgh Sleep Quality Index|Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.|9 weeks|Data from 4 participants (3 on sugar pill, 1 on magnesium) were omitted from statistical analysis because of protocol violations discovered near end of study.||score on a scale||Standard Error|Mean
97973|NCT00833053|Secondary|Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28|The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
97974|NCT00833053|Secondary|Dermatology Life Quality Index (DLQI) at Week 28|The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.|Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
97975|NCT00833053|Secondary|Change From Baseline in Mean Participant Raw PASI Scores at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
97976|NCT00833053|Secondary|Number of Participants With A PASI-100 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
97977|NCT00833053|Secondary|Number of Participants With A PASI-90 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
97978|NCT00833053|Secondary|Number of Participants With A PASI-50 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.|||||
97979|NCT00833053|Primary|Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28|The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.|Baseline, Week 28|||Participants|||Number
97980|NCT00833040|Primary|Time-weighted SPID30|time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.|30 minutes after dosing|Intent to treat population defined as all patients who took at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
97981|NCT00833027|Secondary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 12|Includes all patients who received at least one dose of study medication and have a Week 12 measure.||Percent||Standard Deviation|Mean
97982|NCT00833027|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 24|Includes all patients who received at least one dose of study medication and have a Week 24 measure.||Percent||Standard Deviation|Mean
97984|NCT00832975|Primary|Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)|Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec|24 months|157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it||Episodes|||Number
97985|NCT00832871|Other Pre-specified|Overall Survival|The time from patient entry into the protocol to death by any cause.|5 years|||Months||Standard Deviation|Median
97986|NCT00832871|Secondary|Toxicity Associated With Adrenal Insufficiency|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts the following events of interest, which are related to possible adrenal insufficiency: nausea, vomiting, lethargy, dizziness, fatigue, anorexia, and skin rash. Any grade of these events that are self-reported by patients as well as events identified by physician assessment (e.g. physical exam) will be included.|Up to 8 weeks after the end of study treatment|All patients received at least one dose of study medication and are included in this analysis.||percentage of participants|||Number
97987|NCT00832871|Primary|Duration of Response|The time from the date of response (not the beginning of treatment unless there is stable disease) to disease progression. Response and progression are evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years|Only one patient achieved stable disease. This patient's duration of response could therefore be reported. The other three patients progressed on treatment.||days||Full Range|Median
97988|NCT00832819|Secondary|To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.|Refer safety section for safety analysis|Throughout the study until 30 days after last dose||||||
97989|NCT00832819|Secondary|Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.||At various time points until Day 22 of Cycle 1||||||
97990|NCT00832819|Primary|Maximum Tolerated Dose (MTD)|Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.|7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1|DLTs were analyzed on the Safety Analysis Set; however subjects with 75% or less treatment compliance for E7080 in Cycle 1 or those who discontinued the study and had no confirmed data on tolerability up to Cycle 1 Day 22 were excluded from this analysis.||mg BID|||Number
97991|NCT00832819|Secondary|Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.||At Screening, on Day 22 of every even cycle, and at discontinuation||||||
97992|NCT00832650|Secondary|Mean Proportion of Bowel Movements With Satisfaction Per Day|The number of stools with satisfaction of “Yes” divided by the total number of stools passed on each notional day. Mean of 3 days.|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||mean proportion||Standard Deviation|Mean
97993|NCT00832650|Secondary|Average Score of Ease of Passage During Defecation Per Day|Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||score on a scale||Standard Deviation|Mean
97994|NCT00832650|Secondary|Mean Score of Stool Consistency Per Day|Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||score on a scale||Standard Deviation|Mean
97995|NCT00832650|Secondary|Mean Number of Stools Per Day|Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.||stools||Standard Deviation|Mean
97996|NCT00832650|Secondary|Time to Gastric Emptying|Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12: 2 hours, 4 hours|ITT included all randomized subjects. Imputation by overall mean for missing data.||minutes||Standard Deviation|Mean
97997|NCT00832650|Secondary|Colonic Filling at 6 Hours|A surrogate marker of small bowel transit time.|Day 12|ITT included all randomized subjects. Imputation by overall mean for missing data.||percentage||Standard Deviation|Mean
97998|NCT00832650|Secondary|Colonic Transit at 48 Hours|Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 14 (Day 12 48 hours post-meal)|ITT included all randomized subjects. Imputation by overall mean for missing data.||counts||Standard Deviation|Mean
97999|NCT00832650|Secondary|Proximal Colonic Emptying Time|Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12 to 14|ITT included all randomized subjects. Imputation by overall mean for missing data.||hours||Standard Deviation|Mean
98042|NCT00832130|Primary|Incidence of Device-related Adverse Events|Number of eyes for which a device-related AE occurred|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population.||Events|Participants||Number
102271|NCT00795951|Primary|Diagnostic Performance: Carba Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
98000|NCT00832650|Primary|Colonic Transit at 24 Hours|Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 13 (Day 12 24 hours post-meal)|Intent to treat (ITT) included all randomized subjects. Imputation by overall mean for missing data.||counts||Standard Deviation|Mean
98001|NCT00832637|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events).|Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeks|||participants|||Number
98002|NCT00832637|Secondary|Median Survival Time (MST)|Survival is defined as the time from treatment initiation to death by any cause|2 years|||weeks||95% Confidence Interval|Median
98003|NCT00832637|Secondary|Time to Tumor Progression (TTP)|The time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|||weeks||95% Confidence Interval|Median
98004|NCT00832637|Secondary|Overall Response Rate|"Overall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks|||percentage of evaluable participants|||Number
98005|NCT00832637|Primary|Tumor Control Rate|"Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks|||percentage of evaluable participants|||Number
98006|NCT00832624|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18|Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.|Baseline and Week 18|The study was terminated early and no data were analyzed for this outcome.|||||
98007|NCT00832585|Secondary|Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.|The Physician Global Assessment (PGA) evaluates the overall severity of Atopic Dermatitis (AD) at a given time using a four point scale (0=clear, 0.5=clear to mild, 1=mild, 1.5=mild to moderate, 2=moderate, 2.5=moderate to severe, and 3=severe).|Week 1 to week 16|||Scores on a scale||Full Range|Median
98008|NCT00832585|Primary|Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.|The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.|Week 1 to week 16|8 (4 female and 4 male) atopic patients, ranging in age from 24 to 54 yrs of age, were screened for the study. 5 patients were enrolled for 12 wks of treatment, but only 3 completed the study.||Scores on a scale.||Full Range|Median
98009|NCT00832572|Secondary|Response to Thermal and Mechanical Stimuli|The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.|||||
98010|NCT00832572|Secondary|Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire|The participant quality of life assessed utilizing the SF-36v2 questionnaire|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.|||||
98011|NCT00832572|Primary|Reduction in Neuropathic Pain|Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)|Baseline to Week 6|Study was stopped and no analysis was performed on the primary outcome measure.|||||
98012|NCT00832520|Secondary|To Determine if the Quality of Life Improves After Starting Mirtazapine||8 weeks||||||
98013|NCT00832520|Primary|Change in Weight||8 weeks|There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.|||||
98307|NCT00830115|Primary|Physician's Assessment of Sleep Disturbances|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
98014|NCT00832455|Other Pre-specified|Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)|"The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ).~PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described."|Weeks 4, 8, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Units on a Scale||Standard Deviation|Mean
98015|NCT00832455|Other Pre-specified|Patient Global Satisfaction|At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|Week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Participants|||Number
98016|NCT00832455|Other Pre-specified|Physician Global Satisfaction|At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.|week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Participants|||Number
98017|NCT00832455|Secondary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.||Participants|||Number
98018|NCT00832455|Primary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4 and the 373 patients who completed week 12.||Participants|||Number
98019|NCT00832416|Secondary|Percentage of Participants Who Dropped Out From Trial by Dropout Reason|Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.||percentage of participants|||Number
98020|NCT00832416|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
98021|NCT00832416|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient’s overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.||participants|||Number
98022|NCT00832416|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||mm||Standard Deviation|Mean
98023|NCT00832416|Secondary|Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
98024|NCT00832416|Secondary|Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
98308|NCT00830115|Primary|Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 846~Day 1 = 841~Day 2 = 828~Day 3 = 817~Day 4 = 800~Day 5 = 791~Day 6 = 790"||Units on a scale||Standard Deviation|Mean
98025|NCT00832416|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.||Percentage difference||Standard Deviation|Mean
98026|NCT00832416|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.||participants|||Number
98027|NCT00832390|Primary|Change From Baseline in A1C at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 Weeks|||Percent Difference||95% Confidence Interval|Mean
98028|NCT00832377|Other Pre-specified|Baseline IOP|"Baseline IOP was measured at ~9 AM of first day of treatment period.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline|||mmHg||Standard Deviation|Mean
98029|NCT00832377|Secondary|Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks|||mmHg||Standard Deviation|Mean
98030|NCT00832377|Secondary|Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks|||mmHg||Standard Deviation|Mean
98031|NCT00832377|Primary|Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks|||mmHg||Standard Deviation|Mean
98032|NCT00832299|Secondary|Observation of Overall Pathologic Response Rate, Correlation of Pathologic Staging With Pre-op Ultrasound and Pelvic MRI Staging Observed Toxicities Patterns of Disease Relapse Disease-free Survival Overall Survival||5 years||||||
98033|NCT00832299|Primary|Pathologic Complete Response||3-6 months|Because only 2 subjects were enrolled, no analysis was performed. There is no data to report.|||||
98034|NCT00832260|Secondary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).||12 months|||percentage of patients|||Number
98035|NCT00832260|Primary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.||12 months|||percentage of patients|||Number
98036|NCT00832130|Primary|Tear Break-up Time|Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.||Seconds|Participants|Standard Deviation|Mean
98037|NCT00832130|Secondary|Discomfort Evaluation (Discomfort/Pain Score)|Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.|Treatment and 1 Day|Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment.||Scores on a scale|Participants|Standard Deviation|Mean
98038|NCT00832130|Secondary|(LogMAR) Best Spectacle Corrected Visual Acuity|Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.|Baseline, 2 Weeks and 4 Weeks|Results presented are of the Intent to Treat population. 2 Weeks data for the Control group are after control treatment, but before crossover treatment. 4 Weeks data for the Control group are after crossover treatment.||LogMAR|Participants|Standard Deviation|Mean
98039|NCT00832130|Secondary|Intraocular Pressure|Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.|Baseline through 4 Weeks|Results presented are of the Intent to Treat population. Post-Treatment results for the Control group are before crossover treatment. 4 Weeks results for the Control group are after crossover treatment.||mmHg|Participants|Standard Deviation|Mean
98040|NCT00832130|Secondary|Ocular Surface Staining (Corneal Staining Sum Score)|Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover.||Scores on a scale|Participants|Standard Deviation|Mean
98041|NCT00832130|Secondary|Dry Eye Symptoms (Total SPEED Score)|Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.||Scores on a scale|Participants|Standard Deviation|Mean
98043|NCT00832130|Primary|Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)|Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.||Scores on a scale|Participants|Standard Deviation|Mean
98044|NCT00832117|Secondary|Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 <LLN - 10.0 g/dL; Gr2 <10.0 - 8.0 g/dL; Gr3 <8.0 - 6.5 g/dL; Gr4 <6.5 g/dL. White Blood Cell Count (WBC) Gr1 <lower limit of normal (LLN) - 3000/mm^3; Gr2 <3000 - 2000/mm^3; Gr3 <2000 - 1000/mm^3; Gr4 <1000/mm^3. Absolute Neutrophil Count (ANC) Gr 1 <LLN - 1500/mm^3; Gr 2 <1500 - 1000/mm^3; Gr3 <1000 - 500/mm^3; Gr 4 <500/mm^3. Platelets Gr1 <LLN - 75,000/mm^3; Gr2 <75,000 - 50,000/mm^3; Gr3 <50,000 - 25,000/mm^3; Gr4 <25,000/mm^3. Normal ranges vary by local laboratory.|Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants||participants|||Number
98045|NCT00832117|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants||participants|||Number
98046|NCT00832117|Secondary|Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC)|The duration of response will be computed for all treated subjects whose best response is either partial response (PR) or complete response (CR). The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. Subjects who neither relapse nor die will be censored on the date of their last tumor assessment.|The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.)|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.|||||
98047|NCT00832117|Secondary|Percentage of Participants With Response|Response in participants with non-small cell lung cancer (NSCLC) was defined as the number of subjects in whose best response is partial response (PR) or complete response (CR) (see Outcome Measure 3 for definitions) divided by the total number of response evaluable subjects.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.|||||
98048|NCT00832117|Primary|Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.|Within the first 21 days of first cycle|All subjects who received at least 1 dose of either ixabepilone or carboplatin||mg/m^2|||Number
98049|NCT00832117|Secondary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) & all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of >=1 NTL (NonCR/NonPD) + no NWL; OR >=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):>=20% increase in sum of LD of TL regardless of NTL & NWL status; or unequivocal progression of NTL regardless of TL & NWL status; or NWL regardless of TL & NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|All treated participants||participants|||Number
98050|NCT00832117|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for >3 weeks;Gr4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever >38.5°C;thrombocytopenia <25,000 cells/mm^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.|Within the first 21 days of first cycle|all treated participants||participants|||Number
98051|NCT00832091|Secondary|Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers|Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84|Up to 84 days|Analysis per protocol, Intent-to-treat (ITT), using Last Observation Carried Forward (LOCF)||Participants|||Number
98066|NCT00832000|Secondary|Quantitative Measure of Hand Grip Myotonia (Seconds)|Maximum voluntary contractions following forced right hand grip were recorded and the time to relax from 90% to 5% of average maximal force was determined using automated analysis software.|The end of period 1 (week 4) and period 2 (week 9)|All participants with quantitative handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean using log (t+0.1) 'normalizing' transformation. Confidence intervals are bootstrap confidence intervals.||seconds||95% Confidence Interval|Mean
98052|NCT00832091|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days|All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE|Up to 84 days|Analysis per protocol, ITT, using LOCF||SAEs and AEs|||Number
98053|NCT00832078|Secondary|Haematuria||After each catheterisation||||||
98054|NCT00832078|Secondary|Preference||At study termination||||||
98055|NCT00832078|Secondary|Handling||After each catheterisation||||||
98056|NCT00832078|Primary|Discomfort|Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)|After each catheterisation|The number analized was the number of participants catherised with each catheter at least onze during the study(SC or SCCM)||units on a scale||Standard Deviation|Mean
98057|NCT00832000|Secondary|Short Form 36 - Mental Composite Score|The SF-36 is a standard quality of life instrument. The mental composite score represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|The end of period 1 (week 4) and period 2 (week 9)|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98058|NCT00832000|Secondary|Short Form 36 - Physical Composite Score|The SF-36 is a standard quality of life instrument. The physical composite score represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|Particiapnts who experienced weakness on mexiletine in either period 1 or period 2.|All participants with SF-36 physical composite values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98059|NCT00832000|Secondary|Individualized Neuromuscular Quality of Life Scale - Summary Score|Quality of life scale for patinets with neuromuscular disorders. The INQoL summary score is a weighted average made up of 5 subdomains (activities, social relationships, independence, emotions, and body image) which document the impact of a disease on a patients' quality of life. Scores range from 0-100, and can be interpreted as the percent of maximal detrimental impact on quality of life. A higher score indicates more detrimental impact.|The end of period 1 (week 4) and period 2 (week 9)|All participants with INQoL summary score values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98060|NCT00832000|Secondary|Compound Motor Action Potentials After Long Exercise Test|Compound muscle action potential (CMAP) after long periods of exercise as a percentage of baseline.|The end of period 1 (week 4) and period 2 (week 9)|All participants with long exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
98061|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Tibialis Anterior|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RTA values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98062|NCT00832000|Secondary|Clinical Eye Closure Myotonia Evaluation (Seconds)|Time to open the eyes after forced eye closure as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical eye closure myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.||Seconds||95% Confidence Interval|Mean
98063|NCT00832000|Secondary|Clinical Hand Grip Myotonia Evaluation (Seconds)|The time to open the fist after a forced handgrip as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.||Seconds||95% Confidence Interval|Mean
98064|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Abductor Digiti Minimi|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RADM values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98065|NCT00832000|Secondary|Compound Motor Action Potentials After Short Exercise Test|The maximal post-exercise compound muscle action potential (CMAP) after short periods of exercise as a percent of the baseline measurement.|The end of period 1 (week 4) and period 2 (week 9)|All participants with short exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
99537|NCT00818961|Secondary|Neutrophil Recovery|The number of patients experiencing neutrophil recovery post transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of neutrophil recovery||participants|||Number
98067|NCT00832000|Secondary|Patient Reported Tiredness on the IVR|Tiredness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of tiredness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|49 partipants who experienced tiredness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98068|NCT00832000|Secondary|Patient Reported Weakness on the IVR|Weakness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of weakness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|44 partipants who experienced weakness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98069|NCT00832000|Secondary|Patient Reported Pain on the IVR|Pain measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of pain for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeeks 3-4 of each period|48 partipants who experienced pain in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98070|NCT00832000|Primary|Patient-reported Stiffness on the IVR|Stiffness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of stiffness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.||units on a scale||95% Confidence Interval|Mean
98071|NCT00831987|Primary|Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||Day 21 post-vaccination|||Percentage of Participants|||Number
98072|NCT00831987|Primary|Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||21 Days post-vaccination|||Percentage of Participants|||Number
98073|NCT00831987|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine|GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.|Day 0 and Day 21 Post-Vaccination|Geometric Mean Titers were assessed in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
98074|NCT00831987|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination|"Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site.~Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia"|0 to 3 days post-vaccination|||Percentage of Participants|||Number
98075|NCT00831844|Primary|Disease Response|Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).|First six treatment cycles - 24 weeks|Grp 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Grp 3, 21 enrolled, 1 ineligible. Grp 5, 14 enrolled, 1 ineligible. Grp 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).||patient|||Number
98076|NCT00831766|Other Pre-specified|Median Relapse-Free Survival (RFS)|Relapse-Free Survival (RFS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be analyzed similarly. Descriptive analysis was planned for this measure.|24 Months||||||
98077|NCT00831766|Other Pre-specified|Median Overall Survival (OS)|Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure.|24 Months||||||
98078|NCT00831766|Other Pre-specified|Rate of Cytogenetic Remission Following Induction Therapy|Rate of cytogenetic remission following induction therapy. Descriptive analysis was planned for this measure.|24 Months||||||
98079|NCT00831766|Secondary|Median Progression-Free Survival (PFS)|Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve.|24 months||08/2017||||
98080|NCT00831766|Secondary|Rate of Lenalidomide Related Toxicity During Maintenance Therapy|Rate of toxicities of lenalidomide as maintenance therapy according to the National Cancer Institute Common Toxicity Criteria (CTC) V3.|24 months||08/2017||||
98081|NCT00831766|Primary|Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)|Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).|24 months|All participants treated at MTD||percentage of participants|||Number
98082|NCT00831766|Primary|Phase I: Recommended Phase II Dose|For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.|18 months|Phase I participants.||mg/day|||Number
98124|NCT00831389|Secondary|Overnight Nadir Plasma Glucose (PG)|For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.|Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
98083|NCT00831753|Secondary|Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable."|Day 0 up to Day 7 after each injection|Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
98084|NCT00831753|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.|Day 150 (1 month after dose 3)|Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
98085|NCT00831753|Primary|Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as:~Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL.~Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL."|Day 150 (1 month after dose 3)|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
98086|NCT00831753|Primary|Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™|Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 150 (1 month after dose 3)|Seroprotection against Hep B was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
98087|NCT00831701|Secondary|Number of Participants Requiring Active Treatment|The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.|21 days|||participants|||Number
98088|NCT00831701|Secondary|Maximum Daily Pain Score|All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).|Until stone expulsion or up to 21 days|||Units on a scale||Full Range|Median
98089|NCT00831701|Secondary|Required Analgesics|Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day|Until stone expulsion or up to 21 days|||pills per day||Inter-Quartile Range|Median
98090|NCT00831701|Secondary|Time to Stone Passage|The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.|21 days|||days||Inter-Quartile Range|Median
98091|NCT00831701|Primary|Number of Participants With Stone Expulsion|The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).|21 days|||Participants|||Number
98092|NCT00831675|Other Pre-specified|Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)|Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.|Day 14 post-vaccination|Seroconversion were evaluated in the per-protocol population.||Percentage of Participants|||Number
98093|NCT00831675|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.|14 days post-vaccination|Seroprotection were evaluated in the per-protocol population||Percentage of Participants|||Number
98094|NCT00831675|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation||14 days post-vaccination|GMTs were evaluated in the per-protocol population||Titers||95% Confidence Interval|Geometric Mean
98095|NCT00831675|Primary|Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation|"Solicited local reactions: Erythema, bruising, induration, pain at injection site.~Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection."|Days 0-3 Post-dose|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population||Participants|||Number
98096|NCT00831493|Primary|Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation|MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).|Toxicity assessment at 6 weeks following chemoradiation (6 weeks)|Analysis per protocol; Of the three participants enrolled only two were eligible for MTD calculation.||mg|||Number
98125|NCT00831389|Secondary|Nadir Plasma Glucose (PG) Immediately Following Exercise|The PG nadir observed following the start of exercise|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
98097|NCT00831480|Primary|Disease Progression Diagnosed by Biopsy|Clinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.|up to one year|||participants|||Number
98098|NCT00831441|Secondary|Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants|Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
98099|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants|ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
98100|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants|ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
98101|NCT00831441|Primary|Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants|TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.||percentage of participants/100-pt years|||Number
98102|NCT00831441|Secondary|Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|"Cause of death was determined by the principal condition that caused the death, not the immediate mode of death.~CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination)."|Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
99561|NCT00818779|Secondary|Serum Level of C-reactive Protein||6 week||||||
98103|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
98104|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
98105|NCT00831441|Secondary|Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants|Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination.|Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
98106|NCT00831441|Secondary|Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants|MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (≥0.04 s) Q waves in ≥2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice.|Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
98107|NCT00831441|Secondary|Event Rate of Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
98108|NCT00831441|Secondary|Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants|Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
98126|NCT00831389|Secondary|Peak Post-prandial Plasma Glucose (PG)|For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.|Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
98109|NCT00831441|Primary|Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.||percentage of participants/100-pt years|||Number
98110|NCT00831428|Secondary|Mini Nasal Lavage||This test will be performed prior to entering the pool, and on exiting the pool||||||
98111|NCT00831428|Secondary|Skin Prick Test||This test will be performed once on a district and once on a national squad training day||||||
98112|NCT00831428|Secondary|Nasal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool||||||
98113|NCT00831428|Primary|Tidal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool|Data from all participants was analysed||ppb||95% Confidence Interval|Geometric Mean
98114|NCT00831428|Secondary|Sport-based Challenge||This test will be performed once on a district and once on a national squad training day||||||
98115|NCT00831428|Secondary|Mannitol Challenge||This test will be performed once on a district and once on a national squad training day||||||
98116|NCT00831415|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.|Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment|Safety population: all enrolled participants who received at least 1 dose of study treatment in this extension study.||percentage of participants|||Number
98117|NCT00831415|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score|CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.|Baseline (Extension Study) up to Day 308 or FOT Evaluation|ITT; LOCF and Observed cases (non-missing data); (n)=number of participants with analyzable data at observation.||scores on a scale||95% Confidence Interval|Mean
98118|NCT00831415|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Day 308 or FOT Evaluation|ITT; LOCF. Improvement measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).||participants|||Number
98119|NCT00831415|Primary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score|"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last on-therapy evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit."|Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation|Intent to treat (ITT): all enrolled participants who received at least 1 dose of study treatment in Extension Study and at least 1 available post-baseline evaluation for any endpoint; (n)=number of participants with analyzable data at observation.||scores on a scale||95% Confidence Interval|Mean
98120|NCT00831389|Post-Hoc|Overall Incidence of Hypoglycemia|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||hypoglycemic events||Inter-Quartile Range|Median
98121|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||percentage of time||Inter-Quartile Range|Median
98122|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||percentage of time||Inter-Quartile Range|Median
98123|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.|For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis||percentage of time||Inter-Quartile Range|Median
98309|NCT00830115|Primary|Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)|Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 869~Day 1 = 868~Day 2 = 867~Day 3 = 864~Day 4 = 863~Day 5 = 859~Day 6 = 862"||Units on a scale||Standard Deviation|Mean
98127|NCT00831389|Primary|Incidence of Nocturnal Hypoglycemia Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis||hypoglycemic events||Inter-Quartile Range|Median
98128|NCT00831389|Primary|Incidence of Hypoglycemia Immediately Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.|All subjects were used for final analysis||hypoglycemic events||Inter-Quartile Range|Median
98129|NCT00831389|Primary|Plasma Glucose (PG) Response to Exercise|PG at start of exercise minus the subsequent PG nadir|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis||mg/dL||Inter-Quartile Range|Median
98130|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.~Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.||Participants|||Number
98131|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intend-to-treat) population.||Participants|||Number
98132|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.||Participants|||Number
98133|NCT00831311|Primary|Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the Polio Antigens were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
98134|NCT00831311|Primary|Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the vaccine antigens were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
98135|NCT00831311|Primary|Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.~Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination."|Day 150 (1 month post-vaccination 3)|Seroprotection to the vaccine antigens was assessed in the per-protocol population.||Percentage of Participants|||Number
98136|NCT00831311|Primary|Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.|1 month post last vaccination|Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.||Percentage of Participants|||Number
98137|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.|Baseline to 12 weeks of treatment|FAS.||participants|||Number
98138|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).||participants|||Number
98328|NCT00829933|Secondary|Pharmacodynamic Parameters (PT, PT-INR, and APTT)|PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time|12 weeks||||||
99562|NCT00818779|Secondary|Serum Level of Intracellular Cell Adhesion Molecule||6 week||||||
98139|NCT00831233|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant’s QoL in relation to his urinary symptoms. The question was: ‘If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?’ The possible answers to this question ranged from ‘delighted’ (a score of ‘0’) to ‘terrible’ (a score of ‘6’). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.||score on scale||Standard Deviation|Mean
98140|NCT00831233|Secondary|Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.||percentage||Full Range|Median
98141|NCT00831233|Secondary|Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.||participants|||Number
98142|NCT00831233|Secondary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12|TRUS is a method of measuring the size of the prostate.|After 12 weeks treatment compared to Baseline|FAS, Observed Cases (OC).||mL||Standard Deviation|Mean
98143|NCT00831233|Secondary|Change From Baseline in Residual Volume (Vresidual) at Each Visit|Uroflowmetry was used to quantify the residual volume (Vresidual; mL)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.||mL||Standard Deviation|Mean
98144|NCT00831233|Secondary|Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit|Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.||mL/sec||Standard Deviation|Mean
98145|NCT00831233|Secondary|Change From Baseline in Total IPSS at Weeks 4 and 8|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4 and 8 weeks compared to Baseline|FAS, LOCF.||score on scale||Standard Deviation|Mean
98146|NCT00831233|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).||score on scale||Standard Deviation|Mean
98147|NCT00831129|Secondary|Change in Body Mass Index|change in body mass index between baseline and 6 month|Baseline and 6 months|||kg/m2||Standard Deviation|Mean
98148|NCT00831129|Secondary|Change in Adiponectin|change in Adiponectin between baseline and 6 month|Baseline and 6 months|||μg/ml||Standard Deviation|Mean
98149|NCT00831129|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance|change in homeostatic model assessment for insulin resistance between baseline and 6 month|Baseline and 6 months|||HOMA units||Standard Deviation|Mean
98150|NCT00831129|Secondary|Change in Insulin|change in Insulin between baseline and 6 month|Baseline and 6 months|||IU/ml||Standard Deviation|Mean
98151|NCT00831129|Secondary|Change in Fasting Blood Glucose|change in fasting blood glucose between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
98152|NCT00831129|Secondary|Change in Glycosylated Haemoglobin|change in glycosylated haemoglobin between baseline and 6 month|Baseline and 6 months|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
98153|NCT00831129|Secondary|Change in High-density Lipoprotein|change in high-density lipoprotein between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
98154|NCT00831129|Secondary|Change in Triglycerides|change in Triglycerides between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
98155|NCT00831129|Secondary|Change in Low-density Lipoprotein|change in low-density lipoprotein between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
98156|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure|change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
98157|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure|change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
98158|NCT00831129|Secondary|Change in Office Diastolic Blood Pressure|change in office diastolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
98159|NCT00831129|Secondary|Change in Office Systolic Blood Pressure|change in office systolic blood pressure between baseline and 6 month|Baseline and 6 months|||mm Hg||Standard Deviation|Mean
98160|NCT00831129|Secondary|Change in Malondialdehyde|change in Malondialdehyde between baseline and 6 month|Baseline and 6 months|||nM||Standard Deviation|Mean
98161|NCT00831129|Secondary|Change in Urinary Isoprostane|change in urinary isoprostane between baseline and 6 month|Baseline and 6 months|||ng/ml||Standard Deviation|Mean
98162|NCT00831129|Primary|Change in High-sensitivity C-reactive Protein|change in high-sensitivity C-reactive between baseline and 6 month|Baseline and 6 months|||mg/dl||Standard Deviation|Mean
98163|NCT00830960|Secondary|Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
99563|NCT00818779|Secondary|Serum Level of Vascular Cell Adhesion Molecule||6 week||||||
98164|NCT00830960|Secondary|Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary|"The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device.~Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM).~A higher value for change in PRU indicates a greater level of platelet inhibition."|Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase|"Pharmacodynamic analysis set is subset of FAS (≥1 genetics sample, ≥1 dose of study drug, ≥1 post-baseline PRU measurement, no significant protocol violations). Genetics subset LD population never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization.~Participants classified as EM or RM. Invalid measurements of PRU were excluded."||Change in PRU||Standard Deviation|Mean
98165|NCT00830960|Secondary|Inpatient Healthcare Resource Utilization|Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.|Initial hospitalization, 30 days, 90 days|As a consequence of the overall low number of reported clinical events, inpatient healthcare resource utilization data were not analyzed; thus zero participants were analyzed.||participants|||Number
98166|NCT00830960|Secondary|Incidence of CABG-related TIMI Major or Minor Bleeding.||Randomization through end of study (90 days)|"Safety Analysis Set (SAS): all randomized participants with at least 1 dose of study drug~In 10 participants, study drug discontinued due to planned CABG. 1 participant had CABG reported on revascularization case report form (CRF); no reports of CABG bleeding event"||participants|||Number
98167|NCT00830960|Secondary|Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding|"Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions.~Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline.~Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but <5 gm/dL from baseline.~Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed."|Randomization through end of study (90 days)|"Safety analysis set (SAS): all randomized participants with at least 1 dose of study drug~Two (2) participants had no event date; time from start of therapy to event was missing and thus they were not included in this table."||participants|||Number
98168|NCT00830960|Secondary|Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort|Risk was defined as the number of participants with events of all-cause death.|Randomization through end of study (90 days)|Full Analysis Set (FAS): all randomized subjects who received at least 1 dose of study drug||Participants|||Number
98169|NCT00830960|Secondary|Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition|"Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
98170|NCT00830960|Secondary|Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition|"Risk was defined as the number of participants with events of definite or probable stent thrombosis.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
98171|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
98172|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization|"Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization.~Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||Participants|||Number
98173|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR.~UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||Participants|||Number
98193|NCT00830804|Secondary|Number of Participants With Pretreatment Drug Resistance|Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.|At screening|All participants who started study treatment were included in the analysis.||participants|||Number
98174|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke.~CV death: death caused by CV event or not clearly attributable to non-CV causes.~Nonfatal MI: per adapted American College of Cardiology definition.~Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.||participants|||Number
98175|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort|"Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were <75 years).~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel."|At 30 days during MD therapy|"Per protocol set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event"||PRU||Standard Deviation|Mean
98176|NCT00830960|Secondary|Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort|"Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting >24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.~Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.~UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure"|Randomization through end of study (90 days)|"Full analysis set (FAS)~FAS: all randomized subjects who received at least 1 dose of study drug"||Participants|||Number
98177|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 days and at 90 days during MD therapy|"Per Protocol Set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event"||Percent inhibition|||Number
98178|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 minutes, 2 hours, and 4 hours following LD administration|Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event||Percent inhibition|||Number
98179|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|"Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.~Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel."|At 30 Days and 90 days during MD therapy|Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations in MD population: received percutaneous coronary intervention (PCI) for index event||PRU||Standard Deviation|Mean
98180|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.|"Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.~Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel."|At 30 minutes, 2 hours, and 4 hours following LD administration|"Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP)IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event"||PRU||Standard Deviation|Mean
98194|NCT00830804|Secondary|Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.|From start of study treatment to week 52|All participants who started study treatment were included in the analysis.||proportion of participants||95% Confidence Interval|Number
98181|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)|"ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.~Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase."|At 4 hours following LD administration|"Per Protocol Set (PPS) LD population~PPS: all randomized participants with ≥1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization and received percutaneous coronary intervention (PCI) for index event"||PRU||Standard Deviation|Mean
98182|NCT00830947|Primary|The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.||Time to Space Closure, an average of 22 weeks|||mm/week||Standard Deviation|Mean
98183|NCT00830804|Secondary|Plasma Trough Concentration of Darunavir|Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.||ng/ml||Inter-Quartile Range|Median
98184|NCT00830804|Secondary|Plasma Trough Concentration of Raltegravir|Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.||ng/ml||Inter-Quartile Range|Median
98185|NCT00830804|Secondary|Change in CD4 Count at Week 48|Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.|From start of study treatment through week 48|Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.||cells/mm3||Inter-Quartile Range|Median
98186|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
98187|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
98188|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
98189|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.||mg/dL||Inter-Quartile Range|Median
98190|NCT00830804|Secondary|Number of Participants With Perfect Overall Adherence by Self Report|"At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall perfect adherence."|From one week after starting study treatment to week 52|All participants who started study treatment were included in the analysis.||participants|||Number
98191|NCT00830804|Secondary|Number of Participants With Protease Drug Resistance at Virologic Failure|Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.||participants|||Number
98192|NCT00830804|Secondary|Number of Participants With Integrase Drug Resistance at Virologic Failure|Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.||participants|||Number
98329|NCT00829933|Secondary|Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment||12 weeks||||||
98195|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48|Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.|From start of study treatment to week 48|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.||proportion of participants||95% Confidence Interval|Number
98196|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24|Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.|From start of study treatment to week 24|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.||proportion of participants||95% Confidence Interval|Number
98197|NCT00830804|Secondary|Change in Plasma HIV-1 RNA From Baseline to Week 1|Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.|Baseline and week 1|Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.||log10 copies/ml||Inter-Quartile Range|Median
98198|NCT00830804|Secondary|Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24|The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to Week 24|All participants who started study treatment were included in the analysis.||Proportion of participants||95% Confidence Interval|Number
98199|NCT00830804|Primary|Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24|Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to week 24|All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.||Proportion of participants||95% Confidence Interval|Number
98200|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98201|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to < 50 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98202|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98203|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98204|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98205|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98206|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98330|NCT00829933|Secondary|Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.||12 weeks||||||
98207|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98208|NCT00830791|Secondary|Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.|||||
98209|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
98210|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||Standard Deviation|Geometric Mean
98211|NCT00830791|Secondary|Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||Standard Deviation|Geometric Mean
98212|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
98213|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||95% Confidence Interval|Geometric Mean
98214|NCT00830791|Secondary|Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose|||Hours||95% Confidence Interval|Geometric Mean
98215|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
98216|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||nM||95% Confidence Interval|Geometric Mean
98217|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.|||||
98218|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose|||nM per Hour||95% Confidence Interval|Geometric Mean
98219|NCT00830791|Primary|Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of > 50 to 80 mL/min/1.73m^2.|72 Hours Post-Dose|||nM per Hour||95% Confidence Interval|Geometric Mean
98220|NCT00830791|Secondary|Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose|||nM||95% Confidence Interval|Geometric Mean
98221|NCT00830765|Primary|Weeks Gestation at Birth Among Patients Receiving the Active Drug.|Weeks gestation at birth, the interval to delivery, or neonatal morbitity.|Through delivery, until discharge up to 40 weeks gestation|Intention to treat analysis in both groups||weeks||Standard Deviation|Mean
98222|NCT00830388|Secondary|To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.|Adverse events were used to assess safety.|4 weeks|||events|||Number
98223|NCT00830388|Primary|The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor|Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.|4 weeks|||participants|||Number
98224|NCT00830375|Primary|Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)|The CB-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). Scores ranging from 0 to 10 reflect minimal or mild symptoms; scores from 11 to 20 suggest moderate symptoms; severe symptoms are associated with scores from 21 to 30; and scores greater than 30 reflect extreme buying symptoms|from study start to study end (8-weeks) and is Investigator rated|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
98225|NCT00830362|Primary|Single Item Craving Test Session Difference Scores|Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.|Both days of cue exposure|||units on a scale||Standard Error|Mean
98226|NCT00830336|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.||ng*h/mL||Standard Deviation|Mean
98227|NCT00830336|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.||ng*h/mL||Standard Deviation|Mean
98228|NCT00830336|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.||ng/mL||Standard Deviation|Mean
98229|NCT00830310|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
98230|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week)|"Treatment nonadherence is measured as a percentage of medications not taken within the past week at time of assessment.~The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||percentage of medications not taken||Standard Error|Mean
98231|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
98232|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
98233|NCT00830310|Secondary|Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
98234|NCT00830310|Secondary|Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)|The minimum score is 0 and the maximum score is 10. A higher score implies a better attitude.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
98235|NCT00830310|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
98236|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
98377|NCT00829426|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period|||ng*h/mL||Standard Deviation|Mean
98237|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)|"Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment.~The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.||percentage of medication not taken||Standard Error|Mean
98238|NCT00830284|Secondary|Safety - Airleak, Cardiac Compromise, Respiratory Acidosis.||4 hours|||Participants|||Count of Participants
98239|NCT00830284|Primary|PaO2 + PaCO2 of 400 or Higher.||2 hours|||Participants|||Count of Participants
98240|NCT00830258|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98241|NCT00830258|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98242|NCT00830258|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
98243|NCT00830232|Secondary|Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI||within 24 hours after carotid artery stenting||||||
98244|NCT00830232|Secondary|Composite of Any Stroke, Myocardial Infarction or Death||within 30 days after the carotid stenting procedure||||||
98245|NCT00830232|Primary|Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.|Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.|First 24 hours after implantation of carotid stent|||Micro-emboli||Inter-Quartile Range|Median
98246|NCT00830219|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98247|NCT00830219|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98248|NCT00830219|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98249|NCT00830206|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.||ng*h/mL||Standard Deviation|Mean
98250|NCT00830206|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.||ng*h/mL||Standard Deviation|Mean
98251|NCT00830206|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.||ng/mL||Standard Deviation|Mean
98252|NCT00830167|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98253|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98254|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98304|NCT00830115|Secondary|Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 887~Day 1 = 867~Day 2 = 846~Day 3 = 823~Day 4 = 801~Day 5 = 784~Day 6 = 773"||Units on a scale||Standard Deviation|Mean
98255|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98256|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98257|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98258|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98259|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98260|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98261|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98262|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98263|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98264|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98265|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98266|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98267|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98268|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98269|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98270|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98271|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98272|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98273|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98274|NCT00830167|Secondary|Change From Baseline in Sleep Quality Score at Endpoint|Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98275|NCT00830167|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Participants|||Number
98276|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98277|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98278|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98279|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98280|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98281|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98305|NCT00830115|Secondary|Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 903~Day 1 = 891~Day 2 = 877~Day 3 = 843~Day 4 = 823~Day 5 = 791~Day 6 = 781"||Units on a scale||Standard Deviation|Mean
98282|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98283|NCT00830167|Secondary|Percentage of Participants Who Was Categorized as “Improved (Very Much Improved, Much Improved, or a Minimally Improved)” According to the Patient Global Impressions of Change (PGIC)|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication.||Percentage of participants|||Number
98284|NCT00830167|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.||Scores on a scale||Standard Error|Least Squares Mean
98285|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98286|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98287|NCT00830128|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Paticipants|||Number
98288|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98289|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98290|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||hours||Standard Deviation|Mean
98306|NCT00830115|Secondary|Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 908~Day 1 = 906~Day 2 = 890~Day 3 = 876~Day 4 = 861~Day 5 = 842~Day 6 = 834"||Units on a scale||Standard Deviation|Mean
98291|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98292|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98293|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98294|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
98295|NCT00830128|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|"The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment.||mm||Standard Deviation|Mean
98296|NCT00830128|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Up to 53 weeks|All participants who received at least 1 dose of the study medication.||Participants|||Number
98297|NCT00830115|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Participants|||Number
98298|NCT00830115|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Participants|||Number
98299|NCT00830115|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
98300|NCT00830115|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
98301|NCT00830115|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
98302|NCT00830115|Secondary|Patient's Assessment of Nausea for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 809~Day 1 = 798~Day 2 = 776~Day 3 = 761~Day 4 = 743~Day 5 = 738~Day 6 = 732"||Units on a scale||Standard Deviation|Mean
98303|NCT00830115|Secondary|Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 798~Day 1 = 782~Day 2 = 769~Day 3 = 759~Day 4 = 752~Day 5 = 739~Day 6 = 738"||Units on a scale||Standard Deviation|Mean
98310|NCT00830076|Secondary|Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations|Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2|||mg/dL||95% Confidence Interval|Least Squares Mean
98311|NCT00830076|Secondary|β-cell Sensitivity|"β-cell sensitivity was defined as the incremental post-prandial~4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC."|6 hour post-dose (4 hour postmeal) on Day 2|Beta-cell sensitivity was not calculated for 1 participant following the administration of sitagliptin alone and metformin alone due to missing insulin data.||(ng/min)/(mg/dL)*10^ -3||95% Confidence Interval|Least Squares Mean
98312|NCT00830076|Primary|Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations|Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2|||picomolar||95% Confidence Interval|Least Squares Mean
98313|NCT00830037|Secondary|Proteinuria|Proteinuria was estimated using measurements of urinary protein and creatinine before iron administration at baseline and at periodic intervals thereafter. Mean change from baseline log urinary protein/creatinine ratio (g/g) is reported at 2 years.|Baseline, 2 years|||g/g||95% Confidence Interval|Mean
98314|NCT00830037|Primary|Mean Rate of Decline in mGFR in the Two Groups - Oral and IV Iron|Plasma clearance of iothalamate was measured by administering an IV bolus of 5 mL of iothalamate meglumine and sampling 2 mL of blood at 0, 5, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, and 300 min after injection. Iothalamate was measured by high-performance liquid chromatography. Plasma clearance was calculated using a two-pool model using validated pharmacokinetic software. The mean modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) in each group (IV iron vs. oral iron) was then calculated after adjustment for baseline log urinary protein/creatinine ratio.|Baseline, 2 years|Modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) was calculated for each group (IV iron vs. oral iron) after adjustment for baseline log urinary protein/creatinine ratio.||Slope (ml/min per 1.73m2 per year)|||Number
98315|NCT00830024|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98316|NCT00830024|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98317|NCT00830024|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
98318|NCT00829998|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98319|NCT00829998|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98320|NCT00829998|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
98321|NCT00829985|Secondary|Percent of Participants With the Occurrence of Adverse Events (AE)|Percent of participants who experienced at least one adverse event|Participant enrollment to end of study (up to 6 months post-baseline)|Safety population||percentage of population|||Number
98322|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 60 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Percent antibody binding||95% Confidence Interval|Mean
98323|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 30 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Percent antibody binding||95% Confidence Interval|Mean
98324|NCT00829985|Secondary|Difference in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. This ratio is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Geometric Mean
98325|NCT00829985|Primary|Difference in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat||Ratio||95% Confidence Interval|Geometric Mean
98326|NCT00829933|Secondary|Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )||12 weeks||||||
98327|NCT00829933|Secondary|Plasma DU-176 Concentration||12 weeks||||||
98331|NCT00829933|Primary|Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.|The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.|12 weeks|Primary endpoint analyzed for subjects who proceeded to treatment period in FAS.||percent of subjects with bleeding event||95% Confidence Interval|Number
98332|NCT00829868|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98333|NCT00829868|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98334|NCT00829868|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
98335|NCT00829790|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
98336|NCT00829790|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
98337|NCT00829790|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
98338|NCT00829764|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
98339|NCT00829764|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng*h/mL||Standard Deviation|Mean
98340|NCT00829764|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||ng/mL||Standard Deviation|Mean
98341|NCT00829738|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
98342|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
98343|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Constipation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98344|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98345|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98346|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
98347|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98348|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98349|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98350|NCT00829738|Primary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
98351|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98352|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98353|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
98354|NCT00829712|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98355|NCT00829712|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98356|NCT00829712|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98357|NCT00829686|Secondary|Recurrence Rates|recurrence of abscess in previous or new location within 30 days|30 days|||participants|||Number
98358|NCT00829686|Primary|Clinical Improvement at 7 Days After Incision and Drainage|improving wound without evidence of fever, worsening cellulitis or induration|7 days|||participants|||Number
98359|NCT00829673|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98360|NCT00829673|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98361|NCT00829673|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98362|NCT00829621|Primary|Presence of BMP-2 in Effluent Collected in IVAC Canister|Presence of BMP-2 in effluent collected in IVAC canister|12-hours, 24-hours, 36-hours, and 48-hours after IVAC application|||participants|||Number
98363|NCT00829530|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)for Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98364|NCT00829530|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98365|NCT00829530|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98366|NCT00829530|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98367|NCT00829530|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98368|NCT00829504|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98369|NCT00829504|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98370|NCT00829504|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98371|NCT00829452|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours) for Ramiprilat.|Informational comparison of AUc0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98372|NCT00829452|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98373|NCT00829452|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98374|NCT00829452|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98375|NCT00829452|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98376|NCT00829439|Primary|Maximum Dose of Levodopa/Carbidopa That Can be Tolerated (Without Any Dose Limiting Toxicity) by at Least 3 Subjects.||1 week|||mg/kg/day|||Number
98380|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 36 weeks post-baseline comparing CBT to Education.~0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed"|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36 week post treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
98381|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 36 weeks post-baseline comparing CBT to Education.~Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
98382|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms~Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
98383|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 12 weeks post-baseline combaring CBT and ED.~0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment; making the number of participants analyzed differant than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
98384|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 12 weeks post-baseline comparing CBT to Education.~Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment data; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
98385|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms~Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that completed baseline data completed 12 week post treatment assessments; making the number of participants analyzed different than reported for baseline data only.||units on a scale||95% Confidence Interval|Mean
98386|NCT00829309|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng*h/mL||Standard Deviation|Mean
98387|NCT00829309|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one subject could not be included in the AUC0-inf calculation for Pravachol®.||ng*h/mL||Standard Deviation|Mean
98388|NCT00829309|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.||ng/mL||Standard Deviation|Mean
98389|NCT00829296|Secondary|Change in Pulse Pressure Amplification|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure).|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||ratio||Standard Deviation|Mean
98390|NCT00829296|Secondary|Change in Augmentation Index|Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||percent (%)||Standard Deviation|Mean
98391|NCT00829296|Secondary|Change in Pulse Wave Velocity (PWV)|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||m/s||Standard Deviation|Mean
98473|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98392|NCT00829296|Primary|Change in Central Systolic Blood Pressure (SBP)|Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.||mmHg||Standard Deviation|Mean
98393|NCT00829283|Secondary|BMI|The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.|12 months follow-up post-treatment|||kg/m^2||Standard Deviation|Mean
98394|NCT00829283|Primary|Number of Subjects Who Reached Binge Eating Remission|Binge Remission (abstinence from binge eating)|12 months follow-up|||participants|||Number
98395|NCT00829244|Secondary|Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome|Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).|up to 9 month (following the end of treatment)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||participants|||Number
98396|NCT00829244|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment until Day 15-20 Post-hCG|Safety population included all the participants who were randomized.||participants|||Number
98397|NCT00829244|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||percentage of participants|||Number
98398|NCT00829244|Secondary|Serum Progesterone (P4) Levels||End of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||nmol/L||Standard Deviation|Mean
98399|NCT00829244|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as 2 or more fetal hearts with activity.|Day 35-42 Post-hCG|The modified ITT population. Number of participants analyzed (N) signifies those participants who were evaluated for this outcome measure.||participants|||Number
98400|NCT00829244|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||percent sacs per embryo||Standard Deviation|Mean
98401|NCT00829244|Secondary|Number of Participants With Fetal Sacs and Fetal Hearts|Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||participants|||Number
98402|NCT00829244|Secondary|Percentage of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.|Start of treatment until Day 15-20 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||percentage of participants|||Number
98403|NCT00829244|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment|Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.|Start of treatment until Day 15-20 post-hCG|All the randomized participants were analyzed for this outcome measure (N=200).||Participants|||Number
98404|NCT00829244|Secondary|Total Number of GONAL-f® Stimulation Treatment Days||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||days||Standard Deviation|Mean
98405|NCT00829244|Secondary|Mean GONAL-f® Daily Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||IU||Standard Deviation|Mean
98406|NCT00829244|Secondary|Total GONAL-f® Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||IU||Standard Deviation|Mean
98407|NCT00829244|Primary|Number of Oocytes Retrieved Per Participant|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)|The modified Intention-To-Treat (ITT) population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.||oocytes||Standard Deviation|Mean
98408|NCT00829179|Primary|Change in Exhaled Nitric Oxide From Baseline to Week 12|The primary outcome measure was the change in exhaled nitric oxide levels between baseline and week 12. 12 week value minus baseline value. (Baseline was -1 week, ie 1 week prior to the start of study drug)|13 weeks|||parts per billion (ppb)||Standard Deviation|Mean
98409|NCT00829166|Secondary|Time to Symptom Progression|"Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.||Months||95% Confidence Interval|Median
98410|NCT00829166|Secondary|Percentage of Participants With Symptom Progression|"Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.||percentage of participants|||Number
98411|NCT00829166|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
98412|NCT00829166|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
98413|NCT00829166|Secondary|Percentage of Participants With Clinical Benefit as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
98423|NCT00829166|Primary|Percentage of Participants Who Died: Second Interim Analysis|The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
98414|NCT00829166|Secondary|Duration of Objective Response (DOR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
98415|NCT00829166|Secondary|Percentage of Participants With Objective Response (OR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
98416|NCT00829166|Secondary|PFS as Assessed by the Investigator|Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
98417|NCT00829166|Secondary|Percentage of Participants With PD or Death as Assessed by the Investigator|PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
98418|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 2|2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.|Year 2|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants||95% Confidence Interval|Number
98419|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 1|1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.|Year 1|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants||95% Confidence Interval|Number
98420|NCT00829166|Primary|Overall Survival: Final Analysis|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
98421|NCT00829166|Primary|Percentage of Participants Who Died: Final Analysis|The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
98422|NCT00829166|Primary|Overall Survival: Second Interim Analysis (Co-primary Endpoint)|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
98680|NCT00827099|Secondary|Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.|Patients will be evaluated regularly for the development of graft versus host disease both acute & chronic.|Day 30|This study was terminated early. No participants were analyzed.||participants|||Number
98424|NCT00829166|Primary|Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)|Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||Months||95% Confidence Interval|Median
98425|NCT00829166|Primary|Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)|PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.||percentage of participants|||Number
98426|NCT00829049|Secondary|Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16|Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percent Change||Full Range|Median
98427|NCT00829049|Secondary|Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12|Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.|Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percentage of patients|||Number
98428|NCT00829049|Secondary|Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16|Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.|Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percentage of patients|||Number
98429|NCT00829049|Primary|Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).|Baseline, Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.||Percent Change||Full Range|Median
98430|NCT00829036|Primary|Mean Percent (Prototype / Baseline) Time|The outcome measure for each subject is the mean of the (Prototype Time / Baseline Time) across 12 trials. The outcome measure for the experiment is the mean of 24 individual subject mean scores. This mean outcome measure is expressed as a percentage of the mean Baseline Time, where improved performance is represented by a percentage that is less than 100 percent of the Baseline Time. The lower the percentage, the better the performance improvement.|2 hours|Power Analysis: Using Repeated Measures ANOVA for the 24 participants assuming a minimum correlation between repeated measures of .7, we chose our analyses will be sensitive to a medium between factor effect size of f=.33 with power set to .80 and alpha level set to .05.||Percentage of Baseline Performance Time||Standard Deviation|Mean
98431|NCT00829010|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
98469|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants|||Number
98432|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post Synflorix booster vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
98433|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post-primary vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.||Subjects|||Number
98434|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:~drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
98435|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
98436|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:~drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
98437|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.||Subjects|||Number
98438|NCT00829010|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs|Acquisition of new H. influenza* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented||Subjects|||Number
98439|NCT00829010|Secondary|Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.|Positive cultures of H. influenza* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented||Swabs|||Number
98440|NCT00829010|Secondary|Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples|Salivary antibodies against selected common bacterial protein antigens. Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva. Salivary samples were sent to RMPRU (or GSK Biologicals’ designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C. The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented||U/mL||95% Confidence Interval|Geometric Mean
99233|NCT00822328|Secondary|Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.~Bacterial colonies were cultured and counted."|at week 0, 1, 2, 3, 4, 5, 6||03/2009||||
98441|NCT00829010|Secondary|Concentrations of Antibodies Against Measles|Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.|1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
98442|NCT00829010|Secondary|Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.|Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL). The cut-off of the assay is 20 U/mL. Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.|1 month after the administration of the second vaccine dose (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||U/mL||95% Confidence Interval|Geometric Mean
98443|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.|"Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL.~As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||mIU/mL||95% Confidence Interval|Geometric Mean
98444|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA|"Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL.~As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month following primary immunization (at Month 3)|According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
98445|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month after the booster vaccination (at Month 15)|The ATP cohort for immunogenicity at 15 -18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||µg/mL||95% Confidence Interval|Geometric Mean
98446|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
98447|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicityat 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||EL.U/mL||95% Confidence Interval|Geometric Mean
98448|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
98449|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL). The cut-off of the assay is 0.1IU/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The According-To-Protocol cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.||IU/mL||95% Confidence Interval|Geometric Mean
98450|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
99329|NCT00819156|Secondary|Days to 50 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population||days||Full Range|Median
98451|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
98452|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
98453|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
98454|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|ATP cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
98455|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
98456|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
98457|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
98470|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants|||Number
98471|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98458|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
98459|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
98460|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||µg/ml||95% Confidence Interval|Geometric Mean
98461|NCT00829010|Primary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.||Subjects|||Number
98462|NCT00828984|Secondary|Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
98463|NCT00828984|Secondary|Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
98464|NCT00828984|Secondary|To Determine the Effect of PEG 3350 on Mucosal Apoptosis (Cleaved Caspase-3)|Change in activated caspase-3 (apoptosis) expression as measured in endoscopically normal (non-ACF) mucosal biopsies|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
98465|NCT00828984|Secondary|Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on mucosal epithelial proliferation (Ki-67)|6 months - baseline|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups.||ng/ml||Standard Deviation|Mean
98466|NCT00828984|Secondary|Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||Aberrant Crypt Foci||Standard Deviation|Mean
98467|NCT00828984|Primary|Difference (After Treatment Minus Before Treatment) of EGFR Expression|Evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8g or 17g/day for six months) versus placebo on EGFR expression.|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).||ng/ml||Standard Deviation|Mean
98468|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants|||Number
98472|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98474|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98475|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98476|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98477|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12|Participants with “Yes” response to a question which stated “The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?”.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98478|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12|Participants with “Yes” response to a question which stated “The self-test have increased my motivation for taking my medication for hyperlipidemia?”. The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.|Month 12|The Full Analysis Set (FAS) included all enrolled participants who met all inclusion criteria.||Percentage of participants||95% Confidence Interval|Number
98479|NCT00828841|Secondary|Overall Survival by Histology||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Subjects were stratified by histology prior to randomization to a treatment arm.||Months||95% Confidence Interval|Median
98480|NCT00828841|Secondary|1-year Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|||percentage of participants||95% Confidence Interval|Number
98481|NCT00828841|Primary|Overall Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Two subjects in Arm A were censored due to negative event intervals.||Months||95% Confidence Interval|Median
98482|NCT00828750|Secondary|Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy|Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS||percentage of participants|||Number
98483|NCT00828750|Secondary|Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication|Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis.||percentage of participants|||Number
98484|NCT00828750|Secondary|Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication|Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants.||percentage of participants|||Number
98485|NCT00828750|Secondary|Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals|Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)|FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants.||weeks||Full Range|Median
98486|NCT00828750|Secondary|Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)|Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants.||percentage of participants|||Number
98487|NCT00828750|Secondary|Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.||Gi/L||Full Range|Median
98500|NCT00828568|Primary|Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%|"Uses per protocol (PP) population.~Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Per Protocol (PP) population||Participants|||Number
98488|NCT00828750|Secondary|Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.||percentage of participants|||Number
98489|NCT00828750|Primary|Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|Safety Population (SP): all participants who received at least one dose of study medication||participants|||Number
98490|NCT00828711|Secondary|Time to Onset of Active Labor||Interval from study drug administration to active labor (average 12 hours)|Kaplan-Meier Estimates for Time to Onset of Active Labor presented (Modified Intention-to-Treat population). Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery (Censored subjects = MVI 100: 5; MVI 150: 7; MVI 200: 8)||minutes||95% Confidence Interval|Median
98491|NCT00828711|Secondary|Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.|From study drug insertion up to 2 hours post study drug removal|The plan was to enrol 24 subjects to the pharmacokinetic (PK) arm of the study. Only 3 subjects enrolled in the PK arm; there were too few subjects and too few samples available. Due to insufficient data, no statistical analysis was possible. Only misoprostol acid levels for each blood sampling timepoint for each subject was determined.||PK Parameters|||Number
98492|NCT00828711|Secondary|Use of Oxytocin|Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.|At least 30 minutes after study drug removal|Percentage of subjects who required pre-delivery oxytocin is presented (Modified Intention-to-Treat population).||percentage of participants||95% Confidence Interval|Number
98493|NCT00828711|Secondary|Cervical Ripening Using Composite Measure of Success|"Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration:~Increase from baseline in modified Bishop score ≥3; or~Achievement of modified Bishop score of ≥6; or~Vaginal delivery."|12 hours after insertion of drug|Percentage of subjects with cervical ripening success at 12 hours is presented (Modified Intention-to-Treat population).||percentage of participants||95% Confidence Interval|Number
98494|NCT00828711|Secondary|Proportion of Cesarean Delivery||Interval from study drug administration to cesarean delivery (average 24 hours)|Percentage of subjects who had a cesarean delivery during the first hospitalization (safety population) is presented.||percentage of participants||95% Confidence Interval|Number
98495|NCT00828711|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48 - 72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.||percentage of participants|||Number
98496|NCT00828711|Secondary|Time to Vaginal Delivery||Interval from study drug administration to delivery (average 24 hours)|Kaplan-Meier Estimates are based on Modified Intention-to-Treat (MITT) population.Subjects who had a cesarean, discharged prior to delivery or withdrew consent during first hospitalization were censored (MVI 100: 37, MVI 150: 39, MVI 200: 31) using the longest time interval from study drug administration to cesarean or to Labor & Delivery discharge||minutes||95% Confidence Interval|Median
98497|NCT00828711|Primary|Proportion of Women Delivering Vaginally||Interval from study drug administration to 24 hours|Analysis based on Modified Intention-to-Treat (MITT) population who delivered vaginally. Percentage of subjects who delivered vaginally is presented.||percentage of participants||95% Confidence Interval|Number
98498|NCT00828568|Primary|Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline|"Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis.~Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Intention to Treat (ITT) Population||Participants|||Number
98499|NCT00828568|Secondary|Patients Reporting at Least One Adverse Event|For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.|24 weeks|Safety group includes all patients who received a single dose||Participants|||Number
98589|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
98590|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
98501|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before the 13th acupuncture treatment|This was the number of participants who continued to, and completed, Series 2 of the treatments||units on a scale||Standard Deviation|Mean
98502|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before 7th acupuncture treatment|All participants completing 6 acupuncture treatments were analysed||units on a scale||Standard Deviation|Mean
98503|NCT00828464|Secondary|Change in Subject’s Visual Analogue Assessment Scale From Baseline to Day 15|Mean change in subject’s visual analogue assessment scale from baseline to day 15. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 15|ITT||Units on a scale||Standard Deviation|Mean
98504|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI)for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
98505|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
98506|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
98507|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
98508|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 15 with at least a 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
98509|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Palm of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
98510|NCT00828464|Secondary|Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
98591|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
98511|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers|"Proportion of Subjects at day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
98512|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT||Percentage of Participants|||Number
98513|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of subjects at day 15 with at least 1-Grade improvement in the Hand Eczema Severity Index Score (HESI) for all symptoms present at baseline - Finger Tips. The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT||Percentage of Participants|||Number
98514|NCT00828464|Secondary|Change in Subject’s Visual Analogue Assessment Scale|Mean change in subject’s visual analogue assessment scale from baseline to day 8. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 8|ITT. Twenty-nine of the 30 subjects enrolled on this study had results for this endpoint on day 8. Thirty of the 30 subjects enrolled had results for this same assessment at the day 15 visit.||Units on a scale||Standard Deviation|Mean
98515|NCT00828464|Primary|Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score|"Proportion of Subjects with at least a 1-Grade Improvement from Baseline to Day 15 In Investigator's Static Global Assessment Score (ISGA) - Chronic Hand Dermatitis Please note that the proportion of participants is being reported as a percentage of participants.~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 15|Intent-to-treat (ITT).||Percentage of Participants|||Number
98516|NCT00828464|Secondary|Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.|"Please note that the proportion of participants is being reported as a percentage of participants.~Investigator's Static Global Assessment Score (ISGA) At least 1-grade improvement (%) at Day 8~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 8|ITT||Percentage of Participants|||Number
98517|NCT00828412|Primary|Change From Baseline in Three Item Severity Score|The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.|Baseline to 6 weeks|All subjects with data were included in the analysis. No imputation was done for missing data.||units on a scale||Standard Deviation|Mean
98518|NCT00828347|Primary|Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level||Participants were followed for 24 weeks|||participants|||Number
98519|NCT00828321|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time 72 Hours)of Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98520|NCT00828321|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98521|NCT00828321|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)of Ramipril.|Bioequivalence based on AUC0-t for Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98522|NCT00828321|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)of Ramipril|Bioequivalence based on AUC0-t of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg*h/mL||Standard Deviation|Mean
98523|NCT00828321|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril|Bioequivalence based on Cmax of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.||pg/mL||Standard Deviation|Mean
98524|NCT00828308|Primary|Prostate-Specific Antigen (PSA) Response|Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone|after 12 weeks of ixabepilone|||participants|||Number
98525|NCT00828295|Secondary|Proportion of Patients With Complete Response 0-24 Hours|Complete Response defined as no vomiting, no retching, and no use of rescue medication|0-24 hours|Full Analysis Set||percentage of patients||95% Confidence Interval|Number
98526|NCT00828295|Primary|Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively||0-72 hours post-operatively|The Full Analysis Set (FAS) included all randomized patients, who received the study drug, had general anesthesia and surgery. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the treatment to which they were randomized.||percentage of patients||95% Confidence Interval|Number
98527|NCT00828204|Other Pre-specified|Mean Pain Score After Injection|Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).|Day 1, Day 8, Day 15, Day 22|Participants in the Main and Initial Subsets who received at least 1 dose of Avonex injection using the Avonex single-use autoinjector. Missing data were not imputed.||scores on a scale||Standard Deviation|Mean
98528|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe|Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?|Day 23|Participants who received at least 1 injection with autoinjector and had a complete questionnaire. Missing data were not imputed.||percentage of participants|||Number
98529|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector|"Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: Did you have any difficulty with your injection? The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented."|Day 1, Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex single-use autoinjector and submitted an assessment of injection procedure form. Missing data were not imputed. n=number of participants with assessment at the given timepoint.||percentage of participants|||Number
98530|NCT00828204|Other Pre-specified|Mean Score for Initial Subset on Autoinjector Instructions Grading Scale|"Participants in the Initial Subset were asked to answer the question How satisfied are you with the presentation of the autoinjector instructions? on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied)."|Day 8|Participants in the Initial Subset who received at least one injection with the Avonex single-use autoinjector and completed the grading scale.||scores on a scale||Standard Deviation|Mean
98531|NCT00828204|Other Pre-specified|Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective|Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.|Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex Single-use Autoinjector and submitted an assessment form. n=the number of subjects completing the assessment form at the given timepoint. Missing data were not imputed.||percentage of participants|||Number
98532|NCT00828204|Other Pre-specified|Mean Score for Ease of Use Grading Scale|Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).|Day 1, Day 8, Day 15, Day 22|Participants who received at least one injection with the Avonex Single-use Autoinjector. Missing data were not imputed. n=number of participants who received an injection and had an assessment at the given timepoint.||scores on a scale||Standard Deviation|Mean
98533|NCT00828204|Other Pre-specified|Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector|The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.|Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)|Participants who received at least one injection with the Avonex single-use autoinjector. Missing data were not imputed.||percentage of participants|||Number
98534|NCT00828204|Other Pre-specified|Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector|"Number of participants in the Initial Subset who answered yes to the question Were you satisfied with this single-use injector? on the Subject Satisfaction Questionnaire."|Day 23|Participants in the Initial Subset who received at least 1 injection with autoinjector who had a complete Subject Satisfaction Questionnaire.||participants|||Number
98535|NCT00828204|Primary|Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector|A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.|Day 22|Participants in the Main Subset who received an injection of Avonex prefilled syringe as a manual IM injection, at least 1 injection of Avonex prefilled syringe using the autoinjector, and had a completed Observation Form were included in the analysis. Missing data were not imputed. All analyses are based on observed data.||percentage of participants||95% Confidence Interval|Number
98536|NCT00828191|Secondary|Delivery Rate||nearly 9 months after treatment start|All randomized patients||percentage of randomized patients|||Number
98537|NCT00828191|Secondary|Implantation Rate|Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.|4-5 weeks after treatment start|Patient who had at least one embryo transferred.||percentage of embryos transferred||Standard Deviation|Mean
98538|NCT00828191|Primary|Ongoing Pregnancy Rate||10 weeks after treatment start|All randomized patients were included in the analysis||percentage of randomized patients|||Number
98539|NCT00828178|Secondary|Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.|The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.|pre-treatment(baseline) and post-treatment (after 12 weeks)|||ng/ml||Standard Deviation|Mean
98592|NCT00827827|Primary|Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months||lbs||Standard Error|Mean
98540|NCT00828178|Secondary|Effect of Omega-3 Versus Placebo on Disease Activity in SLE.|"The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks).~SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score.~PGA - range 0-3, high score indicates high disease activity."|pre-treatment(baseline) and post-treatment (after 12 weeks)|||Units on a scale||Standard Deviation|Mean
98541|NCT00828178|Primary|Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.|The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).|12 weeks|Patients who successfully completed the trial.||cm||Standard Deviation|Mean
98542|NCT00828139|Secondary|Individual Toxicity Proportions as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|This outcome is the same as the result listed in Results Adverse Events|Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.||||||
98543|NCT00828139|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Ant CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
98544|NCT00828139|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)|"The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Disease assessment for response were performed every 6 weeks, up to 2 years.|||proportion of participants||90% Confidence Interval|Number
98545|NCT00828139|Secondary|Overall Survival|Estimated to within at least 15% (95% confidence interval).|Weekly, up to 2 years.|||months||90% Confidence Interval|Median
98546|NCT00828139|Primary|Progression-free Survival (PFS)|"From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.~Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration."|Disease assessments were performed every 6 weeks, up to 2 years.|||Months||90% Confidence Interval|Median
98547|NCT00828113|Primary|Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52|Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52|7-day point prevalence|Participants randomized at 12 weeks who continued in the study to Week 52 and provided CO-verified smoking status.||participants|||Number
98548|NCT00828061|Secondary|Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils|Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients with Slide Quality ≤ 3 (Slide Quality measured on a 6 point scale with values > 3 indicating a level of debris that interferes with cell typing and counting).||Percentage of cells that are eosinophils||95% Confidence Interval|Least Squares Mean
98549|NCT00828061|Primary|Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration|Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients as Treated||Fold Change||95% Confidence Interval|Geometric Mean
98550|NCT00827983|Secondary|Implantation Rate|Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.|Four to five weeks after oocytes retrieval|All the patients who had at least one embryo transferred||percentage of embryos transferred||Standard Deviation|Mean
98551|NCT00827983|Secondary|Delivery Rate and Live Birth Rate||nearly 9 month after treatment start|all the randomised patients were included in the analysis||percentage of randomised patients|||Number
98552|NCT00827983|Primary|Ongoing Pregnancy Rate at the End of the Study||10 weeks after treatment start|ITT population was analysed (i.e. all the randomised patients)||percentage of randomized patient|||Number
98553|NCT00827944|Secondary|Other Post-operative Complications||M12 after surgery|As Treated population||participants|||Number
98554|NCT00827944|Secondary|Return to Work and to Normal Daily Activities||Effective date|The analysis were performed on an As Treated (AT) population, with a 5% significance level.||days||Standard Error|Mean
98555|NCT00827944|Secondary|Wound Complications and Hernia Recurrences||M12 after surgery|The analysis were performed on an As Treated (AT) population, with a 5% significance level.||participants|||Number
98556|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)|Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).|M3, M12 after surgery|The analysis were performed on an As Treated population (AT), with a 5% significance level.||units on a scale||Standard Deviation|Mean
98593|NCT00827632|Secondary|Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.||24 hours during week 3 of follow-up cycle||||||
98557|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)|Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|M3, M12 after surgery|The analysis were performed on an As Treated (AT)population, with a 5% significance level.||units on a scale||Standard Deviation|Mean
98558|NCT00827944|Secondary|Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score|Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|3 months after surgery|||participants|||Number
98559|NCT00827944|Secondary|Foreign Body Sensation|Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.|M1, M3, M12 months after surgery|The analysis were performed on an As Treated population, with a 5% significance level.||participants|||Number
98560|NCT00827931|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||Participants|||Number
98561|NCT00827931|Secondary|Hemoglobin Levels||End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||Gram/Deciliter (g/dL)||Standard Deviation|Mean
98562|NCT00827931|Secondary|Percentage of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dL) hemoglobin or hematocrit value of 24 percent.|Up to Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||Percentage of participants||95% Confidence Interval|Number
98563|NCT00827931|Secondary|Total Blood Loss as Assessed by the Gross’ Formula|Gross’ formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||mL||Standard Deviation|Mean
98564|NCT00827931|Secondary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||mL||Standard Deviation|Mean
98565|NCT00827931|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||mL||Standard Deviation|Mean
98566|NCT00827931|Primary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Post-operation, Day 1, Day 2 up to drain removal|Full Analysis Set (FAS) population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.||milliliter (mL)||Standard Deviation|Mean
98567|NCT00827918|Secondary|Mean Change From Baseline in PANSS Negative Subscale at Week 4|PANSS Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms. The Negative scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS negative subscale measurements between baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
98568|NCT00827918|Secondary|Mean Change From Baseline in PANSS Positive Subscale at Week 4|PANSS Positive scale assesses hallucinations, delusions and related symptoms. The Positive scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS positive subscale measurements between baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
98569|NCT00827918|Secondary|Mean Change From Baseline in Clinical Global Impression – Severity of Illness Scale (CGI-S) at Week 4|CGI-S is a commonly used measure of symptom severity in treatment studies of participants with mental disorders. CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.|Baseline and Week 4|Randomized participants with any CGI-S measurements between baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
98570|NCT00827918|Secondary|Percentage of Participants With Response at Week 4|Responders were defined as participants who demonstrated ≥ 20% improvement from baseline on the PANSS total score. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Week 4|Randomized participants with a PANSS measurement at Week 4.||Percentage of participants|||Number
98571|NCT00827918|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 4 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.||Participants|||Number
98572|NCT00827918|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 6 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.||Participants|||Number
98573|NCT00827918|Primary|Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) at Week 4|PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Baseline and Week 4|Randomized participants with any PANSS measurements between Baseline and Week 4.||Units on a scale||95% Confidence Interval|Least Squares Mean
98574|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
98575|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
98576|NCT00827827|Primary|Change in Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
98577|NCT00827827|Primary|Change in Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||cm||Standard Error|Mean
98578|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
98579|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
98580|NCT00827827|Primary|Change in Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
98581|NCT00827827|Primary|Change in Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months||seconds||Standard Error|Mean
98582|NCT00827827|Primary|Change in Berg Balance Scale|This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points. Range is 0-56 and higher values represent a better outcome.|Baseline, 3 months|All participants for whom a Berg Score was recorded at Baseline and 3 months||Scores on a scale||Standard Error|Mean
98583|NCT00827827|Primary|Change in Peak Aerobic Capacity (VO2 Peak)||Baseline, 3 Months|All participants for whom Peak Aerobic Capacity was recorded during Graded Treadmill Test at Baseline and 3 months||mls/kg/min||Standard Error|Mean
98584|NCT00827827|Primary|Change in 10 Meter Walking Speed (Fastest)||Baseline, 3 Months|All participants for whom 10 Meter walking Speed (Fastest-Safe) was recorded at Baseline and 3 months||meters/ second||Standard Error|Mean
98585|NCT00827827|Primary|Change in 10 Meter Walking Speed (Self-Selected)||Baseline, 3 months|All participants for whom 10 Meter walking Speed (Self-Selected) was recorded at Baseline and 3 months||meters/ second||Standard Error|Mean
98586|NCT00827827|Primary|Change in 6-minute Walk Distance||Baseline, 3 Months|All participants for whom 6-minute walk distance was recorded at Baseline and 3 months||feet||Standard Error|Mean
98587|NCT00827827|Primary|Change in Leg Muscle Endurance (Non-Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months||repetitions||Standard Error|Mean
98588|NCT00827827|Primary|Change in Leg Muscle Endurance (Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 Months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months||repetitions||Standard Error|Mean
98595|NCT00827632|Primary|Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.|"Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined):~no activity~potential activity~nonactive follicle-like structure~active follicle-like structure~luteinized unruptured follicle~ovulation~Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score."|Up to 8 biweekly visits from start of OCP therapy|Two hundred twenty-six women enrolled, 150 consistent OCP users were retained for the main analysis (96 normal weight and 54 obese).||Participants|||Number
98596|NCT00827606|Secondary|Percentage of Participants by Study Drug Compliance Category|Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.|Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)|Safety Analysis Set: all participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
98597|NCT00827606|Primary|Percent Change From Baseline in FMD|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.|Months 6, 12, 18, 24, 30 and 36/ET|FMD Set; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98598|NCT00827606|Primary|Flow-Mediated Dilatation (FMD) During the Study|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.|Baseline, Months 6, 12, 18, 24, 30 and 36/ET|FMD Set: all participants enrolled in the FMD study who had at least baseline FMD measurements. n=number of participants assessed for the specified parameter at a given visit.||% FMD||Standard Deviation|Mean
98599|NCT00827606|Secondary|Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator||Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)|FAS; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
98600|NCT00827606|Primary|Percent Change From Baseline in Age: Females|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98601|NCT00827606|Primary|Age (Years) During the Study: Females|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||years||Standard Deviation|Mean
98602|NCT00827606|Primary|Percent Change From Baseline in Age: Males|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98603|NCT00827606|Primary|Age (Years) During the Study: Males|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||years||Standard Deviation|Mean
98604|NCT00827606|Primary|Percent Change From Baseline in BMI: Females|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98605|NCT00827606|Primary|BMI (kg/m^2) During the Study: Females|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg/m^2||Standard Deviation|Mean
98606|NCT00827606|Primary|Percent Change From Baseline in BMI: Males|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98607|NCT00827606|Primary|Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg/m^2||Standard Deviation|Mean
98608|NCT00827606|Primary|Percent Change From Baseline in Weight: Females|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98609|NCT00827606|Primary|Weight (kg) During the Study: Females|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg||Standard Deviation|Mean
98610|NCT00827606|Primary|Percent Change From Baseline in Weight: Males|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98611|NCT00827606|Primary|Weight (Kilograms [kg]) During the Study: Males|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||kg||Standard Deviation|Mean
98612|NCT00827606|Primary|Percent Change From Baseline in Height: Females|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98613|NCT00827606|Primary|Height (cm) During the Study: Females|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||cm||Standard Deviation|Mean
98614|NCT00827606|Primary|Percent Change From Baseline in Height: Males|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98615|NCT00827606|Primary|Height (Centimeters [cm]) During the Study: Males|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||cm||Standard Deviation|Mean
98616|NCT00827606|Primary|Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage|Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.|Baseline, Months 6, 12, 18, 24, 30, and 36/ET|FAS; n=number of participants assessed for the specific parameter at a given visit.||participants|||Number
98617|NCT00827606|Primary|Percent Change From Baseline in Apo B|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98618|NCT00827606|Primary|Apoliprotein B (Apo B; g/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||g/L||Standard Deviation|Mean
98619|NCT00827606|Primary|Percent Change From Baseline in Apo A-1|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98620|NCT00827606|Primary|Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||g/L||Standard Deviation|Mean
98621|NCT00827606|Primary|Percent Change From Baseline in VLDL|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98622|NCT00827606|Primary|Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
98623|NCT00827606|Primary|Percent Change From Baseline in Trigylcerides|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98624|NCT00827606|Primary|Trigylcerides (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
98625|NCT00827606|Primary|Percent Change From Baseline in Total Cholesterol|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98626|NCT00827606|Primary|Total Cholesterol (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
98627|NCT00827606|Primary|Percent Change From Baseline in HDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98628|NCT00827606|Primary|High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
98629|NCT00827606|Primary|Percent Change From Baseline in LDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)|FAS; n=number of participants assessed for the specified parameter at a given visit.||percent change||Standard Deviation|Mean
98630|NCT00827606|Primary|Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])|FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit.||mMol/L||Standard Deviation|Mean
98631|NCT00827567|Primary|Time to Progression(TTP)|Progression is defined by RESIST criteria as any new lesion or the sum of target lesions increasing by 20% over baseline|Each patient assessed at 8 weeks from start of study drug||||||
98632|NCT00827541|Secondary|Number of Participants With Eradication of Microbiological Pathogens|Evaluation of eradication after treatment with tigecycline included following microbiological pathogens: E. coli ESBL; K. pneumoniae ESBL; Bacteroides species RClin; S. aureus (MRSA); Enterococcus species (VRE); Enterobacter species RCef3; Serratia species RCef3; Proteus species ESBL; P. aeruginosa RCarb; A. baumannii RCarb.|Week 12|Data was not analyzed since the number of samples obtained for culture was very low.||participants|||Number
98633|NCT00827541|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Week 12|Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit.||participants|||Number
98634|NCT00827541|Secondary|Number of Participants With Susceptible Microbiological Pathogens|Evaluation of susceptibility to the tigecycline treatment included: Escherichia coli Extended Spectrum Beta Lactamases (E. coli ESBL); Klebsiella pneumoniae (K. pneumoniae) ESBL; Bacteroides species resistant to clindamycin (RClin); Staphylococcus aureus (S. aureus) methicillin resistant S. aureus (MRSA); vancomycin resistant Enterococcus (VRE) species; Resistant to third generation cephalosporins (RCef3) Enterobacter species; RCef3 Serratia species; Proteus species ESBL; carbapenem resistant (RCarb) Pseudomonas aeruginosa (P. aeruginosa); Acinetobacter baumannii (A. baumannii) RCarb.|Baseline and Week 12|Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low.||participants|||Number
98635|NCT00827541|Secondary|Percentage of Participants With Clinical Response of Cure|Cure was defined as complete resolution of infection symptoms and clinical signs of the disease to the extent that no further antibiotic treatment was required, as assessed by the attending physician.|Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment|Intent-To-Treat (ITT) population included all evaluable participants who had at least one dose of study medication and one evaluation visit. 'n' signifies those participants who were evaluated for this measure at specified time points for each group respectively.||percentage of participants|||Number
98636|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study|Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.|Baseline to 2 weeks|The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs.||Participants|||Number
98637|NCT00827502|Secondary|Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate|Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).|Baseline to 3 months|FAS||cost (in Indian Rupees) per participant||Full Range|Median
98638|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study|Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.|Baseline to 2 weeks|The full analysis set (FAS) included all subjects who received at least one dose of study medication.||participants|||Number
98639|NCT00827372|Secondary|Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions)|"The quality of life questionnaire (FACT-B+4 lymphedema questions) was given at various timepoints during the study. The values for the subscales are given for baseline, Cycle 1:Day 1, Cycle 2:Day 1, and Cycle 6:Day 1.~Physical Well-Being (PWB; sum of 7 items, point range 0-28) Social /Family Well-Being (SWB, sum of 7-items, point range 0-28) Emotional Well-Being (EWB; sum of 6-items, point range 0-24) Functional Well-Being (FWB; sum of 7-items, point range 0-28) Additional Concerns (BCS; sum of 9-items, point range 0-36) Arm subscale (AS; sum of 5-items, point range 0-20) -- This was not collected in Cycle 1 or 2.~Fact-B+4 score=Sum of PWB, SWB, EWB, FWB, BCS, AS, point range 0-164 Trial Outcome Index=Sum of PWB, FWB, BCS, point range 0-92 Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108 Fact-B score=sum of PWB, SWB, EWB, FWB, BCS, point range 0-144 Note: The higher the score, the better the outcome"|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline/Cycle 1, Day 1, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.||Units on a scale||Standard Deviation|Mean
98640|NCT00827372|Secondary|Number of Patients With Trt Related Grade 2+ AEs|This is the number of patients who had greater than or equal to Grade 2 Adverse Events related to treatment. This also includes the number of patients who had treatment related Grade 2 or greater Adverse Events that lasted more than 2 weeks (14 days) and excluded events of hypertension (labeled as 'special').|End of Treatment|All treated patients||participants|||Number
98641|NCT00827372|Secondary|Change in Impedance or ECF Volume in the Arm|"Arm impedance was reported at two baseline readings and for Cycle 2, Day 1.~To assess the degree of improvement in arm edema as measured by changes in arm impedance (ECF volume using an automated device lymphometer). Data reported is the ratio of the impedance in the affected versus unaffected arm"|Baseline, and Cycle 2, Day 1|All patients with non-missing results. This includes 8 patients at the first baseline, 10 patients at the second baseline, and 7 patients at Cycle 2, Day 1.||ratio||Standard Deviation|Median
98642|NCT00827372|Secondary|Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm|"Interstitial fluid pressure was reported at 24 hours. This is the difference in the last-first reading, affected arm.~To assess the degree of improvement in arm edema as measured by changes in interstitial fluid pressure (ECF volume using an automated device lymphometer)"|First 24 hours after drug was administered|All patients with non-missing results at both baseline and at 24 hours.||mm Hg||Standard Deviation|Mean
99330|NCT00819156|Secondary|Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.|Day 3|ITT population.||participants|||Number
98643|NCT00827372|Primary|Change in Volume Ipsilateral Lymphedema in Arm|The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days).|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.||mL||Standard Deviation|Mean
98644|NCT00827255|Secondary|Schirmer's Test at Month 12|Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.|Month 12|ITT population, which consisted of all patients included in the study with Schirmer's testing data available at baseline. Data not reported due to limited number of patients with Schirmer's test data recorded.||Millimeters per five minutes (mm/5min)||Standard Deviation|Mean
98645|NCT00827255|Primary|Percentage of Patients With Complete Clearing of Corneal Staining at Month 12|Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.|Month 12|ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline.||Percentage of Patients|||Number
98646|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume|The amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL||Standard Deviation|Mean
98647|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry|Vcomp was defined as the volume of urine voided (measured in mL using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL||Standard Deviation|Mean
98648|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry|Qmean was defined as the mean urine flow rate (measured in mL/sec using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL/sec||Standard Deviation|Mean
98649|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry|Qmax was defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).||mL/sec||Standard Deviation|Mean
98650|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores|Self-reported EF. Scores range from 0 (low or no EF) to 5 (high EF) on 6 questions (1-5, 15 of the IIEF). EF Domain scores range from 0 to 30. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. Measures were taken only for those subjects who reported they were sexually active and reported erectile dysfunction. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
98651|NCT00827242|Secondary|Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 Weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.||Units on a Scale||Standard Error|Least Squares Mean
98652|NCT00827242|Secondary|Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 1 week|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 1.||Units on a Scale||Standard Error|Least Squares Mean
98653|NCT00827242|Secondary|Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|12 weeks|All values are based on the number of subjects in the analysis population with non-missing data.||Participants|||Number
98681|NCT00827099|Secondary|Percentage of Donor and Host Chimerism of Each Cord Blood Unit|Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.|day 30, day 60, day 90|This study was terminated early. No participants were analyzed.||percentage of chimerism|||Number
98654|NCT00827242|Secondary|Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data.||Participants|||Number
98655|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
98656|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question|Measures nocturia (the need to get up at night to urinate). Scores range from 0 (few episodes of nocturia) to 5 (frequent episodes of nocturia). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
98657|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
98658|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
98659|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 12. For the 12 week analysis, the LOCF imputation technique was used.||Units on a Scale||Standard Error|Least Squares Mean
98660|NCT00827242|Secondary|Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.||Units on a Scale||Standard Error|Least Squares Mean
98661|NCT00827242|Primary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all subjects who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline visit. The Last Observation Carried Forward (LOCF) imputation technique was employed.||Units on a Scale||Standard Error|Least Squares Mean
98662|NCT00827112|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay|Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.|Baseline to Week 96 or Time of treatment Failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Participants|||Number
98682|NCT00827099|Secondary|Number of Patients That Engrafted Blood Counts by 30 Days After Transplant|Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant|Day 30|||participants|||Number
98683|NCT00827099|Primary|Number of Participants With 100 Day Transplant-related Mortality (TRM)|100 Day TRM is death within 100 days from transplant related complications|100 days|||participants|||Number
98663|NCT00827112|Secondary|Number of Participants With Phenotypic Resistance|Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Participants|||Number
98664|NCT00827112|Secondary|Number of Participants With Genotypic Resistance|Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Participants|||Number
98665|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||cells/mcL||Standard Deviation|Mean
98666|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||cells/microliter (cells/mcL)||Standard Deviation|Mean
98667|NCT00827112|Secondary|Time-Averaged Difference (TAD) in log10 Viral Load|TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).|Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure.||log10 copies/mL||Standard Error|Mean
98668|NCT00827112|Secondary|Time to Loss of Virological Response (TLOVR)|TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.|Baseline through Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.||Days||Standard Error|Mean
98669|NCT00827112|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||Percentage of participants||95% Confidence Interval|Number
98670|NCT00827112|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||Percentage of participants||95% Confidence Interval|Number
98671|NCT00827112|Secondary|Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.||log10 copies/ml||Standard Deviation|Mean
98672|NCT00827112|Secondary|Average Observed Plasma Concentration (Cavg) of Maraviroc|Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).|Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.||ng/mL||Standard Deviation|Mean
98673|NCT00827112|Secondary|Minimum Observed Plasma Concentration (Cmin) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.||ng/mL||Full Range|Median
98674|NCT00827112|Secondary|Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc.||nanogram (ng)/mL||Full Range|Median
98675|NCT00827112|Secondary|Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14|Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.|Baseline , Days 4, 7, 10 and 14|First 15 participants who were enrolled at U.S sites and had taken the study drug .||copies/mL||Standard Deviation|Mean
98676|NCT00827112|Secondary|HIV-1 RNA Levels at Baseline||Baseline|FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.||copies/mL||Standard Deviation|Mean
98677|NCT00827112|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)||Week 48|Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.||Percentage of participants||95% Confidence Interval|Number
98678|NCT00827099|Secondary|Number of Patients Who Survive Following Treatment on This Protocol|Patients will be followed until death|Through Death|This study was terminated early. No participants were analyzed.||participants|||Number
98679|NCT00827099|Secondary|Number of Patients Who Experience Disease Relapse Post-transplant|Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time.|Day 100, 6 months, 1 year, 18 months, 24 months|This study was terminated early. No participants were analyzed.||participants|||Number
98685|NCT00827073|Primary|Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs|Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.|(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)|||Ln(bacterial colony count)||Standard Deviation|Mean
98686|NCT00826943|Primary|Likert Score Rating Global Sedation|"Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.~This was mean data for all interventions."|duration of study (36 days)|per protocol||Likert score||Standard Deviation|Mean
98687|NCT00826943|Primary|Modified Epworth Sleepiness Scale|"Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.~This was mean data for all interventions."|36 days of the study|per protocol||units on a scale||Standard Deviation|Mean
98688|NCT00826943|Secondary|Total Four Symptom Scores (Allergy Symptoms)|"Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.~This was mean data for all interventions."|same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)|||TFSS scores||Standard Deviation|Mean
98689|NCT00826800|Primary|To Determine the Pathologic Complete Response (Path CR) Rate in Patients With Locally Advanced (Stage II or III) Colon Cancer to FOLFOX-bevacizumab Administered as Neoadjuvant.||3 years|||participants|||Number
98690|NCT00826618|Secondary|The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24.||2 years||||||
98691|NCT00826618|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test.||1 year||||||
98692|NCT00826618|Secondary|The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months.||1 year||||||
98693|NCT00826618|Secondary|The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test.||1 year||||||
98694|NCT00826618|Primary|Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months.|Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).|1 year|||Change in ETDRS Letters||Standard Deviation|Mean
98695|NCT00826540|Secondary|Feasibility of Study Treatment|Will be evaluated based on the number of patients who are able to > tolerate the regimen, how long they tolerate it and whether they elect to stop treatment.|Up to 2 years||||||
98696|NCT00826540|Secondary|Overall Survival|The distribution of overall survival will be estimated using Kaplan-Meier methodology.|Time from registration to death, assessed up to 2 years||||||
98697|NCT00826540|Secondary|Response Rate|Simple frequency analysis will be conducted to see if response rate is related to prior treatment and the selected tumor biomarkers. Descriptive statistics will be used to investigate how prior treatment affects various other measures as well.|Up to 2 years||||||
98698|NCT00826540|Primary|Progression-free Survival Rate|"The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.~Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|At 3 months|||percentage of participants||95% Confidence Interval|Number
98699|NCT00826449|Secondary|Phase II: Progression-Free Survival (PFS) Rate|A modified Thall, Simon, and Estey (1995) design used in the phase II study to monitor the proportion of patients with NSCLC who are alive and progression free (PFS) at twelve weeks after commencing treatment with dasatinib and erlotinib.|12 Weeks|Of the 35 participants in the Phase II portion of the study, one participant received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.||Percentage of Participants|||Number
98700|NCT00826449|Secondary|Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Patients who have a partial or complete response or stable disease are defined as progression free. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.|12 Weeks|One participant only received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.||participants|||Number
98701|NCT00826449|Primary|Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride|MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose-limiting toxicity (DLT) defined using NCI Common Terminology Common Terminology Criteria for Adverse Events (CTCAE) version 3 as: grade 3 or higher non-hematologic toxicity (excluding initial nausea and vomiting), grade 4 neutropenia, febrile neutropenia, or grade 4 thrombocytopenia. Grade 3-4 nausea and vomiting that cannot be controlled within 2 weeks with anti-emetics considered a DLT.|Baseline and at Day 21|||mg/day|||Number
99331|NCT00819156|Secondary|Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.|Day 28|ITT population.||participants|||Number
98702|NCT00826280|Secondary|Change From Baseline in Diastolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||mmHg||Full Range|Median
98703|NCT00826280|Secondary|Change From Baseline in Systolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||mmHg||Full Range|Median
98704|NCT00826280|Secondary|Change From Baseline in Heart Rate|"Baseline is the last non-missing measurement on or before first dose of regadenoson~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||Beats per minute||Full Range|Median
98705|NCT00826280|Secondary|Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).~Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).~The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||Summed Difference Score||Standard Deviation|Mean
98706|NCT00826280|Secondary|Change in Number of Reversible Defects Assessed by Computerized Quantitation|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.~Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.||Reversible Defects||Standard Deviation|Mean
98707|NCT00826280|Secondary|Change in Summed Difference Score (SDS) Across All 17 Segments|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).~Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).~The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable MPI scans.~The number of participants per arm is consistent for all categories of the data table."||Sum Difference Score||Standard Deviation|Mean
98708|NCT00826280|Primary|Change in Number of Reversible Defects|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.~Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable Myocardial Perfusion Imaging (MPI) scans.~The number of participants per arm is consistent for all categories of the data table."||Reversible Defects||Standard Deviation|Mean
98709|NCT00826267|Secondary|Changes in Biomarker in Tumour Biopsies|Changes in the biomarkers (Phospho-MAP-Kinase (MAPK), Total MAPK expression, EGFR, HER2, Phospho-EGFR and -HER2, Proliferation marker (Ki67 and p27), Apoptotic index (cleaved caspase 3), Phosphate and tensin homolog (PTEN), HER2 homodimerisation by HERmark assay and Phospho AKT) from biopsy tissue.|Screening, day 22, day 43|TS. The small number of available biomarker samples in this study did not allow for a meaningful statistical analysis.|||||
98710|NCT00826267|Secondary|Plasma Concentration of Afatinib|Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7|Day 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
98711|NCT00826267|Secondary|Change From Baseline in the Diameter of the Primary Target Lesion.|Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.|3 weeks or 6 weeks|TS||millimeters||Standard Error|Least Squares Mean
98712|NCT00826267|Secondary|Number of Participants Who Achieved Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|Tumour assessments were performed at screening, day 22 and day 43.|TS||Participants|||Number
98713|NCT00826267|Primary|Objective Response (OR)|Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, day 22 and day 43.|Treated set (TS). TS consisted of all patients who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
98714|NCT00826228|Secondary|P1NP|amino-terminal propeptide of type I collagen (P1NP)|Baseline to 6 months|Only 8 of the total 12 participants enrolled had serum available for testing||% change from baseline||Standard Deviation|Mean
98715|NCT00826228|Primary|BMD at Left Total Hip|Bone mineral density (gm/cm2) of the total hip region of interest on the left|Baseline to 6 months|||% change in BMD (gm/cm2) from baseline||Standard Deviation|Mean
98716|NCT00826202|Secondary|Pittsburgh Sleep Quality Index Score|The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and five questions rated by the bed partner or roommate. The latter five questions are used for clinical information only, are not tabulated in the scoring of the PSQI. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. These I9 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores|16 weeks|Completers at NYSPI and NKI sites||final score||Standard Deviation|Mean
98717|NCT00826202|Primary|SOPS Negative Scale|The SOPS Negative symptom scale consists of six Negative Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 36.|16 weeks|||SOPS negative final score||Standard Deviation|Mean
98718|NCT00826202|Secondary|IL6 Levels|Final IL6 levels (pg/ml) in available subjects|16 weeks|||final IL6 level (pg/ml))||Standard Deviation|Mean
98719|NCT00826202|Secondary|Scale of Prodromal Symptoms (SOPS) Total|The SOPS Total consists of five Positive Symptom items, six Negative Symptom items, four Disorganization Symptom items, and four General Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme—and Psychotic, for the positive items). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 114.|16 weeks|||units on a scale||Standard Deviation|Mean
98720|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.||minutes||95% Confidence Interval|Geometric Mean
98721|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.||minutes||95% Confidence Interval|Geometric Mean
98722|NCT00826176|Primary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.~Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary."|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.||minutes||95% Confidence Interval|Geometric Mean
98723|NCT00826111|Secondary|Change in Insomnia Severity Index Score From Baseline to Week 10|The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress.|baseline and 10 weeks|||scores on a scale||Standard Deviation|Mean
98724|NCT00826111|Secondary|Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10|The Hamilton Anxiety Rating Scale is a 14 item ordinal scale that assesses symptoms of anxiety with ratings from 0-4. The score range is 0 to 56, with a higher score indicating higher levels of anxiety. A score of 15 was designated as the cut-off for enrollment in the study.|baseline and 10 weeks|Participants who completed 10 weeks and one participant who completed 6 weeks (using last observation carried forward) were included in this analysis.||scores on a scale||Standard Deviation|Mean
98725|NCT00826111|Secondary|Change in Hamilton Depression Rating Scale Score From Baseline to Week 10|The Hamilton Depression Rating Scale is a 21 item scale that assesses symptoms of depression with items rated on a scale of 0-4 or 0-2. The total score range is 0 to 65. A score of 7 or lower is generally considered to be an absence of depressive symptoms. A score of 18 was considered to be the cut-off for enrollment in this study, as this indicates clinically significant depression. A higher score represents greater severity of depressive symptoms.|baseline and 10 weeks|||scores on a scale||Standard Deviation|Mean
98726|NCT00826111|Secondary|Change in Thalamic GABA From Baseline to Week 1|GABA levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (GABA to creatine)||Standard Deviation|Mean
98727|NCT00826111|Secondary|Change in Anterior Cingulate Cortex GABA From Baseline to Week 1|GABA levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (GABA to creatine)||Standard Deviation|Mean
98728|NCT00826111|Secondary|Change in Thalamic Glutamate From Baseline to Week 1|Glutamate levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (glutamate to creatine)||Standard Deviation|Mean
98729|NCT00826111|Secondary|Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1|Glutamate levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|||ratio (glutamate to creatine)||Standard Deviation|Mean
98730|NCT00826111|Primary|Change in Thalamic Glutamine From Baseline to Week 1|Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants were included in the analysis if they had usable spectroscopy data from baseline and week 1 and were not considered to have any confounding issues such as an abnormal structural MRI.||ratio (glutamine to creatine)||Standard Deviation|Mean
98731|NCT00826111|Primary|Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.|Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants who had usable MRS data from both the baseline and week 1 scans were included in the analysis. Participants whose data was considered unreliable were excluded.||ratio (glutamine to creatine)||Standard Deviation|Mean
98732|NCT00826007|Primary|Hypoglycemia Incidence|Blood glucose values <70 mg/dl|perioperative period|||participants|||Number
98733|NCT00825994|Secondary|Change in Hot Flash Daily Interference Scale (HFRDIS)|Vasomotor symptoms (hot flashes) were tracked by using a self-report Hot Flash Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study. Of these 20, 15 women had hot flashes at baseline and could be included in the hot flash analysis.||units on a scale||Standard Deviation|Mean
98734|NCT00825994|Primary|Change in MADRS Score|"The instrument used to measure mood at each visit was the Montgomery-Åsberg Depression Rating Scale (MADRS).~The MADRS is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden)."|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study.||units on a scale||Standard Deviation|Mean
98735|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume, and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the smooth interpolated skin surface, and was always a negative number. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters cubed||Standard Deviation|Mean
98736|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included scar measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface and was always a negative number. A more negative number was worse because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
98737|NCT00825916|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 millimeters (mm), with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in longitudinal (chronological) order. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 for each of the two raters separately. Data from the two raters was not combined.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Millimeters||Standard Deviation|Mean
98746|NCT00825812|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|The Full Analysis Set population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.||minutes||95% Confidence Interval|Geometric Mean
99408|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Baseline|Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
98738|NCT00825916|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 3 mg AZX100, and 10 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 3 mg and 10 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.||Units on a scale||Standard Deviation|Mean
98739|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left primary visual cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
98740|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of placebo was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right lingual gyrus and right superior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
98741|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right inferior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
98742|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
98743|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right occipital fusiform gyrus.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
98744|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.|Activation was measured using BOLD fMRI in response to affective faces and a fixation stimulus presented in an overt or unmasked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right insular cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
98745|NCT00825825|Primary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.|Activation was measured using BOLD fMRI in response to happy and fearful faces presented in a rapid covert or masked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left middle temporal gyrus.|two weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.||voxels|||Number
98814|NCT00824720|Primary|Visual Acuity - Left Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days|||logMARs||Standard Deviation|Mean
98747|NCT00825812|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.~The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary."|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|"The Full Analysis Set (FAS) population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.~291 subjects received IMP, of whom two had no efficacy measurements at all. Hence the FAS consisted of 289 subjects."||minutes||95% Confidence Interval|Geometric Mean
98748|NCT00825734|Secondary|Number of Patients With Adverse Events as a Measure of of Safety and Tolerability|Assessments are made through analysis of reported incidence of treatment-emergent AEs and SAEs.|every 9 weeks until treatment discontinuation or unacceptable toxicity|Patients treated at the Phase II dose||participants|||Number
98749|NCT00825734|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose||months||95% Confidence Interval|Median
98750|NCT00825734|Secondary|Objective Response Rate|Objective Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).|every 9 weeks until discontinuation of treatment|Includes patients treated at the Phase II dose who were evaluable for response||patients|||Number
98751|NCT00825734|Secondary|6-month Progression-Free Survival|Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks, up to 6 months|Includes patients treated at the Phase II dose||percentage of participants|||Number
98752|NCT00825734|Primary|Progression-Free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose||months||95% Confidence Interval|Median
98753|NCT00825682|Secondary|The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)|"examines several aspects of sleep disorders and includes 21 items that describe feelings and behaviors associated with sleep during the last week. It uses a 0 (never) to 7 (every day) Likert scale on questions like feeling nervous during the day; falling asleep while unplanned and using sleeping pills.~A total sleep disturbance score was calculated as the average of all 21 items (ranging between 0 and 7), higher scores indicating a worse outcome."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 34 women in the experimental group and 20 in the control group.||Scores on a scale||Standard Deviation|Mean
98754|NCT00825682|Secondary|The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).|"The questionnaire includes 33 items describing different forms in which the disease may affect patient's quality of life. For each item, subjects are asked to mark the number that best describes their feelings right now, in a Likert scale ranging between 0 and 10. Items include happiness feelings, anxiety levels, how affected are the social ties because of the disease, etc.~A total quality of life score was calculated as the average of all 33 items (ranging between 0 and 10), higher scores indicating a better quality of life."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final ananlysis included 34 women in the experimental group, and 20 women in the control group.||Scores on a scale||Standard Deviation|Mean
98755|NCT00825682|Primary|The Lee Fatigue Scale|"The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subscale (range from 0-10) are calculated. Higher scores indicate higher levels of perceived fatigue and energy . Items in the energy subscale were recoded, and a Lee fatigue total score was calculated as the average of all 18 items (ranging between 0 and 10), higher scores indicating higher levels of fatigue.~The Cronbach's Alpha reliability coefficient of the English version of the questionnaire is 0.77 . The questionnaire's validity and reliability have been established in cancer patients."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 33 women in the experimental group and 20 in the control group.||units on a scale||Standard Deviation|Mean
98756|NCT00825630|Primary|Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.|Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.|17 days|Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study.||participants|||Number
98757|NCT00825565|Primary|Physician Assessment of Individual Signs|"In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated.~This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe"|baseline and then every 4 weeks for a total of 12 weeks||||||
98758|NCT00825565|Primary|Physician Global Assessment of Severity (PGAS)|"The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a global impression.~This scale produced a score with the following correlations:~0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)"|baseline and then every 4 weeks for a total of 12 weeks||||||
98759|NCT00825565|Primary|Target Wound Size Reduction or Closure|"EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream.~Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream on the target wound daily up to full closure of that wound were included in the analysis.||number of unhealed target wounds|||Number
98760|NCT00825565|Primary|Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage|"A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease spread with weighting factors."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream for an entire month prior to the BSA monthly assessment were included in the analysis.||percentage of BSA involvement||Standard Deviation|Mean
98761|NCT00825344|Primary|Numerical Rating Scale Pain Score|0-10 pain score through 24-hours post-surgery. 0 is no pain and 10 is the worse pain imaginable. The primary outcome reported measure is the average of 4 scores, each comprised of 6-hour time intervals during the 24hour period.|24 hours|||units on a scale||Standard Deviation|Mean
98762|NCT00825344|Secondary|Chronic Post-surgical Pain|Patients with persistent post-surgical pain|Up to 12 months|||participants|||Number
98763|NCT00825344|Secondary|Analgesic Usage|Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery|24 hours|||tablets||Standard Deviation|Mean
98764|NCT00825344|Primary|Numerical Rating Pain Score|0-10 pain score|24 hours||||||
98765|NCT00825318|Primary|Mean Arterial Blood Pressure||Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)|||mm Hg||Full Range|Mean
98766|NCT00825305|Secondary|Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.|Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.|7 days, 14 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.||percentages of participants||95% Confidence Interval|Mean
98767|NCT00825305|Primary|Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination|Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.|7 days after each vaccination|Safety was analyzed for the safety set. One enrolled subject was not vaccinated and not included in the safety set because of inappropriate inclusion.||participants|||Number
98768|NCT00825305|Secondary|Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.|Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|7 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.||IU/ml||95% Confidence Interval|Log Mean
98769|NCT00825305|Primary|Rabies Virus Neutralizing Antibody Concentrations on Day 14.|Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|14 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.||IU/mL||95% Confidence Interval|Log Mean
98770|NCT00825227|Secondary|Change in the Brief Fatigue Inventory (BFI) Global Score|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)||||||
98771|NCT00825227|Secondary|Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)||||||
99409|NCT00819390|Secondary|Percent CD8 CD38+ at Week 24|Results reported are the week 24 percentage of CD8 expressing CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
98772|NCT00825227|Primary|Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire|Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.|Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)|Study was discontinued after only 6 subjects were enrolled due to a business decision, so no outcome analysis was done.||units on a scale||Standard Deviation|Mean
98773|NCT00825175|Primary|Time Performing Upright Play Skills|20 minute session of playing in upright. This is video recorded and behavior coded|bi-monthly; starting when child can pull to stand and ending at walking onset||||||
98774|NCT00825175|Primary|Gait Parameters||1 month after walking onset||||||
98775|NCT00825175|Primary|Pattern of Gross Motor Development|Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.|monthly; starting when child can pull to stand and ending when the test determined that the child was walking.|analysis was on protocol||months||Standard Deviation|Mean
98776|NCT00825162|Secondary|Frequency of New Onsets of Chronic Illness||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.||Participants|||Number
98777|NCT00825162|Secondary|Frequency of Serious Adverse Events||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.||Participants|||Number
98778|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Days||Standard Deviation|Mean
98779|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Participants|||Number
98780|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Days||Standard Deviation|Mean
98781|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Participants|||Number
98782|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Days||Standard Deviation|Mean
98783|NCT00825162|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Event.|30 days after each study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.||Participants|||Number
98784|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.||Participants|||Number
98815|NCT00824720|Primary|Visual Acuity - Right Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days|||logMAR units||Standard Deviation|Mean
98816|NCT00824720|Secondary|Intraocular Pressure (IOP)||from baseline to 14 days|The analysis population includes all subjects with a plug insertion that completed the study per protocol.||mmHg||Standard Deviation|Mean
98785|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
98786|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
98787|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination|Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), >39 but ≤40 degrees C (moderate), or >40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention).|Baseline up to 4 days after vaccination on Day 1|Safety population; N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).||percentage of participants|||Number
98788|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination|Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (> 7.0 cm). Participants may be represented in >1 category.|Baseline up to 4 days after vaccination on Day 1|Safety population included all participants who received the vaccine. N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).||percentage of participants|||Number
98789|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.||Titer||95% Confidence Interval|Geometric Mean
98790|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.||Titer||95% Confidence Interval|Geometric Mean
98791|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.||Mcg/mL||95% Confidence Interval|Geometric Mean
98792|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.||Mcg/mL||95% Confidence Interval|Geometric Mean
98817|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
98793|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Titer||95% Confidence Interval|Geometric Mean
98794|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Titer||95% Confidence Interval|Geometric Mean
98795|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Titer||95% Confidence Interval|Geometric Mean
98796|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Titer||95% Confidence Interval|Geometric Mean
98797|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.||Mcg/mL||95% Confidence Interval|Geometric Mean
98798|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Mcg/mL||95% Confidence Interval|Geometric Mean
98799|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Mcg/mL||95% Confidence Interval|Geometric Mean
98800|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population. GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.||Mcg/mL||95% Confidence Interval|Geometric Mean
98818|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
98801|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
98802|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.||observed percentage of participants||95% Confidence Interval|Number
98803|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate IgG antibody concentration for the serotypes.||observed percentage of participants||95% Confidence Interval|Number
98804|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants.|Day 28 (Visit 5)|Evaluable Immunogenicity population: eligible participants based on all inclusion and exclusion criteria, had a baseline blood sample collection performed (Visit 1), received 1 dose of 13vPnC, and had Visit 5 blood sample collection performed, and at least 1 valid and determinate assay result at Visit 1 and also at Visit 5.||observed percentage of participants||95% Confidence Interval|Number
98805|NCT00824824|Primary|Presence of Retinal Vascular Dysregulation (RVD)|We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.|6 weeks post treatment|21 participants were tested for RVD after 6 weeks of timolol treatment. Of the 21 participants who were tested, 7 had RVD and were randomized to Dorzolamide-Timolol and Brimonidine-Timolol; 14 had normal autoregulation. One participant was removed from the analysis in the Brimonidine-Timolol arm due to technical difficulties with equipment.||Participants|||Number
98806|NCT00824772|Secondary|Postoperative Cumulative Fentanyl Consumption||48hr after surgery|||mcg||Standard Deviation|Mean
98807|NCT00824772|Primary|Postoperative Cumulative Fentanyl Consumption||24 hr after surgery|||mcg||Standard Deviation|Mean
98808|NCT00824746|Secondary|Overall Survival||2 years|||days||95% Confidence Interval|Median
98809|NCT00824746|Primary|Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT|Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).|8 weeks|we analysed the data of 23 patients who were enrolled to this study(intention-to-treat (ITT) population).||percentage of participant with DC||95% Confidence Interval|Number
98810|NCT00824746|Secondary|Progression - Free Survival of Patients Retreated With Gefitinib|Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks.|two year|||days||95% Confidence Interval|Median
98811|NCT00824733|Secondary|Combination of PF-03512676 and Trastuzumab Induces MIP-1 (Macrophage Inflammatory Protein 1), MCP-1 (Monocyte Chemoattract Protein 1) and RANTES.||up to 18 weeks|The study was terminated early due to poor patient accrual and no data was collected and analyzed.|||||
98812|NCT00824733|Secondary|Progression-free Survival for Patients With Metastatic Breast Cancer That Are Receiving Trastuzumab Plus PF-03512676|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 18 weeks|||weeks||Full Range|Median
98813|NCT00824733|Primary|PF-03512676 Augments Antibody Mediated Cytoxicity (ADCC)Against Trastuzumab-coated Target Cells in Metastatic HER2 Overexpressing Breast Cancer.||up to 18 weeks|Samples were not analyzed for primary endpoint due to the sample numbers being too small. No data were collected from the samples.|||||
99410|NCT00819390|Secondary|Percent CD8 CD38+ at Week 12|Results reported are the week 12 percentage of CD8 expressing CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
98819|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
98820|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic||Percentage of participants|||Number
98821|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.|12 months of age (prior to toddler dose)|Evaluable Toddler Immunogenicity Population||mcg/mL||95% Confidence Interval|Geometric Mean
98822|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population||mcg/mL||95% Confidence Interval|Geometric Mean
98823|NCT00824655|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
98824|NCT00824655|Primary|Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
98825|NCT00824616|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.|From first dose of study drug (Week 0) to last dose of study drug (Week 20)|All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo).||participants|||Number
98826|NCT00824616|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) Level|HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.|Baseline (Day 1) and End of Treatment (Week 20)|Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement.||% HbA1c||95% Confidence Interval|Least Squares Mean
98827|NCT00824564|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 5 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||Participants||95% Confidence Interval|Number
98828|NCT00824564|Secondary|Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery||Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||gram/deciliter (g/dl)||Standard Deviation|Mean
98829|NCT00824564|Secondary|Number of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent.|Up to day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||Participants||95% Confidence Interval|Number
98830|NCT00824564|Secondary|Total Blood Loss Assessed by Gross’ Formula|Gross’s formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||mL||Standard Deviation|Mean
98831|NCT00824564|Secondary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|1, 4, 8 and 24 hours post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||mL||Standard Deviation|Mean
98832|NCT00824564|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.||mL||Standard Deviation|Mean
98833|NCT00824564|Primary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 7 post-surgery|Full analysis set (FAS) included all participants who were randomized to study treatment and received at least one dose of study medication.||Milliliters (mL)||Standard Deviation|Mean
98834|NCT00824538|Secondary|Effect of Sunitinib Malate on OTC in Peripheral Blood||one year||||||
98835|NCT00824538|Secondary|Relapse-free and Overall Survival||up to 3 years||12/2013||||
98836|NCT00824538|Secondary|Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0||up to 7 months|||participants|||Number
98837|NCT00824538|Secondary|Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study||6 months|||participants|||Number
98838|NCT00824538|Primary|Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow|DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL|Baseline, 6 months|||percentage of change||Full Range|Mean
98839|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Investigator|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mm||Full Range|Median
98840|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Parents|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mm||Full Range|Median
98841|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Patient|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mm||Full Range|Median
98842|NCT00824512|Secondary|Choice Reaction Time Test- Movement Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||millisecond||Full Range|Median
98843|NCT00824512|Secondary|Choice Reaction Time Test- Reaction Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||millisecond||Full Range|Median
98844|NCT00824512|Secondary|Nine Hole Peg Test (Nondominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
98856|NCT00824512|Secondary|Muscle Reoxygenation Rate Post Exercise.|Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||per second||Full Range|Median
98845|NCT00824512|Secondary|Nine Hole Peg Test (Dominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
98846|NCT00824512|Secondary|Timed 25-foot Walk Test||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
98847|NCT00824512|Secondary|ICARS (Oculomotor Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Oculomotor Disorders. Oculomotor Disorders score range from 0 to 6 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
98848|NCT00824512|Secondary|ICARS (Speech Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Speech Disorders. Speech Disorders Score range from 0 to 8 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
98849|NCT00824512|Secondary|ICARS (Kinetic Function Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Kinetic Function. Kinetic Function score range from 0 to 52 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
98850|NCT00824512|Secondary|ICARS (Posture and Gait Disturbance Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Posture and gait disturbances. Posture and gait disturbances score range from 0 to 34 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
98851|NCT00824512|Secondary|International Cooperative Ataxia Rating Scale [ICARS] (Total Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales (i.e. Posture and gait disturbances, Kinetic functions, Speech disorders, & Oculomotor disorders). Scores for each subscale quantify the extent of ataxia in each clinically important area and subscale scores are also summed to give a total score ranging from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||score on a scale||Full Range|Median
98852|NCT00824512|Secondary|Metabolism Efficacy Index|The metabolism efficacy index was derived as Normalised work x creatine phosphorylation rate (sec-1). [Normalised work was derived as Work developed during the exercise/(60 X Maximum cross section of muscle-1100)]. Greater values of Metabolism Efficacy index indicate improvement in skeletal muscle energetics while lower values indicate the reverse. Negative values obtained using the formula indicated severe levels of muscle weakness.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||per second||Full Range|Median
98853|NCT00824512|Secondary|Normalised Work Developed During the Exercise|"Normalised work developed during the exercise was derived as Work developed during the exercise/([60 X Maximum cross section of muscle]-1100).~Normalised work measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy."|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||Joules/cm^2||Full Range|Median
98854|NCT00824512|Secondary|Developed Force During the Exercise Bout|Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||Joules||Full Range|Median
98855|NCT00824512|Secondary|Muscle Trophicity: Maximum Cross Section of Muscle|Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm^2)|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||cm^2||Full Range|Median
98869|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 2||2 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 2."||mmol/L||Standard Deviation|Mean
98857|NCT00824512|Secondary|Perfusion-time Integral During the First 9 Minutes Post Exercise.|The integral of 'peak perfusion' over a period of 9 minutes post exercise.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||mL/100 g of tissue||Full Range|Median
98858|NCT00824512|Secondary|Time to Peak Perfusion||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||seconds||Full Range|Median
98859|NCT00824512|Secondary|Peak Post Exercise Perfusion|Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||ml/mn/100 g of tissue||Full Range|Median
98860|NCT00824512|Primary|Creatine Rephosphorylation Rate Post Exercise|Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.||pH per second||Full Range|Median
98861|NCT00824473|Secondary|Change From Baseline on Direct Visual Nasal Exams to 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion,Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days|||Participants|||Number
98862|NCT00824473|Secondary|Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Scores for a series of subsclaes are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|14 Days|||Units on a Scale||Standard Deviation|Least Squares Mean
98863|NCT00824473|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible TOSS score is 9 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to14 Days|||Scores on a scale||Standard Deviation|Least Squares Mean
98864|NCT00824473|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to 14 Days|||scores on a scale||Standard Deviation|Least Squares Mean
98865|NCT00824473|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline to 14 Days|||Score on a scale||Standard Deviation|Least Squares Mean
98866|NCT00824473|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days|||Scores on a scale||Standard Deviation|Least Squares Mean
98867|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 5||5 weeks after baseline|"For this Secondary Outcome, FAS population was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had a serum-phosphate measurement at Week 5."||mmol/L||Standard Deviation|Mean
98868|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 4||4 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 4."||mmol/L||Standard Deviation|Mean
98920|NCT00824382|Secondary|Difference From Baseline in Potassium|Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable.|Baseline, Week 4|Treated set.||mmol/L||Standard Deviation|Mean
98870|NCT00824460|Primary|Change From Baseline in Serum-phosphate Levels at the End of Treatment.||6 weeks after baseline|For the Primary Outcome, data from the Full Analysis Set (FAS) was used. The FAS consists of all randomised subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).||mmol/L||Standard Deviation|Mean
98871|NCT00824434|Secondary|Technical Success|Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.|Acute-At time of index procedure|Intention to treat||percentage of stents attempted|Participants||Number
98872|NCT00824434|Secondary|Clinical Procedural Success|Mean lesion diameter stenosis < 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR|Duration of hospital stay (usually 1-2 days)|Analysis was intention to treat||percentage of participants|||Number
98873|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98874|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98875|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98876|NCT00824434|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98877|NCT00824434|Secondary|Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98878|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98879|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98880|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98881|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98882|NCT00824434|Secondary|All-cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98921|NCT00824382|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|4 weeks|Treated set.||percentage of participants|||Number
98883|NCT00824434|Secondary|Myocardial Infarction (MI)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98884|NCT00824434|Secondary|Occurance of Post-procedure Incomplete Stent Apposition|Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound|Post-procedure|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) and who underwent intravascular ultrasound to determine extent of stent apposition||percentage of participants|||Number
98885|NCT00824434|Secondary|In-stent Late Loss|In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)|9 months|Analysis was intention to treat; all patients in the study with workhorse lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) underwent clinical follow up to provide the information needed for this endpoint.||millimeters||Standard Deviation|Mean
98886|NCT00824434|Primary|Cardiac Events (Composite)|Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium [ARC] definitions); see below for definitions of individual components.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
98887|NCT00824421|Secondary|Plasma Concentration of Lersivirine at 24 Hour|The observed plasma concentration at 24 hours post-dose (C 24h).|24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who further consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
98888|NCT00824421|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||hr||Full Range|Median
98889|NCT00824421|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
98890|NCT00824421|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0-24). Only participants from Lersivirine treatment arms were planned to be analyzed for Pharmacokinetic (PK) sub-study.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4|Pharmacokinetic sub-study analysis set (PKSSAS) included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
98891|NCT00824421|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, it was deemed that the interpretation of the pharmacokinetic/pharmacodynamic (PK/PD) results would be questionable, thus data was not analyzed.|||||
98892|NCT00824421|Secondary|Population Pharmacokinetic (PK) of Lersivirine|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the participant flow and baseline characteristics modules.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48||||||
98893|NCT00824421|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included hematology, blood chemistry, serum and urine pregnancy test, hepatitis testing and urinalysis. Laboratory values that met the criteria of the Division of Acquired Immuno Deficiency Syndrome (DAIDS) grade 1 (mild, symptoms causing no or minimal interference with usual social and functional activities) or greater were considered as abnormal.|Baseline up to Week 96 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
98894|NCT00824421|Secondary|Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96|Phenotypic resistance and genotypic resistance was assessed for all participants at Day 1 predose, and was evaluated for nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) resistance-associated mutations at time of treatment failure using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure, up to Week 96.|Day 1 (pre-dose) through Week 24, 48, 96|Virology analysis set (TLOVR50 failures) included all participants who meet the TLOVR50 failure definition. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point for each group, respectively.||participants|||Number
98922|NCT00824382|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol )|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Number of puffs||Standard Error|Mean
98895|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.||percentage of total lymphocytes||Standard Deviation|Mean
98896|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.||cells per microliter (cells/mcL)||Standard Deviation|Mean
98897|NCT00824421|Secondary|Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response is compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; met treatment failure [TF] criteria). TF: an increase to at least 3 times baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL). TF criteria’s defined above were confirmed by second measurement at least 14 days after first. In 'TLOVR50', '50' denotes the lower limit of quantification (LLOQ) of assay (which is 50 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Missing value was imputed per the TLOVR algorithm.||percentage of participants|||Number
98898|NCT00824421|Secondary|Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as area under the curve of HIV-1 RNA levels (log10 copies/mL) from baseline to the time point of interest divided by time period in weeks minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline up to Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation was missing: value calculated to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.||log10 copies/mL||Standard Deviation|Mean
98899|NCT00824421|Secondary|Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|For the log 10 scale, all the HIV-1 RNA levels were log 10 transformed prior to the average calculations. Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: Last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.||log 10 copies/mL||Standard Deviation|Mean
98900|NCT00824421|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=400 copies/mL and were referred to as non-completer = failure.||percentage of participants|||Number
98901|NCT00824421|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.||percentage of participants|||Number
98902|NCT00824421|Primary|Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 48|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.||percentage of participants|||Number
98903|NCT00824408|Secondary|Vss of Pemetrexed|Vss - apparent volume of distribution at steady state following IV administration of pemetrexed|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data||Litres||Geometric Coefficient of Variation|Geometric Mean
98904|NCT00824408|Secondary|CL of Pemetrexed|CL - total clearance of pemetrexed in plasma after IV administration|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data||mL/min||Geometric Coefficient of Variation|Geometric Mean
98905|NCT00824408|Secondary|Cmax of Pemetrexed|Cmax - maximum measured concentration of pemetrexed in plasma|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
98906|NCT00824408|Secondary|Vss of Volasertib|Vss - apparent volume of distribution at steady state following IV administration of volasertib|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data||Litres||Geometric Coefficient of Variation|Geometric Mean
98907|NCT00824408|Secondary|Total Clearance (CL) of Volasertib|CL - total clearance of volasertib in plasma after IV administration|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data||mL/min||Geometric Coefficient of Variation|Geometric Mean
98908|NCT00824408|Secondary|Cmax of Volasertib|Cmax - maximum measured concentration of volasertib in plasma.|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|Pharmacokinetic (PK) set, which included all patients in the treated set with volasertib monotherapy or combined with pemetrexed and provided at least 1 blood sample for measurement of volasertib (BI 6727) or pemetrexed. Including patients with evaluable data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
98909|NCT00824408|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities|Frequency of patients with possible clinically significant abnormalities|From first drug infusion until 21 days after last drug infusion, up to 1100 days|On-treatment for lab||participants|||Number
98910|NCT00824408|Secondary|Occurence of DLT|"Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:~treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).~treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.~CTCAE Grade 4 thrombocytopenia."|Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.|Treated set, run-in phase, first course only||participants|||Number
98911|NCT00824408|Secondary|Occurrence and Intensity of AEs Graded According to CTCAE.|All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (CTCAE).|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Treated set, which included all patients who were dispensed and were documented to have taken at least one dose of investigational treatment.||participants|||Number
98912|NCT00824408|Secondary|Duration of Overall Response|The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.|From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented|Randomized phase II set||weeks||Inter-Quartile Range|Median
98913|NCT00824408|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the duration of time from randomization to time of death.|From randomization until time of death|Randomized phase II set, including only patients who died.||months||95% Confidence Interval|Median
98914|NCT00824408|Secondary|Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.|Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Randomized set||percentage of participants|||Number
98915|NCT00824408|Primary|Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.|"Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.~The number of participants analysed displays the number of patients with an event (progression)."|From randomization until disease progression or death|Randomized phase II set, which included all patients who were randomized as part of phase II of the study (not the run in phase)||months||95% Confidence Interval|Median
98916|NCT00824382|Secondary|AUC0-1,ss|Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
98917|NCT00824382|Secondary|AUC0-1|Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
98918|NCT00824382|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)|Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg/mL||Geometric Coefficient of Variation|Geometric Mean
98919|NCT00824382|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)||pg/mL||Geometric Coefficient of Variation|Geometric Mean
98923|NCT00824382|Secondary|Weekly Mean Evening PEFR After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,~Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter/minute||Standard Error|Least Squares Mean
98924|NCT00824382|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,~Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter/minute||Standard Error|Least Squares Mean
98925|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.~FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|Baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter||Standard Error|Least Squares Mean
98926|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.~FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation||Liter||Standard Error|Least Squares Mean
98927|NCT00824382|Secondary|FVC Peak(0-3) Response|The change from baseline in FVC peak(0-3) response after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
98928|NCT00824382|Secondary|FVC AUC(0-3) Response|"The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.~Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
98929|NCT00824382|Secondary|Trough FVC Response at Week 4|The change from baseline in Trough FVC after 4 weeks of treatment|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
98930|NCT00824382|Secondary|FEV1 Peak(0-3) Response at 4 Weeks|The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
98931|NCT00824382|Secondary|FEV1 AUC(0-3) Response at 4 Weeks|"The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.~Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
98932|NCT00824382|Secondary|Trough FEV1 Response at Week 2|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication|baseline and after 2 weeks treatment|The full analysis set (FAS) - analysis with imputation||Liter||Standard Error|Least Squares Mean
98933|NCT00824382|Primary|Trough FEV1 Response at Week 4|The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation||Liter||Standard Error|Least Squares Mean
98934|NCT00824369|Secondary|CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.||Percentage of total lymphocytes||Standard Deviation|Mean
98935|NCT00824369|Secondary|Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.||cells/uL||Standard Deviation|Mean
98936|NCT00824369|Secondary|Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.||Number of participants|||Number
98937|NCT00824369|Secondary|Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ > 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.||Number of participants|||Number
98938|NCT00824369|Primary|Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events|The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.|End of Study visit or the Early Termination visit|Safety population consisted of all participants who were enrolled in this study.||Number of participants|||Number
98939|NCT00824291|Secondary|Change From Baseline on Stress and Social Support Scales at Week 12|Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
98940|NCT00824291|Secondary|Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12|WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
98941|NCT00824291|Secondary|Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
98942|NCT00824291|Secondary|Change From Baseline on Work and Activities Item of HAM-D17 at Week 12|The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
98943|NCT00824291|Secondary|Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale|||Number
98944|NCT00824291|Secondary|Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale|||Number
98945|NCT00824291|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12|Participant rated scale was used to assess the effect of the participant’s symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant’s work/social/family life. Individual item scores range from 0 to 10.|At Baseline and Week 12.|ITT, LOCF||Scores on a scale||Standard Error|Mean
98946|NCT00824291|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.|At Baseline and Week 12.|Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF)||Scores on a scale||Standard Error|Mean
98947|NCT00824265|Secondary|Time of Occurrence of Cmax (Tmax) of Ofatumumab|Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4.|Cycle 1 Week 1, Cycle 1 Week 2, Cycle 4|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)||Hour||95% Confidence Interval|Geometric Mean
98948|NCT00824265|Secondary|Maximum Concentration (Cmax) and Observed Drug Concentration Prior to the Next Dose (Ctrough) of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab.Cmax and Ctrough were determined. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
98949|NCT00824265|Secondary|Mean Area Under the Time-concentration Curve (AUC) Curve Over the Dosing Interval (AUC[0-tau]) of Ofatumumab|Area under the time-concentration curve (AUC) over the dosing interval (AUC[0-tau]) was evaluated. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5,6|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)||hour*nanogram/mililiter (h*ng/mL)||95% Confidence Interval|Geometric Mean
99411|NCT00819390|Secondary|Percent CD8 CD38+ at Baseline|Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
98950|NCT00824265|Secondary|Mean of Health Change Questionnaire (HCQ)|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for ‘my health is a great deal better’ to 9 for ‘my health is a great deal worse’ since the beginning of the study. Lower scores represent better conditions.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.||Unit on a scale||Standard Deviation|Mean
98951|NCT00824265|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30, a self-reported, cancer-specific instrument assessing 15 domains: physical, role, emotional, cognitive and social functioning, pain,fatigue, nausea and vomiting, insomnia, loss of appetite, constipation, diarrhea, and dyspnea, financial difficulties and a global health status/quality of life (QOF). Functional and symptoms scales were measured on four point Likert scale where 1 = not at all and 4 = very much. Pat. assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Clinically meaningful changes or minimally important differences (MIDs)have been previously established for the EORTC QLQ C30, and categorized as ‘small’ if the mean change in scores is 5-10 points, ‘moderate’ if 10-20 points, and ‘large’ if >20points.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed||Scores on a scale||Standard Deviation|Mean
98952|NCT00824265|Secondary|Change From Baseline in Patient Reported Outcome (PRO) as Assessed by EuroQoL Five-Dimension (EQ-5D) Score at Indicated Visit|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem(s) and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (death) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A Negative health status describes health state worse than death.Baseline is the most recent, non-missing value prior to or on the first study drug dose date.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.||Score on a scale||Standard Deviation|Mean
98953|NCT00824265|Secondary|Changes in Patient Reported Outcome (PRO) Measures and Scores for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection scale [IS] (4 items) – and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value was obtained at randomization.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|Participants||scores on a scale||Standard Deviation|Mean
98954|NCT00824265|Secondary|Prognostic and Biological Markers Correlating With Clinical Response|Blood samples were collected for the assessment of the following prognostic markers at BL: immunoglobulin heavy chain variable region(IgVH) homology; Zeta-Chain-Associated Protein Kinase 70(ZAP70), VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]); beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH included 6q-,11q-, +12q, 17p-, 13q-) , ZAP-70 (positive, negative or intermediate), VH3-21 usage (Yes and No), IgVH homology (>98%, 97%-98% and <97%), beta 2 microglobulin (>3500 microgram per liter [µg/L] and <=3500 µg/L). For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=cytogenetics (CY G).|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
98955|NCT00824265|Secondary|Change From Baseline in Cell Counts, CD5- CD19+|CD5- CD19+ cells were counted by flow cytometry at Screening (baseline) at Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during treatment period and after last dose of study drug at 1 M and then every three month up to 45 M during follow up period. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. Day 1 if available otherwise screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three month up to 45 M during Follow-up Period|Safety Population||cells/uL||Standard Deviation|Mean
98965|NCT00824265|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD) Assessed by IRC|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
98956|NCT00824265|Secondary|Change From Baseline in Cluster of Differentiation (CD) Cell Counts, CD5+ and CD19+|CD5+ and CD19+ cells were counted by flow cytometry at Screening (Baseline) on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during the treatment period and after last dose of study drug at 1 M and then every three month follow up up to 45 M. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. day 1 if available, otherwise, screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three months up to 45 M during Follow-up Period|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||cells/uL||Standard Deviation|Mean
98957|NCT00824265|Secondary|Mean Level of Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. Blood samples were collected from each participant and IgA, IgG, and IgM were measured at Baseline, and 1M and 6M after last dose during follow up period.|Baseline, 1M and 6M follow up|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Gram per liter||Standard Deviation|Mean
98958|NCT00824265|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products or blood supportive care product are included.|From randomization up to 5 years after last dose of study drug|Safety Population||Participants|||Number
98959|NCT00824265|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with at least one Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population||Participants|||Number
98960|NCT00824265|Secondary|Number of Participants With Drug Related AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population||Participants|||Number
98961|NCT00824265|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA)|"AIHA is a condition where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants experienced AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population||Participants|||Number
98962|NCT00824265|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result at Indicated Time Points|Serum samples for analysis of HAHA were collected at Baseline (Screening), after 3 cycles were compelted, after 1 M and 6 M post last dose. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive.|From start of study drug until 60 days after the last dose of study medication|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles)||Participants|||Number
98963|NCT00824265|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From first dose of study medication to 60 Days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population: Participants who received at least one dose of a study drug.||Participants|||Number
98964|NCT00824265|Secondary|Number of Participants Who Were Negative for MRD Assessed by Investigator|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
98974|NCT00824265|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the last IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization up to 5 years after last dose of study drug|ITT Population.||Months||95% Confidence Interval|Median
98966|NCT00824265|Secondary|Percentage of Participants With the Best OR, as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population||Percentage of participants|||Number
98967|NCT00824265|Secondary|Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population||Percentage of participants|||Number
98968|NCT00824265|Secondary|Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time|Participants with no B-symptoms (B-Sy) (no night sweat, no weight loss, no fever and no extreme fatigue) and at least one indicated B-sy(night sweats, weight loss, fever or extreme fatigue) were presented at Screening, Cycle 1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and during follow up period at 1 M after study drug therapy, then every 3 M up to 5 year (up to 60 months).|Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, then every 3 M up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
98969|NCT00824265|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. ECOG performance status are measured at Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1 and Cycle 6 Day1. During follow period, 1 M after study drug therapy, then every 3 month up to 5 year (up to 60 months). Improvement is defined as a decrease from baseline by at least one step on the ECOG performance status scale (yes/no).|Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, then every 3 month up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Participants|||Number
98970|NCT00824265|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug)|ITT Population||Months||95% Confidence Interval|Median
98971|NCT00824265|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to PD. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From randomization up to 5 years after the last dose of study drug|ITT Population.||Months||95% Confidence Interval|Median
98972|NCT00824265|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug)|ITT Population. Par with unknown or missing responses were considered as non-responders, only responders were included in this analysis.||Months||95% Confidence Interval|Median
98973|NCT00824265|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response. Complete Response/remission(CR) all the criteria at least 2 months after last treatment: no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/spleenomegaly/constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. Incomplete bone marrow recovery(CRi): CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. Partial Remission/response(PR): >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. Nodular PR(nPR): persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population. Participants with unknown or missing responses were considered as non-responders. Only responders were included in the analysis.||Months||95% Confidence Interval|Median
98975|NCT00824265|Primary|Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (progressive disease,PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From randomization up to 5 years after last dose of study drug|Intent-to-Treat (ITT) Population: all participants randomized and received study drug.||Months||95% Confidence Interval|Median
98976|NCT00824161|Secondary|Overall Survival|Overall survival is defined as the period from the date of first dose of TAS-109 to death date.|From the initial treatment until 12 months after enrollment of the last patient.|Analysis was Intent to Treat(ITT) population.||months||95% Confidence Interval|Median
98977|NCT00824161|Secondary|Antitumor Activity|Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.|From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.|Intent to treatment(ITT)||percentage of CR plus PR patients||95% Confidence Interval|Number
98978|NCT00824161|Primary|Percentage of Progression Free Survival|The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.|From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.|Analysis was Intent to treatment(ITT) population.||percentage of PFS patients||95% Confidence Interval|Number
98979|NCT00824070|Primary|The Aqueous Humor Drug Concentration.|An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.|Visit 2, 1-14 days following screening visit|Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.||µg/mL|Participants|Standard Deviation|Mean
98980|NCT00824044|Primary|QEEG Metrics (ATR, EEG Bispectrum, Cordance Estimates)||12 weeks||||||
98981|NCT00824044|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.|12 weeks|The number of participants for analysis was based on the number of participants who completed treatment (12 weeks of CBT or medication)||units on a scale||Standard Deviation|Mean
98982|NCT00823264|Primary|Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels|We enrolled patients with elevated phenytoin levels into the study with greater than 30 ug/cc. The treatment arm received multiple doses of activated charcoal and the control arm received no activated charcoal. We obtained serum phenytoin levels every 6 hours for 24 hours then once every 24 hours. The time to reach a subtoxic level was determined in each arm by looking at serum phenytoin levels and documenting when it was below 25 ug/cc.|Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours|||hours||Inter-Quartile Range|Median
98983|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)|Mean residence time of the unchanged drug in the systemic circulation|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||hours||Geometric Coefficient of Variation|Geometric Mean
98984|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
98985|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subject did not contribute to PK evaluation.||mL/kg||Geometric Coefficient of Variation|Geometric Mean
98986|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Total Clearance (CL)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subjects did not contribute to data.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
98987|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to data.||hours||Geometric Coefficient of Variation|Geometric Mean
98988|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Terminal Slope (λz)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||1/h||Geometric Coefficient of Variation|Geometric Mean
98989|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
98990|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
98991|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||IU/mL||Geometric Coefficient of Variation|Geometric Mean
98992|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)|AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
98993|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)|Blood samples were collected at following time points: -30 min, -20 min, -10 min, 5 min, 10 min, 20 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 8h, 12h and 24h to calculate area under the curve.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
98994|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)|AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
98995|NCT00822185|Primary|Subjects With Anti-Vatreptacog Alfa Antibody|Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody|between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.||participants|||Number
98996|NCT00822185|Primary|Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))|Any safety issue was reported as AE|between dosing and 2-3 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.||number of events|||Number
98997|NCT00822172|Secondary|The Effect of the Combination of Cilostazol and L-carnitine on Claudication Onset Time (COT) and Quality of Life (QOL), as Measured Using the Walking Impairment Questionnaire (WIQ) and SF-36v2® at Days 90 and 180.||Day 0 to Days 90 and 180||||||
98998|NCT00822172|Secondary|The Combination of Cilostazol and L-carnitine on PWT Compared to Cilostazol Alone From Baseline/Day 0 to Day 90 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).||Day 0 to Day 90||||||
98999|NCT00822172|Primary|Safety of Combining Cilostazol With L-carnitine by Evaluating Laboratory Abnormalities and Adverse Events (AEs).||Day 0 to Day 210||||||
99000|NCT00822172|Primary|The Effect of Cilostazol Combined With L-carnitine on Change in Peak Walking Time (PWT) Compared to Cilostazol Alone From Baseline/Day 0 to Day 180 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).||Day 0 to Day 180|The mITT population included all randomized subjects who received at least 1 dose of study medication and completed at least 1 post randomization Exercise Treadmill Test (ETT).||minutes||Standard Deviation|Log Mean
99001|NCT00824005|Secondary|Reduction in Fixed Perfusion Defect(s)Via SPECT|Fixed total defect is the stress total defect minus the reversible component.|Measured at Baseline and Month 6|Only participants with both baseline and six month fixed defect data available are included.||percentage of defect that is fixed||Standard Deviation|Mean
99002|NCT00824005|Secondary|Incidence of a Major Adverse Cardiac Event|"Incidence of major adverse cardiac events (new MI, rehospitalization for PCI in coronary artery territories that were treated, death, or rehospitalization for acute coronary syndrome and for congestive heart failure).~(Incidence rate)"|Measured at Baseline and Month 6|Incidence of major adverse cardiac events between baseline and 6 months. (Incidence rate)||events|||Number
99003|NCT00824005|Secondary|LV Diastolic Dimension|Left ventricular (LV) diastolic dimension as assessed by contrast echocardiography|Measured at Baseline and Month 6|Only participants with both baseline and six month LV diastolic data available are included.||mL||Standard Deviation|Mean
99004|NCT00824005|Secondary|Serum BNP Levels in Patients With CHF|Serum b-type natriuretic peptide (BNP) levels in patients with congestive heart failure (CHF). A minority number of patients had pro-BNP collected versus regular BNP; these numbers are reported in the analysis population description.|Measured at Baseline and Month 6|Only participants with both baseline and six month BNP data available are included.||IUs||Standard Deviation|Mean
99005|NCT00824005|Secondary|Exercise Time and Level|Exercise time and level as assessed via six minute walk test. (change in number of feet walked)|Measured at Baseline and Month 6|Only participants with both baseline and six month 6 minute walk data available are included.||feet||Standard Deviation|Mean
99006|NCT00824005|Secondary|Number of Participants With a Decrease in Anti-anginal Medication|Number of participants with a decrease in anti-anginal medication (nitrates needed weekly)|Measured at Baseline and Month 6|Only participants with both baseline and six month anti-anginal medication data available are included.||participants|||Number
99007|NCT00824005|Secondary|Clinical Improvement in NYHA Classification|"Clinical improvement in New York Heart Association (NYHA) classification. The NYHA scale ranges from 1 (best)Mild- no limitation of physical activity due to heart failure to 4 (worst) Severe-Unable to carry out any physical activity without discomfort due to heart failure. Patients receive a rating of 1-4 for their heart failure symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month NYHA class data available are included.||units on a scale||Standard Deviation|Mean
99008|NCT00824005|Secondary|Clinical Improvement in CCS Classification (Angina Pectoris)|"Clinical improvement in Canadian Cardiovascular Society (CCS) functional classification of angina pectoris. The CCS scale ranges from Class I (best)able to conduct ordinary daily activity without causing angina to Class IV (worst) Inability to perform any physical activity without discomfort; anginal symptoms may be present at rest. Patients receive a rating of 1-4 for their anginal symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month CCS data available are included.||units on a scale||Standard Deviation|Mean
99009|NCT00824005|Secondary|Regional Wall Motion by Echocardiography|Movement of the left ventricular wall measured in mm from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and six month wall motion data available are included.||mm||Standard Deviation|Mean
99010|NCT00824005|Secondary|Regional Blood Flow Improvement by MRI (in Eligible Patients)|Regional blood flow improvement as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.|||||
99011|NCT00824005|Secondary|Regional Wall Motion by MRI (in Eligible Patients)|Regional wall motion as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.|||||
99012|NCT00824005|Primary|Change in Reversible Defect Size|Adenosine myocardial perfusion (SPECT) tests were collected at baseline and 6 months to identify change in ischemic (reversible) defects. SPECT imaging was performed at rest and after adenosine infusion over 4 minutes. To enhance the detection of viability on resting images, sublingual nitroglycerin was administered 15 minutes before injecting technetium Tc 99m sestamibi for the resting image.|Measured at Baseline and Month 6|Only participants with both baseline and six month reversible defect data available are included.||percentage of reversible defect||Standard Deviation|Mean
99013|NCT00824005|Primary|Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo|Echocardiographic measurements were performed by an echocardiographic core laboratory. LVESVs were calculated by the modified biplane Simpson method, using myocardial contrast to enhance endocardial definition. To account for patient body surface area, LVESV indices are reported.|Measured at Baseline and Month 6|Only participants with both baseline and six month LVESV data available are included.||mL/m2||Standard Deviation|Mean
99014|NCT00824005|Primary|Change in Maximal Oxygen Consumption (VO2max)|The VO2(max) is assessed using the Naughton treadmill protocol.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month VO2max data available are included.||mL/kg/min||Standard Deviation|Mean
99015|NCT00823979|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, the ability to interpret the pharmacokinetic/pharmacodynamic (PK/PD) results was limited, thus the data was not reported.|||||
99016|NCT00823979|Secondary|Population Pharmacokinetics (PK) of Lersivirine|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48||||||
99017|NCT00823979|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included blood chemistry, hematology and urinalysis.|Baseline up to Week 48 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
99018|NCT00823979|Secondary|Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48|Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load >500 copies/mL at treatment failure, up to Week 48.|Baseline through Week 48|Virology analysis set included a subset of participants from TLOVR50 failures who had valid genotypic or phenotypic susceptibility testing result and with plasma HIV-1 RNA >500 copies/mL at baseline and treatment failure.||participants|||Number
99019|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.||percentage of total lymphocytes||Standard Deviation|Mean
99020|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.||cells per microliter (cells/mcL)||Standard Deviation|Mean
99021|NCT00823979|Secondary|Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response (50 denotes lower limit of quantification [LLOQ] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure [TF] criteria). TF: an increase of at least (>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL); HIV-1 RNA <1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement >=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT.Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24,48 weeks were considered to have plasma HIV-1 RNA>=50 copies/mL;were referred as failure. Due to early termination of study,decision was made not to derive TLOVR50 responder analysis for Week 96.||percentage of participants|||Number
99094|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts|Thrombocytopenia is defined as an abnormal decrease in the number of platelets in circulatory blood. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population||participants|||Number
99022|NCT00823979|Secondary|Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as (area under the curve of HIV-1 RNA levels [log10 copies/mL] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.|Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: TAD imputed as zero; not discontinued but observation was missing at visit: TAD to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: TAD imputed as zero.||log10 copies/mL||Standard Deviation|Mean
99023|NCT00823979|Secondary|Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.||log10 copies/mL||Standard Deviation|Mean
99024|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24, 48, 96|ITT population. Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24, 48, 96 weeks were considered to have plasma HIV-1 RNA >=400 copies/mL and referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.||percentage of participants|||Number
99025|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Weeks 48, 96|ITT population. Participants who died, discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 48, 96 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.||percentage of participants|||Number
99026|NCT00823979|Primary|Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24|ITT population. Participants who died, discontinued, lost to follow-up, switched/changed dose of anti-retro viral (ARV) drug not allowed by protocol, had missing plasma HIV-1 RNA data at 24 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure.||percentage of participants|||Number
99027|NCT00823966|Primary|Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).|"Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.~Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.~Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category."|One year|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.||participants|||Number
99028|NCT00823966|Primary|Number of Participants Who Reported Unlisted Adverse Drug Reaction.|Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).|One Year|The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate.||participants|||Number
99029|NCT00823901|Primary|Mean Change in Number of Inflammatory Lesions From Baseline to Week 12|The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.|Baseline, week 12|Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used.||lesions||Standard Deviation|Mean
99030|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 54) was the event, and participants who had completed the study were censored.|0-385 days (up to Week 54)|Long-FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
99031|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."||participants|||Number
99050|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
99032|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||participants|||Number
99033|NCT00823836|Secondary|Mean Change From Week 0 in Awake Time Spent “On” With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at Week 54 minus On time with troublesome dyskinesias (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||hours||Standard Deviation|Mean
99034|NCT00823836|Secondary|Mean Change From Week 0 in Percentage of Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at Week 54 minus Off time (proportion) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of time||Standard Deviation|Mean
99035|NCT00823836|Secondary|Mean Change From Week 0 in Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at Week 54 minus Off time (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||hours||Standard Deviation|Mean
99036|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on percent change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
99037|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
99038|NCT00823836|Secondary|Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The CGI-I assesses the participant's improvement or worsening of PD from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|Week 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
99039|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
99040|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
99092|NCT00823823|Secondary|Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations|The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.|Up to 4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.||participants|||Number
99041|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."||scores on a scale||Standard Deviation|Mean
99042|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
99043|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.||scores on a scale||Standard Deviation|Mean
99044|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99045|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99046|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis."||scores on a scale||Standard Deviation|Mean
99047|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99048|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99049|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 (Baseline) in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score.|Week 54|Long-FAS: participants who were included in the FAS and entered into the Long-term Phase. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.||percentage of participants|||Number
99051|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
99052|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||participants|||Number
99053|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||participants|||Number
99054|NCT00823836|Secondary|Mean Change From Week 24 in Awake Time Spent “On” With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 24 on On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 24. Participants who had 0 hour as On time with troublesome dyskinesias at Week 24 were excluded from the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were also not included in the analysis.||hours||Standard Deviation|Mean
99055|NCT00823836|Secondary|Mean Change From Week 24 in Percentage of Awake Time Spent “Off” at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 24 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.||percentage of time||Standard Deviation|Mean
99056|NCT00823836|Secondary|Mean Change From Week 24 in Awake Time Spent “Off” at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 24 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.||hours||Standard Deviation|Mean
99057|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99058|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99059|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99060|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99061|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99062|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99063|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99064|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at Off) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is where PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|"Switching-FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values."||scores on a scale||Standard Deviation|Mean
99065|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at On) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99066|NCT00823836|Secondary|Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS: participants who were included in the FAS and progressed to the PR/XR Switching Phase. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.||scores on a scale||Standard Deviation|Mean
99067|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
99068|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.||percentage of participants|||Number
99069|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."||participants|||Number
99070|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||participants|||Number
99071|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On time with troublesome dyskinesias is measured as a proportion using the following formula: (Sum of two days On time with troublesome dyskinesias [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time with troublesome dyskinesias is measured using the following formula: On time with troublesome dyskinesias (proportion) at FAP minus On time with troublesome dyskinesias (proportion) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of time||Standard Deviation|Mean
99072|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||hours||Standard Deviation|Mean
99073|NCT00823836|Secondary|Mean Change From Week 0 in Percentage of Awake Time Spent “On” at FAP (up to Week 24) in the Non-Inferiority Verification Phase|"On state is defined as the state at which PD symptoms are well controlled by the drug. On time is measured as a proportion using the following formula: (Sum of two days On time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time is measured using the following formula: On time (proportion) at FAP minus On time (proportion) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of time||Standard Deviation|Mean
99074|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Mean Change from Week 0 in On time (actual hours) was calculated as On time (hours) at FAP minus On time (hours) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||hours||Standard Deviation|Mean
99093|NCT00823823|Primary|Loss of Radius Fracture Reduction|The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.|4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.||participants|||Number
99412|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 24 for On-ART Participants|Results reported are for HIV-1 RNA at week 24 for on-ART participants.|At week 24|Analysis is based on all on-ART participants with HIV-1 RNA data at week 24.||participants|||Number
99075|NCT00823836|Secondary|"Mean Percent Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Percent change from Week 0 in Off time (proportion) is measured using the following formula: (Change from Week 0 in Off time [proportion]/Off time [proportion] at Week 0) x 100."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percent change||Standard Deviation|Mean
99076|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of time||Standard Deviation|Mean
99077|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||hours||Standard Deviation|Mean
99078|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in percent change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of participants|||Number
99079|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of participants|||Number
99080|NCT00823836|Secondary|Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The CGI-I assesses the participant's improvement or worsening of PD from Baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.||percentage of participants|||Number
99081|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99082|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99083|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."||scores on a scale||Standard Deviation|Mean
99413|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 12 for On-ART Participants|Results reported are for HIV-1 RNA at week 12 for on-ART participants.|At week 12|Analysis is based on all on-ART participants with HIV-1 RNA data at week 12.||participants|||Number
99084|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99085|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.||scores on a scale||Standard Deviation|Mean
99086|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part IV total score were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99087|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 24 in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Particpants with only one observation for the part II (at Off) total score were not included in the analysis."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had Off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis."||scores on a scale||Standard Deviation|Mean
99088|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the score at Week 0."|Week 0 and FAP (up to Week 24)|"FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part II (at On) total score were not included in the analysis."||scores on a scale||Standard Deviation|Mean
99089|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part I total score were not included in the analysis.||scores on a scale||Standard Deviation|Mean
99090|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one measurement for the part III total score were not included in the analysis.|FAP (up to Week 24)|FAS: participants who were progressed to the Non-Inferiority Verification Phase but excluding those who did not have the target indication, those who had not received at least one dose of investigational product, and those whose measured data in efficacy were not available after treatment initiation.||percentage of participants|||Number
99091|NCT00823836|Primary|Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.|Week 0 and FAP (up to Week 24)|Per Protocol Set (PPS): participants with exclusion from the Full Analysis Set (FAS) of those violating the study protocol and assessed to be excluded from the assessment of drug efficacy. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2.||scores on a scale||Standard Deviation|Mean
99095|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts|Anaemia is defined as a pathological deficiency in the oxygen-carrying component of the blood, measured in unit volume concentrations of hemoglobin, red blood-cell volume, or red blood-cell number. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population||participants|||Number
99096|NCT00823719|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia|Neutropenia is defined as an abnormal decrease in the number of neutrophils (type of white blood cell in blood) in the blood. Febrile neutropenia is the development of fever in participants with neutropenia. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population||participants|||Number
99097|NCT00823719|Secondary|Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|Human anti-human antibodies (HAHA) indicate immune response to the administered human monoclonal antibody in a two-step assay. A positive screening result is confirmed in a second step. Negative Conclusive is subset of Negative and is a negative HAHA test result with an ofatumumab concentration <200 µg/mL in a pharmacokinetic sample collected at the same time as the HAHA sample. Data are presented when a HAHA sample was collected. WD, withdrawal; FU, follow up.|Study Day 1 up to approximately Study Day 63|Safety Population. Data are presented for those participants who contributed a sample.||participants|||Number
99098|NCT00823719|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Vss is the apparent volume of distribution when plasma concentrations are measured under steady state conditions. At steady state, the plasma concentration-time profile of the drug is similar after each dose.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population||Liters||Geometric Coefficient of Variation|Geometric Mean
99099|NCT00823719|Secondary|Terminal Phase Half-life (t1/2) of Ofatumumab|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population||hr||Geometric Coefficient of Variation|Geometric Mean
99100|NCT00823719|Secondary|Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3)|Ctrough is defined as the trough plasma concentration, which is the measured concentration at the end of a dosing interval (taken directly before the start of the next infusion).|Cycle 1 Day 8 (Study Day 8; up to 8 hours prior to infusion start), Cycle 2 (Study Day 22; up to 7 hours prior to infusion start), Cycle 3 (Study Day 43; up to 6 hours prior to infusion start)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
99101|NCT00823719|Secondary|Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3)|Cmax is defined as the maximum concentration of drug in plasma samples for the dosing occasion.|Cycle 1 Day 1 (Study Day 1; up to 48 hours), Cycle 1 Day 8 (Study Day 8; up to 24 hours), Cycle 3 (Study Day 43; up to 48 hours)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
99102|NCT00823719|Secondary|Clearance (CL) of Ofatumumab|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population||mL/hr||Geometric Coefficient of Variation|Geometric Mean
99103|NCT00823719|Secondary|Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3)|AUC(0-tau) is the area under the plasma concentration-time curve from time zero (0) over the dosing interval, tau, and is a measure of drug exposure. Tau is 21 days (504 hours) in this study.|Cycle 3 (Study Day 43; 3 weeks)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
99104|NCT00823719|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3)|AUC is defined as the area under the ofatumumab (Ofa) concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinite time. Results are reported by first dose group and combined, as appropriate.|Cycle 1 Day 1 (Study Day 1; up to 1 week) and Cycle 3 (Study Day 43; up to 6 weeks)|Pharmacokinetic Population: all participants (par.) exposed to ofatumumab from whom a pharmacokinetic sample was obtained and analyzed. Data for par. who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the par. attending each visit.||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
99105|NCT00823719|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of treatment start and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population||days||95% Confidence Interval|Median
99106|NCT00823719|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of treatment start and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments locally by investigators for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed).|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population||days||95% Confidence Interval|Median
99107|NCT00823719|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram (kg) From Peripheral Blood|CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization was defined as the collection of >2x10^6 CD34+ cells/kg. Only those participants, who commenced mobilization, following the administration of ofatumumab in combination with either ICE or DHAP combination chemotherapy, were assessed.|During treatment Cycle 2 (Study Days 22-42) and/or Cycle 3 (Study Days 43-63)|Stem Cell Mobilization Population. All participants in the PP Population in whom stem cell mobilization was attempted and CD34+ cell data are available.||participants|||Number
99108|NCT00823719|Secondary|Number of Participants With CR, as Assessed by the Investigator|CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population||participants|||Number
99109|NCT00823719|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|Per protocol (PP) Population: all participants who received at least one dose of ofatumumab. Participants with major protocol deviations that could have impacted the efficacy outcome, and participants not exposed to ofatumumab or without CD20+ aggressive lymphoma were excluded from assessment. CD, cluster of differentiation.||participants|||Number
99110|NCT00823615|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|Tested while reading charts at 40 cm with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||LogMAR||Standard Deviation|Mean
99111|NCT00823615|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.||LogMAR||Standard Deviation|Mean
99112|NCT00823472|Secondary|Number of Cumulus Oocyte Complexes Obtained||one year|||oocytes||Standard Deviation|Mean
99113|NCT00823472|Primary|Proportion of Top Embryos Per OPU.||1 year|ITT||percentage embryos|||Number
99114|NCT00823303|Primary|Confirmed Hypercalcemia|Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.|24 week treatment period|||participants|||Number
99115|NCT00823212|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Acute-At time of index procedure|Analysis was intention to treat (all patients in the study).||percentage of stents|Participants||Number
99116|NCT00823212|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death|In hospital|Analysis was intention to treat (all patients in study).||percentage of participants|||Number
99117|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99118|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99119|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99120|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99132|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99121|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99122|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99123|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99124|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99125|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99126|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99127|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99128|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99129|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99130|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99131|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
102272|NCT00795951|Primary|Diagnostic Performance: Epoxy Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
99133|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99134|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99135|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99136|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99137|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99138|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99139|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99140|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99141|NCT00823212|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99142|NCT00823212|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99143|NCT00823212|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of patients|||Number
99144|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99145|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99165|NCT00823082|Secondary|Postoperative Blood Loss in First 12 Hours|Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours|ICU admission through 12 hours post-operative|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.||mL||Standard Error|Least Squares Mean
99146|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99147|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99148|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99149|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99150|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99151|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
99152|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.||Percentage of participants|||Number
99153|NCT00823212|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12-month post index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.||percentage of participants|||Number
99154|NCT00823199|Post-Hoc|Uric Acid Level||Baseline to 4 weeks|2 subjects had missing data||mg/dL||Standard Deviation|Mean
99155|NCT00823199|Secondary|Simpson Angus Scale for Parkinsonism|Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)|baseline and 4 weeks|||score on scale||Standard Deviation|Mean
99156|NCT00823199|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia|Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)|baseline and 4 weeks|Two subjects withdrew before the first week's evaluation||scores on a scale||Standard Deviation|Mean
99157|NCT00823095|Secondary|The Secondary Endpoint Measure is a Reduction on Wound Size.|reduction in bioburden as assessed by number of cfu's per cm2 on culture|28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform analysis.|||||
99158|NCT00823095|Primary|The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.||at 28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform study analysis|||||
99159|NCT00823082|Secondary|Length of Hospital Stay|Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.|During ICU stay (maximum 70 days)|||days||Inter-Quartile Range|Median
99160|NCT00823082|Secondary|Mechanical Ventilation Duration||During ICU stay (maximum 70 days)|Intent-to-treat set||Days||Inter-Quartile Range|Median
99161|NCT00823082|Secondary|Percentage of Subjects With Renal Dysfunction|Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to >2.0 and twice the baseline level or need for renal replacement therapy|During ICU stay (maximum 70 days)|Intent-to-treat set||Percentage of participants|||Number
99162|NCT00823082|Secondary|Percentage of Subjects With Low Cardiac Syndrome|Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump|During ICU stay (maximum 70 days)|Intent-to-treat set. Three subjects in the Antithrombin III treatment group and 1 subject in the Control group were missing this data.||percentage of participants|||Number
99163|NCT00823082|Secondary|Percentage of Subjects Needing Surgical Re-exploration|Percentage of subjects needing surgical re-exploration resulting from bleeding|During ICU stay (maximum 70 days)|Intent-to-treat set. Two subjects in the Antithrombin III treatment group and 2 subjects in the Control group were missing this data.||percentage of participants|||Number
99164|NCT00823082|Secondary|Need for Blood Products|Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed|During ICU stay (maximum 70 days)|Intent-to-treat set||Units||Standard Error|Least Squares Mean
99166|NCT00823082|Secondary|Heparin Resistance|Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time >450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses|Immediately after anesthesia induction|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.||percentage of participants|||Number
99167|NCT00823082|Secondary|In-hospital Postoperative Mortality||70 days after ICU admission (maximum)|Intent-to-treat set. One subject in the control group was missing this data.||percentage of participants|||Number
99168|NCT00823082|Secondary|ICU Stay Duration||During ICU stay (maximum 70 days)|Intent-to-treat set. One subject in the control group was missing this data.||days||Inter-Quartile Range|Median
99169|NCT00823082|Secondary|Percentage of Patients With Thromboembolic Events|Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism|During ICU stay (maximum 70 days)|Intent-to-treat set||percentage of participants|||Number
99170|NCT00823082|Secondary|Percentage of Subjects With Adverse Neurologic Outcome|Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation|During ICU stay (maximum 70 days)|Intent-to-treat set||percentage of participants|||Number
99171|NCT00823082|Secondary|Percentage of Subjects With Postoperative Myocardial Infarction|Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram|During ICU stay (maximum 70 days)|Intent-to-treat set||percentage of participants|||Number
99172|NCT00823082|Primary|Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission|Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission|ICU admission|Intent-to treat set and Per-protocol set||percentage of participants|||Number
99173|NCT00823082|Primary|Postoperative ATIII Levels at the ICU Admission|Measurement of postoperative ATIII functional activity at ICU admission|ICU admission|Intent-to-treat set and Per-protocol set||IU||Standard Deviation|Mean
99174|NCT00823069|Secondary|Number of Subjects Showing Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline|||Participants|||Number
99175|NCT00823069|Primary|Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm||After Injection on Day of Treatment|This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark.||Participants||95% Confidence Interval|Number
99176|NCT00823043|Primary|Subject Reported Blurred Vision|Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|||Units on a Scale||Standard Deviation|Mean
99177|NCT00823043|Primary|Subject Reported Light Sensitivity|Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|Analysis includes all subjects that answered this question. One subject from each arm did not answer this question.||Units on a Scale||Standard Deviation|Mean
99178|NCT00823043|Primary|Subject Reported Tearing|Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation.|||Units on a Scale||Standard Deviation|Mean
99179|NCT00823043|Primary|Subject Reported Burning/Stinging|Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|||Units on a Scale||Standard Deviation|Mean
99180|NCT00822900|Secondary|Potentially Associated Adverse Events: Myocardial Infarction (MI)|Myocardial infarction - Events were defined based on serial cardiac enzyme elevation consistent with MI and/or new ST elevation on electrocardiogram (ECG) consistent with MI. Potentially associated adverse events (those events which are included as outcome measures) were specifically defined per the protocol, and the classification of an event as a PAAE was determined by the site. The reported name of the associated event, however, was subject to clinical judgement and case details; these were then further coded by the Principal Investigator. Since these data points do not share the same definition, there is no reason to expect perfect concordance. (For example, the potentially associated adverse event of myocardial infarction may include MedDRA codes other than myocardial infarction.)|within 6 months|||participants|||Number
99181|NCT00822900|Secondary|Potentially Associated Adverse Events: Central Nervous System (CNS) Infection|CNS infection - Events must have met Centers for Disease Control and Prevention (CDC) definition of CNS infection. The definition includes intracranial infection, Meningitis, ventriculitis, and spinal abscess without meningitis.|within 6 months|||participants|||Number
99182|NCT00822900|Secondary|Potentially Associated Adverse Events: Pneumonia|Events must have met Centers for Disease Control and Prevention (CDC) definition of pneumonia. There are three specific types of pneumonia: clinically defined pneumonia, pneumonia with specific laboratory findings, and pneumonia in immunocompromised patients. There are specific algorithms to identify each pneumonia, which include x-ray findings, fever with no other cause, leukopenia or leukocytosis, altered mental status with no other cause (adults >70 years old), new onset of purulent sputum, change in character of sputum, increase respiratory secretions, increase suctioning requirements, new onset or worsening cough, dyspnea, tachypnea, rales, bronchial breath sounds, or worsening gas exchange, increased oxygen requirements, or increased ventilator demand). Also, labs can identify pneumonia such as positive growth in blood culture, positive Gram stain, and histopathologic exam evidence.|within 6 months|||participants|||Number
99222|NCT00822510|Primary|Negative Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
99183|NCT00822900|Secondary|Potentially Associated Adverse Events: Sepsis|Sepsis - Events must have met Centers for Disease Control and Prevention (CDC) definition of sepsis. The definition includes that a patient ≤1 year of age has at least 1 of the following clinical signs or symptoms with no other recognized cause: fever (>38°C rectal), hypothermia (<37°C rectal), apnea, or bradycardia, and blood culture not done or no organisms detected in blood and no apparent infection at another site and physician institutes treatment for sepsis.|within 6 months|||participants|||Number
99184|NCT00822900|Secondary|Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level|Unexplained increased liver enzymes (e.g. not due to liver injury ) - Events were defined based on aspartate transaminase (AST) and alanine transaminase (ALT) levels > 500 U/L and/or total bilirubin levels > 2.0 mg/dL.|within 6 months|||participants|||Number
99185|NCT00822900|Secondary|Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)|DVT - Events were defined based on a positive Doppler ultrasound exam|within 6 months|||participants|||Number
99186|NCT00822900|Secondary|Potentially Associated Adverse Events: Acute Ischemic Stroke|Acute ischemic stroke - Events were defined based on either positive computed tomography (CT) scanning, magnetic resonance imaging (MRI), or neurologist diagnosis of cerebrovascular accident (CVA)|within 6 months|||participants|||Number
99187|NCT00822900|Secondary|Potentially Associated Adverse Events: Pulmonary Embolism|Pulmonary embolism - Events were defined based on either positive chest computed tomography (CT) scanning or ventilation/perfusion lung scan (V/Q).|within 6 months|||participants|||Number
99188|NCT00822900|Secondary|Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis|Phlebitis/Thrombophlebitis (not due to infiltration or misplacement of the IV)|within 6 months|||participants|||Number
99189|NCT00822900|Secondary|Disability Rating Scale|A measure of functional impairment, with complete recovery scored a 0 and vegetative state scored a 29.|6 months|||units on a scale||Standard Deviation|Mean
99190|NCT00822900|Secondary|Mortality||6 months|||participants|||Number
99191|NCT00822900|Primary|Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)|A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.|6 months post randomization|The primary analysis was conducted according to intention to treat.||participants|||Number
99192|NCT00822770|Secondary|Response Rate (Engraftment Versus Graft Failure)|Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.|100 Days post engraftment||||||
99193|NCT00822770|Secondary|Time to Failure|Time to treatment failure defined as either disease recurrence or death, measured in months.|Baseline till disease progression/death, up to 1 year.||||||
99194|NCT00822770|Primary|Maximum Tolerated Dose (MTD) Plerixafor|MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).|28 day cycle (Plerixafor Day -7 to Day -4)|||mg/kg|||Number
99195|NCT00822757|Other Pre-specified|GMFR in Antibody Concentration From Baseline|An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.|Prevaccination to Days 10, 14, 28, and 84 postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
99196|NCT00822757|Other Pre-specified|GMFR by Age|Participants whose geometric mean fold–rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.|Prevaccination to 14 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
99197|NCT00822757|Primary|Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).|Participants whose geometric mean fold–rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).|Prevaccination to 14 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
99198|NCT00822692|Primary|Recurrence Rates of Abscesses|Number of patient with a new abscess in same or different location as previous lesion|30 days after incision and drainage|||participants|||Number
99199|NCT00822679|Secondary|Changes in Objective and Subjective Measures of Sleep||4 days||||||
99200|NCT00822679|Primary|Changes in Circulating Inflammatory Cytokines (Interleukin [IL]-1B, IL-6, IL-10, and Tumor Necrosis Alpha [TNF-α]) and Pro-coagulant Mediators (Soluble P-selectin and CD40 Ligand).|Not performed. Zero subjects were randomized. Many potential participants screen-failed.|2 days|Not performed. Zero subjects were randomized. Many potential participants screen-failed.|||||
99201|NCT00822588|Primary|Number of Participants in Need for Bank Blood Transfusion|"Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared.~The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)"|At discharge|Per protocol group. Major protocol deviations were excluded: Incorrect treatment, no treatment or exclusion criteria fulfilled.||Participants|||Number
99202|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99203|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99204|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99205|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99206|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99223|NCT00822510|Primary|Positive Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
99207|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99208|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99209|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99210|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99211|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99224|NCT00822510|Primary|Perceived Stress|Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
99414|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for On-ART Participants|Results reported are for HIV-1 RNA at study entry for on-ART participants.|At Entry|Analysis is based on all on-ART participants with HIV-1 RNA data at entry.||participants|||Number
99212|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99213|NCT00822523|Secondary|Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB.|Measure the percent change of the Surface Electromyogram (SEMG) as measured by the Mean Rectified Voltage (MRV) with a window of 500 ms from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A or placebo. Each MRV represents the mean of 3 individual measurements of the MRV at that timepoint with measurements at least 60 seconds apart. In order to facilitate comparison from one subject to the next, the MRV is then converted into percent change from baseline for that subject.|Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4|||percent change from baseline||Standard Deviation|Mean
99214|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.||percent change from baseline||Standard Deviation|Mean
99215|NCT00822523|Secondary|Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin)||At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4)|||participants|||Number
99216|NCT00822523|Secondary|Difference in Force From Day 14 to Day 21|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A). The force at each day of testing was the mean of the 3 values for force obtained on that day. Value is percent change from baseline. Comparison is made between the percent change from baseline force and the force on Day 14 in each group vs. the percent change from baseline force and the force on Day 21 in each group.|Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB.|||percent change from baseline||Standard Deviation|Mean
99217|NCT00822523|Secondary|Stability of Baseline Measurements of Force|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge on three different days prior to injection of BoNT/A or placebo. On each of the three days of baseline testing, the force was defined as the mean of three different measurements, separated by at least 1 minute from another measurement.|Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing)|Normal controls at baseline before BoNT/A injected||kg||Standard Deviation|Mean
99218|NCT00822523|Primary|"Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB"|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A) or placebo. The baseline value was the mean of the 3 values for force obtained prior to injection of BoNT/A. The baseline was compared with the subsequent values.|Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4|||kg||Standard Deviation|Mean
99219|NCT00822510|Primary|Spiritual Well Being|Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
99220|NCT00822510|Primary|Social Well Being|Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
99221|NCT00822510|Primary|Multidimensional Fatigue Inventory|Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)|||units on scale||Standard Deviation|Mean
103169|NCT00789724|Secondary|Difference Between the 2 Arms in the Percentage of Patients With Any of the Following : a) End-systolic or End-diastolic Volume Index Increase >10%; b) Ejection Fraction Decrease >10%; c) E/E'>15 at Follow up||10-14 weeks||||||
99225|NCT00822510|Primary|Center for Epidemiological Studies-Depression Scale|Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression.|3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks|Badger, T.A., Segrin, C., Figueredo, A.J., Harrington, J., Sheppard, K., Passalacqua, S., Pasvogel, A., & Bishop, M. (2011) Psychosocial Interventions to Improve Quality of Life in Prostate Cancer Survivors and their Intimate or Family Partners. Quality of Life Research. 20 (6), 833-844 [epub Dec 2010]. PMID: 21170682; PMCID: PMC3117079||units on scale||Standard Deviation|Mean
99226|NCT00822354|Primary|Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents no difficulty with Raynaud's disease, and 100 mm (right boundary) represents extreme difficulty with Raynaud's disease. The subject makes a vertical mark on the VAS to indicate difficulty experienced that day with Raynaud's disease. The RCS is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.||millimeters||Full Range|Median
99227|NCT00822354|Secondary|Capillary Diameter|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 8, Baseline/Week 0 data was used for both Pre-treatment and Pre-placebo, and Week 2 data was used for Week 4 of placebo.||micrometers||Full Range|Median
99228|NCT00822354|Secondary|Digital Blood Pressure|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 10, Week 2 data was used for Week 4 of placebo because digital blood pressure data was not obtained at the Week 4 visit.||mm Hg||Full Range|Median
99229|NCT00822354|Primary|Raynaud Severity Visual Analog Score (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents Raynaud's disease of low severity, and 100 mm (right boundary) represents extremely severe Raynaud's disease. The subject makes a vertical mark on the VAS to indicate the severity of Raynaud's disease over the past two weeks. The Raynaud's severity score is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.||millimeters||Full Range|Median
99230|NCT00822354|Primary|Duration of Raynaud's Phenomenon Attacks|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day and the duration of each attack. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.||minutes||Full Range|Median
99231|NCT00822354|Primary|Number of Raynaud's Phenomenon Attacks Per Day|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.||Raynaud's attacks per day||Full Range|Median
99232|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.~Clostridium perfringens was cultured.Bacterial colonies were counted."|week 0, 1, 2, 3, 4, 5, 6.|||log10 CFU/g||Standard Deviation|Log Mean
99234|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Bifidobacterium|Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.|week 0, 1, 2, 3, 4, 5, 6.|The number of participants for analysis was per protocol analysis.||log10 CFU/g||Standard Deviation|Log Mean
99235|NCT00822237|Primary|Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).|"Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL.~Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only."|6 weeks following first vaccination|Per protocol population||Percent of participants|||Number
99236|NCT00821951|Secondary|Vorinostat Modification of the DNA Damage Response in Patient Samples||1 Year||||||
99237|NCT00821951|Secondary|Target Lesion Response||1 Year||||||
99238|NCT00821951|Primary|The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation.|maximum tolerated dose of vorinostat when given concurrently with radiation|1 Year|All participants who received any drug||mg|||Number
99239|NCT00821886|Secondary|Overall Survival|Defined as the time between Day 1 Cycle 1 to date of death from any cause.|approximately 48 months|||months||95% Confidence Interval|Number
99240|NCT00821886|Secondary|Disease-free Survival|Defined as the interval from the first date of study treatment until the date of tumor recurrence or death from any cause|expected average 18 months|||months||95% Confidence Interval|Median
99241|NCT00821886|Secondary|Number of Subjects With Adverse Events as a Measure of Safety and Toxicity|Assessment based on the frequency of treatment-related adverse events according to NCI CTCAE criteria v3.0.|Day 1 of each 3 week cycle up to 6 cycles , and every 9 weeks post-surgery until treatment discontinuation|Includes eligible patients||participants|||Number
99242|NCT00821886|Primary|Pathologic Complete Response (pCR)|Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery|average18 months|Patients who underwent surgery per protocol||participants|||Number
99243|NCT00821873|Primary|MRI to Evaluate Success of Outcome.|"The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.~The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score."|24 months|||units on a scale||Standard Deviation|Mean
99244|NCT00821821|Secondary|mRS, NIHSS, Barthel Index||throughout study||||||
99245|NCT00821821|Secondary|Plasma MCI-186 Pharmacokinetics|The geometric mean values of MCI-186 plasma concentration at the end of the infusion (at 72h) in cohorts 1 and 2 were determined.|72 hours|The subjects with reliable measured values for plasma concentration were selected for pharmacokinetic analysis: 5 subjects in MCI-186 Cohort 1 and 11 subjects in MCI-186 Cohort 2.||ng / ml||Geometric Coefficient of Variation|Geometric Mean
99246|NCT00821821|Primary|Number of Participants That Experienced Adverse Events|Additional Outcome Measures are included in Tables for Serious Adverse Events and Other Adverse Events to report their numbers and frequency.|87days|||participants|||Number
99247|NCT00821678|Secondary|Received at Least 8 Sessions of Exposure Based Therapy|0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy|12 months|||participants|||Number
99248|NCT00821678|Secondary|Medication Adherence, Defined as Taking Medication <80% of Days|0 - taking medication <80% of days; 1 - taking medications >=80%|6 months|||participants|||Number
99249|NCT00821678|Secondary|Satisfaction With Care (ECHO)||6 months||12/2016||||
99250|NCT00821678|Secondary|Change in Continuous Measure of Quality of Life (QWB)|range - 0-1 (higher score represents greater wellbeing)|6 months||12/2016||||
99251|NCT00821678|Secondary|Change in Continuous Measure of Health Status (SF12V PCS)|range - 0-100 (higher score represents greater physical health status)|6 months|||units on a scale||Standard Deviation|Mean
99252|NCT00821678|Secondary|Change in Continuous Measure of Alcohol Use (Audit Score)|range - 0-12 (higher score represents greater severity)|6 months|||units on a scale||Standard Deviation|Mean
99253|NCT00821678|Secondary|Change in Continuous Measure of Depression Symptom Severity (SCL-20)|range - 0-4 (higher score represents greater severity|6 months|||units on a scale||Standard Deviation|Mean
99254|NCT00821678|Primary|Change in PTSD Symptom Severity (PDS)|range - 0-51 (higher score represents greater severity)|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
99255|NCT00821587|Primary|Hepatitis C Viral Level|Undetectable or <100 COPIES/ML|6 months after completion of interferon based therapy|Randomization was performed using computer-generated random numbers. 150 patients were eligible and 39 met entry criteria for enrollment in the study. Subjects with HCV recurrence (Ishak Stage2) were randomized to TAC or to change to CsA before initiation of therapy with PEGa-2a and ribavirin for 48 weeks for genotype-1,or 24 weeks for genotype-3.||Participants|||Number
99256|NCT00821509|Primary|Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI). Individual weekly reports were combined in a single continuum and successive days with either RTI or GTI symptoms were designated as disease episodes due. Numbers of RTI, GTI and either episodes in each trial arm were calculated, and for the respective proportion, were divided by the total number of weekly reports collected in the arm.|At the end of the study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants||Disease episodes|Participants||Number
99332|NCT00819156|Secondary|Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28|Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.|Day 28 - 364|ITT population of patients with testoterone measurements <=0.5 nanogram/milliliter at Day 28.||participants|||Number
99257|NCT00821509|Primary|Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI) as well as whether they were working (if expected) or not, daily for the previous calendar week. Individual weekly reports were combined in a single continuum and successive days with both symptoms and absence from work were designated as days-off episodes due to own infectious disease. Number of these episodes in each trial arm was calculated and for the respective proportion, was divided by the total number of weekly reports collected in the arm.|At the end of the entire study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants||sick-leave episodes|Participants||Number
99258|NCT00821431|Secondary|Healing Measured by Number of Subjects Healed During the 12 Week Study Period||12 weeks|||Number of subjects healed|||Number
99259|NCT00821431|Primary|Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)||12 Weeks|||Number of Subjects with Adverse Events|||Number
99260|NCT00821327|Secondary|Ovarall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population||months||95% Confidence Interval|Median
99261|NCT00821327|Secondary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."|2 years|ITT population||Month||Full Range|Median
99262|NCT00821327|Primary|Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|All eligible patients who meet the protocol-specified efficacy analyses requirements and who have received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
99263|NCT00821236|Primary|1 Month Postoperative Lasik Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Month Postoperative|||LogMar||Standard Deviation|Mean
99264|NCT00821236|Primary|1 Week Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured withouth glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 week post op|||LogMar||Standard Deviation|Mean
99265|NCT00821236|Primary|1 Day Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Day|||LogMar||Standard Deviation|Mean
99266|NCT00821184|Secondary|Improvement of Symptom Severity||3 months||||||
99267|NCT00821184|Primary|Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.||0 week - 12 weeks|||incontinence episodes per 24 hours||Full Range|Mean
99268|NCT00821119|Secondary|Bronchopulmonary Dysplasia|The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit.|at 36 weeks gestational age|The number of preterm infants surviving to 36 weeks postmenstrual age were eligible for analysis||participants|||Number
99269|NCT00821119|Primary|Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)|The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit|first 3 days of life(72hours)|We estimated a 20% absolute reduction in the need of using endotraqueal ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||participants|||Number
99270|NCT00821119|Primary|Need for Endotracheal Ventilation in the First 72 hs of Life|number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life|first 72 hs of life|40 - 45% of our previous preterm infants on NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||participants|||Number
99271|NCT00821093|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
99333|NCT00819156|Primary|Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364|Number of patients who achieved a testosterone level considered a castration level.|12 months|ITT population.||participants|||Number
99334|NCT00819910|Secondary|Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit|The mean Levels of AST and ALT measured at initial visit (Day 0) and final visit (Week 12) annotated as AST 1, AST 12, and ALT 1 and ALT 12, respectively.|12 weeks from initial visit (day 0) to final visit (12 weeks)|||mg/dl||Standard Deviation|Mean
99272|NCT00821093|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
99273|NCT00821041|Secondary|Beliefs and Attitudes About Sleep||6 weeks||||||
99274|NCT00821041|Secondary|Pre-Sleep Arousal|Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.|6 weeks|||PSA Scale||Standard Deviation|Mean
99275|NCT00821041|Primary|Sleep Quality|Sleep Quality was assessed by taking the average of two items: “How well do you feel this morning?” And “How enjoyable was your sleep last night?” (0 = not at all, 4 = very).|6 weeks|||0-4 scale of sleep quality||Standard Deviation|Mean
99276|NCT00820755|Primary|Percentage of Participants With 1-year Overall Survival|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier. Percentage of participants who were still alive until one year after the last participant was included (March 2010).|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until one year after the last participant was included (March 2010)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||percentage of participants||95% Confidence Interval|Number
99277|NCT00820755|Secondary|Percentage of Participants With Disease Control for the Whole Study Period|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed best overall response according to IRC assessment in combination therapy phase and radiological assessments (based on RECIST Version 1.0 criteria) in the maintenance therapy phase.|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||percentage of participants||95% Confidence Interval|Number
99278|NCT00820755|Secondary|Percentage of Participants With Disease Control in the Combination Therapy Phase|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed BOR according to IRC assessment.|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.||percentage of participants||95% Confidence Interval|Number
99279|NCT00820755|Secondary|Percentage of Participant With Best Unconfirmed Tumor Response for the Whole Study Period|The response rate is defined as the percentage of participants having achieved CR and PR as the BOR according to IRC assessment in combination therapy phase and radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) in the maintenance therapy phase. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||percentage of participants||95% Confidence Interval|Number
99280|NCT00820755|Secondary|Percentage of Participants With Best Unconfirmed Tumor Response in the Combination Therapy Phase|The response rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the unconfirmed best overall response (BOR) according to centrally reviewed investigator assessments based on an independent review charter (IRC). As per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.||percentage of participants||95% Confidence Interval|Number
99281|NCT00820755|Secondary|Time to Treatment Failure (From Randomization to Cetuximab Maintenance Regimen Until Death)|Time from randomization in cetuximab maintenance regimen to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of randomization (Day 1 of maintenance therapy) if they received no study drug.|Time from randomization in cetuximab maintenance regimen to treatment failure or last drug intake, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
99282|NCT00820755|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from trial inclusion to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of inclusion (Day 1) if they received no study drug.|Time from trial inclusion to treatment failure or last drug intake, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
99283|NCT00820755|Secondary|Overall Survival (OS) Time (From Randomization to Cetuximab Maintenance Regimen Until Death)|The OS time is defined as the time from randomization in cetuximab maintenance regimen to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization in cetuximab maintenance regimen to death or last day known to be alive, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
99284|NCT00820755|Primary|Overall Survival (OS) Time|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|Intention-to-treat (ITT) maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on computer tomography [CT] or magnetic resonance imaging [MRI] scan) by the Investigator and randomized to maintenance therapy.||months||95% Confidence Interval|Median
99285|NCT00820664|Secondary|Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo.||4 weeks||||||
99286|NCT00820664|Primary|Immunohistochemistry (IHC) Proliferative Effects Measurement|Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.|4 weeks|Though 29 subjects were enrolled, only 20 subjects had biopsy samples that were deemed adequate for Ki-67 immunohistochemical analysis at Week 4.||Square root of % positive stained cells||95% Confidence Interval|Least Squares Mean
99287|NCT00820612|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.|5 days|100% completed follow-up||participants|||Number
99288|NCT00820573|Secondary|Changes in Plasma Glucose Post-MTT After Each Six Weeks of Therapy Compared to Baseline|The absolute values of mean plasma glucose post-meal (360 minutes)were determined after each specific 6 week treatment and these absolute values after each specific sequence therapy were compared amongst all groups.|360 min|power calculation based on previous data||mg/dl||Standard Error|Mean
99289|NCT00820573|Primary|Average of Plasma Glucose During Mixed Meal Tolerance Test (MTT) Compared to Baseline Plasma Glucose to Post Therapy (6-weeks).|The degree of suppression of baseline endogenous glucose production was measured in absolute values and as a percent of basal values at the end of each 6-week therapeutic period. The absolute values obtained in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|power calculations with data from previous similar studies||mg/kg.min||Standard Error|Mean
99290|NCT00820573|Secondary|Fasting Plasma Glucose 6 Weeks After Therapy|Basal pasma glucose was determined with the glucose oxidase method after each specific 6 week treatment. The absolute values obtained of basal plasma glucose at the end of each 6-week therapeutic period in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|All 16 participants were analyzed using ANOVA to compare results after each 6 week period of exposure to therapeutic agent(s)||mg/dl||Standard Error|Mean
99291|NCT00820573|Primary|Objective: Comparisons of the Effects of Co-administration of Sitagliptin and Metformin Alone or in Combination Versus Placebo on Baseline Endogenous Glucose Production (EGP).|Baseline endogenous glucose production prior to a mixed meal tolerance test (placebo) and following 6 weeks of either sitagliptin, metformin or sitagliptin plus metformin combination therapy in all 16 participants|6 weeks|||mg/kg.min||Standard Error|Mean
99292|NCT00820534|Secondary|Size of the Cold Sore|The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.|72 hours|||square mm||95% Confidence Interval|Mean
99293|NCT00820534|Primary|Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.|Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).|72 hours|||participants|||Number
99335|NCT00819910|Secondary|Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels|Post-treatment median change in Apo AI, Apo AII and Apo CIII levels reported in mg/dL with Interquartile ranges provided|12 weeks from initial visit (day 0) to final visit (12 weeks)|||% Change||Inter-Quartile Range|Median
99336|NCT00819910|Secondary|Post-treatment Percent Change in Low-Density Lipoprotein (LDL) Levels|The reported percent change is the difference between LDL levels obtained on initial visit (day 0) and LDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|||% change||Standard Deviation|Mean
99294|NCT00820443|Secondary|Metal Ion Analysis; Unilateral Only; Serum Chromium|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.||ug/L||Standard Deviation|Mean
99295|NCT00820443|Secondary|Metal Ion Analysis (Unilateral Only):Serum Cobalt|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant.|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.||ug/L||Standard Deviation|Mean
99296|NCT00820443|Secondary|WOMAC Raw Total Score|The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96).|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 175 participants were evaluated at 24 months.||units on a scale||Standard Deviation|Mean
99297|NCT00820443|Secondary|The Secondary Measures of the UCLA Functional Assessments|"UCLA: University of California LosAngeles Activity Score~UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as “no physical activity” and 10 defined as “regular participation in impact sports”. The score is the higher the better."|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 177 participants were evaluated at 24 months.||units on a scale (10 points)||Standard Deviation|Mean
99298|NCT00820443|Primary|Primary Endpoint/Measures: Success at 24 Months|"The patient success definition is measured at the 24 month interval by the following:~Harris Hip Score (HHS) of > 80 • < 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain.~No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure.~A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure.~The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery"|24 Month|Patients with Harris Hip Score (HHS) of > 80 Because there isn't complete radiographic data,the composite primary outcome is not analyzed at 24 month as in protocol. Only the number of patients who has HHS score greater that 80 is entered.Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 197.||participants|||Number
99299|NCT00820222|Secondary|Number of Participants Expressing Glucocorticoid Receptor, Phosphatase and Tensin Homolog (PTEN), Phosphatidylinositide 3-kinase (PI3K)/AKT, Protein 53 (P53), Insulin-like Growth Factor-1 (IGF-1), and Genes Involved in Cell Cycle Regulation|Because the study terminated early, pharmacogenetic and biomarker analyses were not performed.|Baseline|ITT Population|||||
99300|NCT00820222|Secondary|Number of Participants With Qualitative and Quantitative Toxicities|"Qualitative and quantitative toxicities were measured as AEs. See the outcome measure entitled Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in >=2 participants in either treatment arm and the AE module of this results summary for a list of AEs occurring in the study. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment."|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)|Safety Population|||||
99301|NCT00820222|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2 Participants in Either Treatment Arm|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was related to study drug. AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE.|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)|Safety Population: all participants in the ITT Population who received at least one dose of investigational product, based on the actual treatment received if this differed from that to which the participant was randomized||participants|||Number
99415|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants.|At weeks 12 and 24|Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24.||log10 copies/mL||Inter-Quartile Range|Median
99302|NCT00820222|Secondary|Number of Participants With CNS Progression at Any Time|CNS progression was documented by a brain scan and was indicated by the investigator on the follow-up electronic Case Report Form. CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease, with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From the time of randomization until death due to any cause (average of 10 months)|M-ITT Population||participants|||Number
99303|NCT00820222|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) until the first documented sign of PD (at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions) or death due to breast cancer. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months)|ITT Population. Only those participants with CR or PR showing PD or death due to breast cancer were analyzed.||months||95% Confidence Interval|Median
99304|NCT00820222|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as the number of participants with evidence of confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD [defined as at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions] based on investigator assessment), for at least 24 weeks.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.||participants|||Number
99305|NCT00820222|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants with either a confirmed complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD). CR and PR were assessed per Response Evaluation Criteria in Solid Tumors (RECIST). To be assigned a status of PR or CR, a confirmatory disease assessment was to be performed 28 days (4 weeks) or greater after the criteria for response were first met. In addition, a bone scan must have been obtained to rule out the presence of new bone lesions or progression of existing bone lesions, even if the participant had no bone lesions present at Baseline. If a bone scan was performed at the time of initial response or near the time of response, the bone scan did not need to be repeated.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.||participants|||Number
99306|NCT00820222|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause or to the date of censor. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From randomization until death due to any cause (average of 10 months)|ITT Population||months||95% Confidence Interval|Median
99307|NCT00820222|Secondary|Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until the date of documented CNS progression (average of 10 months)|M-ITT Population. Only those participants who had no Baseline CNS metastases and who had CNS progression by radiographic confirmation (per Response Evaluation Criteria in Solid Tumors, 1.0: a 20% increase in the sum of the longest diameter [LD] of target lesions or the appearance of >=1 new lesions) were included in this analysis.||months||Standard Deviation|Mean
99308|NCT00820222|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), or death due to any cause. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions based on investigator assessment of both CNS and non-CNS for response.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered||months||95% Confidence Interval|Median
99337|NCT00819910|Secondary|Post-treatment Percent Change in High-Density Lipoprotein (HDL) Levels|The reported percent change is the difference between HDL levels obtained on initial visit (day 0) and HDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|||% change||Standard Deviation|Mean
99309|NCT00820222|Primary|Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|Modified Intent-to-Treat (M-ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered and who had no Baseline CNS metastases per Independent Review Committee (IRC) assessment||participants|||Number
99310|NCT00819182|Other Pre-specified|Intervention Adherence|Number of breathing practice sessions per participant over the 16 week study period.|16 weeks|||Total practice sessions in 16 weeks||Standard Deviation|Mean
99311|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted at the week 16 post-randomization timepoint.|16 weeks|||Breaths Per Minute||Standard Deviation|Mean
99312|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group.|2 weeks|||Breaths Per Minute||Standard Deviation|Mean
99313|NCT00819182|Primary|Hot Flash Bother|Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
99314|NCT00819182|Primary|Hot Flash Severity|Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
99315|NCT00819182|Secondary|Sleep Disturbance|Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance.|16 weeks|||Global Sleep Disturbance Score||Standard Deviation|Mean
99316|NCT00819182|Secondary|Mood Disturbance|Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance.|16 weeks|||Scores on a scale||Standard Deviation|Mean
99317|NCT00819182|Secondary|Perceived Control Over Hot Flashes|Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
99318|NCT00819182|Secondary|Hot Flash Related Daily Interference|Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.|16 weeks|Analysis based on all randomized participants.||Scores on a scale||Standard Deviation|Mean
99319|NCT00819182|Primary|Hot Flash Frequency|Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.|16 weeks|Analysis based on all randomized participants.||Hot flashes per 24 hr||Standard Deviation|Mean
99320|NCT00819156|Secondary|The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population||participants|||Number
99321|NCT00819156|Secondary|The Number of Patients With Abnormal Liver Function Tests|The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.|364 days|ITT population||participants|||Number
99322|NCT00819156|Secondary|Median Values for Follicle Stimulation Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population||international units / liter||Full Range|Median
99323|NCT00819156|Secondary|Median Values for Serum Luteinizing Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population||international units / liter||Full Range|Median
99324|NCT00819156|Secondary|Median Values of Di-Hydrotestosterone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population||picogram / milliliter||Full Range|Median
99325|NCT00819156|Secondary|Median Prostate-specific Antigen Levels||Day 0 (Baseline), Days 3, 7, 14, and 364|ITT population||nanogram / milliliter||Full Range|Median
99326|NCT00819156|Secondary|Median Serum Testosterone Levels||Day 0 (Baseline), Days 1,3,7,14, and 364|ITT population||nanogram/milliliter||Full Range|Median
99327|NCT00819156|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.|Day 0 (post dose) to Day 364|Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.||days||Full Range|Median
99328|NCT00819156|Secondary|Days to 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population||days||Full Range|Median
99338|NCT00819910|Primary|Percent Change in Triglyceride (TG) Levels Post Treatment|The reported percent change is the difference between TG levels obtained on initial visit (day 0) and TG levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|Mean percent change post treatment ( unit %). TG was measured using mg/dL units||% change||Standard Deviation|Mean
99339|NCT00819832|Primary|Phase 2: Change in CTCB From Baseline to Post-treatment||CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)||||||
99340|NCT00819832|Primary|Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)|Increase in number of cancer cells in patient’s blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).|Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)|Study terminated by sponsor; No data analysis done on limited amount of data gathered.|||||
99341|NCT00819780|Secondary|Number of Participants With Adverse Events (AEs)|Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.|The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm.|Safety analysis set, which included all randomized participants who received at least 1 dose of protocol treatment (ie, panitumumab, bevacizumab, or any component of mFOLFOX6).||participants|||Number
99342|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS/BRAF Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.||percentage of participants||95% Confidence Interval|Number
99343|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS|"Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.~Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.||percentage of participants||95% Confidence Interval|Number
99344|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS / BRAF|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.||months||95% Confidence Interval|Median
99345|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.||months||95% Confidence Interval|Median
99346|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.||months||95% Confidence Interval|Median
99416|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants.|At Entry|Analysis is based on all off-ART participants with HIV-1 RNA data at entry.||log10 copies/mL||Inter-Quartile Range|Median
99347|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.||months||95% Confidence Interval|Median
99348|NCT00819780|Secondary|Resection Rate|The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set||percentage of participants||95% Confidence Interval|Number
99349|NCT00819780|Secondary|Time to Initial Objective Response|For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator’s review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders||months||Inter-Quartile Range|Median
99350|NCT00819780|Secondary|Time to Disease Progression|Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set||months||95% Confidence Interval|Median
99351|NCT00819780|Secondary|Duration of Response|For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders||months||95% Confidence Interval|Median
99352|NCT00819780|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set, defined as the subset of participants in the ITT Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.||percentage of participants||95% Confidence Interval|Number
99353|NCT00819780|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set||months||95% Confidence Interval|Median
99354|NCT00819780|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat (ITT) analysis set (all randomized participants)||months||95% Confidence Interval|Median
99355|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Week 8 (End of Active Treatment) to 24-hours After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. The SBP at rest vs peak HR was recorded at Week 8 (end of active treatment) and Week 8 + 2 days (48-hrs after last dose; 24-hrs after missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Week 8 (Last dose; end of active treatment) and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.||mmHg||Standard Error|Least Squares Mean
99369|NCT00819741|Secondary|Change in 7-point Plasma Glucose Profile|Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
99356|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8|The difference in resting vs. peak (85% of the maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 (end of active treatment); the change in SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.||mmHg||Standard Error|Least Squares Mean
99357|NCT00819767|Primary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug. The Exercise Evaluable Set (EES) included all patients included in the FAS for whom the treadmill test values for SBP at peak were available at baseline and after a missed dose.||mmHg||Standard Error|Least Squares Mean
99358|NCT00819741|Secondary|Haematology: Haemoglobin|Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
99359|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ASAT)|The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
99360|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ALAT)|The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
99361|NCT00819741|Secondary|ECG (ElectroCardioGram)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
99362|NCT00819741|Secondary|Physical Examinations|The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.||Subjects|||Number
99363|NCT00819741|Secondary|Change in Blood Pressure|Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment|Week 0, week 16|Safety analysis set was defined as all randomised and exposed subjects.||mmHg||Standard Deviation|Mean
99364|NCT00819741|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-16|Safety analysis set was defined as all randomised and exposed subjects.||episodes|||Number
99365|NCT00819741|Secondary|Change in 2-hour Postprandial Serum C-peptide|Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||ng/ml||Standard Error|Least Squares Mean
99366|NCT00819741|Secondary|Change in Fasting Serum C-peptide|Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||ng/ml||Standard Error|Least Squares Mean
99367|NCT00819741|Secondary|Change in 2-hour Postprandial Serum Insulin|Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||mU/L||Standard Error|Least Squares Mean
99368|NCT00819741|Secondary|Change in Fasting Serum Insulin|Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.||mU/L||Standard Error|Least Squares Mean
99370|NCT00819741|Secondary|Change in 2-hour Postprandial Plasma Glucose|Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
99371|NCT00819741|Secondary|Change in Fasting Plasma Glucose|Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
99372|NCT00819741|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.|week -2 (screening), week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
99373|NCT00819637|Secondary|Pharmacokinetics of Arformoterol in This Clinical Setting||5 hours||||||
99374|NCT00819637|Secondary|All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles||5 hours||||||
99375|NCT00819637|Secondary|Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments|2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.|5 hours||||||
99376|NCT00819637|Secondary|Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)|The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.|5 hours||||||
99377|NCT00819637|Secondary|The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)||5 hours||||||
99378|NCT00819637|Secondary|The Time to Onset of a 15% Improvement in FEV1 for Each Dose (Individual and Cumulative) and Total Dose of Study Medication to Reach This||5 hour||||||
99379|NCT00819637|Secondary|The Peak Change (Liters) and Peak Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour||||||
99380|NCT00819637|Secondary|The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour||||||
99381|NCT00819637|Secondary|The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour||||||
99382|NCT00819637|Primary|The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug||1 hour|As the study was terminated with 2 subjects enrolled, those 2 subjects were used for the limited statistical analysis.||percent change||95% Confidence Interval|Median
99383|NCT00819637|Secondary|Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.||5 hours||||||
99384|NCT00819637|Secondary|Most Effective Dose of Inhalation Arformoterol for Treating Acute Bronchospasm in Asthmatics by Evaluating the Averaged Mean Percent Change From Baseline % Predicted FEV1 After 3 Doses of Study Medication in Each of the 3 Groups||1 hour||||||
99385|NCT00819585|Secondary|Physician’s Global Assessment of Response to Therapy on a 5-point Likert Scale for Each Canakinumab Treatment Arm as Compared to Colchicine|To evaluate the efficacy of canakinumab as compared to colchicine with regards to the Physician’s global assessment of response to therapy on a 5-point Likert scale up to 16 weeks after randomization. The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, Good, Fair, Poor, Very poor. Physician’s global assessment was performed at the visits like Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), Day 85 (Visit 6), Day 113 (Visit 7), and Day 141 (Visit 8). The category ‘Not assessed’ combines the missing and 'not done'.|At Day 15, Day 29, Day 57, Day 85, Day 113 and Day 141|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Participants|||Number
99386|NCT00819585|Primary|The Mean Number of Gout Flares for Each Treatment Arm|The primary efficacy variable was number of gout flares per participant per arm. Mean number of gout flares per treatment arm was derived from this primary variable. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. The target dose was defined as the minimum single dose that leads to at least the same expected efficacy as the expected efficacy of the comparator colchicine with respect to the mean number of gout flares. Four dose-response models (linear, linear in log-dose, logistic and emax) were chosen.|16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||gout flares||Standard Deviation|Mean
99387|NCT00819585|Secondary|Patient's Global Pain Intensity on 5-point Likert Scale up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine|"Participants were handed out a diary at baseline (Visit 2), Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), Day 85 (Visit 6), Day 113 (Visit 7), and Day 141 (Visit 8) to record information on a daily basis during a gout flare. The patients were to score their current amount of acute gout pain in the joint on a 5-point Likert scale 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme.~on the day of onset of the gout flare and~in the morning of the 6 following days"|up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Units on a scale||Standard Deviation|Mean
99406|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 24|Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
99407|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 12|Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
99388|NCT00819585|Secondary|Patient’s Global Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) up to Day 7 During All Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine|"The pain intensity on a 0-100 mm VAS scale, ranging from no pain (0) to unbearable pain (100) in the affected joint (Scores on the 100-mm linear scale were measured to the nearest millimeter from the left)~on the day of onset of the gout flare and~in the morning of the 6 following days"|up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Units on a scale||Standard Deviation|Mean
99389|NCT00819585|Secondary|The Percentage of Participants With Gout Flare at Different Time Points for Each Canakinumab Treatment Arm as Compared to Colchicine|A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. The start of a gout flare was defined as that day when the patient reported increased pain in the most affected joint for the first time in the patient diary. The end of a gout flare was defined as the patient’s confirmation in the diary that the patient felt he/she had recovered from the gout flare or the acute gout pain had disappeared (whichever was first).|2 days, 4 days, 6 days, 2 weeks, 4 weeks, 6 weeks, 10 weeks and 16 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of participants||95% Confidence Interval|Number
99390|NCT00819585|Secondary|The Percentage of Participants With Gout Flares for Each Canakinumab Treatment Arm as Compared to Colchicine|The percentage of participants experiencing at least one gout flare within 16 weeks after randomization. A gout flare was defined as an increase in patient-reported gout pain in the most affected joint during a gout attack. The start of a gout flare was defined as that day when the patient reported increased pain in the most affected joint for the first time in the patient diary. The end of a gout flare was defined as the patient’s confirmation in the diary that the patient felt he/she had recovered from the gout flare or the acute gout pain had disappeared (whichever was first).|16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Percentage of participants|||Number
99391|NCT00819585|Secondary|The Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab||up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||gout flares per patient||Standard Error|Least Squares Mean
99392|NCT00819403|Secondary|Biomarkers of Inflammation||6 weeks|||mg/dl||Standard Deviation|Mean
99393|NCT00819403|Primary|Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression|Measured using whole blood flow cytometry|6 weeks|Based on power calculations||ng/dl||Standard Deviation|Mean
99394|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24|Results reported are the week 24 percent activation levels of pDC and mDC.|At week 24|Analysis is based on all participants with assay data at week 24.||percentage of cells||Inter-Quartile Range|Median
99395|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12|Results reported are the week 12 percent activation levels of pDC and mDC.|At week 12|Analysis is based on all participants with assay data at week 12.||percentage of cells||Inter-Quartile Range|Median
99396|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline|Baseline percent activation levels of pDC were computed as the mean of pre-entry and entry percent activation levels of pDC. Similarly, baseline percent activation levels of mDC were computed as the mean of pre-entry and entry percent activation levels of mDC.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||percentage of cells||Inter-Quartile Range|Median
99397|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 24|Results reported are the week 24 fasting LPS.|At week 24|Analysis is based on all participants with assay data at week 24.||pg/mL||Inter-Quartile Range|Median
99398|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 12|Results reported are the week 12 fasting LPS.|At week 12|Analysis is based on all participants with assay data at week 12.||pg/mL||Inter-Quartile Range|Median
99399|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Entry|Results reported are for entry fasting LPS.|At entry|Analysis is based on all participants with assay data at entry.||pg/mL||Inter-Quartile Range|Median
99400|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 24|Results reported are the week 24 sCD14.|At week 24|Analysis is based on all participants with assay data at week 24.||million pg/mL||Inter-Quartile Range|Median
99401|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 12|Results reported are the week 12 sCD14.|At week 12|Analysis is based on all participants with assay data at week 12.||million pg/mL||Inter-Quartile Range|Median
99402|NCT00819390|Secondary|Soluble CD14 (sCD14) at Baseline|Baseline sCD14 was computed as the mean of pre-entry and entry sCD14.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||million pg/mL||Inter-Quartile Range|Median
99403|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24|Results reported are the week 24 IL-6, sTNF-rI and D-dimer.|At week 24|Analysis is based on all participants with assay data at week 24.||pg/mL||Inter-Quartile Range|Median
99404|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12|Results reported are the week 12 IL-6, sTNF-rI and D-dimer.|At week 12|Analysis is based on all participants with assay data at week 12.||pg/mL||Inter-Quartile Range|Median
99405|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline|Baseline IL-6, sTNF-rI and D-dimer were computed as the mean of pre-entry and entry IL-6, sTNF-rI and D-dimer, respectively.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.||pg/mL||Inter-Quartile Range|Median
99417|NCT00819390|Secondary|Number of Participants With Events Grade 3 or Higher|Events included signs and symptoms, laboratory abnormalities and/or clinical events grade 3 or higher which were described by site clinician blinded to the treatment arm as definitely or possibly related to the study treatment.|From start of study treatment to study completion at week 28|Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment.||participants|||Number
99418|NCT00819390|Secondary|Change in Total CD4 T Cell Count From Baseline to Week 12|Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||cells/mm^3||Inter-Quartile Range|Median
99419|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|At Pre-entry, entry, Weeks 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
99420|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24|The mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ is subtracted from the mean of the week 22 and week 24 percent CD8 HLA-DR+/CD38+|At Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at weeks 10 or 12, and 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
99421|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period|For Arm A: Chloroquine then Placebo for off-ART participants and Arm C: Chloroquine then Placebo for on-ART participants, the baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+. For Arm B: Placebo then Chloroquine for off-ART participants and Arm D: Placebo then Chloroquine for on-ART participants, the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at the required time points, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
99422|NCT00819390|Primary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+.|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
99423|NCT00819286|Primary|Activity Based Total Visual Analog Pain Score|"Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an Activity Based Total Visual Analog Pain Score, (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated."|6 months|All patients with VAS pain data at 6 months were included in the analysis of the primary endpoint Activity Based Total Visual Analog Pain Score.||units on a scale||Standard Deviation|Mean
99424|NCT00819286|Primary|CT Scan Evaluation of Sternal Bone Healing|Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)|3 and 6 Months|Patients were randomized to receive a CT scan at either 3 or 6 months. All patients who received a CT scan were included in the analysis.||units on a scale||Standard Deviation|Mean
99425|NCT00819260|Secondary|Hematoma|A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.|first day after surgery|entire study population||participants|||Number
99426|NCT00819260|Secondary|Pain Level in Surgical Sites|An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.|first week after surgery|all study participants||units on a scale||Standard Deviation|Median
99427|NCT00819260|Secondary|Volume of Drainage in Surgical Drains|An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.|within one week of surgery|All participants in the study.||mL/hour||Standard Deviation|Median
99428|NCT00819260|Primary|Time for Operation|Time to complete the breast reduction per breast.|day of surgery|Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.||minutes||Standard Deviation|Median
99429|NCT00819247|Secondary|Percentage Change in Vital Signs and Body Weight|Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.|Baseline and Six months|Safety population.||percentage||Full Range|Median
99430|NCT00819247|Secondary|The Number of Participants With Abnormal Liver Function Tests|The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.|Six months|Randomized (Safety) population||participants|||Number
99431|NCT00819247|Secondary|Number of Participants With Normal Prostate-specific Antigen Levels During the Study|The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).|Weeks 12, 24|Per Protocol Population||participants|||Number
99432|NCT00819247|Secondary|Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen|Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.|Six months|per protocol population||participants|||Number
99433|NCT00819247|Secondary|Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24|Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.|Weeks 4-24|Per protocol population||participants|||Number
99434|NCT00819247|Secondary|Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24||Weeks 4-24|Per protocol population||participants|||Number
99435|NCT00819247|Primary|Number of Participants With Testosterone <0.5 Nanogram/Milliliter||Weeks 1,2,4,8,12,16,20,24|Per protocol population||participants|||Number
99436|NCT00819234|Secondary|Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to end of treatment follow up|N for Week 52 presented above. For Follow up: N=18,58,68,11,7,8.||participants|||Number
99437|NCT00819234|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population|Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a|Baseline to Week 52|All Enrolled participants who received at least one injection of any study medication in Study DFA102E; had laboratory data available. Number analyzed presented above is at Week 52; Number analyzed at Week 28: N= 31, 35, 36, 28, 13, 14, 13, 29, 37, 37.||Number of Laboratory values|||Number
99438|NCT00819234|Secondary|Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population|Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urinalysis: Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; participants had laboratory data available; platelet counts: n=19 in second arm (not 20); n=20 in fourth arm (not 22); n=11 in fifth arm (not 12);||number of laboratory values|||Number
99439|NCT00819234|Secondary|Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 52|Enrolled and received at least 1 injection of any treatment; had ECG data available at Week 52.||msec||Standard Deviation|Mean
99440|NCT00819234|Secondary|Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.||bpm||Standard Deviation|Mean
99441|NCT00819234|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).|Baseline (Day 1) to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.||mm Hg||Standard Deviation|Mean
99468|NCT00819052|Secondary|Time to Loss of Virologic Response|Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.|48 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||days||95% Confidence Interval|Median
99469|NCT00819052|Secondary|New AIDS or AIDS-related Progression Event or Death||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
99442|NCT00819234|Secondary|Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.|Baseline to end of treatment follow up|number (n) of participants who are Week 52 evaluable in a stable treatment sequence (received the same treatment in both DFA102 and DFA102E) and who had follow up data. Week 52 in Metreleptin 2.5 mg arm n=55 (all others n=56); Week 40 in Metreleptin 5 mg arm n=66 (all others n=68)||ng/mL||Standard Error|Geometric Mean
99443|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score – Week 52 Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
99444|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores – Week 52 Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
99445|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
99446|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores – Week 52 Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||units on a scale||Standard Deviation|Mean
99447|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population|Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Week 28) to Week 52|Participants analyzed had non-missing data at Week 52. Week 52 Evaluable Population: ITT participants (received at least 1 injection); remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock); no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.||participants|||Number
99470|NCT00819052|Secondary|Occurence of Hepatic Events||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
99471|NCT00819052|Secondary|Occurence of Rashes|drug-related rashes by severity|144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
103170|NCT00789724|Secondary|Difference Between the 2 Arms in Change in E/E' Ratios and Myocardial Performance (Tei) Indices From Baseline to Follow up Exam at Transthoracic Echo-color-Doppler Cardiac Exam||10-14 weeks||||||
99448|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population|Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Day 1) to Week 52|Number analyzed with non-missing data at Week 52. Week 52 Evaluable Population: All ITT participants (received at least 1 injection);remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock);no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.||participants|||Number
99449|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population|Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data in each treatment group. ITT population (received at least 1 injection) with treatment regimens same in DFA102/DFA102E (stable treatment); completed Week 52; no major protocol deviations in DFA102/102E.||µIU/mL||95% Confidence Interval|Least Squares Mean
99450|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population|Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline (Day 1) to Week 52|n=number of participants with non-missing data in each treatment group by test. glucose n=20,20,27,19; total cholesterol n=21,20,27,19; triglycerides n=21,20,27,19; LDL/HDL n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E (stable); completed Week 52; no major protocol deviations in DFA102 or DFA102E.||mg/dL||95% Confidence Interval|Least Squares Mean
99451|NCT00819234|Secondary|LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population|Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,27,19; Week 36 n=21,20,27,19; Week 44 n=21,20,27,19; Week 52 n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.||Percentage of change in weight||95% Confidence Interval|Least Squares Mean
99452|NCT00819234|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population|Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|Baseline to Week 52|n=number of participants with non-missing waist circumference data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,26,19; Week 36 n=21,20,27,19; Week 44 n=20,20,27,19; Week 52 n=21,19,27,19.ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.||cm||95% Confidence Interval|Least Squares Mean
99453|NCT00819234|Secondary|Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population|Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.|Original Study Baseline to Extension Week 52 and follow up|Enrolled and received at least 1 injection of metreleptin; treatment regimens same in both DFA102/DFA102E (stable population); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.||ng/mL||Standard Error|Geometric Mean
99472|NCT00819052|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of investigations related to treatment|until week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.||participants|||Number
99473|NCT00819052|Secondary|Change From Baseline in VL (HIV-1 Viral Load) at Each Visit||week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment, Observed Cases.||copies/mL||Standard Deviation|Mean
103171|NCT00789724|Secondary|Difference Between the 2 Arms in Change in End-diastolic Volume Indices and Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks||||||
99454|NCT00819234|Secondary|LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).|Original baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||kg||95% Confidence Interval|Least Squares Mean
99455|NCT00819234|Primary|LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.|Original Study Baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.||percentage of change in weight||95% Confidence Interval|Least Squares Mean
99456|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
99457|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 6|Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 6|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
99458|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).||percent||Standard Error|Least Squares Mean
99459|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 12|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).||percent||Standard Error|Least Squares Mean
99460|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6|HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 6|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).||percent||Standard Error|Least Squares Mean
99461|NCT00819091|Secondary|Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18|An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.|Baseline, week 18|FAS patients. Non-completers were considered as failure imputation (NCF).||percentage of participants|||Number
99462|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18|An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of participants|||Number
99463|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18|An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||Percentage of Patients|||Number
99464|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 18|Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
99465|NCT00819091|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Least Squares Mean
99466|NCT00819052|Secondary|Trough Plasma Concentration|Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).|Day 1 to week 48|All patients with evaluable PK data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
99467|NCT00819052|Secondary|Genotypic Resistance Associated With Virologic Failure|"Genotypic resistance associated with virologic failure.~This endpoint was not analysed due to lack of data."|48 weeks|All patients in the treated set who experienced virologic failure.|||||
99474|NCT00819052|Secondary|Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 144.||participants|||Number
99475|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population||baseline, last available visit (up to 144 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and last visit (up to 144 weeks).||cells/cubic millimeter||Standard Deviation|Mean
99476|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 144.||cells/cubic millimeter||Standard Deviation|Mean
99477|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population||baseline, week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 132.||cells/cubic millimeter||Standard Deviation|Mean
99478|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population||baseline, week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 120.||cells/cubic millimeter||Standard Deviation|Mean
99479|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population||baseline, week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 108.||cells/cubic millimeter||Standard Deviation|Mean
99480|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population||baseline, week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 96.||cells/cubic millimeter||Standard Deviation|Mean
99481|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population||baseline, week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 84.||cells/cubic millimeter||Standard Deviation|Mean
99482|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population||baseline, week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 72.||cells/cubic millimeter||Standard Deviation|Mean
99483|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population||baseline, week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 60.||cells/cubic millimeter||Standard Deviation|Mean
99484|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population||baseline, week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 48.||cells/cubic millimeter||Standard Deviation|Mean
99485|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response at their last available visit|last available visit, up to 144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at last visit (up to 144 weeks).||participants|||Number
99486|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 144.||participants|||Number
99487|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 132|week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 132.||participants|||Number
99488|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 120|week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 120.||participants|||Number
99489|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 108|week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 108.||participants|||Number
103172|NCT00789724|Primary|Difference Between the Anakinra Arm and Placebo Arm in Change in End-systolic Volume Indices From Baseline to Follow up Exam 10-14 Weeks Later at Cardiac Magnetic Resonance Imaging.||10-14 weeks|||mL/m2||Inter-Quartile Range|Median
99490|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 96|week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 96.||participants|||Number
99491|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 84|week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 84.||participants|||Number
99492|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 72|week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 72.||participants|||Number
99493|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 60|week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 60.||participants|||Number
99494|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 48|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 48.||participants|||Number
99495|NCT00819052|Secondary|Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.The population was restricted to participants who had CD4 count at baseline and week 24.||cells/cubic millimeter||Standard Error|Least Squares Mean
99496|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 24.||cells/cubic millimeter||Standard Deviation|Mean
99497|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population||baseline, week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 12.||cells/cubic millimeter||Standard Deviation|Mean
99498|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population||baseline, week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 8.||cells/cubic millimeter||Standard Deviation|Mean
99499|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population||baseline, week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4.||cells/cubic millimeter||Standard Deviation|Mean
99500|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population||baseline, week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2.||cells/cubic millimeter||Standard Deviation|Mean
99501|NCT00819052|Secondary|Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population||week 0|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline.||cells/cubic millimeter||Standard Deviation|Mean
99502|NCT00819052|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||proportion of participants|||Number
99503|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
99504|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 12|week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
99505|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 8|week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
99506|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 4|week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
99507|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 2|week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
99508|NCT00819052|Primary|Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment||participants|||Number
99509|NCT00819039|Secondary|Number of Participants With Vomiting Frequency in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
99510|NCT00819039|Secondary|Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.|Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
99511|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2||Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
99512|NCT00819039|Secondary|Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.|Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
99513|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.||Participants|||Number
99514|NCT00819039|Primary|Number of Participants Discontinuing Study Treatment Due to AEs||Day 1|The population consists of all participants that received at least one dose of study medication.||Participants|||Number
99515|NCT00819039|Primary|Number of Participants Experiencing Adverse Events (AEs)||Up to 21 Days Post-Surgery|The population consists of all participants that received at least one dose of study medication.||Participants|||Number
99516|NCT00819039|Primary|Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1|The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C48 hr data were available.||ng/mL||Standard Deviation|Mean
99517|NCT00819039|Primary|Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that >50% of measurements were below the lower level of quantitaion (LLOQ).|24 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C24 hr data were available.||ng/mL||Standard Deviation|Mean
99518|NCT00819039|Primary|Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Tmax data were available.||Hours||Full Range|Median
99519|NCT00819039|Primary|Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Cmax data were available.||ng/mL||Standard Deviation|Mean
99520|NCT00819039|Primary|Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.|Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose|The population consisted of all participants that received at least one dose of study medication and for which AUC0-48 data were available.||hr*ug/ml||Standard Deviation|Mean
99521|NCT00819013|Secondary|Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.~Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods"|Day 0 and Day 15 through Month 10 Post-vaccination 1|Seropositivity to Hepatitis B core antigen was assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||Participants|||Number
99522|NCT00819013|Secondary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 15 through Month 10 post-vaccination 1|Antibody responses were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.||1/diultion (1/dil)||95% Confidence Interval|Geometric Mean
99536|NCT00818961|Secondary|Platelet Engraftment|The number of patients experiencing platelet engraftment post-transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of platelet engraftment.||participants|||Number
99523|NCT00819013|Secondary|Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
99524|NCT00819013|Secondary|Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).~A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)."|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
99525|NCT00819013|Secondary|Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 60 Post-vaccination 1|Seroconversion to M2e antigens were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.||Participants|||Number
99526|NCT00819013|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.|"Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).~A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)"|Day 15 through Month 10 Post-vaccination 1|Geometric mean titers of the respective vaccine antibodies were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population; per-protocol population.||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
99527|NCT00819013|Primary|Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine|Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 15 through Month 10 Post-vaccination 1|Seroconversion to M2e antigen was assessed participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population.||Participants|||Number
99528|NCT00819013|Secondary|Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.|Month 4 through Month 10 post-vaccination 1|Influenza signs and symptoms were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.||Participants|||Number
99529|NCT00819013|Primary|Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.||Day 0 through Day 60 post-vaccination 1|Laboratory parameters were assessed in participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations (Intent-to-treat Population).||Participants|||Number
99530|NCT00819013|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.|Day 0 through Day 7 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.||Participants|||Number
99531|NCT00819013|Primary|Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.||Day 0 through Day 60 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.||Participants|||Number
99532|NCT00818961|Secondary|Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant|Patients will be evaluated up to 4 years post transplant|4 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of VOD post-transplant||participants|||Number
99533|NCT00818961|Secondary|Number of Patients Experiencing Chronic Graft Versus Host Disease||>100 days post-transplant|35 patients survive past 100 days post-transplant and therefore were eligible for evaluation of chronic graft versus host disease||participants|||Number
99534|NCT00818961|Secondary|Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant|patients experiencing acute graft versus host disease post-transplant|patients were followed for 2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of acute graft versus host disease post-transplant.||participants|||Number
99535|NCT00818961|Secondary|Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism|DLI is used for patients with mixed chimerism following transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for donor leukocyte infusions for mixed chimerism following transplant||participants|||Number
99538|NCT00818961|Secondary|Complete Donor Chimerism|Complete donor chimerism (defined as >/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured.|2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of donor chimerism||participants|||Number
99539|NCT00818961|Secondary|Non-relapse Mortality at 1 Year Post-transplant|Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive.|1 year|36 patients underwent hematopoietic stem cell transplant. 10 patients died prior to 1 year post-transplant and were eligible for evaluation of non-relapse mortality at 1 year post-transplant||participants|||Number
99540|NCT00818961|Secondary|Non-relapse Mortality at Day 100|patients are evaluable for their cause of death at Day 100|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of non-relapse mortality at Day 100||participants|||Number
99541|NCT00818961|Secondary|Overall Survival at 1 Year|Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant)|1 year|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at one year post-transplant||participants|||Number
99542|NCT00818961|Primary|Survival at Day 100|Survival at Day 100|100 day|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at 100 days||participants|||Number
99543|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at each week indicated, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease or <130/80 mm Hg for participants with diabetes or chronic kidney disease[GFR <60 mL/min/1.73 m2 or urinary albumin:creatinine ratio (UACR) >200 mg albumin/g creatinine at Screening.] Systolic/diastolic blood pressure is the average of the 3 serial trough sitting systolic/diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||percentage of participants|||Number
99544|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as <90 mm Hg for participants without diabetes or chronic kidney disease or <80 mm Hg for participants with diabetes or chronic kidney disease. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||percentage of participants|||Number
99545|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as <140mm Hg without diabetes or chronic kidney disease or <130/mm Hg with diabetes or chronic kidney disease. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||percentage of participants|||Number
99546|NCT00818883|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99547|NCT00818883|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99548|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99604|NCT00818623|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.|3 months|ITT population||days||Full Range|Median
99549|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99550|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99551|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99552|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99553|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99554|NCT00818883|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99555|NCT00818883|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99556|NCT00818883|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99557|NCT00818883|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure|The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
99558|NCT00818805|Secondary|Change in Total Score in Ocular Symptom Questionnaire||15-180 min.||||||
99559|NCT00818805|Primary|Change in “Ocular Itching” Score (5-point Scale) in Subjective Symptom Questionnaire|Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.|0-180 minutes after entering the examination room|||Units on a scale||Standard Deviation|Mean
99560|NCT00818779|Secondary|Serum Level of Nitric Oxide||6 week||||||
99564|NCT00818779|Primary|Plasminogen Activator Inhibitor 1|Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.|6 weeks|||ng/ml||95% Confidence Interval|Mean
99565|NCT00818753|Secondary|Number of Participants With Bleeding Events|Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first).|First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)|Treated set. All randomised patients who were documented to have taken at least 1 dose of study drug.||participants|||Number
99566|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
99567|NCT00818753|Secondary|Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
99568|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
99569|NCT00818753|Primary|Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention||Percentage of participants|||Number
99570|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Rash|Participants requiring systemic therapy or discontinuation from further treatment|Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
99571|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits||Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
99572|NCT00818662|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)||Throughout each infusion period|Safety Analysis Set||Adverse events|Participants||Number
99573|NCT00818662|Secondary|Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered|Throughout the study period, approximately 4 years|Safety Analysis Set||Infusions|Participants||Number
99574|NCT00818662|Secondary|Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)|During or within 72 hours of completion of an infusion|Safety Analysis Set||Infusions|Participants||Number
99575|NCT00818662|Secondary|Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class|Related and unrelated SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
99576|NCT00818662|Secondary|Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class|Related and unrelated non-SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
99577|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
99578|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set||participants|||Number
99579|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test|In this test, which assesses constructional ability, visuoperception, and executive functioning, the participant is given a blank sheet of paper and asked to draw the face of a clock showing the numbers and 2 hands set to ‘ten after eleven.’ Results are presented as score obtained (range 0 to 5, with 0 indicating the greatest impairment).|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
99580|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||seconds||Standard Deviation|Mean
99590|NCT00818662|Secondary|Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination|The 3MS is a comprehensive validated instrument that provides a 100 point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. Scores range from 0 to 100 with lower values indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
99605|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.|3 months|ITT population.||participants|||Number
99581|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part A range between 0 and 150 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||seconds||Standard Deviation|Mean
99582|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency|In this test, which assesses semantic verbal fluency, participants are given 1 minute to name as many items in the category “animals” as possible. To receive credit that word cannot be a mythical animal, but can be an animal species; breed; male, female, or infant name for a species (e.g., bull, cow, calf); in addition, names for birds, fish, reptiles, and insects receive credit. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
99583|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution|WAIS–R digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a ‘key,’ which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
99584|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency|In the FAS assessment of phenomic verbal fluency, participants are given 1 minute each to name as many words as they can that begin with a specified letter (F, A, S). To receive credit, words must be verifiable in a dictionary, cannot be proper nouns, and cannot be the same word or variations of the same word (e.g., the same word with a different ending, such as ‘acts,’ ‘acted,’ ‘acting’). Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
99585|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
99586|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.||correct responses||Standard Deviation|Mean
99587|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
99588|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant’s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
99589|NCT00818662|Secondary|Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
99603|NCT00818623|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.||days||Full Range|Median
99591|NCT00818662|Secondary|Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.~A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).~Very much better~Much better~A little better~Same~A little worse~Much worse~Very much worse"|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||participants|||Number
99592|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant’s clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.~A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).~Very much better~Much better~A little better~Same~A little worse~Much worse~Very much worse"|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.||participants|||Number
99593|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.||Scores on a scale||Standard Deviation|Mean
99594|NCT00818662|Secondary|Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 9 months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.||Scores on a scale||Standard Deviation|Mean
99595|NCT00818662|Primary|Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
99596|NCT00818662|Primary|Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.||Scores on a scale||Standard Deviation|Mean
99597|NCT00818649|Secondary|Correlation of the Above Changes With Response||Pre-Study and After 3 Cycles||||||
99598|NCT00818649|Secondary|Analysis of Natural Killer (NK) Cell Activating and Inhibitory Receptor Alterations, NK Cell Receptor Ligand Alterations, HLA Class I Expression on Target Cells (Myeloid Blasts), and NK-mediated Cell Killing||Pre-Study and After 3 Cycles||||||
99599|NCT00818649|Primary|Number of Patients by Best Clinical Response|Assessed by the International Working Group response criteria: Categories include Complete Remission (CR), Partial Remission (PR), Marrow CR, Hematologic Improvement (HI), Stable Disease, Cytogenic Response and Disease Progression. clinical response = CR+PR+HI. Thus, all patients who complete at least 1 full cycle of therapy will be considered evaluable for response.|At Completion of Course 3 (Day 63)|Evaluable patients are defined as those who completed at least 1 cycle of therapy; 8 had acute myeloid leukemia, 4 had myelodysplastic syndrome.||Patients|||Number
99600|NCT00818623|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.||participants|||Number
99601|NCT00818623|Secondary|Evaluation of Liver Function Tests|The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months|||participants|||Number
99602|NCT00818623|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.||days||Full Range|Median
99606|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.|Two - six months|ITT population.||participants|||Number
99607|NCT00818623|Primary|Time From Dosing Until Testosterone Levels >0.5 ng/mL|Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.|3 months|ITT population.||days||95% Confidence Interval|Median
99608|NCT00818519|Secondary|Percentage of Participants Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Rating|"The proportion of participants rated as “improved” comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator’s Overall Improvement Rating and those with excellent, good, or fair improvement the Participant’s Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise not improved status."|At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)|FAS (due to missing data number of participants differs from number at Baseline)||Percentage of participants|||Number
99609|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones|Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
99610|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones|Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
99611|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules|Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
99612|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules|Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
99613|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Papules|Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
99614|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)||Percent change||Standard Deviation|Mean
99615|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 6 (Day 15±3 days of Treatment Cycle 6)|FAS, all participants with data for Cycle 6||Percentage of participants|||Number
99616|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 3 (Day 15±3 days of Treatment Cycle 3)|FAS, all participants with data for Cycle 3||Percentage of participants|||Number
99629|NCT00818454|Primary|Peak FEV1 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||liters||Standard Error|Least Squares Mean
99617|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 1 (Day 15±3 days of Treatment Cycle 1)|FAS, all participants with data for Cycle 1||Percentage of participants|||Number
99618|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Screening visit|Full analysis set at screening||Percentage of participants|||Number
99619|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|PPS||Percent change||Standard Deviation|Mean
99620|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS||Percent change||Standard Deviation|Mean
99621|NCT00818454|Secondary|Peak FEV1 Response|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.||liters||Standard Error|Least Squares Mean
99622|NCT00818454|Secondary|FEV1 AUC0-6 Response (Parallel Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under the Curve from 0 to 6 hours|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.||liters||Standard Error|Least Squares Mean
99623|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
99624|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
99625|NCT00818454|Secondary|Puffs Study Medication Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
99626|NCT00818454|Secondary|Puffs Study Medication Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Puffs||Standard Error|Least Squares Mean
99627|NCT00818454|Secondary|Asthma Control Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in ACQ score. Worst score - 6(most severe), best score - 0 (no symptoms)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Scores on scale||Standard Error|Least Squares Mean
99628|NCT00818454|Secondary|Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in Mini-AQLQ score. Worst score - 1 (most severe), best score - 7 (less severe)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||Scores on scale||Standard Error|Least Squares Mean
99630|NCT00818454|Primary|FEV1 AUC0-6 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.||liters||Standard Error|Least Squares Mean
99631|NCT00818441|Secondary|Trough Plasma Concentrations (Ctrough) of Dacomitinib|Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).|Predose on C1D14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis set: all participants who received at least 1 dose of study medication at selected PK sites from whom at least 1 PK sample were obtained. 'N' (number of participants analyzed) = participants who were evaluable for this measure at any time point. n = participants evaluable at given time points for specified dose.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
99632|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of <10.|Baseline (C1D1) up to C75|PRO analysis set: participants who received >=1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. n=participants evaluable at specified time points for given parameter.||number of participants|||Number
99633|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of <10.|Baseline (Cycle [C]1 Day 1), up to C75|Patient reported Outcome (PRO) analysis set:participants who received at least (>=) 1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. 'N' (number of participants analyzed)=participants evaluable for this measure.n=participants evaluable at specified time points for given parameter.||number of participants|||Number
99634|NCT00818441|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Randomization until death or last date known to be alive.|As-enrolled population included all participants who were enrolled in the study.||months||95% Confidence Interval|Median
99635|NCT00818441|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|DR was calculated for a subgroup of participants from the response-evaluable population, who had confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
99636|NCT00818441|Secondary|Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|Response-evaluable population included all enrolled participants who received at least 1 dose of study medication, had an adequate baseline tumor assessment, and had at least 1 on-study tumor assessment after the first dosing.||participants|||Number
99754|NCT00816036|Primary|7-day Point-prevalence Smoking Abstinence (6-month)|This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.|6 months post enrollment|This is the total number of subjects who completed 6 month follow-up (complete case analysis).||participants|||Number
99637|NCT00818441|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|As-enrolled population included all participants who were enrolled in the study.||months||95% Confidence Interval|Median
99638|NCT00818441|Secondary|Progression-Free Survival (PFS) at Month 4: Cohort B|PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on RECIST v1.0 criteria. PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4|||percent chance of being event-free||95% Confidence Interval|Number
99639|NCT00818441|Primary|Progression-Free Survival (PFS) at Month 4: Cohort A|PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4|As-enrolled population included all participants who were enrolled in the study.||percentage of participants||95% Confidence Interval|Number
99640|NCT00818389|Secondary|Vital Capacity (VC) (Percent of Predicted Normal)|Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group.|9 months: Baseline to study termination (January 2009- October 2009)|||Percent of predicted normal||Standard Error|Mean
99641|NCT00818389|Primary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.|9 months: Baseline to study termination (January 2009 - October 2009)|||Participants|||Number
99642|NCT00818389|Secondary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group.|9 months: Baseline to study termination (January 2009 - October 2009)|||Scores on a scale||Standard Error|Mean
99643|NCT00818337|Secondary|Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg|Aspirin resistance was defined as ARU > 550|2 weeks|||participants|||Number
99644|NCT00818337|Primary|Number of Women Aspirin Resistant|Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.|Baseline|||participants|||Number
99645|NCT00818324|Other Pre-specified|Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52|||LGCS score||Standard Deviation|Mean
99646|NCT00818324|Primary|Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52|||FCS score||Standard Deviation|Mean
99647|NCT00818272|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screeing test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~Missing"|Baseline|||Participants|||Number
99648|NCT00818272|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|||Participants|||Number
99688|NCT00817778|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment|||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
99649|NCT00818272|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|||Participants|||Number
99650|NCT00818272|Secondary|Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion|The CDAI score is used to quantify the symptoms of participants with CD. The CDAI incorporates 8 items added together that are indicators of disease severity. Scores range from 0 to 600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. A decrease in CDAI over time indicates improvement in disease activity. CDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first Infusion|Data was analyzed for all CD participants whose data had been entered in the database and finalized by signature of the physician. 90 out of 148 participants available at enrollment completed the CDAI and 42 out of the 128 available participants at first infusion after screening (beginning of 2 year observation period) completed the CDAI.||Score on a scale||Standard Deviation|Mean
99651|NCT00818272|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician’s awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|||Participants|||Number
99652|NCT00818259|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.|Day 1 up to Day 3|The ASaT population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
99653|NCT00818259|Secondary|Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age|Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post dexamethasone dose|This population was to consist of all participants from birth to 1 year of age who received at least one dose of dexamethasone and were evaluable for this PK parameter. These analyses were not conducted; enrollment of this cohort was not opened as enrollment of participants from birth to <6 months of age into Part II was unsuccessful.|||||
99654|NCT00818259|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.|Up to 14 days after last dose of study drug (Up to 17 days)|The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
99655|NCT00818259|Primary|Tmax for Fosaprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.||hr||Standard Deviation|Mean
99656|NCT00818259|Primary|Cmax for Fosaprepitant|Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.||ng/mL||Standard Deviation|Mean
99657|NCT00818259|Primary|Apparent Terminal Half-life (t1/2) for Aprepitant|t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||hr||Standard Deviation|Mean
99708|NCT00817219|Secondary|“Controlled Disease”(i.e., “Clear” or “Almost Clear”) According to the Investigator’s Global Assessment of Disease Severity at Week 4.|The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.|Week 4|||participants|||Number
99658|NCT00818259|Primary|Time to Cmax (Tmax) for Aprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||hr||Standard Deviation|Mean
99659|NCT00818259|Primary|Maximum Plasma Concentration (Cmax) for Aprepitant|Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||ng/mL||Standard Deviation|Mean
99660|NCT00818259|Primary|Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant|AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.||hr*ng/mL||Standard Deviation|Mean
99661|NCT00818246|Secondary|Number of Adverse Events.|Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.|Adverse reactions were monitored throughout the study and up to 4 weeks.|Intention to treat (ITT)||Number of adverse events|||Number
99662|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Rz values (peak to valley analysis) to quantify rhytid depth and severity.|Baseline and 4 weeks|Per Protocol||Percent change post-treatment||95% Confidence Interval|Mean
99663|NCT00818246|Secondary|Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.|Clinical qualitative assessment was performed by three blinded medical observers through the evaluation of digital photographs. The photographs were analyzed for clinical improvement using the Fitzpatrick Classification System (FCS)subtype scale for degree of wrinkling (rhytids). Their assessment was rated on a five-point scale and scored as follows; 0=none; 1=mild; 2=moderate; 3=good; 4=excellent.|Baseline and 4 weeks|Per Protocol||Change in units on the FCS scale||95% Confidence Interval|Mean
99664|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Ra values (skin surface roughness).|Baseline and 4 weeks|Per Protocol||Percent change post-treatment||95% Confidence Interval|Mean
99665|NCT00818207|Secondary|Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52|"LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days? and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52"|Week 26 to Week 52|ITT||Percentage of Participants|||Number
99666|NCT00818207|Secondary|Percentage of Participants With 7-Day PP of Abstinence at Week 13|"PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?"|Week 13|ITT||Percentage of Participants|||Number
99667|NCT00818207|Secondary|Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52|"CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions Have you smoked any cigarettes (even a puff) since the last contact/visit? at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit? and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing."|Week 26, Week 39, and Week 52|ITT||Percentage of Participants|||Number
99668|NCT00818207|Secondary|Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco|"PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days? confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL])."|Week 26|ITT||Percentage of Participants|||Number
99669|NCT00818207|Primary|Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence|"Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?"|Week 26|Intent to Treat (ITT) Population: all randomized participants||Percentage of Participants|||Number
99670|NCT00818168|Secondary|Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion|The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first infusion|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Units on a scale||Standard Deviation|Mean
99671|NCT00818168|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~Missing"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Participants|||Number
99672|NCT00818168|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Participants|||Number
99673|NCT00818168|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||Participants|||Number
99674|NCT00818168|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.||participants|||Number
99675|NCT00818116|Primary|Uncorrected and Best Corrected Visual Acuities (Near and Distance)|Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 Months Following Cataract Surgery|||logMAR||Standard Deviation|Mean
99676|NCT00817999|Primary|% Platelet Inhibition|% platelet inhibition measured by Verify Now|6 hours|||percentage of platelet inhibition||Standard Deviation|Mean
99677|NCT00817843|Primary|Treatment Difference in (Postprandial-Fasting) FMD|A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg|After 6 weeks of treatment|Analyses were performed in randomized patients who received ≥1 dose of study treatment and who had a post-randomization analysis measurement||% (change FMD)||Standard Error|Mean
99678|NCT00817843|Secondary|Preprandial Endopat Measurement||after 6 weeks of treatment (crossover)||||||
99679|NCT00817843|Secondary|Preprandial Endothelial Function Measured by FMD||after 6 weeks of treatment (crossover)||||||
99680|NCT00817843|Secondary|Postprandial Endopat Measurement||after 6 weeks of treatment (crossover)||||||
99681|NCT00817804|Secondary|Blood Pressure|Systolic and diastolic blood pressure|30 minutes||||||
99682|NCT00817804|Secondary|Heart Rate|Beats per minute that the patient's heart is beating|30 minutes||||||
99683|NCT00817804|Secondary|Minute Ventilation|Liters per minute that the patient breathes|30 minutes||||||
99684|NCT00817804|Secondary|Respiratory Rate|Breathing rate in breaths per minute|30 minutes||12/2011||||
99685|NCT00817804|Secondary|Saturation of Arterial Oxygen||30 minutes||12/2011||||
99686|NCT00817804|Primary|Breathing Comfort|Comfort on visual analog scale 0 - 100, 0 is best|30 minutes|Analysis was per protocol||visual analog scale||Standard Error|Mean
99687|NCT00817778|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment|||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
99689|NCT00817778|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment|||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
99690|NCT00817778|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment|||L/h||Full Range|Geometric Mean
99691|NCT00817778|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the afternoon dose last day of treatment|||h||Full Range|Geometric Mean
99692|NCT00817778|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment|||h||Full Range|Median
99693|NCT00817778|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured last day of treatment|||umol/L||Standard Deviation|Geometric Mean
99694|NCT00817778|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment|||umol*h/L||Standard Deviation|Geometric Mean
99695|NCT00817778|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose|||Participants|||Number
99696|NCT00817778|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment|||kg||Standard Deviation|Mean
99697|NCT00817778|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||beats/min||Standard Deviation|Mean
99698|NCT00817778|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
99699|NCT00817778|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period|||mmHg||Standard Deviation|Mean
99700|NCT00817596|Primary|Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.|"Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient.~The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio."|6 months - acute study|Sample size was based on previous testing and data from similar devices. With a population of 60 subjects the 90% CI would be 95 ± 7, or 0.88 to 1.02. Therefore, approximately 60 patients with 6-months of data will provide adequate data to demonstrate accuracy, although up to 110 patients may be implanted to account for patient drop-outs.||% of programmed vol. actually delivered||90% Confidence Interval|Mean
99701|NCT00817531|Primary|Clinical Efficacy|The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), >=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), >= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.|Assessment at pre-surgery or 3 to 4 weeks of treatment.|All patients started the treatment will be included in the analysis||participants|||Number
99702|NCT00817479|Primary|Increase in MKP1/DuSP1 mRNA Expression Level|Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.||fold change||Standard Error|Mean
99703|NCT00817479|Primary|Increase in SGK1 mRNA Expression Level|Increase in SGK1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.||fold change||Standard Error|Mean
99704|NCT00817219|Secondary|PASI 50 at Week 4.|PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Week 4|||participants|||Number
99705|NCT00817219|Secondary|PASI 75 at Week 4.|PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|4 weeks|||participants|||Number
99706|NCT00817219|Secondary|Percentage Change in PASI From Baseline to Week 4.|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Baseline and 4 weeks|||percentage||95% Confidence Interval|Mean
99707|NCT00817219|Secondary|“Controlled Disease”(i.e., “Clear” or “Very Mild”) According to the Patient’s Global Assessment of Disease Severity at Week 4.|The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).|Week 4|||participants|||Number
99709|NCT00817219|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.||Baseline and 4 Weeks|||mmol/g||Standard Deviation|Mean
99711|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis||participants|||Number
99712|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis||participants|||Number
99713|NCT00817219|Primary|Adverse Drug Reactions|The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as “not related”.|Week 4|||participants|||Number
99714|NCT00817206|Primary|Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.||12 months|"One patient in each arm were randomized but not treated. Only treated patients (modified ITT population) is included in the primary outcome measure.~One patient death is listed under the Prograf arm; this patient died during follow up and did completet the study."||participants|||Number
99715|NCT00816907|Secondary|Change in Hemoglobin A1c From Baseline to 16 Weeks|glycosylated hemoglobin|16 weeks|participants who took assigned treatment||percent||95% Confidence Interval|Least Squares Mean
99716|NCT00816907|Secondary|Change in Fasting Insulin From Baseline to 16 Weeks|Fasting insulin|16 weeks|participants who took assigned treatment||mU/L||95% Confidence Interval|Mean
99717|NCT00816907|Secondary|Change in Fasting Glucose From Baseline to 16 Weeks|fasting blood glucose|16 weeks|participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
99718|NCT00816907|Secondary|Change in Triglycerides From Baseline to 16 Weeks|serum triglycerides|16 weeks|participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
99719|NCT00816907|Secondary|Change in LDL Cholesterol From Baseline to 16 Weeks|low-density lipoprotein|16 weeks|participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
99720|NCT00816907|Secondary|Change in HDL Cholesterol From Baseline to 16 Weeks|high-density lipoprotein|16 weeks|randomized participants who took assigned treatment||mg/dL||95% Confidence Interval|Least Squares Mean
99721|NCT00816907|Secondary|Change in Total Cholesterol From Baseline to 16 Weeks|Total cholesterol|16 weeks|randomized participants who took assigned treatment||mg/dL||95% Confidence Interval|Mean
99722|NCT00816907|Primary|Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo|Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)|Measured at the last study visit|Evaluable population that took assigned study treatment||kilograms||95% Confidence Interval|Mean
99723|NCT00816829|Primary|Index of Hypopneas|Average number of hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number per hour of sleep||Full Range|Median
99724|NCT00816829|Primary|Index of Apneas|Average number of apneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number per hour of sleep||Full Range|Median
99725|NCT00816829|Primary|Central Apneas|Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of central apneas||Full Range|Median
99726|NCT00816829|Primary|Mixed Apneas|Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of mixed apneas||Full Range|Median
99727|NCT00816829|Primary|Index Apnea/Hypopnea|Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number per hour of sleep||Full Range|Median
99728|NCT00816829|Primary|Hypopneas|Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of hypopneas||Full Range|Median
99729|NCT00816829|Primary|Apneas|Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of apneas||Full Range|Median
99730|NCT00816829|Primary|Sleep Time With Oxygen Saturation Below 90%|Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Percentage of sleep time||Full Range|Median
99731|NCT00816829|Primary|Desaturations|Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate).||Number of desaturations||Full Range|Median
99755|NCT00816023|Secondary|Treatment-emergent Adverse Events||Over the duration of the study.|Analysis conducted on Safety population, defined as all subjects randomized and received any study drug. Treatment groups are based on actual treatment received.||participants|||Number
99732|NCT00816829|Primary|Obstructive Apneas|Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).|at one month of treatment|The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).||Number of obstructive apneas||Full Range|Median
99733|NCT00816777|Secondary|Overall Survival||1 year||||||
99734|NCT00816777|Secondary|Performance Status (ECOG)||1 year||||||
99735|NCT00816777|Secondary|Change in Tumor Marker||1 year||||||
99736|NCT00816777|Secondary|Hepatic Progression Free Survival||1 year||||||
99737|NCT00816777|Secondary|Local Tumor Response (Extent of Necrosis in the Treated Lesions)||1 year||||||
99738|NCT00816777|Secondary|Tumor Response (RECIST)||1 year||||||
99739|NCT00816777|Secondary|Toxicity, Adverse Events and Serious Adverse Events (NCI CTCAE v3.0)||6 weeks||||||
99740|NCT00816777|Primary|Progression Free Survival||1 year||||||
99741|NCT00816595|Secondary|Progression-free Survival|The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.||months||95% Confidence Interval|Median
99742|NCT00816595|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.||months||95% Confidence Interval|Median
99743|NCT00816595|Primary|Complete and Overall Response Rate|"A Complete Response (CR) requires all of the following for 2 months:~Absence of lymphadenopathy by physical examination (PE)~No hepato- or splenomegaly by PE~Neutrophils >1500/ul, Platelets >100,000/ul. Hemoglobin >11.0 gm/dl, Peripheral blood lymphocytes <4000/uL~Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples.~A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available.~A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin.~Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients."|Evaluated after 6 cycles (up to 196 days)|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.||percentage of patients|||Number
99744|NCT00816556|Secondary|Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks|||pg/ml||Standard Deviation|Mean
99745|NCT00816556|Secondary|Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks|||pg/ml||Standard Deviation|Mean
99746|NCT00816556|Primary|Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12|The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.|baseline, 12 weeks|||units on a scale||Standard Deviation|Mean
99747|NCT00816348|Primary|Level of Bilirubin|measurement of bilirubin level weekly. Available data reported.|week 2, 3,4,and 8|||mg/dL||Standard Deviation|Mean
99748|NCT00816166|Primary|Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months|"The primary effectiveness endpoint was a composite of the two following outcomes:~Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization~Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization~A subject was deemed to be a primary endpoint success if neither of these outcomes occurred.~The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months)."|One Year|Analyses were based on an intent-to-treat (ITT) population, defined as enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and Medical Therapy Group subjects were analyzed according to their ITT randomized group regardless of treatment received.||percent probability||95% Confidence Interval|Number
99749|NCT00816101|Secondary|Erythema at Week 3|"At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with 0 being No erythema, 1 being Very slight erythema, 2 being Well defined erythema, 3 being Moderate to severe erythema and 4 being Severe erythema to slight eschar formation"|3 Weeks|||Erythema Scores on a Scale||Standard Deviation|Mean
99750|NCT00816101|Secondary|Number of Patients Reporting Pain|Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.|3 Weeks|||Participants|||Number
99751|NCT00816101|Primary|Number of Patients Who Experienced 50% or Greater Wound Healing|Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported|3 Weeks|||Participants|||Number
99756|NCT00816023|Primary|Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery||Start of surgery up to 12 hours after the end of surgery|The Modified Intent to Treat population was the basis of this analysis, defined as all randomized subjects who received any amount of study drug and analyzed according to the planned treatment assignment.||mL||Standard Deviation|Mean
99757|NCT00815919|Secondary|Overall and cGVHD Progression-free Survival by 1 Year After Therapy||2 years|||percentage of participants||95% Confidence Interval|Number
99758|NCT00815919|Secondary|Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy|Participants who were still being followed 1 year after the start of therapy had their prednisone dose recorded.|1 year after the start of study treatment|Participants who were still being followed 1 year after the start of therapy.||participants|||Number
99759|NCT00815919|Secondary|The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|Participants' toxicities were graded based on the CTCAE version 3.0. The toxicities were then given an attribution to the velcade treatment: unrelated, unlikely, possible, probable, definite.|Toxicities were collected from the start of treatment through 15 weeks of therapy or end of study treatmetn|||participants|||Number
99760|NCT00815919|Secondary|Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|The participants' total daily steroid dose was recorded at baseline and after a 15 week course of treatment. Starting at a dose of 0.5-1 mg/kg, dose reduction of steroids was permitted after 1 cycle of therapy. The suggested taper was 10-25% every 1-2 weeks. .|After 15 weeks of bortezomib plus prednisone therapy|Of the overall 22 patients, 18 patients completed 3 cycles (15 weeks) of therapy||participants|||Number
99761|NCT00815919|Primary|Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|"Participants had their cGVHD evaluated per NIH consensus criteria:~Complete response: resolution of all reversible manifestations of cGVHD.~Partial response: a decrease ≥ 1 point on a 3-point organ-specific scale or 2 points or more on a 10-point global scale without progression in any organ sites.~Stable disease: no evidence of cGVHD response without evidence of progressive cGVHD.~Progressive cGVHD: increase of ≥ 1 point on an organ-specific 3-point scale, addition of a new immunosuppressive agent prior to the completion of 15 weeks of combination therapy, or requirement an increase in the total daily dose of corticosteroids above a participant’s baseline corticosteroid dose during the 15-week combined treatment period.~Mixed response: a response in primary sites of cGVHD involvement but interval progressive cGVHD in other organs or sites.~Responses were not scored for oral or ocular cGVHD, since topical therapies were permitted during the study."|Patients had their cGVHD assessed at Baseline and at 15 weeks or end of therapy|||participants|||Number
99762|NCT00815776|Secondary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)|"The arm that includes 0 (Mouth Splint Group) is included in the Primary Outcome Measure."||Units on a scale||Standard Deviation|Mean
99763|NCT00815776|Primary|Number of Subjects With Adverse Events|Subjects were assessed for adverse events from the baseline visit through study completion (3 months post-baseline). Adverse events were categorized by the investigator for severity and relationship to treatment.|From Baseline through 3 months post-baseline visit.|||Participants|||Number
99764|NCT00815776|Primary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)|"The arm that includes 0 (Jaw Exercise) is reported in Seconary Outcome Measure Table."||Units on a scale||Standard Deviation|Mean
99765|NCT00815698|Secondary|Recurrence|recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.|12 months after surgery|||participants|||Number
99766|NCT00815698|Primary|Pain, Numbness and Discomfort in the Groin|The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.|12 months after surgery|||participants|||Number
99767|NCT00815685|Secondary|Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.|There is no expected range for “normal” activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.|6 weeks per patient|Participants with available pre and post-treatment serum samples.||Participants|||Number
99768|NCT00815685|Primary|Change in Serum Albumin|Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.|6 weeks per patient|||g/dL||Full Range|Median
99769|NCT00815659|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events in 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Number of patients with any adverse events in 3 months||Participants|||Number
99770|NCT00815659|Secondary|Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants||mg/mL||Standard Deviation|Mean
99771|NCT00815659|Secondary|Basal Small HDL Subfraction Level|Small HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Small HDL subfraction of participants||mg/mL||Standard Deviation|Mean
99772|NCT00815659|Secondary|Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants||mg/mL||Standard Deviation|Mean
99773|NCT00815659|Secondary|Basal Intermediate HDL Subfraction Level|Intermediate HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Intermediate HDL subfraction of participants||mg/mL||Standard Deviation|Mean
99774|NCT00815659|Secondary|Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants||mg/mL||Standard Deviation|Mean
99775|NCT00815659|Secondary|Basal Large HDL Subfraction Level|Large HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Large HDL subfraction of participants||mg/mL||Standard Deviation|Mean
99776|NCT00815659|Secondary|LDL-7 Level After 3 Months of Rosuvastatin Treatment|LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-7 levels of participants||mg/mL||Standard Deviation|Mean
99777|NCT00815659|Secondary|Basal LDL-7 Level|LDL-7 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-7 levels of participants||mg/mL||Standard Deviation|Mean
99778|NCT00815659|Secondary|LDL-6 Level After 3 Months of Rosuvastatin Treatment|LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-6 levels of participants||mg/mL||Standard Deviation|Mean
99779|NCT00815659|Secondary|Basal LDL-6 Level|LDL-6 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-6 levels of participants||mg/mL||Standard Deviation|Mean
99780|NCT00815659|Secondary|LDL-5 Level After 3 Months of Rosuvastatin Treatment|LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-5 levels of participants||mg/mL||Standard Deviation|Mean
99781|NCT00815659|Secondary|Basal LDL-5 Level|LDL-5 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-5 levels of participants||mg/mL||Standard Deviation|Mean
99782|NCT00815659|Secondary|LDL-4 Level After 3 Months of Rosuvastatin Treatment|LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF(Last Observation Carried Forward) LDL-4 levels of participants||mg/mL||Standard Deviation|Mean
99783|NCT00815659|Secondary|Basal LDL-4 Level|LDL-4 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-4 levels of participants||mg/mL||Standard Deviation|Mean
99784|NCT00815659|Secondary|LDL-3 Level After 3 Months of Rosuvastatin Treatment|LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-3 levels of participants||mg/mL||Standard Deviation|Mean
99785|NCT00815659|Secondary|Basal LDL-3 Level|LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls|Baseline|Baseline LDL-3 levels of participants||mg/mL||Standard Deviation|Mean
99786|NCT00815659|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment|hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants||mg/mL||Standard Deviation|Mean
99787|NCT00815659|Secondary|Basal High Sensitivity C-reactive Protein (Hs-CRP) Level|hs-CRP levels before (Visit 2-enrollment)|Baseline|Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants||mg/mL||Standard Deviation|Mean
99788|NCT00815659|Secondary|Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment|TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants||pg/mL||Standard Deviation|Mean
99789|NCT00815659|Secondary|Basal Tumor Necrosis Factor (TNF) Level|TNF levels before (Visit 2-enrollment)|Baseline|Baseline Basal Tumor Necrosis Factor (TNF) levels of participants||pg/mL||Standard Deviation|Mean
99790|NCT00815659|Secondary|Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment|IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-10 levels of participants||pg/mL||Standard Deviation|Mean
99791|NCT00815659|Secondary|Basal Interleukin 10 (IL-10) Level|IL-10 levels before (Visit 2-enrollment)|Baseline|Baseline IL-10 levels of participants||pg/mL||Standard Deviation|Mean
99792|NCT00815659|Secondary|Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment|IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-8 levels of participants||pg/mL||Standard Deviation|Mean
99793|NCT00815659|Secondary|Basal Interleukin 8 (IL-8) Level|IL-8 levels before (Visit 2-enrollment)|Baseline|Baseline IL-8 levels of participants||pg/mL||Standard Deviation|Mean
99794|NCT00815659|Secondary|Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment|IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-6 levels of participants||pg/mL||Standard Deviation|Mean
99795|NCT00815659|Secondary|Basal Interleukin 6 (IL-6) Level|IL-6 levels before (Visit 2-enrollment)|Baseline|Baseline IL-6 levels of participants||pg/mL||Standard Deviation|Mean
99796|NCT00815659|Secondary|Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment|IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-1 levels of participants||pg/mL||Standard Deviation|Mean
99797|NCT00815659|Secondary|Basal Interleukin 1 (IL-1) Level|IL-1 levels before (Visit 2-enrollment)|Baseline|Baseline IL-1 levels of participants||pg/mL||Standard Deviation|Mean
99798|NCT00815659|Primary|Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Non-HDL cholesterol target levels <130 mg/dL, calculated over patients with lipid measurement performed at both visits||Participants|||Number
99799|NCT00815659|Primary|Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|HDL cholesterol target levels for males >40 mg/dL, for females > 50 mg/dL, calculated over patients with lipid measurement performed at both visits||Participants|||Number
99800|NCT00815659|Primary|Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL|3 months (from enrollment to last visit)|LDL cholesterol levels < 100 mg/dL, calculated over patients with lipid measurement performed at both visits||Participants|||Number
99801|NCT00815659|Primary|Triglyceride Level After 3 Months of Rosuvastatin Treatment|Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) triglyceride levels of participants||mg/dL||Standard Deviation|Mean
99802|NCT00815659|Primary|Basal Triglyceride Level|Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline triglyceride levels of participants||mg/dL||Standard Deviation|Mean
99803|NCT00815659|Primary|Total Cholesterol Level After 3 Months of Rosuvastatin Treatment|Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) total cholesterol levels of participants||mg/dL||Standard Deviation|Mean
99804|NCT00815659|Primary|Basal Total Cholesterol Level|Baseline|Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline total cholesterol levels of participants||mg/dL||Standard Deviation|Mean
99805|NCT00815659|Primary|LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL levels of participants||mg/dL||Standard Deviation|Mean
99806|NCT00815659|Primary|Basal LDL-cholesterol Level|LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline LDL levels of participants||mg/dL||Standard Deviation|Mean
99807|NCT00815659|Primary|HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) HDL levels of participants||mg/dL||Standard Deviation|Mean
99808|NCT00815659|Primary|Basal HDL-cholesterol Level|HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|||mg/dL||Standard Deviation|Mean
99809|NCT00814892|Secondary|Progression Free Survival (PFS)|PFS based on radiographic criteria was defined as the time from registration to the time of radiographic progression. A confirmed progression was defined as one for which radiological evidence of a new lesion is found following CT and/or bone scans.|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
99810|NCT00814892|Secondary|Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire|"European Orgnisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 for cancer patients composed of 5 functional scales, 3 symptom scales, a global health status QOL scale, and six single items. Scores for each scale/item were calculated according to the questionnaire's scoring algorithm and range in 0 to 100, with high score represents high healthy level of functioning, high QOL or high level of symptomatology/problems. Change: Scores at cycle 1 minus scores at baseline.~Change from baseline in QOL will also be evaluated at cycle 6, 10, 15 and every 6 months during observation phase."|Baseline and cycle 1|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
99811|NCT00814892|Secondary|Duration of PSA-based Response|"PSA-based response was defined as a PSA decline of at least 50%, which must be confirmed by a second PSA value in 4 or more weeks later.~The duration of PSA-based response are measured from the first time point at which the PSA has declined by at least 50% (which must eventually be confirmed by a second value) until PSA has increased back to 50% of the original on-study value."|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
99812|NCT00814892|Secondary|Time to Prostate-specific Antigen (PSA) Progression|"In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value. In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.~The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response). For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved (see above). All end dates require a confirmatory PSA."|Registration to PSA progression (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
99813|NCT00814892|Secondary|Time to Prostate-cancer Specific Mortality||Registration to Prostate-cancer specific mortality (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
99814|NCT00814892|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 14 cycles)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
99815|NCT00814892|Primary|Number of Participants Who Are Progression Free at One Year|Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level <200.0 ng/mL.|One year|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.|||||
99816|NCT00814879|Secondary|Mean Change in Total Bilirubin (mg/dL) From Baseline|mean change in total bilirubin from baseline|baseline and 48 weeks|||mg/dL||Standard Deviation|Mean
99817|NCT00814879|Secondary|Cholesterol|Total cholersterol (mg/dL)|baseline, week 24, week 48|||mg/dL||Standard Deviation|Mean
99818|NCT00814879|Secondary|CD4+ Cell Count||Week 48|||cells/mm^3||Standard Deviation|Mean
99819|NCT00814879|Secondary|CD4+ Cell Count||Weeks 24|||cells/mm^3||Standard Deviation|Mean
99820|NCT00814879|Secondary|Number of Patients With < 400 Copies HIV RNA/mL at Week 48||48 weeks|||participants|||Number
99821|NCT00814879|Primary|Number of Patients Reaching Virologic Failure at Week 48.|Virologic failure was defined by protocol as a plasma HIV RNA >50 c/mL on 2 consecutive occasions >7 days apart or > 10 000 c/mL on one occasion (in the absence of an intercurrent infection or recent immunization).|48 Weeks|||participants|||Number
99822|NCT00814801|Secondary|Change From Baseline in the Mental Function Impairment Scale (MENFIS)|MENFIS is a Clinician's Interview-Based Impression of Change (CIBIC) plus-Japan subscale that rates the patient's severity for mental function impairment. This seven-point scale varies from 0 (= absolutely no impairment) to 6 (=complete impairment).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
99823|NCT00814801|Secondary|Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|Behave-AD is a CIBIC plus-J subscale that rates the patient's severity of psychotic symptoms. This four-point scale varies from 0 (=none) to 3 (= serious).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
99824|NCT00814801|Secondary|Change From Baseline in the Disability Assessment for Dementia (DAD)|Each of the 40 item of the DAD is scored as 1 point= Yes, 0 point= No, or non applicable= N/A. A total score (minimum=0; maximum=40) is the sum of points for each questions converted out 100. Items rated as Not Applicable (N/A) are not considered for the total score. The final score is a percentage that gives an appreciation of global function in activity of daily life (ADL). Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
99825|NCT00814801|Primary|Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from markedly improved” to “markedly worse”."|24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||patients|||Number
99826|NCT00814801|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.||Scores on a scale||Standard Deviation|Mean
99827|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy||60 seconds|||seconds||Inter-Quartile Range|Median
99828|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy||from start of intubation to successfully intubated|||seconds||Inter-Quartile Range|Median
99829|NCT00814710|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following first vaccination (Month 0) throughout the entire study period (month 3)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
99830|NCT00814710|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms"|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
99831|NCT00814710|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. However, the total number of subjects analyzed in this Total Vaccinated cohort included all subjects having returned their symptom sheets.||subjects|||Number
99832|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)|Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
99833|NCT00814710|Primary|Concentration of Antibody Against Protein D (PD)|Concentrations were expressed as GMCs GSK’s 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||EL.U/mL||95% Confidence Interval|Geometric Mean
99834|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)|"Seroprotection was defined as:~Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
99835|NCT00814710|Secondary|Number of Subjects Seropostive for B. Pertussis|Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
99836|NCT00814710|Secondary|Concentration of Antibody Against Hepatitis B (Anti-HBs)|Concentration was expressed as GMC in milli international units per milliliter (mIU/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||mIU/mL||95% Confidence Interval|Geometric Mean
99837|NCT00814710|Secondary|Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)|Concentration was expressed as GMC in EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||EL.U/mL||95% Confidence Interval|Geometric Mean
99838|NCT00814710|Secondary|Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)|Concentrations were expressed as GMCs in international units per milliliter (IU/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||IU/mL||95% Confidence Interval|Geometric Mean
99839|NCT00814710|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentration is expressed as GMC in µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||µg/mL||95% Confidence Interval|Geometric Mean
99840|NCT00814710|Secondary|Number of Subjects Seropositive for Protein D (PD)|Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
99841|NCT00814710|Secondary|Number of Subjects Seropositive for Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.~Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL"|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
99842|NCT00814710|Secondary|Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes|Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||µg/mL||95% Confidence Interval|Geometric Mean
99843|NCT00814710|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.~The cut-off was defined as 0.20 microgram per milliliter (µg/mL)."|One month after primary immunization|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
99844|NCT00814710|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Cross-reactive pneumococcal serotypes included 6A and 19A.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||subjects|||Number
99845|NCT00814710|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).~Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.||µg/mL||95% Confidence Interval|Geometric Mean
99846|NCT00814697|Primary|Cognitive Assessment Task Scores Before, During and After rTMS.|"Cognitive assessment tasks - Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), Mini-Mental State Examination (MMSE) - were administered and scored according to standard procedures before, during and 4 weeks after rTMS.~Higher scores are associated with better cognition; No absolute cut-offs were used here as the outcomes were not categorically assessed.~Total possible score ranges by test, lowest to highest:~BDAE - 0 to 15 CFL - 0 to 62 MMSE - 0 to 30 Full range data and means presented below represents range of scores at 4-weeks post-rTMS treatments."|6 weeks|||units on a scale||Full Range|Mean
99847|NCT00814671|Secondary|To Compare Lowenstein Jensen and Bactec MGIT Media With Respect to Proportion of Participants With 8-week Culture Conversion and Time to Culture Conversion||8 weeks||||||
99848|NCT00814671|Secondary|To Determine if Rifapentine Exposures Are Associated With Safety||10 weeks||||||
99849|NCT00814671|Secondary|To Determine if Rifapentine Exposures Are Associated With Microbiological Activity||8 weeks||||||
99850|NCT00814671|Secondary|To Describe the Pharmacokinetics of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment||4 weeks||||||
99851|NCT00814671|Secondary|To Evaluate the Microbiological Activity of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment, Based on Time to Culture Growth in MGIT Liquid Media||8 weeks||||||
99853|NCT00814671|Primary|To Estimate the Frequency of Side Effects of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg in the Context of Multidrug Intensive Phase TB Treatment|discontinuation of treatment|10 weeks|safety analysis population||percentage of participants|||Number
99854|NCT00814671|Primary|To Estimate the Microbiological Activity of Rifapentine Administered at Once Daily Doses of 450 mg and 600 mg Based on Proportion of Participants With Culture Conversion||8 weeks|per protocol||percentage of participants w/LJ cx con|||Number
99855|NCT00814658|Secondary|The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24|The NPI evaluates 12 neuropsychiatric domains: delusions, hallucinations, dysphoria, anxiety, aggression, euphoria, dis-inhibition, irritability/lability, apathy, aberrant motor activity, eating disorders, and night-time behavior disturbances. For present domains, the severity and frequency of the behavior are determined. Frequency is rated 1 (rarely) to 4 (very often) and Severity is scored 1 (mild) to 3 (severe). The product scores vary from 1 (mild and rarely) to 12 (very often and severe). Total scores vary from 0 (no present domain) to 144 (all domains are present, are often and severe).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
99856|NCT00814658|Secondary|The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24|The Clinical Global Impression (CGI) is a scale to assess treatment response in patients with mental disorders. The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Week 4, Week 8, Week 16, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||participants|||Number
99857|NCT00814658|Secondary|The Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
99858|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer’s Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer’s disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
99859|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer’s Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer’s disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
99860|NCT00814658|Primary|The Quality of Life Assessment for Caregivers of Patients With Alzheimer’s Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for caregivers of patients with Alzheimer’s disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||scores on a scale||Standard Deviation|Mean
99861|NCT00814658|Primary|Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24|The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient’s reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
99862|NCT00814658|Primary|Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24|The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
99908|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.|36 Months|Intention-to-Treat||percentage of participants|||Number
99863|NCT00814658|Primary|Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24|The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient’s right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
99864|NCT00814658|Primary|Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24|The Simple Reaction Time is a computerized attention test that evaluates the patient’s reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient’s finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.||milliseconds||Standard Deviation|Mean
99865|NCT00815516|Secondary|Plasma Micafungin Concentration||15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV|The pharmacokinetics (PK) analysis set, including those infants who received any amount of study drug, have at least one study drug concentration, and have dosing and blood collection date and time data sufficient for inclusion in a population pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
99866|NCT00815516|Secondary|Follow-up Status for Infants With End-organ Assessments|"End-organ dissemination was assessed through abdominal ultrasound and/or computed tomography (CT), echocardiogram, head imaging and retinal exam. Each specific finding, documented by 1 of these techniques, was evaluated as follows:~Improvement: Improvement in size, number or density of identified lesions. Complete response was not expected but may have been documented.~Stabilization: Minor improvement or no change in size, number or density of identified lesions.~Worsening: Increase in size or number of identified lesions."|Baseline and 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with end-organ assessments||percentage of participants|||Number
99867|NCT00815516|Secondary|Mycological Response One Week After Last Dose of Study Drug|"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site."|One week after the last dose of study drug (maximum of 49 days)|Full analysis set||percentage of participants|||Number
99868|NCT00815516|Secondary|Mycological Response at End of Study Drug Therapy|"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site."|End of study drug therapy; maximum of 42 days|Full analysis set||percentage of participants|||Number
99869|NCT00815516|Secondary|Clinical Response One Week After Last Dose of Study Drug|"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and one week after the last dose of study drug (maximum of 49 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline||percentage of participants|||Number
99870|NCT00815516|Secondary|Clinical Response at the End of Study Drug Therapy|"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and end of study drug therapy; maximum of 42 days|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline||percentage of participants|||Number
99871|NCT00815516|Secondary|Time to Positive Clinical Response|"Time to a positive clinical response is defined as the time from the first dose to the day during the treatment period that a positive clinical response (defined as a complete response or partial response) is observed for the first time, assessed by the Investigator.~Complete Response is defined as the resolution of all attributable signs related to fungal infection, if present at baseline and Partial Response is defined as improvement in attributable signs related to the fungal infection, if present at baseline.~Infants without positive responses and who survived were censored at one day post the end of treatment. Infants without positive responses who died before completing the treatment period, or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline||days||95% Confidence Interval|Median
99909|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.|24 Months|Intention-to-Treat (ITT)||percentage of participants|Participants||Number
99872|NCT00815516|Secondary|Percentage of Participants With Recurrent Fungal Infections|A recurrent infection is defined as a systemic fungal infection in an infant with eradication at the end of study drug therapy, who developed positive blood cultures or a mycologically confirmed deep-seated Candida infection, with the same species as the enrolling infection.|Up to 30 days after the last dose of study drug (maximum of 72 days)|Participants in the full analysis set with eradication at the end of study drug therapy.||percentage of participants||95% Confidence Interval|Number
99873|NCT00815516|Secondary|Percentage of Participants With Emergent Fungal Infections|"An emergent fungal infection is defined as~An invasive fungal infection which is detected at any time during the study that is a non-Candida organism, or~An invasive fungal infection which is detected during the treatment or post-treatment period with a Candida species identified other than those detected at Baseline. If this occurred within 96 hours of the first dose of study drug, the infection was considered part of the final diagnosis of enrolling infection and not an emergent infection."|Up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set||percentage of participants||95% Confidence Interval|Number
99874|NCT00815516|Secondary|Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive one week after last dose of study drug with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|One week after the last dose of study drug (maximum of 49 days)|Participants in the full analysis set with end-organ dissemination||percentage of participants||95% Confidence Interval|Number
99875|NCT00815516|Secondary|Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at the end of study drug therapy with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|The end of study drug therapy; maximum of 42 days|Participants in the full analysis set with end-organ dissemination||percentage of participants||95% Confidence Interval|Number
99876|NCT00815516|Secondary|Time to Mycological Clearance of Invasive Candidiasis|"Time to mycological clearance of invasive candidiasis is defined as the time from first dose to the day of mycological eradication for baseline invasive candidiasis infection.~Eradication was defined as a culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for for Candida meningitis and/or candiduria, 1 negative culture.~Infants without eradication during the treatment period and who survived were censored at one day after the end of treatment. Infants without eradication who died before completing the treatment period or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set||days||95% Confidence Interval|Median
99877|NCT00815516|Primary|Fungal-free Survival|"Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment.~Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture."|One week after the last dose of study drug (maximum of 49 days)|Full Analysis Set (all randomized infants who were administered any amount of study drug)||percentage of participants||95% Confidence Interval|Number
99878|NCT00815490|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.||percentage saturation||Full Range|Mean
99879|NCT00815360|Secondary|Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months||6 months|||units on a scale (microns)|Participants|95% Confidence Interval|Mean
99880|NCT00815360|Primary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.||6 months|We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on UWFA.||Letters of visual acuity on ETDRS chart|Participants|95% Confidence Interval|Mean
99881|NCT00815347|Secondary|Asthma Control Test Questionnaire|Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)|end of each dosing period|||scores on a scale||Standard Deviation|Mean
99882|NCT00815347|Other Pre-specified|Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry.||17 weeks||||||
99883|NCT00815347|Other Pre-specified|Requirement for Urgent Medical Care for Asthma.||17 weeks||||||
99884|NCT00815347|Other Pre-specified|Requirement for Escalation of Controller Medication.||17 weeks||||||
99885|NCT00815347|Secondary|Rescue Beta-agonist||end of each dosing period|||puffs of rescue inhaler||Standard Deviation|Mean
99886|NCT00815347|Secondary|FEV1||end of dosing period|||liters||Standard Deviation|Mean
99887|NCT00815347|Primary|Symptom Scores|Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms)|Last 7 days of each dosing period|||score on a scale||Standard Deviation|Mean
99888|NCT00815347|Primary|Peak Flow||last 7 days of each dosing period|Data not analyzed, study terminated early|||||
99889|NCT00815347|Primary|Change in FEV1||1, 2, 4 hours after dosing|||liters||95% Confidence Interval|Mean
99890|NCT00815308|Secondary|Number of Participants With K-ras Gene Mutation|DNA was extracted from tumor specimens.Screened for the presence of KRAS codon 12 and 13 mutations using a PCR clamping and melting curve technique. PCR amplification of the wild-type KRAS sequence was suppressed in this process by the incorporation in the reaction mix of a locked nucleic-acid oligomer16 spanning codons 12 and 13 of the KRAS gene. Post-PCR hybridization and melting curve analysis using fluorescently tagged oligonucleotides incorporated in the original PCR reaction permitted the identification and discrimination of distinct KRAS codon 12 and 13 missense mutations.|07/29/2010-09/30/2010|||participants|||Number
99891|NCT00815308|Secondary|Participants With Progression Free Survival (PFS)||Recurrence or metastasis from the date of diagnosis||08/2013||||
99892|NCT00815308|Secondary|Participants With Overall Survival (OS) at 3 Year||3 year from the date of diagnosis||08/2013||||
99893|NCT00815308|Secondary|Participants With Overall Survival (OS) at 1 Year||1 year from the date of diagnosis||08/2011||||
99894|NCT00815308|Secondary|Number of Participants With Toxicity|All patients were regularly monitored for possible adverse events, which were graded according to National Cancer Institute Common Toxicity Criteria version 3.0.|Every week during treatment and 1 month after therapy|||participants|||Number
99895|NCT00815308|Primary|Number of Participants With Overall Response Rate (RR)|The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3–6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|1 to 3 month after therapy|||participants|||Number
99896|NCT00815295|Secondary|Phase 2 - Mean Change From Baseline in Quality of Life - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)|The outcome measure is the mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the FACT-H&N. The instrument consists of 39 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-bing (FWB) and additional head and neck specific concerns (HNCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and HNCS scores (12 items). TOI ranges from 0 to 140.|5 years|QOL data were not consistently collected and can not be analyzed.|||||
99897|NCT00815295|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or death due to any cause. Per RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years|||months||95% Confidence Interval|Number
99898|NCT00815295|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.||months||95% Confidence Interval|Number
99899|NCT00815295|Primary|Tumor Control Rate|The proportion of patients for whom the best overall response is complete response (CR), partial response (PR) or stable disease (SD). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. If follow-up assessments are not available, the best overall response is unevaluable.|1 year|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.||percentage of participants||95% Confidence Interval|Number
99900|NCT00815295|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Sorafenib Administered With Cetuximab (400 mg/m2 Loading Dose Followed by 250 mg/m2 Weekly)|The MTD is based upon dose-limiting (DLTs) experienced during Cycle 1 of treatment. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience DLT. Using Common Toxicity Criteria for Adverse EVents (CTCAE) version 3.0, DLTs are defined as any Grade 4 hematologic toxicity, or Grade 3 or 4 non-hematologic toxicity. A DLT will not be considered to have occurred in the case of a grade 3 or 4 allergic reaction due to cetuximab.|Cycle 1 (28 Days)|All patients treated on either dose level 1 or 2 as part of the phase I study.||mg|||Number
99901|NCT00815191|Primary|Intraoperative Distal Esophageal (Core) Temperature||at 1 hour|||°C||Standard Error|Mean
99902|NCT00815087|Secondary|Questionnaire of Life Quality||1 to 3 months||||||
99903|NCT00815087|Primary|The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months|A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.|Averaged 2 months|||cm/s||Standard Deviation|Mean
99904|NCT00814983|Secondary|Rate of Immune Recovery|The time to recovery of T-cell subset, B cell and NK cell recovery will be monitored along with T-Cell proliferative response to mitogens.|3 years|No analysis was performed since the experimental arm was not opened|||||
99905|NCT00814983|Primary|Disease Free Survival||One year|No analysis was performed since the experimental arm was not opened|||||
99906|NCT00814983|Primary|The Incidence of Grade II-IV Acute Graft Versus Host Disease||One year from date of transplant|No analysis was performed since the experimental arm was not opened|||||
99907|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.|36 Months|Intention-to-Treat||percentage of participants|Participants||Number
99910|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.|24 Months|Intention-to-Treat||percentage of participants|||Number
99911|NCT00814970|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rate|Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
99912|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.|12 Months|Intention-to-Treat (ITT)||percentage of participants|Participants||Number
99913|NCT00814970|Secondary|Change in Quality of Life - Decrease in Rutherford Class >= 1 Category|Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|30 Days|Intention-to-Treat (ITT)||percentage of participants|||Number
99914|NCT00814970|Secondary|Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15|Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
99915|NCT00814970|Secondary|Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category|Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|12 months|Intention-to-Treat (ITT)||percentage of participants|||Number
99916|NCT00814970|Secondary|Secondary Patency Rate|Defined as vessel patency resulting from any procedure that restores patency.|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
99917|NCT00814970|Secondary|Assisted Primary Patency|Defined as vessel patency resulting from a procedure performed in the treated segment.|12 months|Intention-to-Treat (ITT)||percentage of participants|||Number
99918|NCT00814970|Secondary|Procedure Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.|At time of deployment to time of hospital discharge|Intention-to-Treat (ITT)||percentage of lesions treated|||Number
99919|NCT00814970|Secondary|Lesion Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)||percentage of lesions treated|||Number
99920|NCT00814970|Secondary|Device Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)||percentage of lesions treated|||Number
99921|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.|6 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
99922|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.|30 days|Intention-to-Treat (ITT)||percentage of participants|||Number
99923|NCT00814970|Primary|Primary Patency Rate|Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).|12 Months|Intention-to-Treat (ITT)||percentage of participants|||Number
99924|NCT00814970|Primary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.|12 Months|Intent-to-Treat Population||percentage of participants|||Number
99925|NCT00814632|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.~The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks|||participants|||Number
99926|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99927|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
100361|NCT00812461|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS||units on a scale||Standard Error|Mean
99928|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99929|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99930|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99931|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99932|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99933|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99934|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99935|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99936|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99937|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99938|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99939|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).||participants|||Number
99940|NCT00814580|Secondary|Summary of Medical Resource Utilization – Number of Other Types of Contacts With Healthcare Professionals|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population||Number of participants|||Number
99941|NCT00814580|Secondary|Summary of Medical Resource Utilization – Number of Calls by the Subject to Study Site Personnel|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population||Number of calls|||Number
99942|NCT00814580|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population||percentage of participants|||Number
99943|NCT00814580|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population||percentage of participants|||Number
99944|NCT00814580|Secondary|Subject Satisfaction With Treatment|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied|7 Days|Intent-to-Treat Population||percentage of participants|||Number
99945|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99946|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99947|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99948|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99949|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99950|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99951|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99952|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99953|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 7|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population||percentage of participants|||Number
99954|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 3|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population||percentage of participants|||Number
100567|NCT00811018|Primary|Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)|PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
99955|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 7|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population||percentage of participants|||Number
99956|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 3|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population||percentage of participants|||Number
99957|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population||Hours||95% Confidence Interval|Median
99958|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population||Hours||95% Confidence Interval|Median
99959|NCT00814580|Primary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).||Scores on a scale||Standard Deviation|Mean
99960|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.~This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
99961|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.~This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
99962|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|"The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations:~C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17)."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.||T-cells/million cells||Standard Deviation|Mean
99963|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|"The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations:~Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.||T-cells/million cells||Standard Deviation|Mean
99964|NCT00814489|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)|Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.|Days 0, 30, 60, 90, 180 and 420.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.||LU/mL||95% Confidence Interval|Geometric Mean
99965|NCT00814489|Primary|Number of Subjects With Any Biochemical Laboratory Abnormalities|"Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE).~Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
99966|NCT00814489|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 420|The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented.||Subjects|||Number
99967|NCT00814489|Primary|Number of Subjects With Any Unsolicited Adverse Events (AE)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|During a 30-day (Days 0-29) follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
99968|NCT00814489|Primary|Number of Subjects With Any Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade.~Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination."|During a 7-day follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.||Subjects|||Number
99969|NCT00814463|Secondary|Overall Survival||12 months||||||
99970|NCT00814463|Secondary|Rate of Death Due to Neurologic Causes||12 months||||||
99971|NCT00814463|Secondary|Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)||12 months||||||
99972|NCT00814463|Secondary|Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam||Every 3 months for 12 months.||||||
99973|NCT00814463|Secondary|Quality of Life as Measured by the FACT-Br Subscales||Every 3 months for 12 months||||||
99974|NCT00814463|Secondary|Rate of New Brain Metastases Outside of the Adjuvant SRS Site||12 months||||||
99975|NCT00814463|Secondary|Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery||12 months||||||
99976|NCT00814463|Primary|Recurrence Rate at the Surgical Site as Measured by MRI|The number of months for local recurrence via MRI|12 months|||Months|||Number
99977|NCT00814346|Secondary|Change in Brain Morphology in the MC and CNE Groups as Determined by the Change in Voxel Size|Evolution of brain morphology (degree of cortical atrophy) after 18 months with EGb761, using MRI voxel based morphometry|From Baseline (Month 0) to Month 18|ITT population.||mm3||Full Range|Median
99978|NCT00814346|Secondary|Incidence of Adverse Events (AEs)|"The relationship of an adverse event to the study medication will be classified according to the following criteria:~Related : reports including good reasons and sufficient information (e.g. temporal relationship, dose-response relationship, pharmacology, positive de-challenge and/or re-challenge) to assume a causal relationship with the study drug in the sense that it is plausible, conceivable, or likely~Not related: reports including good reasons and sufficient information (e.g. no temporal relationship and/or attributable to concurrent disease or other drugs) to rule out a causal relationship with the study drug."|Up to Month 18|Safety population. CNE patients withdrew during the double-blind phase and were also not included in the safety population for open phase (17 months).||participants|||Number
99979|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 18|ITT population. N=Number of subjects with assessment.||participants|||Number
99980|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.|At Month 18|ITT population. N=Number of subjects with assessment.||participants|||Number
99981|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform TMT in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.~First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Seconds||Full Range|Median
99982|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted WAIS in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.~Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
99983|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.~Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
99984|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of FCSRT|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.~Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.~Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.~Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Recall score||Full Range|Median
99985|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.~The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Cube drawing test score||Full Range|Median
99986|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Clock drawing test score||Full Range|Median
99987|NCT00814346|Secondary|Change in Cognitive Tests-MMSE Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||MMSE Score||Full Range|Median
99988|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.~Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.~Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||Number of good answers||Full Range|Median
99989|NCT00814346|Secondary|Change in Cognitive Tests-GDS Score in MC and CNE Groups|The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By “yes” or “no” answers, scores permit to classify patients into groups of “severely depressed” (score of 21 to 30), “moderately depressed” (score of 11 to 20) and “normal” (score of 0 to10). It takes10 to 15 minutes to administer.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||GDS Score||Full Range|Median
99990|NCT00814346|Secondary|Change in Cognitive Tests-CDR Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3)|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||CDR overall score||Full Range|Median
99991|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 9|ITT population. N=Number of subjects with assessment.||participants|||Number
100139|NCT00813995|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||mg/dL||95% Confidence Interval|Least Squares Mean
99992|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|"The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.~National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA)"|At Month 9|ITT population. N=Number of subjects with assessment||participants|||Number
99993|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform Trail Making Test (TMT) in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.~First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.~The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Seconds||Full Range|Median
99994|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS) in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.~Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
99995|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.~Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Age adjusted score||Full Range|Median
99996|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of the Free and Cued Selective Reminding Test (FCSRT)|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.~Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.~Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.~Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Recall score||Full Range|Median
99997|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.~The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Cube drawing test score||Full Range|Median
99998|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Clock drawing test score||Full Range|Median
99999|NCT00814346|Secondary|Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||MMSE Score||Full Range|Median
100000|NCT00814346|Primary|Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)|"Following statistical parametric mapping (SPM) analyses were performed by the Commissariat à l’Energie Atomique (CEA):~The comparison between treatment groups separately for each group of elderly subjects (CNE and MC groups only)~The comparison between the two groups of elderly subjects (CNE and MC groups only) by treatment group~FDG PET demonstrates reductions in the cerebral glucose metabolism that may occur a few years before the overt clinical manifestation of disease.~SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]~BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80~Standardized Uptake Value (SUV) Body Surface Area (BSA)"|From Baseline (Month 0) to Week 4 (Month 1) - Double blind phase|Intention to treat (ITT) population: All treated CNE and MC patients||SUVBSA2||Full Range|Median
100001|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.~Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.~Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||Number of good answers||Full Range|Median
100002|NCT00814346|Secondary|Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups|The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By “yes” or “no” answers, scores permit to classify patients into groups of “severely depressed” (score of 21 to 30), “moderately depressed” (score of 11 to 20) and “normal” (score of 0 to10). It takes10 to 15 minutes to administer.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||GDS Score||Full Range|Median
100003|NCT00814346|Secondary|Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3).|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.||CDR overall score||Full Range|Median
100004|NCT00814346|Secondary|Change in Brain Glucose Metabolism in the MC and CNE Groups|"Brain glucose metabolism measured by 18FDG PET~SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]~BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80"|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.||SUVBSA2||Full Range|Median
100005|NCT00814333|Primary|Cessation of Epistaxis||baseline, day 4-6|No participants started treatment on this study. Study was closed before any study related procedures were administered.|||||
100006|NCT00814320|Secondary|Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs’ test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)|||Percentage of participants|||Number
100007|NCT00814320|Secondary|Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs’ test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)|||Number of participants|||Number
100008|NCT00814320|Secondary|Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of participants|||Number
100009|NCT00814320|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set||Number of participants|||Number
100010|NCT00814320|Secondary|Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion|"Temporally associated defined as during infusion or within 72 hours of completion of infusion.~Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]).~Expressed as a percentage."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of AE|Participants|95% Confidence Interval|Median
100011|NCT00814320|Secondary|Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)|"Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%.~The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
100012|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs|"Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, [administered via intravenous (IV) or subcutaneous (SC) route], recombinant human hyaluronidase (rHuPH20) or both.~The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
100013|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant|||Number
100014|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant|||Number
100015|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant|||Number
100192|NCT00813748|Primary|Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event – Case Participants|Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100016|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
100017|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
100018|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants||Number
100019|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs|||Number
100020|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs|||Number
100021|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs|||Number
100022|NCT00814320|Secondary|Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment)|Frequency of dose corrections based on immune globulin G (IgG) trough levels <4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of participants|||Number
100023|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of infusions|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per infusion|Participants|95% Confidence Interval|Median
100024|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of participants|Throughout the study period (17 months)|Safety Analysis Data Set||Number of AEs per participant||95% Confidence Interval|Median
100025|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE At Any Time During the Study|Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
100026|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
100027|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study|Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study|At any time during the study|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
100028|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of IV and SC (with recombinant human hyaluronidase [rHuPH20]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
100029|NCT00814320|Secondary|Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Participants exposed to either or both study drugs||Percentage of participants|||Number
100030|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
100031|NCT00814320|Secondary|Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site|"Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site.~An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion."|During infusion or within 60 minutes of completion of the infusion|Safety Analysis Data Set||Percentage of infusions||95% Confidence Interval|Median
100032|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion|"Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants|95% Confidence Interval|Median
100033|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|"Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
100034|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated AEs|"Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of infusions|Participants||Number
100035|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated AEs|"Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set||Percentage of participants|||Number
100036|NCT00814320|Secondary|Rate of Temporally Associated AEs Per Infusion|Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion (“temporally associated”)|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set (SADS)||Number of AEs per infusion|Participants|95% Confidence Interval|Median
100037|NCT00814320|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).~IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions"|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of infusions|Participants||Number
100038|NCT00814320|Secondary|Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).~An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion."|Throughout the study period (17 months)|Safety Analysis Data Set||Percentage of participants|||Number
102273|NCT00795951|Primary|Diagnostic Performance: P-tert Butylphenol Formadehyde Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100039|NCT00814320|Secondary|Rate of Days in Hospital|"Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Days per month||95% Confidence Interval|Number
100040|NCT00814320|Secondary|Rate of Acute Physician Visits|"Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Visits per month||95% Confidence Interval|Number
100041|NCT00814320|Secondary|Rate of Days on Antibiotics|"Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Days on antibiotics per month||95% Confidence Interval|Number
100042|NCT00814320|Secondary|Rate of Days Off School or Work|"Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set||Days off per month||95% Confidence Interval|Number
100043|NCT00814320|Secondary|Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
100044|NCT00814320|Secondary|H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
100045|NCT00814320|Secondary|H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||μg/mL||95% Confidence Interval|Median
100046|NCT00814320|Secondary|H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||L/kg/day||95% Confidence Interval|Median
100062|NCT00814320|Secondary|Antibody Levels to Measles|Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results||Titer||95% Confidence Interval|Median
100047|NCT00814320|Secondary|H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||μg*days/mL||95% Confidence Interval|Median
100048|NCT00814320|Secondary|H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||μg/mL||95% Confidence Interval|Median
100049|NCT00814320|Secondary|Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
100050|NCT00814320|Secondary|Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||IU/mL||95% Confidence Interval|Median
100051|NCT00814320|Secondary|Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
100052|NCT00814320|Secondary|Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||nL/IU/day||95% Confidence Interval|Median
100053|NCT00814320|Secondary|Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||IU*days/mL||95% Confidence Interval|Median
102274|NCT00795951|Primary|Diagnostic Performance: Cobalt Dichloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100054|NCT00814320|Secondary|Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||IU/mL||95% Confidence Interval|Median
100055|NCT00814320|Secondary|Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
100056|NCT00814320|Secondary|IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||Days||95% Confidence Interval|Median
100057|NCT00814320|Secondary|IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||g/L||95% Confidence Interval|Median
100058|NCT00814320|Secondary|IgG Clearance (CL) for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||mL/kg/day||95% Confidence Interval|Median
100059|NCT00814320|Secondary|IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||g*days/L||95% Confidence Interval|Median
100060|NCT00814320|Secondary|IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||g/L||95% Confidence Interval|Median
100061|NCT00814320|Secondary|Antibody Levels to Hepatitis B|Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results||mIU/mL||95% Confidence Interval|Median
100063|NCT00814320|Secondary|Antibody Levels to Haemophilus Influenzae|Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results||μg/mL||95% Confidence Interval|Median
100064|NCT00814320|Secondary|Antibody Levels to Tetanus (Clostridium Tetani Toxoid)|Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results||IU/mL||95% Confidence Interval|Median
100065|NCT00814320|Secondary|Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4)|IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit|Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements||mg/dL||95% Confidence Interval|Median
100066|NCT00814320|Secondary|Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit.|Full Analysis Data Set||g/L||95% Confidence Interval|Median
100067|NCT00814320|Secondary|Annual Rate of All Infections Per Participant|"Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint."|Throughout the study period (17 months)|Full Analysis Data Set||Estimated infections/year||95% Confidence Interval|Number
100068|NCT00814320|Secondary|Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20|"Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20.~Expressed as a percentage.~This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B):~Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies)."|PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.|Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration||Percentage||90% Confidence Interval|Number
100069|NCT00814320|Secondary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit|Participants aged 2 to < 12 years exposed to either or both study drugs with available IgG trough level measurements||Percentage||95% Confidence Interval|Number
100070|NCT00814320|Secondary|Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"||Percentage||90% Confidence Interval|Number
100071|NCT00814320|Primary|Validated Acute Serious Bacterial Infection (VASBI) Rate|"Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen.~VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only.~The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant."|Throughout the study period (17 months)|||Estimated infections/year|||Number
100072|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each group respectively.||units on a scale||Standard Deviation|Mean
100073|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100074|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
100075|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||days|||Number
100076|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
100077|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100078|NCT00814307|Secondary|Number of Hours Per Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||hours per day||Standard Deviation|Mean
100079|NCT00814307|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||hours per day||Standard Deviation|Mean
100080|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||days||Standard Deviation|Mean
100081|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||days||Standard Deviation|Mean
100082|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||events||Standard Deviation|Mean
100083|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||events||Standard Deviation|Mean
100084|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100085|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100086|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
100087|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100088|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
100089|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100090|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
102275|NCT00795951|Primary|Diagnostic Performance: Ethylenediamine Dihydrochloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100091|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
100092|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 3|FAS population. 'n'=participants evaluable at given time point for each group respectively.||participants|||Number
100093|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100094|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
100095|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100096|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
100097|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
100098|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
100099|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
100100|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Month 4, 5 and 6|Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
100138|NCT00813995|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||mg/dL||95% Confidence Interval|Least Squares Mean
100101|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.||mm||Standard Deviation|Mean
100102|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100103|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100104|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100105|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100106|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
100107|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3|FAS population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
100108|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
100109|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
100110|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
100111|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
100112|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
100113|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 2|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
100114|NCT00814307|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
100115|NCT00814307|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
100116|NCT00814307|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 3|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed)=participants evaluable for this measure.||percentage of participants|||Number
100117|NCT00814255|Secondary|Percent Change in or Time to Doubling of Serum Creatinine||Baseline and 6 months|No data were collected.|||||
100118|NCT00814255|Secondary|Percent Change in Proteinuria||Baseline and 6 months|No data were collected.|||||
100119|NCT00814255|Secondary|Number of Participants With Adverse Events||Up to 7 months|||participants|||Number
100120|NCT00814255|Secondary|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Baseline and 6 months|No data were collected.|||||
100568|NCT00811018|Primary|Percentage of Participants With Abnormal Prothrombin Time (PT)|PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
100121|NCT00814255|Primary|Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients|Number of participants with a reduction in proteinuria at 6 months by > 50% of the value at screening AND stable GFR defined as greater than 75 ml/min/1.73m2 in those with an initial value above 90 OR within 25% of baseline for remaining patients.|baseline and 6 months|One participant was assigned to the rosiglitazone arm before the drug was replaced with the galactose arm. This participant was not included in the analysis.||participants|||Number
100122|NCT00814177|Primary|Number of Patients With Prothrombin Time Results Within the Therapeutic Range After 2 Weeks|"The number of patients with follow-up INRs within the therapeutic range was compared for patients with a single dose skipped/reduced/added versus patients with no change of dose."|2 weeks|||participants|||Number
100123|NCT00814164|Secondary|A Preliminary Relationship Between Treatment Outcome and Biologic Parameters||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
100124|NCT00814164|Secondary|Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
100125|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
100126|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
100127|NCT00814164|Secondary|Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.|||||
100128|NCT00814164|Secondary|Overall Survival|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|4 years|All treated and eligible patients||months||95% Confidence Interval|Median
100129|NCT00814164|Secondary|Disease-free Survival|Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.|5 years|All treated and eligible patients who had first objective documentation of CR or CRp.||months||95% Confidence Interval|Median
100130|NCT00814164|Primary|Complete Remission (CR)|Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).|2 years|All treated and eligible patients||percentage of participant||95% Confidence Interval|Number
100131|NCT00814138|Secondary|MG Composite Change Over 12 Months|This scale is composed of components of the QMG, MG-ADL and the MMT. These components have been shown to be the most responsive in previous clinical trials. Each item in the QMG, MG-ADL and the MMT was weighed (Rasch analysis performed) and then assigned a score. Score would range from 0 (no effects from the myasthenia gravis) to a score of 50. A participant with a score of 50 wwould be in the hospital on a ventilator.|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
100132|NCT00814138|Secondary|MG-ADL 12 Month Change|The MG-ADL is an 8 item scale developed to assess myasthenia gravis symptoms. Score will range from 0 (normal - no MG symptoms) to 24 (severe MG symptoms)|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
100133|NCT00814138|Secondary|MGQOL 12 Month Change|This test is a 15 item patient-reported scale indicating how myasthenia gravis affects the quality of life. Each item is graded as how true each statement has been over the past 7 days. The scale is 0=Not at all, 1= a little bit, 2= somewhat, 3= quite a bit and 4= very much. The numbers are then added to produce a total score. The MGQOL score would range from 0 (no MG symptoms that affected their quality of life) to a score of 60 (MG symptoms affected they quality of life very much).|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
100134|NCT00814138|Secondary|Manual Muscle Testing 12 Month Change|This measurement was developed to measure the strength of muscle groups in the face, neck, arms and legs. Measurement is made by grading the amount of weakness. Participants are graded as having normal, mild (25%) weakness, moderate (50%) weakness or severe (75%) weakness and 4 = paralyzed/unable to do. Normal would receive a score of 0, mild would receive a score of 1, moderate would receive a score of 2, severe would receive a score of 3 and unable to perform would receive a score of 4. Range would be from 0 (no weakness) to 76 (complete paralysis).|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
100135|NCT00814138|Secondary|Quantitative Myasthenia Gravis (QMG) Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The scale is from 0 - 3 for each item, with 0 meaning normal and 3 is severe. Total score can range from 0 to 39.|Change from Baseline to Month 12|||units on a scale||95% Confidence Interval|Mean
100136|NCT00814138|Secondary|Average Prednisone Daily Dose (mg/Day)|Participants were asked to fill out the amount of prednisone they took every day on a paper diary.|Total length of time daily dose information was collected, i.e. 9 months.|||mg/day||95% Confidence Interval|Mean
100137|NCT00814138|Primary|Total Prednisone Dose Area Under the Curve|The primary outcome measure was the nine-month prednisone area under the dose-time curve (AUDTC, months 4-12). The AUDTC was chosen because it accounted for changes in the prednisone dose that could occur frequently during a month.|9 months|Myasthenia Gravis patients aged 18 and older that were acetylcholine antibody positive with a myasthenia gravis foundation score of Grade II, III or IV.||mg*Months||95% Confidence Interval|Number
100140|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||Percent||95% Confidence Interval|Least Squares Mean
100141|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||Percent||95% Confidence Interval|Least Squares Mean
100142|NCT00813995|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.||Percent||95% Confidence Interval|Least Squares Mean
100143|NCT00813982|Primary|Overall Vision|Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.||Units on a Scale||Standard Deviation|Mean
100144|NCT00813943|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section|||||
100145|NCT00813943|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
100146|NCT00813943|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (Version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
100147|NCT00813943|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss)|The Vz (after single dose) and Vss (after repeated doses) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||liter||Standard Deviation|Mean
100148|NCT00813943|Secondary|Plasma Clearance (CL)|The CL for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||milliliter per minute||Standard Deviation|Mean
100569|NCT00811018|Primary|Percentage of Participants With Vital Sign Results of Potential Clinical Importance|Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.|Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
100149|NCT00813943|Secondary|Mean Residence Time From Time 0 to Infinity (MRT [0-infinity])|The MRT (0-infinity) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hour||Standard Deviation|Mean
100150|NCT00813943|Secondary|Apparent Terminal Rate Constant|The apparent terminal rate constant for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||per hour||Standard Deviation|Mean
100151|NCT00813943|Secondary|Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)|The Cpre and CT for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. One participant had implausible pre-dose concentration."||ng/mL||Standard Deviation|Mean
100152|NCT00813943|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])|The AUC (0-infinity) and AUC (0-24) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hour*ng/mL||Standard Deviation|Mean
100153|NCT00813943|Secondary|Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)|The Tmax and t1/2 for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hours||Standard Deviation|Mean
100154|NCT00813943|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
100155|NCT00813943|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
100156|NCT00813943|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
100157|NCT00813917|Primary|7-day Point Prevalence All Tobacco Abstinence|7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml|12 weeks - end of treatment|||participants|||Number
100158|NCT00813904|Secondary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.|Baseline to Day 29, continuously|All participants who received treatment with rThrombin.||Participants|||Number
100159|NCT00813904|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation|An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline through Day 29, continuously|All participants who received treatment with rThrombin.||Participants|||Number
100313|NCT00812968|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lenalidomide|Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|Pharmacokinetic (PK) population: all patients who adhered to the study treatment during the course of PK assessment (Days 1 to 5 of Cycle 1) and from whom blood and urine samples were collected.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100160|NCT00813904|Primary|Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29|Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.|At baseline and Day 29|Participants who received treatment with rThrombin and had data available from both baseline and Day 29 antibody assessments.||Participants|||Number
100161|NCT00813813|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population||units on a scale||Standard Deviation|Mean
100162|NCT00813813|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population||units on a scale||Standard Deviation|Mean
100163|NCT00813813|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
100164|NCT00813813|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population||participants|||Number
100165|NCT00813813|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population||units on a scale||Standard Deviation|Mean
100166|NCT00813813|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|Safety Population||participants|||Number
100167|NCT00813800|Secondary|Young Mania Rating Scale (YMRS) at 12 Weeks|YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.|12 weeks|Intention to Treat (ITT)||Units on a Scale||Standard Deviation|Mean
100168|NCT00813800|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks|MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.|12 weeks|Intention to Treat (ITT)||Units on a Scale||Standard Deviation|Mean
100169|NCT00813800|Primary|Carbon Monoxide Breath Level at 12 Weeks|Measured by expired breath in parts per million (ppm)|12 weeks|Intention to Treat (ITT)||ppm||Standard Deviation|Mean
100170|NCT00813761|Secondary|Physiological Responses|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale)."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification.||units on a scale||Standard Deviation|Least Squares Mean
100171|NCT00813761|Secondary|Wearing Time and Comfortable Wearing Time|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Average wearing time and average comfortable wearing time."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.||hours||Standard Deviation|Least Squares Mean
100172|NCT00813761|Secondary|Intensity of Physiological Outcomes|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to Solution Induced Corneal Staining (SICS). These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5. Scores were measured for 1 min to 5 min maximum."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.||units on a scale||Standard Deviation|Least Squares Mean
100326|NCT00812877|Secondary|Pulp Vitality|No evidence of pulpal resorption or calcification or periradicular radiolucency|Up to two years|||participants|||Number
100173|NCT00813761|Primary|Tarsal Roughness|The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Participants|Standard Error|Least Squares Mean
100174|NCT00813761|Primary|Upper Tarsal Redness|Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Participants|Standard Error|Least Squares Mean
100175|NCT00813761|Primary|Lower Tarsal Redness|Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Participants|Standard Error|Least Squares Mean
100176|NCT00813761|Primary|Bulbar Redness|Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Participants|Standard Error|Least Squares Mean
100177|NCT00813761|Primary|Limbal Redness|Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Participants|Standard Error|Least Squares Mean
100178|NCT00813761|Primary|Average Corneal Fluorescein Staining Area|corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Participants|Standard Error|Least Squares Mean
100179|NCT00813761|Primary|Average Corneal Fluorescein Type Staining|staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale|Participants|Standard Error|Least Squares Mean
100180|NCT00813761|Primary|Frequency of Tearing|Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
100181|NCT00813761|Primary|Frequency of Itching|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
100182|NCT00813761|Primary|Frequency of Eye Burning/Stinging|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
100183|NCT00813761|Primary|Frequency of Daily Lens Dryness|Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
100184|NCT00813761|Primary|Frequency of Eye Discomfort|Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
100185|NCT00813761|Primary|Lens Comfort|Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||units on a scale||Standard Error|Least Squares Mean
100186|NCT00813761|Primary|Average Daily Comfortable Wear Time|Average hours per day that contact lens were worn comfortably.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||Hours||Standard Error|Least Squares Mean
100187|NCT00813761|Primary|Average Daily Wear Time|Average hours per day that contact lens were worn.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.||Hours||Standard Error|Least Squares Mean
100188|NCT00813748|Primary|Number of Participants With ATA – Skin Testing Substudy|Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.|Substudy Week 10|Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
100189|NCT00813748|Primary|Number of Participants With Positive Skin Reaction After Skin Prick Test – Skin Testing Substudy||Substudy Day 1|Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded.||participants|||Number
100190|NCT00813748|Primary|Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study|Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
100191|NCT00813748|Primary|Medications Within Two Weeks Prior to Blood Draw|Number of participants in each medication class is reported. Participants could have received more than 1 medication class.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100193|NCT00813748|Primary|Treatment Following Subsequent Unadjudicated Anaphylactic Events – Case Participants|Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
100194|NCT00813748|Primary|Number of Participants With Subsequent Unadjudicated Anaphylactic Events – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100195|NCT00813748|Primary|Treatment Following Prior Unadjudicated Anaphylactic Events – Case Participants|Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||participants|||Number
100196|NCT00813748|Primary|Number of Participants With Prior Unadjudicated Anaphylactic Events – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100197|NCT00813748|Primary|Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100198|NCT00813748|Primary|Outcome Attributed to Adjudicated Anaphylactic Event – Case Participants|Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100199|NCT00813748|Primary|Treatment Received Following Adjudicated Anaphylactic Event – Case Participants|Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100200|NCT00813748|Primary|Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred – Case Participants|Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100201|NCT00813748|Primary|Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms – Case Participants|Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100202|NCT00813748|Primary|Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms – Case Participants||Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.||minutes||Full Range|Median
100203|NCT00813748|Primary|Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events – Case Participants|Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.|Baseline (Enrollment Visit)|All enrolled participants.||participants|||Number
100204|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 60|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
100205|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 60|BAbs are all antibodies which are capable of binding to the RNF irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA.|Month 60|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||participants|||Number
100215|NCT00813709|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to Month 60|CDMS was defined by the occurrence of a second attack or relapse over 60 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||Cumulative % of participants with CDMS||95% Confidence Interval|Number
100206|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 60|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Z-score||Standard Deviation|Mean
100207|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 60|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 60 was calculated as EDSS score at Month 60 minus EDSS score at baseline.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
100208|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 60|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||percentage of participants|||Number
100209|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 60|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from ‘0-60’. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
100210|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) at Month 60|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||percentage of participants|||Number
100211|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 60|Percent Change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||percent change||Standard Deviation|Mean
100212|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Volume, and Time Constant 2 (T2) Lesion Volume at Month 60|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||mm^3||Standard Deviation|Mean
100213|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New T1 Lesions Per Participant Per Scan at Month 60|Number of CUA lesions, new T2 lesions, new Gd+ Lesions and new T1 lesions were measured by using MRI scans.|Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||lesions||Standard Deviation|Mean
100214|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 60 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||% of participants with EDSS progression|||Number
100225|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Lesions Per Participant Per Scan at Month 36|Number of CUA lesions, new T2 lesions, new Gd+ lesions and new T1 lesions were measured by using MRI scans.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||lesions||Standard Deviation|Mean
102276|NCT00795951|Primary|Diagnostic Performance: Balsam of Peru|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100216|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 36 (DB treatment period for study 28981 (REFLEXION)|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
100217|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 36|BAbs are all antibodies which are capable of binding to the investigational drug molecule (RNF) irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA (Enzyme-linked immunosorbent assay).|Month 36|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||participants|||Number
100218|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 36|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Z-score||Standard Deviation|Mean
100219|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 36 was calculated as EDSS score at Month 36 minus EDSS score at baseline.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
100220|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 36|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||Percentage of participants|||Number
100221|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 36|The Paced Auditory Serial Addition Test (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from ‘0-60’. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||units on a scale||Standard Deviation|Mean
100222|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) up to 36 Months|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Baseline (Day 1 of Study 27025) up to CDMS conversion and/or up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||percentage of participants|||Number
100223|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 36|Percent change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.||percent change||Standard Deviation|Mean
100224|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Lesion Volume and Time Constant 2 (T2) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions at Month 36|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||cubic millimeter (mm^3)||Standard Deviation|Mean
102277|NCT00795951|Primary|Diagnostic Performance: Negative Control|Number of subjects with positive reactions recorded at visit 3 or visit 4.|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100226|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 36 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||% of participants with EDSS progression|||Number
100227|NCT00813709|Primary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months|CDMS was defined by the occurrence of a second attack or relapse over 36 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).||Cumulative % of participants with CDMS||95% Confidence Interval|Number
100228|NCT00813592|Secondary|To Characterize the Safety and Tolerability of SOM230|Number of participants to experience adverse events|Monthly from study entry until subject taken off study, average 28 months|||participants|||Number
100229|NCT00813592|Secondary|To Determine the Clinical Benefit Rate (CR + PR + Stable Disease) of SOM230||November 2011||||||
100230|NCT00813592|Secondary|To Establish the Median PFS and Overall Survival (OS)||November 2011||||||
100231|NCT00813592|Secondary|To Establish the 6-month Progression-free Survival Rate||November 2011||||||
100232|NCT00813592|Secondary|To Determine the Duration of Response to SOM230||November 2011||||||
100233|NCT00813592|Primary|Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma|Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.|November 2011||||||
100234|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC)Endpoint|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|End of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
100235|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period."|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
100236|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.~The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|Two months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
100237|NCT00813488|Secondary|Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient’s overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=–3, much worse=–2, minimally worse=–1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period."|One month after start of open-label extension|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Unit on a scale||Standard Deviation|Mean
100238|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) Endpoint|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period.|At conclusion of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on a scale||Standard Deviation|Mean
100296|NCT00812968|Secondary|Percentage of Bone Marrow Myeloblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."||Percentage of myeloblasts||Full Range|Median
100239|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period.|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on scale||Standard Deviation|Mean
100240|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period.|2 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Units on scale||Standard Deviation|Mean
100241|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient’s overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= –3, much worse= –2, minimally worse= –1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period.|One month after start of open-label treatment|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.||Unit on a scale||Standard Deviation|Mean
100242|NCT00813488|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients’ preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient’s preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.|Double-blind safety analysis set: 143 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment||Participants|||Number
100243|NCT00813488|Secondary|Medication Performance Assessment 60 Minutes Post-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Episodes|Participants||Number
100244|NCT00813488|Secondary|Medication Performance Assessment 30 Minutes Post-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Episodes|Participants||Number
100245|NCT00813488|Secondary|Use of Standard Rescue Medication|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient’s diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|Throughout the double-blind treatment period|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Episodes|Participants||Number
100246|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100743|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4||Baseline, Visit 4, pre –dose (approximately 28 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
100247|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100248|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100249|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100250|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100251|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes|Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100252|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=60 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100253|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=45 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100570|NCT00811018|Primary|Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance|Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.|Weeks 28,60,72,84,96,104, Transition Visit up to 82 months|Data not summarized, study terminated early||percentage of participants|||Number
100254|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=30 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100255|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=15 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100256|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=10 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100257|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Episodes|Participants||Number
100258|NCT00813488|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Percentage change||Standard Deviation|Mean
100259|NCT00813488|Secondary|Total Pain Relief at 60 Minutes (TOTPAR60)|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||units on a scale|Participants|Standard Error|Least Squares Mean
100260|NCT00813488|Secondary|Pain Relief Score at 60 Minutes Post-treatment|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
100297|NCT00812968|Secondary|Change From Baseline in Percentage of Bone Marrow Erythroblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|Efficacy population with available bone marrow specimens.||Percentage of Bone Marrow Erythroblasts||Full Range|Median
100261|NCT00813488|Secondary|Pain Relief Score at 45 Minutes Post-treatment|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
100262|NCT00813488|Secondary|Pain Relief Score at 30 Minutes Post-treatment|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
100263|NCT00813488|Secondary|Pain Relief Score at 15 Minutes Post-treatment|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
100264|NCT00813488|Secondary|Pain Relief Score at 10 Minutes Post-treatment|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
100265|NCT00813488|Secondary|Pain Relief (PR) Score at 5 Minutes Post-treatment|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient’s diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|5 minutes after treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
100266|NCT00813488|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
100267|NCT00813488|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
100268|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
100310|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide|Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100269|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
100270|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
100271|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment|Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Baseline (immediately pre-dose) and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
100272|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period.|Immediately before treatment and 10 minutes after treatment.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
100273|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change||Standard Deviation|Mean
100274|NCT00813488|Secondary|Pain Intensity Difference (PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
100275|NCT00813488|Secondary|Pain Intensity Difference (PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
100744|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3||Baseline, Visit 3, pre –dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
100276|NCT00813488|Secondary|Pain Intensity Difference (PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
100277|NCT00813488|Secondary|Pain Intensity Difference (PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 10 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
100278|NCT00813488|Secondary|Pain Intensity Difference (PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
100279|NCT00813488|Primary|Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on scale|Participants|Standard Error|Least Squares Mean
100280|NCT00813319|Primary|Total Doses Received of HPV Vaccine|As an additional primary outcome, we assessed the total number of vaccine doses received|measured at 7-months post randomization|||Doses|||Number
100281|NCT00813319|Secondary|STD Incidence|Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction|7 months post randomization|||participants|||Number
100282|NCT00813319|Primary|GARDASIL Vaccination Uptake and Compliance With Second and Third Doses|Number of participants who received at least 1 dose, 2 doses, 3 doses|measured at 7 months post-randomization|||participants|||Number
100283|NCT00813150|Secondary|Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria|Percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) is reported in the below table. IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescencec; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.|Up to 46 days after last bortezomib dose, or as soon as possible after early discontinuation of study treatment or before start of alternative anti-myeloma therapy|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.||Percentage of participants|||Number
100284|NCT00813150|Secondary|Overall Survival (OS)|Time interval in months time from randomisation to death from any cause.|From the date of randomization until Month 49|Intent-to-treat (ITT): Participants received at least 1 dose of study medication were included in the ITT analysis set. Participants still alive at the end of the study or dropped out will be censored with the last available date.||Months||95% Confidence Interval|Median
100311|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide|Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100312|NCT00812968|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenalidomide|Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population||hours||Full Range|Median
100285|NCT00813150|Secondary|Progression-Free Survival (PFS)|PFS is defined as time from randomization to myeloma progression according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of ≥25 percent from lowest response level in Serum M-component and/or (the absolute increase must be ≥0.5 g/dL) Urine M-component and/or (the absolute increase must be ≥200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be ≥10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65mmol/L) that can be attributed solely to the plasma cell proliferative disorder. PFS included disease progression as well as death.|From the date of randomization until the disease progression or participant's death from any cause whichever occured first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): all participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication. Participants without progression and who are still alive at the end of the study or dropped out will be censored with the last available date.||Months||95% Confidence Interval|Median
100286|NCT00813150|Primary|Time to Progression of Disease|’Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|From the date of randomization until the disease progression or participant's death from any cause whichever occurred first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.||Months||95% Confidence Interval|Median
100287|NCT00813111|Secondary|Number of Participants With Adverse Events||30 days||||||
100288|NCT00813111|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|"Assessments of postoperative pain included pain intensity at rest (using the NRS at rest [NRS-R] and with activity [using the NRS-A]) where the prescribed activity was raising both arms.~Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain."|through 72 hours|Note: 136 subjects were randomized and received study drug and were included in the analyses. 10 subjects were randomized but not dosed and 4 additional subjects failed screening, resulting in 122 subjects.||Units on a scale*hours||Standard Deviation|Mean
100289|NCT00813098|Secondary|Change From Baseline at Week 4 on the Global Improvement Score.|"The IBS Global Improvement Scale (IBS-GAI) asks Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved? The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score."|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
100290|NCT00813098|Secondary|Change From Baseline at Week 4 on the Severity of Bloating|"Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being not at all and 100 mm being worst possible). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating."|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
100291|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Frequency|Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency.|Baseline to Week 4|Per protocol population; Last observation carried forward.||Number of daily stools||Standard Deviation|Mean
100292|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Consistency Scores|Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline.|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
100293|NCT00813098|Secondary|Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate|"To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,Have you felt or experienced a sense of urgency to pass stool today? The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline."|Baseline to Week 4|Per protocol population; Last observation carried forward.||Score on a scale||Standard Deviation|Mean
100294|NCT00813098|Primary|Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4|"The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"|Week 4|Per protocol population; Last observation carried forward.||Participants|||Number
100295|NCT00812968|Secondary|Percentage of Bone Marrow Promyelocytes|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."||Percentage of promyelocytes||Full Range|Median
100298|NCT00812968|Secondary|Number of Participants With a Cytogenetic Response|"Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.~A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period."|Response was assessed every 12 weeks through Week 156|Efficacy population||participants|||Number
100299|NCT00812968|Secondary|Number of Participants With a Platelet Response|"Platelet response was determined using the IWG (2000) criteria. Major response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 30,000/mm^3 increase sustained for consecutive 56 days during the treatment period. In platelet-transfusion-dependent patients at Baseline a major response is defined as stabilization of platelet counts and platelet transfusion independence sustained for consecutive 56 days during the treatment period.~Minor response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 50% increase in platelet count with an absolute increase > 10,000/mm^3 and < 30,000/mm^3 sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with a Baseline platelet count of < 100,000/mm^3 or who were platelet-transfusion dependent at Baseline. There were no patients with platelet count of < 100,000/mm3 or who were platelet-transfusion dependent at Baseline, and thus platelet response was not evaluated.|||||
100300|NCT00812968|Secondary|Number of Participants With a Neutrophil Response|"Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.~A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with Baseline neutrophil count < 1,500/mm^3.||participants|||Number
100301|NCT00812968|Secondary|Change From Baseline in Hemoglobin Concentration|Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders.|Baseline and from Day1 until the maximum observed value (up to 155 weeks)|Efficacy population with a erythroid response||g/dL||Full Range|Median
100302|NCT00812968|Secondary|Duration of Erythroid Response|Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response.|From the first dose of study drug through Week 156|Efficacy population with a erythroid response||weeks||95% Confidence Interval|Median
100303|NCT00812968|Secondary|Time to Erythroid Response|Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response.|From the first dose of study drug through Week 156|Efficacy population||weeks||Full Range|Median
100304|NCT00812968|Secondary|Number of Participants With a Erythroid Response|"Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.~A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.~Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days."|Response was assessed every 28 days through Week 156.|Efficacy population: all patients who had a diagnosis of low- or intermediate-1-risk MDS associated with anemia based on confirmation by the central reviewers and received at least 1 dose of study drug.||participants|||Number
100305|NCT00812968|Secondary|Apparent Terminal Elimination Rate Constant of Lenalidomide|Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||1/h||Geometric Coefficient of Variation|Geometric Mean
100306|NCT00812968|Secondary|Apparent Total Plasma Clearance (CL/F) of Lenalidomide|Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||mL/minute||Geometric Coefficient of Variation|Geometric Mean
100307|NCT00812968|Secondary|Apparent Volume of Distribution (VzF) of Lenalidomide|Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||liters||Geometric Coefficient of Variation|Geometric Mean
100308|NCT00812968|Secondary|Terminal Half-life (T1/2) of Lenalidomide|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data||hours||Geometric Coefficient of Variation|Geometric Mean
100309|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1.|Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100314|NCT00812968|Primary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).|Safety population: all patients who received at least 1 dose of study drug.||participants|||Number
100315|NCT00812955|Other Pre-specified|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
100316|NCT00812955|Other Pre-specified|Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Inter-Quartile Range|Median
100317|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
100318|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
100319|NCT00812955|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|"The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups:~ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set."|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
100320|NCT00812916|Secondary|Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points|Does not include 2 outliers with >300 CFAE discrete points. Based on the user-defined definition of a CFAE complex, the system identifies the number of intervals between adjacent CFAE complexes and the cycle length of these intervals. This makes it possible to estimate the number of CFAE complexes within certain amplitude and duration values. A CFAE complex is defined by the system based on the intervals between the peaks. Therefore, clinically, the CFAE software includes an algorithm that enables detection of CFAE complexes. The automatic detection and distribution of CFAE signals is taking place during a 2.5 second intra-cardiac ECG recording. When the CFAE areas are completely eliminated, but the arrhythmia continues as organized atrial flutter or atrial tachycardia, the atrial tachy-arrhythmias may be mapped and ablated upon discretion of the investigator. Analyses occur post-procedure.|Procedural|Safety population with non-outlier endpoint reported||points||Standard Deviation|Mean
100321|NCT00812916|Secondary|Total Fluoroscopy Time|Mean total fluoroscopy time|Procedural|Safety population with fluoroscopy time reported||minutes||Standard Deviation|Mean
100322|NCT00812916|Secondary|Total Radiofrequency (RF) Duration|Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.|Procedural|Safety population with RF data reported||minutes||Standard Deviation|Mean
100323|NCT00812916|Secondary|Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time|Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes|Procedural|Safety population with mapping time reported||minutes||Standard Deviation|Mean
100324|NCT00812916|Secondary|Total Ablation Time|Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported|Procedural|Safety population with ablation time reported||minutes||Standard Deviation|Mean
100325|NCT00812916|Primary|Acute Success|Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion|End of procedure|Patients with CFAE-guided RF catheter ablation||percentage achieving success||95% Confidence Interval|Number
100327|NCT00812877|Primary|Tooth Survival|No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.|Up to two years|12 subjects were excluded in the Mineral Trioxide Aggregate group due to lack of follow-up (4 subjects were non-responsive; unable to contact 6 subjects; 2 subjects changed dentists) and 6 subjects were in the Calcium Hydroxide group (2 subjects were non-responsive; unable to contact 3 subjects; 1 subject was incarcerated).||participants|||Number
100328|NCT00812812|Secondary|Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal|Summary statistics for the plasma paroxetine concentrations at each time point were calculated by the dosage just before blood sampling using data from participants in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).|Week 8 or Withdrawal (up to Week 8)|All participants who received paroxetine and in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
100329|NCT00812812|Secondary|Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8|CGI-SI is assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 1, 2, 3, 4, 6, and 8 minus the score at Baseline.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.||scores on a scale||Standard Deviation|Mean
100330|NCT00812812|Secondary|Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8|CGI-GI is assessed on an 8-grade scale: 0, not assessed; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. CGI-GI was assessed by the investigator. Participants who were rated as 1 (very much improved) or 2 (much improved) were categorized as CGI-GI responders.|Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.||participants|||Number
100331|NCT00812812|Secondary|Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Weeks 1, 2, 3, 4, and 6|FAS. The analysis was performed on the observed case (OC) dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week.||scores on a scale||Standard Error|Least Squares Mean
100332|NCT00812812|Primary|Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase, but excluding participants without the target indication, participants who received no tablet of the treatment phase medication, or participants who had no post-baseline CDRS-R data. The analysis was performed on the last observation carried forward (LOCF) dataset.||scores on a scale||Standard Error|Least Squares Mean
100333|NCT00812604|Secondary|The Mandibular Function.|The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.|4 weeks|||mm||Standard Deviation|Mean
100334|NCT00812604|Primary|The Efficacy in the Treatment of TMJ and Muscle Pain|"The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).~The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as “no pain ( 0 mm) and  worst pain possible ( 100 mm)."|4 weeks|||units on a scale||Standard Deviation|Mean
100335|NCT00812565|Secondary|Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24|Cerebral glucose metabolism was measured in validated 3 dimensional statistic surface projection analysis (Cortex ID®, GE Healthcare), transversal/coronal/sagittal-slice analysis (HERMES BRASS), and voxel-wise whole brain analysis (SPM5) using [18F]fluorodeoxyglucose positron emission tomography.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||µCi/mL||Standard Deviation|Mean
100336|NCT00812565|Secondary|Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24|The volume of the whole brain and of the left and right hippocampus was measured using high-resolution structural coronal 3D heavily T1-weighted gradient-echo sequence magnetic resonance imaging. All evaluations were done centrally by Professor Frederik Barkhof at the Image Analysis Centre, VU Medical Center, Amsterdam, Netherlands. A negative change score indicates loss of brain volume.|Screening to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||cm^3||Standard Deviation|Mean
100357|NCT00812487|Secondary|Pre-ejection Period (PEP)|Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.|24 hours|||ms||Standard Deviation|Mean
100337|NCT00812565|Secondary|Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24|A semi-structured interview was conducted by a physician, neuropsychologist, psychometrician, or certified study coordinator with the patient and a caregiver. Based on the results of the interview, the patient was rated on 6 domains of cognition and function: Memory, orientation, judgment/problem solving, community activities, home and hobbies, and personal care. Each domain is rated from 0 = no dementia; 0.5 = questionable dementia, mild cognitive impairment; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia. The total score ranges from 0 to 18 with a higher score indicating more dementia. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
100338|NCT00812565|Secondary|Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24|The ADAS-ADL consists of 23 questions that measure the ability of a person to perform basic activities of daily living, such as eating, walking, bathing, grooming, and dressing. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 78 with a lower score indicating more impaired ability. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
100339|NCT00812565|Secondary|Change From Baseline in the Alzheimer’s Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24|The ADAS cog consists of 11 items that assess cognitive areas that are often impaired in Alzheimer’s disease, specifically learning (word list), naming (objects), following commands (1 to 5 elements), ideational praxis (mail a letter), constructional praxis (copy 4 figures), orientation (person, time and place), recognition memory (from a second word list), and remembering test instructions (from the recognition subtest). The test includes 3 additional subjective scales that assess spoken language ability, word finding difficulty, and comprehension. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 70 with a higher score indicating greater cognitive impairment. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
100340|NCT00812565|Secondary|Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24|The MMSE test contains 30 questions that assess 8 cognitive domains (orientation to time, orientation to place, registration, attention and calculation, recall, language, repetition, and complex commands). The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 (severe impairment) to 30 (no impairment), with a higher score indicating a better mental status. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
100341|NCT00812565|Secondary|Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining tau and phosphorylated tau in cerebral spinal fluid were processed at a central laboratory using commercially available kits from Innogenetics NV (INNOTEST® hTau Ag, INNOTEST PHOSPHO-TAU (181P); Gent, Belgium). To measure phosphorylated tau, tau phosphorylated at threonine 181 (pTau181) was determined.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||pg/mL||Standard Deviation|Mean
100342|NCT00812565|Secondary|Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||RTU||Standard Deviation|Mean
100343|NCT00812565|Secondary|Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining Aβ1-40 and Aβ1-42 in cerebral spinal fluid were processed at a central laboratory using a commercially available kit from Meso Scale Discovery (MSD 96-Well Multi-Spot Human/Rodent (4G8) Abeta Triplex Ultra-Sensitive Assay; Rockville, MD, USA).|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||pg/mL||Standard Deviation|Mean
100358|NCT00812487|Secondary|High Frequency Heart Rate Variability|High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.|24 hours|||ms^2||Inter-Quartile Range|Median
100359|NCT00812461|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100360|NCT00812461|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100344|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||RTU*days||Standard Deviation|Mean
100345|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||(pg/mL)*days||Standard Deviation|Mean
100346|NCT00812565|Secondary|Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||RTU||Standard Deviation|Mean
100347|NCT00812565|Secondary|Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)|Samples for determining Aβ1-40 and Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||pg/mL||Standard Deviation|Mean
100348|NCT00812565|Primary|Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-40 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.||(pg/mL)*days||Standard Deviation|Mean
100349|NCT00812487|Secondary|Mean Glucose|mean sensor glucose|24 hours|||mg/dl||Standard Deviation|Mean
100350|NCT00812487|Secondary|Coefficient of Variation (CV)|CV is a measure of glycemic variability|24 hours|||percentage (mean glucose/SD)||Standard Deviation|Mean
100351|NCT00812487|Primary|Hospital Readmission|All-cause hospital readmission within 30 days|30 days|||participants|||Number
100352|NCT00812487|Primary|Hospital Length of Stay|Duration of hospitalization|participants were followed for the duration of hospital stay, median hospital stay 8 day|||days||Inter-Quartile Range|Median
100353|NCT00812487|Secondary|Glycemic Lability Index (GLI)|GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements|24 hours|||(mg/dl)^2/hr*day-1||Inter-Quartile Range|Median
100354|NCT00812487|Secondary|Quality of Life|Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).|30 days|||units on a scale||Inter-Quartile Range|Median
100355|NCT00812487|Secondary|Brain Natriuretic Peptide (BNP)|Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits|72 hours|||pg/ml||Inter-Quartile Range|Median
100356|NCT00812487|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).|72 hours|||mg/dl||Inter-Quartile Range|Median
100745|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2||Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
100362|NCT00812461|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS||units on a scale||Standard Error|Mean
100363|NCT00812461|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS||percentage of participants|||Number
100364|NCT00812461|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS||g||Standard Error|Mean
100365|NCT00812461|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.||days||Standard Error|Mean
100366|NCT00812331|Secondary|Terminal Elimination Half-life (t1/2,Term) of TMC435|The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection. The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||hours||Full Range|Median
100367|NCT00812331|Secondary|Elimination Rate Constant of TMC435|In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||1/hour||Full Range|Median
100368|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435|The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng*h/mL||Full Range|Median
100369|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435|The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - as all randomized participants who received at least 1 dose of study medication (TMC435).||ng*h/mL||Full Range|Median
100370|NCT00812331|Secondary|Fluctuation Index (FI) of TMC435|The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||% fluctuation||Full Range|Median
100371|NCT00812331|Secondary|Average Steady-State Plasma Concentration (Css,av) of TMC435|The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
100372|NCT00812331|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||hours||Full Range|Median
100373|NCT00812331|Secondary|Maximum Plasma Concentration (Cmax) of TMC435|The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
100374|NCT00812331|Secondary|Minimum Plasma Concentration (Cmin) of TMC435|The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
100375|NCT00812331|Secondary|Predose Plasma Concentration (C0h) of TMC435|The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.|Predose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||ng/mL||Full Range|Median
100435|NCT00811928|Secondary|Number of Participants With Clinical Failure During Treatment|"Clinical failure was defined as follows:~Presence of a proven or probable IFI~Systemic antifungal treatment (IV) for 4 consecutive days or more than 10 days total~Discontinuation due to adverse event (AE) possibly or probably related to study drug~Lost-to-follow-up or discontinuation from the study for any reason with loss to follow-up during the Treatment Phase"|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
100376|NCT00812331|Secondary|Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period|The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.|During the 7-day of TMC435 treatment period|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||Participants|||Number
100377|NCT00812331|Secondary|Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period|The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population - all randomized subjects who received at least 1 dose of study medication (TMC435)||Participants|||Number
100378|NCT00812331|Secondary|Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period|The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population- all randomized subjects who received at least 1 dose of study medication (TMC435)||Participants|||Number
100379|NCT00812331|Primary|Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels|The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.|Baseline, Day 3, and Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).||log10 IU/mL||Standard Error|Mean
100380|NCT00812253|Secondary|Cardiac Index||72 hours||||||
100381|NCT00812253|Secondary|Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) was measured at day 3|72 hours|||pg/ml||Inter-Quartile Range|Median
100382|NCT00812253|Secondary|Quality of Life||30 day||||||
100383|NCT00812253|Secondary|Heart Rate Variability||72 hours||||||
100384|NCT00812253|Secondary|Hospital Readmission|All-cause hospital readmission at 30 days after discharge|30 days|||participants|||Number
100385|NCT00812253|Primary|Hospital Length of Stay|Duration of hospitalization in days|Days|||days||Inter-Quartile Range|Median
100386|NCT00812110|Primary|Number of Participants Who Received Influenza Vaccine.|Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination|1 hour|||participants|||Number
100387|NCT00812110|Secondary|Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?|Number of participants who received influenza vaccine the prior year.|16 months|||participants|||Number
100388|NCT00812097|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects are included.||inches||Standard Deviation|Mean
100389|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
100390|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
100391|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
100392|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.||percentage of subjects||95% Confidence Interval|Number
100393|NCT00812006|Secondary|Treatment Satisfaction (TS)|Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.|24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and post-dose satisfaction measurement at the 24-hour time point.||Attacks|||Number
100483|NCT00811655|Secondary|Volume of Adjacent Normal Brain Parenchyma Irradiated|Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).|At time of SRS|Data for this outcome was not collected.|||||
100394|NCT00812006|Secondary|Normal Rating of Functional Disability (NRFD)|Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.||Attacks|||Number
100395|NCT00812006|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.||Attacks|||Number
100396|NCT00812006|Secondary|Sustained Pain Relief (SPR)|24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.|2 - 24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the attack must have met the FAS criteria for PR at 2 hours post-dose, and from 2-24 hours the participant either answered 24-hour headache recurrence question or didn't have PR at any time or took rescue.||Attacks|||Number
100397|NCT00812006|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.||Attacks|||Number
100398|NCT00811954|Secondary|Self-reported Adherence|Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144.|At Weeks 4, 24, 48, 96, and 144|Intention to treat: All participants with fasting self-reported adherence data were included.||percentage of prescribed medication||95% Confidence Interval|Mean
100399|NCT00811954|Secondary|Change in Waist:Height Ratio From Baseline|Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.||cm:cm||95% Confidence Interval|Mean
100400|NCT00811954|Secondary|Change in Waist Circumference From Baseline|Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.||cm||95% Confidence Interval|Mean
100401|NCT00811954|Secondary|Change in Framingham 10-year Risk of MI or Coronary Death From Baseline|"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk."|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||percent risk||95% Confidence Interval|Mean
100402|NCT00811954|Secondary|Change in Fasting Plasma Glucose Level From Baseline|Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
100403|NCT00811954|Secondary|Change in Fasting Triglycerides Level From Baseline|Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
100404|NCT00811954|Secondary|Change in Fasting HDL Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
100405|NCT00811954|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||95% Confidence Interval|Mean
100484|NCT00811655|Secondary|Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery|Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.||participants|||Number
102278|NCT00795951|Primary|Diagnostic Performance: Paraben Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100406|NCT00811954|Secondary|Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)|The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||events per 100 person-years||95% Confidence Interval|Number
100407|NCT00811954|Secondary|Incidence of Death or AIDS Defining Events (CDC Category C)|The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||events per 100 person-years||95% Confidence Interval|Number
100408|NCT00811954|Secondary|CD4+ T-cell Count Changes From Baseline|Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count|Study entry to weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||cells/mm^3||95% Confidence Interval|Mean
100409|NCT00811954|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm3)|At Weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.||cells/mm^3||95% Confidence Interval|Mean
100410|NCT00811954|Secondary|Presence of Mutations Associated With INI Resistance|The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure restricted to participants in the RAL group and random sample of participants in PI/RTV groups with successful sequencing at virologic failure.||participants|||Number
100411|NCT00811954|Secondary|Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance|The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure||participants|||Number
100412|NCT00811954|Secondary|Presence of Mutations Associated With NRTI Resistance|The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure||participants|||Number
100413|NCT00811954|Secondary|Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96|"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
100414|NCT00811954|Secondary|Cumulative Incidence of First Adverse Event by Week 96|"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up."|From study entry to week 96|As treated: Participants who had events occurring while on randomized treatment are included in this analysis: grade 2 events occurring in the after 48 weeks on study are excluded. Participants were analyzed per original assigned randomized treatment.||cumulative events per 100 persons||95% Confidence Interval|Number
100415|NCT00811954|Primary|Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96|The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative events per 100 persons||95% Confidence Interval|Number
100416|NCT00811954|Primary|Cumulative Probability of First Virologic Failure by Week 96|"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.||cumulative probability per 100 persons||95% Confidence Interval|Number
100417|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 52|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100418|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 52|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100419|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 52|FAS||units on a scale||Standard Error|Mean
100420|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 52|FAS||units on a scale||Standard Error|Mean
100421|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 13|FAS||percentage of participants|||Number
100422|NCT00811941|Secondary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 13|FAS||g||Standard Error|Mean
100423|NCT00811941|Secondary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women.|Baseline and Month 13|FAS||days||Standard Error|Mean
100424|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100425|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100426|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS||units on a scale||Standard Error|Mean
100427|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS||units on a scale||Standard Error|Mean
100428|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS||percentage of participants|||Number
100429|NCT00811941|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS||g||Standard Error|Mean
100430|NCT00811941|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the APTS who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.||days||Standard Error|Mean
100431|NCT00811941|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|All-patients-treated Set (APTS)||percentage of participants|||Number
100432|NCT00811941|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.|All-patients-treated set (APTS) – all patients in the APRS excluding those with no recorded investigational medicinal product (IMP) intake and all IMP returned||participants|||Number
100433|NCT00811928|Secondary|Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization|"Exact Causes of Death and Their Relationship to IFI Episode Were As Follows:~Unlikely related: participant completed treatment and cause of death was due to primary disease or complication~Possibly related: IFI undergoing treatment without stabilization, or with failure to have a complete remission, where cause of death might have been due to IFI, including progression or relapse of primary disease~Probably related: autopsy or clinical signs suggested that progression of IFI was the probable cause of death"|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
100434|NCT00811928|Secondary|Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization|Death from any cause.|Randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
100436|NCT00811928|Secondary|Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy|The time measured in days from randomization to the administration of the first concomitant systemic anti-fungal therapy in the entire FAS population. Not all participants who accepted systemic anti-fungal therapy may have had a IFI clinical diagnosis. IFI diagnosis criteria for antifungal therapy administration may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||Days|||Number
100437|NCT00811928|Secondary|Time From Randomization to the First Onset of Proven or Probable IFI|The time measured in days to the first occurrence of proven/probable IFI diagnosis in the entire FAS population from randomization to Day 100 of follow-up visit. Participants may not have accepted immediate antifungal treatment and later received antifungal treatment based upon further investigator review of the participant's IFI condition. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, positive blood/biopsy cultures with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||Days|||Number
100438|NCT00811928|Secondary|Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization|Number of participants who developed a proven or probable IFI from randomization date to Day 100 of follow-up visit. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
100439|NCT00811928|Primary|Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period|Number of participants developing a proven or probable IFI from randomization to the last dosage date (up to 12 weeks [84 days]) plus 7 days. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 Weeks (84 days) plus 7 days|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.||participants|||Number
100440|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100441|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100442|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100443|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100444|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100445|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100446|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100447|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)||Centimeters per second (cm/s)||Standard Deviation|Mean
100448|NCT00811798|Primary|Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Day 0 up to the telephone contact at Month 12).|||Subjects|||Number
100449|NCT00811733|Secondary|Number of Participants With the Indicated Infusion-related >=Grade 3 AE|Infusion-related AEs are the AEs that resulted from administration of study drug through infusion. AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced >=Grade 3 infusion-related AEs were assessed.||participants|||Number
100450|NCT00811733|Secondary|Number of Participants With the Indicated >=Grade 3 AEs|AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a >=Grade 3 AE were assessed.||participants|||Number
100451|NCT00811733|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Drug and Withdrawal From Study|Certain AEs led to permanent discontinuation of study drug and hence resulted in their withdrawal from the study.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an AE leading to their withdrawal from the study were assessed.||participants|||Number
100452|NCT00811733|Secondary|Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a study drug-related AE were assessed.||participants|||Number
100453|NCT00811733|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an SAE categorized as being related to study drug were assessed.||participants|||Number
100454|NCT00811733|Secondary|Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment|CD4+ and CD19+ are two key flow cytometry parameters, and total hemolytic complement (CD50) is a complement parameter. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Month 3|ITT Population: only participants with blood count data at both Baseline and Month 3 were included in the analysis.||cells per microliter (µL)||Full Range|Median
100455|NCT00811733|Secondary|Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result|All human-antihuman antibody (HAHA) samples were first tested in a screening assay to identify potential HAHA positives. Next, samples that tested positive in the screening assay were further tested in the confirmation assay to determine the specificity of the signal to ofatumumab. Confirmed positive samples were reported as positive.|From baseline up to approximately 5 years|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.||participants|||Number
100456|NCT00811733|Secondary|AUC(0-tau) and AUC(0-inf) of Ofatumumab|AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be calculated..||micrograms X hours/milliliters (µg.h/mL)||95% Confidence Interval|Geometric Mean
100485|NCT00811655|Primary|Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)|Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI’s for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).|Within 12 months after SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.||Participants|||Number
100457|NCT00811733|Secondary|Cmax and Ctrough of Ofatumumab|Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be determined.||micrograms/milliliter (µg/ml)||95% Confidence Interval|Geometric Mean
100458|NCT00811733|Secondary|Half-life of Ofatumumab|Half-life (t½) is defined as the time required for the concentration of the drug in plasma to decrease to one-half of its current value. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.||Days (d)||95% Confidence Interval|Geometric Mean
100459|NCT00811733|Secondary|Volume of Distribution at Steady State of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of the drug in the body at steady state. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.||Liters (L)||95% Confidence Interval|Geometric Mean
100460|NCT00811733|Secondary|Clearance of Ofatumumab|Clearance (CL) is defined as the volume of plasma that is cleared of drug per unit of time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|Pharmacokinetic (PK) Population: all participants from whom a PK sample was obtained and analyzed. Data were provided for the number of participants for whom the parameter could be determined.||milliliters/hour (ml/hr)||95% Confidence Interval|Geometric Mean
100461|NCT00811733|Secondary|Overall Survival|Overall survival is defined as the time from baseline until death due to any cause.|From baseline up to approximately 5 years|ITT Population. Only those participants who died during the study and during the follow-up period were assessed.|||||
100462|NCT00811733|Secondary|Time to Response for Responders|Time to response is defined as the time from baseline to the first response date.|From baseline up to approximately 5 years|ITT Population. Only participants classified as responders (CR, PR, and MR) were assessed.||days||95% Confidence Interval|Median
100463|NCT00811733|Secondary|Progression-free Survival|Time to disease progression is defined as the time from baseline to disease progression or death.|From baseline up to approximately 5 years|ITT Population. Participants who experienced disease progression or death were counted as events, and other participants were censored at the time of the last adequate assessment in the study.||days|Participants|Inter-Quartile Range|Median
100464|NCT00811733|Secondary|Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator|Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node >=1.5 centimeters on any axis. Progression for PR/MR is either a >=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM.|From baseline up to approximately 5 years|ITT Population. Only those participants classified as responders were included in the analysis. Participants who had disease progression or death were counted as events, and other participants were censored at the date of the last adequate assessment in the study.||days|Participants|Inter-Quartile Range|Median
100465|NCT00811733|Secondary|Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)|IgM is a basic antibody that is produced by B cells. It is the first antibody to appear in response to initial exposure to antigen. IgM flare is defined as an IgM level that increases by >25% from baseline (BL) and is associated with a response to treatment. Avoidance of IgM flare indicates the lack of an increase in IgM of >25% from BL.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population. Only those participants who received Cycle 1 treatment (including the Redosing Cycle) were assessed.||participants|||Number
100466|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population||participants|||Number
100467|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population||participants|||Number
100586|NCT00810771|Secondary|Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.|Outcome measure measuring knowledge of CRCS using 8-item knowledge measure (all true/false questions) developed for study, scaled and categorized into low/moderate/high knowledge, where low = low knowledge and high = high knowledge.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
100468|NCT00811733|Primary|Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population||participants|||Number
100469|NCT00811733|Primary|Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|Intent-to-Treat (ITT) Population: all participants who were considered eligible for treatment and who had been exposed to study drug irrespective of the planned course of treatment.||participants|||Number
100470|NCT00811720|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100471|NCT00811720|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS||IU/L||Geometric Coefficient of Variation|Geometric Mean
100472|NCT00811720|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS||units on a scale||Standard Error|Mean
100473|NCT00811720|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS||units on a scale||Standard Error|Mean
100474|NCT00811720|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS||percentage of participants|||Number
100475|NCT00811720|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS||g||Standard Error|Mean
100476|NCT00811720|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.||days||Standard Error|Mean
100477|NCT00811655|Secondary|Overall Survival (OS)|Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|24 months after SRS|Intent-to-treat||Months||95% Confidence Interval|Median
100478|NCT00811655|Secondary|Number of Patients Who Died Due to Neurological Causes|Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.|Within 24 months post-SRS|Intent-to-treat||participants|||Number
100479|NCT00811655|Secondary|Clinical Significance of Locally Recurrent Brain Metastases|Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.|24 months post-SRS|There are no patients for this analysis because none had a local recurrence.|||||
100480|NCT00811655|Secondary|Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.|||||
100481|NCT00811655|Secondary|Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.|||||
100482|NCT00811655|Secondary|Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site|Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.||participants|||Number
100486|NCT00811642|Primary|Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 12|Pool of participants were from the Full Analysis Set (FAS): included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Participants|||Number
100487|NCT00811642|Secondary|Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up|Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.|Follow-up week 14|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Participants|||Number
100488|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 12|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.||Participants|||Number
100489|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 8|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.||Participants|||Number
100490|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 4|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. Last Observation Carried Forward (LOCF) was used for missing data.||Participants|||Number
100491|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 8|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Participants|||Number
100492|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 4|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.||Particpants|||Number
100493|NCT00811590|Primary|The Size of Intestinal Polyps||24 months|Due to small enrollment number, analysis was not possible.|||||
100494|NCT00811577|Secondary|Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. For exploratory purposes, the specimens were blindly scored in duplicate by a dermal pathologist for the estimated number of alpha-smooth muscle actin (α-SMA) positive cells per high powered field. Values ranged from 0 to several hundred. The number of α-SMA cells was assessed for exploratory purposes; therefore, at the time of this report, it was not known whether it was better to have a low or high α-SMA score.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Cells per high-powered field||Standard Deviation|Mean
100495|NCT00811577|Secondary|Histological Evaluation of Collagen|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. The specimens were blindly scored in duplicate by a dermal pathologist for dermal collagen fiber density, maturity and orientation, where 0% was completely normal and 100% was completely abnormal.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Percent||Standard Deviation|Mean
100496|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm, or AZX100 10 mg/cm, or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate positive volume, negative volume, and total volume in millimeters cubed (mm^3) at 12 months. Positive volume included the scar volume that was calculated to be above the interpolated smooth skin surface. A smaller value was preferred. Negative volume included the volume of the scar calculated to be below the interpolated smooth skin surface. It was always a negative number; negative values (closer to zero) were more desirable. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Millimeters cubed||Standard Deviation|Mean
100497|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate scar length, width, minimum elevation, and maximum elevation in millimeters (mm) at 12 months. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface. This was always a negative number. Negative values (closer to zero) were more desirable. The maximum elevation value was the highest point of the scar above the interpolated smooth skin surface. A smaller value was preferred.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Millimeters||Standard Deviation|Mean
100498|NCT00811577|Secondary|Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography|Three trocar sites were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or saline placebo/cm at 9 days and 21 days after surgery. Twelve months after surgery, images of the trocar sites were longitudinally evaluated and rated using a standard 100 mm Visual Analog Scale (VAS) by two blinded independent dermatologists, with 0 being normal skin and 100 being the worst scar imaginable. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100 and placebo and 10 mg AZX100 for each of the two raters separately. Data from both raters was not combined.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the VAS outcome, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).||Millimeters||Standard Deviation|Mean
100499|NCT00811577|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 months|The efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including the patients receiving placebo-only). In the ITT sample for the POSAS outcomes, available sample sizes were 122 at Day 42 and 113 at Month 12 (including 4 subjects who withdrew from the study but were still followed for safety until Month 12).||Units on a scale||Standard Deviation|Mean
100500|NCT00811564|Primary|Intraocular Pressure (IOP) at Week 12|Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-treat, which included all patients who started the study (randomized).||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
100501|NCT00811473|Secondary|The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness|The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of “Much” or “Very much” improved in overall bipolar illness assessment.|Day 57|||Proportions|||Number
100502|NCT00811473|Secondary|CGI-BP-C Score at Final Assessment (Day 57)|The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from Baseline to day 57|||Scores on a scale||Standard Error|Least Squares Mean
100503|NCT00811473|Secondary|Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S|The CGI-BP-S scale rates the severity of the patient’s illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from Baseline to Day 57|||Scores on a Scale||Standard Error|Least Squares Mean
100504|NCT00811473|Secondary|The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score|The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57|||participants|||Number
100505|NCT00811473|Secondary|Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).|The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57|||participants|||Number
100506|NCT00811473|Primary|Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)|Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).|Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57|||Scores on a scale||Standard Error|Least Squares Mean
100507|NCT00811434|Secondary|Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function|MHE as measured by failure of one or more cognitive test|before and after each treatment period|data not collected as planned|||||
100508|NCT00811434|Secondary|Health Related Quality of Life (HRQOL)|HRQOL administered to parents prior to treatment|baseline|data not collected as planned|||||
100509|NCT00811434|Primary|Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis|failure of one cognitive function test indicates presence of MHE|baseline|||participant|||Number
100510|NCT00811395|Secondary|Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters per scan|||Number
100511|NCT00811395|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN;"|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
100512|NCT00811395|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as offset variable and:~Model 1 (IFN-β groups): Treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates~Model 2 (GA groups): Treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||lesions per scan||95% Confidence Interval|Number
100513|NCT00811395|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using two Mixed-effect models with repeated measures [MMRM] on cubic root transformed volume data:~Model 1 (IFN-β groups): treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors;~Model 2 (GA groups): treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors."|baseline (before randomization in PDY6045 or PDY6046) and 48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters (mL)||Standard Error|Least Squares Mean
100514|NCT00811395|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||percent probability||95% Confidence Interval|Number
100515|NCT00811395|Secondary|Overview of 12-week Sustained Disability Progression|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.~If no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
102279|NCT00795951|Primary|Diagnostic Performance: Colophony|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100516|NCT00811395|Primary|Overview of AE With Potential Risk of Occurence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly hair loss and hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
100517|NCT00811395|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as offset variable and:~Model 1 (IFN-β groups): treatment group, region of enrollment and IFN-β dose level as covariates~Model 2 (GA groups): treatment group and region of enrollment as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||relapses per year||95% Confidence Interval|Number
100518|NCT00811395|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
100519|NCT00811252|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.|Up to 8 weeks|C-SSRS Data by Columbia Classification Algorithm for Suicide Assessment (C-CASA) Category (APTS)||participants|||Number
100520|NCT00811252|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF||percentage of patients|||Number
100521|NCT00811252|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)||Week 8|FAS; LOCF||percentage of patients|||Number
100522|NCT00811252|Secondary|Change From Baseline in GDS Total Score After 8 Weeks of Treatment|The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.|Baseline and Week 8|FAS; observed cases (OC); ANCOVA||units on a scale||Standard Error|Mean
100523|NCT00811252|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
100524|NCT00811252|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
100525|NCT00811252|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
100526|NCT00811252|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
100527|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment||Baseline and Week 1|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
100528|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment||Baseline and Week 2|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
100529|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment||Baseline and Week 4|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
100530|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment||Baseline and Week 6|FAS; LOCF, ANCOVA||units on a scale||Standard Error|Mean
100531|NCT00811252|Primary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)||units on a scale||Standard Error|Mean
100532|NCT00811135|Secondary|Duration of Response (DR)|DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death. CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
100533|NCT00811135|Secondary|Number of Participants With Response|Participants who had CR or PR were considered as responders. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
100534|NCT00811135|Secondary|Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
100535|NCT00811135|Secondary|Number of Participants With Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). TTP was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
100536|NCT00811135|Secondary|Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. OS was estimated using Kaplan-Meier methods.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
100537|NCT00811135|Secondary|Number of Participants With Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
100538|NCT00811135|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||months||95% Confidence Interval|Median
100539|NCT00811135|Secondary|Number of Participants With Disease Progression or Death|Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||participants|||Number
100540|NCT00811135|Primary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population||percentage of participants||95% Confidence Interval|Number
100541|NCT00811070|Secondary|Overall Survival (OS) Rate - Part 2|OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death, censored at the participant's last contact date. Percent of participants with OS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100552|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Third-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100542|NCT00811070|Secondary|Progression-free Survival (PFS) Rate - Part 2|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to treatment discontinuation due to disease progression as assessed by the investigator. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percent of participants with PFS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100543|NCT00811070|Secondary|Time to Treatment Failure (TTF) Rate - Part 2|TTF was the interval from the date of first dose of bosutinib until the earlier date of progression or death (any cause), withdrawal from treatment owing to an AE, subject refusal, or loss to follow-up (censored at the last contact date), or further anti-tumor therapy before documented progression (whichever occurred first). TTF rate indicates the probability of no treatment failure. Percent of participants with no treatment failure were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100544|NCT00811070|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The duration of OHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort||weeks||95% Confidence Interval|Median
100545|NCT00811070|Secondary|Time to Achieve Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The time to OHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort||weeks||95% Confidence Interval|Median
100546|NCT00811070|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) Up to Week 192 in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|OHR included CHR, no evidence of leukemia (NEL), minor hematologic response (MiHR) or return to chronic phase (RCP), participants had to meet at least 1 of this criterion. Criteria for RCP: disappearance of features defining AP/BP, but still in CP and persistence of clonal evolution. Criteria for MiHR: <15% blasts in blood and bone marrow, <30% blasts+promyelocytes in blood and bone marrow, <20% basophils in blood, no extramedullary disease other than liver/spleen. Criteria for CHR and NEL: <20% basophils in blood, no extramedullary involvement including liver/spleen, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, <5% (NEL) and <=5% (CHR) marrow blasts, 0.5*10^9 <= Absolute neutrophil count (ANC) <1.0*10^9/L (NEL) and ANC>=1.0*10^9/L (CHR), 20*10^9 <=platelets<100 *10^9/L (NEL) and platelets>=100 but <450x10^9/L (CHR), white blood cells <=institutional upper limit of the normal range.|Baseline up to Week 192|Subset of the third-line cohort who was in accelerated or blast phase||percentage of participants|||Number
100547|NCT00811070|Secondary|Duration of Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population||weeks||95% Confidence Interval|Median
100548|NCT00811070|Secondary|Time to Achieve Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population.||weeks||95% Confidence Interval|Median
100549|NCT00811070|Secondary|Percentage of Participants With Complete Hematologic Response (CHR) up to Week 192 in Advance Phase Second-line Cohort - Part 2|CHR response was considered to be achieved if participants met all of the following criteria: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >=1.0*10^9 per liter (/L), platelets >=100 but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.|Baseline up to Week 192|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100550|NCT00811070|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|Duration of MCyR was defined as the interval from the date of the earliest demonstration of a response, until the earliest date of loss of that response. Duration of response in weeks = (date of confirmed loss of first attained response minus date of first attained response)/7 days.|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population||weeks||95% Confidence Interval|Median
100551|NCT00811070|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|"Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.~Time to response in weeks = (event date minus first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last cytogenetic assessment date of a participants."|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population||weeks||95% Confidence Interval|Median
100566|NCT00811057|Primary|The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.|Gestational age at delivery in weeks.|3-5 days after delivery|||weeks||Standard Deviation|Mean
100553|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100554|NCT00811070|Secondary|Percentage of Participants With Maintained Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line and Third-line Cohort - Part 2|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.~The responder for maintained MCyR included 'participants without baseline response who had a response at a specified time' and 'participants with baseline response who had a post-baseline response either maintained or improved at a specified time'."|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100555|NCT00811070|Primary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.||percentage of participants||95% Confidence Interval|Number
100556|NCT00811070|Secondary|Accumulation Ratio (R) - Part 1|R=accumulation ratio (AUCss on Day 15/AUC[0-24] on Day 1)|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.||ratio||Standard Deviation|Mean
100557|NCT00811070|Secondary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.||liter||Standard Deviation|Mean
100558|NCT00811070|Secondary|Apparent Oral Clearance (CL/F) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F on Day 15 was assessed as the steady state CL/F.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."||L/hr||Standard Deviation|Mean
100559|NCT00811070|Secondary|Area Under the Concentration-Time Curve (AUC) - Part 1|Area under the plasma concentration time-curve from zero to infinity. AUC on Day 15 was assessed as the steady state AUC.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."||nanogram*hour per milliliter (ng•hr/mL)||Standard Deviation|Mean
100560|NCT00811070|Secondary|Plasma Decay Half-Life (t1/2) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.||hour||Standard Deviation|Mean
100561|NCT00811070|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."||hour||Full Range|Median
100562|NCT00811070|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
100563|NCT00811070|Primary|Maximum Tolerated Dose (MTD) - Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.||mg|||Number
100564|NCT00811070|Primary|Number of Participants With Dose-Limiting Toxicity (DLT) - Part 1|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.||Participants|||Number
100565|NCT00811057|Secondary|The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery|Days gained after treatment to delivery|after delivery of the infant|||days||Standard Deviation|Mean
100571|NCT00811018|Primary|Percentage of Participants With Elevated International Normalize Ratio (INR)|Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population||percentage of participants|||Number
100572|NCT00811018|Primary|Percentage of Participants With Anticoagulant Use|Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population||percentage of participants|||Number
100573|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)|Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab||percentage of participants|||Number
100574|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Chemistry)|Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab||percentage of participants|||Number
100575|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Hematology)|Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab||percentage of participants|||Number
100576|NCT00811018|Primary|Percentage of Participants With Total Bilirubin > 1.5 x ULN|Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population||percentage of participants|||Number
100577|NCT00811018|Primary|The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population||percentage of participants|||Number
100578|NCT00811018|Primary|The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population||percentage of participants|||Number
100579|NCT00811018|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Day 1 up to 82 months|Safety Population: all enrolled participants who took at least one dose of sitaxsentan 100 mg during the study||participants|||Number
100580|NCT00810901|Secondary|Talked to Parents About Choice to be Organ Donor on License at 12 Months|Number of teens who talk had not talked to parents at baseline but reported they had talked to their parents about the choice to become an organ donor on their driver's license at 12 months|12 months|||participants||95% Confidence Interval|Number
100581|NCT00810901|Primary|Designated Organ Donor Status on Driver's License|Number of students who reported not being donor at baseline but were donor at 12 months follow-up|12 months|t-test||participants||95% Confidence Interval|Number
100582|NCT00810771|Secondary|If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.|"Outcome measure measuring percentage of participants discussing CRCS with provider using single question (yes/no): did you discuss Colorectal Cancer Screening with your provider?"|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
100583|NCT00810771|Secondary|Self Efficacy.|Outcome measure measuring self-efficacy using 5-item measure, dichotomized into low vs. high self-efficacy (confidence) in getting screened.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
100584|NCT00810771|Secondary|Intent to Get Colorectal Cancer Screening.|Outcome measure measuring intent to get CRC screening using 5-item stage of readiness scale. Intent is measured by looking at the highest 2 items (I think I will get screened and I am committed to getting screened).|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||percentage of participants|||Number
100585|NCT00810771|Secondary|Decisional Satisfaction|"Outcome measures measuring decisional satisfaction using 7-item scale categorized into low, moderate, high.~Decisional satisfaction is a measure that was first developed by Margaret Holmes Rover and colleagues (Med Decis Making. 1996 Jan-Mar;16(1):58-64) to assess the perspective of a patient involved in a medical decision with the decision making process. The measure includes questions related to overall satisfaction, and satisfaction with the amount of information received, involvement in, degree of consistency with values, and time to make the decision. The measure includes 5 questions each on a 5 point scale where higher scores = higher satisfaction. When scaled into one overall measure of decision satisfaction, lower scores = lower satisfaction and higher scores = higher satisfaction."|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.||Percentage of participants|||Number
102280|NCT00795951|Primary|Diagnostic Performance: Fragrance Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100587|NCT00810771|Secondary|Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider|Outcome measure using 6 items measuring degree of participation in IDM. Scaled and recategorized into Low, Moderate and High level of IDM. The range is from 1 (low level of IDM) to 6 (high level of IDM).|3-5 days after Decider Guider intervention|Data was not collected for Usual Care arm.||Degree of participation||Full Range|Mean
100588|NCT00810771|Primary|Colorectal Cancer (CRC) Screening Rate.|The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.|Within 6 months of Decider Guider intervention.|||percentage of participants|||Number
100589|NCT00810693|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.||Scores on a scale||Standard Deviation|Mean
100590|NCT00810693|Secondary|EQ-5D Utility Score - Change From Baseline to Week 12|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.||Scores on a scale||Standard Deviation|Mean
100591|NCT00810693|Secondary|Borg CR 10 Scale - Change From Baseline to Week 12|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Scores on a scale||Standard Deviation|Mean
100592|NCT00810693|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .|At week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Percentage of participants|||Number
100593|NCT00810693|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 12|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.||Percentage of participants|||Number
100594|NCT00810693|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.||pg/mL||Standard Deviation|Mean
100595|NCT00810693|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.||dyn*s*cm^-5||Standard Deviation|Mean
100596|NCT00810693|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.||Meters||Standard Deviation|Mean
100597|NCT00810641|Primary|Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial|The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.|one hour|Of the 157 patients enrolled in the study, three were lost for follow-up (dropout rate, 1.9%) and 154 were finally included for analyses.||participants||95% Confidence Interval|Number
100598|NCT00810602|Secondary|Percent Survival at 2-years|To determine 2-year overall survival rate|two years|evaluable subjects||percentage of subjects|||Number
100599|NCT00810602|Secondary|Percent Cumulative Incidence of Relapse at 2 Years.|Determine the cumulative incidence of relapse at 2 years.|two years|evaluable subjects||percentage of participants|||Number
100600|NCT00810602|Secondary|Number of Serious Adverse Events|The safety and feasibility will be partially measured by the number of serious adverse events (SAE) recorded by participants receiving at least one dose of Vorinostat.|100 days|The number of patients who received at least one dose of vorinostat.||Number of Serious Adverse Events|||Number
100601|NCT00810602|Primary|100-day Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)|Assess if the addition of Vorinostat to standard GVHD prophylaxis regimen can reduce the rate of grades 2-4 acute GVHD when compared to 48% in a cohort of identically treated RIC HSCT patients without vorinostat. A reduction of incidence to less than 25% will be considered successful.|100 days|evaluable||percentage of participants|||Number
100602|NCT00810576|Primary|Number of Patients With Response|Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.|Every two 21-day cycles|No analysis done due to early termination resulting from low accrual.||participants|||Number
100603|NCT00810511|Primary|Comfort at End of Day|Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 4 weeks of wear|One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation.||Scale of 1-10||Standard Deviation|Mean
100604|NCT00810368|Primary|Incremental Change in SF36 General Health Between Baseline and Week 12|Incremental change in SF36 General Health score from baseline to week 12. The SF36 General Health score ranges from 0 (very bad General Health) to 100 (very good General Health). The incremental change was the SF36 General Health score at week 12 minus the SF36 General Health score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for SF36 General Health score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the SF36 General Health score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
100605|NCT00810368|Primary|Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12|Each item on the Generalized Anxiety Scale (GAD) scores was scored as none (0), trivial (1), mild (2), moderate (3), or severe (4) and the sum of the 7 items calculated (range 0 to 28). The incremental change between Week 0 and Week 12 was determined for each treatment.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
100606|NCT00810368|Primary|SF36 Bodily Pain|Incremental change in Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score from baseline to week 12. The Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score ranges from 0 (very bad bodily pain) to 100 (no bodily pain). The incremental change was the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at week 12 minus the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
100607|NCT00810368|Primary|Incremental Change in Fatigue Score From Baseline to Week 12|Instantaneous Fatigue was scored as none (0) to severe (10) at week 0 and week 12. The difference between the Week 12 minus the Week 0 values was the incremental change. If the incremental change was greater than 0, then the Instantaneous Fatigue was worse at week 12 than week 0. If the incremental change was less than 0, then the Instantaneous Fatigue was improved at week 12 compared to week 0. The total potential range for incremental change was from -10 to +10.|Week 0 and Week 12|Number of participants with evaluable data who completed the study||units on a scale||95% Confidence Interval|Mean
100608|NCT00810368|Secondary|Digit Symbol Substitution (WAIS)|Digit Symbol Substitution (WAIS) test (Joy et al., 2000): Subjects were given a table of numerals with matching symbols, and a form with random numerals with open spaces. The objective was to write in as many symbols that corresponded to the random numerals within a 90 second period. Each subject was their own control. The outcome measure was the incremental change in this score between Week 0 and Week 12 (units on a scale). Higher scores indicate better performance.|Difference between Week 0 and Week 12 (end of study)|2 carnosine subjects had incomplete data.||units on a scale||95% Confidence Interval|Mean
100609|NCT00810368|Primary|Subjects With Improved Diarrhea Symptoms|Patients were given questionnaires assessing common symptom complaints of diarrhea.|Weeks 0 and 12|Participants with evaluable data at the end of the study.||participants|||Number
100610|NCT00810368|Primary|Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores|"CFS Severity Score (Δ ≥ 5 / 36) (Baraniuk et al., 1998; Baraniuk et al., 2000a; Baraniuk, Naranch, Maibach, & Clauw, 2000b). Subjects scored the severity of the 9 CFS criteria (Fatigue, memory/concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbances, exertional exhaustion from Fukuda et al. 1994) on a scale of none (score=0), trivial (1), mild (2), moderate (3) and severe (4). The sum was 36.~Individuals taking carnosine were predicted to show a decrease of ≥ 5 at week 12 compared to week 0, compared to no change for placebo subjects. 2-tailed paired t-tests were used to determine significant incremental changes for individuals in the carnosine group compared to the placebo group."|Weeks 0 and 12|Significant numbers of subjects dropped out of both arms of the study. The primary reason given was perceived lack of efficacy.||units on a scale||95% Confidence Interval|Mean
100611|NCT00810355|Primary|Symptoms|Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms.|6 months|||scores on a scale||Standard Deviation|Mean
100612|NCT00810355|Primary|Work Quantity|Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.|6 months|||hours worked per week||Standard Deviation|Mean
100613|NCT00810355|Primary|Work Quality|Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance.|6 months|||scores on a scale||Standard Deviation|Mean
100746|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4||Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
100614|NCT00810342|Secondary|Accelerometer Collected Moderate to Vigorous Physical Activity|Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months|12-Months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii||minutes per week moderate-to-vigorous PA||95% Confidence Interval|Mean
100615|NCT00810342|Primary|Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months|Self reported minutes of moderate or vigorous physical activity per week after 12-months|12 months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii||minutes per week moderate-to-vigorous PA||Inter-Quartile Range|Mean
100616|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30|||ng/ml||Standard Deviation|Mean
100617|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16|||ng/ml||Standard Deviation|Mean
100618|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15|||ng/ml||Standard Deviation|Mean
100619|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30|||ng*h/ml||Standard Deviation|Mean
100620|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16|||ng*h/ml||Standard Deviation|Mean
100621|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15|||ng*h/ml||Standard Deviation|Mean
100622|NCT00810303|Primary|Cmax of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30|||ng/ml||Standard Deviation|Mean
100623|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20|||ng/ml||Standard Deviation|Mean
100624|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5|||ng/ml||Standard Deviation|Mean
100625|NCT00810303|Primary|AUC0-24h of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30|||ng*h/ml||Standard Deviation|Mean
100626|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20|||ng*h/ml||Standard Deviation|Mean
100660|NCT00810199|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm/hr||Standard Deviation|Mean
100627|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5|||ng*h/ml||Standard Deviation|Mean
100628|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30|||ng/ml||Standard Deviation|Mean
100629|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16|||ng/ml||Standard Deviation|Mean
100630|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15|||ng/ml||Standard Deviation|Mean
100631|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30|||ng*h/ml||Standard Deviation|Mean
100632|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16|||ng*h/ml||Standard Deviation|Mean
100633|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15|||ng*h/ml||Standard Deviation|Mean
100634|NCT00810277|Secondary|Neutrophil Count||Baseline, Weeks 4, 8, and 12|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||E^9 per liter||Standard Deviation|Mean
100635|NCT00810277|Secondary|Percentage of Participants With Lipid Level Elevations|Low density lipoprotein (LDL) level was categorized as 'Optimal (less than [<] 100 milligram per deciliter [mg/dL])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as ‘Acceptable (40-59 mg/dL)’, ‘High (>=60 mg/dL)’. Total cholesterol (TC) level was categorized as ‘Desirable (<200 mg/dL)’, ‘Borderline High (200-239 mg/dL)’, ‘High (>=240 mg/dL)’.|Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
100636|NCT00810277|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal|Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum.|Up to Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
100637|NCT00810277|Secondary|Percentage of Participants Who Discontinued the Study||Up to Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
100638|NCT00810277|Secondary|Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||millimeter per hour (mm/h)||Standard Deviation|Mean
100639|NCT00810277|Secondary|C-Reactive Protein (CRP) Level||Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||milligram per liter (mg/L)||Standard Deviation|Mean
100640|NCT00810277|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response|ACR20, ACR50, and ACR70 response: greater than or equal to (>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do).|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||percentage of participants|||Number
100747|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3||Baseline, Visit 3, pre–dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
100641|NCT00810277|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||percentage of participants|||Number
100642|NCT00810277|Secondary|Disease Activity Score (DAS28)|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.||units on a scale||Standard Deviation|Mean
100643|NCT00810277|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Baseline up to Week 24|Analysis population included all participants who entered the study.||percentage of participants|||Number
100644|NCT00810199|Secondary|Time to Restart of Treatment After Discontinuation/Remission|The time in days from treatment discontinuation or remission to the restart of treatment.|104 Weeks|Participants from the intent-to-treat population, all participants who received study drug, with data available for analysis. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response had not been observed.||Days||95% Confidence Interval|Median
100645|NCT00810199|Secondary|Time to Flare After Tocilizumab Remission|The time in days to a flare (recurrence of disease symptoms) after the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.||Days||Full Range|Median
100646|NCT00810199|Secondary|Time to Drug-Free Remission|The time in days from initial study drug treatment to drug free remission that occurred when the participant was able to discontinue tocilizumab, methotrexate/placebo and open label disease-modifying antirheumatic drugs (DMARDS).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.||Days||Full Range|Median
100647|NCT00810199|Secondary|Time to Tocilizumab Remission|The time in days from initial study drug treatment to tocilizumab remission that occurred when the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.||Days||Full Range|Median
100648|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 52 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].Area under the curve for ACR response to Week 52 averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (<=5.5 and >5.5) as fixed factors.|Baseline to Week 52|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.||Score on a scale*day||Standard Error|Least Squares Mean
100649|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 24 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. Area under the curve for ACR response to Week 24 was averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (≤ 5.5 and > 5.5) as fixed factors.|Baseline to Week 24|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.||Score on a scale*day||Standard Error|Least Squares Mean
100650|NCT00810199|Secondary|Change From Baseline in Academic Medical Center (AMC) Linear Disability Scale (ALDS)|The Academic Medical Center (AMC) Linear Disability Score (ALDS) evaluates the participant’s ability to perform activities of daily life consisting of 77 questions answered yes or no . The question difficulty and the patient’s ability are arranged on a single hierarchical linear scale. ALDS scores range from 10 to 90 with a higher score representing higher functional status. A positive change from Baseline indicated improvement.|Baseline, Weeks 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis.||Score on a scale||Standard Deviation|Mean
100651|NCT00810199|Secondary|Change From Baseline in Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)|The RAQoL is a disease specific patient-reported outcome measure that determines the effect rheumatoid arthritis has on a patient’s quality of life consisting of 30 questions that are answered either yes=1 or no=0 for a total possible score ranging from 0 (best) to 30 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52, 104|Participants from the intent-to-treat Population, all participants who received study drug, with data available for analysis at the given time-point. The RAQoL score was administered in a subset of sites for which the questionnaire was available in the local language.||Score on a scale||Standard Deviation|Mean
100652|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Safety Reasons|Safety reasons were defined as adverse events, intercurrent illness or death. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100653|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Lack of Sufficient Therapeutic Response|Lack of Sufficient Therapeutic Response was defined as the patient not responding to the drug as expected.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100654|NCT00810199|Secondary|Percentage of Participants Discontinuing Tocilizumab Due to Remission|The percentage of participants who stopped treatment with tocilizumab due to remission.|Weeks 52, 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with non-missing DAS28 assessment.||Percentage of participants|||Number
100655|NCT00810199|Secondary|Change From Baseline in Erosion Score|A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. The maximum erosion score in the hands was 98 and in the feet 42 for a total possible score of 0 to 140. A lower number change from Baseline indicated a better score.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.||Score on a scale||Standard Error|Least Squares Mean
100656|NCT00810199|Secondary|Change From Baseline in Joint Space Narrowing Score|A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum scores for joint space narrowing (JSN) in the hands was 104 and in the feet 48 for a total possible score of 0 to 152. A lower change from Baseline indicated a better score. Analysis of covariance model included baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.||Score on a scale||Standard Error|Least Squares Mean
100657|NCT00810199|Secondary|Change From Baseline in Total Genant Modified Sharp Scores (GSS)|Radiographs were taken of each hand and foot at Baseline, Weeks 24, 52 and104 and were evaluated using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 98 and in the feet 42. The maximum scores for joint space narrowing (JSN) in the hands was104 and in the feet 48. The total score was the sum of scores for erosions and JSN. The maximum total modified GSS was 292. A lower number change from Baseline was better. Analysis of covariance model, with Baseline DAS28 as a covariate and treatment and site as fixed factors.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.||Score on a scale||Standard Error|Least Squares Mean
100658|NCT00810199|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at the given time-point.||Score on a scale||Standard Deviation|Mean
100659|NCT00810199|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with data available for analysis at the given time-point.||mg/dL||Standard Deviation|Mean
100969|NCT00808236|Post-Hoc|Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse|ROSC, Survival, and neurologically-intact survival|Hospital discharge|Subset of patients receiving EMS CPR within 10 minutes of collapse (representing 75% of all patients)||participants|||Number
100661|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Pain (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm||Standard Deviation|Mean
100662|NCT00810199|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm||Standard Deviation|Mean
100663|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||mm||Standard Deviation|Mean
100664|NCT00810199|Secondary|Change From Baseline in Tender Joint Count|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Joint count||Standard Deviation|Mean
100665|NCT00810199|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Joint count||Standard Deviation|Mean
100666|NCT00810199|Secondary|Percentage of Participants With Good or Moderate European League (EULAR) DAS28 Responses|"The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2.~EULAR Moderate response: DAS28 > 3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100667|NCT00810199|Secondary|Change From Baseline in DAS28 Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Score on a scale||Standard Deviation|Mean
100668|NCT00810199|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2.|Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100669|NCT00810199|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 52|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100670|NCT00810199|Secondary|Area Under Curve (AUC) DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. AUC DAS28 was averaged over study days. Analysis of Covariance was adjusted for Baseline DAS28 as a covariate and treatment group and region as fixed factors. Higher calculated AUC values are worse (indicate higher disease activity).|Baseline to Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available at Baseline and Week 24.||Score on a scale*week||Standard Error|Least Squares Mean
100688|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Visits||Standard Deviation|Mean
100671|NCT00810199|Secondary|Time to First ACR90 Response|Time in days from first administration of study drug until ACR90 response. ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
100672|NCT00810199|Secondary|Time to First ACR70 Response|Time in days from first administration of study drug until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
100673|NCT00810199|Secondary|Time to First ACR50 Response|Time in days from first administration of study drug until ACR50 response. ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate).|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
100674|NCT00810199|Secondary|Time to First ACR20 Response|Time in days from first administration of study drug until ACR20 response. ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.||Days||95% Confidence Interval|Median
100675|NCT00810199|Secondary|Percentage of Participants With ACR90 Response|ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100689|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Visits||Standard Deviation|Mean
100748|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2|Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort|Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
100676|NCT00810199|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100677|NCT00810199|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100678|NCT00810199|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100679|NCT00810199|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 24|Intent-to-treat population included all randomized participants who received study drug.||Percentage of participants|||Number
100680|NCT00810108|Primary|Lopinavir Area Under the Curve (AUC)|Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)|pre-dose, 1,2,4,6,8, and 12 hours post-dose|All subjects who completed the pharmacokinetic sampling visits with whole tablet administration were analyzed||mg*hr/L||Inter-Quartile Range|Median
100681|NCT00810095|Secondary|Number of Device-related Serious Adverse Events|Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.|Treatment to 90 days postprocedure|Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers.||events|||Number
100682|NCT00810095|Primary|Clinical Success|Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.|90 days postprocedure|Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.||percentage of participants|||Number
100683|NCT00810095|Primary|Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.|"TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:~TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram.||percentage of participants|||Number
100684|NCT00810095|Primary|Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.|"TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:~TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|All participants treated with the Test System||percentage of participants|||Number
100685|NCT00810082|Primary|Participants With at Least One Fall|Subjects who had at least one fall subsequent to treatment.|3 months|||participants|||Number
100686|NCT00810069|Secondary|Number of Participants With Adverse Events (AEs)|The list of AEs is located in the Reported Adverse Event module.|Baseline through Week 16|Full Analysis Population||participants|||Number
100687|NCT00810069|Secondary|Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response||Week 4, Week 8, Week 12, Week 16|Full Analysis Population||participants|||Number
100690|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks|Only those participants who missed at least 1 hour of work due to depression were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Hours||Standard Deviation|Mean
100691|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks|Only those participants who missed at least 1 hour of work were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Hours||Standard Deviation|Mean
100692|NCT00810069|Secondary|Resource Utilisation - Number of Hours Worked Per Week||Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.||Hours||Standard Deviation|Mean
100693|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission|Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population||estimated probability (percent)||95% Confidence Interval|Mean
100694|NCT00810069|Primary|Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population||weeks||95% Confidence Interval|Median
100695|NCT00810069|Secondary|Sheehan Disability Scale (SDS) Normal Functioning Total Score|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
100696|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score|The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
100697|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score|The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
100698|NCT00810069|Secondary|Visual Analog Scale (VAS) - Overall Pain Severity|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
100699|NCT00810069|Secondary|Clinical Global Impressions of Severity (CGI-S) Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population||units on a scale||Standard Deviation|Mean
100700|NCT00810069|Secondary|Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population||weeks||95% Confidence Interval|Median
100701|NCT00810069|Secondary|Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population||weeks||95% Confidence Interval|Median
100725|NCT00809926|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.||mm Hg||Standard Deviation|Mean
100702|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response|Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population||estimated probability (percent)||95% Confidence Interval|Mean
100703|NCT00810069|Primary|Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Set||weeks||95% Confidence Interval|Median
100704|NCT00810043|Secondary|Change in Ambulatory Status|Ambulatory status was assessed by subjective patient questionnaire.|Baseline and 48 hrs post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||participants|||Number
100705|NCT00810043|Secondary|Change in Back Pain.|Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||units on a scale||Standard Deviation|Mean
100706|NCT00810043|Secondary|Deformity Correction Assessed by Local Cobb Angle (LCA)|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||degree||Standard Deviation|Mean
100707|NCT00810043|Secondary|Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||degree||Standard Deviation|Mean
100708|NCT00810043|Secondary|Amount of Vertebra Body Height (VBH) Gained by Postural Reduction||baseline and intra-operative|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||mm||Standard Deviation|Mean
100709|NCT00810043|Secondary|Amount of Vertebral Body Height (VBH) Gained From IBTs Alone|Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.|Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||mm||Standard Deviation|Mean
100710|NCT00810043|Secondary|Index Vertebral Body Height Restored in Millimeters.|Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.|Baseline and 48 hours after procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.||mm||Standard Deviation|Median
100711|NCT00810043|Primary|Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)||Baseline and 48-hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment||percent change||Standard Deviation|Mean
100712|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
100713|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
100742|NCT00809757|Secondary|Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Baseline, Visit 3 (the week prior to Visit 3) and Visit 4|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||liters||Standard Deviation|Mean
100714|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
100715|NCT00809965|Secondary|The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
100716|NCT00809965|Primary|The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.||Percentage of patients|||Number
100717|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)|To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the ABPM substudy and who met the study inclusion and exclusion criteria for randomization.||mm Hg||Standard Deviation|Mean
100718|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).|To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the Ambulatory Blood Pressure Monitoring (ABPM) substudy and who met the study inclusion and exclusion criteria for randomization.||mm Hg||Standard Deviation|Mean
100719|NCT00809926|Other Pre-specified|Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8|To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)|Baseline through week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||mm Hg||Standard Error|Least Squares Mean
100720|NCT00809926|Other Pre-specified|Completers Analysis for Change From Baseline in MSSBP at Week 8|To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population – patients who completed the double-blind treatment period.|Baseline to week 8|The analysis included ITT patients who completed the double-blind treatment period [those patients with a final observation at week 8, also known as observed cases (OC)]. This analysis differed from the ITT-LOCF analysis, in that it did not include patients who discontinued from the trial prematurely.||mm Hg||Standard Deviation|Mean
100721|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8|To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||ng/L||Standard Deviation|Mean
100722|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8|To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||ng/mL/h||Standard Deviation|Mean
100723|NCT00809926|Secondary|Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8|To compare the percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||percentage of responders|||Number
100724|NCT00809926|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8|To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.||percentage of patients|||Number
100726|NCT00809926|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.||mm Hg||Standard Deviation|Mean
100727|NCT00809848|Secondary|Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.|Baseline, Day 14|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation||Percentage of Patients|||Number
100728|NCT00809848|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
100729|NCT00809809|Secondary|Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.||14 days||||||
100730|NCT00809809|Primary|Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.|Zinc gluconate swabs were compared as a treatment of recurrent HSL compared to placebo from the date and time of the initiation of therapy until the date and time of resolution of the lesion or after 14 days of treatment, whichever comes first.|14 days|5 subjects met exclusion criteria and were excluded from analysis. 2 subjects used concomitant medications and were excluded from the final analysis. Twelve subjects with recurrent HSL enrolled twice, only the 1st enrollment was included in the analysis. 2 subjects had family enroll who were excluded from analysis. Analysis - 134 subjects.||Days to resolution||95% Confidence Interval|Median
100731|NCT00809757|Secondary|Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLA) Composite Score|The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.|Visit 3 and Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Units on a scale||Standard Deviation|Mean
100732|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used||Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – subjects who used rescue medication at any time during the first 2 weeks of the study and who had used rescue medication at any time during baseline||Doses per Week||Standard Deviation|Mean
100733|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population||Doses per Week||Standard Deviation|Mean
100734|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Days Used Per Week When Used||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – Subjects who used rescue medication at any time during the first two weeks of the study and who used rescue medication at any time during baseline||Days per Week||Standard Deviation|Mean
100735|NCT00809757|Secondary|Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period|Number of subjects using rescue medication during the treatment period|Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population||Number of subjects|||Number
100736|NCT00809757|Secondary|Caregiver Global Assessment – Question 3|Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
100737|NCT00809757|Secondary|Caregiver Global Assessment – Question 2|Since the start of the study, how would you evaluate your ability to manage your child’s asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
100738|NCT00809757|Secondary|Caregiver Global Assessment – Question 1|Since the start of the study, how would you evaluate your child’s asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
100739|NCT00809757|Secondary|Investigator Global Assessment – Question 2|Since the start of the study, how would you evaluate your ability to manage the subject’s asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
100740|NCT00809757|Secondary|Investigator Global Assessment – Question 1|Since the start of the study, how would you evaluate the child’s asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population||Number of subjects|||Number
100741|NCT00809757|Secondary|Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)||percent change||Standard Deviation|Mean
102281|NCT00795951|Primary|Diagnostic Performance: Caine Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100749|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
100750|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
100751|NCT00809757|Secondary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
100752|NCT00809757|Secondary|Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
100753|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
100754|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
100755|NCT00809757|Secondary|Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population||units on a scale||Standard Deviation|Mean
100756|NCT00809757|Primary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis||units on a scale||Standard Deviation|Mean
100757|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||Liters||Standard Deviation|Mean
100758|NCT00809614|Secondary|PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||day*ug/mL||Standard Deviation|Mean
100778|NCT00809458|Secondary|Determine Concordance of the Biomarkers in This Setting|The correlation between the ATQ level and the androgen receptor will be explored.|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.|||||
100759|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||ug/mL||Standard Deviation|Mean
100760|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||day||Standard Deviation|Mean
100761|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||Liters/day||Standard Deviation|Mean
100762|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic ( PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set||Day||Full Range|Median
100763|NCT00809614|Secondary|Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment|The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.|Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Units on a scale||Standard Deviation|Mean
100764|NCT00809614|Secondary|Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment|The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|Only participants from the pharmacodynamic (PD) analysis set, who had available scores at each given time point, were analyzed for that time point. The PD analysis set included all patients with evaluable PD data with no protocol deviations that impacted PD data analysis.||total score||Standard Deviation|Mean
100765|NCT00809614|Secondary|SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment|SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Unit on a scale||Standard Deviation|Mean
100766|NCT00809614|Secondary|Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Unit on a Scale||Standard Deviation|Mean
100767|NCT00809614|Secondary|Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment|The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations||Units on a scale||Standard Deviation|Mean
100779|NCT00809458|Secondary|Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.|"Cardiovascular Effects/ Thrombophlebitis~Dermatologic Effects~Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps)~Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production~Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis)~Neurologic Effects (Dizziness, headache, fatigue or weakness~Ophthalmic Effects ( Blurred vision)~Respiratory Effects (Pulmonary embolism)"|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.|||||
100768|NCT00809614|Secondary|Percentage of Participants Who Achieved PsARC Response|"responder defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.||Percentage of participants|||Number
100769|NCT00809614|Secondary|Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocoldeviations.||Percentage of particpants|||Number
100770|NCT00809614|Primary|Percentage of PsARC Responders Per Treatment at Week 6|"Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity~A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.||Percentage of PsARC responders|||Number
100771|NCT00809614|Primary|Percentage of ACR Responders Per Treatment at Week 6|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.||Percentage of ACR responders|||Number
100772|NCT00809523|Primary|Percentage Change SIGH SAD Depression Rating|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.~Calculated: SIGH SAD score at trial end – SIGH SAD score at randomization x 100 / SIGH SAD score at randomization"|4 weeks|Intent to treat analysis last observation carried forward.||percentage of change on SIGH SAD||Standard Deviation|Mean
100773|NCT00809523|Secondary|Clinical Global Impression of Severity|The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.|Randomization and at 4 weeks|intent to treat analysis||units on a scale||Standard Deviation|Mean
100774|NCT00809523|Secondary|SIGH SAD Depression Rating|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly|Intent to treat analysis last observation carried forward.||units on a scale||Standard Deviation|Mean
100775|NCT00809471|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.||scores on a scale||Standard Deviation|Least Squares Mean
100776|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 Weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
100777|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12-weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
100793|NCT00809185|Secondary|Dose- and Non-dose-limiting Toxicities||at end of one cycle (28 days)||||||
100780|NCT00809458|Primary|Reduce Biomarkers of Prostate Cancer (PSA Blood Level)|PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.|30 days|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.|||||
100781|NCT00809445|Secondary|Self-Report of Ever Having Been Tested|The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.|1 month post-randomization|Number reporting having taken an HIV test, whether they received results or not, at one month follow-up. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively||participants|||Number
100782|NCT00809445|Secondary|Sharing of Needles Used in Drug Use|Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.|Six months|||n of people changing needle sharing|||Number
100783|NCT00809445|Primary|Number of Risky Sexual Behaviors|The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).|Six months post-randomization|All randomized participants who provided self-report of number of unprotected sex acts (vaginal or anal sex without a condom) at six-month follow-up are included.||number of unprotected sex acts||Standard Deviation|Mean
100784|NCT00809445|Primary|Self-Report Receipt of HIV Test Results|The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.|One month post-randomization|All randomized participants who provided self-report of either receipt or non-receipt of testing results at one month follow-up are included. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively||participants|||Number
100785|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."||percentageof participants||95% Confidence Interval|Number
100786|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
100787|NCT00809328|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.|Day 3|Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.||participants|||Number
100788|NCT00809328|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100"|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
100789|NCT00809328|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."||percentage of participants||95% Confidence Interval|Number
100790|NCT00809276|Primary|To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD|Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.|1 year|||percentage of participants||95% Confidence Interval|Number
100791|NCT00809185|Secondary|Bone Marrow Morphology and Cytogenetics Pre- and Post-therapy||at 2 years of treatment||||||
100792|NCT00809185|Secondary|Laboratory Correlates (Cytotoxic T-cell Populations, S6K1 Levels, GSTT-1 Mutations, and Presence or Absence of HLA-DR15)||at 2 years of treatment||||||
100794|NCT00809185|Primary|Number of Patients With Either a Major or Minor Erythroid Response(Hemoglobin Change From Baseline Measure)|"Major erythroid response: (1) For patients with a baseline hemoglobin less than 11 g/dL, a major erythroid response is defined as a > 2 g/dL increase in hemoglobin from baseline; or (2) 100% decrease in red blood cell transfusion requirements.~Minor erythroid response: (1) For patients with baseline hemoglobin less than 11 g/dL, a minor erythroid response is defined as an increase in hemoglobin greater than 1 g/dL but less than 2 g/dL from baseline; or (2) > 50% decrease in red blood cell transfusion requirements."|2 years of treatment|All patients enrolled were analyzed.||participants|||Number
100795|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.|"The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
100796|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.|"The Short Form (36) Health Survey (SF-36) measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
100797|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Day 8,15,29,week, 6, 10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
100798|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Score||Standard Deviation|Mean
100799|NCT00809159|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2|The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state using a visual analog scale (VAS) scale with 0 being very good and 100 being very bad.|Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||95% Confidence Interval|Least Squares Mean
100800|NCT00809159|Secondary|Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement|Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Score||Standard Deviation|Mean
100836|NCT00809133|Secondary|Part C: Carboplatin Cmax in Cycle 1 and Cycle 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100801|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day||Standard Deviation|Mean
100802|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day||Standard Deviation|Mean
100803|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters||Standard Deviation|Mean
100804|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters||Standard Deviation|Mean
100805|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters/day||Standard Deviation|Mean
100806|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||Liters/day||Standard Deviation|Mean
100807|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day*ug/mL||Standard Deviation|Mean
100808|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||day*ug/mL||Standard Deviation|Mean
100809|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||ug/mL||Standard Deviation|Mean
100810|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded||ug/mL||Standard Deviation|Mean
100811|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.||Days||Full Range|Median
100812|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.||Days||Full Range|Median
100813|NCT00809159|Secondary|Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1|The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation|Baseline, week 6, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Score||Standard Deviation|Mean
100814|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined|a Bayesian model was fitted to the ASAS20 , ASAS40 and ASAS 5/6 response rates on active and placebo treatments. A Bayesian analysis had been chosen to allow the direct incorporation into the analysis of information about placebo response rates from historical data|Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Participants|||Number
100815|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1|ASAS20 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Participants|||Number
100816|NCT00809159|Primary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2|ASAS20 as described in Primary Outcome. ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements||Units on a scale||95% Confidence Interval|Least Squares Mean
100817|NCT00809159|Primary|Percentage of Participants Who Achieved ASAS20 Response|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation||Percentage|||Number
100818|NCT00809146|Secondary|Length of Hospital Stay in Days|Continuous acute care inpatient hospital days from day of admission until discharge|participants were followed for the duration of hospital stay, an average of 6 days|All subjects with hospital length of stay data||days||Standard Deviation|Mean
100819|NCT00809146|Secondary|Length of Intensive Care Unit (ICU) Stay in Days|Continuous days of initial ICU stay from time of admission|participants were followed for the duration of hospital stay, an average of 6 days|All participants with ICU length of stay data||days||Standard Deviation|Mean
100820|NCT00809146|Secondary|Number of Subjects With IV Injection-site Complications|IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care.|participants were followed for the duration of hospital stay, an average of 6 days|||participants|||Number
100931|NCT00808483|Secondary|Stair Climbing Test (ST)|Ascend and descend 8 steps with a step hight of 16 cm as fast as they could without running. Few seconds (best) - many seconds (worse)|5 months and 12 months|||seconds||95% Confidence Interval|Mean
100821|NCT00809146|Secondary|Number of Subjects With IM Injection-site Complications|IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems.|participants were followed for the duration of hospital stay, an average of 6 days|||participants|||Number
100822|NCT00809146|Secondary|Number of Subjects With Hypotension|Acute hypotension is defined as a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor.|participants were followed for the duration of hospital stay, an average of 6 days|||participants|||Number
100823|NCT00809146|Secondary|Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival|Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival.|within 12 hours after ED arrival|||participants|||Number
100824|NCT00809146|Secondary|Number of Subjects Admitted to an Intensive Care Unit (ICU)|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at time of disposition on day of enrollment|||participants|||Number
100825|NCT00809146|Secondary|Number of Subjects Hospitalized|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at ED disposition on day of enrollment|||participants|||Number
100826|NCT00809146|Secondary|Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival|Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation.|anytime before 30 minutes after ED arrival|||participants|||Number
100827|NCT00809146|Primary|Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given|The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing.|Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).|||participants|||Number
100828|NCT00809133|Secondary|Objective Tumour Response (Confirmed)|"Number of subjects with confirmed objective tumour response.~Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR). Objective response was to be confirmed by a second tumour assessment at least 4 weeks after the assessment of CR or PR."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
100829|NCT00809133|Secondary|Objective Tumour Response (Unconfirmed)|"Number of subjects with objective tumour response (unconfirmed).~Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR)."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
100830|NCT00809133|Secondary|Part D: Carboplatin Cmax in Cycle 1 and 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100831|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100832|NCT00809133|Secondary|Part D: Paclitaxel Cmax in Cycle 1 and 2|Maximum measured concentration of Paclitaxel in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100833|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 23 Hours in Cycle 1 and Cycle 2|AUC0-23: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 23 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 23:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100834|NCT00809133|Secondary|Part D: Afatinib Cmax,ss|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100835|NCT00809133|Secondary|Part D: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State.|AUCt,ss: Area under the concentration-time curve of Afatinib at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100837|NCT00809133|Secondary|Part C: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100838|NCT00809133|Secondary|Part C: Afatinib Cmax,ss in Cycle 2|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100839|NCT00809133|Secondary|Part C: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State in Cycle 2|AUCt,ss: Area under the concentration-time curve of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100840|NCT00809133|Secondary|Part B: Bevacizumab Plasma Concentration|Bevacizumab plasma concentration after infusion of Bevacizumab 5mg/kg after end of 1st and 2nd infusion in Cycle 1.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||μg/mL||Inter-Quartile Range|Median
100841|NCT00809133|Secondary|Part B: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100842|NCT00809133|Secondary|Part B: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100843|NCT00809133|Secondary|Part B: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100844|NCT00809133|Secondary|Part B: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. There were no analyzable patients for Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100845|NCT00809133|Secondary|Part A: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100846|NCT00809133|Secondary|Part A: AUC0-24: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From Zero Extrapolated to 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100847|NCT00809133|Secondary|Part A: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
100848|NCT00809133|Secondary|Part A: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
100849|NCT00809133|Secondary|Incidence and Intensity of AEs According to the Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade|Incidence and Intensity of AEs (Adverse Events) graded according to the maximum CTCAE (Common Toxicity Criteria for Adverse Events) grade based on the number of patients with AEs with CTCAE Grade 1-5.|From first drug administration until the end of treatment cycle 1; 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
100850|NCT00809133|Primary|Maximum Tolerated Dose (MTD)|"The MTD of afatinib in selected combination treatments was defined as the highest dose at which no more than 1 out of 6 patients experienced DLTs during the first treatment cycle, i.e. the highest dose with a DLT incidence ≤17%. The MTD was determined separately for Afatinib in combination with Paclitaxel (part A), Afatinib in combination with Paclitaxel and Bevacizumab (part B), Afatinib and Carboplatin (part C), and Afatinib in combination with Paclitaxel and Carboplatin (part D).~In part C, dose escalation was not continued beyond the dose level A40C6, due to safety and pharmacokinetic considerations and upon mutual agreement between the investigators and the sponsor. Formally, no MTD was determined, however a recommended phase II dose was determined and is presented here.~0=not maximum tolerated dose, 1=is maximum tolerated dose~Note, the depicted order of treatment groups is driven by dose level, not by the actual dosing steps."|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Units on a scale|||Number
100851|NCT00809133|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Dose limiting toxicity (DLT) was defined as an Adverse Event (AE) or laboratory abnormality considered as related to study treatment.|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.||Participants|||Number
100852|NCT00809094|Other Pre-specified|Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group|Change in measure of estimated right ventricular pressure over the 24-week study period|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects. 1 subject in NAC cohort has missing data. It was not imputed||mm Hg||Standard Deviation|Mean
100853|NCT00809094|Other Pre-specified|Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group|Change in the diffusing capacity of carbon monoxide across the lung measured from baseline to end of 24-week study.|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects.||ml/min/mm Hg||Standard Deviation|Mean
100854|NCT00809094|Secondary|FEF 25-75% (Percent of Predicted)|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to the end of study (24 weeks).|Baseline to 24 weeks|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||percent of predicted||95% Confidence Interval|Mean
100855|NCT00809094|Secondary|FEF 25-75% (L/Sec)|Difference in mid-expiratory flow rates between 25 to 75% of the vital capacity, in L/sec measured at the beginning of the study to the end of the study.|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||L/sec||95% Confidence Interval|Mean
100856|NCT00809094|Secondary|FEV1 (L)|Forced expiratory volume in 1 second (Liters)|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||Liter||95% Confidence Interval|Number
100857|NCT00809094|Secondary|Change in FEV1 (Percent of Predicted for Age)|Change in forced expiratory volume in 1 second as compared to normals for age (percent of predicted)|From enrollment to the end of the 24-week trial|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||percent of predicted vlaues||95% Confidence Interval|Number
100858|NCT00809094|Primary|Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum|(change in log10 HNE in the active treatment group) – (change in log10 HNE in the placebo group)|From enrollment to end of the 24-week trial|The primary endpoint analyses described uses the subset of the ITT population with complete case data. 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.||log10 mcg/mL||95% Confidence Interval|Log Mean
100859|NCT00809055|Secondary|Bayley Scales of Infant Development Cognitive Score at 2 Years of Age|The cognitive portion of the Bayley Scales of Infant Development assesses development in infants and toddlers between the ages of 0 and 3 years. Raw scores are converted to scale scores. A scale score of 100 is designed to represent the population mean. Scores below 100 represent developmental delay relative to the mean and scores above 100 represent advanced development relative to the mean.|2 years|13 patients excluded from high-dose group (7 died, 2 withdrew, 2 we were unable to contact, 2 did not comply with scheduled appointments). 15 patients excluded from standard-dose group (5 died, 2 withdrew, 5 we were unable to contact, 3 did not comply with scheduled appointments).||score||Standard Deviation|Mean
100860|NCT00809055|Secondary|Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge|The Dubowitz Neurologic Examination is a standardized neurologic examination for infants at term age. It includes 6 compound optimality scores summed to obtain the total optimality score. Compound optimality scores include tone (range 0-10), tone pattern (range 0-5), reflexes (range 0-6), movements (range 0-3), abnormal signs (range 0-3), and behavior (range 0-7). The range for the compound optimality score is 0 - 34, with scores between 30.5 and 34 considered optimal and scores below 30.5 considered suboptimal.|Participants were followed for the duration of hospital stay, an average of 12 weeks|9 patients excluded from high-dose group (7 died, 2 withdrew). 6 patients excluded from standard-dose group (5 died, 1 transferred).||scores on a scale||Standard Deviation|Mean
100861|NCT00809055|Secondary|Evaluation of EEG Seizure Burden|For the first 72 hours of life, infants were monitored for seizures using continuous limited channel aEEG. Seizures were defined as a series of sharp waves, at least ten seconds in duration, which evolve in frequency, amplitude, and morphology over time and are clearly distinguishable from the background or artifact.|First 72 hours of life|7 patients excluded from high-dose group and 8 from standard-dose group due to recordings < 6 hours or corrupt data files.||seconds||Standard Deviation|Mean
100862|NCT00809055|Secondary|Rates of Retinopathy of Prematurity||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
100863|NCT00809055|Secondary|Rates of Necrotizing Enterocolitis||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
100864|NCT00809055|Secondary|Rates of Chronic Lung Disease|Defined as oxygen requirement at 36 weeks PMA|Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
100865|NCT00809055|Secondary|Length of Time Requiring Invasive Respiratory Support||Participants were followed for the duration of hospital stay, an average of 12 weeks|||days||Inter-Quartile Range|Median
100866|NCT00809055|Secondary|Cerebellar Hemorrhage||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
100867|NCT00809055|Secondary|Mortality Rates||Participants were followed for the duration of hospital stay, an average of 12 weeks|||participants|||Number
100868|NCT00809055|Primary|White Matter Microstructural Maturation|Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI.|Participants were followed for the duration of hospital stay, an average of 12 weeks|12 patients excluded from high-dose group (7 died, 2 withdrew, 3 insufficient image quality). 10 patients excluded from standard-dose group (5 died, 1 transferred, 1 parent refused MRI, 3 insufficient image quality).||apparent diffusion coefficient||Standard Deviation|Mean
100869|NCT00808899|Primary|Complete Response Plus Partial Response|The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.|10 years|The population consisted of patients eligible for enrollment onto the NB2008 protocol.||Participants|||Number
100870|NCT00808834|Primary|Comfort After Insertion|Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.|30-60 seconds after initial insertion|Per protocol||Scale 1-10||Standard Deviation|Mean
100871|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist||percent|||Number
100872|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist||percent|||Number
100873|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist||percent|||Number
100874|NCT00808808|Secondary|Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season||30Sep2008 through 23Dec2008|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not||percent|||Number
100875|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not||percentage points|||Number
100876|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees at participating sites, including those who completed surveys and those who did not||percentage points|||Number
100877|NCT00808808|Primary|Overall Vaccination Rate, Employees 18 to 49 Years of Age||30Sep2008 through 23Dec2008|All vaccinated employees at participating sites, including those who completed surveys and those who did not||Percentage of participants|||Number
100878|NCT00808808|Primary|Overall Vaccination Rate, All Ages||30Sep2008 through 23Dec2008|All employees at participating sites, including those who were vaccinated and those who were not||Percentage of participants|||Number
100879|NCT00808769|Primary|The Mean Percent Time Gastric pH > 4.0 on Day 1|In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.|continuously over a 24 hour period|Zeros are entered because the data are corrupted for 2 reasons: probe calibration failure rate was ~10x higher than historically documented, and the probes that calibrated had a high incidence of prolonged pH < 1.0 (highly physiologically improbable). This calls into question the credibility and interpretability of all the pH data.|||||
100880|NCT00808639|Secondary|Number of Patients Experiencing Surgery-related Toxicity|Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.|Surgery + 30 days|Number of patients who underwent cystectomy.||participants||90% Confidence Interval|Number
100881|NCT00808639|Secondary|Number of Patients Experiencing Febrile Neutropenia|Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)|||participants||90% Confidence Interval|Number
100882|NCT00808639|Primary|Number of Patients Achieving Pathologic Response|Pathological response is defined as down-staging to </=pT1, N0 after chemotherapy with pegfilgrastim support.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)|Analysis population consists of all enrolled patients.||percentage of pathologic responders||90% Confidence Interval|Number
100883|NCT00808509|Secondary|Change From Baseline in Radiological Modified Total Sharp Score|The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 52, and Weeks 104-156|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
100884|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Daily Activities|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
100932|NCT00808483|Secondary|Self-efficacy|Self-reported self-efficacy in activities. 0 (worse) - 100 (best).|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
100885|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Work Productivity|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.||units on a scale||Standard Deviation|Mean
100886|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Worked|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 4 asks participants who are employed or working for pay to indicate the number of hours actually worked during the past 7 days.|Baseline and at Weeks 12, 28, 52 and 104-156|Full analysis set participants employed or working for pay and with available data at each time point.||hours||Standard Deviation|Mean
100887|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.||hours||Standard Deviation|Mean
100888|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.||hours||Standard Deviation|Mean
100889|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Currently Employed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 1 asks participants to indicate if they are currently employed or working for pay (Yes or No).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100890|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100891|NCT00808509|Secondary|Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100892|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100893|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100894|NCT00808509|Secondary|Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100895|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100933|NCT00808483|Secondary|Harris Hip Score (HHS)|Pain and physical function. 0 (worse) - 100 (best)|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
100934|NCT00808483|Secondary|Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)|Self-reported symptoms, pain, physical function, function in sport and recreation, quality of life. 0 (worse) - 100 (best)|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
100896|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100897|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100898|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100899|NCT00808509|Secondary|Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100900|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100901|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100902|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100903|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100904|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100905|NCT00808509|Secondary|Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100906|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100907|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100908|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100909|NCT00808509|Secondary|Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100910|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100911|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Very Stiff at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100912|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis|Work Instability (defined as the mismatch between the person’s abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set||participants|||Number
100913|NCT00808509|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data.||units on a scale||Standard Deviation|Mean
100914|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100).|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
100915|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their anxiety/depression health state:~Level 1: I am not anxious or depressed;~Level 2: I am moderately anxious or depressed;~Level 3: I am extremely anxious or depressed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
100916|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their pain/discomfort health state:~Level 1: I have no pain or discomfort;~Level 2: I have moderate pain or discomfort;~Level 3: I have extreme pain or discomfort."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
100917|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state with regard to usual activities (work, study, housework, family, or leisure activities):~Level 1: I have no problems performing my usual activities;~Level 2: I have some problems performing my usual activities;~Level 3: I am unable to perform my usual activities."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
100918|NCT00808509|Primary|Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set 2 (FAS2), defined as participants in the full analysis set who completed at least 28 weeks of the study or completed the study until flare, whichever occurs first.||percentage of participants||95% Confidence Interval|Number
100919|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their self-care health state:~Level 1: I have no problems with self-care;~Level 2: I have some problems washing or dressing myself;~Level 3: I am unable to wash or dress myself."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
100935|NCT00808483|Primary|6 Minutes Walk Test (6MWT)|Participants walked in a 40 meter hospital corridor for 6 minutes.|5 months and 12 months|||meters||95% Confidence Interval|Mean
102282|NCT00795951|Primary|Diagnostic Performance: Potassium Dichromate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
100920|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state:~Level 1: I have no problems in walking about;~Level 2: I have some problems in walking about;~Level 3: I am confined to bed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set||participants|||Number
100921|NCT00808509|Secondary|Health Assessment Questionnaire (HAQ) Total Score by Visit|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.||units on a scale||Standard Deviation|Mean
100922|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare|For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.||percentage of participants||95% Confidence Interval|Number
100923|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare|"For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy).~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity."|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.||percentage of participants||95% Confidence Interval|Number
100924|NCT00808509|Secondary|Number of Participants With a Flare|Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52|Full analysis set; N indicates the number of participants with available data at each time point.||participants|||Number
100925|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Also, participants who did not complete 52 weeks were considered not in remission.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52."|Week 52|Full analysis set 2||percentage of participants||95% Confidence Interval|Number
100926|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission."|Week 52|Full analysis set||percentage of participants||95% Confidence Interval|Number
100927|NCT00808509|Primary|Percentage of Participants in Remission at Week 28|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set (FAS), defined as all participants who received at least one dose of adalimumab and/or methotrexate and had at least one post-baseline observation.||percentage of participants||95% Confidence Interval|Number
100928|NCT00808483|Secondary|Figure-of-eight Test|Test of dynamic balance. Number of steps on and outside the line is registered. 0 (best)|5 months and 12 months|||steps||95% Confidence Interval|Mean
100929|NCT00808483|Secondary|Index of Muscle Function (IMF)|Tests of general mobility, muscle strength, balance/coordination, and endurance. 40 (worse) - 0 (best)|5 months and 12 months|||units on a scale||95% Confidence Interval|Mean
100930|NCT00808483|Secondary|ROM Extension|Active range of motion (ROM) in hip extension test. Degrees is registered. 0 degrees indicates zero position of the hip, minus digrees indicates flexion contracture.|5 months and 12 months|||degrees||95% Confidence Interval|Mean
100936|NCT00808444|Secondary|Occurrence of Unsolicited Adverse Events|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||subjects|||Number
100937|NCT00808444|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentrain was expressed as GMC in µg/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
100938|NCT00808444|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)|Concentrations are expressed as GMCs in EL.U/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Least Squares Mean
100939|NCT00808444|Secondary|Number of Subjects With Solicited Local and General Symptoms.|"Solicited local symptoms were pain, redness and swelling.~Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting."|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which inlcuded all vaccinated subjects.||subjects|||Number
100940|NCT00808444|Secondary|Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes|"Titers are presented as Geometric Mean Titers (GMTs).~Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
100941|NCT00808444|Secondary|Occurrence of Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following vaccination and throughout the entire study period (Month 0 to Month 4)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.||subjects|||Number
100942|NCT00808444|Secondary|Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)|Concentration was expressed as GMC in units per milliliter (U/mL).|3 months after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||U/mL||95% Confidence Interval|Geometric Mean
100943|NCT00808444|Secondary|Concentration of Antibody Against Hepatitis B Surface Antigen (HBs)|Concentration was given as GMC in milli international units per milliliter (mIU/mL).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||mIU/mL||95% Confidence Interval|Geometric Mean
100944|NCT00808444|Secondary|Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)|Concentrations were defined as GMCs in international units per milliter (IU/mL)|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
100945|NCT00808444|Secondary|Poliovirus Types 1, 2 and 3 Titers|Titers were given as Geometric Mean Titers (GMTs).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
100946|NCT00808444|Secondary|Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes|"Opsonophagocytic titers were expressed as GMTs.~Cross-reactive pneumococcal serotypes included 6A and 19A."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
100947|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|"Cross-reactive pneumococcal serotypes were 6A and 19A.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
100948|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
100949|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL|Anti-pneumococcal cross-reactive serotypes were 6A and 19A.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
100950|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL|Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
100951|NCT00808444|Primary|Concentration of Antibody Against Protein D (PD)|Concentration was expressed as GMC in GSK’s 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
100952|NCT00808444|Primary|Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine|"Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL).~Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.||μg/mL||95% Confidence Interval|Geometric Mean
100953|NCT00808405|Secondary|Time to First Negative Herpes Simplex Virus (HSV) DNA PCR|To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.||Days||Standard Error|Mean
100954|NCT00808405|Primary|Time to Healing of Genital Lesions|To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.||Days||Standard Error|Mean
100955|NCT00808340|Primary|Overall Subjective Vision|Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|after 1 week of lens wear, for each lens type|||Units on a scale||Standard Error|Least Squares Mean
100956|NCT00808340|Primary|Type of Corneal Staining|Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).|after 1 week of lens wear, for each lens type|||Units on a scale||Standard Error|Least Squares Mean
100957|NCT00808340|Primary|Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion|||logMAR||Standard Error|Least Squares Mean
100958|NCT00808340|Primary|Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion|||logMAR||Standard Error|Least Squares Mean
100959|NCT00808249|Secondary|Change in Sheehan Disability Scale (SDS) Global Total Score|The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)|From baseline ( randomization) to week 4|||Units on scale||Standard Error|Least Squares Mean
100960|NCT00808249|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score|The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms|From baseline ( randomization) to week 4|||Units on scale||Standard Error|Least Squares Mean
100961|NCT00808249|Secondary|Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score|The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.|From baseline (randomization) to week 4|||Unit on scale||Standard Error|Least Squares Mean
100962|NCT00808249|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.|From randomization (baseline) to week 4|||Units on scale||Standard Error|Least Squares Mean
100963|NCT00808249|Primary|Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.|From randomization (baseline) to week 4|||Units on scale||Standard Error|Least Squares Mean
100964|NCT00808236|Post-Hoc|Outcomes for Patients Receiving EMS CPR Within 10 Minutes of Collapse That Were Admitted to the Hospital||Hospital Discharge|Subset of patients that received EMS CPR within 10 minutes of collapse, achieved ROSC, and were subsequently admitted to the hospital.||participants|||Number
100965|NCT00808236|Post-Hoc|Outcomes for VF Patients Admitted to the Hospital|Survival and neurologically-intact survival for patients found in VF/VT admitted to the hospital|Hospital discharge|Subset of patients with an initial rhythm of VF/VT, achieved ROSC and were subsequently admitted to the hospital||participants|||Number
100966|NCT00808236|Post-Hoc|Outcomes for Patients Admitted to the Hospital|Suvival and neurologically intact survival|Hospital discharge|Subset of patients that achieved ROSC and were subsequently admitted to the hospital.||participants|||Number
100967|NCT00808236|Secondary|24-hour Adverse Events (AE)|These were all non-serious adverse events that occurred between the time of enrollment and 24 hours after resuscitation. These did not include a failure to achieve ROSC.|24 hours after arrest|all enrolled participants||all participants|||Number
100968|NCT00808236|Secondary|Serious Adverse Events (SAEs)|These were defined serious adverse events that are not direct sequelae of the cardiac arrest itself or the underlying cardiac disease. Therefore, these do not include recurrent arrests occcuring within 24 hours of resuscitation nor deaths due to lack of cardiac and/or neurological recovery.|7 days after arrest|"All enrolled patients; see additional modified at risk population based on study attrition in the Adverse Event section."||all participants|||Number
100970|NCT00808236|Secondary|Length of Stay|"Length of stay data for patients admitted to the hospital will be calculated for:~Days on ventilator~Days in intensive care without ventilator~Days in general ward"|Hospital Discharge|Evaluable patients admitted to the hospital||days||Inter-Quartile Range|Median
100971|NCT00808236|Secondary|Time to Therapeutic Temperature|The therapeutic temperature range for treatment in cardiac arrest is considered to be 32-34C. Time to therapeutic temperature was taken as the first time in which 34C was measured. Tympanic and core temperatures were taken in all patients.|within 8 hours after enrollment|The subset of patients that were resuscitated and subsequently received in-hospital cooling and reached the designated therapuetic temperatures.||minutes||Inter-Quartile Range|Median
100972|NCT00808236|Secondary|Primary Outcomes in Sub-group With VF/VT as First Rhythm|ROSC, survival, and neurologically-intact survival|hospital discharge|Subset of all included patients with VF/VT as the first cardiac rhythm present upon ECG assessment by EMS personnel||participants|||Number
100973|NCT00808236|Primary|Survived Neurologically-Intact|"The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered neurologically intact.~- Good cerebral performance: little to no deficit.~- Moderate cerebral disability: capable of independent activities of daily life~- Severe cerebral disability: conscious, but dependent on others for daily support~- Coma or vegetative state~- Death or brain death"|30-days after arrest|The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn.||participants|||Number
100974|NCT00808236|Primary|Survived to Hospital Discharge|The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.|30 days after arrest|"The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn. One RhinoChill patient that achieved ROSC was found to be DNAR upon hospital arrival and was excluded from analyses thereafter. The final number of analyzed RhinoChill patients was therefore 82."||participants|||Number
100975|NCT00808236|Primary|Achieve Return of Spontaneous Circulation (ROSC)|ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.|1-hour after arrest|Only patients meeting all inclusion/exclusion criteria (IC/EC) were included in the analyses. 15 patients were found to not meet all IC/EC after enrollment. 2 more patients were lost to follow-up and 1 patient was crossed over (Control to RhinoChill) and then withdrawn. Informed consent nor data was obtained for any of these patients.||participants|||Number
100976|NCT00808132|Secondary|Percentage of Participants With Uterine Bleeding|Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.|Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm respectively.||Percentage of Participants|||Number
100977|NCT00808132|Secondary|Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline, Month 3|"MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N: maximum number of participants who were evaluable for this outcome and n: participants who were evaluable at specified time points for each arm."||Units on a Scale||Standard Error|Least Squares Mean
100978|NCT00808132|Secondary|Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.||Units on a Scale||Standard Deviation|Mean
100979|NCT00808132|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline, Month 3|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.||Units on a Scale||Standard Error|Least Squares Mean
100980|NCT00808132|Other Pre-specified|Percentage of Participants With Breast Tenderness|Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.|Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline.||Percentage of Participants|||Number
100981|NCT00808132|Secondary|Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.||Units on a Scale||Standard Deviation|Mean
100982|NCT00808132|Secondary|Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study|Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.|Baseline, Month 6, 12|"MITT for osteoporosis substudy. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm respectively."||Percent Change||Inter-Quartile Range|Median
100983|NCT00808132|Secondary|Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study|Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study|Baseline, Month 12|"Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here N signifies participants who were evaluable for this outcome measure."||Percent Change||Standard Error|Least Squares Mean
100984|NCT00808132|Secondary|Percentage of Participants With Cumulative Amenorrhea: Main Study|Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.|Day 1 up to Day 364|MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
100985|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study|BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6, Month 12|"MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here n signifies participants who were evaluable at specified time points for each arm, respectively."||Percent Change||Standard Error|Least Squares Mean
100986|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6|"MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here N signifies participants who were evaluable for this outcome measure."||Percent Change||Standard Error|Least Squares Mean
100987|NCT00808132|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 12|Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.||Percent Change||Standard Error|Least Squares Mean
101002|NCT00808067|Secondary|Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
102283|NCT00795951|Primary|Diagnostic Performance: Wool Alcohol|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All enrolled subjects||participants|||Number
100988|NCT00808132|Primary|Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.|Month 12|Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
100989|NCT00808080|Secondary|If Phase I Has Successfully Shown the Target Dose to be Below the MTD Continue Enrolling Until 38 Patients Have Received the Target Dose. Patients Will be Monitored for Safety and Efficacy.||2.5 years estimated||||||
100990|NCT00808080|Primary|6 Dose Cohorts for Safety Monitoring. Each Cohort is Assessed for DLT for One Month After Autologous Cultured CTL Infusion Prior to Enrolling the Next Cohort.||2.5 years estimated|Not Applicable as none of the enrolled patients became eligible for infusion|||||
100991|NCT00808067|Secondary|Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100992|NCT00808067|Secondary|Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100993|NCT00808067|Secondary|Annualized Rate of Subjects With Minor Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100994|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100995|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100996|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100997|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100998|NCT00808067|Secondary|Death, Annualized Rate of Subject Death|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
100999|NCT00808067|Secondary|Deep Vein Thrombosis, Annualized Rate of Subjects With DVT|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deep Vein Thrombosis (DVT) was generally documented by one of the following:~abnormal compression ultrasound (CUS),~an intraluminal filling defect on venography."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
101000|NCT00808067|Secondary|Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
101001|NCT00808067|Secondary|Pulmonary Embolism (PE), Annualized Rate of Subjects With PE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Pulmonary Embolism was generally documented by one of the following:~an intraluminal filling defect in segmental or more proximal branches on spiral CT scan~an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram~a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)~inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography."|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
101003|NCT00808067|Secondary|Stroke, Annualized Rate of Subjects With Stroke|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital"|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
101004|NCT00808067|Primary|Major Bleeding, Annualized Rate of Subjects With Major Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Major bleeding must have satisfied one or more of the following criteria:~Bleeding associated with a reduction in hemoglobin of at least 20 g/L~Required transfusion of at least 2 units of blood or packed cells~Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal~Major bleed were classified as life-threatening if they met one or more of the following criteria:~Reduction in hemoglobin of at least 50 g/L~Transfusion of at least 4 units of blood or packed cells~Symptomatic intracranial bleeding, either subdural or intracerebral~Associated with hypotension requiring use of intravenous inotropic agents~Required surgical intervention to stop bleeding~Resulted in death"|up to 43 months|SAF-FAS interval||percentage of subject-years|||Number
101005|NCT00808028|Other Pre-specified|Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B||Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Titer||95% Confidence Interval|Geometric Mean
101006|NCT00808028|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level||1 month before vaccination 1, 1 month after vaccination 2, 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Percentage of participants|||Number
101007|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 2||6 month after vaccination 3 up to 48 months|Safety population included participants who received at least 1 dose of study vaccine.||Percentage of participants|||Number
101008|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 1||Vaccination 1 upto 1 Month after vaccination 3|Safety population included participants who received at least 1 dose of study vaccine.||Percentage of participants|||Number
101009|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3||Before vaccination 1 up to 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Percentage of participants|||Number
101010|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2||Before vaccination 1 up to 1 month after vaccination 2|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.||Percentage of participants|||Number
101011|NCT00808015|Other Pre-specified|Concomitant Drug Treatments||Baseline through Last observed study visit (Week 12 or ET)|FAS included all participants who received at least 1 dose of study medication.||Participants|||Number
101012|NCT00808015|Other Pre-specified|Median Duration of Treatment of Varenicline|The duration was defined as the total number of dosing days from first to last day of each study treatment.|Baseline through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis.||Days||Full Range|Median
101013|NCT00808015|Other Pre-specified|Average Daily Dose of Varenicline||Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||mg||Full Range|Median
101014|NCT00808015|Other Pre-specified|Varenicline Prescription Status|Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'.|After last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication.||participants|||Number
101015|NCT00808015|Secondary|Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit|The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No).|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=518).||cigarettes||Full Range|Median
101016|NCT00808015|Secondary|CO Level at Last Observed Study Visit|The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site.|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=115).||ppm||Standard Deviation|Mean
101017|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 3 through Week 11|At Week t (t = 3 to 11), the analysis population was “Observed Cases minus Week t” (OC minus Week t), that is (i-e), participants in FAS excluding missing values at the time point in question where OC was the subset of participants in FAS with observed (not missing) values.||percentage of participants|||Number
101018|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Last observed study visit (Week 12 or early termination [ET])|FAS included all participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
101019|NCT00808015|Primary|Percentage of Participants With Smoking Abstinence at Week 12|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication||percentage of participants||95% Confidence Interval|Number
101020|NCT00807989|Secondary|Seizure Free Rate for 52 Weeks at Initial Target Dose||52 weeks|||participants|||Number
101021|NCT00807989|Secondary|Seizure Free Rate for 24 Weeks at Initial Target Dose||24 weeks|||participants|||Number
101022|NCT00807989|Primary|Retention Rate After 52 Weeks Maintenance Period|* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.|52 weeks|||participants|||Number
101023|NCT00807937|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.~Change : percentage at week 4 minus percentage at randomization"|Baseline to week 4|||percentage||Standard Error|Least Squares Mean
101024|NCT00807937|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
101025|NCT00807937|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|"The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.~Change: score at week 4 minus score at randomization"|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
101026|NCT00807937|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
101027|NCT00807937|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization|Baseline to week 4|||Units on scale||Standard Error|Least Squares Mean
101028|NCT00807885|Secondary|Time Required to Infuse 1000 mL Fluid||from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused|ITT (all treated subjects)||hours||Standard Deviation|Mean
101029|NCT00807885|Secondary|Time Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)||seconds||Full Range|Median
101030|NCT00807885|Secondary|Attempts Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)||participants|||Number
101031|NCT00807885|Primary|Technical Challenges|Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered|throughout subcutaneous hylenex and fluid administration period (continuous)|ITT (all treated subjects)||participants|||Number
101032|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).||bpm||Standard Deviation|Mean
101033|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).||mmHg||Standard Deviation|Mean
101034|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.||bpm (beats per minute)||Standard Deviation|Mean
101035|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.||mmHg||Standard Deviation|Mean
101036|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.|Week 6/Final Visit|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.||Participants|||Number
101037|NCT00807846|Secondary|Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.|6 weeks|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.||mm||Standard Error|Least Squares Mean
101038|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Parent’s Global Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.|Week 6/Final Visit|The MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.||Participants|||Number
101039|NCT00807846|Secondary|Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.|6 weeks|Modified-Intent-to-Treat (MITT) Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.||mm (millimeter)||Standard Error|Least Squares Mean
101040|NCT00807846|Secondary|Change From Baseline in DBP at Week 6/Final Visit|Value at 6 weeks/Final Visit minus value at baseline.|6 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
101041|NCT00807846|Secondary|Change From Baseline in DBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
101042|NCT00807846|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
101043|NCT00807846|Secondary|Change From Baseline in SBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
101044|NCT00807846|Secondary|Change From Baseline to Week 2 in SBP.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."||mmHg||Standard Error|Least Squares Mean
101045|NCT00807846|Primary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit|Value at 6 weeks minus value at baseline.|6 Weeks/Final Visit|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP (blood pressure) measurements.~For early terminations the last observation carried forward (LOCF) was used to impute missing data."||mmHg (millimeter of mercury)||Standard Error|Least Squares Mean
101046|NCT00807573|Primary|Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||participants|||Number
101047|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|up to 44 weeks|||percentile||Standard Deviation|Mean
101048|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)|up to 44 weeks|||Z-score||Standard Deviation|Mean
101049|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|baseline|||percentile||Standard Deviation|Mean
101050|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.|up to 44 weeks|||kg/m^2||Standard Deviation|Mean
101051|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.|baseline|||kg/m^2||Standard Deviation|Mean
101052|NCT00807560|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI z score.|up to 44 weeks|||pounds||Standard Deviation|Mean
101053|NCT00807560|Secondary|Weight|This variable informs the calculation for the outcome variable of BMI Z score.|baseline|||pounds||Standard Deviation|Mean
101054|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|up to 44 weeks|||inches||Standard Deviation|Mean
101055|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).|baseline|||Z-score||Standard Deviation|Mean
101056|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|Baseline|||inches||Standard Deviation|Mean
101057|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|up to 44 weeks|||inches||Standard Deviation|Mean
101058|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|baseline|||inches||Standard Deviation|Mean
101059|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|up to 44 weeks|||inches||Standard Deviation|Mean
101060|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|baseline|||inches||Standard Deviation|Mean
101061|NCT00807560|Secondary|Percent Completion|Percent of participants who completed the trial to assess feasibility and retention in the trial|at 44 weeks|||percentage of participants|||Number
101062|NCT00807456|Primary|Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement|Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant (the rim (R), i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.|At baseline and 16 weeks|||millimeter|Participants|Standard Deviation|Mean
101063|NCT00807248|Secondary|Clinical Global Impression - Global Improvement (CGI-I)|The CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|at Week 8|At Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
101064|NCT00807248|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
101065|NCT00807248|Secondary|SDS: Social Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
101066|NCT00807248|Secondary|SDS: Work Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
101067|NCT00807248|Secondary|Sheehan Disability Scale (SDS): Family Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
101536|NCT00803114|Secondary|Maternal Satisfaction With Perineal Pain Management|"5 point Likert scale asking for agreement with the statement I was satisfied with my pain relief for the pain in my bottom during the first day after delivery. Scale ranged from strongly disagree to strongly agree."|at 24 hours postpartum|||participants|||Number
101068|NCT00807248|Secondary|Insomnia Severity Index (ISI)|The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient’s perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
101069|NCT00807248|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Mean
101070|NCT00807248|Secondary|MADRS|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|From baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)||Scores on a scale||Standard Error|Least Squares Mean
101071|NCT00807248|Primary|Montgomery and Åsberg Depression Rating Scale (MADRS)|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|Baseline to 8 weeks|Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA)||Scores on a scale||Standard Error|Mean
101072|NCT00807235|Secondary|Number of Participants With Air Leak||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101073|NCT00807235|Secondary|Incidence of Mortality||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101074|NCT00807235|Secondary|Number of Participants With Acquired Sepsis||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101075|NCT00807235|Secondary|Number of Participants With Pulmonary Hemorrhage||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101076|NCT00807235|Secondary|Number of Participants With Necrotizing Enterocolitis (NEC)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101077|NCT00807235|Secondary|Number of Participants With Patent Ductus Arteriosus (PDA)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101078|NCT00807235|Secondary|Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101079|NCT00807235|Secondary|Number of Participants Alive and Without BPD||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101080|NCT00807235|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101081|NCT00807235|Secondary|Time to Meet Failure Criteria|Failure criteria defined as rescue with bolus surfactant and mechanical ventilation|Through 28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat). Time in days calculated for neonates who met failure criteria (3 for Regimen 1, 2 for Regimen 2)"||days||Standard Deviation|Mean
101082|NCT00807235|Secondary|Arterial Alveolar (a/A) O₂Ratio|a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.|72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||mm Hg over mm Hg (ratio of pressures)||Standard Deviation|Mean
101083|NCT00807235|Secondary|Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||percent O₂*hours||Standard Deviation|Mean
101084|NCT00807235|Primary|Number of Participants With Respiratory Distress Syndrome||24 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."||participants|||Number
101085|NCT00807209|Primary|Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.|The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.|72 hours|||micrograms|||Number
101086|NCT00807092|Secondary|Hypoglycaemia Based on Self-reported Episodes|Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified as major, minor or symptoms only: Major if the subject was unable to treat her/himself; minor if subject was able to treat her/himself and self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L.|Weeks 0-6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).||episodes|||Number
101087|NCT00807092|Secondary|Duration of Hypoglycaemic Events Based on CGMS|The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively).|72-hour monitoring period at Week 0 and Week 6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).||Hours||Standard Error|Least Squares Mean
101088|NCT00807092|Secondary|Change in Glycosylated Haemoglobin (HbA1c)||Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||percentage point change||Standard Error|Least Squares Mean
101089|NCT00807092|Secondary|Change in GA (Glycated Albumin)|Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed.|Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||percentage point change||Standard Error|Least Squares Mean
101090|NCT00807092|Secondary|Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS|MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
101091|NCT00807092|Secondary|Change in Prandial Blood Glucose Increment|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
101092|NCT00807092|Secondary|Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products||mmol/L||Standard Error|Least Squares Mean
101093|NCT00807092|Secondary|Change in FPG (Fasting Plasma Glucose)|FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
101094|NCT00807092|Secondary|Change in Mean FBG Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 0, week 6|||mmol/L||Standard Error|Least Squares Mean
101095|NCT00807092|Secondary|Mean FBG (Fasting Blood Glucose) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
101096|NCT00807092|Secondary|Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
101118|NCT00806819|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
101097|NCT00807092|Primary|Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals|The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period|Week 0, week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||mmol/L||Standard Error|Least Squares Mean
101098|NCT00807014|Secondary|Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination|Participants were evaluated for overall tolerance to study drug by the investigator at the end of the study (Week 12 or Early Termination). Participants were given the tolerance grades of poor, fair, good, or excellent.|Week 12 or Early Termination|ITT Population. Some participants had no data available and were thus excluded from analysis.||participants|||Number
101099|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning|Tolerance symptoms of itching and burning were evaluated at each visit by participants. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).||scores on a scale||Standard Deviation|Mean
101100|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness|Tolerance symptoms of peeling (flaking), erythema (redness of skin), and dryness were evaluated at each visit by the investigator. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).||scores on a scale||Standard Deviation|Mean
101101|NCT00807014|Secondary|Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System|The acne grade on the participant’s face was assessed by the investigator using the LRAG, a photographic scale allowing for the assessment of the clinical status for acne severity for the face, back, and chest. It consists of a 12-grade scale (1, least severe; 12, most severe) for inflammatory visible lesions (les.). For non-inflammatory les., this scale comprises 3 photos of les. of increasing severity (grades 1-3). The scale provides a qualitative assessment of superficial/visible les. and provides consistency and inter-/intra-rater reliability. Grading was performed prior to les. counting.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.||scores on a scale||Standard Deviation|Mean
101102|NCT00807014|Secondary|Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
101103|NCT00807014|Secondary|Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Global change in acne improvement was assessed by the investigator on a 7-point scale: 1=greatly worsened, 2=significantly worsened, 3=slightly worsened, 4=no change, 5=slightly improved, 6=significantly improved, or 7=greatly improved. Global change at the indicated week was assessed in terms of change from the previous week. Change at Week 2, for example, was an assessment of change from Week 1.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.||scores on a scale||Standard Deviation|Mean
101104|NCT00807014|Secondary|Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2|Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman’s correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation.|Baseline (Week 0) and Week 2|ITT Population. Missing values were imputed using the LOCF method. One participant in the Differin group had no data available and was thus excluded from analysis.||Correlation coefficient|||Number
101105|NCT00807014|Secondary|Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions (IL) included papules, pustules, nodules, and cysts. Non-inflammatory lesions (NIL) included closed comedones (whiteheads) and open comedones (blackheads). Total lesion count was calculated as the sum of IL and NIL. Percent change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline divided by Baseline value * 100.|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Some participants had no baseline lesions of an individual type; percent change from baseline is undefined for these participants. All participants, however, had at least one type of lesion; thus, all participants in the ITT Population were analyzed for total lesion count.||percent change in lesions||Standard Deviation|Mean
101106|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions included papules, pustules, nodules, and cysts. Non-inflammatory lesions included closed comedones (whiteheads) and open comedones (blackheads). The total lesion count was calculated as the sum of inflammatory and non-inflammatory lesions. Change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline (Week 0).|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.||lesions||Standard Deviation|Mean
101107|NCT00807014|Secondary|Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). One participant in the Differin arm had no QoL data available and was thus excluded from analysis.||scores on a scale||Standard Deviation|Mean
101108|NCT00807014|Primary|Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 2|Intent-to-Treat (ITT) Population: all randomized participants (par.) who applied >= 1 dose of study product. Missing values were imputed using the last observation carried forward (LOCF, i.e., the last available observation was used to estimate subsequent missing data points) method. 1 par. in the Differin arm had no QoL data and was not analyzed.||scores on a scale||Standard Deviation|Mean
101109|NCT00807001|Secondary|Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)|Measures how much virus is in the blood.|Baseline to 4 days|efficacy evaluable population = a) must have received all 3 doses of study drug b) must have baseline and at least one post-baseline HCV RNA determination||log10 IU/mL||Standard Deviation|Mean
101110|NCT00807001|Primary|Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events|Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening|17 days|Safety population consisted of all subjects who received at least one dose of study drug.||participants|||Number
101111|NCT00806819|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 36 months|Treated set uncut - all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.||% of participants|||Number
101112|NCT00806819|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
101113|NCT00806819|Secondary|Quality of Life (QoL)|"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
101114|NCT00806819|Secondary|Clinical Improvement.|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
101115|NCT00806819|Secondary|Change From Baseline in Tumour Size|Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||percentage of change in tumor size in mm||95% Confidence Interval|Mean
101116|NCT00806819|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
101117|NCT00806819|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||% of participants|||Number
101119|NCT00806819|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
101120|NCT00806819|Secondary|Objective Tumor Response|Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator|From randomisation until data cut-off (15 February 2013), Up to 30 months|Randomised Set||% of participants|||Number
101121|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
101122|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||Months||Inter-Quartile Range|Median
101123|NCT00806819|Secondary|Overall Survival (Key Secondary Endpoint)|Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS||months||Inter-Quartile Range|Median
101124|NCT00806819|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 9 July 2012|RS||months||Inter-Quartile Range|Median
101125|NCT00806624|Secondary|Evaluation of All Clinical and Laboratory Safety Data.||6 months||||||
101126|NCT00806624|Secondary|Evaluation of Effects on Pharmacodynamic Biomarkers||6 months||||||
101127|NCT00806624|Secondary|Evaluation of Plasma Concentration of DU-176||6 months||||||
101128|NCT00806624|Secondary|Evaluation of Effects on Biomarkers of Thrombus Formation||6 months||||||
101129|NCT00806624|Secondary|Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition||6 months||||||
101130|NCT00806624|Primary|Incidence of All Bleeding|Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF.|6 months|The Safety Analysis Set was defined as all subjects who received at least one dose of study drug and had at least one post-dose safety assessment. The primary endpoint were analyzed for the subjects who proceeded to the treatment period in the Safety Analysis Set.||percentage of subjects with bleeds||95% Confidence Interval|Number
101131|NCT00806598|Primary|Overall Response|Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.|Of the 48 participants who received treatment 46 were evaluable for response.||participants|||Number
101132|NCT00806585|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and did not lack of any endpoint data (both baseline and post-randomization)||Percentage Change||Standard Error|Least Squares Mean
101133|NCT00806585|Secondary|Change From Baseline in Body Weight at Week 24|Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||kg||Standard Error|Least Squares Mean
101134|NCT00806585|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||Percentage Change||Standard Error|Least Squares Mean
101135|NCT00806585|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||mmHg||Standard Error|Least Squares Mean
101641|NCT00802360|Primary|Percentage of Participants With Ongoing Pregnancy at Week 8|The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.|Week 8 (Week 6 of gestation)|Intent to treat population||percentage of participants|||Number
101136|NCT00806585|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)||mmHg||Standard Error|Least Squares Mean
101137|NCT00806546|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch application|Per protocol, all subjects who applied at least one NP101 study patch were included in the safety population.||scores on a scale|Participants|Standard Deviation|Mean
101138|NCT00806494|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.|Baseline, Week 12|FAS. n=number of participants with analyzable data.||Score on Scale||95% Confidence Interval|Mean
101139|NCT00806494|Secondary|Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12|TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to ‘Satisfied’ (including ‘very satisfied’ and ‘somewhat satisfied’) and ‘Dissatisfied’ (including ‘very dissatisfied’,‘somewhat dissatisfied’, and ‘neither dissatisfied nor satisfied’). Percentage of participants reporting satisfaction included those with categorical responses of ‘very satisfied’ and ‘somewhat satisfied’.|Week 12 (or Early Withdrawal)|FAS. N=number of participants with analyzable data.||Percentage of Participants|||Number
101140|NCT00806494|Secondary|Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire|BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).|Week 12 (or Early Withdrawal)|FAS, LOCF.||Participants|||Number
101141|NCT00806494|Secondary|Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12|ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.|Baseline, Week 12|FAS. N=number of participants with analyzable data.||Score on Scale||95% Confidence Interval|Mean
101142|NCT00806494|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12|OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.|Baseline, Week 4 and Week 12|FAS. N=number of participants with baseline score. n=number of participants analyzed at specified timepoint. Missing data at Week 12 imputed using LOCF approach.||Score on Scale||95% Confidence Interval|Mean
101143|NCT00806494|Secondary|Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12|UPS: self-administered, single-item questionnaire to measure participant’s perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Participants|||Number
101144|NCT00806494|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12|PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Participants|||Number
101145|NCT00806494|Secondary|Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12|The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Incontinence Pads||95% Confidence Interval|Mean
101146|NCT00806494|Secondary|Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
101147|NCT00806494|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12|SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
101148|NCT00806494|Secondary|Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
101149|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12|"NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).~Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
101150|NCT00806494|Secondary|Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with urgency episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
101151|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12|Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with urgency episodes >=3 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
101152|NCT00806494|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
101153|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12|"UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).~Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of Episodes||95% Confidence Interval|Mean
101154|NCT00806494|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
101188|NCT00806078|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)|AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol||ng-h/ml||Standard Deviation|Mean
101155|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Number of episodes||95% Confidence Interval|Mean
101156|NCT00806494|Secondary|Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.||Percentage Change||95% Confidence Interval|Mean
101157|NCT00806494|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 4|FAS. N=number of participants with analyzable data.||Number of Episodes||95% Confidence Interval|Mean
101158|NCT00806494|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 12|Full analysis set (FAS)=participants who took at least one dose of study drug and provided baseline and post-baseline data for at least 1 efficacy endpoint. N=number of participants with analyzable data. Missing data at Week 12 were imputed using last (valid post-baseline) observation carried forward (LOCF) approach.||Number of Episodes||95% Confidence Interval|Mean
101159|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).|||ng/mL||Standard Deviation|Least Squares Mean
101160|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|"Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.~Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose."|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).|Twenty-eight (28) subjects (excluding 2 that were enrolled but did not complete both study periods) were included in the statistical analysis.||ng*hr/mL||Standard Deviation|Least Squares Mean
101161|NCT00806416|Primary|Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet|Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.|On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).|Two hundred-seven (207) subjects (excluding 7 that were enrolled but did not complete both study periods) were included in the statistical analysis.||micrograms (μg)||Standard Deviation|Least Squares Mean
101162|NCT00806403|Secondary|Stroke||30 days|Analysis made on intention to treat (ITT) basis.||Participants|||Number
101163|NCT00806403|Secondary|Reinfarction||30 days|Analysis made on intention to treat (ITT) basis.||Participants|||Number
101164|NCT00806403|Primary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3|Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.|5-7 days after inclusion|Patient were analyzed on intention to treat (ITT) basis. The per protocol angiography on day 5-7 after inclusion was used for analysis of Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related coronary artery.||participants|||Number
101165|NCT00806403|Secondary|Death||30 days|Analysis was made on intention to treat (ITT) basis.||participants|||Number
101166|NCT00806403|Primary|Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%|ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion|120 minutes after inclusion|Analysis was made on intention to treat(ITT) basis.Patients with electrocardiograms (ECGs) suitable for analysis at inclusion and at 120 minutes therafter were included in the analysis.||participants|||Number
101167|NCT00806390|Primary|Ejection Fraction by MUGA|Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.|Pre and post anthracycline treatment||||||
101168|NCT00806351|Secondary|All-Cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up|Baseline up to 6 weeks post treatment|Safety Population||participants|||Number
101169|NCT00806351|Secondary|Time to Death|Time to death defined as: date of death minus first treatment date plus 1.|Day 1 up to Day 98|Safety Population;subset of participants who died||days||Full Range|Median
101170|NCT00806351|Secondary|Time to First Negative Blood Culture for Candida Species|A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.|Baseline up to Day 56|MITT Population; subset of participants who had a positive blood culture for Candida sp. on Day 1 of treatment. No participant in the Caspofungin treatment arm had a positive blood culture for Candida sp. on Day 1 of treatment.||days||Full Range|Median
101171|NCT00806351|Secondary|Number of Participants With New Infections|Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.|2 and 6 weeks post treatment|MITT Population||participants|||Number
101172|NCT00806351|Secondary|Number of Participants With Recurrence|Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.|2 and 6 weeks post treatment|MITT Population||participants|||Number
101173|NCT00806351|Secondary|Clinical Response at Day 10|Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.|Day 10|MITT Population; Number of participants analyzed (N): participants with evaluable data||participants|||Number
101174|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|6 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point||participants|||Number
101175|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|2 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point||participants|||Number
101176|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 14 up to Day 56|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOT was carried forward programmatically to all subsequent visits.||participants|||Number
101177|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOIVT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 10 up to Day 42|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOIVT was carried forward programmatically to all subsequent visits.||participants|||Number
101178|NCT00806351|Secondary|Global Response at 6-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|6 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.||participants|||Number
101179|NCT00806351|Secondary|Global Response at 2-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|2 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.||participants|||Number
101180|NCT00806351|Secondary|Global Response at End of Treatment (EOT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 14 up to Day 56|MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits.||participants|||Number
101181|NCT00806351|Primary|Global Response at End of Intravenous Treatment (EOIVT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms [s/s] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up [f/u] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to [≥3] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species [sp]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 10 up to Day 42|Modified Intent to Treat (MITT) Population: participants who received at least 1 dose of study medication and had positive culture for Candida sp isolated from cultures obtained from a normally sterile site within 96 hours prior to treatment initiation. A global response of failure at EOIVT was carried forward programmatically to subsequent visits.||participants|||Number
101182|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:~(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent’s proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.~The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|Hour 2 and Hour 6|Intent-to-treat (ITT) ITT population includes participants who completed Periods 1, 2 and 3. Subjects that were discontinued due to adverse events, failed drug/alcohol screens, non-compliance, etc. are not included in this analysis.||scores on a scale||Standard Error|Least Squares Mean
101183|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:~(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent’s proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.~The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|at breath alcohol levels 0.10%, 0.07%, and 0.04%|modified-intent-to-treat (mITT)||scores on a scale||Standard Error|Least Squares Mean
101184|NCT00806195|Secondary|Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination|Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.||Subjects|||Number
101185|NCT00806195|Secondary|Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination|To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.|15 minutes to Day 7|Analysis was done on as treated safety population.||percentages of subjects|||Number
101186|NCT00806195|Secondary|Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period|To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.||Percentages of subjects|||Number
101187|NCT00806195|Primary|Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination|"To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."|15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age|Analysis was done on As Treated Safety Population - Subjects who received at least one study dose and provided postbaseline safety data, and that subjects would be included in the group for the vaccination actually received (i.e., analyzed as treated).||Percentages of subjects|||Number
101189|NCT00806078|Primary|Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)|The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent.|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol||ng·h/mL||Standard Deviation|Mean
101190|NCT00806078|Primary|Maximum Observed Plasma Concentration (Cmax)|The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol||ng per mL||Standard Deviation|Mean
101191|NCT00806026|Secondary|Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12|WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.||Percentage of impairment||Standard Deviation|Mean
101192|NCT00806026|Secondary|Medical Outcomes Study-Short Form 36 (SF-36) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from “0=much worse now” to “4=much better now”. Higher subscale and summary score reflect better health status.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
101193|NCT00806026|Secondary|Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12|RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on Scale||Standard Deviation|Mean
101194|NCT00806026|Secondary|Profile of Mood State (POMS) at Week 12|POMS are participant-rated instrument comprising 6 sub-scales (tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment) and each subscale comprising 5 items, on ‘How you feel right now?’ (Scale: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for vigor-activity. A total score is obtained for each scale. The range of total score is 0 – 100, with higher score indicating more mood disturbance.|Week 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to lack of sufficient knowledge as how to analyze mood data inferentially in RLS population.|||||
101195|NCT00806026|Secondary|Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Participants|||Number
101196|NCT00806026|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.||Units on a Scale||Standard Deviation|Mean
101197|NCT00806026|Secondary|Clinical Global Impressions-Severity (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
101214|NCT00805961|Secondary|To Assess the Overall Survival of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months|||Months||95% Confidence Interval|Number
101198|NCT00806026|Secondary|Severity of Augmentation Symptoms at Week 12|ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants’ answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
101199|NCT00806026|Secondary|Change From Baseline in Limb Pain-VAS at Week 12|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||mm||Standard Error|Least Squares Mean
101200|NCT00806026|Secondary|Limb Pain-Visual Analog Scale (Limb Pain-VAS)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||mm||Standard Deviation|Mean
101201|NCT00806026|Secondary|Change From Baseline in RLS-NDI at Week 12|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant’s previous night’s sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Error|Least Squares Mean
101202|NCT00806026|Secondary|RLS-Next Day Impact (RLS-NDI)|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant’s previous night’s sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
101203|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a scale||Standard Deviation|Mean
101204|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||awakenings||Standard Deviation|Mean
101205|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||hours||Standard Deviation|Mean
101215|NCT00805961|Secondary|To Assess the Toxicity of This Novel Multimodality Regimen||18 months|Information provided in the AEs section|||||
101216|NCT00805961|Primary|Progression-free Survival (PFS)||18 months|||Months||95% Confidence Interval|Median
101537|NCT00803114|Secondary|Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic|"Participants were asked to indicate on a 10 cm line the point at which their perineal pain scored between one end anchored with no pain in my bottom to the other end anchored with the worst pain in my bottom that I can imagine"|by 24 hours postpartum|||scores on a scale||Standard Deviation|Mean
101206|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||minutes||Standard Deviation|Mean
101207|NCT00806026|Secondary|Change From Baseline in SSQ: Subjective WASO at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||minutes||Standard Error|Least Squares Mean
101208|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||minutes||Standard Deviation|Mean
101209|NCT00806026|Primary|Percentage of Participants With Augmentation|Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants’ answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Baseline up to Week 52|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Percentage of participants|||Number
101210|NCT00806026|Primary|Percentage of Participants Responding to Treatment at Week 12|"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of very much improved or much improved."|Week 12|ITT population. Last observation carried forward (LOCF) method was used. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Percentage of participants|||Number
101211|NCT00806026|Primary|Change From Baseline in the RLS Symptom Severity at Week 12|IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Error|Least Squares Mean
101212|NCT00806026|Primary|Restless Legs Syndrome (RLS) Symptom Severity|International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Units on a Scale||Standard Deviation|Mean
101213|NCT00805961|Secondary|To Assess the Complete Response Rate of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months||||||
101217|NCT00805935|Secondary|Participants With Treatment Emergent Adverse Events|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Week 1 to week12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study||Participants|||Number
101218|NCT00805935|Secondary|Number of Live Births Resulting From the In Vitro Fertilization Process|Number of live births resulting from the IVF process|Approximately 10 months|Database was locked prior to most participants giving birth.||Live births|||Number
101219|NCT00805935|Secondary|Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration|Blood tests were sent to a central laboratory to obtain progesterone levels.|approximately day 16|||ng/mL||Standard Deviation|Mean
101220|NCT00805935|Secondary|Human Chorionic Gonadotropin (hCG) Levels at Day 6|Blood tests were sent to a central laboratory to obtain hCG levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||mIU/ml||Standard Deviation|Mean
101221|NCT00805935|Secondary|Estradiol Levels at Day 6|Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||pg/mL||Standard Deviation|Mean
101222|NCT00805935|Secondary|Percentage of Participants With Ongoing Pregnancy at Week 9|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 65|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
101223|NCT00805935|Secondary|Percentage of Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 52|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
101224|NCT00805935|Secondary|Percentage of Participants With Biochemical Pregnancy at Approximately Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of participants|||Number
101225|NCT00805935|Secondary|Number of Embryos Frozen|The number of embryos that were not transferred but instead were frozen for future use.|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Embryos||Standard Deviation|Mean
101226|NCT00805935|Secondary|Number of Embryos Transferred at Three Stages of Development Before Implantation|"The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.~Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape."|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Embryos||Standard Deviation|Mean
101227|NCT00805935|Secondary|Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.|approximately day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Percentage of oocytes retrieved|||Number
101228|NCT00805935|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.|approximately day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Oocytes||Standard Deviation|Mean
101229|NCT00805935|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|approximately day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Follicles||Standard Deviation|Mean
101230|NCT00805935|Primary|Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3|A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|weeks 1-3|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||Participants|||Number
101231|NCT00805870|Primary|Interleukin-6 Measured in Blood|Interleukin-6 is an indirect indicator of muscle inflammation.|6 days|Number of subjects that completed the protocol. Analysis was per protocol||pg/mL||Standard Deviation|Mean
101232|NCT00805870|Primary|Creatine Kinase Activity Measured in Blood|Creatine kinase activity is an indirect indicator of muscle damage.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.||IU/L||Standard Deviation|Mean
101233|NCT00805870|Primary|Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge|The required amount of force applied to the quadriceps to elicit pain or discomfort.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.||lbs||Standard Deviation|Mean
101234|NCT00805870|Primary|Quadriceps Muscle Strength|Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.||lbs||Standard Deviation|Mean
101331|NCT00805285|Primary|Simple Clinical Colitis Disease Activity (SCCAI)|Scores range from 0-19. Higher scores indicated increased disease severity. A score less than 3 is consistent with clinical remission.|0, 2, 4, 6, and 8 weeks||||||
101538|NCT00803114|Secondary|Time to First Request for Analgesia|All participants requested analgesia at least once during their hospitalization|Hours|||hours||Standard Deviation|Mean
101235|NCT00805792|Secondary|Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke|The Trail-making test consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the test: A, in which the targets are all numbers (1,2,3, etc.)and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.).|baseline, 90 days post-stroke|||seconds||Standard Error|Mean
101236|NCT00805792|Secondary|Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke|The mini–mental state examination (MMSE) is a 30-point questionnaire test that is used to screen for cognitive impairment. The questionnaire samples functions including arithmetic, memory and orientation to time and place. Scores range from 0 to 30. Any score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.|baseline, 90 days post-stroke|||units on a scale||Standard Error|Mean
101237|NCT00805792|Secondary|Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke|The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.|baseline, 90 days post-stroke|||units on a scale||Standard Error|Mean
101238|NCT00805792|Secondary|Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 90 days post-stroke|||units on a scale||Standard Error|Mean
101239|NCT00805792|Primary|Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|90 days post-stroke|Intention-to-treat analysis, all treated participants (n=33). Unobserved because of death (n=3) or loss to follow up (N=2) treated as nonresponse.||percentage of participants|||Number
101240|NCT00805766|Secondary|Antibody to TA-650 Determination||Weeks 24 and 40||||||
101241|NCT00805766|Secondary|Serum Concentration of TA-650 at Each Time Point||every 4 weeks for up to 40 weeks||||||
101242|NCT00805766|Secondary|CDAI Change at Each Evaluation Time Point in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|every 4 weeks for up to 40 weeks|||units on a scale||Full Range|Median
101243|NCT00805766|Secondary|CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period||every 4 weeks for up to 40 weeks||||||
101244|NCT00805766|Secondary|CDAI at Each Evaluation Time Point in the Increased Dose Period||every 4 weeks for up to 40 weeks||||||
101245|NCT00805766|Primary|Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Week 0 to Week 8|||units on a scale||95% Confidence Interval|Median
101246|NCT00805740|Secondary|Time to Death|Time to death (days) was assessed as date of death minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.||days||Full Range|Median
101247|NCT00805740|Secondary|Percentage of Participants With All-cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.|Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.||percentage of participants|||Number
101248|NCT00805740|Secondary|Time to Negative Blood Culture|Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|A sub-set of MITT population included only those participants who had a positive blood culture for Candida species at baseline.||days||Full Range|Median
101249|NCT00805740|Secondary|Percentage of Participants With New Infection|New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.||percentage of participants|||Number
101250|NCT00805740|Secondary|Percentage of Participants With Relapse|Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.||percentage of participants|||Number
101251|NCT00805740|Secondary|Percentage of Participants With Clinical Response|A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.|Day 10|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.||percentage of participants||95% Confidence Interval|Number
101252|NCT00805740|Secondary|Percentage of Participants With Response Based on Clinical Cure and Microbiological Success|A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.|EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, ‘n’ signifies those participants who were evaluable for this measure at given time points for each group respectively.||percentage of participants|||Number
101253|NCT00805740|Secondary|Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species. Only participants who completed therapy or who had global response of failure at EOT were evaluable for 2- and 6-week follow-up analysis.||percentage of participants||95% Confidence Interval|Number
101254|NCT00805740|Primary|Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|End of Treatment (Day 14 to Day 42)|Modified Intent-To-Treat (MITT) population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species (sp.).||percentage of participants||95% Confidence Interval|Number
101255|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Half-live of Free Virus|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||Hours||Standard Deviation|Mean
101256|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t) I(t) (1 ) (T I(t))V(t) I(t) where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise allinfected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||Percentage||Standard Deviation|Mean
101257|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||day^-1||Standard Deviation|Mean
101258|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Viral Clearance|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||day^-1||Standard Deviation|Mean
101259|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Estimated Viral Load|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||log10 copies/ml||Standard Deviation|Mean
101260|NCT00805675|Secondary|"Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12"|"HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). HBeAg stands for hepatitis B e antigen. This antigen is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the person is infectious and is able to spread the virus to other people."|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. Note: In this analysis 1 patient HBeAg loss in the Telbivudine 600 mg and Tenofovir 300 mg Treatment Group.||Percentage of Participants|||Number
101261|NCT00805675|Secondary|Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12|Polymerase Chain Reaction (PCR) Negative is defined as HBV DNA levels <25 copies/ml.|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. (1 pat DNA<169 cps/ml)||Percentage of Participants|||Number
101262|NCT00805675|Secondary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 2, Week 4, Week 8|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||log10 copies/mL||Standard Deviation|Mean
101263|NCT00805675|Primary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.||log10 copies/mL||Standard Deviation|Mean
101264|NCT00805545|Primary|Endometritis and Wound Infection|In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby.|Patients were followed from the time of surgery until 6 weeks postpartum.|All 194 patients who received preoperative antibiotics and who completed the study were analyzed. All 197 patients who received post-cord clamping antibiotics and who completed the study were analyzed.||patients infected||95% Confidence Interval|Number
101265|NCT00805493|Primary|Pediatric Anxiety Scale|A standard measure of severity of anxiety over the previous week. The score ranges from a total of 0-25, with 0 being absence of symptoms and impairment, and 25 being marked symptoms and severe impairment. The outcome measure for each participant is the change in PARS, that is, the difference at week 8 compared to baseline (when medication-free).|Weekly for 8 weeks|||units on a scale||Standard Deviation|Mean
101266|NCT00805493|Primary|Clinical Global Impression--Improvement|This is a clinician rated measure that is a standard in pharmacological trials. the scores range from 1 to 8 with 5 being unchanged, 1 being completely recovered and 8 being markedly worse.|8 week trial with the study running for about 4 years.|||units on a scale||Standard Deviation|Mean
101267|NCT00805480|Secondary|Percentage of Participants in Each Investigator Global Assessment (IGA) Category|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set participants, who had values at each week category, were included in the analysis. As such, the population at each week varies from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations.||Percentage of participants|||Number
101268|NCT00805480|Secondary|Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.||Percentage of participants|||Number
101539|NCT00803114|Primary|The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum||24 hours postpartum|Analysis by intention to treat.||participants|||Number
101269|NCT00805480|Secondary|Percentage of Participants With at Least 50% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.||Percentage of participants|||Number
101270|NCT00805480|Primary|Percentage of Participants Who Had Not Relapsed at Any Time in the Trial|This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|PD analysis set participants (AIN457 groups only), who had not yet relapsed were included in the analysis at each time point. As a result, the number of participants at risk for relapse may decrease as the number of weeks on study increases. The PD set included participants who had at least one dose of study medication and no protocol deviations.||Percentage of participants|||Number
101271|NCT00805480|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Baseline, Week 12|Participants from the PD Analysis Set, who had both baseline and week 12 values, were included in the analysis. As such, the population for each treatment group is different from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no protocol deviations.||scores on a scale||Standard Deviation|Mean
101272|NCT00805467|Secondary|HAQ-DI Score|Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.||Scores on a Scale||Standard Deviation|Mean
101273|NCT00805467|Secondary|DAS28-CRP Score|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.||scores on a scale||Standard Deviation|Mean
101274|NCT00805467|Primary|Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).||% of patients|||Number
101275|NCT00804193|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject’s current episode of tinea pedis|6 weeks|||participants|||Number
101276|NCT00804193|Secondary|Proportion of Subjects With Mycological Cure|Potassium hydroxide [KOH] wet mount negative and fungal culture negative|6 weeks|||participants|||Number
101277|NCT00804193|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure|6 weeks|Per protocol population||participants|||Number
101278|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
101279|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
101280|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
101281|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
101282|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
101283|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
101284|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.||cells/mL||Full Range|Median
101285|NCT00805389|Secondary|Gene Expression Signature Related to the Immune Response to the GSK223192A, Fendrix™ and Engerix-B™ Vaccines.|Gene expression signature related to the immune response to the GSK223192A, Fendrix™ and Engerix-B™ vaccines will be measured by microarray/Polymerase Chain Reaction (PCR) array/quantitative PCR, using whole blood. This outcome will be assessed in the first 140 subjects in Subsets 1 and 2 recruited at the Immune Health (IH) Centre in La Louvière, Belgium. Results for this outcome measure will be posted when available.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.||12/2050||||
101286|NCT00805389|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination|A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.||Subjects|||Number
101287|NCT00805389|Secondary|Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs)|AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.||Subjects|||Number
101288|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.||Subjects|||Number
101289|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine.|Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.||Subjects|||Number
101290|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination.|Solicited general symptoms assessed were Fatigue, Fever – oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) –, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
101291|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
101292|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination.|Solicited general symptoms assessed were Fatigue, Fever – oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) –, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.||Subjects|||Number
101293|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.||Subjects|||Number
101294|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.||Subjects|||Number
101573|NCT00802880|Secondary|Correlate Overall Survival With Best Anatomic Response||Completion of follow-up (estimated to be 1 year)|26 patients were not evaluable for this outcome measure for various reasons including unknown survival status, progressive disease prior to cycle 3, no anatomic response noted, and toxicity.||months||95% Confidence Interval|Median
101295|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|post vaccination (up to Day 360).|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
101296|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
101297|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.||Subjects|||Number
101298|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|Post vaccination (up to Day 360)|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
101299|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
101300|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||Subjects|||Number
101301|NCT00805389|Secondary|Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase|Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||cells/mL||Inter-Quartile Range|Median
101302|NCT00805389|Secondary|Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase|Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||cells/mL||Inter-Quartile Range|Median
101591|NCT00802841|Secondary|Event-Free Survival (EFS)|EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
101303|NCT00805389|Secondary|Normalized Levels of Red Blood Cells and Platelets|Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||cells/mL||Inter-Quartile Range|Median
101304|NCT00805389|Secondary|Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||IH normalized ratio||Inter-Quartile Range|Median
101305|NCT00805389|Secondary|Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||IH normalized ratio||Inter-Quartile Range|Median
101306|NCT00805389|Secondary|Normalized Levels of C-reactive Protein (CRP)|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30 and 37.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||IH Center normalized levels||Inter-Quartile Range|Median
101307|NCT00805389|Secondary|Normalized Levels of White Blood Cells (WBC) and of Creatine Phosphokinases (CPK)|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.||IH Center normalized ratio||Inter-Quartile Range|Median
101308|NCT00805389|Secondary|Normalized Levels of C-reactive Protein (CRP)|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||IH Center normlized ratio||Inter-Quartile Range|Median
101309|NCT00805389|Secondary|Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK)|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||IH Center normalized ratio||Inter-Quartile Range|Median
101310|NCT00805389|Secondary|Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum|Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.||pg/mL||Inter-Quartile Range|Median
101311|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells – expressed through tabulation of interquartile range data – was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
101312|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells – expressed through tabulation of interquartile range data – was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 37, 44 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
101313|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 374 and 390|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.||mIU/mL||95% Confidence Interval|Geometric Mean
101314|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||mIU/mL||95% Confidence Interval|Geometric Mean
101315|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||mIU/mL||95% Confidence Interval|Geometric Mean
101316|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD8+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Since T helper cells are all CD4 T cell, no Th1/ Th2 cytokine profile was performed for CD8 T cells.|At Days 0, 14, 30, 44, 60, 180||12/2050||||
101317|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
101318|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
103292|NCT00788710|Secondary|Average Elicited Pain Upon Sitting Over Days 1 to 3|Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 days|Full analysis set population||Score on a scale||Standard Error|Least Squares Mean
101319|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 44, 60 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
101320|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 33, 37, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
101321|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
101322|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells.|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
101323|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
101324|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
101325|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 8 (CD8+) T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
101326|NCT00805389|Primary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.|At Days 0, 14, 30, 44 and 60|Analyses were performed on the According-to-Protocol cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
101327|NCT00805285|Secondary|C Reactive Protein|Higher values indicated increased disease activity|Week 0 and 8||||||
101328|NCT00805285|Secondary|Adverse Events||0, 2, 4, 6, 8, 11, 14, 20, 26, and 52 weeks|||Adverse events|||Number
101329|NCT00805285|Secondary|ACTH Stimulation Test|An increase in cortisol after stimulation by ACTH is normal. Blood cortisol after ACTH stimulation should be greater than 18 - 20 mcg/dL, depending on the dose of cosyntropin used.|Week 16||||||
101330|NCT00805285|Primary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ)|Scores range from 10-70 where higher scores indicated better quality of life.|Week 0 and 8||||||
103293|NCT00788710|Secondary|Average Total Daily Dose of Morphine Over Days 1 to 3||3 days|Full analysis set population||milligrams (mg)||Standard Error|Least Squares Mean
101332|NCT00805194|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 42 months|Treated set- all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.||% of participants|||Number
101333|NCT00805194|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
101334|NCT00805194|Secondary|Quality of Life (QoL)|"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items.~The following were the main points of interest:~Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19).~Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve"|From randomisation until cut-off date 15 February 2013|Randomised set||months||Inter-Quartile Range|Median
101335|NCT00805194|Secondary|Clinical Improvement|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised set||months||Inter-Quartile Range|Median
101336|NCT00805194|Secondary|Change From Baseline in Tumour Size|"Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion.~Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||percentage of change in tumor size in mm||95% Confidence Interval|Mean
101337|NCT00805194|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
101338|NCT00805194|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||% of participants|||Number
101339|NCT00805194|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
101340|NCT00805194|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
101341|NCT00805194|Secondary|Objective Tumour Response|"Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set||% of participants|||Number
101342|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
101343|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set||months||Inter-Quartile Range|Median
101592|NCT00802841|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
101344|NCT00805194|Secondary|Overall Survival (Key Secondary Endpoint)|"Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~A fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been."|From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )|Randomised Set||months||Inter-Quartile Range|Median
101345|NCT00805194|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)|Randomised Set||months||Inter-Quartile Range|Median
101346|NCT00805142|Secondary|Patient’s Global Impression of Change (PGI-C)|PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||participants|||Number
101347|NCT00805142|Secondary|Sleep Questionnaire Regarding the Quality of Sleep|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||participants|||Number
101348|NCT00805142|Secondary|Sleep Questionnaire Regarding Number of Awakenings|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||awakenings||Standard Deviation|Mean
101349|NCT00805142|Secondary|Sleep Questionnaire Regarding Time to Sleep and Total Time Slept|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night.|Pre-dose (Day 1) and Day 20|THe PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||minutes||Standard Deviation|Mean
101350|NCT00805142|Secondary|Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy|The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained.|Baseline up to 7 days after last dose of study treatment|The PPS included all participants enrolled excluding those with a major protocol violation.||participants|||Number
101351|NCT00805142|Secondary|Rescue Doses|The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants.|Day 12, 13, 14, 15, 16, 17, 18 and 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||mg per day||Standard Deviation|Mean
101352|NCT00805142|Secondary|Pain Assessment Using Visual Analog Scale (VAS) Score|Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash.|Baseline and Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Missing values were imputed using last observed carried forward (LOCF) method.||mm||Standard Deviation|Mean
101353|NCT00805142|Secondary|Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale|Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded.|Baseline (Average of Day -1 and Day 0 morning scores), Day 20|The PPS included all participants enrolled excluding those with a major protocol violation.||units on a scale||Standard Deviation|Mean
101354|NCT00805142|Secondary|Percentage of Participants Who Achieve Dose Adjustment|Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period.|Day 3 up to Day 14|The PPS included all participants enrolled excluding those with a major protocol violation.||percentage of participants||95% Confidence Interval|Number
103294|NCT00788710|Primary|Average Pain Intensity at Rest Over Days 1 to 3|Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 Days|Full analysis set population||Score on a scale||Standard Error|Least Squares Mean
101355|NCT00805142|Primary|Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase|Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.|Day 15 up to Day 19|Per protocol set (PPS) included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
101356|NCT00805038|Secondary|Impediments to Successful Intervention||18-24 months||||||
101357|NCT00805038|Primary|Number of Steps Completed in Transplant Process|Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.|18-24 months|ITT analysis. Last observation carried forward for preliminary analyses.||steps per participant||95% Confidence Interval|Mean
101358|NCT00805025|Secondary|Responsiveness of the Respiratory Domain of the QOL-B as Assessed by the Anchor-based Minimal Clinically Important Difference (MCID) Following Categorization of Level of Change Using the Global Rating of Change Questionnaire (GRCQ)|"The anchor-based method measured the participant's perception of change at Day 28 using the GRCQ, which assesses improving/worsening symptoms. Distribution of ratings was categorized as no change (-1 to 1), minimal change (≥ 1.1 to < 3.1 or ≤ -1.1 to > -3.1), moderate change (≥ 3.1 to < 5.1 or ≤ -3.1 to > -5.1) or large change (≥ 5.1, ≤ -5.1). The GRCQ evaluated change in respiratory symptoms on a visual analog scale from -7 (worsening) to +7 (improvement). The following algorithm was used to obtain the mean change:~If the corresponding GRCQ score was in the “no change” group, then change from baseline QOL-B = Observed QOL-B change from baseline score; if > 1, then change from baseline QOL-B score = Observed QOL-B change from baseline score; if < -1, the change from baseline QOL-B score = (-1) * Observed QOL-B change from baseline score.~Then the mean change from baseline of QOL-B respiratory symptoms score of the minimal change category group is the anchor-based MCID."|Day 0 to Day 28|Participants who were evaluable for MCID and had both GRCQ and QOL-B change values at Day 28 (Visit 4) in any GRCQ domain were analyzed.||units on a scale||Standard Deviation|Mean
101359|NCT00805025|Primary|Convergent Validity of the Respiratory Domain of the QOL-B|Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity.|Day -14|Participants were analyzed for respiratory domain score at Day 0 against each of the other variables; those with data for both the respiratory domain score and each variable are reported.||Pearson correlation coefficient|||Number
101360|NCT00805025|Primary|Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)|"Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability.~The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life."|Day -14 to Day 0|Participants who were treated and had any QOL-B measurements at both Screening and Day 0 (Visits 1 and 2) were analyzed.||Intraclass Correlation Coefficient|||Number
101361|NCT00804986|Secondary|Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 12 Weeks|||percentage of participants|||Number
101362|NCT00804986|Secondary|Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint|Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)||millimeters||Standard Error|Least Squares Mean
101363|NCT00804986|Secondary|Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint|DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)||units on a scale||Standard Error|Least Squares Mean
103350|NCT00787566|Secondary|Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS|VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied|24 hours||||||
101364|NCT00804986|Secondary|Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint|Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)||units on a scale||Standard Error|Least Squares Mean
101365|NCT00804986|Secondary|Change in Fasting Weight From Baseline to Week 12 Endpoint|LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
101366|NCT00804986|Secondary|Change in Fasting Lipids From Baseline to Week 12 Endpoint|Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. The last post-baseline measurement was carried forward if the value at week 12 was missing.||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
101367|NCT00804986|Secondary|Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
101368|NCT00804986|Secondary|Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
101369|NCT00804986|Secondary|Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||milligrams per minute per deciliter||95% Confidence Interval|Least Squares Mean
101370|NCT00804986|Secondary|Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint|Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
101371|NCT00804986|Secondary|Total Average Concentration (Cavg) of LY2428757|Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).|4 weeks, 6 weeks, 8 weeks, 10 weeks|All randomized participants||nanograms per milliliter (ng/mL)|||Number
101372|NCT00804986|Secondary|Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study|Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.|baseline through 16 weeks|All randomized participants||participants|||Number
101373|NCT00804986|Secondary|Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint|The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||millimeters (mm)||Standard Error|Least Squares Mean
101374|NCT00804986|Primary|Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint|LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
101692|NCT00800839|Secondary|2-year Progression-Free Survival|Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years|||percentage of participants||95% Confidence Interval|Number
101375|NCT00804843|Primary|Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay|Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol – Free Cholesterol.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were to be included in the analysis. This was not performed due to technical concerns. Instead, the cholesterol content determination, if performed, will use mass spectrometry approach and would be an exploratory objective.|||||
101376|NCT00804843|Primary|Plaque Instability Protein Composite Score|Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.||Score||Standard Deviation|Mean
101377|NCT00804843|Primary|Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis|"Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation (Hot biomarkers) & 25 biomarkers associated with stability (Cold biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 cold genes, and subtracting the average Ct for the 60 hot genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed)."|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.||Cycle threshold (Ct)||Standard Deviation|Mean
101378|NCT00804713|Other Pre-specified|TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results||48-72 hours after adminstration|||participants|||Number
101379|NCT00804713|Other Pre-specified|Battey Skin Test Result|Battey skin test positive results defined as >= 100 mm reaction. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after administration|||participants|||Number
101380|NCT00804713|Other Pre-specified|T-Spot Result|Positive T-Spot results. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours|||participants|||Number
101381|NCT00804713|Secondary|Positive QFT-GIT Result|The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after enrollment|||participants|||Number
101382|NCT00804713|Primary|TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.|"Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.)~The number of 1803 is used here because that is the number for which valid results were available for all 4 tests.~The number presented in each category is the number of participants that had positive results.~We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol."|48-72 hrs post administration|||participants|||Number
101383|NCT00804687|Secondary|Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1|The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.|Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||square centimeter (cm^2)||Standard Deviation|Mean
101384|NCT00804687|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
101403|NCT00804570|Secondary|Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at Week 16 Endpoint|The GSRS is a clinician-administered scale used to assess upper and lower gastrointestinal physical symptoms. 15 items covering domains of abdominal pain, reflux syndrome, indigestion syndrome, diarrhea syndrome, and constipation syndrome were assessed with a 1-week recall period. Total scores range from 0-45. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101385|NCT00804687|Secondary|Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).|2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||units on a scale * hours||Standard Deviation|Mean
101386|NCT00804687|Primary|Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry|The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.|2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|Intent to treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||square centimeter*hour (cm^2*h)||Standard Deviation|Mean
101387|NCT00804648|Secondary|Visual Acuity|The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.|following 3 days of treatment|||number of letters||Standard Deviation|Mean
101388|NCT00804648|Secondary|Conjunctival Staining - Temporal Count|Assessed by investigator using a slit lamp and counting number of spots.|following 3 days of treatment|||number of spots||Standard Deviation|Mean
101389|NCT00804648|Secondary|Conjunctival Staining - Temporal Grade|Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
101390|NCT00804648|Secondary|Conjunctival Staining - Nasal Count|Assessed by investigator using slit lamp and counting number of spots.|following 3 days of treatment|||number of spots||Standard Deviation|Mean
101391|NCT00804648|Secondary|Conjunctival Staining - Nasal Grade|Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
101392|NCT00804648|Secondary|Basic Schirmer's|Schirmer's measures basic tear function. The higher the number, the less dry the eye.|following 3 days of treatment|||mm of moisture||Standard Deviation|Mean
101393|NCT00804648|Secondary|Intraoclular Pressure||following 3 days of treatment|||mm of mercury||Standard Deviation|Mean
101394|NCT00804648|Secondary|Corneal Staining Count|Assessed by the investigator using a slit lamp, counting the number of spots.|following 3 days of treatment|||Number of spots||Standard Deviation|Mean
101395|NCT00804648|Secondary|Corneal Staining Grade|Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
101396|NCT00804648|Secondary|Tear Film Break-up Time||following 3 days of treatment|||Seconds||Standard Deviation|Mean
101397|NCT00804648|Secondary|Conjunctival Hyperemia|Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
101398|NCT00804648|Primary|Stinging on Instillation|Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.|following 3 days of treatment|||Units on a scale||Standard Deviation|Mean
101399|NCT00804609|Secondary|PD (Pharmacodynamic)||72 hours post Cesarean delivery||||||
101400|NCT00804609|Primary|Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)|The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.|a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose|||ng/mL||Standard Deviation|Mean
101401|NCT00804596|Secondary|Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.|1-2 hours|Since each subject provided two blood glucose (BG) meter results, 2x74 (or 148) subject BG test results were possible. For each subject blood sample, a healthcare professional (HCP) provided two BG meter results so that 2x74 (or 148) BG results were possible for HCP test results.||Number of Duplicate Results (n=74x2)|||Number
101402|NCT00804596|Primary|Percentage of Participants Rated as <=3 (Comprehension of Labeling)|"Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:~Successful in performing tasks correctly without assistance~Successful after being referred to user instructions~Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|1-2 hours|per protocol||percentage of participants|||Number
101404|NCT00804570|Secondary|Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint|The revised CIWA-Ar scale measured the severity of alcohol withdrawal by rating 10 signs and symptoms: nausea; tremor; autonomic hyperactivity; anxiety; agitation; tactile, visual, and auditory disturbances; headache; and disorientation. Total scores range from 0-67. Higher scores indicate greater severity of withdrawal.|Baseline through Week 16|Participants who took at least one dose of study drug.||participants|||Number
101405|NCT00804570|Secondary|Change From Baseline in Orthostatic Pulse Rate at Week 16 Endpoint|Orthostatic pulse rate is the pulse rate measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||beats per minute||Standard Error|Least Squares Mean
101406|NCT00804570|Secondary|Change From Baseline in Orthostatic Blood Pressure (BP) at Week 16 Endpoint|Orthostatic BP is the BP measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|||mmHg||Standard Error|Least Squares Mean
101407|NCT00804570|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|Percentage of participants had one or more TEAEs during treatment period. TEAE is a worsening or new occurrence of adverse event during treatment compared to baseline.|Baseline through Week 16|Participants who took at least one dose of study drug.||percentage of participants|||Number
101408|NCT00804570|Secondary|Percentage of Participants Discontinuation Due to Adverse Events (AEs)|Percentage of participants discontinued study due to one or more AEs.|Baseline through Week 16|Participants who took at least one dose of study drug.||percentage of participants|||Number
101409|NCT00804570|Secondary|Change From Baseline in QTc Fridericia's Correction Interval (QTcF) Measured by Electrocardiograms at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
101410|NCT00804570|Secondary|Change From Baseline in Supine Pulse Rate at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||beats per minute (bpm)||Standard Error|Least Squares Mean
101411|NCT00804570|Secondary|Change From Baseline in Supine Blood Pressure (BP) at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
101412|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Volume of Distribution|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.||Liter (L)||Standard Error|Mean
101413|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Clearance|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.||Liter/hour (L/hr)||Standard Error|Mean
101414|NCT00804570|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at Week 16 Endpoint|EWPS is a self-rated work productivity scale that assesses such topics as work hours, work missed, and behaviors and feelings related to the workplace. The EWPS will be completed only by subjects who work outside the home. There are 25 items and total scores range from 0-100. Higher scores indicate poorer productivity. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101415|NCT00804570|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 16 Endpoint|Q-LES-Q-SF is a self-report instrument that assesses the degree of enjoyment and satisfaction in daily life activities. The domains include: social relationships, living or house situation, and physical health. Total scores range from 14-70. Higher scores indicate better quality of life. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101416|NCT00804570|Secondary|Change From Baseline in Thoughts About Abstinence Scale at Week 16 Endpoint|Thoughts About Abstinence Scale was to measure participant's commitment to abstinence. It includes 3 items on a scale of 1-10: own desire to stop drinking (1=no desire to quit); own expectation of success in quitting (1=lowest expectation of success); how difficult to quit and remain abstinent (1=lowest amount of difficulty); and their goal related to alcohol use (scale of 1-7: 1=having no goal, up to total abstinence at 6 [7 was none of 6 above]). Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101417|NCT00804570|Secondary|Change From Baseline in Barratt Impulsivity Scale-11 (BIS-11) Total Score at Week 16 Endpoint|The BIS-11 is a 30-item, self-administered impulsivity scale. Motor, cognitive, and non-planning domains are assessed and a total score is computed. This scale has previously been used in substance-abusing populations. Total scores range from 30-120. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101457|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.||participants|||Number
101418|NCT00804570|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) Total Score at Week 16 Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Participant was asked to rate how much he or she has been bothered by each symptom over the past week. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). Total scores range from 0 to 63. The higher the score, the more severe the anxiety symptoms. LS Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101419|NCT00804570|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score at Week 16 Endpoint|The BDI-II contains 21 items that characterize how the subject was feeling in the past 2 weeks. There is a 4-point scale for each item ranging from 0 to 3 (0=no depression; 3=very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101420|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint|AST is a potential biomarker for LY2196044 efficacy as decreases reflect decreased alcohol consumption. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||ratio||Standard Error|Geometric Mean
101421|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint|Gamma-Glutamyltransferase (GGT) and %CDT will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||ratio||Standard Error|Geometric Mean
101422|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint|GGT and carbohydrate-deficient transferrin (%CDT) will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||ratio||Standard Error|Geometric Mean
101423|NCT00804570|Secondary|Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint|DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. DrInC-2R provides a measurement since the last interview. Total scores range from 0-150, and higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101424|NCT00804570|Secondary|Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint|Cravings will be assessed using the OCDS. The OCDS is a 14-item self-rating instrument. Total scores range from 0-40. Higher scores indicate more obsessive and craving. Least Squares (LS) Mean value was controlled for treatment, site, visit, gender, history, baseline, gender*history, treatment*visit, baseline*visit, gender*treatment, gender*treatment*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||units on a scale||Standard Error|Least Squares Mean
101425|NCT00804570|Secondary|Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||number of drinks/heavy drinking day||Standard Error|Least Squares Mean
101426|NCT00804570|Secondary|Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on the days the participant drank. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||number of drinks/drinking day||Standard Error|Least Squares Mean
101427|NCT00804570|Secondary|Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the percentage of days abstinent. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||percentage of days||Standard Error|Least Squares Mean
101593|NCT00802841|Secondary|Duration of CCyR|Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
101428|NCT00804570|Secondary|Change From Baseline in Drinks Per Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed per day. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.||number of drinks/day||Standard Error|Least Squares Mean
101429|NCT00804570|Primary|Percentage of Heavy Drinking Days at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.||percentage of days||Standard Error|Least Squares Mean
101430|NCT00803959|Secondary|Stress Test at 12 Mos|A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test. The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments.|Screen and 12 months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Of these, only 225 in the UDS arm and 222 in the no UDS had stress test data at 12 months.||percentage of participants|||Number
101431|NCT00803959|Secondary|Patient Satisfaction With Treatment Outcome|A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction.|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101432|NCT00803959|Secondary|Moderate or Severe Severity as Measured by the PGI-S|"The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe]. This measure is the percentage of participants responding to the PGI-S with a 3 corresponding to the moderate category or a 4 corresponding to the severe category at the 12 month visit."|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. One woman was missing PGI-S data in the UDS arm and was excluded leaving n=271 in the UDS arm.||percentage of participants|||Number
101433|NCT00803959|Secondary|Change in Severity as Measured by the PGI-S|The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe]. Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101434|NCT00803959|Secondary|Change in Quality of Life as Measured by the SF-12|The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health. Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200. The larger the positive value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101435|NCT00803959|Secondary|Change in Quality of Life as Measured by the IIQ|Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life. Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101436|NCT00803959|Secondary|Change in MESA Urge Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA urge score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101437|NCT00803959|Secondary|Change in MESA Stress Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA stress score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101438|NCT00803959|Secondary|Change in Severity as Measured by the ISI|Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101439|NCT00803959|Secondary|Change in Bother as Measured by the UDI|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||units on a scale||Standard Deviation|Mean
101440|NCT00803959|Secondary|Patient Global Impression Index|"Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants,~How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage?” Responses are on a 7-point scale from 1 meaning “very much better” to 7 meaning~very much worse.” Values of very much better (1) or much better (2) were considered to have perceived improvement according to this criteria. Values of 3 or greater were not (e.g. a little better, no change, a little worse, much worse or very much worse). This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence."|12 Months|315 women were randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Two were missing PGI-I data in the UDS arm and 4 in the no UDS arm; sample size was 262 in no UDS arm and 270 in the UDS arm.||percentage of participants|||Number
101441|NCT00803959|Secondary|Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial.|Baseline, 12 mos|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.||percentage of participants|||Number
101442|NCT00803959|Primary|"Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and Very Much or Much Better on the Patient Global Impression of Improvement Measure at 12 Mos."|"Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of~“very much better” or “much better” at 12 months."|12 Months|There were 315 women randomized to each of the arms. In the no UDS arm (and UDS arm), 49 (43) did not have primary outcome data, leaving 266 (272) included in the ITT analysis. Of these, 259 (264) were included in the PP analysis with primary outcome data. The PP analysis was the primary analysis because the outcome was a non-inferiority endpoint.||percentage of participants|||Number
101443|NCT00803790|Secondary|Part II : Maximum Concentration (Cmax) of Vitamin D|Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Periods 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.||ng/ml||Standard Deviation|Least Squares Mean
101444|NCT00803790|Primary|Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D|The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Period 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.||ng*hr/mL||Standard Deviation|Least Squares Mean
101445|NCT00803790|Primary|Part 1: Urinary Excretion of Alendronate|Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at –2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.|Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)|220 participants of the 251 enrolled in Part 1 were included in the statistical analysis. 31 participants were excluded: 23 were enrolled but did not complete both study periods and 8 participants had incomplete urine profiles in one or both periods.||μg||Standard Deviation|Least Squares Mean
101458|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Maintenance Phase|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.||participants|||Number
101446|NCT00803777|Secondary|Average Within Replicate Coefficient of Variation CV (Precision)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|1-2 hours|Meter results were used from subject and HCP data that had numeric values for duplicate BG self-tests. One subject data set was not used because subject was given carbohydrate to prevent low blood sugar. Two subjects' meter results contained outliers (NCCLS EP-9A) and one HCP's results had only one replicate result so these sets were not analyzed.||percentage CV|||Number
101447|NCT00803777|Secondary|Number of Participants Rated as <=2 (Labeling Comprehension)|"Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:~Successful in performing tasks correctly without assistance~Successful after study staff prompted participant to review User Guide.~Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)~Subject did not perform task correctly and study staff intervention was required."|1-2 hours|For 2 different subjects, study staff did not rate subject success at 1 task.||participants|||Number
101448|NCT00803777|Secondary|Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies|The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences|1-2 hours|Some subjects >=13 yrs consented to provide larger capillary samples for YSI glucose analysis. One subject's sample was insufficient to run the YSI analysis. Another subject’s results were not useable as the subject was given carbohydrate to prevent low blood sugar. Duplicate subject BG results provided 158 possible data points.||Number of BG results in zone (n=79x2)|||Number
101449|NCT00803777|Primary|Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results|Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.|1-2 hours|One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.||number of Subject BGM Results (n=146x2)|||Number
101450|NCT00803777|Primary|Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated.|1-2 hours|Some subjects >=13 years old consented to provide larger capillary samples for YSI glucose analysis. Subjects and HCPs provided duplicate results, but one subject's HCP provided only one glucose result. One subject sample was too small to run the YSI analysis; another subject was given carbohydrate to prevent low blood sugar (no results obtained)||number of capillary results (n=79x2)|||Number
101451|NCT00803738|Secondary|Proportion of Subjects With Clinical Cure|"A subject was considered a clinical cure if all of the following were satisfied:~All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.~Total signs and symptoms did not worsen at any time following completion of the study treatment.~Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.~The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.~The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products"|Visit 3: Day 22-31|per protocol population||participants|||Number
101452|NCT00803738|Secondary|Proportion of Subjects With Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.|Visit 3: Day 22-31|Per protocol population||participants|||Number
101453|NCT00803738|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Cure|The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.|Visit 3: Day 22-31|Per Protocol (PP) population||participants|||Number
101454|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.||participants|||Number
101455|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Maintenance Phase|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.||participants|||Number
101456|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.||participants|||Number
101594|NCT00802841|Secondary|Time to CCyR|Time to CCyR was defined as time from date of randomization to date of first documented CCyR.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
101459|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.||participants|||Number
101460|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
101461|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
101462|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
101463|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
101464|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
101465|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
101466|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
101467|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase||mg/dL||95% Confidence Interval|Least Squares Mean
101507|NCT00803413|Primary|Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)|Patients were asked to indicate their perception about their LBP intensity with a cross on a line without marks, ranging from 1 (very light pain) through 10 (very strong pain)|6 months|||milimeters||Standard Deviation|Mean
101468|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
101469|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||pg/mL||95% Confidence Interval|Least Squares Mean
101470|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||percent change||95% Confidence Interval|Least Squares Mean
101471|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase||pg/mL||95% Confidence Interval|Least Squares Mean
101472|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phases||participants|||Number
101473|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phases||participants|||Number
101474|NCT00803712|Secondary|Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases||participants|||Number
101475|NCT00803712|Secondary|Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases||participants|||Number
101476|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 48-52||participants|||Number
101477|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 22-26||participants|||Number
101478|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 48-52||participants|||Number
101479|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 22-26||participants|||Number
101480|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52||participants|||Number
101481|NCT00803712|Secondary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52||participants|||Number
101482|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 22-26||participants|||Number
101483|NCT00803712|Primary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all participants who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for participants without an iPTH value during weeks 22-26||participants|||Number
101484|NCT00803686|Secondary|AUCInhibition=Hours*%P|The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.|12 Hours|||hours*%P||Standard Deviation|Mean
101485|NCT00803686|Secondary|Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women|See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition).|12 hours|Data from Part 1 (crossover Periods 1 and 2) were pooled to give CTx-1 mean data for the oral rsCT tablet group (n = 12) and for the oral placebo group n = 12). Part 2, open-label, non-crossover, compared the CTx-1 results after oral rsCT (n = 5) with those after Fortical(n = 4. The % inhibition is reported first.||Hours||Standard Deviation|Mean
101508|NCT00803413|Secondary|Spine Flexibility (3rd Fingertip to Floor – 3FF).|Patients in up-right position with joined feet and stretched out arms were asked to bend the spine as much as possible without bending the knees; the least achieved distance between the 3rd fingertip and the floor was measured in centimeters with a proper rule.|6 months|||centimeters||Standard Deviation|Mean
102543|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Quantification Over Time|Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time|from day 1 and up to 4 weeks|FAS||percentage of participants|||Number
101486|NCT00803686|Primary|Pharmacodynamic Effect of Oral Calcitonin|C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc|12 hr|Not applicable. All participants who received treatment were included.||percentage of time-matched placebo respo||Standard Deviation|Mean
101487|NCT00803647|Secondary|Recurrence-free Survival (RFS). Time From Study Entry Until First Recurrence.||2 years|Patients with R0 resection||months||95% Confidence Interval|Median
101488|NCT00803647|Secondary|Objective Clinical Response Rate (cRR). Measureable Lesions That Can be Accurately Measured in at Least One Dimension With Conventional Radiologic Techniques or Spiral CT.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by PET/CT, CT scan, MRI or spiral CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective clinical Response Rate (cRR) = CR + PR during the 3 preoperative cycles, among the treated patients.|8 months|||percentage of participants||95% Confidence Interval|Number
101489|NCT00803647|Secondary|Overall Survival (OS). Time From Study Entry Until Death From Any Cause.||3 years||||||
101490|NCT00803647|Primary|Reported Adverse Events.|19 participants experienced at least one adverse event. There were a total of 95 adverse events reported. (Note: multiple occurrences of the same adverse event in one individual are counted only once.) Refer to the Adverse Events section for specifics. The Other Adverse Events section lists only those events occurring above 5% frequency.|8 months|||adverse events|||Number
101491|NCT00803647|Primary|The Percentage of Patients Who Had a Curative (R0) Liver Metastasectomy Following Protocol Treatment, i.e., Metastatic Disease That Can be Completely Resected and/or Ablated With no Postoperative Evidence of Residual Malignant Disease (R0 Resection).||8 months|All 20 patients were included in this outcome measure.||percentage of participants||95% Confidence Interval|Number
101492|NCT00803634|Primary|Percentage to First Achieve Initial Prespecified SBP Target Range [≥20 mm Hg and ≤40 mm Hg Apart] and 15% Reduction From Baseline Within First 30 Minutes|Analysis of the percentage of patients achieving both components of this composite endpoint (attainment of the initial prespecified SBP target range and a 15% reduction in SBP from baseline) was calculated within each treatment group using the number of mITT patients achieving the SBP reduction goal divided by the number of mITT patients, and multiplied by 100.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
101493|NCT00803634|Secondary|Number of Patients That Require Intubation During Study Drug Administration up to 96 Hours|The number of patients requiring intubation was calculated based on the total number of mITT patients.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Patients|||Number
101494|NCT00803634|Secondary|Percentage of Patients With at Least One Episode of SBP < 90 mm Hg During Study Drug Administration (up to 96 Hours)|The percent of patients with at least one episode of SBP <90 mm Hg was calculated as the number of mITT patients who had at least one episode of SBP<90 mm Hg during study drug administration up to 96 hours divided by mITT patients, and multiplied by 100 for each treatment group.|Initiation through termination of study drug (up to 96 hours)|Safety population: All randomized and eligible patients who were dosed with study drug.||Percentage of patients||95% Confidence Interval|Number
101495|NCT00803634|Secondary|Percentage of Patients Who Received Any Alternative IV Antihypertensive Drug at Any Time During Study Drug Treatment|The percentage of patients who received any alternative IV antihypertensive drug at any time during the study drug treatment period (up to 96 hours) was calculated using mITT patients within each treatment group.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
101496|NCT00803634|Secondary|Time to Use Other IV Antihypertensives During the Study Drug Administration|The length of time to use other IV antihypertensive agents was defined as the duration in hours from the initiation of study drug through the time when any other concomitant IV antihypertensive agent was administered, thus, representing the time period without use of any other concomitant IV antihypertensive agent. Median time to use other IV antihypertensive agents was obtained using Kaplan-Meier method. If a patient did not receive any concomitant IV antihypertensive during the 96-hour treatment period, this patient was considered censored at 96 hours. If study drug was stopped less than 96 hours and the patient has no concomitant IV antihypertensive agent, the patient was considered censored when study drug was stopped.|Initiation of study drug through any other concomitant IV antihypertensive agent administered, up to 96 hours|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Hours||95% Confidence Interval|Median
101522|NCT00803283|Secondary|Patient's Global Assessment on Effectiveness|Participants will evaluate effectiveness by providing rating on the question “‘what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase” using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101497|NCT00803634|Secondary|Change From Baseline in Dyspnea (Measured By VAS) at Each Time Point|A validated visual analog scale (VAS) with a horizontal ruler showing increments from 0 to 100 mm with 0 = Best and 100 = Worst was used. The test was asked from the patient's perspective and had to be administered with patient sitting. Relative change in VAS from baseline is the value at each time point minus the baseline value. Relative change from baseline was summarized descriptively (with associated two-tailed 95% CIs of the mean values) at 15, 30 and 45 minutes and at 1, 2, 3 hours and 12 hours, and 1 hour post termination of study drug treatment.|Baseline (immediately prior to study drug administration) through 1 hour after study drug termination|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||millimeters (mm)||Standard Deviation|Mean
101498|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the entire study drug treatment period (up to 96 hours) was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
101499|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the first 30 minutes was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
101500|NCT00803634|Secondary|SBP Area Under the Curve (AUC) Outside Prespecified Target Range|The magnitude and duration of SBP excursions was calculated as the area under the curve (AUC) for each patient, using the trapezoidal rule, related to time (in minutes) that each patient’s SBP was outside the target range. AUC was determined based on data collected from the initiation of study medication through the end of monotherapy treatment up to 96 hours, normalized per hour, and expressed as mmHg × minute/hour.|Initiation of study drug through end of monotherapy (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||mm Hg x min/h||Standard Deviation|Mean
101501|NCT00803634|Secondary|Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes|The percentage of patients reaching this endpoint was calculated within each treatment group using the number of mITT patients reaching the endpoint divided by the number of mITT patients, and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Percentage of patients||95% Confidence Interval|Number
101502|NCT00803634|Primary|Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes|Time to first achieve the initial pre-specified systolic blood pressure (SBP) target range and a 15% SBP reduction from baseline is the time in minutes between the initiation of study medication and the time the patient first achieved both components. Median time was estimated using Kaplan Meier method. 95% two-sided confidence interval of the median time is from 'Simon and Lee, 1982'. If patients did not reach both components within 30 minutes from the initial treatment with study medication, or another antihypertensive agent was administered, the patient was censored at 30 minutes or the time when another antihypertensive agent is given, whichever came first.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF||Minutes||95% Confidence Interval|Median
101503|NCT00803595|Secondary|Time for Body Temperature to Return to Normal|Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored.|15 days|||hours||95% Confidence Interval|Median
101504|NCT00803595|Primary|Time to Alleviation of Influenza Illness|The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were “absent” or “mild.” Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored.|15 days|Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data.||hours||95% Confidence Interval|Median
101505|NCT00803517|Secondary|Best Corrected Visual Acuity|Best-corrected visual acuities were obtained with Snellen charts. Snellen’s visual acuity was converted logarithm of the minimum angle of resolution (logMAR) for statistical analysis.|baseline, 1 month, 3 months, 6 months|||logMAR||Standard Deviation|Mean
101506|NCT00803517|Primary|Multifocal Electroretinogram Amplitudes|"Amplitude at first annular ring at multifocal electroretinogram RETIscan (Roland Consult, Wiesbaden, Germany) is used for multifocal retinogram.~The recording protocol was chosen according to the International Society for Clinical Electro-physiology of Vision (ISCEV) guidelines."|baseline, 1 month, 3 months, 6 months|||microvolts||Standard Deviation|Mean
101535|NCT00803114|Secondary|Side Effects|Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum|at 24 hours postpartum||||||
101509|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)|The Clinical Global Impression Improvement Scale is a 7 point ordinal scale that assesses how much the patient's illness has improved or worsened relative to a baseline state before the intervention. Rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline and 12 weeks|For this outcome the baseline number of participants is zero as at the first visit patients have not received any treatment yet, thus they cannot be assessed with a scale that measures improvement at their first visit. This scale will only be applied along weeks 2, 4, 8, and 12, after patients have received their corresponding treatments.||Units on a scale||Standard Deviation|Mean
101510|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)|The Clinical Global Impression Severity scale is a 7 point ordinal scale that rates the severity of the patient's illness, assessing on the severity of a patient’s mental illness. It ranges from 1 to 7 (1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; 7, extremely ill).|Baseline and 12 weeks|||Units on a scale||Standard Deviation|Mean
101511|NCT00803400|Primary|Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a test that consists of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|Baseline and 12 weeks|||Units on a scale||Standard Deviation|Mean
101512|NCT00803361|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
101513|NCT00803361|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
101514|NCT00803361|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.|Baseline, Week 15|Participants with a baseline and at least one post-baseline value.||Units on a scale||Standard Deviation|Mean
101515|NCT00803361|Secondary|Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
101516|NCT00803361|Secondary|Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Week 15|Participants with at least one post-baseline result within each treatment group.||Units on a Scale||Standard Deviation|Mean
101517|NCT00803361|Secondary|Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a scale||Standard Deviation|Mean
101518|NCT00803361|Primary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.||Units on a scale||Standard Deviation|Mean
101519|NCT00803283|Secondary|Mean Total Daily Dose (TDD) of Study Medication|Mean total daily dose of study medication taken during study will be recorded by participants.|Baseline up to day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101520|NCT00803283|Secondary|Number of Times the Pain Medication Required for Breakthrough Pain|The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.|Baseline up to Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101521|NCT00803283|Secondary|Investigator's Global Assessment on Effectiveness|Investigator will evaluate effectiveness by providing rating on the question “‘what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase” using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
102544|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Detection Over Time|Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time|from day 1 and up to 4 weeks|FAS||percentage of participants|||Number
101523|NCT00803283|Secondary|"BPI Questionnaire Item Pain Interference Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Interference will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101524|NCT00803283|Secondary|"BPI Questionnaire Item Pain Relief Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Relief will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101525|NCT00803283|Secondary|"BPI Questionnaire Item Pain Intensity Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Intensity will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101526|NCT00803283|Secondary|"BPI Questionnaire Item 6 How Much Pain You Have Right Now Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 6 how much pain you have right now will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101527|NCT00803283|Primary|"BPI Questionnaire Item 3 Worst Pain Score at Day 28"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101528|NCT00803283|Primary|"Brief Pain Inventory (BPI) Questionnaire Item 3 Worst Pain Score at Day 14"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 14|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.|||||
101529|NCT00803270|Secondary|Optimal Outcome of Treatment at 3 Months|"Composite measure defined as much better or very much better om PGI-I and normal or mild on PGI-S. PGI-I is a single item: Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment with responses ranging from 1=Very much better to 7=Very much worse. PGI-S is a single items: Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1=Normal to 4=Severe."|3 months|Participants who attended 3 month follow-up visit||participants|||Number
101530|NCT00803270|Primary|Optimal Outcome of Treatment at 6 Months|"Composite measure defined as much better or very much better on Patient Global Impression of Improvement (PGI-I) and normal or mild on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment with responses ranging from 1= Very much better to 7= Very much worse. The PGI-S is a single item:; Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1 = Normal to 4 Severe."|6 Months|Participants who attended 6 month follow-up visit||participants|||Number
101531|NCT00803244|Post-Hoc|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient’s daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.~The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).~The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Combined Score during the pollen period while on treatment.||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
101532|NCT00803244|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.~Participants assessed daily, during the pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment.||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
101533|NCT00803179|Secondary|Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy||14 months||||||
101534|NCT00803179|Primary|Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy||14 months||||||
101540|NCT00803101|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. TEAEs were defined as adverse events that developed or worsened following exposure to investigational medicinal product. Treatment-related TEAEs were events whose relationship to study treatment was related, probably related, or possibly related in the opinion of the investigator. Treatment emergent adverse events with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent serious adverse events (SAEs).|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs|The Intention-to-Treat Safety (ITT-S) population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.||participants|||Number
101541|NCT00803101|Secondary|Percentage of Participants Who Received Red Blood Cells|Red blood cells were PRBCs and whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
101542|NCT00803101|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
101543|NCT00803101|Secondary|Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood|The total units of transfused PRBCs or whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||units of PRBCs or whole blood||Standard Deviation|Mean
101544|NCT00803101|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From pre-infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of normal||Standard Deviation|Mean
101545|NCT00803101|Primary|Percentage of Participants Who Had a Rapid Decrease of the INR|A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after the end of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
101546|NCT00803101|Primary|Percentage of Participants Achieving Hemostatic Efficacy During Surgery|"Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of excellent or good, and 'non-effective' was a hemostatic efficacy rating of poor/none."|From the start of infusion until the end of surgery|The Intention-to-Treat Efficacy ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
101547|NCT00803062|Other Pre-specified|Prevalence of Active Smoking|An estimate of the prevalence of active smoking will be calculated. Will be assessed for associations with progression and/or death.|Up to 5 years||||||
101548|NCT00803062|Other Pre-specified|Number of CTCs|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
101549|NCT00803062|Other Pre-specified|Levels of Tumor Measures of Angiogenesis|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
101550|NCT00803062|Other Pre-specified|Levels of Cell-free DNA in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
101551|NCT00803062|Other Pre-specified|Levels of Angiogenesis Markers in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years||||||
101552|NCT00803062|Other Pre-specified|Health-related Quality of Life|Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.|Up to 9 months after course 1||||||
101553|NCT00803062|Other Pre-specified|Extent of Nicotine Dependence|Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.|Up to 5 years||||||
101554|NCT00803062|Primary|Incidence of Adverse Events Assessed by National Cancer Institute CTCAE Version 3.0.|The frequency and severity of adverse events will be determined. Defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment|Up to 30 days after completion of study treatment||||||
101555|NCT00803062|Primary|Tumor Response|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.|Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.|All randomized patients.||percentage of participants||95% Confidence Interval|Number
101556|NCT00803062|Primary|Progression-free Survival|"Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)|All randomized patients.||months||95% Confidence Interval|Median
101557|NCT00803062|Primary|Overall Survival|The observed length of life from randomization into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|All randomized patients.||months||95% Confidence Interval|Median
101558|NCT00803049|Secondary|Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization|BOD was assessed by cerebral MRI and defined as the total volume of all abnormal brain tissue (calculated as the sum of the total volume of T2-lesion component and T1-hypointense lesion component).|Baseline, Week 192|ITT (LTS6050 population). Number of participants analyzed=participants with available data for this outcome measure.||millilitres (ml)||Standard Deviation|Mean
101559|NCT00803049|Secondary|Annualized MS Relapse Rate (ARR): Poisson Regression Estimates|"ARR was obtained from total number of confirmed relapses that occurred during treatment period divided by sum of treatment durations in LTS6050 study only. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever was to be confirmed by an increase in EDSS score or Functional System (FS) scores. EDSS: an ordinal scale qualifies disability. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). FSS: to assess the neurological function. Total score range: 0 (normal) - 6(worse), higher scores = worse neurological function. To account for the different treatment duration among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Up to 8 years since LTS6050 randomization|ITT(LTS6050) population: all participants who were randomized in the LTS6050 study and had at least 1-day IMP exposure during the LTS6050 study.||relapses per participant-year||95% Confidence Interval|Number
101560|NCT00803049|Secondary|Percentage of Participants Free of Sustained Disability Progression (DP)|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks and 24 weeks. EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicates worse neurological function. Percentage of participants who were considered as free of disability progression confirmed after 12 week sustained progression and 24 week sustained progression were reported. Analysis for this outcome measure was performed on combined data of EFC6049 and LTS6050 study, as pre-specified in protocol.|Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049 [NCT00134563] + LTS6050) population.||percentage of participants|||Number
101574|NCT00802880|Secondary|Correlate Time to Progression With Best Metabolic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.||months||95% Confidence Interval|Median
102088|NCT00796926|Primary|Visual Analog Score (VAS)|Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum|6 weeks|intention to treat||scores on a scale||Standard Deviation|Mean
101561|NCT00803049|Secondary|Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 24 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). Probability of DP at 24 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.||Probability||95% Confidence Interval|Number
101562|NCT00803049|Secondary|Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP defined as sustained increase of at least 1 point from baseline (EFC6049) expanded disability status scale (EDSS) score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to Multiple Sclerosis [MS]). Probability of DP at 12 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.||Probability||95% Confidence Interval|Number
101563|NCT00803049|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.|Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks|Safety population: all participants randomized in the LTS6050 study and exposed to IMP during the LTS6050 study treatment period, regardless of the amount of treatment administered. The safety analysis was conducted as the treatment received.||percentage of participants|||Number
101564|NCT00803023|Secondary|Tolerability Assessed by Adverse Events||4 weeks||||||
101565|NCT00803023|Primary|Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects||4 weeks|||participants|||Number
101566|NCT00803010|Secondary|2 Year Post Transplant Overall Survival (OS) Rate|Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to death from any cause .|2 years|All participants who received treatment||percentage of participants||95% Confidence Interval|Number
101567|NCT00803010|Secondary|Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)|Absolute numbers of Treg at designated time points according to study arm. MTX = methotrexate/tacrolimus-treated patients; SIR = sirolimus/tacrolimus-treated patients; Treg absolute number units = number of cells/microL. A two-sided Wilcoxon's rank-sum test was employed to test differences in percent Treg (% Treg/total CD4+ cells).|30 days and 90 days|||Cells/MicroL||95% Confidence Interval|Median
101568|NCT00803010|Primary|Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant|"Incidence of acute graft versus host disease grades 2-3 according to the Common Toxicity Criteria (CTC) version 3.~Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). Clinical evidence of acute GVHD was recorded per standard grading scheme.~Acute GVHD classified as the following:~classic acute GVHD - onset within 100 days after transplant~persistent – acute GVHD with onset prior to day 100 and without resolution beyond day 100~recurrent – acute GVHD recurrent after prior episode of acute GVHD~late acute GVHD – syndrome consistent with acute GVHD, without features of chronic GVHD, with onset occurring beyond 100 days"|100 Days Post Transplant|All participants who received treatment||percentage of participants||95% Confidence Interval|Number
101569|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 9 Months|||units on a scale||Standard Deviation|Mean
101570|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 6 Months|||units on a scale||Standard Deviation|Mean
101571|NCT00802997|Primary|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
101572|NCT00802880|Secondary|Correlate Overall Survival With Best Metabolic Response||Completion of follow-up (estimated to be 1 year)|28 patients were not evaluable for this outcome measure due to various reason such as progressive disease prior to cycle 3, unknown survival status, no target lesion on PET scan, and toxicity.||months||95% Confidence Interval|Median
101590|NCT00802841|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to the date of the death.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Months||95% Confidence Interval|Median
101575|NCT00802880|Secondary|Correlate the Time to Progression With Best Anatomic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no anatomic response recorded.||months||95% Confidence Interval|Median
101576|NCT00802880|Secondary|Overall Survival||Until completion of follow-up or patient death (estimated to be 1 year)|One patient with invalid time or censoring value was not included.||months||95% Confidence Interval|Median
101577|NCT00802880|Secondary|Time to Progression (TTP)|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Until completion of follow-up (estimated to be 1 year)|10 patient observations with invalid time or censoring values were not included.||months||95% Confidence Interval|Median
101578|NCT00802880|Secondary|Overall Disease Control Rate||12 months|Only 6 patients were evaluable for response at the end of 12 cycles.||participants|||Number
101579|NCT00802880|Secondary|Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate||After completion of 3 cycles|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.||participants|||Number
101580|NCT00802880|Secondary|Overall Tumor Metabolic Response|"Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions.~Partial metabolic response (PMR)~Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.~Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within >50% of the lesions. No unequivocal new lesions.~Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD.~Progressive metabolic disease (PMD):~Unequivocal development of one more new metabolically active lesions~Target lesion: 20% or greater increase in maximum SUV from baseline.~Non-target lesions: unequivocal increase in FDG activity"|After completion of 3 cycles|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.||participants|||Number
101581|NCT00802880|Secondary|Comparison of the SUV at up to 3 Tumor Sites||Baseline and after every three cycles of treatment (up to 1 year)|The lower confidence limit is 85% and the upper confidence limit is 95%. 51 patients evaluable at baseline, 50 patients evaluable at end of cycle 3, 20 patients evaluable at end of cycle 6, 7 patients evaluable at end of cycle 9, and 5 patients evaluable at end of cycle 12.||standard uptake value||95% Confidence Interval|Mean
101582|NCT00802880|Secondary|Rate of Nausea/Emesis (Any Grade)|Approximately 18 weeks|Completion of 6 cycles of treatment (18 weeks)|||percentage of participants|||Number
101583|NCT00802880|Secondary|Rate of Neutropenia (Grade 3/4)|"Grade 3 neutropenia = absolute neutrophil count of <1000 – 500/mm^3~Grade 4 neutropenia = absolute neutrophil count of <500/mm^3"|Completion of 6 cycles of treatment (18 weeks)|||percentage of participants|||Number
101584|NCT00802880|Primary|Best Anatomical Tumor Response|"Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker~Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal~Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal~Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions"|After completion of 3 cycles|3 patients failed to complete 3 cycles of treatment due to toxicity. 22 patients failed to complete 3 cycles of treatment due to progressive disease. 1 patient only had PET scan.||participants|||Number
101585|NCT00802867|Primary|Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®|"Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.~Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash."|0 to 3 days post-dose 5 vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population.||Percentage of Participants|||Number
101586|NCT00802867|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose||Pre-dose 5 and Day 28 to 48 Post-dose 5|The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.||Titers||95% Confidence Interval|Geometric Mean
101587|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose|Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination|Day 28 to 48 Post-dose 5|The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.||Percentage of Participants|||Number
101588|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose|Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5.|Day 28 to 48 Post-dose 5|The anti-Pertussis Booster response was evaluated in a subset of the per-protocol population for immunogenicity.||Percentage of participants|||Number
101589|NCT00802867|Other Pre-specified|Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.|"Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).~Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer."|Day 28 to 48 Post-dose 5|The vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity.||Percentage of Participants|||Number
101595|NCT00802841|Secondary|Percentage of Participants With CCyr|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Percentage of participants|||Number
101596|NCT00802841|Secondary|Percentage of Participants With Major Molecular Response (MMR)|MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS).|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Percentage of participants|||Number
101597|NCT00802841|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR)|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|6 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.||Percentage of participants|||Number
101598|NCT00802737|Secondary|Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4)|Cmax is defined as the maximum concentration of drug in plasma samples (collected at the end of the infusion). Ctrough is defined as the concentration of drug in plasma samples at the end of a dosing interval (collected directly before next administration). Ctrough before the first infusion represents residual ofatumumab from participation in Study Hx-CD20-406.|Visit 2 (Week 0) and Visit 14 (Month 4)|FAS. Data are provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Milligrams per liter (mg/L)||95% Confidence Interval|Geometric Mean
101599|NCT00802737|Secondary|Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics|The data collected for this analysis are reported in the overall SAEs of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS|||||
101600|NCT00802737|Secondary|Number of Participants With the Indicated Major Infections|The data collected for this analysis are reported in the overall Serious Adverse Events (SAEs) of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS|||||
101601|NCT00802737|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS||participants|||Number
101602|NCT00802737|Secondary|Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of Screening and Post Ofatumumab|HAHAs are indicators of immunogenicity to ofatumumab. HAHA levels were assessed for each participant at the end of participation in the study (at their last visit). A positive HAHA status indicates a positive enzyme-linked immunosorbent assay (ELISA) result, an inconclusive status indicates a negative ELISA result at ofatumumab concentration above the threshold at which ofatumumab may interfere with the assay, and a negative status indicates a negative ELISA result at ofatumumab concentration below the threshold.|Screening and post ofatumumab (up to Study Month 32)|"FAS. During the study, samples were to be taken at the last visit; however, this may not have been possible, such as in cases of death, or when the visit was not obvious as the last visit. Therefore, some samples were not available or were not collected."||participants|||Number
101603|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 24|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 24. Percent change was calculated as (Month 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 24|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 24. Only participants with a baseline value and a post-baseline value at Month 24 were included in the calculation.||Percent change in tumor size||Full Range|Median
101604|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 12|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 12. Percent change was calculated as (Month 12 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 12|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 12. Only participants with a baseline value and a post-baseline value at Month 12 were included in the calculation.||Percent change in tumor size||Full Range|Median
101605|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4|Reduction in tumor size was measured as the percent change in the sum of the products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24. Percent change was calculated as (Week 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 4|FAS. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 4. Only participants with a baseline value and a post-baseline value at Month 4 were included in the calculation.||Percent change in tumor size||Full Range|Median
101606|NCT00802737|Secondary|Overall Survival (OS)|OS is defined as the time from allocation to death.|Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)|FAS||months||95% Confidence Interval|Median
101639|NCT00802360|Secondary|Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately week 7|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer||participants|||Number
102089|NCT00796822|Secondary|Safety and Tolerability||Measured at Weeks 4 and 8||||||
101607|NCT00802737|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)|FAS||months||95% Confidence Interval|Median
101608|NCT00802737|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression (prog.)/death. Prog. events are defined by well-documented and verifiable data; other data are censored. If the par. had prog. between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no prog. at the end of the trial, treatment discontinuation for undocumented prog./toxicity/other reason, new anti-cancer treatment, and death/prog. after >=2 missed visits in a row, the endpoint was censored. Clinical prog. is not considered as a prog. endpoint.|Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)|FAS||months||95% Confidence Interval|Median
101609|NCT00802737|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|From the time of the initial response until progression or death (average of 14.1 study months)|FAS||months||95% Confidence Interval|Median
101610|NCT00802737|Primary|Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits >=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, <30% lymphocytes (LC), no lymphoid nodule; PR: >=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0/Visit 2) until Week 52|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Some participants were not evaluable (NE) due to participant withdraw, refusal, non-trial drug-related adverse events, and death.||participants|||Number
101611|NCT00802685|Secondary|Number of Participants on Oxygen at 36 Weeks Postmenstrual Age||at 36 weeks postmenstrual age|||participants|||Number
101612|NCT00802685|Primary|Days Spent on Supplemental Oxygen During the First 28 Days.||28 days of life|The number of participants for analysis was determined from all subjects who completed the study intervention at 28 days of age and had complete data on the primary endpoint of oxygen days during the first 28 days. Analysis was done on intention to treat basis.||days||Full Range|Median
101613|NCT00802672|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject’s current episode of tinea pedis|6 weeks|per protocol population||participants|||Number
101614|NCT00802672|Secondary|Proportion of Subjects With Mycological Cure|Mycological Cure (KOH wet mount negative and fungal culture negative|6 weeks|per protocol population||participants|||Number
101615|NCT00802672|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success|6 weeks|Per protocol population||participants|||Number
101616|NCT00802659|Secondary|Quality of Life|"As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)~Participant can chose on a scale of 0-4 with 0=not at all and 4=very much."|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
101617|NCT00802659|Secondary|Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.||4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
101618|NCT00802659|Secondary|Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.||4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
101619|NCT00802659|Secondary|Duration of Pain Control for Each Dose Level.|A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
101620|NCT00802659|Primary|Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field|"Optimal dose~the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications~the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first"|4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.|||||
101621|NCT00802633|Secondary|Operating Room Time in Minutes||Intraoperative time|||minutes||Standard Deviation|Mean
101622|NCT00802633|Primary|Estimated Blood Loss||Perioperative|||milliliters||Standard Deviation|Mean
101640|NCT00802360|Secondary|Participants With Biochemical Pregnancy at Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer||participants|||Number
101623|NCT00802529|Secondary|Change in Speech Discrimination|"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.~Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear – bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear – 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score."|Baseline, 1,2,6,12 and 24months after initial treatment|||Percentage correct||Standard Deviation|Mean
101624|NCT00802529|Secondary|Change in Hearing|Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.|Baseline, 1,2,6,12,18 and 24months after initial treatment|||dB||Standard Deviation|Mean
101625|NCT00802529|Primary|Vertigo Attacks|The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).|6month pre-enrollment baseline, 18-24 months after initial treatment|Intention-to-treat||Vertigo Attacks||Standard Deviation|Mean
101626|NCT00802503|Secondary|Days in Hospital|hospital length of stay|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||days in hospital||95% Confidence Interval|Mean
101627|NCT00802503|Secondary|Protein Delivery During the Intervention Period From Day 4 to Day 8|Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||percentage of protein target||Standard Deviation|Mean
101628|NCT00802503|Secondary|ICU Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||participants|||Number
101629|NCT00802503|Secondary|Days in ICU|Days in ICU|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||days in ICU||95% Confidence Interval|Mean
101630|NCT00802503|Secondary|General Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||participants|||Number
101631|NCT00802503|Secondary|Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.|Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||% of energy target||Standard Deviation|Mean
101632|NCT00802503|Secondary|Antibiotic Free Days|Number of days between day 9 to day 28 (follow-up period) free of antibiotics|20 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||number of days||95% Confidence Interval|Mean
101633|NCT00802503|Secondary|Hours on Mechanical Ventilation in All Patients|Mechanical ventilation hours during study duration (days 1-28)|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).||hours of mechanical ventilation||95% Confidence Interval|Mean
101634|NCT00802503|Primary|Documented Infection Rate|Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28|20 days|||Infections|||Number
101635|NCT00802412|Secondary|Percent Relapsing to Any Drinking or Illicit Drug Use|Alcohol or illicit drug use during treatment or follow up.|12-week treatment phase, 36-week combined treatment and follow-up|||percentage of participants|||Number
101636|NCT00802412|Primary|4-week Continuous Abstinence From Smoking|This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.|Weeks 8-12 of treatment.|||percentage of participants abstinent|||Number
101637|NCT00802360|Secondary|Number of Live Births||Approximately 10 months|Database was locked prior to all participants giving birth.||live births|||Number
101638|NCT00802360|Secondary|Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable)~Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Day 1 - week 12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study||participants|||Number
102090|NCT00796822|Secondary|Metabolics (i.e., Fasting Lipid Profile, Glucose, Insulin)||Measured at baseline and Weeks 4 and 8||||||
101642|NCT00802360|Secondary|Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle|A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|Day 1 to Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||participants|||Number
101643|NCT00802360|Secondary|Number of Embryos Frozen at Day 24|The number of embryos that were not transferred but instead were frozen for future use.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes fertilized||embryos||Standard Deviation|Mean
101644|NCT00802360|Secondary|Number of Embryos Transferred at Three Stages of Development|The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had embryos transferred.||embryos||Standard Deviation|Mean
101645|NCT00802360|Secondary|Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.|Approximately Day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.||proportion of oocytes retrieved||Standard Deviation|Mean
101646|NCT00802360|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.|Approximately Day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.||oocytes||Standard Deviation|Mean
101647|NCT00802360|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|Day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication||follicles||Standard Deviation|Mean
101648|NCT00802178|Secondary|Global Clinical Assessments of Efficacy of Mirapexin® for All Patients|Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.|4 - 8 weeks|Treated set (TS)||Number of Participants|||Number
101649|NCT00802178|Secondary|Change From Baseline in UPDRS Part III|Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).|Baseline and 4 - 8 weeks|Full Analysis set (FAS)||Unit on a scale|||Number
101650|NCT00802178|Secondary|Change From Baseline in UPDRS (Unified Parkinson’s Disease Rating Scale) Part I|Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)|Baseline and 4 to 8 weeks|Full Analysis set (FAS)||Unit on a scale|||Number
101651|NCT00802178|Primary|Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated|"Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.~De-novo patients were identified by:~those who were referred: - if ‘Reason for Referral’ = ‘initiation of therapy’ or for ‘diagnostic reason’ and for those not referred: - if initial pharmacotherapy = ‘Mirapexin® monotherapy’ (i.e., no other anti Parkinson Disease (PD) therapy)"|4 - 8 weeks|Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated||Participants|||Number
101652|NCT00802100|Secondary|Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment||Measured over 28 weeks of study visits|Analysis population is those randomized. Outcome is discontinuation from study treatment before 28 weeks||participants|||Number
101653|NCT00802100|Primary|Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study|Goal was to randomize 60 participants who met eligibility criteria.|Baseline|Total study population||participants|||Number
101654|NCT00802074|Primary|CL/F: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||L/h||90% Confidence Interval|Mean
101655|NCT00802074|Primary|AUC: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng*h/mL||90% Confidence Interval|Mean
101656|NCT00802074|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng/mL||90% Confidence Interval|Mean
101657|NCT00802074|Primary|CL/F: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||L/h||90% Confidence Interval|Mean
101658|NCT00802074|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare AE's for each sequence and not for each regimen. 3The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004)."|Day 0 through Day 49|||participants|||Number
101659|NCT00802074|Primary|AUC: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng•h/mL||90% Confidence Interval|Mean
101660|NCT00802074|Primary|Cmin/Cmax: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng/mL||90% Confidence Interval|Mean
101661|NCT00801983|Primary|Musculoskeletal Discomfort|"Discomfort Survey (WDS) was used to assess symptoms and activity limitations. Participants reported on their work schedule, medication used for pain control, and discomfort in their neck/shoulder, back, and bilateral lower arms (elbows, forearms, wrists, and hands) using an 11-point numerical rating scale (0 = no discomfort/no limitations; 10 = unbearable discomfort/major limitations).~We had to dichotomize the data during analysis due to severe skew towards not discomfort (0). Thus the final outcome was discomfort -yes or no"|6 months and 12 months|||percentage of subjects with MSD|||Number
101662|NCT00801892|Secondary|Glucose Variability Will be Measured by a Continuous Glucose Monitoring System (CGMS) (Guardian: Medtronic-MiniMed, Northridge, CA).||after one-month||||||
101663|NCT00801892|Primary|The Primary Outcome Variable of the Study, Physical Activity, Will be Measured by the Bodymedia SenseWear Pro Armband® to Determine Physical Activity Levels.||after one-month treatment|||steps walked||Standard Deviation|Mean
101664|NCT00801801|Secondary|Response Rate in Poor Performance Status Subjects|To assess response rate and tumor control rate (complete remission + partial remission + stable disease) in poor performance status (PS =2) patients with advanced or metastatic (Stage IIIB – pleural effusion/IV) non-squamous cell-NSCLC treated with metronomic chemotherapy plus sorafenib.|24 months||10/2016||||
102091|NCT00796822|Secondary|Inflammatory Biomarkers (i.e., MCP-1, sVCAM-1, IP-10, MMP-9, TIMP-1, PAI-1 Active, hsCRP)||Measured at baseline and Weeks 4 and 8||||||
101665|NCT00801801|Primary|2-month Progression-free Survival|Evaluation of the 2-month progression-free survival in poor performance status patients with non-squamous non-small cell lung cancer with the goal to improve 2-month progression free survival from 50% to 70%.|2 months|As the study did not accrue the maximum sample size for statistical analysis, none were done.||Participants|||Number
101666|NCT00801684|Secondary|Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP|Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.|up to 24 hours post-treatment|The PK population consisted of all subjects who received active study medication and had sufficient concentration data to facilitate calculation of the PK parameters or descriptive statistics of concentrations of trospium.||Hours||Full Range|Median
101667|NCT00801684|Secondary|FEV1 Response to Treatment|Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.|Up to 24 hours post-treatment|All 24 randomized subjects were included in the analysis.||Participants|||Number
101668|NCT00801684|Primary|Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose."|15 minutes to 24 hours post-treatment|||Liters||Standard Deviation|Mean
101669|NCT00801632|Secondary|Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection|Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat||Percentage of Participants||95% Confidence Interval|Number
101670|NCT00801632|Secondary|Time to Platelet Recovery Following Transplant|Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat||days||Standard Deviation|Mean
101671|NCT00801632|Secondary|Time to Neutrophil Recovery Following Transplant|Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat||days||Standard Deviation|Mean
101672|NCT00801632|Secondary|Percentage of Participants Surviving Through 156 Weeks|The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced death prior to week 156||Percentage of Participants||95% Confidence Interval|Number
101673|NCT00801632|Secondary|Percentage of Participants With Graft Survival Through 156 Weeks|The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced graft loss prior to week 156||Percentage of Participants||95% Confidence Interval|Number
101674|NCT00801632|Secondary|Change in Renal Function|Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys.|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat||mg/dL||Standard Deviation|Mean
101675|NCT00801632|Secondary|Percentage of Participants Experiencing Acute Rejection|The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat||Percentage of Participants||95% Confidence Interval|Number
101676|NCT00801632|Primary|Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks|A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first.|48 months post-transplant|Intent-to-treat||participants|||Number
101677|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.|Up to 3 x 31 months|Safety Analysis Set.||participants|||Number
102092|NCT00796822|Secondary|Immunologic Parameters (i.e., Activated CD8 Cell Percentage, CD4 Cell Count)||Measured at baseline and Weeks 4 and 8||||||
102545|NCT00793793|Secondary|Sustained Virologic Response (SVR)|Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).|week 72|FAS||percentage of responders|||Number
101678|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.|Up to 3 x 31 months|Safety Analysis Set.||participants|||Number
101679|NCT00801242|Secondary|Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.|Up to 31 months|FAS, Cycle 1.||units on a scale||Standard Deviation|Mean
101680|NCT00801242|Secondary|Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Up to 31 months|FAS, Cycle 1||units on a scale||Standard Deviation|Mean
101681|NCT00801242|Secondary|Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.||participants|||Number
101682|NCT00801242|Secondary|Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1.||days||95% Confidence Interval|Median
101683|NCT00801242|Secondary|Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.||percentage of baseline||Standard Deviation|Mean
101684|NCT00801242|Primary|Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1, i.e. a subset of all FAS participants who completed the 7 months' induction treatment period of the first cycle and were enrolled in the off-treatment period (of the first cycle) and had at least one efficacy assessment (i.e. PSA or testosterone determination) during the off-treatment period.||days||95% Confidence Interval|Median
101685|NCT00801229|Primary|"Participants Experiencing Collisions During Surprise Events in Driving Simulator"|"Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, surprise events, designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo."|6 weeks|Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total).||participants|||Number
101686|NCT00801099|Secondary|Sustainability of the Intervention in This Setting||during 3 month of study phase||||||
101687|NCT00801099|Primary|Number of Participants With Surgical Site Infections||within 30 days postoperative|||participants|||Number
101688|NCT00800982|Primary|Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.|Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.|Weeks 12-24|All patients that completed the trial through week 24 were used for analysis.||participants|||Number
101689|NCT00800865|Primary|Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy|Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.|24, 32, and 48 hours post dose|||Ratio||90% Confidence Interval|Mean
101690|NCT00800865|Primary|Level of Biomarkers|Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).|Baseline, 24, 32, and 48 hours post dose|Actual number of participants analyzed in Part I varied from 13 to 15, depending on time point. Actual number of participants analyzed in Part II was 16 for all time points.||Percent pCDC2-positive cells||90% Confidence Interval|Geometric Mean
101691|NCT00800839|Secondary|2-year Overall Survival|Overall Survival (OS) is defined as the interval between day of transplant and day of death.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years|||percentage of participants||95% Confidence Interval|Number
101693|NCT00800839|Secondary|Rate of Engraftment|Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.|From engraftment to 60 days post transplant|||days||Full Range|Median
101694|NCT00800839|Primary|Day-100 Treatment-Related Mortality|Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.|100 days post transplant|||percentage of participants||95% Confidence Interval|Number
101695|NCT00800839|Primary|Cumulative Incidence of Grade III to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant|||percentage of incidence||95% Confidence Interval|Number
101696|NCT00800839|Primary|Cumulative Incidence of Grade II to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant|||percentage of incidence||95% Confidence Interval|Number
101697|NCT00800735|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event.|An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline through 24 weeks after the end of treatment (up to 72 weeks)|All enrolled patients.||Percentage of participants|||Number
101698|NCT00800683|Secondary|Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|first administration of randomised treatment to ....|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG||participants|||Number
101699|NCT00800683|Secondary|Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time|Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.|Baseline and Week 52|Treated Set||Participants|||Number
101700|NCT00800683|Secondary|FPG Change From Baseline at week52|This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 52|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
101701|NCT00800683|Secondary|FPG Change From Baseline at Week 48|This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 48|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
101702|NCT00800683|Secondary|FPG Change From Baseline at Week 42|This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 42|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
101703|NCT00800683|Secondary|FPG Change From Baseline at Week 36|This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 36|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
101704|NCT00800683|Secondary|FPG Change From Baseline at Week 30|This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 30|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
101705|NCT00800683|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
101706|NCT00800683|Secondary|FPG Change From Baseline at Week 18|Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
101707|NCT00800683|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Least Squares Mean
102104|NCT00796744|Secondary|The Rate of Re-epithelialization of the Ulcer Site.|The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.|12 weeks|||percent ulcer area re-epithelialized/wk||Standard Deviation|Mean
101708|NCT00800683|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 52|The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).|Baseline and Week 52|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||Percentage of patients|||Number
101709|NCT00800683|Secondary|The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=7.0%. Non-completers were considered as failure imputation (NCF).||Percentage of patients|||Number
101710|NCT00800683|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=6.5%. Non-completers were considered as failure imputation (NCF).||Percentage of patients|||Number
101711|NCT00800683|Secondary|HbA1c Change From Baseline at Week 48|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 48|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101712|NCT00800683|Secondary|HbA1c Change From Baseline at Week 42|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 42|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101713|NCT00800683|Secondary|HbA1c Change From Baseline at Week 36|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 36|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101714|NCT00800683|Secondary|HbA1c Change From Baseline at Week 30|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 30|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101715|NCT00800683|Secondary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 24|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101716|NCT00800683|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 18|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101717|NCT00800683|Secondary|HbA1c Change From Baseline at Week 52|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 52|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101718|NCT00800683|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 12|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Least Squares Mean
101719|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6|Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
101966|NCT00798161|Secondary|Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.|Baseline and week 24|Meal tolerance test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Mean
101720|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6|Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Median
101721|NCT00800540|Secondary|Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6|End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
101722|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks|Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
101723|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6|Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||cm/s (centimeters per second)|Participants|Standard Error|Mean
101724|NCT00800540|Secondary|Mean Change From Baseline in Systolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)||Standard Error|Mean
101725|NCT00800540|Secondary|Mean Change From Baseline in Diastolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)||Standard Error|Mean
101726|NCT00800540|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6|Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
101727|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||Arbitrary Units|Participants|Standard Error|Mean
101728|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.||Arbitrary Units|Participants|Standard Error|Mean
101729|NCT00800540|Secondary|Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6|Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
101744|NCT00800254|Secondary|Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 1 year|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||change in N-m/kg||Standard Deviation|Mean
101730|NCT00800540|Primary|Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6|Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
101731|NCT00800436|Secondary|Terminal Elimination Half-Life (T1/2) of Trastuzumab|T1/2 of trastuzumab was measured as the time required for trastuzumab concentration to decrease by one-half. T1/2 was derived across all PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population||hours||Standard Deviation|Mean
101732|NCT00800436|Secondary|Time to Maximum Serum Concentration (Tmax) of Trastuzumab|Tmax of trastuzumab was based on the Cmax derived across all post-dose PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population||hours||Full Range|Median
101733|NCT00800436|Secondary|Maximum Observed Serum Concentration of Trastuzumab (Cmax)|Cmax of trastuzumab was derived across all post-dose PK collections and expressed in μg/mL.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population||μg/mL||Standard Deviation|Mean
101734|NCT00800436|Secondary|Trough Serum Concentration on Day 22 (CDay22) of Trastuzumab|CDay22 of trastuzumab was derived from the single PK collection on Day 22 and expressed in micrograms per milliliter (μg/mL).|Day 22|PK Population||μg/mL||Standard Deviation|Mean
101735|NCT00800436|Primary|Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Trastuzumab|AUCinf represents the area under the concentration-time curve of trastuzumab in serum over the time interval from 0 extrapolated to infinity. Values for AUCinf of trastuzumab were derived by non-compartmental analysis across all pharmacokinetic (PK) collections and expressed in days by micrograms per milliliter (days•μg/mL).|Predose (0 hours) and postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population: All enrolled participants who adhered to the protocol (per protocol basis).||days•μg/mL||Standard Deviation|Mean
101736|NCT00800384|Secondary|Perioperative Complication Rate|A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.|30 days|Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.||participants|||Number
101737|NCT00800384|Primary|First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death|The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.|Mean follow-up of 3.1 years|All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.||participants|||Number
101738|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
101739|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
101740|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||meters||Standard Deviation|Mean
101741|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
101742|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||seconds||Standard Deviation|Mean
101743|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||meters||Standard Deviation|Mean
101745|NCT00800254|Primary|Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 3.5 weeks|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.||change in N-m/kg||Standard Error|Mean
101746|NCT00800202|Secondary|Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST|Overall response defined as best response according to RECIST recorded from date of randomization until disease progression or recurrence. Complete Response (CR): disappearance of all target lesions; Partial response (PR): reduction by at least 30 percent (%) of sum of the longest diameters of each target lesion, taking initial sum of longest diameters as a reference. Participants with a missing response were considered non-responders. 95% CI for one sample binomial using Pearson-Clopper method.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population||percentage of participants||95% Confidence Interval|Number
101747|NCT00800202|Secondary|Time to Death|Time to death was determined as the number of months between the first dose of study treatment and the event of death by any cause. Overall survival was analyzed using the Kaplan-Meier method.|Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population; only participants with an event of death were included in the analysis.||months||95% Confidence Interval|Median
101748|NCT00800202|Secondary|Probability of Being Alive at 12 and 18 Months||Months 12 and 18|ITT Population||percent||95% Confidence Interval|Number
101749|NCT00800202|Secondary|Percentage of Participants Who Died||Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population||percentage of participants|||Number
101750|NCT00800202|Primary|Time to Disease Progression or Death|Tumor progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. Time to event was determined as the number of months between the first dose of study treatment and the first event of progression or death by any cause. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population; only participants with progression or death were included in the analysis.||months||95% Confidence Interval|Median
101751|NCT00800202|Primary|Percentage of Participants With Disease Progression or Death|Tumor progression was defined according to the RECIST criteria as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population||percentage of participants|||Number
101752|NCT00800202|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Tumor progression was defined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|6 months|ITT Population||percentage of participants||95% Confidence Interval|Number
101753|NCT00798967|Secondary|Absolute Change in PN/I.V. Volume From Baseline to Last Time Point|Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).|Week 0 to last visit when data was collected.|Intent-to-Treat (ITT) was defined for efficacy analyses which included all randomized patients.||Liters/Week||Standard Deviation|Mean
101754|NCT00798967|Primary|Responder|Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.|Weeks 20 and 24|Percentages were based on the number of subjects in the Intent to Treat (ITT) population.||subjects|||Number
101755|NCT00798889|Primary|Duration of Treatment||Baseline up to Day 28 after last dose of study treatment|The intent-to-treat population included all participants who were enrolled in the study and received at least 1 dose of study medication.||Days||Full Range|Median
101756|NCT00799825|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes.||Throughout the study (up to Month 12)|The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.||Subjects|||Number
101757|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.||Subjects|||Number
102105|NCT00796744|Secondary|The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.||Duration of subject's participation (24 weeks)|Safety Population||patients|||Number
101758|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.||Subjects|||Number
101759|NCT00799773|Secondary|B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101760|NCT00799773|Secondary|Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101761|NCT00799773|Secondary|Effect of Plasma Exchange on Rituximab Levels||Measured at Month 6|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101762|NCT00799773|Secondary|Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101763|NCT00799773|Secondary|Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101764|NCT00799773|Secondary|Treatment-related Complications||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101765|NCT00799773|Secondary|All Cause Mortality||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101766|NCT00799773|Secondary|Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101767|NCT00799773|Secondary|Relationship Between Clinical and Laboratory Data and Response to Treatment||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101768|NCT00799773|Secondary|Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101769|NCT00799773|Secondary|Use of Non-study Treatment||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101770|NCT00799773|Primary|Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.|||||
101771|NCT00799708|Secondary|Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.|Change from baseline in unstimulated labial gland saliva flow rate at Day 7|Baseline and Day 7|All subjects with salivary flow rate measured at baseline and 7 days||μL/min||90% Confidence Interval|Least Squares Mean
101906|NCT00798486|Secondary|Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit|Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).|One hour|||number of participants|||Number
101772|NCT00799708|Primary|Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7|Subset of genes on the log ratio intensity scale from a microarray platform – signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens– quantified as a ratio of up regulated versus down regulated genes|Baseline and Day 7|All subjects with salivary gland tissue with RNA of acceptable quality based on pre-specified QC criteria||Fold change||Standard Error|Least Squares Mean
101773|NCT00799643|Secondary|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy||24 and 48 weeks||||||
101774|NCT00799643|Secondary|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups; Need for Rescue Therapy; Need for Discontinuation of Study Medication||24 and 48 weeks||||||
101775|NCT00799643|Secondary|Changes in WBC and Differential, High-sensitivity C Reactive Protein (hsCRP), Other Inflammatory Markers||24 and 48 weeks||||||
101776|NCT00799643|Secondary|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)||48 weeks||||||
101777|NCT00799643|Secondary|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%||24 and 48 weeks||||||
101778|NCT00799643|Secondary|Change From Baseline in Fasting Glucose Over Time.||48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks||mg/dl||95% Confidence Interval|Mean
101779|NCT00799643|Primary|The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.|HbA1c (%, percentage of HbA1c) change from baseline.|48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks||HbA1c units are %||95% Confidence Interval|Mean
101780|NCT00799604|Primary|The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum percent change is defined as the maximum absolute change divided by the baseline value of bolus 1 and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.||percent change||Standard Deviation|Mean
101781|NCT00799604|Secondary|Change in Heart Rate After Bolus 1 (Pre-anesthesia).|The baseline heart rate was measured as the median of all the heart rate measurements within 60 seconds or at the start of the administration of Bolus 1.|Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia).|Safety population: all enrolled patients (irrespective of eligibility) who are dosed with clevidipine. The safety population will be the primary population used for the safety analyses.||beats per minute (bpm)||Standard Deviation|Mean
101782|NCT00799604|Secondary|The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Analysis is of the time in minutes between the recorded time at the maximum absolute change and the time of the systolic blood pressure value at the first 50% recovery. The 50% recovery value is equal to the minimum recorded systolic blood pressure value plus 50% of the maximum amount of systolic blood pressure reduction (the Bolus 1 baseline value minus the value at the maximum absolute change).|Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||minutes||95% Confidence Interval|Median
101783|NCT00799604|Secondary|The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. SBP change (percent change) from baseline is calculated at each collection time point after bolus 1 dose for each patient.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||percent change||Standard Deviation|Mean
101784|NCT00799604|Secondary|The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. The time at which first target SBP reduction (ex. 5%) from baseline was reached was identified for each patient using fitted values from LOWESS method. Kaplan-Meier method was used to estimate the median time. Patients who never reached 5%, 10% or 15% reduction, withdrew from study or changed antihypertensive within 15 minutes were censored.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||minutes||95% Confidence Interval|Median
101785|NCT00799604|Secondary|The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|The percentage is calculated using the number of patients with a systolic blood pressure ≤85 mm Hg within 15 minutes from the initial Bolus 1 dose divided by the total number of patients who were treated with a Bolus 1 clevidipine, and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.||percent patients||95% Confidence Interval|Number
101786|NCT00799604|Primary|The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.||mm Hg||Standard Deviation|Mean
101787|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination|Microbiological sampling results categorized according to direct examination (identification of the class of germs).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation; participants may be represented in >1 category.||percentage of participants|||Number
101788|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture|Microbiological sampling results categorized as a positive blood culture (presence of infection).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation.||percentage of participants|||Number
101789|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.||percentage of participants|||Number
101790|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.||percentage of participants|||Number
101791|NCT00799591|Secondary|Mean Duration (Days) of Treatment With Tigecycline||Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population||days||Standard Deviation|Mean
101792|NCT00799591|Secondary|Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose|Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.|Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population||percentage of participants|||Number
101793|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants with analyzable data at observation.||percentage of participants||95% Confidence Interval|Number
101794|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|End of Treatment (on the day of last dose of study treatment) or up to 25 months|Intent-to-Treat (ITT): all participants included in the study who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
101795|NCT00799578|Primary|Normalization or >50% of Serum ALT Levels From Baseline||6 months|||participants|||Number
101796|NCT00799487|Secondary|Hour 8.75 Packet Activity - Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101982|NCT00798135|Secondary|Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment|Number of patients with Adverse Events grade 3 or 4 that are related to study treatment. This will look into the safety of the study drug.|up to 100 months|All patients in the study.||Participants|||Number
101797|NCT00799487|Secondary|Hour 8.75 Packet Activity - Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101798|NCT00799487|Secondary|Hour 8.75 Packet Activity - Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101799|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101800|NCT00799487|Secondary|Hour 8.75 Packet Activity - Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101801|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identiy Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101802|NCT00799487|Secondary|Hour 8.75 Packet Activity - Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order)(range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101803|NCT00799487|Secondary|Hour 3.0 Grammar Task|This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101960|NCT00798304|Secondary|Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
101804|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Number of targets missed. Higher score is preferable (observed range: -419.4, 108.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Targets missed||Standard Deviation|Mean
101805|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
101806|NCT00799487|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (observed range: 0, 212), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. Children read 3 stories and completed the forms. A higher score was preferable and indicated a greater number of words read correctly in the time allowed|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101807|NCT00799487|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)|The THS-R is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes the 10 subtests: writing from memory the upper- and lower-case letters of the alphabet in order, writing from dictation the upper and lower-case letters of the alphabet out of order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). A higher score was preferable (observed range: 0, 118).|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101808|NCT00799487|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT)|Gray Silent Reading Test (GSRT) is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (observed range: 0, 141). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101809|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
101810|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Responses to non-targets. Higher score is preferable (observed range: -82.4, 128.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Responses to non-targets||Standard Deviation|Mean
101811|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
101812|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Correct Sequences||Standard Deviation|Mean
101813|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. SD of response times (msecs) (observed range: -177.6, 132.9). Higher score indicates less variability.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||milliseconds||Standard Deviation|Mean
101814|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Mean response latency in msecs (observed range: -75.4, 129.5). Higher score indicates faster reaction time.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Milliseconds (msecs)||Standard Deviation|Mean
101815|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target (observed range: -15.2, 5.2). An ADHD score of less than -1.80 is suggestive of ADHD.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101816|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of child impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101817|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101818|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0,36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Units on a scale||Standard Deviation|Mean
101819|NCT00799487|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Problems correct||Standard Deviation|Mean
101820|NCT00799487|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable.)|Hour 4 of the Double-Blind Assessment Period Lab School Day|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.||Problems attempted||Standard Deviation|Mean
101821|NCT00799474|Secondary|Knowledge of HPV|Assessed participants' knowledge of HPV by summing correct responses to nine HPV knowledge items. Questions addressed what diseases are associated with HPV, how HPV is transmitted, and how common HPV infection is. For each item, participants were classified as having answered the item correctly or incorrectly.|At time of interview|HPV knowledge items were only asked to those men who had heard of HPV prior to survey (n=430)||Correct Responses||Standard Deviation|Mean
101822|NCT00799474|Secondary|Awareness of HPV Vaccine|"Measured if participants had heard of HPV vaccine prior to survey. Participants were asked if they had heard to HPV vaccine prior to the survey and had response options of yes, no, and I don't know."|At time of interview|||Participants|||Number
101823|NCT00799474|Primary|Willingness to Receive the Human Papillomavirus (HPV) Vaccine|"Measured participants' willingness to receive HPV vaccine. Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males. A 5-point scale ranging from definitely not willing to definitely willing was used to meausure willingness."|at time of interview|One man reported having received human papillomavirus (HPV) vaccine so he was not asked willingness items which made the analytic sample size n=608||Participants|||Number
101824|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week|Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.||mm||Standard Deviation|Mean
101825|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week|Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.||mm||Standard Deviation|Mean
101826|NCT00799422|Primary|Mean Circumlimbal Conjunctival Staining Score|Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.|1 week|This reporting group includes all participants who completed all study visits.||Units on a scale||Standard Deviation|Mean
101827|NCT00799409|Secondary|Hour 8.75 Packet Activity Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101961|NCT00798304|Secondary|Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
101828|NCT00799409|Secondary|Hour 8.75 Packet Activity Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101829|NCT00799409|Secondary|Hour 8.75 Packet Activity Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101830|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101831|NCT00799409|Secondary|Hour 8.75 Packet Activity Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101832|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101833|NCT00799409|Secondary|Hour 8.75 Packet Activity Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101834|NCT00799409|Secondary|Hour 3.0 Grammar Task|This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101835|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101836|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Trials||Standard Deviation|Mean
101962|NCT00798304|Primary|Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 3|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
101837|NCT00799409|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed.|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101838|NCT00799409|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score|The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101839|NCT00799409|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient|Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101840|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Trials||Standard Deviation|Mean
101841|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101842|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Sequences||Standard Deviation|Mean
101843|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Correct Sequences||Standard Deviation|Mean
101844|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101845|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101846|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101847|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101848|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101849|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Units on a scale||Standard Deviation|Mean
101850|NCT00799409|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.||Problems correct||Standard Deviation|Mean
101851|NCT00799409|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)|Hour 4 of the of the Lab School Day during Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point. Intent-to-Treat for Placebo and Concerta columns in the primary and secondary results are comprised of the 36 children randomized to Placebo/CONCERTA (lab day 1/lab day 2) plus the 35 children randomized to CONCERTA/Placebo||Problems attempted||Standard Deviation|Mean
101852|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel Plus Aspirin|Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation|Measured at baseline, and after clopidogrel plus aspirin treatment|||percentage of max aggregation change||Standard Deviation|Mean
101853|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel|Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.|Measured at baseline, and after clopidogrel treatment|||percentage of maximum aggregation change||Standard Deviation|Mean
101854|NCT00799292|Primary|Estimated Blood Loss|Estimated blood loss as mL|Duration of vaginal hysterectomy|||mL||Standard Deviation|Mean
101855|NCT00799292|Secondary|Operative Time and Complication Rates||Duration of procedures and immediate post-operative stay in hospital||||||
101856|NCT00799292|Primary|Intra-operative Blood Loss During Vaginal Hysterectomy||Blood loss will be assessed at the end of the operative procedure||||||
101857|NCT00799227|Secondary|Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye|Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%).|Baseline, Week 26|Intent to Treat: all enrolled patients||Percentage of Patients|||Number
101858|NCT00799227|Secondary|Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to treat: all enrolled patients||Percentage of Patients|||Number
101859|NCT00799227|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients||Letters Read Correctly||Standard Deviation|Mean
101860|NCT00799227|Primary|Change From Baseline in Central Retinal Thickness in the Study Eye|Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients||Microns||Standard Deviation|Mean
101861|NCT00798759|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.||Units on a scale||Standard Error|Mean
101862|NCT00798759|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.||Seconds||Standard Error|Mean
101863|NCT00798720|Secondary|Toxicity|Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|30 days post-treatment|||participants|||Number
101864|NCT00798720|Secondary|Median Overall Survival||5 years|||months||95% Confidence Interval|Median
101865|NCT00798720|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Until disease progression, up to 2 years|||participants|||Number
101866|NCT00798720|Primary|Three-month Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Three-months post-treatment|||percentage of participants||95% Confidence Interval|Number
101867|NCT00798707|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of “new symptoms” and “old (but worse) symptoms” (1) and 0 for “old and unchanged symptom,” “absent,” or “old symptom but improved” for a total possible range of 0 to 43. A higher score indicates more symptoms.|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
101868|NCT00798707|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of “Yes” on “Actual Attempt”),preparatory acts toward imminent suicidal behavior (3)(“Yes” on “Preparatory Acts or Behavior”),suicidal ideation (4)(“Yes” on “Wish to be dead”,“Non-Specific Active Suicidal Thoughts”,“Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(“Yes” on “Has subject engaged in Non-suicidal Self-Injurious Behavior”).|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Participants|||Number
101869|NCT00798707|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.||Percentage of Participants|||Number
101870|NCT00798707|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
101963|NCT00798161|Secondary|Use of Rescue Therapy|The use of rescue therapy (SUs, thiazolidinediones [TZDs], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a ‘confirmed’ glucose level after an overnight fast.|24 weeks|Percentage of patients requiring rescue therapy||percentage of participants|||Number
101871|NCT00798707|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.||Units on a scale||Standard Error|Mean
101872|NCT00798707|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.||nanogram(ng)/mL||Standard Deviation|Mean
101873|NCT00798707|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
101874|NCT00798707|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
101875|NCT00798707|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
101876|NCT00798707|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
101877|NCT00798707|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit,LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
101878|NCT00798707|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
101879|NCT00798707|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Units on a scale||Standard Error|Mean
101983|NCT00798135|Primary|Pharmacokinetics (PK) of Oral Itraconazole|To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.|pre-dose at Weeks 2 and 4|All patients with results available.||ng/mL||Standard Deviation|Mean
101880|NCT00798707|Secondary|Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.||Participants|||Number
101881|NCT00798707|Primary|Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.||Units on a scale||Standard Error|Mean
101882|NCT00798655|Secondary|Probability of 2-year Overall Survival||Up to 90 months for cohort; individual patients up to 24 months|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.||percentage of participants||95% Confidence Interval|Number
101883|NCT00798655|Primary|Probability of Progression-free Survival (PFS) at 2 Years||Up to 90 months for cohort; individual patients up to 24 months after study treatment|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.||percentage of participants||95% Confidence Interval|Number
101884|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 nausea data.||units on a scale||Full Range|Median
101885|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 nausea data.||units on a scale||Full Range|Median
101886|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 neuropathy data.||units on a scale||Full Range|Median
101887|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 neuropathy data.||units on a scale||Full Range|Median
101888|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 fatigue data.||units on a scale||Full Range|Median
101889|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 fatigue data.||units on a scale||Full Range|Median
101890|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LASA data.||units on a scale||Full Range|Median
101891|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LASA data.||units on a scale||Full Range|Median
101892|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LCSS data.||units on a scale||Full Range|Median
101893|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LCSS data.||units on a scale||Full Range|Median
101894|NCT00798603|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.||months||95% Confidence Interval|Median
101895|NCT00798603|Secondary|Progression-free Survival|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.||months||95% Confidence Interval|Median
101896|NCT00798603|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from date of registration to the date at which the patient is removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.||months||95% Confidence Interval|Median
101897|NCT00798603|Secondary|Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Up to 2.5 years|All participants who received treatment.||particpants|||Number
101898|NCT00798603|Secondary|Duration of Response|Duration of response for responders was defined as the time from the date of the first objective status assessment of a confirmed CR or PR to the first date of disease progression. Duration of response will be censored at the date of last post-therapy follow-up visit for responders who have not had disease progression. Duration of response will be calculated for all evaluable patients who have achieved an objective confirmed response.|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.||months||95% Confidence Interval|Median
101899|NCT00798603|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.~Partial Response (PR): disappearance of all target lesions, persistence of one or more non-target lesions, and no new lesions; or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, no appearance of one/more new lesions, unequivocal progression of existing non-target lesions, and no new lesions."|Duration of study until progression (up to 5 years)|All participants who met the eligibility criteria, have started the study treatment and have post-baseline disease assessments.||percentage of participants||95% Confidence Interval|Number
101900|NCT00798603|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.|6 months|The first 55 participants who met the eligibility criteria and have started the study treatment.||percentage of participants||95% Confidence Interval|Number
101901|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose|No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1.||Percent bacteria eradicated|||Number
101902|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hour after administration of first dose|No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1||Percent bacteria eradicated|||Number
101903|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose|||Percent bacteria eradicated|||Number
101904|NCT00798577|Secondary|Exploratory Evaluation of Changes in Ocular Signs and Symptoms|"Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis:~Bulbar Conjunctival Injection – 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema – 0 (none) to 3 (Severe) scale. Lid Swelling – 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva – 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale."|Baseline (Day 1) to Day 2|||Participants|||Number
101905|NCT00798577|Primary|Exploratory Outcomes From Digital Photography|Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.|24 hours after administration of first dose|||Participants|||Number
101907|NCT00798486|Secondary|Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing|"For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as:~The subject could not use the product without HCP assistance.~The subject could not complete the test. User error rendered one or more parts unusable.~The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value."|One hour|||percentage of subjects|||Number
101908|NCT00798486|Secondary|Average Within Subject Coefficient of Variation CV (PRECISION)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|One hour|Precision Coefficient of Variation (CV)was analyzed using meter results from subject data that had numeric values for duplicate A1c self-tests. Subject data was not used in this outcome measure analysis when there had been a protocol deviation or when one (or both) A1c self-tests resulted in an error code.||average percentage CV|||Number
101909|NCT00798486|Primary|Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)|This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.|One hour|||number of A1c results|||Number
101910|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.||Episodes per 24 hours||Full Range|Median
101911|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.||Micturitions per 24 hours||Standard Deviation|Mean
101912|NCT00798434|Other Pre-specified|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.||Micturitions per 24 hours||Standard Deviation|Mean
101913|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.||Episodes per 24 hours||Standard Deviation|Mean
101914|NCT00798434|Other Pre-specified|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of >=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.||Episodes per 24 hours||Standard Deviation|Mean
101915|NCT00798434|Other Pre-specified|Percentage of Participants With Improvement at Week 24|Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: “My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment.” Treatment Response was set to “Yes” if the first 2 categories (1 or 2) of the scale selected and “No” if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2.|Pre-baseline and Week 24|Not analyzed||Percentage of participants|||Number
101916|NCT00798434|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.|Baseline and Week 12|FAS||Scores on a scale||Standard Deviation|Mean
101917|NCT00798434|Secondary|Change From Baseline in EQ-5D- Each Dimension Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|Not analyzed||Scores on a scale||Standard Deviation|Mean
101918|NCT00798434|Secondary|Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|FAS; N=participants with evaluable data; n=participants with evaluable data a specified time point.||Scores on a scale||Standard Deviation|Mean
101919|NCT00798434|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.|Baseline and Week 12|FAS; N=participants with evaluable data at sites in the United Kingdom only; n=participants with evaluable data for specific KHQ category. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
101920|NCT00798434|Secondary|Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24|OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
101921|NCT00798434|Secondary|Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24|OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
101922|NCT00798434|Secondary|Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.||Scores on a scale||Standard Deviation|Mean
101923|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.||Scores on a scale||Standard Deviation|Mean
101924|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.||Scores on a scale||Standard Deviation|Mean
101925|NCT00798434|Secondary|Change From Baseline in PPUS at Week 24|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 24|Not analyzed||Participants|||Number
101926|NCT00798434|Secondary|Change From Baseline in PPUS at Week 12|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Participants|||Number
101927|NCT00798434|Secondary|Change From Baseline in PPUS at Week 8|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 8|FAS; N=participants with evaluable data||Participants|||Number
101928|NCT00798434|Secondary|Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Weeks 4|FAS; N=participants with evaluable data||Participants|||Number
101929|NCT00798434|Secondary|Change From Baseline in PPBC at Week 24|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 24|Not analyzed||Participants|||Number
101930|NCT00798434|Secondary|Change From Baseline in PPBC at Week 12|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Participants|||Number
101931|NCT00798434|Secondary|Change From Baseline in PPBC at Week 8|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 8|FAS; N=participants with evaluable data||Participants|||Number
101932|NCT00798434|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline and Week 4|FAS; N=participants with evaluable data||Participants|||Number
101933|NCT00798434|Secondary|Percentage of Participants With Improvement at Week 12|Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: “My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment.” Improvement was defined as a rating of 1 or 2.|Week 12|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percentage of participants|||Number
101934|NCT00798434|Secondary|Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12|Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Skin protective agents||Standard Deviation|Mean
101935|NCT00798434|Secondary|Percentage of Participants Who Were Incontinent at Baseline and Became Dry|Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Weeks 8 to 12|FAS; N=number of participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percentage of participants|||Number
101936|NCT00798434|Secondary|Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12|USS total range 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Scores on a scale||Standard Deviation|Mean
101937|NCT00798434|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
101938|NCT00798434|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Episodes per 24 hours||Full Range|Median
101964|NCT00798161|Secondary|FPG Change From Baseline at Week 24 for Open-label Patients|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with a baseline on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.||mg/dL||Standard Deviation|Mean
101939|NCT00798434|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
101940|NCT00798434|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Micturitions per 24 hours||Standard Deviation|Mean
101941|NCT00798434|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
101942|NCT00798434|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Micturitions per 24 hours||Standard Deviation|Mean
101943|NCT00798434|Secondary|Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
101944|NCT00798434|Secondary|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Episodes per 24 hours||Standard Deviation|Mean
101945|NCT00798434|Secondary|Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of >=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS;N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).||Percent change||Full Range|Median
101946|NCT00798434|Primary|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 12|Full Analysis Set (FAS)=randomized participants who took at least 1 dose of double-blind (DB) treatment, had baseline and post-baseline efficacy data for at least 1 endpoint and at least 1 time point during DB treatment; number of participants analyzed (n)=participants with evaluable data at the specified time point.||Episodes per 24 hours||Standard Deviation|Mean
101947|NCT00798369|Secondary|Amount of Rescue Medication Taken for Each Treatment Group|Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone [30 mg]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.|7 days after study drug administration|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||mg||Standard Deviation|Mean
101965|NCT00798161|Secondary|HbA1c Change From Baseline at Week 24 for Open-label Patients|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with an on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.||Percent||Standard Deviation|Mean
101948|NCT00798369|Primary|The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)|Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).|at 24,48 and 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||mg||95% Confidence Interval|Number
101949|NCT00798369|Secondary|Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||mg/L||Standard Error|Least Squares Mean
101950|NCT00798369|Secondary|High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||mg/L||Standard Error|Least Squares Mean
101951|NCT00798369|Secondary|The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint|The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).|Baseline, within 7 days after randomization|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||Days||95% Confidence Interval|Median
101952|NCT00798369|Secondary|Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment|Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.|at 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.||Percentage of Participants|||Number
101953|NCT00798369|Secondary|The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide|The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement – baseline).|Baseline,at 72 hrs post-dose and 7 days post-dose|Full Analysis Set consisting of all participants with data for baseline and the given time point for each arm/group. Assessments up to Day 8, with 1 missing pain intensity value had it imputed. LOCF method was applied to impute post-dose measurements. Missing baseline values were replaced by the median baseline assessment||Units on a scale||Standard Error|Least Squares Mean
101954|NCT00798317|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)||percentage of participants|||Number
101955|NCT00798317|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28|Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)||percentage of participants|||Number
101956|NCT00798304|Primary|Percentage of Participants With at Least One Adverse Event (AE)||From signing of informed consent form to completion of study (up to 2 years)|||percentage of participants|||Number
101957|NCT00798304|Other Pre-specified|Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
101958|NCT00798304|Other Pre-specified|Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
101959|NCT00798304|Other Pre-specified|Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.|||||
102106|NCT00796744|Primary|The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.||Healing to occur within 12 weeks of first treatment|Intent-to-Treat Population||number of ulcers healed|||Number
101967|NCT00798161|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
101968|NCT00798161|Secondary|Percentage of Patients With HbA1c < 6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
101969|NCT00798161|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =< 6.5%|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
101970|NCT00798161|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
101971|NCT00798161|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
101972|NCT00798161|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
101973|NCT00798161|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
101974|NCT00798161|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
101975|NCT00798161|Secondary|FPG Change From Baseline at Week 2|This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 2|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
101976|NCT00798161|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
101977|NCT00798161|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
101978|NCT00798161|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
101979|NCT00798161|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
101980|NCT00798161|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
101981|NCT00798135|Secondary|Time to Progression.|This is calculated as time till progression from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. If a patient did not progress, they were censored at the last evaluation visit. The median time till progression is calculated with its 95% confidence interval.|up to 100 months|All patients in the study.||Months||95% Confidence Interval|Median
101984|NCT00798096|Secondary|Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.|Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Days||Standard Deviation|Median
101985|NCT00798096|Secondary|Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).|Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Participants|||Number
101986|NCT00798096|Secondary|Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Participants|||Number
101987|NCT00798096|Primary|The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD).|Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)|||Participants|||Number
101988|NCT00798018|Primary|Visual Analogue Scale(0-100mm) by the Subject.|visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.|6 hours, 12 hours, 24 hours, 48 hours after extubation|||mm||Standard Deviation|Mean
101989|NCT00797966|Secondary|Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).|CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved].|Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||percentage of participants|||Number
101990|NCT00797966|Secondary|Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).|A MADRS remission was defined as MADRS Total Score </= 10 and >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Percentage of participants|||Number
101991|NCT00797966|Secondary|Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).|A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Percentage of participants|||Number
101992|NCT00797966|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.|CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A.|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
101993|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.|The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The possible total scores are from 0 to 52.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
102001|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
101994|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|"The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place."|Week 8 to each of Week 9, 10, 11, 12, 13 and 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
101995|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
101996|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
101997|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
101998|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|The MADRS is utilized as the primary efficacy assessment of a patient’s level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Deviation|Mean
101999|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).|The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
102000|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).|The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5*(minimum score). Range is maximum score minus minimum score. Total score is 100*(Raw score minus minimum score)/ Range, rounded to nearest integer.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||Percentage of maximum possible score||Standard Error|Least Squares Mean
102002|NCT00797966|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.|Week 8 to Week 14|Intent-to-Treat (ITT) dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The Last Observation Carried Forward (LOCF) method was used to impute missing data.||Units on a scale||Standard Error|Least Squares Mean
102003|NCT00797862|Post-Hoc|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 & 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msSBP was a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
102004|NCT00797862|Secondary|Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints|Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints.|Baseline to week 8, 16, 24 and 32 endpoints|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure. Last post-baseline observation was carried forward to each visit for the analysis of blood pressure control.||Percentage of Participants|||Number
102005|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
102006|NCT00797862|Secondary|Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline, 8 weeks, 16 weeks and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
102007|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32|Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
102008|NCT00797862|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
102009|NCT00797862|Primary|Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks|Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline, 8 weeks, 16 weeks, and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.||mmHg||Standard Error|Least Squares Mean
102010|NCT00797823|Secondary|Percent of Time Venous Blood Glucose <70 mg/dl||1 year|||percent of time||Standard Error|Mean
102011|NCT00797823|Primary|Effectiveness of Closed Loop Diabetes Control|Effectiveness of closed loop diabetes control will be measured by mean glucose.|1 year|The number of participants for analysis was determined was per protocol.||mg/dl||Standard Error|Mean
102012|NCT00797797|Secondary|Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study|The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).|Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)|||mm||Standard Error|Least Squares Mean
102013|NCT00797797|Primary|Patient Global Impression of Change (PGIC) Responder Rate at End of Study|The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as “very much improved” or “much improved” (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.|End of Randomized treatment period (11 weeks)|All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment.||participants|||Number
102014|NCT00797667|Primary|Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.|up to 12 weeks|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.||Percentage of Participants|||Number
102015|NCT00797667|Primary|Percentage of Participants Who Experienced an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 12 weeks)|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.||Percentage of Participants|||Number
102016|NCT00797667|Secondary|Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication|Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Days per month||95% Confidence Interval|Mean
102017|NCT00797667|Secondary|Change From Baseline in the Mean Monthly Migraine Attacks|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||attacks per month||95% Confidence Interval|Mean
102018|NCT00797667|Secondary|Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized|Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Percentage of Participants||95% Confidence Interval|Number
102019|NCT00797667|Primary|Change From Baseline in Mean Monthly Migraine Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Days per month||95% Confidence Interval|Mean
102033|NCT00797316|Secondary|Percentage of Participants With Blood Pressure Response at Week 8|Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.|8 weeks|full analysis set||Percentage of Participants|||Number
102020|NCT00797667|Primary|Change From Baseline in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||Days per month||95% Confidence Interval|Mean
102021|NCT00797563|Secondary|Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour|||number of participants|||Number
102022|NCT00797563|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:~Successful~Successful after being referred to user instructions~Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol||percent of participants|||Number
102023|NCT00797563|Primary|Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.|One hour|"One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study.~The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method."||number of blood glucose (BG) results|||Number
102024|NCT00797511|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine|Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
102025|NCT00797511|Primary|Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio|Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers to the vaccine Pertussis antigens were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
102026|NCT00797511|Primary|Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination|Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
102027|NCT00797511|Primary|Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.|Day 28 post-vaccination|Anti-Pertussis concentrations were assessed in the per-protocol population.||Participants|||Number
102028|NCT00797511|Primary|Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|"Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA).~Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution)."|Day 28 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.||Participants|||Number
102029|NCT00797459|Secondary|Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline|||participants|||Number
102030|NCT00797459|Primary|Treatment Difference in Pain as Measured by a Visual Analogue Scale|No pain is noted at 0 mm and worst pain is noted at 100 mm.|After Injection on Day of Treatment|This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS).||Scores on a VAS Scale|Participants|Standard Deviation|Mean
102031|NCT00797316|Secondary|Change From Baseline to Week 8 in Pulse Pressure||Baseline and Week 8|Full analysis set||mm Hg||Standard Error|Least Squares Mean
102032|NCT00797316|Secondary|Percentage of Patients Achieving Blood Pressure Control at Week 8|Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.|8 weeks|Full analysis set||Percentage of Participants|||Number
102034|NCT00797316|Secondary|Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)||8 weeks|Full analysis set||mm Hg||Standard Error|Least Squares Mean
102036|NCT00797277|Secondary|Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection|Agitation was further assessed by the Agitation Calmness Evaluation Scale (ACES) (Copyright 1998, Eli Lilly and Company), a single-item scale developed by Eli Lilly and Company on which 1 indicates marked agitation; 2, moderate agitation; 3, mild agitation; 4, normal; 5, mild calmness; 6, moderate calmness; 7, marked calmness; 8, deep sleep; and 9, unable to be aroused.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection||units on a scale||Standard Deviation|Mean
102037|NCT00797277|Primary|The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection|The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection||units on a scale||Standard Deviation|Mean
102038|NCT00797212|Secondary|Percentage of Participant Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour|per protocol||percent of participants|||Number
102039|NCT00797212|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants as to their success at performing meter testing. The rating scale was:~Successful~Successful after being referred to user instructions~Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol||percent of participants|||Number
102040|NCT00797212|Primary|Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results|Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP|One hour|per protocol||number of AST Blood Glucose Results|||Number
102041|NCT00797108|Other Pre-specified|Number of Participants With Healthcare Resource Utilization|Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization, date of discharge, location of discharge, type/length of treatment inside and outside of the hospital, healthcare professional visits outside of the hospital, emergency room visits, and other hospitalizations.|Baseline up to 15 to 28 days after EOT|This assessment was not performed due to the small sample size and hence data for this outcome measure is not reported.|||||
102042|NCT00797108|Other Pre-specified|Population Pharmacokinetics|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study.|0.5 to 1 hours, 1.5 to 3 hours, 3 to 5 hours after initiation of first intravenous dose; 0.5 to 2.5 hours, 4 to 6 hours following administration of oral dose on the day of IV to oral switch (minimum of 2 days equivalent on intravenous dose)||||||
102043|NCT00797108|Other Pre-specified|Number of Participants With Categorical Change From Baseline in Vital Signs|Participants who met the categorical criteria for increase in vital signs data were reported. Categorical criteria for increase from baseline vital signs data: supine and sitting systolic blood pressure (BP) of greater than or equal to (>=) 30 millimeter of mercury (mmHg); supine and sitting diastolic BP of >=20 mmHg.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants evaluable for this measure for specified category for each arm, respectively.||participants|||Number
102044|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, neurological, extremities, and others. Criteria for abnormal physical findings were based on investigator’s discretion.|Last observation (up to 15-28 days after EOT, approximately 38 days)|ITT population included all randomized participants who received at least 1 dose of double blind study drug.||participants|||Number
102045|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Criteria for laboratory abnormalities: hemoglobin (Hb), hematocrit, red blood cell (RBC) (less than [<] 0.8*lower limit of normal [LLN]); reticulocyte (absolute and percentage) (<0.5*LLN or greater than [>] 1.5*upper LN [ULN]); platelet (<0.5*LLN or >1.75*ULN); white blood cell (WBC) (<0.6*LLN or >1.5*ULN); lymphocyte, neutrophil (<0.8*LLN or >1.2*ULN); eosinophil, monocyte, basophil (>1.2*ULN); bilirubin (BR) (>1.5*ULN); aspartate and alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase (>3.0*ULN); total protein, albumin (<0.8*LLN or >1.2*ULN);blood urea nitrogen, creatinine (>1.3*ULN); sodium (<0.95*LLN or >1.05*ULN); potassium, chloride, calcium, magnesium, bicarbonate (<0.9*LLN or >1.1*ULN); glucose (<0.6*LLN or >1.5*ULN); urine (pH [<4.5 or >8], glucose, protein, blood, ketone [>=1]). Total number of participants with abnormal laboratory values were reported.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
102046|NCT00797108|Other Pre-specified|Number of Participants Who Died||Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug.||participants|||Number
102055|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Serum Potassium (High) - All Treated Population|Serum potassium was measured as milliequivalents per liter (mEq/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN OR > ULN - 5.5;; GRADE (2): > 5.5 - 6.0; GRADE (3): 2.5 - < 3.0 > 6.0 - 7.0; GRADE (4): < 2.5 mEq/L.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102107|NCT00796718|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|Up to 15 weeks|All enrolled participants.||percentage of participants|||Number
102047|NCT00797108|Secondary|Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit|The CAP Symptom Questionnaire was a participant reported questionnaire administered by interview. It consisted of 12 items (coughing, chest pains, shortness of breath, sweating, chills, headache, nausea, muscle pain, lack of appetite, trouble concentrating, trouble sleeping, and fatigue). Depending on if the participant had or not had symptoms/problems, they were asked how much they had been bothered by the symptoms/problems over the previous 24 hours. CAP items were rated on the 6-point response scale (0 = participant did not have symptom/problem: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely; if the participant had the symptom/problem and were bothered). All 12 items score were summed and averaged to produce a CAP symptom score (range, 0 to 6). High values indicated poorer outcomes (higher symptom bothersomeness).|Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)|Clinically evaluable population. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
102048|NCT00797108|Secondary|Number of Participants With Microbiological Response at Test of Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication=the absence of the original pathogens from the post-treatment TOC culture of specimen from the original site of infection. Presumed eradication=the complete resolution of signs and symptoms associated with cessation of culturable specimen (for example, sputum). Persistence=the presence of the original pathogen in the post-treatment TOC culture specimen from the original site of infection. Presumed persistence=in a participant who was judged to be a clinical failure and a culture of specimen was not possible or was not done, it was presumed that there was persistence of the pathogen. Not applicable microbiologic response included participants that did not have post-treatment microbiologic cultures due to early discontinuation. Data reported for eradication is combination of eradication and presumed eradication data and data reported for persistence is combination of persistence and presumed persistence data.|7 to 14 days after EOT|Microbiologic clinically evaluable population included all microbiologic ITT participants (all ITT participants in whom a pathogen was isolated at baseline) who also met criteria for the clinically evaluable subset.||participants|||Number
102049|NCT00797108|Secondary|Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit|CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOT (Day 7 to 10) and follow-up (15 to 28 days after EOT), CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia, development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; with additional CR evaluated as “improvement”= of few not all signs and symptoms of pneumonia when compared to baseline and no additional antibacterial treatment required at EOT and “indeterminate”=extenuating circumstances precluded classification to 1 of the above at follow-up.|EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).||percentage of participants|||Number
102050|NCT00797108|Primary|Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit|Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment [EOT]) CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell [WBC] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; “indeterminate”=extenuating circumstances precluded classification to 1 of the above.|7 to 14 days after end of treatment|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).||percentage of participants|||Number
102051|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Uric Acid - All Treated Population|Uric acid was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 * ULN - 10.0; GRADE (4): > 10.0 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102052|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Lipase - All Treated Population|Total Lipase (as measured with a turbidimetric assay) was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * ULN; GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 X ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102053|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Calcium (High) - All Treated Population|Total Calcium was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 8.0 - < LLN OR > ULN - 11.5; GRADE (2): 7.0 - < 8.0 > 11.5 - 12.5; GRADE (3): 6.0 - < 7.0 > 12.5 - 13.5; GRADE (4): < 6.0 > 13.5 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102054|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Amylase - All Treated Population|Amylase was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102056|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Bilirubin - All Treated Population|Total Bilirubin was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 3.0 * ULN; GRADE (3): > 3.0 - 10.0 * ULN; GRADE (4): > 10.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102057|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alkaline Phosphatase - All Treated Population|Alkaline Phosphatase was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102058|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Albumin - All Treated Population|Albumin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): < LLN - 3.0; GRADE (2): < 3.0 - 2.0; GRADE (3): < 2.0 g/dL.|Day 1 to Week 48|||participants|||Number
102059|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Aspartate Aminotransferase (AST) - All Treated Population|AST was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|||participants|||Number
102060|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alanine Aminotransferase (ALT) - All Treated Population|ALT was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102061|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Platelet Count - All Treated Population|Platelets were measured as *10^9 cells per liter (c/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 75.0 - < LLN; GRADE (2): 50.0 - < 75.0; GRADE (3): 25.0 - < 50.0; GRADE (4): < 25.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102062|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils Plus Bands - All Treated Population|Neutrophils plus bands (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5.|Day 1 to Week 48|||participants|||Number
102063|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils - All Treated Population|Neutrophils (absolute) are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102064|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Lymphocytes - All Treated Population|Lymphocytes (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 0.8 - < 1.5; GRADE (2): 0.5 - < 0.8; GRADE (3): 0.2 - < 0.5; GRADE (4): < 0.2|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102065|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Leukocytes - All Treated Population|Leukocytes are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN; GRADE (2): 2.0 - < 3.0; GRADE (3): 1.0 - < 2.0; GRADE (4): < 1.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102066|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Hemoglobin - All Treated Population|Hemoglobin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 10.0 - less than (<) lower limit of normal (LLN); GRADE (2): 8.0 - < 10.0; GRADE (3): 6.5 - < 8.0; GRADE (4): < 6.5|Day 1 to Week 48|||participants|||Number
102067|NCT00796991|Secondary|Mean Baseline Change in Body Temperature at Weeks 16 and 48 - All Treated Population|Temperature was obtained while the participant was sitting down and was measured in degrees Fahrenheit (F). During the induction phase this vital sign was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Temperature was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a temperature value available for analysis.||degrees F||Standard Deviation|Mean
102068|NCT00796991|Secondary|Mean Change From Baseline in Respiration Rate at Weeks 16 and 48 - All Treated Population|Respiration rate was obtained while the participant was sitting down and measured in breaths per minute (bpm). During the induction phase respiration rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Respiration rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Respiration rate value available for analysis.||bpm||Standard Deviation|Mean
102087|NCT00796926|Secondary|Corneal Fluorescein Staining Score|This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any|6 weeks||||||
102069|NCT00796991|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 16 and 48 - All Treated Population|Pulse rate was obtained while the participant was sitting down and measured in beats per minute (bpm). During the induction phase pulse rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Pulse rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Pulse rate value available for analysis.||bpm||Standard Deviation|Mean
102070|NCT00796991|Secondary|Mean Change From Baseline at Weeks 16 and 48 in Diastolic and Systolic Blood Pressure - All Treated Population|Blood pressure was obtained while the participant was sitting down and was measured in millimeters of mercury (mmHg). During the induction phase blood pressure was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Orthostatic blood pressure was to be measured when clinically indicated (for example, participant was experiencing lightheadedness, dizziness, syncope). Blood pressures were recorded at Weeks 1, 4, 7, 10,13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had blood pressure value available for analysis.||mmHg||Standard Deviation|Mean
102071|NCT00796991|Secondary|Mean Absolute Lymphocyte Count (ALC) at Each Nominal Ipilimumab Induction Dose and at End of the Induction Period - Pharmacodynamic Population|Absolute lymphocyte counts were obtained from routine hematology panels from 28 days prior to the first treatment with any study medication through the end of the Induction-Dosing Period and were reported as number*10^3 cells per micro liter (x10^3 c/µL).|Day to Week 12|"Pharmacodynamic Population: All treated participants with one unambiguous date of first dose; and at least 1 ALC evaluation during the induction-dosing period. For each of these participants, all ALC evaluations from 28 days prior to first dose of any study medication to the end of the induction dosing are included.~period."||10^3 cells/µL||95% Confidence Interval|Mean
102072|NCT00796991|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, Deaths, and Discontinuation Due to Adverse Events From Day 1 to Week 48 - All Treated Population|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Week 48 database lock was 27 July 2010.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102073|NCT00796991|Secondary|Number of Participants With Objective Response to Treatment and Disease Control Using mWHO Criteria - All Randomized Participants|Number of participants with an objective response to treatment excluded participants with a best overall response (BOR) of Stable Disease (SD). Disease control is non-progression of disease while on treatment. A participant was considered to have achieved disease control if he/she had a BOR of CR, PR, or SD in the absence of resected index lesions or new lesions while the participant was considered to have an objective response to treatment in he/she had a BOR of CR or PR in the absence of resected index lesions or new lesions.|Day 1 to Week 48|Randomized Population includes all participants randomized to a treatment arm||participants|||Number
102074|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Immune Related (ir) Response Criteria (RC) - All Treated Participants|Assessments: Weeks 12, 16, 20, and 24. Participants with resected index or new lesions considered progressed in their disease. The immune-related (ir) response criteria (irRC) represents further modifications of mWHO criteria reflecting clinical experience with ipilimumab in which objective and durable responses (as per mWHO) were observed in participants following progression and without intervening alternative anti-cancer therapy. Immune-related (ir)Complete Response (irCR): Complete disappearance of all index lesions; ir Partial Response (irPR): Decrease, relative to baseline, of 50% or greater in sum of products of the two largest perpendicular diameters of all index and all new measurable lesions, in the absence of irCR; ir Stable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (PD); ir PD: At least 25% increase in Tumor Burden compared to sum of product diameters (SPD) at nadir. ir Unknown=participants overall response not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102075|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Modified World Health Organization (mWHO) Criteria - All Treated Participants|Assessments for antitumor activity by physical exam and routine anatomic imaging were at Week 12 and confirmatory imaging at Weeks 16, 20, and 24. Participants with resected index or new lesions were considered progressed in their disease. Complete Response (CR): Complete disappearance of all index lesions; Partial Response (PR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease (SD): Does not meet criteria for complete or partial response, in the absence of progressive disease. Participants with PR or CR that was not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions; Progressive Disease: At least 25% increase in the sum of products of all index lesions and/or the appearance of any new lesion(s). Unknown=the participants overall response was not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.||participants|||Number
102076|NCT00796991|Secondary|Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Vss reported in liters(L): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||L||Geometric Coefficient of Variation|Geometric Mean
102077|NCT00796991|Primary|Area Under the Concentration Time Curve (AUC) From Time Zero to 21 Days [AUC(0-21d)] for Ipilimumab and AUC Time Zero Extrapolated to Infinity [AUC(INF)] for Paclitaxel, Dacarbazine and the Active Metabolite AIC - Pharmacokinetic Analysis Population|AUC=micrograms*hour(h) per mL (µg*h/mL): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
102078|NCT00796991|Secondary|Pharmacokinetic Parameter of Clearance (CLT) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|CLT reported in milliliters/hour (mL/h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||mL/h||Geometric Coefficient of Variation|Geometric Mean
102079|NCT00796991|Secondary|Pharmacokinetic Parameter of Terminal Elimination Half Life (T-HALF) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|T(HALF) reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||h||Standard Deviation|Mean
102080|NCT00796991|Secondary|Pharmacokinetic Parameter of Time of Maximum Observed Concentration (Tmax) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Tmax reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||h||Full Range|Median
102081|NCT00796991|Primary|Pharmacokinetic Parameter Maximum Observed Serum Concentration (Cmax) for Ipilimumab, Paclitaxel, Dacarbazine and the Active Metabolite for Dacarbazine, 5-aminoimidazole-4carboxamide (AIC)- Pharmacokinetic Analysis Population|Cmax=micrograms per milliliter (µg/mL): drug concentration versus time for ipilimumab (Day 43) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma by Enzyme-linked Immunosorbent Assay (ELISA); lower level of quantitation (LLOQ)=0.8 µg/mL; upper limit of quantitation (ULOQ)=25.6 µg/mL; Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; from Day 162 on every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined using liquid chromatography tandem mass spectrometry (LC/MS/MS) detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography atmospheric pressure ionization (API) tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate Pharmacokinetic (PK) profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
102082|NCT00796926|Secondary|Superior and Inferior Tear Meniscus Height|This is determined by anterior segment OCT visante system|6 weeks||||||
102083|NCT00796926|Secondary|Tear Osmolarity|This is measured by the TearLab (Ocusense) system|6 weeks||||||
102084|NCT00796926|Secondary|Meibography Grading||6 weeks||||||
102085|NCT00796926|Secondary|Schirmer I Reading||6 weeks||||||
102086|NCT00796926|Secondary|Tear Break Up Time (TBUT)||6 weeks||||||
102093|NCT00796822|Primary|Change in Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.|Measured at baseline and Week 8|Number of remaining participants at week 8 with evaluable vascular ultrasonography. In the Pentoxifylline group, 10 participants were evaluated at week 8 but only 9 had evaluable ultrasonography.||absolute percentage||Standard Deviation|Mean
102094|NCT00796757|Secondary|EQ-5D - Visual Analog Scale (VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
102095|NCT00796757|Secondary|Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
102096|NCT00796757|Secondary|OS - Time to Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population||months||95% Confidence Interval|Median
102097|NCT00796757|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population||percentage of participants|||Number
102098|NCT00796757|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months|OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population||percentage of participants||95% Confidence Interval|Number
102099|NCT00796757|Primary|PFS - Time to Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population||months||95% Confidence Interval|Median
102100|NCT00796757|Primary|PFS - Percentage of Participants With an Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population||percentage of participants|||Number
102101|NCT00796757|Secondary|Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)|Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population; only participants with measurable disease were included in the analysis.||percentage of participants|||Number
102102|NCT00796757|Primary|Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|12 and 24 months|ITT population||percentage of participants||95% Confidence Interval|Number
102103|NCT00796744|Secondary|The Time to Re-epithelialization of the Ulcer Site.|Average time to complete re-epithelialization of baseline ulcer area.|24 weeks|||Weeks||Standard Error|Mean
102108|NCT00796718|Secondary|Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 15 weeks (assessed 1 month after surgery)|Participants with available data.||percentage of participants|||Number
102109|NCT00796718|Secondary|Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)|Participants with available data.||percentage of participants|||Number
102110|NCT00796718|Primary|Percentage of Participants With Pathological Complete Response|Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.|Up to 11 weeks (assessed at the time of post-treatment surgery)|Participants with available data.||percentage of participants|||Number
102111|NCT00796705|Secondary|Participants With an ACR 70 Response at Week 12|"The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat||participants|||Number
102112|NCT00796705|Secondary|Participants With an ACR 50 Response at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat||participants|||Number
102113|NCT00796705|Secondary|Participants With an ACR 20 Response at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat||participants|||Number
102114|NCT00796705|Secondary|Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)|The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2.|Baseline, Week 12|Intent-to-treat||participants|||Number
102115|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat||participants|||Number
102116|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat||participants|||Number
102117|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat||Scores on a scale||Standard Deviation|Mean
102118|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat||Scores on a scale||Standard Deviation|Mean
102119|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102120|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102121|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102122|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102123|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102124|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Vitality score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102125|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102126|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102127|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102128|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 and ET|ITT; N=number of participants analyzed||units on a scale||Standard Deviation|Mean
102129|NCT00796666|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48|WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X.|Baseline, Weeks 12, 24 or ET|ITT||participant|||Number
102130|NCT00796666|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline.|Baseline to Weeks 12 and 24|ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) method||meters (m)||Standard Deviation|Mean
102131|NCT00796666|Primary|Time to Clinical Worsening (TTCW)|Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study’s first dose date in and date when first clinical worsening event occurs.|Baseline, Weeks 12, 24 or Early Termination (ET)|Intent-to-Treat population (ITT): all participants who were randomized||Days||Full Range|Median
102132|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Mean
102133|NCT00796653|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first study drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
102134|NCT00796653|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.||percentage of participants|||Number
102135|NCT00796653|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
102136|NCT00796653|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
102137|NCT00796653|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
102138|NCT00796653|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|||Days||95% Confidence Interval|Mean
102139|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|||Days||95% Confidence Interval|Mean
102140|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|||Days||95% Confidence Interval|Mean
102141|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102142|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102209|NCT00796549|Secondary|Duration of Confirmed Disease Control|Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).||Weeks||Standard Deviation|Mean
102143|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102144|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102145|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102146|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102147|NCT00796653|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102148|NCT00796653|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102149|NCT00796653|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102150|NCT00796653|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102151|NCT00796653|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS||Number of puffs||Standard Error|Mean
102152|NCT00796653|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS||L/min||Standard Error|Mean
102153|NCT00796653|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102162|NCT00796653|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
102154|NCT00796653|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102155|NCT00796653|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102156|NCT00796653|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102157|NCT00796653|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102158|NCT00796653|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
102159|NCT00796653|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
102160|NCT00796653|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
102161|NCT00796653|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
102194|NCT00796614|Secondary|Post Void Residual Volume at Week 14|Median change from baseline to Week 14 in post void residual (mL) by study treatment.|Baseline and Week 14.|Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.||mL||Standard Deviation|Median
102163|NCT00796653|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
102164|NCT00796653|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
102165|NCT00796653|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
102166|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102167|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102168|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102169|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102206|NCT00796549|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.|Day 15|"Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data.~Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
102170|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102171|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102172|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102173|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102174|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102175|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102176|NCT00796653|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
102207|NCT00796549|Secondary|Overall Survival (OS) Time|Overall survival time is defined as time from the date of start of treatment to the date of death.|Baseline until last vital status assessment 17JUN13|Treated set (TS).||Weeks||95% Confidence Interval|Median
102208|NCT00796549|Secondary|Progression Free Survival (PFS) Time|Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).||Weeks||95% Confidence Interval|Median
102177|NCT00796653|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
102178|NCT00796653|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
102179|NCT00796653|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
102180|NCT00796653|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
102181|NCT00796653|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
102182|NCT00796653|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
102183|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102184|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102546|NCT00793793|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).|week 48|FAS||percentage of responders|||Number
102185|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102186|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102187|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102188|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102189|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102190|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102191|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102192|NCT00796653|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
102193|NCT00796653|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102195|NCT00796614|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.|"Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.~Relevant findings or worsening of baseline conditions were reported as adverse events."|From first drug administration until 28 days after last study drug administration, upto 160 days|"Treated Set (TS).~All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study."||Participants|||Number
102196|NCT00796614|Secondary|Change From Baseline in Number of Times Patient Was Wet at Catheterisation|Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH)||Times patient wet at catheterization||Standard Error|Least Squares Mean
102197|NCT00796614|Secondary|Change From Baseline in Urine Volume at Week 14|Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.||mL||Standard Error|Least Squares Mean
102198|NCT00796614|Secondary|Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline|"Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).~Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14."|Baseline and Week 14|Full analysis set-renal (FAS-RENAL)||Participants|||Number
102199|NCT00796614|Secondary|Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline|"Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.~The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization"|Baseline and Week 14|Full analysis set-renal (FAS-RENAL): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.||Participants|||Number
102200|NCT00796614|Secondary|Percentage Change From Baseline in LPP at Week 14 (End of Treatment)|Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.|Baseline and Week 14.|Full analysis set-LPP (FAS-LPP), OT||Percentage change||Standard Error|Least Squares Mean
102201|NCT00796614|Secondary|Change From Baseline in LPP at Week 14 (End of Treatment)|Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.|Baseline and Week 14|Full analysis set-LPP (FAS-LPP), OT||cm H2O||Standard Error|Least Squares Mean
102202|NCT00796614|Primary|Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.|The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.|Week 14|Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.||Percentage of participants|||Number
102203|NCT00796549|Secondary|Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status|"Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :~0 : Fully active, able to carry on all pre-disease performance without restriction.~: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.~: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.~: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.~: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.~: Dead.~Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included."|End Of Treatment, up until 190 weeks|Treated set (TS).||percentage of participants|||Number
102204|NCT00796549|Secondary|Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction|"Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.~There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF)."|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).||percentage of participants|||Number
102205|NCT00796549|Secondary|Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder|The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs.|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).||Percentage of participants|||Number
102210|NCT00796549|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).||percentage of participants||95% Confidence Interval|Number
102211|NCT00796549|Secondary|Duration of Confirmed Objective Response (OR)|Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).||Weeks||Standard Deviation|Mean
102212|NCT00796549|Secondary|Number of Participants With Objective Response (OR) Categorized by Time|Cumulative number of participants with objective response by time points with responders.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).||percentage of participants|||Number
102213|NCT00796549|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||percentage of participants||95% Confidence Interval|Number
102214|NCT00796523|Primary|Hours Per Day of Sleep|mean sleep time is the mean of 3 daily sleep times reported in a time period.|week 8|Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis||hours per day||Standard Deviation|Mean
102215|NCT00796523|Primary|Hours Per Day of Fuss/Cry|total hours per day of fuss, cry, and unsoothable crying.|week 8|If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis||hours per day||Standard Deviation|Mean
102216|NCT00796523|Secondary|Parenting Stress Index|a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.|week 6|results based on ITT; 16 subjects did not complete any diaries or data collection instruments and are not included in the analysis||points on a scale||Standard Deviation|Mean
102217|NCT00796510|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)|The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).|Baseline, Week 12 and ET (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||participants|||Number
102218|NCT00796510|Secondary|Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24|The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.|Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||meters||Standard Deviation|Mean
102219|NCT00796510|Primary|Overall Survival|Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.|Baseline and every 12 weeks up to Week 18|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.||weeks||Standard Deviation|Mean
102220|NCT00796367|Primary|Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.||Baseline to End of Treatment|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent participants|||Number
102221|NCT00796367|Primary|Percent Weight Change at End of Treatment, Week 108.||From baseline to end of treatment|Intent-to-Treat Last observation carried forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
102222|NCT00796328|Primary|Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension|The effective dose at which 90% of subjects will have a “positive” response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 – 60 mcg/min.|Spinal administration until delivery|||dose of phenylephrine|||Number
102223|NCT00796315|Primary|Cmax of Doxylamine|Maximum concentration of Doxylamine from 0 to 72 hours post-dose|72 Hours|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
102224|NCT00796315|Primary|AUC of Doxylamine|Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.|72 Hours|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
102225|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Severity of Illness|Using this clinician rating scale the severity of the illness is scored from 1= normal to 7= extremely ill. This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Severity of Illness scores are reported below.|Measured at endpoint visit|ADHD and severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Severity of Illness rating||participants|||Number
102226|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Improvement|Using this clinician rating scale the patient's improvement is scored on a 7-point scale which ranges from “very much improved” (1), through “no change” (4), to “very much worse” (7). This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Improvement scores are reported below.|Measured at endpoint visit|ADHD & severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Improvement rating||participants|||Number
102227|NCT00796302|Other Pre-specified|Antisocial Behavior Scale - Reactive Aggression Subscale|The Antisocial Behavior Scale (ABS) is a 28-item scale that contains 10 Proactive Aggression items and six Reactive Aggression items. Each item is rated on a 3-point scale, ranging from 1 (Never) to 3 (Very often). Thus, scores on the Reactive Aggression subscale can range from 6 through 18; with higher scores indicating more reactive aggression.|Measured at baseline and Week 9|ADHD & severe physical aggression||units on a scale||Standard Deviation|Mean
102260|NCT00795951|Primary|Diagnostic Performance: Imidazolidinyl Urea|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
102228|NCT00796302|Primary|NCBRF-TIQ D-Total Score|"Parent ratings of aggression and hostility on the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ) D-Total Score. The NCBRF provides 1 prosocial subscale (Positive/Social) and 6 problem behavior subscales (Conduct Problem, Oppositional Behavior, Hyperactive, Inattentive, Overly Sensitive, and Withdrawn/Dysphoric). The NCBRF has excellent internal consistency, distinguishes between controls and subjects with DBDs. Conduct Problem and Oppositional Behavior subscales map closely to DSM-IV-TR symptoms of CD and ODD; they were scored together to form a variable called the D-Total.~For the NCBRF D-Total, higher scores reflect worse behavior. Each subscale is scored by taking the rating (0 [did not occur or was not a problem] to 3 [occurred a lot or was a very severe problem]) for all component items. The D-Total score was computed by adding the 6 scores from the Oppositional subscale and the 10 items from the Conduct Problem subscale. Thus D-Total scores could range from 0-69."|Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9|ADHD & severe physical aggression||units on a scale||Standard Deviation|Mean
102229|NCT00796224|Secondary|Adverse Events (AEs) and Serious AEs (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.|Baseline up to 28 days|All subjects who received at least 1 dose of study medication were included in the safety analyses.||participants|||Number
102230|NCT00796224|Secondary|Number of Participants With a Clinical Response|"Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following:~Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary;~New clinical signs and symptoms of acute illness have developed and additional therapy is necessary"|Days 7,8,9 or 10|Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events.||participants|||Number
102231|NCT00796224|Secondary|Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)||1,2,3,4,8,24,48,72 hours postdose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/ml|||Number
102232|NCT00796224|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||hr||Full Range|Median
102233|NCT00796224|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azithromycin||Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/ml||Standard Deviation|Mean
102234|NCT00796224|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)|AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng*hr/ml||Standard Deviation|Mean
102235|NCT00796224|Primary|Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)|AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.|Predose/0 to 72 Hours|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng*hr/ml||Standard Deviation|Mean
102236|NCT00796120|Secondary|Duration of Response (DOR)|The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.|Up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||days||95% Confidence Interval|Median
102237|NCT00796120|Secondary|Overall Survival|Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline up to End of Study (an average of 4 years)|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.||months||95% Confidence Interval|Median
102238|NCT00796120|Secondary|Percentage of Participants With Objective Response|Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.||percentage of participants||95% Confidence Interval|Number
102239|NCT00796120|Secondary|6-month Progression - Free Survival|Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.|6 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.||percentage of participants||95% Confidence Interval|Number
102240|NCT00796120|Primary|Progression - Free Survival (PFS)|The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)||months||95% Confidence Interval|Median
102241|NCT00796003|Secondary|Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial)|IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases. IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality.|Up to 1.5 years after the last participant enrolled|20 participants who had chromosomal abnormality were evaluated in Phase II for cytogenetic response. The IWG criteria requires 20 analyzable metaphases using conventional cytogenetic techniques.||Participants|||Number
102242|NCT00796003|Secondary|Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 1.5 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this set||Participants|||Number
102243|NCT00796003|Secondary|Phase II: Median Duration of Overall Improvement|Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement).|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.||Days||Full Range|Median
102244|NCT00796003|Secondary|Phase II: Median Duration of Remission|Median time duration for which participants achieved remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.||Days||Full Range|Median
102245|NCT00796003|Secondary|Phase II: Median Time to Improvement|Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement)|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.||Days||95% Confidence Interval|Median
102246|NCT00796003|Secondary|Phase II: Median Time to Remission|Median time required for the participants to achieve remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.||Days||95% Confidence Interval|Median
102247|NCT00796003|Secondary|Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 28 Days of treatment Cycle 1|Full Analysis Set (FAS): 9 participants were included in this set for Phase I||Participants|||Number
102248|NCT00796003|Secondary|Phase I: Area Under the Plasma Concentration-time Curve (AUC)|Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last).|Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis||ng*h/mL||Standard Deviation|Mean
102249|NCT00796003|Secondary|Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax)||Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis||ng/mL||Standard Deviation|Mean
102250|NCT00796003|Primary|Phase I and II: Number of Participants Who Experienced Adverse Events||Up to 1.5 years after the last participant enrolled|Safety Population: 9 participants in Phase I and 34 participants in Phase II were evaluated for safety||Participants|||Number
102251|NCT00796003|Primary|Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.|Up to 1 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this analysis set for Phase II||Participants|||Number
102252|NCT00795951|Secondary|Itching/Burning|Number of subjects who presented with itching/burning at patch removal|Day 2: 48 hours after patch application|||participants|||Number
102253|NCT00795951|Secondary|Adhesion|Number of subjects who presented with poor adhesion at patch removal|Day 2: 48 hours after application|||participants|||Number
102254|NCT00795951|Secondary|Irritation|Number of subjects who presented with irritation at patch removal|Visit 2: 48 hours after patch application|||participants|||Number
102255|NCT00795951|Secondary|Persistent Reactions|Number of subjects who presented with persistent reactions|appear 2-4 days after patch application and last through 7-14 days after application|||participants|||Number
102256|NCT00795951|Secondary|Late Reactions|Number of subjects who presented with late reactions|7-10 days after patch application|||participants|||Number
102257|NCT00795951|Primary|Diagnostic Performance: Quinoline Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
102258|NCT00795951|Primary|Diagnostic Performance: Tixocortol-21-pivalate|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
102259|NCT00795951|Primary|Diagnostic Performance: Budesonide|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|||participants|||Number
102284|NCT00795951|Primary|Diagnostic Performance: Neomycin Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|The prevalence of allergic contact dermatitis varies greatly (≤1%-10%) in consecutive subjects. Therefore, estimates of sample size and study power are based on overall AE rates, which are generally similar across populations and test allergens and for which there is relevant historical data.||participants|||Number
102285|NCT00795951|Primary|Diagnostic Performance: Nickel Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All completed subjects were included in the efficacy analysis.||participants|||Number
102286|NCT00795886|Primary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation. The Kaplan-Meier product limit method was used to compute the probability of overall survival to 2 years. Greenwood's formula was used to compute the standard error.|24 months after transplant|All patients enrolled in study.||probability||Standard Error|Mean
102287|NCT00795886|Secondary|Percentage of Patients Developing Acute Graft vs. Host Disease (GVHD)|Cumulative incidence of Grade 2-4 acute GVHD at 180 days.|180 days|||percentage of participants||95% Confidence Interval|Number
102288|NCT00795886|Primary|Number of Participants With Transplant-related Mortality|Death not associated with relapse. We determined that if transplant related mortality(TRM) 25% at day 100 or if Grade III-IV (severe, life threatening, or disabling) acute GVHD was >30% a stopping rule would be triggered.|24 months after transplant|All participants enrolled in the trial.||participants|||Number
102289|NCT00795717|Secondary|Brachial Artery Reactivity|"To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.~Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of % of brachial artery."|12 weeks|||% of brachial artery diameter||Standard Deviation|Mean
102290|NCT00795717|Secondary|Serum HDL Level||12 weeks|||mg/dl||Standard Deviation|Mean
102291|NCT00795717|Primary|Change in Baseline Mean Serum Triglyceride Level at Study End|Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo|Baseline and 12 weeks|Randomized, cross over design||mg/dl||Standard Deviation|Mean
102292|NCT00795704|Secondary|Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages|2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.|Baseline and 3 months|Intention-to-treat with data submitted baseline and final.||mg/dL||Standard Deviation|Mean
102293|NCT00795704|Secondary|Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels|Sodium (>150 mmol/L), Potassium (>5 mmol/L), Bicarbonate (>34 mmol/L), Chloride (>110 mmol/L), Serum Creatinine (>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (>11 mg/L), Alanine Aminotransferase (>3 times baseline), Aspartate Aminotransferase (>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported.|Baseline, 1 month, and 3 months|||participants|||Number
102294|NCT00795704|Primary|Hemoglobin A1C||3 month minus baseline|intention-to-treat||percent||Standard Deviation|Mean
102295|NCT00795639|Secondary|Time to Clinical Worsening (TTCW)|TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.|Baseline, Weeks 4, 8 and 12 or ET|ITT; N=number of participants with analyzable data||days||Full Range|Median
102296|NCT00795639|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12|WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.|Baseline, Weeks 4, 8 and 12 or Early Termination (ET)|ITT; N=number of participants with analyzable data; n=number of participants with analyzable data at the specific time point||participants|||Number
102297|NCT00795639|Primary|Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.|Baseline/Day 1 and Week 12|Intent to treat population (ITT): all participants who were randomized; missing value at Week 12 imputed with last non-missing value, including the non-missing value obtained at early termination based on last observation carried forward (LOCF)||Meters (m)||Full Range|Median
102298|NCT00795600|Secondary|Number of Non-serious Adverse Events|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.||events|||Number
102299|NCT00795600|Secondary|Number of Hypoglycaemic Episodes|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.||episodes|||Number
102300|NCT00795600|Secondary|Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects from the Insulin Detemir group and one subject from the Insulin NPH group did not show a PAI-1 available value at week 0. Three subjects from each treatment group did not present a PAI-1 available value at week 26.||ng/L||Standard Error|Least Squares Mean
102317|NCT00795600|Secondary|Absolute Change in Neutrophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.||percentage||Standard Deviation|Mean
102301|NCT00795600|Secondary|Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)|Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject from each treatment group did not present a hsCRP available value at week 0. Two subjects from the Insulin Detemir group and three subjects from the Insulin NPH group did not show a hsCRP available value at week 26.||mg/L||Standard Error|Least Squares Mean
102302|NCT00795600|Secondary|Absolute Change in Hip Circumference|Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in hip circumference at week 26.||cm||Standard Error|Least Squares Mean
102303|NCT00795600|Secondary|Absolute Change in Waist Circumference|Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in waist circumference at week 26.||cm||Standard Error|Least Squares Mean
102304|NCT00795600|Secondary|Absolute Change in Body Weight|Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in body weight at week 26.||kg||Standard Error|Least Squares Mean
102305|NCT00795600|Secondary|Absolute Change in Potassium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Potassium at week 26.||mmol/L||Standard Deviation|Mean
102306|NCT00795600|Secondary|Absolute Change in Sodium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Sodium at week 26.||mmol/L||Standard Deviation|Mean
102307|NCT00795600|Secondary|Absolute Change in Alkaline Phosphatase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the Alkaline Phosphatase at week 26.||IU/L||Standard Deviation|Mean
102308|NCT00795600|Secondary|Absolute Change in Aspartate Aminotransferase (ASAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ASAT at week 26.||IU/L||Standard Deviation|Mean
102309|NCT00795600|Secondary|Absolute Change in Alanine Aminotransferase (ALAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ALAT at week 26.||IU/L||Standard Deviation|Mean
102310|NCT00795600|Secondary|Absolute Change in Bilirubin Total||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Bilirubin Total at week 26.||mg/dL||Standard Deviation|Mean
102311|NCT00795600|Secondary|Absolute Change in Albumin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the albumin at week 26.||mg/dL||Standard Deviation|Mean
102312|NCT00795600|Secondary|Absolute Change in Urea||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Urea at week 26.||mg/dL||Standard Deviation|Mean
102313|NCT00795600|Secondary|Absolute Change in Creatine Phosphokinase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatine Phosphokinase at week 26.||IU/L||Standard Deviation|Mean
102314|NCT00795600|Secondary|Absolute Change in Creatinine||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatinine at week 26.||mg/dL||Standard Deviation|Mean
102315|NCT00795600|Secondary|Absolute Change in Basophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.||10^9 cells/L||Standard Deviation|Mean
102316|NCT00795600|Secondary|Absolute Change in Eosinophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.||10^9 cells/L||Standard Deviation|Mean
102378|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population||msec|||Number
102318|NCT00795600|Secondary|Absolute Change in Monocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Monocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.||percentage||Standard Deviation|Mean
102319|NCT00795600|Secondary|Absolute Change in Lymphocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Lymphocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.||percentage||Standard Deviation|Mean
102320|NCT00795600|Secondary|Absolute Change in Leucocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Leucocytes at week 26.||10^9 cells/L||Standard Deviation|Mean
102321|NCT00795600|Secondary|Absolute Change in Erythrocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Erythrocytes at week 26.||percentage||Standard Deviation|Mean
102322|NCT00795600|Secondary|Absolute Change in Thrombocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subjects in the Insulin Detemir group presented values at week 26 in thrombocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.||percentage||Standard Deviation|Mean
102323|NCT00795600|Secondary|Absolute Change in Blood Volume (Haematocrit)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the Haematocrit at week 26.||percentage||Standard Deviation|Mean
102324|NCT00795600|Secondary|Absolute Change in Haemoglobin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the haemoglobin at week 26.||g/dL||Standard Deviation|Mean
102325|NCT00795600|Secondary|Absolute Change in Free Fatty Acids||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the free fatty acids at week 26.||mg/dL||Standard Deviation|Mean
102326|NCT00795600|Secondary|Absolute Change in Triglycerides||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and six patients in the Insulin NPH group did not present a value in the triglycerides at week 26.||mg/dL||Standard Deviation|Mean
102327|NCT00795600|Secondary|Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and seven patients in the Insulin NPH group did not present a value in the VLDL cholesterol at week 26.||mg/dL||Standard Deviation|Mean
102328|NCT00795600|Secondary|Absolute Change in Low Density Lipoprotein (LDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the LDL cholesterol at week 26.||mg/dL||Standard Deviation|Mean
102329|NCT00795600|Secondary|Absolute Change in High Density Lipoprotein (HDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the HDL cholesterol at week 26.||mg/dL||Standard Deviation|Mean
102330|NCT00795600|Secondary|Absolute Change in Total Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the total cholesterol at week 26.||mg/dL||Standard Deviation|Mean
102331|NCT00795600|Secondary|Absolute Change in Adiponectin|Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Six subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the adiponectin at week 26.||mcg/dL||Standard Error|Least Squares Mean
102332|NCT00795600|Secondary|Absolute Change in Fasting Plasma Glucose (FPG)|Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and six subjects in the Insulin NPH group did not present a value in the fasting plasma glucose at week 26.||mg/dL||Standard Error|Least Squares Mean
102333|NCT00795600|Secondary|Absolute Change in HbA1c (Glycosylated Haemoglobin)|Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the hbA1c at week 26.||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
102334|NCT00795600|Secondary|Percentage Change in Liver/Spleen Attenuation Ratio|Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.||percent change||Standard Error|Least Squares Mean
102335|NCT00795600|Secondary|Absolute Change in Liver/Spleen Attenuation Ratio|Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.||ratio||Standard Error|Least Squares Mean
102336|NCT00795600|Secondary|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.||percent change||Standard Error|Least Squares Mean
102337|NCT00795600|Secondary|Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.||ratio||Standard Error|Least Squares Mean
102338|NCT00795600|Secondary|Percentage Change in Subcutaneous Adipose Tissue Area|Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.||percent change||Standard Error|Least Squares Mean
102339|NCT00795600|Secondary|Absolute Change in Subcutaneous Adipose Tissue Area|Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.||cm^2||Standard Error|Least Squares Mean
102340|NCT00795600|Secondary|Percentage Change in Visceral Adipose Tissue Area|Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.||percent change||Standard Error|Least Squares Mean
102341|NCT00795600|Secondary|Absolute Change in Visceral Adipose Tissue Area|Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.||cm^2||Standard Error|Least Squares Mean
102342|NCT00795600|Secondary|Percentual Change in Calculated Trunk Fat Percentage|Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.||percent change||Standard Error|Least Squares Mean
102343|NCT00795600|Secondary|Absolute Change in Calculated Trunk Fat Percentage|Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.||percent of trunk fat (%)||Standard Error|Least Squares Mean
102344|NCT00795600|Secondary|Percentual Change in Calculated Whole Body Fat Percentage|Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.||percent change||Standard Error|Least Squares Mean
102345|NCT00795600|Secondary|Absolute Change in Calculated Whole Body Fat Percentage|Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.||percent of whole body fat (%)||Standard Error|Least Squares Mean
102346|NCT00795600|Secondary|Percentage Change in Trunk Lean Mass|Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.||percent change||Standard Error|Least Squares Mean
102547|NCT00793793|Secondary|Complete EVR2 (cEVR2)|VL below the limit of detection at both 4 weeks and 12 weeks|week 4 and week 12|FAS||percentage of responders|||Number
102347|NCT00795600|Secondary|Absolute Change in Trunk Lean Mass|Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.||grams (g)||Standard Error|Least Squares Mean
102348|NCT00795600|Secondary|Percentage Change in Whole Body Lean Mass|Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.||percent change||Standard Error|Least Squares Mean
102349|NCT00795600|Secondary|Absolute Change in Whole Body Lean Mass|Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.||grams (g)||Standard Error|Least Squares Mean
102350|NCT00795600|Secondary|Percentage Change in Whole Body Fat Mass|Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.||percent change||Standard Error|Least Squares Mean
102351|NCT00795600|Secondary|Absolute Change in Whole Body Fat Mass|Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.||grams (g)||Standard Error|Least Squares Mean
102352|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.||grams (g)||Standard Error|Least Squares Mean
102353|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.||grams (g)||Standard Error|Least Squares Mean
102354|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.||percent change||Standard Error|Least Squares Mean
102355|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.||percent change||Standard Error|Least Squares Mean
102356|NCT00795535|Primary|SDNN: Standard Deviation of the Normal-to-normal R-R Interval|A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.|Upon arrival to the hospital|||milliseconds (ms)||Standard Deviation|Mean
102357|NCT00795535|Primary|Life Saving Intervention in the Operating Room.|A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data||participants|||Number
102358|NCT00795535|Primary|Serious Injury|A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data||participants|||Number
102359|NCT00795535|Primary|Base Deficit </= -6|Indicator for volume deficit and resuscitation. Number of participants with Base Deficit </= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit </= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data||participants|||Number
102379|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population||msec|||Number
102360|NCT00795509|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.||participants|||Number
102361|NCT00795509|Primary|Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.||participants|||Number
102362|NCT00795366|Primary|Time ICP >20|The number of hours that participants remained with intracranial pressure above 20 mmHg|The number of hours during the first 5 days of intracranial pressure monitoring|Intent-to-Treat||Hours||Standard Deviation|Mean
102363|NCT00795340|Secondary|Objective Tumor Response as Assessed by RECIST Criteria v1.1.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|ITT||percentage of participants||95% Confidence Interval|Number
102364|NCT00795340|Secondary|Progression-free Survival|Medians of PFS and their confidence intervals by arm|at every 3 months visit throughout trial, a median of 12 months|ITT||months||95% Confidence Interval|Median
102365|NCT00795340|Primary|Overall Survival|Medians of survival time, and their confidence intervals.|at every 3 months visit throughout trial, a median of 13.1 months.|ITT||months||95% Confidence Interval|Median
102366|NCT00795288|Secondary|Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk|Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.|7-10 days after hemorrhage|||ratio||Standard Deviation|Mean
102367|NCT00795288|Primary|Cerebral Autoregulation During Peak Period of Vasospasm Risk|Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.|7-10 days after hemorrhage|||participants|||Number
102368|NCT00795288|Primary|Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk|Resting cerebral blood flow during peak period of vasospasm risk measured by PET|7-10 days after hemorrhage|"Of the total population enrolled complete data sets were available on 25. This was due to patient refusal to perform the PET study, logistical difficulties and technical problems.~be completed in seven due to logistical difficulties (n = 4) or patient refusal (n = 3). Two of the completed studies could not be analyzed for technical reasons"||mL/100 g/min||Standard Deviation|Mean
102369|NCT00795210|Secondary|Insulin Sensitivity|"insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; M value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given"|after two weeks treatment|Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used.||mg/kg/min||Standard Deviation|Mean
102370|NCT00795210|Primary|Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug|Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.|after 2 weeks treatment|Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.||ng/mL||Inter-Quartile Range|Median
102371|NCT00795184|Primary|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Centralized histopathology confirmation within 4-6 weeks|||percentage of lesions|Participants|95% Confidence Interval|Number
102372|NCT00795145|Secondary|Cohort 2: Number of Subjects With AEs and SAEs|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|SAS||participants|||Number
102373|NCT00795145|Secondary|Cohort 2: Vss|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||L/kg||Standard Deviation|Mean
102374|NCT00795145|Secondary|Cohort 2: CL|Drug clearance = Dose / AUC inf|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||mL/min/kg||Standard Deviation|Mean
102375|NCT00795145|Secondary|Cohort 2: Tmax and t1/2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax.|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||hr||Full Range|Median
102376|NCT00795145|Secondary|Cohort 2: Cmax||Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||ug/mL||Standard Deviation|Mean
102377|NCT00795145|Secondary|Cohort 2: AUC Inf and AUC Last|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population||ug *hr/mL||Standard Deviation|Mean
102380|NCT00795145|Primary|Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo|The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia’s formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|The pharmacokinetic (PK) parameter analysis population was defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.||milliseconds (msec)|||Number
102381|NCT00795145|Secondary|Cohort 1: Steady-State Volume of Distribution (Vss)|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||L/kg||Standard Deviation|Mean
102382|NCT00795145|Secondary|Cohort 1: Clearance of Linezolid (CL)|Drug clearance = Dose / AUC inf|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||mL/minute (min)/kilogram (kg)||Standard Deviation|Mean
102383|NCT00795145|Secondary|Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||hr||Full Range|Median
102384|NCT00795145|Secondary|Cohort 1: Maximum Observed Plasma Concentration (Cmax)||predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||ug/mL||Standard Deviation|Mean
102385|NCT00795145|Secondary|Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last)|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population||microgram (ug)*hours (hr)/mL||Standard Deviation|Mean
102386|NCT00795145|Primary|Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|Safety Analysis Set (SAS): All subjects who received at least 1 dose of study medication.||participants|||Number
102387|NCT00795132|Secondary|Number of Participants Who Experienced Transplantation-related Mortality (TRM)|Cumulative incidence transplantation-related mortality (TRM)|24 months|All incidences of enrolled patients were analyzed.||participants|||Number
102388|NCT00795132|Secondary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation.|24 months|All enrolled participants were analyzed.||probability||Standard Error|Mean
102389|NCT00795132|Primary|Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments|Assessed donor engraftment in very high risk pediatric patients.|24 months|All enrolled patients were analyzed except for the 3 patients who relapsed or died prior to engraftment.||participants|||Number
102390|NCT00795002|Secondary|Disease-free Survival|This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.|12 months||||||
102391|NCT00795002|Secondary|Toxicity|as assessed by NCI CTCAE v3.0|1 year||||||
102392|NCT00795002|Primary|Complete Response|Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.|1 year|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy||participants|||Number
102393|NCT00794963|Primary|Change in Weight||baseline and 8 months|4 participants in usual care arm did not return for follow-up and were not available for analysis; 1 participant in the integrated care group was lost to follow-up||pounds||Standard Deviation|Mean
102394|NCT00794924|Secondary|Improvement in Nutritional and Immunological Measurements||45 days||||||
102395|NCT00794924|Primary|Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group|Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.|45 days of measuring the outcome|The number of participants was chosen in order to receive a difference by GEE statistical model with > 0.05 p value. The analysis was done per protocol.||days of constipation or diarrhea||Standard Deviation|Mean
102396|NCT00794820|Secondary|Overall Survival (OS) Rate|OS was defined as the time from the initiation of treatment to last follow-up date or death. OS were calculated using Kaplan-Meier estimates, and survival estimates were compared among subgroups of participants using the log-rank test.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|One of the 65 participants is not included in analysis, the participant went off study after two months of treatment.||Percentage of Participants|||Number
102397|NCT00794820|Secondary|Remission Duration/Time to Progression (TTP)|TTP was defined as time from initiation of treatment to primary refractory disease or CLL progression. TTP was censored for therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) and death in remission. TTP calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.||Months||Full Range|Median
102566|NCT00793624|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.||percentage of participants|||Number
102398|NCT00794820|Primary|Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months|CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter’s transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD.|6 months|One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.||Percentage of Participants|||Number
102399|NCT00794677|Other Pre-specified|Percent Change of Non-high Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
102400|NCT00794677|Other Pre-specified|Percent Change in High Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
102401|NCT00794677|Other Pre-specified|Percent Change of Low Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
102402|NCT00794677|Other Pre-specified|Percent Change of Apolipoprotein B||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||percent||Standard Error|Mean
102403|NCT00794677|Other Pre-specified|Log (AUC of Plasma Triglyceride) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, one subject eliminated because the AUC was negative and cannot be log transformed||Log(mg/dl)||Standard Error|Mean
102404|NCT00794677|Other Pre-specified|Log (AUC of Plasma Total Cholesterol) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, restricted to changes that were nonnegative because there is no log for a negative number||Log(mg/dl)||Standard Error|Mean
102405|NCT00794677|Other Pre-specified|Log(Fasting Plasma Levels of Diet-derived Oxysterols (7-ketocholesterol))||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol||Log(mg/dl)||Standard Error|Mean
102406|NCT00794677|Secondary|Log(Maximal Plasma Concentration (Cmax) of 7-ketocholesterol) After an Oral Bolus|Log Cmax of 7 ketocholesterol after an oral bolus in patients with primary hypercholesterolemia.|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol||Log(mg/dl)||Standard Error|Mean
102407|NCT00794677|Primary|Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus|Log of Area-under-the-plasma-concentration curve (AUC 0-8hrs) of 7-ketocholesterol after an oral bolus in patients with primary hypercholesterolemia after treatment with ezetimibe versus placebo|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|per protocol||Log(mg/dl)||Standard Error|Mean
102408|NCT00794664|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102409|NCT00794664|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102410|NCT00794664|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102411|NCT00794664|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102412|NCT00794664|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||ratio||Inter-Quartile Range|Median
102413|NCT00794664|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
102414|NCT00794664|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102415|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102416|NCT00794664|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102417|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102418|NCT00794664|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102419|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102420|NCT00794664|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102421|NCT00794664|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102422|NCT00794664|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102423|NCT00794664|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102424|NCT00794664|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102425|NCT00794664|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
102426|NCT00794664|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
102427|NCT00794664|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.||percentage of baseline||Standard Deviation|Mean
102428|NCT00794560|Secondary|Patient Satisfaction||at the end of the individual drug therapy, an average of 18 days||||||
102429|NCT00794560|Secondary|Compliance|objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).|at the end of the individual drug therapy, an average of 18 days|||percentage of syringes||Standard Deviation|Mean
102430|NCT00794560|Primary|Drug Use Problems|During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.|during the individual drug therapy, an average of 18 days|||scores on a scale||Standard Deviation|Mean
102431|NCT00794547|Primary|Median Overall Survival|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, overall survival was determined.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.||months||95% Confidence Interval|Median
102432|NCT00794547|Primary|Median Time to Progression|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, median time to progression was determined. Progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.||months||95% Confidence Interval|Median
102433|NCT00794547|Primary|Number of Participants That Experience Grade 3 or Greater Neutropenia|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. Toxicity was assessed, in part, by noting the number of participants that experience grade 3 or greater neutropenia in each phase of the trial. Toxicities were recorded using NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 and were followed for 30 days after the date of withdrawal from study drug.|30 days after last dose|Thirty-four patients were enrolled (18 in phase I and 16 in phase II). 16 of 18 patients enrolled in the Phase 1 portion of the study were evaluable for toxicity. One patient in the phase II study went to another therapy prior to the 30 day window for a confirmatory scan and was thus excluded from analysis.||participants|||Number
102434|NCT00794547|Secondary|To Correlate the Pharmacokinetic Parameters of Systemic Calcitriol Exposure (AUC) With SNPs of the 24-hydroxylase (CYP24), the Major Vitamin D3 Inactivating Enzyme.||3-6 months||||||
102435|NCT00794547|Secondary|To Assess Pharmacokinetics (PK) of Intravenous (IV) Calcitriol in Combination With Cisplatin and Docetaxel During Cycle 1 of the Phase II Part of the Study Using a Validated Limited Sampling Technique.||3-6 months||||||
102436|NCT00794547|Primary|MTD of Intravenous Calcitriol When Administered Prior to Fixed Dose Cisplatin 75mg/m2 and Docetaxel 75 mg/m2, Every 3 Weeks in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)|The primary objective was to determine the Maximum Tolerated Dose (MTD) of intravenous calcitriol when administered prior to fixed dose cisplatin 75mg/m2 and docetaxel 75 mg/m2, every 3 weeks in patients with advanced non-small cell lung cancer (NSCLC). Accrual duration for the study is 5 years.|5 years|Eighteen patients were enrolled, and 16 were evaluable for toxicity assessments. Two patients were not evaluable as they progressed prior to completion of cycle 1.||mcg/m^2|||Number
102437|NCT00794508|Secondary|Number of Participants Reaching the Normal Range of ADA Enzyme Activity|As measured by ADA enzyme activity in peripheral blood mononuclear cells|2 years|||participants|||Number
102438|NCT00794508|Secondary|Number of Participants With Greater Than 1% of Gene-Modified Cells in the Peripheral Blood|As measured by quantitative polymerase chain reaction in peripheral blood cells separated into mononuclear and granulocyte fractions.|2 years|||participants|||Number
102439|NCT00794508|Primary|Number of Participants With Adverse Events|"Examine the safety of the procedure: harvesting bone marrow, isolating CD34+ hematopoietic stem/progenitor cells, performing ex vivo gene transduction with the MND-ADA gamma-retroviral vector, giving 90 mg/m2 busulfan to make space in the bone marrow to aid engraftment, and re-infusing the autologous gene-modified cells."|2 years|||participants|||Number
102440|NCT00794469|Primary|Baseline Metabolic Rate|baseline metabolic rate|baseline|||kcal/d||Standard Deviation|Mean
102441|NCT00794469|Primary|Post-drinking Metabolic Rate|resting metabolic rate after drinking water|1 hour|||kcal/d||Standard Deviation|Mean
102442|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 12|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.||percentage of participants||95% Confidence Interval|Number
102443|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 8|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.||percentage of participants||95% Confidence Interval|Number
102444|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 4|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.||percentage of participants||95% Confidence Interval|Number
102445|NCT00794196|Secondary|Patient Wellbeing|"Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life.~The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health."|0, 3 and 6 months|||units on a scale||95% Confidence Interval|Mean
102446|NCT00794196|Primary|Adherence to Antidepressant Medication|Adherence to antidepressant medication was measured through Pharmacy records|At 3 and 6 months|||percentage of adherence patients||95% Confidence Interval|Number
102447|NCT00794170|Primary|Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)|The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.|Baseline and 12 months|The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.||participants|||Number
102448|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|Prior to last dose at Week 12 (Day 84)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
102449|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 8 (Day 57)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
102450|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 4 (Day 29)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
102451|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 2 (Day 15)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
102452|NCT00794157|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|End of treatment (Week 12 + 1 day, Day 85)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
102453|NCT00794144|Primary|Number of Participants With Anatomic Nasal Exam Abnormalities|The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa|Day 1 (Baseline) to Exit|||Participants|||Number
102454|NCT00794118|Secondary|Indirect Costs|Indirect costs represent the loss of resources as a consequence of work disability or unemployment.|Baseline, Months 3, 6, 9 and 12||08/2012||||
102455|NCT00794118|Secondary|Direct Costs|Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.|Baseline, Months 3, 6, 9 and 12||08/2012||||
102456|NCT00794118|Primary|36-Item Short-Form Health Survey (SF-36) at Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Units on a Scale||Standard Deviation|Mean
102457|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 12|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Units on a Scale||Standard Deviation|Mean
102458|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 9|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
102459|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 6|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
102460|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 3|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
102461|NCT00794118|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||minutes||Standard Deviation|Mean
102462|NCT00794118|Primary|Duration of Morning Stiffness at Month 9|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||minutes||Standard Deviation|Mean
102463|NCT00794118|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||minutes||Standard Deviation|Mean
102464|NCT00794118|Primary|Duration of Morning Stiffness at Month 3|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||minutes||Standard Deviation|Mean
102465|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
102466|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102467|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102468|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102469|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 12|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
102470|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 9|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102471|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 6|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102472|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 3|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102473|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
102474|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102475|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102476|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102477|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Participants|||Number
102478|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 9|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102479|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102480|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 3|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Participants|||Number
102481|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||mm/hr||Standard Deviation|Mean
102482|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 9|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||mm/hr||Standard Deviation|Mean
102483|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||mm/hr||Standard Deviation|Mean
102542|NCT00793793|Secondary|Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time|Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.|from day 1 and up to 4 weeks|FAS||percentage of participants|||Number
102484|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 3|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||mm/hr||Standard Deviation|Mean
102485|NCT00794118|Primary|C-reactive Protein (CRP) at Month 12|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||mg/dL||Standard Deviation|Mean
102486|NCT00794118|Primary|C-reactive Protein (CRP) at Month 9|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||mg/dL||Standard Deviation|Mean
102487|NCT00794118|Primary|C-reactive Protein (CRP) at Month 6|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||mg/dL||Standard Deviation|Mean
102488|NCT00794118|Primary|C-reactive Protein (CRP) at Month 3|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||mg/dL||Standard Deviation|Mean
102489|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 12|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||cm||Standard Deviation|Mean
102490|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 9|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102491|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 6|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102492|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 3|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102493|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||cm||Standard Deviation|Mean
102494|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 9|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102495|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102496|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 3|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102497|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 12|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||cm||Standard Deviation|Mean
102498|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 9|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102499|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 6|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102500|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 3|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||cm||Standard Deviation|Mean
102501|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.||Units on a Scale||Standard Deviation|Mean
102502|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
102503|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
102504|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.||Units on a Scale||Standard Deviation|Mean
102505|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).||Percentage of participants|||Number
102506|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
102507|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
102508|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.|Month 3|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
102509|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
102510|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|3 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
102511|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|day 1 postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
102512|NCT00793910|Secondary|Occurence of Use of Rescue Medication|Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured|2 hours to 4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||# of times rescue meds were used||Standard Deviation|Mean
102513|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|2 hours postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake||units on a scale||Standard Deviation|Mean
102514|NCT00793871|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead).|Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug)|Safety analysis set included all participants who started study treatment.||participants|||Number
102515|NCT00793871|Secondary|Number of Participants With Significant Vital Signs Changes From Baseline|Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline.|Baseline (Day 1) up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.||participants|||Number
103351|NCT00787566|Secondary|Severity of Nausea Measured by a 4 Categorical Scale|4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)|24 hours||||||
102516|NCT00793871|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination.|Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.||participants|||Number
102517|NCT00793871|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.||participants|||Number
102518|NCT00793871|Other Pre-specified|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed.|Baseline (Day 1) to tumor response (up to 82 weeks)|All participants who started study treatment (safety analysis set) had a confirmed objective tumor response.||weeks||95% Confidence Interval|Median
102519|NCT00793871|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0.|Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)|Safety analysis set included all participants who started study treatment.||weeks||95% Confidence Interval|Median
102520|NCT00793871|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline (Day 1) up to end of study treatment (up to 276 weeks)|The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment.||% of participants||95% Confidence Interval|Number
102521|NCT00793871|Secondary|Overall Survival (OS)|"OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause.~In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive."|Baseline (Day 1) to death (up to 282 weeks)|Safety analysis set included all participants who started study treatment.||weeks||95% Confidence Interval|Median
102522|NCT00793871|Primary|Progression-free Survival (PFS)|PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven’t yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)|Safety analysis included all participants who started study treatment.||weeks||95% Confidence Interval|Median
102523|NCT00793819|Primary|Change in Nocturia Episodes||12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||episodes||Standard Deviation|Mean
102524|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAauc data||ratio||Geometric Coefficient of Variation|Geometric Mean
102525|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAcmax data||ratio||Geometric Coefficient of Variation|Geometric Mean
102526|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
102527|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
103352|NCT00787566|Secondary|Number of Emetic Episodes||24 hours||||||
102528|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
102529|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )|PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Vz/F,ss data||L||Geometric Coefficient of Variation|Geometric Mean
102530|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )|PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available CL/F,ss data||mL/min||Geometric Coefficient of Variation|Geometric Mean
102531|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)|PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available MRTpo,ss data||h||Geometric Coefficient of Variation|Geometric Mean
102532|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available t1/2,ss data||h||Geometric Coefficient of Variation|Geometric Mean
102533|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available AUCτ,ss data||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
102534|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)|PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmin,ss data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
102535|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available tmax,ss data||h||Geometric Coefficient of Variation|Geometric Mean
102536|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmax,ss data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
102537|NCT00793793|Secondary|PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)|PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
102538|NCT00793793|Secondary|PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)|PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS||h||Geometric Coefficient of Variation|Geometric Mean
102539|NCT00793793|Secondary|PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)|PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS||ng/mL||Geometric Coefficient of Variation|Geometric Mean
102540|NCT00793793|Secondary|Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period|Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.|from day 1 and up to 4 weeks|TS||percentage of participants discontinued|||Number
102541|NCT00793793|Secondary|Occurrence of AEs, by Action Taken With Regard to Study Medication|Occurrence of AEs, by action taken with regard to study medication.|from day 1 and up to 4 weeks|TS||percentage of participants|||Number
102548|NCT00793793|Secondary|Complete EVR1 (cEVR1)|VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks|week 4 and week 12|FAS||percentage of responders|||Number
102549|NCT00793793|Secondary|Early Virologic Response (EVR)|Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)|week 12|FAS||percentage of responders|||Number
102550|NCT00793793|Secondary|Rapid Virologic Response (RVR)|Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.|week 4|FAS (as randomized)||percentage of responders||95% Confidence Interval|Number
102551|NCT00793793|Secondary|Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients|Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised) including patients with available viral load data.||Log10 IU/mL||Inter-Quartile Range|Median
102552|NCT00793793|Secondary|Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients|Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised)||log10 IU/mL||Inter-Quartile Range|Median
102553|NCT00793793|Primary|Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time|"Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.~ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT)."|Baseline and up to 4 weeks|TS||participants with grade 3 or 4 abnormal|||Number
102554|NCT00793793|Primary|Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period|Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|TS||percentage of participants with SAEs|||Number
102555|NCT00793793|Primary|Occurrence of Adverse Events (AEs) During BI201335 + Washout Period|Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.||percentage of participants with AEs|||Number
102556|NCT00793793|Primary|Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)|Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).|Baseline and up to 4 weeks|Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.||percentage of responders||95% Confidence Interval|Number
102557|NCT00793780|Secondary|Change in Questionnaire on Craving for Sweet or Rich Foods Score|The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.|baseline and week 8|||units on a scale||Standard Deviation|Mean
102558|NCT00793780|Secondary|LDL Cholesterol|Determined by standard enzymatic procedures|baseline and week 8|||mg/dL||Standard Deviation|Mean
102559|NCT00793780|Secondary|Insulin Levels|Determined with a double-antibody radioimmunoassay|baseline and week 8|||microIU/mL||Standard Deviation|Mean
102560|NCT00793780|Secondary|PANSS- Positive and Negative Symptom Scale|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.|8 weeks|||units on a scale||Standard Deviation|Mean
102561|NCT00793780|Secondary|Fasting Serum Glucose Lab Values||baseline and 8 weeks|||mg/dL||Standard Deviation|Mean
102562|NCT00793780|Primary|Change in Body Weight From Baseline|Weight was measured with shoes off to the nearest 0.1 kg.|8 weeks|||kg||95% Confidence Interval|Mean
102563|NCT00793650|Secondary|Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.|"CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.~Partial Response:>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200mg per 24 hour."|100 days after transplant|As per the protocol.||participants|||Number
102564|NCT00793650|Primary|Safety and Engraftment|Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.|Day 30 after transplant|As per the protocol||days||Full Range|Median
102565|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Mean
102567|NCT00793624|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
102568|NCT00793624|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
102569|NCT00793624|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
102570|NCT00793624|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD ex. per patient year||Standard Error|Mean
102571|NCT00793624|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Days||95% Confidence Interval|Mean
102572|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Days||95% Confidence Interval|Mean
102573|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||Days||95% Confidence Interval|Mean
102574|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102575|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102576|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102577|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102578|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102579|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102580|NCT00793624|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102581|NCT00793624|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102582|NCT00793624|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102583|NCT00793624|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102584|NCT00793624|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS||Number of puffs||Standard Error|Mean
102585|NCT00793624|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS||L/min||Standard Error|Mean
102586|NCT00793624|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102587|NCT00793624|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102588|NCT00793624|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102589|NCT00793624|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102590|NCT00793624|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102591|NCT00793624|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
102592|NCT00793624|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
102593|NCT00793624|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
102594|NCT00793624|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
102595|NCT00793624|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
102596|NCT00793624|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
102597|NCT00793624|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
102598|NCT00793624|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
102599|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102600|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102601|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102602|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102603|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102604|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102613|NCT00793624|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS||Liter||Standard Error|Least Squares Mean
102605|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102606|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102607|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102608|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102609|NCT00793624|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS||Liter||Standard Error|Least Squares Mean
102610|NCT00793624|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS||Liter||Standard Error|Least Squares Mean
102611|NCT00793624|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS||Liter||Standard Error|Least Squares Mean
102612|NCT00793624|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS||Liter||Standard Error|Least Squares Mean
102962|NCT00790803|Secondary|Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy|No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.|32 weeks|||participants|||Number
102614|NCT00793624|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS||Liter||Standard Error|Least Squares Mean
102615|NCT00793624|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS||Liter||Standard Error|Least Squares Mean
102616|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102617|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102618|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102619|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102620|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Mean
102670|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
102621|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102622|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102623|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102624|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||score on a scale||Standard Error|Least Squares Mean
102625|NCT00793624|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS||Liter||Standard Error|Least Squares Mean
102626|NCT00793624|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.||Liter||Standard Error|Least Squares Mean
102627|NCT00793611|Secondary|Patient Global Impression of Improvement|Outcome measure is only administered at follow-up and used following treatment in patients with urinary incontinence. Measure varies from 1 to 7 on a Likert scale. 1=very much better and 7=very much worse and 4=no change. Thus, lower numbers represent greater improvement.|6-12 weeks after study initiation (@ completion of intervention)|ITT||units on a scale||Standard Deviation|Mean
102628|NCT00793611|Secondary|Change in Voiding Frequency Based on Voiding Diary|change in mean number of voids per 24 hours. Each participant recorded voiding frequency every 24 hours for 3 days at baseline and follow-up. A mean number of voids for every patient over 24 hours was calculated at baseline and follow-up.|baseline and 6-12 weeks after study initiation|ITT change in mean number of voids/24 hours||number of voids per 24 hours||Standard Deviation|Mean
102629|NCT00793611|Primary|Change in Overactive Bladder Symptoms (Based on OABqSF)|Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.|baseline and approximately 6-12 weeks after study initiation|ITT||units on a scale||Standard Deviation|Mean
102630|NCT00793585|Secondary|The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).||baseline and 6 months|We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.||Upro/cr (mg/g)||Standard Deviation|Mean
102631|NCT00793585|Primary|Change in Renal Function as Measured With eGFR||baseline and 6 months|||eGFR(min/ml)||Standard Deviation|Mean
102632|NCT00793546|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102633|NCT00793546|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102634|NCT00793546|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102635|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) = worst imaginable health state to 100 mm =best imaginable health state; higher scores indicate a better health state.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102636|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102637|NCT00793546|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102638|NCT00793546|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102639|NCT00793546|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 24 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102640|NCT00793546|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102641|NCT00793546|Secondary|Progression Free Survival (PFS) Based on Investigator|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102642|NCT00793546|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety population included all participants who received at least 1 dose of study medication.||percentage of participants|||Number
102643|NCT00793546|Primary|Progression Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.|||||
102644|NCT00793520|Primary|Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.|Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.|Week 0, 5, 7 and 12|||Kg||95% Confidence Interval|Mean
102704|NCT00793169|Primary|The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.||6 hours|Analysis was per protocol.||Participants|||Number
102963|NCT00790803|Secondary|A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye|The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye.|32 weeks|||participants|||Number
102645|NCT00793520|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 & 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient’s right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC|Weeks 0, 5, 7 and 12|||Pain Rating||95% Confidence Interval|Mean
102646|NCT00793455|Secondary|Colorectal Cancer Screening Completion|"We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|6 months post randomization|Analysis was based on intention to treat.||participants|||Number
102647|NCT00793455|Primary|Colorectal Cancer Screening Completion.|"We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|3 months post randomization|Analysis was based on intention to treat.||participants|||Number
102648|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12|SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102649|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6|SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102650|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 12|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102651|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 6|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102652|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 12|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102653|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 6|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102822|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
102654|NCT00793403|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102655|NCT00793403|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102656|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 12|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
102657|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 6|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
102658|NCT00793403|Primary|Patient’s General Health Assessment at Month 12|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102659|NCT00793403|Primary|Patient’s General Health Assessment at Month 6|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102660|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102661|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102662|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm/hour||Standard Deviation|Mean
102663|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mm/hr||Standard Deviation|Mean
102664|NCT00793403|Primary|C-reactive Protein (CRP) at Month 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mg/dL||Standard Deviation|Mean
102665|NCT00793403|Primary|C-reactive Protein (CRP) at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||mg/dL||Standard Deviation|Mean
102666|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 12|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102667|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 6|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102668|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
102669|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
102671|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||cm||Standard Deviation|Mean
102672|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 12|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102673|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 6|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102674|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102675|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102676|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 12|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102677|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 6|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102678|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102679|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Units on a scale||Standard Deviation|Mean
102680|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 12|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102964|NCT00790803|Secondary|Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT)|Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness.|32 weeks|||participants|||Number
102681|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 6|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102682|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102683|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102684|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Joints||Standard Deviation|Mean
102685|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."||Joints||Standard Deviation|Mean
102686|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102687|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102688|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102689|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) <=20 millimeter per hour (mm/hr).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102690|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12|Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC <=1; SJC <=1 (TJC, SJC based on 28-joints); CRP <=1 mg/dL; PtGA<=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had SDAI score of <=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA [assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102705|NCT00793104|Secondary|MRI Evaluation Score|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months|||units on a scale||Standard Deviation|Mean
102691|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6|Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(<=)1;swollen joint count(SJC)<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) <=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had Simplified Disease Activity Index score of <=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment [PGA, assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.|||||
102692|NCT00793325|Primary|Change in Height SD Score for Calendar Age.|The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.||standard deviation (SD) score||Standard Deviation|Mean
102693|NCT00793325|Primary|Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.|Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.||standard deviation (SD) score||Standard Deviation|Mean
102694|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).|To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||Participants|||Number
102695|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.|To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||Participants|||Number
102696|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.|To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||Participants|||Number
102697|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications|To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
102698|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
102699|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.|To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
102700|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
102701|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
102702|NCT00793325|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||events|||Number
102703|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
102706|NCT00793104|Secondary|International Knee Documentation Committee (IKDC) at 24 Months.|The International Knee Documentation Committee scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|||units on a scale||Standard Deviation|Mean
102707|NCT00793104|Secondary|Lysholm With Tegner Score|The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.|24 months|||units on a scale||Standard Deviation|Mean
102708|NCT00793104|Secondary|Current Health Assessment|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0–100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months, MRI only at 12 and 24 months|||units on a scale||Standard Deviation|Mean
102709|NCT00793104|Primary|The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|||units on a scale||Standard Deviation|Mean
102710|NCT00792935|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|"Hypoglycemic episodes are defined as either a fingerstick glucose~measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia."|Baseline to Week 6|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.||participants|||Number
102711|NCT00792935|Primary|Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose|"Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The weighted mean was used to avoid over-representation of post-meal glucose values."|Baseline and Week 6|The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).||mg/dL||95% Confidence Interval|Least Squares Mean
102712|NCT00792805|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized to impute missing data.||Liters||Standard Error|Least Squares Mean
102713|NCT00792688|Secondary|Cosmesis/11-point Likert Scale|The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).|At 1 month following the initial treatment.|||scores on a scale||Standard Deviation|Mean
102714|NCT00792688|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject’s wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.||days||Standard Deviation|Mean
102715|NCT00792636|Secondary|Number of Participants Withdrawn From the Study Due to Blood Pressure Changes|The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart.|Baseline to End of Study (6-month study duration)|ITT Population||participants|||Number
102716|NCT00792636|Secondary|Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||days||Full Range|Median
102717|NCT00792636|Secondary|Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||days||Full Range|Median
102718|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg|The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population||participants|||Number
102719|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study|The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population||participants|||Number
102720|NCT00792636|Secondary|Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||participants|||Number
102721|NCT00792636|Secondary|Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.||participants|||Number
102722|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
102723|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
102724|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
102725|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.||mmHg||95% Confidence Interval|Least Squares Mean
102735|NCT00792259|Primary|Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device|"The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.~Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer"|30 Minutes|||µm||Standard Deviation|Mean
102736|NCT00792116|Primary|Math Grades||14 week (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||average percentage correct||Standard Deviation|Mean
102726|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||mmHg||Standard Deviation|Mean
102727|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||mmHg||Standard Error|Mean
102728|NCT00792636|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen|The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home BP assessment. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||millimeters of mercury (mmHg)||Standard Deviation|Mean
102729|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.||mmHg||Standard Deviation|Mean
102730|NCT00792610|Primary|Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)|The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.|7 months|||participants|||Number
102731|NCT00792298|Post-Hoc|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Period 1 (To Exclude Carryover Effect)|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. In order to evaluate the efficacy of suvorexant on LPS excluding the influence of a carryover effect from Period 1 to Period 2, an ad hoc analysis of LPS restricted to Period 1 data was also performed.|Night 1 (Period 1 only) and end of Week 4 (Period 1 only)|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
102732|NCT00792298|Secondary|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
102733|NCT00792298|Secondary|LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2|WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||minutes||Standard Error|Least Squares Mean
102734|NCT00792298|Primary|LS Mean Sleep Efficiency (SE) During Periods 1 and 2|SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.||percent of time in bed||Standard Error|Least Squares Mean
102823|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
102737|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS).|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|14 weeks (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||percentile||Standard Deviation|Mean
102738|NCT00792116|Secondary|State Anxiety Scores on the State Trait Anxiety Index for Children (STAIC).|The STAIC is a scale that distinguishes between a situationally based anxiety and a general intrinsic inclination towards experiencing feelings of anxiety|the beginning of a school semester and 14 weeks later (the end of a school semester)||||||
102739|NCT00792116|Secondary|Scores on the Math Anxiety Rating Scale for Adolescents (MARS-A)|he MARS-A (12) is a 98-item scale that lists various everyday situations in which adolescents may have to use mathematics.|the beginning of a school semester and 14 weeks later (the end of a school semester)||||||
102740|NCT00792116|Secondary|Math Scores on the Woodcock Johnson III Tests of Achievement (WJ-III)|The WJ-III (10) is a standardized test battery used to assess an individual’s academic strengths and weaknesses. For purposes of the current study, students were given the 4 math subtests of the WJ-III.|the beginning of a school semester and 14 weeks later (the end of a school semester)||||||
102741|NCT00792116|Primary|Math Grades||baseline (the beginning of a school semester )|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||average percentage correct||Standard Deviation|Mean
102742|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS)|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|the beginning of a school semester|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.||percentile||Standard Deviation|Mean
102743|NCT00792103|Secondary|Photophobia Free|Photophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participant|||Number
102744|NCT00792103|Secondary|Phonophobia Free|Phonophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participants|||Number
102745|NCT00792103|Secondary|Nausea Free|Nausea free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participants|||Number
102746|NCT00792103|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch activation|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea).||scores on a scale|Participants|Standard Deviation|Mean
102747|NCT00792103|Secondary|Pain Relief|Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.||participants|||Number
102748|NCT00791999|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
102749|NCT00791999|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
102750|NCT00791973|Secondary|Total Eye Symptom Scores After Antigen Challenge|Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe|After one week of treatment wtih veramyst or placebo|||units on a scale||Inter-Quartile Range|Median
102751|NCT00791973|Primary|Change in Tryptase Level From Baseline to Post-antigen Challenge|Tryptase levels (mcg/L) were measured from nasal lavages|After one week of treatment wtih veramyst or placebo|||mcg/L||Inter-Quartile Range|Median
102824|NCT00791518|Secondary|Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <50% and >=50% predicted||points on a scale||Standard Error|Mean
102752|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|10 weeks|The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.||scores on a scale||Standard Deviation|Mean
102753|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 year|The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.||scores on a scale||Standard Deviation|Mean
102754|NCT00791934|Secondary|Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg|Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).|10 weeks post-procedure|The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.||participants|||Number
102755|NCT00791934|Secondary|Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)|The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.|10 weeks post surgery|The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.||participants|||Number
102756|NCT00791934|Primary|Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.|The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.|10 weeks post-procedure|A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.||scores on a scale||Standard Deviation|Mean
102757|NCT00791921|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
102758|NCT00791921|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of participants|||Number
102759|NCT00791908|Primary|Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters|Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).|Baseline and 3 months|||Units on a scale||Full Range|Mean
102760|NCT00791817|Primary|Cmax|Maximum plasma concentration after a single dose|over 12 hours|||ng/mL||Standard Deviation|Geometric Mean
102761|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
102762|NCT00791778|Other Pre-specified|EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
102965|NCT00790803|Secondary|Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss|Patients best corrected visual acuity will be measured at each visit to monitor gain or loss of letters on the EDTRS chart.|32 weeks|||paticipants|||Number
102763|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
102764|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
102765|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
102766|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
102767|NCT00791778|Other Pre-specified|EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment||Scores on a scale||Standard Deviation|Mean
102768|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
102769|NCT00791778|Other Pre-specified|EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
102770|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
102771|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
102772|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
102773|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
102774|NCT00791778|Other Pre-specified|EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment||Scores on a scale||Standard Deviation|Mean
102809|NCT00791661|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|up to approximately 17 days|Participants who received study drug. The same participant may appear in more than one treatment arm.||participants|||Number
102775|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
102776|NCT00791778|Other Pre-specified|FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment||Scores on a scale||Standard Deviation|Mean
102777|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
102778|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5||Scores on a scale||Standard Deviation|Mean
102779|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
102780|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3||Scores on a scale||Standard Deviation|Mean
102781|NCT00791778|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 1 (4 weeks per Cycle)/baseline|Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment||Scores on a scale||Standard Deviation|Mean
102782|NCT00791778|Secondary|Overall Survival (OS)|The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).|From randomization of the first patient until 32.5 months later|FAS=all randomized participants||Days||95% Confidence Interval|Median
102783|NCT00791778|Secondary|Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level|Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment||Days||95% Confidence Interval|Median
102784|NCT00791778|Primary|Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment|Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Full analysis set (FAS)=all randomized participants||Days||95% Confidence Interval|Median
102785|NCT00791765|Secondary|Patient Satisfaction With Treatment at Week 12|This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from “very dissatisfied” to “very satisfied”) to indicate his or her level of satisfaction with the medication’s control of psoriasis.|12 Weeks|Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used.||participants|||Number
102786|NCT00791765|Secondary|Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12|Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation.||Percent change||Standard Error|Mean
102787|NCT00791765|Secondary|Percentage of Participants With PSSI 75% Response at Week 12|Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.|Baseline and Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation||Percentage of participants|||Number
102788|NCT00791765|Primary|Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12|The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 12|Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used.||Percent change||Standard Error|Mean
102789|NCT00791700|Secondary|Optimized Background Treatment (OBT) Susceptibility Scores (Net/Overall) by Outcome|Outcome (Response, PDVF or other/remainder) was summarized by the total ARV activity of the background regimen using simple and weighted totals (TOBT and p-wTOBTss, respectively) in the aggregate, categorized as 0, 1, ≥2 (TOBT) and 0 0.5, 1 1.5 and ≥2 (p-wOBTss) respectively, as well as by screening genotype. Six participants (Response: n=5; Other failure: n=1) failed to have successful PhenoSense GT analysis at screening, and so a net susceptibility score was not generated. One more participant was not included in the wOBTss analysis due to failed phenotype analysis. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores include: 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance.|48 weeks|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants|||Number
102790|NCT00791700|Secondary|Summary of the Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF: Total and by Cohort Prior to Week 48|Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Participants with more than one mutation are counted more than once.|48 weeks|"The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).~One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment."||Number of participants|||Number
102791|NCT00791700|Secondary|Shift Table of Viral Tropism Between Screening and Confirmed PDVF Prior to Week 48|Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. A shift table of the change in detected tropism from screening to the time of failure was produced in the aggregate and also broken down by age cohort.|Screening and Week 48|Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.||Number of participants|||Number
102792|NCT00791700|Secondary|Protocol Defined Virologic Failure|"The occurrence of any one of the following criteria would constitute Virologic failure:~A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days."|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Number of participants|||Number
102793|NCT00791700|Secondary|Change From Baseline in CD4+ Percent (%) at Weeks 24 and 48|Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||percentage of CD4+ cells||Standard Deviation|Mean
102794|NCT00791700|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48|Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||cells/mm^3||Standard Deviation|Mean
102795|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Log10 Copies/mL) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||Log10 Copies/mL||Standard Deviation|Mean
102796|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Original) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.||copies/mL||Standard Deviation|Mean
102797|NCT00791700|Secondary|Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48|Percentage of subjects with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). Last Observation Carried Forward (LOCF) was used to impute missing values.||percentage of participants||95% Confidence Interval|Number
102798|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48|TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants|||Number
103353|NCT00787566|Secondary|Time to Treatment Failure|Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first|24 hours||||||
102799|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants||95% Confidence Interval|Number
102800|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||Percentage of participants||95% Confidence Interval|Number
102801|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <48 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||percentage of participants|||Number
102802|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <400 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment.|The FAS will consist of all participants who receive at least one dose of study medication (same as APS4).||percentage of participants|||Number
102803|NCT00791700|Primary|Treatment Discontinuation Secondary to Serious Adverse Event (SAE) Related to Study Drug|The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).||participants|||Number
102804|NCT00791700|Primary|Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events (All Causality)|Safety was assessed by spontaneous reports, physical examination and laboratory test results in all participants who received at least 1 dose of study drug. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.|48 weeks|Safety analysis was performed on all participants who received at least 1 dose of study drug.||Number of events|||Number
102805|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - Tmax (Time at Maximum Concentration)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (Tmax) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.||hr||Full Range|Median
102806|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - AUCtau (Area Under the Curve at Steady State)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (AUCtau) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
102807|NCT00791700|Primary|Pharmacokinetic (PK) Parameters for Participants With Data in Stage 1 Enrolled in Stage 2 – Week 48|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of Analysis Population Set [APS] 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
102808|NCT00791661|Secondary|24-hour Weighted Mean Glucose (WMG) Concentration|Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.|Up to 36 hours|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||mg/dL||95% Confidence Interval|Least Squares Mean
102810|NCT00791661|Secondary|Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006|The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||hours||Standard Deviation|Mean
102811|NCT00791661|Secondary|Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||hours||Full Range|Median
102812|NCT00791661|Secondary|Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||nM||Standard Deviation|Mean
102813|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006|AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||nM*hr||Standard Deviation|Mean
102814|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006|AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.||nM*hr||Standard Deviation|Mean
102815|NCT00791661|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)|Participants who received study drug. The same participant may appear in more than one treatment arm.||participants|||Number
102816|NCT00791557|Primary|The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease|Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.|Week 26|Subjects who completed all required transfusions of infliximab were analyzed.||participants|||Number
102817|NCT00791518|Secondary|Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups|The number of participants with the indicated affected medical conditions were counted.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
102818|NCT00791518|Secondary|Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||puffs||Standard Error|Mean
102819|NCT00791518|Secondary|Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||puffs||Standard Error|Mean
102820|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
102821|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure||participants|||Number
103354|NCT00787566|Secondary|Time to First Rescue Medication||24 hours||||||
102825|NCT00791518|Secondary|Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <80% and >=80% percent predicted||points on a scale||Standard Error|Mean
102826|NCT00791518|Secondary|Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios|The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).|Day 1 of a 1-day study|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.||participants|||Number
102827|NCT00791518|Secondary|Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.||percentage of participants|||Number
102828|NCT00791518|Primary|Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.||percentage of participants|||Number
102829|NCT00791492|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included participants who received at least one dose of study medication.||participants|||Number
102830|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Holter Monitor Findings|Clinically significant Holter monitor findings included: atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (<30 beats), sustained ventricular tachycardia (>= 30 beats), sinus pause (RR >2.0 second, where RR=60/heart rate), ventricular premature contractions.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.||participants|||Number
102831|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.||participants|||Number
102832|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Echocardiography (ECHO) Findings|Clinically significant ECHO findings included: LV posterior wall thickness greater than or equal to (>=)13 mm, LV septal thickness >= 13 mm, right ventricular thickness >= 7 mm, ratio of peak mitral early diastolic and atrial contraction velocity (E/A ratio) >= 2, prime septal (E/E) >15, ejection fraction < 50 percent (%), E deceleration time <= 150 millisecond (ms), isovolumic relaxation time (IVRT) <= 70 ms, any valve thickening (> trace regurgitation in mitral, aortic, pulmonary, or tricuspid valves), abnormal respiratory variation of inferior vena cava, pericardial effusion.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.||participants|||Number
102833|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to Grade 3|AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.||participants|||Number
102851|NCT00791479|Secondary|Treatment Emergent Adverse Events|A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug.||participants|||Number
103355|NCT00787566|Secondary|Time to First Emetic Episode||24 hours||||||
102834|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|An Adverse Event (AE) was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug, up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.||participants|||Number
102835|NCT00791492|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
102836|NCT00791492|Secondary|Intraepidermal Nerve Fiber (IENF) Density|IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. It is used in diagnosing various neuropathic conditions.|Baseline|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||fibers/mm||Standard Deviation|Mean
102837|NCT00791492|Secondary|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 6, Month 3, 6 and 12|NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.||picogram/milliliter (pg/mL)||Full Range|Median
102838|NCT00791492|Secondary|Change From Baseline in Troponin I Concentration at Week 6, Month 3, 6 and 12|Troponin I was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular [LV] wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.||nanogram/milliliter (ng/mL)||Full Range|Median
102839|NCT00791492|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6 and 12|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
102840|NCT00791492|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6 and 12|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
102841|NCT00791492|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6 and 12|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
102842|NCT00791492|Secondary|Change From Baseline in Norfolk Quality of Life – Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptoms present, 0=symptoms absent. Item 8-35:scored on 5-point Likert scale: 0=no problem,4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment,for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
103356|NCT00787566|Secondary|Percentage of Patients Using Rescue Medications||24 hours||||||
103357|NCT00787566|Secondary|Percentage of Patients With Failure|Failure: > 5 emetic episodes|24 hrs||||||
102843|NCT00791492|Secondary|Change From Baseline in Neuropathy Impairment Score - Lower Limb (NIS-LL) Score at Month 6 and 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.||units on a scale||Standard Deviation|Mean
102844|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
102845|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
102846|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 12|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
102847|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 6|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
102848|NCT00791479|Secondary|Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 8 weeks, 12 weeks|Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams [mg]) with evaluable pharmacokinetic data.||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
102849|NCT00791479|Secondary|Antibody Production and Effects to LY2189265|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 4 weeks, 12 weeks, 16 weeks|Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.||participants|||Number
102850|NCT00791479|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have body weight change from baseline data available.||kilogram (kg)||Standard Error|Least Squares Mean
102884|NCT00791323|Primary|Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels|The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).|Day 3|Intent to Treat defined as all patients who started the study (randomized) with processed aqueous samples. Two patients in the Ketorolac 0.4% arm did not have aqueous humor samples processed.||Picograms per milliliter (pg/ml)||Standard Deviation|Mean
102852|NCT00791479|Secondary|Rate of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.||Events per participant per year||Standard Error|Least Squares Mean
102853|NCT00791479|Secondary|Number of Participants With Self-reported Hypoglycemic Events|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.||participants|||Number
102854|NCT00791479|Secondary|Change From Baseline in Blood Pressure (BP)|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood pressure change from baseline data available.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
102855|NCT00791479|Secondary|Change From Baseline in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have pulse rate change from baseline data available.||beats per minute (bpm)||Standard Error|Least Squares Mean
102856|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Heart Rate|Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have heart rate change from baseline data available.||beats per minute (bpm)||Standard Error|Least Squares Mean
102857|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.||millisecond (msec)||Standard Error|Least Squares Mean
102858|NCT00791479|Secondary|Change From Baseline in Insulin Sensitivity (HOMA2-%S)|Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.||percentage of HOMA2-%S||Standard Error|Least Squares Mean
102859|NCT00791479|Secondary|Change From Baseline in Beta-cell Function (HOMA2-%B)|Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.||percentage of HOMA2-%B||Standard Error|Least Squares Mean
102885|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
103161|NCT00789737|Secondary|% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units|to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage of participants|||Number
102860|NCT00791479|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
102861|NCT00791479|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.|12 weeks|Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.||percentage of participants|||Number
102862|NCT00791479|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
102863|NCT00791479|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.|Baseline, 4 weeks, 8 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
102864|NCT00791479|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
102865|NCT00790569|Primary|7-day Abstinence, CO-confirmed|Rates of CO-confirmed 7-day abstinence at 12-months|12 Months|||participants|||Number
102866|NCT00790569|Primary|7-day Abstinence, Self-reported|Rates of self-reported 7-day abstinence at 12-months|12 Months|||participants|||Number
102867|NCT00790569|Secondary|Reduction in Cigarettes Per Day|Change in mean cigarettes per day|6-Months|||cigarettes/day||Standard Deviation|Mean
102868|NCT00790569|Primary|Rates of Smoking Cessation Continuous|Rates of self-reported continuous abstinence 6 Months|6-Months|||participants|||Number
102869|NCT00790569|Primary|7-day Abstinence, CO-confirmed|Rates of CO-confirmed 7-day abstinence at 6-months|6-Months|||participants|||Number
102870|NCT00790569|Secondary|Reinforcing Effects of Smoking||12 months||||||
102871|NCT00790569|Secondary|Use of Illicit Drugs as Measured by Urine Toxicologies||12 months||||||
102872|NCT00790569|Secondary|Methadone Dose Changes||12 months||||||
102873|NCT00790569|Secondary|Retention in Methadone Maintenance||12 months||||||
102874|NCT00790569|Secondary|Withdrawal Symptoms||12 months||||||
102875|NCT00790569|Secondary|Smoking Urges||12 months||||||
102876|NCT00790569|Primary|7-day Abstinence, Self-report|Rates of self-reported 7-day abstinence at 6-months|6 Months|||participants|||Number
102877|NCT00790556|Other Pre-specified|Hepatic Glucose Production (HGP) at Baseline||Baseline|Subjects who discontinued were not used in the analysis.||mg/kg/min||Standard Deviation|Mean
102878|NCT00790556|Primary|Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14|Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.|Day 14 of each 14-day Treatment Period|Subjects who discontinued were not used in the analysis.||mg/kg/min||Standard Deviation|Mean
102879|NCT00790556|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)|"An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.~Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.~Drug-relatedness was determined by the investigator based on clinical judgement."|56 days|All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).||participants|||Number
102880|NCT00791388|Primary|t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14|t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14|over a Dosing Interval (τ = 12 Hours) on Day 14|||hours||Standard Deviation|Mean
102881|NCT00791388|Primary|Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14|the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14|12 Hours on Day 14|||hours||Standard Deviation|Mean
102882|NCT00791388|Primary|Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14|Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14|12 hours on Day 14|||ng/mL||Standard Deviation|Mean
102883|NCT00791388|Primary|AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14|the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours|14 days|PG 760564 blood plasma concentrations were not measured for the placebo arm||ng*h/mL||Standard Deviation|Mean
102886|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102887|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102888|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102889|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102890|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102891|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102892|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102893|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102894|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102895|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102896|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.||Percentage of participants|||Number
102897|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
102898|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
102899|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
102900|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.||Percentage of Participants|||Number
102901|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2||Percentage of Participants|||Number
102902|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.||Percentage of Participants|||Number
102903|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2||Percentage of Participants|||Number
102904|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2||Percentage of Participants|||Number
102905|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102906|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102907|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102908|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102909|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
102910|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
102911|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
102912|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.||Percentage of Participants|||Number
102913|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102914|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102915|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102916|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102917|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102918|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102919|NCT00791258|Secondary|Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102920|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102921|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102922|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102923|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102924|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102925|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102926|NCT00791258|Secondary|Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||mm Hg||Standard Error|Mean
102927|NCT00791258|Secondary|Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||mm Hg||Standard Error|Mean
102928|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||Percentage of participants|||Number
102929|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||Percentage of participants|||Number
102930|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||Percentage of participants|||Number
103358|NCT00787566|Secondary|Percentage of Patients With Minor Control of Emesis|Minor Control of emesis: 3-5 emetic episodes|24 hrs||||||
102931|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||Percentage of participants|||Number
102932|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.||Percentage of participants|||Number
102933|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM – 4PM.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.||Percentage of participants|||Number
102934|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102935|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102936|NCT00791258|Secondary|Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102937|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of Participants|||Number
102938|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||Percentage of participants|||Number
102939|NCT00791258|Secondary|Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||mm Hg||Standard Error|Mean
102940|NCT00791258|Secondary|Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.||mm Hg||Standard Error|Mean
102941|NCT00791258|Secondary|The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks||Baseline to 12 and 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.||Percentage of participants|||Number
102942|NCT00791258|Secondary|The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.||Percentage of participants|||Number
102943|NCT00791258|Primary|The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.||Percentage of participants|||Number
102944|NCT00791128|Secondary|Improvement in Type II Diabetes (Changes in HbA1c)||12 months|||HbA1c (%)||Standard Deviation|Mean
102945|NCT00791128|Primary|% of Excess Weight Loss||12 months|||% excess weight loss||Standard Deviation|Mean
102946|NCT00791102|Secondary|Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment||15 minutes prior to treatment and 15 minutes post antigen challenges|||L/min||Inter-Quartile Range|Median
102947|NCT00791102|Primary|Change in Itching Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||units on a scale||Inter-Quartile Range|Median
102961|NCT00790855|Primary|Maximum Tolerated Dose (MTD)|The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.|During course 1 (4 week cycle)|||mg/m^2|||Number
102948|NCT00791102|Primary|Change in Stuffy Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||units on a scale||Inter-Quartile Range|Median
102949|NCT00791102|Primary|Change in Runny Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||units on a scale||Inter-Quartile Range|Median
102950|NCT00791102|Secondary|Nasal Peak Inspiratory Flow Measurements|The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.|15 minutes after diluent challenge and 15 minutes after each antigen challenge|||L/min||Inter-Quartile Range|Median
102951|NCT00791102|Primary|Change in Sneezing Symptom|Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge|||sneezes||Inter-Quartile Range|Median
102952|NCT00790907|Secondary|Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population||participants|||Number
102953|NCT00790907|Secondary|Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population||participants|||Number
102954|NCT00790907|Secondary|Number of Participants With Major PCI-related Procedural Complications|Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.|During PCI procedure: immediately after randomization (approximately 10-75 minutes)|ITT Population||participants|||Number
102955|NCT00790907|Secondary|Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population||participants|||Number
102956|NCT00790907|Secondary|Number of Participants With Minor Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population||participants|||Number
102957|NCT00790907|Secondary|Number of Participants With Major Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population||participants|||Number
102958|NCT00790907|Secondary|Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR|ITT Population||participants|||Number
102959|NCT00790907|Primary|Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period|The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|Intent-to-Treat (ITT) Population: all randomized participants||participants|||Number
102960|NCT00790855|Secondary|Number of Participants With a Response|A complete response (CR) is defined as normalization of the bone marrow and peripheral blood counts with </= 5% marrow blasts in a normo-or hypercellular marrow, with a granulocyte count of >/= 10^9/L and a platelet count of >/=100 X 10^9/L. A partial response (PR) was defined as for CR, but with only >/=50% reduction of marrow blasts and to a range of 6%-25%. A marrow complete response was defined as a reduction of marrow blasts to </=5% but without recovery of peripheral counts.|1 - 24 week cycles (up to 8 weeks)|||participants|||Number
103359|NCT00787566|Secondary|Percentage of Patients With Major Control of Emesis|Major Control of emesis = 2 emetic episodes|24 hrs||||||
102966|NCT00790803|Primary|Improvement in VA ETDRS >/= 15 Letters|The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.|32 weeks|Five consecutive adult patients with non-infectious uveitis associated CME were chosen from the PI's regular medical clinic. Patients demonstrated, on fluorescein angiogram and/or optical tomography, bilateral or unilateral CME with non-infectious uveitis for greater than three months, but less than twelve.||participants|||Number
102967|NCT00790790|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 30% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||Time (days)|||Number
102968|NCT00790790|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (AEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.||participants|||Number
102969|NCT00790790|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance was the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
102970|NCT00790790|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, followup questions rated the degree to which the issue impaired his/her ability to do work or read.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||participants|||Number
102971|NCT00790790|Secondary|Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB ECG change >450 milliseconds (msec) was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||participants|||Number
102972|NCT00790790|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||beats per minute (bpm)||Standard Error|Least Squares Mean
102973|NCT00790790|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
102974|NCT00790790|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.||participants|||Number
102975|NCT00790790|Secondary|Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 147 participants randomized to study drug.||participants|||Number
102976|NCT00790790|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102977|NCT00790790|Secondary|Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102978|NCT00790790|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicated better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102979|NCT00790790|Secondary|Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks|The Total WOMAC index (pain, stiffness, physical function subscales) was completed by the participant and had 24 questions. Each question was answered using a 5-point Likert scale (0 to 4). The Total score had a range from 0 (none) to 96 (extreme). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102980|NCT00790790|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represented better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102981|NCT00790790|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I was a scale that measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102982|NCT00790790|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S was a self-reported scale measuring severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessed worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 Weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102983|NCT00790790|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I was a self-reported scale measuring degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessed interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102984|NCT00790790|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102985|NCT00790790|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of night pain and worst pain each day, evaluated as weekly means.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.||participants|||Number
102986|NCT00790790|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103162|NCT00789737|Secondary|Change in Fasting Plasma Glucose|to determine changes in Glycemic control after 24 weeks on therapy|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
102987|NCT00790790|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
102988|NCT00790790|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.||units on a scale||Standard Error|Least Squares Mean
102989|NCT00790751|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.||scores on a scale||Standard Error|Least Squares Mean
102990|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
102991|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.||percentage of sexual attempts||Standard Error|Least Squares Mean
102992|NCT00790738|Secondary|Clinical Global Impression Scores|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. At the time of rating patients are rated as: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|8 weeks|||units on a scale||Standard Deviation|Mean
102993|NCT00790738|Secondary|Clinician-Administered Rating Scale for Mania|The Clinician-Administered Rating Scale for Mania (CARS-M) contains 15 items rated from 0-5 or 0-6 on a Likert scale. It was developed to assess severity of manic symtoms. The scale ranges from 0 to 50, and the following thresholds are used: severe ≥26, moderate 16-25, mild 8-15 and normal ≤7.|8 weeks|||units on a scale||Standard Deviation|Mean
102994|NCT00790738|Primary|Hamilton Rating Scale for Depression Scores|The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms. The scale ranges from 0 to 50, and the following thresholds are used: very severe >23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.|8 weeks|||units on a scale||Standard Deviation|Mean
102995|NCT00790673|Secondary|Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects||16 weeks||||||
102996|NCT00790673|Primary|Pharmacokinetic Behavior of CF102 During Repeated Dosing||16 weeks||||||
102997|NCT00790673|Primary|Effect of Viral Load||16 weeks||||||
102998|NCT00790673|Primary|Adverse Event Profile of Repeated Dosing of CF102||16 weeks|||participants|||Number
102999|NCT00790647|Secondary|Number of Participants Surviving at 2 Years||2 years from transplant|||Participants|||Count of Participants
103000|NCT00790647|Secondary|Number of Participants Surviving at 1 Year||one year from transplant|||participants|||Number
103001|NCT00790647|Secondary|Number of Participants Surviving at 100 Days From Transplant||100 Days from transplant date|||participants|||Number
103002|NCT00790647|Primary|Number of Participants With Hematologic Response|"complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy <5% plasma cells with no clonal predominance of kappa or lambda isotype.~Partial response: any one of the following~For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells.~For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more.~For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume)."|one year|||participants|||Number
103003|NCT00790452|Primary|Frequency of VTE Events|Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.|VTE evaluation with study visits (4 weeks) for up to 2 years|Analysis was to be per protocol, study terminated early with no analysis. Only enrolled participant to the study was prematurely taken off the study due to a drug supply issue.||participants|||Number
103030|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Intent to Treat Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value.||Percentage of HbA1c||Standard Deviation|Mean
103004|NCT00790400|Secondary|Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)|Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician’s global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by >=25% or more.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.||months||95% Confidence Interval|Median
103005|NCT00790400|Secondary|Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.||months||95% Confidence Interval|Median
103006|NCT00790400|Secondary|Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|"Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume > 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.||months||95% Confidence Interval|Median
103007|NCT00790400|Secondary|Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose|C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be excluded from all analyses.|2 hours post-dose administration at Weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.||ng/mL||Standard Deviation|Mean
103008|NCT00790400|Secondary|Everolimus Trough Concentrations (Cmin)|Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.|Prior to dosing at weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.||ng/mL||Standard Deviation|Mean
103009|NCT00790400|Secondary|Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker|Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.|4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||pg/mL||Standard Deviation|Mean
103010|NCT00790400|Secondary|Percentage of Participants With Renal Impairment|Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of <30ml/min/1.73m2.|Day 1 up to 28 days after end of treatment|Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.||Percentage of Participants|||Number
103011|NCT00790400|Secondary|Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)|Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician’s Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.||Percentage of participants||95% Confidence Interval|Number
103112|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
103012|NCT00790400|Secondary|Time to Angiomyolipoma Progression as Per Central Radiology Review|"Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.||months||95% Confidence Interval|Median
103013|NCT00790400|Primary|Angiomyolipoma Response Rate as Per Central Radiology Review|"Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.||Percentage of Participants||95% Confidence Interval|Number
103014|NCT00790296|Primary|Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion|1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.|Baseline and 7 hours post study medication infusion|||Scores on a scale||Standard Deviation|Mean
103015|NCT00790270|Secondary|Resumption of Work or School|number of patients resuming regular activity the day following enrollment.|next day|||participants|||Number
103016|NCT00790270|Primary|Use of Rescue Medications|the number of patients taking additional rescue medications beyond the study meds|24 hours|number of patients using additionl anlagesics on the day following enrollment||participants|||Number
103017|NCT00790270|Secondary|Time to Resumption of Work||1 week||||||
103018|NCT00790270|Primary|Pain||Daily for 1 week||||||
103019|NCT00790218|Primary|Maximum Tolarated Dose|The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.|first 28 days (Cycle 1)||||||
103020|NCT00790218|Secondary|Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102||Baseline||||||
103021|NCT00790218|Secondary|Therapeutic Effect of CF102 in Hepatocellular Carcinoma||Every 2 months||||||
103022|NCT00790218|Primary|Repeat-dose Pharmacokinetic Behavior of CF102||1 month||||||
103023|NCT00790218|Primary|Dose Limiting Toxicity|Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1|From start of treatment until Day 28 of Cycle 1|||participants|||Number
103024|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
103025|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
103026|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
103027|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
103028|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value for the outcome measure.||g/mol Creatinine||Standard Deviation|Mean
103029|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.||g/mol Creatinine||Standard Deviation|Mean
103031|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Per Protocol Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.||Percentage of HbA1c||Standard Deviation|Mean
103032|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Intent to Treat Population)|Change in renal function based on eGFR using the MDRD method.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value.||mL/min/1.73 m^2||Standard Deviation|Mean
103033|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Per Protocol Population)|Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.||mL/min/1.73 m^2||Standard Deviation|Mean
103034|NCT00790205|Secondary|Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
103035|NCT00790205|Secondary|Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
103036|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Intent to Treat Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
103037|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Per Protocol Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
103038|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
103039|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
103040|NCT00790205|Primary|Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.||Percentage of participants|||Number
103041|NCT00790205|Primary|Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.||Percentage of participants|||Number
103042|NCT00790192|Secondary|Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 (‘normal’, not ill) to 7 (extremely ill).|6-Weeks|||scores on a scale||95% Confidence Interval|Least Squares Mean
103043|NCT00790192|Primary|Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Week 6|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||scores on a scale||95% Confidence Interval|Least Squares Mean
103163|NCT00789737|Primary|Percent Change in Hemoglobin A1c|change in HbA1c from baseline to Week 24|24 week|Intent to Treat, Last Observation Carried Forward (LOCF) Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage change of hemoglobin A1c||Standard Error|Mean
103044|NCT00790062|Primary|Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors|The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.|baseline to discharge (2-3 days)|||participants|||Number
103045|NCT00790062|Secondary|Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus|number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)|Initial hospital discharge (2-3 days or more)|||Participants|||Number
103046|NCT00790062|Secondary|Number of Subjects With Hospital Stays Greater Than 4 Days|Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge|Initial hospital discharge (2 days or more)|||Participants|||Number
103047|NCT00790062|Secondary|Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)|the number of individuals with a clinically estimated postpartum blood loss of 500cc or more|Initial hospital discharge (2-3 days)|||Participants|||Number
103048|NCT00790062|Secondary|Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome|the number of individuals with each of the component treatments or individual outcomes in the primary composite.|prior to discharge|||Participants|||Number
103049|NCT00790062|Secondary|Change in Pre- to Post-delivery Hematocrit (%)|change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)|During delivery hospitalization: Admission hematocrit - post-delivery hematocrit|||hematocrit difference (%)||Inter-Quartile Range|Median
103050|NCT00790062|Primary|Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage|In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.|Initial hospital discharge (2-3 days)|||participants|||Number
103051|NCT00790062|Primary|Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment|the number of subjects with any treatment of uterineatony or hemorrhage.|baseline to discharge (2 - 3 days)|||Participants|||Number
103052|NCT00790023|Secondary|Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day.|Week 0-2|Intent to Treat Population||days||Standard Error|Least Squares Mean
103053|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0|"Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval."|Baseline and up to 48 hours|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103054|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)|"Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline.~TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval."|Baseline and up to 36 hours|Intent to Treat Population. Some participants excluded for missing data.||Units on a scale||Standard Error|Least Squares Mean
103055|NCT00790023|Secondary|Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0|The RQLQ(S) in impaired subjects (baseline RQLQ[S] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In participants with a Baseline overall score >= 3.0||units on a scale||Standard Error|Least Squares Mean
103056|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103057|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103360|NCT00787566|Secondary|Percentage of Patients With Total Response|Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications|24 hours||||||
103058|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103059|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103060|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103061|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103062|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103063|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103064|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103065|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103066|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103113|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
103361|NCT00787566|Secondary|Percentage of Patients With Complete Response|Complete Response is defined as no emetic episodes and no use of rescue medications|24 hours||||||
103067|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103068|NCT00790023|Secondary|Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103069|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103070|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103071|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103072|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0||Units on a scale||Standard Error|Least Squares Mean
103073|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103074|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103075|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103114|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), All Patients|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
103076|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|||Units on a scale||Standard Error|Least Squares Mean
103077|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population. In participants with a baseline rTOSS >= 5.0||units on a scale||Standard Error|Least Squares Mean
103078|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population||units on a scale||Standard Error|Least Squares Mean
103079|NCT00790023|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population.||units on a scale||Standard Error|Least Squares Mean
103080|NCT00789997|Secondary|Number of Participants With Treatment Failure by 90 Days Assignment|In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group.|Day 0 to Day 90|||participants|||Number
103081|NCT00789997|Primary|Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.~Not all participants had Day 14 FEV1 measures collected"|Day 0 to Day 14|||percentage of change in FEV1||Standard Error|Mean
103082|NCT00789958|Secondary|2-year Overall Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
103083|NCT00789958|Secondary|2-year Stratum-specific Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
103084|NCT00789958|Secondary|2-year Disease-free Survival in All Patients|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
103085|NCT00789958|Secondary|2-year Stratum-specific Disease-free Survival|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
103086|NCT00789958|Secondary|2-year Overall Survival for All Patients|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
103087|NCT00789958|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
103088|NCT00789958|Primary|Stratum-specific (R0 and R1) 2-year Overall Survival|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.||percentage of participants||95% Confidence Interval|Number
103115|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Deviation|Mean
103164|NCT00789724|Secondary|Difference Between the 2 Arms in the Number of Adverse Effects Including a) All Events; b) All Events Requiring Unblinding of the Treatment; c) All Events Requiring Early Termination of the Intervention||10-14 weeks||||||
103089|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103090|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103091|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103092|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103093|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103094|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103095|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103116|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Deviation|Mean
103117|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Deviation|Mean
103165|NCT00789724|Secondary|Difference Between the 2 Arms in the Incidence of Significant Cardiac Arrhythmias in the Acute Phase||48 hours||||||
103096|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103097|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21|||Cycle Number||Standard Deviation|Mean
103098|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 week of treatments|||Participants|||Number
103099|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 weeks of treatment|||Participants|||Number
103100|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).|6 weeks of treatment|||Participants|||Number
103101|NCT00789854|Secondary|Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)|Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
103102|NCT00789854|Secondary|Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility|Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
103103|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component|Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
103104|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component|Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
103105|NCT00789854|Secondary|Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)|Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
103106|NCT00789854|Secondary|Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4|Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)|6 weeks of treatment|||MADRS item 4 score||Standard Error|Least Squares Mean
103107|NCT00789854|Secondary|Change in Anxiety Measured by STAI, Trait Anxiety Inventory|Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
103108|NCT00789854|Secondary|Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment|||Scores on a scale||Standard Error|Least Squares Mean
103109|NCT00789854|Secondary|Change in Anxiety Measured by Visual Analog Scale (VAS)|Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
103110|NCT00789854|Secondary|Change in Pain, Measured by Visual Analog Scale (VAS)|Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
103111|NCT00789854|Secondary|Change in Beck Depression Inventory (BDI)|Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
103118|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment|||Participants|||Number
103119|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment|||Participants|||Number
103120|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 week of treatments|||Participants|||Number
103121|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
103122|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
103123|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure|Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
103124|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure|Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
103125|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients|Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment|||Participants|||Number
103126|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks of treatment|||scores on a scale||Standard Error|Least Squares Mean
103127|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks treatment|Analysis was 'per protocol'. Exclusion reason from analysis: Violation of exclusion/inclusion criteria; Non-compliance regarding prohibited concomitant medication, Total unavailability of MADRS score after randomization, Patient not treated with any dose of study drug after randomization, Non-compliance regarding titration to 300 mg quetiapine/d.||scores on a scale||Standard Error|Least Squares Mean
103128|NCT00789828|Secondary|Percentage of Participants With Renal Impairment During Core Period|Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788*(serum creatinine (micromol/L)^-1.154)*(age^-0.203 )*(0.742, if female)*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR < 30 mL/min/1.73 m^2 and participants with National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.|Day 1 up to 28 days after end of treatment (Core period)|"The analysis was performed in the SAF population. Here, Number of participants analysed signifies the participants assessed for renal function during the study for each arm, respectively."||Percentage of participants|||Number
103129|NCT00789828|Secondary|Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose|The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as <5 ng/mL, 5-10 ng/mL, and >10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||ng/mL||Standard Deviation|Mean
103130|NCT00789828|Secondary|Everolimus Blood Concentration (C2h) at 2 Hours Post Dose|The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as < 20 ng/mL, 20-50 ng/mL, and > 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||ng/mL||Standard Deviation|Mean
103166|NCT00789724|Secondary|Difference Between the 2 Arms in Change in Serum BNP Levels, C-reactive Protein, and Hemoglobin A1c% From Baseline to Follow up||10-14 weeks||||||
103131|NCT00789828|Secondary|Duration of Skin Lesion Response in Everolimus Treated Participants|Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by > 25% or more from baseline.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population. Here, “Number of participants analysed” signifies everolimus treated responders with best overall skin lesion response during the core and extension period, respectively.||months||95% Confidence Interval|Median
103132|NCT00789828|Secondary|Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score|Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician’s Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but < 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - < 50% and 6 = progressive disease, indicated worse than at baseline evaluation by > 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response.|End of core period (Week 48), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for skin lesion response during the study for each arm, respectively."||Percentage of participants||95% Confidence Interval|Number
103133|NCT00789828|Secondary|Time to SEGA Worsening|Time to SEGA worsening was defined as the time from the start of everolimus to date of the first SEGA worsening. SEGA worsening was defined as either; increase from nadir of ≥ 25% in SEGA volume or unequivocal worsening of non-target SEGA lesions, or appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, or new or worsening hydrocephalus. The median value was not reached in either treatment arm of core period as SEGA worsening was observed in less participants (everolimus - 7 and placebo - 8).|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for time to SEGA worsening during the study for each arm, respectively."||months||95% Confidence Interval|Median
103134|NCT00789828|Secondary|Duration of SEGA Response|Duration of SEGA response was defined as time from the date of the first documented SEGA response until the date of the first documented SEGA progression. Duration of SEGA response was evaluated only for participants who achieved a SEGA response. The time to SEGA progression was censored if SEGA progression was not observed before the first to occur out of (i) analysis cut-off date (ii) the date when systemic anti-SEGA medication is started, (iii) the date of a SEGA-related surgery or (iv) the date of death. Since, no case of SEGA progression was observed in core study which resulted in censored duration of SEGA response. Only 5 SEGA responders experienced a SEGA progression in extension period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for SEGA progression during the study for each arm, respectively."||months||95% Confidence Interval|Median
103135|NCT00789828|Secondary|Time to SEGA Response|Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population.||months||95% Confidence Interval|Median
103136|NCT00789828|Secondary|Time to SEGA Progression|Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here Number of participants analysed signifies the participants assessed for time to SEGA progression during the study for each arm, respectively."||months||95% Confidence Interval|Median
103137|NCT00789828|Secondary|Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period|Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was < 18 hours.|Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)|The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.||Seizure frequency||Standard Deviation|Mean
103157|NCT00789737|Secondary|Changes in Low Density Lipoprotein Cholesterol [LDL-C]|To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
103158|NCT00789737|Secondary|Changes in Total Cholesterol [TC]|To assess the effects of Welchol on changes in total cholesterol [TC]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
103159|NCT00789737|Secondary|% Subjects With a Decrease in FPG >=30 mg/dL|% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage of participants|||Number
103138|NCT00789828|Primary|Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response|Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|End of core period (Week 48), and end of extension period (up to 4 years)|The primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.||Percentage of participants||95% Confidence Interval|Number
103139|NCT00789815|Secondary|Patients Willing Return if Repeated Bronchoscopy is Indicated.|"Patients were asked their willingness to return for another FB if needed by means of a five-point scale (definitely not, probably not, unsure, probably would, and definitely would return). Both probably would, and definitely would return were defined as patients agreed to return."|After patients recovered orientation and before they leaved the scope room.|Patients who answered the question in the questionnaire after bronchoscopy||participants|||Number
103140|NCT00789815|Secondary|The Recovery Time to Ambulation|The recovery time to ambulation defined as the time between finishing flexible bronchoscopy to the moment when patients could walk without assistance.|After the bronchoscopy|||Minutes||Standard Deviation|Mean
103141|NCT00789815|Primary|The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale|The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).|After patients recovered orientation and before they leaved the scope room.|Patients received intervention completely||units on a scale||Full Range|Median
103142|NCT00789815|Secondary|The Recovery Time to Orientation|The time to orientation defined as the time between finishing flexible bronchoscopy to the moment when patients could open their eyes spontaneously, could recall their date of birth, and perform a finger-nose test correctly|After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation|||minutes||Standard Deviation|Mean
103143|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by Cough|“Procedure interference by cough” was when the bronchoscopist had to stop the procedure temporarily and additional xylocaine spray and/or alfentanil had to be given to stop the cough.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|||participants|||Number
103144|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy|“Procedure interference by patients’ movement” was when the bronchoscopist had to stop the procedure temporarily and our assistant had to hold down the irritant patient|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|||participants|||Number
103145|NCT00789815|Primary|The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy|The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|patients completed the whole intervention||participants|||Number
103146|NCT00789815|Primary|The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy|The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|Patients completed the whole intervention.||participants|||Number
103147|NCT00789802|Secondary|To Compare Continuation Rates of the LNG-IUC at the End of the 16 Week and 12 Month Periods Between the 3 Study Groups||12 months||||||
103148|NCT00789802|Secondary|To Compare the Level of Patient Satisfaction With the LNG-IUC at the End of the 16 Week and 12 Months Periods Between the 3 Study Groups.||16 week||||||
103149|NCT00789802|Secondary|To Describe and Compare the Bleeding Patterns Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.||16 weeks||||||
103150|NCT00789802|Primary|Number of Bleeding and Spotting Days|The median number of bleeding and spotting days was 27.5 (range 5-83) in the naproxen group, 44 (2-82) in the estradiol group, and 32 (9-84) in the placebo group.|12 weeks|||DAYS||Full Range|Median
103151|NCT00789737|Secondary|Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test|To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
103152|NCT00789737|Secondary|Changes in Apolipoprotein B (apoB)|To assess the effects of Welchol on changes in apolipoprotein B (apoB)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
103153|NCT00789737|Secondary|Changes in Apolipoprotein A-I (apoA-I)|To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
103154|NCT00789737|Secondary|Changes in Triglycerides [TG]|To assess the effects of Welchol on changes in triglycerides [TG]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
103155|NCT00789737|Secondary|Changes in Non-HDL-C|To assess the effects of Welchol on changes in non-HDL-C|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||mg/dL||Standard Error|Least Squares Mean
103156|NCT00789737|Secondary|Changes in High Density Lipoprotein Cholesterol [HDL-C]|To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||md/dL||Standard Error|Least Squares Mean
103160|NCT00789737|Secondary|% Subjects Achieving an HbA1C Goal of <7.0|% Subjects achieving an HbA1C goal of <7.0 at 24 weeks|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.||percentage of participants|||Number
103173|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores|The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements||units on a scale||95% Confidence Interval|Least Squares Mean
103174|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)|The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements||units on a scale||95% Confidence Interval|Least Squares Mean
103175|NCT00789698|Secondary|Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.|The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.|Baseline and 6 Months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements||units on a scale||95% Confidence Interval|Least Squares Mean
103176|NCT00789698|Primary|Relapse of Psychotic Symptoms|"Time to relapse will be defined as the earliest occurrence of any of the following:~Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3~rehospitalization for worsening of psychosis~emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate."|12 Months|The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.||participants|||Number
103177|NCT00789685|Secondary|All Cause Mortality Rate at 6 Months|A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment|6 months following commencement of therapy|Number of patients whose survival status at 6 months was known||percentage of patients who died|||Number
103178|NCT00789685|Primary|All Cause Mortality at Day 28|The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment|28 days following commencement of therapy|Patients included in Safety population||percentage of patients who died|||Number
103179|NCT00789685|Primary|Clinically Significant Treatment Emergent Events|Treatment-emergent adverse events (TEAEs) in safety population|From first dose up until Day 28|Patients included in Safety population||Number of patients|||Number
103180|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa|||letters||Standard Deviation|Mean
103181|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa|||participants|||Number
103182|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks|||letters||Standard Deviation|Mean
103183|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks|||participants|||Number
103184|NCT00789672|Primary|Tolerability of Study Medication-Adverse Event Reporting|Number of adverse events reported throughout entire study.|24 weeks|||events|||Number
103185|NCT00789672|Primary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks|||letters||Standard Deviation|Mean
103186|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|10 weeks after stopping levodopa|||letters||Standard Deviation|Mean
103187|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|10 weeks after stopping levodopa|||participants|||Number
103188|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|4 weeks after enrollment|||letters||Standard Deviation|Mean
103189|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|4 weeks after enrollment|||participants|||Number
103190|NCT00789672|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks|||participants|||Number
103191|NCT00789672|Primary|Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|9 weeks after starting levodopa|||letters||Standard Deviation|Mean
103192|NCT00789672|Primary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|9 weeks after starting levodopa|||participants|||Number
103193|NCT00789555|Primary|Self-Rated Relief Assessment at Day 30|"Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."|Day 30|Analysis population included all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Units on a scale||Standard Deviation|Mean
103194|NCT00789555|Secondary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
103195|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
103196|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
103197|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
103198|NCT00789555|Primary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|Analysis population included all subjects who received study drug and attended at least one on-therapy study visit (ITT), minus any missing data.||Percentage of subjects|||Number
103199|NCT00789529|Secondary|Subject Questionnaire Response|"Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.~0=Very poor 50 = Excellent"|2 weeks|||units on a scale||Standard Deviation|Mean
103200|NCT00789529|Primary|Objective, In-vivo Soft Contact Lens Wettability Index|The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack–Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.|2 weeks|Per protocol. All participants that completed both arms were analysed.||wettability index||Standard Deviation|Mean
103201|NCT00789477|Secondary|Number of Focal Laser Treatments||Week 1 to week 48|For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.||Treatments||Standard Deviation|Mean
103202|NCT00789477|Secondary|Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF|Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52|||microns||Standard Deviation|Mean
103203|NCT00789477|Secondary|Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF|Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52|FAS||participants|||Number
103204|NCT00789477|Secondary|Change in BCVA From Baseline to Week 52 - LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 52|FAS||letters correctly read||Standard Deviation|Mean
103205|NCT00789477|Primary|Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|"Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.~Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF)."|At week 24|The FAS was used for the primary efficacy analysis. It included patients as randomized.||letters correctly read||Standard Deviation|Mean
103206|NCT00789438|Primary|Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints|Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.|Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay|||SPI and delta SPI (to baseline)||Standard Error|Median
103207|NCT00789373|Secondary|Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.|Date of randomization to date of measured PD (up to 19.3 months)|All randomized participants||percentage of participants||95% Confidence Interval|Number
103208|NCT00789373|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off|Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.|Baseline to date of measured progressive disease (up to 19.3 months)|All randomized participants||percentage of participants|||Number
103209|NCT00789373|Secondary|Percentage of Participants With Serious Adverse Events During Maintenance Phase|A summary of serious adverse events is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with all serious adverse events included.||percentage of participants|||Number
103210|NCT00789373|Secondary|Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase|A summary of non-serious AEs is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.||percentage of participants|||Number
103211|NCT00789373|Secondary|Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)||Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|All randomized participants||percentage of participants|||Number
103212|NCT00789373|Secondary|Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)|Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline.||units on a scale||Standard Deviation|Mean
103213|NCT00789373|Secondary|Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score|The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline.||units on a scale||Standard Deviation|Mean
103214|NCT00789373|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.|Date of randomization to the date of death from any cause up to 39.5 months|All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.||months||95% Confidence Interval|Median
103215|NCT00789373|Secondary|Independently-assessed Objective Progression-free Survival (PFS)|To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)|Randomized participants with reviewable scan--(316/359 [88%] Maintenance arm and 156/180 [87%] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).||months||95% Confidence Interval|Median
103216|NCT00789373|Primary|Investigator-assessed Objective Progression-free Survival (PFS)|Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)|All randomized participants||months||95% Confidence Interval|Median
103217|NCT00787852|Secondary|Complete and Partial Response by CT Scan or MRI||within 30 days of last treatment||||||
103218|NCT00787852|Primary|Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0|6 patients came off study for toxicity|within 28 days after the last radiation treatment|||participants|||Number
103219|NCT00787839|Secondary|Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes|Cost was expressed as cost (dollars) to identify a single case, with cases defined as (i) diabetes or (ii) high-risk dysglycemia. Cost projections for screening were conducted from both Medicare and VA perspectives. All screening projections assumed follow-up testing with an OGTT if the screening test exceeded a 70% specificity cut-off.|3 years|||Dollars|||Number
103220|NCT00787839|Primary|Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast)|"Area under ROC curve (AROC) for prediction of diabetes (based on OGTT) and high-risk dysglycemia (based on OGTT, IGT with 2 hour OGTT glucose 140-199 mg/dl, and/or IFG with fasting glucose 110-125 mg/dl).~ROC curves are plots of (1-sensitivity) vs. (1-specificity) for all possible screening cutoffs, so a higher AROC indicates higher predictive accuracy. A perfect test would have an AROC of 1.00, while a test equivalent to tossing a coin (random) would have an AROC of 0.50; if confidence limits include 0.50, predictive accuracy is no better than chance.~It is important to appreciate that while AROC analysis can show the relative accuracy of different screening tests, and aid the selection of which test to use in clinical practice, such an analysis does not define what the optimal screening test cutoff is. Selection of the optimal cutoff generally requires consideration of other factors, such as costs and/or the clinical importance of having higher or lower sensitivity."|3 years|||area under ROC curve||95% Confidence Interval|Number
103221|NCT00787800|Secondary|Atrial Fibrillation (AF) Burden|AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.|Implantation through 1 year|Intent to treat analysis population.||Percentage of atrial arrhythmias per min||Standard Deviation|Mean
103222|NCT00787800|Secondary|Number of Subjects With Newly Detected Atrial Tachyarrhythmias||Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.||Participants|||Number
103223|NCT00787800|Secondary|Total Cost of ICD Implantation Procedure||Baseline|Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.||US Dollars||Standard Deviation|Mean
103224|NCT00787800|Secondary|Number of Appropriate Shocks by ICD|Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.|Baseline to 12 Months|Intent to Treat population analyzed.||Shocks|||Number
103225|NCT00787800|Secondary|Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes|Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.|Baseline to 12 Months|Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).||Episodes|||Number
103226|NCT00787800|Primary|Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)|An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).|Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.||Participants|||Number
103227|NCT00787761|Secondary|Overall Survival (OS) at 24 Months|Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease.|24 months|23 patients were able to be analyzed for OS at 24 months||participants|||Number
103228|NCT00787761|Secondary|Disease-free Survival (DFS) at 24 Months|Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted.|24 months|23 patients were able to be analyzed for DFS at 24 months||participants|||Number
103229|NCT00787761|Secondary|Non-relapse Mortality (NRM) at Day 180 Post-transplantation|non-relapse mortality refers to the death of a patient for causes other than relapsed disease.|Day 180|23 patients were able to be analyzed for NRM at 180 days||participants|||Number
103230|NCT00787761|Secondary|Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)|Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|2 years|23 patients were able to be analyzed for severe gvhd||participants|||Number
103231|NCT00787761|Secondary|Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease|number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|Day 100|23 patients were able to be analyzed for severe gvhd||participants|||Number
103232|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|180 days|20 of the patients treated on study had chimerism drawn on day 180.||participants|||Number
103233|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|20 of the patients treated on this study had Day 90 chimerism drawn.||participants|||Number
103234|NCT00787761|Primary|Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|only 15 of the patients treated on study had Day 30 chimerism results.||participants|||Number
103235|NCT00789321|Secondary|Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2|Least Squares Mean Difference from Baseline|Baseline and 2 weeks|All patients treated with water displacement measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2) – two patients in the amlodipine group were excluded due to technical/procedural errors.||Grams||Standard Deviation|Least Squares Mean
103236|NCT00789321|Primary|Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2|Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.|Baseline and 2 weeks|All patients treated with segmental bioimpedance measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2).||Ohms||Standard Deviation|Least Squares Mean
103237|NCT00789256|Secondary|Determine Correlation Between in Vitro and in Vivo Activity of the Combination of Bortezomib and Melphalan.||7 Years||||||
103238|NCT00789256|Secondary|Determine Safety Profile of the Combination of Bortezomib and Melphalan.||7 Years||||||
103239|NCT00789256|Primary|Determine Response Rate of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS.||7 Years|||participants|||Number
103240|NCT00789191|Secondary|Self-measured 9-point Plasma Glucose Profile||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||mmol/L||Standard Error|Mean
103241|NCT00789191|Secondary|Hypoglycemic Episodes: Night Time|Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
103242|NCT00789191|Secondary|Hypoglycemic Episodes: Day Time|Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
103243|NCT00789191|Secondary|Hypoglycemic Episodes|Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
103244|NCT00789191|Secondary|FPG (Fasting Plasma Glucose)||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||mmol/L||Standard Error|Mean
103245|NCT00789191|Secondary|Change in Body Weight||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||kg||Standard Error|Mean
103246|NCT00789191|Secondary|Change in BMI (Body Mass Index)||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||kg/m^2||Standard Error|Mean
103247|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
103248|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
103249|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
103250|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Subjects|||Number
103251|NCT00789191|Primary|HbA1c (Glycosylated Haemoglobin A1c)||Week 26|Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.||Percent (%) glycosylated haemoglobin||Standard Error|Mean
103252|NCT00789113|Primary|Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG|To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.|1 week|||µg*h/mL||95% Confidence Interval|Geometric Mean
103253|NCT00789074|Secondary|Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence|"Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).~* The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual)."|Week 4 - 8|Participants who were abstinent at 1 week and provided data on withdrawal symptoms||Scores on a scale||Standard Deviation|Mean
103254|NCT00789074|Secondary|Change in Pre-quit Cigarette Consumption|Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.|Baseline - week 4|All participants that provided data at each session||Cigarettes consumed per day||Standard Deviation|Mean
103255|NCT00789074|Secondary|Change in Pre-quit Ratings of Cigarette Satisfaction|"Satisfaction measured on a scale of 1-5; Have you found your cigarettes more or less enjoyable than usual in the last week? 1= much more and 5 = much less"|Baseline - week 4|Participants who provided ratings of cigarette satisfaction at each visit||units on a scale||Standard Deviation|Mean
103256|NCT00789074|Secondary|Change in Pre-quit Cotinine Levels|Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.|Weeks 1-4 (the first 4-weeks after first medication dose)|All participants that provided data at all time points||ng/ml||Standard Deviation|Mean
103257|NCT00789074|Secondary|Change in Pre-quit End-expired Carbon Monoxide Reading (CO)|"Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.~CO was measured at each contact to monitor changes in smoke intake and differences between the study arms."|Baseline - week 8|Participants that provided data at all time points||ppm||Standard Deviation|Mean
103258|NCT00789074|Primary|Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale|The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.|24 hours and 7 days after quit date (week 4)|Were abstinent and provided data at 24 hours post quit date||units on a scale||Standard Deviation|Mean
103259|NCT00789035|Secondary|Trough Concentrations of Empagliflozin in Plasma|Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
103260|NCT00789035|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||kg||Standard Error|Mean
103261|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU / mmol||Standard Error|Mean
103262|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU/L x mmol/L||Standard Error|Mean
103263|NCT00789035|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU/L||Standard Error|Mean
103264|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).|12 weeks|FAS (CLOCF)||percentage of participants|||Number
103265|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).|12 weeks|FAS (CLOCF)||percentage of participants|||Number
103266|NCT00789035|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS, classical last observation carried forward (CLOCF) was used as the imputation method.||percentage of HbA1c||Standard Error|Mean
103267|NCT00789035|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|FAS (LOCF)||mg/dL||Standard Error|Mean
103268|NCT00789035|Primary|Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment|"Change of HbA1c from baseline after 12 weeks of treatment.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF).||percentage of HbA1c||Standard Error|Mean
103269|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Ganitumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
103270|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Ganitumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
103271|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Rilotumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
103272|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Rilotumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
103273|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Panitumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
103274|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Panitumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).||μg/mL||Standard Deviation|Mean
103275|NCT00788957|Secondary|Part 1: Area Under the Drug Concentration-time Curve During a Dosing Interval (AUCtau) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.||day*μg/ml||Standard Deviation|Mean
103276|NCT00788957|Secondary|Part 1: Maximum Observed Drug Concentration (Cmax) and Minimum Drug Concentration (Cmin) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.||μg/ml||Standard Deviation|Mean
103277|NCT00788957|Secondary|Number of Participants With Antibody Formation to Panitumumab, Rilotumumab and Ganitumab|Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set participants with at least one post-baseline immunoassay result.||participants|||Number
103278|NCT00788957|Secondary|Number of Participants With Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).||participants|||Number
103279|NCT00788957|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?”|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).||participants|||Number
103280|NCT00788957|Secondary|Overall Survival|The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set||months||95% Confidence Interval|Median
103281|NCT00788957|Secondary|On-treatment Progression-free Survival|An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.|From the date of first dose until 28 days after the last dose until the data cut-off date of 23 July 2010. Median time on treatment was 3.7, 4.9 and 5.1 months in each treatment arm respectively.|Efficacy analysis set||months||95% Confidence Interval|Median
103282|NCT00788957|Secondary|Progression-free Survival|The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set||months||95% Confidence Interval|Median
103362|NCT00787566|Primary|Percentage of Patients With Complete Control|Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.|24 hours|ITT population||Percentage|||Number
103283|NCT00788957|Secondary|Part 2: Percentage of Participants With Disease Control|The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set||percentage of participants||95% Confidence Interval|Number
103284|NCT00788957|Secondary|Part 2: Time to Response|The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.||months||95% Confidence Interval|Median
103285|NCT00788957|Secondary|Part 2: Duration of Response|The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.||months||95% Confidence Interval|Median
103286|NCT00788957|Primary|Part 2: Percentage of Participants With an Objective Response|An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.||percentage of participants|||Number
103287|NCT00788957|Primary|Part 1: Number of Participants With Dose-limiting Toxicities (DLT)|A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator|7 weeks|The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.||participants|||Number
103288|NCT00788775|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).|||participants|||Number
103289|NCT00788775|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 16.2 months (90%CI 11.7-17.7 months; no/with CNS mets 16.2m/ 11.7m).|The analysis dataset is comprised of treated patients.||months||90% Confidence Interval|Median
103290|NCT00788775|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).|The analysis dataset is comprised of treated patients.||months||90% Confidence Interval|Median
103291|NCT00788775|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of treated patients.||proportion of patients||90% Confidence Interval|Number
103295|NCT00788593|Secondary|Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."||kg/m^2||Standard Deviation|Mean
103296|NCT00788593|Secondary|Change From Placebo Baseline in Weight at End of Each Treatment Period|Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||kilogram (kg)||Standard Deviation|Mean
103297|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment|Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least one dose of the study drug. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."||percent CNA||Standard Deviation|Mean
103298|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."||percent CFA||Standard Deviation|Mean
103299|NCT00788593|Primary|Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.|3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."||percent CFA||Standard Deviation|Mean
103300|NCT00787644|Primary|PC20|"Airway reactivity will be measured with methacholine challenge testing following ATS guidelines.~This is the concentration of methacholine that produces a 20% decrease in lung function (measured by forced expiratory volume in 1 second)"|12 weeks|||mg/ml||Standard Deviation|Median
103301|NCT00787618|Primary|Cmax of Proellex||48 hours|Study prematurely terminated|||||
103302|NCT00787605|Secondary|Evaluate the Safety and Tolerability|Percentage of patients with Adverse Event and percentage of patients with edema|after 8 weeks of treatment|safety||Percentage of participants|||Number
103303|NCT00787605|Secondary|Biomarker Measurements|Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)|Baseline and Week 8|Full analysis set, intent-to-treat||ratio||95% Confidence Interval|Geometric Mean
103304|NCT00787605|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure < 130/80 mmHg.|after 8 weeks of treatment|Full analysis set, intent-to-treat||Percentage of Participants|||Number
103305|NCT00787605|Secondary|Percentage of Responders|Response defined by mean sitting Systolic Blood Pressure < 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure >= 20 mm Hg from baseline|Week 8|Full analysis set, intent-to-treat||Percentage of Participants|||Number
103306|NCT00787605|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline and Week 8|Full analysis set, intent-to-treat||mmHg||Standard Error|Least Squares Mean
103307|NCT00787605|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set, intent-to-treat||mmHg||Standard Error|Least Squares Mean
103308|NCT00788372|Primary|Brief Pain Inventory-Short Form (BPI-SF) Total Score|The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
103389|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103429|NCT00787241|Secondary|Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia|Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.|1 week to time of neuraxial analgesia|||Hours||Full Range|Median
103309|NCT00788372|Primary|Participants Overall Assessment|The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
103310|NCT00788372|Primary|Physician’s Global Assessment Scale|The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.||participants|||Number
103311|NCT00788372|Primary|Short-Form 36-Item Health Survey (SF-36) Scores|The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
103312|NCT00788372|Primary|Number of Rescue Treatments|Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.||treatments per day||Standard Deviation|Mean
103313|NCT00788372|Primary|Number of Participants With Quality of Sleep|The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
103314|NCT00788372|Primary|Number of Participants With Total Painful Time Per Day|The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
103315|NCT00788372|Primary|Number of Participants With Pain Assessed by Categorical Scale for Pain|Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable).|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
103316|NCT00788372|Primary|Pain Visual Analogue Scale Score|"Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Week 52 or end point (early discontinuation)|Full Analysis Set (FAS) population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.||mm||Standard Deviation|Mean
103317|NCT00788372|Primary|Dependence Questionnaire (DQ)|The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug.|Week 52 or end point (early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale|||Number
103390|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103318|NCT00788372|Primary|Questionnaire of Opioid Withdrawal Symptoms|Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal.|Week 52 or endpoint (1 week after last treatment or early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
103319|NCT00788255|Primary|TTG|thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)|6 months|||mm||Standard Deviation|Mean
103320|NCT00788255|Primary|Tmax|thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)|6 months|||minutes||Standard Deviation|Mean
103321|NCT00788255|Primary|MRTG|thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)|6 months|||mm/min||Standard Deviation|Mean
103322|NCT00788255|Primary|MA|thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)|6 months|||mm||Standard Deviation|Mean
103323|NCT00788255|Primary|Alpha Angle|thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)|6 months|||degrees||Standard Deviation|Mean
103324|NCT00788255|Primary|k Time|thromboelastographic indices - clot formation time (normal range, 1-3 min)|6 months|||minutes||Standard Deviation|Mean
103325|NCT00788255|Primary|r Time|thromboelastographic indices - reaction time (normal range, 5-10 min)|6 months|||minutes||Standard Deviation|Mean
103326|NCT00788073|Post-Hoc|ABC-FXS Social Avoidance Subscore|After completion of the study, but during data analysis, the ABC-C assessment was independently re-validated in Fragile X Syndrome subjects. The subscales were re-factored into a Fragile-X Syndrome specific ABC-C (ABC-FX). The ABC-FX contains the same 58 questions as the original ABC-C but there are six subscales. One of the subscales is Social Avoidance, which consists of 4 items. Minimum score is 0, maximum is 12. A decreased score indicates fewer social avoidant behaviors. A post-hoc analysis was performed from the study data examining the social avoidance subscale of the ABC-FX.|4 week treatment period|||Points on a scale||Standard Error|Least Squares Mean
103327|NCT00788073|Primary|Aberrant Behavior Checklist Irritability Subscore|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|After 4 weeks of treatment|||Points on a scale||Standard Error|Least Squares Mean
103328|NCT00788008|Primary|Change in Neurocognitive Performance (Z-score)|"Mean change on composite scores (z-score) for memory and executive function measures.~Memory measures: Hopkins Verbal Learning Test–Revised and the Brief Visuospatial Memory Test–Revised.~Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination.~The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range.~Higher scores (and thus positive change value) indicate an improvement of function."|3 months post operatively|||z score||Full Range|Mean
103329|NCT00787943|Primary|Number of Inflammatory Lesions (Papules and Pustules)|Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.|4 Weeks|Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.||Lesions|||Number
103330|NCT00787930|Secondary|fa ROFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.||units on a scale||Standard Deviation|Mean
103331|NCT00787930|Secondary|fa LOFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.||units on a scale||Standard Deviation|Mean
103332|NCT00787930|Secondary|Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS).|up to 12 months|Number of subjects who who had >2 on the DWM hyperintensity assessment from the Boyko classification system.||participants|||Number
104049|NCT00782379|Secondary|Overall Survival at Day 100|Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.|Day 100|20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival||participants|||Number
103333|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15.|12 months|Subjects who completed at least 4-12 months of consistent follow up appointments after stabilization from an acute manic episode. Note that 3 subjects dropped out of continuation treatment.||participants|||Number
103334|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania|Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions.|3 weeks|All subjects in an acute manic state who were treated with specified protocol.||participants|||Number
103335|NCT00787917|Secondary|Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment||percentage of participants||Standard Error|Least Squares Mean
103336|NCT00787917|Secondary|Change From Baseline in Average Oral Corticosteroid Use.||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment||mg/day||Standard Deviation|Mean
103337|NCT00787917|Secondary|Time to Steroid Free State.||12 months|No statistical analysis was performed due to insufficient study enrollment||days||Standard Deviation|Mean
103338|NCT00787917|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment||3 months, 6 months|No statistical analysis was performed due to insufficient study enrollment||Liters||Standard Error|Least Squares Mean
103339|NCT00787917|Secondary|Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment||percentage||Standard Error|Least Squares Mean
103340|NCT00787917|Primary|Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen||6 months of blinded treatment|No statistical analysis was performed due to insufficient study enrollment||percentage||Standard Error|Least Squares Mean
103341|NCT00787904|Secondary|Bone Mineral Density|Please note that the bone density measurements were done AFTER THE PRIMARY endpoints because bone mineral density changes take longer to see differences|2 years||||||
103342|NCT00787904|Primary|Percent Change in Thymus Size Measured by CT Scan||2 years|||percent change||Standard Deviation|Mean
103343|NCT00787904|Primary|Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells|(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)|2 years|||percentage of CD3 positive cells||Standard Deviation|Mean
103344|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
103345|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
103346|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
103347|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set||Scores on a scale||Standard Deviation|Mean
103348|NCT00787891|Primary|The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|36 weeks|Intention to Treat (ITT) analysis set||Percentage of patients||95% Confidence Interval|Number
103349|NCT00787891|Primary|The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|12 weeks|Intention to Treat (ITT) analysis set||Percentage of participants||95% Confidence Interval|Number
103363|NCT00787527|Primary|Phase II MTD of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days|||mg/three times daily|||Number
103364|NCT00787527|Primary|Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat|MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.|21 Days|||participants|||Number
103365|NCT00787527|Primary|Phase I Maximum Tolerated Dose (MTD) of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days|||mg/day|||Number
103366|NCT00787332|Primary|New Thrombosis, Amputation, Death, Major and Minor Bleeding||30 days|All patients receiving drug||participants|||Number
103367|NCT00787319|Other Pre-specified|Physician's Assessment of Tolerability|Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||participants|||Number
103368|NCT00787319|Other Pre-specified|Mean Number of Doses of Study Medication Received||Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||doses||Standard Deviation|Mean
103369|NCT00787319|Other Pre-specified|Duration of Treatment|Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||weeks||Standard Deviation|Mean
103370|NCT00787319|Other Pre-specified|Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.||participants|||Number
103371|NCT00787319|Other Pre-specified|Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring|Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|Safety analysis set included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.||participants|||Number
103372|NCT00787319|Secondary|Physician's Assessment of Efficacy|Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Week 104 or End of study (EOS)|FAS included all enrolled participants who received study medication.||participants|||Number
103373|NCT00787319|Secondary|Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.|Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.||participants|||Number
103374|NCT00787319|Secondary|Change From Baseline in Visual Acuity (VA) at Each Visit|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.||logMAR||Standard Deviation|Mean
103375|NCT00787319|Primary|Change From Baseline in Visual Acuity (VA) at Final Visit|Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Final Visit (Week 104 or early termination [ET])|Full analysis set (FAS) included all enrolled participants who received study medication. Missing values were imputed using last observation carried forward (LOCF) method.||logMAR||Standard Deviation|Mean
103376|NCT00787267|Secondary|Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.|||||
103377|NCT00787267|Secondary|Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.|||||
103378|NCT00787267|Secondary|Grade 3-5 Toxicity Associated With Dasatinib Treatment|Number of subjects with Grade 3-5 toxicity as assessed using NCI CTCAE criteria with the attribution of possibly, probably, or definitely related to protocol treatment.|Duration of dasatinib treatment plus 30 days|All subjects who received at least one dose of dasatinib were included in the analysis.||participants|||Number
103379|NCT00787267|Secondary|Overall Survival|Overall survival (OS) is the duration from date of consent to date of death from any cause.|Progression and survival every 6 months|All subjects who received at least one dose of dasatinib were included in the analysis.||months||95% Confidence Interval|Median
103380|NCT00787267|Primary|Tumor Response|"Tumor response rate was defined by RECIST criteria:~CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started"|2 years|Unable to determine the response for 9 subjects.||participants|||Number
103381|NCT00787254|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|Per Incidence (up to 24 months).|||participants|||Number
103382|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103383|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103384|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103385|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103386|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103387|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)|The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103388|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
104050|NCT00782379|Primary|Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)|Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence|Day 100|17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease||participants|||Number
103391|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103392|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103393|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103394|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103395|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103396|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103397|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103398|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103399|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103400|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103401|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103402|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103403|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103404|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103405|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103406|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103407|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103408|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103409|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103410|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103411|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103412|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103413|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103414|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103415|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103416|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103417|NCT00787254|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|On occurrence (up to month 24).|On days where participants did not have an occurrence of gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) and who also underwent endoscopic examination were considered censored dates. Values are from the Full Analysis Set.||participants|||Number
103428|NCT00787254|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|24 Months|Participants not taking investigational drug were not included.||participants|||Number
103418|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103419|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103420|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103421|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103422|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103423|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103424|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103425|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103426|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103427|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
103430|NCT00787241|Secondary|Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia|The positive predictive value of the platelet count closest to neuraxial analgesia with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the closest platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the closest available platelet count multiplied by 100.|0 to 72 hours following delivery|||percentage of positive platelet counts|||Number
103431|NCT00787241|Primary|Positive Predictive Value of Earliest Available Platelet Count|The positive predictive value of the earliest available platelet count with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the first platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the earliest available platelet count multiplied by 100.|0 to 72 hours following delivery|||percentage of positive platelet counts|||Number
103432|NCT00787202|Secondary|Plasma Concentration of CP-690,550|Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter [ng/mL]) to zero.|0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8|Analysis population included all participants who had at least 1 plasma concentration. N=evaluable participants for this measure.||ng/mL||Standard Deviation|Mean
103433|NCT00787202|Secondary|Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.||milligram per kilogram (mg/kg)||Standard Deviation|Mean
103434|NCT00787202|Secondary|Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.||milligram per liter (mg/L)||Standard Deviation|Mean
103435|NCT00787202|Secondary|Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.||units on a scale||Standard Deviation|Mean
103436|NCT00787202|Secondary|Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12|Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Baseline-observation-carried-forward (BOCF) was used for participants who withdrew as TF. Missing data due to reasons other than treatment failure were excluded. N=evaluable participants for the measure.||units on a scale||Standard Deviation|Mean
103437|NCT00787202|Secondary|Percentage of Participants With Endoscopic Remission|Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.||percentage of participants|||Number
103438|NCT00787202|Secondary|Percentage of Participants With Endoscopic Response|Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.||percentage of participants|||Number
103450|NCT00787150|Secondary|Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.||participants|||Number
103439|NCT00787202|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.||percentage of participants|||Number
103440|NCT00787202|Primary|Percentage of Participants With Clinical Response|Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|Full analysis set (FAS): all participants who withdrew as treatment failure (TF) or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF=non-responders. Missing data due to reason other than TF were excluded. N (number of participants analyzed)=evaluable participants for the measure.||percentage of participants|||Number
103441|NCT00787189|Secondary|Tinnitus, Hearing-related Quality of Life||up to 6 months||||||
103442|NCT00787189|Primary|Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.|Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the CID W-22 lists. The percent of total words repeated correctly for each ear was recorded and the change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.|baseline and one week|ITT analysis.||participants|||Number
103443|NCT00787150|Other Pre-specified|Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||ng/mL||Standard Deviation|Mean
103444|NCT00787150|Other Pre-specified|Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||pmol/L||Standard Deviation|Mean
103445|NCT00787150|Other Pre-specified|Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||ng/mL||Standard Deviation|Mean
103446|NCT00787150|Other Pre-specified|Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban|Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||Second||Standard Deviation|Mean
103447|NCT00787150|Other Pre-specified|Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||International normalized ratio||Standard Deviation|Mean
103448|NCT00787150|Other Pre-specified|Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||second||Standard Deviation|Mean
103449|NCT00787150|Other Pre-specified|Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|0, 2, 4 hours postdose at Week 1 and Week 8|The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.||ng/mL||Standard Deviation|Mean
103466|NCT00787020|Primary|Cerebral Artery Vasospasm|Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.|14 days|||Participants|||Number
103451|NCT00787150|Secondary|Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.||participants|||Number
103452|NCT00787150|Secondary|Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.||participants|||Number
103453|NCT00787150|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period|Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
103454|NCT00787150|Secondary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period|Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
103455|NCT00787150|Secondary|Number of Participants With Total Bleeding Events During the Treatment Period|Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
103456|NCT00787150|Primary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.||participants|||Number
103457|NCT00787137|Primary|The Number of Episodes of Change From Screening in Laboratory Assessments|Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.|Three months|||Number of episodes of change|||Number
103458|NCT00787137|Primary|The Number of Episodes of Change in Electrocardiogram|Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.|Three months|||Number of episodes of change|||Number
103459|NCT00787137|Primary|The Number of Episodes of Change in Vital Signs|Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.|Three months|||Number of episodes of change|||Number
103460|NCT00787137|Primary|The Percentage of Participants With Adverse Events||Three months|All patients dosed were evaluated||Percentage of Participants|||Number
103461|NCT00787137|Primary|The Number of Reported Adverse Events|This was an exploratory study and all safety endpoints were considered.|Three months|All adverse events reported for all patients dosed were evaluated||Number of adverse events|||Number
103462|NCT00787124|Primary|SNOHgB Levels|levels were never run by the laboratory|beginning and end of study||||||
103463|NCT00787124|Secondary|Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.|data not appropriately collected for the analysis due to machine malfunctions.|prior to, during, after transfusion||||||
103464|NCT00787020|Secondary|Cerebrospinal Fluid (CSF) Output Per Day||14 Days|||Milliliter||95% Confidence Interval|Mean
103465|NCT00787020|Secondary|External Ventricular Drain (EVD) Complications|External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.|14 Days|||Participants|||Number
103467|NCT00786994|Primary|Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.|"Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.~The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success."|18 weeks|||participants|||Number
103468|NCT00786916|Primary|Maximal Pain/Discomfort|"FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where 0 represented no pain and 100 (the furthest point to the left) represented the worst pain ever."|during initial 3 minute propofol infusion|All enrolled subjects were randomized into groups A, B or C by hospital pharmacists utilizing a standard prerandomization methodology.||units on a scale||Standard Deviation|Mean
103469|NCT00786864|Secondary|Hamstring Flexibility|Standardised hamstring muscle length test. The child was positioned in supine, with the hip flexed at 90 degrees. The knee was then extended passively. The angle of knee extension [from horizontal plane (level to plinth) to fibula] was measured using a digital inclinometer. Continuous data. Scores ranged from -20 (worst score) to 82 (best score).|3 months post-intervention|Intention to treat analysis||degrees||Standard Deviation|Mean
103470|NCT00786864|Primary|Low Back Pain Intensity|The visual analogue scale (standardised 100mm, non-hatched line) was used to determine pain intensity. Scores can range between 0 and 10, with the worst possible pain/score = 10 and no pain/best score = 0. Visual analogue scale is continuous.|3 months post-intervention|Intention to treat analysis||units on a scale||Standard Deviation|Mean
103471|NCT00786864|Secondary|Neural Mobility|Straight leg raise test was used to measure neural mobility. The amount of hip flexion (angle between the plinth and femur of the raised leg) was measured using a digital inclinometer. Scores ranged between 3 (worst score) and 90.5 (best score). Continuous data.|3 months post-intervention|Intention to treat analysis||degrees||Standard Deviation|Mean
103472|NCT00786864|Primary|Low Back Pain Prevalence|All of the children complained of low back pain at baseline. Low back pain prevalence post-intervention was determined by the number of children still complaining of low back pain post-intervention.|3 months post-intervention|Intention to treat analysis||participants|||Number
103473|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett’s Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett’s Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||milli seconds||Standard Deviation|Mean
103474|NCT00786838|Secondary|Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose||Baseline (predose on Day 1) to 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean.||beats per minute||Standard Deviation|Mean
103475|NCT00786838|Secondary|Number of Participants With QRS Interval Greater Than 120 Milli Seconds|QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
103476|NCT00786838|Secondary|Number of Participants With PR Interval Greater Than 200 Milli Seconds|PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
103477|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 500 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
103478|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 480 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
103509|NCT00786565|Primary|Low Contrast Uncorrected Visual Acuity Following Cataract Surgery|Low contrast uncorrected visual acuity 3 months post cataract surgery|3 months|Full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy||LogMAR||Standard Deviation|Mean
103479|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 450 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
103480|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
103481|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||participants|||Number
103482|NCT00786838|Secondary|Time Taken to Acheive Maximum Plasma Concentration (Tmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||hours||Standard Deviation|Mean
103483|NCT00786838|Secondary|Maximum Plasma Concentration of Trabectedin (Cmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||nanogram per milliliter||Standard Deviation|Mean
103484|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.||milli seconds||Standard Deviation|Mean
103485|NCT00786799|Secondary|Change in Serum TNFα (Cytokine) Level||Baseline and 1 year|||pg/ml||Standard Deviation|Mean
103486|NCT00786799|Secondary|Change in Percentage of Serum Omega-3 Fatty Acids|Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)|Baseline and 1 year|||Percent change of levels of fatty acid||Standard Deviation|Mean
103487|NCT00786799|Primary|Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)|Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from “no problem” to “major problem”). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.|Baseline and 1 year|||scores on a scale||Standard Deviation|Mean
103488|NCT00786682|Secondary|Overall Survival||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.|||||
103489|NCT00786682|Secondary|Time to Disease Progression||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.|||||
103490|NCT00786682|Primary|Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.|We will use a two-stage optimal Simon’s design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The “expected” sample size of the trial is 23.5 with the null response rate of 50%.|4 years|Upon reviewing response data for the first 8 patients, we noted that there were no responses thus far. As per the two-stage optimal Simon's design, we would need 8 responses in 15 patients to proceed to stage 2 but we would not have crossed that threshold. The study was stopped due to lack of improved efficacy compared to historical controls.|||||
103491|NCT00786643|Secondary|Time to Progression|Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months|||Months||95% Confidence Interval|Median
104051|NCT00782379|Primary|Incidence of Graft Rejection for Patients at Day 100|Number of patients who experienced graft rejection by Day 100|Day 100|20 patients were treated and able to be analyzed for graft rejection||participants|||Number
103492|NCT00786643|Secondary|Early Response Rate (RR) (Stratum 1 Only)|Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.|After 4 cycles of treatment (approximately 56 days)|Prior to the 5th cycle of treatment, early response rate was evaluated in patients in stratum 1 to assess whether bevacizumab would be added to the GFL treatment regimen. Stratum 1 patients with SD at this time point will have bevacizumab added to the regimen. Subjects in stratum 2 were not evaluated for this outcome.||Participants|||Number
103493|NCT00786643|Primary|Best Response (BR)|BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.|After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)|The best response is the best response recorded from the start of treatment until disease progression. Imaging was repeated by same technique after every 4 cycles of treatment. Subjects in both strata were evaluated for this outcome.||Participants|||Number
103494|NCT00786565|Secondary|Posterior Capsule Opacification|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|12 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.||EPCO Score||Standard Deviation|Mean
103495|NCT00786565|Secondary|Contrast Sensitivity Mesoptic|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
103496|NCT00786565|Secondary|Contrast Sensitivity Mesoptic 1.5 Cpd|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
103497|NCT00786565|Secondary|Contrast Sensitivity Photopic|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
103498|NCT00786565|Secondary|Contrast Sensitivity Photopic 1.5cpd|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
103499|NCT00786565|Secondary|Low Contrast Visual Acuity|Uncorrected Low contrast visual acuity - LogMar visual acuity value|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||LogMar||Standard Deviation|Mean
103500|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||24 Months|Patients without missing values for best corrected HCVA logmar at pre-operative and post operative at 1 month control.||LogMar||Standard Deviation|Mean
103501|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||24 Months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.||LogMar||Standard Deviation|Mean
103502|NCT00786565|Primary|Posterior Capsule Opacification Score|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|24 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.||EPCO Score||Standard Deviation|Mean
103503|NCT00786565|Primary|Mesoptic Contrast Sensitivity|The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 Months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
103504|NCT00786565|Secondary|High Contrast Visual Acuity||12 months|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
103505|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||3 months|Patients without missing values for BHCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
103506|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||3 months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
103507|NCT00786565|Secondary|High Contrast Visual Acuity|High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.|1 month|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.||LogMAR||Standard Deviation|Mean
103508|NCT00786565|Primary|Photopic Contrast Sensitivity|The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.||Log 10||Standard Deviation|Mean
104772|NCT00774397|Secondary|Change From Baseline to Week 24 in Pulse Rate|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Pulse rate at Week 24)||bpm||Standard Deviation|Mean
103510|NCT00786565|Primary|Low Contrast Best Corrected Visual Acuity Following Cataract Surgery|Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.|3 months|Number of participants 67 total with 67 eyes in each group, full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy.||LogMAR||Standard Deviation|Mean
103511|NCT00786487|Primary|Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion|Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)|at 6 hours after starting lipid/glycerol infusion|||M value||Standard Deviation|Mean
103512|NCT00786474|Secondary|Number of Participants With Minor Bleeding|Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data||participants|||Number
103513|NCT00786474|Secondary|Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism||from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.||participants|||Number
103514|NCT00786474|Primary|Major Bleeding|Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.||participants|||Number
103515|NCT00786474|Primary|Number of Arterial Thromboembolic Events|The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.||Arterial thromboembolic events|||Number
103516|NCT00786422|Secondary|Percentage of Participants With Other Vascular Events|All events were adjudicated and confirmed by a central independent adjudication committee. Other vascular events comprised ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), unstable angina (UA), ischemic stroke, transient ischemic attack (TIA), non-central nervous system systemic embolism and vascular death.|Up to 3 months treatment and during subsequent 1 day|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.||Percentage of participants|||Number
103517|NCT00786422|Secondary|Percentage of Participants With Treatment Emergent Deaths - 7 Days Window|Treatment emergent deaths were adjudicated by a central independent adjudication committee. Participants who died from treatment emergent adverse events were counted for this measure.|Up to 3 months treatment and during subsequent 7 days|All participants||Percentage of participants|||Number
103518|NCT00786422|Secondary|Percentage of Participants With All Deaths|All deaths were adjudicated by a central independent adjudication committee. Participants who died for any reason were counted for this measure.|Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month|All participants||Percentage of participants|||Number
103519|NCT00786422|Secondary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee. The composite efficacy outcome symptomatic recurrent VTE was analyzed descriptively, with the components: Death due to PE, death for which PE cannot be excluded, symptomatic PE and DVT, symptomatic recurrent PE only, and symptomatic recurrent DVT only up to the end of intended treatment period (3 months; 98 study days) and on-treatment (up to 2 days after stop of study drug).|Up to 3 months treatment and during subsequent 30-day observational period for an individual participant|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.||Percentage of participants|||Number
103520|NCT00786422|Primary|Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)|All events were adjudicated and confirmed by a central independent adjudication committee. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|Up to 3 months treatment and during subsequent 2 days|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.||Percentage of participants|||Number
103521|NCT00786422|Primary|Pharmacokinetics – Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmin,ss was predicted for each individual participant from rivaroxaban plasma concentrations and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||µg/L||90% Confidence Interval|Median
103522|NCT00786422|Primary|Pharmacokinetics – Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmax,ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||µg/L||90% Confidence Interval|Median
104618|NCT00775528|Secondary|Fat Intake (g)|The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.||Grams||Standard Deviation|Mean
103523|NCT00786422|Primary|Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban|AUC(0-24)ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||(µg*h)/L||90% Confidence Interval|Median
103524|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Slope|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out of PT is in seconds. The PT slope describes the linear increase of PT for one unit increase in concentration, thus the unit of PT slope is s*(µg/L)^-1. The final population PK/PD model included a fixed slope that was fitted to the data of the 19 patients that were eligible for evaluation. The estimated mean value (fixed/ the same for all patients in this study) is presented for PT slope.|Up to 3 months treatment|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||s*(µg/L)^-1|||Number
103525|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Baseline Value|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Mean and standard deviation (SD) values are presented for PT baseline.|The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration||Seconds||Standard Deviation|Mean
103526|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8|Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.|Week 4 and Week 8|||BMI Kg/m2||Standard Error|Mean
103527|NCT00786188|Secondary|Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8|"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.~The measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question."|Week 4 and Week 8|||Percentage of true responders|||Number
103528|NCT00786188|Secondary|Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.|Week 8|||units on a scale||Standard Error|Mean
103529|NCT00786188|Secondary|Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8|The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 4 and Week 8|||Percentage of participants|||Number
103530|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4|"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question."|Week 4|||percentage of responders|||Number
103531|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4|"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 335.~The percentage of participants who had a change from baseline in the total score at Week 4 is reported below."|Week 4|||percentage of participants|||Number
103532|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8|"Depression & anxiety were measured using the Hospital Anxiety & Depression Scale (HADS).~The HADS is a scale developed to assess anxiety & depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.~The results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression combined at Week 8."|Week 8|||participants|||Number
103533|NCT00786188|Secondary|Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8|"A scale was not used for this measurement.~Composite scores of hot flashes were calculated by using the following formula:~CS = (2 • Fm + 3 • Fs)~Where:~CS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score."|Week 4 and Week 8|||Composite score||Standard Error|Mean
103534|NCT00786188|Secondary|Change From Baseline in Climacteric Symptoms at Week 8|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 8|||units on a scale||Standard Error|Mean
103535|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8|"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.~SS = (2•Fm + 3•Fs) ÷ (Fm + Fs)~Where:~SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score."|Week 4 and Week 8|||Severity score||Standard Error|Mean
103536|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8|"The number of hot flashes reported in the result table are:~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week."|Week 4 and Week 8|MODIFIED ITT (MITT) POPULATION Brisdelle 49 (98.0%) Placebo 52 (100.0%) PER PROTOCOL (PP) POPULATION Brisdelle 45 (90.0%) Placebo 51(98.1%)||Hot flashes||Standard Error|Mean
103537|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by selection rate. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g, THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The number of selections/min for the BCI applications was averaged across users.|Up to 18 months|||number of selection per minute||Standard Deviation|Mean
103538|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by accuracy. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g., THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The independent-use periods of the 14 independent users was totaled by days. Of these days, BCI use was not possible for days (i.e. hiatus days) due to hospitalization, illness, home construction, travel, or BCI system assistant (SA) absence. Over these days, copy-spelling accuracy was averaged.|Up to 18 months|||percentage of days||Standard Deviation|Mean
103539|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by time per application.|Up to 18 months|||percentage of BCI time||Standard Deviation|Median
103540|NCT00786032|Secondary|Facility Support Speed of Solution|This study will look at how the technical problems of the BCI are supported by the facility through analyzing the speed of solution.|Up to 18 months|||hours||Standard Deviation|Mean
103541|NCT00786032|Secondary|Time of BCI Impact on the Significant Other and Systems Operator|The quality of life of the significant other, caregiver and system operator will be measured using the Caregiver Burden Assessment at visits. At three month intervals, the significant other, caregiver and system operator will be asked to estimate how much time they spend on the following tasks per day in minutes: BCI System setup ( placing the electrode cap and initiating system operation), BCI System cleanup, and BCI System maintenance (removing cap).|Up to 18 months|||minutes||Standard Deviation|Mean
103542|NCT00786032|Secondary|BCI Usage by and Impact on the ALS Patient|At three-month intervals, BCI use will be summarized. On a daily basis the BCI will record the total of number of selections made in copy spelling mode. Copy spelling mode is used for system calibration. Participants are expected to indicate that the burden associated with BCI use is inconsequential to the benefit derived from using the BCI. This will be assessed by the McGill Quality of Life (MQOL) at each visit.|Up to 18 months|||units on a scale||Standard Deviation|Mean
103543|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.|Up to 18 months|||days||Standard Deviation|Mean
103544|NCT00785980|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on 20 subjects out of the 21 subjects who completed the study. One value was determined to be unreliable and was not used.||ng-hr/mL||Standard Deviation|Mean
103545|NCT00785980|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|||ng-hr/mL||Standard Deviation|Mean
103598|NCT00784927|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.|||months||95% Confidence Interval|Median
103546|NCT00785980|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on twenty-one (21) subjects who successfully completed the study. Three (#3) subjects were dropped by the sponsor due to protocol violation.||ng/mL||Standard Deviation|Mean
103547|NCT00785798|Primary|Number of Subjects With Stable Disease (SD)||2 years|||participants|||Number
103548|NCT00785798|Primary|Number of Subjects With Progressive Disease (PR)||2 years|||participants|||Number
103549|NCT00785785|Primary|Time to Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to month 37|Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.||months||Full Range|Median
103550|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration|Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.||Ratio|||Number
103551|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model|Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.||Ratio|||Number
103552|NCT00785772|Primary|Observed Plasma Gabapentin Concentration|Plasma gabapentin concentrations were measured on Day 8 and Day 15|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.||µg/mL||Full Range|Mean
103553|NCT00785629|Primary|Serum Phosphorus|mean serum phosphorus from months 3-9|months 3-9|ITT analysis was ALL active patients combined versus all placebo patients combined||mg/dL||Standard Deviation|Mean
103554|NCT00785577|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.||participants|||Number
103555|NCT00785577|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||time (days)|||Number
103556|NCT00785577|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
103557|NCT00785577|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.||participants|||Number
103558|NCT00785577|Secondary|Number of Participants With Suicidal Behaviors and Ideations|"The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a yes answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation."|Baseline through week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||participants|||Number
103559|NCT00785577|Secondary|Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score|The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103560|NCT00785577|Secondary|Percentage of Participants With Reported Hypoglycemic Events|"Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the Investigations system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.||percentage of participants|||Number
103561|NCT00785577|Secondary|Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||participants|||Number
103562|NCT00785577|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||beats per minute (bpm)||Standard Error|Least Squares Mean
103563|NCT00785577|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
103564|NCT00785577|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.||participants|||Number
103565|NCT00785577|Secondary|Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 273 participants randomized to study drug.||participants|||Number
103566|NCT00785577|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103567|NCT00785577|Secondary|Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103568|NCT00785577|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants’ quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103569|NCT00785577|Secondary|Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks|NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5‑point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3‑point bothersome/importance scale (1=none to 3=very).|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103570|NCT00785577|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
104827|NCT00773786|Secondary|Change From Baseline in Inspiratory Capacity at 1 Week|Change from baseline in Inspiratory Capacity (IC) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline).|baseline and 2 hours after dosing|||Liters||Standard Error|Mean
103571|NCT00785577|Secondary|Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks|SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103572|NCT00785577|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.||units on a scale||Standard Error|Least Squares Mean
103573|NCT00785577|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103574|NCT00785577|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103575|NCT00785577|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103576|NCT00785577|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.||participants|||Number
103577|NCT00785577|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103578|NCT00785577|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.||units on a scale||Standard Error|Least Squares Mean
103579|NCT00785577|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.||units on a scale||Standard Error|Least Squares Mean
103580|NCT00785512|Secondary|Trough Sitting Systolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)|||mm HG||Standard Deviation|Mean
103581|NCT00785512|Primary|Trough Sitting Diastolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)|||mm HG||Standard Deviation|Mean
103674|NCT00784654|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At Week 26|Open-label FAS||percentage of participants|||Number
103582|NCT00785486|Primary|The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam|Qualaquin (quinine) - AUC tau alone at steady state (day 9) and in the presence of coadministered midazolam 2 mg (day 10) over the dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.|Days 9 and 10 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours|per protocol||ng•h/mL||Standard Deviation|Mean
103583|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to Infinity (AUC Inf) for Midazolam and 1 Hydroxy Midazolam Before (Day 1) and After (Day 10) Qualaquin (Quinine).|AUC inf for Midazolam and hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with steady state Qualaquin(quinine)- the sum of AUC0-t plus the ratio of the last measured plasma concentration to the elimination rate constant to determine whether a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|per protocol||ng·h/mL||Standard Deviation|Mean
103584|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to T (AUC 0-t) for Midazolam and 1-hydroxy Midazolam at Baseline and With Qualaquin (Quinine) at Steady State.|Area under the concentration time curve(AUC 0-t) calculated by the linear trapezoidal method from time 0 to 24 hours, for Midazolam and 1-hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with Qualaquin -(quinine) at steady state to determine if a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|by protocol||ng•h/mL||Standard Deviation|Mean
103585|NCT00785486|Primary|Maximum Serum Concentration (Cmax)|Maximum serum concentration(Cmax)|Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine)|per protocol||ng/ml||Standard Deviation|Mean
103586|NCT00785356|Primary|The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.||3 months||||||
103587|NCT00785291|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization to death or last follow-up (up to 5 years)|||months||95% Confidence Interval|Median
103588|NCT00785291|Secondary|12 Month Progression Free Survival|Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|12 months|Participants who never began protocol treatment were excluded.||percentage of participants||95% Confidence Interval|Number
103589|NCT00785291|Secondary|Time to Treatment Failure|Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)|Participants who never began protocol treatment were excluded.||months||95% Confidence Interval|Median
103590|NCT00785291|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).|Up to 5 years|||percentage of participants|||Number
103591|NCT00785291|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)|Participants who never began protocol treatment were excluded.||months||95% Confidence Interval|Median
103592|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.||ug-hr/mL||Standard Deviation|Mean
103593|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.||ug-hr/mL||Standard Deviation|Mean
103594|NCT00785213|Primary|Maximum Plasma Concentration (Cmax) of Rosiglitazone|The maximum or peak concentration that rosiglitazone reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.||ug/mL||Standard Deviation|Mean
103595|NCT00784979|Secondary|Monitor Patient Survival||5 years||||||
103596|NCT00784979|Secondary|Monitor Graft Survival||5 years||||||
103597|NCT00784979|Primary|The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor|The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.|four weeks|||percent of subjects becoming compatible|||Number
103599|NCT00784927|Secondary|Progression-free Survival Time|"Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death.~Progressive disease is defined as having one of the following:~The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Up to 1 year from registration.|||months||95% Confidence Interval|Median
103600|NCT00784927|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.|||months||95% Confidence Interval|Median
103601|NCT00784927|Secondary|Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom’s Macroglobulinemia).|"The proportion of responses in Waldenstrom's macroglobulinemia was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.|||percentage of participants||95% Confidence Interval|Number
103602|NCT00784927|Primary|Assessment of Tumor Response|"The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.|||percentage of participants||95% Confidence Interval|Number
103603|NCT00784875|Secondary|Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||milliseconds||Standard Error|Least Squares Mean
103604|NCT00784875|Secondary|Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||beats per minute||Standard Error|Least Squares Mean
103605|NCT00784875|Secondary|Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint|Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).|2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.||participants|||Number
103606|NCT00784875|Secondary|Change From Baseline in Weight at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||kilogram||Standard Error|Least Squares Mean
103607|NCT00784875|Secondary|Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||beats per minute||Standard Error|Least Squares Mean
103608|NCT00784875|Secondary|Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||mmHg||Standard Error|Least Squares Mean
103609|NCT00784875|Secondary|Number of Participants With Serious Adverse Events (SAEs)|SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.||participants|||Number
103610|NCT00784875|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.||participants|||Number
103611|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group|Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline through 8 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.||participants||Standard Error|Least Squares Mean
103612|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline, 2 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.||minutes||Standard Error|Least Squares Mean
103613|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type|Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline through 8 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.||participants|||Number
103614|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline, 2 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.||minutes||Standard Error|Least Squares Mean
103615|NCT00784875|Secondary|Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||percentage of participants|||Number
103616|NCT00784875|Secondary|Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||percentage of participants|||Number
103617|NCT00784875|Secondary|Treatment Satisfaction as Measured by the Participant Drug Preference Question|After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.|Baseline (Period A) and 2 weeks (Period B)|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||percentage of participants|||Number
103618|NCT00784875|Secondary|Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint|The EuroQoL Questionnaire–5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
103619|NCT00784875|Secondary|Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
103620|NCT00784875|Secondary|Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint|The ISI is a brief self-report instrument that measures a participant’s perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
103675|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||Scores on a scale||Standard Error|Least Squares Mean
103621|NCT00784875|Secondary|Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint|DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
103622|NCT00784875|Secondary|Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint|Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||units on a scale||Standard Error|Least Squares Mean
103623|NCT00784875|Secondary|Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint|Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||ratio||Standard Error|Least Squares Mean
103624|NCT00784875|Secondary|Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint|Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||minutes||Standard Error|Least Squares Mean
103625|NCT00784875|Secondary|Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint|Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||number of awakenings||Standard Error|Least Squares Mean
103626|NCT00784875|Secondary|Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint|Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||minutes||Standard Error|Least Squares Mean
103627|NCT00784875|Primary|Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.||minutes||Standard Error|Least Squares Mean
103628|NCT00784849|Secondary|Superficial Skin Necrosis|the number of participants who developed post-operative skin necrosis within 2 weeks of surgery|2 weeks postoperatively|||participants|||Number
103629|NCT00784849|Secondary|Safety (Allergic Reaction to Blue Dye)|number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension|intraoperatively up to 6 hours|||participants|||Number
103630|NCT00784849|Primary|The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)||intraoperatively; up to 6 hours|||participants|||Number
103631|NCT00784836|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Planned for up to 18 months plus 30 days; actual study duration was 111 days.|||participants|||Number
103688|NCT00784563|Secondary|Change in 7 Meter Walk Time|Time complete the 7 m Walk test after 6 months aerobic training - Time complete the 7 m Walk test at baseline|6 months|See PMID: 24991037||seconds||Standard Deviation|Mean
103632|NCT00784836|Primary|Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)|The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.|assessed every 3 months up to 18 months|The study was terminated early before any of the 3 enrolled subjects completed the study; therefore, no statistical analysis was performed.|||||
103633|NCT00784810|Secondary|Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.|"To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the number of intakes of rescue medication for this period (ie between Visit 8 and Visit 9)."|Between visit 8 and 9|The number of participants for analysis is less due to subject withdrawals or lack of data.||Number of rescue medication intakes||Standard Deviation|Mean
103634|NCT00784810|Primary|Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)|The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)|Average daily pain over last 24 hours (at Week 12)|To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data.||Units on a BS-11 scale at Week 12||Standard Deviation|Mean
103635|NCT00784784|Primary|Number of Laboratory Confirmed Influenza Infections|Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)|6 months|intention to treat||infections|||Number
103636|NCT00784784|Secondary|Number of Subjects Adhering to Long-term Zanamivir Prophylaxis|Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).|5 months|ITT||participants||95% Confidence Interval|Number
103637|NCT00784719|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8|NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||Units on a scale||Standard Deviation|Mean
103638|NCT00784719|Secondary|Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8|mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.|||||
103639|NCT00784719|Secondary|Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).|Baseline, Week 1, 2, 4, 6, 8|Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.|||||
103640|NCT00784719|Secondary|Percentage of Participants With >= 10 Units Decrease in Total OSDI Score|OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
103641|NCT00784719|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here ‘N’ (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
103642|NCT00784719|Secondary|Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8|Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||drops/day||Standard Deviation|Mean
103643|NCT00784719|Secondary|Percentage of Participants With >= 5 Units Decrease in Total OCI Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
103644|NCT00784719|Secondary|Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
103645|NCT00784719|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8|TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||seconds||Standard Deviation|Mean
103646|NCT00784719|Secondary|Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8|Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
103647|NCT00784719|Secondary|Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining|Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
103648|NCT00784719|Secondary|Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8|Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
103649|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
103650|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6|ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.||percentage of participants|||Number
103689|NCT00784563|Primary|Change in Aerobic Fitness|"VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting).~Please see publication PMID: 24991037 for details."|6 months|Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for all analyses.||ml/min/kg||Standard Deviation|Mean
103651|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||mm||Standard Deviation|Mean
103652|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.||mm||Standard Deviation|Mean
103653|NCT00784719|Secondary|Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
103654|NCT00784719|Secondary|Time to Achieve 100 Percent (%) Clearance of Corneal Staining|Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
103655|NCT00784719|Secondary|Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||days||95% Confidence Interval|Median
103656|NCT00784719|Primary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.||percentage of participants|||Number
103657|NCT00784719|Primary|Percentage of Participants With Ocular Tolerability Assessment|Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).|Baseline up to Week 8|ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants|||Number
103658|NCT00784719|Primary|Percentage of Participants With Ocular Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.|Baseline up to Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
103659|NCT00784719|Primary|Percentage of Participants With Systemic Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.|Baseline up to Week 8|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
103660|NCT00784654|Other Pre-specified|C-SSRS During the Randomized Withdrawal Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks)|Randomized Safety Population||participants|||Number
103661|NCT00784654|Other Pre-specified|Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|From open-label baseline to Week-26|Open-label Safety Population||participants|||Number
103662|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Randomized Withdrawal Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Randomized withdrawal baseline|Randomized FAS||percentage of participants|||Number
103663|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Safety Population includes all subjects who received at least 1 dose of any investigational product during the Randomized Withdrawal Period||Scores on a scale||Standard Deviation|Mean
103664|NCT00784654|Secondary|Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label Safety Population includes all subjects who received at least 1 dose of investigational product in the Open-label period.||Scores on a scale||Standard Deviation|Mean
103665|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||Scores on a scale||Standard Error|Least Squares Mean
103666|NCT00784654|Secondary|Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS||scores on a scale||Standard Deviation|Mean
103667|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||T-scores||Standard Error|Least Squares Mean
103668|NCT00784654|Secondary|Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS||T-scores||Standard Deviation|Mean
103669|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS||Scores on a scale||Standard Deviation|Mean
103670|NCT00784654|Secondary|Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS||scores on a scale||Standard Deviation|Mean
103671|NCT00784654|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period|"Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.~Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories."|At Week 26|Open-label FAS||percentage of improved participants|||Number
103672|NCT00784654|Secondary|Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At endpoint of the randomized withdrawal period (Up to 6 weeks)|Randomized FAS||percentage of participants|||Number
103673|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Open-label baseline|Open-label FAS||percentage of participants|||Number
104828|NCT00773786|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at 1 Week|Change from baseline in Forced Vital Capacity (FVC) after 1 week on Brovana or Placebo. (Change = 1 week - baseline)|baseline and 1 week|||Liters||Standard Error|Mean
103676|NCT00784654|Secondary|Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Open-label baseline and Endpoint (Week-26)|Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period.||Scores on a scale||Standard Deviation|Mean
103677|NCT00784654|Primary|Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period|"Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period.~Subjects without an endpoint value were classed as treatment failures."|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period.||percentage of participants|||Number
103678|NCT00784563|Other Pre-specified|Change in LEDD (Levodopa Equivalent Daily Dose)|=amount after 6 months training - amount at baseline Total antiparkinsonian treatment daily dose expressed in levodopa equivalents per Tomlinson et al (PMID:21069833). Higher scores are worse.|6 months|||mg/day||Standard Deviation|Mean
103679|NCT00784563|Secondary|Change in Percent Increase Score (PIS) on Eriksen's Flanker Task|performance on the Eriksen's flanker task (see PMID: 24991037). Participants were asked to identify the orientation of a central arrow cue (‘<’ or ‘>’), which was flanked on both sides by two arrow cues that either pointed in the same direction (congruent: <<<<<) or a different direction (incongruent: >><>>). Using reaction times (RT) during congruent and incongruent trials, the PIS was calculated as =((RT_incongruent – RT_congruent) / RT_congruent) * 100. Higher PIS is worse.|6 months|||Percentage of Increase score||Standard Deviation|Mean
103680|NCT00784563|Secondary|Change in the MOCA Score|=Score after 6 months training - baseline score. MOCA=Montreal Cognitive Training Assessment Scores range 0-30, higher is better.|6 months|||units on a scale||Standard Deviation|Mean
103681|NCT00784563|Secondary|Change in the Total UPDRS Score|"=Score after 6 months training - baseline score The total UPDRS score is calculated by adding Section I, Section II, and Section III scores (below). Higher scores are worse. The score ranges 0-176.~Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108."|6 months|||units on a scale||Standard Deviation|Mean
103682|NCT00784563|Secondary|Change in the UPDRS Section III Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
103683|NCT00784563|Other Pre-specified|Change in Parkinson’s Disease Quality of Life Scale (PDQUALIF) Score|= PDQUALIF score after 6 months training - baseline score The PDQUALIF is a 32 item questionnaire resulting in 7 factors. . Subjects rate themselves between 1 (most favorable) and 5 (least favorable) on a Likert scale. Factor scores are standardized to100 and lower scores are better. The outcome measure is the average of these 7 factor scores.|6 months|||units on a scale||Standard Deviation|Mean
103684|NCT00784563|Other Pre-specified|Change in Geriatric Depression Scale Score|=Score after 6 months training - score at baseline. The Geriatric Depression Scale (GDS)-short form is a 15 item yes/no questionnaire. The range is 0-15 and scores >5 suggest depression. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
103685|NCT00784563|Other Pre-specified|Change in Fatigue Severity Scale Score|=Score after 6 months of training - baseline score. The Fatigue Severity Scale (FSS) is a self-administered unidimensional generic 9-item fatigue rating scale. These are rated on a seven-grade Likert scale of which only the respective ends are defined (‘‘completely disagree’’=1 to ‘‘completely agree’’=7). The total FSS score represents the mean score of each of the nine items, yielding a score range between 1 and 7, higher scores indicating a higher level of fatigue.|6 months|||units on a scale||Standard Deviation|Mean
103686|NCT00784563|Secondary|Change in UPDRS Section II Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
103687|NCT00784563|Secondary|Change in the UPDRS Section I Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months|||units on a scale||Standard Deviation|Mean
103690|NCT00784550|Secondary|Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint|The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.|Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)|ITT Population||points on a scale||Standard Error|Mean
103691|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)|ITT Population||ml||Standard Error|Mean
103692|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).|Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)|ITT Population||ml||Standard Error|Mean
103693|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.|Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)|ITT Population||ml||Standard Error|Mean
103694|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)|ITT Population||ml||Standard Error|Mean
103695|NCT00784550|Primary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)|Intent-to-Treat (ITT) Population: all participants randomized to study drug||milliliters (ml)||Standard Error|Mean
103696|NCT00784459|Primary|Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept||3 months|||percentage of cells||Standard Deviation|Mean
103697|NCT00784459|Primary|Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge|collected prior to randomization to abatacept or placebo|baseline|||percentage of cells||Standard Deviation|Mean
103698|NCT00784368|Secondary|Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment)|Level of Improvement in Endoscopy was assessed as disappeared, decreased, improved, no change, worsened and could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
103699|NCT00784368|Secondary|Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment|Level of Improvement in the Endoscopy or Image diagnosis was assessed as disappeared (if the abnormal findings were normalized), decreased (if level of pathogenic fungus was decreased in culture), improved (if significant improvement was observed in the abnormal findings), no change (if no significant improvement was observed in the abnormal findings), worsened (if the abnormal findings were worsened) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
103700|NCT00784368|Secondary|Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment)|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), worsened (if the test values increased) and could not be assessed (if it was difficult to make above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
103735|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <200 Copies/mL at Week 24|This measure was assessed in the same manner as the primary efficacy analysis for the proportion of patients achieving HIV-1 RNA levels below 200 copies/mL at Week 24 of the study.|Week 24|||percentage of patients|||Number
103701|NCT00784368|Secondary|Number of Participants With Serological Effect Against Fungi by Centralized Assessment|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), no change (if there was no change in the test values) , worsened (if the test values increased) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
103702|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment)|Mycological efficacy was assessed as disappeared, decreased, no change, increased, could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
103703|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Centralized Assessment|Mycological efficacy was assessed as disappeared (if results for pathogenic fungus became negative, or if it was not possible to obtain the appropriate specimens), decreased (if level of pathogenic fungus was decreased in culture), no change (if there was no quantitative change in pathogenic fungus), increased (if there was a quantitative increase in pathogenic fungus, if results for pathogenic fungus became positive after start of dosing or if new pathogenic fungus was identified) , could not be assessed (if it was difficult to make the above assessment due to lack of detection in tests).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
103704|NCT00784368|Secondary|Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment)|E.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and number of cases for whom treatment was judged to be ineffective multiplied by 100. T.S.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, number of cases for whom treatment was judged to be ineffective and number of cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||percentage of participants||95% Confidence Interval|Number
103705|NCT00784368|Secondary|Percentage of Participants With Overall Response by Centralized Assessment|Efficacy rate (E.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and cases for whom treatment was judged to be ineffective multiplied by 100. Treatment success rate (T.S.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, cases for whom treatment was judged to be ineffective and cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||percentage of participants||95% Confidence Interval|Number
103706|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment)|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, chronic necrotic pulmonary aspergillosis (C.N.P.A), pulmonary aspergilloma (P.A.) and pulmonary cryptococcosis (P.C).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||participants|||Number
103707|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Centralized Assessment|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.||participants|||Number
103708|NCT00784368|Primary|Time Above Minimum Inhibitory Concentration (T>MIC)|The T>MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||percent time||Standard Deviation|Mean
103709|NCT00784368|Primary|Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)|The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||hour||Standard Deviation|Mean
103710|NCT00784368|Primary|Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)|The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||ratio||Standard Deviation|Mean
103711|NCT00784368|Primary|Minimum Inhibitory Concentration (MIC)|The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.||mcg per ml||Standard Deviation|Mean
103712|NCT00784368|Primary|Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])|The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg*hour(hr) per ml.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population, for SFI (ITCZ-OS). Here 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||mcg*hr per ml||Standard Deviation|Mean
103713|NCT00784368|Primary|Maximum Plasma Itraconazole Concentration (Cmax)|The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|Pharmacokinetic (PK) analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population for SFI (ITCZ-OS). 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.||mcg/ml||Standard Deviation|Mean
103714|NCT00784277|Primary|Spontaneous Bowel Movements Per Week (SBMs/Week)|The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.|Week 1 to Week 2|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).||number of stools/week||Standard Deviation|Mean
103715|NCT00784277|Primary|5-Day Sum of Pain Intensity Difference (SPID5)|SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where “0” is no pain and “10” is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).|Day 1 to Day 5|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).||Units on a scale||Standard Deviation|Mean
103716|NCT00784238|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Millimeter (mm)||Standard Deviation|Mean
103717|NCT00784238|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Millimeter (mm)||Standard Deviation|Mean
103718|NCT00784238|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103719|NCT00784238|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103720|NCT00784238|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
103721|NCT00784238|Primary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103722|NCT00784238|Primary|Drug Attitude Inventory (DAI-10) Total Score at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103723|NCT00784238|Primary|Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103724|NCT00784238|Primary|Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103725|NCT00784238|Primary|Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103726|NCT00784238|Primary|Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103727|NCT00784238|Primary|Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103728|NCT00784238|Primary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103729|NCT00784238|Primary|Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Week 24|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
103730|NCT00784147|Secondary|Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS|The mean change in CD4+ T-cell count from the Baseline measurement at Week 24/End of Study was summarized at each scheduled time point by treatment group.|Week 24 / End of Study|||cell/mL||Standard Deviation|Mean
103731|NCT00784147|Secondary|Mean Change From Baseline in Viral Load (log10) at Week 24/EOS|The mean change in HIV-1 RNA (log10) from the Baseline measurement was analyzed at Week 24/End of Study using a generalized linear model at each scheduled study visit.|Week 24 / End of Study|||log10 copies/mL||Standard Deviation|Mean
103732|NCT00784147|Other Pre-specified|Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 0.5 log10 reduction from the Baseline measurement in HIV-1 RNA at Week 24 of the study.|Week 24|||percentage of patients|||Number
103733|NCT00784147|Other Pre-specified|Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 1.0 log10 reduction from Baseline in HIV-1 RNA.|Week 24|||percentage of patients|||Number
103734|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <400 Copies/mL at Week 24|This efficacy measure was assessed in the same manner as the primary efficacy analysis to determine the proportion of the total population achieving HIV-1 RNA levels <400 copies at Week 24 of the study.|Week 24|||percentage of patients|||Number
103736|NCT00784147|Primary|The Proportion of Patients Achieving Undetectable Viral Loads at Week 24.|"For the primary efficacy analysis, undetectable was defined as having HIV-1 RNA below the limit of assay detection at <50 copies/mL. The primary efficacy endpoint was analyzed using Fisher exact test. The primary analysis was performed using the ITT population and both the missing data equals treatment failure (MEF) and last observation carried forward (LOCF) methods. The more conservative MEF results are recorded here."|24 weeks|||percentage of participants|||Number
103737|NCT00784095|Primary|QUAL-E Completion Sub-scale|A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.|Baseline, 6 and 8 week follow up|||units on a scale||Standard Deviation|Mean
103738|NCT00784095|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.|Baseline, 6 and 8 week follow ups|||units on a scale||Standard Deviation|Mean
103739|NCT00784095|Secondary|Center for Epidemiology Studies - Depression Scale (CES-D)|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline, 6 and 8 week follow up|||units on a scale||Standard Deviation|Mean
103740|NCT00784095|Secondary|Functional Status ADL|Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.|Baseline, 6 and 8 week follow ups|||units on a scale||Standard Deviation|Mean
103741|NCT00784095|Primary|Quality of Life - Preparation|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.|Baseline, 6 and 8 week follow up|||units on a scale||Standard Deviation|Mean
103742|NCT00784030|Primary|Change in Urine cAMP Concentration and Urine Osmolality (UOsm)|Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours|pre- and post-water loading (2 hours)|Number of participants was deemed to be adequate for the purposes of this pilot study||fold change in cAMP/UOsm (umol/UOsm)||Standard Error|Mean
103743|NCT00783965|Primary|Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0||Baseline and 36 months|||participants|||Number
103744|NCT00783965|Primary|Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter||Baseline and 36 months|||participants|||Number
103745|NCT00783835|Secondary|Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12|It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening.|Screening (Week -2), 4 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103746|NCT00783835|Secondary|Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale|The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103747|NCT00783835|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).|Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103748|NCT00783835|Secondary|Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = Normal, not at all ill and a rating of 7 = Among the most extremely ill participants. Higher scores indicate worsening."|Screening (Week -2), 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103749|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103814|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103750|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 4|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103751|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103752|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 8|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103753|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4|Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 4|Intent to treat efficacy evaluation (ITTe) included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.||Unit on a scale||Standard Error|Mean
103754|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years||||||
103755|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years||||||
103756|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103757|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103758|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103759|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103815|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103760|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of participants||95% Confidence Interval|Number
103761|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of participants||95% Confidence Interval|Number
103762|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of participants||95% Confidence Interval|Number
103763|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years||||||
103764|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years||||||
103765|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103766|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103767|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103768|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103769|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103770|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years||||||
103771|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years||||||
103800|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103772|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103773|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103774|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103775|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103776|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103777|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years||||||
103778|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years||||||
103779|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103780|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103781|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103782|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103783|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103784|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years||||||
103785|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years||||||
103786|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103787|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103797|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103788|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103789|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103790|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization (TVR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103791|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|5 years||||||
103792|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|4 years||||||
103793|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103794|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103795|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103796|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103798|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|5 years||||||
103799|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|4 years||||||
103801|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103802|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103803|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103804|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103805|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|5 years||||||
103806|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|4 years||||||
103807|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103808|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103809|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103810|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103811|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103812|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|5 years||||||
103813|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|4 years||||||
103904|NCT00783705|Secondary|Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment|The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.||percentage change in number of lesions||Standard Deviation|Mean
103816|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103817|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103818|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103819|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|5 years||||||
103820|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|4 years||||||
103821|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103822|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103823|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103824|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103825|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103826|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|5 years||||||
103827|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|4 years||||||
103828|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103829|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103925|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl|Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).|6 weeks of treatment|||participants|||Number
103830|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103831|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103832|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103833|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants|||Number
103834|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants|||Number
103835|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants|||Number
103836|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 1123 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103837|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 758 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103848|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|greater than 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103838|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 days to 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103839|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|> 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103840|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103841|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103842|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103843|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103844|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 1123 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103845|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 758 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103846|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|>1 year (Very late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103847|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|31 days - 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103849|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103850|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years||||||
103851|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years||||||
103852|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103853|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103854|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103855|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103856|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103857|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|5 years||||||
103858|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|4 years||||||
103859|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103860|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||percentage of participants||95% Confidence Interval|Number
103861|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103862|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103863|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants||95% Confidence Interval|Number
103864|NCT00783796|Secondary|Distal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
103865|NCT00783796|Secondary|Proximal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
103866|NCT00783796|Secondary|In-segment Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
103867|NCT00783796|Secondary|In-stent Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage of Participants||95% Confidence Interval|Number
103868|NCT00783796|Secondary|Distal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
103869|NCT00783796|Secondary|Proximal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
103870|NCT00783796|Secondary|In-segment % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
103871|NCT00783796|Secondary|In-stent % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Percentage||Standard Deviation|Mean
103872|NCT00783796|Secondary|Distal Late Loss|Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeter||Standard Deviation|Mean
103873|NCT00783796|Secondary|Proximal Late Loss|Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeter||Standard Deviation|Mean
103874|NCT00783796|Secondary|In-segment Late Loss (LL)|In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.|240 Days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeters||Standard Deviation|Mean
103875|NCT00783796|Secondary|In-Stent Late Loss|In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).||Millimeters||Standard Deviation|Mean
103876|NCT00783796|Secondary|Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)|Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.|From the start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.||Percentage of Participants|||Number
103926|NCT00783263|Secondary|Number of Participants Who Reached the LDL-C Level of <70 mg/dl|Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|6 weeks of treatment|||participants|||Number
103877|NCT00783796|Secondary|Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)|Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.|From start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects||Percentage of Lesions|Participants||Number
103878|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).||Percentage of Participants|||Number
103879|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.||percentage of participants||95% Confidence Interval|Number
103880|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission."|Week 6 and Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
103881|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
103882|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Response|"Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response."|Baseline, Week 6 and Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
103883|NCT00783718|Secondary|Induction Phase: Percentage of Participants With Mucosal Healing at Week 6|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 6|Induction Study ITT Population||percentage of participants||95% Confidence Interval|Number
103884|NCT00783718|Secondary|Induction Phase: Percentage of Participants in Clinical Remission at Week 6|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study ITT Population||percentage of participants||95% Confidence Interval|Number
103953|NCT00783094|Secondary|Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement|Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.|Baseline, 12 weeks|Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.||nanogram/milliliter||Standard Deviation|Geometric Mean
103885|NCT00783718|Primary|Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.||percentage of participants||95% Confidence Interval|Number
103886|NCT00783718|Primary|Induction Phase: Percentage of Participants With a Clinical Response at Week 6|"Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical response."|Baseline and Week 6|Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.||percentage of participants||95% Confidence Interval|Number
103887|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
103888|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
103889|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||mmol/L||Inter-Quartile Range|Median
103890|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
103891|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||pg/mL||Inter-Quartile Range|Median
103892|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||pg/mL||Inter-Quartile Range|Median
103893|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
103894|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available||ng/mL||Inter-Quartile Range|Median
103895|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||umol/L||Inter-Quartile Range|Median
103896|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
103897|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
103898|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
103899|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||pg/mL||Inter-Quartile Range|Median
103900|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||pg/mL||Inter-Quartile Range|Median
103901|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available||ng/mL||Inter-Quartile Range|Median
103902|NCT00783705|Secondary|Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray||From baseline up to 6 months||||||
103903|NCT00783705|Secondary|Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia||From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.||percentage of Ki67 expression level||Standard Deviation|Mean
103956|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
103905|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.|"The definitions of responses are:~Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease"|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.||percentage of participants|||Number
103906|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.|"The definitions of responses are:~Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression."|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.||percentage of participants|||Number
103907|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission"|Assessed every 4 weeks from Week 6 to Week 50, and at Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
103908|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52|"Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.||percentage of participants||95% Confidence Interval|Number
103909|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 52|Maintenance Study ITT Population||percentage of participants||95% Confidence Interval|Number
103910|NCT00783692|Secondary|Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6|C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).|Baseline and Week 6|Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group.||mg/L||Full Range|Median
103911|NCT00783692|Primary|Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52|"Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.||percentage of participants||95% Confidence Interval|Number
103912|NCT00783692|Primary|Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|Induction Study ITT Population||percentage of participants||95% Confidence Interval|Number
103913|NCT00783692|Primary|Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.||percentage of participants||95% Confidence Interval|Number
103914|NCT00783614|Primary|Blood Markers of Inflammation, Endothelial Injury, and Thrombosis||changes from baseline to 6 months||||||
103915|NCT00783614|Primary|Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events|At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication|6 months|The number of participants with adverse events or reporting side effects||participants|||Number
103916|NCT00783432|Secondary|Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.|The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.|baseline, months 1,3,6,9 and 12/or early termination|Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.||Units on a scale||Standard Deviation|Least Squares Mean
103917|NCT00783432|Primary|Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.|Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.|baseline and 12 months/ET|||Participants|||Number
103918|NCT00783432|Primary|Number of Participants Reporting Adverse Events|An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.|12 months|Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.||Participants|||Number
103919|NCT00783302|Secondary|Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.|"The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.~This outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration."|Within 1 month, 6 months and 12 months post contrast administration.|||Number of Subjects|||Number
103920|NCT00783302|Primary|The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|||Percentage of Subjects||95% Confidence Interval|Number
103921|NCT00783302|Primary|The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|||Percentage of Subjects||95% Confidence Interval|Number
103922|NCT00783302|Primary|The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|||Percentage of Subjects||95% Confidence Interval|Number
103923|NCT00783302|Primary|The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|The subject follow-up period went from 1 month, 6 months and 12 months.||Percentage of Subjects||95% Confidence Interval|Number
103924|NCT00783263|Secondary|Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels|Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.|Baseline to 6 weeks|||percentage change||Standard Deviation|Mean
103927|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached Their Target LDL-C Level|Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.|6 weeks of treatment|||participants|||Number
103928|NCT00783263|Secondary|Number of Participants Who Reached Their Target LDL-C Level|Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.|6 weeks of treatment|||participants|||Number
103929|NCT00783263|Secondary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks|||percentage change||Standard Deviation|Mean
103930|NCT00783263|Primary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks|||percent change||Standard Deviation|Mean
103931|NCT00783224|Primary|Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks|The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.|Baseline to 2 weeks of treatment|||Units on a scale||Standard Error|Least Squares Mean
103932|NCT00783198|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
103933|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
103934|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
103935|NCT00783198|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.||score on a scale||Standard Error|Mean
103954|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||milliliters per second||Standard Error|Least Squares Mean
103955|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
103936|NCT00783198|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to Good Clinical Practice (GCP) issues.||score on a scale||Standard Error|Mean
103937|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint|Post residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||milliliter||Standard Deviation|Mean
103938|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||microgram/liter||Standard Deviation|Mean
103939|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 54-Week Endpoint||Baseline, 54-weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||beats per minute (bpm)||Standard Deviation|Mean
103940|NCT00783094|Secondary|Change From Baseline in Blood Pressure During at 54-Week Endpoint||Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||millimeters of mercury (mmHg)||Standard Deviation|Mean
103941|NCT00783094|Secondary|Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment|A listing of Adverse Events are reported in the Reported Adverse Event Section.|End of 12 weeks of double-blind through 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||participants|||Number
103942|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
103943|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
103944|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
103945|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 54 weeks|All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
103946|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
103947|NCT00783094|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.||units on a scale||Standard Deviation|Mean
103948|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 12 weeks|Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.||Micrograms per liter||Standard Deviation|Mean
103949|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint|Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.||milliliters||Standard Deviation|Mean
103950|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 12-Week Endpoint||Baseline, 12 Weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.||beats per minute||Standard Deviation|Mean
103951|NCT00783094|Secondary|Change From Baseline in Blood Pressure at 12-Week Endpoint||Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.||mmHg||Standard Deviation|Mean
103952|NCT00783094|Secondary|Number of Participants With Adverse Events During 12 Weeks of the Study|A listing of Adverse Events are reported in the Reported Adverse Event Section.|Baseline through 12 weeks|All randomized participants||participants|||Number
103957|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
103958|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
103959|NCT00783094|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.||units on a scale||Standard Error|Least Squares Mean
103960|NCT00782834|Primary|Response Rate|Response rate of nilotinib by RECIST criteria evaluated every 2 months for the first 6 months then every 3 months for the duration of treatment period.|1year|||Participants|||Number
103961|NCT00782834|Primary|Progression Free Survival Rate at 6 Months|Number of participants that demonstrate progression free survival at 6 months|6 months|||Participants|||Number
103962|NCT00782821|Secondary|Patient Allograft Survival at 12 Months|Patient's allograft was still functioning at 12 months post study enrollment|12 months|||participants|||Number
103963|NCT00782821|Secondary|Patient Survival at 12 Months|Patient was still alive 12 months post study enrollment.|12 months|||participants|||Number
103964|NCT00782821|Secondary|Acute Cellular Rejection by Banff '97 Criteria (Updated 2005)|"Acute cellular rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months|||participants|||Number
103965|NCT00782821|Secondary|Antibody-mediated Rejection by Banff '97 Criteria (Updated 2005)|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria. Rejection due, at least in part, to documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated); may coincide with categories 3, 4 and 5.~Grade I. ATN-like – C4d+, minimal inflammation Grade II. Capillary- margination and/or thromboses, C4d+ Grade III. Arterial – v3, C4d+"|6 months|||participants|||Number
103966|NCT00782821|Primary|Incidence of Acute Rejection (Banff ’97) or Antibody Mediated Rejection|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria.~Acute rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months|||participants|||Number
103967|NCT00782717|Secondary|Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).|BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.|From Day 7 to Day 90 (or Early Exit)|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).||Percentage of patients|||Number
103968|NCT00782717|Primary|Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery|Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).|3 Months|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).||Percentage of patients|||Number
103969|NCT00782639|Primary|Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit|Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|||milligrams per deciliter (mg/dL)|||Number
103970|NCT00782639|Secondary|Number of Participants Who Died From Acute Renal Failure|This outcome measure provides the total number of participants who died as a result of acute renal failure.|Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)|||Participants|||Number
103971|NCT00782639|Secondary|Number of Participants Requiring Dialysis|This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.|48 to 72 hours after injection of contrast media|||Participants|||Number
103972|NCT00782639|Secondary|The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)|This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|||Participants|||Number
103973|NCT00782639|Secondary|The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)|This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media|||Participants|||Number
103974|NCT00782639|Primary|The Number of Participants With Contrast-induced Nephropathy (CIN)|The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|48 to 72 hours After Injection of Contrast Media|||Participants|||Number
103975|NCT00782626|Primary|Overall Response|Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy.Description: Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy. Response for target lesions (up to5) is based on 3 dimensions with an elliptical model volume used: 0.5L*W*T; (L) tumor extent in plane perpendicular to the selected plane; (W) longest measurement of the tumor width; (T) transverse measurement perpendicular to the width. CR is disappearance all target and non-target lesions and no new lesions. PR is >/= 65% decrease in sum of the products (referent baseline). PD 40% or more increase in any target lesion (referent smallest product observed on therapy). SD is none of the above. PR and SD classification as long as absent new lesions and unequivocal progression for non-target lesions else PD.|Disease evaluations (MRI brain, including volumetric analysis) occurred at baseline, at the end of course 1, every 3 courses during treatment up to 12 courses and at early treatment discontinuation.|The analysis dataset is comprised of all evaluable patients. All treated patients were evaluable.||participants|||Number
103976|NCT00782509|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.||mmol/L||Standard Deviation|Mean
103977|NCT00782509|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.||percentage of participants|||Number
103978|NCT00782509|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Mean number of moderate COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||COPD exacerbations||Standard Error|Mean
103979|NCT00782509|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Mean number of COPD exacerbations requiring hospitalization per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||COPD exacerbations||Standard Error|Mean
103980|NCT00782509|Secondary|Number of COPD Exacerbations|Mean number of COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||COPD exacerbations||Standard Error|Mean
103981|NCT00782509|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol.Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval..|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
103982|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
104045|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 60|18 patients had chimerism drawn at Day 60||participants|||Number
103983|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank.~The measured values presented are actually the First Quartile and 95% confidence interval."|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
103984|NCT00782509|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS||Point on scale||Standard Error|Mean
103985|NCT00782509|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS||Point on scale||Standard Error|Mean
103986|NCT00782509|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS||Point on scale||Standard Error|Mean
103987|NCT00782509|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS||Point on scale||Standard Error|Mean
103988|NCT00782509|Secondary|Weekly Mean of Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each 24 hour period during week 48.|Week 48|FAS||Number of puffs||Standard Error|Mean
103989|NCT00782509|Secondary|Weekly Mean of Daily Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each night during week 48.|Week 48|FAS||Number of puffs||Standard Error|Mean
103990|NCT00782509|Secondary|Weekly Mean of Daily Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each day during week 48.|Week 48|FAS||Number of puffs||Standard Error|Mean
103991|NCT00782509|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS||L/min||Standard Error|Mean
103992|NCT00782509|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS||L/min||Standard Error|Mean
103993|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
103994|NCT00782509|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
103995|NCT00782509|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104046|NCT00782379|Secondary|Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)||Day 100|2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality||participants|||Number
104052|NCT00782340|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|||mmHg||Standard Deviation|Mean
103996|NCT00782509|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
103997|NCT00782509|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
103998|NCT00782509|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
103999|NCT00782509|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours aftertreatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
104000|NCT00782509|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
104001|NCT00782509|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
104002|NCT00782509|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
104003|NCT00782509|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
104004|NCT00782509|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
104053|NCT00782340|Secondary|Clinician-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days|||participants|||Number
104005|NCT00782509|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS||Liter||Standard Error|Mean
104006|NCT00782509|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
104007|NCT00782509|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
104008|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
104009|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104010|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
104011|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
104012|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
104013|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
104829|NCT00773786|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week|Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)|baseline and 1 week|||Liters||Standard Error|Mean
104014|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
104015|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104016|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
104017|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
104018|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
104019|NCT00782509|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
104020|NCT00782509|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
104021|NCT00782509|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
104022|NCT00782509|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
104047|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|18 patients had Day 30 chimerism drawn||participants|||Number
104023|NCT00782509|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
104024|NCT00782509|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
104025|NCT00782509|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
104026|NCT00782509|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
104027|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
104028|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104029|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
104030|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
104048|NCT00782379|Secondary|Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)|Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.|1 year|6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality.||participants|||Number
104031|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
104032|NCT00782509|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
104033|NCT00782509|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS||Liter||Standard Error|Mean
104034|NCT00782509|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.||Liter||Standard Error|Mean
104035|NCT00782496|Secondary|Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2|Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.|Over six month period|63 surveys were available for analysis.||percent of Level 2 participants|||Number
104036|NCT00782496|Primary|Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features||6 months|For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.||number of post-prandial tests per week||Standard Error|Mean
104037|NCT00782483|Primary|Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.|Three treatments up to one year, whichever is first|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.|||||
104038|NCT00782418|Primary|Change From Baseline in Insulin Concentration||Pre and Post glucose infusion|All subjects treated||μIU(insulin)/mL||Full Range|Least Squares Mean
104039|NCT00782418|Primary|Change From Baseline in C-peptide Concentration||Pre and Post glucose infusion|All subjects treated||ng/mL||Full Range|Least Squares Mean
104040|NCT00782418|Primary|Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose|"Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate.~Insulin Secretion Rate (ISR)/ Blood Glucose (BG)"|Steady-state of HGC: 90 – 120 minutes post dose; highest glucose infusion rate of GGI: 120 – 160 minutes post dose|All subjects treated||(ng/min) / (mg/dL)||Full Range|Geometric Mean
104041|NCT00782379|Secondary|Disease Free Survival at Day 100|Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.|Day 100|17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100||participants|||Number
104042|NCT00782379|Secondary|Disease Free Survival at 12 Months|Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.|12 months|14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year||participants|||Number
104043|NCT00782379|Secondary|Overall Survival at 12 Months|Overall survival, defined as a patient being alive after transplant, is without regard to disease status.|12 months|20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year||participants|||Number
104044|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|13 patients had chimerism drawn at Day 90||participants|||Number
104054|NCT00782340|Secondary|Patient-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days|||participants|||Number
104055|NCT00782340|Secondary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
104056|NCT00782340|Secondary|Change in Activities Involving Walking a Short Time (OHDAS Item 3)|OHDAS Item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
104057|NCT00782340|Secondary|Change in Activities Involving Standing a Short Time (OHDAS Item 1)|OHDAS Item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
104058|NCT00782340|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score|OHSA composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
104059|NCT00782340|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|OHDAS composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
104060|NCT00782340|Primary|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from randomization, negative numbers represent improvement from randomization in OHQ score."|7 days|Missing data are imputed using the last observation carried forward method.||units on a scale||Standard Deviation|Mean
104061|NCT00782288|Secondary|Clinically Significant Changes in the Microbiology of Sputum in Subjects|Count of clinically significant changes in sputum microbiology during the Treatment phase (Day 1 to Day 28) to include any new acquisition of B. cepacia or new acquisition of any multiple resistant organism.|28 days|There were no significant changes in the microbiology of sputum in any subjects over the course of treatment.||participants|||Number
104062|NCT00782288|Secondary|Clinically Significant Alterations in ECG Readings|Safety indices included an assessment for the number of clinically significant alterations in the subjects ECG readings from Day 1 to Day 28.|28 days|Count of clinically significant alterations in the ECG in all subjects during the Treatment Phase of the study.||participants|||Number
104063|NCT00782288|Secondary|Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression.|Rhinoprobe was used to collect nasal epithelial cells. The cells were collected pre and post-treatment and placed in Trizol for RNA isolation then used to measure the effect of digitoxin on gene expression. The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). The accession number for that data is GSE76347 (data available Dec 2018).|Day 0 and Day 28|The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). Results can be found under the accession number GSE76347. One subject's pair of specimens in the placebo group was not collected.||participants|||Number
104064|NCT00782288|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.|Median change in serum ESR (mm/hr) and IQR was calculated from Treatment Period (28 days).|Baseline and Day 28|All subjects had blood labs for ESR drawn on Visits 1,3,4 and 5. The changes in median ESR were calculated during the Treatment Period (28 days).||mm/hr||Inter-Quartile Range|Median
104065|NCT00782288|Secondary|Changes in C Reactive Protein (CRP) During Treatment.|Median changes in CRP and IQR were assessed from serum samples collected at Visits 1,3, 4 and 5.|Baseline and Day 28|All subjects had blood labs for CRP drawn on Visits 1,3,4 and 5. The changes in median CRP were calculated during the Treatment Period (28 days).||mg/dL||Inter-Quartile Range|Median
104066|NCT00782288|Primary|Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).|The change in log 10 neutrophil cell count from Day 28 minus Day 1 (during the treatment period) expressed as log (10^4 neutrophil/mL).|28 days (Day 28 minus Day 1)|The change in neutrophil cell count from Day 1 to Day 28 was performed using a Kruskal-Wallis equality of populations rank test. The cells counts are expressed as log 10 (neutrophil cell/mL).||log 10 (neutrophil cell/mL)||Inter-Quartile Range|Median
104067|NCT00782288|Primary|Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The neutrophil counts were measured in the induced sputum of participants in each group on study 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1- Day 42)|Neutrophil cell counts were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between the placebo and the two digitoxin dose levels.||log 10 (neutrophil cells/mL)||Inter-Quartile Range|Median
104068|NCT00782288|Primary|Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).|Change in Il-8 values are expressed as a change in log 10 Il-8 pg/mL from Day 28 minus Day 1.|28 days (Day 28 minus Day 1)|For change in Il-8 from Day 28 minus Day 1, a Kruskal-Wallis equality of populations rank was performed.||log10 (pg/mL)||Inter-Quartile Range|Median
104069|NCT00782288|Secondary|Change in WBC (White Blood Cell) Count by Group During Treatment Period|Safety indices included changes in FEV1 (lung function), changes in WBC, alterations in ECG and sputum microbiology. There were no significant alterations in the ECG in any subjects over the course of the study. There were no subjects who acquired multiple resistant changes in microbiology of sputum and no acquisition of B. cepacia in any subjects. Therefore, these data were not analyzed. The median changes in FEV1 and median changes in WBC, ESR and CRP are reported.|Baseline and Day 28|Safety indices included changes in WBC during treatment for each group.||K/cu mm||Inter-Quartile Range|Median
104070|NCT00782288|Secondary|Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R).|"CFQ-R is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms. Developed specifically for use in patients with a diagnosis of cystic fibrosis. There are 9 Quality of life domains: physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions and 3 symptom scales: weight, respiratory, and digestion.~Scaling of items is done via 5 distinct 4-point Likert scales. Scores for each domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. Based on clinician judgment of global clinical change, a moderate change was a standardized effect size of 0.50 units and an important change was a standardized effect size of 0.80 units evaluating pre- and post-treatment for CF exacerbation. Mean changes in CFQ-R Scores by Group were evaluated between Visit 6 and Visit 1, by Domain."|Baseline and Day 42|Mean change in CFQ-R scores from Visit 1 to Visit 6, by domain.||mean change of scores on a scale||Standard Deviation|Mean
104071|NCT00782288|Secondary|Safety Indices Including Change in FEV1 in Stable CF Patients.|Safety indices included changes in FEV1 (forced expiratory volume in 1 second), changes in WBC (white blood cell count), alterations in ECG and sputum microbiology. The median changes in FEV1 are reported.|Baseline and Day 28|Median changes in FEV1 in L by group for the 28 days of treatment.||liters||Inter-Quartile Range|Median
104072|NCT00782288|Secondary|Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.|Digitoxin serum levels were drawn on Days 1 (pre-dose), 7, 14, 21 and 42. The range of digitoxin levels for each visit is listed and the number of subjects who had that level are marked by group (placebo, low dose and high dose).|Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42|Subjects had serum digitoxin levels drawn at Day 1 (pre-dose) with no levels observed, as expected. Digitoxin was drawn on Day 7, 14, 21 and 42 to determine the number of subjects with a detectable level of digitoxin (ng/mL) in serum by group.||participants|||Number
104073|NCT00782288|Primary|Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The Il-8 measurements of sputum digitoxin levels for each group is shown for 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1 to Day 42)|Sputum was collected for Il-8 biomarkers on Days 1,14, 21, 28 during the treatment phase and at Day 42. Measures were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between placebo and the two doses.||log 10 (pg/mL)||Inter-Quartile Range|Median
104074|NCT00782210|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.||mmol/L||Standard Deviation|Mean
104075|NCT00782210|Secondary|Changes in Safety Parameters Related to Treatment|Occurrence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.||percentage of participants|||Number
104076|NCT00782210|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|||Number of COPD exacerbations||Standard Error|Mean
104077|NCT00782210|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD exacerbations||Standard Error|Mean
104078|NCT00782210|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication||Number of COPD exacerbations||Standard Error|Mean
104079|NCT00782210|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
104142|NCT00782184|Secondary|Percent Change From Baseline in Triglycerides||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104080|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
104081|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication||days||95% Confidence Interval|Mean
104082|NCT00782210|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS||Point on scale||Standard Error|Mean
104083|NCT00782210|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS||Point on scale||Standard Error|Mean
104084|NCT00782210|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS||Point on scale||Standard Error|Mean
104085|NCT00782210|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS||Point on scale||Standard Error|Mean
104086|NCT00782210|Secondary|Weekly Mean Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS||Number of puffs||Standard Error|Mean
104087|NCT00782210|Secondary|Weekly Mean Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS||Number of puffs||Standard Error|Mean
104088|NCT00782210|Secondary|Weekly Mean Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS||Number of puffs||Standard Error|Mean
104089|NCT00782210|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS||L/min||Standard Error|Mean
104090|NCT00782210|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS||L/min||Standard Error|Mean
104091|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
104092|NCT00782210|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
104093|NCT00782210|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104094|NCT00782210|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
104095|NCT00782210|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
104096|NCT00782210|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
104097|NCT00782210|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
104098|NCT00782210|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
104099|NCT00782210|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
104100|NCT00782210|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
104101|NCT00782210|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
104102|NCT00782210|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
104143|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104103|NCT00782210|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS||Liter||Standard Error|Mean
104104|NCT00782210|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
104105|NCT00782210|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
104106|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
104107|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104108|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
104109|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
104110|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
104111|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
104112|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
104113|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104114|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS||Liter||Standard Error|Mean
104115|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
104116|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
104117|NCT00782210|Secondary|Peak FEV1 (0-3h) Response At Day 1|"Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.~Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by- visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect."|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS||Liter||Standard Error|Mean
104118|NCT00782210|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS||Liter||Standard Error|Mean
104119|NCT00782210|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS||Liter||Standard Error|Mean
104120|NCT00782210|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS||Liter||Standard Error|Mean
104144|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <100 mg/dL|Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.||participants|||Number
104121|NCT00782210|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS||Liter||Standard Error|Mean
104122|NCT00782210|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS||Liter||Standard Error|Mean
104123|NCT00782210|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS||Liter||Standard Error|Mean
104124|NCT00782210|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS||Liter||Standard Error|Mean
104125|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS||Liter||Standard Error|Mean
104126|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS||Liter||Standard Error|Mean
104127|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS||Liter||Standard Error|Mean
104128|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS||Liter||Standard Error|Mean
104145|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <77 mg/dL|Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.||participants|||Number
104129|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|FAS||Liter||Standard Error|Mean
104130|NCT00782210|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)||Liter||Standard Error|Mean
104131|NCT00782210|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS||Liter||Standard Error|Mean
104132|NCT00782210|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.||Liter||Standard Error|Mean
104133|NCT00782184|Secondary|Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104134|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B/A-1 Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104135|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein A-1||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104136|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104137|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104138|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104139|NCT00782184|Secondary|Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104140|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104141|NCT00782184|Secondary|Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104146|NCT00782184|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL)-C||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.||percent change from baseline||95% Confidence Interval|Least Squares Mean
104147|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goals of <70 mg/dL|Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.||participants|||Number
104148|NCT00781963|Primary|Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 – 21. A total score > 8 indicates poor sleep quality.|Six months after baseline assessment|||units on a scale||Standard Deviation|Mean
104149|NCT00781963|Primary|Sleep Efficiency|Calculated from 7-day sleep diary|Six months after baseline assessment||||||
104150|NCT00781950|Secondary|Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.||1 year|||mmHg||Standard Error|Mean
104151|NCT00781950|Primary|Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions||1 year|||participants|||Number
104152|NCT00781937|Secondary|Binge Eating Scale Scores by Week and Severity|Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)|Week 0, week 50 and week 57|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||scores on a scale||Standard Deviation|Mean
104153|NCT00781937|Secondary|Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)|Number of subjects using concomitant medications at Week 0 and Week 56, respectively|Week 0 and week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||Subjects|||Number
104154|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)|Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage point||Standard Error|Least Squares Mean
104155|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||pmol/L||Standard Error|Least Squares Mean
104156|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
104157|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)|Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||proportion||Standard Error|Least Squares Mean
104158|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)|Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percent change||Standard Error|Least Squares Mean
104159|NCT00781937|Secondary|Change From Baseline in Body Mass Index (BMI)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||kg/m^2||Standard Error|Least Squares Mean
104160|NCT00781937|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||cm||Standard Error|Least Squares Mean
104161|NCT00781937|Secondary|Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56|Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.|Week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104162|NCT00781937|Secondary|Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||nmol/L||Standard Error|Least Squares Mean
104163|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Total Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
104164|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
104165|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Triglycerides|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmol/L||Standard Error|Least Squares Mean
104166|NCT00781937|Secondary|Change From Baseline in Pulse||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||beats/minute||Standard Error|Least Squares Mean
104167|NCT00781937|Secondary|Change From Baseline in Blood Pressure||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||mmHg||Standard Error|Least Squares Mean
104168|NCT00781937|Secondary|Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 68|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||kg||Standard Error|Least Squares Mean
104169|NCT00781937|Secondary|Change From Baseline in Fasting Weight|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||kg||Standard Error|Least Squares Mean
104170|NCT00781937|Secondary|Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104171|NCT00781937|Secondary|Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104172|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104173|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104174|NCT00781937|Secondary|Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104175|NCT00781937|Primary|Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104176|NCT00781937|Primary|Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0|Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage of subjects|||Number
104177|NCT00781937|Primary|Mean Percentage Change in Fasting Body Weight From Baseline|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)||percentage||Standard Error|Least Squares Mean
104178|NCT00781859|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
104773|NCT00774397|Secondary|Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure|Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24)||mmHg||Standard Deviation|Mean
104179|NCT00781859|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.|The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.|Day 28|Intention-To-Treat (ITT), Last Observation Carried forward (LOCF)||percentage of participants|||Number
104180|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 2|A total of 57 participants completed the month 2 visit. The 15 participants lost to follow-up were treated as smokers for the purposes of data analysis.||participants|||Number
104181|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 1|A total of 60 participants completed the month 1 visit. The 12 participants lost to follow-up were treated as smokers for the purposes of data analysis.||participants|||Number
104182|NCT00781599|Secondary|Cotinine Verified 7 Day Point Prevalence Smoking Abstinence|Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.|Month 3|A total of 61 participants completed the final month 3 visit. The 11 participants lost to follow-up were treated as smokers for the purposes of data analysis.||participants|||Number
104183|NCT00781599|Primary|Percent Compliance With Chantix|Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.|Months 1, 2, 3|Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers.||Percentage of Participants||Standard Deviation|Mean
104184|NCT00781508|Secondary|The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.|A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.|Measured 1 hr after oral administration of sildenafil 50 mg|||meters||Standard Deviation|Mean
104185|NCT00781508|Primary|Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil|Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e|Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil|All patients (10) that completed the protocol were analyzed.||E/e' ratio||Standard Deviation|Mean
104186|NCT00781456|Secondary|Mean Number of Days of Bleeding or Spotting|Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.|91-day treatment period|Safety population with available data||days||Standard Deviation|Mean
104187|NCT00781456|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.~The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.~Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.~A serious adverse event (SAE) is one that met any one of the following criteria:~Fatal or life threatening~Requires or prolongs in patient hospitalization~Results in persistent or significant disability/incapacity~Congenital anomaly / birth defect~Important medical event."|Up to 15 weeks|Safety population, consisting of all participants who received at least one dose of study drug.||participants|||Number
104188|NCT00781456|Secondary|Change From Baseline in Headache Impact Test|"The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.~HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.~There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated."|Baseline and Week 15|Analysis was not performed due to an error in the administration of the test.|||||
104189|NCT00781456|Secondary|Change From Baseline in Migraine Disability Assessment|"The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.~The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).~The MIDAS score is classified into four grades of severity:~0 to 5: MIDAS Grade I, Little or no disability~6 to 10: MIDAS Grade II, Mild disability~11 to 20: MIDAS Grade III, Moderate disability~21+: MIDAS Grade IV, Severe disability"|Baseline and Week 15|Intent-to-treat population with available data.||units on a scale||Standard Deviation|Mean
104190|NCT00781456|Secondary|Percentage of Participants Who Required Rescue Medications During the Study Period|Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.|Baseline, Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.||percentage of participants|||Number
104201|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time frame included overall study period (first dose to end of study).||Number of participants with event|||Number
104191|NCT00781456|Secondary|Change From Baseline in Average Migraine Severity|"Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.~Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity."|Baseline and Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.||units on a scale||Standard Error|Least Squares Mean
104192|NCT00781456|Secondary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months|The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.|Baseline, Month1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time point.||percentage of participants|||Number
104193|NCT00781456|Primary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period|The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.|Baseline (25-35 days before Day 1) and Days 1-91|Intent-to-treat population||percentage of participants|||Number
104194|NCT00781391|Secondary|Adjudicated Bleeding Events|"Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.~Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements."|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|Safety-analysis set, on-treatment period||number of participants with event|||Number
104195|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality|Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.||number of participants with event|||Number
104196|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding|Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.||number of participants with event|||Number
104197|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality|Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit..||number of participants with event|||Number
104198|NCT00781391|Primary|Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).|Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit.||number of participants with event|||Number
104199|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (per Protocol) Analysis set; which included all randomized subjects who received 1 or more dose of study drug for the overall study period (first dose to end of study) and did not have any major protocol violations. The time period included from the reference date (initial dose of study drug date) to the common study end date (CSED) Visit.||number of participants with event|||Number
104200|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (Per Protocol) Analysis set; which included all randomized subjects who received at least 1 dose of randomized study drug and did not have any major protocol violations. The time period included the time the subject was taking study drug and up to 3 days after their last dose (On Treatment Period).||number of participants with event|||Number
104322|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Positive Score|To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
104202|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time period included the subject was taking study drug and up to 3 days after their last dose (On-Treatment ).||number of participants with event|||Number
104203|NCT00781365|Primary|Mean Diastolic Blood Pressure|Mean diastolic blood pressure at baseline and 3 time points|Baseline, 6 months, 12 months, 18 months|||mm Hg||95% Confidence Interval|Mean
104204|NCT00781365|Primary|Mean Systolic Blood Pressure|Systolic blood pressure at baseline and 3 time points|Baseline, 6 months, 12 months, 18 months|||mmHg||95% Confidence Interval|Mean
104205|NCT00781365|Primary|Blood Pressure Control|Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)|Baseline, 6 months, 12 months, 18 months|||percentage of participants||95% Confidence Interval|Number
104206|NCT00781326|Primary|Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]|Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression. We reports scores at end of Phase I for subjects completing the phase.|End of Phase I (at 24 weeks)|||units on a scale||Standard Deviation|Mean
104207|NCT00781274|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
104208|NCT00781079|Secondary|Quality of Life Interview, Brief Version|Subjective ratings of overall quality of life and the quality of social relationships, daily life, and family interactions was assessed using a combination of selected scales from the Quality of Life Instrument-Brief Version (QOLI), which been used extensively with a wide range of populations including those who are homeless, have a dual diagnosis, and are ethnic minorities. Because of low internal consistencies of subscales in our sample, a factor analysis was conducted which indicated that a larger scale that included the items from the overall quality of life, social relationships, daily life, and family interactions scales would be more reliable.|immediately before the intervention (BL), and 12 months post intervention (Post).||||||
104209|NCT00781079|Secondary|Illness Management and Recovery Scale: Client Self-Rating||12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).||||||
104210|NCT00781079|Secondary|Recovery Self-Assessment: Person in Recovery Version|Perceptions of the recovery orientation of the program were assessed with the Recovery Self-Assessment (RSA), a 36 item survey that assesses domains of recovery-orientated practice (e.g., focus on life goals, involvement of patients in their own care). The RSA has high internal consistency and is thought to represent a more recovery-oriented or recovery-supportive environment.|immediately before the intervention (BL), and 12 months post intervention (Post)||||||
104211|NCT00781079|Secondary|Patient Activation Measure|The mental health version of the Patient Activation Measure (PAM) is a single 13-item scale designed to assess patient’s knowledge, skill, and confidence in health self-management. Respondents endorse items (e.g., “I know what each of my prescribed medications do”) on a scale from 1 (“disagree strongly”) to 4 (“agree strongly”). Raw scores are converted using the established methodology for the PAM to an activation score from 0 (lowest)-100 (highest). Identifying levels of activation is based on whether an activation score falls within a previously determined range of scores. Level 1, the lowest level of activation, includes activation scores of 47 or lower; Level 2 includes scores of 47.1 to 55.1; Level 3 includes scores of 55.2 to 67.0; and Level 4 (the highest activation level) includes scores of 67.1 or above. This version has similar psychometric properties as the original 13-item PAM and correlates with related constructs in other samples of people with SMI.|immediately before the intervention (BL), and 12 months post intervention (Post).|||units on a scale||Standard Deviation|Mean
104212|NCT00781079|Secondary|Mental Health Recovery Measure (MHRM)|The Mental Health Recovery Measure (MHRM) is a 30-item, 5-point behaviorally-anchored self-report measure based upon recovery experiences of persons with psychiatric disabilities. The MHRM total score has good validity, correlating strongly with the Empowerment Scale and Community Living Skills Scales, yet assessing unique aspects of recovery.|immediately before the intervention (BL), and 12 months post intervention (Post).||||||
104213|NCT00781079|Primary|BASIS-R|The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96).|immediately before the intervention (BL), and 12 months post intervention (Post).|||units on a scale||Standard Deviation|Mean
104214|NCT00780910|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
104215|NCT00780741|Secondary|Proportion of Participants With Office Probing Success 6 Months After Randomization|The proportion of immediate office group participants whose office probing was successful when assessed 6 months after randomization. Office probing success was defined as absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) 6 months after randomization and no reoperation.|Randomization to 6 months|Participants randomized to immediate office probing who underwent office probing.||proportion with treatment success||95% Confidence Interval|Number
104216|NCT00780741|Secondary|Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon unmasked examination 6 months after randomization. Participants who were operated before the 6-month visit were considered treatment failures.|Randomization to 6 months|All participants who had unilateral nasolacrimal duct obstruction at baseline, who were randomized to the deferred facility probing group, and who completed the 6-month visit (timed from randomization). The analysis followed the intent to treat principle.||proportion of participants||95% Confidence Interval|Number
104217|NCT00780741|Secondary|Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age|Months of NLDO symptoms between randomization and 18 months of age. When resolution of NLDO occurred without surgery, the time of resolution was estimated as the midpoint between randomization and the first time point at which symptoms/signs were reported as absent (i.e. 3-month phone call, 6-month visit, or 18 months of age visit) without a subsequent report of symptoms/signs. For patients who underwent successful surgery, months of symptoms was estimated as months between randomization and the surgery. Patients who had clinical signs present at the 18 month of age visit were considered to have had symptoms present since randomization.|Randomization to 18 months of age.|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.||months of symptoms||Full Range|Mean
104218|NCT00780741|Primary|Cost of Treatment|Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.|Randomization to 18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.||US dollars||Full Range|Mean
104219|NCT00780741|Primary|Proportion of Participants With Treatment Success|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.|18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the primary outcome visit at 18 months of age were analyzed. The analysis followed the intent-to-treat principle.||proportion of participants|||Number
104220|NCT00780676|Primary|Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)|Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.|Tumor status assessed every 8 weeks during therapy, up to 6 months|Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to either group, and only treated participants (30) included in analysis.||Percentage of Participants|||Number
104221|NCT00780572|Primary|Time to Intervention Once an ADE Alert Has Fired in CPRS||From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.|||hours to intervention||Inter-Quartile Range|Median
104222|NCT00780455|Secondary|Quality of Life Assessed by Use of Self-questionnaire (SEP-59)|SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104223|NCT00780455|Secondary|Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)|FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104224|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits|"Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104236|NCT00780338|Primary|Prevention Capacity-Assets Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the Developmental Assets model. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid (1 year), post (2 years)|Despite drop outs, all the data was used.||percentage of the highest possible score||Standard Deviation|Mean
104225|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit|Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104226|NCT00780455|Secondary|Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit|The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104227|NCT00780455|Secondary|Covered Distance Gain Between MR2 Visit and MR3 Visit|"Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104228|NCT00780455|Primary|Rhythm Change During 6 Minutes Walking Test||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104229|NCT00780455|Primary|Distance of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104230|NCT00780455|Primary|Time of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104231|NCT00780455|Primary|Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.|||||
104232|NCT00780416|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up|||percentage of subjects achieving SVR||95% Confidence Interval|Number
104233|NCT00780403|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).||participants|||Number
104234|NCT00780338|Secondary|Prevention Performance - Total Score (Percent Change)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. Percent change was calculated from Pre to Mid, Mid to Post, PRE to POST.||percent change||Full Range|Mean
104235|NCT00780338|Secondary|Prevention Capacity - Assets Efficacy (User vs Non-user Analyses)|"The Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing assets activities. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"||percentage of the highest possible score||Standard Error|Least Squares Mean
104259|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104237|NCT00780338|Secondary|Prevention Capacity - Assets Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)|||percentage of the highest possible score||Standard Error|Least Squares Mean
104238|NCT00780338|Primary|Prevention Capacity - ASSETS Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat||percentage of the highest possible score||Standard Error|Least Squares Mean
104239|NCT00780338|Primary|Prevention Capacity - ASSETS GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat||percentage of the highest possible score||Standard Error|Least Squares Mean
104240|NCT00780338|Secondary|Prevention Capacity - ASSETS GTO BEHAVIORS (User vs Non-user Analyses)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)|||percentage of the highest possible score||Standard Error|Least Squares Mean
104241|NCT00780338|Secondary|Prevention Capacity - GTO Efficacy (User vs Non-user Analyses)|"The GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"||percentage of the highest possible score||Standard Error|Least Squares Mean
104242|NCT00780338|Secondary|Prevention Capacity - GTO Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in GTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)|||percentage of the highest possible score||Standard Error|Least Squares Mean
104243|NCT00780338|Primary|Prevention Capacity - GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat||percentage of the highest possible score||Standard Error|Least Squares Mean
104244|NCT00780338|Secondary|Prevention Performance - Total Score (Descriptive Means)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. These means are presented at the timepoints in which they were collected.||units on a scale|Participants|Full Range|Mean
104245|NCT00780338|Primary|Prevention Capacity-GTO Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid-point (1 year), posttest (2 years)|Despite drop outs, all the data was used.||percentage of the highest possible score||Standard Deviation|Mean
104246|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|24 months after surgery|||Percentage of implants|Participants||Number
104247|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|12 months after surgery|||Percentage of implants|Participants||Number
104248|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|6 months after surgery|||Percentage of implants|Participants||Number
104249|NCT00779246|Secondary|Vancomycin Resistant Enterococcal Infection or Colonization||During ICU stay||||||
104250|NCT00779246|Secondary|Central Line Associated Bloodstream Infection||During ICU stay||||||
104251|NCT00779246|Primary|Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection|Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).|During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.||participants|||Number
104252|NCT00779857|Primary|Percent of Patients With Complete Occlusion of the Left Atrial Appendage.|The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.|3 Months Post Procedure|The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.||percentage of subjects||95% Confidence Interval|Number
104253|NCT00779857|Primary|Rate of Device Related Serious Adverse Events|The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.|Discharge/30 days Post Procedure|The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.||Number of participants||95% Confidence Interval|Number
104254|NCT00779779|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Throughout the study period (Day 0 to Month 3 or 4)|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
104255|NCT00779779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
104256|NCT00779779|Secondary|Number of Subjects Reporting Each Type of Solicited General Symptoms|Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.|During the 8-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
104257|NCT00779779|Primary|"Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea"|"Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.~Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.~Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day."|During the 8-day solicited follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
104258|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104313|NCT00779558|Secondary|Cardiac ICU Length of Stay||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||days||Standard Deviation|Mean
104314|NCT00779558|Secondary|Days to Extubation||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||days||Standard Deviation|Mean
104260|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104261|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth congenital anomaly, Lost to follow up, Molar pregnancy and Pregnancy ongoing.~For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA)."|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104262|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104263|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104264|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104265|NCT00779766|Secondary|Number (%) of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104266|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104267|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104268|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104269|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104270|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104271|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104272|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104273|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104274|NCT00779766|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104275|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity"|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104276|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104277|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = prevented normal activity Grade 3 urticaria = distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104278|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling = swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
104279|NCT00779766|Secondary|Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status|"Titers were expressed as geometric mean titers calculated on all subjects HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at Months 0, 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72.~HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at Month 0, 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72..~Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above the assay cut-off value prior to vaccination."|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
104315|NCT00779558|Secondary|Total PRBCs Transfused||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||mL/kg||Standard Deviation|Mean
104280|NCT00779766|Secondary|Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL and 18 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subjects|||Number
104281|NCT00779766|Secondary|Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.||Subjects|||Number
104282|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104283|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104284|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection|CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104285|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection|"CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.~DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104286|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104316|NCT00779558|Primary|Thrombosis|Echocardiographic evidence of thrombosis while on study drug|While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days|||participants|||Number
104352|NCT00778999|Primary|Total Number of Oocytes|The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response|12 weeks|Intent-to-treat, defined as all randomized subjects who received recombinant follicle stimulating hormone||Number of oocytes||Standard Deviation|Mean
104287|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~US)."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104288|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104289|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104290|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104291|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18|"Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months.~Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA).~Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104292|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18|"Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months.~Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104293|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18|"HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered.~DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)~Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104317|NCT00779506|Secondary|Global Assessment of Functioning (GAF) Score|To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
104318|NCT00779506|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
104294|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18|"CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.~Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at Months 0 and 6 and seronegative at Month 0 or on subjects DNA- at Months 0 and 6, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.||Subjects|||Number
104295|NCT00779701|Primary|Time to Achieve Glycemic Control||Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.|||Minutes||Standard Deviation|Mean
104296|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline..|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
104297|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
104298|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
104299|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
104319|NCT00779506|Secondary|Clinical Global Impression (CGI) Score|The Clinical Global Impression – Severity (CGI-S) and – illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient’s current clinical state. The CGI-I is scored to rate the patient’s change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
104320|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score|To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
104300|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
104301|NCT00779675|Secondary|Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase with at least one PASI evaluation during the extended treatment phase.||Participants|||Number
104302|NCT00779675|Secondary|Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at each time point.||Participants|||Number
104303|NCT00779675|Secondary|Change From Baseline in Mean Dermatology Life Quality Index (DLQI)|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Baseline, Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at baseline and at each time point.||Score on a Scale||Standard Error|Mean
104304|NCT00779675|Secondary|Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase|PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase and had a PASI-75 response at Week 50 with at least one PASI evaluation during the extended treatment phase.||Participants|||Number
104305|NCT00779675|Secondary|Change From Baseline in Mean PASI Score|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.|Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98|The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 98.||Score on a Scale||95% Confidence Interval|Mean
104321|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Score|To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
104353|NCT00778921|Secondary|Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)||12 weeks||||||
104306|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively.|Week 98|The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase.||Participants|||Number
104307|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period|Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline.|Week 98|The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase.||Participants|||Number
104308|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline.|Week 50|The population includes all participants that achieved a PASI-50 response at treatment Week 14.||Participants|||Number
104309|NCT00779675|Secondary|Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline.|Week 50|The population consists of all participants that achieved PASI-75 response by treatment Week 14.||Participants|||Number
104310|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline.|Week 50|The population consists of all participants that achieved a PASI-90 response at treatment Week 14.||Participants|||Number
104311|NCT00779675|Primary|Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.||Participants|||Number
104312|NCT00779558|Secondary|Need for Antibiotics||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)|||participants|||Number
104323|NCT00779506|Primary|The Change in Positive and Negative Syndrome Scale(PANSS)Total Score|"PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 – 210.~Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method"|From baseline to Day 57|The MITT set was used for primary analyses (89) participants||score on a scale||Standard Deviation|Mean
104324|NCT00779311|Secondary|Determination of Quality of Life (QoL) as Indicated by Patient Care Monitor (PCM) Data Among Patients on This Regimen|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The frequency of patient reported severe (rated as >=7) symptoms reported from the set of symptoms assessed by the PCM.|The PCM questionnaire was administered on day 1 of each cycle (approximately every 2 weeks) during study treatment.|The number of patients out of the total sample of 8 patients who reported severe (rated as >=7) symptoms as assessed by the PCM. Symptoms with 0 patients reporting severe symptoms have been omitted.||Participants|||Number
104325|NCT00779311|Secondary|Determination of Progression Free Survival (PFS) Among Patients on This Regimen|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first.|||Months||95% Confidence Interval|Median
104326|NCT00779311|Primary|Determination of the Maximum Tolerated Dose (MTD) of Sorafenib When Given in Combination With mFOLFOX6 and Bevacizumab|The MTD of sorafenib was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first 2 cycles of treatment (i.e., the first 4 weeks of treatment since cycle length is 2 weeks)|3 patients (pts) were enrolled at DL 1 with 1/3 experiencing DLT, so 3 additional pts were enrolled at DL 1. 2 of those additional pts were not evaluable for DLT assessment and were replaced. 2 more pts were enrolled for a total of 8 pts, and 1 of these pts experienced a DLT. All of the 8 pts enrolled received sorafenib at DL 1.||mg every other day|||Number
104327|NCT00779285|Primary|Cardiac Events|A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).|Every 4 weeks during 6 cycles.|||Cardiac Events|||Number
104328|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Theophylline Co-administered With Quinine, Study Day 12.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours post-dose on Day 12|||msec|||Number
104329|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Quinine Study Day 11.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours after the morning dose on Day 11|||msec|||Number
104330|NCT00779259|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).||ug-hr/mL||Standard Deviation|Mean
104331|NCT00779259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).||ug-hr/mL||Standard Deviation|Mean
104332|NCT00779259|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).||ug/mL||Standard Deviation|Mean
104354|NCT00778921|Secondary|Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group||8 weeks|Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF)||Participants|||Number
104355|NCT00778921|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study||Baseline and Week 8|full analysis set||mm Hg||Standard Error|Least Squares Mean
104333|NCT00779155|Primary|"Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects on State."|The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.|Baseline and 8 weeks|Analysis was by intention to treat and all enrolled subjects completed the entire protocol.||scores on a scale||Standard Deviation|Mean
104334|NCT00779142|Secondary|Secondary Would be Significant Clinical Improvement (Judged at the Slit Lamp Exam Using a 90D Lens) in Macular Edema at the End of One Month After the Last Intraocular Injection.||1 month||||||
104335|NCT00779142|Secondary|Secondary Would be Increase in Visual Acutiy (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection.||1 month||||||
104336|NCT00779142|Primary|Primary Would be 30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection||4 weeks|||participants|||Number
104337|NCT00779116|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).||Participants|||Number
104338|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|End of Study treatment (Hour 72)|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
104339|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 48|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
104340|NCT00779038|Secondary|Number of Participants With Physician Global Assessment of Method of Pain Control|"The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
104341|NCT00779038|Secondary|Number of Participants With Nurse Global Assessment of Method of Pain Control|"The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
104342|NCT00779038|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: “Overall, would you rate this method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
104343|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24|Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 24|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.|||||
104344|NCT00779025|Secondary|Number of Sensations Experienced by Female Subjects - Overall|Number of sensations experienced by female subjects, based on two applications of the product for each subject.|1 Week|Intention to Treat||Sensations|Participants||Number
104345|NCT00779025|Secondary|Number of Sensations Experienced by Male Subjects - Overall|Number of sensations experienced by male subjects, based on two applications of the investigational product.|1 Week|||Sensations|Participants||Number
104346|NCT00779025|Primary|Number of Participants Showing Change From Baseline in Irritation Scores|Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions|1 week|Analysis was per Intention to Treat (ITT)||Participants|||Number
104347|NCT00778999|Secondary|Number of Good Quality Embryos|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
104348|NCT00778999|Secondary|Number of Fertilized (2PN) Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
104349|NCT00778999|Secondary|Number of Follicles on Day of hCG|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
104350|NCT00778999|Secondary|Number of Follicles on Stimulation Day 8|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
104351|NCT00778999|Secondary|Number of Mature Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks||||||
104356|NCT00778921|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study||Baseline and Week 8|full analysis set||mm Hg||Standard Error|Least Squares Mean
104357|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104358|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104359|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104360|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104361|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|"Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104362|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|"Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
104363|NCT00778895|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
104364|NCT00778895|Secondary|Seroconversion Factor for HI Antibodies|"The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
104365|NCT00778895|Secondary|Number of Subjects Seroprotected Against HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
104366|NCT00778895|Secondary|Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
104367|NCT00778895|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
104368|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104369|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104370|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104371|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104372|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.||subjects|||Number
104373|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
104395|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population|Baseline was defined as the value obtained at screening or value obtained on Day 1 before treatment. Diastolic and systolic blood pressure was measured in millimeters of mercury (mm Hg). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|||mm Hg||Standard Deviation|Mean
104374|NCT00778895|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.||subjects|||Number
104375|NCT00778869|Primary|Number of Genes Which Were Differentially Expressed|Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.|14 weeks|||Number of genes|||Number
104376|NCT00778830|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|Safety population consisted of all the enrolled subjects who received at least one dose of study treatment.||Subjects|||Number
104377|NCT00778830|Secondary|Overall Survival (OS) Time|OS time was defined as the time from first administration of study drug until date of death, assessed up to 5 years. OS time was censored if the subject was found to be alive on the last date of the assessment.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.||months||95% Confidence Interval|Median
104378|NCT00778830|Secondary|Progression-Free Survival (PFS) Time|PFS time was defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 90 days of the last tumor assessment or first study drug dose whichever occurred.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.||months||95% Confidence Interval|Median
104379|NCT00778830|Primary|Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)|Response rate was defined as the percentage of subjects with BORR (confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012)|Intention-to-treat (ITT) population consisted of all the enrolled subjects who received at least one dose of study treatment.||Percentage of subjects|||Number
104380|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks|Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount).|48 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
104381|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks|Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount).|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
104382|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks|Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount).|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
104383|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks|Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount).|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||participants|||Number
104384|NCT00778817|Secondary|Response at 48 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|48 weeks|||percentage of participants|||Number
104513|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 12 weeks of treatment|Intent to treat population||Units on a scale||95% Confidence Interval|Least Squares Mean
104385|NCT00778817|Secondary|Response at 18 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|18 weeks|||percentage of participants|||Number
104386|NCT00778817|Secondary|Response at 12 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|12 weeks|||percentage of participants|||Number
104387|NCT00778817|Secondary|Response at 6 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|6 weeks|||percentage of participants|||Number
104388|NCT00778817|Secondary|Best Response Rates|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|Up to 6 months|||percentage of participants|||Number
104389|NCT00778817|Primary|Progression-free Survival Rate at 18 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||percentage of participants|||Number
104390|NCT00778817|Primary|Progression-free Survival Rate at 12 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||percentage of participants|||Number
104391|NCT00778817|Primary|Progression-free Survival Rate at 6 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.||percentage of participants|||Number
104392|NCT00778648|Secondary|Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs||Baseline, months 2,4,6,8.||||||
104393|NCT00778648|Primary|Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.||within 6 months (after 2 months run-in period)|||Number of days||95% Confidence Interval|Mean
104394|NCT00778622|Other Pre-specified|Number of Participants Who Had a Normal Electrocardiogram (ECG) at Baseline and an ECG at Week 16 (or Termination Visit) Which Was Considered to be Abnormal With Clinical Significance - Safety Population|Baseline was defined as ECG obtained at the screening visit. A judgment of clinical significance was at the discretion of the investigator. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|number of participants with a normal ECG at baseline for normal weight, overweight, and obese arms were 71, 62, 65, respectively.||participants|||Number
104529|NCT00776984|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
104396|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population|Baseline was defined as ECG obtained at the screening visit. ECG was 12-lead. Heart rate (HR) was measured in beats per minute (beats/min). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Safety population included 125, 122, 124 participants in each arm, respectively. Participants missing from analysis for change at Week 16 for Heart Rate were 17, 18, 20 participants in the normal, overweight, obese arms, respectively.||beats/min||Standard Deviation|Mean
104397|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population|Urinalysis included pH and specific gravity. Baseline defined as values obtained at screening visit. Clinically significant: outside the reference range (low/high)and judged to be significant by the investigator: Specific gravity 1.003 - 1.035; ph 5 - 8. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|||participants|||Number
104398|NCT00778622|Other Pre-specified|Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population|Baseline defined as value obtained either in screening visit or last value obtained before glucophage XR treatment given on Day 1. Serum chemistries evaluating kidney or liver function: blood urea nitrogen(BUN), serum creatinine (SCr), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin (BR), uric acid (UA). Abnormal increase in kidney and liver function tests defined as 1.25 - less than, equal to (<=)2.6 times (x) upper limit of normal (ULN)in ALT, AST, total BR, UA; abnormal increase defined as 1.25 to <= 5.1 x ULN in BUN. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Number of participants (normal, overweight, obese, respectively) who were missing values and were not included in the Week 16 analysis for the following serum chemistry tests: ALT = 14, 11, 13; AST = 14, 11, 13; total BR = 14, 11, 13; creatinine = 14, 12, 13; BUN = 14, 12, 13; UA = 14, 12, 13.||participants|||Number
104399|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population|Hematology profile = hematocrit, hemoglobin, red blood cell count (RBC), white blood cell count(WBC), lymphocytes, monocytes, basophils, eosinophils, neutrophils, platelet count. Baseline: value obtained at screening or last value obtained before treatment. LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; RBC (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; WBC (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Week 16|Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.||participants|||Number
104400|NCT00778622|Other Pre-specified|Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population|Day 1 was first day of treatment. Lactic acidosis defined as elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and increased lactate/pyruvate ratio. Hypoglycemia (low levels of blood glucose) was reported as an adverse event. Safety population included participants who had enrolled in the study and took at least 1 dose of glucophage extended release (glucophage XR). If a subject experienced more than one adverse event, the subject was counted once at the highest severity.|Day 1 to Week 16|All participants enrolled in the study and who received at least 1 dose of Glucophage XR.||participants|||Number
104401|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 78, 70, and 72 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mg/L||95% Confidence Interval|Mean
104402|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL.|Baseline to Week 16|Full Analysis Set (FAS) population = 111, 111, 112 in normal, overweight, obese participants respectively. For this outcome measure, 84, 79, and 75 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||U/mL||95% Confidence Interval|Mean
104403|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 102, 95, and 85 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mg/L||95% Confidence Interval|Mean
104404|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 4, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
104613|NCT00775593|Secondary|Duration of Response|Participants who responded to treatment|At 2 years from study entry|||months||Standard Deviation|Mean
104614|NCT00775593|Secondary|Number of Serious Adverse Events Within 2 Years||At 2 years from study entry|||serious adverse events|||Number
104615|NCT00775593|Primary|Complete Response Rate||At 2 years from study entry|||participants|||Number
104405|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 2, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
104406|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set|Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 9 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
104407|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set|For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
104408|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set|Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) included enrolled participants,who took at least 1 dose of drug and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 1, and 1 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.||mmol/L||95% Confidence Interval|Mean
104409|NCT00778622|Primary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)|Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.|Baseline to Week 16|Full Analysis Set included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. Baseline data was not carried forward or averaged with on-treatment data to impute missing values for the LOCF data set.||percentage of hemoglobin||95% Confidence Interval|Mean
104410|NCT00778375|Secondary|Overall Response Rate (CR, CRp/CRi and PR)|IWG Response criteria (2003): Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L or Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 6 to 25% abnormal cells in the marrow. Participants not achieving a complete remission following first induction course, can receive a second induction course at least 28 days following first to optimize response if possible.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|Of 119 enrolled, one participant was not evaluable for response.||Percentage of Participants|||Number
104411|NCT00778375|Secondary|Event Free Survival (EFS)|EFS is defined as length of time after primary treatment for a cancer ends that the participant remains free of certain complications or events that the treatment was intended to prevent or delay, for example but not exclusive of hematologic and non-hematologic toxicities, cumulative toxicities with consolidation courses, or emergence of resistance to the chemotherapy component of treatment.|Follow up up to 5 years/60 months.|Of 119 enrolled, one participant was not evaluable for response.||Months||Full Range|Median
104412|NCT00778375|Primary|Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|One participant of 119 treated was not evaluable for response. Twenty-two participants required re-induction.||Participants|||Number
104413|NCT00778375|Primary|Median Overall Survival (OS)|Overall survival (OS): Time from date of treatment start until date of death due to any cause.|Evaluated from treatment date until date of death, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.||Months||Full Range|Median
104414|NCT00778375|Primary|Complete Remission (CR) Rate for First 60 Participants|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days|The outcome population consisted of first sixty participants enrolled between October 2008 and January 2010, of whom 59 were evaluable for response.||Percentage of Participants|||Number
104415|NCT00778375|Primary|Disease-free (DFS) or Relapse-free Survival (RFS) Time|Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.|Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.||Months||Full Range|Median
104416|NCT00778336|Secondary|Description of Treatments by Thrombotic Condition|The # of patients that were exposed to each treatment at least once in the given thrombotic condition.|Index Procedure|||Participants|||Number
104417|NCT00778336|Secondary|Rethrombosis|The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).|3 Month Follow Up|||Participants|||Number
104418|NCT00778336|Primary|Change From Baseline to Final Angiographic Results|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician:~complete occlusion (> 90% occlusion);~substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);~partial occlusion (<50% occlusion AND <3cm in length);~patent (Without visable thrombus or occlusion).~The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value."|Index Procedure ( pre-endovascular treatment and post-endovascular treatment)|Intention to Treat (ITT)||Occlusion Index||Standard Error|Mean
104419|NCT00778310|Primary|Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo|Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.|Placebo and Drug day, 1-2 weeks apart|The number who completed both fMRI one week apart (crossover study, scanned twice||Face-Shape BOLD signal difference||Standard Deviation|Mean
104420|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline to the time complete milk tolerance was established|Data were not collected and therefore no analyses could be performed.|||||
104421|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline, Month 12, Month 24, and Month 36|Data were not collected and therefore no analyses could be performed.|||||
104422|NCT00778258|Secondary|Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk|Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk.|Month 36|Randomized and comparison participants||percent participants|||Number
104423|NCT00778258|Secondary|Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.|Baseline, Month 12, Month 24, Month 36|Intent-to-treat||Ratio||Inter-Quartile Range|Median
104424|NCT00778258|Secondary|Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat participants who achieved tolerance||months||Standard Deviation|Mean
104425|NCT00778258|Secondary|Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat||cells/µL||Inter-Quartile Range|Median
104426|NCT00778258|Secondary|Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat||kUa/L||Inter-Quartile Range|Median
104427|NCT00778258|Secondary|Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.|Baseline|Intent-to-treat||percentage of max basophil degranulation||Inter-Quartile Range|Median
104428|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat||percentage of participants|||Number
104429|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC.|12 months, 24 months, and 36 months|Randomized intent-to-treat||percentage of participants|||Number
104430|NCT00778258|Secondary|Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months|Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.|12 months, 24 months|Randomized intent-to-treat||participants|||Number
104431|NCT00778258|Primary|Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat||participants|||Number
104432|NCT00778167|Primary|Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)|Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.|From time of first dose up to 28 days|Patients were evaluated with history, physical examination, vital signs, and blood tests weekly through cycle 1 and on day 1 of each subsequent cycle. Incidence and severity of AEs were collected at each study visit and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.||Participants|||Number
104441|NCT00778102|Secondary|Relapse-Free Survival (RFS)|RFS was defined as the time from curative resection (complete resection [R0] or microscopic residual tumor [R1]) to the date of first diagnosis of relapse. For participants with curative resection and without relapse, RFS was censored at the last known relapse-free assessment. RFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.||months||95% Confidence Interval|Median
104433|NCT00778102|Secondary|Percentage of Participants With Complications Related to Second Resective Surgery|Complications related to the second resective surgery were evaluated using the NCI-CTCAE version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 = resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given AE by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent second resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (Second Surgery Subpopulation): All participants who underwent a second resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.||percentage of participants|||Number
104434|NCT00778102|Secondary|Percentage of Participants With Complications Related to First Resective Surgery|Complications related to the first resective surgery were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 equals (=) resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given adverse event (AE) by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent first resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (First Surgery Subpopulation): All participants who underwent a first resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.||percentage of participants|||Number
104435|NCT00778102|Secondary|Time to Response|Time to response according to RECIST version 1.0 was defined as the time from randomization to the date of first documented CR or PR. Participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. For participants who did not complete a confirmatory tumor assessment, time to response was censored at the date of last tumor assessment, or if unavailable, at the date of first dose. Time to response was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||months||95% Confidence Interval|Median
104436|NCT00778102|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Using RECIST version 1.0, participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. The collective percentage of participants with confirmed best overall response of CR or PR was calculated as [number of participants meeting RECIST criteria for CR or PR divided by the number of participants analyzed] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||percentage of participants||95% Confidence Interval|Number
104437|NCT00778102|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause. For participants without an event of death, OS was censored at the last-known alive date. OS was estimated by Kaplan-Meier analysis.|Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population||months||95% Confidence Interval|Median
104438|NCT00778102|Secondary|Percentage of Participants Who Died||Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population||percentage of participants|||Number
104439|NCT00778102|Secondary|Progression-Free Survival (PFS)|PFS was defined, using RECIST version 1.0, as the time from randomization to the date of first documented PD or death from any cause. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. For participants without documented PD or death, PFS was censored at the time of last tumor assessment. PFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||months||95% Confidence Interval|Median
104440|NCT00778102|Secondary|Percentage of Participants Experiencing Death or Disease Progression|PD was defined, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. The percentage of participants experiencing PD or death was calculated as [number of participants with event divided by the number of participants analyzed] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population||percentage of participants|||Number
104450|NCT00777946|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|"The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.~Additional information about Adverse Events can be found in the Adverse Event Section."|8 weeks|Safety Population consisted of all randomized participants who received study drug.||participants|||Number
104442|NCT00778102|Secondary|Percentage of Participants Experiencing Relapse Following Curative Resection|Among participants with curative resection (complete resection [R0] or microscopic residual tumor [R1]), relapse was defined as the first new occurrence of cancer or death. The percentage of participants who experienced relapse was calculated as [number of participants with a relapse event divided by the number of participants initially classified as R0 or R1 following resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.||percentage of participants|||Number
104443|NCT00778102|Secondary|Percentage of Participants With Complete or Major Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as [number of participants with complete or major response divided by the number of participants who completed the assessment] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.||percentage of participants||95% Confidence Interval|Number
104444|NCT00778102|Secondary|Percentage of Participants With Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response could not be determined in some cases and was documented as 'Unknown.' The percentage of participants within each response category was calculated as [number of participants with a given response divided by the number of participants who completed the assessment] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.||percentage of participants|||Number
104445|NCT00778102|Secondary|Time to Resection|Time to resection was defined as the time from randomization to the date of first resective surgery. For participants who did not undergo resective surgery, time to resection was censored at Day 1. Time to resection was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; prior to each cycle, and within 7 days prior to surgery; and at time of surgery)|ITT Population||months||95% Confidence Interval|Median
104446|NCT00778102|Primary|Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor|Following resective surgery, participants were evaluated for complete resection (R0) or the presence of microscopic (R1) or macroscopic (R2) residual tumor. The percentage of participants within each residual tumor classification was calculated as [number of participants with R0, R1, and/or R2 divided by the total number of participants] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population||percentage of participants||95% Confidence Interval|Number
104447|NCT00777946|Secondary|Percentage of Participants Achieving a Systolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||Percentage of participants|||Number
104448|NCT00777946|Secondary|Percentage of Participants Achieving a Diastolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||Percentage of participants|||Number
104449|NCT00777946|Secondary|Percentage of Participants Achieving Blood Pressure Control|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||Percentage of participants|||Number
104484|NCT00777556|Secondary|Participants Summarized by Repeat Use of Emergency Contraception (EC)|As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.|up to week 8|Participants dispensed the product||participants|||Number
104451|NCT00777946|Secondary|Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||mm Hg||Standard Error|Least Squares Mean
104452|NCT00777946|Primary|Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.||mm Hg||Standard Error|Least Squares Mean
104453|NCT00777855|Secondary|Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin|Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days||ng/ml||Standard Deviation|Mean
104454|NCT00777855|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin|Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days||ng/ml*h||Standard Deviation|Mean
104455|NCT00777855|Primary|S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours.|Uptake effects on warfarin pharmacokinetics during time period of hepatic organic anion-transporting polypeptide (OATP) inhibition by rifampin. Blood collection 1, 2, 4, 6, 8, and 12 hours after warfarin dosing.|0-12 hours after warfarin dosing|Each of 10 participants received both treatments separated by a minimum of 14 days; treatment sequence was randomly assigned||ng/ml*h||Standard Deviation|Mean
104456|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.||participants|||Number
104457|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.||participants|||Number
104458|NCT00777803|Secondary|Response by Patient's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104459|NCT00777803|Secondary|Responder by Patient's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104460|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104461|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104793|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
104462|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104463|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104464|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104465|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104466|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104467|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104468|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104469|NCT00777803|Primary|Responder by Independent Rater's Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.||participants|||Number
104470|NCT00777790|Primary|Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.|Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.|Day 0 and 8 and 28 days post-vaccination|GMT results were on the per-protocol population for immunogenicity.||Titer||95% Confidence Interval|Geometric Mean
104471|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:100,000 dilutions: n=30; for 1:10,000 dilutions: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)||participants|||Number
104485|NCT00777556|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.|Day 1 to week 8|Safety population of participants who took study drug||participants|||Number
104472|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:1000 dilutions: n=27; for 1:100 dilutions: n=21; for 1:10 dilutions: n=13. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)||participants|||Number
104473|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)|For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. For healthy volunteer cohort, undiluted: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)||participants|||Number
104474|NCT00777764|Primary|Number of Participants by of Adverse Events Following a Skin Test Procedure|"Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours.~Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death."|Up to 7 days following skin testing|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient.||participants|||Number
104475|NCT00777634|Primary|Incidence of Diagnosis of Three or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years|||participants|||Number
104476|NCT00777634|Primary|Incidence of Diagnosis of Two or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years|||participants|||Number
104477|NCT00777634|Primary|Incidence of Diagnosis of Any Metabolic Syndrome Component|The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years|||participants|||Number
104478|NCT00777634|Primary|Incidence of Diagnosis of Type 2 Diabetes|The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.|Baseline to 5 years|||participants|||Number
104479|NCT00777634|Primary|Incidence of Diagnosis of Hypertension|The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.|Baseline to 5 years|||participants|||Number
104480|NCT00777634|Primary|Incidence of Diagnosis of Dyslipidemia|The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.|Baseline to 5 years|||participants|||Number
104481|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12|"The ADAS-Cog is a psychometric instrument that evaluates memory, attention,~reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline."|Baseline and 4 weeks, 8 weeks and 12 weeks.|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).||Score on a scale||Standard Error|Least Squares Mean
104482|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.|Baseline and 2 weeks, 8 weeks and 12 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).||Score on a scale||Standard Error|Least Squares Mean
104483|NCT00777608|Primary|Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.|Baseline and 4 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).||Score on a scale||Standard Error|Least Squares Mean
104794|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
104486|NCT00777556|Primary|Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions|The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.|Week 1|Eligible participants who appropriately self-selected and used the product.||percentage of treated participants||95% Confidence Interval|Number
104487|NCT00777556|Primary|Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions|The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.|Day 1|Enrolled participants||percentage of participants||95% Confidence Interval|Number
104488|NCT00777335|Secondary|Corrected QT Interval Fridericia's Formula (QTcF)|Prolonged QTcF: QTcF >450 msec and increase of baseline on greater than or equal to 60 msec.|Panobinostat intra-venous (i.v.): All cycles pre-dose measurements. For cycles 1 and 2, post-dose measurements as well. / Panobinostat oral: Pre-dose and post-dose measurements for all cycles. Note: each cycle = 3 weeks|||participants|||Number
104489|NCT00777335|Primary|Overall Response (OR) Rate (as Determined by the Investigator): the Number of Patients Assigned to a Treatment Arm With a Confirmed Best Response of Complete Response(CR) or Partial Response (PR).|"The assessment of OR is based on the response of target lesion, of non-target lesion and on presence of new lesions (RECIST Criteria (V1.0)-assessed by CT scan spiral and bone scan)~CR:Disappearance of all target lesions~PR:>=30% increase in the sum of the longest diameter (SLD),taking as reference the nadir SLD~Progressive Disease (PD):>=20% increase in the SLD, taking as reference the nadir SLD, or the appearance of one or more new lesions~Stable Disease(SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the nadir SLD"|At screening, every 2 cycles (i.e. 6 weeks) during the first 6 cycles, every 3 cycles (i.e. 9 weeks) during the subsequent cycles and at the End of Treatment (EOT) visit. After the EOT, the tumor assessments should be performed every 9 weeks.|||participants|||Number
104490|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 Post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
104491|NCT00777257|Secondary|Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.|Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.|0 to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population||Percentage of participants|||Number
104492|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
104493|NCT00777257|Primary|Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.||Day 0 to Day 28 post-vaccination|Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population||Percentage of participants|||Number
104494|NCT00777205|Primary|Recovery Orientation|The 30-item Mental Health Recovery Measure (MHRM) was used to assess recovery orientation. The MHRM has been fielded among diverse populations and has a high level of internal consistency (Cronbach’s α =.93) and shows change following engagement in recovery oriented treatments. The MHRM is scored using a 5 point Likert Scale (0 to 4) for each item, yielding a theoretical range from 0 – 120 for Total Score. Higher scores correspond to a higher self-reported level of mental health recovery.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
104495|NCT00777205|Primary|Depression Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
104496|NCT00777205|Primary|Quality of Life|The 14-item Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), which has good reliability and has been used in multiple depression studies, was used to assess quality of life. Responses are scored on a 5-point scale (‘not at all or never’ to ‘frequently or all the time’), where higher scores indicate better enjoyment and satisfaction with life (possible range 14–70).|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
104497|NCT00777205|Primary|Change in Functional Status-Physical Health (PCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
104795|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
104498|NCT00777205|Primary|Change in Functional Status-Mental Health (MCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.||units on a scale||Standard Deviation|Mean
104499|NCT00777179|Secondary|Objective Response Rate (ORR)|"Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response."|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.|||Participants|||Number
104500|NCT00777179|Secondary|Disease of Response (DOR)|"Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response"|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.|||Participants|||Number
104501|NCT00777179|Secondary|Overall Survival (OS)|Overall survival (OS) defined as the median time from randomization to death from any cause.|Every 12 weeks unless the patient withdraws consent|||months||95% Confidence Interval|Median
104502|NCT00777179|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.|||months||95% Confidence Interval|Median
104503|NCT00777179|Primary|Progression-free Survival (PFS) Rate at 3 Months|Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.|12 weeks|The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.||Participants|||Number
104504|NCT00777153|Secondary|Steroid Free Days|Number of days known not to have used any steroids prior to progression|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25|||Days||Standard Deviation|Mean
104505|NCT00777153|Secondary|Daily Steroid Dose|The mean steroid dosage prior to treatment will be considered as the patient’s baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md – bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25|||percentage of change|||Number
104506|NCT00777153|Secondary|Alive and Progression Free Rate at 6 Months (APF6)|Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.|6 Months|||% of patients alive and progression free|||Number
104507|NCT00777153|Secondary|Response Rate|"An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.~An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan."|Baseline at 6 weeks and then every 6 weeks to discontinuation|Patients are only included in the analysis if they have measurable disease at baseline based on central.||Participants|||Number
104508|NCT00777153|Secondary|Overall Survival (OS)|Number of months from randomisation to the date of death from any cause|Baseline through to date of death up to 25th April 2010|||Months||Inter-Quartile Range|Median
104509|NCT00777153|Primary|Progression Free Survival (PFS)|"For patients with measurable disease at entry (at least one lesion that has a shortest diameter~≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:~The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.~The patient has died from any cause.~A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm."|Baseline at 6 weeks and then every 6 weeks to discontinuation|||Days||Inter-Quartile Range|Median
104510|NCT00777062|Primary|Time Line Follow Back -Reported Days of Abstinence From Drinking|Percentage of participants who were abstinent from drinking|8 week medication phase|||Percentage of Participants|||Number
104511|NCT00777062|Primary|Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.|Percentage of subjects with no cocaine use for at least 3 weeks|8 week medication phase|||Percentage of Participants|||Number
104512|NCT00777049|Primary|Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.|The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).|6 years and 2 months|||participants|||Number
104616|NCT00775528|Primary|Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)|Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.|10 Days|||Participants|||Number
104514|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 4 weeks of treatment|Intent to treat population||Units on a scale||95% Confidence Interval|Least Squares Mean
104515|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 12 weeks of treatment|Intent to treat population||Hot flashes||95% Confidence Interval|Least Squares Mean
104516|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 4 weeks of treatment|Intention to treat population||Hot flashes||95% Confidence Interval|Least Squares Mean
104517|NCT00776997|Secondary|Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline||12 months|||participants|||Number
104518|NCT00776997|Secondary|At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline||12 months|||participants|||Number
104519|NCT00776997|Primary|Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.|The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.|12 Months|||participants|||Number
104520|NCT00776997|Primary|Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).|"SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria:~Results in death~Is life-threatening~Requires subject hospitalization > 24 hours~Requires prolongation of an existing hospitalization~Results in persistent or significant disability/incapacity~Results in fetal distress, fetal death, or a congenital anomaly or birth defect~Requires intervention to prevent permanent impairment or damage.~Outcome measure reports number of subjects with reported events."|through 24 months|||participants|||Number
104521|NCT00776984|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)||percentage of participants|||Number
104522|NCT00776984|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Puffs||Standard Error|Mean
104523|NCT00776984|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Days||Standard Error|Mean
104524|NCT00776984|Secondary|ACQ Score at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
104525|NCT00776984|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Score on a scale||Standard Error|Mean
104526|NCT00776984|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
104527|NCT00776984|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
104528|NCT00776984|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
104530|NCT00776984|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As < 50 percent (10 of 232 patients in the placebo group and 8 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
104531|NCT00776984|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.||Participants|||Number
104532|NCT00776984|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.||Participants|||Number
104533|NCT00776984|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.||Participants|||Number
104534|NCT00776984|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.||Participants|||Number
104535|NCT00776984|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As < 50 percent (81 of 232 patients in the placebo group and 69 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
104536|NCT00776984|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Percent||Standard Error|Mean
104537|NCT00776984|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
104538|NCT00776984|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
104539|NCT00776984|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
104540|NCT00776984|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
104541|NCT00776984|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
104542|NCT00776984|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
104543|NCT00776984|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
104544|NCT00776984|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
104545|NCT00776984|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
104546|NCT00776984|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
104547|NCT00776984|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
104548|NCT00776984|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
104549|NCT00776984|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
104550|NCT00776984|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
104551|NCT00776984|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||Days||Inter-Quartile Range|Median
104552|NCT00776984|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
104553|NCT00776984|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.||Liter||Standard Error|Mean
104554|NCT00776919|Secondary|Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation|An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.|Baseline (Day 1) through Week 12|ITT Population||participants|||Number
104555|NCT00776919|Secondary|Mean Duration of Study Product Use|Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.|Baseline (Day 1) through Week 12|ITT Population||days||Standard Deviation|Mean
104556|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging|Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.||scores on a scale||Standard Deviation|Mean
104557|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling|Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.||scores on a scale||Standard Deviation|Mean
104558|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Pulse Rate|Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.||Beats per minute (bpm)||Standard Deviation|Mean
104559|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Temperature|Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.||Degrees centigrade||Standard Deviation|Mean
104560|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
104561|NCT00776919|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score >=2.||participants|||Number
104562|NCT00776919|Secondary|Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12|During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score >=2.||participants|||Number
104563|NCT00776919|Secondary|Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.||Percent change in lesion counts||Standard Deviation|Mean
104564|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Total Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.||lesion counts||Standard Deviation|Mean
104565|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.||lesion counts||Standard Deviation|Mean
104796|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
104566|NCT00776919|Primary|Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.||lesion counts||Standard Deviation|Mean
104567|NCT00776919|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Baseline (Day 1) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.||participants|||Number
104568|NCT00776789|Secondary|Breast Feeding Status at 6 Weeks|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases|6 weeks|||percentage of partcipants|||Number
104569|NCT00776789|Secondary|Breast Feeding Status at 48 Hours|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases.|48 hours|EBF rates were assessed using the standard WHO definitions. We asked the mothers about the method of feeding and the number and amount of supplemental feeds received in the first 2 days of life. Breastfeeding rates at 6 weeks were obtained by enquiring from the mothers at the time of the first vaccination of their infants in the follow-up clinic.||percentage of partcipants|||Number
104570|NCT00776789|Secondary|Salivary Cortisol|Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA).|6 hours|||microgram/dl||Inter-Quartile Range|Median
104571|NCT00776789|Primary|The Median Breast Feeding Score|This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure [0 to 3] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more >=8.|36-48 hours by video recording|||scores||Inter-Quartile Range|Median
104572|NCT00776659|Primary|Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.|||||
104573|NCT00776659|Primary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.|||||
104574|NCT00776659|Primary|Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.|Baseline up to 28 days after last dose of study treatment|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.||participants|||Number
104575|NCT00776659|Primary|Number of Participants Who Discontinued Aromasin Therapy||Baseline until discontinuation (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.||participants|||Number
104576|NCT00776659|Primary|Number of Participants Who Died||Baseline until death (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.||participants|||Number
104577|NCT00776659|Primary|Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer||Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
104578|NCT00776659|Primary|Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer|Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.|Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
104579|NCT00776594|Secondary|Analysis of Cytokines and Angiogenic Factors in Plasma/Serum|Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).|6 months|||pg/ml||Inter-Quartile Range|Median
104580|NCT00776594|Secondary|Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).|The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.|6 months|||participants|||Number
104581|NCT00776594|Secondary|Number of Participants With PSA <0.2 ng/ml at Six Months|Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).|Six months (at completion of treatment)|||Number of participants|||Number
104582|NCT00776594|Primary|Relapse-free Survival|To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.|2 years|||months||95% Confidence Interval|Median
104583|NCT00776555|Secondary|DRQ-S, Question 3|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.|||||
104584|NCT00776555|Secondary|DRQ-S, Question 1|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.|||||
104585|NCT00776555|Primary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.|||||
104586|NCT00776295|Secondary|3 Year Progression-free Survival|3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC|up to 3 years|||participants|||Number
104587|NCT00776295|Primary|Number of Subjects Meeting 1-year Overall Survival|Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death|up to one year|||participants|||Number
104588|NCT00776230|Secondary|Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability||see above||||||
104589|NCT00776230|Primary|Primary: 1. Geometric Mean Titers (GMT) at Day 56||56 days post 1st vaccination|Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication||Geometric Mean Titer - Estimate||95% Confidence Interval|Geometric Mean
104590|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement.||Number correct||Standard Error|Least Squares Mean
104591|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Number attempted||Standard Error|Least Squares Mean
104592|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Scores on a scale||Standard Error|Least Squares Mean
104617|NCT00775528|Secondary|Total Calorie Intake (kcal)|The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.||Kcal||Standard Deviation|Mean
104593|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Scores on a scale||Standard Error|Least Squares Mean
104594|NCT00776009|Primary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement||Scores on a scale||Standard Error|Least Squares Mean
104595|NCT00775983|Secondary|Participants Who Experienced Complications or Need for Additional Dilation|Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.||participants|||Number
104596|NCT00775983|Primary|Procedure Time|Procedure time to complete early second-trimester dilation and evacuation (D&E)|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.||minutes||Standard Error|Mean
104597|NCT00775944|Secondary|Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)|Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.|Measured 6 months after participant's quit date||||||
104598|NCT00775944|Secondary|Health Status at 6 Months EuroQol 5D (EQ5D)|This is a generic measure of health status used in health economic analyses.|Measured 6 months after participant's quit date||||||
104599|NCT00775944|Secondary|Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months|As title|Measured 6 months after participant's quit date||||||
104600|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month|Participants had to report not smoking for 7 or more days prior to outcome ascertainment.|Measured at 1 month after participant's quit date|All randomised cases||participants|||Number
104601|NCT00775944|Secondary|Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month|Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked.|Measured at 1 month after participant's quit date|All randomised cases||participants|||Number
104602|NCT00775944|Secondary|Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months|Participants had to report not smoking in the three months prior to outcome ascertainment.|Measured at 6 months after participant's quit date|All randomised cases||participants|||Number
104603|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.|The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.|Measured 6 months after participant's quit date|||participants|||Number
104604|NCT00775944|Primary|Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.|Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period.|6 months from participant's quit date|All randomised cases||participants|||Number
104605|NCT00775671|Primary|Marker of Fibrinolysis|Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.|After 12 weeks of study drug|||ng/mL||Standard Deviation|Mean
104606|NCT00775671|Secondary|Measurement of Insulin Sensitivity|The change in insulin sensitivity index, from baseline to after 12 weeks of treatment. Calculated from the intravenous glucose tolerance test at baseline and at 12 weeks.|3 hours|||10-4xmin-1 per mU/L||Standard Deviation|Mean
104607|NCT00775606|Secondary|Response to Immunization With Pneumococcus Polysaccharide and Tetanus-diphtheria Vaccines|Response to immunization with pneumococcus polysaccharide and tetanus-diphtheria vaccines was not done due to small sample size|4 weeks after treatment initiation||||||
104608|NCT00775606|Secondary|Activated and Regulatory CD4+ and CD8+ T-cell Frequencies||4, 12 and 24 weeks after treatment initiation||||||
104609|NCT00775606|Secondary|Naive, Central Memory and Effector Memory CD4+ and CD8+ (Cluster of Differentiation 8) T-cell Frequency||4, 12 and 24 weeks after treatment initiation||||||
104610|NCT00775606|Secondary|CD4+ T-cell Change|This measures the change in CD4+ T-cells from baseline to week 24 of treatment.|24 weeks after treatment initiation (baseline and week 24)|||cells/mm3||Standard Deviation|Mean
104611|NCT00775606|Primary|CD4+ (Cluster of Differentiation 4) T-cell Apoptosis|Change in the percentage of naive CD4 T-cells undergoing apoptosis as measured by propidium iodide staining. This is a lab test that measures the percentage of naive CD4 T-cells that are undergoing cell death. The change in this measure is obtained by determining the difference between the percentage of naive CD4 T-cells undergoing apoptosis at week 24 of treatment and the percentage undergoing apoptosis at baseline.|24 weeks from treatment initiation (baseline and week 24)|||per cent||Standard Deviation|Mean
104612|NCT00775593|Secondary|Duration of Survival||At 2 years from study entry|||months||Full Range|Median
104619|NCT00775528|Secondary|Stool Fat (% Fat)|The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.||Percentage of fat||Standard Deviation|Mean
104620|NCT00775463|Secondary|Time to Ulcer Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial. The time to complete healing of all ulcers were calculated as the number of days from randomization to the date of these respective assessments, provided that complete healing was achieved during the study.|Week 20|||days||Standard Deviation|Mean
104621|NCT00775463|Secondary|Time to Ulcer Healing- Percentage of Subjects With Complete Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial.|Week 20|||percentage of participants|||Number
104622|NCT00775463|Secondary|Short Form 36|Change in patient quality of life was measured by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), a self-administered questionnaire covering eight areas: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health. For each area, the score range from 0 (poorer health status) to 100 (better health status). The SF-36 is one of the most widely used and validated instruments to assess quality of life in patients with systemic illnesses. A decrease (negative change) in a domain score corresponds to deterioration.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
104623|NCT00775463|Secondary|Patient Impression of Change (PIC) Questionnaire|The PIC questionnaire consisted of three Likert items that asked the subject to rate changes in their digital ulcer, Raynaud’s phenomenon and disease status since their last visit on a seven-level scale (very much improved, much improved, somewhat improved, same, somewhat worse, much worse and very much worse).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||participants|||Number
104624|NCT00775463|Secondary|Short-Form McGill Pain Questionnaire|The SF-MPQ assessment has three component scores: the pain rating index (PRI), a pain visual analogue numerical scale (Pain VAS) and the present pain intensity (PPI). PRI is calculated by summing the responses (0=None to 3=Severe) to the 15 questions describing pain during the previous week and rated on an intensity scale as 0= none, 1= mild, 2= moderate or 3= severe and has possible values ranging from 0 to 45. The Pain VAS is a 100 mm VAS on which subjects were asked to rate pain during the previous week with values ranging from no pain (0.0) to worst possible pain (10.0). The PPI rated pain on a 6-point category scale from 0 (no pain) to 5 (excruciating pain).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
104625|NCT00775463|Secondary|Modified Rodnan Skin Score (mRSS)|The skin thickening was assessed by the Investigator in 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each area was scored 0–3; 0 representing normal skin and 3 being severe thickening. The mRSS was the sum of the individual skin assessment scores: possible range of 0-51; 0 (no thickening) to 51 (severe thickening in all 17 areas) .|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
104626|NCT00775463|Secondary|Scleroderma Health Assessment Questionnaire (SHAQ)|The SHAQ is a patient self-administered instrument which has been previously validated in SSc and demonstrates meaningful clinical changes in the course of the disease over time. It is comprised of a 20 question instrument pertaining to specific activities with possible integer responses of 0 (without any difficulty) to 3 (unable to do), and five additional scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud’s Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with possible values ranging from 0.0 to 15.0. The 20 questions are divided into eight domains. A mean score is calculated for each domain ranging from 0 to 3. A composite HAQ DI score is calculated by dividing the summed domain scores by the number of domains answered. The composite score is reported, falling between 0 and 3 on an ordinal scale. The scores are interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
104627|NCT00775463|Secondary|Cochin Hand Function Scale (CHFS)|The CHFS has been demonstrated as a reliable and valid assessment of hand function at the activity level in persons with SSc. It is comprised of 18 questions with possible integer responses of 0 (without difficulty) to 5 (impossible). The CHFS Score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS Score values can range from 0 (least limitation) to 90 (most limitation). A higher score indicates more difficulty in hand function or greater disability.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||95% Confidence Interval|Median
104628|NCT00775463|Secondary|Physician Global Assessment of Digital Ulcer Severity VAS|"Physicians rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
104629|NCT00775463|Secondary|Patient Global Assessment of Digital Ulcer Severity VAS|"Patients rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
104630|NCT00775463|Secondary|Digital Ulcer Pain VAS|Digital ulcer pain was rated on a 100-mm VAS on which subjects were asked to rate their average overall hand pain during the last week. The recorded value was divided by 10, with values ranging from 0.0 (no pain) to 10.0 (unbearable pain), expressed to one decimal.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation||units on a scale||Inter-Quartile Range|Median
104631|NCT00775463|Primary|Net Ulcer Burden|Net ulcer burden was defined as the number of “new” or “active” digital ulcers (DU), plus the number of “indeterminate” DUs at that assessment that have previously been classified as either “active” or “new” at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced “active.” If denudation could not be judged because of the presence of scab or necrotic tissue, DU presenting with features, including underlying pain, based on Investigator clinical judgment to be consistent with loss of epithelialization, epidermis, or dermis, and requiring treatment were designated as “active.” Otherwise, the DU was pronounced “indeterminate.” Only DUs distal to the proximal interphalangeal joints, volar to the equator of the finger, not localized in creases and vascular in origin were assessed.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change.||ulcers||Inter-Quartile Range|Median
104632|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
104633|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.|Days 0 and 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
104634|NCT00775450|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
104635|NCT00775450|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.|Days 0 through 7 post vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Participants|||Number
104636|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104637|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104797|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
104638|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104639|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104640|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104641|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104642|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104643|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104644|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104645|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104646|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104798|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|days of observation||Number
104799|NCT00774163|Primary|Serum Creatinine||Day 5|||mg/dl||Standard Deviation|Mean
104647|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104648|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104649|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.|||units on a scale||Standard Deviation|Mean
104650|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104651|NCT00775437|Secondary|Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit|"Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104652|NCT00775437|Secondary|Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit|"Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present (1), absent (0) or replaced/injected (9). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104653|NCT00775437|Secondary|Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit|"Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present (1), absent (0) or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104654|NCT00775437|Secondary|C-reactive Protein (CRP): Mean Change From Baseline to Each Visit|CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||mg/dL||Standard Deviation|Mean
104655|NCT00775437|Secondary|Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit|"Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104800|NCT00774163|Primary|Blood Urea Nitrogen||Day 5|||mg/dl||Standard Deviation|Mean
104801|NCT00774163|Primary|Serum AST in Males||Day 5|limited to males||units per liter (U/L)||Standard Deviation|Mean
104656|NCT00775437|Secondary|Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit|A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104657|NCT00775437|Secondary|Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit|The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104658|NCT00775437|Secondary|Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The parent’s assessment of how the participant’s arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104659|NCT00775437|Secondary|Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The physician’s assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||units on a scale||Standard Deviation|Mean
104660|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)|The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
104661|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)|The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
104662|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)|The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
104663|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)|The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||percentage of participants|||Number
104802|NCT00774163|Primary|Serum Aspartate Aminotransferase (AST) in Females||Day 5|limited to females||units per liter (U/L)||Standard Deviation|Mean
104664|NCT00775437|Secondary|Uric Acid: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||µmol/L||Standard Deviation|Mean
104665|NCT00775437|Secondary|Creatinine: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||µmol/L||Standard Deviation|Mean
104666|NCT00775437|Secondary|Total Bilirubin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||µmol/L||Standard Deviation|Mean
104667|NCT00775437|Secondary|Creatine Phosphokinase: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
104668|NCT00775437|Secondary|Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
104669|NCT00775437|Secondary|Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug.Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
104670|NCT00775437|Secondary|Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||U/L||Standard Deviation|Mean
104671|NCT00775437|Secondary|Basophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
104672|NCT00775437|Secondary|Eosinophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
104673|NCT00775437|Secondary|Monocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
104674|NCT00775437|Secondary|Lymphocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄9/L||Standard Deviation|Mean
104675|NCT00775437|Secondary|Neutrophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄9/L||Standard Deviation|Mean
104676|NCT00775437|Secondary|White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10^9/L||Standard Deviation|Mean
104677|NCT00775437|Secondary|Platelets: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄9/L||Standard Deviation|Mean
104678|NCT00775437|Secondary|Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||x10˄12/L||Standard Deviation|Mean
104679|NCT00775437|Secondary|Hematocrit: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||Fraction||Standard Deviation|Mean
104680|NCT00775437|Secondary|Hemoglobin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120|||g/L||Standard Deviation|Mean
104681|NCT00775437|Secondary|Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24|Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.|Weeks 0, 12, and 24|All participants who had samples for pharmacokinetic analysis||µg/mL||Standard Deviation|Mean
104682|NCT00775437|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).|TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).|||participants|||Number
104683|NCT00775411|Secondary|Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).|Baseline, Week 26|Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26.||Percentage of participants|||Number
104684|NCT00775411|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 26|Intent to treat population consisting of all enrolled participants.||Number of letters||Standard Deviation|Mean
104685|NCT00775411|Primary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.|Baseline, Week 4|Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses.||Microns||Standard Deviation|Mean
104686|NCT00775346|Primary|Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).|Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).|9 Hours|||Ratio||90% Confidence Interval|Mean
104687|NCT00775229|Secondary|Liver Function Tests|Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).|Week 8 (last visit)|||percentage of individuals with LFT chang|||Number
104688|NCT00775229|Secondary|Massachusetts General Hospital Hairpulling Scale|Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).|||units on a scale||Standard Deviation|Mean
104689|NCT00775229|Primary|National Institute of Mental Health Trichotillomania Symptom Severity Scale|Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).|||units on a scale||Standard Deviation|Mean
104690|NCT00775203|Secondary|Discontinuation Due to Lack of Efficacy|Number of patients who discontinued due to lack of efficacy during the whole study period (8 weeks).|Baseline to Week 8|Safety population is defined as all randomized patients who received any study medication.||participants|||Number
104691|NCT00775203|Secondary|Awakening During the Night at Each Visit|"Awakening during the night was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit did you awaken during the night?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
104692|NCT00775203|Secondary|Trouble Falling Asleep at Each Visit|"Trouble Falling Asleep was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit, how often did you experience trouble falling asleep?."|Weeks 1, 2, 3, 4, 6, 8|Full Analysis set (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
104693|NCT00775203|Secondary|Overall Quality of Sleep at Each Visit|"Overall Quality of Sleep was measured on a 4-point rating scale ranging from 1 = very poor to 4 = excellent in response to the question: Since the last study visit, how would you rate the overall quality of your sleep?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Points on a scale||Standard Deviation|Mean
104803|NCT00774163|Primary|Serum ALT in Males||Day 5|limited to males||units per liter (U/L)||Standard Deviation|Mean
104694|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Responders at Last Study Visit|Patients were responders if the PGI-I rating was “Much Improved” or “Very Much Improved”. The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Responders Week 8 Observed Cases: Trazodone = 176, placebo = 183.||participants|||Number
104695|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Responders at Last Study Visit|Patients were responders if the CGI-I rating was “Much Improved” or “Very Much Improved”. The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Responders Week 8 Observed Cases: Trazodone = 180, placebo = 183.||participants|||Number
104696|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Score at Last Study Visit|The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Week 8 Observed Cases: Trazodone = 176, placebo = 183.||Units on PGI-I scale||Standard Deviation|Mean
104697|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Score at Last Study Visit|The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Week 8 Observed Cases: Trazodone = 178, placebo = 182.||Units on the CGI-I scale||Standard Deviation|Mean
104698|NCT00775203|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Each Visit|The CGI-Severity (CGI-S) consists of one question for the investigator: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Units on CGI-S scale||Standard Deviation|Mean
104699|NCT00775203|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10 item clinician-administered depression rating scale. The 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) are rated on a scale ranging from 0 (low severity/difficulty) to 6 (high severity/difficulty) with anchors at 2-point intervals. The overall total score range is from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. MADRS Week 8 Observed Cases: Trazodone = 178, placebo = 182.||Units on MADRS scale||Standard Deviation|Mean
104700|NCT00775203|Secondary|Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit|Change from baseline in the HAMD-17, item 1: Depressed Mood item, at each post-baseline visit. The Depressed Mood item is rated on a 5-point scale ranging from rating of 0=absent; to 4=very severe.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Points on the HAMD scale||Standard Deviation|Mean
104701|NCT00775203|Secondary|HAMD-17 Remitters at Each Visit|Number of patients who are remitters (defined as patients who achieved a HAMD-17 total score ≤7) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Participants|||Number
104702|NCT00775203|Secondary|HAMD-17 Responders at Each Visit|Number of patients who show a response (defined as at least a 50% reduction from baseline in HAMD-17 score) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).||Participants|||Number
104716|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
104703|NCT00775203|Primary|Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline|The Hamilton Depression Rating Scale 17 items [HAMD-17] is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Week 8 Last Observation Carried Forward (LOCF): Trazodone = 202, placebo = 204.||Points on HAMD-17 scale||Standard Deviation|Mean
104704|NCT00775021|Secondary|Overall Lens Handling|Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
104705|NCT00775021|Secondary|Initial Comfort|Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 Week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
104706|NCT00775021|Secondary|End of the Day Comfort|Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
104707|NCT00775021|Secondary|Inferior Region Corneal Staining|The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
104708|NCT00775021|Primary|Overall Comfort|Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.||units on a scale||Standard Error|Least Squares Mean
104709|NCT00774995|Secondary|Number of Subjects That Experienced Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period after the challenge dose (1 month).|||Subjects|||Number
104710|NCT00774995|Secondary|Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination.|During the 31-day follow-up period after the hepatitis B vaccine challenge dose.|||Subjects|||Number
104711|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
104712|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||mIU/mL||95% Confidence Interval|Geometric Mean
104713|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||mIU/mL||95% Confidence Interval|Geometric Mean
104714|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.|Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
104715|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.|Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.||Subjects|||Number
104804|NCT00774163|Primary|Serum Alanine Aminotransferase (ALT) in Female Participants||Day 5|limited to females||units per liter (U/L)||Standard Deviation|Mean
104805|NCT00774163|Primary|Leukocyte Count on Day 5||Measured on day 5|||cells per cubic millimeter||Standard Deviation|Mean
104717|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||μmol/day||Standard Deviation|Mean
104718|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||μg/L||Standard Deviation|Mean
104719|NCT00774930|Secondary|Changes From Baseline in QoL in “Endocrine Symptoms” Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||Units on a scale||Standard Deviation|Mean
104720|NCT00774930|Secondary|Changes From Baseline in “Gastrointestinal (G.I). Symptoms” Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||Units on a scale||Standard Deviation|Mean
104721|NCT00774930|Secondary|"Changes From Baseline in Global Health Status/Quality of Life (QoL) Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)"|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.~For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.||Units on a scale||Standard Deviation|Mean
104722|NCT00774930|Secondary|Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study|Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Percentage of subjects|||Number
104723|NCT00774930|Secondary|Percentage of Days of Use of Other Rescue Medication|Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Percentage of days||Standard Deviation|Mean
104724|NCT00774930|Secondary|Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Number of events per day||Standard Deviation|Mean
104725|NCT00774930|Secondary|Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Number of events per day||Standard Deviation|Mean
104806|NCT00774163|Primary|Mean Daily Temperature|Measured daily during 5 days of study product administration|5 days of study product administration|||Degrees Celcius||Standard Deviation|Mean
104726|NCT00774930|Primary|Percentage of Days With Subcutaneous Octreotide as Rescue Medication|Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.||Percentage of days||95% Confidence Interval|Least Squares Mean
104727|NCT00774852|Secondary|Proportion of Vaccinated Participants With a Competent Immune Response|"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:~Pneumococcal vaccination response – absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.~Tetanus toxoid vaccination response – absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer~Competent immune response is indicative of low disease activity."|Week 52|Intent-to-treat who completed Week 52 and were vaccinated.||percentage of participants|||Number
104728|NCT00774852|Secondary|Lupus Disease Activity – Total BILAG-2004|BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.|Week 52|Intent-to-treat who completed Week 52 and BILAG 2004 data available.||units on a scale||Standard Deviation|Mean
104729|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.||percent change||Standard Deviation|Mean
104730|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.||Score||Standard Deviation|Mean
104731|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.||percent change||Standard Deviation|Mean
104732|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.||units on a scale||Standard Deviation|Mean
104733|NCT00774852|Secondary|Lupus Disease Activity – Frequency of Flares|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity."|Week 52|Intent-to-treat with available data between weeks 24 and 52.||participants|||Number
104754|NCT00774748|Primary|Average Subcutaneous Anti-Xa Blood Levels|Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.|approximately 3 months|Participants were separated into the two dosing schedules, since the target anti-Xa level is different for the two different types of doses.||IU/mL||Full Range|Mean
104734|NCT00774852|Secondary|Lupus Disease Activity – Presence of Hypocomplementemia|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus."|Week 104|Intent-to-treat participants who completed Week 104 and had hypocomplementemia data available||participants|||Number
104735|NCT00774852|Secondary|Lupus Disease Activity – Negative Anti-dsDNA|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity."|Week 104|Intent-to-treat participants who completed Week 104.||participants|||Number
104736|NCT00774852|Secondary|Lupus Disease Activity – Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity."|Week 104|Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104.||participants|||Number
104737|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response|A participant who did not meet the criteria for either a complete response (CR) or a partial response (PR) at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the investigator judged that the participant may benefit from continued participation. CR definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a CR. PR definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline, and prednisone dose has been tapered to 10 mg/day.|Week 52|Intent-to-treat|||||
104738|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study|A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe.|Week 104|Intent-to-treat||participants|||Number
104739|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response|A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
104740|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response|A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
104741|NCT00774852|Secondary|Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis.|Week 52|Intent-to-treat||participants|||Number
104742|NCT00774852|Secondary|Number of Participants With a Complete or Partial Response|"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.~Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.~Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis."|Week 52|Intent-to-treat||participants|||Number
104771|NCT00774397|Secondary|Change From Baseline to Week 24 in Weight of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Weight at Week 24)||kg||Standard Deviation|Mean
104743|NCT00774852|Secondary|Number of Participants With Partial Response|Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
104744|NCT00774852|Primary|Number of Participants With Complete Response|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat||participants|||Number
104745|NCT00774800|Secondary|Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])|AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose.|Predose up to 4 hours after injection of study drug|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC(BG) data.||minutes*milligrams per deciliter||90% Confidence Interval|Geometric Mean
104746|NCT00774800|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable tmax data.||minutes||Standard Deviation|Mean
104747|NCT00774800|Secondary|Maximum Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable Cmax data||Picomoles per liter (pmol/L)||Standard Deviation|Mean
104748|NCT00774800|Primary|Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)|AUC was derived as the area under the serum insulin concentration profile from 0 to time “t.” Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose.|Predose up to 60 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC0-60 data.||nanomole*minute per liter (nmol*min/L)||Standard Deviation|Mean
104749|NCT00774787|Other Pre-specified|Local Skin Reactions|Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|Post baseline to end of study (4-8 weeks post-treatment)|One patient not included who was lost to follow-up immediately after baseline visit, and had no post-treatment data.||Scores on a scale||Standard Deviation|Mean
104750|NCT00774787|Secondary|Cosmetic Appearance Score at 4-8 Weeks Post-treatment|Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|4-8 weeks post-treatment|Patients who had end of study visit with cosmetic appearance assessment. Cosmetic appearance score, by treatment area, not included for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data.||Scores on a scale||Standard Deviation|Mean
104751|NCT00774787|Post-Hoc|Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment|Complete clearance (actinic keratosis count of 0) in each respective area at 4-8 weeks post-treatment. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|4-8 weeks post-treatment|All patients enrolled.||Participants|Participants||Number
104752|NCT00774787|Primary|Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment|Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|Baseline, 4-8 weeks post-treatment|Patients who had end of study visit with count of actinic keratoses. Change not calculated for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline or new.||Percent change||Standard Deviation|Mean
104753|NCT00774748|Secondary|Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)|GFR was calculated from a creatinine blood level to establish a safe renal function that would validate anti-Xa levels. Low molecular weight heparin is primarily cleared from the body by the kidneys. Any condition that decreases kidney function can potentially decrease LMWH clearance, increasing its concentration in the blood and increasing the potential for excessive bleeding.|6 time points in approximately 3 months|Included all participants who had at lease one visit and one blood draw.||mL/min||Full Range|Mean
104755|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7|Comparing anti-Xa levels from the first day of using the port and the last day of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|7 days|All participants, excluding two outliers of 97% and 150%||Percent||Full Range|Median
104756|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port|Comparing subcutaneous baseline (without port) anti-Xa levels with day one of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|approximately 3 months|Twenty participants, excluding one outlier of 97%.||Percent||Full Range|Median
104757|NCT00774748|Secondary|Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels|Anti-Xa subcutaneous blood levels are displayed in percent difference to show normal fluctuations of anti-Xa levels without using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|6 time points (for each participant) in approximately 3 months|All participants were represented with a baseline fluctuation in percent difference.||Percent||Full Range|Median
104758|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of PegIFN at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
104759|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
104760|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
104761|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Faldaprevir at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
104762|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline Total Bilirubin)||percentage of patients|||Number
104763|NCT00774397|Secondary|Change From Baseline to Week 24 in Total Bilirubin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Total Bilirubin at Week 24)||mg/dL||Standard Deviation|Mean
104764|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline ALT/GPT,SGPT)||percentage of patients|||Number
104765|NCT00774397|Secondary|Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients|Baseline is defined as the last value before the drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24)||U/L||Standard Deviation|Mean
104766|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Absolute Neutrophils)||percentage of patients|||Number
104767|NCT00774397|Secondary|Change From Baseline to Week 24 in Absolute Neutrophils of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24)||GI/L||Standard Deviation|Mean
104768|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Haemoglobin)||percentage of patients|||Number
104769|NCT00774397|Secondary|Change From Baseline to Week 24 in Haemoglobin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Haemoglobin at Week 24)||g/dL||Standard Deviation|Mean
104770|NCT00774397|Secondary|Global Assessment of Tolerability|"The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation.~Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'."|Week 24|Per protocol set||percentage of patients|||Number
104807|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported||Day 0 through 6 weeks after Day 0|||days with symptom reported|Days of observation||Number
104774|NCT00774397|Secondary|Relapse|"Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection.~Patients could experience relapse at any point post-treatment."|post-End of treatment (i.e. post 48 weeks)|Per protocol set||percentage of patients|||Number
104775|NCT00774397|Secondary|Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)|Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.|Week 24 through Week 48|Per protocol set||percentage of patients|||Number
104776|NCT00774397|Secondary|Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)|Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.|Up to Week 24|Per protocol set||percentage of patients|||Number
104777|NCT00774397|Secondary|Virological Rebound|"Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection.~Note that this is numerical rebound, not requiring confirmation with a re-measurement."|Week 24 or Week 48|Per protocol set||percentage of patients|||Number
104778|NCT00774397|Secondary|Time to Loss of Virological Response|"Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero.~Time is expressed in Median number of days."|Week 24|Per protocol set||Number of days||95% Confidence Interval|Median
104779|NCT00774397|Secondary|Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection|Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)|On or after day 155 post end of all treatment|Per protocol set||Days||Full Range|Median
104780|NCT00774397|Secondary|Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy|Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60|Week 36 or Week 60|Per protocol set||percentage of patients|||Number
104781|NCT00774397|Secondary|End of Treatment Response at End of All Therapy|End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48|Week 24 or Week 48|Per protocol set||percentage of patients|||Number
104782|NCT00774397|Secondary|End of Treatment Response at Week 24|End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.|Week 24|Per protocol set||percentage of patients|||Number
104783|NCT00774397|Secondary|Complete Early Virological Response (cEVR)|Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12|Week 12|Per protocol set||percentage of patients|||Number
104784|NCT00774397|Secondary|Extended Rapid Virological Response (eRVR)|Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12|Week 4 and Week 12|Per protocol set||percentage of patients|||Number
104785|NCT00774397|Secondary|Early Virological Response (EVR)|Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12|Baseline and Week 12|Per protocol set||percentage of patients|||Number
104786|NCT00774397|Secondary|Virological Response at Week 4|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)|Week 4|Per protocol set||percentage of patients|||Number
104787|NCT00774397|Secondary|Virological Response at Week 2|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)|Week 2|Per protocol set||percentage of patients|||Number
104788|NCT00774397|Primary|Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy|"Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection.~The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24.~Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved."|Day 155 after the end of all treatment|Per protocol set||percentage of patients||95% Confidence Interval|Number
104789|NCT00774397|Primary|Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo|"An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD).~This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48.~The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'."|Week 28|"Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations .~FAS was composed of all randomised patients who took at least 1 dose of study medication.~For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated."||percentage of patients|||Number
104790|NCT00774306|Secondary|Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)||8 weeks, 16 weeks||||||
104791|NCT00774306|Primary|Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms||8 weeks, 16 weeks||||||
104792|NCT00774267|Primary|Percent Change From Baseline in Mammographic Breast Density at Month 24|The digitized mammogram pairs were analyzed by a single trained radiologist who determined the density of the breast using software. The only left craniocaudal view was used for assessing breast density.|primary study baseline, Month 24|All available participants were analyzed. Here, ‘N’ (number of participants analyzed) signifies those participants who had technically acceptable mammograms available at primary study baseline and Month 24.||percent change||Standard Deviation|Mean
104809|NCT00774163|Primary|Number of Participants With a Positive Blood Culture for L. Reuteri|To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).|participants were followed for an average of 36 days|2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol||participants|||Number
104810|NCT00774046|Secondary|Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 883 days|Subset of patients undergoing autologous stem cell transplant||Days||Full Range|Median
104811|NCT00774046|Secondary|Overall Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 817 days|Subset of patients undergoing autologous stem cell transplant||Days||Full Range|Median
104812|NCT00774046|Secondary|Numbers of Stem Cells Collected||1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.||10^6 CD34+ cells/kg||Full Range|Median
104813|NCT00774046|Secondary|Feasibility of Stem Cell Collection|Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg|1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.||percentage of participants||95% Confidence Interval|Number
104814|NCT00774046|Primary|Relapse-free Survival|Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.|Up to 2000 days|||Days||Inter-Quartile Range|Median
104815|NCT00774046|Primary|Overall Survival||Up to 2000 days|||Days||Inter-Quartile Range|Median
104816|NCT00774046|Primary|Response to Induction Chemotherapy (CR or PR)|Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made|Day 28-40|||percentage of participants||95% Confidence Interval|Number
104817|NCT00773968|Secondary|Percentage of Participants Who Required Red Blood Cell Transfusions||Weeks 1 to 28|Safety population.||percentage of participants|||Number
104818|NCT00773968|Secondary|Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP|The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP: Weeks 1 to 16; EEP: Weeks 17 to 28|Per protocol population.||percentage of participants|||Number
104819|NCT00773968|Secondary|Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP||EEP: Weeks 17 to 28|Per protocol population.||days||Full Range|Median
104820|NCT00773968|Secondary|Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP||EEP: Weeks 17 to 28|Per protocol population.||percentage of participants||95% Confidence Interval|Number
104821|NCT00773968|Secondary|Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)|Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.|SVP: Week -4 to Week 0; EEP: Weeks 17 to 28|Per protocol population.||g/dL||Standard Deviation|Mean
104822|NCT00773968|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)|The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).|EEP: Weeks 17 to 28|Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation.||percentage of participants||95% Confidence Interval|Number
104823|NCT00773955|Secondary|Duration of Response||From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years|There were no confirmed responses qualifying for this endpoint.|||||
104824|NCT00773955|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier.~Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From registration to the earliest date documentation of disease progression, assessed up to 5 years|All 15 patients were analyzed for this endpoint.||months||95% Confidence Interval|Median
104825|NCT00773955|Secondary|Survival Time|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|All 15 patients were analyzed for this endpoint.||months||95% Confidence Interval|Median
104826|NCT00773955|Primary|Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)|"The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:~A Complete Response (CR) requires the disappearance of all target lesions~A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements."|During the first 6 courses of treatment|One patient discontinued therapy after one cycle of treatment due to persistent grade 1 thrombocytopenia. Therefore, fourteen patients were evaluable for the primary end point at the interim analysis.||participants|||Number
104830|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104831|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104832|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 24|ITT; Participants who entered the extension period||percentage of participants||95% Confidence Interval|Number
104833|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104834|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
104835|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
104843|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 36|Intent to Treat; Includes participants who entered the long term extension period||units on a scale||Standard Deviation|Mean
104836|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
104837|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long-term extension study||units on a scale||Standard Deviation|Mean
104838|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
104839|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension study||units on a scale||Standard Deviation|Mean
104840|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period||units on a scale||Standard Deviation|Mean
104841|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long term extension period||units on a scale||Standard Deviation|Mean
104842|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 48|Intent to Treat; Includes participants who entered the long term extension study||units on a scale||Standard Deviation|Mean
104844|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 24|Intent to Treat; Includes participants who entered the long term extension study||units on a scale||Standard Deviation|Mean
104845|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 18|Intent to Treat; Includes participants who entered the long term extension period||units on a scale||Standard Deviation|Mean
104846|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|Intent to Treat; participants who entered into the LTE period||percent change||Full Range|Median
104847|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|Intent to Treat; participants who entered into the long-term extension period||percent change||Full Range|Median
104848|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|Intent to Treat; participants who entered into the LTE period||percent change||Full Range|Median
104849|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; participants who entered into the LTE period||percent change||Full Range|Median
104850|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|ITT; participants who entered the long-term extension period||percent change||Standard Deviation|Mean
104851|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|ITT; participants who entered the long-term extension period||percent change||Standard Deviation|Mean
104852|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|ITT; participants who entered the long-term extension period||percent change||Standard Deviation|Mean
104853|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percent change||Standard Deviation|Mean
104854|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 196|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.|||||
104908|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
104855|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 4 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
104856|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 3 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
104857|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 2 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 24|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
104858|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 18 Months|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percent change||Standard Deviation|Mean
104859|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years|PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
104860|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104861|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104862|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104863|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104864|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104865|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104866|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104867|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104868|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104869|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period||percentage of participants||95% Confidence Interval|Number
104870|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; participants who entered the long-term extension study||percentage of participants||95% Confidence Interval|Number
104871|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; participants who entered the long-term extension study||percentage of participants||95% Confidence Interval|Number
104872|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks|Safety population: includes all participants who were treated with Apremilast||participants|||Number
104873|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase|For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI-90 was not defined or analyzed as there were too few such participants.|||||
104874|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase|For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.|Weeks 0 to 16|Includes PASI-75 responders during the placebo controlled phase.||weeks||Full Range|Median
104875|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase|For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to 16|Includes PASI-50 responders during the placebo controlled phase||weeks||Full Range|Median
104876|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0-88; up to data cut off of 21 July 2011|Includes all participants who were treated with Apremilast||participants|||Number
104953|NCT00773461|Secondary|Percentage of Participants With ACR20 Response by First Week of Onset|ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||Percentage of Participants|||Number
104877|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16; up to data cut off of 21 July 2011|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)||participants|||Number
104878|NCT00773734|Secondary|Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)|Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.|Up to 4 weeks after the last dose|Participants who entered the observational follow-up phase and were PASI-50 responders at the beginning of the time interval.||weeks||95% Confidence Interval|Median
104879|NCT00773734|Secondary|Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.|Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study|Week 0 to 52|This endpoint was not summarized since the time of the maximal improvement is variable and the maximal improvement could occur in either the core phase or the extension phase|||||
104880|NCT00773734|Secondary|Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52|Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0|Week 0 to Week 52|The dose-response relationship analysis was anticipated, however, since the extension study was optional and there was not placebo control, no formal testing of dose response was conducted|||||
104881|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value..|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat||units on a scale||Standard Deviation|Mean
104882|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat;||units on a scale||Standard Deviation|Mean
104883|NCT00773734|Secondary|Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
104939|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
104884|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
104885|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat||units on a scale||Standard Deviation|Mean
104886|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat||units on a scale||Standard Deviation|Mean
104887|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 52|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
104888|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 40|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat||units on a scale||Standard Deviation|Mean
104889|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 32|Includes participants who entered the extension study and had DLQI assessment at Week 32; Intent to Treat||units on a scale||Standard Deviation|Mean
104890|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 52|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 52|Includes participants who entered the extension study and had BSA assessment at Week 52; Intent to Treat;||percent change||Standard Deviation|Mean
104891|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 40|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 40|Includes participants who entered the extension study and had BSA assessment at Week 40; Intent to Treat||percent change||Standard Deviation|Mean
104892|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 32|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 32|Includes participants who entered the extension study and had a BSA assessment at Week 32; Intent to Treat||percent change||Standard Deviation|Mean
104893|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 52|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.|||||
104894|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 40|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.|||||
104895|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 32|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.|||||
104896|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 52|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 52|Includes participants who entered the extension study and had PASI assessment at Week 52; Intent to Treat;||percent change||Standard Deviation|Mean
104897|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 40|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 40|Includes participants who entered the extension study and had PASI assessment at Week 40; Intent to Treat;||percent change||Standard Deviation|Mean
104898|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 32|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 32|Includes participants who entered the extension study and had PASI assessment at Week 32; Intent to Treat||percent change||Standard Deviation|Mean
104954|NCT00773461|Secondary|Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24|HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and 24 Weeks|ITT Population||units on a scale||Standard Deviation|Mean
104899|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.||percentage of participants||95% Confidence Interval|Number
104900|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat||percentage of participants||95% Confidence Interval|Number
104901|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat||percentage of participants||95% Confidence Interval|Number
104902|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-100 During the Extension Study|For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.|Week 0 to Extension Study|Time to achieve PASI-100 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
104903|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-90 During the Extension Study|For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.|Week 0 to Extension study|Time to achieve PASI-90 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
104904|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-50 During the Extension Study|For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to Week 52|Time to achieve PASI-50 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
104905|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-75 During the Extension Study|For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.|Week 0 to Week 52|Time to achieve PASI-75 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study|||||
104906|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
104907|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
104909|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104910|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104911|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104912|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104913|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104914|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104940|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The PASI 100 was not defined and analyzed since there were too few such participants.|||||
104915|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104916|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation||percentage of participants||95% Confidence Interval|Number
104917|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.||percentage of participants||95% Confidence Interval|Number
104918|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||hours||Full Range|Median
104919|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||hours||Full Range|Median
104920|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
104921|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||ng/mL||Geometric Coefficient of Variation|Geometric Mean
104922|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
104923|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
104924|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||units on a scale||Standard Deviation|Mean
104955|NCT00773461|Secondary|Change in Hemoglobin From Baseline to Week 24|Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants|Baseline and 24 Weeks|ITT Population||g/L||Standard Deviation|Mean
104956|NCT00773461|Secondary|Mean Rheumatoid Factor at Baseline and Week 24|Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL.|Baseline and 24 Weeks|ITT Population||IU/mL||Standard Deviation|Mean
104925|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||units on a scale||Standard Deviation|Mean
104926|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||units on a scale||Standard Error|Least Squares Mean
104927|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||units on a scale||Standard Error|Least Squares Mean
104928|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||units on a scale||Standard Deviation|Mean
104929|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||units on a scale||Standard Error|Least Squares Mean
104930|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percent change||Standard Deviation|Mean
104931|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percent change||Standard Error|Least Squares Mean
104941|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
104932|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 24|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.|||||
104933|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 16|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See other pre-specified outcome measures.|||||
104934|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
104935|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Week 16|Intent to Treat; Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
104936|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 24|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percent change||Standard Deviation|Mean
104937|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 16|The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||Percent change||Standard Error|Least Squares Mean
104938|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase|For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI 100 was not defined or analyzed as there were too few participants.|||||
104942|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
104943|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
104944|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
104945|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; End of Period = Last observation carried forward in the period||percentage of participants||95% Confidence Interval|Number
104946|NCT00773734|Primary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 and Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values||percentage of participants|||Number
104947|NCT00773474|Secondary|Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).||18 months|20 evaluable subjects were analyzed for Clinical Benefit Rate (CR+PR+SD>180 days per RECIST criteria.||participants|||Number
104948|NCT00773474|Secondary|Toxicity Profile of Lonafarib|To determine the toxicity profile of lonafarnib in this patient population.|18 months|||participants|||Number
104949|NCT00773474|Secondary|Overall Response Rate|To determine overall response rate.|18 months|17 participants were evaluable for Overall Response Rate analysis using RECIST criteria.||participants|||Number
104950|NCT00773474|Primary|Progression Free Survival|To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.|18 months|20 participants were eligible for analysis via the Kaplan-Meier method. PFS assessed via RECIST criteria.||days||95% Confidence Interval|Mean
104951|NCT00773461|Secondary|Time to First Remission|Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS<2.6|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||Days||95% Confidence Interval|Median
104952|NCT00773461|Secondary|Time to First Low Disease Activity|Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population||Days||95% Confidence Interval|Median
104957|NCT00773461|Secondary|Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in health status.|Baseline and Week 24|ITT Population||units on a scale||Standard Deviation|Mean
104958|NCT00773461|Secondary|Percentage of Participants With Low Disease Activity and in Clinical Remission|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants analyzed.||Percentage of Participants|||Number
104959|NCT00773461|Secondary|Change in ESR From Baseline to Week 24|The ESR was measured in mm/hour. A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population||mm/hour||Standard Deviation|Mean
104960|NCT00773461|Secondary|Change in C-Reactive Protein From Baseline to Week 24|The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population||mg/dL||Standard Deviation|Mean
104961|NCT00773461|Secondary|Change in Participant's Global Assessment of Pain From Baseline to Week 24|The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
104962|NCT00773461|Secondary|Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity).|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
104963|NCT00773461|Secondary|Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24|The participant’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline and Week 24|ITT Population||mm||Standard Deviation|Mean
104964|NCT00773461|Secondary|Change in Tender and Swollen Joint Counts From Baseline to Week 24|"68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.~66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66."|Baseline and Week 24|ITT Population||Joints||Standard Deviation|Mean
104965|NCT00773461|Secondary|Number of Participants Who Received Escape Therapy|Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD.|24 Weeks|ITT Population||Number of participants|||Number
104966|NCT00773461|Secondary|Percentage of Participants With ACR50 and ACR70 Responses at Week 24|To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted.|Week 24|ITT Population||Percentage of Participants|||Number
104967|NCT00773461|Primary|Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24|To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward [LOCF]).|Week 24|ITT Population||Percentage of Participants|||Number
104968|NCT00773383|Secondary|Assessment of Potential Predictive and Prognostic Biomarkers.|Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial.|Throughout study|Responders and non-responders|||||
104969|NCT00773383|Secondary|Population Pharmacokinetics of R1507 and Tarceva|Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial.|Throughout study|Population PK of R1507 and erlotinib|||||
104970|NCT00773383|Secondary|Electrocardiogram (ECG)|12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided).|baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks)|Safety Population||ms (millisecond)||Standard Deviation|Mean
104971|NCT00773383|Secondary|Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing|"Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity.~To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with > 19.7% inhibition were considered true positives, whereas those with < 19.7% inhibition were considered to be false positives."|prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks)|Safety Population||participants|||Number
104972|NCT00773383|Secondary|Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|Within 7 days of starting treatment (baseline visit)|Female patients of childbearing potential|||||
104973|NCT00773383|Secondary|Hemoglobin A1c (HbA1c)|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|screening|Safety Population|||||
104974|NCT00773383|Secondary|Fasting Glucose, Highest Post-Baseline Value|A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant’s baseline glucose level is reported.|Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks)|Safety Population: based on the total number of participants n = 34||participants|||Number
104975|NCT00773383|Secondary|Baseline Electrocardiogram (ECG)|"Standard safety monitoring includes baseline Electrocardiogram (ECG).~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|baseline within 28 days of starting treatment (screening visit).|Safety Population|||||
104976|NCT00773383|Secondary|Duration of Objective Response|This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken|All Treated Population|||||
104977|NCT00773383|Secondary|Time to Progressive Disease (PD)|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.|All Treated Population|||||
104978|NCT00773383|Secondary|Time to Best Response|"This is defined as time from the start of therapy to the date of first CR or PR.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population|||||
104979|NCT00773383|Secondary|Participants Achieving Objective Response|"Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population|||||
104980|NCT00773383|Secondary|Duration of Overall Survival|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of treatment to death; up to the time that all participants ended treatment|All Treated Population|||||
104981|NCT00773383|Primary|Percentage of Participants With Progression Free Survival (PFS)|The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.|12 weeks|All Treated Population||Percentage of participants|||Number
104982|NCT00773370|Secondary|Stroke Impact Scale (SIS)|The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.||units on a scale||Standard Error|Mean
105007|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Age.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
104983|NCT00773370|Secondary|Short Physical Performance Battery (SPPB)|The SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
104984|NCT00773370|Secondary|Balance as Measured by the Berg Balance Scale (BBS)|The Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|||units on a scale||Standard Error|Mean
104985|NCT00773370|Primary|6 Minute Walk Test (6MWT)|Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|||meters||Standard Error|Mean
104986|NCT00773253|Primary|Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale|Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).|48 weeks|All participants that completed all phases of the study||percent change in units on the scale||Standard Deviation|Mean
104987|NCT00773253|Primary|Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)||pre-injection, week 16, 20, 36, and 40||||||
104988|NCT00773136|Primary|Efficacy of Bimatoprost in Lengthening of Eyelashes|Eyelash growth after application of bimatoprost vs control (split face study).|4.5 months (6 weeks of drug application and 3 months after discontinuing)|||mm||Standard Deviation|Mean
104989|NCT00773097|Secondary|Number of Participants With Adverse Events Associated With the Study Agent|Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.|54 weeks|||participants|||Number
104990|NCT00773097|Secondary|Number of Participants With Autoimmune Response to Muc-1 Vaccine|Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.|52 weeks|||participants|||Number
104991|NCT00773097|Primary|Number of Participants With Anti Muc-1 Antibody|Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.|52 weeks|Of the 46 subjects who consented to participate, 6 did not receive vaccine: 4 had abnormal screening laboratory test, 1 did not meet criteria for an advanced adenoma, and 1 declined to participate||participants|||Number
104992|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
104993|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
104994|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
104995|NCT00772967|Primary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation||units on a scale||95% Confidence Interval|Least Squares Mean
104996|NCT00772954|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.||Day 0 up to 70 days post first vaccination|Safety assessments were on the safety population.||Participants|||Number
104997|NCT00772941|Secondary|Number of Participants With Continuous Abstinence Situation by 52 Weeks.|Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.|52 weeks|No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.||participants|||Number
104998|NCT00772941|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of unlisted treatment related adverse events.||events|||Number
104999|NCT00772941|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of treatment related adverse events.||participants|||Number
105000|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.||participants|||Number
105001|NCT00772941|Primary|Risk Factors for the Proportion of Responders – Prolonged Administration After 12 Weeks.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.||participants|||Number
105002|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.||participants|||Number
105003|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.|Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.||participants|||Number
105004|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Therapies.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
105005|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Drugs.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
105006|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
105008|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Gender.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
105009|NCT00772928|Other Pre-specified|Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™|Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.|0-3 days post- vaccination and entire study period|Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.||Percentage of Participants|||Number
105010|NCT00772928|Primary|Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.|60 Days Post-dose 3|Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population||All Units||95% Confidence Interval|Geometric Mean
105011|NCT00772928|Primary|Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.|28 to 48 days post-3rd vaccination|Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.||Percentage of Participants|||Number
105012|NCT00772915|Secondary|Adverse Events||Duration on treatment (up to 18 cycles from registration)||||||
105013|NCT00772915|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.~Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|Time from registration to progression or death (up to 3 years)||||||
105014|NCT00772915|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method|Time from registration to death (up to 3 years)||||||
105015|NCT00772915|Secondary|Overall Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Up to 18 cycles from registration||||||
105016|NCT00772915|Primary|Progression-free Survival Rate at 12 Months|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of registration.|12 months from registration|||participants|||Number
105017|NCT00772889|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 21-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
105018|NCT00772889|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available.||fold increase||95% Confidence Interval|Mean
105019|NCT00772889|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||subjects|||Number
105020|NCT00772889|Secondary|The Number of Subjects Seroprotected by HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||subjects|||Number
105021|NCT00772889|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||subjects|||Number
105022|NCT00772889|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||titer||95% Confidence Interval|Geometric Mean
105023|NCT00772889|Secondary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-364.|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
105024|NCT00772889|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
105025|NCT00772889|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
105026|NCT00772889|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
105027|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
105028|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
105029|NCT00772889|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
105030|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
105031|NCT00772889|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
105032|NCT00772889|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
105033|NCT00772772|Secondary|1, 25-OH Vitamin D||after 8 weeks of vitamin D therapy||||||
105034|NCT00772772|Secondary|25-hydroxy Vitamin D (25-OH Vitamin D)|25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.|after 8 weeks of vitamin D therapy|Patients with chronic kidney disease had 25-OH vitamin D levels measured at baseline and after 8 weeks of Vitamin D3 therapy. Analysis was per protocol.||ng/ml||Standard Error|Mean
105035|NCT00772772|Secondary|Nuclear Magnetic Resonance (NMR) Lipoprotein Profile||after 8 weeks of vitamin D therapy||||||
105036|NCT00772772|Secondary|Intestinal Permeability||after 8 weeks of vitamin D therapy||||||
105037|NCT00772772|Secondary|Blood Pressure||after 8 weeks of vitamin D therapy||||||
105038|NCT00772772|Primary|Change in Endotoxin Activity|Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).|baseline and 8 weeks|Per protocol. Result is expressed as change in endotoxin activity with therapy||EA units||Standard Deviation|Mean
105039|NCT00772707|Primary|Comfort Ratings at 30 Days|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|30 days|5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).||Percentage of Participants|||Number
105040|NCT00772707|Primary|Comfort Ratings at Baseline|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|Baseline (Day 0)|6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).||Percentage of Participants|||Number
105041|NCT00772668|Secondary|Safety and Tolerance to Rituximab, Cyclophosphamide, Bortezomib, and Prednisone||5 years||||||
105042|NCT00772668|Secondary|Overall Survival||5 years||||||
105043|NCT00772668|Secondary|Progression-free Survival as Assessed by RECIST Criteria||5 years||||||
105044|NCT00772668|Primary|Overall Response Rate, According to the International Workshop Criteria (IWC)||5 years||||||
105045|NCT00772629|Primary|Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.|Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.|Day 28 post-vaccination|SBA-BR to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Participants|||Number
105046|NCT00772603|Secondary|Seizure Free Rate, ITT, (M)|Percent of patients seizure-free during Maintenance, Intent-to-Treat population|At the end of 12 weeks (Maintenance Period)|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.||percentage of patients|||Number
105047|NCT00772603|Secondary|Seizure-Free Rates, ITT|Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.||percentage of patients|||Number
105048|NCT00772603|Secondary|Responder Rate, ITT|Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.||percentage of patients|||Number
105049|NCT00772603|Secondary|PCH(M)- ITT|Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population|Change at 12 weeks (Maintenance Period) compared to Baseline|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.||percentage of change||95% Confidence Interval|Median
105050|NCT00772603|Primary|PCH(T), ITT|Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.|Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.||percentage of change||Full Range|Median
105051|NCT00772590|Primary|Mean Change From Baseline CD4+ Cell Count|Comparison of normalised mean change from baseline CD4+ cell count|24 weeks|intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.||Cells/microlitre||Standard Deviation|Mean
105052|NCT00772577|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP)|To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
105053|NCT00772577|Secondary|Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)|To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).||Percentage of patients|||Number
105067|NCT00772538|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.||Participants|||Number
105054|NCT00772577|Secondary|Percentage of Patients Achieving Blood Pressure Control During 8 Weeks|The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).||Percentage of patients|||Number
105055|NCT00772577|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
105056|NCT00772577|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
105057|NCT00772538|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.417 (NCT00776984) and the Present 205.416 (NCT00772538)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)||percentage of participants|||Number
105058|NCT00772538|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Puffs||Standard Error|Mean
105059|NCT00772538|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Days||Standard Error|Mean
105060|NCT00772538|Secondary|ACQ at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
105061|NCT00772538|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
105062|NCT00772538|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
105063|NCT00772538|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.||Scores on a scale||Standard Error|Mean
105064|NCT00772538|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
105065|NCT00772538|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.||Participants|||Number
105066|NCT00772538|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As <50percent (10 of 222 patients in the placebo group and 8 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
105068|NCT00772538|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.||Participants|||Number
105069|NCT00772538|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS..||Participants|||Number
105070|NCT00772538|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS..||Participants|||Number
105071|NCT00772538|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As <50percent (68 of 222 patients in the placebo group and 53 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||||
105072|NCT00772538|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Percent||Standard Error|Mean
105073|NCT00772538|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
105074|NCT00772538|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||Liter||Standard Error|Mean
105075|NCT00772538|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
105076|NCT00772538|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.||L/min||Standard Error|Mean
105077|NCT00772538|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
105078|NCT00772538|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
105079|NCT00772538|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
105080|NCT00772538|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
105081|NCT00772538|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
105082|NCT00772538|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.||Liter||Standard Error|Mean
105083|NCT00772538|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
105084|NCT00772538|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
105085|NCT00772538|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
105086|NCT00772538|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
105087|NCT00772538|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||Days||Inter-Quartile Range|Median
105088|NCT00772538|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.||Liter||Standard Error|Mean
105089|NCT00772538|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.||Liter||Standard Error|Mean
105090|NCT00772447|Secondary|Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC|This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 48 patients indentified staphylococcus aureus infection both in daptomycin group and in comparator group.||Percentage of patients|||Number
105091|NCT00772447|Secondary|Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC|This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 33 patients indentified MSSA infection in daptomycin group and 37 patients indentified with MSSA in comparator group.||Percentage of patients|||Number
105092|NCT00772447|Secondary|Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)|This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.|baseline and TOC, for up to 4 weeks|There were 14 patients indentified MRSA infection in daptomycin group and 10 patients indentified with MRSA in comparator group.||Percentage of patients|||Number
105093|NCT00772447|Secondary|Microbiological Response at EOT(End of Therapy)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.|baseline and EOT, for up to 2 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 86 strains isolated from 81 patients in daptomycin arm and 88 strains from 81 patients in comparator arm who met the criteria of ME population at EOT visit.||Percentage of strains|Participants||Number
105094|NCT00772447|Secondary|Microbiological Response at TOC(Test of Cure)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.|baseline and TOC, for up to 4 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 83 strains isolated from ME population of daptomycin arm(78 patients) and 86 strains from ME population in comparator arm(79 patients).||Percentage of strains|Participants||Number
105095|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and EOT(end of therapy), for up to 2 weeks|There were 110 patients in daptomycin arm and 103 patients in comparator arm who both completed EOT visit and met the criteria of CE population||Percentage of patients|||Number
105096|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and TOC, for up to 4 weeks|There were 107 patients in daptomycin arm and 101 patients in comparator arm meeting the criteria of CE population and completed TOC visit.||percentage of patients|||Number
105097|NCT00772447|Primary|Shift in ECG|percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had both measurements at baseline and TOC visit and those who got normal ECG resluts at baseline were included in the summary. Change=TOC visit-baseline||percentage of patients|||Number
105098|NCT00772447|Primary|Change in Urine pH||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements were included in the summary of a specific parameter at a specific time point. Change = TOC visit - baseline||pH||Standard Deviation|Mean
105099|NCT00772447|Primary|Change in Serum Total Creatine Phosphokinase (CPK)||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline||IU/L||Standard Deviation|Mean
105100|NCT00772447|Primary|Change in Creatinine Clearance||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline||ml/min||Standard Deviation|Mean
105101|NCT00772447|Primary|Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)|Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline||percentage||Standard Deviation|Mean
105102|NCT00772382|Secondary|The Change in Serum Phosphorus From Baseline to Week 52||52 weeks|Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.)||mg/dL||95% Confidence Interval|Mean
105103|NCT00772382|Primary|Number of Adverse Events (AE)||52 weeks|||participants|||Number
105687|NCT00768651|Primary|HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy|HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.|6 months||||||
105104|NCT00772369|Primary|Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.|"SAE: any untoward medical occurrence with the following outcomes:~death,~a life-threatening adverse drug experience (as confirmed by the investigators),~inpatient hospitalization or prolongation of existing hospitalization,~a persistent or significant disability/incapacity, or~a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)"|6 Months post 4th dose vaccination|Response to questionnaire that were confirmed by the primary care physician’s office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis.||Participants|||Number
105105|NCT00772369|Primary|Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series|"Positive response is a 'Yes' to any of the following questions:~Has your child been admitted to a hospital?~Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician’s office?~Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?~Has your child been diagnosed by a physician as having:~Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?"|6 months post 4th dose vaccination|Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.||Particpants|||Number
105106|NCT00772304|Secondary|Taste and Aftertaste of Medication||5 min, 45 min.||||||
105107|NCT00772304|Primary|Product Preference Questionnaire for Immediate Taste|Using a set of coded responses, subjects evaluated product preference in regards to immediate taste|5 min post-dose|||Percentage of participants|||Number
105108|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|14 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.||percentage of patients|||Number
105109|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|7 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.||percentage of patients|||Number
105110|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|1 day|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.||percentage of patients|||Number
105111|NCT00772148|Primary|Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)||ng/mL*hr||Standard Deviation|Mean
105112|NCT00772148|Secondary|Number of Participants Who Died Within the 360 Days.|Number of patients who died was compared between the two groups during the study.|360 days|||participants|||Number
105113|NCT00772148|Primary|Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)||ng/mL||Standard Deviation|Mean
105114|NCT00772109|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to 7 Days post vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population||Participants|||Number
105115|NCT00772109|Secondary|Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroprotection was defined as a HAI antibody titer ≥ 1:40."|Before and 28 Days post-vaccination|4-Fold increase in antibody levels were analyzed in h per-protocol population||Percentage of Participants|||Number
105116|NCT00772109|Primary|Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination."|28 Days post-vaccination|Seroprotection was analyzed in the per-protocol population||Percentage of Participants|||Number
105117|NCT00772109|Primary|Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines|The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay|Baseline (Day 0) and 28 Days post-vaccination|Geometric Mean Titers (GMTs) were analyzed in the per-protocol population||Titer||95% Confidence Interval|Geometric Mean
105118|NCT00772070|Primary|Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.||Day 0 and Days 8 and 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
110640|NCT00728754|Secondary|Osseous Integration||four years||||||
105119|NCT00772070|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.||Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Percentage of participants|||Number
105120|NCT00772070|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.||Baseline to Day 8 and Day 28 post-vaccination|Fold rise analysis was assessed in per-protocol population with valid serology data.||Percentage of participants|||Number
105121|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 Months|||units on a scale||Standard Deviation|Mean
105122|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
105123|NCT00772031|Secondary|Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|baseline and 6 months post randomization|per protocol||units on a scale||Standard Deviation|Mean
105124|NCT00772031|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months|MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).|Baseline and 6 months|per protocol||units on a scale||Standard Deviation|Mean
105125|NCT00772031|Secondary|Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months|Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).|Baseline and 6 months|The number who completed the Beck's Depression Inventory at baseline and three months||units on a scale||Standard Deviation|Mean
105126|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days||6 months|All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months||participants|||Number
105127|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days||6 months post randomization|All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure||participants|||Number
105128|NCT00772031|Primary|Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline|(Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).|Baseline (pre-randomization), months 5 and 6 post randomization|ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome.||Moderate to severe headache days||Standard Deviation|Mean
105129|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105130|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105331|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.||percentage of participants|||Number
105131|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105132|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105133|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105134|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105135|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105136|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105137|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105138|NCT00772005|Secondary|Change From Baseline to Week 24 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Awakenings||Standard Deviation|Mean
105139|NCT00772005|Secondary|Change From Baseline to Week 12 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Awakenings||Standard Deviation|Mean
105312|NCT00771810|Secondary|Rescue Treatment for Hematopoiesis and Mucositis|"Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:~Transfusions~Filgrastim or Pegfilgrastim~Erythropoietin~Palifermin"|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
105140|NCT00772005|Secondary|Change From Baseline to Endpoint in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Awakenings||Standard Deviation|Mean
105141|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105142|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105143|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Minutes||Standard Deviation|Mean
105144|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
105145|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.||percentage of participants|||Number
105146|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
105147|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
105148|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
105313|NCT00771810|Secondary|Alopecia|Number of subjects with a treatment emergent adverse event of alopecia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
105149|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
105150|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
105151|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.||Percentage of participants|||Number
105152|NCT00772005|Secondary|Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105153|NCT00772005|Secondary|Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105154|NCT00772005|Secondary|Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105155|NCT00772005|Secondary|Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105156|NCT00772005|Secondary|Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105157|NCT00772005|Secondary|Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105158|NCT00772005|Secondary|Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105159|NCT00772005|Secondary|Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105160|NCT00772005|Secondary|Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105161|NCT00772005|Secondary|Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105162|NCT00772005|Secondary|Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105163|NCT00772005|Secondary|Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105164|NCT00772005|Secondary|Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105165|NCT00772005|Secondary|Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105314|NCT00771810|Secondary|Mucositis|Number of subjects with a treatment emergent adverse event of mucositis|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
105315|NCT00771810|Secondary|Anemia|Number of subjects with a treatment emergent adverse event of anemia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
110732|NCT00726622|Secondary|Local Pelvic Recurrence Rates||Up to 2 years post surgery||||||
105166|NCT00772005|Secondary|Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105167|NCT00772005|Secondary|Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105168|NCT00772005|Secondary|Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105169|NCT00772005|Secondary|Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105170|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105171|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105172|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105173|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105316|NCT00771810|Secondary|Neutropenia|Number of subjects with a treatment emergent adverse event of neutropenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
105317|NCT00771810|Secondary|Lymphopenia as Determined by Lymphocyte Count|Number of subjects with a treatment emergent adverse event of lymphopenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
105174|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105175|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105176|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105177|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105178|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105179|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 24, positive value represents worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105180|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 20, positive value represents worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105181|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 16, positive value represents worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105182|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 12, positive value represents worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105183|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 8, positive value represents worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105184|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 4, positive value represents worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105185|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 2, positive value represents worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105186|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 1, positive value represents worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105187|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Deviation|Mean
105188|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses||Standard Error|Least Squares Mean
105189|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses||Standard Error|Least Squares Mean
105190|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses||Standard Error|Least Squares Mean
105191|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses minus errors||Standard Error|Least Squares Mean
110733|NCT00726622|Secondary|Disease-free Survival||Up to 2 years post surgery||||||
105192|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses minus errors||Standard Error|Least Squares Mean
105193|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Correct responses minue errors||Standard Error|Least Squares Mean
105194|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Number of correct responses||Standard Error|Least Squares Mean
105195|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Number of correct responses||Standard Error|Least Squares Mean
105196|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Number of correct responses||Standard Error|Least Squares Mean
105197|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 24, with positive score showing improvement."|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105198|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 12, with positive score showing improvement."|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105199|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement."|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105318|NCT00771810|Secondary|Chemotherapy Dose Intensity and Dose Density|Mean percentage of cycles where projected (target) chemotherapy dose was maintained|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.||Percentage of cycles||Full Range|Mean
105688|NCT00768651|Primary|Change From Baseline on Gastrin Level After One Month of Therapy|Gastrin levels were measured at baseline and at one month by method (manufacturer).|Baseline and One month||||||
105200|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105201|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105202|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105203|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105204|NCT00772005|Secondary|Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105205|NCT00772005|Secondary|Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 22|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105206|NCT00772005|Secondary|Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105207|NCT00772005|Secondary|Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 18|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105319|NCT00771810|Secondary|Treatment Cycles With Platelets Counts Below 25,000/mm3|Mean percentage of treatment cycles where platelets counts were below 25,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.||Percentage of cycles||Full Range|Mean
105320|NCT00771810|Secondary|Subjects With Platelet Counts Below 50,000/mm3|Number of subjects who experienced a platelet count below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.||Participants|||Number
105208|NCT00772005|Secondary|Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105209|NCT00772005|Secondary|Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 14|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105210|NCT00772005|Secondary|Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105211|NCT00772005|Secondary|Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 10|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105212|NCT00772005|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105213|NCT00772005|Secondary|Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 6|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105214|NCT00772005|Secondary|Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105215|NCT00772005|Secondary|Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105216|NCT00772005|Secondary|Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105217|NCT00772005|Secondary|Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105218|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105219|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105220|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105221|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105222|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105223|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105224|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105321|NCT00771810|Primary|Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3|Mean percentage of cycles with platelet counts below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.||Percentage of cycles||Full Range|Mean
106984|NCT00759811|Secondary|Improve in Heart Failure Functional Class Measured Using New York Heart Association||12 weeks||||||
105225|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105226|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105227|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105228|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105229|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105230|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105231|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105232|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105322|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Bothersome|"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal."|Day 10|Intent-to Treat population.||percent of participants|||Number
105233|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105234|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105235|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105236|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105237|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105238|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105239|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105240|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105323|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming|The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = “not at all” to 5=“a very great deal.”|Day 10|Intent-to Treat population.||percent of participants|||Number
105324|NCT00771758|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.||percenatage of participants|||Number
105241|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105242|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105243|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105244|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105245|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105246|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105247|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105248|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105325|NCT00771758|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.||percenatage of participants|||Number
105326|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.||percentage of participants|||Number
105249|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105250|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105251|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105252|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105253|NCT00772005|Secondary|Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105254|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105255|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105256|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105379|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 6|As measured by a CDAI score of < 150 points.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
105257|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105258|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105259|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105260|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105261|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105262|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105263|NCT00772005|Secondary|Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105264|NCT00772005|Secondary|Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
106127|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
105265|NCT00772005|Secondary|Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105266|NCT00772005|Secondary|Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105267|NCT00772005|Secondary|Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105268|NCT00772005|Secondary|Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105269|NCT00772005|Secondary|Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105270|NCT00772005|Secondary|Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105271|NCT00772005|Secondary|Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105272|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
107166|NCT00758459|Secondary|Forced Expiratory Flow (FEF)25−75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L/s||Full Range|Mean
105273|NCT00772005|Secondary|Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105274|NCT00772005|Secondary|Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105275|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105276|NCT00772005|Secondary|Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105277|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105278|NCT00772005|Secondary|Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105279|NCT00772005|Secondary|Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105280|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Deviation|Mean
105327|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.||percentage of participants|||Number
107167|NCT00758459|Secondary|Inspiratory Capacity (IC)|Change in IC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
105281|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105282|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105283|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105284|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105285|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105286|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105287|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105288|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105328|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.||percentage of participants|||Number
105289|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105290|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105291|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105292|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105293|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105294|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105295|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105296|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105329|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.||percentage of participants|||Number
117307|NCT00670462|Secondary|Change From Baseline in Energy Intake at 12months||12 months|||kcal/day||Standard Error|Mean
105297|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||units on a scale||Standard Error|Least Squares Mean
105298|NCT00772005|Primary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.||Units on a scale||Standard Error|Least Squares Mean
105299|NCT00771953|Primary|Progression Free Survival|For determining progression-free survival, progression was determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization until the first date that recurrent or progressive disease is objectively documented.|||days||95% Confidence Interval|Median
105300|NCT00771927|Secondary|The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population||Treatment-Emergent Adverse Events|||Number
105301|NCT00771927|Primary|The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population||Treatment-Emergent Adverse Events|||Number
105302|NCT00771914|Primary|the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment|The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.|4 hours|Each participant acted as own control since each received the intervention (placebo, aspirin, lovaza, and both aspirin and lovaza) and had these effects compared to baseline (four hour effect of each intervention).||seconds||Standard Deviation|Mean
105303|NCT00771875|Secondary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)||1 year|||participants|||Number
105304|NCT00771875|Secondary|Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy||90 days|||participants|||Number
105305|NCT00771875|Secondary|Incidence of Death||90 days|||participants|||Number
105306|NCT00771875|Secondary|Mean Serum Creatinine|Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation|7, 14, 28, 60, 90 days and 1 year post therapy initiation|||mg/dL||Standard Deviation|Mean
105307|NCT00771875|Secondary|Renal Allograft Survival||1 year after rejection treatment|||participants|||Number
105308|NCT00771875|Secondary|Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy||Day 1|||participants|||Number
105309|NCT00771875|Primary|Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection|"Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.~Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal."|1 year|||participants|||Number
105310|NCT00771849|Secondary|Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.||28 days post-vaccination|SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.||Participants|||Number
105311|NCT00771849|Primary|Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.||Day 0 (before) and 28 days post-vaccination|SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
105330|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.||percentage of participants|||Number
105332|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.||percentage of participants|||Number
105333|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.||percentage of participants|||Number
105334|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.||percentage of participants|||Number
105335|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.||percentage of participants|||Number
105336|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.||percentage of participants|||Number
105337|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.||percentage of participants|||Number
105338|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Placebo)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Placebo arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.||participants|||Number
105339|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.||participants|||Number
105340|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via Interactive Voice Response (IVR) system in the morning."|10 days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.||participants|||Number
105341|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 10|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 10|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
105342|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 5|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 5|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
105343|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 3|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 3|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
105344|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 2|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 2|Intent-to-Treat population.||Scores on a scale||Standard Deviation|Mean
105345|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study|"The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.~Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved."|Day 10|Intent-to-Treat subjects.||second||Standard Deviation|Mean
105346|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study|The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.||chair stands||Standard Deviation|Mean
105347|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study|The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.|Day 10|Intent-to-Treat subjects.||seconds||Standard Deviation|Mean
105348|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study|The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.||meters||Standard Deviation|Mean
105405|NCT00771537|Primary|Number of Participants Who Accepted Rapid HIV Testing.|Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.|During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.|||participants|||Number
105349|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.|10 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105350|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.|5 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105351|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105352|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105353|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 10 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105354|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 5 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.|5 Days (120 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105355|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 3 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105356|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 2 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105357|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 10 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105358|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 5 Days (SPID120)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.|5 Days (120 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105359|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 2 Days (SPID48)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
117552|NCT00667875|Primary|Drinks Per Drinking Day||16-week treatment period|||drinks per drinking day||Standard Deviation|Mean
105360|NCT00771758|Secondary|50% Responder Rate on Day 10.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
105361|NCT00771758|Secondary|30% Responder Rate on Day 10.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
105362|NCT00771758|Secondary|50% Responder Rate on Day 5.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
105363|NCT00771758|Secondary|30% Responder Rate on Day 5.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
105364|NCT00771758|Secondary|50% Responder Rate on Day 3.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
105365|NCT00771758|Secondary|30% Responder Rate on Day 3.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.||percentage of participants|||Number
105366|NCT00771758|Primary|Sum of Pain Intensity Difference Over 3 Days (SPID72)|"Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.~The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects."|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized patients who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.||Scores on a scale||Standard Deviation|Mean
105367|NCT00771745|Secondary|Malignancy||Undefined||||||
105368|NCT00771745|Secondary|Serum Creatinine||Post-operative days 1-7, 30, 90 and 6 months||||||
105369|NCT00771745|Secondary|Severity of Biopsy-proven Rejection Using Banff 97 Criteria||Not defined||||||
105370|NCT00771745|Secondary|Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection||Not defined||||||
105371|NCT00771745|Secondary|Incidence of Infections||Not defined||||||
105372|NCT00771745|Secondary|Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.||Ongoing||||||
105373|NCT00771745|Primary|Composite End Point of Acute Rejection, Graft Loss or Patient Death|Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death|6 months|Patients received tacrolimus (goal level 10-15 ng/mL) and mycophenolate mofetil (2gm daily) at time of transplant. Methylprednisolone (MP), acetaminophen, and diphenhydramine were given as premedication for each rATG dose (500mg MP 1st dose, 250mg MP subsequent 2 doses, 125mg MP 4th dose).||participants|||Number
105374|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
105375|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)|As measured by a CDAI score of < 150 points.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
105376|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 8|As measured by a CDAI score of < 150 points.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
105377|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 8|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
105378|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 4|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 4|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
110746|NCT00727636|Primary|Antibody Titers to HPV 16|Geometric mean titer (95% CI)|Month 7|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
105380|NCT00771667|Primary|Number of Participants With Clinical Response at Week 6|As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.||Participants|||Number
105381|NCT00771615|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
105382|NCT00771615|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.“Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 42|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
105383|NCT00771615|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
105384|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
105385|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.||Subjects|||Number
105386|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105387|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105388|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105389|NCT00771615|Secondary|Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105390|NCT00771615|Secondary|Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
105391|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||fold increase||95% Confidence Interval|Geometric Mean
105392|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105393|NCT00771615|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105394|NCT00771615|Secondary|HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
105395|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||fold increase||95% Confidence Interval|Geometric Mean
105396|NCT00771615|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
105397|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 0 to Day 42 and at Day 0 to Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105398|NCT00771615|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Titer||95% Confidence Interval|Geometric Mean
105399|NCT00771615|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105400|NCT00771615|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.||Subjects|||Number
105401|NCT00771602|Secondary|52 Week Toxicity Rate|The definition of toxicities include any >/= grade 3 non-hematologic toxicity, >/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.|52 weeks||||||
105402|NCT00771602|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.|52 weeks or until disease progression||||||
105403|NCT00771602|Primary|Number of Patients With Molecular Remissions at 52 Weeks|Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.|52 weeks|No analysis available participant ineligible for evaluation; study terminated due to slow accrual.|||||
105404|NCT00771537|Primary|Willingness to Participate in a HIV Vaccine Clinical Trial|Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).|Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.|Only participants who answered the Willingness to Participate questions on the survey were included in these analyses.||units on a scale||Standard Deviation|Mean
121176|NCT00633867|Secondary|Quality of View of the Vocal Cords||At analysis||||||
105406|NCT00771472|Secondary|Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||hours||Standard Deviation|Geometric Mean
105407|NCT00771472|Secondary|Part I: Time at Which Cmax Occurs (Tmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||hours||Full Range|Median
105408|NCT00771472|Secondary|Part I: Maximum Drug Concentration (Cmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||µM||Standard Deviation|Geometric Mean
105409|NCT00771472|Primary|Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)|"A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):~Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC~Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment~Grade 4 neutropenia lasting at least 5 days~Grade 4 thrombocytopenia~Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator~Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies"|Day 1 to Day 28|||participants|||Number
105410|NCT00771472|Secondary|Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point||µM*hr||Standard Deviation|Geometric Mean
105411|NCT00771472|Primary|Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)|A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.|Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)|||participants|||Number
105412|NCT00771407|Secondary|Stoma Quality of Life||Serially over 24 months||||||
105413|NCT00771407|Secondary|Stoma Complications||more than 1 month postoperatively||||||
105414|NCT00771407|Secondary|Stoma Complications||30 days||||||
105415|NCT00771407|Primary|Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.||24 months|Efficacy Evaluable Population (received assigned treatment, completed all protocol-required evaluations, no major protocol violations).||participants|||Number
105416|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.|||||
105417|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Clinical response at DCIV defined as: 1) Improved-All or most pretherapy signs and symptoms of infection have improved and no additional antibiotic is required, 2) Failure-No response to therapy, persistence or progression of pretherapy signs and symptoms, 3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.|||||
105418|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|5 to 9 days post therapy|This analysis was not completed due to early termination of the study.|||||
105419|NCT00771277|Secondary|Zarit Burden Inventory|Caregiver burden, as measured by the 12-item Zarit Burden Interview (Bédard et al., 2001; Zarit, Reever, & Bach-Peterson J, 1980). Burden includes concepts such as lack of time because of care, strain, restriction of life, etc. Items are scored from never (0) to nearly always (4), and higher total scores indicate greater burden. Total scores range from 0 to 88.|baseline|||units on a scale||Standard Deviation|Mean
105420|NCT00771277|Secondary|PHQ-9|The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) assesses caregiver depression and anxiety on a scale from not at all (0) to nearly every day (3), with higher total scores indicating greater symptoms. Scores range from 0-27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively.|baseline|||units on a scale||Standard Deviation|Mean
105421|NCT00771277|Primary|Number of Participants Who Reported 5 Themes|Six caregivers of TBI patients were interviewed; responses were transcribed and coded; inter-rater agreement was calculated. Themes were lack of understanding about TBI and its long-term effects and the differences between TBI and PTSD, privacy concerns, independence, fear of negative employment/financial repercussions, and difficulty in interactions with the Department of Defense (DoD) and the Department of Veterans Affairs (VA)|collected over 3 interviews of approximately 1 hour each|||participants|||Number
131668|NCT00538642|Secondary|Diastolic Blood Pressure||4-5 months|||mm Hg||Standard Deviation|Mean
105422|NCT00771264|Primary|"The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis."|A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.|13 weeks|Intent to treat||participants|||Number
105423|NCT00771238|Secondary|Cost of Rental Beds|Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only|End of study|Tertiary Care ICU patients||US Dollars|||Number
105424|NCT00771238|Primary|Indicence of Pressure Ulcers|New pressure ulcers were assessed|at the end of study period (21 days)|Tertiary Care ICU patients||participants|||Number
105425|NCT00771173|Primary|Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments|The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.|24 hours|Per Protocol||centimeters||Standard Deviation|Mean
105426|NCT00771056|Secondary|Time to Next Treatment|number of months to time from last HCQ dose to next CLL treatment|1 yr|only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose||months||Full Range|Mean
105427|NCT00771056|Primary|Percentage of Participants With Response|Percentage of participants with a reduction of the absolute lymphocytic count- ALC|1 yr|||percentage of participants|||Number
105428|NCT00770991|Primary|Change in Burden of Rectal Polyps|The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.|Baseline and 36 weeks|||polyp number x mm||Standard Deviation|Mean
105429|NCT00770991|Secondary|Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.|A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis.|baseline and 36 weeks|||percentage of brown staining of cells||Standard Deviation|Mean
105430|NCT00770991|Primary|Change From Baseline to End of Study in Number of Rectal Polyps||Baseline and 36 weeks|||polyps||Standard Deviation|Mean
105431|NCT00770965|Secondary|Investigator Global Assessment (IGA) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32||||||
105432|NCT00770965|Secondary|Change From Baseline in PASI|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, weeks 12, 14, 16, 20, 24, 28 and 32||||||
105433|NCT00770965|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, week 4||||||
105434|NCT00770913|Primary|Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)|Grade N indicates a normal appearance of lower esophageal mucosa|8 weeks|The primary analysis was on the full analysis set (FAS) population.||Percentage of Participants|||Number
105435|NCT00770861|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).|The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)|||mm Hg||Standard Deviation|Mean
105436|NCT00770861|Primary|Change From Baseline in Trough Seated DBP at Week 8(LOCF).|The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)|||mm Hg||Standard Deviation|Mean
105437|NCT00770809|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3|The type and grade of treatment-related toxicity will be tabulated by treatment arm.|Up to 30 days post-treatment||||||
105438|NCT00770809|Secondary|Time to First Failure|Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.|Time from study entry to any recurrence ( up to 10 years)||||||
105439|NCT00770809|Secondary|Relapse-free Survival (RFS)|Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.|Time from surgery to any recurrence (up to 10 years)||||||
105440|NCT00770809|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method|Time from randomization to death or last follow-up (up to 10 years)||||||
105441|NCT00770809|Secondary|Radiographic Response Rate (at Completion of Neoadjuvant Therapy)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).|Week 16||||||
105442|NCT00770809|Secondary|Pathologic Stage in the Breast and Axilla|Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.|At time of surgery||||||
105443|NCT00770809|Primary|pCR Rate|Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.|At time of surgery|Participants who did not start protocol therapy or withdrew prior to surgery are excluded. Participants who did not undergo surgery are considered no having a pCR.||percentage of participants||95% Confidence Interval|Number
105444|NCT00770770|Primary|Visual Acuity|To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.|3 months|||Letters||Standard Error|Mean
105445|NCT00770757|Post-Hoc|Survival Rate of CC-4047 Responders||Median follow-up 5.6 years (4.2-5.6 years)|Five participants have died and these were the participants who did not respond or were removed from study prior to cycle 3 due to adverse events.||percentage of participants|||Number
105446|NCT00770757|Post-Hoc|Chronic Graft-versus-host Disease Global Score at the Start/End of the Study|"Global scoring of chronic GvHD consists of questions about various organs including skin, genital tract, lungs, liver, and multiple others. The physician scores each organ from 0 to 3. Score 0 means the patient has no symptoms. Score 1 means the patient has mild symptoms. Score 2 means the patient has moderate symptoms. Score 3 means the patient has severe syptoms.~Mild scoring of chronic GvHD is only 1 or 2 organs or site (except the lung). No clinically significant functional impairment (maximum of score 1 in all affected organs or sites)~Moderate scoring of chronic GvHD is at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) or 3 or more organs or sites with no clinically significant functional impairment (maximum of 1 in all affected orgnas or sites)~Severe scoring of chronic GvHD is a major disability caused by chronic GvHD (score of 3 in any organ or site) and lung function score >=2."|1 year after last dose of CC-4047|||participants|||Number
105447|NCT00770757|Post-Hoc|Organ System Response||1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable||participants|||Number
105448|NCT00770757|Secondary|Safety as Measured by the Most Common Adverse Effects and Reasons for Dose Reductions or Study-discontinuation|-Toxicities will be graded according to the NCI CTCAE v3.0.|30 days after last dose of CC-4047 or until resolution of event|||participants|||Number
105449|NCT00770757|Primary|Overall Response (Complete Response + Partial Response + Other)|"CR is defined as complete resolution in all of signs and symptoms at all affected organs and tissues~PR is defined as improvement in greater than or equal to 1 organ/tissue with no progression in any other affected organ/tissue~Improvement in chronic GvHD symptoms less than what meets the definition of a PR is defined as other~Progressive disease is defined as failure of therapy to control chronic GvHD despite increasing the dose of primary therapy or adding second line treatments~No response is defined as no change in disease."|1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable||participants|||Number
105450|NCT00770692|Secondary|Mean Change From Baseline in Total Number of Awakenings|Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||Number of Awakenings||Standard Deviation|Mean
105451|NCT00770692|Secondary|Mean Change From Baseline in Total Sleep Time|Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||minutes||Standard Deviation|Mean
105461|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.60%)|The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
105530|NCT00770146|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||ratio||Standard Deviation|Mean
105452|NCT00770692|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO)|Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||minutes||Standard Deviation|Mean
105453|NCT00770692|Primary|Incidence of Adverse Events|"Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)*100.~An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF."|Up to 25 weeks (24 weeks treatment period & 1 week follow-up)|Safety analysis set: All 161 non-elderly participants who were enrolled in the treatment period were included. All 164 elderly patients who were enrolled in the treatment period were included. The participant who was excluded from the efficacy analysis set was included in the safety analysis set because the participant had evaluable safety data.||Percentage of Participants|||Number
105454|NCT00770692|Secondary|Mean Change From Baseline In Sleep Latency|Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.||minutes||Standard Deviation|Mean
105455|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (60.00).|The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
105456|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (30.00).|The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
105457|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (12.00).|The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
105458|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (6.00).|The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
105459|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (3.00).|The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
105460|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (1.20).|The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
107168|NCT00758459|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
105462|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.30%).|The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Deviation|Mean
105463|NCT00770653|Secondary|Change From Baseline in Von-Willebrand Factor.|The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||percent||Standard Error|Least Squares Mean
105464|NCT00770653|Secondary|Change From Baseline in E-Selectin.|The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
105465|NCT00770653|Secondary|Change From Baseline in Platelet Function.|The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||sec||Standard Error|Least Squares Mean
105466|NCT00770653|Secondary|Change From Baseline in Thromboxane B2.|The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||pg/mL||Standard Error|Least Squares Mean
105467|NCT00770653|Secondary|Change From Baseline in Soluble Vascular Cell Adhesion Molecule.|The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
105468|NCT00770653|Secondary|Change From Baseline in Soluble Intracellular Adhesion Molecule.|The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
105469|NCT00770653|Secondary|Change From Baseline in Matrix Metallo Proteinase-9.|The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||ng/mL||Standard Error|Least Squares Mean
105470|NCT00770653|Secondary|Change From Baseline in Soluble CD40 Ligand.|The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||pg/mL||Standard Error|Least Squares Mean
105471|NCT00770653|Secondary|Change From Baseline in Nitrotyrosine.|The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.||nmol/L||Standard Error|Least Squares Mean
105472|NCT00770653|Secondary|Intake of Study Medication Greater Than 80% and Less Than 120%.|The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||participants|||Number
105473|NCT00770653|Secondary|Change From Baseline in Diastolic Blood Pressure.|The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mmHg||Standard Deviation|Least Squares Mean
105474|NCT00770653|Secondary|Change From Baseline in Systolic Blood Pressure.|The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mmHg||Standard Error|Least Squares Mean
105557|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 8|||units on a scale||Standard Deviation|Mean
105475|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).|The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/L||Standard Deviation|Mean
105476|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Original).|The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/L||Standard Error|Least Squares Mean
105477|NCT00770653|Secondary|Change From Baseline in Adiponectin.|The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||μg/mL||Standard Error|Least Squares Mean
105478|NCT00770653|Secondary|Change From Baseline in Fasting Glucose.|The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105479|NCT00770653|Secondary|Change From Baseline in Fasting Intact Proinsulin.|The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||pmol/L||Standard Error|Least Squares Mean
105480|NCT00770653|Secondary|Change From Baseline in Glycosylated Hemoglobin.|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105481|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol.|The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105482|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Subfractions.|The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105483|NCT00770653|Secondary|Change From Baseline in Triglycerides.|The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105484|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.|The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105485|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol.|The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105486|NCT00770653|Primary|The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.|The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination.||mg/dL||Standard Error|Least Squares Mean
105487|NCT00770588|Secondary|Adverse Event|Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated.|AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored|||Participants|||Number
105488|NCT00770588|Secondary|Symptom Improvement|Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement.|at randomization, every 6 weeks until disease progression, and at discontinuation.|||Participants|||Number
131669|NCT00538642|Secondary|Diastolic Blood Pressure||Baseline|||mm Hg||Standard Deviation|Mean
105489|NCT00770588|Secondary|Disease Control Rate (DCR)|DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase|Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.||||||
105490|NCT00770588|Secondary|Objective Tumour Response (ORR)|The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.|||Participants|||Number
105491|NCT00770588|Secondary|Overall Survival (OS)|The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive.|The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive.|||month||95% Confidence Interval|Median
105492|NCT00770588|Primary|Progression Free Survival (PFS)|PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.|||month||95% Confidence Interval|Median
105493|NCT00770562|Secondary|Percentage of Participants With an Initial Complete Response|Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.||percentage of participants|||Number
105494|NCT00770562|Secondary|Percentage of Participants With an Initial Response|Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.||percentage of participants|||Number
105495|NCT00770562|Primary|Percentage of Participants With a Sustained Response|Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.|Week 24|The Intent-to-Treat (ITT) population includes all participants who were randomized, who received at least (<) 1 dose of study medication, and who had at least 1 follow-up contact.||percentage of participants|||Number
105496|NCT00770510|Primary|Sleep Latency (SL)|The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Standard Deviation|Mean
105497|NCT00770510|Secondary|Number of Awakenings (Objective & Subjective)|"Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Number of awakenings||Full Range|Median
105498|NCT00770510|Secondary|Wake Time After Sleep Onset (WASO)- Objective & Subjective|"Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Full Range|Median
105528|NCT00770146|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
110826|NCT00726830|Secondary|Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items||28 days||||||
105499|NCT00770510|Secondary|Sleep Efficiency|"Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent.~PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Percentage of time asleep of 8 hours||Full Range|Median
105500|NCT00770510|Secondary|Total Sleep Time (Objective & Subjective)|"Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Full Range|Median
105501|NCT00770510|Primary|Latency To Persistent Sleep (LPS)|The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.||Minutes||Standard Deviation|Mean
105502|NCT00770484|Primary|Maximal Oxygen Consumption Capacity (VO2 Max)||Over approximately 30 minutes, within 2 hours of receiving each intervention.|||mL/kg/min||Standard Error|Mean
105503|NCT00770432|Secondary|Binary Outcomes (Bowel Movement Satisfaction, Bowel Moevement Sense of Completion).|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|24 hours to 3 days after last dose of seven day treatment period.||||||
105504|NCT00770432|Secondary|Diary Ratings in Visual Analog Scale Format (Bowel Movement Control, Gas, Bloating, Abdominal Discomfort/Cramping, Well-being)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|24 hours to 3 days after last dose of seven day treatment period.||||||
105505|NCT00770432|Primary|Number of Participants With a Complete Resolution at the Final Visit|A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.|24 hours to 3 days after last dose of seven day treatment period.|Per-Protocol Population||Participants|||Number
105506|NCT00770367|Primary|Asymmetric Dimethylarginine (ADMA) Level|Labs measured micro moles per liter of ADMA levels in participants.|3 months|Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups.||umol/L||95% Confidence Interval|Mean
105507|NCT00770367|Secondary|NOx f2-isoprostanes|Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress|3 months||12/2010||||
105508|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at TOC|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
105509|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at EOT|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
105510|NCT00770341|Secondary|EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
105529|NCT00770146|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
107169|NCT00758459|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
105511|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
105512|NCT00770341|Secondary|EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.||Participants|||Number
105513|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)|"Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT).~MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline."|7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)|MITT-MRSA; One participant with possible MRSA RIE was enrolled. This participant was excluded from the efficacy population.||Participants|||Number
105514|NCT00770315|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
105515|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
105516|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
105517|NCT00770315|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
105518|NCT00770315|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.||score on a scale||Standard Error|Mean
105558|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 4|||units on a scale||Standard Deviation|Mean
105519|NCT00770289|Secondary|Number of Participants With Residual Symptoms in Case of Non Remission|Number of participants with residual symptoms who did not achieve remission was assessed. Remission according to HAM-D: HAM-D17 score =< 7 or HAM-D7 score =<3. Remission according to BDI: BDI score <10. HAM-D17: assessed 17 items associated with MD. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: assessed 7 items associated with MD. Total score: 0 to 26. BDI assessed severity of depressive symptoms. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. The total score: 0 to 63. For all the 3 scales, higher score indicated more severe depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.||participants|||Number
105520|NCT00770289|Secondary|Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)|HAM-D17: clinician-administered scale; assesses 17 items related to major depression (MD). Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: subset of HAM-D17; assesses 7 items related to MD. Total score: 0 to 26. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, physical symptoms of fatigue, weight loss, lack of interest in sex. Individual item scored on 4 point scale (0 to 3); 0=absent, 3=most severe. Total score: 0 to 63. For all the 3 scales, higher score represented more depression.|Baseline, Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available at baseline and were evaluable for this measure.||units on a scale||Standard Deviation|Mean
105521|NCT00770289|Secondary|Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)|Remission according to BDI: BDI score less than (<) 10. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
105522|NCT00770289|Primary|Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)|Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.|Week 12|Intent-to-treat (ITT) population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
105523|NCT00770211|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
105524|NCT00770211|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder as having a rating of none or mild||Participants|||Number
105525|NCT00770211|Secondary|1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
105526|NCT00770211|Secondary|Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder defined as having a rating of none or mild||Participants|||Number
105527|NCT00770211|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.||Particpants|||Number
105573|NCT00769652|Primary|Change in Fat Free Mass (FFM)||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.|||||
105531|NCT00770146|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
105532|NCT00770146|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
105533|NCT00770146|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
105534|NCT00770146|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
105535|NCT00770146|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
105536|NCT00770146|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
105537|NCT00770146|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
105538|NCT00770146|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
105539|NCT00770146|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
105540|NCT00770146|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
105541|NCT00770146|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
105542|NCT00770146|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
105543|NCT00770146|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Standard Deviation|Mean
105556|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 12|One of the subjects that dropped from the study in the Arimoclomol arm, returned for the 12 month visit.||units on a scale||Standard Deviation|Mean
105544|NCT00770146|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
105545|NCT00770146|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
105546|NCT00770146|Primary|Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
105547|NCT00770146|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald’s calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides >400 mg/dL. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Inter-Quartile Range|Median
105548|NCT00770029|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
105549|NCT00770029|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
105550|NCT00770029|Secondary|1-point Responders at Rest at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
105551|NCT00770029|Secondary|Responders at Rest at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.||Participants|||Number
105552|NCT00770029|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on Facial Wrinkle Scale (FWS) and by Patient’s Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.||Participants|||Number
105553|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 12|||newtons||Standard Deviation|Mean
105554|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 8|||newtons||Standard Deviation|Mean
105555|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 4|||newtons||Standard Deviation|Mean
105559|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 12|||units on a scale||Standard Deviation|Mean
105560|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 8|||units on a scale||Standard Deviation|Mean
105561|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 4|||units on a scale||Standard Deviation|Mean
105562|NCT00769860|Secondary|Heat Shock Protein 70 (HSP70) Levels in the Tissue|Biopsy taken from participants at baseline and month 4 visits. Measured change in HSP70 levels in the tissue.|Change from Baseline to Month 4|||ng/100ng myosin||Standard Deviation|Mean
105563|NCT00769860|Primary|Count of Adverse Events Reported|Measure reflects the total number of adverse events reported during course of the study.|Month 12|||adverse events reported|||Number
105564|NCT00769704|Secondary|Response Interval|Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per Investigator assessment.||months||95% Confidence Interval|Median
105565|NCT00769704|Secondary|Time to Treatment Failure|"Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis.~Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point.~Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent to treat population||months||95% Confidence Interval|Median
105566|NCT00769704|Secondary|Response Onset|Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.||months||95% Confidence Interval|Median
105567|NCT00769704|Secondary|Duration of Response|The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.||months||95% Confidence Interval|Median
105568|NCT00769704|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points.~Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population||percentage of participants||95% Confidence Interval|Number
105569|NCT00769704|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.|From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months.|Intent-to-treat population||months||95% Confidence Interval|Median
105570|NCT00769704|Primary|Durable Response Rate|"Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline.~Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times.||percentage of participants||95% Confidence Interval|Number
105571|NCT00769652|Primary|Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.|||||
105572|NCT00769652|Primary|Change in Weight||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.|||||
131670|NCT00538642|Secondary|Systolic Blood Pressure||4-5 months|||mm Hg||Standard Deviation|Mean
105574|NCT00769561|Secondary|TMD Related Symptoms|TMD related symptoms, such as jaw pain, toothache or dizziness, were measured using a 41-item TMD symptom list. Following the SOMS-7 scale, intensity of symptoms experienced during the past week was rated from 0 (‘not at all’) to 4 (‘very high intensity’) (range 0 - 164). A sum score was built with higher scores indicating higher intensity of TMD related symptoms. The TMD symptom list has not been evaluated previously; however, large bivariate correlations with somatization (Pearson’s r = .79), medium to large correlations with pain intensity (r = .48), and medium correlations with depression (r = .37) and anxiety (r = .27) provide evidence of good convergent and divergent validity. Cronbach’s alpha level in the current sample was excellent (α = .93).|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up|||units on a scale||Standard Deviation|Mean
105575|NCT00769561|Primary|Jaw Use Limitations (JDL)|Jaw use limitations were measured using the Jaw Disability List (JDL) from the RDC/TMD. The JDL asks the patient to rate interference with eleven oral activities, for example chewing or talking. We used an 11-point numeric rating scale (from 0 'no limitation' to 10 'maximum limitation') instead of ratings of ‘yes’ and ‘no’ (range 0 - 110). Higher values indicate higher levels of jaw use limitations. Cronbach's alpha was .86 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
105576|NCT00769561|Secondary|Pain Coping (FESV)|Cognitive and behavioral pain coping strategies were assessed with Coping Strategies Scale from the German Pain Coping Questionnaire (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV). The scale asks for the use of 24 cognitive (e.g. cognitive restructuring) and behavioral (e.g. use of relaxation techniques) strategies for coping with pain on a scale ranging from 1 ('fully disagree') to 6 ('fully agree') (range 24-144). A sum score was used with higher scores indicating more adaptive coping. Cronbach’s alpha level was α = .80.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
105577|NCT00769561|Secondary|General Anxiety Symptoms (GAD-7)|General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 (‘not at all’) to 3 (‘more than half of the days’) rating scale (range 7-21). Higher scores indicate higher levels of anxiety. Cronbach’s alpha level in the current sample was α = .64.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
105578|NCT00769561|Secondary|Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)|Depressive symptoms were measured using the Centre for Epidemiological Studies Depression scale (CES-D). The CES-D asks for the frequency of 20 symptoms of depression during the past week on a scale ranging from 0 (‘less than 1 day’) to 3 (‘5 to 7 days’) (range 0-60). Higher scores indicate more depressive symptoms. It is suitable for use in chronic pain patients as it relies less on physical symptoms of depression than do other measures. Cronbach’s alpha level in the current sample was α = .89.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
105579|NCT00769561|Secondary|Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)|Somatoform complaints during the past week were assessed using the Screening for Somatoform Symptoms (SOMS-7). 32 medically unexplained symptoms (29 for male subjects) representing DSM-IV criteria for somatization disorder were rated on a 0 ('not at all') to 4 ('very much') scale (range 0 - 128 for women and 0 - 116 for men). A sum score was calculated with higher scores indicating higher intensity and burden of somatoform complaints. In the current sample, Cronbach’s alpha level was α = .88.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|||units on a scale||Standard Deviation|Mean
105580|NCT00769561|Primary|Pain Disability (Pain Disability Index)|Pain related disability was assessed using the Pain Disability Index (PDI). The PDI is a brief self-rating scale which assesses the level of pain related disability in seven areas of daily life (e.g., social activity, self-care) on a 0 (no disability) -10 (maximum disability) numeric rating scale (range 0 - 70). Higher values indicate higher disability levels. Cronbach's alpha was .87 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
105581|NCT00769561|Primary|Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))|"Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)):~Characteristic pain intensity was calculated by averaging ratings of current pain, average pain, and worst pain in the past month on a numeric rating scale from 0 (no pain) to 10 (maximum pain), as recommended by RDC/TMD (range 0 - 10). Higher values indicate higher pain levels."|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
105582|NCT00769314|Secondary|Patient Assessment of Efficacy of the Treatment|At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.||participants|||Number
105583|NCT00769314|Secondary|Patient Satisfaction With Treatment|At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.||participants|||Number
105584|NCT00769314|Secondary|Symptom Intensity (Visual Analogue Scale [VAS])|"Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from 0 was measured in millimeters (0 - 100) and recorded."|Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)|This endpoint was analyzed using the safety population, which consisted of all randomized patients who took at least 1 dose of study medication.||units on a scale (0 - 100)||Standard Deviation|Mean
106101|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
105585|NCT00769314|Secondary|Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up|Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.||participants|||Number
105586|NCT00769314|Secondary|Time to Recurrence of Non-aborted Lesions During 9-month Follow-up|Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.||Days||95% Confidence Interval|Median
105587|NCT00769314|Primary|Time to Healing (TTH) of Vesicular Primary Lesion|Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.|Assessed from time of treatment initiation through Day 14|The modified Intent-to-Treat (mITT) population was the population used for analysis of this endpoint. The mITT population included all randomized patients who received at least one dose of study medication and who reached the vesicular stage (ie, episodes that progressed through macula, papule, vesicle, crust and healing).||Days||95% Confidence Interval|Median
105588|NCT00769314|Secondary|TTH of Aborted Primary Lesions|TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the subgroup of patients within the ITT population with aborted lesions.||Days||95% Confidence Interval|Median
105589|NCT00769314|Secondary|Time to Cessation of Symptoms|Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the ITT population.||Days||95% Confidence Interval|Median
105590|NCT00769314|Secondary|Duration of Episode (DOE)|For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last.|Assessed from initiation of treatment to Day 14|This endpoint was analyzed using the ITT population.||Days||95% Confidence Interval|Median
105591|NCT00769314|Secondary|TTH of Non-primary Lesions (Aborted Lesions Excluded)|TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using a subgroup of patients in the ITT population with non-primary lesions.||Days||95% Confidence Interval|Median
105592|NCT00769314|Secondary|Abortion of Primary Lesions|Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using the Intent-to-Treat (ITT) population, which consisted of all randomized patients who received at least one dose of study medication and who had complete information recorded for the application time.||participants|||Number
105593|NCT00769184|Secondary|Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions|Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval.|Weeks 2, 6, & 12|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.||Mean Percent Improvement||Full Range|Mean
105594|NCT00769184|Primary|Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.|Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.|Weeks 2, 6, & 12.|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.||percentage of participants|||Number
105595|NCT00769132|Secondary|Prostaglandin I Metabolite (PGI-M)|The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
105596|NCT00769132|Primary|Urinary 11-dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
106102|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
105597|NCT00769119|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105598|NCT00769119|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105599|NCT00769119|Secondary|Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105600|NCT00769119|Secondary|Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105601|NCT00769119|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105602|NCT00769119|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105603|NCT00769119|Secondary|Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105604|NCT00769119|Secondary|Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105605|NCT00769119|Secondary|Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105606|NCT00769119|Primary|St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Scores on a scale||Standard Error|Least Squares Mean
105636|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)|Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: <LLN-30; Gr 2: <30-20; Gr 3&4: <20.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
105607|NCT00769119|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||events|||Number
105608|NCT00769119|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
105609|NCT00769119|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
105610|NCT00769119|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/s||Standard Error|Least Squares Mean
105611|NCT00769119|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
105612|NCT00769119|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
105613|NCT00769119|Primary|Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
105614|NCT00769119|Primary|24-hour Sputum Weight(g)|Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||g||Standard Error|Least Squares Mean
105615|NCT00769119|Primary|Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105616|NCT00769119|Primary|Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
105617|NCT00769067|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.|Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||weeks||95% Confidence Interval|Median
105680|NCT00768651|Secondary|Acute Insulin Response to Arginine After the 3 Month Washout Period|An intravenous Arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.|3 months - washout period||||||
131671|NCT00538642|Secondary|Systolic Blood Pressure||Baseline|||mm Hg||Standard Deviation|Mean
105618|NCT00769067|Secondary|Duration of Response (DR)|Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Analysis population included sub-set of participants from ITT population who had a confirmed objective tumor response (CR or PR).||weeks||95% Confidence Interval|Median
105619|NCT00769067|Secondary|Best Overall Response (BOR)|Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||participants|||Number
105620|NCT00769067|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||percentage of participants||95% Confidence Interval|Number
105621|NCT00769067|Primary|Progression-Free Survival (PFS)|PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Intent-to-treat (ITT) population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.||weeks||95% Confidence Interval|Median
105622|NCT00769067|Other Pre-specified|Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)|Only participants from “Dacomitinib” treatment arm were planned to be analyzed for this outcome.|C1D10-14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis population: all participants who received >=1 dose of study medication, with treatment assignments designated according to actual study treatment received, and from whom at least 1 PK sample was obtained. Here “n” signifies participants who were evaluable at specified time-point.||ng/mL||Standard Deviation|Mean
105623|NCT00769067|Other Pre-specified|Soluble Protein Biomarkers Level|Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin [E-cadherin]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.|Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)|Biomarker analysis population: participants who received >=1 dose and had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. “N”(number of participants analyzed): participants evaluable for this measure; “n”: participants evaluable at each time-point for each arm respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
105624|NCT00769067|Other Pre-specified|Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation|Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as “unknown”. Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.|Baseline|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. The participants under the category EGFR T790M Mutation are already included in the EGFR Mutant category.||participants|||Number
105625|NCT00769067|Secondary|Dermatology Life Quality Index (DLQI)|DLQI: 10-item questionnaire to measure how much the participant’s skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.|Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. Here “N” (number of participants analyzed) signifies participants evaluable for this measure; “n” signifies participants evaluable for specified category for each arm, respectively.||units on a scale||Standard Deviation|Mean
131672|NCT00538642|Secondary|Abdominal Circumference||4-5 months|||cm||Standard Deviation|Mean
105626|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.||participants|||Number
105627|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.||participants|||Number
105628|NCT00769015|Secondary|Quality of Life: Social Function|Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
105629|NCT00769015|Secondary|Quality of Life: Role Functioning|Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
105630|NCT00769015|Secondary|Quality of Life: Mental Health|Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
105631|NCT00769015|Secondary|Vision Function: Near Activities|Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
105632|NCT00769015|Secondary|Quality of Life: Dependency|Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
105633|NCT00769015|Secondary|Vision Function: Distance Activities|Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months|||units on a scale||95% Confidence Interval|Least Squares Mean
105634|NCT00769015|Primary|Depression|The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.|4 months|||participants|||Number
105635|NCT00768989|Secondary|Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4|AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
105681|NCT00768651|Primary|Weight Change From Baseline After 6 Months of Therapy|Measuring the weight change from baseline at months: 1, 3, 6 and 9.|6 months||||||
105682|NCT00768651|Primary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy||6 months||||||
131673|NCT00538642|Secondary|Abdominal Circumference||Baseline|||cm||Standard Deviation|Mean
105637|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4|Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1–10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
105638|NCT00768989|Secondary|Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants|ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
105639|NCT00768989|Secondary|Raltegravir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Standard Deviation|Mean
105640|NCT00768989|Secondary|Atazanavir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Standard Deviation|Mean
105641|NCT00768989|Secondary|Atazanavir Individual Inhibitory Quotient (IQ)|Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Units on a Scale||Full Range|Geometric Mean
105642|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval|AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
105643|NCT00768989|Secondary|Raltegravir AUC (0-12h) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
105644|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
105645|NCT00768989|Secondary|Raltegravir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
105646|NCT00768989|Secondary|Atazanavir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng*h / mL||Standard Deviation|Geometric Mean
105647|NCT00768989|Secondary|Raltegravir Cmin 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
105648|NCT00768989|Secondary|Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||ng•h/mL||Standard Deviation|Geometric Mean
105649|NCT00768989|Secondary|Raltegravir Tmax|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Full Range|Geometric Mean
105650|NCT00768989|Secondary|Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.||Hours||Full Range|Geometric Mean
105651|NCT00768989|Secondary|Raltegravir Cmax in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.||ng/mL||Standard Deviation|Geometric Mean
105652|NCT00768989|Secondary|Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.||ng/mL||Standard Deviation|Geometric Mean
105653|NCT00768989|Secondary|Mean Change From Baseline in Electrocardiogram Findings|The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.|From Baseline to Week 24|All randomized participants who received at least 1 dose of study medication.||msec||Standard Error|Mean
105654|NCT00768989|Secondary|Mean Change From Baseline in Total Bilirubin Level||From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication.||mg/dL||Standard Error|Mean
105655|NCT00768989|Secondary|Baseline and Mean Change From Baseline in Total Cholesterol Levels|The mean change from baseline in participant fasting lipids was determined using fasting serum samples.|From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication. N=number of participants analyzed; n=number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
105683|NCT00768651|Primary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.|Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months||||||
105684|NCT00768651|Primary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months||||||
105656|NCT00768989|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.|Week 1 to Week 96, continuously|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
105657|NCT00768989|Secondary|Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count||From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results.||cells/mm^3||Standard Error|Mean
105658|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96||At Week 96 from Baseline|This analysis was not preformed due to early termination of the study.||Participants|||Number
105659|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48||At Week 48 from Baseline|The study terminated early, and this analysis was only done at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.||Participants|||Number
105660|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24|NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
105661|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96|Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases.|At Weeks 48 and 96 from Baseline|The study terminated early, and this analysis was done only at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.||Participants|||Number
105662|NCT00768989|Secondary|Number of Nonresponders at Week 8|Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.|At Week 8 from Baseline|The first 60 participants randomized, who received at least 1 dose of study medication.||Participants|||Number
105663|NCT00768989|Primary|Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24|The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC).|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.||Participants|||Number
105664|NCT00768898|Primary|Conjunctival Staining at 5 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|5 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
105665|NCT00768898|Primary|Conjunctival Staining at 4 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|4 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
105666|NCT00768898|Primary|Conjunctival Staining at 3 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|3 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
105667|NCT00768898|Primary|Conjunctival Staining at 2 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|2 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
105668|NCT00768898|Primary|Conjunctival Staining at 1 Minute|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|1 minute after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.||Units on a scale||Standard Deviation|Mean
105685|NCT00768651|Primary|C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months||||||
105686|NCT00768651|Primary|Acute Insulin Responses to Arginine After 6 Months of Therapy|An intravenous arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function.|6 months||||||
105669|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||units on a scale||95% Confidence Interval|Mean
105670|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||units on a scale||95% Confidence Interval|Mean
105671|NCT00768755|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Subgroup of participants from the FA population with a confirmed objective tumor response (CR or PR).||months||95% Confidence Interval|Median
105672|NCT00768755|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||percentage of participants||95% Confidence Interval|Number
105673|NCT00768755|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
105674|NCT00768755|Primary|Progression-Free Survival (PFS)|"Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was Death) or from the end of study data."|Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Full analysis (FA) population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
105675|NCT00768651|Secondary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|After the 3 month washout period||||||
105676|NCT00768651|Secondary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period||||||
105677|NCT00768651|Secondary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period||||||
105678|NCT00768651|Secondary|C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function. Ther|After the 3 month washout period||||||
105679|NCT00768651|Secondary|HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period|Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.|After the 3 month washout period||||||
117308|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 18 months|18 months|||kcal/wk||Standard Error|Mean
105689|NCT00768651|Primary|Change From Baseline of GLP-1 Level After One Month of Therapy|Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.|Baseline and One month||||||
105690|NCT00768651|Primary|Mean Daily Insulin Use (U/Day) After 6 Months of Therapy|Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.|6 months||||||
105691|NCT00768651|Primary|Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy||6 months||||||
105692|NCT00768651|Primary|Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy|HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.|6 months||||||
105693|NCT00768651|Primary|Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy||6 months||||||
105694|NCT00768651|Secondary|Insulin Dose (U/Day)||After the 3 month washout period||||||
105695|NCT00768651|Secondary|Insulin Independence After the 3 Month Washout Period|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|After the 3 month washout period|Per Protocol Set of participants; The subset of participants in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary and secondary variables.||% of insulin indipendent participants|||Number
105696|NCT00768651|Primary|The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|6 months|Per Protocol Set of participants: The participants of subjects in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary variables.||proportion of participants||95% Confidence Interval|Number
105697|NCT00768599|Secondary|Mycological Cure: Mocassin Disease|Negative KOH and negative fungal culture at Day 43|43|MITT||Participants|||Number
105698|NCT00768599|Secondary|Mycological Cure: Interdigital Disease|Negative KOH and negative fungal culture at Day 43|43|MITT||Participants|||Number
105699|NCT00768599|Secondary|Effective Treatment: Mocassin Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT||Participants|||Number
105700|NCT00768599|Primary|Complete Cure Rate: Moccasin Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|43 Days|MITT||Participants|||Number
105701|NCT00768599|Secondary|Effective Treatment: Interdigital Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT||Participants|||Number
105702|NCT00768599|Primary|Complete Cure Rate: Interdigital Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|Day 43|MITT||Participants|||Number
105703|NCT00768560|Secondary|Target Blood Pressure Achievement in All Subjects|Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
105704|NCT00768560|Secondary|Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder|Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
105705|NCT00768560|Secondary|Target Blood Pressure Achievement in Non-elderly (<65)|Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
105706|NCT00768560|Secondary|Target Blood Pressure Achievement in Elderly (≥65)|Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis||participants|||Number
105707|NCT00768560|Secondary|Differences of Diastolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis||mm Hg||Standard Deviation|Mean
105708|NCT00768560|Secondary|Differences of Systolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis||mm Hg||Standard Deviation|Mean
105709|NCT00768560|Primary|Change of Sitting Blood Pressure|Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])|Baseline and after 2 weeks treatment|Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.||mm Hg||Standard Error|Least Squares Mean
131674|NCT00538642|Secondary|Body Mass Index||4-5 months|||Kg/m2||Standard Deviation|Mean
105710|NCT00768521|Secondary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 1|All patients||Percentage change||90% Confidence Interval|Least Squares Mean
105711|NCT00768521|Primary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 7|All patients||Percentage change||90% Confidence Interval|Least Squares Mean
105712|NCT00768430|Primary|MADRS|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.|24 hours post-infusion|||units on a scale||95% Confidence Interval|Mean
105713|NCT00768300|Secondary|Percentage of Participants Who Developed PH on Study|The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.|Up to 48 weeks|Participants in the Full Analysis Set without PH at baseline were analyzed.||percentage of participants|||Number
105714|NCT00768300|Secondary|Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||units on a scale||Standard Deviation|Mean
105715|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George’s Respiratory Questionnaire (SGRQ)|The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||units on a scale||Standard Deviation|Mean
105716|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||units on a scale||Standard Deviation|Mean
105717|NCT00768300|Secondary|Change in 6MWT at Week 48|The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||meters||Standard Deviation|Mean
105718|NCT00768300|Secondary|Change in DLCO % Predicted at Week 48|DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||percent change in DLCO % predicted||Standard Deviation|Mean
105719|NCT00768300|Secondary|Change in FVC % Predicted at Week 48|FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.||percent change in FVC % predicted||Standard Deviation|Mean
105720|NCT00768300|Secondary|Proportion of Participants With No Disease Progression or Death at 48 Weeks|The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.|Baseline and Week 48|Full Analysis Set||percentage of participants|||Number
105721|NCT00768300|Primary|Time to Death or Disease (IPF) Progression.|"The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:~Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days~Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan~All-cause mortality"|Up to 48 months|Full Analysis Set: participants who were randomized and treated||weeks||Inter-Quartile Range|Median
105722|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 90|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105723|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 30|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105724|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 12|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
117309|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 12 months|12 months|||kcal/wk||Standard Error|Mean
105725|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 7|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105726|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 5|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105727|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 3|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105728|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|30 days|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105729|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|12 days|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105730|NCT00768222|Primary|Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)|Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar|30 days (+/- 5) post-operative|Intention to treat (ITT)||score on scale||Standard Deviation|Mean
105731|NCT00768144|Secondary|Progression-Free Survival|Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.||weeks||95% Confidence Interval|Median
105732|NCT00768144|Secondary|16-Week Progression-Free Survival|16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.||probability||95% Confidence Interval|Number
105733|NCT00768144|Primary|Overall Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
105734|NCT00768118|Primary|The Magnitude of Change in Blood Lymphocyte NF-kB Level|The target accrual goal is 15 subjects. It is hoped that of those 15, at least 10 will be intervention compliant, and provide both planned blood samples. NF-kB levels will be measured using a supershift assay, which tests the specificity and level of NF-kB in the sample by measuring the optical density of a scan. With 10 patients, the mean difference in blood lymphocyte NF-kB level could be estimated to within 0.44 standard 7 deviations, with 80% confidence. That is reasonable precision and confidence level for a small pilot study, and should provide sufficiently precise estimates for use in planning a subsequent study.|15 days|||Optical Density unit||90% Confidence Interval|Mean
105735|NCT00768066|Secondary|Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 Months post-catheterization|||percent change||95% Confidence Interval|Mean
105934|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Eosinophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105736|NCT00768066|Secondary|Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.|Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months post-catheterization|||units on a scale||95% Confidence Interval|Mean
105737|NCT00768066|Secondary|Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 months post-catheterization|||meters||95% Confidence Interval|Mean
105738|NCT00768066|Secondary|Number of Deaths||12-months post-catheterization|||participants|||Number
105739|NCT00768066|Secondary|Ectopic Tissue Formation.||12 months post-catheterization|||participants|||Number
105740|NCT00768066|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.||12 months post-catheterization|||participants|||Number
105741|NCT00768066|Secondary|Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization|||ng/mL||95% Confidence Interval|Mean
105742|NCT00768066|Secondary|Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization|||ng/mL||95% Confidence Interval|Mean
105743|NCT00768066|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||one month post-catheterization|||participants|||Number
105744|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12|American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105745|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12|American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105746|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12|American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105747|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12|American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105748|NCT00768053|Secondary|Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2|Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Baseline up to Week 12|All injected subjects population; DAS28 assessed at Week 4 and Week 12; sustained LDAS could only have been observed beyond Week 12. Time to event analysis not possible within study duration.||participants|||Number
105749|NCT00768053|Secondary|Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
106103|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
105750|NCT00768053|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105751|NCT00768053|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105752|NCT00768053|Secondary|Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105753|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).||percentage of participants|||Number
105754|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).||percentage of participants|||Number
105755|NCT00768053|Secondary|Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable.|Week 4, Week 12|All injected subjects population. Unacceptable value put to participants prematurely withdrawn or with missing data; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).||scores on a scale|||Number
105756|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).||percentage of participants|||Number
105757|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).||percentage of participants|||Number
105758|NCT00768053|Secondary|Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement.|Week 4, Week 12|All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).||scores on a scale|||Number
106104|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
105759|NCT00768053|Secondary|Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12|EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.||percentage of participants|||Number
105760|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 12|All injected subjects population||standardized response mean|||Number
105761|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 4|All injected subjects population||standardized response mean|||Number
105762|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.||correlation coefficient||95% Confidence Interval|Number
105763|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Week 12|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
105764|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Week 4|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
105765|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.||correlation coefficient||95% Confidence Interval|Number
105766|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Week 12|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
105767|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Week 4|All injected subjects population||correlation coefficient||95% Confidence Interval|Number
105804|NCT00767520|Primary|Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.||participants|||Number
105768|NCT00768053|Primary|Simplicity: Time for Completion of the EULAR-RAID Questionnaire|EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected).|Baseline up to Week 12|All injected subjects population. Data was not summarized; the time to complete the EULAR-RAID questionnaire was not analyzed separately from other components of the EULAR questionnaire (EULAR-RAID, questions on pain, Modified Health Assessment Questionnaire, sleep and coping)||minutes||Standard Deviation|Mean
105769|NCT00768053|Primary|Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score|EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial).|Screening, baseline|All injected subjects population: received at least 1 dose of study treatment (same as Safety population).||intraclass correlation coefficient||95% Confidence Interval|Number
105770|NCT00768040|Primary|Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment|The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor|Baseline to week 12|This study was terminated early due to low recruitment of patients.||μm||Standard Error|Least Squares Mean
105771|NCT00767806|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale|The Columbia Suicide Severity Rating Scale (C–SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.|baseline through 12 weeks|All randomized participants.||participants|||Number
105772|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Pulse Rate|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||beats per minute||Standard Error|Least Squares Mean
105773|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||kilogram||Standard Error|Least Squares Mean
105774|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Blood Pressure|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||millimeter mercury||Standard Error|Least Squares Mean
105775|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Total Protein|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Gram/Liter||Standard Error|Least Squares Mean
105776|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Creatinine|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Micromole/Liter||Standard Error|Least Squares Mean
105777|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Units/Liter||Standard Error|Least Squares Mean
105778|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|"All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing.~endpoints."||Units/Liter||Standard Error|Least Squares Mean
105779|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Units/Liter||Standard Error|Least Squares Mean
105780|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Albumin|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Gram/Liter||Standard Deviation|Least Squares Mean
105781|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Uric Acid|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||Micromole/Liter||Standard Error|Least Squares Mean
105782|NCT00767806|Secondary|Participants Who Discontinued From Baseline to 12 Weeks|Reasons for discontinuation are listed in the participant flow.|baseline, 12 weeks|All randomized participants.||participants|||Number
105827|NCT00767325|Secondary|Number of Participants With Adverse Events (AEs) of Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Infusion reaction: acute=1 hour or less after start of dosing; periinfusional=24 hours or less after start of dosing.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.||Participants|||Number
107170|NCT00758459|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in FEV1 from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||L||Full Range|Mean
105783|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism~Presenteeism~Work productivity loss~Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment."|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints. Not for all participants were data for all WPAI items available.||units on a scale||Standard Deviation|Mean
105784|NCT00767806|Secondary|Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension|Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
105785|NCT00767806|Secondary|Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
105786|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
105787|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
105788|NCT00767806|Secondary|Patient's Global Impression of Improvement (PGI-I) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
105789|NCT00767806|Secondary|Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
105790|NCT00767806|Secondary|Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution|The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.|12 weeks|All randomized participants with non-missing baseline value; baseline observation carried forward method was used to impute missing endpoints.||participants|||Number
105791|NCT00767806|Secondary|Number of Sustained Responders at 12 Week Endpoint|Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||participants|||Number
105915|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
105792|NCT00767806|Secondary|Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||participants|||Number
105793|NCT00767806|Secondary|Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||participants|||Number
105794|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Error|Least Squares Mean
105795|NCT00767806|Secondary|Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.||units on a scale||Standard Deviation|Mean
105796|NCT00767806|Primary|Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
105797|NCT00767676|Primary|Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale|"To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)]~No statistical analyses were performed."|7 weeks|Per protocol||participants|||Number
105798|NCT00767624|Secondary|Percentage of Participants in Insomnia Remission|Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.|16 weeks|||percentage of particpants in arm|||Number
105799|NCT00767624|Primary|Percent of Participants With Depression Remission|"Depression remission was defined if both a and b below are satisfied~absence of both depressed mood and anhedonia for at least three consecutive weeks~no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks"|16 weeks|||percentage of participants in arm|||Number
105800|NCT00767572|Primary|Pre-post Change in Brachial Artery Reactivity|Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.|Baseline, 12 weeks|12 enrolled participants were randomly assigned to receive a 12-week course of either atorvastatin or placebo, followed by a 4-week washout, then 12 weeks on the alternate intervention.||mm||Standard Deviation|Mean
105801|NCT00767520|Secondary|Number of Participants With Abnormalities in Electrocardiograms||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||05/2013||||
105802|NCT00767520|Secondary|Number of Participants With Abnormalities in Vital Signs||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||05/2013||||
105803|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)|Grade (GR)1= mild, GR2= moderate, GR3= severe, GR4= life threatening. Ranges are provided by the local laboratory and may vary according to sex and age. Phosphorous, GR1:<LLN 2.5 mg/dL, GR2:<2.5–2.0 mg/dL, GR3: 1.0-<2.0 mg/dL; Low sodium,GR1:<LLN 130mmol/L, GR3:120-<130 mmol/L; High Magnesium, GR1 >ULN 3.0 mg/dL,GR 3:<0.3 0.8mg/dL; Uric acid, GR1:>ULN 10 mg/dL, GR4:>10 mg/dL; Low potassium, GR1:<LLN 3.0mmol/L,GR3:<3.0 2.5mmol/L; High potassium, GR1:>ULN–5.5 mmol/L, GR2:>5.5–6.0 mmol/L; Bicarbonate, GR1:<LLN–16 mmol/L; GR2:<16 – 11 mmol/L; Hig sodium, GR1:>ULN–150 mmol/L,GR2:>150–155 mmol/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
105949|NCT00766090|Secondary|Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period|Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||beats per minute||Standard Deviation|Mean
105805|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)|Grade (GR) 1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening). Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, GR 1: >ULN–2.5 x ULN (upper limit of normal), GR 2: >2.5–5.0 x ULN, GR 3: 5.0-20.0 x ULN; Low calcium, GR 1: <LLN – 8.0 mg/dL, GR 2: <8.0–7.0 mg/dL, GR 4:<6.0 mg/dL; High calcium, GR 1:>ULN – 11.5 mg/dL; bilirubin, GR 1: >ULN–1.5 x ULN,GR 3: >3-10 x ULN; Creatinine, GR1:>ULN–1.5 x ULN, GR2: >1.5–3.0 x ULN; Albumin, GR1:<LLN–3 g/dL,GR2:<3–2 g/dL.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
105806|NCT00767520|Secondary|Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)|Abnormalities were graded per NCI-CTC, Version 3.0 criteria. Grade (GR)1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening. Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Granulocytes, GR 1;<LLN–1.5x 10^9/L, GR 2:<1.5–1.0x10^9/L, GR 3: <1.0 – 0.5x10^9/L, GR, 4: <0.5x10^9 /L; Hemoglobin, GR 1: <LLN–10.0 g/dL, GR 2: <10.0–8.0 g/dL, GR 3: <8.0–6.5 g/dL, GR, 4: <6.5g/dL; Platelets, GR 1: <LLN–75.0x10^9/L, GR 2: <75.0–50.0x10^9/L, GR 3: <50.0-25.0x10^9/L; Leukocytes, GR 1: <LLN–3.0x10^9/L, GR 2: <3.0–2.0x10^9/L, GR 4: <1.0x10^9/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
105807|NCT00767520|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade (GR)1 = mild, GR 2 = moderate, GR 3=severe, GR 4=life threatening, GR 5=death.|From start of study drug therapy up to 30 days after the last dose. Median duration of therapy (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.||participants|||Number
105808|NCT00767520|Secondary|Changes in Markers of Bone Lysis in Participants With Bone Metastasis|Assay for urinary N-telopeptide was used to evaluate Osteolytic activity.|Screening, Day 1, after week 2, 4, and week 8 and subsequently every 8 weeks, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||05/2013||||
105809|NCT00767520|Secondary|Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis|Pain intensity evaluated by administration of the Brief Pain Inventory - Short Form (BPI-sf). The BPI-sf is a psychometrically-validated instrument which measures both pain severity and functional interference caused by pain using an 11-point numerical rating scale. Severity of pain at its “worst”, “least” and “on average” in the last 24 hours, and “right now” (ie, at the time the questionnaire is being filled out) is recorded using anchors of “no pain” = “0” and “pain as bad as you can imagine” = “10”.|Start of study, at treatment start, after 2, 4, and 8 weeks of therapy and every 8 weeks thereafter, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||05/2013||||
105810|NCT00767520|Secondary|Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Duration of response is defined as the time from date that measurement criteria are first met for PR or CR until first date of documented PD or death. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer.||05/2013||||
105811|NCT00767520|Secondary|Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Time to response is defined as time from first dose of study therapy until measurement criteria are first met for PR or CR (whichever is recorded first). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until CR or PR. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer||05/2013||||
105812|NCT00767520|Secondary|Participants With Freedom-From-Progression (FFP) at 6 Months|FFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months.|at 6 months||05/2013||||
105813|NCT00767520|Secondary|Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Response= Proportion of response-evaluable participants whose best response is CR or PR. Confidence intervals was computed using the Clopper-Pearson method. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks)|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.||percentage of participants||95% Confidence Interval|Number
106105|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
105814|NCT00767520|Secondary|Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months|CB = participants whose best response is CR, PR, or stable disease(SD). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value). Confidence interval computed by Clopper-Pearson method.|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.||percentage of participants||95% Confidence Interval|Number
105815|NCT00767520|Secondary|Number of Participants With Best Overall Response|Complete response (CR) = Disappearance of all measurable and non-measurable lesions, and no new lesions; Partial response (PR) = Decrease ≥30% from baseline in sum of longest diameters (LD) of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value).|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.||participants|||Number
105816|NCT00767520|Primary|Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.||weeks||95% Confidence Interval|Median
105817|NCT00767507|Secondary|Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner||Through 7 days or hospital discharge, whichever was sooner|||patients|||Number
105818|NCT00767507|Secondary|Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild||Randomization until start of CABG surgery|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.||participants|||Number
105819|NCT00767507|Secondary|Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding|Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of >1.5 liters (L), and/or packed red blood cell transfusions > 4 units|Randomization through Hospital discharge|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.||Patients|||Number
105820|NCT00767507|Secondary|Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU|"This endpoint analyzed the percent of patients with platelet reactivity < 240 PRU at the following timepoints:~Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition)~Last sample during infusion~Following discontinuation of study drug infusion"|baseline until just prior to surgery (post infusion)|||percent of patients|||Number
105821|NCT00767507|Primary|Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.|"This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events.~Patients had multiple samples and all on-infusion samples had to be <240 PRU to meet the endpoint."|During study drug infusion up to 1-6 hours prior to surgery|"Based on available data from ITT population; ITT population (Cangrelor N = 93) / (Placebo N = 90).~Valid PRU results were not available during the infusion period for 15 patients (9 cangrelor and 6 placebo)."||Percent of patients|||Number
105822|NCT00767507|Primary|Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.|Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).|During study drug infusion up to 1-6 hours prior to surgery|||percentage of samples|Participants||Number
105823|NCT00767455|Primary|Presence of Cumulative Irritation|Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).|22 days|Per protocol||units on a scale|||Number
105824|NCT00767364|Secondary|Serum Anti-rotavirus IgA Level Post-vaccination|Serum anti-rotavirus IgA level was measured post-vaccination in all subjects|6 months from the first vaccination date|||U/ml|||Number
105825|NCT00767364|Primary|Safety and Tolerability of the Oral RotaTeq® Vaccine|Adverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.|12 months from the first vaccination date|||Individual Adverse Events|||Number
105826|NCT00767338|Primary|Number of Live Births After Eight Cycles of Infertility Treatment.||January 2009 to January 2012|The participants analyzed correspond to the number of participants who completed the study. In two of the arms, the study was terminated before participants were randomized to those arms.||participants|||Number
107171|NCT00758459|Primary|Incidence of Adverse Events|Number of patients who had an Adverse Event|all study visits|||Participants|||Number
105828|NCT00767325|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events(SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.||Participants|||Number
105829|NCT00767325|Secondary|Number of Early (Days 7 to 113) Global PDUS MCP 2-5 Scores or Global PDUS Component MCP 2-5 Scores Associated With an Acceptable Predictability of Clinical Response at Day 169, As Assessed by DAS28-CRP|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography; DAS=Disease Activity Score;CRP=C-reactive protein. Receiver Operator Characteristics (ROC) analysis assessed predicatability. ROC curve analyses performed; area under the curve of ≥0.7 was considered acceptable for prediction. Clinical response defined as: Clinically Meaningful Improvement=drop from baseline of ≥1.2 in DAS28-CRP; Remission=DAS28-CRP score <2.6; Low Disease Activity=≤3.2. PDUS scores: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH with ≤Gr 2 Doppler signal or minimal SH and Gr 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint rated 1-3, for a total possible score ranging from 8-24 (8*1, 8*3)for the 2 hands. Higher gr/score=more severe disease.|Days 1 to 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Scores|||Number
105830|NCT00767325|Primary|Earliest Time Point at Which Improvement of Core Component of the Global PDUS in the MCP (2-5) Joints of Both Hands Was Assessed|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography. Time point at which early signs of Global PDUS improvement were observed=earliest time point for which 0 was not included in the 95% confidence interval for the mean changes from baseline in Global PDUS (MCP 2-5) score at that and all later time points. Total PDUS scores are independent of the presence and grade of joint effusion: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH, with ≤Gr 2 Doppler signal or minimal SH and grade 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher Gr/score=more severe disease.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Day|||Number
105831|NCT00767325|Secondary|Mean Change From Baseline in Global PDUS MCP 2-5 Component Scores Over Time (LOCF Analysis)|PDUS=power Doppler ultrasonography; MCP=metacarpophalangeal; LOCF=last observation carried forward. PDUS was used to assess the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and grade 2 Doppler signal); Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤ Grade 3 Doppler signal or minimal or 1-3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher grade/score=more severe disease. Change=score Day X-baseline score.|Days 7, 15, 29, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Units on a scale||Standard Error|Mean
105832|NCT00767325|Primary|Mean Change From Baseline in Global Power Doppler Ultrasonography (PDUS) Score Assessing the Metacarpophalangeal (MCP) 2-5 Joints of Both Hands (LOCF Analysis)|LOCF=last observation carried forward. PDUS assessed the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. Total PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and Grade 2 Doppler signal; Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤Grade 3 Doppler signal or minimal or moderate synovial hypertrophy and Grade 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for 2 hands. Higher grade/score=more severe disease. Change=score Day x - baseline score.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.||Units on a scale||95% Confidence Interval|Mean
105833|NCT00767039|Secondary|Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.|Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.|NICU hospitalization, up to 42 weeks post menstrual age|All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at > 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.||Subjects with BPD + Neonatal Deaths||90% Confidence Interval|Number
107312|NCT00756977|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||mg/dL||Standard Deviation|Mean
105834|NCT00767039|Secondary|Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)|Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.|36 weeks post menstrual age|Population analyzed was limited to those subjects who survived to >36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at >36 weeks post menstrual age) were tallied.||Surviving Subjects with BPD||90% Confidence Interval|Number
105835|NCT00767039|Secondary|Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant|Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.|One hour following second surfactant dose at 12-24 hours after initial dose|The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.||Percent change from baseline velocity||Standard Error|Mean
105836|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20-Percent of O2||Standard Error|Mean
105837|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20-Percent of O2||Standard Error|Mean
105838|NCT00767039|Secondary|Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)|Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.|First hour after 2nd surfactant dose|Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.||cc/min||Standard Error|Mean
105839|NCT00767039|Secondary|Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)|Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.|Hemodynamically significant PDA at > 2 days|Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at >3 days, were tallied||Subjects||90% Confidence Interval|Number
105840|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|72 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.||Participants successfully extubated||90% Confidence Interval|Number
105841|NCT00767039|Primary|Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20||Standard Error|Mean
105842|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|48 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.||Participants successfully extubated||90% Confidence Interval|Number
105971|NCT00765882|Secondary|12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||CSBM per week||Standard Error|Least Squares Mean
105843|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.||cm H20||Standard Error|Mean
105844|NCT00767000|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event||Entire study including 54-week study and 104-week extension|||percentage of participants|||Number
105845|NCT00767000|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Entire study including 54-week study and 104-week extension|Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.||percentage of participants|||Number
105846|NCT00767000|Secondary|Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%||Weeks 54, 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158|||||
105847|NCT00767000|Secondary|Percentage of Participants Who Achieve an HbA1c of <7.0%||Weeks 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158|||||
105848|NCT00767000|Secondary|Change in the Fasting Plasma Glucose Level|Least squares mean change from baseline in fasting plasma glucose.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
105849|NCT00767000|Secondary|Change in the Two-hour Post Meal Glucose Level|Least squares mean change from baseline in 2-hour post meal glucose level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.||mg/dL||95% Confidence Interval|Least Squares Mean
105850|NCT00767000|Primary|Change in Hemoglobin A1c (HbA1c) Level|Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.||Percent HbA1c||95% Confidence Interval|Least Squares Mean
105851|NCT00766831|Secondary|Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug|"Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were I experienced a certain pain relief effect during the administration of the drug, I didn’t wake up due to pain while sleeping, It was more convenient because the number of administrations was reduced, I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain and other."|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Percentage of participants|||Number
105852|NCT00766831|Secondary|Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug|Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.|Day 15|ITT population included all the participants who received at least one dose of study medicaation and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.||Percentage of participants|||Number
105853|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators|Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
105854|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants|Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least one dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
105855|NCT00766831|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score|The CGI-Improvement score evaluates how much the participant’s condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
105856|NCT00766831|Secondary|Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score|The ECOG performance status was used to evaluate participant’s disease progression and the effect of the disease on the participant’s activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
105916|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score|Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
105857|NCT00766831|Secondary|Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain|The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'N' signifies participants who were evaluated for this outcome measure.||Frequency of breakthrough pain drug||Standard Deviation|Mean
105858|NCT00766831|Secondary|Participant’s Pain Intensity|Participant’s pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Units on a scale||Standard Deviation|Mean
105859|NCT00766831|Secondary|Korean Brief Pain Inventory (K-BPI) Questionnaire Score|K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies the number of participant who were evaluated for particular category at particular time point.||Units on a scale||Standard Deviation|Mean
105860|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you wake up because of unbearable pain this morning?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
105861|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Frequency of Waking Up|The Investigator evaluated sleep disturbance through the participant’s answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn’t fall asleep at all] of waking up due to pain last night).|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies participants who were evaluated for this outcome measure at a particular time point.||Participants|||Number
105862|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Analgesic Administration|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you need to take an analgesic for pain relief in order to go to sleep last night?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.||Participants|||Number
105863|NCT00766831|Primary|Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain|Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.|Day 15 or Early withdrawal|Intent to treat (ITT) population included all the participants who received study medication at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.||Percentage of treatment response||95% Confidence Interval|Number
105864|NCT00766675|Secondary|Number of Participants With Subject's Global Assessment|Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.||Participants|||Number
105865|NCT00766675|Secondary|Number of Participants With Physician Global Assessment|The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.||Participants|||Number
105866|NCT00766675|Secondary|Total Fibromyalgia Impact Questionnaire (FIQ) Score|The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.|Baseline and Day 56|"The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."||Units on a scale||Standard Deviation|Mean
105917|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
117310|NCT00670462|Secondary|Mood State||baseline, 6, 12, 18, and 30 months||||||
105867|NCT00766675|Secondary|Participant Assessment Sleep Questionnaire Score|Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to “How often during past 4 weeks did participant felt” and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
105868|NCT00766675|Secondary|Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept|The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant’s sleep habits out of which Q1 was “How long did it usually take for participant to fall asleep during the past 4 weeks” and Q2 was “On the average, how many hours did participant sleep each night during the past 4 weeks”.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Hours||Standard Deviation|Mean
105869|NCT00766675|Secondary|Tender-Point Evaluation/ Myalgic Score|Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
105870|NCT00766675|Secondary|Number of Participants With Categorical Scores on Pain Relief Rating Scale|Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.|Day 14, 28 and 56|The ITT population included all enrolled participants.||Participants|||Number
105871|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 56|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Millimeter (mm)||Standard Deviation|Mean
105872|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 28|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 28|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Millimeter (mm)||Standard Deviation|Mean
105873|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 14|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 14|Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Millimeter (mm)||Standard Deviation|Mean
105874|NCT00766649|Secondary|Change in Photoreceptor Outer Segment (PROS) Thickness as Measured by Optical Coherence Tomography at 24 Months as Compared to Baseline||Baseline and Month 24||||||
105875|NCT00766649|Secondary|Change in Drusen Volume as Measured by Optical Coherence Tomography (OCT) at 24 Months as Compared to Baseline||Baseline and Month 24||||||
105876|NCT00766649|Secondary|Change in Total Area of Drusen in the Fellow Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
105877|NCT00766649|Secondary|Change in Total Area of Drusen in the Study Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
105878|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24|||MPS DA/month||Standard Deviation|Mean
105879|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24|||MPS DA/month||Standard Deviation|Mean
105880|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the fellow eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline and Month 24|||Ratio|Participants|Standard Deviation|Mean
106106|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
105881|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline to Month 24|||Ratio|Participants|Standard Deviation|Mean
105882|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the fellow eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
105883|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24|||MPS DA|Participants|Standard Deviation|Mean
105884|NCT00766649|Secondary|Number of Study Eyes With a 15 Letter Drop From Baseline at 24 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Month 24|||eyes|Participants||Number
105885|NCT00766636|Primary|Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.|Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report|Following resection performed at time of surgery, day 36 of treatment +/- 5 days|The study was terminated early without enough patients to perform any analysis between the groups. Of the five registered, one withdrew prior to any treatment and the others either had disease progression or left prior to surgery with incomplete preoperative regimen.|||||
105886|NCT00766597|Secondary|Change in Plasma HIV RNA PCR|Changes in HIV RNA (copies/mL) from baseline to Week 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
105887|NCT00766597|Secondary|Change in Polymerase Genome and Envelope Sequence|Number of subjects with changes in genotypic and phenotypic drug resistance to the OBT and to vicriviroc (envelope sequence) from baseline to Week 24 and/or virologic failure will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
105888|NCT00766597|Secondary|Change in CD4 Percent|Change in CD4 percent from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
105889|NCT00766597|Secondary|Change in CD4 Counts|Change in CD4 count from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
105890|NCT00766597|Secondary|Number of Participants With Changes in Co-receptor Tropism From Baseline|Among all patients enrolled in Step I, the prevalence of detectable coreceptor phenotype, R5 tropic, R5/X4 mixed and X4 tropic viruses will be evaluated. The extent to which coreceptor phenotype in Step I is associated with Step I CD4 cell count, HIV RNA, and age will be evaluated. The association of Step I coreceptor phenotype and nadir CD4, HIV subtype, number of ART regimens, and years of ART will be evaluated. At the time of virologic failure, the extent of change from Step I and/or baseline R5 tropic virus to R5/X4 mixed or to X4 tropic virus as detected by the TrofileTM assay will be evaluated.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
117311|NCT00670462|Secondary|Triglycerides||baseline, 6, 12, 18, and 30 months||||||
105891|NCT00766597|Secondary|Number of Participants Who Failed to Achieve =>1-log Drop From Baseline in HIV-1 Viral Load and HIV-1 Viral Load of =>400 Copies/mL (Virologic Failures)|Plasma HIV RNA (RNA) concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular). The primary definition of virologic success will require subjects to have achieved and maintained 1-log drops from baseline of HIV-1 RNA or HIV-1 RNA <400 copies/mL.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.|||||
105892|NCT00766597|Primary|Number of Participants Who Failed to Meet PK Targets|For Stage I subjects who are enrolled in Step II, the average of the pre-dose and 24 hour post dose sample from the intensive PK evaluations of said subjects will be used as the estimate of Cmin. The whole cohort will fail the PK targets if the population target (median vicriviroc Cmin should be =>200 ng/mL) is not met, and that nearly all of subjects’ Cmin failed to be > 100 ng/mL.|At Week 24|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II and who failed the PK targets. Outcome measure not analyzed since the PK targets were for the whole cohort, but the lone cohort opened was not fully enrolled due to early study termination.|||||
105893|NCT00766597|Primary|Number of Participants With Adverse Events of Grade 3 or Higher Severity|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II||participants|||Number
105894|NCT00766597|Primary|Number of Participants With Suspected Adverse Drug Reaction Leading to Treatment Termination|The protocol required reporting of signs and symptoms and laboratory abnormalities of >=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules is to be determined by the Study Team. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR5-tropic virus who started treatment in Step II.||participants|||Number
105895|NCT00766532|Primary|Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy|intestinal calcium absorption|baseline and 6 weeks later|12 subjects provided informed consent but two dropped and did not undergo calcium absorption study visits. 10 subjects completed all calcium absorption study visits.||percent calcium absorption||Standard Deviation|Mean
105896|NCT00766506|Other Pre-specified|Number of Participants Facing Technical Failure of the Device|Technical failure was defined as malfunctioning or failure of device to work appropriately.|Baseline up to end of study treatment (Hour 72)|Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once.||Participants|||Number
105897|NCT00766506|Secondary|Number of Participants Who Require Concomitant Non-opioid Analgesics|Non-opioid analgesics are non morphine like medications used to get relieve from pain.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Participants|||Number
105898|NCT00766506|Secondary|Number of Participants Who Require Concomitant Antiemetic Medication|Antiemetic medicines are the drugs which prevent vomiting.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Participants|||Number
105899|NCT00766506|Secondary|Number of Participants Who Require Rescue Medication|Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.|Baseline up to Hour 3|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Participants|||Number
105900|NCT00766506|Other Pre-specified|Time to Actual Discharge|The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.|When participant was actually discharged from ward care (assessed up to 258.5 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Hours||95% Confidence Interval|Median
105901|NCT00766506|Secondary|Time to Fit For Discharge (FFD)|Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a “Yes” or “No” basis. When all criteria were answered as Yes, participant was considered to be FFD.|When participant was FFD (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Hours||95% Confidence Interval|Median
106107|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
105902|NCT00766506|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: “Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early study withdrawal|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
105903|NCT00766506|Secondary|Nurse Ease of Care (EOC) Questionnaire Score|Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from ‘not at all’ (Score 0) to ‘a very great deal’ (score 5). The total score was calculated as the mean of the non-missing items for all the questions.|When participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Units on scale||95% Confidence Interval|Least Squares Mean
105904|NCT00766506|Secondary|Pain Intensity Numerical Rating Scale (NRS)|Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant’s pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.|Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Unit on Scale||Standard Deviation|Mean
105905|NCT00766506|Primary|Participant’s Evaluation of Mean Ability to Mobilize After Surgery|The ability to mobilize was assessed through a combined analysis of participant’s responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from “not at all” (score 0) to “a very great deal” (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).|Hour 72 or early study withdrawal|The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).||Units on scale||Standard Deviation|Mean
105906|NCT00766493|Secondary|Neurologic Events|Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).|30 days|||Participants|||Number
105907|NCT00766493|Secondary|Access Site Complications|Access Site Complications defined as the presence of a large hematoma (>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.|30 days|||Participants|||Number
105908|NCT00766493|Secondary|Clinical Success|Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.|30 days|||Participants|||Number
105909|NCT00766493|Secondary|Device Success|Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).|Post Procedure|||Participants|||Number
105910|NCT00766493|Primary|Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure||30 days|EMBOLDEN subjects evaluable for the primary endpoint||Participants|||Number
105911|NCT00766467|Secondary|Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment|To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.|56 days|Grade 3 - 4 events at least possibly related to study treatment.||number of incidents|||Number
105912|NCT00766467|Secondary|Change From Baseline in Quality of Life at Days 22, 43 and 56|The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.|baseline, day 22, day 43, and day 56|Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.||units on a scale||80% Confidence Interval|Median
105913|NCT00766467|Primary|Change From Baseline in Fatigue at Day 43|The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue.|43 days|Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.||units on a scale||80% Confidence Interval|Median
105914|NCT00766415|Secondary|Adverse Event (AE)|Number of participants with an Adverse Event|1 month|||Participants|||Number
105918|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score|Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
105919|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Evening|Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||95% Confidence Interval|Mean
105920|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Morning|Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||95% Confidence Interval|Mean
105921|NCT00766415|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)|Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||95% Confidence Interval|Mean
105922|NCT00766415|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage change||95% Confidence Interval|Mean
105923|NCT00766415|Primary|Induced Sputum: Total Cells Count|Change in Induced sputum Total cells count from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||10^6/g||95% Confidence Interval|Mean
105924|NCT00766415|Primary|Induced Sputum: Epithelial Cells Count (%)|Change in Induced sputum Epithelial cells count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105925|NCT00766415|Primary|Induced Sputum: Lymphocytes Count (%)|Change in Induced sputum Lymphocytes count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105926|NCT00766415|Primary|Induced Sputum: Macrophages Count (%)|Change in Induced sputum Macrophages count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105927|NCT00766415|Primary|Induced Sputum: Neutrophils Count (%)|Change in Induced sputum Neutrophils count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105928|NCT00766415|Primary|Induced Sputum: Eosinophil Count (%)|Change in Induced sputum Eosinophil count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105929|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Total Cells Count|Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||10^6/g||95% Confidence Interval|Mean
105930|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)|Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105931|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)|Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105932|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Macrophages Count (%)|Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
105933|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Neutrophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||percentage||95% Confidence Interval|Mean
117312|NCT00670462|Secondary|HDL||baseline, 6, 12, 18, and 30 months||||||
105935|NCT00766415|Primary|Aggregated Pathology Score|Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.||Score on a scale||95% Confidence Interval|Mean
105936|NCT00766376|Secondary|Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.|To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.|participants at three months|||Participants|||Number
105937|NCT00766376|Primary|Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.|To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.|participants at three months|||Participants|||Number
105938|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])|Rivastigmine PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for rivastigmine after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.||h*ng/mL||Standard Deviation|Mean
105939|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)|Rivastigmine PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.||hours||Standard Deviation|Mean
105940|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)|Rivastigmine PK data; Maximum Concentration (Cmax); i.e, highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.||ng/mL||Standard Deviation|Mean
105941|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|Donepezil PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for donepezil (parent compound only) after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||h*ng/mL||Standard Deviation|Mean
105942|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||hours||Standard Deviation|Mean
105943|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|Donepezil PK data; Maximum Concentration (Cmax); i.e, highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||ng/mL||Standard Deviation|Mean
105944|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|EVP-6124 PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||h*ng/mL||Standard Deviation|Mean
105945|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|EVP-6124 PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||hours||Standard Deviation|Mean
105946|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|EVP-6124 PK data; Maximum Concentration (Cmax); i.e, highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.||ng/mL||Standard Deviation|Mean
105947|NCT00766363|Primary|Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer’s Disease|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis)|Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only]|Safety Population: All randomized subjects who ingested at least 1 dose of study drug.||Participants|||Number
105948|NCT00766090|Secondary|Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods|Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population||participants|||Number
105950|NCT00766090|Secondary|Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||millimeters of mercury (mmHg)||Standard Deviation|Mean
105951|NCT00766090|Secondary|Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period|Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.||participants|||Number
105952|NCT00766090|Secondary|24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period|A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.|Day 28 of the relevant treatment period (up to Study Day 112)|Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results||Nanomoles per 24 hours||Geometric Coefficient of Variation|Geometric Mean
105953|NCT00766090|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population||participants|||Number
105954|NCT00766090|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.|Day 28 of the relevant treatment period (up to Study Day 112)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication||Liters||Standard Error|Least Squares Mean
105955|NCT00766051|Secondary|"A Priori H4: A Total Scale Score of Parents' Perception of Infant Easiness (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Easiness Scale measures the parent's perceived efficacy in the areas of infant irritability, sleeping habits, alertness and responsiveness, and difficulty. The Easiness Scale(Wolke [in Brazelton and Nugent], 1995]) was used to determine mother/parent perceptions of their infants' mood and state in the NICU as a result of training in NBOTI. An increasing score denotes an improvement in parent efficacy in their perception of their infant's easiness.uses a Likert scale. There are four questions, ranging from -3-3. The maximum score is 12, and the minimum score is -12.|Upon an infant's entry into the study, and again at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.||Scores on Scale||Standard Deviation|Mean
105956|NCT00766051|Secondary|"A Priori H3: A Total Score of the Parents' Global Confidence (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Global Confidence Scale of The Mother and Baby Scales (Wolke [in Brazelton and Nugent], 1995]) is a total score measure of mother/parent self efficacy in the NICU as a result of training in NBOTI. It is a total score measure of the parent's perceived efficacy of themselves as confidence in the feeding, handling, caretaking, and interactions needed to foster relationships with their infants. An increase in this score denotes an increase in the parent's perception of their global confidence in caring for their infant. Global Confidence Measure uses a Likert scale. There are three questions, ranging from -3-3. The maximum score is 9, and the minimum score is -9.|Upon an infant's entry into the study, and at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.||scores on scale||Standard Deviation|Mean
105957|NCT00766051|Secondary|A Priori H2: The Increase in Oral Feeding Percentage Over Days Was Correlated With Increasing Respiratory Competency During Oral Feeding; Measured as the High Frequency Percentage (HF%) of Intervention Groups' Heart Rate Variability (HRV) During Feeding.|Oral feeding percentage was based upon 150 kc/kg/day. Heart rate data was recorded about once per week during feeding using a Holter monitor connected to the bedside ecg. This data was downloaded in Cardiology, converted to numerical data as HRV by bioengineers at Politecnico di Milano, Italy. As infants reached 100% of oral feedings, heart rate variability data was analyzed to determine the infants' overall trend toward relaxation, measured as increasing High Frequency Percentage (HF %). Hierarchical linear modeling (HLM) (Singer and Willett, 2003) SPSS Grad Pack 17, mixed model analysis.|The time frame was from Baseline until discharge (at or before 20 days).|The intervention group consisted of Four Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, and Two near term infants with Omphalocele. This outcome measured the correlation between the percentage of oral feedings and the percentage of High Frequesncy Heart Rate Variability.||Percentage||Standard Deviation|Mean
105988|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.||percentage|||Number
105958|NCT00766051|Primary|A Priori H1. The Number of Days to Achieve Oral Feeding Between the Intervention Group and the Matched Historical Comparison Group - From All Tube to All Oral Feeding - Was Analyzed.|This outcome measured the number of days it took to go from all tube to all oral feeding or at discharge, whichever came first. Oral feeding percentages were based upon 150 kcal/kg/day. Feeding volumes and weights were taken directly from the nurses notes, and averaged daily. A two sample t-test was used to detect differences between the groups.|The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).|The intervention group and matched historical comparison group consisted of Four pairs of Extremely Preterm to Preterm infants with high risk factors, Three pairs of term or near term infants with Gastroschisis, Two pairs of infants term or near term with Omphalocele, and One pair of infants term age with Congenital Diaphragmatic Hernia.||Days||Standard Deviation|Mean
105959|NCT00765947|Secondary|Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment||24 weeks||||||
105960|NCT00765947|Secondary|Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]|Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).|24 weeks|||Percentage of Participants|||Number
105961|NCT00765947|Secondary|Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]||Baseline and Week 24|Full analysis set||mm Hg||Standard Deviation|Mean
105962|NCT00765947|Secondary|Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks|||Percentage of Participants|||Number
105963|NCT00765947|Primary|Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks|Full analysis set||Percentage of participants|||Number
105964|NCT00765895|Primary|Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits|A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.|at end of treatment, 15 weeks from baseline assessment|intention to treat||participants||95% Confidence Interval|Number
105965|NCT00765882|Secondary|12-Week Constipation Severity|Constipation severity was based on a 5-point ordinal scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 11 additional patients who dropped out prior to finishing 1 week of the trial were excluded from the Constipation Severity endpoint. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
105966|NCT00765882|Secondary|12-Week Bloating|Bloating was based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 1 additional patient without a baseline Bloating score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
105967|NCT00765882|Secondary|12-Week Abdominal Discomfort|Abdominal discomfort is based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe.”|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. 1 additional patient without a baseline Abdominal Discomfort score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
105968|NCT00765882|Secondary|12-Week Severity of Straining|Straining is measured on a 5-point scale, where a value of 1 is “not at all” and a value of 5 is “an extreme amount.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 Patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
105969|NCT00765882|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
105970|NCT00765882|Secondary|12-Week Spontaneous Bowel Movement (SBM) Frequency Rate|A patient’s 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||SBM per week||Standard Error|Least Squares Mean
105972|NCT00765882|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.~A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
105973|NCT00765843|Primary|Heel Pain|Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.|baseline, one month and three months|||score on a survey||Standard Deviation|Mean
105974|NCT00765817|Secondary|Percentage of Subjects Experiencing Minor Hypoglycemia|Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set||percentage|||Number
105975|NCT00765817|Secondary|Minor Hypoglycemia Rate Per Year|Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set||events per subject per year||Standard Deviation|Mean
105976|NCT00765817|Secondary|Change in Diastolic Blood Pressure (DBP)|Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmHg||Standard Error|Least Squares Mean
105977|NCT00765817|Secondary|Change in Systolic Blood Pressure (SBP)|Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmHg||Standard Error|Least Squares Mean
105978|NCT00765817|Secondary|Change in Daily Insulin Dose (on a Per Body Weight Basis)|Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||insulin units per kg (U/kg)||Standard Error|Least Squares Mean
105979|NCT00765817|Secondary|Change in Daily Insulin Dose|Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||insulin units (U)||Standard Error|Least Squares Mean
105980|NCT00765817|Secondary|Change in Waist Circumference|Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||cm||Standard Error|Least Squares Mean
105981|NCT00765817|Secondary|Change in Body Weight|Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||kg||Standard Error|Least Squares Mean
105982|NCT00765817|Secondary|Change in Triglycerides|Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)|baseline and 30 weeks|Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
105983|NCT00765817|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
105984|NCT00765817|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
105985|NCT00765817|Secondary|Change in Total Cholesterol|Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
105986|NCT00765817|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
105987|NCT00765817|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||mmol/L||Standard Error|Least Squares Mean
105989|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.||percentage|||Number
105990|NCT00765817|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.|baseline and 30 weeks|Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis||percentage of hemoglobin||Standard Error|Least Squares Mean
105991|NCT00765765|Primary|Tumor Response Rate|Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase II portion of the ixabepilone plus hydroxychloroquine combination treatment study, a tumor response rate of less than 15% will be deemed uninteresting. The target tumor response rate will be 35%. Due to uncertainty about the true response rate of ixabepilone plus hydroxychloroquine combination on this patient poupation, we also will consider a response rate of 30% to be encouraging.|3 years|The study was closed early due to slow accrual. Insufficient data were collected to evaluate this outcome measure.|||||
105992|NCT00765765|Secondary|Correlation of Estrogen Receptor, Progesterone Receptor and/or HER2 Status With Treatment Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
105993|NCT00765765|Secondary|Effects of Hydroxychloroquine on Autophagy||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
105994|NCT00765765|Secondary|Pharmacodynamic Markers for Autophagy Detection||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
105995|NCT00765765|Secondary|Survival Time||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
105996|NCT00765765|Secondary|Time to Progressive Disease||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
105997|NCT00765765|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.|||||
105998|NCT00765726|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.|Month 24 or early withdrawal|Safety analysis population included all enrolled participants who had taken at least 1 dose of the study medication.||Percentage of participants||95% Confidence Interval|Number
105999|NCT00765674|Secondary|Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)|Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||mmHg||Standard Error|Least Squares Mean
106000|NCT00765674|Secondary|Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)|Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|End of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||Percentage of patients|||Number
106001|NCT00765674|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||mmHg||Standard Error|Least Squares Mean
106002|NCT00765674|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.||mmHg||Standard Error|Least Squares Mean
106108|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106003|NCT00765661|Secondary|Evaluation of Safety and Efficacy of LCP-Tacro Compared to Prograf in Adult de Novo Kidney Transplant Patients.|"To evaluate the efficacy and safety of LCP-Tacro compared to Prograf in the first 12 months after kidney transplantation.~Efficacy was assessed by monitoring biopsy-proven acute rejection (BPAR) according to the Banff criteria, graft failure (defined by a patient starting dialysis for at least 30 days, nephrectomy, retransplantation, or death with a functioning graft), patient survival, and renal function based on serum creatinine and glomerular filtration rate (GFR), based on serum creatinine, serum urea nitrogen, and serum albumin."|12 months|All patients receiving at least one dose of study drug was included in the safety evaluation.||participants|||Number
106004|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.||ng*hr/mL||Standard Deviation|Mean
106005|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.||ng/mL||Standard Deviation|Mean
106006|NCT00765661|Primary|Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.|Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation|14 days|||percentage of patients|||Number
106007|NCT00765648|Secondary|Transition Time to Oral Medication|The median transition time (in hours) to oral medication|6 hours|these are the correct participant numbers for this secondary analysis||hours||Inter-Quartile Range|Median
106008|NCT00765648|Secondary|Subjects Requiring the Use of Intravenous Rescue Medications|The percent of subjects requiring the use of intravenous rescue medications|6 hours|||percentage of participants|||Number
106009|NCT00765648|Secondary|Treatment Failure|Treatment failure is defined as admission to the hospital or observation unit for BP management|6 hours|these are the correct participant numbers for this secondary analysis||percentage of participants|||Number
106010|NCT00765648|Secondary|Emergency Department(ED)Time to Disposition Decision|Median number of hours from hospital admission until Emergency Department(ED)disposition|6 hours|these are the correct participant numbers for this secondary analysis||hours||Inter-Quartile Range|Median
106011|NCT00765648|Secondary|Average Number of Dose Titrations Within 30 Minutes|Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group|30 minutes|||number of titrations||Standard Deviation|Mean
106012|NCT00765648|Primary|Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.|Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.|30 minutes after initiation of therapy|Intent to treat cohort.||percentage of participants|||Number
106013|NCT00765570|Secondary|Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.|Complete response (CR) = 100% tumor disappearance Partial response (PR) = > 50% reduction in size Stable disease (SD) = < 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = > 10% increase in size of tumor Unknown Status (UK)|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.|||participants|||Number
106014|NCT00765570|Primary|Protocol Treatment Related Morbidity|Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.|||events|||Number
106015|NCT00765388|Secondary|Changes in Skin Compared to Before Study|The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product|4 weeks|ITT population||Participants|||Number
106016|NCT00765388|Secondary|Bag Twisting During Night|The patient was asked if he/she noticed whether the bag twisted during night|4 weeks|ITT population||Participants|||Number
106017|NCT00765388|Secondary|Problems With Splashing Sounds During Use|The patient was asked whether he/she noticed any splashinh sounds during use|4 weeks|ITT population||Participants|||Number
106018|NCT00765388|Secondary|Feeling of Security During the Night|The patients feeling of security with the product during the night|4 weeks|ITT population||Participants|||Number
106019|NCT00765388|Secondary|Feeling of Security During the Day|The patients feeling of security with the bag during the day|4 weeks|ITT population||Participants|||Number
106020|NCT00765388|Secondary|Awareness of the Presence of the Product|Evaluates the patients awareness of the presence of the product during use.|4 weeks|ITT population||Participants|||Number
106021|NCT00765388|Secondary|Flexibility of the Product|Evaluation of the ability of the bag to conform with the patients movements (flexibility)|4 weeks|ITT population||Participants|||Number
106022|NCT00765388|Secondary|Adhesives Ability to Absorb Perspiration|Evaluation of the adhesives ability to absorb perspiration from the skin|4 weeks|ITT population||Participants|||Number
106023|NCT00765388|Secondary|Adhesion of the Bag During Use|Evaluation of the adhesion of the base plate around the stoma during use|4 weeks|ITT population||Participants|||Number
106024|NCT00765388|Secondary|Removal of the Bag|How easy/difficult it was to remove the bag|4 weeks|ITT population||Participants|||Number
106025|NCT00765388|Secondary|Immediate Adhesion|Evaluation of immediate adhesion after each period|4 weeks|Intention to treat (ITT)||Participants|||Number
106026|NCT00765388|Primary|Preference of Sensura vs Moderma|Subjects were asked which of the tested products they preferred; SenSura or Moderma.|4 weeks|||percentage of prefering the product|||Number
106027|NCT00765375|Primary|Change in Mean Lesion Count From Baseline at 90 Days|To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)|90 days|All subjects completing Day 90 visit||Lesions||Standard Deviation|Mean
106028|NCT00765362|Primary|Knee Society Scores Used as Success/Failure Criteria.|The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.||Percentage of Participants with Success|||Number
106029|NCT00765362|Primary|Knee Society Function Score|The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.||Average Knee Function Score||Standard Deviation|Mean
106030|NCT00765362|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.||Average Knee Rating Score||Standard Deviation|Mean
106031|NCT00765336|Primary|Mean Percent Change From Screening in Sperm Concentration.||Baseline and 12 Weeks|The enrollment was designed to ensure study completion of approximately 150 subjects. Actual enrollment was 180 subjects (92 in the minocycline group, 88 in the placebo group). A total of 145 subjects (72 in the minocycline group, 73 in the placebo group) comprised the completed population group.||Percent change||Standard Deviation|Mean
106032|NCT00765245|Other Pre-specified|Exploratory: Concordance Between IHC for GCB and Non-GCB Subtypes to the Gene Expression Profiles Associated With the Subtypes||up to two years||||||
106033|NCT00765245|Other Pre-specified|Investigate Potential Predictive Biomarkers of Clinical Response or Resistance to Lenalidomide||up to two years||||||
106034|NCT00765245|Secondary|Number of Patients With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death. Toxicities present at baseline and continuing without change in grade are excluded when considering worst‐grade toxicity.|30 days after completing treatment, for up to 13 months|Total number of patients reported with any toxicity||participants|||Number
106035|NCT00765245|Secondary|Disease-free Survival at 2 Years|Disease-free survival is the estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method where death is an event, with censoring for non‐expired patients at last known date alive.|From on-treatment date to disease recurrence, up to 2 years|||years||95% Confidence Interval|Median
106036|NCT00765245|Primary|Disease-free Survival at 1 Year|Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Those who are alive and without relapse are censored at the last date known alive.|From on-treatment date to disease recurrence, up to 1 year|||years||95% Confidence Interval|Mean
106037|NCT00765232|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery|||mg||Standard Deviation|Mean
106038|NCT00765232|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery|||units on a scale||Standard Deviation|Mean
106039|NCT00765206|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days|||pH scale||Full Range|Median
106040|NCT00765193|Secondary|Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.||one year||||||
106041|NCT00765193|Primary|Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.||one year|From a population of patients with various skin conditions, participants were considered for inclusion only if aged 18 years or more, and if suffering from focused skin complaints. Patients with diffuse skin complaints were excluded.||participants|||Number
106042|NCT00765128|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery|||mg||Standard Deviation|Mean
106043|NCT00765128|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery|||units on a scale||Standard Deviation|Mean
106044|NCT00765102|Secondary|Kaplan Meier Estimates for Overall Survival|Overall survival is the time from initiation of therapy to death from any cause.|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
106069|NCT00765076|Secondary|Haemagglutinin Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.|At Day 0, 21, 42 and 180|The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
117313|NCT00670462|Secondary|Insulin||baseline, 6, 12, 18, and 30 months||||||
106045|NCT00765102|Secondary|Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator|"Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
106046|NCT00765102|Secondary|Kaplan Meier Estimate for Duration of Response Assessed by the Investigator|"Duration of response is defined as the time from first response to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
106047|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Response Assessed by the Investigator|"The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response).~Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.|||||
106048|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Progression Assessed by the Investigator|"Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. Analysis was not performed due to early termination of the study.|||||
106049|NCT00765102|Secondary|Total Volume of Distribution (Vz)|Total volume of distribution of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||L||Geometric Coefficient of Variation|Geometric Mean
106050|NCT00765102|Secondary|Total Clearance (CL)|Total clearance of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||L/hr||Geometric Coefficient of Variation|Geometric Mean
106051|NCT00765102|Secondary|Terminal Half-life (t1/2)|Terminal half-life of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||hr||Geometric Coefficient of Variation|Geometric Mean
106052|NCT00765102|Secondary|Time to Maximum Observed Concentration (Tmax)|Time to maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||hr||Full Range|Median
106053|NCT00765102|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
106054|NCT00765102|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0–∞)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
106055|NCT00765102|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.|up to 9 months|Safety population of participants who took at least one dose of drug.||participants|||Number
106100|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
110001|NCT00733421|Secondary|Compliance to Base Medication|Number of patients that did not discontinue study medication before day 7|7-day study period, during study medication|||patients|||Number
106056|NCT00765102|Primary|Count of Participant Best Overall Response As Assessed by the Investigator|"Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other.~Stable Disease: Less than MR, but not PD~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia."|up to 8 months|Intent-to-Treat (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study.|||||
106057|NCT00765076|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106058|NCT00765076|Secondary|Number of Subjects Reporting Any AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106059|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106060|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106061|NCT00765076|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.||Days||Full Range|Median
106062|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106063|NCT00765076|Secondary|Duration of Solicited Local AEs|Duration was defined as the number of days with any grade of local symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.||Days||Full Range|Median
106064|NCT00765076|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106065|NCT00765076|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||subjects|||Number
106066|NCT00765076|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||fold increase||95% Confidence Interval|Geometric Mean
106067|NCT00765076|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||subjects|||Number
106068|NCT00765076|Secondary|The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||subjects|||Number
106070|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
106071|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
106072|NCT00765076|Primary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)|Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group.||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
106073|NCT00765063|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
106074|NCT00765063|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant’s pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.||Units on a scale||Standard Deviation|Mean
106075|NCT00765063|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||Participants|||Number
106076|NCT00765063|Secondary|Time to First Amputation||Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||Months||95% Confidence Interval|Median
106077|NCT00765063|Secondary|Time to Intact Skin Healing|Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||Months||95% Confidence Interval|Median
106078|NCT00765063|Secondary|Number of Participants Who Underwent Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.||Participants|||Number
106079|NCT00765063|Secondary|Number of Participants With Improved Ulcer Healing|Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.||Participants|||Number
106080|NCT00765063|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.|Baseline through Week 24 (EOT) or ET|Intent to treat (ITT) population included all participants who were enrolled into the study.||Participants|||Number
106081|NCT00765063|Primary|Number of Trivial Hemorrhages|Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
106082|NCT00765063|Primary|Number of Clinically Relevant Minor Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
106083|NCT00765063|Primary|Number of Minor Hemorrhages|Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
106084|NCT00765063|Primary|Number of Major Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
106085|NCT00765063|Primary|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||Hemorrhages|||Number
106086|NCT00765037|Primary|Survivorship of the Encore Reverse Shoulder Prosthesis|Number of subjects who completed all study visits through the 1 year visit.|1 year|||participants|||Number
106087|NCT00764946|Primary|Number of Participants Who Discontinued Due to an Adverse Event|Numbers of participants who discontinued due to an adverse event were summarized by race.|Week 48|||Participants|||Number
106088|NCT00764946|Primary|Number of Participants With One or More Adverse Events|Numbers of participants with one or more adverse events were summarized by race.|Week 48|||Participants|||Number
106089|NCT00764946|Secondary|Number of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.||participants|||Number
106090|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count|Mean changes from baseline in CD4 cell counts were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."||cells/mm^3||95% Confidence Interval|Mean
106091|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in HIV RNA|Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."||log10 copies/mL||95% Confidence Interval|Mean
106092|NCT00764946|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.||Participants|||Number
106093|NCT00764946|Primary|Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.|Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.~The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values."||Participants|||Number
106094|NCT00764881|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106095|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106096|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106097|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106098|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106099|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
107313|NCT00756977|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent"|2-day|||percentage of participants||95% Confidence Interval|Number
106109|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106110|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106111|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106112|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106113|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106114|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106115|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106116|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106117|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106118|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106119|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106120|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106121|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106122|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106123|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106124|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106125|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106126|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
117314|NCT00670462|Secondary|Blood Glucose||baseline, 6, 12, 18, and 30 months||||||
106128|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106129|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106130|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106131|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
106132|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
106133|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106134|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106135|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106136|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106137|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106138|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106139|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106140|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106141|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
106142|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||episodes||Standard Deviation|Mean
106143|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 2|Reference Period 2 is defined as Day 91 to 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106144|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 1|Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.||Days||Standard Deviation|Mean
106145|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106146|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106147|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Baseline|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106148|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106149|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106150|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106151|NCT00764881|Secondary|Vaginal Effects Evaluated by Vaginal pH at Cycle 6|Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Proportion of participants|||Number
106152|NCT00764881|Secondary|Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106153|NCT00764881|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Percentage of participants|||Number
106154|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Vitality|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106155|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Cycle 6|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106156|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Baseline|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106157|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – General Health|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106158|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Cycle 6|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106159|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Baseline|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106160|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Self-control|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106191|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6|Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106161|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Cycle 6|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106162|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Baseline|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106163|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Positive Well-being|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106164|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Cycle 6|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106165|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Baseline|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106166|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Depressed Mood|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106167|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Cycle 6|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106168|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Baseline|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106169|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Anxiety|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106170|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Cycle 6|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106171|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Baseline|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106172|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score|Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106173|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6|The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
107527|NCT00754624|Primary|Annual Rate of Change in FEV1 From Baseline to End of Study||Baseline to 48 months|Safety Population defined as all subjects who received at least one dose of study drug||Liters per year||Standard Error|Mean
106174|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline|The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Baseline|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
106175|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106176|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6|Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106177|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline|Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106178|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score|Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106179|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106180|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106181|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Total Score|The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106182|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Cycle 6|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106183|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Baseline|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Baseline|FAS||scores on a scale||Standard Deviation|Mean
106184|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)|Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106185|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106186|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106187|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)|Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106188|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6|Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106189|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline|Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106190|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)|Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106192|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline|Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106193|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)|Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||Scores on a scale||Standard Deviation|Mean
106194|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
106195|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||Scores on a scale||Standard Deviation|Mean
106196|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)|Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
106197|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6|Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
106198|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline|Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS||scores on a scale||Standard Deviation|Mean
106199|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)|Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
106200|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
106201|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Baseline|FAS||scores on a scale||Standard Deviation|Mean
106202|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Per Protocol Set (PPS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|Per Protocol Set (PPS) includes those participants of the FAS without major protocol deviations affecting the primary variables||scores on a scale||Standard Deviation|Mean
106203|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Full Analysis Set (FAS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.||scores on a scale||Standard Deviation|Mean
106204|NCT00764868|Secondary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and Up to 52 weeks|FAS||Units on a scale||Standard Deviation|Mean
106205|NCT00764868|Secondary|Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 52 weeks|FAS||Percent of participants|||Number
106206|NCT00764868|Primary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 52 weeks|Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.||Units on a scale||Standard Deviation|Mean
106207|NCT00764790|Secondary|Number of Subjects Reporting Rare Serious Events|Rare serious events have an occurrence rate of 1/300 (0.3%).|During the entire study (Day 0 until Month 6)|||subjects|||Number
106208|NCT00764790|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.~NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders"|During the entire study (Day 0 until Month 6)|||subjects|||Number
107528|NCT00754572|Secondary|Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.|||||
106209|NCT00764790|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During a 28-day follow-up period after vaccination|||subjects|||Number
106210|NCT00764790|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.||subjects|||Number
106211|NCT00764790|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.||subjects|||Number
106212|NCT00764790|Secondary|Seroconversion Factor|"Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity||fold increase||95% Confidence Interval|Mean
106213|NCT00764790|Secondary|Number of Seroprotected Subjects|"A seroprotected subject is a subject with a serum anti-HA titer~≥ 1:40~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity||subjects|||Number
106214|NCT00764790|Primary|Number of Subjects Who Seroconverted|"Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity||subjects|||Number
106215|NCT00764790|Primary|Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains|"GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||titre||95% Confidence Interval|Geometric Mean
106216|NCT00764673|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|All subjects in the study were evaluated for adverse events.||Events|||Number
106217|NCT00764673|Primary|Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.|Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.|2-year|The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.||participants|||Number
106218|NCT00764673|Secondary|Oxford Knee Score|Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.|2-year|The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.||Units on a scale||Standard Deviation|Mean
106219|NCT00764673|Primary|Knee Society Function Score|The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.|2-year|The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.||Average Knee Function Score||Standard Deviation|Mean
106220|NCT00764673|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|The number of subjects who completed their 2 year visit.||Average Knee Rating Score||Standard Deviation|Mean
106221|NCT00764660|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 12 weeks|The APT population consisted of all participants who received at least one dose of study drug.||Participants|||Number
106222|NCT00764660|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 16 weeks|The All-Participants-Treated (APT) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
106223|NCT00764660|Secondary|Change From Baseline in Mood VAS Score|Participants were asked to answer the question: “Over the past week, how did you feel?” The 100 mm line of the VAS was anchored on the left by “Extremely bad” and on the right by “Extremely good”. Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
106237|NCT00764504|Primary|"Neer's Limited Goals"|To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||participants|||Number
106224|NCT00764660|Secondary|Change From Baseline in Motivation VAS Score|Participants were asked to answer the question: “Over the past week, how motivated were you to stay alcohol abstinent?” The 100 mm line of the VAS was anchored on the left by “No motivation at all” and on the right by “Extremely motivated”. Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
106225|NCT00764660|Secondary|Change From Baseline in Craving Visual Analog Scale (VAS) Score|Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: “Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?” The 100 mm line of the VAS was anchored on the left by “No desire at all” and on the right by “Extreme desire”. Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||95% Confidence Interval|Least Squares Mean
106226|NCT00764660|Secondary|Global Functioning: CGI - Therapeutic Effect|The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||Standard Deviation|Mean
106227|NCT00764660|Secondary|Global Functioning: Clinical Global Impression (CGI) - Severity of Illness|The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Score on a Scale||Standard Deviation|Mean
106228|NCT00764660|Secondary|Percentage of Participants With Complete Abstinence|Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Percentage of Participants|||Number
106229|NCT00764660|Secondary|Percentage of Abstinent Days|Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Percentage of Days||95% Confidence Interval|Least Squares Mean
106230|NCT00764660|Secondary|Time to First Relapse Into Drinking|Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Days||Standard Deviation|Mean
106231|NCT00764660|Secondary|Number of Lapses Into Any Drinking|An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Lapses||Standard Deviation|Mean
106232|NCT00764660|Secondary|Number of Relapses Into Heavy Drinking|An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Relapses||Standard Deviation|Mean
106233|NCT00764660|Secondary|Number of Drinks Per Drinking Day|The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with ‘day’ being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.||Drinks||95% Confidence Interval|Least Squares Mean
106234|NCT00764660|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use.~A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol).~Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval."|12 weeks|The modified Intent-to-Treat (mITT) population consisted of all participants from the All-Participants-Treated (APT) population who had at least post randomization efficacy data for this outcome measure.||Percentage of Days||95% Confidence Interval|Least Squares Mean
106235|NCT00764504|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.||adverse events|||Number
106236|NCT00764504|Primary|Radiographic Failures|Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.|Post-operative, 3-month, 6-month, 1-year, 2-year|Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.||participants|||Number
109543|NCT00736099|Secondary|Number of Patients With HbA1c<7.0% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||participants|||Number
106238|NCT00764504|Primary|Have Surgery Again?|Subject satisfaction: subject's willingness to have surgery performed again if necessary.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||participants|||Number
106239|NCT00764504|Primary|Subject Satisfaction With Surgery|Each subject had a chance to rate their satisfaction with surgery at each study interval.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||participants|||Number
106240|NCT00764504|Primary|Average Range of Motion|Physician's assessment of a subject's range of motion in degrees.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||Angle of Degrees of Shoulder Motion||Standard Deviation|Mean
106241|NCT00764504|Primary|American Shoulder and Elbow Surgeons Shoulder Score|"The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:~[(10 – Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]"|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.||Units on a scale||Standard Deviation|Mean
106242|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score sums the scores from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106243|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score sums the score from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106244|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106245|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106246|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score sums the scores from all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106247|NCT00764478|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale sums the scores from all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106278|NCT00763971|Secondary|Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 7 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
109544|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 78||Baseline and week 78|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
106248|NCT00764478|Secondary|Change From Baseline in PANSS Positive Subscale Score|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106249|NCT00764478|Secondary|Change From Baseline in PANSS Negative Subscale Score|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106250|NCT00764478|Secondary|Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score sums the scores from all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106251|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score|The CGI-BP-I depression is a score on a 7-point scale for assessing the change from preceding phase of depression symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I depression score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
106252|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score|The CGI-BP-I mania is a score on a 7-point scale for assessing the change from preceding phase of mania symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I mania score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
106253|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score|The CGI-BP-I overall is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I overall score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
106254|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Depression Score|The CGI-BP-S depression is a score that assesses the severity of the depression component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Score on a scale||Standard Error|Least Squares Mean
106255|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Mania Score|The CGI-BP-S mania is a score that assesses the severity of the mania component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint. One participant from the Placebo BID arm missed a baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106256|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106297|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106257|NCT00764478|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS measures depression and consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score sums the scores from the 10 items, ranging from 0 to 60, with a higher numeric rating implying a greater degree of symptom severity. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7 and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Score on a scale||Standard Error|Least Squares Mean
106258|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a generalized linear mixed model (GLMM). Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 2, Day 4, Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
106259|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement.||Percentage of participants|||Number
106260|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.||Percentage of participants|||Number
106261|NCT00764478|Secondary|Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7 and Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106262|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Percentage of participants|||Number
106263|NCT00764478|Secondary|Change From Baseline in Clinical Global Impression – Bipolar Mania – Severity of Illness (CGI-BP-S) Overall Score at Day 21|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106264|NCT00764478|Primary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.||Score on a scale||Standard Error|Least Squares Mean
106275|NCT00764309|Primary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||Participants|||Number
106276|NCT00763971|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.|Up to 7 weeks|Safety Population||participants|||Number
117315|NCT00670462|Secondary|Waist-to-hip Ratio at Baseline||baseline|||ratio||Standard Error|Mean
106265|NCT00764465|Primary|AUC: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng•h/mL||90% Confidence Interval|Mean
106266|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng/mL||90% Confidence Interval|Mean
106267|NCT00764465|Secondary|Number of Participants Who Experienced an Adverse Event|"Safety/tolerability data collected included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~MVC 300mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with MVC 300mg BID~FPV 700mg/RTV 100 mg BID combined with MVC 300mg BID~FPV 1400mg/RTV 100mg QD combined with MVC 300mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004"|Day 0 through Day 49|||participants|||Number
106268|NCT00764465|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens|||ng•h/mL||90% Confidence Interval|Mean
106269|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens|||ng/mL||90% Confidence Interval|Mean
106270|NCT00764361|Secondary|Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)||baseline, week 4, week 10, week 20||||||
106271|NCT00764361|Primary|Number of Participants Without Adverse Events|Participants were monitored for 20 weeks during the study.|every 2 weeks|||participants|||Number
106272|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR)|GR0=normal,1=mild,2=moderate,3=severe,4=life-threatening. ALP(U/L) GR0:40-135,GR1:>135-337; ALT(U/L) GR0:0-47,GR1:>47-117; AST(U/L) GR0:0-37,GR1:>37-93; High(↑) Calcium(mg/dL) GR0:8.4-10.2,GR1:>10.2-11.5; Low(↓) Calcium(mg/dL) GR0:8.4-10.2,GR1:<8.4-8.0,GR2:7.0-<8.0; CK(U/L) GR0:24-195,GR1:>195-488, GR2:>488-975; Creatinine(mg/dL) GR0:0.6-1.4,GR1:>1.4-2.1,GR2:>2.1-4.2; ↑Potassium(mEq/L) GR0:3.6-5.2,GR1:>5.2-5.5,GR2:>5.5-6.0; ↑Sodium(mEq/L) GR0:134-146; ↓Sodium(mEq/L) GR0:134-146,GR1:<134-130; Inorganic Phosphorus(mg/dL) GR0:2.4-4.9,GR2:≥2.0-<2.5; Total Bilirubin(mg/dL) GR0:0-1.1,GR1:>1.1-2.75.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||participants|||Number
106273|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Hematology|Toxicity was graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. (Grade (GR)0=normal, GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening). Granulocyte count (x 10^9 /L), GR1: ≥1.0 - <1.5, GR2: ≥0.5 - <1.0; Hemoglobin (g/dL), GR0: 13-17, GR1: <13 - 10.0 , GR2: 8.0 - <10.0, GR3: 6.5 - <8.0; Platelet count (x 10^9 /L) GR0: 150-400, GR2: ≥50.0 - <75.0; Leukocyte count (x 10^9 /L ), GR0: 3.5-11.1, GR2: 2.0 - <3.0.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||participants|||Number
106274|NCT00764309|Primary|Reasons for Discontinuation of Study Treatment|"Participants who discontinued the study due to any AEs were recorded.~Significant drug-related discontinuations were those SAEs recorded on the SAE case report forms with relationship to study drug of related or missing and action taken regarding study drug of discontinued or missing."|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.||Participants|||Number
106277|NCT00763971|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 7 weeks|Safety Population defined as all subjects who took at least 1 dose of investigational product.||Scores on a scale||Standard Deviation|Mean
106279|NCT00763971|Secondary|Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline and up to 7 weeks|FAS||T-scores||Standard Error|Least Squares Mean
106280|NCT00763971|Secondary|Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 7 weeks|FAS||Scores on a scale||Standard Deviation|Mean
106281|NCT00763971|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 7 weeks|FAS||Scores on a scale||Standard Error|Least Squares Mean
106282|NCT00763971|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 7 weeks|FAS||percentage of participants|||Number
106283|NCT00763971|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and up to 7 weeks|Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.||Scores on a scale||Standard Error|Least Squares Mean
106284|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.|Number of participants with positive opiate urine sample at the 24 week follow-up.|24 weeks|All subjects were included in the analysis population as intent to treat.||participants|||Number
106285|NCT00763958|Secondary|Number of Participants Who Enroll in the Study.|To determine the number of participants who enroll in the study during the time of recruitment.|up to 24 months|||participants|||Number
106286|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.|Number of participants with positive opiate urine samples at 12 weeks of treatment.|12 weeks|All subjects were included in the analysis population as intent to treat.||participants|||Number
106287|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106288|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106289|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106290|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106291|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106292|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106293|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106294|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106295|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106296|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
117316|NCT00670462|Secondary|Blood Pressure||baseline, 6, 12, 18, and 30 months||||||
106298|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106299|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106300|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106301|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106302|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106303|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106304|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106305|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106306|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.||units on a scale||Standard Error|Mean
106307|NCT00763919|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106308|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106309|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.||units on a scale||Standard Error|Mean
106310|NCT00763867|Other Pre-specified|Furosemide-Equivalent Dose||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
106311|NCT00763867|Other Pre-specified|Galectin 3||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL||Standard Deviation|Mean
106312|NCT00763867|Other Pre-specified|Cyclic Guanosine Monophosphate (cGMP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pmol/mL||Standard Deviation|Mean
106313|NCT00763867|Other Pre-specified|Collagen Type I (CITP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
106314|NCT00763867|Other Pre-specified|High Sensitivity C-Reactive Protein||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
106315|NCT00763867|Other Pre-specified|Endothelin-1||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
106316|NCT00763867|Other Pre-specified|Procollagen III N-terminal Peptide||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
106317|NCT00763867|Other Pre-specified|High Sensitivity Troponin I||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
106318|NCT00763867|Other Pre-specified|Aldosterone||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
106319|NCT00763867|Other Pre-specified|N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
106320|NCT00763867|Other Pre-specified|Uric Acid||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
106321|NCT00763867|Other Pre-specified|Cystatin C||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
106322|NCT00763867|Other Pre-specified|Best Available Glomerular Filtration Rate (GFR)|Best available=local lab results when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min/1.73m^2||Standard Deviation|Mean
106323|NCT00763867|Other Pre-specified|Best Available Creatinine|Best available=local lab results only when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
106324|NCT00763867|Other Pre-specified|ECHO Pulmonary Artery Systolic Pressure|A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mmHg||Standard Deviation|Mean
106325|NCT00763867|Other Pre-specified|MRI Aortic Distensibility|An increase in Aortic Distensibility is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||cm^2*dyne-1||Standard Deviation|Mean
106326|NCT00763867|Other Pre-specified|MRI Aortic Thickness|A decrease in Aortic Thickness is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mm||Standard Deviation|Mean
106327|NCT00763867|Other Pre-specified|MRI Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Woods units||Standard Deviation|Mean
106328|NCT00763867|Other Pre-specified|MRI Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Farads-1||Standard Deviation|Mean
106329|NCT00763867|Other Pre-specified|ECHO Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Woods units||Standard Deviation|Mean
106330|NCT00763867|Other Pre-specified|ECHO Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||Farads-1||Standard Deviation|Mean
106331|NCT00763867|Other Pre-specified|Lateral Filling Pressure|A decrease in lateral filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
106332|NCT00763867|Other Pre-specified|Medial Filling Pressure|A decrease in medial filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
106333|NCT00763867|Other Pre-specified|Lateral Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
106334|NCT00763867|Other Pre-specified|Medial Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||m/sec||Standard Deviation|Mean
106335|NCT00763867|Other Pre-specified|Lateral Diastolic Elastance|A decrease in Lateral Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||(m/sec)/cc||Standard Deviation|Mean
106336|NCT00763867|Other Pre-specified|Medial Diastolic Elastance|A decrease in Medial Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||(m/sec)/cc||Standard Deviation|Mean
106337|NCT00763867|Other Pre-specified|Echocardiogram Left Ventricular Mass|A decrease in Left Ventricular Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||gm||Standard Deviation|Mean
106338|NCT00763867|Other Pre-specified|MRI Left Ventricular Ejection Fraction (LVEF)|An increase in LVEF is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||percentage of volume||Standard Deviation|Mean
106339|NCT00763867|Other Pre-specified|MRI Left Ventricular End Systolic Volume Index|An increase in Left Ventricular End Systolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/m^2||Standard Deviation|Mean
106340|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume Index|An increase in Left Ventricular End Diastolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/m^2||Standard Deviation|Mean
106341|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume|An increase in Left Ventricular End Diastolic Volume is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
106342|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass Index|A decrease in Left Ventricular Mass Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||gm/m^2||Standard Deviation|Mean
106343|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass|A decrease in LV Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||gm||Standard Deviation|Mean
106389|NCT00763282|Secondary|Mean Number of Skin-related Admissions|Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.|Discharge to end of study (6 months)|Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)||admissions/participant||Standard Deviation|Mean
106344|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire|The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
106345|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHFQ)|"The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.~Total score: 0 – 105 Physical subscore: 0 – 40 Emotional subscore: 0 – 25"|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
106346|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
106347|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
106348|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||minutes||Standard Deviation|Mean
106349|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||minutes||Standard Deviation|Mean
106350|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 minute walk distance|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||meters||Standard Deviation|Mean
106351|NCT00763867|Secondary|Composite Score Reflective of Clinical Status|"Participants ranked sequentially with ranking stratified in one of three tiers based on:~Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.~Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.~Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)~The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)"|Measured at Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
106352|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 Minute Walk Distance|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||meters||Standard Deviation|Mean
106353|NCT00763867|Secondary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
106354|NCT00763867|Primary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ml/min/kg||Standard Deviation|Mean
106355|NCT00763815|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
106356|NCT00763815|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
106405|NCT00763139|Primary|Homeostasis Model Assessment (HOMA) for Insulin Sensitivity|Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose * Insulin/22/5|Measured after 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
106357|NCT00763815|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
106358|NCT00763815|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||% of normal beta cells function||Standard Error|Least Squares Mean
106359|NCT00763815|Secondary|Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
106360|NCT00763815|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
106361|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPI assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
106362|NCT00763815|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
106363|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
106364|NCT00763815|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
106365|NCT00763750|Primary|Number of Patients Assessed for Toxicity According to CTC Version 3.0||Throughout the entire study until patient is removed from study an average of 6 weeks|||participants|||Number
106366|NCT00763698|Primary|Left Ventricular Bipolar Pacing Capture Threshold (Volts)|The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.|3 months|This effectiveness endpoint was carried out on the first 16 patients who had a LV lead bipolar pacing capture threshold measurement at 3 months at 0.5 ms pulse width. This patient cohort is referred to as the “Primary Pacing Capture Threshold Patient Cohort”.||volts||Standard Deviation|Mean
106367|NCT00763698|Primary|Percentage of Successful Left Ventricular Lead Implants|Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.|3 months|All patients with an implant or attempted implant were included in the analysis.||percentage of participants||95% Confidence Interval|Number
106368|NCT00763698|Primary|Freedom From Left Ventricular Lead-related Complications|A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.|3 months|Analysis was conducted on the 81 patients with a successful left ventricular lead implant.||percent of participants||95% Confidence Interval|Number
106369|NCT00763490|Secondary|Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)|"The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated.~Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea)."|Up to 5 years|||percentage of patients||95% Confidence Interval|Number
106370|NCT00763490|Secondary|Cumulative Incidence of Neutrophil and Platelet Engraftment|The failure to achieve a neutrophil count > 500/uL or a platelet count >30.0 x 10e9 /L within 35 days of the stem cell infusion will be defined as primary engraftment failure.|Day 35|||percentage of participants||95% Confidence Interval|Number
106371|NCT00763490|Secondary|Percentage of Patients Alive at the End of the Trial|Event Free Survival (EFS) was determined. Patients were followed up to 5 years (median time of 2.35 years).|5 Years|||percentage of patients||95% Confidence Interval|Number
106372|NCT00763490|Primary|Percentage of Participants Alive at 1 Year After Transplant|One-year survival rate after transplant|1 year|||percentage of participants||95% Confidence Interval|Number
106373|NCT00763451|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks|"Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||participants|||Number
106374|NCT00763451|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
106375|NCT00763451|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|"mITT population. The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
106376|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
106377|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||percentage of participants|||Number
109545|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 66||Baseline and week 66|Treated Set with values for HbA1c at baseline and week 66. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
106378|NCT00763451|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"||kilogram||Standard Error|Least Squares Mean
106379|NCT00763451|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.The Placebo (Two-step Titration)andPlacebo (One-step Titration)Arms/Groups were combined as pre-specified in the study protocol"||mmol/L||Standard Error|Least Squares Mean
106380|NCT00763451|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.~The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
106381|NCT00763386|Secondary|Return to Function (RtF) Via Knee Society Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|6 Weeks to 2 Years Post-op, based on on the intervals listed|||units on a scale||Standard Deviation|Mean
106382|NCT00763386|Primary|Postoperative Range of Motion (ROM)|Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.|6 Weeks to 2 Years Post-op, based on on the intervals listed|Analysis was determined by calculating the measurements of the enrolled cases who completed the stated visit interval.||degrees||Standard Deviation|Mean
106383|NCT00763360|Secondary|Corneal Clarity|Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.|2 weeks|Data from subjects for whom this evaluation was not performed is not included in this analysis.||units on a scale|||Number
106384|NCT00763360|Secondary|Change in Corneal Thickness|Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.|1 month|Subjects that did not have both baseline and 1 month values were not included in this analysis.||millimeters||Standard Deviation|Median
106385|NCT00763360|Primary|Investigator Reported Space Maintenance|"Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: Full Chamber Maintained, Working Space Maintained, Shallow, Flat. Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion."|During surgical procedure|||participants|||Number
106386|NCT00763360|Primary|Endothelial Cell Count Change From Baseline|Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.|one month|Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.||Percent change from baseline||Standard Deviation|Mean
106387|NCT00763321|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant’s sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.||scores on a scale||Standard Error|Least Squares Mean
106388|NCT00763321|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).||scores on a scale||Standard Error|Least Squares Mean
110747|NCT00727636|Primary|Antibody Titer to HPV 11||Month 7|Number of participants who completed all vaccine doses||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
106390|NCT00763282|Primary|Skin Status|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|Admission (Baseline), 3 months, 6 months|||participants|||Number
106391|NCT00763282|Primary|Any Skin Worsening|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|6 months|||participants|||Number
106392|NCT00763282|Primary|Skin Behavior Change|"Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms.~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months|||% Change||Standard Deviation|Mean
106393|NCT00763282|Primary|Percent of Possible Self-Reported Skin Care Behaviors|"Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline).~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months|||% of Possible Self-Reported Behaviors||Standard Deviation|Mean
106394|NCT00763269|Secondary|Air Blast Hypersensitivity (8 Week)|"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth."|8 weeks|||units on a scale||Standard Deviation|Mean
106395|NCT00763269|Secondary|Air Blast Hypersensitivity (4 Week)|Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:“0”No subject response to stimulus“1”responds but will continue“2”responds and moves or requests discontinuation“3”Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.|4 weeks|||units on a scale||Standard Deviation|Mean
106396|NCT00763269|Primary|Hypersensitivity Tactile (Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|8 weeks|||Units on a scale||Standard Deviation|Mean
106397|NCT00763269|Primary|Hypersensitivity Tactile(Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|4 weeks|||units on a scale||Standard Deviation|Mean
106398|NCT00763256|Primary|P. Gingivalis|Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.|12 months|||Pg/ng DNA||Inter-Quartile Range|Median
106399|NCT00763256|Primary|Gingivitis Score (GI)|"Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|12 months|||Units on a scale||Standard Deviation|Mean
106400|NCT00763256|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months|||nmol/L||Standard Deviation|Mean
106401|NCT00763256|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months|||mg/L||Standard Deviation|Mean
106402|NCT00763256|Primary|HbA1c Levels in Blood|Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months|||Percentage||Standard Deviation|Mean
106403|NCT00763139|Secondary|ESR|sed rate|baseline and after 8 weeks on either placebo or pioglitazone|||mm/hr||Standard Deviation|Mean
106404|NCT00763139|Secondary|C-reactive Protein (CRP)||Measured after 8 weeks of treatment|||mg/dl||Standard Deviation|Mean
107723|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
106406|NCT00763139|Primary|Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)|A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH|Measured after 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
106407|NCT00763061|Secondary|Mean IOP Change at 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 4 PM|||mmHg||Standard Deviation|Mean
106408|NCT00763061|Primary|Week 12 - Mean IOP At 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At the 4 PM time point for the patient's worse eye.|||mmHg||Standard Deviation|Mean
106409|NCT00763061|Secondary|Mean IOP Change From Baseline at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 9 AM|||mmHg||Standard Deviation|Mean
106410|NCT00763061|Primary|Mean Intraocular Pressure (IOP) at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At Week 12 - At the 9 AM time point for the patient's worse eye.|||millimeters mercury (mmHg)||Standard Deviation|Mean
106411|NCT00763048|Primary|Metabolite Associated With Inflammation (Xanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106412|NCT00763048|Primary|Metabolite Associated With Inflammation (Putrescine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106413|NCT00763048|Primary|Metabolite Associated With Inflammation (Phenylalanine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106414|NCT00763048|Primary|Metabolite Associated With Inflammation (Lysine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106415|NCT00763048|Primary|Metabolite Associated With Inflammation (Leucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106416|NCT00763048|Primary|Metabolite Associated With Inflammation (Isoleucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106417|NCT00763048|Primary|Metabolite Associated With Inflammation (Inosine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106418|NCT00763048|Primary|Metabolite Associated With Inflammation (Hypoxanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106419|NCT00763048|Primary|Metabolite Associated With Inflammation (Choline)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106420|NCT00763048|Primary|Metabolite Associated With Inflammation (Cadaverine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks|||ion count||Standard Deviation|Mean
106421|NCT00762996|Secondary|Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable|1 week|||Units on a scale||Standard Error|Least Squares Mean
106422|NCT00762996|Primary|Distance Visual Acuity|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|1 week|||logMar||Standard Error|Least Squares Mean
131675|NCT00538642|Secondary|Body Mass Index||Baseline|||Kg/m2||Standard Deviation|Mean
106423|NCT00762970|Primary|Axial Length (Axial Elongation)|Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||millimeter (mm)|Participants|Standard Deviation|Mean
106424|NCT00762970|Primary|Spherical Equivalent Refraction|Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.||diopter (D)|Participants|Standard Deviation|Mean
106425|NCT00762892|Secondary|Change From Baseline in Homocysteine at 6 Months||Baseline and 48 weeks|||umol/L||Standard Deviation|Mean
106426|NCT00762892|Secondary|Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks||Baseline and 48 weeks|||pg/mL||Standard Deviation|Mean
106427|NCT00762892|Primary|Change From Baseline in Log HIV Viral Load at 48 Weeks||Baseline and 48 weeks|||copies/mL||Standard Deviation|Mean
106428|NCT00762892|Secondary|Change From Baseline in Lipids at 48 Weeks||Baseline and 48 weeks|||mg/dL||Standard Deviation|Mean
106429|NCT00762892|Primary|Change From Baseline in CD4 Count at 48 Weeks||Baseline and 48 weeks|||cells/uL||Standard Deviation|Mean
106430|NCT00762853|Primary|Triclosan Concentration in Dental Plaque|Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.|12 hours|||ppm levels of triclosan||Standard Deviation|Mean
106431|NCT00762788|Primary|Incidence of Adverse Events|Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.||percentage of participants||95% Confidence Interval|Number
106432|NCT00762788|Primary|Incidence of Corneal Infiltrative Events|Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.||percentage of participants||95% Confidence Interval|Number
106433|NCT00762762|Primary|TNF-α (Tumor Necrosis Factor - Alpha)|Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.|12 months|||pg/ml||Standard Deviation|Mean
106434|NCT00762762|Primary|IL-6 (Interleukin - 6)|Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)|12 months|||pg/ml||Standard Deviation|Mean
106435|NCT00762762|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin|12 months|||ng/ml||Standard Deviation|Mean
106436|NCT00762762|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.|12 months|||µg/ml||Standard Deviation|Mean
106437|NCT00762762|Primary|HbA1c Levels in Blood|Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.|12 months|||percentage of HbA1c levels||Standard Deviation|Mean
106438|NCT00762723|Primary|Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)|- Fusion Assessment|Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months|Data not analyzed because study was stopped due to slow enrollment.|||||
106439|NCT00762645|Secondary|Number of Patients With Peripheral Anterior Synechiae (PAS)||Week 12 Visit|||Participants|||Number
106440|NCT00762645|Primary|Mean Intraocular Pressure (IOP)||4PM at Week 12 Visit|||millimeters mercury (mm Hg)||Standard Deviation|Mean
106441|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106442|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106443|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106444|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106445|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106446|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106447|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)-Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
109546|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 54||Baseline and week 54|Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
106448|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106449|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106450|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106451|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106452|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106453|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106454|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106455|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106456|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106457|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106458|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106459|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106460|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106461|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106462|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106463|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106464|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106465|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106466|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106467|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
109547|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 42||Baseline and week 42|Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
106468|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106469|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106470|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106471|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106472|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106473|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106474|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106475|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106476|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106477|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106478|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106479|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106480|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106481|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106482|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106483|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106484|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106485|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106486|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106487|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106488|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106489|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106490|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106491|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106492|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106493|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106494|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|3 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106495|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months|||Log cfu (colony forming units)||Standard Error|Least Squares Mean
106496|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).|3 months|||Log cfu (Colony Forming Units)||Standard Error|Least Squares Mean
106497|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|6 months|||Units on a scale||Standard Deviation|Mean
106498|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|3 months|||Units on a scale||Standard Deviation|Mean
106499|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.|6 months|||Units on a scale||Standard Deviation|Mean
106500|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.|3 months|||Units on a scale||Standard Deviation|Mean
106501|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months|||units on a scale||Standard Deviation|Mean
106502|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months|||units on a scale||Standard Deviation|Mean
106503|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months|||units on a scale||Standard Deviation|Mean
106520|NCT00762515|Primary|Control Established Plaque in Adults|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.|6 weeks|||Units on a scale||Standard Deviation|Mean
106504|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation–slight change in color and little change in texture,2 = Moderate inflammation–moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation–marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months|||units on a scale||Standard Deviation|Mean
106505|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months|||units on a scale||Standard Deviation|Mean
106506|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months|||units on a scale||Standard Deviation|Mean
106507|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months|||units on a scale||Standard Deviation|Mean
106508|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months|||units on a scale||Standard Deviation|Mean
106509|NCT00762606|Secondary|Corneal Astigmatism|Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.|3 months after surgery|||Diopters||Standard Deviation|Mean
106510|NCT00762606|Primary|Posterior Capsule Opacification Evaluation|The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.|12 months after surgery|||participants|||Number
106511|NCT00762528|Primary|8-iso-prostaglandinF2α (8-iso-PGF2α)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
106512|NCT00762528|Primary|Nuclear Factor Kappa B Ligand (RANK-L)|Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
106513|NCT00762528|Primary|Interleukin-6 (IL-6)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
106514|NCT00762528|Secondary|Bleeding on Probing (BOP)|Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.|29 days|||Units on a scale||Standard Deviation|Mean
106515|NCT00762528|Secondary|Dental Plaque Index (PI)|measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.|29 days|||Units on a scale||Standard Deviation|Mean
106516|NCT00762528|Primary|Interleukin - 1 Beta (IL-ß)|Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
106517|NCT00762528|Primary|Prostaglandin E2 (PGE2)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days|||pg/µl||Standard Deviation|Log Mean
106518|NCT00762528|Primary|Gingival Index (GI)|"Gingival Index(GI)recorded on scale of 0-3 detailed below:~0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed"|29 days|||units on a scale||Standard Deviation|Mean
106519|NCT00762515|Secondary|Control Gingivitis in Adults|Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).|6 weeks|||Units on a scale||Standard Deviation|Mean
106598|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106521|NCT00762502|Primary|Tarsal Roughness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
106522|NCT00762502|Primary|Bulbar Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
106523|NCT00762502|Primary|Limbal Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
106524|NCT00762502|Primary|Corneal Staining|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.||units on a scale|Participants|Standard Deviation|Mean
106525|NCT00762476|Secondary|Rhinovirus-associated Colds|The incidence of rhinovirus-associated cold illnesses.|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.||RV-associated cold illnesses per 100 sub|||Number
106526|NCT00762476|Secondary|Rhinovirus Infections.|The incidence of rhinovirus infections|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.||rhinovirus infections per 100 subjects|||Number
106527|NCT00762476|Primary|The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.|Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.||cold illnesses per 100 subjects|||Number
106528|NCT00762463|Secondary|Paracetamol Tablets Taken Per Day by Participant|Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.|Week 6|FAS||tablets per day||Standard Deviation|Mean
106529|NCT00762463|Secondary|Percentage of Days With Concomitant Administration of Paracetamol|Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.|Week 6|FAS||percentage of days||Standard Deviation|Mean
106530|NCT00762463|Secondary|Percentage of Participants With Concomitant Use of Paracetamol|Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6|Week 6|FAS||percentage of participants|||Number
106531|NCT00762463|Secondary|Change From Baseline in CRP at Week 12|CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mg/L||Standard Deviation|Mean
106532|NCT00762463|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 6|C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.|Baseline, 6 Weeks|FAS||mg/L||Standard Error|Least Squares Mean
106533|NCT00762463|Secondary|Change From Baseline in ESR at Week 12|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm/h||Standard Deviation|Mean
106534|NCT00762463|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6|Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.|Baseline, Week 6|FAS||mm/h||Standard Error|Least Squares Mean
106535|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Week 12|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||cm||Standard Deviation|Mean
106536|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Weeks 2, 4, and 6|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||cm||Standard Error|Least Squares Mean
106537|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Week 12|Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||cm||Standard Deviation|Mean
106732|NCT00761865|Secondary|Patient Satisfaction (Measured on a Visual Analog Scale)|Satisfaction on 0-10 scale with 10 being the best.|2 weeks post-sprain|||units on a scale||Full Range|Mean
137805|NCT00489086|Secondary|Estimated Duration of Complete Response||36 months||||||
106538|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6|Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||cm||Standard Error|Least Squares Mean
106539|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Week 12|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
106540|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
106541|NCT00762463|Secondary|Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20|Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).|Weeks 2, 4, 6, 12|FAS. N = total evaluable participants. n = evaluable participants at that time point.||percentage of participants|||Number
106542|NCT00762463|Secondary|Change From Baseline in BASDAI at Week 12|BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
106543|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6|Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
106544|NCT00762463|Secondary|Change From Baseline in BASFI at Week 12|BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
106545|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6|Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
106546|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.||units on a scale||Standard Deviation|Mean
106547|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6|5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||units on a scale||Standard Error|Least Squares Mean
106548|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.||units on a scale||Standard Deviation|Mean
106549|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.||units on a scale||Standard Error|Least Squares Mean
106550|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.||mm||Standard Deviation|Mean
106551|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement."|Baseline, Weeks 2, 4|Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.||mm||Standard Error|Least Squares Mean
106552|NCT00762463|Primary|Participant's Assessment of Global Pain Intensity at Baseline|"100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain."|Baseline|PP||mm||Standard Deviation|Mean
106553|NCT00762463|Primary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6|"100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement."|Baseline, Week 6|Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.||mm||Standard Error|Least Squares Mean
106554|NCT00762450|Primary|ph of Dental Plaque After Sucrose Challenge|Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.|1 week|||ph of dental plaque||Standard Deviation|Mean
106555|NCT00762424|Primary|Time of Stone Passage|Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.|10 Days|||hours||Inter-Quartile Range|Median
106556|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
106557|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
106558|NCT00762411|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
106559|NCT00762411|Secondary|Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
106560|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
106561|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
106562|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug|Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
106594|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
110748|NCT00727636|Primary|Antibody Titer to HPV 6||Month 7|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
106563|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug|Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
106564|NCT00762411|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
106565|NCT00762411|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug|Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
106566|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
106567|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug|Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
106568|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.||liters (L)||Geometric Coefficient of Variation|Geometric Mean
106569|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.||liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
106570|NCT00762411|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
106595|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106733|NCT00761865|Primary|Modified Karlsson Score|Ankle function score - range 0 to 100. Higher score is better ankle function.|2 weeks post-sprain|||units on a scale||Full Range|Mean
106571|NCT00762411|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer’s participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
106572|NCT00762411|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
106573|NCT00762411|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||ratio||Standard Error|Least Squares Mean
106574|NCT00762411|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
106575|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
106576|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks|Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant’s primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
106577|NCT00762411|Secondary|Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
106578|NCT00762411|Secondary|Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).||number of hospitalizations||Standard Error|Least Squares Mean
106579|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
106580|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
106596|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106581|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
106582|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
106583|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug|The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
106584|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks|The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Error|Least Squares Mean
106585|NCT00762385|Primary|Comfort Symptoms|A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable|1-week, 2-weeks|Only participants who completed the study per protocol (n=78)||score||Standard Error|Least Squares Mean
106586|NCT00762385|Secondary|Overall Corneal Staining|Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|2 weeks|Only the participants who completed the study per protocol (n=78)||combined score||Standard Error|Least Squares Mean
106587|NCT00762385|Primary|Lens Comfort|>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.|1-week, 2- weeks|Only participants who completed the study per protocol (n=78)||combined score||Standard Error|Least Squares Mean
106588|NCT00762359|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|18 Months|||participants|||Number
106589|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106590|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106591|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106592|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106593|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106597|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106599|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106600|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106601|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106602|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106603|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106604|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106605|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106606|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106607|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106608|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106609|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106610|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106611|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106612|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106613|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106614|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106615|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106616|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
109548|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 30||Baseline and week 30|Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
106617|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106618|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106619|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106620|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106621|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106622|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106623|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106624|NCT00762359|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Values are from the Full Analysis Set.||participants|||Number
106625|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106626|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106627|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106628|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106629|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106630|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106631|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106632|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106633|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Median
106634|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.||scores on a scale||Standard Deviation|Mean
106635|NCT00762359|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Participants not taking investigational drug were not included.||participants|||Number
106636|NCT00762320|Secondary|Parent Satisfaction|Parent Satisfaction Survey. Eight item Likert scale of parent/guardian satisfaction with the child's HIV treatment regimen. Item scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 4 week, 12 weeks and 24 weeks|||Score on a survey||Standard Deviation|Mean
106637|NCT00762320|Primary|Lopinavir and Ritonavir AUC on Low Dose Tablet|Lopinavir and Ritonavir AUC at 4 weeks when participants are receiving the study intervention, low dose tablet formulation of Kaletra. Data collection points for AUC were 0, 2, 4, 6, and 8 hours post dose.|4 weeks|All participants were analyzed||hr*ng/ml||Standard Deviation|Median
106638|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks|Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs|4 weeks|All participants were analyzed||ng/ml||Standard Deviation|Median
106639|NCT00762320|Primary|Viral Load (VL)|Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study|Baseline, Week 4, Week 12 and Week 24|All subjects in study were analyzed||participants|||Number
106640|NCT00762320|Secondary|Symptoms Across All Patients|Cumulative tally of symptoms for each patients across all visits. Targetted symptoms were asked for at each visit and patients and parents were encouraged to report additional symptoms that were experienced. Each patient got a score for the total number of symptoms at each visit. Scores were totalled, but it the same symptoms occurred continuously it was counted as 1 symptom.|Baseline, 1 month, 3 months, 6 months|All participants analyzed||numer of symptoms||Standard Deviation|Mean
106641|NCT00762320|Secondary|Patient Satisfaction|Patient Satisfaction Survey. Eight item Likert scale of patient satisfaction with their HIV treatment regimen for patients 7 years of age and older. Items scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 1 month|Patients had to be able to read and write to complete the patient satisfaction questionnaire, so an arbitrary age of 7 was selected and patients under the age of 7 did not complete the patient satisfaction questionnaire. All 5 of the patients over the age of 5 completed the questionnaire and were analyzed.||units on a scale||Standard Deviation|Mean
106642|NCT00762320|Primary|Lopinavir AUC Ratio of Baseline:Week 4|Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.|Baseline, week 4|||ratio||Standard Deviation|Mean
106643|NCT00762320|Primary|Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra|Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.|Baseline|All participants were analyzed||hr*ng/ml||Standard Deviation|Median
106644|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid|Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.|Baseline|All participants were analyzed||ng/ml||Standard Deviation|Median
106734|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms|Symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HARS). Minimum score = 0, Maximum score = 60. Higher scores on HARS indicate worse functioning|Baseline and 8 week treatment|Stable Bipolar Patients||units on a scale||Standard Deviation|Mean
106645|NCT00762320|Primary|Absolute CD4 and CD4 %|Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.|Baseline, 4 weeks, 12 weeks, 26 weeks|All participants were analyzed.||participants|||Number
106646|NCT00762268|Secondary|YMRS||6-weeks||||||
106647|NCT00762268|Secondary|HAM-D||6-weeks||||||
106648|NCT00762268|Primary|MADRS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.|At each weekly visit for 4 weeks|||units on a scale||Full Range|Mean
106649|NCT00762229|Secondary|Total Cholesterol|Total cholesterol fasting|4 weeks|||mg/dL||Standard Deviation|Mean
106650|NCT00762229|Primary|LDL Cholesterol|LDL cholesterol|4 weeks|||mg/dL||Standard Deviation|Mean
106651|NCT00762216|Secondary|Residual Refractive Cylinder|The refractive astigmatism 6 months post-surgery, measured in diopters.|6 Months post-surgery|69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.||diopters||Standard Error|Mean
106652|NCT00762216|Primary|Rotational Stability|Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.|6 Months post-surgery|67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.||degrees||Standard Error|Mean
106653|NCT00762177|Primary|Antimicrobial Species on the Cheek(Veillonella)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106654|NCT00762177|Primary|Antimicrobial Species in Tongue(Veillonella)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106655|NCT00762177|Primary|Antimicrobial Species in Saliva(Veillonella)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106656|NCT00762177|Primary|Antimicrobial Species in Plaque(Veillonella)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106657|NCT00762177|Primary|Antimicrobial Species on the Cheek(Sulfur Bacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106658|NCT00762177|Primary|Antimicrobial Species in Tongue(Sulfur Bacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106659|NCT00762177|Primary|Antimicrobial Species in Saliva(Sulfur Bacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106660|NCT00762177|Primary|Antimicrobial Species in Plaque(Sulfur Bacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106661|NCT00762177|Primary|Antimicrobial Species on the Cheek(Oral Streptococci)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106662|NCT00762177|Primary|Antimicrobial Species in Tongue(Oral Streptococci)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106735|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.|Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.|Baseline and 8 weeks treatment|Stable Bipolar Patients||units on a scale||Standard Deviation|Mean
106663|NCT00762177|Primary|Antimicrobial Species in Saliva(Oral Streptococci)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106664|NCT00762177|Primary|Antimicrobial Species in Plaque(Oral Streptococci)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106665|NCT00762177|Primary|Antimicrobial Species on the Cheek(Fusobacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106666|NCT00762177|Primary|Antimicrobial Species in Tongue(Fusobacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106667|NCT00762177|Primary|Antimicrobial Species in Saliva(Fusobacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106668|NCT00762177|Primary|Antimicrobial Species in Plaque(Fusobacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106669|NCT00762177|Primary|Antimicrobial Species on the Cheek(Total Anaerobic)|After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106670|NCT00762177|Primary|Antimicrobial Species in Tongue(Total Anaerobic)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106671|NCT00762177|Primary|Antimicrobial Species in Saliva(Total Anaerobic)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106672|NCT00762177|Primary|Antimicrobial Species in Plaque(Total Anaerobic)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106673|NCT00762177|Primary|Antimicrobial Species on the Cheek(Actinomyces)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106674|NCT00762177|Primary|Antimicrobial Species on the Tongue(Actinomycetes)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106675|NCT00762177|Primary|Antimicrobial Species in Saliva(Actinomyces)|Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106676|NCT00762177|Primary|Antimicrobial Species in Plaque(Actinomyces)|After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days|||log CFU (Colony forming units)||Standard Error|Log Mean
106677|NCT00762164|Secondary|Total Cholesterol||6 weeks|||% change in total cholesterol||Standard Deviation|Mean
106678|NCT00762164|Primary|LDL Cholesterol||6 weeks|||% change in LDL cholesterol||Standard Deviation|Mean
106679|NCT00762086|Primary|Absolute Claudication Distance (ACD)|Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters|3 months|ITT cohort||Meters||Standard Error|Least Squares Mean
106680|NCT00762073|Secondary|Mean Change in Blood Pressure (BP) at End of Treatment|BP was assessed for each treatment group at baseline and at each post-baseline visit including the final treatment evaluation.|Baseline, 12 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.||mmHg||Standard Deviation|Mean
106681|NCT00762073|Secondary|Percent of Participants With Potential Corticosteroid-Related Treatment-Emergent Adverse Events (TEAEs)|Corticosteroid-Related TEAEs included candidiasis, oesophageal candidiasis, crying, psychomotor hyperactivity, aggression, anger, anxiety, conduct disorder, emotional disorder, insomnia, or mood altered mood. Corticosteroid-Related TEAEs were assessed systematically during the treatment and taper periods.|15 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.||percentage of participants|||Number
106682|NCT00762073|Secondary|Area Under The Plasma Concentration-Time Curve (AUC) of Budesonide From Time Zero to Time of The Last Measurable Concentration (AUC0-last)|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.||hr*pg/mL||Standard Deviation|Mean
106683|NCT00762073|Secondary|Time to Maximum (Tmax) And Half Maximum (T1/2) Plasma Concentration of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together. T1/2 is the time to terminal elimination half-life.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.||hours||Standard Deviation|Mean
106684|NCT00762073|Secondary|Maximum Plasma Concentration (Cmax) of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The Pharmacokinetic (PK) Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.||pg/mL||Standard Deviation|Mean
106685|NCT00762073|Secondary|Change From Baseline in Physician's Global Assessment Score of Disease Severity|"Physician investigators were asked to complete a visual analog scale (VAS) to provide a global assessment of eosinophilic esophagitis (EoE) activity in each participant. The VAS was a 100-mm horizontal line on which the right extreme (100) was labeled “worst possible disease activity” and the left (0) was labeled “no disease activity.” Investigators were instructed to consider the line for the VAS as a continuum with their own opinion of extremes on either end. Investigators drew a vertical line at a point that best approximated the participant's current level of EoE disease activity. The investigator was to take into consideration how esophageal disease was impacting the participant’s daily activities. The following instruction was given to the investigators: Using the visual analog scale below, please mark a vertical line on the scale to indicate your assessment of EoE activity in this participant at this time. A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||scores on a scale||Standard Deviation|Mean
106686|NCT00762073|Secondary|Percent Change From Baseline in Eosinophilic Esophagitis (EoE) Clinical Symptom Score (CSS)|"The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1= Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2= Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3= Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors.~A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percent change||Standard Deviation|Mean
106687|NCT00762073|Secondary|Percent of Participants With Clinical Remission|"Clinical remission was defined as an eosinophilic esophagitis (EoE) clinical symptom score (CSS) of zero. EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
109549|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 18||Baseline and week 18|Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
106688|NCT00762073|Secondary|Percent of Participants With Clinical Response|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS). The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
106689|NCT00762073|Secondary|Change From Baseline in Endoscopy Score|Esophageal endoscopy was used to assess the level of inflammation and eosinophilia. Four categories of endoscopic findings were evaluated and scored for this study: (1) pallor and diminished vascular markings; (2) furrowing with thickened mucosa; (3) presence of white mucosal plaques; and (4) concentric rings or strictures. For each category, 0 points were allocated if no esophageal sites were involved, 1 point if 1 or 2 esophageal sites were involved, and 2 points for pan-esophageal involvement (see Aceves et al., 2007). The maximum possible endoscopy score was 8 points. A negative change from baseline indicates that esophageal inflammation decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||scores on a scale||Standard Deviation|Mean
106690|NCT00762073|Secondary|Percent Change From Baseline in Peak Eosinophil Count|The maximum peak number of eosinophils at baseline and at the final treatment evaluation was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value. A negative change from baseline indicates that eosinophil count has decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percent change||Standard Deviation|Mean
106691|NCT00762073|Secondary|Percent of Participants With Histologic Remission|Histologic remission was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤1 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
106692|NCT00762073|Secondary|Percent of Participants With Histologic Response|Histologic response was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤6 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
106693|NCT00762073|Primary|Percent of Participants Who Responded to Therapy|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS) and a reduction in peak eosinophil count to ≤6/high power field (light microscopy) from esophageal biopsies collected at the final evaluation. The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The Full Analysis Set (FAS), defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.||percentage of participants|||Number
106694|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression|Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score >0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with FR-α Cytoplasm or Membrane H scores. Participants censored: FR-α Positive Cytoplasm n=21, 15 and Negative n=4, 3; FR-α Membrane Positive n=16, 8 and Negative n=9, 10 for Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
106695|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression|Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score >0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TS Cytoplasm and Nucleus H scores. Participants censored: TS Cytoplasm Positive n=23, 20 and Negative n=4, 1; TS Nucleus Positive n=17, 9 and Negative n=10, 12 for the Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
110749|NCT00727597|Primary|Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events||96 weeks|||participants|||Number
106696|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment|Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score >0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TTF-1 H scores regardless of study treatment. Participants censored: n=38, 11 in the TTF-1 Nuclear Positive and Negative arms, respectively.||months||95% Confidence Interval|Median
106697|NCT00762034|Secondary|Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations|Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).|Baseline|All randomized participants with EGFR data regardless of study treatment.||participants|||Number
106698|NCT00762034|Secondary|Pharmacokinetics (PK): Bevacizumab Clearance (CL)||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.||liters per day (L/day)||Geometric Coefficient of Variation|Geometric Mean
106699|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.||microgram*day per milliliter (μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
106700|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.||days||Geometric Coefficient of Variation|Geometric Mean
106701|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
106702|NCT00762034|Secondary|Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
106703|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
106704|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
106705|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
106706|NCT00762034|Secondary|Pharmacokinetics (PK): Pemetrexed Clearance (CL)||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable CL data.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
106707|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable AUC(0-∞) data.||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
106708|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable t1/2 data.||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
106709|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable Cmax data.||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
106736|NCT00761761|Secondary|Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms|Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Minimum score = 0, Maximum score = 60. Higher scores on MADRS indicate worse functioning.|Baseline and 8 week treatment|Stable Bipolar patients||units on a scale||Standard Deviation|Mean
106738|NCT00761748|Primary|Preference of the Two Urostomy Products|"Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.~The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred."|6 weeks|The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). *One drop out was evaluable, as the subject tried both products and stated a preference.||participants|||Number
117317|NCT00670462|Secondary|Change From Baseline in Energy Intake at 6 Months||6 months|||kcal/day||Standard Error|Mean
106710|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)|FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items; each uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT/GOG-Ntx data, using the intent-to-treat principle.||units on a scale||Standard Error|Least Squares Mean
106711|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)|FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items. Each item uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-L, using the intent-to-treat principle.||units on a scale||Standard Error|Least Squares Mean
106712|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)|"The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction."|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-G data, using the intent-to-treat principle.||units on a scale||Standard Error|Least Squares Mean
106713|NCT00762034|Secondary|Number of Participants Receiving Concomitant Medication||Baseline to study endpoint (up to 37.06 months)|All randomized participants||participants|||Number
106714|NCT00762034|Secondary|Number of Participants Who Received a Transfusion||Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug.||participants|||Number
106715|NCT00762034|Secondary|Duration of Hospitalizations Per Participant|Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug and had at least one hospitalization while on study or within 30 days of discontinuation.||days||Standard Deviation|Mean
106716|NCT00762034|Secondary|Safety and Toxicity Profile of Study Treatments|Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug during the specified treatment phase.||participants|||Number
106717|NCT00762034|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=198, 172 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
106718|NCT00762034|Secondary|Progression Free Survival Time|Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=127, 109 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
106737|NCT00761761|Primary|Change From Baseline in Digit-Span Score at 8 Weeks|"Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented.~The raw scores for digit span ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome."|8 week treatment|||units on a scale||Standard Error|Least Squares Mean
106719|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)|Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle||percentage of participants||95% Confidence Interval|Number
106720|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)|Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle||percentage of participants||95% Confidence Interval|Number
106721|NCT00762034|Primary|Overall Survival|Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=131, 127 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.||months||95% Confidence Interval|Median
106722|NCT00762021|Primary|9% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.||LogMAR||Standard Deviation|Mean
106723|NCT00762021|Primary|100% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.||LogMAR||Standard Deviation|Mean
106724|NCT00762021|Primary|Posterior Capsule Opacification (PCO)|Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.|2 years after surgery|Data for all patients completing the 24 month visit were analyzed.||Percentage of PCO||Standard Deviation|Mean
106725|NCT00761969|Secondary|Incidence of Revascularization Procedures|Incidence of coronary, carotid and peripheral arterial revascularization procedures|5 years|||participants|||Number
106726|NCT00761969|Primary|Incidence of Major Cardiovascular Events|Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.|5 years:|||participants|||Number
106727|NCT00761956|Secondary|Return to Function (RtF) Via Knee Scoiety Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|24 Months|There was one case in the CR Flex Fixed cohort and 3 in the CR Standard Knee cohort where the Return to Function was not complete. Therefore, the total number analyzed is 51 instead of 52 and 45 instead of 48 respectfully.||units on a scale||Standard Deviation|Mean
106728|NCT00761956|Primary|Postoperative Range of Motion (ROM)|The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.|24 Months|There was one case in the CR Standard Knee cohort where the Range of Motion was not complete. Therefore, the total number analyzed is 47 and not 48.||degrees||Standard Deviation|Mean
106729|NCT00761930|Primary|Bleeding Index (EIBI)|Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.|6 weeks|||Units on a scale||Standard Deviation|Mean
106730|NCT00761930|Primary|Gingivitis Score|"Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored."|6 weeks|||Units on a scale||Standard Deviation|Mean
106731|NCT00761930|Primary|Dental Plaque|Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.|6 weeks|||Units on a scale||Standard Deviation|Mean
137806|NCT00489086|Secondary|Time to Progression||36 months||||||
106739|NCT00761735|Primary|Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender|The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.|Last assessment of the Part 2 LTFU (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU with non-missing Tanner Stage data at the last observation (up to Year 5 of the LTFU) were analyzed.||years||Standard Deviation|Mean
106740|NCT00761735|Primary|Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.||percentile||Standard Deviation|Mean
106741|NCT00761735|Primary|Mean Weight Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.||percentile||Standard Deviation|Mean
106742|NCT00761735|Primary|Mean Height Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.||percentile||Standard Deviation|Mean
106743|NCT00761735|Primary|Number of Participants Who Relapsed At End of LTFU Year 5|Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.|Part 2 LTFU Year 5|Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.||participants|||Number
106744|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2|Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
106745|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1|Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary.|From the day of dose 1 (Day 1) to Day 7 of dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
106746|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
106747|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 1 (Day 1) to Day 7 after dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants|||Number
106781|NCT00761462|Primary|Incidence of Nervous System Events (Cumulative)|Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug).||participants|||Number
109550|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 6||Baseline and week 6|Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing.||percent||Standard Deviation|Mean
106748|NCT00761631|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4|Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3 and 4|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.||titer||95% Confidence Interval|Geometric Mean
106749|NCT00761631|Primary|Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)|Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.|28 to 42 days after dose 1||||||
106750|NCT00761631|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3|Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.||mcg/mL||95% Confidence Interval|Geometric Mean
106751|NCT00761631|Primary|Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2|Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.|28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2|Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
106752|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
106753|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
106754|NCT00761605|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
106755|NCT00761605|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."||Millimeter (mm)||Standard Deviation|Mean
137807|NCT00489086|Secondary|Time to Lesion Clearance||36 months||||||
106756|NCT00761605|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."||Millimeter (mm)||Standard Deviation|Mean
106757|NCT00761605|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
106758|NCT00761605|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
106759|NCT00761605|Primary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
106760|NCT00761592|Secondary|Duration of Action|Median Duration for decision to reinject|Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)|Intention to Treat||Weeks||Standard Deviation|Median
106761|NCT00761592|Secondary|Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score|"Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect~+1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement."|Baseline to Week 4 and 8|Intention to Treat||Points on Scale||Standard Deviation|Mean
106762|NCT00761592|Secondary|Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)|Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open > 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.|Baseline to Week 4 and Week 8|Intention to Treat||Points on Scale||Standard Deviation|Mean
106763|NCT00761592|Secondary|Change From Baseline to Week 8 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 8|Intention to Treat||Points on Scale||Standard Deviation|Mean
106764|NCT00761592|Primary|Change From Baseline to Week 4 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 4|Intention to Treat||Points on Scale||Standard Deviation|Mean
106782|NCT00761462|Primary|Incidence of Arthropathy (Cumulative)|Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug)||participants|||Number
144091|NCT00435188|Primary|Rapid Gait Speed||3-month|||meters/second||Standard Deviation|Mean
106765|NCT00761579|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
106766|NCT00761579|Secondary|Change From Baseline in Sleep Quality at Week 48|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||millimeter (mm)||Standard Deviation|Mean
106767|NCT00761579|Secondary|Change From Baseline in Daytime Drowsiness at Week 48|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||millimeter (mm)||Standard Deviation|Mean
106768|NCT00761579|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||Units on a scale||Standard Deviation|Mean
106769|NCT00761579|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
106770|NCT00761579|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
106771|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
113830|NCT00703391|Primary|Haemoglobin (Hb)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||g/L||Standard Deviation|Mean
106772|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
106773|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
106774|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
106775|NCT00761527|Primary|Participant Global Tolerability Assessment|"The participant’s global assessment of tolerability with the medication was assessed using a categorical scale as follows:~Excellent~Very Good~Good~Fair~poor~Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented."|Day 15|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.||Participants|||Number
106776|NCT00761527|Secondary|Investigator Assessment of Clinical Efficacy|Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.|Day 15|ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported.||Participants|||Number
106777|NCT00761527|Primary|Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment|Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.||Participants|||Number
106778|NCT00761527|Primary|Number of Adverse Events Reported By Category After 14 Days of Treatment|Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.||Adverse Events|||Number
106779|NCT00761514|Primary|Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.|Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.|Week 24 of treatment|Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.||Percent change in average total score|||Number
106780|NCT00761514|Secondary|Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score|On visual analog scale (VAS), patient marks activity of rheumatoid arthritis in previous 24 hours (0 mm=no symptoms; 100 mm=very active). On another VAS, patient marks how much pain (0 mm=no pain; 100 mm=severe pain) he/she had because of the illness in previous week. Patient also marks tender joints and swollen joints on body diagrams. Number of swollen and painful joints and values on VAS are used with erythrocyte sedimentation rate to calculate the patient's global assessment of disease activity. High score indicates high activity.|Week 24 of treatment|Available subject data were used in calculations. Missing data were not imputed.||Percent change in average score|||Number
106783|NCT00761345|Secondary|To Measure Progression Free Survival and Overall Survival||Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survival||||||
106784|NCT00761345|Primary|To Determine the Dose Limiting Toxicities||weekly physician and nurse assessment and in between as needed until 30 days after treatment termination|27 patients (median age 64years and 15 male) with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible.||participants|||Number
106785|NCT00761319|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.|Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.||Percentage of patients|||Number
106786|NCT00761319|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.|Day 0, Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.||Units on a scale||Standard Error|Mean
106787|NCT00761306|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC||percentage of patients|||Number
106788|NCT00761306|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC||percentage of patients|||Number
106789|NCT00761306|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
106790|NCT00761306|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)||units on a scale||Standard Deviation|Mean
106791|NCT00761306|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS||percentage of patients|||Number
106792|NCT00761306|Primary|Number of Patients With Adverse Events (AEs)||Up to 52 weeks and a 4-week safety follow-up period|APTS||participants|||Number
106793|NCT00761280|Secondary|Median Time to Progression (Days) by Independent Review for the Intent-to-treat Population (Descriptive Analysis, Only)|Time to progression was calculated from the date of randomization to the date of the first documented tumor progression. Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death.|Up to 24 months|The Intent-to-treat population includes all participants randomized.||days||95% Confidence Interval|Median
106794|NCT00761280|Secondary|Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21 and 24 months|The Intent-to-treat population includes all participants randomized.||percentage of participants||95% Confidence Interval|Number
106795|NCT00761280|Secondary|Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21, and 24 months|The Intent-to-treat population includes all participants randomized.||participants|||Number
106805|NCT00761215|Secondary|Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set||21-28 days after last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.||Percentage of participants||95% Confidence Interval|Number
106806|NCT00761215|Secondary|Population PK||Multiple||||||
106807|NCT00761215|Secondary|To Evaluate the Safety Profile of Tedizolid Phosphate||Multiple||||||
144092|NCT00435188|Primary|Rapid Gait Speed||Baseline|||meters/second||Standard Deviation|Mean
106796|NCT00761280|Secondary|Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only)|"Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate.~Censoring rules were:~at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death.~at the date of last tumor assessment -- discontinuation other than PD or death, or if a new treatment was started prior to disease progression~at the date of death or last tumor assessment -- death or PD after one missed tumor assessment~at the date of last tumor assessment -- death or PD after more than one missed tumor assessment~at the date of last tumor assessment -- participants on ongoing treatment at data cut-off"|Up to 24 months|The Intent-to-treat population includes all participants randomized.||days||95% Confidence Interval|Median
106797|NCT00761280|Primary|Survival at 24 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to / insufficient follow-up includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point."|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||participants|||Number
106798|NCT00761280|Secondary|Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Participants with unknown or missing response were treated as non-responders.|Up to 24 months|The Intent-to-treat population includes all participants randomized.||percentage of participants||95% Confidence Interval|Number
106799|NCT00761280|Secondary|Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression.|Up to 24 months|The Intent-to-treat population includes all participants randomized.||percentage of participants||95% Confidence Interval|Number
106800|NCT00761280|Secondary|Response Category by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response."|Up to 24 months|The Intent-to-treat population includes all participants randomized.||participants|||Number
106801|NCT00761280|Secondary|Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only)|Median overall survival was defined as the date of randomization to the date of death. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis was by Kaplan-Meier estimation.|Up to 24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||days||95% Confidence Interval|Median
106802|NCT00761280|Secondary|Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to follow-up for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point."|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||participants|||Number
106803|NCT00761280|Secondary|Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||percentage of participants||95% Confidence Interval|Number
106804|NCT00761280|Primary|Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.||percentage of participants||95% Confidence Interval|Number
115902|NCT00684255|Secondary|Immune Reconstitution.|Peripheral blood for immune reconstitution for T-cell, B-cell and NK cells to be obtained for measurement of cell.|1 year||||||
106808|NCT00761215|Secondary|Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set|Persistent clinical cure was defined as continuing favorable response.|21 to 28 days after the last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.||Percentage of Participants|||Number
106809|NCT00761215|Secondary|Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set|Satisfactory microbiological outcomes are eradication and presumed eradication|7-14 days after last dose of study drug|The microbiologically evaluable analysis set includes all participants who received study drug, had a diagnosis of complicated skin and skin structure infection, completed an assessment, had no confounding events or factors, and had a baseline Gram-positive bacterial pathogen.||Percentage of participants||95% Confidence Interval|Number
106810|NCT00761215|Secondary|Response Rate at End of Therapy|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|last day of study treatment|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection||Percentage of participants||95% Confidence Interval|Number
106811|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7-14 days after last dose of study drug|The clinically modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection.||Percentage of participants||95% Confidence Interval|Number
106812|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7 to 14 days after the last dose of study drug|The Clinically Evaluable analysis set includes data from all participants who had a diagnosis of cSSSI, received minimal study therapy, completed an assessment, and had no confounding events or factors.||Percentage of participants||95% Confidence Interval|Number
106813|NCT00761202|Secondary|Lipid Layer Pattern Assessment|Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.|Week 1, month 1|Intent to Treat Population||Lipid Layer Mixing Pattern||Full Range|Median
106814|NCT00761202|Secondary|Daily Eyedrop Usage|Average daily eyedrop use|Month 1|Intent to Treat Population||drops/day||Standard Deviation|Mean
106815|NCT00761202|Secondary|Ocular Comfort and Ocular Symptoms on Visual Analogue Scale|Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)|week 1, month 1|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
106816|NCT00761202|Secondary|Conjunctival Hyperaemia|Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)|week 1, month 1|Intent to Treat Population||Percentage of Participants|||Number
106817|NCT00761202|Secondary|Corneal Staining by Fluorescein|Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population||Percentage of Participants|||Number
106818|NCT00761202|Primary|Conjunctival Staining by Lissamine Green|Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population||Percentage of Participants|||Number
106819|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."||Participants|||Number
106820|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Participants|||Number
106821|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Units on a scale||Standard Deviation|Mean
106822|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Units on a scale||Standard Deviation|Mean
115903|NCT00684255|Secondary|Chimerism|Percentage(%) of mixed and/or complete donor chimerism has been measured at different time points.|1 year||||||
106823|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
106824|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on a scale||Standard Deviation|Mean
106825|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Percentage of Participants|||Number
106826|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Percentage of participants|||Number
106827|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Units on a scale||Standard Deviation|Mean
106828|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Units on a scale||Standard Deviation|Mean
106829|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.||Percentage of participants|||Number
106830|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.||Percentage of participants|||Number
106831|NCT00761176|Primary|The Incidence of Wounds Reaching Complete Closure||approximate one year|Analysis was not done as this study was early terminated due to all subjects not meeting inclusion/exclusion criteria.|||||
106847|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
117318|NCT00670462|Secondary|Physical Activity, Energy Expenditure|change from baseline in energy expenditure at 6 months|6 months|||kcal/wk||Standard Error|Mean
106832|NCT00761150|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.||scores on a scale||Standard Error|Least Squares Mean
106833|NCT00761150|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).||scores on a scale||Standard Error|Least Squares Mean
106834|NCT00761137|Secondary|Percentage Change in Saliva Volume|Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined.|Before and 75 minutes after treatment administration|Percentage saliva volume change was determined in the last seven (7) patients enrolled.||percentage change of saliva volume||95% Confidence Interval|Median
106835|NCT00761137|Primary|Sialorrhea Visual Analogue Scale (VAS)|Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.|Before and 120 min after treatment administration|||cm on VAS||Standard Deviation|Mean
106836|NCT00760266|Secondary|Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8|Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg|At Weeks 4 and 8|Full analysis set||Percentage of Participants|||Number
106837|NCT00760266|Secondary|Percentage of Responders at Week 4 and Week 8|Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline|At 4 weeks and 8 weeks|Full analysis set||Percentage of Participants|||Number
106838|NCT00760266|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8||Baseline and Week 8|Full analysis set, restricted for msDBP to those with baseline msDBP at least 90 mm Hg)||mm Hg||Standard Error|Least Squares Mean
106839|NCT00760266|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set, restricted to baseline msDBP >= 90 mmHg||mm Hg||Standard Error|Least Squares Mean
106840|NCT00760266|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set||mm Hg||Standard Error|Least Squares Mean
106841|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106842|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106843|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106844|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106845|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106846|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
117319|NCT00670462|Primary|Change in Body Weight||18 months|||kg||Standard Deviation|Mean
106848|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106849|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106850|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
106851|NCT00760214|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
106852|NCT00760214|Primary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
106853|NCT00761007|Secondary|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234)||Participants|||Number
106854|NCT00761007|Post-Hoc|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat subgroup of patients with IBS-D and baseline pain score>1 (in a 5-point scale ranging from 0=no pain to 4=very severe) (N=189)||Participants|||Number
106855|NCT00761007|Secondary|Response of Overall IBS Symptom Relief - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-Treat (N=544)||Participants|||Number
106856|NCT00761007|Primary|Response of Overall IBS Symptom Relief - 50% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 2/4 weeks (50% rule)"|Four weeks|Intention-to-Treat (N=544)||Participants|||Number
106857|NCT00760877|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Months||95% Confidence Interval|Median
106858|NCT00760877|Secondary|Event-free Survival|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Months||95% Confidence Interval|Median
106859|NCT00760877|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.|48 months|24 months, Non-responders||months||95% Confidence Interval|Median
106860|NCT00760877|Secondary|Number of Cross-over Participants With CMR|The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 months, 48 months|Participants from the Imatinib treatment group who crossed over to the Nilotinib treatment group were analyzed.||Participants|||Number
106861|NCT00760877|Secondary|Rate of Confirmed Best Cumulative CMR|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 month, 48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Participants|||Number
144093|NCT00435188|Primary|Usual Gait Speed||12-month|||meters/second||Standard Deviation|Mean
106862|NCT00760877|Primary|Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|12 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.||Participants|||Number
106863|NCT00760838|Secondary|Change in Total Score on the Asthma-related Quality of Life (AQLQ)|"A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease~32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items)~7-point Likert scale (7 = not impaired at all - 1 = severely impaired).~Scores range 1-7, with higher scores indicating better quality of life."|from baseline to week 26|intention to treat analysis||units on a scale||Standard Deviation|Mean
106864|NCT00760838|Secondary|Change in Total Score on Asthma Control Questionnaire (ACQ)|"A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.~ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff~Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)~Scores range between 0 (totally controlled) and 6 (severely uncontrolled)."|from baseline to week 26|intention to treat analysis||units on a scale||Standard Deviation|Mean
106865|NCT00760838|Secondary|Change in Forced Expiratory Volume in 1 Second||from baseline to week 26|intention to treat analysis||percentage of baseline FEV1||Standard Deviation|Mean
106866|NCT00760838|Secondary|Peakflow Measurements|change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second|from baseline to week 26|intention to treat analysis||L/min||Standard Deviation|Mean
106867|NCT00760838|Secondary|Proportion of Participants Using Rescue Medication From Baseline to Week 26|"proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used.~This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26."|from baseline to week 26|intention to treat analysis||proportion of participants||Standard Deviation|Mean
106868|NCT00760838|Primary|Proportion of Participants With Severe Asthma Exacerbations|Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.|from baseline to week 26|intention to treat analysis||proportion of participants||95% Confidence Interval|Mean
106869|NCT00760747|Secondary|Number of Participants With Suicidal Behaviors and Ideations|Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.|Baseline through 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||participants|||Number
106870|NCT00760747|Secondary|Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.||kilogram||Standard Deviation|Mean
106871|NCT00760747|Primary|Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 2 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
106872|NCT00760747|Secondary|Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.||beats per minute||Standard Deviation|Mean
106873|NCT00760747|Secondary|Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.||mmHg||Standard Deviation|Mean
106874|NCT00760747|Secondary|Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint|The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
116962|NCT00673881|Secondary|Change in Plasma Cholesterol Ester Fractional Catabolic Rate (FCR)|Change in FCR from baseline to end-of-treatment (12 weeks)|Baseline to 12 weeks||||||
106875|NCT00760747|Secondary|Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint|CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score– Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||standard deviation units||Standard Error|Least Squares Mean
106876|NCT00760747|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint|The CGI- S is a single-item clinician rating of the severity of the participant’s ADHD symptoms in relation to the clinician’s total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
106877|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
106878|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
106879|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
106880|NCT00760747|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.||units on a scale||Standard Error|Least Squares Mean
106881|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction|An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
106882|NCT00760669|Primary|Number of Participants With Adverse Drug Reactions|Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as “not related”.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
106883|NCT00760669|Primary|Number of Participants With Unexpected Adverse Events|Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
106884|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.||Participants|||Number
106885|NCT00760669|Primary|Overall Efficacy Assessment|The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator’s discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.|Baseline up to Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.||Participants|||Number
106886|NCT00760669|Primary|Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30|The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline and Week 30|Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.|||||
106887|NCT00760669|Primary|Change From Baseline in Number of Tender Joints at Week 30|Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.||Tender joints||Standard Deviation|Mean
106888|NCT00760669|Primary|Change From Baseline in Number of Swollen Joints at Week 30|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.||Swollen joints||Standard Deviation|Mean
106889|NCT00760669|Primary|Change From Baseline in C-Reactive Protein (CRP) at Week 30|The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.||Milligram per deciliter||Standard Deviation|Mean
106890|NCT00760669|Primary|Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30|The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure.||Millimeter per hour||Standard Deviation|Mean
106891|NCT00760669|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30|The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure.||Millimeter||Standard Deviation|Mean
106892|NCT00760617|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
106893|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||subjects|||Number
106894|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||subjects|||Number
131676|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|Baseline|||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
106895|NCT00760617|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||fold increase||95% Confidence Interval|Geometric Mean
106896|NCT00760617|Secondary|HI Antibody Seroconversion Factor (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||fold increase||95% Confidence Interval|Geometric Mean
106897|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||subjects|||Number
106898|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||subjects|||Number
106899|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||subjects|||Number
106900|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||subjects|||Number
106901|NCT00760617|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||titers||95% Confidence Interval|Geometric Mean
106902|NCT00760617|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||titer||95% Confidence Interval|Geometric Mean
106903|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 180 to Day 209|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106904|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106905|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106906|NCT00760617|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106935|NCT00760487|Primary|Visual Acuity (VA)|Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|Pre-operative, 1 month, 3 month, and 6 month post-operative|||logMAR||Standard Deviation|Mean
133240|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks||240 weeks||||||
106907|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106908|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106909|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
106910|NCT00760617|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
106911|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
106912|NCT00760617|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
106913|NCT00760617|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
106914|NCT00760578|Post-Hoc|Change From Baseline in Insulin|Change from Baseline in insulin levels following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 pre-dose laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||uIU/mL||Standard Error|Least Squares Mean
106915|NCT00760578|Post-Hoc|Change From Baseline in FPG|Change from baseline in fasting plasma glucose (FPG) following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had Day 8 and Day 43 fasting plasma glucose values. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
106916|NCT00760578|Secondary|Change From Baseline in HDL|Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
106917|NCT00760578|Secondary|Change From Baseline in Triglycerides|Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
106918|NCT00760578|Secondary|Change From Baseline in FFAs|Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment|After 28 days of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
106919|NCT00760578|Secondary|Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test|Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.|After four weeks of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||uIU/mL||Standard Error|Least Squares Mean
106920|NCT00760578|Primary|Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test|Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.||mmol/L||Standard Error|Least Squares Mean
106921|NCT00760552|Primary|Blood Pressure Change|Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint—BP—will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).|Measured at Baseline, and 6,12,18,24, and 30 months post baseline.|||mmHg||Standard Deviation|Mean
106922|NCT00760526|Secondary|Parental Quality of Life Measures: CGM Satisfaction Scale|"Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)~JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679–684"|26 weeks|||units on a scale||Standard Deviation|Mean
106923|NCT00760526|Secondary|Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1–4. Higher score denotes fewer problems in the past month.|26 weeks|||units on a scale||Standard Deviation|Mean
106924|NCT00760526|Secondary|Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)|The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.|26 weeks|||units on a scale||Standard Deviation|Mean
106925|NCT00760526|Secondary|Parental Quality of Life Measures: Hypoglycemia Fear Survey|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0–100 with higher score denoting more fear. The results reported below are the values at 26 weeks.|26 weeks|||units on a scale||Standard Deviation|Mean
106926|NCT00760526|Secondary|Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)|Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data||percentage of median||Inter-Quartile Range|Median
106927|NCT00760526|Secondary|Measures of Variability: Mean Absolute Rate of Change|mean absolute rate of change|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data||mg/dL per minute||Inter-Quartile Range|Median
106928|NCT00760526|Secondary|Measures of Variability: Standard Deviation (SD)|standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.||mg/dL||Inter-Quartile Range|Median
106929|NCT00760526|Secondary|Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|26 weeks|||percentage of sensor readings||Inter-Quartile Range|Median
106930|NCT00760526|Secondary|CGM Glucose Values (mg/dL)|Percentage of sensors values in range (71 mg/dL to 180 mg/dL)|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data||percentage of sensor readings||Inter-Quartile Range|Median
106931|NCT00760526|Secondary|Number of Severe Hypoglycemic Events Experienced by Participants||26 weeks|Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.||events|||Number
106932|NCT00760526|Primary|Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events||26 weeks|Excludes five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models||participants|||Number
106933|NCT00760487|Secondary|IOL Rotation|Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.|6 months post-operative|||Percentage of Participants|||Number
106934|NCT00760487|Secondary|Spectacle Independence|Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit|6 months post-operative|||Percentage of participants|||Number
144094|NCT00435188|Primary|Usual Gait Speed||3 month|||meters/second||Standard Deviation|Mean
106936|NCT00760474|Secondary|Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria|Participant rated severity of pain upon application of 4 kilograms (kg) pressure via dolorimeter at the bilateral epicondyle tender points (2 tender points, 2 centimeters distal to the epicondyles) described in the American College of Rheumatology (ACR) classification criteria and scored on a 0 (no pain) to 10 (worst possible pain) rating scale. Each arm was to be assessed for any pain (one point on each arm) with the application of pressure.|Day 58|FAS; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
106937|NCT00760474|Secondary|Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked|"BP cuff evoked allodynia assessed based on participant response to the following question When I take your blood pressure, tell me if the cuff's pressure is painful. A standard BP cuff was inflated at approximately 10 millimeters of mercury (mm Hg) per second up to 180 mm Hg or to point when participant experienced pain; performed 3 times on each arm whether or not pain was reported. If no pain elicited at 180 mm Hg, it was recorded that no sphygmomanometry-evoked allodynia occurred. If pain was reported, value (in mm Hg) at which pain first occured was recorded for each of the assessments."|Day 58|FAS; N=number of participants with analyzable data at observation.||mm Hg||Standard Deviation|Mean
106938|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by the participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12). Total (overall) score was sum of items 1 to 15, range 0 to 45; higher scores indicated higher pain/impact. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.||scores on a scale||Standard Error|Least Squares Mean
106939|NCT00760474|Other Pre-specified|Pain Catastrophizing Scale (PCS) Including Outliers|"PCS is a participant rated 13-item instrument to measure the presence and severity of catastrophizing. Scored 0 (not at all) to 4 (all the time) to statements such as When I'm in pain…I worry all the time about whether the pain will end. All 13 statements start with When I'm in pain…. Total score ranged from 0 to 52; higher scores reflected greater impairment. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier."|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106940|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.||scores on a scale||Standard Error|Least Squares Mean
106941|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.||scores on a scale||Standard Error|Least Squares Mean
106942|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106943|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106944|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The individual daily pain score was defined as the final score recorded in the last pain diary of the treatment period 24 hours prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106982|NCT00759811|Secondary|Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels||12 weeks||||||
106945|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 3 day average pain score was defined as the mean daily pain NRS value for the last 3 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106946|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 7 day average pain score was defined as the mean daily pain NRS value for the last 7 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106947|NCT00760474|Secondary|Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers|Minimum and maximum pain unpleasantness acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (neutral) to 20 (very intolerable). Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106948|NCT00760474|Secondary|Gracely Box Scales for Pain Intensity (GBSint) Including Outliers|Minimum and maximum pain intensity acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (no pain sensation) to 20 (extremely intense). Baseline and Post-dose data for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS||scores on a scale||Standard Error|Least Squares Mean
106949|NCT00760474|Secondary|Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions|Resting state brain activity assessed for correlation of brain seed region (pIns, anIns) to ROI connectivity at baseline (pre-dose) and post-dose (pre minus post) measured using z-score (mean of 0, standard deviation [SD] of 1); range approximately -3 to +3. Positive (+) z-scores reflect greater connectivity (+correlation between seed region and ROI). Negative (-) z-scores reflect -connectivity (anti-correlation between seed region and ROI). ROIs include PCC and IPL from within the default mode network (DMN). DMN is a constellation of regions in which connectivity is augmented in fibromyalgia.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Participants in FAS with quality resting state data (data able to be corrected for motion [head and cardiorespiratory artifacts]).||z-score||Standard Deviation|Mean
106950|NCT00760474|Secondary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined ROI brain regions in response to checkerboard visual stimuli (flashing at 8 hertz [Hz]). Reported as percent change between the pre-dose (baseline) and post-dose values.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS.||percent change in BOLD signal||Standard Deviation|Mean
106951|NCT00760474|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC).||percent change||Standard Error|Least Squares Mean
106952|NCT00760474|Primary|Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)|Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Full Analysis Set (FAS) all participants who received a minimum fixed dose of 300 mg/day of study treatment. N=number of participants with analyzable data at observation.||ratio||Standard Deviation|Mean
106953|NCT00760435|Secondary|Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm|left anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area|2 weeks|||Z-score||95% Confidence Interval|Mean
106954|NCT00760435|Secondary|Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.||24 hours|||mg/dL||95% Confidence Interval|Mean
106955|NCT00760435|Secondary|Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)||up to 6 weeks|||days||Inter-Quartile Range|Median
106956|NCT00760435|Primary|The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion||10 weeks|1 subject in the placebo group was removed from the modified ITT analysis (this subject was removed from the study prior to receiving the placebo)||participants|||Number
106983|NCT00759811|Secondary|Improve in Quality of Life Measured Using the Brazilian Edition SF-36||12 weeks||||||
106957|NCT00760383|Secondary|Mid-thigh Muscle Volume|Analysis was performed using the Analyze 11 software package with semi-automated delineation of quadriceps, hamstrings, and adductors boarders. Using thresholding methods, the software can differentiate operator-delineated parameters set to distinguish muscle from non-muscle (i.e., adipose tissue) using voxel intensity within each border region for quantitative determination of muscle volume.|6 weeks|||Volume (cm^3)||Standard Error|Mean
106958|NCT00760383|Primary|Quadriceps Muscle Strength||6 weeks|||Newtons||Standard Error|Mean
106959|NCT00760383|Primary|Stair Time up||6 weeks|||seconds||Standard Error|Mean
106960|NCT00760084|Primary|The Number of Subjects With Adverse Events|Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (< 30% blasts) or AML (> 30% blasts).|3 months|||participants|||Number
106961|NCT00759954|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose|||ng*hr/mL||Standard Deviation|Mean
106962|NCT00759954|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng*hr/mL||Standard Deviation|Mean
106963|NCT00759954|Secondary|Time of Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|Subjects completed the study without protocol violations.||hour||Full Range|Median
106964|NCT00759954|Primary|Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng/mL||Standard Deviation|Mean
106965|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months|Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
106966|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
106967|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
106968|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).||mmHg||Standard Deviation|Mean
106969|NCT00759915|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
106970|NCT00759915|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
106971|NCT00759915|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||Hr||Full Range|Median
106972|NCT00759915|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||ng/mL||Standard Deviation|Mean
106973|NCT00759902|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
106974|NCT00759902|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr*ng/mL||Standard Deviation|Mean
106975|NCT00759902|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||hr||Full Range|Median
106976|NCT00759902|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs|||ng/mL||Standard Deviation|Mean
106977|NCT00759863|Secondary|Center for Epidemiologic Studies Depression Scale|The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The construct being assessed is the caregiver depression. Best value = 0. Worst Value = 60.|6 months|||Units on a scale||Standard Deviation|Mean
106978|NCT00759863|Secondary|Revised Memory and Behavior Problems Checklist|This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this “bothered or upset” them. A “conditional bother” score is calculated which is the “upset” or “bother” ratings for only the problematic behavior that occurred. Best value = 0. Worst Value = 96.|6 months|||Units on a scale||Standard Deviation|Mean
106979|NCT00759863|Primary|Multidimensional Observation Scale for Elderly Subject|"This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: Personal Care, Communication, Awareness & Memory, Mood, and Interpersonal Awareness Behaviors. The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144."|6 months|||Units on a scale||Standard Deviation|Mean
106980|NCT00759811|Secondary|Incidence of Adverse Effects of the Treatment||12 weeks||||||
106981|NCT00759811|Secondary|Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need||12 weeks||||||
106985|NCT00759811|Primary|Change in Physical Capacity Measured Using the 6-minute Walk Test Distance|The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).|Baseline and 12 weeks|||meters||Standard Deviation|Mean
106986|NCT00759759|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
106987|NCT00759759|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
106988|NCT00759759|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr||Full Range|Median
106989|NCT00759759|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng/mL||Standard Deviation|Mean
106990|NCT00759681|Primary|Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response|The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.|Treatment through 6 weeks|Based on ITT population for primary safety analysis.||participants|||Number
106991|NCT00759681|Primary|Immediate Sealing Evidenced by no Bleeding on Clamp Release.|The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery|Immediate at time of surgery|Treatment sites were the unit of measure based on ITT for effectiveness outcomes.||Treatment sites|Participants||Number
106992|NCT00759668|Primary|Near Uncorrected Visual Acuity Right Eye (UCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
106993|NCT00759668|Primary|Near Best Corrected Visual Acuity Right Eye (BCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
106994|NCT00759668|Primary|Near Uncorrected Visual Acuity Left Eye (UCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
106995|NCT00759668|Primary|Near Best Corrected Visual Acuity Left Eye (BCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
106996|NCT00759668|Primary|Near Uncorrected Visual Acuity (UCVA) Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
107081|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
106997|NCT00759668|Primary|Near Best Corrected Visual Acuity (BCVA) - Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.||Percentage of Participants|||Number
106998|NCT00759655|Secondary|Mean Number of Breakthrough (Spontaneous/Non-traumatic) Bleeds|The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours following a prophylaxis dose of Xyntha was summarized. The data from the electronic Infusion Log Diary plus the Test Article CRF was used to determine the number of infusions administered to treat a new bleed, counting only those infusions administered =<48 hours after an infusion marked as 'prophylaxis' (which had no associated bleed).|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Bleeds|Participants|Standard Deviation|Mean
106999|NCT00759655|Secondary|Response to First On-demand Xyntha Treatment for All New Bleeds as Assessed by the Caregiver|A 4-point response scale to be completed is as defined as follows: (Excellent: definite pain relief/improvement in signs of bleeding starting within 8 hrs after an infusion, with no additional infusion; Good: definite pain relief/improvement in signs of bleeding starting within 8 hrs or following the infusion; Moderate: probable/slight improvement starting after 8 hours following the infusion; No Response: no improvement at all between infusions).|Baseline to 24 months or early withdrawal|The study was terminated, analysis was not conducted.||Scores on scale|||Number
107000|NCT00759655|Secondary|Number of Xyntha Infusions Needed to Treat Each New Bleed|The data from the electronic Infusion Log Diary plus the Test Article case report form (CRF) was used to determine the number of infusions administered to treat a bleed. This was calculated by adding the initial ‘for a new bleed’ (on demand) infusion to any subsequent (on demand) infusions for the (same) ‘previously treated bleed’. An on-demand infusion for a ‘previously treated bleed’ was counted toward the bleed with the most recent start time prior to that infusion.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Infusions|Participants||Number
107001|NCT00759655|Secondary|Mean Annualized Bleed Rate (ABR)|An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Number of Bleeds|Participants|Standard Deviation|Mean
107002|NCT00759655|Primary|Percentage of Participants With Low Recovery LETE|The LETE could be considered lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Percentage of participants|||Number
107003|NCT00759655|Primary|Percentage of Participants With LETE in the Prophylaxis Setting|The LETE in the prophylaxis setting was the occurrence of a bleed. LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (=<48 hours) after a regularly scheduled prophylactic dose of Xyntha (which was not used to treat a bleed) in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Percentage of participants|||Number
107004|NCT00759655|Primary|Percentage of Participants With Less Than Expected Therapeutic Effects (LETE) in the On-Demand Setting|"LETE in the on-demand setting was based on the response to the treatment of a bleeding episode. LETE in the on-demand setting occurred if the participant recorded 2 successive No Response ratings (indicated there was no improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsened) after 2 successive Xyntha infusions, respectively. The infusions was to be administered within 24 hours (=<24 hours) of each other for the treatment of the same bleeding event in the absence of confounding factor."|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.||Percentage of Participants|||Number
107005|NCT00759655|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using Nijmegen modification of the Bethesda assay.|Baseline to 24 months or early withdrawal.|Intent-to-treat (ITT) population: Participants who had received at least 1 dose of Xyntha.||Percentage of participants|||Number
107006|NCT00759603|Primary|Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines|Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly & constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes>1500/µL, platelets>100,000/µL, hemoglobin>11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate & biopsy normocellular for age with <30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia & bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, &/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets>100,000/µL or 50% improvement; Hemoglobin>11.0 g/dL (untransfused) or 50% improvement.|Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.|||Percentage of Participants|||Number
107027|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following PF-03709270 Oral Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
121177|NCT00633867|Secondary|Difference in Learning to Use the Scopes|Is there a difference between trainee anaesthetists in learning to use the scopes|At analysis||||||
107007|NCT00759577|Primary|Improvement in Patient Perception of Bladder Condition Score (PPBC)|Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.|12 weeks|There was no questionnaire available for analysis. Secondary to poor enrollment the study was stopped and efforts to collect questionnaires at an earlier time point were not carried out.|||||
107008|NCT00759564|Secondary|Number of Participants With Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline, 7-10 days after the last dose of study drug|Safety analysis set included all participants who received the study medication.||participants|||Number
107009|NCT00759564|Secondary|Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for abnormal ECG (12-lead) values were defined as: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent for baseline value of >200 msec and >=50% for baseline value of <=200 msec for PR interval, QRS interval >=200 msec; QT interval corrected using the Fridericia formula (QTcF) >=500 msec or increase of >45 msec.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
107010|NCT00759564|Secondary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg, >=20 mmHg maximum increase and decrease from baseline in same posture, heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
107011|NCT00759564|Secondary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 6/High Power Field [HPF]).|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
107012|NCT00759564|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.||participants|||Number
107013|NCT00759564|Secondary|Concentration Versus Time Summary of Plasma Formate|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
107014|NCT00759564|Secondary|Concentration Versus Time Summary of 2-Ethylbutyric Acid|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
107015|NCT00759564|Secondary|Pharmacokinetics of CP-70429 and PF-03709270 Metabolites|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429 and metabolites.|0.5, 2, 4, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|Data was not collected for this outcome because the metabolite data for CP-70,429 and PF-03709270 were not analyzed as per change in planned analysis|||||
107016|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
121371|NCT00631540|Primary|Primary Patency of the Treated Renal Artery|Based on ultrasound images assessed by core lab.|9 Months|||Lesions|Participants||Number
107017|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 1.0 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 1.0 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
107018|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
107019|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 microgram per milliliter (mcg/mL) at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
107020|NCT00759564|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCinf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
107021|NCT00759564|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
107022|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following PF-03709270 Oral Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
107023|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following CP-70,429 Intravenous Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Standard Deviation|Mean
107024|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following PF-03709270 Oral Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||L/hr||Standard Deviation|Geometric Mean
107025|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70429 Following PF-03709270 Oral Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
107026|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following PF-03709270 Oral Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
107028|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following PF-03709270 Oral Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng/mL||Standard Deviation|Geometric Mean
107029|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following CP-70,429 Intravenous Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||liter per hour (L/hr)||Standard Deviation|Geometric Mean
107030|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70,429 Following CP-70,429 Intravenous Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||ng*hr/mL||Standard Deviation|Geometric Mean
107031|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following CP-70,429 Intravenous Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
107032|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following CP-70,429 Intravenous Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||hours||Full Range|Median
107033|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
107034|NCT00759525|Primary|Forearm Blood Flow|At the end of each 14-day intervention (Glycyrrhinitic acid or Placebo), vascular endothelial function was assessed by measuring forearm blood flow and comparing to Baseline. The outcome measure depicted below reflects the change in forearm blood flow from Baseline after completing the glycyrrhinitic acid regimen as well as the change in forearm blood flow from Baseline after taking the matching placebo.|Outcome was measured at the end of each study period (i.e. 14 days after Baseline measurements were taken)|||ml/100ml of tissue/min||Standard Error|Mean
107035|NCT00759473|Primary|Subjective Craving of Cocaine|Average of participants' subjective measures of craving immediately following cue exposure at the one-week follow-up session. Participants rated craving on a 10 point analog scale ranging from 0 (not at all) to 10 (extremely).|two weeks|Data of participants who completed all cue exposure sessions and the one-week follow-up were analyzed.||units on a scale||Standard Deviation|Mean
107036|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.|"Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score.~The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome."|Randomization to week 4|||Participants|||Number
107037|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.|"Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Randomization to week 4|||Participants|||Number
107038|NCT00759395|Secondary|Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).|"Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Week 4|||Units on a scale||Standard Error|Least Squares Mean
107039|NCT00759395|Primary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score.|The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.|Week 4|||Units on a scale||Standard Error|Least Squares Mean
119226|NCT00654784|Secondary|Respiratory Function: Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Maximal Inspiratory Pressure (MIP) and Peak Flow (PF)||1 year||||||
107040|NCT00759395|Primary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Week 4|||Units on a scale||Standard Error|Least Squares Mean
107041|NCT00759356|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
107042|NCT00759356|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr*ng/mL||Standard Deviation|Mean
107043|NCT00759356|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||hr||Full Range|Median
107044|NCT00759356|Primary|Mean Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|||ng/mL||Standard Deviation|Mean
107045|NCT00759330|Secondary|Patient Assessment of Wearability of Therapy|"At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where:~1 = Excellent, 4 = Poor."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||participants|||Number
107046|NCT00759330|Secondary|Percentage of Patients Who Discontinued|The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.|Days 1 through Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||percentage of patients who discontinued|||Number
107047|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The total amount (mg) of rescue medication used during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.||mg||Standard Error|Least Squares Mean
107048|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The percentage of patients who used rescue medication during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.||percentage of patients|||Number
107049|NCT00759330|Secondary|Patient Global Impression of Change (PGIC)|"At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where:~1 = very much improved, 7 = very much worse."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||participants|||Number
107050|NCT00759330|Secondary|Change From Baseline in Total Tender Point Examination Score|"At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where:~0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect."|Baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||units on a scale||Standard Error|Least Squares Mean
107051|NCT00759330|Secondary|Percent Change From Baseline in Total Functional Rating Index (FRI)|"Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome.~FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where:~Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100.~A positive percent change indicates a favorable treatment effect."|baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).||percent change from baseline||Standard Error|Least Squares Mean
107052|NCT00759330|Secondary|Average Daily Categorical Pain Scale Scores|"Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where:~0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time.~Data are reported as the daily average categorical pain scale score by treatment group."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||units on a scale||Standard Deviation|Mean
107053|NCT00759330|Secondary|Pain Intensity Difference (PID+)|"+PID = pre-treatment value at baseline – post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~A positive PID indicates a reduction in pain."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||units on a scale||Standard Error|Least Squares Mean
107082|NCT00758706|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ) Total|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Baseline and Week 6|Full analysis set||Score on scale||Full Range|Mean
107054|NCT00759330|Primary|Cumulative Summed Pain Intensity Difference (SPID+)|"The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient."|Days 4 and 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.||units on a scale||Standard Error|Least Squares Mean
107055|NCT00759187|Primary|Dental Plaque Index|Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)|4-Day|||Units on a scale||Standard Deviation|Mean
107056|NCT00759174|Other Pre-specified|Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows.|60-day period prior to onset of NAION symptoms|FAS population. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days or every week within 60 days prior to symptom onset.||exposed weeks|Participants||Number
107057|NCT00759174|Other Pre-specified|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|FAS included all participants who signed informed consent, were eligible for study and reported exposure to PDEi within 60 days prior to participant reported-onset of NAION symptoms. N (number of participants analyzed) represents Definite or Possible NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.||exposed days|Participants||Number
107058|NCT00759174|Primary|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|Full Analysis Set (FAS) included all participants who signed informed consent, were eligible for study, reported exposure to PDE5i within 60 days prior to participant-reported onset of NAION symptoms. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.||exposed days|Participants||Number
107059|NCT00759148|Secondary|Eradication of Baseline Bacteria (Microbiological Success)|Microbiological success|Day 4 (12-48 hours after Day 3 final dose)|Microbiological intent-to-treat population (patients that were bacterial positive at Day 1)||Participants|||Number
107060|NCT00759148|Primary|Clinical Cure of Bacterial Conjunctivitis|Absence of bulbar conjunctival injection and conjunctival discharge/exudate (clinical cure)|Day 4 (12-48 hours after Day 3 final dose)|Microbiological intent-to-treat population (patients that were bacterial positive at Day 1)||Participants|||Number
107061|NCT00759109|Other Pre-specified|Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI) at Baseline|Liver tissues obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome.|Baseline|ITT population||Score on a scale||Standard Deviation|Mean
107062|NCT00759109|Secondary|Change in the Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI)|"PCNA-LI was measured at baseline and at 18 months of treatment, and the change in PCNA-LI was calculated.~To measure PCNA-LI, liver tissue samples obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome."|Baseline and at 18 months of treatment|Participants with tissue biopsies at 18 months.||Score on a scale||Standard Deviation|Mean
107063|NCT00759109|Secondary|Number of Patients With a Virological Response Rate|"Virological Response rate was measured by the disappearance of Hepatitis C Virus from serum. Serum samples from participants were analyzed for the~presence of HCV-RNA using a qualitative polymerase chain reaction (PCR)."|Baseline and every year during 3 years of treatment|ITT population||Participants|||Number
107064|NCT00759109|Secondary|Survival Time of Participants|Survival time was defined as time from screening visit to the death of the participant and was studied with Kaplan-Meier and Log-rank tests. If a participant did not die, he or she was censored with the last available date.|During 3 years of treatment and 2 years of follow-up|ITT population||Years||95% Confidence Interval|Median
107065|NCT00759109|Secondary|Number of Participants With Development of Hepatic Decompensation|The development of hepatic decompensation, defined as worsening of the hepatic function as measured by Child Pugh Score. The Child Pugh score was calculated based on biochemical changes (changes in serum albumin, serum bilirubin, prothrombin time) and clinical impairment (ascites, encephalopathies) or both. Each of the 5 parameters was scored from 1-3, and the Child Pugh Score represented the total score. The maximum score was 15, and a score of 10-15 represents the worst outcome and a life expectancy of 1-3 years.|Baseline, During 3 years of treatment and 2 years of follow-up|ITT population||Participants|||Number
107066|NCT00759109|Primary|Number of Participants With the Development of Hepatocellular Carcinoma (HCC)|"Participants were tested for focal lesions by liver ultrasound and for AFP levels every 6 months the during study (treatment and follow-up).~The development of hepatocellular carcinoma was determined by:~the appearance of a focal lesion detected by liver ultrasound with metastases confirmed by fine needle biopsy, or~the appearance of a focal lesion detected by ultrasound + alphafetoprotein (AFP) levels in blood >400 ng/mL."|During 3 years of treatment and 2 years of follow-up|ITT population||Participants|||Number
107067|NCT00759096|Secondary|Contrast Sensitivity||6 months after sugery of the 2nd eye||||||
107068|NCT00759096|Primary|Near Uncorrected Visual Acuity(UCVA|Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.|6 months after surgery of 2nd eye|||logMAR||Standard Deviation|Mean
107069|NCT00759031|Primary|Gingival Margin Plaque Index|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.|1 day|||Units on a scale||Standard Deviation|Mean
107070|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 14 days post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).||participants|||Number
107071|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 48 hours post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).||Participants|||Number
107072|NCT00758836|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose.|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).|2 hours post-dose|The FAS comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.||Percentage of Participants|||Number
107073|NCT00758836|Primary|Percentage of Participants With Pain Freedom at Two Hours Post-dose|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).|2 hours post-dose|The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.||Percentage of Participants|||Number
107074|NCT00758771|Primary|Shear Rheology|Baseline measure of sputum shear rheology|Cross-sectional|||Pascal||Standard Error|Mean
107075|NCT00758758|Primary|Neck Disability Index (NDI)|"The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.~NDI scoring:~0 – 4 = No disability~5 – 14 = Mild disability~15 – 24 = Moderate disability~25 – 34 = Severe disability~35 or over = Complete disability"|12 Months|||units on a scale||Standard Deviation|Mean
107076|NCT00758758|Primary|Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)|Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months|12 Months|||participants|||Number
107077|NCT00758745|Primary|Posterior Capsule Opacification (PCO)|Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.|Up to 3 years|||Units on a scale||Standard Deviation|Mean
107078|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
107079|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
107080|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||Score on scale||Full Range|Mean
107083|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||L/min||Full Range|Mean
107084|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set||L/min||Full Range|Mean
107085|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Flow (FEF) 25−75% at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L/s||Full Range|Mean
107086|NCT00758706|Secondary|Change From Baseline in Inspiratory Capacity (IC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
107087|NCT00758706|Secondary|Change From Baseline in Vital Capacity (VC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
107088|NCT00758706|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
107089|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6||L||Full Range|Mean
107090|NCT00758706|Secondary|Incidence of Adverse Events|Number of patients who had an AE|all study visits|||Participants|||Number
107091|NCT00758706|Primary|Ratio of Total Urine Desmosine at Week 6 to Baseline|Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.||ratio||Full Range|Mean
107092|NCT00758706|Primary|Ratio of Sputum Total Cells at Week 6 to Baseline|Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.||ratio||Full Range|Mean
107093|NCT00758706|Primary|Ratio of TNF Alpha at Week 6 to Baseline|Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.||ratio||Full Range|Mean
107094|NCT00758680|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug||participants|||Number
107095|NCT00758680|Secondary|Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)|Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).|Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)|Per-Protocol Population; subset of participants who complied with the protocol sufficiently in terms of considerations as exposure to treatment, availability of measurements and absence of major protocol violations.||mg/dL||Standard Deviation|Least Squares Mean
107096|NCT00758680|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug||participants|||Number
107097|NCT00758667|Secondary|Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care||one year|||participants|||Number
107098|NCT00758667|Primary|Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care||one year|||participants|||Number
107099|NCT00758602|Secondary|Glomerular Filtration Rate (GFR) (mL/Min)|The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
107100|NCT00758602|Secondary|Serum Creatinine (Micromoles Per Liter [µmol/L])|The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.||µmol/L||Standard Deviation|Mean
107101|NCT00758602|Secondary|Participant and Graft Survival|The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.|Months 6 and 12|ITT population||percentage of participants|||Number
107164|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
107102|NCT00758602|Secondary|Percentage of Participants With Treatment Failure at 12 Months Post-Transplant|Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.|Month 12|ITT population||percentage of participants|||Number
107103|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant|The median time, in days, between randomization and acute rejection.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population||days||95% Confidence Interval|Median
107104|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant - Number of Participants With an Event||BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population||participants|||Number
107105|NCT00758602|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant||Months 6 and 12|ITT population||percentage of participants|||Number
107106|NCT00758602|Primary|Glomerular Filtration Rate (GFR) at Month 12 After Transplantation|GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].|Month 12|ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.||mL/min||Standard Deviation|Mean
107107|NCT00758602|Primary|Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation|CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.|Month 12|ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.||score on a scale||Standard Deviation|Mean
107108|NCT00758589|Secondary|Adverse Event (AE)|Number of patients reporting at least one event|4 weeks|||Participants|||Number
107109|NCT00758589|Secondary|Asthma Control Questionnaire 5 Items (ACQ5)|Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
107110|NCT00758589|Secondary|Forced Vital Capacity (FVC) at the Clinic|Mean FVC during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
107111|NCT00758589|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at the Clinic|Mean FEV1 during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
107112|NCT00758589|Secondary|Reliever Free Day|Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
107113|NCT00758589|Secondary|Symptom Free Day|Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
107114|NCT00758589|Secondary|Asthma Control Day|Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
107115|NCT00758589|Secondary|Awakenings|Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Percentage of days||Standard Deviation|Mean
107116|NCT00758589|Secondary|Day-time Asthma Symptom Score|Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Standard Deviation|Mean
107117|NCT00758589|Secondary|Night-time Asthma Symptom Score|Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Standard Deviation|Mean
107165|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Morning|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
107118|NCT00758589|Secondary|Total Use of Reliever|Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||Number of inhalations per day||Standard Deviation|Mean
107119|NCT00758589|Secondary|Evening Forced Expiratory Volume in 1 Second (eFEV1)|Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
107120|NCT00758589|Secondary|Morning Forced Expiratory Volume in 1 Second (mFEV1)|Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Standard Deviation|Mean
107121|NCT00758589|Secondary|Evening Peak Expiratory Flow (ePEF)|Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Standard Deviation|Mean
107122|NCT00758589|Primary|Morning Peak Expiratory Flow (mPEF)|Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Standard Deviation|Mean
107123|NCT00758576|Primary|Uncorrected Near Visual Acuity|Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.||Decimal Visual Acuity||Full Range|Mean
107124|NCT00758576|Primary|Uncorrected Distance Visual Acuity|Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.||Decimal Visual Acuity||Full Range|Mean
107125|NCT00758576|Primary|Uncorrected Intermediate Visual Acuity|Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.||Decimal Visual Acuity||Full Range|Mean
107126|NCT00758563|Primary|Mean Gingival Plaque Units|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).|1 day|||Units on a scale||Standard Deviation|Mean
107127|NCT00758550|Secondary|Questionnaire Results|Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).|6 Months|||Units on a scale||Standard Error|Mean
107128|NCT00758550|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 Months after surgery|||logMAR||Standard Deviation|Mean
107129|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Minutes||Standard Deviation|Mean
107130|NCT00758498|Secondary|Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Percent||Standard Deviation|Mean
107131|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Minutes||Standard Deviation|Mean
107132|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2||Minutes||Standard Deviation|Mean
107133|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here.|Day 3|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 3||Units on a scale||Standard Deviation|Mean
107134|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here.|Day 2|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 2||Units on a scale||Standard Deviation|Mean
107135|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here.|Day 1|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 1||Units on a scale||Standard Deviation|Mean
107136|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here.|Endpoint defined as either Day 3 or last observation after baseline|Safety analysis population defined as all subjects who had at least one dose of study drug and one State and Trait Anxiety Inventory Assessment after Baseline||Units on a scale||Standard Deviation|Mean
107137|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 3|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||units on a scale||Standard Error|Least Squares Mean
107138|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 2|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||units on a scale||Standard Error|Least Squares Mean
107139|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 1|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||units on a scale||Standard Error|Least Squares Mean
107140|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Baseline|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here."|Baseline, prior to start of study drug dosing|Full analysis set defined as all subjects who received at least one dose of study drug and had a baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
107141|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here.|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
107142|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here.|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
107143|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here.|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
107144|NCT00758498|Secondary|Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline|MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here.|Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1|||Minutes||Standard Deviation|Mean
107145|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here."|Day 3 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
107146|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here."|Day 2 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
107147|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here."|Day 1 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
107148|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here."|Baseline prior to starting study medication|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
107149|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
107150|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
107151|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
133241|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks||192 weeks||||||
107152|NCT00758498|Secondary|Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
107153|NCT00758498|Primary|Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2|"The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Units on a scale||Standard Error|Least Squares Mean
107154|NCT00758498|Primary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2|MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement||Minutes||Standard Error|Least Squares Mean
107155|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
107156|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
107157|NCT00758485|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)|The Intent-to-Treat (ITT) Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
107158|NCT00758459|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 6 weeks of treatment|||m||Full Range|Mean
107159|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings|Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Score on scale||Full Range|Mean
107160|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Scores on a Scale||Full Range|Mean
107161|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Scores on a Scale||Full Range|Mean
107162|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment|||Score on scale||Full Range|Mean
107163|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 4 and 6 weeks of treatment|||Score on scale||Full Range|Mean
107172|NCT00758420|Primary|The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks|The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4.|Baseline to 8 weeks|||units on a scale||Standard Error|Least Squares Mean
107173|NCT00758394|Primary|Dental Plaque Index|plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.|4-Day|||Units on a scale||Standard Deviation|Mean
107174|NCT00758342|Primary|Mean IOP (Intraocular Pressure)||Screening: Week 12; (At 9 am and 4 pm time points)|||mm Hg (millimeters mercury)||Standard Deviation|Mean
107175|NCT00758290|Primary|Dental Plaque Index|Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque|4 Day|||Units on a scale||Standard Deviation|Mean
107176|NCT00758160|Other Pre-specified|Global Assessment of Satisfaction by Participant|Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107177|NCT00758160|Secondary|Global Assessment of Satisfaction by Parents/Caregivers|Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107178|NCT00758160|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score|CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Participants|||Number
107179|NCT00758160|Secondary|Clinical Global Impression-Severity (CGI-S) Score|CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107180|NCT00758160|Secondary|Social Adjustment Scale Score for Children and Adolescents (SAICA)|SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children’s current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.|Baseline, Week 4 and Week 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107181|NCT00758160|Secondary|Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score|Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107182|NCT00758160|Secondary|Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score|Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.|Baseline, Week 4 and 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107677|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107183|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.|Baseline and Week 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107184|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.|Baseline and Week 4|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.||Units on a scale||Standard Deviation|Mean
107185|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.|Baseline and Week 8|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
107186|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.|Baseline and Week 4|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
107187|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.|Baseline and Week 2|Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
107188|NCT00758069|Secondary|Change From Baseline in Plasma Glucose|Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
107189|NCT00758069|Primary|Change From Baseline in 24-hour Weighted Mean Plasma Glucose|Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
107190|NCT00758043|Secondary|Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments||Week 72||||||
107191|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively).||Week 24 or Week 48|||participants|||Number
107192|NCT00758043|Secondary|Proportion of Enrolled Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up||Week 72||||||
107193|NCT00758043|Secondary|Proportion of Randomized Subjects Who Relapse, Defined as Those Who Complete Treatment, Have Undetectable HCV RNA at End of Treatment (EOT; Week 24 or Week 48 Respectively), and Become HCV RNA Detectable During Antiviral Follow-up||Week 24 or Week 28||||||
107194|NCT00758043|Secondary|Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment|SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.|12 weeks after last dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
107195|NCT00758043|Secondary|Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).|Week 4 and Week 12|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
107196|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at Week 72|SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.|72 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
107197|NCT00758043|Primary|Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)|SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).|24 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.||participants|||Number
107198|NCT00757848|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107199|NCT00757848|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107200|NCT00757848|Secondary|Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107201|NCT00757848|Secondary|Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107202|NCT00757848|Secondary|Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107203|NCT00757848|Secondary|Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107204|NCT00757848|Secondary|Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107205|NCT00757848|Secondary|Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107206|NCT00757848|Secondary|Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107207|NCT00757848|Primary|Cystic Fibrosis Questionnaire (CFQ-R) - Quittner|Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||units on a scale||Standard Error|Least Squares Mean
107208|NCT00757848|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||Signs and Symptoms|||Number
107209|NCT00757848|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
107210|NCT00757848|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L/min||Standard Error|Least Squares Mean
107211|NCT00757848|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
107212|NCT00757848|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
107213|NCT00757848|Primary|Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
107214|NCT00757848|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||L||Standard Error|Least Squares Mean
107215|NCT00757848|Primary|24-hour Sputum Weight|Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||grams||Standard Error|Least Squares Mean
107216|NCT00757848|Primary|Sputum Percentage Neutrophil Count|Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||percentage of neutrophils in WBCs||Standard Error|Least Squares Mean
107253|NCT00757627|Secondary|Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4|TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.|Baseline and Week 4|"22 patients who reported side effects at baseline and week 4 were included in side effect evaluation."||Units on a Scale||Standard Deviation|Mean
107217|NCT00757848|Primary|Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.||ratio||95% Confidence Interval|Least Squares Mean
107218|NCT00757822|Secondary|Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication|Percent of participants willing to pay extra money for preemptive medication for PONV for subsequent surgical procedures when queried at post-operative 24-48 hr. and at 2-6 wk. follow-up interviews.|Post-operative follow-up interviews 24 hr to 6 weeks post surgery|||percent of participants|||Number
107219|NCT00757822|Secondary|Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting|Percent of participants who responded that they would be willing to take preemptive medication for nausea and vomiting for subsequent surgeries when queried during post-operative follow-up interviews at 24-48 hrs or 2-6 weeks.|Post operative follow up interviews 24 hrs to 6 wks|||percent of participants|||Number
107220|NCT00757822|Secondary|Post-operative Antiemetic Use|Percentage of participants requiring post-operative anti-emetic medications.. Anti-emetic medication need was assessed during a) post-operative care unit (PACU) stay and b)during the first 48 hrs. following discharge from PACU to home or if applicable to in-patient unit.|End of surgery to 48 hr post surgery|||percentage of participants|||Number
107221|NCT00757822|Secondary|Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure|Number of all-cause hospital admissions on day of elective out-patient surgery .|Post-operative Day of Surgery (DOS)|||participants|||Number
107222|NCT00757822|Secondary|Post-Operative Care Unit Length of Stay (Min)|Length of time in PACU (minutes) measured from end of surgery to time of transfer to ambulatory care prior to home discharge or time to hospital admission if applicable.|Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)|||minutes||Inter-Quartile Range|Median
107223|NCT00757822|Primary|Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery|Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery.|24-48 hrs post surgery|||percentage of participants|||Number
107224|NCT00757822|Primary|Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale|"VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting.~VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU."|Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit|||percentage of participants|||Number
107225|NCT00757822|Primary|Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.|Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)|Per protocol||percentage of participants|||Number
107226|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||percentage of CD4 cells||Standard Deviation|Mean
107227|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||cells/uL||Standard Deviation|Mean
107228|NCT00757783|Secondary|Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.|Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||cells/micro L||Standard Deviation|Mean
107229|NCT00757783|Secondary|Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.|the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||Log10 HIV RNA||Standard Deviation|Mean
107230|NCT00757783|Secondary|Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)|Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.||number of participants|||Number
107231|NCT00757783|Secondary|Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.|Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.||number of participants|||Number
133283|NCT00528775|Primary|Tumor Response||6 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
107232|NCT00757783|Secondary|Change From Baseline in Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) at Week 12 and 48.|Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.||HOMA-IR score||Standard Deviation|Mean
107233|NCT00757783|Secondary|Change From Baseline in Insulin at Week 12 and 48.|Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.||IU/mL||Standard Deviation|Mean
107234|NCT00757783|Secondary|Change From Baseline in Glucose at Week 12 and 48.|Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.|Baseline, Week 12 and 48|Intent-to-treat (ITT) population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group.||mg/dL||Standard Deviation|Mean
107235|NCT00757783|Secondary|Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.|Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||ratio||Standard Deviation|Mean
107236|NCT00757783|Secondary|Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||g/L||Standard Deviation|Mean
107237|NCT00757783|Secondary|Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||grams per liters (g/L)||Standard Deviation|Mean
107238|NCT00757783|Secondary|Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mg/dL||Standard Deviation|Mean
107239|NCT00757783|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mg/dL||Standard Deviation|Mean
107240|NCT00757783|Secondary|Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||mg/dL||Standard Deviation|Mean
107241|NCT00757783|Primary|Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12|Observed values.|Baseline, Week 12|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.||milligram per deciliters (mg/dL)||Standard Deviation|Mean
107242|NCT00757705|Secondary|Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24|The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
107243|NCT00757705|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).|Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.||Participants|||Number
107308|NCT00756977|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||g/dL||Standard Deviation|Mean
142555|NCT00446992|Primary|Hemoglobin A1c||Baseline and 4 week intervals|||percentage||Standard Deviation|Mean
107244|NCT00757705|Secondary|Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24|The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.||Units on a scale||Standard Deviation|Mean
107245|NCT00757705|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants."|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
107246|NCT00757705|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.||Units on a scale||Standard Deviation|Mean
107247|NCT00757705|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
107248|NCT00757705|Secondary|Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Up to Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.||Percentage of participants|||Number
107249|NCT00757705|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
107250|NCT00757705|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using last observation carried forward (LOCF). Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.||Units on a scale||Standard Deviation|Mean
107251|NCT00757627|Secondary|Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4|Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 ~100, with 100 representing the best possible functioning)|Baseline and Week 4|Intention to treat (ITT)||Units on a Scale||Standard Deviation|Mean
107252|NCT00757627|Secondary|Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4||Baseline and Week 4|Only patients with both baseline and week 4 data were included in this analysis.||Days||Standard Deviation|Mean
142556|NCT00446992|Primary|Fasting Insulin||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
107254|NCT00757627|Secondary|Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4|BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).|Baseline and Week 4|Only patients with both baseline and week 4 follow up data were included in this analysis.||Units on a Scale||Standard Deviation|Mean
107255|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [ Not present, moderate and extreme]for discomfort and anxiety/depression|Week 4|per protocol||Percentage of participants|||Number
107256|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [Not present, moderate and extreme] for discomfort and anxiety/depression.|Baseline|"Only patients with baseline and week 4 data were included in the analysis.~Week 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422"||Percentage of Participants|||Number
107257|NCT00757627|Primary|"The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 Pain Walking on a Flat Surface at Week 4"|"WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent no pain and 100 represent extreme pain)"|Baseline and end of week 4|"Per protocol (all patients who completed the WOMACpain walking on a flat surface  question at baseline and follow up visit at week 4 will be included for analysis of this endpoint.~Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis."||Percentage of Participants|||Number
107258|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.|Week 4|Per Protocol||Percentage of Participants|||Number
107259|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.|Baseline|Only patients with baseline and week 4 data were included.||Percentage of Participants|||Number
107260|NCT00757627|Secondary|Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4|The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.|Baseline and Week 4|Only patients with baseline and week 4 data were included in this analysis of change||Units on a Scale||Standard Deviation|Mean
107261|NCT00757601|Secondary|Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006|The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||nM.hr||Standard Deviation|Mean
107262|NCT00757601|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.||participants|||Number
107263|NCT00757601|Secondary|Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||hr||Standard Deviation|Mean
107264|NCT00757601|Secondary|Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||hr||Full Range|Median
107265|NCT00757601|Secondary|Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||nM||Standard Deviation|Mean
107309|NCT00756977|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||mEq/L||Standard Deviation|Mean
107266|NCT00757601|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006|The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.||nM.hr||Standard Deviation|Mean
107267|NCT00757601|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.||participants|||Number
107268|NCT00757588|Other Pre-specified|Percentage of Participants With Reported and Confirmed Hypoglycemia|Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/|Baseline to Week 52|||Percentage of Participants|||Number
107269|NCT00757588|Other Pre-specified|Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period|"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4."|Baseline and during and up to 14 days after last dose of study drug (in Week 52)|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
107270|NCT00757588|Other Pre-specified|Shift in Platelet Counts From Baseline to Selected Visits (LOCF)|Platelet count=value*10^9 c/L|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
107271|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Heart Rate||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.||Beats per minute||95% Confidence Interval|Number
107272|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.||mm Hg||95% Confidence Interval|Number
107273|NCT00757588|Other Pre-specified|Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline to Week 52, continuously|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
107274|NCT00757588|Other Pre-specified|Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)|Absolute lymphocyte count=value*10^3 c/uL|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.||Participants|||Number
107275|NCT00757588|Other Pre-specified|Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results|"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions."|Baseline to Week 52|Participants who had normal ECG findings at baseline and who received at least 1 dose of study medication.||Participants|||Number
107276|NCT00757588|Secondary|Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)|Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.||Units||Standard Error|Mean
107277|NCT00757588|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response|Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.||Percentage of participants|||Number
107278|NCT00757588|Secondary|Change From Baseline in Fasting Plasma Glucose Values||Baseline to Week 24|||mg/dL||Standard Error|Mean
107279|NCT00757588|Secondary|Change From Baseline in 120-minute PPG Values During an MTT|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.|Baseline to Week 24|||mg/dL||Standard Error|Mean
107280|NCT00757588|Secondary|Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal|Baseline to Week 24|||mg*min/dL||Standard Error|Mean
120179|NCT00642304|Secondary|Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population||Days||Standard Deviation|Mean
107281|NCT00757588|Primary|Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])|Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24- and 52-week periods.||Percentage of change||Standard Error|Mean
107282|NCT00757484|Secondary|Surgical Time|Length of surgery|January 2007 to January 2008|||minutes||Full Range|Mean
107283|NCT00757484|Secondary|Percentage of Participants Undergoing Different Types of Anesthesia|Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).|January 2007 to January 2008|||percentage of participants|||Number
107284|NCT00757484|Secondary|Percentage of Women With Asymptomatic Hypotension|% women with asymptomatic hypotension|1 year|||percentage of participants|||Number
107285|NCT00757484|Primary|Percentage of Participants Who Underwent Gynecologic Surgery|491 women were included in analysis. Measure is categorized by the type of surgery.|January 2007 to January 2008|491 women were included in analysis.||percentage of participants|||Number
107286|NCT00757237|Other Pre-specified|Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)|"Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee.~Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||days||95% Confidence Interval|Median
107287|NCT00757237|Other Pre-specified|Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)|Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.|Day 0 through Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||events|||Number
107288|NCT00757237|Other Pre-specified|Total Number of Respiratory Hospitalizations|Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events.|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||hospitalizations|||Number
107289|NCT00757237|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20|This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication’s effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction.|At Week 20|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||units on a scale||Standard Error|Least Squares Mean
107290|NCT00757237|Other Pre-specified|Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20).|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The LOCF method was used to impute missing data for statistical purposes.||units on a scale||Standard Error|Least Squares Mean
107291|NCT00757237|Other Pre-specified|Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). LOCF method was used to impute missing data for statistical analyses.||Units on a scale||Standard Error|Least Squares Mean
107292|NCT00757237|Secondary|Time to First Respiratory Hospitalization|"This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events.~Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF.~Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||days||95% Confidence Interval|Median
107310|NCT00756977|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.||U/L||Standard Deviation|Mean
107311|NCT00756977|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population||standard %||Standard Deviation|Mean
107293|NCT00757237|Secondary|Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events|"IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee.~Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||days||95% Confidence Interval|Median
107294|NCT00757237|Secondary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months."|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on participants with prior inhaled tobramycin use >= 84 days in the previous 12 months using the ITT analysis set.||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
107295|NCT00757237|Secondary|Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on participants with previous inhaled tobramycin use of >= 84 days within the previous 12 months using the ITT analysis set. The last observation carried forward (LOCF) method was used to impute missing data for statistical analyses.||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
107296|NCT00757237|Primary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set."|Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
107297|NCT00757237|Primary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The last observation carried forward (LOCF) method was used to impute missing data.||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
107298|NCT00757172|Secondary|Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution|Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.|Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery|All recruited participants.||participants|||Number
107299|NCT00757172|Secondary|Percentage of Participants With 2-year Disease-free Survival|Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.|2 years|All registered participants who have met the eligibility criteria.||percentage of participants|||Number
107300|NCT00757172|Secondary|Percentage of Participants With 3-year Overall Survival|Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).|3 years|All registered participants who have met the eligibility criteria.||percentage of participants|||Number
107301|NCT00757172|Secondary|Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)||Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.||participants|||Number
107302|NCT00757172|Primary|Number of Participants With Pathologic Complete Response Following Surgery|Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.|Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.||participants|||Number
107303|NCT00756977|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days|||mOsm/kg||Standard Deviation|Mean
107304|NCT00756977|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days|||MILL/MCL||Standard Deviation|Mean
107305|NCT00756977|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days|||g/dL||Standard Deviation|Mean
107306|NCT00756977|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days|Intent to treat population||1000/MCL||Standard Deviation|Mean
107307|NCT00756977|Secondary|Serum Chemistry Results (GFR)|Change from Baseline|2 days|||ml/min||Standard Deviation|Mean
107314|NCT00756964|Primary|Number of Patients With Acute Kidney Injury (AKI).|Acute kidney injury will be defined as an increase in serum creatinine of 0.3mg/dL from baseline or a 50% increase in serum creatinine from baseline values within 48 hours after surgery.|Within 48 hours postoperatively|As no similar study has been performed, a power analysis could not be performed. As such, we decided to do a pilot study with 26 subjects and to set criteria to maximize the likelihood of seeing an effect.||Participants|||Number
107315|NCT00756938|Primary|Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.||Participants|||Number
107316|NCT00756938|Primary|Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.||Participants|||Number
107317|NCT00756938|Secondary|Mean Change From Baseline in Diastolic Blood Pressure|Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation||mmHg||Standard Deviation|Mean
107318|NCT00756938|Primary|Mean Change From Baseline in Systolic Blood Pressure|Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation||mmHg||Standard Deviation|Mean
107319|NCT00756886|Primary|Atrial Fibrillation||0-21 days post-operative|||participants|||Number
107320|NCT00756730|Primary|The Change in Fasting Triglyceride Level From Baseline to Week 24||Baseline to week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
107321|NCT00756730|Primary|At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||percentage of participants|||Number
107322|NCT00756730|Secondary|HDL Cholesterol at Week 24||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
107323|NCT00756730|Secondary|LDL Cholesterol at Week 24||week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
107324|NCT00756730|Secondary|Total Cholesterol in the Two Study Groups at 24 Weeks||Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||mg/dL||Full Range|Mean
107325|NCT00756730|Secondary|Difference in CD4 From Baseline to Week 24||baseline to Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.||cells/mm^3||Standard Error|Mean
107326|NCT00756730|Secondary|Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24||Week 4, 12 & 24|||percentage of participants|||Number
107327|NCT00756730|Primary|Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.|A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.|baseline, 24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.||percentage of patients|||Number
107328|NCT00756678|Secondary|Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16|Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.|Day 16|Intent to Treat; defined as all randomized (started study) patients.||Number of patients|||Number
107329|NCT00756678|Secondary|Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16|"Percentage of patients who responded Strongly Agree and Agree to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are Strongly Agree, Agree, Neither Agree or Disagree, Disagree and Strongly Disagree."|Day 16|Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure||Percentage of Patients|||Number
107330|NCT00756678|Secondary|Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16|Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.|Baseline, Day 16|Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure.||Scores on a scale||Standard Deviation|Mean
110265|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
107331|NCT00756678|Primary|Mean Frequency of Eye Drop Use Over 1 Week|Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.|1 week|Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure||Use per day||Standard Deviation|Mean
107332|NCT00756574|Secondary|Absenteeism|Absent from work because of flu-like illness|over study period|||participants|||Number
107333|NCT00756574|Secondary|Influenza-like Illness|Cough and fever|Over entire study period|||participants|||Number
107334|NCT00756574|Secondary|Physician Visits for Respiratory Illness|visit to primary care MD|one year|||participants|||Number
107335|NCT00756574|Primary|Laboratory-confirmed Influenza Infection|Laboratory confirmed influenza|one year|||participants|||Number
107336|NCT00756561|Primary|Intratesticular Hormones in Normal Men|Average between right and left testis for each subject and serum hormone concentration in 10 normal men|6-weeks|per protocol||ng/mL||Inter-Quartile Range|Median
107337|NCT00756548|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days|||mOsm/kg||Standard Deviation|Mean
107338|NCT00756548|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days|||million/microliter||Standard Deviation|Mean
107339|NCT00756548|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days|||1000/MCL||Standard Deviation|Mean
107340|NCT00756548|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days|||g/dL||Standard Deviation|Mean
107341|NCT00756548|Secondary|Serum Chemistry Results - Glomerular Filtration Rate|Change from Baseline|2 days|||ml/min||Standard Deviation|Mean
107342|NCT00756548|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days|||g/dL||Standard Deviation|Mean
107343|NCT00756548|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days|||mg/dL||Standard Deviation|Mean
107344|NCT00756548|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days|||U/L||Standard Deviation|Mean
107345|NCT00756548|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population||Percentage of cells||Standard Deviation|Mean
107346|NCT00756548|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days|||milliequivalent/L||Standard Deviation|Mean
107347|NCT00756548|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent)"|2 days|186 patients were included in the BLI850 intent-to-treat population. One patient took the preparation but did not undergo colonoscopy due to insurance coverage issues. This patient is excluded from all efficacy analyses.||percentage of participants||95% Confidence Interval|Number
107348|NCT00756470|Primary|Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy|Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.|Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)|With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.||Percentage of Participants|||Number
107349|NCT00756470|Secondary|Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)|Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.|Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)|While analyses was based on intent-to-treat (ITT) the surgical population includes only subjects who underwent definitive surgery (10 participants had a modified radical mastectomy) thus 5 were not evaluable for this outcome.||participants|||Number
107350|NCT00756457|Secondary|Foot Strength|A force transducer (Model SML-200, Interface, Scottsdale, AZ) was connected in series with a resistance plate and oscilloscope (TDS 410A, Tektronix, Beaverton, OR) to display force readings. Participants were seated with their leg in an an air stirrup brace (Aircast, Inc.) mounted on uprights. The air stirrup brace was adjusted so the heel was approximately 10 cm above the resistance plate, resulting in 30 to 45 degrees of ankle plantar flexion depending on foot length. The resistance plate was mounted on ball bearing tracks in the medial/lateral direction and moleskin was used to fit to the general shape of the medial forefoot. The result was that participants could exert maximum effort against the resistance plate (medial direction) with little discomfort. This testing position essentially replicates the manual muscle test position for the posterior tibialis muscle. Force in Newtons was then divided by body mass in kilograms to calculate normalized strength (N/Kg).|Measured at Weeks 1, 6, and 12|||N/kg||Standard Deviation|Mean
107351|NCT00756457|Primary|Short Musculoskeletal Functional Assessment|The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is a 46 item self-report questionnaire consisting of the Dysfunction Index, which has thirty-four items, and the Bother index which has 12 items. The Dysfunction index is used for assessment of patient perceptions of functional performance while the Bother index is used to assess patients’ perceptions of the degree patients are bothered in broad areas such as recreation and leisure. The responsiveness to change of the SMFA is 10 points out a range of 100 for each scale (Dysfunction, Mobility, and Bother indexes). The SMFA is also particularly suitable for the current investigation due to the presence of a sub-category of questions from the Dysfunction Index that pertains specifically to mobility (i.e. Mobility Index). Lower scores (lowest = 0) indicate better function, mobility, and that patients are less bothered while higher scores (highest = 100) indicate worse function, mobility and that patients are bothered.|Measured at Weeks 1, 6, and 12|||score||Standard Deviation|Mean
142557|NCT00446992|Primary|Fasting Glucose||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
107352|NCT00756457|Secondary|Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)|A 3 dimensional foot kinematic model including the tibia, calcaneus (hindfoot), 1st metatarsal, 2-4th metatarsals and hallux was used to measure foot movement. Six infrared cameras (Optotrak Motion Analysis System, Northern Digital Inc, CAN), synchronized with force plate data (Model 9286, Kistler, Switzerland), were used to collect kinematics (60 Hz) and force (1000 Hz) data with the Motion Monitor software Version 7.24 (Motion Monitor, Innsport Training Inc, USA). Anatomically based coordinate systems were established for each segment using digitized boney landmarks consistent with a previous study. Kinematic data were smoothed using a 4th order, zero phase lag, Butterworth filter with a cut off frequency of 6 Hz. To calculate relative joint angles a Cardan angle Z-X-Y sequence of rotations was used as suggested by Cole et al. The range of possible values varies for each individual and each joint.|Measured at Weeks 1,6 and 12|||Degrees||Standard Deviation|Mean
107353|NCT00756457|Primary|Foot Function Index(FFI)|The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.|Measured at Weeks 1, 6, and 12|A power analysis was performed based on previous a previous study. Only the participants that completed the study are included in the analysis. One participant opted to have surgery at 2 weeks from the Brace & Exercise group. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.||units on a scale||Standard Deviation|Mean
107354|NCT00756444|Primary|Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab|Steady-state plasma concentrations (Css) of 5-FU were estimated as the mean of two or more evaluable concentrations at 24, 72, and 96 hours after the start of 5-FU infusion. Css is estimated both for subjects receiving 5-FU with panitumumab and for subjects receiving 5-FU without panitumumab|24 to 96 hours following start of cycle 2 infusion with 5-FU|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive Css||ng/mL||Standard Deviation|Mean
107355|NCT00756444|Primary|Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab|AUC refers to area under the concentration curve from time 0 to last measurable concentration. AUC of total plasma cisplatin-derived platinum levels is estimated both for subjects receiving cisplatin with panitumumab and for subjects receiving cisplatin without panitumumab.|Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive AUC||ng*hr/mL||Standard Deviation|Mean
107356|NCT00756314|Secondary|Satisfaction With the Used Contraceptive Method|the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.|During the 6-month Follow-up|||participants|||Number
107357|NCT00756314|Primary|Chosen Contraceptive Method After Counseling|the type of contraceptive methods chosen by women following after counseling|after the contraceptive counseling|||participants|||Number
107358|NCT00756314|Secondary|Pregnancies Among All Women||within the first six months after intervention|||participants|||Number
107359|NCT00756314|Primary|Correct Use of the Method|the correct use was considerer by each methods according the prescription.|within the first 6 months after intervention|||participants|||Number
107360|NCT00756314|Primary|Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up|"The acceptability and the use of contraceptives during the follow-up period was defined as just yes or no"|after the contraceptive counseling and during the 6-month follow|"The analysis was by intention to treat in both groups. All the women were retained in their original assigned group."||participants|Participants||Number
107361|NCT00756093|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.|once upon instillation|||units on a scale||Standard Deviation|Mean
107362|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107363|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107364|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107425|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 85).|The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107365|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||Number of awakenings per night||Standard Error|Least Squares Mean
107366|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||Number of awakenings per night||Standard Error|Least Squares Mean
107367|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||Number of awakenings per night||Standard Error|Least Squares Mean
107368|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||awakenings after persistent sleep||Standard Error|Least Squares Mean
107369|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||awakenings after persistent sleep||Standard Error|Least Squares Mean
107370|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||awakenings after persistent sleep||Standard Error|Least Squares Mean
107371|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107372|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107373|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107374|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107375|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
142558|NCT00446992|Primary|Body Mass Index||Baseline and 4 week intervals|||kg/m^2||Standard Deviation|Mean
107376|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107377|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107378|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107379|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107380|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107381|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107382|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107383|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30).|Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107384|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107385|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||scores on a scale||Standard Error|Least Squares Mean
107386|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 29-30).|The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
107387|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 15-16).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
125433|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||2 days after first treatment|Safety||percentage of participants|||Number
107388|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 1-2).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
107389|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107390|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107391|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107392|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 29 -30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107393|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107394|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107395|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 29-30).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107396|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 15-16).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107397|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 1-2).|All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107398|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107399|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107400|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107401|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107402|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107403|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107404|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107405|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.||minutes||Standard Error|Least Squares Mean
107406|NCT00756002|Primary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.|Nights 1-2|The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data.||minutes||Standard Error|Least Squares Mean
107407|NCT00755937|Secondary|Number of Serious Adverse Events||Throughout study (up to 36 months)|Safety data were collected for all patients registered. Total number of subjects: 556. Non serious adverse events: 198. Serious Adverse Events: 105.||Number of Serious Adverse Events|||Number
107408|NCT00755937|Primary|Clinical Remission at 36 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
107409|NCT00755937|Primary|Clinical Remission at 24 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
107410|NCT00755937|Primary|Clinical Remission at 12 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
107411|NCT00755937|Primary|Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
107426|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 43).|The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107412|NCT00755937|Primary|Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
107413|NCT00755937|Primary|Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.||Participants|||Number
107414|NCT00755911|Secondary|Number of Participants Who Successfully Received Dental Implant Fixtures|The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures|12 months after tooth extraction|||participants|||Number
107415|NCT00755911|Primary|Bone Regeneration|"The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction.~Safety was assessed through adverse event reporting~Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)"|12 months after tooth extraction|||% bone height||Standard Deviation|Mean
107416|NCT00755846|Secondary|Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).|The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.|85 Days.|"Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline.~Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics."||percent incidence||Standard Deviation|Mean
107417|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 85).|The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107418|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 43).|The change between triglycerides collected at day 43 and triglycerides collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107419|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).|The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107420|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).|The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107421|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).|The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107422|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).|The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107423|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 85).|The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107424|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 43).|The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107482|NCT00755235|Secondary|Treatment Satisfaction|"Single item seven point scale ranging from very satisfied to very dissatisfied"|Measured after 6 months of treatment|||participants|||Number
146945|NCT00412841|Secondary|Number of Participants With AVN After 4 Months||4 months|||participants|||Number
107427|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 85).|The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107428|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 43).|The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
107429|NCT00755846|Secondary|Change From Baseline in Glycosylated Hemoglobin at Day 43.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
107430|NCT00755846|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
107431|NCT00755807|Secondary|Change From Baseline in Weight at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||kilograms (kg)||Standard Deviation|Mean
107432|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||beats per minute (bpm)||Standard Deviation|Mean
107433|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||mm Hg||Standard Deviation|Mean
107434|NCT00755807|Other Pre-specified|Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||gram/deciliter (g/dL)||Standard Deviation|Mean
107435|NCT00755807|Other Pre-specified|Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||milliEq/Liter||Standard Deviation|Mean
107436|NCT00755807|Other Pre-specified|Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||Thousand/microliter||Standard Deviation|Mean
107437|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase||Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.||participants|||Number
107438|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.||participants|||Number
107439|NCT00755807|Secondary|Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)||Baseline (6 weeks) through Endpoint (18 weeks)|All participants randomized to placebo in acute phase received duloxetine during the extension phase.||participants|||Number
107440|NCT00755807|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
107441|NCT00755807|Secondary|Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.|Baseline (6 weeks) through Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Error|Least Squares Mean
107442|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|18 weeks|All randomized participants who entered the extension phase.||participants|||Number
107483|NCT00755235|Primary|20-Item Symptom Checklist Depression Scale|20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.|Measured at baseline and after 6 months of treatment|Analysis included all participants participating in outcome assessment||units on a scale||Standard Deviation|Mean
107443|NCT00755807|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
107444|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
107445|NCT00755807|Secondary|Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline (end of acute phase/Week 6), Endpoint (Week 18)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
107446|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).|18 weeks|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.||units on a scale||Standard Deviation|Mean
107447|NCT00755807|Secondary|Change From Baseline in Weight at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||kilograms (kg)||Standard Error|Least Squares Mean
107448|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||beats per minute (bpm)||Standard Error|Least Squares Mean
107449|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||mm Hg||Standard Error|Least Squares Mean
107450|NCT00755807|Other Pre-specified|Change From Baseline in Uric Acid at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of uric acid.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||mg/dL||Standard Deviation|Mean
107451|NCT00755807|Other Pre-specified|Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||mg/dL||Standard Deviation|Mean
107452|NCT00755807|Other Pre-specified|Change From Baseline in the Platelet Count at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of platelet count.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||Thousand/microliter||Standard Deviation|Mean
107453|NCT00755807|Other Pre-specified|Change From Baseline in Creatinine at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of creatinine.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
107454|NCT00755807|Other Pre-specified|Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||milliEq/Liter||Standard Deviation|Mean
107455|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase||Baseline through 6 weeks|All randomized participants.||participants|||Number
107456|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline through 6 weeks|All randomized participants.||participants|||Number
107457|NCT00755807|Secondary|Number of Participants Who Discontinued During the Acute Phase (by Week 6)||Baseline through 6 weeks|All randomized participants.||participants|||Number
107458|NCT00755807|Secondary|Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Deviation|Mean
107459|NCT00755807|Secondary|Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
107484|NCT00755222|Primary|Change From Baseline in PDQ Penile Pain|Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
107460|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|6 weeks|All randomized participants.||participants|||Number
107461|NCT00755807|Secondary|Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
107462|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
107463|NCT00755807|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
107464|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|6 weeks|Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented.||units on a scale||Standard Error|Least Squares Mean
107465|NCT00755807|Secondary|Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation.||participants|||Number
107466|NCT00755807|Primary|Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.||units on a scale||Standard Error|Least Squares Mean
107467|NCT00755755|Primary|Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)|Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.|Week 13|Intent-to-treat||percentage of change||Full Range|Median
107468|NCT00755755|Primary|Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|Week 13 visit|Intent-to-treat||percentage of patients|||Number
107485|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Discomfort|"Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale."|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
107469|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 12 weeks|||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
107470|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 4 weeks|||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
107471|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|Form baseline to 12 weeks|||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
107472|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|From baseline to 4 weeks|||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
107473|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."||Percentage of participants|||Number
107474|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.|Day 28 post-single dose or Day 21 post-Dose 2|"Four-fold rises in vaccine Influenza titers were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."||Percentage of participants|||Number
107475|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."||Percentage of participants|||Number
107476|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 2|Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)||Participants|||Number
107477|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."||Percentage of participants|||Number
107478|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data."||Titers||95% Confidence Interval|Geometric Mean
107479|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."||Titers||95% Confidence Interval|Geometric Mean
107480|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.||Participants|||Number
107481|NCT00755261|Primary|RECIST|Study was terminated because of low accrual.|6 month PFS|study was terminated because of low accrual (4 subjects enrolled/2 years)|||||
107486|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Contraint|"Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale."|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
107487|NCT00755222|Primary|Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie’s Disease Symptom Bother|"Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale."|Baseline to Week 36 or LOCF|||scores on a scale||Standard Deviation|Mean
107488|NCT00755222|Primary|Change From Baseline in Penile Curvature|Negative change reflects improvement in penile curvature|Baseline and Week 36 or last observation carried forward (LOCF)|||Percent change from baseline||Standard Deviation|Mean
107489|NCT00755131|Other Pre-specified|Heart Rate Recovery at Baseline and 6 Months|"The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system.~Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease."|baseline and 6 month follow-up|||beats/min||Standard Deviation|Mean
107490|NCT00755131|Secondary|Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months|Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute.|Baseline and 6-month follow-up|intention to treat (ITT) analysis||ml/kg/min||Standard Deviation|Mean
107491|NCT00755131|Primary|High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months|High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response.|baseline and 6-month follow-up|||ng/ml||Standard Deviation|Mean
107492|NCT00755105|Primary|Rate of Iron Excretion.|Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55|4 years|Per protocol||milligrams per day||95% Confidence Interval|Mean
107493|NCT00755079|Secondary|Expiratory Respiratory Muscle Strength|Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.|||cmH2O||Standard Deviation|Mean
107494|NCT00755079|Primary|Inspiratory Respiratory Muscle Strength|Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.|||cmH2O||Standard Deviation|Mean
107495|NCT00755040|Secondary|Numerical Score of Ocular Surface Disease Index (OSDI) and Development or Lack of Ocular GVHD (by Ophthalmologic Examination) as Measured by Odds Ratio in a Linear Regression Model.|OSDI is a patient reported questionnaire consisting of 12 questions which are scored from 0 to 4. The total scored is computed and depending on the number of questions answered scores are computed which are then categorized into mild, moderate or severe dry eye symptoms. This tool should adequately reflect the morbidity of the dry eye symptoms.|1 year after transplant||||||
107496|NCT00755040|Primary|Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)|Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were <5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.|Up to 2 years after transplantation|Number of patients that develop ocular GVHD while on study||participants|||Number
107497|NCT00754923|Secondary|Mutational Status for EGFR or Kras||2008-present|||participants|||Number
107498|NCT00754923|Secondary|Toxicity||2008-present||||||
107499|NCT00754923|Secondary|Overall Survival||2008-present||||||
107500|NCT00754923|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate"|6 months|||participants|||Number
107501|NCT00754832|Secondary|Realtime Digital Fatigue Score|fatigue scored on 0-10 scale with higher scores indicating more fatigue|6 weeks of intervention|||units on a scale||Standard Deviation|Mean
107502|NCT00754832|Secondary|Modified Fatigue Impact Scale|21 item scale, score range 0-84, lower scores indicate less fatigue|6 weeks of intervention|||units on a scale||Standard Deviation|Mean
107503|NCT00754832|Primary|Fatigue Severity Scale|The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.|after 6 weeks of intervention|intention to treat||units on a scale||Standard Deviation|Mean
107504|NCT00754793|Primary|Sino-Nasal Outcome Test-20 (SNOT-20)||baseline, 1 month, 3 months||||||
107505|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 36 months post randomization|||participants|||Number
107525|NCT00754624|Secondary|Annual Rate of Change in DLCo From Baseline to End of Study||Baseline to 48 months|Safety||mL/min/mmHg per year||Standard Error|Mean
107526|NCT00754624|Secondary|Annual Rate of Change in FVC From Baseline to End of Study||Baseline to 48 months|Safety||Liters per year||Standard Error|Mean
136415|NCT00503113|Secondary|Relative Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population||mg/dL||Standard Deviation|Mean
107506|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization|||Adherence - proportion||Standard Deviation|Mean
107507|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization|||Adherence - proportion||Standard Deviation|Mean
107508|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization|||Adherence - proportion||Standard Deviation|Mean
107509|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization|||Adherence - proportion||Standard Deviation|Mean
107510|NCT00754741|Secondary|LDL Cholesterol Levels||at 12 months post randomization|||mg/dL||Standard Deviation|Mean
107511|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 12 months post randomization|||Percent||Standard Deviation|Mean
107512|NCT00754741|Secondary|LDL Cholesterol Levels||at 6 months post randomization|||mg/dL||Standard Deviation|Mean
107513|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 6 months post randomization|||Percent||Standard Deviation|Mean
107514|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 24 months post randomization|||participants|||Number
107515|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization|||Adherence - proportion||Standard Deviation|Mean
107516|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization|||Adherence - proportion||Standard Deviation|Mean
107517|NCT00754741|Primary|LDL-cholesterol Levels||at 18 months post randomization|||mg/dL||Standard Deviation|Mean
107518|NCT00754741|Primary|Glycated Hemoglobin Levels||at 18 months post randomization|||Percent||Standard Deviation|Mean
107519|NCT00754650|Secondary|Best Overall Response (BOR)|The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.||Percentage of participants|||Number
107520|NCT00754650|Primary|Bone Marrow Response|Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.||Percentage of infiltration||Inter-Quartile Range|Median
107521|NCT00754624|Secondary|High Resolution Computerized Tomography Scans of the Chest||End of study|participants in Safety population with available post-baseline data||participants|||Number
107522|NCT00754624|Secondary|Change in Weight in kg From Baseline to End of Study|Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months)|Safety||kilograms||Standard Deviation|Mean
107523|NCT00754624|Secondary|Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)|Change from Baseline to last study measurement on treatment (maximum of 48 months)|Baseline to last study measurement on treatment (maximum of 48 months)|||milligrams per deciliter||Standard Deviation|Mean
107524|NCT00754624|Secondary|Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)|Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months|Safety||percentage||Standard Deviation|Mean
146946|NCT00412841|Primary|Number of Participants With AVN After 9 Months||9 months|||participants|||Number
107529|NCT00754572|Secondary|Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||score on a scale||Standard Deviation|Mean
107530|NCT00754572|Secondary|Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity and DAS28<2.6 = remission|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
107531|NCT00754572|Secondary|Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population. All participants with endpoint values collected at Week 24 were included in the analysis.||score on a scale||Standard Deviation|Mean
107532|NCT00754572|Secondary|AUC of DAS28|The AUC was computed using the trapezoidal rule, considering baseline value as 0, through NCSS software. For each participant, AUC for DAS28 units was calculated. Each individual AUC DAS28 value was divided by 52 to have the conversion of AUC DAS28 in unit weeks to AUC DAS28 in unit years, as 1 week is approximately 1/52 years. The set of individual AUC DAS28 was computed as summary statistics.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.||scores on a scale * years||Standard Deviation|Mean
107533|NCT00754572|Secondary|Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24|DAS28- based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with DAS28 < 3.2; moderate response: change from baseline >1.2 with DAS28 >3.2 to <5.1 or change from baseline >0.6 to <1.2 with DAS28 <5.1; No response: change from baseline < 0.6 or change from baseline >0.6 and <1.2 with DAS28 >5.1.|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
107534|NCT00754572|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24|DAS28 calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||score on a scale||Standard Deviation|Mean
107535|NCT00754572|Secondary|Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models|The probability of ACR positive response was determined using the GEE.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Population; All participants with endpoint values collected were included in the analysis.||odds||95% Confidence Interval|Number
107536|NCT00754572|Secondary|Percentage of Participants Achieving ACR20 Response|"ACR20 is defined as 20% improvement in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the HAQ-DI~Acute phase reactant levels - ESR or CRP"|Week 2|ITT Population; All participants with endpoint values collected at Week 2 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
107537|NCT00754572|Secondary|Area Under The Curve (AUC) of the ACR(n)|ACR-n was defined as the lowest of 3 values (the percent change in the swollen joint count, the percent change in the tender joint count, and the median of the other 5 measures in the ACR core data set which included Participant's global assessment of pain (VAS), Participant's global assessment of disease activity (VAS), Investigator/Physician's global assessment of disease activity (VAS), Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP). Therefore, a percentage value was assigned to each participant at each timepoint. AUC was calculated for each participant from baseline to Week 112. Mean and standard deviation values are are provided in percent*years.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.||percent*years||Standard Deviation|Mean
107538|NCT00754572|Secondary|Percent Change From Baseline in HAQ-DI at Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
107675|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
136416|NCT00503113|Secondary|Absolute Change From Baseline in Mean Serum Creatinine.||Baseline and 9 months|PP Population||mg/dL||Standard Deviation|Mean
107539|NCT00754572|Secondary|HAQ-DI at Baseline and Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 =without difficulties; 1= with some difficulties; 2=with great difficulties; and 3= unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified time point.||units on a scale||Standard Deviation|Mean
107540|NCT00754572|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
107541|NCT00754572|Secondary|Physician's Global Assessment of Disease Activity at Baseline and Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified visit.||mm||Standard Deviation|Mean
107542|NCT00754572|Secondary|Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
107543|NCT00754572|Secondary|Participant's Global Assessment of Disease Activity at Baseline and Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n= number of participants analyzed for the given parameter at the specified time point.||mm||Standard Deviation|Mean
107544|NCT00754572|Secondary|Percent Change From Baseline in Pain as Assessed by the Participant at Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at Baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
107545|NCT00754572|Secondary|Pain as Assessed by the Participant at Baseline and Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at the specified timepoints were included in the analysis. number (n) equals (=) number of participants analyzed for the given parameter at the specified time point.||mm||Standard Deviation|Mean
107546|NCT00754572|Secondary|Percent Change From Baseline in SJC and TJC at Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||percent change||Standard Deviation|Mean
107547|NCT00754572|Secondary|SJC and TJC at Baseline and Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.||joints||Standard Deviation|Mean
107548|NCT00754572|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.|||||
107676|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107549|NCT00754572|Secondary|Time to Onset of ACR20, ACR50, and ACR70|"ACR20, ACR50 and ACR70 are defined as 20, 50 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.|||||
107550|NCT00754572|Secondary|Percentage of Participants With ACR20 and ACR70 Response at Week 24|"ACR20 and ACR70 are defined as 20 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
107551|NCT00754572|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments:~Participant's global assessment of pain by Visual Analog Scale (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)~Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.||percentage of participants||95% Confidence Interval|Number
107552|NCT00754559|Secondary|Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response|Participants who withdrew from study drug due to other reasons were not taken into account.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; participants who withdrew from study drug due to other reaasons were not included in the analysis.||percentage of participants||95% Confidence Interval|Number
107553|NCT00754559|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammation marker used to determine acute phase response.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.||mm/h||Standard Deviation|Mean
107554|NCT00754559|Secondary|Changes in C-Reactive Protein|CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.|Baseline, Weeks 1, 2 ,4 and 24|ITT Population||mg/L||Standard Deviation|Mean
107555|NCT00754559|Secondary|Changes in Hemoglobin|Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.||g/dL||Standard Deviation|Mean
107556|NCT00754559|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Score|The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: “effectiveness”, “side-effects”, “convenience” and “global satisfaction”. All subscale scores range from 0 to 100%, with 100% being the best possible result.|Week 24|ITT Population||units on a scale||Standard Deviation|Mean
107557|NCT00754559|Secondary|Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF|Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2 and 4|ITT Population; Missing data were imputed using LOCF.||mm||Standard Deviation|Mean
107558|NCT00754559|Secondary|Duration of Morning Stiffness as Assessed Using PTHF|Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline, Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.||hours||Standard Deviation|Mean
107559|NCT00754559|Secondary|Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)|Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.||mm||Standard Deviation|Mean
107560|NCT00754559|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.|Week 24|ITT Population; Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
107561|NCT00754559|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population; Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
107562|NCT00754559|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 24|ITT Population; Missing data were imputed using LOCF.||units on a scale||Standard Deviation|Mean
107563|NCT00754559|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|"CDAI was calculated according to the following formula:~CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity."|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population; only participants with values for CDAI at baseline and the respective visit were included in the analysis.||units on a scale||Standard Deviation|Mean
107564|NCT00754559|Secondary|Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24|"Participant’s global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”).~Physician’s global assessment of disease activity was measured as participant’s current disease activity on a 100-mm horizontal VAS scale (left hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”)."|Week 24|ITT Population; missing data were imputed using LOCF.||mm||95% Confidence Interval|Mean
107565|NCT00754559|Secondary|Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24|Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Week 24|ITT Population; missing data were imputed using LOCF.||mm||95% Confidence Interval|Mean
107566|NCT00754559|Secondary|Change From Baseline in the Levels of C-Reactive Protein at Week 24|The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.|Week 24|ITT Population; missing data were imputed using LOCF.||mg/L||95% Confidence Interval|Mean
107567|NCT00754559|Secondary|Change From Baseline in Swollen and Tender Joint Counts at Week 24|"Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.~Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68."|Week 24|ITT Population; missing data were imputed using last observation carried forward (LOCF).||Joints||95% Confidence Interval|Mean
107568|NCT00754559|Secondary|Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response|ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
107569|NCT00754559|Secondary|Percentage of Participants With a DAS28 Response at Weeks 4 and 24|DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 <2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.|Weeks 4 and 24|ITT Population;||percentage of participants||95% Confidence Interval|Number
107570|NCT00754559|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population||Percentage of Participants|||Number
107571|NCT00754559|Secondary|Absolute Changes in DAS28 From Baseline|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant rated global assessment of disease activity using 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; only participants with a DAS28 value at baseline were included in the analysis.||units on a scale||Standard Deviation|Mean
107572|NCT00754559|Primary|Percentage of Participants With Low Disease Activity Score at Week 24|Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Week 24|ITT population.||Percentage of Participants||95% Confidence Interval|Number
107573|NCT00754546|Secondary|Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise|"linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise~The higher the number the worse the shortness of breath"|After one dose|||breathlessness units/min||Standard Deviation|Least Squares Mean
107574|NCT00754546|Primary|Exercise Endurance Time|Participants were asked to exercise until symptom limitation|After one dose|Number of participants determined by previous studies. Analysis was intention to treat||seconds||Standard Deviation|Mean
107575|NCT00752791|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 1-19) and Evaluation Period (Weeks 20-25). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 25|Safety Analysis Set. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.||percentage of participants|||Number
139639|NCT00470301|Primary|Recommended Phase II Dose of Tipifarnib When Combined With Weekly Sequential Paclitaxel (Phase I)||2 weeks||||||
107576|NCT00752791|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 25 weeks.|Full analysis set where data was available for each time interval (indicated by N).||percentage of participants||95% Confidence Interval|Number
107577|NCT00752791|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). One patient did not have central lab hemoglobin value during a regularly scheduled visit during weeks 2-5.|Up to 25 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).||g/dL||Standard Deviation|Mean
107578|NCT00752791|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 1 - 19) and Evaluation Period (Weeks 20 -25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. One patient had the last study visit during the titration period and the transfusion after the titration period. This patient is excluded from the summary of evaluation period.|Up to 25 weeks.|Full Analysis Set.||percentage of participants||95% Confidence Interval|Number
107579|NCT00752791|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|Percentage of participants with a mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from measured at Weeks 20 to 25) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.|Baseline and Week 20 to Week 25.|Full analysis set where data was available.||percentage of participants||95% Confidence Interval|Number
107580|NCT00752791|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Week 20 to Week 25). The target hemoglobin range was 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 20 to Week 25.|Full analysis set where data was available.||percentage of participants||95% Confidence Interval|Number
107581|NCT00752791|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The primary efficacy endpoint was the mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to Enrollment and the hemoglobin on the day of Enrollment) and the Evaluation Period (mean hemoglobin from Weeks 20 to 25).|Baseline and Week 20 to Week 25.|The Full Analysis Set included all patients who received at least 1 dose of peginesatide injection and where data was available at both time points (indicated by N).||g/dL||Standard Deviation|Mean
107582|NCT00754494|Secondary|Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks|||participants|||Number
107583|NCT00754494|Secondary|Number of Participants Reported at Least 1 Rash Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks|||participants|||Number
107584|NCT00754494|Secondary|Number of Participants Reported at Least 1 Side Effect During the Study|Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.|Up to 9 weeks|||participants|||Number
107585|NCT00754494|Secondary|Normal Mucosa OSI-420 Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mg||Standard Deviation|Mean
107586|NCT00754494|Secondary|Normal Mucosa Erlotinib Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mg||Standard Deviation|Mean
107587|NCT00754494|Secondary|Plasma OSI-420 Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mL||Standard Deviation|Mean
107588|NCT00754494|Secondary|Plasma Erlotinib Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.||ng/mL||Standard Deviation|Mean
107589|NCT00754494|Secondary|ACF: Normal Mucosa pERK Ratio|Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.|Up to day 30|ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels|||||
107590|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in ACF|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
107591|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in ACF|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
107592|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in Normal Mucosa|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
107593|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in Normal Mucosa|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.||expression level||95% Confidence Interval|Geometric Mean
107594|NCT00754494|Primary|Change in ACF pERK Levels|Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.|From baseline to post-treatment (up to 30 days)|Change in ACF pERK levels not reported as the assay did not demonstrate signaling|||||
107595|NCT00754468|Secondary|Side Effects of Subjects Receiving Cryospray Therapy.||End of Study|||side effects|||Number
107596|NCT00754468|Primary|Depth of Injury|histopathological findings analyzed to determine max depth of injury (mm)|End of Study|||millimeters|Participants|80% Confidence Interval|Mean
107597|NCT00754442|Secondary|The Number of Patients With Mutations in CYP27B1|CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data|blood samples taken at baseline and sequenced over several days|All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons||participants|||Number
107598|NCT00754442|Primary|The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours|1,25-D was measured at baseline, 4 and 8 hours after PTH infusion|baseline, 4 and 8 hours after start of infusion|The final analysis was made on participants with glomerular filtration rate (GFR) of 70 and above since <70, 1,25-D production decreases. After study completion, it was noted that one participant in each group (patient and control) had GFR<70 so these two participants were excluded from final analysis.||pg/ml||Standard Deviation|Mean
107599|NCT00754390|Primary|Zinc Absorption|Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time|16 weeks|Analysis restricted to women who completed all 4 treatment periods||Percentage of Zinc-65 absorbed||Standard Error|Mean
107600|NCT00754377|Secondary|Change in Knowledge Scores About Quality Improvement|Residents' knowledge was assessed using the knowledge scale (e.g., describe change concept, how a cause-effect diagram is created, elements of the improvement model) from the SQI TAT and scores could range from 0 to 54 points. Difference scores were used based on total score of the scale with larger positive values indicating more increase in knowledge.|1 Month|||units on a scale||Standard Deviation|Mean
107601|NCT00754377|Primary|Beliefs About Ability to Implement a CQI Project|Residents' belief about their ability to implement a CQI project was measured using a single efficacy item (values ranged from 1, strongly disagree, to 5, strongly agree). The item is from the Systems Quality Improvement Training and Assessment Tool. Differences (post minus pre) in this belief item were looked at with positive and higher difference values reflecting more positive change/increase in belief.|1 month|||units on a scale||Standard Deviation|Mean
107602|NCT00754338|Primary|Lens Deposits|Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
107603|NCT00754338|Primary|Lens Wettability|Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
107604|NCT00754338|Secondary|Corneal Staining|"Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.~Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.~A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining."|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
107605|NCT00754338|Secondary|Subjective Vision|Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
107606|NCT00754338|Secondary|Dryness|Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.|4 weeks|analysis was per protocol||Units on a Scale||Standard Deviation|Mean
107607|NCT00754338|Primary|Comfort|Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.|4 weeks|analysis was per protocol||Units on a scale||Standard Deviation|Mean
107633|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
125434|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After First Treatment||immediately after first treatment|Safety||percentage of participants|||Number
107608|NCT00754325|Secondary|Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Safety Population on initial treatment; any participants that was randomized to any treatment group in the study and received at least one treatment therapy.||participants|||Number
107609|NCT00754325|Secondary|Number of Participants With Best Overall Response|Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment with measurable lesion by RECIST (Response Evaluation Criteria In Solid Tumors). Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||participants|||Number
107610|NCT00754325|Secondary|Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)|Table represents the best response achieved over this time frame. CR = Disappearance of all target lesions. No new lesions. PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||participants|||Number
107611|NCT00754325|Secondary|Percentage of Participants With Clinical Benefit for At Least 6 Months|Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination, radiological assessment, and bone scans (if applicable) were used to assess outcome.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||percentage of participants||95% Confidence Interval|Number
107612|NCT00754325|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan Meier assessments were used to estimate the percentages.|at 6 months|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||percentage of participants||95% Confidence Interval|Number
107613|NCT00754325|Secondary|Median Time of Progression-free Survival (PFS)|Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.||months||95% Confidence Interval|Median
107632|NCT00754065|Other Pre-specified|Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6|Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
110137|NCT00732940|Secondary|Median Percent Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
107614|NCT00754325|Primary|Number of Participants With Disease Progression (PD) or Death|This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included as non-responders. Censored participants = 15 Fulvestrant and Dasatinib, 9 Fulvestrant||participants|||Number
107615|NCT00754234|Primary|Nonheme Iron Absorption|Absorption was estimated from whole body retention of a Iron-59 radiotracer, 2 weeks after consuming a menu labeled with the isotope, then normalized to a ferritin of 15 nanogram/milliLiter (ng/mL)|2 weeks (wks)|Analysis was per protocol||percentage of nonheme Iron absorbed||Standard Deviation|Log Mean
107616|NCT00754156|Secondary|Blood Transfused||Duration of Hospital Stay less than 6 months|||Units||Inter-Quartile Range|Median
107617|NCT00754156|Secondary|Hospital Days||Duration of Hospital Stay less than 6 months|||Days||Inter-Quartile Range|Median
107618|NCT00754156|Secondary|ICU Days||Duration of hospital stay less than 6 months|||Days||Inter-Quartile Range|Median
107619|NCT00754156|Secondary|Days to Closure||Duration of Hospital Stay less than 6 months|||Days||Inter-Quartile Range|Median
107620|NCT00754156|Primary|Operating Room Time Utilization|The amount of time needed to manage the open abdomen inside the operating room.|Duration of Hospital Stay less than 6 months|||Minutes||Standard Deviation|Mean
107621|NCT00754156|Primary|Number of Trips to the Operating Room||12 Months|||Number of trips||Inter-Quartile Range|Median
107622|NCT00754156|Primary|Primary Closure Rate|The rate in which the abdomen was closed the first time.|up to 12 months|Descriptive Study.||% of participants|||Number
107623|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr|Geometric Mean of the Day 5 to Day 1 Accumulation Ratio|Day 5 and Day 1|All participants with pharmacokinetic measurements on Days 1 and 5||Ratio||Full Range|Geometric Mean
107624|NCT00754130|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.||participants|||Number
107625|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a t1/2 measurement||hr||Standard Deviation|Mean
107626|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a C24hr measurement||nmol/L||Standard Deviation|Mean
107627|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Tmax measurement||hr||Full Range|Median
107628|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Cmax measurement||nmol/L||Standard Deviation|Mean
107629|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with an AUC(0-24hr) measurement||nmol*hr/L||Standard Deviation|Mean
107630|NCT00754130|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.||participants|||Number
107631|NCT00754065|Other Pre-specified|The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||mm||Standard Deviation|Mean
107698|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107634|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107635|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107636|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107637|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107638|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107639|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107640|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107641|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107642|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107643|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107644|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107674|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107645|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107646|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107647|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107648|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107649|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107650|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107651|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107652|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107653|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107654|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107655|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
126209|NCT00587223|Secondary|Reduction of Intensity of Pain||through 12 weeks|no analysis performed as only 1 subject enrolled||change in pain intensity between groups|||Number
107656|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107657|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107658|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107659|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107660|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107661|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107662|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107663|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107664|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107665|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107666|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107667|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107668|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107669|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107670|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107671|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107672|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107673|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
147016|NCT00412360|Primary|Overall Survival||Year 1|||percentage of participants||95% Confidence Interval|Number
107678|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107679|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107680|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107681|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 13|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107682|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107683|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107684|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107685|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107686|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107687|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107688|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Scores on a scale||Standard Deviation|Mean
107689|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107690|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107691|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107692|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107693|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107694|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107695|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107696|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Percentage of participants|||Number
107697|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107699|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107700|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107701|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107702|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107703|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107704|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107705|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107706|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107707|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107708|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107709|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107710|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107711|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107712|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107713|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107714|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107715|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107716|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107717|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107718|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107719|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107720|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107721|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107722|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107724|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107725|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107726|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107727|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107728|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107729|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107730|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107731|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107732|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Episodes||Standard Deviation|Mean
107733|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107734|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107735|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107736|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107737|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||mm||Standard Deviation|Mean
107738|NCT00754065|Secondary|Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||mm||Standard Deviation|Mean
107739|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.|From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107762|NCT00753896|Secondary|Change in Total Cholesterol From Baseline to Week 52|Change in Total Cholesterol from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
107740|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.|From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107741|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107742|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107743|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107744|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Days||Standard Deviation|Mean
107745|NCT00754065|Secondary|The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.|From Baseline to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Tablets||Standard Deviation|Mean
107746|NCT00754065|Secondary|The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.|From Baseline to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure||Tablets||Standard Deviation|Mean
107747|NCT00754065|Primary|The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in Full Analysis Set (FAS) with assessment for this outcome measure||mm||Standard Deviation|Mean
107763|NCT00753896|Secondary|Change in Body Weight From Baseline to Week 52|Change in body weight from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||kg||Standard Error|Mean
107764|NCT00753896|Secondary|Change in Fasting Serum Glucose From Baseline to Week 52|Change in fasting serum glucose from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
107748|NCT00754013|Secondary|Mean Change From(Baseline) to Visit 3(Week 10 or Early Termination) in VABS-II/PCRF Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The planned secondary objectives of the study included further evaluation of efficacy as assessed by additional analyses of the VABS-II/PCRF, by analyses of the Test of Verbal Expression and Reasoning (TOVER), a subject-performance-based measure of expressive language function, and by the Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent. In addition, observed case analyses of these assessments at Week 4 and Week 10 were planned.|Visit 1 (Baseline) to Visit 3 (Week 10 or early termination).|This study was terminated early. Secondary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.|||||
107749|NCT00754013|Primary|Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The primary objective of the study was evaluation of the efficacy and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down syndrome (DS), aged 6 to 10, as assessed by analysis of VABS-II/PCRF in the domains of communication, daily living skills, and socialization, and as assessed by standard safety measurements.|Visit 0 (Screen), Visits 1 (Baseline), 2, and 3 (or Early Termination).|The planned efficacy analysis was on the intent-to-treat (ITT) population. This study was terminated early. Primary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.|||||
107750|NCT00753948|Secondary|Methacholine Challenge||During study visits, methacholine challenge will be performed 120 minutes post intervention.||||||
107751|NCT00753948|Secondary|Lung Function as Measured by Plethysmography||During study visits, measures are obtained prior to intervention (intravenous or nebulized) and 60, 120 minutes post intervention.||||||
107752|NCT00753948|Primary|Exhaled Levels of Nitric Oxide|Nitric Oxide was measured applying a real time technique for measurement of Nitric Oxide in Exhaled Breath Condensate. Elevated Nitric Oxide in exhalate is a measure of elevated production of NO in conditions such as underlying inflammation and/or oxidative stress|Exhaled NO was reported as the mean of three values within 10% of each other.|||ppb (parts per bilion)||Standard Deviation|Mean
107753|NCT00753922|Post-Hoc|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications|The safety analyses were conducted in accordance with the FDA November 17, 2006 “Guidance for Industry and FDA Staff – Saline, Silicone Gel, and Alternative Breast Implants.” The study investigator assessed any complications durign study follow-up visits in alignment with this guidance. Time of occurrence was calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. Complications with an incidence > 5.0% are reported.|10 years|All Enrolled Subjects||percentage of subjects||95% Confidence Interval|Number
107754|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects||percentage of subjects||95% Confidence Interval|Number
107755|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects||percentage of subjects||95% Confidence Interval|Number
107756|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 Years|All enrolled subjects||percentage of subjects||95% Confidence Interval|Number
107757|NCT00753922|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects||centimeters||Standard Deviation|Mean
107758|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included||percentage of subjects||95% Confidence Interval|Number
107759|NCT00753896|Secondary|Change in Blood Pressure From Baseline to Week 52|Change in Systolic and Diastolic Blood Pressure from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmHg||Standard Error|Mean
107760|NCT00753896|Secondary|Change in Triglycerides From Baseline to Week 52|Change in Triglycerides from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
107761|NCT00753896|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 52|Change in HDL from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Mean
140253|NCT00467285|Secondary|CTx|% Change in bone turnover markers at 6 month follow up compared to baseline|6 months|||pg/mL||Standard Deviation|Mean
107765|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 52|Percentage of patients achieving HbA1c <=6.5% at endpoint (for patients with HbA1c >6.5% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 6.5%. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
107766|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 52|Percentage of patients achieving HbA1c <=7% at endpoint (for patients with HbA1c >7% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 7% . Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
107767|NCT00753896|Secondary|Change in HbA1c From Baseline to Week 52|Change in HbA1c from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of total hemoglobin||Standard Error|Mean
107768|NCT00753896|Primary|Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.||events per subject-year||Standard Error|Mean
107769|NCT00753896|Primary|Percentage of Patients Experiencing Adverse Events|Percentage of patients experiencing treatment-emergent adverse events over 52 weeks|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.||percentage of patients|||Number
107770|NCT00752726|Secondary|Selectivity Index at Week 24|The selectivity index (SI) was used as a measure of orlistat’s ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment, only in Orlistat 60 mg group. This analysis was not carried out for placebo group.||Ratio|||Number
107771|NCT00752726|Secondary|Change From Baseline to Week 24 in Quality of Life (QoL) Scores.|QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.|Baseline to week 24|This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.||Score on a Scale||Standard Deviation|Mean
107772|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Calories Expended for Physical Activity|Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||Kilocalorie (kcal)/week||Standard Deviation|Mean
107773|NCT00752726|Secondary|Change From Baseline to Week 24 in Liver Fat|The liver fat was measured by CT scan in Hounsfield Units (HU).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||Hounsfield Units (HU)||Standard Deviation|Mean
107774|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Liver Fat|For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).|Baseline to week 24|ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.||Percentage (%) IHL||Standard Deviation|Mean
107775|NCT00752726|Secondary|Change From Baseline to Week 24 in Waist Circumference|Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||cm||Standard Deviation|Mean
107776|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Body Fat|Body fat was assessed through Bioelectrical Impedance Analysis (BIA).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||Percentage (%) body fat||Standard Deviation|Mean
107777|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Fat Mass|Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
107778|NCT00752726|Secondary|Change From Baseline to Week 24 in Body Weight|Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
107779|NCT00752726|Secondary|Change From Baseline to Week 12 in Abdominal VAT Mass|Abdominal VAT mass from baseline to week 12 was measured by CT scan.|Baseline to week 12|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
140782|NCT00462826|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
107780|NCT00752726|Primary|Change From Baseline to Week 24 in Abdominal VAT Mass|VAT was measured by the computed tomography (CT) scan.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.||kg||Standard Deviation|Mean
107781|NCT00753766|Secondary|Rate of Return to the Operating Room||6 weeks||||||
107782|NCT00753766|Secondary|A Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia||6 weeks||||||
107783|NCT00753766|Secondary|Length of Hospital Stay||6 weeks||||||
107784|NCT00753766|Secondary|Occurrence of Wound Infection in the 30 Day Post-operative Period||6 weeks||||||
107785|NCT00753766|Secondary|Change in A1c & Fructosamine From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control, Fructosamine Provides a Measure of Shorter-term Glucose Control [2-3 Wks])||6 weeks||||||
107786|NCT00753766|Secondary|Percent of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications||6 weeks|||participants|||Number
107787|NCT00753766|Secondary|Participant Adherence With the Study Protocol (i.e. Attending Study Visits, CGMS Studies||6 weeks||||||
107788|NCT00753766|Primary|Percent of Screened Participants That Are Eligible and Choose Participation||6 weeks|||percentage of potential participants|||Number
107789|NCT00753714|Secondary|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes|Oct 2008- Dec 2011|||Adverse Events|||Number
107790|NCT00753714|Secondary|Duration of Response||Oct 2008- dec 2011|||days||95% Confidence Interval|Median
107791|NCT00753714|Secondary|Overall Objective Response||Oct 2008- dec 2011|||Participants|||Number
107792|NCT00753714|Secondary|Overall Survival||Oct 2008- dec 2011|||days||95% Confidence Interval|Median
107793|NCT00753714|Primary|Progression Free Survival||Oct 2008- dec 2011|||days||95% Confidence Interval|Median
107794|NCT00753688|Secondary|Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal [LLN]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).|Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||participants|||Number
107795|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin|Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||participants|||Number
107796|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count|Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||participants|||Number
107797|NCT00753688|Secondary|Change From Baseline in Heart Rate|Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||beats per minute||Standard Deviation|Mean
107798|NCT00753688|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in on-therapy SBP and DBP was calculated as the values at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population: all participants who had started their allocated treatment (at least one dose of the study drug). Data were analyzed for participants who were on-therapy and provided data at the indicated time point.||Millimeters of mercury||Standard Deviation|Mean
107828|NCT00753545|Secondary|FACT-O Symptom Index (FOSI) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression|||months||95% Confidence Interval|Median
140783|NCT00462826|Primary|Objective Tumor Response||At 6 months||||||
107799|NCT00753688|Secondary|PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization [WHO] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)|"ITT Population. The ns in the category titles represent the number of participants in each treatment arm with the indicated STS."||weeks||95% Confidence Interval|Median
107800|NCT00753688|Secondary|Duration of Response Assessed by the Independent Radiologist and the Investigator|Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.||weeks||95% Confidence Interval|Median
107801|NCT00753688|Secondary|Time to Response Assessed by an Independent Radiologist and the Investigator|Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.||weeks||95% Confidence Interval|Median
107802|NCT00753688|Secondary|Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator|Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).|From the start of treatment until disease progression (assessed for an average of 10 months)|ITT Population||participants|||Number
107803|NCT00753688|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent [%]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.|From the date of randomization until 215 deaths (assessed for an average of 12 months)|ITT Population||months||95% Confidence Interval|Median
107804|NCT00753688|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)|Intent-to-Treat (ITT) Population: all randomized participants analyzed in the treatment arm they were allocated by randomization.||weeks||95% Confidence Interval|Median
107805|NCT00753675|Secondary|Overall Survival|OS is defined from the date of randomization to death|up to 1032 days|ITT||Days||95% Confidence Interval|Median
107806|NCT00753675|Secondary|Duration of Response (DOR)|DOR is defined from the date of first documentation of response until date of PD or death|up to 1032 days|ITT (best response of CR or PR only)||Days||95% Confidence Interval|Median
107807|NCT00753675|Secondary|Disease Control Rate (CR+PR+SD)|DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis|up to 1032 days|ITT||Partecipants|||Number
107808|NCT00753675|Secondary|Objective Tumor Response Rate (CR+PR),|Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD|up to 1032 days|ITT||Participants|||Number
107809|NCT00753675|Primary|Progression Free Survival|Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).|up to 1032 days|ITT||days||95% Confidence Interval|Median
107810|NCT00753649|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to Last subject last visit on 03/12/2013|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.||Subjects|||Number
107885|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|30 days|Intent to Treat population||percentage of limbs|Participants||Number
126210|NCT00587223|Secondary|Recurrence of Epidermolysis Bullosa (EB) Lesions||through 12 months|no analysis performed as only 1 subject enrolled||proportion (%) of treated wounds|||Number
107811|NCT00753649|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day (Days 0-30) post vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.||Subjects|||Number
107812|NCT00753649|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
107813|NCT00753649|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL|The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
107814|NCT00753649|Secondary|Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)|A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
107815|NCT00753649|Secondary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
107816|NCT00753649|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL|For this assay, 1 μg/mL was considered as the seropositivity cut-off.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
107817|NCT00753649|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.||Subjects|||Number
107818|NCT00753636|Secondary|Pharmacokinetic Data – Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine|Mean Plasma Concentration (+/- SD ng/mL)|1 year|||ng/mL||Standard Deviation|Mean
107819|NCT00753636|Secondary|Change in Motor UPDRS Scores: Baseline vs. Final Visit|"Baseline visit = Week 0 Final visit = Week 12~Unified Parkinson's Disease Rating Scale (UPDRS)is made up of the following sections:~Part I: evaluation of Mentation, behavior, and mood Part II: self evaluation of the activities of daily life Part III: clinician-scored motor evaluation Part IV: Hoehn and Yahr stating of severity of Parkinson disease. Part V: Schwab and England ADL scale Only part three was used for this assessment.~The higher the UPDRS score, the greater the disability from PD.~The range for scores for Section III is 0 to 108."|12 weeks|||UPDRS Part III Score||Standard Deviation|Mean
107820|NCT00753636|Secondary|Number of Participants That Completed the Study at Each Dose Level of Isradipine||1 year|||Participants|||Number
107821|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent|"At the time of enrollment, some patients were currently being treated with antihypertensive agents including Propanolol, Toprol, Lisinopril, Diovan, Norvasc.~HTN+: Participants on an antihypertensive agent HTN-: Participants not on an antihypertensive agent"|1 year|||Participants|||Number
107822|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose of Isradipine|Tolerability= maximum tolerated dose|1 year|||Participants|||Number
107823|NCT00753636|Secondary|Safety of the Standard Titration Schedule in PD Population as Measured by the Number of Patients That Are Able to Increase the Dose to 20 mg Daily||1 year|||Participants|||Number
107824|NCT00753636|Primary|Tolerability of Isradipine Based on the Number of Participants That Complete the Study||1 year|||Participants|||Number
107825|NCT00753623|Primary|Visual Analog Scale for Pain (0-10).|Subjects were asked to rate their pain on the Visual Analog Scale for pain, with 0 being no pain and 10 being the worst pain they can imagine.|Participants were followed for up to 5 weeks.|Of the 23 subjects enrolled, only 16 subjects completed. The data set was not large enough to conduct statistical analysis for significance.|||||
107826|NCT00753545|Secondary|Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression|||months||95% Confidence Interval|Median
107827|NCT00753545|Secondary|Trial Outcome Index(TOI)Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression|||months||95% Confidence Interval|Median
110138|NCT00732940|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||mmol/L||Standard Error|Mean
107829|NCT00753545|Secondary|Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression|Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline||percentage of evaluable participants|||Number
107830|NCT00753545|Secondary|Improvement Rate for Trial Outcome Index (TOI)|The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression|Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline||percentage of evaluable participants|||Number
107831|NCT00753545|Secondary|Improvement Rate for FACT-O Symptom Index (FOSI)|The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression|Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline||percentage of evaluable participants|||Number
107832|NCT00753545|Secondary|Time to Earlier of CA-125 or RECIST Progression|Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements|||Months||95% Confidence Interval|Median
107833|NCT00753545|Secondary|RECIST and CA-125 Response Separately and Combined|RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements|||Participants|||Number
107834|NCT00753545|Secondary|Best Objective Response|Best overall response from radiologic assessments. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter|||Participants|||Number
107835|NCT00753545|Secondary|Best Percentage Change in Cancer Antigen 125 (CA-125) Levels|Best percentage change from baseline in CA-125 level|CA-125 was measured at baseline then every 28 days on treatment|A subset of the FAS with baseline and at least 1 follow-up value of CA-125||percentage of change||Full Range|Median
107836|NCT00753545|Secondary|Percentage Change From Baseline in Tumour Size at Week 24|Percentage change from baseline to Week 24 in target tumour size.|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.||percentage of change||Full Range|Median
107837|NCT00753545|Secondary|Duration of Response|Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only].|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter|||Months||Full Range|Median
107838|NCT00753545|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter|||percentage of participants|||Number
107839|NCT00753545|Secondary|Objective Response Rate (ORR) (According to RECIST)|For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline||percentage of participants|||Number
107840|NCT00753545|Secondary|Overall Survival (OS)|OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive. [FAS] There were insufficient events to calculate median OS or perform formal statistical analysis so percentage of patients who died are shown along with 95% confidence intervals.|Follow up every 8 weeks post progression|||percentage of participants||95% Confidence Interval|Number
107841|NCT00753545|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter|||months||95% Confidence Interval|Median
107842|NCT00753519|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment).|baseline, 1 day post iTBS|||units on a scale||Standard Deviation|Mean
107843|NCT00753519|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|baseline, 1 day post iTBS|||units on a scale||Standard Deviation|Mean
107886|NCT00753337|Secondary|Procedure Success|Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)|9 months|Intent to Treat population||percentage of participants|||Number
107844|NCT00753519|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post iTBS|||seconds||Standard Deviation|Mean
107845|NCT00753519|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real iTBS and sham iTBS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline, 1 day post intervention, and 1 month post intervention.|baseline, 1 day post iTBS|||seconds||Standard Deviation|Mean
107846|NCT00753506|Secondary|Change in Cognitive Functioning as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status and Change in Functional Performance as Measured by the UCSD Performance-based Skills Assessment.||10 weeks (weeks 2 & 12)||||||
107847|NCT00753506|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale. PANSS positive symptom scores and negative symptom scores each range from 7 to 49 units on a scale.|10 weeks (weeks 2 & 12)|||units on a scale||Standard Deviation|Mean
107848|NCT00753454|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."||units on a scale||Standard Deviation|Mean
107849|NCT00753454|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."||units on a scale||Standard Deviation|Mean
107850|NCT00753454|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."||units on a scale||Standard Deviation|Mean
107851|NCT00753454|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."||units on a scale||Standard Deviation|Mean
107852|NCT00753454|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
107853|NCT00753454|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
107887|NCT00753337|Secondary|Lesion Success|Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.|9 months|Intent to Treat population||percentage of lesions|Participants||Number
145254|NCT00425269|Secondary|Body Mass Index, Post-test||post-test, after completion of all six group sessions|||kg/m^2||95% Confidence Interval|Mean
107854|NCT00753454|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
107855|NCT00753454|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
107856|NCT00753454|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."||units on a scale||Standard Deviation|Mean
107857|NCT00753454|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
107858|NCT00753454|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
107859|NCT00753454|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."||units on a scale||Standard Deviation|Mean
107860|NCT00753454|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."||units on a scale||Standard Deviation|Mean
107861|NCT00753454|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."||units on a scale||Standard Deviation|Mean
107862|NCT00753454|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis.~Data was not available for 16 subjects."||percentage of subjects|||Number
107888|NCT00753337|Secondary|Device Success|Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|9 months|Intent to Treat population||percentage of lesions|Participants||Number
107863|NCT00753454|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis.~Data was not available for 17 subjects."||percentage of subjects|||Number
107864|NCT00753454|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis.~Data was not available for 19 subjects."||percentage of subjects|||Number
107865|NCT00753454|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis.~Data was not available for 22 subjects."||units on a scale||Standard Deviation|Mean
107866|NCT00753454|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis.~Data was not available for 23 subjects."||units on a scale||Standard Deviation|Mean
107867|NCT00753454|Secondary|Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."||units on a scale||Standard Deviation|Mean
107868|NCT00753454|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."||percentage of subjects|||Number
107869|NCT00753454|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."||percentage of subjects|||Number
107870|NCT00753454|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."||percentage of subjects|||Number
107889|NCT00753337|Secondary|Primary Patency Rate at 9 Months|Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.|9 months|Intent to Treat population||percentage of lesions|Participants||Number
107871|NCT00753454|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|"A Serious Adverse Event is any untoward medical occurrence that at any dose~results in death,~is life threatening,~requires in-patient hospitalization or prolongation of existing hospitalization,~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect"|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.||percentage of subjects|||Number
107872|NCT00753454|Primary|Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.||percentage of subjects|||Number
107873|NCT00753454|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.||percentage of subjects|||Number
107874|NCT00753415|Secondary|Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)|An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.|From pre-vaccination to Week 69|Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.|||||
107875|NCT00753415|Primary|Number of Participants With Adverse Events (AEs)|This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|All Participants as Treated (APaT) population; all participants who received at least one vaccination.||Participants|||Number
107876|NCT00753415|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.||Participants|||Number
107877|NCT00753363|Secondary|Fitness|Maximal oxygen consumption (VO2max) on a treadmill|Baseline and 6 month|||L/min||Standard Error|Mean
107878|NCT00753363|Secondary|Body Weight||Baseline and 6 month|||kg||Standard Error|Mean
107879|NCT00753363|Primary|Insulin Sensitivity|Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration. Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity. This is one of the most sophisticated methods to measure insulin sensitivity.|Baseline and 6 month|||μmol/kgFFM/min||Standard Error|Mean
107880|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.|9 months|Intent to Treat population||participants|||Number
107881|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.|30 days|Intent to Treat population||participants|||Number
107882|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|9 months|Intent to Treat population||percentage of limbs|Participants||Number
107883|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|30 days|Intent to Treat population||percentage of limbs|Participants||Number
107884|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|9 months|Intent to Treat population||percentage of limbs|Participants||Number
110139|NCT00732940|Secondary|Median Percent Change From Baseline in HDL at Week 24||Baseline, 24 week|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
107890|NCT00753337|Primary|Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).|Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.|9 months|Intent to Treat population (ITT)||percentage of participants|||Number
107891|NCT00753298|Primary|Subject's Sensation When Using Test Catheter|Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)|At 4 weeks|||Score on scale||Standard Deviation|Mean
107892|NCT00753298|Primary|Subject's General Satisfaction With Test Catheter|Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)|At 4 weeks|||Score on scale||Standard Deviation|Mean
107893|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter After Withdrawal|Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
107894|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Withdrawal|Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
107895|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Insertion|Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
107896|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter Before Insertion|Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks|||Score on scale||Standard Deviation|Mean
107897|NCT00753272|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains|In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.|At Day 21 of the first year (2008/2009) of the study.|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.||Subjects|||Number
107898|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the second year of the study.||Titers||95% Confidence Interval|Geometric Mean
107899|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the first year of the study.||Titers||95% Confidence Interval|Geometric Mean
107900|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the second year of the study.||Titers||95% Confidence Interval|Geometric Mean
107901|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the first year of the study.||Titers||95% Confidence Interval|Geometric Mean
107902|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
108219|NCT00749190|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS. Imputation method used was the classical LOCF (CLOCF) approach which uses always the last available value.||percentage of HbA1c||Standard Error|Mean
107903|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
107904|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
107905|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
107906|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Days||Full Range|Mean
107907|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
107908|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Days||Full Range|Mean
107909|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
107910|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Days||Full Range|Mean
107911|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.||Subjects|||Number
107912|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Days||Full Range|Mean
109161|NCT00738673|Secondary|Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||ng/mL||Standard Deviation|Mean
107913|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.||Subjects|||Number
107914|NCT00753272|Secondary|Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.~Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
107915|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
107916|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)|The Two-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented in each year of the study||Subjects|||Number
107917|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)|The One-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented during the first year of the study.||Subjects|||Number
107918|NCT00753272|Secondary|Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine|Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.||Subjects|||Number
107919|NCT00753272|Secondary|Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.|The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.||Subjects|||Number
107920|NCT00753272|Secondary|Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.|"Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough.~The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v)."|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.||Subjects|||Number
107921|NCT00753272|Secondary|Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.|Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.||Subjects|||Number
145255|NCT00425269|Secondary|Waist Circumference||post-test, after completion of all six group sessions|||cm||95% Confidence Interval|Mean
107922|NCT00753272|Secondary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.||Subjects|||Number
107923|NCT00753272|Primary|Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.||Titers||95% Confidence Interval|Geometric Mean
107924|NCT00753272|Primary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))|The One-Dose According-To-Protocol cohort for efficacy included eligible subjects from the One-Dose Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.||Subjects|||Number
107925|NCT00753220|Primary|Maximum Tolerated Dose (MTD)|"PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer.~ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD."|Up to 1 year|||intratumorally delivered cells|||Number
107926|NCT00753142|Secondary|To Determine if Hyperglycemia-induced Reduced Insulin Secretion is the Result of Beta-cell Exhaustion or Beta-cell Desensitization.||4 years||||||
107927|NCT00753142|Primary|First Phase Insulin Release (FPIR)|Calculated as the sum of the insulin levels at 2, 3, 4, and 5 min after infusion|at the end of 20 hours|||microunits/ml||Standard Deviation|Mean
107928|NCT00753012|Primary|Blood Pressure at Maximum Exertion|Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET)|3-6 months|||mmHg||Standard Deviation|Mean
107929|NCT00753012|Primary|Cardiac Function Index (E/A Ratio)|Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months|||cm/sec/cm/sec||Standard Deviation|Mean
107930|NCT00753012|Primary|Left Ventricle Size|Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months|14 subjects completed endpoint TTE; one HTN subject missed the scheduled endpoint TTE appointment.||mm||Standard Deviation|Mean
107931|NCT00752986|Secondary|Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes||Continuous assessment of safety.||||||
107932|NCT00752986|Secondary|Overall Survival||Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.||||||
107933|NCT00752986|Secondary|Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)||Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.||||||
107934|NCT00752986|Primary|Event Free Survival|Success rate (patients without progression and still on treatment at 24 weeks|Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.||||||
107935|NCT00752973|Secondary|Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.|To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects).||participants|||Number
107936|NCT00752973|Primary|Participants Clinically Cured of Head Lice 14 Days After Last Treatment|No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).|Day 7±1 and Day 14 or Day 21|No statistical analysis provided for Clinical Cure||participants cured of lice|||Number
108248|NCT00748709|Secondary|Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation|Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation|First administration of trial medication until 28 days after last administration of trial medication|TS||Participants|||Number
107937|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 24 hrs (Day 1)|||percentage of participants|||Number
107938|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 1 hr (Day 0)|||percentage of participants|||Number
107939|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participant had wheezing as medical history which continued without increase in severity throughout the treatment."|at Baseline|||percentage of participants|||Number
107940|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).|"Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent reduction = (Post treatment value – Baseline)/ Baseline x100."|Change from baseline to 24 hrs (1 day)|11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts.||percentage change in cholinesterase||95% Confidence Interval|Mean
107941|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).|"Each patient (aged 6 – 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals.~If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent change (reduction) = (Post treatment value – Baseline)/ Baseline x100."|Change from Baseline to 1 hour|"10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0.~subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts."||percentage change in cholinesterase||95% Confidence Interval|Mean
107942|NCT00752895|Secondary|Number of Antibiotic Use Days|An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.|3 months|Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.||days||Standard Deviation|Mean
107943|NCT00752895|Primary|Acute Respiratory Infection (ARI) Days|An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.|3 months|Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.||days||Standard Deviation|Mean
107944|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission Off Steroids in the Interventional Phase|"Number of participants who were in clinical remission and off systemic corticosteroids at visit.~The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
107945|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
107946|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI-100 at Weeks 14-16, 24 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 100-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
108449|NCT00746863|Secondary|In-hospital Medication Amounts|Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.|From surgery until discharge, average|||number of pills||Standard Deviation|Mean
107947|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI at Weeks 14-16 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 70-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at week 14-16 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
107948|NCT00752622|Secondary|Number of Participants That Required Treatment Optimization in the Observational Phase|"Participants required treatment-optimization if:~Disease progression/lack of response after entering observational phase; or~Participant was successfully randomized into the interventional phase~The definition of loss of response was as follows:~- An increased HBI score >= 3 points over the week 10 evaluation score and a CDAI score >= 175.~Despite:~having received regular infusions of infliximab every 8 weeks during the observational phase with a maximum interval of no > 10 weeks between each infusion, and~having received previous doses of infliximab of >= 4.7 mg/kg."|Week 54 in the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication. Of the 98 participants in the ELIG population, 65 participants entered the observational phase.||Participants|||Number
107949|NCT00752622|Primary|Mean Change From Baseline in Harvey-Bradshaw Index (HBI)|Mean change in HBI score from Baseline to Week 10, 30, and 54. HBI score consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is the sum of individual parameters. Minimum score is 0 and no pre-specified maximum score as it depends on the number of liquid stools. Lower scores indicate better well being. Clinical response/ long-term response is defined as a decrease by 3 or more points from baseline value. Loss of response is defined as an increase of >= 3 points.|Baseline and Evaluation Week 10, Week 30 and Week 54 of the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
107950|NCT00752622|Primary|Number of Participants Who Had a Clinical Response Using the Crohn's Disease Activity Index (CDAI) at Week 24 in the Interventional Phase|The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Participants provided completed CDAI diary cards and were considered as responders in the interventional phase if their CDAI score at week 24 was decreased by 70 points or greater over their CDAI score at randomization into the interventional phase, or if their week 24 CDAI score is <= 150. Baseline is value at randomization.|Baseline and Week 24 of the Interventional phase|Due to the early termination of the study, no participants completed the Interventional phase.|||||
107951|NCT00752609|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 20|Safety Analysis set, which included all patients who received at least 1 dose of study drug. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.||percentage of participants|||Number
107952|NCT00752609|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals.|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full analysis set where data was available for each time interval (indicated by N).||percentage of participants||95% Confidence Interval|Number
107953|NCT00752609|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24).|Up to 24 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).||g/dL||Standard Deviation|Mean
107954|NCT00752609|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full Analysis Set.||percentage of participants||95% Confidence Interval|Number
107955|NCT00752609|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|"Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Baseline and Week 19 to Week 24.|Full analysis set where data was available.||percentage of participants||95% Confidence Interval|Number
107956|NCT00752609|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 19 to Week 24|Full Analysis Set where data was available.||percentage of participants||95% Confidence Interval|Number
108527|NCT00745823|Secondary|Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96||||||
154031|NCT00352755|Secondary|Progression-free Survival||Median follow-up was 32 months|||months||Full Range|Median
107957|NCT00752609|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).|Baseline and Week 19 to Week 24.|The Full Analysis Set including all patients who received at least 1 dose of study drug where data was available (indicated by N).||g/dL||Standard Deviation|Mean
107958|NCT00752232|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
107959|NCT00752232|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Z-score||Standard Deviation|Mean
107960|NCT00752232|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
107961|NCT00752232|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).||Units on a scale||Standard Deviation|Mean
107962|NCT00752232|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geometric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
107963|NCT00752232|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.||Units/mL||95% Confidence Interval|Geometric Mean
107964|NCT00752232|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
107965|NCT00752232|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
107966|NCT00752232|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.||Participants|||Number
107967|NCT00752128|Secondary|Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition||12 Months|Intention to treat||percentage of participants|||Number
107968|NCT00752128|Primary|Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)||12 Months|Analysis per intention to treat||percentage of participants|||Number
145256|NCT00425269|Secondary|Diastolic Blood Pressure, Post-test||post-test, after completion of all six group sessions|||mmHg||95% Confidence Interval|Mean
107969|NCT00752089|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"PP population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."||ug*F/cm^3||95% Confidence Interval|Least Squares Mean
107970|NCT00752089|Primary|Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Per-Protocol (PP) population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."||% SMHR||95% Confidence Interval|Least Squares Mean
107971|NCT00751998|Secondary|Health Resources Utilization (Health Economics)||Procedure through end of study.||||||
107972|NCT00751998|Secondary|Device Durability and Device Performance.||Procedure||||||
107973|NCT00751998|Secondary|Safety||Procedural through end of study||||||
107974|NCT00751998|Secondary|Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures.||Post Procedure||||||
107975|NCT00751998|Secondary|Ability to Visualize and Access Various Targeted Anatomic Areas.||Procedure||||||
107976|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management.||Procedure or at 12 months||||||
107977|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis.||Procedural through end of study||||||
107978|NCT00751998|Primary|Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.||During Procedure|||percent||95% Confidence Interval|Number
107979|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D|"The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome.~The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.~Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL||units on a EuroQol EQ-5D scale||Standard Deviation|Mean
107980|NCT00751972|Secondary|Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days|"The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue.~A longer distance walked is indicative of a better outcome."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of 6 minute walk distance.||meters||Standard Deviation|Mean
107981|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|"KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQ’s questions are used to calculate scores in ten domains:~Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL.||units on a KCCQ scale||Standard Deviation|Mean
107982|NCT00751972|Secondary|Incidence of All Device Failures and Device Malfunctions|The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||Number of events|||Number
107983|NCT00751972|Secondary|Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects|Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||percentage of patients|||Number
107984|NCT00751972|Secondary|Survival to 180 Days|All subjects will be followed for date of death until 180 days.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||Percentage of participants with survival|||Number
108528|NCT00745823|Secondary|Number of Participants With One or More Adverse Events at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96||||||
145257|NCT00425269|Secondary|Systolic Blood Pressure, Post-test||post-test, after completion of all six group sessions|||mmHg||95% Confidence Interval|Mean
107985|NCT00751972|Primary|The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.|The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.|180 days|The primary effectiveness analyses was performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).||Percentage of participants with success|||Number
107986|NCT00751933|Secondary|Symptom Score Improvement of 2 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months||||||
107987|NCT00751933|Primary|Symptom Score Improvement of 3 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months||||||
107988|NCT00751881|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);~Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin (TB) >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."||participants|||Number
107989|NCT00751881|Secondary|Extension Treatment Period: ARR: Poisson Regression Estimate|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. A relapse is defined as the appearance of a new clinical sign/symptom or clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persists for a minimum of 24 hours in the absence of fever. Relapse was confirmed by an increase in EDSS score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.||relapses per year||95% Confidence Interval|Number
107990|NCT00751881|Secondary|Extension Treatment Period: Time to Disability Progression|"Probability of disability progression since the randomization of the core period was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12 week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event free for the amount of time t. Probability of event at time t was 1 minus the probability of being event-free for the amount of time t."|Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.||percent probability||95% Confidence Interval|Number
107991|NCT00751881|Secondary|Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|"Safety population: all randomized participants who received at least 1 dose of investigational product.~Two participants in placebo of core study received teriflunomide and were analyzed according to teriflunomide dose.~One participant in teriflunomide 14 mg in core study group who received 7 mg was analyzed in teriflunomide 7 mg group."||participants|||Number
107992|NCT00751881|Secondary|Core Treatment Period: Overview of Adverse Events|Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."||participants|||Number
107993|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
108003|NCT00751777|Primary|Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|"Definition of SCR:~Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline~Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline"|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.||percentage of participants||95% Confidence Interval|Number
107994|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|"SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.~Two summary scores are obtained:~the physical health component summary score,~the mental health component summary score.~Both scores range from 0 to 100 and a high score indicates a more favorable health state.~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures [MMRM] on each summary score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
107995|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
107996|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score|"FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
107997|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score|"EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.~EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).~Baseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48|Intent-to-treat population||units on a scale||Standard Error|Least Squares Mean
107998|NCT00751881|Secondary|Core Treatment Period: Time Without Relapse|"Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse.~Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population||percent probability||95% Confidence Interval|Number
107999|NCT00751881|Secondary|Core Treatment Period: Time to Disability Progression|"Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population||percent probability||95% Confidence Interval|Number
108000|NCT00751881|Primary|Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate|"ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.||relapses per year||95% Confidence Interval|Number
108001|NCT00751790|Secondary|LH Increase|% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts|day 1 and day 169||||||
108002|NCT00751790|Primary|Achievement of Castration and Maintenance of Castration|Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).|at Day 29|||percentage of enrolled patients|||Number
108034|NCT00751400|Secondary|Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days|This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing|1 month|number of subjects reporting at least one tablet taken at any point during study||participants|||Number
108004|NCT00751777|Primary|Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.||ratio||95% Confidence Interval|Number
108005|NCT00751777|Secondary|Evaluation of Duration of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group||13 months||||||
108006|NCT00751777|Secondary|Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear||1 month||||||
108007|NCT00751777|Secondary|Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch||7 months||||||
108008|NCT00751777|Primary|Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo||Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.||geometric mean titer||95% Confidence Interval|Geometric Mean
108009|NCT00751634|Secondary|Number of Participants With Arrhythmia|New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm|Six hours|||participants|||Number
108010|NCT00751634|Secondary|Number of Participants With Hypotension|New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period|six hours|||participants|||Number
108011|NCT00751634|Secondary|Number of Participants With Severe Shivering|"Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall~Mild: shivering localized to the neck and/or thorax only~Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)~Severe: shivering involves gross movements of the trunk and upper and lower extremities"|six hours|All participants were analyzed for the outcome of BSAS=3||participants|||Number
108012|NCT00751634|Secondary|Time From Start of Cooling Device to Core Temperature < 100.4F|For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F|Six hours|||hours||Standard Deviation|Mean
108013|NCT00751634|Primary|Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care|Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.|baseline, one, two and six hours after application.|||degrees F||Standard Deviation|Mean
108014|NCT00751621|Secondary|Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion|The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period.||AEs per infusion|Participants||Number
108015|NCT00751621|Secondary|Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.|The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom laboratory parameter data was collected at both baseline and completion.||participants|||Number
108016|NCT00751621|Secondary|Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.|The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom vital signs data was collected at both baseline and completion.||participants|||Number
108017|NCT00751621|Secondary|Health Related Quality of Life (Short Form 36 Health Survey)|The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At baseline and at the last available post-baseline observation for each subject (up to 42 months)|The analysis population comprised the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.||score on a scale||Full Range|Median
108018|NCT00751621|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days per subject year|Participants||Number
108019|NCT00751621|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days|||Number
108020|NCT00751621|Secondary|Annualized Rate of Hospitalization Due to Infections|The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days per subject year|Participants||Number
108021|NCT00751621|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days|||Number
108022|NCT00751621|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||days per subject year|Participants||Number
108023|NCT00751621|Secondary|Number of Infection Episodes|Total number of infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||infection episodes|||Number
108024|NCT00751621|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||infection episodes per subject year|Participants|95% Confidence Interval|Number
108025|NCT00751621|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs."|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||SBIs per subject year|Participants||Number
108026|NCT00751621|Primary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Up to 42 months|The “all treated” (AT) safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the “Full Analysis/intention-to-treat” (ITT) data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.||g/L||Standard Deviation|Mean
108027|NCT00751530|Secondary|Percentage of Participants Using Etravirine in Background Regimen|These results report the percent of participants using Etravirine in the background regimen.|Background regimen (no specific time frame)|||Percentage of Participants|||Number
108028|NCT00751530|Primary|Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 Weeks|||Percentage of Participants|||Number
108029|NCT00751530|Secondary|Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)|The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.|Baseline|||score||Full Range|Mean
108030|NCT00751530|Secondary|CD4 Cell Changes Among Participants in PI vs Non-PI Group|CD4 cell counts were measured using standard of care testing via local laboratories.|baseline to 24 Weeks|||cells/mm3||Full Range|Mean
108031|NCT00751530|Secondary|Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 weeks|||Percentage of participants|||Number
108032|NCT00751400|Secondary|Number of Dosing Occasions Per Subject That Exceeded 660 mg|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||dosing occasions||Standard Deviation|Mean
108033|NCT00751400|Secondary|Number of Total Dosing Occasions Per Subject|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||dosing occasions||Standard Deviation|Mean
108035|NCT00751400|Secondary|Average Daily Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||mg||Standard Deviation|Mean
108036|NCT00751400|Secondary|Number of Subjects With and Without More Than 660 mg at Least Once|This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||participants|||Number
108037|NCT00751400|Secondary|Number of Subjects With and Without Next Dose Less Than 22 Hours Later|This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||participants|||Number
108038|NCT00751400|Secondary|Number of Subjects With and Without More Than One Tablet Taken Per Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||participants|||Number
108039|NCT00751400|Secondary|Use Days With and Without Next Dose Less Than 22 Hours Later|Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||days|||Number
108040|NCT00751400|Secondary|Dosing Occasions With One and More Than One Tablet Taken|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||dosing occasions|||Number
108041|NCT00751400|Primary|Use Days With One or More Misuse Occasions|Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days||days|||Number
108042|NCT00751296|Secondary|Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).|Assess the time to disease progression and overall survival. (Progressive disease is defined as at least one of the following: more than or equal to 50% increase in the sum of the products of the greatest diameters of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥ 2 cm) or new palpable lymph nodes, more than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the costal margin or appearance of palpable hepatomegaly or splenomegaly not previously present, more than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5.0 x109/L, OR transformation to a more aggressive histology (e.g. Richter’s syndrome or prolymphocytic leukemia with >55% prolymphocytes)).|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.|||percentage of participants||95% Confidence Interval|Number
108043|NCT00751296|Primary|To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)|"The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines.~Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with <30% lymphocytes.~Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets > 100 x109/L or 50% improvement over baseline, hemoglobin > 110 g/L or 50% improvement over baseline (without transfusion)."|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.|Severe toxicities were seen in the first two patients enrolled on the initial protocol. The study was halted and the protocol amended to use a starting dose of lenalidomide 2.5 mg with monthly escalations to a target dose of 10 mg, extended tumor lysis prophylaxis and monitoring. 25 response evaluable patients were enrolled on the amended protocol.||participants|||Number
108044|NCT00751179|Secondary|Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.|Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)|Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.||Minutes||95% Confidence Interval|Geometric Mean
108065|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.||percentage of participants|||Number
108529|NCT00745823|Secondary|Mean Change From Baseline to Week 96 in CD4 Cell Count|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Baseline and Week 96|The Week 96 data analysis was not performed.|||||
108045|NCT00751179|Secondary|Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)|Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.||Minutes||95% Confidence Interval|Geometric Mean
108046|NCT00751179|Secondary|Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups|"Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered pretreatment events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure)."|Up to 7 days post dose|Participants who received sugammadex or succinylcholine.||participants|||Number
108047|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.||mmol/L||Standard Deviation|Mean
108048|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.||mmol/L||Standard Deviation|Mean
108049|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.||mmol/L||Standard Deviation|Mean
108050|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.||mmol/L||Standard Deviation|Mean
108051|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.||mmol/L||Standard Deviation|Mean
108052|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.||mmol/L||Standard Deviation|Mean
126211|NCT00587223|Secondary|Rate of Complete Wound Closure Over Time||through 12 weeks|no analysis performed as only 1 subject enrolled||change in area from baseline to Week 12|||Number
108053|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.||mmol/L||Standard Deviation|Mean
108054|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.||mmol/L||Standard Deviation|Mean
108055|NCT00751140|Secondary|Surgical Outcomes: Mean Lymph Node Count|The mean (range) total lymph node count and lymph node count per procedure category. Between 2009 and 2011, patients with suspected upper urinary tract urothelial carcinoma (UUT-UC) underwent open, laparoscopic, or robot-assisted radical nephroureterectomy (RNU) with modified retroperitoneal lymph node dissection (RPLND).|2 years|Total Participants and Participants Per Procedure Category||Lymph Nodes||Full Range|Mean
108056|NCT00751140|Primary|Number of Participants With Pathologically Proven Lymph Node Metastasis|"The number of participants having pathologically proven lymph node metastasis at the time of radical nephroureterectomy (RNU) and modified retroperitoneal lymph node dissection (RPLND).~The primary endpoint is the detection via lymph node dissection of pathological node positive urothelial carcinoma in patients treated with open or laparoscopic nephroureterectomy for upper tract urothelial cancer."|Up to 4 years|All evaluable participants. On histopathological review, one patient had a benign angioma and was excluded from the final data analysis.||participants|||Number
108057|NCT00751114|Secondary|Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)||participants|||Number
108058|NCT00751114|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)||participants|||Number
108059|NCT00751114|Secondary|Change in Body Weight From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."||kg||Standard Error|Least Squares Mean
108060|NCT00751114|Secondary|Lipid Profile: Change From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."||mg/dL||Standard Error|Least Squares Mean
108061|NCT00751114|Secondary|Insulin Dose in the Insulin Glargine Group|Daily dose at the face-to-face visits.|visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value|The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product.||unit per kg body weight||Standard Deviation|Mean
108062|NCT00751114|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline."|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."||mg/dL||Standard Error|Least Squares Mean
108063|NCT00751114|Secondary|Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Study endpoint was defined as the last available SMFPG mean value collected on-treatment.~Change= study endpoint - baseline"|baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."||mg/dL||Standard Error|Least Squares Mean
108064|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.||percentage of participants|||Number
108066|NCT00751114|Primary|HbA1c: Change From Baseline to Study Endpoint|Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value."||percent||Standard Error|Least Squares Mean
108067|NCT00751036|Secondary|Overall Survival (OS)|. OS is defined as the time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff. The median time to overall survival and its associated 95 % CI will be derived, for each treatment arm, using the time to event analysis based on Kaplan-Meier methodology.|time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||Days||95% Confidence Interval|Median
108068|NCT00751036|Secondary|Time to Treatment Failure|TTF, defined as the time from date of randomization to the earliest of date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than ‘Protocol deviation’ or ‘Administrative problems’.|Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||Days||95% Confidence Interval|Median
108069|NCT00751036|Secondary|Disease Control Rate (DCR)|The Disease Control Rate (Complete Response(CR), Partial Response (PD) and Stable Disease (SD) rates for each treatment arm will be computed using the exact Clopper-Pearson interval estimation methodology. DCR is defined as the percentage of patients with a best overall response of • CR, i.e. at least two determinations of CR at least 4 weeks apart without loss of response between the determinations, • PR, i.e. at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) and without loss of PR between the determinations, or • SD lasting at least 24 weeks, i.e. at least one SD or better response at least 24 weeks after randomization (and not qualifying for CR or PR).|every 2 months until 24 months (end of study)|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.||Percentage of Patients||95% Confidence Interval|Number
108070|NCT00751036|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|24 months|Full Analysis Set (FAS) consisted of all randomized patients. Following the intent to treat principle, patients were analyzed according to the treatment which they were assigned at randomization.||Days||95% Confidence Interval|Median
108071|NCT00750919|Primary|Number of Participants Discontinuing Due to AEs|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 26 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Participants|||Number
108072|NCT00750919|Primary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 30 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Participants|||Number
108073|NCT00750919|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded for sleep diary question 5 how much time were you awake, after falling asleep initially as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Minutes per night||Standard Deviation|Mean
108074|NCT00750919|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded for sleep diary question 3 how long did it take you to fall asleep’,  as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Minutes per night||Standard Deviation|Mean
108087|NCT00750880|Primary|Percentage of Participants With Adverse Events (AEs): Overall Summary|Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.|Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants included in the study who received at least 1 dose of study medication and who had at least 1 postbaseline assessment of safety (post-baseline laboratory data, vital signs, or adverse events). number (n) equals (=) number of participants analyzed for the parameter within the specific population.||percentage of participants|||Number
108075|NCT00750919|Primary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded for sleep diary question 6 how much time did you actually spend sleeping as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.||Minutes per night||Standard Deviation|Mean
108076|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
108077|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
108078|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
108079|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
108080|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
108081|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||Subjects|||Number
108082|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
108083|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
108084|NCT00750893|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.|During the 8 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.||subjects|||Number
108085|NCT00750880|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit|FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
108086|NCT00750880|Secondary|Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit|The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
110266|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108088|NCT00750880|Secondary|Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
108089|NCT00750880|Secondary|HAQ-DI Scores by Visit|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
108090|NCT00750880|Secondary|Erythrocyte Sedimentation Rate by Visit|ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
108091|NCT00750880|Secondary|C-Reactive Protein by Visit|The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
108092|NCT00750880|Secondary|Patient's Global Assessment of Pain by Visit|The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as “no pain” and the right-hand extreme=100 mm as “unbearable pain”. The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
108093|NCT00750880|Secondary|Physician's Global Assessment of Disease Activity by Visit|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as “maximum disease activity” (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
108094|NCT00750880|Secondary|Patient's Global Assessment of Disease Activity by Visit|The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as “maximum disease activity” (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
108095|NCT00750880|Secondary|Tender Joint Count by Visit|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the last observation carried forward (LOCF) approach.||tender joints||Standard Deviation|Mean
108096|NCT00750880|Secondary|Swollen Joint Count by Visit|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the LOCF approach.||swollen joints||Standard Deviation|Mean
108097|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.|Weeks 4, 8, 12, 16, 20, and 24|ITT population; only participants with a response (ACR20/ACR50/ACR70/ACR90) were included in the analysis. n=number of participants with a response for the specified parameter||days||95% Confidence Interval|Median
108098|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).|Weeks 4, 8, 12, 16, 20, and 24|ITT population||participants|||Number
108099|NCT00750880|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.|Weeks 4, 8, 12, 16, 20, and 24|ITT population||percentage of participants|||Number
108100|NCT00750880|Secondary|DAS28 Scores by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
108101|NCT00750880|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.|Weeks 4, 8, 12, 16, 20, and 24|ITT population||percentage of participants|||Number
108102|NCT00750880|Secondary|Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event|The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 <2.6.|Baseline,Weeks 4, 8, 12, 16, 20, and 24|ITT population with DAS28 ≤3.2||days||Full Range|Median
108103|NCT00750880|Secondary|Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 <2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; Only population with complete DAS28 data were analyzed.||participants|||Number
108104|NCT00750880|Secondary|Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (<)2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; no imputation of missing data was performed for this analysis.||percentage of participants|||Number
108105|NCT00750867|Secondary|Preliminary Efficacy of IVIg for Treatment of MSA.|The secondary outcome measure was to evaluate the preliminary efficacy of IVIG for the treatment of MSA. The primary efficacy endpoint was change of the Unified MSA Rating Scale (UMSARS-I and UMSAR-II) compared to baseline. UMSARS-I and UMSARS-II are validated semiquantitative rating scales for evaluation of severity of MSA. UMSARS-I comprises a historical review of disease-related impairments and UMSARS-II comprises motor examination. UMSARS-I has 12 questions, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-I is 0 to 48. UMSARS-II has 12 items rated by an examiner, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-II is 0 to 56. The scores of UMSARS-I and UMSARS-II at baseline (month 1) was compared with the scores obtained at the final visit (month 8) which was 8 months apart. The interventions occured at months 2-7, total six times.|Monthly, up to 8 months (including the screening visit and the final visit)|||units on a scale||Standard Deviation|Mean
108106|NCT00750867|Primary|Number of Adverse Events up to Six Months Post-treatment|The primary outcome measure was to evaluate the safety and tolerability of the IVIG infusions in patients with multiple system atrophy. The primary endpoint was defined as the frequency of adverse events (AE). AEs including their severity and relationship to the IVIG were assessed throughout the study and at least 60 days after the last infusion. The AEs were considered to be related to the IVIG infusion (infusional AE) if they occurred during an infusion or within 72 hours afterwards. Non-infusional AEs were further classified as possible related to IVIG or likely not related to IVIG. Serious AEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization. Any AE was defined as occurrence of any symptom regardless of intensity grade.|Monthly, up to 8 months (including the screening visit and the final visit)|Two participants dropped out from the study.||Adverse events|||Number
108107|NCT00750815|Secondary|Phase II: Two Year Overall Survival (OS)|Overall survival by disease risk stratification after CVDD. OS: time from initiation of therapy until death from any cause.|2 years|Participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification.||percentage of participants||95% Confidence Interval|Number
108530|NCT00745823|Secondary|Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.|||||
108108|NCT00750815|Secondary|Phase II: Progression-Free Survival (PFS)|"Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes.~Progressive Disease (PD): Progressive Disease requires any one or more of the following:~Increase of ≥ 25% from baseline in:~serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL)~urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)"|Up to 50.9 months|||months||95% Confidence Interval|Median
108109|NCT00750815|Primary|Phase II: Overall Response Rate (ORR)|Best response to CVDD chemotherapy. Overall Response: Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR). PR: ≥ 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein with urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.|Up to 6 months|All Participants with Partial Response, Very Good Partial Response, or Complete Response.||participants|||Number
108110|NCT00750815|Primary|Phase I - Maximum Planned Dose (MPD) Level|"Maximum Phase II planned dose of cyclophosphamide when given in combination with bortezomib, pegylated liposomal doxorubicin and Dexamethasone (CVDD) in participants with newly diagnosed active multiple myeloma. Dose levels 1, 2, 3, 4 as outlined in Treatment Arm A.~If no dose limiting toxicity (DLT) was reported in the first 3 participants at a dose level, that dose level was to be considered safe and 3 participants would be enrolled at the next dose level. If 1/3 participants in a cohort at a dose level had dose limiting toxicity (DLT), the dose level would be expanded to obtain 6 evaluable participants. MPD reflects the highest dose of drug that did not cause a DLT in 33% of participants."|9 months|All participants in Arm A. Three participants at each dose level.||Dosing Level|||Number
108111|NCT00750737|Secondary|Efficacy Outcome Measured as Success or Failure|Success: Defined as the absence of proven or probable invasive fungal infection through the end of prophylaxis and absence of Grade 1-4 toxicity related to prophylaxis requiring the discontinuation of the drug. Failure: Presence of proven or probable fungal infection or development of Grade 1-4 toxicity related to prophylaxis while on study drug and requiring discontinuation of study drug or inability to tolerate intravenous ABLC (due to infusion related toxicities) or oral Posaconazole (due to mucositis or vomiting).|Day 1 through Day 42|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.||percentage of participants|||Number
108112|NCT00750737|Primary|Incidence of Invasive Fungal Infection (IFI)|Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).|Within 7 days of antifungal prophylaxis therapy|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.||percentage of participants|||Number
108113|NCT00750373|Secondary|Readmission Due to Development of Congestive Heart Failure||up to 6 months after enrollment||||||
108114|NCT00750373|Secondary|All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies||up to 6 months after enrollment||||||
108115|NCT00750373|Secondary|Recurrences of Infective Endocarditis||up to 6 months after enrollment||||||
108116|NCT00750373|Secondary|All-cause Death||up to 6 month after enrollment||||||
108117|NCT00750373|Primary|Number of Participants With In-hospital Death or Clinical Embolic Events|The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.|within 6 weeks from the randomization|intention to treat analysis||participants|||Number
108118|NCT00750360|Secondary|Number of Participants Reporting Serious Adverse Events (SAE).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Within 1 month following vaccination|||participants|||Number
108119|NCT00750360|Secondary|Number of Participant Reporting Unsolicited Adverse Events.|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day follow-up period (Day 0 to Day 20) after vaccination|||participants|||Number
108120|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.|||participants|||Number
108121|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.|||participants|||Number
108122|NCT00750360|Primary|Number of Participants Reporting Severe Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities"|During the 21-day follow-up period (Day 0 to Day 20) after vaccination|||participants|||Number
108123|NCT00750308|Primary|Insulin Sensitivity|As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm|three weeks|Those who completed protocol||(mU/L)-1x(min)-1xL||Standard Error|Mean
108124|NCT00750308|Primary|Beta Cell Function|Beta cell function as measured during a frequently sampled IV glucose tolerance test|3 hours|||microU/mM||Standard Error|Mean
108179|NCT00749775|Secondary|Change in Diastolic Blood Pressure Over Time.|The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).||mmHg||Standard Deviation|Mean
110267|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108125|NCT00750282|Secondary|Standard Uptake Value Ratios for Florbetaben Signal|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.)|90-110 min post injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||ratio||Standard Deviation|Mean
108126|NCT00750282|Secondary|Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)|The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement.|45-60 min, 90-110 min, 110-130 min|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||Kappa coefficient|||Number
108127|NCT00750282|Secondary|Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment|PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed|45 - 60 min and 110 - 130 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||percentage of subjects||95% Confidence Interval|Number
108128|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.|"Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores “2 or 3”) which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score “1) which was considered a match for specificity.~The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia.~Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media."|90 - 110 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis||percentage of subjects||95% Confidence Interval|Number
108129|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth|"Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis.~Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used.~Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of “1” (without beta-amyloid plaque load) or “2” (with minor beta-amyloid plaque load) was considered normal and a BAPL score of “3” (with significant beta-amyloid plaque load) was considered abnormal.~Using algorithm B (Average), a brain scan of a subject with a BAPL score of “1” was considered normal and a brain scan with a BAPL score of “2” or “3” was considered abnormal. Algorithm B was used in Part B and in the final"|90 - 110 min after investigational medical product (IMP) injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis.(n=146)||percentage of subjects||95% Confidence Interval|Number
108130|NCT00750191|Other Pre-specified|Opioid Usage|Patient reported Opioid usage (converted to morphine equivalents)|6 months|||mg||Standard Deviation|Mean
108131|NCT00750191|Secondary|Disability|Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)|6 months|||units on a scale||Standard Deviation|Mean
108132|NCT00750191|Secondary|Pain|Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)|6 months|||units on a scale||Standard Deviation|Mean
108133|NCT00750191|Primary|Physical Function|"Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component.~Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome)."|6 months|||units on a scale||Standard Deviation|Mean
108134|NCT00750152|Secondary|Mycological Cure and Treatment Effectiveness|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.|Week 4 (two weeks post-treatment)|This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.||percentage of subjects|||Number
108135|NCT00750152|Primary|Percentage of Subjects|Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.|Week 4 post-baseline|The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment.||percentage of subjects with complete cur|||Number
108136|NCT00750139|Secondary|Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.|Week 6|This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment.||percentage of Subjects|||Number
108137|NCT00750139|Primary|Percentage of Subjects With Complete Cure at Week 6.|"The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6.~The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6.~Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale."|Week 6|This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment.||percentage of subjects with complete cur|||Number
108138|NCT00750061|Secondary|Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain|Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)|6 months|Full Analysis Set||units on a scale||Standard Deviation|Mean
108139|NCT00750061|Primary|Changes of Neurological Scores for Baseline|Changes of Motor Scores (0 ~ 100), Pin Prick Scores (0 ~ 112) and Light Touch Scores (0 ~ 112) from Baseline to Week 6 and Month 6. The higher the changes the better the functional improvement.|6 months|Full Analysis Set||units on a scale||Standard Deviation|Mean
108140|NCT00749996|Secondary|To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).|"The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI).~The ODI is a low back pain disability questionnaire used to measure a patient’s permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability."|12 Months|||patient's score||Standard Deviation|Mean
108141|NCT00749996|Primary|To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).|The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning ‘no pain’ and 10cm meaning ‘worst possible pain’) will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.|6 Months|||units on a scale||Standard Deviation|Mean
108142|NCT00749957|Secondary|Participants With Changes in Best Corrected Visual Acuity|Increase in BCVA of 7 or more letters at Year 2 visit compared to average baseline value|2 years|||participants|||Number
108143|NCT00749957|Secondary|Participants With Changes in Visual Fields|Improvement in the central 30 degree visual field, measured by static perimetry, at one or more time points after treatment, that was greater than the limit of agreement for baseline values .|2 years|||participants|||Number
108144|NCT00749957|Primary|Number of Participants Experiencing Ocular or Non-ocular Adverse Events||2 years|||participants|||Number
108145|NCT00749944|Secondary|Change From Baseline in the Number of Cigarettes Smoked Per Day||Baseline (Week 0) to Week 2|FAS; (n)=number of subjects with at least 1 dose of study drug and an observation for a given day.||cigarettes smoked per day||Standard Deviation|Mean
108146|NCT00749944|Secondary|Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation)|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (during treatment) in the previous 7 days and who did not have carbon monoxide of more than 10 parts per million for that observation (if measured).|Week 5 to Week 13|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108147|NCT00749944|Secondary|Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory, which was used to collect the information of cigarette or other nicotine use during the study) and who did not have carbon monoxide of more than 10 parts per million at any time from Week 9 to Week 12|Week 9 to Week 12|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108148|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score|SDAS total scores ranged from 0 (not present) to 44 (extremely severe). Participants exceeding the threshold had a SDAS total score of more than 6 out of 44.|Baseline B (Week 2) to Week 4 (Period BC)|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108149|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Total score ranged from 30 (less impulsive) to 120 (more impulsive). Participants exceeding the threshold had a BIS-11 total score more than or equal to 70 out of 120. BIS-11 total scores of more than or equal to 70 could reflect clinically important and potentially pathological impulsivity.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108150|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Suicidality total score ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency). No threshold criterion was determined for OAS-m Suicidality total score.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|The number of participants above the threshold for the OAS-m Suicidality total score was not analyzed as the majority of observations were recorded as 0.||participants|||Number
126212|NCT00587223|Secondary|Time Until Complete Closure||through 12 weeks|no analysis performed as only 1 subject enrolled||days|||Number
108151|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Irritability total score ranged from 0 (no irritability) to 10 (extreme irritability). Participants exceeding the threshold had an OAS-m Irritability total score of more than or equal to 2 out of 10. OAS-m Irritability total scores of more than or equal to 2 reflect clinically important irritability.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108152|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Aggression total score ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week. Participants exceeding the threshold had an OAS-m Aggression total score of more than or equal to 3 out of any number with no upper limit depending on the frequency of agressive behaviour in a week. OAS-m Aggression total scores of more than or equal to 3 reflect clinically important aggression.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108153|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms. Total scores ranged from 0 (not affected) to 56 (very severely affected). Participants exceeding the threshold had a HAM-A total score of more than or equal to 14 out of 56. HAM-A total scores of more than or equal to 14 may reflect clinically noteworthy levels of anxiety.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108154|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms. Total score ranged from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Participants exceeding the threshold had a MADRS total score of more than 14 out of 60. MADRS total scores exceeding 14 may represent clinically notable effective symptomatology.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively. Statistical analyses were not performed for Period AB due to the small number of participants exceeding the threshold.||participants|||Number
108155|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score|POMS total mood disturbance (TMD) summary results were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). Participants exceeding the threshold had an increase from baseline of 1 standard deviation of the TMD baseline T-score plus 1 or more.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||participants|||Number
108156|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale|The MNWS increased appetite subscale contains 1 item (increased appetite) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no increased appetite) to 4 (extreme increased appetite).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108157|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale|The MNWS restlessness subscale contains 1 item (restlessness) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no restlessness) to 4 (extreme restlessness).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108158|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale|The MNWS urge to smoke subscale contains 1 item (urge to smoke) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no urge to smoke) to 4 (extreme urge to smoke).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108159|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale|The MNWS insomnia domain subscale contains 2 items (difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average of the 2 items and ranged from 0 (no insomnia) to 4 (extreme insomnia).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108218|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)||percentage of participants|||Number
108160|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale|The MNWS negative affect domain subscale contains 4 items (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average from all 4 items and ranged from 0 (no negative affect) to 4 (extreme negative affect).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108161|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score|The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Total scores were the average score for all 9 items and ranged from 0 (no withdrawal symptoms) to 4 (extreme withdrawal symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108162|NCT00749944|Primary|Change From Baseline in the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is a 30-item self-report questionnaire designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Possible responses to each item were: 1=rarely/never, 2=occasionally, 3=often, and 4=almost always/always. Scores of Items 1, 7, 8, 9, 10, 12, 13, 15, 20, 29 and 30 were reversed when calculating the total score. Total score ranged from 30 (less impulsive) to 120 (more impulsive).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108163|NCT00749944|Primary|Change From Baseline in the Social Dysfunction and Aggression Scale (SDAS): Total Score|The SDAS contains 11 items with 5 possible responses: 0=not present, 1=doubtful or very mild, 2=mild to moderate, 3=severe, and 4=extremely severe. The SDAS was collected 3 times a day during the inpatient abstinence period (BC). Total scores ranged from 0 (not present) to 44 (extremely severe).|Baseline B (Week 2) to Week 4 (Period BC)|No change from baseline analysis was performed on the SDAS total score as the majority of observations were recorded as 0.||scores on a scale||Standard Error|Least Squares Mean
108164|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Suicidality total score was calculated by summing the items Q7 to 7b. Scores for Q7 ranged from 0 (none) to 6 (very extreme) and scores for Q7a to 7b ranged from 0 (none) to 5 (extreme). Total scores ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|No change from baseline analysis was performed on the OAS-m Suicidality total score as the majority of observations were recorded as 0.||scores on a scale||Standard Error|Least Squares Mean
108165|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Irritability total score was calculated by summing the items in Q5 to 6. Scores for each question ranged from 0 (not at all) to 5 (extreme). Total scores ranged from 0 (no irritability) to 10 (extreme irritability).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108166|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Aggression total score was calculated by summing the weighted scores in Q1 to 4. Scores for each question ranged from 0 (no events) to 5 (very severe events). Total scores ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108167|NCT00749944|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms and is a 14-item questionnaire. Each item was scored from 0 (not present) to 4 (very severe) and a lower score indicated less affected. Total scores ranged from 0 (not affected) to 56 (very severely affected).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108168|NCT00749944|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms and is a 10-item checklist. Each item was rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108531|NCT00745823|Secondary|Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.|||||
108169|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale|POMS Confusion subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Efficient. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108170|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale|POMS Fatigue subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108171|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale|POMS Vigor subscale data were responses to 8 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108172|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale|POMS Anger-Hostility subscale data were responses to 12 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108173|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale|POMS Depression-Dejection subscale data responses to 15 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108174|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale|POMS Tension-Anxiety subscale data were responses to 9 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Relaxed. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108175|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD)|POMS TMD were responses to 65 items in 6 subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor, Fatigue, and Confusion), on ‘How you feel right now?’ (scale:0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for Relaxed and Efficient in the Tension-Anxiety and Confusion subscales. TMD was the sum of the scores of all 6 subscales but weighting Vigor negatively. Summary results (TMD scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|Full analysis set (FAS): All randomized subjects with at least 1 dose of study drug and at least 1 post-baseline neuropsychiatric evaluation or Minnesota Nicotine Withdrawal Scale (MNWS) obtained; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.||scores on a scale||Standard Error|Least Squares Mean
108176|NCT00749931|Post-Hoc|Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens||Up to 2 months post-surgery|||percentage of participants|||Number
108177|NCT00749931|Primary|The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.|Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively|two weeks after surgery|"The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen (PSS – Positive specimen subjects)"||percentage of participants analyzed|||Number
108178|NCT00749775|Secondary|Number of Participants That Responded to Selara Treatment.|Number of participants among the efficacy analysis population that responded to Selara treatment.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).||participants|||Number
108551|NCT00744328|Secondary|Infant Serum Concentrations of Estradiol in 3 Treatment Arms||monthly||||||
157107|NCT00318591|Secondary|Number of Participants With One or More Urinary Tract Infection||4-6 months|||participants|||Number
108180|NCT00749775|Secondary|Change in Systolic Blood Pressure Over Time.|The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).||mmHg||Standard Deviation|Mean
108181|NCT00749775|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|12 weeks|No statistical analysis provided for the frequency of serious treatment related adverse events.||participants|||Number
108182|NCT00749775|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.|12 weeks|No statistical analysis provided for the frequency of Treatment Related adverse events.||participants|||Number
108183|NCT00749684|Primary|Relapse Free Survival Time|Median time to recurrence according to Kaplan Maier evaluation|Throughout 12 months of treatment and 24 months of follow-up|||months||Full Range|Median
108184|NCT00749684|Primary|Number of Participants With Disease Recurrence|Number of participants with disease recurrence was being measured.|Throughout 12 months of treatment and 24 months of follow-up|138 participants with malignant melanoma, 88 male participants and 50 female participants were evaluated.||participants|||Number
108185|NCT00749671|Secondary|Patient Recall of Defibrillation Testing|The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.|30 minutes|||percentage of patients with DFT recall|||Number
108186|NCT00749671|Primary|Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes|"Sedation level was evaluated and graded according to the observer's assessment of alertness/sedation (OAAS) rating scale. This scale has 6 possible measures of consciousness:~OAAS score 5—awake and responds readily to name spoken in normal tone.~OAAS score 4—lethargic responses to name in normal tone.~OAAS score 3—responds only after name is called loudly and/or repeatedly.~OAAS score 2—responds only after name called loudly and mild shaking.~OAAS score 1—does not respond when name is called loudly and mild shaking or prodding.~OAAS score 0—does not respond to noxious stimulation."|30 minutes|||units on a scale||95% Confidence Interval|Mean
108187|NCT00749580|Secondary|Virologic Suppression of < 75 Copies/ml at 48 Weeks||at 48 weeks for each patient|||participants|||Number
108188|NCT00749580|Primary|Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen|Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.|at 24weeks for each patient|||participants|||Number
108189|NCT00749476|Primary|Number of Participants Reporting Efficacy|Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.|4 months|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||Participants|||Number
108190|NCT00749463|Secondary|Point Prevalence Smoking Abstinence (PPSA)|Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.|24 Weeks|||Participants|||Number
108191|NCT00749463|Primary|Smoking Abstinence|Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day|24 Weeks|||Participants|||Number
108192|NCT00749463|Secondary|Smoking Consumption Per Week|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)|24 Weeks from last visit:|||Cigarettes||Standard Deviation|Mean
108193|NCT00749463|Secondary|Smoking Consumption Per Day|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)|24 Weeks from last visit:|||Cigarettes||Standard Deviation|Mean
108194|NCT00749463|Secondary|Carbon Monoxide (CO)-Verified Smoking Reduction|Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)|Baseline to Week 24|||Percentage of Participants||Standard Deviation|Mean
108195|NCT00749463|Primary|Self-Reported Smoking Reduction|Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day|24 Weeks|||Percentage of Participants||Standard Deviation|Mean
108196|NCT00749463|Primary|Treatment-Related Adverse Events|Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher|24 Weeks|Safety Analysis Set (ITT)||Percentage of Participants|||Number
108197|NCT00749398|Secondary|Number of Participants With Satisfactory Health Status|"Participant's opinion on his/her health status, as assessed by the following question: Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)"|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Participants|||Number
108198|NCT00749398|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108199|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Participant|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108552|NCT00744328|Secondary|Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development||yearly||||||
108200|NCT00749398|Secondary|Static PGA Score as Assessed by the Participant|Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108201|NCT00749398|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108202|NCT00749398|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108203|NCT00749398|Secondary|Percent Body Surface Area (BSA) Involved With Psoriasis||Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)|Per protocol analysis.||Percent BSA Involved with Psoriasis||Standard Deviation|Mean
108204|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Investigator|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108205|NCT00749398|Primary|Dynamic Photographic PGA Score as Assessed by Two Dermatologists|The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108206|NCT00749398|Secondary|Static PGA Score as Assessed by the Investigator|Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108207|NCT00749398|Primary|Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists|Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.||Score on a scale||Standard Deviation|Mean
108208|NCT00749268|Secondary|Hernia Recurrence||Discharge, 1 Month, 6 Month, 1 year|||participants|||Number
108209|NCT00749268|Secondary|Quality of Life|"Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.~The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Pre-op, Month 1, Month 6, 1 year|Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.||units on a scale||Standard Deviation|Mean
108210|NCT00749268|Primary|Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events||One year|||participants|||Number
108211|NCT00749268|Primary|Postoperative Pain|"Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.~Scale is 0 - 10 with 0 being no pain and 10 being worst pain imaginable."|Discharge, Month 1, Month 6, Month 12|1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.||units on a scale||Standard Deviation|Mean
108212|NCT00749190|Secondary|Trough Concentrations of Empagliflozin in Plasma|(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
108213|NCT00749190|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||kg||Standard Error|Mean
108214|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU / mmol||Standard Error|Mean
108215|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)||mU/L x mmol/L||Standard Error|Mean
108216|NCT00749190|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA|Baseline and 12 weeks|FAS (CLOCF)||mU/L||Standard Error|Mean
108217|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)||percentage of participants|||Number
108220|NCT00749190|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|FAS using modified LOCF imputation method||mg/dL||Standard Error|Mean
108221|NCT00749190|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment|"Change from baseline in HbA1c after 12 weeks of treatment.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).||percentage of HbA1c||Standard Error|Mean
108222|NCT00749073|Primary|Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.|The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Six months|All available treated patients with six month follow-up.||units on a scale||95% Confidence Interval|Mean
108223|NCT00749073|Primary|Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire|Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.|Baseline and Month 6|All treated patients having six month follow-up were included.||units on a scale||Standard Deviation|Mean
108224|NCT00749073|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported.||units on a scale||Standard Deviation|Mean
108225|NCT00748982|Secondary|QTcF Interval|Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula|Up to 24 hours following start of IV dosing.|||ms||95% Confidence Interval|Mean
108226|NCT00748982|Secondary|Area Under Curve (AUC) ( µmol*h/L) of AZD1305|To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.|||µmol*h/L||Full Range|Mean
108227|NCT00748982|Secondary|Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group|To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.|From randomisation to last study visit (mean infusion time 1.6 hours)|||Participants|||Number
108228|NCT00748982|Primary|Left Ventricular Ejection Fraction (LVEF), Change From Baseline|To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out|||Percent change||95% Confidence Interval|Mean
108229|NCT00748969|Secondary|Change in Neuropsychological Functioning and Brain Volumetrics.||12 months||||||
108230|NCT00748969|Secondary|Change in Muscle Strength Measured by Biodex and Hand Grip Dynamometer.||12 months||||||
108231|NCT00748969|Secondary|Change in Mobility Measured by Force and Gait Measurements.||12 months||||||
108232|NCT00748969|Secondary|Change in Bone Mineral Density, Content, and Strength by DXA and pQCT, and Change in Serum Markers of Bone Metabolism.||12 months||||||
108233|NCT00748969|Secondary|Safety of Nutropin AQ® in Children With MPS I, II, and VI. Safety Endpoints Are: • Physical Examinations • Fundoscopic Examinations • Adverse Events • Radiographic Examinations of Spine and Lower Extremities|"Three days after starting treatment with Nutropin AQ the subjects mother reported that the study subject developed headache, increased noisy and more labored breathing (history of obstructive sleep apnea treated with BIPAP), and fatigue with watery eyes. Symptoms resolved with discontinuation of Nutropin AQ and before evaluation by physician. Subject withdrew from the study due to these adverse effects."|1 months||||||
108234|NCT00748969|Primary|Change in Growth Velocity From Baseline to End of Study Year 1.||12 months|"Zero participants analyzed in the No growth hormone treatment group due to subject withdrew from study as soon as informed they were assigned the no treatment group."||cm/yr|||Number
108235|NCT00746512|Secondary|Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])|"The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was:~DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96.~Where SQR is square root and ln is natural log.~The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission."|Baseline and Day 14|||score on scale||Standard Deviation|Mean
108236|NCT00746512|Primary|Synovial Blood Flow|Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.|Baseline and Day 14|||pixel count||Standard Deviation|Mean
108237|NCT00746421|Secondary|Brief Assessment of Cognition for Affective Disorders (BAC-A)|This is a series of neurocognitive tests and includes brief assessments of attention, motor speed, working memory, verbal memory, reasoning and problem solving, verbal fluency, affective interference, and emotion inhibition. The total BAC-A score is represented by a composite T-score which is dimensionless. This is computed by adding up the scores for each trial of a test domain (e.g. verbal memory) within the cognitive battery. Each test domain total is then inputted into a proprietary BAC-A calculator which determines the composite T-scores. A higher score indicates better performance. A study of 404 healthy adults demonstrated a mean composite score of 50 with a standard deviation of 10 (Keefe et al. Schizophrenia Bulletin. 2008; 102: 108-115).|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.||units on a scale (composite t-score)||Standard Deviation|Mean
108238|NCT00746421|Primary|The Continuous Performance Test-Identical Pairs Version|The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials.|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.||units on a scale||Standard Deviation|Mean
108239|NCT00748865|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,|once upon instillation|||Units on a scale||Standard Deviation|Median
108240|NCT00748826|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised of a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participant|||Number
108241|NCT00748826|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the In-vitro TB test (cellular blood test, i.e. gamma interferon release assays) per clinical testing as the first screening test was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participants|||Number
108242|NCT00748826|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (Multiple puncture Tuberculin skin test) per clinical testing as the first screening test was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participants|||Number
108243|NCT00748826|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (Tuberculin sensitivity skin test by intradermal injection) per clinical testing as the first screening test was presented in~three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.||participants|||Number
108244|NCT00748709|Secondary|Number of Patients With Diarrhea or Rash|Number of Patients with Diarrhea or Rash|First administration of trial medication until 28 days after last administration of trial medication|TS||Participants|||Number
108245|NCT00748709|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.|Day 15|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
108246|NCT00748709|Primary|Percentage of Participants With Objective Response (OR)|OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.||percentage of patients|||Number
108247|NCT00748709|Secondary|Maximum CTCAE Grade|Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade|First administration of trial medication until 28 days after last administration of trial medication|TS||Participants|||Number
108249|NCT00748709|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for PFS.|||||
108250|NCT00748709|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for duration of OR.|||||
108251|NCT00748709|Secondary|Time to Objective Response (OR)|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|Trial terminated early, therefore no data summaries produced for time to OR.|||||
108252|NCT00748709|Secondary|Percentage of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|TS.||percentage of patients|||Number
108253|NCT00748657|Secondary|Frequency and Severity of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0||Up to 5 years||||||
108254|NCT00748657|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||Months||95% Confidence Interval|Median
108255|NCT00748657|Secondary|Progression-free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients||Months||95% Confidence Interval|Median
108256|NCT00748657|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients||percentage of patients||90% Confidence Interval|Number
108257|NCT00748579|Secondary|Effects of CK-1827452 on Ventricular Performance, Myocardial Oxygen Consumption, Pressure-volume Relationships, Systolic Ejection Time and Invasively Measured Hemodynamics, Including Filling Pressures and Cardiac Output.||1 day||||||
108258|NCT00748579|Primary|Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.|Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.|1 day|Study was terminated due to poor enrollment; 2 participants completed the study. Data quantity was insufficient to analyze or draw conclusions.|||||
108259|NCT00748566|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior(3)(“Yes” on “preparatory acts or behavior”), suicidal ideation(4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(“Yes” on “Has subject engaged in non-suicidal self-injurious behavior”).|Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
108260|NCT00748566|Secondary|Changes From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
108261|NCT00748566|Secondary|Change From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Index (EQ-I) Score at Week 28 and 52|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
108262|NCT00748566|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52|SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
108585|NCT00745030|Secondary|Changes in Patient Completed Epworth Sleepiness Scale (ESS)||12 weeks||||||
108586|NCT00745030|Secondary|Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale||12 weeks||||||
108263|NCT00748566|Secondary|Change From Baseline in Drug-Attitude Inventory–30-Item Scale (DAI-30) Score at Week 28 and 52|DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
108264|NCT00748566|Secondary|Clinical Global Impression-Improvement (CGI-I) Scale Score|CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.|Endpoint (premature discontinuation or Week 52)|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
108265|NCT00748566|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52|CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
108266|NCT00748566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52|Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||units on a scale||Standard Deviation|Mean
108267|NCT00748566|Secondary|Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate).|Baseline, Week 4, 12, 28, 52|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure. Missing values at Week 52 were imputed using LOCF. N (number of participants analyzed)=participants evaluable for this measure. n=evaluable participants at specified time points.||milliseconds||Standard Deviation|Mean
108268|NCT00748566|Secondary|Change From Baseline in the Physical Activity Index Score at Week 28 and 52|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
108269|NCT00748566|Secondary|Change From Baseline in Insulin Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values were imputed using LOCF at Week 52. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||international unit per liter (IU/L)||Standard Deviation|Mean
108270|NCT00748566|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||percentage of total hemoglobin||Standard Deviation|Mean
108271|NCT00748566|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52|Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||kg/m^2||Standard Deviation|Mean
108272|NCT00748566|Secondary|Change From Baseline in Weight at Week 4,12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||kilogram (kg)||Standard Deviation|Mean
108273|NCT00748566|Secondary|Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mmol/L||Standard Deviation|Mean
108286|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 2 years after implants have been loaded|Population includes subjects who completed 24 month visit.||Percentage of implants|Participants||Number
108587|NCT00745030|Secondary|Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner)||12 weeks||||||
108274|NCT00748566|Secondary|Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.||percent of 10-year CHD risk||Standard Deviation|Mean
108275|NCT00748566|Secondary|Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mg/dL||Standard Deviation|Mean
108276|NCT00748566|Secondary|Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52|Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mg/dL||Standard Deviation|Mean
108277|NCT00748566|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52|BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||mmHg||Standard Deviation|Mean
108278|NCT00748566|Secondary|Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52|Waist circumference data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||cm||Standard Deviation|Mean
108279|NCT00748566|Secondary|Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||percentage of participants||95% Confidence Interval|Number
108280|NCT00748566|Secondary|Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||participants|||Number
108281|NCT00748566|Secondary|Percentage of Participants With Metabolic Syndrome (MS)|According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||percentage of participants||95% Confidence Interval|Number
108282|NCT00748566|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.||risk factors||Standard Deviation|Mean
108283|NCT00748566|Primary|Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)|MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.|Endpoint (premature discontinuation or Week 52)|Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants||95% Confidence Interval|Number
108284|NCT00748241|Secondary|Implant Failure|Total number of implants reported as failure.|3 years after implant placement|Number of failed implants based on total number of patients enrolled and total number of placed implants||Number of implants|Participants||Number
108285|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 3 years after implants have been loaded|Population includes subjects who completed 36 month visit.||Percentage of implants|Participants||Number
108287|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 1 year after implants have been loaded|Population includes subjects who completed 12 month visit.||Percentage of implants|Participants||Number
108288|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 6 months after implants have been loaded|Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).||Percentage of implants|Participants||Number
108289|NCT00748189|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Gram per liter||Standard Deviation|Mean
108290|NCT00748189|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
108291|NCT00748189|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
108292|NCT00748189|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented by treatment cycle. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
108293|NCT00748189|Secondary|Number of Participants With AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
108294|NCT00748189|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population||Participants|||Number
108295|NCT00748189|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL)|HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQC30), Chronic Lymphocytic Leukemia module (EORTC QLQ-CLL16), EuorQoL-Five Dimension (EQ-5D), and HCQ. Period (P)1 (Day 85, Day 169, Day 253) and P2 (scheduled follow-up (FU) and withdrawal visits) analysis were considered. Baseline (BL) for P1 was defined as score from screening visit and BL for P2 was defined as the last on-treatment score. The 2 principal QoL outcomes were pre-specified as the Global Health scale (GHS/QOL) of the EORTC QLQ-C30 and fatigue scale of the EORTC QLQ-CLL16. For EORTC QLQ-C30,GHS/Qol, the possible scale range was 0-100 (with 100 being 'best') and a positive difference from BL is indicative of better functioning (range -100 to +100). For the EORTC QLQ-CLL16 fatigue scale, the possible scale range was 0-100 (with 0 being 'best') and a negative difference from BL represents an improvement in fatigue (range -100 to +100).|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Scores on a scale||Standard Deviation|Mean
108296|NCT00748189|Secondary|Dose-normalized AUC(0-6) and AUC(0-inf) of Chlorambucil and Dose-normalized AUC(0-6) of Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The area under the plasma concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) and over 6 hours (AUC[0-6]) of chlorambucil and AUC(0-6) of PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.||Hours*nanogram/milliliter/milligram||Standard Deviation|Geometric Mean
108297|NCT00748189|Secondary|Dose-normalized Cmax of Chlorambucil and Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The maximum observed concentration (Cmax) of chlorambucil and PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.||nanograms per milliliter per milligram||Standard Deviation|Geometric Mean
108298|NCT00748189|Secondary|Plasma Half Life (t1/2) of Ofatumumab|The terminal half-life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original concentration. Blood samples were collected to assess the plasma half-life of ofatumumab. Blood samples were collected from participants who received ofatumumab plus chlorambucil pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population||hours||Geometric Coefficient of Variation|Geometric Mean
108299|NCT00748189|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Blood samples were collected from participants who received ofatumumab plus chlorambucil at predose and 0.5 hour after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."||Liters||Geometric Coefficient of Variation|Geometric Mean
108300|NCT00748189|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval [AUC(0-tau)] is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the ofatumumab plasma concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of ofatumumab. For estimation of AUC(0-tau), blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hous after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."||µg x hours/mL||Geometric Coefficient of Variation|Geometric Mean
108301|NCT00748189|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population.||Milliliter/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
108302|NCT00748189|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of treatment.|Cycle 1 Day 1,Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, and Cycle 9 Day 1|Pharmacokinetic (PK) Population: all participants for whom a pharmacokinetic sample was obtained and analyzed.||Micrograms/Milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
108303|NCT00748189|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result|Serum samples for analysis of HAHA were collected at Baseline (Screening), Cycle 4 Day 1 (after 3 months of treatment), and at 1 month and 6 months post last dose of ofatumumab. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive and further evaluated in the titration test to obtain a titer of HAHA.|Baseline, Cycle 4 Day 1, 1 Month Follow-up, and 6 Month Follow-up|Safety population: all participants who received at least 1 dose of a study drug. Only participants with post-ofatumumab HAHA Results are included.||Participants|||Number
108343|NCT00748085|Primary|Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events.||1 year|no analysis conducted-study terminated for business reasons|||||
108304|NCT00748189|Secondary|Number of Participants With Improvement in Constitutional Symptoms (CS)|Assessment for the presence of the following symptoms were performed at Screening, Day 1 of each treatment cycle and at every Follow-up visit: night sweats (without signs of infection); unexplained, unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of greater than 38 degrees celsius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue. The best response refers to overall best response in terms of CR, CRi, PR or nPR. Data are presented for constitutional response= yes and no.|Baseline, Cycle 3 Day 1, and 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
108305|NCT00748189|Secondary|Number of Participants With Improvement in ECOG Performance Status of 0 or 1, as Assessed by the IRC|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. Participants with an ECOG performance status of 0 or 1 are shown..|Baseline, Cycle 3 Day 1, 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
108306|NCT00748189|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Months||95% Confidence Interval|Median
108307|NCT00748189|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Months||95% Confidence Interval|Median
108308|NCT00748189|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.||Months||95% Confidence Interval|Median
108309|NCT00748189|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (CR, CRi, nPR, or PR). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders. Only responders (CR, CRi, PR, nPR) were included in the analysis.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Time to response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.||Months||95% Confidence Interval|Median
108310|NCT00748189|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the total IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Months||95% Confidence Interval|Median
108311|NCT00748189|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD)|MRD was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.||Participants|||Number
108312|NCT00748189|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. OR was according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.||Participants|||Number
108313|NCT00748189|Primary|Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|Intent-to-Treat (ITT) Population: all par. randomized to study treatment regardless of whether or not they received treatment. PFS was assessed by a blinded independent review committee according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines.||Months||95% Confidence Interval|Median
108314|NCT00748098|Secondary|Number of Participants Who Self-reported “Very Satisfied” or “Satisfied” With the Investigational Product at Week 4/10 Using LOCF|"Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study. The participant responses ranged from 1 (Very satisfied) to 7 (Very dissatisfied). A satisfied response was scored a 2."|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||participants|||Number
108315|NCT00748098|Secondary|"Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF"|The CGI-I scale allows the investigator to rate the participant’s global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 (“Very much improved”) or 2 (“Much improved”) are considered to be responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||participants|||Number
108316|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness – Severity (CGI-S) Score at Week 4/10 Using LOCF|The CGI-S scale allows the investigator to rate the severity of participants’ illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
108317|NCT00748098|Secondary|Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF|"Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant’s subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: “Helped me sleep,” Helped me fall asleep faster,” “Helped me sleep longer,” and “Helped me get a better night’s sleep.”"|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||participants|||Number
108318|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
108344|NCT00748072|Primary|The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.||Immediately post-biopsy and 24 hours post-biopsy.|||participants|||Number
108345|NCT00746395|Secondary|Small Bowel Transit|Small bowel transit time|Duration of the test - 8 hours|Patients without transit to cecum were excluded||Minutes||Standard Error|Mean
108319|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.||number of PLMs per hour||Standard Error|Least Squares Mean
108320|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.|Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
108321|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes/hour||Standard Error|Least Squares Mean
108322|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
108323|NCT00748098|Secondary|Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||participants|||Number
108324|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||hours||Standard Error|Least Squares Mean
108325|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF|The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||awakenings||Standard Error|Least Squares Mean
108326|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Participant’s Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.|Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||scores on a scale||Standard Error|Least Squares Mean
108346|NCT00746395|Primary|Complete Small Bowel Transit|Percent of subjects with capsule passage through small bowel|8 hours|Placebo 95%, lubiprostone 75%||percentage of subjects with passage|||Number
108588|NCT00745030|Secondary|Changes in Clinician Global Impression Scale of Improvement (CGI-I)||10 weeks||||||
108327|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF|Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.||scores on a scale||Standard Error|Least Squares Mean
108328|NCT00748098|Secondary|Number of PLMAI Responders at Week 4/10 Using LOCF|PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||participants|||Number
108329|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||number of PLMs/total hours of sleep||Standard Error|Least Squares Mean
108330|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10|Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
108331|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF|In REM sleep, a participant’s breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
108332|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10|Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
108333|NCT00748098|Secondary|Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF|Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
108334|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10|Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
108405|NCT00747344|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12|PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).|Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.||Participants|||Number
108335|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF|In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
108336|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF|Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||percentage of total sleep time||Standard Error|Least Squares Mean
108337|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF|Stage N1 is considered “light sleep,” during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as “somnolence” or “drowsy sleep.” Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
108338|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF|"The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: In the past week, how severe was your sleep disturbance due to your RLS symptoms?. The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
108339|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF|The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.||scores on a scale||Standard Error|Least Squares Mean
108340|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||limb movements per hour||Standard Error|Least Squares Mean
108341|NCT00748098|Primary|Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)|"PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a sleep study that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.||minutes||Standard Error|Least Squares Mean
108342|NCT00748085|Secondary|Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.||1 year|no analysis conducted. Study terminated for business reasons|||||
108589|NCT00745030|Secondary|Changes in Mean TST, LPS, WASO (Based on PSG)||8 weeks||||||
108347|NCT00746356|Primary|Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis.||Volts||Standard Deviation|Mean
108348|NCT00746356|Primary|Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis.||Volts||Standard Deviation|Mean
108349|NCT00746356|Primary|Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis.||Volts||Standard Deviation|Mean
108350|NCT00746356|Primary|Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.|3 months post implant|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis.||Volts||Standard Deviation|Mean
108351|NCT00746356|Primary|Percentage of Participants Free of System-related Complications at 3-months Post Implant||3 months post implant|||Percentage of Participants|||Number
108352|NCT00746330|Secondary|Urinary Excretion of Formoterol Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in urine was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for urine was 0.0174 nmol/L expressed as free base. The amounts of unchanged formoterol excreted in urine from 0 to 3 hours (Ae0-3) and from 0 to 12 hours post-dose (Ae0-12) were calculated from the formoterol concentrations in urine and the urine volumes using non-compartmental methods.|0 to 3 hrs and 0-12 hrs|The pharmacokinetic population which was modified by the exclusion of dosing periods where formoterol was present at a concentration in excess of 5% of the Cmax.Five subjects were excluded due to various reasons.||nmol||90% Confidence Interval|Least Squares Mean
108353|NCT00746330|Secondary|Plasma Formoterol Concentrations (Pmol/L) Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in plasma was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for plasma was 1.45 pmol/L. No non-compartmental PK analysis was performed.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Because of the dosing periods where formoterol was present at concentrations greater than 5% of the Cmax data for 4 subjects was excluded. A dosing error resulted in the exclusion of 1 subject and 1 subject had all data excluded from PK evaluation due to the plasma drug concentrations in conflict with the recorded randomization.||pmol/L||Standard Deviation|Mean
108354|NCT00746330|Secondary|Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS/ERS standards|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
108355|NCT00746330|Secondary|Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FVC is the volume (liters) of air that can forcibly be blown out after full inspiration. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS / ERS standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
108356|NCT00746330|Secondary|Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FEV1 is the maximum amount of air expired in one second. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the (ATS / ERS) standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
108357|NCT00746330|Primary|The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment|For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose|From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment).|Full Analysis Set||liters||95% Confidence Interval|Least Squares Mean
108358|NCT00747916|Secondary|To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent.||1 year|zero participants analyzed due to early termination of study|||||
108359|NCT00747916|Primary|To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.||1 year|zero participants analyzed due to early termination of study|||||
108360|NCT00747812|Primary|Number of Days With 4 or More Hours of Headache||12 Weeks|||Days||Standard Deviation|Mean
108361|NCT00747812|Primary|Number of Hours of Headache||12 weeks|||Hours||Standard Deviation|Mean
108362|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After two weeks|||percentage of patients|||Number
108363|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After one week|Eligibility according to in/ex criteria and compliance with study requirements||percentage of patients|||Number
108364|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)|After two weeks|||percentage of patients|||Number
108365|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups."|After two weeks|||percentage of patients|||Number
108366|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups"|After one week|Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements||percentage of patients|||Number
108367|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)|After one week|The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements.||percentage of patients|||Number
108368|NCT00747643|Secondary|A Measure of the Subjective Expected Value of a Cigarette|The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).|3 weeks per participant|Per Protocol||Dollars||Standard Error|Mean
108369|NCT00747643|Primary|Cue-provoked Cravings|"Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale How strong was your craving to smoke a cigarette?"|3 weeks per participant|Per Protocol||Scores on a scale||Standard Error|Mean
108370|NCT00747643|Secondary|Smoking Topography - Number of Puffs on a Cigarette|# Puffs = total number of puffs taken at Assessment Session.|3 weeks per participant|Per Protocol||Puffs on a Cigarette||Standard Error|Mean
108371|NCT00747643|Primary|Tonic Craving Score (QSU) Based on Self Reports|Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.|3 weeks per participant|Per Protocol||Scores on a scale||Standard Error|Mean
108372|NCT00747617|Secondary|Serum Testosterone Responses to hCG||-0.5, 0, 0.5, 24 hrs||||||
108373|NCT00747617|Primary|Serum 17OHP Responses to hCG|Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects|24 hrs post dose|PCOS and Normal groups were analyzed according to peak 17OHP levels at each dose of r-hCG.||ng/ml||Standard Error|Mean
108406|NCT00746239|Secondary|Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.||10 weeks||||||
108374|NCT00747565|Primary|Mean Binocular Distance Corrected Near Visual Acuity in Snellen|Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.|One year|Binocular subjects at one year available for testing for both studies combined.||Mean Snellen Line (with ETDRS line SD)||Standard Deviation|Mean
108375|NCT00747565|Primary|Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.|"Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,first eye refers to the first implanted eye of each subject."|One year|First eye results from subjects at one year in both the original study and the expansion study combined.||Participants (First Eyes only)|||Number
108376|NCT00747552|Secondary|Median Bladder Pressure for All Measurements|Intra-abdominal Pressure (IAP) measurements will be tabulated and frequency distributions determined for patients with and without any clinical/surgical abdominal pathology. Median and quartile values will be assessed in order to describe normative values. In patients with clinical abdominal pathology (abdominal distention, necrotizing enterocolitis, abdominal wall defects, diaphragmatic hernia, etc), sequential evaluation of IAP will be done to try to identify thresholds for Intra-abdominal Hypertension (IAH).|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.||mmHg||Inter-Quartile Range|Median
108377|NCT00747552|Primary|Intra-abdominal Pressure(IAP) Measurements in NICU Patients.|Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.||IAP measurements|||Number
108378|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108379|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108380|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108381|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108382|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108383|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
108384|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
108385|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
108386|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
108387|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hr*ng/mL||Standard Deviation|Mean
108407|NCT00746239|Primary|Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.||10 weeks||||||
108590|NCT00745030|Secondary|Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study||8 weeks||||||
108388|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108389|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108390|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108391|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108392|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.||hour||Standard Deviation|Mean
108393|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1h, 1h30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
108394|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
108395|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
108396|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
108397|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.||ng/mL||Standard Deviation|Mean
108398|NCT00747474|Primary|Number of Participants With Adverse Events|Number of participants with AEs that occurred during treatment and follow-up period (30 days after last treatment). Drug-related AEs and SAEs were followed until resolved or stabilized. AEs were classified by the investigator according to severity graded using CTCAE version 3.0 and relationship to study drug. The severity scale is: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to AE|an average of 6 months|Patients received at least one dose of Lipotecan||participants|||Number
108399|NCT00747474|Secondary|Anti-tumor Activity|Patients were evaluated by tumor assessment using RECIST guidelines. Possible evaluations include: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the size of target lesions. Progressive Disease (PD): at least a 20% increase in the size of target lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From start of treatment assessed every 2 cycles up to 2.5 years|Patients received at least one dose of Lipotecan.||participants|||Number
108400|NCT00747474|Primary|Maximum Tolerated Dose (MTD) of Lipotecan|MTD is the highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT)). A 3+3 study design was used to determine MTD. The MTD was the highest dose level at which 0 of 3 or 1 of 6 patients experience a DLT, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.|First treatment to toxicity up to 42 days|Patients received at least one dose of Lipotecan.||mg/m^2|||Number
108401|NCT00747461|Secondary|Treatment Durability|need for additional treatments within specified period|12 months|study terminated-no subjects analyzed.|||||
108402|NCT00747461|Primary|Improvement in Luminal Patency Following Cryospray Treatment||30 days|study terminated by Sponsor-data not analyzed|||||
108403|NCT00747344|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline to Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.||Scores on a scale||Standard Deviation|Mean
108404|NCT00747344|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.||Participants|||Number
110268|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108408|NCT00747227|Secondary|"Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent."|"Subjects indicating a subjective response to a multiple choice question, At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?, on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit."|One Year|Two subjects in the ZV9003 group did not complete the one year questionnaire.||participants|||Number
108409|NCT00747227|Primary|Uncorrected Distance Visual Acuity|Snellen Equivalent of 20/40 or better at one year|One Year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.||participants|||Number
108410|NCT00747227|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|4-6 months|Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.||log contrast||90% Confidence Interval|Mean
108411|NCT00747227|Primary|Best Corrected Distance Visual Acuity|Snellen Equivalent visual acuity of 20/40 or better|One year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.||participants|||Number
108412|NCT00747214|Secondary|Change in Fatigue (MAF Scale) Score From Baseline to Day 42|"The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).~Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5~Sum items #1, 2, and 3~Average items #4 through 14~Add results from above Steps 1 through 3 to obtain a single score~A score was not be assigned to items #4 through 14 if a respondent indicated they did not engage any activity for reasons other than fatigue. If respondent selected “no fatigue” on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index."|Baseline and Day 42|||units on a scale||Standard Deviation|Mean
108413|NCT00747214|Secondary|Change in DAS28 Score From Baseline to Day 42|To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit.|Baseline and Day 42|||units on a scale||Standard Deviation|Mean
108414|NCT00747214|Secondary|Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)|The percentage of subjects in each group that achieved an ACR 20 response on Day 42|Day 42|||percentage of participants|||Number
108415|NCT00747214|Primary|Change in CRP From Baseline to Day 42|The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.|Baseline and Day 42|||percentage change from baseline||Standard Deviation|Mean
108416|NCT00747149|Secondary|Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy||6 and 12 Weeks||||||
108417|NCT00747149|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12||6 and 12 Weeks||||||
108418|NCT00747149|Secondary|Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio||6 and 12 Weeks||||||
108419|NCT00747149|Secondary|Percentage of Subjects Achieving Total Cholesterol (TC)/ High-density Lipoprotein Cholesterol (HDLC) Ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 Weeks of Treatment|Proportion of subjects achieving total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC) ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 weeks of treatment|6 and 12 Weeks||||||
108420|NCT00747149|Primary|Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy|The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100|12 Weeks|||Percentage||95% Confidence Interval|Mean
108421|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
108422|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
108423|NCT00747006|Secondary|Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
109162|NCT00738673|Secondary|Change From Baseline in Serum Levels of Testosterone at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||ng/mL||Standard Deviation|Mean
108424|NCT00747006|Secondary|Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
108425|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||mg/dL||Full Range|Mean
108426|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||mg/dL||Full Range|Mean
108427|NCT00747006|Primary|Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI||mg/dL||Full Range|Mean
108428|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI||mg/dL||Full Range|Mean
108429|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
108430|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered||min*mg/dL||Full Range|Mean
108431|NCT00747006|Primary|Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
108432|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI||min*mg/dL||Full Range|Mean
108433|NCT00746954|Primary|Apnea-hypopnea Index (Number of Central and Mixed Apneas/Hour of Sleep)||Overnight polysomnogram over 3 separate nights|Comparisons among Drugs (not Arms)||APNEA-HYPOPNEA/HR by drug or placebo||Standard Deviation|Mean
108434|NCT00746941|Secondary|Participants Who Died Within 6 Months|The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen.|Day 1 up to 6 months|"Safety population: All participants who enrolled in the study and were dosed, and who have at least 1 post-baseline safety assessment.~The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen."||participants|||Number
108435|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||log10 mm^3||Standard Deviation|Mean
108436|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||log10 mm^3||Standard Deviation|Mean
108437|NCT00746941|Secondary|Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||participants|||Number
126961|NCT00578812|Secondary|Neck Pain Visual Analog Scale|Improvement of ≥20mm in neck pain at 24 months compared to baseline.|24 Months|per protocol||participants|||Number
108438|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS)|"Participants rate their neurological function on a scale of 100 mm line, where the 0 end of the scale indicates poor neurological function and 100 indicates excellent neurological function. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
108439|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT)|"The SDMT is a simple substitution task. The test gives participants 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0 (worst outcome) to 110 (best outcome).~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. SDMT was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
108440|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score|"The KPS Index classifies participants' functional impairment. KPS can be used to compare effectiveness of different therapies and to assess the prognosis in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the KPS score, the worse the survival for most serious illnesses. The KPS index is subdivided into 3 categories: incapacitated (0 to 40), self-care (50 to 70), and normal activity (80 to 100).~Negative change from baseline scores indicate improved prognosis."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
108441|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death) was calculated. Negative change scores indicate improvement.|Day 0 (baseline), Week 4 and 8|"Participants with values at the time frames being measured. EDSS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."||units on a scale||Standard Deviation|Mean
108442|NCT00746941|Primary|Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 8 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 8|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 8 were available."||log10 copies/mL||Standard Deviation|Mean
108443|NCT00746941|Primary|Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 4 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 4|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 4 were available."||log10 copies/mL||Standard Deviation|Mean
108444|NCT00746889|Other Pre-specified|Change in WOMAC Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 12 weeks|These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.||units on a scale||Standard Deviation|Mean
108445|NCT00746889|Primary|Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 4 weeks|This population was defined as patients who completed the 4 week follow up assessment as per protocol.||units on a scale||Standard Deviation|Mean
108446|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.|At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|24 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.||cm||Standard Deviation|Mean
108447|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.|At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|6 hours postoperative from mid-urethral sling placement|Intention to treat||cm||Standard Deviation|Mean
108448|NCT00746863|Secondary|Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.|Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.|From after surgery to discharge from hospital.|||participants w/sucessful voiding trial|||Number
110269|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108450|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.|At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|2 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.||cm||Standard Deviation|Mean
108451|NCT00746798|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.||Day 0 up to Day 14 post-vaccination|Safety assessments were on the Safety, intend-to-treat Population.||Participants|||Number
108452|NCT00746798|Primary|Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|"Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test.~Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10."|Day 0 and Day 28 post-vaccination|Serum antibody levels and seroconversion were assessed in the per-protocol population.||Participants|||Number
108453|NCT00746798|Secondary|Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units [pfu]/mL) viremia at the reported visit.|Day 2 up to Day 14 post-vaccination|Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.||Participants|||Number
108454|NCT00746798|Primary|Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine|Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.|Day 0 and Day 28 post-vaccination|Serum antibody levels were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
108455|NCT00746785|Primary|Drinks Per Drinking Day|"Drinks are measured as the number of standard alcoholic beverages consumed each day, assessed in varying lengths of time (i.e., 2 weeks, 4 weeks, 6 weeks, etc.). A standard alcoholic beverage is equivalent to: 1, 12 oz. regular beer; 1, 5 oz. glass of wine; 1, mixed drink with one1.5 oz shot; or 1, 1.5 oz shot. A drinking day is measured as any day of the week in which an alcoholic beverage is consumed. Data for drinks per drinking day is gathered using the Time Line Follow Back method in which participants are asked to recall their alcohol consumption day by day for a pre-defined set of time."|up to 36 weeks|||Drinks per drinking day||Standard Deviation|Mean
108456|NCT00746733|Primary|T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
108457|NCT00746733|Primary|AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||ng.h/ml||Standard Deviation|Mean
108458|NCT00746733|Primary|Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
108459|NCT00746733|Primary|Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population||ng/ml||Standard Deviation|Mean
108460|NCT00746733|Primary|T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
108461|NCT00746733|Primary|AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC||0 through 96 hours after dosing|PK population||ng.h/ml||Standard Deviation|Mean
108462|NCT00746733|Primary|Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
108463|NCT00746733|Primary|Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||ng/ml||Standard Deviation|Mean
108464|NCT00746733|Secondary|Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Pre-dose, 2 and 8 hours after dosing|Safety population||msec||Standard Deviation|Mean
108465|NCT00746733|Secondary|Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population||bpm||Standard Deviation|Mean
108466|NCT00746733|Secondary|Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population||mmHg||Standard Deviation|Mean
108467|NCT00746733|Primary|Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
108468|NCT00746733|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||ng.h/ml||Standard Deviation|Mean
108469|NCT00746733|Primary|Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population||h||Standard Deviation|Mean
108470|NCT00746733|Secondary|Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.||mmHg||Standard Deviation|Mean
108471|NCT00746733|Secondary|DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population||units on a scale||Standard Deviation|Mean
108472|NCT00746733|Secondary|DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population||units on a scale||Standard Deviation|Mean
108473|NCT00746733|Secondary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.||units on a scale||Standard Deviation|Mean
108474|NCT00746733|Primary|Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.||ng/ml||Standard Deviation|Mean
108475|NCT00746694|Primary|Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE|The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.|Participants will do a single visit, but cases will be collected during a period of 12 months.|||Participants|||Number
108476|NCT00746694|Primary|Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)|"Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE.~Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it."|Participants will do a single visit, but cases will be collected during a period of 12 months.|||Participants|||Number
108477|NCT00746668|Primary|Sentence Reading|To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).|Pre-training, 6 weeks, 12 weeks, 18 weeks|Intent to Treat||Words per Minute (wpm)||Standard Deviation|Mean
108478|NCT00746590|Secondary|Changes in Laboratory Measurements||Baseline and every 3 weeks until progression||||||
108479|NCT00746590|Secondary|Adverse Events||Until progression||||||
108480|NCT00746590|Secondary|Changes in Alpha Fetoprotein||Baseline, every 3 weeks until progression||||||
108481|NCT00746590|Secondary|Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour||Every 6 weeks until progression||||||
108482|NCT00746590|Secondary|Time to Tumour Progression||Every 3 weeks until progression||||||
108483|NCT00746590|Secondary|Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease||Approximately 12 weeks or more after first treatment with Prolarix||||||
108484|NCT00746590|Primary|Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST||every 6 weeks until progression|Study was terminated prematurely after only 1 patient was enrolled. The patient died one month after the initial dose of Prolarix, but his death was unrelated to Prolarix administration.||participants||Standard Deviation|Mean
108485|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase II|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.|6 weeks|All patients implanted with the SJM Confirm device in participating in Phase II. Total patients 36: (19 rollovers from Phase I enrollments)+(25 Phase II enrollments)-(1 withdrawal)-(7 subjects with no automatically triggered recordings). Total recordings obtained: 958||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
108486|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase I|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes).||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
108487|NCT00746564|Other Pre-specified|Interpretability of Automatically Triggered/Symptom Driven Recordings|The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes). Total analyzable recordings 2804.||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
145258|NCT00425269|Secondary|Triglycerides, Post-test||post-test, after completion of all six group sessions|||mmol/L||95% Confidence Interval|Mean
108488|NCT00746564|Other Pre-specified|Interpretability of Weekly Subject Activator Recordings|The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 30; 50-(1 withdrawal)-(19 patients who did not initiate recordings). Total analyzable recordings 58.||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
108489|NCT00746564|Primary|Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers|The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 92: 96 obtained-(4 recordings with zero visible R waves)||percentage of recordings|Participants|95% Confidence Interval|Number
108490|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 45; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel)-(2 patients where no recording was obtained). Total analyzable recordings 45: 46 obtained-(1 recording with zero visible R waves).||percentage of recordings|Participants|95% Confidence Interval|Number
108491|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings at Rest|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.||percentage of recordings|Participants|95% Confidence Interval|Number
108492|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings||percentage of recordings|Participants|95% Confidence Interval|Number
108493|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).||percentage of recordings|Participants|95% Confidence Interval|Number
108494|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings at Rest|The sensitivity was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).||percentage of recordings|Participants|95% Confidence Interval|Number
108495|NCT00746551|Secondary|Haemoglobin Level||3 weeks after intervention|||g/dL||Standard Deviation|Mean
108496|NCT00746551|Primary|Serum Ferritin Level||3 weeks after intervention|||µg/dL||Standard Deviation|Mean
108497|NCT00746187|Primary|Marginal Bone Level Changes|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.|3 years after implant placement (baseline)|Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis.||millimeter|Participants|Standard Deviation|Mean
108498|NCT00746096|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks|||units on a scale||Standard Deviation|Mean
108499|NCT00746096|Primary|Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|"Five patients in the IKH-01 group were excluded from efficacy analysis due to no available data for 3 patients and 2-4 administration days for 2 patients.~One patient in the placebo group was also excluded from efficacy analysis."||units on a scale||Standard Deviation|Mean
108500|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Acceptance Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
108501|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Awareness Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
145259|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Post-test||post-test, after completion of all six group sessions|||mmol/L||95% Confidence Interval|Mean
108502|NCT00745940|Secondary|Symptom Checklist-90 Revised (Depression Subscale)|The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from “Not at All” to “Extremely” with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
108503|NCT00745940|Primary|Beck Depression Inventory - II|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders—Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
108504|NCT00745940|Secondary|Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27."|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.|||units on a scale||Standard Deviation|Mean
108505|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Participants|||Number
108506|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 2|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Participants|||Number
108507|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 1|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
108508|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Participants|||Number
108509|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 2|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Participants|||Number
108510|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 1|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
108511|NCT00745901|Primary|Overall Number of Days of Total Blood Loss|cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 to 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
108512|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 3 (Day 57 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Days||Standard Deviation|Mean
108513|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 2 (day 29 to Day 56)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Days||Standard Deviation|Mean
110270|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108514|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 (Day 8 to Day 28)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
108515|NCT00745901|Primary|Overall Number of Days of Scheduled Blood Loss|summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 to Cycle 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
108516|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Days||Standard Deviation|Mean
108517|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Days||Standard Deviation|Mean
108518|NCT00745901|Primary|Number of Days of Scheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
108519|NCT00745901|Primary|Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes|Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
108520|NCT00745901|Primary|Overall Number of Days of Unscheduled Blood Loss|cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
108521|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 3|Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.||Days||Standard Deviation|Mean
108522|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.||Days||Standard Deviation|Mean
108523|NCT00745901|Secondary|Patient Satisfaction - Overall|patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.|Cycle 1 to Cycle 3|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Participants|||Number
108524|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.||Days||Standard Deviation|Mean
108525|NCT00745875|Secondary|Progression-free Survival|Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method|Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation|||Days||Full Range|Median
108526|NCT00745875|Primary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)|Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).|||Days||Full Range|Median
145260|NCT00425269|Secondary|Insulin, 2-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
108532|NCT00745823|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count||Baseline and Week 48|Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy.||cells/mm^3||95% Confidence Interval|Mean
108533|NCT00745823|Primary|Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.||Participants|||Number
108534|NCT00745823|Primary|Number of Participants With One or More Adverse Events at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.||Participants|||Number
108535|NCT00745823|Secondary|Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks||48 weeks|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.||Participants|||Number
108536|NCT00745823|Primary|Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks||Week 48|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.||Participants|||Number
108537|NCT00745498|Secondary|Postoperative Resolution of Neovascularization||6 months||||||
108538|NCT00745498|Secondary|Visual Outcome|Best-corrected visual acuity (BCVA) at postoperative 6 months|6 months|||logMAR||Standard Deviation|Mean
108539|NCT00745498|Secondary|Initial Time of Vitreous Clearing (ITVC)|The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.|6 months|||days||Standard Deviation|Mean
108540|NCT00745498|Primary|Recurrent VH Incidence (Early and Late)|"Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. Early recurrent VH was VH occurring <= 4 weeks and late recurrent VH was VH occurring >4 weeks after surgery."|6 months|With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis.||Percentage of participants|||Number
108541|NCT00744380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|The HADS consists of 14 questions, seven for anxiety and seven for depression. Each item is scored from 0 to 3, with a cut-off cumulative score of 11 for both subscales indicative of anxiety or depression. This scoring tool has been used for 30 years, possesses excellent reliability and validity, and avoids reliance conditions that are also common somatic symptoms of illness such fatigue, insomnia, and hypersomnia. The maximum score for each subscale is 21 with a maximum possible cumulative score of 42. The minimum score for each subscale is 0. The minimum cumulative score is 0|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the HADS were provided the assessment. Seven subjects were excluded.||units on a scale||Standard Deviation|Mean
108542|NCT00744380|Secondary|Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)|The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately often,” 3 = “quite a bit,” and 4 = “extremely often.” The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the IES-R were provided the assessment. Seven subjects were excluded.||units on a scale||Standard Deviation|Mean
108543|NCT00744380|Secondary|Duration of Study Drug Administration||Duration of ICU stay, up to 24 weeks|||days||Inter-Quartile Range|Median
108544|NCT00744380|Secondary|ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)|The ICU-SEQ assesses patient recall of their ICU experience. The ICU-SEQ assesses both psychological (e.g. fearfulness, anxiety) and physical (e.g. pain, difficulty breathing) perceptions of ICU patients who have received mechanical ventilation. It consists of 29 potentially stressful experiences with seven items specifically addressing the endotracheal tube. The extent that patients are bothered by each item is scored on a five point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately,” 3 = “quite a bit,” and 4 = “extremely.” The cumulative score is an integer interpreted as interval data with higher scores indicating greater stressful experiences associated with the ICU. The minimum score is 0 and the maximum score possible is 116.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the ICU-SEQ were provided the assessment. Seven subjects were excluded.||units on a scale||Full Range|Median
108545|NCT00744380|Secondary|Sedation-related Adverse Effects||Duration of ICU stay, up to 24 weeks|||participants|||Number
108546|NCT00744380|Secondary|The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)|The Riker sedation-agitation score (range 1-7) and PABS (range 0-10) are assessed hourly by the bedside nurse. Riker scores assess restlessness and cooperation. Riker scores of 5 – 7 indicate agitation, 3 - 4 represent adequate sedation and 1 - 2 represent excessive sedation. PABS assessments include domains of restlessness, muscle tone, vocalization, consolability, and facial expressions. PABS assessments of 0 represent no pain, 1 - 3 represent mild pain, 4 - 6 represent moderate pain, and ≥ 7 represent severe pain.|Duration of ICU stay, for up to 24 weeks|||percentage of assessments while on study|||Number
108547|NCT00744380|Secondary|Cumulative Doses of Conventional Sedatives and Analgesics||Duration of ICU stay, for up to 24 weeks|||mg||Inter-Quartile Range|Median
108548|NCT00744380|Primary|Time From Study Drug Initiation to Tracheal Extubation||Duration of ICU stay, for up to 24 weeks|The analysis only includes patients successfully extubated for at least 72 hours. Eight subjects were excluded.||days||Inter-Quartile Range|Median
108549|NCT00744328|Secondary|To Explore the Relationship of Remission and Response to the Subjects’ Serum Levels of Estradiol.||Monthly||||||
108550|NCT00744328|Secondary|To Evaluate the Durability of Maternal Response to Estradiol, Sertraline, and Placebo in a Continuation Phase Through the Time the Infant is Assessed at 6.5 Months of Age.||yearly||||||
108553|NCT00744328|Primary|To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29|Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology.|Week 8|Analyses presented are Last Observation Carried Forward. For women who completed the 8 week trial the percent change was measured from baseline to week 8. For non-completers, the percent change was measured from baseline to last observation.||percentage change in SIGH-ADS29 Score||Standard Deviation|Mean
108554|NCT00744263|Other Pre-specified|Percentage of Participants With Newly Diagnosed Chronic Medical Condition|Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.|From 1 month after vaccination up to 6 months after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.||percentage of participants|||Number
108555|NCT00744263|Other Pre-specified|Percentage of Participants Who Died|Deaths collected throughout the case acquisition period were presented.|From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Safety population included all participants who received study vaccine and who had any safety data.||percentage of participants|||Number
108556|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination|Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.|Within 7 days after vaccination|Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.||percentage of participants||95% Confidence Interval|Number
108557|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination|Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.|Within 7 days after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.||percentage of participants||95% Confidence Interval|Number
108558|NCT00744263|Secondary|Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases|VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).|Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.||participants|||Number
108559|NCT00744263|Secondary|Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.|Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.||participants|||Number
108591|NCT00745030|Primary|Change in the Frequency of RBD Based on the Daily Sleep Diaries, Completed Daily for the Duration of the Study by the Study Subjects' Bed Partners/Caregivers|"Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers.~Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment."|12 weeks|||Participants|||Number
157108|NCT00318591|Secondary|Device-related or Possibly Device-related AEs||4-6 months|||Events|||Number
108560|NCT00744263|Primary|Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).|Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.||participants|||Number
108561|NCT00744237|Secondary|Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5|[visit 5(week 0) and visit 14(week 26)]|||Unit on a scale||Standard Deviation|Mean
108562|NCT00744237|Primary|Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26|Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.|visit 5(week 0) and visit 14(week 26)|||Percentage||Standard Deviation|Mean
108563|NCT00745368|Primary|Female Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose|||ratio||Inter-Quartile Range|Median
108564|NCT00745368|Primary|Male Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose|||ratio||Inter-Quartile Range|Median
108565|NCT00745368|Primary|Female Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose|||hours||Inter-Quartile Range|Median
108566|NCT00745368|Primary|Male Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose|||hours||Inter-Quartile Range|Median
108567|NCT00745368|Primary|Female Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
108568|NCT00745368|Primary|Male Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
108569|NCT00745368|Primary|Raltegravir Female Genital Tract Concentration||8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
108570|NCT00745368|Primary|Raltegravir Male Genital Tract Concentration||8-10 hours after raltegravir dose|||ng/mL||Inter-Quartile Range|Median
108571|NCT00745290|Secondary|Number of Participants With Adverse Events Through 96 Hours and Serious Adverse Events Through 30 Days||through 30 days||||||
108572|NCT00745290|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|The subject’s pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?”|through 72 hours post surgery|Note: 245 subjects were randomized and received study drug and were included in the analyses.||Units on a scale*hours||Standard Deviation|Mean
108573|NCT00745251|Secondary|Percent Change in Weight From Baseline to Week 28||baseline to week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
108574|NCT00745251|Primary|Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.|AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep|between baseline and Week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||events/hour||Standard Error|Least Squares Mean
108575|NCT00745095|Secondary|Polyp Detection|The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.|Time of Study|||Number of polyps detected (numerical)||Standard Deviation|Mean
108576|NCT00745095|Primary|Quality of Bowel Preparation|The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.|1-2 days following intervention|||units on a scale||Standard Deviation|Mean
108577|NCT00745030|Secondary|Study Terminated Due to Low Subject Recruitment and Enrollment.|Low subject recruitment and enrollment|||||||
108578|NCT00745030|Secondary|Changes in The Montreal Cognitive Assessment Scale (MoCA)||12 weeks||||||
108579|NCT00745030|Secondary|Changes in Mini-Mental State Exam (MMSE)||12 weeks||||||
108580|NCT00745030|Secondary|Changes in Physician Completed United Parkinson’s Disease Rating Scale (UPDRS)||12 weeks||||||
108581|NCT00745030|Secondary|Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale)||12 weeks||||||
108582|NCT00745030|Secondary|Changes in Patient Completed The Fatigue Severity Scale (FSS)||12 weeks||||||
108583|NCT00745030|Secondary|Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed)||12 weeks||||||
108584|NCT00745030|Secondary|Changes in Beck Depression Inventory (BDI)||12 weeks||||||
108592|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Identification at Week 6.||log10 millisecond||Standard Error|Least Squares Mean
108593|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Identification at Week 3.||log10 millisecond||Standard Error|Least Squares Mean
108594|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Identification at Week 1.||log10 millisecond||Standard Error|Least Squares Mean
108595|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for Visual Learning at Week 6.||arcsine proportion correct||Standard Error|Least Squares Mean
108596|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for Visual Learning at Week 3.||arcsine proportion correct||Standard Error|Least Squares Mean
108597|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for Visual Learning at Week 1.||arcsine proportion correct||Standard Error|Least Squares Mean
108598|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 6.||arcsine proportion correct||Standard Error|Least Squares Mean
108599|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 3.||arcsine proportion correct||Standard Error|Least Squares Mean
108600|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 1.||arcsine proportion correct||Standard Error|Least Squares Mean
108601|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 6|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 6.||errors||Standard Error|Least Squares Mean
108602|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 3|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 3.||errors||Standard Error|Least Squares Mean
108603|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 1|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 1.||errors||Standard Error|Least Squares Mean
108616|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set||Participants|||Number
108604|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Detection at Week 6.||log10 millisecond||Standard Error|Least Squares Mean
108605|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Detection at Week 3.||log10 millisecond||Standard Error|Least Squares Mean
108606|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Detection at Week 1.||log10 millisecond||Standard Error|Least Squares Mean
108607|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 6|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 6|FAS. N = number of participants with a NPI total score at Week 6.||scores on scale||Standard Error|Least Squares Mean
108608|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 3|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 3|FAS. N = number of participants with a NPI total score at Week 3.||scores on scale||Standard Error|Least Squares Mean
108609|NCT00744978|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 6|FAS; N = number of participants with a CGI-I score at Week 6.||units on a scale||Standard Error|Least Squares Mean
108610|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 6|FAS. N = number of participants with ADAS-Cog 70 results at Week 6.||units on scale||Standard Error|Least Squares Mean
108611|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 3|FAS. N = number of participants with ADAS-Cog 70 results at Week 3.||units on scale||Standard Error|Least Squares Mean
108612|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 3|FAS; N = number of participants with ADAS-Cog 75 results at Week 3.||units on scale||Standard Error|Least Squares Mean
108613|NCT00744978|Primary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 6|Full analysis set (FAS): all participants who were randomized and took at least 1 dose of randomized study medication. N = number of participants with ADAS-Cog 75 results at Week 6.||units on scale||Standard Error|Least Squares Mean
108614|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
108615|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
108617|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set.||Participants|||Number
108618|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle ore epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
108619|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
108620|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set||Participants|||Number
108621|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set||Participants|||Number
108622|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
108685|NCT00744523|Secondary|Target Lesion Revascularization at 30 Days|Number of subjects with any repeat invasive procedure, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase lumen diameter inside or within 10 mm of the previously treated lesion.|Up to 30 days after the procedure was performed|||participants|||Number
157109|NCT00318591|Secondary|Nurse Time Spent on Catheterization Procedure||4-6 months|ITT-population||seconds||Standard Deviation|Mean
108623|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.||Participants|||Number
108624|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set||Participants|||Number
108625|NCT00744939|Primary|Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set||Participants|||Number
108626|NCT00744874|Secondary|Total Fluoroscopy Time|Total time that flouroscopy was used during the ablation procedure.|Post Ablation Procedure|||minutes||Standard Deviation|Mean
108627|NCT00744874|Secondary|Total Procedure Time|Measurement of total procedure time defined as “skin to skin” and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)|End of Procedure|||minutes||Standard Deviation|Mean
108628|NCT00744874|Secondary|Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins|Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation|After Procedure|||minutes||Standard Deviation|Mean
108629|NCT00744874|Secondary|The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline|The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score.|6 months|||units on a scale||Standard Deviation|Mean
108630|NCT00744874|Secondary|Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months|Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).|6 Months|||units on a scale||Standard Deviation|Mean
108631|NCT00744874|Primary|Chronic Safety|The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|7 day post procedure to 6 months|The Chronic Safety Endpoint is the proportion of subjects with serious procedure and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.||participants|||Number
108632|NCT00744874|Primary|Acute Safety|The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.|7 days post procedure|The proportion of subjects with one or more serious procedure and/or device related AEs occurring within 7 days of the ablation procedure. No acute events were related to the device.||participants|||Number
108686|NCT00744523|Secondary|Restenosis at 30 Days|Number of subjects with re-narrowing of the lesion at 30 days as defined as a >= 50% stenosis measured by duplex ultrasound scan.|Up to 30 days after the procedure was performed|||participants|||Number
108633|NCT00744874|Primary|Chronic Effectiveness|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.|6 months|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.||participants|||Number
108634|NCT00744874|Primary|Number of Participants With Successful Pulmonary Vein Isolation|Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.|6 months|Subjects that had successful pulmonary vein isolation.||participants|||Number
108635|NCT00744848|Secondary|Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30||through day 30||||||
108636|NCT00744848|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?”|through 96 hours|Note: 204 randomized subjects received study drug and were included in the analyses.||Units on a scale*hours||Standard Deviation|Mean
108637|NCT00744757|Secondary|Quality of Life Assessment|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.|Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)|ITT population was defined as all participants who had received at least 1 dose of study medication.||Unit on a scale||Standard Deviation|Mean
108638|NCT00744757|Secondary|Number of Events Which Led to Hospitalization|The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.|Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Events|||Number
108639|NCT00744757|Secondary|Duration for Hospitalization|Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.|Cycle 1 up to Cycle 8, each cycle of 28 days.|ITT population was defined as all participants who had received at least one dose of treatment. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.||Days||Standard Deviation|Mean
108640|NCT00744757|Secondary|Percentage of Participants With Transfusion Independency|Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.|8 weeks before first dose and 736 days of treatment|ITT population was defined as all participants who had received at least 1 dose of study medication.||percentage of participants|||Number
108641|NCT00744757|Secondary|Percentage of Participants With Transfusion Dependency|Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.|8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Percentage of participants|||Number
108642|NCT00744757|Secondary|Overall Survival|Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Months||Full Range|Median
108643|NCT00744757|Secondary|Time to Acute Myeloid Leukemia (AML) Progression or Death|Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.||Months||Full Range|Median
108644|NCT00744757|Secondary|Percentage of Participants With Cytogenetic Response|Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated at given time point.||Percentage of participants|||Number
108687|NCT00744523|Secondary|Procedural Success|"Number of subjects with technical success without the occurrence of any MACCE or unresolved antegrade flow blockage intolerance during the index hospitalization.~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure through hospital discharge|||participants|||Number
110271|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108645|NCT00744757|Secondary|Percentage of Participants With Hematologic Treatment Response|Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here ‘N’ specifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluable for this outcome measure at given time point.||Percentage of participants|||Number
108646|NCT00744757|Primary|Percentage of Participants With Response|Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here ‘N’ specifies those participants who were evaluable for this outcome measure.||Percentage of Participants|||Number
108647|NCT00744692|Secondary|To Describe the Pace of Platelet Recovery|Platelet engraftment was defined as the first day of platelet counts more than 50,000/uL for 7 consecutive days without transfusions|180 days post transplant|||days||Full Range|Median
108648|NCT00744692|Secondary|To Evaluate the Incidence of Late Graft Failures at 2 Years Post-transplant||2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late graft failure endpoint.||participants|||Number
108649|NCT00744692|Secondary|To Evaluate Long-term Complications, Such as Sterility, Endocrinopathy, and Growth Failure||at least 2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late effects endpoint.||percentage of patients|||Number
108650|NCT00744692|Secondary|To Describe the Incidence of Grade 3-4 Organ Toxicity||2 years post transplant|||participants|||Number
108651|NCT00744692|Secondary|To Describe Incidence of Acute Graft Versus Host Disease (GVHD) (II - IV)|To describe incidence of acute Graft Versus Host Disease (GVHD) (II - IV) : measured by cumulative incidence analysis|100 days post transplant|||percentage of participants||95% Confidence Interval|Number
108652|NCT00744692|Secondary|To Determine the Overall Survival at day180 Post-transplant|To determine the overall survival at day180 post-transplant: determined by Kaplan Meier survival analysis|180 days|||percentage of participants||95% Confidence Interval|Number
108653|NCT00744692|Secondary|To Evaluate the Pace of Immune Reconstitution.|Immune reconstitution after RIC in UCBT was described. CD4 count is a standard measure of immune reconstitution and is described here. Additional data is available upon request.|1 year post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of Immune reconstitution endpoint. CD4 count is reported here.||cells/uL||Full Range|Median
108654|NCT00744692|Secondary|To Describe the Pace of Neutrophil Recovery|Neutrophil recovery was defined as the first day of an absolute neutrophil count (ANC) more than 500/uL for 3 consecutive days not secondary to granulocyte infusions|42 days post transplant|||days||Full Range|Median
108655|NCT00744692|Primary|Determine the Feasibility of Attaining Acceptable Rates of Donor Cell Engraftment (>25% Donor Cells at 180 Days) Following RIC Regimens in Children < 21 Years Receiving UCBT for Non-malignant Disorders.|Determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor cells at 180 days) following reduced intensity conditioning regimens in children < 21 years receiving cord blood transplant for non-malignant disorders.|180 days post transplant|Of the 22 patients enrolled, 18 patients were alive at 180 days, the time-point for primary end point||% of participants|||Number
108656|NCT00744653|Secondary|Safety and Toxicity||up to 1 year|per protocol||adverse events|Participants||Number
108657|NCT00744653|Secondary|Participants With Objective Response Evaluated With PET/CT|Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.|3, weeks, 8 weeks, and up to 6 months after treatment|per protocol||participants|||Number
108658|NCT00744653|Primary|Clinical Measure of Lesion Size.|Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size|up to one year|Based on Simons optimal design for phase II trials, 25 evaluable patients were to be included and treated.||Participants|||Number
108659|NCT00744627|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set.||participants|||Number
108688|NCT00744523|Secondary|Technical Success|"Number of subjects with device success and the ability to successfully implant a carotid stent and obtain a residual stenosis < 30% during the index procedure(as evaluated by the angiographic core laboratory).~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure|Roll-In participants were analysed on the number of roll-in cases performed. Pivotal subjects were analysed as Intention To Treat (ITT).||participants|||Number
108660|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108661|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108662|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108663|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108664|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108665|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108666|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108667|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108689|NCT00744523|Secondary|Device Success|Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.|The entire duration of the index procedure|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria who were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.||participants|||Number
109163|NCT00738673|Secondary|Participants at Testosterone Castrate Level Throughout the Study|Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.|up to month 12|Intent to treat population||participants|||Number
108668|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108669|NCT00744627|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression-Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108670|NCT00744627|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
108671|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108672|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
108673|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2 and 4|"Full analysis set where Baseline data were available. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108674|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108675|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1 and 4|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110140|NCT00732940|Secondary|Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||mmol/L||Standard Error|Mean
108676|NCT00744627|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
108677|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
108678|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
108679|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.||percentage of participants|||Number
108680|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
108681|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
108682|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
108683|NCT00744627|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
108684|NCT00744523|Secondary|Access Site Adverse Events|Number of subjects with adverse events at the percutaneous access site as a result of the index procedure, including bruising, hematoma and bleeding requiring treatment by transfusion of blood products, surgical repair, ultrasound compression or thrombin injection.|Index Procedure through Hospital Discharge|||participants|||Number
110272|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108690|NCT00744523|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure.|Number of subjects with one or more Major Adverse Cardiac and Cerebrovascular Events through 30 days after the procedure. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.|Up to 30 days after the procedure was performed|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.||participants|||Number
108691|NCT00744497|Other Pre-specified|Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study|BL=baseline; OS=on-study|At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated|All participants who were randomized to receive any treatment||Participants|||Number
108692|NCT00744497|Other Pre-specified|Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable||Participants|||Number
108693|NCT00744497|Other Pre-specified|Number of Participants by Maximal On-study Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable||Participants|||Number
108694|NCT00744497|Other Pre-specified|Number of Participants With Abnormal Results in Urinalysis|Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment.||Participants|||Number
108695|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0–10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0–6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment||Participants|||Number
108696|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology|Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment||Participants|||Number
108697|NCT00744497|Other Pre-specified|Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. Drug-related=having certain, probable, possible, or missing relationship to study drug. Drug-related AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count.|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment||Participants|||Number
108698|NCT00744497|Other Pre-specified|Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment||Participants|||Number
108699|NCT00744497|Secondary|Percentage of Participants With a Reduction in Pain Intensity From Baseline|The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.|At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants with a baseline pain intensity of 2 or greater||Percentage of participants||95% Confidence Interval|Number
110273|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
108700|NCT00744497|Secondary|Time to Prostate Specific Antigen (PSA) Progression|PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.|From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
108701|NCT00744497|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.|From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
108702|NCT00744497|Secondary|Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline|The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal.|At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants who entered the study with baseline urinary N-telopeptide values higher than the upper limit of normal (ULN), or ≥60 nmol/mmol creatinine, if ULN was missing||Percentage of participants||95% Confidence Interval|Number
108703|NCT00744497|Secondary|Time to First Skeletal-related Event (SRE)|Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.|From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
108704|NCT00744497|Secondary|Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.|At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)|Participants with at least 1 target lesion at baseline||Percentage of participants||95% Confidence Interval|Number
108705|NCT00744497|Primary|Overall Survival: Time From Randomization to Date of Death|Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.|From randomization to death or date of last contact (maximum reached: 45 months)|All participants who were randomized to receive any treatment||Months||95% Confidence Interval|Median
108706|NCT00744055|Primary|Clinician-Administered PTSD Scale|Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD|12 weeks|||units on a scale||Standard Deviation|Mean
108707|NCT00744055|Primary|Number of Drinking Days|Using the Timeline Follow Back method, a calendar method for assessing drug and alcohol use|12 weeks|||days||Standard Deviation|Mean
108708|NCT00744042|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.||h*U/L||Standard Deviation|Mean
108709|NCT00744042|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Time at maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.||hour||Standard Deviation|Mean
108710|NCT00744042|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax)|Maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose)|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.||U/L||Standard Deviation|Mean
109158|NCT00738673|Secondary|Participants at Testosterone Level <=0.2 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.||participants|||Number
108711|NCT00744042|Primary|Change in Rickets Severity From Baseline to Week 24, Based on Assessment of Skeletal Radiographs Using Radiologic Global Impression of Change (RGI-C)|"A 7-point RGI-C (Radiographic Global Impression of Change) score was used to rate change in rickets severity. Scores ranged from -3 (severe worsening of rickets) to +3 (complete healing of rickets). Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings. Average scores were derived for each patient at each assessment."|24 weeks|ITT (intention to treat)||Units on a scale||Full Range|Median
108712|NCT00743730|Secondary|Parent Satisfaction With the Administration Technique|Parents were asked “Overall, how satisfied were you with the pain relief your child received after surgery?” Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4.|parents, once at the end of study|Data was obtained from parents who completed the satisfaction survey||units on a scale||Standard Deviation|Mean
108713|NCT00743730|Secondary|Side Effect Profile (Administration of Medications to Treat Side Effects)||Daily, for up to 3 months||10/2016||||
108714|NCT00743730|Primary|Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale|Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.|First 24 hours on study|||units on a scale||Inter-Quartile Range|Median
108715|NCT00743717|Primary|Knee Score at 2 Years Post Operation|"The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess success."|within 2 years|||units on a scale||Full Range|Mean
108716|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose||28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.||Participants|||Number
108717|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose||28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.||Participants|||Number
108718|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series||28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.||Participants|||Number
108719|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose|Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Titers||95% Confidence Interval|Geometric Mean
108720|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Toddler Dose|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Titers||95% Confidence Interval|Geometric Mean
108721|NCT00743652|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Titers||95% Confidence Interval|Geometric Mean
108722|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108770|NCT00743197|Secondary|The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction.|no analyses were conducted due to the PI's departure from the institution; all work including analyses ceased upon departure- the study was not transferred with the PI. In addition, the study end points were based on changes between groups (treatment vs. usual care group) at 12 month follow up for both groups - none of the enrolled subjects made it to the final (month 12) visit.|1 year||||||
108723|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108724|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108725|NCT00743652|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
108726|NCT00743652|Other Pre-specified|GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
108727|NCT00743652|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
108728|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108729|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108730|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108792|NCT00741936|Secondary|Success of Blinding|The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken.|End of follow-up (Wk18)|Only for subjects attended the last follow-up visit on Wk 18.||participants|Participants||Number
157646|NCT00312884|Primary|Number of Hospitalisations (All Cause)||from randomisation for 180 days|||Number of hospitalisations|||Number
108731|NCT00743652|Other Pre-specified|Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC|In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC’s AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC.|Baseline to 6 months after last vaccination|Safety Population||Participants|||Number
108732|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2|Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
108733|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1|Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
108734|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
108735|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population: all participants who received at least 1 dose of 13vPnC; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic||Percentage of Participants|||Number
108736|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108737|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108738|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108739|NCT00743652|Secondary|Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108843|NCT00742508|Primary|Mean Change From Baseline in Weight at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||kilograms (kg)||Standard Deviation|Mean
108740|NCT00743652|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108741|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108742|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population: received treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
108743|NCT00743574|Primary|AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months|AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT|3 months|Number determined by all participants who completed all interventions and procedures||mg/min/120min||Standard Deviation|Mean
108744|NCT00743574|Primary|AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months|Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT|3 months|Number determined by completion of all study interventions and procedures||µIU/ml/120min||Standard Deviation|Mean
108745|NCT00743574|Primary|Fasting Glucose Levels at Completion of Treatment, at 3 Months|Fasting glucose levels drawn after 3 months completion during oral GTT|3 months|Number determined based on all interventions and procedures completed.||mg/dl||Standard Deviation|Mean
108746|NCT00743574|Primary|Fasting Insulin Levels at Study Completion After 3 Month Treatment|Fasting insulin levels at study completion after 3 month treatment|3 months intervention|Number determined by all those who completed all interventions and procedures.||µIU/ml||Standard Deviation|Mean
108747|NCT00743574|Primary|Participants Were Assessed at Study Completion After 3 Month Treatment|Fasting HbA1C levels at study completion after 3 month treatment|Completion|Number determined by those who completed all interventions and procedures.||percentage||Standard Deviation|Mean
108748|NCT00743574|Secondary|Serum Levels of C-reactive Protein at Completion of 3 Months Treatment Compared to Baseline.|Serum levels of C-reactive protein upon completion, at 3 months|3 months|All subjects who completed treatment for 3 months||mg/L||Inter-Quartile Range|Median
108749|NCT00743509|Secondary|Median Overall Survival Time|Median overall duration of survival.|48 weeks|All patients who completed at least one 28 day cycle||days||95% Confidence Interval|Median
108750|NCT00743509|Primary|Number of Patients Alive Without Disease Progression|Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria. Disease progression is defined as a greater than or equal to 25% increase in the sum of the product of target lesions, or unequivocal progression of non-target lesions or the appearance of new tumor lesions >10mm.|6 months|Patients that tolerated and completed at least one 28 day cycle of therapy were considered evaluable||participants|||Number
108751|NCT00743483|Primary|The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)|"The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level.~CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed).~Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period.~Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method.~The unit of CFA is %"|Final 3 days of baseline and treatment period|Per protocol||% CFA||Standard Deviation|Mean
108752|NCT00743444|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.|The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here.|0-12 hours post first dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 1 patient was excluded from the pharmacokinetic analysis due to error in dose administration at dose 2.||μmol*hours / L||Standard Deviation|Geometric Mean
108753|NCT00743444|Secondary|Total Number Reflux Episodes 0-24 Hours Post First Dose|Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.|0-24 hours|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from this analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 2 due to insufficient impedance/pH recording time.||Episodes||95% Confidence Interval|Geometric Mean
108754|NCT00743444|Primary|Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose|"The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133).~The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment."|0-3 hours post meal, post third dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from the primary analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 1 due to low LESP, 1 due to multiple swallowing.||Relaxations||95% Confidence Interval|Geometric Mean
108755|NCT00743431|Primary|Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)|"Definitions in assessment of adverse event severity:~Mild: awareness of sign, symptom, or event, but easily~tolerated.~Moderate: discomfort enough to cause interference with usual~activity and may warrant intervention.~Severe: incapacitating with inability to do usual activities or~significantly affects clinical status, and warrants~intervention."|The observational program was conducted over a period of 2 years|Intent-to-treat (ITT) (N=214). This is also the Safety population.||Events|||Number
108756|NCT00743288|Primary|Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan|Responses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.|24 months|||participants|||Number
108757|NCT00743288|Primary|MTD|Phase 1: to determine MTD of melphalan in combination with panobinostat to be used in the Phase 2 portion of the study|12 months|||mg/kg melphalan|||Number
108758|NCT00743288|Primary|Maximum Tolerated Dose (MTD)|Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study|12 months|MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.||mg LBH589|||Number
108759|NCT00743288|Secondary|Time to Progression||Time from the start of treatment to progressive disease|All cohorts were analyzed||months||Full Range|Median
108760|NCT00743288|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death|Only three patients had responses.||months||Full Range|Median
108761|NCT00743275|Primary|Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)|Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation|21 days post-vaccination|Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)||Percentage of Participants|||Number
108762|NCT00743275|Primary|Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)|Seroprotection was defined as post-vaccination titer value of ≥ 1:40.|21 days post-vaccination|Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)||Percentage of Participants|||Number
108763|NCT00743275|Primary|Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation||Day 0 and 21 days post-vaccination|Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)||Titers||95% Confidence Interval|Geometric Mean
108764|NCT00743275|Primary|Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering|Days 0-3 post-vaccination|Safety profile was assessed in the intent-to-treat (ITT) population||Participants|||Number
108765|NCT00743262|Secondary|Device Life Time|Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)|one year|||days||Standard Deviation|Mean
108766|NCT00743262|Secondary|Subjective Voice and Speech Quality|Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.|3 weeks|||units on a scale||Standard Deviation|Mean
108767|NCT00743262|Primary|Short-term Feasibility Provox Vega 22.5 French|Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.|3 weeks|||Patients|||Number
108768|NCT00743249|Secondary|Percentage of Subjects Retaining the Stent at Month 3|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|Month 3|Intent to treat||Percentage of subjects|||Number
108769|NCT00743249|Primary|Mean Retention Time|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|From baseline (Day 0) up to Month 3|Intent to treat||Days||Standard Deviation|Mean
109159|NCT00738673|Secondary|Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||IU/L||Standard Deviation|Mean
108771|NCT00743197|Primary|Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED).|The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.|1 year|no analyses were conducted due to PI's departure from institution;all work including analyses ceased upon departure-the study was not transferred with the PI. In addition, study end points were based on changes between groups (treatment vs. usual care)at 12-mo follow up for both groups- none of the enrolled subjects completed the month 12 visit.||participants|||Number
108772|NCT00742183|Primary|Compare the Costs of Using the Interventions (Direct and Indirect)|"The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods.~The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr"|August 2008-August 2009|||dollars||95% Confidence Interval|Mean
108773|NCT00742170|Secondary|Opioid Craving (Self-report)|Self-report on scale of 3 to 30 (higher number indicates more craving)|at 2-weeks post discharge|||units on a scale||Standard Deviation|Mean
108774|NCT00742170|Primary|Percent of Participants Using Drugs||2 weeks following discharge|||percent|||Number
108775|NCT00742079|Secondary|Select Items From the Maudsley Assessment of Delusions Scale||Measured at Baseline, Week 1, and Week 2||||||
108776|NCT00742079|Secondary|Affective Salience Task||Measured at Baseline, Week 1, and Week 2||||||
108777|NCT00742079|Secondary|Bead Task Measuring Probabilistic Reasoning||Measured at Baseline, Week 1, and Week 2||||||
108778|NCT00742079|Secondary|Beck Cognitive Insight Scale (BCIS)||Measured at Baseline, Week 1, and Week 2||||||
108779|NCT00742079|Secondary|Psychotic Rating Scales (PSYRATS)||Measured at Baseline, Week 1 and Week 2||||||
108780|NCT00742079|Secondary|Predictors of Response to D-cycloserine Facilitation of CBT for Delusions in Baseline Characteristics||Measured at baseline||||||
108781|NCT00742079|Primary|Alternative Beliefs Assessment|Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.|Baseline vs. Week 1 vs. Week 2|||units on a scale||Standard Error|Mean
108782|NCT00742053|Primary|Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction|In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.|during catheter insertion|||cm||Standard Deviation|Mean
108783|NCT00741988|Secondary|Characterization of the Toxicity in Patients With Previously Untreated Advanced NSCLC Treated With Ixabepilone and Carboplatin With and Without Bevacizumab.||18 months||||||
108784|NCT00741988|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||months||95% Confidence Interval|Median
108785|NCT00741988|Secondary|Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease||18 months|||months||95% Confidence Interval|Median
108786|NCT00741988|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months|||percentage of participants||95% Confidence Interval|Number
108787|NCT00741936|Secondary|Serum Glutamic Oxaloacetic Transaminase (SGOT)||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
108788|NCT00741936|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
108789|NCT00741936|Secondary|Blood Creatinine Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||μmol/L||Standard Deviation|Mean
108790|NCT00741936|Secondary|Blood Urea Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||mmol/L||Standard Deviation|Mean
108791|NCT00741936|Primary|Responder of Complete Spontaneous Bowel Movement (CSBM)|Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|End of treatment (wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
145261|NCT00425269|Secondary|Insulin, 0-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
108793|NCT00741936|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Wk 6, 10 & wk 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
108794|NCT00741936|Secondary|Changes on Individual Symptom Scores|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
108795|NCT00741936|Secondary|Complete Spontaneous Bowel Movement (CSBM)||Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
108796|NCT00741936|Secondary|Bowel Movement||Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
108797|NCT00741936|Secondary|Responder of Complete Spontaneous Bowel Movement (CSBM)|"Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.~CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours."|End of follow up (wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
108798|NCT00743106|Secondary|To Evaluate the Effects of Lateral Flexion on Patient Hemodynamic Changes as Well as EKG Changes in the Operating Room.||6 weeks post-operatively||||||
108799|NCT00743106|Primary|Glomerular Filtration Rate (GFR) Percentage of Change From Baseline|Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.|percentage of change from baseline to post-operatively day 3|||percentage change||Standard Deviation|Mean
108800|NCT00743093|Secondary|The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).||Days 1-3|A subset of the safety population was monitored for early detection of APAP-cys. This subset of subjects had APAP-cys measured at Days 1, 2, and 3 in addition to other protocol defined timepoints.||participants|||Number
108801|NCT00743093|Primary|The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.|ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.|serial samples for 16-40 days|The total number of subjects completing the trial was used for analysis. Subjects who withdrew early were not included.||participants|||Number
108802|NCT00742924|Secondary|Prognostic Value of Bone Resorption Markers|Blood will be collected for quantification of c-telopeptide and urine will be collected for quantification of n-telopeptide.|At baseline and at weeks 13 and 36||||||
108803|NCT00742924|Secondary|Secondary Limiting Toxicity|"Secondary limiting toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor.~CTC AE version 4 hematologic toxicity will be based on time to blood count recovery to an ANC ≥ 1000/µL and platelet count ≥ 100,000/µL that delays definitive surgery by more than 2 weeks."|After week 13 to the end of protocol therapy||||||
108804|NCT00742924|Secondary|Event-free Survival|The EFS and survival functions will be estimated by the Kaplan-Meier methodology.|Time from study enrollment to disease recurrence, death without disease progression, diagnosis of a second malignant neoplasm, assessed up to 5 years||||||
108805|NCT00742924|Secondary|Histologic Response as Assessed in the Primary Tumor and in Resected Metastases|"Histologic response as graded according to the system of Huvos across all specimens resected at the time of local control in the primary tumor and in resected metastases.~The best response, as quantified by maximum necrosis grading according to the system of Huvos across all specimens resected at the time of local control, will be used to quantify the effect of Induction chemotherapy."|At definitive surgery planned for 12 weeks after the start of protocol therapy.||||||
108806|NCT00742924|Primary|Limiting Toxicity|"The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor."|Enrollment through the first 12 weeks of therapy.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome||participants|||Number
108807|NCT00742885|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 181)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108808|NCT00742885|Secondary|Number of Subjects Reporting Any Medically-significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.|During the 182-day (Days 0-181) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108809|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|From Day 0 to Day 83 following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108810|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108811|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108812|NCT00742885|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108813|NCT00742885|Secondary|Number of Subjects With Any Normal or Abnormal Urine Values|Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108814|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108815|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108816|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108817|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
108818|NCT00742885|Secondary|Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies|"A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182.~The H5N1 vaccine strain included A/Indonesia antigen."|At Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Subjects|||Number
108844|NCT00742508|Primary|Mean Change From Baseline in Heart Rate at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||beats per minute||Standard Deviation|Mean
108819|NCT00742885|Secondary|Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Titer||95% Confidence Interval|Geometric Mean
108820|NCT00742885|Secondary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Subjects|||Number
108821|NCT00742885|Secondary|Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Fold Increase||95% Confidence Interval|Geometric Mean
108822|NCT00742885|Secondary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Subjects|||Number
108823|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.||Titer||95% Confidence Interval|Geometric Mean
108824|NCT00742885|Primary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Subjects|||Number
108825|NCT00742885|Primary|HI Antibody Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Fold Increase||95% Confidence Interval|Geometric Mean
108826|NCT00742885|Primary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Subjects|||Number
108827|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
108828|NCT00742872|Primary|Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.||Within the first 8 weeks of treatment|||participants|||Number
108829|NCT00742781|Primary|25(OH)D3 Serum Levels|25(OH)D3 levels before and after vitamin D supplementation.|6 months|||ng/ml 25(OH)D3||Standard Error|Mean
108830|NCT00742781|Secondary|Health Improvement|International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.|6 months|Activity records for 14 participants were recorded at baseline and after vitamin D supplementation.||units on a scale||Standard Error|Mean
108831|NCT00742781|Primary|Crohn's Disease Activity Index|Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.|6 months|||units on a scale||Standard Error|Mean
108832|NCT00742625|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||months||95% Confidence Interval|Median
108833|NCT00742625|Secondary|Disease-free Survival|Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||months||95% Confidence Interval|Median
108834|NCT00742625|Primary|Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine|"DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs.~Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death."|during consolidation cycle 1 (42 days)|Participants who were registered to bortezomib consolidation were included in the analysis.||participants|||Number
108835|NCT00742625|Primary|Remission Induction Response|"Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML)~A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction.~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL).~A CRp is defined as a CR except platelets < 100,000 mL without need for transfusion."|2 months|||participants|||Number
108836|NCT00742508|Secondary|Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8|Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.||percentage||Standard Deviation|Mean
108837|NCT00742508|Secondary|Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8|Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.||ng/L (nanogram per Liter)||Standard Deviation|Mean
108838|NCT00742508|Secondary|Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8|The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||participants|||Number
108839|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|PD Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)||beats per minute||Standard Error|Mean
108840|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)||millimeters of mercury (mmHg)||Standard Error|Mean
108841|NCT00742508|Primary|Cardiothoracic Ratio at Baseline and Week 8|Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||percentage||Standard Deviation|Mean
108842|NCT00742508|Primary|Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8|There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||participants|||Number
157647|NCT00312884|Primary|Number of Days Spent in Hospital||From randomisation date for 180 days|||days||Inter-Quartile Range|Median
108845|NCT00742508|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||millimeters of mercury (mmHg)||Standard Deviation|Mean
108846|NCT00742508|Primary|Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8|Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||participants|||Number
108847|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Volume at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||femtoliters (fL)||Standard Deviation|Mean
108848|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||picograms (pg)||Standard Deviation|Mean
108849|NCT00742508|Primary|Mean Change From Baseline in Red Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||tebi (2 to the power of 40)/liter (Ti/L)||Standard Deviation|Mean
108850|NCT00742508|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||gibi (2 to the power of 30)/liter (Gi/L)||Standard Deviation|Mean
108851|NCT00742508|Primary|Mean Change From Baseline in Hematocrit at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||proportion of 1 (SI)||Standard Deviation|Mean
108852|NCT00742508|Primary|Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||grams per liter (g/L)||Standard Deviation|Mean
108853|NCT00742508|Primary|Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||percentage of each WBC type in WBC count||Standard Deviation|Mean
108854|NCT00742508|Primary|Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||percentage of Total Creatine Kinase||Standard Deviation|Mean
108855|NCT00742508|Primary|Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||millimoles per liter (mmol/L)||Standard Deviation|Mean
108856|NCT00742508|Primary|Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||micromoles per liter (umol/L)||Standard Deviation|Mean
108857|NCT00742508|Primary|Mean Change From Baseline in Amylase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||units per liter (U/L)||Standard Deviation|Mean
108858|NCT00742508|Primary|Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||international units per liter (IU/L)||Standard Deviation|Mean
145262|NCT00425269|Secondary|C-peptid, 2-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
108859|NCT00742508|Primary|Mean Change From Baseline in Albumin and Total Protein at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.||grams per liter (g/L)||Standard Deviation|Mean
108860|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)||millimeters of mercury (mmHg)||Standard Error|Mean
108861|NCT00742508|Secondary|Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 in group F who gave samples at Week 8 in the CRV-IR group; total of 15 participants, including 4 in group C who gave samples at Week 8 in the SK&F-105517-D group||hours||Full Range|Median
108862|NCT00742508|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Area under the plasma concentration versus time curve from time zero to 24 hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|Pharmacokinetic (PK) Parameter Population: all participants who received the study drug at each dose level and provided sufficient PK concentration data and the data for estimation of PK parameters (total of 13 participants, 3 gave samples at Week 8 in CRV-IR group; total of 15 participants, 4 gave samples at Week 8 in the SK&F-105517-D group)||hours * nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
108863|NCT00742508|Secondary|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 who gave samples in group F at Week 8 in CRV-IR group; total of 15 participants, including 4 who gave samples at Week 8 in the SK&F-105517-D group)||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
108864|NCT00742508|Primary|Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)|Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.|Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D|Safety Population: all participants who received at least one dose of the investigational product||participants|||Number
108865|NCT00742417|Secondary|Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)|Percentage of patients with improved perfusion at the end of the study compared to their initial perfusion. Frontal, parietal and temporal lobes were evaluated from the quantified NeuroGam images. This rendered parametric images showed brain alterations with more than 2 standard deviations with respect to a normal data base. Initial parametric images were compared to the final ones and it was considered perfusion improvement those patients that showed less stretch and/or defect intensity.|End of study|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients||percentage of participants|||Number
108866|NCT00742417|Secondary|Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.|Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by Magnetic Resonance Imaging (MRI). Three measurements were made (week -2 or -1, 20 and 44). It was measured the variations versus the baseline.|Week 00 (baseline), week 20 and week 44|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients||cubic centimetres (cc)||Standard Deviation|Mean
108877|NCT00742326|Primary|Change in Hepatic Steatosis and Hepatic Inflammation/Fibrosis in HIV/HCV Co-infected Patients With Steatosis.|Change in hepatic steatosis and hepatic inflammation/fibrosis in HIV/HCV co-infected patients with steatosis. Change in Hepatic Fat Content measured by MR spectroscopy: 48 weeks compared to Baseline|48 weeks|Two subjects (one in each group) did not have a follow up MRI for comparision to baseline. One developed claustrophobia and could not tolerate MRI and one was discontinued from study due to other illnesses.||percentage of hepatic fat on MRS||Standard Deviation|Mean
109160|NCT00738673|Secondary|Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit|LH is measured in IU/L|Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.||percentage of baseline||Standard Deviation|Mean
108867|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~ADCS-ADL: Alzheimer’s Disease Cooperative Study/Activities Of Daily Living (23 questions describing daily activity of the subject and requests the informer to describe the actions or behaviors observed. Increased autonomy associated to higher scores, maximum of 78 points and minimum of 0)~NPI: Neuropsychiatric Inventory Questions (12 symptom domains scored by frequency [range=0 to 4, higher values being more frequent] and severity [range=1 to 3, higher values being more severe], total score is sum of frequency x severity of all domains)~CDR-Sb: Clinical Dementia Rating (range=0 to 3, higher values being more severe)~ADCS-CGIC: Alzheimer’s Disease Cooperative Study/Clinical Global Impression of Change (7-point Likert scale, 0=not assessed, 1=marked improvement, 2=moderate improvement, 3=minimal improvement, 4=no change, 5=minimal worsening, 6=moderate worsening and 7=marked worsening)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||units on a scale||Standard Deviation|Mean
108868|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~MMSE: Mini Mental State Examination Score (range = 0 to 30, with lower values indicating impairment)~ADAS-Cog: Alzheimer’s Disease Assessment Scale, Cognitive Subscale (range = 0 to 70, with higher values indicating impairment)~NPS (Neuropsychological battery): •SDMT (Symbol Digit Modalities Test, range = 0 to 110, with lower values indicating impairment), •SVF (Semantic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •PVF F, A and S (Phonetic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •BNT (Boston Naming Test, with a maximum of 15 pictures), •RAVLT (Rey Auditory Verbal Learning Test, with 15 words the patient should listen and remind)~CSDD (Cornell Scale for Depression in Dementia, 0 = none; 1 =mild or intermittent; 2 = severe)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||units on a scale||Standard Deviation|Mean
108869|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (Innotest).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using Innotest commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
108870|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
108871|NCT00742417|Secondary|Aβ1−40 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−40 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
108872|NCT00742417|Secondary|P-Tau and Tau CSF Levels Throughout the Study.|Levels of Tau and P-tau in CSF throughout the treatment phase and the follow-up phase (week 44).|Baseline, week 02, week 08, week 20, week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).||pg/mL||Standard Deviation|Mean
108873|NCT00742417|Primary|Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.|Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.|Baseline and up to week 44|The efficacy analyses were performed with the full analysis set (FAS) population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions (or sham procedures) during the intensive treatment phase (the three first weeks of treatment).||pg/mL||95% Confidence Interval|Least Squares Mean
108874|NCT00742391|Secondary|Patients With Partial Clearance of Actinic Keratosis (AKs)|Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.|baseline and 57 days|Intention to treat population||participants|||Number
108875|NCT00742391|Primary|Patients With Complete Clearance of Actinic Keratosis (AKs)|Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population||Participants|||Number
108876|NCT00742326|Secondary|Change in Insulin Resistance in HIV- and HCV-infected Patients With Steatosis Compared to Placebo|Change in Glucose Area Under the Curve from standard oral glucose challenge ( baseline to 2 hours): Week 48 - Baseline values|48 weeks|One subject in the placebo arm was discontinued due to health issues and does not have a 48 week OGTT available||mg*120 minutes/dL||Standard Deviation|Mean
108878|NCT00742313|Primary|Number of Participants With Decreased Bleeding|The number of participants with less than expected bleeding (bleeding typically expected for the vein grafting procedure) at the surgical site. Blood was collected in the Blake drain of the EVH wound bed treated with FloSeal MatrixFloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein.|14 days|Six participants were not analyzed due to early termination of study||participants|||Number
108879|NCT00742274|Primary|Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation|"Subjects with any of the following met this composite outcome:~partial/no false lumen thrombosis~aortic rupture~aortic dilatation~lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)"|1 year|Intent to Treat (ITT)||participants|||Number
108880|NCT00742235|Primary|Baseline 25-OH Vitamin D Level||Baseline|||ng/ml||Inter-Quartile Range|Median
108881|NCT00742235|Primary|hCAP18 Levels||Baseline|||ng/ml||Standard Deviation|Mean
108882|NCT00742209|Other Pre-specified|Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17|"Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale."|Week 17|ITT Population||Percentage of Patients|||Number
108883|NCT00742209|Other Pre-specified|Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)|Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.|Week 17|ITT Population||Hours||Standard Error|Mean
108884|NCT00742209|Other Pre-specified|Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17|The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.|Week 17|ITT Population||Points on a scale||Standard Error|Mean
108885|NCT00742209|Other Pre-specified|Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17|The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.|Baseline and Week 17|ITT Population||units on a scale||Standard Error|Mean
108886|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17|"The CGIC is a single question measured on a 7-point Likert Scale. (1 = “very much improved”; 2= much improved, and 7 = “very much worse”) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'."|Week 17|ITT Population||Participants|||Number
108887|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17|"The PGIC is a single question measured on the 7-point Likert Scale (1 = “very much improved”; 2 = much improved; 7 = “very much worse”). A responder is defined as being very much improved or much improved."|Week 17|ITT Population||participants|||Number
108888|NCT00742209|Secondary|Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods|A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.|Baseline to the Last 4 weeks of treatment|ITT Population||percentage of participants|||Number
108889|NCT00742209|Secondary|Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia|The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Percentage of MA with migraine symptoms||Standard Error|Mean
108890|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use|The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Acute Migraine Medication Doses||Standard Error|Mean
108891|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use|The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Days||Standard Error|Mean
108892|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use|The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Acute Migraine Medication Dose||Standard Error|Mean
110459|NCT00730236|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Percent change from Baseline in HDL-C|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Median
108893|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered|The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Acute Medication Doses Admin.||Standard Error|Mean
108894|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use|The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Days||Standard Error|Mean
108895|NCT00742209|Secondary|Change From Baseline in the Mean Peak Migraine Pain Severity|Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Scores on a Scale||Standard Error|Mean
108896|NCT00742209|Secondary|Change From Baseline in the Mean Migraine Attack Duration|The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Hours||Standard Error|Mean
108897|NCT00742209|Secondary|Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)|A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Migraine Headache Periods (MHP)||Standard Error|Mean
108898|NCT00742209|Secondary|Adjusted Mean Change From Baseline in the Number of Migraine Attacks|A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Migraine Attacks||Standard Error|Mean
108899|NCT00742209|Secondary|Mean Change From Baseline in the Number of MHD in All Study Phases|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population||Migraine Headache Days (MHD)||Standard Error|Mean
108900|NCT00742209|Primary|Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|Intent to treat (ITT). There were 3 subjects who were randomized but did not take investigational product, and, therefore were not included in the Safety, ITT, or Per Protocol (PP) population.||Migraine Headache Days (MHD)||Standard Error|Least Squares Mean
108901|NCT00741858|Primary|Physical Health Quality of Life|Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)|7 years|||units on a scale||Standard Error|Mean
108902|NCT00741819|Secondary|Drug Administration Activities Questionnaire|Change in tasks from Baseline to Week 12. At Baseline and Week 12, subjects provided information related to the daily administration and time requirements of inhaled iloprost (Baseline) and inhaled treprostinil (Week 12).|Baseline and 12 weeks|Subjects who completed the questionnaire at Baseline and Week 12.||minutes||Standard Deviation|Mean
108903|NCT00741819|Secondary|World Health Organization (WHO) Functional Class|Change in WHO Functional Class (FC) from Baseline to Week 12. Data presented as percent of subjects who either improved FC, worsened FC, or had no change in FC from Baseline to Week 12.|Baseline and 12 Weeks|Subjects still enrolled at Week 12 with a WHO Functional Class at Baseline and Week 12.||percentage of subjects|||Number
108904|NCT00741819|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)|Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.|Baseline and Week 12|Subjects with a NTproBNP sample drawn at Baseline and Week 12||pg/mL||Full Range|Median
108905|NCT00741819|Secondary|Patient Impression of Change|The patient impression of change (PIC) was three single therapy-related questions related to the subjects overall impression of the transition from inhaled iloprost to inhaled treprostinil. Subjects were surveyed related to their overall impression of the transition from inhaled iloprost to inhaled treprostinil at Week 12.|Baseline and 12 weeks|Subjects who completed questionnaire at Baseline and Week 12||percentage of patients|||Number
108932|NCT00741104|Secondary|Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.||||||
108906|NCT00741819|Secondary|Treatment Satisfaction Questionnaire of Medication (TSQM)|Change in TSQM score from Baseline to Week 12. The TSQM is a validated instrument (Health and Quality of Life Outcomes 2004, 2:12) that measures major dimensions of patient satisfaction with medications. The questionnaire is comprised of 15 questions which fall into one of four categories; Effectiveness, Side-Effects, Convenience, and Global Satisfaction. Responses are scaled on a seven point bipolar scale from 'Extremely Satisfied' to 'Extremely Dissatisfied' where higher scores indicate improvements (total scores from 0-100). The questionnaire was completed at Baseline and Week 12. The Baseline questionnaire focused on the subject’s satisfaction with inhaled iloprost treatment, while the questionnaire completed at Week 12 focused on the subject’s satisfaction with inhaled treprostinil.|Baseline and 12 weeks|Subjects who completed the TSQM at Baseline and Week 12. Total analysis population was less for the Convenience Score (N=67) and Global Satisfaction Score (N=66).||units on a scale||Full Range|Mean
108907|NCT00741819|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 12. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 12 weeks|Subjects who were still enrolled and completed the questionnaire at Baseline and Week 12. Total analysis population was less for the activity score and total score (N = 67).||units on a scale||Full Range|Mean
108908|NCT00741819|Secondary|Six-minute Walk Distance (6MWD)|Change in 6MWD from Baseline to Week 12. The 6-minute walk test (6MWT) was conducted at Baseline (10–30 minutes following the last dose of inhaled iloprost) and at Week 12 (10–60 minutes following the dose of inhaled treprostinil). The change in distance (meters) between Baseline and Week 12 is reported below.|Baseline and 12 weeks|Subjects enrolled at Week 12 visit.||meters||Full Range|Median
108909|NCT00741819|Primary|Number of Adverse Events|Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.|up to 24 months|All subjects who received at least one dose of inhaled treprostinil were included in the safety analysis population.||number of events|||Number
108910|NCT00741611|Secondary|Number of Participants With Acute Procedural Success in Mesh Treated Patients.|Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter|During the mesh ablation procedure|All mesh treated patients.||participants|||Number
108911|NCT00741611|Secondary|Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.|Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.|12 months|All mesh treated patients.||participants|||Number
108912|NCT00741611|Primary|Number of Participants With Freedom From Symptomatic Atrial Fibrillation|Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.|12 months|All treated patients|||||
108913|NCT00741611|Primary|Number of Participants With Serious Atrial Fibrillation Events|Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.|12 months|All treated patients.||participants|||Number
108914|NCT00741611|Primary|Number of Participants With Major Complications|A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.|12 months|Patients who were treated with the HD Mesh Ablation System||participants|||Number
108915|NCT00741468|Primary|Plasma AUC Ratio of Day 1 and Day 8|"Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition.~For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used."|8 days|One subject had concentrations of Proellex (CDB-4124 and CDB-4453) that were below the lower level of quantitation at all time points tested and was excluded from the pharmacokinetic analyses.||Ratio of geometric means Day 8 to Day 1||90% Confidence Interval|Mean
108916|NCT00741390|Secondary|Reported Device Preference Within Lancing Pair at Visit 2|"After each pair of 4 lancings, the subject was asked: Which of the two devices did you find more comfortable, overall? The choices were: first lancing, second lancing or equivalent. The Stated Preference row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The No Preference row includes lancing pairs with preference of equivalent or no answer."|Approximately Day 3 (Visit 2)|Comfort was analyzed per lancing pairs. 236 subjects performed up to 4 lancing pairs. 869 pairs were evaluated across the 4 arms. Pairs were excluded if they did not result in a valid meter reading or associated with protocol deviations or had missing comfort data.||lancing pairs|||Number
108917|NCT00741390|Secondary|Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)|"The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs.~After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second."|Approximately Day 3 (Visit 2)|61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above.||mm||Standard Deviation|Mean
110291|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|3 month after enrollment|Modified intention to treat analysis||Participants|||Number
108918|NCT00741390|Primary|Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)|In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.|Approximately Day 3 (Visit 2)|Of the 234 subjects that completed Visit 2, 229 had evaluable pairs and were included in the analysis for Visit 2. Some of the lancing pairs from several subjects were excluded due to protocol deviations, subject discontinuation or adverse events. Of these 175 subjects were analyzed for this primary outcome.||mm||Standard Deviation|Mean
108919|NCT00741390|Primary|Blood Sample of Sufficient Volume to Yield a Valid Meter Reading|Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.|Study Day 1 (Visit 1)|BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation.||Participants|||Number
108920|NCT00741338|Secondary|Percent Reduction of Urinary Glycosaminoglycan (uGAG) Level From Baseline to the End of Treatment/Early Withdrawal|Urinary Glycosaminoglycan (uGAG) Levels: concentration of glycosaminoglycan (GAG) relative to creatinine in urine. A greater decrease in uGAG level indicates a greater response.|Baseline, end of treatment/early withdrawal (up to 24 weeks after start of full-dose laronidase therapy)|Safety population included all participants who received any study drug treatment.||percent change in uGAG level||Full Range|Median
108921|NCT00741338|Primary|Number of Participants Who Achieved Immune Tolerance Induction|Immune tolerance induction success was defined as development of an anti-laronidase immunoglobulin G (IgG) antibody titer less than or equal to (<=) 1:3200 after 24 weeks of receiving full-dose (0.58 mg/kg) laronidase therapy.|24 weeks after start of full-dose laronidase therapy|Safety population included all participants who received any study drug treatment.||participants|||Number
108922|NCT00741286|Secondary|Number of Patients With First Recurrent Stroke of Any Type||90 days|||participants|||Number
108923|NCT00741286|Primary|The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study|The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling’s PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study.|14 days and 90 days from the baseline TCD study|Of the 203 patients included in the intention-to-treat analysis, 164 were included in the per-protocol analysis of the primary outcome.||ratio||Standard Deviation|Mean
108924|NCT00741273|Primary|Proellex Half-life (T1/2)|Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours|||Hours||Standard Deviation|Mean
108925|NCT00741273|Secondary|Area Under the Curve (AUC0-t) for Proellex|AUC0-t of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose.|48 hours|||ng x min/L||Standard Deviation|Mean
108926|NCT00741273|Primary|Maximum Blood Concentration (Cmax)|Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours|||ng/L||Standard Deviation|Mean
108927|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat|Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat|Baseline and after enalaprilat|||Wood units per metre squared||Full Range|Median
108928|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat||Baseline and after enalaprilat|||l/min/m2||Inter-Quartile Range|Median
108929|NCT00741104|Primary|Number of Patients Agreeing to Participate in a Dose Reduction Study|"As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study?"|Measured from the Remicade Questionnaire at first (and only) study visit|Out of the 363 subjects in the analysis, 361 subjects answered this question.||participants|||Number
108930|NCT00741104|Primary|Patient Response to Increased Dosing Interval|"Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked did you notice any difference when your dosing interval was extended? Those who noticed a difference were asked if their experience was positive or negative."|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.||participants|||Number
108931|NCT00741104|Primary|Reason for Extending Dosing Interval|Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.||participants|||Number
108933|NCT00741104|Secondary|Adverse Events (AEs)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.||||||
108934|NCT00741104|Secondary|Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.||||||
108935|NCT00741104|Primary|Dosing Interval Between the Infliximab Infusions|Patients were asked as part of the Remicade questionnaire what dosing interval they were on.|Measured from the Remicade Questionnaire at first (and only) study visit|||participants|||Number
108936|NCT00741091|Secondary|Device Malfunction|Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.|30 days|||Devices|||Number
108937|NCT00741091|Secondary|System Technical Success|System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.|30 days|To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.||Participants|||Number
108938|NCT00741091|Secondary|Target Lesion Revascularization|Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.|30 days|||Participants|||Number
108939|NCT00741091|Secondary|Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)|Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.|30 days|||Participants|||Number
108940|NCT00741091|Primary|Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)|Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).|30 days|All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.||Participants|||Number
108941|NCT00741039|Primary|Determine Response Rate of Patients > or = to 65 Yrs Diagnosed|For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).|8-16 weeks following vaccination.|||participants|||Number
108942|NCT00741026|Secondary|Diastolic Blood Pressure|Diastolic Blood Pressure|3 Days|||mmHg||Standard Error|Mean
108943|NCT00741026|Secondary|Systolic Blood Pressure|Systolic Blood Pressure|3 Days|||mmHg||Standard Error|Mean
108944|NCT00741026|Secondary|Heart Rate|Heart Rate|3 Days|||beats per minute||Standard Error|Mean
108945|NCT00741026|Secondary|BMI|BMI|3 Days|||kg / m2||Standard Error|Mean
108946|NCT00741026|Secondary|Body Weight|Body Weight|3 Days|||kg||Standard Error|Mean
108947|NCT00741026|Secondary|Total Cholesterol|Total Cholesterol|3 Days|||mg/dl||Standard Deviation|Mean
108948|NCT00741026|Secondary|LDL Cholesterol|LDL Cholesterol|3 Days|||mg/dl||Standard Deviation|Mean
108949|NCT00741026|Secondary|Triglycerides|Triglycerides|3 Days|||mg/dl||Standard Deviation|Mean
108950|NCT00741026|Secondary|HDL Cholesterol|HDL Cholesterol|3 Days|||mg/dl||Standard Deviation|Mean
108951|NCT00741026|Primary|Plasma Free Fatty Acid|Plasma Free Fatty Acid|3 Days|||mM||Standard Deviation|Mean
108952|NCT00741026|Primary|Oral Glucose Tolerance|Oral Glucose Tolerance|3 Days|||min*mg/dl||Standard Deviation|Mean
108953|NCT00741026|Primary|Plasma Leptin|Leptin following placebo or olanzapine treatment|3 Days|||ng/ml||Standard Deviation|Mean
108954|NCT00741013|Secondary|Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation|Number of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data.|24 hours after endotoxin instillation|||cells per cubic mm||Standard Deviation|Mean
108955|NCT00741013|Primary|Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation|Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment|24 hours after endotoxin instillation|||Change in Ki||Standard Deviation|Mean
108956|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Systolic Blood Pressure Response|Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure < 140 mmHg or a >= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.||Percentage of Participants|||Number
108987|NCT00740857|Secondary|Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours|SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
157648|NCT00312884|Primary|Patients Hospitalised (All Cause)||From randomisation date to 180 days|||participants|||Number
108957|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response|Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure < 90 mmHg or a >=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.||Percentage of Participants|||Number
108958|NCT00739973|Secondary|Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study|Blood pressure control defined as msSBP < 140 mm Hg and msDBP < 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.||Percentage of Participants|||Number
108959|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108960|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108961|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108962|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108963|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108988|NCT00740857|Secondary|Pain Relief (PR) Scores at Individual Time Points|"Response to the question How much pain do you have from your starting pain? was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken."|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
108964|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108965|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108966|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All randomized patients who received the study medication.||mm Hg||Standard Error|Least Squares Mean
108967|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108968|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108969|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108970|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108989|NCT00740857|Secondary|Pain Intensity Difference (PID) Scores at Each Individual Time Points|PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
108971|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108972|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108973|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108974|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108975|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108976|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108977|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
109049|NCT00739999|Secondary|Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) measured in millimoles per liter (mmol/L). Change from baseline = value at observation minus baseline value. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
108978|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108979|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108980|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108981|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108982|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.||mm Hg||Standard Error|Least Squares Mean
108983|NCT00740857|Secondary|Time to First Perceptible Relief|The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.||minutes||95% Confidence Interval|Median
108984|NCT00740857|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours|TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
108985|NCT00740857|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours|SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
108986|NCT00740857|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points|PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).||units on scale||Standard Deviation|Mean
109121|NCT00739336|Secondary|Waist Circumference||baseline, 3, 6, 12 months||||||
109122|NCT00739336|Secondary|Hemoglobin A1c|hemoglobin A1c (%)|baseline|||percent||Standard Deviation|Mean
108990|NCT00740857|Primary|Time to Meaningful Pain Relief|Subjects evaluated the time to “First Perceptible” Relief by depressing a stopwatch at the moment they first began to experience “perceptible” relief and the time to “Meaningful” Relief by depressing a second stopwatch at the moment they first began to experience “meaningful” relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.||minutes||95% Confidence Interval|Median
108991|NCT00740831|Primary|Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist|"Difference in percentage of subjects reporting moderate or severe hot flushes:~Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17."|Up to week 17|Safety population||percentage of patients|||Number
108992|NCT00740831|Primary|Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist|Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples|Week 13 visit|Safety population||log 10 (log pg/ml) E2||Standard Error|Mean
108993|NCT00740831|Secondary|Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13|"Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.~The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10)."|3 months|Per protocol||Log 10 (Log cm3) Total volume||Standard Error|Mean
108994|NCT00740831|Primary|Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|3 months|Per protocol||percentage of patients|||Number
108995|NCT00740792|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population (18 yrs of age and older) who have had one post baseline efficacy observation||units on a scale||Standard Deviation|Least Squares Mean
108996|NCT00740792|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative value is suggestive of improvement."|day 1 to14|Intent to Treat (ITT)population includes all subjects who were randomized and had at least one post baseline efficacy observation.||units on a scale||Standard Deviation|Least Squares Mean
108997|NCT00740792|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improvement."|day1 to 14 days|Intent-to-Treat(ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation||units on a scale||Standard Deviation|Least Squares Mean
108998|NCT00740779|Primary|National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.|Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||Units on a 0 to 43 scale||Standard Deviation|Mean
108999|NCT00740727|Secondary|Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up|"Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.~Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back)."|2 days|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
109000|NCT00740727|Secondary|Number of Participants With Pain During EASI Infusion|Assessment during EASI placement & initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
109022|NCT00740714|Secondary|Change in PD Quality of Life Scale From Baseline to 16 Months|The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
109001|NCT00740727|Primary|Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose|Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
109002|NCT00740727|Primary|Number of Participants With Successfully Placed EASI Lines|"Ability of Basic Life Support (BLS) providers to place EASI access lines.~The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed)."|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.||Participants|||Number
109003|NCT00740714|Secondary|Adverse Experiences: Insomnia: Moderate/Severe|Number of participants with moderate/severe insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109004|NCT00740714|Secondary|Adverse Experiences: Back Pain: Moderate/Severe|Number of participants with moderate/severe back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109005|NCT00740714|Secondary|Adverse Experiences: Anxiety: Moderate/Severe|Number of participants with moderate/severe anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109006|NCT00740714|Secondary|Adverse Experiences: Constipation: Moderate/Severe|Number of participants with moderate/severe constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109007|NCT00740714|Secondary|Adverse Experiences: Depression|Number of participants with depression|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109008|NCT00740714|Secondary|Adverse Experiences: Hypertension|Number of participants with hypertension|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109009|NCT00740714|Secondary|Adverse Experiences: Nausea|Number of participants with nausea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109010|NCT00740714|Secondary|Adverse Experiences: Urinary Tract Infection|Number of patients with urinary tract infections|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109011|NCT00740714|Secondary|Adverse Experiences: Headache|Number of participants with headache|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109012|NCT00740714|Secondary|Adverse Experiences: Diarrhoea|Number of participants with diarrhoea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109013|NCT00740714|Secondary|Adverse Experiences: Nasopharyngitis|Number of participants with nasopharyngitis|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109014|NCT00740714|Secondary|Adverse Experiences: Tremor|Number of participants with tremor|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109015|NCT00740714|Secondary|Adverse Experiences: Anxiety|Number of participants with anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109016|NCT00740714|Secondary|Adverse Experiences: Insomnia|Number of participants with insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109017|NCT00740714|Secondary|Adverse Experiences: Constipation|Number of participants with constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109018|NCT00740714|Secondary|Adverse Experiences: Back Pain|Number of participants with back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.||participants|||Number
109019|NCT00740714|Secondary|CoQ10 Levels in Plasma|Based on samples analyzed to date|Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants have been included and data is based on samples analyzed to date.||ug/ml||Standard Deviation|Mean
109020|NCT00740714|Secondary|Change in Hoehn & Yahr Score From Baseline to 16 Months|The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
109021|NCT00740714|Secondary|Change in Symbol Digit Modalities Test From Baseline to 16 Months|The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
109123|NCT00739336|Secondary|Fasting Lipid Profile|LDL-cholesterol (mg/dL)|Baseline|||mg/dL||Standard Deviation|Mean
109124|NCT00739336|Secondary|Fasting Glucose Level|Fasting glucose (mg/dL)|Baseline|||mg/dL||Standard Deviation|Mean
109023|NCT00740714|Secondary|Change in Modified Rankin Scale From Baseline to 16 Months|The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
109024|NCT00740714|Secondary|Change in Modified Schwab & England Independence Scale From Baseline to 16 Months|This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.||units on a scale||Standard Error|Least Squares Mean
109025|NCT00740714|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|Eligible research participants were assigned by randomization to one of three treatment groups: CoQ10 2400 mg/day, CoQ10 1200 mg/day or matching placebo. All participants also received 1200 IU of vitamin E daily.||units on a scale||Standard Error|Least Squares Mean
109026|NCT00740636|Primary|The Objective Overall Response|"The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years|||participants|||Number
109027|NCT00740597|Primary|Wound Complication Rate|"Major wound complications up to 4 months post surgery include:~Complications requiring a secondary operation under general or regional anesthesia for wound care.~Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days."|1 year|The one patient accrued to the study stopped treatment prior to completing treatment due to insurance denial.|||||
109028|NCT00740584|Secondary|Incidence of Adverse Experiences||Approximately 13 weeks||||||
109029|NCT00740584|Primary|HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)|"The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture.~The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has."|at 3 hours|||percent anti-viral activity||Inter-Quartile Range|Median
109030|NCT00740480|Secondary|Tissue Reaction to Implant|None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.|One week post surgery|ITT||participants|||Number
109031|NCT00740480|Primary|Coaptation (Tissue Approximation)|Complete tissue approximation at one week.|One week post surgery|ITT||participants|||Number
109032|NCT00740220|Primary|Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)|The kappa statistic is a measure of the quality of a test. It is a ratio.|All three 6MWTs should take place within 30 days|||Ratio|||Number
109033|NCT00740207|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose|||Participants|||Number
109034|NCT00740207|Secondary|The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.|Immediately postdose|Patients who did not deviate from the planned protocol.||Participants|||Number
109035|NCT00740207|Primary|Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.|Immediately prior to power injection run and again immediately following power injection run|Patients who did not deviate from the planned protocol.||Participants|||Number
109036|NCT00740181|Primary|Response Rate|"Complete Response/Complete Remission:~Complete remission (CR) is defined as the presence of all of the following:~Peripheral blood - No leukemic blasts present.~No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)~Bone marrow~No Auer rods~Less than 5% blast cells.~CBC and bone marrow criteria must be met within one week of each other.~Hemoglobin 9g/dl or greater~Neutrophil count >1000 and platelet count >100,000.~RBC Transfusion free for 2 weeks."|within 30 days of last treatment|||participants|||Number
109037|NCT00740051|Secondary|The Change in FPG From Baseline by Visit Over Time|This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.|Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)||mg/dL||Standard Deviation|Mean
109038|NCT00740051|Secondary|The Change in HbA1c From Baseline by Visit Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.|Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)||percent||Standard Deviation|Mean
109039|NCT00740051|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders.||percent of patients|||Number
109040|NCT00740051|Secondary|Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|FAS patients with baseline HbA1c >= 6.5%. Patients without a value at Week 18 were analysed as non-responders.||percent of patients|||Number
109041|NCT00740051|Secondary|Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|Full Analysis Set (FAS) patients with baseline HbA1c >= 7.0%. Patients without a value at week 18 were analysed as non-responders.||percent of patients|||Number
109042|NCT00740051|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).|Baseline and week 18|All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis).||mg/dl||Standard Error|Mean
109043|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Final Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Mean
109044|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Interim Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule.||percent||Standard Error|Mean
109045|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)|Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.||liters||95% Confidence Interval|Number
109046|NCT00739999|Secondary|Percent Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial Flow-Mediated Dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.||percent change in FMD||Standard Deviation|Mean
109047|NCT00739999|Secondary|Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial artery flow-mediated dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. Standardized image acquisition: brachial artery images recorded for one minute at rest, blood pressure cuff inflated to 250 mm Hg for 5 minutes with brachial artery imaged continuously throughout cuff inflation, cuff released to produce reactive hyperaemia and the brachial artery imaged continuously for 3 minutes after release. Total duration of measurement approximately 25 minutes. Change from baseline = value at observation minus baseline value.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.||FMD||Standard Deviation|Mean
109048|NCT00739999|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Very low-density lipoprotein-cholesterol (VLDL-C): percent (%) change from baseline by treatment over time = [VLDL-C at observation minus VLDL-C at Week 0] divided by VLDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in VLDL-C||Standard Deviation|Mean
109125|NCT00739336|Primary|Body Weight|Weight loss in kg|3 months|"Participants from the wait-list Control Arm have been combined in the Intervention Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis."||kg||95% Confidence Interval|Mean
109050|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apolipoprotein B (Apo B): percent (%) change from baseline by treatment over time = [Apo B at observation minus Apo B at Week 0] divided by Apo B at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in Apo B||Standard Deviation|Mean
109051|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein B (Apo B)|Change from baseline in Apolipoprotein B measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||g/L||Standard Deviation|Mean
109052|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Apolipoprotein A-1 (Apo A-1): percent (%) change from baseline by treatment over time = [Apo A-1 at observation minus Apo A-1 at Week 0] divided by Apo A-1 at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in Apo A-1||Standard Deviation|Mean
109053|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Change from baseline in Apolipoprotein A-1 measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||g/L||Standard Deviation|Mean
109054|NCT00739999|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|High-density lipoprotein cholesterol (HDL-C): percent (%) change by treatment over time = [HDL-C at observation minus HDL-C at Week 0] divided by HDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in HDL-C||Standard Deviation|Mean
109055|NCT00739999|Secondary|Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|Change from baseline in high-density lipoprotein cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
109056|NCT00739999|Secondary|Percent Change From Baseline in Triglycerides (TG)|Triglycerides (TG): percent (%) change from baseline by treatment over time = [TG at observation minus TG at Week 0] divided by TG at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in TG||Standard Deviation|Mean
109057|NCT00739999|Secondary|Absolute Change From Baseline in Triglycerides (TG)|Change from baseline in triglycerides measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
109058|NCT00739999|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Total cholesterol (TC): percent (%) change from baseline by treatment over time = [TC at observation minus TC at Week 0] divided by TC at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in TC||Standard Deviation|Mean
109059|NCT00739999|Secondary|Absolute Change From Baseline in Total Cholesterol (TC)|Total Cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||mmol/L||Standard Deviation|Mean
109060|NCT00739999|Secondary|Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density Lipoprotein Cholesterol (LDL-C): percent (%) change from baseline by treatment over time = [LDL-C at observation minus LDL-C at Week 0] divided by LDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population||percent change in LDL-C||Standard Deviation|Mean
109061|NCT00739999|Secondary|Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density lipoprotein cholesterol (LDL-C) measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|Pharmacodynamic (PD) analysis population: all enrolled subjects who received ≥ 1 dose of study drug and had ≥ 1 PD parameter measurement.||mmol/L||Standard Deviation|Mean
109062|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)|Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.||L/hr|||Number
109063|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
109064|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
109126|NCT00739310|Primary|Hospitalizations Lasting at Least 24 Hours in This Patient Population|Hospitalizations lasting at least 24 hours|end of study|||hospitalizations|||Number
109065|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
109066|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N=number of participants with analyzable data.||hours||Full Range|Median
109067|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
109068|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
109069|NCT00739934|Secondary|Trough Concentrations (Cmin)||Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.||μg/mL||Standard Deviation|Geometric Mean
109070|NCT00739934|Secondary|Tmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
109071|NCT00739934|Secondary|Cmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
109072|NCT00739934|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
109073|NCT00739934|Primary|Tmax Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
109074|NCT00739934|Primary|Cmax,ss Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
109075|NCT00739934|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
109076|NCT00739934|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
109077|NCT00739934|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
109078|NCT00739934|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|Intent-to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
109079|NCT00739908|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|CGI-S measures the study rater's assessment of the severity of depression illness. CGI-S is rated on a scale of 1-7 as follows: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill patients. CGI-S was measured at randomization and Weeks 1, 2, 4 and 6. Percentage of subjects reported as normal, not at all ill; borderline mentally ill; and mildly ill is reported here at Week 6 or the last available post treatment result (LOCF).|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||Percentage of Participants|||Number
109080|NCT00739908|Secondary|Clinical Global Impression - Improvement of Illness (CGI-I)|"The Clinical Global Impression - Improvement of Illness (CGI-I) was rated on a 7-point scale by the investigator to measure subject’s total improvement compared to his/her condition at randomization according to the following scale: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I was measured at Weeks 1, 2, 4 and 6. Percentage of participants very much improved and much improved at Week 6 or the last available post treatment result (LOCF) is reported here."|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||Percentage of Participants|||Number
109081|NCT00739908|Secondary|Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)|IDSR-SR 30 measures the severity of depressive symptoms by subjects. This scale has 30 items. The minimum score is 0 and the maximum possible IDS-30 score is 90 (the highest severity). IDS-SR30 was administered at screening, randomization and Weeks 1, 2, 4, and 6. Change from randomization in the IDS-SR30 total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||units on a scale||95% Confidence Interval|Least Squares Mean
109082|NCT00739908|Secondary|The Hospital Anxiety and Depression Scale (HADS)|HADS is a subject-rated questionnaire designed to detect states of anxiety and depression. The HADS consists of 14 questions relating to anxiety or depression, each with a choice of four responses [Zigmond, 1983]. These responses are numerically scored 0-3, with 0 representing the least severe response and 3 representing the most severe response. The highest possible total score is 42. HADS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. Change from randomization in the HADS total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||units on a scale||95% Confidence Interval|Least Squares Mean
109083|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate|Percentage of participants with total MADRS score of 11 or less. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Remitter rate at Week 6 or the last available post treatment result (LOCF)is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.||Percentage of Participants||95% Confidence Interval|Number
109084|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate|MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. Percentage of participants who achieved a reduction in total MADRS score of at least 50% or more as compared to baseline. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Responder rate at Week 6 or the last available post treatment result (LOCF) is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomization MADRS score.||percentage of participants||95% Confidence Interval|Number
109085|NCT00739908|Primary|Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.|Randomization and study end (Week 6).|mITT population consisted of all patients with at least one post randomzation MADRS score. The primary efficacy variable was the change-from-randomization to each available post-randomization measurement of the MADRS total score, used as the response variable in a mixed model repeated measures (MMRM) analysis.||units on a scale||95% Confidence Interval|Least Squares Mean
109086|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
109087|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
109088|NCT00739882|Secondary|Proportion of Participants From the Initial Placebo Group Achieving a PGA – H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
109089|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24|"The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
109090|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
109091|NCT00739882|Primary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA – H&F) Rating Of Clear, Almost Clear Or Mild At Week 12|"The proportion of subjects achieving a PGA – H&F rating of clear, almost clear, or mild at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed|||||
109140|NCT00739102|Secondary|Index Limb Amputation at 30-day Follow up|Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.|30 day|Active subjects in the Modified ITT population at 30 days post procedure||participants|||Number
109092|NCT00739765|Secondary|Hamilton Depression Rating Scale|Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores <8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62|After 14 weeks of treatment|||units on a scale||Standard Deviation|Mean
109093|NCT00739765|Primary|Clinician-Administered PTSD Scale (CAPS)|Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores >50 indicate at least moderately severe PTSD; scores <20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75–90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156|After 14 weeks of treatment|||units on a scale||Standard Deviation|Mean
109094|NCT00739674|Secondary|Time to Achieve the Target Blood Pressure From Baseline|Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 437 and 386 patients for L group and DML group respectively.||Weeks||95% Confidence Interval|Median
109095|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
109096|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
109097|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
109098|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
109099|NCT00739674|Primary|Change in Diastolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
109100|NCT00739674|Primary|Change in Systolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.||mm Hg||Standard Deviation|Mean
109101|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment|40 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively.||Participants|||Number
109102|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment|10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.||Participants|||Number
109103|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment|6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.||Participants|||Number
109104|NCT00739674|Primary|Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.||Participants|||Number
109105|NCT00739661|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death by any cause.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.||Months||Standard Deviation|Mean
109106|NCT00739661|Secondary|Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression|Hedgehog antigen expression was measured with immunohistochemical methods in tumor tissue taken from each patient prior to enrollment in the study. The percentage of cells with (> 0%) and without (0%) Hedgehog antigen expression was measured microscopically. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 29 patients in the vismodegib group and 28 patients in the placebo group.||Months||95% Confidence Interval|Median
109141|NCT00739102|Secondary|Death at 12-month Post Procedure||12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
109142|NCT00739102|Secondary|Death Rate at 30-day Post Procedure||30 days|Active subjects in the Modified ITT population at 30-day post procedure||participants|||Number
109107|NCT00739661|Primary|Progression-free Survival (PFS)|PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.||Months||95% Confidence Interval|Median
109108|NCT00739648|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|The percent change in the amount of air a patient can exhale in 1 second|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT||Percent||Standard Error|Least Squares Mean
109109|NCT00739648|Secondary|Percent Change in Forced Vital Capacity (FVC)|The percent change in the amount of air a patient can inhale|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT||Percent||Standard Error|Least Squares Mean
109110|NCT00739648|Secondary|Duration of Acute Exacerbation|From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation|from randomization to the patient's final study visit (up to 12 months)|MITT||Days||Standard Deviation|Mean
109111|NCT00739648|Primary|Exacerbation Rate|The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.|From randomization to the patients final study visit (up to 12 months)|modified intent to treat (MITT; patients who received at least one dose of study drug)||exacerbation per patient year||Standard Error|Mean
109112|NCT00739596|Secondary|Percentage of Participants Achieving BP Control After 8 Weeks of Treatment|To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.||Cumulative percentage of participants|||Number
109113|NCT00739596|Secondary|Percentage of Responders After 8 Weeks of Treatment.|To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.]|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.||Cumulative percentage of responders|||Number
109114|NCT00739596|Secondary|Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment|To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.||mm Hg||Standard Deviation|Mean
109115|NCT00739596|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment|To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.||mm Hg||Standard Deviation|Mean
109116|NCT00739596|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment|To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.||mm Hg||Standard Deviation|Mean
109117|NCT00739583|Secondary|Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification|The number of sets of initials judged by the viewing orthopedic surgeons as sufficient for adequate site identification. Each participant was labeled with three initials to simulate a surgeon's initials. Ten orthopaedic surgeons determined if the initials were visible enough to allow for site identification. Each surgeon viewed all of the sets of initials, resulting in 100 viewed sets of initials in each group.|at time of surgery, approximately ten minutes|||sets of intials|Participants||Number
109118|NCT00739583|Secondary|The Mean Change in Gray Level (Contrast) of the Horizontal Line|The Mean change in gray level of the ink line as expressed in units between pre and post skin preparation. Gray level is a unitless value from 0-255 describing the brightness of a pixel (0 being black and 255 being white).|at time of surgery, approximately ten minutes|||gray level units|Participants|Standard Deviation|Mean
109119|NCT00739583|Primary|Identification of the Random Initials by the Reviewing Orthopaedic Surgeons|The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.|at time of surgery, approximately 10 minutes|||number of correctly identified initals|Participants||Number
109120|NCT00739336|Secondary|Questionnaires||baseline, 3, 6, 12 months||||||
109127|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.|0 (baseline) and 24 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L||95% Confidence Interval|Least Squares Mean
109128|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.|0 (baseline) and 8 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L||95% Confidence Interval|Least Squares Mean
109129|NCT00739297|Secondary|Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration|FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (albuterol or matching placebo) 4 hours after treatment with montelukast at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L||95% Confidence Interval|Least Squares Mean
109130|NCT00739297|Primary|Change From Baseline in FEV1 Over 4 Hours|FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|0 (=baseline) to 4 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.||L (Liter)||95% Confidence Interval|Least Squares Mean
109131|NCT00739102|Secondary|Major Adverse Events at 12-month Post Procedure|Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
109132|NCT00739102|Secondary|Rutherford / Becker Classification Category at 12-month Follow Up||12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
109133|NCT00739102|Secondary|Rutherford/Becker Classification at 30-day Follow Up|"The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:~Stage 0 – Asymptomatic, no hemodynamically significant occlusive disease~Stage 1 – Mild claudication~Stage 2 – Moderate claudication~Stage 3 – Severe claudication~Stage 4 – Ischemic rest pain~Stage 5 – Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia~Stage 6 – Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|30 days|Active subjects in the Modified ITT population at 30-day post procedure||participants|||Number
109134|NCT00739102|Secondary|Index Limb Ischemia at 12-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
109135|NCT00739102|Primary|Primary Safety Endpoint|Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30 days post procedure||participants|||Number
109136|NCT00739102|Secondary|Index Limb Ischemia at 6-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|6 months|Active subjects in the Modified ITT population at 6-month post procedure||participants|||Number
109137|NCT00739102|Secondary|Stent Fracture at 12-month Follow Up|Stent fracture was assessed by x-ray evaluation.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
109138|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|12 months|Active subjects in the Modified ITT population at 12-month post procedure||participants|||Number
109139|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30-day post procedure||participants|||Number
110460|NCT00730236|Secondary|Percent Change From Baseline in Triglycerides|Percent change from Baseline in triglycerides|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
109143|NCT00739102|Primary|12-month Primary Patency Rate|Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.|12 months|As a subset of the modified ITT, this analysis population consisted of the subjects who had ultrasound assessment at 12 months or had target vessel revascularization (TVR) performed by 12 months.||participants|||Number
109144|NCT00739063|Primary|Time to Progression (TTP)|Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.|Baseline to disease progression, up to 22 months with follow up.|Study terminated early, unable to complete overall analysis due to insufficient data.||months|||Number
109145|NCT00739050|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
109146|NCT00739050|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
109147|NCT00739050|Secondary|Change in Total Cholesterol From Baseline at Week 12|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
109148|NCT00739050|Primary|Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.|||||
109149|NCT00739024|Primary|T-Test|It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.|4 weeks||||||
109150|NCT00738972|Primary|Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients|Left ventricular hypertrophy reduction was to be measured by echocardiography.|6 Month(s)|This study was terminated early and due to sample size it was not possible to perform further statistical analyses.|||||
109151|NCT00738881|Secondary|Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)|Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher’s exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT.|Up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.|||||
109152|NCT00738881|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.|Time from randomization to time of death from any cause, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.|||||
109153|NCT00738881|Secondary|Time to Treatment Failure|The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves.|The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.|||||
109154|NCT00738881|Primary|Progression-free Survival (PFS)|Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.|Time from randomization to the first date of documented disease progression or death, assessed up to 5 years|All the 23 randomized patients are eligible for primary end point analysis using an ITT principle.||months||95% Confidence Interval|Median
109155|NCT00738673|Secondary|Kaplan-Meier Estimate for Overall Survival|The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient’s data were censored at the date of last visit.|up to month 12|"Intent to treat population.~Analysis was not performed since no participants died during study."|||||
109156|NCT00738673|Secondary|Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study|Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.|up to month 12|Intent to treat population||participants|||Number
109157|NCT00738673|Secondary|Participants at Testosterone Level <=0.32 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.||participants|||Number
110461|NCT00730236|Secondary|Percent Change From Baseline for Apolipoprotein B (Apo B)|Percent change from Baseline for Apo B|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
109164|NCT00738673|Secondary|Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the two month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 2 months|Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.||percentage of participants||95% Confidence Interval|Number
109165|NCT00738673|Secondary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the one month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 1 month|Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.||percentage of participants||95% Confidence Interval|Number
109166|NCT00738673|Primary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level"|Day 0 (baseline), 3 months|Intent to treat population. Last observation carried forward.||percentage of participants||95% Confidence Interval|Number
109167|NCT00738543|Secondary|Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period|Presence of allergy or skin reaction at 24 hours after the application of the antiseptic|24 hours|||Number of participants with reaction|||Number
109168|NCT00738543|Primary|Bacterial Colony Forming Units for the Control Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours|||Colony-forming units per cm squared||Inter-Quartile Range|Median
109169|NCT00738543|Primary|Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours|||Colony-forming units per cm squared||Inter-Quartile Range|Median
109170|NCT00738543|Secondary|Presence of Skin Reactions for the 10% Povidone-iodine Period|Presence of allergy or any skin reaction at 24 hours after the antiseptic application|24 hours|A minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL, with a power of 80%, and bilateral error of 5%. Analysis per protocol.||Number of participants with skin reactio|||Number
109171|NCT00738543|Primary|Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period|Bacterial colony count of skin cultures to determine antiseptic properties|24 hours|||Colony-forming units per cm squared||Inter-Quartile Range|Median
109172|NCT00738530|Secondary|Change From Baseline in Karnofsky Performance Status|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Week 7, 15, 23, 31, 43|Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.||score on a scale||Full Range|Median
109173|NCT00738530|Secondary|Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to mRECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >=30% decrease under baseline of the sum of the LD of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.||percentage of participants|||Number
109174|NCT00738530|Secondary|Percentage of Participants With Objective Response According to mRECIST|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.||percentage of participants|||Number
109186|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8|Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent successful erections||95% Confidence Interval|Least Squares Mean
109187|NCT00738400|Secondary|"Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)"|Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')|up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.||Percentage of participants|||Number
109175|NCT00738530|Secondary|Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to treatment failure was defined as the time between the date of randomization and the date of insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last tumor assessment or last treatment administration, whichever occurred last. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
109176|NCT00738530|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||percentage of participants|||Number
109177|NCT00738530|Secondary|Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to progression was defined as the time between date of randomization and date of documented progression. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event (including participants who died before progressive disease) were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
109178|NCT00738530|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST. Progressive disease was defined as at least a 20 percentage(%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
109179|NCT00738530|Secondary|Percentage of Participants With Disease Progression or Death|Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.||percentage of participants|||Number
109180|NCT00738530|Primary|Overall Survival (OS) Duration|Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.|Baseline until death (up to 4.25 years)|ITT population included all participants randomized into the study.||months||95% Confidence Interval|Median
109181|NCT00738530|Primary|Percentage of Participants Who Died||Baseline up to 4.25 years|ITT population included all participants randomized into the study.||percentage of participants|||Number
109182|NCT00738426|Secondary|Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ).||4 weeks||||||
109183|NCT00738426|Primary|Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.||2 weeks|||participants|||Number
109184|NCT00738400|Secondary|Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))|Number of participants with no recorded titration of Vardenafil after visit 3.|week 4 and week 8|||Participants|||Number
109185|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8|Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent successful ejaculations||95% Confidence Interval|Least Squares Mean
109387|NCT00736996|Secondary|Change in Insulin Resistance|Change in whole body glucose disposal rate (mg/kg/min) calculated during a single-stage (40 mU/m2/min), 3-hour hyperinsulinemic, euglycemic clamp|Baseline to 6 months|||mg/kg/min||95% Confidence Interval|Number
109188|NCT00738400|Primary|Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8|Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent erection maintenance||95% Confidence Interval|Least Squares Mean
109189|NCT00738400|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8|Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.||Percent successful penetrations||95% Confidence Interval|Least Squares Mean
109190|NCT00738400|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)|The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.|baseline and up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.||Scores on a scale||95% Confidence Interval|Least Squares Mean
109191|NCT00738374|Secondary|Disease-Free Survival|The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. In both groups, the mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.||days||Standard Error|Mean
109192|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR/CRi|Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants with a confirmed CR or CRi were included in the analysis.||participants|||Number
109193|NCT00738374|Secondary|Duration of Response|The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.||days||Standard Error|Mean
109194|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR, CRi, or PR|Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.||participants|||Number
109195|NCT00738374|Secondary|OS|The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||Standard Error|Mean
109196|NCT00738374|Secondary|Number of Participants Who Died|Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
109197|NCT00738374|Secondary|Time to Next Treatment (TTNT)|The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||Standard Error|Mean
109198|NCT00738374|Secondary|Number of Participants With New CLL Treatment or Death|Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
109236|NCT00737711|Secondary|Mean Serum Phosphate Over Time|Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
109199|NCT00738374|Secondary|PFS|The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death. CR and PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||95% Confidence Interval|Median
109200|NCT00738374|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death. PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
109201|NCT00738374|Secondary|EFS|The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose if study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||days||95% Confidence Interval|Median
109202|NCT00738374|Secondary|Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment|Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose of study treatment.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population||participants|||Number
109203|NCT00738374|Secondary|Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study|Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants analyzed for the given parameter at the specified timepoint.||percentage of participants|||Number
109204|NCT00738374|Secondary|Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study|Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants, only participants with a confirmed CR were included in the analysis.||percentage of participants|||Number
109205|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study|CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined.|Month 35|All randomized participants.||percentage of participants|||Number
109206|NCT00738374|Secondary|Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment|Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 10|ITT population||participants|||Number
109207|NCT00738374|Secondary|Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study|CR, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 35|All randomized participants who were assessed at Month 35 were included in the analysis.||percentage of participants|||Number
109208|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment|CR, CRi, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 10|ITT population||percentage of participants|||Number
109237|NCT00737711|Secondary|Mean Serum Sodium Over Time|Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mmol/L||Standard Deviation|Mean
109534|NCT00736099|Secondary|Change in FPG From Baseline to Week 78||Baseline and week 78|Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
109209|NCT00738374|Secondary|Percentage of Participants With Documented CR, CRi, or PR at the End of Study|CR defined as: 1) laboratory CR: PBL <4000/μL, PMN > 1500/μL, platelets > 100,000/μL, and Hb > 11 g/dL; 2) clinical CR: LN < 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN < 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age < 30% lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN > 1500/μL, platelets > 100,000/μL or > 50% improvement from BL, and Hb >11.0 g/dL or > 50% improvement from BL.|Month 35|All randomized participants.||percentage of participants||95% Confidence Interval|Number
109210|NCT00738374|Primary|Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment|CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (<) 4000/microliter (μL), neutrophils (PMN) greater than (>) 1500/μL, platelets >100,000/μL, and hemoglobin (Hb) >11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) <1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN <1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age <30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN >1500/μL, platelets >100,000/μL or >50% improvement from BL, and Hb >11.0 g/dL or >50% improvement from BL.|Month 10|Intent to treat (ITT) population: all consented participants who received at least 1 dose of rituximab.||percentage of participants||95% Confidence Interval|Number
109211|NCT00738361|Secondary|Overall Survival|Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.|up to 1 year following last treatment, for a total of approximately 5 years|||months||Standard Error|Mean
109212|NCT00738361|Secondary|Progression-free Survival|Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel|up to 1 year following last treatment, for a total of approximately 5 years|all patients progressed at the time of first scan||months||95% Confidence Interval|Median
109213|NCT00738361|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 1 year following last treatment, for a total of approximately 5 years|||patients|||Number
109214|NCT00738283|Primary|Zinc Absorption|"Zinc fractional absorption was measured using a dual tracer stable isotope method in which 67Zn was given orally with a single feed followed immediately by infusion of 70Zn intravenously. A spot urine sample was collected 96 hours after the infusion and the relative dose-corrected enrichments used to calculate fractional absorption at the time oral isotope was administered.~Tracer:tracee ratios (TTR), measured by ICP-MS, were used to calculated fractional zinc absorption."|96 hours after single feed infusion|Relationships between zinc absorption, zinc excretion (urine or fecal) and zinc balance, and potential explanatory variables were analyzed using the GLM model function of JMP 7 for Macintosh (SAS inc, Cary, NC). Simple and multiple regression analysis were used as appropriate. Significance was assumed at a p < 0.05.||fractional zinc absorption (%)||Standard Deviation|Mean
109215|NCT00738062|Secondary|Clinician Rated Clinical Global Impressions - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days|||participants|||Number
109216|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days|||participants|||Number
109217|NCT00738062|Secondary|Clinician Recorded Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7)."|14 days|||participants|||Number
109218|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7). ."|14 days|||participants|||Number
109219|NCT00738062|Post-Hoc|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients were on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days|||units on a scale||Standard Deviation|Mean
109220|NCT00738062|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days|||mmHg||Standard Deviation|Mean
109284|NCT00737568|Secondary|Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
109221|NCT00738062|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score|"The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days|||units on a scale||Standard Deviation|Mean
109222|NCT00738062|Secondary|Change in Orthostatic Hypotension Daily Activities (OHDAS) Score|"The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days|One droxidopa patient excluded from analysis because data were not evaluable.||units on a scale||Standard Deviation|Mean
109223|NCT00738062|Primary|Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization."|14 days|"The analysis population was based on the ITT population of all patients randomized. Last observation carry forward was used for patients who prematurely discontinued the study.~One droxidopa patient was excluded from the analysis because OHQ values were not evaluable."||units on a scale||Standard Deviation|Mean
109224|NCT00738049|Secondary|Change During Darusentan Treatment in the Coronary Flow Reserve (CFR)|CFR is calculated as the unitless ratio between hyperemic to resting flow|0, 2, 4, and 6 weeks|||no units||Standard Deviation|Mean
109225|NCT00738049|Secondary|Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia||0, 2, 4, and 6 weeks|||cc/min/gm||Standard Deviation|Mean
109226|NCT00738049|Primary|Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity|Markovian homogeneity analysis characterizes an image produced by a PET scan by examining the probability that a pixel with a given intensity will have a neighbor with a different intensity. The homogeneity index ranges from >0 to 1, where a value near 0 represents an image with a high probability that neighboring pixels have intensity values that differ greatly, and a value near 1 represents an image with a high probability that neighboring pixels have similar intensity values.|0, 2, 4, and 6 weeks|Statistical analysis is exploratory, therefore not easily planned. A paired t-test with 40 subjects will provide approximately 89% power to test the null hypothesis of no change in the homogeneity number versus a two-sided alternative at alpha= 5%,if the true mean change is 0.15,e.g.,a homogeneity index of 0.5 at baseline and 0.65 after darusentan.||No units||Standard Deviation|Mean
109227|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention|Systolic blood pressure change from baseline during an 48-hour intralipid infusion after taking rosiglitazone for 6 weeks in obese diabetic subjects|48 hours|||mmHg||Standard Error|Mean
109228|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Saline Infusions|Systolic blood pressure change from baseline during an 48-hour normal saline infusion in obese diabetic subjects|48 hours|||mmHg||Standard Error|Mean
109229|NCT00738023|Primary|Changes in Systolic Blood Pressure During Initial Intralipid Infusion|Systolic blood pressure change from baseline during an 48-hour intralipid infusion|Baseline, 48 hours|||mmHg||Standard Error|Mean
109230|NCT00737737|Secondary|Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?||4 weeks|||ng/ml|||Number
109231|NCT00737737|Primary|Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?||4 weeks|||ng/ml|||Number
109232|NCT00737711|Secondary|Mean Serum Alkaline Phosphatase Over Time|Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||U/L||Standard Deviation|Mean
109233|NCT00737711|Secondary|Mean Alanine Aminotransferase Over Time|Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||U/L||Standard Deviation|Mean
109234|NCT00737711|Secondary|Mean Aspartate Transaminase Over Time|Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Units/Liter (U/L)||Standard Deviation|Mean
109235|NCT00737711|Secondary|Mean Serum Bilirubin Over Time|Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
109238|NCT00737711|Secondary|Mean Serum Potassium Over Time|Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||millimoles per liter (mmol/L)||Standard Deviation|Mean
109239|NCT00737711|Secondary|Mean Blood Urea Nitrogen Over Time|Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
109240|NCT00737711|Secondary|Mean Serum Creatinine Over Time|Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mg/dL||Standard Deviation|Mean
109241|NCT00737711|Secondary|Mean Serum Globulin Over Time|Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||g/dL||Standard Deviation|Mean
109242|NCT00737711|Secondary|Mean Serum Albumin Over Time|Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||g/dL||Standard Deviation|Mean
109243|NCT00737711|Secondary|Mean Transferrin Saturation Over Time|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Percentage of transferrin saturation||Standard Deviation|Mean
109244|NCT00737711|Secondary|Mean Total Iron-binding Capacity Over Time|Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||mcg/dL||Standard Deviation|Mean
109245|NCT00737711|Secondary|Mean Transferrin Over Time|Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
109246|NCT00737711|Secondary|Mean Serum Ferritin Over Time|Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||nanogram /milliliter (ng/mL)||Standard Deviation|Mean
109247|NCT00737711|Secondary|Mean Serum Iron Over Time|Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||microgram/deciliter (mcg/dL)||Standard Deviation|Mean
109248|NCT00737711|Secondary|Mean Platelet Count Over Time|Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||cells per cubic millimeter||Standard Deviation|Mean
109249|NCT00737711|Secondary|Mean Hypochromic Red Blood Cells Over Time|Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||cells per cubic millimeter||Standard Deviation|Mean
109250|NCT00737711|Secondary|Mean Value of Mean Corpuscular Volume Over Time|Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Femtoliter||Standard Deviation|Mean
109535|NCT00736099|Secondary|Change in FPG From Baseline to Week 66||Baseline and week 66|Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
109251|NCT00737711|Secondary|Mean White Blood Cell Count Over Time|The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||cells per cubic millimeter||Standard Deviation|Mean
109252|NCT00737711|Secondary|Number of Participants With Reports of Anti-Epoetin Antibodies|Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug.||Participants|||Number
109253|NCT00737711|Secondary|Number of Participants With Reports of Blood Transfusions|Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.||Participants|||Number
109254|NCT00737711|Secondary|Number of Participants With Abnormal Electrocardiogram|Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.|Up to Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.||Participants|||Number
109255|NCT00737711|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 18|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.||Participants|||Number
109256|NCT00737711|Secondary|Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug.||percentage of participants||95% Confidence Interval|Number
109257|NCT00737711|Secondary|Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10–12 g/dL) during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.||Weeks||Standard Deviation|Mean
109258|NCT00737711|Secondary|Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter|Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.|Up to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.||Weeks||Standard Deviation|Mean
109259|NCT00737711|Primary|Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period|The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.|Baseline (Week 0) and Week 16|The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.||gram/deciliter (g/dL)||Standard Deviation|Mean
109260|NCT00737672|Secondary|Procedural Success|Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.|Following Index Procedure|||Participants|||Number
109261|NCT00737672|Secondary|Anatomic Success|Less than 30 percent residual stenosis following study treatment (Index Procedure).|Index Procedure|||Participants|||Number
109262|NCT00737672|Secondary|Clinical Success|The resumption of normal dialysis for at least one session following study treatment (Index Procedure).|Following Index Procedure|||Participants|||Number
109263|NCT00737672|Secondary|Circuit Primary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109264|NCT00737672|Secondary|Circuit Primary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109265|NCT00737672|Secondary|Circuit Primary Patency|"Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.~P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve."|6 months|||Percentage of Subjects||95% Confidence Interval|Number
109266|NCT00737672|Primary|Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure|The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.|30 days|||Participants|||Number
109267|NCT00737672|Primary|Target Lesion Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~P-Value calculated from 24-month data cohort after study completion."|24 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109268|NCT00737672|Secondary|Access Secondary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109269|NCT00737672|Secondary|Access Secondary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109270|NCT00737672|Secondary|Access Secondary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Six-month estimate of secondary access patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109271|NCT00737672|Secondary|Assisted Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109272|NCT00737672|Secondary|Assisted Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109273|NCT00737672|Secondary|Assisted Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Six-month estimate of assisted primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109274|NCT00737672|Primary|Target Lesion Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|12 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109275|NCT00737672|Primary|Target Lesion Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.||Percentage of Subjects||95% Confidence Interval|Number
109276|NCT00737633|Secondary|Percent Weight Change From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)||percent change||Standard Deviation|Mean
109277|NCT00737633|Primary|Change in HbA1c From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)||percent change||Standard Deviation|Mean
109278|NCT00737594|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment|Study terminated early, data was not analyzed.|4 weeks||||||
109279|NCT00737568|Secondary|Development of Drug-resistant Mutations (DRMs)|The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.|Baseline to Week 240|Full Analysis Set||participants|||Number
109280|NCT00737568|Secondary|Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.||percentage change||Standard Deviation|Mean
109281|NCT00737568|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as grams per cubic centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.||percentage change||Standard Deviation|Mean
109282|NCT00737568|Secondary|Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240|The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being < 400 copies/mL.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.||percentage of participants|||Number
109283|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240|The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
109536|NCT00736099|Secondary|Change in FPG From Baseline to Week 54||Baseline and week 54|Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
109285|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.||percentage of participants|||Number
109286|NCT00737568|Secondary|Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.||percentage of participants|||Number
109287|NCT00737568|Secondary|Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240|Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
109288|NCT00737568|Secondary|HBV DNA Level at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.||log10 copies/mL||Standard Deviation|Mean
109289|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
109290|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240||Weeks 48, 144, 192, and 240|Full Analysis Set, missing = failure method||percentage of participants|||Number
109291|NCT00737568|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.||percentage of participants|||Number
109292|NCT00737529|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: Following is the scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|From the first dose of Lenalidomide through cycle 6 plus 28 days of last dose of Lenalidomide (maximum duration of study drug was 1006 days) and up to data cut off 02 July 2012|The Safety Population (received at least one dose of Lenalidomide) was used for all safety analysis and was identical to the ITT population.||participants|||Number
109293|NCT00737529|Secondary|Overall Survival (OS)|Kaplan Meier estimates of OS was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of overall survival was conducted in the ITT population||months||95% Confidence Interval|Median
109294|NCT00737529|Secondary|Progression-free Survival (PFS)|Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; and/or of the data-cut off of 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of progression free survival was conducted in the ITT population||months||95% Confidence Interval|Median
109295|NCT00737529|Secondary|Time to Treatment Failure (TTF)|Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to treatment failure was conducted in the ITT population||months||95% Confidence Interval|Median
109296|NCT00737529|Secondary|Time to Progression (TTP)|Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to progression was conducted in the ITT population||months||95% Confidence Interval|Median
109297|NCT00737529|Secondary|Time to Complete Response (CR+CRu)|Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with a CR. The minimum and maximum are referenced in the measure of dispersion under full range.||months||Full Range|Median
109537|NCT00736099|Secondary|Change in FPG From Baseline to Week 42||Baseline and week 42|Treated Set with values for FPG at baseline and at week 42. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
109298|NCT00737529|Secondary|Duration of Complete Response (DoCR) (CR+CRu)|Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with a CR.||months||95% Confidence Interval|Median
109299|NCT00737529|Primary|Duration of Response (DoR)|Kaplan Meier estimates for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles and/or data cut-off of 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with an overall response||months||95% Confidence Interval|Median
109300|NCT00737529|Secondary|Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu)|The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other antilymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; Non-responders are participants who discontinue before any post-baseline efficacy assessments.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; Data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of the complete response rate (CCR) was conducted using the IRC in the ITT population||percentage of participants||95% Confidence Interval|Number
109301|NCT00737529|Secondary|Time to Response (TTR)|TTR was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to response was calculated only for responding participants. The minimum and maximum are referenced in the measure of dispersion under full range.||months||Full Range|Median
109302|NCT00737529|Primary|Percentage of Participants With an Overall Response|Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of overall response was conducted in the Intent To Treat population (ITT) defined as all enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
109303|NCT00737477|Secondary|Percentage of Participants Requiring Blood Transfusions|The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.|Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||percentage of participants|||Number
109304|NCT00737477|Secondary|Percent Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."||percent change in dose||Standard Deviation|Mean
109305|NCT00737477|Secondary|Absolute Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."||mcg||Standard Deviation|Mean
109306|NCT00737477|Secondary|Number of Dose Adjustments of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."||dose adjustments||Standard Deviation|Mean
109307|NCT00737477|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis within each timeframe (n) is shown in the table."||percentage of participants|||Number
109308|NCT00737477|Secondary|Percentage of Participants With Down Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one down excursion."||percentage of participants|||Number
109309|NCT00737477|Secondary|Percentage of Participants With Up Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one up excursion."||percentage of participants|||Number
109310|NCT00737477|Secondary|Percentage of Participants With Cycles or Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated."|Weeks 4 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||percentage of participants|||Number
109311|NCT00737477|Secondary|Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.|Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data at each timepoint (n) is shown in the table."||percentage of participants|||Number
109312|NCT00737477|Secondary|Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.|Weeks 16 to 24 and Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."||weeks||Standard Deviation|Mean
109313|NCT00737477|Secondary|Change in Hb Value From Baseline to the EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|Baseline and Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||g/dL||Standard Deviation|Mean
109314|NCT00737477|Secondary|Percentage of Participants With Hb Values Within Target Range During the EEP|During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table."||percentage of participants|||Number
109315|NCT00737477|Primary|Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."||percentage of participants||95% Confidence Interval|Number
109316|NCT00737464|Secondary|Mean Values of Serum Sodium and Serum Potassium Over Time|Mean values of serum sodium and serum potassium were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||millimole per liter||Standard Deviation|Mean
145263|NCT00425269|Secondary|C-peptid, 0-h, Post-test||post-test, after completion of all six group sessions|||pmol/L||95% Confidence Interval|Mean
109317|NCT00737464|Secondary|Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time|Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||miligram per deciliter||Standard Deviation|Mean
109318|NCT00737464|Secondary|Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time|Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||units per litre||Standard Deviation|Mean
109319|NCT00737464|Secondary|Mean Values of Serum Albumin and Serum Globulin Over Time|Mean values of serum albumin and serum globulin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||gram per deciliter||Standard Deviation|Mean
109320|NCT00737464|Secondary|Mean Values of Transferrin Saturation Over Time|Mean values of Transferrin Saturation (TSAT) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Percentage||Standard Deviation|Mean
109321|NCT00737464|Secondary|Mean Values of Transferrin Over Time|Mean values of transferrin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||miligram per mililiter||Standard Deviation|Mean
109322|NCT00737464|Secondary|Mean Values of Serum Ferritin Over Time|Mean values of serum ferritin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||nanogram per mililiter||Standard Deviation|Mean
109323|NCT00737464|Secondary|Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time|Mean values of serum iron and total iron binding capacity (TIBC) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||microgram per deciliter||Standard Deviation|Mean
109324|NCT00737464|Secondary|Mean Corpuscular Volume Levels Over Time|Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||femtoliters||Standard Deviation|Mean
109325|NCT00737464|Secondary|Mean Values of Hypochromic Red Blood Cells Over Time|Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Percentage of RBCs||Standard Deviation|Mean
109326|NCT00737464|Secondary|Mean Values of White Blood Cells and Platelets Over Time|Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Per cubic millimeter||Standard Deviation|Mean
109327|NCT00737464|Secondary|Number of Participants With Abnormal Electrocardiogram|Participants with abnormal electrocardiogram were reported.|At Week -2 and Week 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.||Number of participants|||Number
109328|NCT00737464|Secondary|Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time|Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.|From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.||mmHg||Standard Deviation|Mean
109329|NCT00737464|Secondary|Mean Change From Baseline in Heart Rate Over Time|Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.|From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.||Beats per minute (bpm)||Standard Deviation|Mean
109330|NCT00737464|Secondary|Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths|Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|Safety population included all enrolled participants who received at least one dose of study drug.||Number of participants|||Number
109331|NCT00737464|Secondary|Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL|Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.|Up to Week 12|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.||Weeks||Standard Deviation|Mean
109344|NCT00737204|Primary|Role Function Scale|The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.|Measured at Baseline and Week 4|The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward.||units on a scale||Standard Deviation|Mean
109332|NCT00737464|Secondary|Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)|The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.||gm/dL||Standard Deviation|Mean
109333|NCT00737464|Primary|Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)|Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 – 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|Weeks 8 to 12 (Last 4 weeks of treatment period)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.||Percentage of participants||95% Confidence Interval|Number
109334|NCT00737438|Primary|Overall Response Will be Characterized by the Patient's FDG-PET Scan|A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline.|2 years|||participants|||Number
109335|NCT00737360|Secondary|Safety|Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.|Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.|All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation.||number of participants|||Number
109336|NCT00737360|Secondary|Overall Survival|Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.|12 months after enrollment of the last patient|||day||95% Confidence Interval|Median
109337|NCT00737360|Secondary|Antitumor Activity|"Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR., or similar text that was as accurate and appropriate."|Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.|Antitumor activity was the rate of best overall objective responses(complete response + partial response).||participants|||Number
109338|NCT00737360|Primary|Progression Free Survival(PFS)|PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.|From the date of registration until the earliest date of documented disease progression, death, or censoring event.|One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes.||day||95% Confidence Interval|Median
109339|NCT00737282|Primary|To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)||12 months|Study prematurely terminated|||||
109340|NCT00737243|Secondary|Number of Participants With a Tissue of Origin Successfully Predicted by the Assay|To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.|at baseline|Of 252 participants analyzed, the assay correctly predicted the tissue of origin in 247 patients (98%). The predicted tissue of origin could not be determined in 5 participants (2%).||participants|||Number
109341|NCT00737243|Primary|Overall Survival|Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.|every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months|Of 223 treated patients: 194 received assay-directed therapy; 29 received empiric CUP therapy. The 194 patients who received assay-directed therapy were separated into groups based on predicted responsiveness of the tumor type for further analysis.||months||95% Confidence Interval|Median
109342|NCT00737204|Secondary|HIV Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Log10 copies/mL||Standard Deviation|Mean
109343|NCT00737204|Secondary|CD4 Cell Count|Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >=100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Cells/mcL||Standard Deviation|Mean
109361|NCT00737100|Primary|Percent Predicted FEV1 Trough Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
109345|NCT00737204|Primary|Fatigue Severity Scale(FSS) Outcome|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.|Measured at baseline and Weeks 4|Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat).||units on a scale||Standard Deviation|Mean
109346|NCT00737178|Primary|Use of the IUD for Contraception at Six Months|Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).|6 months|||participants|||Number
109347|NCT00737178|Secondary|Expulsion and Removal Rates|"Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study.~Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study."|Within six months of medication abortion|Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion||participants|||Number
109348|NCT00737178|Secondary|Insertion Rates|Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.|By six months after medication abortion|||participants|||Number
109349|NCT00737100|Secondary|Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation|Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.|From first drug administration until 30 days after last drug administration (up to 121 days)|Treated set||participants|||Number
109350|NCT00737100|Secondary|Time From Dosing to the Maximum Concentration (Tmax,ss)|Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years||h||Full Range|Median
109351|NCT00737100|Secondary|Maximum Measured Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years||pg/mL||Geometric Coefficient of Variation|Geometric Mean
109352|NCT00737100|Secondary|Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)|Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years||ng||Geometric Coefficient of Variation|Geometric Mean
109353|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Parent Questionnaire|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||units on a scale||Standard Deviation|Mean
109354|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adolescents Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||units on a scale||Standard Deviation|Mean
109355|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adult Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||units on a scale||Standard Deviation|Mean
109356|NCT00737100|Secondary|Respiratory and Systemic Symptoms Questionnaire (RSSQ)|Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Participants|||Number
109357|NCT00737100|Secondary|Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12|Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
109358|NCT00737100|Secondary|Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12|Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
109359|NCT00737100|Secondary|Percent Predicted FVC Trough Response at the End of Week 12|Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
109360|NCT00737100|Secondary|Percent Predicted FVC AUC0-4 Response at the End of Week 12|Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
145264|NCT00425269|Secondary|HbA1C, Post-test||post-test, after completion of all six group sessions|||percent of Hb||95% Confidence Interval|Mean
109362|NCT00737100|Primary|Percent Predicted FEV1 AUC0-4 Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement||Percentage change||Standard Error|Least Squares Mean
109363|NCT00737061|Secondary|3 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.|3 years|Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.||percentage of participants|||Number
109364|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.||percentage of participants|||Number
109365|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.||percentage of participants|||Number
109366|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.|48 hours|Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.||percentage of participants|||Number
109367|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.|Post-Procedure|Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.||percentage of participants|||Number
109368|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.||percentage of participants|||Number
109369|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.||percentage of participants|||Number
109370|NCT00737061|Secondary|Patient Satisfaction With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.|48 hours|Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.||percentage of participants|||Number
109371|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|Including Second Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.||percentage of participants|||Number
109372|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|After First Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.||percentage of participants|||Number
109373|NCT00737061|Primary|1 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.|1 year|645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.||percentage of participants|||Number
109374|NCT00737048|Secondary|Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain|"Percentage of participants were assessed with treatment response based on evaluation criteria for efficacy of analgesics in post-tooth-extraction pain for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as very effective, effective, somewhat effective and ineffective for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as extremely useful, useful, not useful & could not be assessed for overall evaluation (OE)."|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Percentage of participants|||Number
145265|NCT00425269|Primary|Plasma Glucose, 2-h, Post-test||post-test|||mmol/L||95% Confidence Interval|Mean
109375|NCT00737048|Secondary|Number of Participants Treated With a Relief Analgesic|Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Participants|||Number
109376|NCT00737048|Secondary|Percentage of Participants With Categorical Score for Patient Impressions|Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn’t work.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Percentage of participants|||Number
109377|NCT00737048|Secondary|Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy|Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.||Minutes||Standard Deviation|Mean
109378|NCT00737048|Secondary|Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109379|NCT00737048|Secondary|Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109380|NCT00737048|Secondary|Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment|The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109381|NCT00737048|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109382|NCT00737048|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)|The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109383|NCT00737048|Secondary|Sum of Pain Intensity Difference (SPID)|Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109384|NCT00737048|Secondary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109385|NCT00737048|Primary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|8 hours|Final analysis set (FAS) population included all the participants who received the study treatment and had efficacy assessment data.||Units on a scale||Standard Deviation|Mean
109386|NCT00736996|Secondary|Change in Peak Oxygen Uptake (VO2 Peak)|Peak oxygen consumption (VO2 peak, ml/kg/min) was determined by open circuit spirometry during a standard treadmill stress test (modified Balke protocol).|Baseline to 6 months|||ml/kg/min||95% Confidence Interval|Number
109388|NCT00736996|Primary|Change in Cognitive Performance|Participants were administered a neuropsychological testing battery consisting of assessments in four cognitive domains: memory (Visual Reproduction II, Logical Memory II, Rey Auditory Verbal Learning Test), language (Boston Naming Test , Category Fluency), visuospatial (Block Design, Picture Completion), and executive function (Trail Making Test B, Digit Symbol Test). Raw test scores for these primary cognitive domain measures were transformed into age-adjusted scaled scores with a mean of 10 and a standard deviation (SD) of 3, with higher numbers indicating better cognitive performance, using the Mayo’s Older American Normative Studies data. Cognitive domain scores were calculated as the arithmetic mean of the normatively derived scaled scores for all of the tests in that domain.|Baseline to 6 months|||units on a scale||95% Confidence Interval|Number
109389|NCT00736957|Secondary|Change From Baseline in Short Form-36 (SF-36) Score|SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.|Baseline, Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure and n = the number of participants with measurements for that time point.||units on a scale||Standard Deviation|Mean
109390|NCT00736957|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4|PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.||units on scale||Standard Deviation|Mean
109391|NCT00736957|Secondary|Pain Relief (PAR) Score at Week 4|Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.||units on a scale||Standard Deviation|Mean
109392|NCT00736957|Secondary|Pain Intensity Difference (PID) at Week 4|PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.||units on a scale||Standard Deviation|Mean
109393|NCT00736957|Secondary|Number of Participants With Improvement From Baseline in VAS24 Score|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Last Observation Carried Forward (LOCF) method was used.||participants|||Number
109394|NCT00736957|Primary|Change From Baseline in VAS24 Score at Week 52|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.||millimeter||Standard Deviation|Mean
109395|NCT00736957|Primary|Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4|Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.||millimeter||Standard Deviation|Mean
109396|NCT00736944|Secondary|Progression-free Survival|Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive.|10 years from completion of treatment||08/2020||||
109397|NCT00736944|Secondary|Disease Free Survival|Time from complete response to death from any cause, to disease progression or to last follow-up alive.|10 years from completion of treatment||08/2020||||
109398|NCT00736944|Secondary|Overall Survival|Time from diagnosis to death or to last follow-up alive.|10 years from completion of treatment||08/2020||||
109399|NCT00736944|Secondary|Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis||completion of the first 10 patients induction chemotherapy|||participants|||Number
109400|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.||participants|||Number
109401|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.||participants|||Number
109538|NCT00736099|Secondary|Change in FPG From Baseline to Week 30||Baseline and week 30|Treated Set with values for FPG at baseline and at week 30. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
109402|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.||participants|||Number
109403|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.||participants|||Number
109404|NCT00736944|Secondary|Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|1 patient was not evaluable for CT scan because the primary site could not be clearly measured and was noted as non-target lesion. 1 patient was not evaluable for PET scan because the patient's insurance company denied coverage.||percentage of participants|||Number
109405|NCT00736944|Secondary|Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|12 patients were not evaluable for VSR because they did not have nodal disease. 6 patients were not evaluable for CT scan because 5 patients did not have nodal disease and 1 patient didn't have measurable nodal disease. 5 patients were not evaluable for PET because 5 patients did not have nodal disease.||percentage of participants|||Number
109406|NCT00736944|Secondary|Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|"In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests.~We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease.||percentage of participants|||Number
109407|NCT00736944|Secondary|Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion.||participants|||Number
109408|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST.||participants|||Number
109409|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline.||participants|||Number
109410|NCT00736944|Other Pre-specified|Overall Complete and Partial Response Rates by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient's insurance company denied coverage for the post-cycle 2 timepoint and because of this was not included in this overall response rate for PET scan.||participants|||Number
109539|NCT00736099|Secondary|Change in FPG From Baseline to Week 18||Baseline and week 18|Treated Set with values for FPG at baseline and at week 18. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
109411|NCT00736944|Secondary|Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured.||participants|||Number
109412|NCT00736944|Secondary|Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan.||participants|||Number
109413|NCT00736944|Secondary|Clinical Overall Complete and Partial Response Rates|"Clinical exam included laryngoscopy in office or operating room.~Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days)|||participants|||Number
109414|NCT00736944|Secondary|Clinical Complete and Partial Response Rates to the Involved Regional Nodes|"Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam.||participants|||Number
109415|NCT00736944|Secondary|Clinical Partial Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Partial response rate (PR) defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Participants who completed 2 cycles of induction therapy||participants|||Number
109416|NCT00736944|Primary|Clinical Complete Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size."|post-2 cycles of induction (approximately 42 days from start of treatment)|All patients who completed 2 cycles of induction therapy.||participants|||Number
109417|NCT00736879|Secondary|Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants|Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.|Baseline to Week 24/end of treatment plus 4 days|N=Number of participants who received at least 1 dose of study medication and had non-missing laboratory results.||participants|||Number
109418|NCT00736879|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants|12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline (BL) and Week 24 (LOCF) values.||participants|||Number
109419|NCT00736879|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants|Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.||bpm||Standard Error|Mean
109420|NCT00736879|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants|Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Participants who took at least 1 dose of double-blind study medication were analyzed. n= number of treated participants with non-missing baseline and Week 24 values.||mmHg||Standard Error|Mean
145266|NCT00425269|Primary|The Fasting Plasma Glucose, Post-test||post-test|||mmol/L||95% Confidence Interval|Mean
109421|NCT00736879|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs summarized below were prior to rescue.||participants|||Number
109422|NCT00736879|Secondary|Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.||participants|||Number
109423|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants|Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||cm||Standard Error|Mean
109424|NCT00736879|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Baseline (Day 1), Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.||Adjusted Percentage of participants|||Number
109425|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants|Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Mean
109426|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||mg/dL||Standard Error|Mean
109427|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||kg||Standard Error|Mean
145267|NCT00425269|Secondary|Intake of Fish, Baseline||baseline|||portions/week||Inter-Quartile Range|Mean
109428|NCT00736879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants|Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.||Percent Hemoglobin||Standard Error|Mean
109429|NCT00736853|Secondary|Change From Baseline in SF-36 at Day 28 of Double-Blind Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109430|NCT00736853|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
109431|NCT00736853|Secondary|Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109432|NCT00736853|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
109433|NCT00736853|Secondary|Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109434|NCT00736853|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
109435|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109436|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief.|Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.||units on a scale||Standard Deviation|Mean
109540|NCT00736099|Secondary|Change in FPG From Baseline to Week 6||Baseline and week 6|Treated Set with values for FPG at baseline and at week 6. Values after rescue therapy are set to missing.||mg/dL||Standard Deviation|Mean
109437|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Double-Blind Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109438|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Open-Label Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1 and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.||units on a scale||Standard Deviation|Mean
109439|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109440|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, and Day 8 of open-label period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
109441|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109442|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study medication. Here 'n' signifies number of participants evaluable for each time point.||units on a scale||Standard Deviation|Mean
109443|NCT00736853|Secondary|Mean PAR Score During the Double-Blind Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109444|NCT00736853|Secondary|Mean Pain Relief (PAR) Score During the Open-Label Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
109445|NCT00736853|Secondary|Mean PID During the Double-Blind Period|The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109446|NCT00736853|Secondary|Mean Pain Intensity Difference (PID) During the Open-Label Period|The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
109541|NCT00736099|Secondary|Number of Patients With Lowered HbA1c by at Least 0.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||participants|||Number
109447|NCT00736853|Secondary|Mean PI Score During Double-Blind Period|The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
109448|NCT00736853|Secondary|Mean Pain Intensity (PI) Score During Open-Label Period|PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.||units on a scale||Standard Deviation|Mean
109449|NCT00736853|Secondary|Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.||mm||Standard Deviation|Mean
109450|NCT00736853|Secondary|Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 of open-label period and Day 1 of double-blind period|Efficacy analysis set included participants who received at least one dose of study drug.||mm||Standard Deviation|Mean
109451|NCT00736853|Primary|Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period|The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.|Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.||number of participants|||Number
109452|NCT00736840|Secondary|AUC of ROC (Area Under Receiver Operating Characteristic Curve)|The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.|At study day 1 after 1 hour test|||Probability||95% Confidence Interval|Mean
109453|NCT00736840|Primary|"Number of Subjects With Likelihood of Cirrhosis Based on Hepatic Impairment Score (HIS)"|"Hepatic Impairment Score (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard."|Study day 1 after a 1 hour test|The primary efficacy was conducted on all evaluable subject data in the full analysis (FA)set with biopsy confirmed cirrhosis.||Participants|||Number
109454|NCT00736723|Primary|Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes|maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock|01 July 2008 to 31 Dec 2008|||pg/ml||Full Range|Median
109455|NCT00736580|Secondary|Surgeon Satisfaction by Likert Scale.||1 week||||||
109456|NCT00736580|Primary|Surgical Glove Perforation.|Direct measurement of the number of glove perforations listed by surgical case.|1 week|||Cases with a glove puncture|||Number
109457|NCT00736502|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Calculated as CD4+ cell count at week 48 minus the baseline value|Baseline and week 48|TS with non-missing data at baseline and week 48||Cells/mm^3||Standard Deviation|Mean
109458|NCT00736502|Secondary|Virologic Response (VR)|VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.|48 weeks|TS||Participants|||Number
109459|NCT00736502|Primary|Proportion of Patients Reporting Adverse Events|the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.|48 weeks|The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.||Percentage of participants|||Number
109460|NCT00736489|Secondary|Plasma AZD3199 AUC0-24|Area under the plasma concentration curve from time 0 to 24 h post-dose|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.||nmol*h/L||Full Range|Geometric Mean
109461|NCT00736489|Secondary|Plasma AZD3199 Cmax|Maximum plasma concentration of AZD3199 measured|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.||nmol/L||Full Range|Geometric Mean
109462|NCT00736489|Secondary|Palpitations, Average Effect Over 0 - 4 h Post-dose|Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
109463|NCT00736489|Secondary|Palpitations, Peak Effect Over 0 - 4 h Post-dose|Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
109464|NCT00736489|Secondary|Tremor, Average Effect Over 0 - 4 h Post-dose|Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
109465|NCT00736489|Secondary|Tremor, Peak Effect Over 0 - 4 h Post-dose|Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.||Score on a scale||Standard Deviation|Mean
109466|NCT00736489|Secondary|QTcB, Average Effect Over 0 - 4 h Post-dose|Average QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||ms||Standard Deviation|Mean
109467|NCT00736489|Secondary|QTcB, Peak Effect Over 0 - 4 h Post-dose|Maximum QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||ms||Standard Deviation|Mean
109468|NCT00736489|Secondary|Heart Rate, Average Effect Over 0 - 4 h Post-dose|Average heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
109469|NCT00736489|Secondary|Heart Rate, Peak Effect Over 0 - 4 h Post-dose|Maximum heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
109470|NCT00736489|Secondary|Pulse, Average Effect Over 0 - 4 h Post-dose|Average pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
109471|NCT00736489|Secondary|Pulse, Peak Effect Over 0 - 4 h Post-dose|Maximum pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||bpm||Standard Deviation|Mean
109472|NCT00736489|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
109473|NCT00736489|Secondary|Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Minimum DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
109474|NCT00736489|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
109475|NCT00736489|Secondary|Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Maximum SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.||mmHg||Standard Deviation|Mean
109476|NCT00736489|Secondary|FEV1 Average Effect Over 12 - 24 h Post-dose|FEV1 average effect over 12 h night-time period|12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
109477|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 12 h Post-dose|FEV1 average effect over 12 h day-time period|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
109478|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 24 h Post-dose|FEV1 average effect over 24 h dosing interval|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
109479|NCT00736489|Secondary|FEV1 Effect at 5 Min Post-dose|FEV1 at 5 minutes|5min|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on Placebo and 1 on AZD3199 480 mcg had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
109480|NCT00736489|Primary|S-potassium, Average Effect Over 0 - 4 h Post-dose|Average S-potassium concentration|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.||mmol/L||Standard Deviation|Mean
109481|NCT00736489|Primary|S-potassium, Peak Effect Over 0 - 4 h Post-dose|Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.||mmol/L||Standard Deviation|Mean
109482|NCT00736489|Primary|E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.|Residual FEV1 24 h post-dose|22- 26 h post dose|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
109483|NCT00736489|Primary|FEV1 Peak Effect Within 0 - 24 h Post-dose|Maximum FEV1 value|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.||L||Standard Deviation|Mean
109484|NCT00736385|Secondary|Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
109485|NCT00736385|Secondary|Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
109486|NCT00736385|Secondary|Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
109487|NCT00736385|Primary|Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|||||
109488|NCT00736333|Primary|Number of Times Premedications Were Given for Prevention of PPE|Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.|Day 1 up to 24 weeks|Safety population (those who received at least one dose of study medication)||Number of times premedication was given|||Number
109489|NCT00736333|Primary|Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)|PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.|Up to 24 weeks|Safety population (those who received at least one dose of study medication)||Occurrences|||Number
109490|NCT00736333|Primary|Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR|Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.|Cycles 1 & 3 (Week 4 & Week 12)|Safety population (those who received at least one dose of study medication)||Participants|||Number
109491|NCT00736333|Primary|Percent of Participants Taking Premedication for Prevention of IR|Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.|Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin|Safety population (those who received at least one dose of study medication)||Percent of participants|||Number
109492|NCT00736333|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|CR and PR were documented according to the clinical standards of each site.|Day 1 up to 24 weeks|Intent-to-treat (those who received at least one dose of study medication)||Participants|||Number
109493|NCT00736333|Primary|Number of Participants With Infusion Reactions (IR)|Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.|Day 1 up to Week 24|Safety population (those who received at least one dose of study medication)||Participants|||Number
109494|NCT00736255|Secondary|Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment.|Visits 2, 4, 6, & 8||||||
109495|NCT00736255|Secondary|Cognitive Functioning|This is measured by Continuous Performance Test (CPT) and N-Back|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8||||||
109496|NCT00736255|Secondary|ADHD CAARS Self-Report and Observer Short Forms|T-scores derived from compiled ADHD symptoms from two forms.|Randomization, visit 2, 4, 6, 8||||||
109497|NCT00736255|Secondary|Continuous Performance Test (CPT) Reaction Time Standard Error|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8|||Reaction time in seconds||Standard Deviation|Mean
109498|NCT00736255|Secondary|Continuous Performance Test (CPT) Commission Errors|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8|||Errors of Commission||Standard Deviation|Mean
109499|NCT00736255|Secondary|Smoking Rates|Smoking rates, measured as self-reported cigarettes/day.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8||||||
109500|NCT00736255|Primary|The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels < 4 Ppm for Each Post-quit Study Visit.|The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels < 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.|4 weeks|Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels <4ppm for each post quit study visit were analyzed for the outcome measure.||participants|||Number
110462|NCT00730236|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change from Baseline in TC|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
109501|NCT00736242|Secondary|Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment|"An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a~congenital anomaly or birth defect."|From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).|Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion.||participants|||Number
109502|NCT00736242|Secondary|Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment|The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.|From the Baseline Visit up to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available.||cells/μL||Full Range|Median
109503|NCT00736242|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment.~HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing"|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.||participants|||Number
109504|NCT00736242|Secondary|Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR).~HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing."|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.||participants|||Number
109505|NCT00736242|Secondary|Participant Study Status at End of Follow-up (EOF)|"Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA.~SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT."|From EOT to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.||participants|||Number
109506|NCT00736242|Secondary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as undetectable serum HCV-RNA at week 12 and/or a~≥2 log decline in HCV-RNA levels at week 12 from baseline."|From Treatment Week 1 to Treatment Week 12|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12.||participants|||Number
109507|NCT00736242|Secondary|Number of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable serum HCV-RNA at week 4.|At Treatment Week 4|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4||participants|||Number
109508|NCT00736242|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).|From End of Treatment to 24 weeks post-treatment (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus [HIV] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.||participants|||Number
109509|NCT00736229|Secondary|Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)||30 days|||participants|||Number
109510|NCT00736229|Secondary|Rates of Hypoglycemia and Severe Hypoglycemia|Total number of patients having at least one hypoglycemic episode (blood glucose less than 70 mg/dl), including episodes classified as severe (blood glucose less than 50 mg/dl)|1-48 hours|||participants|||Number
109511|NCT00736229|Primary|Time to Steady State|Time to steady state was defined as the time from the initiation of drug infusion (Exenatide or Insulin) to first glucose value that is ≤140 mg/dl.|Start of infusion through 48 hours or until discharge|||hours||Inter-Quartile Range|Median
109512|NCT00736229|Primary|Median Glucose Values From Steady State Through 48 Hours or Until Discharge.|Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge.|1-48 hours|Intention to treat||mg/dL||Inter-Quartile Range|Median
109513|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Who Discontinued the Study Early|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, discontinued TDF treatment after Week 24 with HBV DNA >= 400 copies/mL, and had serum sample for testing.||Participants|||Number
109542|NCT00736099|Secondary|Number of Patients With HbA1c<6.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.||participants|||Number
109514|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants With Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and had virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).||Participants|||Number
109515|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Without Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|10 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and did not have virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).||Participants|||Number
109516|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||01/2099||||
109517|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||01/2099||||
109518|NCT00736190|Secondary|Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48|Blood samples from study participants were collected for measuring HBV DNA via PCR method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
109519|NCT00736190|Secondary|Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion|HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48.|Week 48|||Participants|||Number
109520|NCT00736190|Secondary|Change From Baseline in FibroTest Value|The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant’s age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline and Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Scores on a scale||Standard Deviation|Mean
109521|NCT00736190|Secondary|Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48|Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
109522|NCT00736190|Secondary|Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48|A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L)|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study, received at least one dose of study drug, and had baseline ALT > ULN (34 U/L).||participants|||Number
109523|NCT00736190|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48|Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
109524|NCT00736190|Primary|Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)|Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.||Participants|||Number
109525|NCT00736125|Secondary|Biomarkers of Neuronal Damage||Within 72 hours after surgery||||||
109526|NCT00736125|Secondary|Systemic Inflammatory Response (SIRS) Markers||Within 72 hours after surgery||||||
109527|NCT00736125|Secondary|Cardiac Injury||Within 3 days after surgery||||||
109528|NCT00736125|Secondary|Changes in Pulmonary and Renal Function||Within 3 days after surgery||||||
109529|NCT00736125|Secondary|Delirium During Hospital Stay||First 3 days after surgery||||||
109530|NCT00736125|Secondary|Changes in Neurocognitive Tests Following Surgery||2 weeks prior to 1 year following surgery||||||
109531|NCT00736125|Secondary|Number of Patients With Emboli in the High Category||During surgery|||Patients w/ emboli in high category|||Number
109532|NCT00736125|Primary|The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)||During surgery|||emboli|||Number
109533|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Cholesterol||participants|||Number
109551|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for LDH||participants|||Number
109552|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Albumin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.|78 weeks|Treated Set with values for Albumin||participants|||Number
109553|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.|78 weeks|Treated Set with values for AP||participants|||Number
109554|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.|78 weeks|Treated Set with values for Bilirubin||participants|||Number
109555|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Glucose|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.|78 weeks|Treated Set with values for Glucose||participants|||Number
109556|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for AST||participants|||Number
109557|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for ALT||participants|||Number
109558|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Sodium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).|78 weeks|Treated Set with values for Sodium||participants|||Number
109559|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Calcium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).|78 weeks|Treated Set with values for Calcium||participants|||Number
109560|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Phosphate|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).|78 weeks|Treated Set with values for Phosphate||participants|||Number
109561|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for Creatinine kinase||participants|||Number
109562|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.|78 weeks|Treated Set with values for Creatinine||Participants|||Number
109563|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for GGT||Participants|||Number
109564|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Amylase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).|78 weeks|Treated Set with values for Amylase||Participants|||Number
109565|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Triglycerides||Participants|||Number
109566|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.|78 weeks|Treated Set with values for Uric acid||Participants|||Number
109567|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Potassium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).|78 weeks|Treated Set with values for Potassium||participants|||Number
109568|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Platelets|For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).|78 weeks|Treated Set with values for Platelets||Participants|||Number
109569|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: White Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).|78 weeks|Treated Set with values for White blood cell count||Participants|||Number
109570|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Red Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.|78 weeks|Treated Set with values for Red blood cell count||Participants|||Number
109571|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haematocrit|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.|78 weeks|Treated Set with values for Haematocrit||Participants|||Number
109572|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haemoglobin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.|78 weeks|Treated Set with values for Haemoglobin||Participants|||Number
109573|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Eosinophils|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.|78 weeks|Treated Set with values for Eosinophils||participants|||Number
109574|NCT00736099|Primary|Number of Patients With Abnormalities in Vital Signs|Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
109575|NCT00736099|Primary|Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events|Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)|78 weeks|Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug||participants|||Number
109576|NCT00736099|Primary|Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)|As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
109577|NCT00736099|Primary|Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events||78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
109578|NCT00736099|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.||Participants|||Number
109579|NCT00736073|Secondary|Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis||7 days|||participants|||Number
109580|NCT00736073|Secondary|Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis||48 hours post ERCP and 1 week post ERCP|There are 2 telephone assessments that participants are required to complete in order to analyze the outcome measure. The study team was unable to collect both assessments within the required timeframe due missed calls & lack of return calls from participants. Therefore data collection and analysis could not be completed per protocol.|||||
109581|NCT00736073|Primary|Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).||48 hours|The number of participants who received the aprepitant or placebo were evaluated for ERCP pancreatitis. Each case of ERCP pancreatitis was tracked for the participant.||cases of ERCP in participants|||Number
109582|NCT00736034|Secondary|Clinical Global Impression of Change (CGI-C)Scale|The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician’s global impression of change. Global improvement score ranges from 1 = “Very much improved”, through 4 = “No change”, to 7 = “Very much worse”. Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period.|15 weeks||||||
109583|NCT00736034|Primary|Change From Baseline in Neuropsychological Computerized Test|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|baseline, 15 weeks|||Points on a scale||Standard Deviation|Mean
109584|NCT00735969|Primary|Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.||24 weeks after treatment stop|||participants|||Number
109585|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
109586|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
109587|NCT00735943|Secondary|Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy|VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient’s VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
109588|NCT00735943|Secondary|Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen|Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
145268|NCT00425269|Secondary|Intake of Poultry, Baseline||baseline|||portions/week||Inter-Quartile Range|Mean
109589|NCT00735943|Secondary|Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA|FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
109590|NCT00735943|Secondary|Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||injections||Full Range|Median
109591|NCT00735943|Secondary|Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||injections|||Number
109592|NCT00735943|Secondary|Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA|Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.||Percentage of participants|||Number
109593|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters|A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.|12 months or last follow-up visit before study termination|Due to small sample size, the analysis was not conducted.||Percentage of participants|||Number
109594|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique.||Percentage of participants|||Number
109595|NCT00735943|Secondary|Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy|Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF analysis.||Percentage of participants|||Number
109596|NCT00735943|Primary|Median Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.||injections||Full Range|Median
109597|NCT00735943|Primary|Average Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.||injections||Standard Deviation|Mean
109610|NCT00735787|Secondary|Number of Subjects With Difficulties According to PHQ-9|Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).|Baseline and Weeks 2, 8, 16, and 28|"Analysis was based on the ITT subject population. Missing values were imputed as extremely difficult."||subjects|||Number
145269|NCT00425269|Secondary|Intake of Red Meat, Baseline||baseline|||portions/week||Inter-Quartile Range|Mean
109598|NCT00735943|Primary|Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)|VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.|Baseline through 12 months or last follow-up visit before study termination|Full Analysis Set (FAS) included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by Last Observation Carried Forward (LOCF) technique.||percentage of participants|||Number
109599|NCT00735917|Secondary|Progression-Free Survival|Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.|Progression and survival status assessed every month, up to 2 years|||months||95% Confidence Interval|Median
109600|NCT00735917|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.|From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years|No patients qualified for a confirmed response and therefore this endpoint was not analyzed.|||||
109601|NCT00735917|Secondary|Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])|"A confirmed tumor response is defined to be a CR or PR noted as > the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) > > Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to <1.0 centimeters. >~> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters."|Evaluated using the first 6 courses of treatment|||participants|||Number
109602|NCT00735917|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.|Up to 2 years|||months||95% Confidence Interval|Median
109603|NCT00735917|Primary|Six Month Survival|The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.|Up to 6 months|||percentage of patients||95% Confidence Interval|Number
109604|NCT00735904|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).||Months||95% Confidence Interval|Median
109605|NCT00735904|Secondary|Progression Free Survival (PFS)|"Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
109606|NCT00735904|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.||Months||95% Confidence Interval|Median
109607|NCT00735904|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.||Percentage of participants||95% Confidence Interval|Number
109608|NCT00735839|Primary|Number of Participants With Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.|Baseline (Day 1) to Day 84 postvaccination|||Participants|||Number
109609|NCT00735839|Primary|Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level|Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.|Baseline (Day 1) to Day 14 postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
109704|NCT00735072|Primary|Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells)||Week 24|||%CD38+ HLA-DR+ CD8+ T cells||Inter-Quartile Range|Median
109705|NCT00735072|Secondary|Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only)||Week 24||||||
109611|NCT00735787|Secondary|Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)|The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.||units on a scale||Standard Deviation|Mean
109612|NCT00735787|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)|WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).|Baseline and Weeks 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.||units on a scale||Standard Deviation|Mean
109613|NCT00735787|Secondary|Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain|On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using LOCF.||mm on scale||Standard Deviation|Mean
109614|NCT00735787|Secondary|Number of Subjects Achieving a DLQI of 0|Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
109615|NCT00735787|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.||units on a scale||Standard Deviation|Mean
109616|NCT00735787|Secondary|Number of Subjects With PASI 100|Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
109617|NCT00735787|Secondary|Number of Subjects With PASI 90|Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
109618|NCT00735787|Secondary|Number of Subjects With PASI 75|Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
109619|NCT00735787|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50|Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
109620|NCT00735787|Secondary|Number of Subjects With PGA of Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using NRI.||subjects|||Number
109621|NCT00735787|Secondary|Number of Subjects With PGA of Clear or Almost Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
109622|NCT00735787|Secondary|Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
109623|NCT00735787|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).|Baseline and Weeks 8, 16, and 28|Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.||units on a scale||Standard Deviation|Mean
109624|NCT00735787|Secondary|Number of Subjects With Marked Improvement in ESIF From Baseline|Number of subjects that achieved > 75% reduction from Baseline in ESIF|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
109625|NCT00735787|Secondary|Number of Subjects With Moderate Improvement in ESIF From Baseline|Number of subjects that achieved > 50% reduction from Baseline in ESIF.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).||subjects|||Number
109706|NCT00735072|Secondary|Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only)||Week 24||||||
109626|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Soles|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using the LOCF method.||units on a scale||Standard Deviation|Mean
109627|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Palms|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using the LOCF method.||units on a scale||Standard Deviation|Mean
109628|NCT00735787|Secondary|Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.||units on a scale||Standard Deviation|Mean
109629|NCT00735787|Primary|Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Week 16|Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.||subjects|||Number
109630|NCT00735709|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
109631|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109632|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109633|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2 and 4|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109634|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109635|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109636|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109637|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109638|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109639|NCT00735709|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis|Baseline and Weeks 1, 4, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109640|NCT00735709|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109641|NCT00735709|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109642|NCT00735709|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109643|NCT00735709|Secondary|Percentage of Participants With a Sustained Response in HAM-D24 Total Score|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|From Baseline through Week 8|Full analysis set||percentage of participants|||Number
109707|NCT00735072|Secondary|Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay)||Week 24||||||
109708|NCT00735072|Secondary|Change in CD4+ T Cell Count||Week 24||||||
109644|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Other Weeks Assessed|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Weeks 1, 2, 4 and 6|Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.||percentage of participants|||Number
109645|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109646|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
109647|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109648|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2 and 6|"Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109649|NCT00735709|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109650|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
109651|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109652|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Week 8|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Week 8|Full analysis set; last observation carried forward (LOCF) was used.||percentage of participants|||Number
109653|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109654|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109655|NCT00735709|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8|The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109656|NCT00735696|Secondary|Maximum Concentration of Ramucirumab (Cmax)||Week 18 (Cycle 6), at 1-Hour Post End of Infusion|Participants who received any quantity of study medication and had evaluable concentration data at the specified time point.||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
109657|NCT00735696|Secondary|Serum Anti-Ramucirumab Antibody Assessment|The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.|Week 15 (Cycle 5)|Participants who had Anti-Ramucirumab Antibody assessment at week 15 (cycle 5).||participants|||Number
109658|NCT00735696|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.|First dose to death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Fourteen participants were censored."||months||95% Confidence Interval|Median
109659|NCT00735696|Secondary|Progression-free Survival (PFS)|"Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause.~Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy."|First dose to measured progressive disease or death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."||months||95% Confidence Interval|Median
109660|NCT00735696|Secondary|Overall Survival (OS) at 1 Year|Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.|First dose to 1 year|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
109661|NCT00735696|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.|First dose up to 32.5 months|Participants who had tumor response. Two participants who had tumor response did not progress by the data cut-off date, therefore were censored for duration of response analysis.||months||95% Confidence Interval|Median
109662|NCT00735696|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])|Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.|First dose to measured progressive disease or death due to any cause up to 32.5 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
110292|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|1 month after enrollment|Modified intention to treat analysis||Participants|||Number
109663|NCT00735696|Secondary|Summary of Participants Reporting Adverse Events|Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Baseline up to 32.5 months|Safety Population: All participants who received any quantity of study drug.||participants|||Number
109664|NCT00735696|Primary|Percentage of Participants Who Are Progression-free (PFS) at 6 Months|Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.|6 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."||percentage of participants||95% Confidence Interval|Number
109665|NCT00735670|Secondary|Depression Scale of the Patient Health Questionnaire (PHQ-9)|The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Higher total scores indicate more severe symptomatology, ranging from 0 (no symptoms) to 27 (most severe symptoms). Data in the tables begin with the overall mean for each group that includes all subjects, average across all assessment time points. Each subsequent row reports the mean and standard deviation of each time point by allocation, noting sample size for each group in the arm/group title given missing data in each time point after baseline.|Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks|Subjects with PHQ-9 data at any of the measurement time points (baseline, weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks) are included in the means reported for each time point. The sample size for each time point is given in the category title (e.g., 10Ven = 10 venlafaxine group or 11Plac = 11 placebo group) if it deviates from baseline.||units on a scale||Standard Deviation|Mean
109666|NCT00735670|Primary|16-Item Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR16)|The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a >50% change in scores on the QIDs from baseline to week 13 (end of treatment period).|Baseline and Week 13|Participants who completed the week 13 assessment.||participants|||Number
109667|NCT00735644|Other Pre-specified|Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.|Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.||Participants|||Number
109668|NCT00735644|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.|Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.||Participants|||Number
109669|NCT00735644|Secondary|Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine|Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set.||Titer ratio||95% Confidence Interval|Geometric Mean
109670|NCT00735644|Secondary|Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.||Participants|||Number
109671|NCT00735644|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV|Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
109672|NCT00735644|Primary|Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.||Participants|||Number
109771|NCT00734630|Primary|Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)|||mmHG||Standard Deviation|Mean
109673|NCT00735618|Primary|Differences Between Pre/Post ESAS Score|Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.|Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)|Analysis included all study participants.||units on a scale||Standard Deviation|Mean
109674|NCT00735553|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated|||||
109675|NCT00735475|Secondary|New Onsets of Chronic Illness|A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.||participants|||Number
109676|NCT00735475|Secondary|Serious Adverse Events||180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.||participants|||Number
109677|NCT00735475|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|Abbreviation UAE stands for Unsolicited Adverse Event.|21 days after vaccination|||participants|||Number
109678|NCT00735475|Secondary|Duration of Local and Systemic Solicited Symptoms||5 days after vaccination|||Days||Standard Deviation|Mean
109679|NCT00735475|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms||5 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.||Percentage of Participants|||Number
109680|NCT00735475|Primary|Percentage of Participants With Seroconversion 21 Days After the Study Vaccination|Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.||Percentage of participants||95% Confidence Interval|Number
109681|NCT00735475|Primary|Geometric Mean Titer 21 Days After the Study Vaccination||21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.||Titers||95% Confidence Interval|Geometric Mean
109682|NCT00735462|Secondary|Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period|"Treatment related defined as probably related or related by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.~Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction."|Up to 16 weeks|Analysis population was based on safety population which defined as for all subjects randomized and received at lease one dose. There was one subject who randomized to the 2.5% group but received one treatment kit of 3.75% imiq cream, so this subject was assigned to 3.75% for the safety analysis.||participants|||Number
109683|NCT00735462|Primary|Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.|The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.|Up to 16 weeks|||proportion of participants||95% Confidence Interval|Number
109684|NCT00735449|Secondary|Number of Subjects With Adverse Events|Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).|Week 12|Safety population, which included all patients who started the study (randomized) and were treated.||Participants|||Number
109685|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 6|Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
109686|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 12|Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
109687|NCT00735449|Primary|Mean Intraocular Pressure (IOP) at 10 AM at Week 12|Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
109688|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 10 AM at Week 6|Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
109689|NCT00735436|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities|47 months|intent-to-treat||participants|||Number
109690|NCT00735436|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage|Incidence and severity of CNS hemorrhage|47 months|intent-to-treat||participants|||Number
109691|NCT00735436|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause, assessed up to 47 months|intent-to-treat||months||95% Confidence Interval|Median
109808|NCT00734539|Secondary|Focal Intestinal Perforation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109692|NCT00735436|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 47 months|intent-to-treat||months||95% Confidence Interval|Median
109693|NCT00735436|Secondary|24-week Progression-free Survival (PFS)|The percentage of participants surviving 24 weeks from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|24 weeks|intent-to-treat||percentage of participants||95% Confidence Interval|Number
109694|NCT00735436|Primary|24-week Overall Survival|The percentage of participants surviving 24 weeks from the start of study treatment|24 weeks|intent-to-treat||percentage of participants||95% Confidence Interval|Number
109695|NCT00735397|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.||Percent responders|||Number
109696|NCT00735397|Secondary|Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.||Percent change||Full Range|Median
109697|NCT00735397|Primary|Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.|The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study.||participants|||Number
109698|NCT00735371|Secondary|Youth Quality of Life-Research Version (YQOL-R) Total Score|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 4 weeks|FAS||Units on a scale||Standard Deviation|Mean
109699|NCT00735371|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|1, 2, 3 and 4 Weeks|FAS||Participants|||Number
109700|NCT00735371|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3 and 4 weeks|Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score)||Units on a scale||Standard Error|Least Squares Mean
109701|NCT00735306|Secondary|One Year Overall Survival From Time of Diagnosis|One year survival from time of diagnosis for patients who completed this regimen|1 year|||participants|||Number
109702|NCT00735306|Secondary|Number of Dose Limiting Toxicities||Within 30 days of completing radiation|||Events|||Number
109703|NCT00735306|Primary|Tarceva Maximum Tolerated Dose in mg|Tarceva maximum tolerated dose in mg|1 yr|||mg|||Number
109709|NCT00735007|Secondary|The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.|Information on these outcomes is shown separately above, apart from information on the incidence of injection site related adverse events which is shown in the Adverse Events section|at the end of weeks 4, 8, and 12 of treatment||||||
109710|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 12 of treatment|Intention to treat population||participants|||Number
109711|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 8 of treatment|5 subjects with missing values||participants|||Number
109712|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 4 of treatment|5 subjects with missing values||participants|||Number
109713|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 12 of treatment|Intention to treat population||mm (on a scale)||Standard Deviation|Mean
109714|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 8 of treatment|5 subjects with missing values||mm (on a scale)||Standard Deviation|Mean
109715|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 4 of treatment|4 subjects with missing values||mm (on a scale)||Standard Deviation|Mean
109716|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 12 of treatment|21 subjects with missing values||participants|||Number
109717|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 8 of treatment|21 subjects with missing values||participants|||Number
109718|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 4 of treatment|21 subjects with missing values||participants|||Number
109719|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109720|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 8 of treatment|5 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109721|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109722|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109723|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 8 of treatment|6 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109724|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109725|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109726|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109727|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109728|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109729|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109730|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values||MSTCQ Score (units on a scale)||Standard Deviation|Mean
109731|NCT00735007|Primary|The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).|"RebiSmart was evaluated as very suitable or suitable; a little suitable; or not suitable at all for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer."|End of 12 week treatment period|4 subjects with missing values||participants|||Number
109732|NCT00734994|Primary|Safety and Tolerability|Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.|During Treatment Phase average 6 weeks|||Grade 1/2 event count (no grade 3+)|Participants||Number
109733|NCT00734994|Secondary|Median Recurrence Free-survival|Time to first recurrence of cancer in the bladder.|Median follow-up 3.18 years|Entire cohort||Months||95% Confidence Interval|Median
109734|NCT00734968|Primary|Incidence of Post-operative UTI in Treatment Group|The incidence of UTI in the nitrofurantoin group was 17.6%.|6 weeks|||participants|||Number
109735|NCT00734968|Primary|Incidence of Post-operative UTI in Placebo Group|The incidence of UTI in the placebo group was 32%.|6 weeks|||participants|||Number
109736|NCT00734968|Primary|Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence|The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)|6 weeks|||participants|||Number
109737|NCT00734929|Secondary|"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"|Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)|48 hour|||participants|||Number
109738|NCT00734929|Secondary|Time to First Vomiting||48 h|The analysis population only includes participants who had vomiting and had a complete data set||hours||Inter-Quartile Range|Median
109739|NCT00734929|Secondary|Number of Vomiting Episodes||48 hours|||vomiting episodes||Inter-Quartile Range|Mean
109740|NCT00734929|Secondary|Average Nausea Score|Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable|Post OP hours 0-2, 24 h, 48 h|||units on a scale||Inter-Quartile Range|Mean
109741|NCT00734929|Secondary|Number of Participants With a Complete Response Rate|complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.|24 hours Post OP, 48 hours Post OP|||participants|||Number
109742|NCT00734929|Secondary|Use of Rescue Antiemetics||48 hour|||participants|||Number
109743|NCT00734929|Secondary|Use of Rescue Antiemetics||24 h|||participants|||Number
109744|NCT00734929|Secondary|Use of Rescue Antiemetics||Post OP (0 - 2 hours)|||participants|||Number
109745|NCT00734929|Secondary|Incidence of Vomiting|Any vomiting or retching|24 h|ITT analysis||participants|||Number
109746|NCT00734929|Secondary|Incidence of Vomiting||Post OP (0 - 2 hours)|||participants|||Number
109747|NCT00734929|Secondary|Incidence of Nausea|operative procedure|Post operative procedure (OP) hours (0-2, 24, 48)|||participants|||Number
109748|NCT00734929|Primary|Cumulative Incidence of Emesis|Any vomiting or retching|48 h|ITT analysis||participants|||Number
109749|NCT00734851|Secondary|Comparison of RNA Expression Profile From Original Prostate Radical Prostatectomy Specimen Among Those With PSA Relapse at 2 and 3 Years as Compared to Those Without PSA Relapse at the Primary Endpoint.|Prospective collection of prostate tissue at the time of radical prostatectomy is routinely performed at Duke. These samples will be analyzed by laser capture microdissection (LCM) for genomic profiling by RNA expression analysis for all subjects with tissue available. The expression profiles of subjects who experience PSA recurrence after protocol therapy by the 24 month endpoint will be compared with the expression profiles of subjects without recurrence at this time point as an exploratory measure to predict aggressive prostate cancer and those subjects who are unlikely to benefit from this approach. Baseline prostate tumor biomarkers in the form of RNA expression profiles will be correlated with 2 year PFS in an exploratory analysis. The median bPFS of those with detectable biomarker expression is reported.|2 and 3 years|Due to the unavailability of tissue, this outcome was not performed.|||||
109769|NCT00734656|Primary|Breath Alcohol|Breath Alcohol level|40 minutes after beginning drink|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||gr/dL||Standard Error|Mean
109809|NCT00734539|Secondary|Stage II or Higher Necrotizing Enterocolitis||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109750|NCT00734851|Secondary|Change in Quality of Life (QoL) After 3 Month|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline and 3 months after completing radiotherapy. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 3 months|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.||units on a scale||Full Range|Median
109751|NCT00734851|Secondary|Change in Quality of Life (QoL) After 1 Year|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline, at 3 months after completing radiotherapy, at 12 months, and at 2 and 3 years of follow-up for a total of 5 possible surveys per patient. Due to a low number of completed surveys at the fourth and fifth time point, the difference between the 12 month time point and baseline is summarized. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 1 year|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.||units on a scale||Full Range|Median
109752|NCT00734851|Secondary|Metastasis-free Survival (MFS) Rates at 2 and 3 Years.|MFS is defined as the length of time between the date of start of treatment and the date of evidence of systemic disease on bone scan or cross sectional imaging or death, whichever occurs first.|2 and 3 years|This rate is not estimable as 0 patients had locally recurrent disease before being taken off study for biochemical progression.|||||
109753|NCT00734851|Secondary|Rate of Local Recurrence at 2 and 3 Years|Local recurrence is defined as men with locally recurrent disease confirmed pathologically within the radiation field, and is estimated at 2 and 3 years.|24 months and 36 months|||percentage of participants|||Number
109754|NCT00734851|Secondary|Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.|Percentage of participants surviving 24 and 36 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount or a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks. Please note: bPFS is identical to PFS but includes only PSA-based endpoints or death.|24 months and 36 months|||percentage of patients||95% Confidence Interval|Number
109755|NCT00734851|Primary|The Rate of Progression Free Survival (PFS) at 24 Months|Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, or evidence of clinical progression or initiation of systemic therapy for progressive disease.|2 years|||percentage of patients||95% Confidence Interval|Number
109756|NCT00734799|Secondary|Nightmare Frequency|Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.|12 weeks after Baseline|||Nightmare frequency per night||Standard Error|Mean
109757|NCT00734799|Primary|Insomnia Severity|Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.|12-weeks after Baseline|Intent to treat and completed were both reported. Data on completers reported here.||ISI Score||Standard Error|Mean
109758|NCT00734747|Secondary|Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject||6 months|Note: 1 of the 66 participants was not taking proton pump inhibitors (PPIs) at baseline, therefore they were excluded from the analysis of PPI use reduction.||percentage of subjects||95% Confidence Interval|Number
109759|NCT00734747|Secondary|Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test|Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure|6 months|||percentage of time pH <4.0||Standard Deviation|Mean
109770|NCT00734630|Secondary|Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)|||mmHG||Standard Deviation|Mean
109810|NCT00734539|Secondary|Candidiasis|Definite or probable|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109760|NCT00734747|Primary|Serious Adverse Events (SAEs)|The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. “Treatment-related” events were conventionally defined as those which occurred in the first 30 days post-procedure. The SAEs presented here include all SAEs from the study, including one that occurred 35 days post-procedure (suicidal behavior). There was an interim review of early Serious Adverse Events (SAEs) after the first 24 patients. Protocol and device changes were then implemented, prior to the final 48 patients. Therefore, the SAEs are presented in two categories consisting of the first 24 patients and the final 48 patients.|6 months|||participants|||Number
109761|NCT00734747|Primary|Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score|Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire, also known as Velanovich score. The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total. This questionnaire was administered while the subjects were not taking proton pump inhibitor (PPI) medication (i.e. off-PPI). Criterion for success was an improvement >= 50% compared to baseline, at six months post procedure in at least 53% of the subjects (53% is the lower boundary of the 95% confidence interval)|Six months|||percentage of total participants||95% Confidence Interval|Number
109762|NCT00734734|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0 to 3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.||Number of participants|||Number
109763|NCT00734734|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.||Percentage of participants||95% Confidence Interval|Number
109764|NCT00734734|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).~The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.||Ratio||95% Confidence Interval|Geometric Mean
109765|NCT00734734|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
109766|NCT00734656|Secondary|Change in Serum 3a-androstanediol Glucuronide|Ratio of serum 3a-androstanediol drawn prior to alcohol administration (2-4 days after medication administration) compared to the baseline level prior to medication dose. The pharmacologic effect of dutasteride was measured by assay of serum 5a-androstan-3a,17b-diol,17-glucuronide (aka 3a-androstanediol glucuronide) as a biochemical measure of 5a-reductase enzyme inhibition. 3a-androstanediol glucuronide is the primary metabolic excretion product of 3a,5a-androstane neuroactive steroids. The|Baseline (pre medication administration) and 2-4 days post-medication (alcohol session)|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||ratio||Standard Error|Mean
109767|NCT00734656|Primary|BAES Stimulation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES)Simulation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 stimulation related questions regarding effects of alcohol. Total BAES stimulation subscale score 0-70 with higher numbers indicating greater stimulating effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||units on a scale||Standard Error|Mean
109768|NCT00734656|Primary|BAES Sedation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score 0-70 with higher numbers indicating greater sedative effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.||units on a scale||Standard Error|Mean
145270|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Baseline||baseline|||dL/week||Inter-Quartile Range|Mean
109772|NCT00734617|Primary|Continuous Abstinence From Smoking at Ten Weeks Post-quit|Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.|May 2009|||participants|||Number
109773|NCT00734604|Secondary|"Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 4 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109774|NCT00734604|Secondary|"Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 3 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109775|NCT00734604|Secondary|"Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 2 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109776|NCT00734604|Secondary|"Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 1 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109777|NCT00734604|Secondary|Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109778|NCT00734604|Secondary|Number of Participants With at Least One Serious Adverse Event|Serious adverse events are listed in the Reported Adverse Event module.|baseline through 26 weeks (including two washout periods of 1 week each)|||participants|||Number
109779|NCT00734604|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint|EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).|8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109780|NCT00734604|Secondary|Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109781|NCT00734604|Secondary|Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109782|NCT00734604|Secondary|Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection||baseline, 8 weeks of each treatment|||proportion of days||Standard Deviation|Mean
109783|NCT00734604|Secondary|Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109784|NCT00734604|Secondary|Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109785|NCT00734604|Secondary|Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109786|NCT00734604|Secondary|Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109787|NCT00734604|Primary|Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment|||units on a scale||Standard Deviation|Mean
109788|NCT00734591|Secondary|Rate of Primary Lung Cancer Diagnosis|The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population||Lung Cancer per 1000 PY||95% Confidence Interval|Number
109789|NCT00734591|Secondary|Rate of All-cause Mortality|The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population||Deaths per 1000 PY||95% Confidence Interval|Number
109790|NCT00734591|Secondary|Rate of Primary Lung Cancer Mortality Among Former Smokers|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Subset of the entire study population who were former smokers.||Deaths per 1000 PY||95% Confidence Interval|Number
109791|NCT00734591|Primary|Rate of Primary Lung Cancer Mortality|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population: all randomized participants (retrospective).||Deaths per 1000 patient years (PY)||95% Confidence Interval|Number
109792|NCT00734578|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|Baseline and weekly up to 8 weeks|FAS||Percent of participants|||Number
109793|NCT00734578|Secondary|Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF|This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
109794|NCT00734578|Secondary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
109795|NCT00734578|Secondary|Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and week 8|FAS||Percent of participants|||Number
109796|NCT00734578|Secondary|Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
109797|NCT00734578|Secondary|Change From Baseline in Conners’ Global Index – Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.|Baseline and weekly up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
109798|NCT00734578|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and weekly up to 8 weeks|FAS||Percent of participants|||Number
109799|NCT00734578|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and weekly up to 8 weeks|FAS||Percent of participants|||Number
109800|NCT00734578|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and weekly up to 8 weeks|Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study.||Units on a scale||Standard Deviation|Mean
109801|NCT00734539|Secondary|Intraventricular Hemorrhage|Grade 3 or 4|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109802|NCT00734539|Secondary|Positive Bacterial Infection From a Sterile Site||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109803|NCT00734539|Secondary|Length of Hospitalization||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||days||Inter-Quartile Range|Median
109804|NCT00734539|Secondary|Retinopathy of Prematurity Requiring Laser Surgery||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109805|NCT00734539|Secondary|Periventricular Leukomalacia||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109806|NCT00734539|Secondary|Patent Ductus Arterious Requiring Surgical Ligation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109807|NCT00734539|Secondary|Chronic Lung Disease||36 weeks corrected gestational age|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109811|NCT00734539|Secondary|Neurodevelopmental Impairment|Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy|18-22 months corrected gestational age|Attended the follow-up visit and had complete data on composite endpoint||participants|||Number
109812|NCT00734539|Primary|Death or Candidiasis|"The primary endpoint for the study is death or candidiasis.~Death prior to study day 49.~Candidiasis prior to study day 49~Definite: isolation of Candida from normally sterile body fluid (blood, CSF, urine [obtained via sterile catheterization or suprapubic tap], peritoneal fluid).~Probable:~i. > 5 days of consecutive antifungal therapy~AND both:~ii. Thrombocytopenia <150,000/mm3 iii. Positive Candida culture from nonsterile site (ETS, bag urine)"|study day 49|Modified intent-to-treat; only subjects who received at least one dose of study drug.||participants|||Number
109813|NCT00734500|Secondary|Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.|During and up to 10 days after last dose of study drug.|||participants|||Number
109814|NCT00734500|Primary|The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Area under the curve at steady state|5 days|||µg*h/mL||Full Range|Median
109815|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks|Data on any new cardiovascular (CV) event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.||participants|||Number
109816|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Pancreatitis at 104 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.||participants|||Number
109817|NCT00734474|Secondary|Antibodies to LY2189265|The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.|Baseline through 104 weeks|All randomized participants in the LY2189265 arms who had evaluable ADA data. If there were no data after the date of randomization, the endpoint was considered missing.||participants|||Number
109818|NCT00734474|Secondary|Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve|Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.|Baseline through 52 weeks|Randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) who had blood samples collected for PK assessments.||nanograms times hours per milliliter||Standard Deviation|Mean
109819|NCT00734474|Secondary|Resource Utilization|The number of visits to the emergency room (ER) is summarized cumulatively.|Baseline through 52 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.||events|||Number
109820|NCT00734474|Secondary|Participant-reported Outcomes, EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable EQ-5D data. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Deviation|Mean
109821|NCT00734474|Secondary|Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)|The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants’ quality of life. Items are scored on a 5-point numeric rating scale where 5 = “always true” and 1 = “never true”. Items are summed into 6 scales (physical function [11 items], self-esteem [7 items], sexual life [4 items], public distress [5 items], work [4 items], and total score [31 items]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale.|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable IWQoL-Lite data. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Deviation|Mean
109838|NCT00734474|Secondary|Waist Circumference Change From Baseline|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable waist circumference data. If there were no data after the date of randomization, the endpoint was considered missing.||centimeters (cm)||Standard Error|Least Squares Mean
110308|NCT00731640|Secondary|Spectacle Independence|The percentage of patients reporting spectacle independence (no longer needing to wear glasses).|6 Months|||Percentage of Participants|||Number
109822|NCT00734474|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable ECG data. If there were no data after the date of randomization, the endpoint was considered missing.||milliseconds (msec)||Standard Error|Least Squares Mean
109823|NCT00734474|Secondary|Change From Baseline in Blood Pressure|Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable SBP and DBP data. If there were no data after the date of randomization, the endpoint was considered missing.||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
109824|NCT00734474|Secondary|Change From Baseline in Pulse Rate|Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable pulse data. If there were no data after the date of randomization, the endpoint was considered missing.||beats per minute (bpm)||Standard Error|Least Squares Mean
109825|NCT00734474|Secondary|Change From Baseline in Blood Pressure at Dose Decision Point|Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting SBP and DBP data.||millimeters of mercury (mmHg)||Standard Deviation|Mean
109826|NCT00734474|Secondary|Change From Baseline in Pulse Rate at Dose Decision Point|Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting pulse rate data.||beats per minute (bpm)||Standard Deviation|Mean
109827|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Lipid Tests|The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], and triglycerides [TG]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
109828|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
109829|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR) .|Baseline through 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
109874|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 4 Months|Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
145271|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Baseline||baseline|||gram per day||Inter-Quartile Range|Mean
109830|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.||participants|||Number
109831|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 104 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.||participants|||Number
109832|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|All randomized participants in the LY2189265 and active comparator (Sitagliptin) arms.||participants|||Number
109833|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.||participants|||Number
109834|NCT00734474|Secondary|Beta Cell Function and Insulin Sensitivity (HOMA2)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point and who had evaluable HOMA2 data. If there were no data after the date of randomization, the endpoint was considered missing.||HOMA2-%||Standard Error|Least Squares Mean
109835|NCT00734474|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.||episodes per participant per year||Standard Deviation|Mean
109836|NCT00734474|Secondary|Incidence of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.||participants|||Number
109837|NCT00734474|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|The percentage of participants achieving HbA1c levels <7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
109903|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
145272|NCT00425269|Secondary|Body Mass Index, Baseline||baseline|||kg/m^2||95% Confidence Interval|Mean
109839|NCT00734474|Secondary|Durability of Change From Baseline Body Weight|Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable body weight data. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
109840|NCT00734474|Secondary|Body Weight Change From Baseline|Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable body weight data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
109841|NCT00734474|Secondary|Change From Baseline in Body Weight at Dose Decision Point|Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable body weight data.||kilograms (kg)||Standard Deviation|Mean
109842|NCT00734474|Secondary|Fasting Insulin Change From Baseline|Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable fasting insulin data. If there were no data after the date of randomization, the endpoint was considered missing.||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
109843|NCT00734474|Secondary|Fasting Blood Glucose Change From Baseline|Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable fasting plasma glucose data. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
109844|NCT00734474|Secondary|Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable HbA1c data. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of HbA1c||Standard Error|Least Squares Mean
109845|NCT00734474|Secondary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of HbA1c||Standard Error|Least Squares Mean
109846|NCT00734474|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point|Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable HbA1c data.||percentage of HbA1c||Standard Deviation|Mean
109847|NCT00734474|Primary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of HbA1c||Standard Error|Least Squares Mean
109848|NCT00734409|Secondary|Mean Days on Mechanical Ventilation|The mean number of days that the patients were on mechanical ventilation.|ICU stay- through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.||Days||Standard Deviation|Mean
109849|NCT00734409|Secondary|Unplanned Self-device Removal Events|The number of unplanned self-device removal events that took place during the study period.|ICU stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.||Event|||Number
109850|NCT00734409|Primary|Mean Sedative Use|The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.|Intensive Care Unit (ICU) stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.||ml/hour||Standard Deviation|Mean
109904|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109851|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 11 Months|Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|11 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 9 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 9 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109852|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 10 Months|Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109853|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 9 Months|Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|9 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 8 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109854|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 8 Months|Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109855|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 7 Months|Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|7 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109856|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 6 Months|Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109857|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 5 Months|Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|5 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
127591|NCT00574067|Primary|Drug Abuse Treatment Entry and Retention in the Community|entered community treatment within 10 days of release from prison (yes vs. no)|1 year|||participants|||Number
109858|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 4 Months|Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109859|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 3 Months|Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|3 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109860|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 2 Months|Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 1 subject because either the subjects missed a visit or chose not to stop therapy||cells/mm3||Full Range|Mean
109861|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 1 Months|Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410–1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|1 month after baseline|||cells/mm3||Full Range|Mean
109862|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 14 Months|The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
109863|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 12 Months|The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
109864|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 10 Months|The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
109875|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 2 Months|Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy||percentage||Full Range|Mean
109865|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 8 Months|The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
109866|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 6 Months|The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
109867|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 4 Months|The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||count per microliter||Full Range|Mean
109868|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 2 Months|The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm||count per microliter||Full Range|Mean
109869|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 14 Months|Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
109870|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 12 Months|Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
109871|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 10 Months|Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
109872|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 8 Months|Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
109873|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 6 Months|Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||percentage||Full Range|Mean
112395|NCT00712348|Other Pre-specified|Spleen Volume|Spleen volume measured by MRI in mL|Baseline and 9 Months|25 patients had spleen volume measured by MRI, 2 were MRI phobic and 3 were splenectomized||mL||Standard Deviation|Mean
109876|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 14 Months|Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
109877|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 12 Months|Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
109878|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 10 Months|Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
109879|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 8 Months|Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
109880|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 6 Months|Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
109881|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 4 Months|Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|4 months post baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy||white blood cells per microliter (mcL).||Full Range|Mean
109882|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 2 Months|Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|baseline to 2 months|Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy.||white blood cells per microliter (mcL).||Full Range|Mean
109883|NCT00734305|Secondary|To Determine the Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The AUC is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
109884|NCT00734305|Secondary|To Determine the Pharmacokinetic and Immunogenicity Parameters of MM-121|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).~Immunogenicity data is not available."|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
109885|NCT00734305|Secondary|To Describe the Dose-limiting Toxicity of MM-121 as a Monotherapy|To establish the safety of escalating doses of MM-121 administered as a monotherapy in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 47 weeks|||participants reporting DLTs|||Number
145273|NCT00425269|Secondary|Waist Circumference, Baseline||baseline|||cm||95% Confidence Interval|Mean
109886|NCT00734305|Primary|Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort from cohort 1-6. Cohort 1 began at 3.2 mg/kg IV QW and the dose escalated in separate cohorts from 6 mg/kg IV QW, 10 mg/kg IV QW, 15 mg/kg IV QW, 20 mg/kg IV QW, to the highest scheduled testing dose at 40 mg/kg one-time loading dose on cycle 1, week 1 followed by 20 mg/kg IV QW maintenance doses. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose and was used to open the expansion cohort.|From date of first dose to 30 days after termination, the longest 47 weeks|All participants in the 6 cohorts of dose escalation||mg/kg|||Number
109887|NCT00734305|Primary|Objective Response Rate and Duration|"To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response is defined as a >20% decrease in tumor burden from baseline and a Complete Response is defined as complete disappearance of tumor burden from baseline. Duration of response is defined as the length of time in weeks from observation of response until progression.~NOTE: because no patients experienced an objective response as shown below, duration of response is not presented. No duration of response could be measured."|Time from first dose to date of progression, with a median of 7.1 weeks|||participants with objective response|||Number
109888|NCT00734214|Primary|Hyponatremia|Plasma sodium less than 135 mmol/L|during the study intervention|Intention to treat analysis||participants|||Number
109889|NCT00734214|Secondary|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.||During the treatment and follow-up period||||||
109890|NCT00734214|Primary|Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)||During the treatment and follow-up period.||||||
109891|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed.||percentage of participants|||Number
109892|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.||percentage of participants|||Number
109893|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.||percentage of participants|||Number
109894|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.||percentage of participants|||Number
109895|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.||percentage of participants|||Number
109896|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.||percentage of participants|||Number
109897|NCT00734162|Secondary|Number of Participants With Changes in Drug-Resistant Mutations During the Study|The number of participants with changes in drug-resistant mutations during the study was summarized.|Baseline through Week 192|Participants with HBV DNA ≥ 400 copies/mL, with confirmed virologic breakthrough (defined as 2 consecutive increases in HBV DNA of at least 10-fold from nadir, or confirmed values ≥ 400 copies/mL after being < 400 copies/mL while on study medication), or subjects who discontinued early (after Week 24 with HBV DNA ≥ 400 copies/mL) were analyzed.||participants|||Number
109898|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109899|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109900|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109901|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109902|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109997|NCT00733421|Secondary|Satisfaction With Pain Medication|satisfied or unsatisfied with study medication, assessed by patient in questionnaire|during the first 20 days after surgery, 1st outpatient clinic visit|||patients|||Number
109905|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109906|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109907|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 48|To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject’s recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject’s recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||z-score||Standard Deviation|Mean
109908|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109909|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109910|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109911|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109912|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109913|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109914|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109915|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109916|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109917|NCT00734162|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.||percentage change||Standard Deviation|Mean
109918|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 72, 96, 144, and 192|Safety Analysis Set||percentage of participants|||Number
109919|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 96, 144, and 192|Safety Analysis Set||percentage of participants|||Number
109920|NCT00734162|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192|HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
109921|NCT00734162|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
109922|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
109923|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
109924|NCT00734162|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
109925|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
109926|NCT00734162|Primary|Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72|"Data were summarized by treatment and age group (grouped by baseline age for analysis).~In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192."|Baseline to Week 72|Safety Analysis Set: participants who received at least one dose of study drug.||percentage of participants|||Number
109927|NCT00734162|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72|"The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.~In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included."|Week 72|Full Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
109928|NCT00734149|Secondary|Median Duration of Response|Duration of response is measured from date of first confirmed response until date of disease progression.|up to 4 years|||months||95% Confidence Interval|Median
109929|NCT00734149|Secondary|Number of Patients With Any Grade or Severe Adverse Event|Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety|At any time during the study and up to 30 days after stopping the study drug|||participants|||Number
109930|NCT00734149|Primary|Response|Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A <50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a <50% reduction in the urine M-component (Bence-Jones protein.|6 weeks following completion of treatment|||participants|||Number
109931|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 4 Weeks of Treatment|"Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Units of scale||Standard Deviation|Mean
109932|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 8 Weeks of Treatment|"Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks|||Units of scale||Standard Deviation|Mean
109933|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 4 Weeks of Treatment|"Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Units of scale||Standard Deviation|Mean
109934|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 8 Weeks of Treatment|"Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks|||Units of scale||Standard Deviation|Mean
109935|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 8 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe)."|At Baseline and 8 weeks|||Days per week with pain||Standard Deviation|Mean
109936|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 4 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Days per week with pain||Standard Deviation|Mean
109998|NCT00733421|Secondary|Wound Healing|healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad|16 week follow-up|||patients|||Number
112396|NCT00712348|Other Pre-specified|Platelet Count||Every 3 months from Baseline to Month 9|||platelets/mm^3||Standard Deviation|Mean
109937|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks.|||Days per week with symptoms||Standard Deviation|Mean
109938|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks.|||Days per week with symptoms||Standard Deviation|Mean
109939|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment|"Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks|||Units on scale||Standard Deviation|Mean
109940|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment|"Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks|||Units of scale||Standard Deviation|Mean
109941|NCT00734097|Secondary|Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment|Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.|At Baseline and 4 weeks|||Days per week with symptoms||Standard Deviation|Mean
109942|NCT00734097|Primary|Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment|Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline|At Baseline and 8 weeks|||Days per week with symptoms||Standard Deviation|Mean
109943|NCT00734071|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set with available data at Baseline (139 and 136 patients) and at Week 8 (122 and 131 patients).||participants|||Number
109944|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109945|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109946|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109947|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109948|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109949|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109950|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109951|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109952|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109953|NCT00734071|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109954|NCT00734071|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
109955|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109956|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used; n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
109999|NCT00733421|Secondary|Dizziness/Sleepiness|Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire|During the 7-day pain medication period|||patients|||Number
145274|NCT00425269|Secondary|Diastolic Blood Pressure, Baseline||baseline|||mmHg||95% Confidence Interval|Mean
109957|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109958|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109959|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109960|NCT00734071|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
109961|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109962|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109963|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.||percentage of participants|||Number
109964|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109965|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
112397|NCT00712335|Secondary|Sputum RANTES Levels|Week 24 sputum RANTES levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.||pg/ml||Standard Deviation|Mean
109966|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109967|NCT00734071|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
109968|NCT00733954|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment|Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|Safety||Participants|||Number
109969|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||% BSA||Standard Deviation|Mean
109970|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||% BSA||Standard Deviation|Mean
109971|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment|Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||% BSA||Standard Deviation|Mean
109972|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||% BSA||Standard Deviation|Mean
109973|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment|Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF||% BSA||Standard Deviation|Mean
109974|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment|Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF||% BSA||Standard Deviation|Mean
109975|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
109976|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
109977|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
109978|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||Participants|||Number
109979|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||Participants|||Number
110000|NCT00733421|Secondary|Gastro-intestinal Symptoms|Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire|during the 7- day pain medication period|||patients|||Number
109980|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF||Participants|||Number
109981|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF||Participants|||Number
109982|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF||Participants|||Number
109983|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF||Participants|||Number
109984|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF||Participants|||Number
109985|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment|Baseline and Week 2|||Participants|||Number
109986|NCT00733954|Primary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|Intent-to-treat (ITT), Last observation carried forward (LOCF)||Participants|||Number
109987|NCT00733824|Secondary|Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event||30 days post transplant|||participants|||Number
109988|NCT00733824|Secondary|Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype||1 year|||mean percentage of total CD34+ cells||Standard Deviation|Mean
109989|NCT00733824|Secondary|Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration||From baseline to Day 1|||fold change||Full Range|Median
109990|NCT00733824|Primary|Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study|Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.|7 days from first dose of IV AMD3100|||participants|||Number
109991|NCT00733824|Primary|Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)|"MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose.~DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause."|7 days from first dose of IV AMD3100|||micrograms/kilograms|||Number
109992|NCT00733512|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|1 week to 10 months|contrast sensitivity data was received for only 51 of 146 patients.||log units||Standard Deviation|Mean
109993|NCT00733512|Primary|Visual Acuity|Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|1 week to 10 months|||logMAR||Standard Deviation|Mean
109994|NCT00733499|Primary|Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.|The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint|6 Months Post Surgery|The number of participants analysed is based on the number of case report forms measuring the VAS pain score that we have in our database at the 6 month time point.||units on a scale||Standard Deviation|Mean
109995|NCT00733421|Secondary|Patient Assessed Quality of Life|Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life|At 16-week post surgery follow-up|||score on a scale||Standard Deviation|Mean
109996|NCT00733421|Secondary|Patient Assessed Overall Satisfaction With Surgery/Outcome|overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.|16 weeks|||Patients.|||Number
127592|NCT00574067|Primary|Number of Days of Heroin Use|mean days used heroin during the past 30 days|1 year|||days||Standard Deviation|Mean
110002|NCT00733421|Secondary|Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain|VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70|The first 7 days after surgery, during study pain medication|||scores on a scale||Standard Deviation|Mean
110003|NCT00733421|Primary|Number of Patients Requiring Rescue Medication|Number of patients requiring any further pain medication|7 day study period|||patients|||Number
110004|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
110005|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (4Inv & 4Contr)+ 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110006|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 3 Missing outcome (0Inv & 3Contr)}||Points|Participants|Standard Deviation|Mean
110007|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110008|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110009|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110010|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110011|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
110031|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.|||Participants||
110012|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110013|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110014|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110015|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
110016|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110017|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110018|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110019|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
110020|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
145275|NCT00425269|Secondary|Systolic Blood Pressure, Baseline||baseline|||mmHg||95% Confidence Interval|Mean
110021|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome ( 0 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
110022|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110023|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early to slow recruitment rate. 5 Year data not available.|||Participants||
110024|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110025|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110026|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110027|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.|||Participants||
110028|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 2 Missing outcome (0Inv & 2Contr)}||Points|Participants|Standard Deviation|Mean
110029|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 year|106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 2 Missing outcome (1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110030|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
145276|NCT00425269|Secondary|Triglycerides, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
110032|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|2 years|106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110033|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110034|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110035|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|Study terminated early due to a slow recruitment rate. 5 year data not available.|||Participants||
110036|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)}||Points|Participants|Standard Deviation|Mean
110037|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) }||Points|Participants|Standard Deviation|Mean
110038|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}||Points|Participants|Standard Deviation|Mean
110039|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.|||Participants||
110040|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}||Points|Participants|Standard Deviation|Mean
110041|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}||Points|Participants|Standard Deviation|Mean
110042|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110043|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate, 5 year data not available.|||Participants||
110044|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}||Points|Participants|Standard Deviation|Mean
110045|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}||Points|Participants|Standard Deviation|Mean
110046|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110047|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to a slow recruitment rate.|||Participants||
110048|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
110049|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
110050|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110051|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study was terminated early due to a slow recruitment rate. 5 year data not available.|||Participants||
110135|NCT00732940|Secondary|Absolute Change From Baseline in Triglycerides at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||mmol/L||Standard Error|Mean
110052|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 1 Contr)+ 3 Lost to follow up (2 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
110053|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}||Points|Participants|Standard Deviation|Mean
110054|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110055|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study has been terminated early, therefore the 5 year data was not collected.|||Participants||
110056|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}||Points|Participants|Standard Deviation|Mean
110057|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}||Points|Participants|Standard Deviation|Mean
110058|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}||Points|Participants|Standard Deviation|Mean
110059|NCT00733369|Primary|Change From Pre-op to 1 Year Range of Motion.|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational &4 control) + 2 lost to follow up (1 Inv & 1 Contr) + 1 missing outcome (1 Inv & 0 Contr)}||Degrees|Participants|Standard Deviation|Mean
110060|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|6 months|There were 13 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||Feet||Standard Deviation|Mean
110061|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|12 weeks|There were 32 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||Feet||Standard Deviation|Mean
112398|NCT00712335|Secondary|Sputum Eotaxin Levels|Week 24 sputum eotaxin levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.||pg/ml||Standard Deviation|Mean
110062|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|8 weeks|There were 20 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.||Feet||Standard Deviation|Mean
110063|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|4 weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.||Feet||Standard Deviation|Mean
110064|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest). Pre-operatively, the subject must complete both a practice walk and a test walk.|pre-op|There were 5 missing outcomes for this endpoint.||Feet||Standard Deviation|Mean
110065|NCT00733330|Secondary|To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.|An independent radiographer will observe and record alignment|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
110066|NCT00733330|Secondary|To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographer will observe and record alignment.|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
110067|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|6 months|There were 12 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||millimeters||Standard Deviation|Mean
110068|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|12 Weeks|There were 37 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||millimeters||Standard Deviation|Mean
110069|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|8 Weeks|There were 26 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow up for this endpoint.||millimeters||Standard Deviation|Mean
110070|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|4 Weeks|There were 23 missing outcomes and 1 Consent Withdrawal for this endpoint.||millimeters||Standard Deviation|Mean
110071|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|pre-op|There were 3 missing outcomes for this endpoint.||millimeters||Standard Deviation|Mean
110072|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|5 years|The study was terminated early for business reasons therefore there are no outcomes for this endpoint.|||||
110073|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|2 years|There were 44 missing outcomes, 3 Protocol Violations, 1 Consent Withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
110074|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|1 year|There were 25 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
145277|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
110075|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|6 months|There were 16 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
110076|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|12 weeks|There were 36 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
110077|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|8 weeks|There were 22 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
110078|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|4 Weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.||points||Standard Deviation|Mean
110079|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|pre-op|There were 4 missing outcomes for this endpoint.||points||Standard Deviation|Mean
110080|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|The study was terminated before completion due to business purposes, therefore there are no results for this outcome.|||||
110081|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|There were 41 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
110082|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 Year|There were 21 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.||points||Standard Deviation|Mean
110083|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|6 Months|There were 10 missing outcomes, 1 protocol violation, 1 consent withdrawal and 2 Lost to Follow up for this endpoint.||points||Standard Deviation|Mean
110084|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|12 Weeks|There were 33 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.||points||Standard Deviation|Mean
110085|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 protocol violation, and 1 Lost to Follow Up for this endpoint.||points||Standard Deviation|Mean
110086|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this outcome.||points||Standard Deviation|Mean
110087|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|pre-op|There were 2 missing outcomes for this endpoint.||points||Standard Deviation|Mean
128264|NCT00566696|Secondary|To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants.||three years post-transplant||||||
110088|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|The study was terminated before completion due to business purposes, therefore no outcomes are available for this endpoint.|||||
110089|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|There were 41 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.||points||Standard Deviation|Mean
110090|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|There were 22 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.||points||Standard Deviation|Mean
110091|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|6 Months|There were 10 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.||points||Standard Deviation|Mean
110092|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|12 Weeks|There were 32 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.||points||Standard Deviation|Mean
110093|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 Lost to Follow Up and 1 protocol violation for this endpoint.||points||Standard Deviation|Mean
110094|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this endpoint.||points||Standard Deviation|Mean
110095|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Pre-op|Of the 84 subjects who received surgery, there were 3 missing outcomes for this endpoint.||points||Standard Deviation|Mean
110096|NCT00733330|Secondary|To Compare the Number of Optimal Implantations Achieved From Pre-op to 6-12 Weeks Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.|4 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
110097|NCT00733330|Secondary|To Compare the Proportion of Procedures That Fall Within a Satisfactory Alignment Window Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographic observer will determine and record alignment.|operative|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.|||||
110098|NCT00733330|Primary|To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)|6 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.|||||
110099|NCT00733291|Primary|Total Corneal Staining Type|Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Units on a scale||Standard Deviation|Mean
110100|NCT00733291|Secondary|Ocular Redness|"Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red."|After two hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Units on a scale||Standard Deviation|Mean
110101|NCT00733291|Primary|Average Corneal Staining Area|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Percentage area of cornea||Standard Deviation|Mean
145278|NCT00425269|Secondary|Insulin, 2-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
110102|NCT00733291|Secondary|Ocular Comfort|"Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable."|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.||Units on a scale||Standard Deviation|Mean
110103|NCT00733278|Secondary|Visibility Within the Vagina of IUD Strings at All Times.||At 3 days, 2 weeks and 6 weeks postpartum|||participants|||Number
110104|NCT00733278|Primary|Successful Retention of IUD||6 weeks|||participants|||Number
110105|NCT00733226|Secondary|Effect of OM-85 BV on Cytokine Levels|Cytokine levels were not measured during the trial because of unavailability of laboratory resources.|6 months||||||
110106|NCT00733226|Secondary|Duration of Hospitalization/Per Patient|Over the 12 months of the study we calculated mean duration of hospitalization/per patients.|12 months|||day/per patient||Standard Error|Mean
110107|NCT00733226|Secondary|Number of Hospitalizations|"During the study period of 12 months all hospitalizations for wheezing attacks were recorded.~Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.~This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial."|12 months|||hospitalization/per patient||Standard Error|Mean
110108|NCT00733226|Secondary|Number of Wheezing Attacks That Required Systemic Steroid Therapy|"All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.~At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group."|12 months|||wheezing attacks/per patient||Standard Error|Mean
110109|NCT00733226|Secondary|Number of Common Cold|"All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.~This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial."|12 months|||common cold/per patients||Standard Error|Mean
110110|NCT00733226|Secondary|Mean Duration (in Day) of Wheezing Attacks Per Patient|Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.|12 months|||day/per patient||Standard Error|Mean
110111|NCT00733226|Primary|Mean Rate of Wheezing Attacks|Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.|12 months|||wheezing attacks/per patient||Standard Error|Mean
110112|NCT00733135|Secondary|Preservation of Run-off Distal to the Filter|Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.|at the end of the procedure|115/133 subjects had the required angiographic images to assess this outcome.||percentage of participants|||Number
110113|NCT00733135|Secondary|Presence of Debris in Deployed SpiderFx™ Embolic Protection Device|Presence of debris in deployed SpiderFx™ embolic protection device|at the end of the procedure|||percentage of deployed filters|Participants||Number
110114|NCT00733135|Secondary|Residual Diameter Stenosis|This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.|at the end of the procedure|1 lesion not included because there is no angiographic core laboratory post-treatment data available||percentage of lesions|Participants||Number
110115|NCT00733135|Secondary|Technical Procedural Success|"Technical Procedural Success was defined as meeting all of the following requirements:~Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory~No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)~No device malfunction causing the procedure to be aborted~Successful delivery and placement of the SpiderFX™ embolic protection device"|at the end of the procedure|Total patient population minus one patient because there was no angiographic post-treatment core lab data available.||percentage of participants|||Number
110116|NCT00733135|Primary|Major Adverse Event Free Rate 30 Days|MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).|30 Days|||percentage of participants||95% Confidence Interval|Number
110117|NCT00733135|Primary|Successful Revascularization|Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory|at the end of the procedure|Number of lesions assessed by the angiographic core lab||percentage of lesions|Participants|95% Confidence Interval|Number
110118|NCT00733096|Secondary|Medication Reduction|Number of people who reduced medications|1 month|Patients who underwent epidural steroid injections||participants|||Number
110119|NCT00733096|Secondary|Global Perceived Effect|Satisfaction. Number of participants with positive perceived global satisfaction.|1 month|Subjects who underwent epidural steroid injections||participants|||Number
110120|NCT00733096|Secondary|Oswestry Disability Score|0-100%. 0= no disability, 100% is complete disability|1 month|Patients who received epidural steroid injections||percentage of disability out of 100%||95% Confidence Interval|Mean
110121|NCT00733096|Primary|Numerical Rating Leg Pain Score|0-10 pain score. 0= no pain, 10= worst imaginable pain.|1 month|Patients who received epidural steroid injections||units on a scale||95% Confidence Interval|Mean
110136|NCT00732940|Secondary|Median Percent Change From Baseline in Triglycerides at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110122|NCT00733005|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.|15 days of treatment|Standard deviation is pooled.||Units on a scale||Standard Deviation|Least Squares Mean
110123|NCT00733005|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|Standard deviation is pooled.||Units on a scale||Standard Deviation|Least Squares Mean
110124|NCT00732992|Secondary|Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants|Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started.|End of study (Up to individual study discontinuation)|Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST.||Participants|||Number
110125|NCT00732992|Secondary|Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose|Participants who provided a plasma concentration data was included in the analysis||nanogram/mL||Standard Deviation|Mean
110126|NCT00732992|Secondary|Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|"Terminal phase elimination half-life was calculated as natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)."|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||hours||Standard Deviation|Mean
110127|NCT00732992|Secondary|AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct*/kel), where Ct* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||microgram*hour/mL||Standard Deviation|Mean
110128|NCT00732992|Secondary|Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1||Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||microgram/mL||Standard Deviation|Mean
110129|NCT00732992|Secondary|Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||hours||Full Range|Median
110130|NCT00732992|Secondary|AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||nanogram*hour/mL||Standard Deviation|Mean
110131|NCT00732992|Secondary|Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.||nanogram/mL||Standard Deviation|Mean
110132|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 50 mg/Day Schedule-2/1 Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 6|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."||percent of total planned dose||Full Range|Median
110133|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 37.5 mg/Day Continuous Daily Dosing Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 5 (end of study)|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."||percent of total planned dose||Full Range|Median
110134|NCT00732992|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.|End of study (up to individual discontinuation)|All subjects who received at least 1 dose of the study drug.||Participants|||Number
128265|NCT00566696|Secondary|To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment.||three years post-transplant||||||
110141|NCT00732940|Secondary|Median Percent Change From Baseline in Anti-dsDNA at Week 24||Baseline, 24 weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110142|NCT00732940|Secondary|Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24||Baseline, 24 Weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.||IU/mL||Standard Error|Mean
110143|NCT00732940|Secondary|Median Percent Change From Baseline in Complement C4 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110144|NCT00732940|Secondary|Absolute Change From Baseline in Complement C4 at Week 24||Baseline, 24 weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.||mg/dL||Standard Error|Mean
110145|NCT00732940|Secondary|Median Percent Change From Baseline in Compliment C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110146|NCT00732940|Secondary|Absolute Change From Baseline in Complement C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.||mg/L||Standard Error|Mean
110147|NCT00732940|Secondary|Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24||Baseline, 24 weeks|LOCF||Percentage||Standard Error|Mean
110148|NCT00732940|Secondary|Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 Weeks|LOCF||Points on a scale||Standard Error|Mean
110149|NCT00732940|Secondary|Mean Percent Change From Baseline in PGA Score at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|LOCF||Percentage||Standard Error|Mean
110150|NCT00732940|Secondary|Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24|PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Last Observation Carried Forward (LOCF)||Scores on a 3-point scale||Standard Error|Mean
110151|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110152|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mm^3||Standard Error|Mean
110153|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110154|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mL||Standard Error|Mean
110155|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110156|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mm^3||Standard Error|Mean
110157|NCT00732940|Primary|Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110158|NCT00732940|Primary|Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||cells/mm^3||Standard Error|Mean
110159|NCT00732940|Secondary|Median Percent Change From Baseline in IgM at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110160|NCT00732940|Secondary|Absolute Change From Baseline in IgM at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||g/L||Standard Error|Mean
110161|NCT00732940|Secondary|Median Percent Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110162|NCT00732940|Secondary|Absolute Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||g/L||Standard Error|Mean
110163|NCT00732940|Secondary|Median Percent Change From Baseline in IgA at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||Percentage||Full Range|Median
110164|NCT00732940|Secondary|Absolute Change From Baseline in IgA at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||g/L||Standard Error|Mean
110165|NCT00732940|Secondary|Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.||µg/mL||Standard Deviation|Mean
110166|NCT00732940|Primary|Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 24 weeks|Please see Adverse Events Section||Percentage of participants|||Number
110167|NCT00732875|Primary|Number of Subjects Experiencing Any Infection||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study||participants|||Number
129403|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.||months||95% Confidence Interval|Number
110168|NCT00732875|Primary|Number of Subjects Experiencing Serious Adverse Event|Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.|throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.||participants|||Number
110169|NCT00732875|Primary|Number of Subjects Experiencing Any Adverse Event||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.||participants|||Number
110170|NCT00732758|Secondary|Collagen Type 1 Cross-linked C-telopeptide (CTx)|Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.|6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing participants with 6 month CTx data.||ng/mL||Standard Deviation|Mean
110171|NCT00732758|Secondary|Osteocalcin (OC)|Marker of bone formation|6 months|Intention to treat with participants analyzed in the group to which they were assigned but only using participants with 6 month OC data available.||ng/mL||Standard Deviation|Mean
110172|NCT00732758|Secondary|Parathyroid Hormone (PTH) Dietary Data||6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing those participants with follow up data for PTH at 6 months.||pg/mL||Standard Deviation|Mean
110173|NCT00732758|Primary|Serum 25-hydroxyvitamin D|Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL.|6 months|Intention to treat -- participants analyzed based on the group to which they were randomized but only included in the analysis if they had follow up data at 6 months.||ng/mL||Standard Deviation|Mean
110174|NCT00732680|Primary|Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)|The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.|2 weeks after intervention, 2 months|No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.|||||
110175|NCT00732641|Secondary|Quality of Life|Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).|Screening and Last Observation (up to 5 years)|"Intent-to-treat population (those who received at least one dose of study drug).~The number of participants analyzed varied depending on the number of observations available for each category."||Score on a scale||Standard Deviation|Mean
110176|NCT00732641|Secondary|Number of Participants With Progressive Disease(PD) or Relapse From CR|"PD (for patients not in CR) required one or more of the following:~25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells;~Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas;~Development of hypercalcemia.~Relapse from CR required at least one of the following:~Reappearance of serum or urinary paraprotein;~>5% plasma cells;~Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions;~Development of hypercalcemia."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
110177|NCT00732641|Secondary|Number of Participants With Minimal Response (MR) to Treatment|"MR was defined as:~A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks;~Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~A 25-49% reduction in the size of soft tissue plasmacytomas;~No increase in the size or number of lityc lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
110178|NCT00732641|Secondary|Number of Participants With Partial Response (PR) to Treatment|"PR was defined as:~At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks;~Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~At least 50% reduction in the size of soft tissue plasmacytomas;~No increase in size or number of lytic bone lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
110179|NCT00732641|Secondary|Number of Participants With Complete Response (CR) to Treatment|"CR was defined as:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks;~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy was performed.~No increase in size or number of lytic bone lesions (development of a compression fracture did not include response);~Disappearance of soft tissue plasmocytomas."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)||Participants|||Number
110180|NCT00732641|Secondary|Number of Days of Overall Survival (OS)|"OS was calculated from the date of randomization to the date of death for any~cause. Participants alive at the end of study were censored at the last date they were known to be alive. Participants who were still living at the end of the study were censored on the last date they were known to be alive."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)||Days||95% Confidence Interval|Median
110181|NCT00732641|Primary|Number of Days With Progression Free Survival (PFS)|"PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse.~PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)||Days||95% Confidence Interval|Median
110463|NCT00730236|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline and Week 26|Intention To Treat (ITT) Population||Percent Change||Standard Deviation|Mean
110182|NCT00732615|Secondary|Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.|Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.|8 Weeks|Intent to Treat (ITT) population.||percentage of participants|||Number
110183|NCT00732615|Secondary|Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.|Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data.||percentage of participants|||Number
110184|NCT00732615|Secondary|Percentage Changes From Baseline in Daily Calcium Dose at Week 24.|The analysis of this endpoint was based on investigator prescribed data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data||percentage change from baseline||Standard Deviation|Mean
110185|NCT00732615|Primary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.|Week 24 of dosing|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.||percentage of participants||95% Confidence Interval|Number
110186|NCT00732472|Secondary|Urine Half Life (t1/2) of UMEC on Day 7|Urine half life (t1/2) of UMEC on Day 7 was estimated. Urine samples were collected from 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.||hours||Geometric Coefficient of Variation|Geometric Mean
110187|NCT00732472|Secondary|Renal Clearance of UMEC on Day 1 and Day 7|Renal clearance was calculated as the urinary recovery of unchanged drug from time zero to time x (Ae[0-x])/area under concentration from time zero to time x (AUC[0-x]) for the longest period of time after dosing when both could be accurately determined (where x is either 8, 12, or 24). Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||Liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
110188|NCT00732472|Secondary|Fe(0-4), Fe(0-8), Fe(0-12), and Fe(0-24) of UMEC on Day 1 and Day 7|The fraction of the total dose excreted (Fe) in each interval was estimated as the urinary recovery of unchanged drug (Ae) per dose. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population: Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||Percentage of dose administered||Standard Deviation|Mean
110189|NCT00732472|Secondary|Ae(0-4), Ae(0-8), Ae(0-12), and Ae(0-24) of UMEC on Day 1 and Day 7|Urinary recovery of unchanged drug (UMEC) within the first 8, 12, and 24 hours (Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 1 and within the first 4, 8, 12, and 24 hours (Ae[0-4], Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 7 was estimated. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||nanograms (ng)||Geometric Coefficient of Variation|Geometric Mean
110190|NCT00732472|Secondary|Tmax and Tlastof UMEC on Day 1 and Day 7|Tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last quantifiable concentration of UMEC; both were measured on Day 1 and Day 7. Blood samples were collected pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.||hours||Full Range|Median
110191|NCT00732472|Secondary|Cmax of UMEC on Day 1 and Day 7|Cmax is defined as the maximum observed concentration of UMEC and was measured on Day 1 and Day 7. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
110213|NCT00732303|Primary|Progression Free Survival|To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation|24 months|No data was collected and analyzed for this outcome measure due to termination of the study|||||
110214|NCT00732238|Secondary|The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy|Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf)|Up to 180 days of end of therapy|||participants|||Number
129404|NCT00557492|Secondary|Overall Survival (OS)||Up to 48 months|Includes entire study cohort.||months||95% Confidence Interval|Number
110192|NCT00732472|Secondary|Mean AUC(0-2), AUC(0-8), and AUC(0-t) of UMEC on Day 1 and Day 7|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 2 hours (AUC[0-2]), from time zero to 8 hours (AUC[0-8]), from time zero to the last time of a quantifiable concentration of UMEC (AUC[0-t]) on Day 1 and Day 7 were measured. AUC is a measure of systemic exposure. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|Pharmacokinetic (PK) Population: participants (par.) in the ASP for whom a PK sample was obtained and analyzed. Different par. may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of par. summarized reflects everyone in the PK Population.||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
110193|NCT00732472|Primary|Mean Corpuscle Volume (MCV) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCV pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||10^-15 liters (femtoliters)||Standard Deviation|Mean
110194|NCT00732472|Primary|Mean Corpuscle Hemoglobin (MCH) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCH pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||picograms/cell (pg)||Standard Deviation|Mean
110195|NCT00732472|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil (ANC: Absolute Neutrophil Count), Platelet, and White Blood Cell (WBC) Count Values on Day 1 and Day 7|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelets, and white blood cell (WBC) count pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
110196|NCT00732472|Primary|Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values on Day 1 and Day 7|Blood samples were collected for the measurement of calcium, glucose, potassium, sodium, and urea/BUN pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
110197|NCT00732472|Primary|Direct Bilirubin, Total Bilirubin, and Creatinine Values on Day 1 and Day 7|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
110198|NCT00732472|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Values on Day1 and Day 7|Blood samples were collected for the measurement of ALP, ALT, AST, and GGT Pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||International units per liter (IU/L)||Standard Deviation|Mean
110199|NCT00732472|Primary|Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Concentration (MCHC) Values on Day 1 and Day 7|Blood samples were collected for the measurement of albumin, total protein, hemoglobin, and MCHC values pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Grams per liter (G/L)||Standard Deviation|Mean
110200|NCT00732472|Primary|Total Number of Salbutamol Doses Taken Over the 7 -Day Study Period|The total number of salbutamol doses taken per day was recorded by the participants in their dairy card over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Day 1, Day 7, and Day 8. Salbutamol was given as rescue medication, defined as a quick-relief or fast-acting medication that is given in addition to the investigational drug or placebo that can alleviate symptoms due to disease or lack of efficacy of the study treatment.|Day 1 to Day 7|All Subjects Population. Only those participants who took at least one dose of salbutamol were summarized.||salbutamol doses|||Number
110201|NCT00732472|Primary|Mean Forced Expiratory Volume in One Second (FEV1) at Screening and on Days 1 and 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured at Screening, pre-dose, and 4 hours (hr) post-dose on Day 1 and Day 7. FEV1 tests were repeated until three technically acceptable measurements were made.|Screening, Day 1, and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.||Liters||Standard Deviation|Mean
110202|NCT00732472|Primary|Maximum and Mean (0-24 Hour) Heart Rate From Holter Monitoring on Day 7|Maximum heart rate (Max HR) and mean HR from 0-24 hour Holter monitoring on treatment Day 7 were derived. The analysis was adjusted for treatment and Baseline, where Baseline is defined as the corresponding summary measure (i.e., mean heart rate [0-24 hours] or maximum heart rate [0-24 hours]) from screening records.|Day 7|All Subjects Population. The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.||Beats per minute||Standard Error|Least Squares Mean
110203|NCT00732472|Primary|Number of Participants With Abnormal 24-hour Holter Findings at Screening and Day 7|Twenty-four hour Holter ECG values were obtained at Screening and on Day 7. During the Screening procedure and study, standard Holter monitors were used (in order to exclude participants with underlying cardiac arrhythmogenicity). During the treatment periods, Holter monitors were only switched on immediately prior to dosing (up to 15 minutes pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. The following summary data were transcribed into the Case Report Form: Maximum and mean (0 to24 hour) heart rate; normal and aberrant beats and arrhythmias. Analysis of the Holter tapes was arranged by GlaxoSmithKline.The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at Screening and Day 7, are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Screening and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.||Participants|||Number
110204|NCT00732472|Primary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Values on Days 1 and 7|The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose on Day 7 are reported. The following are of potential clinical importance: absolute QTc interval >450 milliseconds (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Day 1 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr)|All Subjects Population. Only participants with data available at the indicated time points were summarized.||Participants|||Number
110205|NCT00732472|Primary|Maximum and Weighted Mean (0-4 Hour) Heart Rate at Days 1 and 7|Maximum heart rate (Max HR) and weighted mean (WM) from 0-4 hour on Days 1 and 7 were derived. Max HR (0-4 h) is defined as the maximum heart rate attained within 0-4 h. The weighted mean HR (0-4 h) was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Each of the maximum and weighted mean (0-4h) endpoints for heart rate, was statistically analyzed using a mixed effects model. The terms treatment, baseline, day and any relevant interactions were considered in the model. Least squares means are adjusted for treatment, Baseline, day, treatment by Baseline and Baseline by day interaction, where Baseline is defined as the mean of the three pre-dose assessments.|Day 1 and Day 7|All Subjects Population (ASP). The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.||Beats per minute||Standard Error|Least Squares Mean
110206|NCT00732472|Primary|Mean Heart Rate (HR) on Days 1 and 7|HR was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. HR was obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Beats per minute||Standard Deviation|Mean
110207|NCT00732472|Primary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) on Days 1 and 7|Blood pressure was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. SBP and DBP were obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population (ASP). Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
110208|NCT00732472|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any On-treatment Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An on-treatment adverse event is defined as an event that occurred between the start of investigational product and follow-up contact. Refer to the general SAE/non-serious AE module for a complete list of AEs reported in the study. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From start of treatment to study day 12|All Subjects Population: all participants who received at least one dose of study medication||participants|||Number
110209|NCT00732381|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|||Units on a scale||Standard Deviation|Least Squares Mean
110210|NCT00732381|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|The standard deviation is pooled.||Units on a scale||Standard Deviation|Least Squares Mean
110211|NCT00732303|Secondary|Overall Survival|To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|No data was collected and analyzed for this outcome measure due to termination of the study.|||||
110212|NCT00732303|Secondary|Assess Safety and Toxicity|- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|Most frequent toxicities reported.||participants|||Number
110215|NCT00732238|Primary|The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect||Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)|||participants|||Number
110216|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 20 DuoVisc eyes, 6 BioVisc eyes,4 Healon5 eyes, and 14 Amvisc Plus eyes.||Percentage of Eyes|||Number
110217|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye during Phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 19 DuoVisc eyes, 6 BioVisc eyes,3 Healon5 eyes, and 11 Amvisc Plus eyes.||Percentage of Eyes|||Number
110218|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye During Anterior Capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes||Percentage of Eyes|||Number
110219|NCT00732225|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure between 10 mmHg and 20 mmHg.|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit with the exception of the following: 3 DisCoVisc patients, 4 DuoVisc patients, 1 Healon5 patient, and 4 Amvisc Plus patients.||mmHg||Standard Deviation|Mean
110220|NCT00732225|Secondary|Aqueous Signs - Aqueous Cells|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:~0 - None~- 1 to 5 cells~- 6 to 15 cells~- 16 to 30 cells~- >30 cells"|1 day following surgery|This data was collected on all eyes of patients attending the 1 day post-operative visit.||Percentage of Eyes|||Number
110221|NCT00732225|Secondary|Aqueous Signs – Aqueous Flare|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings:~0-None: No visible flare when compared with the normal eye.~Mild: Flare visible against dark papillary background but not visible against iris background.~Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit.||Percentage of Eyes|||Number
110222|NCT00732225|Secondary|Aqueous Signs - Corneal Edema|"Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:~0 - None~- Mild, slight localized or generalized edema~- Moderate, significant localized or generalized edema~- Severe, advanced localized or generalized edema"|1 day after surgery|This data was collected on all eyes of patients attending the 1-day visit.||Percentage of Eyes|||Number
110223|NCT00732225|Primary|Percent Loss of Endothelial Cells|Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.|2 months following surgery|This data was collected on the eyes of patients attending the visit 2 months after surgery.||Percent Loss||Standard Deviation|Mean
110224|NCT00732069|Secondary|F2-Isoprostanes|Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo|During dialysis after one week of study drug|||pg/mL||Standard Error|Mean
110225|NCT00732069|Primary|Interleukin 1 Beta|Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo|During dialysis after one week of study drug|All participants who completed the three arm treatment.||pg/mL||Standard Error|Mean
110226|NCT00732030|Secondary|Patient Satisfaction Survey|Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.|6 months|||Units on a Scale||Standard Deviation|Mean
110227|NCT00732030|Primary|Residual Refractive Cylinder|Residual Refractive Cylinder at month 6 measured in diopters (D).|6 Month|||Diopters||Standard Deviation|Mean
110228|NCT00732030|Primary|Best Corrected Distance Visual Acuity|Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 Months|Data was collected for 29 eyes in 24 patients.||logMAR||Standard Deviation|Mean
110229|NCT00732030|Primary|Uncorrected Distance Visual Acuity|Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 months|Data was collected for 29 eyes in 24 patients.||logMAR||Standard Deviation|Mean
110230|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|6 months|||units on a scale||Standard Deviation|Mean
110263|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110264|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110231|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|Baseline|||units on a scale||Standard Deviation|Mean
110232|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 9|How likely the subject will need continued training or retraining?|6 weeks|||percentage of participants|||Number
110233|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 8|How easy was it for the subject to learn?|6 weeks|||percentage of participants|||Number
110234|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 7|The subject likes the OTR pump?|6 weeks|||percentage of participants|||Number
110235|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 6|The OTR pump was easy to use at 1st cycling?|6 weeks|||percentage of participants|||Number
110236|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 5|Subject training with OTR pump was easier than with previous pump?|6 weeks|||percentage of participants|||Number
110237|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 4|It was easy for the subject to compress the deflation touch pads?|6 weeks|||percentage of participants|||Number
110238|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 3|It was easy for the subject to inflate the device?|6 weeks|||percentage of participants|||Number
110239|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 2|It was easy for the subject to find the deflation touch pads?|6 weeks|||percentage of participants|||Number
110240|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 1|It was easy for the subject to find the inflation bulb?|6 weeks|||percentage of participants|||Number
110241|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 3|The subject was easily able to accommodate the OTR pump?|At implant|||percentage of responses|||Number
110242|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 2|Titan OTR pre-implant product preparation was easier than your usual pump of choice?|At implant|||percentage of responses|||Number
110243|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR Question 1|Titan OTR pre-implant product preparation was straightforward/simple?|At implant|||percentage of responses|||Number
110244|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|12 months post-surgery|||"% responding yes and probably"|||Number
110245|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|6 months post-surgery|||"% responding yes and probably"|||Number
110246|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|3 months post-surgery|||"% responding yes and probably"|||Number
110247|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|12 months post-surgery|||"% responding yes and probably"|||Number
110248|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|6 months post-surgery|||"% responding yes and probably"|||Number
110249|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|3 months post-surgery|||"% responding yes and probably"|||Number
110250|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110251|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110252|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110253|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110254|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110255|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110256|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110257|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110258|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110259|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110260|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|6 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110261|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|3 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
110262|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|12 months post-surgery|||% satisfactory or somewhat satisfactory|||Number
145279|NCT00425269|Secondary|Insulin, 0-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
110274|NCT00731939|Primary|Assess the Ease of Deflation of the Titan® OTR Pump|"The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of satisfactory or somewhat satisfactory. Other possible responses were neither satisfactory nor unsatisfactory, somewhat unsatisfactory, and very unsatisfactory."|6 months|||% of participants meeting success criter|||Number
110275|NCT00731874|Secondary|Development of New Onset Diabetes Mellitus||36 months||||||
110276|NCT00731874|Secondary|Incidence of Opportunistic Infection||36 months||||||
110277|NCT00731874|Secondary|Severity of Acute Rejection (by Banff Criteria and Need for Anti-lymphocyte Agents to Treat Acute Rejection)||12, 24, 36 months post-transplant||||||
110278|NCT00731874|Secondary|Time to Acute Rejection||12, 24, 36 months post-transplant|||months||Full Range|Median
110279|NCT00731874|Secondary|Perforin and Granzyme B mRNA Levels in Urine||Continuous||||||
110280|NCT00731874|Secondary|Renal Function (Estimated Glomerular Filtration Rate)||12, 18, 24, 36 months post-transplant||||||
110281|NCT00731874|Secondary|Incidence and Severity of Chronic Allograft Nephropathy||12, 24, 36 months post-transplant||||||
110282|NCT00731874|Secondary|Graft Survival||12, 18, 24, 36 months post-transplant||||||
110283|NCT00731874|Secondary|Patient Survival||12, 18, 24, 36 months post-transplant||||||
110284|NCT00731874|Primary|The Primary Endpoint Will be a Composite of the Following: Biopsy-confirmed Acute Rejection and Progression of Histologically Proven Chronic Allograft Nephropathy at 15 Months After Transplantation.||15 months post-transplant|||participants|||Number
110285|NCT00731822|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Day 1 and Day 28 clinic visits (60 minutes pre-dose; immediately pre-dose; post-dose after 5, 15, and 30 minutes and 1, 2, and 4 hours. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the 0 to 4 hours post-dose assessment. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline FEV1 was defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the average Day 28 FEV1 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline (pre-dose on Day 1); Day 1 and Day 28|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
110286|NCT00731822|Secondary|Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Days 2, 15, and 29 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Days 1, 14, and 28. The highest of 3 technically acceptable measurements was recorded. Baseline FEV1 is defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the Day 29 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline; Day 2, Day 15, and Day 29|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.||Liters||Standard Error|Least Squares Mean
110287|NCT00731822|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study|Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.|From Baseline (Day 1) until Follow-up (up to Study Day 37)|ITT Population||participants|||Number
110288|NCT00731822|Primary|Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period|Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.|Baseline to Day 28|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. The number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT Population without missing covariate information and with >=1 post-BL measurement are included in the analysis.||Beats per minute (bpm)||Standard Error|Least Squares Mean
110289|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|12 month after enrollment|Modified intention to treat analysis||Participants|||Number
110290|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|6 month after enrollment|Modified intention to treat analysis||Participants|||Number
145280|NCT00425269|Secondary|C-peptid, 2-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
110293|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|12 month after enrollment.|Modified intention to treat analysis||Participants|||Number
110294|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|6 month after enrollment.|Modified intention to treat analysis||Participants|||Number
110295|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|3 month after enrollment.|Modified intention to treat analysis||Participants|||Number
110296|NCT00731783|Primary|Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|1 month after enrollment.|Modified intention to treat analysis||Participants|||Number
110297|NCT00731731|Secondary|Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)|"The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing."|Up to 5 years|||participants evaluable for toxicity|||Number
110298|NCT00731731|Secondary|Time to Tumor Progression (Phase II)|Progression free survival time will be defined from date of registration to date of progression or death.|Up to 5 years|||months||95% Confidence Interval|Median
110299|NCT00731731|Secondary|Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade|Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given.|Up to 5 years|||participants evaluable for toxicity|||Number
110300|NCT00731731|Primary|Overall Survival at 15 Months (Phase II)|The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date.|Time from study registration to the date of death from any cause, assessed up to 5 years|||percentage of phase II patients||95% Confidence Interval|Number
110301|NCT00731731|Primary|Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)|"The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.~>~>~DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs:~Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting > 7 days~Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism~Grade 4 radiation-induced skin changes~Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs"|10 weeks|||number of patients with DLT|||Number
110302|NCT00731679|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.||percentage of responders|||Number
110303|NCT00731679|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.||percentage of responders|||Number
110304|NCT00731666|Secondary|The Rate of Change in Male Stress Urinary Incontinence(SUI).|"Subject responses to 3 questions were evaluated:~On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?~Overall, how often have you needed to change your daily activities because of urinary incontinence?~Overall, how big of a social problem has urinary incontinence been for you during the past month?"|12 months|||percentage of participants|||Number
110305|NCT00731666|Secondary|Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.||12 and 24 months|Subjects implanted with Titan IPP||percentage of participants|||Number
110306|NCT00731666|Primary|The Study's Primary Objective Will Assess the Change in Penile Length.||12 months|||cm||Standard Deviation|Mean
110307|NCT00731653|Primary|The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.||Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)|All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.||participants|||Number
110309|NCT00731640|Secondary|Patient Satisfaction|Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).|6 Months Postoperative|||Units on a Scale||Standard Deviation|Mean
110310|NCT00731640|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 Months|||Log Units||Standard Deviation|Mean
110311|NCT00731640|Primary|Visual Acuity|Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months|||LogMar||Standard Deviation|Mean
110312|NCT00731614|Secondary|SF-12|the SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning.|Baseline, end of treatment, 12 weeks posttreatment, 24 weeks posttreatment||06/2015||||
110313|NCT00731614|Primary|Phantom Limb Pain Questionnaire|The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)|Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.|Data analyzed for participants with complete data for all assessments using repeated measure ANOVA.||units on a scale||Standard Error|Mean
110314|NCT00731549|Secondary|Percentage of Participants Who Discontinued Due to All Causes.|Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included.||Percentage of participants|||Number
110315|NCT00731549|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) Score.|To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 2, 4, 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
110316|NCT00731549|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.|PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
110317|NCT00731549|Secondary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.|To assess CGI-S, the rater or physician will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
110318|NCT00731549|Secondary|Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.||Units on a scale||Standard Deviation|Mean
110319|NCT00731549|Secondary|Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.|Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed had available assessments for evaluation of exacerbation of psychotic symptoms/impending relapse.||Percentage of participants|||Number
110332|NCT00731211|Primary|Overall Response Rate|Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.|18 months|||percentage of patients||95% Confidence Interval|Number
110333|NCT00731198|Secondary|Side Effects||Intra-procedure and 24 hours after ERCP||||||
110334|NCT00731198|Secondary|Frequency of Post-ERCP Complications||48 hours after ERCP||||||
110335|NCT00731198|Secondary|Percentage of Successful Selective Cannulation||Intra-procedure||||||
110336|NCT00731198|Secondary|Cannulation Time||Intra-procedure||||||
145281|NCT00425269|Secondary|C-peptide, 0-h, Baseline||baseline|||pmol/L||95% Confidence Interval|Mean
110320|NCT00731549|Secondary|Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.|"Stable was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here."|Baseline to Week 28|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.||Percentage of participants|||Number
110321|NCT00731549|Secondary|Percentage of Participants Achieving Remission.|Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.|Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.||Percentage of participants|||Number
110322|NCT00731549|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|"Impending relapse criteria was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage."|Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.||Percentage of participants|||Number
110323|NCT00731549|Primary|Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).|"Stable was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here."|Baseline to Week 52/Last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.||Percentage of participants|||Number
110324|NCT00731484|Primary|Tear Osmolarity in Human Measured by TearLab System|Tear osmolarity was measured with a laboratory-on-a-chip, which simultaneously collects and analyzes the electrical impedance of a 50 nL tear sample from the inferior lateral meniscus (TearLab Osmolarity System). The results are reported in mOsm/L. The trial was not set up to evaluate diagnostic performance, as no gold-standard method was used to establish dry eye status, but rather, to determine whether the TearLab could measure tear osmolarity in human subjects.|Single visit, at time of tear osmolarity testing.|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens Syndrome||mOsms/L||Full Range|Mean
110325|NCT00731341|Secondary|Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure|Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).|Post procedure|||Score from 1 to 5||Full Range|Mean
110326|NCT00731341|Secondary|Evaluation of Length of an Average Cryoablation Procedure|Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids|Post procedure|||Minutes||Full Range|Mean
110327|NCT00731341|Secondary|Number of Participants Discharged on Day of Cryoablation Procedure.|Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.|Post procedure|||Participants|||Number
110328|NCT00731341|Secondary|Time (in Days) to Return to Normal Activity|The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.|4 weeks post procedure|||Days||Full Range|Mean
110329|NCT00731341|Secondary|Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient|Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient|Prior to hospital discharge (less than 24 hours post-procedure)|||Units on a scale from 1 to 10||Full Range|Mean
110330|NCT00731341|Primary|Number of Adverse Events|Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)|up to 4 weeks post procedure.|||Participants|||Number
110331|NCT00731211|Secondary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months|||months||95% Confidence Interval|Median
110337|NCT00731198|Primary|The Grades of the Number of Duodenal Contractions|a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.|Intra-procedure|||scores on a scale||Standard Deviation|Mean
110338|NCT00731133|Secondary|Proportion of Amphetamine-positive Urine Samples|the proportion of urine samples positive for amphetamine. Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|thrice weekly for 6 weeks|Only data from participants who received more than one dose of disulfiram were analyzed. Of the 15 participants who entered the study, one participant received only one dose so data from 14 participants were analyzed.||proportion of urines positive for amphet||Standard Deviation|Least Squares Mean
110339|NCT00731133|Primary|Side Effects Checklist|It consists of 25 items describing side effects specific to disulfiram alone or combined with alcohol or cocaine that are rated on a scale from 0 (not at all) to 4 (very much). Total scores range from 0 (minimum) to 100 (maximum). Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|Weekly for six weeks|Those who received more than one dose of disulfiram and/or completed more than one set of assessments during the protocol. Of the 15 participants who entered the study, one participant only attended clinic one day and so data were analyzed for 14 participants.||units on a scale||Standard Deviation|Least Squares Mean
110340|NCT00731120|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
110341|NCT00731120|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Full analysis set with a Baseline SF-36 measurement; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
110342|NCT00731120|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
110343|NCT00731120|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
110344|NCT00731120|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110345|NCT00731120|Secondary|Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model adjusting for Baseline CGI-S score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110346|NCT00731120|Secondary|Percentage of Participants in HAM-A Remission at Week 8|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
145282|NCT00425269|Secondary|HbA1c, Baseline||baseline|||percent of Hb||95% Confidence Interval|Mean
110347|NCT00731120|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
110348|NCT00731120|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110349|NCT00731120|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
110350|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 12|Month 12|||meters||Standard Deviation|Mean
110351|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 6|Month 6|||meters||Standard Deviation|Mean
110352|NCT00731094|Secondary|Physical Function: 6-Minute Walking Distance (6MWD)|Physical Function: 6MWD in meters measured at Month 0|Month 0|||meters||Standard Deviation|Mean
110353|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 12|||scores on a scale||Standard Deviation|Mean
110354|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 6|||scores on a scale||Standard Deviation|Mean
110355|NCT00731094|Secondary|HRQL: SF-36 Mental Component Summary Measure (MSC)|HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 0|||scores on a scale||Standard Deviation|Mean
110356|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 12|||scores on a scale||Standard Deviation|Mean
110385|NCT00730964|Secondary|The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.|The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.|Within 24 hours post contrast administration|||Serious adverse events|||Number
145283|NCT00425269|Primary|Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
110357|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 6|||scores on a scale||Standard Deviation|Mean
110358|NCT00731094|Secondary|Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)|HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 0|||scores on a scale||Standard Deviation|Mean
110359|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 12|Month 12|||mg/dL||Standard Deviation|Mean
110360|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 6|Month 6|||mg/dL||Standard Deviation|Mean
110361|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 0|Month 0|||mg/dL||Standard Deviation|Mean
110362|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 12|Month 12|||mg/dL||Standard Deviation|Mean
110363|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 6|Month 6|||mg/dL||Standard Deviation|Mean
110364|NCT00731094|Secondary|High-density Lipoprotein (HDL) Cholesterol|HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0|Month 0|||mg/dL||Standard Deviation|Mean
110365|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 12|Month 12|||mg/dL||Standard Deviation|Mean
110366|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 6|Month 6|||mg/dL||Standard Deviation|Mean
110367|NCT00731094|Secondary|Low-density Lipoprotein (LDL) Cholesterol|LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0|Month 0|||mg/dL||Standard Deviation|Mean
110368|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 12|Month 12|||mmHg||Standard Deviation|Mean
110369|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 6|Month 6|||mmHg||Standard Deviation|Mean
110370|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 0|Month 0|||mmHg||Standard Deviation|Mean
110371|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 12|Month 12|||mmHg||Standard Deviation|Mean
110372|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 6|Month 6|||mmHg||Standard Deviation|Mean
110373|NCT00731094|Secondary|Systolic Blood Pressure (BP)|Systolic BP in millimeters of mercury (mmHg) measured at Month 0|Month 0|||mmHg||Standard Deviation|Mean
110374|NCT00731094|Secondary|Weight|Weight in kilograms measured at Month 12|Month 12|||kg||Standard Deviation|Mean
110375|NCT00731094|Secondary|Weight|Weight in kilograms at measured at Month 6|Month 6|||kg||Standard Deviation|Mean
110376|NCT00731094|Secondary|Weight|Weight in kilograms (kg) measured at Month 0|Month 0|||kg||Standard Deviation|Mean
110377|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12|Month 12|||participants|||Number
110378|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6|Month 6|||participants|||Number
110379|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0|Month 0|||participants|||Number
110380|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire|Month 12|||participants|||Number
110381|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire|Month 6|||participants|||Number
110382|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire|Month 0|||participants|||Number
110383|NCT00731055|Primary|Cigarette Choice|Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.|During each of the four weekly 6-hour experimental sessions|||number of cigarette choices (0-9)||Standard Deviation|Mean
110384|NCT00731042|Primary|Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days|Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).|Baseline and 14 days|Analysis was done per protocol||units on a scale||Standard Deviation|Mean
129603|NCT00556400|Primary|Stop Vaginal Bleeding or Spotting.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
110386|NCT00730964|Primary|The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.|A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.|Within 24 hours post contrast administration|||Serious Adverse Reactions|||Number
110387|NCT00730925|Secondary|Summary of Pre-dose Concentrations of Afatnib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)|Day 15, 29 and 57|Patients with no data available for the relevant parameter and dose were excluded from analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
110388|NCT00730925|Secondary|Progression Free Survival (PFS) Time|PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Weeks||95% Confidence Interval|Median
110389|NCT00730925|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Percentage of participants||95% Confidence Interval|Number
110390|NCT00730925|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Percentage of participants||95% Confidence Interval|Number
110391|NCT00730912|Primary|Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.||ng•hr/mL||Standard Deviation|Mean
110392|NCT00730912|Primary|Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.||ng/mL||Standard Deviation|Mean
110393|NCT00730847|Primary|Number of Subjects With Grade 3, Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Grade 3 SAE = SAE which prevented normal, everyday activities. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (up to Month 7).|The analysis was performed on the Total Vaccinated cohort which included all vacinated subjects for whom data were available.||subjects|||Number
110394|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigators as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigators as causally related to the study vaccination.|During a 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vacinated subjects for whom data were available.||subjects|||Number
110395|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator as causally related to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature >39.0°C.|During a 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available and had the symptom sheet completed.||subjects|||Number
110474|NCT00730041|Secondary|Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP therapy comfort. Scores ranged from 0 (very uncomfortable) to 10 (very comfortable).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.||Scores on a Scale||Standard Deviation|Mean
110396|NCT00730847|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).|During a 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available and had the symptom sheet completed.||subjects|||Number
110397|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110398|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110399|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110400|NCT00730756|Secondary|Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)|The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110401|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110402|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110403|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110404|NCT00730756|Secondary|Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)|The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment.|Baseline through Week 4 (28 days)|ITT Population||points on a scale||Standard Error|Least Squares Mean
110405|NCT00730756|Primary|Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)|The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.|Baseline through Week 4 (28 days)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication||points on a scale||Standard Error|Least Squares Mean
110406|NCT00730730|Secondary|Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.|"Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI.~An ABI ≥ 0.90 is considered normal."|From baseline up to 30-days|Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb||limbs|Participants||Number
110407|NCT00730730|Secondary|Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.|"Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up-~Category 0: Asymptomatic, no hemodynamically significant occlusive disease;~Category 1: Mild claudication;~Category 2: Moderate claudication;~Category 3: Severe claudication;~Category 4: Ischemic rest pain;~Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia;~Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable"|From baseline up to 30-days|Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs||limbs|Participants||Number
110408|NCT00730730|Secondary|Number of Participants With Acute Success|angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)|from after stent placement to prior to hospital discharge (up to 3 days)|Intent to Treat population(ITT); missing angiographic data for one patient||participants|||Number
110409|NCT00730730|Primary|The Number of Participants With Major Adverse Events (MAE)|Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry|30 days|Intent-to-treat population (ITT)||participants|||Number
110410|NCT00730691|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
110411|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 4 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110412|NCT00730691|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110413|NCT00730691|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
110414|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110415|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
110484|NCT00730015|Secondary|12-week Change in Constipation Severity|"Constipation severity was based on a 5-point ordinal scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 10 patients who dropped out prior to finishing 1 week of the trial have missing data. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
110416|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110417|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110418|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110419|NCT00730691|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
110420|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
110421|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; Last observation carried forward (LOCF) was used.||percentage of participants|||Number
110422|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
110423|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
110527|NCT00729859|Secondary|Homeostasis Model of Insulin Resistance (HOMA-IR)|HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol||HOMA score||Standard Deviation|Mean
110424|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
110425|NCT00730691|Primary|Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.||scores on a scale||Standard Error|Least Squares Mean
110426|NCT00730639|Secondary|Mean Effective Half-life (T-HALFeff)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of T-HALFeff was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||hours (h)||Standard Deviation|Mean
110427|NCT00730639|Secondary|Geometric Mean Total Body Clearance of Drug From Serum (CLT)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples Blood samples were assessed at all doses from a subset of participants. The PK parameter of CLT was measured in milliliters per hour (mL/h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
110428|NCT00730639|Secondary|Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of AUC was measured in micrograms*hours per milliliter (μg*h/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||micrograms*hours per milliliter (μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
110429|NCT00730639|Secondary|Median Time of Maximum Serum Concentration (Tmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed Blood samples were assessed at all doses from a subset of participants. The PK parameter of Tmax was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||hours (h)||Full Range|Median
110430|NCT00730639|Primary|Number of Participants With Abnormal Hematology Laboratory Values|Hemoglobin, Lymphocytes, Neutrophils, Platelets and Leukocytes. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for Hemoglobin were based on Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for Neutrophils were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0. Abnormal values for Leukocytes were based on Gr 1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.||participants|||Number
110431|NCT00730639|Secondary|Geometric Mean Maximum Serum Concentration (Cmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA). Blood samples were assessed at all doses from a subset of participants. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
110432|NCT00730639|Secondary|Duration of Tumor Response|Duration of tumor response (DOR) was calculated from the first date of response of complete response (CR) or partial response (PR) to the date of the first progressive disease (PD) or the date of death. Duration of response was censored at the last tumor assessment date if a responder did not have PD or death. Nonresponders were not included in the analysis. Median DOR was estimated by Kaplan-Meier analysis.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with a measurable tumor response were analyzed.||months||Full Range|Median
110441|NCT00730327|Secondary|Change in Quality of Life (IWQOL-Lite)|The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).||units on a scale||Standard Deviation|Mean
145284|NCT00425269|Primary|The Fasting Plasma Glucose Value, Baseline||baseline|||mmol/L||95% Confidence Interval|Mean
110433|NCT00730639|Secondary|Objective Response Rate|Tumor response was evaluated by the sponsor based on tumor assessments by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate (ORR) was defined as the proportion of participants who's confirmed best overall response (BOR) is either complete (CR) or partial (PR), where the denominator is the number of treated participants in the population of interest. Response was based on tumor measurements. Responders= complete response (CR) or partial response (PR). CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. 95% Confidence intervals (CIs) were computed using the Clopper Pearson method.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with an evaluable tumor response were analyzed.||percentage of participants||95% Confidence Interval|Number
110434|NCT00730639|Secondary|Immunogenicity Assessment|Classification of participants host immune response was based on the following definitions: Anti-Drug Antibody (ADA) Positive Subjects have with at least one ADA positive sample at any time after initiation of treatment. ADA positive subjects were further classified into categories with Persistent Positive defined as an ADA positive sample at 2 or more sequential timepoints at least 8 weeks apart.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab and were ADA-evaluable were analyzed.||participants|||Number
110435|NCT00730639|Primary|Number of Participants With Abnormal Serum Chemistry Laboratory Values|Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine and Total Bilirubin. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.||participants|||Number
110436|NCT00730639|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||participants|||Number
110437|NCT00730327|Post-Hoc|Percent Total Body Weight Loss (%TBWL)|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).||percentage of TBWL||95% Confidence Interval|Mean
110438|NCT00730327|Post-Hoc|Percent EWL (Using BMI=25 kg/m²)|"Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)||percentage of EWL||Standard Deviation|Mean
110439|NCT00730327|Post-Hoc|Change in BMI|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).||kg/m²||Standard Deviation|Mean
110440|NCT00730327|Secondary|Change in Participant Depression (Beck Depression Inventory II)|Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)||units on a scale||Standard Deviation|Mean
110457|NCT00730236|Secondary|Percent Change From Baseline in Apolipoprotein AI (Apo AI)|Percent change from Baseline in Apo AI|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
110458|NCT00730236|Secondary|Percent Change From Baseline in Non-HDL-C|Percent change from Baseline in non-HDL-C|Baseline and Week 26|ITT Population||Percent Change||Standard Deviation|Mean
110442|NCT00730327|Secondary|Change in Quality of Life (SF-36)|The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.|Baseline, Week 39|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).||units on a scale||Standard Deviation|Mean
110443|NCT00730327|Secondary|Percent of Participants With Comorbid Conditions|"The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.~Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.~Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.~Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female)."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).||percentage of participants|||Number
110444|NCT00730327|Primary|Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group|"The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.~%EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.~Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table."|9 months|Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).||percentage of BIB participants||95% Confidence Interval|Number
110445|NCT00730327|Primary|Mean Percent Excess Weight Loss (%EWL)|"The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight."|9 months|Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).||percentage of EWL||Standard Deviation|Mean
110446|NCT00730275|Secondary|Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo|"Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose.~WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity."|Pre-dose through 24 hours post-dose|All participants who received a single dose of sitagliptin or placebo.||Percent inhibition||95% Confidence Interval|Least Squares Mean
110447|NCT00730275|Secondary|Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin|Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||hours||Standard Deviation|Mean
110448|NCT00730275|Secondary|Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||hours||Full Range|Median
110449|NCT00730275|Secondary|Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||nM||95% Confidence Interval|Geometric Mean
110450|NCT00730275|Primary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin|Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.||nM*hour||95% Confidence Interval|Geometric Mean
110451|NCT00730275|Primary|Number of Participants Who Experienced at Least One Adverse Event||Pre-study through 10 to 14 days following administration of study drug|All enrolled participants.||participants|||Number
110452|NCT00730236|Secondary|Absolute Change From Baseline in Weight|Absolute change from Baseline in weight|Baseline and Week 78|All patients treated||kg||Standard Deviation|Mean
110453|NCT00730236|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and Week 78|All patients treated||mg/dL||Standard Deviation|Mean
110454|NCT00730236|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and Week 78|All patients treated||U/L||Standard Deviation|Mean
110455|NCT00730236|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and Week 78|All patients treated||U/L||Standard Deviation|Mean
110456|NCT00730236|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and Week 78|All patients treated||Percent Hepatic Fat||Standard Deviation|Mean
110464|NCT00730132|Primary|Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.||mmol/L||Standard Deviation|Mean
110465|NCT00730132|Primary|Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.||mmol/L||Standard Deviation|Mean
110466|NCT00730132|Primary|Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation||Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded.||Percentage of patients|||Number
110467|NCT00730132|Primary|Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation|Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.||Percentage of patients|||Number
110468|NCT00730132|Primary|Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin.|Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|During the study|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol violations were recorded. One subject each from ezetimibe added to existing statin and new statin group were excluded (missing data)||Percentage of patients|||Number
110469|NCT00730041|Secondary|Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)|The CPAP machine has an internal clock/calendar, and capabilities to record usage onto a removable data card the size of a credit card. Data is recorded from the first time the machine is turned on to the last time the machine is turned on during a given period in which the SmartCard is present in the machine. The SmartCard records all days during the given period and keeps track of days in which the CPAP machine is used and days in which it is not used. The SmartCard data is able to be downloaded to a computer for review and analysis.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.||Average hours per day of days used||Standard Deviation|Mean
110470|NCT00730041|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.|The FOSQ can assess the quality of sleep and this scale is a validated measure the impact of excessive sleepiness on multiple activities of daily living. It has 30 questions in 5 subgroups of general productivity (8 questions), social outcome (2), activity level (9), vigilance (7), and intimate relationships and sexual activity (4). Responses for each question range from 1 (extreme difficulty or low activity level) to 4 (no difficulty or high activity level) for each subgroup. A mean is calculated for each subgroup, and then the mean of the subgroups is calculated and multiplied by 5.|Baseline and 4 months post-procedure|Two subjects became lost to follow-up and did not return for the final study visit.||Scores on a Scale||Standard Deviation|Mean
110471|NCT00730041|Secondary|Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.|The Epworth Sleepiness Scale (ESS) was included in the subject questionnaire as a tool to further assess the quality of sleep for each subject throughout the follow-up period. This scale is a validated clinical indicator that quantifies the patient’s chance of falling asleep during eight different activities of daily living such as reading, talking, resting and driving. Each of the eight questions has four possible responses: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing to 3 = high chance of dozing, for a possible maximum score of 24.|Baseline and 4 months post-procedure|Two participants became lost to follow-up and did not return for the final study visit.||Scores on a Scale||Standard Deviation|Mean
110472|NCT00730041|Secondary|Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP satisfaction. Scores ranged from 0 (very unsatisfied) to 10 (very satisfied).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.||Scores on a Scale||Standard Deviation|Mean
110473|NCT00730041|Secondary|Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)|Leak is an indicator of mask/headgear fit and can also be used to substantiate or contradict an assigned therapeutic pressure. Total leak is the sum of intentional leak to prevent carbon dioxide rebreathing and unintentional leak. Each mask has a known amount of leak (the intentional leak), and subjects were instructed not to changes masks to minimize this variable. Approximate range is 0-100, and the amount of leak increases as the number increases. Average leak values are in the 20-50 liters per minute range. The CPAP machine records leak data during each night of usage and can average.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.||Units on a scale||Standard Deviation|Mean
110475|NCT00730041|Primary|Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration|The American Academy of Sleep Medicine’s (AASM) recommended treatment for patients with obstructive sleep apnea (OSA) is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to prevent collapse of the upper airway. CPAP pressures are measured in centimeters of water, and range in whole numbers from 4cm H2O to 20cm H2O. The therapeutic pressure is usually determined during overnight polysomnography and usually performed by a technician.|Baseline and 3 months post-procedure|50 of 51 total participants returned to the sleep lab for the 90-day PSG. All 50 participants are part of the primary endpoint analysis.||centimeters of water (cm H2O)||Standard Deviation|Mean
110476|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|All participants enrolled in the trial.||percentage of participants||95% Confidence Interval|Number
110477|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.||percentage of participants||95% Confidence Interval|Number
110478|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|All participants enrolled in the trial.||percentage of participants||95% Confidence Interval|Number
110479|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.||percentage of participants||95% Confidence Interval|Number
110480|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The ITT population was comprised of all participants enrolled in the trial.||percentage of participants||95% Confidence Interval|Number
110481|NCT00730028|Secondary|Number of Participants Reporting Adverse Events That Are Treatment Limiting.|Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.||participants|||Number
110482|NCT00730028|Secondary|Number of Participants Reporting Adverse Events.|Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.||participants|||Number
110483|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.||percentage of participants||95% Confidence Interval|Number
110485|NCT00730015|Secondary|12-week Change in Bloating|"Bloating was based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
110486|NCT00730015|Secondary|12-week Change in Abdominal Discomfort|"Abdominal discomfort is based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
110487|NCT00730015|Secondary|12-week Change in Severity of Straining|"Severity of Straining is measured on a 5-point scale, where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
110488|NCT00730015|Secondary|12-week Change in Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.||units on a scale||Standard Error|Least Squares Mean
110489|NCT00730015|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The number of SBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||SBMs per Week||Standard Error|Least Squares Mean
110490|NCT00730015|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The number of CSBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.||CSBMs per Week||Standard Error|Least Squares Mean
110491|NCT00730015|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.||participants|||Number
110492|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110493|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110494|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.||days||Standard Deviation|Mean
110495|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||days||Standard Deviation|Mean
110496|NCT00729937|Secondary|Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class|All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110497|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110498|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110499|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110500|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110501|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110502|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110503|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110504|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110505|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110506|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110507|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110508|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110509|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110510|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110511|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110512|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110513|NCT00729937|Secondary|Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110514|NCT00729937|Secondary|Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110515|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110528|NCT00729859|Secondary|Quantitative Insulin Sensitivity Check Index (QUICKI)|QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol||QUICKI index||Standard Deviation|Mean
145285|NCT00425113|Secondary|Time to Sputum Culture Conversion to Negative on Solid Medium||2 months|||days||95% Confidence Interval|Median
110516|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110517|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110518|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110519|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110520|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110521|NCT00729937|Primary|Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.||participants|||Number
110522|NCT00729937|Secondary|Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.||participants|||Number
110523|NCT00729924|Secondary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.|This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).|Day 7|||ratio||Inter-Quartile Range|Median
110524|NCT00729924|Primary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.|The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).|Day 7|||1/h||Inter-Quartile Range|Median
110525|NCT00729859|Secondary|Fasting Lipid Levels||Baseline, Day 28, Day 56|per protocol||mmol/L||Standard Deviation|Mean
110526|NCT00729859|Secondary|Fasting Serum Insulin||Baseline, Day 28, Day 56|per protocol||picomolar||Standard Deviation|Mean
110529|NCT00729859|Secondary|Sex Hormone Binding Globulin (SHBG)||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.||nmol/L||Standard Deviation|Mean
110530|NCT00729859|Secondary|Estradiol Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.||pmol/L||Standard Deviation|Mean
110531|NCT00729859|Secondary|Testosterone Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.||nmol/L||Standard Deviation|Mean
110532|NCT00729859|Secondary|Luteinizing Hormone Concentration (LH)||Baseline, Day 28|The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.||IU/L||Standard Deviation|Mean
110533|NCT00729859|Secondary|Follicle Stimulating Hormone (FSH)||Baseline, 28 days|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.||IU/L||Standard Deviation|Mean
110534|NCT00729859|Primary|Endothelial Progenitor Cells|Number of CD33 + CD134+ cells as a percentage of all lymphocytes|Baseline, Day 28|Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed||percentage of all lymphocytes||Standard Deviation|Mean
110535|NCT00729846|Primary|Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.||1 Year|||percent of participants|||Number
110536|NCT00729833|Secondary|Number of Participants With Objective Response (OR)|Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.||participants|||Number
110537|NCT00729833|Secondary|Number of Participants With Anti-Drug Antibodies (ADA)|Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.|0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)|ADA Analysis Set: Participants who started treatment with study medication and provided at least 1 on-study ADA sample. Due to early termination of the study, ADA samples were not assayed.|||||
110538|NCT00729833|Secondary|Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib||24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
110539|NCT00729833|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib||0.5 hour predose on Day 1 of Cycle 2|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
110540|NCT00729833|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib|AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).|0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
110541|NCT00729833|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||hours||Full Range|Median
110542|NCT00729833|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
110543|NCT00729833|Secondary|Plasma Decay Half-Life (t1/2) of Figitumumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||hours||Standard Deviation|Mean
110544|NCT00729833|Secondary|Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab|AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
110545|NCT00729833|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||milligram*hour/milliliter (mg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
112399|NCT00712335|Secondary|Sputum IFN-gamma/IL-5 Ratios|Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.|24 weeks|ITT and PP were used for analysis.||ratio||Standard Deviation|Mean
110546|NCT00729833|Secondary|Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab||0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4|Pharmacokinetic (PK) Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.||milligram/liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
110547|NCT00729833|Secondary|Percentage of Participants With Blood Chemistry Laboratory Test Abnormality|Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication; n=number of participants evaluable for this outcome measure, respectively.||percentage of participants|||Number
110548|NCT00729833|Secondary|Percentage of Participants With Hematologic Laboratory Test Abnormality|Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
110549|NCT00729833|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.||percentage of participants|||Number
110550|NCT00729833|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|"Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (>=) 7 days delay in administration of Cycle 2.~Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Baseline up to the end of Cycle 1 (each cycle=3 weeks)|Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.||participants|||Number
110551|NCT00729807|Secondary|Progression Time in Patients|To observe the time to progression in these patients. However, in the six patients treated they either all had progression of disease or stable when they came off study (i.e., the drug did not work, there was no basis to collect the data to time to progression (they went on to different treatments or hospice.) One patient was inevaluable due to going on hospice, four had disease progression disease and one had stable disease and patients must come off per protocol if they do not show a response to the drug.|pre- to post-treatment||02/2017||||
110552|NCT00729807|Secondary|Pre- and Post-treatment Changes in the Concentration of S100B and p21 in Tumor Biopsy Samples|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actuallyly treated.|pre- and pos-treatment||02/2017||||
110553|NCT00729807|Secondary|Serial Serum S100B Levels|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actually treated.|Days 3, 8, and 12 of Cycles 1 and 2||02/2017||||
110554|NCT00729807|Secondary|Wild-type p53 and S100B Status at Baseline|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotensions and hypoglycemia in the small cohort of patients actually treated.|Baseline||||||
110555|NCT00729807|Primary|CR, PR, Stable Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum of the longest diameter since the treatment started. (Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, J., Van Glabbeke, M., van Oosterom, A.T., Christian, M.C., Gwyther, S.G. (2000) J Natl Cancer Inst 92, 205-16)|Every 6-8 weeks|||participants|||Number
110556|NCT00729781|Primary|Safety|Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.|During 12-week original study and at long-term follow-up of 11 months or longer|All enrolled subjects' adverse events were collected.||events|||Number
110557|NCT00729781|Primary|Cosmetic Improvement|"An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global Aesthetic Improvement Scale (GAIS; relative scale from Worse to Very much improved). If the post-treatment photograph was not correctly identified, that procedure will receive a “worse” on the rating scale."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.||participants|||Number
110558|NCT00729781|Primary|Functional Improvement|"Functional improvement was defined as a subject who achieves both 1) an improvement in the physical condition of the collapsed nasal valve as evidenced by an increase of >= 10% in the change in volume during inspiration as measured by Vectra 3D photography from baseline to 12 weeks post-procedure; and 2) a reduction of at least 30% in the symptoms of nasal obstruction as measured by the Nasal Obstruction Symptom Evaluation Scale (NOSE) scale (5 questions with 0-4 scale from Not a problem to Severe problem, possible score 0-100 via raw score × 5) from baseline to 12 weeks post-procedure."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.||participants|||Number
110559|NCT00729690|Secondary|Passive Knee Flexion|Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion).|PostOp day 2|All Completed Patients were used||Degrees||Standard Deviation|Mean
110560|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 12 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|12 hours Post dose|All Completed Patients||Area (NRS*hr)||Standard Deviation|Mean
110561|NCT00729690|Secondary|Active Knee Flexion|The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2|PostOp day 2|All completed patients used.||Degrees||Standard Deviation|Mean
110562|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 24 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|24 hours|All Completed Patients were included in the analysis.||Area (NRS*hr)||Standard Deviation|Mean
110563|NCT00729677|Post-Hoc|Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy|Number of participants on 2-drug (5HT3 inhibitor plus steroid) versus 3 drug (2-drug regimen plus an NK-1 inhibitor) who reported nausea during the first cycle of chemotherapy. 5HT-3 inhibitors included ondansetron, dolasetron, granisetron, and palonosetron. The NK-1 inhibitor was aprepitant. The steroid was dexamethasone.|Week 1|||participants|||Number
110564|NCT00729677|Primary|Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy|Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy|week 1|||participants|||Number
110565|NCT00729677|Primary|Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index – Emesis Scale at 5-7 Days|Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.|Week 1|this data was not collected|||||
110566|NCT00729677|Primary|Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy||Week 1 of FOLFOX chemotherapy|||percentage of participants|||Number
110567|NCT00729651|Post-Hoc|Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||ng/ml||Standard Deviation|Mean
110568|NCT00729651|Post-Hoc|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||participants|||Number
110569|NCT00729651|Secondary|Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment||Baseline and 16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||Percentage Change Serum PTH||95% Confidence Interval|Least Squares Mean
110570|NCT00729651|Primary|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.||participants|||Number
110571|NCT00729612|Secondary|Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0|The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics|Up to 5 years|Grade 3 and 4||patients|||Number
110572|NCT00729612|Secondary|Overall Survival|Will be analyzed using a Kaplan-Meier methods.|Up to 5 years|||months||95% Confidence Interval|Median
110573|NCT00729612|Secondary|Progression Free Survival|Progression free survival of Abraxane/Carboplatin in bevacizumab in the eligible patients.|Up to 5 years|||months||95% Confidence Interval|Median
110574|NCT00729612|Primary|Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.|Will be estimated with an exact binomial. Response rate is overall response rate (CR+PR) as defined by RECIST criteria|Up to 5 years|||percentage of patients||95% Confidence Interval|Number
110575|NCT00729560|Primary|DCI-IPG Measurements in Blood and Urine|zero participants analyzed, no assays performed|2 years||||||
110605|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal|Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
110639|NCT00728845|Primary|Recommended Phase II Dose of Hydroxychloroquine and Carboplatin When Administered With Paclitaxel and Bevacizumab (Phase I)||Phase I portion of study|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
110576|NCT00729521|Primary|Emergency Department and In-patient Hospitalization for Fall Injury|Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.|2007-2008; 2010-2011|Population of residents aged 65 and older for participating communities in each study arm for 2007-2008 baseline period and 2010-2011 follow-up period.||Fall Injury Rate per 100 person years||95% Confidence Interval|Number
110577|NCT00729482|Secondary|Toxicity Profiles (According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0)||up to 24 weeks|||participants|||Number
110578|NCT00729482|Secondary|Overall Survival||1 year|||Months||95% Confidence Interval|Median
110579|NCT00729482|Secondary|Response Rate||2years|51 patients were available for response assessments.||percentage of participants|||Number
110580|NCT00729482|Primary|Progression-free Survival Rate at 4-month (16 Weeks)||4 months (16 weeks)|||percentage of participants|||Number
110581|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
110582|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
110583|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.||participants|||Number
110584|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)||4 weeks|ITT||pH||Standard Deviation|Mean
110585|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.||participants|||Number
110586|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)||4 weeks|ITT||pH||Standard Deviation|Mean
110587|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||12 weeks|ITT; LOCF||participants|||Number
110588|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)||12 weeks|ITT; LOCF||pH||Standard Deviation|Mean
110589|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)||12 weeks|ITT; LOCF||percentage of superficial cells||Standard Deviation|Mean
110590|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)||12 weeks|ITT; LOCF||percentage of parabasal cells||Standard Deviation|Mean
110591|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||12 weeks|ITT; LOCF||participants|||Number
110592|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
110593|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
110594|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)||12 weeks|ITT; LOCF||pH||Standard Deviation|Mean
110595|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)||12 weeks|ITT; LOCF||percentage of superficial cells||Standard Deviation|Mean
110596|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)||12 weeks|ITT; LOCF||percentage of parabasal cells||Standard Deviation|Mean
110597|NCT00729365|Secondary|We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.||year 1, 3, 5 and after the washout phase (5years and 1month)||||||
110598|NCT00729365|Primary|Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.||at 3months and then every 6months during the 5years of the study||||||
110599|NCT00729326|Secondary|Episodes of Hypoglycemia (Overall)|Number of episodes of hypoglycemia experienced overall during the study|4 weeks and 8 weeks|All patients in FAS||episodes of hypoglycemia|||Number
110600|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Overall)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 weeks and 8 weeks|All patients in FAS||Percentage of patients|||Number
110601|NCT00729326|Secondary|Episodes of Hypoglycemia (Week 4 to Week 8)|Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study|8 weeks|All patients in FAS||episodes of hypoglycemia|||Number
110602|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|8 weeks|All patients in FAS||Percentage of patients|||Number
110603|NCT00729326|Secondary|Episodes of Hypoglycemia (Baseline to Week 4)|Number of episodes of hypoglycemia experienced during the first 4 weeks of the study|4 weeks|Full analysis set||episodes of hypoglycemia|||Number
110604|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 Weeks|All patients in FAS||Percentage of patients|||Number
110606|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC After the Morning Meal|Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
110607|NCT00729326|Secondary|Change in Postprandial Insulin AUC Excursion After the Morning Meal|Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
110608|NCT00729326|Secondary|Change in Postprandial Insulin AUC After the Morning Meal|Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
110609|NCT00729326|Secondary|Change in Postprandial C-peptide AUC Excursion After the Morning Meal|Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||nmol*hours/L||Standard Error|Least Squares Mean
110610|NCT00729326|Secondary|Change in Postprandial C-peptide AUC After the Morning Meal|Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||nmol*hours/L||Standard Error|Least Squares Mean
110611|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC Excursion After the Morning Meal|Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||mg*hours/dL||Standard Error|Least Squares Mean
110612|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC After the Morning Meal|Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||mg*hours/dL||Standard Error|Least Squares Mean
110613|NCT00729326|Secondary|Change in Postprandial Glucagon AUC Excursion After the Morning Meal|Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
110614|NCT00729326|Secondary|Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal|Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward||pmol*hours/L||Standard Error|Least Squares Mean
110615|NCT00729326|Secondary|Change in Fasting Blood Glucose After the Morning Meal|Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward||mg/dL||Standard Error|Least Squares Mean
110616|NCT00729326|Secondary|Change in Two-hour Postprandial Glucose After the Morning Meal|Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward||mg/dL||Standard Error|Least Squares Mean
110617|NCT00729326|Primary|Change in Time-averaged Glucose During a 24 Hour Period|Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).|baseline and 8 Weeks|The number of patients was determined based on 90% powering of the study. Analyses were based on data from all randomized patients receiving at least one dose of the study drug and completing at least one treatment period. For each patient, the missing data for some time points were imputed by linear interpolation.||mg/dL||Standard Error|Least Squares Mean
110618|NCT00729248|Primary|CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors|CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and > 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and > 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.|3 months|For each arm, blood samples from 5 donor/recipient pairs (i.e., 10 participants) were used.||Percentage of Control Cells||Standard Deviation|Mean
110619|NCT00728988|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP)|C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents.|Baseline, 8 hours, 24 hours and 30 days|FAS. N = number of subjects with non-missing values at baseline.||percent change in CRP||Standard Error|Least Squares Mean
110638|NCT00728845|Primary|Overall Response (Phase II)||Treatment start date to date of best response|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
110620|NCT00728988|Secondary|Percentage of Participants With Elevated Myoglobin|Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.||percentage of participants|||Number
110621|NCT00728988|Secondary|Percentage of Participants With Elevated Troponin I|Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.||percentage of participants|||Number
110622|NCT00728988|Secondary|Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)|CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.||percentage of participants|||Number
110623|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100.|24 hours post PCI|FAS.||percentage of participants|||Number
110624|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100.|8 hours post PCI|FAS.||percentage of participants|||Number
110625|NCT00728988|Primary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)|Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded.|30 days post PCI|Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF).||percentage of participants|||Number
110626|NCT00728962|Secondary|Crestal Bone Regression||four years||||||
110627|NCT00728962|Primary|Patients With Implants Achieving Osseous Integration|Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|1 year|total number of patients enrolled in the study was used for primary outcome analysis||participants|||Number
110628|NCT00728923|Secondary|Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.|Patients given HAM-D (Hamilton Depression Scale), a measure of depressive symptoms. For the HAM-D the minimum units are 0 and Maximum units on the total scale are 50. The higher the number on the HAM-D, the more severe the symptoms. Response was defined as at least a 30% reduction on the HAM-D.|12 weeks|||participants|||Number
110629|NCT00728923|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 30% reduction on the YBOCS.|12 weeks|||participants|||Number
110630|NCT00728910|Primary|Post-prandial Triglyceride Incremental Area Under the Curve (iAUC)|Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)|4 weeks, 12 weeks, 22 weeks|subjects completing any phase of treatment for whom complete post-prandial data were available||mg/dl*h||95% Confidence Interval|Mean
110631|NCT00728910|Primary|Apo-A1 Production Rate|The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.|4 weeks, 12 weeks and 22 weeks|Patients who completed any phase of treatment for whom kinetic data were available||mg/kg/day||95% Confidence Interval|Mean
110632|NCT00728910|Primary|The Apolipoprotein A-I Fractional Catabolic Rate (FCR)|After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.|4 weeks, 12 weeks and 22 weeks|Patients who completed any of the three phases for whom the kinetic study data was available for any phase of treatment||pools/day||95% Confidence Interval|Mean
110633|NCT00728884|Secondary|Crestal Bone Resorption||four years||12/2016||||
110634|NCT00728884|Primary|Osseous Integration||one year|total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.||participants|||Number
110635|NCT00728845|Secondary|Overall Survival (Phase II)||Treatment start date to date of death|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
110636|NCT00728845|Secondary|Progression-free Survival at 1 Year (Phase II)||Treatment start date to 1 year|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
110637|NCT00728845|Secondary|Time to Progression (Phase II)||Treatment start date and date of progression|Study was terminated early and insufficient data were collected to assess this outcome measure.|||||
110641|NCT00728754|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).||millimeters|Participants|Standard Error|Mean
110642|NCT00728728|Secondary|Clinical Global Impressions (CGI) Scale|The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|Missing data for a total of 5 participants for the CGI.||score||Standard Error|Mean
110643|NCT00728728|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||total score||Standard Error|Mean
110644|NCT00728728|Secondary|The Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period.|||total score||Standard Error|Mean
110645|NCT00728728|Primary|Scale for the Assessment of Negative Symptoms(SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||total score||Standard Error|Mean
110646|NCT00728728|Primary|Brief Assessment of Cognition in Schizophrenia (BACS)|The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||Z score||Standard Error|Mean
110647|NCT00728728|Primary|University of California Performance-based Skills Assessment (UPSA)|The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||total score||Standard Error|Mean
110648|NCT00728728|Primary|MATRICS Consensus Cognitive Battery (MCCB)|"The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.~The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance."|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|||T score||Standard Error|Mean
110649|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Tmax|Time to maximum plasma concentration(Tmax; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.||hours||Standard Deviation|Mean
110650|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Cmax|Maximum drug concentration in plasma, determined directly from individual concentration-time data (Cmax)|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants as 'per protocol'. Form V group lost a particpant during wash-out period due to death in the family.||ng/mL||Standard Deviation|Mean
110651|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-∞|Area under the drug concentration-time curve from time zero to infinity (AUC0-∞; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.||ng*hr/mL||Standard Deviation|Mean
110652|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-τ|Area under the drug concentration-time curve from time zero to time t, where t is the last timepoint with a drug concentration ≥ lowest obtainable quantification (AUC0-τ; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.||ng*hr/mL||Standard Deviation|Mean
110727|NCT00727714|Primary|Changes in Lung Function Measurements During One Work Shift (6-8h)|Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity|baseline and 6-8h|||Litres||Standard Deviation|Mean
110653|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½|Mean terminal half-life (t½; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from the half-life analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.||hours||Standard Deviation|Mean
110654|NCT00728689|Secondary|Number of Study Participants Who Tolerated a Single Dose of ST-246 Form I vs. Form V as Determined by No Clinically Significant Changes in Safety Parameters|"Evaluated safety parameters included:~physical examination/vital signs~electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)~laboratory safety tests (hematology, chemistry, urinalysis)~adverse events For a), b) and c), summary statistics (mean,SD, median, minm, maxm)for values, and changes from baseline(Day 1 pre-dose) to each timepoint, were measured and compared to laboratory normal reference ranges. Values for a)- d) were assigned grades according to DAIDS AE Grading Table. Any Grade of 3 or higher was considered severe and significant."|4 weeks|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.||participants|||Number
110655|NCT00728494|Primary|The Number of Participants Who Relapsed at 6 Months Post-treatment|Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment|Measured at end of treatment and 6 months post-treatment|||Participants|||Number
110656|NCT00728494|Primary|The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment|Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment|Measured at 6 months post-treatment|||Participants|||Number
110657|NCT00728494|Secondary|Average Dosage of Rebetol|Rebetol dosage was expressed in milligrams per kilogram of body weight per day.|Up to 48-week treatment duration|||mg/kg/day||Standard Deviation|Mean
110658|NCT00728494|Secondary|Average Dosage of PegIntron|Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week|Up to 48-week treatment duration|||micrograms/kg/week||Standard Deviation|Mean
110659|NCT00728494|Secondary|Average Length of Treatment|Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.|Maximum 48-week treatment duration|||Participants|||Number
110660|NCT00728494|Primary|The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C|Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program|At the end of the 48-week treatment period|||Participants|||Number
110661|NCT00728481|Primary|Symptomatic Response to Treatment|"Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30).~Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study."|Baseline, 6 months|||Participants|||Number
110662|NCT00728481|Secondary|Participants With Presence of Erosive Esophagitis at Six Month Endoscopy||Baseline, 6 months|||participants|||Number
110663|NCT00728481|Secondary|Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy|Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.|Baseline, 6 months|||participants|||Number
110664|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.|Baseline, 6 months|The analysis population for this item only included subjects with a non-significant histologic response. Subjects were considered to have a histological response to treatment if both sets of 6-month biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.||Participants|||Number
110665|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.|Baseline, 6 months|The analysis population includes only subjects with a histologic response. Subjects were considered to have a histological response to treatment if both sets of biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.||Participants|||Number
110666|NCT00728481|Primary|Histological Response to Treatment|Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.|Baseline, 6 months|||Participants|||Number
110667|NCT00728416|Secondary|Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.||Units on a scale||95% Confidence Interval|Least Squares Mean
110684|NCT00728130|Secondary|The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.|Pathological detection of carcinoma within each of the dissected nodes reported as node groups.|Post surgical time point|||carcinoma positive nodes||Standard Deviation|Mean
110728|NCT00726622|Secondary|Bowel and Stoma Function||Up to 5 years post surgery||||||
110668|NCT00728416|Primary|Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.||Units on a scale||95% Confidence Interval|Least Squares Mean
110669|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 31 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
110670|NCT00728260|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database – All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 doses|||Number
110671|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 0 up to Day 30 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
110672|NCT00728182|Other Pre-specified|Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 with ruptured aneurysms was compared in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30|||No. of participants with mRS 0-2|||Number
110673|NCT00728182|Other Pre-specified|National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for participants with ruptured aneurysms in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30|All subjects who entered the study with a ruptured aneurysm, who received study drug and outcome assessment at Day 30.||No. of participants with NIHSS 0-1|||Number
110674|NCT00728182|Other Pre-specified|Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
110675|NCT00728182|Other Pre-specified|Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
110676|NCT00728182|Other Pre-specified|Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
110677|NCT00728182|Other Pre-specified|Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose (pre-specified subgroup analysis)|Enrolment, Days 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
110678|NCT00728182|Secondary|Modified Rankin Scale (mRS).|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.|Enrolment, Day 30|All patients who received study drug and an outcome assessment at Day 30||No. of participants with mRS 0-2|||Number
110679|NCT00728182|Secondary|National Institutes of Health Stroke Scale (NIHSS).|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.|Enrolment, Day 30|All patients who received study drug and outcome assessment at Day 30.||No. of participants with NIHSS 0-1|||Number
110680|NCT00728182|Secondary|Volume of New DWI Lesions (MRI)|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
110681|NCT00728182|Secondary|Number of New FLAIR Lesions (MRI)|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI scan at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
110682|NCT00728182|Secondary|Number of New DWI Lesions (MRI)|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.|Enrolment, Day 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.||Lesions||Standard Deviation|Mean
110683|NCT00728182|Primary|Volume of New FLAIR Lesions(MRI)|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose|Enrolment, Days 2-4|All study patients who received study drug and an analyzable MRI at 12-95 hours postdose.||mm^3||Standard Deviation|Mean
110729|NCT00726622|Secondary|Bowel Function||Up to 5 years post surgery||||||
110685|NCT00728130|Primary|the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.|The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.|Post Surgical Time point|||nodes||Standard Deviation|Mean
110686|NCT00727961|Primary|Number of Participants With Progression|Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||Participants|||Number
110687|NCT00727961|Primary|Number of Participants With Stabilization|All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||Participants|||Number
110688|NCT00727961|Primary|Number of Participants With Partial Response|Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||Participants|||Number
110689|NCT00727961|Secondary|Mean Survival Time During the Study|Mean time to the occurrence of death|from the beginning of study drug administration up to 18 months|||days||95% Confidence Interval|Mean
110690|NCT00727961|Secondary|Median Time to Progression|Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|from the beginning of study drug administration up to 4 weeks after chemotherapy completed|||days||95% Confidence Interval|Median
110691|NCT00727961|Secondary|Mean Time to Positive (Partial) Treatment Response Achievement|"Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.~Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions."|from the beginning of study drug administration up to 4 weeks after chemotherapy completed|||days||Standard Deviation|Mean
110692|NCT00727961|Primary|Number of Participants With Complete Response|Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed|||participants|||Number
110693|NCT00727909|Primary|Percentage of Participants That Selected a Particular Type of Hearing Aid||At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)|||percentage of participants|||Number
110694|NCT00727857|Secondary|Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration|The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||nmol/L||Standard Error|Least Squares Mean
110695|NCT00727857|Secondary|Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration|The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110696|NCT00727857|Secondary|Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration|The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110697|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Size|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nm||Standard Error|Least Squares Mean
110698|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110699|NCT00727857|Secondary|Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration|The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
110700|NCT00727857|Secondary|Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration|The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
110701|NCT00727857|Secondary|Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration|The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
110702|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Size|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24|||nm||Standard Error|Least Squares Mean
110703|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Concentration|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24|||μmol/L||Standard Error|Least Squares Mean
110704|NCT00727857|Secondary|Change From Baseline in Very Small Low Density Lipoprotein Concentration|The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110730|NCT00726622|Secondary|Quality of Life and Sexual Function||Up to 5 years post surgery||||||
110731|NCT00726622|Secondary|Overall Survival||Up to 5 years post surgery||||||
110705|NCT00727857|Secondary|Change From Baseline in Small Low Density Lipoprotein Concentration|The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110706|NCT00727857|Secondary|Change From Baseline in Medium-Small Low Density Lipoprotein Concentration|The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110707|NCT00727857|Secondary|Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration|The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110708|NCT00727857|Secondary|Change From Baseline in Large Low Density Lipoprotein (L3) Concentration|The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nmol/L||Standard Error|Least Squares Mean
110709|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Size|The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.|Baseline and Week 24|||nm||Standard Deviation|Least Squares Mean
110710|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Concentration|The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||nmol/L||Standard Error|Least Squares Mean
110711|NCT00727857|Secondary|Change From Baseline in Triglycerides|The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
110712|NCT00727857|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
110713|NCT00727857|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
110714|NCT00727857|Secondary|Change From Baseline in Total Cholesterol|The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
110715|NCT00727857|Secondary|Change From Baseline in Adiponectin|The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mcg/ml||Standard Error|Least Squares Mean
110716|NCT00727857|Secondary|Median Percent Change From Baseline in High Sensitivity C-reactive Protein|Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: [(Week 24 - baseline levels)/baseline]*100|Baseline and Week 24|||percent||Full Range|Median
110717|NCT00727857|Secondary|Change From Baseline in Homeostasis Model Assessment - Insulin Resistance|The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||percent of insulin resistance||Standard Error|Least Squares Mean
110718|NCT00727857|Secondary|Change From Baseline in Fasting Insulin|The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||μIU/mL||Standard Error|Least Squares Mean
110719|NCT00727857|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit||mg/dL||Standard Error|Least Squares Mean
110720|NCT00727857|Primary|Percent Change From Baseline in Glycosylated Hemoglobin|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
110721|NCT00727844|Primary|Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months.||Sputum smear conversion or max 4 months after the start of Linezolid therapy.|||participants|||Number
110722|NCT00727740|Primary|Reduction in Pancreatitis Rate|Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.|24 hours|||percentage of participants with PEP|||Number
110723|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h||0-32h|||ng/Litre||Full Range|Median
110724|NCT00727714|Secondary|Changes in FeNO Measurements Between Baseline (0h) and 32 h||0-32h|||ppb||Full Range|Median
110725|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)||Baseline and 6-8h|||ng/Litre||Full Range|Median
110726|NCT00727714|Secondary|Changes in FeNO Measurements During One Shift (6-8h)||baseline and 6-8h|Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements||ppb||Full Range|Median
110734|NCT00726622|Secondary|Operative Times|Open to close operative time.|During surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||minutes||Standard Deviation|Mean
110735|NCT00726622|Secondary|Use of Pain Medication|The number of days patients received parenteral narcotics post-surgery were counted.|Up to 5 years post surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||days||Standard Deviation|Mean
110736|NCT00726622|Secondary|Length of Stay|The mean number of days required post-surgery to the when the patient was released from the hospital wascalculated.|Up to 5 years post surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||days||Standard Deviation|Mean
110737|NCT00726622|Secondary|Circumferential Margin > 1 mm|The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
110738|NCT00726622|Secondary|Negative Distal Resected Margin|The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binoimial 95% confidence intervals.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
110739|NCT00726622|Secondary|Completeness of Total Mesorectal Excision (Complete or Nearly Complete)|"Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.~The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI."|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
110740|NCT00726622|Primary|Non-Inferiority Analysis Between Laparoscopic-assisted Resection and Open Rectal Resection for Rectal Cancer.|"The primary aim is to test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection. The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.~Primary endpoint parameters:~Circumferential margin > 1 mm~Negative distal margin~Completeness of total mesorectal excision (TME) A complete TME is defined as a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat. A nearly complete TME is defined as a rectal resection specimen where the mesentery is all present, without coning or missing fat. A <5 mm deep defect may be present in the envelope covering mesenteric fat."|At time of Surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.||percentage of participants||95% Confidence Interval|Number
110741|NCT00726609|Primary|Number of Participants Reporting Adverse Drug Reactions.|"The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:~Mild: The abnormality, symptom or event is noticed but well tolerated.~Moderate: Symptoms impair normal activities and may require intervention.~Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required."|Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.|||Participants|||Number
110742|NCT00727649|Secondary|Fecal Incontinence Severity Index Score, FISI|The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.|baseline, 4 week and 12 weeks|||units on a scale||Standard Deviation|Mean
110743|NCT00727649|Primary|Percentage of Bowel Movements With Incontinence|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.|4 weeks|||percentage of incontinent bowel movement||Standard Deviation|Mean
110744|NCT00727649|Primary|7-day Bowel Diary, Number of Fecal Incontinence Episodes|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.|6 weeks and 12 weeks|||Fecal incontinence episodes||Standard Deviation|Mean
110745|NCT00727636|Primary|Antibody Titer to HPV 18|Geometric mean titer (95%CI)|Month 7|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
110750|NCT00727597|Primary|Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)|"Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons:~To resolve a Grade 3 or 4 Adverse Event~The subject experienced a virologic failure (as defined in section 3.6.2)~The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue~The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"|96 weeks|||participants|||Number
110751|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Right Leg|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||pounds||Standard Deviation|Mean
110752|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Left Leg.|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||pounds||Standard Deviation|Mean
110753|NCT00727571|Secondary|Physical Performance: Grip Strength|Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||pound-force||Standard Deviation|Mean
110754|NCT00727571|Secondary|Physical Performance: Time to Rise From Sitting to Standing|Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||seconds||Inter-Quartile Range|Median
110755|NCT00727571|Secondary|Physical Performance: Duration Walked or Wheeled at Each Visit|The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||minutes||Standard Deviation|Mean
110756|NCT00727571|Secondary|Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||feet per minute||Standard Deviation|Mean
110757|NCT00727571|Secondary|Estimated Glomerular Filtration Rate (GFR) for Participants With CKD|Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x [Serum creatinine]^-1.154 x [Age]^-0.203 x [0.742 if patient is female] x [1.210 if patient is black]. 2. Cockcroft-Gault formula: GFR = (140-age) * (Weight in kg) * (0.85 if female) / (72 * Serum Creatinine).|Weeks 1, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||mL/min/1.73 m^2||Standard Deviation|Mean
110758|NCT00727571|Secondary|Percentage of Participants With Anemia Related Conditions at Baseline|"The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative.~Vitamin B12 and folate deficiency based on standard laboratory ranges."|Baseline|Enrolled patients with anemia||Percentage of participants|||Number
110759|NCT00727571|Secondary|Number of Participants With Anemia|Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.|Baseline|All enrolled patients with available anemia lab results.||participants|||Number
110760|NCT00727571|Primary|Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."||feet||Inter-Quartile Range|Median
110761|NCT00727558|Secondary|Inferior Region Corneal Staining|National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=243).||Units on a scale||Standard Error|Least Squares Mean
110762|NCT00727558|Secondary|Initial Comfort|"Rating of comfort immediately when you first put them on using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent."|at 1 week|Analysis includes participants who completed the study per protocol and had no missing data (n=240).||Units on a scale||Standard Error|Least Squares Mean
110763|NCT00727558|Secondary|End of Day Comfort|Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).||Units on a scale||Standard Error|Least Squares Mean
110810|NCT00727025|Primary|Time to Perform Wound Closure|Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture|intraoperatively|those who completed application of devices intraoperatively||minutes||Standard Deviation|Mean
110764|NCT00727558|Secondary|How Comfortable Eyes Feel at the End of the Day|"Rating of How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable."|at 1 week wear|Analysis includes participants who completed the study per protocol and had no missing data.||Units on a scale||Standard Error|Least Squares Mean
110765|NCT00727558|Secondary|Overall Handling|Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).||Units on a scale||Standard Error|Least Squares Mean
110766|NCT00727558|Primary|Measured Limbal Hyperemia|Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|at 1 week of wear.|Analysis includes participants who completed the study per protocol and had no missing data (n=243).||Units on a scale||Standard Error|Least Squares Mean
110767|NCT00727558|Primary|Overall Comfort|Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear.|Analysis includes participants who completed the protocol and had no missing data (n=240)||Units on a scale||Standard Error|Least Squares Mean
110768|NCT00727506|Primary|Number of Participants With Dose Limiting Toxicities - Phase I Part||From randomization till data cut-off (10 Jun 2009), with a mean treatment duration of 51 days|||participants|||Number
110769|NCT00727506|Secondary|Objective Tumor Response (OBR) in Phase I|OBR is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review.|From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.|Patients treated in Phase I part||participants|||Number
110770|NCT00727506|Secondary|Objective Tumor Response (OBR) in Phase II|OBR is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review. Only data collected until cut-off date May 12, 2011 were considered.|From randomization to until the date of first documented progression or data cutoff on May 12, 2011, whichever came first, with a mean treatment duration of 91 days|RS||participants|||Number
110771|NCT00727506|Primary|Progression-free Survival (PFS-6) at Six Months - Phase II Part|"PFS-6 is defined as probability of patients surviving to six months after randomization without progression. Disease progression was evaluated by an independent review committee and by the investigators, independently. The evaluation by the independent review committee was used for the primary outcome measure. The measurement Number the estimated PFS-6 value from the Kaplan-Meier curve of PFS."|At six months after randomization|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment in the Phase II part of the trial.||probablity of survival||95% Confidence Interval|Number
110772|NCT00727402|Primary|Cumulative Incidence of Corneal Inflammatory Events|Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.|annual|||annual incidence per 100 subjects|Participants|95% Confidence Interval|Mean
110773|NCT00727337|Primary|Words-in-Noise Test|Monosyllabic words (NU-6 female version) with a carrier phrase were presented auditory only in a multitalker babble.The participant is asked to repeat the last word of each phrase. The total number of correct words is input into the Spearman-Karber equation to derive a 50% point. This is the signal-to-noise ratio in dB that an individual requires to get 50% of the words correct. This test was completed at baseline and follow up visits.|Baseline and at 6 month follow up|||dB SNR||Standard Deviation|Mean
110774|NCT00727337|Secondary|Hearing Handicap Inventory for the Elderly||This outcome measure will assess changes from aided baseline to aided assessments made immediately and at six-months post treatment.||||||
110775|NCT00727337|Secondary|Abbreviated Profile of Hearing Aid Benefit||This outcome measure will assess changes from aided baseline to aided assessments made immediately and at six-months post treatment.||||||
110776|NCT00727311|Primary|Number of HCV-RNA Negative Participants at Follow-up|HCV-RNA was measured by PCR.|24 weeks post-treatment (Weeks 48 or 72, depending on genotype)|Number of participants with results at the 6 month follow-up examination||Participants|||Number
110777|NCT00727311|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT|24 weeks post-treatment (Week 48 or 72, depending on genotype)|Number of evaluable participants with follow-up information||Participants|||Number
110778|NCT00727311|Primary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA~negativity from baseline to Week 12"|Treatment Week 12|Number of evaluable participants at 12 weeks of treatment||Participants|||Number
110779|NCT00727311|Primary|Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)|HCV-RNA level was measured by polymerase chain reaction (PCR).|24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6|Number of evaluable participants at EoT||Participants|||Number
110780|NCT00727298|Secondary|Clinicians' Impression of Therapeutic Efficacy|Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.|Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.||Percentage of Participants|||Number
110781|NCT00727298|Secondary|Clinicians' Impression of Disease Severity From Baseline to Week 102|Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.|Baseline, Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.||Percentage of Participants|||Number
110811|NCT00727025|Secondary|Patient Postoperative Incisional Comfort|Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable|10 days|||units on a scale||Standard Deviation|Mean
145405|NCT00424528|Secondary|Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint||2 Weeks|||Liters||Standard Deviation|Mean
110782|NCT00727298|Primary|Number of Participants Experiencing at Least One Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.|Baseline to Month 24|The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.||Participants|||Number
110783|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
110784|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
110785|NCT00727272|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.||ng/mL||Standard Deviation|Mean
110786|NCT00727259|Primary|Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months|Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).|The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.|Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.||satisfaction rating from 0-7||Standard Deviation|Mean
110787|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Ptosis)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.||units on a scale||Standard Deviation|Mean
110788|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Double Vision)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.||units on a scale||Standard Deviation|Mean
110789|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Negative Inspiratory Force. NIF is a measurement of respiratory muscle strength and ventilator reserve. NIF is represented by centimeters of water pressure (cmH2O). A normal NIF measurement is negative 60 cmH2O, or as 100% predicted value.|16 weeks|Comparison of NIF at the Last Visit Between Eculizumab and Placebo Cohorts.||percentage of predicted||Standard Deviation|Mean
110790|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Forced Vital Capacity|16 weeks|Comparison of FVC at the Last Visit Between Eculizumab and Placebo Cohorts.||percentage of predicted||Standard Deviation|Mean
110791|NCT00727194|Secondary|Change From Baseline in the QoL Instrument, SF-36.|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (physical functioning, role-physical, bodily pain, general health, mental health, role-emotional, social functioning and vitality) as well as psychometrically-based physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group. The lower the score the more disability; the higher the score the less disability. Norm-based scoring involving a linear T-score transformation method was used so that scores for each of the health domain scales and component summary measures have a mean of 50 and a standard deviation of 10 based on the 1998 US general population. Thus, scores above and below 50 are above and below the average, respectively, in the 1998 US general.|16 weeks|Comparison of SF-36 at the Last Visit Between Eculizumab and Placebo Cohorts.||units on a scale||Standard Deviation|Mean
110792|NCT00727194|Secondary|Change From Baseline in the MG-Activity of Daily Living Profile (MG-ADL)|The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living (ADL) in MG patients. The 8 items of the MG-ADL were derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 – 24. MG-ADL was to be performed at every study visit. The recall period for MG-ADL was since the preceding study visit (1 or 2 weeks).|16 weeks|Comparison of MG Activities of Daily Living (Total score) at the Last Visit Between Eculizumab and Placebo Cohorts.||units on a scale||Standard Deviation|Mean
110793|NCT00727194|Secondary|Change From Baseline in the MGFA Post-Intervention Status (PIS)|The MGFA PIS is designed to assess the clinical state of MG patients at any time after treatment of MG is initiated. Change in status categories of Improved, Unchanged, Worse, Exacerbation, and Died of MG was to be assessed and recorded at every visit from Visits 3 to 24 (Weeks 1 to 16). Minimal manifestations were to be assessed at these visits.|16 weeks|||participants|||Number
110794|NCT00727194|Secondary|Mean Change From Baseline in QMG Total Score|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The Myasthenia Gravis Foundation of America task force has recommended that the QMG score be used in prospective studies of therapy for MG. The QMG scoring system consists of 13 items. Each item is graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0-39.|16 weeks|||units on a scale||Standard Deviation|Mean
110795|NCT00727194|Primary|Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG.|16 weeks|||percentage of patients|||Number
110796|NCT00727090|Secondary|Glasgow Coma Scale|Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)|48 hours||||||
110797|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 48 Hours||48 hours|||mMol/L||Standard Deviation|Mean
110798|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 36 Hours||36 hours|||mMol/L||Standard Deviation|Mean
110799|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 24 Hours||24 hours|||mMol/L||Standard Deviation|Mean
110800|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 18 Hours||18 hours|||mMol/L||Standard Deviation|Mean
110801|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 12 Hours||12 hours|||mMol/L||Standard Deviation|Mean
110802|NCT00727090|Secondary|NIH Stroke Scale|Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).|48 hours||||||
110803|NCT00727090|Primary|Change in Serum Sodium From Baseline to 6 Hours||48 hours|Intention to treat||mMol/L||Standard Deviation|Mean
110804|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
110805|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status|Cmax is a measure of drug metabolism and is presented as least squares geometric mean with 90% Confidence Interval.Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
110806|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
110807|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|Cmax is a measure of drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
110808|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
110809|NCT00727064|Primary|Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status|Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
110812|NCT00727025|Primary|Scar Quality at 6 Months Postoperative|Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.|6 months|||units on a scale||Standard Deviation|Mean
110813|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 2|||mg/kg/h||Standard Deviation|Mean
110814|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 1|||mg/kg/h||Standard Deviation|Mean
110815|NCT00726999|Secondary|Side Effect Occurrence|The number of episodes of/occurrence of side effects was monitored in both groups.|First 10 days after surgery||||||
110816|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)|Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.|PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)|||mg/kg/h||Standard Deviation|Mean
110817|NCT00726986|Secondary|Safety|Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.|Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||participants|||Number
110818|NCT00726986|Secondary|Response Rate|"The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|reevaluated for response every 8 weeks|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||participants|||Number
110819|NCT00726986|Secondary|Median Overall Survival|Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||months||95% Confidence Interval|Median
110820|NCT00726986|Primary|Progression-free Survival(PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.||months||95% Confidence Interval|Median
110821|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
110822|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.||ng-hr/mL||Standard Deviation|Mean
110823|NCT00726895|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.||ng/mL||Standard Deviation|Mean
110824|NCT00726882|Secondary|Number of Participants With Serious Adverse Events Related to Study Procedures|Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|48 weeks|||participants|||Number
110825|NCT00726882|Primary|Persistence of Resistance-Associated Variants and Phenotypic Resistance|Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.|Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks|Resistance analyses included all participants who received ABT-333 in the previous study who had sufficient HCV RNA recovered from samples collected during this study for genotypic and phenotypic analysis to proceed. m, n = the number of evaluable participants for the analysis specified for M10-380 and M10-351, respectively.||participants|||Number
110827|NCT00726830|Primary|Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)|MDASI questionnaire completed on days 8, 15, and 22 after enrollment. The ‘primary success’ is defined as a 3-point reduction in pain score on the MDASI. Scores from baseline and from four weeks later compared using the MDASI average pain intensity on a scale of 0 (no pain) to 10 (worst pain).|28 days|No Analysis accomplished as there is not sufficient participant data to meet the study end points.|||||
110828|NCT00726752|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.|Up to 470 days of treatment plus 28-days follow-up|Safety analysis set was defined as all enrolled participants who received the study drug at least once in this study (same as the full analysis set:FAS).||participants|||Number
110829|NCT00726752|Secondary|Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 470 days|Anti-tumor response analysis set was defined as all participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug.||participants|||Number
110830|NCT00726752|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF|Prior to the initial dose (baseline) and Day 1 of Cycle 2|Pharmacodynamic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacodynamic blood sampling for at least 1 day.||percent||Full Range|Median
110831|NCT00726752|Secondary|Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ratio||Standard Deviation|Mean
110832|NCT00726752|Secondary|Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||hours||Full Range|Median
110833|NCT00726752|Secondary|Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 12 hours in this study.|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng*h/mL||Standard Deviation|Mean
110834|NCT00726752|Secondary|Multiple Dose: Maximum Observed Plasma Concentration (Cmax)|Cmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng/mL||Standard Deviation|Mean
110835|NCT00726752|Primary|Single Dose: Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||hours||Standard Deviation|Mean
110836|NCT00726752|Primary|Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||hours||Full Range|Median
110837|NCT00726752|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng*hr/mL||Standard Deviation|Mean
110838|NCT00726752|Primary|Single Dose: Maximum Observed Plasma Concentration (Cmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.||ng/mL||Standard Deviation|Mean
110839|NCT00726739|Secondary|Immune Response|Immune responses is be assessed by Delayed Type Hypersensitive (DTH) responses to LMI, IFN-γ production by CD8 T cells using the ELISPOT assay, and CD8 T cell binding to HLA-A2 multimers complexed with melanoma-derived peptides (pentamer analysis). DTH reactions are determined at 48 hours by measuring the largest diameter and right angle diameter of the area of induration and calculating the mean. DTH responses are recorded as present or absent but cannot be used as a quantitative measure of immune activation.|48 hours After Study Medication|||participants|||Number
110840|NCT00726739|Secondary|Overall Survival at 1 Year|One year survival (alive at 1 year from randomization) rate of each treatment group.|1 Year|||Percentage of patients|||Number
110841|NCT00726739|Secondary|Overall Survival at 2 Years|Two year survival (alive at 2 years from randomization) rate of each treatment group.|2 Years|||percentage of patients|||Number
112400|NCT00712335|Secondary|Sputum GM-CSF Levels|Week 24 sputum GM-CSF levels in active treatment groups were measured.|24 weeks|We will use ITT and PP for analysis||pg/ml||Standard Deviation|Mean
110842|NCT00726739|Secondary|Clinical Response of Lesion(s)|Beginning at 2 months Through End of Treatment: To determine clinical response of each treatment group - Best Clinical response will be determined using Solid Tumor Response Criteria (RECIST). Complete Response (CR) = complete disappearance of all target lesions. Partial Response (PR) = At least a 30% decrease in sum of longest diameters of target lesions. Progressive Disease (PD) = At least a 20% increase in sum of longest diameters of target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR or PD.|Month 2 through Month 12|All patients who received at least one dose of study treatment are included. One patient who was originally screened did not receive treatment due to brain metastasis.||participants|||Number
110843|NCT00726739|Primary|Median Time of Progression-free Survival|Progression free survival (PFS) was measured in months from date of randomization to date of disease progression, or date of death. For patients who died without tumor progression, PFS assumes their deaths are randomly related to tumor progression. Therefore, PFS includes deaths if they came first.|From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.|All patients who received at least one dose of study treatment are included. One patient who was originally screened and randomized did not receive treatment due to brain metastasis. This patient was included in PFS analysis based on the intent-to-treat principle, but was excluded from the evaluation of adverse events.||Months||Full Range|Median
110844|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including Potential Antioxidant (PAO)|Analyte levels were taken at 0 (Baseline) and 24 weeks|||µmol/L||Standard Deviation|Mean
110845|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including hs-CRP|Analyte levels were taken at 0 (Baseline) and 24 weeks|||mg/L||Standard Deviation|Mean
110846|NCT00726713|Secondary|Change From Baseline in Total Homocysteine at Week 16 and 24|To determine if Metanx® (compared to placebo) affects change in subjects total homocysteine levels|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks|||µmol/L||Standard Deviation|Mean
110847|NCT00726713|Secondary|(Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24|The Hospital Anxiety and Depression Scale (HADS) consists of a 14-item questionnaire that provides a measurement of depression. Each item is rated on a 4-point scale, giving a maximum scores of 21 for the most severe depression. Depression was evaluated using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, and 24-week evaluation visits|HADS Scores scores were taken at 0 (Baseline) and 24 weeks|||units on a scale (0-21)||Standard Deviation|Mean
110848|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory marker levels, including IL-6 and TNF-α|Analyte levels were taken at 0 (Baseline) and 24 weeks|||pg/mL||Standard Deviation|Mean
110849|NCT00726713|Secondary|Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s lower extremity pain level using a 10-point Visual Analog Scale at Baseline and 24-week evaluation visits.~The Visual Analog Scale (VAS) measures a patients sensation of pain. A 10-cm visual analog scale is used. A measurement on the 10 cm analog scale is used to quantify the level of pain indicated with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable."|VAS scores were taken at 0 (Baseline) and 24 weeks|||units on a scale (0-10)||Standard Deviation|Mean
110850|NCT00726713|Secondary|Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s “quality of life” as determined by the SF-36 questionnaire~The Short Form- 36 Mental Component Summary (SF-36 MCS) and SF-36 Physical Component Summary (SF-36 PCS) both measure health related quality of life, the MCS quantifying mental health and the PCS quantifying physical function. They are both scored on 100 point scales with 0 representing the worst possible outcome and 100 representing the most optimal possible scoring"|SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks|||units on a scale (0-100)||Standard Deviation|Mean
110851|NCT00726713|Secondary|Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24|To determine if Metanx® (compared to placebo) affects a change in subject's total folate and total methyl malonic acid (MMA) at week 16 and 24|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks|||nmol/L||Standard Deviation|Mean
110852|NCT00726713|Secondary|Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24|"This outcome was taken to determine if Metanx® (compared to placebo) has an effect on clinical examination as determined by the Neuropathy Disability Score (NDS)~The Neuropathy Disability Score (NDS) evaluates the severity of individual symptoms of neuropathy. A simple visual numeric distress scale is used that ranges from 0 to 10. The most favorable score is 0, which indicates an absence of symptoms. The most severe symptoms possible would be recorded as a score of 10."|NDS scores were taken at 0 (Baseline), 16, and 24 weeks|||units on a scale (0-10)||Standard Deviation|Mean
110853|NCT00726713|Secondary|Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)|"This measure was taken to determine if Metanx® (compared to placebo) changes neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)~The Neuropathy Total Symptom Score-6 Scale (NTSS-6) is a validated scale that evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). This scale was a modified 6 item scale that consists of yes or no questions. Scores range between 0 and 21.96, a higher score indicates greater severity of symptoms. After adjusting for baseline measurements scores are reflected as negative numbers. Negative numbers indicate improvement in symptoms. ie. a change from baseline after 24 weeks of -2 would be a greater improvement than a change in baseline of -1 after 24 weeks."|NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks|||units on a scale (0-6)||Standard Deviation|Mean
110854|NCT00726713|Primary|Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks|Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.|VPT was measured a 0 (baseline), and 24 weeks|||volts||Standard Deviation|Mean
110965|NCT00725621|Secondary|Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy||24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.||Years||Standard Deviation|Mean
110855|NCT00726661|Secondary|Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy|All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
110856|NCT00726661|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
110857|NCT00726661|Secondary|Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation|Participants were assessed quarterly for progressive events and treatment status.|Approximately 4.5 years|All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point.||participants|||Number
110858|NCT00726661|Secondary|Number of Participants With Tumor Response|The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||participants|||Number
110859|NCT00726661|Secondary|Overall Survival|Overall survival was defined as the time from enrolment to death of any cause.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
110860|NCT00726661|Primary|Progression Free Survival|Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.||months||95% Confidence Interval|Median
110861|NCT00726557|Primary|Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week|Tolerability of the treatment was measured by number of participants with complete treatment.|Assessed at the end of treatment|All enrolled participants||participants|||Number
110862|NCT00726557|Primary|Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions|Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).|End of Follow-up (Week 48 or Week 72, depending on genotype)|Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)||Participants|||Number
110863|NCT00726453|Secondary|Stent Thrombosis (ST)|Stent Thrombosis (ST) (as determined by historic and ARC definitions).|12 months|||percentage of participants|||Number
110864|NCT00726453|Secondary|Target Vessel MI|Target Vessel MI (as determined by extended historical and ARC definitions).|12 months|||percentage of eligible participants|||Number
110865|NCT00726453|Secondary|Death||12 months|||percentage of participants|||Number
110866|NCT00726453|Secondary|Major Adverse Cardiac Event (MACE)|Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).|12 months|||percentage of participants|||Number
110867|NCT00726453|Secondary|Target Vessel Failure (TVF)|Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).|12 months|||percentage of participants|||Number
110868|NCT00726453|Primary|Target Lesion Failure (TLF)|Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.|12 Months|||percentage of participants|||Number
110869|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.||ng-hr/mL||Standard Deviation|Mean
110908|NCT00724945|Primary|Near Visual Acuity|This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.|after 1 week wear|||logMAR units||Standard Error|Least Squares Mean
110870|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.||ng-hr/mL||Standard Deviation|Mean
110871|NCT00726414|Primary|Maximum Plasma Concentration (Cmax) for Quinine Sulfate|The maximum or peak concentration that Quinine Sulfate reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.||ng/mL||Standard Deviation|Mean
110872|NCT00726375|Secondary|The Number of Patients in Complete Remission (CR) at Four Weeks.|"Estimate the proportion of patients in complete remission (CR) at four weeks who remain alive and never require additional therapy four weeks after the last dose of etanercept.~Complete remission is defined as the resolution of all manifestations of GVHD (Graft Versus Host Disease) within the first four weeks of treatment. All organs must have a Grade 0."|28 days|||patients|||Number
110873|NCT00726375|Primary|The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment|We hypothesized that treatment of grade 1 acute GVHD (Graft Versus Host Disease) with etanercept would reduce the proportion of patients who progressed to grade 2 to 4 acute GVHD within 4 weeks of diagnosis from 58%, historically observed at our institution, to 38%.|28 days|||percentage of patients|||Number
110874|NCT00726232|Secondary|Change From Baseline to Week 4 in Health-related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 4 (Cycle 2, Day 1)|Intent to treat population.||units on a scale||Standard Deviation|Mean
110875|NCT00726232|Secondary|Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness."|Baseline and Week 4 (Cycle 2, Day 1)|Essential Thrombocythemia intent to treat population who had symptom scores > 0 at baseline and for whom data was available.||participants||Standard Deviation|Mean
110876|NCT00726232|Secondary|Change From Baseline to Week 4 in Polycythemia Vera Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats."|Baseline and Week 4 (Cycle 2, Day 1)|Polycythemia Vera intent to treat population who had symptom scores > 0 at baseline for whom data was available.||scores on a scale||Standard Deviation|Mean
110877|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 36 weeks (Cycle 10, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
110878|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 24 weeks (Cycle 7, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
110879|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 4 weeks (Cycle 2, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
110880|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 36 (Cycle 10, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
110881|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 24 (Cycle 7, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.||percentage of participants|||Number
110905|NCT00724958|Primary|Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||Days||Full Range|Median
110984|NCT00725452|Secondary|Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.||Days||Standard Deviation|Mean
110882|NCT00726232|Primary|Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~Complete Clinical Response:~Platelet count < 400 x 10^9/L~White blood cell count < 10 x 10^9/L with normal differential and Hematocrit ≤ upper limit of normal~Absence of sustained (> 2 weeks) anemia or leucopenia based on institutional normal ranges~Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias)~Absence of palpable splenomegaly~Partial Clinical Response:~Platelet count < 400 x 10^9/L~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.|Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1.||percentage of participants|||Number
110883|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 12 (Cycle 4, Day 1)|Polycythemia Vera intent to treat population for whom data was available.||percentage of participants|||Number
110884|NCT00726232|Primary|Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~CR:~Hematocrit < 45% in men and < 42% in women~No phlebotomy for 1 month~No palpable splenomegaly~White blood cells < 10 x 10^9/L with normal differential and platelets < 400 x 10^9/L~No sustained leucopenia or thrombocytopenia (>2 weeks)~No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss)~PR:~Hematocrit < 45% in men and < 42% in women~50% reduction in phlebotomy requirements from 6 months before treatment started~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3|Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug.||percentage of participants|||Number
110885|NCT00726180|Primary|Standard Immunohistochemistry and Allred Scores Were to be Used to Measure the Estrogen Receptor (ER) Response Rate in Patients With ER-negative/Low, and Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-positive Breast Cancer.||90 days|Only 1 patient was enrolled to this study, so no data was obtained.|||||
110886|NCT00726063|Secondary|Prosthesis Survival and Procedural Success||3 years||||||
110887|NCT00726063|Primary|Integration Success of the Implant||1 year|Number of implants surviving (lack of mobility) at the end of the study (time of analysis)||implants|Participants||Number
110888|NCT00726037|Secondary|Optimal Time for Future Dendritic Cell Vaccine Administration|The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration|33 Days|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption|||||
110889|NCT00726037|Primary|T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer|The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.|days 8, 12 ,19,26 and 33 post administration|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption|||||
110890|NCT00725985|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Number of participants with AEs includes number of participants with both serious adverse events (SAEs) and non-SAEs.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo) and had at least one safety assessment during the ITP.||Participants|||Number
110891|NCT00725985|Secondary|Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, new or enlarging T2 lesions, and new or persisting T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).||Lesions||Standard Deviation|Mean
110892|NCT00725985|Secondary|Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS|The McDonald criteria use dissemination in time and space established by magnetic resonance imaging (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium enhanced (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions. Kaplan-Meier estimates were provided for the cum. % of participants with McDonald MS over time.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).||Cum. % of participants with McDonald MS|||Number
110906|NCT00724958|Primary|Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||Days||Standard Deviation|Mean
110907|NCT00724945|Primary|Subject Vision|"Subjects responded to How would you rate the overall quality of vision with these study contact lenses using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent."|after 1 week wear|||Scores on a scale||Standard Error|Least Squares Mean
112181|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 1|||days||Standard Deviation|Mean
110893|NCT00725985|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS|Clinically definite multiple sclerosis (CDMS) according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (>=) 1 point if baseline EDSS was between >= 1.0 and less than or equal to (=<) 4.5; or >= 1.5 points if baseline EDSS was 0, or >= 0.5 if baseline EDSS >= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method.|Baseline up to Week 96|The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).||Cum. % of participants with CDMS|||Number
110894|NCT00725920|Primary|Clinician Administered Posttraumatic Stress Disorder Scale|"The Clinician-Administered PTSD Scale (CAPS) [33] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above.~CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28).~CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity."|12 week|||Total CAPS score||Standard Deviation|Mean
110895|NCT00725842|Secondary|Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.|72 weeks post EOT|77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT.||participants|||Number
110896|NCT00725842|Secondary|Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response|Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.|Baseline and 24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.|||||
110897|NCT00725842|Secondary|Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment|Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.|24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.|||||
110898|NCT00725842|Primary|Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.|24 weeks post end of treatment (EOT)|Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT.||participants|||Number
110899|NCT00724984|Primary|Phase II: Overall Response Rate (CR+PR)||From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles|||Percentage of Participants||95% Confidence Interval|Number
110900|NCT00724984|Primary|Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response|Number of patients experienced DLT in each cohort|From the Date of PCI-24781 first administration to Cycle 2 Day 1|||participants|||Number
110901|NCT00724958|Primary|Total Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy.||mg/kg||Standard Deviation|Mean
110902|NCT00724958|Primary|Median Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||mg/kg||Full Range|Median
110903|NCT00724958|Primary|Average Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants||mg/kg||Standard Deviation|Mean
110904|NCT00724958|Secondary|Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.|HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease).|5 years|207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)||Score on a scale||Standard Deviation|Mean
110909|NCT00724945|Primary|Distance Visual Acuity|This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal|after 1 week of wear|Analysis includes participants who completed the study per protocol.||logMAR units||Standard Error|Least Squares Mean
110910|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.|From signing of informed consent to end of trial (7 days after surgery)|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
110911|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs|"An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.~Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration."|From signing of informed consent to end of trial (7 days after surgery)|The All-Subjects-Treated (AST) Population consisted of all randomized participants who received IMP.||participants|||Number
110912|NCT00724932|Other Pre-specified|Time From PACU Admit to Actual PACU Discharge|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From PACU admit to actual PACU discharge (up to ~4.3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110913|NCT00724932|Other Pre-specified|Time From PACU Admit to PACU Discharge Ready|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From PACU admit to PACU discharge ready (up to ~25 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110914|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to Actual PACU Discharge|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110915|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to PACU Discharge Ready|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110916|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual PACU Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110917|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110918|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Actual Operating Room Discharge|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From tracheal extubation to actual OR discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110919|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Operating Room Discharge Ready|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From tracheal extubation to Operating Room discharge ready (up to ~1 minute)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110920|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Actual Operating Room Discharge|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110921|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Operating Room Discharge Ready|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110922|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Tracheal Extubation|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated.|From start of IMP administration to tracheal extubation (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110923|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90|The time of IMP administration was defined as the actual time at which IMP administration was started.|From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Data not collected. In Protocol Amendment 2, this outcome measure was removed.|||||
110924|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual Operating Room Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110925|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Actual Operating Room Discharge|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room admission to actual Operating Room discharge (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110926|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Operating Room Discharge Ready|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.|From Operating Room admission to Operating Room discharge ready (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||minutes||Standard Deviation|Mean
110927|NCT00724932|Other Pre-specified|Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study|Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.|Up to 30 days after IMP administration|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
110928|NCT00724932|Other Pre-specified|Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites|The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.|Up to PACU discharge (up to ~4.5 hours)|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
110929|NCT00724932|Other Pre-specified|Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium|Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.|Up to 7 days after IMP administration|The AST Population consisted of all randomized participants who received sugammadex. Participants who received neostigmine were excluded from this analysis.||participants|||Number
110930|NCT00724932|Other Pre-specified|Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)|Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.|Up to 24 hours after IMP administration|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
110950|NCT00725725|Secondary|Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score|The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT.||MADRS score||Standard Deviation|Mean
110931|NCT00724932|Other Pre-specified|Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.|Up to 30 minutes after IMP administration|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.||participants|||Number
110932|NCT00724932|Other Pre-specified|Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events|Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.|From induction of anesthesia to recovery from NMB (up to ~3 hours)|The AST Population consisted of all randomized participants who received IMP.||participants|||Number
110933|NCT00724932|Other Pre-specified|Number of Participants Who Had Physical Examinations|Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).|At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP. As there was no specific physical examination case report form used in this study, data on whether or not a physical examination was conducted were not recorded.|||||
110934|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.||minutes||95% Confidence Interval|Geometric Mean
110935|NCT00724932|Other Pre-specified|Mean Heart Rate|Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.||beats per minute||Standard Deviation|Mean
110936|NCT00724932|Other Pre-specified|Mean Diastolic Blood Pressure|Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.||mm Hg||Standard Deviation|Mean
110937|NCT00724932|Other Pre-specified|Mean Systolic Blood Pressure|Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.||mm Hg||Standard Deviation|Mean
110938|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group|The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.|From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received neostigmine and had at least one efficacy measurement. The participants who received sugammadex were not included in this analysis.||minutes||95% Confidence Interval|Geometric Mean
110939|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group|The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered.|From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)|The ITT Population consisted of all randomized participants who received sugammadex and had at least one efficacy measurement. The participants who received neostigmine were not included in this analysis.||minutes||95% Confidence Interval|Geometric Mean
110951|NCT00725725|Secondary|Change in Anxiety Sensitivity Index (ASI) Score|The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 48 (higher scores indicate greater fear of anxiety sensations).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT.||ASI Score||Standard Deviation|Mean
149621|NCT00391599|Primary|Number of Participants Had Spontaneous Feces|occurrence of spontaneous feces|On postoperative day 1|||participants|||Number
110940|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.|From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times from administration of last dose of rocuronium to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7, 0.8 and 0.9.||minutes||95% Confidence Interval|Geometric Mean
110941|NCT00724932|Other Pre-specified|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times to recovery of the T4/T1 ratio to 0.5 and 0.6.||minutes||95% Confidence Interval|Geometric Mean
110942|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.||minutes||95% Confidence Interval|Geometric Mean
110943|NCT00724932|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)|The Intent-To-Treat (ITT) Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.||minutes||95% Confidence Interval|Geometric Mean
110944|NCT00725751|Secondary|Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy|This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.|Day 1|Participants who received at least one dose of antiviral treatment.||participants|||Number
110945|NCT00725751|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)|All treated participants.||participants|||Number
110946|NCT00725751|Primary|Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin|For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 to 48 weeks|Participants who received at least one dose of PegIFN-2b/ribavirin||participants|||Number
110947|NCT00725725|Secondary|Number of Participants Discontinuing Study Therapy Due to AEs|The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 2 weeks|All treated participants are included in the safety analysis.||Participants|||Number
110948|NCT00725725|Secondary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 59 days|All treated participants are included in the safety analysis.||Participants|||Number
110949|NCT00725725|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|"The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 (very poor) to 5 (very good), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life)."|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT.||Q-LES-Q Score||Standard Deviation|Mean
110963|NCT00725621|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||mg/kg||Full Range|Median
110952|NCT00725725|Secondary|Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score|The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT.||SIGH-A Score||Standard Deviation|Mean
110953|NCT00725725|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score|The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT.||CGI-S Score||Standard Deviation|Mean
110954|NCT00725725|Secondary|SCID-I/P With Psy Screen Score at EOT|The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT.||Participants|||Number
110955|NCT00725725|Secondary|Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening|The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Screening|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening.||Participants|||Number
110956|NCT00725725|Secondary|Change in PDSS Score From Baseline to Follow-Up|The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Follow-Up (Day 59)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up.||PDSS Score||Standard Deviation|Mean
110957|NCT00725725|Secondary|Change in PDSS Score From Baseline to Visit 4|The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Visit 4 (Day 22)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4.||PDSS Score||Standard Deviation|Mean
110958|NCT00725725|Primary|Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)|The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Day 36|The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT.||PDSS Score||Standard Deviation|Mean
110959|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.||Score on a scale||Standard Deviation|Mean
110960|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.||Score on a scale||Standard Deviation|Mean
110961|NCT00725621|Primary|Median Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Full Range|Median
110962|NCT00725621|Primary|Mean Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Standard Deviation|Mean
110964|NCT00725621|Secondary|Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|Some participants had more than one previous treatment with a DMARD.|24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.||Participants|||Number
110966|NCT00725621|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
110967|NCT00725621|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Full Range|Median
110968|NCT00725621|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Standard Deviation|Mean
110969|NCT00725608|Secondary|Dispensing of Suboxone (Buprenorphine Plus Naloxone)|Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)|month 6, month 12|All participants with eligible datasets were included in the final analysis||Participants|||Number
110970|NCT00725608|Secondary|Dosing of Suboxone (Buprenorphine Plus Naloxone)|One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.|day 1, month 6, month 12|All participants with eligible datasets were included in the final analysis||Dose of Suboxone® in mg||Standard Deviation|Mean
110971|NCT00725608|Primary|Retention Rate|The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study|month 6, month 12|All eligible datasets were included in analysis population.||percentage of patients||95% Confidence Interval|Number
110972|NCT00725543|Primary|Median Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Full Range|Median
110973|NCT00725543|Primary|Mean Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.||mg/kg||Standard Deviation|Mean
110974|NCT00725543|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||mg/kg||Full Range|Median
110975|NCT00725543|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
110976|NCT00725543|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Full Range|Median
110977|NCT00725543|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.||Days||Standard Deviation|Mean
110978|NCT00725530|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|7 days|All enrolled participants.||Participants|||Number
110979|NCT00725491|Primary|The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.|The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.|At completion of ovarian stimulation; maximally after 18 days of recFSH administration.|The number of participants for this analysis included only those participants in the intent-to-treat (ITT) group who received hCG and for whom data was available.||international units (IU)||Standard Deviation|Mean
110980|NCT00725452|Secondary|Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab|BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.|Baseline and Infusion 9|Infliximab-naive participants who received Infliximab during the study.||Percent of BSA involved with psoriasis||Standard Deviation|Mean
110981|NCT00725452|Secondary|Median Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.||mg/kg||Full Range|Median
110982|NCT00725452|Secondary|Mean Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
110983|NCT00725452|Secondary|Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.||Days||Full Range|Mean
112401|NCT00712335|Secondary|Sputum IL-8 Levels|Week 24 sputum IL-8 levels in active treatment groups|24 weeks|We will ITT and PP protocols for analysis||pg/ml||Standard Deviation|Mean
110985|NCT00725452|Primary|Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab|"The types of therapies were assessed according to the following criteria:~Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days).~Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks).~Episodic Therapy: given out of time frame (> 12 weeks)."|Maximum 2 years|Infliximab-naive participants who received Infliximab during the study.||Therapies|||Number
110986|NCT00725296|Primary|Median Dose of All Infusions Per Participant|The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.||mg/kg||Full Range|Median
110987|NCT00725296|Primary|Average Overall Dose of All Infusions Per Participant|The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.||mg/kg||Standard Deviation|Mean
110988|NCT00725296|Primary|Median Dose During Induction Therapy and Subsequent Maintenance Therapy|The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||mg/kg||Full Range|Median
110989|NCT00725296|Primary|Average Dose During Induction Therapy and Subsequent Maintenance Therapy|The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||mg/kg||Standard Deviation|Mean
110990|NCT00725296|Primary|Median Time Interval Between Infusions During Maintenance Therapy|The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||days||Full Range|Median
110991|NCT00725296|Primary|Mean Time Interval Between Infusions During Maintenance Therapy|The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."||days||Standard Deviation|Mean
110992|NCT00725205|Secondary|Number Of Participants Self-Administering Pegylated Interferon Alfa-2b|Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.|Up to 48 Weeks|All Participants enrolled.||Participants|||Number
110993|NCT00725205|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.|24 Weeks following completion of 24 or 48 weeks of therapy|Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.||Participants|||Number
110994|NCT00725205|Primary|Number of Participants Who Are Triple-80 Compliant|Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.|24 or 48 Weeks|"All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being “treatment~failure”. Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12."||Participants|||Number
110995|NCT00725153|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|10 hours|All enrolled participants.||Participants|||Number
110996|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)|Participant productivity was described as the number of days a participant missed work due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
110997|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)|Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
110998|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)|Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
110999|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)|Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
111000|NCT00725101|Secondary|Number of Days of Partial Care for Fibromyalgia (FM) Participants|Partial (day or night) care included day care, day nursing home, and partial hospitalization.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.||days||Standard Deviation|Mean
111001|NCT00725101|Secondary|Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing ER visit values.||ER visits||Standard Deviation|Mean
111002|NCT00725101|Secondary|Number of Outpatient Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing outpatient visit values.||outpatient visits||Standard Deviation|Mean
111003|NCT00725101|Secondary|Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months|The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
111004|NCT00725101|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months|FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
111005|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months|BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-S scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
111006|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months|Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-I scores at Baseline and 12 months.||units on a scale||Standard Deviation|Mean
111007|NCT00725101|Secondary|Hazard Ratios for Factors Associated With Discontinued Opioid Use|Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.|Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.||hazard ratio|||Number
111008|NCT00725101|Secondary|Percentage of Participants Who Discontinued Opioids||Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.||percentage of participants|||Number
111009|NCT00725101|Secondary|Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study|Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.|Baseline through 12 months|The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.||participants|||Number
111020|NCT00725075|Secondary|Change From Baseline in Verbal Memory Score at Week 12|Verbal memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 words within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
132035|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 12 Weeks||over 12 weeks|Number of participants wtih a normal baseline and at least one post-baseline measurement.||participants|||Number
111010|NCT00725101|Primary|Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use|Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.||odds ratio||95% Confidence Interval|Number
111011|NCT00725101|Primary|Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication|Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.||odds ratio||95% Confidence Interval|Number
111012|NCT00725101|Primary|Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months||Baseline through 12 months|The analysis population included enrolled participants who took part in all follow-up interviews.||medications||Standard Deviation|Mean
111013|NCT00725075|Secondary|Change From Baseline in Extrapyramidal Symptoms Rating Scale Score at Week 12|The abbreviated Extrapyramidal Symptoms Rating Scale (ESRS-A) was a sum of the severity rating of a 24-item instrument assessing four types of movement disorders: parkinsonism, dystonia, dyskinesia, and akathisia. Each item was rated on a 7-point scale, from 0=absent to 6=severe. Higher scores indicated more impairment. A negative change from baseline indicated an improvement.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy.||Score on a Scale||Standard Deviation|Mean
111014|NCT00725075|Secondary|Change From Baseline in Composite Memory Score at Week 12|Composite memory was a composite of verbal memory and visual memory and was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111015|NCT00725075|Secondary|Change From Baseline in Executive Functioning Score at Week 12|Executive functioning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Shifting Attention Test. The participant matched geometric shapes either by shape or color. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111016|NCT00725075|Secondary|Change From Baseline in Sustained Attention Score at Week 12|Sustained attention was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was asked to identify a target shape/color when presented with a battery of different geometric shapes/colors. Only Parts 2 to 4 of the 4 Part Continuous Performance Test contributed towards the sustained attention score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111017|NCT00725075|Secondary|Change From Baseline in Working Memory Score at Week 12|Working memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was presented with targets and remembered target presentation sequencing in order to respond to the directions. Only Part 4 of the 4 Part Continuous Performance Test contributed towards the working memory score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111018|NCT00725075|Secondary|Change From Baseline in Speed of Complex Information Processing Score at Week 12|Speed of complex information processing was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Symbol-digit Coding Test. The participant linked numbers to digits. The test consisted of serial presentations of screens, each containing a bank of 8 symbols above and 8 empty boxes below. The participant typed the number that corresponded to the symbol highlighted. The raw score was the processing time in milliseconds. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111019|NCT00725075|Secondary|Change From Baseline in Visual Memory Score at Week 12|Visual memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 geometric figures within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Sore on a Scale||Standard Deviation|Mean
111036|NCT00724893|Secondary|Number of Participants Achieving RVR by Gender (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
132882|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
111021|NCT00725075|Secondary|Change From Baseline in Non-Verbal Reasoning Score at Week 12|Non-verbal reasoning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant solved 15 visual analogies composed of geometric 2x2, 3x3, or 4x4 puzzles by choosing the most appropriate geometric figure that solved the matrix. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111022|NCT00725075|Secondary|Change From Baseline in Perception of Emotions Score at Week 12|Perception of emotion was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant identified different emotional states (happy, sad, angry, and calm [neutral]) presented in pictures of faces by choosing the appropriate word for the emotion. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111023|NCT00725075|Secondary|Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) at Week 12|CDSS was a 9-item clinician-rated instrument used to evaluate depression in participants who have schizophrenia. For each item, symptom severity was rated on a 4-point scale, from 0=absent to 3=severe, with a total scoring range of 0 to 27. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111024|NCT00725075|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Schizophrenia at Week 12|PANSS was a 30-item clinician-rated instrument used for assessing the positive, negative, and general psychopathology symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme, with a total scoring range of 30 to 210. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111025|NCT00725075|Primary|Change From Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS 1-22 Composite Score) at Week 12|SANS was a 25-item clinician-rated instrument for assessing the negative symptoms of schizophrenia. SANS 1-22 Composite Score consisted of the SANS 25 scale minus the last 3 questions (attention items). The remaining non-attention items (affective flattening, alogia, avolition-apathy, and anhedonia-asociality) comprised the SANS 1-22 Composite Score. For each item, symptom severity was rated on a 6-point scale, from 0=absent to 5=severe. The SANS 1-22 Composite Score had a total scoring range of 0 to 110. Higher scores indicated more impairment. The SANS 1-22 Composite Score was reported using data from the adjusted site rater. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.||Score on a Scale||Standard Deviation|Mean
111026|NCT00725049|Secondary|Cost Analysis||3 years||||||
111027|NCT00725049|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.|3 years|Number of participants used in analysis selected as per protocol||participants|Participants||Number
111028|NCT00725010|Primary|Number of Participants Who Discontinued Due to Toxicity||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase|||Participants|||Number
111029|NCT00725010|Primary|Safety: Number of Adverse Events in the Indicated Categories||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase|||Adverse Events|||Number
111030|NCT00724893|Secondary|Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)|Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered “always” or “most of the time” to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants who completed the MAQ questionnaire during the study and achieved SVR||percentage of participants|||Number
111031|NCT00724893|Secondary|Number of Participants Achieving SVR by HIV Status (Stage 2)|"SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|This analysis was not done.|||||
111032|NCT00724893|Secondary|Number of Participants Achieving EVR by HIV Status (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|This analysis was not done.|||||
111033|NCT00724893|Secondary|Number of Participants Achieving RVR by HIV Status (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|This analysis was not done.|||||
111034|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111035|NCT00724893|Secondary|Number of Participants Achieving EVR by Gender (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
132883|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
111037|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111038|NCT00724893|Secondary|Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111039|NCT00724893|Secondary|Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
111040|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111041|NCT00724893|Secondary|Number of Participants Achieving EVR by Weight (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111042|NCT00724893|Secondary|Number of Participants Achieving RVR by Weight (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
111043|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111044|NCT00724893|Secondary|Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111045|NCT00724893|Secondary|Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
111046|NCT00724893|Secondary|Number of Participants Achieving EVR Who Achieved SVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication and achieved EVR||participants|||Number
111047|NCT00724893|Secondary|Number of Participants Achieving RVR Who Achieved SVR (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 4|Participants who achieved RVR||participants|||Number
111048|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111049|NCT00724893|Secondary|Number of Participants Achieving EVR by Race (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
113831|NCT00703391|Primary|Creatinine|Creatinine level greater than the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
111050|NCT00724893|Secondary|Number of Participants Achieving RVR by Race (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
111051|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111052|NCT00724893|Secondary|Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR||participants|||Number
111053|NCT00724893|Secondary|Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5||Participants|||Number
111054|NCT00724893|Secondary|Relapse Rate by HCV Genotype (Stage 1)|The relapse rate was calculated with these parameters: EOT “yes”, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|"All participants who took at least one dose of study medication (ITT population) and had EOT yes and valid EVR evaluation ; no participants had Genotype 5"||Percentage of Participants|||Number
111055|NCT00724893|Secondary|Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Week 12|The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5||Participants|||Number
111056|NCT00724893|Secondary|Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||particpants|||Number
111057|NCT00724893|Secondary|Number of Participants With End of Treatment (EOT) Response (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
111058|NCT00724893|Secondary|Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111059|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111060|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111061|NCT00724893|Secondary|Number of Participants Achieving SVR by EVR Type (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.||participants|||Number
111062|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|From Week 10 to Week 14|The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.||participants|||Number
111063|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
111064|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
111065|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5||participants|||Number
111066|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111067|NCT00724893|Secondary|Number of Participants Achieving SVR by Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111068|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111069|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111070|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)||Participants|||Number
111071|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population).||Participants|||Number
111072|NCT00724893|Secondary|The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data||participants|||Number
113832|NCT00703391|Primary|Total Bilirubin|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||micromol/L||Standard Deviation|Mean
111073|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data||Participants|||Number
111074|NCT00724893|Secondary|Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12||Participants|||Number
111075|NCT00724893|Secondary|Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12||Participants|||Number
111076|NCT00724893|Secondary|Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12||Participants|||Number
111077|NCT00724893|Secondary|Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111078|NCT00724893|Primary|Number of Participants Achieving SVR (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111079|NCT00724893|Primary|Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)|This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT population)||Participants|||Number
111080|NCT00724893|Primary|Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)|This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)||Participants|||Number
111081|NCT00724893|Primary|Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)|This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)||participants|||Number
111082|NCT00724867|Secondary|Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Percentage of Participants|||Number
111083|NCT00724867|Secondary|Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Score on a scale||Standard Deviation|Mean
111091|NCT00724867|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligrams per decilitre (mg/dL) and C4 <16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percent Change||Full Range|Median
111084|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints|The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Score on a scale||Standard Deviation|Mean
111085|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point|The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Score on a scale||Standard Deviation|Mean
111086|NCT00724867|Secondary|Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points|Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change >0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population||Percentage of Participants|||Number
111087|NCT00724867|Secondary|Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage change||Full Range|Median
111088|NCT00724867|Secondary|Observed B-cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Cell count||Full Range|Median
111089|NCT00724867|Secondary|Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with >= 50% reduction in proteinuria among participants with Baseline proteinuria >0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage of Participants|||Number
111090|NCT00724867|Secondary|Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.|Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage of Participants|||Number
111092|NCT00724867|Secondary|Observed Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligram per deciliter (mg/dL) and C4 <16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Milligrams per deciliter||Full Range|Median
111120|NCT00724815|Secondary|Nausea Free at Two Hours|Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
111093|NCT00724867|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.|Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Percentage change||Full Range|Median
111094|NCT00724867|Secondary|Observed Anti-double Stranded DNA Levels at Indicated Time Points.|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA >=30 International Units/milliliter [IU/mL]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||International units per milliliter||Full Range|Median
111095|NCT00724867|Secondary|Percentage of Participants Achieving SRI Response at Indicated Time Points|The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MIIT Population||Percentage of Participants|||Number
111096|NCT00724867|Secondary|Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.|Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (<0.5 nanograms per milliliter [ng/mL]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 392|MITT Population||Participants|||Number
111097|NCT00724867|Primary|Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population. Only those subjects with abnormal (>124 umol/L) creatinine at baseline by year interval.||Percentage of Participants|||Number
111098|NCT00724867|Primary|Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Percentage of Participants|||Number
111099|NCT00724867|Primary|Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Millimeters of mercury||Standard Deviation|Mean
111100|NCT00724867|Primary|Number of Participants With the Indicated Immunogenic Response|Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Participants|||Number
111119|NCT00724854|Primary|Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment|Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.|Assessed at Treatment Week 4|||Participants|||Number
149622|NCT00391599|Primary|Number of Participants With Gas Passage|gas passage: present|On postoperative day 1|||participants|||Number
111101|NCT00724867|Primary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population||Units per liter||Standard Deviation|Mean
111102|NCT00724867|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Ratio||Standard Deviation|Mean
111103|NCT00724867|Primary|Change From Baseline in Creatinine Clearance at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Milliliters per second||Standard Deviation|Mean
111104|NCT00724867|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Micromoles per liter||Standard Deviation|Mean
111105|NCT00724867|Primary|Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Millimoles per liter||Standard Deviation|Mean
111106|NCT00724867|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Grams per liter||Standard Deviation|Mean
111107|NCT00724867|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Grams per liter||Standard Deviation|Mean
111108|NCT00724867|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Percentage||Standard Deviation|Mean
132884|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
111109|NCT00724867|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Trillions cells per liter||Standard Deviation|Mean
111110|NCT00724867|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Billion cells per liter||Standard Deviation|Mean
111111|NCT00724867|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population||Seconds||Standard Deviation|Mean
111112|NCT00724867|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / participants Years. participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to Week 440|MITT Population||Adverse events/100 participant-years|||Number
111113|NCT00724867|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / Participant Years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up Week 440|MITT Population||Adverse events/100 participant-years|||Number
111114|NCT00724867|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.|Up to Week 440|Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.||Participants|||Number
111115|NCT00724854|Secondary|Assessment of Baseline Characteristics in Participants With SVR|Baseline characteristics assessed were age, gender, and genotype.|24 Weeks post-treatment|Participants with SVR||Participants|||Number
111116|NCT00724854|Secondary|Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR|Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.|Treatment Week 48 and Treatment Week 72|Participants who achieved RVR at Treatment Week 4.||Participants|||Number
111117|NCT00724854|Secondary|Number of Participants With RVR Who Also Achieved SVR|RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.|Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)|Participants who achieved RVR at Treatment Week 4.||Participants|||Number
111118|NCT00724854|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.|Assessed at 24 weeks post-treatment|||Participants|||Number
149623|NCT00391599|Primary|Number of Participants With Bowel Sounds|bowel sounds: present|On postoperative day 1|||participants|||Number
111121|NCT00724815|Secondary|Phonophobia Free at Two Hours|Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
111122|NCT00724815|Secondary|Photophobia Free at Two Hours|Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
111123|NCT00724815|Primary|Pain Free at Two Hours|Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.||participants|||Number
111124|NCT00724750|Secondary|Average Cost of Supplies and Rental|Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).|Participants were followed for the duration of inpatient stay, an average of 5 days.|||dollars||Standard Deviation|Mean
111125|NCT00724750|Secondary|Pain Score With Dressing Changes|Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.|Participants were followed for the duration of inpatient stay, an average of 5 days.|||units on a scale||95% Confidence Interval|Mean
111126|NCT00724750|Secondary|Average Time Spent on Dressing Changes|Time was measured from the start of the dressing change until the initiation of suction.|Participants were followed for the duration of inpatient stay, an average of 5 days.|||minutes||Standard Deviation|Mean
111127|NCT00724750|Secondary|Failure to Maintain Dressing Because of Fluid or Suction Leaks||Participants were followed for the duration of inpatient stay, an average of 5 days.|||participants|||Number
111128|NCT00724750|Primary|Percent Change Per Day in Wound Volume|Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days|||% change per day||95% Confidence Interval|Mean
111129|NCT00724750|Primary|Percent Change Per Day in Wound Surface Area|Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days|||% change per day||95% Confidence Interval|Mean
111130|NCT00724711|Secondary|Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Participants Enrolled after Amendment 3~Missing = Excluded"||pg/mL||Standard Deviation|Mean
111131|NCT00724711|Secondary|Change From Baseline Fibrinogen at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"||mg/dL||Standard Deviation|Mean
111132|NCT00724711|Secondary|Change From Baseline C-Reactive Protein at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"||mg/dL||Standard Deviation|Mean
111133|NCT00724711|Secondary|Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||Ratio||Standard Deviation|Mean
111134|NCT00724711|Secondary|Change From Baseline Fasting Lipid Parameters at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||mg/dL||Standard Deviation|Mean
111135|NCT00724711|Secondary|Change From Baseline Fasting Glucose at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||mg/dL||Standard Deviation|Mean
111136|NCT00724711|Secondary|Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set||mL/min/1.73m^2||Standard Deviation|Mean
111137|NCT00724711|Secondary|Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set: The treated analysis set included all randomized participants who received at least one dose of study drug. Participants who were randomized to continue ABC/3TC+PI/r during the study were included in the treated analysis set if they took at least one dose of their study drug after the baseline visit.||mL/min||Standard Deviation|Mean
111138|NCT00724711|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"ITT Analysis Set~Missing = Excluded: Participants with missing values were excluded from this analysis"||cells/microliter||Standard Deviation|Mean
111139|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~TLOVR: No virologic rebound on or before Week 48; no discontinuation before Week 48; no new ARV by study completion~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 50 copies/mL~Virologic Success: Last available HIV-1 RNA < 50 copies/mL in Week 48 window on randomized treatment"||percentage of participants|||Number
111140|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 200 copies/mL~Virologic Success: Last available HIV-1 RNA < 200 copies/mL in the Week 48 window while on randomized treatment"||percentage of participants|||Number
111141|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set||percentage of participants|||Number
111142|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set||percentage of participants|||Number
111143|NCT00724711|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm|The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|Intent-to-treat (ITT) Analysis Set: Participants who were treated with at least one dose of study drug with no documented resistance to study drug prior to screening.||percentage of participants|||Number
111144|NCT00724698|Primary|Adverse Events|Number of adverse events reported|Final Visit (Day 15)|||adverse events reported|||Number
111145|NCT00724594|Primary|PT||prior to delivery and in newborn DOL1||||||
111146|NCT00724594|Primary|Cerebral Blood Flow||prior to delivery and in newborn after delivery, during 2 days of NAC infusion||||||
111147|NCT00724594|Primary|Maternal and Infant Mean Blood Pressure Change||Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing|The infant and maternal populations analyzed for this portion are incomplete, as not all individuals had paired before/after blood pressure measurements at this time point.||mmHg||Standard Deviation|Mean
111148|NCT00724594|Primary|Placental Transfer Ratio|Ratio of NAC concentration in cord to maternal venous blood|At time of delivery|||ratio||Standard Deviation|Mean
111149|NCT00724594|Secondary|Cytokine Levels in Plasma and CSF||During 2 days of NAC infusion||||||
111150|NCT00724594|Primary|NAC Concentrations||Peak: 30 minutes after NAC infusion. Cord: at delivery|||micromol/L||Standard Deviation|Mean
111151|NCT00724594|Primary|NAC Total Body Clearance||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion|||mL/h/kg||Standard Deviation|Mean
111152|NCT00724594|Primary|NAC Volume of Distribution||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion|||L/kg||Standard Deviation|Mean
111153|NCT00724594|Secondary|Magnetic Resonance Spectroscopy of Infants||36 - 40 weeks gestational age||||||
111154|NCT00724594|Primary|NAC Terminal Elimination Half-life||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion|||hours||Standard Deviation|Mean
111155|NCT00724568|Secondary|The Percentage of Patients That Achieved Partial or Complete Response to Treatment.|"Partial Response:~50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.~If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to <200 mg for at least two determinations six weeks apart.~50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks.~No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).~Complete Response:~Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks.~<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks.~No increase in the size or number of lytic bone lesions."|24 weeks (8, 21-day cycles)|74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.||percentage of patients|||Number
111156|NCT00724568|Primary|Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)|"Dose Level 1:~15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 2:~20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 3:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 4:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 30 mg/m2 Doxil daily on day 4"|1 month post treatment|A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.||mg|||Number
111157|NCT00724477|Primary|Number of Participants Reaching the Targeted LDL-C Levels|"A subject was considered to have met targeted LDL-C levels (been controlled) if:~subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L,~subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L,~subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L,~subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L,~subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L."|1 to 3 months after starting treatment|This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol.||Participants|||Number
111158|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule|SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.|24 weeks following completion of 24 or 48 weeks of therapy|No data had been captured in the Case Report Forms, and therefore no relevant analysis had been performed.|||||
111159|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 250 participants.||Participants|||Number
111160|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis.||Participants|||Number
111161|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 6 participants.||Participants|||Number
111162|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 32 participants.||Participants|||Number
111163|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 157 participants.||Participants|||Number
111164|NCT00724464|Primary|Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up|Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.||Participants|||Number
111165|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. 23 participants were relapsers.||Participants|||Number
111166|NCT00724464|Primary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.||Participants|||Number
111167|NCT00724451|Secondary|Number of Participants With Treatment Failure by Reason for Failure|Investigators recorded reasons for treatment failure whether or not treatment was completed.|24 to 48 weeks|132 of the 500 treated participants failed treatment per Investigator assessment.||participants|||Number
111168|NCT00724451|Secondary|Number of Participants Discontinued From Treatment by Reason for Discontinuation|Investigators recorded reasons for treatment discontinuation.|24 weeks after the end of treatment (total of 48 to 72 weeks)|Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.||participants|||Number
111169|NCT00724451|Primary|Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility|Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.|Measured at baseline|431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.||participants|||Number
111170|NCT00724373|Primary|Participants With Treatment Success|Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).|Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.|Number of participants who had treatment success.||Participants|||Number
111171|NCT00724347|Primary|.Speech Discrimination Ability|Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.|Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..|older hearing impaired listeners with hearing aids.||signal to noise ratio in dB SNR||Standard Deviation|Mean
111172|NCT00724308|Secondary|VA Site-level Performance Rates on the VA Tobacco Performance Measures||Quarterly after study implementation||||||
111173|NCT00724308|Secondary|Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)||2 and 6 months after enrollment||||||
111174|NCT00724308|Secondary|Quit Attempt Rate||2 and 6 months after enrollment||||||
111175|NCT00724308|Secondary|30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)||2 months after enrollment||||||
111176|NCT00724308|Primary|Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)||6 months after enrollment|||participants|||Number
111177|NCT00724282|Primary|Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test||at the end of each treatment|Investigator left university without analyzing data and no information is available on unblinding.|||||
111178|NCT00724243|Primary|Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria|Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 14 and Week 54|||Participants|||Number
111179|NCT00724243|Primary|Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|Baseline, Week 14, and Week 54|"Thirty-three participants had a DAS 28 score at the beginning of treatment.~Twenty-eight participants had a DAS 28 score at Week 14.~Twenty-two participants had a DAS 28 score at Week 54."||Units on a Scale||Standard Deviation|Mean
111180|NCT00724152|Secondary|Tinnitus Reaction Questionnaire (TRQ)|This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach’s alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)|Period 1 and Period 2||units on a scale ranging 0-104||Standard Deviation|Mean
111181|NCT00724152|Primary|Tinnitus Handicap Inventory (THI)|Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients’ responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the “no handicap” range. This measure has strong internal consistency reliability (Cronbach’s alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)|Period 1 and Period 2||units on a scale of 0-100||Standard Deviation|Mean
111198|NCT00723957|Secondary|Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors|Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.|Randomization to death or last known alive date, up to 31.34 months|All participants randomized to receive treatment||Months||95% Confidence Interval|Median
111182|NCT00724126|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.||percentage of responders|||Number
111183|NCT00724126|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.||percentage of responders|||Number
111184|NCT00724061|Other Pre-specified|Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells||Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase||||||
111185|NCT00724061|Other Pre-specified|Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment|The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients.|At baseline and after 2 weeks of treatment (for those patients who consented to this portion)||||||
111186|NCT00724061|Secondary|To Evaluate the Duration of Response|To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.|At each study visit||||||
111187|NCT00724061|Secondary|Number of Patients Exhibiting a Complete Response|"Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease.~CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR."|From the date the first patient begins treatement until the last patient achieves complete response (response was assessed every 4 weeks)||||||
111188|NCT00724061|Primary|Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy – Biologic Response Modifier (FACT-BRM)|The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.|From the date that the first patient was registerd until the last patient came off treatment (score assessed at baseline, every 2 weeks during dose escalation, and then monthly during maintenance therapy for each patient)||||||
111189|NCT00724061|Primary|Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b|"Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity."|From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)|||dose limiting toxicities|||Number
111190|NCT00724009|Secondary|Leukemia Free Survival|Time to event analysis used the day of transplant as day 0.|2 years|One patient with refractory AML underwent conditioning but died 1 day before stem cell infusion due to sepsis (grade 5 infection)||days||95% Confidence Interval|Median
111191|NCT00724009|Secondary|Number of Participants Infection Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
111192|NCT00724009|Secondary|Number of Participants With Skin Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
111193|NCT00724009|Secondary|Number of Participants With Cardiac Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
111194|NCT00724009|Secondary|Number of Participants With Hepatic (SGOT) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
111195|NCT00724009|Secondary|Number of Participants With Hepatic (Total Bilirubin) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
111196|NCT00724009|Secondary|Number of Participants With Renal Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12|||participants|||Number
111197|NCT00724009|Primary|Cytoreductive Response|Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%|Day 12|||percentage of participants|||Number
111212|NCT00723892|Primary|Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.||12 months after onset of treatment|Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.||Participants|||Number
111199|NCT00723957|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results|ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN|At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)|All participants who received any investigational product.||Participants|||Number
111200|NCT00723957|Secondary|Number of Participants With Hematology Laboratory Results of Grade 3 or 4|LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: <LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3: <2.0 to 1.0*10^9/L, Grade 4: <1.0*10^9/L; Neutrophils (neutropenia) Grade 1: <LLN to 1.5*10^9/L, Grade 2: <1.5 to 1.0*10^9/L, Grade 3: <1.0 to 0.5*10^9/L, Grade 4: <0.5*10^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0*10^9/L, Grade 2: <75.0 to 50.0*10^9/L, Grade 3: <50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L; Hemoglobin (anemia) Grade 1: <LLN to 10.0 g/dL, Grade 2: <10.0 to 8.0 g/dL, Grade 3: <8.0 to 6.5 g/dL, Grade 4: <6.5 g/dL.|At screening and weekly during 21-day cycle|All participants who received any investigational product.||Participants|||Number
111201|NCT00723957|Secondary|Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21, continuously|All participants who received any investigational product.||Participants|||Number
111202|NCT00723957|Secondary|Time to Response|Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])|Randomization to date of first response (PR or CR)|All randomized participants||Weeks||Full Range|Median
111203|NCT00723957|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)|Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles|||Percentage of participants||95% Confidence Interval|Mean
111204|NCT00723957|Secondary|Progression-free Survival in the Overall Population|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death, assessed to 12.29 months|All randomized participants who received study drug||Months||95% Confidence Interval|Median
111205|NCT00723957|Secondary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death (maximum reached: 12.29 months)|All randomized participants who had βIII-tubulin positive tumors and who received study drug||Months||95% Confidence Interval|Median
111206|NCT00723957|Primary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.|Randomization to disease progression or death (maximum reached: 14.39 months )|All randomized participants with βIII-tubulin positive tumors and who received study drug||Months||95% Confidence Interval|Median
111207|NCT00723944|Secondary|Osseous Integration||4 years||||||
111208|NCT00723944|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.||millimeters|Participants|Standard Error|Mean
111209|NCT00723931|Primary|Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold|Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection.|||Participants|||Number
111210|NCT00723931|Primary|Number of Participants That Reported a Serious Adverse Event|Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection|||Participants|||Number
111211|NCT00723892|Secondary|the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol||12 months after onset of treatment|Participants with no missing results.||Weeks||Standard Deviation|Mean
112182|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Baseline|||days||Standard Deviation|Mean
111213|NCT00723840|Primary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease|"EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score >= 150.~EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.||Score on a scale|||Number
111214|NCT00723840|Primary|Cost of Illness in Participants With Crohn's Disease|"Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score >= 150.~Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.||Euros|||Number
111215|NCT00723827|Primary|Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)|The response ratings were based on the judgment of the investigator.|Complete study duration (up to approximately 6.5 months)|||participants|||Number
111216|NCT00723827|Primary|Number of Temozolomide Drug Interactions|Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||events|||Number
111217|NCT00723827|Primary|Number of Temozolomide Misuse or Abuse Events|"Drug abuse was defined as the use of the study drug for a non-therapeutic effect.~Misuse was defined as use of the study medication in a way that was not prescribed."|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||Events|||Number
111218|NCT00723827|Primary|Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)|An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||participants|||Number
111219|NCT00723827|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.|Complete study duration & 30 days after completion (up to approximately 7.5 months)|||participants|||Number
111220|NCT00722800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|6 months|||points||Standard Deviation|Mean
111221|NCT00722800|Secondary|Change From Baseline in VAS Pain Scale at Month 6.|"For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated no pain and a score of 10 indicated worst pain. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|6 months from Baseline|||units on a scale||Standard Deviation|Mean
111222|NCT00722800|Primary|Mean Improvement in the Sartorius Severity Score at Month 6.|The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|6 months|||units on a scale||Standard Deviation|Mean
111223|NCT00722761|Secondary|Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination|Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100.|24 weeks|Intention to treat analysis. Participants with at least one follow up visit were included in the analysis. Last observation carried forward was used to fill up missing values/||percentage of participants|||Number
111224|NCT00722761|Primary|Percent Change in Truncal Lesion Counts|Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.|0-24 weeks|Intention to treat analysis. Only participants with at least one follow up were included in the analysis. Last observation carried forward was used to fill up missing data.||percentage change of lesions||Standard Deviation|Mean
111225|NCT00722722|Primary|Response to Bortezomib Monotherapy|Response to treatment with Bortezomib (BTZ) alone was defined as a reduction in serum Donor Specific Alloantibody (DSA) levels following treatment. DSA levels were measured prior to treatment and after treatment. A good response occurred if all DSA were reduced. A partial response when a reduction was observed in at least one DSA, but not all DSA. No response occurred when no reduction of any DSA was attained.|6 months|In the 32 dose group, one patient received a kidney transplant with a B-cell flow cytometric crossmatch channel shift of less than 300 after dose 20 and was transplanted with a positive crossmatch donor. This patient was then excluded from further DSA analysis.||participants|||Number
111226|NCT00723801|Secondary|Diastolic Function - Ejection Fraction|Two-dimensional echocardiography was performed using a 3.0 MHz transducer (General Electric VIVID 7). Left ventricular and left atrial dimensions were determined in parasternal long axis views. Left ventricular ejection fraction was calculated using the modified Simpsons calculation in the apical two and four chamber views.|Baseline and 6 months|||Change in % ejection fraction||Standard Deviation|Mean
111227|NCT00723801|Primary|Aortic Biophysical Properties - Pulse Wave Velocity|Aortic stiffness was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, West Ryde, NSW, Sydney, Australia) to measure carotid to femoral artery pulse wave velocity (PWV). With the patient lying supine in a quiet environment, a handheld micromanometer-tipped probe was applied to the skin surface over the carotid and femoral arteries, compressing the vessel wall so that transmural forces within the vessel wall were perpendicular to the arterial surface. The distance from the sternal notch to the sites of carotid and femoral pulse acquisition were measured and inputted into the device to represent the relative distance from the carotid to femoral artery. The calculation of distance divided by time of pulse upstroke relative to the upstroke of the QRS on a 3 lead surface EKG was used by the device to calculate velocity. All recorded measurements met the manufacturer’s quality control standards integrated into the software package.|Baseline and 6 months|||change in meters/second||Standard Deviation|Mean
111228|NCT00723788|Primary|Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up|Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)|during diagnostic procedure|All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures.||participants|||Number
111229|NCT00723749|Secondary|Drug Craving (Subjective Effects of Therapy)|Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)|Baseline and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||Units on a scale||Standard Deviation|Mean
111230|NCT00723749|Secondary|Take Home Prescriptions of SUBOXONE®|"Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.~Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.~A patient can receive only one take home prescription for up to 7 days at the time."|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||participants with take home prescription|||Number
111231|NCT00723749|Primary|Retention Rate After 12 Months of Treatment With Suboxone|The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.|12 months|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||% of participants||95% Confidence Interval|Number
111232|NCT00723749|Secondary|Dosage of SUBOXONE®|Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).||mg daily dosage of Suboxone||Standard Deviation|Mean
111233|NCT00723736|Primary|Proportion of Patients With Adverse Events|An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.|Follow-up visit at 3 - 5 weeks after treatment initiation|||participants|||Number
111234|NCT00723710|Primary|Number of Participants Who Completed Treatment|Treatment completion was defined as those who completed both the induction and maintenance phases.|Up to 1 year|The number of participants who started the induction phase||Participants|||Number
111235|NCT00723697|Primary|Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.|Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|All eligible patients||participants|||Number
111236|NCT00723697|Secondary|Number of Patients Reporting Clinical Consequences of Engaging in Misuse|Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.|first visit, 6 months, and 12 months|Number of patients analyzed for the consequence, at each visit.||participants|||Number
111237|NCT00723697|Primary|Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)|Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|Number of patients with self-questionnaire responses.||participants|||Number
111238|NCT00723645|Secondary|Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)|"Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72.~SVR was defined as negative for HCV RNA at Week 24 of follow-up."|From 24 weeks post-treatment to 72 weeks post-treatment|"The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2).~187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3)."||Percentage of participants||95% Confidence Interval|Number
133284|NCT00528645|Secondary|Time to Disease Progression|Will be estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 2 years||||||
111239|NCT00723645|Primary|Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)|"Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT.~RNA= Ribonucleic Acid"|From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment|The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).||Percentage of participants||95% Confidence Interval|Number
111240|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Prior Treatment Status|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.||Czech Crown||Full Range|Mean
111241|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Ribavirin Dosage|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.||Czech Crown||Full Range|Mean
111242|NCT00723632|Primary|Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.||Czech Crown||Full Range|Mean
111243|NCT00723606|Secondary|Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours|BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
111244|NCT00723606|Secondary|Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
111245|NCT00723606|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
111246|NCT00723606|Secondary|Change From Baseline in BPRS Agitation Subscale Score at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.||scores on a scale||Standard Error|Least Squares Mean
111247|NCT00723606|Secondary|BPRS Agitation Subscale Response at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score.|72 hours|FAS. Missing data were replaced by last observation carried forward (LOCF).||participants|||Number
111248|NCT00723606|Primary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours|BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.|Baseline, 72 hours|Per protocol (PP) population = Full Analysis Set (FAS) subjects (ie, randomized subjects who took at least one dose of study medication) who provided a baseline and 72 hour BPRS total score and did not deviate from the protocol in a significant manner.||scores on a scale||Standard Error|Least Squares Mean
111249|NCT00723580|Secondary|The Personality Inventory for Children: Family Relations Scale|The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
111250|NCT00723580|Secondary|The Personality Inventory for Children: Social Skills Scale|The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
111251|NCT00723580|Secondary|The Personality Inventory for Children: Withdrawal Scale|The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function|May-7-2008 to July -14-2010||||||
111252|NCT00723580|Secondary|The Personality Inventory for Children: Delinquency Scale|The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May 7, 2008-July 14,2010||||||
111253|NCT00723580|Secondary|The Personality Inventory for Children: Somatic-Physiological Scale|The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
111254|NCT00723580|Secondary|The Personality Inventory for Children: Achievement Scale|The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010||||||
111255|NCT00723580|Secondary|The Personality Inventory for Children: Adjustment Scale|This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment and developmentally associated change.|May-7-2008 to July -14-2010||||||
111256|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Hyperactivity Observed||May-7-2008 to July -14-2010||||||
111257|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Distractibility Observed||May-7-2008 to July -14-2010||||||
111258|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Irritability Observed||May-7-2008 to July -14-2010||||||
111259|NCT00723580|Secondary|Systematic Observation Scale Item: Percentage of Impulsivity Observed|The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.|May-7-2008 to July -14-2010||||||
111260|NCT00723580|Primary|Actigraphic Measurement of Treatment Conditions|The child’s impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.|May 12- July 14, 2010|Single subject repeated Actigraphic(at thirty second intervals), observational (every two months) and psychometric (baseline and at 23 months) measurements of a child anticipating pharmacological treatment. Actigraphic measurements (three 21 day periods) over five treatment conditions that included a non-medication baseline and spanned 23 months.||activity|Participants|Standard Deviation|Mean
111261|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111262|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111281|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
111931|NCT00717977|Primary|Daytime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111263|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111264|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111265|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111266|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111267|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111268|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111269|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111270|NCT00723554|Secondary|New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||participants|||Number
111271|NCT00723554|Secondary|Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
111272|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
111273|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
111274|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||percentage of complete doses||Standard Deviation|Mean
111275|NCT00723554|Secondary|Change in Average Number of Daily Doses - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
111276|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
111277|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
111278|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||doses per day||Standard Deviation|Mean
111279|NCT00723554|Secondary|Change in Average Number of Days of Dosing - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
111280|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
111302|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Serious AEs|Number of patients reporting at least one treatment-emergent serious AEs|From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population||participants|||Number
113833|NCT00703391|Primary|Creatine Kinase (CK)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||IU/L||Standard Deviation|Mean
111282|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||days||Standard Deviation|Mean
111283|NCT00723554|Secondary|Change in Average Inhalation Time - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
111284|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
111285|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
111286|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.||minutes||Standard Deviation|Mean
111287|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 3)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
111288|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 2)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
111289|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 3)|Heart rate was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
111290|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 2)|Heart rate was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed||beats per minute||Standard Deviation|Mean
111291|NCT00723554|Primary|Heart Rate - Iloprost PD-6 (Period 1)|Heart rate was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population||beats per minute||Standard Deviation|Mean
111292|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 3)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111293|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 2)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111294|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 3)|Diastolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111295|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 2)|Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111296|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-6 (Period 1)|Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1|||mmHg||Standard Deviation|Mean
111297|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 3)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111298|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 2)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111299|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 3)|Systolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111300|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 2)|Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed||mmHg||Standard Deviation|Mean
111301|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-6 (Period 1)|Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population||mmHg||Standard Deviation|Mean
114571|NCT00697593|Primary|Hematology - Hematocrit|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values||packed cell volume||Standard Deviation|Mean
111303|NCT00723554|Primary|Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE|Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment|From the first dose of investigational product to study discontinuation, an average of approximately 268 days|Safety population||participants|||Number
111304|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Adverse Events (AEs)|Number of patients reporting at least one treatment-emergent AE/Serious AE|From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population||participants|||Number
111305|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.||Percentage of participants|||Number
111306|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.||Percentage of participants|||Number
111307|NCT00723528|Secondary|Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64|Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
111308|NCT00723528|Secondary|Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64|The number of nails with psoriasis involvement was assessed by a dermatologist.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Nails||Standard Deviation|Mean
111309|NCT00723528|Secondary|Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 12, 28, 40,52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
111310|NCT00723528|Secondary|Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64|The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
111311|NCT00723528|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
111322|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters||participants|||Number
154743|NCT00339833|Primary|Change in the Average Serum Insulin Concentration During the Last 40 Min of Clamp||last 40 min of clamp|||l/min||Standard Deviation|Mean
111312|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.||Unit on scale||Standard Deviation|Mean
111313|NCT00723528|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.||Percentage of participants|||Number
111314|NCT00723528|Secondary|Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.||Percentage of treatment response||Standard Deviation|Mean
111315|NCT00723528|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.||Units on a scale||Standard Deviation|Mean
111316|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 12|"The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. N (number of participants analyzed) signifies the participants evaluable for this measure."||Units on scale||Standard Deviation|Mean
111317|NCT00723528|Primary|Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score|Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.||Percentage of participants|||Number
111318|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
111319|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC –(AD) Compared to YFV-17D SC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
111320|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
111321|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC – (AD) Compared to YFV-17D SC – (Non- AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 – 35).|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(Non-AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing||Log10 cell count/10^6 cells||Standard Deviation|Mean
111323|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D TC– (AD) Participants Compared to YFV-17D TC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters||participants|||Number
111324|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted||Log10 (NT50)||Standard Deviation|Mean
111325|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC – (AD) Participants Compared to YFV-17D TC – (Non – AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted||Log10 (NT50)||Standard Deviation|Mean
111326|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC – (AD) Participants Compared to YFV-17D SC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)|All participants who completed the study; and seroconverted||Log10 Neutralization Index (LNI)||Standard Deviation|Mean
111327|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC– (AD) Participants Compared to YFV-17D TC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted||LNI||Standard Deviation|Mean
111328|NCT00723450|Secondary|Change From Randomization in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Randomized Phase.|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111329|NCT00723450|Secondary|Change From Baseline in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Open-Label Phase|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111330|NCT00723450|Secondary|Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111331|NCT00723450|Secondary|Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111332|NCT00723450|Secondary|Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111932|NCT00717977|Primary|Peak Nightime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111333|NCT00723450|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111334|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Randomization in the Randomized Phase|The CGI-BP(I) asks the following question: “Compared to the Randomization assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Participants|||Number
111335|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Baseline in the Open-Label Phase|The CGI-BP(I) asks the following question: “Compared to the Baseline assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.||Participants|||Number
111336|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase|Improvement of bipolar illness was based on the CGI-BP(I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Randomization weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32 and 36|Randomized ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Randomized ITT Population.||Scores on a scale||Standard Deviation|Mean
111337|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase|Improvement of bipolar illness was based on the CGI-BP (I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.||Scores on a scale||Standard Deviation|Mean
111338|NCT00723450|Secondary|Change From Randomization in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111339|NCT00723450|Secondary|Change From Baseline in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111340|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111341|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111355|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|||percentage of participants||95% Confidence Interval|Number
114572|NCT00697541|Primary|Tmax - Time to Maximum Plasma Concentration|time to maximum plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose|||Hours||Full Range|Mean
111342|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population||Scores on a scale||Standard Error|Least Squares Mean
111343|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT population: all participants who entered the Open-Label Phase and received at least one dose of LTG.||Scores on a Scale||Standard Error|Least Squares Mean
111344|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase|The proportion of participants (par.) requiring intervention to treat either the emergence of or a change in bipolar symptoms, that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state at any time within the first 30, 90, and 180 days in the Randomized Phase were analyzed.|From randomization up to Week 36|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.||Participants|||Number
111345|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State|The number of participants requiring intervention to treat either the emergence of or a change in bipolar symptoms that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state were analyzed.|From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36)|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.||Participants|||Number
111346|NCT00723450|Secondary|Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix)|The time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix) was analyzed. TIDep, TIMan, and TIMix were calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36)|Randomized ITT Population||Days||Standard Error|Mean
111347|NCT00723450|Secondary|Time From Randomization to Intervention for a Mood Episode (TIME)|The time from randomization to the intervention for a mood episode (depression, mania/hypomania or mixed mood) was analyzed. TIME was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for a mood episode (up to Week 36)|Randomized ITT Population||Days||Standard Error|Mean
111348|NCT00723450|Secondary|Time From Randomization to Withdrawal From the Study for Any Cause (TTW)|The time from randomization to the withdrawal from study was analyzed. TTW was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until withdrawal from the study for any cause (up to Week 36)|Randomized ITT Population||Days||Standard Error|Mean
111349|NCT00723450|Primary|Time From Randomization to the Occurrence of a Bipolar Event (TOBE)|TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until Week 36|Randomized Intent-to-Treat (ITT) Population: all participants who were randomized to LTG or placebo and received at least one dose of investigational product.||Days||Standard Error|Mean
111350|NCT00723255|Primary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Adverse event data are presented in the Adverse Event section of this report.|Up to 5 years||||||
111351|NCT00723255|Secondary|The Frequency and Severity of Adverse Effects as Assessed by CTCAE v3.0||Up to 5 years||||||
111352|NCT00723255|Secondary|Progression-free Survival at 6 Months by Tumor Grade|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|||percentage of participants||95% Confidence Interval|Number
111353|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|||percentage of participants||95% Confidence Interval|Number
111354|NCT00723255|Secondary|Progression-free Survival at 6 Months by Histologic Type|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|||percentage of participants||95% Confidence Interval|Number
111933|NCT00717977|Primary|Peak Daytime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111356|NCT00723255|Secondary|Progression-free Survival at 6 Months by Performance Status|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|||percentage of participants||95% Confidence Interval|Number
111357|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Performance Status|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|||percentage of participants||95% Confidence Interval|Number
111358|NCT00723255|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, up to 5 years|Eligible and Treated Patients||Months||95% Confidence Interval|Median
111359|NCT00723255|Secondary|Progression-Free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated Patients||Months||95% Confidence Interval|Median
111360|NCT00723255|Primary|Progression-free Survival at 6 Months|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
111361|NCT00723255|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
111362|NCT00723203|Primary|Hematological Response Rate|Morphologic CR: morphologic leukemia-free state with absolute neutrophil count > 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (<1000/uL) and/or thrombocytopenia (<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value > 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.|Up to 6 cycles of treatment, up to 24 weeks.|Three patients of the 16 accrued were not included in the analysis for response per protocol due to patient refusal for alternative treatment prior to completing the first cycle of treatment.||percentage of responding participants|||Number
111363|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-I scale:~1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
111364|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-S scale:~1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
111365|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4||At baseline and at Week 4|Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||beats per minute||Standard Deviation|Mean
111366|NCT00723190|Primary|Change From Baseline in Heart Rate at Week 4|Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||beats per minute||Standard Deviation|Mean
111367|NCT00723190|Primary|Change From Baseline in Body Temperature at Week 4|Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Fahrenheit||Standard Deviation|Mean
111368|NCT00723190|Primary|Change From Baseline in Systolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||mmHg||Standard Deviation|Mean
111369|NCT00723190|Primary|Change From Baseline in Diastolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||mmHg||Standard Deviation|Mean
111370|NCT00723190|Primary|Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12||At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Kilograms||Standard Deviation|Mean
111371|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett’s (QTcB) at Week 4||At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||milliseconds||Standard Deviation|Mean
111372|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Events|||Number
111373|NCT00723190|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12|The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement||Units on a scale||Standard Deviation|Mean
111374|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population||Participants|||Number
111375|NCT00723177|Secondary|The Effects of AV411 on the Analgesic Effects of Oxycodone.|The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.|Measured at the end of each AV411 of the three two-week maintenance periods|||units on a scale||Standard Deviation|Mean
111376|NCT00723177|Primary|Subjective Opioid Withdrawal Scale Score (SOWS)|Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.|Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).|Only 30 of the total number of 44 enrolled completed the study .||units on a scale||Standard Error|Mean
111377|NCT00723125|Secondary|Measure of Safety and Tolerability According to CTC Version 3.0||2 years||||||
111378|NCT00723125|Primary|Pathological Complete Response Rates at Surgery||at surgery approximately 5 months after initial treatment|Cohort1: 33 pts enrolled to cohort 1,33 underwent surgery even if they did not complete all treatment Cohort 2: 27 enrolled to cohort 2 and 27 underwent surgery, even if they did not complete all treatment||participants|||Number
111379|NCT00723073|Secondary|Duration of Neutropenia|Median number of days patients were neutropenic during the study period|11/1/2005 - 10/31/2007|||days||Inter-Quartile Range|Median
111380|NCT00723073|Secondary|Duration of Hospitization|Median number of days patients were hospitalized during the study period|11/1/2005 - 10/31/2007|||days||Inter-Quartile Range|Median
111381|NCT00723073|Secondary|Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation|The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy|11/1/2005 - 10/31/2007|||participants|||Number
111382|NCT00723073|Secondary|Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy|aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5x the upper limit of normal (ULN) or total bilirubin > 3x the upper limit of normal (ULN)|11/1/2005 - 10/31/2007|||participants|||Number
111383|NCT00723073|Secondary|Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)|median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)|11/1/2005 - 10/31/2007|||days||Inter-Quartile Range|Median
111384|NCT00723073|Primary|Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy|Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy|11/1/2005 - 10/31/2007|||participants|||Number
111385|NCT00723073|Primary|Absence of Any Breakthrough Invasive Fungal Disease (IFD)|a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed > 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin|11/1/2005 - 10/31/2007|||participants|||Number
111386|NCT00723073|Primary|Mortality at Hospital Discharge|We assessed all patients in the study cohort who dischaged from the hospital alive|11/1/2005 - 10/31/2007|||participants|||Number
111387|NCT00723073|Primary|Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)|Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia|11/1/2005 - 10/31/2007|||participants|||Number
111388|NCT00723073|Primary|Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)|Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.|11/1/2005 - 10/31/2007|||participants|||Number
111389|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]|AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).|14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.|||||
154744|NCT00339833|Primary|Change in Fasting Plasma Glucose Concentration||7 days|||mmol/l||Standard Deviation|Mean
111390|NCT00723021|Other Pre-specified|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.|||||
111391|NCT00723021|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|||hrs||Full Range|Median
111392|NCT00723021|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
111393|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.||ng*h/mL||Standard Deviation|Mean
111394|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
111395|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L/Sec||Standard Deviation|Mean
111396|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline,24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
111397|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
111398|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
111399|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period||L||Standard Deviation|Mean
111400|NCT00723008|Primary|Mean General Sleep Disturbance Scale (GSDS) Score|The GSDS is a questionnaire used to qualitatively evaluate sleep. This 21-question tool evaluates each aspect of sleep and restfulness on a 0-7 score, indicating the number of days per week that each problem may be present. Total scores range from 0-147, with higher scores indicating more profound disturbances in sleep.|Baseline, Week 4, Week 8|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||Score||Standard Deviation|Mean
111401|NCT00723008|Primary|Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their anxiety level before and after each daily CES treatment. Responses were scored on a scale ranging from 0 (indicating no anxiety) to 10 (worst possible).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval||VAS-A Score||Standard Deviation|Mean
111402|NCT00723008|Primary|Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their pain intensity before and after each daily CES or sham treatment. Responses were scored on a scale ranging from 0 (indicating no pain) to 10 (worst possible pain).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||VAS-P Score||Standard Deviation|Mean
111403|NCT00723008|Primary|Mean Brief Profile of Mood States (BPOMS) Score|BPOMS is a tool used to qualitatively measure anxiety. Subjects were asked to evaluate 30 feelings that they may have had over the past week. Stress-associated feelings are scored on a 5-point Likert scale from 0 (not at all)to 4 (extremely). Six of the feelings listed on the questionnaire are not associated with anxiety and therefore are not scored. Total scores range from 0-96, with higher scores indicating greater tension and anxiety.|Baseline, Week 4, Week 8|One A:Active/Unblinded subject was removed from analysis due to a 39-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||Brief POMS Score||Standard Deviation|Mean
111404|NCT00723008|Primary|Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score|This 20-item questionnaire measures depressive symptoms. Scores can range from 0-60, with scores greater than 16 indicating need for further evaluation due to possible Major Depression.|Baseline, 4 Weeks, 8 Weeks|One A:Active/Unblinded subject was removed from analysis due to a 31-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.||Score||Standard Deviation|Mean
111405|NCT00723008|Primary|Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score|Subjects were asked to complete questionnaire three times during the course of study. Questions addressed symptoms associated with Post Traumatic Stress Disorder(PTSD). Scores can range from 17 to 85. A score >31 was used to identify symptomatic subjects and was therefore required at baseline for study enrollment.|Baseline, Week 4, Week 8|All active subjects||Score||Standard Deviation|Mean
111424|NCT00722371|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
111406|NCT00722566|Secondary|Number of Patients With Complete Response|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks."|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.||Participants|||Number
111407|NCT00722566|Primary|Number of Patients With Overall Response (Complete Response + Partial Response)|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.~Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg"|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.||Participants|||Number
111408|NCT00722553|Secondary|Overall Survival (OS)|The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.|Analysis per protocol. Patients who had not died or were lost to follow-up were censored||Months||95% Confidence Interval|Median
111409|NCT00722553|Secondary|Progression Free Survival (PFS)|Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.||Months||95% Confidence Interval|Median
111410|NCT00722553|Secondary|Clinical Benefit Rate (CBR)|The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)|Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.|||participants|||Number
111411|NCT00722553|Secondary|Duration of Response (DOR)|Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.|Measured from the first day of documented response for up to 2 years after enrollment.|Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)||Days||95% Confidence Interval|Median
111412|NCT00722553|Primary|Objective Response Rate (ORR)|The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.|||participants|||Number
111413|NCT00722436|Secondary|Platelets||baseline, after osteotomies, immediately after surgery|||10^9 platelets/L||Standard Deviation|Mean
111414|NCT00722436|Secondary|Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).||(baseline, after osteotomies, and immediately after procedure)|||seconds||Standard Deviation|Mean
111415|NCT00722436|Primary|Number of Patients That Remained Transfusion Free||24 hours|||participants|||Number
111416|NCT00722436|Primary|Total Volume (ml/kg) of Allogeneic Blood Exposure.|This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.|intraoperative and postoperative (24 hr)|||ml/kg||Standard Deviation|Mean
111417|NCT00722423|Secondary|Antiviral Treatment Rate|Number of patients started antiviral treatment|12-24 weeks post-treatment|||percentage of participants|||Number
111418|NCT00722423|Primary|Sustained Virologic Response Rates|Virus not detected by PCR assay|12-24 weeks post-treatment|||participants|||Number
111419|NCT00722371|Secondary|Change From Baseline in 2-Hour PMG at Week 54|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
111420|NCT00722371|Secondary|Change From Baseline in FPG at Week 54||Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
111421|NCT00722371|Primary|Change From Baseline in A1C at Week 54|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
111422|NCT00722371|Secondary|Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
111423|NCT00722371|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24||Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.||mg/dL||95% Confidence Interval|Least Squares Mean
111425|NCT00722137|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug.|Up to Week 28|The safety population was defined as all randomized participants who received at least 1 dose of study medication.||Participants|||Number
111426|NCT00722137|Secondary|18-Month Survival|18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).|Up to month 18 from the time of randomization|The population consisted of all radmonized participants.||Percentage of Participants||95% Confidence Interval|Mean
111427|NCT00722137|Secondary|Overall Survival (OS)|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
111428|NCT00722137|Secondary|Overall Complete Response (CR + CRu)|Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). ). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.||Participants|||Number
111429|NCT00722137|Secondary|Overall Response Rate (ORR)|ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.||Participants|||Number
111430|NCT00722137|Secondary|Treatment-free Interval (TFI)|The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.|Median duration of follow-up of 40 months|All randomized participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
111431|NCT00722137|Secondary|Time to Next Anti-lymphoma Treatment (TTNT)|The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.|: Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
111432|NCT00722137|Secondary|Duration of Response|The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had >= 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.||Days||95% Confidence Interval|Median
111433|NCT00722137|Secondary|Time to Progression (TTP)|Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
111434|NCT00722137|Primary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.||Days||95% Confidence Interval|Median
111435|NCT00722124|Primary|7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)|7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide <8ppm)|8 weeks|Analysis was performed using intention to treat(ITT). Subjects who discontinued study participation were assumed to be smoking.||participants|||Number
111436|NCT00722072|Secondary|Safety and Tolerability Profile||Continuous throughout study and 28 to 56 days after discontinuation of study therapy||||||
111437|NCT00722072|Secondary|Overall Survival||28 to 56 days after discontinuation of study therapy||||||
111438|NCT00722072|Secondary|Progression-free Survival||Start of treatment to time of progression or death, whichever comes first.||||||
111439|NCT00722072|Secondary|Time to Progression||Start of treatment to time of progression.||||||
111440|NCT00722072|Secondary|Objective Response Rate||Every 8 weeks (two cycles) while receiving study therapy.||||||
111456|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
111934|NCT00717977|Primary|Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.|48-72 hours|||mg/dL||Standard Deviation|Mean
111441|NCT00722072|Primary|Number of Participants With Progression-free Survival at 4 Months|Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).|4 months after initiating treatment with sorafenib plus fulvestrant.|||Participants|||Number
111442|NCT00722020|Secondary|Secondary Endpoint Total Hospital Length of Stay|Seconadary endpoint was Total Hospital length of stay|30 Days|||days||Standard Deviation|Mean
111443|NCT00722020|Primary|The Primary Endpoint Will be Time to Readiness for Discharge.|Days in the hospital prior to patient being clinically ready to discharge|30 days|asthmatic children||days||Standard Deviation|Mean
111444|NCT00721968|Other Pre-specified|Number of Ocular Hypotensive Medications by Visit||12 months|||medications||Standard Deviation|Mean
111445|NCT00721968|Primary|Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications|Percent reaching this endpoint|12 months|Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications||participants|||Number
111446|NCT00721734|Secondary|Time to Progression (TTP)|Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods.|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population||months||95% Confidence Interval|Median
111447|NCT00721734|Secondary|Duration of Response|"Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death.~Progressive disease was defined as any of the following:~An increase of more than 25% from nadir in any one of the following:~M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL);~Urine (the absolute increase had to be ≥ 200 mg/24 hours);~The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be > 10 mg/dL);~≥ 10% bone marrow infiltration by plasma cells;~Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas.~Median duration of response was estimated using the Kaplan-Meier method."|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.||months||95% Confidence Interval|Median
111448|NCT00721734|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks.|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population||percentage of participants||95% Confidence Interval|Number
111449|NCT00721734|Secondary|Overall Response Rate (ORR)|"ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma.~sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and < 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of < 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline."|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population included all participants with measurable disease and a baseline and at least 1 post-baseline disease assessment or who discontinued study treatment due to a related adverse event prior to obtaining an on-study disease assessment.||percentage of participants||95% Confidence Interval|Number
111450|NCT00721734|Secondary|Plasma Protein Binding (PPB) of Carfilzomib|The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15).|End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15|Participants with available data||percentage of carfilzomib bound||Standard Deviation|Mean
111451|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
111452|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
111453|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
111454|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data||percentage of carfilzomib dose||Standard Deviation|Mean
111455|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
116614|NCT00677820|Secondary|Number of Subjects Reporting Any AEs Post Treatment||Days 0-14|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
111457|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
111458|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
111459|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
111460|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population; AUCinf could not be estimated for 11 participants in the PK population who did not have adequate PK data.||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
111461|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
111462|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data||ng/mL||Geometric Coefficient of Variation|Geometric Mean
111463|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
111464|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data||liters/hour||Standard Deviation|Mean
111465|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data||liters/hour||Standard Deviation|Mean
111466|NCT00721734|Primary|Clearance (CL) of Carfilzomib on Day 1 of Cycle 1|Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.|Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|"The pharmacokinetic (PK) evaluable population includes participants with stable baseline renal function (Arms 1–4) who completed all protocol-specified treatment and PK blood sample collection through Cycle 1, Day 16. In Group 5, only samples collected before dialysis were included.~CL could not be estimated for 11 patients in the PK population."||liters/hour||Standard Deviation|Mean
111467|NCT00721617|Secondary|C-peptides Levels for Intralipid/Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
111468|NCT00721617|Secondary|C-peptides Levels for Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
111469|NCT00721617|Secondary|C-peptides Levels for Intralipid Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after Intralipid infusion, and 8 hours after Intralipid infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
111935|NCT00717977|Primary|Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.|48-72 hours|||mg/dL||Standard Deviation|Mean
111470|NCT00721617|Secondary|C-peptides Levels for Saline Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours|||ng/mL||Standard Deviation|Mean
111471|NCT00721617|Secondary|Insulin Levels for Intralipid/Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
111472|NCT00721617|Secondary|Insulin Levels for Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
111473|NCT00721617|Secondary|Insulin Levels for Intralipid Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
111474|NCT00721617|Secondary|Insulin Levels for Saline Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours|||μU/mL||Standard Deviation|Mean
111475|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid/Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
111476|NCT00721617|Secondary|Plasma Glucose Levels for Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
111477|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 8 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 8 hours|||mmHg||Standard Deviation|Mean
111478|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 4 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 4 hours|||mmHg||Standard Deviation|Mean
111479|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
111480|NCT00721617|Secondary|Plasma Glucose Levels for Saline Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours|||mg/dL||Standard Deviation|Mean
111481|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 8 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.|Baseline, 8 hours|||mg/dL||Standard Deviation|Mean
111482|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 4 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.|Baseline, 4 hours|||mg/dL||Standard Error|Mean
111483|NCT00721617|Secondary|Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.|Baseline, 8 hours|||mmol/L||Standard Deviation|Mean
111484|NCT00721617|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.|Baseline, 4 hours|||mmol/L||Standard Deviation|Mean
111485|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 8 Hours|Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 8 hours|||mmHg||Standard Error|Mean
111486|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 4 Hours|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 4 hours|||mmHg||Standard Error|Mean
111487|NCT00721617|Primary|Change in Flow-mediated Dilation From Baseline to 4 Hours|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.|Baseline, 4 hours|||percent change in diameter||Standard Deviation|Mean
111488|NCT00721578|Secondary|Medication Administration|Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration.|Up to 9 months|FAS.||Participants|||Number
111489|NCT00721578|Secondary|Median Duration of Antifungal Therapy||Up to 9 months|FAS.||Days||Full Range|Median
111490|NCT00721578|Secondary|Concomitant Medications||Up to 9 months|FAS.||Participants|||Number
111491|NCT00721578|Primary|Number of Participants With Mycological Outcomes|"Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy~), or unknown (results are not available/not known) as assessed by the Investigator/Physician."|Up to 9 months|FAS.||Participants|||Number
111492|NCT00721578|Primary|Number of Participants With Clinical Outcomes.|"Clinical outcomes, as assessed by the investigator, defined as:~Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period.~Deteriorated: clinical signs and symptoms of fungal infection worsened (including death).~Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation."|Up to 9 months|FAS.||Participants|||Number
111493|NCT00721578|Primary|Total Daily Dose for Selected Antifungal Agent||Up to 9 months|FAS. Data were not analyzed.||mg|||Number
111494|NCT00721578|Primary|Management of SFI: Reason for Selection of Antifungal Agent|Number of participants with reason for investigator's selection of particular antifungal therapy.|Up to 9 months|FAS. Data were not analyzed.||Participants|||Number
111495|NCT00721578|Primary|Management of SFI: Choice of Treatment|Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.|Up to 9 months|FAS.||Participants|||Number
111496|NCT00721578|Primary|Diagnosis of Systemic Fungal Infection (SFI)|Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.|Up to 9 months|Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment||Participants|||Number
111497|NCT00721539|Secondary|Average Operative Time|Average operative time in minutes|Up to four hours (240 minutes)|Participants||Minutes||Full Range|Mean
111498|NCT00721539|Secondary|Average Blood Loss|Blood lost during procedure|Duration of procedure up to two hours|Participants||mL||Full Range|Mean
111499|NCT00721539|Secondary|Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure||Six weeks|Adult patients 18 years of age and over||Participants|||Number
111500|NCT00721539|Primary|Overall Complication Rate (Intraoperative and Postoperative)|Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.|Six weeks|Subjects enrolled in this pilot study.||Participants|||Number
111501|NCT00721500|Primary|Lens Tightness on Cornea With Manual Digit Push Up|Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.||percentage|Participants|Standard Deviation|Mean
111502|NCT00721500|Primary|Lens Fit Decentration|Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.||mm|Participants|Standard Deviation|Mean
111503|NCT00721500|Primary|Proportion of Eyes Successfully Fit|Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.||proportion of participant eyes|Participants||Number
111504|NCT00721409|Secondary|Number of Participants With Treatment-Related Adverse Events at Phase 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 41 months)|As treated set included all treated participants classified by the treatment actually received.||Participants|||Number
111505|NCT00721409|Secondary|Number of Participants With TEAEs (All Causalities) at Phase 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent adverse events were those with initial onset or that worsen in severity after the first dose of study medication.|Maximum treatment duration (approximately 41 months)|As treated set included all treated participants classified by the treatment actually received.||Participants|||Number
111506|NCT00721409|Secondary|Percentage of Participants With Tumor Expression of CYP19A1 and CCND1 Genotypes at Phase 2|One 2-mL blood specimen was collected for the analysis of germline polymorphism in CYP19A1 and CCND1 genes. A single nucleotide polymorphism (SNP) rs4646 as defined in the National Center for Biotechnology Information (NCBI) database in the aromatase gene (CYP19A1) was analyzed. A germline polymorphism G/A870 (rs9344) in the CCND1 gene was analyzed.|Screening visit (≤ 28 Days prior to dosing)|Polymorphism analysis set included participants in the safety analysis set who had at least 1 polymorphism assessment.||Percentage of participants|||Number
111507|NCT00721409|Secondary|Summary of Copy Number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) at Phase 2|Gene copy number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) were evaluated. This analysis was done for Phase 2 combined group.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.||Copy number||Standard Deviation|Mean
111508|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Tumor Retinoblastoma (RB) and CyclinD1|Presence or absence of tumor RB and CyclinD1 were evaluated. The following definitions of expression applied in the below table: Positive: any expression >0 and Negative: any expression=0.|Screening visit (≤ 28 Days prior to dosing)|Protein biomarkers analysis set included all participants in the safety analysis set who had at least protein biomarker assessment.||Participants|||Number
111509|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Ki67|Frequency of tumor tissue biomarker Ki67 was evaluated in across treatment groups.|Screening visit (≤ 28 Days prior to dosing)|All participants in the Safety Analysis set who had a Ki67 protein biomarker assessment.||Participants|||Number
111510|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - p16/INK4A, CCND1|Tissue samples were used for retrospective biomarker analyses. For Phase 2 Part 2, the tissue samples were sent to a central laboratory for the assessment of participant selection biomarkers. For Phase 2 Part 1, the assessment of the biomarkers (CCND1 amplification and/or loss of p16) were performed retrospectively from the available samples.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.||Participants|||Number
111511|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Interference Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.||Units on a scale||Standard Error|Mean
111512|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Severity Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.||Units on a scale||Standard Error|Mean
111936|NCT00717977|Primary|Overall Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.|48-72 hours|||mg/dL||Standard Deviation|Mean
111513|NCT00721409|Secondary|Time to Tumor Progression (TTP) at Phase 2-Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
111514|NCT00721409|Secondary|Number of Participants With CBR at Phase 2 - Investigator Assessment|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized patients from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
111515|NCT00721409|Secondary|Duration of Response at Phase 2 - Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|A subset of ITT population i.e., participants who had response was used for this analysis.||Months||95% Confidence Interval|Median
111516|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response in Participants With Measurable Disease at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions. Measurable disease referred to the lesions that was accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10-16 mm with spiral computer tomography scan (depending on reconstruction interval). Clinical lesions were only be considered measurable when they were superficial (eg, skin nodules, palpable lymph nodes).|From randomization up to the end of treatment (approximately 41 months)|Participants in ITT population with measurable disease were used.||Percentage of participants||95% Confidence Interval|Number
111517|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Percentage of participants||95% Confidence Interval|Number
111518|NCT00721409|Secondary|Overall Survival (OS) at Phase 2|Time in weeks or months from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7 or 30.44 if in months.|From randomization until death (assessed up to 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
111519|NCT00721409|Secondary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval at Phase 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR), by Bazette’s formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|Cycle 1 Day 1 prior to dosing, Cycle 1 Day 14 (2, 4 [prior to meal], 8, 24, 48, and 96 hours after dosing of Palbociclib), Cycle 2 Day 1 and Day 14 (prior to and 4 hours after dosing of letrozole)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
111520|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Tmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||Hour||Full Range|Median
111553|NCT00721253|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 months|||log units||Standard Deviation|Mean
111521|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Cmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
111522|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: AUC24 at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
111523|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Volume of Distribution (Vz/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||L||Geometric Coefficient of Variation|Geometric Mean
111524|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Clearance (CL/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||L/hr||Geometric Coefficient of Variation|Geometric Mean
111525|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Terminal Plasma Half-life (t1/2) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||Hour||Standard Deviation|Mean
111526|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Time to Maximum Plasma Concentration (Tmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||Hour||Full Range|Median
111527|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Maximum Observed Plasma Concentration (Cmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
111528|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
111937|NCT00717886|Primary|Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).||2 years|||participants|||Number
111938|NCT00717873|Primary|Hospital Length of Stay||Admission to Discharge|||days||Standard Deviation|Mean
111529|NCT00721409|Secondary|Percentage of Participants With Clinical Benefit Response (CBR) at Phase 1|CBR is defined as a confirmed CR, confirmed PR, or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 weeks after initial response.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.||Percentage of participants||95% Confidence Interval|Number
111530|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Tumor Response at Phase 1|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.||Percentage of participants||95% Confidence Interval|Number
111531|NCT00721409|Primary|Progression-Free Survival (PFS) at Phase 2 - Investigator Assessment|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Weeks or Months) = (first event date minus randomization or the first dose date plus 1) divided by 7 (or 30.44 if in months). PFS is usually characterized by the median, 25% percentile,75% percentile and their 95% Confidence Intervals (CIs).|From randomization date to date of first documentation of progression or death (assessed up to 41 months)|Intent-to-Treat (ITT) was used. This represented all randomized participants from Ph2P1 or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||Months||95% Confidence Interval|Median
111532|NCT00721409|Primary|Number of Participants With Dose Limiting Toxicities at Phase 1|Dose limiting toxicity was defined as any of the following TEAEs occurring during the second cycle of treatment and possibly attributable to the combination of letrozole plus Palbociclib: 1. Grade 4 hematologic toxicity (including platelets <25,000/μL, ANC <500/μL). 2. Grade 3 neutropenia associated with a documented infection or fever ≥38.5°C. 3. Grade ≥3 non-hematologic toxicities, except those that have not been maximally treated (eg, nausea, vomiting, diarrhea, hypertension). 4. Delay by ≥1 week in receiving the next scheduled dose of either study treatment due to persisting treatment-related toxicities (platelet count <50,000/μL; ANC <1,000/μL; nonhematologic toxicities of Grade ≥3 severity). 5. Inability to deliver at least 80% of the planned Palbociclib or letrozole doses during Cycle 2 due to toxicity possibly attributable to the study treatment.|Cycle 2 (4 weeks)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
111533|NCT00721409|Primary|Number of Participants With Treatment-Related Adverse Events at Phase 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
111534|NCT00721409|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) at Phase 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.||Participants|||Number
111535|NCT00721396|Secondary|Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.|"Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.~Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies."|1 month after 3rd vaccination|||Percentages of subjects||95% Confidence Interval|Number
111536|NCT00721396|Secondary|Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|One month after third Men B vaccination|PP Population||Percentages of subjects||95% Confidence Interval|Number
111537|NCT00721396|Secondary|Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.|The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.|One month after third Men B vaccination|PP Population||Percentages of subjects||95% Confidence Interval|Number
111538|NCT00721396|Secondary|Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|one month after third Men B vaccination|PP Population||Ratio||95% Confidence Interval|Geometric Mean
111539|NCT00721396|Secondary|Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.|One month after third Men B vaccination|PP Population||Titers||95% Confidence Interval|Geometric Mean
111540|NCT00721396|Secondary|Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine|Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.|One month after 3rd vaccination|All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis: Per Protocol (PP) Population.||Percentages of subjects||95% Confidence Interval|Number
111541|NCT00721396|Secondary|Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age|The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.|One month after 3rd Men B vaccination|Analysis was done on the per-protocol population i.e all subjects in the MITT population who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
111542|NCT00721396|Primary|Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age|Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).|10 months (groups 1 and 2); 8 months (groups 3 and 4)|All subjects receiving at least one injection and providing post-baseline safety data (Safety Set).||Number of subjects|||Number
111543|NCT00721396|Primary|Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine|"The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).~The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains."|One month after third Men B vaccination|The analysis was done on the Modified Intention to Treat (MIIT) population, ie, enrolled subjects who actually received a study vaccination and provided at least one evaluable serum sample after baseline.||Percentages of subjects||95% Confidence Interval|Number
111544|NCT00721357|Secondary|Magnetic Resonance Spectroscopy of Muscle Metabolic Properties||within one week of enrollment||||||
111545|NCT00721357|Secondary|Muscle Mechanical Energy Expenditure|mechanical work done by lower extremity joints|one time measure||12/2015||||
111546|NCT00721357|Primary|Oxygen Consumption During Walking|Amount of oxygen consumed during walking at self-selected speed normalized to speed|within one week of enrollment|||ml/kg/min||Standard Deviation|Mean
111547|NCT00721279|Primary|Correlation of the Change in IRLS at End of Titration and at Final Visit|Correlation of the change in IRLS at end of titration and at final visit|Up to 12 weeks|Full Analysis Set (FAS)||percentage of patients|||Number
111548|NCT00721279|Primary|Frequency of Adverse Events|Frequency of patients with any adverse event, causally related adverse events and serious adverse events|Up to 16 weeks|Safety Analysis Set (SAF)||participants|||Number
111549|NCT00721279|Primary|Change in Global Clinical Impression - Improvement (CGI-I) Scale|The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient’s illness has improved or worsened relative to a baseline state. A patient’s illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse|baseline and final visit (week 12)|Full analysis set||percentage of participants|||Number
111550|NCT00721279|Primary|Change in Total Scores of IRLS (International Restless Legs Rating Scale)|"The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.~The change from baseline was calculated as baseline minus the week 12 value."|Baseline and final visit (week12)|Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included||scores on a scale||Inter-Quartile Range|Median
111551|NCT00721279|Primary|Frequency Analysis for Baseline Pattern of RLS Symptoms|Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.|Baseline|Full analysis set (FAS)||percentage of participants|||Number
111552|NCT00721253|Secondary|Defocus Curve|Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months post-operative|||logMAR||Standard Deviation|Mean
112043|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||sputum @ 7 hours||||||
111554|NCT00721253|Primary|Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate|Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|6 months|||logMAR||Standard Deviation|Mean
111555|NCT00721227|Secondary|Weight Loss Following Reduction Gastroplasty|Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.|12 months|Includes only participants who completed month 12 visit.||Percentage of weight loss||Standard Deviation|Mean
111556|NCT00721227|Secondary|Durability of Gastric Plications Following Reduction Gastroplasty|The number of participants who completed month 12 gastroscopies showing intact plications.|12 month|Includes only participants who completed month 12 gastroscopy.||participants|||Number
111557|NCT00721227|Primary|Successful Gastric Plication Using Reduction Gastroplasty|The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.|Immediately post-operative|||participants|||Number
111558|NCT00721214|Secondary|Two-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with two year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two- year event-free survival rate is the same as for overall survival, 37% (SE = 14.3%).|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
111559|NCT00721214|Secondary|One-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with one year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated one-year event-free survival rate is the same as for overall survival, 47% (SE = 13.6%).|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
111560|NCT00721214|Secondary|Two-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts.|Percentage of participants alive two years after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two year survival rate is 37% .The estimated two-year overall survival rate is the same as two-year event free survival.|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
111561|NCT00721214|Primary|Two Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival. The percentage of patients was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated two-year event-free survival rate is the same as overall survival, 50%.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
111562|NCT00721214|Primary|One Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival, as estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated one-year event-free survival rate is the same as overall survival, 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
111563|NCT00721214|Primary|Two Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive two years after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated two year survival rate is 50%, the same as one year survival rate.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
111564|NCT00721214|Secondary|One-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants alive one year after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored. The estimated one year overall survival rate from this curve is 47%. The one year overall survival is the same as one year event free survival rate.|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
111565|NCT00721214|Primary|One Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive one year after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated one year survival rate from this curve is 50%, while the estimated two year survival rate is 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.||percentage of participants||95% Confidence Interval|Number
111566|NCT00721188|Secondary|Number of Participants With Serious Adverse Events (SAE's)||Day of initial treatment with Venofer through 30 days after study treatment|||participants|||Number
111567|NCT00721188|Secondary|Mean Residence Time (MRtime)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||hour||Standard Deviation|Mean
111568|NCT00721188|Secondary|Volume of Distribution at Steady State (Vdss)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||dL||Standard Deviation|Mean
111569|NCT00721188|Secondary|Volume of Distribution Based on the Terminal Phase (Vdarea)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||dL||Standard Deviation|Mean
111570|NCT00721188|Secondary|Initial Volume of Distribution (Vdc)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||dL||Standard Deviation|Mean
111571|NCT00721188|Secondary|Total Body Clearance (Cl)|Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)|Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.|||dL/hour||Standard Deviation|Mean
111572|NCT00721188|Primary|Terminal Phase Elimination Rate Constant (λz)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||1/hour||Standard Deviation|Mean
111573|NCT00721188|Primary|Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||ug/dL||Standard Deviation|Mean
111574|NCT00721188|Primary|Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||ug*hr/dL||Standard Deviation|Mean
111575|NCT00721188|Primary|Serum Terminal Phase Elimination Half-life (T1/2)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||hour||Standard Deviation|Mean
111576|NCT00721188|Primary|Time to Maximum Serum Concentration (Tmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||hour||Standard Deviation|Mean
111577|NCT00721188|Primary|Maximum Observed Serum Concentration (Cmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.|||ug/dL||Standard Deviation|Mean
111578|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.|at 2 weeks and 4 weeks after stent insertion|91 participants who had successful stent insertion were analyzed based on per protocol analysis.||proportion of participants||95% Confidence Interval|Mean
111579|NCT00721175|Secondary|Cost Effective Ratio of Metallic and Plastic Stent|cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature|until the patients expire (Markov model)|Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma||cost (US$) per QALY|||Number
111580|NCT00721175|Secondary|Patients Survival Times|survival times of the patients after the first stent insertion|until patient died or 6 months after the last patient was enrolled|||days||Inter-Quartile Range|Median
111581|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.|at 2 weeks and 4 weeks after stent insertion|All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)||proportion of participants||95% Confidence Interval|Mean
111582|NCT00721162|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 30 months|All participants who received any amount of study drug.||participants|||Number
111583|NCT00721162|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 43.9 months|All participants who received any amount of study drug. The number of participants censored was 12.||months||95% Confidence Interval|Median
111584|NCT00721162|Secondary|Overall Survival at 1 Year (OS-1)|Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.|First dose to 12 months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
111639|NCT00720798|Secondary|Percentage of Participants Who Withdrew From Treatment||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.||Percentage of participants|||Number
112044|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).||Before inhalation both evaluations (0 hours)||||||
111585|NCT00721162|Secondary|Progression-Free Survival (PFS)|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 34.6 months|All participants who received any amount of study drug. The number of participants censored was 11.||months||95% Confidence Interval|Median
111586|NCT00721162|Primary|Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)|Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
111587|NCT00721162|Primary|Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)|Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.|First Dose to 6 Months|All participants who received any amount of study drug.||percentage of participants||95% Confidence Interval|Number
111588|NCT00721149|Secondary|Percentage of Subjects Who Responded to Quality of Life Assessment|SF 36 Symptom Frequency and Severity Checklist|1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.|||||
111589|NCT00721149|Secondary|TTM Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.|||||
111590|NCT00721149|Secondary|24-hour Holter Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.|||||
111591|NCT00721149|Secondary|Percentage of Subjects Who Achieved Acute Success|Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.|Day 91 - 361|The subjects who had a study ablation procedure.||Percentage of participants|||Number
111592|NCT00721149|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.|within 7 days of ablation procedure|The subjects who had a study ablation procedure.||Percentage of participants|||Number
111593|NCT00721149|Primary|Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.|A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).|From study day 91 through day 361|The subjects who had a study ablation procedure.||Percentage of participants|||Number
111594|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks|The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Percentage of Participants|||Number
111595|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks|"Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis.~FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Percentage of Participants|||Number
111640|NCT00720798|Primary|Percentage of Participants With ≥ 1 Adverse Event||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.||Percentage of participants|||Number
111596|NCT00721123|Primary|Overall Death Rate Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1.~To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure."|through 264 Weeks|All exposure population, which included all participants who entered the study and received at least one dose of tocilizumab at any time.||Deaths per 100 PY||95% Confidence Interval|Number
111597|NCT00721123|Primary|Summary Adverse Event Rates Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied.~Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed “unrelated” to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity.~Medical confirmation of the AESI GI perforation was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Adverse Events per 100 Patient Years||95% Confidence Interval|Number
111598|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks|The patient’s assessment of the patient's current level of pain on a 100 mm horizontal VAS was recorded. The extreme left end of the line was described as “no pain” and the extreme right end as “unbearable pain”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
111599|NCT00721123|Secondary|Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Physician’s global assessment of disease activity is the treating physician’s assessment of the patient’s current disease activity on a 100 mm horizontal visual analogue scale (VAS). The extreme left end of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end as “maximum disease activity”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
111600|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Patient’s global assessment of disease activity is the patient’s overall assessment of their disease activity during specified time periods on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme as “maximum disease activity” (maximum arthritis disease activity). Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
111601|NCT00721123|Secondary|Change From Baseline in Scores for Health Assessment Questionnaire − Disability Index Over Time, Through 264 Weeks|"The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.~To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Units on a Scale||Standard Deviation|Mean
111602|NCT00721123|Secondary|Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks|"Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement.~A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.||Joints||Standard Deviation|Mean
111603|NCT00721123|Secondary|Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks|Participants were classified as responders based on a European League Against Rheumatism (EULAR) response of Good or Moderate. Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR response criteria take into consideration both the first score and the change in score in order to classify them as good response, moderate response or no response. The percentage of participants who were classified as responders was recorded, as posted below.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Percentage of Participants|||Number
133919|NCT00524680|Secondary|Toxicity|Number of treated patients that had serious adverse events.|Baseline, at 1, 3 and 6 months|All treated and eligible patients||participants|||Number
111604|NCT00721123|Secondary|Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks|The disease activity score 28 (DAS28) is a combined index for measuring disease activity in rheumatic arthritis (RA) that includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The DAS28 scale ranges from 0 to 10, where lower scores represent less disease activity. Participants with DAS28 scores less than 2.6 were categorized as responders with remission and those with DAS 28 scores of 3.2 or less were categorized as responders with low disease activity (LDA). The percentage of participants classified as responders in each category was recorded over time.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Percentage of Participants|||Number
111605|NCT00721123|Secondary|Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks|"The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.~Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms.~Scores on the ACR scale may be up to ACR100 because the number after “ACR” is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score – that percentage of improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab, with a score at the given time point.||Percentage of Participants|||Number
111606|NCT00721123|Primary|Adverse Event (AE) Summary Over Time|The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.||Participants|||Number
111607|NCT00720941|Secondary|MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.|Weeks 4, 10, 16, and 22|ITT Population. Only those participants who had NSLVs, NSRVs, HHVs, and medical procedures were analyzed.||visits||Standard Deviation|Mean
111608|NCT00720941|Secondary|Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24|Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician’s assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.|From Day 1 up to Week 24|ITT Population. Only those participants who had non-study medical visits, telephone consulations, days in the hospital, and ER visits were analyzed.||events per 30 days||Standard Deviation|Mean
111609|NCT00720941|Secondary|Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The CTSQ assesses 3 domains related to the participant’s satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.|Weeks 4, 10, 16, and 22|ITT Population. Participants missing scores at early time points were excluded from the analysis at those time points. Mean total score was calculated at each assessment week.||Scores on a scale||Standard Deviation|Mean
111610|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
111641|NCT00720759|Primary|Wolf Motor Function Test (Time)|The Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one’s forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task. Score range on the WMFT-T is 0-120, lower scores being better.|3 months after completion of treatment|||units on a scale||Standard Deviation|Mean
111642|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 2|Mean terminal half-life (±SD)|Up to 205 hours|All participants||hours||Standard Deviation|Mean
111643|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 1|Mean Cmax (±SD)|At 1 - 2 hours|All participants||ng/mL||Standard Deviation|Mean
111611|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
111612|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of  In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness? by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
111613|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
111614|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions (I am able to work, I am able to enjoy life, and I am content with the quality of my life now) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
111615|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions (I have nausea, I have diarrhea, and I am bothered by side effects of treatment) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
111616|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of I worry that my condition will get worse by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
111644|NCT00720629|Secondary|Overall Survival (OS)|Median OS in days. Survival was measured from the time of transplant to the time of death.|At 2 years and 5 years|Participants who had died by Year 2 and additional participants who had died by Year 5.||days||Full Range|Median
112402|NCT00712335|Primary|Sputum Neutrophil Percentages|Week 24 sputum neutrophil percentages were measured in active treatment groups.|24 weeks|We will be using intention-to-treat and per protocol for analysis.||percentage of neutrophils||Standard Deviation|Mean
111617|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions (I have a lack of energy, I feel pain, for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.||Scores on a scale||Standard Deviation|Mean
111618|NCT00720941|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.|Baseline (predose); Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at some of the other early time points were excluded from the analysis at those time points.||Scores on a scale||Standard Deviation|Mean
111619|NCT00720941|Secondary|Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)|See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.|From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)|Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.||Participants|||Number
111620|NCT00720941|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)|ITT Population. Only those participants who had either a confirmed CR or PR were analyzed.||Months||95% Confidence Interval|Median
111621|NCT00720941|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)|ITT Population. Only those participants who experienced either a confirmed CR or a PR were analyzed.||Weeks||95% Confidence Interval|Median
111622|NCT00720941|Secondary|Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review|The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.|From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)|ITT Population||Participants|||Number
111623|NCT00720941|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death (up to Study Week 268)|ITT Population. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.||Months||95% Confidence Interval|Median
111624|NCT00720941|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.|From randomization until the earliest date of disease progression or death (up to Study Week 191)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.||Months||95% Confidence Interval|Median
111645|NCT00720629|Secondary|Incidence of Rituximab Response to Reactivated EBV Without PTLD|"Participants who developed plasma EBV-DNA of >1000 copies/mL on any tests received rituximab.~Incidence of Rituximab Response: Reactivated EBV participants whose plasma titers cleared after rituximab, without post-transplant lymphoproliferative disorder (PTLD)."|100 days|Reactivated EBV participants||participants|||Number
111625|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264|The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
111626|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264|The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
111627|NCT00720798|Secondary|Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
111628|NCT00720798|Secondary|Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
111629|NCT00720798|Secondary|Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
111630|NCT00720798|Secondary|Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Erythrocyte sedimentation rate (ESR) was determined locally.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||mm/h||Standard Deviation|Mean
111631|NCT00720798|Secondary|Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Units on a scale||Standard Deviation|Mean
111646|NCT00720629|Secondary|Incidence of Epstein-Barr Virus (EBV) Reactivation|Number of participants who reactivated EBV. Patients had their plasma tested once weekly using the TaqMan polymerase chain reaction (PCR) for quantitative determination of EBV-DNA for 6 weeks. Plasma levels > 1000 copies per ml plasma were scored as positive.|3 months|All participants||participants|||Number
111632|NCT00720798|Secondary|Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Participant’s made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). The participant’s treating physician made a global assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). Participant’s made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated “no pain” (score = 0) and the right end of the scale indicated “unbearable pain” (score = 100).|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||mm||Standard Deviation|Mean
111633|NCT00720798|Secondary|Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Joints||Standard Deviation|Mean
111634|NCT00720798|Secondary|Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
111635|NCT00720798|Secondary|Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264|A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
111636|NCT00720798|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.||Percentage of participants|||Number
111637|NCT00720798|Secondary|Percentage of Participants Who Changed From Monotherapy to Combination Therapy|Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator’s practice and as tolerated by the patient, at any time during this study.|Baseline to Week 296|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.||Percentage of participants|||Number
111638|NCT00720798|Secondary|Percentage of Participants With Concomitant Oral Corticosteroid Therapy|"Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count.~The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months."|Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.||Percentage of participants|||Number
111647|NCT00720629|Primary|Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days|"Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned.~Overall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II"|100 days|All participants||participants|||Number
111648|NCT00720499|Secondary|AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)|"AUC (0-6h) for FEV1, and PEFR (unsupervised) after first dose and after 2 and 4 weeks of treatment were not analysed in the study report because the pertinent information from the unsupervised Pulmonary Function Tests (PFTs) was for the time interval from 6 to 12 hours post-dosing.~FVC peak 0-3h response after the first dose and at Week 2 (supervised) and AUC (6-12h) for FEV1 and PEFR after the first dose and at Week 2 (unsupervised) were not analysed in the study report.~Individual PEFR (supervised) measurements and individual FEV1 and PEFR (unsupervised) measurements at each time point were not analysed in the study report."|4 weeks|No patients analyzed in the study report.|||||
111649|NCT00720499|Secondary|12-lead ECG QT Intervals|"12-lead ECG QT intervals baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
111650|NCT00720499|Secondary|12-lead ECG QTcB Intervals|"12-lead ECG heart rate corrected QT interval, using Bazett method (QTcB), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
111651|NCT00720499|Secondary|12-lead ECG QTcF Intervals|"12-lead ECG corrected heart rate (QT) interval, using Fridericia method (QTcF), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
111652|NCT00720499|Secondary|12-lead ECG QRS Intervals|"12-lead ECG QRS intervals baseline and change from baseline at other time points in milliseconds~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
111653|NCT00720499|Secondary|12-lead ECG PR Intervals|"12-lead ECG PR intervals baseline and change from baseline at other timepoints in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||mS||Standard Deviation|Mean
111654|NCT00720499|Secondary|12-lead ECG Heart Rate|"12-lead Electrocardiogram (ECG) Heart rate baseline and change from baseline values at other time points in Beats Per Minute (BPM)~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS||BPM||Standard Deviation|Mean
111655|NCT00720499|Secondary|Overall Marked Changes From Baseline in Vital Signs|Overall marked changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline to week 14|TS||participants|||Number
111656|NCT00720499|Secondary|Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination|Clinically significant abnormalities for blood chemistry, haematology, urinalysis and physical examination|14 weeks|Treated Set (TS) including all randomized patients who received at least one dose of study medication.||participants|||Number
111657|NCT00720499|Secondary|Physician’s Global Evaluation|"Physician’s global evaluation score on days 15 and 29~The score was evaluated on a 8-points scale :~Poor : 1,2~Fair : 3,4~Good : 5,6~Excellent : 7,8~The presented means are adjusted"|Days 15 and 29|FAS||units on a scale||Standard Error|Mean
111658|NCT00720499|Secondary|Patient Global Rating|"Patient global rating scores treatment comparison after 4 weeks~The score was evaluated on a 7-point scale :~1 : very much better~2 : much better~3 : a little better~4 : no change~5 : a little worse~6 : much worse~7 : very much worse~The presented means are adjusted."|4 weeks|FAS||units on a scale||Standard Error|Mean
111659|NCT00720499|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])|"Weekly mean number of occasions of rescue therapy used per day (as occasion require (PRN) salbutamol [albuterol]) on weeks 1,2,3 and 4.~The means presented are the adjusted mean of weekly mean."|Weeks 1,2,3 and 4|FAS||number of occasions / day||Standard Error|Mean
111660|NCT00720499|Secondary|Weekly Mean Evening PEFR|"Weekly mean evening PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS||Litres / minute||Standard Error|Mean
111661|NCT00720499|Secondary|Weekly Mean Morning PEFR|"Weekly mean morning PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS||Litres / minute||Standard Error|Mean
111662|NCT00720499|Secondary|PEFR AUC (6-12h) Response|"PEFR AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29|FAS||Litres / minute||Standard Error|Mean
111663|NCT00720499|Secondary|PEFR Peak 0-3h Response|"PEFR peak 0-3h response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres / minute||Standard Error|Mean
111664|NCT00720499|Secondary|PEFR AUC (0-3h) Response|"Peak Expiratory Flow Rate (PEFR) AUC (0-3h) response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres / minute||Standard Error|Mean
111665|NCT00720499|Secondary|FVC Peak 0-3h Response|"FVC peak 0-3h response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29|FAS||Litres||Standard Error|Mean
111666|NCT00720499|Secondary|FVC AUC (0-6h) Response|"FVC AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
111667|NCT00720499|Secondary|FVC AUC (0-3h) Response|"FVC AUC (0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres||Standard Error|Mean
111668|NCT00720499|Secondary|Individual FVC Measurements|"Individual FVC measurements [L] at each time point~The categories correspond to the planned times for FVC measurements on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
111669|NCT00720499|Secondary|Trough FVC Response|"Trough Forced Vital Capacity (FVC) response [L] on days 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
111670|NCT00720499|Secondary|FEV1 (Unsupervised) AUC (6-12h) Response|"FEV1 (unsupervised) AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|6 hours (h), 9h and 12h after drug administration on day 29|FAS||Litres||Standard Error|Mean
111671|NCT00720499|Secondary|FEV1, AUC (0-6h) Response|"FEV1, AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
111672|NCT00720499|Secondary|FEV1 Peak 0-3h Response|"FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres||Standard Error|Mean
111673|NCT00720499|Secondary|FEV1 AUC 0-3h, Response|"FEV1 Area Under the Curve (AUC) 0-3h, response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS||Litres||Standard Error|Mean
111674|NCT00720499|Secondary|Individual FEV1 Measurements|"Individual FEV1 measurements [L] at each time point on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS||Litres||Standard Error|Mean
111675|NCT00720499|Secondary|Trough FEV1 Response [L] After 2 Weeks of Treatment|"Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15|FAS||Litres||Standard Error|Mean
112045|NCT00716963|Primary|The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Fall in FEV1.||7 hours after challenge|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.||percentage fall FEV1||Standard Deviation|Mean
111676|NCT00720499|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.|"Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|Full analysis Set (FAS) which included all randomized patients who received at least one dose of study medication and had baseline data and Washout Period for at least 1 efficacy endpoint for each treatment period.||Litres||Standard Error|Mean
111677|NCT00720473|Primary|Means of MADRS Scores at 8 Weeks|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|8 Weeks|MADRS scores were available for 16 bipolar subjects who completed the protocol and 8 healthy controls.||units on a scale||Standard Deviation|Mean
111678|NCT00720473|Primary|Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|Baseline|MADRS scores were available for 27 eligible bipolar subjects and 14 eligible controls.||units on a scale||Standard Deviation|Mean
111679|NCT00720473|Primary|Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||NAA:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
111680|NCT00720473|Primary|Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||Gln:Cr/-10 MADRS Score||95% Confidence Interval|Least Squares Mean
111681|NCT00720473|Primary|Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. The MADRS minimum score is 0 and maximum is 60, with 60 being the most depressed score. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 Weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||Glu:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
111682|NCT00720473|Primary|Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks|||NAA to creatine ratio||95% Confidence Interval|Least Squares Mean
111683|NCT00720473|Primary|Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks|||serum Glutamine to Creatine ratio||95% Confidence Interval|Least Squares Mean
111684|NCT00720473|Primary|Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 Weeks|||serum Glutamate to Creatine ratio||95% Confidence Interval|Least Squares Mean
111685|NCT00720473|Primary|Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline|Estimated changes in least squares mean in the metabolite ratio per 10-point increase in MADRS score. The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|Baseline|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.||Glu:Cr/+10 MADRS||95% Confidence Interval|Least Squares Mean
111686|NCT00720473|Primary|Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.||Mean NAA to creatine ratio||Standard Deviation|Mean
111687|NCT00720473|Primary|Mean Glutamate to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.||mean serum Glutamate to Creatine ratio||Standard Deviation|Mean
111688|NCT00720473|Primary|Mean Glutamine to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.||mean serum Glutamine to Creatine ratio||Standard Deviation|Mean
111689|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.||log10 IU/mL||Standard Deviation|Mean
111690|NCT00720434|Secondary|Population Pharmacokinetics (PK) of PF-00868554|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28||||||
111691|NCT00720434|Secondary|Alanine Aminotransferase (ALT) Levels||Week 4, 12, 48, 72|FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.||IU/L||Standard Deviation|Mean
111692|NCT00720434|Secondary|Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.|Week 4, 12, 48, 60, 72|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.||proportion of participants||95% Confidence Interval|Number
111693|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.||log10 IU/mL||Standard Deviation|Mean
111694|NCT00720382|Other Pre-specified|Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|change from baseline to 12 months|||Units on a scale||Standard Deviation|Least Squares Mean
111695|NCT00720382|Primary|Change From Baseline on Direct Visual Nasal Exams to 12 Months|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|Change from baseline to 12 months|||Participants|||Number
111696|NCT00720369|Secondary|We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.|"The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 question questionnaire which assesses symptom severity of depression. The score is on a 0-60 scale with higher numbers indicating more severe depressive symptoms. The score is represented as a number of points.~Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group."|8 week trial|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.||units on a scale||Standard Deviation|Mean
111697|NCT00720369|Primary|We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).|The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr <---> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.|8 week trial|||per second||Standard Deviation|Mean
111698|NCT00720343|Secondary|Prevalence of Opioid Use||24 hours after surgery||||||
111699|NCT00720343|Secondary|Prevalence of High Blood Choline Concentration||24 hours after surgery||||||
111700|NCT00720343|Secondary|Prevalence of Nausea||24 hours after surgery||||||
111701|NCT00720343|Primary|Prevalence of Pain||24 hours after surgery|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.|||||
111702|NCT00720278|Secondary|Change From Baseline on Direct Visual Nasal Exams|"Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa.~Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation"|14 days|||Participants|||Number
111703|NCT00720278|Secondary|Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 days|||28 item/7 domain RQLQ on 0-6 scale||Standard Deviation|Least Squares Mean
111704|NCT00720278|Secondary|Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days|||Reflective secondary symptom score||Standard Deviation|Least Squares Mean
111720|NCT00720057|Secondary|Summed Pain Intensity Difference at Specific Time Intervals|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.|0-16 hours post dose|Efficacy analyses were based on ITT population (n=312).||units on a scale||Standard Deviation|Mean
111705|NCT00720278|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 Days|||total nasal symptom score||Standard Deviation|Least Squares Mean
111706|NCT00720278|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days|||total nasal symptom score||Standard Deviation|Least Squares Mean
111707|NCT00720122|Primary|Change in Spine Bone Density (g/cm^2)|Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.|Baseline and 6 months|The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol.||gm/cm^2||Standard Error|Mean
111708|NCT00720109|Secondary|Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)|An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.|From the time entry on study to first event or date of last follow-up, assessed up to 7 years|Included in the analysis are two patients who received the drug therapy but were not risk classified.||percentage of patients||90% Confidence Interval|Number
111709|NCT00720109|Secondary|Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation|A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.|At end of consolidation (at 11 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).||Percentage of participants||90% Confidence Interval|Number
111710|NCT00720109|Secondary|Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy|Percent of patients MRD Positive (MRD > 0.01%) at End of Induction.|At the end of induction therapy (at 5 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).||Percentage of participants||90% Confidence Interval|Number
111711|NCT00720109|Primary|Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events|Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)|Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)||Pts with DLTs|||Number
111712|NCT00720109|Primary|Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy|Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.|At 3 years|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).||Percent probability||90% Confidence Interval|Number
111713|NCT00720096|Secondary|Response Rate|Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score ? 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.|1 year, 2 months||||||
111714|NCT00720096|Primary|Interpret Genomic Array|Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.|1 year, 2 months|All patients enrolled 4/4 had biopsiable tumor and sufficient quantity and quality.||Participants|||Number
111715|NCT00720096|Primary|Assess Feasibility|Number of patients meeting 3 week feasibility window which was set as the benchmark.|1 year, 2 months|Patients whose information for treatment was available within the 3 week feasibility window which was set as the benchmark.||Participants|||Number
111716|NCT00720083|Primary|Disease-free Survival|This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.|From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.||||||
111717|NCT00720057|Secondary|Time to Onset of Effect|"Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both perceptible and meaningful pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them."|from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours|Efficacy analyses are based on ITT population (n=312).||hours||Full Range|Median
111718|NCT00720057|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).|at 24 hours postdose or immediately before first use of rescue medication|Efficacy analyses are based on ITT population (n=312).||units on a scale||Standard Deviation|Mean
111719|NCT00720057|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.|postdose to first use of rescue medication|Efficacy analyses are based on ITT population (n=312).||hours||Full Range|Median
111854|NCT00718861|Secondary|Mean of Time to First Clinical Fracture|The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.|over 3 years of study duration|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.||Days||Standard Error|Mean
111721|NCT00720057|Secondary|Total Pain Relief (TOTPAR)|Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.|0-24 hours post dose|Efficacy analyses were based on ITT population (n=312).||units on a scale||Standard Deviation|Mean
111722|NCT00720057|Primary|Summed Pain Intensity Difference (SPID)|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.|0 to 24 hours post dose|Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312).||units on a scale||Standard Deviation|Mean
111723|NCT00719953|Primary|Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|Base line and 12 weeks|||Points on a scale||Standard Error|Mean
111724|NCT00719914|Primary|Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)||30 days|study terminated due to low enrollment|||||
111725|NCT00719901|Secondary|Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either “unrelated or unlikely to be related” to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.|||||
111726|NCT00719901|Secondary|Time to Treatment Failure (Phase II)|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|Time from study entry to the date patients end treatment|No participants proceeded to Phase II for evaluation.|||||
111727|NCT00719901|Secondary|Overall Survival (Phase II)|The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|No participants proceeded to Phase II for evaluation.|||||
111728|NCT00719901|Secondary|Time to Progression (Phase II)|The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time from registration to the time of progression|No participants proceeded to Phase II for evaluation.|||||
111729|NCT00719901|Secondary|Number of Patients Who Have at Least a Partial Response (Phase I)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years|||participants|||Number
111730|NCT00719901|Primary|Proportion of Patients Who Achieve a Partial Response or Better. (Phase II)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.|||||
111731|NCT00719901|Primary|Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)|DLT was defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved. Hematologic DLT measures were assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading.|Up to 21 days of every first course|||Toxicity Incidents|||Number
111732|NCT00719862|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days|||Participants|||Number
111733|NCT00719862|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days|||Units on a scale||Standard Deviation|Least Squares Mean
111734|NCT00719862|Secondary|Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days|||Refecltive secondary symptom score||Standard Deviation|Least Squares Mean
111735|NCT00719862|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days|||total nasal symptom score||Standard Deviation|Least Squares Mean
111736|NCT00719862|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days|||scores on a scale||Standard Deviation|Least Squares Mean
111737|NCT00719862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days|||scores on a scale||Standard Deviation|Least Squares Mean
111738|NCT00719810|Secondary|Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|Clinically Evaluable (CE) patients (see previous definition) with MRSA isolated from screening culture of primary infection.||Participants|||Number
111739|NCT00719810|Primary|Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|The CE population included patients with a diagnosis of cSSSI who received at least 80% of study drug, had a test of cure (TOC) visit 14-21 days after the last dose of study drug, and who did not receive any concomitant, systemic antibacterial therapy with activity against the causative pathogen.||Participants|||Number
111740|NCT00719732|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months|||logMAR||Standard Deviation|Mean
111741|NCT00719706|Secondary|Phosphorus MRS Scans on 4T Scanner|Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level.|Baseline to 12 weeks|At baseline, the number of participants analyzed was the number entered into the imaging portion of the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 10 participants in each category.||units on a scale||Standard Deviation|Mean
111742|NCT00719706|Primary|Clinical Global Impression-Severity|"Scores could range from 0 - 7 units on a scale, with 0 representing the least severe (Normal, not at all ill) and 7 representing the most severe (Among the most extremely ill patients)."|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
111743|NCT00719706|Primary|The Young Mania Rating Scale|The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
111744|NCT00719706|Primary|The Montgomery-Asberg Depression Rating Scale|Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
111745|NCT00719706|Primary|The 25-Item Hamilton Depression Rating Scale.|Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.|Baseline to 15 Weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.||units on a scale||Standard Deviation|Mean
111746|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers|Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
111864|NCT00718809|Secondary|Expected Toxicities Including Skin Rashes and Diarrhea|Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.|Up to 5 years|All patients||participants|||Number
111747|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters|Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
111748|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs|Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.|At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
111749|NCT00719680|Secondary|Number of Subjects Reporting Mild, Moderate, or Severe Local AEs|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
111750|NCT00719680|Secondary|Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion|"The rate of AEs was the number of AEs over the number of infusions administered.~AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion."|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.||AEs per infusion|Participants||Number
111751|NCT00719680|Secondary|Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion|AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.||participants|||Number
111752|NCT00719680|Secondary|Relatedness and Severity of All AEs (Percentage of Total AEs)|"At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.||percentage of total AEs|Participants||Number
111753|NCT00719680|Secondary|Rate of All AEs by Relatedness and Severity|"The rate of AEs was the number of AEs over the number of infusions administered.~At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The All-Treated (AT) safety population comprised all subjects treated with the study medication during any study period.||AEs per infusion|Participants||Number
111754|NCT00719680|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days per subject year|Participants||Number
111755|NCT00719680|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days per subject year|Participants||Number
111756|NCT00719680|Secondary|Number of Days of Hospitalization Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days||Standard Deviation|Mean
111757|NCT00719680|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days per subject year|Participants||Number
111758|NCT00719680|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||days||Standard Deviation|Mean
111759|NCT00719680|Secondary|Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations|Mean of individual median total IgG trough concentration.|Before infusion at Weeks 1, 24, 48, 72, and 96|The ITT population comprised all subjects treated with study medication during any study period.||g/L||Standard Deviation|Mean
111760|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Per-Protocol Efficacy population comprised all subjects who completed at least 48 weeks of the efficacy period that started with the first IgPro20 dose in this study.||infections per subject year|Participants||Number
111761|NCT00719680|Secondary|Annualized Rate of Any Infection|The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.||infections per subject year|Participants||Number
140784|NCT00462826|Primary|6 Month Progression-free Survival|Number of participants who survived progression-free for more than 6 months.|At 6 months|||participants|||Number
111762|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Intention-to-Treat (ITT) population comprised all subjects treated with study medication during any study period.||infections per subject year|Participants||Number
111763|NCT00719615|Primary|Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups.|We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, & 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D < 30 ng/ml.|Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database|"This study is a pilot study to provide preliminary data. Per protocol, we accrued 37% of the sample size needed for a fully powered study. Using the outcome the proportion of persons with vitamin D deficiency, a sample size of 160 subjects (64 nodule, 64 remission, and 32 active) would achieve an 80% power to detect an effect size of 0.25."||participants|||Number
111764|NCT00719563|Secondary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and Week 4|The analysis was not able to be done due to the low numbers of minorities accrued.|||||
111765|NCT00719563|Secondary|Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.||units on a scale||Standard Deviation|Mean
111766|NCT00719563|Secondary|Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.||units on a scale||Standard Deviation|Mean
111767|NCT00719563|Secondary|Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
111768|NCT00719563|Secondary|Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
111769|NCT00719563|Secondary|Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
111770|NCT00719563|Secondary|Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.||units on a scale||Standard Deviation|Mean
111771|NCT00719563|Secondary|Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
140812|NCT00462462|Secondary|Systemic (Cardiopulmonary, Hematological, Metabolic) and Local Outcome of the Two Test Products.||Study end||||||
111772|NCT00719563|Secondary|Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
111773|NCT00719563|Secondary|Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
111774|NCT00719563|Secondary|Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
111775|NCT00719563|Secondary|Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Week 1 to Week 8|Includes all participants that reported at least one value after baseline.||participants|||Number
111776|NCT00719563|Primary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and week 4|Includes all participants who completed both baseline and week 4 assessments.||units on a scale||Standard Deviation|Mean
111777|NCT00719472|Secondary|Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)|Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS).|Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses.||Percentage of participants|||Number
111778|NCT00719472|Secondary|Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)|Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples.|Day 1 of Cycles 2 and either 6 or 8 (last cycle)|Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data.||µg/mL||Standard Deviation|Mean
111779|NCT00719472|Secondary|Duration of Rituximab Infusion Including Dose Interruption Times|The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.|Day 1 of each of Cycles 1 to 6 or 8|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.||Minutes||Inter-Quartile Range|Median
111780|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)||Cycle 2 through Cycle 6 or 8 (end of study)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.||Percentage of participants|||Number
111781|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1||Cycle 1|Intent-to-treat (ITT) population: All patients who received at least 1 dose of rituximab regardless of infusion rate.||Percentage of participants|||Number
111782|NCT00719472|Primary|Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2|The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate.|Days 1 and 2 of Cycle 2|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.||Percentage of participants||95% Confidence Interval|Number
111783|NCT00719355|Secondary|Onset of Claudication Pain During Constant Work Rate Treadmill Test|Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.|At 24 weeks|Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.||minutes||Standard Deviation|Mean
111784|NCT00719355|Primary|Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test|Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).|Baseline and 24 weeks|Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.||minutes||Standard Deviation|Mean
111785|NCT00719329|Primary|Colonization at Day 7 Swab|Were any organisms found on the swab collected on the day 07 visit?|First Week of Life|Intent to Treat||Participants|||Number
111786|NCT00719329|Primary|Colonization at Day 3 Swab|Were any organisms found on the swab collected on at Day 03|First Week of Life|Intent to Treat||Participants|||Number
111787|NCT00719329|Primary|Colonization at Day 1 Swab|Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism? If so, this is defined as positive.|First week of life|Intention to Treat||Participants|||Number
111788|NCT00719264|Secondary|Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab|This outcome measure was assessed continuously.|From the date of the first participant treated until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.||weeks||Full Range|Median
111789|NCT00719264|Secondary|Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
111790|NCT00719264|Secondary|Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units|The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
111791|NCT00719264|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths|Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.|From the first participant randomized until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.||Participants|||Number
111792|NCT00719264|Secondary|Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.|Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.|A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders.||Months||95% Confidence Interval|Median
111830|NCT00719043|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
111793|NCT00719264|Secondary|Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.||Number of participants|||Number
111794|NCT00719264|Secondary|Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.|Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
111795|NCT00719264|Primary|Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.||Months||95% Confidence Interval|Median
111796|NCT00719212|Secondary|Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat||months||95% Confidence Interval|Median
111797|NCT00719212|Secondary|Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression.|"The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:~Patients with elevated CA 125 pretreatment and normalization of CA 125 needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart or~Patients with elevated CA 125 pretreatment, which never normalizes needed to show evidence of CA 125 greater than, or equal to, two times the nadir value on two occasions at least 1 week apart or~Patients with CA 125 in the normal range pretreatment needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart."|Day 1 of each cycle|Intent To Treat||months||95% Confidence Interval|Median
111798|NCT00719212|Secondary|Overall Survival (OS) Investigator Assessment|Interval between the date of registration and the date of death|Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first|Intent To Treat||months||95% Confidence Interval|Median
111799|NCT00719212|Secondary|Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts|"RECIST(v1.0):~CR:disappearance of all target les°&non-target les°&normalization of tumor marker level~PR:at least 30% decrease in the sum of the LD of target les°-ref the baseline sum LD OR CR for target les°&incomplete resp/SD for non target les°~SD:insufficient shrinkage for PR or increase for PD-ref the smallest sum LD since ttmt started or Persistence of one/more non-target les°or/&maintenance of tumor marker level above the normal~CA125 level:~PR:elev of CA125 at baseline PR if a ≥ 50% decrease compared to baseline value observed on 2 consec assessmts drawn at least 1 wk apart~CR:elev of CA125 at baseline CR 2 CA125 below ULN observed on 2 consec assessmts drawn at least 1 wk apart~SD:neither CR/PR nor PD~Best overall resp of :~CR:if CR per RECIST & per CA125~PR:if CR per RECIST & PR per CA125 OR CR per RECIST and SD per CA125 with elev CA125 at baseline OR PR per RECIST & CR/PR or SD per CA125~SD:other cases not qualifying for progression-at least 24 wks"|At 16 weeks from registration|Intent To Treat||percentage of patients||95% Confidence Interval|Number
111831|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111800|NCT00719212|Primary|Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria.|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat||percentage of patients||95% Confidence Interval|Number
111801|NCT00719212|Secondary|Time To Progression (TTP) Investigator Assessment|Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat||months||95% Confidence Interval|Median
111802|NCT00719212|Primary|Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat||percentage of patients||95% Confidence Interval|Number
111803|NCT00719186|Secondary|Neonatal Complication Rate||September 2008 - December 2011||||||
111804|NCT00719186|Secondary|Number of Serious Adverse Events||as few as 5 months, up to 16 months|||events|||Number
111805|NCT00719186|Secondary|Number of Ovulations||as few as 5 months, up to 16 months|||ovulations|||Number
111806|NCT00719186|Secondary|Number of Pregnancy||as few as 5 months, up to 16 months|||participants|||Number
111807|NCT00719186|Primary|Live Birth|The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring.|as few as 5 months, up to 16 months|||participants|||Number
111808|NCT00719160|Secondary|Gastric pH|"The American Heritage Dictionary defines pH as a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14. The normal pH range for stomach acid is between 1.5 and 3.5."|Day 5 of a high protein diet|||units on a scale of pH||Standard Error|Mean
111809|NCT00719160|Primary|Percent Change in Intestinal Calcium Absorption|This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.|Day 5 of a high protein diet|||percentage of calcium absorption||Standard Error|Mean
111810|NCT00719134|Secondary|Pain Free at 2 Hours After Treatment|A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.|2 hours after treatment|For the secondary endpoint, the proportion of patients who were free from pain 2 hours after treatment, we used a mixed-effects logistic regression model to analyze the individual dichotomous outcomes.||percent of patients pain free||95% Confidence Interval|Number
111811|NCT00719134|Primary|Change in Headache Intensity|The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).|2 hours after treatment|For the primary endpoint, change in headache intensity from baseline to 2 hours after treatment, we used generalized linear mixed models with a normal random component and a logarithmic link function to analyze the pain scores.||percent change||95% Confidence Interval|Mean
111812|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111813|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|"A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0.~This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups."|At Days 10 and 42|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111814|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
111815|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Day 0, Day 10, Day 42, Day 182 and Day 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
111816|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 0, 10, 42, 182, 549 and 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
111817|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 10, 42, 182 and 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
111818|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
111819|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
111820|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Subjects|||Number
111905|NCT00718042|Primary|ESA Chagas Sensitivity|Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.|3 months|Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.||participants|||Number
111821|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
111822|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
111823|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.||Titers||95% Confidence Interval|Geometric Mean
111824|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111825|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111826|NCT00719043|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
111827|NCT00719043|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.|Within the 43-day (Days 0-42) post-vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
111828|NCT00719043|Primary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
111829|NCT00719043|Primary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
145078|NCT00427635|Secondary|Change From Baseline in Mean Bolus Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Seconds||Standard Deviation|Mean
111832|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111833|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
111834|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
111835|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111836|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111837|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111838|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Titers||95% Confidence Interval|Geometric Mean
111839|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111840|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Titers||95% Confidence Interval|Geometric Mean
149783|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Leiomyosaroma Group)||6 months|||months||95% Confidence Interval|Median
111841|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Titers||95% Confidence Interval|Geometric Mean
111842|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111843|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.||Subjects|||Number
111844|NCT00718887|Secondary|Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results|Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.|Day 1 through Week 48|"Participants who were randomized and received at least~1 dose of study drug."||Percentage of participants|||Number
111845|NCT00718887|Secondary|Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.|Continually from Day 1 through Week 48, and through 24-week follow-up period|"Participants who were randomized and received at least~1 dose of study drug."||Participants|||Number
111846|NCT00718887|Secondary|Number of Participants With Genotypic Resistance to Entecavir||At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."||Participants|||Number
111847|NCT00718887|Secondary|Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion||At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."||Participants|||Number
111848|NCT00718887|Secondary|Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion||At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and who were HBeAg-positive at baseline. n=number of evaluable participants.||Percentage of participants|||Number
111849|NCT00718887|Secondary|Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)|ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN|At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and whose ALT values were >1*ULN at baseline. n=number of evaluable participants.||Percentage of participants|||Number
111850|NCT00718887|Secondary|Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing|HBV=hepatitis B virus|At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."||log10 IU/mL||Standard Deviation|Mean
111851|NCT00718887|Secondary|Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing|HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."||Percentage of participants|||Number
111852|NCT00718887|Primary|Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing|HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 12 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."||Percentage of participants|||Number
111853|NCT00718861|Secondary|Change in Height at Years 7, 8 and 9 Relative to Year 6|Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with evaluable measurements at both Year 6 and the post-Year 6 visit, as determined by the analysis window.||millimeters (mm)||Standard Error|Least Squares Mean
111906|NCT00718042|Primary|ESA Chagas Specificity|Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.|3 months|Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.||participants|||Number
111855|NCT00718861|Secondary|Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6|Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.|Year 6 (extension 2 baseline), Year 9 (3 years of study duration)|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n= the number of patients with the event||participants|||Number
111856|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.||ng/ml||Full Range|Median
111857|NCT00718861|Secondary|Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.||ng/ml||Full Range|Median
111858|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.||ng/ml||Full Range|Median
111859|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
111860|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
111861|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
111862|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.||percentage change of BMD||Standard Error|Least Squares Mean
111863|NCT00718861|Primary|Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (baseline) and Year 9|The modified intent-to-treat (MITT) population included all patients in the ITT population who had DXA measurements of the total hip at Visit 11 (Year 6) and Visit 15 (Year 9). This was the primary population for the primary efficacy parameter.||Percentage Change of BMD||Standard Error|Least Squares Mean
117078|NCT00673075|Primary|Peripheral Diastolic Blood Pressure (DBP)|Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)|18 weeks post initiation of randomized treatment|||mmHg||Standard Error|Mean
111865|NCT00718809|Secondary|Disease Control Rate|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.|Up to 5 years|All patients who enrolled and received treatment||months||95% Confidence Interval|Median
111866|NCT00718809|Secondary|Overall Survival|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|Time from the date of registration to last reported date of survival, assessed up to 5 years|All patients who enrolled and received treatment||months||95% Confidence Interval|Median
111867|NCT00718809|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Time from the date of registration to the first reported outcome event, assessed up to 5 years|All patients who enrolled and received treatment.||months||95% Confidence Interval|Median
111868|NCT00718809|Primary|Objective Response Rate (Complete and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.|Up to 5 years|All patients with at least one post baseline measurement.||percentage of participants||95% Confidence Interval|Number
111869|NCT00718770|Primary|Change in Tumor Size|To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria|1 year|Adults with radioiodine resistant metastatic follicular cell derived thyroid cancer||cm||Standard Deviation|Mean
111870|NCT00718640|Secondary|Renal Function|Renal function was analysed by creatinine clearance. Creatinine clearance was calculated by Cockroft-Gault fourmula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter)|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111871|NCT00718640|Secondary|Quality of Life Assessed by Euro Quality of Life (EQ-5D)|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression where 1=better health state (no problems), 3=worst health state. Scoring formula was developed by Euro quality of life group which assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111872|NCT00718640|Secondary|Quality of Life Assessment by QLQ C-30|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale is equal to higher level of symptomatology or problems.|Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111873|NCT00718640|Secondary|Karnofsky Performance Status (KPS) Score|The KPS is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. KPS score is 11-level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111874|NCT00718640|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory (able to walk) and able to carry out work on a light or sedentary nature.|Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111875|NCT00718640|Secondary|Duration of Response|The duration of Response was defined as the time of first recorded achievement of a particular response level, which was defined according to IMWG uniform response criteria, as either complete response, stringent complete response, very good partial response or partial response included only responding participants, until the participants were assessed to have progressive disease.|Day 1 (Start of treatment) until the date of first documented achievement of response|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111876|NCT00718640|Secondary|Time to Progression (TTP) of Disease|The TTP was defined as the time from the date of starting treatment until the date of first documented evidence of progression of disease or death.|Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111930|NCT00717977|Primary|Nighttime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111877|NCT00718640|Secondary|Best Response to Treatment|It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or > reduction in serum and urine M-protein level<100 mg per 24 hour. Partial Response as <=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by <=90% or to <200mg per 24 hr.|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111878|NCT00718640|Primary|Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria|The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or >reduction in serum and urine M-protein level <100 milligram(mg) per 24 hour(hr).PR as <=50% reduction of serum and <= 90% of urine M-protein or up to <200 mg/24 hr.|Week 24 or Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.|||||
111879|NCT00718523|Secondary|Overall Survival (OS)|Interval between the date from randomization to death from any cause whichever came first.|Day 1 of each cycle up to 4 years after randomization|Unstratified Intent To Treat||months||95% Confidence Interval|Median
111880|NCT00718523|Secondary|Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle|Unstratified Intent To Treat||months||95% Confidence Interval|Median
111881|NCT00718523|Primary|Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle|Unstratified Intent To Treat||months||95% Confidence Interval|Median
111882|NCT00718315|Secondary|Percentage of Participants With Pain Stratified by Severity Grade|The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population||percentage of participants|||Number
111883|NCT00718315|Secondary|Percentage of Participants With Pruritus Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population||percentage of participants|||Number
111884|NCT00718315|Secondary|Percentage of Participants With Erythema Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population||percentage of participants|||Number
111885|NCT00718315|Secondary|Percentage of Participants With Pain|Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli|Days 0, 15, and 30|ITT Population||percentage of participants||95% Confidence Interval|Number
111886|NCT00718315|Secondary|Percentage of Participants With Pruritus|Pruritus is defined as intense localized itching|Days 0, 15, and 30|ITT Population||percentage of participants||95% Confidence Interval|Number
111887|NCT00718315|Secondary|Percentage of Participants With Erythema|Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries|Days 0, 15, and 30|ITT Population||percentage of participants||95% Confidence Interval|Number
111888|NCT00718315|Secondary|Time to Appearance of Skin Rash|Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE|Days 0, 15, and 30|ITT Population||Days||95% Confidence Interval|Median
111889|NCT00718315|Primary|Percentage of Participants With Skin Rash Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death|30 Days|ITT Population||percentage of participants|||Number
111890|NCT00718315|Primary|Percentage of Participants Who Develop Skin Rash|Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line “Rash/desquamation” – short name “rash”).|30 Days|ITT Population||percentage of participants||95% Confidence Interval|Number
112403|NCT00712335|Secondary|Sputum Eosinophil Percentages|Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups|24 weeks|We will use ITT and PP protocols for analysis||percentage of eosinophils||Standard Deviation|Mean
111891|NCT00718237|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool antigen prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).||Number of participants|||Number
111892|NCT00718237|Primary|Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).||Number of participants|||Number
111893|NCT00718237|Secondary|Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).||Number of participants|||Number
111894|NCT00718120|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
111895|NCT00718120|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
111896|NCT00718120|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
111897|NCT00718120|Primary|Fold Increase From Baseline in Serum HI Antibody Titer|The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.|At Day 21|||fold increase|||Number
111898|NCT00718120|Primary|Number of Seroprotected Subjects|Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.|At Day 0 and 21|||subjects|||Number
111899|NCT00718120|Primary|Number of Seroconverted Subjects|Seroconversion, defined as a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.|At Day 21|||subjects|||Number
111900|NCT00718120|Primary|Hemagglutination Inhibition (HI) Antibody Titers|Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.|At Day 0 and 21|||titer||95% Confidence Interval|Geometric Mean
111901|NCT00718081|Secondary|Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief|At the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.|Up to 12 hours after surgery|||percentage of patients|||Number
111902|NCT00718081|Primary|SPID-12|The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.|12 hours after surgery|||units on a scale||Standard Error|Least Squares Mean
111903|NCT00718042|Secondary|ESA Chagas Testing in Chagas Endemic Population|Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody. Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA). Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.|2 months|Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol.||participants|||Number
111904|NCT00718042|Secondary|ESA Chagas Sensitivity in Serologically Positive Non-US Specimens|ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded). These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.|3 months|A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol.||participants|||Number
149784|NCT00390234|Primary|Objective Response Rate, Evaluated According to the RECIST Criteria||Up to 3 years|||participants|||Number
111907|NCT00718042|Secondary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.|A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas. Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation). Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.|15 months|A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol.||participants|||Number
111908|NCT00718042|Secondary|PRISM Chagas Reactivity in Chagas Endemic Population|Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody. specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA). Data presented with PRISM Chagas and RIPA results.|2 months|Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol.||participants|||Number
111909|NCT00718042|Primary|PRISM Chagas Sensitivity|Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.|6 months|Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.||participants|||Number
111910|NCT00718042|Secondary|PRISM Chagas Reactivity Serology Positive Specimens|Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).|4 months|Total of 287 specimens presumed T cruzi antibody positive per protocol.||participants|||Number
111911|NCT00718042|Primary|PRISM Chagas Specificity|Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay [radioimmune precipitation assay (RIPA)].|6 months|All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.||participants|||Number
111912|NCT00717977|Primary|Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111913|NCT00717977|Primary|Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111914|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Time of Day|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||Percent||Inter-Quartile Range|Median
111915|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Age Group|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||Percent||Inter-Quartile Range|Median
111916|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Time of Day||48-72 hours|||mg/dL/min||Inter-Quartile Range|Median
111917|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Age Group||48-72 hours|||mg/dL/min||Inter-Quartile Range|Median
111918|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Time of Day|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111919|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Age Group|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours|||mg/dL||Inter-Quartile Range|Median
111920|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours."|48-72 hours|||Percent||Inter-Quartile Range|Median
111921|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
111922|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day||48-72 hours|||Percent||Inter-Quartile Range|Median
111923|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
111924|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours."|48-72 hours|||Percent||Inter-Quartile Range|Median
111925|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
111926|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day||48-72 hours|||Percent||Inter-Quartile Range|Median
111927|NCT00717977|Primary|Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group||48-72 hours|||Percent||Inter-Quartile Range|Median
111928|NCT00717977|Primary|Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day||48-72 hours|||Percent||Inter-Quartile Range|Median
111929|NCT00717977|Primary|Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group|The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.|48-72 hours|||Percent||Inter-Quartile Range|Median
111939|NCT00717860|Secondary|Number of Participants With Favorable Overall Response at the End of Study Therapy|Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|Per Protocol Set (PPS) population.||Participants|||Number
111940|NCT00717860|Secondary|Number of Participants With a Specific Safety Finding|A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|APaT population.||Participants|||Number
111941|NCT00717860|Primary|Number of Participants With a Significant Drug-related Adverse Experience|A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|All Participants as Treated (APaT) population.||Participants|||Number
111942|NCT00717756|Primary|Response Rate by Recist Criteria|"radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD~It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed."|on average about every 2 months until progression, on average about 4 months.|||participants|||Number
111943|NCT00717522|Secondary|Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines|Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).|This analysis was not done. Study enrollment was suspended due to a corporate strategic decision unrelated to patient safety, and the protocol was amended to evaluate safety only (efficacy data was stored but not cleaned or analyzed unless related to safety).|||||
111944|NCT00717522|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs|An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject’s health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.|AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).|All participants||participants|||Number
111945|NCT00717418|Other Pre-specified|Schirmer's Test With and Without Anesthesia at Baseline|Schirmer’s Test with and without anesthesia at baseline. The Schirmer’s test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit).||millimeters (mm)||Standard Deviation|Mean
111946|NCT00717418|Primary|Ocular Surface Disease Index (OSDI) Total Score at Baseline|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.||Scores on a Scale||Standard Deviation|Mean
111947|NCT00717405|Secondary|Overall Survival (OS) Duration|OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method.|Up to 5 years|ITT population.||months||95% Confidence Interval|Median
111948|NCT00717405|Secondary|Percentage of Participants Who Were Alive at 3 and 5 Years||3, 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
111949|NCT00717405|Secondary|Recurrence Free Survival (RFS) Duration|RFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.||months||95% Confidence Interval|Median
111950|NCT00717405|Secondary|Percentage of Participants Who Were Recurrence Free at 3 and 5 Years|A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes).|3, 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
111951|NCT00717405|Secondary|Disease Free Survival (DFS) Duration|DFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.||months||95% Confidence Interval|Median
118804|NCT00659789|Secondary|Time to Restart of ART for Vacc-4x Subjects Versus Placebo|Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)|Between Week 28 to Week 52|ITT Population||days||Standard Deviation|Mean
111952|NCT00717405|Secondary|Percentage of Participants Who Were Disease Free at 3 and 5 Years|A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause.|3, 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
111953|NCT00717405|Secondary|Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit||Baseline, Neoadjuvant Final Visit (Week 25)|Safety population: Number of participants included all the participants who received at least one infusion of bevacizumab. n included participants who were evaluable at that time point.||Units per milliliter (U/mL)||Standard Deviation|Mean
111954|NCT00717405|Secondary|Percentage of Participants Who Underwent Lymph Node Resection|Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.||percentage of participants|||Number
111955|NCT00717405|Secondary|Percentage of Participants With Macroscopically Visible Tumor|Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.||percentage of participants|||Number
111956|NCT00717405|Secondary|Number of Participants Who Underwent Mastectomy|Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment.|Anytime between Week 26 and Week 29|ITT population.||participants|||Number
111957|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed. n included number of participants who were evaluable at a particular time point.||percentage of participants|||Number
111958|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed and were evaluated for response from baseline assessment of inflammatory signs. n included number of participants who were evaluable at a particular time point.||percentage of participants|||Number
111959|NCT00717405|Secondary|Percentage of Participants With a PCR According to the Chevallier Classification|PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
111960|NCT00717405|Primary|Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification|PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.||percentage of participants||95% Confidence Interval|Number
111961|NCT00717314|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52|The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.|Week 52|PP population||percentage of participants|||Number
111962|NCT00717314|Secondary|Percentage Change in Creatinine Clearance From Baseline|Creatinine clearance was calculated using the Cockcroft and Gault formula.|Weeks 16, 28, 40, and 52|PP population||percentage change from baseline||Standard Deviation|Mean
111963|NCT00717314|Secondary|Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52|Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Week 52|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.||mL/min||95% Confidence Interval|Mean
112046|NCT00716963|Primary|The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Fall in FEV1.||Before inhalation 3 hours|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.||percentage fall FEV1||Standard Deviation|Mean
111964|NCT00717314|Secondary|Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])|Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Baseline and Weeks 16, 28, and 40|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
111965|NCT00717314|Secondary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52|BPAR was graded according to Banff criteria.|Week 52|PP population||percentage of participants|||Number
111966|NCT00717314|Secondary|Percentage of Participants With Graft Loss or Death at Week 52|Graft loss was defined for this protocol as re-transplantion or death.|Week 52|PP population||percentage of participants|||Number
111967|NCT00717314|Primary|Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%|The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.|Week 52|PP population||percentage of participants|||Number
111968|NCT00717288|Secondary|Reversion to Intravenous Insulin for Failure of Glycemic Control|Number of participants who went back on intravenous insulin for failure of glycemic control.|72 hours|||participants|||Number
111969|NCT00717288|Secondary|Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)|Number of patients with hypoglycemia (defined as glucose <65 mg/dl)|48 hours|Intention to treat (ITT)||participants|||Number
111970|NCT00717288|Primary|Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3|Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3|day 2, day 3|intention to treat (ITT)||participants|||Number
111971|NCT00717275|Primary|Number of Participants Who Developed Distant Brain Failure at One Year.||1 Year|Data was not analyzed.|||||
111972|NCT00717249|Primary|Average Contact Lens Wear Time|The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.|6 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||time in hours||Full Range|Mean
111973|NCT00717249|Primary|Visual Acuity|Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||LogMAR||Standard Deviation|Mean
111974|NCT00717249|Primary|Subject Reported Symptoms|"Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported."|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Percentage of Observations|Participants||Number
111975|NCT00717249|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.||Number of Subject Eyes|Participants||Number
111976|NCT00717236|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis||mm||Standard Error|Least Squares Mean
111977|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis||mm||Standard Error|Least Squares Mean
111978|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis||mm||Standard Error|Least Squares Mean
111979|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 28|Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis||mg/L||95% Confidence Interval|Least Squares Mean
111980|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis||units on a scale||Standard Error|Least Squares Mean
111981|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 28|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
111982|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 28|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
111983|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
111984|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
111985|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
111986|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
111987|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
111988|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.||units on a scale||Standard Error|Least Squares Mean
111989|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 28|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
111990|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 28|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
112178|NCT00715676|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|Percent change in lumbar spine BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent change||Standard Deviation|Mean
111991|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 28|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis||percentage of subjects|||Number
111992|NCT00717236|Secondary|European League Against Rheumatism (EULAR) Response at Week 12|EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
111993|NCT00717236|Secondary|Time to Sustained American College of Rheumatology 20% (ACR20) Response|The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).|Baseline up to Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
111994|NCT00717236|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mm||Standard Deviation|Mean
111995|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mm||Standard Deviation|Mean
111996|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mm||Standard Deviation|Mean
111997|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 12|Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||mg/L||Geometric Coefficient of Variation|Geometric Mean
111998|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
111999|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
112000|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
112001|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
112002|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
150385|NCT00385216|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
112003|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
112004|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis.||units on a scale||Standard Deviation|Mean
112005|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
112006|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
112007|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 12.|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
112008|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 12|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
112009|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis.||percentage of subjects|||Number
112010|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis.||percentage of subjects|||Number
112011|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis.||percentage of subjects|||Number
112070|NCT00716820|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112012|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis.||percentage of subjects|||Number
112013|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis.||percentage of subjects|||Number
112014|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis.||percentage of subjects|||Number
112015|NCT00717236|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis||percentage of subjects|||Number
112016|NCT00717197|Primary|Percentage of Participants With Progression-free Survival.|Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.|From date of first dose of study drug until month 6.|Per protocol||percentage of participants with PFS6||95% Confidence Interval|Number
112017|NCT00717093|Secondary|Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)|Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL.|Week 12, Week 26|ITT||participants|||Number
112018|NCT00717093|Secondary|Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco|Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26.|Week 26|ITT||participants|||Number
112019|NCT00717093|Secondary|Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use|Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL.|Week 9 through 12, Week 26|ITT||participants|||Number
112020|NCT00717093|Primary|Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco|"Number of subjects who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL."|Weeks 9 through 12|Intent to treat (ITT)||participants|||Number
112021|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals|Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to <480 msec, 480 to <500 msec, and >500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to < 60 msec, and change = ≥ 60 msec.|Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.||subjects|||Number
112022|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute|Number of subjects with pulse rate < 40 beats per minute (BPM), number of subjects with pulse rate > 120 BPM.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.||bpm|||Number
112071|NCT00716807|Primary|Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.||20 minute intervals for three hours.|Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.|||||
150386|NCT00385216|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|5 days|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
112023|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure|Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: <90 mmHg; and supine diastolic blood pressure, range: <50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication. BL: Baseline.||subjects|||Number
112024|NCT00717067|Secondary|Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD|CLdD: dialysate clearance before dialysis; measured in milliliters per minute.|Before dialysis|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||mL/min||Standard Deviation|Geometric Mean
112025|NCT00717067|Secondary|Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae|Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||mg||Standard Deviation|Mean
112026|NCT00717067|Secondary|Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function|Renal clearance (CLR) measured in milliliters per minute (mL/min).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||mL/min||Standard Deviation|Geometric Mean
112027|NCT00717067|Secondary|Half-life (t1/2)|Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||hour||Standard Deviation|Mean
112028|NCT00717067|Secondary|Time of First Occurrence (Tmax)|Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||hours||Full Range|Median
112029|NCT00717067|Secondary|Area Under the Time Curve From 0 to Infinity (AUCinf)|Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms * hour divided by millilters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.||ng*hr/mL||Standard Deviation|Geometric Mean
112030|NCT00717067|Secondary|Plasma Protein Binding|Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.|2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||percent free|||Number
112031|NCT00717067|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||ng/mL||Standard Deviation|Geometric Mean
112032|NCT00717067|Primary|AUCtau|AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms * hours divided by milliliters (ng.hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.||ng*hr/mL||Standard Deviation|Geometric Mean
112033|NCT00717067|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms * hour divided by milliliters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.||ng*hr/mL||Standard Deviation|Geometric Mean
112034|NCT00717054|Secondary|Need for Antiemetic Medication||24 hours postoperatively|||participants|||Number
112035|NCT00717054|Secondary|Total Vomiting||24 hours postoperatively|||participants|||Number
112036|NCT00717054|Secondary|Number of Participants With Nausea and Vomiting in PACU||Postoperatively, up to 2 hours|||participants|||Number
112037|NCT00717054|Primary|Number of Participants With Nausea and Vomiting||24 hours postoperatively|||participants|||Number
112038|NCT00717041|Secondary|Depression and Cognitive Impairment at 2 Weeks|For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.|2 weeks|||participants||95% Confidence Interval|Number
112039|NCT00717041|Primary|Participants With Anxiety by Generalized Anxiety Disorder - 7|Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.|2 hours|||participants|||Number
112040|NCT00717041|Primary|Participants With Cognitive Impairment by Six Item Screener|Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect|2 hours|||participants|||Number
112041|NCT00717041|Primary|Participants With Depression by Patient Health Questionnaire - 9|Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.|2 hours|||participants|||Number
112042|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||24 hours methacholine and sputum||||||
112047|NCT00716859|Secondary|Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience|An investigator’s causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as “related to investigational product” for reporting purposes.|Baseline through Week 12|Intent to treat (ITT) population: all participants who were randomized into the study and received at least 1 dose of study medication.||Percentage of particpants|||Number
112048|NCT00716859|Secondary|Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12|Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4, and Week 12|Evaluable participants in PP||Percentage of participants||95% Confidence Interval|Number
112049|NCT00716859|Secondary|Mean IOP at Week 12|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 12|Evaluable participants in PP||mmHg||Standard Deviation|Mean
112050|NCT00716859|Secondary|Mean IOP at Week 4|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 4|Evaluable participants in PP||mmHg||Standard Deviation|Mean
112051|NCT00716859|Secondary|Mean IOP at Week 1|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 1|PP||mmHg||Standard Deviation|Mean
112052|NCT00716859|Secondary|Mean IOP at Baseline|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline|PP||mmHg||Standard Deviation|Mean
112053|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 12 (Observed)|Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Evaluable participants in PP||mmHg||Standard Error|Least Squares Mean
112054|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 4|Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4|Evaluable participants in PP||mmHg||Standard Error|Least Squares Mean
112055|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 1|Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 1|PP||mmHg||Standard Error|Least Squares Mean
112056|NCT00716859|Primary|Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)|Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Per Protocol (PP) Population: participants with no major protocol violations who received at least 1 week of study medication and had at least Week 1 IOP measurements. LOCF.||mmHg||Standard Error|Least Squares Mean
112057|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112058|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
119573|NCT00651040|Secondary|Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures||1 year||12/2016||||
112059|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112060|NCT00716820|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112061|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112062|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112063|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112064|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112065|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112066|NCT00716820|Secondary|Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
112067|NCT00716820|Secondary|Objective Response Rates by c-Kit Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
112068|NCT00716820|Secondary|Objective Response Rates by KIT Expression Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
112069|NCT00716820|Primary|Objective Response Rate|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
112179|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 6|||days||Standard Deviation|Mean
112072|NCT00716742|Primary|Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year|Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).|Baseline, 1 Year|Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
112073|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112074|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112075|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112076|NCT00716625|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112077|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112078|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112079|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112080|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112081|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
150387|NCT00385216|Secondary|Heart Rate|Heart rate reported in beats per minute (BPM)|5 days|||Beats per minute (BPM)||Standard Deviation|Mean
112082|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Pediatric Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112083|NCT00716625|Primary|Objective Response Rate|Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.||Percentage of participants||95% Confidence Interval|Number
112084|NCT00716625|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.||Participants|||Number
112085|NCT00716482|Secondary|Interobserver Agreement of B Mode Ultrasound and SWE Features|614 benign and 144 malignant breast masses.|performed on the same day, after study completion|Per protocol. One lesion was analyzed per participant. Two independent readers did a qualitative assessment of 7 image parameters (per lesion) using Kappa.||kappa statistic||95% Confidence Interval|Number
112086|NCT00716482|Secondary|Intraobserver Reliability of Quantitative SWE Measurements|614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.|performed on the same day, within 2 years from study start date|Per protocol. 758 masses (614 benign and 144 malignant)are analyzed. One lesion was analyzed per participant. 3 acquisitions per lesion were analyzed with the ICC method for 10 different parameters.||correlation coefficient||95% Confidence Interval|Number
112087|NCT00716482|Secondary|Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature|614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.|performed on the same day, within 2 years from study start date|Per protocol. One lesion was analyzed per participant.||participants|||Number
112088|NCT00716482|Primary|Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics|"Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size.~Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions.~Based on 939 lesions."|2 years|Per protocol. Analysis includes 289 malignant and 650 benign masses. One lesion was analyzed per participant.||participants|||Number
112089|NCT00716456|Primary|The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks|To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)|At conclusion of study, up to 24 weeks|||mg/m2 of CETUXIMAB|||Number
112090|NCT00716443|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds|Number of participants w/ tolerability assessments (erythema, edema, blanching) resulting in adverse events from Baseline to two days after injection of Restylane® into the nasolabial folds|Baseline to two days after injection of Restylane® into the nasolabial folds|Safety||participants|||Number
112091|NCT00716443|Secondary|"Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds"|"Number of participants with yes or no answers to question asked to investigator on the day of injection of Restylane® into the nasolabial folds Did the topical anesthetics provided adequate anesthesia for the injections of Restylane® into the nasolabial folds procedure?"|Day of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112092|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112093|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after an injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112094|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
150388|NCT00385216|Secondary|hydrocodone5 mg/Acetaminopgen 325 mg Use||5 days||||||
112095|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112096|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112097|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112098|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112099|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|Upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112100|NCT00716443|Secondary|"Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds"|"Number of participants who answered No, Yes or No response to the question Still speaking to the topical anesthetic you had on the right/left side of your face, would you recommend it to your friend or family member? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112101|NCT00716443|Secondary|"Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered the question If it was different than what you expected, was it? (More pain, Less pain or No response) three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112102|NCT00716443|Secondary|"Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered No, Yes, Had no expectations or No response to the question If you experienced pain, was it what you expected from the injection procedure? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112103|NCT00716443|Secondary|"Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered according to a scale of None, Minimal, Mild, Moderate, Severe, or No response to the question What level of pain did you experience when you were injected? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
112104|NCT00716443|Primary|Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds|Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||centimeters||Standard Deviation|Mean
112105|NCT00716417|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of afatinib in plasma at steady state|0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration|The pharmacokinetic analysis set includes all patients who took at least one dose of trial medication and provided at least one blood sample following drug administration. Values were excluded from descriptive statistics when a comparison with plasma concentrations in the same treatment group was impossible.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
112176|NCT00715676|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52|Percent change in femoral neck BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent change||Standard Deviation|Mean
150389|NCT00385216|Secondary|Nausea||5 days||||||
112106|NCT00716417|Secondary|Number of Patients With Objective Response|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).|Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
112107|NCT00716417|Primary|Maximum Tolerated Dose (MTD) for Regimen A and Regimen B|The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||mg/m^2|||Number
112108|NCT00716417|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
112109|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for Plasma Glucose AUEC (0-3h).||mg*h/dL||Standard Error|Mean
112110|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for FPG.||mg/dL||Standard Error|Mean
112111|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for GLP-1.||pmol*h/L||Standard Error|Mean
112112|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for WMG.||mg/dL||Standard Error|Mean
112113|NCT00716092|Secondary|Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).|Baseline and day 28|The pharmacodynamic set (PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo, further restricted to patients who had a baseline and at least one on-treatment value for Glucose AUEC(0-3h). Sitagliptin results from model with all 3 groups.||mg*h/dL||Standard Error|Mean
112114|NCT00716092|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for FPG. Sitagliptin results are from model containing all 3 groups||mg/dL||Standard Error|Mean
112115|NCT00716092|Primary|GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups.||pmol*h/L||Standard Error|Mean
112116|NCT00716092|Primary|Weighted Mean Glucose (WMG) Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups||mg/dL||Standard Error|Mean
112117|NCT00716079|Secondary|Death at 90 Days||90 days|||participants|||Number
112118|NCT00716079|Primary|A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)||90 days|In the intensive group 12 patients were alive at 90 days but missing data on mRS (required for primary outcome), and 9 patients in the guideline group||participants|||Number
112119|NCT00715962|Primary|Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers|Throughout the hospital stay, both the WP and UC patient wore a triaxial accelerometer on the ipsilateral thigh and ankle. The patient’s skin was assessed regularly to assure there is no evidence of irritation. The wireless monitors were used to quantify the amount of mobility that occurs daily for each patient with researchers being blinded to the outcome.|During hospital stay|Only data from those recording days during which sensors were worn for at least 12 hours, defined as a valid day recording, were considered for final analysis. The average out of bed activity (standing or walking) duration over valid days of recording for each person was reported.||minutes/day||Standard Deviation|Mean
112120|NCT00715962|Secondary|Life-Space Assessment Score|"The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Life-space levels range from within one’s dwelling to beyond one’s town. A life-space composite score is calculated based on life-space level, degree of independence in achieving each level, and the frequency of attaining each level. Scores range from 0 - 120 with higher scores indicating greater community mobility."|4-6 weeks after baseline|||units on a scale||Standard Deviation|Mean
112121|NCT00715962|Primary|Falls|Patients were asked daily during hospitalization to self-report any falls|18 months|||participants|||Number
112122|NCT00715949|Secondary|To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.||study completion||||||
112123|NCT00715949|Primary|The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.|In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).|Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.|Analysis population includes only subjects who completed computerized neurocognitive tests. 120 subjects began the study, however 4 dropped out because they were unable to complete the first test and were not included in the final number of analyzed participants.||participants|||Number
112124|NCT00715910|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
112125|NCT00715910|Secondary|Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)|Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
112126|NCT00715910|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
112127|NCT00715910|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
112128|NCT00715910|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.||Subjects|||Number
112129|NCT00715910|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|"Vaccine response was defined as:~For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination."|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.||Subjects|||Number
112130|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.||Titers||95% Confidence Interval|Geometric Mean
112131|NCT00715910|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.||Subjects|||Number
112132|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 5 years following primary vaccination|Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.||Subjects|||Number
112133|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 3 years following primary vaccination|Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.||Subjects|||Number
112134|NCT00715910|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 1 year following primary vaccination|Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.||Subjects|||Number
112135|NCT00715910|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||μg/mL||95% Confidence Interval|Geometric Mean
112136|NCT00715910|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values|The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
112137|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Titers||95% Confidence Interval|Geometric Mean
112138|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Titers||95% Confidence Interval|Geometric Mean
112139|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Titers||95% Confidence Interval|Geometric Mean
112140|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
112141|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
112142|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
112143|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
112177|NCT00715676|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52|The percent change in hip BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was conducted on the Full Analysis Set, which included all randomized subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent Change||Standard Deviation|Mean
112144|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
112145|NCT00715910|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.||Subjects|||Number
112146|NCT00715884|Secondary|Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.|31-360 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure||Percentage of participants|||Number
112147|NCT00715884|Secondary|Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.|0-30 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure.||Percentage of participants|||Number
112148|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)|"Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following:~DEFINITE - Angiographic or pathologic confirmation;~PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent;~POSSIBLE - Any unexplained death > 30 days.~ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure||Percentage of participants|||Number
112149|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)|Protocol defined Stent thrombosis include both Early and Late Thrombosis. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure||Percentage of participants|||Number
112150|NCT00715884|Secondary|Percentage of Participants Who Experienced Stroke|The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
112151|NCT00715884|Secondary|Percentage of Participants Who Experienced Any Myocardial Infarction (MI)|Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
112152|NCT00715884|Secondary|Percentage of Participants Who Died|Death incidences include both Cardiac and non-cardiac death.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
112153|NCT00715884|Secondary|Percentage of Participants Who Experienced Bleeding Complications|Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and “Protocol” definitions.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events||Percentage of participants|||Number
112154|NCT00715884|Secondary|Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants who had diabetes and were followed up for 12 months.||Percentage of participants|||Number
112155|NCT00715884|Secondary|Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants with lesions of more than 1 vessel and were followed for 12 months||Percentage of participants|||Number
112156|NCT00715884|Secondary|Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)|MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
112157|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Failure (TVF)|Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
112158|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)|"TVR is defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
112159|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)|TLR is defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.|12 months post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
112160|NCT00715884|Secondary|Percentage of Participants Who Achieved Procedure Success|Procedure success is defined as achievement of a final diameter stenosis of < 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay.|At procedure during hospital stay|Intent to Treat||Percentage of participants|||Number
112161|NCT00715884|Secondary|Percentage of Device Success - All CYPHER® Stents Included|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. All CYPHER® Stents were included if the final residual stenosis was <50%. Non-study CYPHER® Stents were also included.|At procedure|Intent to Treat population.||Percentage of success|Participants||Number
112162|NCT00715884|Secondary|Percentage of Device Success - Protocol Definition|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. Protocol definition: Only protocol-defined study stents were included.|At procedure|Intent to Treat population.||Percentage of success|Participants||Number
112163|NCT00715884|Secondary|Percentage of Lesion Success|Lesion success is defined as the attainment of < 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.|At procedure|ITT: All randomized participants regardless whether they received the intervention||Percentage of success|Participants||Number
112164|NCT00715884|Primary|Percentage of Participants Who Experienced Target Lesion Failure (TLF)|The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12-months post-procedure|Event-specific adjusted intent to treat (ITT) population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure||Percentage of participants|||Number
112165|NCT00715754|Primary|Estimated Fetal Weight Percentile|Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation|||Percentile||Standard Deviation|Mean
112166|NCT00715754|Primary|Fetal Abdominal Circumference|Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation|||cm||Standard Deviation|Mean
112167|NCT00715754|Primary|Infant Adiposity at 24-72 Hours Following Birth|Adiposity as measured by air displacement plethysmography|24-72 hours following birth|||Percentage of total body weight||Full Range|Mean
112168|NCT00715741|Secondary|SpO2 Postoperatively|SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.|24 hours after tracheal extubation|||percent saturation||Standard Deviation|Mean
112169|NCT00715741|Secondary|"Arterial Oxygen Saturation by Pulse Oximetry (SpO2)"|SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%|45 min after tracheal extubation|||percent saturation||Standard Deviation|Mean
112170|NCT00715741|Primary|Oxygen Requirement|amount of oxygen (LPM) required to maintain SpO2 >90%|24 hours after tracheal extubation|||liters per min||Inter-Quartile Range|Median
112171|NCT00715741|Primary|Oxygen Requirement to Maintain SpO2>90%|Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.|45 min after emergence (tracheal extubation)|||liters per minute||Inter-Quartile Range|Median
112172|NCT00715676|Secondary|Number of Subjects With at Least 1 Treatment-emergent Adverse Event|To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.|1 year|The participants for this analysis included all randomized subjects who received a dose of study drug.||Participants|||Number
112173|NCT00715676|Secondary|Percent Change From Baseline in Serum Bone Markers at Week 26|Percent change from baseline at Week 26|Baseline and Week 26|Analyses were performed using subjects for whom both Baseline and Week 26 samples were available.||Percent change||Standard Deviation|Mean
112174|NCT00715676|Secondary|Change From Baseline in Serum Calcium Levels at Week 52|Change in serum calcium value (relative to baseline) at Week 52|Baseline and Week 52|This analysis was done for all subjects for whom both baseline and Week 52 data was available.||mg/dL||Standard Deviation|Mean
112175|NCT00715676|Secondary|Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52|Percent change in trochanter BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.||Percent change||Standard Deviation|Mean
112180|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 3|||days||Standard Deviation|Mean
112183|NCT00715624|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration for up to 125 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
112184|NCT00715624|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
112185|NCT00715624|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112186|NCT00715624|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
112187|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
112188|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
112189|NCT00715624|Secondary|Change From Baseline in Total Insulin Dose at Week 24|Change was calculated for total insulin dose by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline total insulin dose assessment during on-treatment period.||units per day||Standard Error|Least Squares Mean
112190|NCT00715624|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
112191|NCT00715624|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112192|NCT00715624|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 7-point SMPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112193|NCT00715624|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112194|NCT00715624|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. LOCF was used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
112195|NCT00715559|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|"The SAFTEE is used to measure somatic and other symptoms which may arise during the course of a clinical trial. This is a non-quantitative instrument that does not yield a numeric score. Instead, it provides study subjects the opportunity to check off symptoms listed on a checklist and indicate if the severity of the symptoms is mild moderate or severe. The reported values represent symptoms that were indicated at any point during the 8 week trial at a level of moderate or severe that also represented a change from a baseline-line pre-intervention SAFTEE assessment."|weekly, for 8 weeks|Study participants were assessed for side effects or adverse events with the SAFTEE at each study visit over the 8 week trial.||symptoms||Standard Deviation|Mean
112196|NCT00715559|Secondary|Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)|This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).|8 weeks|||scale score||Standard Deviation|Mean
112197|NCT00715559|Secondary|Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)|"This set of scales measures global improvement in a patient's level of symptoms, without reference to a particular condition (ie depression). GCI-S is a measure of severity, which ranges from 0 (not ill) to 7 (severely ill). CGI-I is a measure of change, with a score of 4 indicating no change, 1 indicating very much improved and 7 indicating very much worse."|8 weeks|||scale score||Standard Deviation|Mean
112198|NCT00715559|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.|8 weeks|Mean MADRS score at end of treatment (LOCF) in 3 participants treated with cysteamine bitartrate.||scale score||Standard Deviation|Mean
112199|NCT00715403|Primary|Difference From Baseline for Electrolytes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||mmol/L||Standard Error|Median
112200|NCT00715403|Primary|Difference From Baseline for Coagulation Parameters|Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||sec||Standard Error|Median
112201|NCT00715403|Primary|Difference From Baseline for Haematology and Differentials Parameters|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||10^9 /L||Standard Error|Median
112202|NCT00715403|Primary|Difference From Baseline for Haemoglobin|Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From baseline until end of treatment, up to 991 days|Treated set.||g/dL||Standard Error|Median
112203|NCT00715403|Primary|Difference From Baseline for Bilirubin, Creatinine and Glucose|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||mg/dL||Standard Error|Median
112204|NCT00715403|Primary|Difference From Baseline for Liver Enzymes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.||U/L||Standard Error|Median
112205|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5|All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
112206|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4|All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
112207|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3|All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
112208|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2|All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
112209|NCT00715403|Secondary|Progression Free Survival|"Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.~PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.~Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first."|First drug administration (in previous trial) until end of treatment, up to 1230 days|Treated set. Data for category||percentage of participants|||Number
112210|NCT00715403|Secondary|Confirmed Objective Response|Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
112211|NCT00715403|Secondary|Clinical Benefit|Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
112212|NCT00715403|Secondary|Unconfirmed Best Objective Response|Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
112213|NCT00715403|Secondary|Unconfirmed Best Overall Response|"Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).~PD = Progressive disease."|Baseline until end of treatment, up to 991 days|Treated set.||percentage of participants|||Number
112214|NCT00715403|Secondary|Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)|Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29|Just before drug administration every 28±7 days after day 29|Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
112215|NCT00715403|Secondary|Clinically Relevant Abnormalities for Vital Signs|Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From baseline until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
112216|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1|All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set||percentage of participants|||Number
112217|NCT00715390|Primary|Arrhythmias During General Anesthesia in Children||July 1998 through July 2004|||participants|||Number
112218|NCT00715299|Primary|The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.|Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.|Pre and post Treatment|||meters per second||Standard Deviation|Mean
112219|NCT00715208|Secondary|Number of Patients Who Experienced at Least One Serious Adverse Event||From completion of informed consent through 30 days after the last dose of study drug|Safety Population: Treated patients||participants|||Number
112220|NCT00715208|Secondary|Duration of Response|"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.~CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria."|2 years|Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders)||Months||95% Confidence Interval|Median
112221|NCT00715208|Secondary|Percentage of Participants With Progression-free Survival (PFS) at 1 Year|PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).|Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD|Safety population: Treated||percentage of participants|||Number
112640|NCT00711009|Secondary|Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112222|NCT00715208|Secondary|Number of Participants With Overall Response (OR)|"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.~CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET."|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death.||participants|||Number
112223|NCT00715208|Primary|Number of Patients With Complete Response (CR)|Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death.||participants|||Number
112224|NCT00715117|Primary|Number of Patients Reporting Side Effects|Using adverse events and laboratory values Safety & toxicity were evaluated between those on placebo for 8 weeks and those on naltrexone for either 8 or 16 weeks.|8 weeks or 16 weeks|The Fisher Exact Test was used to evaluate the number of side effects reported between placebo and naltrexone groups. The Student T-test was used to evaluate the differences between the mena values of laboratory tests.||participants|||Number
112225|NCT00715117|Secondary|Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy|IMPACT III was a pediatric Crohn's specific quality of life survey used in this study. It examines five major categories influencing the quality of life in children with Crohn’s disease including bowel symptoms, systemic symptoms, emotional well-being, social well-being, and body image perception. The IMPACT-III uses 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. So an increase in score denotes improved Quality of life.|16 weeks|||units on a scale||Standard Error|Mean
112226|NCT00715117|Secondary|Pediatric Crohn's Disease Activity Index Score (PCDAI)|"Secondary outcome was efficacy on clinical activity. Mean pretreatment PCDAI scores in patients had moderate to severe disease activity at baseline were compared between those who received placebo for 8 weeks and those who received active experimental drug, naltrexone.~The PCDAI score is a number unit that is calculated from symptoms scores by the subject over a 7-day period prior to the visit, laboratory values, height & weight, and physical exam findings. A score of 10 and under denotes remission. Mild disease (score of 11-30); moderate disease (score of 31-45), a severe disease (scores greater than 45. A decline of 10 points or more is considered response to therapy. The score can range from 0 to >60 Patient must have a PCDAI score of equal or greater than 30 to qualify for this study (i.e., moderate to severe disease)."|Pretreatment and 8 weeks|The power calculations were performed using STPLAN version 4.1. The current investigation was designed as a pseudo-cross over study to increase the number of participants. In the proposed study, it was assumed that 80% would respond to naltrexone and that no more than 25% of the placebo.||units on a scale||Standard Error|Mean
112227|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.||numbers of spots||Standard Error|Mean
112228|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.||number of spots||Standard Error|Mean
112229|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.|The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.||number of spots||Standard Error|Mean
112230|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.|The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.||numbers of spots||Standard Error|Mean
112231|NCT00715104|Secondary|Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood|Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.|Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."||numbers of spots||Standard Error|Mean
112232|NCT00715104|Secondary|Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood|"Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays.~This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150–7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells."|Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."||numbers of spots||Standard Error|Mean
112641|NCT00711009|Secondary|Mean Change From Baseline in Uric Acid (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112233|NCT00715104|Secondary|Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"||cells/μm2||Standard Error|Mean
112234|NCT00715104|Secondary|Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"||cells/μm2||Standard Error|Mean
112235|NCT00715104|Primary|Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."||cells/μm2||Standard Error|Mean
112236|NCT00715078|Secondary|Evaluate the Overall Survival in Each of the Cohorts.||Overall survival will be evaluated after the last living subject has completed the Month 36 visit.||||||
112237|NCT00715078|Secondary|Evaluate the Magnitude of the Immune Response in Each of the Cohorts.||Overall survival will be evaluated after the last living subject has completed the Month 36 visit.||||||
112238|NCT00715078|Primary|Compare the Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Baseline and up to week 36|Subjects received exactly 3 infusions||ln([final product/BDS65] of CD54+)||Standard Deviation|Mean
112239|NCT00715026|Secondary|Continued Assessment of Implant Survivorship and Incidences of Adverse Events.|A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.|At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years|||adverse events|||Number
112240|NCT00715026|Primary|Harris Hip Score|The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.|Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years|Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market.||units on a scale||Standard Deviation|Mean
112241|NCT00714948|Primary|To Determine the Progression Free Survival Rate at One Year Untreated Patients With Advanced/Metastatic Urothelial Carcinoma Treated With the Combination of Sorafenib, Gemcitabine, and Cisplatin.||conclusion of the study||||||
112242|NCT00714870|Primary|Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)|"Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).~Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.~Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30."|one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later|To detect an effect with greater than or equal to 80% power at a 0.05 two sided significant level, we concluded we needed 22 participants completing each group, intervention and control||units on a scale||Standard Deviation|Mean
112243|NCT00714714|Primary|Assessment of Facial Irritation and Cutaneous Effects|Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)|cumulative daily weekday scores for two weeks|One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).||Ordinal data treated as interval||Standard Deviation|Mean
112244|NCT00714688|Secondary|Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score|The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. It excludes patients for which a baseline value was missing.||units on a scale||Standard Deviation|Mean
112245|NCT00714688|Secondary|Clinical Global Impression-Change (CGI-C)|The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.It excludes patients for which either a baseline or end of treatment value was missing.||units on a scale||Full Range|Median
112246|NCT00714688|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment|The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.||units on a scale||Full Range|Median
112247|NCT00714688|Primary|Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)|The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.||units on a scale||Standard Deviation|Mean
112248|NCT00714571|Primary|Memory Test Accuracy on Trained Stimuli|Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test|Pre-training, post-training, 1 month|MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study||Percent correct||Standard Deviation|Mean
112249|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Weeks 26.|Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 26|||percentage|||Number
112250|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Week 10|Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 10|||percentage|||Number
112251|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 26|||scale -3 to 3||Standard Deviation|Mean
112252|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 10|||scale -3 to 3||Standard Deviation|Mean
112253|NCT00714493|Secondary|Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26|Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26|Week 26|||percentage|||Number
112254|NCT00714493|Secondary|Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase|Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase|Week 26|||percentage|||Number
112255|NCT00714493|Primary|Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10|Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.|Week 10|The evaluable population was the subset of the mITT population (included the enrolled patients who received at least 1 dose of study medication) after excluding all 6 patients from Site 8631 where significant trial misconducts were identified.||Percentage|||Number
112256|NCT00714389|Primary|Maximal Flow Rate|Maximal uroflow of spontaneous subject voids|March 2008|||mL/sec||Standard Deviation|Mean
112257|NCT00714389|Primary|Voided Volume|Volume of spontaneous void|March 2008|||mL||Standard Deviation|Mean
112258|NCT00714311|Secondary|Borderline Symptomatology (DSM-IV Criteria)||1 month||||||
112259|NCT00714311|Secondary|Attachment Style and Reflective Function (Adult Attachment Interview, AAI)||1 year||||||
112260|NCT00714311|Secondary|Self-assessment of Psychopathology (BDI, STAI, BSI)||1 year||||||
112261|NCT00714311|Secondary|Number of Self-harming Acts||1 year||||||
112262|NCT00714311|Secondary|Level of Personality Organization (Structured Interview for Personality Organization, STIPO)||1 year||||||
112263|NCT00714311|Secondary|Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)||1 year||||||
112264|NCT00714311|Primary|Suicidality (Suicide Attempts)||1 year||||||
112265|NCT00714311|Primary|Drop-out|Did not finish one year of treatment.|1 year|||participants|||Number
122113|NCT00623779|Primary|Premature Discontinuation of Study Drug Due to Any Reason|The premature discontinuation of study drug due to any reason|24 weeks (randomisation visit to last treatment visit)|||Participants|||Number
112266|NCT00714285|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
112267|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination|During a 21 day (Days 0-20) follow-up period after vaccination-|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
112268|NCT00714285|Secondary|Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).|MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.||Subjects|||Number
112269|NCT00714285|Secondary|Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.|Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed||Subjects|||Number
112270|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed||Subjects|||Number
112271|NCT00714285|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.|Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.||Subjects|||Number
112272|NCT00714285|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During a 7 day (Days 0-6) follow-up period after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.||Subjects|||Number
112273|NCT00714285|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Days 0 and 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
112274|NCT00714285|Secondary|HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
112275|NCT00714285|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
112276|NCT00714285|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
112277|NCT00714233|Secondary|Change in Fasting Glucose|Change in fasting glucose concentration by treatment group pre to post intervention|baseline and 24 weeks|||mg/dL||Standard Deviation|Mean
112278|NCT00714233|Secondary|Triglyceride Concentration by Treatment Group|Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo|baseline and 24 weeks|||mg/dL||Standard Deviation|Mean
112279|NCT00714233|Secondary|Change in SHBG|Measurement of SHBG by treatment group pre and post intervention|baseline and 24 weeks|||ratio||Standard Deviation|Mean
112280|NCT00714233|Secondary|Change in Free Androgen Index (FAI)|Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.|baseline and 24 weeks|analysis per protocol||total T/SHBG||Standard Deviation|Mean
112281|NCT00714233|Secondary|Weight Loss in Lifestyle Intervention Group|In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI|baseline and 24 weeks|Analysis per protocol||kg/m^2||Standard Deviation|Mean
112282|NCT00714233|Primary|Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification|The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY|24 week|Analysis was a description of number of recruited subjects.||participants|||Number
112283|NCT00714168|Secondary|Body Composition|Change in Percent Body Fat from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis||percent body fat||95% Confidence Interval|Least Squares Mean
112284|NCT00714168|Secondary|Cardiovascular Fitness|Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.||minutes||95% Confidence Interval|Least Squares Mean
112285|NCT00714168|Secondary|Energy Intake|Change in Energy Intake from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects analyzed.||kcal/day||95% Confidence Interval|Least Squares Mean
112286|NCT00714168|Secondary|Physical Activity|Change in Physical Activity from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.||kcal/week||95% Confidence Interval|Least Squares Mean
112287|NCT00714168|Primary|Weight Loss|Change in Weight from Baseline|Measured at Month 18|We used an intention-to-treat analysis with all randomized subjects included in the analysis.||kg||95% Confidence Interval|Least Squares Mean
112288|NCT00714051|Primary|Number of Participants Who Fell on a Tripping Test|Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.|4 weeks|||participants|||Number
112289|NCT00713830|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 120 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The one patient in the placebo group who received Lixisenatide was analyzed in the Lixisenatide group||participants|||Number
112290|NCT00713830|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
112291|NCT00713830|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
112642|NCT00711009|Secondary|Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112292|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
112293|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
112294|NCT00713830|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|The fasting C-peptide and the 2-hour postprandial C-peptide blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. here. number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||nmol/L||Standard Error|Least Squares Mean
112295|NCT00713830|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|The fasting proinsulin-to-insulin ratio and 2-hour postprandial proinsulin-to-insulin ratio were measured during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data imputed using LOCF. Number of patients analyzed=patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n'= patients with baseline and at least 1 post-baseline assessment for the specific category.||ratio||Standard Error|Least Squares Mean
112296|NCT00713830|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|The fasting Proinsulin and the 2-hour postprandial Proinsulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
112297|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin at Week 24|The fasting plasma insulin and the 2-hour postprandial plasma insulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||pmol/L||Standard Error|Least Squares Mean
112298|NCT00713830|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|The fasting glucagon and the 2-hour postprandial glucagon blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.||ng/L||Standard Error|Least Squares Mean
112328|NCT00713479|Primary|Heart Rate|Heart rate is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|||bpm|Participants|Standard Deviation|Mean
112643|NCT00711009|Secondary|Mean Change From Baseline in Creatinine (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112299|NCT00713830|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112300|NCT00713830|Secondary|Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta blood samples were drawn during a standardized meal challenge test (performed in selected sites). HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||% of normal beta cells function||Standard Error|Least Squares Mean
112301|NCT00713830|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
112302|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112303|NCT00713830|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG blood sample was drawn 2 hours after start of a standardized meal (standardized meal challenge test performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112304|NCT00713830|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-Treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
112305|NCT00713817|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study is presented.|Day 0 -35|The safety analysis set comprised all subjects who received at least one dose of study medication.||participants|||Number
112306|NCT00713817|Secondary|Subject Global Impression of Change at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your nerve pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects wo reported an improvement is presented.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
112307|NCT00713817|Secondary|Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112308|NCT00713817|Secondary|Number of Subjects With More Than a 20% Loss of Response at the End of Treatment|The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
112309|NCT00713817|Secondary|Number of Subjects Who Failed Treatment at the End of the Treatment Period|"Treatment failure was defined as follows:~A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr:~B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline."|Day 7 to time of last dose|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
112310|NCT00713817|Secondary|Change From Baseline Neuropathic Pain Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112311|NCT00713817|Primary|Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112312|NCT00713700|Primary|The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.|The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.|180 days|Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended.||percentage of participants||95% Confidence Interval|Number
112313|NCT00713700|Primary|The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.|"The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure~SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event."|180 days|Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up.||percentage of participants||95% Confidence Interval|Number
112314|NCT00713661|Secondary|The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.|Day of surgery|Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set.||participants|||Number
112315|NCT00713661|Primary|The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.|Day of surgery|"ITT + Safety Analysis Set.~All applications recorded as “not feasible” by external assessor was because he was not able to see it all the way around the anastomosis. The implication is that the primary endpoint was not really reporting the true feasibility, as it was hindered due to technical/practical problems recording the whole anastomosis."||participants|||Number
112316|NCT00713648|Secondary|Number of Subjects With rFXIII Antibody Development|Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - Subjects who received at least one dose of trial product.||participants|||Number
112329|NCT00713479|Primary|Diastolic Blood Pressure|Diastolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|||mm Hg|Participants|Standard Deviation|Mean
112330|NCT00713479|Primary|Systolic Blood Pressure|Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|Per protocol||mm Hg|Participants|Standard Deviation|Mean
112331|NCT00713349|Primary|Complete Wound Closure|Each subject acting as their own control|21 Days|||days||Standard Deviation|Mean
112317|NCT00713648|Secondary|Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.||U/kg||Standard Deviation|Mean
112318|NCT00713648|Secondary|Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.||percentage (%) of subjects|||Number
112319|NCT00713648|Primary|Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period|It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product.||bleeding episodes per subject per year||Full Range|Mean
112320|NCT00713596|Primary|Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity|"ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied).~NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem).~Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose"|6 months post operative||||||
112321|NCT00713596|Secondary|Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire|At the end of the study standard post operative rhinoplasty photos will be obtained, and the photos will be reviewed by three blinded observers, who are experienced rhinoplasty surgeons. The photos will be presented to the evaluators in a completely random fashion at a single session. These photos will be graded at that time using the same questionnaire used by the operating surgeon. The questionnaire covers bruising, swelling, tenderness, and length, width, hump and tip of nose, with a range 4-40, 4=ideal nose to 40=many postoperative problems and disfigured nose.|6 months postoperative||||||
112322|NCT00713544|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 12 Weeks minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability.|Baseline to 12 Weeks|||Units on a scale||Standard Deviation|Mean
112323|NCT00713544|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28)|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 12 Weeks’ treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms.|Baseline to 12 Weeks|||Units on a scale||Standard Deviation|Mean
112324|NCT00713544|Secondary|American College of Rheumatology 70 Response (ACR70)|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks|||Participants|||Number
112325|NCT00713544|Secondary|American College of Rheumatology 50 Response (ACR50)|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks|||Participants|||Number
112326|NCT00713544|Primary|American College of Rheumatology 20 Response (ACR20)|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks|||Participants|||Number
112327|NCT00713479|Secondary|Depression|Using the Beck Depression Index (BDI-II), depression was assessed on a daily basis. The daily mean score during the medication intervention period is presented, with a lower score indicating lower reported depression. The scores range from 0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression.|Daily|||units on a scale|Participants|Standard Deviation|Mean
112389|NCT00712530|Secondary|Number of Subjects Having More Than 50 Copies/mL HIV RNA||28 days|||participants|||Number
112332|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)|"The patient was asked on a scale of ‘0 to 10’ please indicate the average level of your intoxication due to medications over the last 24 hours (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
112333|NCT00713323|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).|42 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||participants|||Number
112334|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
112335|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
112336|NCT00713323|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|week 38|All subjects who received at least one dose of open-label Sativex were included in the analysis.||participants|||Number
112337|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
112338|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
112339|NCT00713323|Primary|Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.||units on a scale||Standard Deviation|Mean
112340|NCT00713310|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and Week 6|mITT subjects who were randomized & took at least one dose of study medication||% participants with treatment success|||Number
112341|NCT00713310|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and 6 weeks|miTT includes subjects who were randomized and took at least one dose of study medication||% participants with treatment success|||Number
112342|NCT00713258|Secondary|Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment|"Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person’s functional level is restricted by pain.~ODI scores from 0 = no disability to 100 = maximum disability.~Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status."|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."||scores on a scale||Standard Deviation|Mean
112343|NCT00713258|Primary|Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.|The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = “no pain” and 10 = “unendurable pain”).|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."||points on a scale||Standard Deviation|Mean
112344|NCT00713219|Primary|Overall Progression-Free Survival (PFS).|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|conclusion of the study|||Days||Full Range|Mean
112345|NCT00713206|Secondary|Crestal Bone Regression||four years||||||
112346|NCT00713206|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis|3 year|Number of participants used in analysis selected as per protocol||participants|Participants||Number
112347|NCT00712985|Primary|Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months|17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.|One year|||participants|||Number
112348|NCT00712959|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose|"Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
112349|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
112350|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
112351|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:~≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or~≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or~≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ."|Day 30 post-vaccination|Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.||Percentage of Particpants|||Number
112352|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Anti-diphtheria or anti-tetanus booster responses were defined as:~Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response."|Day 30 post-vaccination|Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.||Percentage of Participants|||Number
112353|NCT00712959|Primary|Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
112354|NCT00712959|Primary|Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose|"Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).~Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL."|Day 0 (pre-vaccination) and 30 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.||Percentage of Participants|||Number
112355|NCT00712920|Secondary|Change From Baseline on Direct Visual Nasal Exams and 28 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 28 days|ITT||Participants|||Number
112356|NCT00712920|Secondary|Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days|A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.|baseline and 28 Days|ITT||Units on a Scale||Standard Deviation|Least Squares Mean
112390|NCT00712530|Secondary|Number of Subjects With Detectable Anti-ds Antibody and ANA||28 days|||participants|||Number
112391|NCT00712530|Secondary|CD4+ T Cell Counts/mm3||28 days|||CD4+ T cell counts/mm3||Standard Deviation|Mean
112357|NCT00712920|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days|Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.|baseline and 28 days|ITT||Scores on a Scale||Standard Deviation|Least Squares Mean
112358|NCT00712920|Secondary|Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day."|baseline and 28 days|ITT||Scores on a Scale||Standard Deviation|Least Squares Mean
112359|NCT00712920|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.|"Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day~Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 28 days|ITT||Scores on a Scale|||Number
112360|NCT00712725|Secondary|Sustained Pain Freedom (SPF)|Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.|2-24 hours postdose|Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.||Participants|||Number
112361|NCT00712725|Secondary|Absence of Nausea|Absence of nausea at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
112362|NCT00712725|Secondary|Absence of Phonophobia|Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
112363|NCT00712725|Secondary|Absence of Photophobia|Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
112364|NCT00712725|Secondary|Pain Relief (PR)|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
112365|NCT00712725|Primary|Pain Freedom (PF)|"Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.||Participants|||Number
112366|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
112367|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
112368|NCT00712673|Secondary|Percentage of Patients Requiring Rescue Therapy During the Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
112392|NCT00712530|Primary|Grade 3 Adverse Event Related to DermaVir Treatment|Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.|28 days|||participants|||Number
112393|NCT00712348|Primary|Hemoglobin||Every 3 months from Baseline to Month 9|||g/dL||Standard Deviation|Mean
112394|NCT00712348|Other Pre-specified|Liver Volume|Liver volume measured by MRI|Baseline and 9 months|2 patients were MRI phobic||mL||Standard Deviation|Mean
112369|NCT00712673|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
112370|NCT00712673|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
112371|NCT00712673|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.||% of normal beta cells function||Standard Error|Least Squares Mean
112372|NCT00712673|Secondary|Change From Baseline in Adiponectin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline adiponectin assessment during on-treatment period.||mcg/mL||Standard Error|Least Squares Mean
112373|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.||ng/L||Standard Error|Least Squares Mean
112374|NCT00712673|Secondary|Change From Baseline in Fasting Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.||ng/L||Standard Error|Least Squares Mean
112375|NCT00712673|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal teat. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112376|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.||nmol/L||Standard Error|Least Squares Mean
112377|NCT00712673|Secondary|Change From Baseline in Fasting C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.||nmol/L||Standard Error|Least Squares Mean
112378|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
112379|NCT00712673|Secondary|Change From Baseline in Fasting Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
112380|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PPI assessment during on-treatment period||pmol/L||Standard Error|Least Squares Mean
112381|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period.||pmol/L||Standard Error|Least Squares Mean
112382|NCT00712673|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
112383|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112384|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
112385|NCT00712673|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
112386|NCT00712543|Primary|Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.||14 days|||participants|||Number
112387|NCT00712530|Other Pre-specified|Change in HIV-specific Memory T Cell Responses at Week 48|"HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.~Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available"|48 weeks|||PHPC count||Standard Deviation|Mean
112388|NCT00712530|Secondary|Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline|HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.|28 days|||PHPC count||Standard Deviation|Mean
112404|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.||Percentage of participants|||Number
112405|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.||Percentage of participants|||Number
112406|NCT00712244|Secondary|Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during anterior capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.||Percentage of participants|||Number
112407|NCT00712244|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure is between 10 mmHg and 20 mmHg.|1 day after surgery|This data was collected on all subjects attending the visit one day after surgery with the exception of 3 DisCoVisc subjects, 4 DuoVisc subjects, 2 Healon5 subjects, and 1 AmVisc Plus subject.||mmHg||Standard Deviation|Mean
112408|NCT00712244|Secondary|Aqueous Signs - Aqueous Cells|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings: 0 - None, 1 - 1 to 5 cells, 2 - 6 to 15 cells, 3 - 16 - 30 cells, 4 - >30 cells.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.||Percentage of participants|||Number
112409|NCT00712244|Secondary|Aqueous Signs - Aqueous Flare|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings: 0 - None: No visible flare when compared to the normal eye, 1 - Mild: Flare visible against dark papillary background but not visible against iris background, 2 - Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as teh dark papillary background, 3 - Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.|1 Day after Surgery|This data was collected for all subjects attending the visit one day after surgery.||Percentage of participants|||Number
112410|NCT00712244|Secondary|Aqueous Signs - Corneal Edema|Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings: 0 - none; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.||Percentage of Participants|||Number
112411|NCT00712244|Secondary|Percent Gain in Corneal Thickness.|Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness.|1 week and month after surgery|Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus.||Percent Gain||Standard Deviation|Mean
112412|NCT00712244|Primary|Corneal Endothelial Cell Loss|Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.|1 month after surgery|||Percent Change||Standard Deviation|Mean
112413|NCT00712179|Primary|Diagnostic|"The electromyographic (EMG) gait pattern of stroke survivors was compared with normal pattern using z-scores."|During sessions- 1 day measurement|Individuals with chronic stroke.||Z-score||Standard Error|Mean
112414|NCT00712166|Secondary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF method was used.||Percent change from baseline||Standard Error|Least Squares Mean
112415|NCT00712166|Secondary|Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28|Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
112416|NCT00712166|Other Pre-specified|The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)|Aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed. The minimum inhibitory concentration (MIC) is the lowest concentration of antimicrobial agent that inhibits visible growth of a microorganism. The MIC50 and MIC90 for PA is the MIC required to inhibit the growth of 50% or 90% of PA isolates, respectively. Given that there might be multiple PA isolates for each participant, the MIC50 and MIC90 for PA was calculated using the MIC values for all PA isolates. The MIC50 and MIC90 were calculated by treatment group.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo).||µg/mL|||Number
112417|NCT00712166|Other Pre-specified|Number of Participants Testing Positive for Other Respiratory Pathogens|Sputum/throat swab samples were collected at all visits for quantitative and qualitative culture of Burkholderia species, Stenotrophomonas maltophilia, Achromobacter xylosidans, methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), and Aspergillus species. One CFU on the culture from either a sputum or throat swab sample was considered presence of the particular organism.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Participants|||Number
112418|NCT00712166|Secondary|Number of Participants Hospitalized During Study|Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Study participants|||Number
112419|NCT00712166|Secondary|Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study|The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher’s Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.||Participants|||Number
112420|NCT00712166|Secondary|Change From Baseline in CFQ-R Physical Functioning Domain Score|The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Units on a scale||Standard Error|Least Squares Mean
112421|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 42|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 42|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Units on a scale||Standard Error|Least Squares Mean
112422|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 14|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 14|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Units on a scale||Standard Error|Least Squares Mean
112423|NCT00712166|Primary|Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis on intent-to-treat (ITT) population (received at least part of 1 dose of AZLI/placebo). Missing baseline data not imputed. Missing post-baseline data imputed with worst-case value for participants who withdrew due to an adverse event (AE)/study drug intolerance. Imputation for other missing data was last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
112424|NCT00712075|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|||units on a scale||Standard Deviation|Mean
112460|NCT00711646|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented.|Day 0-52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
112425|NCT00712075|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|||units on a scale||Standard Deviation|Mean
112426|NCT00712075|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent a higher level of functioning.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|Due to incomplete ILSS data for one participant in the CBSST group, 25 of 26 participants were included in the analyses for this measure.||units on a scale||Standard Deviation|Mean
112427|NCT00712010|Primary|Calculation of the Area Under Curve Over Baseline for Plasma Insulin|The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes from baseline|||nmole/L*min||Standard Error|Mean
112428|NCT00712010|Secondary|Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids||180 minutes||||||
112429|NCT00712010|Primary|Post-prandial Plasma Responses of Glucose Concentrations|The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes|23 subjects were investigated for AUC of glucose calculations||mmole/L*min||Standard Error|Mean
112430|NCT00711997|Primary|Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819|Number of Participants Reaching Maximal Tolerated Dose (MTD)|Week 4|All participants had to receive all 4 scheduled treatments and completed the Week 4 assessment||participants|||Number
112431|NCT00711997|Secondary|Tumor Resectability|The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.|5 to 6 weeks|||participants|||Number
112432|NCT00711997|Secondary|Tumor Response|Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment|4 weeks|||participants|||Number
112433|NCT00711880|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
112434|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment|"Subjects were asked to give their impression of the overall change in their allodynia since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’.~A summary of the number and percentage of subjects"|Day 0 - 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
112435|NCT00711880|Secondary|Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment|Intoxication scores were measured using a 100 mm Visual Analogue Scale, where 0 equalled ‘no intoxication’ and 100 equalled ‘extreme intoxication’. A negative value indicates an improvement in intoxication score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112436|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment|Subjects were asked to give their impression of the overall change in their peripheral neuropathic pain since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The number of subjects who reported an improvement is presented.|Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||participants|||Number
112437|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||number of words||Standard Deviation|Mean
112438|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||percentage of correct answers||Standard Deviation|Mean
112472|NCT00711594|Secondary|Phase II Step: Safety of BIBW 2992 as Indicated by Intensity and Incidence of Adverse Events, Graded According to CTCAE|outcome data show the number of patients with Adverse events (AE) by intensity and incidence of adverse events, graded according to CTCAE.|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
112439|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112440|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for ‘10/36 Spatial Recall' at the End of Treatment|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112441|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112442|NCT00711880|Secondary|Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment|The General Health Questionnaire-12 is designed to measure non-psychotic mental disorders. It consists of 12 questions, scored on a 0 to 3 Likert scale to measure and compare psychological morbidity levels, where 0 represents better psychological health. The total General Health Questionnaire-12 score is the unweighted sum of the 12 scores. Zero indicates the best possible psychological health, 36 indicates the worst possible psychological health.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112443|NCT00711880|Secondary|Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment|The static allodynia test involved applying pressure to a non-allodynic area (on the contralateral side to the identified allodynic area), and recording the pressure that caused pain to this area. Seventy five percent of the pressure that caused pain to the non-allodynic area (up to the subject’s pain/pressure threshold) was then applied to the allodynic area, and an 11-point Numerical Rating Scale pain score recorded (between 0 (no pain)and 10 (most intense pain imaginable)). A negative value indicates an improvement in pain score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112444|NCT00711880|Secondary|Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5sec intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes. A negative change from baseline indicates an improvement in score.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112445|NCT00711880|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment|The Pain Disability Index consisted of seven self-administered questions relating to the effect of the subject’s chronic pain on their personal life (family/home responsibilities, social activity, sexual behaviour, life-support activity, recreation, occupation and self-care). Each assessment was scored on an 11-point Numerical Rating Scale ranging from 0 (which equals ‘no disability’) to 10 (which equals ‘total disability’). The total Pain Disability Index is the unweighted sum of the seven Numerical Rating Scale scores. The maximum (worst) total score was 70.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112446|NCT00711880|Secondary|Change From Baseline in Mean Sleep Quality at the End of Treatment|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112447|NCT00711880|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale (NPS) score consisted of a series of assessments of different aspects of pain (intensity, sharpness, hot, dull, cold, sensitive, itchy, unpleasantness, and surface compared with deep), each scored using 11-point Numerical Rating Scales. The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112644|NCT00711009|Secondary|Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112448|NCT00711880|Primary|Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)|"The neuropathic pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline."|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis||units on a scale||Standard Deviation|Mean
112449|NCT00711867|Primary|Sublingual Temperature.||Within 10 minutes of arrival in PACU|Per protocol.||C||Standard Deviation|Mean
112450|NCT00711828|Secondary|Adverse Events|Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.|up to 12 cycles (28 days per cycle) of treatment|||participants|||Number
112451|NCT00711828|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
112452|NCT00711828|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years from registration|Thirteen patients achieved a CR or a PR and are included in this analysis.||months||95% Confidence Interval|Median
112453|NCT00711828|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
112454|NCT00711828|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
112455|NCT00711828|Primary|Proportion of Responses (Complete Response or Partial Response)|A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.|up to 12 cycles|||percentage of participants||95% Confidence Interval|Number
112456|NCT00711802|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])|"Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points:~Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion."|Predose and 5 timepoints according to age group (up to 12 hours postdose)|Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.||microgram*hour per milliliter (μg*hr/mL)||Standard Deviation|Mean
112457|NCT00711802|Secondary|Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit|"The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as Success or Failure by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered Success by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of “Failure” was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was “Failure.” If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was Unable to evaluate."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.||percentage of participants|||Number
112458|NCT00711802|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included possibly related or related as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.||percentage of participants|||Number
112459|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Legs|Ankle dorsiflexion, knee extension and hip flexion were assessed and scored to give a maximum of 100%. The Motricity Index score (scale 1-100) was recorded for limbs that had an associated Ashworth Scale score, which was greater than or equal to two at baseline.|Day 7 and Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
112461|NCT00711646|Secondary|Patient’s Global Impression of Change in Condition at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the change in your condition since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
112462|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Arms|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. The total arm score was the addition of the score for the 3 arm movements. One point was then added to give a maximum score of 100; minimum was 1 point. Where both arms were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition..|Day 7 and 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
112463|NCT00711646|Secondary|Change From Baseline in Mean Spasm Frequency Score at the End of Treatment|Each day subjects recorded in their diary the frequency of their spasms using the following scoring system: 0 = no spasms, 1 = one or fewer spasms per day, 2 = between one and five spasms per day, 3 = six to nine spasms per day, 4 = ten or more spasms per day or continuous contraction. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy.|Days 0 - 52|||units on a scale||Standard Deviation|Mean
112464|NCT00711646|Secondary|Change From Baseline in Mean Ashworth Scale Score at the End of Treatment|The mean Ashworth Scale score across muscle groups was calculated using only those muscle groups with a score of greater than or equal to two at baseline. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Days 0 - 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
112465|NCT00711646|Primary|Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.|"The spasticity Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your average spasticity in the last 24 hours where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline."|0-52 days|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
112466|NCT00711594|Secondary|Phase I Step: Cmax,Cmax,ss of BIBW 2992 After Multiple Oral Administration||Just before start of the treatment to Course 4 Visit 4R2|"The “treated set” of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.Some samples were excluded from the evaluation because these were taken outside the allowed time-windows.~Number of analyzed patients of BIBW 50mg cohort for Cmax,ss: 5"||ng/mL||Geometric Coefficient of Variation|Geometric Mean
112467|NCT00711594|Secondary|Phase II Step: Summary of EGFR Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
112468|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 15|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 15|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."||ng/ml||Geometric Coefficient of Variation|Geometric Mean
112469|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 1|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 1|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."||ng/ml||Geometric Coefficient of Variation|Geometric Mean
112470|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course1 Day 15|"Outcome data show the geometric mean (gMean) of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|Course 1 Day 15|Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification. No patient was treated with 30 mg during the Course 1.||ng/ml||Geometric Coefficient of Variation|Geometric Mean
112471|NCT00711594|Secondary|Phase II Step: Maximum CTC Grade During the Trial for Laboratory Parameters, Among Patients Who Experienced an Increase in CTC Grade From Baseline|outcome data show the number of patients for the maximum CTC grade during the trial for laboratory parameters, among patients who experienced an increase in CTC Grade|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.~For activated partial thromboplastin time (APTT), N = 59 For Prothrombin Time and International Normalized Ratio (PT-INR), N = 61"||participants|||Number
112645|NCT00711009|Secondary|Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
112473|NCT00711594|Secondary|Phase II Step: Overall Survival (OS)|OS was defined as the duration of time from the start of treatment to the time of death.|from start of treatment until end of follow up, up to 53 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||Months||Inter-Quartile Range|Median
112474|NCT00711594|Secondary|Phase II Step: Progression-free Survival (PFS)|PFS was defined as the duration of time from the start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to the RECIST) or death.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||Months||Inter-Quartile Range|Median
112475|NCT00711594|Secondary|Phase II Step: Duration of Clinical Benefit|Presented as duration of disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||Weeks||Full Range|Median
112476|NCT00711594|Secondary|Phase I Step: Summary of Epidermal Growth Factor Receptor (EGFR) Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
112477|NCT00711594|Secondary|Phase II Step: Duration of Objective Response|Duration of objective response was defined as the time at which RECIST was first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.||weeks||Full Range|Median
112478|NCT00711594|Secondary|Phase II Step: Time to Objective Response|Number of participants with first response at week 4, 8 and 12, assessed by investigator and independent review.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."||Number of patients|||Number
112479|NCT00711594|Secondary|Phase II Step: Clinical Benefit|Clinical benefit was defined as a RECIST assessment of complete response, partial response, or stable disease according to the best response to study treatment as defined in the previous section. Clinical benefit presented as the disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."||percentage of participants||95% Confidence Interval|Number
112480|NCT00711594|Secondary|Phase I Step: AUC0-24, AUCtau,ss of BIBW 2992 After Multiple Oral Administration|area under the concentration-time curve of BIBW 2992 over the time interval 0-24 hours (AUC0-24), Area under the concentration-time curve of Afatinib in plasma at steady state (AUCtau,ss) after multiple oral administration Pharmacokinetic was abbreviated to PK.|AUC0-24: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00 on Day 1-2 in Course 1; AUCtau,ss: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00, 48:00, 72:00 on Day 28-31 in Course 1|"“Treated set” was defined as all patients who received at least 1 dose of BIBW2992. Some samples were excluded from calculation of descriptive statistics of plasma concentration because these were taken outside the allowed time-windows but used for calculation of PK parameters.~Number of analyzed patients of BIBW 50mg:5(AUCtau,ss), 40mg:2(AUC0-24)"||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
112481|NCT00711594|Primary|Phase II Step: Objective Tumour Response According to Response Evaluation Criteria in Solid Tumours (RECIST)|The objective response (complete response [CR] and partial response [PR]) was defined as determined by the RECIST according to the best response to study treatment.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation), up to 41.3 months|"The full analysis set of patients was defined as all patients included in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."||percentage of participants||95% Confidence Interval|Number
112482|NCT00711594|Primary|Phase I Step: Safety of BIBW 2992 Assessed Based on Incidence of Dose Limiting Toxicity (DLT) and Incidence & Intensity of Adverse Events According to CTCAE||start of treatment to end of treatment|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."||participants|||Number
112483|NCT00711555|Secondary|no Significant Nausea|defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1|||%|||Number
112484|NCT00711555|Secondary|no Nausea|defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1|||%|||Number
112485|NCT00711555|Secondary|no Emesis||cycle 1, day 1|||%|||Number
112486|NCT00711555|Secondary|Complete Protection|defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1|||%|||Number
112487|NCT00711555|Primary|Complete Response|defined as a no emetic episodes and no use of rescue therapy|cycle 1, day 1|||%|||Number
112646|NCT00711009|Secondary|Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
112488|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks.|Week 8|||units on a scale (HFRDIS)||Full Range|Median
112489|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point.|Week 4|||units on a scale (HFRDIS)||Full Range|Median
112490|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization).|Baseline|||units on a scale (HFRDIS)||Full Range|Median
112491|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 8|||units on a scale (severity score)||Full Range|Median
112492|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 4|||units on a scale (severity score)||Full Range|Median
112493|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Baseline|||units on a scale (severity score)||Full Range|Median
112494|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark."|Week 8|||daily hot flashes||Full Range|Median
112495|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark."|Week 4|||daily hot flashes||Full Range|Median
112515|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
112696|NCT00710762|Secondary|Time to Death|This end point was not determined as no patients died during the trial.|9 months|This endpoint could not be calculated as no patients died.|||||
112496|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries."|Baseline|||daily hot flashes||Full Range|Median
112497|NCT00711516|Secondary|Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test|During anatomic scanning (and prior to functional runs when anatomic scanning was not performed), a modified continuous 10 minute attention task (“Psychomotor Vigilance Test [PVT]-like task,” nearly identical to the PVT but for absence of performance feedback) was run to obtain a measure of vigilance in the scanner—in this instance, the “+” symbol appeared at random (mean inter trial interval of 5 seconds, range 2 - 10 seconds) but disappeared when subject pressed a button. Subject performance speed was measured. Change in subject performance speed from Baseline to Endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline||milliseconds (ms)||Standard Error|Least Squares Mean
112498|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the thalamus.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline||Voxels||Full Range|Median
112499|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline||Voxels||Full Range|Median
112500|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels meeting pre-defined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline||Voxels||Full Range|Median
112501|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the dorsolateral prefrontal cortex.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline||Voxels||Full Range|Median
112502|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the thalamus.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline||BOLD signal intensity||Full Range|Median
112503|NCT00711516|Secondary|Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline||BOLD signal intensity||Full Range|Median
112504|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent signal (BOLD) intensity in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline||BOLD signal intensity||Full Range|Median
112505|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the dorsolateral prefrontal cortex (DLPFC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline||BOLD signal intensity||Full Range|Median
112506|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the thalamus for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
153904|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
112507|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the posterior parietal cortex (PPC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
112508|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the anterior cingulate cortex (ACC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
112509|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the dorsolateral prefrontal cortex (DLPFC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis among non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint||Voxels||Standard Error|Mean
112510|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (voxels that differ significantly from reference wave form) in the thalamus. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (response latency < 713 ms) at Endpoint||Voxels||Standard Error|Mean
112511|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels (voxels that differ significantly from reference wave form) in Posterior Parietal Cortex (PPC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had a response latency < 713 ms) at Endpoint||Voxels||Standard Error|Mean
112512|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (that differ significantly from reference wave form) in Anterior Cingulate Cortex (ACC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had response latency < 713 ms) at Endpoint||Voxels||Standard Error|Mean
112513|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels meeting the predefined threshold in DLPFC. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels (that differ significantly from reference wave form) for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test defined as subjects who had a response latency of < 713 ms at Endpoint||Activated voxels||Standard Error|Mean
112514|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between BOLD signal intensity on fMRI in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
112516|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in the ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
112517|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI over DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
112518|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
112519|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
112520|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline||Correlation Coefficient|||Number
112521|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after baseline||Correlation Coefficient|||Number
112522|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent change in BOLD signal||Full Range|Median
112523|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent change in Bold signal||Full Range|Median
112524|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline||Percent change in BOLD signal||Full Range|Median
112567|NCT00711347|Secondary|Intraocular Pressure (IOP)|Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.|1 Day Postoperative|14 patients/28 eyes in each group.||mmHg||Standard Deviation|Mean
112525|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.||Percentage change in BOLD signal||Full Range|Median
112526|NCT00711516|Secondary|Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint|The MOS-CF6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6 item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 was scored by summing responses across the 6 items and converting the total to a 0 to 100 point scale, with higher scores indicating better cognitive functioning. Change in MOS-CF6 from baseline to endpoint is reported.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Population defined as subjects who had at least one efficacy evaluation after baseline.||Units on a scale||Standard Error|Least Squares Mean
112527|NCT00711516|Secondary|Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint|Severity of sleepiness, was assessed by the Clinical Global Impression of Severity (CGI-S) at Baseline. The clinician assessed the change from baseline in the patient’s condition, as related to excessive sleepiness, in response to treatment using the CGI-C, which consisted of the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders had to be at least minimally improved from Baseline to qualify as a responder at Endpoint.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Participants|||Number
112528|NCT00711516|Secondary|Epworth Sleepiness Scale Change From Baseline to Endpoint|The patient’s evaluation of excessive daytime sleepiness was measured by the patient reported measure, ESS (Johns1991). The ESS score was based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflected a patient’s propensity to fall asleep in those situations. The ESS score was derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS ranged from 0 to 24, with a higher score indicating a greater daytime sleepiness. Change from baseline to endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full analysis set defined as subjects who had at least one efficacy evaluation after baseline||Units on a scale||Standard Error|Least Squares Mean
112529|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient had to work out how many moves the solutions required in their heads. Mean change from baseline to endpoint in number of choices to correct for hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Choices to correct||Standard Deviation|Mean
112530|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient is shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient has to work out how many moves the solutions required in their heads. Mean change from Baseline to endpoint in number of choices to correct for easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy measure after baseline||Choices to correct||Standard Deviation|Mean
112531|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Milliseconds (ms)||Standard Deviation|Mean
112532|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.||Milliseconds (ms)||Standard Deviation|Mean
112634|NCT00711009|Secondary|Mean Change From Baseline in Albumin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||grams/liter||Standard Deviation|Mean
112533|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in a single location during the simple reaction time phase. The change from baseline to endpoint in median correct latency is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Milliseconds (ms)||Full Range|Median
112534|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in any 1 of 5 locations in the 5 choice reaction time phase. The change from baseline to endpoint in median correct latency is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Milliseconds (ms)||Full Range|Median
112535|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint|"The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory as measured by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Twenty minutes following the immediate recognition test, another delayed recognition test is performed, featuring the same stimuli as in the first phase. The change from baseline to endpoint in percent correct responses of this delayed test are presented here. Subjects complete 24 trials per assessment."|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent correct trials|Participants|Standard Deviation|Mean
112536|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint|The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Immediately afterwards a recognition test is performed, in which each pattern shown earlier is presented with another pattern of similar form and color. Patient has to touch the pattern seen earlier. Change from baseline to endpoint in % correct responses with immediate recall is presented. Subjects complete 24 trials per assessment.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline||Percent correct trials|Participants|Standard Deviation|Mean
112537|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus|The outcome was the change from baseline in number of contiguous activated voxels in the thalamus on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value significantly (p<0.05), the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set||Activated voxels||Standard Error|Mean
112538|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)|The outcome was the change from baseline in number of contiguous activated voxels in the posterior parietal cortex (PPC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value with p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Activated voxels||Standard Deviation|Mean
112539|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)|The outcome was the change from baseline in number of contiguous activated voxels in the anterior cingulate cortex (ACC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline||Activated Voxels||Standard Deviation|Mean
112540|NCT00711516|Secondary|Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed|The 2-Back is a verbal working memory test in which random letters are presented visually every 4 sec, with each stimulus lasting 500 msec. Subjects are asked to make a yes/no response following each letter indicating whether it was the same or different from the letter presented two earlier. The load on working memory was the ordering, retention, updating, and manipulation of 2 letters and consideration of the relationship to a 3rd newly presented letter, which could have been a target or a nontarget. The change from baseline in response latency at endpoint is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.||Milliseconds (ms)||Standard Deviation|Mean
112635|NCT00711009|Secondary|Mean Change From Baseline in Bicarbonate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112541|NCT00711516|Primary|Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation|The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Efficacy analyses were performed on the full analysis dataset which includes those patients in the safety analysis set who had at least 1 post baseline primary efficacy assessment.||Activated voxels||Standard Deviation|Mean
112542|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 12 Months, as Measured on Fluorescein Angiography (FA)||12 months||||||
112543|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 6 Months, as Measured on Fluorescein Angiography (FA)||6 months||||||
112544|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 12 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|12 months|||μm||Full Range|Median
112545|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 6 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months|||μm||Full Range|Median
112546|NCT00711490|Secondary|Change in Visual Acuity From Baseline to 12 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|12 months|||ETDRS letters||Full Range|Median
112547|NCT00711490|Primary|Change in Visual Acuity From Baseline to 6 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months|||ETDRS letters||Full Range|Median
112548|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Posterior Insula|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
112549|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Parietal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
112550|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 2|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
112551|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 1|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
112552|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Anterior Cingulate|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
112553|NCT00711477|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
112554|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in External Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The External Eating subscale consisted of 10 items and the scores ranged from 10 (better outcome) to 50 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
112636|NCT00711009|Secondary|Mean Change From Baseline in Chloride (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
153905|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
112555|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating B Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating B subscale (diffuse emotions) consisted of 4 items and the scores ranged from 4 (better outcome) to 20 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
112556|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating A Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating A subscale (clearly labeled emotions) consisted of 9 items and the scores ranged from 9 (better outcome) to 45 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
112557|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Restrained Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores ranged from 10 (worse outcome) to 50 (better outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||units on a scale||Standard Error|Least Squares Mean
112558|NCT00711477|Secondary|Percent Change in Body Weight||Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percentage of body weight||Standard Error|Least Squares Mean
112559|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.||percent activation||90% Confidence Interval|Mean
112560|NCT00711425|Primary|Marginal Bone Adaptation|Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.||Millimeter|Participants|Standard Deviation|Mean
112561|NCT00711425|Primary|Implant Stability|Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.||ISQ|Participants|Standard Deviation|Mean
112562|NCT00711425|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).||Percentage of implants|Participants||Number
112563|NCT00711347|Secondary|Surgeon Survey|"Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported:~Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult~Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree~Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective"|Time of Surgery|||Units on a scale||Standard Deviation|Mean
112564|NCT00711347|Secondary|Aqueous Signs - Edema|"Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale:~0 = none~= mild - slight localized or generalized edema~= moderate - significant localized or generalized edema~= severe - advanced localized or generalized edema"|1 Day Postoperative|14 patients/28 eyes in each group.||Units on a scale||Standard Deviation|Mean
112565|NCT00711347|Secondary|Aqueous Signs - Flare|"Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale:~0:No-Visible flare when compared with the normal eye.~Mild-Flare visible against dark papillary background but not visible against iris background.~Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 Day Postoperative|14 patients/28 eyes in each group.||Units on a scale||Standard Deviation|Mean
112566|NCT00711347|Secondary|Aqueous Signs - Cells|Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells|1 Day Postoperative|14 patients/28 eyes in each group.||Units on a scale||Standard Deviation|Mean
112637|NCT00711009|Secondary|Mean Change From Baseline in Potassium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112568|NCT00711347|Primary|Corneal Endothelial Cell Loss|Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.|1 month|14 patients/28 eyes in each group.||Percent change||Standard Deviation|Mean
112569|NCT00711191|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer|Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1.|Baseline up to time of determination of maximum tolerated dose (MTD)|Safety population||mg/kg|||Number
112570|NCT00711191|Secondary|Carbohydrate Antigen 19-9 (CA 19-9)|CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease.|At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112571|NCT00711191|Secondary|18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)|FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment.|Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112572|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR)|Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production.|Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112573|NCT00711191|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112574|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112575|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112576|NCT00711191|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast analyzed using a noncompartmental approach to estimate individual participant values.|Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112577|NCT00711191|Secondary|Maximum Serum Concentration (Cmax)||Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112578|NCT00711191|Secondary|Time to Progression|Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions.|Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.|||||
112579|NCT00711191|Secondary|Progression Free Survival (PFS)|PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95% CI for 50% quartile based on Brookmeyer and Crowley Method. Criteria for progression also included unequivocal progression of existing nontarget lesions.||months||95% Confidence Interval|Median
112580|NCT00711191|Secondary|Overall Survival (OS)|OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method.||months||95% Confidence Interval|Median
112581|NCT00711191|Secondary|Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response|Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution.||percentage of participants||95% Confidence Interval|Number
112582|NCT00711191|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|"Any of the following during first cycle of treatment and attributable to CP-870893:~afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia)."|Baseline up to Cycle 1 / Day 28|Safety population: all participants who received any study treatment. Cubic millimeters (mm^3).||participants|||Number
112583|NCT00711113|Primary|Marginal Bone Adaptation|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At baseline (loading) and at 5 year follow-up|Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.||Millimeter|Participants|Standard Deviation|Mean
112584|NCT00711113|Primary|Implant Stability|Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.||units on a scale|Participants|Standard Deviation|Mean
112585|NCT00711113|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.||percentage of implants|Participants||Number
112586|NCT00711100|Primary|Abstinence From Cigarettes|Abstinence from cigarettes during Abstinence Phase.|2 and 4 weeks|At the end of Sampling Phase, subjects chose a preferred product to use during a two week Abstinence Phase.||participants|||Number
112587|NCT00711100|Primary|Product Preference|Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).|2 weeks|||participants|||Number
112588|NCT00711087|Primary|A Change in DLPP of 20cm H2O at Day 30 and Day 120 in the BTX-A Injected Group (Group 1) Compared to the Sham Saline Injected Group (Group 2).|This outcome measure was not able to be determined due to the subject being lost to follow-up. The subject no longer returns phone calls or visits the clinic.|2.5 years|Early spinal cord injury|||||
112589|NCT00711022|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5-year follow-up|Per protocol analysis presented, this includes implants loaded within 24 hours from implant placement (306 implants in 51 subjects), of these 20 implants failed during the 5 year follow-up period.||percentage of implants|Participants||Number
112590|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams/cm^2||Standard Deviation|Mean
112591|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112592|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112593|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112638|NCT00711009|Secondary|Mean Change From Baseline in Sodium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
153934|NCT00352053|Secondary|Change From Baseline to Week 240 in HIV-1 RNA||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
112594|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112595|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112596|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112597|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112598|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112599|NCT00711009|Secondary|Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112600|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112601|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112602|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112603|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||grams||Standard Deviation|Mean
112604|NCT00711009|Secondary|Mean Change From Baseline in Mid-Thigh Measurement (cm)|Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
112605|NCT00711009|Secondary|Mean Change From Baseline in Hips Measurement (cm)|Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
112606|NCT00711009|Secondary|Mean Change From Baseline in Mid-Arm Measurement (cm)|Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
112607|NCT00711009|Secondary|Mean Change From Baseline in Waist Measurement (cm)|Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant’s waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.||cm||Standard Deviation|Mean
112639|NCT00711009|Secondary|Mean Change From Baseline in Calcium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112608|NCT00711009|Secondary|Mean Change From Baseline in Chest Measurement (cm)|Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant’s chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||cm||Standard Deviation|Mean
112609|NCT00711009|Secondary|Mean Change From Baseline in Temperature (°F)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||°F||Standard Deviation|Mean
112610|NCT00711009|Secondary|Mean Change From Baseline in Weight (kg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||kg||Standard Deviation|Mean
112611|NCT00711009|Secondary|Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||beats per minute||Standard Deviation|Mean
112612|NCT00711009|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||mm Hg||Standard Deviation|Mean
112613|NCT00711009|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||mm Hg||Standard Deviation|Mean
112614|NCT00711009|Secondary|Mean Change From Baseline in Urine pH||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||pH||Standard Deviation|Mean
112615|NCT00711009|Secondary|Mean Change From Baseline in Urine Specific Gravity|Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||ratio of urine density to water density||Standard Deviation|Mean
112616|NCT00711009|Secondary|Mean Change From Baseline in Insulin (Picomoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||picomoles/liter||Standard Deviation|Mean
112617|NCT00711009|Secondary|Mean Change From Baseline in Leptin (Nanograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||nanograms/milliliter||Standard Deviation|Mean
112618|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||picograms/milliliter||Standard Deviation|Mean
112619|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||picograms/milliliter||Standard Deviation|Mean
112620|NCT00711009|Secondary|Mean Change From Baseline in Lactate (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||millimoles/liter||Standard Deviation|Mean
112621|NCT00711009|Secondary|Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||nanograms/liter||Standard Deviation|Mean
112622|NCT00711009|Secondary|Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micrograms/milliliter||Standard Deviation|Mean
112623|NCT00711009|Secondary|Mean Change From Baseline in Magnesium (Millimoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||millimoles/liter||Standard Deviation|Mean
112624|NCT00711009|Secondary|Mean Change From Baseline in Lipase (Units/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
112625|NCT00711009|Secondary|Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
112626|NCT00711009|Secondary|Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||millimoles/liter||Standard Deviation|Mean
112627|NCT00711009|Secondary|Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||milliliters/second||Standard Deviation|Mean
112628|NCT00711009|Secondary|Mean Change From Baseline in Triglycerides (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112629|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)||Baseline to Week 96|Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.||ratio||Standard Deviation|Mean
112630|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112631|NCT00711009|Secondary|Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112632|NCT00711009|Secondary|Mean Change From Baseline in Cholesterol (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||micromoles/liter||Standard Deviation|Mean
112633|NCT00711009|Secondary|Mean Change From Baseline in Total Protein (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||grams/liter||Standard Deviation|Mean
112647|NCT00711009|Secondary|Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
112648|NCT00711009|Secondary|Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||units/liter||Standard Deviation|Mean
112649|NCT00711009|Secondary|Mean Change From Baseline in Basophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
112650|NCT00711009|Secondary|Mean Change From Baseline in Eosinophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
112651|NCT00711009|Secondary|Mean Change From Baseline in Monocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
112652|NCT00711009|Secondary|Mean Change From Baseline in Lymphocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
112653|NCT00711009|Secondary|Mean Change From Baseline in Neutrophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
112654|NCT00711009|Secondary|Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
112655|NCT00711009|Secondary|Mean Change From Baseline in Platelet Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^9/liter||Standard Deviation|Mean
112656|NCT00711009|Secondary|Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||number of cells x 10^12/liter||Standard Deviation|Mean
112657|NCT00711009|Secondary|Mean Change From Baseline in Hematocrit (Fraction)|Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||% by volume of packed RBCs in blood||Standard Deviation|Mean
112658|NCT00711009|Secondary|Mean Change From Baseline in Hemoglobin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||grams/liter||Standard Deviation|Mean
112659|NCT00711009|Secondary|Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication|The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.||Scores on a scale||Standard Deviation|Mean
112660|NCT00711009|Secondary|Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication|The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.||Scores on a scale||Standard Deviation|Mean
112661|NCT00711009|Secondary|Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)|The Effectiveness Scale of the TSQM evaluates the participant’s satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.||Scores on a scale||Standard Deviation|Mean
112662|NCT00711009|Secondary|Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||Scores on a scale||Standard Error|Mean
112663|NCT00711009|Secondary|Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.||Scores on a scale||Standard Error|Mean
112717|NCT00710424|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented.|Day 0 - Day 133|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
112664|NCT00711009|Secondary|Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir|Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/mL to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.||Participants|||Number
112665|NCT00711009|Secondary|Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.|Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/ml to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.||Participants|||Number
112666|NCT00711009|Secondary|Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672|Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.|Baseline to Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
112667|NCT00711009|Secondary|Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit||Baseline to Week 96|Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.||cells/microliter||Standard Error|Mean
112668|NCT00711009|Primary|Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values|Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.|Baseline to Week 96|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.||Percentage of participants|||Number
112669|NCT00711009|Secondary|Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 96|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
112670|NCT00711009|Primary|Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.|Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.||Percentage of participants|||Number
112671|NCT00711009|Primary|Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 48|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
112672|NCT00710996|Primary|Photostress Recovery Time in Seconds.|The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.|3 months|||seconds||Standard Deviation|Mean
112673|NCT00710970|Primary|Sustained Stable Disease is Considered to be Clinically Important. Hence, 4-month Freedom From Progression (FFP) (Stable Disease + Partial Response + Complete Response) is Chosen as the Primary End-point Instead of Response Rate.||4 months|||participants|||Number
112674|NCT00710970|Primary|Tamoxifen : Tamoxifen is Administered at 20 mg/Day as a Single Daily Oral Dose. Tamoxifen is Continued Until Progressive Disease or Intolerable Grade 3 or 4 Side Effects Occur Due to Tamoxifen.||To progression||||||
112718|NCT00710424|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End of Treatment|The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||Tablets||Standard Deviation|Mean
112675|NCT00710944|Primary|Implant Survival|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|12 months after implant placement|Per protocol analysis presented, this includes implants immediately loaded (Group A: 55 implants in 55 subjects, Group B: 58 implants in 58 subjects, Group C: 19 implants in 19 subjects), of these 5 implants in total failed within 12 months after implant placement.||percentage of implants|Participants||Number
112676|NCT00710931|Primary|Binocular Visual Acuity at Distance, Near and Intermediate|Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery|||LogMAR||Standard Deviation|Mean
112677|NCT00710905|Primary|Binocular Visual Acuity at Near, Intermediate and Distance|Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery|||LogMAR||Standard Deviation|Mean
112678|NCT00710879|Secondary|Solution Utlility|The Utility was determined based on the results of the efficacy and safety evaluations.|3 months, 6 months|All Eligible, Dispensed Eyes||Eyes|Participants||Number
112679|NCT00710879|Secondary|Solution Related AE's and Lens Changes|Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.|3 months, 6 months|All Eligible, Dispensed Eyes||Eyes|Participants||Number
112680|NCT00710879|Primary|Antimicrobial Efficacy|Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae|2 weeks, 3 months|All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.||Eyes|Participants||Number
112681|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol||participants|||Number
112682|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Infants 6-11 Months|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol||participants|||Number
112683|NCT00710866|Primary|Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
112684|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)||27-46 days after the second dose|Per Protocol||participants|||Number
112685|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
112686|NCT00710866|Primary|Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
112687|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
112688|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol||participants|||Number
112689|NCT00710840|Secondary|Functional Performance: Stair Climb Test|This outcome measures the time (seconds) it takes to climb up and back down 12 steps.|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||Seconds||Standard Deviation|Mean
112690|NCT00710840|Primary|Knee Range of Motion|Knee Flexion Active Range of Motion (AROM)|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||degrees||Standard Deviation|Mean
112691|NCT00710840|Secondary|Functional Performance: 6 Minute Walk (6MW) Distance||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||Meters||Standard Deviation|Mean
112692|NCT00710840|Primary|Quadriceps Muscle Force||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks|||Nm/kg||Standard Deviation|Mean
112693|NCT00710814|Primary|Weight Change (in kg.) After Each Intervention|"For the Leptin Intervention, 16 week values were compared to baseline for those who received Leptin in the first period, and 32 week values were compared to 16 week values in those who received Leptin in the second period.~For the Placebo Intervention, 16 week values were compared to baseline for those who received Placebo in the first period, and 32 week values were compared to 16 week values in those who received Placebo in the second period."|0 weeks, 16 weeks and 32 weeks|||kg weight change||95% Confidence Interval|Mean
112694|NCT00710762|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters|Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|First drug administration until 28 days after last drug administration, up until 309 days|Treated set||Percentage of participants|||Number
112695|NCT00710762|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First drug administration until 28 days after last drug administration,up until 309 days|Treated set||percentage of participants|||Number
112697|NCT00710762|Secondary|Time to Tumour Progression|"Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.~For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:~Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.~Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD."|9 months|Treated set||days||95% Confidence Interval|Median
112698|NCT00710762|Secondary|PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)|The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|12 weeks (after 3 months) and 24 weeks ( after 6 months)|Treated set||percent probability of PFS||95% Confidence Interval|Number
112699|NCT00710762|Primary|PFS Rate at 36 Weeks (After 9 Months)|The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|36 weeks (after 9 months)|Treated set.||percent probability of PFS||95% Confidence Interval|Number
112700|NCT00710749|Primary|Mean Urine Flow Rate|Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.|At every voiding event during approximately one week.|Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems.||ml/s||Standard Deviation|Mean
112701|NCT00710606|Secondary|Mean Endometrial Proliferation|The mean endometrial proliferation from week 1, week 2 and week3|Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.||millimeters||Standard Deviation|Mean
112702|NCT00710606|Secondary|Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up|Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter > 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).|continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.||Participant w/follicular diameter >=13mm|||Number
112703|NCT00710606|Primary|Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol|Serum concentrations were obtained from thirty-seven women completed follow-up.|Measurements at Week 3 and Week 6 continuous ring use|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.||ng/L||95% Confidence Interval|Geometric Mean
112704|NCT00710554|Secondary|Incidence of Adverse Events as a Measure of Subject's Safety.|The number of subjects that reported an adverse event in this study is presented.|19 weeks|All subjects were included in this analysis.||participants|||Number
112705|NCT00710554|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)|Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|Days 0-7 and Days 92-98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||number of tablets||Standard Deviation|Mean
112706|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112707|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112708|NCT00710554|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112709|NCT00710554|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||participants|||Number
112710|NCT00710554|Secondary|Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)|Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112711|NCT00710554|Secondary|Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112712|NCT00710554|Secondary|Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112713|NCT00710554|Secondary|Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112714|NCT00710554|Primary|Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)|"The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|Day 7 to Day 98|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112715|NCT00710424|Primary|Number of Responders at the 30% Improvement Level at the End of Treatment|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period."|Day 0 - Day 98|All subjects who were randomised and received at least one actuation of study medication were included in the analysis. Subjects with no data during the primary period (i.e. unknown response) were included in the analysis, and were classed as non-responders.||participants|||Number
112716|NCT00710424|Secondary|Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment|Subjects rated their intoxication levels on a scale of 0-10, where 0 equals “no intoxication” and 10 equals “extreme intoxication”. A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112991|NCT00708942|Primary|Complete Response Rate|"Based on histology, cytology and HPV status. Complete response is defined as normal pathology, normal cytology and negative HPV."|6 month|Per protocol population. Patients with major protocol violations excluded.||percentage of no. of patients analyzed|||Number
112719|NCT00710424|Secondary|Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale|The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112720|NCT00710424|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment|The brief pain inventory (short form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The pain severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112721|NCT00710424|Secondary|Subject Global Impression of Change at the End of Treatment|The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||participants|||Number
112722|NCT00710424|Secondary|Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment|"The sleep quality Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your sleep quality in the last 24 hours where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment)."|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112723|NCT00710424|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period.|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112724|NCT00710424|Primary|The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis."|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
112725|NCT00710385|Secondary|"Drug Liking"|"Participant's subjective ratings of how much they Like the dose they just received on a scale of 0 -100."|Peak (highest) rating obtained following drug administration throughout the entire 3 hr session|||units on a scale||Standard Error|Mean
112726|NCT00710385|Primary|Drug's Breakpoint|"Measure of a drug's reinforcing effects. The Breakpoint is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested"|Single measurement taken following each of the 7 IV experimental doses|Heroin users, not seeking treatment||number of clicks on a mouse||Standard Deviation|Mean
112727|NCT00710203|Other Pre-specified|Evidence of Texture Irregularities|The physician assessed evidence of texture irregularities.|6 to 12 weeks|||lesions|||Number
112728|NCT00710203|Other Pre-specified|Evidence of Scar|The physician assessed evidence of scar.|6 to 12 weeks|||lesions|||Number
112729|NCT00710203|Other Pre-specified|Evidence of Hyperpigmentation|The physician assessed evidence of hyperpigmentation.|6 to 12 weeks|||lesions|||Number
112730|NCT00710203|Other Pre-specified|Evidence of Hypopigmentation|The physician assessed evidence of hypopigmentation.|6 to 12 weeks|||lesions|||Number
112731|NCT00710203|Primary|Percent Clearance of All Lesions|The physician assessed percent clearance of all treated lesions and the control lesion.|6 to 12 weeks|||percentage of lesion clearance|Participants|Standard Deviation|Mean
112732|NCT00710021|Secondary|Percent of Participants With Adverse Events of Grade 3 or Above|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From start of study treatment through Week 12|Safety||Percent of participants|||Number
112762|NCT00709891|Primary|Percentage of Participants With a Diagnosis of ≥ CIN2|A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the Baseline period (up to 12 weeks)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).||Percentage of participants|||Number
112733|NCT00710021|Secondary|Renal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Renal-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112734|NCT00710021|Secondary|Ophthalmic BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Ophthalmic-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112735|NCT00710021|Secondary|Neuropsychiatric BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Neuropsychiatric-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112736|NCT00710021|Secondary|Musculoskeletal BILAG Status at Week 12|Outcome measure description: The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Musculoskeletal-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112737|NCT00710021|Secondary|Mucocutaneous BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Mucocutaneous-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112738|NCT00710021|Secondary|Hematological BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Hematological-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112739|NCT00710021|Secondary|Gastrointestinal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Gastrointestinal-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112740|NCT00710021|Secondary|Constitutional BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Constitutional-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112741|NCT00710021|Secondary|Cardiorespiratory BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Cardiorespiratory-specific” body system.|Week 12|Modified Intent-to-Treat with available data||Percent with grade A or B|||Number
112742|NCT00710021|Secondary|Change in SELENA-SLEDAI Total Score From Baseline to Week 12|The modified Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. Positive change in the SELENA-SLEDAI score indicate increased disease activity.|0, Week 12|Modified Intent-to-Treat with available data||Change in Scores on a Scale||Standard Deviation|Mean
112743|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 6|Modified Intent-to-Treat with available data||Percent of participants|||Number
112744|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 12|Modified Intent-to-Treat with available data||Percent of participants|||Number
112745|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 6|Outcome measure description: C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
112746|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 12|C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
112747|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 6|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
112748|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 12|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||mg/dL||Standard Deviation|Mean
112749|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
112750|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
112751|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
112752|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
112763|NCT00709878|Primary|Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.||6 months|||Total number of cases|||Number
112992|NCT00708877|Primary|Transplant-related Mortality|Determined mortality-related transplant outcomes.|2 years|Entire cohort was used for analysis.||participants|||Number
112753|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
112754|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. This gene encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data||qRT-PCR fold change||Standard Deviation|Mean
112755|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 6|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.||Percent of participants|||Number
112756|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 12|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.||Percent of participants|||Number
112757|NCT00710021|Secondary|Percent of Participants With an IFN Alpha Signature Response at Week 6|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.||Percent of participants|||Number
112758|NCT00710021|Primary|Percent of Participants With an IFN Alpha Signature Response at Week 12|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.||Percent of participants|||Number
112759|NCT00709956|Secondary|Borg Dyspnea Score|"The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled extremely severe, or the worst possible dyspnea imaginable. Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.||scores on a scale||Standard Deviation|Mean
112760|NCT00709956|Primary|6-minute-walk Distance (6MWD)|"The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk.~It was conducted by a trained member of the site staff who was listed on the site’s delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.||meters||95% Confidence Interval|Least Squares Mean
112761|NCT00709891|Secondary|Percentage of Participants With a Diagnosis of ≥ CIN3|A diagnosis of ≥ CIN3 (cervical intraepithelial neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the study (up to 5 years, 1 month)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).||Percentage of participants|||Number
112764|NCT00709852|Secondary|Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers|From the quantitative signal intensity values assessed by the BR, the percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced was calculated.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of lesion enhancement||Standard Deviation|Mean
112765|NCT00709852|Secondary|Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers|Two BRs independently provided the number of contrast-enhanced lesions for gadobutrol and gadoteridol. In cases of disagreement between the readers, an independent adjudicator provided the number of contrast-enhanced lesions. The adjudicator results were used in the analysis in the cases of disagreement between the original readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
112766|NCT00709852|Secondary|Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher|Percentage of participants for which blinded readers said image quality was higher|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112767|NCT00709852|Secondary|Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers|The BRs evaluated the relative image quality of the gadobutrol-enhanced T1w MR images and the gadoteridol-enhanced T1w MR images in a paired fashion on a 5-point scale where 1 = image on right was worse, 2 = image on right was slightly worse, 3 = both images were the same, 4 = image on right was slightly better, and 5 = image on right was better.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112768|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the combined unenhanced/gadobutrol-enhanced MR image sets and the combined unenhanced/gadoteridol MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112769|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadoteridol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112770|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadobutrol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112771|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112772|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112773|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112774|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112775|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112776|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112777|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112778|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112779|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112780|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112781|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112782|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112783|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
113060|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.|Week 48|ITT Analysis Set||percentage of participants|||Number
112784|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112785|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112786|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112787|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112788|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112789|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112790|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112791|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112809|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
112792|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112793|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112794|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112795|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112796|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112797|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112798|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112799|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112840|NCT00709826|Secondary|Overall Survival||Randomization then every other cycle|||Months||95% Confidence Interval|Median
113109|NCT00708071|Secondary|Participants With Hematoma/Seroma During the Study|Investigators assessed each side of the face for the presence of hematoma/seroma|Through Postoperative Day 14 (± 1)|Per protocol||participants|||Number
112800|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112801|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
112802|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
112803|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
112804|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
112805|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
112806|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
112807|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112808|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112810|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112811|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112812|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112813|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
112814|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112815|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112816|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112817|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
112818|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112819|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112820|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112821|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
112822|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
112823|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112824|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
112825|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112826|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112827|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112828|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112829|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112830|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
113110|NCT00708071|Secondary|Participants With Hematoma/Seroma|Investigators assessed each side of the face for the presence of hematoma/seroma|Days 0, 1, 3, 5, 7,10, and 14|Per Protocol||Participants|||Number
113111|NCT00708071|Secondary|Total Volume of Drainage on Each Side of the Face||24 hours postoperative|Per Protocol||mL||Full Range|Median
112831|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112832|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112833|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112834|NCT00709852|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||lesions||Standard Deviation|Mean
112835|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112836|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112837|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
112838|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI, combined unenhanced and gadobutrol-enhanced MRI, and combined unenhanced and gadoteridol-enhanced MRI, excluding the sample participants (the first participant from each study site).||scores on a scale||Standard Deviation|Mean
112839|NCT00709826|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Randomization then every other cycle|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio.||Months||95% Confidence Interval|Median
112841|NCT00708734|Primary|Gait and Balance Measures|Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.|5 months|The purpose of this pilot study was to evaluate the feasibilty of a structured, group exercise program in this population. Only 3 of 10 participants completed the study, due to high attrition, the project was considered unfeasible and data was not analysis.|||||
112842|NCT00708708|Secondary|Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.|Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)|Safety analysis set included all participants with available post-baseline safety data.||participants|||Number
112843|NCT00708708|Secondary|Criteria for Treatment Resumption|Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||participants|||Number
112844|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Recommendation of Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?” Participants responded as yes or no to the question. Results are reported for participant’s likeliness to recommend therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points. Results are not reported for before Cycle 4, 5, 6, and after Cycle 5 as no participant was evaluable at these time points.||participants|||Number
112845|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Preference to Continuous Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “If possible, would you prefer a continuous therapy without drug-free interval?” Participants responded as yes or no to the question. Results are reported for participant’s preference towards continuous therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||participants|||Number
112846|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Comfort in Everyday Life|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval means more comfort in my everyday life.” Results are reported for participant’s perception of comfort of life during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112847|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reminder of Disease|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “During drug-free interval I will not be reminded permanently of my disease.” Results are reported for participant’s perception of reminder of disease during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112848|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval reduces the risk for adverse drug reactions.” Results are reported for participant’s perception of risk of adverse drug reactions.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112874|NCT00708708|Secondary|Static Physician Global Assessment (sPGA) of Disease Activity|Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112849|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How much were you satisfied with the condition of your skin during the first half of the drug-free interval?” and “How much were you satisfied with the condition of your skin during the second half of the drug-free interval?” Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant’s satisfaction with their skin condition during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112850|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Disease Activity|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the activity of your disease during the first half of the drug-free interval?” and “How would you assess the activity of your disease during the second half of the drug-free interval?” Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant’s perception of disease activity during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112851|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?” After the drug-free interval participants were asked, “To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?” Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant’s perception of effective therapy after drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112852|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Relapse of Symptoms|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How much are you concerned about a relapse of symptoms?” After the drug-free interval participants were asked, “Were you concerned about a relapse of symptoms during the drug-free interval?” Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant’s perception of relapse of symptoms.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112853|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Duration|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the length of the current drug-free interval?” Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant’s perception of the duration of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112854|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “Do you basically like the idea of a drug-free interval?” After the drug-free interval participants were asked, “How did you like the current drug-free interval?” Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant’s liking of the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112855|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reason for Returning to Practice|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “Why did you return to the practice today?” Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||participants|||Number
112944|NCT00709124|Secondary|Overall Body Strength: Hand Grip Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
112856|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Length of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How long do you expect the drug-free interval to last for?” After the drug-free interval participants were asked, “How long did the drug-free interval last?” Results are reported for participant’s perception of the length of drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.||months||Standard Deviation|Mean
112857|NCT00708708|Secondary|Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)|"Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here n’=number of participants evaluable at the specified time points for the given cycles.||units on a scale||Standard Deviation|Mean
112858|NCT00708708|Secondary|Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score|"Effect of drug free interval on DLQI was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst)."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ’n’=number of participants evaluable at the specified time points for the given cycles.||units on a scale||Standard Deviation|Mean
112859|NCT00708708|Secondary|Effect of Drug-Free Interval on Patient’s Global Assessment of Disease Activity (PatGA)|"Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
112860|NCT00708708|Secondary|Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications|Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Prior to study, Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.||Euros||Standard Deviation|Mean
112861|NCT00708708|Secondary|Average Cost of Treatment by Disease Severity|Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for the given disease severities.||Euros||Standard Deviation|Mean
112862|NCT00708708|Secondary|Annual Costs for Treatment With Etanercept|Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.||Euros||Standard Deviation|Mean
112863|NCT00708708|Secondary|Number of Participants With at Least 1 Concomitant Medication|Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.|Cycle 1 Week 0 up to Cycle 6 Week 24|Safety analysis set included all participants with available post-baseline safety data.||participants|||Number
112945|NCT00709124|Secondary|Overall Body Strength: 6 Bilateral Muscle Groups in Arms and Legs (MRC Composite Score) Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
112864|NCT00708708|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112865|NCT00708708|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112866|NCT00708708|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112867|NCT00708708|Secondary|Patient’s Global Assessment of Disease Activity (PatGA)|Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set included all participants >=18 years of age, confirmed diagnosis of plaque psoriasis, had not received treatment with etanercept previously and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112868|NCT00708708|Secondary|Percentage of Time on Treatment Over Entire Period|Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1).|Cycle 1 up to Cycle 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of entire treatment period||Standard Deviation|Mean
112869|NCT00708708|Secondary|Percentage of Time on Treatment in First Year|Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.|Year 1|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of first year||Standard Deviation|Mean
112870|NCT00708708|Secondary|Cumulative Dose of Etanercept Per Year|Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n' = participants evaluable at the specified time points for this outcome measure.||mg||Standard Deviation|Mean
112871|NCT00708708|Secondary|Number of Injections Per Year|Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable at the specified time points for this outcome measure.||injections||Standard Deviation|Mean
112872|NCT00708708|Secondary|Patient Global Assessment of Efficacy|Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.||participants|||Number
112873|NCT00708708|Secondary|Physician Global Assessment of Efficacy|Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.||participants|||Number
112946|NCT00709124|Secondary|Individual Muscle Strength: Pretibial, Triceps Surae, and Quadriceps (MRC Score) Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
112875|NCT00708708|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points for each arm, respectively.||percentage of BSA||Standard Deviation|Mean
112876|NCT00708708|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
112877|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 6|Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 5 Week 24 up to Cycle 6 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
112878|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 5|Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 4 Week 24 up to Cycle 5 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
112879|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 4|Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 3 Week 24 up to Cycle 4 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
112880|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 3|Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 2 Week 24 up to Cycle 3 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post-baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
112881|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 2|Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 1 Week 24 up to Cycle 2 Week 0|Efficacy analysis set: all participants greater than or equal to (>=) 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.||weeks||95% Confidence Interval|Mean
112882|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
113027|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||hours||Full Range|Median
112883|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of Infant Series (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
112884|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
112885|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.||Percentage of participants|||Number
112886|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
112887|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
112888|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
112889|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.||Percentage of participants|||Number
112890|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.|Toddler Dose (12 months of age)|Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose.||mcg/mL||95% Confidence Interval|Geometric Mean
112891|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 3 of infant series (6 months of age)|Evaluable 3-Dose Infant Immunogenicity population||mcg/mL||95% Confidence Interval|Geometric Mean
112892|NCT00708682|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 2 of infant series (4 months of age)|Evaluable 2-Dose Infant Immunogenicity population||mcg/mL||95% Confidence Interval|Geometric Mean
112947|NCT00709124|Primary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score|Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups|At hospital discharge|||units (range 0-30; higher is better)||Standard Deviation|Mean
113112|NCT00708071|Secondary|Resolution of Edema as Assessed by Investigators.|Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol||participants|||Number
112893|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
112894|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after dose 2 of the infant series (5 months of age)|Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
112895|NCT00708682|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
112896|NCT00708643|Secondary|Corneal Staining|A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.|||units on a scale||Standard Error|Least Squares Mean
112897|NCT00708643|Secondary|Tarsal Hyperemia|Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
112898|NCT00708643|Secondary|Tarsal Roughness|Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
112899|NCT00708643|Primary|Upper Lid Margin Staining|Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.||units on a scale.||Standard Error|Least Squares Mean
112900|NCT00708643|Primary|Lens Comfort|"Rating of lens comfort by rating agreement to the following statement:~The lenses I am wearing are comfortable.~Rating using the following scale:~1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames."|At 3,7,10,13,17,21,24, and 27 days|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
112901|NCT00708643|Primary|Limbal Hyperemia|Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.||units on a scale||Standard Error|Least Squares Mean
112902|NCT00709761|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.|Start of treatment to disease progression or death (up to Week 131)|ITT Population||weeks||95% Confidence Interval|Median
112903|NCT00709761|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the start of treatment until the earliest date of disease progression or death due to breast cancer.|Start of treatment to disease progression or death (up to Week 131)|ITT Population||weeks||95% Confidence Interval|Median
112904|NCT00709761|Secondary|Time to Response (TTR)|TTR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first).|Start of treatment to first documented response (CR or PR) (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.||weeks||95% Confidence Interval|Median
112905|NCT00709761|Secondary|Duration of Response (DOR)|DOR was defined for the subset of participants who showed a confirmed CR or PR, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|First documented response (CR or PR) to disease progression or death (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.||weeks||95% Confidence Interval|Median
112906|NCT00709761|Secondary|Overall Survival (OS)|OS was defined as the time from the start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. OS could not be analyzed because only 13 participants had died as of data cut off, and data were not mature (greater than 75% of the participants were censored for the endpoint).|Start of treatment to death (up to Week 131)|ITT Population|||||
113028|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)|Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85.|Day 85|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
112907|NCT00709761|Primary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||percentage of participants|||Number
112908|NCT00709722|Secondary|Treatment Days With Corticosteroids of <= 7.5 mg/Day|"Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day).~OCS dosage was maintained, decreased or increased according to the response to DSG.~The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle."|1st and 9th Cycle|ITT population||Days||Full Range|Mean
112909|NCT00709722|Secondary|SELENA-SLEDAI Score|The “Safety of Estrogen in Lupus Erythematosus National Assessment – systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity.|Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks|ITT population||Score on a scale||Full Range|Mean
112910|NCT00709722|Primary|Complete and Partial Response Rate|A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.|Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks|ITT population||Percentage of participants|||Number
112911|NCT00709618|Secondary|Overall Survival|OS is defined as the time from the start of study treatment to the date of death. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Overall survival was not assessed because the study was terminated due to low screening and a low enrollment rate after 3 years. There were no-survival follow-up visits required.|From the start of study treatment to the date of death, assessed for up to 3 years||||||
112912|NCT00709618|Secondary|Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine|Qualitative and quantitative toxicities associated with the combination of lapatinib and vinorelbine during the study are those adverse events (AEs) that are judged to be related to the study treatment by the investigator. Those AEs occuring in more than 5 participants in the ITT Population are listed here.|From the start of study medication until disease progression, assessed every 4 weeks for up to 2 years|ITT Population||participants|||Number
112913|NCT00709618|Secondary|Time to Progression (TTP), as Assessed by the Investigator|TTP is defined as the time from the start of treatment until the earliest date of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to breast cancer, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).||weeks||95% Confidence Interval|Median
112914|NCT00709618|Secondary|Time to Response, as Assessed by the Investigator|Time to response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.||weeks||95% Confidence Interval|Median
112915|NCT00709618|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the first documented evidence of CR or PR until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to any cause, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.||weeks||95% Confidence Interval|Median
112962|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
123894|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
112916|NCT00709618|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the time from the start of treatment until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).||weeks||95% Confidence Interval|Median
112917|NCT00709618|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesions)/recurrence.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|Intent-to-Treat (ITT) Population: participants who received >=1 dose of investigational product. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.||participants|||Number
112918|NCT00709592|Secondary|Chronic Graft-Versus-Host Disease (GVHD)||2 year GVHD rate|||percentage of participants|||Number
112919|NCT00709592|Secondary|Acute Graft-Versus-Host Disease (GVHD)||2 year rate (%)|||percentage of participant|||Number
112920|NCT00709592|Secondary|Donor Lymphocyte Infusion||2 year rate of DLI|||percentage of participants|||Number
112921|NCT00709592|Secondary|Relapse|Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans.|2 year relapse rate (%)|||Percent patients relapsing|||Number
112922|NCT00709592|Secondary|Event-free Survival||2 years|||percentage of participants|||Number
112923|NCT00709592|Secondary|Treatment Related Mortality||Day 100|||percentage of patients|||Number
112924|NCT00709592|Secondary|Survival||2-year survival rate (%)|||percentage of patient surviving|||Number
112925|NCT00709592|Secondary|Engraftment of Donor Hematopoietic Stem Cells, as Measured by Neutrophil and Platelet Counts||12 day median||||||
112926|NCT00709592|Primary|The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine.|A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).|Up to 9 months following transplant|||participants|||Number
112927|NCT00709319|Primary|Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months|Change in thickness is followup thickness minus baseline thickness.|Baseline to 6 months|||participants|||Number
112928|NCT00709319|Primary|Percent of Participants With Change in Visual Acuity From Baseline to Six Months||Baseline to 6 months|||Percentage of Participants||95% Confidence Interval|Number
112929|NCT00709319|Secondary|Surgical Complications From Baseline to Six Months|Including intraoperative and perioperative medical complications. Same subject could have more than one complication|Baseline to 6 months|||Participants|||Number
112930|NCT00709319|Primary|Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline|Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.|Baseline to 6 Months|||microns||Inter-Quartile Range|Median
112931|NCT00709319|Primary|Visual Acuity|Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 6 months|||Units on a scale||Inter-Quartile Range|Median
112932|NCT00709228|Primary|Number of HCV LVL G1 Participants Who Relapsed|Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.|Week 24 of follow-up|The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.||Participants|||Number
112933|NCT00709124|Secondary|Subgroup Analysis|For patients with >= 7 days of mechanical ventilation, we will compare the 2 groups for the following outcomes: Lower extremity muscle strength, mean change in MRC score from baseline to ICU discharge, mean change in MRC score from baseline to hospital discharge, and composite whole body MRC score at ICU dischare and at hospital discharge.|See description||||||
112934|NCT00709124|Secondary|ICU Delirium||Number of days with delirium in the ICU||||||
112935|NCT00709124|Secondary|Mean Change in Subject’s Lower Extremity MRC Composite Score From Baseline||At ICU and Hospital discharge||||||
112936|NCT00709124|Secondary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score||At ICU discharge||||||
112937|NCT00709124|Secondary|Hospital Discharge Destination (e.g., Home, Rehab Facility)||Hospital discharge||||||
112938|NCT00709124|Secondary|Total Hospital Charges||Hospital discharge||||||
112939|NCT00709124|Secondary|ICU and In-hospital Mortality||Hospital discharge||||||
112940|NCT00709124|Secondary|ICU and Hospital Length of Stay||Hospital discharge||||||
112941|NCT00709124|Secondary|Duration of Mechanical Ventilation||At hospital discharge||||||
112942|NCT00709124|Secondary|Functional Status as Measured by Modified Functional Independence Measurement (FIM) Score Between Those Receiving NMES vs. Sham Sessions||ICU and hospital discharge||||||
112943|NCT00709124|Secondary|Respiratory Muscle Strength: Maximum Inspiratory Pressure (MIP) Between Those Who Receive NMES vs. Sham Sessions||ICU and hospital discharge||||||
112948|NCT00709111|Secondary|Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall|Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.|At weeks 4, 12, and 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.||doses missed||Full Range|Median
112949|NCT00709111|Secondary|Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)|A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.|At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36|As-treated: Participants who initiated treatment were included. Through week 24, follow-up while receiving MVC without change in background regimen were included. For week 36, only results obtained while receiving background regimen were included. One subject who had a large rise (blip) in viral load at week 24 was excluded.||proportion of participants|||Number
112950|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
112951|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||ng/ml||90% Confidence Interval|Median
112952|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||pg/ml||90% Confidence Interval|Median
112953|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||mg/dl||90% Confidence Interval|Median
112954|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
112955|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||ng/ml||90% Confidence Interval|Median
112956|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||pg/ml||90% Confidence Interval|Median
112957|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||mg/dl||90% Confidence Interval|Median
112958|NCT00709111|Secondary|Change in D-dimer|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||mcg/ml||90% Confidence Interval|Median
112959|NCT00709111|Secondary|Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||ng/ml||90% Confidence Interval|Median
112960|NCT00709111|Secondary|Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||pg/ml||90% Confidence Interval|Median
112961|NCT00709111|Secondary|Change in High Sensitivity C-reactive Protein (Hs-CRP)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||mg/dl||90% Confidence Interval|Median
113029|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
112963|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||mcg/ml||90% Confidence Interval|Median
112964|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||mcg/ml||90% Confidence Interval|Median
112965|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||% of CD8+ T-cells||90% Confidence Interval|Median
112966|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.||% of CD4+ T-cells||90% Confidence Interval|Median
112967|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||% of CD8+ T-cells||90% Confidence Interval|Median
112968|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.||% of CD4+ T-cells||90% Confidence Interval|Median
112969|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||% of CD8+ T-cells||90% Confidence Interval|Median
112970|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.||% of CD4+ T-cells||90% Confidence Interval|Median
112971|NCT00709111|Secondary|Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.|Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.|From baseline through week 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.||participants|||Number
112972|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4 percentage or a week 48 CD4 percentage obtained while receiving background regimen were included.||% of total lymphocytes||90% Confidence Interval|Median
112973|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4 percentage obtained while receiving background regimen were included.||% of total lymphocytes||90% Confidence Interval|Median
112988|NCT00709059|Primary|Number of Study Participants Who Had a Virological Response (VR) at Week-72|"VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.~Participants who dropped out or were withdrawn from treatment were considered not to respond."|Treatment Week 72|Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.||Participants|||Number
112989|NCT00708942|Secondary|Incidence of Patients With Adverse Events||3 months|All patients treated||percentage of no of patients analyzed|||Number
112974|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.||% of total lymphocytes/year||90% Confidence Interval|Mean
112975|NCT00709111|Secondary|Within-subject CD4 Percentage Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.||% of total lymphocytes/year||90% Confidence Interval|Mean
112976|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4 percentage or a week 24 CD4 percentage obtained while receiving MVC without change in background regimen were included.||% of total lymphocytes||90% Confidence Interval|Median
112977|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4+ T-cell count or a week 48 CD4+ T-cell count obtained while receiving background regimen were included.||cells/mm^3||90% Confidence Interval|Median
112978|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4+ T-cell count obtained while receiving background regimen were included.||cells/mm^3||90% Confidence Interval|Median
112979|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.||cells/mm^3/year||90% Confidence Interval|Mean
112980|NCT00709111|Secondary|Within-subject CD4+ T-cell Count Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.||cells/mm^3/year||90% Confidence Interval|Mean
112981|NCT00709111|Secondary|Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count|Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.||proportion of participants||90% Confidence Interval|Number
112982|NCT00709111|Primary|Change in CD4+ T-cell Count|Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.||cells/mm^3||90% Confidence Interval|Median
112983|NCT00709098|Other Pre-specified|Average Inhalation Time|Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)|12 weeks|All treated population||minutes||Standard Deviation|Mean
112984|NCT00709098|Primary|Patients With Adverse Events Leading to Premature Discontinuation of Study Drug|Number of patients with adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.|||participants|||Number
112985|NCT00709098|Primary|Adverse Events Leading to Premature Discontinuation of Study Drug|Number of adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.|Safety population||adverse events|||Number
112986|NCT00709098|Primary|Treatment-emergent Serious Adverse Events|Number of serious adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population||serious adverse events|||Number
112987|NCT00709098|Primary|Treatment-emergent Adverse Events|Number of adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population||adverse events|||Number
112990|NCT00708942|Secondary|Eradication of HPV|High risk HPV|6 months|Patients who were positive for high risk HPV at baseline||percentage of no. of patients analyzed|||Number
112993|NCT00708851|Secondary|The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.|Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.||participants|||Number
112994|NCT00708851|Primary|The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.|Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.||percent improvement from baseline||Full Range|Mean
112995|NCT00708526|Secondary|Return of Cognitive Function|average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth|up to 30 minutes|number of participants determined by protocol||minutes||Standard Deviation|Mean
112996|NCT00708526|Primary|Recovery From Anesthesia|average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).|up to 2 hours|||minutes||Standard Deviation|Mean
112997|NCT00708500|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.||At Follow-up Week 12 and at 72 weeks after randomization|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).||participants|||Number
112998|NCT00708500|Secondary|Number of Participants With Early Virologic Response.|Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.|At Week 2, 4, 8, or 12|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).||participants|||Number
112999|NCT00708500|Secondary|Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.|"SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.~This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009."|At Follow-up Week 24|mITT = all randomized subjects who received at least one dose of boceprevir (experimental arms) or boceprevir placebo (control arm).||Percentage of Participants|||Number
113000|NCT00708500|Primary|Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.|SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.|At Follow-up Week 24|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).||Percentage of Participants|||Number
113001|NCT00708461|Primary|Change in Body Mass Index (BMI)|Assessed in kilograms per meter squared.|Baseline to 24 months|Participants with complete data at baseline and two years, and those who were not pregnant at either time, were retained for analysis.||kilograms per meter squared||Standard Error|Least Squares Mean
113002|NCT00708435|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.|The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.||participants|||Number
113003|NCT00708435|Secondary|45-Day All-cause Mortality||Until Day 45|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||participants|||Number
113004|NCT00708435|Secondary|Use of Other Blood Products and Hemostatic Agents|Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||Units of blood products||Standard Deviation|Mean
113005|NCT00708435|Secondary|Transfusion of Red Blood Cells|Red blood cells were packed red blood cells (PRBCs).|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||Units of PRBCs||Standard Deviation|Mean
113030|NCT00708214|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
113006|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After Randomization|The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
113007|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants|||Number
113008|NCT00708435|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From preinfusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of normal||Standard Deviation|Mean
113009|NCT00708435|Secondary|Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex|The incremental IVR [(IU/dL)/(IU/kg)] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = [maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)]/{[exact dose of component in drug administered (IU)]/[body weight (kg)]}.|Before infusion and up to 3 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||(IU/dL)/(IU/kg body weight)||Standard Deviation|Mean
113010|NCT00708435|Secondary|Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 3 and 6 hours after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
113011|NCT00708435|Primary|Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)|A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after end of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
113012|NCT00708435|Primary|Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 1 and 4 hours after the end of infusion|The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.||percentage of participants||95% Confidence Interval|Number
113013|NCT00708422|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.||Units on a scale||Standard Deviation|Mean
113014|NCT00708422|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.||seconds||Standard Deviation|Mean
113058|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set||percentage of participants|||Number
113015|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 4 hours post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
113016|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 2 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
113017|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 1 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
113018|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 30 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
113019|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 15 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||μg*F/g||Full Range|Median
113020|NCT00708305|Secondary|Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||ln(μg*F*minutes/cm^2)||Standard Error|Log Mean
113021|NCT00708305|Primary|Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."||ln(μg*F*minutes/cm^2)||Standard Error|Least Squares Mean
113022|NCT00708214|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1|baseline till end of treatment|||participants|||Number
113023|NCT00708214|Secondary|Change From Baseline in Ca15.3|Change from baseline in Ca15.3 tumor marker levels|baseline and day 29|Analysis of all treatment arms combined for tumor marker analysis.||percentage of baseline level||Full Range|Median
113024|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.||hours||Full Range|Median
113025|NCT00708214|Secondary|Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
113026|NCT00708214|Secondary|Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
113031|NCT00708214|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
113032|NCT00708214|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death.|Baseline till progression, death or data cut-off|TS. Estimation of median time to death was not feasible, due to the small number of patients who died during the trial.||days||95% Confidence Interval|Median
113033|NCT00708214|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria.|Baseline till progression, death or data cut-off (04 Jan 2010)|TS||days||95% Confidence Interval|Median
113034|NCT00708214|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|First occurence or OR till progression or death|TS. Median duration of RECIST tumour response was not calculable as there was no OR observed.||days||95% Confidence Interval|Median
113035|NCT00708214|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|Baseline till progression|TS. Median time to RECIST tumour response was not calculable as there was no OR observed.||days||95% Confidence Interval|Median
113036|NCT00708214|Secondary|Number of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|16 weeks and 24 weeks|TS||Participants|||Number
113037|NCT00708214|Secondary|Number of Participants With Confirmed Objective Response (OR)|OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status.|Baseline till progression|TS||Participants|||Number
113038|NCT00708214|Primary|Percentage of Progression Free Participants After 16 Weeks of Treatment|Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.|16 weeks|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Percentage of participants||95% Confidence Interval|Number
113039|NCT00708201|Secondary|Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events|CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.|Baseline to 30 days post discharge|All participants who received at least 1 dose of study medication.||percentage of participants|||Number
113040|NCT00708201|Secondary|Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points|DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.||percentage of participants|||Number
113041|NCT00708201|Secondary|Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points|Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.||percentage of participants|||Number
113042|NCT00708201|Secondary|Percentage of Participants With Postoperative Morbidity (POM)|POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.|During hospitalization or within 7 days after discharge|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable POM data.||percentage of participants|||Number
113043|NCT00708201|Secondary|Percentage of Participants Considered Postoperative LOS Responders|A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.|Day of surgery (Day 0) up to 7 days after surgery|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.||percentage of participants|||Number
113044|NCT00708201|Secondary|Postoperative Length of Stay (LOS)|The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).|Day of surgery (Day 0) to the day of hospital DOW|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.||Days||Standard Deviation|Mean
113059|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set||percentage of participants|||Number
113045|NCT00708201|Secondary|Mean Time to Discharge Order Written (DOW) Using KM Estimates|"The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to DOW data. 36 participants in the Placebo group and 15 participants in the Alvimopan group were censored.||Hours||Standard Error|Mean
113046|NCT00708201|Secondary|Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model|"The endpoint of “time to ready for discharge” was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable ready to discharge data. 21 participants in the Placebo group and 12 participants in the Alvimopan group were censored.||Hours||Standard Error|Mean
113047|NCT00708201|Primary|Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model|"Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|From day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data. 39 participants in the Placebo group and 17 participants in the Alvimopan group were censored.||Hours||Standard Error|Mean
113048|NCT00708175|Other Pre-specified|Number of Participants With Fracture|Number of participants with confirmed (through an adjudication process) fractures during the study. Circumstances surrounding the fracture, available X-ray and other diagnostic results and healing status were collected for the adjudication process.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).||participants|||Number
113049|NCT00708175|Other Pre-specified|Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM)|Participants were considered to have converted to T2DM if there were ≥2 consecutive post-Baseline FPG measurements ≥126 mg/dL. Participants meeting criteria were tabulated and summarized by Study Period (Treatment and Follow-up). Conversion to T2DM during Treatment Period occurred if either both of the consecutive post-Baseline high FPG values, or the first of the 2 consecutive high values occurred on or before the first day off study drug. Conversion to T2DM occurred during the Follow-up Period if both consecutive high values occurred after at least 1 day after the Treatment Period.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).||participants|||Number
113050|NCT00708175|Other Pre-specified|Change in Fasting Plasma Glucose (FPG)|The change between the fasting plasma glucose value collected at each time frame indicated.|Baseline and Month 12; Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).||mg/dL||Standard Error|Least Squares Mean
113051|NCT00708175|Secondary|Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA|The change in bone mineral density in the total proximal femur at month 18 relative to month 12. DXA is a means of measuring BMD through x-ray.|Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data.||percent||Standard Error|Least Squares Mean
113052|NCT00708175|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)|The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 12.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data. If a valid pre-treatment scan was not available, the earliest (within 30 days) post-dosing scan was used as Baseline. There was one such participant for this endpoint.||percent||Standard Error|Least Squares Mean
113053|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 96|The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.||cells/mm^3||Standard Deviation|Mean
113054|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.||cells/mm^3||Standard Deviation|Mean
113055|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 96|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.||log10 copies/mL||Standard Deviation|Mean
113056|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.||log10 copies/mL||Standard Deviation|Mean
113057|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set||percentage of participants|||Number
113061|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
113062|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
113063|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
113064|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set||percentage of participants||95% Confidence Interval|Number
113065|NCT00708162|Secondary|Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 96|ITT Analysis Set||percentage of participants|||Number
113066|NCT00708162|Secondary|Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 48|ITT Analysis Set||percentage of participants|||Number
113067|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set||percentage of participants|||Number
113068|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set||percentage of participants|||Number
113069|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set||percentage of participants|||Number
113070|NCT00708162|Primary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set||percentage of participants|||Number
113071|NCT00708123|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."||µg*F/cm^2||Standard Error|Least Squares Mean
113072|NCT00708123|Secondary|Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."||%SMHR||Standard Error|Least Squares Mean
113073|NCT00708123|Primary|Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the n per treatment group."||%SMHR||Standard Error|Least Squares Mean
113074|NCT00708110|Secondary|Number of Participants With the Emergence of Drug Resistance Mutations|The number of participants with the emergence (from Baseline) of drug resistance mutations at Day 11 was measured.|Baseline and Day 11|ITT(E) Population||participants|||Number
113075|NCT00708110|Secondary|Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Day 11|Median change from Baseline in CD4+ cell count was calculated as the Day 11 value minus the Baseline value.|Baseline and Day 11|Per-Protocol Population: all participants included in the ITT(E) Population, excluding those who had at least one major protocol deviation||Cells per cubic millimeter (cells/mm^3)||Full Range|Median
113076|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population||Log10 copies/mL||Standard Deviation|Mean
113077|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population||Log10 copies/mL||Full Range|Median
113078|NCT00708110|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities|Clinical laboratory toxicities were graded according to the National Institutes of Allergy and Infectious Diseases (NIAID), Division of Acquired Immunodeficiency Syndrome (DAIDS). Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented only for Grade 3 and Grade 4 laboratory abnormalities. Clinical laboratory abnormalities included: increased glucose, lipase, decreased platelets, and triglycerides.|Screening; Days 1, 3, 7, and 10; and Follow-up (up to Study Day 21)|Safety Population||participants|||Number
113079|NCT00708110|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A 12-lead electrocardiogram (ECG) was performed by qualified personnel at the site after the participant had rested for at least 5 minutes in a semi-recumbent or supine position. If a QTc measurement of >=500 milliseconds (msec) was noted on a scheduled or unscheduled ECG, two additional ECGs were to be obtained within 5 minutes to confirm the abnormality. The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) ECG findings are presented here. The site determined if an ECG finding is significant or not. ECGs were obtained at Screening, Day 1 (pre-dose [twice] and then 1.0, 1.5, and 2.0 hours [hrs] post dose), Day 4 (pre-dose), Day 7 (pre-dose), Day 10 (pre-dose and then 1.0, 1.5, and 2.0 hrs post dose), Day 11 (prior to the 24 hr PK sample [pre lab]), and Follow-up.|Screening; Days 1, 7, 10, 11; and Follow-up (up to Study Day 21)|Safety Population. Only those participants who were available at the indicated time points were analyzed.||participants|||Number
113080|NCT00708110|Primary|Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10|Heart rate is the measure of heart beats per minute (bpm). Change in the mean heart rate from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population||beats per minute||Standard Deviation|Mean
113081|NCT00708110|Primary|Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10|Blood pressure measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Change in the mean blood pressure from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population||millimeters of mercury (mmHg)||Standard Deviation|Mean
113082|NCT00708110|Primary|Number of Participants Who Received the Indicated Concomitant Medications During the Study Period|Concomitant medications received during the study period are presented by generic term. Only those concomitant medications that were received by at least two participants are presented. “Multiple ingredient” is the term used in the statistical package for items that contain more than one active ingredient.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population. Only those participants who received a concomitant medication were analyzed.||participants|||Number
113083|NCT00708110|Primary|Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population: all participants who were randomized into the study with documented evidence of having received at least one dose of randomized treatment||participants|||Number
113084|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 10|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.||L/hr||Geometric Coefficient of Variation|Geometric Mean
113085|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following the Last Repeat Administration on Day 10|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analysed for the placebo group.||Hours||Geometric Coefficient of Variation|Geometric Mean
113086|NCT00708110|Primary|Time to the Maximum Observed Concentration (Tmax) of GSK1349572 Following the Last Repeat Administration on Day 10|tmax is defined as the time to the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 10|PKS Population. No participants were analyzed for the placebo group.||Hours||Full Range|Median
113834|NCT00703391|Primary|Aspartate Aminotransferase (AST)|AST level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
113087|NCT00708110|Primary|Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration|C0 is defined as the pre-dose concentration. Ctau is defined as the concentration at the end of the dosing interval. Cmin is defined as the minimum observed concentration during one dosing interval. Cmax is defined as the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
113088|NCT00708110|Primary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK1349572 Following the Last Repeat Administration on Day 10|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-tau) is defined as the area under the concentration-time curve over the dosing interval. Blood samples for PK analysis of GSK1349572 were obtained on Day 10at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
113089|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 1|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
113090|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following Dose Administration on Day 1|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.||Hours||Geometric Coefficient of Variation|Geometric Mean
113091|NCT00708110|Primary|Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1|tmax is defined as the time to the maximum obsevered plasma concentration. Absorption lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. tlag was estimated based on PK sampling times of 0 (pre-dose), 0.5, 1, 1.5, 2 3, 4, 6, 8, 12, and 24 hours post-dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed for the placebo group.||Hours||Full Range|Median
113092|NCT00708110|Primary|Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1|Cmax is defined as the maximum observed plasma concentration, and C24 is defined as the concentration at 24 hours post dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, Cmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed in the placebo group.||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
113093|NCT00708110|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to24 hours. Blood samples for pharmacokinetic (PK) analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|Pharmacokinetic Summary (PKS) Population: participants (par.) with an evaluable profile of GSK1349572 on Day 10. Par. were excluded if they vomited within 2 hours of dosing on Day 10, missed more than one dose 2 days prior to Day 10, and took prohibited concomitant medication during the treatment period. No par. were analyzed in the placebo group.||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
113094|NCT00708110|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL|The number of participants who achieved plasma HIV-1 RNA levels <400 copies/mL and <50 copies/mL through Day 11 was measured.|Day 11|ITT(E) Population||participants|||Number
113095|NCT00708110|Secondary|Plasma HIV-1 RNA Rate of Decline Over 10 Days|The rate of decline of plasma HIV-1 RNA levels from Day 1 to Day 11 was measured.|Day 1 to Day 11|ITT(E) Population||Log10 copies/mL/day||90% Confidence Interval|Mean
113096|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population||Log10 copies/mL||Full Range|Median
113097|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population||Log10 copies/mL||Standard Deviation|Mean
113098|NCT00708110|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11|Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) was calculated as the Day 11 value minus the Baseline value. Blood samples for the measurement of HIV-1 RNA levels were obtained throughout the treatment period (Day 1 to Day 11).|Baseline (Day 1) and Day 11|Intent to Treat Exposed (ITT[E]) Population: all participants who met study criteria and were randomized into the study with documented evidence of having received at least one dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement||Log10 copies/milliliter (log10 copies/mL||Standard Deviation|Mean
113099|NCT00708097|Secondary|Enamel Fluoride Uptake (Demineralized Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.||μg*F/cm^2||Standard Error|Least Squares Mean
113100|NCT00708097|Secondary|Enamel Fluoride Uptake (Sound Enamel Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Least Squares Mean
113101|NCT00708097|Secondary|Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.||Percentage SMHR||Standard Error|Least Squares Mean
113102|NCT00708097|Secondary|Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.||Percentage SMHR||Standard Error|Least Squares Mean
113103|NCT00708097|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.||Percentage SMHR||Standard Error|Least Squares Mean
113104|NCT00708071|Primary|Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period||Through Postoperative Day 14 (± 1)|Safety Data Set||Adverse Events|||Number
113105|NCT00708071|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)|Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol||participants|||Number
113106|NCT00708071|Secondary|Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol||Scores on a scale||Full Range|Median
113107|NCT00708071|Secondary|Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol||Scores on a scale||Full Range|Median
113108|NCT00708071|Secondary|Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14|Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points|Postoperative Days 3, 7, 10, and 14|Per protocol||mm||Full Range|Median
113113|NCT00708071|Secondary|Resolution of Ecchymosis as Assessed by Investigators|Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol||participants|||Number
113114|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113115|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113116|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113117|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113118|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113119|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol||Scores on a scale||90% Confidence Interval|Median
123895|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
113120|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113121|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113122|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113123|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113124|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113125|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4.~Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113126|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3|"Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Postoperative Day 3|Per Protocol||Scores on a scale||Full Range|Median
113133|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 14|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 14|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
113127|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113128|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113129|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113130|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113131|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113132|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol||Scores on a scale||90% Confidence Interval|Median
113253|NCT00707239|Other Pre-specified|Time to Reach Maximum Observed Serum Concentration (Tmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hrs||Full Range|Median
113134|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 10|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 10|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
113135|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 7|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 7|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
113136|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 5|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 5|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
113137|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 1|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 1|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
113138|NCT00708071|Primary|Visual Comparison of Ecchymosis at Postoperative Day 3|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 3|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.||participants|||Number
113139|NCT00708032|Primary|Papillary Conjunctivitis|Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.|12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
113140|NCT00708032|Secondary|Subjective Overall Vision After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
113141|NCT00708032|Secondary|Subjective Overall Comfort After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
113142|NCT00708032|Secondary|Visual Acuity After 12 Months of Wear|Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||logMar||Standard Deviation|Mean
113143|NCT00708032|Secondary|Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.|Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Mean
113144|NCT00708019|Secondary|Worst Pain Intensity Score|"Worst pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in worst pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks|||units on a scale||95% Confidence Interval|Mean
113145|NCT00708019|Primary|Average Pain Intensity Score|"Average pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks|||units on a scale||95% Confidence Interval|Mean
113146|NCT00707993|Secondary|Incidence of Glycosylated Hemoglobin Decrease From Baseline.|The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||percentage of participants|||Number
113147|NCT00707993|Secondary|Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%|The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||percentage of participants|||Number
113148|NCT00707993|Secondary|Change From Baseline in High Sensitivity C-reactive Protein|The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/L||Standard Error|Least Squares Mean
113149|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Triglycerides)|The change in triglycerides measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
123896|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL/hr||Standard Deviation|Mean
113150|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)|The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
113151|NCT00707993|Secondary|Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)|The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
113152|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Total Cholesterol)|The change in total cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
113153|NCT00707993|Secondary|Change From Baseline in Body Weight|The change in body weight measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||kg||Standard Error|Least Squares Mean
113154|NCT00707993|Secondary|Homeostasis Model Assessment of Beta Cell Function|The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||percent score of beta cell function||Standard Error|Least Squares Mean
113155|NCT00707993|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||ratio||Standard Error|Least Squares Mean
113156|NCT00707993|Secondary|Change From Baseline in Insulin|The change between the value of insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mcIU/mL||Standard Error|Least Squares Mean
113157|NCT00707993|Secondary|Change From Baseline in Fasting Proinsulin|The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||pmol/L||Standard Error|Least Squares Mean
113158|NCT00707993|Secondary|Change From Baseline in 2-hour Postprandial Glucose|The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set).||mg/dL||Standard Error|Least Squares Mean
113159|NCT00707993|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
113160|NCT00707993|Secondary|Incidence of Hyperglycemic Rescue|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis.||participants|||Number
113161|NCT00707993|Secondary|Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).|The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set).||participants|||Number
113162|NCT00707993|Secondary|Incidence of Hypoglycemia|Percentage of participants with at least one hypoglycemic episode during 52 week study.|On occurrence (up to 52 weeks).|Percentages based on the number of Safety Set participants in each treatment group.||percentage of participants|||Number
113163|NCT00707993|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
113164|NCT00707993|Primary|Change From Baseline in Glycosylated Hemoglobin at Week 52.|The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
113254|NCT00707239|Other Pre-specified|Maximum Observed Serum Concentration (Cmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
113165|NCT00707980|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 52|Safety set with available data||participants|||Number
113166|NCT00707980|Secondary|Change From Baseline to the Final Visit in the Sheehan Disability Scale|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.||scores on a scale||Standard Deviation|Mean
113167|NCT00707980|Secondary|Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst).|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.||scores on a scale||Standard Deviation|Mean
113168|NCT00707980|Secondary|Change From Baseline in the Clinical Global Impression of Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
113169|NCT00707980|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
113170|NCT00707980|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
113171|NCT00707980|Secondary|Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Deviation|Mean
113172|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.|Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52|Safety set||participants|||Number
113173|NCT00707980|Primary|Number of Participants With Adverse Events (AEs)|"The intensity (severity) of each AE was defined as:~Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.~Moderate: sufficiently uncomfortable to produce some impairment of normal activities.~Severe: incapacitating, preventing the patient from participating in normal activities.~The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion."|From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)|Safety set||participants|||Number
113174|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.|Weeks 4, 12, 24, 36 and 52|Safety set||participants|||Number
113175|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|Safety set||participants|||Number
113176|NCT00707980|Primary|Physical Examination Findings|"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.~Each system was assessed as normal or abnormal."|Baseline and Week 52|The safety set included all participants who enrolled and received at least 1 dose of open-label study medication. Results include data for participants with available data at each time point; 834 participants at Baseline and 524 participants at Week 52.||participants|||Number
113177|NCT00707967|Secondary|Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes|Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.|From Day 60 to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113178|NCT00707967|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
113179|NCT00707967|Secondary|Cell Count of CD4+ T Cells|CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.|At Day 0, 30, 60 and 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||T cells/cubic millimeter||Inter-Quartile Range|Median
113180|NCT00707967|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.~For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
113181|NCT00707967|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
113182|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113183|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113184|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113185|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113186|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113397|NCT00706563|Primary|Number of Serconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|At Day 21|||subjects|||Number
113187|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113188|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113189|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113190|NCT00707967|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113191|NCT00707967|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity|During the entire study period, from Day 0 up to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113192|NCT00707967|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113193|NCT00707967|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113194|NCT00707967|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
113195|NCT00707954|Secondary|Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin||18 days||||||
113196|NCT00707954|Secondary|Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr||19 days||||||
113197|NCT00707954|Primary|Safety: Adverse Events, Adverse Drug Reactions|In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.|19 days|||percentage of incidences|||Number
113198|NCT00707915|Secondary|Clinical Global Impression (CGI)|The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8.|Week 8|||units on a scale||Standard Deviation|Mean
113199|NCT00707915|Secondary|Leeds Sleep Evaluation Questionnaire (LSEQ)|The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8.|Week 8|||units on a scale||Standard Deviation|Mean
113200|NCT00707915|Secondary|Critical Flicker Fusion Test (CFF)|The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded.|Baseline and week 8|||Hz||Standard Deviation|Mean
113201|NCT00707915|Secondary|Clinical Stabilometric Platform (CSP)|CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded.|Baseline and week 8|||cm||Standard Deviation|Mean
113202|NCT00707915|Secondary|A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8.|This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure.|Baseline and week 8|||units on a scale||Standard Deviation|Mean
113203|NCT00707915|Primary|Completion Rate|The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects|8 weeks|||percentage of successful completers|||Number
113204|NCT00707863|Primary|17-item Hamilton Depression Rating Scale (HAM-D)|Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
113205|NCT00707759|Secondary|Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy||12 months||||||
113206|NCT00707759|Primary|Stimulation of Growth After 12 Months (Delta Z-score)||12 months|||units on a scale||Standard Deviation|Mean
113207|NCT00707746|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113208|NCT00707746|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113209|NCT00707746|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113210|NCT00707746|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113211|NCT00707746|Other Pre-specified|Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||ratio||Standard Deviation|Mean
113212|NCT00707746|Other Pre-specified|Percent Change From Baseline in the Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113213|NCT00707746|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113214|NCT00707746|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113398|NCT00706563|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|At Day 0 and 21|||subjects|||Number
153935|NCT00352053|Secondary|Change From Baseline to Week 192 in HIV-1 RNA||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
113215|NCT00707746|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113216|NCT00707746|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113217|NCT00707746|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113218|NCT00707746|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113219|NCT00707746|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113220|NCT00707746|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113221|NCT00707746|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113222|NCT00707746|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113223|NCT00707746|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Inter-Quartile Range|Median
113224|NCT00707746|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Inter-Quartile Range|Median
113225|NCT00707746|Primary|Summary of Participants With Adverse Events|"The on-treatment time frame spanned the time during which the study drug was administered until the later of the primary efficacy time point and 14 days beyond the last study drug date.~Adverse events (AEs) were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug.~Severity was assessed as:~Mild-symptom barely noticeable to the patient or do not make the patient uncomfortable;~Moderate-symptom makes the patient uncomfortable, affects performance of daily activities;~Severe-symptom causes the patient severe discomfort, may cause cessation of treatment with the study drug.~Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Pre-treatment (prior to first dose), On-treatment (Day 1 to week 28), Post-treatment (Week 28-52)|Safety set of all randomized participants who received at least one injection of study drug.||participants|||Number
113226|NCT00707746|Primary|Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set||mg/dL||Standard Deviation|Mean
113227|NCT00707746|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of baseline||Standard Deviation|Mean
113228|NCT00707655|Secondary|Tumor Response Rate/ Complete or Partial Response||2 years|||participants|||Number
113229|NCT00707655|Secondary|Best Overall Tumour Response|Best overall tumor response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|2 years|||participants|||Number
113230|NCT00707655|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.|Overall study|||participants|||Number
113231|NCT00707486|Secondary|Incidence of Post Surgical Sequelae||1 week post surgery|||Percent of Participants|||Number
113232|NCT00707486|Primary|Time to Hemostasis|This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.|Minutes After Application|Participants served as their own control thus the total amount of participants is reflected in both of the outcome measures.||Minutes|Participants|Standard Error|Mean
113233|NCT00707447|Secondary|Emotional Well-being/ Depression (CES-D)|"The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items scored from 0 to 3. Scores are summated, with raw score ranging from 0 to 25. Higher Scores idicate a higher depressive state.~Mean change in depression score (CES-D) after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
113234|NCT00707447|Secondary|Psychological Well-being (WHO-5)|"The WHO (Five) Well-being index consists of 5 items on the overall well-being over the last two weeks. Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4, with higher scores meaning better well-being.~Mean change in psychological well-being score (WHO-5) after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
113235|NCT00707447|Secondary|Eating Behavior (TFEQ) - Hunger|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale hunger consists of 14 Item with a minimum score of 0 and a maximum score of 14. Low scores indicate an eating behavior strongly depending on feelings of hunger.~Mean change in the TFEQ - hunger scale after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
113236|NCT00707447|Secondary|Eating Behavior (TFEQ) - Disinhibition|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale disinhibition consists of 16 Item with a minimum score of 0 and a maximum score of 16. High scores indicate an uninhibited eating behavior strongly depending on external cues.~Mean change in the TFEQ - disinhibition scale after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
113237|NCT00707447|Secondary|Eating Behavior (TFEQ) - Cognitive Restraint|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale cognitive restraint consists of 21 Item with a minimum score of 0 and a maximum score of 21. Low scores indicate an uninhibited eating behavior.~Mean change in the TFEQ - cognitive restraint scale after 12 months"|12 months|||units on a scale||Standard Deviation|Mean
113238|NCT00707447|Secondary|Physical Exercise|Mean changes in physical exercise (in min/week) after 12 months|12 months|||minutes per week||Standard Deviation|Mean
113239|NCT00707447|Secondary|Glucose Tolerance|Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months|12 months|||mg/dl||Standard Deviation|Mean
113240|NCT00707447|Secondary|Fasting Glucose|Mean changes in fasting glucose (in mg/dl) after 12 month|12 months|||mg/dl||Standard Deviation|Mean
113241|NCT00707447|Primary|Waist Circumference|Mean change in waist circumference (in cm) after 12 months|12 months|||cm||Standard Deviation|Mean
113242|NCT00707447|Primary|Weight Change|Mean weight change (in kg) after 12 months|12 month|Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures||kg||Standard Deviation|Mean
113255|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Potentially clinically significant ECG data: Non-first values greater than 240 millisecond (msec) with increase of greater than or equal to 10 percent (%) from baseline for PR interval; Non-first values greater than or equal to 120 msec for QRS interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for corrected QT (QTc) interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for QTc using Framingham formula (QTc F).|Baseline up to Day 14 or LDOT|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
113399|NCT00706563|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|At Day 0 and 21|||subjects|||Number
113243|NCT00707343|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques|"The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis.~Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVmean of a 1 cm diameter region of normal contralateral white matter was also measured (F-18 FDG ratio lesion: contralateral white matter). For F-18 FLT, the maximum standardized uptake value (SUVmax) was measured at suspicious area of lesion enhancement. Patlak graphical analysis was applied using the metabolite-corrected plasma input function to obtain voxel-wise estimates of the FLT metabolic influx parameter (F-18 FLT Kimax)."|30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation|||Probability||95% Confidence Interval|Number
113244|NCT00707239|Other Pre-specified|Duration of Intravenous Antibiotic Treatment, Hospital and Intensive Care Unit (ICU) Stay||Baseline up to Day 44 (30 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable for intravenous antibiotic treatment, hospital or ICU stay for each reporting group respectively.||days||Full Range|Median
113245|NCT00707239|Other Pre-specified|Time to Reach Half of the Maximum Observed Plasma Concentration and Time to Normalization of Concentrations (Tnorm) of Procalcitonin||Baseline up to Day 6|Data was not analyzed because there was no apparent change in procalcitonin concentration over time.||hr||Full Range|Median
113246|NCT00707239|Other Pre-specified|Maximum Observed Plasma Concentration of Procalcitonin (Cmaxpd) and Predicted Procalcitonin Plasma Concentration at 24 Hours (Cpd,24) and 48 Hours (Cpd,48)||Baseline up to Day 6|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
113247|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Microbiological Outcome|Microbiological response:Eradication=baseline isolate not present in repeat culture from original infection site;Presumed Eradication=clinical response of cure precluded availability of specimen for culture;Persistence=baseline isolate present in repeat culture from original infection site;Presumed Persistence=culture data not available for participants with clinical response of failure;Superinfection=culture from primary infection site had new pathogen not identified as baseline isolate, clinical response was failure. MIC=lowest drug concentration with no visible growth of microorganism.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Data was not analyzed because correlation analysis could not be performed due to insufficient number of participants for whom data for both microbiological outcomes and tigecycline concentration was available.||ratio||Standard Deviation|Mean
113248|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Clinical Outcome|Clinical response:Cure =Initial SSx improved;CXR improved/stable;no other antibiotic for pneumonia;no worsening/new SSx. Failure=Persistence/worsening SSx;no clinical improvement/initial improvement with worsening; other antibiotic;CXR progression;death >study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reason;death in 2 days after dose 1 for any reason or >2 days but before TOC visit for non-pneumonia reason. MIC=lowest drug concentration with no visible growth of microorganism. AUC(0-24)/MIC:reported for cure and failure/indeterminate.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
113249|NCT00707239|Other Pre-specified|Correlation of AUC (0-24) of Tigecycline With Nausea and Vomiting|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population PK analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Baseline up to Day 29 to 35 (15 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg*hr/mL||Standard Deviation|Mean
113250|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Tigecycline|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mg*hr/mL||Standard Deviation|Mean
113251|NCT00707239|Other Pre-specified|Clearance (CL) of Tigecycline|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of serum from which drug can be completely removed per unit of time.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter/hr||95% Confidence Interval|Mean
113252|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Tigecycline|AUC (0-12) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
113400|NCT00706563|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|At Day 0 and 21|||titer||95% Confidence Interval|Geometric Mean
113256|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Laboratory Examinations|Participants were evaluated for following laboratory parameters: albumin, alkaline phosphatase, amylase, urea (blood urea nitrogen [BUN]), total bilirubin, calcium, magnesium, carbon dioxide, international normalized ratio (INR), chloride, creatinine, glucose, lipase, potassium, phosphorus, aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, total protein, hemoglobin, hematocrit, white blood cells, eosinophils, neutrophils, lymphocytes, platelets, prothrombin time, prothrombin activity and partial thromboplastin time.|Baseline up to Day 24 to Day 35 (10 to 21 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
113257|NCT00707239|Other Pre-specified|Number of Participants Who Experienced Nausea or Vomiting||Baseline up to Day 29 to Day 35 (15 to 21 days after LDOT)|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
113258|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Participant Level Population at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure precluded the availability of a specimen for culture; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure; Superinfection = culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|Up to Day 24 to 35 (10 to 21 days after LDOT)|ME population included participants who met specified evaluability criteria for efficacy, had culture taken from the infected site before first dose of study medication and had at least 1 pathogen, and at least 1 baseline pathogen was susceptible to tigecycline and imipenem/cilastatin regimens.||percentage of participants|||Number
113259|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Pathogen Level Population at Test-of-Cure (TOC) Visit|Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for participants with a clinical response of failure; Indeterminate=unable to determine outcome for non-study drug/infection reasons; no baseline isolate; death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Microbiologically Evaluable (ME) population:participants who met evaluability criteria for efficacy, had culture taken from infected site before dose 1 of study drug, had at least (>=)1 pathogen, >=1 pathogen was susceptible to tigecycline, imipenem/cilastatin regimen; ‘n’ = those participants who had specified pathogen for each group respectively.||percentage of participants|||Number
113260|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. 'n' is signifying those participants who were evaluable for this measure and included in VAP (suffering from VAP) and non-VAP group (not suffering from VAP) for each group respectively.||percentage of participants|||Number
113261|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|c-mITT population included all participants who were randomly assigned to receive intravenous study medication and had clinical evidence of hospital-acquired pneumonia (HAP).||percentage of participants|||Number
113262|NCT00707239|Primary|Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR) improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT])|CE population included those participants who met specified evaluability criteria for efficacy.||percentage of participants|||Number
113263|NCT00707174|Primary|The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants|Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.|24 months|All evaluable patients from both groups were compared||participants|||Number
113264|NCT00707161|Primary|Response Rate of Melanoma Lesions|Response rate of melanoma lesions was measured after treated with the trial agent.|2005-2010|Study terminated. Analysis not conducted.|||||
113284|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
113265|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 4|"Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 48 hours or at time of rescue between 36 and 48 hours.|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
113266|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 3|"Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 36 hours or at time rescue between 24 and 36 hours|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
113267|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 2|"Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 24 hours or at time of rescue between 12 and 24 hours|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
113268|NCT00707057|Secondary|Global Evaluation for Dose 1|"Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command:~“Select the number that best describes how you would rate this medication as a pain-reliever (select one number only).” The range went from 0 (Very poor) to 10 (Excellent)."|At 12 hours after Dose 1 or at time of rescue|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
113269|NCT00707057|Secondary|Pain Relief and PID Scores at Individual Time Points for Dose 1|Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement)|24, 36, 48 hours after taking Dose 1|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
113270|NCT00707057|Secondary|Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1|Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.|0-12 hours after taking Dose 1|Intention to treat (ITT)||Percentage of participants||95% Confidence Interval|Least Squares Mean
113271|NCT00707057|Secondary|Duration of Relief After Dose 1|Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time.|Time to rescue or time of Dose 2 (up to 12 hours following dose 1)|Intention to treat (ITT)||Minutes||Full Range|Median
113272|NCT00707057|Secondary|Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID)|The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived.|0-12 hours after Dose 1|Intention to treat (ITT)||Time weighted units on a scale||Standard Deviation|Mean
113273|NCT00707057|Secondary|"Percentage of Subjects Achieving Meaningful Relief as Indicated by the Time Recorded on the Second Stopwatch Following First Perceptible Relief"|"Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both first perceptible relief and meaningful relief within the time allotted. The assigned censored time for No Pain Relief is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain"|Within 4 hours post Dose 1|Intention to treat (ITT)||Percent of participants||95% Confidence Interval|Number
113274|NCT00707057|Secondary|Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1|"Percentage (percentage of total) of subjects with first perceptible relief within 1 hour of Dose 1. The assigned censored time for No Pain Relief was 240 minutes."|Within 1 hour of Dose 1|Intention to treat (ITT)||Percent of participants||95% Confidence Interval|Number
113275|NCT00707057|Secondary|"Time to Confirmed Meaningful Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed meaningful relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both initial and meaningful relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain."|Within 4 hours post Dose 1|Intention to treat (ITT)||Minutes||Full Range|Median
153936|NCT00352053|Secondary|Change From Baseline to Week 144 in HIV-1 RNA||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
113276|NCT00707057|Secondary|"Time to Confirmed First Perceptible Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for No Pain Relief is 240 minutes."|Within 4 hours post Dose 1|Intention to treat (ITT)||Minutes||Full Range|Median
113277|NCT00707057|Primary|Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours|Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation.|24, 36, and 48 hours|Intention to treat (ITT)||participants|||Number
113278|NCT00707057|Primary|Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale|"Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID).~An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation."|from baseline to 12 hours after dose 1|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
113279|NCT00707031|Other Pre-specified|Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) at Week 24|PAGI-QOL: a 30–item self-administered questionnaire to measure health related QOL of patients with upper gastrointestinal disorders during past 2 weeks. Consists of 5 sub-scales. Each item rated on a 0-5 point Likert scale (0 [none of the time] to 5 [all the time]). Sub-scale score calculated by dividing sum of all items of subscale by number of items in the sub-scale. Total score calculated by taking mean of sub-scale scores. Sub-scale score and total score ranges from 0=none of the time (lowest score) to 5=all of the time (highest score) with lower scores indicating better QOL. The on-treatment period for this variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PAGI-QOL assessment during on-treatment period.||units on a scale||Standard Error|Least Squares Mean
113280|NCT00707031|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from hypoglycemia in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks|Safety population included all randomized patients who received at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
113281|NCT00707031|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
113282|NCT00707031|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.||percentage of participants|||Number
113283|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
113311|NCT00706849|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
113285|NCT00707031|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
113286|NCT00707031|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
113287|NCT00707031|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute Change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
113288|NCT00706992|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years|||Participants|||Number
113289|NCT00706992|Primary|Percentage of Participants With Immunologic Response|Percentage of participants with an immunologic response of >20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.|9/24/08-10/9/12|Arms 1-6 were evaluated in patients who received F5 cells. Arm 7 was not included in the evaluation because the participants did not receive F5 cells.The immunological response was measured for the total percentage of pts whom specimen was available for analysis. This was not captured per Arm. No statistically significant responses were observed.||Percentage of participants|||Number
113290|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At 6-month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
113291|NCT00706979|Primary|A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|Serious quit attempt of >=24hrs, which fits the CDC’s definition of a quit attempt.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
113292|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At any point during the study|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
113293|NCT00706979|Primary|A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.||participants|||Number
113294|NCT00706966|Secondary|Testosterone Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.||ng/dL||Standard Deviation|Mean
113295|NCT00706966|Secondary|Dihydrotestosterone (DHT) Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.||ng/dL||Standard Deviation|Mean
113296|NCT00706966|Secondary|Total PSA Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 for the 6-month Mean(SD) levels.||ng/mL||Standard Deviation|Mean
113297|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - SQLI|The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to 6 months; thus, n=9 at 6 months.||units on a scale||Standard Deviation|Mean
113298|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - FACE|Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.||units on a scale||Standard Deviation|Mean
113365|NCT00706654|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
113299|NCT00706966|Secondary|Symptom Indices Over Time - IIEF-5|The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.||units on a scale||Standard Deviation|Mean
113300|NCT00706966|Secondary|Symptom Indices Over Time - IPSS|IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).|Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.||units on a scale||Standard Deviation|Mean
113301|NCT00706966|Secondary|Adverse Events Indicative of Safety of Dutasteride|Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.|Baseline, 1, 3, and 6 months|||adverse events|||Number
113302|NCT00706966|Primary|Change in Extent of Cancer|Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.|1 month, 6 months|One participant withdrew from the study||participants|||Number
113303|NCT00706901|Secondary|Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Days of drug use||Standard Deviation|Mean
113304|NCT00706901|Primary|Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Number of 12-step sessions attended||Standard Deviation|Mean
113305|NCT00706901|Primary|Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Number of treatment sessions||Standard Deviation|Mean
113306|NCT00706901|Primary|Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)||Standard alcohol drinks||Standard Deviation|Mean
113307|NCT00706901|Primary|Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)||Days of binge drinking||Standard Deviation|Mean
113308|NCT00706901|Primary|Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)||Days Using Alcohol||Standard Deviation|Mean
113309|NCT00706849|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
113310|NCT00706849|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
113312|NCT00706849|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
113313|NCT00706849|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||ratio||Inter-Quartile Range|Median
113314|NCT00706849|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
113315|NCT00706849|Other Pre-specified|Very Low Density Lipoprotein at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
113316|NCT00706849|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
113317|NCT00706849|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
113318|NCT00706849|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
113319|NCT00706849|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Inter-Quartile Range|Median
113320|NCT00706849|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Inter-Quartile Range|Median
113321|NCT00706849|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
113322|NCT00706849|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
113323|NCT00706849|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
113324|NCT00706849|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
113325|NCT00706849|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
113326|NCT00706849|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||percentage of baseline||Standard Deviation|Mean
113327|NCT00706849|Primary|LDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set||mg/dL||Standard Deviation|Mean
113328|NCT00706849|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.||percentage of Baseline||Standard Deviation|Mean
113329|NCT00706836|Secondary|To Evaluate the Effects of an Anxiolytic Drug Versus Placebo on Eye Blink Startle Response at Rest and During Emotional Stimuli (Anxiety Potentiated Startle, APS) as Well as on Clinical Scales.||Week 1, 2, 3||||||
113330|NCT00706836|Primary|Effect of Pregabalin (Two Doses) Versus Placebo|Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.|Week 1, 2, 3 (Cross-over Design)|Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order.||% signal change L amygdala + anticipn||Standard Error|Mean
113331|NCT00706823|Secondary|Number of Attempts|The number of attempts taken to place the device|Before intubation|||participants|||Number
113332|NCT00706823|Secondary|Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization|When the fiberoptic scope was placed in the gastirc drain tube of the i-gel, if the esophageal mucosa was visible and the stomach was readily accessible, then placement was considered succussful.|after intubation|Only the -gel has a gastric drainage tube--the uLMA does not. Thus, only those receiving the i-gel were assessed for this measure.||participants|||Number
113333|NCT00706823|Primary|Leak Pressure|After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.|duration of intubation|||cm of H2O||Standard Deviation|Mean
113334|NCT00706823|Secondary|Number of Participants With Oropharyngeal Discomfort|Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.|post operative, immediately and 24 hrs after intubation|||participants|||Number
113335|NCT00706823|Secondary|Level of Difficulty for Intubation|Ease of SGA insertion and intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = very easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = very difficult).|duration of intubation|||participants|||Number
113336|NCT00706823|Primary|Time Required for Intubation|The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).|duration of intubation|||seconds||Standard Deviation|Mean
113337|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on scale||Standard Deviation|Mean
113338|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health Index|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on scale||Standard Deviation|Mean
113339|NCT00706797|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)|Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113340|NCT00706797|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)|Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 12, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113382|NCT00706628|Secondary|Duration of RECIST Response|"Time from first observation of response (PR, CR, confirmed or unconfirmed) until progression according to RECIST (version 1.0) or death.~Duration is expressed in Median number of days."|Up to 48 weeks|FAS (RECIST evaluable set)||days||Inter-Quartile Range|Median
113341|NCT00706797|Secondary|Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period|Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||mg||Standard Deviation|Mean
113342|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 90% (ACR90) Response|American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113343|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|American College of Rheumatology 70% (ACR70) response: responder = ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113344|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|American College of Rheumatology 50% (ACR50) response: responder = ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113345|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|American College of Rheumatology 20% (ACR20) response: responder = ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113346|NCT00706797|Secondary|Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria|Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113347|NCT00706797|Secondary|Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant’s assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission. DAS28 response of >0.6 defined as decrease in DAS28 >0.6 (change in DAS28 < -0.6).|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113348|NCT00706797|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113349|NCT00706797|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.60)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113364|NCT00706706|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.||Weeks||95% Confidence Interval|Median
113350|NCT00706797|Secondary|Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.1=higher disease activity; <3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (change in DAS28 < -1.2).|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants|||Number
113351|NCT00706797|Secondary|Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52|Radiographic non-progression determined based on TSS change <0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52, Last observation carried forward (LOCF)|mITT; efficacy data not analyzed due to early termination of the study.||percentage of participants||95% Confidence Interval|Number
113352|NCT00706797|Secondary|Change From Baseline in Joint Space Narrowing at Week 52|Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on a scale||Standard Deviation|Mean
113353|NCT00706797|Secondary|Change From Baseline in Erosions at Week 52|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.||scores on a scale||Standard Deviation|Mean
113354|NCT00706797|Primary|Change From Baseline in Modified Total Sharp Score (TSS) at Week 52|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|Modified intent-to-treat (mITT) population including all participants with an erosion at randomization confirmed by the blinded expert assessor, received at least 1 dose of subject treatment, and had data for randomization and 1 post randomization X-ray. Efficacy data not analyzed due to early termination of the study.||scores on a scale||Standard Deviation|Mean
113355|NCT00706784|Primary|Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion||8 hours|||pg/ml||Standard Deviation|Mean
113356|NCT00706719|Secondary|Follicle Stimulating Hormone (FSH) Levels|FSH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||mIU/mL||Standard Deviation|Mean
113357|NCT00706719|Secondary|Luteinizing Hormone (LH) Levels|LH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||mIU/mL||Standard Deviation|Mean
113358|NCT00706719|Primary|Semen Volume|Semen volume was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||mL||Standard Deviation|Mean
113359|NCT00706719|Primary|Motile Total Sperm Count|Motile total sperm count was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||millions sperm||Standard Deviation|Mean
113360|NCT00706719|Primary|Sperm Concentration|Total sperm concentration was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.||millions sperm/mL||Standard Deviation|Mean
113361|NCT00706706|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)|Safety population included those participants who had taken at least one dose of the study drug.||Percent chance of survival||95% Confidence Interval|Number
113362|NCT00706706|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.||Weeks||95% Confidence Interval|Median
113363|NCT00706706|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Per protocol (PP) population included those participants who had the disease under study, measurable disease and an adequate baseline disease assessment and had taken at least one dose of the study drug.||Percentage of participants||95% Confidence Interval|Number
113366|NCT00706654|Secondary|Percentage of Responders up to Week 38|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
113367|NCT00706654|Secondary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse||Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.||Days||95% Confidence Interval|Median
113368|NCT00706654|Primary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26|A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline to Week 26|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
113369|NCT00706641|Secondary|Increase in Cas3 Expression|Cas3 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients||participants|||Number
113370|NCT00706641|Secondary|Reduced Ki-67 Expression|Ki-67 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients||participants|||Number
113371|NCT00706641|Secondary|Post-Cystectomy Pathologic Stage|Tumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M) T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed M0=No distant metastases, M1=Distant metastases present|Staged Post-Cystectomy and dasatinib treatment|||percentage of particpants||95% Confidence Interval|Number
113372|NCT00706641|Secondary|Pathologic Complete Response (pCR) Rate|Pathologic complete response (pCR) rate is defined as no residual evidence of muscle-invasive disease at cystectomy (< pT0).|24 months|23 participants completed treatment and underwent radical cystectomy.||participants|||Number
113373|NCT00706641|Secondary|Reduced pSFK Expression|pSFK levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients||participants|||Number
113374|NCT00706641|Secondary|Grade 3/4 Toxicities|Report grade 3/4 toxicities during treatment with dasatinib prior to radical cystectomy in patients with muscle invasive transitional cell carcinoma of the bladder.|Time of consent through 30 days after treatment discontinuation|24 patients received treatment, 1 patient ineligible due to small cell histology after starting dasatinib treatment and was not evaluable.||percentage of particpants|||Number
113375|NCT00706641|Primary|Feasibility|Feasibility for this trial is defined as at least 60% (>=14 of 23) of patients completing study therapy in the absence of Dose Limiting Toxicity (DLT)|From enrollment to completion of radical cystectomy|All patients who completed dasatinib||participants|||Number
113376|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy|"Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment (C12,14 for BIBF1120 ; C24,7 and C24,14 for BIBW2992)~C12,14: plasma concentration at 12 hours Day 14"|Day7, Day 14|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
113377|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy|Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment|Day 15, Day 29 and Day 57|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
113378|NCT00706628|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set||percentage of participants|||Number
113379|NCT00706628|Secondary|Incidence and Worst Intensity of Adverse Events With Grading According CTCAE|Incidence and worst intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set||percentage of participants|||Number
113380|NCT00706628|Secondary|Overall Survival (Time to Death)|Overall survival (time to death) was calculated in days from baseline to the date of reporting of death. Time is expressed in Median number of days.|start of treatment until 28 days after end of treatment (Up to 52 weeks)|FAS||days||95% Confidence Interval|Median
113381|NCT00706628|Secondary|Time to Progression|"Time from first administration of study drug until disease progression according to composite endpoint.~Time is expressed in Median number of days."|start of treatment until end of the treatment (Up to 48 weeks)|FAS||days||95% Confidence Interval|Median
113396|NCT00706563|Primary|Serconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|At Day 21|||factor|||Number
113383|NCT00706628|Secondary|Overall Objective Response by RECIST Criteria (Version 1.0) (Complete Response [CR] or Partial Response [PR]) for Patients With Measurable Disease at 12, 24, 36 and 48 Weeks|Objective response is defined as a Complete or Partial response Complete response [CR] for Target lesions: Disappearance of all target lesions. Complete response [CR] for Non- target lesions: Disappearance of all non-target lesions and normalization of tumour marker level Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|12, 24, 36 and 48 weeks|FAS (RECIST evaluable set)||percentage of participants|||Number
113384|NCT00706628|Secondary|RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks|RECIST (version 1.0) tumour progression rate at 12, 24, 36, and 48 weeks was calculated based on the occurrence of new lesions, or an increase in the sum of the longest lesion diameters of at least 20%.|12, 24, 36, and 48 weeks|FAS (RECIST evaluable set); RECIST evaluable set, which consisted of patients who had RECIST measurable disease at baseline.||percentage of participants|||Number
113385|NCT00706628|Secondary|Time to PSA Progression|"Time to PSA progression through 48 weeks was calculated as the number of days from first administration of study drug to the first time that there was an increase of 50% from the PSA nadir, provided the absolute increase was at least 5 ng/mL.~Time is expressed in median number of days."|Start of treatment until end of treatment (Up to 48 weeks)|FAS||days||95% Confidence Interval|Median
113386|NCT00706628|Secondary|Duration of PSA Response|"Duration of PSA response was calculated from the time of first 50% decline in PSA (compared to baseline) until the time at which there was an increase of 50% from the PSA nadir, provided that the absolute increase was at least 5 ng/mL. The increase had to be confirmed by a second consecutive measurement that was at least 50% above the nadir. If the PSA never showed a 50% increase over the nadir value, then the patient was censored at the last PSA measurement.~Duration of PSA response expressed in median number of days."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS||days||Inter-Quartile Range|Median
113387|NCT00706628|Secondary|Number of Patients Showing Prostate Serum Antigen (PSA) Response|"PSA response was evaluated according to the PSAWG guidelines. All patients achieving a fall in PSA of ≥50% from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria for PSA response. The confirmatory value had to be at least 50% lower than the baseline value, but could be higher than the original drop in PSA (first PSA value).~However, the confirmatory value could not be 50% higher than the first PSA value. If it was ≥50% higher than the first PSA, another sample was taken to determine if response had been achieved."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS||percentage of participants|||Number
113388|NCT00706628|Secondary|Progression Free Rate at 24 and 48 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to RECIST version 1.0"|24 weeks and 48 weeks|"Full analysis set (FAS), which consisted of all patients who received at least~1 dose of study medication and for whom progression status could be determined at 12 weeks."||percentage of participants||95% Confidence Interval|Number
113389|NCT00706628|Primary|Progression Free Rate (PFR) at 12 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0"|12 weeks|Modified full analysis set(mFAS): Patients who received at least 1 dose of study medication and for whom progression status could be determined at 12 weeks,excluding patients who discontinued treatment before 12 weeks for reasons other than PD.||percentage of participants||95% Confidence Interval|Number
113390|NCT00706589|Primary|Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)|The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.|10 week|ITT (Intention-To-Treat)analysis||units on a scale||Full Range|Mean
113391|NCT00706589|Secondary|1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.||10 weeks||||||
113392|NCT00706563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
113393|NCT00706563|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period|||subjects|||Number
113394|NCT00706563|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.~Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever"|During the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
113395|NCT00706563|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects unprotected at pre-vaccination and with available results||subjects|||Number
123897|NCT00608491|Secondary|Change in Blood N- Terminal Pro- BNP||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
113401|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.|One-month post-vaccine|||Titers||Full Range|Geometric Mean
113402|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.|Baseline|||Titers||Full Range|Geometric Mean
113403|NCT00706550|Primary|IgM Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine|||Micrograms/ml||Full Range|Geometric Mean
113404|NCT00706550|Primary|Immunoglobulin M (IgM) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline|||Micrograms/ml||Full Range|Geometric Mean
113405|NCT00706550|Primary|IgG Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine|||Micrograms/ml||Full Range|Geometric Mean
113406|NCT00706550|Primary|Immunoglobulin G (IgG) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline|||Micrograms/ml||Full Range|Geometric Mean
113407|NCT00706485|Secondary|Marginal Failure.|Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.|up to 10 years|Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.|||||
113408|NCT00706485|Secondary|Number of Participants With Local Control|Local failure is defined as: extension of the tumor margin[s] in any direction at least 5 mm beyond that present on the pre-treatment imaging studies or the appearance of -tumor in tissues previously scored as sites of sub-clinical disease. Local control is absence of local failure.|at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10|||participants|||Number
113409|NCT00706485|Primary|Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use||At time of procedure|||participants|||Number
113410|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 10 (6 Weeks after Final PDT)|ITT observed||particpants|||Number
113411|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 9 (3 Weeks after Final PDT)|ITT observed||participants|||Number
113412|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 7 (Week 9)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 7 (Week 9)|ITT observed||participants|||Number
113413|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 5 (Week 6)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 5 (Week 6)|ITT observed||participant|||Number
113414|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 3 (Week 3)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 3 (Week 3)|ITT observed||participants|||Number
113645|NCT00705289|Primary|Baseline Raw DAS28 by Country of Residence|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.|At Baseline|||Score on a scale||Standard Deviation|Mean
113415|NCT00706433|Secondary|Oozing/Vesiculation/Crusting 48 Hours After PDT #1|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|48 hours after PDT #1|ITT observed||participants|||Number
113416|NCT00706433|Secondary|Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 10 (6 Weeks after Final PDT)|ITT observed||participants|||Number
113417|NCT00706433|Secondary|Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 9 (3 Weeks after Final PDT)|ITT observed||participants|||Number
113418|NCT00706433|Secondary|Scaling and Dryness at Visit 7 (Week 9)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 7 (Week 9)|ITT observed||participants|||Number
113419|NCT00706433|Secondary|Scaling and Dryness at Visit 5 (Week 6)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 5 (Week 6)|ITT observed||participants|||Number
113420|NCT00706433|Secondary|Scaling and Dryness at Visit 3 (Week 3)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 3 (Week 3)|ITT observed||participants|||Number
113421|NCT00706433|Secondary|Scaling and Dryness 48 Hours After PDT #1|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|48 hours after PDT #1|ITT observed||participants|||Number
113422|NCT00706433|Secondary|Stinging/Burning at Visit 10 (6 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 10 (6 Weeks after Final PDT)|ITT observed||participants|||Number
113423|NCT00706433|Secondary|Stinging/Burning at Visit 9 (3 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 9 (3 Weeks after Final PDT)|ITT observed||participants|||Number
113424|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - post light treatment)|ITT observed||participants|||Number
113425|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - during light treatment)|ITT observed||participants|||Number
113426|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - prior to light treatment)|ITT observed||participants|||Number
113427|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - before study drug application)|ITT observed||participants|||Number
113428|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - post light treatment)|ITT observed||participants|||Number
113429|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - during light treatment)|ITT observed||participants|||Number
113681|NCT00704938|Primary|Clinical Response (Complete Response + Partial Response)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.|5 months|||Participants|||Number
113430|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - prior to light treatment)|ITT observed||participants|||Number
113431|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - before study drug application)|ITT observed||participants|||Number
113432|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - post light treatment)|ITT observed||participants|||Number
113433|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - during light treatment)|ITT observed||participants|||Number
113434|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before light treatment)|ITT observed||participants|||Number
113435|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before study drug application)|ITT observed||participants|||Number
113436|NCT00706433|Secondary|Stinging/Burning 48 Hours Post PDT #1|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|48 hours post PDT #1|ITT observed||participants|||Number
113437|NCT00706433|Secondary|Stinging/Burning at Baseline - Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - post light treatment|ITT observed||participants|||Number
113438|NCT00706433|Secondary|Stinging/Burning at Baseline - During Light|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - during light|ITT observed||participants|||Number
113439|NCT00706433|Secondary|Stinging/Burning at Baseline - Before Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - before light treatment|ITT observed||participants|||Number
113440|NCT00706433|Secondary|Edema 6 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|6 weeks after final PDT|ITT observed||participants|||Number
113441|NCT00706433|Secondary|Edema 3 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|3 weeks after final PDT|ITT observed||participants|||Number
113442|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - post light treatment)|ITT observed||participants|||Number
113443|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Prior to Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - prior to light treatment)|ITT observed||participants|||Number
113444|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - before study drug application)|ITT observed||participants|||Number
113445|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - post light treatment)|ITT observed||participants|||Number
113485|NCT00706433|Primary|Investigator Global Assessment of Acne Severity Successes|Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.|Baseline and 3 weeks after final treatment|ITT LOCF||participants|||Number
113446|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Pre Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - pre light treatment)|ITT observed||participants|||Number
113447|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - before study drug application)|ITT observed||participants|||Number
113448|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - post light treatment)|ITT observed||participants|||Number
113449|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before light treatment)|ITT observed||participants|||Number
113450|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before study drug application)|ITT observed||participants|||Number
113451|NCT00706433|Secondary|Edema 48 Hours After PDT #1|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|48 hours after PDT #1|ITT observed||participants|||Number
113452|NCT00706433|Secondary|Edema at Baseline - Post Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - Post Light Treatment|ITT observed||participants|||Number
113453|NCT00706433|Secondary|Edema at Baseline - Pre Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - pre light treatment|ITT observed||participants|||Number
113454|NCT00706433|Secondary|Erythema 6 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|6 Weeks after Final PDT|ITT observed||participants|||Number
113455|NCT00706433|Secondary|Erythema 3 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|3 Weeks after Final PDT|ITT observed||participants|||Number
113456|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - post light treatment)|ITT, observed||participant|||Number
113457|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Pre Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - pre light treatment)|ITT observed||participants|||Number
113458|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - prior to study drug application)|ITT observed||participants|||Number
113682|NCT00704912|Secondary|Prevalence of Metabolic Syndrome||Baseline, 4 months|||participants|||Number
113459|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - post light treatment)|ITT, observed||participants|||Number
113460|NCT00706433|Secondary|Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Weeks 6 - pre-light treatment)|ITT, observed||participants|||Number
113461|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - prior to study drug application)|ITT, observed||participants|||Number
113462|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - post light treatment)|ITT, observed||participants|||Number
113463|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre-light)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre-light)|ITT, observed||participants|||Number
113464|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre study drug application)|ITT, observed||participants|||Number
113465|NCT00706433|Secondary|Erythema 48 Hours After PDT #1|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|48 hours after PDT #1|ITT, observed||participants|||Number
113466|NCT00706433|Secondary|Erythema at Baseline - Post Light Treatment|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline - post light treatment|ITT observed||participants|||Number
113467|NCT00706433|Secondary|Erythema at Baseline (Pre-light)|"After solution application, prior to light treatment~﻿ Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema"|Baseline (pre-light)|ITT, observed||participants|||Number
113468|NCT00706433|Secondary|Hypopigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed||participants|||Number
113469|NCT00706433|Secondary|Hypopigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed||participants|||Number
113486|NCT00706433|Primary|Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT analysis, LOCF||change in lesion count||Standard Deviation|Median
113683|NCT00704912|Secondary|Change in Weight|Change from baseline to end of the 4-month intervention.|Baseline, 4 months|||kg||95% Confidence Interval|Least Squares Mean
113470|NCT00706433|Secondary|Hypopigmentation at Visit 7 (Week 9)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed||participants|||Number
113471|NCT00706433|Secondary|Hypopigmentation at Visit 5 (Week 6)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed||participants|||Number
113472|NCT00706433|Secondary|Hypopigmentation at Visit 3 (Week 3)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed||participants|||Number
113473|NCT00706433|Secondary|Hypopigmentation 48 Hours Post PDT #1|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|48 hours post PDT #1|ITT, observed||participants|||Number
113474|NCT00706433|Secondary|Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed||participants|||Number
113475|NCT00706433|Secondary|Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed||participants|||Number
113476|NCT00706433|Secondary|Hyperpigmentation at Visit 7 (Week 9)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed||participant|||Number
113477|NCT00706433|Secondary|Hyperpigmentation at Visit 5 (Week 6)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed||participants|||Number
113478|NCT00706433|Secondary|Hyperpigmentation at Visit 3 (Week 3)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed||participants|||Number
113479|NCT00706433|Secondary|Hyperpigmentation 48 Hours After PDT #1|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|48 hours after PDT #1|ITT, observed||participants|||Number
113480|NCT00706433|Secondary|Investigator Global Assessment of Acne Severity Successes|"Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.~﻿0 Clear skin with no inflam or non-inflam lesions~Almost clear; rare non-inflam lesions with no more than a few small inflam lesions~Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)~Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule~Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules"|Baesline and 6 weeks after final treatment|ITT LOCF||participants|||Number
113481|NCT00706433|Secondary|Change in Inflammatory Lesion Counts Relative to Baseline|change in lesion counts compared to baseline|Baseline and 6 weeks after final treatment|ITT LOCF||change in lesion count||Standard Deviation|Median
113482|NCT00706433|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|6 weeks after final treatment|ITT, observed||participants|||Number
113483|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 6 weeks after final treatment|ITT LOCF||percent change in lesion count||Standard Deviation|Median
113484|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT LOCF||percent change in lesion count||Standard Deviation|Median
113684|NCT00704912|Secondary|Ovulation Rate||Up to 4 months|||total number of ovulations|Clomiphene Treatment Cycles||Number
113487|NCT00706355|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression up to C2 D1|Efficacy analysis set included all enrolled participants who received the study treatment and had measurable disease at baseline.||Percentage of participants||95% Confidence Interval|Number
113488|NCT00706355|Secondary|Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3’-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2|F-fluoro-3'-deoxy-3’-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts. Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN).|Cycle 2 Day 1|Data was not analyzed due to insufficient number of participants enrolled.||Standardized Uptake Value (SUV)||Standard Deviation|Mean
113489|NCT00706355|Secondary|Apparent Oral Clearance (CL/F) for PF-04217903|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Liter/hr (L/hr)||Standard Deviation|Geometric Mean
113490|NCT00706355|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||Ratio||Standard Deviation|Mean
113491|NCT00706355|Secondary|Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1). Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||Ratio||Standard Deviation|Mean
113492|NCT00706355|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||ng*hr/mL||Standard Deviation|Geometric Mean
113493|NCT00706355|Secondary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||ng*hr/mL||Standard Deviation|Geometric Mean
113494|NCT00706355|Secondary|Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluable for this measure.||ng/mL||Standard Deviation|Geometric Mean
113495|NCT00706355|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||hr||Full Range|Median
113496|NCT00706355|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||ng/mL||Standard Deviation|Geometric Mean
113497|NCT00706355|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1|The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.||Nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
113498|NCT00706355|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events.|Baseline up to 21 days after the start of each increased treatment dose|DLT analysis set: participants who received first cycle of study medication and did not temporarily or permanently discontinue from study medication or missed more than 3 consecutive days of PF-04217903 dosing for reasons other than DLTs within first cycle.||Participants|||Number
113499|NCT00706355|Primary|Recommended Phase 2 Dose (RP2D)||Baseline up to 21 days after the start of each increased treatment dose|Data was not analyzed due to insufficient number of participants enrolled.||mg|||Number
113500|NCT00706355|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.|Baseline up to 21 days after the start of each increased treatment dose|Analysis population included all enrolled participants who received at least 1 dose of the study treatment.||mg|||Number
113501|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24||24 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
113502|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12||12 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
113503|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24||24 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
113504|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12||12 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
113505|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6||6 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
113506|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2||2 weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.||Participants|||Number
113507|NCT00706329|Secondary|At Follow up if the Hernia Has Not Closed, Another Surgery May be Required to Close the Umbilical Hernia.||Seven or more months after initial surgery.||||||
113508|NCT00706329|Primary|Close Belly Button or Umbilical Hernia|The study was terminated prematurely by the IRB. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.|After surgery, subjects will be followed at intervals of one month and six months from date of surgery.||||||
113509|NCT00706134|Secondary|Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.|Baseline to end of study (week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||mmHg||Standard Error|Least Squares Mean
113510|NCT00706134|Secondary|Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||Ratio||Standard Error|Least Squares Mean
113511|NCT00706134|Secondary|Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||mmHg||Standard Error|Mean
113512|NCT00706134|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Response|Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.|Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.||Percentage of participants|||Number
113513|NCT00706134|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
113514|NCT00706134|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.||mmHg||Standard Error|Least Squares Mean
113515|NCT00706095|Primary|Best Overall Response Per Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|throughout the study and up to 30 days after the last dose of study drug|ITT Population||Number of Participants|||Number
113516|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Maximum Observed Plasma Concentration (Cmax)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population||ng/mL||Standard Deviation|Mean
113517|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population||ng*hr/mL||Standard Deviation|Mean
113518|NCT00706004|Secondary|Serum Albumin||baseline and 4 weeks|Participants who completed the study||g/dL||Standard Deviation|Mean
113519|NCT00706004|Secondary|Serum Prealbumin||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
113520|NCT00706004|Secondary|Serum Vitamin E||baseline and 4 weeks|Participants who completed the study||mg/L||Standard Deviation|Mean
113521|NCT00706004|Secondary|Serum Vitamin A||baseline and 4 weeks|Participants who completed the study||ug/dL||Standard Deviation|Mean
113522|NCT00706004|Secondary|Serum Vitamin D||baseline and 4 weeks|Participants who completed the study||ng/mL||Standard Deviation|Mean
113523|NCT00706004|Secondary|Serum Glucose||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
113524|NCT00706004|Secondary|Serum Phosphate||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
113525|NCT00706004|Secondary|Serum Magnesium||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
113526|NCT00706004|Secondary|Serum Calcium||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
113527|NCT00706004|Secondary|ALT||baseline and 4 weeks|Participants who completed the study||U/L||Standard Deviation|Mean
113528|NCT00706004|Secondary|AST||baseline and 4 weeks|Participants who completed the study||U/L||Standard Deviation|Mean
113529|NCT00706004|Secondary|Serum Creatinine||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
113530|NCT00706004|Secondary|Serum BUN||baseline and 4 weeks|Participants who completed the study||mg/dL||Standard Deviation|Mean
113531|NCT00706004|Secondary|Serum Bicarb||baseline and 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
113532|NCT00706004|Secondary|Serum Potassium||baseline and 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
113533|NCT00706004|Secondary|Serum Chloride||baseline and 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
113534|NCT00706004|Secondary|Serum Sodium||baseline, 4 weeks|Participants who completed the study||nmol/L||Standard Deviation|Mean
113535|NCT00706004|Secondary|Self Reported Adverse Effects at Each Study Visit|Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.|During entire study period|Participants who completed the study||participants|||Number
113536|NCT00706004|Secondary|Body Mass Index||baseline, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study||kg/m^2||Standard Deviation|Mean
113537|NCT00706004|Secondary|Bristol Stool Scale Score|The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study||scores on a scale||Standard Deviation|Mean
113538|NCT00706004|Secondary|Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation – Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient’s assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4).|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study||scores on a scale||Standard Deviation|Mean
113539|NCT00706004|Primary|Number of Spontaneous Bowel Movements Per Week||2-week run-in period, 2-weeks of treatment, 4-weeks of treatment|Participants who completed the study||bowel movements||Standard Deviation|Mean
113540|NCT00705939|Secondary|Platelet Count||Platelet count at Baseline and Months 12, 24 and 36|||Platelets per cubic millimeter||Standard Deviation|Mean
113541|NCT00705939|Secondary|Hemoglobin||Hemoglobin at Baseline and Months 12, 24 and 36|||mg/dL||Standard Deviation|Mean
113542|NCT00705939|Other Pre-specified|Liver Volume Multiples of Normal (MN)|Liver volume measured by MRI. Normal liver volume is 25 mL/kg × body weight (kg).|Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI.||Multiples of Normal Liver Volume||Standard Deviation|Mean
113543|NCT00705939|Other Pre-specified|Spleen Volume Multiples of Normal (MN)|Spleen volume measured by MRI. Normal spleen volume is 2 mL/kg × body weight (kg)|Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.||Multiples of Normal Spleen Volume||Standard Deviation|Mean
113544|NCT00705939|Secondary|Liver Volume|Liver volume measured by MRI|Liver volume at Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI .||mL||Standard Deviation|Mean
113545|NCT00705939|Primary|Spleen Volume|Spleen volume measured by MRI|Spleen Volume at Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.||mL||Standard Deviation|Mean
113546|NCT00705874|Secondary|Pharmacokinetics||End of Study||||||
113547|NCT00705874|Secondary|Drug Safety||Ongoing||||||
113548|NCT00705874|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).~DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:~Any nonhematologic toxicity > Grade 3 lasting > 3 days~Grade 4 thrombocytopenia~Grade 4 Anemia on the next scheduled dosing day~Grade 4 Neutropenia (lasting > than 5 days~Any febrile neutropenia (Grade 3 or 4))~Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity"|End of Study|Cohorts comprised 3 patients. When a patient experienced a treatment related toxicity qualifying as a DLT, up to 3 additional patients were to be enrolled at that dose. Patients who completed cycle 1 per protocol were evaluable.||mg|||Number
113549|NCT00705783|Secondary|Time to Discontinuation|Time to discontinuation was defined as the date of randomization to the date of study discontinuation.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.||Days||95% Confidence Interval|Median
113550|NCT00705783|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient’s condition at Baseline. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-I scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Deviation|Mean
113551|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Negative Subscale Score|The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Least Squares Mean
113552|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Positive Subscale Score|The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Least Squares Mean
113553|NCT00705783|Secondary|Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score|The severity of illness for each patient was rated using the CGI-S. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-S scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Mean
113554|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Total Score|The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS total scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.||Units on a scale||Standard Error|Least Squares Mean
113555|NCT00705783|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who stayed in Phase 4 for at least 6 months and had values for the specific PANSS items P1, G9, P3, P2,G5, N1, N4, and N6.||Percentage of patients|||Number
113685|NCT00704912|Primary|Live Birth Rate||Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.|||participants|||Number
113556|NCT00705783|Secondary|Percentage of Responders|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat (ITT) population: All randomized patients. Two of the 269 patients in the ITT population did not attend the Last Visit at which this Outcome Measure was assessed and were not included in the analysis.||Percentage of patients|||Number
113557|NCT00705783|Secondary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria|This is the key secondary Outcome Measure.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.||Percentage of patients|||Number
113558|NCT00705783|Primary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse|A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.||Days||95% Confidence Interval|Median
113559|NCT00705757|Primary|The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.|"Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity.~Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement."|one year|Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.||L*a*b*||Standard Error|Mean
113560|NCT00705718|Secondary|Secondary Endpoint - Effectiveness Evaluation|"The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System.~Stent Graft migration through 12 months~Stent Graft Patency through 12 months~All stent Graft Endoleaks at 1-month, 6-months, and 12-month~Secondary Procedures to correct Type I and type III Endoleaks through 12 months~Secondary Endovascular Procedures through 12 months~Technical Observations through 12 months"|12 months|Number of subjects enrolled in the study arm||percentage of evaluable subjects|||Number
113561|NCT00705718|Primary|Primary Effectiveness Endpoint (Treatment Success)|"Treatment success is defined as Technical success and the following:~Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month~Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months~Freedom from aneurysm rupture through 12 months~Freedom from conversion to surgery through 12 months~Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months~Freedom from stent graft occlusion at 12 months"|12 months|The number of evaluable subjects for ths endpoint.||participants|||Number
113562|NCT00705718|Primary|Primary Effectiveness Endpoint (Technical Success)|Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.|Intra-operatively|The Technical Success of the Endurant Bifurcated arm was based on obtaining information for the first 121 evaluable subjects available in the clinical study.||participants|||Number
113563|NCT00705718|Secondary|Secondary Endpoints - Safety Evaluation|"The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System.~Aneurysm-Related Mortality through 12 months~All-Cause Mortality with 30 days~All-Cause Mortality within 12 months~Major Adverse Events through 12 months~Adverse Events through 12 months~Unanticipated Adverse Device Events~Serious Adverse Events (SAEs) As reported at the time of the data cut off.~Device Related Adverse Events~Procedure Related Adverse Events~Adverse Events (excluding SAEs)"|12 months|Number of subjects enrolled in the study arm||percentage of evaluable participants|||Number
113564|NCT00705718|Primary|Major Adverse Events Within 30 Days of Index Procedure|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days|||percentage of participants|||Number
113576|NCT00705679|Primary|Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||person-years|||Number
113565|NCT00705718|Primary|Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days (Safety)|Freedom from Major Adverse Events within 30 Days of Implant||percentage of participants|||Number
113566|NCT00705679|Primary|Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events|This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.|Throughout study, up to 2.5 years|All participants randomized (intention-to-treat).||participants|||Number
113567|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||cases per 100 person-years||95% Confidence Interval|Number
113568|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||participants|||Number
113569|NCT00705679|Primary|Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||person-years|||Number
113570|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||cases per 100 person-years||95% Confidence Interval|Number
113571|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||participants|||Number
113572|NCT00705679|Primary|Person-years of Follow-up of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||person-years|||Number
113573|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||cases per 100 person-years||95% Confidence Interval|Number
113574|NCT00705679|Secondary|Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product|The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.|Throughout study, up to 2.5 years|Resistance testing was successfully completed on plasma from 301/312 HIV-1 seroconverters while on study product. 11 participants did not have a resistance result due to no stored plasma, insufficient copies of HIV-1 RNA for extraction, or PCR amplification failure.||participants|||Number
113575|NCT00705679|Primary|Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.||participants|||Number
113797|NCT00703729|Primary|Patient Reported Pain on Day 6|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113577|NCT00705666|Primary|The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).||Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.|For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated).||Participants|||Number
113578|NCT00705653|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT).~Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047."|The MTD had to occur during cycle 1 of treatment|||mg|||Number
113579|NCT00705653|Secondary|Preliminary Efficacy|As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.|Patients with non-missing overall response||percentage (of participants)|||Number
113580|NCT00705614|Secondary|Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months|The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Surgical Procedures|||Number
113581|NCT00705614|Secondary|Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Days||Standard Deviation|Mean
113582|NCT00705614|Secondary|Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Hospital Stays||Standard Deviation|Mean
113583|NCT00705614|Secondary|Number of Participants With a Draining Fistula By Study Visit|The number of participants with a draining fistula was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113584|NCT00705614|Secondary|Work/Daily Activity Status Score By Study Visit|The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.|Up to 5 Years|The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Score on a Scale||Standard Deviation|Mean
113585|NCT00705614|Secondary|The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit|The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.|Up to 5 Years|The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Score on a Scale||Standard Deviation|Mean
113586|NCT00705614|Secondary|Participant Assessment of Overall Health Status By Study Visit|The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.|Up to 5 Years|The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Score on a Scale||Standard Deviation|Mean
113587|NCT00705614|Primary|Number of Participants With Lymphoproliferative Disorders/Malignancies|The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113588|NCT00705614|Primary|Number of Participants With Hematologic Conditions|The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113589|NCT00705614|Primary|Number of Participants With Demyelinating Neurological Disorders|The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113590|NCT00705614|Primary|Number of Participants With New or Worsening Congestive Heart Failure|The number of participants with new or worsening congestive heart failure was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113591|NCT00705614|Primary|Number of Participant Fatalities|The number of participant fatalities was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113592|NCT00705614|Primary|Number of Participants With Infusion-Related Reactions/Hypersensitivity|The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113593|NCT00705614|Primary|Number of Participants With Serious Infections|The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.||Participants|||Number
113594|NCT00705575|Secondary|Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.||Percentage|||Number
113595|NCT00705575|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
113596|NCT00705575|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 8|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 measurement or last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
113597|NCT00705575|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to end of study (Week 12)|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 12 measurement or last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
113822|NCT00703391|Secondary|Quantitative Sputum Bacteriology|Number of patients with an increase in bacteriological count from Day -1 to Day 15|Pre-dose day -1 to post-dose on day 15|||Participants|||Number
113598|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}])|The area under glucose infusion rate curve from minutes (min) 0 to 360 after injection (AUC[GIR{0-360}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 360 during the clamp. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[360]) data.||Grams per kilogram||Standard Deviation|Mean
113599|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}])|The area the glucose infusion rate curve from minutes (min) 0 to 240 after injection (AUC[GIR{0-240}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 240 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose up to 240 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[240]) data.||Grams per kilogram||Standard Deviation|Mean
113600|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 180 after injection (AUC[GIR{0-180}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 180 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 180 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[180]) data.||Grams per kilogram||Standard Deviation|Mean
113601|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}])|The area under the glucose infusion rate curve from minutes 0 to 120 after injection (AUC[GIR{0-120}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 120 during the clamp. Means were calculated using analysis of variance with fixed effects of participant, sequence within participant, treatment, and period.|Predose and up to 120 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-120]) data.||Grams per kilogram||Standard Deviation|Mean
113602|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 60 after injection (AUC[GIR{0-60}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment and every 3 min from min 0 through 60 during the clamp procedure. Means were calculated using analysis of variance with fixed of participant, sequence within participant, treatment, and period.|Predose and up to 60 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-60]) data.||Grams per kilogram||Standard Deviation|Mean
113603|NCT00705536|Secondary|Maximum Glucose Infusion Rate (GIR[Max])|Maximum glucose infusion rate (GIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable GIR(max) data.||Milligrams per kilogram per minute||Standard Deviation|Mean
113604|NCT00705536|Primary|Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone)|"Relative bioavailability was determined by dividing the baseline-corrected geometric mean of the area under the curve (AUC) for insulin (ins) (Humalog or Humulin-R) with recombinant human hyaluronidase PH20 (rHuPH20) by the baseline-corrected geometric mean of the AUC for insulin alone (AUC[insulin+rHuPH20]/AUC[insulin]).~Bioavailability values for participants who received Humalog or Humulin-R and rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog + rHuPH20 or Humulin-R + rHuPH20 with evaluable relative bioavailability (AUC[insulin+rHuPH20]/AUC[insulin alone]) data.||Ratio of AUC(ins+rHuPH20)/AUC(ins alone)||Standard Deviation|Mean
113643|NCT00705341|Primary|Methacholine Challenge Test Result for Phase 2|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks|weeks 0, 4|There was a significant period effect in the percentage change in post diluent baseline (PC20) for high- and low-dose depending upon the order in which the doses were administered. In order to remove the effect of the order, we compared the high- and low-dose MCT results exclusively during the first cross over.||mg/ml||Full Range|Geometric Mean
113605|NCT00705536|Primary|Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20])|Area under the concentration-time curve from time 0 to time to reach maximum concentration (tmax) for serum insulin (Humalog or Humulin-R) with recombinant human hyaluronidase (rHuPH20) (AUC[0-tmaxPH20]) for participants who received Humalog or Humulin-R and with rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment and every 3 min from min 0 through 48 for Stage 1 and, and every 3 min from min 0 through 68 for Stage 2 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 48 minutes postdose during Stage 1, or up to 68 minutes postdose during Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-tmaxPH20) data.||Picomoles per liter times minutes||Standard Deviation|Mean
113606|NCT00705536|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t'])|Area under the serum concentration-time curve from time zero to the time required to reach endogenous plasma glucose levels (AUC[0-t']) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-t') data.||Picomoles per liter times minutes||Standard Deviation|Mean
113607|NCT00705536|Secondary|Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%])|"Time to late half-maximal effect for glucose infusion rate (tGIR[late50%]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.~Because the study was only 360 minutes in duration, there was not sufficient time for regular human insulin to show an effect and therefore tGIR(late50%) could not be calculated for participants receiving Humulin-R alone."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, or Humulin-R + rHuPH20 with evaluable tGIR(late50%) data.||Minutes||Standard Deviation|Mean
113608|NCT00705536|Secondary|Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%])|Time to early half-maximal effect for glucose infusion rate (tGIR[early50%]) for participants who were randomized to Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(early50%) data.||Minutes||Standard Deviation|Mean
113609|NCT00705536|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Time to maximal effect for glucose infusion rate (tGIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained every 3 minutes during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(max) data.||Minutes||Standard Deviation|Mean
113610|NCT00705536|Primary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable Cmax data.||Picomoles per liter||Standard Deviation|Mean
113611|NCT00705536|Primary|Time to Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (tmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tmax data.||Minutes||Standard Deviation|Mean
113646|NCT00705289|Primary|Baseline Raw DAS28 by Gender|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.||Score on a scale||Standard Deviation|Mean
113612|NCT00705523|Secondary|Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.|The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.|12 weeks of treatment, with a follow-up one month after treatment|||alcohol composite score||Standard Deviation|Mean
113613|NCT00705523|Primary|Rate of Heavy Drinking Days Per Week.|Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).|12 weeks of treatment and one month follow-up|||rate of heavy drinking days per week||Standard Deviation|Median
113614|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR|"Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 4, 8, 12, 16, 20|Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.||Participants|||Number
113615|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)|"Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 2, 4, 8, 12, 16, or 20|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).||Participants|||Number
113616|NCT00705432|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL."|At FW 12 and at 72 weeks after randomization|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).||Participants|||Number
113617|NCT00705432|Secondary|Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR."|At FW 24|Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.||Percentage of participants|||Number
113618|NCT00705432|Primary|Sustained Virologic Response (SVR) Rate|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR."|At Follow-up Week (FW) 24|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).||Percentage of participants|||Number
113619|NCT00705406|Other Pre-specified|Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).||Fold Change from Baseline||Standard Error|Mean
113620|NCT00705406|Other Pre-specified|Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number of participants who had baseline susceptibility values to zanamivir, oseltamivir, and peramivir.||nM||Standard Error|Mean
113647|NCT00705289|Primary|Baseline Raw DAS28 by Time Since Diagnosis|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.|At Baseline|||Score on a scale||Standard Deviation|Mean
113823|NCT00703391|Secondary|AZD9668 Sputum Concentrations||Pre-dose day -1 to post-dose on day 14|||nM||Full Range|Geometric Mean
113621|NCT00705406|Other Pre-specified|Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N is for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).||Fold Change from Baseline||Standard Error|Mean
113622|NCT00705406|Other Pre-specified|Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.|Baseline|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N was 113 for zanamivir susceptibility in the Placebo group.||nM||Standard Error|Mean
113623|NCT00705406|Other Pre-specified|Incidence of Influenza-related Complications|Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.|14 days|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||participants|||Number
113624|NCT00705406|Other Pre-specified|Time to Resolution of Fever|Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||hours||95% Confidence Interval|Median
113625|NCT00705406|Other Pre-specified|Subject’s Severity of Illness (Score*Hours)|"A subject’s severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized.~The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21."|Information collected predose on Day 1 and then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||score*hours||Full Range|Median
113626|NCT00705406|Secondary|Change in Influenza Virus Shedding|Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).|Baseline and Days 3, 4, 9|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.||log10(TCID50/mL)||95% Confidence Interval|Median
113627|NCT00705406|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected with Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A by culture or PCR.||hours||95% Confidence Interval|Median
113628|NCT00705367|Secondary|Long-term Period: Number of Participants With Abatacept-specific Antibodies|Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.|Day15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of abatacept and had an immunogenicity test result.||Participants|||Number
113629|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3X*ULN, or if preRX>ULN, use >4*preRX; GGT (/L): >*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; BUN (mg/dL):>2*preRX; sodium: <.95*LLN, >1.05*ULN, <.95* preRX if <LLN preRX, >1.05*preRX if >ULN preRX; >ULN if <LLN preRX, <LLN if >ULN preRX; potassium: chloride: calcium: phosphorous:|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
113644|NCT00705289|Primary|Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.|At Baseline|All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.||Score on a scale||Standard Deviation|Mean
113824|NCT00703391|Secondary|Sputum Differential Neutrophil Count|Change from baseline to Day 14 in percentage neutrophil count|Pre-dose day -1 to post-dose on day 14|||Percentage||Full Range|Median
113630|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): <65 or >220. Glucose, fasting(mg/dL): <0.8*LLN or >1.5* ULN; if preRX<LLN, use <0.8*preRX or >ULN; if preRX>ULN, use >2.0*preRX or <LLN. Protein, total (g/dL): <0.9*LLN or >1.1*ULN; if preRX<LLN, use 0.9*preRX or >ULN if preRX >ULN, use 1.1*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX<LLN use <0.75*preRX. Uric acid (mg/dL): >1.5*ULN; if preRX>ULN use >2*preRX. Protein, urine: if missing preRX, use>=2; if >=4; if preRX=0 or 0.5, use >=2; if preRX=1, use >=3, or if preRX=2 or 3, use >= 4. Glucose, urine: if preRX missing, use >=2; if >=4, or if preRX=0 or 0.5 use >=2,or if preRX=1, use >=3, or if preRX=2 or 3 use >=4. Blood, urine: if preRX missing, use>= 2, or if >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3; if preRX=2 or 3 use >=4. WBC, urine (hpf): if missing preRX, use>= 2, or if >= 4, or if preRX =0 or 0.5 use >=2, or if preRX=1 use >=3, or if preRX=2 or 3 use >=4.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
113631|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): >3g/dL drop from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/L): <0.67*LLN or >1.5*ULN, or <100,000/mm^3 or if preRX<LLN, use <0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN, >1.25*ULN, <0.8*preRX if preRX <LLN or >1.2*preRX if preRX >ULN; >ULN if preRX <LLN, <LLN if >ULN preRX; neutrophils+bands (*10^3 c/uL): if value <1.00*10^3 c/uL; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL; monocytes (*10^3 c/uL): if value >2000/mm^3; basophils (*10^3 c/uL): if value >400/mm^3; eosinophils (*10^3 c/uL): if value> 0.750*10^3 c/uL|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
113632|NCT00705367|Primary|Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities|Laboratory tests consisted of complete blood count, chemistry, and urinalysis.|Screening and Days 1 and 2|All participants who received at least 1 dose of study drug||Participants|||Number
113633|NCT00705367|Primary|Short-term Period: Mean Temperature|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||Degrees Celsius||Standard Deviation|Mean
113634|NCT00705367|Secondary|Maximum (Cmax) Plasma Concentration of Abatacept|Cmax is a drug's maximum, or peak, concentration observed after its administration.|Postdosing Day 1|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.||ug/mL||Geometric Coefficient of Variation|Geometric Mean
113635|NCT00705367|Primary|Short-term Period: Mean Respirations Rate|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||Respirations per minute||Standard Deviation|Mean
113636|NCT00705367|Primary|Short-term Period: Mean Heart Rate|Vital signs measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||beats per minute||Standard Deviation|Mean
113637|NCT00705367|Primary|Short-term Period: MeanSystolic and Diastolic Blood Pressure|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.||mm Hg||Standard Deviation|Mean
113638|NCT00705367|Primary|Short-term Period: Number of Adverse Events (AEs) Related to Study Drug|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.||Events|||Number
113639|NCT00705367|Secondary|Minimum (Cmin) Plasma Concentration of Abatacept|Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.|Days 15, 29, 85, 169, 253 and 337|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.||ug/mL||Standard Deviation|Mean
113640|NCT00705367|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 infusion of abatacept during the open-label long-term extension period of the study.||Participants|||Number
113641|NCT00705367|Primary|Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.||Participants|||Number
113642|NCT00705341|Secondary|Predictive Value of Methacholine Challenge Test for Phase 1|Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls|one time|||% predictive value||95% Confidence Interval|Number
113825|NCT00703391|Secondary|Sputum Absolute Neutrophil Count|Change from baseline to Day 14 in absolute neutrophil count|Pre-dose day -1 to post-dose on day 14|||10**9/L||Full Range|Median
113648|NCT00705289|Primary|Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.||Score on a scale||Standard Deviation|Mean
113649|NCT00705263|Primary|Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.|Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.|After 4 weeks of treatment.|Patients with chronic hepatitis C treated with PegIntron pen plus Rebetol||Satisfied Participants|||Number
113650|NCT00705250|Primary|Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.|The percentage of evaluable participants who achieved either a complete response or partial response.|up to 3 years|||percentage of evaluable participants|||Number
113651|NCT00705224|Secondary|Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline|Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study.|Week 12 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 210 participants demonstrated early virological response (N=158 and N=50). 2 participants of the 210 had missing values.||Percentage of Participants|||Number
113652|NCT00705224|Secondary|Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively).|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 29 participants demonstrated virological relapse (N=18 and N=11) and were therefore included in this analysis.||Percentage of Participants|||Number
113653|NCT00705224|Secondary|Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline|Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration.|Week 24 or 48 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 208 achieved RFT (N=156 and N=51) and were therefore included in this analysis. 1 participant of the 208 had missing values.||Percentage of Participants|||Number
113654|NCT00705224|Secondary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 181 achieved SVR (N=140 and N=40) and were therefore included in this analysis. 1 participant of the 181 had missing values.||Percentage of Participants|||Number
113655|NCT00705224|Primary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study|Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study.||Percentage of Participants||95% Confidence Interval|Number
113656|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3|Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 7|Study eye ITT population, subjects with non-missing data||Score on a scale||Standard Deviation|Mean
113657|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2|Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 3|Study eye, ITT population, non-missing data||Score on a scale||Standard Deviation|Mean
113826|NCT00703391|Primary|QTcF|QTcF change from baseline greater than 60 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
113658|NCT00705159|Primary|Change From Baseline in the Total Blepharoconjunctivitis Grade.|Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to 15 days|Study eye, ITT Population, Non-missing data||Score on a scale||Standard Deviation|Mean
113659|NCT00705146|Secondary|Pain|AUSCAN 3.1 pain subscale. Possible score range is 0 to 50. Lower scores indicate less pain. Change scores are reported (baseline to 4 weeks splint wear) for each of the two splints.|4 weeks|Pooled all participants for the phase they wore the hybrid, then comfort cool splints, respectively. Mean change scores are reported||units on a scale||95% Confidence Interval|Mean
113660|NCT00705146|Primary|Hand Function|Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.|4 weeks|Pooled participants from both arms from the phase they wore the hybrid splint, then from the phase they wore the comfort cool splint. Mean change scores are reported.||units on a scale||95% Confidence Interval|Mean
113661|NCT00705107|Secondary|Average Length of Treatment.||Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.|||weeks||Standard Deviation|Mean
113662|NCT00705107|Primary|Number of Subjects Who Completed Treatment.||Assessed at the end of the 48-week treatment.|All participants||Participants|||Number
113663|NCT00705081|Primary|Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy|Achievement of LDL-C target levels as determined by physician|4-6 weeks after the first visit|All patients enrolled||Participants|||Number
113664|NCT00705081|Primary|Intensity of Adverse Events Reported|Intensity of adverse events reported after co-administration therapy|4-6 weeks after the first visit|All participants enrolled||Participants|||Number
113665|NCT00705081|Primary|Number of Participants Reporting Adverse Events|Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)|4-6 weeks after the first visit|All participants enrolled||Participants|||Number
113666|NCT00705016|Secondary|Safety - Number of Participants Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Safety population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab.||participants|||Number
113667|NCT00705016|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
113668|NCT00705016|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
113669|NCT00705016|Secondary|Disease Control Rate|The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
113670|NCT00705016|Secondary|Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
113671|NCT00705016|Secondary|Overall Survival (OS) Time|The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
113672|NCT00705016|Primary|Progression-free Survival (PFS) Time: Investigator Read|The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Intention-to-treat (ITT) population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
113827|NCT00703391|Primary|QTcF (QT Interval Corrected for Heart Rate by Fridericia’s Method)|QTcF interval greater than 450 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
113673|NCT00705003|Secondary|The Change From Baseline on the HAM-A at Week 6|"The 14-item HAM-A scale rates the patient’s level of anxiety based on feelings of anxiousness, tension, and depression; any phobias, sleep disturbance, or difficulty in concentrating; the presence of genitourinary, cardiovascular, respiratory, autonomic or somatic symptoms; and the interviewer’s assessment of the patient’s appearance and behavior during the interview. Each item is to be scored on a 5 point scale with 0 reflecting no symptoms and 4 reflecting symptoms of maximum symptom severity (Hamilton 1960).~The items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 56 units on a scale, where higher scores indicate more severe anxiety. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement."|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
113674|NCT00705003|Secondary|The Change From Baseline in the Quick Inventory of Depressive Symptomatology – 16 Item Self-Report (QIDS-SR16) at Week 6|"The QIDS-SR16 is a 16 question, patient rated scale that assesses the 9 Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision criterion diagnostic symptom domains including sad mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease or increase in appetite or weight, & psychomotor agitation or retardation. Each item is measured on a scale of 0 to 3. To find total score, you enter:~highest score from items 1-4 (Sleep Items)~item 5 score~highest score from items 6-9 (appetite/weight)~item 10 score~item 11 score~item 12 score~item 13 score~item 14 score~highest score from items 15-16 (psychomotor) These 9 scores are summed to find total score. Total minimum score is 0 units on a scale & total maximum score is 27 units, where higher scores indicate more severe depression. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement"|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
113675|NCT00705003|Secondary|The Change From Baseline in the IDS-C30 at Week 6|The Inventory of Depressive Symptomatology is a 30-item scale that assesses criteria including mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep, decrease/increase in appetite or weight, psychomotor agitation or retardation, diurnal mood variation, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. Items are scored on a 4 point scale with 0 reflecting no symptoms and 3 reflecting symptoms of maximum severity. The total score is calculated by summing the scores from 28 of the 30 items. Only one of items 11 or 12, and only one of items 13 or 14 are scored. The minimum score is 0 and the maximum score is 84. A score of 84 indicates maximum severity of depressive symptoms. Change from baseline is calculated as the baseline score minus the post-baseline score. A positive change indicates improvement.|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
113676|NCT00705003|Secondary|The Change From Baseline in the CGI-S at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). The CGI-S is a sub-scale of the Clinical Global Impression. The Investigator was asked: “Considering your total clinical experience with patients with this particular population, please assign a rating to how mentally ill the subject is at this time.”~Possible responses include the following:~0: Not Assessed~Normal, not ill at all~Borderline mentally ill~Mildly ill~Moderately ill~Markedly ill~Severely ill~Among the most extremely ill patients. The change from baseline CGI-S score was calculated as the baseline CGI-S score minus the post-baseline CGI-S score, such that a positive change indicated an improvement from baseline."|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Deviation|Mean
113677|NCT00705003|Primary|The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S)~The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to “Rate the patient’s total improvement whether or not, in your judgment, it is due entirely to drug treatment.” The Investigator was asked “Compared to the patient’s condition at the Baseline visit, please assign a rating to how much the patient changed.” Responses for the CGI-I evaluation included the following categories:~0: Not Assessed~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Week 6|142 subjects were enrolled and randomized in the study. 8 of these subjects were randomized but never received study drug. Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.||units on a scale||Standard Error|Mean
113678|NCT00704964|Primary|Number of Participants With Adherence to Therapy According to Physician Approximation|Adherence was based on physiciant's clinical judgment.|Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3|||Participants|||Number
113679|NCT00704964|Primary|Number of Participants With Biometrical Adherence to Therapy|Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.|Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3|||Participants|||Number
113680|NCT00704938|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module.|5 months|||Participants|||Number
113686|NCT00704847|Primary|Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||Units on a scale||Standard Deviation|Mean
113687|NCT00704847|Secondary|• Bone & Cartilage Metabolism Biochemical Marker Change. • Questionnaires to Assess Function, Stiffness, Pain, Physical Activity, and Quality of Life • Knee Disease Progression Assessed by MRI||From baseline to 24 months||||||
113688|NCT00704847|Primary|Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||mm||Standard Deviation|Mean
113689|NCT00704808|Primary|Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme||After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide|Intent-to-Treat population||Months||Standard Error|Median
113690|NCT00704769|Primary|General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments|Physicians judged the subjects as good, excellent, fair, or poor.|Minimum of 7 days after initiation of desloratadine|||Participants|||Number
113691|NCT00704769|Primary|Adverse Events|An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.|Minimum of 7 days after initiation of desloratadine|||Participants|||Number
113692|NCT00704730|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject’s time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.|Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.||% of participants|||Number
113693|NCT00704730|Secondary|Biochemical Response Calcitonin (CTN) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject’s time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.|Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.||% participants|||Number
113711|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.|The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.|Week 48|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.||Percentage of participants|||Number
113828|NCT00703391|Primary|Leucocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||10**9/L||Standard Deviation|Mean
113694|NCT00704730|Secondary|Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined|For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.|From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.|The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.||months||95% Confidence Interval|Median
113695|NCT00704730|Secondary|Objective Response Rate (ORR)|The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR|Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.|The primary analysis Objective Response Rate (ORR) was performed among subset of Intent To Treat (ITT) subjects with measurable disease at baseline (N = 208 cabozantinib, N = 104 placebo) based upon response determined by Independent Radiology Committee (IRC.) Subjects without post-baseline adequate tumor assessments - counted as nonresponders.||% of participants|||Number
113696|NCT00704730|Secondary|Overall Survival (OS) With XL184 Compared With Placebo|Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.|The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.|Intent to treat (ITT) randomized to either XL184 or placebo||months||95% Confidence Interval|Median
113697|NCT00704730|Primary|Progression-Free Survival (PFS)|The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.|Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.|Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.||months||95% Confidence Interval|Median
113698|NCT00704717|Primary|Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.|The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.|The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.|||Units on a scale||Standard Deviation|Mean
113699|NCT00704535|Primary|Tolerability as Measured by Subject Self-assessment|Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment|28 days after Visit 1|||subjects|||Number
113700|NCT00704535|Primary|Safety as Measured by Outcome of Adverse Events|To evaluate overall safety of ezetimibe as measured by outcome of adverse events|28 days after Visit 1|||adverse events|||Number
113701|NCT00704535|Primary|Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event|To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event|28 days after Visit 1|||adverse event|||Number
113702|NCT00704535|Primary|Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.|To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.|28 days after Visit 1|||adverse events|||Number
113703|NCT00704535|Primary|Safety as Measured by Severity of Adverse Events as Determined by the Investigator|To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator|28 days after Visit 1|||adverse events|||Number
113704|NCT00704535|Primary|Safety as Measured by Number and Type of Adverse Events.|Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.|28 days after Visit 1|||adverse events|||Number
113705|NCT00704535|Secondary|To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)|Change in mean total cholesterol values|28 days after Visit 1|All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements||mg/dL||Standard Deviation|Mean
113706|NCT00704535|Primary|Safety as Measured by Number of Subjects With at Least One Adverse Event|Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event|28 days after Visit 1|||subjects|||Number
113707|NCT00704522|Primary|Average Length of Treatment With PegIntron/Rebetol||After start of treatment|Number of participants who received study drug||Weeks||Standard Deviation|Mean
113708|NCT00704522|Primary|Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program||24 or 48 weeks (depending on genotype) and 24 weeks of follow up|All participants||Participants|||Number
113709|NCT00704418|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses|Day 1|LOCF Analysis, ITT Population||participants|||Number
113710|NCT00704418|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis(LOCF), ITT Population||participants|||Number
113829|NCT00703391|Primary|Reticulocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||relative particle count (%)||Standard Deviation|Mean
113712|NCT00704405|Secondary|Percentage of Participants Achieving cEVR|The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.|Up to Week 60|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis.||Percentage of participants|||Number
113713|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.|The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.|72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.||Percentage of participants|||Number
113714|NCT00704405|Primary|Number of Participants Discontinuing From Study Treatment Due to AEs|The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.|Up to 48 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.||Number of participants|||Number
113715|NCT00704405|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|Up to 73 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.||Number of participants|||Number
113716|NCT00704405|Primary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.|The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.|Up to 72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.||Percentage of participants|||Number
113717|NCT00704379|Secondary|Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus)|"FA is a measured obtained from Diffusion Tensor Imaging, an image modality of Magnetic Resonance Imaging (MRI). FA is a unitless index. Range: 0 to 1. FA describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted or equally restricted in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. In the context of this study, FA measures the integrity of the cingulate gyrus white matter. Higher FA values reflect higher integrity of the cingulate gyrus white matter tract. Average FA values for the right and left cingulate gyri were summed.~One aim of this project was to identify predictors of the occurrence of mood disturbances during the first 6 months following TBI. The hypothesis for this aim was that patients who develop a mood or anxiety disorder six months after TBI present at baseline with lower FA of the cingulate gyrus than those who do not."|Baseline|Of the 94 participants randomized, only 61 participants had an MRI and were included in the analysis of this study aim.||unitless index||Standard Deviation|Mean
113718|NCT00704379|Secondary|Social Functioning Examination Total Score|The Social Functioning Examination (SFE) is a semi-structured interview that measures social functioning in areas such as interpersonal relationships, work adjustment, use of community resources and satisfaction with living environment. Range: 0 to 1. Higher scores denote lower levels of social functioning.|6 months after TBI|Out of the 80 participants who completed the trial, only 63 completed SFE at this evaluation time.||units on a scale||Standard Deviation|Mean
113719|NCT00704379|Secondary|Memory Function Composite|This outcome measures memory function and is a composite of five standardized scores: Brief Visuospatial Memory Test - Revised, Delayed Recall and California Verbal Learning Test, Short Delay Free Recall Number Correct and Discriminability, and Long Delay Free Recall Number Correct and Discriminability. Standardized scores (i.e., z-scores) for each test of this composite were obtained by subtracting the mean raw score of all participants to the raw score of each participant and dividing the result by the standard deviation of the raw scores of all participants. The composite score was obtained by averaging the z-scores of the four memory tests mentioned previously. Range: -3 to 3. Higher scores represent better memory function.|6 months following traumatic brain injury|Out of the 80 participants who completed the trial, only 61 completed all the tests necessary to calculate the composite score at this evaluation time.||z-scores||Standard Deviation|Mean
113720|NCT00704379|Secondary|Iowa Gambling Task Score|The Iowa Gambling Task (IGT) evaluates decision making ability. During IGT subjects have to choose between decks of cards which yield high immediate gain but larger future loss (i.e., long term loss), and decks which yield lower immediate gain but a smaller future loss (i.e., a long term gain). The task consists of four decks of cards: A, B, C, and D. The goal in the task is to maximize profit. Subjects are required to make a series of card selections. The decks A and B are long term loss decks and the decks C and D are long term gain decks. The IGT Score reported is the combination of the raw score for each deck combined in the following way: (C+D) - (A+B). The range for this score is: -100 to 100. Higher values of this score indicate better decision making ability.|6 months after TBI|Out of the 80 participants who completed the trial, only 64 completed IGT at this evaluation time.||units on a scale||Standard Deviation|Mean
113721|NCT00704379|Secondary|Total Community Integration Questionnaire Scores|The Community Integration Questionnaire (CIQ) is intended as a brief, reliable measure of an individual’s level of integration into the home and community following traumatic brain injury. Total CIQ scores were used as the outcome measure. Range: 0 to 25. Higher scores indicate higher levels of integration into the home and community following TBI.|6 months after TBI|Out of the 80 participants who completed the trial, only 68 completed CIQ at this evaluation time.||units on a scale||Standard Deviation|Mean
113722|NCT00704379|Primary|Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)|"Following the DSM-IV (now updated by the DSM-5), depressive disorders associated with TBI are categorized as Mood Disorder Due to Another Medical Condition with subtypes: 1) With major depressive-like episode (if the full criteria for a major depressive episode [MDE] are met) or 2) With depressive features (prominent depressed mood but full criteria for a MDE are not met); and 3) with mixed features (e.g. significant irritability, pressured speech and formal thought disorder).~On the other hand, bipolar and related disorders due to TBI are subdivided in: 1) with manic or hypomanic like episode; 2) with manic features; and 3) with mixed features.~A similar conceptual framework has been used to define Anxiety Disorder due to another Medical Condition, in this case, TBI. According to DSM-IV/DSM-5, such diagnosis can be made when, besides an evident pathophysiological relationship with TBI, panic attacks or generalized anxiety are the prominent features of the clinical presentation."|6 months after TBI|||weeks||Standard Error|Mean
113723|NCT00704353|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAE's)||through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)|||participants|||Number
113724|NCT00704340|Secondary|Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak|"As determined from clinical diagnosis by one of the following methods:~CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 30 days post-operation~CSF leak confirmation by diagnostic testing within 30 days post-operation~CSF leak confirmation by clinical evaluation including physical examination of the surgical site within 30 days post-operation"|30 days|||percent of subjects||95% Confidence Interval|Number
113725|NCT00704340|Secondary|Percentage of Subjects With Post-operative Surgical Site Infections||30 days|||percent of subjects||95% Confidence Interval|Number
113726|NCT00704340|Primary|Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.|"Surgical Wound Complications;~Superficial incisional surgical site infection (SSI)~Deep incisional SSI~Organ/Space SSI~Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery~Poor wound healing~Central Nervous System Events;~Cerebrospinal Fluid (CSF) leak~Hydrocephalus~Bacterial meningitis~Aseptic meningitis~In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted."|30 days|||percent of subjects||95% Confidence Interval|Number
113727|NCT00704184|Secondary|Mean Log Change From Baseline in HCV RNA|The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Log10 IU/mL||Standard Deviation|Mean
113728|NCT00704184|Secondary|Number of Participants With ≥3-log10 Decrease in HCV RNA|The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Number of Participants|||Number
113729|NCT00704184|Secondary|Number of Participants With ≥2-log10 Decrease in HCV RNA|The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Number of Participants|||Number
113730|NCT00704184|Primary|Number of Participants Discontinuing From Study Therapy Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.|Day 1 to Day 28|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy||Participants|||Number
113731|NCT00704184|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.|Up to Day 42|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.||Participants|||Number
113732|NCT00704184|Primary|Percentage of Participants Achieving RVR|Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.|Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.||Percentage of Participants|||Number
113733|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge|Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles|30 days|Analysis by grade of air leak.Grade 1= countable air bubbles, Grade 2= Stream of bubbles, Grade 3 = Coalesced bubbles.||Percentage of participants|||Number
113734|NCT00704171|Secondary|Duration of Hospitalization||30 days|||hours||Standard Deviation|Median
113735|NCT00704171|Secondary|Duration of Chest Drainage||30 days|||hours||Standard Deviation|Median
113736|NCT00704171|Secondary|Time From Skin Closure to Last Observable Air Leak.||30 days|||hours||95% Confidence Interval|Median
113737|NCT00704171|Secondary|Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.|Success is defined as no presence of air leak intra-operatively.|Intra-operatively, time of study procedure|||Percentage of participants|||Number
113738|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.||30 days|||Percentage of participants|||Number
113769|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113739|NCT00704132|Primary|Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6|Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.|Baseline and Week 6|Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.||mg*hr/dL||95% Confidence Interval|Least Squares Mean
113740|NCT00704028|Primary|The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)||Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer|||participants|||Number
113741|NCT00703963|Secondary|Mean Number of INR Tests Performed||baseline to 3 months|||INR tests||Standard Deviation|Mean
113742|NCT00703963|Secondary|Mean Percentage of INR Tests Within the Therapeutic Range||baseline to 3 months|||percentage of tests||Standard Deviation|Mean
113743|NCT00703963|Primary|Mean Percentage of Time in Therapeutic Range||baseline to 3 months|||percentage of time||Standard Deviation|Mean
113744|NCT00703937|Primary|Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC|Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent|First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer|||participants|||Number
113745|NCT00703924|Secondary|Rate of Relapse|Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180|180 days|||Participants|||Count of Participants
113746|NCT00703924|Secondary|Final Cure Rate by Subject of All Lesions|Final cure rate by subject was determined using the Fisher's exact test|180 days|||Participants|||Count of Participants
113747|NCT00703924|Secondary|Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse|100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.|180 days|Days to 100% re-epithelialization of index lesion. Volunteer Identification Number (VIN). VINs 17, 72, and 109 failed to meet 100% re-epithelialization||Participants|||Count of Participants
113748|NCT00703924|Primary|Efficacy and Safety of WR 279,396 (AEs and SAEs)|Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.|180 days|All solicited local and systemic AEs and SAEs including immediate and delayed reactions that occurred during this study are summarized.||Adverse Events|||Number
113749|NCT00703924|Primary|Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)|CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test.|180 days|||Participants|||Count of Participants
113750|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113751|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (All Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113752|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113753|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (All Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113754|NCT00703911|Secondary|Adults' Health Related Quality of Life (Haemo-QoL-A): Overall Score|The adult Haemo-QoL-A is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of adult subjects above 16 years included in the study that completed the questionnaire at baseline and/or at discontinuation||scores on a scale||Standard Deviation|Mean
113755|NCT00703911|Secondary|Childrens' Health Related Quality of Life (Haemo-QoL): Overall Score|The Haemo-QoL is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of paediatric subjects age 4 to 16 (inclusive) included in the study that completed the questionnaire at baseline and/or at discontinuation||scores on a scale||Standard Deviation|Mean
113756|NCT00703911|Secondary|Overall Time to Cessation/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable.|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose, excluding bleed episodes treated with more than one dose for which > 24 hours between the 1st and 2nd dose was reported (bleed episodes with > 24 hours between 1st and 2nd rFVIIa dose likely reflects treatment of re-bleeding or prophylactic/maintenance dosing)||minutes||95% Confidence Interval|Median
113757|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||minutes||95% Confidence Interval|Median
113758|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (All Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||minutes||95% Confidence Interval|Median
113759|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (Spontaneous Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113760|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (All Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113761|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Symptom Relief (Spontaneous Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113762|NCT00703911|Secondary|Percentage of Patients Reporting Satisfaction With Symptom Relief (All Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113763|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (Spontaneous Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes. Excludes bleeds episodes with > 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing, and 2 bleed episodes categorised as CNS that would not meet criteria of mild to moderate spontaneous bleed episodes||mcg/kg||Full Range|Median
113764|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (All Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level. Excludes bleeds episodes with greater than 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing||mcg/kg||Full Range|Median
113765|NCT00703911|Secondary|Total Number of Injections (Spontaneous Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose||injections||Inter-Quartile Range|Median
113766|NCT00703911|Secondary|Total Number of Injections (All Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||injections||Inter-Quartile Range|Median
113767|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes)|Effective pain relief at 3 different time points for spontaneous bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113768|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes)|Effective pain relief at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113770|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113771|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113772|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113773|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose||percentage of bleed episodes|||Number
113774|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level||percentage of bleed episodes|||Number
113775|NCT00703885|Primary|Voxelwise Brain Imaging Data|Analysis of data not completed.|Post-Rx Administration||||||
113776|NCT00703885|Primary|Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing|Analysis not completed.|Same Day||||||
113777|NCT00703846|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the functional component, participants were asked to answer 15 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of the 12 question scores; total score ranges from 15 to 75.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
113778|NCT00703846|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the emotional component, participants were asked to answer 10 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of the 10 question scores; total score ranges from 10 to 50.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
113779|NCT00703846|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the symptomatic component, participants were asked to answer 7 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of the 7 question scores; total score ranges from 7 to 35.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
113780|NCT00703846|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.||units on a scale||Standard Deviation|Mean
113781|NCT00703846|Secondary|Median Number of Flare Days|The median number of flare days for all participants was calculated based on data self-reported in diaries that participants kept during the study. The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare day is defined as a day on which flare signs and symptoms for seborrheic dermatitis (erythema, scaling, and pruritus of the target area) occurred.|From baseline through 52 weeks|Safety Analysis Set||flare days||Full Range|Median
113782|NCT00703846|Secondary|Median Number of Flares|The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare is defined as a clinical diagnosis and presentation of seborrheic dermatitis that shows as an erythematous, thin, scaly patch with a greasy sandpaper texture that varies depending on disease severity. Flares are commonly seen on the scalp, nasal folds, eyebrows, glabella, upper eyelids, retroauricular/external ear canal, and midchest areas.|From baseline through 52 weeks|Safety Analysis Set||flares||Full Range|Median
113783|NCT00703846|Secondary|Mean Change From Baseline in Investigator’s Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|"This seborrhoeic dermatitis-specific ISGA scale (range=0-4) is used to assess skin condition severity without considering changes over time (static). 0=clear, except for minor residual discoloration; 1-4=majority of lesions have average scaling/erythema scores of 1-4, respectively. 1=almost clear, occasional fine scale, faint erythema/barely perceptible plaque thickness; 2= mild, fine scale with light coloration/mild plaque elevation; 3=moderate, coarse scale with moderate red coloration/moderate plaque thickness; 4=severe, thick tenacious scale with deep coloration/severe plaque thickness."|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
113784|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for pruritis ranges from 0 to 4; 0=No itching; 1=Minimal: rarely aware of itching; 2=Mild: only aware of itching at times; only present when relaxing; not present when focused on other activities; 3=Moderate: often aware of itching; annoying; sometimes disturbs sleep and daytime activities; 4=Severe: constant itching; distressing; frequent sleep disturbance; interferes with activities. Pruritus is defined as an itching/scratching sensation.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
113785|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline in skin assessments for scaling was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for scaling ranges from 0 to 4; 0=Normal skin with rare fine scale; 1=Minimal: occasional fine scales over less than 10% of the lesions; 2=Mild: fine scales predominate; 3=Moderate: coarse scales predominate; 4=Severe: thick tenacious scales predominate. Scaling of skin is the loss of the outer layer of the epidermis in large, scale-like flakes.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
113786|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or early termination) value minus the baseline value. The grading scale for erythema ranges from 0 to 4; 0=Normal skin without erythema; may have residual hyper/hypopigmentation; 1=Faint erythema; may have residual hyper/hypopigmentation; 2=Light red erythema; may have residual hyper/hypopigmentation; 3=Moderate red coloration; 4=Dusky to deep red coloration. Erythema was defined as redness of the skin caused by increased blood circulation in the capillaries found in the deeper layers of the skin.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.||units on a scale||Standard Deviation|Mean
113787|NCT00703846|Primary|Number of Participants With Any Adverse Event (AE)|"An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled Other (Non-Serious) Adverse Events."|From baseline through 52 weeks|Safety Analysis Set: all participants who had used the study product at least once||participants|||Number
113788|NCT00703781|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop|Day 1|LOCF Analysis, ITT Population||Participants|||Number
113789|NCT00703781|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT)||Participants|||Number
113790|NCT00703729|Secondary|Use of Pain Medication on Day 7|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
113791|NCT00703729|Secondary|Use of Pain Medication on Day 6|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
113792|NCT00703729|Secondary|Use of Pain Medication on Day 5|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
113793|NCT00703729|Secondary|Use of Pain Medication on Day 4|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
113794|NCT00703729|Secondary|Use of Pain Medication on Day 3|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
113795|NCT00703729|Secondary|Use of Pain Medication on Day 2|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
113796|NCT00703729|Primary|Patient Reported Pain on Day 7|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113798|NCT00703729|Primary|Patient Reported Pain on Day 5|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113799|NCT00703729|Primary|Patient Reported Pain on Day 4|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113800|NCT00703729|Primary|Patient Reported Pain on Day 3|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113801|NCT00703729|Primary|Patient Reported Pain on Day 2|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113802|NCT00703729|Primary|Patient Reported Pain on Day 1|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113803|NCT00703729|Secondary|Use of Pain Medication on Day 1|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day|||Morphine Equivalent Dosage||Standard Deviation|Mean
113804|NCT00703729|Primary|Patient Reported Pain on Day 0|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day|||Visual Analog Score (0-100)||Standard Deviation|Mean
113805|NCT00703677|Secondary|Geriatric Depression Scale(GDS)-15:Change From Baseline|The GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28.|28 weeks||||||
113806|NCT00703677|Secondary|Frontal Assessment Battery (FAB): Change From Baseline|The FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28.|28 weeks||||||
113807|NCT00703677|Secondary|PSP-Quality of Life Scale (QoL):Change From Baseline|The PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks||||||
113808|NCT00703677|Secondary|Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline|The UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28.|28 weeks||||||
113809|NCT00703677|Secondary|PSP Rating Scale Score: Change From Baseline|The PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks||||||
113810|NCT00703677|Secondary|Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity|Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28|28 weeks|Due to the very small number of samples collected, samples were not analyzed.|||||
113811|NCT00703677|Secondary|Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF|With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed|||||
113812|NCT00703677|Secondary|Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)|Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed|||||
113813|NCT00703677|Secondary|Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant.|28 weeks|All subjects were evaluated for compliance.||Subjects|||Number
113814|NCT00703677|Primary|Ability to Tolerate Lithium Carbonate|The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L.|28 weeks|One subject completed the full 28 week course of study drug; 13 subjects stopped drug early due to intolerability.||Subject|||Number
113815|NCT00703534|Primary|Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary|Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)|Run-in period of 8-12 days and treatment period of 26-30 days|None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.||participants|||Number
113816|NCT00703391|Primary|Renal Clearance of Drug From Plasma (CLR)|CLR following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||L/h||Full Range|Geometric Mean
113817|NCT00703391|Primary|Terminal Half-life of Drug in Plasma (t1/2)|t1/2 following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||hours||Full Range|Median
113818|NCT00703391|Primary|Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)|tmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||hours||Full Range|Median
113819|NCT00703391|Primary|Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)|Cmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||nM||Full Range|Geometric Mean
113820|NCT00703391|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))|AUC(0-12) following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)|||nM.h||Full Range|Geometric Mean
113821|NCT00703391|Primary|FEV1 (Forced Expiratory Volume in the First Second)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||L||Standard Deviation|Mean
113835|NCT00703391|Primary|Alanine Aminotransferase (ALT)|ALT level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)|||Participants|||Number
113836|NCT00703339|Secondary|Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects.|PK samples will be collected at frequent intervals up to 4 hours following single dosing . Hemodynamic parameters at 4 hours post dosing include heart rate, pulmonary arterial pressure, systemic arterial pressure, right atrial pressure, pulmonary capillary wedge pressure, mixed venous oxygen saturation and cardiac output.|acute||||||
113837|NCT00703339|Primary|Safety and Tolerability of Inhaled Treprostinil Sodium in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis,Reported as Number of Participants With Adverse Events|Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.|3-5 days|Insufficient enrollment, therefore no Participants were analyzed.||participants|||Number
113838|NCT00703326|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and other NSAEs is located in the Reported Adverse Event module.|First dose to study completion (up to 49 months) plus 30-day safety follow-up|All randomized participants who received at least 1 dose of study drug.||participants|||Number
113839|NCT00703326|Other Pre-specified|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The overall percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals.|Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event until data cutoff of 31-Mar-2013 (up to 31 months)|All randomized participants who received at least 1 dose of study drug with anti-IMC-1121B antibodies samples collected during the study.||percentage of participants|||Number
113840|NCT00703326|Secondary|Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns of breast cancer subscale (BCS) each with 6 or more items developed to measure problems specific to breast cancer symptoms plus additional items related to global QoL. Participants respond to each of the 36 questions on a 5-point scale from 0 (not at all) to 4 (very much) with a total scores range of 0-144. Higher scores indicate fewer symptoms and better HR-QoL.|Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 42 months)|A subset of Intent-to-Treat (ITT) Population: all randomized participants with a valid baseline and end of therapy assessments.||units on a scale||Standard Deviation|Mean
113841|NCT00703326|Secondary|Duration of Response|Duration of complete response (CR) or partial response (PR) measured from time criteria were first met for CR or PR until first date of progressive disease (PD) or death from any cause defined using Response Evaluation Criteria in Solid Tumor (RECIST 1.0); by Investigator assessment. CR defined as disappearance of all target and non-target lesions. PR defined as ≥30% decrease in sum of longest diameter (LD) of target lesions and no progression in non-target lesions. PD defined as ≥20% increase in LD sum of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of ≥1 new lesion(s). Participants who did not relapse or die censored at day of last radiographic tumor assessment. If death or PD was after ≥2 missing radiographic visits, censoring was at date of last radiographic visit prior to missed visits. Symptomatic/clinical disease progression without documented radiologic progression did not constitute progression.|Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 35 months)|A subset of the Intent-to-Treat (ITT) Population: all randomized participants with CR or PR. Censored participants: ramucirumab + docetaxel=80, placebo + docetaxel=28.||months||95% Confidence Interval|Median
113842|NCT00703326|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), based on the achievement of both measurement and confirmation criteria; by Investigator assessment. CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants.||percentage of participants||95% Confidence Interval|Number
113843|NCT00703326|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the first documented date of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who did not progress were censored at the last radiographic tumor assessment. If no post-baseline assessment was available censoring occurred at the date of randomization. If PD occurred after 2 or more missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=263, placebo + docetaxel=104.||months||95% Confidence Interval|Median
113930|NCT00702650|Secondary|Change From Baseline to Endpoint in Haemoglobin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||g/dL||Standard Deviation|Mean
113844|NCT00703326|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death or until data cutoff of 31-Mar-2013 (up to 49 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=448, placebo + docetaxel=225.||months||95% Confidence Interval|Median
113845|NCT00703326|Primary|Progression-Free Survival (PFS)|PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after ≥2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=231, placebo + docetaxel=94.||months||95% Confidence Interval|Median
113846|NCT00703261|Secondary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all statin-naive participants who completed the study and had complete image sets.||Percent reduction||90% Confidence Interval|Geometric Mean
113847|NCT00703261|Primary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all participants who completed the study and had complete image sets with usable data.||Percent reduction||90% Confidence Interval|Geometric Mean
113848|NCT00703118|Secondary|Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12|Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.|Week 4 and Week 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
113849|NCT00703118|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4||Baseline (Day 1) to Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||log10 IU/mL||Standard Deviation|Mean
113850|NCT00703118|Secondary|Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)|Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).|Up to Week 72|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
113851|NCT00703118|Secondary|Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8|Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.|Week 4, Week 6, or Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
113852|NCT00703118|Secondary|Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned|SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).|Week 60|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
113853|NCT00703118|Secondary|Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)||Week 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
113854|NCT00703118|Secondary|Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4|RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.||Participants|||Number
113855|NCT00703118|Primary|Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned|SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.|Week 72|Full Analysis Set: All randomized participants who received at least one dose of study medication.||Participants|||Number
113856|NCT00703092|Secondary|Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.||10 months||||||
113857|NCT00703092|Primary|Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.|||||
153937|NCT00352053|Secondary|Change From Baseline to Week 96 in HIV-1 RNA||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
113858|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses|The kinetics of the antibody response to vaccination with A/Vietnam/04 is evaluated by the HAI GMT against the A/Vietnam/04 antigen at weekly intervals after receipt of 2 doses 7, 14 and 28 days apart|Weeks 1, 2, 3 and 4 after the second dose|Analyses are based on a modified intent to treat population. 5 subjects in the VN/VN, Day 0, 28 group not receiving vaccination 2 are excluded, as were 2, also in this group, due to receipt of prohibited vaccines.||Titer||95% Confidence Interval|Geometric Mean
113859|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113860|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113861|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. The CI shown as 5.0 to 5.0 reflect that all subjects had a titer of 5.0 for the VN,VN, Day 0,14 and VN, Day 0 groups.|Six months after last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113862|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113863|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113864|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113865|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113866|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113876|NCT00703053|Secondary|Number of Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 180 days after the last vaccination.|Duration of study|All subjects receiving at least one study vaccination are included in the safety population and analyses of safety are intention to treat (ITT). Three subjects were randomized but not vaccinated.||Events|||Number
154032|NCT00352755|Secondary|Number of Participants Who Experience Surgical Complications Associated With This Regimen||Median follow-up was 32 months|||participants|||Number
113867|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113868|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113869|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113870|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113871|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Participants|||Number
113872|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113873|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113874|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after the second vaccination and review the Memory Aid with clinic staff at a follow up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after second vaccination|All subjects receiving the second vaccination are included in this outcome measure. The VN, Day 0 Group received only one dose.||Participants|||Number
113875|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after first vaccination|All subjects receiving the first vaccination are included in the safety population and analyses of safety are ITT. Three subjects were randomized but not vaccinated.||Participants|||Number
113912|NCT00702780|Primary|% Change of Whole Brain Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.||percentage of change||Standard Deviation|Mean
113877|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.||Titer||95% Confidence Interval|Geometric Mean
113878|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Percentage of Participants|||Number
113879|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Percentage of Participants|||Number
113880|NCT00703014|Primary|Number of Infants in Current Follow Up Trial Experiencing SAEs|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.||Participants|||Number
113881|NCT00703014|Primary|Number of Infants Born in Current Follow Up Trial Experiencing AEs|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.||Participants|||Number
113882|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Participants|||Number
113883|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.||Participants|||Number
113884|NCT00702949|Secondary|Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment|Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.|Baseline, after week 6 of treatment.|||units on a scale||Full Range|Median
113885|NCT00702949|Primary|Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||percent change||95% Confidence Interval|Median
113886|NCT00702949|Secondary|Toxicity Data for the Individual Study Arms From the Symptom Experience Diary .|A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).|Baseline, 6 weeks during treatment.|||units on a scale||Full Range|Median
113913|NCT00702780|Primary|% Change of Hippocampus Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.||percentage of change||Standard Deviation|Mean
113931|NCT00702650|Secondary|Change From Baseline to Endpoint in Estradiol||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||pg/mL||Standard Deviation|Mean
113887|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||percent change||95% Confidence Interval|Median
113888|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||units on a scale||95% Confidence Interval|Median
113889|NCT00702949|Secondary|Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|||percent change||95% Confidence Interval|Median
113890|NCT00702949|Secondary|Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|||Hot flashes per day||95% Confidence Interval|Median
113891|NCT00702949|Primary|Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).||units on a scale||95% Confidence Interval|Median
113892|NCT00702923|Secondary|Number of Participants With PSA Recurrence.|PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.|one year|||participants|||Number
113893|NCT00702923|Secondary|The Number of Participants With an Increase in PSA Doubling Time||Up to 18 months after last dose of study agent|||participants|||Number
113894|NCT00702923|Primary|The Number of Participants Who Developed Cancer Antigen-specific Immune Responses||Up to 12 months after treatment with study agent|||participants|||Number
113895|NCT00702845|Secondary|Number of Participants With Pregnancies|A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.|Up to 10 weeks after ET (up to a maximum of 14 weeks)|ITT Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.||Participants|||Number
113896|NCT00702845|Secondary|Number of Participants With Miscarriages|"A miscarriage, also known as a spontaneous abortion, was defined as the loss of a fetus without induction or instrumentation."|Up to 10 weeks after ET (up to a maximum of 14 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who had a biological pregnancy.||Participants|||Number
113897|NCT00702845|Secondary|Implantation Rate for Participants With ET|The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.|Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ET.||Percentage||Standard Deviation|Mean
113914|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 8 (84 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
113898|NCT00702845|Secondary|Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)|"Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. Other grade embryos were those that did not qualify as Grade 1, 2, or 3."|Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent IVF and/or ICSI.||Number of embryos||Standard Deviation|Mean
113899|NCT00702845|Secondary|Fertilization Rate|Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.|Up to 10 weeks after ET|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received fertilized oocytes.||Percentage||Standard Deviation|Mean
113900|NCT00702845|Secondary|Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)|The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).|Up to 36 hours after administration of hCG|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ICSI.||Number of oocytes||Standard Deviation|Mean
113901|NCT00702845|Secondary|Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration|For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.|Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||Follicles||Standard Deviation|Mean
113902|NCT00702845|Secondary|Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||pg/mL||Full Range|Median
113903|NCT00702845|Secondary|Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||nmol/L||Full Range|Median
113904|NCT00702845|Secondary|Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||pmol/L||Full Range|Median
113905|NCT00702845|Secondary|Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||IU/L||Full Range|Median
113906|NCT00702845|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||IU/L||Full Range|Median
113907|NCT00702845|Secondary|Total Duration of Stimulation (Days)|Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||Days||Full Range|Median
113908|NCT00702845|Secondary|Number of Days Treated With recFSH|Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||Days||Full Range|Median
113909|NCT00702845|Secondary|Total Dose of recFSH Administered From Day 8 Onwards|Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||International Unit (IU)||Full Range|Median
113910|NCT00702845|Secondary|Total Dose of recFSH Administered|Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.||International Unit (IU)||Full Range|Median
113911|NCT00702845|Primary|Number of Cumulus-oocyte-complexes Retrieved, Per Attempt|The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.|One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)|Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.||Number of cumulus-oocyte-complexes||Standard Deviation|Mean
157163|NCT00317941|Secondary|Percentage of Participants Without ISR Reported by Participants||Up to 3 months assessed every 24 hours after each injection|||Percentage of participants|||Number
113915|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 7 (72 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
113916|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 6 (60 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
113917|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 5 (48 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Deviation|Mean
113918|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 4 (36 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat||points on a scale||Standard Deviation|Mean
113919|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 3 (24 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat||points on a scale||Standard Deviation|Mean
113920|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 2 (12 wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat||points on a scale||Standard Deviation|Mean
113921|NCT00702754|Primary|Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms|7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms|Session 1 - Time 0, 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat||points on a scale||Standard Error|Mean
113922|NCT00702715|Secondary|Time to Recovery of T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.||seconds||95% Confidence Interval|Geometric Mean
113923|NCT00702715|Secondary|Time to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.||seconds||95% Confidence Interval|Geometric Mean
113924|NCT00702715|Primary|Time to Recovery of the T4/T1 Ratio to 0.9.|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.||seconds||95% Confidence Interval|Geometric Mean
113925|NCT00702702|Primary|Change in Hemoglobin vs Placebo|Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3|3 months|Study prematurely terminated for safety reasons|||||
113926|NCT00702689|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|41 months, 27 days|||Participants|||Number
113927|NCT00702689|Primary|Percent Change in Absolute Range of Motion (ROM) From Baseline to 6 Months|A change in ROM is 25% or greater from baseline. A partial response required improvement in 25% or more in ROM. Progression required 25% or greater loss of ROM.Patients with negative values in the Table are those who lost ROM.|6 months|||Percent change from baseline|||Number
113928|NCT00702650|Secondary|Change From Baseline to Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.||units on a scale||Standard Deviation|Mean
113929|NCT00702650|Secondary|Change From Baseline to Endpoint in Haematocrit|Haematocrit: percentage of total blood volume made up of blood cells|Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||percentage of red blood cells||Standard Deviation|Mean
113932|NCT00702650|Secondary|Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||mIU/mL||Standard Deviation|Mean
113933|NCT00702650|Secondary|Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)||Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.||ng/mL||Standard Deviation|Mean
113934|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Glucose||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||mg/dL||Standard Deviation|Mean
113935|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Insulin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.||uIU/mL||Standard Deviation|Mean
113936|NCT00702650|Secondary|Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||units on a scale||Standard Deviation|Mean
113937|NCT00702650|Secondary|Change From Baseline to Endpoint in Psychosexual Daily Questionnaire|Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||units on a scale||Standard Deviation|Mean
113938|NCT00702650|Secondary|Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL|Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
113939|NCT00702650|Secondary|Percentage of Participants With Cmax >2500 ng/dL|Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
113940|NCT00702650|Secondary|Percentage of Participants With Cmax Between 1800 and 2500 ng/dL|Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
113941|NCT00702650|Secondary|Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL|Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.||percentage of participants|||Number
113942|NCT00702650|Primary|Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120|Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. Participants were also included if they withdrew prior to Day 120 because of adverse event or lack of efficacy (considered as treatment failures).||percentage of participants||95% Confidence Interval|Number
113943|NCT00702624|Primary|Number of Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Live born infants|||Number
113944|NCT00702624|Primary|Number of Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Live born infants|||Number
113945|NCT00702624|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Participants|||Number
114043|NCT00701935|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months|Change in Diastolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.||mmHg||Standard Deviation|Mean
113946|NCT00702624|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.||Participants|||Number
113947|NCT00702624|Primary|Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.||Percentage of participants|||Number
113948|NCT00702546|Secondary|Percentage of Participants With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
113949|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
113950|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
113951|NCT00702546|Secondary|Percentage of Participants in Follow up Study With an Ecotopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711||Percentage of participants|||Number
113952|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711 with vital pregnancy||Percentage of participants|||Number
113953|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants in follow up study P05711 with a clinical pregnancy||Percentage of participants|||Number
113954|NCT00702546|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.|Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.||Percentage of participants|||Number
113955|NCT00702520|Primary|Take-Home Baby Rate|The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).|Birth of a one or more live babies (Up to 1 year)|Participants treated with Corifollitropin alpha in the base study (P05788, 38833).||Percentage of participants|||Number
113956|NCT00702520|Primary|Number of Infants Experiencing SAEs|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
113957|NCT00702520|Primary|Number of Infants Experiencing AEs|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
114044|NCT00701935|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months|Change in Systolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.||mmHg||Standard Deviation|Mean
113958|NCT00702520|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
113959|NCT00702520|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).||Participants|||Number
113960|NCT00702507|Secondary|Number of Participants With Mycological Cure of First to Third Recurrent Episodes|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed||participants|||Number
113961|NCT00702507|Secondary|Number of Participants With Clinical Cure of First to Third Recurrent Episodes|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clinical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed||participants|||Number
113962|NCT00702507|Secondary|Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as Successes; those without OC were categorized as Failures (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication."|Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed||participants|||Number
113963|NCT00702507|Secondary|Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.||scores on a scale||Full Range|Median
113964|NCT00702507|Secondary|Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.||scores on a scale||Full Range|Median
113965|NCT00702507|Secondary|Number of Participants With Mycological Cure|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population||participants|||Number
113966|NCT00702507|Secondary|Number of Participants With Clinical Cure|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clianical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population||participants|||Number
113967|NCT00702507|Primary|Number of Participants With Overall Cure (OC)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide [KOH] and culture results). Participants who had OC were categorized as Successes; those without OC were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|Modified Intent-to-Treat (MITT) Population: all participants who were dispensed study drug and had demonstrated clinical symptoms of diaper dermatitis (DD) (DD severity index score of 4-8; clinical erythema grade of >=2 [see outcome measure #4 for a description]) and confirmed Candida species (positive baseline KOH and culture for Candida species)||participants|||Number
113968|NCT00702468|Secondary|Carer Global Impressions of Change for Ease of Transfer|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject’s general functional abilities changed?”~How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35|||paticipants|||Number
113969|NCT00702468|Secondary|Carer Global Impressions of Change for Functional Ability|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject’s general functional abilities changed?”~How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35|||paticipants|||Number
113970|NCT00702468|Secondary|Subject Global Impressions of Change.|"At baseline subjects will write a brief description of their spasticity caused by MS and how it affects them emotionally, physically and their ability to function with day to day activities. This will be used to aid their memory before they answer the following question which is rated on a seven-point scale.~“Please assess the change in your spasticity due to MS since immediately before receiving the first course of study treatment (Baseline) using the scale below” The markers are: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better."|Day 35|||participants|||Number
113971|NCT00702468|Secondary|Daily Sleep Disruption NRS|Subjects will be asked: ”On a scale of 0-10 please indicate how your spasticity disrupted your sleep last night” with the anchors 0 = ‘did not disrupt sleep’, 10 = ‘completely disrupted (unable to sleep at all)’.|Week 1- Week 5|It is important to note that 16 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.||points on scale||Standard Deviation|Mean
113972|NCT00702468|Secondary|Timed 10-metre Walk.|The time taken to travel 10 metres.|Week 2 and Week 5|ITT. Only 4 placebo subjects were included in the analysis and 11 of the Sativex subjects. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||Seconds||Standard Deviation|Mean
113973|NCT00702468|Secondary|Change in Motricity Index|The Motricity Index involves assessing three movements in both the arms and the legs. In the arm the three movements are; pinch grip, elbow flexion and shoulder abduction and the three leg movements are, ankle dorsiflexion, knee extension and hip flexion. The total arm/leg score is then the addition of the score for the three arm/leg movements. One point is then added to each limb score so that the maximum score is 100 points. The higher the score the better the limb movement.|Week 2 and Week 5|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||points on scale||Standard Deviation|Mean
113974|NCT00702468|Secondary|Change in Modified Ashworth Scale.|"The Modified Ashworth Scale was completed at baseline and at the end of treatment at approximately the same time of day. All 20 muscle groups were assessed for spasticity (using a 0=no increase in muscle tone to 4 scale=affected part rigid in flexion or extensions), to result in a total score out of 80. The higher the score the worse the spasticity is.~The change from baseline to end of study was assessed. The higher the score the better"|Day 7 to Day 28|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||score on scale||Standard Deviation|Mean
113975|NCT00702468|Secondary|Change in Mean Daily Spasticity Severity as Measured on a Spasticity Severity 0-10 Numerical Rating Scale (NRS).|"Spasticity NRS was completed daily by answering the following question:~“On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. The change in mean spasticity severity NRS from baseline to end of study (last seven days)was calculated. A negative change from baseline indicates an improvement in spasticity."|Baseline (Week 1) to Week 5|It is important to note that 17 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.||points on scale||Standard Deviation|Mean
113976|NCT00702468|Primary|Number of Subjects Who Experience Treatment Failure.|The time to treatment failure was calculated as the number of days from the first day of treatment up to the day of treatment failure. The day of treatment failure was the earliest of:the day of premature cessation of study medication;the first day of the longest period, ending on the last day of treatment, where the mean spasticity NRS had increased by at least 20% and at least 1 unit from the treatment baseline; the day of a clinically relevant increase in anti-spasticity or disease modifying medication. The number of subjects who failed treatment were calculated.|Week 1- Week 5|||Participants|||Number
113977|NCT00702377|Primary|Corneal Staining|Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42|||Units on a scale||Standard Deviation|Mean
113978|NCT00702377|Primary|Conjunctival Staining|Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42|||Units on a scale||Standard Deviation|Mean
113979|NCT00702377|Primary|Tear Break-up Time|Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.|Day 0, Day 7, Day 14, Day 28, and Day 42|||seconds||Standard Deviation|Mean
113980|NCT00702364|Secondary|Neurobehavioral Functioning Inventory Depression Subscale|"Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring never, rarely, sometimes, often, or always. Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology."|Post treatment|||T-score||95% Confidence Interval|Mean
113981|NCT00702364|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score|The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms (“never”, “rarely”, “sometimes”, “often”, and “very often”). A previous study of the ASRS found the self-report to be both valid (Cronbach’s alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score.|Post treatment|||units on a scale||95% Confidence Interval|Mean
113982|NCT00702364|Primary|Stroop Test Interference T-score|The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.|Post treatment|||T-score||95% Confidence Interval|Mean
113983|NCT00702364|Primary|CDR Power of Attention|"Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.~Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,"|Post treatment|||msec||95% Confidence Interval|Mean
113984|NCT00702338|Primary|Number of Infants With SAEs During Follow-up|An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.||participants|||Number
113985|NCT00702338|Primary|Number of Infants With AEs During Follow-up|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.||participant|||Number
113986|NCT00702338|Primary|Number of Mothers With Serious AEs (SAEs) During Follow-up|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.||participants|||Number
113987|NCT00702338|Primary|Number of Mothers With Adverse Events (AEs) During Follow-up|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.||participants|||Number
113988|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis|Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Participants in the Intent-to-Treat group (ITT) in base study P05693 (NCT00697255) that received bolus injection of hCG.||percentage of participants|||Number
157164|NCT00317941|Secondary|Percentage of Injection Sites Per Participant With Reaction Reported by Physicians||Up to 3 months|||Percentage of ISR|Participants||Number
113989|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Intent-to-Treat group (ITT) consisted of all treated participants in base study P05693 (NCT00697255): 5 participants in Stage Ia and 3 participants in Stage Ib.||percentage of participants|||Number
113990|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|1 week|||Participants|||Number
113991|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away|1 week|||Participants|||Number
113992|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|12 week|||Participants|||Number
113993|NCT00702325|Secondary|Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)|There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
113994|NCT00702325|Secondary|Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment|There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.|12 weeks|||Proportion of Participants|||Number
113995|NCT00702325|Secondary|Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])|Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
113996|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away|12 week|||Participants|||Number
113997|NCT00702325|Secondary|Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period|Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||percentage of days||Standard Deviation|Mean
113998|NCT00702325|Secondary|Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period|Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||percentage of days||Standard Deviation|Mean
113999|NCT00702325|Secondary|Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period|Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||percentage of days||Standard Deviation|Mean
114000|NCT00702325|Secondary|Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period|Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Puffs/day||Standard Deviation|Mean
114001|NCT00702325|Secondary|Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Puffs/day||Standard Deviation|Mean
114002|NCT00702325|Secondary|Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Puffs/day||Standard Deviation|Mean
114003|NCT00702325|Secondary|Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period|Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Number of nights||Standard Deviation|Mean
114004|NCT00702325|Secondary|Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
114005|NCT00702325|Secondary|Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
114006|NCT00702325|Secondary|Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
114007|NCT00702325|Secondary|Number of Withdrawals Due to a Predefined Asthma Event|Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)|12 weeks|||Participants|||Number
114008|NCT00702325|Secondary|Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry|Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)|12 weeks|||Participants|||Number
114009|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period|Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/second||Standard Deviation|Mean
114010|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
114011|NCT00702325|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
114012|NCT00702325|Secondary|Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
114013|NCT00702325|Primary|Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
114014|NCT00702299|Secondary|Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed|Cmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration|18 months|||ug/mL||Standard Deviation|Mean
114015|NCT00702299|Secondary|Overall Survival||Average Length of follow-up 788 days|||Days||Full Range|Median
157165|NCT00317941|Secondary|Percentage of Injection Sites With Pain Reported by Physicians||Up to 3 months|||Percentage of sites|Participants||Number
114016|NCT00702299|Secondary|Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125|Progression was evaluated with posttreatment CT scans and measured changes in cancer antigen 125 levels 6 months after the initiation of the treatment regimen, or within one month after discontinuation of treatment if stopped early. Cancer antigen 125 response in evaluable patients (N=13) was analyzed using the modified Gynecologic Cancer Intergroup (GCIG) criteria. There was one evaluable patient by Response Evaluation Criteria in Solid Tumors(RECIST) criteria|18 months|||% of participants|||Number
114017|NCT00702299|Primary|Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)|Toxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0|18 months|||participants|||Number
114018|NCT00702299|Primary|Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the Maximum Tolerance Dose (MTD) would be determined to be the next lower dose level.|18 months|||% of participants|||Number
114019|NCT00702299|Primary|Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level.|18 months|||mg/m2|||Number
114020|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.||Percentage of participants|||Number
114021|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.||Percentage of participants|||Number
114022|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.||Percentage of participants|||Number
114023|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ectopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study.||Percentage of participants|||Number
114024|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a vital pregnancy.||Percentage of participants|||Number
114025|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a clinical pregnancy.||Percentage of participants|||Number
114026|NCT00702273|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.|Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial|ITT group from base trial P05787, consisting of randomized participants who were treated with Corifollitropin Alfa or recFSH.||Percentage of participants|||Number
114027|NCT00702234|Primary|Number of Live Born Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
114028|NCT00702234|Primary|Number of Live Born Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
114080|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Baseline to Week 25|The SDS comprised all treated patients.||participants|||Number
114029|NCT00702234|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
114030|NCT00702234|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.||participants|||Number
114031|NCT00702234|Primary|Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)|The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.|Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)|Participants administered corifollitropin alfa in base study P05714 (NCT00696878)||percentage of participants|||Number
114032|NCT00702221|Primary|Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)||baseline to 8 weeks|study prematurely terminated||mmHg||Standard Error|Mean
114033|NCT00702208|Primary|Kappa Coefficient|Kappa comparing clinician-collected cytology result to self-lavage cytology result|1-3 months between 2 specimen collections|||kappa coefficient for paired specimens||95% Confidence Interval|Number
114034|NCT00702208|Secondary|Outcome: Acceptability of Device|On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening|cross-sectional - asked at time of Screener use|For acceptability, 197 women used the device; 30 of these women did not have valid gold standard results but did respond to acceptability, thus for acceptability endpoint the sample size is 197 (while the sample size is 167 for sensitivity, specificity and kappa analyses due to insufficient sepcimens /loss to follow-up for colposcopy).||units on a scale||Inter-Quartile Range|Median
114035|NCT00702208|Primary|Sensitivity and Specificity|"We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.~The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints."|1-3 months between 2 specimen collections|||% of participants correctly diagnosed||95% Confidence Interval|Number
114036|NCT00702143|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.||SUVR||Standard Deviation|Mean
114037|NCT00702143|Secondary|Proportion of Positive Florbetapir-PET Scans|Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.||percentage of amyoid positive scans|||Number
114038|NCT00702143|Primary|Qualitative Amyloid Image Assessment|Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.||participants|||Number
114039|NCT00701935|Secondary|Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event|All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.||hypoglycemia rate/year||Standard Error|Mean
114040|NCT00701935|Secondary|Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months|Change in HDL cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||mmol/L||Standard Error|Least Squares Mean
114041|NCT00701935|Secondary|Change in Triglycerides From Baseline to 6 Months|Change in triglycerides|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||mmol/L||Standard Error|Least Squares Mean
114042|NCT00701935|Secondary|Change in Total Cholesterol From Baseline to 6 Months|Change in total cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||mmol/L||Standard Error|Least Squares Mean
114045|NCT00701935|Secondary|Change in Weight From Baseline to 6 Months|Change in weight|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analyzed.||kg||Standard Error|Least Squares Mean
114046|NCT00701935|Secondary|Change in Fasting Plasma Glucose From Baseline to 6 Months|Change in Fasting plasma glucose|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Analysis done only for patients with measurement at Month 6.||mmol/L||Standard Error|Least Squares Mean
114047|NCT00701935|Secondary|Percentage of Patients With HbA1c <=7.0% at 6 Months|Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received.Analysis done only for patients with measurement at Month 6.||Percentage of patients|||Number
114048|NCT00701935|Secondary|Change in HbA1c From Baseline to 6 Months|Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analysed.||% change||Standard Error|Least Squares Mean
114049|NCT00701935|Secondary|Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months|Percentage change in subcutaneous abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||% change||Standard Error|Least Squares Mean
114050|NCT00701935|Secondary|Percentage Change in Total Abdominal Fat From Baseline to 6 Months|Percentage change in total abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||% change||Standard Error|Least Squares Mean
114051|NCT00701935|Primary|Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months|Percentage change in abdominal visceral fat|baseline, 6 months|Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received||% change||Standard Error|Least Squares Mean
114052|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.||Percentage of participants|||Number
114053|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.||Percentage of participants|||Number
114054|NCT00701805|Other Pre-specified|The Percentage of Participants With Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)|Anytime from Week 13 through Week 53|||Percentage of participants|||Number
114055|NCT00701805|Secondary|Duration of 2 Consecutive iPTH Values <= 180 pg/mL||From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||days||Standard Deviation|Mean
114056|NCT00701805|Secondary|Duration of 2 Consecutive Decreases in iPTH >= 50%||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||days||Standard Deviation|Mean
114057|NCT00701805|Secondary|Change in Mean iPTH||Every week from Baseline through Week 13 and every other week thereafter until Week 53|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||pg/mL||Standard Deviation|Mean
114058|NCT00701805|Secondary|The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%||Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||Percentage of Participants|||Number
114059|NCT00701805|Secondary|The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||Percentage of participants|||Number
114060|NCT00701805|Secondary|The Mean Change in Intact Parathyroid Hormone (iPTH)||From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.||picograms/milliliter (pg/mL)||95% Confidence Interval|Mean
114061|NCT00701805|Primary|The Percentage of Participants With Hyperphosphatemia|The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.||Percentage of participants|||Number
114062|NCT00701805|Primary|The Percentage of Participants With of Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.||Percentage of participants|||Number
114063|NCT00701779|Primary|Prostate Specific Antigen|Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months|||ng/mL||Standard Deviation|Mean
114064|NCT00701779|Primary|Post-void Residual Volume|Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months|||mL||Standard Deviation|Mean
114065|NCT00701779|Primary|Benign Prostate Hyperplasia Impact Index|"Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Benign Prostatic Hyperplasia Impact Index asked the following:~Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)~Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)~Overall, how bothersome has any trouble with urination been during the past month? (0-3)~Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13."|12 months|||units on a scale||Standard Deviation|Mean
114066|NCT00701779|Primary|Peak Flow Rate (QMax)|Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months|||ml/sec||Standard Deviation|Mean
114067|NCT00701779|Primary|International Prostate Symptom Score|"Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.~Total range is from 0-35. The scores are evaluated as such:~0-7: Mild 8-19: Moderate 20-35: Severe"|12 months|||units on a scale||Standard Deviation|Mean
114068|NCT00701779|Secondary|Reduction of AUR and BPH-related Surgery|To assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior improvement in the clinical outcomes of AUR or BPH-related prostatic surgery to BPH patients.|13 months||||||
114069|NCT00701779|Secondary|Economic Impact|To assess the pharmacoeconomic impact on starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.|13 months||||||
114070|NCT00701779|Secondary|Safety and Tolerability|To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related.|13 months|||adverse events|||Number
114071|NCT00701779|Secondary|Health Outcome Measures|To assess the effects of starting with combination therapy with Dutasteride and Tamsulosin and subsequent withdrawal of Tamsulosin on health outcome measures.|13 months||||||
114072|NCT00701727|Secondary|High-density Lipoprotein (HDL)|Change from baseline in plasma HDL, measured in fasting blood samples|7 weeks|per protocol, all subjects||mg/dL HDL||Standard Deviation|Mean
114073|NCT00701727|Secondary|Low-density Lipoprotein (LDL);|Change from baseline in plasma low-density lipoprotein(LDL), measured in fasting blood samples|7 weeks|per protocol, all subjects||mg/dL LDL||Standard Deviation|Mean
114074|NCT00701727|Secondary|Triglycerides (TG)|Change from baseline in plasma triglycerides, measured in fasting blood samples|7 weeks|per protocol, all subjects||mg/dL TG||Standard Deviation|Mean
114075|NCT00701727|Secondary|Cholesterol Efflux Rate (Ra Cholesterol)|The efflux, or mobilization, rate of cholesterol from peripheral tissues into the plasma will be measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® and 10 % ethanol is given piggy-backed into normal saline over 20 hours (4pm – 12 noon). This is used to determine rate of appearance (Ra) cholesterol, which will be measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol that will be traced into biliary sterols.|7 weeks|per protocol, all subjects||mg/kg/hr cholesterol||Standard Deviation|Mean
114076|NCT00701727|Secondary|de Novo Cholesterol Synthesis (DNC)|Plasma DNC will be measured following the isotope infusion of deuterated water, expressed as %.|7 weeks|per protocol, all subjects||%/day plasma DNC||Standard Deviation|Mean
114077|NCT00701727|Secondary|Change From Baseline in Total Cholesterol, From Fasting Plasma Samples|plasma levels of total cholesterol|7 weeks|per protocol, all subjects||mg/dL total cholesterol||Standard Deviation|Mean
114078|NCT00701727|Primary|Fecal Excretion of Plasma-derived Cholesterol|"(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion:~The composition of fecal neutral and acidic sterols will be measured as % of total.~The excretion rate of fecal neutral and acidic sterols will be measured as mg/day.~The isotopic enrichment of both fecal neutral and acidic sterols will be measured as atomic percent excess (% APE).~Fecal isotope excretion, or recovery, of plasma-derived cholesterol will be calculated as %/day."|7 weeks|Per Protocol,all subjects||mg/day cholesterol excreted||Standard Deviation|Mean
114079|NCT00701675|Primary|Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg|Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of <17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.|11 weeks from baseline|sertraline 50mg group and placebo group each had 2 subjects with missing data.||units on a scale||95% Confidence Interval|Least Squares Mean
157649|NCT00312884|Primary|Days Alive and Outside of Hospital|Days alive and outside of hospital (i.e. not admitted)|From date of randomisation for 180 days|||Days||Inter-Quartile Range|Median
114081|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters.|Baseline to Week 25|The SDS comprised all treated patients.||participants|||Number
114082|NCT00701662|Secondary|Number of Patients With Local/Injection Site Reactions|All AEs arising from local/injection site reactions.|For the duration of the study, up to Week 25|The SDS comprised all treated patients.||participants|||Number
114083|NCT00701662|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered. Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The SDS comprised all treated patients.||AEs per infusion|Participants||Number
114084|NCT00701662|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The safety data set (SDS) comprised all treated patients.||participants|||Number
114085|NCT00701662|Secondary|Overall Health Status at Baseline and Week 25|Overall Health Status was assessed using a Visual Analogue Scale (VAS). Patients were asked to rate their overall health status by placing a mark on a 100 mm VAS, with 0 being the worst imaginable state and 100 being the best imaginable state.|Baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||units on a scale||Full Range|Mean
114086|NCT00701662|Secondary|Treatment Satisfaction at Baseline and Week 25|Treatment satisfaction was assessed using the Life Quality Index, which comprises 15 items rated on a 7-point scale (1 = worst rating, 7 = best rating) with a possible maximum score of 105. The highest score indicates the highest satisfaction with the impact of treatment on social factors. The 15 items were summarized to 4 scales: treatment interference, therapy-related problems, therapy setting, and treatment costs. The raw scores for these scales were transformed to a score ranging from 0 to 100, with 100 being the best score achievable.|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||units on a scale||Full Range|Mean
114087|NCT00701662|Secondary|Health-Related Quality of Life at Baseline and Week 25|"Assessed using a questionnaire on patients' satisfaction with current immunoglobulin G (IgG) treatment, treatment at home, and treatment at the hospital/doctor's office. The questions were answered by choosing a number between 1 (extremely good) and 7 (extremely bad).~Note: No patients received IgG treatment at the hospital/doctor's office at Week 25."|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||units on a scale||Full Range|Mean
114088|NCT00701662|Secondary|Mean Motor Function Score at Screening and Week 25|For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst).|Screening and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||Full Range|Mean
114089|NCT00701662|Primary|Mean Overall MRC Score at Baseline and Week 24|The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.|Baseline and week 24|The ITT data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.||score on a scale||Full Range|Mean
114090|NCT00701662|Secondary|Change From Baseline to the Completion Visit in Motor Function|"The change in motor function was determined at the completion visit compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method.~For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst). The baseline motor function score was calculated as the mean of the patient's assessments at Screening and Week 1. Negative values for change in motor function score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to the completion visit (up to week 25)|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||95% Confidence Interval|Mean
114091|NCT00701662|Secondary|Mean Disability Score at Baseline and Week 24|Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability.|Baseline and Week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||Full Range|Mean
114113|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (AcroQoL)|AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|"ITT population n = Number of subjects at the visit. Phase 1 only: These subjects participated only in phase 1 & did not move onto phase 2.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included"||Units on a scale||Standard Deviation|Mean
114092|NCT00701662|Secondary|Change From Baseline to Week 24 in Disability|"The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability. Negative values for change in disability score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).||score on a scale||95% Confidence Interval|Mean
114093|NCT00701662|Primary|Change From Baseline to Week 24 in Muscle Strength|"The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Baseline to week 24|The Intention-to-Treat (ITT) data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.||score on a scale||95% Confidence Interval|Mean
114094|NCT00701636|Primary|Mean Daptomycin Concentrations at 12, 18, 24, and 48 h|Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h|Hospital discharge or 7 days, whichever comes first|Based on sample sizes from previously published studies on antibiotic pk for CABG surgery.||mcg/ml||Standard Deviation|Mean
114095|NCT00701558|Secondary|Overall Survival|Overall survival was defined as the interval between the day of randomization and the date of death from any cause.|From the time of randomization until death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.||weeks||95% Confidence Interval|Median
114096|NCT00701558|Primary|Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the time of randomization until disease progression or death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.||percentage of participants|||Number
114097|NCT00701558|Primary|Time to Disease Progression|Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|From the time of randomization until disease progression or death (up to 193 weeks)]|Intention to treat (ITT) population included all participants who were randomized to treatment group.||weeks||95% Confidence Interval|Median
114098|NCT00701441|Other Pre-specified|Peroxynitrite Deposition in the Vascular Walls|A forearm biopsy will be collected to isolate human microcirculatory endothelial cells. The stain density of peroxynitrite, an indicator of oxidative stress, in the vascular walls is compared between pre-treatment and post treatment patient tissue. Also another comparison is made between pre-treatment and control tissue. The stain density is a software-generated measurement of pixel intensity and is considered to be an arbitrary unit. Higher numbers indicate greater density|baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and flow mediated dilation only.||stain density units||Standard Error|Mean
114099|NCT00701441|Primary|Flow Mediated Dilation|A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.|Baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and nitrotyrosine stain density values only.||percentage change of vessel diamter||Standard Error|Mean
114100|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Urine|Plasma samples were assayed for total urine GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal of <0.030 mg/mmoL of creatinine. Number of participants analyzed=participants with both baseline and post-baseline GL-3 urine clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.||Percent change||Standard Deviation|Mean
114101|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Plasma|Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 μg/mL. Number of participants analyzed=participants with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.||Percent change||Standard Deviation|Mean
114102|NCT00701415|Primary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of participants with none/trace, mild, moderate and severe biopsy scores.|Baseline, Week 52, Week 156 and Week 260|Analysis was performed on Full analysis set (FAS), which included all randomized participants who received at least 1 infusion of study treatment.||Percentage of participants|||Number
114103|NCT00701389|Secondary|Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The number of participants who were discontinued from the study due to adverse event was summarized.|up to 10 weeks|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.||Participants|||Number
114104|NCT00701389|Secondary|Number of Participants Who Experienced an Adverse Event During the Study|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 10 weeks)|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.||Participants|||Number
114105|NCT00701389|Secondary|Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered telcagepant or placebo in either Periods 1, 2, 3, or 4 regardless of sequence.||mmHg||95% Confidence Interval|Least Squares Mean
114106|NCT00701389|Primary|Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered sumatriptan with telcagepant or sumatriptan alone in either Periods 1, 2, 3, or 4 regardless of sequence and had evaluable blood pressure data obtained.||mmHg||95% Confidence Interval|Least Squares Mean
114107|NCT00701363|Secondary|Subject Treatment Schedule Preference|"At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.~At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Lan: Lanreotide~W: Week~Inj: Injection~Wks: Weeks~Phs: Phase~Grp: Group~evy: every"||Percentage of subjects|||Number
114108|NCT00701363|Secondary|Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL||At weeks 24 and 48|n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
114109|NCT00701363|Secondary|Serum Growth Hormone (GH) Levels||At Baseline, week 24 and week 48|"ITT population. n = Number of subjects at the visit.~Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2."||ng/mL||Standard Deviation|Mean
114110|NCT00701363|Secondary|Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit|"AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.~IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.~Correlation presented is a Spearman correlation (non parametric)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."||Correlation coefficient||95% Confidence Interval|Number
114111|NCT00701363|Secondary|Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48|The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.|At week 48 (End of Study)|"MITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."||Percentage of subjects||95% Confidence Interval|Number
114112|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (SF-36)|Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|ITT population. n = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.||Units on a scale||Standard Deviation|Mean
115482|NCT00687908|Secondary|Percent of Subjects With Adverse Events|All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent|Up to 24 weeks|||percent of subjects|||Number
114114|NCT00701363|Secondary|Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)|Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).|At baseline, week 24 and week 48|"ITT population.~Number of Participants Analyzed:~Phase 1 in week 24: 3~Phase 2 (Group A) in week 24: 13~Phase 2 (Group B) in week 24: 69~Phase 2 (Group C) in week 24: 25~Phase 2 (Group A) in week 48: 13~Phase 2 (Group B) in week 48: 68~Phase 2 (Group C) in week 48: 26~NA = Not Applicable"||Units on a scale||Standard Deviation|Mean
114115|NCT00701363|Secondary|Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24||Baseline (visit 1)|"ITT population. n = Number of subjects at the visit.~These subjects entered in phase 2~One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline."||Percentage of ULN||95% Confidence Interval|Mean
114116|NCT00701363|Secondary|Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C||Baseline (visit 1)|"MITT population.~One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48."||Percentage of ULN||95% Confidence Interval|Mean
114117|NCT00701363|Secondary|Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval|IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline|Baseline (visit 1) and week 48|MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.||Percentage of ULN||Standard Deviation|Mean
114118|NCT00701363|Secondary|Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels|The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.|At week 48|ITT population. n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
114119|NCT00701363|Secondary|Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks|The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.|During phase 2 of the study (up to week 48)|ITT population. n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
114120|NCT00701363|Secondary|Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)|The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.|At week 24|ITT population. n = Number of subjects at the visit.||Percentage of subjects||95% Confidence Interval|Number
114121|NCT00701363|Primary|Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)|A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)|At week 48 (End of Study)|"Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2).~n = Number of subjects at the visit"||Percentage of subjects||95% Confidence Interval|Number
114122|NCT00701311|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.~The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks|||participants|||Number
114123|NCT00701129|Primary|Disability Index Assessed by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at End of Study|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. It consists of all items of the original PEDI (197 functional skill items in 3 domains: self-care; mobility; and social function) and additional items in the functional skills, mobility, and self-care domains to reflect clinically relevant functional skills for children with Pompe disease. Each domain consisted of 2 subdomains: functional skill performance and caregiver assistance scale. Norm-based scoring was developed for these additional items, and scoring algorithms for the PEDI have been adjusted to reflect additional normative data collected for the Pompe PEDI. Total score range for each domain (mean of subdomains) and subdomain ranges from 0 to 100, where higher score indicates high capability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patient analyzed = number of patients with end of study Pompe PEDI assessment and n = number of patients with end of study assessment of specified category.||units on a scale||Full Range|Median
114136|NCT00701090|Primary|Change From Baseline in HbA1c at Week 30|Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||Percent||95% Confidence Interval|Least Squares Mean
114137|NCT00701064|Primary|Clinical Assessed PTSD Scale (CAPS-2) and Clinical Global Impression (CGI)|The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.|Mean change from baseline to post-treatment (5-6 weeks later)|Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data||change in units on scale||Standard Deviation|Mean
115640|NCT00686712|Secondary|Any Adverse Event Other Than Hypoglycemia||6 months||||||
114124|NCT00701129|Primary|Motor Development Status Assessed by Alberta Infantile Motor Scale (AIMS) at End of Study|"AIMS is a 58-item reliable and valid measure of motor development for infants at risk for motor delay. It assesses infant movement in 4 positions (subscales): prone (reciprocal crawling); supine (moving hands to feet); sitting (sitting with arm support); and standing (pulls to stand). For each subscale, items were scored as observed or not observed. Item in the observed range create a motor window. When scoring, subscale scores are calculated by giving the child credit (1 point) for observed items within the motor window in addition to being given credit (1 point) for all of the less mature items before motor window. AIMS total score was calculated by summing the scores for 58 items and ranged from 0 to 58, with higher score indicating more mature motor development. Score was then compared with age-equivalent peers from normative sample and equivalence level age (in months) is reported. End of study refers to the last post baseline observation during study period (up to Week 79)."|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study AIMS assessment.||months||Full Range|Median
114125|NCT00701129|Primary|Gross Motor Disability Assessed by Gross Motor Function Measure-88 (GMFM-88) at End of Study|GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item is scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension is expressed as a percentage of the maximum score for that dimension. Total score is obtained by adding the percentage scores for each dimension and dividing the sum by the total number of dimensions. Total score ranges from 0% to 100%, where higher scores indicate better motor functions. A total score of <7.5% demonstrates gross motor disability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study GMFM-88 assessment.||percentage of maximum total score||Full Range|Median
114126|NCT00701129|Primary|Number of Patients With Ventilator Use at End of Study|Number of patients who had ventilator support at end of study was reported. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
114127|NCT00701129|Primary|Number of Patients With Normal/Abnormal Left Ventricular Mass (LVM) Z-Score and LVM Index at End of Study|LVM Z-score and LVM index were assessed by ECHO. LVM Z-Score provides an indicator of degree of standard deviations from the mean in a normal distribution. Negative values indicate a smaller LVM than mean and values higher than 0 indicate a larger LVM than the mean. The normal range for LVM Z-Score is -2 to 2. Values <-2 or >2 indicate abnormal LVM Z-Score. LVM index is an index value derived by normalizing LVM by body surface area. LVM index provides evidence of cardiomyopathy. LVM index values <65 gram per meter^2 (g/m^2) were considered as normal and LVM index values >=65 g/m^2 were considered as abnormal. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
114128|NCT00701129|Primary|Number of Patients Who Survived at End of Study||Baseline up to End of study (Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
114129|NCT00701129|Primary|Number of Patients With Recombinant Human Acid Alfa-glucosidase (rhGAA) Inhibitory Antibody at End of Study|Patients with positive anti-rhGAA IgG antibody were assessed for the presence of inhibitory antibodies (inhibition of enzyme activity and inhibition of enzyme uptake). Enzyme-linked immunosorbent assay (ELISA) was used to measure inhibition of rhGAA enzymatic activity in vitro and a cell-based assay was used to measure the inhibition of the uptake of rhGAA in normal fibroblast cells by flow cytometry.|End of study (up to Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patients analyzed = patients with positive anti-rhGAA IgG antibody.||participants|||Number
114130|NCT00701129|Primary|Change From Baseline in Number of Patients With Anti-Recombinant Human Acid Alfa-glucosidase (Anti-rhGAA) Immunoglobulin G (IgG) Antibody at End of Study|Serum samples from patients were analyzed for the presence of anti-rhGAA IgG antibodies. End of study (EOS) refers to the last post baseline observation during study period (up to Week 79).|Baseline, End of Study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.||participants|||Number
114131|NCT00701090|Secondary|Percent of Patients With A1C <6.5% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||Percentage of Participants|||Number
114132|NCT00701090|Secondary|Percent of Patients With A1C <7.0% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||Percentage of Participants|||Number
114133|NCT00701090|Secondary|Change From Baseline in Body Weight at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|All patients who took at least one dose of study therapy and had body weight measurements at both baseline and Week 30.||Kilograms||95% Confidence Interval|Least Squares Mean
114134|NCT00701090|Secondary|Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30||Week 0 to Week 30|All patients who took at least one dose of study therapy.||Percentage of Participants|||Number
114135|NCT00701090|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).||mg/dL||95% Confidence Interval|Least Squares Mean
115641|NCT00686712|Secondary|Total Daily Insulin Dose||6 months||||||
114138|NCT00701051|Secondary|Body Composition (%Fat)||baseline, 24 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||percentage of fat||Standard Error|Mean
114139|NCT00701051|Secondary|Cardiorespiratory Fitness|Maximal oxygen consumption|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||L/Min||Standard Error|Mean
114140|NCT00701051|Primary|Skeletal Muscle Capillarization (Pre/Post Intervention)||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||capillaries/mm2||Standard Error|Mean
114141|NCT00701051|Primary|Baseline Skeletal Muscle Capillarization||baseline|||capillaries/mm2||Standard Error|Mean
114142|NCT00701051|Secondary|Baseline Cardiorespiratory Fitness|maximal oxygen consumption|baseline|||L/min||Standard Error|Mean
114143|NCT00701051|Secondary|2-hr Post-prandial Plasma Glucose Level||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||mg/dL||Standard Error|Mean
114144|NCT00701051|Primary|Glucose Utilization (Pre/Post Intervention)|Insulin-stimulated glucose uptake|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
114145|NCT00701051|Secondary|Baseline 2-hour Postprandial Glucose||baseline|||mg/dl||Standard Error|Mean
114146|NCT00701051|Primary|Baseline Glucose Utilization|Insulin-stimulated glucose uptake|baseline|||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
114147|NCT00701038|Primary|Left Ventricular Ejection Fraction Improvement|Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.|baseline and again after three nights in hospital|ITT||percent change||Standard Error|Mean
114148|NCT00700999|Primary|Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later.|Baseline and 12 weeks|The number of participants analyzed is only 17 in each arm. The total number of participants in the Intervention group who completed fMRI scans pre-treatment and post treatment is only 19, in the Combat Exposed Control Group it is 18. Three of the participants scans were removed from data analysis due to the level of movement during the scan.||percent change in BOLD signal||Standard Deviation|Mean
114149|NCT00700973|Primary|Addiction Severity Index Legal Composite|Scores range from 0 to 1, with higher scores indicating more severe legal problems.|One year post-intervention|||units on a scale||Standard Deviation|Mean
114150|NCT00700817|Secondary|Hypoglycaamic Episodes, Weeks 52-78|Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 52-78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||episodes|||Number
114151|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
114152|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.||episodes|||Number
114153|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
114154|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.||episodes|||Number
114171|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 26.|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||cm||Standard Error|Least Squares Mean
114155|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.||episodes|||Number
114156|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.||episodes|||Number
114157|NCT00700817|Secondary|Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 52, Week 78|Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia||scores on a scale||Standard Deviation|Mean
114158|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 52|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia||scores on a scale||Standard Error|Least Squares Mean
114159|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 26|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia||scores on a scale||Standard Error|Least Squares Mean
114160|NCT00700817|Secondary|Mean Change in Pulse From Week 52 to Week 78|Mean change in pulse from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||beats/minute||Standard Deviation|Mean
114161|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 52|Calculated as an estimate of the mean change from baseline in pulse at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
114162|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 26|Calculated as an estimate of the mean change from baseline in pulse at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||beats/minute||Standard Error|Least Squares Mean
114163|NCT00700817|Secondary|Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78|Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmHg||Standard Deviation|Mean
114164|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
114165|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
114166|NCT00700817|Secondary|Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78|Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmHg||Standard Deviation|Mean
114167|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52|Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
114168|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26|Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmHg||Standard Error|Least Squares Mean
114169|NCT00700817|Secondary|Mean Change in Waist Circumference From Week 52 to Week 78|Mean change in Waist Circumference from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||kg||Standard Deviation|Mean
114170|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 52|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||participants||Standard Error|Least Squares Mean
114172|NCT00700817|Secondary|Mean Change in Waist to Hip Ratio From Week 52 to Week 78|Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||cm/cm||Standard Deviation|Mean
114173|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 52|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||cm/cm||Standard Error|Least Squares Mean
114174|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 26.|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||cm/cm||Standard Error|Least Squares Mean
114175|NCT00700817|Secondary|Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.|Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage point||Standard Error|Least Squares Mean
114176|NCT00700817|Secondary|Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||pg/mL||Standard Error|Least Squares Mean
114177|NCT00700817|Secondary|Mean Change From Baseline in Adiponectin at Week 26.|Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mcg/mL||Standard Error|Least Squares Mean
114178|NCT00700817|Secondary|Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||pmol/L||Standard Error|Least Squares Mean
114179|NCT00700817|Secondary|Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.|Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||pg/mL||Standard Error|Least Squares Mean
114180|NCT00700817|Secondary|Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.|Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||U/L||Standard Error|Least Squares Mean
114181|NCT00700817|Secondary|Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26|Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mg/L||Standard Error|Least Squares Mean
114182|NCT00700817|Secondary|Mean Change in Apolipoprotein B From Week 52 to Week 78|Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114183|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 52|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||g/L||Standard Error|Least Squares Mean
114184|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 26|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||g/L||Standard Error|Least Squares Mean
114185|NCT00700817|Secondary|Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78|Mean change in free fatty acids (FFA) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114186|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114187|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114188|NCT00700817|Secondary|Mean Change in Triglycerides (TG) From Week 52 to Week 78|Mean change in triglycerides (TG) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114306|NCT00700102|Secondary|Progression Free Survival: Time to Event||within 6.5 years|Unstratified intention to treat population||Months||Full Range|Median
115642|NCT00686712|Secondary|Body Mass Index Change From Baseline||6 months||||||
114189|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 52|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114190|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 26|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114191|NCT00700817|Secondary|Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78|Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114192|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114193|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114194|NCT00700817|Secondary|Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78|Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114195|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114196|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114197|NCT00700817|Secondary|Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78|Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114198|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114199|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114200|NCT00700817|Secondary|Mean Change in Total Cholesterol From Week 52 to Week 78|Mean change in total cholesterol from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114201|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 52|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114202|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 26|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114203|NCT00700817|Secondary|Mean Change in Beta-cell Function From Week 52 to Week 78|Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||percentage point||Standard Deviation|Mean
114204|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 52|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage point||Standard Error|Least Squares Mean
114307|NCT00700102|Secondary|Participants With Progression Free Survival Event||within 6.5 years|Unstratified intention to treat population||participants|||Number
114308|NCT00700102|Secondary|Overall Survival: Months From Time of First Line Therapy||within approximately 9.6 years|||months||95% Confidence Interval|Median
114205|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 26|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage point||Standard Error|Least Squares Mean
114206|NCT00700817|Secondary|Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78|Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||mmol/L||Standard Deviation|Mean
114207|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78|Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114208|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114209|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||mmol/L||Standard Error|Least Squares Mean
114210|NCT00700817|Secondary|Mean Change in Body Weight From Week 52 to Week 78|Mean change in body weight from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||kg||Standard Deviation|Mean
114211|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 52|Calculated as an estimate of the mean change from baseline in body weight at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||kg||Standard Error|Least Squares Mean
114212|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 26|Calculated as an estimate of the mean change from baseline in body weight at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||kg||Standard Error|Least Squares Mean
114213|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||percentage of subjects|||Number
114214|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
114215|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
114216|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
114217|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||percentage of subjects|||Number
114218|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
114219|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
114220|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||percentage of subjects|||Number
114221|NCT00700817|Primary|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)||Percentage point of total HbA1c||Standard Deviation|Mean
114309|NCT00700102|Primary|Overall Survival: Time From Randomization to Death From Any Cause||within 6.5 years|Intention to treat||months||95% Confidence Interval|Median
114222|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
114223|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
114224|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
114225|NCT00700804|Primary|Calcium Absorption|Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time|17 weeks|Only participants which completed both protein diet periods were included in the statistical analysis||percentage of Calcium absorbed||Standard Deviation|Mean
114226|NCT00700804|Secondary|Serum Insulin-like Growth Factor 1 (IGF-1)||7 weeks|||nanomoles per liter (nmols/L)||Standard Error|Geometric Mean
114227|NCT00700752|Primary|Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).|Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.|after 4 weeks of lens wear|||Units on a scale||Standard Error|Least Squares Mean
114228|NCT00700739|Secondary|Device Related Adverse Events|The proportion of subjects with device related adverse events as reported throughout the duration of the study.|Intra-operatively to 24 months post-operative|||Percentage of subjects|||Number
114229|NCT00700739|Secondary|Cervical Range of Motion Measured Radiographically at 6 Months|Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.|6 months|Only 2 subjects in the cTDR and 2 subjects in the ACDF treatment groups were available for this outcome measure.||degrees||Standard Deviation|Mean
114230|NCT00700739|Secondary|Foraminal Height Measured Radiographically at 24 Months|Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).|24 months|The study was terminated prior to 24 months therefore there are no results for this endpoint.|||||
114231|NCT00700739|Secondary|Maintenance of Disc Height Measured Radiographically at 6 Months|Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).|6 months|Only 2 subjects in the cTDR and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.||mm||Standard Deviation|Mean
114232|NCT00700739|Secondary|Adjacent Level Degeneration Measured Radiographically at 24 Months|Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.|24 months|Study was terminated prior to 24 months therefore there are no results for this endpoint.|||||
114233|NCT00700739|Secondary|Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months|Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.|6 months|Only 2 subjects in the Cervical Total Disc Replacement (cTDR) and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.||degrees||Standard Deviation|Mean
114234|NCT00700739|Secondary|Work Status Assessed at 12 Months|The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 12 subjects in the ACDF treatment groups were available for this outcome.||Percentage of Subjects|||Number
114235|NCT00700739|Secondary|Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months|The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||Percentage of Subjects|||Number
114236|NCT00700739|Secondary|Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
114310|NCT00700063|Primary|Complete Clearance Rate of AK Lesions;|Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area|Day 57|||participants|||Number
114237|NCT00700739|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
114238|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 17 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
114239|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
114240|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
114241|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
114242|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.||units on a scale||Standard Deviation|Mean
114243|NCT00700739|Primary|Overall Patient Success|Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.|12 months|Overall Patient Success is composed of several outcome measures, some of which require a valid pre-operative and 12-month post-operative score. Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for the Overall Patient Success calculation.||Percentage of subjects|||Number
114244|NCT00700713|Other Pre-specified|Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.||Percentage of participants|||Number
114245|NCT00700713|Other Pre-specified|Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
114246|NCT00700713|Primary|Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
114247|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 2|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
114248|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
114249|NCT00700635|Secondary|Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
114250|NCT00700635|Secondary|Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Percentage of Participants|||Number
114251|NCT00700635|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.||Percentage of Participants|||Number
114252|NCT00700622|Primary|Change From Baseline in HbA1c to Week 16|Change from Baseline in glycosylated hemoglobin at Week 16|Baseline to Week 16|Intent to Treat with Available Data at Week 16||percentage of total hemoglobin||Standard Error|Least Squares Mean
114253|NCT00700570|Secondary|Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was to be confirmed at a minimum of 4 weeks after the first documented response. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, as well as no new target lesions. Disease progression or PD was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Non-evaluability for tumor assessment was also documented when applicable. The percentage of participants with each level of response was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
114254|NCT00700570|Secondary|Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was confirmed at a minimum of 4 weeks after the first documented response. The percentage of participants with confirmed CR or PR was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.||percentage of participants|||Number
114255|NCT00700570|Secondary|Time to Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Time to disease progression was defined as the time from first dose to time of disease progression. Participants without progression were censored at the time of last tumor assessment. Time to disease progression was estimated using Kaplan-Meier analysis and expressed in months.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)|ITT Population.||months||95% Confidence Interval|Median
114256|NCT00700570|Secondary|Percentage of Participants With Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20 percent (%) increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])|ITT Population.||percentage of participants|||Number
114257|NCT00700570|Primary|Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases|Participants were assessed via microscopic and macroscopic examination for tumor resectability after completion of 5 cycles of neoadjuvant treatment. Unresectable participants exhibited any of the following criteria: greater than or equal to (≥) 4 liver metastases; location and/or distribution of metastatic disease within the liver considered unsuitable for resection with clear margins; liver involvement precluding resection, in the setting of adequate parenchymal volume for otherwise viable liver function in the immediate postoperative period; and inability to maintain adequate circulation for viable liver function. Participants who had not met any of the above criteria at the end of 5 cycles underwent surgical resection. The percentage of participants with conversion from initially unresectable to resectable liver metastases was calculated as [number of participants eligible for surgical resection divided by the number analyzed] multiplied by 100.|After 5 cycles of neoadjuvant treatment (10 weeks)|ITT Population.||percentage of participants|||Number
114258|NCT00700440|Secondary|1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival||5 year||||||
115643|NCT00686712|Secondary|Frequency of Severe Hypoglycemic Reactions||6 months||||||
114259|NCT00700440|Primary|3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy|"The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.~Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria."|3 months|||participants with loco-regional control|||Number
114260|NCT00700427|Secondary|Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49|The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state “worse than dead.” A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
114261|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|BRIEF-A:Informant is a 75-item third-party observer’s view of the participants’ executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
114262|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
114263|NCT00700427|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49|CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
114264|NCT00700427|Secondary|Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49|The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
114265|NCT00700427|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49|The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.|Baseline (Week 24), Week 49|All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
114266|NCT00700427|Secondary|Number of Days Until Relapse|"Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.~CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants)."|Baseline (Week 24) up to Week 49|Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).||days||Standard Deviation|Mean
114267|NCT00700427|Primary|Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period|Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.|Baseline (Week 24) up to Week 49|Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).||percentage of responders|||Number
114268|NCT00700401|Secondary|Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48|Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.|Baseline, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.||Percent change||Standard Error|Mean
114269|NCT00700401|Secondary|Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48|Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.|At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.||Percent change||Standard Error|Mean
114270|NCT00700401|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 48 weeks|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||participants|||Number
114271|NCT00700401|Secondary|Percentage of Participants With Positive Predictive Value|Positive predictive value is defined as participants with RVR who did not achieve SVR.|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis.||percentage of participants||95% Confidence Interval|Number
114272|NCT00700401|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.|At week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
114273|NCT00700401|Secondary|Percentage of Participants With Virological Response at Week 24|Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).|At Week 24|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
114274|NCT00700401|Secondary|Percentage of Participants With Rapid Virological Response at Week 4|Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.|At Week 4|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
114275|NCT00700401|Primary|Percentage of Participants With Sustained Virological Response at Week 48|Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
114276|NCT00700375|Primary|Occurrence of Contrast-induced Nephropathy|The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.|after procedure and 1,2-3day after procedure|||participants|||Number
114277|NCT00700310|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set||Percent Change||Full Range|Median
114278|NCT00700310|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set.||Percentage of Participants|||Number
114279|NCT00700310|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase.||Percent Change||Full Range|Median
114280|NCT00700271|Secondary|Percentage of Participants With Controlled Office Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) at Endpoint|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for 5 minutes; the investigator then took 3 blood pressure and 1 pulse rate reading. The measurements were recorded at 1-2 minute intervals. BP Control is defined as msSBP/msDBP <149/90 mmHg and/or <130/80 mmHg if diabetes or renal insufficiency (RI).|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of participants|||Number
114281|NCT00700271|Secondary|Percentage of Participants With Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 120/70 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of participants|||Number
114282|NCT00700271|Secondary|Percentage of Participants With Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 135/85 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of Participants|||Number
114283|NCT00700271|Secondary|Percentage of Participants With 24-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) < 125/80 mmHg at Endpoint With Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken.|Visit 4 (week 8)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||Percentage of Participants|||Number
114284|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week -4 to Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Screening visit (Week -4, prior to 4-week open-label screening phase) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Mean
114285|NCT00700271|Secondary|Mean Seated Systolic Blood Pressure (msSBP)/Mean Seated Diastolic Blood Pressure (msDBP) Variation Between Week 0 and Week 8 in Office Blood Pressure|At each of the office visits, blood pressure was recorded in the morning between 08.00 and 11.00, before any antihypertensive treatment was taken. The patient remained in a sitting position for five minutes; the investigator then took three blood pressure and one pulse rate reading. The measurements were recorded at 1-2 minute intervals. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
114286|NCT00700271|Secondary|Absolute Reduction From Baseline in 6-hour Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
115644|NCT00686712|Secondary|Frequency of Total Hypoglycemic Reactions||6 months||||||
114287|NCT00700271|Secondary|Absolute Reduction From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
114288|NCT00700271|Secondary|Absolute Reduction From Baseline in Nocturnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
114289|NCT00700271|Secondary|Absolute Reduction From Baseline in Diurnal Mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
114290|NCT00700271|Primary|Absolute Reduction From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) on Ambulatory Blood Pressure Monitoring|Ambulatory Blood Pressure Monitoring (ABPM) over a 30-hour period was carried out in all patients at two visits during the study, 72 hours before visit 2 (baseline) and visit 4 (week 8). ABPM for visit 2 was carried out prior to randomization and the first dose of the amlodipine/valsartan combination study therapy. ABPM for visit four began after 12 weeks of treatment and before the last office blood pressure was taken. Covariates included baseline level, country, up-titration + treatment*country and treatment*up-titration interactions in case statistically significant at a 0.10 level.|Baseline (Week 0, after completion of screening period) and Week 8 (after 8 weeks of combination therapy)|The Intent-to-treat (ITT) population included all patients randomized and treated in the study and for whom two Ambulatory Blood Pressure Monitoring (ABPM) evaluations are available.||mmHg||Standard Error|Least Squares Mean
114291|NCT00700180|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to death due to any cause, or to end of study|ITT Population.||months||95% Confidence Interval|Median
114292|NCT00700180|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Overall Survival was estimated using the Kaplan-Meier method.|Baseline, weekly to 28 days after last dose of study treatment, every 8 weeks thereafter to death due to any cause|ITT population.||percentage of participants|||Number
114293|NCT00700180|Secondary|Duration of Response - Time to Event|The median time, in months, from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR). Median Duration of Response was estimated using the Kaplan-Meier method.|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|ITT population: only participants with an objective tumor response (CR or PR) were included in the analysis.||months||95% Confidence Interval|Median
114294|NCT00700180|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response is defined as time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death due to any cause. Participants without an event (documented progression or death) were censored at the date of last follow-up for progression. Duration of response was only calculated for participants who had a confirmed objective tumor response (CR or PR).|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT population; only participants with an objective tumor response (CR or PR) were included in the analysis.||percentage of participants|||Number
114311|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
115645|NCT00686712|Secondary|Frequency of Glucose Readings < 130 mg/dL||6 months||||||
115646|NCT00686712|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)||Percent||Standard Deviation|Mean
114295|NCT00700180|Secondary|Percentage of Participants With Measurable Disease at Baseline Who Achieved CR, PR, or Stable Disease (SD) for at Least 6 Weeks|Percentage of participants with measurable disease at baseline who on assessment achieved CR, PR, or SD according to RECIST. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met. For participants with SD, follow-up assessments must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population||percentage of participants||95% Confidence Interval|Number
114296|NCT00700180|Secondary|Percentage of Participants With Objective Response|Percentage of participants with CR or PR according to RECIST criteria. Per RECIST v1.0: CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses were confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, Day 21 of Cycles 2, 4, and 6, Day 21 of Cycles 7, 8, 9, and 10, Day 21 of every other cycle, and at disease progression|ITT Population. Data for 12 participants (3 at 7.5 mg and 9 at 15 mg) were excluded for reasons including but not limited to: no study treatment (ST), no postbaseline tumor assessment (TA), non-protocol defined antineoplastic therapy before first TA, first TA >70 days after last dose of last ST, last TA less than (<) 42 days from start of therapy.||percentage of participants||95% Confidence Interval|Number
114297|NCT00700180|Secondary|Progression-Free Survival - Time to Event|PFS was defined as the time between randomization and disease progression or death due to any cause. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization. Disease progression was evaluated according to the RECIST using CT scans, MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method.|Baseline, Day 1, weekly to disease progression|ITT Population.||months||95% Confidence Interval|Median
114298|NCT00700180|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was defined as the time between randomization and progressive disease (PD) according to RECIST criteria, or death due to any cause. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. Disease progression was evaluated according to the RECIST using computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination. Participants without an event were censored at the date of last follow up for progression. Participants with no post baseline follow-up for progression were censored at the day of randomization.|Baseline, Day 1, weekly to disease progression|ITT population.||percentage of participants|||Number
114299|NCT00700180|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Dichotomized Baseline Plasma Marker Level|Overall response was analyzed and correlated within dichotomized (low- and high-level) baseline plasma biomarker (basic fibroblast growth factor [bFGF], E-selection, intracellular adhesion molecule [ICAM], placental growth factor [PlGF], vascular endothelial growth factor A [VEGF A], vascular endothelial growth factor receptor [VEGFR]-1, and VEGFR-2) subgroups: low-level equals (=) less than or equal to (≤) median baseline level, high-level=greater than (>) median baseline level. Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.0 CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease; no new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after criteria for response were first met|Baseline, Day 21 of Cycles 2, 4, and 6 (Bv + chemo), Day 21 of Cycles 7, 8, 9, and 10 (Bv), Day 21 of every other cycle (Bv), and at disease progression.|Biomarker Evaluable Protein Plasma (BEP) Population: Participants in the ITT population who started at least 1 dose of bevacizumab and had a non-missing baseline biomarker level determined for at least 1 biomarker. n (number) equals (=) number of participants assessed for the specified biomarker.||percentage of participants|||Number
114300|NCT00700141|Secondary|Pharmacoeconomic Benefits as Assessed by the Surgeon|Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)|peri- and post-surgery until hospital discharge|"All 482 patients included and treated with TachoSil®, missing values not imputed.~Multiple answers possible."||participants|||Number
114301|NCT00700141|Primary|Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales|Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)|after surgery|"All 482 patients included and treated with TachoSil® [= Intention to Treat population (ITT)], missing values not imputed.~For one patient missing information in all three scales (Handling, Utility and Satisfaction in the Operation)"||Units on a scale||Standard Deviation|Mean
114302|NCT00700115|Primary|Plasma Viral Loads (HIV-1 RNA PCR)|Percentage subjects with undetectable Plasma viral loads|baseline to week 48|||percentage of subjects||95% Confidence Interval|Number
114303|NCT00700115|Secondary|To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects||48 weeks|intention to treat||mg/dL||Standard Error|Mean
114304|NCT00700102|Secondary|Response Rate: Participants With Response Status Based on RECIST Criteria|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 6.5 years|Participants with measurable disease||percentage of participants||95% Confidence Interval|Number
114305|NCT00700102|Secondary|Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria||within 6.5 years|Participants with measurable disease||percentage of participants||95% Confidence Interval|Number
114312|NCT00700063|Primary|Incidence of Scarring Following Study Medication Application|The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
114313|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
114314|NCT00700063|Primary|Incidence of Hypopigmentation Following Study Medication Application|The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
114315|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
114316|NCT00700063|Primary|Incidence of Hyperpigmentation Following Study Medication Application|The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
114317|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.~The actual value and change from baseline in the composite LSR score were also summarized."|Day 57|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||units on a scale||Standard Deviation|Mean
114318|NCT00700063|Primary|Incidence Rate and Severity of LSRs Following Study Medication Application|"The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.~The actual value and change from baseline in the composite LSR score were also summarized."|Baseline|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||scores on a scale||Standard Deviation|Mean
114319|NCT00700063|Primary|Incidence of SAE Recorded Throughout the Study|Incidence of SAE recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
114320|NCT00700063|Secondary|Efficacy (Clearance of AK Lesions) Partial Clearance Rate|Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp|57 days|||participants|||Number
114321|NCT00700063|Primary|Incidence of AEs Recorded Throughout the Study|Incidence of AEs recorded throughout the study|57 days|One patient in the PEP005 Topical Gel 0.005% group received no dose of study medication and were therefore not included in the safety population.||participants|||Number
114322|NCT00700011|Primary|To Determine the Non-hematologic Toxicity Profile of This Dose Schedule (Grade 2 and Above)|Assess for adverse events in all the patients receiving the Clofarabine at the dose schedules described in the protocol (CTCAE 3.0 used).|biweekly for duration of treatment , an average of 3 months|All participants considered.||participants|||Number
114323|NCT00700011|Primary|Determine Frequency and Duration of Bone Marrow Responses to IV Clofarabine|The International Working Group response criteria was used. Complete remission is defined as <5 % marrow blasts without evidence of dysplasia and normalization of the peripheral blood counts, including hemoglobin >11 g/dL, neutrophil count of >1 x 10^9/L. and platelet count of >100 x 10^9/L. Patients must also be transfusion-independent and not require any recombinant erythropoietin. Partial remission (PR) is defined as: satisfying complete remission criteria if abnormal before treatment, except that blasts are reduced by 50% or more compared to pretreatment levels, but still >5 %. Stable disease is defined as: failure to achieve at least a PR but without evidence of disease progression for at least 8 weeks.Progression of disease is defined as: disease progression with worsening cytopenias. Best response of these patients is used in the determination for this outcome below.|2-3 months|All patients considered except one on the 5 mg/m2 arm who we didn't have enough time to assess response as he died within 2 weeks after receiving cycle 1.||participants|||Number
114324|NCT00700011|Secondary|Number of Participants With DNA Hypomethylation During the Study|Since we previously observed decreases in DNA methylation in tumor cells after in vitro treatment with Clofarabine, we compared the long interspersednuclear element-1 methylation of genomic DNA obtained from CD3-depletedperipheral blood mononuclear cells between day 1 and day 5 of each cycle of Clofarabine.|assessed twice per cycle|All participants were considered except one patient on 5 mg/m2 arm who died within 2 weeks after cycle 1, so this was unassessable.||participants|||Number
114325|NCT00700011|Primary|Improvement in Peripheral Blood Count and Reduction in Number of Transfusions|Hematologic improvement will be an increased Hemoglobin of 1.5 g/dL or a reduction in the need for PRBC transfusions by at least 4 units over an 8 week period, at least 100% increase and an ANC of >0.5 x 10^9/L and an absolut platelet count increase of >30 x 10^9/L for patients who start at > 20 x 10^9/L, or increase from <20 x 10^9/L to >20 x 10^9/L and by at least 100%.|2-3 months|All patients considered for analysis except for one on the 5 mg/m2 arm who died within 2 weeks after cycle one making this unassessable for that patient.||participants|||Number
114326|NCT00699998|Secondary|Summary of All Deaths|All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module.|Randomization through end of study (30-month visit)|All randomized participants||participants|||Number
114327|NCT00699998|Secondary|Economic and Quality of Life Outcomes|Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life.|Baseline and follow-up (24 months)|All randomized participants (combined <75 years and 75 years and older) with SAQ data.||units on a scale||Standard Deviation|Mean
114328|NCT00699998|Secondary|Genotyping Related to Drug Metabolism|Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100.|Baseline|All randomized participants who provided a DNA sample.||percentage participants with geneotype|||Number
114329|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)|C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and Month 6|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months.||milligrams per liter (mg/L)||Standard Error|Geometric Mean
114330|NCT00699998|Secondary|Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 6 Months|All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months.||picograms per milliliter (pg/mL)||Standard Error|Geometric Mean
114331|NCT00699998|Secondary|Platelet Aggregation Measures|Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization.|Day 30 and 12 Months|All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12.||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
114332|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke|The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
114333|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
114334|NCT00699998|Secondary|Percentage of Participants With a Composite Endpoint of CV Death and MI|The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
114335|NCT00699998|Primary|Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke|The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|Randomization through end of study (30-month visit)|All randomized participants||percentage of participants with an event|||Number
114336|NCT00699972|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. One subject in Arm 3 was treated for 1 day prior to being excluded.||Percent Change||Full Range|Median
114337|NCT00699972|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. One subject in Arm 3 was treated for 1 day prior to being excluded.||Percentage of Participants|||Number
114338|NCT00699972|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase. One subject in Arm 3 was treated for 1 day prior to being excluded.||Percent Change||Full Range|Median
114339|NCT00699842|Secondary|Safety With Dose Escalation|Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.|2 years||||||
114340|NCT00699842|Primary|Determine CR, PR, and Rate of Stable Disease in MDS Patients|Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in >10mg doses of lenalidomide|2 years||||||
114341|NCT00699816|Secondary|Cancer-specific Survival Rate|Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||percentage of participants|||Number
114342|NCT00699816|Secondary|Overall Survival(OS) Rate|Overall survival rate was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||percentage of participants|||Number
114343|NCT00699816|Primary|Recurrence Free Survival(RFS) Rate|RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||percentage of participants|||Number
114344|NCT00699816|Secondary|Cancer-specific Survivals|Cancer-specific survival was measured from the date of randomization until death resulting from HCC.|Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||months||95% Confidence Interval|Median
114345|NCT00699816|Secondary|Overall Survival(OS)|Overall survival was measured from the date of randomization until death from any cause.|Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||months||95% Confidence Interval|Median
114346|NCT00699816|Primary|Recurrence Free Survival(RFS)|RFS was measured from the date of randomization to the first recurrence or to death from any cause.|Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)|||months||95% Confidence Interval|Median
114347|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Follow-up Visit 8 (Week 139)|The ITT population was all randomized subjects with with EQ-5D analyzed.||Participants|||Number
114348|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Week 24|The ITT population was all randomized subjects with with EQ-5D analyzed.||Participants|||Number
114349|NCT00699751|Other Pre-specified|Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16|The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’).|Week 16|The ITT population was all randomized subjects with with EQ-5D analyzed.||Participants|||Number
114350|NCT00699751|Other Pre-specified|Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114384|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at Week 12|ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either >/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
114351|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy – General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114352|NCT00699751|Other Pre-specified|Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114353|NCT00699751|Other Pre-specified|Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).|At Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114354|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.|At Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114355|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.|At Week 24|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114356|NCT00699751|Other Pre-specified|Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 – Not at all; 4 – Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.|At Week 16|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114357|NCT00699751|Other Pre-specified|Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114358|NCT00699751|Other Pre-specified|Absolute Scores for Functional Assessment of Cancer Therapy – Prostate (FACT-P) Trial Outcome Index (TOI)|The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).|Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)|The ITT population was all randomized subjects||Scores on a scale||Full Range|Median
114359|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 24|Participants in The ITT population and with ECOG analyzed||Participants|||Number
114434|NCT00699348|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 52|Safety population.||participants|||Number
114360|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 16|Participants in The ITT population and with ECOG analyzed||Participants|||Number
114361|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 8|Participants in The ITT population and with ECOG analyzed||Participants|||Number
114362|NCT00699751|Other Pre-specified|Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.|ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.|Week 0|Participants in The ITT population and with ECOG analyzed||Participants|||Number
114363|NCT00699751|Secondary|Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline|ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.|From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114364|NCT00699751|Secondary|Time to Occurrence of First Start of Any Other Anti-cancer Treatment|The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114365|NCT00699751|Secondary|Time to Occurrence of First Spinal Cord Compression|The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first spinal cord compression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114366|NCT00699751|Secondary|Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention|The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114367|NCT00699751|Secondary|Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral|The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114368|NCT00699751|Secondary|Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms|The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first use of radioisotopes until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114369|NCT00699751|Secondary|Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms|The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first EBRT until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114370|NCT00699751|Secondary|Time to First Skeletal Related Event (SRE)|A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.|From randomization to first first SRE until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114371|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period|PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of [(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to End of Treatment (Week 24; 4 weeks post last injection)|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
114372|NCT00699751|Secondary|Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA level was measured in subject’s blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
114373|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in PSA up to Week 12|PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of [(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline up to Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
114374|NCT00699751|Secondary|Percentage Change From Baseline in PSA at Week 12|PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percent change||Standard Error|Least Squares Mean
114375|NCT00699751|Secondary|Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
114376|NCT00699751|Secondary|Percentage of Participants With PSA Response at Week 12|PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
114377|NCT00699751|Secondary|Time to Prostate Specific Antigen (PSA) Progression|The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first PSA progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects||Months||95% Confidence Interval|Median
114378|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment|ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of [(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline During the 24 Week Treatment|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
114379|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percent change||Standard Error|Least Squares Mean
114380|NCT00699751|Secondary|Maximum Percentage Decrease From Baseline in Total ALP up to Week 12|ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of [(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.|From baseline to Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
114381|NCT00699751|Secondary|Percentage Change From Baseline in Total ALP at Week 12|ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)*100|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage change||Standard Error|Least Squares Mean
114382|NCT00699751|Secondary|Percentage of Participants With Total ALP Normalization at Week 12|The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.|At Baseline and Week 12|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
114383|NCT00699751|Secondary|Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)|ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.|At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)|Participants in The ITT population and had no missing values for this outcome measure||Percentage of participants|||Number
114385|NCT00699751|Secondary|Time to Total Alkaline Phosphatase (ALP) Progression|The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later|From randomization to first ALP progression until approximately 3 years after start of enrollment|The ITT population was all randomized subjects.||Months||95% Confidence Interval|Median
114386|NCT00699751|Primary|Overall Survival|Overall survival was defined as the time from date of randomization to the date of death.|From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)|The intent-to-treat (ITT) population was defined as all randomized subjects.||Months||95% Confidence Interval|Median
114387|NCT00699699|Secondary|Patients' Satisfaction After 6 Weeks of Treatment|"Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment (very satisfied, satisfied, rather satisfied, neither satisfied nor unsatisfied, rather unsatisfied, unsatisfied, and very unsatisfied)"|6 weeks|There were 1260 patients who had evaluable PGE after 6 weeks||Participants|||Number
114388|NCT00699699|Secondary|Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety|"Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications poor (1, 2), satisfactory (3, 4), good (5, 6), and excellent (7, 8))"|Baseline and after 6 weeks of treatment|There were 1260 patients who had evaluable PGE at both baseline and after 6 weeks||PGE scale points||Standard Deviation|Mean
114389|NCT00699699|Secondary|Change From Baseline in the PF-10 Score After 6 Weeks|Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks||PF-10 score points||Standard Deviation|Mean
114390|NCT00699699|Primary|Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks|Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)|Baseline and after 6 weeks of treatment|There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks||Percentage of participants|||Number
114391|NCT00699660|Secondary|Resource Utilization|time spent administering the exam|same day|||minutes||Standard Deviation|Mean
114392|NCT00699660|Secondary|Patient Satisfaction|Mean score on satisfaction survey rating scale from 1 to 5 (higher)|post-exam, same day|||units on a scale||Standard Deviation|Mean
114393|NCT00699660|Secondary|PTSD Diagnosis|Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).|Post-exam, same day|||participants|||Number
114394|NCT00699660|Secondary|PTSD Diagnosis|Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms(unable to determine accuracy of clinician diagnosis).|post-exam, same day||||||
114395|NCT00699660|Primary|Completeness and Quality of PTSD Interview|total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment|Post-exam, same day|||percentage of criteria PTSD assessment||Standard Deviation|Mean
114396|NCT00699608|Secondary|Coordination Score, as Assessed by the Linear Analogue Rating Scales|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Dizziness and Clumsiness scores are averaged to derive an overall “Coordination” score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||points on a scale||Standard Error|Least Squares Mean
114397|NCT00699608|Secondary|Mood Score, as Assessed by the Linear Analogue Rating Scales|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Anxiety, Depression, Relaxed, and Sadness scores are averaged to derive an overall “Mood” score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||points on a scale||Standard Error|Least Squares Mean
114398|NCT00699608|Secondary|Sedation Score, as Assessed by the Linear Analogue Rating Scales|The Linear Analogue Rating Scale (LARS) is used as a measure of the subjective effects of psychoactive drugs. Participants mark a series of 10 cm (100 unit line) analogue scales (1-100, 100 = most impaired) relating to dizzy, clumsy, anxious, relaxed, tired, drowsy, alert, energetic, sad, and depressed, indicating their present feeling with regard to a mid-point, representing their “usual” state of mind before treatment began. The higher the score, the more impaired the participant feels. The Tiredness, Alertness, Energy, and Drowsiness scores are averaged to derive an overall Sedation score.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||points on a scale||Standard Error|Least Squares Mean
114399|NCT00699608|Secondary|3-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||milliseconds||Standard Error|Least Squares Mean
114400|NCT00699608|Secondary|1-Back Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||milliseconds||Standard Error|Least Squares Mean
114401|NCT00699608|Secondary|3-Back Percentage of Correct Responses|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). In “3-back” tasks, a comparison is made between the current stimulus and the two before the immediately preceding stimulus. In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of “match” trials to non-match trials. The duration of the test is 2 min. The percentage of correct responses is the percentage of correct responses given in 2 min.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||percentage of responses||Standard Error|Least Squares Mean
114402|NCT00699608|Secondary|1-Back Percentage of Correct Responses|The N-Back task requires the participant to indicate, using the mouse, whether the current stimulus presented on the screen and the one immediately before it visually match (i.e., “one-back”). In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of “match” trials to non-match trials. The duration of the test is 2 minutes. The percentage of correct responses is the percentage of correct responses given in 2 minutes.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||percentage of responses||Standard Error|Least Squares Mean
114403|NCT00699608|Secondary|Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||number of substitutions||Standard Error|Least Squares Mean
114404|NCT00699608|Secondary|Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||number of substitutions||Standard Error|Least Squares Mean
114405|NCT00699608|Secondary|Critical Flicker Fusion Test–Overall Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four ascending and four descending presentations of the CFF give the overall threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||hertz||Standard Error|Least Squares Mean
114406|NCT00699608|Secondary|Critical Flicker Fusion Test –Descending Threshold|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four descending presentations from the CFF give the descending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||hertz||Standard Error|Least Squares Mean
114407|NCT00699608|Secondary|Critical Flicker Fusion Test–Ascending Threshold|Critical Flicker Fusion (CFF) is a validated cognitive assessment task that provides an index of central nervous system (CNS) activity and attention modulated motion detection. Participants are required to discriminate flicker from fusion, and vice versa, in a set of four light-emitting diodes arranged in a one-centimetre square. These diodes are held in foveal fixation when viewed at a distance of one metre. Individual thresholds are determined on four ascending and four descending scales. The mean of the four ascending presentations give the ascending threshold frequency in hertz.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||hertz||Standard Error|Least Squares Mean
114435|NCT00699348|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|PP population.||percentage of participants|||Number
114408|NCT00699608|Secondary|CTT Mean Reaction Time|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) A further outcome derived from the CTT is a peripheral awareness task where the participant responds to a stimulus presented in the periphery of vision, while simultaneously attending to the tracking test. The mean reaction time, in milliseconds, to these stimuli over the trial period is taken as the response measure for this component of the divided attention task. A lower mean reaction time is indicative of better peripheral awareness.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||milliseconds||Standard Error|Least Squares Mean
114409|NCT00699608|Secondary|Mean Tracking Error (MTE) Assessed During the CTT|Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) . The CTT is a task (8 minute duration) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the MTE, the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||pixels||Standard Error|Least Squares Mean
114410|NCT00699608|Primary|Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)|Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.|7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)|Intent-to-Treat (ITT) Population: all subjects who gave informed consent, were randomised, and received at least one dose of double-blind medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed.||pixels||Standard Error|Least Squares Mean
114411|NCT00699582|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set with Complex Partial plus Secondarily Generalized Seizures at Pre-randomization. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.||Percent Change||Full Range|Median
114412|NCT00699582|Secondary|Responder Rate|The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre‑randomization phase.|Baseline (Pre-randomization) through Week 19|Full ITT Analysis Set. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.||Percentage of Participants|||Number
114413|NCT00699582|Primary|Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-randomization) through Week 19|Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Doubleblind Phase. For Placebo arm, 2 subjects were randomized but not treated. For Perampanel 8mg arm, 1 subject was randomized but not treated.||Percent Change||Full Range|Median
114414|NCT00699491|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||months||95% Confidence Interval|Median
114415|NCT00699491|Secondary|Progression Free Survival Rate|Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.|At 6 months|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||percentage of patients||95% Confidence Interval|Number
114416|NCT00699491|Secondary|Progression Free Survival (PFS) (Phase II)|Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method.|Time from registration to documentation of disease progression, up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||months||95% Confidence Interval|Median
114417|NCT00699491|Secondary|Duration of Response (Phase II)|Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.|Up to 5 years|No patients were eligible for this endpoint.|||||
158182|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168||168 weeks|Non-completers = failure analysis||Percent of Participants|||Number
114418|NCT00699491|Secondary|Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)|Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be ‘at least possibly related to treatment’ will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported.|Up to 5 years|All patients that received protocol treatment were evaluable for this endpoint.||participants|||Number
114419|NCT00699491|Primary|Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)|"A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart.~Complete Response (CR): All of the following must be true:~Disappearance of all target and non-target lesions.~Each target lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures.~The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach."|Up to 5 years|One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.||percentage of patients with response||90% Confidence Interval|Number
114420|NCT00699491|Primary|Recommended Dose Level for Phase II Testing (RPTD) (Phase I)|"The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.~Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:~Any grade 4 hematologic toxicity~Hyperglycemia that cannot be stably controlled with diabetic medication~Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)"|During first course|Patients registered to the Phase I portion of the protocol were analyzed for this endpoint. One patient in Dose Level -1, one patient in Dose Level -2, and two patients in Dose Level -2B discontinued study treatment during Cycle 1 for reasons unrelated to toxicity and were excluded from this endpoint.||DLTs|||Number
114421|NCT00699400|Secondary|Number of Miscarriages|Number of pregnancy outcomes reported as spontaneous abortions|Anytime after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.||Number of Miscarriages|Participants||Number
114422|NCT00699400|Secondary|Number of Clinical Pregnancies|Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.|At time of ultrasound after embryo transfer|Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.||Number of Clinical Pregnancies|Participants||Number
114423|NCT00699400|Secondary|Implantation Rate|Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles|At time of ultrasound after embryo transfer|||Implantation Rate (%)|Participants|Standard Deviation|Mean
114424|NCT00699400|Secondary|Oocyte Survival Rate|Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle|At time of fertilization|||Oocyte survival rate (%)|Participants|Standard Deviation|Mean
114425|NCT00699400|Secondary|Number of Oocytes Thawed||At start of thawing cycle|||Number of oocytes thawed|Participants||Number
114426|NCT00699400|Secondary|Number of Oocytes Frozen||At cryopreservation|||Number of Oocytes Frozen|Participants||Number
114427|NCT00699400|Secondary|Number of Live Babies||Birth of one or more live babies|||Number of live births|||Number
114428|NCT00699400|Secondary|Oocyte Level Live Birth Rate|Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes|Birth of one or more live babies|||% of all oocytes thawed|Participants||Number
114429|NCT00699400|Primary|Thawing Cycle Level Live Birth Rate|Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.|Birth of one or more live babies|Live birth rate per thaw cycle(%)||% of oocytes thawed per cycle|Participants|95% Confidence Interval|Mean
114430|NCT00699374|Secondary|European Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state."|Day 1 of each cycle|Data were not collected per Amendment 2 to the protocol removing collection for this endpoint.|||||
114431|NCT00699374|Secondary|Time to Tumor Progression (TTP)|Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population||Weeks|Participants|95% Confidence Interval|Median
114432|NCT00699374|Secondary|Progression-Free Survival (PFS)|The period from randomization until disease progression or death.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population||Weeks|Participants|95% Confidence Interval|Median
114433|NCT00699374|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150|Full Analysis Population, all randomized participants where participants were classifed according to the randomized treatment arm regardless of what treatment, if any, was received.||Weeks|Participants|95% Confidence Interval|Median
114436|NCT00699348|Secondary|Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.||days||Full Range|Median
114437|NCT00699348|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|PP population.||percentage of participants||95% Confidence Interval|Number
114438|NCT00699348|Secondary|Change in Hemoglobin Concentration Between Reference SVP and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week 0 and Week 17 up to Week 24|PP Population.||g/dL||Standard Deviation|Mean
114439|NCT00699348|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants who received at least 1 dose of C.E.R.A. and for whom data for at least 1 follow-up variable was available with the exception of participants who did not fulfill the protocol specified inclusion criteria for this analysis set.||percentage of participants||95% Confidence Interval|Number
114440|NCT00699335|Secondary|Physician's Final Assessment of the Tolerability of Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
114441|NCT00699335|Secondary|Physician's Assessment of the Adhesion Properties of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
114442|NCT00699335|Primary|EQ-5D (Optional): Visual Analogue Scale|Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
114443|NCT00699335|Primary|EQ-5D (Optional): European Index Score|Index derived from the five EQ-5D-items (= mobility, self care, usual activities, pain/discomfort, anxiety/depression) resulting in a value from -1= very ill to 1=full health|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
114444|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I am not anxious or depressed~I am moderately anxious or depressed~I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)|||Units on a scale||Standard Deviation|Mean
114445|NCT00699335|Primary|EQ-5D (Optional): Domain Anxiety / Depression|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I am not anxious or depressed~I am moderately anxious or depressed~I am extremely anxious or depressed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
114446|NCT00699335|Secondary|Patient's Assessment of the Acceptance of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
114447|NCT00699335|Secondary|Physician's Assessment of the Skin Tolerability of the Fentanyl-patches|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
114448|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no pain or discomfort~I have moderate pain or discomfort~I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
114449|NCT00699335|Primary|EQ-5D (Optional): Pain / Discomfort|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no pain or discomfort~I have moderate pain or discomfort~I have extreme pain or discomfort"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
114450|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with performing my usual activities~I have some problems with performing my usual activities~I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)|||Units on a scale||Standard Deviation|Mean
114451|NCT00699335|Primary|EQ-5D (Optional): Domain Usual Activities|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with performing my usual activities~I have some problems with performing my usual activities~I am unable to perform my usual activities"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
114452|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with self-care~I have some problems washing or dressing myself~I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
114453|NCT00699335|Primary|EQ-5D (Optional): Domain Self Care|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems with self-care~I have some problems washing or dressing myself~I am unable to wash or dress myself"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
114454|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems in walking around~I have some problems in walking around~I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
114455|NCT00699335|Primary|EQ-5D (Optional): Domain Mobility|"This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D).~Questions on a scale from 1-3 at initial and final visit:~I have no problems in walking around~I have some problems in walking around~I am confined to bed"|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Participants|||Number
114456|NCT00699335|Primary|Physician's Final Assessment of the Efficacy of Therapy With Matrifen®|Assessment on a scale: Excellent, good, satisfactory, dissatisfactory|After 4 week therapy with Matrifen®|All patients included and treated, intention to treat, missing values not imputed||Participants|||Number
114457|NCT00699335|Primary|Patient's Assessment of Pain Severity Score|Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain|Before and after therapy with Matrifen® (4 weeks)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
114458|NCT00699283|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.|From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)|"The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs.~The Outcome Measure was only pre-specified for the Brivaracetam (BRV) 50 mg Arm"||percentage of subjects||95% Confidence Interval|Number
114459|NCT00699192|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||Percentage of patients|||Number
114460|NCT00699192|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)|Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|End of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||Percentage of patients|||Number
114461|NCT00699192|Secondary|Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8|A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||Percentage of patients|||Number
114473|NCT00699140|Secondary|Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)|Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1)|At any time during the study period (up to 3 months [90 days])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population only 13 responded to the treatment||days||Full Range|Median
114570|NCT00697593|Secondary|Static Physician’s Global Assessment (sPGA)|Number of subjects who achieve an Static Physician’s Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).|12 Weeks/Early Termination|Safety Population||participants|||Number
114462|NCT00699192|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.||mmHg||Standard Deviation|Mean
114463|NCT00699192|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.|Baseline to end of study (Week 8)|The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the Week 8 assessments, an LOCF (last observation carried forward) approach was used.||mmHg||Standard Deviation|Mean
114464|NCT00699153|Secondary|Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 3-18 (Each follow-up Visit 4-7)|Intent to treat population.||Composite scores||Standard Deviation|Mean
114465|NCT00699153|Secondary|Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each visit: Visit 4-7, postoperative days 3-18|Intent to treat population||participants|||Number
114466|NCT00699153|Primary|Participants With Grade 0 (no) Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative day 8 (Visit 5)|Intent to treat population||participants|||Number
114467|NCT00699153|Primary|Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative day 8 (Visit 5)|Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no.||participants|||Number
114468|NCT00699140|Secondary|Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA|The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population||seroconversions|||Number
114469|NCT00699140|Secondary|Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)|Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator’s judgment) was listed.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|Intent-to-treat population||participants|||Number
114470|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received at least one infusion with the study drug.||percentage of infusions|||Number
114471|NCT00699140|Secondary|Frequency of Adverse Reactions During and After Infusions by Percentage of Patients|All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated.|At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)|ITT population: patient who received one infusion with the study drug.||percentage of patients|||Number
114472|NCT00699140|Secondary|Regression of Hemorrhages.|"Percentage of subjects with regression of hemorrhages of Types 1 to 3:~Type 0: Patients without symptoms of bleeding at the first infusion continue without presenting spontaneous bleeding~Type 1: Patients with bleeding symptoms at the first infusion had a reduction of the size of large ecchymoses, and no spontaneous appearance of new ecchymoses~Type 2: Patients with bleeding symptoms at the first infusion had a decrease in the number of cutaneous petechiae, or the extent of the affected area of the body decreased~Type 3: Patients had active mucosal bleedings at the first infusion, these episodes stopped without re-bleeding, and there was no occurrence of new spontaneous mucosal hemorrhages (e.g., gingival bleeding, epistaxis)"|First 10 to14 days since the first infusion day (Day 1)|ITT population: patients who received at least one infusion of the study drug||percentage of subjects||95% Confidence Interval|Number
114474|NCT00699140|Secondary|Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)|The time taken for the platelet count to reach ≥ 50x10^9/L from first dose|At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population but only 13 responded to the treatment||days||Full Range|Median
114475|NCT00699140|Secondary|Maximum Platelet Level Reached During the Follow-up Period|Platelet count was measured at various time points in the follow-up period after infusion.|During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])|The maximum platelet counts were taken from the population who responded to treatment (platelet count ≥ 50x10^9/L). If any patient received banned medication due to ITP progression during the study, the values obtained after patients received treatment were excluded.||platelets x 10^-9/L||Full Range|Median
114476|NCT00699140|Primary|Responder Patients|The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.|At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).|All 18 subjects received at least one infusion (at any dose) of IGIV3I Grifols and were included in the intent-to-treat (ITT) population for efficacy and safety analysis.||percentage of subjects||95% Confidence Interval|Number
114477|NCT00698932|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24|Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||Percentage of Participants|||Number
114478|NCT00698932|Secondary|Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.||mg*min/dL||Standard Error|Mean
114479|NCT00698932|Secondary|Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.||mmol*min/L||Standard Error|Mean
114480|NCT00698932|Secondary|Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
114481|NCT00698932|Secondary|Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||mmol/L||Standard Error|Mean
114482|NCT00698932|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.||percent||Standard Error|Mean
114483|NCT00698841|Secondary|Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; LLN=lower level of normal. Laboratory values assessed using CTC for AEs, Version 3.0. Hemoglobin (g/dL) Grade 1:<LLN to 10.0, Grade 2:<10.0 to 8.0, Grade 3:<8.0 to 6.5, Grade 4:<6.5. Platelets Grade 1:LLN to 75.0*10^9/L, Grade 2:<75.0 to 50.0*10^9/L, Grade 3:<50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L. White blood cells Grade 1:<LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3:<2.0 to 1.0*10^9/L, Grade 4:<1.0*10^9/L. Neutrophils Grade 1:<LLN to 1.5*10^9/L, Grade 2:<1.5 to 1.0*10^9/L, Grade 3:<1.0 to 0.5*10^9/L, Grade 4:<0.5*10^9/L.|At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up|All participants who received at least 1 dose of cetuximab.||Participants|||Number
114484|NCT00698841|Primary|Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia’s Correction Formula (QTcF) by Study Day and Time Point|The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline.|Predose Day 1 (Baseline) to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.||msec||Standard Error|Mean
114485|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)|BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal. Sodium, low(mmol/L) Grades 1&2:<LLN–130, Grade 3:<130–120, Grade 4:<120. Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160. Potassium, high (mmol/L) Grade 1:>ULN-5.5, Grade 2:>5.5-6.0, Grade 3:>6.0-7.0, Grade 4:>7.0. Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30. Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500. Calcium, high(mg/dL) Grade 1:>ULN-11.5, Grade 2:>11.5-12.5, Grade 3:>12.5-13.5, Grade 4:>13.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab||Participants|||Number
114486|NCT00698841|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study|BL=baseline; OS=on-study; ULN=upper level of normal. Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3&4:<20. Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Total bilirubin, high Grade 1:ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-10.0*ULN, Grade 4:>10.0*ULN. Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-6.0*ULN, Grade 4:>6.0*ULN.|At screening, at the end of Cycle 1 (28 days)|All participants who received at least 1 dose of cetuximab||Participants|||Number
114487|NCT00698841|Secondary|Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. CTC Grade 1: Mild. Grade 2: Moderate. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening.|Baseline through Cycle 1 (28 days), continuously|||Participants|||Number
114488|NCT00698841|Secondary|Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment.|Baseline through Cycle 1 (28 days), continuously|All participants who received at least 1 dose of cetuximab.||Participants|||Number
114489|NCT00698841|Secondary|Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate|12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The PR interval is the time from the onset of the P wave to the beginning of the QRS complex. The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles. Clinically significant was determined at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.||Participants|||Number
114490|NCT00698841|Primary|Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline|12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.|Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)|Those who met all study criteria and did not require interrupted cetuximab infusion on Day (D)1 or 22; miss an ECG timepoint at baseline, D1, or D22; stop/modify dose of a scheduled drug that prolongs QT/QTc interval, receive other cancer therapy, begin a prohibited drug, or require cetuximab dose reduction before D29; withdraw consent before D23.||Participants|||Number
114491|NCT00698815|Secondary|Overall Survival (OS)|OS is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)|||months||95% Confidence Interval|Median
114492|NCT00698815|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 3 years)|||percentage of participants||95% Confidence Interval|Number
114493|NCT00698815|Secondary|PFS|PFS was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 3 years)|||months||95% Confidence Interval|Median
114494|NCT00698815|Primary|18 Week Progression-free Survival (PFS) Rate|The 18 week progression-free survival rate was defined as the proportion of patients that were alive and progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.|At 18 weeks|||percentage of participants||95% Confidence Interval|Number
114495|NCT00698685|Primary|Non-relapse Mortality at or Before Day 100|The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin’s disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).|Day 100 after transplant|All participants who received at least 1 day of treatment.||Participants|||Number
114496|NCT00698685|Primary|Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).|The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.|Day 100 after transplant.|All participants who completed treatment and underwent allogeneic transplant.||participants|||Number
114497|NCT00698646|Secondary|Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])||During 16 weeks|Intent to treat (ITT)||Weeks||95% Confidence Interval|Median
114498|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)|Cumulative refers to achieving blood pressure goal before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)||Percentage of Participants|||Number
114499|NCT00698646|Secondary|Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg|Cumulative refers to achieving of blood pressure control before or at the corresponding visit.|Weeks 4, 8, 12 and 16|Intent to treat (ITT)||Percentage of Participants|||Number
114500|NCT00698646|Secondary|Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Weeks 8, 12, and 16|Intent to treat (ITT), Last observation carried forward||mm Hg||Standard Deviation|Mean
114501|NCT00698646|Secondary|Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Weeks 4, 8, 12 and 16|Intent to treat (ITT), Last observation carried forward||mm Hg||Standard Deviation|Mean
114502|NCT00698646|Primary|Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward||mm Hg||Standard Deviation|Mean
114503|NCT00698581|Secondary|The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.||Participants|||Number
114504|NCT00698581|Secondary|The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.||Participants|||Number
114505|NCT00698581|Secondary|The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.||Participants|||Number
114506|NCT00698581|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase|"The percentage of subjects meeting at least one of four Exit criteria are presented below.~The primary analysis is only conducted on the Brivaracetam 50 mg/day group."|From Week 1 up to Week 17|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.||percentage of subjects|||Number
114507|NCT00698516|Secondary|Overall Survival|Overall survival is defined as the time from initiation of investigational product to death due to any cause. For participants who did not die, the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||weeks||95% Confidence Interval|Median
114508|NCT00698516|Secondary|Time to Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Time to response is defined as the time from initiation of investigational product to the time of first documented response (CR or PR).|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR||weeks||95% Confidence Interval|Median
114509|NCT00698516|Secondary|Duration of Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. Duration of response is defined as the time from start of response (CR or PR) until progression or death due to any cause. For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|Participants from the ITT Population who had CR and PR||weeks||95% Confidence Interval|Median
114510|NCT00698516|Secondary|Number of Participants With a Tumor Response (CR and PR)|Tumor response was determined using the RECIST guidelines. CR: disappearance of all target lesions. PR: >=30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||participants|||Number
114511|NCT00698516|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|Tumor response was determined using the RECIST guidelines.CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since treatment started; PD, >=20% increase in sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||participants|||Number
114512|NCT00698516|Secondary|PFS - Overall|Progression-free survival at any site was defined as the time from initiation of investigational product to the time of first documented disease progression or death due to any cause. Progression was assessed using the RECIST guidelines: >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion (s). For participants who did not progress or die, the time of initiation of post-treatment anti-cancer therapy or the time of last contact was used.|Baseline to disease progression or death (up to 82.4 weeks)|ITT Population||weeks||95% Confidence Interval|Median
114513|NCT00698516|Primary|Percentage of Participants With Progression-free Survival (PFS) at 3 Months|PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): >=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.|3 months|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication||percentageof participants|||Number
114514|NCT00698451|Secondary|The Secondary Efficacy Endpoints is Duration of Objective Response.|Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.|ITT||Days||Full Range|Median
114515|NCT00698451|Primary|The Primary Efficacy End Point is the Number of Patients With an Objective Response.|Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)|ITT||Participants|||Number
114516|NCT00698204|Secondary|Evaluation of Pain Severity at 5000 cGy Radiation|Mean worst pain at 5000 cGy on 0-10 scale, 0 = no pain, 10 = worst pain imaginable|5 weeks from start of radiation therapy (cumulative dose of 5000 cGy)|Only subjects who were still taking the study drug (celecoxib or placebo) when cumulative radiation dose of 5000 cGy was reached are included in this analysis (19 of 20 in each group were analyzed).||units on a scale||Standard Deviation|Mean
114517|NCT00698204|Primary|Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy|"Oral Mucositis Assessment Scale (OMAS) was used to assess oral mucosal injury during the period of radiation therapy. This validated scale scores ulceration and erythema independently at nine specified sites in the oral cavity. Ulceration is scored from 0-3 based on size of lesion and erythema is scored from 0-2 based on severity of erythema. The sum of scores is then divided by 9.~The mean OMAS score at a cumulative radiation dose of 5000 cGy (approximately 5 weeks of treatment) was compared between groups."|5 weeks from start of radiation therapy (5000 cGy)|Subjects participating in the study as they reached a cumulative dose of 5000 cGy were included. One subject in the celecoxib group withdrew prior to reaching 5000 cGy.||units on a scale||Standard Deviation|Mean
114518|NCT00698139|Secondary|Changes in Renin||baseline and 6 hours||||||
114519|NCT00698139|Secondary|Changes in Norepinephrine||baseline and 6 hours||||||
114520|NCT00698139|Secondary|Changes in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) was measured for all subjects to determint the difference between pre- and post-procedure.|baseline and 6 hours|||ng/L||Standard Deviation|Mean
114521|NCT00698139|Secondary|Changes in Thoracic Impedence|Impedence will be measured using the pacemaker programmer to determine the difference in thoracic impedence pre- and post-procedure.|baseline and 6 hours|||ohm||Standard Deviation|Mean
114522|NCT00698139|Primary|Change in Cardiac Output (CO)|The difference between post and pre CO|baseline and 6 hours|||L/min||Standard Deviation|Mean
114523|NCT00698035|Secondary|Change in Vaginal Epithelium Scores|During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.|Baseline, 12 weeks|Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy||units on a scale||Standard Deviation|Mean
114524|NCT00698035|Secondary|Sexual Satisfaction|"Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked Overall, how satisfactory to you is your sexual relationship with your partner? Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory)."|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at all 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)||units on a scale||Standard Deviation|Mean
114525|NCT00698035|Secondary|Sexual Quality of Life|Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.|Baseline, Week 4, Week 12|Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)||units on a scale||Standard Deviation|Mean
114526|NCT00698035|Secondary|Total Testosterone Levels|By serum ultrasensitive total testosterone test (Quest Diagnostics)|12 weeks|Per protocol, participants assigned to the Testosterone arm who completed 12 weeks of assigned treatment and had testosterone measurement at baseline, 4 weeks and 12 weeks.||ng/dl||Standard Deviation|Mean
114565|NCT00697593|Primary|Hematology - Eosinophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
114566|NCT00697593|Primary|Hematology - Neutrophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
114527|NCT00698035|Primary|Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range|Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.|12 Weeks|Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.||participants|||Number
114528|NCT00698035|Secondary|Matched E2 by Commercial and Research (RIA) Analyses|Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women|baseline, 4 weeks|Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs||pg/ml||Standard Deviation|Mean
114529|NCT00698035|Secondary|Serum Estradiol (E2)|serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)|12 weeks|Per protocol, participants who completed 12 weeks of assigned treatment||pg/ml||Standard Deviation|Mean
114530|NCT00698022|Secondary|The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers.||28 days||||||
114531|NCT00698022|Secondary|The Secondary Study Objectives Are to Determine the Mean Percent Change in Baseline Body Weight; and the Proportion of Subjects That Gain Less Than 5% and Less Than 7% of Their Baseline Body Weight in the Treatment Groups.||28 days||||||
114532|NCT00698022|Primary|Change in Weight (kg) From Baseline to Day 28.|Change in weight (kg) was compared at Baseline and Day 28 for all subjects in all treatment arms.|baseline and 28 days|||kilograms||Standard Error|Mean
114533|NCT00698009|Primary|Number of Participants Infused Haploidentical Donor-derived Natural Killer (NK) Cells and Low-dose Interleukin-2 (IL-2)|Feasibility of an infused allogeneic donor NK cell product and IL-2 following a cyclophosphamide and fludarabine preparative regimen to treat relapsed neuroblastoma after autologous peripheral blood stem cell (PBSC) transplant where feasibility is defined as being able to infuse NK cells on day 0.|21 days, up to 1 year||||||
114534|NCT00698009|Primary|Participant Disease Response|Neuroblastoma International Response Criteria: Complete Response (CR): No evidence of disease (primary and metastasis) clinically & radiographic studies, (homovanillic acid (HVA)/vanillylmandelic acid (VMA) normal). Very Good Partial Response (VGPR): >90% reduction in primary tumor, resolution all metastatic tumor except bone. No new bone lesions and improvement on scan of all pre-existing lesions; HVA/VMA decreased >90%. Partial Response (PR): 50-90% reduction primary and all measurable metastatic lesions, 0-1 bone marrow samples with tumor; scans of bone lesions same as VGPR. HVA/VMA decreased 50-90%. Mixed Response (MR): > 50% reduction any measurable disease (primary or metastases); no new lesions; <25% increase in any existing lesion (exclude bone marrow evaluation). No Response (NR): No new lesions; < 25% increase in existing lesion. Progressive Disease (PD): Any new lesions. Increase <25% in measurable lesion, previous negative bone marrow positive for tumor.|1 Year for overall patient response, or until disease progression||||||
114535|NCT00697827|Secondary|Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. There are 10 questions. The questions are designed in a way to show how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. For this study,any improvement at 24 months compared to pre-operative baseline was determined as a success.|24 months|||participants|||Number
114536|NCT00697827|Primary|Zurich Claudication Questionnaire(ZCQ)|The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of < 2.5 points for patient satisfaction at 24 months.|24 months|||participants|||Number
114537|NCT00697801|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired).|baseline, week 6|Patients with available data at specified time points are included in the analysis population.||percentage of predicted FEV1||Standard Deviation|Mean
114538|NCT00697801|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.||units on a scale||Standard Deviation|Mean
114567|NCT00697593|Primary|Hematology - White Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
114568|NCT00697593|Primary|Hematology - Red Blood Cell Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^12/L||Standard Deviation|Mean
114569|NCT00697593|Primary|Hematology - Hemoglobin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||g/L||Standard Deviation|Mean
114539|NCT00697801|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 6|Patients with available data at specified time points are included in the analysis population.||units on a scale||Standard Deviation|Mean
114540|NCT00697697|Primary|Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.||participants|||Number
114541|NCT00697697|Primary|Number of Patients With Treatment Emergent Adverse Events Related to Study Drug|A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.|40 weeks|All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.||participants|||Number
114542|NCT00697619|Primary|Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .||Baseline, the first, second and third month|||nM /mM||Standard Error|Median
114543|NCT00697593|Primary|Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis|Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above|Week 12 / Early Termination||||||
114544|NCT00697593|Primary|Urinalysis - Leukocytes Esterase|Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
114545|NCT00697593|Primary|Urinalysis - Nitrite|Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
114546|NCT00697593|Primary|Urinalysis - Blood|Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
114547|NCT00697593|Primary|Urinalysis - Glucose|Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine|Week 12 / Early Termination|Safety Population - 3 participants with missing values||participants|||Number
114548|NCT00697593|Primary|Urinalysis - Ketones|Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine|Week 12 / Early Termination|||participants|||Number
114549|NCT00697593|Primary|Urinalysis - Protein|Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine|Week 12 / Early Termination|||participants|||Number
114550|NCT00697593|Primary|Urinalysis - pH|Urine samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||pH units||Standard Deviation|Mean
114551|NCT00697593|Primary|Biochemistry - C-Reactive Protein (CRP)|Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L|Week 12 / Early Termination|Safety Population - 1 participant with missing values||participants|||Number
114552|NCT00697593|Primary|Biochemistry - Urea|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||mmol/L||Standard Deviation|Mean
114553|NCT00697593|Primary|Biochemistry - Glutamyl Transferase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||IU/L||Standard Deviation|Mean
114554|NCT00697593|Primary|Biochemistry - Alkaline Phosphatase|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||IU/L||Standard Deviation|Mean
114555|NCT00697593|Primary|Biochemistry - Alanine Transaminase (ALT)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||IU/L||Standard Deviation|Mean
114556|NCT00697593|Primary|Biochemistry - Aspartate Transaminase (AST)|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 2 participants missing values||IU/L||Standard Deviation|Mean
114557|NCT00697593|Primary|Biochemistry - Total Bilirubin|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||μmol/L||Standard Deviation|Mean
114558|NCT00697593|Primary|Biochemistry - Creatinine|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||μmol/L||Standard Deviation|Mean
114559|NCT00697593|Primary|Biochemistry - Potassium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||mmol/L||Standard Deviation|Mean
114560|NCT00697593|Primary|Biochemistry - Sodium|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 1 participant missing values||mmol/L||Standard Deviation|Mean
114561|NCT00697593|Primary|Hematology - Platelet Count|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 4 participants missing values||x10^9/L||Standard Deviation|Mean
114562|NCT00697593|Primary|Hematology - Lymphocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
114563|NCT00697593|Primary|Hematology - Monocytes|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
114564|NCT00697593|Primary|Hematology - Basophils|Blood samples were taken for clinical laboratory testing|Week 12 / Early Termination|Safety Population - 3 participants missing values||x10^9/L||Standard Deviation|Mean
114573|NCT00697541|Primary|AUC - Area Under the Curve of Brimonidine|"Area under the plasma concentration-time curve from 0 hour to the last measurable plasma concentration, calculated by the linear trapezoidal method~After two topical applications of 0.18% COL-118 facial gel, plasma levels of brimonidine for all subjects were below the LoQ (25 pg/mL), with the exception of one single outlier value.~Thus, no PK analysis could be performed for 0.18% COL-118 facial gel.~After ocular administration of 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations of brimonidine were observed in 11 of the 18 subjects who received the brimonidine tartrate ophthalmic solution. Brimonidine rapidly appeared in plasma The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects The mean AUC0-t also was not calculated."|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose|||pg*hr/mL||Full Range|Mean
114574|NCT00697541|Primary|Cmax - Maximum Systemic Concentration of Brimonidine|Maximum observed plasma concentration|0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose|||pg/mL||Full Range|Mean
114575|NCT00697515|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 7 days|SP||msec||Standard Deviation|Mean
114576|NCT00697515|Secondary|Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP||bpm||Standard Deviation|Mean
114577|NCT00697515|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|SP||mmHg||Standard Deviation|Mean
114578|NCT00697515|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|Safety Population (SP) defined as all subjects who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
114579|NCT00697515|Secondary|Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).|Baseline and 26 days|||Units on a scale||Standard Deviation|Mean
114580|NCT00697515|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase|AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).|Baseline and 26 days|EEP||Units on a scale||Standard Deviation|Mean
114581|NCT00697515|Secondary|Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase|MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.|26 days|EEP||Participants|||Number
114582|NCT00697515|Secondary|Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase|The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.|Baseline and 26 days|EEP||Units on a scale||Standard Deviation|Mean
114583|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 days|ITT||Participants|||Number
114584|NCT00697515|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7, 14, 21 and 28 days|EEP||Participants|||Number
114585|NCT00697515|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|EEP||Participants|||Number
114586|NCT00697515|Secondary|ADHD-RS With Prompts Total Score in the Crossover Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|7 days|ITT||Units on a scale||Standard Error|Least Squares Mean
114587|NCT00697515|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase|The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7, 14, 21 and 28 days|Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
114588|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT||Units on a scale||Standard Error|Least Squares Mean
114589|NCT00697515|Secondary|PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT||Units on a scale||Standard Error|Least Squares Mean
114590|NCT00697515|Secondary|PERMP Total Score by Timepoint in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|ITT||Units on a scale||Standard Error|Least Squares Mean
114591|NCT00697515|Primary|Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase|The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.|2, 4, 8, 10, 12 and 14 hours post-dose on Day 7|Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.||Units on a scale||Standard Error|Least Squares Mean
114592|NCT00697255|Secondary|Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|During In-Treatment Period (up to 14 weeks after first corifollitropin injection)|The All-Participants-Treated (APT) group consisted of all participants who received corifollitropin alfa. Participants were grouped according to the stage of the trial and the active treatment group (recFSH Stage Ia, hCG Stage Ib) they actually received.||participants|||Number
114593|NCT00697255|Secondary|Number of Participants With Pregnancy|A pregnancy test (serum or urinary hCG) was performed two to three weeks after bolus injection of hCG. In case of a positive pregnancy test vaginal and/or abdominal ultrasound scan was performed to confirm the pregnancy at 5 to 6 weeks after bolus injection of hCG and ≥10 weeks after bolus injection of hCG to confirm ongoing pregnancy.|At least 10 weeks after bolus injection of hCG (up to 13 weeks)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||participants|||Number
114594|NCT00697255|Secondary|Percentage of Participants Who Cancelled Treatment (Cancellation Rate)|Treatment was considered cancelled if no bolus injection of hCG was administrated. Reasons of treatment failure included Adverse Event (AE)/ Serious Adverse Event (SAE), insufficient ovarian response on stimulation day 13 (no follicle ≥12 mm), insufficient ovarian response after 7 days of hCG/recFSH treatment (no follicle ≥18 mm), and multifollicular growth (≥3 follicles ≥15 mm).|Up to 3 weeks after bolus injection of hCG (up to 41 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
114595|NCT00697255|Secondary|Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)|Monofollicular ovulation rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) and confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
114596|NCT00697255|Secondary|Percentage of Participants With Ovulation (Ovulation Rate)|Ovulation rate was defined as the number of participants with confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.|8 days after bolus injection of hCG (up to 28 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
114597|NCT00697255|Primary|Percentage of Participants With Monofollicular Response (Monofollicular Rate)|The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.|At day of bolus injection of hCG (up to 20 days)|Intent-to-Treat group (ITT) consisted of all treated participants (5 participants in Stage Ia and 3 participants in Stage Ib).||percentage of participants|||Number
114598|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114599|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114600|NCT00697190|Primary|Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114601|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
115904|NCT00684255|Primary|Toxicity|Toxicity associated with reduced intensity regimen of fludarabine/busulfan and Campath followed by allogeneic stem cell transplant in patients with medically refractory Systemic Lupus Erythematosus (SLE) or SSc is measured.|1 year||||||
114602|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114603|NCT00697190|Primary|Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114604|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114605|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114606|NCT00697190|Primary|Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114607|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114608|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114609|NCT00697190|Primary|Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114610|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 13 subjects that were oblique astigmats within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114611|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 14 subjects that were hyperopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114612|NCT00697190|Primary|Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)|Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.|after 6 hours of wear|There were 11 subjects that were high myopes within the total completed population of 38.||Units on a scale||Standard Error|Least Squares Mean
114613|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Radiological Abnormalities|Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
114614|NCT00697112|Secondary|Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities|Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats [RR interval]).|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
114615|NCT00697112|Secondary|Percentage of Participants With Serious Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
114616|NCT00697112|Secondary|Percentage of Participants With Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
123898|NCT00608491|Secondary|Change in Uric Acid||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
114617|NCT00697112|Secondary|Percentage of Participants With Physical Abnormalities|Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.|Baseline up to Month 12|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.||percentage of participants|||Number
114618|NCT00697112|Secondary|Body Weight||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||kilogram||Standard Deviation|Mean
114619|NCT00697112|Secondary|Pulse Rate||Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||beats per minute||Standard Deviation|Mean
114620|NCT00697112|Secondary|Blood Pressure|Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||mmHg||Standard Deviation|Mean
114621|NCT00697112|Secondary|Number of Participants With Body Temperature|Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. Results for hypothermia not reported as none of the participants was found hypothermic.||participants|||Number
114622|NCT00697112|Secondary|Body Mass Index|BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||kg/m^2||Standard Deviation|Mean
114623|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.|Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants|||Number
114624|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants|||Number
114625|NCT00697112|Secondary|Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy||Baseline up to Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants|||Number
114626|NCT00697112|Secondary|Average Proteinuria|Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||g/24 hr||Standard Deviation|Mean
114627|NCT00697112|Secondary|Average Creatinine Clearance|Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.||milliliter per minute (mL/min)||Standard Deviation|Mean
114628|NCT00697112|Secondary|Average Blood Level of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
114629|NCT00697112|Secondary|Average Dose of Immunosuppressive Drugs Administered|Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).|Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53|ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.||milligram per day||Standard Deviation|Mean
114630|NCT00697112|Secondary|Probability of Participant Survival|Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||probability of participant survival||95% Confidence Interval|Number
114631|NCT00697112|Secondary|Probability of no Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than [>] 25 percent [%] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (>25% of parenchyma affected) and severe tubulitis (>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising >25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||probability of no acute rejection||95% Confidence Interval|Number
114632|NCT00697112|Secondary|Probability of Graft Survival|Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.|Month 12|ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||probability of graft survival||95% Confidence Interval|Number
114633|NCT00697112|Primary|Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy|The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.|Baseline|Intention-to-Treat (ITT) population included all participants who were treated with Rapamune for at least 4 or 5 weeks.||percentage of participants||95% Confidence Interval|Number
114634|NCT00697073|Secondary|Nature and Frequency of Adverse Events||12 Months||||||
114635|NCT00697073|Secondary|FARS (Friedreich’s Ataxia Rating Scale)||baseline and 12 Months||||||
114636|NCT00697073|Primary|Change in ICARS|"International Cooperative Ataxia Rating Scale (ICARS):~ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.~Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 12 months|||ICARS points||Standard Deviation|Mean
114637|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 3|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||pg/mL||Standard Deviation|Mean
114638|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 2|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||pg/mL||Standard Deviation|Mean
114639|NCT00696878|Secondary|Serum Inhibin-B Levels in Treatment Cycle 1|Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||pg/mL||Standard Deviation|Mean
114640|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 3|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||nmol/L||Standard Deviation|Mean
114641|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 2|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||nmol/L||Standard Deviation|Mean
114642|NCT00696878|Secondary|Serum Progesterone Levels in Treatment Cycle 1|Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||nmol/L||Standard Deviation|Mean
116239|NCT00681538|Secondary|Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.||participants|||Number
114643|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 3|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||pmol/L||Standard Deviation|Mean
114644|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 2|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||pmol/L||Standard Deviation|Mean
114645|NCT00696878|Secondary|Serum Estradiol Levels in Treatment Cycle 1|Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||pmol/L||Standard Deviation|Mean
114646|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 3|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||IU/L||Standard Deviation|Mean
114647|NCT00696878|Secondary|Serum LH Levels in Treatment Cycle 2|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||IU/L||Standard Deviation|Mean
114648|NCT00696878|Secondary|Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1|Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||IU/L||Standard Deviation|Mean
114649|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 3|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 3||IU/L||Standard Deviation|Mean
114650|NCT00696878|Secondary|Serum FSH Levels in Treatment Cycle 2|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 2||IU/L||Standard Deviation|Mean
114651|NCT00696878|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1|Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.|Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG injection in Treatment Cycle 1||International Units (IU)/L||Standard Deviation|Mean
114652|NCT00696878|Secondary|Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy|The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa||percentage of participants|||Number
114653|NCT00696878|Secondary|Number of Participants With Ongoing Pregnancy in Any FTET Cycle|After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET within an FTET cycle|Participants who received corifollitropin alfa and had ET in any FTET cycle||participants|||Number
114654|NCT00696878|Secondary|Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3|Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.|From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had biochemical pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
158183|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168||168 weeks|Non-completers = failure analysis||U/mL||Standard Deviation|Mean
114655|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3|Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan.|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had vital pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
114656|NCT00696878|Secondary|Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3|Miscarriage: Loss of the fetus without induction or instrumentation, also known as “spontaneous abortion.” Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan.|5-6 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had clinical pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
114657|NCT00696878|Secondary|Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|10 weeks up to 9 months after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ongoing pregnancy in any of Treatment Cycles 1, 2 or 3||participants|||Number
114658|NCT00696878|Secondary|Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3|Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.|≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle|Participants who received corifollitropin alfa||participants|||Number
114659|NCT00696878|Secondary|Implantation Rate for Participants With ET|The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.|Approximately 5-6 weeks after ET, within a treatment cycle|Participants who received corifollitropin alfa and had ET||percentage of embryos||Standard Deviation|Mean
114660|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa in Treatment Cycle 3||number of embryos||Standard Deviation|Mean
114661|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa in Treatment Cycle 2||number of embryos||Standard Deviation|Mean
114662|NCT00696878|Secondary|Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1|The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa in Treatment Cycle 1||number of embryos||Standard Deviation|Mean
114663|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had ET in Treatment Cycle 3||participants|||Number
114664|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had ET in Treatment Cycle 2||participants|||Number
114665|NCT00696878|Secondary|Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1|The number of embryos transferred, for each participant, by category of number of “good quality” embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had ET in Treatment Cycle 1||participants|||Number
114666|NCT00696878|Secondary|Number of Embryos Transferred|ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.|At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had ET||number of embryos||Standard Deviation|Mean
114667|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3||number of embryos||Standard Deviation|Mean
114668|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3||number of embryos||Standard Deviation|Mean
114669|NCT00696878|Secondary|Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1|At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or “other grade”, with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of “good quality.”|Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1 and had embryo assessment at Day 3 after oocyte pick-up; excludes participants with embryo transfer or embryos cryopreserved before Day 3||number of embryos||Standard Deviation|Mean
114670|NCT00696878|Secondary|Fertilization Rate|The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa and had IVF and/or ICSI||percentage of oocytes||Standard Deviation|Mean
114671|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3||number of fertilized oocytes||Standard Deviation|Mean
114672|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2||number of fertilized oocytes||Standard Deviation|Mean
114673|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1||number of fertilized oocytes||Standard Deviation|Mean
114674|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3, and were enrolled at a site using cyropreservation at the fertilized oocyte level||number of fertilized oocytes||Standard Deviation|Mean
114675|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2, and were enrolled at a site using cyropreservation at the fertilized oocyte level||number of fertilized oocytes||Standard Deviation|Mean
114676|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1, and were enrolled at a site using cyropreservation at the fertilized oocyte level||number of fertilized oocytes||Standard Deviation|Mean
114677|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 3|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 3||number of fertilized oocytes||Standard Deviation|Mean
114678|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 2|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 2||number of fertilized oocytes||Standard Deviation|Mean
114679|NCT00696878|Secondary|Number of Fertilized Oocytes Obtained in Treatment Cycle 1|This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).|16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1|Participants who received corifollitropin alfa and had IVF and/or ICSI in Treatment Cycle 1||number of fertilized oocytes||Standard Deviation|Mean
114680|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 3||number of oocytes||Standard Deviation|Mean
114681|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 2||number of oocytes||Standard Deviation|Mean
114682|NCT00696878|Secondary|Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1|This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1|Participants who received corifollitropin alfa and were to have ICSI in Treatment Cycle 1||number of oocytes||Standard Deviation|Mean
114683|NCT00696878|Secondary|Number of Oocytes Retrieved in a Participant Among Entire Study Population|Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.|Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa||number of oocytes||Standard Deviation|Mean
158184|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 168||168 weeks|Non-completers = failure analysis||log10 copies/mL||Standard Deviation|Mean
114684|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 3||follicles||Standard Deviation|Mean
114685|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 2||follicles||Standard Deviation|Mean
114686|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.|Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1|Participants who received corifollitropin alfa and (rec)hCG, and had data for assessment of follicles ≥11 mm on day of (rec)hCG administration in Treatment Cycle 1||follicles||Standard Deviation|Mean
114687|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 3||follicles||Standard Deviation|Mean
114688|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 2||follicles||Standard Deviation|Mean
114689|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 8 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 8 in Treatment Cycle 1||follicles||Standard Deviation|Mean
114690|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 3||follicles||Standard Deviation|Mean
114691|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 2||follicles||Standard Deviation|Mean
114692|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 5 or 6 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 5 or 6 in Treatment Cycle 1||follicles||Standard Deviation|Mean
114693|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 3|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 3||follicles||Standard Deviation|Mean
114694|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 2|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 2||follicles||Standard Deviation|Mean
114695|NCT00696878|Secondary|Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1|For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.|Stimulation Day 1 in Treatment Cycle 1|Participants who received corifollitropin alfa and had data for assessment of follicles ≥11 mm on Stimulation Day 1 in Treatment Cycle 1||follicles||Standard Deviation|Mean
115005|NCT00693992|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 5 years)|||months||95% Confidence Interval|Median
114696|NCT00696878|Secondary|Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG|Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.|Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle|Participants who received corifollitropin alfa and (rec)hCG||International Unit (IU)||Full Range|Median
114697|NCT00696878|Primary|Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)|OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.|Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle|Participants who received corifollitropin alfa||participants|||Number
114698|NCT00696878|Primary|Number of Participants With Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa||participants|||Number
114699|NCT00696878|Primary|Number of Participants With AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to approximately 26 months after first dose of corifollitropin alfa|Participants who received corifollitropin alfa||participants|||Number
114700|NCT00696878|Primary|Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
114701|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
114702|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
114703|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
114704|NCT00696878|Primary|Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles|At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.|30 minutes post dose in each treatment cycle|Participants who received corifollitropin alfa||participants|||Number
114715|NCT00696800|Secondary|Number of Cumulus-oocyte-complexes|Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who underwent IVF.||Number of cumulus-oocyte complexes||Standard Deviation|Mean
114716|NCT00696800|Secondary|Number of Follicles Categorized by Size on the Day of hCG|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|Day of HCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection and with USS data available.||Number of follicles||Standard Deviation|Mean
114705|NCT00696878|Primary|Percentage of Participants With Clinically Relevant Immunogenicity|Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.|Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle|Participants who received corifollitropin alfa and had a post dose sample for anti-corifollitropin alfa antibody testing||percentage of participants|||Number
114706|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Embryo Transfer|Biochemical pregnancy was assessed for participants who had embryo transfer by measuring serum or urinary hCG. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.||Percentage of participants|||Number
114707|NCT00696800|Secondary|Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt|Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.|Two weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.||Percentage of participants|||Number
114708|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a vital pregnancy.||Percentage of participants|||Number
114709|NCT00696800|Secondary|Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy|The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.|Up to day of miscarriage (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with a clinical pregnancy.||Percentage of participants|||Number
114710|NCT00696800|Secondary|Percentage of Gestational Sacs (Implantation Rate)|The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.|Up to 6 weeks after embryo transfer (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.||Percentage of gestational sacs||Standard Deviation|Mean
114711|NCT00696800|Secondary|Number of Embryos Transferred on Day 3|After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with embryo transfer.||Number of embryos||Standard Deviation|Mean
114712|NCT00696800|Secondary|Number of Embryos Obtained on Day 3 Categorized by Quality|Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: < 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.|Post fertilization Day 3 (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with IVF and/or ICSI, and excludes those who had embryos transferred or cryopreserved before Day 3.||Number of embryos||Standard Deviation|Mean
114713|NCT00696800|Secondary|Percentage of Fertilized Oocytes (Fertilization Rate)|The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI|Up to 18 hours after start of fertilization (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.Restricted to participants with IVF and/or ICSI.||Percentage of fertilized oocytes||Standard Deviation|Mean
114714|NCT00696800|Secondary|Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)|The number of oocytes used for ICSI was assessed, and categorized based on their quality|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. For participants who had ICSI; but also includes 3 participants whose oocytes were assessed, but ICSI was not performed.||Number of oocytes||Standard Deviation|Mean
116240|NCT00681538|Secondary|Carer Global Impressions of Change at of Treatment (Phase B).||End of treatment (Week 17)|Sample sizes were reduced as not all subjects had a Carer to make this assessment.||participants|||Number
114717|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 8|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 8 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 8.||Number of follicles||Standard Deviation|Mean
114718|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 5|Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.|On Day 5 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 5.||Number of follicles||Standard Deviation|Mean
114719|NCT00696800|Secondary|Number of Follicles Categorized by Size on Stimulation Day 1|Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.|On Day 1 of treatment (up to 1 year)|ITT population (consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to) with USS data available on Stimulation Day 1.||Number of follicles||Standard Deviation|Mean
114720|NCT00696800|Secondary|Serum Inhibin-B Levels During Stimulation|Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had Inhibin-B data available.||pg/mL||Standard Deviation|Mean
114721|NCT00696800|Secondary|Serum Progesterone (P) Levels During Stimulation|Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had P data available.||nmol/mL||Standard Deviation|Mean
114722|NCT00696800|Secondary|Serum Estradiol (E2) Levels During Stimulation|Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had E2 data available.||pmol/L||Standard Deviation|Mean
114723|NCT00696800|Secondary|Serum Luteinizing Hormone (LH) Levels During Stimulation|Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had LH data available.||IU/L||Standard Deviation|Mean
114724|NCT00696800|Secondary|Serum FSH Levels During Stimulation|Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.|Up to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa (Cori Alfa) or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants who had FSH data available.||IU/L||Standard Deviation|Mean
114725|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 8 onwards.|From Day 8 to Day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.||IU||Full Range|Median
114726|NCT00696800|Secondary|Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1|The amount of recFSH administered for a participant to reach 3 follicles >= 17 mm, starting from treatment Day 1 onwards.|From Day 1 to day of hCG treatment (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to. Restricted to participants with hCG injection.||IU||Full Range|Median
114727|NCT00696800|Primary|Mean Number of Oocytes Retrieved|Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.|Up to 36 hours after administration of hCG (up to 1 year)|ITT population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.||Number of oocytes||Standard Deviation|Mean
114728|NCT00696800|Primary|Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)|An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.|Assessed at least 10 weeks after embryo transfer (up to 1 year)|Intent to Treat (ITT) population consisting of all randomized participants who were treated with Corifollitropin Alfa or recFSH, and grouped according to the treatment they were randomized to.||Percentage of participants|||Number
114729|NCT00696787|Secondary|Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients|The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|All randomized subjects who had taken at least one dose of double-blind test article, had a baseline primary efficacy evaluation, and had at least one primary efficacy evaluation on double-blind therapy. Subjects who did not complete the study due to its discontinuation were excluded.||units on scale||Standard Error|Mean
114730|NCT00696787|Primary|Change From Baseline on the Numeric Rating Scale (NRS)|The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.|Baseline and 8 weeks|The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.||units on scale||Standard Error|Mean
114731|NCT00696774|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114732|NCT00696774|Secondary|Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks|The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114733|NCT00696774|Secondary|Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks|A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section.|Baseline, 4 Weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114734|NCT00696774|Secondary|Change From Baseline in Patient Global Impression - Improvement (PGI–I) Scale Score at 8 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114735|NCT00696774|Secondary|Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114736|NCT00696774|Secondary|Change From Baseline in the Clinical Global Impression – Severity (CGI-Severity) Scale at 8 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114737|NCT00696774|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks|The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114738|NCT00696774|Secondary|Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks|The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114739|NCT00696774|Secondary|Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks|The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
116241|NCT00681538|Secondary|Subject Global Impressions of Change at End of Treatment (Phase B).||End of Treatment (WeeK 17)|||participants|||Number
114740|NCT00696774|Secondary|Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks|The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114741|NCT00696774|Secondary|Change From Baseline HAMD-17 Maier Subscale at 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114742|NCT00696774|Secondary|Change From Baseline HAMD-17 Core Subscale at 8 Weeks|"The Core subscale (Items 1,2,3,7,8) evaluates core symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114743|NCT00696774|Secondary|Change From Baseline HAMD-17 Total Score at 8 Weeks|The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.|Baseline, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114744|NCT00696774|Secondary|Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks|"The Maier subscale (Items 1,2,7,8,9,10) represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a >=50% reduction in the Maier subscale score from baseline."|Baseline, 4 weeks, 8 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Percentage of participants||95% Confidence Interval|Number
114745|NCT00696774|Primary|Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks|"BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a >=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section."|Baseline, 4 weeks|"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group Unclassified was excluded from statistical testing."||Units on a scale||95% Confidence Interval|Least Squares Mean
114746|NCT00696761|Primary|Treatment Efficacy Was Analyzed by Validated Symptom Scores.|Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.|12 month|The population analyzed included participants receiving drug for 12 months||score||Standard Deviation|Mean
114747|NCT00696761|Secondary|Changes of International Continence Society (ICS)-Male Questionnaire, Uroflowmetry, Residual Urine Volume, and Patient's Global Impression of Improvement||3month, 6month, 12month||||||
114748|NCT00696761|Primary|Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment|"international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome~Baseline score minus 12-month score"|12months|||score||Standard Deviation|Mean
114749|NCT00696696|Secondary|Median Overall Survival (mOS)|Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment.|up to 2 years|Based on the number of patients treated.||days||95% Confidence Interval|Median
114750|NCT00696696|Secondary|Objective Response Rate|The response rate is the percentage of the patients who have a complete response or partial response based on RECIST from the start of the treatment. The response is evaluated every 2 cycles by radiologic methods (e.g., computer tomography (CT)).|up to 1 year|Based on the number of patients evaluable for response. The evaluable patients were those patients who received any treatment and had first response assessment followed by at least one confirmatory scan.||percentage of patients|||Number
114751|NCT00696696|Primary|4-month Progression Free Survival (PFS) Rate|The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles.|4 months|Based on the number of patients treated.||percentage of patients|||Number
114752|NCT00696436|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
115171|NCT00691028|Secondary|Pharmacokinetics- Serum Concentration of Infliximab|Serum level of infliximab was measured by enzyme-linked immunosorbent assay (ELISA), using a monoclonal antibody against infliximab. The lowest level of infliximab that could be reliably detected was 0.1 ug/ml.|54 weeks||||||
114753|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
114754|NCT00696436|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
114755|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114756|NCT00696436|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114757|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114758|NCT00696436|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114759|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114760|NCT00696436|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114761|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114762|NCT00696436|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114763|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114764|NCT00696436|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
114765|NCT00696436|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114766|NCT00696436|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
115119|NCT00691704|Secondary|Time to Progression|Time to progression (TTP) is defined for all patients as the time from initiation of treatment to disease progression with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006).|6 years|Subjects who experienced disease progression.||months||Full Range|Mean
114767|NCT00696423|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after booster vaccination|||subjects|||Number
114768|NCT00696423|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after booster vaccination|||subjects|||Number
114769|NCT00696423|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day follow-up period after booster vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with a documented dose.||subjects|||Number
114770|NCT00696423|Secondary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
114771|NCT00696423|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Geometric mean concentrations are given in EL.U/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
114772|NCT00696423|Secondary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
114773|NCT00696423|Secondary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
114774|NCT00696423|Secondary|Anti-PRP Antibody Concentrations|Geometric mean concentrations are given in μg/mL.|Before booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||μg/mL||95% Confidence Interval|Geometric Mean
114775|NCT00696423|Primary|The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
114776|NCT00696423|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
114777|NCT00696423|Primary|Anti-tetanus Toxoid Antibody Concentrations|Geometric mean concentrations are given in IU/mL.|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
114778|NCT00696423|Primary|Anti-diphtheria Toxoid Antibody Concentrations|Geometric mean concentrations are given in international Unit per milliliter (IU/mL).|One month after booster vaccination|Analysis was performed on the ATP cohort for immunogenicity.||IU/mL||95% Confidence Interval|Geometric Mean
114779|NCT00696423|Primary|Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations|Geometric mean concentrations are given in microgram per milliliter (μg/mL).|One month after booster vaccination|Analysis was performed on the According To Protocol (ATP) cohort for immunogenicity.||μg/mL||95% Confidence Interval|Geometric Mean
114780|NCT00696384|Secondary|Number of Participants With Adverse Events in the Double-Blind Baseline Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for SAE. A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Double-blind Baseline/Week 26 to Week 32|||participants|||Number
114781|NCT00696384|Secondary|Number of Participants With Adverse Events During the Open-Label Phase|Treatment-emergent adverse events defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after last dose of study drug, or within 30 days after the last dose of study drug for serious adverse event (SAE). A SAE is defined as any untoward medical occurrence that either results in death; is life-threatening; requires hospitalization; results in persistent or significant disability/incapacity; leads to a congenital anomaly/birth defect; or is an important medical event.|Baseline to Week 26|||participants|||Number
114782|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Systolic Blood Pressure to Week 26|The change from baseline in sitting clinic systolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.||mmHg||Standard Deviation|Mean
114783|NCT00696384|Secondary|Change From Open Label Baseline (Week 0) in Sitting Clinic Diastolic Blood Pressure to Week 26|The change from baseline in sitting clinic diastolic blood pressure measured at final visit or week 26.|Baseline and Week 26.|Safety analysis set with last observation carried forward.||mmHg||Standard Deviation|Mean
114797|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114784|NCT00696384|Secondary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Systolic Blood Pressure to Week 32|The change in sitting clinic systolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26.. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114785|NCT00696384|Primary|Change From Double-blind Baseline (Week 26) in Sitting Clinic Diastolic Blood Pressure to Week 32|The change in sitting clinic diastolic blood pressure measured at final visit or week 32 from Double-blind Baseline/Week 26. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements. Each participant's blood pressure at the Final Visit/Week 26 of the open-label phase represented their Baseline blood pressure for the double-blind reversal phase.|Double-blind Baseline (Week 26) and Week 32.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114786|NCT00696293|Primary|Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks|"The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe).~A larger reduction of the score from baseline to 12 weeks would represent a better outcome"|Baseline and 12 weeks|||units on a scale||Standard Deviation|Mean
114787|NCT00696293|Primary|Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks|"The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome~Larger reduction between MADRS from baseline to 12 weeks would represent better outcome"|baseline and 12 weeks|description of median change||units on a scale||Standard Deviation|Mean
114788|NCT00696241|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
114789|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
114790|NCT00696241|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
114791|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114792|NCT00696241|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114793|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114794|NCT00696241|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114795|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114796|NCT00696241|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114798|NCT00696241|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114799|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114800|NCT00696241|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114801|NCT00696241|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114802|NCT00696241|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
114803|NCT00696072|Secondary|Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)|All participants who received at least one dose of study drug were summarized. The participants were analyzed as per the treatment arm to which they were originally randomized.||participants|||Number
114804|NCT00696072|Secondary|Median Time to Treatment Failure (TTF) - ITT Population|Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|ITT population: All participants enrolled in the study.||Months||95% Confidence Interval|Median
114805|NCT00696072|Secondary|Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population|Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants.|At 6 months and at 12 months|ITT population=Includes all participants registered on the study. n= number at risk||percentage of participants||95% Confidence Interval|Number
114806|NCT00696072|Secondary|Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib|Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Participants who changed their treatment regimen from single-agent letrozole to letrozole + dasatinib during the study.||percentage of participants||95% Confidence Interval|Number
114807|NCT00696072|Secondary|Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population|PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014.|Day 1 to Study Completion (approximately 6 years)|ITT population includes all participants enrolled in the study. The participants were analyzed as per the treatment arm to which they were originally randomized.||months||95% Confidence Interval|Median
114808|NCT00696072|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression|CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|All treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of study drug were analyzed. The participants are analyzed as per the treatment arm to which they were originally randomized.||participants|||Number
114941|NCT00694161|Other Pre-specified|Number of Participants With Complete Heart Block|Complete heart block is the third-degree atrioventricular block in which the impulse generated in the sinoatrial node in the atrium does not propagate to the ventricles.|Baseline, Month 6, Month 12|No summary was prepared for this data as there were no reports of complete heart block.|||||
114809|NCT00696072|Primary|Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population|CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.|First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)|Evaluable Population was defined as all treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of randomized study drug. Participants presented in the treatment arm to which they were originally randomized.||participants|||Number
114810|NCT00696020|Secondary|AUC(0-3h,ss) Tiotropium [pg*h/mL]|Area under the concentration-time curve of Tiotropium at steady state (AUC(0-3h,ss)) from 0 to 3 hours post dosing after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
114811|NCT00696020|Secondary|Tmax,ss Tiotropium [h]|Time from last dosing to maximum concentration of Tiotropium in plasma at steady state (tmax,ss) after 4 weeks of treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||hours||Full Range|Median
114812|NCT00696020|Secondary|Cmax,ss Tiotropium [pg/mL]|Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss) after 4 weeks treatment.|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
114813|NCT00696020|Secondary|AUC(0-1h,ss) Olodaterol [pg*h/mL]|"Area under the concentration-time curve of Olodaterol in plasma at steady state (AUC(0-1h,ss)) from 0 to 1 hour post dosing after 4 weeks of treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
114814|NCT00696020|Secondary|Tmax,ss Olodaterol [h]|"Time from last dosing to maximum concentration of Olodaterol in plasma at steady state (tmax,ss) after 4 weeks treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients.||hours||Full Range|Median
114815|NCT00696020|Secondary|Cmax,ss Olodaterol [pg/mL]|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss) after 4 weeks of treatment.~No results displayed for Tiotropium+Olodaterol 5/2 μg because there were zero total participants analyzed for this outcome measure."|Pre-dose, 5 min, 10 min, 20 min, 40 min, 1 h, 3 h, and 6 h after the last dose.|Evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK or had insufficient data.||pg/mL||Geometric Coefficient of Variation|Geometric Mean
114816|NCT00696020|Secondary|Clinically Significant Anormalities (Laboratory Data); Marked Changes From Baseline for Vital Signs, Notable Change in ECG and New Onset of ECG Abnormalities|"Possible clinically significant anormalities (laboratory data); marked changes from baseline for vital signs, notable change in ECG and new onset of ECG abnormalities. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AEs).~All AEs with an onset after the first dose of study medication up to 21 days after the last dose of study medication were to have been assigned to the Treatment Period."|From first dose up to 21 days after last dose of study medication.|Treated Set.||participants|||Number
114817|NCT00696020|Secondary|Patient’s Global Rating|"Patient’s Global Rating at the end of the 4 week treatment period.~Patients rated their health (respiratory condition) at Day 29 (compared to the day before they commenced treatment with study medication) on a 7-point scale as “very much better (1), much better (2), a little better (3), no change (4), a little worse (5), much worse (6), or very much worse (7)”. The assessment was made prior to pulmonary function testing and all other study procedures. The Patient’s Global Rating was also completed before the Physician’s Global Evaluation.~The means are adjusted, based on an ANCOVA with terms for treatment, centre (centre random, treatment effect fixed)."|4 weeks|Full Analysis Set.||units on a patient's global rating score||Standard Error|Least Squares Mean
114818|NCT00696020|Secondary|Physician’s Global Evaluation|"Measured a 8-point scale, from 1 (poor) to 8 (excellent), as judged by the physician, over 4 weeks of treatment.~The physician made a global evaluation at the end of the Baseline Period (Test Day 1) and at each visit thereafter. These assessments were made prior to pulmonary function testing and reflected the physician’s opinion of the patient's overall clinical condition. This evaluation was based on the need for concomitant medication, number and severity of COPD exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, and other relevant clinical observations.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 week, 2 weeks and 4 weeks|Full Analysis Set.||units on a scale||Standard Error|Least Squares Mean
114819|NCT00696020|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day|The means are adjusted, Based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).|Throughout the 4 weeks treatment period|Full Analysis Set.||occasion(s)||Standard Error|Least Squares Mean
114820|NCT00696020|Secondary|Weekly Mean Evening PEF [L/Min]|"The patient will record twice daily peak flow measurements using an AM2+ device. The evening measurement will be performed at bedtime.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 weeks treatment period|Full Analysis Set.||L/min||Standard Error|Mean
114821|NCT00696020|Secondary|Weekly Mean Pre-dose Morning PEF [L/Min]|"The patient will record twice daily peak flow measurements using an Asthma Monitor®Am2+ (AM2+) device. Morning measurements will be performed immediately upon arising after the patient has cleared out mucus, prior to administration of trial and/or rescue medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|Throughout the 4 week treatment period|Full Analysis Set.||L/min||Standard Error|Least Squares Mean
115152|NCT00691093|Secondary|Study Doses|Number of subjects that changed doses throughout the study period.|Month 3 or ET|SAS||participants|||Number
114822|NCT00696020|Secondary|PEF (Unsupervised) AUC(6-12h) Response [L/Min] After First Administration and 1,2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L/min||Standard Error|Least Squares Mean
114823|NCT00696020|Secondary|FEV1 (Unsupervised) AUC(6-12h) Response [L] After First Administration and 1,2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(6-12h) response is defined as change from the baseline value. AUC(6-12h) will be calculated as the area under the curve from 6 to 12 hours on the various test days using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|6 h, 9 h and 12 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114824|NCT00696020|Secondary|FEV1 and PEF (Unsupervised) AUC(0-6h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|AUC(0-6h) for FEV1, and PEF (unsupervised) were not studied because the pertinent information from the unsupervised pulmonary function tests was for the time interval from 9 to 12 hours post-dosing.|After first administration, 1 week, 2 weeks and 4 weeks|Full Analysis Set.|||||
114825|NCT00696020|Secondary|PEF Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114826|NCT00696020|Secondary|FVC Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FVC (forced vital capacity) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114827|NCT00696020|Secondary|FEV1 Peak(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) peak(0-3h) is the maximum post-dose value during the first 3 hours after first administration and after 1, 2 and 4 weeks of treatment. Response is defined as change from the baseline value. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114828|NCT00696020|Secondary|PEF AUC(0-6h) Response [L] After 4 Weeks of Treatment|"PEF (peak expiratory flow rate L/min) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.||L||Standard Error|Least Squares Mean
114829|NCT00696020|Secondary|FVC AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FVC (forced vital capacity) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.||L||Standard Error|Least Squares Mean
114830|NCT00696020|Secondary|FEV1 AUC(0-6h) Response [L] After 4 Weeks of Treatment|"FEV1 (forced expiratory volume in 1 second) AUC(0-6h) response is defined as change from the baseline value. AUC(0-6h) will be calculated as the area under the curve from 0 to 6 hours on test day 29 using the trapezoidal rule, divided by the full duration (6 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|1 h and 10 min prior to inhalation at baseline and after 4 weeks and 30 min, 1 h, 2 h, 3 h, 4 h, 5 h and 6h after inhalation at baseline and after 4 weeks (Day 29)|Full Analysis Set.||L||Standard Error|Least Squares Mean
118854|NCT00659165|Primary|Calories Consumed During Test Meal After a 24 Hour Fast.|Total energy ingested following the 24 hour fast.|Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks|||kcal||Standard Deviation|Mean
114831|NCT00696020|Secondary|PEF AUC(0-3h) Response [L/Min] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"PEF (peak expiratory flow rate L/min) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) will be calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres/min. Baseline was defined as the mean of the 2 pre-treatment values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.||L/min||Standard Error|Least Squares Mean
114832|NCT00696020|Secondary|FVC AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment.|"FVC (forced vital capacity) AUC(0-3h) response is defined as change from the baseline value. AUC(0-3h) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114833|NCT00696020|Secondary|FEV1 AUC(0-3h) Response [L] After First Administration and After 1, 2 and 4 Weeks of Treatment|"Response is defined as change from the baseline value. AUC(0-3h) (area under the curve) was calculated as the area under the curve from 0 to 3 hours on the various test days using the trapezoidal rule, divided by the full duration (3 hours) to report in litres. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|1 h and 10 min prior to inhalation and 5 min (only for week 1 and 2), 30 min, 1 h, 2 h and 3 h after inhalation at baseline and after 1, 2 and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114834|NCT00696020|Secondary|Trough FVC Response [L] After 1, 2 and 4 Weeks of Treatment|"Trough FVC (forced vital capacity) was defined as the mean of the 2 FVC values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FVC response was defined as the change from baseline in trough FVC. Baseline FVC was defined as the mean of the 2 pre-treatment FVC values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on an ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 29."|Baseline, 1 week, 2 weeks and 4 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114835|NCT00696020|Secondary|Trough FEV1 Response [L] After 1 and 2 Weeks of Treatment.|"Trough FEV1 (forced expiratory volume in 1 second) was defined as the mean of the 2 FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, centre (centre random, all other effects fixed).~Comparisons between groups are presented for Day 15."|Baseline, 1 week and 2 weeks|Full Analysis Set.||L||Standard Error|Least Squares Mean
114836|NCT00696020|Primary|Trough FEV1 Response [L] After 4 Weeks of Treatment|"Trough FEV1 (Forced expiratory volume in 1 second) was defined as the mean of the two FEV1 values (performed at 1 h and 10 min prior to study medication inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response was defined as the change from baseline in trough FEV1. Baseline FEV1 was defined as the mean of the 2 pre-treatment FEV1 values measured at Visit 2 (-1 h and -10 min) prior to administration of the first dose of study medication.~The means are adjusted, based on ANCOVA with terms for baseline, treatment, and centre (centre random, all other effects fixed)."|Baseline and 4 weeks|Full Analysis Set (FAS). The FAS consisted of all patients who received at least 1 dose of study medication and had baseline data (pre-treatment at the end of the 2-week baseline) for at least 1 efficacy endpoint. For this trial all randomized and treated patients were included in the FAS.||L||Standard Error|Least Squares Mean
114837|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.||mmHg||Standard Deviation|Mean
114838|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.|The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks.|Full Analysis Set.||mmHg||Standard Deviation|Mean
114839|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.||mmHg||Standard Deviation|Mean
114840|NCT00695955|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.|The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.|52 weeks|Full Analysis Set.||mmHg||Standard Deviation|Mean
114841|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.||participants|||Number
114842|NCT00695955|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|56 weeks.|Full Analysis Set.||participants|||Number
114843|NCT00695903|Secondary|Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit|Investigator's assessment of clinical response. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|Test of Cure (TOC) Visit (35 to 49 days post-therapy, approximately week 8)|Subset of modified intent-to-treat population who completed TOC/Safety visit||participants|||Number
114844|NCT00695903|Primary|Number of Participants With Elevated Serum Creatinine|Number of participants with treatment-emergent serum creatinine increases ≥0.5 mg/dL (for patients with a baseline value ≤3.0 mg/dL) or ≥1.0 mg/dL (for patients with a baseline value >3.0 mg/dL) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.||participants|||Number
114845|NCT00695903|Secondary|Number of Participants With Treatment Cure at End of Therapy (EOT) Visit|Investigator's assessment of treatment cure. Treatment Cure includes successful outcomes of both clinical and microbiological assessments. Clinical cure is defined by clinical improvement of symptoms and signs associated with the underlying infection such that no further anti-infective therapy is required. Microbiological Success is defined by the eradication or presumed eradication of baseline infecting methicillin-resistant S. aureus pathogen and no superinfecting pathogen(s) (Gram-positive) or metastatic methicillin-resistant S. aureus pathogens were isolated post therapy.|End of Therapy (median day 12 and 6.5 in daptomycin and vancomycin modified intent-to treat population, respectively)|Patients who met the continuation criteria (modified intent-to-treat) and had a EOT assessment of clinical outcome.||participants|||Number
114846|NCT00695903|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations|Number of participants with treatment-emergent CPK elevations ≥5 x upper limit of normal (≥1,000 U/L) by the EOT visit.|On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)|All subjects who received at least one dose of study medication (Safety Population). Two patients in the high-dose vancomycin arm were randomized but not treated and therefore not included in the safety population.||Participants|||Number
114847|NCT00695669|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.||Subjects|||Number
114848|NCT00695669|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 51-day follow-up period (Days 0-50) after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.||Subjects|||Number
114849|NCT00695669|Secondary|Number of Subjects With Medically Attended Adverse Events (MAEs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available.||Subjects|||Number
114850|NCT00695669|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature ≥ 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.||Subjects|||Number
114851|NCT00695669|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine and for whom any post-vaccination data were available and had the symptom sheet completed.||Subjects|||Number
114852|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.|Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
114853|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
114854|NCT00695669|Secondary|Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.|At 7, 14 and 21 days after the second dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
114855|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114856|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114857|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114858|NCT00695669|Secondary|Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114859|NCT00695669|Secondary|Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.|At Days 0, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
114860|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
114861|NCT00695669|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
114862|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114863|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114864|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114865|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114866|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.|At Days 0, 7, 14, 21, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114867|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.|At Days 0, 7, 14, 21, 28, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114868|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.|At Days 0, 14, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114869|NCT00695669|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.|At Days 0, 21, 28, 35, 42 and 182.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114870|NCT00695669|Primary|Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
114871|NCT00695669|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.|At Day 0 and at Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||titers||95% Confidence Interval|Geometric Mean
114872|NCT00695669|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.|At Day 14 post Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
114873|NCT00695565|Secondary|Change in Blood Pressure From Baseline to Week 12|Systolic and Diastolic Blood Pressure were measured at clinic visits. This outcome assesses the change in blood pressure from Baseline to Week 12 of treatment.|Baseline and Week 12|ITT (Intent-to-Treat)||mmHg||Standard Deviation|Mean
115036|NCT00693303|Primary|Evaluation Tool of Children's Handwriting|This criterion-referenced tool measures a child's legibility and speed in grades one through six. The child writes letters and words, numerals, performs near point and far point copying, writes to dictation, and composes a sentence.|August 2008|||percent of legible letters||Standard Deviation|Mean
114874|NCT00695565|Secondary|Clinician Global Impression of Change (CGIC) at Week 12|At Week 12, the Investigator was asked to independently rate the subject's total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a CGIC score were analyzed.||percentage of subjects|||Number
114875|NCT00695565|Secondary|Patient Global Impression of Change (PGIC) at Week 12|At Week 12 the subject was asked to rate their total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.|Week 12|All subjects with a PGIC score were analyzed.||percentage of subjects|||Number
114876|NCT00695565|Secondary|Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score|The McGill Pain Questionnaire asks subjects to rate 15 different kinds of pain, each on a scale of 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Severe). The total score is a sum of the individual ratings and has a range from 0 to 45, where higher numbers indicate more pain. The 15 types of pain assessed are throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, and punishing-cruel. This scale was completed at the Baseline and Week 12 clinic visits. The change from Baseline is calculated as the Week 12 total score minus the Baseline total score, so greater negative numbers indicate more improvement (pain relief).|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
114877|NCT00695565|Secondary|Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Anxiety Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Anxiety, 11-14 indicates Moderate Anxiety, and 15-21 indicates Severe Anxiety. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
114878|NCT00695565|Secondary|Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)|The HADS was completed at the Baseline and Week 12 clinic visits. The Depression Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Depression, 11-14 indicates Moderate Depression, and 15-21 indicates Severe Depression. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
114879|NCT00695565|Secondary|Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)|Subjects rated overall quality of sleep over the past week using a 100 mm Visual Analog Scale (VAS) where 100=Excellent and 0=Very Poor. This scale was completed during clinic visits. Change from Baseline is a positive value where quality of sleep improved.|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
114880|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Functional Interference Scale (of 0 to 70) is a composite score that measures the degree to which pain interferes with mood, walking, work, relationships, sleep, general activity, and enjoyment of life. The composite score is a sum of the seven individual question scores. Each individual question is rated in reference to pain over the past 24 hours on a scale of 0 to 10, where 0 indicates that pain does not interfere and 10 indicates that pain completely interferes with that function, so lower scores represent better outcomes on this scale.~The change in functional interference is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
114881|NCT00695565|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation|"The Brief Pain Inventory was completed by the subject at clinic visits. The Severity Scale (of 0 to 40) is a composite score, which is the sum of the individual ratings for worst pain, least pain, average pain, and current pain. Each individual question is rated on a scale of 0 to 10, where 0 indicates No Pain and 10 indicates Pain as bad as you can imagine. The change in pain severity is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (pain relief)."|Baseline and Week 12|One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
114882|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).||percentage of subjects|||Number
114883|NCT00695565|Secondary|Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).||percentage of subjects|||Number
114884|NCT00695565|Secondary|Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale. Subjects were asked to record the worst pain in their feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (greater pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).||units on a scale||Standard Deviation|Mean
114885|NCT00695565|Secondary|Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain. A weekly average was calculated from the daily scores for each week. The change in pain is represented as the average weekly score minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)|One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation)||units on a scale||Standard Deviation|Mean
114886|NCT00695565|Primary|Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation|"Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated no pain and a score of 10 was worst possible pain.~The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief)."|Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)|One treated subject had no recorded scores and could not be included. Imputation was mLOCF (modified Last Observation Carried Forward): LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication (in which case Baseline Observation Carried Forward (BOCF) was used).||units on a scale||Standard Deviation|Mean
114887|NCT00695500|Other Pre-specified|BOLD Response to Alcohol Cue|Percent BOLD signal change during Alcohol Food Incentive Delay Task (Alcohol - Neutral)|fMRI session following 2 weeks of treatment|sample that completed the assessment||Percent Signal Change||Standard Error|Mean
114888|NCT00695500|Secondary|Alcohol Urges|"Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7.~Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol."|2.5 hr session following 3 weeks of treatment|sample that completed the assessment||Units on a scale||Standard Error|Mean
114889|NCT00695500|Primary|Alcohol Consumption|Peak Breath Alcohol Concentration during IV alcohol self-administration|2.5 hr session following 3 weeks of treatment|sample that completed the assessment||mg/%||Standard Error|Mean
114890|NCT00695435|Secondary|Tobramycin Tear Concentration Area Under the Curve (AUC)|Trapezoidal AUC was calculated from 2 to 18 minutes.|2 to 18 minutes post administration|||min*ug/mL||Standard Deviation|Mean
114891|NCT00695435|Primary|Tobramycin Tear Concentration Cmax (Maximum Concentration)|Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject’s right eye for each treatment period.|2, 4, 6, 12, and 18 minutes|||µg/mL||Standard Deviation|Mean
114892|NCT00695396|Secondary|Transfusion Dependent|Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period.|Approximately 48 weeks|The intent-to-treat (ITT) population.||participants|||Number
114893|NCT00695396|Secondary|RBC Transfusion From Day 29 Through the End of Study|incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks).|Day 29 through the end of study (approximately 48 weeks)|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.||participants|||Number
114894|NCT00695396|Primary|Red Blood Cell (RBC) Transfusion|Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)|Approximately 48 weeks|The intent-to-treat (ITT) population was defined as all participants randomly assigned to a treatment group, regardless of whether they received any treatment.||participants|||Number
114895|NCT00695318|Primary|Change From Baseline in Size of Geographic Atrophy||24 months|Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye.||mm3/year||Standard Deviation|Mean
114896|NCT00695292|Secondary|Efficacy and Safety Analysis Will be Conducted in Patients With Progressive Disease or Irreversible Toxicity on Chemotherapy Alone Who Elect to Receive Sunitinib Alone Until Progressive Disease or Irreversible Toxicity.||18 months||||||
115006|NCT00693992|Primary|PFS|PFS was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.|Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)|||months||95% Confidence Interval|Median
115037|NCT00693303|Primary|Legibility Scores on the Evaluation Tool of Children's Handwriting||June 2008 and August 2008||||||
114897|NCT00695292|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.|18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.||percentage of participants||95% Confidence Interval|Number
114898|NCT00695292|Primary|One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment||18 months|The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.||percentage of participants|||Number
114899|NCT00695188|Secondary|HAQ (Health Assessment Questionnaire)||16 weeks||||||
114900|NCT00695188|Primary|DAS-28 (Disease Activity Score in 28 Joints)|"DAS stands for Disease Activity Score and is a measure of the activity of rheumatoid arthritis. In Europe the DAS is the recognized standard in research and clinical practice.~The following parameters are included in the calculation:~Number of joints tender to the touch (TEN)~Number of swollen joints (SW)~Erythrocyte sedimentation rate (ESR)~Patient assessment of disease activity (VAS; mm)~The DAS-28 is evaluated using a scale:~0 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity > 5.1: severe disease activity"|16 weeks|||Units on a Scale||Standard Deviation|Mean
114901|NCT00695136|Primary|Change in Percentage of Time That Subjects With Autism Spend in REM Sleep.||1 month (from baseline to 1.25 mg dose)|||percentage of REM sleep||Standard Error|Mean
114902|NCT00695097|Primary|Change in Biopsy Cell Densities From Baseline to Follow-up|Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.|1 year|5 Rituximab participants and 4 Control participants provided both baseline and follow-up biopsies for analysis. 6 participants withdrew their consent.||cells/mm^3||Standard Deviation|Mean
114903|NCT00695019|Post-Hoc|Normalization of Platelets|Percentage of participants with a low platelet count at baseline who had a normal platelet count at the end of the study|48 weeks|Participants with a baseline platelet count below 150 who were evaluable for response at week 48 were included in the analysis||percentage of participants|||Number
114904|NCT00695019|Secondary|Change in Fibrotest Score|Change in fibrotest score from baseline to week 48|48 weeks|||units on a scale||Standard Deviation|Mean
114905|NCT00695019|Secondary|Change in Social Functioning|"Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48~Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities."|48 weeks|Intent-to-treat||change in score||Standard Deviation|Mean
114906|NCT00695019|Primary|Relapse Rate|"Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation~Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml."|48 weeks|Intent-to-treat||percentage of participants|||Number
114907|NCT00695019|Secondary|Change in Serum ALT|Change in Serum ALT concentration from baseline to week 48|48 weeks|Intent-to-treat||U/L||Standard Deviation|Mean
114908|NCT00695019|Secondary|Change in Serum HCV RNA Concentration|Change in serum HCV RNA concentration (log10 IU) from baseline to week 48|48 weeks|Intent-to-treat population||log10 IU||Standard Deviation|Log Mean
114909|NCT00695019|Secondary|Normalization of ALT|Percentage of participants with a normal serum ALT level at the end of the study|48 weeks|Intent-to-treat||percentage of participants|||Number
114910|NCT00695019|Secondary|Sustained Virologic Response Rate|Percentage of participants who remained HCV RNA negative throughout the study|48 weeks|Intent-to-treat||percentage of participants|||Number
114911|NCT00694603|Secondary|Progression-free Survival||From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months|||months||95% Confidence Interval|Median
114912|NCT00694603|Primary|Response Rate by CT Scan Using RECIST Criteria||8 weeks|The trial used a Simon two-stage design, which enrolled 18 pts in the first stage and was to proceed to enroll an additional 28 evaluable patients if 1 or more response was observed in the first group. This design provided a 57% chance of early termination if the true response rate was <3%. PFSand OS were calculated using the Kaplan-Meier method.||participants|||Number
114913|NCT00694564|Secondary|Safety||0, 2 weeks, 1 month, 2 month||||||
114914|NCT00694564|Primary|Wong-Baker FACES Pain Rating Scale|We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).|0, 2 weeks, 1 month, 2 months|||units on a scale||Standard Deviation|Mean
114915|NCT00694551|Secondary|Number of Participants Who Did Not Have PSA Doubling|Number of participants who did not have a PSA doubling before their last study visit, median 458 days from baseline PSA (55-613).|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.||participants|||Number
114916|NCT00694551|Secondary|Number of Participants With Prostatic Specific Antigen (PSA) Doubling|"Number of Participants Who Had a Doubling of the PSA or Proceeded to Another Therapy.~Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy."|Up to 48 months|29 patients who had serial PSA data, normalized by date and PSA.||participants|||Number
114917|NCT00694551|Primary|Occurrence of Related Adverse Events - Grade 3 or Higher|Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.|Up to 48 months|All participants who received treatment.||participants|||Number
115035|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 16|Intent to Treat Population||Percentage of participants|||Number
114918|NCT00694369|Secondary|Patient’s Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication|Patient’s Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient’s rating of the study medication for pain.|At 24 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.||Participants|||Number
114919|NCT00694369|Primary|Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.|Over the first 6 hours post the initial Day 1 dose of the study medication|Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.||Units on a Scale||Standard Error|Least Squares Mean
114920|NCT00694304|Secondary|Change From Baseline in SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
114921|NCT00694304|Secondary|Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment||Baseline and Week 52|FAS; OC||percentage of patients|||Number
114922|NCT00694304|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A||percentage of patients||Standard Deviation|Mean
114923|NCT00694304|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC; Baseline from lead-in study NCT00635219 / 11984A||percentage of patients||Standard Deviation|Mean
114924|NCT00694304|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
114925|NCT00694304|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
114926|NCT00694304|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC||units on a scale||Standard Deviation|Mean
114927|NCT00694304|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)||units on a scale||Standard Deviation|Mean
114928|NCT00694304|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS||percentage of patients|||Number
114929|NCT00694304|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|APTS||participants|||Number
114930|NCT00694161|Other Pre-specified|Change From Baseline in 6-Minute Walk Test (6MWT) at Month 3, 6 and 12|6MWT was used to assess the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.. The distance walked in 6 minutes was categorized as: Level 1: <300 meter, Level 2: 300-374.9 meter, Level 3: 375-449.9 meter, Level 4: >=450 meter.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||meters||Standard Deviation|Mean
114931|NCT00694161|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide(NT-proBNP) Levels at Week 2, 6, Month 3, 6 and 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.||picogram/mL (pg/mL)||Standard Deviation|Mean
114942|NCT00694161|Other Pre-specified|24-Hour Average Heart Rate and Maximium/Minimum Heart Rate|Holter monitor was a machine that recorded the heart rhythms. 24-hour average heart rate and maximium/minimum heart rate was recorded using Holter monitoring.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||beats per minute (bpm)||Standard Deviation|Mean
114932|NCT00694161|Other Pre-specified|Change From Baseline in Troponin I and Troponin T at Week 2, 6, Month 3, 6 and 12|Troponin I and troponin T were the cardiac markers. Troponin I and troponin T were part of the troponin complex, where troponin I was bound to actin in thin myofilaments and troponin T was bound to tropomyosin. Higher level of these markers was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
114933|NCT00694161|Other Pre-specified|Change From Baseline in the Short Form 36 (SF-36) at Month 3, 6 and 12|SF-36 was standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Scores for the 8 domains range from 0-100, where higher scores were better (100=highest level of functioning) and reported as 2 summary scores; Mental Component Score (MCS) and Physical Component Score (PCS). The score for a section was an average of the individual question scores, which were scaled 0-100, where higher scores were better.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints. Data was collected at Month 3 but not statistically summarized as planned.||Units on a scale||Standard Deviation|Mean
114934|NCT00694161|Other Pre-specified|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at Month 3, 6 and 12|KCCQ was a 23-item heart failure specific questionnaire quantified in to following 10 summary scores: physical limitation, symptom frequency, symptom severity, and symptom stability, total symptoms, quality of life, social interference, self-efficacy, overall summary and clinical summary. Total score ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life. Summary scores were scaled to range from 0 to 100, with higher scores representing greater disability.|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'n' signifies those participants who were evaluable for specific timepoints.||Units on a scale||Standard Deviation|Mean
114935|NCT00694161|Other Pre-specified|Number of Participants With Change in Patient Global Assessment (PtGA) at Month 3, 6 and 12|"Participant’s overall quality of life was measured by the PtGA. At baseline participants answered to question: in general, how do you feel today? - on a 5-point scale from '1' (excellent) to '5' (poor). At each follow-up visit, participant’s answered to question: “How do you feel today as compared to when we talked with you at your last clinic visit for this study?” on a 7-point scale- '1' markedly improved, '2' moderately improved, '3' mildly improved, '4' unchanged, '5' mildly worsened, '6' moderately worsened, '7' markedly worsened."|Baseline, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Participants|||Number
114936|NCT00694161|Other Pre-specified|Number of Participants With Increased Interstitial Markings and Pleural Effusions|Chest x-ray was done to record the presence of increased interstitial markings (a large number of interstitial markings was indicative of abnormality in the lung) and pleural effusion, which was defined as accumulation of fluid between the layers of tissue that line the lungs and chest cavity.|Baseline, Month 6, Month 12|Intent to Treat (ITT) population included all participants who received at least one dose of study medication.||Participants|||Number
114937|NCT00694161|Other Pre-specified|Cardiothoracic (CT) Ratio|Cardiothoracic ratio was defined as the transverse diameter of the heart, compared with that of the thoracic cage, used to help determine enlargement of the heart.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication.||Ratio||Standard Deviation|Mean
114938|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Week 6, Month 3, 6 and 12|NYHA: classified as ‘class I’ (participants with cardiac disease but without resulting limitations of physical activity), ‘class II’ (participants with cardiac disease resulting in slight limitation of physical activity), ‘class III’ (participants with cardiac disease resulting in marked limitation of physical activity), ‘class IV’ (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as ‘improved' (positive change), ‘no change’ or ‘worsened' (negative change).|Baseline, Week 6, Month 3, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Data at Week 6 was collected but was not summarized due to a change in the planned analysis. Here 'n' signifies those participants who were evaluable for specific timepoints.||Participants|||Number
114939|NCT00694161|Other Pre-specified|Heart Rate Variability- Percentage of Successive R-R Intervals With Greater Than 50 Msec Difference Between Normal Beats (pNN50)|Holter monitor was a machine that recorded the heart rhythms. The term ‘NN’ was used in place of ‘R-R’ when the processed beats are normal beats. The percentage of successive R-R intervals with greater than 50 msec difference between normal beats was derived by dividing NN50 by the total number of NN intervals (pNN50), where NN50 was the number of interval differences of successive NN intervals greater than 50 msec.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of intervals||Standard Deviation|Mean
114940|NCT00694161|Other Pre-specified|Heart Rate Variability (HRV)- Standard Deviation (SD) Parameters|Holter monitor was a machine that recorded the heart rhythms. HRV time-domain indices were summarized for root-mean-square of successive differences [RMS SD] of the R-R intervals (R-R is the interval between successive Rs in the ECG wave) between normal beats (NN), magid standard deviation (Magid SD) of normal to normal R-R intervals and Kleiger standard deviation of normal to normal R-R intervals (Kleiger SD). The term ‘NN’ is used in place of ‘R-R’ when the processed beats are normal beats.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||msec||Standard Deviation|Mean
115038|NCT00693238|Secondary|Disease Control||20 years after end of radiation||||||
114943|NCT00694161|Other Pre-specified|Number of Participants With Atrial Fibrillation/Flutter, Atrial Tachycardia, Non-Sustained Ventricular Tachycardia (NSVT) Beats), Sustained Ventricular Tachycardia (SVT), Sinus Pause at Month 6 and 12|Holter monitor was a machine that recorded the heart rhythms. Holter monitoring abnormalities of atrial fibrillation/flutter (rapid, irregular heart rhythm), atrial tachycardia (rapid cardiac rate), non-sustained ventricular tachycardia (NSVT)<30 beats, sustained ventricular tachycardia (SVT) >=30 beats and sinus pause (transient interruption in the sinus rhythm) were recorded.|Baseline, Month 6, Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).||Participants|||Number
114944|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Left Atrial Dimension and 4 Chamber Right Atrial Dimension at Month 6 and 12|Cardiac MRI was done to measure the left and right atrial dimensions which have diagnostic and prognostic significance in cardiology, in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.|||||
114945|NCT00694161|Other Pre-specified|Change From Baseline in 4 Chamber Interatrial Septal Thickness at Month 6 and 12|Cardiac MRI was done to measure interatrial septal thickness in the 4 chamber view.|Baseline, Month 6, Month 12|Data for this measure was not collected due to a change in the planned analysis.|||||
114946|NCT00694161|Other Pre-specified|Change From Baseline in Percentage of Left Ventricular Myocardial Mass With Amyloidosis and Left Ventricular Myocardial Mass With Fibrosis/Scar at Month 6 and 12|Cardiac MRI was done to measure percentage of LV myocardial mass with amyloidosis and LV myocardial mass with fibrosis/scar. LV myocardial mass with amyloidosis or fibrosis/scar was calculated from the product of the myocardial volume and specific gravity of heart muscle, in participants with amyloidosis or fibrosis/scar, respectively.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of LVM||Standard Deviation|Mean
114947|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Cardiac Output and Right Ventricular Cardiac Output at Month 6 and 12|Cardiac MRI was done to measure cardiac output, which was the volume of blood being pumped by the heart, in particular by the left or right ventricle in the time interval of one minute.|Baseline, Month 6, Month 12|MRI data was collected and reported for cardiac output through the measure of stroke volume as given in outcome measure 17.|||||
114948|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction and Right Ventricular Ejection Fraction at Month 6 and 12|Cardiac MRI was done to measure: left ventricular ejection fraction (LVEF) was the fraction of the EDV that is ejected out of left ventricle with each contraction and right ventricular ejection fraction (RVEF) was the fraction of the EDV that is ejected out of right ventricle with each contraction. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of EDV||Standard Deviation|Mean
114949|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricle End Diastolic Volume, Left Ventricle End Systolic Volume, Left Ventricle Stroke Volume, Right Ventricle End Diastolic Volume, Right Ventricle End Systolic Volume, Right Ventricle Stroke Volume at Month 6 and 12.|Cardiac MRI was done to measure left ventricle end diastolic volume (LVEDV), left ventricle end systolic volume (LVESV), left ventricle stroke volume (LVSV), right ventricle end diastolic volume (RVEDV), right ventricle end systolic volume (RVESV) and right ventricle stroke volume (RVSV).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||mL||Standard Deviation|Mean
114950|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass, Mass of Left Ventricular Myocardium With Amyloidosis, Mass of Left Ventricular Myocardium With Fibrosis/Scar and Right Ventricular End Diastolic Mass at Month 6 and 12|Cardiac MRI was done to measure LVM, mass of left ventricular (LV) myocardium with amyloidosis, mass of LV myocardium with fibrosis/scar and right ventricular end diastolic mass (RVEDM).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Gram||Standard Deviation|Mean
114951|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Anteroseptal, Left Ventricular Inferolateral Wall Thickness and Right Ventricular End Diastolic Free Wall Thickness at Month 6 and 12|Cardiac Magnetic Resonance Imaging (MRI) was done to measure the thickness of left ventricular anteroseptal (LVAS) wall, left ventricular inferolateral (LVIL) wall and right ventricular end diastolic free (RVEDF) wall.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||mm||Standard Deviation|Mean
114952|NCT00694161|Other Pre-specified|Number of Participants With Change From Baseline in Valvular Abnormalities at Month 6 and 12|Valvular abnormalities were those abnormalities (thickening or regurgitation) that involved one or more valves of the heart, determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
114953|NCT00694161|Other Pre-specified|Change From Baseline in Pericardial Effusion at Month 6 and 12|Pericardial effusion was the presence of an abnormal amount of fluid in the pericardial cavity, as determined by echocardiography.|Baseline, Month 6, Month 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
115039|NCT00693238|Primary|Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.||6 months after the end of radiation therapy|||Participants|||Number
114954|NCT00694161|Other Pre-specified|Change From Baseline in Tissue Doppler- Septal and Lateral Velocity at Month 6 and 12|Tissue Doppler used doppler principles to measure the annular velocities at the lateral and septal areas of the mitral annulus. s’: systolic velocity during ejection, e’: early diastolic mitral annular velocity, a’: late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific categories.||centimeter/second (cm/sec)||Standard Deviation|Mean
114955|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: Mitral Deceleration Time at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. The mitral deceleration time was the time taken from the maximum E wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||msec||Standard Deviation|Mean
114956|NCT00694161|Other Pre-specified|Change From Baseline in Doppler Data: E/A and E/e' Ratio at Month 6 and 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e’) (E/e') were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Ratio||Standard Deviation|Mean
114957|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Ejection Fraction at Month 6 and 12|Left ventricular ejection fraction (LVEF) was the fraction of the end-diastolic volume (EDV) that is ejected out of left ventricle with each contraction, estimated by echocardiography. EDV is the volume of blood within a ventricle immediately before a contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Percentage of EDV||Standard Deviation|Mean
114958|NCT00694161|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6 and 12|LVM was defined as increase in the mass of left ventricle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||Gram||Standard Deviation|Mean
114959|NCT00694161|Other Pre-specified|Change From Baseline in Echocardiographic (ECHO) Parameters at Month 6 and 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVEDD).|Baseline, Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here 'n' signifies those participants who were evaluable for specific timepoints.||millimeter (mm)||Standard Deviation|Mean
114960|NCT00694161|Other Pre-specified|Number of Participants Discontinuing From The Study Due to Clinically Significant Clinical or Laboratory Adverse Events (AEs)||Baseline up to Month 12|ITT population included all participants who received at least one dose of study medication.||Participants|||Number
114961|NCT00694161|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO:investigator assessed test to assess cardiac function.ECHO abnormality criteria:any/valvular abnormality,pericardial effusion,abnormal regional wall motion,inferior vena cava respiratory variation,posterior left ventricular wall/septal thickness>=13 millimeter(mm),right ventricular thickness>=7mm,ejection fraction <50%, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A)>=2, ratio of ‘E’to lateral/septal mitral annular velocity (e’) (E/e’prime lateral>15, E/e’prime septal>15), E deceleration time<=150 millisecond(msec),Isovolumic relaxation time<=70msec.|Baseline up to Month 12|ITT population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal(that is treatment-emergent abnormalities).||Participants|||Number
114962|NCT00694161|Other Pre-specified|Number of Participants With Greater Than or Equal to (>=) Grade 3 Treatment-Emergent AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.||Participants|||Number
114963|NCT00694161|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least one dose of study medication.||Participants|||Number
115003|NCT00693992|Secondary|Time to Deterioration in QOL and Symptom Progression Using the EORTC QLQ-C30 and LC13|The time of symptom progression will be computed for each patient. Similar to PFS and OS, the univariate analysis with log rank test will be used to evaluate the effect of the experimental arm and the multivariate analysis with Cox’s proportional hazard model will be used to evaluate the effect of the experimental arm while adjusting for other baseline prognostic factors. The rate of symptom progression at 3 and 6 months will be estimated for each arm and their difference will be tested using Fisher’s exact test.|Up to 5 years||||||
114964|NCT00694161|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least one dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
114965|NCT00694161|Primary|Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
114966|NCT00694122|Primary|Blood Glucose|Average value of repeatedly measured absolute values beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on NPH insulin as the long acting insulin; the other overnight was glargine(Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.||mmol/l||Standard Deviation|Mean
114967|NCT00694122|Secondary|Growth Hormone|Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.||ug/l||Standard Deviation|Mean
114968|NCT00694122|Secondary|Glucagon|Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.||mcg/l||Standard Deviation|Mean
114969|NCT00694122|Secondary|Cortisol|Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00.|Overnight|Participants completing both overnight visits were included in the analysis.||nmol/l||Standard Deviation|Mean
114970|NCT00694122|Secondary|Insulin Dose|NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours.|Overnight|||units||Standard Deviation|Mean
114971|NCT00694122|Primary|Blood Glucose Area Under the Curve (AUC)|Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin.|Overnight|All participants received either NPH or glargine (Lantus) on separate overnight sampling periods.||mg*10hr/dL||Standard Deviation|Mean
114972|NCT00694109|Secondary|Percent Change From Baseline in Apolipoprotein A-1|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
114973|NCT00694109|Secondary|Change From Baseline in C-Reactive Protein|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
114974|NCT00694109|Secondary|Percent Change From Baseline in Total VLDL Particles' Size and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Total VLDL Particles' Size and Chylomicron Particles' Size.||percent change||95% Confidence Interval|Mean
114975|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Small).||percent change||95% Confidence Interval|Mean
114976|NCT00694109|Secondary|Percent Change From Baseline in VLDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for VLDL Particles' Size (Medium).||percent change||95% Confidence Interval|Mean
114977|NCT00694109|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Very Low Density Lipoprotein (VLDL) Particles' Size (Large) and Chylomicron Particles' Size.||percent change||95% Confidence Interval|Mean
114978|NCT00694109|Secondary|Percent Change From Baseline in Intermediate Density Lipoprotein Particles' Size|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for Intermediate Density Lipoprotein Particles' Size.||percent change||95% Confidence Interval|Mean
114979|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Small).||percent change||95% Confidence Interval|Mean
114980|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for HDL Particles' Size (Medium).||percent change||95% Confidence Interval|Mean
114981|NCT00694109|Secondary|Percent Change From Baseline in HDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).||percent change||95% Confidence Interval|Mean
114982|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Very Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Very Small).||percent change||95% Confidence Interval|Mean
114983|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Small)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Small).||percent change||95% Confidence Interval|Mean
114984|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Medium)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Medium).||percent change||95% Confidence Interval|Mean
114985|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Large)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Large).||percent change||95% Confidence Interval|Mean
114986|NCT00694109|Secondary|Percent Change From Baseline in LDL Particles' Size (Total)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to End of treatment; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time. Number of participants analyzed = participants with available data for LDL Particles' Size (Total).||percent change||95% Confidence Interval|Mean
114987|NCT00694109|Secondary|Percent Change From Baseline in Lipoprotein (a)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
114988|NCT00694109|Secondary|Percent Change From Baseline in Triglycerides|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
114989|NCT00694109|Primary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
115004|NCT00693992|Secondary|Response Rate (RR)|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions."|Duration of treatment (up to 5 years)|||percentage of participants|||Number
114990|NCT00694109|Primary|Percent Change From Baseline in Total Cholesterol|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
114991|NCT00694109|Primary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
114992|NCT00694109|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered >=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered <6 months from their last dose of mipomersen in their index study).|Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)|Analysis was performed on Safety set. Here n=participants with lipid parameter assessment at specified time.||percent change||95% Confidence Interval|Mean
114993|NCT00694096|Secondary|Overall Survival|The length of time from the start of treatment for a disease that patients are still alive; no time limit was imposed on data collection|2399 days|All patients that received study treatment and PET scans at baseline and follow-up||days||Full Range|Median
114994|NCT00694096|Primary|Proliferative Response|Number of patients achieving proliferative response (at least Partial Response) assessed with follow-up FLT-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average SUVmax relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.||participants|||Number
114995|NCT00694096|Primary|Metabolic Response|Number of patients achieving metabolic response (at least Partial Response) assessed with follow-up FDG-PET scans compared to baseline using the European Organization for Research and Treatment of Cancer (EORTC) response criteria based on the change in the follow-up average maximum standardized uptake value (SUVmax) relative to baseline as follows: Partial Response (PR) ≥ 25% decrease in SUVmax; Progressive Disease (PD) ≥ 25% increase in SUVmax; Stable Disease (SD) < 25% change in SUVmax.|4 weeks|Nineteen patients were included in the analysis. One patient was found to have pathologically proven sarcoidosis at the location of the PET imaging and was therefore removed from analysis.||participants|||Number
114996|NCT00694070|Primary|Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)|Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.|1-2 hours|||participants|||Number
114997|NCT00694070|Primary|Number of Participants Rated as <= 3 (Success in Using the Program)|"Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:~successful~successful after being referred to user instructions~success with assistance (similar to a customer call)~unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3."|1-2 hours|||Participants|||Number
114998|NCT00694070|Primary|Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)|"After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.~Very Simple~Simple~Neither simple nor difficult~Difficult~Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3."|1-2 hours|per protocol||Participants|||Number
114999|NCT00694018|Primary|The Roland Morris Disability Questionnaire (RDQ) Score|The Roland Morris Disability Questionnaire score ranges from 0 to 24, with higher scores indicating greater disability|12 months|The number of participants analyzed is slightly lower than the number who completed the study at 12 months due to item non-response on the final study survey||units on a scale||Standard Deviation|Mean
115000|NCT00693992|Secondary|Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.|Duration of study (up to 5 years)|189 participants were evaluable for adverse events.||percentage of participants|||Number
115001|NCT00693992|Secondary|VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS||Up to 6 weeks||||||
115002|NCT00693992|Secondary|Time to Quality of Life or Symptom Deterioration as Assessed by Continuous Quality of Life (QOL) Scores, Including QLQ-C30 and LC13 Subscales|The time of symptom progression will be computed for each patient. Similar to PFS and OS, the univariate analysis with log rank test will be used to evaluate the effect of the experimental arm and the multivariate analysis with Cox’s proportional hazard model will be used to evaluate the effect of the experimental arm while adjusting for other baseline prognostic factors. The rate of symptom progression at 3 and 6 months will be estimated for each arm and their difference will be tested using Fisher’s exact test.|Up to 5 years||||||
115007|NCT00693784|Secondary|Roland-Morris Disability Questionnaire|24-item questionnaire with score determined by the number of items checked by the subject. Items assess the effect of back pain on limitations of normal daily activities. Best value = 0 (least disability). Worst value = 24 (most disability). Higher number indicate greater disability.|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks||Units on a scale||Standard Deviation|Mean
115008|NCT00693784|Secondary|Visual Analog Scale for Low-back Pain|"100 mm line anchored on the left with the descriptor No pain (best value = 0 mm) and anchored on the right with the descriptor Worst possible pain (worst value = 100 mm). Lower scores indicate less pain."|Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks|n=15 (all participants at baseline and 26-week primary endpoint) n=13 at 52 weeks n=11 at 104 weeks||mm||Standard Deviation|Mean
115009|NCT00693784|Primary|Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)|The primary outcome for this safety study includes the number and types of adverse events reported in the study. The data fields in this section do not allow for reporting all aspects of this outcome (i.e., the number of adverse events, as well as the types of event). These numbers were entered and are reported in the adverse event section of the Results.|104 weeks|All 15 participants available through 26-week primary endpoint. One voluntary withdrawal and 1 lost-to-follow-up between 26-week follow-up and 52-week extended follow-up. One additional voluntary withdrawal and 1 additional lost-to-follow-up between 52-week extended follow-up and 104-week extended follow-up.||Events|||Number
115010|NCT00693719|Secondary|Overall Survival|Still alive for a certain period of time after they were diagnosed with or started treatment|Measured from the start of protocol therapy until the date of death from any cause or will be censored at the date the patient was last known to be alive, assesed up to 13 months|||Days||95% Confidence Interval|Median
115011|NCT00693719|Primary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months|||Days||Standard Error|Median
115012|NCT00693706|Primary|Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.|GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold rise||95% Confidence Interval|Geometric Mean
115013|NCT00693706|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
115014|NCT00693706|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
115015|NCT00693706|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
115016|NCT00693706|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
115017|NCT00693706|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 90-day (Days 0-89) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
115018|NCT00693706|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
115083|NCT00692341|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||hr||Full Range|Median
115019|NCT00693706|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs).|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-182)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
115020|NCT00693706|Primary|Number of Subjects With Solicited General Symptoms.|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).||subjects|||Number
115021|NCT00693706|Primary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the documented dose. The analysis of solicited symptoms based on the Total Vaccinated cohort included only vaccinated subjects and doses with documented safety data (i.e., symptom screen /sheet completed).||subjects|||Number
115022|NCT00693498|Secondary|wrCRP Levels||days||||||
115023|NCT00693498|Primary|12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio|plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.|12 hours post-cardiopulmonary bypass|Only data from those subjects receiving transfusions was analyzed as the study intervention was the type of red blood cell and platelet transfusion (washed v. unwashed).||ratio||Standard Error|Median
115024|NCT00693485|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment||Number of Letters Read Correctly||Standard Deviation|Mean
115025|NCT00693485|Primary|Percentage of Patients With a Visual Field Improvement in the Study Eye|Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.|Baseline, Month 6|Safety Population: all patients who received 1 dose of study medication or sham treatment||Percentage of Patients|||Number
115026|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)|"Overall, how satisfied are you with your eyelashes? Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied)"|Baseline to Week 20|Intent to Treat Population||score on a scale||Standard Deviation|Mean
115027|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 20|Intent to Treat Population||intensity unit||Standard Deviation|Mean
115028|NCT00693420|Secondary|Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)|Baseline to Week 16|Intent to Treat Population||intensity unit||Standard Deviation|Mean
115029|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 20|Intent to Treat Population||percentage of AOI (in pixels)||Standard Deviation|Mean
115030|NCT00693420|Primary|Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)|The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])|Baseline to Week 20|Intent to Treat Population||Percentage of participants|||Number
115031|NCT00693420|Other Pre-specified|Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16|"Overall, how satisfied are you with your eyelashes?~Possible Answers on a 5 point scale as follows:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied"|Baseline to Week 16|Intent to Treat Population||score on a scale||Standard Deviation|Mean
115032|NCT00693420|Secondary|Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.|Baseline to Week 16|Intent to Treat Population||percentage of AOI (in pixels)||Standard Deviation|Mean
115033|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)|Upper eyelash length technologically measured in millimeters|Baseline to Week 20|Intent to Treat Population||millimeters||Standard Deviation|Mean
115034|NCT00693420|Secondary|Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16|Upper eyelash length technologically measured in millimeters|Baseline to Week 16|Intent to Treat Population||millimeters||Standard Deviation|Mean
117158|NCT00672555|Secondary|Cosmetic Score|Patients was sent a postal questionnaire at 1 year, assessing cosmesis with the body image questionnaire adapted from Dunker et al. Cosmetic score resulting form 3 questions: worst 3; best 24.|1 year|||Units on a scale||Standard Deviation|Mean
115040|NCT00693225|Secondary|Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|16 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade D. 14 of the 43 participants in the Omeprazole/sodium bicarbonate PM dose arm were LA Grade D.||percentage of participants|||Number
115041|NCT00693225|Secondary|Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|25 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C. 29 of the 43 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C.||percentage of participants|||Number
115042|NCT00693225|Primary|Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment|"After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:~LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up."|8 weeks|||percentage of patients|||Number
115043|NCT00693160|Secondary|Cerebrospinal Fluid (CSF) Prostaglandin E2 (PGE2) Concentration|Concentration of prostaglandin E2 (PGE2) in Cerebrospinal fluid (CSF) 2.5 hours post injection of intrathecal ketorolac|2.5 hours|11 Subjects in the Intrathecal Ketorolac group received post study treatment analysis of CSF for PGE2. We were not able to obtain CSF samples in 3 of the subjects post study drug injection.||picograms per milliliter||Standard Deviation|Mean
115044|NCT00693160|Primary|Hyperalgesia|Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament|24 hours|||centimeters^2||Standard Deviation|Mean
115045|NCT00693017|Secondary|Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures|Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks||||||
115046|NCT00693017|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)||||||
115047|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase|BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
115048|NCT00692913|Secondary|Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 52|Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
115049|NCT00692913|Secondary|Falls Per Participant|"Number of falls per participant was measured.~The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.~In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the~SPONSOR and served as a guideline to standardize operational procedures for fall adjudication."|Up to Week 52|Intent-to-Treat (ITT) population included all randomized participants within the treatment group to which they were randomized regardless of whether or not a participant may have dropped out in the base or continued into the extension study.||Number of Falls||Standard Deviation|Mean
115050|NCT00692913|Secondary|Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density|Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy.|Baseline and Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.||Percent Change||95% Confidence Interval|Least Squares Mean
115051|NCT00692913|Secondary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52|"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 52|The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period.||Percentage of Participants|||Number
115052|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase|Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
115053|NCT00692913|Secondary|Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio|N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.|Baseline and Week 26|Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
115054|NCT00692913|Primary|Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26|"Percentage of participants with serum levels of 25-hydroxyvitamin D below~20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls."|Week 26|"Full Analysis Set Population (FAS) included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were~assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period."||Percentage of Participants|||Number
115055|NCT00692770|Other Pre-specified|Biomarker Analysis||From randomization up to 4 years or until disease recurrence whichever came first||11/2016||||
115056|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- General (G) Total Score|The PWB, FWB, SWB and EWB were summed to form the FACT-G total score. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). FACT-G scores ranged from 0 to 108 and the higher scores represented a better quality of life. The MID for the FACT-G total score was in the range of 6 to 7. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-G score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
115057|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score|The FACT-HEP is a 45 item, self-administered, multi-dimensional, psychometrically sound questionnaire used extensively in oncology clinical trials. FACT-HEP consisted of five subscales: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The PWB, FWB, SWB and EWB were summed to form the FACTGeneral (FACT-G) total score. The FACT-G and HCS scores were summed to form the FACT-HEP total score. FACT-HEP scores ranged from 0 to 180 and the higher scores represented a better quality of life. Subjects responded to each item on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). The minimally important difference (MID) for the FACT-Hep total score was in the range of 8 to 9. The results on the ANCOVA analysis of time-adjusted AUC for the FACT-HEP score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
115058|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D VAS is a measure that represents health status as a single value. It is a 20-centimetre vertical graduated visual analogue scale with scores that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). The respondent rated his/her current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the EQ-5D VAS. A 3-digit number (including leading zeros) was read off the scale from the point where the respondent’s line crossed the scale, which was the EQ-5D VAS score. A change of at least 7 points on the VAS was considered as minimally important. The results on the ANCOVA analysis of time-adjusted AUC for the EQ-5D VAS score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
115059|NCT00692770|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D is a generic quality of life preference based on a validated instrument used in cancer and in general population, with 2 parts: Index and Visual Analogue Scale. The EQ-5D Index is a descriptive system of the following health dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Subjects were asked to choose any one of the 3 response levels for each dimension: no problems, some problems, and severe problems. The 5 health dimensions were summarized into a single score, the EQ-5D Index score which ranged from -0.59 to 1 with higher scores representing better health states (0=death, 1= perfect health, and -0.59=a health state worse than death). A change of at least 0.10 to 0.12 points was considered a minimally important difference using Eastern Cooperative Oncology Group Performance Status as the anchor. The results on the Analysis of covariance of timeadjusted Area under curve for the EQ-5D index score were reported.|Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit|FAS included participants who were randomized to study treatments.||Unit on a scale||95% Confidence Interval|Least Squares Mean
115060|NCT00692770|Secondary|Overall Survival (OS)|"OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. NA in the reported data indicates values could not be estimated due to censored data."|From randomization of the first subject until 4 years later.|FAS included participants who were randomized to study treatments.||Days||95% Confidence Interval|Median
115061|NCT00692770|Secondary|Time to Recurrence (TTR) by Independent Assessment|"TTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. NA in the reported data indicates values could not be estimated due to censored data."|From randomization up to 4 years or until disease recurrence whichever came first|FAS included participants who were randomized to study treatments.||Days||95% Confidence Interval|Median
115062|NCT00692770|Primary|Recurrence Free Survival (RFS) by Independent Assessment|"Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans.~RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death."|From randomization up to 4 years or until disease recurrence whichever came first|Full analysis set (FAS) included participants who were randomized to study treatments.||Days||95% Confidence Interval|Median
115063|NCT00692692|Primary|Post-surgical Infeciton|Occurence of infection after surgery|four weekis|36 consented and agreed to participate in study; all 36 were used for analysis for incidence of infeciton||participants|||Number
115064|NCT00692692|Primary|Patient Satisfaction With the Procedure||one year from time of operation||||||
115065|NCT00692419|Primary|Change in Pain, Sexual Dysfunction, and Depression Symptoms|The primary outcome of this study is the change in symptom scores during the intervention phase of the study|12 months|change in pain score during intervention period. In adjusted models, we used mixed effects linear regression to compare changes in symptom scores between the two study arms over the duration of the intervention, and to compare symptom scores among individual patients across the observation and intervention phases.||units on a scale||Standard Error|Mean
115066|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in Cun following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Median
115067|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Cuneus (Cun) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in Cun following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
115068|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in AnG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
115069|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Angular Gyrus (AnG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal using functional Magnetic Resonance Imaging Signal between RVIP task and control task in AnG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
115070|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
115071|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Middle Frontal Gyri (MFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in MFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
115072|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Abstinent Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following not smoking for 24 hours. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
115073|NCT00692406|Primary|Percent Signal Change in fMRI BOLD Signal Between RVIP Task and Control Task in Inferior Frontal Gyri (IFG) During Sustained Attention Task on Satiated Day|Percent signal change in BOLD (Blood Oxygenation Levels Dependent) signal between RVIP task and control task using functional Magnetic Resonance Imaging Signal in IFG following smoking as usual. Differences in brain activations were considered significant at p<.001.|12.5 minutes of fMRI scanning following smoking as usual|the reason the number of baseline participants does not match those analyzed is because of drop outs, screen fails, and excessive head motion during scanning.||percentage of signal change||Standard Deviation|Mean
115074|NCT00692341|Secondary|Unbound Maximum Observed Plasma Concentration (Cmaxu)|Cmaxu is the highest measured unbound plasma concentration during the dosing interval.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK concentration population included all participants who were treated and had at least 1 concentration measurement. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
115075|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClastu) for unbound drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
115076|NCT00692341|Secondary|Unbound Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)u]|AUC (0 - ∞)u = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) for unbound drug. It is obtained from AUCu (0 - t) plus AUCu (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
115077|NCT00692341|Secondary|Unbound Apparent Volume of Distribution (Vzu/F)|Volume of distribution of unbound drug is defined as the theoretical volume in which the total amount of unbound drug would need to be uniformly distributed to produce the desired plasma concentration of unbound drug. Unbound apparent volume of distribution after oral dose (Vzu/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||L||Geometric Coefficient of Variation|Geometric Mean
115078|NCT00692341|Secondary|Unbound Apparent Oral Clearance (CLu/F)|Clearance of an unbound drug is a measure of the rate at which an unbound drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Unbound drug clearance is a quantitative measure of the rate at which an unbound drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||mL/min||Geometric Coefficient of Variation|Geometric Mean
115079|NCT00692341|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.||Ratio||Geometric Coefficient of Variation|Geometric Mean
115080|NCT00692341|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the oral bioavailability.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
115081|NCT00692341|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||mL/min||Geometric Coefficient of Variation|Geometric Mean
115082|NCT00692341|Secondary|Plasma Elimination Half-life (t1/2)|Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||hr||Standard Deviation|Mean
115084|NCT00692341|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
115085|NCT00692341|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hrs post-dose|PK parameter analysis population included all participants who were treated and had at least 1 of the PK parameters of interest.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
115086|NCT00692341|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 12, 16, 24, 36, 48, 96 and 144 hours (hrs) post-dose|Pharmacokinetic (PK) concentration population included all participants who were treated and had at least 1 concentration measurement.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
115087|NCT00692237|Secondary|Ejection Fraction (EF) Defined as the Volume of Blood Ejected With Each Beat Was Measured on Cine-Cardiac Magnetic Resonance (CMR) Images Before and After Three Months Treatment With Sildenafil and Placebo (100 mg/Day).|The volume of blood within a ventricle immediately before a contraction is known as the end-diastolic volume; the volume of blood left in a ventricle at the end of contraction is end-systolic volume. The difference between end-diastolic volume and end-systolic volumes is the volume of blood ejected with each beat. Ejection fraction (Ef) is the fraction of the end-diastolic volume that is ejected with each beat; expressed as percentage of EDV. This is a measure of cardiac performance that can be deteriorated in diabetic cardiomyopathy.|0 and + 3 months|"We included in this analysis all the patients that concluded the study (Sildenafil group = 29; Placebo group = 25).~The 4 randomized patients who discontinued, did not perform the second after-treatment CMR evaluation.~Analysis was per protocol."||Percentage % of volume (delta)||Standard Deviation|Mean
115088|NCT00692237|Primary|Left Ventricular Torsion Defined as Change in Ventricular Mid-wall Rotation (°) Measured by Cine-Cardiac Magnetic Resonance (CMR) Imaging With Tagging, Before and After Three Months of Treatment With Sildenafil and Placebo (100 mg/Day).|Diabetic cardiomyopathy and hypertrophy are characterized by an increase in cardiac torsion Normal value of rotation are < 12°; in hypertrophic heart such values can raise up to 20-25°. A reduction in left ventricular wall rotation is a sign of improvement after removal of known causes of hypertrophy (for example after surgical repair of aortic stenosis). Based on previous studies a reduction of 3 degrees (°) is considered clinically significant.|0 and + 3 months|An overall sample size of 32 subjects (16 for each group) would thus have given a 90% power to detect the specified minimum detectable difference (3°) at a 2-sided significance level of 0.01; 59 patients were enrolled: 29 randomized to Sildenafil and 25 randomized to Placebo completed the trial. Analysis was per primary efficacy outcome (LV-q).||Degree angle (delta)||Standard Deviation|Mean
115089|NCT00692211|Primary|Colorectal Cancer Screening|Completing fecal blood test within 90 days of enrolling|3 months|||participants|||Number
115090|NCT00692185|Secondary|Anxiety||Measured at Week 8||||||
115091|NCT00692185|Primary|Weight Gain||Measured at Week 8|||lbs||Standard Deviation|Mean
115092|NCT00692003|Primary|Number of Participants Considered Responders as Assessed During the Maintenance Period|The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease from baseline in Primary Generalised Tonic-Clonic Seizures (PGTCS) frequency of >= 50% (i.e. 28-day PGTC seizure frequency in the period from Week 4 to the Week 16 visit compared to Week -8/-4 to randomization at Week 0). Each participant's response to treatment was assessed on the basis of their seizure diaries. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) through out the titration and maintenance treatment periods until the Early termination Visit at Week 16. Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16)||||||
115093|NCT00692003|Secondary|Absolute Change From Baseline in 28-day PGTC Seizure Frequency|Absolute Change from Baseline in 28-day PGTC Seizure Frequency was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.|Baseline and up to 16 weeks|138 subjects at 40 to 60 centres were planned to enter the maintenance period (77 subjects per arm). However, this study was terminated early at the Sponsor’s discretion. When the decision was made to terminate the study, only 6 subjects had been enrolled. Therefore, no analysis has been performed.|||||
115094|NCT00691938|Secondary|Rate of Hematologic Improvement.|"-Hematologic improvement (HI). Includes the following categories:~Erythroid response: Hemoglobin increase by ≥ 1.5 g/dL over baseline in which the pretreatment hemoglobin is < 11 g/dL or reduction of RBC transfusions of at least 4 RBC transfusions / 8 wk compared with the pretreatment transfusion number in the previous 8 weeks.~Platelet response. Absolute increase of > 30 x 10^9/L for patients starting with 20 x 10^9/L or increase from < 20 x 10^9/L to > 20 x 109/L and by at least 100%~Neutrophil response. At least 100% increase and an absolute increase > 0.5 x 109/L for patients with pretreatment neutrophils < 1.0 x 109/L)"|Up to 12 months|||percentage of participants|||Number
115095|NCT00691938|Secondary|Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)|Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL).|Up to 12 months|||percentage of participants|||Number
115096|NCT00691938|Secondary|Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|Completion of follow-up (median follow-up was 58 months)|||months||Full Range|Median
115097|NCT00691938|Secondary|Event-free Survival|Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)|||days||95% Confidence Interval|Median
115098|NCT00691938|Secondary|Progression-free Survival||Completion of follow-up (median follow-up was 58 months)|Data was not collected for this outcome measure. Progression is very hard to define for MDS and AML and including it as a pre-specified secondary outcome measure in the protocol was an oversight.|||||
115099|NCT00691938|Secondary|Remission Duration|Defined as the first date that all criteria for CR, CRi or HI are fulfilled to the date of treatment failure, relapse from CR, or death due to any cause.|Completion of follow-up (median follow-up was 58 months)|Number of participants analyzed include those participants who met the criteria for CR, CRi, or HI.||days||Full Range|Median
115100|NCT00691938|Secondary|Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced|Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.|Up to 13 months after start of treatment|||percentage of participants|||Number
115101|NCT00691938|Secondary|Time to Response|Time to response is defined as the date of the first dose of study drug to the date that all criteria for CR or CRi are fulfilled.|Up to 12 months|Number of participants analyzed are participants that met the criteria for CR or CRi.||days||Full Range|Median
115102|NCT00691938|Secondary|Changes in Quality of Life Scores as Measured by the Function Assessment of Cancer Therapy-Leukemia (FACT-Leu) Version 4|-The FACT-Leu consists of a 27-item compilation of general questions divided into four primary quality of life domains: physical well-being, social/family well being, emotional well-being, and functional well-being along with a 17 item subscale developed specifically for patients with leukemia.|Up to approximately 12 months after start of treatment|Data was not collected for this outcome measure.|||||
115103|NCT00691938|Secondary|Rate of Cytogenetic Complete Remission (CRc)|Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.|Up to 12 months|||percentage of participants|||Number
115104|NCT00691938|Primary|Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)|"Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL.~Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.~Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL)."|Up to 12 months|||percentage of participants|||Number
115105|NCT00691938|Primary|Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine||Completion of Phase I enrollment for MTD (approximately 26 months)|After enrolling all Phase I patients in Dose Levels 1-5b, the maximum tolerated dose was not determined. The Phase II portion of the study used the 5b dose level.||mg (level 5b dosing schedule)|||Number
115106|NCT00691808|Primary|Treatment Compliance|Subjects were considered compliant if they had taken >70% of possible doses of the study drug.|End of study|||Percentage of Participants||Standard Deviation|Mean
115107|NCT00691808|Primary|Number of Subjects Reporting Adverse Events Leading to Withdrawal||28 days|||Participants|||Number
115108|NCT00691808|Primary|Number of Subjects Reporting at Least One Adverse Event (AE)|An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.|28 days|||Participants|||Number
115109|NCT00691808|Secondary|Change From Baseline in Epworth Sleepiness Scale at Day 28|The Epworth Sleepiness Scale is a self-administered questionnaire used to help quantify a subject's level of daytime sleepiness. Subjects recorded their chances of dozing on a scale of 0 to 3, with 0 being no chance and 3 being a high chance. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28|||Units on a scale||Standard Deviation|Mean
115110|NCT00691808|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index at Day 28|The Pittsburgh Sleep Quality Index is a self-rated questionnaire that assesses sleep quality and disturbances. Responses were scored on a scale of 0 to 3 where 3 is the negative extreme. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28|||Units on a scale||Standard Deviation|Mean
115111|NCT00691808|Secondary|Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28|The subjects were asked to describe their memory ability in a variety of situations of everyday life (a list of 25 questions) using a 5-point scale, with a lower score being a negative assessment. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.|Day 28|||Units on a scale||Standard Deviation|Mean
115112|NCT00691808|Secondary|Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28|Subjects are asked to recall words from the preceding week's 15-Words Test. Baseline (Day -1) scores (scale 0-15, 0 being the worst) were subtracted from Day 28 scores to obtain the score change from baseline.|Day 28|||Number of words||Standard Deviation|Mean
115113|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||14 to18 days|||Participants|||Number
115114|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||25 to 27 days|||Participants|||Number
115115|NCT00691808|Secondary|Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28|The 15-Words Test is used to measure verbal learning and memory. Subjects are scored on the number of recognized words on a scale of 0-15, with 0 being the worst and 15 being the best. The baseline (Day -1) score was subtracted from the Day 28 score to obtain the Score Change from Baseline.|Day 28|||Number of words||Standard Deviation|Mean
115116|NCT00691808|Primary|Number of Participants Who Were Exposed to LX6171||≥28 days|||Participants|||Number
115117|NCT00691808|Secondary|Plasma Concentration||Day 28|||ng/mL||Standard Deviation|Mean
115118|NCT00691704|Secondary|Duration of Response|The duration of response, defined only among the responders, is measured from start of achieving Partial Response (PR) [first observation of PR before confirmation] to the time of disease progression, with deaths owing to causes other than progression not counted as events, but censored (Durie et al., 2006). Duration of response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years|||months||Full Range|Mean
115120|NCT00691704|Secondary|Overall Survival|Overall survival is defined as the time from the date of initiation of treatment to the date of death due to any cause. Overall response rate will be estimated with its 80% confidence interval, and the numbers of subjects achieving a sustained complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) will be tabulated. Overall survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 years|Subjects who initiated drug therapy. Eleven patients are still alive as of 2/28/14.||months||Full Range|Mean
115121|NCT00691704|Secondary|Time to Response|Time to response will be measured in the population of subjects with a confirmed response as the time from the date of initiation of treatment to the date of the first documentation of a confirmed response. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). Time to response will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|6 months|Subjects who responded to drug induction therapy.||months||Full Range|Mean
115122|NCT00691704|Primary|Progression Free Survival|Progression free survival (PFS) is defined for all subjects as the time from the date of initiation of treatment to the date of first documentation of relapse, progression, or death due to any cause. Full restaging was performed at 6, 12, 18, 24, 36, 48, 60, 72 months). PFS survival will be estimated and plotted with the Kaplan-Meier method. The median will be calculated with 95% confidence intervals.|2 years|Subjects enrolled and able to initiate induction therapy.||participants|||Number
115123|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.|14 Days minus baseline|||Percent change||Standard Deviation|Mean
115124|NCT00691665|Primary|Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline|||Percent change||Standard Deviation|Mean
115125|NCT00691665|Primary|Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|||Percent change||Standard Deviation|Mean
115126|NCT00691665|Primary|Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|14 Days minus baseline|||Percent change||Standard Deviation|Mean
115127|NCT00691652|Secondary|Identity of the Gene Activated by Clofarabine Therapy by Using Genomic DNA and RNA Array Technology||Twice monthly at standard of care visits for 3 months post last cycle of chemotherapy.||||||
115128|NCT00691652|Secondary|Whether Response to Clofarabine Alone or in Combination With Rituximab Correlates With Changes in Global Serum DNA Methylation Index||Duration of the study, up to 1 year.||||||
115129|NCT00691652|Secondary|Whether Clofarabine Acts as an Inhibitor of DNA Methylation Similar to Cladribine by Performing Scientific Correlates||Duration of the study, up to 1 year.||||||
115130|NCT00691652|Secondary|Determine the Safety and Efficacy of Clofarabine in Combination With Rituximab||Duration of the study, up to 1 year.||||||
115131|NCT00691652|Secondary|Determine One-year Progression Free Survival Using the MTD of Clofarabine With Rituximab in Relapsed CD20+NHL||One year after study drug(s) have been given. Duration of study up to 1 year.||||||
115132|NCT00691652|Primary|Estimate Objective Response Rates of Oral Clofarabine in Combination With Rituximab in Relapsed CD20+NHL||Oral Clofarabine x 14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle||||||
115133|NCT00691652|Primary|The Maximum Tolerated Dose (MTD) of Oral Clofarabine in Adult Patients With Relapsed CD20+ Non-Hodgkin Lymphoma(NHL)|"Initially, 3 patients will be enrolled into a dose level during the dose-escalation portion:~If no patient experiences dose-limiting toxicities during the first 4 weeks, then 3 patients will be enrolled into the next dose level.~If one of the three patients develops dose-limiting toxicities, then 3 additional patients will be enrolled in that cohort. If none of the additional 3 patients experiences dose-limiting toxicities, then further dose-escalation occurs.~If one additional patient experiences dose-limiting toxicities, then the maximum tolerated dose is exceeded."|14 days for up to 8 cycles (1 cycle equals 14 days on drug, 14 days off drug) for a total of up to 224 days|||Number of participants|||Number
115153|NCT00691093|Secondary|Time To Onset Of Treatment Response|Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.|Month 1, Month 2, Month 3 or ET|FAS||weeks||Full Range|Median
115214|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Morning|Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Full Range|Mean
115134|NCT00691483|Other Pre-specified|Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12|Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline through Week 5|Number of participants analyzed = participants with FQA through Week 5, excluding 157 participants for whom FTND was not done at the time of FQA (1 participant also had inconsistent FQA date with first dosing date). Analysis done by smoking status at Week 12 (Responder for the primary endpoint of CA Weeks 9-12).||Units on a scale||Standard Deviation|Mean
115135|NCT00691483|Secondary|Percentage of Participants With 4-week Point Prevalence of Nonsmoking|Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.|Week 24|"FAS. Missing inventory interview questions of whether the subject had smoked or used any other tobacco products in the last 4 weeks were not imputed. Missing CO was imputed as =<10 ppm."||Percentage of participants|||Number
115136|NCT00691483|Secondary|Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)|Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.|Week 12 and Week 24|"FAS. Missing weekly interview questions of whether the subject had smoked in the last 7 days were not imputed; missing CO was imputed as =<10 ppm."||Percentage of participants|||Number
115137|NCT00691483|Secondary|Percentage of Participants With Long Term Quit Through Week 24|Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.|Week 9 through Week 24|FAS. If the number of days smoked was missing for a subject visit, the CA responder status of the subject at that visit determined the imputation.||Percentage of participants|||Number
115138|NCT00691483|Secondary|Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24|Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products ‘since the last visit’ and did not have CO >10 ppm.|Week 9 through Week 24|FAS. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.||Percentage of participants|||Number
115139|NCT00691483|Primary|Percentage of Participants With 4-week Continuous Abstinence (CA)|The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products ‘since the last visit’ and did not have CO >10 ppm.|Week 9 through Week 12|Full analysis set (FAS): took at least 1 dose, including partial doses, of randomized study drug. Missing CO measurements imputed as =<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions.||Percentage of participants|||Number
115140|NCT00691327|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|5 years|All patients who had a breast implant satisfaction rating||Units on a scale||Standard Deviation|Mean
115141|NCT00691327|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|5 years|All enrolled patients||Percentage by Patient||95% Confidence Interval|Number
115142|NCT00691210|Primary|The Maximum Tolerated Dose of Niacinamide in the Combination of Vorinostat and Niacinamide||3 years|||mg/kg|||Number
115143|NCT00691210|Secondary|Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies||continuous||||||
115144|NCT00691210|Secondary|The Prevalence of Anti-tumor Activity||continuous||||||
115145|NCT00691210|Secondary|The Number of Dose Delays and Reductions at the MTD||continuous||||||
115146|NCT00691210|Secondary|The Greatest Number of Cycles Received in Each Treatment Group|The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.|up to 45 weeks|||cycles|||Number
115147|NCT00691197|Post-Hoc|Patient Preference|Percentage of patients who used pre-study rewetting drops and answered “Agree” or “Strongly Agree” when asked if they preferred the study drops (SD) over their pre-study drops(PSD).|Day 30|Responders Completed Population||Percentage of participants|||Number
115148|NCT00691197|Secondary|Corneal Staining|Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding|Day 90|Completed Population||Participants|||Number
115149|NCT00691197|Post-Hoc|Patient Acceptability|"A questionnaire was administered to all patients to evaluate the acceptability of the Rewetting Drops (RD) with use with Contact Lenses (CL). Table below shows the percentage of participants responding either Agree or Strongly Agree at day 90. Number of participants answering question is indicated as (number of Test subjects/number of Control subjects)"|Day 90|Intent to Treat Population||Percentage of Participants|||Number
115150|NCT00691197|Primary|Best Corrected Visual Acuity|Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.|Change from Baseline at Day 90|Completed Population||Percentage of Participants|||Number
115151|NCT00691093|Secondary|Reasons for Study Treatment Dose Changes|Possible change in the dose and the reasons for the change were collected and documented.|Month 3 or ET|SAS||participants|||Number
115154|NCT00691093|Secondary|Change From Baseline in Total Scores of OAB-q at Visit 4|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS||scores on a scale||Standard Deviation|Mean
115155|NCT00691093|Primary|Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4|The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS||episodes||Standard Deviation|Mean
115156|NCT00691093|Primary|Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4|UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of ‘urgency’ urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).|Baseline, Month 1, Month 2, Month 3 or ET|FAS||episodes||Standard Deviation|Mean
115157|NCT00691093|Primary|Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4|Nocturnal frequency: mean number of ‘night time’ (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of ‘night time’ urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or ET|FAS||episodes||Standard Deviation|Mean
115158|NCT00691093|Secondary|Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale|Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.|Baseline, Month 3 or ET|FAS||scores on a scale||Standard Deviation|Mean
115159|NCT00691093|Secondary|Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4|Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered ‘(2) About the same’ to question 1 then a score of 0 was given. If a subject answered ‘(1) Worse’ to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered ‘(3) Better’ to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.|Month 3 or ET|FAS||scores on a scale||Standard Deviation|Mean
115160|NCT00691093|Secondary|Clinical Global Evaluation of Fesoterodine|Clinical global evaluation of study medication was assessed via the question ‘how would you rate the study medication the patient received for overactive bladder?,’ and was assessed on the four point categorical scale, ranging from ‘Poor’ to ‘Excellent.’|12 weeks|SAS||participants|||Number
115161|NCT00691093|Secondary|Patient's Global Evaluation of Fesoterodine|The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?’ and was assessed on the four point categorical scale, ranging from ‘Poor’ to ‘Excellent'.|Baseline, Month 3 or ET|The safety analysis set (SAS) included all subjects who enrolled in the study, signed informed consent and received at least one dose of study medication.||participants|||Number
115162|NCT00691093|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4|The PVR urine volume: measured by an ultrasound scan.|Baseline, Month 1, Month 2, Month 3 or ET|FAS||ml||Standard Deviation|Mean
115163|NCT00691093|Primary|Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit|Micturition frequency: mean number of ‘day time’ (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of ‘day time’ urinations, divided by the total diary days collected at that visit.|Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)|The full analysis set (FAS) included all patients who received at least one dose of the study medication and who had at least one post baseline efficacy measurement.||episodes||Standard Deviation|Mean
115164|NCT00691054|Secondary|Median Overall Survival of Participants|Median overall survival rate of participants measured in months|12 months|||months||95% Confidence Interval|Median
115165|NCT00691054|Secondary|Number of Participants Experiencing Adverse Events||6 months||||||
115166|NCT00691054|Secondary|Progression-free Survival|Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months|||months||95% Confidence Interval|Median
115167|NCT00691054|Secondary|Number of Participants Showing Stable Disease|Number of participants showing stable disease according to RECIST 1.0 criteria|12 months|||participants|||Number
115168|NCT00691054|Secondary|Number of Participants Showing Complete or Partial Response|Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, Complete Cesponse (CR) = Disappearance of all target lesions; Partial Response (PR), >= 30% descrease in the sum of the longest diameter of target lesions; Overal Response (OR) = CR + PR.|6 months|||participants|||Number
115169|NCT00691054|Primary|Overall Survival Rate at 6 Months|Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.|6 months|||percentage of participants||95% Confidence Interval|Number
115170|NCT00691028|Secondary|Pharmacokinetics Positive- ATI|ATI (antibody to Infliximab) was measured by a modification of an enzyme immunoassay.|54 weeks|||participants|||Number
115172|NCT00691028|Secondary|Change in Modified Total Sharp Score (mTSS) at week54 From Baseline|The mTSS is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 54 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 and joint space narrowing on a scale of 0 (no damage) to 4. Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 390 [maximal disease]). An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|baseline and week 54|||score||Inter-Quartile Range|Median
115173|NCT00691028|Secondary|Change From Baseline to Week 54 in HAQ|HAQ: patient’s assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|54 weeks|||units on a scale||Standard Deviation|Mean
115174|NCT00691028|Secondary|Change From Baseline in DAS28|DAS28 is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative change score indicates improvement. Total score range:0 to 9.4, higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 to 9.4 implied high disease activity and <2.6 implied remission.|baseline and week 54|||units on a scale||Standard Deviation|Mean
115175|NCT00691028|Secondary|CRP Level|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range of CRP is 0 mg/dL to 0.3 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|54 weeks|||mg/dl||Inter-Quartile Range|Median
115176|NCT00691028|Secondary|Swollen Joint Count (SJC)|The SJC was determined by examination of 66 joints and identifying when swelling was present. The SJC was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|54 weeks|||count||Standard Deviation|Mean
115177|NCT00691028|Secondary|Tender Joint Counts (TJC)|The TJC was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The TJC was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|54 weeks|||count||Standard Deviation|Mean
115178|NCT00691028|Secondary|Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)|ACR 20 (50 or 70) response is a decrease of at least 20% (50% or 70%) in both TJC and SJC and in 3 to 5 assessments (patient's assessment of pain [VAS] with 0, no pain to 100, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 100, very poor and 0, no arthritis activity to 100, extremely active, respectively]; [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; [CRP])|54 weeks|||percentage of participants|||Number
115179|NCT00691028|Primary|Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)|The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient’s assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient’s global assessment of disease activity (VAS 0-100); c. Physician’s global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.|baseline and week 54|||percent change||Standard Deviation|Mean
115180|NCT00690898|Secondary|Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline|Acromegaly Quality of Life Assessment (AcroQoL) questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||units on a scale||95% Confidence Interval|Mean
115181|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
115182|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
115183|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
115215|NCT00690482|Secondary|COPD Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
115184|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
115185|NCT00690898|Secondary|Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline|The status of clinical signs of acromegaly assessed by an acromegaly symptoms questionnaire (paper form) completed by the patient at each study visit. The scoring for each clinical sign of acromegaly on the questionnaire is from 0 (no symptom) to 8 (severe, incapacitating symptom). The variation (or no variation) in scores indicate whether the clinical sign of acromegaly had improved, worsened or was unchanged.|Week 12, 24 and 48|Analysis based on the number (n) of subjects in the ITT population with a valid value.||percentage of subjects|||Number
115186|NCT00690898|Secondary|Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels||Week 12, 24 and 48|Analysis based on the number (n) of subjects with baseline level between 20 ng/ml and 100 ng/ml in the ITT population with a valid value.||mcg/L||Standard Deviation|Mean
115187|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.||Week 12, 24, and 48|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.||percentage change||95% Confidence Interval|Mean
115188|NCT00690898|Secondary|Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels||Week 12, 24, and 48|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population.||percentage change||95% Confidence Interval|Mean
115189|NCT00690898|Secondary|Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).||Baseline (week 1) to week 12 and week 24|Analysis based on number (n) of subjects in the Intent to Treat population (ITT) with a valid value.||participants|||Number
115190|NCT00690898|Primary|Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)|A blinded, centrally assessed evaluation of all MRIs was performed. A 20% reduction from the volume at Visit 1 was considered to be clinically relevant.|Week 1 and Week 48|Analysis based on intent-to-treat (ITT) population comprised of 89 patients.||percentage of subjects||95% Confidence Interval|Number
115191|NCT00690820|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
115192|NCT00690820|Secondary|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
115193|NCT00690820|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
115194|NCT00690820|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Number per day||Standard Deviation|Mean
115195|NCT00690820|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
115196|NCT00690820|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
115197|NCT00690820|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
115198|NCT00690820|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
115199|NCT00690794|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by the total number of patients analyzed.|Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.||percentage of patients|||Number
115200|NCT00690794|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Baseline, Day 90|Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.||Units on a scale||Standard Error|Mean
115201|NCT00690755|Primary|Alterations in PKC-zeta mRNA in Vastus Lateralis Skeletal Muscles|All muscle samples obtained by 9/30/07, final date for examination of samples 9/30/08 Muscle dependent ability to diminish blood glucose levels during insulin treatment.|PKC-zeta mRNA levels and aPKC activity in muscle evaluated 40 minutes post-insulin treatment|PKC-zeta mRNA and aPKC activity in vastus lateralis skeletal muscle was measured by analysis of gene expression levels of PKC and measuring them in relative amounts in comparison to control subjects.||arbitrary units/ng rRNA||Standard Error|Mean
115202|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|every 3 months - baseline to final visit|||mm Hg||Standard Deviation|Mean
115203|NCT00690612|Primary|Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP).|Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.|Every 3 months- baseline to final visit|||Millimeters of Mercury (mm Hg)||Standard Deviation|Mean
115204|NCT00690573|Secondary|Number of Subjects Positive for Anti-adalimumab Antibodies (AAA)|Serum samples with adalimumab concentration below 2 mcg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Week 24 and Week 60|||Participants|||Number
115205|NCT00690573|Secondary|Mean Serum Adalimumab Concentration|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL).|Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60|For the 20 mg dose, N = 8 at each timepoint. For the 40 mg dose, N = 17 at Weeks 2 and 4; N = 16 at Weeks 8, 16, and 24; N = 14 at Week 36; N = 15 at Week 48; and N = 14 at Week 60.||mcg/mL||Standard Deviation|Mean
115206|NCT00690573|Secondary|Number of Subjects Achieving PedACR 30/50/70 Responses||Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit|The analysis was conducted using the full analysis set (FAS) population (all subjects who received at least 1 dose of study drug) as observed. N=25 at Weeks 2, 4, and the Final Visit; N=24 at Weeks 8, 24, and 36; N=23 at Week 48; N=22 at Week 60; N=19 at Weeks 72 and 96; N=11 at Week 120; and N=5 at Week 144.||Participants|||Number
115207|NCT00690573|Secondary|Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16|Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug. Missing values were treated as non-responders.||Participants|||Number
115208|NCT00690573|Primary|Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16|Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug.||Participants|||Number
115209|NCT00690495|Secondary|Further Assessment of Injection Pain||during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia||||||
115210|NCT00690495|Primary|Incidence of Expression of Pain During Injection||during first propofol bolus|per protocol||participants|||Number
115211|NCT00690482|Secondary|Adverse Event|The number of participants that experienced at least one adverse event.|Up to 4 Weeks|The safety analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo.||Participants|||Number
115212|NCT00690482|Secondary|Total Use of Reliever|Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Number of inhalations per day||Full Range|Mean
115213|NCT00690482|Secondary|PEF (Peak Expiratory Flow) Evening|Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L/min||Full Range|Mean
115216|NCT00690482|Secondary|COPD Symptom Cough Score|Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
115217|NCT00690482|Secondary|COPD Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
115218|NCT00690482|Secondary|COPD Symptom Sleep Score|Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep).|Baseline and 4-week treatment period average|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
115219|NCT00690482|Secondary|FEF25%-75%|Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L/s||Full Range|Mean
115220|NCT00690482|Secondary|Inspiratory Capacity|Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
115221|NCT00690482|Secondary|Slow Vital Capacity|Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
115222|NCT00690482|Secondary|Forced Vital Capacity|Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
115223|NCT00690482|Primary|Clinical COPD Questionnaire|Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms).|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||Scores on a scale||Full Range|Mean
115224|NCT00690482|Primary|FEV1|Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)|Baseline and Week 4|The efficacy analysis is based on 117 randomized patients, 61 on AZD1981 and 56 on placebo. However, not all patients will have valid, non-missing values for a given outcome measure.||L||Full Range|Mean
115225|NCT00690443|Secondary|Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.||Baseline and 4 weeks|||Percent||Standard Deviation|Mean
115226|NCT00690443|Primary|Percent Change in LDL-C After 8 Weeks of Therapy||Baseline and 8 weeks of treatment|||Percent Change||Standard Deviation|Mean
115227|NCT00690430|Secondary|Assess the Proportion of Patients Who Achieved at Least a 30% Reduction in Frequency of Bowel Movements||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
115228|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Duration of Symptom Response||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
115229|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Progression||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
115230|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Quality of Life Assessed by FACIT-D Questionnaire||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
115231|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria|Disease control rate (DCR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline, or a new lesion; or progression of non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with analyzable data at month 6 were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
115246|NCT00689819|Primary|Clinically Significant Difference in Blood Pressure Lowering, Health Status and Quality of Life|To evaluate the ability of this program to produce (as a surrogate for heart failure prevention) a clinically significant difference in blood pressure lowering, health status and quality of life between the 2 treatment groups.|Baseline and 1 year|||mm Hg||95% Confidence Interval|Mean
115232|NCT00690430|Secondary|Objective Tumor Response Rate Assessed by Investigator|Baseline evaluations were to include Triphasic CT scan or MRI of the abdomen. Triphasic CT or MRIs were to be read by same radiologist at each assessment, measuring the same target and non-target lesions and accounting for all lesions that were present at Baseline. All known disease was accounted for when assessing objective tumor status. Current objective tumor status was to be captured on Tumor Assessment CRF. Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Month 6|Full Analysis Set (FAS) consists of all patients randomized into the study. Patients were analyzed according to the treatment they were assigned to at randomization. Patients randomized 6 months before the final clinical cutoff date were included in this analysis.||Percentage of Participants||95% Confidence Interval|Number
115233|NCT00690430|Secondary|Pasireotide LAR vs. Octreotide LAR on Time to Symptom Response.||Month 6|This Outcome Measure was planned in the protocol but not included in the analysis due to early termination of study due to lack of efficacy in symptom control.|||||
115234|NCT00690430|Secondary|Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in total number of flushing episodes comprising Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. total number of flushing episodes at Baseline) and randomization stratum (D+F or F) as covariates.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients were analyzed according the treatment they were assigned to at randomization. (ITT) principle.||Percentage of Episodes||Standard Deviation|Mean
115235|NCT00690430|Secondary|Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.|Percent change from Baseline in mean daily bowel movements at Month 6 were compared between the two treatment groups using ANCOVA model with treatment as the main effect and symptom levels at Baseline (e.g. mean daily bowel movement at Baseline) and randomization stratum (D+F or D) as covariates. Percentage change = (Month 6 - baseline)/baseline.|6 months|The Efficacy analyzable set consists of the subset of FAS patients who were randomized at least six months prior to the futility DMC data cut-off. Patients who had symptoms at baseline and at 6 months were included in this analysis.||Percentage of Episodes||Standard Deviation|Mean
115236|NCT00690430|Primary|Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.|Percentage of patients who received clinical benefit in symptom (diarrhea and/or flushing) improvement as: Diarrhea (D)+Flushing (F): Patients with a daily mean number (#) of at least four bowel movements and a total of five or more flushing episodes. Clinical Benefit Response Criteria (CBRC): <4 daily mean bowel movements AND at least 20% reduction from Baseline in the daily mean # of bowel movements AND any reduction in the total # of flushing episodes compared with Baseline. (D) Patients with a daily mean # of at least four bowel movements and a total # of <5 flushing episodes. (CBRC) <4 daily mean bowel movements AND at least a 20% reduction from Baseline in the daily mean # of bowel movements. (F) Patients with a total # of at least 14 flushing episodes and a daily mean # of <4 bowel movements (CBRC) At least a 30% reduction from Baseline in the total # of flushing episodes.|Month 6|The Efficacy analyzable set consists of subset of FAS patients who were randomized at least six months prior to futility interim analysis data cut-off. It is for the primary efficacy analysis and secondary efficacy analysis except for tumor response assessment. Data reported was based on randomized patients at the time of the interim analysis.||Percentage of Participants||95% Confidence Interval|Number
115237|NCT00690339|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale.|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating||units on a scale||Standard Deviation|Mean
115238|NCT00690339|Primary|Local Complications|By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts|10 years|||Percentage of Patients||95% Confidence Interval|Number
115239|NCT00690040|Secondary|To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups||At the end of the study||||||
115240|NCT00690040|Primary|Average Time in Hours From Insertion of the Catheter Until Delivery||At the end of the study|||HOURS||Standard Deviation|Mean
115241|NCT00689884|Secondary|Assess the Per-patient Costs Related to Pegfilgrastim Use in the Mobilization of Autologous PBSCs in 16 Study Participants.|Costs will be divided into three categories: 1. Pre-pheresis preparation (cost of Pegfilgrastim, laboratory testing, drug administration, providers, line placement); 2. Pheresis procedure (costs related to # collections and total hours on apheresis machine, microbiological testing, provider, CD34 analysis and related labs, cryopreservation/storage and complications); 3. Post-pheresis processing (cost of stem cell thawing, microbiological testing, CD34 analysis and related labs, providers, administration).|At each stage of pheresis for each enrolled subject for a maximum of 2 years.|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|||||
115242|NCT00689884|Primary|Efficacy of Pegfilgrastim in the Mobilization of Autologous Peripheral Blood Stem Cells (PBSCs), Defined as Cell Yield ≥ 3 x 10e6 CD34+/kg|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|2 years|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.|||||
115243|NCT00689871|Secondary|Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale|Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied|10 years|All patients who had a breast implant satisfaction rating||units on a scale||Standard Deviation|Mean
115244|NCT00689871|Primary|Local Complications|By patient risk of complications occuring in at least 5% of patients in 1 or more cohorts|10 years|all enrolled patients||percentage by patient||95% Confidence Interval|Number
115245|NCT00689819|Secondary|Change in Prevalence of PCCD|To measure the change from baseline to 1 year prevalence of pre-clinical cardiac dysfunction in randomized study patients.|Baseline and 1 year|||percentage of participants|||Number
115247|NCT00689793|Secondary|Adherence to Treatment.|Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland)|4 weeks|||percentage of day||Standard Deviation|Mean
115248|NCT00689793|Secondary|Response of Iron Supplementation on Mental Disorder|Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score >15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or <15) after placebo or treatment.|baseline and 4 weeks|Number of participant was set according the primary outcome.||participants|||Number
115249|NCT00689793|Secondary|Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test|Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate.|baseline and 4 weeks|||mLO2/kg/min||Standard Deviation|Mean
115250|NCT00689793|Secondary|Ferritin Change Before and After 4 Weeks of Treatment/Placebo|Level of ferritin measured 4 weeks after randomization|baseline and 4 weeks|||ng/mL||Standard Deviation|Mean
115251|NCT00689793|Secondary|Hemoglobin Variation Before and After Treatment vs Placebo|The level of hemoglobin measured 4 weeks after randomization|baseline and 4 weeks|The number of participants was calculated according to the primary outcome.||g/L||Standard Deviation|Mean
115252|NCT00689793|Primary|Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.|"The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from no fatigue=0 to very severe fatigue=10."|baseline and 4 weeks|The sample size for randomized volunteers was calculated using a two-sample comparison of means to detect a one point difference in the visual analogical scale (first outcome).||centimeter||Standard Deviation|Mean
115253|NCT00689611|Secondary|Composite Major Adverse Cardiovascular Events (MACE)|"All clinical end points were adjudicated by members of the Endpoints Evaluation Committee who were blinded to treatment assignment.~Composite MACE (death, myocardial infarction, unstable angina)"|12 months|||percentage of participants|||Number
115254|NCT00689611|Primary|Smoking Abstinence|"The primary end point was 7-day point prevalence smoking abstinence at 12 months. Smoking cessation was defined as self-reported abstinence in the week before the 12-month clinic visit and a measurement of exhaled carbon monoxide less than 11 ppm.~The primary end point was analyzed on an intention-to-treat (ITT) basis. Our ITT analysis assumed that those who withdrew consent or were lost to follow-up had returned to smoking at their baseline rates. This assumption is common in smoking cessation trials."|12 months|||percentage of participants|||Number
115255|NCT00689481|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 Weeks|ITT||participants|||Number
115256|NCT00689481|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 Weeks|ITT||participants|||Number
115257|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 Weeks|ITT||participants|||Number
115258|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2-grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 Weeks|ITT||participants|||Number
115259|NCT00689481|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 Weeks|ITT||participants|||Number
115260|NCT00689481|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population||participants|||Number
115269|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
115261|NCT00689390|Primary|Number of Participants That Discontinued the LTFU Due to SAEs|An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.||participants|||Number
115262|NCT00689390|Primary|Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU|Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.|From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)|All enrolled participants were included in safety analyses.||participants|||Number
115263|NCT00689390|Primary|Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci|Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS).|From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years)|All participants with TE-RAVs who received at least one dose of study medication in a previous Phase 1, 2, or 3 boceprevir or narlaprevir clinical study. Participants could have had more than one TE-RAV. All TE-RAVs were observed in participants in the boceprevir studies (i.e. none of the participants in the narlaprevir study had a TE-RAV).||participants|||Number
115264|NCT00689390|Primary|Kaplan-Meier Exposure-adjusted Relapse Rate|The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year].|From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.||relapses per 1,000 person-years|||Number
115265|NCT00689390|Primary|Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response)|Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU.|From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)|All participants who were sustained responders at 24 weeks post-treatment in the previous study and who had available data were included in the analysis.||participants|||Number
115266|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
115267|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
115268|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.||percentage of participants|||Number
115270|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
115271|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
115272|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
115273|NCT00689351|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.||percentage of participants|||Number
115274|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the Toddler Dose (13 months of age)|Evaluable Toddler Immunogenicity Population||Mcg/mL||95% Confidence Interval|Geometric Mean
115275|NCT00689351|Other Pre-specified|Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series|Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity Population||Mcg/mL||95% Confidence Interval|Geometric Mean
115276|NCT00689351|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations||percentage of participants||95% Confidence Interval|Number
115277|NCT00689351|Primary|Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).|1 month after the infant series (7 months of age)|Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.||percentage of participants||95% Confidence Interval|Number
115278|NCT00689338|Secondary|Time to Successful Intensive Care Unit (ICU) Discharge|Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.|Day 1 up to Day 56|MITT. N = participants who had a successful ICU discharge.||days||95% Confidence Interval|Mean
115279|NCT00689338|Secondary|Day 90 Survival|Percentage of participants known or assumed to be alive on Day 90.|Day 90|MITT||percentage of participants||95% Confidence Interval|Number
115280|NCT00689338|Secondary|Time to First Negative Blood Culture|Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.|Day 1 up to Day 42|MITT. N = participants who received a minimum of 3 days of dosing with anidulafungin, excluding participants who experienced invasive candidiasis either at baseline or while on anidulafungin and participants who did not have a first negative blood culture by EOIVT.||days||95% Confidence Interval|Mean
115281|NCT00689338|Secondary|Percentage of Participants With Global Response Success 6 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)|MITT; N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
115282|NCT00689338|Secondary|Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)|MITT; N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
115283|NCT00689338|Secondary|Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|EOIVT (Day 10 up to Day 42)|MITT; N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
115284|NCT00689338|Primary|Percentage of Participants With Global Treatment Response Success at End of Treatment|Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).|End of Treatment (Day 14 to Day 56)|Modified Intent-To-Treat (MITT) analysis set: all participants in the ITT population with confirmed diagnosis of candidemia or invasive candidiasis, documented within 96 hours prior to initiation of study treatment or 48 hours after commencing treatment. N excludes participants with missing or unknown global responses.||percentage of participants||95% Confidence Interval|Number
115285|NCT00689299|Primary|Scores on a Scale (Average of Total Symptom Scores)|"Sum of individual symptoms scores, 7 items, 21 points maximum~Total Symptom Scores during environmental chamber exposures at week 20. The Total Symptom Score was defined as the sum of the scores from the following seven symptoms rated 0-3 (0=absent, 1=mild, 2= moderate, 3=severe): runny nose, sneezing, itching nose, nasal congestion, watery eyes, itchy eyes, and itchy ears/palate/throat.~Total Symptom score could range from 0-21; the lower the score, the more favorable the outcome. Each symptom parameter was graded by the study subject every 10 minutes for up to 60 minutes during the baseline (Day 0) and during the Week 20 environmental chamber exposures."|20 weeks|Modified Intent to Treat. All subjects with at least 1 symptom assessment during post treatment chamber exposure||Scores on a scale||Standard Deviation|Mean
115286|NCT00689260|Secondary|Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.||Participants|||Number
115287|NCT00689260|Secondary|Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.||Participants|||Number
115288|NCT00689260|Secondary|Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the Easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.||Participants|||Number
115289|NCT00689260|Primary|Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)||90 Days|The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. Seven subjects who had damaged devices or incorrect device setting were excluded from this analysis set.||Percent of injections missed||Full Range|Median
115290|NCT00689221|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Up to 50 months|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section.|||||
115291|NCT00689221|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
115292|NCT00689221|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date (19 Nov 2012)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||Participants|||Number
115293|NCT00689221|Secondary|Number of Participants With Change From Baseline in Work Status at End of Study|Number of participants with change from baseline in work status (working full time [FT], part-time [PT], unemployed/retired [U/R]) at end of study (EOS) (up to cut-off date, [19 Nov 2012]) was reported. For the category ‘part-time’, the following sub-categories were defined: part-time due to basic disease (PT1); part-time not due to basic disease (PT2); part-time reason not known (PT3).|Baseline, End of study (up to cut-off date, [19 Nov 2012])|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.||participants|||Number
115294|NCT00689221|Secondary|EuroQol 5-Dimensions (EQ-5D) Questionnaire Index|The EuroQuol-5D (EQ-5D) questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.594 (death) and the highest is 1.00 (full health).|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
115295|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Brain Module (EORTC QLQ-BN20) Sub-scale Scores|The QLQ-BN20 is a questionnaire specifically designed as the QLQ-C30 supplement for the evaluation of quality of life in brain tumor participants. It includes 4 multi-item sub-scales: future uncertainty, visual disorder, motor dysfunction, communication deficits, and 7 single-item scales: headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs, and bladder control. All items are rated on a 4-point Likert-type scale (‘1=not at all’, ‘2=a little’, ‘3=quite a bit’ and ‘4=very much’), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.||units on a scale||Standard Deviation|Mean
115296|NCT00689221|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Sub-scale Scores|The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|Up to 50 months|ITT population included all the participants who were randomized to study treatment. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category.||units on a scale||Standard Deviation|Mean
115297|NCT00689221|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 6 Hours (AUC [0-6]) After Dose|The AUC (0-6) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."||hour*ng/mL||Standard Deviation|Mean
115298|NCT00689221|Secondary|Time to Maximum Plasma Concentration (Tmax)|The Tmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."||hours||Standard Deviation|Mean
115299|NCT00689221|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2.1.|Day 1 of Week -1|"Analysis population included all participants of Cilengitide + Temozolomide + Radiotherapy group who received at least 1 cilengitide dose with plasma concentration data available on Day 1 of Week -1."||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
115396|NCT00688740|Primary|Number of Participants With Disease-Free Survival Events|Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.|up to 10 year follow-up|The study was originally designed to have 90% power to detect a 26% risk reduction of relapsing for TAC compared to FAC (hazard ratio=0.74)||Participants|||Number
115300|NCT00689221|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|"The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site and Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). Investigator’s assessed progression according to MacDonald criteria and IRC by Response Assessment in Neuro-Oncology Working Group (RANO) criteria using Gadolinium-enhanced magnetic resonance imaging.~Investigator and IRC read: Progression is defined as greater than 25 percent increase in the sum of the product of the largest perpendicular diameters of enhancing tumor compared to the smallest prior sum, or Worsening of an evaluable lesion(s),or Marked increase in T2/FLAIR non-enhancing lesions (IRC only) or Any new lesion"|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
115301|NCT00689221|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012)|ITT population included all the participants who were randomized to study treatment.||Months||95% Confidence Interval|Median
115302|NCT00689117|Secondary|The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12|The ISGA is a static (“snap-shot”) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.|Week 12|ITT Population||percentage of participants|||Number
115303|NCT00689117|Secondary|The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12|The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.|Week 12|ITT Population||participants|||Number
115304|NCT00689117|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|ITT Population||percent change||Standard Deviation|Mean
115305|NCT00689117|Primary|The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|The ISGA is a static (“snap-shot”) evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.|Baseline, Week 12|ITT Population||percentage of participants|||Number
115306|NCT00689117|Primary|Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)|Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.|Baseline, Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.||lesions||Standard Deviation|Mean
115307|NCT00689104|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
115308|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
115309|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
115310|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
115311|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Deviation|Mean
115312|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D)Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115313|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115314|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115315|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115316|NCT00689104|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115324|NCT00689104|Secondary|Percentage of Participants With Zero Incontinence Episodes at Week 4, Week 8, Week 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
115317|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percent activity impairment||Standard Deviation|Mean
115318|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent overall work impairment||Standard Deviation|Mean
115319|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent impairment while working||Standard Deviation|Mean
115320|NCT00689104|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent work time missed||Standard Deviation|Mean
115321|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was utilized for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||Scores on a scale||Standard Error|Least Squares Mean
115322|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||Scores on a scale||Standard Error|Least Squares Mean
115323|NCT00689104|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||percentage of participants|||Number
115351|NCT00689091|Secondary|Incidence of Post-traumatic Stress Disorder.||Outcome of post-traumatic stress disorder as it relates to awareness is assessed||||||
115352|NCT00689091|Secondary|Meta-Analysis of Awareness Events in Conjunction With the BAG-RECALL Study Based at Washington University.||Outcome of awareness is assessed||||||
115325|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||pads||Standard Error|Least Squares Mean
115326|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||nocturia episodes||Standard Error|Least Squares Mean
115327|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."||Scores on a scale||Standard Error|Least Squares Mean
115328|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Urgency episodes||Standard Error|Least Squares Mean
115329|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.||Urgency incontinence episodes||Standard Error|Least Squares Mean
115330|NCT00689104|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.||mL||Standard Error|Least Squares Mean
115331|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.||micturitions||Standard Error|Least Squares Mean
115353|NCT00689091|Primary|The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups.|By modified intention-to-treat analysis|Outcome of awareness is assessed 30-days after the operation|||Percentage of participants/30days||95% Confidence Interval|Number
115365|NCT00689052|Secondary|The Proportion of Patients “Very Much Improved” or “Much Improved” on the Patient’s Global Impression of Improvement (PGI-I) 7-point Scale|"PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment.~The score ranges from 1 = very much improved to 7 = very much worse"|Week 29 (at the end of the maintenance phase)|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115332|NCT00689104|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.||Incontinence episodes||Standard Error|Least Squares Mean
115333|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.||micturitions||Standard Error|Least Squares Mean
115334|NCT00689104|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not utilized in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
115335|NCT00689104|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The Full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||mL||Standard Error|Least Squares Mean
115336|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.||micturitions||Standard Error|Least Squares Mean
115337|NCT00689104|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (final visit)|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.||Incontinence episodes||Standard Error|Least Squares Mean
115338|NCT00689091|Secondary|Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence.||Outcome of awareness will be assessed||||||
115339|NCT00689091|Secondary|Comparison of Retrospective vs. Prospective Approaches to Assessing the Incidence of Awareness||Outcome of awareness will be assessed||||||
115340|NCT00689091|Secondary|Anesthetic Induction Doses, Hypotension, and BIS Values.||Outcome of hypotension in relationship to induction doses and BIS values will be assessed||||||
115341|NCT00689091|Secondary|Incidence of Post-operative Nausea and Vomiting in Relationship to BIS Values.||outcome of post-operative nausea and vomiting will be assessed||||||
115342|NCT00689091|Secondary|PACU Pain Scores, Neurologic Exam, and Discharge Time in Relationship to BIS Values.||Outcome of pain scores, neurologic exam and discharge time will be assessed||||||
115343|NCT00689091|Secondary|Overall Use of Anesthetics Comparing the BIS to MAC Alerts.||Anesthetic dosing will be assessed||||||
115344|NCT00689091|Secondary|BIS Values and Anesthetic Dosing of Chronic Pain Patients.||Outcome of chronic pain patients will be assessed||||||
115345|NCT00689091|Secondary|Effect of Electronic Alerts on the Clinical Behavior of the Anesthesia Provider.||Outcome of the number of electronic alerts generated is assessed||||||
115346|NCT00689091|Secondary|Analysis of Interrupted Monitoring During the Use of the BIS.||Outcome of BIS monitoring is assessed||||||
115347|NCT00689091|Secondary|Relationship Between BIS Values and Hemodynamic Parameters.||Outcome of hemodynamic stability is assessed||||||
115348|NCT00689091|Secondary|The Relationship Between Cumulative Deep Hypnotic Time, Anesthetic Doses, and Mortality.||Outcome of mortality is assessed||||||
115349|NCT00689091|Secondary|Incidence and Type of Dreams During Anesthesia in Conjunction With MAC or BIS Values.||Outcomes of dreams is assessed||||||
115350|NCT00689091|Secondary|Predictors of Post-traumatic Stress Disorder Based on the Type of Awareness Event.||Outcome of post-traumatic stress disorder is assessed with the covariate of awareness||||||
115354|NCT00689052|Secondary|Change From Baseline in Mean Tender Point Threshold|The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115355|NCT00689052|Secondary|Frequency of Rescue Medication for Pain|Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.|Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115356|NCT00689052|Secondary|Clinical Global Impression of Severity (CGI-S Scores)|Clinical Global Impression of Severity (CGI-S) Scale is a clinician’s assessment of patient’s severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115357|NCT00689052|Secondary|Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline)|The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115358|NCT00689052|Secondary|Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline)|The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115359|NCT00689052|Secondary|Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline)|The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient’s health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115360|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .~SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).~Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.~Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115361|NCT00689052|Secondary|Hospital Anxiety and Depression Scale (HADS) (Change From Baseline).|The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115362|NCT00689052|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline)|"FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week.~The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115363|NCT00689052|Secondary|The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale|11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain .|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115364|NCT00689052|Secondary|The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline).|"The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .~SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).~Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.~Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1"|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115366|NCT00689052|Primary|The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale|The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)|Baseline and Week 29|FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))|||||
115367|NCT00689026|Primary|The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.|The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial.|The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours|13 patients were excluded from the Experimental Arm (12 cancelled their appointment and 1 did not complete the prep) and 6 were excluded from the Control Arm (5 cancelled their procedure and 1 withdrew from the trial) therefore results were analyzed and compared using the chi-square statistics-Validated Aronchik colonoscopy cleansing grading scale.||percentage of patients|||Number
115368|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
115369|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
115370|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
115371|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 months of age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
115372|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (15 months of age)|Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
115373|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 3 of the infant series (6 months of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
115374|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 Days after Dose 2 of the infant series (4 months of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||percentage of participants|||Number
115375|NCT00688870|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after Dose 1 of the infant series (2 Months of Age)|Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
115395|NCT00688740|Secondary|Number of Participants With Overall Survival Events|Overall Survival - time from the date of randomization up to the date of death of any cause.|up to 10 year follow-up|||Participants|||Number
115376|NCT00688870|Other Pre-specified|GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
115377|NCT00688870|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
115378|NCT00688870|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after toddler dose (16 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||percentage of participants||95% Confidence Interval|Number
115379|NCT00688870|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||percentage of participants||95% Confidence Interval|Number
115380|NCT00688844|Other Pre-specified|Change From Baseline in Serotonin at 12 Months|Objective: 1 year prospective cohort of PKU patients introduced to sapropterin (Kuvan)to evaluate peripheral neurotransmitter changes across time.|Baseline and 12 months||||||
115381|NCT00688844|Primary|Change From Baseline in Phenylalanine Intake at 12 Months|Total dietary phenylalanine assessed through 3-day food records - calculated as average phenylalanine intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.||grams per day||Standard Deviation|Mean
115382|NCT00688844|Primary|Change From Baseline in Total Dietary Protein Intake at 12 Months|Total dietary protein intake assessed through 3-day food records - calculated as average protein intake (grams/day) in the 3 days recorded|Baseline and 12 months|Dietary intake not submitted by 11 participants at 12 months.||grams per day||Standard Deviation|Mean
115383|NCT00688844|Primary|Change From Baseline in Plasma Phenylalanine at 12 Months|Full amino acid panel, including phenylalanine, analyzed in fasting plasma samples.|Baseline and 12 months|||Micromoles per liter||Standard Deviation|Mean
115384|NCT00688844|Primary|Change From Baseline in Percent (%) Fat Mass at 12 Months|Percent fat mass measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants||Percent Fat Mass||Standard Deviation|Mean
115385|NCT00688844|Primary|Change From Baseline in Percent (%) Lean Mass at 12 Months|% lean mass was measured via dual energy x-ray absorptiometry (DXA)|Baseline and 12 months|Data missing for 3 participants||Percent Lean Mass||Standard Deviation|Mean
115386|NCT00688844|Primary|Change From Baseline in Bone Mineral Density (BMD) at 12 Months|Change in bone mineral density (BMD) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 3 participants||grams/centimeter^2||Standard Deviation|Mean
115387|NCT00688844|Primary|Change From Baseline in BMI at 12 Months|Change in Body mass index (BMI) from baseline of Kuvan study to 12 months post-baseline|Baseline and 12 months|Data missing for 2 participants||kg/m^2||Standard Deviation|Mean
115388|NCT00688753|Secondary|Incidence of Adverse Events, Serious Adverse Events, and Death.||End of trial|Safety Set||% participants|||Number
115389|NCT00688753|Secondary|Median Progression Free Survival|PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.|End of trial|||days||95% Confidence Interval|Median
115390|NCT00688753|Secondary|Duration of Response|The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.|End of trial|In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria||days||95% Confidence Interval|Median
115391|NCT00688753|Secondary|Objective Response Rate|ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression|End of trial|||% participants||90% Confidence Interval|Number
115392|NCT00688753|Secondary|Disease Control Rate (SD + PR + CR)|DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR|6 mos|PP,ITT||% Participants||90% Confidence Interval|Number
115393|NCT00688753|Primary|To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.|PFSR at 6 months based on central review|6 mos|PP, PPFF, ITT||% participants||80% Confidence Interval|Number
115394|NCT00688740|Secondary|Number of Participants With Second Primary Malignancies (Toxicity)|Toxicity (second primary malignancies)- defined as histopathologically proven cancer, excluding nonmelanomatous skin cancer, in situ carcinoma of the cervix, and in situ carcinoma of the breast.|up to 10 year follow-up|||Participants|||Number
115397|NCT00688701|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.||participants|||Number
115398|NCT00688701|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||percentage of participants|||Number
115399|NCT00688701|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 12|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
115400|NCT00688701|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period|Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: >270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: >240 mg/dL (13.3 mmol/L). For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 12|mITT population.||percentage of participants|||Number
115401|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
115402|NCT00688701|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 12|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of participants|||Number
115403|NCT00688701|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
115404|NCT00688701|Secondary|Change From Baseline in Body Weight at Week 12|Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.||kilogram||Standard Error|Least Squares Mean
115405|NCT00688701|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|Subgroup for standardized meal test. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.||mmol/L||Standard Error|Least Squares Mean
115831|NCT00684671|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache and temperature (above 37 degree Celsius).|During the 4-day follow-up period after the challenge dose.|||Subjects|||Number
115406|NCT00688701|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 12|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.||percentage of hemoglobin||Standard Error|Least Squares Mean
115407|NCT00688688|Secondary|Safety as Assessed by Adverse Events (AEs), Vital Signs, Laboratory Tests, Physical Examination and Electrocardiogram|"An abnormality identified during a medical test was defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant. The Investigator assessed each AE for causal relationship (not related, possible or probable) to study drug. A serious AE (SAE) was any untoward medical occurrence that: resulted in death, was life-threatening, resulted in significant disability/incapacity or congenital anomaly/birth defect, required or prolonged hospitalization or was a medically important event.~The data reported represent the number of participants with adverse events in each category."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.||participants|||Number
115408|NCT00688688|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
115409|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician’s office during the 4 weeks prior to each study visit (excluding study visits) because of the patient’s bladder condition.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
115410|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||scores on a scale||Standard Deviation|Mean
115411|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115412|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115435|NCT00688662|Secondary|Percentage of Patients With a Successful Primary Outcome, Out of Those With Abnormal Sphincter Manometry.|Successful outcome was defined using the primary outcome definition of success at 12 months post randomization. Abnormal sphincter manometry was determined as a basal pressure of more than 40mm Hg in both leads.|1 year|Participants with abnormal sphincter manometry||percentage of participants with success|||Number
115478|NCT00687973|Secondary|Change From Baseline of Augmentation Index (Aix) at Week 8|To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.|Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||Ratio||Standard Error|Least Squares Mean
115413|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115414|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115415|NCT00688688|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and evaluating health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
115416|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline value. LOCF was used for the Final Visit analysis.||Percent activity impairment||Standard Deviation|Mean
115417|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||Percent overall work impairment||Standard Deviation|Mean
115418|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||Percent impairment while working||Standard Deviation|Mean
115419|NCT00688688|Secondary|Change From Baseline to Months 3, 6, 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Months 3, 6 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||Percent work time missed||Standard Deviation|Mean
115479|NCT00687973|Secondary|Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||mmHg||Standard Error|Least Squares Mean
115420|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Treatment Satisfaction-visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled ‘No, not at all’ on the left (=0) to ‘Yes, completely satisfied’ on the right (=10). A positive change from baseline indicates improvement. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
115421|NCT00688688|Secondary|Change From Baseline to Month 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Month 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
115422|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
115423|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the patient on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit.||scores on a scale||Standard Error|Least Squares Mean
115424|NCT00688688|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
115425|NCT00688688|Secondary|Percentage of Participants With Zero Incontinence Episodes at Months 1, 3, 6, 9 and 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.||percentage of participants|||Number
115426|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 nocturia episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.||nocturia episodes||Standard Error|Least Squares Mean
115427|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in the Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate."|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients who had at least 1 use of a pad at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit||pads||Standard Error|Least Squares Mean
115428|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS means are generated from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 postbaseline micturition measurement in the visit diary. N is the number of patients included at each time point. LOCF is used for the Final Visit analysis.||scores on a scale||Standard Error|Least Squares Mean
115429|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could delay voiding a short time; 3=Severe urgency, could not delay voiding; 4=Urge incontinence, leaked before arriving to the toilet. LS means are from an ANCOVA model with treatment group, previous study history, gender & geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary. This analysis includes patients with at least 1 urgency episode at Baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.||urgency episodes||Standard Error|Least Squares Mean
115430|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0=No urgency; 1=Mild urgency; 2=Moderate urgency, could postpone voiding a short time; 3=Severe urgency, could not postpone voiding; 4=Urge incontinence, leaked before arriving to toilet. LS means are from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 urgency incontinence episode at baseline. N is the number of patients included at each time point. LOCF is used for the Final Visit.||urgency incontinence episodes||Standard Error|Least Squares Mean
115431|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. LS means were generated from the ANCOVA model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.||mL||Standard Error|Least Squares Mean
115432|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set-Incontinence included all patients who took at least 1 dose of double-blind study drug with a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. N is the number of patients included at each time point. LOCF was used for the Final Visit analysis.||incontinence episodes||Standard Error|Least Squares Mean
115433|NCT00688688|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and Final Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and months 1, 3, 6, 9 and 12/end of treatment. Least squares (LS) means were generated from the analysis of covariance (ANCOVA) model with treatment group, previous study history, gender and geographical regions as fixed factors and baseline as a covariate.|Baseline and Months 1, 3, 6, 9 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug with a baseline and at least 1 post baseline micturition measurement in the visit diary. N is the number of patients included in the analysis at each time point. Last observation carried forward (LOCF) was used for the Final Visit analysis.||micturitions||Standard Error|Least Squares Mean
115434|NCT00688688|Primary|Number of Participants With and Severity of Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a study drug and which did not necessarily have a causal relationship with the treatment. The investigator assessed the severity of each AE, including abnormal laboratory values, as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities."|From the first dose of double-blind study drug up until 30 days after the last dose of study drug, up to 13 months.|The number of participants analyzed represents the Safety Analysis Set (SAF), including all randomized patients who took at least one dose of double-blind study drug.||participants|||Number
115480|NCT00687973|Secondary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)||Baseline and Week 8|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||mmHg||Standard Error|Least Squares Mean
115436|NCT00688662|Primary|Percentage of Participants With Success|The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of <6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the window, then the 6-month value was used when available.|1 year|The primary analysis was conducted with the intention-to-treat population defined as all randomized patients.||percentage of paricipants with success||95% Confidence Interval|Number
115437|NCT00688636|Secondary|Mean Erythrocyte Sedimentation Rate|erythrocyte sedimentation rate value - blood test|one year|||mm/h||Full Range|Median
115438|NCT00688636|Secondary|C-reactive Protein Concentration as a Surrogate Marker of Inflammation|The CRP was obtained at each study visit as a surrogate marker of inflammation. The CRP was recorded as milligram per deciliter (mg/dl). A normal CRP was 0-0.8 mg/dl; levels exceeding 0.8 mg/dl indicated inflammation.|one year|||mg/dL||Full Range|Median
115439|NCT00688636|Secondary|Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis|Histologic recurrence based on a histologic activity score and the presence of polymononuclear cells. The maximum score is 14 per biopsy site.|One year|Histologic activity score||participants|||Number
115440|NCT00688636|Secondary|Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200|The Crohn's Disease Activity Index (CDAI) is calculated by a measurement of symptoms, signs, and lab tests over a time period of the previous 7 days. The CDAI includes: Number of very soft stools; sum of abdominal pain ratings: (0=none, 1= mild, 2=moderate, 3=severe); general well being (0=well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible); Symptoms or findings presumed related to Crohn's disease (present): arthritis or arthralgia, iritis or uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, anal fissure, fistula or perirectal abscess, other bowel related fistula, febrile episode over 100 degrees during past week, taking lomotil or opiates for diarrhea, abnormal mass (0=none; 0.4=questionable; 1=present) hematocrit [(typical-current) X 6] Normal average male = 47, female =42, body weight|One year|CDAI score > 200||participants|||Number
115441|NCT00688636|Primary|Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year|Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts’ Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.|one year|The proportion of patients with endoscopic recurrence (> or = i2) at 1 year after surgery||participants|||Number
115442|NCT00688545|Primary|JIA Concomitant Medications|JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.|Year 2 or early termination|Safety Analysis Set subset of participants who received JIA concomitant medications||Participants|||Number
115443|NCT00688545|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.|Baseline up to 2 years|Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment.||Participants|||Number
115444|NCT00688519|Secondary|Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|ITT||participants|||Number
115445|NCT00688519|Secondary|Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.|8 weeks|ITT||participants|||Number
115446|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8|Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.|8 weeks|ITT||participants|||Number
115447|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.|8 weeks|ITT||participants|||Number
115448|NCT00688519|Secondary|Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8|Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.|8 weeks|ITT||participants|||Number
115449|NCT00688519|Primary|Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)|Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.|8 weeks|Intent-to-Treat (ITT) Population||particpants|||Number
115450|NCT00688467|Secondary|Number of Participants Discontinued From the Study Because of an Adverse Event|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. Discontinuations due to an AE are reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug||Participants|||Number
115451|NCT00688467|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to study drug. AEs were reported based on the study drug taken at the time of the event.|Up to 48 days|The population analyzed included all participants who received study drug||Participants|||Number
115452|NCT00688467|Secondary|Change From Baseline in Sputum Eosinophil Cationic Protein (ECP) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. ECP level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|ECP level was not analyzed because too few evaluable samples were collected|||||
115453|NCT00688467|Secondary|Change From Baseline in Sputum Myeloperoxidase (MPO) Level After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. MPO level was measured in the sputum supernatant.|Baseline and 7 and 24 hours after allergen challenge|MPO level was not analyzed because too few evaluable samples were collected|||||
115454|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophil Elastase After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. Neutrophil elastase activity was measured in the sputum supernatant as milli units/mL (mU/mL). Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples||mU/mL||Standard Deviation|Least Squares Mean
115455|NCT00688467|Secondary|Change From Baseline in Sputum Interleukin 8 (IL-8) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were to be collected via the nebulized method. IL-8 level was measured in the sputum supernatant. Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples||pg/mL||Standard Deviation|Least Squares Mean
115456|NCT00688467|Secondary|Change From Baseline in Peripheral Blood Eosinophil Count After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Baseline values were determined at 24 hours before allergen challenge in each treatment period. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and had evaluable blood samples available||Percent change from baseline||Standard Deviation|Least Squares Mean
115457|NCT00688467|Secondary|Change From Baseline in Sputum Neutrophils After Allergen Challenge Following 9 Days Pretreatment With Navarixin|Induced sputum samples were collected via the nebulized method. Baseline values were determined at 24 hours before allergen challenge in each treatment period. Sputum neutrophils were measured as percent of total white blood cells. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 7 and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods and were able to produce evaluable sputum samples||Percent change from baseline||Standard Deviation|Least Squares Mean
115458|NCT00688467|Secondary|Maximum Percent Change From Baseline in FEV1 During the Early Asthmatic Response Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. The EAR was 0 to 2 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Percent change from baseline||Standard Deviation|Least Squares Mean
115459|NCT00688467|Secondary|Percent Change From Baseline in FEV1 Area Under the Curve From 0 to 2 Hours (AUC0-2hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of Early Asthmatic Response (EAR) between 0 to 2 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. A percent change >0 indicates a reduction in FEV1 from before to after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 0 to 2 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Percent change from baseline||Standard Deviation|Least Squares Mean
115460|NCT00688467|Secondary|Change in Concentration of Methacholine That Initiated a 20% Reduction in FEV1 From 24 Hours Before (Baseline) to 24 Hours After Allergen Challenge|This is a measure of allergen-induced changes in airway responsiveness to methacholine. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and 24 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Log methacholine (mg/mL)||Standard Deviation|Least Squares Mean
115461|NCT00688467|Secondary|Maximum Change From Baseline in FEV1 During the LAR Following 9 Days of Pretreatment With Navarixin|Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. The LAR was 3 to 7 hours after allergen challenge. The reported SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Liters||Standard Deviation|Least Squares Mean
115462|NCT00688467|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 3 to 7 Hours (AUC3-7hr) After Allergen Challenge Following 9 Days Pretreatment With Navarixin|This is a measure of the Late Asthmatic Response (LAR) between 3 and 7 hours after allergen challenge. Allergen challenge was administered 1 hour after the ninth daily dose of study drug in each treatment period. Baseline FEV1 was defined as the prechallenge FEV1 in the treatment period. A percent change >0 indicates a fall in FEV1 after allergen challenge. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance using pooled SD values is the assumption that the SDs are similar across treatment groups. The pooled SD values were used in the calculation of test statistics to assess treatment differences (p-value generation).|Baseline and between 3 and 7 hours after allergen challenge|The population analyzed included all participants who completed both treatment periods||Percent change from baseline||Standard Deviation|Least Squares Mean
115463|NCT00688103|Primary|Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score|"The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively.~Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet.~For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, <50% of the original joint space; 3=general, >50% of the original joint space or subluxation; 4=ankylosis."|at 52 weeks|||units on a scale||Standard Deviation|Mean
115464|NCT00688103|Primary|ACR50 Response Rate|ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).|at 24 weeks|||percentage of responders|||Number
115465|NCT00688103|Primary|EULAR Good Response|EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by > 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 < 3.2 is regarded as low disease activity.|at 24 weeks|||percentage of responders|||Number
115466|NCT00688064|Secondary|Percent of Subjects With Adverse Events|Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period)|Up to 12 weeks|ITT||% of subjects|||Number
115467|NCT00688064|Secondary|Success Rate on the Investigator's Global Assessment|"Percentage of subjects graded Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12"|Week 12|ITT, LOCF||% of subjects|||Number
115468|NCT00688064|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12||Week 12|ITT, LOCF||% of change||Full Range|Median
115469|NCT00688064|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.||Week 12|ITT, LOCF||% of change||Full Range|Median
115470|NCT00688064|Primary|Percent Change From Baseline in Total Lesion Counts at Week 12.||Week 12|ITT, LOCF||% of change||Full Range|Median
115471|NCT00687973|Secondary|Change From Baseline of Pulse Pressure at Week 24 (Office BP)||Baseline and Week 24|ITT Population||mmHg||Standard Deviation|Least Squares Mean
115472|NCT00687973|Secondary|Change From Baseline of SBP/DBP at Week 24 (Office BP)||Baseline and Week 24|ITT Population||mmHg||Standard Error|Least Squares Mean
115473|NCT00687973|Secondary|Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)||Baseline and Week 24|ITT Population||mmHg||Standard Error|Least Squares Mean
115474|NCT00687973|Secondary|Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)|Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.|Baseline and Week 24|ITT population||mmHg||Standard Error|Least Squares Mean
115475|NCT00687973|Secondary|Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||m/s||Standard Error|Least Squares Mean
115476|NCT00687973|Secondary|Change From Baseline of Aix Corrected to Heart Rate at Week 24|The heart rate correction was computed by a multivariate model analysis|Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||Ratio||Standard Error|Least Squares Mean
115477|NCT00687973|Secondary|Change From Baseline of Aix at Week 24||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||Ratio||Standard Error|Least Squares Mean
115481|NCT00687973|Primary|Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)||Baseline and Week 24|Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)||mmHg||Standard Error|Least Squares Mean
115483|NCT00687908|Secondary|Investigator Global Assessment (IGA) Maintenance Success at Week 24|"IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade.~IGA grade:~0 Clear:Residual hyperpigmentation & erythema may be present~Almost Clear:A few scattered comedones & a few small papules.~Mild:Some comedones & some papules and pustules. No nodules present~Moderate:Many comedones, papules & pustules. One nodule may be present~Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present~Very severe:Highly inflammatory acne covering the face; with nodules & cysts present"|Baseline, Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)||percent of subjects|||Number
115484|NCT00687908|Secondary|Maintenance Success for Non-inflammatory Lesions at Week 24|Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)||percent of subjects|||Number
115485|NCT00687908|Secondary|Maintenance Success for Inflamatory Lesions at Week 24|Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts.|Week 24|ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success)||percent of subjects|||Number
115486|NCT00687908|Primary|Maintenance Success for Total Lesions at Week 24|Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.|Week 24|ITT - Worst-case (Any missing data at Week 24 is considered as a failure)||percent of subjects|||Number
115487|NCT00687856|Secondary|Refine and Test Feedback Control Algorithm That Allows Precise Prescription of Cardiac Loading Through Synchronized and Asynchronized LVAD Operation With Native Left Ventricular Contraction||Measured at Year 3||||||
115488|NCT00687856|Primary|Noninvasive Determination of Left Ventricular Function Using Novel Echocardiographic Imaging Methods and Routine Clinical Assessments to Optimize Markers of Left Ventricular Recovery|LV recovery and LVAD explant|Measured at Year 3|||participants|||Number
115489|NCT00687830|Secondary|Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.|Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.|An hour before the colonoscopy procedure|||participants|||Number
115490|NCT00687830|Primary|Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.||Within 1 hr after the colonoscopy procedure|||units on a scale||Standard Deviation|Mean
115491|NCT00687804|Secondary|Extension Study: Mean Change From Core Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Core baseline (Day 1 of the core study), Month 36 (end of extension study)|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Letters||Standard Deviation|Mean
115492|NCT00687804|Secondary|Extension Study: Mean Change From Extension Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.|Extension baseline (Month12 -end of core study), Month 36 (end of extension study)|Participants from the Safety Population that included all participants who entered the extension and who had at least one safety assessment in the extension study with data available for analyses. Participants were grouped according to the treatment assigned in the Core study.||Letters||Standard Deviation|Mean
115493|NCT00687804|Primary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
115494|NCT00687804|Secondary|Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 36 Months of the Core and Extension Studies|"Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about Adverse Events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
115495|NCT00687804|Secondary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 36 Months of the Core and Extension Studies|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
115496|NCT00687804|Primary|Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study|"Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.~Additional information about adverse events can be found in the Adverse Event section."|Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]|Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.||Percentage of participants|||Number
115497|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Patient-reported Visual Functioning|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient’s subjective assessment of vision-related quality of life. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including the number of patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.||Units on a scale||Standard Deviation|Mean
115498|NCT00687804|Secondary|Core Study: Mean Change From Baseline at Month 12 in Central Retinal Thickness of the Study Eye|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation.|Baseline to Month 12|The number analyzed is the Full Analysis Set, including patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.||Micrometers||Standard Deviation|Mean
115499|NCT00687804|Secondary|Core Study: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set, utilizing last observation carried forward.||Letters||Standard Error|Mean
115500|NCT00687804|Secondary|Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline to Month 12|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.||Participants|||Number
115501|NCT00687804|Primary|Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline through the end of study (Month 12)|Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.||Letters||Standard Deviation|Mean
115502|NCT00687713|Secondary|Overall Reduction of Use (Sustained Abstinence)||21 days||||||
115503|NCT00687713|Primary|Abstinence||Weeks 11 and 12|||participants|||Number
115504|NCT00687674|Secondary|Change in VEGF Expression Levels and Correlation With Clinical Outcomes (Phase II)||Post treatment||||||
115505|NCT00687674|Secondary|Percentage of Stained Circulating Endothelial Cells and Endothelial Progenitor Cells and Correlation With Clinical Outcomes (Phase II||Post treatment||||||
115506|NCT00687674|Secondary|Plasma Cell Gene Expression Profiles and Correlation With > Clinical Outcomes||Post treatment||||||
115507|NCT00687674|Secondary|Change in Apoptosis Rate From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)||||||
115508|NCT00687674|Secondary|Changes in Microvessel Density From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)||Pre and Post treatment (up to 3 years)||||||
123899|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
115509|NCT00687674|Secondary|Time to Disease Progression (Phase II)|"Time to disease progression (TTP) was defined as the time from registration to progression. The median TTP with 95%CI was estimated using the Kaplan Meier method.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|From registration to progression (up to 3 years)|No participants proceeded to Phase II for evaluation.||months||95% Confidence Interval|Median
115510|NCT00687674|Secondary|Overall Survival (Phase II)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 2 years from registration. The median OS with 95%CI was estimated using the Kaplan Meier method|From registration to death (up to 3 years)|No participants proceeded to Phase II for evaluation.||months||95% Confidence Interval|Median
115511|NCT00687674|Primary|Number of Participants Who Achieve a Confirmed Response (Partial Response [PR], Very Good PR [VGPR], Complete Response [CR], or Stringent CR [sCR]) (Phase II)|"Response that was confirmed on 2 consecutive evaluations during treatment~CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)~sCR: CR plus normal FLC ratio & absence of clonal cells in BM~VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration on Treatment (up to 3 years)|No participants proceeded to Phase II for evaluation.||Participants|||Number
115512|NCT00687674|Primary|Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|up to 3 years|One participant refused further treatment prior to being assessed for adverse events.||participants|||Number
115513|NCT00687609|Secondary|C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4|Participants rate most common and most severe ideation type by frequency (1=<once per week/5=many times/day), duration (1=fleeting/5=>8 times per hour persistent, continuous), controllability (1=easily able to control thoughts/8=no attempt), deterrents to active attempts (1=deterrent definitely stopped you/8=N/A, wish to die only), and reason for ideation (1=completely for attention/revenge/reaction/5=completely to stop the pain). Only items with yes responses at a given week are listed. A participant could have a yes response in more than one item.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Participants|||Number
115514|NCT00687609|Secondary|C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts|Solicits suicide-related information with structured questioning. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses at a given week are listed.|Week 4|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Participants|||Number
115515|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task|For the Time Reproduction Task participants need to reproduce the duration of a visual stimulus (lightbulb) by pressing a button. The intervals vary between 2 – 20 seconds. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Milliseconds||Standard Deviation|Mean
115516|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task|For the Contingency Task participants estimate the duration of a time interval of 1 second by pushing a button. Responses that are within a dynamic time interval are being classified as correct. This way, 50 % of the responses are correct, 50% incorrect. Three contingency conditions: neutral, reward and response cost. The performance of this task takes about 15 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Milliseconds||Standard Deviation|Mean
115517|NCT00687609|Secondary|Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task|Consists of 2 types of trials: go trials and stop trials. Go trials require participants to locate the position of an aircraft displayed to the left or right of a fixation point on a computer screen by pressing a left or right button. In 25% of the go stimili an additional stop stimulus (auditory signal) is presented shortly after the go stimulus. Participant then needs to inhibit their response. By varying the time period between go and stop stimulus, 50% of the trials are inhibited successfully, 50% not. The latency of inhibition is estimated. This task takes about 25 minutes.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Milliseconds||Standard Deviation|Mean
115518|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)|The MCQ is a 12-item self-rated questionnaire to assess cannabis craving with 4 factors: compulsivity (an inability to control marijuana use), emotionality (use of marijuana in anticipation of relief from withdrawal/negative mood), expectancy (anticipation of positive outcomes from smoking marijuana) and purposefulness (intention and planning to use marijuana for positive outcomes). Scores are calculated on a 7-point scale (1=strongly disagree; 7=strongly agree). A separate score is calculated for each factor; scores range from 3-21 each with higher scores indicating greater craving.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
115519|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
115520|NCT00687609|Secondary|Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
115521|NCT00687609|Secondary|Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version|The Global Impression of Perceived Difficulties (GIPD) scale is a five-item rating of ADHD-related difficulties. For each item, difficulties during the past week are rated on a 7 point scale (1=normal, not difficult at all; 7= extremely difficult). The GIPD total score is the sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. The scale is completed by the participant.|Baseline, 12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
115522|NCT00687609|Secondary|Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
115523|NCT00687609|Primary|Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher scores indicate greater impairment. The scale is scored by an investigator while interviewing the parent.|12 weeks|It was planned to use the full analysis set (FAS) for the efficacy and safety analyses, which included data from all participants who received at least one dose of atomoxetine and had at least one post-baseline assessment.||Units on a scale||Standard Deviation|Mean
115524|NCT00687544|Secondary|Number of Participants Experiencing Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.|Throughout the study (up to 72 weeks)|||participants|||Number
115525|NCT00687544|Secondary|Number of Participants Who Died||Throughout the study (up to 72 weeks)|||participants|||Number
115526|NCT00687544|Primary|Number of Participants Who Achieved Sustained Biochemical Response (SBR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72).~The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)||||||
115527|NCT00687544|Secondary|Number of Participants Experiencing Opportunistic Infection|The study was terminated due to low enrollment. This analysis was not performed.|Throughout the study (up to 72 weeks)||||||
115528|NCT00687544|Primary|Number of Participants Who Achieved Virologic Response (VR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~The study was terminated due to low enrollment. This analysis was not performed."|24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)||||||
115529|NCT00687544|Primary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|"Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.~SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72).~The study was terminated due to low enrollment. This analysis was not performed."|Week 48 or Week 72 (depending on duration of treatment)||||||
115530|NCT00687531|Secondary|Number of Participants With Use of Rescue Medication in Each Episode||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||Participants||
115531|NCT00687531|Secondary|Number of Participants Who Adhered to Treatment|The compliance was measured via medication consumption. In the end of the last week of study (Week 12), a review of the remaining study drug in the initial prescribed Twisthaler device was done. A Twisthaler reading of 0 indicates no study drug left and full compliance.|Day 1 to Week 12|study completers (per protocol population)||participants|||Number
115532|NCT00687531|Secondary|Number of Participants With One or More Mild, Moderate or Severe Asthma Exacerbations|Exacerbation severity will be characterized based on exacerbation classification from the Global Initiative for Asthma (GINA) workshop 2005 and the National Heart Lung and Blood Institute (NHLBI) asthma guidelines.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
116615|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14||Days 0-14|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
115533|NCT00687531|Secondary|Patient’s Assessment of Response to Therapy Based on a 5-point Scale|A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.|||||
115534|NCT00687531|Secondary|Investigator’s Assessment of Response to Therapy Based on a 5-point Scale|The investigator will assess the subject's response to therapy by interviewing the subject and comparing the current level of symptoms from baseline. A scale of 1 to 5 will be used with 1 being much improved (AM and PM symptom severety/frequency improve >75% from baseline) and 5 being much worse (AM and PM symptom severity/frequency got more than 75% worse from baseline).|Baseline, Week 12|This analysis was not performed due to missing data at the sites.|||||
115535|NCT00687531|Secondary|Number of Puffs of Salbutamol Used Daily||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
115536|NCT00687531|Secondary|Number of Nocturnal Awakenings||Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
115537|NCT00687531|Secondary|Morning and Evening Asthma Symptoms Based on a 3 Point Scale (4 Individual Symptoms) and 24 Points (Summed).|The symptoms of cough, chest tightness, wheezing, and shortness of breath were each to be graded on a scale of 0 to 3 with 0 being no symptoms present and 3 being very marked symptoms which was disturbing most of the time. Scores were to have been recorded at 12AM and 12PM for a total of 24 points summed.|Day 1 and Week 12|This analysis was not performed due to missing data at the sites.|||||
115538|NCT00687531|Secondary|Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint|"Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...~The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question."|Day 1 and Week 12|study completers (per protocol population)||questions|Participants||Number
115539|NCT00687531|Secondary|Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)|Participants were to record their daily AM and PM PEFR values in a diary. PEFR can be measured using a peak flow meter that was given to the participant. Normal readings are based on a person's gender, age, and height. A reading of 80 to 100% of the usual or normal peak flow readings indicate that the asthma is under good control. Increased PEFR indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)||Liters/minute||Standard Deviation|Mean
115540|NCT00687531|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed to measure FEV1, which is the amount of air the participant is able to exhale in 1 second. Normal values for FEV1 in healthy people depend on age and gender, but values between 80% and 120% of the normal value is considered good. Increased FEV1 indicates improvement in asthma control.|Day 1 and Week 12|study completers (per protocol population)||Liters||Standard Deviation|Mean
115541|NCT00687453|Secondary|Any Adverse Event Other Than Hypoglycemia||6 months||||||
115542|NCT00687453|Secondary|Total Daily Insulin Dose||6 months||||||
115543|NCT00687453|Secondary|Body Mass Index Change From Baseline||6 months||||||
115544|NCT00687453|Secondary|Frequency of Severe Hypoglycemic Reactions||6 months||||||
115545|NCT00687453|Secondary|Frequency of Total Hypoglycemic Reactions||6 months||||||
115546|NCT00687453|Secondary|Frequency of Pre-supper Glucose Readings 120 mg/dL or Less||6 months||||||
115547|NCT00687453|Primary|Hemoglobin A1c Change From Baseline||Baseline to 6 months|ITT (LOCF)||Percent||Standard Deviation|Mean
115548|NCT00687440|Primary|Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.|Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.|Intent-to-treat population||Participants|||Number
115549|NCT00687401|Primary|Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score|"PASI 75 response is defined as participants who achieved at least a~75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks|"Intent to Treat Population (ITT): 159 participants out of the 215 enrolled patients who received at least one dose of the study drug.~Per Protocol Population (PP): 138 participants not withdrawn from the study due to major protocol violation and who have received the three infusions of the study drug planned by the protocol."||Participants|||Number
115550|NCT00687362|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 10|"PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10.~The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."|10 weeks|||participants|||Number
115551|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by Functional Assessment of Cancer Therapy (FACT)-G|The FACT-G was a 27-item questionnaire developed to assess the QoL in patients with chronic illnesses. Scores ranged from 0 to 28. For physical well being, lower scores indicated a better outcome. For functional well being, higher scores indicated a better outcome. For social & emotional well being, whether a high score or a lower one indicated a better outcome depended on the question.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.|||||
115552|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by EORTC QLQ-LC13|The EORTC QLQ-LC13 was a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It had a score range 0-100 with higher scores representing an increase in symptoms.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.|||||
115553|NCT00687323|Secondary|Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30|The EORTC QLQ-C30 was a 30-item questionnaire developed to assess the QoL of cancer patients. Scores ranged from 0 -100. For functional and global QoL scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.|Baseline and post-study visit (63 weeks)|Analysis could not be performed due to incomplete data.|||||
115554|NCT00687323|Secondary|Progression-free Survival for Participants Achieving PR, MLSF, or MR|Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) who achieved PR, MLSF, or MR||months||95% Confidence Interval|Median
115555|NCT00687323|Secondary|Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity|Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions.|From first dose to 30 days after last dose of study drug (up to 67 weeks)|Number of participants who achieved CR, PR, or MLFS and received modified low dose maintenance therapy||participants|||Number
115556|NCT00687323|Secondary|MGMT Expression in Leukemic Blasts at the Time of Relapse|"Low MGMT expression was defined as MGMT/β-actin ratio of <0.2.~MGMT & β-actin are cancer biomarkers."|Up to 1 year after treatment ends (up to 115 weeks)|Analysis could not be performed due to lack of specimens.|||||
115557|NCT00687323|Secondary|Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression|Low MGMT expression was defined as MGMT/β-actin ratio < 0.2. MGMT & β-actin are cancer biomarkers.|Baseline|All screened participants||participants|||Number
115558|NCT00687323|Secondary|Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|"OS was defined as the time from start of treatment until death or end of study.~Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent."|Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||months||95% Confidence Interval|Median
115559|NCT00687323|Secondary|Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Relapse-free survival was defined as time to disease progression. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.|Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)]|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||months||95% Confidence Interval|Median
115560|NCT00687323|Secondary|Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide|Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.|Up to 1 year after treatment ends (up to 115 weeks)|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||Days||Full Range|Median
115561|NCT00687323|Primary|Clinical Response at the End of Temozolomide Induction|"Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease.~CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent.~Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met.~Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts."|at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks|Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline)||participants|||Number
115562|NCT00687297|Secondary|Progression-free Survival|Time from randomization to first evidence of disease progression or death. Patients alive without progression are censored at the date of last disease evaluation.|every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance)|All randomized patients were included.||months||95% Confidence Interval|Median
115563|NCT00687297|Secondary|Objective Response Rate|Best overall response (complete or partial response), assessed using RECIST criteria (version 1.0)|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.||percentage of participants||95% Confidence Interval|Number
115564|NCT00687297|Primary|Progression-free Survival|Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation.|Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))|All randomized patients were included.||Months||95% Confidence Interval|Median
115565|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at End of Treatment|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Up to 48 weeks|||Participants|||Number
116616|NCT00677820|Secondary|Number of Subjects Reporting Any Adverse Event (AE) Post-treatment||Days 0-7|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
115566|NCT00687219|Secondary|Number of Participants With Undetectable HCV-RNA at Week 24|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Week 24|Peginterferon alfa-2b administered at 1.0 μg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks||Participants|||Number
115567|NCT00687219|Primary|Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)|Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)|Measured at 24 weeks after 48 weeks treatment (72 weeks)|||Participants|||Number
115568|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115569|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115570|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115571|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115572|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115573|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change =score at Week 12 minus score at baseline"|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115574|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115575|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115576|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115577|NCT00687193|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).~Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115578|NCT00687193|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Change = score at Week 12 minus score at baseline."|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115579|NCT00687193|Secondary|Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)|ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.|Baseline, Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
115580|NCT00687193|Secondary|Change From Baseline in C- Reactive Protein (CRP) (mg/L)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||mg/L||Standard Error|Least Squares Mean
115581|NCT00687193|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritis|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115582|NCT00687193|Secondary|Change From Baseline in Patient’s Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115583|NCT00687193|Secondary|Change From Baseline in Patient’s Assessment of Pain|"Change from Baseline in Patient’s Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement.~Change = value at observation minus value at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115584|NCT00687193|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||units on a scale||Standard Error|Least Squares Mean
115585|NCT00687193|Secondary|Change From Baseline in Painful and Tender Joint Counts|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.|Baseline, Weeks 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||units on a scale||Standard Error|Least Squares Mean
115586|NCT00687193|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|"HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.~Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
123900|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||g/dL||Standard Deviation|Mean
115587|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]|"The DAS28-4 (ESR) score is a measure of the participant’s disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant’s global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.~Change = score at observation minus score at baseline."|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115588|NCT00687193|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]|"The DAS28-3 (CRP) score is a measure of the perticipant’s disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity.~Change = value at observation minus value at baseline"|Baseline, Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were not imputed.||Units on a scale||Standard Error|Least Squares Mean
115589|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
115590|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
115591|NCT00687193|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.|Week 2, 4, 8 and 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
115592|NCT00687193|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP)at each visit.|Week 2, 4, and 8|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
115593|NCT00687193|Primary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|The full analysis set included all participants who were randomized to the study and received at least 1 dose of study medication. Missing values were handled using the Last Observation Carried Forward (LOCF) method.||participants|||Number
115594|NCT00687167|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
115595|NCT00687167|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.|||ng/mL||Standard Deviation|Mean
115596|NCT00687076|Secondary|Effect of Intensive Lipid Modification Medication Therapy on Thrombosis, and Relationship to PAD Progression, Restenosis, and Clinical Events||Measured at baseline and Months 6, 12, and 24||||||
115597|NCT00687076|Secondary|Change in Total Cholesterol (mg/dl) From Baseline to Month 12|Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) [mg/dl].|Measured at baseline and 12 months|All values are medians and interquartile range (IQR). P-values were calculated with the KruskaleWallis rank test.||mg/dl||Inter-Quartile Range|Median
116156|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||participants|||Number
115598|NCT00687076|Primary|Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis|"The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed.~Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4)."|Measured at baseline and Months 6, 12, and 24|Multilevel models were used to describe changes over time in the MRI outcome variables and to compare the drug therapy groups. The advantage of multilevel models is the capability to use data with missing or irregularly timed observations, due to death or loss to follow-up, on the outcome variable.||mm^3, at 24-months||Standard Error|Mean
115599|NCT00686998|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline|PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.|Baseline, Day 28|||Points on a scale||Standard Error|Mean
115600|NCT00686959|Secondary|Percentage of Participants With a Post Baseline Swallowing Diary Score >=4|Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.|Baseline through 30 Days Post Study|All randomized participants with at least one post baseline swallowing diary score.||percentage of participants||95% Confidence Interval|Number
115601|NCT00686959|Secondary|First Site of Disease Failure in Terms of Relapse|The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.|Baseline to Relapse (Up to 66.6 Months)|All randomized participants with objective PD.||percentage of participants||95% Confidence Interval|Number
115602|NCT00686959|Secondary|Survival Rates at 1, 2, and 3 Years|The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.||probability of survival||95% Confidence Interval|Number
115603|NCT00686959|Other Pre-specified|Adverse Events: The Number of Deaths Per Treatment Group|The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 30 Days Post Study|All randomized participants who received at least one dose of study drug.||participants|||Number
115604|NCT00686959|Secondary|Objective Response Rate (Complete Response [CR] + Partial Response [PR])|Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline to Measured Progressive Disease (Up to 7 Months)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
115605|NCT00686959|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)|All randomized participants. Arm A had 99 participants censored and Arm B had 87 participants censored.||months||95% Confidence Interval|Median
115606|NCT00686959|Primary|Overall Survival|Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.|Baseline to Date of Death from Any Cause (Up to 71.4 Months)|All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.||months||95% Confidence Interval|Median
116617|NCT00677820|Secondary|Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7||Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
115607|NCT00686894|Primary|The Number of Enthesitis Between Week 4 and Week 12 Evaluated Using Power Doppler Ultrasonography (PDUS) and Proprietary Software.|Two measures were to be used for each enthesis evaluation. 1.) Vascularization: yes/no. 2.) Area of hyper-vascularization: mm^2 (continuous) using proprietary software. This study was terminated early due to slow recruitment. As a result, efficacy analyses were not performed.|8 weeks|||Number of Enthesitis|||Number
115608|NCT00686881|Secondary|Number of Participants With Change in Metavir Inflammation Score|Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).|Baseline and Week 48|All treated participants excluding 3 participants on the PegIFN-2b arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.||Participants|||Number
115609|NCT00686881|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration|The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.|Week 24|All treated participants except 1 SNMC participant who had no available data after initial treatment.||Participants|||Number
115610|NCT00686881|Primary|Number of Participants With Change in Metavir Fibrosis Score|Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).|Baseline and discontinuation of treatment (up to 156 weeks)|All treated participants excluding 2 participants on the PegIFN-2B arm and 1 participant on the SNMC arm for whom baseline data were non-evaluable or for whom no post-baseline data were available.||Participants|||Number
115611|NCT00686855|Primary|The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.|Participants were given a survey at the time of screening and 4 weeks after start of therapy. The participants self-reported three symptoms of oral cGVHD: oral sensitivity, mouth pain, and mouth dryness. Each symptom was given a score ranging from 0-10, with 0 as none and 10 as the worst. Improvement in subjective scores was defined as 3 points or further reduction from pre-treatment to post-treatment assessment.|Participants were assessed at Baseline and 4 weeks after start of therapy|Of the 46 participants enrolled on the trial, 36 were deemed evaluable for response.||participants|||Number
115612|NCT00686842|Secondary|Effects of Study Drug on Viral Gene Expression and Cellular Gene Transcription, as Measured by Real-time Quantitative PCR-based Profiling, in Tumor Biopsy Samples||Screening and day 28||||||
115613|NCT00686842|Secondary|Effects of Study Drug on VEGF, VEGFR-2 and -3, Phospho-Akt, p53, and HIF-1α Expression and Tumor Cell Proliferation, as Measured by Ki-67 Staining, in Tumor Biopsy Samples||Screening and day 28||||||
115614|NCT00686842|Secondary|Effects of Study Drug on T-lymphocyte Subsets (i.e., CD4 and CD8)||Screening, day 29, every 3 cycles thereafter, and at treatment discontinuation||||||
115615|NCT00686842|Secondary|Effects of Study Drug on HIV and KSHV Viral Loads||Screening, end of cycle 1, end of every third cycle thereafter, and treatment discontinuation||||||
115616|NCT00686842|Secondary|Effects of Study Drug on Serum and Plasma VEGF, VEGFR, and Cytokine Profiles||On the first day of every 28-day cycle of treatment, Day 15, and treatment discontinuation||||||
115617|NCT00686842|Secondary|Pharmacokinetics||Days 1, 15, 28, 57||||||
115618|NCT00686842|Primary|Response to Treatment||After each 28-day cycle of treatment and at discontinuation of therapy||||||
115619|NCT00686842|Primary|Maximum Tolerated Dose||After each group of 3 subjects completes cycle 1 of treatment||||||
115620|NCT00686842|Primary|Safety and Toxicity of Anti-VEGF Small Molecule PTC299|Patients who experienced an adverse event of grade 3 or greater|All study visits|||participants|||Number
115621|NCT00686803|Primary|Pharmacodynamics as Measured by cGMP Levels.|"Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax~The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible."|24 hours|||ng/mL||Full Range|Median
115622|NCT00686803|Primary|Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.|"The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach.~•Maximum concentration (Cmax)~The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible."|24 hours|||ng/mL||Standard Deviation|Mean
115623|NCT00686790|Secondary|Number of Participants With a Liver Histology Response|"The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies.~The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT."|Baseline and 52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.||Participants|||Number
115624|NCT00686790|Primary|Number of Participants With a Combined Response|"The combined response was defined as an ALT level below the upper~reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L."|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis."||Participants|||Number
115625|NCT00686790|Primary|Number of Participants With a Biochemical Response|A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.|52 weeks (EOT), 104 weeks (EOF)|"The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available.~2 participants with adverse events (AE) that had protocol violations have been included in the analysis."||Participants|||Number
115626|NCT00686790|Secondary|Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)|Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.|52 week (EOT)|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.||Participants|||Number
115627|NCT00686790|Primary|Number of Participants With a Virological Response|For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).|52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation|The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.||Participants|||Number
115628|NCT00686777|Primary|Number of Participants Discontinuing Treatment|Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.|From time of first treatment to Week 48|||participants|||Number
115629|NCT00686777|Secondary|Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT|HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.|Measured at 24 weeks of treatment and at EOT (Treatment week 48)|All treated Participants||percentage of participants|||Number
115630|NCT00686777|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation|"SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.~HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result."|Measured at 24 weeks after the end of treatment (at the end of follow-up)|All treated Participants||percentage of participants|||Number
115631|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group|"MGMT was measured by IHC.~PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 8."||months||Standard Deviation|Median
115632|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group|"MGMT was measured by IHC.~PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 9."||months||Standard Deviation|Median
115633|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group|"MGMT was measured by IHC.~OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.~OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 6."||percentage of participants||95% Confidence Interval|Number
115634|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group|"MGMT was measured by IHC.~OS rate was defined as the percentage of participants who were still alive 6, 12, & 18 months after starting study treatment.~OS was calculated by the Kaplan-Meier method."|6, 12, & 18 months|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 7."||percentage of participants||95% Confidence Interval|Number
115635|NCT00686725|Secondary|Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group|"MGMT was measured by IHC.~OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.~OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-negative participants are included in this outcome measure. MGMT-positive participants are reported in outcome measure 4."||months||Standard Deviation|Median
115636|NCT00686725|Secondary|Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group|"MGMT was measured by immunohistochemistry (IHC).~OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive.~OS was calculated by the Kaplan-Meier method."|Up to 2 years|"Participants with enough tissue to perform MGMT analysis.~Only MGMT-positive participants are included in this outcome measure. MGMT-negative participants are reported in outcome measure 5."||months||Standard Deviation|Median
115637|NCT00686725|Secondary|Objective Tumor Assessment After Surgery: Overall Response|"Overall response was based on neuroimaging (magnetic resonance imaging [MRI]), clinical neurological examination, and steroid administration.~It was assessed as follows:~Complete Response (CR): Disappearance of all enhancing tumor (measurable~or non-measurable), no corticosteroid use, and neurologically stable or~improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor~(measurable or non-measurable) for any measurable lesions or definite~improvement for any non-measurable lesions, corticosteroid dosage stable or~reduced, and neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in contrast enhancement for any~measurable lesions or definite worsening for any non-measurable lesions, or~any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded.~Stable Disease (SD): All other situations."|Up to 2 years|||participants|||Number
115638|NCT00686725|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death.~PFS was calculated by the Kaplan-Meier method."|Up to 2 years|||months||95% Confidence Interval|Median
115639|NCT00686725|Primary|Overall Survival (OS)|"OS was defined as the time from randomization to death.~OS was calculated by the Kaplan-Meier method."|Up to 2 years|||months||95% Confidence Interval|Median
115647|NCT00686699|Secondary|Mean ESRS Part IV Subscores: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
115648|NCT00686699|Secondary|Lowest ESRS Part IV Subscore: Dyskinesia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
115649|NCT00686699|Secondary|Mean ESRS Part III Subscores: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
115650|NCT00686699|Secondary|Lowest ESRS Part III Subscore: Dystonia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
115651|NCT00686699|Secondary|Mean ESRS Part II Subscores: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
115652|NCT00686699|Secondary|Lowest ESRS Part II Subscore: Parkinsonism and Akathisia Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
115653|NCT00686699|Secondary|Mean ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The mean subscores at Hours 1, 2, 3, 4, 5 and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
115654|NCT00686699|Secondary|Lowest ESRS Part I Subscore: EPS and DIMD Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). A lower subscale score reflects a better outcome. The lowest subscale score on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
115655|NCT00686699|Secondary|Mean ESRS Total Scores Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of EPS and DIMD over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The mean ESRS total scores at Hours 1, 2, 3, 4, 5, and 6 on Day 14 were analyzed.|1, 2, 3, 4, 5, and 6 hours post-dose on Day 14|Consisted of all participants who had a Baseline value and at least one post-Baseline value at each time point for Day 14 ESRS scores from both treatment periods. Therefore Baseline includes only participants who had corresponding data on Day 14.||Score on a scale||Standard Deviation|Mean
115656|NCT00686699|Primary|Lowest Extrapyramidal Symptom Rating Score (ESRS) Total Score Within the 6-hour Evaluation on Day 14 of Each Treatment Period|The ESRS total score consists of 4 subscales: 1) a questionnaire of extrapyramidal symptoms (EPS) and drug-induced movement disorders (DIMD) over the previous 7 days (7 items scored as 0=Absent to 3=Severe; score range: 0-21), 2) an examination of Parkinsonism and akathisia (17 items scored as 0=None to 6=Severe; score range: 0-102), 3) an examination of dystonia (10 items scored as 0=Absent to 6=Most Severe; score range 0-60) and 4) an examination of dyskinesia (7 items scored as 0=None to 6=Severe; score range: 0-42). The ESRS total score could range from 0 to 225, with a lower score reflecting a better outcome. The lowest ESRS total score for each participant within the 6-hour range on Day 14 was analyzed.|Up to 6 hours post-dose on Day 14|Consisted of all participants who received both treatments & had Day 14 ESRS scores from both treatment periods.||Score on a scale||Standard Deviation|Mean
115657|NCT00686686|Secondary|Dermatology Life Quality Index (DLQI)|"The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a subject's QOL. It is a 10-item questionnaire that can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI was completed by the subject prior to the PPPASI and PGA evaluations.~The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired."|Baseline and Week 12|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16.||scores on a scale||Standard Deviation|Mean
115658|NCT00686686|Secondary|Number of Participants Who Respond to the Fourth Infusion.|>=25% reduction in PPPASI score would be considered a response.|Week 12 and Week 18|Only three participants received a fourth infusion but according to the protocol they were not suppose to receive it at that time because their improvement in PPPASI score on Week 8 was less than 75%. Therefore, because no participants qualified to be analyzed for this endpoint, no data are given.|||||
115659|NCT00686686|Secondary|Number of Participants Achieving Clear to Minimal PGA Score at Weeks 12 and 18.|"The Physician Static Global Assessment (PGA) documents the physician's assessment of the subject's psoriasis status according to the following categories: induration, scaling, and erythema. Each category is rated from 0 to 5, where 0 represents no evidence of induration/scaling/erythema (clear), 1 represents minimal induration/scaling/erythema, and 5 represents the most severe induration/scaling/erythema."|Weeks 12 and 18|One of the 17 participants in the Per Protocol population did not perform the week 12 visit, therefore n=16 for the Week 12 observations (but n=17 for the Week 18 observations).||participants|||Number
115660|NCT00686686|Secondary|Number of Participants Who Achieve a Moderate Response.|Moderate response is defined as a 50% to 75% reduction in PPPASI score from baseline.|Baseline and Week 8|It was decided that this analysis will not be done.|||||
115661|NCT00686686|Primary|Number of Participants Who Achieve at Least 75% Improvement in Palmoplantar Psoriasis Activity Severity Index (PPPASI) After 3 Infusions.|"The PPPASI score is an overall score of disease signs: extent, scales, erythema, erosions (fissures), induration and pustules. Extent is rated on a scale range from 0-6; all other signs are rated on a scale range from 0 to 4 in a target palm and/or sole. Total score range:0-26. A reduction in score is considered an improvement."|Baseline and Week 8|Per Protocol population included the 17 subjects who completed the trial.||participants|||Number
115662|NCT00686647|Secondary|Major Adverse Cardiac Events|cardiac death, myocardial infarction, or target lesion revascularization|9 months|||percentage of participants|||Number
115663|NCT00686647|Secondary|Major Adverse Cardiovascular Events|cardiac death, myocardial infarction, or target lesion revascularization|30 days|intention to treat||percentage of particpants|||Number
115664|NCT00686647|Primary|Procedural Success|Defined as less than or equal to 30% diameter stenosis in the main branch and less than or equal to 70% diameter stenosis in the side branch at the conclusion of the procedure (including adjunctive stenting) in the absence of in-hospital major adverse cardiac events (MACE) [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR]|1 day|intention to treat||percentage of participants|||Number
115665|NCT00686634|Secondary|Number of Adverse Events||1 year|||Adverse event|||Number
115666|NCT00686634|Secondary|Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year||1 year|||participants|||Number
115667|NCT00686634|Secondary|Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months||4 months|||participants|||Number
115668|NCT00686634|Primary|Hemoglobin A1c (HbA1c) Change From Baseline||Baseline, 4 months|Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months)||percentage||Standard Deviation|Mean
115669|NCT00686595|Secondary|Percent Reduction in SKINDEX-29 Scores at Week 24|The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the SKINDEX-29 assessments were available.||Percent reduction||Standard Deviation|Mean
115939|NCT00684060|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.)|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV mass from baseline to six months."||g||Standard Deviation|Mean
115670|NCT00686595|Secondary|Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18|The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from “never” (=0) to “all the time” (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the SKINDEX-29 assessments were available.||Percent reduction||Standard Deviation|Mean
115671|NCT00686595|Secondary|Percent Reduction in DLQI Total Score at Week 24|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the DLQI assessment was available.||Percent reduction||Standard Deviation|Mean
115672|NCT00686595|Secondary|Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18|DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the DLQI assessment was available.||Percent reduction||Standard Deviation|Mean
115673|NCT00686595|Secondary|Percent Reduction in VAS Referred Itch at Week 24|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the VAS assessment was available.||Percent reduction||Standard Deviation|Mean
115674|NCT00686595|Secondary|Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18|VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the VAS assessment was available.||Percent reduction||Standard Deviation|Mean
115675|NCT00686595|Secondary|Percent Reduction in Affected BSA at Week 24|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the BSA assessment was available.||Percent reduction||Standard Deviation|Mean
115676|NCT00686595|Secondary|Percent Reduction in Affected Body Surface Area (BSA) at Week 18|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant’s body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the BSA assessment was available.||Percent reduction||Standard Deviation|Mean
115677|NCT00686595|Secondary|Percent Reduction in SAPASI at Week 24|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 24 compared to baseline is reported.|Baseline and Week 24|Participants from the ITT population for whom the SAPASI assessment was available.||Percent reduction||Standard Deviation|Mean
115678|NCT00686595|Secondary|Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18|SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 18 compared to baseline is reported.|Baseline and Week 18|Participants from the ITT population for whom the SAPASI assessment was available.||Percent reduction||Standard Deviation|Mean
115679|NCT00686595|Secondary|PASI 100 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 24 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 24.|24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115680|NCT00686595|Secondary|PASI 100 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 18 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115681|NCT00686595|Secondary|PASI 100 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115682|NCT00686595|Secondary|PASI 90 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 24 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 24.in PASI at Week 24|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115683|NCT00686595|Secondary|PASI 90 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 18 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115684|NCT00686595|Secondary|PASI 90 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 10 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115685|NCT00686595|Secondary|PASI 50 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 24 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115686|NCT00686595|Secondary|PASI 50 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 18 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115687|NCT00686595|Secondary|PASI 50 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 10 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115688|NCT00686595|Secondary|PASI 75 Response Rate at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 24 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 24.|Baseline and 24 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percentage of participants|||Number
115689|NCT00686595|Secondary|PASI 75 Response Rate at Week 18|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 18 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 18.|Baseline and 18 weeks|Participants from the ITT population for whom the PASI assessment was available.||Percent of participants|||Number
115690|NCT00686595|Primary|Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.|Baseline and 10 weeks|Participants from the intent-to-treat (ITT) population for whom the PASI assessment was available.||Percentage of participants|||Number
117159|NCT00672555|Secondary|Body Image Score|Patients was sent a postal questionnaire at 1 year, assessing body image with the body image questionnaire adapted from Dunker et al. Body image score resulting form 5 questions: worst 5; best 20.|1 year|||Units on a scale||Standard Deviation|Mean
115691|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
115692|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15|Individual mean concentrations calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
115693|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
115694|NCT00686543|Primary|Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 3 and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||Participants|||Number
115695|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 8 and 15|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||ng/mL||90% Confidence Interval|Mean
115696|NCT00686543|Primary|Mean POS Plasma Concentrations on Days 2, 3, and 8.|Individual mean concentrations were calculated as the average of observed concentrations at 0 hour (before the morning dose) and 5 hours after the morning dose.|Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8|Analysis of the primary outcome was done on the Balanced Data Set, defined as all participants with no missing pharmacokinetic data for Days 3, 8, and 15 (n=49). From Days 1 to 8, these 49 participants received 200 mg TID. From Days 9 to 15, these 49 participants were randomized to either 200 mg TID (n=19), 400 mg BID (n=14), or 400 mg TID (n=16).||ng/mL||90% Confidence Interval|Mean
115697|NCT00686517|Secondary|Number of Peripheral Blood Mononuclear Cells (PBMCs)|Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.|Treatment Weeks 2, 4, 8, and 12|The association between HCV specific immune and SR to be assessed applying descriptive methods could not be evaluated as PBMC measurements were not carried out.|||||
115698|NCT00686517|Secondary|Number of Participants With Rapid Virologic Response (RVR)|"Participants were considered to have RVR if serum HCV RNA level at 2 or 4~weeks of treatment was below the cut off value of the referring local~laboratory of each participating site."|Evaluated at 2 and 4 weeks of treatment|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
115699|NCT00686517|Secondary|Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization|ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.|Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
115700|NCT00686517|Secondary|Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).|LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.|At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
115701|NCT00686517|Secondary|Virologic Response at the End of Treatment Follow-up (ETR)|"ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks~treatment (depending on treatment arm) was <15 IU/mL."|At the end of treatment (either 12 weeks or 24 weeks depending on randomization).|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
117160|NCT00672555|Secondary|Patient Overall Satisfaction With Procedure|Follow-up was initiated at 1 year. A postal questionnaire was sent to the patients with a VAS assessing overall satisfaction. Possible values were: lowest: 0; highest 10.|1 year|||Units on a scale||Standard Deviation|Mean
115702|NCT00686517|Primary|Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period|SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.|Evaluated at the end of 6 months|Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.||participants|||Number
115703|NCT00686335|Primary|Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment|Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.|4 weeks and 8 weeks|The efficacy analysis population included all 7 patients who completed both study periods without major protocol deviations.||number of nocturnal awakenings||Standard Deviation|Mean
115704|NCT00686257|Secondary|In-hospital Mortality Rate||during hospitalization (after recruitment)||||||
115705|NCT00686257|Secondary|Length of Hospital Stay||during hospitalization (after recruitment)||||||
115706|NCT00686257|Secondary|Dyspnea||During the first 3 hours of recruitment||||||
115707|NCT00686257|Secondary|Total Length of Time Requiring NPPV||during hospitalization (after recruitment)||||||
115708|NCT00686257|Secondary|Changes in Gas Exchange||during the first 24 hours of the study||||||
115709|NCT00686257|Secondary|Changes in Vital Signs|At initiation;30 minutes, 1 hour, 3 hours and 24 hours after NPPV initiation|during the first 24 hours of the study||||||
115710|NCT00686257|Secondary|Early NPPV Discontinuation Rate|defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support|During hospitalization period (after recruitment into the study)||||||
115711|NCT00686257|Primary|Time Required for Mask Placement||at the initiation of NPPV||||||
115712|NCT00686257|Primary|Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)||During the first 3 hours of recruitment|By power analysis||units on a scale||Standard Error|Mean
115713|NCT00686231|Secondary|To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization.|Radial artery diameter|November 2009||11/2009||||
115714|NCT00686231|Primary|To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery.|Diameter of radial artery|November 2009|||mm||Standard Deviation|Mean
115715|NCT00686205|Primary|PRISM HIV O Plus Test Data for Sensitivity|Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).|12 months|1,388 specimens from individuals positive for HIV antibodies and 136 specimens positive by supplemental testing from US individuals at increased risk of HIV infection or from an HIV-2 endemic area. These 1,524 specimens were used for the sensitivity calculation.||participants|||Number
115716|NCT00686205|Primary|PRISM HIV O Plus Test Data for Specificity|Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.|12 months|The analysis was per the protocol.||participants|||Number
115717|NCT00686166|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.|Only adverse events that are possibly, probably or definitely related to study regimen are reported.|Up to 4 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.||Participants|||Number
115718|NCT00686166|Secondary|3-year Disease-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|3 years|Eligible and analyzable patients||percentage of participants||95% Confidence Interval|Number
115719|NCT00686166|Primary|Pathologic Complete Response Rate|Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.|15-20 weeks from registration|Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.||percentage of participants||95% Confidence Interval|Number
115720|NCT00686127|Secondary|Pain Interference With Function||12 weeks||||||
115721|NCT00686127|Primary|Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks|Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).|Baseline, 12 weeks|This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.||units on a scale|||Number
115722|NCT00686075|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.||participants|||Number
116157|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.|||||
115723|NCT00686075|Secondary|Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization|An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.||participants|||Number
115724|NCT00686075|Secondary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.|Day 0 to Day 365|Safety population included all randomized participants who received study vaccine and had any safety follow-up data.||participants|||Number
115725|NCT00686075|Secondary|Genotypic Stability of Recovered Vaccine-Type Virus|Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.|Within 28 days after any dose|Shedding population included all randomized participants who received study vaccine and had valid shedding data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||nasal wash samples|Participants||Number
115726|NCT00686075|Secondary|Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3|Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.|Day 28 after Dose 3|Immunogenicity population included all randomized participants who received study vaccine for the specified dose and had valid immunogenicity data. 'N' (number of participants analyzed) = participants evaluable for this measure; and ‘n’ = participants evaluable for specified virus type, for each group, respectively.||percentage of participants||95% Confidence Interval|Number
115727|NCT00686075|Secondary|Number of Participants Who Shed Vaccine-Type Virus|Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.|7, 12 and 28 days after Dose 1, 2 and 3|Shedding population included all randomized participants who received study vaccine and had valid shedding data after the specified dose. ‘N’ (number of participants analyzed) = participants who were evaluable for this measure; and 'n' = participants who were evaluable for this measure at given time points for each group, respectively.||participants|||Number
115728|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
115729|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
115730|NCT00686075|Primary|Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1|An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
115731|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
115732|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
123901|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
115733|NCT00686075|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
115734|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
115735|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
115736|NCT00686075|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
115737|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 3|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 3|Dose 3 safety population included all randomized participants who received study vaccine Dose 3 same as previous doses and had safety follow-up data.||participants|||Number
115738|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 2|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 2|Dose 2 safety population included all randomized participants who received study vaccine Dose 2 same as Dose 1 and had safety follow-up data.||participants|||Number
115739|NCT00686075|Primary|Number of Participants With Solicited Symptoms After Dose 1|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.|Within 28 days after Dose 1|Dose 1 safety population included all randomized participants who received study vaccine Dose 1 and had safety follow-up data.||participants|||Number
115740|NCT00686036|Secondary|Serum Testosterone Levels||Change from baseline at each visit post-randomization until until week 78|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
115741|NCT00686036|Secondary|Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)||From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
115742|NCT00686036|Secondary|Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||78 weeks during off-treatment phase of ADT|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
115743|NCT00686036|Primary|Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)||52 weeks|Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.|||||
115744|NCT00685945|Other Pre-specified|Net Glucose Uptake|Individual net reuptake rates at each time point were calculated by the following formula: net uptake = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of glucose in the brachial vein and artery, respectively.|At baseline and after maximum dose of bradykinin|||microgram/min/100ml||Standard Error|Mean
115745|NCT00685945|Secondary|Forearm Blood Flow (FBF)|Forearm blood flow was measured by strain gauge plethysmography|During and after each study drug administration|||ml/min/100ml||Standard Error|Mean
115832|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Two weeks and one month after the challenge dose|Analysis was performed on the Log-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
115746|NCT00685945|Primary|Net Tissue-type Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively.|During and after each study drug administration|Twenty four subjects were studied. One subject was excluded because of erroneous drug administration. Analysis was per protocol. Twenty-three subjects receive bradykinin then L-NMMA plus bradykinin infusions. Subjects were then randomized to either isosorbide or sildenafil. Twelve subjects received sildenafil and 11 subjects received isosorbide.||ng/min/100ml||Standard Error|Mean
115747|NCT00685880|Primary|Number of Participants With a Decreased Pain Score >20%|Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.|baseline, 6 month follow-up||||||
115748|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|Pharmacokinetic analyses of cilostazol and Pletal® are based on 28 and 27 subjects, respectively. Reliable estimates could not be obtained for one subject administered Cilostazol and two subjects administered Pletal® because there was not a smooth decline in concentrations in the terminal phase of elimination.||ng-hr/mL||Standard Deviation|Mean
115749|NCT00685802|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
115750|NCT00685802|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours after drug administration.|||ng/mL||Standard Deviation|Mean
115751|NCT00685763|Secondary|Collect and Analyze Tumor Control Measures||1 year following the completion of radiation therapy||||||
115752|NCT00685763|Primary|Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)||1 year following the completion of radiation therapy|||participants|||Number
115753|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||participants|||Number
115754|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in PP Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||participants|||Number
115755|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|Number at Test of Cure Visit, ITT population||participants|||Number
115756|NCT00685698|Secondary|Need for Surgery, Hospitalisation and Non-Study Antibiotic Therapy for Diabetic Foot Infection During Study (in ITT Population)|Results in relation to the need for surgery, hospitalization, new and/or additional non-study antibiotic therapy for failure of initial oral therapy at End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|Number at the End of Treatment/Early Termination Visit, ITT population||participants|||Number
115757|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||participants|||Number
115758|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in PP Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||participants|||Number
115759|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at Test of Cure in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and Test of Cure.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||participants|||Number
115760|NCT00685698|Secondary|Diabetic Foot Assessment (PEDIS) Shifts From Baseline at End of Treatment/Early Termination in ITT Population|The number of patients within each of the PEDIS grading categories (uninfected, mild, moderate and severe) at baseline and End of Treatment/Early Termination.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||participants|||Number
115761|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||scores on a scale||Standard Deviation|Mean
115762|NCT00685698|Secondary|Total Wound Score (at End of Treatment/ Early Termination in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and End of Treatment/ Early Termination visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||scores on a scale||Standard Deviation|Mean
115763|NCT00685698|Secondary|Total Wound Score (at Test of Cure in PP Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||scores on a scale||Standard Deviation|Mean
115764|NCT00685698|Secondary|Total Wound Score (at Test of Cure in ITT Population)|The Diabetic Foot Infection (DFI) Wound Scores will be used to evaluate the wound assessment at baseline and Test of Cure visits. The wound composite score was based on combining the general wound parameters (signs and symptoms of infection), and wound measurements (length, width, depth). Each wound parameter was assigned a score based on severity, with higher scores defining greater severity. For wound measurements and undermining, larger measurements received higher scores. The minimum and maximum score are 3 and 49, respectively.|Visit 1 (Baseline); Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||scores on a scale||Standard Deviation|Mean
115765|NCT00685698|Secondary|Per-Pathogen Microbiological Responses|Microbiological responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Microbiological Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Microbiological Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||percentage of participants||95% Confidence Interval|Number
115766|NCT00685698|Secondary|Per-Pathogen Clinical Response (at End of Treatment/Early Termination)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at at End of Treatment/Early Termination within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||percentage of participants||95% Confidence Interval|Number
115767|NCT00685698|Secondary|Per-Pathogen Clinical Responses (at Test of Cure)|Clinical responses were assessed on a per-pathogen basis for the most frequently isolated pathogens at baseline (i.e., present in four or more patients), including MRSA. Clinical Responses were assessed at Test of Cure visit within each of the ITT and PP populations. Insufficient numbers prevented reporting Clinical Success rates for Streptococcus pyogenes in the PP population.|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||percentage of participants||95% Confidence Interval|Number
115768|NCT00685698|Secondary|Clinical Success (at End of Treatment/Early Termination)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|End of Treatment/Early Termination Visit; 7±1, 14±1, 21±1 or 28±1 days after Baseline (Day 1)|||percentage of participants||95% Confidence Interval|Number
115769|NCT00685698|Secondary|Clinical Success (in PP Population)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1), and adhered to the protocol without major protocol violations.||percentage of participants||95% Confidence Interval|Number
115770|NCT00685698|Secondary|Microbiological Success Rate|"Microbiological Success~Eradicated, defined as absence of the original pathogen(s) from a repeat culture of the original infection site performed at the TOC visit.~Presumed Eradicated, defined as meeting the definition for Clinical Success at the TOC visit, but tissue sample could be obtained for culture from the original infection site.~TOC=Test of Cure"|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|||percentage of participants||95% Confidence Interval|Number
115771|NCT00685698|Primary|Clinical Success (in ITT Population)|"Clinical Success~Resolution is defined as total resolution of all pretreatment clinically significant signs and symptoms of infection and no development of any systemic evidence of infection.~Improvement is defined as resolution of more than two, but not all, pretreatment clinical signs and symptoms, or partial resolution of all clinical signs and symptoms relative to the baseline assessment, with no further need for antibiotic therapy, and no need for infection-related surgical interventions."|Test of Cure Visit, 12±2 days after End of Treatment Visit/Early Termination|All eligible patients who took at least one whole dose of study drug and had at least 1 gram-positive pathogen identified at the Baseline Visit (Visit 1).||percentage of participants||95% Confidence Interval|Number
115815|NCT00684983|Primary|Progression-free Survival (PFS)|Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.|From randomization to the earliest date of documentation of disease progression, up to 5 years|First 8 patients in Arm B are from safety cohort, they are not eligible for primary end point||Median survival and CI in months||95% Confidence Interval|Median
115772|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|54 subjects were enrolled and 51 subjects completed the study. Lovastatin plasma concentration data for 48 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 3 subjects. Mevacor® plasma concentration data for 50 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 1 subject.||ng-hr/mL||Standard Deviation|Mean
115773|NCT00685685|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.||ng-hr/mL||Standard Deviation|Mean
115774|NCT00685685|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.||ng/mL||Standard Deviation|Mean
115775|NCT00685659|Secondary|Cocaine Urine Toxicology Results||at baseline, and 3, 6, 9, 12, 18, and 24 mo follow-ups||||||
115776|NCT00685659|Secondary|Percent Days Cocaine Use||at baseline, and 3, 6, 9, 12, 18, and 24 mo follow-ups||||||
115777|NCT00685659|Primary|Abstinence From Cocaine, Alcohol, and Other Drugs.||at baseline, and 3, 6, 9, 12, 18, and 24 mo follow-ups|||participants|||Number
115778|NCT00685516|Secondary|Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).||6 weeks|Pre and post blood samples unavailable for: 4 participants in Arm I (GT group), 3 participants in Arm II (control/water group) and 3 participants in Arm III (BT group).||ng/mL||Standard Deviation|Mean
115779|NCT00685516|Secondary|Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).|Concentration of tea polyphenols and methyl-metabolites in urine after the consumption of GT and BT. No polyphenols were found after water consumption|6 weeks|"Urine concentration of (-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."||umol/g creatinine||Standard Deviation|Mean
115780|NCT00685516|Secondary|Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue|Examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.|6 weeks|"Concentration of tea polyphenols and methyl-metabolites in prostate tissue after the consumption of GT and BT. No polyphenols were found after water consumption.~(-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4-O-methylEGCG (4-OmethylEGCG)."||(pmol/g tissue)||Standard Deviation|Mean
115781|NCT00685516|Primary|Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.|To determine the effect of Green Tea and Black Tea consumption on Prostate cancer tissue by examining programmed cell death, cell proliferation, cell oxidation, and cellular inflammation in that malignant radical prostatectomy tissue compared to water control using immunohistochemistry.|6 weeks|subjects that completed study||percent positive of total cells||Standard Deviation|Mean
115782|NCT00685477|Secondary|Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method||15, 30, 45 and 60 minutes post-infusion|Some participants were excluded from analyses due to location testing procedures||percentage||Standard Deviation|Mean
115783|NCT00685477|Primary|Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method|The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.|15, 30, 45, and 60 minutes post drug infusion|Some participants were excluded from analyses due to location testing procedures||percentage||95% Confidence Interval|Number
115784|NCT00685373|Secondary|Pharmacokinetics|Mean Clearance from serum in Liter per Day (CLD) in adult participants >=18, pediatric participants <18 with body weight >40 kg and pediatric participants <18 with body weight <=40 kg.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety population defined as all participants who received at least 1 dose of study drug. 3 participants were excluded because dosing information was not available at the time of analysis.||L/day||Standard Deviation|Mean
115785|NCT00685373|Secondary|Immunogenicity of Canakinumab (ACZ885)|The number of participants who tested positive for anti-ACZ885 antibodies using the Biacore Assay at the end of the study.|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who received at least one dose of study drug and were tested for anti-ACZ885 antibodies at the end of the study.||participants|||Number
115830|NCT00684671|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptoms = any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31-day follow-up period after the challenge dose.|||Subjects|||Number
115786|NCT00685373|Secondary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers.|"Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal.~Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe."|Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Safety Population defined as all participants who had at least one dose of study drug and were included in the Relapse Assessment.||Percentage of participants|||Number
115787|NCT00685373|Primary|The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions|The number of participants with Adverse Events and Infections & Infestations are regardless of study drug relationship by primary system organ class preferred term equal and/or greater than 2% in any group. The number of participants with mild injection site reactions= mild reactions observed on at least one occasion but no moderate or severe reactions. The number of participants with moderate injection site reactions= moderate reactions observed on at least one occasion but no severe reactions.|2 years depending on when the participant enters the study|Safety Population defined as all participants who received at least one dose of study drug.||participants|||Number
115788|NCT00685334|Secondary|Treatment Compliance|Total number of randomized patients that completed the full 12 weeks of treatment.|Measured at Week 12||||||
115789|NCT00685334|Secondary|Medication Side Effects|Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.|Measured at Week 12||||||
115790|NCT00685334|Primary|Tolerability|This study addressed the benefits, tolerability, acceptability, safety, and appropriate dosage of olanzapine and aripiprazole, as determined by clinical evaluation and self report. The outcome measure reported here is the number of patients who did not experience untoward side effects while taking the medication.|Measured at Week 12|Data was not available for all 22 participants.||Participants|||Number
115791|NCT00685334|Primary|Change From Baseline in Weight (Lbs.) at 12 Weeks|This study looked at change in weight before and after medication use.|baseline and 12 weeks|||lbs||Standard Deviation|Mean
115792|NCT00685295|Secondary|Occurrence of Untoward Opioid Side Effects|Subjects were monitored for any signs of untoward opioid side effects.|120 minutes|||Participants|||Count of Participants
115793|NCT00685295|Primary|Pain Reduction|Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).|60 minutes|||Participants|||Count of Participants
115794|NCT00685295|Primary|Time to Analgesia|Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)|60 minutes|||minutes||Inter-Quartile Range|Median
115795|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.||ng-hr/mL||Standard Deviation|Mean
115796|NCT00685165|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.||ng-hr/mL||Standard Deviation|Mean
115797|NCT00685165|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 18, 24, 36, 48, 60 and 72 hours after drug administration.|Plasma concentration data for 21 of 22 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing due to an adverse event.||ng/mL||Standard Deviation|Mean
115798|NCT00685139|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
115799|NCT00685139|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 33 out of 34 subjects who completed this study. One subject elected to withdraw prior to the study hour 2 blood sample collection during period II.||ng/mL||Standard Deviation|Mean
115800|NCT00685035|Secondary|Patients' Perceived Comfort Using the Different Settings for the Vest Device|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable). Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."|Immediately following each airway clearance therapy on day 1 and day 4|power calculation not performed for secondary outcomes||units on a scale||Full Range|Median
115801|NCT00685035|Secondary|Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."|Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4|power calculation not performed for secondary outcomes||dynes/cm^2||Full Range|Median
115802|NCT00685035|Secondary|Pre vs. Post Therapy Spirometry|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.|Prior to and following each airway clearance therapy session on days 1 and 4|Power calculation not performed for secondary outcomes.||ml||Standard Deviation|Mean
115803|NCT00685035|Primary|Sputum Wet and Dry Weight|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container."|Produced during each airway clearance therapy session on days 1 and 4|In a previous study with similar design,21 the standard deviation for the difference in the mean sputum wet weight between treatment arms was 4.6 g. Assuming the same standard deviation for the current study, enrollment of 16 subjects provided an 80% chance of detecting a 3.5-g difference in the sputum wet weights at a significance level of .05.||grams||Full Range|Median
115804|NCT00684996|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for the first 8 weeks for dose-limiting toxicities, then assessed for adverse events after every cycle (1 cycle = 28 days) of protocol treatment, up to 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
115805|NCT00684996|Primary|Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST), Including Confirmed and Unconfirmed Complete and Partial Responses (Phase II)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of nonmeasurable disease. No new lesions.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
115806|NCT00684996|Primary|Overall Survival (Phase II)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|From date of registration to date of death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
115807|NCT00684996|Primary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 (Phase II)|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
115808|NCT00684996|Primary|Progression-free Survival (Phase II)|Measured from date of registration to date of first observation of progressive disease, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|From date of registration to date of first observation of progressive disease, systemic deterioration, or death due to any cause, assessed up to 3 years|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
115809|NCT00684996|Primary|Maximum Tolerated Dose of Bevacizumab , Based on Incidence of Dose-limiting Toxicity (DLT) Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)||Up to 8 weeks|The study was permanently closed to accrual on April 1, 2009, due to drug supply issues.|||||
115810|NCT00684983|Secondary|Adverse Event Profile as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0||Up to 5 years||||||
115811|NCT00684983|Secondary|Duration of Response|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|Up to 5 years||||||
115812|NCT00684983|Secondary|Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)||Up to 5 years||||||
115813|NCT00684983|Secondary|Time to Treatment Failure|Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.|From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years||||||
115814|NCT00684983|Secondary|Overall Survival|Median Survival time (months)|From randomization to death due to any cause, up to 5 years||||||
120450|NCT00639717|Secondary|The Percentage of Patients That Experienced Graft Versus Host Disease|Incidence of acute GVHD grades 2-4 and chronic GVHD in this study population|6 Months|||percentage of patients||95% Confidence Interval|Number
115816|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.||ng-hr/mL||Standard Deviation|Mean
115817|NCT00684814|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.||ng-hr/mL||Standard Deviation|Mean
115818|NCT00684814|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 31 of 38 participants were used in the statistical analysis. Six subjects dropped from study period I and one subject dropped from study period II.||ng/mL||Standard Deviation|Mean
115819|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable cilostazol (reference and test) plasma concentration to the elimination rate constant.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 26 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used. Additionally, two subjects had data values that were not used in this analysis.||ng-hr/mL||Standard Deviation|Mean
115820|NCT00684762|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable cilostazol (test and reference) concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.||ng-hr/mL||Standard Deviation|Mean
115821|NCT00684762|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that cilostazol (test and reference product) reaches in the plasma.|serial pharmacokinetic concentrations were drawn pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 16, 24, 36 and 48 hours post-dose.|Plasma concentration data for 28 of the 32 enrolled participants were used in the statistical analysis. Four subjects did not complete the study and none of their collected data was used.||ng/mL||Standard Deviation|Mean
115822|NCT00684749|Secondary|Surgeon Satisfaction With Outcome|Patient completedsurvey regarding outcome|1 Year||||||
115823|NCT00684749|Secondary|Patient Satisfaction With Outcome|Patient completed a survey regarding outcome|1 Year||||||
115824|NCT00684749|Primary|Reoperation Rates|Surgeon completed survey|2 years|All patients who were treated in the time period||participants|||Number
115825|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
115826|NCT00684723|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng-hr/mL||Standard Deviation|Mean
115827|NCT00684723|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.|||ng/mL||Standard Deviation|Mean
115828|NCT00684671|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|During one month following the administration of the challenge dose|||Subjects|||Number
115829|NCT00684671|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or is a sign of suspected or confirmed hepatitis A or hepatitis B.|Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year)|||Subjects|||Number
115833|NCT00684671|Secondary|Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations are given as geometric mean concentration (GMCs) expressed as mIU/mL.|Prior to administration of challenge dose|Analysis was performed on the Long-Term According-to-Protocol (LT ATP) cohort for analysis of immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
115834|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|"Anamnestic response was defined as :~for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL),~for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
115835|NCT00684671|Primary|Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies|"Anamnestic response was defined as:~for initially seronegative subjects, antibody concentration greater than or equal the cut-off [≥ 15 Milli-International Units per Milliliter (mIU/mL)],~for initially seropositive subjects with pre-vaccination antibody, concentration < 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration,~for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration."|One month after the challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
115836|NCT00684645|Other Pre-specified|Percentage of Participants Responding to Treatment|Response categories for target lesions: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest dimensions, reference=baseline sum of longest dimensions; Progressive disease (PD): At least a 20% increase in the sum of the longest dimensions, or the appearance of 1 or more new lesions; Stable disease (SD): Not sufficient shrinkage to qualify for PR, not sufficient increase to qualify for PD; Reference for PD and SD: smallest sum of longest dimensions since treatment started.|12 months|All participants||percentage of participants|||Number
115837|NCT00684645|Other Pre-specified|Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade|Sunitinib-induced hypertension: not present at baseline but developed through the study, or if present at baseline increased by more than (>) 20% during the study. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20 millimeters of Mercury (mm Hg) (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL); Grade 2: Recurrent or persistent (>=24 hours) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL; Grade 3: Requiring >1 drug or more intensive therapy than previously; Grade 4: Life-threatening; Grade 5: Death.|Baseline up to 12 months|All participants||percentage of participants|||Number
115838|NCT00684645|Other Pre-specified|Summary of Adverse Events for Participants Who Required Dose Modification|Adverse events (AEs) or treatment-emergent adverse events (TEAEs) were defined as newly occurring or worsening after first dose. Study drug modifications included reduced dose or temporary discontinuation of treatment.|Baseline up to 12 months|Number of participants analyzed = All participants who required dose modification because of an adverse event. The total number of participants may exceed the number of participants analyzed because one participant may have reported more than one adverse event.||participants|||Number
115839|NCT00684645|Primary|Percentage of Participants With Hypertension|Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than [<]24 hours) increase by >20mm Hg (diastolic) or to >150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by >20 mm Hg (diastolic) or to >150/100 mm Hg if previously WNL. Grade 3: Requiring >1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.|Baseline, Week 6, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.||percentage of participants|||Number
115840|NCT00684645|Primary|Percentage of Participants With Hypothyroidism|TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level >5.0 mIU/L at that time point.|Baseline, Months 3, 6, 9, 12|FAS. n = number of participants with evaluable data at that time point.||percentage of participants|||Number
115841|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.|Baseline to date of death (up to 12 months)|FAS||participants|||Number
115842|NCT00684645|Primary|Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)|Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).|Baseline to date of first documentation of response to treatment (up to 12 months)|FAS||participants|||Number
115843|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 12|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
115856|NCT00684593|Primary|Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29|PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).|Baseline and Day 29|The population consisted of all treated participants with follow-up.||Score on a Scale||Standard Deviation|Mean
115844|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 9|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
115845|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 6|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
115846|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Month 3|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
115847|NCT00684645|Primary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6|"Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in Not reported category were on study, had no data for this time point."|Week 6|FAS. Percentages based on entire FAS population.||percentage of participants|||Number
115848|NCT00684645|Primary|Overall Survival (OS)|OS is the duration from enrollment to death.|Baseline to date of death (up to 12 months)|FAS||months||95% Confidence Interval|Median
115849|NCT00684645|Primary|Progression-free Survival (PFS)|The period from study entry until disease progression, death, or date of last contact.|Baseline to measured progressive disease (up to 12 months)|FAS||months||95% Confidence Interval|Median
115850|NCT00684645|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 months|Full analysis set (FAS): all participants who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Number
115851|NCT00684593|Secondary|Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Tmax at Day 28.||Hours||Full Range|Median
115852|NCT00684593|Secondary|Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable for T1/2. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing. An additional 2 participants were excluded from the population because their T1/2 was incalculable.||Hours||Standard Deviation|Mean
115853|NCT00684593|Secondary|Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all enrolled participants for which serum samples were evaluable at Day 28 for AUC (0-24). One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.||hr*ng/mL||Standard Deviation|Mean
115854|NCT00684593|Secondary|Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28|Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.|Day 28|The population consisted of all participants for which serum samples were available for the determination of Cmax at Day 28. One participant was excluded due to erroneous blood sample collection relative to Navarixin dosing.||ng/mL||Standard Deviation|Mean
115855|NCT00684593|Secondary|Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29|The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.|Day 29|The population consisted of all treated participants with follow-up.||Participants|||Number
115898|NCT00684307|Primary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with ALAT>=3 times upper limit of normal.l|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)|||Participants|||Number
115857|NCT00684567|Secondary|Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response|"CR = measurable lesion disappeared.~PR = total sum of lesions measurable in bidimension decreased by 50% or more on whole and no secondary progression attributable to tumor was noted. No onset of new lesion."|1 year after the start of administration in the concomitant radiotherapy phase|Response rate in terms of tumor response (ratio of CR + PR) in 19 participants was assessed by Efficacy and Safety Evaluation Committee. 19 participants were found to have measurable lesions. Nineteen participants (as opposed to 30 participants) were analyzed because that is how many participants were still alive 1 year after start of therapy.||Participants|||Number
115858|NCT00684567|Secondary|Number of Participants With Progression Free Survival (PFS) for 1 Year|Administration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).|1 year after the start of admininstration in the concomitant radiotherapy phase|||Participants|||Number
115859|NCT00684567|Primary|Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy|||Participants|||Number
115860|NCT00684567|Primary|Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.|until 30 days after the completion of administration of monotherapy|||Participants|||Number
115861|NCT00684567|Primary|Adverse Events With an Incidence of Greater Than or Equal to 20%|Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.|until 30 days after the completion of administration of monotherapy|||Participants|||Number
115862|NCT00684554|Secondary|Prolonged Withdrawal|participants experiencing prolonged withdrawal beyond two days after buprenorphine induction|a) 2 days|participants who initiated induction||participants|||Number
115863|NCT00684554|Primary|The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.|The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.|one week after initial primary care visit|patients who in initiated induction||participants|||Number
115864|NCT00684541|Secondary|Social Phobia and Agoraphobia Inventory|Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory.|Pre, Post (6 weeks), Followup (3 months after post-assessment)|||units on a scale||Standard Deviation|Mean
115865|NCT00684541|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms.|Pre, Post (6 weeks), Followup (3 months after post-assessment)|||units on a scale||Standard Deviation|Mean
115866|NCT00684515|Secondary|Mean Membrane-Bound P-Selectin Levels By Study Visit|Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had membrane-bound p-selectin data available.||Arbitrary Units||Standard Error|Mean
115867|NCT00684515|Secondary|Mean CD40 Ligand Levels By Study Visit|Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had CD40 ligand data available.||mg/L||Standard Error|Mean
115868|NCT00684515|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit|Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden.|Up to Day 60|The population consisted of all enrolled participants who received at least one dose of study drug and had hs-CRP data available.||mg/L||Standard Deviation|Median
115869|NCT00684515|Secondary|Number of Participants With MACE or Death|The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.||Participants|||Number
115870|NCT00684515|Secondary|Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events|Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding.|Up to Day 60|The population consisted of all enrolled participants that received at least one dose of study drug and had TIMI bleeding data available.||Participants|||Number
115899|NCT00684307|Primary|Creatinine|Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)|||umol/L||Standard Deviation|Mean
115871|NCT00684515|Primary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis.|Up to Day 121|The population consisted of all enrolled participants that received at least one dose of study drug.||Participants|||Number
115872|NCT00684424|Secondary|Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.|Baseline, Week 16 (Final Visit)|FAS. Abbreviations: BL = Baseline; FV = Final Visit.||participants|||Number
115873|NCT00684424|Secondary|Medical Outcomes Sleep Scale (MOS-S)|MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 16 (Final Visit )|FAS. A subscale was classified as missing if any of the questions used in the calculation were missing. Abbreviations: BL = Baseline, SOB = short of breath.||scores on scales||Standard Deviation|Mean
115874|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)|CGI-C scale: physician’s global impression of a subject’s clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.|Week 16 (Final Visit)|FAS||participants|||Number
115875|NCT00684424|Secondary|Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S scale: physician’s global impression of a subject’s clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.|Baseline|FAS||participants|||Number
115876|NCT00684424|Secondary|Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.|Baseline, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.||mm||Standard Deviation|Mean
115877|NCT00684424|Secondary|Visual Analog Scale of Anxiety (VAS-A)|Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.|Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward|FAS; Last observation carried forward (LOCF) method: subject’s last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.||mm||Standard Deviation|Mean
115878|NCT00684424|Secondary|Average Dosage of Pregabalin Taken at Baseline and Final Visit|Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.|Baseline, Week 16 (Final Visit )|Safety analysis set.||participants|||Number
115879|NCT00684424|Secondary|Concomitant Drug Treatments|Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.|Baseline through Week 16 (Final Visit)|Safety analysis set.||participants|||Number
115880|NCT00684424|Secondary|Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study|Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.|Week 8 up to Week 16 (Last 4 weeks of the treatment period)|FAS||participants|||Number
115881|NCT00684424|Secondary|Change in 28 Day Partial Seizure Frequency|Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.|Baseline through Week 16 (Final Visit )|FAS. Subjects who discontinued less than 4 weeks into the treatment period or with missing date of the attack were excluded from analyses.||number of seizures per 28 days||Standard Deviation|Mean
115882|NCT00684424|Secondary|Antiepileptic Drugs Used in the Past|Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.|Baseline|Safety analysis set: all subjects who received at least 1 dose of study medication.||participants|||Number
115900|NCT00684307|Primary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)|||Participants|||Number
115901|NCT00684255|Secondary|Progression Free and Overall Survival.|Probability of progression free and overall survival will be measured.|1 year||||||
115883|NCT00684424|Primary|Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency|Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.|Baseline through Week 16|Full Analysis Set: all subjects who received at least 1 dose of study drug and had at least 1 efficacy measurement.||participants|||Number
115884|NCT00684411|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival for the earlier of 6 weeks from the end of treatment or death. Maximum follow-up was 288 days in this study cohort.|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.||days||90% Confidence Interval|Median
115885|NCT00684411|Secondary|Progression-Free Survival|"Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Disease progression was assessed per International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].~Per International Working Group response criteria in lymphoma progressive disease (PD) was defined as the appearance of new lesions; the sum of the product of the diameter (SPD) increasing ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall; or, in any single nodal target lesion, a node with a short axis > 10 mm must increase > 50% in greatest transverse diameter or a node with short axis <10mm must increase by at least 50% to at least 15 mm x 15 mm or have a greatest transverse diameter greater than 15 mm."|Disease was evaluated radiologically at baseline, on treatment at weeks 8, 16, 24 and every 12 weeks thereafter, off treatment for 6 weeks or until death, whichever occurs first. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.||days||90% Confidence Interval|Median
115886|NCT00684411|Primary|Overall Response Rate|"Overall response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on International Workshop Criteria (IWC) [Cheson, et al. JCO 2007].~Per the International Working Group response criteria in lymphoma (Cheson 2007) for target lesions assessed by CT: Complete response (CR): nodes that were greater than 15 mm in greatest transverse diameter at baseline shrank to less than 15 mm in greatest transverse diameter and those that were 11-15 mm in greatest transverse diameter but had a short axis diameter greater than 10 mm had a short axis diameter less than 10mm and a transverse diameter that remained less than 15 mm; partial response (PR) was defined as a decrease in the sum of the product of the diameter of target lesions by more than 50% but not fulfilling criteria for CR. Overall response was defined as CR+PR."|Disease was evaluated radiologically at baseline, weeks 8, 16, 24 and every 12 weeks thereafter on treatment. Treatment duration was a median of 56 days (range 5-253 days).|The analysis dataset is comprised of disease evaluable participants. One patient was ineligible based on diagnosis of diffuse large B-cell lymphoma.||proportion of participants||90% Confidence Interval|Number
115887|NCT00684320|Secondary|Social Phobia and Anxiety Inventory|Our primary self-report outcome measure was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), which consists of 45 items assessing the cognitive, behavioral, and somatic dimensions of SP. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. This measure has strong psychometric properties (Turner et al., 1989) and has been widely used in previous treatment outcome research in SP (e.g., Clark et al., 2006).|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)|||units on a scale||Standard Deviation|Mean
115888|NCT00684320|Primary|Liebowitz Social Anxiety Scale (LSAS)|Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms|Pre-Treatment, Post-Treatment (6 weeks)|||units on a scale||Standard Deviation|Mean
115889|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC|Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol|||L/h||Full Range|Median
115890|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC|Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T|36 weeks according to protocol|||L/h||Full Range|Median
115891|NCT00684307|Secondary|Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT|Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T|36 weeks according to protocol|||L/h||Full Range|Median
115892|NCT00684307|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol|||nmol/L||Full Range|Median
115893|NCT00684307|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment made on the week 12 visit|12 weeks after baseline according to protocol|||nmol/L||Full Range|Median
115894|NCT00684307|Secondary|Ecarin Clotting Time (ECT)|Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)|||sec||Full Range|Median
115895|NCT00684307|Secondary|Activated Partial Thromboplastin Time (APTT)|Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)|12 weeks according to protocol.(baseline to week 12 visit)|||sec||Full Range|Median
115896|NCT00684307|Secondary|D-Dimer|Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)|14 weeks according to protocol.(enrolment to week 12 visit)|||ng/mL||Full Range|Median
115897|NCT00684307|Primary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal|36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)|||Participants|||Number
115905|NCT00684242|Primary|Change in Cancer Pain Intensity Determined by Edmonton Symptom Assessment Scale (ESAS)|"Changes in cancer pain from baseline to day 15 using ESAS to measure participant responses to 10 common symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, sleep problems, and feeling of well-being). Intensity of symptoms rated on a 0 to 10 scale from 0 no symptom to 10 worst possible symptom."|From baseline to Day 15|One participant was not evaluable for Day 15.||units on a scale|||Number
115906|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI That Had Clinically Important Bleeding Events|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring blood transfusion, bleeding requiring hospitalization, and TIMI major bleeding. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had bleeding event data available.||Participants|||Number
115907|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the mean serum level of CD40 ligand. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had CD40 ligand data available.||ng/mL||Standard Error|Mean
115908|NCT00684203|Secondary|Median Hs-CRP Levels Among Participants Who Did Not Undergo PCI|Participant blood samples were collected at baseline and at the time of hospital discharge to determine the median serum level of hs-CRP. Analysis of data was by loading dose group.|Baseline Up To Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hs-CRP data available.||mg/L||Standard Deviation|Median
115909|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Subsequent Hospitalization|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants who required a subsequent hospitalization. Analysis of data was by loading dose group.|Up to Day 30|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had hospitalization data available.||Participants|||Number
115910|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Bleeding Events That Required Transfusion|Bleeding events were evaluated among participants that did not undergo PCI to determine the number of participants that required blood transfusion. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had transfusion data available.||Participants|||Number
115911|NCT00684203|Secondary|Number of Participants Who Did Not Undergo PCI But Had Coronary Artery Bypass Graft (CABG) Who Experienced Bleeding Events|Bleeding events were evaluated up to 10 hours post-CABG among participants who did not undergo PCI.|Up to 10 Hours Post-CABG|Evaluation of the bleeding events associated with CABG occurring after Vorapaxar treatment was not analyzed since only three participants in the non-PCI cohort underwent CABG in this study.|||||
115912|NCT00684203|Secondary|Number of Participants Experiencing Non-MACE AEs Among Participants Who Did Not Undergo PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal MI, nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading dose group.|Up to Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had non-MACE AE data available.||Participants|||Number
115913|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-TIMI Bleeding Events Among Participants Who Did Not Undergo PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo MRI), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by loading dose group.|Up to Day 60|The population consisted of all enrolled participants who received at least 1 dose of study drug, did not undergo PCI, and had TIMI bleeding data available.||Participants|||Number
115914|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Clinically Important Bleeding Events During Treatment and After Hospital Discharge|Clinically important bleeding events were defined as intracranial hemorrhage, bleeding requiring hospitalization, or TIMI major bleeding. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all participants who received at least 1 dose of study drug, underwent PCI, and had bleeding event data.||Participants|||Number
115915|NCT00684203|Secondary|Mean Membrane-Bound P-Selectin Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of membrane-bound P-selectin. Membrane-bound P-selectin was measured using flow cytometry and a monoclonal antibody to P-selectin. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants that received at least 1 dose of study drug and underwent PCI with membrane-bound P-selectin data available.||Arbitrary Units||Standard Error|Mean
115916|NCT00684203|Secondary|Mean CD40 Ligand Levels Among Participants Who Underwent PCI|Participant blood samples were collected at Baseline and Days 30 and 60 to evaluate the mean level of CD40 ligand present. CD40 ligand is a protein primarily found on activated T-cells, with higher levels indicating better immunological health. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with CD40 ligand data available.||ng/mL||Standard Error|Mean
115938|NCT00684060|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end diastolic index from baseline to six months."||mL/m2||Standard Deviation|Mean
115917|NCT00684203|Secondary|Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels Among Participants Who Underwent PCI By Study Visit|Participant blood samples were collected at Baseline and on Days 30 and 60 to evaluate the median level of hs-CRP. hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with hs-CRP data available.||mg/L||Inter-Quartile Range|Median
115918|NCT00684203|Secondary|Number of Participants Who Underwent PCI With Inhibition of Platelet Aggregation By Study Visit|Blood samples were collected from participants at Baseline and Days 30, 60, 74, 90, and 121 to determine the extent of inhibition of platelet aggregation induced by thrombin-receptor agonist peptide (TRAP). Analysis of data was by maintenance dose group.|Baseline, Day 30, Day 60, Day 74, Day 90, Day 121|The population consisted of all enrolled participants who received at least 1 dose of study drug and underwent PCI with inhibition of platelet aggregation data available.||Participants|||Number
115919|NCT00684203|Secondary|Number of Participants With Major, Minor, and Non-Thrombolysis in Myocardial Infarction Cooperative Group (TIMI) Bleeding Events Among Participants Who Underwent PCI|Major TIMI bleeding was defined as any intracranial bleeding (excluding microhemorrhages <10 mm evident only on gradient-echo magnetic resonance imaging [MRI]), clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI bleeding or Minor TIMI bleeding. Analysis of data was by maintenance dose group.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with TIMI bleeding data available.||Participants|||Number
115920|NCT00684203|Secondary|Number of Participants Experiencing Non-Major Adverse Cardiac Events (MACE) Who Underwent PCI|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization performed ≥ 30 days after administration of the loading dose (Day 1). All MACE events were excluded from this analysis. Analysis of data was by loading/maintenance dose group.|Up to Day 121|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI with Non-Major MACE data available.||Participants|||Number
115921|NCT00684203|Primary|Number of Participants Experiencing Adverse Events (AEs) Who Underwent Percutaneous Coronary Interventions (PCI)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to Day 60|The population included all enrolled participants who received at least 1 dose of study drug and underwent PCI.||Participants|||Number
115922|NCT00684177|Secondary|Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)|"Therapeutic Success (Succ) was referred to as both Clinical Succ and Microbiological (Micro) Succ at Follow-up. Clinical Succ was the Resolution of baseline signs/symptoms of infection with a pus score of 0. A participant was Micro Succ if the micro outcome for all baseline pathogens (bps) belonged to Eradication (elimination of bps), Presumed Eradication (clinical outcome is success; no culturable material), or Colonization (new pathogen is identified at end of therapy in participants who are resolved/improved). All other combinations were deemed Therapeutic Failures."|Follow-up (Days 12-14)|ITTB subset of Primary Efficacy Population||participants|||Number
115923|NCT00684177|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The results presented below pooled all baseline pathogens (bps). Eradication: elimination of bps. Presumed Eradication: clinical outcome was success; no culture was obtained due to lack of culturable material. Presumed Improvement: clinical outcome was improvement such that no culture was obtained due to lack of culturable material. Persistence: bps still present. Presumed persistence: clinical failure and no culture was obtained."|Days 7-9|ITTB subset of Primary Efficacy Population||baseline pathogens|||Number
115924|NCT00684177|Secondary|Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)|Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; clinical failure, insufficient improvement of deterioration of S/S of infection recorded at BL such that additional antibiotic therapy is required; unable to determine.|Days 7-9|Primary Efficacy Population||participants|||Number
115925|NCT00684177|Secondary|Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)|"The by pathogen microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The by subject microbiological response was Microbiological Success if the microbiological outcomes for all baseline pathogens (bps) belong to Eradication (elimination of bps), Presumed Eradication (clinical outcome was success; no culture was obtained due to lack of culturable material), or Colonization (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was Microbiological Failure."|Days 12-14|ITTB subset of Primary Efficacy Population||participants|||Number
115926|NCT00684177|Secondary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population|"“Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|ITTB subset of Primary Efficacy Population: participants in the Primary Efficacy Population (see analysis population description in the Primary Outcome section) who had at least one pathogen isolated at the baseline visit.||participants|||Number
115927|NCT00684177|Primary|Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population|"“Clinical Success at follow-up was defined as Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of 0. Clinical response at follow-up was classified as Clinical Failure for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items."|Days 12-14|Primary Efficacy Population: ITTC participants (par.) with baseline pus/exudate >=3 who were enrolled under the original protocol with data captured under eCRF V1 and who were enrolled under protocol amendments with data captured under eCRF V2; ITTC (Intent-to-treat Clinical): all randomized par. who received at least one dose of study medication.||participants|||Number
115928|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
115929|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
115930|NCT00684138|Secondary|Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)|Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
115931|NCT00684138|Secondary|Binocular Distance Corrected Distance Visual Acuity|Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).|3 months post-operative|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
115932|NCT00684138|Primary|Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)|Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.|3 months|Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).||logMAR||95% Confidence Interval|Mean
115933|NCT00684073|Primary|Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®).|"Score of 0 = Not satisfied at all; Score of 10 = Totally satisfied"|Each treatment Day (post-dose on days 1-5)|Intent to Treat (ITT) - each day's results were based on number of subjects who had a Day 1 visit.||centimeters||Standard Deviation|Mean
115934|NCT00684060|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|"Five patients were excluded from analysis due to incomplete signal intensity enhancement data (1) or lack of a signal intensity enhancement signal in the border zone (4).~Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months."||mm||Standard Deviation|Mean
115935|NCT00684060|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included. One patient was excluded from the analysis due to incomplete signal intensity enhancement data.~Values reported represent the change in wall motion over time in the infarct zone from baseline to six months."||mm||Standard Deviation|Mean
115936|NCT00684060|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in infarct volume from baseline to six months."||mL||Standard Deviation|Mean
115937|NCT00684060|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end systolic volume index from baseline to six months."||mL/m2||Standard Deviation|Mean
120451|NCT00639717|Primary|Percentage of Patients Who Experienced Relapse by 6 Months|Relapse rate at 6 months. Relapse is defined as recurrence of disease.|6 months|||Percentage of patients||95% Confidence Interval|Number
115940|NCT00684060|Secondary|Combined Endpoint|Combined endpoint: first of death, reinfarction, repeat revascularization, and hospitalization for heart failure. This is measured as the number of events by treatment group over the 6 month follow up period.|Measured at Baseline and Month 6|All randomized patients were followed for clinical outcomes. However the paucity of events precluded a reliable time to event analysis.||events|||Number
115941|NCT00684060|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in Global EF from baseline to six months."||percentage of ejection fraction||Standard Deviation|Mean
115942|NCT00684047|Secondary|Prevalence of Treatment Failures|The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population||percentage of participants|||Number
115943|NCT00684047|Secondary|Proportions of Subjects Achieving Hemostasis|The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II)|10 minutes from the start of treatment application at the target bleeding site|intent to treat population||percentage of participants|||Number
115944|NCT00684047|Primary|The Primary Efficacy Endpoint is Time to Hemostasis.|The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved.|The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved.|||percentage of subjects|||Number
115945|NCT00684021|Primary|Regional Left Ventricular Function (Border Zone Wall Motion)|Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.|Measured at Baseline and Month 6|Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.||mm||Standard Deviation|Mean
115946|NCT00684021|Primary|Regional Left Ventricular Function (Infarct Zone Wall Motion)|One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month MRI images available are included. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.||mm||Standard Deviation|Mean
115947|NCT00684021|Secondary|Infarct Volume|Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in infarct volume from baseline to six months."||mL||Standard Deviation|Mean
115948|NCT00684021|Secondary|End Systolic Volume Index|Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end systolic volume index from baseline to six months."||mL/m2||Standard Deviation|Mean
115949|NCT00684021|Secondary|End Diastolic Volume Index|Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV end diastolic index from baseline to six months."||mL/m2||Standard Deviation|Mean
115950|NCT00684021|Secondary|Left Ventricular Mass|Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in LV mass from baseline to six months."||g||Standard Deviation|Mean
115951|NCT00684021|Secondary|Clincal and Safety Outcomes|Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements|Measured from baseline to six months.|All randomized patients were followed for clinical outcomes.||events|||Number
115952|NCT00684021|Primary|Global Left Ventricular Function|Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.|Measured at Baseline and Month 6|"Only participants with both baseline and 6 month MRI images available are included.~Values reported represent the change in Global EF from baseline to six months."||percentage of ejection fraction||Standard Deviation|Mean
115953|NCT00683930|Secondary|Duration of Prednisone Maintenance Dosing|The duration of prednisone maintenance dosing was defined as the number of days that subjects maintained a prednisone dose of not more than 10 mg/day in the absence of new persistent lesions.|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day = 21; MMF 3 g/day = 37; MMF Groups Combined (2 g/day or 3 g/day) = 58.||Days||Inter-Quartile Range|Median
115954|NCT00683930|Secondary|Time to Sustained Response|Time to sustained response is defined as the week the subject first demonstrates both of the conditions of responder status provided the conditions are maintained through to study termination at Week 52. If a subject does not have a sustained response, time to sustained response is censored on the last day of the study.|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 20; MMF 2 g/day or 3 g/day = 58, subjects censored = 23.||Weeks||Full Range|Median
115955|NCT00683930|Secondary|Time to Initial Response|Time to initial response defined as the time that the subject first demonstrated responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52)|up to 52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36, subjects censored = 7; MMF 2 g/day or 3 g/day = 58, subjects censored = 10.||Weeks||Inter-Quartile Range|Median
115956|NCT00683930|Primary|Percentage of Patients Achieving Responder Status at Week 52|The proportion of subjects achieving responder status (defined as no new persistent lesions and prednisone dose of not more than 10 mg/day from Week 48 until study termination at Week 52) in the two active treatment groups combined (2 g/day and 3 g/day mycophenolate mofetil) compared with the placebo group|52 weeks|Intent-to-treat population. Analysis population (AP): Placebo = 36; MMF 2 g/day or 3 g/day = 58.||Percentage of Participants|||Number
115957|NCT00683917|Primary|The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.||4 months|Study prematurely terminated|||||
115958|NCT00683904|Secondary|Total Body Clearance of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||Liters/hour||Standard Deviation|Mean
115959|NCT00683904|Secondary|Volume of Distribution at Steady State of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||Liters||Standard Deviation|Mean
115960|NCT00683904|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||ng*h/mL||Standard Deviation|Geometric Mean
115961|NCT00683904|Secondary|Time of Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||Hours||Standard Deviation|Mean
115962|NCT00683904|Secondary|Maximum Observed Plasma Concentration of Ixabepilone||Days 1 to 8 of Cycle 1 (21 days)|All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles||ng/mL||Standard Deviation|Geometric Mean
115963|NCT00683904|Secondary|Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment|Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met.|Days 1 through 21 (Cycle 1)|All treated participants with measurable disease at baseline, as determined by investigator||Participants|||Number
115964|NCT00683904|Secondary|Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status|Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.|At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)|||Participants|||Number
115965|NCT00683904|Secondary|Number of Participants With Abnormalities in Blood Pressure and Heart Rate|Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE.|At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)|||Participants|||Number
115966|NCT00683904|Secondary|Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade|Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry.|At screening and Days 8 and 15 of Cycle 1 (21 days)|||Participants|||Number
115967|NCT00683904|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade|ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L)|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
115968|NCT00683904|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade|"LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365)~Appendix 7.1.2"|At screening and Days 8 and 15 of Cycle 1 (21 days)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
115969|NCT00683904|Secondary|Number of Participants With Grade 3 or Greater Treatment-related AEs|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All subjects who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
115970|NCT00683904|Secondary|Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation|An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
120452|NCT00639717|Primary|Percentage of Patients Alive at 6 Months|Overall survival at 6 months|6 months|||percentage of patients||95% Confidence Interval|Number
115971|NCT00683904|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin||mg/min/mL|||Number
115972|NCT00683904|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.|Days 1 through 21 (Cycle 1)|All participants who received at least 1 dose of either ixabepilone or carboplatin||Participants|||Number
115973|NCT00683826|Primary|Weight||at the end of each study treatment arm (six weeks)||||||
115974|NCT00683826|Secondary|Energy Expenditure||will be measure at the end of each treatment period (6 weeks)||||||
115975|NCT00683826|Primary|Effects on Weight||4 weeks|||kilograms||Standard Deviation|Mean
115976|NCT00683800|Other Pre-specified|Number of Participants With Hepatic Events|Hepatic events were defined as incidence of increased Liver Function Test (AST [aspartate aminotransferase] or ALT [alanine aminotransferase]) levels greater than 5 times the ULN (upper limit of normal).|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
115977|NCT00683800|Other Pre-specified|Number of Participants With Ischemic Heart Disease|"Potential ischaemic cardiac events were identified using the Standardized MedDRA Query (SMQ) Ischemic Heart Disease."|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
115978|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Probable TIA|Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for “central nervous system haemorrhages and cerebrovascular conditions”. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
115979|NCT00683800|Other Pre-specified|Number of Participants With Adjudicated Cerebrovascular Events - Any Stroke|Adjudicated cerebrovascular events were identified using Standardized MedDRA Query (SMQ), for “central nervous system haemorrhages and cerebrovascular conditions”. Primary assessments included: 1) definite stroke, 2) probable stroke, 3) probable transient ischemic attack (TIA), and 4) no stroke or TIA.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
115980|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
115981|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
115982|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
115983|NCT00683800|Secondary|Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
115984|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
116097|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
115985|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12|PGI-C score was intended to assess the study participant’s perception of changes in hot flushes. It was 7-point scale which ranged from 1 (Very Much Improved) to 7 (Very Much Worse).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
115986|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
115987|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
115988|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|MITT population: All participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms recorded on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks of therapy. LOCF method was used. Participants analyzed included those who were evaluated for this particular scale.||Percentage of Participants|||Number
115989|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
115990|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
115991|NCT00683800|Secondary|Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12|PGI-R scale was intended to assess the study participant's perception of symptoms. Participants were requested to identify the severity of their hot flush symptoms. It was a 5-scale which ranged from 1 (None) to 5 (Severe).|Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment. Assessment was done using LOCF method.||Percentage of Participants|||Number
115992|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.||Units on a Scale||Standard Error|Mean
115993|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Month 6|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy GCS assessment or at least 1 on therapy PGI assessment.||Units on a Scale||Standard Error|Mean
116093|NCT00682851|Primary|Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
115994|NCT00683800|Secondary|Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12|GCS: a 21 item evaluation of symptoms which asked participants how bothered they were with particular symptom at the moment. Each item was scored as 0 = Not at all, 1 = A little, 2 = Quite a bit, and 3 = Extremely. A total score was derived from the sum of the 21 items (range 0-63). GCS was also used to generate 6 individual scores (psychological symptoms [range 0-33], anxiety [range 0-18], depression [range 0-15], somatic symptoms [range 0-21], vasomotor symptoms [range 0-6], and sexual dysfunction [range 0-3]). A decrease in the total climacteric score indicated an improvement in symptoms.|Baseline and Week 12|Main study efficacy population included all participants who were randomized; had at least 1 dose of study medication; and had a baseline and at least 1 on therapy Greene Climacteric Scale (GCS) assessment or at least 1 on therapy Patient Global Impression (PGI) assessment.||Units on a Scale||Standard Error|Mean
115995|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12|Severity: mild (heat sensation without sweating); moderate (heat sensation with sweating; able to continue activity); severe (heat sensation with sweating; causing cessation of activity). Average daily severity of hot flushes= (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). Days with no hot flushes: severity score=0. As it was derived from count data, there was no maximum; minimum score=0; higher values= worse outcomes. Adjusted mean: calculated using change from baseline=response variable, treatment=factor and baseline=covariate using observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Units on a Scale||Standard Error|Mean
115996|NCT00683800|Secondary|Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity. Adjusted mean was calculated by using change from baseline as response variable, treatment as factor, and baseline as covariate using the observed cases.|Baseline, Month 6 and Month 12|MITT participants of the efficacy sub-study population who had non-missing average daily number of moderate and severe hot flushes. The assessment was done using observed values. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Hot Flushes||Standard Error|Mean
115997|NCT00683800|Secondary|Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes|Time to response was defined as the time-to-first 50% reduction in the average daily number of moderate to severe hot flushes over 3 consecutive days.|Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy.||Days||95% Confidence Interval|Median
115998|NCT00683800|Secondary|Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Percentage of participants|||Number
115999|NCT00683800|Secondary|Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline, Week 4 and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Percentage of participants|||Number
116000|NCT00683800|Secondary|Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes|A mean decrease from baseline of at least 5.35 moderate to severe hot flushes at week 12 in the participants was considered clinically meaningful.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Participants|||Number
116001|NCT00683800|Primary|Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events|Adjudicated ischemic cardiovascular events were a composite of: a) Coronary Heart Disease (CHD)-related death; b) New Myocardial Infarction (MI) (non-procedure-related MI); c) Documented new onset of unstable angina requiring hospitalization; d) Unscheduled coronary revascularization procedures (percutaneous coronary intervention) or bypass grafting.|Baseline up to Month 12|Safety population included all randomized participants who received at least 1 dose of study medication.||Participants|||Number
116027|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116094|NCT00682838|Primary|Nightly CPAP Adherence|Nightly CPAP adherence hours per night measured over the three-months period|3 mos|||hours per night||Standard Deviation|Mean
116002|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Units on a Scale||Standard Error|Mean
116003|NCT00683800|Primary|Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4|Severity ranged from mild (sensation of heat without sweating); moderate (sensation of heat with sweating; able to continue activity) to severe (sensation of heat with sweating; causing cessation of activity). The average daily severity of hot flushes for each time period was calculated as (1*Number of mild+2*Number of moderate+3*Number of severe)/(Total number of hot flushes). For the days with no hot flushes, the severity score was set as 0. As this was derived from the count data, there was no maximum; the minimum score was 0; the higher values showed worse outcomes.|Baseline and Week 4|MITT population: All participants randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using LOCF method. 1 participant in each group did not have data till Week 4.||Units on a Scale||Standard Error|Mean
116004|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 12|MITT population included all participants who were randomized into efficacy substudy, had at least 1 dose of study drug, had vasomotor symptoms recorded on at least 1 day of baseline period and at least 1 day of on-therapy period during initial 12 weeks of therapy. Assessment was done using last observation carried forward (LOCF) method.||Hot Flushes||Standard Error|Mean
116005|NCT00683800|Primary|Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4|The average daily number of moderate and severe hot flushes was calculated as the sum of the number of moderate and severe hot flushes on each day divided by the number of days with data. Moderate hot flushes: sensation of heat with sweating; able to continue activity; and severe hot flushes: sensation of heat with sweating; causing cessation of activity.|Baseline and Week 4|Modified Intent-to-Treat(MITT) population: Participants randomized into efficacy substudy; at least 1 dose of study drug, vasomotor symptoms on at least 1 day of baseline period and 1 day of on-therapy period during initial 12 weeks. Last observation carried forward (LOCF) method was used. 1 participant in each group did not have data till Week 4.||Hot Flushes||Standard Error|Mean
116006|NCT00683787|Secondary|Toxicity||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
116007|NCT00683787|Secondary|Overall Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
116008|NCT00683787|Secondary|Progression-free Survival||3 years|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
116009|NCT00683787|Primary|Overall Response Rate||1 year|Due to the study's early termination and inadequate number of patients no statistical inference of the primary and secondary aims were carried forth.|||||
116010|NCT00683774|Primary|Level of Circulating D-chiro Inositol (DCI)|Measured circulating concentration of plasma DCI following inhibition of insulin release using diazoxide|12 days|||nmol/mL||Full Range|Mean
116011|NCT00683774|Primary|Renal Clearance of D-chiroinositol (DCI) at 12 Days|Following inhibition of insulin release using diazoxide, measured renal clearance of D-chiro inositol (DCI) via urinary Chiro-inositol dci assay|12 days|||ml/min||Full Range|Mean
116012|NCT00683696|Secondary|Number of Subjects With All-cause Mortality|Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.|Study duration from randomization to study exit||||||
116013|NCT00683696|Secondary|Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life|Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.|Study duration from randomization to study exit for death, 24 months for hospitalization, 6 months for QOL evaluation||||||
116014|NCT00683696|Secondary|Change in Quality of Life Scores From Baseline to 6-Month Follow-up|Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.|6 months||||||
116015|NCT00683696|Secondary|NYHA Classification Change|Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.|6 months||||||
116016|NCT00683696|Secondary|Rate of Worsening Heart Failure Hospitalization (Hospitalizations Per Subject-year)|Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).|Study duration from randomization to study exit||||||
116017|NCT00683696|Primary|Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)|The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.|6 months|The primary safety endpoint included all subjects undergoing an implant procedure.||participants|||Number
116063|NCT00683449|Secondary|FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second.|FEV1 (L) was determined over time using a spirometer. Measure the mean change in FEV1 (L) from Baseline.|Baseline to Hour 2|29 subjects experiencing an acute exacerbation of asthma were at approximately 8 ED sites. The sample size was based on feasibility and precedent for this type of study, rather than statistical considerations.||liters per second||Full Range|Mean
116018|NCT00683696|Primary|Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death|The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.|From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years|This analysis was carried out according to the intention-to-treat principle. Follow-up was censored at study closure, date of death, LVAD, heart transplant, withdrawal from the study, or loss to follow-up, whichever came first. 4 deaths in CRT OFF group and 1 death in CRT ON group were after LVAD/transplant and are not included in this analysis.||participants|||Number
116019|NCT00683657|Secondary|Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4|Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
116020|NCT00683657|Secondary|Change From Baseline in Mean Daily Glucose at Week 4|Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
116021|NCT00683657|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4|Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
116022|NCT00683657|Secondary|Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4|Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
116023|NCT00683657|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.||mg/dL||Standard Error|Mean
116024|NCT00683618|Secondary|Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|from week 6 to week 12|Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised treatment period, they entered into extension treatment period upon investigator’s discretion.||percentage of patients|||Number
116025|NCT00683618|Secondary|6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL); non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL),non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percentage of patients|||Number
116026|NCT00683618|Secondary|Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6|"The percentage of patients achieved LDL-C goal is done in ITT population.~National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal:~Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal < 3.36mmol/L(130mg/dL), non-HDL-C goal < 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk >20%): LDL-C goal< 2.60mmol/L (100mg/dL), non-HDL-C goal < 3.36mmol/L (130mg/dL)"|week 6|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percentage of patients|||Number
116095|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
116028|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116029|NCT00683618|Secondary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116030|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116031|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116032|NCT00683618|Secondary|Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116033|NCT00683618|Secondary|Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116034|NCT00683618|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||Percent change||Standard Error|Least Squares Mean
116035|NCT00683618|Secondary|Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116036|NCT00683618|Secondary|Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.|baseline, 6 weeks|Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.||percent change||Standard Error|Least Squares Mean
116037|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.|baseline, 6 weeks|||Percent change||Standard Error|Least Squares Mean
116038|NCT00683618|Primary|Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg|Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.|baseline, 6 weeks|||percent change||Standard Error|Least Squares Mean
116039|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Remission Rate at Week 8|MADRS remission was defined as a MADRS total score < 10 at Week 8. The remission rate is the percentage of subjects in each treatment group who met the criteria for remission. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Participants|||Number
116096|NCT00682786|Post-Hoc|Associations Between MTHFR Diplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
116040|NCT00683592|Secondary|MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate at Week 8|MADRS response was defined as ≥ 50% decrease from baseline in MADRS total score at Week 8. The response rate is the percentage of subjects in each treatment group meeting the criteria for response. The method of last observation carrier forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Participants|||Number
116041|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-A ( Hamilton Anxiety Rating Scale) Total Score|The HAM-A is a rating scale developed to quantify the severity of anxiety. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Change from baseline in the HAM-A total score may range from -52 to 52 with negative value indicating improvement in anxiety symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
116042|NCT00683592|Secondary|The CGI-I (Clinician's Global Impression of Improvement) Score at Week 8|The CGI-I scale measures change from the baseline state at every visit after the baseline visit. It permits a global evaluation of the patient’s improvement over time. At the scheduled clinic visits, the clinician assessed the patient’s improvement relative to the symptoms at baseline on a CGI-I item using a 7-point scale, where 1 = very much improved and 7 = very much worse. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
116043|NCT00683592|Secondary|Change From Baseline to Week 8 in the HAM-D 17 (17-Item Hamilton Rating Scale for Depression) Total Score|The HAM-D 17 is a 17-item subscale of the HAM-D 21, which is designed to be completed by a trained rater. It is designed for rating depressive symptom severity in patients with a confirmed diagnosis of depressive disorder. The change in HAM-D 17 has a possible range of -52 to 52 with negative values indicating improvment in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, week 1, week 2, week 4, week 6, week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
116044|NCT00683592|Primary|Change From Baseline to Week 8 in the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score.|The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.|Baseline, Week 1, Week 2, Week 4, Week 6, Week 8|Intent-to-Treat (ITT): the ITT population consisted of patients who were randomized, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy endpoint measurement.||Units on a scale||95% Confidence Interval|Least Squares Mean
116045|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 30|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.|||||
116046|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 16|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.|||||
116047|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 15|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.|||||
116048|NCT00683475|Secondary|Minimum Concentration (Cmin) at Study Day 1|"Minimum concentration (Cmin) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.|||||
116049|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 30|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 30|Zero participants were analyzed.|||||
116050|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 16|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 16|Zero participants were analyzed.|||||
116051|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 15|"Maximum concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 15|Zero participants were analyzed.|||||
116052|NCT00683475|Secondary|Maximum Concentration (Cmax) at Study Day 1|"Maximum Concentration (Cmax) of Ramucirumab.~All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted."|Day 1|Zero participants were analyzed.|||||
116205|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference|Measuring of weight and waist circumference in centimeter.|4 month|No data were reported as no participants completed the study||centimeters||Standard Deviation|Mean
116053|NCT00683475|Secondary|Objective Response Rate (ORR)|"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100."|Baseline to date of progressive disease or death up to 36.3 months|Participants with measurable disease at baseline, who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
116054|NCT00683475|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive.|First dose to death due to any cause up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. Twelve participants were censored in the IMC-1121B + Mitoxantrone + Prednisone arm"||months||95% Confidence Interval|Median
116055|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 12-months|"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|12 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
116056|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 9-months|"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|9 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
116057|NCT00683475|Secondary|Composite Progression-free Survival (cPFS) at 6-months|"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|6 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
116058|NCT00683475|Secondary|Prostate Specific Antigen (PSA) Response Rate|PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline.|Baseline up to data cut-off date (up to 36.3 months)|Participants who received any quantity of study drug, had baseline PSA value >= 2 ng/ml and at least one non-missing post-baseline PSA.||percentage of participants||95% Confidence Interval|Number
116059|NCT00683475|Secondary|Time to Radiographic Evidence of Disease Progression|"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy."|Randomization to date of radiographic progression, up to 36.3 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~34 participants were censored in IMC-A12 arm and 34 participants were censored in IMC-1121B (ramucirumab) arm."||months||95% Confidence Interval|Median
116060|NCT00683475|Secondary|Summary Listing of Participants Reporting Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Randomization to 36.3 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.||participants|||Number
116061|NCT00683475|Primary|Composite Progression-free Survival (cPFS)|"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy."|Randomization to composite progressive disease, up to 23.4 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~11 participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. 15 participants were censored in the IMC-1121B (ramucirumab) + Mitoxantrone + Prednisone arm."||months||95% Confidence Interval|Median
116062|NCT00683449|Secondary|Hospital Admission Rate During Visit 1|After a patient in the emergency department (ED) presents with an acute exacerbation of asthma, the hospital proceeds with SOC procedures for this condition. Despite treatment in the ED, it is sometimes necessary to admit the patient into the hospital. In the study described here, the rate of hospital admissions was recorded.|Hour -1.5 through Hour 5|||participants|||Number
116064|NCT00683449|Primary|Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo.|The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.|Baseline and Hour 2|The analysis was performed on the Intention-to-Treat (ITT) population. Twenty-nine subjects met the study entry criteria, provided written informed consent, and were enrolled in the study.||FEV1 (percent of predicted)||Full Range|Mean
116065|NCT00683410|Primary|Number of Participants With Spontaneous Adverse Events||30 days post injection up to 3 years|Safety Analysis set - all participants who received at least one dose of Prevenar||Participants|||Number
116066|NCT00683384|Primary|Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection||30 days post injection up to 3 years|Full analysis set||Participants|||Number
116067|NCT00683332|Primary|Number of Participants With Spontaneous Adverse Events|"Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: How have you been feeling since your last visit?"|30 days post injection up to 3 years|Safety Population: All participants who received at least 1 dose of tygacil||Participants|||Number
116068|NCT00683293|Secondary|Complications||up to 2 weeks|||participants|||Number
116069|NCT00683293|Primary|Duration of Surgery|•Mean Time to complete surgery from cut to suture|after surgey|||minutes||Standard Deviation|Mean
116070|NCT00683163|Secondary|Change From Baseline in Trabecular Spine vBMD|Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here.|Baseline, 24 months.|||Percent change from baseline||Standard Deviation|Mean
116071|NCT00683163|Primary|P1NP (ng/ml) Change From Baseline.|After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.|Baseline, 3 months|Analyses were performed according to intention-to-treat principle. A sample size of 20 participants per group was estimated to provide 80% power to detect a change of 25ng/mL in PINP, assuming the SD of 40ng/mL observed previously with concurrent PTH(1-84) and daily alendronate.||Percent change from baseline||95% Confidence Interval|Geometric Mean
116072|NCT00683085|Secondary|Number of Participants With Tumor Regression|Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.|2 months|intension to treat (ITT)||participants|||Number
116073|NCT00683085|Primary|Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events|Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)|2 months|Intention to treat (ITT)||participants|||Number
116074|NCT00683046|Secondary|Median Overall Survival|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years|||Days||95% Confidence Interval|Median
116075|NCT00683046|Primary|Median Disease-free Survival|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"|Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years|||Days||95% Confidence Interval|Median
116076|NCT00683020|Secondary|Changes in Diastolic Blood Pressure (DBP)|Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||mm Hg||Standard Error|Least Squares Mean
116077|NCT00683020|Secondary|Changes in Systolic Blood Pressure (SBP)|Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body. Change is calculated as 6-month pressure minus baseline pressure.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||mm Hg||Standard Error|Least Squares Mean
116092|NCT00682851|Secondary|Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women|Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
116078|NCT00683020|Secondary|Changes in Hemoglobin A1c Levels|Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way. This serves as a marker for average blood glucose levels over the previous months prior to the measurement. Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease. Change is calculated as 6-month level minus baseline level.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||percentage||Standard Error|Least Squares Mean
116079|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Interpersonal Processes of Care (IPC) Scale|The Interpersonal Processes of Care (IPC) is an 18-item patient report instrument that measures patients’ perspectives on the structure of their care and collects patient reports on providers’ communication over the prior 6 months. The scale is intended to measure patients’ assessment of providers’ communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness). Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score. Higher total scores indicate better communication. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
116080|NCT00683020|Secondary|Changes in Patient-centeredness of Care as Measured by Patient Assessment of Chronic Illness Care (PACIC) Scale|The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients’ perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past 6 months that are aligned with the Chronic Care Model. The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support. Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care. Scores are transformed to a 100-point scale (0-100) and averaged across all items to create a total scale score. Higher transformed and total scale scores indicate better care. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
116081|NCT00683020|Secondary|Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale|The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project. The scale is designed to reflect patients’ assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care). Respondents are asked how difficult over the past 6 months has it been to follow exactly as their doctor who takes care of their diabetes suggested. Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy. Total scale score is calculated as the average across all items. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
116082|NCT00683020|Secondary|Changes in Self-reported Medication Adherence as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure’s author’s recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
116083|NCT00683020|Secondary|Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale|The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors. The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence. Based on SDSCA measure’s author’s recommendations, two separate scores are derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score. For the Diabetes Self-management Behaviors score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged. For the Self-reported Medication Adherence score, all items pertaining to medication use are averaged. For both scores, the result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior or better medication adherence. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
117161|NCT00672555|Secondary|Reoperations Needed for Treatment of Complication|"All patients were seen at the outpatients clinic at 3 weeks. Follow-up control was initiated at 1 year.~All reoperations that were done were assessed and measured."|1year|||Reoperations|||Number
116084|NCT00683020|Secondary|Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities|A measure of diabetes interference on patients is ascertained by asking patients the following question: “In the last 6 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?” Responses consist of 6 possible options: “Always”, “Almost Always”, “Often”, “Sometimes”, “Almost Never”, and “Never”. These responses are grouped into 2 categories, with one category consisting of “Always”, “Almost Always”, and “Often” responses while the other category consists of the remaining responses. The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||proportion of patients|||Number
116085|NCT00683020|Secondary|Number of Days Spent in Bed Due to Illness|A measure of patients’ functional status is ascertained by asking patients the following question: “In the last 30 days, how many days did health problems keep you in bed for all or most of the day?” Number of days may range from 0 to 30, with lower number of days indicating better functional status. Because a negative binomial model was used to analyze the data for number of days spent in bed due to illness, log means are reported. A log mean is the natural (base e) logarithm of the mean (in this context specifically, the mean number of days spent in bed due to illness). To calculate the mean, one raises e by the number given as the log mean. Lower log means indicate better functional status.|6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||log days||95% Confidence Interval|Mean
116086|NCT00683020|Primary|Changes in the Mental Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
116087|NCT00683020|Primary|Changes in the Physical Component Summary of the SF-12 Health Survey|The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome. Change is calculated as 6-month score minus baseline score.|Baseline and 6 months|The Participant Flow Module numbers are the numbers of participants in the particular categories of the module. However, the number of participants analyzed counts only those participants who have both baseline and 6-month follow-up outcome data.||units on a scale||Standard Error|Least Squares Mean
116088|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790–800) and is reported with units min-1/(µlU/L).|baseline and 3 months|||min-1/(µlU/L)||Standard Deviation|Mean
116089|NCT00682890|Primary|Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)|Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790–800) and is reported with units min-1/(µlU/L).|baseline and 3 months|||units on a scale||Standard Deviation|Mean
116090|NCT00682851|Secondary|Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.|Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
116091|NCT00682851|Secondary|Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.|Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.|Visit 1|||Percentage of Participants||95% Confidence Interval|Number
120839|NCT00636194|Primary|Subjective Assessment of Comfort and Cleanliness|Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.|7 days|All eyes||Scores on a scale|Participants|Standard Deviation|Mean
116098|NCT00682786|Post-Hoc|Associations Between MTHFR Haplotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
116099|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
116100|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
116101|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Poor Risk Group)|Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.|First day of treatment through 30 days after completion of surgery|2 of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
116102|NCT00682786|Post-Hoc|Associations Between MTHFR Genotypes and Grade 3-4 Diarrhea and/or Mucositis (Good Risk Group)|"Genomic DNA was isolated from whole blood using the Puregene DNA isolation kit.~MTHFR gene = methylenetetrahydrofolate reductase (NAD(P)H)"|First day of treatment through 30 days after completion of surgery|2 of the patients in the Good Risk arm withdrew consent and are not included.||participants|||Number
116103|NCT00682786|Post-Hoc|Relapse-free Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|"14 patients in the Good Risk arm had metastatic rectal cancer at time of enrollment are not included in this analyses.~3 patients in the Poor Risk arm had metastatic rectal disease before surgery and are included in this analyses.~2 of the patients in the Good Risk arm and Poork Risk arm withdrew consent and are not included."||percentage of participants|||Number
116104|NCT00682786|Post-Hoc|Overall Survival|Analyzed using Kaplan-Meier Models.|1 year, 2 years, and 3 years|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.||percentage of participants|||Number
116105|NCT00682786|Post-Hoc|Toxicities by Genotype Group (Good Risk Versus Poor Risk)|Grade 3 to 4 toxicities related to treatment and surgery using CTC Version 2.0.|First day of treatment through 30 days after completion of surgery|Two of the patients in the Good Risk arm withdrew consent and are not included. Two of the patients in the Poor Risk arm withdrew consent and are not included.||participants|||Number
116106|NCT00682786|Secondary|Determine Patient Fears and Expectations of Pharmacogenetics.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy||||||
116107|NCT00682786|Secondary|Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.|The questionnaire is encouraged but not required.|Prior to start of study treatment and 3-6 weeks post completion of radiation therapy||||||
116108|NCT00682786|Secondary|Complete Response Rates|"Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0).~Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0).~pCR rate of historical controls is 8%-14%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"||percentage of participants|||Number
116109|NCT00682786|Primary|Rate of Tumor Downstaging Compared With Historical Controls.|"Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1.~Historical studies demonstrate a DS rate of 45%."|1 year after enrollment|"8 not evaluable in Good Risk arm-(1)death before surgery (1)clinical CR w/o surgery (1)refused surgery (2)not resectable (2)withdrew consent (1)delayed surgery and given FOLFOX~6 not evaluable in Poor Risk arm-(1) death prior to surgery (1)clinical CR no surgery (1)refused surgery (2)withdrew consent (1)not given irinotecan by treating physician"||percentage of participants||95% Confidence Interval|Number
116110|NCT00682734|Primary|Pain Intensity Score|Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.|Baseline, 60 minutes|per protocol||scores on a scale||Standard Deviation|Mean
116111|NCT00682643|Secondary|Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods|rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).|Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104|ITT Population||scores on a scale||Standard Error|Least Squares Mean
116112|NCT00682643|Secondary|Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104|"The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the cup portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology."|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||percent change||Standard Deviation|Mean
116155|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116113|NCT00682643|Secondary|Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104|ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the [decadic] logarithm of the minimum angle of resolution [range from +1.00 to -0.30]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
116114|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline in IOP was calculated by subtracting the baseline value from the Week 104 value.|Baseline and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
116115|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.|Baseline and Week 52|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
116116|NCT00682643|Secondary|Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||mm Hg||Standard Deviation|Mean
116117|NCT00682643|Secondary|Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104|Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
116118|NCT00682643|Secondary|Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104|Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
116119|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
116120|NCT00682643|Secondary|Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104|An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
116121|NCT00682643|Secondary|Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104|An event for P is defined as an increase of >=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||participants|||Number
116122|NCT00682643|Secondary|Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.|Baseline, Week 52, and Week 104|ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.||scores on a scale||Standard Deviation|Mean
117346|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
116123|NCT00682643|Primary|Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event|An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants with post-baseline ophthalmic examination data were included in the analysis for this endpoint.||percentage of participants|||Number
116124|NCT00682643|Primary|Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)|An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of >=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 [lens clear] to 5.9 [lens unclear]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.|Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104|ITT Population. All participants (par.) with post-baseline ophthalmic examination data were included in the analysis for this endpoint. Par. without post-baseline ophthalmic exam data were censored at the randomization data. Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.||Percentage of participants|||Number
116125|NCT00682565|Secondary|Participants With 1 mm ST Segment Depression During ETT-3|ST Segment Depression measured by Electrocardiography while performing ETT-3.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3. However, majority of patients did not have ECGs assessable (per protocol) for 1 mm ST depression.||Participants|||Number
116126|NCT00682565|Secondary|Participants Stopping ETT-3 for Angina at Any Stage|"This Outcome Measure includes all participants who stopped ETT-3 for angina at any stage, not only those who stopped at a stage earlier than ETT-B.~Note: All 9 subjects who stopped ETT-3 for angina also stopped ETT-B for angina."|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||Participants|||Number
116127|NCT00682565|Secondary|Change in Exercise Duration During ETT-3 vs. ETT-B||1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||seconds||Standard Deviation|Mean
116128|NCT00682565|Secondary|Participants Stopping ETT-3 for Any Reason at Stage Earlier Than ETT-B|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||Participants|||Number
116129|NCT00682565|Primary|Participants Stopping Exercise Treadmill Test 3 (ETT-3) for Angina at Stage Earlier Than Baseline Exercise Treadmill Test (ETT-B)|The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.|1 day|The Safety ETT Population consists of all patients in the Randomized Population who received any study drug and who performed ETT-3.||Participants|||Number
116130|NCT00682539|Secondary|To Explore the Structural Mechanisms of the Effect on Diabetic Macular Edema as Assessed by Fluorescein Angiography and Ultra High-resolution Optical Coherence Tomography. To Observe the Changes in Retinal Function a Microperimetry is Assessed.|Area of leakage and non perfusion is measured in FA, morphologic details like presence of cysts or sub retinal fluid is evaluated in OCT. Data is still under evaluation.|12 month||06/2016||||
116131|NCT00682539|Primary|Efficacy of the Treatment Assessed by Standard Optical Coherence Tomography (OCT)|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is measured with standard Optical Coherence Tomography - (OCT): units: µm; scale range: 200-800; higher values are considered worse outcome|12 months|||µm||Standard Deviation|Mean
116132|NCT00682539|Primary|Efficacy of the Treatment Assessed With Visual Acuity Measured by ETDRS Charts.|Efficacy of the treatment with intravitreal administered injections of anti VEGF (Bevacizumab (Avastin®) or Ranibizumab (Lucentis®) ) compared with triamcinolone (Volon A®) in patients with diabetic macular edema is examined using Visual acuity measurements with ETDRS charts: units: logMAR; scale range: -0.1 to 1.0; higher values are considered worse outcome|12 month|||logMAR||Standard Deviation|Mean
116133|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
116134|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 12|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
116135|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 6|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
116136|NCT00682461|Secondary|Percentage of Participants With Adverse Events|"Adverse Event=any untoward medical occurrence in a subject following administration of an investigational product, which did not necessarily have a causal relationship with this treatment.~Serious Adverse Event=any untoward medical occurrence that at any dose; results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect"|From baseline to Week 14|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
116137|NCT00682461|Primary|Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1|Oral Soft Tissue related adverse events= Any abnormality occuring in any of these: labial mucosa (including lips), gingival mucosa, buccal mucosa, mucogingival folds, hard and soft palates, tonsilar and pharyngeal areas, tongue, sublingual and submandibular areas, and salivary glands|From baseline to Week 1|Analysis was based on safety population, which consisted of all randomized participants who took at least one dose of the study medication.||Percentage|||Number
116138|NCT00682357|Secondary|Change in Serum Cortisol|Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.|Change from Baseline Visit to Day 28|||mcg/dL||Standard Deviation|Mean
116139|NCT00682357|Secondary|Change in Testosterone|Outcome represents the mean change in testosterone level from baseline visit to day 28.|Change from Baseline Visit to Day 28|Only males randomized to Group 1 - Standard Dose were included in this analysis.||ng/dL||Standard Deviation|Mean
116140|NCT00682357|Primary|Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)|Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.|Change from Baseline Visit to Day 28|||U/L||Standard Deviation|Mean
116141|NCT00682357|Primary|Change in Serum Osteocalcin|Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.|Change from Baseline Visit to Day 28|||ng/mL||Standard Deviation|Mean
116142|NCT00681889|Secondary|Efficacy by Measuring Mean Change of BCVA||Prospective||||||
116143|NCT00681889|Secondary|Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs||Prospective||||||
116144|NCT00681889|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||16 Weeks||||||
116145|NCT00681889|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing|16 Weeks|All participants enrolled into the study were analyzed.||participants|||Number
116146|NCT00681863|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters|Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)|Baseline and 24 weeks|Observed Cases Treated set (OC TS). All participants in Treated Set having observed data at the particular timepoint.||participants|||Number
116147|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||participants|||Number
116148|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 20|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116149|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116150|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116151|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116152|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116153|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116154|NCT00681863|Secondary|Patient Global Impression - Improvement|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.|||||
117746|NCT00666848|Primary|Change in MAP During Placebo|The change in mean arterial pressure (MAP) in response to placebo or enalapril after pretreatment with 5 days of placebo|just prior to drug administration and 8 hours after drug administration|||mmHg||Standard Deviation|Mean
116158|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 16|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116159|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 12|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116160|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 8|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116161|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 4|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116162|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 3|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116163|NCT00681863|Primary|Patients With Adverse Events Leading to Discontinuation of Trial Drug|Number of patients with Adverse Events leading to discontinuation of trial drug|24 Weeks|Treated set||participants|||Number
116164|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 2|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116165|NCT00681863|Secondary|Clinical Global Impressions - Improvement|Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).|week 1|This outcome measure was not analyzed due to the premature ending of the trial.|||||
116166|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness, Categorized|"Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients).~Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement."|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||participants|||Number
116167|NCT00681863|Secondary|Clinical Global Impressions - Severity of Illness|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||score on a scale||Standard Deviation|Mean
116168|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116169|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116170|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116171|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116172|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116173|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116174|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116175|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116176|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116177|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 24|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116178|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 20|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116179|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 16|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116180|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 12|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116181|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 8|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116182|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 4|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116183|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 3|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116184|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 2|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116185|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and Week 1|Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.||Score on a scale||Standard Deviation|Mean
116186|NCT00681863|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe).|baseline and Week 24 (end of treatment visit)|The Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).||Score on a scale||Standard Deviation|Mean
116187|NCT00681863|Secondary|Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.|baseline and week 24|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||Score on a scale||Standard Deviation|Mean
116188|NCT00681824|Secondary|Number of Participants With Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||participants|||Number
116189|NCT00681824|Secondary|Incidence of Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria||within 1 month following surgery|"Primary Safety Data Set~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||percentage of participants||95% Confidence Interval|Number
116190|NCT00681824|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2–transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2–transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"||participants|||Number
116206|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication|Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.|4 month|No data were reported as no participants completed the study||Drugs||Standard Deviation|Mean
116191|NCT00681824|Secondary|Number of Participants With Procedures Resulting From the Treatment of CSF Leaks|The number of participants with surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures.|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||participants|||Number
116192|NCT00681824|Secondary|Incidence of Procedures Resulting From the Treatment of CSF Leaks|The incidence of surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures|until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~One participant (FS VH S/D 500 s-apr arm) removed from analysis due to subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy"||percentage of participants||95% Confidence Interval|Number
116193|NCT00681824|Primary|Incidence of Cerebrospinal Fluid (CSF) Leakage Observed After Surgery|"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage."|33 +/- 3 days after surgery|"Intent to treat~One participant (SoC arm) received products other than FS VH S/D 500 s-apr for sealing of dura sutures and was removed from analysis~Two participants (FS VH S/D 500 s-apr arm) removed from analysis due to (1) subsequent surgery unrelated to CSF leakage/surgical site infection that involved re-durotomy (2) withdrew from study"||percentage of participants||95% Confidence Interval|Number
116194|NCT00681811|Primary|Days of Exposure to HGT-1111|End of study was defined as until HGT-1111 was commercially available, the participant’s participation was discontinued, or the study was terminated by the Sponsor.|Baseline until end of study (Week 139)|Safety population was defined as all enrolled participants who received at least one study infusion (or any portion of a dose) of HGT-1111.||Days||Standard Deviation|Mean
116195|NCT00681811|Secondary|Score of Gross Motor Function Measurement (GMFM)|Gross motor function was measured using GMFM-88 at 6-month intervals. The GMFM-88 item scores were summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) to 264 (maximum). Decrease in GMFM score indicates disease progression.|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."||scores on a scale||Standard Deviation|Mean
116196|NCT00681811|Secondary|Level of White Matter Metabolites|Level of white matter metabolites [N-acetyl Aspartate (NAA)] measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure. No participants were analysed after Month 18, hence, data were not available after Month 18."||nmol/L||Standard Deviation|Mean
116197|NCT00681811|Secondary|Level of Cerebrospinal Fluid (CSF) Sulfatide|Level of CSF sulfatide measured at 6-month intervals in HGT-MLD-049 (NCT00681811).|Baseline until end of study (Week 139)|"Safety population. Number of participants analysed signifies participants who were evaluable for the respective arms under this outcome measure."||nanomole per liter (nmol/L)||Standard Deviation|Mean
116198|NCT00681668|Secondary|Electrocardiogram (ECG), Vital Signs, Laboratory|"Safety parameter:s electrocardiogram (ECG), vital signs, laboratory~no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated||participants|||Number
116199|NCT00681668|Secondary|Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)|Change in functional outcome: Global Assessment of Functioning (GAF),scale of 1-100 (1 = severe symptoms - 100 = no symptoms) Parental bonding Questionnaire (PBQ) no participants analysed - terminated study|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated||scores on a scale||Full Range|Median
116200|NCT00681668|Secondary|Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)|"Change in efficacy scales: Clinical Global Impression (CGI),Scale of 1-7 (1 = normal or no change - 7 = extremely ill or extreme changes).~Montgomery Asberg Depression Rating scale (MADRS) 10 questions with a scale of 1-4 (1 = no symptoms - 4 = severe symptoms), higher score = worst values.~Brief Psychiatric rating scale (BPRS)- 24 symptom constructs, each to be rated in a 7-point scale of severity ranging from 'not present' to 'extremely severe' no participants analysed - terminated study"|Baseline Day 1 to final visit 28 weeks|Data not analyzed, study terminated||Units on a scale||Full Range|Mean
116201|NCT00681668|Primary|The Change in the Hamilton Rating Scale for Depression (HAM-D)|HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state|Baseline Day 1 to final visit 28 weeks|||scores on a HAM-D scale||Full Range|Mean
116202|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events|Listing of all adverse event or SAE´s to show the safety and tolerability.|4 month|No data were reported as no participants completed the study||number of events|||Number
116203|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Concomitant Medication|Listing of all concomitant medication to show the efficacy and safety.|4 month|No data were reported as no participants completed the study||Name of concomitant medication|||Number
116204|NCT00681629|Secondary|Evaluate Safety and Tolerability by Evaluation of Laboratory Tests|Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.|4 month|No data were reported as no participants completed the study||depending on the Lab test (see above)||Full Range|Mean
116207|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities|The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.|4 month|No data were reported as no participants completed the study||days||Standard Deviation|Mean
116208|NCT00681629|Secondary|Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization|Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.|4 month|No data were reported as no participants completed the study||days||Standard Deviation|Mean
116209|NCT00681629|Secondary|Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)|"The 'CSQ-8 is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116210|NCT00681629|Secondary|Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)|The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.|4 month|No data were reported as no participants completed the study||Participants|||Number
116211|NCT00681629|Secondary|Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)|"The 'SES is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116212|NCT00681629|Secondary|Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale|"The '(RSM is a new 36-item measure validated to assess the QoL in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher QoL."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116213|NCT00681629|Secondary|Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire|Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116214|NCT00681629|Secondary|"Vocational Occupational Index VOC Score"|The “VOC” index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment|Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116215|NCT00681629|Secondary|EQ-5D (European Quality of Life Questionnaire) Score|"The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression).~The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of severity- no problems, some problems and extreme problems. Higher scores indicate more problems."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116216|NCT00681629|Secondary|PSP (Personal and Social Performance) Scale Score|"The '(PSP rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116217|NCT00681629|Secondary|GAF (Global Assessment of Functioning) Scale Score|"The GAF is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance."|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116218|NCT00681629|Secondary|Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score|The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116219|NCT00681629|Secondary|Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale|With the CGI-S the rate of the severity of a patient’s symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116220|NCT00681629|Secondary|Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 month|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116221|NCT00681629|Primary|Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale|The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.|4 months|No data were reported as no participants completed the study||Scores on a scale||Standard Deviation|Mean
116222|NCT00681590|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D Levels||baseline and 6 months|||ng/ml||Standard Deviation|Mean
116223|NCT00681590|Primary|Number of Participants Who Develop Hypercalcemia|calcium serum levels measured at baseline and at the end of the intervention (6-months)|6 months|||participants|||Number
116224|NCT00681564|Secondary|Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
116225|NCT00681564|Secondary|Matrix Metalloproteinase-9 (MMP-9)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
116226|NCT00681564|Secondary|Myeloperoxidase (MPO)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
116227|NCT00681564|Secondary|Vascular Cell Adhesion Molecule 1 (VCAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
116228|NCT00681564|Secondary|Intercellular Adhesion Molecule 1 (ICAM-1)||12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
116229|NCT00681564|Secondary|Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)|"Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®).~Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis."|12 weeks post periodontal therapy|Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.||ng/ml||Standard Deviation|Mean
116230|NCT00681564|Secondary|LDL Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||mg/dL||Standard Deviation|Mean
116231|NCT00681564|Secondary|Subgingival Microbiota|Polymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).|12 weeks post-periodontal therapy|||participants|||Number
116232|NCT00681564|Secondary|White Blood Cell Count||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||cells/mm^3||Standard Deviation|Mean
116233|NCT00681564|Secondary|Total Cholesterol||Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||mg/dL||Standard Deviation|Mean
116234|NCT00681564|Secondary|High-sensitivity C-Reactive Protein|The fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|||mg/L||Standard Deviation|Mean
116235|NCT00681564|Primary|Brachial Artery Flow-mediated Dilation|All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).|Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy|The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables.||Percentage of dilatation of brachial art||Standard Deviation|Mean
116236|NCT00681538|Secondary|Mood Assessment: Change in Beck Depression Inventory - II (BDI-II)From Baseline to End of Treatment (Phase B)|This was a 21-question multiple choice self-report inventory. Subjects’ responses to the 21 questions were assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. An decrease in score indicates an improvement in condition.|Baseline (End of week 4) - end of treatment (end of week 17)|||Score on scale||Standard Deviation|Mean
116237|NCT00681538|Secondary|Change EuroQoL Quality of Life Questionnaire (EQ-5D)From Baseline to End of Treatment (Phase B)|"The EQ-5D questionnaire provided two outcomes:~A weighted health state index visual analogue scale (VAS)~A self-rated health status VAS EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.~The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing."|[Baseline (End of Week 4) - End of treatment (End of Week 17)|EQ-5D Health State Index Sativex n=117 and placebo n=111. EQ-5D Health Status VAS Sativex n=121 and placebo n=117.||score on scale||Standard Deviation|Mean
116238|NCT00681538|Secondary|Physician Global Impressions of Change at End of Treatment (Phase B).||End of treatment (week 17)|||participants|||Number
116242|NCT00681538|Secondary|Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B).|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Baseline (End of Week 4) - End of treatment (End of Week 17)|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk.||Seconds||Standard Deviation|Mean
116243|NCT00681538|Secondary|Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. Leg - 3 movements were ankle dorsiflexion, knee extension and hip flexion. The total arm and leg score was the addition of the score for the 3 arm movements and 3 leg movements, respectively. One point was then added to each limb score to give a maximum score of 100; minimum was 1 point. Where both arms (or both legs) were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)|For Arm subject numbers were 23 for Sativex and 22 for placebo. For Leg subject numbers were 91 for Sativex and 92 for placebo.||Score on scale||Standard Deviation|Mean
116244|NCT00681538|Secondary|Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B).|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Baseline (End of Week 4) - End of treatment (End of Week 17)|||Score on scale||Standard Deviation|Mean
116245|NCT00681538|Secondary|Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B).|The sleep disruption NRS score was recorded by subjects via a daily call to the interactive voice response system at bedtime. Subjects were asked “On a scale of ‘0 to 10’ please indicate how you your spasticity disrupted your sleep last night” with the anchors: 0 = ‘did not disrupt sleep’ and 10 = ‘completely disrupted (unable to sleep at all)'.|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)|||Points on scale||Standard Deviation|Mean
116246|NCT00681538|Secondary|Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B).|The subjects’ baseline spasm frequency was the mean of the last seven days scores (Week 4) of Phase A treatment. The variable for analysis was the change in mean spasm frequency from baseline to the end of treatment (last 7 days of Week 17 Phase B).|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)|||Spasms per day||Standard Deviation|Mean
116247|NCT00681538|Secondary|Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.|A subject was classified as a responder in the evaluable period provided they did not withdraw due to lack of efficacy and achieved at least a 30% or 50% reduction (i.e. improvement) in the mean NRS spasticity score from baseline (Day 1) to the end of treatment(last 7 days of Week 17 Phase B). All other subjects and subjects without evaluable data were considered non-responders.|Baseline (Day 1) - End of treatment (last 7 days of Week 17)|||participants|||Number
116248|NCT00681538|Primary|The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).|Subjects were asked “On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. They were asked to relate ‘no spasticity’ to the time prior to the onset of their spasticity.|Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)|||Points on scale||Standard Deviation|Mean
116249|NCT00681473|Secondary|Percentage of Participants With Overall Survival|Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years|||% of participants|||Number
116250|NCT00681473|Secondary|Percentage of Participants With Progression Free Survival|Clinical and/or radiographic assessments Percentages were estimated by Kaplan Meier|At 1, 3, and 5 years|||% of participants|||Number
116251|NCT00681473|Primary|Number of Participants With Late Effects > 3 Months Post RT||5 years|||Participants|||Count of Participants
116252|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 24 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 24 Months|Of the 88 participants in Arm 1 who started the study, 75 completed the Activities Assessment Scale at 24 months. Of the 84 participants in Arm 2 who started the study, 57 completed the Activities Assessment Scale at 24 months.||units on a scale||Standard Deviation|Mean
116253|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 12 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 12 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 12 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 12 months.||units on a scale||Standard Deviation|Mean
116254|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 6 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 6 Months|Of the 88 participants in Arm 1 who started the study, 83 completed the Activities Assessment Scale at 6 months. Of the 84 participants in Arm 2 who started the study, 70 completed the Activities Assessment Scale at 6 months.||units on a scale||Standard Deviation|Mean
116255|NCT00681291|Primary|Change From Baseline in Activities Assessment Scale at 3 Months|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty = 1” to “Not able to do it = 5.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity. Subjects completed the assessment at baseline, 3 months, 6 months, 12 months and 24 months. It is the change from baseline to 3, 6, 12 and 24 months which is the primary outcome measure (Baseline calculated value minus time point calculated value). Therefore, a negative number indicates an increase in activity from baseline.|Baseline to 3 Months|Of the 88 participants in Arm 1 who started the study, 81 completed the Activities Assessment Scale at 3 months. Of the 84 participants in Arm 2 who started the study, 77 completed the Activities Assessment Scale at 3 months.||units on a scale||Standard Deviation|Mean
116256|NCT00681265|Secondary|Fluorescein Tear Film Break-up Time|Standard clinical assessment methodology for assessing tear stability.|120 minutes after eye drops instillation|Study N determined empirically by PI.||seconds||Standard Deviation|Mean
116257|NCT00681265|Primary|Noninvasive Tear Film Break-up Time|State-of-the-art methodology to assess tear stability.|15 minutes after eye drop instillation|Study N determined empirically by PI.||seconds||Standard Deviation|Mean
116258|NCT00681187|Secondary|Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method|"Assessed by the number of HCP with a positive response 'yes' to two questions:~Based on your experience during this trial, did you feel confident in the safety of your patients?~Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?"|Between week 30 to 34|One HCP from each site who enrolled participants replied to the question||participants|||Number
116259|NCT00681187|Secondary|5-hydroxyindoleacetic Acid (5-HIAA) Levels|"Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.~'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.~'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.~'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.~'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|5-HIAA were assessed as judged necessary by the investigator at each site.||nmol/l||Standard Deviation|Mean
116260|NCT00681187|Secondary|Chromogranin A Levels|"Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.~'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.~'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.~'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.~'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2."|Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.|ITT population that had hormone levels assessed at each administration block.||nmol/l||Standard Deviation|Mean
116261|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea|Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.||participants|||Number
116262|NCT00681187|Secondary|Perceived Symptom Control Evaluation in Respect to Episodes of Flushing|Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.|Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.||participants|||Number
116263|NCT00681187|Secondary|Total Number of Visits to HCP Due to Carcinoid Symptoms|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication||visits|||Number
120865|NCT00635882|Primary|Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline to Day 14|All Randomized Participants||percentage of eNO||Standard Deviation|Mean
116264|NCT00681187|Secondary|Days Sick Leave|Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).|Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)|Safety population: all randomised subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.||days|||Number
116265|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing|The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded||participants|||Number
116266|NCT00681187|Secondary|Number of Patients Stating at Least One Injection Interfered With Daily Activities|The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'|Between baseline to week 32, after each injection (8-9 injections)|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded||Participants|||Number
116267|NCT00681187|Primary|Subject Preference for Self or Partner Administration|A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection|Between week 30 to 34|Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded||participants|||Number
116268|NCT00681109|Secondary|Occurrence of Adverse Events||16 Weeks||||||
116269|NCT00681109|Primary|Schirmer With Anesthesia||16 Weeks||||||
116270|NCT00681109|Primary|Schirmer Without Anesthesia||16 Weeks||||||
116271|NCT00681109|Primary|Meibomian Gland Occlusion||16 Weeks||||||
116272|NCT00681109|Primary|Ocular Surface Disease Index (OSDI)|"The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4].~Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning.~OSDI was assessed on the Screening Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Screening to Week 12."|16 Weeks|The OSDI analysis for this study is based on a standard intention-to-treat analysis with each study participant analyzed with respect to the randomized treatment assignment, regardless of eventual compliance.||units on a scale||95% Confidence Interval|Mean
116273|NCT00681109|Primary|Conjunctival Staining Score||16 Weeks||||||
116274|NCT00681109|Primary|Cornea Staining Score||16 Weeks||||||
116275|NCT00681109|Primary|Tear Breakup Time (TBUT)||16 Weeks||||||
116276|NCT00681109|Primary|Meibomian Gland Secretion Quality||16 Weeks||||||
116277|NCT00680953|Secondary|Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.|The results are expressed as a percentage by Kaplan-Meier estimate.|Baseline to 24 Months|||percentage of participants|||Number
116278|NCT00680953|Secondary|The Percentage of Non-vertebral Fractures|The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures|Baseline to 24 Months|||percentage of participants||95% Confidence Interval|Number
116279|NCT00680953|Primary|Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo||Baseline to 24 months|||Vertebral fractures||95% Confidence Interval|Mean
116280|NCT00680914|Secondary|Number of Subjects With Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
116281|NCT00680914|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||Within 31 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
116282|NCT00680914|Secondary|Number of Subjects With Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.~Fever was defined as axillary temperature >= 37.5 degrees Celsius."|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
116283|NCT00680914|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
116284|NCT00680914|Secondary|Number of Subjects With Seroprotection Status Against PRP|Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
116285|NCT00680914|Secondary|Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentration of anti-PRP antibody given as GMC in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||ug/mL||95% Confidence Interval|Geometric Mean
116286|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes|The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
116287|NCT00680914|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||ug/mL||95% Confidence Interval|Geometric Mean
116288|NCT00680914|Secondary|Anti-PD Antibody Concentration|Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.|One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||EL.U/mL||95% Confidence Interval|Geometric Mean
116289|NCT00680914|Secondary|Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine|Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||ug/mL||95% Confidence Interval|Geometric Mean
116290|NCT00680914|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).~Pneumococcal cross-reactive serotypes were 6A and 19A."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
116291|NCT00680914|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value|"The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8.~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
116292|NCT00680914|Secondary|Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes|"Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations >= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL.~Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.05 ug/mL."|One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
116293|NCT00680914|Primary|Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after administration of 3rd dose of the pneumococcal conjugate vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
116294|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for indicated hematology parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Hematology parameter included: Hemoglobin (Hemo), Total Neutrophils (TN) Absolute, Platelet Count (PC), and White Blood Cell (WBC) Count.|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
116295|NCT00680901|Secondary|Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters|Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for the indicated clinical chemistry parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transeferase (AST), Total Bilirubin (TB), Calcium (Hypercalcemia and Hypocalcemia), Creatine Kinase (CK), Creatinine, Glucose (Hyperglycemia [high] and Hypoglycemia [low]), Potassium (Hyperkalemia [high] and Hypokalemia [low]), Magnesium (Hypermagnesemia [high] and Hypomagnesemia [low]), and Sodium (Hypernatremia [high] and Hyponatremia [low]).|From Baseline (Day 1) until 28 days after the last dose (average of 239 days)|"Safety Population. Different participants may have been assessed for different parameters; thus the number of participants analyzed reflects everyone in the Safety Population. The number of participants assessed for each parameter is indicated by n=X, X."||Participants|||Number
116302|NCT00680901|Secondary|Time to Response (TTR)|TTR is defined as the time from randomization until the date of the first documented evidence of CR (the disappearance if all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking a reference the Baseline sum LD) as assessed by the investigator.|From Baseline (Day 1) until the first documented evidence of confirmed CR or PR (average of 9 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
116618|NCT00677820|Primary|Number of Subjects Reporting Fever|Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.|Days 0-7|Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
116296|NCT00680901|Secondary|Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36|The EQ-5D is a generic preference-based HROOL self administered tool comprising of a 5-dimensional health status measure (5D utility measure) and a visual analog rating scale feeling thermometer (T.). 5D utility measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. T. assesses participant’s current health state. Each 5D utility question was responded to on a 3-point scale, indicating the level of impairment (1=no problem; 2=some or moderate problem(s); 3=unable, or extreme problems). The index utility values corresponding to the 243 health states were defined by the EuroQol classification and calculated based on country-specific regression coefficients. In the UK-based value set, the possible EQ-5D index utility values range from –0.594 to 1. The T. value ranges from 0 to 100. EQ-5D utility index score 0=death, 1=perfect health, -0.594 = worse than death. The T. score: 100=best imaginable health state, 0=worse imaginable health state.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
116297|NCT00680901|Secondary|Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36|The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
116298|NCT00680901|Secondary|Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36|The QLQ-C30, a self administered tool used to assess HROL, consists of 30 items that assesses 15 domains consisting of 5 functional scales (s.) (physical, role, emotional, cognitive, social) and nine symptom s. or single items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status or QOL s.. For the functional s. and symptom s. or single items, participants assessed using a 4-point s. (1=not at all; 2=a little; 3=quite a bit; 4=very much), whereas global health status or QOL was assessed using a 7-item Likert s., ranging from “poor” to “excellent.” All s. and single-item scores ranged from 0 to 100. For the functional scores, a higher score indicated a better HRQOL, i.e. 0=worst HRQOL, 100=best HRQOL; for the symptom s. or single items , a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.|From Baseline (Day1) to Week 36|Primary Efficacy Population. Only those participants contributing data at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
116299|NCT00680901|Secondary|Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to NCI CTCAE, version 3.0: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population||Participants|||Number
116300|NCT00680901|Secondary|Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication until 30 days after the last dose (average of 229 days)|Safety Population: all randomized participants who received at least one dose of study medication||Participants|||Number
116301|NCT00680901|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of a CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) until the first documented sign of PD or death due to any cause. Per RECIST, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause (average of 36 weeks)|Primary Efficacy Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.||Months||95% Confidence Interval|Median
116318|NCT00680745|Secondary|Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2|To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with baseline BMI of 27 kg/m2 or more and Week 24 (LOCF) body weight value||kg||95% Confidence Interval|Least Squares Mean
116303|NCT00680901|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started) as assessed by the investigator.|From randomization until disease progression (PD) or death due to any cause (average of 30 weeks)|Primary Efficacy Population||Participants|||Number
116304|NCT00680901|Secondary|Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR)|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations).|From randomization until the date of the first documented response of CR or PR (average of 9 weeks)|Primary Efficacy Population||Participants|||Number
116305|NCT00680901|Secondary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From randomization until the earliest date of disease progression or death due to any cause (average of 30 weeks)|Primary Efficacy Population||months||95% Confidence Interval|Median
116306|NCT00680901|Primary|Overall Survival in All Randomized Participants|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment, regardless of whether they actually received study medication.||months||95% Confidence Interval|Median
116307|NCT00680901|Primary|Overall Survival|Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.|From randomization until death due to any cause (average of 51 weeks)|Primary Efficacy Population: all randomized participants with Human Epidermal Growth Factor Receptor 2 (ErbB2)-positive tumors (based on Fluorescence In Situ Hybridization [FISH]-positive designated central laboratory assessment).||months||95% Confidence Interval|Median
116308|NCT00680862|Primary|Number of Participants Who Completed the Survey|survey responses from participants on thoughts pertaining to implementation of HIV rapid testing|6 months|||participants|||Number
116309|NCT00680836|Secondary|Change in Bloating|Bloating is measured on a scale from 0 to 4; 0 = no bloating to 4 = severe bloating. Change in bloating is calculated from baseline to post treatment.|2 weeks|||units on a scale||95% Confidence Interval|Mean
116310|NCT00680836|Secondary|Change in Abdominal Pain With Bowel Movement|Severity of abdominal pain on a scale of 0 to 4 was measured; 0 meaning no pain to 4 meaning severe pain. Change in abdominal pain from baseline to post treatment was calculated.|2 weeks|||units on a scale||95% Confidence Interval|Mean
116311|NCT00680836|Secondary|Change in Bowel Urgency|Urgency in a bowel movements compared from baseline to post treatment was measured. Participants were asked to note if they had urgency at bowel movements (meaning if they had to rush to the restroom). They marked either 'yes' or 'no'. The percentage of the time they said yes was calculated for 7 days. The difference between baseline and post treatment urgency was calculated.|2 weeks|||difference in percentage of 'Yes'||95% Confidence Interval|Mean
116312|NCT00680836|Secondary|Change in Stool Consistency|Change in Stool consistency from baseline to post treatment is measured. Bristol stool scale is used for this purpose. The scale ranges from a value of 1- 7; 1 being very hard stool to 7 being liquid stools. The change is measured for 1 week post-treatment and the average consistency is used for the purpose of measuring change from baseline.|2 weeks|||units on a scale (BSS)||95% Confidence Interval|Mean
116313|NCT00680836|Secondary|Change in Stool Frequency (Number of Bowel Movements Per Day)|Change in stool frequency (number of bowel movements per day) compared from baseline to post treatment is measured. Number of bowel movements per day before treatment is subtracted from the number of bowel movements per day after treatment. The change in frequency has been reported in the outcomes table.|2 weeks|||Bowel movements/ day||95% Confidence Interval|Mean
116314|NCT00680836|Primary|Global Improvement Scale|Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.|Measured for seven days at the end of 2 weeks treatment and average score is calculated|||units on a scale||Standard Deviation|Mean
116315|NCT00680797|Primary|Insulin Sensitivity|As measured by change in insulin levels pre- and post-hormone changes|6 weeks|Two participants had missing values post-intervention therefore number of participants analyzed total 31.||micro International Units/mL||Standard Deviation|Mean
116316|NCT00680771|Primary|Positive Antibody Response|Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL.|3 Months after initial vaccination|From subjects with complete data only.||participants|||Number
116317|NCT00680745|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
116631|NCT00677690|Secondary|Dyspnoea|The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.|5 weeks|||units on a scale||Standard Deviation|Mean
116319|NCT00680745|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.|At Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
116320|NCT00680745|Secondary|Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise|To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
116321|NCT00680745|Secondary|Adjusted Mean Change in Body Weight|To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
116322|NCT00680745|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
116323|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|8-Hour|||mm||95% Confidence Interval|Mean
116324|NCT00680706|Primary|Effect of Thiamine Supplementation on Dyspnea|Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.|Baseline|||mm||95% Confidence Interval|Mean
116325|NCT00680628|Primary|Number With Recurrent Venous Thromboembolism and/or Severe Post-phlebitic Syndrome||90 days|||participants|||Number
116326|NCT00680628|Primary|Number With Functional Cardiopulmonary Limitations Assessed With a Composite Measurement (Six Minute Walk Distance, Right Ventricular Function and Quality of Life Score on the SF-36)||90 days|||participants|||Number
116327|NCT00680628|Primary|Number of Patients With Cardiogenic Shock or Respiratory Failure From Pulmonary Embolism and Number of Patietnts With Major Hemorrhage||1,2,3,4, and 5 days|||participants|||Number
116328|NCT00680524|Primary|Acceptability to Providers and Patients|Patients and providers rated the components of the intervention on a 5 point scale where 1 = poor and 5 = excellent and average ratings for each group is reported below|Six months|||units on a scale||Standard Deviation|Mean
116329|NCT00680459|Secondary|Recurrence of Central Venous Line Infection Within 35 Days of Enrollment||35 days|||# of pts with recurrent infection|||Number
116330|NCT00680459|Secondary|Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study||35 days|||number of lines preserved|||Number
116331|NCT00680459|Primary|Clearance of Central Venous Line Infection by Day 6 of Study||6 days|||number of CVL cleared|||Number
116332|NCT00680407|Post-Hoc|Efficacy - Improvement by at Least 2 Points in Histology (NAS) - With NAS Without Cirrhosis|This outcome measure excludes the substantial percentage (62.8%) of patients with baseline biopsies that were deemed ineligible (per inclusion criteria) by the central pathologist due to NAS <4 or absence of NASH (nonalcoholic steatohepatitis) (n=34), NASH with presence of cirrhosis (n=1), or slides unavailable/not evaluable for reading (n=14).|48-50 week treatment period|Subgroup of ITT (Intent to Treat) Patients with NASH and without cirrhosis population||participants|||Number
116333|NCT00680407|Secondary|Safety - Occurrence of a Dose-limiting Toxicity||48-50 week treatment period|||participants|||Number
116334|NCT00680407|Primary|Efficacy - Improvement by at Least 2 Points in Histology (NAS)||48-50 week treatment period|||participants|||Number
116335|NCT00680368|Secondary|Intraclass Correlation Coefficient for Test-retest Reliability for Attending Physicians|Assesses the test-retest reliability among repeated responses to surveys administered to attending physicians only.|24 hours|||Intraclass Correlation Coefficient||95% Confidence Interval|Number
116336|NCT00680368|Secondary|Intraclass Correlation Coefficient Assessing Test-retest Reliability for Resident Physicians|Assesses the test-retest reliability of repeated responses for resident physicians only to report the total time spent during resident supervision.|24 hours|||Intraclass Correlation Coefficient||95% Confidence Interval|Number
116337|NCT00680368|Primary|Intraclass Correlation Coefficient Between Physician Resident and Attending Physician.|Describes agreement between physician resident and attending physician assessment of total resident supervision time for a given patient and patient care clinical encounter.|24-hours|||Intraclass Correlation Coefficient||95% Confidence Interval|Number
116338|NCT00680316|Secondary|Change in Respiratory Symptom Domain Score From the Cystic Fibrosis Questionnaire Revised (CFQ-R) for Parents of Preschoolers and for Preschoolers|"The CFQ-R for Preschoolers and the CFQ-R for Parents of Preschoolers was designed specifically to measure the impact of CF for patients with a diagnosis of CF. Each question is answered using a 4-point Likert scale.~In order to calculate the domain/symptom scale scores, the following algorithm is followed~Re-number items which have been reverse coded~Calculate the mean of the items to be included. If more than half of the items are missing, then the score is considered missing~Re-scale to result in a scaled score which ranges from 0 to 100, with higher scores indicating better health"|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
116365|NCT00679939|Other Pre-specified|Percent Change in Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.||percent change|||Number
116339|NCT00680316|Secondary|Change in Resistance at 4, 6, 8, and 10 Hz (Rrs4, Rrs6, Rrs8, and Rrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Resistance is complex measure that incorporates the lack of changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (10Hz was used for the secondary endpoint).|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
116340|NCT00680316|Secondary|Change in Reactance at 4, 6, and 10 Hz (Xrs4, Xrs6, and Xrs10)|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
116341|NCT00680316|Primary|Change in Reactance at 8 Hz (Xrs8) From Visit 2 to Visit 3 (Change From Baseline at Visit 2 to Visit 3, After Study Drug Treatment).|The fundamental principle of forced oscillometry is that lung function can be assessed by measuring changes in pressure and flow in response to external pressure applied at the airway opening. Reactance is complex measure that incorporates the changes in pressure and volume and the rate of these changes in response to pressure oscillations at a specific frequency. (8Hz was used for the primary endpoint). Reactance is thought to reflect the elastic properties of the lung.|from Visit 2 to Visit 3 (16 +/- 2 days)|Children were unable to perform forced oscillometry (FOT) or did not remain stable during the study. No efficacy analyses were performed because no patients had complete (pre- or post-treatment) data for pulmonary function tests, including FOT.|||||
116342|NCT00680186|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout|TS||participants|||Number
116343|NCT00680186|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.|From first intake of study drug to last contact date|TS||participants|||Number
116344|NCT00680186|Secondary|Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events|"Major bleeding events (MBE) are defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) are defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
116345|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE|Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
116346|NCT00680186|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
116347|NCT00680186|Secondary|Number of Participants Who Died Due to VTE|VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.|From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)|FAS||participants|||Number
116348|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
116366|NCT00679939|Other Pre-specified|Percent Change in Percentage of Free Estradiol From Week 52 to Week 76|Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed.||percent change|||Number
116349|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic DVT|Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
116350|NCT00680186|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|FAS||participants|||Number
116351|NCT00680186|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
116352|NCT00680121|Secondary|Symptom Checklist-90 (SCL-90): Global Severity Index|The SCL-90 is a brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators. It provides an overview of symptom severity and intensity. The outcome measures psychiatric symptoms using a 30-item scale reported as t-scores relative to a normative population.|6 Months|||t-score||Standard Deviation|Mean
116353|NCT00680121|Secondary|Barrett Impulsivity Scale: Total Impulsiveness|Scale measures impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Items are scored on a 4 point scale with 1 point equaling rarely/never up to 4 points equaling almost always/always. Total impulsivity score ranges from 30 (least impulsive) to 120 (most impulsive). The higher the score the higher the level of impulsiveness.|6 Months|||scores on a scale||Standard Deviation|Mean
116354|NCT00680121|Secondary|Alcoholism Severity Scale|The alcoholism severity scale measures the severity of a person's dependence to alcohol. The scale ranges from a score of 0 (least severe) to 33 (most severe). The higher the score the worse the dependence.|6 Months|||scores on a scale||Standard Deviation|Mean
116355|NCT00680121|Primary|Change in Average Daily Alcohol Consumption|measured as standard drinks of alcohol per day (SD/day)|Change from Baseline to 6 Months|||alcoholic drinks per day||Standard Deviation|Mean
116356|NCT00680056|Secondary|Mean Score on the Transitional Dyspnea Index (TDI)|TDI is a multidimensional clinical instrument developed to provide a comprehensive assessment of change in dyspnea after an intervention, considering three components (functional impairment, magnitude of task, and magnitude of effort). It ranges from -9 (major deterioration) to +9 (major improvement).|After 2 week of each treatment|||score on scale||Standard Deviation|Mean
116357|NCT00680056|Primary|Percentage Change in Exercise Tolerance From Baseline at 2 Weeks|Percentage change from baseline in time to the limit of tolerance on a high intensity constant-speed treadmill exercise test (with a speed corresponding to 80% of that obtained during incremental test)|Baseline and after 2 weeks with each treatment|The specific period where the patient received a given treatment were analysed together.||Percentage change||Standard Error|Mean
116358|NCT00680043|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood transfusion during the previous 8 weeks.|Weeks 1 to 28|Full Analysis Population||percentage of participants|||Number
116359|NCT00680043|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods||Weeks 1 to 28|Full Analysis Population||percentage of participants|||Number
116360|NCT00680043|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.|Baseline and Weeks 21-28|Full Analysis Population||g/dL||Standard Deviation|Mean
116361|NCT00680017|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.|High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Least Squares Mean
116362|NCT00680017|Primary|Median Percent Change in Triglycerides From Baseline to Week 8.|Triglycerides were measured in milligrams/deciliter.|Baseline to 8 weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 postbaseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Inter-Quartile Range|Median
116363|NCT00679952|Secondary|Severity of Pancreatic Fistulas||2 years||||||
116364|NCT00679952|Primary|Number of Patients With Pancreatic Fistula|"pancreatic fistula rate is stratified according to ISGPF criteria.~Grade A; No major impact Grade B; Clinically relevant fistula, specific treatment may be required Grade C; Most severe form of fistula, with a high mortality rate"|postoperative 1 week|||participants|||Number
119085|NCT00656058|Secondary|Number of Participants With Chronic Graft Versus Host Disease (cGVHD) - Skin|cGVHD was defined by the National Institutes of Heath (NIH) Consensus staging.|Baseline, 3 month and 6 months on study, and 6 and 18 months post study drug.||12/2016||||
116367|NCT00679939|Secondary|Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
116368|NCT00679939|Secondary|Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76|SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116369|NCT00679939|Secondary|Percent Change in Free Testosterone From Week 52 to Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
116370|NCT00679939|Secondary|Percent Change From Baseline in Free Testosterone at Week 52 and Week 76|Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116371|NCT00679939|Secondary|Percent Change in Total Testosterone From Week 52 to Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
116372|NCT00679939|Secondary|Percent Change From Baseline in Total Testosterone at Week 52 and Week 76|Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116373|NCT00679939|Post-Hoc|Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from Week 52 was calculated as the Week 76 value minus the Week 52 value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||millimoles per Liter (mmol/L)||Standard Error|Mean
116374|NCT00679939|Secondary|Percent Change in Serum Estradiol From Week 52 to Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
116375|NCT00679939|Secondary|Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76|Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116376|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76|AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from baseline was calculated as the Week 52or Week 76 value minus the baseline value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||millimoles per Liter (mmol/L)||Standard Error|Mean
116377|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116378|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116379|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116380|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (orWeek 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116381|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
116382|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116383|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
116384|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116385|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116386|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116387|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from Baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116388|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116389|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
121419|NCT00631020|Primary|Acceptance of Nicotine Replacement Therapy|Participants were offered optional nicotine replacement therapy (NRT). The number of participants that opted for NRT was measured.|week 2|||participants|||Number
116390|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116391|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
116392|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116393|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116394|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116395|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116396|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days(or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116397|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
116398|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116399|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
116400|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 daysor Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days(or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN.|Baseline, Week 52 plus 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116401|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116402|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116403|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days|Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||millimeters||Standard Error|Mean
116404|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116405|NCT00679939|Post-Hoc|Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days|vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
116406|NCT00679939|Secondary|Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
116407|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76|Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116408|NCT00679939|Primary|Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52+10 days and Week 76+10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116409|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 76+10 days|Safety Population. Only evaluable participants with a value at baseline and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
123902|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
116410|NCT00679939|Secondary|Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
116411|NCT00679939|Secondary|Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76|Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116412|NCT00679939|Secondary|Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed.||percent change|||Number
116413|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76|CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116414|NCT00679939|Secondary|Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 and Week 76|Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. One participant did not have P1NP measured.||percent change|||Number
116415|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76|BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52, and Week 76|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed.||percent change|||Number
116416|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116417|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET and Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for all of the DXA measurements.||percent change||Standard Error|Mean
116418|NCT00679939|Secondary|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 10 days and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.||percent change||Standard Error|Mean
116419|NCT00679939|Post-Hoc|Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days|vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-posterior is the upper and back section of the FN.|Baseline and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||mg/cm^3||Standard Error|Mean
116726|NCT00676520|Secondary|Clinical Device Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of lesions|Participants|95% Confidence Interval|Number
116420|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116421|NCT00679939|Post-Hoc|Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116422|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116423|NCT00679939|Post-Hoc|Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116424|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116425|NCT00679939|Post-Hoc|Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116426|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116427|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116448|NCT00679627|Secondary|Change From Baseline in Caregiver Time Spent With the Patient Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|The table below presents the number of days that caregiving activities were provided during the past week.|Baseline, Months 12 and 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.||Days||Standard Deviation|Mean
116428|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days|vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116429|NCT00679939|Post-Hoc|Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Week 52 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/ vBMD at Week 52 + 30 days x 100% and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116430|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days|Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Baseline was calculated as (vBMD at Week 52+30 days (or Week 76+30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by ANCOVA with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116431|NCT00679939|Post-Hoc|Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Week 52 + 30 days and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116432|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (BMD at Week 52 + 30 days (orWeek 76 + 30 days) minus BMD at baseline)/BMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed.||percent change||Standard Error|Mean
116433|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (BMD at Week 52 + 30 days (or Week 76 + 30 days) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 30 days, and Week 76 + 30 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for all of the DXA measurements.||percent change||Standard Error|Mean
116434|NCT00679939|Post-Hoc|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 10 days or Week 76 + 10 days was calculated as (BMD at Week 52 + 10 days (or Week 76 + 10 days ) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline, Week 52 + 10 days, and Week 76 + 10 days|Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 10 days after initiating OL MET or at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for the DXA lumbar spine measurement.||percent change||Standard Error|Mean
116449|NCT00679627|Secondary|Change From Baseline in Patient Accommodation Measured Using the Assessment of Subject Accommodation Status and Caregiver Burden (APAS-CarB)|The APAS-CarB is a measure used to evaluate participant status and caregiver burden. The table below presents Patient Accommodation assessed as the percentage of participants “home with friend or relative” using the APAS-CarB.|Baseline, Months 12 and 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline APAS-CarB measure.||Percentage of participants|||Number
116435|NCT00679939|Secondary|Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52|BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement.||percent change||Standard Error|Mean
116436|NCT00679939|Primary|Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52|FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.|Baseline and Week 52|Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET are included in this primary analysis.||percent change||Standard Error|Mean
116437|NCT00679913|Secondary|Morbidity|Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy|within 2 years after surgery|||participants|||Number
116438|NCT00679913|Primary|Survival|comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery|2 year after surgery|||participants|||Number
116439|NCT00679783|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.|||Days||Full Range|Median
116440|NCT00679783|Secondary|CA-125 Levels (Ovarian Cancer Patients Only)|A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.|24 weeks|||Percentage of participants||95% Confidence Interval|Number
116441|NCT00679783|Secondary|Best Percentage Change From Baseline in Tumour Size|The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.|||Percentage||Full Range|Median
116442|NCT00679783|Secondary|Duration of Response|Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.|RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.|||Days||Full Range|Median
116443|NCT00679783|Secondary|Disease Control Rate (DCR)|Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)|16 Weeks|||Percentage of participants||95% Confidence Interval|Number
116444|NCT00679783|Primary|Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines|Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.|||Percentage of participants||95% Confidence Interval|Number
116445|NCT00679627|Secondary|Change From Baseline in the Disability Assessment in Dementia (DAD) Subscales (Initiation, Planning and Organization, Effective Performance, Basic, Instrumental, and Leisure)|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|This analysis was performed in the intent-to-treat population which included all randomized participants who had at least 1 postbaseline DAD measure.||Scores on scale||Standard Deviation|Mean
116446|NCT00679627|Secondary|Change From Baseline in the Mini–Mental State Examination (MMSE) Subscales (Orientation, Registration, Attention and Calculation, Recall, and Language)|The MMSE, is a validated, brief examination that rates subjects on orientation (total score, 10), registration (total score, 3), attention (total score, 5), calculation (total score, 5), recall (total score, 3), and language (total score, 9). The maximum score is 30 (only the higher of the two scores for attention and calculation [each with a maximum score of 5] was used). A higher score compared with baseline indicates less impairment.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.||Scores on scale||Standard Deviation|Mean
116447|NCT00679627|Secondary|Change From Baseline in Institutional Status|This table describes the number of participants who were reported as institutionalized at baseline and Month 24.|Baseline, Month 24|The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline measure.||Number of Participants|||Number
116450|NCT00679627|Secondary|Change From Baseline in Disability Assessment in Dementia (DAD) Scores|The DAD assesses physical activities of daily living and instrumental-activities of daily livings of participants with Alzheimer disease. This measure is a validated, disability assessment scale that collects information regarding the ability of a participant to initiate, plan, organize, and perform activities of daily living, as based on a structured interview with the caregiver. The maximum scores were 13 for initiation, 10 for planning and organizing, and 17 for effective performance in order to yield a total maximum score of 40. These scores were normalized to a scale of 100 for analysis.A higher score, or percentage of items that can be performed represents fewer disabilities in carrying out activities of daily living while a lower percentage indicates an increase in disabilities.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline DAD measure.||Scores on scale||Standard Deviation|Mean
116451|NCT00679627|Secondary|Change From Baseline in the Mini–Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients’ cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 6|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.||Scores on scale||Standard Deviation|Mean
116452|NCT00679627|Primary|The Number of Deaths Reported in Participants|An external Data Safety Monitoring Board (DSMB) was assigned for this study to monitor the progress of the study and to ensure that the safety of participants was not compromised.|Up to 2 years|The safety analysis was performed on the safety population, ie, all randomized participants who received at least one dose of the study drug.||Number of Participants|||Number
116453|NCT00679627|Primary|Change From Baseline in the Mini–Mental State Examination (MMSE) Score|The MMSE is a brief 30-point questionnaire test that is used or the assessment of dementia patients’ cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.|Baseline, Month 24|An intent-to-treat (ITT) with last observation carried forward (LOCF) approach was used for the primary analysis. The ITT analysis set included all randomized participants who received at least 1 dose of treatment and had at least 1 postbaseline MMSE measure.||Scores on scale||Standard Deviation|Mean
116454|NCT00679432|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.~As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).||percentage of patients||95% Confidence Interval|Number
116455|NCT00679432|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).||percentage of patients||95% Confidence Interval|Number
116456|NCT00679432|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).||percentage of patients||95% Confidence Interval|Number
116457|NCT00679380|Secondary|Endoscopic Improvement.|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.~As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted."|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.||percentage of patients||95% Confidence Interval|Number
116458|NCT00679380|Secondary|Clinical Improvement.|Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.||percentage of patients||95% Confidence Interval|Number
116459|NCT00679380|Primary|Clinical and Endoscopic Remission.|Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.|8 weeks|Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.||percentage of patients||95% Confidence Interval|Number
116460|NCT00679354|Other Pre-specified|Pharmacogenetic Polymorphisms in Drug Transporters and Relate to Cilengitide Disposition|Cilengitide systemic exposure as measured by AUC and systemic clearance as the pharmacologic variable in this genotype-phenotype analysis will be used.|At baseline||||||
116461|NCT00679354|Secondary|Pharmacokinetics of Cilengitide in Plasma, Including of the Central Compartment (Vc), Elimination Rate Constant (Ke), and Half-life (t1/2), and Systemic Clearance (Cl)|Cilengitide plasma concentration-time data will be fit to a compartmental pharmacokinetic model using MAP-Bayesian estimation as implemented in ADAPT II. Cl will be calculated using standard equations and area under the curve (AUC)0-o∞ will be calculated using the log-linear trapezoidal method.|At baseline and 1, 3, and 6 hours after the first dose of cilengitide||||||
116462|NCT00679354|Secondary|Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Rates of individual toxicities including that of symptomatic ITH will be summarized in each course of treatment using standard descriptive statistical methods.|Up to 5 years||||||
116463|NCT00679354|Secondary|Time to Death (TTD)|The distribution of TTD will be analyzed separately using PL estimate.|Time from study enrollment to death from any cause, assessed up to 5 years||||||
116464|NCT00679354|Secondary|Time to Treatment Failure (TTF)|The distributions of TTF will be analyzed separately using PL estimate.|Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 5 years||||||
116465|NCT00679354|Secondary|Time to Tumor Progression (TTP)|The distributions of TTP will be analyzed separately using product limit (PL) estimate.|Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years||||||
116466|NCT00679354|Primary|Objective Response to Cilengitide|Objective response is defined as a complete response or partial response at 4 weeks that is sustained for at least another 4 weeks, or a stable disease at 4 weeks that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids, except when corticosteroids are being used to control hydrocephaly unrelated to tumor progression.|Up to 16 weeks|Six patients are considered inevaluable for objective response (including one ineligible patient) and excluded from analysis.||participants|||Number
116467|NCT00679341|Secondary|Plasma Concentration of Free Emtansine|Plasma samples were collected from all 67 patients in the trastuzumab emtansine group 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. The plasma samples were assayed for free emtansine in a mass-spectrometric assay.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.||ng/mL||Standard Deviation|Mean
116468|NCT00679341|Secondary|Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab|Serum samples were collected from all 67 patients enrolled in the trastuzumab emtansine arm using sparse pharmacokinetic sampling. Blood samples were collected prior to dosing and 30 minutes post-infusion of trastuzumab emtansine at Cycles 1 and 5. Serum samples were assayed for trastuzumab emtansine and total trastuzumab (sum of unconjugated trastuzumab and emtansine conjugated to trastuzumab) in indirect sandwich ELISAs. The area under the concentration-time curve (AUC) was estimated based on non-compartmental analysis using WinNonlin (Version 5.2.1) software.|Baseline through Cycle 5 (up to 4 months)|Pharmacokinetic evaluable population: Patients who had adequate concentration-time data to estimate at least 1 pharmacokinetic parameter.||day•μg/mL||Standard Deviation|Mean
116469|NCT00679341|Secondary|Time to Symptom Progression|Time to symptom progression was defined as the time from randomization to the first documentation of a ≥ 5-point decrease from baseline in the Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) subscale score of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B questionnaire is a valid and reliable measure of symptoms associated with breast cancer. The TOI-PFB is a 24-item subscale generated using 3 subsections (Physical Well-Being [7 items], Functional Well-Being [7 items], and Additional Concerns [10 items]) from the FACT-B questionnaire. Patients responded to each item on a scale of 0-4 (Not at all-Very much). The total score ranged from 0 to 96. A higher score indicates fewer symptoms. A positive change score indicates improvement.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with a Baseline and at least 1 post-Baseline valid score.||Months||95% Confidence Interval|Median
116470|NCT00679341|Secondary|Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|CB was defined as an objective response (complete response [CR], partial response [PR]) or stable disease (SD) for 6 months after randomization. For target lesions (TL), CR=the disappearance of all TL; PR=at least a 30% decrease in the sum of the longest diameter (LD) of TL, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of TL, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions. For non-TL, CR=the disappearance of all non-TL; PR=the persistence of 1 or more non-TL; SD=the persistence of 1 or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits; PD=the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TL.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measurable disease at Baseline.||Percentage of patients||90% Confidence Interval|Number
116471|NCT00679341|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to investigator-assessed radiographic or clinical disease progression or death on study from any cause. For target lesions, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, disease progression was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline. Only patients with an objective response were included in the analysis.||Months||95% Confidence Interval|Median
121724|NCT00627497|Secondary|Leg Pain Success Rate|Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation|||percentage of participant|||Number
116472|NCT00679341|Secondary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|All randomized patients with measureable disease at Baseline.||Percentage of patients||90% Confidence Interval|Number
116473|NCT00679341|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death from any cause. Patients who were alive at the time of analysis were censored at the date on which they were last known to be alive. Patients with no post-baseline were censored at the date of randomization plus 1 day.|Baseline through the data cut-off date of 31 Aug 2011 (up to 2 years, 11 months)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
116474|NCT00679341|Primary|Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)|PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day.|Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
116475|NCT00679302|Secondary|New Lesion Development and Spread of Skin Abscesses|The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.|10-14 days and 3 month|||participants|||Number
116476|NCT00679302|Primary|Skin Abscess Resolution||10-14 days|||participants||95% Confidence Interval|Number
116477|NCT00679263|Secondary|FEV1 Percent Predicted Changes From Base Line|The primary efficacy variable will be the change from baseline in FEV1, expressed as percent of predicted at hour 1 after the start of the infusion. Analysis of all other variables at all other time points will be considered secondary.|Day 1 to Day 2|||FEV1 percent predicted||Standard Deviation|Mean
116478|NCT00679263|Primary|Number of Patients Reported to Have Adverse Events||Day 1 to Day 2|||participants|||Number
116479|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Investigator Assessment|Clinical benefit was defined as participants with an objective response (confirmed complete or partial response) or stable disease at 6 months. Patients with stable disease at 6 months were defined as patients who achieved at least stable disease based on tumor assessments and remained alive and progression free at 6 months. Response was based on the Investigator's assessment.|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Patients without a post-baseline tumor assessment were considered to have experienced no clinical benefit.||percentage of participants||95% Confidence Interval|Number
116480|NCT00679211|Secondary|Duration of Objective Response Based on Investigator Assessment|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was determined by the Investigator's assessment.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.||months||95% Confidence Interval|Median
116481|NCT00679211|Secondary|Progression-free Survival Based on Investigator Assessment|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population||months||95% Confidence Interval|Median
116493|NCT00679055|Secondary|Change From Baseline in Messenger Ribonucleic Acid (mRNA)|mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.|||||
116519|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)|AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure.|Day 14|PK Subpopulation: all participants who were treated with eltrombopag and provided evaluable PK samples||hour*micrograms (ug)/milliliter (mL)||95% Confidence Interval|Geometric Mean
116482|NCT00679211|Secondary|Objective Response Based on Investigator Assessment|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Response was assessed by the study Investigator.~CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.~PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to be non-responders.||percentage of participants||95% Confidence Interval|Number
116483|NCT00679211|Secondary|Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review|"Clinical benefit was defined as participants who achieved an objective response (confirmed complete or partial response) between randomization and 1 January 2010, or with stable disease at 6 months. Stable disease at 6 months was defined as participants who achieved at least stable disease based on tumor assessments by the independent review facility, and remained alive and progression-free at 6 months.~Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, and no new lesions and/or unequivocal progression of existing nontarget lesions. Response was assessed by the independent review facility."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population. Participants without a post-baseline tumor assessment were considered to have experienced no clinical benefit.||percentage of participants||95% Confidence Interval|Number
116484|NCT00679211|Secondary|Progression-free Survival as Assessed Through Independent Radiologic Review|"Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Disease progression was assessed by the independent review facility.~For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Treated population.||months||95% Confidence Interval|Median
116485|NCT00679211|Secondary|Duration of Objective Response as Assessed Through Independent Radiologic Review|"For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant’s objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was assessed by the independent review facility.~Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.~For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response."|From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.|Participants with an objective response.||months||95% Confidence Interval|Median
116486|NCT00679211|Primary|Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST).~CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions.~PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions.~The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled)."|From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).|Treated population (patients who received at least one dose of T-DM1). Participants without a post-baseline tumor assessment were considered to be non-responders.||percentage of participants||95% Confidence Interval|Number
116487|NCT00679081|Secondary|Subject Preference Measures||6-months||||||
116488|NCT00679081|Secondary|Post-Surgical Subject Comfort Measures||4-weeks||||||
116489|NCT00679081|Secondary|Aesthetic Measures||6-months||||||
116490|NCT00679081|Secondary|Periodontal Health Measures||6-months||||||
116491|NCT00679081|Primary|Overall Rate of Adverse Events (AEs)|"Adverse events were collected at every visit throughout the 6 month duration.~An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition."|6-month|||participants|||Number
116492|NCT00679055|Secondary|Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized.|up to 14 weeks|All enrolled participants who received at least one dose of study drug.||Particpants|||Number
121740|NCT00627406|Secondary|Pregnancy Rate||from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test|||participants|||Number
116494|NCT00679055|Primary|Change From Baseline in Cluster of Differentiation 68 (CD68)|CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque.|Baseline and Week 12|Study terminated early. Planned analyses was not performed.|||||
116495|NCT00678899|Secondary|AzBio Sentence Score-Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:~The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported."|6 Months Postactivation|||percentage of subjects|||Number
116496|NCT00678899|Secondary|Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear|"Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:~The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported."|6 Months Postactivation|||percentage of subjects|||Number
116497|NCT00678899|Primary|AzBio Sentence Score in Noise - Treated Ear (Co-Primary)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.~The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score."|6 Months Postactivation|||percentage of words correct||Standard Deviation|Mean
116498|NCT00678899|Primary|Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)|"The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.~The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study."|6 Months Postactivation|||percentage of words correct||Standard Deviation|Mean
116499|NCT00678834|Primary|"The Levels of TCT in the Tissues of Non-healthy Subjects and in the Tissue of Healthy Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)"||After at least 1 month of supplementation|Box plots were used to determine outliers defined as values . the 75th percentile plus 1.5 times the IQR or values , the 25th percentile minus 1.5 times the IQR (20). Outliers were identified and it was determined that laboratory procedural errors were the cause and thus removed from the analysis.||nmol/g||Standard Deviation|Mean
116500|NCT00678795|Secondary|Change From Baseline in the Mean Number of Daily Voids at the End of Treatment|Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
116501|NCT00678795|Secondary|Patient’s Global Impression of Change|Subjects were asked at completion or withdrawal to give their impression of the overall change in their condition since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The numbers who scored 1, 2, or 3 are presented.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||participants|||Number
116502|NCT00678795|Secondary|Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment|Subjects subjectively assessed the severity of their urinary incontinence and general bladder symptoms by responding to the following question on a Numerical Rating Scale: My bladder condition, taking everything into account, causes me: 0 = “no problems” and 10 = “intolerable problems”. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
116503|NCT00678795|Secondary|Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal)|The I-QOL consists of 22 items from three subscales; avoidance/limiting behaviour (eight items), psychosocial impact (nine items) and social embarrassment (five items). The responses to each of the 22 items were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation. The transformation formula used for the I-QOL total scores is: Transformed score = 100 x (the sum of the items - lowest possible score) / Possible raw score range. An increase in score indicates an improvement in QOL.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||units on a scale||Standard Deviation|Mean
117347|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
116504|NCT00678795|Secondary|Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment|Subjects documented in the daily subject diary, the total number of incontinence pads they had used each day. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||pads used daily||Standard Deviation|Mean
116505|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment|Subjects documented in the daily subject diary each instance of nocturia, and the time that each took place (as for the recording of incontinence episode frequency). Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
116506|NCT00678795|Secondary|Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment|Subjects documented in the daily subject diary each instance of urgency, and the time that each took place, as for the recording of incontinence episode frequency. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|Daily diary entries throughout 10 week study period|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
116507|NCT00678795|Primary|Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment|To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.|0 - 10 weeks|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.||number of daily episodes||Standard Deviation|Mean
116508|NCT00678691|Primary|Brief Fatigue Inventory|This scale measures overall fatigue due to medical illness. range is 0-80 with 80 being severe fatigue|8 weeks|last observation carried forward after power analysis calculated||units on a scale||Standard Deviation|Mean
116509|NCT00678639|Secondary|Adverse Events During Magnetic Resonance Imaging (MRI) Scanning|Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.|Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.|Only participants undergoing Cardiac MRI scanning are eligible for this endpoint. Only 49 of the 53 participants randomized to observation unit arm underwent CMR testing. Nine participants in the usual care arm underwent CMR testing.||Participants|||Number
116510|NCT00678639|Secondary|Number of Participants Who Utilized the Indicated Health Care Procedures|Measured as self report, assessed during telephone follow-up.|30d, 3mo, 6mo, and 1 year|Data reported through 30 days. Follow-up with participants is ongoing. Results will be updated once follow-up is complete.||Participants|||Number
116511|NCT00678639|Secondary|The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging|The number of participants able to complete the planned imaging sequences will be measured.|Emergency Department (ED) arrival through hospital discharge|All participants randomized to the Observation Unit - Cardiac Magnetic Resonance Imaging (OU-CMR) arm were analyzed based on intention to treat.||Participants|||Number
116512|NCT00678639|Secondary|Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days|Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision. Remaining participants will be considered to have incorrect admission decisions.|30 Days|4 participants (3 in the usual care group and 1 in the ED obs unit group) left Against Medical Advice (AMA) prior to completion of their evaluation and were excluded from this analysis. Analysis was per intention to treat.||Participants|||Number
116513|NCT00678639|Primary|Cost of Index Hospitalization|Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial. The primary outcome is examining the cost for this visit.|Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours|All participants were analyzed based on intention to treat.||US Dollars||Inter-Quartile Range|Median
116514|NCT00678587|Secondary|Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures|The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.||unscheduled events||Standard Deviation|Mean
116515|NCT00678587|Secondary|Mean Number of Days Spent in the Hospital|The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population. Data are missing for some participants.||days||Standard Deviation|Mean
116516|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, CL/F|CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time.|Day 14|PK Subpopulation||Liters/hour||95% Confidence Interval|Geometric Mean
116517|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, t1/2|t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration.|Day 14|PK Subpopulation||hours||95% Confidence Interval|Geometric Mean
116518|NCT00678587|Secondary|Pharmacokinetics (PK) of Eltrombopag, Cmax|Cmax is the steady state peak plasma concentration of a drug observed after its administration.|Day 14|PK Subpopulation||ug/mL||95% Confidence Interval|Geometric Mean
116520|NCT00678587|Secondary|Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results|A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site.|Screening, Baseline, Day 15, and Withdrawal|Safety Population. Data were missing for some participants.||participants|||Number
116521|NCT00678587|Secondary|Number of Participants With Renal Function Abnormality|Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test.|Screening to Procedure +30 day follow-up or early withdrawal|Safety Population||participants|||Number
116522|NCT00678587|Secondary|Number of Participants With the Indicated Event Relating to Vision|The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart).|Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)|Safety Population: all randomized participants who received at least one dose of study medication. Data are missing for some participants.||participants|||Number
116523|NCT00678587|Secondary|Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant||Screening to Procedure +30 day follow-up or early withdrawal|Safety Population||participants|||Number
116524|NCT00678587|Secondary|Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations.|Screening to Procedure +30 day follow-up or early withdrawal|Safety population: all randomized participants who received at least one dose of study medication||participants|||Number
116525|NCT00678587|Secondary|Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.||participants|||Number
116526|NCT00678587|Secondary|Median Platelet Count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 Day Follow-up; Early Withdrawal; and Maximum Post-baseline|Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).|Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline|ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.||Gi/L||Full Range|Median
116527|NCT00678587|Secondary|Number of Participants With the Indicated Number of Platelet Transfusions Administered|Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study.|Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population||participants|||Number
116528|NCT00678587|Secondary|Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures|The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).|Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|ITT Population||participants|||Number
116529|NCT00678587|Primary|Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures|A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.|Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26|Intent-to-Treat (ITT) Population: all participants who were randomized to treatment||participants|||Number
116530|NCT00678535|Secondary|Safety - Number of Participants With Adverse Events (AEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Time from first dose up to Day 30 after last dose of study treatment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|The safety population included all participants who received at least one dose of any trial treatment that is, cetuximab, cisplatin, or capecitabine.||participants|||Number
116531|NCT00678535|Secondary|Quality of Life (QoL) Assessed by EuroQol 5Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 single items are combined to obtain a single index score that is health utility index (HUI) score reflecting subject's preferences for different health states. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EuroQoL EQ-5D questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
116532|NCT00678535|Secondary|Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|Mean global health status and social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Analysis population included participants who had at least one evaluable EORTC QLQ-C30 questionnaire and were also included in the ITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
116533|NCT00678535|Secondary|Best Overall Response (BOR) Rate: Independent Review Committee (IRC) Assessments|The BOR rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) from the IRC.|Every 6 weeks until progression, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.||percentage of participants||95% Confidence Interval|Number
116534|NCT00678535|Secondary|Overall Survival (OS)|The OS time is defined as the time from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date, (31 Mar 2012)|ITT population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
116535|NCT00678535|Primary|Progression-free Survival (PFS) Time: Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 30 Jun 2008 until cut-off date (31 Mar 2012)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.||months||95% Confidence Interval|Median
116536|NCT00678470|Primary|Number of Patients Who Were Both Intralesional and Intramuscular Responders.|"Patients were first injected with alefacept into a single target plaque. Those who had improvement in the plaque from baseline were deemed intralesional responders. All the patients then were injected with alefacept intramuscularly. The patients who had a 70% or greater improvement in their psoriasis severity score (includes assessment of entire body) were systemic responders to alefacept. The number of patients who were both intralesional and systemic responders was measured."|12 weeks after intramuscular injection of alefacept.|14 of 18 patients completed the study.||Participants|||Number
116537|NCT00678470|Primary|To Evaluate the Effectiveness of Intralesional Alefacept Administration as Defined by the Psoriasis Severity Assessment Score Followed by the Evaluation of the Effectiveness of Intramuscular Alefacept Administration.||6 months||||||
116538|NCT00678418|Secondary|Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24|Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). Change from baseline was calculated per subject as the percent of subjects' self-reported opioid-free days in Part A minus the percent of opioid-free days prior to the subjects' hospitalization for pre-study detoxification.||Percentage of opioid-free days||Inter-Quartile Range|Median
116539|NCT00678418|Secondary|Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)|Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.|24 Weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).||Percentage of participants who relapsed|||Number
116540|NCT00678418|Secondary|Craving Score: Change From Baseline|"Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 (No craving) to 100 (highest possible craving)."|Baseline to 6 months (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).||Units on a scale||95% Confidence Interval|Least Squares Mean
116541|NCT00678418|Secondary|Days to Discontinuation During Part A|Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.|168 days (24 weeks)|Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).||Days to study discontinuation||95% Confidence Interval|Median
116542|NCT00678418|Primary|Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)|Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.|20 weeks|Analyses include all randomized subjects who received at least 1 dose of study drug (Intent-to-treat [ITT] population).||Percentage of opioid-free weeks||Inter-Quartile Range|Median
116543|NCT00678392|Secondary|EQ-5D Visual Analog Scale (EQ-5D VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)||2099||||
116544|NCT00678392|Secondary|Euro Quality of Life Questionnaires- 5 Dimension (EQ-5D) Index Score|EQ-5D was a standardized, PRO measure of health. It provided a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health).|Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)||2099||||
116545|NCT00678392|Secondary|FKSI-Disease Related Symptoms (FKSI-DRS) Score|FKSI-DRS is a subset of FKSI which is a questionnaire for FACT–Kidney Symptom Index used to assess PROs for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0 to 36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.|Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)||2099||||
116546|NCT00678392|Secondary|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score|FKSI was a questionnaire for Functional Assessment of Cancer Therapy (FACT) –Kidney Symptom Index used to assess patient-reported outcomes (PROs) for participants diagnosed with renal cell cancer. The FKSI contained 15 questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).|Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days)||2099||||
116547|NCT00678392|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|Week 6, Week 12, every 8 weeks thereafter up to 3 years||2099||||
116548|NCT00678392|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Week 6, Week 12, every 8 weeks thereafter up to 3 years||2099||||
116549|NCT00678392|Secondary|Overall Survival (OS)|Overall survival was defined as the duration from assignment to study treatment to death. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Week 6, Week 12, every 8 weeks thereafter up to 3 years||2099||||
116550|NCT00678392|Primary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Week 6, Week 12, every 8 weeks thereafter up to 3 years|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
116551|NCT00678288|Secondary|Overall Survival|Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
116552|NCT00678288|Secondary|Duration of Response|Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
116553|NCT00678288|Secondary|Time to Progression|Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
116554|NCT00678288|Secondary|Response Rate|Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From start of treatment of the first subject until 14 months later, assessed every 8 Weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
116575|NCT00678041|Secondary|Adherence to CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
116555|NCT00678288|Primary|Progression-Free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|From start of treatment of the first subject until 14 months later, assessed every 8 weeks|Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats.|||||
116556|NCT00678249|Secondary|Percent of Participants With Binary Restenosis|Binary restenosis defined as lesions with greater than or equal to 50% diameter stenosis of the treatment area (calculated by a core lab).|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window (or the core lab could not assess the angiogram), then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
116557|NCT00678249|Secondary|Percent of Participants With Access Circuit Cumulative Patency (ACCP or Secondary Patency)|ACCP defined as patency (open to blood flow) following the index study procedure until the access is surgically revised or abandoned because of the inability to treat the original lesion. Multiple treatments for occlusions to restore patency are compatible with ACCP.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
116558|NCT00678249|Secondary|Percent of Participants With Access Circuit Assisted Primary Patency (ACAPP)|ACAPP defined as patency (open to blood flow)following the index study procedure until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
116559|NCT00678249|Secondary|Percent of Participants With Access Circuit Primary Patency (ACPP)|ACCP defined as patency (open to blood flow) following the index study procedure until access thrombosis or an intervention of a lesion anywhere within the access circuit.|6 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
116560|NCT00678249|Secondary|Percent of Participants With TAPP|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|2 month Follow-Up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
116561|NCT00678249|Secondary|Percent of Participants With Procedural Success|Procedural Success was defined as anatomic success (<30% residual stenosis) and at least one indicator of hemodynamic or clinical success|Index Procedure|||Percentage of Participants|||Number
116562|NCT00678249|Secondary|Percent of Participants With Successful Delivery of the Device|The ability to successfully deliver the FLAIR™ Endovascular Stent Graft. Successful delivery is the ability to deliver and seat the implant in the intended location of a stenosed segment of the venous anastomosis region of a synthetic access graft. This attribute is only applicable to the FLAIR and FLAIR Roll-in arms.|Index Procedure|The PTA Only group was not analyzed for this outcome measure because it is for successful delivery of the FLAIR study device (PTA Only is the control arm).||Percentage of Participants|||Number
116563|NCT00678249|Secondary|Total Number of Adverse Events|The safety endpoint was evaluated based on the incidence of adverse events observed within the same time interval. An adverse event was defined as any undesirable clinical occurrence in a patient that (a) is considered possibly or definietly device related by the investigator, (b) involves the access circuit (AV graft arterial anastomosis to the superior vena cava-right atrial junction) or the arm where the access circuit is located or (c) the investigator considers relevant to the objectives of this study. An adverse event could be mild, moderate or severe.|6 month Follow-Up|||total events|||Number
116564|NCT00678249|Primary|Percent of Participants With Treatment Area Primary Patency (TAPP)|TAPP was defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5 mm proximal or 5 mm distal to the study device or index balloon angioplasty treatment area), or thrombotic occlusion that involved the treatment area.|6 month follow-up|If a participant was lost to follow-up prior to the follow-up interval window, then the participant's status was considered missing for that time point and was not included in the ITT analysis.||Percentage of Participants|||Number
116565|NCT00678210|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.||units on a scale||Standard Error|Mean
116576|NCT00678041|Secondary|Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.|0 participants analyzed due to study termination.Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
117405|NCT00669396|Secondary|IUD Expulsion, Removal, or Perforation|patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.|6 months|||participants|||Number
116566|NCT00678210|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores and Total Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Baseline, Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. No imputation was done. n=participants evaluable for this measure at specified time points for each arm group respectively.||units on a scale||Standard Error|Mean
116567|NCT00678210|Secondary|Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF.||percentage of participants|||Number
116568|NCT00678210|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.||percentage of participants|||Number
116569|NCT00678210|Secondary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 2, 4, 8, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.||percentage of participants|||Number
116570|NCT00678210|Secondary|Percentage of Participants Achieving Physician’s Global Assessment (PGA) Score of “Clear” or “Almost Clear”|Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 2, 4, 8, 12, 14, 16|FAS included all participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values imputed using LOCF for week 2, 4, 8, 12 and no imputation done for week 14, 16. n=participants evaluable for this measure at specified time points for each arm group respectively.||percentage of participants|||Number
116571|NCT00678210|Primary|Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of investigational drug and had at least 1 valid post-baseline efficacy assessment. Missing values were imputed using last observation carried forward (LOCF).||percentage of participants|||Number
116572|NCT00678041|Secondary|Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
116573|NCT00678041|Secondary|Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
116574|NCT00678041|Secondary|Patient Perceptions Regarding CISC|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery||||||
116577|NCT00678041|Secondary|Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|6 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
116578|NCT00678041|Primary|Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation|Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.|6 to 8 weeks after surgery|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.|||||
116579|NCT00678015|Post-Hoc|Disease Progression at End of Study|End-of-study imaging was assessed for disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Progressive Disease (PD)=At least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, End of treatment (2-19 cycles)|At the time of calculation, 1 patient was still on study after 29 cycles||participants|||Number
116580|NCT00678015|Post-Hoc|Change in Prostate Specific Antigen Doubling Time (PSADT)|PSADT was calculated using the formula natural log 2 divided by the slope of the natural log of the PSA versus time. Pretreatment PSADT was calculated using a minimum of 3 values; end of study PSADT incorporated all measured PSA values on study starting Cycle 2-Day 1 until the patient was removed from the study.|Cycle 2 through end of treatment (up to 29 months)|At the time of PSADT calculations, one participant was still on study at 29 months, and 11 participants' time on study had ranged from 2-19 months||percentage change||Full Range|Median
116581|NCT00678015|Post-Hoc|PSA Decline|Number of participants experiencing PSA decline during the first 3 treatment cycles|Baseline; Monthly, up to 29 months after beginning treatment|||participants|||Number
116582|NCT00678015|Primary|Prostate Specific Antigen (PSA) Response According to Consensus Criteria|Participants who experienced a PSA decline of at least 50%, confirmed by a second PSA value 4 or more weeks later. The reference PSA for decline was a PSA measured within 2 weeks of beginning study treatment. If at most 1 PSA response was observed among the first 12 patients, then accrual would stop and the trial would close for futility.|Monthly, up to 29 months|||participants|||Number
116583|NCT00677924|Secondary|Best Overall Response|Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16|Overall Study|||Participants|||Number
116584|NCT00677924|Primary|Adverse Events|Number of patients experiencing an adverse event|Overall Study|Number of patients experiencing an adverse event||participants|||Number
116585|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides|Guidelines recommend that triglycerides be evaluated every 2 years|1 year|||percentage of days in the study period||Standard Deviation|Mean
116586|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol|Guidelines recommend that HDL cholesterol be evaluated every 2 years|1 year|||percentage of days in study period||Standard Deviation|Mean
116587|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol|Guidelines recommend that LDL cholesterol be evaluated every 2 years|1 year|||percentage of days in study period||Standard Deviation|Mean
116588|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Glucose/HbA1c|Guidelines recommend that blood glucose/HbA1c be evaluated every year|1 year|||percentage of days in the study period||Standard Deviation|Mean
116589|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure|Guidelines recommend that blood pressure be evaluated every 3 months|1 year|||percentage of days in the study period||Standard Deviation|Mean
116590|NCT00677898|Primary|Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Body Mass Index|Guidelines recommend that body mass index be evaluated every 3 months|1 year|||percentage of days in the study period||Standard Deviation|Mean
116591|NCT00677833|Secondary|Percentage of Participants With PfCRT in True Failures|A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.|Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.|||||
116592|NCT00677833|Secondary|Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status||Baseline to Day 42|Data for this outcome measure was not analyzed as per change in planned analysis.|||||
116593|NCT00677833|Secondary|Time to Recurrence of Parasitemia|Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).|Baseline (Day 0) to Day 42|mITT population, including participants in the Ivory Coast center.||Days||Full Range|Median
116594|NCT00677833|Secondary|Change From Nadir Hemoglobin Level at Days 14, 28, and 42|Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.|Day 14, 28, 42|"mITT population. N = number of participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."||g/dL||Standard Error|Mean
116595|NCT00677833|Secondary|Nadir Hemoglobin Level|Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.|Day 0 through Day 3|mITT population, including participants in the Ivory Coast center.||grams per deciliter (g/dL)||Standard Deviation|Mean
116596|NCT00677833|Secondary|Asexual Plasmodium Falciparum Parasite Clearance Time|Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.||Hours||Full Range|Median
116597|NCT00677833|Secondary|Fever Clearance Time|Calculated as time of first occurrence of two consecutive time points with temperature less than (<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or <37.5 degrees C/99.5 degrees F (oral).|Baseline to Day 42|mITT population, including participants in the Ivory Coast center.||Hours||Full Range|Median
116598|NCT00677833|Secondary|Percentage of Participants With Gametocytologic Response|Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|"mITT population. N= participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."||Percentage of participants|||Number
116599|NCT00677833|Secondary|Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)|Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 7, 14, 21, 28, 35, 42|"mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. n=participants who were evaluable at specified time points for each arm, respectively."||Percentage of participants|||Number
116600|NCT00677833|Secondary|Percentage of Participants With LPF in PP Population (PCR-corrected)|LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants|||Number
116601|NCT00677833|Secondary|Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)|LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants|||Number
116602|NCT00677833|Secondary|Percentage of Participants With LCF in PP Population (PCR-corrected)|"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|PP population, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants|||Number
116603|NCT00677833|Secondary|Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)|"LCF included participants who met any of the following criteria:~Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)~Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Days 7, 14, 21, 28, 35, 42|mITT population, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants|||Number
116604|NCT00677833|Secondary|Percentage of Participants With ETF in PP Population (PCR-corrected)|"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia~Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P.falciparum) on Day 3 with fever or~Last available P.falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|PP population, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants|||Number
116605|NCT00677833|Secondary|Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)|"ETF defined as participants who met the following criteria:~Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia~Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.~Parasitemia (P. falciparum) on Day 3 with fever or~Last available P. falciparum parasite count on Day 3 >=25% of the first available parasite count on Day 0 (Baseline).~PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation."|Day 0 up to Day 3|mITT population, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants|||Number
117406|NCT00669396|Secondary|Infection|diagnosis and treatment for pelvic inflammatory disease|6 months|||participants|||Number
116606|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in PP Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants||95% Confidence Interval|Number
116607|NCT00677833|Secondary|Percentage of Participants With PCR-uncorrected ACPR in the mITT Population|ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.|Days 7, 14, 21, 28, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population.||Percentage of participants||95% Confidence Interval|Number
116608|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in PP Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.||Percentage of participants||95% Confidence Interval|Number
116609|NCT00677833|Secondary|Percentage of Participants With PCR-corrected ACPR in the mITT Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Days 7, 14, 21, 35, 42|mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population.||Percentage of participants||95% Confidence Interval|Number
116610|NCT00677833|Primary|Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population|ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF – see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population.||Percentage of participants||95% Confidence Interval|Number
116611|NCT00677833|Primary|Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population|ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures [LCF] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)– see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.|Day 28|mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter [mcL];fever/history of fever >=38 degree Celsius[C] [rectal],37.2 degree C [axillary] or >=37.5 degree C [oral] within last 24 hours).Participants in Ivory Coast center excluded from analysis.||Percentage of participants||95% Confidence Interval|Number
116612|NCT00677820|Secondary|Number of Subjects Reporting SAEs and SNMCs|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.~An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-180|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
116613|NCT00677820|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)|"SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.~An SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant."|Days 0-28|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.||participants|||Number
116619|NCT00677807|Secondary|Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52|"The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates.~SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant."|Weeks 36, 44 and 52|"Extension Intent-to-treat population consisting of all participants who received at least one dose of study drug. n in each of the categories is the number of participants with data at the given time point. Missing data were imputed using LOCF but not by more than 14 weeks and not by carrying forward scores within 4 weeks of treatment start."||Score on a Scale||Standard Error|Least Squares Mean
116620|NCT00677807|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."||mmol/L||Standard Error|Least Squares Mean
116621|NCT00677807|Primary|Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52|The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|Weeks 12, 26, 36, 44 and 52|"Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment."||mmol/L||Standard Error|Least Squares Mean
116622|NCT00677807|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.~The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).~Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||participant|||Number
116623|NCT00677807|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.~A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||participants|||Number
116624|NCT00677807|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.~A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||participants|||Number
116625|NCT00677807|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.|Week 52|Participants from the Extension Intent-to-treat population (consisting of all participants who received at least one dose of study drug) for whom data was available for this Outcome Measure. Missing data was imputed Last Observation Carried Forward.||Liters||Standard Error|Least Squares Mean
116626|NCT00677807|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo|"The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment.~Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm.~High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm."|Up to 52 weeks|Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.||Participants|||Number
116627|NCT00677690|Secondary|Respiratory Function|forced expiratory volume in 1 second (FEV1)|5 weeks|||percentage of predicted value||Standard Deviation|Mean
116628|NCT00677690|Primary|Quadriceps Strength|Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.|5 weeks|||repetitions||Standard Deviation|Mean
116629|NCT00677690|Secondary|Quality of Life|St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).|5 weeks|||units on a scale||Standard Deviation|Mean
116630|NCT00677690|Primary|Exercise Capacity|6 minute walk test(6MWT)|5 weeks|||meters||Standard Deviation|Mean
116632|NCT00677534|Primary|Change in Monocyte VDR Expression With Vitamin D Therapy|Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.|Change from End of Washout to Week 12|Clinical pilot trial - proof of concept||units on a scale||Standard Deviation|Mean
116633|NCT00677365|Secondary|Changes in Susceptability Patterns of Isolated Organisms|All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value|from baseline until the end of the 28-day treatment period (28 days)|MITT||ug/mL|Participants||Number
116634|NCT00677365|Secondary|Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)|Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant|from baseline to the end of the 28-day treatment period (28 days)|MITT||units on a scale||Standard Error|Least Squares Mean
116635|NCT00677365|Secondary|Change in FEV1 Percent Predicted|Change in the predicted percent of air the patient could exhale in one second|from baseline to the end of the treatment 28-day treatment period (28 days)|MITT||Percent||Standard Error|Least Squares Mean
116636|NCT00677365|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|Percent change in the amount of air the patient could exhale in 1 second|from baseline to end of the 28-day treatment period (28 days)|MITT||Percent change||Standard Error|Least Squares Mean
116637|NCT00677365|Secondary|Time to Administration of Other Anti-pseudomonal Antimicrobials|Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported|from baseline until final study visit (up to 56 days)|MITT||days||95% Confidence Interval|Mean
116638|NCT00677365|Primary|Change in P. Aeruginosa Density|Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period|from baseline to end of treatment (28 days)|Modified Intent-to-Treat (MITT; patients who received at least one dose of study drug)||log10 CFU/g sputum||Standard Error|Least Squares Mean
116639|NCT00677352|Secondary|Percentage of Participants With Deterioration in Antidepressant Discontinuation Scale During Tapering Phase|The percentage of participants divided was calcurated as follows: Devide the number of participants who had experienced new symptoms in Week 16, regardless of causal relationship with the study drug, or worsening of the severity in Week 16 compared with Week 12, by total number of participants in each treatment group.|4 weeks|Completer Set : Subset of patients in the EES who had a PAS rating at Week 16.||Percentage of participants|||Number
116640|NCT00677352|Secondary|Summary of Adverse Events in Tapering Phase|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects were counted only once per treatment in each row.|4 weeks|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.||Participants|||Number
116641|NCT00677352|Secondary|Number of Participants With Summary of Adverse Events in Treatment Phase|Number of sparticipants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants were counted only once per treatment in each row.|1, 2, 4, 6, 8 10 and 12 weeks (or study discontinuation) after administration of study drug|The safety analysis set : Subset of patients who had taken at least one dose of the study drug and who had visited the study center at least once after taking the study drug.||Participants|||Number
116642|NCT00677352|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale Total Score at the End of Treatment Phase|"The Hamilton Anxiety Rating Scale provided a 5-point intensity rating (0=None to 4=Very severe) of anxiety symptoms in 14 items.~The increasing values are considered worse outcome. The total possible score is ranged from 0 to 52."|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"||Scores on a scale||Standard Deviation|Mean
116643|NCT00677352|Secondary|Mean Change From Baseline in Panic Attack at the End of Treatment Phase|Panic attacks were defined as having four or more of the following Diagnostic and Statistical Manual of Mental Disorders symptoms. Palpitations or increased heart rate, Sweating, Trembling or shaking, Shortness of breath or smothering sensations, Choking, Chest pain or discomfort, Nausea or upset stomach, Dizziness, unsteady feelings or faintness, Feeling unlike yourself, or detached from a situation and/or like things happening around you are strange and unreal, Fear of going crazy or doing something uncontrolled, Fear of dying, Abnormal sense, Hot flashes or chills.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"||panic attacks per week||Standard Deviation|Mean
116644|NCT00677352|Secondary|Percentage of Participants of Responder in Clinical Global Impression (CGI) - Improvement|"The ratings were rated to compare with baseline by 7-point  1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.~Responder was defined as number of participants who were assessed as very much improved or  much improved."|12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"||Percentage of participants|||Number
117407|NCT00669396|Secondary|Pregnancy|positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.|6 months|||participants|||Number
116645|NCT00677352|Primary|Mean Change From Baseline in Panic and Agoraphobia Scale (PAS) Total Score at the End of Treatment Phase|Panic and Agoraphobia Scale has 13 items with a 5-point scale (range: 0 to 4). The total possible score is ranged from 0 to 52. The increasing value are considered worse outcome. The scale is grouped into 5 subscores (not including item U in total score): panic attacks ; agoraphobia/avoidance behavior ; anticipatory anxiety; disability; and health worries. Four point difference in reduction of the PAS total score has been identified as not clinically meaningful in the assessment of Panic Disorder symptomatology.|Baseline and 12 weeks|"Efficacy Evaluable Set: A subset of patients in the Full Analysis Set who met some inclusion (diagnosis of Panic Disorder, etc.) and exclusion (psychotherapy, etc.) criteria, had to be treated for a minimum of 8 weeks and had a PAS score at least one evaluation during Week 8 to 12.~Last Observation Carried Forward"||Scores on scale||95% Confidence Interval|Least Squares Mean
116646|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 24 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|24 months follow-up|||proportion of participants||95% Confidence Interval|Number
116647|NCT00677235|Post-Hoc|Treatment Area Primary Patency (TAPP) at 12 Months.|TAPP is defined as patency (open to blood flow) after the study index procedure until reintervention in the treatment area (within 5mm proximal or 5mm distal to the study device or index balloon angioplasty treated area), or thrombotic occlusion that involved the treatment area.|12 months follow up|||proportion of participants||95% Confidence Interval|Number
116648|NCT00677235|Secondary|Post-intervention Secondary Patency at 6 Months|PSP (referred to as Access Circuit Cumulative Patency, ACCP, in the pivotal trial) at 6 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|6 month follow-up|||proportion of participants||95% Confidence Interval|Number
116649|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 6 Months|PAPP at 6 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|6 month follow up|||proportion of participants||95% Confidence Interval|Number
116650|NCT00677235|Secondary|Index of Patency Function (IPF) [the Average Number of Days Between Interventions] Rates of FLAIR™ and PTA at at 24 Months.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.|24 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.||Months||Standard Deviation|Least Squares Mean
116651|NCT00677235|Secondary|Post-intervention Secondary Patency at 24 Months|PSP (referred to as Access Circuit Cumulative Patency, ACCP, in the pivotal trial) at 24 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|24 months|||proportion of participants||95% Confidence Interval|Number
116652|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 24 Months|PAPP at 24 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|24 month follow up|||proportion of participants||95% Confidence Interval|Number
116653|NCT00677235|Secondary|To Estimate Safety at 24 Months.|To estimate the percentage of participants wihtout safety issues through 24 months.|24 months|||percentage of participants|||Number
116654|NCT00677235|Secondary|ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention at 24 Months. Procedure Until the Next Access Thrombosis or Reintervention.|To estimate proportion of patients patent at 24 months. ACPP was defined as the interval following the index procedure until the next access thrombosis or reintervention at 24 months.|24 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).||proportion of participants||95% Confidence Interval|Number
116655|NCT00677235|Secondary|Demonstrate Non-inferiority of FLAIR Safety in Terms of Serious Adverse Events at 12 Months|Serious Adverse Events at 12 months are reported for all 270 subjects.|12 months|||percentage of participants with serious|||Number
116656|NCT00677235|Secondary|Analysis of Proportion of Serious Adverse Events Classified as Device and/or Procedure-Related Through 30 Days Post-Procedure|The incidence of device-related and procedure-related serious adverse events (SAEs) from the index procedure through 30 days post procedure is summarized. The purpose of this analysis was to assess the effectiveness of the BPV clinician training program.|Patient Follow-Up|||events|||Number
116657|NCT00677235|Secondary|Procedural Success|Procedural success was a secondary endpoint without hypothesis testing and is therefore summarized descriptively. Procedural success is defined as anatomic success and at least one indicator of hemodynamic or clinical success.|Patient Follow-Up|||Percentage of Participants|||Number
116658|NCT00677235|Secondary|Post-intervention Secondary Patency at 12 Months|PSP (referred to as Access Circuit Cumulative Patency, ACCP, in the pivotal trial) at 12 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|12 months|||proportion of participants||95% Confidence Interval|Number
116659|NCT00677235|Secondary|Post-Intervention Assisted Primary Patency at 12 Months|PAPP at 12 months was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|12 months|||proportion of participants||95% Confidence Interval|Number
116660|NCT00677235|Secondary|To Assess the Number of Re-interventions to the Access Circuit Until Graft Abandonment or Through 12 Months Post-index Procedure|The estimated number of re-interventions to the access circuit until graft abandonment or through 12 months post-index procedure was a secondary endpoint without hypothesis testing and is therefore summarized descriptively.|Patient Follow-Up|||reinterventions||Standard Deviation|Mean
116661|NCT00677235|Primary|The Number of Participants With Device and/or Procedure Related Adverse Events at 12 Months Post Study Procedure.||12 months|||Number of Participants with Device and/o|||Number
116846|NCT00675584|Primary|Rate of Exacerbations Requiring Systemic Corticosteroids|The rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up|Measured at Month 12|Even if a child terminated prior to completion of the 12 months of follow-up, he/she contributed to the numrerator and denominator of the exacerbation rate||events per years of follow-up||Standard Error|Mean
116662|NCT00677235|Primary|The Index of Patency Function (IPF) [the Average Number of Days Between Interventions] of FLAIR™ is Not Inferior to That of PTA at 12 Months Post Study Procedure.|The IPF is summarized was defined as the time from the index study procedure to complete graft abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.|12 months|All patients who were enrolled in the study will participate in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).Blackwelder t-test testing non-inferiority of the FLAIR® group to that of PTA.||Months||Standard Deviation|Least Squares Mean
116663|NCT00677235|Primary|ACPP Was Defined as the Interval Following the Index Procedure Until the Next Access Thrombosis or Reintervention.|To demonstrate that the post intervention Access Circuit Primary Patency (ACPP) of FLAIR™ is superior to that of PTA at 12 months post study procedure.|12 months|All patients who were enrolled in the study were included in the analysis in the treatment group to which they were randomized, regardless of the intervention that they actually incurred (an intent-to-treat analysis).||proportion of participants||95% Confidence Interval|Number
116664|NCT00677014|Secondary|Secondary Endpoints Will Include Structural and Functional Measures||Chronic||||||
116665|NCT00677014|Primary|Left Ventricular End-systolic Volume (LVESV)|Change in square root of absolute left ventricular end systolic volume from baseline to 6 month follow up|6 months|Availability of baseline and 6 month echocardiograms with primary endpoint values (LVESV) among randomized patients||ml||Inter-Quartile Range|Median
116666|NCT00676806|Secondary|Incidence of Chronic GVHD||After Day +100|No subject receiving reduced intensity conditioning was evaluable for the event of chronic GVHD (0/3 subjects survived to day +100)||participants|||Number
116667|NCT00676806|Secondary|Infectious Complications in UCB Recipients.||Day +100|||participants|||Number
116668|NCT00676806|Secondary|Incidence of Acute GVHD||Day +100|||participants|||Number
116669|NCT00676806|Secondary|Proportion of Subjects With Platelet Engraftment|Proportion of patients engrafting by days +45, +90, and +180.|+45, 90, and 180 days|||participants|||Number
116670|NCT00676806|Primary|Number of Participants With Neutrophil Engraftment|Number of participants with neutrophil engraftment receiving umbilical cord blood for hematopoietic rescue following myeloablative or non-myeloablative conditioning|+45 and 90 days|Only 2 subjects were evaluable from each group at the +45 day mark. The same number were evaluable at the +90 day mark.||participants|||Number
116671|NCT00676793|Primary|Change in Serum HGF and Breast Cancer|Change in serum HGF from baseline to post Polyphenol E treatment.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.||pg/ml||Inter-Quartile Range|Median
116672|NCT00676793|Primary|Change in Serum VEGF in Breast Cancer|Change in serum VEGF from baseline to post treatment with polyphenon E.|Baseline and 4 to 6 weeks|Number of participants for analysis was determined per protocol.||pg/ml||Inter-Quartile Range|Median
116673|NCT00676780|Primary|Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.|Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|Number of participants for analysis was determined per protocol.||pg/mL||Inter-Quartile Range|Median
116674|NCT00676780|Primary|Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.|Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks.|The number of participants for analysis was determined per protocol.||pg/mL||Inter-Quartile Range|Median
116675|NCT00676780|Primary|Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer|Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.|Baseline and 6 weeks|The number of participants for analysis was determined per protocol.||ng/mL||Inter-Quartile Range|Median
116676|NCT00676689|Secondary|Functional Improvement|"Functional improvement at 6 months as defined by:~a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis."|6 months|Valve implant population. There were 2 screen failure patients and 10 patients where procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population. There were 11 additional patients for which data was not available for analysis, leaving 58 patients in this analysis.||participants|||Number
116677|NCT00676689|Secondary|Freedom From MACCE|Clinical Events Committee (CEC) adjudicated.|6 Months|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.||percentage of participants||95% Confidence Interval|Number
116678|NCT00676689|Primary|Freedom From Device or Procedure Related Death or Reintervention||1 year|Valve implant population. There were 2 screen failure patients and 10 patients where the procedure was started but the study valve not implanted, leaving 69 patients in the Valve Implant Population.||percentage of participants||95% Confidence Interval|Number
116679|NCT00676676|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Scale|the MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60 respectively (higher scores are more severe).|Baseline, 2-week, 8-week|This was a pilot protocol||units on a scale||Standard Deviation|Mean
116680|NCT00676650|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction."|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early|||||
116711|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116681|NCT00676650|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)|FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.|Baseline, every 4 weeks up to 123 weeks|Data not summarized, study terminated early|||||
116682|NCT00676650|Secondary|Change From Baseline in Pain Severity|Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.|Day 1 through Day 7 every 28 days (every cycle) up to 29 months|Data not summarized, study terminated early|||||
116683|NCT00676650|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response|Baseline, every 8 weeks up to 123 weeks|Data not summarized, study terminated early|||||
116684|NCT00676650|Secondary|Percent of Participants With Objective Response (OR)|OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.|Baseline, every 8 weeks up to 123 weeks|FA Population||percentage of participants||95% Confidence Interval|Number
116685|NCT00676650|Secondary|Progression-Free Survival (PFS)|PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02|Baseline, every 8 weeks up to 123 weeks|FA Population||weeks||95% Confidence Interval|Median
116686|NCT00676650|Primary|Overall Survival (OS)|OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.|Baseline up to 32 months|Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule.||months||95% Confidence Interval|Median
116687|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
116688|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
116689|NCT00676520|Secondary|SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
116725|NCT00676520|Secondary|Procedural Success||acute: post index procedure until hospital discharge|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants||95% Confidence Interval|Number
116690|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 1 year|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
116691|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at 180 days|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
116692|NCT00676520|Secondary|Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)|"SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease:~Anginal Stability: whether a patient’s symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient’s condition is hampering his ability to do what he wants to do.~Treatment Satisfaction: how well a patient understands her care and what she thinks of it.~Disease Perception: the overall impact of a patient’s condition on a patient’s interpersonal relationships and state of mind.~Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100."|at baseline|"First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||units on the SAQ scale||Standard Deviation|Mean
116693|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116694|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116695|NCT00676520|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116696|NCT00676520|Secondary|Dual Antiplatelet Therapy Non-compliance Through 1 Year|Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.|1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
116697|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 1 year|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
123903|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
116698|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 180 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
116699|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 30 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
116700|NCT00676520|Secondary|Dual Antiplatelet Medication Usage|"Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days.~Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel).~Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications."|at 14 days|Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.||percentage of participants|||Number
116701|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116702|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116703|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116704|NCT00676520|Secondary|Major Bleeding Complications|by TIMI flow|at 14 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116705|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116706|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116707|NCT00676520|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116708|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116709|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116710|NCT00676520|Secondary|Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116712|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116713|NCT00676520|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116714|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116715|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116716|NCT00676520|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116717|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116718|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116719|NCT00676520|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116720|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116721|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116722|NCT00676520|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116723|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 180 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116724|NCT00676520|Secondary|Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)|MI= Academic Research Consortium (ARC) defined|at 30 days|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
123904|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
116727|NCT00676520|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)|MI= ARC (Academic Research Constortium) defined|1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116728|NCT00676520|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).|"ARC Defines Stent Thrombosis in the following way:~Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria:~Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers~Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause~Possible Stent Thrombosis Any unexplained death beyond 30 days~For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1"|up to 1 year|"Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."||percentage of participants||95% Confidence Interval|Number
116729|NCT00676494|Primary|Major Adverse Events (MAEs) Within 30 Days|Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.|30 days|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||Participants|||Number
116730|NCT00676494|Secondary|Freedom From Target Lesion Revascularization (TLR) at 6 Months|Number of patients that did not require target lesion revascularization 6 months after index procedure.|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||participants|||Number
116731|NCT00676494|Secondary|Average Ankle Brachial Index (ABI) at 6 Months|Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||units on scale||Standard Deviation|Mean
116732|NCT00676494|Secondary|Average Rutherford Classification Score at 6 Months|Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)|6 months|Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.||Score on scale||Standard Deviation|Mean
116733|NCT00676455|Secondary|Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan.|"Tumor size will be measured by CT (by the MeVis Volumetry Software and correlated with on-going treatment plan.~Correlation of the tumor growth with clinical treatment will be assessed. Tumor size will be expressed in volume. Specifically Three dimensional volume Volume of Interest(VOI)will be calculated and correlated with the treatment protocol. Measure = tumor volume."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.|||||
116734|NCT00676455|Primary|This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions|"Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis.~Due to lack of participants. No significant findings are reported at this time."|As long as treatment is being assessed by CT examinations|Due to low enrollment no analysis was conducted due to the lack of participants.|||||
116735|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores|"Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment."|Baseline, Week 6|ITT; N = number of subjects in a treatment group.||participants|||Number
116736|NCT00676403|Secondary|Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, had baseline and post-baseline values.||scores on scale||Standard Error|Least Squares Mean
116847|NCT00675558|Secondary|Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area|Fatty acid uptake was expressed relative to adipocyte cell surface area [Vmax’(pmol/sec/µm^2) = Vmax/(cell surface area) X 10^8].|4 years|||pmol/sec/μm^2||Standard Deviation|Mean
116737|NCT00676403|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6|RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, and had baseline and post-baseline values.||scores on scales||Standard Error|Least Squares Mean
116738|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.|Week 1, Week 2, Week 4, Week 6|ITT||participants|||Number
116739|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116740|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116741|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116742|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.|Baseline,, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116743|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116744|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116745|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116746|NCT00676403|Secondary|Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline|MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 4, Week 6|ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116848|NCT00675558|Primary|Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake|The Vmax for facilitated Long Chain Fatty Acids (LCFA) uptake by omental adipocytes was measured.|4 years|||pmol/sec||Standard Deviation|Mean
116747|NCT00676403|Secondary|Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||scores on scale||Standard Error|Least Squares Mean
116748|NCT00676403|Secondary|Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.||minutes||Standard Error|Least Squares Mean
116749|NCT00676403|Secondary|Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit.||awakenings||Standard Error|Least Squares Mean
116750|NCT00676403|Secondary|Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.||hours||Standard Error|Least Squares Mean
116751|NCT00676403|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline|Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.||minutes||Standard Error|Least Squares Mean
116752|NCT00676403|Secondary|Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)|CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)|ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward.||participants|||Number
116753|NCT00676403|Secondary|Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|Week 6|ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating.||participants|||Number
116754|NCT00676403|Primary|Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6|IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.|Baseline, Week 6|ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment.||scores on scale||Standard Error|Least Squares Mean
116755|NCT00676364|Primary|Pain From Venipuncture|"Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. FACES in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain."|Pain was measured immediately after venipuncture.|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.||scores on a scale||Standard Deviation|Mean
116849|NCT00675558|Primary|Size of Adipocytes|The mean diameters of omental adipocytes were measured|4 years|||µm||Standard Deviation|Mean
116756|NCT00676364|Secondary|Anxiety of Venipuncture|Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here.|During venipuncture|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.||scores on a scale||Standard Deviation|Mean
116757|NCT00676338|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in Diastolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmHg||Standard Error|Least Squares Mean
116758|NCT00676338|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26.|Change in Systolic Blood Pressure from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmHg||Standard Error|Least Squares Mean
116759|NCT00676338|Secondary|Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events|Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.||events per subject-year||Standard Error|Mean
116760|NCT00676338|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 26|ITT population.||events per subject-year||Standard Error|Mean
116761|NCT00676338|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
116762|NCT00676338|Secondary|Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in Fasting HDL from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmol/L||Standard Error|Least Squares Mean
116763|NCT00676338|Secondary|Change in Fasting Total Cholesterol (TC) From Baseline to Week 26|Change in Fasting TC from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmol/L||Standard Error|Least Squares Mean
116764|NCT00676338|Secondary|Change in Body Weight From Baseline to Week 26|Change in Body Weight from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||kg||Standard Error|Least Squares Mean
116765|NCT00676338|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. All scheduled post-baseline measurements were included in the analysis, with no imputation of missing data other than that inherent in the MMRM model was used.||mmol/L||Standard Error|Least Squares Mean
116766|NCT00676338|Primary|Percentage of Patients Achieving HbA1c <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with baseline HbA1c >7%).|Baseline, Week 26|ITT subjects with baseline HbA1c>7%. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||percentage of patients|||Number
116767|NCT00676338|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|Intent to treat (ITT) population consisted of all randomized patients who had taken at least one dose of study drug. All scheduled post-baseline measurements were included in the analysis. Unscheduled visit observations were carried forward to the next scheduled visits.||percentage of total hemoglobin||Standard Error|Least Squares Mean
116781|NCT00676143|Secondary|Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score was <7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participant|||Number
116768|NCT00676208|Secondary|Change in Professionals' Attitudes About Diabetes|The University of Michigan's Research and Training Center's Diabetes Attitude Scale was used. There are 33 items and the response format is a 5 point Likert Scale ranging from 'strongly disagree'(1) to 'strongly agree'(5). A higher score means more positive attitudes toward diabetes and its treatment (e.g., psychosocial impact of diabetes; value of tight glucose control).The total score is computed by summing individual items and ranges from 0 to 165. Post-pre total scores were used with positive and higher values indicating greater favorable change.|Pre-intervention and Post-intervention at 1 month|||units on a scale||Standard Deviation|Mean
116769|NCT00676208|Primary|Change in Confidence in Ability to Perform Teamwork|A three item scale was used to assess confidence in ability to convey logic of recommendations to other providers, explain one's distinctive perspective, and be accountable to patients for a decision made by a colleague from another discipline. The responses for each item ranged from 'not at all confident' (0) to 'very confident' (4), with higher values indicating more confidence. The total scale ranged from 0 to 16 with higher being more confident. Difference scores were analyzed (post-pre) with positive and higher values indicating more favorable change.|Pre-intervention and Post-Intervention at 1 month|||units of a scale||Standard Deviation|Mean
116770|NCT00676182|Primary|Beck Depression Inventory Score (Total Score)|Range for Total Score: 0-63 Directionality: Higher score means more depression-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
116771|NCT00676182|Primary|Alcohol Use Disorders Identification Test (AUDIT) (Total Score)|Range for Total Score: 0-40 Directionality: Higher score means more alcohol use.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
116772|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Severity|Range for Total Score: 0 - 68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Only veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
116773|NCT00676182|Primary|Modified PTSD Symptom Scale: Self-Report - Frequency (Total Score)|Range for Total Score: 0-68 Directionality: Higher score means more PTSD-related symptoms.|Baseline, 6 Months, 12 Months|Veterans with TBI and comorbid PTSD with data at the specified time point were analyzed.||units on a scale||Standard Deviation|Mean
116774|NCT00676182|Primary|PTSD Checklist Military Form (PCL-M) (Total Score)|Range for total score: 17- 85 Directionality for total score: Higher score means experiencing more PTSD-related problems.|Baseline, 6 Months, 12 Months|Veterans with TBI with comorbid PTSD who were analyzed at the specified time point.||units on a scale||Standard Deviation|Mean
116775|NCT00676182|Primary|Patient Competency Rating Scale (PCRS) (Total Score)|Range for total score: 30 - 150 Directionality for total score: higher score means higher competency (can do things with greater ease)|Baseline, 6 Months, 12 Months|Only participants with data at the specified time were analyzed.||units on a scale||Standard Deviation|Mean
116776|NCT00676182|Primary|Craig Handicap Assessment and Reporting Technique (CHART)|"Ranges for Subscales: 0 - 100 Physical Independence: 4 -100 Cognitive Independence: 0 -100 Mobility: 0 -100 Occupation: 0 -100 Social Integration: 0 -100 Economic Self Sufficiency: 0-100~Directionality: for each subscale, higher score means more independence; lower score means needs more assistance."|Baseline, 6 Months, 12 Months|Only participants with data at the specified time points were analyzed.||units on a scale||Standard Deviation|Mean
116777|NCT00676182|Primary|Functional Independence MeasureTM (FIM)/Functional Assessment Measure (FAM) (Total Score)|Range: 30 - 210 FIMFAM Total Score: Higher value indicates higher function.|Baseline, 6 months, 12 months|Only participants with data at the specified time points are included in the analysis.||units on a scale||Standard Deviation|Mean
116778|NCT00676143|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
116779|NCT00676143|Secondary|Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participant|||Number
116780|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score of ≤ 0, ≤ 6, and ≤ 12 points. In order to calculate time to first median placebo deterioration in DAD, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the DAD total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the DAD total score of 7 points or more and the worsening is confirmed by the DAD assessment at the next non-missing visit.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants||95% Confidence Interval|Number
116844|NCT00675584|Secondary|Rate of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma||Measured at Month 12||||||
116845|NCT00675584|Secondary|Proportion of Episode-free Days||Measured at Month 12||||||
116782|NCT00676143|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)|Percentage of participants with worsening from baseline to Week 78 in ADAS-Cog/11 total score of ≤0, ≤3, and ≤7 points were reported. In order to calculate time to first median placebo deterioration in ADAS-Cog/11, the median change from baseline to Week 78 among the placebo participants of the mITT analysis population were determined. The median changes were used as the cutpoints for determining “deterioration” for Alzheimer’s disease participants in the study. If the median change from baseline to Week 78 in the ADAS-Cog/11 total score among the placebo participants of the mITT Analysis Population is 7 points, then the first median placebo deterioration is the first time where there is a worsening on the ADAS-Cog/11 total score of 7 points or more and the worsening is confirmed by the ADAS-Cog/11 assessment at the next non-missing visit.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants||95% Confidence Interval|Number
116783|NCT00676143|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Unit on a scale||Standard Error|Least Squares Mean
116784|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening) from baseline in DAD total score of >=12.|Baseline and 78 Weeks|||Days||95% Confidence Interval|Median
116785|NCT00676143|Secondary|Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)|The time to first median placebo deterioration was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
116786|NCT00676143|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
116787|NCT00676143|Secondary|Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration, defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of median time to first median placebo deterioration was presented.|Baseline and 78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
116788|NCT00676143|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. DAD total score range is 0 to 100; a positive treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Year||Standard Error|Least Squares Mean
116789|NCT00676143|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|Treatment differences are estimated using least-squares (LS) means with factor levels weighted according to overall analysis population proportions. ADAS-Cog/11 total score range is 0 (least impairment) to 70 (most impairment); a negative treatment difference (bapineuzumab minus placebo) favors bapineuzumab. Within the MMRMs for ADAS-Cog/11 described for the primary analyses, linear contrasts were formed to test increasing trend of the differences between bapineuzumab and placebo from Week 39 (the 9-month visit) through Week 78 (the 18 –month visit) for each variable, which is equivalent to testing a positive slope of the differences between each bapineuzumab dose group and placebo from Week 39 through Week 78. Results are from a restricted maximum likelihood (REML)-based mixed model for MMRM.|Week 39 to Week 78|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Year||Standard Error|Least Squares Mean
116790|NCT00676143|Secondary|Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71|Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|Baseline and 71 Weeks|vMRI population included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.||Milliliter (mL)/year||Standard Error|Least Squares Mean
116791|NCT00676143|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71|Biomarkers CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|Baseline and 71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).||pg/mL||Standard Error|Least Squares Mean
116792|NCT00676143|Secondary|Change From Baseline in Brain Amyloid Burden at Week 71|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PIB) positron emission tomography (PET). The latter is a semi-quantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer’s pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|Baseline and 71 weeks|PIB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one postbaseline PIB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI ≥1.35 at baseline.||standard uptake value ratio||Standard Error|Least Squares Mean
116793|NCT00676143|Primary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78|"The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant.~This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement."|Baseline and 78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Unit on a scale||Standard Deviation|Least Squares Mean
116794|NCT00676143|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78|"The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.~This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced.~The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment."|Baseline and 78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.||Unit on a scale||Standard Error|Least Squares Mean
116795|NCT00676130|Secondary|Progression to Abscess|Proportion of subjects in each arm with progression from cellulitis to abscess.|12 +/- 2 days, 30 days +/- 2 days|||participants|||Number
116796|NCT00676130|Primary|Relative Efficacy|"Proportion of subjects in each arm with successful treatment.~Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days."|12 +/- 2 days; 30 +/- 2 days|Of the 153 randomized subjects, 4 were randomized in error and did not receive study drug, 1 received two doses before it was discovered that he was ineligible, 1 was lost to follow up, and 1 withdrew voluntarily in the first few days after enrollment. This left 146 subjects for intent-to-treat analysis.||participants|||Number
116797|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116798|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116850|NCT00675506|Secondary|Mitochondrial Function by 31P-MRS|Analysis ongoing, no data available currently.|Measured at Baseline and Months 6 and 12||||||
116851|NCT00675506|Secondary|Change in Growth Hormone Pulse Characteristics as Assessed by Overnight Frequent Sampling of Growth Hormone|Analysis ongoing, no data available currently.|Measured at baseline and Month 12||||||
116799|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116800|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116801|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116802|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116803|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116804|NCT00676091|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
116805|NCT00676091|Secondary|Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
116806|NCT00676091|Secondary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
116807|NCT00676091|Primary|Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
116808|NCT00676091|Primary|Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
116809|NCT00676065|Primary|Breast Cancer|Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
116810|NCT00676065|Primary|Venous Thromboembolism|Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
116811|NCT00676065|Primary|Arterial Thromboembolism|Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.|Within 10 years|The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
116812|NCT00675987|Primary|Insulin Sensitivity Utilizing Endothelial Function as Assessed by Pulse Volume Amplitude|Endothelial function assessed as the ratio of pulse volume amplitude after compared with before a reactive hyperemia stimulus, measured by peripheral (fingertip) arterial tonometry. Reported values indicate the percentage change from Baseline in the ratio of pulse volume amplitude after compared to before the reactive hyperemia stimulus.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were exlcuded)||percentage change||Standard Deviation|Mean
116813|NCT00675987|Secondary|To Assess the Change From Baseline Cytokines, Markers of Inflammation, and Markers of Oxidative Stress After 8 Weeks of Treatment. Also to Assess the Effect on Microalbuminuria After 8 Weeks of Treatment.||baseline, 8 weeks||||||
116814|NCT00675987|Primary|Insulin Sensitivity Utilizing the Euglycemic Hyperinsulinemic Clamp|Insulin clamp derived insulin sensitivity, as insulin stimulated glucose disposal corrected for steady state insulin level.|baseline, 8 weeks|analysis was ITT, but limited to those with interpretable data (3 clamp studies were exlcuded)||mg/kg/min||Standard Deviation|Mean
116815|NCT00675948|Secondary|Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment|The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all randomised subjects who received at least one dose of study medication and who yielded on-treatment efficacy data.||units on a scale||Standard Deviation|Mean
116816|NCT00675948|Secondary|Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.|0 - 657 days|The efficacy analyses were conducted on data from all subjects who entered the study, who were randomised, who received at least one dose of study medication and who yielded on-treatment efficacy data||units on a scale||Standard Deviation|Mean
116817|NCT00675948|Primary|The Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event in this study is presented.|0 - 657 days|All subjects who took at least one dose of study medication and yielded on-treatment efficacy data were classed as the safety population.||participants|||Number
116818|NCT00675922|Secondary|Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients||Admission to burn unit to discharge||||||
116819|NCT00675922|Primary|Infection Rate|Percent of infections following antimicrobial topical treatment with Sulfamylon vs Silver Nitrate Soaks.|Acute hospitalization following burn injury: admission to discharge (1-20 weeks)|Percent of sites treated with sulfamylon of Silver Nitrate soaks that developed infections||percentage of participants|||Number
116820|NCT00675909|Secondary|Respiratory Rate||Every 5 minutes during ED visit||||||
116821|NCT00675909|Secondary|Heart Rate||Every 5 minutes during ED visit||||||
116822|NCT00675909|Secondary|Oxygen Saturation||During entire ED visit||||||
116823|NCT00675909|Secondary|Anxiety||Every 5 minutes during ED visit||||||
116824|NCT00675909|Primary|Safety||During entire ED visit||||||
116825|NCT00675909|Primary|Caregiver and Parental Satisfaction||At end of procedure for caregiver and follow up phone call for parent||||||
116826|NCT00675909|Primary|Length of Stay||Minutes of ED stay||||||
116827|NCT00675909|Primary|Change in CHEOPS Score Measured Level of Sedation From Baseline (Presentation in ED, Before Sedation) to Start of Procedure (Laceration Repair).|"Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)assessment used to score sedation.~Scale range is 0-10 with 0 meaning no pain and 4 or greater meaning pain. Scale is determined by assessing Facial Expression (0-2), Cry (0-3), Child Verbal (0-2) and Movements (0-3)."|Baseline (presentation, before sedation) in ED to start of procedure (laceration repair).|Intention to treat||Scores on a scale||95% Confidence Interval|Median
117162|NCT00672555|Secondary|Minor Complications (Wound Complications)|All wound complications were assessed; part of them being only very minor dehiscences or slight infections. They were assessed in the outpatients clinic at 3 Weeks and in the follow-up control initiated at 1 year. All patients suffering from a wound complication that occurred in the first year were counted.|1 year|||participants|||Number
116828|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.7, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||Minutes||Standard Deviation|Mean
116829|NCT00675792|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.8, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||Minutes||Standard Deviation|Mean
116830|NCT00675792|Secondary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.9, with imputed data included.|Up to 1 hour after treatment|ITT group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||Minutes||Standard Deviation|Mean
116831|NCT00675792|Secondary|Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide|Evidence of adverse events due to a possible interaction of sugammadex with exogenous compounds or endogenous compounds other than rocuronium was recorded.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine||participants|||Number
116832|NCT00675792|Secondary|Number of Participants With Post-operative Complications|Post-operative complications include any of the following: procedural pain, nausea, vomiting, incision-site pain, constipation, headache, pyrexia, dizziness and pruritus.|Up to 7 days after surgery|All subjects treated (AST) group consisting of randomized participants who were treated with sugammadex or neostigmine||participants|||Number
116833|NCT00675792|Primary|Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation|Neuromuscular function was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds, and assessing twitch response at the adductor pollicis muscle with a TOF-Watch® SX. The magnitudes (heights) of the first and fourth twitches (T1 and T4) were used to calculate the T4/T1 ratio, where a higher T4/T1 ratio indicates a greater recovery from neuromuscular blockade, with a value of 1.0 indicating complete recovery. After anesthesia, when neuromuscular function was expected to be fully recovered, tracheal extubation was performed, at which time the T4/T1 ratio was measured, with any missing recovery times imputed.|Up to the first 24 hours after tracheal extubation|Intent to treat (ITT) group consisting of all randomized participants who were treated with sugammadex or neostigmine and had at least one efficacy measurement. Three participants treated with neostigmine did not have at least one efficacy measurement, and hence were excluded from the analysis.||T4/T1 Ratio||Standard Deviation|Mean
116834|NCT00675766|Primary|Neuropsychological Status (i.e., Cognitive Functioning)|Neurocognitive functions refer to cognitive abilities, namely learning/memory, motor speed, psychomotor speed, language, attention, visuospatial abilities, & executive function. They are measured using standard clinical neuropsychological test battery that included: HVLT, BVMT-R, Trails A & B, WCST-64, WAIS-Symbol Search/Digit Coding/Letter-Number Sequencing/Block Design, FAS, & Animals. Subgroups of these tasks were combined to create composite scores indicating participants' score on each cognitive domains. To make these cognitive domain composite scores, each participant's raw score on each of these tests was converted into a within-sample standardized score (i.e., z-score), which are normally distributed with a mean of 0 & SD of 1. Then, these standardized scores were summed to create composite scores for each cognitive domain and then averaged to create a global neuropsychological function composite score. A positive composite score represents a better outcome for all variables.|Baseline (Year 1) and 1-year follow-up (Year 2)|HIV+ and HIV negative men who were evaluated BOTH at baseline and Year 2. Those participants who were evaluated at Baseline but not at Year 2 were excluded from analyses.||z-score composites of cognitive domains||Standard Error|Mean
116835|NCT00675597|Primary|To Measure the Number of Cycles|Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.|2 years|||participants|||Number
116836|NCT00675584|Secondary|Caregiver Quality of Life||Measured at Month 12||||||
116837|NCT00675584|Secondary|Symptom Severity During Respiratory Tract Illness||Measured at 7 days for each respiratory tract illness||||||
116838|NCT00675584|Secondary|Rate of Rescue Albuterol Use||Measured at Month 12||||||
116839|NCT00675584|Secondary|Absences From Daycare and Preschool for the Child and From Work for the Caregiver||Measured at Month 12||||||
116840|NCT00675584|Secondary|Adverse Events Associated With Corticosteroid Use||Measured at Month 12||||||
116841|NCT00675584|Secondary|Changes in Pulmonary Reactance and Resistance||Measured at Month 12||||||
116842|NCT00675584|Secondary|Changes in Exhaled Nitric Oxide Levels||Measured at Month 12||||||
116843|NCT00675584|Secondary|Time to Treatment Failure||Measured at Month 12||||||
116852|NCT00675506|Secondary|Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test|Glucose tolerance was determined after an overnight fast using standard 75 gram oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Change in glucose tolerance (fasting and 2 hour OGTT) between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||mg/dL||Standard Error|Mean
116853|NCT00675506|Secondary|Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)|Lipid Profile (total cholesterol, high-density lipoproteins [HDL] cholesterol, low-density lipoproteins [LDL] cholesterol, triglycerides)was determined after an overnight fast. The change in lipid profile between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||mg/dL||Standard Error|Mean
116854|NCT00675506|Secondary|Change in Carotid Intima-media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||mm||Standard Error|Mean
116855|NCT00675506|Primary|Change in Visceral Adipose Tissue Volume|Abdominal visceral adipose tissue and subcutaneous adipose tissue were assessed using a single crosssectional slice from noncontrast computed tomography at the L4 level. The change in abdominal visceral adiposity between baseline and twelve months is reported.|Measured at baseline and Months 6 and 12|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.||cm2||Standard Error|Mean
116856|NCT00675441|Primary|Number of Participants' With Treatment Response of Complete or Partial Response|Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk and grip strength.|Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.|Of the five (5) participants enrolled, two participants were taken off study after only a few days of therapy and one participant expired, all three of which were not evaluable for response.||participants|||Number
116857|NCT00675428|Secondary|Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)||Cycle 1: Day 1 (1 hour before infusion and 1 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: 1 hour before and 1 hour after infusion). Cycle 6: Day 1 (1 hour before infusion and 1 hour after infusion), Days 8, 15, 22.|Analysis of binding saturation of α4 integrin sites was not performed because the study was terminated early.|||||
116858|NCT00675428|Secondary|Pharmacokinetic (PK) Profile Of Natalizumab|PK modeling, either compartmental or noncompartmental-based, was used to describe serum concentrations. Standard PK parameters estimated include: area-under-the-concentration-time curve (AUC), maximum-observed concentration (Cmax), time-to-reach maximum concentration (Tmax), total body clearance (Cl), volume of distribution (Vd), and elimination half-life (t1/2).|Cycles 1 and 6: Day 1 (before infusion and 0.25, 2, 6 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: Day 1 (before infusion and 0.25 hour after infusion)|PK analysis was not performed because the study was terminated early.|||||
116859|NCT00675428|Secondary|Kaplan-Meier Estimates for Duration Of Response For Participants With A Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Kaplan-Meier methods were used to estimate the median duration of response and associated 95% confidence intervals.|Day 1 up to Month 6|Duration of response was not calculated because the study was terminated early.|||||
116860|NCT00675428|Secondary|Number Of Participants Who Achieve A Complete Response|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Complete Response (CR): negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas , and ≤ 5% plasma cells in the bone marrow. Stringent CR (sCR): CR as defined above, and normal free light chain (FLC) ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence, based on a κ/λ ratio of > 4:1 or < 1:2 performed on a minimum of 100 plasma cells.|Day 1 up to Month 6|||participants|||Number
116861|NCT00675428|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered medicinal (investigational) product and that does not necessarily have a causal relationship with this product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See the adverse events section of the record for more details.|Day 1 up to Month 6|||participants|||Number
116862|NCT00675428|Primary|Objective Response Rate (ORR)|Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006).|Day 1 up to Month 6|ORR was not calculated because the study was terminated early.|||||
116889|NCT00674661|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months|||diopters||Standard Deviation|Mean
116863|NCT00675428|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs = any ≥grade 3 toxicity related to treatment; treatment delays of ≥7 days due to any toxicity related to treatment, with the exception of hepatic transaminases; or alanine and/or aspartate aminotransferase (ALT and/or AST) >3*upper limit of normal (ULN) with either a total bilirubin >2*ULN or an international normalized ratio (INR) >1.5 related to treatment, or with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia.|Day 1 up to Day 28|||participants|||Number
116864|NCT00675259|Secondary|Overall Expression of LZTS1 Before and After Neoadjuvant Therapy as Assessed by Immunohistochemistry|LZTS1 expression in breast cancer cells collected prior to NCT|prior to surgery|LZTS1 expression in breast cancer cells collected prior to NCT was assessed in 27 patients who had evaluable core biopsies.||patients|||Number
116865|NCT00675259|Secondary|Evaluation of Dynamic Contrast-enhanced Magnetic Resonance Imaging in Assessing pCR at Baseline and After 2 Cycles of Neoadjuvant Therapy|Relative angiogenic volume (AV) was defined as the ratio of AV to the geometric volume of the tumor in the breast.|after 2 cycles of therapy|Data only available for 20 of the 28 evaluable patients||ratio||Standard Deviation|Mean
116866|NCT00675259|Primary|Side Effects of Weekly Nab-paclitaxel, Carboplatin and Bevacizumab|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0|Up to 4 weeks|all grade 3 adverse events||patients|||Number
116867|NCT00675259|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR was defined as the absence of viable invasive tumor cells in the surgical breast specimen and axillary lymph nodes.|every 4 weeks|Includes patients with triple negative breast cancer and ER+/PR+ breast cancer.||patients|||Number
116868|NCT00675103|Secondary|Mean Plasma Uric Acid|This endpoint assessed the change in mean PUA concentration from baseline after the first dose and after the third dose. Mean PUA was calculated from samples collected at 5 timepoints following each of those doses. For example, Mean PUA at Week 3 included 5 timepoints before dose 2 infusion.|Baseline, Week 3 and Week 7|ITT population||mg/dL||Standard Deviation|Mean
116869|NCT00675103|Primary|Adverse Event Profile|Number of participants reporting events|6 months|||Number of participants|||Number
116870|NCT00674986|Secondary|Glycemic Variability Pre and Post-Prandial Excursions at Each Meal|"Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion.~The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects."|Month 1, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||mg/dL||Standard Error|Least Squares Mean
116871|NCT00674986|Secondary|Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day|SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period.|12 Months|Intent to treat population included all enrolled participants who completed the baseline training visit.||Tests/day||Standard Error|Least Squares Mean
116872|NCT00674986|Secondary|Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)|Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Per protocol population included all enrolled participants who completed the baseline training visit, completed at least 4 of 5 clinical visits, and had evaluable HbA1c data at Month 12. The Structured Testing Group also had to have at least 80% of the blood glucose values.||Score on a scale||Standard Error|Least Squares Mean
116873|NCT00674986|Secondary|Change From Baseline in the World Health Organization (WHO-5) Well-being Index|Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Score on a scale||Standard Error|Least Squares Mean
116874|NCT00674986|Secondary|Change From Baseline in the Diabetes Distress Scale (DDS)|Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Score on a scale||Standard Error|Least Squares Mean
116875|NCT00674986|Secondary|Change From Baseline in Depression Severity (PHQ-8)|The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Score on a scale||Standard Error|Least Squares Mean
116957|NCT00673881|Secondary|Endogenous Bile Acid Excretion|Change in endogenous bile acid excretion from baseline to end-of-treatment|12 weeks||||||
116958|NCT00673881|Secondary|Neutral Sterol Endogenous Excretion|Change in neutral sterol endogenous excretion from baseline to end-of-treatment|12 weeks||||||
116876|NCT00674986|Secondary|Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations|Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.)|12 Months|Intent to treat population included all enrolled participants who completed the Baseline training visit. Participants who dropped out before Month 1 visit were not included in the analysis.||Visits||Standard Deviation|Mean
116877|NCT00674986|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12|Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Month 12|Intent to treat population included all enrolled participants who completed the baseline training visit.||Percent||Standard Error|Least Squares Mean
116878|NCT00674973|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment, regardless of whether or not the event had a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Up to 28 days after discontinuation of study drug (up to 30 months)|Safety population included all participants who received at least 1 dose of study medication and had a safety follow-up, whether withdrawn prematurely or not, were included in the safety population.||participants|||Number
116879|NCT00674973|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, regardless of the cause of death.|From the time of randomization until or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||months||95% Confidence Interval|Median
116880|NCT00674973|Secondary|Percentage of Participants With Disease Control Rate (DCR)|Disease control rates (DCR) were measured according to RECIST Version 1.0 criteria. Disease control was defined as being a responder or as having stable disease for at least 6 weeks post-randomization. Stable disease was defined as having neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
116881|NCT00674973|Secondary|Percentage of Participants With Best Overall Response Rate|Response rate was defined as Complete Response (CR) or Partial Response (PR), according to response evaluation criteria in solid tumors (RECIST) Version 1.0 criteria, for at least 4 weeks at any time during randomized treatment (confirmed response). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|From the time of randomization until progression of disease or death (up to 30 months)|The FAS was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
116882|NCT00674973|Primary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first occurrence of PD or death whichever occurred first. Participants without event were censored at the date of last tumor assessment where non-progression was documented. Analysis was performed using Kaplan-Meier method.|From the time of randomization until progression of disease or death (up to 30 months)|The Full-Analysis Set (FAS) was defined as all randomized patients. Participants were presented according to the therapy that they were randomized to receive.||weeks||95% Confidence Interval|Median
116883|NCT00674765|Primary|TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase|The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm.|12 weeks|||percent days of heavy drinking|||Number
116884|NCT00674739|Secondary|Treatment Related Adverse Events|Numbers of subjects in each treatment group reporting one or more adverse events|Up to 16 weeks|Patients with adverse events considered probably related or related to the administration of the product.||Participants|||Number
116885|NCT00674739|Primary|Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study|Proportion of subjects with complete clearance of all warts (both presented at Baseline and newly emerged warts) at End of Study. Primary analysis performed on the Intent to Treat population with imputation (Last Observation Carried Forward)for missing data points.|Up to 16 weeks|Intention to treat||participants||95% Confidence Interval|Number
116886|NCT00674739|Secondary|Safety Variables Include Adverse Reactions (AEs), Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period.|"Local skin reactions in the treatment and/or immediate surrounding area were clinically identified as: erythema, edema, weeping/exudate, flaking/scaling/dryness, and erosion/ulceration. LSRs were visually assessed by investigator at each visit.~Rest period was a temporary interruption of dosing dur to intolerable LSRs."|Up to 16 weeks|||participants|||Number
116887|NCT00674700|Secondary|Average Rhinitis Total Symptom Score (ARTSS)|The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
116888|NCT00674700|Primary|Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period|"The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).~It ranges from 0 to 12, the higher the score the more severe the rhinitis."|Last 3 months of Year 1|The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.||Units on a scale (range: 0 to 12)||Standard Error|Least Squares Mean
116890|NCT00674622|Secondary|Pain Threshold on Dolorimetry|Pressure pain threshold (PPT) has been noted to correlate with pain and disability associated with LE. PPT was determined by applying pressure with a digital algometer over the area of maximal tenderness corresponding with the common extensor tendon area. Only 1 determination was obtained as the 1st application of pressure can lower the pain threshold for subsequent testing.|6 and 12 weeks post-intervention|||Pounds||Standard Deviation|Mean
116891|NCT00674622|Secondary|Nirschl Pain Phase Scale|The Nirschl Pain Phase Scale (NPPS), which has been used to describe functional impairment related to tendinopathies such as lateral epicondylitis. This scale provides a global rating of impairment associated with sports and musculoskeletal injuries. A rating from 0-7 describes the phase of overuse injuries, with Phase 0 noting “No stiffness or soreness after activity” and Phase 7 corresponding with “Pain that also disrupts sleep consistently. Pain is aching in nature and intensifies with activity”. It was used as an indication of severity for entry into the study and as the criterion for treatment response.|6 and 12 weeks post-intervention|||units on a scale||Standard Deviation|Mean
116892|NCT00674622|Secondary|Grip Strength|Maximal pain-free grip strength has been used as a physical correlate of disability associated with LE. Grip strength was obtained using a Jamar Dynamometer set in the 2nd position. 3 trials were recorded and the average pain-free grip strength was noted.|6 weeks and 12 weeks post-intervention|||pounds||Standard Deviation|Mean
116893|NCT00674622|Secondary|QuickDASH|The QuickDASH is an abbreviated form of the rating scale DASH or Disabilities of the Arm, Shoulder, & Hand. This is a self-report rating of function for individuals with problems of the upper extremity. The Institute for Work and Health, in collaboration with the American Academy of Orthopaedic Surgeons developed a self-report questionnaire “Disabilities of the Arm, Shoulder, & Hand”. It is seen as a valid and reliable measure of upper extremity functional impairment, is in widespread use in the States and abroad, having been translated into multiple languages and has been used for studies on LE. 11 items are scored on this self-rating instrument on a 1-5 Likert scale with higher score reflecting greater disability. The scores are averaged and then converted to a 100 point scale (0-100), with higher score reflecting greater disability.|6 weeks and 12 weeks post-intervention|||units on a scale||Standard Deviation|Mean
116894|NCT00674622|Primary|McGill Pain Questionnaire|This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.|6 weeks and 12 weeks post intervention|||units on a scale||Standard Deviation|Mean
116895|NCT00674609|Primary|The Consumption of Escape Analgesic Medication.|Subjects recorded their use of escape medication each day on their diary card.|2 weeks: baseline - end of week 2 (last 3 days of treatment)|The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.||tablets per day||Standard Deviation|Mean
116896|NCT00674609|Secondary|Brief Pain Inventory Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|End of 2 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
116897|NCT00674609|Secondary|EORTC Quality of Life Questionnaire (EORTC-QLQC30)|Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100|2 weeks; baseline and end of treatment (2 weeks)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
116898|NCT00674609|Secondary|Concentration 0-10 Numerical Rating Scale|"The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper? where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
116899|NCT00674609|Secondary|Appetite 0-10 Numerical Rating Scale|"The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your appetite has been throughout the day? where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
116900|NCT00674609|Secondary|Memory 0-10 Numerical Rating Scale|"The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours? where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
116901|NCT00674609|Secondary|Nausea 0-10 Numerical Rating Scale|"The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how sick you felt throughout the day? where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline."|2 weeks; baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
116902|NCT00674609|Secondary|Sleep Disturbance 0-10 Numerical Rating Scale|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|2 weeks: baseline to end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.||units on a scale||Standard Deviation|Mean
116903|NCT00674609|Primary|The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.|"The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|2 weeks: baseline - end of week 2 (last 3 days of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.||units on a scale||Standard Deviation|Mean
116904|NCT00674492|Primary|Attributes of Treatment Experience|Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior.|Zero to five years since ending treatment.|||participants|||Number
116905|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
116906|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
116907|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
116908|NCT00674362|Other Pre-specified|Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
116909|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
116910|NCT00674362|Other Pre-specified|Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24|The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).|Week 24|Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.||Kappa Correlation Coefficient||95% Confidence Interval|Number
116911|NCT00674362|Other Pre-specified|Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits|Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.|From Week 24 up to Week 52|"All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.~An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results."||days||Standard Error|Mean
116912|NCT00674362|Secondary|Change From Baseline in Fatigue Assessment Scale at Week 24|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method||units on a scale||Standard Deviation|Mean
116913|NCT00674362|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method||mm||Standard Deviation|Mean
116959|NCT00673881|Secondary|Change in Bile Acid Excretion|Change in bile acid excretion from baseline to end-of-treatment|Baseline to 12 weeks||||||
116914|NCT00674362|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method||mm||Standard Deviation|Mean
116915|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116916|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116917|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116918|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116919|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116920|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116921|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116922|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116923|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116924|NCT00674362|Secondary|Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement.|Baseline, Week 24|Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.||units on a scale||Standard Deviation|Mean
116960|NCT00673881|Secondary|Change in Neutral Sterol Excretion|The excretion rate of fecal neutral and acidic sterols was measured as mg/day, for each individual three times during the 10 day period following the isotope infusions at baseline and end-of-treatment.|baseline to 12 weeks||||||
116925|NCT00674362|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from Baseline is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 24|Of the 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
116926|NCT00674362|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 24|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
116927|NCT00674362|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 24|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
116928|NCT00674362|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
116929|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits|DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||Days||Standard Deviation|Mean
116930|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI >3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||days||Standard Deviation|Mean
116931|NCT00674362|Secondary|Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI >2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.|Week 24 up to Week 52|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||days||Standard Deviation|Mean
116932|NCT00674362|Secondary|Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
116933|NCT00674362|Secondary|28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24|DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|Since imputation was used, all 194 subjects are included in the analysis||percentage of subjects|||Number
116961|NCT00673881|Secondary|Percent Change in de Novo Cholesterol Synthesis|Plasma DNC was measured three times from blood draws on the 3 visits in the 10 day period following the isotope infusion at baseline and again at end-of-treatment at 12 weeks, and expressed in percent. Change from baseline to end-of-treatment expressed as percent.|Baseline to 12 weeks||||||
116934|NCT00674362|Primary|Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)|Week 20 and Week 24|All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.||percentage of subjects|||Number
116935|NCT00674323|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.||Letters||Standard Deviation|Mean
116936|NCT00674323|Secondary|Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)|High resolution 6 meridian scans were performed to measure central retinal thickness.|Baseline and Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.||micrometers||Standard Deviation|Mean
116937|NCT00674323|Secondary|Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Baseline through end of study (6 months)|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.||Participants|||Number
116938|NCT00674323|Primary|Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)|Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.|Month 6|Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.||Participants|||Number
116939|NCT00674206|Secondary|Overall Survival From Time of Study Entry|"The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived.~Note: Not all patients started the study at the same time so the time frame is different from the full range.~The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived."|132 weeks|||Weeks||Full Range|Median
116940|NCT00674206|Primary|Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.|"A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions.~Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|8 weeks|||participants|||Number
116941|NCT00674154|Secondary|Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm||one year||||||
116942|NCT00674154|Secondary|Increased Bone Mineral Density||One year||||||
116943|NCT00674154|Secondary|Increase in Quality of Life||One year||||||
116944|NCT00674154|Secondary|Reduced Postoperative Hypocalcemia||Postoperative week||||||
116945|NCT00674154|Secondary|Improved Muscular Function||One Year||||||
116946|NCT00674154|Primary|Decrease in Preoperative P-PTH|Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.|25 weeks|||pmol/l||Standard Error|Mean
116947|NCT00674128|Primary|Reported Here Are the Number of Participants With Devices That Developed Infection||Within 3 months after surgery.|||participants|||Number
116948|NCT00674115|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days|25 participants in each arm had good quality tracings and were included in the efficacy analysis.||pH scale||Full Range|Median
116949|NCT00673959|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|upon instillation|||Units on a scale||Standard Deviation|Mean
116950|NCT00673933|Secondary|Erythema Score (Mild and Moderate)1 Day After First Treatment|Patients with mild or moderate erythema 1 day after first treatment.|1 day after 1st treatment and baseline|ITT||percentage of participants|||Number
116951|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After Second Treatment|Patients with mild or moderate erythema after second treatment.|Immediately after second treatment, 2 weeks after baseline|ITT||percentage of participants|||Number
116952|NCT00673933|Secondary|Change in Noninflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT||lesion count||Standard Deviation|Mean
116953|NCT00673933|Secondary|Change in Inflammatory Lesion Counts From Baseline||4 weeks after last treatment, 6 weeks after baseline|ITT||lesion count||Standard Deviation|Mean
116954|NCT00673933|Secondary|Erythema Score (Mild and Moderate)Immediately After First PDT|Patients with mild or moderate erythema after first treatment at baseline.|Immediately after treatment at baseline|ITT||percentage of participants|||Number
116955|NCT00673933|Primary|Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment||4 weeks after last treatment, 6 weeks after baseline|||participants|||Number
116956|NCT00673881|Primary|Total Cholesterol|Mean Change in total cholesterol from baseline to End-of-treatment (Day 95)|12 weeks|||mg/dL||Standard Deviation|Mean
116963|NCT00673881|Secondary|Plasma Cholesterol Efflux|Change in efflux rate from baseline to end-of-treatment. The efflux rate of cholesterol from peripheral tissues into the plasma was measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® or Liposyn® and 10 % ethanol was given piggy-backed into normal saline over 24 hours. This was used to determine rate of appearance (Ra) cholesterol, measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol traced into biliary sterols.|12 weeks||||||
116964|NCT00673881|Primary|Mean Change in High Density Lipoprotein Cholesterol|Mean change in plasma high density plasma lipoprotein cholesterol (HDL-C)baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|Baseline to 12 weeks|||mg/dL||Standard Deviation|Mean
116965|NCT00673881|Primary|Mean Change in Plasma Triglycerides|Change in plasma triglyceride, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,Day 95)|baseline to 12 weeks|per protocol||mg/dL||Standard Deviation|Mean
116966|NCT00673881|Primary|Mean Change in Calculated Low Density Lipoprotein Cholesterol|Mean change in calculated LDL, baseline (average Day 0, 1 10) to end-of-treatment (12 weeks treatment,average Day 95)|baseline to 12 weeks|||mg/dL||Standard Deviation|Mean
116967|NCT00673855|Primary|Drop Comfort Upon Instillation|Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.|Three minutes|||Units on a scale||Standard Deviation|Mean
116968|NCT00673816|Secondary|Change in Retinal Angioma Leakage From Baseline to Week 36|"Leakage of the retinal angioma was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume."|Baseline and 36 Weeks||||||
116969|NCT00673816|Secondary|Change in Retinal Thickness From Baseline to Week 36|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 36 Weeks|||µm|||Number
116970|NCT00673816|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 36 Weeks|||ETDRS Letters|||Number
116971|NCT00673764|Secondary|Functional Blink Rate Time (Time Between Blinks)|Measures time in seconds between normal blinks. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Longer blink rate time correlates with improved visual performance.|15 minutes, 45 minutes, and 90 minutes post-dose|||seconds||Standard Deviation|Mean
116972|NCT00673764|Primary|Time at Best Corrected Visual Acuity|Measuring length of time patient can maintain their best vision while completing a computer task. Performed at 15 minutes, 45 minutes, and 90 minutes post-dose. Corrected visual acuity means the patient can wear glasses or contacts if needed such that the measure is performed with the patient seeing the best that they can.|15 minutes, 45 minutes, and 90 minutes post-dose|||seconds||Standard Error|Median
116973|NCT00673738|Secondary|Overall Response Rate (ORR)|ORR = Complete Response (CR) + Partial Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response: Disappearance of all target lesions; Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 36 months|All participants||percentage of participants||95% Confidence Interval|Number
116974|NCT00673738|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from randomization until death from any cause.|Up to 36 months|All participants||months||95% Confidence Interval|Median
116975|NCT00673738|Primary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the interval between the date of the first cetuximab administration and the date of objective progression of disease. Progression was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 36 months|All participants||months||95% Confidence Interval|Median
116976|NCT00673712|Secondary|Hospital Length of Stay|time (days) from date of admission to discharge|primary admission|all randomized subjects||days||Standard Deviation|Mean
116977|NCT00673712|Secondary|Surgical Site Infection|surgical site infection diagnosed within 30 days post surgery|30 days postoperative|all randomized subjects||participants|||Number
116978|NCT00673712|Primary|Hospital Acquired Pneumonia|Pneumonia diagnosed during hospitalization|30 days postoperative|all randomized subjects||participants|||Number
116979|NCT00673673|Secondary|Overall Survival||Upon completion of study, up to 3 years|||months||95% Confidence Interval|Median
116980|NCT00673673|Secondary|Overall Tumor Response Rate by RECIST Criteria|"Per response evaulation criteria in solid tumors criteria (RECIST) for target lesions assessed by FDG-PET Scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Upon completion of study|||percentage of participants|||Number
116981|NCT00673673|Primary|Progression Free Survival||Upon completion of study, up to 3 years|||months||95% Confidence Interval|Median
116982|NCT00673660|Secondary|Number of Participants With Reasons of Non-compliance to Statin Treatment|Participants were called for a final visit and reasons for non-compliance were recorded.|Month 12|Primary analysis population, subset of evaluable participants||participants|||Number
116983|NCT00673660|Secondary|Number of Participants With Reasons of Compliance to Statin Treatment|Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.|Month 12|Primary analysis population. The number of participants with reasons of compliance to statin treatment were not collected or analyzed.||participants|||Number
116984|NCT00673660|Secondary|Available Lipid Profiles of Compliant and Non-compliant Participants|Available laboratory measurements of participants were recorded in CRFs.|Month 12|Primary analysis population, subset of evaluable participants.||milligrams per deciliter||Standard Deviation|Mean
116985|NCT00673660|Primary|Percentage of Participants Who Were Compliant With Statin Treatment|The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.|Month 12|Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed.||Percentage of participants|||Number
116986|NCT00673595|Secondary|24-hour Ambulatory Blood Pressure|Ambulatory blood pressure will be measured using the Spacelabs 90202 recorder. Systolic and diastolic blood pressure during the 24-hour period will be analyzed.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.||mm Hg||Standard Deviation|Mean
116987|NCT00673595|Primary|Arterial Endothelial Function as Measured by Flow-mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area. This blood flow will be induced by inflation of a blood pressure cuff placed around the forearm to a pressure of at least 50 mm Hg above systolic pressure for 5 min, followed by release. The ultrasound image of the artery will be recorded continuously from 30 sec before until 2 min after cuff release.|2 weeks after participants quit smoking (study visit 3, day 15)|This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.||mm||Standard Deviation|Mean
116988|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Tmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.|||||
116989|NCT00673465|Secondary|Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).|||||
116990|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Cmax (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.|||||
116991|NCT00673465|Secondary|Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of T2DM participants after four weeks of treatment with SCH 497079 vs. placebo).|||||
116992|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No participants were randomized to treatment during Part 2 of the study.|||||
116993|NCT00673465|Secondary|Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States)|Blood samples for SCH 497079 pharmacokinetics will be collected at pre-dose/0-hour on Day 1 (Period 1 only) and pre-dose Day 14 and pre-dose/0-hour and at 0.5, 1, 2, 6, 12, and 24 hours post study drug administration (not breakfast) on Day 28 of the placebo and SCH 497079 periods only. In addition to these time points, a sample for metformin level will also be collected pre-dose on Day 1, Day 14, and Day 28 of the metformin administration period only.|Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug|No efficacy summary or analysis was completed for this outcome measure since the Part 1 objective was not met (i.e., to determine the 24-hour glycemic profile of type 2 diabetes mellitus [T2DM] participants after four weeks of treatment with SCH 497079 vs. placebo).|||||
116994|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|No participants were randomized to treatment during Part 2 of the study.|||||
123905|NCT00608491|Secondary|Change in Blood Hemoglobin Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||g/dL||Standard Deviation|Mean
116995|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States)|The post absorptive state is defined as the remaining part of day and night that is not the postprandial period. The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Baseline and Week 4|All participants who completed study treatment with at least SCH 497079 and placebo.||mg/dL||Standard Error|Least Squares Mean
116996|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.|||||
116997|NCT00673465|Secondary|Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|The postprandial period is defined as the sum of 4 hours after breakfast, 4 hours after lunch and 4 hours after dinner for a total of 12 hours. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.||mg/dL||Standard Error|Least Squares Mean
116998|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|No participants were randomized to treatment during Part 2 of the study.|||||
116999|NCT00673465|Secondary|Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 14 days after last dose of study drug (up to 98 days)|All randomized participants.||Participants|||Number
117000|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|No participants were randomized to treatment during Part 2 of the study.|||||
117001|NCT00673465|Primary|Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)|Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.|Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28|All participants who completed study treatment with at least SCH 497079 and placebo.||mg/dL||Standard Error|Least Squares Mean
117002|NCT00673452|Secondary|Change From Baseline in Weight at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.||kilograms (kg)||Standard Error|Least Squares Mean
117003|NCT00673452|Secondary|Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)|"C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline through 12 Weeks|Number of randomized patients.||participants|||Number
117004|NCT00673452|Secondary|Change From Baseline in Heart Rate at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.||beats per minute (bpm)||Standard Error|Least Squares Mean
117005|NCT00673452|Secondary|Change From Baseline in Blood Pressure at 12 Week Endpoint||Baseline, 12 weeks|Number of patients with a baseline and at least one post-baseline result.||mm Hg||Standard Error|Least Squares Mean
117006|NCT00673452|Secondary|Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint|Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 weeks|Number of randomized patients with baseline and at least one post-baseline data.||participants|||Number
117007|NCT00673452|Secondary|Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint|Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).|12 Weeks|Number of randomized patients with baseline and at least one post-baseline data.||participants|||Number
117008|NCT00673452|Secondary|Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint|Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
117009|NCT00673452|Secondary|Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint|"The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = greater than normal to 6 = totally absent. Total score ranges from 7 to 42."|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
117010|NCT00673452|Secondary|Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks|The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
117011|NCT00673452|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
117012|NCT00673452|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint|The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
117013|NCT00673452|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint|BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
117014|NCT00673452|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint|MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record.||units on a scale||Standard Error|Least Squares Mean
117015|NCT00673452|Secondary|Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint|BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, 12 weeks|Number of patients with a non-missing baseline and at least one post-baseline record. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
117016|NCT00673452|Primary|Patient's Global Impressions of Improvement (PGI-I) at Week 12|The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “very much improved,” a score of 4 indicates that the patient has experienced “no change,” and a score of 7 indicates that the patient is “very much worse.”|12 weeks|Number of randomized patients with baseline PGI-S and at least one post-baseline PGI-I data.||units on a scale||Standard Error|Least Squares Mean
117017|NCT00673439|Secondary|the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux||4 weeks after INR reaches 2 or more||||||
117018|NCT00673439|Primary|the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux|Study terminated, results data not available|at fondaparinux discontinuation||||||
117747|NCT00666757|Secondary|Change From Baseline in Weight at Week-12 Endpoint|Mean change from baseline to endpoint in weight|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=370; and Week 12: Duloxetine N=273, SSRI N=284||kilograms (kg)||Standard Error|Least Squares Mean
117019|NCT00673400|Other Pre-specified|SF36 Component Summary Scores|"Quality of life short form 36 version 2(SF36v2) standard form~PCS: physical component summary score (range 1 to 81, with 81 being the best) MCS: mental component summary score (range -9 to 82, with 82 being the best)~A score of 50 correlates with the result of a healthy standard US population (score transformation to a mean of 50 and a standard deviation of 10)~Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000."|Before surgery - 6 months|||units on a scale||Inter-Quartile Range|Median
117020|NCT00673400|Other Pre-specified|Obstructive Defecation Syndrome Score|"Score based on severity or frequency of 9 symptoms of obstructive defecation (physician administered)~(0 - 40, no symptoms = 0)~Dis Colon Rectum 51:348(DOI: 10.1007/s10350-007-9115-1)"|before surgery - 6 weeks -3 months - 6 months|||units on a scale||Inter-Quartile Range|Median
117021|NCT00673400|Other Pre-specified|Severity of Symptoms Score|"Score based on the severity of 9 symptoms of bowel movement (physician administered)~(0 - 36, no symptoms = 0)~Dis Colon Rectum 39:681 (DOI: 10.1007/BF02056950)"|before surgery - 6 weeks - 3 months - 6 months|||units on a scale||Inter-Quartile Range|Median
117022|NCT00673400|Secondary|Hospitalization|Length of hospital stay (Date of release - Date of admission + 1)|1 day to 1 year (until release from hospital)|||days||Full Range|Median
117023|NCT00673400|Secondary|Morbidity|Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)|1 year|||participants|||Number
117024|NCT00673400|Primary|Quality of Life|"Quality of life is measured by Fecal incontinence quality of life (FIQL)~Possible range of score 0 - 4 (Depression/Self perception 4.4)~0 = worst condition~Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)"|6 months after intervention|Participating in the FIQL survey was voluntarily. Some patients did not participate at all, some did not answer all questions. Patients answering >=50% of questions of a domain were counted as participants||units on a scale||Inter-Quartile Range|Median
117025|NCT00673387|Secondary|Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening (visit 2), Day 1, Weeks 1, 12, 28 (study termination). Heart Rate was measured in beats per min (bpm).|Screening to Week 28 (or early termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.||bpm||Standard Deviation|Mean
117026|NCT00673387|Secondary|Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained at Screening, Day 1, Weeks 1, 12, 28 (study termination). The PR interval, which is time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval (time from the beginning to the end of the QRS complex); QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 28 (or study termination)|Intent to treat population included all randomized participants who received at least one injection of study medication.||msec||Standard Deviation|Mean
117027|NCT00673387|Secondary|Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||participants|||Number
117028|NCT00673387|Secondary|Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28.|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||bpm||Standard Deviation|Mean
117029|NCT00673387|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg). Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28|Baseline to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||mm Hg||Standard Deviation|Mean
117030|NCT00673387|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Obtained at: Screening, Days -7, 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of laboratory values are cumulative across the study. Criteria for values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma/serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||Number of Laboratory Values|||Number
117094|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|Pharmacokinetic (PK) population consists of all subjects in the safety population (subjects who had taken one dose of study medication and had one follow-up safety assessment completed) who had evaluable concentration-time profiles.||ng/ml||Standard Deviation|Mean
117031|NCT00673387|Secondary|Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Values obtained at Screening, Day -7, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28. Numbers of values are cumulative across the study.|Screening to Week 28|Intent to treat population included all randomized participants who received at least one injection of study medication.||Number of Laboratory Values|||Number
117032|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Error|Mean
117033|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population|The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire which assesses sleep quality and sleep disturbances over a period of 1 month. The PSQI provides ratings on seven domains of sleep (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). The sum of the individual domains yields a global sleep quality score with a range of 0-21. A PSQI score >5 is indicative of poor sleep, which is characterized by severe difficulties in at least two domains, or moderate difficulties in three or more domains. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
117034|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population|The POMS is a mood scale consisting of 65 mood adjectives that assess participants’ mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each of the six POMS factors. The mood adjectives load onto 6 mood factors, which are as follows: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. The factor scores are added to obtain the total mood disturbance score. A lower total mood disturbance score indicates improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Error|Mean
117035|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The higher the score, the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Error|Mean
117036|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale (ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores indicate improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
117037|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants’ perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. The minimum and maximum score for the BES instrument is 0 and 55, respectively. The higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
117088|NCT00673049|Primary|Overall Survival|The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.|Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.||months||95% Confidence Interval|Median
117038|NCT00673387|Secondary|Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population|Subjective effects of weight loss were measured using the IWQOL-Lite questionnaire, a 31-item patient reported outcome (PRO) instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items have a range of 1 to 5 with 5=always true and 1= never true. The total score for the IWQOL-Lite instrument is measured on a scale from 0 (worst) to 100 (best). Higher scores indicate improvement. Values were obtained for this questionnaire on Visit 3 in the screening period.|Screening to Week 24|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Missing item responses may be imputed for each subject as appropriate before summarization.||units on a scale||Standard Deviation|Mean
117039|NCT00673387|Secondary|Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. Parameter was measured micro international units per milliliter. (µIU/mL).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding.||µIU/mL||Standard Error|Least Squares Mean
117040|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population|Baseline refers to Visit 5 (Day 1). If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Fasting samples were obtained at baseline, Weeks 4, 12, and 28. All parameters were measured in milligrams per deciliter (mg/dL).|Baseline to Week 28|Evaluable population: received at least one dose of randomized treatment, had adequate exposure to treatment, complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) presented above for TC, LDL and HDL cholesterol. Glucose n= 43, 50, 41, 46, 45, 43,44,36; Triglycerides n= 44,50,41,46,45,44,44.38.||mg/dL||Standard Error|Least Squares Mean
117041|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray Absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Fat-free mass were measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.||kg||Standard Error|Least Squares Mean
117042|NCT00673387|Secondary|LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan. Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Body fat mass was measured in kilogram (k).|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.||kg||Standard Error|Least Squares Mean
117043|NCT00673387|Secondary|Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population|Parameters of body composition were measured with a Dual Energy X-ray absorptiometry (DEXA) scan and reported as a percent (%). Data from the first valid DEXA scan obtained no later than 7 days after the first randomized dose was considered as valid baseline values; data from the last valid DEXA scan obtained no later than 10 days after last clinical visit or no later than 14 days after last dose of randomized study medication was considered as valid study termination values. Absolute change from baseline was defined as percent body fat at Week 28 - percent body fat at baseline.|Baseline to Week 28|Evaluable population includes participants received at least one dose of randomized treatment, had adequate exposure to treatment, and complied with the protocol as assessed prior to database lock and unblinding. Number analyzed (n) were of evaluable participants with valid DEXA scan at Week 28.||percentage of body fat||Standard Error|Least Squares Mean
117044|NCT00673387|Secondary|Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of Cmax was over a period of 2 hours following pramlintide administration at Weeks 4 and 24. Cmax was measured as picograms/milliliter (pg/mL).|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4 n=46,40,41,40,40,33 in each arm, respectively; Week 24 n=48,38, 44,40,35,36 in each arm, respectively.||pg/mL||Standard Error|Geometric Mean
117045|NCT00673387|Secondary|Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. Area under the concentration curve (AUC) time 0 to infinity (-inf). For AUC calculations, concentration at -5 min will be considered as 0 h concentration if quantifiable. AUC measured in picograms*hour/milliliter (pg*h/mL).|Weeks 4 and 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4: n=39,36,37,36,35,31 in each arm, respectively; Week 24 n=46, 35, 42, 39, 33, 35 in each arm, respectively.||pg*h/mL||Standard Error|Geometric Mean
117089|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||ng.h/ml||Standard Deviation|Mean
117046|NCT00673387|Secondary|Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide|Assessment of AUC was over a period of 2 hours following pramlintide administration. AUC (0 to time of last quantifiable concentration (-tlast). For AUC calculation, concentration at -5 min will be considered as 0 h concentration if quantifiable, otherwise, t=0 h. AUC measured as picograms*hour/milliliter (pg*h/mL). Pramlintide concentrations measured using a colorimetric immunoenzymetric assay employing monoclonal antibodies against pramlintide for both capture and detection.|Week 4 and Week 24|Evaluable population: participants received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Number (n) analyzed at Week 4:n=46, 40,41, 40,40,33 in each arm respectively;Week 24:n=48, 38, 44, 40, 35, 36.||pg*h/mL||Standard Error|Geometric Mean
117047|NCT00673387|Secondary|LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population|Waist circumference was measured at baseline (Day 1), Weeks 12, 28 (or at early termination) in centimeters (cm).|Baseline to Weeks 12 and Week 28|Participants who received at least 1 dose of randomized treatment and who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock/unblinding. Numbers (n) analyzed Week 12 n=45,51,41,47,45,45,45,38 in each treatment group respectively; Week 28 n= 44, 51, 41, 46, 45, 44, 43, 38 in each group, respectively.||cm||Standard Error|Least Squares Mean
117048|NCT00673387|Secondary|LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population|Least Squares (LS) mean absolute change in Body weight was measured in kilograms (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.||kg||95% Confidence Interval|Least Squares Mean
117049|NCT00673387|Secondary|Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used. Evaluable population: all participants who received at least one dose of randomized treatment, had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding. Leptin concentrations measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc.|Baseline to Week 28|Number analyzed (n) at baseline above. Week 4: n=41 45,46, 45, 45, 38; Week 8: n=41,45,46,44,45,37; Week 12: n=41, 46, 46, 45,45,38; Week 16: n=41,47,46,45,45,38; Week 20: n=41, 45,45,45,45,38; Week 24: n=40, 43, 46, 42, 44,38; Week 28: n=41, 45, 45, 44, 43, 36. Leptin concentration for placebo and pramlintide plus placebo groups not presented.||ng/mL||Standard Deviation|Mean
117050|NCT00673387|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population|Baseline refers to Day 1. If Day 1 value is missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 is used.|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.||participants|||Number
117051|NCT00673387|Primary|Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population|Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups).|Baseline to Week 28|Evaluable population includes all intent to treat participants (received at least one dose of randomized treatment) who had adequate exposure to treatment and complied with the protocol as assessed prior to database lock and unblinding.||Percentage change in kg||95% Confidence Interval|Least Squares Mean
117052|NCT00673361|Secondary|Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria||post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years||||||
117053|NCT00673361|Primary|Progression Free Survival (PFS)|Terminated study before accrual goal, no data analysis|3 weeks, 6 weeks, 16 weeks, & 24 weeks||||||
117054|NCT00673257|Primary|Population Estimates for Daunorubicinol Volume of Distribution|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean volume of distribution will be assessed.|prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 participant with insufficient specimen. 4 other participants were not analyzed as all samples time points were required for analysis and were not available.||Liter||Standard Deviation|Mean
117090|NCT00672984|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||ng.h/ml||Standard Deviation|Mean
117091|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||hours||Standard Deviation|Mean
117092|NCT00672984|Secondary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||hours||Standard Deviation|Mean
117055|NCT00673257|Primary|Population Estimates for Daunorubicinol Clearance|Pharmacokinetic parameters of Daunorubicin hydrochloride will be analyzed, samples were drawn according to the following schedule: prior to the drug infusion, at the midpoint of the infusion if infusion is ≥ 30 min in duration, end of infusion and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 (when feasible) hours after the end of the infusion. Samples will also be collected at 24, 48, and 72 (when feasible) hours after the end of the infusion. The concentration time data will be analyzed by model dependent and model-independent means. Pharmacokinetic data will be analyzed using ADAPT II software (Biomedical Simulations Resource, University of Southern California). Mean Daunorubicin hydrochloride Clearance will be assessed.|prior to drug infusion, midpoint, and end of infusion. Also 0.5,1,1.5,2,3,4,6,8 and 12 hours after end of infusion.|There were 107 patients enrolled, 4 participants withdrew consent and there was 1 patient with insufficient specimen. 4 other participants were not analyzed as all sample time points were required for analysis and were not available.||L/m2/hr||Standard Deviation|Mean
117056|NCT00673257|Secondary|Relationship Between Pharmacokinetics, Renal and Hepatic Function, and Complete Blood Count|Multivariate analysis of the data will also be performed. Assess the significance of the relationship between the following characteristics: BMI, BSA, ALT, bilirubin, age, gender, and ethnicity, and daunomycin PK parameters.|Length of study||||||
117057|NCT00673231|Other Pre-specified|Proportion of Participants With Lack of Glycemic Control|Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets|Baseline to Week 24|Full Analysis Set||Participants|||Number
117058|NCT00673231|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||mg/dL||95% Confidence Interval|Least Squares Mean
117059|NCT00673231|Secondary|Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction|To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
117060|NCT00673231|Secondary|Adjusted Mean Change in Calculated Mean Daily Insulin Dose|To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||IU/day||95% Confidence Interval|Least Squares Mean
117061|NCT00673231|Secondary|Adjusted Mean Change in Body Weight|To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
117062|NCT00673231|Primary|Adjusted Mean Change in HbA1c Levels|To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values||Percent||95% Confidence Interval|Least Squares Mean
117063|NCT00673179|Secondary|Quality of Life (Ped QL) Assessment||Peds QL measures at week 0 (during first chemo cycle), week 6, week 20, at end of therapy, and at 3 years.||||||
117064|NCT00673179|Primary|Treatment Success (6 or Fewer Hospitalizations During Front-line Chemotherapy)|Treatment success defined as a patient having 6 or fewer hospitalizations during front-line chemotherapy.|Baseline to 5 Years|Study terminated early without analysis.|||||
117065|NCT00673127|Secondary|Time to Progression|Duration of time from treatment initiation until documented progression (PSA or Disease progression)|Duration of time from treatment initiation until documented progression. Maximum 32 months|||months||95% Confidence Interval|Median
117066|NCT00673127|Primary|PSA Response|PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.|From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.|||percentage of participants||95% Confidence Interval|Number
117067|NCT00673114|Secondary|Number of Participants With Donor Cells at 100 Days Post-transplant||Post transplant|||participants|||Number
117068|NCT00673114|Secondary|Rates of Leukemic Relapse|Number of participants relapsed|Up to 2 years post transplant|||participants|||Number
117069|NCT00673114|Secondary|Number of Participants With Acute or Chronic Graft-versus-host Disease (GVHD)|Acute and chronic GVHD|two years|||participants|||Number
117070|NCT00673114|Secondary|Incidence of Primary and Secondary Graft Failure|Number of participants experiencing graft failure.|100 days post transplant|||participants|||Number
117071|NCT00673114|Secondary|Platelet Engraftment (Untransfused and Platelet Count > 50,000)|Participants platelet engrafted.|Approximately 1 year|||participants|||Number
117072|NCT00673114|Secondary|Non-Relapse Mortality at 180 Days Post Transplant||180 days|||participants|||Number
117073|NCT00673114|Secondary|180 Day Survival|Number of participants alive at 180 days post transplant|180 days|||participants|||Number
117074|NCT00673114|Primary|The Number of Participants Reaching Primary Endpoint of Absolute Neutrophil Count (ANC) of 500/uL (Engraftment).||By day 100|||participants|||Number
117075|NCT00673075|Secondary|Left Ventricular Ejection Fraction (LVEF) (%) at Week 18|Left ventricular ejection fraction (LVEF) (%) at Week 18|18 weeks post-treatment|||percentage||Standard Error|Mean
117076|NCT00673075|Secondary|Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18|18 weeks post-treatment|||participants|||Number
117077|NCT00673075|Secondary|Peripheral Systolic Blood Pressure (SBP)|Peripheral systolic blood pressure (SBP) at visit 13 (week 18)|18 weeks post initiation of randomized treatment|||mmHg||Standard Error|Mean
117079|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)|QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).|||||
117080|NCT00673049|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)|EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)|This outcome measure was added in Protocol Amendment 3 (28 January 2010). However, data were not collected as the majority of the subjects had already been enrolled prior to this amendment and the study was terminated shortly thereafter (02 March 2010).|||||
117081|NCT00673049|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.|||||
117082|NCT00673049|Secondary|Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)||Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)|Due to futility, the study was terminated early; therefore biomarker results were not analyzed.|||||
117083|NCT00673049|Secondary|Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group|"Analysis population included all participants treated with figi. Data are combined for figi+erlo and erlo then figi because the objective was to report any participants with positive ADA after exposure to figi regardless of figi administration order, rather comparison of these 2 treatment groups. N=number of participants evaluable."||percentage of participants|||Number
117084|NCT00673049|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.|||||
117085|NCT00673049|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group|Due to futility, the study was terminated early; therefore pharmacokinetic data were not analyzed.|||||
117086|NCT00673049|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response (OR) based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR are defined as complete disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.||percentage of participants||95% Confidence Interval|Number
117087|NCT00673049|Secondary|Progression Free Survival (PFS)|Time from randomization to date of first documentation of progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, who had a baseline and at least 1 on-study disease assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions.|Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months|Full (intent-to-treat) analysis set, which included all participants randomized regardless of treatment received.||months||95% Confidence Interval|Median
117093|NCT00672984|Secondary|Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6||pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose|PK population||ng/ml||Standard Deviation|Mean
117095|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
117096|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
117097|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 6||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||bpm||Standard Error|Least Squares Mean
117098|NCT00672984|Primary|Change From Baseline in Heart Rate (HR) at Tmax on Day 1||Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||bpm||Standard Error|Least Squares Mean
117099|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
117100|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
117101|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and Tmax (time of subject-specific maximum plasma concentration)|PD population||msec||Standard Error|Least Squares Mean
117102|NCT00672984|Primary|Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1|QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline, Tmax (time of subject-specific maximum plasma concentration)|"Pharmacodynamic (PD) population consists of all evaluable subjects with no major protocol deviations. Evaluable subjects were defined as subjects who received a Day 6 dose and had Day 6 data for the primary and secondary endpoints for all three periods."||msec||Standard Error|Least Squares Mean
117103|NCT00672958|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 6|Full analysis set.||participants|||Number
117104|NCT00672958|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where data were available; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
117105|NCT00672958|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36) at Week 6|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 6|Full analysis set where Baseline SF-36 data were available; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
117106|NCT00672958|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117138|NCT00672620|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set||participants|||Number
117107|NCT00672958|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117108|NCT00672958|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117109|NCT00672958|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A)|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least squares means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117110|NCT00672958|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least square means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117111|NCT00672958|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 5 and at least 50% decrease from Baseline at Week 6.|Baseline to Week 6|Full analysis set. Participants with missing values were classified as nonsustained responders/remitters.||percentage of participants|||Number
117112|NCT00672958|Secondary|Percentage of Participants in MADRS Remission at Week 6|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 6|Full analysis set; LOCF was used.||percentage of participants|||Number
117113|NCT00672958|Secondary|Percentage of Responders in HAM-D24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 5 and 6.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
117114|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 3, 4 and 5|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117115|NCT00672958|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 6|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 6|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
117116|NCT00672932|Primary|Change in CSF Concentrations of Neopterin After 12 Weeks|CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.||nmol/L||Standard Deviation|Mean
123906|NCT00608491|Secondary|Change in Blood Bicarbonate Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
117117|NCT00672932|Secondary|Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR|Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.|three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)|One subject in the raltegravir group was censored when a pharmacological study showed no drug in either plasma (n=9) or CSF. Six subjects randomized to no drug later rolled over to receive raltegravir. Primary analysis treated the rollover subjects as independent and compared 14 intensified to 9 nonintensified subject experiences.||percentage of cells||Standard Deviation|Mean
117118|NCT00672854|Secondary|Hospital Mortality||2-year||||||
117119|NCT00672854|Secondary|Insulin Sensitivity||2-year||||||
117120|NCT00672854|Secondary|Autonomic Nervous System||2-year||||||
117121|NCT00672854|Secondary|Oxidative Stress||2-year||||||
117122|NCT00672854|Secondary|Inflammatory Markers||2-year||||||
117123|NCT00672854|Secondary|Endothelial Function||2-year||||||
117124|NCT00672854|Primary|Rate of Nosocomial Infection Rate|Culture-proven infection including: wound, drain, respiratory tract, bloodstream infection (BSI), and urinary tract infections while receiving PN and during current hospitalization after study entry|Up to 28 days post-randomization|||participants|||Number
117125|NCT00672841|Primary|Safety and Tolerability of Preemptive Anidulafungin|reported as the Number of Adverse Events Possibly Related to Study Drug|weekly until ICU discharge|Subjects receiving at least 1 dose of anidulafungin were assessed.||events|||Number
117126|NCT00672841|Secondary|Incidence of Proven or Probable Invasive Fungal Infection (IFI)|Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis. Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria. However, BDG results were not factored into the EORTC/MSG criteria.|Participants were followed until ICU discharge, an average of 17 days|4 subjects in the preemptive therapy were excluded from this analysis. These subjects were treated with empiric antifungal therapy despite repeatedly negative glucan results.||participants|||Number
117127|NCT00672841|Secondary|Validate Gene Expression Signatures Predictive of IC||Study Completion, an average of 17 days|Data was not collected for this outcome measure.|||||
117128|NCT00672841|Primary|Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.|Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.|Participants were followed until ICU discharge, an average of 17 days|Two study subjects in the preemptive therapy arm were excluded from the analysis of assay sensitivity and specific due to icteric serum specimens.||participants|||Number
117129|NCT00672646|Secondary|VAS Pain on Jaw Movement at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.||Units on a VAS scale||Full Range|Median
117130|NCT00672646|Secondary|VAS Pain Intensity at Rescue Intake|0 = 'No pain' 100 ='Worst pain imaginable'|at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product|Only participants that took rescue medication are included in this analysis.||units on a VAS scale||Full Range|Median
117131|NCT00672646|Secondary|Time to First Meaningful Pain Relief|First meaningful pain relief is the time when the participant’s pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours|||hour||Inter-Quartile Range|Median
117132|NCT00672646|Secondary|Time to First Perceptible Pain Relief|First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours.|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours|||hour||Inter-Quartile Range|Median
117133|NCT00672646|Secondary|Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)|0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately.|Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.|||units on VAS scale||Full Range|Median
117134|NCT00672646|Primary|Sum of Pain Intensity Difference in Percent (SPID%)|Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).|from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours|||percentage of pain intensity change * h||Full Range|Median
117135|NCT00672633|Secondary|HDL Cholesterol|High Density Lipoprotein Cholesterol|3 months|Intention to Treat||mg/dL||Standard Error|Mean
117136|NCT00672633|Secondary|LDL Cholesterol|Low Density Lipoprotein Cholesterol|3 months|||mg/dL||Standard Error|Mean
117137|NCT00672633|Primary|Fasting Triglycerides|Fasting Triglycerides|3 months|Intention to Treat||mg/dL||Standard Error|Geometric Mean
117139|NCT00672620|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.||scores on a scale||Standard Error|Least Squares Mean
117140|NCT00672620|Secondary|Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117141|NCT00672620|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117142|NCT00672620|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)|The MADRS-S is a patient-reported outcome measure based on MADRS, administered to evaluate treatment effectiveness in depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 (best) and 3 (worst). The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment). LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8|"Full analysis set with available data at Baseline; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117143|NCT00672620|Secondary|Clinical Global Impression Scale-Global Improvement Scale|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment and center as fixed factors and the CGI-S Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117144|NCT00672620|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4, 6 and 8|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117145|NCT00672620|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.||percentage of participants|||Number
117146|NCT00672620|Secondary|Percentage of Participants With a Sustained Response in HAM-D24|A sustained response is defined as a ≥ 20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|Baseline to Week 8|Full analysis set with available data.||percentage of participants|||Number
117147|NCT00672620|Secondary|Percentage of Responders in HAM-D 24 Total Score by Study Visit|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||percentage of participants|||Number
117148|NCT00672620|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. LS means were from an ANCOVA model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Weeks 1, 2, 4, and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."||scores on a scale||Standard Error|Least Squares Mean
117149|NCT00672620|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug and had at least 1 valid postbaseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.||scores on a scale||Standard Error|Least Squares Mean
117150|NCT00672594|Primary|Change in Proliferation Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis||Percentage of Ki67 positive nuclei||Standard Deviation|Mean
117151|NCT00672594|Secondary|Interstitial Fluid Pressure (IFP)|Measure Interstitial fluid pressure (IFP) pre-treatment and during treatment to indirectly measure the effect of Sunitinib malate on transcapillary transport and correlate with other biologic evidence of treatment effect.Eligible patients who sign consent will undergo a baseline transrectal ultrasound (TRUS)-guided measurement of tumor IFP. Participants will then begin treatment with daily oral Sunitinib malate with biweekly monitoring for response and toxicity. After 4 weeks of therapy, patients undergo a repeat TRUS and tumor IFP measurement. Following a 1 to 2 week wash out period, patients undergo prostatectomy with pathologic tissue collection. This will be performed as a means to evaluate whether Sunitinib malate has the ability to decrease tumor IFP, and whether this correlates with other tr|4 years|This was an optional test and no patients chose to participate.|||||
117152|NCT00672594|Secondary|Difference in Gene Expression Patterns Using Microarray Analysis|Microarray data of 21 specimens from men enrolled who have undergone a prostatectomy and study treatment were compared to data from 21 prostatectomy only specimens. We used previously developed genomic signatures to measure the deregulation of oncogenic pathways built using Bayesian Probit models for ‘metagene’ factors from a singular value decomposition of top differentially expressed genes. A Monte Carlo Markov Chain was used to generate the predicted probabilities of pathway activity in normalized samples. We predicted the activity of these pathways, leading to the generation of probability measures that have previously reflected the state of pathway activity. These probability scores are interpreted as gene expression values to describe pathway activity patterns. A probability near 0 indicates a low chance of pathway activity; a probability near 1 indicates a higher likelihood of activity. Differences (treatment – control) in mean probability for each pathway are reported.|4 years|21 patients had adequate samples for analysis.||Probability||Standard Deviation|Mean
117153|NCT00672594|Secondary|Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.|We will perform immunohistochemistry staining on snap frozen specimens for endothelial and pericyte cell staining as previously described (42). Frozen prostate tumor biopsies are sectioned at 6μm thickness and fixed with acetone for 10 minutes. Endogenous peroxidase activity is quenched with 3% hydrogen peroxide for 15 min and then blocked with 5% normal serum. The slides are incubated with the primary antibody (1;100) overnight at 4 C°, and washed with PBS. Negative controls will be included by omission of the primary antibody. Biotinylated donkey antimouse antibody (1:1000, v/v) will be applied for 30 min at room temperature, followed by application of ABC kit (Vector Lab, Inc., Burlingame, USA). Slides are again washed in PBS and the color is developed by 5 min incubation with diaminobenzidine (DAB) solution. Slides are then counterstained with hematoxylin. Mean protein levels are presented.|4 years|Due to changes in the field, this test was not performed due to lack of relevance.|||||
117154|NCT00672594|Secondary|Change in Systemic Parameters Before and After Sunitinib Malate Treatment.|We evaluated candidate biomarkers of this pathway to predict for pharmacodynamic response to Sunitinib malate. In addition, a 7 ml plasma sample was collected at baseline and again at 4 weeks on all patients to assess possible biomarkers of response. Reported is the mean percent change in plasma concentration for each marker between 4 weeks and baseline.|Baseline and 4 weeks|17 patients had adequate measurements at both time points, were on an adequate dose, and took treatment at the correct time points.||Percent change||Standard Deviation|Mean
117155|NCT00672594|Secondary|Change in Pathologic (Microvessel Density).|Pathologic changes will be described using immuno-histochemical techniques (assessment of microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the MVD analysis. Results are reported as the difference in pre and post MVD. Units for MVD are number of CD31 cells per high powered field.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis||CD31 cells/High Powered Field||Standard Deviation|Mean
117156|NCT00672594|Secondary|Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity|Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to version 4.0 for the purposes of ClinicalTrials.gov reporting.|4 years|||participants|||Number
117157|NCT00672594|Primary|Change in Apoptotic Indices Before and After Treatment|Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.|Baseline and 4 weeks|Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis||Percentage of TUNEL positive cells||Standard Deviation|Mean
117163|NCT00672555|Primary|Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure|At 1 year all patients were assessed. Patients with a recurrence of a pilonidal sinus were counted. The result is given as number of patients suffering from a recurrence.|1 year|"Per protocol:~All patients treated in the study period, who gave their informed consent and meet the inclusion criteria, as well did not have any reason for exclusion were enrolled prospectively"||participants|||Number
117164|NCT00672490|Secondary|Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)|"The PANSS Supplemental Aggression Risk subscale score is the sum of 3 standard PANSS items – Excitement, Hostility and Depression – and 3 supplemental PANSS items related to anger – Anger, Difficulty in Delaying Gratification and Affective Lability and ranges from 6 to 42, where 6 is the best and 42 the worst score for the combined scale."|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
117165|NCT00672490|Secondary|Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42.|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
117166|NCT00672490|Secondary|Remission Rate (Number of Patients With Clinically Significant Remission)|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) at Day 28 was calculated.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. Total score ≤12 indicates remission."|From Baseline to 4 weeks|||Participants|||Number
117167|NCT00672490|Secondary|Response Rate (Number of Patients With Clinically Response)|The number of patients with clinically response (defined as ≥50% reduction in the YMRS total score from baseline to Day 28) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|From Baseline to 4 weeks|||Participants|||Number
117168|NCT00672490|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
117169|NCT00672490|Secondary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60.|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
117170|NCT00672490|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210|Baseline and 4 weeks|||units on a scale||Standard Deviation|Mean
117171|NCT00672490|Secondary|Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)|The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity|Baseline and 4 weeks|||score on a scale||Standard Deviation|Mean
117172|NCT00672490|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Baseline and 4 weeks|Per Protocol Population||score on a scale||Standard Deviation|Mean
117173|NCT00672438|Secondary|Sedation by Patient Report|"Sedation was assessed by measuring cognitive speed and by asking participants to indicate on a 100-mm visual analog scale (VAS) how sedated they felt. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no sedation was experienced. The other extreme end of the scale represents 100, and 100 represents as much sedation as possible. Participants are asked to indicate what point on that continuum best represents their experience of sedation."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117174|NCT00672438|Secondary|Maximum Drug Disliking|"At the end of an infusion stage participants were asked, What was the maximum that you disliked the drug at any moment (VAS)? (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the most they disliked the drug experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117175|NCT00672438|Secondary|Maximum Drug Liking|"At the end of an infusion stage participants were asked, What was the maximum that you liked the drug at any moment (VAS)? (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117748|NCT00666757|Secondary|Change From Baseline in Pulse Rate at Week-12 Endpoint|Mean change from baseline to endpoint in pulse rate|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285||beats per minute (bpm)||Standard Error|Least Squares Mean
117176|NCT00672438|Secondary|Average Drug Liking|"At the end of an infusion stage participants were asked, How much did you like the drug on average (100-mm VAS, 0 _ “not at all,” 100 _ “as much as possible”)? The VAS scale is 100mm long where one extreme end of the scale represents 0, and 0 indicates the participant did not like the drug experience. The other extreme end of the scale represents 100, and 100 indicates that the participant liked the drug experience as much as possible. Participants are asked to indicate what point on that continuum best represents the their experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117177|NCT00672438|Secondary|Maximum Pruritis|"At the end of an infusion stage participants were asked to rate the maximum severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their maximun experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117178|NCT00672438|Secondary|Average Pruritis|"At the end of an infusion stage participants were asked to rate the average severity of pruritis on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no pruritis experienced. The other extreme end of the scale represents 100, and 100 represents as much pruritis as possible. Participants are asked to indicate what point on that continuum best represents their average experience of pruritis."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117179|NCT00672438|Secondary|Maximum Nausea|"At the end of an infusion stage participants were asked to rate the maximum severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words not at all and as much as possible. This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their maximum experience of nausea."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117180|NCT00672438|Secondary|Average Nausea|"At the end of an infusion stage participants were asked to rate the average severity of nausea on a 100-mm visual analog scale (VAS) anchored by the words “not at all” and “as much as possible.” This means that the scale is 100mm long where one extreme end of the scale represents 0, and 0 represents no nausea experienced. The other extreme end of the scale represents 100, and 100 represents as much nausea as possible. Participants are asked to indicate what point on that continuum best represents their average experience."|At the end of each infusion stage. 2 times total.|All participants were included for analysis.||numerical score||Inter-Quartile Range|Median
117181|NCT00672438|Secondary|Sedation|Sedative opioid effects were assessed with the trail-making test (TMT) (Angst et al., 2004; Oswald and Roth, 1987). The TMT is a paper-and pencil test consisting of 4 different matrices listing numbers 1–90 in a 9 × 10 format. Subsequent numbers are located in neighboring rows or columns. Matrices were allocated randomly. Subjects had to connect numbers 1–90 as quickly as possible and the time to completion was recorded.|The trail making test was performed at training prior to study procedures, at baseline, and during each of the infusions.|All participants were included for analysis.||Time in seconds||Inter-Quartile Range|Median
117182|NCT00672438|Primary|Transcutaneous Partial Pressure of Carbon Dioxide|Partial pressure of transcutaneous carbon dioxide (CO2) was measured with aid of a pO2/pCO2-electrode (Perimed Inc., North Royalton, OH) mounted to the anterior chest wall.|Measured continuously throughout the study session ~ 5 hours|All participants were included for analysis.||mmHg||Inter-Quartile Range|Median
117183|NCT00672438|Primary|Respiratory Rate|Breaths per minute counted by direct observation and additionally recorded / external electronic monitoring.|Measured throughout the study session ~ 5 hours|All participants were included for analysis.||Breaths per minute||Inter-Quartile Range|Median
117184|NCT00672438|Primary|Cold Pain Tolerance|"Time in seconds~Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1–2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to remove their hand from the water bath when it was no longer tolerable - reported as pain tolerance."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.||Seconds||Inter-Quartile Range|Median
117185|NCT00672438|Primary|Cold Pain Threshold|"Time in seconds~Sensitivity to cold-pressor pain was tested by asking subjects to immerse their hand up to the wrist in ice water (1–2 C) continuously re-circulated within a 12-L container with the palm of the hand in full contact with the bottom of the container.They were asked to indicate the onset of pain - reported as pain threshold."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.||Seconds||Inter-Quartile Range|Median
117186|NCT00672438|Primary|Heat Pain Threshold|"Degrees Centigrade~Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin at the volar forearm. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature."|Participants underwent the pain testing measures at training prior to study procedures, at baseline and during each of the infusions.|All participants were included for analysis.||degrees centigrade||Inter-Quartile Range|Median
117215|NCT00671970|Secondary|Radiographic Response|"The number of participants with complete or partial response as determined by the following criteria:~Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses.~Partial response (PR): Greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose."|Patients were followed for the duration of the study, with a median follow-up of 103 weeks for grade III participants and 141.8 weeks for grade IV participants|||participants|||Number
117187|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
117188|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Presupplementary Motor Area (Pre-SMA) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in pre-SMA to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
117189|NCT00672256|Primary|Signal Change in fMRI BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Abstinent Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following not smoking for 24 hours.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following 24 hrs smoking abstinence|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
117190|NCT00672256|Primary|Signal Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Signal Between Response Inhibition Trials and Control Trials in Right Inferior Frontal Cortex (rIFC) During Task on Satiated Day|"Percent signal change in fMRI BOLD response in rIFC to correctly inhibited targets (as compared to control trials) during a response inhibition task following smoking as usual.~Response inhibition trials are trials in the task in which the participant must inhibit a response (not press the button)when presented with a No-Go trial. Control trials are trials in the task in which the participant must press the button when presented with a Go trial."|12.5 minutes of fMRI scanning following smoking as usual|18 participants completed all aspects of the study. Two participants were excluded from analyses because they reported falling asleep in the scanner and one was excluded because of an incidental finding during the scan.||percentage of signal change||Standard Deviation|Mean
117191|NCT00672243|Secondary|Number of Participants Experiencing a ≥ Grade 3, Treatment-related, Non-hematologic Toxicity.|Number of participants experiencing a ≥ grade 3, treatment-related, non-hematologic toxicity.|2 years|Intent to treat (ITT)||participants|||Number
117192|NCT00672243|Secondary|Best Radiographic Response|Best radiographic response per modified Macdonald criteria. Complete response: disappearance of all enhancing tumor, no new lesions, and no steroids or only maintenance doses. Partial response: ≥ 50% reduction in the products of the perpendicular diameters of all enhancing lesions, no new lesions, & steroids must be at a stable/decreasing dose. Stable disease: does not qualify for complete or partial response or progression & is stable clinically. Progression: ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|2 years|Intent to treat (ITT)||participants|||Number
117193|NCT00672243|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat (ITT)||weeks||95% Confidence Interval|Median
117194|NCT00672243|Secondary|Median Progression Free Survival (PFS)|Time in weeks from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|2 years|Intent to treat (ITT)||weeks||95% Confidence Interval|Median
117195|NCT00672243|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|Intent to treat (ITT)||percentage of participants||95% Confidence Interval|Number
117196|NCT00672204|Secondary|The Proportion of Subjects Who Have Experienced Serious Adverse Events Likely or Definitely Related to the Islet Transplant Protocol||At 365 days following the 1st islet transplant||||||
117197|NCT00672204|Secondary|The Proportion of Subjects With an HbA1c <7.0% AND Free of Severe Hypoglycemic Events From Day 28 to Day 1095 Inclusive.||3 years post final islet transplant||||||
117198|NCT00672204|Secondary|The Proportion of Subjects With an HbA1c <7.0% AND Free of Severe Hypoglycemic Events From Day 28 to Day 365 Inclusive.||1 year post first islet transplant||||||
117199|NCT00672204|Secondary|Insulin Independence and Islet Graft Function by Monitoring Insulin Requirements, HbA1c, Mixed-meal Tolerance Test, β-score, Frequently-sampled IV Glucose Tolerance, Glucose Variability and Hypoglycemia Duration||75 days and 1 year following first and subsequent islet transplants||||||
117216|NCT00671970|Primary|6 Month Progression-free Survival|The proportion of patients alive and progression free at 6 months|6 months|||proportion of participants||95% Confidence Interval|Number
117200|NCT00672204|Primary|The Proportion of Insulin-independent Subjects With Full Islet Graft Function|"Islet transplant recipients will be considered insulin-independent with full islet graft function if they are able to titrate off insulin therapy for at least 1 week and all of the following criteria are met:~HbA1c < 7.0% or a ≥2.5% decrease from baseline;~fasting capillary glucose level should not exceed 140 mg/dL (7.8 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 7 times in a seven day period);~2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 21 times in a seven day period);~fasting serum glucose level ≤126 mg/dL (7.0 mmol/L); if the fasting serum glucose level is >126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements;~evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥0.5 ng/mL (0.16 nmol/L)."|1 year following the first islet transplant|Raptiva was removed from market after 3 subjects were transplanted||participants|||Number
117201|NCT00672178|Primary|Number of Participants With Overall Complete and Partial Response (CR+PR)||8 weeks||||||
117202|NCT00672100|Secondary|Functional Outcome - Simple Shoulder Test (SST)|At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
117203|NCT00672100|Secondary|"Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful"|"Participants were asked to rate the helpfulness of their infusion:~extremely harmful~harmful~neutral~not harmful, but not helpful~helpful~extremely helpful"|at 24 and 48 hours after discharge from the hospital|||percentage of participants|||Number
117204|NCT00672100|Primary|Change in Diaphragmatic Displacement From Baseline to Post-surgery|Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.|Baseline, Post anesthesia care unit (PACU) - within 8 hours|||percent change||95% Confidence Interval|Mean
117205|NCT00672100|Primary|Pain Measurements Via Numeric Pain Rating Scales (NRS)|Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)|Discharge, 24 h, 48h, 12 weeks|||units on a scale||95% Confidence Interval|Mean
117206|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - VEGFR-2|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC score is the product of the percentage of cancer cells positive for VEGFR-2 multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year|||IHC Expression Score||Full Range|Median
117207|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF)|Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC expression score is the product of the percentage of cancer cells positive for VEGF multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300.|1 year|||IHC Expression Score||Full Range|Median
117208|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Six tumors had an insufficient measurement for analysis.||participants|||Number
117209|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Four tumors had an insufficient measurement for analysis.||participants|||Number
117210|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis.||participants|||Number
117211|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - EGFR vIII|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit.||participants|||Number
117212|NCT00671970|Secondary|Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR)|Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers.|1 year|Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis||participants|||Number
117213|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: AUC|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Area under the Curve (ng/mL.h) (AUC) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib||ng/ml.h||Full Range|Median
117214|NCT00671970|Secondary|Pharmacokinetics of Erlotinib: Cmax|Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Maximum Concentration (ng/mL) (Cmax) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib|Day 1 and 42 of Dosing Erlotinib|22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib||ng/ml||Full Range|Median
117217|NCT00671931|Primary|Motor Evoked Potential Amplitude|The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.|baseline, 30 minutes|||participants|||Number
117813|NCT00666562|Secondary|Absolute Change for Baseline From EGCG in Serum Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
117218|NCT00671918|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
117219|NCT00671918|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/nonlymphatic) and pathology status (presence/absence of tumor cells) was confirmed.||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
117220|NCT00671879|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)|Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.|baseline and day +14|Intent to Treat(ITT) population||marked statements||Standard Error|Least Squares Mean
117221|NCT00671879|Primary|Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale|on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.|baseline to 14 days|intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo||mm||Standard Deviation|Least Squares Mean
117222|NCT00671853|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
117223|NCT00671853|Secondary|Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction.|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
117224|NCT00671853|Secondary|Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score|"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.~1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
117225|NCT00671853|Secondary|Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7.|Week 0 - Week 8|||Participants|||Number
117226|NCT00671853|Secondary|Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8|||participants|||Number
117227|NCT00671853|Primary|Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score|A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.|Week 0 - Week 8|||units on a scale||Standard Deviation|Mean
117228|NCT00671788|Secondary|Overall Survival||Every other cycle up to 5 years|Eligible and treated participants||months||95% Confidence Interval|Median
117229|NCT00671788|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants||months||95% Confidence Interval|Median
117230|NCT00671788|Secondary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||Every cycle during treatment||||||
117231|NCT00671788|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and treated participants||percentage of participants||90% Confidence Interval|Number
117814|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.||ng/mL||Standard Deviation|Mean
117232|NCT00671788|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|||percentage of participants||90% Confidence Interval|Number
117233|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Burning/Stinging|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
117234|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
117235|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
117236|NCT00671749|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|"Please Note: Tolerability Assessments were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF."|12 weeks|Safety Population (n=99)||participants|||Number
117237|NCT00671749|Secondary|Global Assessment of Improvement From Baseline||12 weeks|||participants|||Number
117238|NCT00671749|Secondary|Global Severity Assessment Success|Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear|6 and 12 weeks|||participants|||Number
117239|NCT00671749|Primary|Percent Change From Baseline in Total Lesion Counts||6 and 12 weeks|||Percent Change||Standard Deviation|Mean
117240|NCT00671671|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. Results are reported for Cohort B at Day 3. Due to limited sampling, time interval over which plasma concentrations were measured after final dose was too short relative to projected t1/2. Therefore, t1/2 estimates were not calculated on Day 10.||hours||Standard Deviation|Mean
117241|NCT00671671|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||hours||Full Range|Median
117242|NCT00671671|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the PK parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||ng/mL||Standard Deviation|Geometric Mean
117243|NCT00671671|Secondary|Plasma Concentration at The End of Dosing Interval (Ctau)|Ctau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|PP analysis set. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. The Ctau on Day 1 was not necessary for interpretation of the PK data and hence was not analyzed.||ng/mL||Standard Deviation|Geometric Mean
117244|NCT00671671|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) was evaluated at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are reported for Cohort B at Day 3. Due to differences in sampling schedules between Cohort A and B, AUC (0 - ∞) data was not considered meaningful and hence were not analyzed on Day 10 for Cohort A.||ng*hr/mL||Standard Deviation|Geometric Mean
117255|NCT00671554|Primary|Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.|Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.|From first vaccine to 18 months after the last injection|||participants|||Number
117245|NCT00671671|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast). AUClast was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12, 14 hrs postdose on Day 1 for Cohort A, B, pre-morning dose, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post-evening dose on Day 3 for Cohort B, predose,0.5, 1, 2, 4, 8, 12, 24, 48 hrs postdose on Day 10 for Cohort A|PP analysis set. 'N' (number of participants analyzed) = participants evaluable for this measure. 'n' = participants evaluable for this measure at specified time points for each arm, respectively. Given the sampling schedule on Day 1 and Day 10 for 450 mg dose in Cohort A, AUClast data was not considered meaningful and hence were not analyzed.||ng*hr/mL||Standard Deviation|Geometric Mean
117246|NCT00671671|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours. AUCtau was evaluated at first dose on Day 1 for Cohort A and B, and at last dose for Cohort A (Day 10) and Cohort B (Day 3).|Predose, 0.5, 1, 2, 6, 8, 12 hours (hrs) postdose on Day 1 for Cohort A and B, pre-evening dose, 0.5, 1, 2, 4, 6, 8, 12 hrs post-evening dose on Day 3 for Cohort B, predose, 0.5, 1, 2, 4, 8, 12 hrs postdose on Day 10 for Cohort A|Per Protocol (PP) analysis set included all participants who took PF-00866554 and had sufficient plasma concentration data to facilitate calculation of the pharmacokinetic (PK) parameters. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
117247|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.||log10 IU/mL||Standard Deviation|Mean
117248|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Nadir: Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Change from baseline in plasma Log10 HCV RNA at nadir signified the maximum change observed during the study.|Baseline, Nadir (lowest HCV RNA level), assessed up to Day 11 for Cohort A and Day 4 for Cohort B|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.||log10 IU/mL||Standard Deviation|Mean
117249|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as the average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|MAS: a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.||log10 IU/mL||Standard Deviation|Mean
117250|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 4 (Cohort B): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 4 for Cohort B).|Baseline, Day 4|FAS included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.||log10 IU/mL||Standard Deviation|Mean
117251|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Modified Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (LLOQ = 12 IU/mL). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Modified Analysis Set (MAS): a subset of FAS which included all participants who had received complete dosage in the corresponding treatment regimen.||log10 IU/mL||Standard Deviation|Mean
117252|NCT00671671|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 11 (Cohort A): Full Analysis Set|Plasma HCV RNA levels were quantified using the Abbott RealTime HCV assay (lower limit of quantification [LLOQ] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as an average of screening, Day 0 and Day 1 (0 hour) measurements. Change from baseline in plasma log10 HCV RNA was calculated for all participants after the last day of dosing (Day 11 for Cohort A).|Baseline, Day 11|Full Analysis Set (FAS) included all randomized participants who took at least 1 dose of study medication and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load.||log10 IU/mL||Standard Deviation|Mean
117253|NCT00671606|Primary|Sentinel Node Identification Rate|Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.|15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes|Analysis was per protocol; no analysis conducted due to low detection rate.|||Participants||
117254|NCT00671554|Secondary|Tumor Response Measured by RECIST Criteria and Progression-free Survival.|CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.|From first vaccine to 18 months after the last injection|||participants|||Number
117256|NCT00671528|Secondary|Number of Days Required to Achieve Total Remission|The speed of action, measured as the number of days required to achieve total remission of all signs and symptoms of the disease.|Up to 28 days|||Days|||Number
117257|NCT00671528|Primary|Percent Improvement of Individually Measured Signs of the Disease|"Percent improvement of individually measured signs of the disease (erythema, vesiculation, scaling, pruritis) in a given target area that was chosen by the investigator was assessed objectively & quantified on a scale of 0-5 (0-absent, 5-very intense). Overall assessment reflected the changes in the disease & was carried out by the investigator.~The following scale was used:~Cure- Complete remission~> 75% reduction: Marked improvement~50-75% reduction: Moderate improvement~25-50% reduction: Slight improvement~<25% reduction: Ineffectiveness~Worsening of signs & symptoms"|Days 1 (prior to start of treatment), 8, 15, 21, and 28.|Due to lack of participant recruitment and therefore study termination, no analyses were performed.|||||
117258|NCT00671515|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) From Baseline to Study Endpoint|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. Typically cutoff of HOMA-IR for identifying those with insulin resistance is 2.5.|Week 0-Week 12|||units on a scale||Standard Deviation|Mean
117259|NCT00671515|Primary|Change in Depression Symptom Severity From Baseline to Study Endpoint|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 12|||Units on a scale||Standard Deviation|Mean
117260|NCT00671502|Secondary|Adverse Event Assessment|the number of adverse events reported during the course of the study as reported by the participants|up to 21 days||||||
117261|NCT00671502|Secondary|Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)||up to 14 days||||||
117262|NCT00671502|Primary|Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)|the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit|up to 14 days|efficacy analyses based on ITT population. LOCF used to impute missing data. To detect a 14% difference between the carisoprodol and placebo treated subjects, 196 ITTsubjects per group (alpha level 0.025,power 80%).Assuming 15% dropout rate, 226 subjects per group were needed.A total of678 subjects were required to achieve 584 ITT subjects.||mm||95% Confidence Interval|Least Squares Mean
117263|NCT00671437|Secondary|Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck||30 days after end of study treatment (approximately 1 year after start of treatment)|||participants|||Number
117264|NCT00671437|Secondary|Determine the Overall Disease Control Rate by RECIST Criteria as Assessed by CT and Clinical Examination and to Determine the TTP and the OS With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)||07/2016||||
117265|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Overall Survival With Cetuximab Therapy||Every 8 weeks until death (approximately 5 years)||07/2016||||
117266|NCT00671437|Primary|SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab.|"Eight weeks of treatment is equal to one cycle of treatment.~FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response."|Baseline and after 8 weeks of treatment|||SUVmax||95% Confidence Interval|Mean
117267|NCT00671437|Secondary|Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy|Cetuximab was continued after cycle 1 in patients with disease control(PR/SD) by CT, even if the FDG-PET/CT showed PMD. Cetuximab was discontinued after cycle 1 in patients with progression by CT.|Every 8 weeks until disease progression (up to 1 year)|||days||95% Confidence Interval|Median
117268|NCT00671437|Secondary|Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination||Every 8 weeks until disease progression (up to 1 year)|||participants|||Number
117269|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|Agreement in treatment decision using CT and FDG-PET/CT. Agreement in treatment decision occurred when tumor response by CT and FDG-PET/CT resulted in the same decision in treatment (continue cetuximab due to disease control or stop cetuximab due to progression). Disagreement in treatment decision occurred when tumor response assessment by CT and FDG-PET/CT resulted in different treatment decisions.|After 8 weeks of treatment|||participants|||Number
117270|NCT00671437|Secondary|Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination|A generalization of McNemar’s test was used to test for concordance of response(partial, stable or progression) by CT and by FDG-PET/CT.|After 8 weeks of treatment|||participants|||Number
117271|NCT00671437|Secondary|Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan|Definitions of anatomic response by RECIST for CT scan included: complete response(CR)—disappearance of all target and non-target lesions and no new lesions; partial response(PR)—at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter, persistence of one or more non-target lesions, and no new lesions; stable disease (SD)—neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started, persistence of one or more non-target lesions, and no new lesions; progressive disease(PD)—at least a 20% increase in the sum of the longest diameter of target lesions recorded since the treatment started, appearance of one or more new lesions/unequivocal progression of existing non-target lesions.|After 8 weeks of treatment|||participants|||Number
117272|NCT00671437|Secondary|Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT|Definitions of metabolic response by FDG-PET/CT included: complete metabolic response(CMR)—complete resolution of all metabolically active target and non-target lesions, and no new lesions; partial metabolic response(PMR)—20% or greater decrease in SUV of target lesions with or without decrease in number/size of non-target lesions, and no new lesions; progressive metabolic disease(PMD)—one or more new lesions, 20% or greater increase in SUV of target lesions and/or unequivocal increase in FDG activity of non-target lesions; and stable metabolic disease(SMD)—not qualifying as CMR, PMR, or PMD.|After 8 weeks of treatment|||participants|||Number
117273|NCT00671437|Primary|Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT|FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were <1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.|Baseline and after 8 weeks of treatment|||percentage of change||Full Range|Mean
117274|NCT00671060|Primary|Successful Expulsion of Fetus and Placenta Within 48 Hours||48 hours|One woman assigned to the 200μg arm was determined to be ineligible after enrollment due to a gestational age less than 14 weeks. She was not included in the analysis. One woman in the 100mcg arm was withdrawn from the study due to preeclampsia. She was included in the analysis as a failed induction.||participants|||Number
117275|NCT00670982|Secondary|Progression-free Survival|Median progression free survival measured in months|3 years|Median time from registration to progression of disease||months||Full Range|Median
117276|NCT00670982|Secondary|Objective Response Rate|Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and assessed by computed tomography.Complete response (CR), disappearance of all target and non-target lesions; partial response (PR), >/=30% decrease in the sum of longest dimensions of target lesions; objective response rate = CR + PR.|1 year|Confirmed objective response rate||percentage of participants|||Number
117277|NCT00670982|Primary|Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.|Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab.|1 year|What percentage of patients were still on study and without progression at one year||percentage of participants||95% Confidence Interval|Number
117278|NCT00670956|Secondary|Survival at One-month Between Study and Control Groups.|Status of neonate survival 30 days after delivery|30 days after delivery (up to approximately 24 weeks post-enrollment)|||participants|||Number
117279|NCT00670956|Secondary|Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)||Baseline, Delivery (up to approximately 20 weeks post-enrollment)|Study was terminated without enrollment to control arm; therefore, no comparison was made|||||
117280|NCT00670956|Primary|Incidence of Hydrops Fetalis||Delivery, up to approximately 20 weeks post-enrollment|Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm||participants|||Number
117281|NCT00670930|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy||78 weeks|The safety population consisted of all patients in the intent to treat (ITT) population that received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
117282|NCT00670930|Secondary|Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.||micrometer(µm)||Standard Deviation|Mean
117283|NCT00670930|Secondary|Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.||cells/mm^2||Standard Deviation|Mean
117284|NCT00670930|Secondary|Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples|The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Patients with both baseline and end of treatment (at the end of week 78) data were only included for the analysis under each category.||cells/mm^2||Standard Deviation|Mean
117285|NCT00670930|Primary|Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)|The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders. Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Baseline, at end of week 78|Intent-to-treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Patients with both baseline and af end of week 78 data in each category have been reported.||cells/mm^2||Standard Deviation|Mean
117286|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Amygdala|"Mu-opioid binding potential in right amygdala measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and 4 months|||ratio||Standard Deviation|Mean
117287|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Amygdala|"Mu-opioid binding potential in left amygdala measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)"|Baseline and after 4 months|||ratio||Standard Deviation|Mean
117288|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Right Nucleus Accumbens|"Mu-opioid binding potential in right nucleus accumbens measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women were included, 2 controls were excluded because repeat baseline HOMA2-IR %S was <80%.||ratio||Standard Deviation|Mean
117289|NCT00670800|Primary|Mu-opioid Binding Potential Measured in Left Nucleus Accumbens|"Mu-opioid binding potential in left nucleus accumbens is measured before and after 4 months of Metformin treatment.~Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.~Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)~Control group was measured at baseline only."|Baseline and after 4 months|All 7 PCOS women completed the protocol and were included. 5 of 7 controls were included in this analysis. 2 controls were excluded from analysis because repeat baseline OGTT showed HOMA %S of <80%.||ratio||Standard Deviation|Mean
117290|NCT00670748|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|66 months and 10 days|||participants|||Number
117291|NCT00670748|Secondary|Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month post treatment|||participants|||Number
117292|NCT00670748|Primary|Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 3 years|||participants|||Number
117293|NCT00670709|Primary|Quantitative Electroencephalography Absolute Alpha Power.|Absolute power in the alpha frequency as measured by quantitative electroencephalography|baseline EEG|||microvolts squared||Standard Deviation|Mean
117294|NCT00670709|Primary|Quantitative Electroencephalography Absolute Delta Power.|Absolute power in the delta frequency as measured by quantitative electroencephalography|baseline- one time point|||microvolts squared||Standard Deviation|Mean
117295|NCT00670540|Secondary|Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)||at 3 years|||percentage of participants||95% Confidence Interval|Number
117296|NCT00670540|Secondary|Percentage of Participants Who Developed Cancer Onset||at 3 years|||percentage of participants||95% Confidence Interval|Number
117297|NCT00670540|Secondary|Percentage of Participants Who Died From Any Cause||at 3 years|||percentage of participants||95% Confidence Interval|Number
117298|NCT00670540|Secondary|Percentage of Participants Who Developed Cardiovascular Events||at 3 years|||percentage of participants||95% Confidence Interval|Number
117299|NCT00670540|Secondary|Percentage of Participants With Treatment Anticoagulant Prescribed||after inclusion|||percentage of participants||95% Confidence Interval|Number
117300|NCT00670540|Secondary|Percentage of Participants Who Developed Major Bleeding Events||at 3 years|||percentage of participants||95% Confidence Interval|Number
117301|NCT00670540|Primary|Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)|new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.|at 3 years|||percentage of participants||95% Confidence Interval|Number
117302|NCT00670462|Secondary|Waist-to-hip Ratio at 30 Months||30 months|||ratio||Standard Error|Mean
117303|NCT00670462|Secondary|Waist-to-hip Ratio at 18 Months||18 months|||ratio||Standard Error|Mean
117304|NCT00670462|Secondary|Waist-to-hip Ratio at 12 Months||12 months|||ratio||Standard Error|Mean
117305|NCT00670462|Secondary|Waist-to-hip Ratio at 6 Months||6 months|||ratio||Standard Error|Mean
117306|NCT00670462|Secondary|Change From Baseline in Energy Intake at 18 Months||18 months|||kcal/day||Standard Error|Mean
117320|NCT00670449|Secondary|Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to Months 12, 24, 36, 48, and end of study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. • The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Units on a scale||Standard Deviation|Mean
117321|NCT00670449|Secondary|Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment|Disability progression was measured by the EDSS score. A trained neurologist grades the multiple sclerosis (MS) disability of the patient on a scale of 0-5 (no to severe disability) in 8 Functional Systems (FS): Pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (or mental), and other. The EDSS score ranges from 0-10 (normal to dead) with higher scores indicating greater disability. A 3-month confirmed disability progression was defined as a 3-month sustained increase from baseline in the EDSS score, that is, every EDSS score obtained (scheduled or unscheduled) within 3-months after the first progression met the following progression criteria: One point (1) increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point (0.5) increase in patients with baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined exactly the same except that the sustained progression had to last 6 months.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Percentage of patients||95% Confidence Interval|Number
117322|NCT00670449|Secondary|Percentage of Patients Relapse-free at the End of the Study|Patients who did not experience any relapses confirmed by a neurologist during the study were regarded as relapse-free patients.|Baseline to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010).(approximately 22 months before study completion)||Percentage of patients||95% Confidence Interval|Number
117323|NCT00670449|Secondary|Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses|The ARR was defined as the total number of relapses for all patients in the treatment arm / total number of days in the study for all patients in the treatment arm for the specific period of time × 365.25. General definition of relapse: Appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (< 37.5°C) or infection. A relapse was to be confirmed by a neurologist trained on the Expanded Disability Status Scale (EDSS). A relapse must be accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on 2 different Functional Systems (FS) of the EDSS or 2 points on 1 of the FS (excluding Bowel/Bladder or Cerebral FS).|Months 0-6, 6-12, 12-24, 24-36, 36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Relapses per year|||Number
117324|NCT00670449|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of new or newly enlarged T2 weighted MRI lesions were counted and recorded. New lesions were identified by comparing each lesion with previous scans. Lesions expanding through several slices were counted as only 1 lesion.|Months 0-3, 3-6, 6-9, 9-12, 12-18, 18-24, 24-36,36-48, and 48 to the end of the study (up to 4 years)|Core full analysis set(FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. Study became open-label with all patients receiving FTY720 0.5 mg/day. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb-2010). (approximately 22 months before study completion)||Percentage of patients|||Number
117325|NCT00670449|Primary|Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions|To ensure consistency, MRI scans were evaluated centrally at the Institute of Neurotherapeutics in Kyoto, Japan. After checking the scans for completeness and quality, all scans were analyzed by blinded readers (experienced neurologists). The number of Gd-enhanced T1 weighted MRI lesions were counted and recorded. Lesions expanding through several slices were counted as only 1 lesion.|Months 6, 9, 12, 18, 24, 36, and 48|Core full analysis set (FAS): All patients who were randomized in the core study and received at least 1 dose of core study drug. The study became open-label with all patients receiving FTY720 0.5 mg/day (by 22-Feb- 2010). (approximately 22 months before study completion)||Percentage of patients|||Number
117326|NCT00670306|Primary|IPSS Change From Baseline|International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26|Baseline and Week 26|Intention to treat (ITT) analysis with Last Observation Carried Forward (LOCF) imputation technique||Units on a scale||Standard Deviation|Mean
117408|NCT00669396|Primary|Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception|Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.|6 months|||participants|||Number
117327|NCT00670267|Secondary|Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline|In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline to end of study (105 days)|||units on a scale||Standard Deviation|Mean
117328|NCT00670267|Secondary|Percent Change in FEV1% Predicted From Baseline to End of Study||Baseline to end of study (105 days)|||percent change in FEV1% predicted||Standard Deviation|Mean
117329|NCT00670267|Secondary|Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)|Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).|Baseline to end of study (105 days)|Analysis excludes one early termination subject||mg/mL||Standard Deviation|Mean
117330|NCT00670267|Primary|Daily Dose at Study Termination Across Participants|The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.|Baseline to end of study (105 days)|||participants|||Number
117331|NCT00670267|Primary|Mean Daily Dose at Study Termination Across Participants|The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.|Baseline to end of study (105 days)|||mg||Standard Deviation|Mean
117332|NCT00670241|Secondary|Subjects With Rebound During the Study||Week 8-16|||participants|||Number
117333|NCT00670241|Secondary|Subjects With Relapse During the Study|Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit|Week 8-16|||participants|||Number
117334|NCT00670241|Secondary|The Percentage Change in PASI From Baseline to Week 8|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).|Baseline, Week 4 and 8|||Percent change in PASI score|||Number
117335|NCT00670241|Secondary|"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity at Week 4"||Week 4|||participants|||Number
117336|NCT00670241|Primary|"Subjects With Controlled Disease (Clear or Almost Clear Disease) According to Investigator's Global Assessment of Disease Severity at Week 8"||Week 8|||Participants|||Number
117337|NCT00670228|Secondary|Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)||At Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.||mg/L||Standard Deviation|Mean
117338|NCT00670228|Secondary|Occurrence of the Major Adverse Cardiovascular Events (MACE)|"MACE:~Cardiac death, New onset or worsening congestive heart failure (>24 h post-admission) event evaluating using New York Heart Association (NYHA) Class II or greater Non-fatal Myocardial Infarction, Severe arrhythmia, Stroke/TIA (Transient Ischemic Attack), Cardiogenic shock, Catheterization/revascularization, Unstable angina leading to hospitalisation"|At Day 60|Analysis was performed on the safety population which includes all subjects who received any study treatment. All subjects in this population were analyzed according to the actual treatment they received.||events|||Number
117339|NCT00670228|Secondary|Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)|Due to study early termination and the limited number of randomized subjects, descriptive statistics for the Day 3 Ejection Fraction were selected for presentation instead of for Day 60 as initially planned.|At Day 3|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.||percentage of Ejection Fraction||Standard Deviation|Mean
117340|NCT00670228|Primary|Infarct Size Absolute Change From Baseline at Day 60|Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.|From baseline at Day 60|Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.||percentage of LV mass change||Standard Deviation|Mean
117341|NCT00670007|Secondary|Percentage of Subjects With Treatment Emergent Adverse Events|Percentage of subjects with treatment-emergent adverse events (TEAEs): overall, by severity, by relatedness, by seriousness, and which occurred within 24 hours of Zemaira administration.|From baseline up to 2.5 years|Safety population comprises all subjects who were included in the study and who received at least 1 dose of Zemaira during study CE1226_3001.||percentage of subjects|||Number
117342|NCT00670007|Secondary|Time to First Pulmonary Exacerbation||Up to 2 years|ITT population.||years||95% Confidence Interval|Median
117343|NCT00670007|Secondary|Annual Rate in Subject Years of Pulmonary Exacerbations|Annual exposure‑adjusted incidence rate of pulmonary exacerbations.|Up to 2 years|ITT population.||Exacerbations/subject year||95% Confidence Interval|Number
117344|NCT00670007|Secondary|Number of Subjects With Pulmonary Exacerbations||Up to 2 years|ITT population.||participants|||Number
117345|NCT00670007|Secondary|Percent Change in Lung Function as Measured by Percent Predicted FEV1||From baseline up to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
117815|NCT00666562|Secondary|Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA||Baseline and up to day 28|Analysis was not able to be completed for 2 participants in Arm I.||ng/mL||Standard Deviation|Mean
117348|NCT00670007|Secondary|Change in Subject-reported Symptoms|Patient-reported symptoms were measured using the St George's Respiratory Questionnaire (SGRQ). SGRQ total, symptoms, activity and impact scores range from 0 to 100, with higher scores indicating more limitations, and change from baseline below zero (0) is favorable, indicating improvement.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||units on a scale (change from baseline)||Standard Deviation|Mean
117349|NCT00670007|Secondary|Percent Change in Adjusted Lung Density|Percent change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average percent change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||Percent change from baseline||Standard Deviation|Mean
117350|NCT00670007|Secondary|Absolute Change in Adjusted Lung Density|Absolute change from baseline to 2 years as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average absolute change in the early start and delayed start subgroups from an analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect. The baseline is the last assessment from the preceding study CE1226_4001.|From baseline to 2 years|ITT population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||g/L||Standard Error|Least Squares Mean
117351|NCT00670007|Primary|Rate of Change of Adjusted Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (Total Lung Capacity; ie, full inspiration) and FRC (Functional Residual Capacity; ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in the early start and delayed start subgroups from a linear random regression model with country, inspiration state (only for 'TLC and FRC state'), time (time elapsed since Day 1 [CE1226_4001]), treatment and treatment by time interaction as fixed effects and subject and subject by time interaction as random coefficients.|Up to 2 years|Intention-to-treat (ITT) population. Subjects may not have been included in all efficacy analyses because of missing efficacy assessments.||g/L per year||Standard Error|Least Squares Mean
117352|NCT00669955|Secondary|Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level|Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)|Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only|Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints.||participants|||Number
117353|NCT00669955|Secondary|Overall Compliance to Study Medications|Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population|At the end of the treatment phase (days 8-14)|Safety population.||participants||Standard Deviation|Mean
117354|NCT00669955|Secondary|Metronidazole Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml|Measured at baseline|Per protocol population||participants|||Number
117355|NCT00669955|Secondary|Clarithromycin Resistance|Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above|Measured at baseline|Per protocol analysis population||participants|||Number
117356|NCT00669955|Secondary|H. Pylori Eradication and Presence or Past History of Peptic Ulcers|Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.|Week 6 and week 10 follow-up visits|Per protocol population.||Participants|||Number
117357|NCT00669955|Secondary|Number of Patients Experiencing Treatment Emergent Adverse Events.|"A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation.~All safety analysis based on the safety population."|at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.|Safety population, described as all randomized patients having received at least one dose of study medication||Participants|||Number
117358|NCT00669955|Primary|Helicobacter Pylori Eradication Confirmed by Urea Breath Test|H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.|Week 6 and week 10 follow-up visits|No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations.||Participants|||Number
117359|NCT00669942|Secondary|Disease Activity Score (DAS28) of Parts 2 and 3 Participants|The DAS28 is a composite score based on tender and swollen joint counts, C reactive protein (CRP) concentrations, and the participant's global disease activity based on a visual analogue scale (VAS). The tender joint count (based on 28 joints) was calculated by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. The information on various types of tenderness was then collapsed into a single tender versus non-tender dichotomy, and the number of joints that were classified as tender was recorded. The swollen joint count was calculated in the same manner. For CRP concentrations, blood samples were collected and sent to a central laboratory for assessment. For the VAS assessment, the participant used a 100 mm horizontal VAS to assess the severity of his or her arthritis where 0 = none and 100 = most severe. DAS28 scores range from <2.6 (disease remission) to >5.1 (high disease activity).|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.||scores on a scale||Standard Error|Mean
117360|NCT00669942|Secondary|Percentage of Parts 2 and 3 Participants Who Achieved ACR50 and ACR70|Clinical response to treatment was assessed according to ACR50 and ACR70 criteria. A participant was defined as an ACR50 or ACR70 responder if the following 3 conditions were met: 1) improvement of ≥50% or ≥ 70%, respectively, in the number of tender joints, 2) improvement of ≥50% or ≥ 70%, respectively, in the number of swollen joints and 3) improvement of ≥50% or ≥ 70%, respectively, in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.||Percentage of participants|||Number
117361|NCT00669942|Primary|Pharmacokinetics PK of AIN457: T1/2 in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||Day||Standard Deviation|Mean
117362|NCT00669942|Primary|Pharmacokinetics PK of AIN457: CL in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||Liters/day||Standard Deviation|Mean
117363|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Vz in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||Liter||Standard Deviation|Mean
117364|NCT00669942|Primary|Pharmacokinetics PK of AIN457: AUClast and AUCinf in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||day*ug/mL||Standard Deviation|Mean
117365|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Cmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||ug/mL||Standard Error|Mean
117366|NCT00669942|Primary|Pharmacokinetics PK of AIN457: Tmax in Parts 2 and 3 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||day||Full Range|Median
117367|NCT00669942|Primary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis.||day||Standard Deviation|Mean
117368|NCT00669942|Primary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||Liters/day||Standard Deviation|Mean
117369|NCT00669942|Primary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||Liters||Standard Deviation|Mean
117370|NCT00669942|Primary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||day*ug/mL||Standard Deviation|Mean
117371|NCT00669942|Primary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||ug/mL||Standard Deviation|Mean
117372|NCT00669942|Primary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 Participants|Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 29, 36, 43, 57, 71, 85, 99 and 113.|Day 113|Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile.||day||Full Range|Median
117373|NCT00669942|Primary|Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20)|Clinical response to treatment was assessed according to ACR20 criteria. A participant was defined as an ACR20 responder if the following 3 conditions were met: 1) ≥20% improvement in the number of tender joints, 2) ≥20% improvement in the number of swollen joint and 3) ≥20% improvement in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant.|Day 43|The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants.||percentage of participants|||Number
117374|NCT00669916|Secondary|Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants||day||Standard Deviation|Mean
117375|NCT00669916|Primary|Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score|The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement.|Baseline, Week 4|All participants||Percentage of participants|||Number
117376|NCT00669916|Secondary|Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||Liters/day||Standard Deviation|Mean
117377|NCT00669916|Secondary|Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||Liters||Standard Error|Mean
117378|NCT00669916|Secondary|Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|All AIN457A treatment group participants||day*ug/mL||Standard Deviation|Mean
117379|NCT00669916|Secondary|Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||ug/mL||Standard Deviation|Mean
117380|NCT00669916|Secondary|Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.|Day 182|The population included all AIN457 treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.||days||Full Range|Median
117381|NCT00669916|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement.|Baseline, Week 4|All participants||Percentage change in PASI mean score|||Number
117382|NCT00669903|Secondary|CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14|GMRT score defined as the –log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate|Baseline and Day 14|||unit on a scale||Standard Error|Least Squares Mean
117816|NCT00666562|Secondary|Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry||up to 28 days|||optical density||Standard Deviation|Mean
117383|NCT00669903|Secondary|CogState Identification Task (IT) Standardized Change Score at Day 14|IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate|Baseline and Day 14|||unit on a scale||Standard Error|Least Squares Mean
117384|NCT00669903|Secondary|CogState Detection Task (DT) Standardized Change Score at Day 14|DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
117385|NCT00669903|Secondary|CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14|OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
117386|NCT00669903|Secondary|CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14|GMLT score is defined as the –log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
117387|NCT00669903|Primary|CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14|The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).|Baseline and Day 14|||units on a scale||Standard Error|Least Squares Mean
117388|NCT00669864|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||episodes|||Number
117389|NCT00669864|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||episodes|||Number
117390|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage of participants|||Number
117391|NCT00669864|Secondary|Percentage of Subjects Achieving HbA1c Less Than 7.0%|Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage of participants|||Number
117392|NCT00669864|Secondary|Change in 8-point Plasma Glucose Profile|Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||mg/dL||Standard Error|Mean
117393|NCT00669864|Primary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.||percentage (%) of total haemoglobin||Standard Error|Mean
117394|NCT00669682|Primary|Number of Positive Twave Studies and Concurrent Positive Optivol Measurement|We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.|upto 3 years|||participants|||Number
117409|NCT00669331|Other Pre-specified|Cost Effectiveness of Treating Patients With Bronchiectasis With Inhaled Mannitol|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, cost effectiveness was not collected).|52 weeks|Not collected. As the primary objective of this study did not reach statistical significance, cost effectiveness data were not collected.|||||
123907|NCT00608491|Secondary|Change in Blood Urea Nitrogen/Urea||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
117395|NCT00669617|Primary|Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose|FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.|Five Minutes Post Dose|Modified Intent-to-Treat (mITT) population: including all randomized patients who received at least one dose of study drug. If any of the values used in the period baseline FEV1 and FEV1 at 5 min post-dose were collected within 6 hours of rescue medication, then the individual FEV1 value was set to missing.||Liters||Standard Error|Least Squares Mean
117396|NCT00669578|Primary|Best Overall Response Over the First 6 Cycles of Treatment|"Response evaluation:~Complete Remission (CR):~Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow.~Partial Hematologic Response/Partial Remission (PR):~Increase in neutrophil by 50% + above 10^9/L for neutropenia)~Clinical Improvement (CI):~Increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts."|Every cycle of treatment for 6 cycles. Each cycle is 28 days.|None of the participants from the Phase I cohort were analyzed for this endpoint. All 65 Phase II participants were evaluable for this endpoint and included in the analysis.||participants|||Number
117397|NCT00669578|Secondary|Time to Response|The time to response is defined as the time from study registration to the first date at which the patient’s objective status was classified as a response (CR, PR or CI). In patients who do not achieve a response, time to response will be censored at the patient’s last evaluation date. The distribution for each of these event-time variables (duration of response and time to response) will be estimated by Kaplan-Meier curves.|Time from registration to the first date of response within twelve 28-day cycles of treatment.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) patients were recruited for the Phase II portion. Only 9 of the 65 patients achieved a response. Thus, the median of time to response and the upper limit of 95% confidence interval are not attainable.|||||
117398|NCT00669578|Secondary|Duration of Response Time|Duration of response is defined as the date at which the patient’s objective status is first noted to be a CR, PR or CI to the date progression is documented (if one has occurred) or to the date of last follow-up(for those patients who have not progressed).|Time from response to disease progression, intolerance of study drug, or death.|None of the Phase I participants were evaluable for this endpoint. Sixty-five (65) participants were recruited for the Phase II portion. Results presented here are on the 9 Phase II patients who responded to treatment.||Months||95% Confidence Interval|Median
117399|NCT00669578|Secondary|Number of Participants With Treatment Related Adverse Events.|Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. The number of participants with grade 3 or higher adverse events at least possibly related to study treatment are reported here.|During treatment and every 6 months until 3 years from registration or progression.|None of the Phase I participants were used for this primary endpoint. All 65 Phase II participants were evaluable for this endpoint.||participants|||Number
117400|NCT00669578|Primary|Determine the Maximum Tolerated Dose of CC-4047|Starting at a dose level of 2.5 mg/d on days 1-21 in every 28 day cycle, participants were accrued in cohorts of three to assess dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD). Dose escalation at increments of 0.5 mg/d was done if no subject had a DLT (a grade 4 or higher hematologic toxicity or a grade 3 or higher febrile neutropenia or a grade 3 or higher non-hematologic toxicity) in cycle 1. Subsequent cohorts were treated until the maximum tolerated dose (MTD) was reached (dose level before that which results in a DLT in >1 of 6 subjects). Subsequent participants were treated at the MTD, those without response at the MTD after 3 cycles were lowered to the minimal efficacious dose (MED) of 0.5 mg daily. Here, we are reporting the percentage of participants in Phase I with a DLT at each dose level.|The first 28-day cycle of treatment.|None of the Phase II participants were evaluable for this endpoint. For the Phase I portion of this study, three participants were accrued at a 2.5 mg/day dose level, six at the 3.0 mg/day dose level, and three at the 3.5 mg/day dose level.||percentage of participants with DLT|||Number
117401|NCT00669552|Primary|Number of Subjects With Positive T Wave Studies During a Coronary Intervention|Positive T wave alternans is determined by a proprietary program using ECG recordings during a stress test. The result is reported as positive, negative, or indeterminate.|During the coronary intervention, upto 2 hours|Only collected on subjects that had an intervention||participants|||Number
117402|NCT00669539|Primary|Mean Amblyopic Eye Visual Acuity Improvement With Spectacles|Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated. A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.|Enrollment to 18 Weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.||logMAR units||Standard Deviation|Mean
117403|NCT00669461|Secondary|Average Number of Spontaneous Bowel Movements (SBM) Per Week|Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient.|||||
117404|NCT00669461|Primary|Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks|The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).|up to 6 weeks|Analysis was not performed for this outcome measure secondary to the small sample size ( one patient)|||||
117410|NCT00669331|Other Pre-specified|Health Related Quality of Life (HRQL) and Quality Adjusted Life Years (QALYs) by Treatment Group Using Utility Scores From the Health Utilities Index Questionnaire|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data and external information (Note as the primary objective of this study did not reach statistical significance, HRQL and QALYs were not collected).|52 weeks|No data were collected for this assessment. As the primary objective of this study did not reach statistical significance, HRQL and QALYs were not derived.|||||
117411|NCT00669331|Other Pre-specified|Health Status and Utility Scores|In the presence of a significant primary endpoint, these data were intended to be derived from the trial data and external information (Note as the primary objective of this study did not reach statistical significance, differences in health status and utility scores were not assessed)|52 weeks|No data were collected. As the primary objective of this study did not reach statistical significance, health status and utility scores were not derived.|||||
117412|NCT00669331|Other Pre-specified|Health Related Costs of Treating Patients With Bronchiectasis|In the presence of a significant primary endpoint, these data were intended to be derived using the trial data together with external information (Note as the primary objective of this study did not reach statistical significance, health related costs were not assessed)|52 weeks|No data were collected. Since the primary objective was not significant in this study, further exploration of health economic endpoints was not done.|||||
117413|NCT00669331|Secondary|• (Exploratory) Number of Hospitalizations Due to Pulmonary Exacerbations|Mean rate of hospitalisations (number/year) summarised and analysed to take account of differing follow-up times.|52 weeks|||hospitalisations/year||95% Confidence Interval|Mean
117414|NCT00669331|Secondary|Safety Profile - Hematology|hematology assessed as clinically significant abnormal FBC (Full Blood count) at any point post baseline.|52 weeks|||participants|||Number
117415|NCT00669331|Secondary|Safety Profile - Clinical Chemistry|Clinical chemistry was assessed as clinically significant abnormal liver function test and clinically significant abnormal urea/electrolyte test at any point post baseline.|52 weeks|||participants|||Number
117416|NCT00669331|Secondary|Safety Profile - Sputum Microbiology|sputum microbiology assessed as the presence of abnormal flora in sputum sample taken at any post baseline visit|52 weeks|||participants|||Number
117417|NCT00669331|Secondary|Lung Function - Change in FEF25-75 (Forced Expiratory Flow Rate Averaged Over 25th -75th Percentile of FVC)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||mL/s||95% Confidence Interval|Least Squares Mean
117418|NCT00669331|Secondary|Lung Function - Change in FEV1/FVC|FEV1 expressed as a ratio of FVC. Endpoint is expressed as a percentage ie FEV1/FVC*100|52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||ratio (expressed as a %)||95% Confidence Interval|Least Squares Mean
117419|NCT00669331|Secondary|Lung Function - Change in FVC (Forced Vital Capacity)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||mL||95% Confidence Interval|Least Squares Mean
117420|NCT00669331|Secondary|Lung Function - Change in FEV1 (Forced Expiratory Volume in One Second)||52 weeks|Randomised and treated with at least one post-baseline spirometry assessment||mL||95% Confidence Interval|Least Squares Mean
117421|NCT00669331|Secondary|Daytime Sleepiness Scores|Epworth Sleepiness Scale (ESS) score was calculated as the sum of scores for each of eight individual questions, such that a total score of zero represents no daytime sleepiness, and a total score of 24 represents the maximum degree of daytime sleepiness. Measured at baseline, 6 weeks, 16 weeks, 28 weeks, 40 weeks, 52 weeks|52 weeks|||units on a scale||Standard Deviation|Mean
117422|NCT00669331|Secondary|Sputum Volume|24 hour sputum weight, measured at baseline, week 6, week 16, week 28, week 40, week 52|52 weeks|||g||Standard Deviation|Mean
117423|NCT00669331|Secondary|Duration of Graded Exacerbations|Duration of graded exacerbations is defined as the number of days with graded PE within one treatment year. Mean days estimated via negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, with log of follow-up time as the offset variable|52 weeks|Randomised and treated||Days with GPE||95% Confidence Interval|Mean
117424|NCT00669331|Secondary|Time to First Graded Exacerbation|Time to first graded exacerbation is defined as the duration (in months) from the randomisation date to the start of the first reported graded PE during the on-treatment period. Patients without reported graded PE event will be censored at the last participation.|52 weeks|Randomised and treated||months||95% Confidence Interval|Median
117425|NCT00669331|Secondary|Antibiotic Use Prescribed for Treated Pulmonary Exacerbations|Rate of antibiotic treated graded pulmonary exacerbations, using the same definition of a graded pulmonary exacerbation as the primary endpoint. A graded pulmonary exacerbation was considered to be anti-biotic treated if use of oral, IV or inhaled antibiotic use was recorded related to the GPE event.|52 weeks|Randomised and treated (referred to as ITT)||events/year|||Number
117426|NCT00669331|Secondary|Quality of Life as Measured by the St. Georges Respiratory Questionnaire (SGRQ) Total Score|The SGRQ was collected at baseline, week 6, week 16, week 28, week 40 and week 52. Change in total score was calculated from baseline. Total scores are a weighted sum across all questions. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. Higher scores indicate lower quality of life. Outcome data table gives the raw mean total score at each visit.|52 weeks|Randomised and treated with one or more post-baseline SGRQ data available||units on a scale||Standard Deviation|Mean
117427|NCT00669331|Primary|Rate of Graded Pulmonary Exacerbations|A graded pulmonary exacerbation was defined as a worsening in signs and symptoms requiring a change in treatment (Center for Drug Evaluation and Research (CDER), 2007). Grade I was required 3 main signs and symptoms, Grade II 2 main signs and symptoms and Grade III 1 main and one or more minor signs and symptoms. Main signs and symptoms were increased cough, sputum volume or sputum purulence. Minor were upper respiratory tract infection, fever, increased wheezing, increased dyspnea, increase in respiratory rate, increase in cardiac frequency of >20%, and increased malaise, fatigue or lethargy. Rate is defined as the number of all GPE events observed in one treatment year|52 weeks|Randomised and Treated (referred to as the ITT population in this trial)||GPE events per year|||Number
117428|NCT00669318|Secondary|Time to Retreatment|Time to subsequent therapy is defined to be the time from the registration to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier|Follow-up status and retreatment information will be collected up to 5 years from registration|||months||95% Confidence Interval|Median
117429|NCT00669318|Secondary|Progression-free Survival|The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration|||months||95% Confidence Interval|Median
117430|NCT00669318|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Follow-up status and retreatment information will be collected up to 5 years from registration|||months||95% Confidence Interval|Median
117431|NCT00669318|Secondary|Overall Response Rate (Complete and Partial Response)|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. A bone marrow biopsy with evidence of <30% lymphocytes and no nodules.~Patients who fulfill all criteria for a CR but have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity will be classified as CR with incomplete marrow recovery (CRi).~A Partial Response (PR) requires a 50% reduction in nodes and liver/spleen measurements and at least two of the following: absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, or a >50% reduction in lymphocytes.~Here we report the rate of overall response as the number of patients attaining a CR, PR, or CRi status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)|||percentage of patients||95% Confidence Interval|Number
117432|NCT00669318|Primary|Complete Response Rate|"A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts >1500/uL, platelets >100000/uL, Hemoglobin >11.0 g/dL, and lymphocytes <4000/uL. In addition, a bone marrow biopsy with evidence of <30% lymphocytes and no nodules.~Here we report the rate of complete response as the number of patients attaining a CR status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution."|Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)|||percentage of participants||95% Confidence Interval|Number
117433|NCT00669279|Secondary|Peripheral Blood Pressure||Measured at baseline, 2 weeks, and 4 weeks.||||||
117434|NCT00669279|Primary|Central Aortic Blood Pressure||Measured at baseline and 4 weeks.|||mmHg||Standard Error|Mean
117435|NCT00669240|Secondary|Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium|Self-administered rating of intensity of nicotine withdrawal symptoms over past 24 hours; consists of 9 questions (urge to smoke, depressed mood, irritability, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty going to sleep, difficulty staying asleep), each rated 0-4 (0=not at all, 1=slight, 2=moderate, 3=quite a bit, 4=extreme). Subscales: Negative affect domain (average of items 2-5); Insomnia domain (average of items 8 and 9); Urge to smoke (item 1); Restlessness (item 6); Increased appetite (item 7). Range 0-4 (higher score=greater intensity of symptoms)|Week 7 and Week 13 or 14 (Week 13/14)|All subjects population in Belgium; n=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
117436|NCT00669240|Secondary|Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program|"Number of participants who answered 'yes' to the question Did you register with LifeREWARDS? (LifeREWARDS not available in Greece.)"|Week 12|All-subjects population; n=number of participants with analyzable data at observation (responded to the question at the last study visit).||participants|||Number
117437|NCT00669240|Secondary|Number of Participants Who Received Varenicline, by Duration of Treatment in Days||Baseline through Week 12 or Week 24|All-subjects population; Week 24 if a maintenance period was prescribed.||participants|||Number
117438|NCT00669240|Secondary|Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12|A maintenance period was an additional period of varenicline treatment that could be prescribed at Week 12 by the attending primary care physician in routine clinical practice|Week 12|All-subjects population||participants|||Number
117439|NCT00669240|Secondary|Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11|"Responders are participants who answered no to the following 2 questions: 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days? Assessment conducted at specified time points only when usual for the local clinical practice."|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population; n=number of participants in the All-subjects population with analyzable data (responders and non-responders) who were assessed for smoking cessation at the time point (per local clinical practice) .||participants|||Number
117440|NCT00669240|Secondary|Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11|Assessment of smoking cessation (ie, not a single puff) in previous 7 days, at time points of routine review of patients per local clinical practice.|Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11|All-subjects population||participants|||Number
117441|NCT00669240|Secondary|Number of Treatment Responders in Belgium at Week 12 and at Week 24|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12 and Week 24|All-subjects population in Belgium||participants|||Number
117442|NCT00669240|Secondary|Number of Treatment Responders at Week 12|"Responders are participants who answered no to both of the following 2 questions on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?"|Week 12|All-subjects population||participants|||Number
117443|NCT00669240|Secondary|Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks|"Number of participants in Belgium who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12 and Week 24|All-subjects population in Belgium||participants|||Number
117444|NCT00669240|Secondary|Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks|"Number of participants who were determined to be a responder or a non-responder at the specified time point. (Responders are participants who answered no to both of the following 2 questions, and non-responders are participants who answered yes to at least 1 of the following 2 questions, on the Nicotine Use Inventory (NUI): 1) Has the subject smoked any cigarettes (even a puff) in the last 7 days? 2) Has the subject used any other tobacco products (for example, pipe, cigars, snuff, chew) in the last 7 days?)"|Week 12|All-subjects population||participants|||Number
117445|NCT00669240|Primary|Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)|Non-serious AEs are any untoward medical occurrence in a clinical investigation (subject administered a product or medical device) observed or volunteered through 7 days after the last dose of study drug regardless of suspected causal relationship; SAEs are any untoward medical occurrence that results in death; is life-threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity; congenital anomaly or birth defect observed or volunteered through 28 days after the last dose of study drug, regardless of suspected causal relationship.|Baseline through Week 12 or Week 24|Safety population, which is identical to the all-subjects population: all enrolled subjects who received at least 1 dose (including partial doses) of varenicline; Week 24 if a maintenance period was prescribed.||participants|||Number
117446|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 24|ITT population. N's reflect patients who received at least one dose of study drug in the open-label period.||Percentage of BSA||Standard Deviation|Mean
117447|NCT00669214|Secondary|Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks|"Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the rule of palm to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint)."|Week 12|ITT population. N's reflect patients who received at least one dose of study drug or placebo in the double-blind treatment period.||Pecentage of BSA||Standard Deviation|Mean
117448|NCT00669214|Secondary|Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks|Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient’s scalp itch on a scale of 0 to 10, where 0 was “no itching,” 5 was “moderate itching,” and 10 was “severe itching.”|Week 24|ITT population. If VAS at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 168 was missing for a patient who completed the Day 161 dose, the last available VAS was used for analysis.||Points on VAS||Standard Deviation|Mean
117449|NCT00669214|Secondary|Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks|Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient’s scalp itch on a scale of 0 to 10, where 0 was “no itching,” 5 was “moderate itching,” and 10 was “severe itching.”|Week 12|ITT population. If VAS at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If VAS at Day 84 was missing for a patient who completed treatment, the last available VAS from the treatment period was used for analysis.||Points on VAS||Standard Deviation|Mean
117450|NCT00669214|Secondary|Mean Change in Scalpdex Score at 24 Weeks|Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|Week 24|ITT population. If Scalpdex at Day 168 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 168 was missing for a patient who completed the Day 161 dose, the last available Scalpdex was used for analysis.||Points on Scalpdex||Standard Deviation|Mean
117451|NCT00669214|Secondary|Mean Change in Scalpdex Score at 12 Weeks|Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.|The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84|ITT population. If Scalpdex at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was not included in the analysis. If Scalpdex at Day 84 was missing for a patient who completed treatment, the last available Scalpdex from the treatment period was used for analysis.||Points on Scalpdex||Standard Deviation|Mean
117452|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks|Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.|Week 24|ITT population. If PGA rating at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 168 was missing for a patient who completed the Day 161 dose, the last available PGA rating was used for analysis.||Proportion of patients||95% Confidence Interval|Number
117453|NCT00669214|Secondary|Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks|"Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84)~Physician's Global Assessment (PGA) scale:~0: Clear. No signs of plaque psoriasis.~Almost clear. Just perceptible erythema and just perceptible scaling.~Mild disease. Light pink erythema with minimal scaling.~Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening.~Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening."|Week 12|ITT population. If PGA rating at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PGA rating at Day 84 was missing for a patient who completed treatment, the last available PGA rating from the treatment period was used for analysis.||Proportion of patients|||Number
117454|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.||Proportion of patients||95% Confidence Interval|Number
117455|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks|Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|ITT population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.||Proportion of patients|||Number
117456|NCT00669214|Secondary|Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 24|ITT population. If PSSI at Day 168 was missing for a patient who discontinued before the final scheduled open-label dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 168 was missing for a patient who completed the Day 161 dose, the last available PSSI was used for analysis.||Proportion of patients||95% Confidence Interval|Number
117457|NCT00669214|Primary|Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks|Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.|Week 12|Intent-to-treat (ITT) population. If PSSI at Day 84 was missing for a patient who discontinued before the final scheduled dose, the patient was considered a treatment failure (nonresponder) for analysis. If PSSI at Day 84 was missing for a patient who completed treatment, the last available PSSI from the treatment period was used for analysis.||Proportion of patients|||Number
117458|NCT00669110|Other Pre-specified|Number of Participants With Laboratory Test Results of Potential Clinical Importance (PCI)|Laboratory test results meeting the criteria for PCI categorized as bicarbonate increase or decrease from baseline of ≥4 millimoles per liter (mmol/L); hematocrit <0.32 or >0.50 (females) or <0.37 or >0.55 (males) liters per liter (L/L); high density lipoprotein (HDL) cholesterol (fasting or nonfasting / unknown) decrease >0.21 mmol/L and test value ≥1.16 mmol/L; triglycerides (fasting or nonfasting / unknown) ≥2.258 mmol/L or increase ≥1.13 mmol/L and test value ≥3.39 mmol/L; urine specific gravity <1.001 or >1.035; and positive urinalysis result for protein (albumin), hemoglobin, or ketones.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable laboratory data. Participants may be represented in >1 category.||participants|||Number
117459|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI): Heart Rate (Low)|PCI criteria for females: heart rate (bpm) ranges from <68 and >126 at age 6 to <63 and >121 at age 11; heart rate from <63 and >121 at age 12 to <54 and >110 at age 17; heart rate <50 and >104 at age 18. Criteria for males: heart rate ranges from < 68 and >126 at age 6 to <63 and >121 at age 11; heart rate <58 and >116 at age 12 up <50 and >104 at age 17; heart rate <45 and >99 at age 18. Heart rates meeting the criteria for PCI categorized as low (less than the lower limit specified for age).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data.||participants|||Number
117460|NCT00669110|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance (PCI)|ECG results meeting the criteria for PCI categorized as PR interval ≥200 milliseconds (msec); QT interval ≥480msec; QRS interval ≥120 msec; corrected QT (QTc) ≥500 msec ); >450 msec for males and >470 msec for females or increase of ≥60 msec or ≥30 msec change from baseline QTcB=QT corrected using Bazett formula; QTcF=QT corrected using the Fridericia formula.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study). N=number of participants with analyzable ECG data. Participants may be represented in >1 category.||participants|||Number
117461|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Pulse Rate|PCI criteria for females: supine pulse rate (beats per minute [bpm]) ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <63 or >121 at age 12 to <54 or >110 at age 17; pulse from <50 or >104 at age 18. Criteria for males: pulse ranges from <68 or >126 at age 6 to pulse <63 or >121 at age 11; pulse from <58 or >116 at age 12 to <50 or >104 at age 17; pulse from <45 or >99 at age 18. Vitals signs meeting criteria for PCI categorized as Low or as postural change in pulse (increase in pulse ≥20 bpm for last supine to first standing pulse [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).||participants|||Number
117462|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Weight|Vitals signs meeting the PCI criteria for weight categorized according to an increase of ≥7 percent or a decrease of ≥3.5 percent in body weight.|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).||participants|||Number
117463|NCT00669110|Other Pre-specified|Number of Participants With Vital Sign Results of Potential Clinical Importance (PCI): Blood Pressure (BP)|PCI criteria for females: systolic BP [SBP] ranges from >110 and diastolic BP [DBP] >73 (>110/73) at age 6 up to BP >124/81 at age 11; BP from >121/79 at age 12 up to BP >132/86 at age 17. Criteria for males: BP ranges from >112/73 at age 6 up to BP >123/82 at age 10; BP from >119/79 at age 11 up to BP >140/89 at age 17. Vitals signs meeting the criteria for PCI categorized as BP elevation for 3 consecutive visits or as postural change in BP (decrease in SBP ≥20 millimeters of mercury [mmHg] or in DBP ≥15 mmHg for the last supine to first standing BP [supine to standing]).|Baseline (Extension study) up to Week 26 (Extension study)|Safety population (Baseline=Extension study).||participants|||Number
117464|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Males|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Male pubertal development staged by size of the genitalia and development of pubic hair (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.||participants|||Number
117465|NCT00669110|Other Pre-specified|Change From Baseline in Number of Participants for Tanner Assessment at Week 26: Females|Tanner Children and Adolescent Pubertal Staging questionnaire used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size (test categories). Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Change categories: 0=no change in stage, 1=change of 1 stage, 2=change of 2 stages, 3=change of 3 stages, and 4=change of 4 stages. Participants may be represented in more than 1 test category.|Baseline (Extension study), Week 26 (Extension study)|Safety population (Baseline=Extension study); N=number of participants with evaluable data at observation. No participants had a change of 3 stages or change of 4 stages reported, therefore only changes for 0 stages through 2 stages are reported.||participants|||Number
117466|NCT00669110|Other Pre-specified|Percentage of Participants With a Response of Much Improved or Very Much Improved Based on the Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Participant with response is defined as having a score of 1 (very much improved) or 2 (much improved).|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.||percentage of participants|||Number
117467|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline (Core study NCT00619619), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-I score of 6 or 7 (much worse, very much worse), therefore only scores 1 through 5 (very much improved to minimally worse) are reported. CGI-I data for Inpatient Days 1 to 4 reported in Core study NCT00619619.||percentage of participants|||Number
117468|NCT00669110|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scales - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF. No participants had a CGI-S score of 5, 6 or 7 (markedly, severely, or extremely ill), therefore only scores 1 through 4 (normal to moderately ill) are reported.||percentage of participants|||Number
117469|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Hamilton Rating Scale for Depression 17-item (HAM-D17) Total Score|HAM-D17 is a clinician-rated interview to measure presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline (Extension study), Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.||scores on a scale||Standard Deviation|Mean
117470|NCT00669110|Other Pre-specified|Percentage of Participants With Remission (Total Score ≤28) Based on Children's Depression Rating Scale – Revised (CDRS-R)|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission defined as a CDRS-R total score ≤28 (coded value of 1).|Extension study Outpatient Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26, and >26 (up to Week 29)|ITT population; LOCF.||percentage of participants|||Number
117482|NCT00669032|Secondary|Mean Daily Dose of Paracetamol Consumption|Mean daily dose of paracetamol consumption throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||mg/day||Standard Deviation|Mean
117817|NCT00666562|Secondary|Levels of EGCG in Malignant Bladder Tissue||up to 28 days|Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.||ng/mL||Standard Deviation|Mean
117471|NCT00669110|Other Pre-specified|Change From Baseline (Bsl) in Children's Depression Rating Scale – Revised (CDRS-R) Total Score at Final On-therapy Visit|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 to 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline (Extension study), Extension study Outpatient Weeks 26 and >Week 26 (up to Week 29 or early termination)|Intent to Treat population (ITT): all treatment assigned participants with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after first dose in Extension study NCT00669110. Last observation carried forward (LOCF).||scores on a scale||Standard Deviation|Mean
117472|NCT00669110|Primary|Number of Participants for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Postbaseline (≥Day 1 in Core study NCT00619619) up to Week 26 (Extension study)|Safety population (Baseline=Core study) includes all treatment assigned participants with at least 1 dose of study treatment during Core study NCT00619619 and Extension study NCT00669110.||participants|||Number
117473|NCT00669110|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline (Extension study) up to Extension study Week 29 Follow up visit|Safety population (Baseline=Extension study) includes all treatment assigned participants with at least 1 dose of study treatment during Extension study NCT00669110.||participants|||Number
117474|NCT00669071|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events|Number of participants with Tolerability assessments (erythema, scaling, dryness, stinging/burning, edema, telangiectasis, darkening or melasma spots) resulting in adverse events|Baseline to week 10|Safety||participants|||Number
117475|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
117476|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Subject's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Subject's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
117477|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 10 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 10 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
117478|NCT00669071|Secondary|Number of Participants Showing Success or Failure in Improvement of Melasma at Week 6 Using the Investigator's Evaluation of Improvement|Number of participants showing success or failure in improvement of melasma at Week 6 using the Investigator's evaluation of improvement (0 = Worse, 1 = No change, 2 = Improved, 3 = Much improved, 4 = Excellent Improvement) with Improved, Much improved and Excellent Improvement defined as success and Worse or No change being defined as failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
117479|NCT00669071|Secondary|Degree of Pigmentation (Melanin) Using a Mexameter at Weeks 6 and 10|Degree of pigmentation (melanin) using a Mexameter to record units on a scale at Weeks 6 and 10; units on a scale is a number that represents the presence or absence of melanin in the skin on a scale from 0 - 999 units with 0 units representing no melanin and 999 units representing the maximum amount of melanin.|Baseline to Week 6 and Baseline to Week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||units on a scale||Standard Deviation|Mean
117480|NCT00669071|Secondary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 6 Using the Investigator's Global Assessment (IGA) of Melasma With Clear/Almost Clear Being Success and All Others Being Failure|Number of participants who were a success or failure with regards to melasma severity at Week 6 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 6|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
117481|NCT00669071|Primary|Number of Participants Who Were a Success or Failure With Regards to Melasma Severity at Week 10 as Evaluated Using the Investigator's Global Assessment (IGA) of Melasma|Number of participants who were a success or failure with regards to melasma severity at Week 10 as evaluated using the Investigator's Global Assessment (IGA) of melasma (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe) with Clear / Almost Clear being success and all others being failure|Baseline to week 10|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
117503|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||hours||Full Range|Mean
117483|NCT00669032|Secondary|Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis|Consumption of rescue medication (paracetamol/NSAID) for osteoarthritis throughout the study, an average of 40 months|Throughout the study, an average of 40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
117484|NCT00669032|Secondary|Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up|"Percentage of patients with an increase in the score of patient's global assessment by at least 20% and at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
117485|NCT00669032|Secondary|Function Improvement 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in physical function score of at least 20% or at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
117486|NCT00669032|Secondary|Overall Pain Reduction 20% (10mm) at the End of Follow-up|"Percentage of patients with a decrease in pain score of at least 20% or at least 10mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
117487|NCT00669032|Secondary|Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up|"Percentage of patients with a decrease in pain or physical function score of at least 50% and at least 20mm on the VAS at the end of follow-up.~The VAS is set between 0-100mm, higher values represent a worse outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of patients|||Number
117488|NCT00669032|Secondary|Responders OARSI 2004 at 34 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 34 months follow-up visit (6 months after fourth cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|34 months (6 months after fourth cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
117489|NCT00669032|Secondary|Responders OARSI 2004 at 27 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 27 months follow-up visit (12 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|27 months (12 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
117490|NCT00669032|Secondary|Responders OARSI 2004 at 21 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 21 months follow-up visit (6 months after third cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|21 months (6 months after third cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
117491|NCT00669032|Secondary|Responders OARSI 2004 at 14 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 14 months follow-up visit (6 months after second cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|14 months (6 months after second cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
117504|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|Plasma samples were assessed at prior to initiation of irinotecan (and l-leucovorin) infusion, 1, 2 (predose for 5-FU bolus), 4, 8, and 24 hours after initiation of irinotecan infusion, and Cmax of irinotecan and its metabolite SN-38 were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng/mL||Standard Deviation|Mean
117492|NCT00669032|Secondary|Responders OARSI 2004 at 7 Months Follow-up Visit|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at 7 months follow-up visit (6 months after first cycle). Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|7 months (6 months after first cycle)|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
117493|NCT00669032|Primary|Responders OARSI 2004 at the End of Follow-up|"Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS.~The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome."|40 months|The modified intention-to-treat population included all randomly assigned patients with at least one efficacy assessment after randomisation.||percentage of responders|||Number
117494|NCT00669019|Secondary|Progression-free Survival|Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.|Up to 2 years|||weeks||95% Confidence Interval|Median
117495|NCT00669019|Primary|Objective Response Rate|"Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum LD; Objective response = CR + PR.~CT scans will be performed at baseline and every 4-8 weeks while on study."|Up to 25 weeks|||percentage of participants||95% Confidence Interval|Number
117496|NCT00668902|Primary|DOBmax (Maximum Value of DOB)|"The stable isotope [13C]pantoprazole is O-demethylated by cytochrome P450 CYP2C19 and that the 13CO2 produced and exhaled in breath as a result can serve as a safe, rapid, and noninvasive phenotyping marker of CYP2C19 activity in vivo.~Exhaled 13CO2 and 12CO2 were measured by IR spectroscopy before (baseline) and 2.5 to 120 min after dosing. Ratios of 13CO2/12CO2 after [13C]pantoprazole relative to 13CO2/12CO2 at baseline were expressed as change over baseline (DOB)."|baseline and 2.5, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, and 120 min after dosing|||ratio||Standard Deviation|Mean
117497|NCT00668863|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 11 cycles (1 cycle = 6 weeks)|Safety analysis set was defined as the same population as the Full Analysis Set.||Participants|||Number
117498|NCT00668863|Secondary|Plasma Concentration at Steady State (Css) of 5-FU|Concentration at 22 hour post start of 5-FU infusion were to be used as Css if 5-FU concentrations suggested steady state at 22 hours time point.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng/mL||Standard Deviation|Mean
117499|NCT00668863|Secondary|Volume of Distribution at Steady State (Vss) of Irinotecan|Vss was calculated using following equation: CL x mean residence time (MRT), where MRT = the area under the first moment curve from zero time to infinity (AUMC 0-∞)/AUC 0-∞− (infusion time/2), AUMC 0-∞ = the area under the first moment curve from zero time to time t (AUMC t)+ ((t x Ct*)/ kel) + (Ct* / kel^2), AUMC t is calculated using the linear trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||L||Standard Deviation|Mean
117500|NCT00668863|Secondary|Clearance of Irinotecan|CL is calculated as dose divided by AUC 0-∞|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||L/hour||Standard Deviation|Mean
117501|NCT00668863|Secondary|Terminal Phase Elimination Half-life (t1/2) of Irinotecan|Terminal phase half-life of irinotecan was calculated as ln 2/ kel.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||hours||Standard Deviation|Mean
117502|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan|"AUC last of irinotecan and its metabolite SN-38 were calculated using the Linear/Log trapezoidal method.~AUC∞ of irinotecan was calculated using following equation; AUC last+(C*t/kel), where Ct* is the estimated concentration at the time of the last quantifiable concentration, kel is terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile."|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng.h/mL||Standard Deviation|Mean
117505|NCT00668863|Secondary|Apparent Oral Clearance (CL/F) of Sunitinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||L/hour||Standard Deviation|Mean
117506|NCT00668863|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib|AUC 0-24 was determined using the Linear/Log trapezoidal method.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng.h/mL||Standard Deviation|Mean
117507|NCT00668863|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib||Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||hours||Full Range|Mean
117508|NCT00668863|Secondary|Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.|Plasma concentrations were assessed at predose, 2, 4, 6, 8, and 24 hours postdose and Cmax and Ctrough of sunitinib, its metabolite SU012662, and the total (sunitinib + SU0122662) were determined.|Cycle 1 Day 15|Analysis set was consisted of participants who provided an evaluable sample. Planned number of participants for pharmacokinetic analysis was 6.||ng/mL||Standard Deviation|Mean
117509|NCT00668863|Secondary|Duration of Response (DR)|DR is defined as the time from the first objective documentation of complete or partial response that is subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurs first. The definition of censorship is the same as PFS.|Up to 11 cycles (1 cycle = 6 weeks)|Analysis set was consisted of participants with a confirmed objective tumor response (CR or PR) among Full Analysis Set.||weeks||95% Confidence Interval|Median
117510|NCT00668863|Secondary|Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)|ORR is defined as the percentage of participants with best overall response of either a confirmed complete (CR) or partial response (PR) relative to the number of participants in FAS. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.||percentage of participants||95% Confidence Interval|Median
117511|NCT00668863|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause. OS data was censored on the day following the date of the last contact at which the patient is known to be alive.|Up to 11 cycles (1 cycle = 6 weeks)|Median OS was not calculable due to the large number of censored events (63 out of 71 were censored).||weeks||95% Confidence Interval|Median
117512|NCT00668863|Primary|Progression-Free Survival (PFS)|"PFS is defined as the time from the date of enrollment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first.~PFS data was censored on the day following the date of the last tumor assessment documenting absence of progressive disease for patients who 1) were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression; 2) were removed from the study prior to documentation of objective tumor progression; and 3) were ongoing at the time of the analysis."|Up to 11 cycles (1 cycle = 6 weeks)|Full Analysis Set was defined as all enrolled subjects who met the following criteria :1) Those who were diagnosed as having adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease and 2) those who received at least one dose of the study medication.||weeks||95% Confidence Interval|Median
117513|NCT00668785|Secondary|Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point||March 2010||||||
117514|NCT00668785|Secondary|Mean Change From Pre-PRP Optical Coherence Tomography (OCT) in Central Foveal Thickness and Macular Volume as Assessed by OCT at 1, 2 and 3 Months.||March 2010||||||
117515|NCT00668785|Primary|Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.)|No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.|March 2010||||||
117516|NCT00668746|Secondary|Micocycline-Resistance From Saliva Sample|Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects|Baseline, Day 30 and Day 180|ITT||Percentage of Subjects|||Number
117517|NCT00668746|Secondary|Micocycline-Resistance From Plaque Samples|Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples|Baseline, Day 30 and Day 180|ITT||Percentage of Subjects|||Number
117518|NCT00668746|Primary|Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture|Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.|from Baseline to Day 30 and Day 180|intention to treat (ITT)||Percentage Change||Standard Deviation|Mean
117519|NCT00668733|Primary|Number of Participants With Recurrence of AK Lesions|The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.|Up to one year|Efficacy analyses were conducted on the evaluable subject population defined as all subjects who were eligible and enrolled in the follow-up study. All results were summarized overall and by original Phase 3 randomized treatment regimen and dose group. Actinic keratosis recurrence was categorized by presence or absence only.||participants|||Number
117520|NCT00668564|Secondary|Overall Survival|Number of patients alive at timepoints.|Day 100, 1 Year, 3 Years|Year 3 survival endpoint was not done due to study being terminated prematurely.||Participants|||Number
117521|NCT00668564|Primary|Number of Patients Achieving Engraftment|Rate of successful engraftment - patients who achieved and sustained donor engraftment; donor chimerism by day 100 of at least 90% after undergoing hematopoietic stem cell transplantation.|Day 100|||Participants|||Number
117522|NCT00668525|Secondary|Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8|The HAMD is a clinician-rated 24-item scale was used to rate the patient’s depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).|Change from baseline in HAM-D at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline HAMD total score as a covariate.||Units on a scale||Standard Error|Mean
117523|NCT00668525|Primary|Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.|The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).|Change from baseline in MADRS total score at week 8|The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline MADRS total score as a covariate.||Units on a scale||Standard Error|Mean
117524|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 52 follow-up|||units on a scale||Standard Error|Mean
117525|NCT00668434|Secondary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 52 follow-up|||units on a scale||Standard Error|Mean
117526|NCT00668434|Secondary|Pain Numerical Rating Scale|Ordinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.|Baseline, Week 3 follow-up|||units on a scale||Standard Error|Mean
117527|NCT00668434|Primary|Oswestry Disability Index, v2|The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.|Baseline, Week 3 follow-up|||units on a scale||Standard Error|Mean
117528|NCT00668395|Primary|Effect of CYP2B6 Genotype on Efavirenz Clearance|Efavirenz clearance is a measure of rate of elimination of the drug from the body. We used this measure to evaluate differences in rate of elimination of efavirenz at a single dose and after multiple dosing within three CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and CYP2B6*6/*6). Efavirenz clearance was measured in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6) and slow metabolizer (CYP2B6*6/*6) at a single 600 mg oral dose of efavirenz and then after multiple dosing (autoinduction), i.e., the administration of efavirenz (600 mg/day) for 17 days. Single and multiple dose efavirenz clearance was measured and compared to determine the extent of autoinduction within this genotype group.|Efavirenz clearance at single dose and multiple dose stratified by CYP2B6 genotypes|||ml/h/kg||Standard Deviation|Mean
117529|NCT00668382|Primary|Number of Subjects With Greater Than Grade 3 or 4 Toxicity|Grade 3/4 Toxicity occurring in a participant within a month of intratumoral injection|1 month|Dose escalating Phase 1 scheme: three participants for each dose cohort. The second patient in the last (10 mg) dose cohort developed and adverse event (infection at injection site) and so three more participants were entered and analyzed at that dose||participants|||Number
117530|NCT00668317|Secondary|Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire||8 weeks||||||
117531|NCT00668317|Primary|Change in Methacholine Sensitivity|"Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20).~To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine"|baseline and 8 weeks|All subjects recruited with efficacy data recorded after week T0 will be included in the ITT population for analysis. Assuming a within subject standard deviation(for change in PC20) of no more than 2.71 units, 30 subjects are sufficient to provide 80% power to detect a treatment difference of 1.8 units using a 5% two sided significance test||mg/ml||Standard Deviation|Mean
117532|NCT00668265|Secondary|Beck Depression Inventory at 16 Weeks|To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.|16 weeks|Data were not analyzed. PI left institution, and did not respond to attempts top contact him.|||||
117533|NCT00668265|Primary|Hamilton Anxiety Scale at 16 Weeks|Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety|16 weeks|Data was not analyzed: PI left the institution and the study was terminated|||||
117534|NCT00668200|Secondary|Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)|The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.|End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.||percentage of patients|||Number
117548|NCT00667992|Primary|PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)|"Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.~The ratio of Methacholine concentration measured at 2 weeks to that at Baseline."|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Ratio||95% Confidence Interval|Geometric Mean
117535|NCT00668200|Secondary|Change From Baseline in Serum Calcium (mmol/L) – Safety Population|Change from baseline = endpoint – baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.|Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|This Outcome Measure uses Safety population which includes 81 patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety. The ITT population was used for participant flow and baseline characteristics.||mmol/L||Standard Deviation|Mean
117536|NCT00668200|Primary|Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.|To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium <2.07 mmol/L at 9-11 days after the study drug infusion.|at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)|Safety population which includes 81 patients was used. 75 of the 81 patients in the safety population met the criteria. 6 patients did not meet criteria and were excluded from the analysis: 1 patient had a low serum calcium at baseline, and the other 5 patients were missing serum calcium values either at baseline or post-baseline.||percentage of patients|||Number
117537|NCT00667992|Secondary|Peak Exploratory Flow (PEF) Morning|Peak Exploratory Flow (PEF) recorded daily in the morning|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters/minutes||95% Confidence Interval|Least Squares Mean
117538|NCT00667992|Secondary|Rescue Medication Total|The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Number of inhalations/24 hours||95% Confidence Interval|Least Squares Mean
117539|NCT00667992|Secondary|Rescue Medication Evening|The average of means for inhalations of rescue medication in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Number of inhalations||95% Confidence Interval|Least Squares Mean
117540|NCT00667992|Secondary|Rescue Medication Morning|The average of means for inhalations of rescue medication in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Number of inhalations||95% Confidence Interval|Least Squares Mean
117541|NCT00667992|Secondary|Asthma Symptom Score Total|Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Units on a scale||95% Confidence Interval|Least Squares Mean
117542|NCT00667992|Secondary|Asthma Symptom Score Evening|Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Units on a scale||95% Confidence Interval|Least Squares Mean
117543|NCT00667992|Secondary|Asthma Symptom Score Morning|Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.|2 weeks|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Units on a scale||95% Confidence Interval|Least Squares Mean
117544|NCT00667992|Secondary|eNO (Exhaled Nitrogen Oxide)|eNO ratio of baseline|baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Ratio||95% Confidence Interval|Geometric Mean
117545|NCT00667992|Secondary|FEF 25-75 (Forced Expiratory Flow 25-75)|FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline|Baseline and week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters/seconds||95% Confidence Interval|Least Squares Mean
117546|NCT00667992|Secondary|FEV1 (Forced Expiratory Volume in 1 Second)|FEV1 change from baseline|Baseline to week 2|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters||95% Confidence Interval|Least Squares Mean
117547|NCT00667992|Secondary|Peak Exploratory Flow (PEF)|Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.|Baseline to week 2 recorded daily|Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).||Liters/minutes||95% Confidence Interval|Least Squares Mean
117549|NCT00667875|Secondary|Percent Heavy Drinking Days Over the 16-week Study||16-weeks||||||
117550|NCT00667875|Secondary|Subject-reported Adverse Events on the SAFTEE Interview||16-week||||||
117551|NCT00667875|Secondary|Pill Counts and Urinary Riboflavin Levels During Treatment||16-week||||||
117553|NCT00667849|Other Pre-specified|Treatment Compliance|The percent of subjects who used the device greater than or equal to 18 minutes per day over 80% of the days in their treatment period.|Treatment period: Days from randomization to day of x-ray assessed healed or, if not heal, day of premature withdrawal/study termination or day 365 (end of study visit)|FAS with compliance data (subjects who returned the device)||percentage of compliant participants|||Number
117554|NCT00667849|Primary|Time (Days) to Radiographic Healing of Tibial Fractures|Days from randomization to day of x-ray assessed healed or, if not healed, day of premature withdrawal/study termination or day 365 (end of study visit)/ Kaplan-Meier|over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.||days||Inter-Quartile Range|Median
117555|NCT00667849|Primary|Change From Baseline in the SF-36 Physical Component Summary (PCS) Score of the Short Form-36 (SF-36)|Assessments at baseline and 6 post baseline time points/ mixed effects repeated measure single point estimate. Range= -100 worst, 0 best|Over 365 days|Full Analysis Set (FAS) is all subjects randomized with at least one post treatment set of adjudicated x-rays.||units on a scale||95% Confidence Interval|Least Squares Mean
117556|NCT00667810|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78|The CDR-SOB is a global clinical staging instrument that sums 6 clinical ratings: 1) memory, 2) orientation, 3) judgment and problem solving, 4) involvement in community affairs, 5) home and hobbies, and 6) personal care based on the Clinical Dementia Rating Scale (CDR) interview. The CDR includes discussions with the participant and caregiver using a structured format. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. CDR-SOB total score range is 0 (least impairment) to 18 (most impairment); a negative change from baseline indicates an improvement.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
117557|NCT00667810|Secondary|Change From Baseline in Dependence Scale Total Score at Week 78|The Dependence Scale (DS) is a 13-item, caregiver-rated instrument for determining the amount of support required by a participant with AD. The DS total score ranges from 0 to 15, with higher scores indicating more need for assistance. The DS was administered as an interview to the caregiver at scheduled study visits.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
117558|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was <12.|78 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants|||Number
117559|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose decrease (worsening) from baseline to Week 78 in DAD total score was at most 0, 6, 12 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants||95% Confidence Interval|Number
117560|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)|Percentage of participants whose increase (worsening) from baseline to Week 78 in ADAS-Cog/11 total score is <7.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Percentage of participants|||Number
117561|NCT00667810|Secondary|Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (European Union Analysis Plan)|Percentage of participants whose increase (worsening) in ADAS-Cog/11 total score from baseline to Week 78 was at most 0, 3, 7 points.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Number of participants||95% Confidence Interval|Number
117562|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis Plan)|The time to first clinically meaningful deterioration was defined as the first time a participant experienced a decrease (worsening)from baseline in DAD total score of >=12.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
117563|NCT00667810|Secondary|Time to Median Placebo Deterioration on DAD Total Score|The time to first median placebo deterioration (for the EU) was defined as the first time a participant experienced a decrease (worsening) in DAD total score greater than or equal to the median worsening at Week 78 in the placebo group.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
117564|NCT00667810|Secondary|Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)|The time to first clinically meaningful deterioration (for the US) was defined as the first time a participant experienced an increase (worsening) from baseline in ADAS-Cog/11 total score of >=7.|78 weeks|||Days||95% Confidence Interval|Median
117588|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (subjects enrolled in Australia).||Titers||95% Confidence Interval|Geometric Mean
117565|NCT00667810|Secondary|Time to Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)|The time to first median placebo deterioration (for the EU) was defined as the first time a subject experienced an increase from baseline (worsening) in ADAS Cog/11 total score greater than or equal to the median worsening observed at Week 78 in the placebo group. The Kaplan Meier estimate of the median time to first median placebo deterioration in ADAS Cog/11 total score was presented.|78 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Days||95% Confidence Interval|Median
117566|NCT00667810|Secondary|Divergence of Effect on the DAD Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts)of the differences between bapineuzumab and placebo for the DAD total scores from Week 39 to Week 78 was presented.|39 weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Years||Standard Error|Mean
117567|NCT00667810|Secondary|Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78|The MMRM estimated slope (based on linear contrasts) of the differences between bapineuzumab and placebo for the ADAS-Cog/11 total scores from Week 39 to Week 78 was presented.|39 Weeks|The mITT included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units/Year||Standard Error|Mean
117568|NCT00667810|Secondary|The Change From Baseline in Brain Volume at Week 71|Brain volume was examined in a subset of participants by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI). Cerebral atrophy correlates closely with the gradual cognitive decline in AD and can be visualized by MRI. The BBSI technique involves positional matching of serial 3-dimensional MRI brain images, such that brain MRI-image volumes were first registered and then subtracted from each other. Atrophy rates would generally be expected to be lower if the underlying disease was attenuated by effective treatment.|71 Weeks|The vMRI population Included all randomized participants who enrolled in the vMRI substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline vMRI that passed quality control and was satisfactory for volumetric analysis.||mL/year||Standard Error|Least Squares Mean
117569|NCT00667810|Secondary|The Change From Baseline in Phospho-tau Levels in the Cerebrospinal Fluid (CSF) at Week 71.|Biomarkers CSF phospho-tau (p-tau) is an indicator of neuronal injury and neurodegeneration. An elevation in levels of tau, as well as specific p-tau species, is thought to be a marker for progressive cellular degeneration in AD. Accordingly, a reduction from baseline in levels of CSF tau in participants who received bapineuzumab compared with participants who received placebo may be indicative of a reduction in neuronal loss in participants treated with bapineuzumab.|71 Weeks|CSF population included all randomized participants who enrolled in the CSF substudies, received at least one infusion or portion of an infusion of study drug, and had a baseline and at least one postbaseline CSF measurement (CSF phospho-tau).||pg/mL||Standard Error|Least Squares Mean
117570|NCT00667810|Secondary|The Change From Baseline in Brain Amyloid Burden at Week 71.|Brain amyloid burden as imaged by 11C-Pittsburgh compound B (PiB) positron emission tomography (PET). The latter is a semiquantitative measure of the extent of fibrillar amyloid in the brain. PIB PET measurements were made in cortical regions found to have the highest burden of fibrillar amyloid at autopsy in participants diagnosed as having Alzheimer’s pathology, and also regions reported to have the highest average retention of PIB signal in previous PET studies enrolling participants with probable AD. This parameter reflects overall brain amyloid deposition as indexed by imaging. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by PIB PET imaging in a subset of participants.|71 Weeks|PiB PET population included all randomized participants who enrolled in the PET substudies and who met the following criteria: a) received at least one infusion or portion of an infusion of study drug, b) had a baseline and at least one post baseline PiB PET assessment, and c) had an SUVr for the global cortical average (GCA) ROI≥1.35 at baseline.||SUVr||Standard Error|Least Squares Mean
117571|NCT00667810|Primary|The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified global rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement.|78 weeks|The Modified Intent-to-Treat (mITT) population included as all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and DAD total score.||Units on a scale||Standard Error|Least Squares Mean
117586|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
117587|NCT00667602|Secondary|Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).|6-18 months postvaccination.|Analysis was done on PP set (only for subjects enrolled in Australia).||Titers||95% Confidence Interval|Geometric Mean
117572|NCT00667810|Primary|The Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)/11 Total Score at Week 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|78 weeks|The modified intent-to-treat (mITT) included all randomized participants who received at least one infusion or portion of an infusion of study drug and who had a baseline and at least one post-baseline assessment of the ADAS-Cog/11 total score and Disability Assessment for Dementia (DAD) total score.||Units on a scale||Standard Error|Least Squares Mean
117573|NCT00667745|Secondary|Suicidality||Measured over 6 months||||||
117574|NCT00667745|Secondary|Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)||Measured over 6 months||||||
117575|NCT00667745|Secondary|Symptoms as Measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) and the Young Mania Rating Scale (YMRS)||Measured over 6 months||||||
117576|NCT00667745|Primary|Number of Necessary Medication Adjustments|"Metric Definition (Necessary Clinical Adjustments (NCA)): Medication adjustments to reduce symptoms, optimize treatment response and functioning, or to address intolerable side effects. This was determined with the Medication Recommendation Tracking Form (MRTF), a novel method for capturing physician prescribing behavior and clinical decision making.~Range: whole numbers~Relevant time points: Weeks 2, 4, 6, 8, 12, 16, 20, and 24."|Measured over 6 months|||Adjustments||Standard Deviation|Mean
117577|NCT00667745|Primary|Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score|"Scale: Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Construct: This scale holistically measures severity of a participant’s depression, mania, and overall illness.~Range: 0- not assessed, 1-normal (not at all ill), 2- borderline mentally ill, 3- mildly ill, 4- moderately ill, 5- markedly ill, 6- severely ill, 7- among the most extremely ill patients."|Relevant time points: baseline and week 24|||units on a scale||Standard Deviation|Mean
117578|NCT00667732|Secondary|The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment|efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%|After 24 weeks of randomized treatment|Per protocol, all participants who completed treatment||percentage of participants|||Number
117579|NCT00667732|Primary|The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment||After 24 weeks of randomized treatment|Intent to treat. All participants randomized to treatment.||percentage of participants|||Number
117580|NCT00667693|Secondary|Secondary Outcomes Will Include Ease of Intubation (as Recorded by the Operator Immediately After Intubation on a 100 mm Visual Analog Scale [VAS]), the Number of Failures, the Number of Attempts Made, and the Amount of Bleeding That Occurred.||intraoperative, first post op morning||||||
117581|NCT00667693|Primary|Time to Intubation|time between sufficient muscle relaxant and placement of intubation tube|time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds|||seconds||Inter-Quartile Range|Median
117582|NCT00667602|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination|"Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.~safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups"|From day 1 to day 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
117583|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.~Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
117584|NCT00667602|Secondary|Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C|"Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C."|1 month postvaccination.|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
117585|NCT00667602|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y|"Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.~Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
117808|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
117589|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).|1 month postvaccination 6-18 months postvaccination|Analysis was done on PP set (persistence subset).||Percentages of subjects||95% Confidence Interval|Number
117590|NCT00667602|Secondary|Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C|Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).|1 month postvaccination and 6-18 months postvaccination.|Analysis was done on PP set (persistence subgroup).||Percentages of subjects||95% Confidence Interval|Number
117591|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)|"To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.~Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL."|1 month postvaccination|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
117592|NCT00667602|Secondary|Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)|"The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.~For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.~Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.~Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8.~HepB (HBV): primary endpoint ELISA >=10mU/mL.~PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL."|1 month postvaccination|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
117593|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y|"The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.~The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y."|1 month postvaccination|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
117594|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y|Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.|1 month postvaccination|Analysis was done on PP set.||Titers||95% Confidence Interval|Geometric Mean
117595|NCT00667602|Secondary|Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.||Titers||95% Confidence Interval|Mean
117596|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y|"Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y.~Serogroup C is not shown here as it is shown in other outcome measures."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
117597|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y|"Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C.~Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y."|1 month postvaccination.|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
117598|NCT00667602|Secondary|Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.|1 month postvaccination|Analysis was done on PP set.||Percentages of subjects||95% Confidence Interval|Number
117599|NCT00667602|Primary|Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C|Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.|1 month postvaccination|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
117618|NCT00667511|Primary|Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).|Study Week 20|Includes all electronically captured treatments.||percentage of successful treatments|Participants|95% Confidence Interval|Number
117600|NCT00667589|Secondary|Change in Skindex-16 Total Score Between Baseline and 2 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 2 weeks.|baseline and 2 weeks|Results for one subject from the Tazarotene 0.1% cream arm and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not completed a Skindex-16 questionnaire at 2 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.||units on a scale||Standard Deviation|Mean
117601|NCT00667589|Primary|Change in Skindex-16 Total Score Between Baseline and 8 Weeks|The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.|baseline and 8 weeks|Results for subjects from the fluocinonide 0.05% cream arm, subjects from the Tazarotene 0.1% cream arm, and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not complete a Skindex-16 questionnaire at 8 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.||units on a scale|||Number
117602|NCT00667576|Secondary|Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH values ≤ 180 pg/mL. Missing data were not imputed.||days||Standard Deviation|Mean
117603|NCT00667576|Secondary|Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values||Through Week 13|Includes subjects from the Full Analysis Set (FAS) who had 2 consecutive iPTH decreases of ≥ 50% from baseline. Missing data were not imputed.||days||Standard Deviation|Mean
117604|NCT00667576|Secondary|Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level||Through Week 13|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated subjects, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||Percentage of participants|||Number
117605|NCT00667576|Secondary|Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL)||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||Percentage of participants|||Number
117606|NCT00667576|Secondary|Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||pg/mL||95% Confidence Interval|Mean
117607|NCT00667576|Other Pre-specified|Percentage of Subjects With Hyperphosphatemia|Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.||Percentage of participants|||Number
117608|NCT00667576|Other Pre-specified|Percentage of Subjects With Hypercalcemia|Hypercalcemia was defined as at least 1 adjusted calcium value > 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL|Through Week 13|Safety analysis was performed on the Safety Set, which included all subjects who received at least 1 dose of study drug. Missing data were not imputed.||Percentage of participants|||Number
117609|NCT00667576|Primary|Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level||Baseline to Week 13 (Final Visit)|The efficacy analysis was performed on the full analysis set (FAS). The FAS included all treated patients, except for 1 subject from the paricalcitol 4 ± 2 µg group who discontinued the study without measurement of iPTH after the first drug injection. Missing data were not imputed.||Percentage of participants|||Number
117610|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-18|Detectable antibodies to HPV-18 among participants with undetectable antibodies to HPV-18 at baseline|28 weeks|Per-protocol population of participants with undetectable HPV-18 antibodies at baseline||participants|||Number
117611|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-11|Detectable antibodies to HPV-11 among those who had undetectable antibodies to HPV-11 at baseline|28 weeks|Per-protocol population of participants with undetectable antibodies for HPV-11 at baseline||participants|||Number
117612|NCT00667563|Primary|Number of Patients With Detectable Antibodies to HPV-6|Detectable antibodies to HPV-6 among participant who had undetectable antibodies to HPV-6 at baseline|28 weeks|Per-protocol participants with undetectable antibodies to HPV-6 at baseline||participants|||Number
117613|NCT00667563|Primary|Number of Patients With a Significant Increase in HIV Viral Load|Number of patients with a significant increase in HIV viral load defined as > 1 log increase in HIV load from baseline on 2 consecutive occasions|Screening/week 0, weeks, 2, 10, 26 and 52|||participants|||Number
117614|NCT00667563|Primary|Number of Patients With Detectable HPV Antibodies to HPV 16 at Week 28|Number of participants with detectable HPV antibody to HPV 16 among those with undetectable antibodies to HPV 16 at baseline|Week 28|Per-protocol population with undetectable HPV-16 levels at baseline||participants|||Number
117615|NCT00667563|Primary|Number of Patients With Significant Decrease (at the 0.05 Significance Level) in CD4+ Cell Count|Significant decrease (at the 0.05 significance level) in CD4+ cell count to 75% of the baseline level on two or more consecutive tests|Screening/Week 0, Weeks 2, 10, 26, and 52.|Intent-to-treat||participants|||Number
117616|NCT00667563|Primary|Safety, in Terms of Grade 3 or 4 Adverse Events Attributed to the Vaccine, According to NCI CTCAE v3.0|Number of grade 3 or 4 adverse events attributed to vaccine per 100 patients|52 weeks from study entry|Intent-to-treat||Grade 3/4 adverse events per 100 patient||95% Confidence Interval|Number
117617|NCT00667511|Primary|Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.|The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.|Study Week 20|Includes all patient reported treatments.||events per 100 treatments|Participants||Number
117619|NCT00667459|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable MCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||units on a scale||Standard Deviation|Mean
117620|NCT00667459|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable PCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||units on a scale||Standard Deviation|Mean
117621|NCT00667459|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain score at both baseline and 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.||units on a scale||Standard Deviation|Mean
117622|NCT00667459|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||units on a scale||Standard Deviation|Mean
117623|NCT00667459|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||units on a scale||Standard Deviation|Mean
117624|NCT00667459|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level.|24 months post-operation|For this endpoint, the analysis consists of all subjects in the primary analysis dataset with 280 subjects in the investigational control and 265 subjects in the control group.||percentage of participants|||Number
117625|NCT00667459|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for hospital stay, which leads to 280 subjects in the investigational group and 265 subjects in the control group.||days||Standard Deviation|Mean
117626|NCT00667459|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for blood loss, which leads to 278 subjects in the investigational group and 263 subjects in the control group.||ml||Standard Deviation|Mean
117627|NCT00667459|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for operative time, which leads to 280 subjects in the investigational group and 265 subjects in the control group.||hrs||Standard Deviation|Mean
117628|NCT00667459|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.||percentage of participants|||Number
117629|NCT00667459|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||percentage of participants|||Number
121741|NCT00627406|Primary|Frequency of Moderate to Severe OHSS.||From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test|No power calculation was proformed.||participants|||Number
117630|NCT00667459|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.||percentage of participants|||Number
117631|NCT00667459|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.||percentage of participants|||Number
117632|NCT00667459|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||percentage of participants|||Number
117633|NCT00667459|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 224 subjects in the investigational group and 164 subjects in the control group.||percentage of participants|||Number
117634|NCT00667459|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.||percentage of participants|||Number
117635|NCT00667459|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.||percentage of participants|||Number
117636|NCT00667459|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative;~Maintenance or improvement in neurological status;~Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of “Postoperative Height - 6 Week Postoperative Height ≥ -2mm”;~No serious adverse event classified as implant associated or implant/surgical procedure associated; and~No secondary surgical procedure classified as a failure."|24 months|The primary analysis dataset for this study consists of all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 226 investigational subjects and 171 control subjects.||percentage of participants|||Number
117637|NCT00667446|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age|"Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula:~(BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline)."|Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36|Intention-to-treat with available bone age data. N = participants with available data at each time point.||ratio||Standard Deviation|Mean
117638|NCT00667446|Secondary|Change From Baseline in Growth Rate|Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.|Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36|Intention-to-treat with available growth rate data. N = participants with available data at each time point.||cm/year||Standard Deviation|Mean
117652|NCT00667394|Primary|Progression-free Survival at 6 Months|Percentage of participants with progression free survival at 6 months. Progression is defined as a 25% increase in the sum of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease), clear worsening of any evaluable disease, appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|||Percentage of participants||95% Confidence Interval|Median
120180|NCT00642304|Secondary|Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP|The EEP was defined as Week 16 to Week 24.|EEP (Weeks 16 to 24)|ITT population||Percentage of participants||95% Confidence Interval|Number
117639|NCT00667446|Secondary|Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)|The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat male population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
117640|NCT00667446|Secondary|Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)|The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.|Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36|Intention-to-treat female population, excluding participants who entered the study at Stage 5. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
117641|NCT00667446|Secondary|Mean Peak-stimulated Luteinizing Hormone Concentration by Visit|Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.|Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36|Intention-to-treat. N = the number of participants with available data at each time point.||mIU/mL||Standard Deviation|Mean
117642|NCT00667446|Secondary|Percentage of Male Participants With Suppression of Basal Testosterone|The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone < 30 ng/dL. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 3, 6, 9, 12, 24, 30, and 36|Intention-to-treat male population. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
117643|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.~The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36."|Months 6, 9, 12, 24, 30, and 36|Intention-to-treat female population. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
117644|NCT00667446|Secondary|Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)|"The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol < 20 pg/mL.~The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36."|Day 1, Months 3, 6, 9, 12, and 24|Intention-to-treat female population. N = the number of participants with available data at each time point.||percentage of participants||95% Confidence Interval|Number
117645|NCT00667446|Primary|Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone|Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH < 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.|Day 1, Months 6, 12, 24, and 36|Intention-to-treat, defined as patients who received at least 1 dose of study drug with at least 1 post-baseline measurement of any maintenance of suppression variable, & did not prematurely discontinue in the 1st 30 days due to inadequate suppression at Month 6 of the lead-in study. N= the number of patients with available data at each time point.||percentage of participants||95% Confidence Interval|Number
117646|NCT00667420|Secondary|Overall Survival|Overall survival (OS) is the duration from start of treatment to time of death from any cause.|duration from enrollment to death (up to 6 years)|||months||95% Confidence Interval|Median
117647|NCT00667420|Secondary|Pathologic Complete Response Rate|For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined.|at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)|||participants|||Number
117648|NCT00667420|Secondary|Progression-Free Survival|measured from the first day of treatment to the day when conclusive evidence of new disease is found|up to 72 months|We enrolled 17 patients||months||Standard Deviation|Mean
117649|NCT00667420|Secondary|R0 Resection Rate|percentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection|time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapy|||percentage of participants|||Number
117650|NCT00667420|Primary|Safety and Tolerability|Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy|after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)|||participants|||Number
117651|NCT00667394|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|45 months|||Participants|||Number
121742|NCT00627393|Secondary|Discontinuation of Granulocyte Transfusions Due to Toxicity or Intolerance||Measured through Day 42||||||
117653|NCT00667381|Other Pre-specified|Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations|Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population.|At angiogram analysis|||participants|||Number
117654|NCT00667381|Secondary|Number of Participants With Vascular Complications|"Vascular complications were defined as vessel thrombosis, dissection, blood transfusion, hematoma > 5cm diameter, unexplained bleeding with a drop in Hgb >4 g/dL, or access site bleeding with drop in Hgb >3 g/dL.~Outcome was assessed by chart review, and clinical or telephone followup at 30 days. Medical records were adjudicated by a blinded independent review committee."|Immediate and up to 1 month after procedure.|||participants|||Number
117655|NCT00667381|Secondary|Number of Patients With Accidental Femoral Venipunctures.|"Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted.~Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients."|Immediate|||participants|||Number
117656|NCT00667381|Secondary|Time to Successful Sheath Insertion.|"Time was measured from first fluoroscopy of the femoral head (control group), or first application of the ultrasound probe (ultrasound group), until successful sheath insertion.~Time was not recorded for 1 control patient, and 1 ultrasound patient, these patients were excluded from this analysis but included for other analyses."|Immediate|||seconds||Standard Deviation|Mean
117657|NCT00667381|Primary|Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography|"Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses.~Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers."|Immediately, during procedure.|||participants|||Number
117658|NCT00667368|Secondary|Percentage of Women Testing Positive for Bacterial Vaginosis (BV) Through 12 Months|Percentage of women testing positive for BV at any follow-up visit. The outcome of BV status was determined by self-collected vaginal swab specimens that were evaluated by the Nugent criteria. A Nugent score of 7-10 indicates positive for BV.|2, 4, 6, 8, 10, 12 months after enrollment|All randomized participants||percentage of participants|||Number
117659|NCT00667368|Primary|One-year Incidence of Chlamydial and Gonococcal Infections in Women Who Receive Screening (Every 2 Months) and Treatment for Asymptomatic Bacterial Vaginosis as Compared to a Control Group With Regular Monitoring (Every 2 Months) But no Treatment|Chlamydia and gonococcal infections were determined by vaginal swab testing collected at 4, 8, and 12 months after enrollment. Specimens were evaluated using the BD ProbeTec Amplified DNA AssayTM (Becton-Dickson, Inc. Sparks, MD). The primary outcome measure is the combined number of chlamydia and gonococcal infections.|At 4, 8, and 12 months after enrollment.|||Number infections per 100 person-years||95% Confidence Interval|Number
117660|NCT00667355|Secondary|Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These are summarized in a physical component summary (PCS) and mental component summary (MCS) score. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=lowest level of functioning; 100=highest level of functioning).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||units on scale||95% Confidence Interval|Mean
117661|NCT00667355|Secondary|Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)|The number of tender or painful joints among 23 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender or painful joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender or painful joints) to 46 (worst possible score; all joints tender or painful).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||TJC||95% Confidence Interval|Mean
117662|NCT00667355|Secondary|Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||SJC||95% Confidence Interval|Mean
117663|NCT00667355|Secondary|Mean Change From Baseline in Nocturnal Pain|Nocturnal pain assessed by subjects using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = worst possible pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mm on scale||95% Confidence Interval|Mean
117664|NCT00667355|Secondary|Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||units on a scale||95% Confidence Interval|Mean
117665|NCT00667355|Secondary|Mean Change From Baseline in Chest Expansion|Chest expansion is the difference in centimeters between full expiration and full inspiration, measured at the 4th inter-costal space. An increase in chest expansion represents improvement.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||cm||95% Confidence Interval|Mean
117708|NCT00667186|Primary|Percentage of Tested Participants Newly Diagnosed as HIV Infected|Percentage of tested participants newly diagnosed as HIV infected|3 years|participants analyzed is restricted to the participants that consented to testing||percentage of tested that are positive|||Number
117666|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total score ranging from 0 to 10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||units on scale||95% Confidence Interval|Mean
117667|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission|Partial remission is defined as a score of less than 20 units (on a scale of 0–100; 0=no disease activity and 100=high disease activity) in each of the 4 Assessments in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
117668|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = at least 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
117669|NCT00667355|Secondary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains (each domain measured on a 0 - 100 scale [0 = no disease activity; 100 = high disease activity]).|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
117670|NCT00667355|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP)|CRP is a marker of inflammation and measured in mg/dL. A higher level is consistent with inflammation.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mg/dL||95% Confidence Interval|Mean
117671|NCT00667355|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS subjects. Utilizing a VAS of 0–100 mm (0=easy, 100=impossible), subjects answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on last observation carried forward (LOCF).||mm on scale||95% Confidence Interval|Mean
117672|NCT00667355|Secondary|Mean Change From Baseline in Total Back Pain|Subject assessed his/her back pain by using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = no pain and 100 = most severe pain).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mm on scale||95% Confidence Interval|Mean
117673|NCT00667355|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity|Subject's assessment of disease activity using a Visual Analog Scale (VAS) of 0 – 100 mm (0 = none and 100 = severe).|Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on LOCF.||mm on scale||95% Confidence Interval|Mean
117674|NCT00667355|Secondary|Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)|BASDAI is a validated self assessment tool used to determine disease activity in subjects with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
117675|NCT00667355|Secondary|Number of Subjects Achieving ASAS 70|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = at least 70% improvement (vs. baseline) and an absolute improvement ≥ 30 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
117676|NCT00667355|Secondary|Number of Subjects Achieving ASAS 50|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = at least 50% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on NRI, for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
117677|NCT00667355|Secondary|Number of Subjects Achieving ASAS 20|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Weeks 12, 24, 48, 72, 96, 120, and Final Visit|Analysis is based on non-responder imputation (NRI), for which subjects with a missing value at a visit were imputed as a non-responder for that visit.||Subjects|||Number
117719|NCT00666965|Secondary|Clinical Global Impression (CGI) Severity|"CGI is a clinician-reported scale for assessing severity of illness.~The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients."|Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF||Percentage of Participants|||Number
117678|NCT00667355|Primary|Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.|Week 12|For all non-responder imputation (NRI) analyses, subjects with a missing value at a visit were imputed as a non-responder for that visit. Observed cases is based on a total of 40 subjects analyzed (vs. 41 subjects for the study and all other analysis sets) due to 1 subject who discontinued prior to Week 12.||Subjects|||Number
117679|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|||Weeks|Participants|Standard Deviation|Mean
117680|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain Medication|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.||Weeks|Participants|Full Range|Median
117681|NCT00667342|Other Pre-specified|Mean Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had surgery, experienced neuropathic pain and were treated with NP medication.||Weeks|Participants|Standard Deviation|Mean
117682|NCT00667342|Other Pre-specified|Median Duration of Neuropathic Pain|Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.|From surgery until resolution of NP symptoms, up to 6 months|All participants who met the criteria, had definitive surgery (either limb sparing or/and amputation), experienced neuropathic pain (NP) and were treated for NP until resolution of NP symptoms and off NP medications.||Weeks|Participants|Full Range|Median
117683|NCT00667342|Other Pre-specified|Number of Participants With Neuropathic Pain (NP) Following Surgery|Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively.|Up to 6 months postoperatively|||participants|Participants||Number
117684|NCT00667342|Secondary|2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 7 were expired and 24 still alive||probability||95% Confidence Interval|Number
117685|NCT00667342|Secondary|2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol.|The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.|After all patients have completed therapy, up to 2 years after last patient is enrolled|OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events.||probability||95% Confidence Interval|Number
117686|NCT00667342|Secondary|2-Year Overall Survival (OS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015.||probability||95% Confidence Interval|Number
117687|NCT00667342|Secondary|2-Year Event Free Survival (EFS) of Patients With Osteosarcoma|Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.|After all patients have completed therapy, up to 2 years after last patient is enrolled|All the 42 evaluable participants were included in this analysis.||probability||95% Confidence Interval|Number
117720|NCT00666965|Primary|Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score.~The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, end of maintenance period at 6 weeks|Full analysis set (FAS), last observation carried forward (LOCF)||scores on a scale||Standard Deviation|Mean
121743|NCT00627393|Secondary|Evaluation of Granulocyte Yield||Measured immediately after each granulocyte donation|||Granulocyte Yield (billion cells/liter)|Participants|Inter-Quartile Range|Median
117688|NCT00667342|Secondary|Histologic Response by Stratum|"The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133.~Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor).~The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done."|After 6 cycles of chemotherapy, up to 1 year after the start of therapy|All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.||participants|||Number
117689|NCT00667342|Primary|3-Year Event Free Survival Compared to Historical Controls on the Intergroup Study 0133|To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the event-free survival (EFS) in patients with localized resectable osteosarcoma compared to historical controls treated with cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133.|After all patients have completed therapy, up to 4 years after last patient is enrolled||||||
117690|NCT00667342|Primary|Number of Participants With Unacceptable Toxicity|"Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma.~The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications.~A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity."|After all patients have completed therapy, up to 1 year after last patient is enrolled|Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.||participants|||Number
117691|NCT00667277|Secondary|Number of Cycles|Number of cycles of bevacizumab received. Patients received bevacizumab as a single agent at a dose of 15 mg/kg intravenously on Day 1 of a 21-day cycle.|2 years|||cycles||Standard Deviation|Mean
117692|NCT00667277|Primary|Reason for Therapy Discontinuation|"Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab.~The two subjects who withdrew consent prior to initiation of therapy are included in the patient refusal category."|2 years|||participants|||Number
117693|NCT00667251|Secondary|Economic Evaluation, Including Health Utilities, as Measured by the EQ-5D Questionnaire, and Healthcare Utilization||Not available at this time||||||
117694|NCT00667251|Secondary|Effects of Changes in Biomarkers on Clinical Outcomes||Not available at this time||||||
117695|NCT00667251|Secondary|Quality of Life as Measured by the EORTC QLQ-C30 Global Score From Baseline to 12 Weeks|"The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life.~At 12 weeks: Group mean difference between arms"|12 weeks|||Score on global scale||Standard Deviation|Mean
117696|NCT00667251|Secondary|Clinical Benefit Response Rate (HER2/Neu+))|Best overall response of CR, PR, or stable disease at end of week 24.|24 weeks|||Participants|||Number
117697|NCT00667251|Secondary|Clinical Benefit Response Rate (ITT)|Best overall response of CR, PR or stable disease at end of week 24.|24 weeks|||Participants|||Number
117698|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) HER2/Neu+|Response determined by RECIST V 1.0|Median follow-up of 21.5 months.|||Participants|||Number
117699|NCT00667251|Secondary|Overall Objective Response Rate (Complete or Partial) ITT|"Patients included in this assessment must have had at least one measurable lesion at baseline, and had at least one RECIST re-evaluation after baseline while on protocol therapy, prior to, or on, date of progression.~Best overall response was classified to be Complete Response (CR) or Partial Response (PR)."|4 years|||Participants|||Number
117700|NCT00667251|Secondary|CNS Metastases at the Time of Progression (HER2+)||Incidence rate of CNS mestastes at first progression, assessed up to 39 months|151 patients with metastases assessed for CNS metastases; 128 patients with metastases assessed for CNS metastases.||CNS metastases|||Number
117701|NCT00667251|Secondary|CNS Metastases at the Time of Progression (ITT)||Incidence rate of CNS metastases at first progression assessed up to 39 months|178 Lapatinib patients with metastases assessed for CNS metastases; 157 Trastuzumab patients with metastases assessed for CNS metastases.||CNS metastases|||Number
117702|NCT00667251|Secondary|Time to CNS Metastases at the Time of First Progression||From randomization to CNS metastases at time of first progression, assessed up to 39 months.|||Months||Full Range|Median
117703|NCT00667251|Secondary|Overall Survival|OS median follow-up not achieved; estimated with quartile estimates|From randomization to death from any cause, assessed up to 44 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)||Months||Inter-Quartile Range|Median
117704|NCT00667251|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From randomization to RECIST V 1.0 progression or death assessed up to 39 months.|two subpopulations: ITT (n=652) and HER2+ (n=537)||Months||Full Range|Median
117705|NCT00667225|Secondary|Mean Change in Each Group Measured by Lesion Count.|Average change in number of lesions from baseline to 8 weeks|Baseline compared to 8 weeks (5 visits)|||lesions||Standard Deviation|Mean
117706|NCT00667225|Primary|Patients Experiencing Complete Clearance of All Molluscum Lesions.||Baseline compared to 8 weeks (5 visits)|We used a power calculation to estimate the number of patients needed to detect a clinically significant result.||Participants|Participants||Number
117707|NCT00667186|Secondary|Percentage Consenting to Testing|Percentage of those successfully offered testing who consent to testing|3 years|the number consenting to testing divided by the number offered testing||percentage of offered testing who consen|||Number
117709|NCT00667095|Secondary|Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||participants|||Number
117710|NCT00667095|Secondary|Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. this score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||participants|||Number
117711|NCT00667095|Secondary|Change in Urogenital Distress Inventory (UDI-6)|"The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
117712|NCT00667095|Secondary|Change in International Consultation on Incontinence Questionnaire – Short Form Score (ICIQ-SF)|The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life.|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the DSMO instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
117713|NCT00667095|Secondary|Change in Incontinence Impact Questionnaire Short Form (IIQ-7)|"The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from 0=Not at all to 3=Greatly. The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life."|baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DSMO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
117714|NCT00667095|Primary|Change in Incontinence Quality of Life (I-QoL) Score|"The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from ‘1= Extremely’ to ‘5= Not at all’.~A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a ‘Scale score’ ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items – lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life."|Baseline, 1 month, 3 months|Analysis was done according to the principle of intention-to-treat. The sample size was reduced to 9 in the Dimethyl Sulfoxide (DMSO) instillation arm at 3 months due to withdrawal for reasons unrelated to study (cancer).||units on a scale||Standard Deviation|Mean
117715|NCT00666965|Secondary|IRLS Each Parameter|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.~The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF||Percentage of Participants|||Number
117716|NCT00666965|Secondary|Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)|Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
117717|NCT00666965|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement.~The data at 6 weeks after dosing is shown."|Baseline, every two weeks|FAS, LOCF||Percentage of Participants|||Number
117718|NCT00666965|Secondary|Patient Global Impression (PGI) Improvement|The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7.|Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.|FAS, LOCF||Percentage of Participants|||Number
117745|NCT00666848|Primary|Change in MAP During Sitagliptin|Mean change in mean arterial pressure in response to placebo or enalapril in the presence of 5 days of sitagliptin 100mg/day|just prior to drug administration and 8 hours following treatment|||mmHg||Standard Deviation|Mean
117721|NCT00666926|Secondary|Caspase-3|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; sequential activation of caspases plays a central role in the execution-phase of cell apoptosis. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
117722|NCT00666926|Secondary|Phospho-SRC (pSRC)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; SRC proto-oncogenes are regulators of growth and differentiation of eukaryotic cells and are implicated in development of human tumors. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose; on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
117723|NCT00666926|Secondary|Phosphorylated Mitogen Activated Pathway Kinase (pMAPK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; MAPK regulates activities of several transcription factors. A defect in MAPK pathway leads to uncontrolled cell growth. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
117724|NCT00666926|Secondary|Phosphorylated Focal Adhesion Kinase (pFAK)|Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; FAK is overexpressed in a variety of human cancers. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.|Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)|Data was not summarized as samples were processed and analyzed later than 3 days after collection and thus the data were considered unusable.|||||
117725|NCT00666926|Secondary|Percentage of Participants With Best Overall Response as Measured Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment (Tx) until disease progression. Complete response: disappearance of all target lesions. Partial response: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD. Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions. Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Baseline up to 12 cycles (cycle=21days)|RECIST response analysis set: all enrolled participants who had an adequate baseline tumor assessment, measureable disease and who started treatment. N=number of participants with evaluable data at observation.||percentage of participants|||Number
117726|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): MDZ|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||mL/hr||Geometric Coefficient of Variation|Geometric Mean
117727|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): MDZ|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||hours||Standard Deviation|Mean
117728|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||hours||Full Range|Median
117729|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): MDZ|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
117730|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): MDZ|Area under the serum concentration time-curve from zero to the last measured concentration.|C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
117731|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): MDZ||C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose|N=participants in the PK parameter analysis set who received MDZ dosing prior to PF-00562271 in the 125 mg BID cohort; (n)=number of participants with analyzable data at observation.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
117732|NCT00666926|Secondary|Observed Accumulation Ratio (Rac): PF-00562271 C1.D14|Rac was the ratio of the Day 14 AUC0-tau (0 hour to last dose interval) and AUC during the corresponding time period after the lead-in dose (AUCtau C1.D14/AUCtau C0.D1).|Escalation (Esc) cohort: C0.D1: 0 hr, and 0.5, 1, 2, 4, 6, 7,12 hrs post dose; Expansion (Exp) cohort: C0:D1: 0 hr, and 1, 2, 4, 8 hrs post dose; Esc and Exp cohorts: C1.D14 0 hour, and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ratio||Geometric Coefficient of Variation|Geometric Mean
117733|NCT00666926|Secondary|Area Under the Curve From Time Zero to the End of the Dosing Interval (AUCtau): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
117734|NCT00666926|Secondary|Minimum Observed Serum Trough Concentration (Cmin): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
117735|NCT00666926|Secondary|Apparent Oral Clearance (CL/F): PF-00562271 C0. D1, C1.D1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
117736|NCT00666926|Secondary|Serum Decay Half-life (t 1/2): PF-00562271 C0.D1, C1.D1|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||hours||Standard Deviation|Mean
117737|NCT00666926|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): PF-00562271 C0.D1, C1.D1|AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
117738|NCT00666926|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-00562271 C0.D1, C1.D1|Area under the serum concentration time-curve from zero to the last measured concentration; nanograms multiplied by hours per milliliters (ng*hr/mL).|Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
117739|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||hours||Full Range|Median
117740|NCT00666926|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose|PK parameter analysis set. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||hours||Full Range|Median
117741|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C1.D14||Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose|PK parameter analysis set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
117742|NCT00666926|Secondary|Maximum Serum Concentration (Cmax): PF-00562271 C0.D1, C1.D1||Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 morning (am) dose|Pharmacokinetic (PK) parameter analysis set: all participants with at least 1 dose of study treatment and at least 1 of the PK parameters of interest estimated in at least 1 treatment period. Escalation cohorts: Cycle 0 48 hours post dose timepoint = C1.D1.||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
117743|NCT00666926|Primary|Percentage of Participants With Tumor Metabolic Response (Reduction of ≥15%) in Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|Metabolic response demonstrated in any tumor reduction of ≥15% in tumor FDG standardized uptake value (SUV) in Cycle 1; based on the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Participant must have had a baseline PET with at least 1 tumor lesion demonstrating an FDG SUV of ≥5.|Baseline, C1.D14|Participants in the 125 mg BID expansion cohort with at least 1 dose of study treatment, at least 1 lesion with an SUV ≥5 at baseline, and an on-study PET assessment C1.D14 (Day 13 up to Day 17).||percentage of participants||90% Confidence Interval|Number
117744|NCT00666926|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|At least possibly attributable to study treatment (Tx): Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or Gr 3 febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); Gr ≥3 non-hematologic toxicity despite adequate medical intervention; Gr ≥3 confirmed prolonged QTc interval (>500 milliseconds [msec]); confirmed cardiac troponin I ≥99 percentile of reference range; Tx related toxicities with failure to receive ≥18 days Tx in 21-day cycle or inability to resume current dose level ≤14 days.|Baseline up to Cycle 1 Day 21 (C1.D21)|Safety analysis set: All enrolled participants who started treatment.||participants|||Number
121772|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT||Mean Abstinent Days Per Week||Standard Error|Mean
117749|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint|"Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0–100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between score for self and score for average worker in same job. Mean change baseline to endpoint is reported."|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.||units on a scale||Standard Error|Least Squares Mean
117750|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint|Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0–100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.||hours lost per week||Standard Error|Least Squares Mean
117751|NCT00666757|Secondary|Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in diastolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371: and Week 12: Duloxetine N=274, SSRI N=285||mmHg||Standard Error|Least Squares Mean
117752|NCT00666757|Secondary|Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint|Mean change from baseline to endpoint in systolic blood pressure|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285||millimeters of mmercury (mmHg)||Standard Error|Least Squares Mean
117753|NCT00666757|Secondary|Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
117754|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=363, SSRI N=370; and Week 12: Duloxetine N=271, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
117755|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint|Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100–absenteeism] × [100–presenteeism]). Mean change baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Last Observation Carried Forward.||dollars||Standard Error|Least Squares Mean
117756|NCT00666757|Other Pre-specified|Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint|WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.|Baseline, 12 Weeks|Intent to Treat. Last Observation Carried Forward.||dollars||Standard Error|Least Squares Mean
117757|NCT00666757|Secondary|Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=260,SSRI N=267; and Week 12: Duloxetine N=182, SSRI N=192||units on a scale||Standard Error|Least Squares Mean
117758|NCT00666757|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)|The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
117809|NCT00666562|Secondary|Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
117759|NCT00666757|Secondary|Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=346, SSRI N=348; and Week 12: Duloxetine N=249, SSRI N=257||units on a scale||Standard Error|Least Squares Mean
117760|NCT00666757|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)|The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=211, SSRI N=233; and Week 12: Duloxetine N=156, N=166||units on a scale||Standard Error|Least Squares Mean
117761|NCT00666757|Secondary|Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285||units on a scale||Standard Error|Least Squares Mean
117762|NCT00666757|Secondary|Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
117763|NCT00666757|Secondary|Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284||units on a scale||Standard Error|Least Squares Mean
117764|NCT00666757|Secondary|Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)|"HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the core symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe)."|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
117765|NCT00666757|Secondary|Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)|HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint.|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
117766|NCT00666757|Secondary|Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)|The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).|Baseline, 12 Weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283||units on a scale||Standard Error|Least Squares Mean
117767|NCT00666757|Secondary|Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283||Probability of response||Standard Error|Least Squares Mean
117768|NCT00666757|Secondary|Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]|Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.|Baseline, 12-Weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||Probability of response||Standard Error|Least Squares Mean
117769|NCT00666757|Secondary|Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]|Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.|12 weeks|Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283||Probability of remission||Standard Error|Least Squares Mean
117770|NCT00666757|Secondary|Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)|The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.|Baseline, 12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||units on a scale||Standard Error|Least Squares Mean
117771|NCT00666757|Primary|Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]|Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.|12 weeks|Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284||Probability of remission||Standard Error|Least Squares Mean
117772|NCT00666718|Secondary|Number of Injections of Insulin at Week 24||Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Participants|||Number
117773|NCT00666718|Secondary|Total Daily Insulin Dose at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Units||Standard Error|Least Squares Mean
117774|NCT00666718|Secondary|Change in Body Weight From Baseline to Week 24|LSMean values presented were controlled for treatment, country, and baseline HbA1C value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.||Kilograms (kg)||Standard Error|Least Squares Mean
117775|NCT00666718|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is located in the Reported Adverse Event module.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.||participants|||Number
117776|NCT00666718|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes|Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.||percentage of participants|||Number
117777|NCT00666718|Secondary|Rate Of All Self-reported Hypoglycemic Episodes|Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Baseline through Week 24|Safety population - all participants who received at least one dose of study drug.||episode/30 days/participant||Standard Error|Least Squares Mean
117778|NCT00666718|Secondary|Glycemic Variability at Endpoint|LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.|Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||mmol/L||Standard Error|Least Squares Mean
117779|NCT00666718|Secondary|7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint|LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.|24 weeks|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
117780|NCT00666718|Secondary|Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint||Week 24|Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Percent of Participants|||Number
117781|NCT00666718|Secondary|Change From Baseline in HbA1c at Week 12 and Week 24|LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.|Baseline, Week 12, Week 24|Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||Percent of Glycosylated Hemoglobin||95% Confidence Interval|Least Squares Mean
117810|NCT00666562|Secondary|Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples||up to 28 days|Analysis was not able to be completed for 2 participants in Arm I and 2 participants in Arm III.||ng/mL||Standard Deviation|Mean
117782|NCT00666718|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24|Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.|Baseline, Week 24|Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.||Percent of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
117783|NCT00666705|Other Pre-specified|Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
117784|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
117785|NCT00666705|Other Pre-specified|Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
117786|NCT00666705|Primary|Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).|Days 3 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng.hr/mL||Standard Deviation|Mean
117787|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng/mL||Standard Deviation|Mean
117788|NCT00666705|Primary|Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)|Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).|Days 11 and 14|The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.||ng.hr/mL||Standard Deviation|Mean
117789|NCT00666679|Post-Hoc|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period in patients who met lung function eligibility criteria at randomization; measurements taken at 1 and 2 weeks contributed to average.|Baseline and 2 Weeks|The analysis was based on a subset of the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug, had a measurement for analysis available in at least one treatment period and met lung function eligibility criteria specifically at the randomization visit.||L (Liter)||95% Confidence Interval|Least Squares Mean
117790|NCT00666679|Other Pre-specified|Change From Baseline in Total Peripheral Blood Eosinophils|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||10^3/microliter||95% Confidence Interval|Least Squares Mean
117791|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Exacerbations|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period.|2 Weeks|The analysis was based on the Completers Set population which included all randomized patients who took a dose of blinded post randomization study drug (inhaled montelukast or matching placebo) in both treatment periods and had a measurement for analysis available in both treatment periods of the cross-over design.||Percentage of Days||95% Confidence Interval|Least Squares Mean
117811|NCT00666562|Secondary|Serum IGFBP-3 Levels Assessed by ELISA||Baseline and up to 28 days|Analysis was not able to be completed for 2 participants in Arm I.||ng/mL||Standard Deviation|Mean
117812|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)||At Baseline|"This outcome was assessed in all participants,combined irrespective of their randomization.~Analysis was not able to be completed on 4 participants."||ng/mL||Standard Deviation|Mean
117792|NCT00666679|Other Pre-specified|Percentage of Days With Asthma Control|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||Percentage of Days||95% Confidence Interval|Least Squares Mean
117793|NCT00666679|Other Pre-specified|Change From Baseline in Total Daily β-agonist Use|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||Puffs||95% Confidence Interval|Least Squares Mean
117794|NCT00666679|Secondary|Change From Baseline in Nighttime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on a subset of the FAS population which included all randomized patients with nighttime symptoms at baseline (score>0), who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period.||Units on a Scale||95% Confidence Interval|Least Squares Mean
117795|NCT00666679|Secondary|Change From Baseline in Daytime Asthma Symptom Score|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||Units on a Scale||95% Confidence Interval|Least Squares Mean
117796|NCT00666679|Primary|Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)|To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.|Baseline and 2 weeks|The analysis was based on the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.||L (Liter)||95% Confidence Interval|Least Squares Mean
117797|NCT00666666|Secondary|Percentage of Patients With Overall PSA < 4.0 ng/mL||3 years|||percentage of participants|||Number
117798|NCT00666666|Secondary|Percentage of Patients With PSA ≥ 0.2 ng/mL But < 4.0 ng/mL||3 years|||percentage of participants|||Number
117799|NCT00666666|Primary|Percentage of Patients With Undetectable Prostate-specific Antigen (PSA) (< 0.2 ng/mL) at End of 7 Cycles||3 years|||percentage of participants|||Number
117800|NCT00666588|Secondary|Feasibility of Stem Cell Quantitation|Descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. nonresponders, stem cell percentage differences between responders and nonresponders will be compared using a paired t-test or equivalent nonparametric test.|At baseline and after completion of course 1||||||
117801|NCT00666588|Secondary|Protein Expression Assessed by Western Blot|Relative expression of apoptotic and cell cycle proteins will be characterized using descriptive statistics. If differences are noted between pre and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test if the data are non-normally distributed. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|At baseline, prior to and up to 24 hours after bortezomib treatment||||||
117802|NCT00666588|Secondary|Proteasome Inhibition Activity|Descriptive statistics will be used to determine the mean and standard deviation of proteasome inhibition.|At baseline, 2 hours prior to and 3 hours after first bortezomib dose||||||
117803|NCT00666588|Secondary|NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)|NF-kB activity will be measured as a continuous variable (ng NF-kB/Mg protein). Differences in NF-κB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. We may perform exploratory analyses to determine if single time point measurements, or the difference between time points, correlate with treatment response.|At baseline, prior to and up to 24 hours after bortezomib treatment||||||
117804|NCT00666588|Primary|Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1|Overall response (complete remission [CR] and CR with partial recovery [CRp]) during course 1.|After course 1|||participants|||Number
117805|NCT00666588|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity.|During Course 1|||participants|||Number
117806|NCT00666562|Secondary|Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)||At Baseline|This outcome was assessed in all participants,combined irrespective of their randomization. Analysis was not able to be completed for 4 participants.||ng/mL||Standard Deviation|Mean
117807|NCT00666562|Secondary|Absolute Change for Baseline of EGCG in Urine Samples|The difference between the amount at the end of study (up to 28 days) from baseline.|Baseline and up to 28 days|Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.||ng/mL||Standard Deviation|Mean
120602|NCT00638235|Secondary|Procedural Time|Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes|Approximately 30 minutes|||minutes||Standard Deviation|Mean
117818|NCT00666562|Primary|Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)|Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.|up to 28 days|||ng/mL||Standard Error|Mean
117819|NCT00666536|Secondary|Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||Percentage of Patients|||Number
117820|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSDBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
117821|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSSBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
117822|NCT00666536|Secondary|Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
117823|NCT00666536|Secondary|Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)||Percentage of Patients|||Number
117824|NCT00666536|Primary|Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)||mmHg||Standard Deviation|Mean
117825|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.||mmol/L||Standard Error|Mean
117826|NCT00666458|Secondary|Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)|Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.|Baseline, Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.||mg/dL||Standard Error|Mean
117827|NCT00666458|Secondary|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18|Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)|Week 18 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement.||Percentage of Participants|||Number
117828|NCT00666458|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 18|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline, Week 18|Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations.||Percent||Standard Error|Mean
117829|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
117830|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted CL * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
117831|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed as weight-adjusted Clearance (CL) * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
117832|NCT00666406|Secondary|Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed as weight-adjusted Clearance * Mean Residence Time|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/kg||90% Confidence Interval|Geometric Mean
117833|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117834|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117835|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117836|NCT00666406|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117837|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117838|NCT00666406|Secondary|Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117839|NCT00666406|Secondary|Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117840|NCT00666406|Secondary|Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||Hours||90% Confidence Interval|Geometric Mean
117841|NCT00666406|Secondary|Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
117842|NCT00666406|Secondary|Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Increase in factor VIII concentration from pre- to post-infusion|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
117843|NCT00666406|Secondary|Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
117844|NCT00666406|Secondary|Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Increase in factor VIII concentration from pre- to post-infusion.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||(IU/dL)/(IU/kg)||90% Confidence Interval|Geometric Mean
117845|NCT00666406|Secondary|Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
117846|NCT00666406|Secondary|Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
117847|NCT00666406|Secondary|Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
117848|NCT00666406|Secondary|Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations (9 to 48 hours).|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||hours||90% Confidence Interval|Geometric Mean
117849|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
117850|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
117851|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
117852|NCT00666406|Secondary|Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU/dL||90% Confidence Interval|Geometric Mean
117853|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
117854|NCT00666406|Secondary|Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
121773|NCT00626925|Secondary|Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype||12 weeks|ITT||Mean Heavy Drinking Days Per Week||Standard Error|Mean
117855|NCT00666406|Secondary|Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
117856|NCT00666406|Secondary|Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||mL/h/kg||90% Confidence Interval|Geometric Mean
117857|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117858|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117859|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117860|NCT00666406|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)|"AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.~FVIII activity measurement"|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117861|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117862|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117863|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117864|NCT00666406|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. One-Stage Activated Partial Thromboplastin Time (aPTT) -Based Assay Performed at Central Laboratory (Medical University Vienna)|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|0-30 minutes before infusion up to 48 hours post-infusion|All enrolled participants||IU*h/dL||90% Confidence Interval|Geometric Mean
117865|NCT00666328|Secondary|The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion||Within 30 minutes of the initiation of study drug infusion|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.||percent participants|||Number
117866|NCT00666328|Secondary|Percent Change in Heart Rate During 30 of Initiation of Clevidipine|Multiple timepoints were assessed (minutes 1, 2, 3, 4, 5, 10, 15, 20, 30) for analysis of percent change in heart rate during the initial 30 minutes.|From study drug initiation through each specified timepoint|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. Data for 33 of the 35 patients in the Safety population had data for the 30 minute time point used for this analysis.||percent change||Standard Deviation|Mean
117867|NCT00666328|Secondary|Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine|Additional or alternative antihypertensive agent(s) comprise the use of other antihypertensive agent(s) either with clevidipine (additional) or in place of clevidipine (alternative) for the indication of hypertension from the time of clevidipine initiation to clevidipine termination. For purposes of this analysis, additional or alternative antihypertensive agents did not include oral antihypertensives that were administered in order to transition IV clevidipine-treated patients to oral therapy during the transition period of the study.|Up to 96 hours|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.||participants|||Number
117868|NCT00666328|Secondary|Median Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours|||milligrams (mg)||Inter-Quartile Range|Median
117869|NCT00666328|Secondary|Mean Dose of Clevidipine During the Treatment Period|Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment|Up to 96 hours|The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses.||milligrams (mg)||Standard Deviation|Mean
121774|NCT00626925|Secondary|Mean Daily Alcohol Consumption||12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment||||||
117870|NCT00666328|Secondary|Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine|The percent time that SBP was maintained within the SBP target range (≤160 mmHg to ≥140 mmHg) was summarized for each 24-hour period of monotherapy of clevidipine infusion through 96 hours (0 -≤24 h, 24-≤48 h, 48-≤72 h, 72-≤96 h). For purposes of this analysis, SBP data were available from all mITT patients for the overall infusion period and from 0 to ≤24 hours of infusion; however, data was only available for 8 patients from 24 to ≤48 hours, 4 patients from 48 to ≤72 hours and 1 patient from 72 to ≤96 hours due to the variability in infusion durations >24 hours across patients.|From study drug initiation through termination (up to 96 h)|The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses.||percent time||Standard Deviation|Mean
117871|NCT00666328|Secondary|Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion|Total AUC-SBP captures the magnitude and duration of SBP either above the upper limit of the target SBP range at 160 mm Hg or below the lower limit of 140 mm Hg and normalized per hour for the duration of clevidipine infusion. A larger value for AUC-SBP indicates greater SBP variability outside the target range.|Duration of the study drug infusion (up to 96 hours)|||mm Hg × min/hr||Standard Deviation|Mean
117872|NCT00666328|Secondary|Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion|Over the initial 30 minutes of the treatment period, the percent change from baseline (defined as immediately prior to study drug initiation) was summarized descriptively at 1, 2, 3, 4, 5, 6, 7, 10, 15, 20, 25, and 30 minutes after clevidipine initiation. Decreases in SBP from baseline were observed over the course of this time period.|Baseline through 30 minutes post initiation of clevidipine infusion|||percent change in SBP||Standard Deviation|Mean
117873|NCT00666328|Secondary|Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine|The percentage of patients who reached SBP of ≤160 mmHg within the first 30 minutes of initiation of clevidipine infusion was summarized. If an additional or alternative IV antihypertensive agent and/or oral antihypertensive agent was administered for hypertension prior to a patient achieving SBP≤160 mmHg during the initial 30-minute treatment period, then the patient was considered to have failed to reach this efficacy endpoint.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.||percent participants||95% Confidence Interval|Number
117874|NCT00666328|Primary|Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine|The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given.|Within 30 minutes of study drug initiation|Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met.||minutes||95% Confidence Interval|Median
117875|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.|Number of participants with or without Non-drug therapies with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117876|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.|Number of participants with or without Concomitant drugs with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117877|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Weight.|Number of participants Weight as over 40kg or less than 40kg with adverse drug reaction to determine whether over 40kg or less than 40kg Weight is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117878|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Route of Administration.|Number of participants Route of administration as by oral,injection or oral from injection with adverse drug reaction to determine whether oral, injection or switch is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117879|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.|Number of participants with Duration of drug administration as over 15 days or less than 15 days with adverse drug reaction to determine whether over 15 days or less than 15 days is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117880|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.|Number of participants with or without Renal dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117881|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.|Number of participants with or without Hepatic dysfunctions with adverse drug reaction to determine whether with or without is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117882|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Age|Number of participants with adverse drug reaction to determine whether over 65 or less than 65 is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117883|NCT00666276|Primary|Factors Considered to Affect the Safety of Linezolid - Gender.|Number of participants with adverse drug reaction to determine whether male or female is significant risk factor.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117884|NCT00666276|Primary|Number of Participants With Adverse Drug Reactions(ADRs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Adverse Drug Reactions were evaluated in company with the causal relationship to the investigational product.|8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117885|NCT00666276|Primary|Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.|The adverse drug reaction that have not been listed in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consists of the participants that satisfy the inclusion and exclusion conditions and in whom administration of this drug was confirmed.||participants|||Number
117886|NCT00666263|Primary|The Percentage of Participants Reporting One or More Moderate or Severe AEs That Began During Infusion or Within 72 Hours of Completion of an Infusion||Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||percentage of participants|||Number
117887|NCT00666263|Secondary|The Proportion of Infusions Associated With One or More AEs Related to the Study Product||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||proportion of infusions|Participants||Number
117888|NCT00666263|Secondary|The Proportion of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||proportion of infusions|Participants||Number
117889|NCT00666263|Secondary|The Proportion of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Tolerability Concerns/AEs||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||proportion of participants|||Number
117890|NCT00666263|Secondary|Rate of Related SAEs Per Infusion|The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||SAEs per infusion|Participants||Number
117891|NCT00666263|Secondary|Rate of Related AEs Per Infusion|The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100.|Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||AEs per infusion|Participants||Number
117892|NCT00666263|Primary|The Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||percentage of infusions|Participants||Number
117893|NCT00666263|Primary|The Percentage of Participants for Whom the Infusion Rate of Any Infusion Was Reduced and/or the Infusion Was Interrupted or Stopped for Any Reason||Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||percentage of participants|||Number
117894|NCT00666263|Primary|Rate of Temporally Associated Adverse Events (AEs) Per Infusion|The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100.|Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Safety Dataset||Percentage of AEs per infusion|Participants||Number
117895|NCT00666263|Primary|Co-Primary Endpoint: Proportion of Participants With Deterioration in Guy’s Neurological Disability Score (GNDS)|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Proportion of participants|||Number
117896|NCT00666263|Post-Hoc|Proportion of Participants With at Least a 30% Decline in Relative Grip Strength in the Less Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Proportion of participants|||Number
117897|NCT00666263|Primary|Co-Primary Endpoint: Guy's Neurologic Disability Scale (GNDS) for Upper Limbs|GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
117976|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 4 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 4 months of treatment|4 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117898|NCT00666263|Secondary|Mean Relative Change in Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in assessment||95% Confidence Interval|Mean
117899|NCT00666263|Secondary|Participants' Assessment of Physical Functioning on a Visual Analog Scale (VAS)|The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
117900|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in time||95% Confidence Interval|Mean
117901|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their non-dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Seconds||Inter-Quartile Range|Median
117902|NCT00666263|Secondary|Mean Relative Change in Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in time||95% Confidence Interval|Mean
117903|NCT00666263|Secondary|Time Required by Participants to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Participants picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, participants removed the pegs one at a time and returned them to the container as quickly as possible. Each participant did this two times with their dominant hand. The 9-HCT objective is to see how fast participants could put all of the pegs in and take them out again.|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Seconds||Inter-Quartile Range|Median
117904|NCT00666263|Secondary|Mean Relative Change in Overall Disability Sum Score|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, “no signs of disability” to 12, “most severe disability”). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||percent change in score||95% Confidence Interval|Mean
117905|NCT00666263|Secondary|Overall Disability Sum Score - Standardized|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability).~This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
117906|NCT00666263|Secondary|Overall Disability Sum Score|"The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability.~Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability)."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
118805|NCT00659789|Secondary|Effect of Vacc-4x on CD8 Counts|CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52|Weeks 6,18,24,28,32,36,40,44,48,52.|Subject who stopped ART at week 28 and remained off ART until week 52||cells/µL||Inter-Quartile Range|Median
117907|NCT00666263|Secondary|Patient Global Impression of Change|"Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)).~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||Scores on a scale||Inter-Quartile Range|Median
117908|NCT00666263|Secondary|Proportion of Participants That Were Accelerated Forward Into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)|Participants were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the participant had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred.|During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)|Intent to treat||Proportion of participants|||Number
117909|NCT00666263|Secondary|Mean Relative Change in Grip Strength in the Less Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in grip strength||95% Confidence Interval|Mean
117910|NCT00666263|Secondary|Grip Strength in the Less Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.~Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||kilograms||Inter-Quartile Range|Median
117911|NCT00666263|Secondary|Percentage of Participants With at Least a 30% Decline in Relative Grip Strength in the More Affected Hand (Measured Using a DynEx Digital Dynamometer)|"Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percentage of participants|||Number
117912|NCT00666263|Primary|Mean Relative Change in Grip Strength in the More Affected Hand|"Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period.~The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing."|Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)|Intent to treat||Percent change in grip strength||95% Confidence Interval|Mean
117913|NCT00666263|Primary|Grip Strength in the More Affected Hand|"The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg.~Each grip strength test consisted of 3 maximal repeated contractions (trials). Each participant will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand."|Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit|Intent to treat||kilograms||Inter-Quartile Range|Median
117914|NCT00666224|Secondary|Percentage of Participants Who Converted to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set.||percentage of total participants|||Number
117915|NCT00666224|Primary|Twenty-fifth Percentile (25%) Kaplan-Meier Estimates for Time From Randomization to Conversion to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. Due to the number of participants in the glatiramer acetate group that converted to CDMS (see outcome #6), the 25th percentile was considered when running the Kaplan-Meier estimate for time to conversion to CDMS. Conversion to CDMS is determined by the occurrence of the second clinical attack.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.||days||95% Confidence Interval|Number
117948|NCT00665925|Secondary|Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months|Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117916|NCT00666224|Secondary|Percentage Change in Brain Volume From Baseline to the Last Observed Value (LOV) During the Double-blind Period Using the Structural Image Evaluation of Normalized Atrophy (SIENA) Technique|Data from interim analysis with database lock on October 14, 2007. Brain volume was measured annually by magnetic resonance imaging (MRI) during the Double-blind period. Brain atrophy was measured by comparing the change in brain volume from baseline to the Last Observed Value (LOV). LOV is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation. SIENA is a fully automated method of analyzing longitudinal brain change.|Day 0 (baseline), up to 3 years|Intent to treat population of participants with both baseline and last observed values.||percent change||Standard Deviation|Mean
117917|NCT00666224|Secondary|Change From Baseline to Last Observed Value (LOV) in T2 Brain Lesion Volume in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. The difference in T2 brain lesion volume as observed in MRIs from baseline to the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|Day 0 (baseline), up to 3 years|Intent to treat population for which data at both timepoints are available||ml||Standard Deviation|Mean
117918|NCT00666224|Secondary|Number of New T2 Brain Lesions Observed at the Last Observed Value (LOV) in the Double-blind Period|Data from interim analysis with database lock on October 14, 2007. T2 lesions are brain lesions that show on magnetic resonance imaging (MRI) and are associated with multiple sclerosis. This outcome measures the number of new lesions at the last observed value. Last Observed Value (LOV) is defined as the last post baseline measurement taken on study drug but no more than 30 days after study drug cessation.|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.||new T2 lesions||Standard Deviation|Mean
117919|NCT00666224|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion|Data from interim analysis with database lock on October 14, 2007. The time from randomization to conversion to CDMS as determined by the occurrence of a second clinical attack during the double-blind period. Poser criteria are: Two relapses and clinical evidence of two separate lesions; clinical evidence of one lesion and paraclinical evidence of another separate lesion. The two relapses must involve different parts of Central Nervous System and must be separated by a period of at least one month. Lesions are determined by Magnetic Resonance Imaging (MRI).|up to 3 years|Intent-to-Treat (ITT) analysis set. The ITT consists of all participants who have been randomized and received at least one dose of glatiramer acetate or placebo.||days||Standard Deviation|Mean
117920|NCT00666211|Primary|Pain Duration|Pain duration in hours 0 to 24|at 9 weeks|||hours||Standard Deviation|Mean
117921|NCT00666211|Primary|Pain-related Distress|Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8. Pain-related distress scale is from 0 (no pain) to 10 (worst pain).|Baseline(Week 0) to week 8, Total time frame is 9 weeks.|||units on a scale||Standard Deviation|Mean
117922|NCT00666211|Secondary|Quality of Life|Each patient in each arm is scored on the Functional Assessment of Cancer Therapy-General (FACT-G) at baseline + week 8 with 4 related sub-scales (physical, social/family, emotional, functional well-being. To generate sub-scale scores, physical and emotional items are reverse coded & items are then summed, such that higher values indicate better quality of life. Thus, each sub-scale score ranges from 0 (not at all, worse outcome) to 4 (very much, better outcome) with a minimum total score of 0 (worst quality of life) to a maximum of 16 (good quality of life).|9 weeks|||scores on a scale||Standard Deviation|Mean
117923|NCT00666211|Secondary|Mood Disturbance|Patients in each arm will each have 5 measures on the Profile of Mood States-Short Form (POMS-SF): baseline + weeks 2, 4, 6, 8. The POMS-SF consists of 37 questions, querying 6 mood states (anxiety, depression, anger, confusion, fatigue, and vigor), with responses on a scale from 0 (not at all) to 4 (extremely). To generate a summary score, questions on vigor state are first recoded to reverse the scale, so that higher summary scores consistently indicate greater mood disturbance.|9 weeks|||units on a scale||Standard Deviation|Mean
117924|NCT00666211|Secondary|Interference in Daily Life Due to Pain|Patients in each arm will each have 5 measures on the Brief Pain Inventory (BPI) scale: baseline + weeks 2, 4, 6, 8. The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average from the 7 questions, with higher score indicating greater interference due to pain.|9 weeks|||units on a scale||Standard Deviation|Mean
117925|NCT00666211|Secondary|Ability to Engage in Activities of Daily Living (ADL)|The Functional Assessment Screening Questionnaire (FASQ) scale is used, scored at baseline and at weeks 2, 4, 6, 8. The FASQ consists of 15 questions about ability to perform ADL with minimum score of 1 (easy to perform) to a maximum score of 5 (N/A, meaning someone else performs this activity for the patient or else the patient chooses not to do it). A summary mean score is generated with a minimum score of 1 and a maximum score of 5.|Baseline(Week 0) to week 8, Total time frame is 9 weeks.|||units on a scale||Standard Deviation|Mean
117926|NCT00666211|Primary|Pain Intensity|"Patients in each arm will each have 9 measures: daily scores averaged over 1 week with baseline to week 8:~Average daily pain intensity 0 (no pain) to 10 (worst) scale~Worst daily pain intensity 0 (no pain) to 10 (worst) scale"|Baseline(Week 0) to week 8, Total time frame is 9 weeks.|||units on a scale||Standard Deviation|Mean
117927|NCT00666029|Primary|Insulin Sensitivity Index|Insulin sensitivity index was assessed during the final steady state 30 minutes of a high dose hyperinsulinaemic euglycaemic clamp (insulin infusion rate 1.5 mIU/kg/min). During this part of the clamp, insulin was infused at 1.5mIU/kg/min and the glucose concentration was maintained at 5 mmol/L using a dextrose infusion. The whole body insulin mediated glucose disposal rate (M value - mg/kg/min) was estimated from the total amount of glucose infused during the last 30 minutes of the clamp. The mean of four serum insulin concentrations was taken during this 30 minutes to determine the steady state insulin concentration (I value - milliunits/litre). M value/I value defined the insulin sensitivity index.|6 months|There was missing data in four people in the atorvastatin arm and two people in the placebo arm||mg*kg^-1*min^-1*mIU^-1*L^-1||Standard Deviation|Mean
117974|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 months of treatment|6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117928|NCT00666029|Primary|Muscle Microvascular Function|Skeletal muscle microvascular function assessed (Filtrass plethysmographic system) using a passive inductive transducer (Compumedics.dwl, Singen, Germany) and a small pressure step venous congestion protocol. Fluid filtration rate (Jv mL min-1 100 mL-1), measured from the slope of limb volume change in response to each pressure step (10 mmHg steps to 60 mmHg around the thigh) over the last 2 minutes of its application, to allow for completion of vascular filling, and plotted against cuff pressure (Pcuff). The slope of this relationship, at pressures above those giving rise to net filtration, is a measure of Kf, microvascular filtration capacity, a function of exchange surface area and permeability. The CV for Kf measurement was 14.5%.|6 months|There was missing data on two participants in the atorvastatin arm and two participants in the placebo arm.||10^3 mL*min^-1*100ml^-1*mmHg^-1||Standard Deviation|Mean
117929|NCT00665925|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC (a test of liver function) values lower than 1500/mm3|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117930|NCT00665925|Secondary|Bilirubin >2 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117931|NCT00665925|Secondary|Bilirubin >1.5 x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117932|NCT00665925|Secondary|Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117933|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117934|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117935|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117936|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117937|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117938|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5-2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117939|NCT00665925|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117940|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117941|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117942|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117943|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117944|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117945|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117946|NCT00665925|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117947|NCT00665925|Secondary|Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months|Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment|Baseline to 6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117949|NCT00665925|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months|Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.|Baseline to 6 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117950|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117951|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117952|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117953|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117954|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117955|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117956|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117957|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117958|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117959|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117960|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117975|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 5 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 5 months of treatment|5 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
121775|NCT00626925|Secondary|Mean Abstinent Days Per Week by Medication Group||12 weeks|Intention to treat (ITT).||Mean abstinent days per week||Standard Error|Mean
117961|NCT00665925|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with ESR as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117962|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117963|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117964|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117965|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117966|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117967|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117968|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|6 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117969|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|5 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117970|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|4 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117971|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117972|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|2 months|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117973|NCT00665925|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|1 month|Intent-to-Treat Population with CRP as Primary Phase Reactant with available data and received study drug.||Participants|||Number
117977|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117978|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 months of treatment|2 months|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117979|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 6 weeks of treatment|6 weeks|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117980|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Month|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 month of treatment|1 month|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117981|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 2 weeks of treatment|2 weeks|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117982|NCT00665925|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 1 Week|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 1 week of treatment|1 week|Intent-to-treat population with available data and received study drug.||Score||Standard Deviation|Mean
117983|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117984|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 5 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117985|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 4 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117986|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117987|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117988|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 6 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
117989|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Month|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.||Participants|||Number
117990|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 2 Weeks|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
117991|NCT00665925|Secondary|American College of Rheumatology 70 (ACR70) Response at 1 Week|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.||Participants|||Number
118142|NCT00664326|Secondary|Overall Survival|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
117992|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117993|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 5 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117994|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 4 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117995|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117996|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
117997|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 6 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
117998|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Month|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.||Participants|||Number
117999|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 2 Weeks|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
118000|NCT00665925|Secondary|American College of Rheumatology 50 (ACR50) Response at 1 Week|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.||Participants|||Number
118001|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 5 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months|5 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
118002|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 4 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months|4 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
118003|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months|3 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
118004|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months|2 months|Intent-to-treat population with available data and received study drug.||Participants|||Number
118005|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 6 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks|6 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
118006|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Month|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month|1 month|Intent-to-treat population with available data and received study drug.||Participants|||Number
118007|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 2 Weeks|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks|2 weeks|Intent-to-treat population with available data and received study drug.||Participants|||Number
118008|NCT00665925|Secondary|American College of Rheumatology 20 (ACR20) Response at 1 Week|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week|1 week|Intent-to-treat population with available data and received study drug.||Participants|||Number
118009|NCT00665925|Primary|American College of Rheumatology 20 (ACR20) Response at 6 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months|6 months|Intent-to-treat population includes all subjects that received study drug||Participants|||Number
118010|NCT00665847|Secondary|The Emergence of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations (NNRTI RAMs) in Patients Classified as Virologic Failures|Virologic failure (lack of response) was defined as: plasma viral load decline of < 0.5 log10 from Baseline by Week 8 and/or plasma viral load decline of <1.0 log10 from Baseline by Week 12. Virologic failure (loss of response) was defined as 2 consecutive measurements of plasma viral load > 0.5 log10 above the nadir after a minimum of 12 weeks of treatment. The table below provides data for 41 viologic failures of which 30 had mutation data available. In the table below, only the 4 most frequently emerging mutations are presented (emerging in at least 3 patients).|Baseline and Endpoint (up to Week 48)|The patients in the intent-to-treat (ITT) population classified as virologic failures were used for this analysis.||Patients|||Number
118011|NCT00665847|Secondary|The Change From Baseline in CD4 Cell Counts Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||10E6 cells/L||Standard Error|Mean
118012|NCT00665847|Secondary|Change From Baseline in Human Immunodeficiency Virus – Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time||Baseline, Week 48|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||log10 copies/mL||Standard Error|Mean
118013|NCT00665847|Secondary|Percentage of Patients With Virologic Response at Week 24|Virologic response was defined as the percentage of patients with plasma viral load < 50 copies/mL at Week 24 calculated according to the non-completer=failure (NC=F) imputation method.|Week 24|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||Percentage of Patients|||Number
118014|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax)|Etravirine/TMC125 (ETR) Cmax was approximated for each individual using the median value of plasma ETR concentrations taken 4 hours postdose (± 1 hour), when available, on the day of the Week 4 visit as shown in the table below.|Week 4|The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken Etravirine/TMC125 (ETR) at least once, regardless of their compliance with the protocol was used for this analysis.||ng/mL||Standard Deviation|Mean
118015|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h)||Week 48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."||ng/mL||Standard Deviation|Mean
118016|NCT00665847|Secondary|Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h)|The AUC12h is a Bayesian estimation based on a population pharmacokinetic model and sparse samples collected at each visit over the duration of trial. For each sparse sample taken, the time blood sample was recorded as well as the time of etravirine intake just prior to the time of blood sample.|Weeks 4-48|"The intent-to-treat (ITT) population, i.e. all patients who had been enrolled and taken ETR at least once, regardless of their compliance with the protocol was used for this analysis. The table below shows results for Overall (children and adolescents combined)."||ng.h/mL||Standard Deviation|Mean
118017|NCT00665847|Primary|The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs)|The percentage of patients with a treatment-emergent adverse event (TEAE) (defined as an event that occurred in the 48-week treatment period during which it emerged [i.e. started or worsened in severity, relation, or other attribute], and not in the subsequent study periods, even if the event continued to be present] are provided below. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.||Percentage of patients|||Number
118040|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months|Change from baseline in RAMRIS osteitis score (a measure of bone inflammation in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The osteitis score runs from 0 to 75 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population||Score||Standard Deviation|Mean
118018|NCT00665847|Primary|The Number of Patients With Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event continued to be present. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen|48 weeks|The safety analysis was done on the intent-to-treat (ITT) population, which included all patients who received at least one dose of investigational medication.||Patients|||Number
118019|NCT00665704|Secondary|Patient Feedback to Evaluate the Website|Formative evaluation during pre-testing included qualitative feedback on the: 1) ability to accomplish tasks; 2) ability to accomplish goals with skill and speed; 3) ability to operate the system; and 4) satisfaction. For the 9 veteran smokers that actually tried to use the Tobacco Tactics website to quit smoking, we were able to determine: 1) the number of times they signed onto the website; 2) the time spent on the website; and 3) the number of times each module was accessed.|30 days post intervention|||participants|||Number
118020|NCT00665704|Primary|Self Reported 30 Day Smoking Quit Rate|Impact evaluation was the 30-day quit rates of the 9 veteran smokers that agreed to use the website.|30 days post intervention|||participants|||Number
118021|NCT00665626|Secondary|Absolute Neutrophil Count (ANC) <1500/mm3|The number of participants with ANC values less than 1500/mm3|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118022|NCT00665626|Secondary|Bilirubin >2x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118023|NCT00665626|Secondary|Bilirubin >1.5x Upper Limit of Normal (ULN)|The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118024|NCT00665626|Secondary|Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline|The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118025|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118026|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118027|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118028|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118029|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118030|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118031|NCT00665626|Secondary|Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)|The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118032|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118033|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118034|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118035|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118036|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118037|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118038|NCT00665626|Secondary|Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)|The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN|Any time between baseline and 3 months|Intent-to-treat population||Participants|||Number
118039|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months|Change from baseline in RAMRIS synovitis score (a measure of inflammation in the joints of the hands and wrists), calculated as the score at 3 months minus the score at baseline. The synovitis score runs from 0 to 24 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population||Score||Standard Deviation|Mean
118041|NCT00665626|Secondary|Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months|Change from baseline in RAMRIS erosion score (a measure of bone erosion in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The erosion score runs from 0 to 250 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.|Baseline to 3 months|Intent-to-treat population||Score||Standard Deviation|Mean
118042|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 2|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 2 weeks|2 weeks|Intent-to-treat population||Participants|||Number
118043|NCT00665626|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 1|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 1 week.|1 week|Intent-to-treat population||Participants|||Number
118044|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant||Participants|||Number
118045|NCT00665626|Secondary|Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months|Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with ESR as Primary Phase Reactant||Participants|||Number
118046|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant||Participants|||Number
118047|NCT00665626|Secondary|Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months|Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms|3 months|Intent-to-Treat Population with CRP as Primary Phase Reactant||Participants|||Number
118048|NCT00665626|Secondary|American College of Rheumatology Index of Improvement (ACRn) at 3 Months|The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment|3 months|Intent-to-treat population||Score||Standard Deviation|Mean
118049|NCT00665626|Secondary|American College of Rheumatology 70 (ACR70) Response at 3 Months|The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population||Participants|||Number
118050|NCT00665626|Secondary|American College of Rheumatology 50 (ACR50) Response at 3 Months|The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months|3 months|Intent-to-treat population||Participants|||Number
118051|NCT00665626|Primary|American College of Rheumatology 20 (ACR20) Response at 3 Months|The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months|3 months|Intent-to-treat population||Participants|||Number
118052|NCT00665470|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V3.0|Here is the number of participants with adverse events. For a detailed list of participants with adverse events, see the adverse event module.|16 months|||Participants|||Number
118053|NCT00665470|Primary|Response|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|30 months|||Participants|||Number
118054|NCT00665444|Secondary|Hamilton Rating Scale for Depression||3 months||||||
118055|NCT00665444|Secondary|Young Mania Rating Scale||3 months||||||
118056|NCT00665444|Secondary|Quality of Life Enjoyment Questionnaire||3 months||||||
118057|NCT00665444|Secondary|Global Assessment of Functioning||3 months||||||
118058|NCT00665444|Primary|Epworth Sleepiness Scale (General Level of Daytime Sleepiness)|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|3 month|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|||||
118059|NCT00665444|Primary|BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|3 months|0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.|||||
118060|NCT00665431|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
118061|NCT00665431|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
118062|NCT00665431|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat||percent days||Standard Deviation|Mean
118063|NCT00665431|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|12 weeks|intent to treat with last observation carried forward||Scores on a scale||Standard Deviation|Mean
118064|NCT00665431|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks|Intent to treat||Tablets per subject||Standard Deviation|Mean
118065|NCT00665431|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat||mm||Standard Deviation|Mean
118066|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
118067|NCT00665431|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
118068|NCT00665431|Secondary|Mean Change From Baseline in American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|For APS-POQ score is the change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to treat||Units on a scale||Standard Deviation|Mean
118069|NCT00665431|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
118070|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
118071|NCT00665431|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 Weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
118072|NCT00665366|Secondary|Change From Baseline to Week 12 in Body Mass Index (BMI) (LOCF Data Set)|BMI=Weight in kilograms /(Height in meters^2). LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.||kg/m^2||Full Range|Median
118073|NCT00665366|Secondary|Percentage of Participants With Relevant Weight Gain or Weight Loss From Baseline at Week 12 (LOCF Data Set)|Relevant weight gain=7% or greater increase in weight; relevant weight loss=7% or greater decrease in weight. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.||Percentage of participants|||Number
118074|NCT00665366|Secondary|Change From Baseline in Participant Weight (OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change.OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication. n=number of evaluable participants.||Kilograms||Standard Error|Mean
118075|NCT00665366|Secondary|Participant Scores on Patient Global Impression Improvement (PGI-I) Scale (OC Data Set)|Adjusted Mean Scores. The PGI-I is a self-administered 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
118076|NCT00665366|Secondary|Change From Baseline in Total Score on the Longitudinal Interval Follow-up Evaluation-Rating Impaired Functioning Tool (LIFE-RIFT)(OC Data Set and Week 12 LOCF Data Set)|Adjusted mean change. The LIFE-RIFT total score ranges from 4 to 20 and is the sum of scores of 4 items: work, interpersonal relations, satisfaction, and recreation. A negative change score signifies improvement. OC=observed cases; LOCF=last observation carried forward.|Baseline to Weeks 6 and 12|All randomized participants who received at least 1 dose of study medication and had at least 1 outcome research evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
118077|NCT00665366|Secondary|Percentage of Participants Showing Remission in the Young Mania Rating Scale (YMRS) Score From Baseline (LOCF Data Set)|Remission is defined as a YMRS total score of 12 or less. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Weeks 3,6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Percentage of participants|||Number
118078|NCT00665366|Secondary|Percentage of Participants Showing A Response From Baseline on the Young Mania Rating Scale (YMRS)(OC Data Set)|Response on the YMRS is defined as a 50% or greater improvement from baseline in YMRS total score. The YMRS is clinician-administered and consists of 11 multiple choice items. It is used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. OC=observed cases.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Percentage of participants|||Number
118079|NCT00665366|Secondary|Change From Baseline in Total and Subscale Scores on the Functional Assessment Short Test (FAST)(LOCF Data Set)|The FAST is an interview-administered instrument used to assess the main functioning problems that patients with bipolar disorder experience. Participants are rated at Baseline, Week 3, Week 6, Week 9, and Week 12/End of Study Visit. The FAST consists of 24 items that assess impairment or disability in 6 specific areas of functioning, categorized as the subscales: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal (IP) relationships, and leisure time. All items are rated using a 4-point scale, 0=no difficulty, 1=mild difficulty, 2=moderate difficulty, and 3=severe difficulty. The global score is the sum of the scores of all items and ranges from 0 (0*24)to 96 (4*24). The higher the global score, the higher the level of impairment. function=functioning. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 outcomes research evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
118080|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Overall) Scale at Week 12 (LOCF Data Set)|Adjusted mean change. The CGI-BP is scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
118108|NCT00664560|Primary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
123908|NCT00608491|Secondary|Change in Blood Potassium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
118081|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Depression) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
118082|NCT00665366|Secondary|Change From Baseline in Score on Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness (Mania) Scale (LOCF Data Set)|Adjusted mean change. The CGI-BP is a scale used to assess a clinician's impression of a patient's illness. Each patient is rated at baseline and at subsequent visits on items related to severity of depression, mania, and overall bipolar illness. The CGI-BP is a 7-point scale, with scores ranging from 1=normal/not ill to 7=very severely ill. Higher total score indicates greater severity of illness. LOCF=last observation carried forward.|Baseline to Weeks 3, 6, 9, and 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug. n=number of evaluable participants.||Units on a scale||Standard Error|Mean
118083|NCT00665366|Primary|Change From Baseline in Total Score on the Young Mania Rating Scale (YMRS) (LOCF Data Set)|The YMRS is a clinician-administered scale, consisting of 11 multiple choice items, and used to assess a patient’s manic symptoms and clinical condition over the previous 48 hours. Total scores range from 0 to 60, with 12 or greater signifying hypomania or mania. Each item is given a severity rating ranging from 0 to 8 or 0 to 4. Items for the scale are based on the core symptoms of mania: elevated mood, increased motor activity, sexual interest, sleep, irritability, speech (rate and amount), language-though disorder, content, disruptive-aggressive behavior, appearance, and insight. Scores for each item reflect the severity of that symptom in the patient. The test is administered during a clinical interview typically lasting 15-30 minutes. LOCF=last observation carried forward.|Baseline to Week 12|All randomized participants who received at least 1 dose of study medication and who had at least 1 efficacy evaluation after the start of study drug.||Units on a scale||Standard Error|Mean
118084|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Fasting Total Cholesterol and Triglycerides.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 fasting lipid results.||mg/dL||Inter-Quartile Range|Median
118085|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 HOMA-IR results.||mg/dL x uIU/mL / 405||Inter-Quartile Range|Median
118086|NCT00665353|Secondary|Absolute Change From Entry to Week 24 of Step 1 in AST and ALT.||From Entry to Week 24 of Step 1|Subjects with both Entry and Week 24 LFT results.||x ULN||Inter-Quartile Range|Median
118087|NCT00665353|Secondary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 72of Step 2.||Week 72 of Step 2|All enrolled subjects.||proportion of participants||90% Confidence Interval|Number
118088|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 2 (Up to 72 weeks)|All subject enrolled in Step 2.||participants|||Number
118089|NCT00665353|Secondary|Safety and Tolerability|Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality.|Step 1 (Up to 24 to 28 weeks)|All enrolled subjects.||participants|||Number
118090|NCT00665353|Primary|The Proportion of All Subjects With HCV Viral Load < 60 IU/mL at Week 24 of Step 2.||Week 24 of Step 2|All enrolled subjects.||proportion of participants||90% Confidence Interval|Number
118091|NCT00665132|Secondary|Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5|Using Brief Pain Inventory questions 14 and 15, those 9 subjects who had pain change from Baseline to Day 5 were analyzed to determine change in pain for the overall group. In the BPI, an 11-point NRS is used to rate pain intensity, with a 0 for ‘‘no pain’’ and a 10 for ‘‘pain as bad as you can imagine.’’ At Baseline, patients circled the number that best described how much baseline pain they had 'on average' (BPI #14). During the study, patients circled the one number that best described how much pain they had at the time 'right now' (BPI #15).|Day 5 after final stimulation|Nine subjects who reported change after 5 days of StimRouter System use are analyzed to determine mean change in pain from Baseline to Day 5 of Stimulation for the overall group.||units on a scale||Standard Deviation|Mean
118092|NCT00665132|Secondary|Percent of Participants Reporting Pain Change From Baseline to Day 5|Brief Pain Inventory (BPI) questions 14 and 15 were used to measure pain change after 5 days use of StimRouter System. In the BPI, an 11-point numerical rating scale (NRS) is used to rate pain intensity, where zero (0) indicates ‘‘no pain’’ and 10 indicates ‘‘pain as bad as you can imagine.’’ At enrollment, participants circled the number that best described how much baseline pain they had 'on average' (BPI #14). After enrollment and during the study, patients circled the one number that best described how much pain they had at that time 'right now' (BPI #15). The percent of participants with change from Baseline to Day 5 was calculated.|Day 5|All ten participants were analyzed.||percentage of patients|||Number
118093|NCT00665132|Secondary|Patent Satisfaction|Numerical rating scale (NRS) of 0-10 where 0 = not satisfied and 10 = very satisfied|Day 5 after final stimulation|All ten subjects responses were analyzed.||units on a scale||Standard Deviation|Mean
118094|NCT00665132|Primary|Implant Success|Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed.|at device implantation procedure|||participants with successful implant|||Number
118806|NCT00659789|Secondary|Immunogenicity|Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema|Week 1, week 18 and week 52|ITT Population||participants|||Number
118095|NCT00665002|Secondary|Participants Whose Samples Demonstrated Immunological Response After Vaccination|"Immune Response: Immune reactivity was measured for all participants. Immune response was measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT and/or multiparameter intracellular staining by flow cytometry were performed as well.~ELISPOT Assay: CD4+ immune response, CD4+ and CD8+ response. The samples of participants' blood obtained at baseline and week 12 were tested for CD4 T cell proliferation, CD4 and CD8 T cell interferon release.~Tetramer Analysis of WT1-specific Immune responses: subtle WT1 T cell expansion, positive by ELISPOT and T cell expansion.~Delayed-type Hypersensitivity (DTH): measurable DTH response without overlap with ELISPOT or tetramer responders).~Overall: any form of immune response."|12 weeks|All participants||participants|||Number
118096|NCT00665002|Primary|Number of Participants With Adverse Events (AEs)|Toxicities were tabulated according to the NCI Common Toxicity (version 3.0) by grade and category. If more than one patient developed ≥ grade 3 non-hematologic toxicity or grade 4 hematologic toxicity, the study accrual was to be suspended immediately for a careful toxicity data evaluation. Depending upon the findings of such safety/toxicity data assessment and consultation with the supporting pharmaceutical company, the principal investigator of this trial would have the option of terminating this trial permanently, amending the study protocol, or resuming the patient accrual.|12 weeks to 6 months|All participants||participants|||Number
118097|NCT00664742|Secondary|Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels|The percentage of participants who achieved the following predefined lipid target levels at Baseline and at 6 months: TC <200 mg/dL, LDL-C <100 mg/dL, HDL-C >=60 mg/dL and TG < 150 mg/dL.|Baseline, 6 weeks|This analysis was done on the safety population which consists of all participants who received at least one dose of study medication.||Percentage of Participants|||Number
118098|NCT00664742|Primary|Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6|Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.|Baseline,6 weeks|The analysis was done on the Per Protocol Population which consists of all participants who did not violate inclusion/ exclusion criteria, completed the treatment study phase or withdrew from the study due to progression, death, or toxicity (AE related to study drug) and had at least one key response evaluation.||mg/dL||95% Confidence Interval|Mean
118099|NCT00664560|Secondary|The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event|The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
118100|NCT00664560|Secondary|Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms|Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.|daily during 12 weeks|Safety population||participants|||Number
118101|NCT00664560|Secondary|Percent of Days With no Heartburn (Heartburn Resolution)|During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).|12 weeks|Intent to treat||percent days||Standard Deviation|Mean
118102|NCT00664560|Secondary|Modified Severity of Dyspepsia Assessment (mSODA)|Change from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
118103|NCT00664560|Secondary|Antacid Tablet Use|Tablet pill count|12 weeks|||Tablets per subject||Standard Deviation|Mean
118104|NCT00664560|Secondary|Change in Patient Global Assessment (PGA) Subscore From Baseline|PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.|Week 6|Intent to treat||mm||Standard Deviation|Mean
118105|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
118106|NCT00664560|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Week 6|Intent to treat||mm||Standard Deviation|Mean
118107|NCT00664560|Secondary|American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.|Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.|Baseline and Day 7|Intent to Treat||Units on a scale||Standard Deviation|Mean
118833|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded.||mmHg||Standard Deviation|Mean
118109|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline|"WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain from baseline (in mm).~The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
118110|NCT00664560|Primary|Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline|"Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being no pain and 100 mm being extreme pain. The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function)."|Baseline and 12 weeks|Analysis Population: Baseline + took >= 1 dose + >= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward||mm||Standard Deviation|Mean
118111|NCT00664534|Secondary|Number of Participants With Adverse Events|"A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.~TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline."|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period.||participants|||Number
118112|NCT00664534|Secondary|Rate Per 30 Days of All Self-reported Hypoglycemic Episodes|The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.||episodes per 30 days||Standard Deviation|Mean
118113|NCT00664534|Secondary|Incidence of All Self-reported Hypoglycemic Episodes|Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).|Baseline to 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.||percentage of participants|||Number
118114|NCT00664534|Secondary|Body Weight Change From Baseline to Endpoint||baseline, 48 weeks|Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.||kilograms (kg)||95% Confidence Interval|Least Squares Mean
118115|NCT00664534|Secondary|Mean Daily Total, Basal and Prandial Insulin Dose||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||International Units per day (IU/day)||Standard Deviation|Mean
118116|NCT00664534|Secondary|Mean Postprandial Blood Glucose Values|Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||microgram per milliliter (µg/mL)||Standard Deviation|Mean
118117|NCT00664534|Secondary|7-point Self-monitored Blood Glucose Profiles||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
118118|NCT00664534|Secondary|Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time||16 weeks, 32 weeks and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||percentage of participants|||Number
118119|NCT00664534|Secondary|HbA1c Over Time|Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population.|16 weeks, 32 weeks, and 48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
118120|NCT00664534|Secondary|Percentage of Participants Using Each Possible Final Insulin Regimen|"Insulin Regimens:~Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro."|48 weeks|Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had a measurement for the dependent variable at the time point, according to intent-to-treat (ITT) principles.||percentage of participants|||Number
123909|NCT00608491|Secondary|Change in Blood Sodium Level||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mEq/L||Standard Deviation|Mean
118121|NCT00664534|Primary|Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint|Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.|48 weeks|"PP Population=All participants who were randomized and met following criteria during study:~no violations of Inclusion/Exclusion Criteria~no early study discontinuation~compliant with treatment~received no other antihyperglycemic medication than allowed in Protocol, and have not been on systemic glucocorticoids for >14 consecutive days."||percent glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
118122|NCT00664521|Secondary|Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells|Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels.|Baseline, Week 3, 7, 12, 16, 26 and 32|Safety population included all participants who received at least one dose of atacicept or placebo. Here 'n' signifies those participants who were evaluable for the specified category.||percent change||Inter-Quartile Range|Median
118123|NCT00664521|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 score ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Baseline, Week 32|ITT population included all randomized participants. Here 'n' signifies those participants who were evaluable for the specified category.||Units on a scale||Standard Deviation|Mean
118124|NCT00664521|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32|ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP.|Week 32|ITT population included all randomized participants.||percentage of participants|||Number
118125|NCT00664521|Primary|Percent Change From Baseline in Anti-pneumococcus Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||percent change||Inter-Quartile Range|Median
118126|NCT00664521|Primary|Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32|Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here. N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."||percent change||Inter-Quartile Range|Median
118127|NCT00664521|Primary|Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32|Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.|Baseline, Week 32|"Safety population included all participants who received at least one dose of atacicept or placebo. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for the specified category."||Percent change||Standard Deviation|Mean
118128|NCT00664521|Primary|Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)||Week 64|Safety population included all participants who received at least one dose of atacicept or placebo. Here. “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
118129|NCT00664521|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 64|Safety population included all participants who received at least one dose of atacicept or placebo.||Participants|||Number
118130|NCT00664430|Secondary|Number of Participants With Adverse Events|The occurrence of adverse events was considered a secondary endpoint in this study. For details on adverse events that occurred prior to study termination, refer to the safety section below.|Up to 1 year|||Participants|||Number
118131|NCT00664430|Secondary|Changes in Bone Remodeling Markers Over Time|Deoxypyridinoline and bone-specific alkaline phosphatase levels were to be measured every 3 months and changes over time analyzed using descriptive statistics.|Every 3 months|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the secondary analysis.||ng/mL||Standard Deviation|Mean
123361|NCT00614315|Primary|Technical Success for Delivery|defined as deployment of the implant to the intended location, assessed at the time of the index procedure.|Measured at the time of implantation (Day 0)|||Percentage of successful implantations|||Number
118132|NCT00664430|Primary|Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values|This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.|Up to Week 24|No efficacy analysis was performed in this study. At the time the study was stopped, 3 participants were receiving paricalcitol, but none of them had reached the time point for the primary analysis.||Proportion of participants|||Number
118133|NCT00664326|Other Pre-specified|Duration of Stable Disease (Update)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.||Days||95% Confidence Interval|Median
118134|NCT00664326|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.||Days||95% Confidence Interval|Median
118135|NCT00664326|Other Pre-specified|Duration of Response (Update)|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.||Days||95% Confidence Interval|Median
118136|NCT00664326|Secondary|Duration of Response|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Only subjects from ITT population with a response of CR or PR were included in this evaluation.||Days||95% Confidence Interval|Median
118137|NCT00664326|Other Pre-specified|Time to Progression (Update)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
118138|NCT00664326|Secondary|Time to Progression (TTP)|TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
118139|NCT00664326|Other Pre-specified|Progression-free Survival (Update)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
118140|NCT00664326|Secondary|Progression-free Survival (PFS)|PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
118141|NCT00664326|Other Pre-specified|Overall Survival (Update)|Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).|intention-to-treat (ITT)||Days||95% Confidence Interval|Median
118236|NCT00663208|Primary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.||log10 IU/mL||90% Confidence Interval|Mean
118143|NCT00664326|Other Pre-specified|Disease Control (Update)|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
118144|NCT00664326|Secondary|Disease Control|Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
118145|NCT00664326|Other Pre-specified|Tumor Response (Update)|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
118146|NCT00664326|Primary|Tumor Response|Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
118147|NCT00664326|Other Pre-specified|Objective Tumor Response (Update)|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the RECIST committee.|From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
118148|NCT00664326|Primary|Objective Tumor Response|Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.|From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks|Evaluable for response (Primary analysis population)||Percentage of participants|||Number
118149|NCT00664105|Secondary|Number of Participants With Adverse Events by Grade|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event|30 days after last treatment.|Patients who received treatment and who experienced an adverse event.||participants|||Number
118150|NCT00664105|Secondary|Time to Disease Progression|Time to disease progression in months|on-study date to date of progression|Patients with disease progression.||Months||Full Range|Median
118151|NCT00664105|Secondary|Overall Response Rate|"Patient response to treatment per RECIST:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|on-study date to date of best response|Patients who were available for measurement of response. Six patients were not available for measurement of response and are not included in the analyzed population||participants|||Number
118152|NCT00664105|Primary|Overall Survival|Months from on-study to expired/last date known alive.|14.95 months (average duration, on study date to off-study date)|Patients who received at least one treatment and who were available for determination of overall survival.||Months||Full Range|Median
118153|NCT00664066|Primary|Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|up to 3 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.||Participants|||Number
118154|NCT00663962|Primary|Incidence of Chronic Post-thoracotomy Pain at 2 Months Postoperatively|Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale)|2 months postoperatively|pilot study--convenience||participants|||Number
118155|NCT00663962|Primary|The Primary Outcome Measure for the Final Study Will be the Incidence of CPTPS at 2 Months.||2, 4, and 6 months||||||
118156|NCT00663923|Secondary|Surgically Induced Astigmatism|"It is the vector of the astigmatic change actually induced by the surgery.Participant population was the same as baseline participants.~It was measured by refraction(using autorefractor) and vector analysis(using special software).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters"|six months after surgery|||Diopter||Standard Deviation|Mean
118157|NCT00663923|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|UCDVA is attained without correction of refractive errors .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart( the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol||LogMAR|Participants|Standard Deviation|Mean
118158|NCT00663923|Secondary|Corrected Distance Visual Acuity(CDVA)|CDVA is attained after correction of refractive errors using lenses of varying powers .the data are the LogMAR values calculated from the snellen chart using the visual acuity conversion chart(the units would be LogMAR).Any patient with better vision can see the smallest letters at 20 feet(20/20=0.00 LogMAR).Higher LogMAR values represent worse outcome.Log MAR(logarithmic minimum angle of resolution)notation ,has gained widespread use in statistical calculations.|six months|the analysis was per protocol||LogMAR|Participants|Standard Deviation|Mean
118159|NCT00663923|Secondary|Higher Order Aberrations|Although lower- order aberrations decrease after laser vision correction,higher -order aberrations may increase after conventional PRK or LASIK(Laser in situ keratomileusis).Higher-order aberration is Composed of delicate irregularities within the cornea not correctable by spectacles.It is measured using aberrometer.In this study OPD scan was used that is one of the methods of wavefront analysis .|six months postoperative|the analysis was per protocol.||micron|Participants|Standard Deviation|Mean
118160|NCT00663923|Primary|Correction of Astigmatism|It shows the result of correction of astigmatism .In compound myopic astigmatism the meridians of maximum and minimum power are both too strong.So both line images fall short of the retina.It is measured by refraction(using autorefractor).Diopter is a unit of measurement of the optical power of any refracting surface ,which is reciprocal of the focal length measured in meters.|six months after surgery|"The sample size was determined by the one proportion formula where power = 0.8, d=0.02 , p= 0.5(primary outcome) and type I error probability associated with this test of null hypothesis is 0.05.~The analysis was per protocol"||diopter|Participants|Standard Deviation|Mean
118161|NCT00663858|Primary|International Prostate Symptom Score (IPSS)|IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks|||Units on a scale||Standard Deviation|Mean
118162|NCT00663819|Secondary|Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.||study completion||||||
118163|NCT00663819|Secondary|Provide a Cost/Benefit Analysis With Regard to the Use of CBSG in Stapled Circular Anastomoses||study completion||||||
118164|NCT00663819|Secondary|Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses||post operative||||||
118165|NCT00663819|Secondary|Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.||post operative||||||
118166|NCT00663819|Primary|Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak|The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.|completion of procedure through 4-12 weeks post procedure|||percentage of subjects|||Number
118167|NCT00663793|Secondary|Area Under the Curve-E2||14 Days|||nmol*h/L||Standard Deviation|Mean
118168|NCT00663793|Secondary|Area Under the Curve-serum DHT||14-days|||nmol*h/L||Standard Error|Mean
118169|NCT00663793|Primary|Area Under the Curve-Serum T||14 days|||nmol*h/L||Standard Error|Mean
118170|NCT00663702|Primary|Mean Temperature|Temperature was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable||Degrees Celsius||Standard Deviation|Mean
118171|NCT00663702|Primary|Mean Heart Rate|Heart rate was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable||Beats per minute||Standard Deviation|Mean
118172|NCT00663702|Primary|Mean Sitting Systolic and Diastolic Blood Pressure (BP)|BP was measured after the patient had been seated quietly for at least 5 minutes and recorded during the screening visit, during every office visit prior to administration of subcutaneous injections, and at study discharge or 7 days after the last dose for patients who terminated early.|Before injection on Days 1, 29, 57, 85, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, and 1821|All participants who received at least 1 dose of study medication. n=patients evaluable||mm Hg||Standard Deviation|Mean
118173|NCT00663702|Primary|Number of Participants With Adverse Events of Special Interest|AEs of special interest are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions (defined as local injection site reactions and systemic injection reactions occurring within 24 hours of subcutaneous injection).|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication.||Participants|||Number
118174|NCT00663702|Primary|Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality|preRX=pretreatment. For all values analyzed (protein, urine; glucose, urine; blood, urine: leukocyte esterase, urine; white blood cells, urine; red blood cells, urine): If missing preRx, use >=2 or, if value >= 4, or if preRx=0 or 0.5, use >=2 or, if preRx= 1, use >=3 or, if preRx=2 or 3, use >=4.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
118175|NCT00663702|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time|The HAQ-DI assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories is divided by the number of categories answered, yielding a score from 0-3.|Day 1 (Baseline) to Day 1093|All participants who received at least 1 dose of study medication||Units on a scale||Standard Deviation|Mean
118176|NCT00663702|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) and Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Remission Over Time:|LDAS is defined as DAS 28-CRP ≤3.2. DAS 28-CRP remission is defined as DAS 28-CRP <2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication||Percentage of participants||95% Confidence Interval|Number
118177|NCT00663702|Secondary|Mean Disease Activity Score 28 Based on C-reactive Protein (DAS 28-CRP) Scores Over Time|The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), C-reactive protein level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Day 1 (Baseline) through Day 1093|All participants who received at least 1 dose of study medication||Units on a scale||Standard Deviation|Mean
118178|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) at Day 85|"Number of participants was tabulated using ECL assay with at least 1 positive abatacept-induced immunogenic response (CTLA4 and possibly Ig, Ig and/or Junction Region) in the first 85 days. Positive response (titers >10) included:~A missing baseline immunogenicity measurement and a positive immunogenicity response postbaseline~A negative baseline immunogenicity response and a positive immunogenicity response postbaseline~A positive baseline immunogenicity response and a positive immunogenicity response postbaseline that has a titer value strictly greater than the baseline titer value"|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable||Percentage of participants|||Number
118179|NCT00663702|Secondary|Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) at Day 85|Using the ELISA, any positive (titer of 400 or greater) postbaseline sample was classified as positive immunogenicity. The percentage of participants with at least 1 positive antibody response (anti-abatacept and/or anti-CTLA4-T) during the 85 days was tabulated by antibody specificity and overall.|Day 1 (Baseline) through Day 85|All participants who received at least 1 subcutaneous abatacept injection and who had at least 1 immunogenicity result reported (on the corresponding assay) on subcutaneous abatacept treatment. n=patients evaluable||Percentage of participants|||Number
118180|NCT00663702|Primary|Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality: .|Day 1 (Baseline) to up to 56 days past the last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
118181|NCT00663702|Primary|Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Sodium: <0.95*LLN or >1.05*ULN or if preRx<LLN, <0.95*preRx or >ULN, or if preRx>ULN,>1.05*preRx or <LLN. Potassium,serum: <0.9*LLN or >1.1*ULN or if preRx<LLN, use <0.9*preRx or >ULN or if preRx>ULN, 1.1*preRx or <LLN. Phosphorus: 0.75*LLN or 1.25*ULN or, if preRx<LLN, <0.67*preRx or >ULN or, if preRx>ULN, <LLN.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
118182|NCT00663702|Primary|Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (U/L) >2*ULN or if preRx>ULN, use 3*preRx. Alanine aminotransferase (U/L)>3*ULN or if preRx>ULN, use >4*preRx. G-glutamyl transferase (U/L)>2*ULN or if preRx>ULN, use >3*preRx. Blood urea nitrogen (mg/dL)>2*preRx. Creatinine (mg/dL)>1.5*preRx.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
118183|NCT00663702|Primary|Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment. Marked abnormality criteria: Hemoglobin (g/dL) >3 decrease from preRx. Hematocrit (%)<0.75*preRx. Erythrocytes (*10^6 c/uL) <0.75*preRx. Platelet count (*10^9 c/L) <0.67*LLN or 1.5*ULN or, if preRx<LLN, use <0.5*preRx and <100,000 mm^3. Leukocytes (*10^3 c/uL) <0.75*LLN or >1.25*ULN or, if preRx<LLN, use <0.8*preRx or >ULN or, if preRx>ULN, use >1.2*preRx or <LLN. Eosinophils >0.750*10^3 c/uL. Lymphocytes <0.750*10^3 c/uL or >7.50*10^3 c/uL.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication. n=patients evaluable||Participants|||Number
118237|NCT00663208|Secondary|Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA Levels of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 international units/ millilitre (IU/mL). Baseline was Day -1|Baseline, Day 7|All randomized participants who took at least 1 dose of study medication.||log10 IU/mL||90% Confidence Interval|Mean
118184|NCT00663702|Primary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators.|Day 1 (Baseline) through 56 days past last day of subcutaneous injection in the cumulative study period|All participants who received at least 1 dose of study medication||Participants|||Number
118185|NCT00663702|Secondary|Mean Trough Serum Concentration (Cmin) of Abatacept|Cmin of abatacept was determined from serum samples.|Days 29, 85, 57, and 85|All participants who received at least 1 dose of study medication. n=patients who had at least 1 pharmacokinetic sample drawn postbaseline||μg/mL||Geometric Coefficient of Variation|Geometric Mean
118186|NCT00663702|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Treatment-related Adverse Events (AEs), AEs Leading to Discontinuation, and AEs of Interest (AEIs) at Day 85|An AE is a new or worsening illness, sign, or symptom or a clinically significant abnormal laboratory test result occurring during the study, regardless of causality, and noted by the investigators. Systemic injection reaction occurring ≤ 24 hours after dosing.|Day 1 (Baseline) through Day 85|All participants who received at least 1 dose of study medication||Participants|||Number
118187|NCT00663403|Secondary|Daptomycin Free Fraction|"In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the free component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria."|From time of daptomycin administration to 48 hours post dose|||percent protein binding||Standard Deviation|Mean
118188|NCT00663403|Secondary|Daptomycin Half-life|Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis|||hours||Standard Deviation|Mean
118189|NCT00663403|Secondary|Daptomycin Total Body Clearance|Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis|||mL/min/kg||Standard Deviation|Mean
118190|NCT00663403|Secondary|Daptomycin Volume of Distribution at Steady State|Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body.|From time of daptomycin administration to 48 hours post dose|||L/kg||Standard Deviation|Mean
118191|NCT00663403|Secondary|Observed Daptomycin Peak Serum Concentration|The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min.|At the end of the daptomycin intravenous infusion (at approximately 30 minutes)|||ug/mL||Standard Deviation|Mean
118192|NCT00663403|Secondary|Daptomycin Dose Actually Administered||Time of daptomycin administration|||mg/kg||Standard Deviation|Mean
118193|NCT00663403|Primary|Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis|Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.|From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis|||mL/min||Standard Deviation|Mean
118194|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)||kg||Standard Error|Mean
118195|NCT00663260|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
118196|NCT00663260|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||% of hemoglobin||Standard Error|Mean
118834|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded.||mmHg||Standard Deviation|Mean
118197|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
118198|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
118199|NCT00663234|Secondary|Percentage of Participants With Undetectable Plasma HIV-1 RNA|Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.|Study entry and weeks 12, 24, and 48|All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week.||percentage of participants||90% Confidence Interval|Number
118200|NCT00663234|Secondary|Percent Change in Interleukin 6 (IL-6) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week.||percentage of IL-6 at study entry||90% Confidence Interval|Median
118201|NCT00663234|Secondary|Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week.||percentage of hs-CRP at study entry||90% Confidence Interval|Median
118202|NCT00663234|Secondary|Percent Change in Apolipoprotein B (Apo B) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week.||percentage of Apo B at study entry||90% Confidence Interval|Mean
118203|NCT00663234|Secondary|Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry||Study entry and weeks 12, 24, and 48|All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week.||percentage of Apo A-1 at study entry||90% Confidence Interval|Mean
118204|NCT00663234|Secondary|Percent Change in HDL-cholesterol (HDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week.||percentage of HDL-C at study entry||90% Confidence Interval|Mean
118205|NCT00663234|Secondary|Percent Change in Triglycerides (TG) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week.||percentage of TG at study entry||90% Confidence Interval|Mean
118206|NCT00663234|Secondary|Percent Change in Fasting Total Cholesterol (TC) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week.||percentage of TC at study entry||90% Confidence Interval|Mean
118207|NCT00663234|Primary|Percent Change in LDL Cholesterol (LDL-C) From Study Entry||Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week.||percentage of LDL-C at study entry||90% Confidence Interval|Mean
118208|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.||percentage of participants||90% Confidence Interval|Number
118209|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.||percentage of participants||90% Confidence Interval|Number
118210|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin.||percentage of participants||90% Confidence Interval|Number
118211|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who completed the study per protocol (initiated study drug, had LDL-C data available at all required study visits, attended study visits within the protocol-specified window, were dose-escalated according to protocol, and reported adherence to study drug at all study visits).||percentage of participants||90% Confidence Interval|Number
118212|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated study treatment and have LDL-C data available at study entry and the specified week.||percentage of participants||90% Confidence Interval|Number
118213|NCT00663234|Primary|Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)|Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.|Study entry and weeks 4, 12, 24, and 48|All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week.||percentage of participants||90% Confidence Interval|Number
125618|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Other’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
118214|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
118215|NCT00663234|Primary|Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)|AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.|Study entry to weeks 12, 24, and 48|All participants who initiated Atorvastatin.||percentage of participants||90% Confidence Interval|Number
118216|NCT00663208|Secondary|Number of Participants Meeting Pre-Specified Criteria in Electrocardiogram Parameters|Pre-specified criteria were defined as, Heart rate (HR) minimum as <=50 bpm/change from baseline <-20 bpm/maximum HR >100 bpm, QT interval corrected using Fridericia's formula (QTcF) maximum as QTcF<=450 msec/450 msec <maximum QTcF and <=480 msec/480 msec <maximum QTcF <= 500 msec/maximum QTcF>500 msec, QRS interval as <=120 msec/>120 msec, and PR interval maximum as <= 200 msec/>200 msec.|Screening, Day 2, 3, 5, 7, 9, 11, 13, 15, 21 and 28|All participants treated with study drug were summarized.||participants|||Number
118217|NCT00663208|Secondary|Number of Participants With Clinically Relevant Change From Baseline in Vital Signs|Vital signs included: body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. Blood pressure and heart rate were measured after the participant had been supine, semi-supine, or seated quietly for at least 5 minutes. Baseline was defined as the last observation prior to dosing on Day 1.|Screening, Day -1 and prior to morning dose on Day 1, 2, 14, and 28|All participants treated with study drug were summarized.||participants|||Number
118218|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Urinalysis|Marked laboratory abnormalities in urinalysis were defined as, Blood Urine High as >= 2*PreRx if PreRx >= 1/>= 2 if PreRx < 1/>= 2 if PreRx = Missing. Glucose Urine High as >= 1 if PreRx < 1/>= 1 if PreRx = Missing/>= 2*PreRx if PreRx >= 1.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.||participants|||Number
118219|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Lipase and Glucose|Marked abnormalities were defined as Lipase (U/L) High as >1.5*ULN, Glucose fasting serum (mg/dL) High as > 1.3*ULN if LLN <= PreRx <= ULN/> 1.3*ULN if PreRx = Missing/>2*PreRx; if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.||participants|||Number
118220|NCT00663208|Secondary|Number of Participants With Marked Abnormalities in Liver and Kidney Function Laboratory Tests and Electrolytes|Liver and kidney function marked laboratory abnormalities were defined as Alanine Aminotransferase (ALT) units per liter (U/L) High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Aspartate Aminotransferase (AST) U/L High as > 1.25* PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, Alkaline Phosphatase(ALP)U/L High as > 1.25*PreRx if PreRx > ULN/> 1.25*ULN if PreRx <= ULN/> 1.25*ULN if PreRx = Missing, G-Glutamyl Transferase (GGT) in U/L High as >1.15*ULN if PreRx<=ULN/>1.15* if PreRx missing/>1.2* PreRx if PreRx>ULN, Phosphorus Inorganic (mg/dL) Low as < 0.85*LLN if LLN <= PreRx <= ULN/< 0.85*LLN if PreRx = Missing/< 0.85*PreRx if PreRx < LLN/< LLN if PreRx > ULN, and Potassium serum milliequivalents per liter (mEq/L) High as > 1.1*PreRx if PreRx > ULN/> 1.1*ULN if LLN <= PreRx <= ULN/> 1.1*ULN if PreRx = Missing/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants who were treated with study drug were summarized.||participants|||Number
118221|NCT00663208|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematology|Hematology marked laboratory abnormalities were defined as Hemoglobin (g/dL) Low as < 0.85*Pre-therapy (PreRx), Hematocrit (%) Low as < 0.85*PreRx, Platelet Count *10^9 c/L Low as < 0.85*Lower Limits of Normal (LLN) if PreRx = Missing/< 0.85*LLN if PreRx >= LLN/< 0.85*PreRx if PreRx < LLN, Eosinophils (absolute) *10^3 c/µL High as > 0.75*count, Leukocytes White Blood Cell (WBC) *10^3 c/µL High as > 1.2*ULN if LLN <= PreRx <= Upper Limits of Normal (ULN) > 1.2*ULN if PreRx = Missing/> 1.5*PreRx if PreRx > ULN/> ULN if PreRx < LLN.|Screening, Day 3, Day 7, Day 11, Day 14, and Day 28|All participants treated with study drug were summarized.||participants|||Number
118222|NCT00663208|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 182 or Day of Discharge|All participants who received study drug were summarized.||participants|||Number
118223|NCT00663208|Secondary|Correlation Coefficients Between Measures of Decline in log10 Hepatitis C Virus (HCV) RNA and Daclatasvir PK Parameters Cmax, AUC(TAU), and Cmin on Day 14 in Participants Without Baseline Drug Resistance|Correlation between decline of log10 hepatitis C virus (HCV) RNA and exposure to study drug was measured by Pearson Correlation Coefficients. The change from baseline at Day 4 in log10 HCV RNA and the maximum decline in log10 HCV RNA were evaluated against the PK parameters Cmax, Cmin and AUC(TAU).|Day 4, Day 14|All participants who received at least 1 dose of daclatasvir and who had no baseline genotype resistance were analyzed. Placebo participants were excluded from this analysis.||Correlation Coefficient|||Number
118224|NCT00663208|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir on Days 1 and 14|Tmax was defined as the time to reach maximum observed plasma concentration of daclatasvir in plasma. Tmax was derived from plasma concentration-time data analyzed by non-compartmental methods. Tmax of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||h||Full Range|Median
118225|NCT00663208|Secondary|Accumulation Index (AI) AUC(TAU), AI Cmax, and Degree of Fluctuation (DF) of Daclatasvir on Day 14|Accumulation index area under the concentration–time curve of daclatasvir to the end of the dosing period [AI AUC(TAU)] was defined as the ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose.Accumulation index maximum observed concentration of daclatasvir in plasma (AI Cmax) was defined as the ratio of Cmax at steady-state to Cmax after the first dose. Degree of Fluctuation (DF) was defined as the ratio of difference between Cmax and Cmin at steady state by Css-av. The parameters were analyzed using non-compartmental methods, assayed by validated liquid chromatography tandem mass spectrometry (LC-MS/MS).|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||ratio||Geometric Coefficient of Variation|Geometric Mean
118226|NCT00663208|Secondary|Average Observed Plasma Concentration (Css-av) at Steady State of Daclatasvir at Days 1 and 14|The average observed plasma concentration at steady state (Css-av) was calculated as ratio of AUC(TAU) by TAU, where TAU = 24 h for QD dosing and 12 h for BID dosing. Css-av was derived from plasma concentration-time data analyzed by non-compartmental methods. Css-av of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11,13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
118227|NCT00663208|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir on Day 14|The apparent total body clearance at steady state (CLT/F) was defined as the apparent body clearance of canakinumab from the serum when the systemic availability was unknown. CLT/F was derived from plasma concentration-time data analyzed by non-compartmental methods. CLT/F of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||mL/min||Geometric Coefficient of Variation|Geometric Mean
118228|NCT00663208|Secondary|Plasma Half-life (T-half) of Daclatasvir at Day 14|The absolute values of lamda (λ) were used to evaluate apparent terminal half-life (T-half) was defined as T-half= ln 2/λ. T-half was derived from plasma concentration-time data analyzed by non-compartmental methods. T-half of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||h||Standard Deviation|Mean
118229|NCT00663208|Secondary|Area Under the Concentration-time Curve (AUC) in 1 Dosing Interval of Daclatasvir at Days 1 and 14|The area under the concentration-time curve in 1 Dosing Interval AUC(TAU) was used to measure the drug exposure over 1 dosing interval., derived from plasma concentration-time data analyzed by non-compartmental methods. AUC(TAU) of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1,1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hr (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13, and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available PK data were summarized.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
118230|NCT00663208|Secondary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Daclatasvir on Days 1 and 14|The peak concentrations in plasma (Cmax) and minimum observed plasma concentration (Cmin) were defined as the peak maximum and minimum plasma level of daclatasvir, derived from plasma concentration-time data analyzed by non-compartmental methods. Cmax and Cmin of daclatasvir in plasma was assayed using a validated liquid chromatography tandem mass spectrometry method.|0 hour (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours (post morning dose) at Day1 and Day 14, 0 hour (pre-dose) at Days 2, 3, 4, 5, 7, 9, 11, 13 and 24, 48 and 72 hours (post morning dose) at Day 14|All participants who received at least 1 dose of study medication and with available Pharmacokinetic (PK) data were summarized.||nanograms/milliliters(ng/mL)||Geometric Coefficient of Variation|Geometric Mean
118231|NCT00663208|Secondary|Maximum Decline From Baseline in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||log10 IU/mL||Standard Deviation|Mean
118232|NCT00663208|Secondary|Time to Maximum Decline From Baseline in Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|Participants without baseline drug resistance were assessed for time to reach maximum decrease in log10 HCV RNA level.|Day 1 up to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||Days||Standard Deviation|Mean
118233|NCT00663208|Secondary|Change From Baseline to Day 14 in Log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 14|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||log10 IU/mL||90% Confidence Interval|Mean
118234|NCT00663208|Secondary|Change From Baseline to Day 4 in log10 Hepatitis C Virus (HCV) RNA in Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline to Day 4|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations.||log10 IU/mL||90% Confidence Interval|Mean
118235|NCT00663208|Secondary|Change From Baseline at 24 h Post Dose on Day 1 in log10 Hepatitis C Virus (HCV) RNA of Participants Without Baseline Drug Resistance|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Baseline was Day -1.|Baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours post dose on Day 1|All randomized participants who took at least 1 dose of study medication and did not have baseline genotypic drug resistance mutations were summarized.||log10 IU/mL||Standard Deviation|Mean
118238|NCT00663169|Secondary|Number of Patients Who Took Rescue Medication|Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.|4 months|All participants.||Participants|||Number
118239|NCT00663169|Secondary|Change From Baseline in Pain Using a Visual Analog Scale at Month 4|Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.||Score on a scale||Standard Deviation|Mean
118240|NCT00663169|Secondary|ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period|Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).|Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.||μg/mL||Standard Deviation|Mean
118241|NCT00663169|Secondary|Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.||mg/L||Standard Deviation|Mean
118242|NCT00663169|Secondary|Change in C-reactive Protein (CRP) From Baseline at Month 4|Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|Baseline, Month 4|Pharmacodynamic set included all randomized patients with evaluable (or complete) pharmacodynamic parameter data.||mg/L||Standard Deviation|Mean
118243|NCT00663169|Secondary|Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study|Additional safety information can be found in the Adverse Event section.|4 months|||Participants|||Number
118244|NCT00663169|Secondary|Time to Walk Independently (if Applicable) During Treatment Period||4 months|Since the study recruited only 6 subjects this analysis was not done.|||||
118245|NCT00663169|Secondary|Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period|Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.|4 months|Since the study recruited only 6 subjects this analysis was not done.|||||
118246|NCT00663169|Secondary|Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period||72 hours|Since the study only recruited 6 subjects this analysis was not done.|||||
118247|NCT00663169|Primary|Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale|72 hours following treatment, patients were asked the question: “How would you rate the improvement in your gout since receiving the study medication?” Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a “good” or “excellent” response.|72 hours|Pharmacodynamic set included all randomized subjects with evaluable (or complete) pharmacodynamic parameter data.||Percentage of participants|||Number
118248|NCT00663117|Secondary|Histology Inflammatory Score by Colon Biopsies|Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..|12 weeks|Tissue was removed by biopsy in those undergoing colonoscopy||units on a scale||Standard Error|Mean
118249|NCT00663117|Secondary|Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy|A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn’s Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983–989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of > 5 points from baseline. Endoscopic remission is a score of < 6 and Complete endoscopic remission is a score of > 3.|12 weeks|Sample size was calculated under the assumption that at least 60% of the naltrexone-treated patients, and no more than 10% of the placebo-treated patients, would respond with at least a 70-point decline in CDAI scores. With a 10% withdrawal rate, 40 subjects yields an 86% power using a two-sided, 0.05-significance level Fisher’s exact test.||percentage of patients|||Number
118250|NCT00663117|Secondary|Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)|IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.|Between baseline and 3 months|Same as sample size calculation||percentage of change||Standard Error|Mean
118251|NCT00663117|Primary|Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;|The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.|3 months|||percentage of pts|||Number
118252|NCT00663052|Other Pre-specified|Mean Number of Doctor Visits|As a part of pharmacoeconomic questionnaire, the mean number of doctor visits were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Visits||Standard Deviation|Mean
118391|NCT00662532|Primary|Overall PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 180|||mm||Standard Deviation|Mean
118253|NCT00663052|Other Pre-specified|Percentage of Participants With Doctor Visits|As a part of pharmacoeconomic questionnaire, the percentage of participants who had doctor visits were presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Percentage of participants|||Number
118254|NCT00663052|Other Pre-specified|Mean Number of Emergency Room Days|As a part of pharmacoeconomic questionnaire, mean number of emergency room days were summarized.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Days||Standard Deviation|Mean
118255|NCT00663052|Other Pre-specified|Percentage of Participants With Emergency Room Visits|As a part of pharmacoeconomic questionnaire, the visits to emergency room were evaluated and presented as Yes or No.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Percentage of participants|||Number
118256|NCT00663052|Other Pre-specified|Mean Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire Total Scores|FACIT Fatigue questionnaire: Participant rated 13 items questionnaire to assess fatigue. For each question, participant rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue. The total FACIT-Fatigue score ranges from 0 to 52 and is the sum of non-missing item scores; divided by the number of non-missing items, then multiplied by 13. If more than 6 items were missing, the total score was missing.|Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
118257|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 24|MOS: participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
118258|NCT00663052|Other Pre-specified|Mean Medical Outcomes Study (MOS) Sleep Scale Scores at Week 12|MOS scale has 12 questions to assess sleep quality & quantity: 1)time to fall asleep, 2)hours of sleep/night in past 4 weeks,3)sleep not peaceful, 4)got enough sleep to feel rested in morning,5)awaken short of breath/headache 6)feel drowsy in day,7)trouble going to sleep, 8)wake up during sleep; trouble going back to sleep,9)trouble staying awake in day, 10)Snoring,11)take naps in day,12)get amount of sleep needed. Sleep problem index(SPI) I:mean of 4,5,7,8,9,12; SPI II:mean of 1,3,4,5,6,7,8,9,12. All reported responses are on scale:0-100, higher scores indicate greater intensity of attribute.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
118259|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 24|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 24|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.||Percentage of indicated parameter||Standard Deviation|Mean
118260|NCT00663052|Other Pre-specified|Work Productivity and Activity Impairment: Psoriasis (WPAI:PSO) at Week 12|WPAI:PSO - participant rated questionnaire to assess effect of psoriasis on ability to work and perform regular activities in 4 areas: percent activity impairment (0 [no effect on daily activities] to 100 [psoriasis completely prevented from doing daily activities]), percent impairment while working (0 [no effect] to 100 [completely prevented from working]); percent work time missed due to psoriasis, and percent overall work impairment (0 [no effect] to 100 [completely prevented from working]).|Week 12|mITT population: all randomized participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had missing values at any time point, LOCF method of imputation used. 'n' signifies participants evaluated for this measure at each timepoint, for each group respectively.||Percentage of indicated parameter||Standard Deviation|Mean
118261|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Depression Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118392|NCT00662389|Primary|Serious Adverse Events|Number of Serious Adverse Events|Immediate|||Number of Serious Adverse Events|||Number
125619|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Sensory Perception’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
118262|NCT00663052|Other Pre-specified|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) - Anxiety Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118263|NCT00663052|Other Pre-specified|Change From Baseline in the Euro Quality of Life 5 Dimension (EQ-5D) Utility Index|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (example confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline, Week 12 and Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118264|NCT00663052|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118265|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Primary Psoriasis Treatment According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
118266|NCT00663052|Other Pre-specified|Percentage of Participants Who Were Considered Satisfied With Health State According to Psoriasis Subject Satisfaction Questionnaire (PSSQ)|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) with Yes/No answers are summarized here.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
118267|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 24|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 (never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
118268|NCT00663052|Secondary|Mean Psoriasis Subject Satisfaction Questionnaire (PSSQ) Scores at Week 12|PSSQ: participant’s assessment that includes 18 items, 16 items (1-16) scored using Likert score with scores from 0 (very dissatisfied) to 4 (very satisfied) and 5 ( never had this problem). Only those participants who do not have score of 5 at baseline included in the item 1-16 analyses. Two items (17, 18) are with Yes/No answers. The scores of items 1-16 for change from baseline are summarized here.|Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Deviation|Mean
118269|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated by Physicians Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Primary Psoriasis Therapy Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) includes two global satisfaction questions to which physicians respond either ‘satisfactory’ or ‘not satisfactory.’ These are: 1) whether the participant’s current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant’s current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
118353|NCT00662818|Secondary|Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose|Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events.|Up to 48 hours after the dose of any study medication (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.||Participants|||Number
118270|NCT00663052|Other Pre-specified|Percentage of Participants Evaluated Using Psoriasis Physician Satisfaction Questionnaire (PPSQ): Consider Patient's Condition Satisfactory From Baseline at Each Visit Through Week 24|Physician Psoriasis Satisfaction Questionnaire (PPSQ) included two global satisfaction questions to which physicians respond either ‘satisfactory’ or ‘not satisfactory.’ These are: 1) whether the participant’s current condition is satisfactory, considering psoriasis symptoms, skin appearance and all other problems that psoriasis causes; 2) whether the participant’s current primary psoriasis therapy is satisfactory, considering psoriasis symptoms, skin appearance, therapy side effects and therapy ease/difficulty of use. Each of these questions was summarized for change from baseline.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
118271|NCT00663052|Other Pre-specified|Change From Baseline in Psoriatic Arthritis Screening and Evaluation (PASE) Total Score at Week 12|PASE a participant-administered questionnaire and a simple scoring system to assist physicians in screening participants with psoriasis for evidence of psoriatic arthritis with two sub-scales: system sub-scale and function sub-scale. Total of 15 questions in both sub-scales (7 questions in system and 8 in function sub-scale) to score from 1 to 5; where 1 = strongly disagree and 5 = strongly agree. The total of system and function scores provides the total PASE score ranging from 15 to 75 where higher scores indicate greater severity.|Baseline, Week 12|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118272|NCT00663052|Secondary|Percentage of Participants Not Using Topical Preparations at Each Visit From Week 12 Through Week 24|Moderate topical steroids to very potent topical steroids, topical vitamin D analogs, topical steroids in combination with vitamin D analogs, and anthralin compounds were prohibited for 14 days before the baseline visit until week 12.|From Week 12 to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
118273|NCT00663052|Secondary|Change From Baseline in the Photographed Image of Lesions in Selected Participants|Compare the before and after photographs with the clinical assessments (Psoriasis Area and Severity Index, Physician's Global Assessment) taken at the same time for illustration purposes. Measured as yes or no for change.|Baseline to Week 24|The data was not collected as planned.||Units on scale|||Number
118274|NCT00663052|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Each Visit Through Week 24||Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of BSA||Standard Deviation|Mean
118275|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Psoriasis at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of psoriasis disease activity at a scale of 0 to 5; where 0 = good and 5 = severe.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118276|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Each Visit Through Week 24|SGA of Joint Pain: score based on participant's assessment of joint pain at a scale of 0 to 5; where 0 = no pain and 5 = severe pain.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118277|NCT00663052|Other Pre-specified|Change From Baseline in Subject Global Assessment (SGA) of Itching at Each Visit Through Week 24|SGA of Psoriasis: score based on participant's assessment of itching at a scale of 0 to 5; where 0 = no itching and 5 = severe itching.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118278|NCT00663052|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118279|NCT00663052|Secondary|Time to First Physician Global Assessment (PGA) of Psoriasis of Clear/Almost Clear (0, 1), or Clear/Almost Clear/Mild (0, 1, 2) Over 24 Weeks|Time taken to achieve PGA was calculated using Kaplan-Meier estimate and presented as median. Assessment of clear or almost clear or Mild = PGA score of 0 (no evidence) or 1 (minimal/faint) or 2 (mild plaque elevation, mild fine scales predominates or light red coloration).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. OC analyses were performed including only those participants who were evaluated at the specified visits.||Days||95% Confidence Interval|Median
118329|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax||0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).||min||Full Range|Median
118280|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear/Almost Clear/Mild (0, 1, 2) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear and 2 = Mild.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
118281|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses Clear/Almost Clear (0, 1) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear; 1 = Almost Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
118282|NCT00663052|Secondary|Percentage of Participants Achieving the Physician Global Assessment (PGA) of Psoriasis Responses of Clear (0) at Each Visit Through Week 24|PGA of Psoriasis: score based on dermatologist's assessment of head, scalp, and neck psoriasis (averaged over all lesions). The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). PGA score of 0 = Status of Clear.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
118283|NCT00663052|Secondary|Time to Achieve Psoriasis Area and Severity Index (PASI) 50, PASI 75 and PASI 100 Over 24 Weeks|Time taken to achieve first PASI was calculated using Kaplan-Meier estimate and presented as median. PASI 50=50% improvement from baseline in PASI; PASI 75=75% improvement from baseline in PASI; PASI 90=90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI. PASI score percent improvement =100*(baseline score - visit score)/baseline score.|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. Observed cases (OC) analyses were performed including only those participants who were evaluated at the specified visits.||Days||95% Confidence Interval|Median
118284|NCT00663052|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores were combined for final PASI. For each section, percent area of skin involved estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Units on scale||Standard Error|Mean
118285|NCT00663052|Secondary|Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants||95% Confidence Interval|Number
118286|NCT00663052|Secondary|Percentage of Participants Achieving a 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
118287|NCT00663052|Secondary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
118340|NCT00662831|Secondary|Median Time to First Amputation||Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||months||95% Confidence Interval|Median
118288|NCT00663052|Secondary|Percentage of Participants Achieving a 50% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Each Visit Through Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline to Week 24|mITT population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the LOCF method of imputation was used.||Percentage of participants|||Number
118289|NCT00663052|Primary|Percentage of Participants Achieving a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 24|PASI: Combined assessment of lesion severity and area affected into single score; range: 0(no disease) to 72(maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent-to-treat (mITT) population: all randomly assigned participants who received at least 1 ETN dose and had both baseline and on-therapy PASI evaluations. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||Percentage of participants|||Number
118290|NCT00663026|Secondary|Apparent Systemic Clearance (CL/F)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction (F) of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state apparent systemic clearance (CL/F) was calculated as dose/AUC tau.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||milliliter/hour/kilogram (mL/hr/kg)||Standard Deviation|Mean
118291|NCT00663026|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the serum concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
118292|NCT00663026|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F).||hours||Full Range|Median
118293|NCT00663026|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|t1/2 not calculated due to inadequate characterization of the terminal elimination phase.|||||
118294|NCT00663026|Secondary|Average Serum Concentration at Steady State (Cavg,ss)|Average plasma concentration at steady state (Cavg,ss) = AUCtau divided by dosing interval (1 week). AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 1 week.|Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|PK analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, tmax, AUC, t1/2, CL/F and Vz/F). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
118295|NCT00663026|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12|Pharmacokinetic (PK) analysis set included all participants who provided data for the estimation of at least 1 of the relevant PK parameters (Cmax, time to maximum concentration [tmax], area under the curve [AUC], terminal elimination half-life [t1/2], apparent systemic clearance [CL/F], and apparent volume of distribution [Vz/F]).||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
118296|NCT00663026|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after Week 25 dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after Week 25 dose|Safety population included all randomized participants who received at least 1 dose of study medication.||participants|||Number
118341|NCT00662831|Secondary|Time to Intact Skin Healing|Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||months||95% Confidence Interval|Median
118297|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
118298|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
118299|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
118300|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
118301|NCT00662909|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.||participants|||Number
118302|NCT00662909|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1 point improvement from Baseline to post-baseline and a major improvement was defined as at least a 2 point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Percentage of participants|||Number
118303|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician's office during the 4 weeks prior to each study visit (excluding study visits) because of the patient's bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Physician visits||Standard Deviation|Mean
118304|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled ‘No, not at all’ on the left (=0) to ‘Yes, completely satisfied’ on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
118305|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Error|Least Squares Mean
118306|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||Scores on a scale||Standard Deviation|Mean
118307|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.||percent activity impairment||Standard Deviation|Mean
118308|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent overall work impairment||Standard Deviation|Mean
118309|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent impairment while working||Standard Deviation|Mean
118310|NCT00662909|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.||percent work time missed||Standard Deviation|Mean
118311|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.||Scores on a scale||Standard Error|Least Squares Mean
118441|NCT00661778|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 4 years)||||||
118312|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.||Scores on a scale||Standard Error|Least Squares Mean
118313|NCT00662909|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Percentage of participants|||Number
118314|NCT00662909|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Percentage of participants|||Number
118315|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.||pads||Standard Error|Least Squares Mean
118316|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis.~N is the number of participants included at each time point."||Nocturia episodes||Standard Error|Least Squares Mean
118317|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as “N”.||Scores on a scale||Standard Error|Least Squares Mean
118318|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.||Urgency episodes||Standard Error|Least Squares Mean
118319|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 post baseline micturition measurement in the visit diary & at least 1 urgency incontinence episode at baseline. LOCF was used for the Final Visit analysis. N = the number of patients included at each time point.||Urgency incontinence episodes||Standard Error|Least Squares Mean
118320|NCT00662909|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as “N”.||mL||Standard Error|Least Squares Mean
118321|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not used in this analysis. The number of patients included in the calculation for each time point is noted as “N”.||Micturitions||Standard Error|Least Squares Mean
118322|NCT00662909|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.||Incontinence episodes||Standard Error|Least Squares Mean
118323|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not used in this analysis.||Micturitions||Standard Error|Least Squares Mean
118324|NCT00662909|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward was not used in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
118325|NCT00662909|Secondary|Change From Baseline to Final Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.||mL||Standard Error|Least Squares Mean
118326|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was used in this analysis.||Micturitions||Standard Error|Least Squares Mean
118327|NCT00662909|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12 (Final Visit)|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was used in this analysis.||Incontinence episodes||Standard Error|Least Squares Mean
118328|NCT00662857|Primary|Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro|Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)|0 to 360 minutes post-dose|"Rapid-acting insulin Analogue (RAA) Population~All subjects who had serum insulin concentration data for both TI Inhalation Powder B and insulin lispro and were deemed to be protocol compliant (no major protocol violations during the clinical trial)."||(micro U)*min/mL||Standard Error|Least Squares Mean
118330|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.|Maximum observed baseline-corrected serum insulin concentration|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).||(micro U)/mL||Standard Error|Least Squares Mean
118331|NCT00662857|Primary|Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360|Dose-normalized baseline-corrected area under the serum insulin vs. time curve|0 to 360 minutes post-dose|Per Protocol Population - All subjects who completed the crossover portion of the trial (through Visit 3), had serum insulin concentration data for both TI Inhalation Powder A and TI Inhalation Powder B and were deemed to be protocol compliant (no major protocol violations during the clinical trial).||(micro U)*min/mL||Standard Error|Least Squares Mean
118332|NCT00662831|Other Pre-specified|Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||hemorrhages|||Number
118333|NCT00662831|Other Pre-specified|Number of Major and Minor Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||hemorrhages|||Number
118334|NCT00662831|Other Pre-specified|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Week 24 (EOT) or early termination|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.||hemorrhages|||Number
118335|NCT00662831|Secondary|Transcutaneous Local Tissue Oxygenation (pO2)|Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were analyzed at selected sites only, based on availability. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
118336|NCT00662831|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant’s pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
118337|NCT00662831|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
118338|NCT00662831|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||mm||Standard Deviation|Mean
118339|NCT00662831|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 24 (EOT or early termination)|ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
118342|NCT00662831|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Week 24 (EOT) or early termination|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.||participants|||Number
118343|NCT00662831|Secondary|Number of Participants Who Died||Week 24 (EOT) or early termination|ITT population included all participants who were randomized.||participants|||Number
118344|NCT00662831|Secondary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||participants|||Number
118345|NCT00662831|Secondary|Number of Participants Who Underwent Major and Minor Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.||participants|||Number
118346|NCT00662831|Secondary|Number of Participants Who Underwent Any Amputation|Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized.||participants|||Number
118347|NCT00662831|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 (EOT) or early termination|ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||participants|||Number
118348|NCT00662831|Primary|Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing|University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.|Week 24 [end of treatment (EOT)] or early termination|Intention to treat (ITT) population included all participants who were randomized. Last observation carried forward (LOCF) method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||participants|||Number
118349|NCT00662818|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose|SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|Up to 24 hours post-dose (Up to 14 weeks)|The FAS population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.||Percentage of Participants||95% Confidence Interval|Number
118350|NCT00662818|Secondary|Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for nausea prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.||Percentage of Participants||95% Confidence Interval|Number
118351|NCT00662818|Secondary|Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 Hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for photophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.||Percentage of Participants||95% Confidence Interval|Number
118352|NCT00662818|Secondary|Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose (Up to 6 weeks)|The FAS population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for phonophobia prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.||Percentage of participants||95% Confidence Interval|Number
125620|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Involuntary Movements’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
118354|NCT00662818|Primary|Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 48 hours post-dose (Up to 14 weeks)|The APaT Population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.||Participants|||Number
118355|NCT00662818|Primary|Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Within 14 days of any dose of study medication (Up to 16 weeks)|All-Patients-as-Treated (APaT) population consisted of all participants who received at least 1 dose of study medication were included in the treatment group according to the medication actually received.||Participants|||Number
118356|NCT00662818|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of Participants||95% Confidence Interval|Number
118357|NCT00662818|Primary|Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)|Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose (Up to 6 weeks)|The full-analysis set (FAS) included participants treated for a migraine attack. Participants had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants||95% Confidence Interval|Number
118358|NCT00662675|Secondary|Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase|Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase.|Entire 7 days double-blind phase|ITT||Percent of participants|||Number
118359|NCT00662675|Secondary|Change in Percent COA-Protein (Nitrogen)|The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|ITT||percentage COA-protein||Standard Deviation|Mean
118360|NCT00662675|Primary|Change in the Coefficient of Fat Absorption (COA-fat Percent)|Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase.|72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase.|Intent-to-Treat (ITT)||percentage COA-fat||Standard Deviation|Mean
118361|NCT00662649|Secondary|Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression|Kurtzke’s Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.|Core baseline to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.||Percentage of patients||95% Confidence Interval|Number
118362|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0 to end of study (maximum up to 60 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. This analysis included only patients with value at both core baseline and end of study.||Percent change||Standard Deviation|Mean
118363|NCT00662649|Primary|Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.||Ratio of relapses per year||95% Confidence Interval|Number
118390|NCT00662532|Secondary|Initial PD Reduction|Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject|Baseline to Day 90|||mm||Standard Deviation|Mean
118364|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.||Relapses per year||95% Confidence Interval|Number
118365|NCT00662649|Secondary|Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.||Percent change||Standard Deviation|Mean
118366|NCT00662649|Secondary|Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.||Percentage of patients|||Number
118367|NCT00662649|Primary|Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free|A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.|Core baseline to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.||Percentage of patients||95% Confidence Interval|Number
118368|NCT00662649|Secondary|Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)|The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Months 0-24 (core study) and Months 24-48 (extension study)|Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.||Lesions||Standard Deviation|Mean
118369|NCT00662649|Primary|Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)|ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Months 0 to end of study (maximum up to 60 months)|Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.||Relapses per year||95% Confidence Interval|Number
118370|NCT00662558|Secondary|Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ|Subjects were successful responders if they had: > = 30% improvement from baseline to final visit in VAS assessment (as identified by 100 millimeter scale); > = 30% improvement from baseline to final visit in Patient's Global assessment (classified as improved if assessment reduced at least 2 grades from baseline or if assessment changed to Grade 1, worsened if assessment increased at least 2 grades from baseline or if assessment changed to Grade 5, or no change; and < 20% worsening from baseline to final visit in RMDQ assessment (lower scores indicated greater disability).|Week 6/ET|ITT||participants|||Number
118371|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with walking and bending ability scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.||participants|||Number
118372|NCT00662558|Secondary|Patient's Satisfaction Questionnaire (With Pain Relief Scale)|Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).|Week 6/ET|ITT. Number of subjects with Patient's Satisfaction Questionnaire (with pain relief scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.||participants|||Number
118373|NCT00662558|Secondary|Patient's Global Evaluation of Study Medication|Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.|Weeks 1, 3, and 6/ET|ITT.||participants|||Number
118374|NCT00662558|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ)|The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.|Baseline, Week 6/ET|ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.||scores on a scale||Standard Error|Mean
118375|NCT00662558|Secondary|Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores|The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.|Baseline, Week 6/ET|ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365.||participants|||Number
118376|NCT00662558|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale|MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.||scores on a scale||Standard Error|Mean
118377|NCT00662558|Secondary|Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)|m-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with m-BPI-sf scores at Baseline and Week 6/ET: celecoxib n=373, tramadol HCl n=367.||scores on a scale||Standard Error|Mean
118378|NCT00662558|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with Roland-Morris Disability total scores at Baseline and Week 6/ET= celecoxib n=391, tramadol n=389.||scores on a scale||Standard Error|Mean
118379|NCT00662558|Secondary|Physician's Global Assessment of Disease Activity|"Number of subjects with a physician's grading of disease activity using the Physician’s Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361.||participants|||Number
118380|NCT00662558|Secondary|Patient's Global Assessment of Disease Activity|"Number of subjects with a graded level of disease activity using the Patient’s Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as Improved if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as Worsened if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as No Change otherwise."|Week 6/ET|ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367.||participants|||Number
118381|NCT00662558|Secondary|Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)|VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, “During the past day, how much back pain did you have?”, the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with VAS scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.||mm||Standard Error|Mean
118382|NCT00662558|Secondary|Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.|Baseline, Week 6/ET|ITT. Missing values were imputed by LOCF. Number of subjects with NRS-Pain scale scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.||scores on a scale||Standard Error|Mean
118383|NCT00662558|Primary|Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)|A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).|Week 6 or Early Termination (ET)|Intent-to-treat = all subjects who were randomized and received at least one dose of study medication. Missing values were imputed using last observation carried forward (LOCF).||participants|||Number
118384|NCT00662545|Secondary|HIV RNA < 75 Copies/ml||entry, week 12, and week 24|||participants|||Number
118385|NCT00662545|Secondary|Incidence of ALT Flares|ALT flare: sudden increase in blood level of alanine transaminase (ALT)|every 4 weeks for 24 weeks|||participants|||Number
118386|NCT00662545|Secondary|Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)||every 4 weeks for 24 weeks|||participants|||Number
118387|NCT00662545|Secondary|Incidence of Permanent Discontinuation Due to Toxicity||24 weeks|||participants|||Number
118388|NCT00662545|Primary|Hepatitis B Virus (HBV) DNA|HBV DNA carries the genetic blueprint of the virus. How many HBV DNA “particles” or “copies” are found in the blood indicates how rapidly the virus is reproducing in the liver.|week 24|||log 10 IU/ml||Full Range|Median
118389|NCT00662532|Secondary|BOP Percent Reduction From Baseline|Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline|at Day 90 and Day 180|ITT||Percentage of Participants||Standard Deviation|Least Squares Mean
118393|NCT00662363|Primary|Change in Patient Assessment of Constipation - Quality of Life|The second component of the PAC is the quality of life (QOL) component.The quality of life (QOL) component consists of five items that are rated on a 0-4 scale with higher scores indicating better QOL. Scores within the domains are averaged.|Baseline and day 7|intention to treat||units on a scale||Standard Deviation|Mean
118394|NCT00662363|Primary|Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)|Patient Assessment of Constipation (PAC) – Change in this measure was assessed. The PAC has previously been found to be a valid and reliable way to measure constipation symptoms and clinical course. The PAC has two components. The symptom (SYM) component is composed of 12 items with score range 0-4 with lower scores indicating improvement. Scores within the two domains were separately averaged. The PAC-SYM questionnaire has shown good concurrent and clinical validity for opioid-induced constipation in a number of pain populations and has demonstrative responsiveness to treatment. There are three symptom domains within the PAC-SYM: Abdominal symptoms (4 items), rectal symptoms (3 items) and stool symptoms (5 items).|Baseline and Day 7, after treatment completed (6 days of treatment)|All subjects randomized and who had baseline and endpoint data were included in the intention to treat analysis.||units on a scale||Standard Deviation|Mean
118395|NCT00662207|Primary|Number of Participants With a Urethral Sphincter Contractions||3 hour recording session|||participants|||Number
118396|NCT00662207|Primary|Number of Participants With a Change in Anal Sphincter Pressure|Measured via balloon catheter|3 hour recording session|||participants|||Number
118397|NCT00662207|Primary|Number of Participants With a Change in External Urethral Pressure|Measured via balloon catheter|3 hour recording session|||participants|||Number
118398|NCT00662207|Primary|Number of Participants With a Change in Bladder Pressure|Measured via pressure catheter in bladder with a pressure transducer|3 hour recording session|||participants|||Number
118399|NCT00662025|Secondary|t1/2 for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|t1/2 means a terminal phase half-life. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).~n=Number of participants with analyzable data."||hours||Standard Deviation|Mean
118400|NCT00662025|Secondary|AUC(0-inf) for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"AUC(0-inf) means an area under the plasma concentration time curve from time zero to Infinity.~5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants(Cohort 1).~n=Number of participants with analyzable data."||nanogram∙hour/milliliter||Standard Deviation|Mean
118401|NCT00662025|Secondary|Cmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|Cmax means a maximum observed plasma concentration. 5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil|Day 14 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 subjects (Cohort 1). n=Number of subjects with analyzable data.||nanogram/milliliter||Standard Deviation|Mean
118402|NCT00662025|Secondary|Tmax for Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR and 5-FU)|"Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).~5'-DFCR = 5'-deoxy-5-fluorocytidine, 5'-DFUR = 5'-deoxy-5-fluorouridine, 5-FU = 5-fluorouracil"|Day 14 of Cycle 1|"Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).~n=Number of participants with analyzable data."||hours||Full Range|Median
118403|NCT00662025|Secondary|AUC(0-24) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. AUC(0-24) means an area under the plasma concentration time curve from time zero to 24 hours post-dose.~The AUC(0-24) for total drug (sunitinib+SU012662) was calculated as the mean of the AUC(0-24) of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||nanogram∙hour/milliliter||Standard Deviation|Mean
118404|NCT00662025|Secondary|Cmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Cmax means a maximum observed plasma concentration.~The Cmax for total drug (sunitinib+SU012662) was calculated as the mean of the Cmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||nanogram/milliliter||Standard Deviation|Mean
118405|NCT00662025|Secondary|Tmax for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Tmax means a time to first occurrence of maximum observed plasma concentration (Cmax).~The Tmax for total drug (sunitinib+SU012662) was calculated as the median of the Tmax of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||hours||Full Range|Median
118406|NCT00662025|Secondary|Trough Plasma Concentration (Ctrough) for Sunitinib, SU012662, and Total Drug (Sunitinib+SU012662)|"SU012662 is a metabolite of sunitinib. Trough plasma concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (sunitinib+SU012662) was calculated as the mean of the Ctrough of total drug from individual participant."|Days 14 and 15 of Cycle 1|Pharmacokinetic parameters are estimated for the initial 6 participants (Cohort 1).||nanogram/milliliter||Standard Deviation|Mean
118407|NCT00662025|Secondary|Overall Survival (OS)|OS is defined as the time from the start of study treatment to death due to any cause. OS data is censored on the last day they were known to be alive in the absence of confirmation of death.|A survival survey was conducted at least every 6 months after the completion of study treatment or withdrawal from the study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||months||Full Range|Median
118408|NCT00662025|Secondary|Time to Objective Tumor Response (TTR)|Based on Data Review Committee's Assessment. TTR is defined as the time from the start of study treatment to first documentation of objective tumor response (confirmed CR or PR). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.~Twenty three participants with objective tumor response were analyzed for TTR."||months||95% Confidence Interval|Median
118409|NCT00662025|Secondary|Duration of Objective Tumor Response (DR)|Based on Data Review Committee's Assessment. DR is defined as the time from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or to death due to cancer, whichever occurred first. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|"FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.~Nineteen participants with objective tumor response were analyzed for DR."||months||95% Confidence Interval|Median
118410|NCT00662025|Secondary|Time to Tumor Progression (TTP)|Based on Data Review Committee's Assessment. TTP is defined as the time from the start of study treatment to first documentation of objective tumor progression.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all enrolled patients who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||months||95% Confidence Interval|Median
118411|NCT00662025|Secondary|Progression-Free Survival (PFS)|Based on Data Review Committee's Assessment. PFS is defined as the time from the start of study treatment to first documentation of objective tumor progression, or to death on study due to any cause, whichever occurred first.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||months||95% Confidence Interval|Median
118412|NCT00662025|Secondary|Number of Subjects With CBR Based on Investigator's Assessment|Number of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
118413|NCT00662025|Secondary|Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment|Number of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as a reference the baseline sum LD according to RECIST. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of LDs since treatment started.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
118414|NCT00662025|Secondary|Number of Participants With Objective Response Based on Investigator's Assessment|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the LDs of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.|FAS is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
118415|NCT00662025|Primary|Number of Participants With Objective Response Based on Data Review Committee's Assessment|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.|Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.|Full Analysis Set (FAS) is defined as the population of all participants who are diagnosed as having advanced/metastatic breast cancer and received at least one dose of study medication.||participants|||Number
118416|NCT00661999|Secondary|Transferrin Saturation at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks|||Percentage Saturation||Standard Deviation|Mean
118417|NCT00661999|Secondary|Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16|MCV is a measure of the average red blood cell volume.|Baseline, 7 weeks and 16 weeks|||fL||Standard Deviation|Mean
118418|NCT00661999|Secondary|Ferritin Level at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks|||µg/L||Standard Deviation|Mean
118419|NCT00661999|Secondary|Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16||1 week, 7 weeks and 16 weeks|||mg/L||Standard Deviation|Mean
118420|NCT00661999|Secondary|C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16||1 Week, 7 Weeks and 16 Weeks|||mg/L||Standard Deviation|Mean
118421|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by The Functional Assessment of Cancer Therapy-Anemia (FACT-An) at End of Study|FACT-AN Scale range: 0 (Worst) to 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
118422|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Brief Fatigue Inventory(BFI) Fatigue Now Scale at End of Study|Fatigue Now Scale range: 0 (No Fatigue) to 10 (Worst), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
118423|NCT00661999|Secondary|Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study|SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
118424|NCT00661999|Secondary|Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)|Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.|Baseline and 16 weeks|||Scores on a scale||Standard Deviation|Mean
118425|NCT00661999|Secondary|Time to First Red Blood Cell (RBC) Transfusions||16 weeks|Only 63 participants (20 DA + IV Iron, 21 DA + Oral Iron and 22 DA + Placebo) needed RBC transfusion during 16 weeks of treatment period. Thus, median of time to first RBC transfusion and 95 % confidence interval are not attainable.||Days||95% Confidence Interval|Median
118426|NCT00661999|Secondary|Time to Hematopoietic Response|Hematopoietic response was defined as Hb increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 weeks|||Days||95% Confidence Interval|Median
118427|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 16|Value at 16 weeks minus value at baseline.|Baseline and 16 weeks|||g/dL||Standard Deviation|Mean
118428|NCT00661999|Secondary|Mean Increment in Hemoglobin Level at Week 7|Value at 7 weeks minus value at baseline.|Baseline and 7 weeks|||g/dL||Standard Deviation|Mean
118429|NCT00661999|Secondary|Incidence of Patients Receiving at Least One Red Blood Cell (RBC) Transfusions||Week 1 to Week 16|||Participants|||Number
118430|NCT00661999|Secondary|Percentage of Patients Maintaining an Average Hemoglobin Level Within the National Comprehensive Cancer Network (NCCN) Range (11-13 g/dL) Through Week 16, Once Achieving a Hemoglobin of ≥ 11 g/dL||16 Weeks|||Percentage of Participants|||Number
118431|NCT00661999|Primary|Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response|Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb >= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.|16 Weeks|||Participants|||Number
118432|NCT00661960|Primary|the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.|Duodenal tissue immune cell subsets were measured by flow cytometry.|nine months|all subjects who completed all study visits||% CD3/CD4 T-cells in GALT tissue||Inter-Quartile Range|Median
118433|NCT00661895|Secondary|New Onset Diabetes Mellitus||3 month intervals||||||
118434|NCT00661895|Primary|Percentage of Subjects Achieving Blood Pressure Goals|Percentage of subjects who achieved JNC-VII defined blood pressure goals.|3 month intervals|||percentage of participants|||Number
118435|NCT00661830|Secondary|Time to Objective Response|Time to Objective Response (OR) is defined as the time from start of treatment to objective tumor response (CR or PR) is first documented according to the RECIST tumor response criteria during treatment or until 30 days after termination of active therapy. Response must subsequently be confirmed. For subjects failing to achieve an objective response and who did not progress during the trial, time to objective response will be censored at their last date of tumor evaluation.|one year|All subjects who receive at least one dose of trial treatment and had no progression during the trial are included in the analysis||days||95% Confidence Interval|Median
118436|NCT00661830|Secondary|Best Overall Response|"Best Overall Response (BOR) is defined as the best tumor response (confirmed partial or complete response, stable disease) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. Best response is determined from the sequence of responses assessed. For complete response (CR) or partial response (PR), best response must be confirmed by a second assessment within 4 -6 weeks.~Two objective status determinations of CR before progression are required for a best response of CR.~Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR.~Best response of Stable Disease (SD) is defined as disease that does not meet the criteria of CR, PR or Progressive Disease (PD) and has been evaluated at least one time, at least 6 weeks after baseline assessment."|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.||participants|||Number
118437|NCT00661830|Secondary|Overall Survival|Overall Survival (OS) is measured from start of treatment to death due to any cause until end of follow-up period. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored at the date of the last observation.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis||days||95% Confidence Interval|Median
118438|NCT00661830|Primary|Progression-free Survival (PFS)|The primary endpoint is the progression-free survival (PFS) defined as the time from start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first during treatment or follow-up period. For patients not known to have died as of the data cut-off date and who do not have objective progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation anti-cancer therapy. Acceptable documentation of objective disease progression status consists of objective assessments using CT scan assessment method.|one year|All subjects who receive at least one dose of trial treatment are included in the analysis.||days||95% Confidence Interval|Median
118439|NCT00661778|Secondary|1-year Survival|The probability of surviving 1 year was estimated using the Kaplan-Meier method.|Baseline to 1 year|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.||Percentage of participants||95% Confidence Interval|Number
118440|NCT00661778|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.||Months||95% Confidence Interval|Median
118442|NCT00661778|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 4 years)|Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations.||Percentage of participants|||Number
118443|NCT00661778|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 4 years)|Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.||Months||95% Confidence Interval|Median
118444|NCT00661726|Primary|Change in Total Hemoglobin (Hb) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||g/dL||Standard Error|Mean
118445|NCT00661726|Secondary|Change in Percentage of Annexin-positive Cells From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||% of Annexin-Positive Cells||Standard Error|Mean
118446|NCT00661726|Secondary|Change in Percentage of Red Blood Cell (RBC) Hb Concentration From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||% of RBC Hb Concentration||Standard Error|Mean
118447|NCT00661726|Secondary|Change in Red Blood Cell (RBC) Deformability From Baseline to Peak (the Follow-up Time Point With the Highest Value)|Deformability was assessed by ektacytometry. Normal RBC have maximal deformability, measurable by osmotic ektacytometry, at isotonicity (290 mosmol). A decrease on the Deformability Index (measured in arbitrary units) corresponds to an impairment in the cell membrane’s ability to alter its shape under stress.|up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||Arbitrary Units||Standard Error|Mean
118448|NCT00661726|Secondary|Change in Neutrophil Counts From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||X (10^9)/L||Standard Error|Mean
118449|NCT00661726|Secondary|Change in Platelet Count From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||X (10^9)/L||Standard Error|Mean
118450|NCT00661726|Secondary|Change in Erythropoietin Levels From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||mIU/mL||Standard Error|Mean
118451|NCT00661726|Secondary|Change in Absolute Reticulocyte Count From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||X (10^9)/L||Standard Error|Mean
118452|NCT00661726|Secondary|Change in Serum Lactate Dehydrogenase (LDH) From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||U/L||Standard Error|Mean
118453|NCT00661726|Secondary|Change in Indirect Bilirubin From Baseline to Nadir (the Follow-up Time Point With the Lowest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||µmol/L||Standard Error|Mean
118454|NCT00661726|Primary|Number of Evaluable Patients With an Increase From Baseline in Hemoglobin (Hb) of ≥1.5 g/dL||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||participants|||Number
118455|NCT00661726|Secondary|Change in Absolute Fetal Hemoglobin (HbF) From Baseline to Peak (the Follow-up Time Point With the Highest Value)||up to 12 weeks|One of 6 enrolled patients withdrew from study after week 2 and was not used for analysis.||g/dL||Standard Error|Mean
118456|NCT00661713|Secondary|Number of Subjects Reporting Unsolicited AEs Throughout the Study.|Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.|Throughout the study|Analysis was performed as per the safety dataset.||participants|||Number
118457|NCT00661713|Secondary|GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination|Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-953Antigen|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
118458|NCT00661713|Secondary|GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-953 Antigen.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||IU/ml||95% Confidence Interval|Geometric Mean
118459|NCT00661713|Secondary|Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
118460|NCT00661713|Secondary|Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.|month-1, month-2, month-3, month-6 and month-7|Analysis was performed as per the protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
118461|NCT00661713|Secondary|Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.|Month-1, month-2, month-3 and month-7|Analysis was performed as per the protocol dataset.||percentage of Subjects||95% Confidence Interval|Number
118462|NCT00661713|Secondary|Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titer ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains.|at baseline, month-1, month-2, month-3, month-6 and month-7.|Analysis was performed as per the protocol dataset.||percentage of Subjects||95% Confidence Interval|Number
118463|NCT00661713|Secondary|Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 agains 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.|Month-6 & 7|Analysis was performed as per the protocol dataset.||percentage of Subjects||95% Confidence Interval|Number
118464|NCT00661713|Primary|Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination|Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV|1 to 7 days after each vaccination|Analysis was performed as per the safety dataset.||participants|||Number
118465|NCT00661713|Primary|Percentages ‘of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.|Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.|Month-1, 2, 3|Analysis was performed as per the protocol dataset||percentage of Subjects||95% Confidence Interval|Number
118466|NCT00661687|Secondary|Lens Characteristics|Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.|Over all scheduled visits day 1 - 1 month|Over All Scheduled Visits, All Eligible, Dispensed Eyes||Eyes|Participants||Number
118467|NCT00661687|Secondary|LogMAR Visual Acuity|The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.|Mean over all visits - 1 day, 1 week, 1 month|All Eligible, Dispensed Eyes||LogMAR|Participants|Standard Deviation|Mean
118468|NCT00661687|Primary|Subjective Responses to Symptoms/Complaints|Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.|Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits|All eligible participants||Visual Analogue Scale|Participants|Standard Deviation|Mean
118469|NCT00661661|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to the last participants visit in the study. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for safety evaluation.|Baseline up to Week 288|Safety analysis set: all participants who received at least 1 dose of study medication in current study.||Particiants|||Number
118470|NCT00661661|Secondary|Change From Month 24 in Study A3921044 in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented potential improvement. Month 24 (the final visit) in Study A3921044 was taken as the first visit in current study.|First visit in the study (Month 24 in Study A3921044), Weeks 24, 48, and 96|Participants who had completed Study A3921044 among all participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118471|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Mental|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118472|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Component Score_Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118498|NCT00661609|Secondary|Progression Free Survival (PFS)|Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Weeks||Full Range|Median
118473|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118474|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Emotional|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118475|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Social Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118476|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Vitality|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118477|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_General Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118478|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Bodily Pain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118479|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Role Physical|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
125621|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Coordination/Balance’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
118480|NCT00661661|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Domain Score_Physical Functioning|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118481|NCT00661661|Secondary|Change From Baseline in Swollen Joint Counts|Sixty-six (66) joints, the same as those assessed for tenderness/pain except for the right and left hip joints, were assessed for swelling by palpation using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Swollen joints||Standard Error|Mean
118482|NCT00661661|Secondary|Change From Baseline in Tender/Painful Joint Counts|This was carried out on 68 joints. Each joint’s response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial joints). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Tender/painful joints||Standard Error|Mean
118483|NCT00661661|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118484|NCT00661661|Secondary|Change From Baseline in Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118485|NCT00661661|Secondary|Change From Baseline in Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS)."|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118486|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118487|NCT00661661|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118499|NCT00661609|Secondary|Duration of Objective Tumor Response (OTR)|Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)|Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)||||||
118538|NCT00661492|Secondary|Median Time to Prostate-specific Antigen (PSA) Progression|Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression.|24 months|Patients with Prostate-specific antigen (PSA) Information||Months||Full Range|Median
118488|NCT00661661|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Baseline, Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Units on a scale||Standard Error|Mean
118489|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Percentage of participants|||Number
118490|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Percentage of participants|||Number
118491|NCT00661661|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). The baseline data of Study A3921039, A3921040 or A3921044 were used as baseline data for efficacy evaluations except for Modified Total Sharp Score (mTSS).|Weeks 2, 4,8,12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288|Full analysis set (FAS): All participants who received at least 1 dose of study medication in current study. No imputation was used (observed data).||Percentage of participants|||Number
118492|NCT00661622|Secondary|Systemic Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression|||months||95% Confidence Interval|Median
118493|NCT00661622|Secondary|Median Progression Free Survival|"Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s)."|Baseline to time of progression|||months||95% Confidence Interval|Median
118494|NCT00661622|Secondary|Overall Survival|Measured from the start of the treatment to death of patients|Baseline to death|||months||95% Confidence Interval|Median
118495|NCT00661622|Primary|Overall Response Rate|Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.|Baseline then 3 to 4 weeks after every 2 treatments|||percentage of participants||90% Confidence Interval|Number
118496|NCT00661622|Primary|Response of Liver Metastases|"Complete response: Disappearance of all target and non-target liver lesions~Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions~Stable disease: Absence of change which would qualify as response or progression~Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s)"|Every 8 weeks|||participants|||Number
118497|NCT00661609|Secondary|Overall Survival (OS)|Time in weeks from the first administration of study drug to death.|Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Weeks||Full Range|Median
118534|NCT00661492|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|30 months|ITT population||months||Full Range|Median
118500|NCT00661609|Secondary|Disease Control Rate (DCR)|Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).|8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Percentage of participants|||Number
118501|NCT00661609|Primary|Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)|Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).|8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)|Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).||Percengate of participants|||Number
118502|NCT00661583|Secondary|Mean Change in Visual Acuity|Mean change in visual acuity in logMAR.|6 months|||logMAR||Full Range|Mean
118503|NCT00661583|Secondary|Mean Change in in Intraocular Pressure.|Mean change in in intraocular pressure at 3 months and at 6 months|6 months|||mmHg||Full Range|Mean
118504|NCT00661583|Secondary|Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.|To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications)|6 months|||percentage of subjects|||Number
118505|NCT00661583|Primary|Assessment of Ocular Adverse Events|To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months|6 months|||Number of Reported Adverse Events|||Number
118506|NCT00661570|Secondary|Reason for Replacement||At removal of prosthesis|1 patient had his Vega inappropriately removed and received a Provox2.||patients|||Number
118507|NCT00661570|Secondary|Ease of Insertion|The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.|assessed immediately after insertion procedure|All patients included for insertion evaluation||insertions|||Number
118508|NCT00661570|Secondary|Voice Quality|Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.|at 3 months or device change (whichever was first)|23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.||Units on a scale||Standard Deviation|Mean
118509|NCT00661570|Primary|Device Life Time|Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.|at replacement of voice prosthesis (maximum 1 year)|In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.||days of use||Full Range|Median
118510|NCT00661544|Primary|Response Rate|Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.|3, 6 and 12 months|||Participants|||Number
118511|NCT00661505|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period|Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.|Week 1 to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
118512|NCT00661505|Secondary|Number of Participants With Reports of Anti-erythropoietin Antibodies|The number of participants with Anti-epoetin antibodies is presented.|Up to Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
118513|NCT00661505|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
118514|NCT00661505|Secondary|Number of Participants Taking Concomitant Medications|The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.|Up to Week 28|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not.||Number of participants|||Number
118535|NCT00661492|Secondary|Median Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months|ITT population||months||Full Range|Median
118536|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Doubling Time|PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)]|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information||months||Full Range|Median
118515|NCT00661505|Secondary|Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.|Baseline (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Millimeters of Mercury||Standard Deviation|Mean
118516|NCT00661505|Secondary|Mean Change From Baseline in Weight at Week 16 and Week 24|Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||kilogram||Standard Deviation|Mean
118517|NCT00661505|Secondary|Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24|Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||millimole/liter||Standard Deviation|Mean
118518|NCT00661505|Secondary|Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24|Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||milligram/liter||Standard Deviation|Mean
118519|NCT00661505|Secondary|Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24|Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Percentage of TSAT||Standard Deviation|Mean
118520|NCT00661505|Secondary|Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24|Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||gram/liter||Standard Deviation|Mean
118521|NCT00661505|Secondary|Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24|Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||micromole/Liter||Standard Deviation|Mean
118522|NCT00661505|Secondary|Mean Change From Baseline in Ferritin at Week 16 and Week 24|Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||microgram/liter||Standard Deviation|Mean
118523|NCT00661505|Secondary|Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24|Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Number of cells x 10^9/L||Standard Deviation|Mean
118524|NCT00661505|Secondary|Mean Change From Baseline in Hemoglobin at Week 16 and Week 24|Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||g/dL||Standard Deviation|Mean
118537|NCT00661492|Secondary|Prostate-specific Antigen (PSA) Response Rate|Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later|24 months|Evaluable Population with Prostate-specific antigen (PSA) Information||percentage of participants||95% Confidence Interval|Number
118525|NCT00661505|Secondary|Mean Change From Baseline in Hematocrit at Week 16 and Week 24|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||percentage of red blood cells||Standard Deviation|Mean
118526|NCT00661505|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24|Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.|BL (Week -4 to Week 0), Week 16, and Week 24|The safety population included all participants who received at least one dose of C.E.R.A. and underwent a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Femtoliter||Standard Deviation|Mean
118527|NCT00661505|Secondary|Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least 1 dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||mcg||Standard Deviation|Mean
118528|NCT00661505|Secondary|Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis. n = number of participants with available data at the time of assessment.||Percentage of participants|||Number
118529|NCT00661505|Secondary|Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.|EEP (Week 16 to Week 20)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.||mcg||Standard Deviation|Mean
118530|NCT00661505|Secondary|Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period|The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available. Participants with available data at the time of assessment were included in the analysis.||days||Inter-Quartile Range|Median
118531|NCT00661505|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period|The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.|EEP (Week 16 to Week 24)|The ITT population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable was available.||Percentage of participants||95% Confidence Interval|Number
118532|NCT00661505|Secondary|Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period|The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|The Intention to treat (ITT) population included participants who received at least one dose of C.E.R.A. at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.||g/dL||Standard Deviation|Mean
118533|NCT00661505|Primary|Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period|The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.|EEP (Week 16 to Week 24)|The per protocol (PP) population included all participants who received at least one dose C.E.R.A. and underwent a safety follow-up except who had < 3 recorded Hb values and had inadequate iron status during EEP, missed C.E.R.A administration during Weeks 16-24, and/or who withdrawn before the end of EEP.||Percentage of participants||95% Confidence Interval|Number
118539|NCT00661492|Secondary|Objective Response Rate (ORR)|ORR = CR + PR Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|24 months|Patients with solid tumors||percentage of participants||95% Confidence Interval|Number
118540|NCT00661492|Secondary|2-year Radiographically Evident Progression-free Survival (REPFS).|"Radiographic progression:~1) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture)."|24 months.|Patients who received bone scans or had bone progression only (bone pain/pathologic fracture/palliative radiation).||Probability of REPFS at 2-year||95% Confidence Interval|Number
118541|NCT00661492|Primary|Median Time to Progression (TTP)|TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression.|24 months|ITT population||Months||Full Range|Median
118542|NCT00661479|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, Month 6|Safety Population: all patients treated on Day 1||Number of Letters Read Correctly||Standard Deviation|Mean
118543|NCT00661479|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 6|Safety Population: all patients treated on Day 1||Number of Letters Read Correctly||Standard Deviation|Mean
118544|NCT00661453|Secondary|Whole Body DEXA Scanning for Lean Body Mass and Total Bone Mineral Density/ Content||-2 weeks or time 0, 3 months, 6 months||||||
118545|NCT00661453|Secondary|Maximum Ulnar CMAP Amplitude/Area and MUNE||-2 weeks, time 0, 3 months, 6 months||||||
118546|NCT00661453|Secondary|Quantitative SMN mRNA and Protein Measures||-2 weeks, time 0 , 3 months, or 6 months||||||
118547|NCT00661453|Secondary|Functional Motor Assessments: TIMPSI Scores||-2 weeks, time 0, 3 months, 6 months||||||
118548|NCT00661453|Secondary|Primary Caregiver Functional Rating Scale for SMA Type I Subjects (PCFRS)||time 0, and monthly for 12 months||||||
118549|NCT00661453|Secondary|Time to Death or Ventilator Dependence (Defined as >16 Hours/Day)||monthly||||||
118550|NCT00661453|Primary|Anthropometric Measures of Nutritional Status (Body Mass Index [BMI] Z-scores, Weight for Length Ratios, Lean/Fat Mass Via DEXA, Growth Parameters, and Triceps Skinfold Measures)||-2 weeks, time 0, 3 months, 6 months|20 participants have baseline values, only 12 have 3 and 6 month values||g||Standard Deviation|Mean
118551|NCT00661453|Primary|Laboratory Safety Data||-2 weeks, + 2 weeks, 3 months, 6 months||||||
118552|NCT00661427|Secondary|Safety|Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.|at least weekly||||||
118553|NCT00661427|Primary|Evaluate Overall Objective Response Rate||Approximately every 8 weeks with imaging|||participants|||Number
118554|NCT00661388|Secondary|Mean Change From Baseline in Transferrin Saturation Over Time|Mean change from Baseline in transferrin saturation (TSAT) was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Percentage of Transferrin Saturation||Standard Deviation|Mean
118555|NCT00661388|Secondary|Mean Change From Baseline in Ferritin Concentration Over Time|Mean change from Baseline in ferritin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||mcg/L||Standard Deviation|Mean
118556|NCT00661388|Secondary|Mean Change From Baseline in Creatinine Concentration Over Time|Mean change from Baseline in creatinine concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 32, 40|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Micromole/L||Full Range|Median
118557|NCT00661388|Secondary|Mean Change From Baseline in Total Iron Binding Capacity and Iron Concentrations Over Time|Mean change from Baseline in total iron binding capacity (TIBC) and iron concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Micromole /L||Standard Deviation|Mean
118579|NCT00661193|Primary|Selection of One of Two Treatment Regimens (Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel) for Further Study in a Phase III Trial, Based on Median Progression-free Survival for ≥ 3 Months||From date of registration to 3 years or death, whichever comes first|||months||95% Confidence Interval|Median
125622|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Gait’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
118558|NCT00661388|Secondary|Mean Change From Baseline in Phosphate and Potassium Concentrations Over Time|Mean change from Baseline in phosphate and potassium concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Millimoles /L||Standard Deviation|Mean
118559|NCT00661388|Secondary|Mean Change From Baseline in C-Reactive Protein Concentration Over Time|Mean change from Baseline in C-Reactive Protein concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Milligrams /L||Standard Deviation|Mean
118560|NCT00661388|Secondary|Mean Change From Baseline in Albumin Concentration Over Time|Mean change from Baseline in albumin concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||g/L||Standard Deviation|Mean
118561|NCT00661388|Secondary|Mean Change From Baseline in White Blood Cells and Platelets Concentrations Over Time|Mean change from Baseline in white blood cells (WBCs) and platelets concentrations was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||10^9 cells/Liter (L)||Standard Deviation|Mean
118562|NCT00661388|Secondary|Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Over Time|Mean change from Baseline in erythrocyte mean corpuscular volume was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Femtoliters||Standard Deviation|Mean
118563|NCT00661388|Secondary|Mean Change From Baseline in Hematocrit Level Over Time|Mean change from Baseline in hematocrit level was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||Fraction||Standard Deviation|Mean
118564|NCT00661388|Secondary|Mean Change From Baseline in Hb Concentration Over Time|Mean change from Baseline in Hb concentration was calculated as the difference between Baseline and post-baseline measurements. It was recorded for each participant at enrollment (Week 0) and at different time points during the study up to Week 48.|Baseline (Week 0), Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants analyzed at a particular visit is determined by 'n'.||g/dL||Standard Deviation|Mean
118565|NCT00661388|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
118566|NCT00661388|Secondary|Number of Participants Who Received Red Blood Cell Transfusions During the Study Period|Red blood cell transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP (Week 0 to Week 28), EEP (Week 29 to Week 36), and during the long term safety period (LSTP [Week 37 to Week 52]) are presented.|Up to Week 52|Safety population included all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. Number of participants who entered a particular phase is determined by ‘n’.||Number of participants|||Number
118577|NCT00661362|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.||percent||Standard Error|Mean
118578|NCT00661193|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Response) in a Subset of Patients With Measurable Disease||From date of registration to 3 years or death, whichever comes first|||participants|||Number
118567|NCT00661388|Secondary|Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP|Percentage of participants requiring dose adjustments during dose titration period (DTP [Week 0 to Week 28]) and EEP (Week 29 to Week 36) is presented. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either ≥ 13 g/dL or < 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10 to 12 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10.5 to 11.5 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|Weeks 0 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||Percentage of participants|||Number
118568|NCT00661388|Secondary|Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP|Mean time spent by participants in the target range of 10.0- 12.0 g/dL during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||Days||Standard Deviation|Mean
118569|NCT00661388|Secondary|The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP|The percentage of participants whose Hb Concentrations remained within the target range of 10.0- 12.0 g/dL throughout the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up variable were included. Participants with less than three recorded Hb values during EEP; participants missing administration of C.E.R.A. during weeks 28-36; participants with inadequate iron status, were excluded.||Percentage of participants||95% Confidence Interval|Number
118570|NCT00661388|Secondary|Mean Time to Achievement of Response During the EEP|Participants with Hb concentrations within target range of 10-12 g/dl were considered to be responders. Mean time to achievement of response during the EEP (Week 29 to Week 36) is presented.|From Week 29 to Week 36|PP population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||Days||Standard Deviation|Mean
118571|NCT00661388|Primary|Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period|Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP [Week 29 to Week 36]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.|From Baseline (Week 0) to EEP (Week 29 to Week 36)|Per protocol (PP) population included all participants who received at least one dose of C.E.R.A. and had at least one follow-up. Participants with less than three recorded Hb values during EEP; missing administration of C.E.R.A. during weeks 28-36; having inadequate iron status, were excluded.||g/dL||Standard Deviation|Mean
118572|NCT00661362|Secondary|Proportion of Patients Achieving a Therapeutic Glycemic Response|Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.||Percentage of participants|||Number
118573|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.||mg*min/dL||Standard Error|Mean
118574|NCT00661362|Secondary|Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup|Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.|Baseline , Week 24|MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data.||mmol*min/L||Standard Error|Mean
118575|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement||mg/dL||Standard Error|Mean
118576|NCT00661362|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement||mmol/L||Standard Error|Mean
118580|NCT00661089|Primary|Change in Pain Rating From Baseline to Four Weeks|Change scores from patient ratings VAS on mm scale for worst pain, averaged over a week for ratings performed at baseline and week four. Scale range 0-100 mm. 0= No pain, 100= worst pain|baseline and four weeks|||units on a scale 0-100mm||Inter-Quartile Range|Median
118581|NCT00661089|Secondary|Ability to Perform Hygiene Rating||2,4,12, and 16 weeks||||||
118582|NCT00661089|Secondary|Time to Don a Pull Over Shirt||2,4,12, and 16 weeks||||||
118583|NCT00661089|Secondary|Change in Disability Assessment Scale for Hygiene|Subject rating of scores on the Disability Assessment Scale Range 0-3, 0= no disability, 3= severe disability|baseline and 4 weeks post injection|||units on a scale from 0-3||Inter-Quartile Range|Median
118584|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)|||ng*h/mL||Standard Deviation|Mean
118585|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng*h/mL||Standard Deviation|Mean
118586|NCT00660985|Primary|Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24))|area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24 hr (corresponding to the dosing interval)|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng*h/mL||Standard Deviation|Mean
118587|NCT00660985|Primary|Tmax (hr) at Day 30|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 20 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 30.||hours||Standard Deviation|Mean
118588|NCT00660985|Primary|Tmax (hr) at Day 15|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 23 subjects in the Differin Gel 0.3% and 7 subjects in the Differin Gel 0.1% were detectable at Day 15.||hours||Standard Deviation|Mean
118589|NCT00660985|Primary|Tmax (hr) at Day 1|the time at which Cmax occurs|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 14 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 1.||hours||Standard Deviation|Mean
118590|NCT00660985|Primary|Cmax (ng/mL) at Day 30|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose)|||ng/mL||Standard Deviation|Mean
118591|NCT00660985|Primary|Cmax (ng/mL) at Day 15|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng/mL||Standard Deviation|Mean
118592|NCT00660985|Primary|Cmax (ng/mL) at Day 1|the observed peak drug (adapalene) concentration|T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)|||ng/mL||Standard Deviation|Mean
118593|NCT00660907|Secondary|Proportion of Participants With Body Weight Reduction of at Least 5%|To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values||Percentage of participants||95% Confidence Interval|Least Squares Mean
118594|NCT00660907|Secondary|Proportion of Participants With at Least One Episode of Hypoglycemia|To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 52|Full analysis set||Percentage of participants||95% Confidence Interval|Least Squares Mean
118595|NCT00660907|Secondary|Adjusted Mean Change in Body Weight|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values||kg||95% Confidence Interval|Least Squares Mean
118596|NCT00660907|Primary|Adjusted Mean Change in HbA1c Levels|To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values||percent||95% Confidence Interval|Least Squares Mean
118597|NCT00660829|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 Days|||Participants|||Number
118598|NCT00660829|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Scores for a series of subscales are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days|ITT||Units on a scale||Standard Deviation|Least Squares Mean
118835|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 12 Months||initiation and 12 months|The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded.||mmHg||Standard Deviation|Mean
118599|NCT00660829|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"Reflective secondary complex symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days|||Scores on a scale||Standard Deviation|Least Squares Mean
118600|NCT00660829|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14-days|ITT||Scores on a scale||Standard Deviation|Least Squares Mean
118601|NCT00660829|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days|||Scores on a scale||Standard Error|Least Squares Mean
118602|NCT00660829|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least Means Square was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as co-variate"|baseline and 14 days|ITT||Scores on a scale||Standard Deviation|Least Squares Mean
118603|NCT00660816|Secondary|Disease Stabilization Rate (e.g., Complete Response, Partial Response, and Stable Disease)|Estimated based on number of evaluable patients with complete response, partial response or stable disease|36 months after enrollment of last patient|Patients with a complete response, partial response, stable disease, or progressive disease||participants|||Number
118604|NCT00660816|Secondary|Response Rate|Estimated based on the number of responses by excluding the dropouts who are not evaluable for response using a binomial distribution|36 months after enrollment of last evaluable patient|Patients with a complete response, partial response, stable disease, or progressive disease||participants|||Number
118605|NCT00660816|Secondary|Overall Survival|Measured from the date of randomization to the date of death, whichever occurs first and censored at the date of last followed for those survivors|36 months after enrollment of last patient|||Months||95% Confidence Interval|Median
118606|NCT00660816|Primary|Progression-free Survival|From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.|18 months after enrollment of last patient|||Months||95% Confidence Interval|Median
118607|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year|30 out of 48 participants completed all components of study treatment.||percentage of participants||95% Confidence Interval|Number
118608|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of study treatment.||months||95% Confidence Interval|Median
118609|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|2 years|||percentage of participants||95% Confidence Interval|Number
118610|NCT00660699|Post-Hoc|Incidence of Disease Recurrence||Median follow-up was 24 months (range 3.2-97 months)|||percentage of participants|||Number
118611|NCT00660699|Secondary|Overall Survival (OS)|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up|1 year|||percentage of participants||95% Confidence Interval|Number
118612|NCT00660699|Secondary|Overall Survival (OS) - Median|OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.|Median follow-up was 24 months (range 3.2-97 months)|||months||95% Confidence Interval|Median
118613|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)|30 out of 48 participants completed all components of the study therapy.||months||95% Confidence Interval|Median
118614|NCT00660699|Secondary|Disease Free Survival (DFS) - Median|DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.|Median follow-up was 24 months (range 3.2-97 months)|||months||95% Confidence Interval|Median
118615|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 3-4)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)|||percentage of participants|||Number
118616|NCT00660699|Secondary|Toxicities Associated With Treatment (Grade 1-2)|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome.|30 days after completion of treatment (treatment lasts approximately 19 weeks)|||percentage of participants|||Number
118617|NCT00660699|Primary|Incidence of Severe Toxicities|Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0|1 month after completion of treatment (treatment lasts approximately 19 weeks)|||percentage of participants|||Number
118618|NCT00660660|Secondary|Monetary Value of Work Hours Saved|The monetary value of the work hours saved was derived from questions 2,4, and 5 of the WPAI and a standard hourly compensation rate reported by the US Bureau of Labor Statistics (US$28.48 as of June 2008).|Week 4|Results based on MITT population with available data for this outcome measure.||Monetary value (US dollars)||Standard Deviation|Least Squares Mean
118619|NCT00660660|Secondary|Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)|To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.|Baseline and 4 weeks|||Percentage||Standard Deviation|Mean
118620|NCT00660660|Secondary|Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)|Equivalent number of work hours missed was derived from questions 2, 4 and 5 of the Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (Gastroesophageal Reflux Disease) and summed up with the percent work impairment during the remaining hours that were actually worked.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage||Standard Deviation|Mean
118621|NCT00660660|Secondary|Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)|Degree of sleep disturbance affecting work productivity. 100% is considered to be the worst outcome where there is no ability to work. 0% is considered to be the best outcome, no impairment.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage||Standard Deviation|Mean
118622|NCT00660660|Secondary|Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)||4 weeks|Results based on MITT population with available data for this outcome measure.||Work hours||Standard Deviation|Mean
118623|NCT00660660|Secondary|Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.|Number of patients with 24-hour heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118624|NCT00660660|Secondary|Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number of patients with daytime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21-28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118625|NCT00660660|Secondary|Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study|Number and percentage of patients with nighttime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118626|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118627|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118628|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118629|NCT00660660|Secondary|Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118630|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118807|NCT00659789|Secondary|Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths|Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.|Up to week 52|Safety Population||participants|||Number
118631|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118632|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118633|NCT00660660|Secondary|Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118634|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118635|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118636|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “none” on at least 6 of 7 days, allowing for 1 “mild” response.'|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118637|NCT00660660|Secondary|Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment|"To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Results based on MITT population with available data for this outcome measure. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of none on at least 6 of 7 days, allowing for 1 mild response.'"|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118638|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118639|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118640|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118641|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118642|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118643|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118644|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118645|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118646|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118647|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118648|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118649|NCT00660660|Secondary|Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 1 week of treatment. Results based on MITT population with available data for this outcome measure. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of “None” on 7 consecutive days.|1 week|||Percentage of participants|||Number
118650|NCT00660660|Secondary|Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Days to complete resolution of sleep disturbance. Days to complete resolution of sleep disturbances associated with GERD was defined as the number of days until the first day of the first 7‑consecutive-day period during which the patient’s daily diary response was “No” (did not have trouble sleeping due to GERD symptoms).'|4 weeks|Results based on MITT population with available data for this outcome measure.||Days||Full Range|Median
118651|NCT00660660|Secondary|Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|4 weeks|||Days||Full Range|Median
118652|NCT00660660|Secondary|Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days, and ‘days to first relief’ was defined as the first day of the 7 days that reached relief of sleep disturbance.|4 weeks|Results based on MITT population with available data for this outcome measure.||Days||Full Range|Median
118653|NCT00660660|Secondary|Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)as measured by: Percent of days without sleep disturbances after 4 weeks of treatment. Each morning of the study, patients registered their answer “Yes” or “No” to the question, “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?” in the diary card.'|4 weeks|Results based on MITT population with available data for this outcome measure.||Percentage of days||Standard Deviation|Mean
118654|NCT00660660|Secondary|Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of Participants|||Number
118668|NCT00660595|Primary|Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)|PANSS-EC score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS-EC consists of 5 items (Poor IMpulse Control, Tension, Hostility, Uncooperativeness, and Excitement), each with associated descriptors. Each descriptor is rated on a 7 point scale from 1 = (absence of any symptom) to 7 = (extremely severe symptoms).|baseline and 3 weeks|||units on a scale|||Number
118655|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|4 weeks|Results based on MITT population with available data for this outcome measure.||Participants|||Number
118656|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|2 weeks|Results based on MITT population with available data for this outcome measure.||Participants|||Number
118657|NCT00660660|Secondary|Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Relief of sleep disturbances associated with GERD was defined as a daily diary response of “Yes” on not more than 2 of 7 consecutive days.|1 week|Results based on MITT population with available data for this outcome measure.||Participants|||Number
118658|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Complete resolution of sleep disturbances on the patient's last 7 days in the study.|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Participants|||Number
118659|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?”. Complete resolution of Gastroesophageal Reflux Disease (GERD)-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days during 4 weeks of treatment.|4 weeks|||Participants|||Number
118660|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 14 consecutive days.|2 weeks|||Participants|||Number
118661|NCT00660660|Secondary|Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.|The assessment was based on patients registrations of the answers “Yes” or “No” to the question: “Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?”. Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of “No” on 7 consecutive days.|1 week|||Participants|||Number
118662|NCT00660660|Secondary|Achievement of Developer-defined Good Sleep|To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with ‎Gastroesophageal reflux disease (GERD), as measured by achievement of (yes/no) developer-defined good sleep (global Pittsburgh Sleep Quality Index - PSQI score ≤5) at Week 4.|4 weeks|Results based on MITT population with available data for this outcome measure.||Participants|||Number
118663|NCT00660660|Secondary|Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline|To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, “no difficulty” to 3, “severe difficulty.” Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.|Baseline and 4 weeks|Results based on MITT population with available data for this outcome measure.||Scores on a scale||Standard Deviation|Least Squares Mean
118664|NCT00660660|Primary|Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.|Relief of nighttime heartburn on patient’s last 7 days in the study. Relief was defined as a daily diary card response of “none” or 0, on at least 6 of 7 days, allowing for one “mild” or 1 response. Diary card scale (none, mild, moderate, severe).|Days 21- 28 (for early dropouts the last 7 days staying in the study)|Results based on MITT population with available data for this outcome measure.||Percentage of participants|||Number
118665|NCT00660595|Secondary|Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)|PANSS score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS consists of 7 positive and 11 negative items each with associated descriptors. Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).|baseline and 3 weeks|||units on a scale|||Number
118666|NCT00660595|Secondary|Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)|The Overt Agression Scale (OAS) change was to be measured by calculating the difference between baseline score and 3 week's score. Score between 1 and 16 verbal aggression (OAS 1, score 1-4), physical aggression against objects (OAS 2, score 5-8), physical aggression against self (OAS 3, score 9-11) and physical aggression against other people (OAS 4, score 12-16).|baseline and 3 weeks|||units on a scale|||Number
118667|NCT00660595|Secondary|Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 Weeks)|The CGI change was to be measured by calculating the difference between baseline score and 3 week's score. CGI-S Score of 1 = no illness to score of 7 = extremely ill. CGI-I Score of 1 =very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment|baseline and 3 weeks|||units on a scale|||Number
118669|NCT00659490|Secondary|Time to Max Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
118670|NCT00659490|Secondary|Time to Max Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
118671|NCT00659490|Secondary|Time to Max Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
118672|NCT00659490|Secondary|Time to Max Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||minutes||Standard Deviation|Mean
118673|NCT00659490|Secondary|Time to Max Deterioration in VAMS Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||Minutes||Standard Deviation|Mean
118674|NCT00659490|Secondary|Maximum Deterioration in VAMS Down|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included. The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
118675|NCT00659490|Secondary|Maximum Deterioration in VAMS Sedated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
118676|NCT00659490|Secondary|Maximum Deterioration in VAMS Anxious|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
118677|NCT00659490|Secondary|Maximum Deterioration in VAMS High|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
118853|NCT00659165|Secondary|% Body Fat by Bioelectrical Impedance||Once during each hospital admission||||||
118678|NCT00659490|Secondary|Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated|Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.|Between dosing and 12h post-dose|Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
118679|NCT00659490|Secondary|Number of Patients Requesting Rescue Medication|Observed case.|End of surgery up to 8hours following surgery|The analyses are based on a per-protocol population.||Participants|||Number
118680|NCT00659490|Secondary|Time to First Intake of Rescue Medication.||From end of surgery to 8 hours following surgery|Only patients actually taking rescue medication are included in analysis.||Hours||Standard Deviation|Mean
118681|NCT00659490|Secondary|Pain at Jaw Movement at Time of First Rescue Medication|"Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case.~Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication (before 8 hours after end on surgery)|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
118682|NCT00659490|Secondary|Pain at Rescue Medication|"Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case.~Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)."|At time of first rescue medication taken before 8 hours after end of surgery|Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.||mm||Standard Deviation|Mean
118683|NCT00659490|Secondary|Mean Pain at Jaw Movement|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ).|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
118684|NCT00659490|Secondary|Maximum Pain at Jaw Movement|"Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
118685|NCT00659490|Secondary|Pain at Jaw Movement AUC0-4h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable).|0-4h after end of surgery to 4 hours post surgery|The analyses based on a per-protocol pop.||mm*h||Standard Deviation|Mean
118686|NCT00659490|Secondary|Pain at Jaw Movement AUC0-8h|Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable)|0-8h from end of surgery to 8 hours post surgery|The analyses based on a per-protocol pop.||mm*h||Standard Deviation|Mean
118687|NCT00659490|Secondary|Mean Pain Based on a VAS Scale|Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)|From end of surgery to 8h or time to first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
118688|NCT00659490|Secondary|Maximum Pain Based on VAS Scale|"Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)"|From end of surgery to 8h or time first intake of rescue medication (whichever came first)|The analyses based on a per-protocol population.||mm||Standard Deviation|Mean
118689|NCT00659490|Secondary|Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-4h (from end of surgery to 4 hours post surgery)|The analyses based on a per-protocol population.||mm*h||Standard Deviation|Mean
118690|NCT00659490|Primary|Pain Area Under the Curve 0-8h (AUC0-8h)|Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.|0-8 h(from end of surgery to 8 hours post surgery)|The analyses based on a per-protocol population.||mm*h||Standard Deviation|Mean
118691|NCT00659438|Secondary|Number of Patients With CECs, CTCs and Gene Signature Profile of CTCs|"To investigate the relationship between response to vandetanib, CTCs and CECs. To investigate gene signature profile of antiangiogenic response by gene micro-array analysis of CTCs.~Gene signature profile of CTCs was aimed to be compared before and after 2 months of treatment. No blood sample has been taken for the study, and so results on CTCs, CECs of tumour vessels and gene and signature profiles of CTCs were not performed."|4 months||||||
118808|NCT00659789|Primary|Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.||From Week 28 to Week 52|ITT Population||participants|||Number
118809|NCT00659737|Primary|Number of Participants With Postoperative Nausea and Vomiting||0-24 hours|||participants|||Number
125623|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Plantar Reflex’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
118692|NCT00659438|Secondary|Number of Circulating Endothelial Cells (CEC) of Tumour Blood Cells (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CEC. Numbering of CECs was to be performed at baseline, 1 week, 1 month and 2 months after randomisation.~Correlation between the number of CECs and PSA response was to be estimated after 1 week, 1 month and 2 months of treatment."|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.|||||
118693|NCT00659438|Secondary|Number of Circulating Tumour Cells (CTC) (in Patients Included in Ile de France Centres Only)|"To investigate the effect of vandetanib on CTC. Numbering of CTCs to be performed at baseline, 1 week, 1 and 2 months after randomisation. This study was proposed only to patients followed in a study centre located in Ile de France.~Correlation between the number of CTCs and PSA response was to be estimated after 1 week, 1 and 2 months of treatment"|4 months|This part of the study was proposed only to patients followed in one study centre located in Ile de France and finally no blood sample has been taken at this centre. So no data on CTCs, CECs were collected and no analysis was performed.|||||
118694|NCT00659438|Secondary|Progression Rate From the Radionuclide Bone Scanning|To describe the effect of vandetanib on progression rate from the radionuclide bone scanning in a sub-group of patients who had a bone scan within 3 to 6 months after 1st treatment dose. Number of participants with at least 2 new lesions on the radionuclide bone scan compared to baseline assessment were counted for calculation of progression rate.|4 months|||Participants|||Number
118695|NCT00659438|Secondary|Overall Survival (OS)|To investigate the effect of vandetanib on overall survival. Patients alive at the time of the statistical analysis were censored at the time they were last known to be alive. Due to censored data, median overall survival in the placebo group cannot be calculated. OS defined as the number of participants who were alive.|End of study (July 2011)|||participants|||Number
118696|NCT00659438|Secondary|PSA Response Rate|"To investigate the effect of vandetanib on the PSA response rate. PSA response rate defined by the number of participants with a PSA decrease relative to baseline of at least 50%.~A minimum decrease of 2 ng/mL in absolute value and a confirmation on at least 2 consecutive occasions (at least 4 weeks apart) were requested."|4 months|||Participants|||Number
118697|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to onset of cancer-related symptoms was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months|||weeks||95% Confidence Interval|Median
118698|NCT00659438|Secondary|Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)|Due to the difficulties to assess biological progression date when clinical progression has occurred first, and because of the non-assessment of the clinical progression after treatment discontinuation, Time to PSA progression was not evaluated. PFS was evaluated instead, whether biological or clinical progression.|4 months|||weeks||95% Confidence Interval|Median
118699|NCT00659438|Primary|Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months|"To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set).~PSA progression free rate defined as the number of participants with :~After decline from baseline: a 25% increase above the nadir~No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)"|4 months|||Participants|||Number
118700|NCT00659373|Primary|Change in Cognitive Function Over 1 Year in Premenopausal Breast Cancer Patients Who Receive Adjuvant Tamoxifen (T) Alone Against Those Receive Adjuvant Tamoxifen (T+OFS) or Exemestane (E+OFS) With Ovarian Function Suppression (OFS)|Objective cognitive function measured with CogState, a computerized test battery of 7 tasks: Detection, Identification, Monitoring, Memory, Learning, International Shopping List Task (ISLT) and ISLT-Delayed Recall. Performance speed is measured for Detection/Identification/Monitoring and performance accuracy is measured for Memory/Learning/ISLT/ISLT-Delayed Recall. Performance speed calculated as mean of the log10 transformed reaction time for correct responses (lower score=better); performance accuracy calculated as arcsine transformation of the proportion of correct responses (higher scores=better). Main outcome measure is a composite score (average of task scores after transformation and standardization by age-specific norms). A positive standardized score indicates that a patient performed better than average; a negative standardized score indicates below average results. Patients complete assessments at baseline and 1 year after randomization to parent IBCSG 24-02 (SOFT) study.|1 year after patient randomization to parent IBCSG 24-02 study|||standardized units||Standard Deviation|Mean
118701|NCT00659360|Secondary|Time to Disease Progression|"The Kaplan-Meier method will be used to estimate time to progression estimates.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 5 years|||months||95% Confidence Interval|Median
118702|NCT00659360|Secondary|Duration of Response|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;~Objective Tumor Response of more than 4 months was counted toward the Disease Control Rate."|Up to 5 years||||||
118703|NCT00659360|Secondary|Stable Disease Rate|Achieved stable disease as their best response|Up to 5 years|||participants|||Number
118704|NCT00659360|Secondary|Overall Survival|Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.|Up to 5 years|||months||95% Confidence Interval|Median
118705|NCT00659360|Secondary|Objective Response Rate|Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 5 years|||participants|||Number
118723|NCT00660400|Primary|Percentage of Participants With Relapse-free Survival (RFS)|Relapse-free survival one year after allogeneic HCT in MDS patients receiving at least one complete cycle of 5-azacitidine (Vidaza) in the pre-transplantation setting. Relapsed disease: if with complete remission (CR) - greater than 5% blasts in bone marrow; if with partial response (PR) - greater than 30% increase in blasts in the marrow; if with stable disease (SD) - return to pretreatment peripheral blood levels and transfusion requirements due to disease.|One year post allogeneic HCT|Participants who proceeded to allogeneic HCT||percentage of participants||95% Confidence Interval|Number
118706|NCT00659360|Primary|Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.|Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|Up to 5 years|||participants|||Number
118707|NCT00659334|Secondary|Compare Pre- and Post-op Gd Enhanced MRI Combidex Enhanced MR Imaging Done Pre-, Intra- and Post-operatively, to Assess the Degree of Resection and Residual Tumor.||2 years||||||
118708|NCT00659334|Secondary|Compare Combidex Imaging in Brain Tumor Patients, With Other CNS Inflammatory Lesions Such as Multiple Sclerosis and Stroke.||2 years||||||
118709|NCT00659334|Secondary|Assess the Cellular Uptake of Particles in Brain Tumor Patients by Comparing Imaging Results With Histology and Electron Microscopic Examination of Biopsy Tissue||2 years||||||
118710|NCT00659334|Primary|Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.|Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.|24 hours (some patients between 3 and 72 hours) after administration of Combidex|||Participants|||Number
118711|NCT00660543|Primary|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).|Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.|||participants|||Number
118712|NCT00660543|Primary|Mean Cerebral Blood Volume (CBV)|Radiographical progression is determined based on RANO criteria.|At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)|All patients with treated GMB showed apparent tumor progression on conventional MR images.||mL/g||Standard Deviation|Mean
118713|NCT00660517|Secondary|Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.|day 1 to day 14|Intent to Treat(ITT) population (18 years of age or older) who have had at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
118714|NCT00660517|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in the 12 hour instantaneous total nasal symptoms score(iTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value."|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy evaluation||units on a scale||Standard Deviation|Least Squares Mean
118715|NCT00660517|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in the 12 hour reflective total nasal symptoms score(rTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.|day 1 to day14|Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation||units on a scale||Standard Deviation|Least Squares Mean
118716|NCT00660504|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|participants were followed for the duration of the study, an average of 12 weeks|||percentage of participants|||Number
118717|NCT00660504|Secondary|Progression-Free Survival||1.5 years after last subject enrolled|||month||95% Confidence Interval|Median
118718|NCT00660504|Other Pre-specified|Overall Survival at 6 and 12 Months||6 and 12 months.|||percentage of patients||95% Confidence Interval|Number
118719|NCT00660504|Primary|Overall Survival||1.5 years after last subject enrolled|||month||95% Confidence Interval|Median
118720|NCT00660400|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival for all participants at one year after first dose of 5-azacitidine (Vidaza). Overall survival was calculated by the method of Kaplan-Meier with standard errors computed using Greenwood's formula.|One year|Participants who proceeded to allogeneic HCT||percentage of participants||95% Confidence Interval|Number
118721|NCT00660400|Secondary|Percentage of Participants Who Proceed to Hematopoietic Cell Transplantation (HCT)|Proportion of patients enrolled who subsequently proceeded to allogeneic HCT.|Up to 3 years|All participants||percentage of participants|||Number
118722|NCT00660400|Secondary|Overall Response Rate (ORR)|Pre-allogeneic HCT responses to 5-azacitidine (Vidaza), based on the International Working Group criteria: Complete Remission (CR); Partial Response (PR); Stable Disease (SD). Point estimates and 95% confidence intervals were calculated for the response rate to 5-azacitidine, evaluated at marrow evaluation after 4 cycles of 5-azacitidine or prior to HCT whichever came first. CR: Bone marrow with 5% myeloblasts and normal maturation of all cell lines. PR: All CR criteria if abnormal before treatment except bone marrow blasts decreased by 50% over pretreatment but still > 5%. SD: Failure to attain CR, PR, relapsed (or progressive) disease.|At the end of up to six (28 day) cycles of 5-azacitidine|Participants who proceeded to allogeneic HCT||percentage of participants|||Number
118810|NCT00659724|Primary|Dialyzer Assessment: Venous Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows:~Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: the assessment of the condition of the venous header after rinse-back|||Number of Dialyzers|Participants||Number
118724|NCT00660387|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
118725|NCT00660387|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
118726|NCT00660387|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118727|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118728|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV was totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
118729|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118730|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
118731|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118732|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118740|NCT00660387|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118733|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118734|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118735|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118736|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118737|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118738|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118739|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118789|NCT00660010|Other Pre-specified|Number of Pregnancies Reported by Subjects at Final Questionnaire|The final questionnaire was completed by 20 female subjects who were at least 18 years of age. The total number of pregnancies were reported.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.||Pregnancies|||Number
118741|NCT00660387|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118742|NCT00660387|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118743|NCT00660387|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118744|NCT00660387|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
118745|NCT00660387|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
118746|NCT00660387|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as On time without dyskinesia and On time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
118747|NCT00660387|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
118748|NCT00660348|Primary|Number of Subjects Per Arm With Decrease in Pain Scores|The primary objective of this study is to compare the effectiveness of pain control between intrathecal opioid delivery and standard analgesia delivery method in patients with locally advanced unresectable or metastatic pancreatic cancer. The primary end point is the number of subjects on each arm showing a decrease in the change in VAS self-assessment pain intensity rating (VAS pain rating) at one month from initial treatment with respect to the baseline pain score. The change is defined as (the Pain Score at one month of the treatment - the Pain Score at baseline). Serial pain scores will be collected at all assessment time points. Min: zero cm. Max 10cm. A higher value means worse pain. Subjects on each arm will report pain on a 10 cm Visual Analogue Scale (VAS) pain rating scale, by making a mark on the 10cm horizontal line with a pen and study team will measure distance from the mark to the start of the scale, which will indicate pain score (eg 1 cm, 3 cm 6 cm, etc.).|1 month|One subject was enrolled, and baseline pain score was obtained on questionnaire, but the subject came off-study before follow-up pain score could be collected. Study terminated shortly thereafter. No outcome data were collected.|||||
118800|NCT00659815|Primary|Lens Deposits|Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy.|Over-all study visits, baseline to 1-month|Lens deposits over all scheduled follow-up visits (all eligible, dispensed eyes with non-missing data)||Eyes|Participants||Number
118749|NCT00660309|Secondary|Change From Baseline in Retinal Blood Flow After Aliskiren or Irbesartan|"Retinal blood flow was assessed using the laser Doppler technique. The blood flow in the superior temporal retinal artery in one of the eyes of each study participant was determined.~The Single dose effect of aliskiren or irbesartan was measured as the change/difference between Day 2 and baseline measurements.~The Multiple dose effect of aliskiren or irbesartan wsas measured as the change/difference between Day 15 and Day 2 measurements"|Baseline (Day 1), Day 2 and Day 15.|PD analysis set. This assessment was only conducted at sites with available Canon Laser Blood Flowmeter. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||µL/min||Standard Deviation|Mean
118750|NCT00660309|Secondary|Change in Serum Aldosterone After Captopril, Aliskiren or Irbesartan|"The following serum aldosterone effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
118751|NCT00660309|Secondary|Change in Plasma Angiotensin II After Captopril, Aliskiren or Irbesartan|"The following angiotensin II effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
118752|NCT00660309|Secondary|Change in Plasma Angiotensin I After Captopril, Aliskiren or Irbesartan|"The following angiotensin I effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
118753|NCT00660309|Secondary|Change in Plasma Renin Activity (PRA) After Captopril, Aliskiren or Irbesartan|"PRA was measured by the trapping method and the following effects assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 baseline / Day 2 baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
118754|NCT00660309|Secondary|Change in Plasma Pro-renin Concentration After Captopril, Aliskiren or Irbesartan|"The following plasma pro-renin concentration effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
118755|NCT00660309|Secondary|Change in Plasma Renin Concentration (PRC) After Captopril, Aliskiren or Irbesartan|"The following plasma renin concentration effects were assessed:~The single dose effect (SDE) for captopril, expressed as the ratio to pre-dose measurement on Day 1, = Day 1, 5 hour / Day 1 Baseline.~SDE for aliskiren and irbesartan = Day 2, 5 hour / Day 2 Baseline.~Steady state trough effect (multiple dose effect at steady state; MDE_SS) = Day 15 Baseline / Day 2 Baseline.~Steady State peak effect (maximum multiple dose effect; MDE_Max) = Day 15, 5 hour / Day 2 Baseline.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) = Day 15, 5 hour / Day 2, 5 hour."|Predose (Baseline) and 5 hours post dose on Days 1, 2 and 15.|PD analysis set. The number of patients with data available included in each analysis is indicated by 'N' [Aliskiren, Irbesartan].||ratio||95% Confidence Interval|Geometric Mean
118756|NCT00660309|Secondary|Change From Single Dose Peak to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak - Day 2 peak GFR. Peak GFR was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118801|NCT00659815|Primary|Slit Lamp Findings|Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe.|Over-all follow-up visits from baseline to1 month|Graded Slit Lamp Findings over All Follow-Up Visits (Any finding, All Dispensed Eyes, 151 + 2 possible).||Eyes|Participants||Number
118832|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 24 Months||initiation and 24 months|The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded.||mmHg||Standard Deviation|Mean
118757|NCT00660309|Secondary|Change From Baseline to Steady State Peak in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118758|NCT00660309|Secondary|Change From Baseline to Steady State Trough in Glomerular Filtration Rate (GFR) After Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118759|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Aliskiren or Irbesartan|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118760|NCT00660309|Primary|Change From Single Dose Peak to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~Accumulation of peak effect from single dose to multiple dose (MDE_Acc) was calculated as Day 15 peak – Day 2 peak. Peak RPF was obtained using a moving average concept."|Day 2 and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118761|NCT00660309|Primary|Change From Baseline to Steady State Peak in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~This maximum multiple dose effect (MDE_Max) was calculated as Day 15 peak – Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and Day 15: 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118762|NCT00660309|Primary|Change From Baseline to Steady State Trough in Renal Plasma Flow (RPF) After Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~This multiple dose effect at steady state (MDE_SS) was calculated as Day 15 baseline – Day 2 baseline. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values."|Day 2 and Day 15 at Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) .|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118763|NCT00660309|Primary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Aliskiren or Irbesartan|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 2: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.||mL/min/1.73m^2||Standard Deviation|Mean
118764|NCT00660309|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) After a Single Dose of Captopril|"Glomerular filtration rate (GFR) was measured by the clearance of inulin by autoanalyzer methods.~The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak - Day 1 baseline GFR. Baseline GFR was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak GFR was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data. Analysis includes patients for whom data were available.||mL/min/1.73m^2||Standard Deviation|Mean
118765|NCT00660309|Secondary|Change From Baseline in Renal Plasma Flow (RPF) After a Single Dose of Captopril|"Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods.~The measure of the single dose effect (SDE) for captopril was calculated as Day 1 peak – Day 1 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept."|Day 1: Baseline (10 minutes and 5 minutes pre-treatment and 0 hours) and 1, 2, 3, 4 and 5 hours post-dose.|Pharmacodynamics (PD) analysis set consisted of all patients with available PD data and no major protocol deviations with impact on PD data.||mL/min/1.73m^2||Standard Deviation|Mean
118802|NCT00659815|Primary|Comfort|Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating.|Over-all follow-up visits from baseline to 1 month|Symptoms/Complaints Over-All Scheduled Follow-Up Visits (All Eligible, Dispensed Eyes with non-missing scores)||Units on a Scale|Participants|Standard Deviation|Mean
118766|NCT00660192|Secondary|Number of Participants Satisfied With Treatment|"Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks|||participants|||Number
118767|NCT00660192|Primary|Mean Number of Days of Decrease in Pain Level Using VAS|Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.|4 weeks|||days||Standard Deviation|Mean
118768|NCT00660179|Other Pre-specified|Summary of the First Causes of Morbidity or Mortality|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).~Other worsening of PAH was defined by the combined occurrence of all the following 3 events:~At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.~AND worsening of PAH symptoms including at least one of the following:~a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy~AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (Up to 36 months)|All randomized patients||participants|||Number
118769|NCT00660179|Secondary|Cardiac Index at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study||L/min/m^2||Full Range|Mean
118770|NCT00660179|Secondary|Pulmonary Vascular Resistance at Baseline and Month 6|In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.|Baseline to month 6|All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study||(dyn*sec/cm^5)||Full Range|Mean
118771|NCT00660179|Secondary|Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6|"Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope.~Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope.~Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope.~Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA."|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis||participants|||Number
118772|NCT00660179|Secondary|Change From Baseline to Month 6 in 6-minute Walk Distance|The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.|Baseline to month 6|All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis||metres||Standard Deviation|Mean
118773|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012).|Up to end of study (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
118774|NCT00660179|Secondary|Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of death due to any cause up to the end of treatment (plus 7 days)|Up to end of treatment (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
118775|NCT00660179|Secondary|Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)|Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment.|Up to end of treatment (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
118787|NCT00660023|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants from the ITT Population who fulfill inclusion/exclusion criteria per study protocol.||percentage of participants||95% Confidence Interval|Number
118776|NCT00660179|Primary|Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)|"Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH).~Other worsening of PAH was defined by the combined occurrence of all the following 3 events:~At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks.~AND worsening of PAH symptoms including at least one of the following:~a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy~AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics"|Up to end of treatment (data presented up to month 36)|All randomized patients||percentage of participants-Kaplan Meier|||Number
118777|NCT00660075|Primary|Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)||At the end of the two 6-week interventions|We analyzed all the subjects involved in the study. The analysis was per protocol. We compared data from the placebo phase with the sitagliptin phase.||mmol*h/L||Standard Deviation|Mean
118778|NCT00660049|Secondary|Adverse Events|severity and frequency of adverse events|1 month||12/2016||||
118779|NCT00660049|Primary|Ease of Use for Patients|Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.|Baseline up to 31 days|All participants||participants|||Number
118780|NCT00660023|Secondary|Number of Blood Transfusions During the DTP and EEP|The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||blood transfusions|||Number
118781|NCT00660023|Secondary|Number of Participants Receiving Blood Transfusion During the DTP and EEP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||participants|||Number
118782|NCT00660023|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||percentage of participants|||Number
118783|NCT00660023|Secondary|Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; the number (n) of participants who received at least one dose during the specific period was used for analysis.||mcg||Standard Deviation|Mean
118784|NCT00660023|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.||days||Standard Deviation|Mean
118785|NCT00660023|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.||percentage of participants||95% Confidence Interval|Number
118786|NCT00660023|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population.||g/dL||Standard Deviation|Mean
118788|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of genital development in males. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of genitals. The final visit occurred at a mean age +/- SD of 12.35 +/-1.35 years (range, 10.71 to 14.07 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 6 males (genital development suppression). Study drug was discontinued at the initiation of puberty.||Percentage of subjects|||Number
118803|NCT00659789|Secondary|Effects on Vacc-4x on HIV-1 RNA||Weeks 24,28,32,36,40,44,48,52.|||copies/mL||Standard Deviation|Mean
118790|NCT00660010|Other Pre-specified|Number of Subjects Who Reported Pregnancies at Final Questionnaire|The final questionnaire was completed by 20 females who were at least 18 years of age. The subjects reported on total number of pregnancies resulting in live births or number of miscarriages (spontaneous or elective) and whether the subject was currently pregnant.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.||Subjects|||Number
118791|NCT00660010|Other Pre-specified|Number of Female Subjects Who Reported Regular Menses at Adulthood|Subjects were required to complete final adult questionnaire to provide information on adult reproductive function. Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding.|Posttreatment data were collected from the final adult questionnaire (subjects >= 18 years of age)|A long-term follow-up questionnaire was sent to all subjects who completed at least 1 visit in the posttreatment follow-up period or who discontinued treatment because they entered puberty naturally at the appropriate age. Twenty female subjects (mean age 24.76 years, range 18.87 to 26.66 years) and 0 male subjects completed the questionnaire.||Subjects|||Number
118792|NCT00660010|Other Pre-specified|Mean Time to or Mean Age at Regular Menses in Females After Treatment|Regular menses was defined as 3 or more consecutive days of menstrual-like bleeding and was defined by the investigator's clinical judgment.|Posttreatment during the follow-up period (subjects observed every 6 months until physical and laboratory observations are at pubertal levels)|During the posttreatment period, data were obtained from 32 female subjects. Twenty-seven subjects reported the start of menses, but only 26 subjects reported a menses start date.||years||Standard Deviation|Mean
118793|NCT00660010|Other Pre-specified|Posttreatment Height (ht.) Compared to Standard Population and as Predicted From Ht. at Baseline (BL)|Height was measured by stadiometer and was standardized for age according to standard growth charts. A standardized score of 0 indicated a mean ht. equivalent to mean of a standard population from 2000 CDC standardized ht. charts. Height gain was calculated as ht. - predicted ht. from the Bayley-Pinneau method on the basis of bone age at baseline. Final adult ht. was determined by measurement at final adult ht., if available, or by ht. collected during the follow-up period associated with a growth velocity <1 cm/year or a bone age >14 yrs in females or >15 yrs in males.|Final ht. (measured or provided for final questionnaire in subjects >= 18 years of age) or near final adult ht. (<1 cm/year or bone age > 14 years for females or > 15 years for males)|For the follow-up posttreatment period, the ITT population=40 subjects and the safety population=55 subjects who received at least 1 injection of study drug during the treatment period. Study drug was discontinued at the initiation of puberty. The mean age of subjects at final questionnaire completion was 24.76 years with a range of 18.87 to 26.66.||cm||Standard Error|Mean
118794|NCT00660010|Secondary|Mean Ratio of Bone Age to Chronological Age|Bone age was determined by radiography of the wrist according to the Fels Method. The mean ratio of bone age to chronological age provides information about the slowing of bone age progression. A score = 1 indicates that bone age is equal to chronological age.|Week 24 and Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.||ratio||Standard Deviation|Mean
118795|NCT00660010|Secondary|Mean Stimulated Testosterone Concentrations in Males|Mean stimulated testosterone concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of testosterone occurred at a mean age +/- SD of 12.34 +/- 1.16 (range, 11.14 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All males in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.||ng/dL||Standard Deviation|Mean
118796|NCT00660010|Secondary|Mean Stimulated Estradiol Concentrations in Females|Mean estradiol concentrations were assessed according to the DELFIA (registered trademark) assay. The lower limit of quantitation for estradiol is 5 pg/mL and measurements below this limit are given a value of 5 pg/mL. The final visit for measurement estradiol concentrations occurred at a mean age +/- SD of 10.93 +/- 1.27 (range, 5.59 to 13.24) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|All females in the intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. Study drug was discontinued at the initiation of puberty.||pg/mL||Standard Error|Mean
118797|NCT00660010|Secondary|Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations|Mean peak stimulated visit LH and FSH concentrations were assessed according to the DELFIA (registered trademark) assay. The final visit for measurement of both hormone concentrations occurred at a mean age +/- SD of 11.13 +/- 1.23 (range, 6.73 to 14.07) years.|Baseline, Weeks 4, 12, 24, 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females and 6 males. Study drug was discontinued at the initiation of puberty.||mIU/mL||Standard Deviation|Mean
118798|NCT00660010|Primary|Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)|Suppression of clinical sexual characteristics was defined as regression (improvement) or no progression of breast development in females. Tanner staging is a scale of physical development that defines primary and secondary sex characteristics including size of breasts. The final visit occurred at a mean age +/- SD of 11.05 +/- 1.14 years (range, 6.96 to 12.95 years).|Week 4, Week 48 (Year 1), yearly for 5 years (Week 240), and Final Visit|The intent-to-treat (ITT) population and safety analysis set were identical for the treatment period. The starting population comprised 49 females (breast development suppression). Study drug was discontinued at the initiation of puberty.||Percentage of subjects|||Number
118799|NCT00659945|Primary|Number of Participants Having Post-operative Emesis and Nausea.|Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.|48 hours post surgery|||participants|||Number
118811|NCT00659724|Primary|Dialyzer Assessment: Arterial Header Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows:~Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots."|Each treatment: assessment of the condition of the arterial header after rinse-back|||Number of Dialyzers|Participants||Number
118812|NCT00659724|Primary|Dialyzer Assessment: Fiber Condition|"For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows:~Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)"|Each treatment: assessment of the condition of the dialyzer fibers after rinse-back|||Number of Dialyzers|Participants||Number
118813|NCT00659724|Primary|Ease of Use: Priming Dialysate Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows:~Dialysate Side at 500 ml Priming Volume (check one):~Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air."|Priming at each treatment|||Number of Dialyzers|Participants||Number
118814|NCT00659724|Primary|Ease of Use: Priming Blood Side|"For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows:~Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air.~Very Difficult:Air could not be removed."|Priming at each treatment|||Number of Dialyzers|Participants||Number
118815|NCT00659607|Secondary|Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients~40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient’s BP control result, this range exists"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients||Percentage of patients|||Number
118816|NCT00659607|Secondary|Baseline Severity of Hypertension Factors Affecting the Efficacy Profile|"Efficacy rate by medical characteristic of patients~Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
118817|NCT00659607|Secondary|Previous Medication Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
118818|NCT00659607|Secondary|Medical History Factors Affecting the Efficacy Profile|Efficacy rate by medical characteristic of patients|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
118819|NCT00659607|Secondary|Concomitant Disease Factors Affecting the Safety Profile|Occurrence status of adverse events by Concomitant disease of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients||95% Confidence Interval|Number
118820|NCT00659607|Secondary|Medical History Factors Affecting the Safety Profile|Occurrence status of adverse events by medical history of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients||95% Confidence Interval|Number
118821|NCT00659607|Primary|Effective Rate|"Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows:~Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved)~Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)"|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||Percentage of patients|||Number
118822|NCT00659607|Primary|Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2|Effect on decrease in diastolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||mmHg||Standard Deviation|Mean
118823|NCT00659607|Secondary|Treatment Type Factors Affecting the Safety Profile|Occurrence status of adverse events by Treatment type of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients||Percentage of patients||95% Confidence Interval|Number
118824|NCT00659607|Secondary|Proportion of Geriatric Population Factor Affecting the Safety Profile|Occurrence status of adverse events by Proportion of geriatric population of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients||Percentage of patients||95% Confidence Interval|Number
118825|NCT00659607|Secondary|Age Factors Affecting the Safety Profile|Occurrence status of adverse events by Age category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients||Percentage of patients||95% Confidence Interval|Number
118826|NCT00659607|Secondary|Gender Factors Affecting the Safety Profile|Occurrence status of adverse events by Gender category of patients|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients||Percentage of patients||95% Confidence Interval|Number
118827|NCT00659607|Primary|Change From Baseline in SBP (Systolic Blood Pressure) at Week 2|Effect on decrease in systolic blood pressure|Baseline and End of Study|Out of 6,901 patients, 3,616 patients for the efficacy assessment||mmHg||Standard Deviation|Mean
118828|NCT00659607|Primary|Frequency of Adverse Events||Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients|||Number
118829|NCT00659607|Primary|Unexpected Adverse Events|Occurrence status of unexpected adverse events|Up to 6 years|Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment||Percentage of patients|||Number
118830|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 36 Months||initiation and 36 months|The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded.||mmHg||Standard Deviation|Mean
118831|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 36 Months||initiation and 36 months|The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded.||mmHg||Standard Deviation|Mean
118836|NCT00659581|Secondary|Change From Baseline in Diastolic Blood Pressure at 6 Months||initiation and 6 months|The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded.||mmHg||Standard Deviation|Mean
118837|NCT00659581|Secondary|Change From Baseline in Systolic Blood Pressure at 6 Months||initiation and 6 months|The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded.||mmHg||Standard Deviation|Mean
118838|NCT00659581|Primary|Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events||3 years after initiation of treatment|All of observed 20,443 patients were included as intention to treat set||Number of participants|||Number
118839|NCT00659529|Secondary|Serum Sildenafil Levels||Pre/during therapy||||||
118840|NCT00659529|Secondary|CFQ-R||Pre/post therapy||||||
118841|NCT00659529|Secondary|Exhaled Breath Condensate pH||Pre/post therapy||||||
118842|NCT00659529|Primary|Sputum Elastase||Pre/post therapy|Subjects who completed 6 weeks of sildenafil and had available data for pre/post 6 weeks of sildenafil were analyzed. One subject presented to the final study visit with 1 week of previously unreported symptoms consistent with pulmonary exacerbation, and therefore, efficacy data was not analyzed on that subject as pre-specified in the protocol.||micrograms/mL||95% Confidence Interval|Mean
118843|NCT00659295|Primary|Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events|The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.|Months 0-12|FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once||participants|||Number
118844|NCT00659269|Primary|Change in Neurotoxicity Assessment Between Cycle 4 and Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.|4 weeks|Of the 92 & 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 & 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 & 20 patients in Group 2 (Heavy Metals) and 5 & 9 patients in Group 3 (Vinca)||units on a scale||Standard Deviation|Mean
118845|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 4|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.|4 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 & 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 & 21 patients in Group 2 (Heavy Metals) and 6 & 9 patients in Group 3 (Vinca)||units on a scale||Standard Deviation|Mean
118846|NCT00659269|Primary|Neurotoxicity Assessment at Cycle 2|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.|2 weeks|Of the 92 & 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 & 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 & 25 patients in Group 2 (Heavy Metals) and 9 & 10 patients in Group 3 (Vinca)||units on a scale||Standard Deviation|Mean
118847|NCT00659269|Primary|Neurotoxicity Assessment at Baseline|Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.|At study start; prior to treatment (week 0)|Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)||units on a scale||Standard Deviation|Mean
118848|NCT00659165|Secondary|Serum Satiety Factors|Serum values of centrally acting mediators of satiety(Peptide YY, ghrelin, leptin).|measured at 3 points in time during each hospital admission: at admission, 10 minutes prior to study meal and 60 minutes following study meal||||||
118849|NCT00659165|Secondary|Resting Energy Expenditure|Determined by indirect calorimetry/metabolic cart measurement on the morning of inpatient admission.|performed once during each hospital admission||||||
118850|NCT00659165|Secondary|Food Diary|Food diaries were kept at home for one week prior to admission.|performed daily for each meal during the last week of treatment with each study insulin||||||
118851|NCT00659165|Secondary|24-hour Dietary Recall||performed once during each hospital admission||||||
118852|NCT00659165|Secondary|Satiety Scales|Collected at baseline, after 24 hours of fasting, and after eating.|performed at 3 points in time during each hospital admission: immediately upon hospital admission, and then again at 12 hours and 24 hours.||||||
118855|NCT00659061|Secondary|Percentage of Participants With Wasted Growth|Wasted defined as Weight for Height Z-score < -2SD|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete anthropometric measurements at endline||percentage of participants|||Number
118856|NCT00659061|Secondary|Percentage of Participants With Stunted Growth|Stunted defined as Height for Age Z-score < -2 standard deviation|Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment|Those who had complete anthropometric measurements at endline||percentage of participants|||Number
118857|NCT00659061|Secondary|Percentage of Underweight Participants|Underweight defined as Weight for Age Z score < -2 standard deviation (SD)|Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment|those who had complete baseline anthropometric measures||percentage of participants|||Number
118858|NCT00659061|Primary|Mean Hemoglobin of Participants Post Intervention||Endline Hb taken 4-5 months post enrollment|||g/dL||95% Confidence Interval|Mean
118859|NCT00659061|Primary|Number of Participants With Moderate to Severe Anemia|number of participants with moderate - severe anemia defined as Hb < 10g/dL|Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment|||participants|||Number
118860|NCT00659061|Secondary|Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention||Measurement taken 4-5 months post enrollment|||ug/dl||95% Confidence Interval|Mean
118861|NCT00659061|Secondary|Vitamin A Status of Participants - Post Intervention|Categorized as <20ug/dL; 20-40 ug/dL; >40 ug/dl|Measurement taken 4-5 months post enrollment|those who had endline assessment of serum vitamin A||participants|||Number
118862|NCT00659061|Primary|Number of Participants With Anemia|number with mild to severe anemia (hemoglobin(Hb)<11g/dL)|Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment|||participants|||Number
118863|NCT00658996|Primary|Contact Lens High Contrast Visual Acuity|VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test – Control) in overall logMAR VA.|Over-all follow-up visits, 2 weeks|All eligible, dispensed eyes||LogMAR|Participants|Standard Deviation|Mean
118864|NCT00658996|Secondary|Slit Lamp Findings|Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates|Over-all follow-up visits, 2 weeks|All dispensed eyes, over all follow-up visits||Eyes|Participants||Number
118865|NCT00658996|Primary|Symptoms and Complaints|1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.|Over-all follow-up visits for 2 week period|All eligible, dispensed eyes, Overall follow-up visits.||Scores on a Scale|Participants|Standard Deviation|Mean
118866|NCT00658814|Secondary|Relapse-free Survival|Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease.|Up to 5 years|||months||95% Confidence Interval|Median
118867|NCT00658814|Primary|30-Day Survival|Patients surviving more than 30 days after study registration|30 days|||percentage of participants||95% Confidence Interval|Number
118868|NCT00658814|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL.|Up to 60 days|||percentage of participants||95% Confidence Interval|Number
118869|NCT00658814|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
118870|NCT00658788|Secondary|Tolerability Assessment - Folliculitis||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
118871|NCT00658788|Secondary|Tolerability Assessment - Skin Atrophy||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
118872|NCT00658788|Secondary|Tolerability Assessment - Stinging/ Burning||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
118873|NCT00658788|Secondary|Tolerability Assessment - Telangiectasias||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
118874|NCT00658788|Secondary|Tolerability Assessment - Pruritus||Baseline, 2, 4, 8 and 12 weeks|||participants|||Number
118875|NCT00658788|Secondary|Overall Disease Severity||2, 4, 8 and 12 weeks|||participants|||Number
118876|NCT00658788|Secondary|Percent Change From Baseline in Body Surface Area (% BSA) Affected||2, 4, 8 and 12 weeks|||Percent Change from Baseline||Standard Deviation|Mean
118877|NCT00658788|Secondary|Signs of Psoriasis - Plaque Elevation||2, 4, 8 and 12 weeks|||participants|||Number
118878|NCT00658788|Secondary|Signs of Psoriasis - Scaling||2, 4, 8 and 12 weeks|||participants|||Number
118879|NCT00658788|Secondary|Signs of Psoriasis - Erythema||2, 4, 8 and 12 weeks|||participants|||Number
118880|NCT00658788|Secondary|Global Improvement Score||2, 4, 8 and 12 weeks|||participants|||Number
118881|NCT00658788|Primary|Overall Disease Severity Success (ODS)|Success was defined as a one-grade improvement in ODS from baseline.|8 and 12 weeks|The per protocol population included 170 subjects who completed the 12 week regimen without any major protocol deviations.||percentage of participants||95% Confidence Interval|Number
118898|NCT00658684|Primary|Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume|The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|52 Weeks|The safety analysis set (all subjects who took at least one dose of study drug) was analyzed.||Number of subjects|||Number
118882|NCT00658775|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population||Percentage of Participants|||Number
118883|NCT00658775|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present) Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|ITT Population - all randomized subjects who received at least 1 dose of study drug.||Percentage of Participants|||Number
118884|NCT00658775|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population||Percentage of Participants|||Number
118885|NCT00658723|Secondary|Incidence of Adverse Events||30 days (+14 days)|||% if participants with atleast one AE|||Number
118886|NCT00658723|Secondary|Incidence of Re-treatment|"The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.~In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment."|Intra-operative|||participants|||Number
118887|NCT00658723|Secondary|Incidence of Adverse Events Potentially Related to Transfusion Exposure|The types of events that were potentially related to transfusion exposure could have include hypocalcemia.|Intra-operative up to 1 month (+14 days)|||percentage of particpants|||Number
118888|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Thrombotic Events|The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism|Intra-operative up to 1 month (+14 days)|||percentage of participants|||Number
118889|NCT00658723|Secondary|Incidence of Adverse Events That Are Potentially Related to Bleeding|The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).|Intra-operative up to 1 month (+14 days)|||percentage of particpants|||Number
118890|NCT00658723|Secondary|Incidence of Treatment Failures|If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.|Intra-operative|||percentage of treatment failure|||Number
118891|NCT00658723|Secondary|Proportion of Subjects Achieving Hemostatic Success|The proportion of subjects achieving hemostatic success at 10 minutes following randomization|10 minutes|||percentage of success|||Number
118892|NCT00658723|Primary|Proportion of Subjects Achieving Hemostatic Success|Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.|Intra-operative|||percentage of success|||Number
118893|NCT00658697|Secondary|Toxicity|Treatment related adverse events were graded based on CTCAE v. 3.0.|Assessed each cycle throughout treatment form time of first dose to 30 days post-treatment, up to 2 years|All patients received at least one study therapies||participants|||Number
118894|NCT00658697|Primary|Prostate-Specific Antigen (PSA) Progression at 1 Year After Completing Androgen Deprivation Therapy (ADT)|"For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL.~For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA >2.0 ng/mL.~Any new site of metastatic disease on imagining would be considered progression regardless of PSA value Clinical assessments (Vitals, Physical Exam, Performance Status, PSA and testosterone) were performed every 3 months starting at completion of hormone therapy until PSA progression."|participants were followed for the duration of the study, an average of 2 years|||percentage of participants with data||95% Confidence Interval|Number
118895|NCT00658697|Secondary|Testosterone Recovery|Testosterone recovery was defined as >100 or within DFCI institute normal range (240-950) at one year after the completion of ADT|2 years|All treated patients with assessable testosterone level data||percentage of participants with data||95% Confidence Interval|Number
118896|NCT00658697|Secondary|Time to PSA Progression (TTP)|For prostatectomy patients: at least two serial rising PSA from treatment nadir and PSA > 0.2 ng/mL. For patient receiving radiation therapy alone as primary local therapy, at least two serial rising PSA from treatment nadir and PSA > 2.0 ng/mL. Any new site of metastatic disease on imagining would be considered progression regardless of PSA value|participants were followed for the duration of the study, an average of 2 years|the analysis dataset is comprised of all treated patients||months||95% Confidence Interval|Median
118897|NCT00658697|Secondary|Proportion of Patients With PSA Responses at One Year After the Completion of ADT|The PSA response was defined using two cut-offs: PSA <0.2 ng/mL or PSA <0.01 ng/mL at the one year after completion of ADT.|1 year + 3 month off last ADT injection|"The analysis comprised of all patients received at least one treatment and had PSA data available* for the assessment of PSA responses at one year after completing ADT~*Note excluded 5 patients started treatments but had no PSA information at one year."||percentage of participants with data||95% Confidence Interval|Number
118899|NCT00658684|Secondary|Change From Baseline in Grade of PPBC at Week 28 and 52|"The PPBC assessment was rated on a 6-point scale as follows:~no problems at all~some very minor problems~some minor problems~some moderate problems~severe problems~many severe problems~Change: mean at Week 28 and 52 minus mean at baseline A negative change indicates improvement."|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)||Scores on a scale||Standard Deviation|Mean
118900|NCT00658684|Secondary|The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage|"The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was rated on a 6-point scale as follows:~no problems at all~some very minor problems~some minor problems~some moderate problems~severe problems~many severe problems"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)||Number of subjects|||Number
118901|NCT00658684|Secondary|Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52|"OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).~Change: mean at Week 28 and 52 minus mean at baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=analyzable subjects)||Scores on a scale||Standard Deviation|Mean
118902|NCT00658684|Secondary|Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52|"KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.~KHQ consists of the following domains:~General health perceptions (GHP)~Impact on life~Role limitations~Physical limitations~Social limitations~Personal relationships (PR)~Emotions~Sleep/energy~Incontinence severity measures (ISM)~Change: mean at Week 28 and 52 minus mean at Baseline"|Week 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. (n=number of analyzable subjects)||Scores on a ascle||Standard Deviation|Mean
118903|NCT00658684|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were analyzed. (n=number of analyzable subjects)||mL||Standard Deviation|Mean
118904|NCT00658684|Secondary|Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52|"The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of nighttime micturitions per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)||Number of micturitions||Standard Deviation|Mean
118905|NCT00658684|Secondary|Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of incontinence episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n= number of analyzable subjects)||Number of episodes||Standard Deviation|Mean
118906|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of analyzable subjects)||Number of episodes||Standard Deviation|Mean
118924|NCT00658619|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2||Number of Letters Read Correctly||Standard Deviation|Mean
118907|NCT00658684|Secondary|Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52|"The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|The efficacy analysis set (those who took at least one dose of study drug and contributed data to baseline and at least one valid post-baseline efficacy assessment) was analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using LOCF were also analyzed. (n=number of anlyzable subjects)||Number of micturitions||Standard Deviation|Mean
118908|NCT00658684|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52|"The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.~Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline"|Week 4, 8, 28 and 52|Of the efficacy analysis set, the subjects whose mean number of UUI episodes per 24 hours at baseline was greater than 0 were analyzed. Observed values were used for the analyses. Only at Week 52, the imputed data for missing values by using last observation carried forward (LOCF) were analyzed. (n=number of analyzable subjects)||Number of episodes||Standard Deviation|Mean
118909|NCT00658658|Secondary|Percentage of Participants With Disease Control|"Disease assessments were based on investigator review of scans using modified RECIST version 1.0 criteria. A participant was considered to have disease control if their best response is either a complete or partial response, or stable disease. Participants without a post-baseline assessment were considered to not have disease control. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. A best overall response of SD requires a visit response of SD or better, no earlier than 49 days after the date of enrollment.~Stable disease (SD): Neither sufficient shrinkage of target lesions to qualify for a PR nor sufficient increase to qualify for PD and no progression of existing non-target lesions and no new lesions."|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease||percentage of participants||95% Confidence Interval|Number
118910|NCT00658658|Secondary|Percentage of Participants With an Objective Response|Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria. A participant was considered a responder if their best response was either a complete or partial response. Participants without a post-baseline assessment were considered non-responders. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response (CR): Disappearance of all target and non-target lesions, normalization of tumor markers and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions, no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) or/and maintenance of tumor marker level above normal limits, and no new lesions.|Tumor response was assessed every 8 weeks through week 48 and every 3 months thereafter until disease progression or end of study. The data cut-off for the analysis was 17 June 2015; median duration of study was 47 days.|Safety Analysis Set participants with presence of baseline measurable disease||percentage of participants||95% Confidence Interval|Number
118911|NCT00658658|Primary|Serum Clearance (CL) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||mL/day/kg||Standard Deviation|Mean
118912|NCT00658658|Primary|Half-life (t1/2) for the Terminal Phase (First Dose) or Dosing Interval (Third Dose) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||days||Standard Deviation|Mean
118913|NCT00658658|Primary|Area Under the Concentration-time Curve During the Dosing Interval (AUC0-tau) for Panitumumab|The area under the serum concentration-time curve from time zero to the end of the dosing interval (AUCtau), estimated using the linear trapezoidal method.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||day*μg/mL||Standard Deviation|Mean
118914|NCT00658658|Primary|Minimum Observed Concentration (Cmin) of Panitumumab||First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"PK analysis set; n indicates the number of participants with available data for each time point."||μg/mL||Standard Deviation|Mean
118915|NCT00658658|Primary|Maximum Observed Concentration (Cmax) of Panitumumab|Panitumumab serum concentration was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 400 pg/mL. Concentrations below the LLOQ were set to zero.|First dose (Day 1) and third dose (Day 15/29/43 for the QW, Q2W and Q3W cohorts respectively). Samples were collected over the dosing interval for each treatment cohort (7, 14 or 21 days for QW, Q2W and Q3W cohorts respectively).|"Pharmacokinetic (PK) Analysis Set (all participants who received the correct dose of panitumumab and from whom the PK parameters could be assessed); n indicates the number of participants with available data for each time point."||μg/mL||Standard Deviation|Mean
119017|NCT00657020|Secondary|Mean Percentage of Correct Responses During DIA Task|Mean percentage of correct responses during DIA task was determined.|Approximately 2 hours post dose administration|Number of subjects with complete imaging data on both treatments (nicotine and placebo)||Percentage of responses correct||Standard Deviation|Mean
118916|NCT00658658|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event is defined as an AE that: • is fatal; • is life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • is a congenital anomaly/birth defect; • other significant medical hazard. The investigator assessed whether adverse events were related to panitumumab. The severity of adverse events was based on CTCAE version 3 (with the exception of skin- or nail-related toxicities which were graded using the CTCAE version 3.0 with modifications), according to the following: Grade 1 = Mild (aware of sign or symptom, but easily tolerated); Grade 2 = Moderate (discomfort enough to cause interference with usual activity); Grade 3 = Severe (incapacitating with inability to work or do usual activity); Grade 4 = Life-threatening or disabling; Grade 5 = Fatal.|From first dose date to end of study date. The median duration of study was 47 days.|Safety Analysis Set (all participants who received at least 1 dose of panitumumab)||participants|||Number
118917|NCT00658658|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Three validated assays were used to detect the presence of anti-panitumumab antibodies. Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. All samples confirmed to be positive by drug specificity in either screening immunoassay were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay. The number of participants who developed antibodies to panitumumab is the number of participants with a non-positive (including missing) antibody result at baseline and a positive antibody result at any post-baseline time point.|Before panitumumab administration on Day 1, Day 43, Day 169 and 30 days after last dose for all cohorts.|Safety Analysis Set participants with at least one post-baseline immunoassay result||participants|||Number
118918|NCT00658658|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Any panitumumab related grade 3 or 4 hematologic or non-hematologic toxicity (graded according to the modified Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria) was considered a DLT with the exception of alopecia and fatigue. Hypomagnesemia, nausea, diarrhea, vomiting, and skin or nail toxicities constituted a DLT only of the following occured: • Grade 3 or 4 hypomagnesemia that persisted for at least 5 days despite maximal magnesium replacement; • Grade 3 or 4 diarrhea, nausea, or vomiting that persisted for at least 5 days despite maximum supportive therapy; • Grade 4 skin or nail toxicity.|28 days from initial administration of panitumumab for the 2.5 and 6 mg/kg cohorts and 21 days from first administration for the 9 mg/kg cohort.|DLT Analysis Set (all participants who received at least 1 dose of panitumumab and were evaluated for DLTs and completed at least 28 days (for the 2.5 and 6 mg/kg cohorts) or 21 days (for 9 mg/kg cohort) of therapy unless due to a DLT)||participants|||Number
118919|NCT00658632|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.||Percentage of Participants|||Number
118920|NCT00658632|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.||Percentage of Participants|||Number
118921|NCT00658632|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.||Percentage of Participants|||Number
118922|NCT00658619|Secondary|Change From Baseline in Reading Speed in the Study Eye|Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2||Words per Minute (wpm)||Standard Deviation|Mean
118923|NCT00658619|Secondary|Change From Baseline in Contrast Sensitivity in the Study Eye|Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.|Baseline, 24 Months|Intent-to-Treat: All randomized patients who participated in Stage 2||Number of Letters Read Correctly||Standard Deviation|Mean
118925|NCT00658619|Secondary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 2.54 millimeters squared (mm^2).|Baseline, Month 3, Month 6, Month 9, Month 18, Month 24|Intent-to-Treat: All randomized patients who participated in Stage 2||Disc Area||Standard Deviation|Mean
118926|NCT00658619|Primary|Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye|Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 2.54 millimeters squared (mm^2).|Baseline, Month 12|Intent-to-Treat: All randomized patients who participated in Stage 2||Disc Area||Standard Deviation|Mean
118927|NCT00658606|Secondary|Change in Dermatology Life Quality Index (DLQI)|"The DLQI questionnaire is intended to measure how much a subject’s skin problem affects the subject’s life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst).~A negative change from Baseline represents improvement.~Change is calculated as Week 36- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."||DLQI Score||Standard Deviation|Mean
118928|NCT00658606|Secondary|Time for a 75% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~Only subjects who experienced 75% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who experienced a 75% decrease in PASI were included in the analysis."||Days||Inter-Quartile Range|Mean
118929|NCT00658606|Secondary|Time for 50% Decrease in PASI|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~Only subjects who experienced 50% decrease in PASI were included in the analysis."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who experienced a 50% decrease in PASI were included in the analysis."||Days||Inter-Quartile Range|Median
118930|NCT00658606|Secondary|Time to Relapse|"The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed.~Relapse is defined by a loss of 50% of improvement in PASI."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who achieved a 75% improvement in PASI and then relapsed were included in the analysis."||Days||Standard Deviation|Mean
118931|NCT00658606|Secondary|Percentage of Subjects Who Achieve PASI 90 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
118932|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.~Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
118933|NCT00658606|Secondary|Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16|"The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1.~Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
118934|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study|"A negative change from Baseline represents improvement.~Change is calculated as Week 36- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."||Percentage of BSA||Standard Deviation|Mean
119081|NCT00656058|Secondary|Residual Volume (RV/) Forced Vital Capacity (FVC) Measure (Adults Only)|≥120% baseline value is evidence of obstruction. A decrease below 120% will signify response, any value >120% is non-responsive disease.|Baseline, after 6 cycles, and 6 and 18 months post study drug||12/2016||||
118935|NCT00658606|Secondary|Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16|"A negative change from Baseline represents improvement.~Change is calculated as Week 16- Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Baseline and Week 16|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~The number of participants per arm is consistent for all categories / rows of the data table."||Percentage of BSA||Standard Deviation|Mean
118936|NCT00658606|Secondary|Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 36|"The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).~Only subjects who completed follow-up were included in this analysis."||Percentage of Subjects|||Number
118937|NCT00658606|Primary|Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16|"The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person’s psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst).~PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline.~The Last Observation Carry Forward (LOCF) method was used to impute missing data."|Week 16|The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).||Percentage of Subjects|||Number
118938|NCT00658567|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The total possible score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: ANCOVA, and missing data was imputed using LOCF method. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.||Score on UPDRS-II+III scale.||95% Confidence Interval|Least Squares Mean
118939|NCT00658567|Primary|Antipsychotic Efficacy|"Antipsychotic efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 1 to 100 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.||Scores on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
118940|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]for Zolpidem Tartrate|The area under the zolpidem tartrate plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), then 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.||ng-hr/mL||Standard Deviation|Mean
118941|NCT00658541|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Zolpidem Tartrate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable zolpidem tartrate concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.||ng-hr/mL||Standard Deviation|Mean
118942|NCT00658541|Primary|Maximum Plasma Concentration (Cmax) for Zolpidem Tartrate|The maximum or peak concentration that zolpidem tartrate reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing (hour 0), and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 4, 5, 6, 8, 10, and 12 hours after dose administration|Plasma concentration data for 35 of 38 participants were used in the statistical analysis. One subject dropped from the study during Period I and two subjects dropped from the study after Period I.||ng/mL||Standard Deviation|Mean
118943|NCT00658528|Primary|Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 4|ITT Population||Percentage of Participants|||Number
119082|NCT00656058|Secondary|Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid|Fluid from the bronchoalveolar lavage in adult participants (pediatric optional) will be collected and sent to the lab to be evaluated for infectious diseases by flow cytometry|Day 1 of study|||participants|||Number
118944|NCT00658528|Primary|Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks|"Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:~Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Gread D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline and Week 8|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
118945|NCT00658528|Secondary|Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4|During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.|Week 4|ITT Population||Percentage of Participants|||Number
118946|NCT00658411|Secondary|1-year Post-Transplant Survival|Survival information for the 5 patients who were treated with deferoxamine was collected. This information was used to determine transplant-related mortality, relapse, disease-free and overall survival.|1 year|Stopped early for poor accrual||participants|||Number
118947|NCT00658411|Primary|Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.|"All patients meeting the criteria for Severe iron overload as defined by BOTH:~ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy."|Baseline , 6 month, 1 year|Patients who met criteria for iron overload pre-transplant, as defined by the protocol, were enrolled on study for chelation therapy. Those patients who received therapy were monitored for toxicities using the CTCAE version 3.0.||Participants|||Number
118948|NCT00658385|Primary|Number of Participants With no Serious Adverse Events|The entered value represents the number of participants with the absence of serious adverse events. G-CSF mobilization will be considered safe if there are no more than 1 of 5 patients with SAEs|Up to 14 Days|||participants|||Number
118949|NCT00658333|Secondary|Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals|The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).|Baseline and week 4 to week 6|Safety Population||mg||Standard Deviation|Mean
118950|NCT00658333|Primary|Number of Participants With Response (Yes/no)|The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.|6 weeks|Intent to Treat Population||Participants|||Number
118951|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:~GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1"|Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.||mL/min/1.73m^2||Full Range|Median
118952|NCT00658320|Secondary|Extension Study: Cyclosporine Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) cyclosporine levels and was analyzed at a central laboratory using immunoassay.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.||ng/mL||Standard Deviation|Mean
118953|NCT00658320|Secondary|Extension Study: Everolimus Trough Levels|Blood was collected at all visits after Day 3 for trough (collected 5 minutes before study drug dose) everolimus levels and was analyzed at a central laboratory using liquid chromatography mass spectrometry.|Month 24, Month 48|Participants from the Extension safety population with data available for analyses.||ng/mL||Standard Deviation|Mean
118954|NCT00658320|Secondary|Extension Study: Number of Participants With Adverse Events and Serious Adverse Events|Additional information about Adverse Events can be found in the Adverse Event Section.|24 Months|Participants from the Extension Safety Population.||Participants|||Number
118955|NCT00658320|Secondary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula|"The Nankivell formula was used to calculate GFR at Month 24:~GFR[mL/min]=6.7/C + W/4 - UREA/2 - 100/H^2 + 35 (25 for females) W= body weight [kg] H= height [m] C= serum creatinine [mmol/L] UREA= serum urea [mmol\L]"|Month 24, Month 48|Participants from the Extension Intent-to-treat population with data available for analyses.||mL/min||Standard Deviation|Mean
118956|NCT00658320|Secondary|Extension Study: Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)|"Graft loss was defined as the day the patient started dialysis and was not able to subsequently be removed from dialysis or re-transplant.~Loss-to-follow was a patient who did not experience a treated BPAR, graft loss or death and whose last day of contact was prior to Month 24.~A Graft Biopsy was done within 48 hours of suspect rejection. Biopsies were read by the local pathologist according to the updated Banff ’97 criteria.~Treated BPAR was based on local laboratory biopsy results and was defined as a biopsy Banff criteria graded IA to III that was treated with anti-rejection therapy."|24 Months|Extension Intent-to-treat population.||Participants|||Number
119083|NCT00656058|Secondary|Quality of Life (QOL) Score at Baseline and Follow-up|QOL assessment was conducted using the VARNI for subjects age 5-18 years of age and by SF-36(V2) and FACIT-G, FACT-BMT for those >18 years of age|Pretreatment, after cycles 3 and 6, and 6 and 18 months post study drug||12/2016||||
118957|NCT00658320|Primary|Extension Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula|"Renal function was assessed by glomerular filtration rate (GFR) using the MDRD formula:~GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R C is the serum concentration of creatinine [mg/dL] A is age [years] G = 0.742 when gender is female, otherwise G=1 R = 1.21 when race is black, otherwise R=1~Loss to follow up (in In Primary Core Outcome Measure) is composite efficacy failure and contains incidence of treated BPAR, graft loss, death or loss to follow-up"|Month 24|Participants from the Extension Intent-to-treat population with data available for analyses.||mL/min/1.73m^2||Full Range|Median
118958|NCT00658320|Secondary|Core Study: Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:~Calculated GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|Month 12|||mL/min/1.73m^2||Full Range|Median
118959|NCT00658320|Secondary|Core Study: Number Participants With Combined Graft Loss, Death or Loss to Follow-up|"The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.~A loss to follow-up in graft loss, death or loss to follow-up is a patient who did not experience graft loss or death and whose last day of contact was prior to Day 316, i.e. prior to the Month 12 visit window."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.||Participants|||Number
118960|NCT00658320|Primary|Core Study: Number of Patients With Composite Efficacy Endpoint|"The composite efficacy endpoint consisted of treated biopsy proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up. A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. The allograft was presumed to be lost on the day the patient starts dialysis and was not able to stop dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.~For the individual components (including loss of follow-up)of the composite endpoint, patients are counted for the first event to occur."|12 months|The Intent-To-Treat (ITT) population consisted of all patients randomized after transplantation.||Participants|||Number
118961|NCT00658138|Primary|Percentage of Restorations Scoring Alpha|Restorations were scored Alpha, Bravo or Charlie for retention, post-operative sensitivity, anatomic form, margin integrity, color match, stain resistance, and secondary caries. Alpha score = 'excellent' Bravo = 'acceptable' Charlie = 'unsatisfactory'. Total Alpha scores were evaluated for the primary outcome.|12 months|Analysis was based on the number of study teeth available for review at 12 months||percentage of Alpha scores|Participants||Number
118962|NCT00657709|Secondary|Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine|The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.|upto 7 days after any vaccination|The analysis was done on safety subset population - all subjects enrolled who received study vaccination and provided post-baseline safety data.||Participants|||Number
118963|NCT00657709|Secondary|Percentage of Subjects With hSBA Titers ≥1:8|Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.|1 month after third vaccination|Analysis was done on PP population||Percentages of subjects||95% Confidence Interval|Number
118964|NCT00657709|Secondary|Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.|1 Month after third vaccination|Analysis was done on PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
118965|NCT00657709|Secondary|Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens|Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).|5 months|Analysis was done on PP dataset.||Percentages of Subjects||95% Confidence Interval|Number
118966|NCT00657709|Secondary|Percentages of Subjects With Antibody Response Against the Routine Antigens|"The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.~HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml"|1 Month after third vaccination|Analysis was done on PP population.||Percentages Of Subjects||95% Confidence Interval|Number
118967|NCT00657709|Secondary|Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations|Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.|1 month after third vaccination|Analysis was done on Immunogenicity Routine PP (Pertussis Antigens)||IU/mL||95% Confidence Interval|Geometric Mean
118968|NCT00657709|Secondary|Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)|The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.|1 month after third vaccination|Analysis was done on PP dataset.||IU/mL||95% Confidence Interval|Geometric Mean
119034|NCT00656851|Primary|Myocardial Glucose Utilization Rate|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.|Weeks 0 and 16|||(nmol glucose/g heart muscle/min||Standard Error|Mean
118969|NCT00657709|Secondary|Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ|The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.|1 Month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
118970|NCT00657709|Secondary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)|The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.|1 month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
118971|NCT00657709|Primary|The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)|The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.|one month after the third vaccination|Analysis was done on PP population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentages of subjects||95% Confidence Interval|Number
118972|NCT00657709|Primary|The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination|The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after the third vaccination|Analysis was done on Per protocol (PP)population - All subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Titers||95% Confidence Interval|Geometric Mean
118973|NCT00657657|Secondary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine|||subjects|||Number
118974|NCT00657657|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine|||subjects|||Number
118975|NCT00657657|Secondary|Concentration of Anti-HBs Antibodies|Concentrations are given as Geometric Mean Concentrations (GMCs), calculated on subjects seropositive (subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL) post-challenge dose.|One month after the hepatitis B vaccine challenge dose|||mIU/mL||95% Confidence Interval|Geometric Mean
118976|NCT00657657|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above Pre-defined Cut-off Values|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose|||subjects|||Number
118977|NCT00657657|Primary|Number of Subjects With an Immune Response to a Challenge Dose of Hepatitis B Vaccine|"Immune response to a challenge dose of hepatitis B vaccine is defined as~at least a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive (≥ 3.3 mIU/mL) at the previous available long-term time point, or~a post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in subjects seronegative (<3.3 mIU/mL) at the previous available long-term time point."|One month after the hepatitis B vaccine challenge dose|||subjects|||Number
118978|NCT00657553|Secondary|Response Rate of Participants Given Bortezomib Alone|Fraction of participants on the PIB arm who convert from PR (Partial Response) to VGPR (very good Partial Response) or CR (Complete Response) and those in VGPR to CR|Three Years||||||
118979|NCT00657553|Primary|Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2|"The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates.~Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication."|three years|||participants|||Number
118980|NCT00657371|Primary|Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.|Those polyps reported for Third Eye Retroscope were additional, located behind folds and then found with the colonscope only because they were first detected with the Third Eye Retroscope.||polyps|Participants||Number
118981|NCT00657371|Secondary|Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used.|Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.|2 year study period to collect colonoscopy exam results||||||
118982|NCT00657371|Primary|Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)|After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.|Total 30 minutes procedure time with TER use.|||percent of polyps|Participants||Number
118983|NCT00657358|Primary|Tactile Sensation|Pin prick sensory thresholds (PPT) were obtained by touching the skin in-between the first and second metacarpal bone with a 23-gauge needles which moved freely out of a 10 mL plastic syringe barrel. The pin prick sensation was modified by adding small weights to the 23-gauge needles (from 0.2 to 5.2 gm). A syringe barrel of tuberculin (TB) needles that were cut to different lengths to add the desired weight to the 23-gauge needle. The PPT was determined using the weighted 23-gauge needle in ascending order, according to the method of limits. This assessment was to evaluate whether participants were able to feel the touch of the needle. The participant’s arm was placed on a tray table. A linen sheet was suspended in-between two IV poles in such a fashion that the subject’s view of his/her hand was blocked. Normal values are between 0.21mg and 5mg.|baseline, during 20 minute infusion, and 30 minutes after completion of infusion|||weight in mg||Standard Error|Mean
118984|NCT00657358|Primary|Cold Pain|The participant’s foot was immersed up to the ankle into a container filled with ice water of 3°C. Participants were instructed to maintain their foot in the container until the cold pain became intolerable (cold pain tolerance). The length of time was recorded in seconds. This procedure was repeated once with a gap of at least fifteen minutes in-between repeated tests. The range was 0 seconds to 120 seconds|baseline, during 20 minute infusion, and 30 minutes after lidocaine infusion|||time in seconds to withdrawal||Standard Error|Mean
118985|NCT00657358|Primary|Heat Pain|The thermal procedure involved a baseline assessment of heat pain threshold and tolerance. Contact heat stimuli were delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-II; Ramat Yishai, Israel), which is a peltier elementbased stimulator. Temperature levels were monitored by a thermistor and returned to a preset baseline of 32°C by active cooling at a rate of 10°C/s. The 3 × 3 cm contact probe was applied to the right forearm. The pain scale is between 0 and 10 with 1 being no pain and 10 being the worst pain imaginable|baseline, during 20 minute lidocaine infusion, and 30 minutes after completion of lidocaine infusion|||units on a scale||Standard Error|Mean
118986|NCT00657358|Primary|Electrical Pain|Peripheral nerve stimulation electrodes were attached to the base and the tip of the third digit and connected to a constant current stimulator (DS7A, Digitimer Ltd, Hertfordshire, England). Ascending electrical stimuli of 2000 mu duration, ranging from 0.5 to 35 mA (ampere) was administered one per second in 0.5 mA increments. Participants were instructed to indicate when they first felt the slightest sense of pain (electrical pain threshold, EPTh) and when they were unable to tolerate a further increase (electrical pain tolerance, EPTo). For each measure, the average of three trials was computed for use in subsequent analyses. Each of the three electrical pain stimuli were presented three times and balanced in order using a Graeco-Latin square design. The pain scale is between 0 and 10, with 0 being no pain and 10 being the worst pain imaginable|Baseline, during 20 minutes lidocaine infusion, and 30 minutes after completion of lidocaine infusion|||units on a scale||Standard Error|Mean
118987|NCT00657358|Primary|Ischemic Pain|The right arm was exsanguinated by elevating it above heart level for 30 seconds, after which the arm was occluded with a standard blood pressure cuff positioned proximal to the elbow inflated to twice the participant’s mean arterial pressure. Participants then performed 20 handgrip exercises of 2-second duration at 4-second intervals at 50% of their maximum grip strength. Pain was rated on a scale from 0 - 10 with 0 being no pain to 10 being the worst pain imaginable.|baseline, during 20 minute lidocaine infusion, and 30 minutes after discontinuation of lidocaine infusion|health volunteers||units on a scale||Standard Error|Mean
118988|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|4 years||||||
118989|NCT00657280|Secondary|Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy||2010-2012||||||
118990|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.|2008-2012||||||
118991|NCT00657280|Primary|Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan|This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. Baseline glucose uptake scans will be compared with the scans on sitagliptin thirty days after baseline|30 days|Scans were lost in 4 participants||SUV||Full Range|Mean
118992|NCT00657267|Secondary|Time to Progression.|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.||days||95% Confidence Interval|Median
119061|NCT00656617|Primary|Progression Free Survival (PFS) at 7 Months|Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.|PFS Evaluation at 7 months|Four (4) participants did not receive treatment therefore were not evaluable for outcome assessment.||percentage of participants|||Number
118993|NCT00657267|Secondary|Radiographic Response|Responders on study are those with a best response of either CR or PR. Per Modified Macdonald Criteria for lesions assessed by MRI/CT: Complete Response (CR) = Complete disappearance of all measurable and evaluable disease, no new lesions, no evidence of non-evaluable disease, with no steroids. Partial Response (PR) >/= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, no new lesions, with steroid dose @ time of response </= max dose w/in the first 8 weeks of therapy.|From patient registration until end of study, assessed up to 54 months|Of the 58 patients registered, 3 of were ineligible for analysis based on path review, which is why only 55 patients were evaluated for this outcome.||percentage of participants evaluated|||Number
118994|NCT00657267|Secondary|Overall Survival||From patient registration until end of study, assessed up to 54 months|Entire study population||months||95% Confidence Interval|Median
118995|NCT00657267|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months|Patients evaluable for imaging analysis, as protocol-defined.||percentage of evaluable participants|||Number
118996|NCT00657150|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients||participants|||Number
118997|NCT00657150|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|Treated and operated patients||mL||Standard Deviation|Mean
118998|NCT00657150|Secondary|Blood Transfusion|Number of treated and operated patients with required blood transfusion on day of surgery.|Day 1|Treated and operated patients||participants|||Number
118999|NCT00657150|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|28-35 days|All patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication.||Participants|||Number
119000|NCT00657150|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up||Participants|||Number
119001|NCT00657150|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)||Participants|||Number
119002|NCT00657150|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)||Participants|||Number
119003|NCT00657150|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)||Participants|||Number
119004|NCT00657150|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.)||Participants|||Number
119005|NCT00657150|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|28-35 days|Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT)||Participants|||Number
119006|NCT00657150|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|28-35 days|Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.)||Participants|||Number
119062|NCT00656474|Secondary|Percentage of Wound Epithelialized|The percentage of wound epithelialized was assessed at Day 15 post laser ablation.|Day 15 post laser ablation.|Analysis was Per Protocol.||percent|||Number
119084|NCT00656058|Secondary|Percentage Overall 2-Year Survival|Percentage of participants alive at 2 years.|2 years|This is a multicenter study and the number analyzed reflect data for evaluable subjects enrolled at the National Institutes of Health only.||percentage of participants|||Number
119007|NCT00657150|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|28-35 days|Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)||Participants|||Number
119008|NCT00657046|Post-Hoc|Number Patients With Hypotension Induced Early Termination of Dialysis Procedure||6 weeks|Patients had to have at least one post baseline visit (visit 8 and beyond).||participants|||Number
119009|NCT00657046|Other Pre-specified|Change in Systolic Blood Pressure From Pre-dialysis to Post-dialysis|"Change from baseline (visits 2-7) to end of study (HD visits 14-19) in the drop in systolic blood pressure from pre-hemodialysis to 5 minutes post-hemodialysis.~The baseline value was the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value was defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.||mmHg||Standard Deviation|Mean
119010|NCT00657046|Post-Hoc|Systolic Blood Pressure Difference Between Pre-Hemodialysis and Nadir|Change from baseline to end of study (HD visits 14-19) in systolic blood pressure difference between pre-hemodialysis and nadir.|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. One droxidopa 400 mg patient did not have the required nadir blood pressure information for visits 14-19 and was excluded from the analysis.||mmHg||Standard Deviation|Mean
119011|NCT00657046|Secondary|Change in the Multidimensional Fatigue Inventory (MFI-20)|"Fatigue will be measured by the general fatigue domain (items 1, 5, 12 and 16) of MFI-20 and will be summarized by treatment group and treatment period. The scores per item run from 1 to 5. A higher score indicates more fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). This concerns item: 5 and 16. A total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20.~The value at baseline (visit 7) will be subtracted from the value on treatment (visit 19 or visit 13 if visit 19 is not available)."|6 weeks|Patients must have completed at least visit 14. Three placebo patients did not complete their Multidimensional Fatigue Inventory during this visit.||units on a scale||Standard Deviation|Mean
119012|NCT00657046|Secondary|Daily Symptoms Associated With Hemodialysis|"The Daily symptoms associated with hemodialysis score is the sum of an 8 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at fatigability, malaise/weakness, physical disturbance on standing, coldness of limbs, dizziness/lightheadedness, dizziness on standing, general bad feeling, and sleep disorders and asks how each of these items affected the patients daily activities on that day.~The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 timeframe. Three placebo patients and one droxidopa 600mg patient did not complete their Daily Symptoms Assessments during these visits.||units on a scale||Standard Deviation|Mean
119013|NCT00657046|Secondary|Change in the Hypotension-induced Symptom Severity Score|"The hypotension-induced symptom severity score is the sum of a 6 question scale (each rated 0 [asymptomatic] to 4 [severe]). The questions look at cramps, dizziness, headache, nausea, itchiness, and restless legs syndrome experienced during dialysis.~The outcome looks at the difference between the average baseline score (visits 2-7) and the average on-treatment scores (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19)."|6 weeks|Patients must have completed visits in the visit 14-19 time frame.||units on a scale||Standard Deviation|Mean
119014|NCT00657046|Secondary|Change in the Number of Hypotension-induced Interventions During Hemodialysis (HD) Sessions;|Evaluate the efficacy of droxidopa as measured by change in the number of hypotension-induced interventions during hemodialysis (HD) sessions between baseline (visits 2-7) and treatment (visits 14-19). The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have completed visits in the visit 14-19 timeframe.||average interventions per session||Standard Deviation|Mean
119015|NCT00657046|Secondary|Change in Average Mean Nadir Systolic Blood Pressures During Hemodialysis;|Change between baseline (visits 2-7) and treatment (visits 14-19) in average mean nadir systolic blood pressures during hemodialysis. The baseline value will be the arithmetic average of the values collected at each of the six baseline visits (visits 2-7). The on treatment value will be defined as the average of the values collected at each of the last six treatment visits (visits 14-19).|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.||mmHg||Standard Deviation|Mean
119016|NCT00657046|Primary|Change in Average Mean Arterial Blood Pressure During Hemodialysis|"Change between average baseline (visits 2-7) mean arterial blood pressure during hemodialysis and average treatment (visits 14-19) mean arterial blood pressure during hemodialysis.~The calculation of MAP was based on the systolic (SBP) and diastolic (DBP) blood pressure measurements taken during each valid HD session, using the traditional formula:~MAP = (SBP+2*DBP)/3 for each time-point. The mean of the intradialytic measurements was calculated for each valid HD session, and these daily mean values were averaged across the visits within each period."|6 weeks|Patients must have blood pressure data from baseline and from visits 14-19. One droxidopa 400mg patient did not have blood pressure data for visit 14-19 and was excluded from the analysis.||mmHg||Standard Deviation|Mean
125624|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Cranial Nerve Function’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
119018|NCT00657020|Secondary|Mean Response Time for Correct Responses During DIA Task|"DIA task comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||msec||Standard Deviation|Mean
119019|NCT00657020|Secondary|Percent Mean Change in BOLD Scores During Divided Attention (DIA) Task|"BOLD fMRI signals evaluated different brain ROIs during DIA task which comprised of three conditions: i) Sustained visual attention wherein participant responded to letter s every time it appeared in a continuous stream of letters on a screen; ii) Sustained auditory attention wherein participant responded to the number 8 each time in appeared in a continuous stream of numbers presented through headphones; iii) Divided attention task auditory and visual stimuli wherein participant responded to occurrences of s (visual) and 8 (auditory) simultaneously. Brain ROIs were right and left parietal cortex, visual cortex, superior occipital cortex and right premotor cortex."|Approximately 2 hours post dose admininstration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||Percentage change in BOLD signal||Standard Deviation|Mean
119020|NCT00657020|Secondary|Mean Percentage of Correct Responses During RVIP Task|Percentage of correct responses during RVIP task was determined|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||Percentage of responses correct||Standard Deviation|Mean
119021|NCT00657020|Secondary|Mean Response Time for Correct Responses During RVIP Task|"During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participants responded to single occurrences of the number 0. Mean response time for correct responses was determined."|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||milliseconds (msec)||Standard Deviation|Mean
119022|NCT00657020|Primary|Percent Mean Change in Blood Oxygen-level Dependent (BOLD) Scores During Rapid Visual Information Processing (RVIP) Task|In RVIP task, participant responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. During a control task, participant responded to single occurrences of the number “0”. BOLD fMRI signals evaluated different brain regions of interest (ROI) during RVIP task. Brain ROIs identified were right and left anterior insula, anterior putamen, parietal cortex, premotor cortex, visual cortex, dorsal anterior cingulate cortex, substantia nigra and thalamus.|Approximately 2 hours post dose administration|Number of participants with complete imaging data on both treatments (nicotine and placebo).||Percentage change in BOLD signal||Standard Deviation|Mean
119023|NCT00656968|Primary|Number of Participants Who Had Good Drug Compliance|Good drug compliance is defined as taking equal to or more than 80% of eradication medicines|one month after finishing test therapy|||participants|||Number
119024|NCT00656968|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|one month after finishing study drugs|||participants|||Number
119025|NCT00656916|Primary|Lung Function Non-deterioration Rate|Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of < 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.|Baseline and three months|There was no analysis performed for the protocol due the low enrollment (one participant).||Percentage (FEV1|||Number
119026|NCT00656851|Secondary|Fasting Glucose Insulin and HOMA|fasting plasma glucose, insulin concentrations and HOMA-insulin resistance|Week 0 and 16|||mg/dL µU/mL||Standard Error|Mean
119027|NCT00656851|Secondary|Fasting Lipids and Lipoproteins|fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations|Week 0 and 16|||mg/dL||Standard Error|Mean
119028|NCT00656851|Primary|Myocardial Fatty Acid Esterification|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction|Weeks 0 and 16|||(% of total fatty acid extraction)||Standard Error|Mean
119029|NCT00656851|Primary|Myocardial Fatty Acid Oxidation Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.|Weeks 0 and 16|||(nmol palmitate/g heart muscle/min||Standard Error|Mean
119030|NCT00656851|Primary|Myocardial Fatty Acid Utilization Rate|Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).|Weeks 0 and 16|||(nmol palmitate/g heart muscle/min||Standard Error|Mean
119031|NCT00656851|Primary|Myocardial Glucose Utilization Rate Per Unit Insulin|Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.|Weeks 0 and 16|||(nmol glucose/g heart muscle/min/µU insu||Standard Error|Mean
119032|NCT00656851|Secondary|Myocardial Contractile Function During Systole|Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum|Weeks 0 and 16|||cm/sec||Standard Error|Mean
119033|NCT00656851|Secondary|Myocardial Contractile Function During Diastole|"Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:~blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or E filling velocity.~residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the A (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio <1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure."|Weeks 0 and 16|||ratio||Standard Error|Mean
119035|NCT00656799|Primary|Rate of Clearance of Rocuronium From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
119036|NCT00656799|Primary|Rate of Clearance of Sugammadex From Dialysate|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
119037|NCT00656799|Primary|Rate of Clearance of Rocuronium From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
119038|NCT00656799|Primary|Rate of Clearance of Sugammadex From Blood|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||mL/min||Standard Deviation|Mean
119039|NCT00656799|Primary|Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to Day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||Reduction Ratio||Standard Deviation|Mean
119040|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement||Minutes||95% Confidence Interval|Geometric Mean
119041|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement||Minutes||95% Confidence Interval|Geometric Mean
119042|NCT00656799|Secondary|Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.|Day 1|Intent To Treat (ITT) group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement||Minutes||95% Confidence Interval|Geometric Mean
119043|NCT00656799|Secondary|Number of Participants With Pregnancies at 30 Days Post-dose|Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants|Up to 30 days post -dose|AST consisting of all participants who received a dose of sugammadex||participants|||Number
119044|NCT00656799|Secondary|Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium|Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium|Day 1|AST consisting of all participants who received a dose of sugammadex||participants|||Number
119080|NCT00656084|Primary|Objective Response Rate (CR + PR)|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable Population||percentage of participants||95% Confidence Interval|Number
119045|NCT00656799|Secondary|Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1|Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from >= 0.9 to < 0.8 in at least three consecutive measurements.|Day 1|AST consisting of all screened participants who received a dose of sugammadex||participants|||Number
119046|NCT00656799|Secondary|Number of Participants With Physical Examinations|Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery|Screening up to day 7|AST consisting of all participants who received a dose of sugammadex||participants|||Number
119047|NCT00656799|Secondary|Vital Sign: Mean Heart Rate|Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex||Beats per minute||Standard Deviation|Mean
119048|NCT00656799|Secondary|Vital Sign: Mean Diastolic Blood Pressure|Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex||mm Hg||Standard Deviation|Mean
119049|NCT00656799|Secondary|Vital Sign: Mean Systolic Blood Pressure|Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery|Screening up to 1 day after surgery|AST consisting of all participants who received a dose of sugammadex||mm Hg||Standard Deviation|Mean
119050|NCT00656799|Secondary|Number of Participants With Medical Device (Near) Incidents|A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health.|Up to day 7|AST consisting of all participants who received a dose of sugammadex||participants|||Number
119051|NCT00656799|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect|Up to day 7|AST consisting of all participants who received a dose of sugammadex||participants|||Number
119052|NCT00656799|Secondary|Number of Participants With Pre-treatment Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product.|Screening up to Day 1|All Subjects Treated (AST) consisting of participants who received a dose of sugammadex||participants|||Number
119053|NCT00656799|Primary|Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)|Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.|Up to day 7|All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement||Reduction Ratio||Standard Deviation|Mean
119054|NCT00656669|Secondary|To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy|This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)|All patients who were on paclitaxel plus sunitinib.||participants|||Number
119055|NCT00656669|Secondary|Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer||screening through surgery|All patients who had surgery.||percentage of participants||95% Confidence Interval|Number
119056|NCT00656669|Secondary|Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.|end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)|All patients in the paclitaxel plus sunitinib segment||mm Hg||Standard Deviation|Mean
119057|NCT00656669|Primary|Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy|Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.|baseline through end of segment 1 (2 weeks)|All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment||mm Hg||Standard Deviation|Mean
119058|NCT00656656|Secondary|Side-effects of Treatment||up to 43 months|||Participants|||Count of Participants
119059|NCT00656656|Primary|Number of Patients Achieving a Short- and Long-term Remission of Pemphigus||up to 43 months|||Participants|||Count of Participants
119060|NCT00656617|Secondary|Participant Response|Number of participants with response assessed according RECIST: Complete Response (CR) defined as normalization of marrow (< 5% blasts) and of peripheral blood counts (neutrophil count > 1.109/L, platelet count > 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by >50% compared to pretreatment values but above <5%. Complete Response without platelet recovery (CRp) = CR, but platelets <100 x 109/L. Progressive disease (PD) defined as increase of blasts to > 10% after an initial response.|Monitoring with each 4 week cycle, up to 18 cycles of treatment|Four (4) participants were not treated therefore not evaluable for the outcome assessment.||participants|||Number
119063|NCT00656474|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated every 2 days from the time of the laser procedures for the first 10 days and then seen every 2 weeks for 4 weeks. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.||days||95% Confidence Interval|Median
119064|NCT00656448|Secondary|Number of Participants With Complete Remission|International Working Group (IWG) criteria for responses defined as: Complete Remission (CR) - Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Partial remission (PR): as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%.|Baseline, weekly or until disease progression|||participants|||Number
119065|NCT00656448|Primary|Median Number of Participant Transfusions Required During 12 Weeks of Treatment|"The number and frequency of packed red blood cells (PRBC) transfusions assessed and compared between two groups, treatment group (Procrit) and standard care group (No Procrit). Participants log all PRBC transfusions. Reported are the number of transfusions in the treatment arm during induction and consolidation chemotherapy with the concomitant use of epoetin alfa during therapy, and in the standard arm those that occured during same 12 week period."|12 weeks|||Transfusions per Participant||Full Range|Median
119066|NCT00656370|Secondary|Subject's Global Preference for Infusion (Left vs. Right Thigh)||End of infusion||||||
119067|NCT00656370|Secondary|Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference.||Before the infusion until discharge||||||
119068|NCT00656370|Secondary|Change in Circumference of the Thigh at the Infusion Site||Before the infusion, during the infusion, after the infusion, and discharge||||||
119069|NCT00656370|Secondary|Average Infusion Flow Rate (mL/hr) Derived From the Time to Infuse up to 500mL of Solution||During infusion||||||
119070|NCT00656370|Secondary|Safety Assessment of 15 Participants Who Were Included in the Safety Data Set.|Safety outcome measures included adverse events (AEs), physical examinations, and vital signs.|Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left|||participants|||Number
119071|NCT00656370|Primary|The Subject's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS).|Subject's self-assessment of discomfort at the infusion site by means of a validated visual analogue scale (VAS) with a range of 0 mm (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of NS versus LR, each following an SC slow-push injection of 150 U Hylenex.|Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes.|15 subjects were randomized and completed stage 1||mm||Standard Deviation|Mean
119072|NCT00656201|Primary|Percentage of Pregnant Patients After IVF Treatments|Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval|16 weeks|Number of participants for analysis was determined by completion of the IVF cycle using the specified medications, either Crinone or IM Progesterone||percentage of participants|||Number
119073|NCT00656175|Primary|Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)|Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm^2, not cm^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.|Baseline and 24 weeks|||cm^2||Inter-Quartile Range|Median
119074|NCT00656136|Secondary|Objective Response Rate (OR)|OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.||Percentage of patients with OR||95% Confidence Interval|Number
119075|NCT00656136|Secondary|Progression-free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.||Months||95% Confidence Interval|Median
119076|NCT00656136|Primary|Overall Survival|"Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock.~For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010.~For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013."|From randomization until death or the last patient out date, an average of 12 months|Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.||Months||95% Confidence Interval|Median
119077|NCT00656084|Secondary|Progression-free Survival Rate at 1 Year.|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|1 year.|ITT population||Probability of Progression-free Survival||95% Confidence Interval|Number
119078|NCT00656084|Secondary|Overall Survival (OS) Rate at 1 Year|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year.|ITT population||Probability of Survival||95% Confidence Interval|Number
119079|NCT00656084|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.~CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.||months||Full Range|Median
119086|NCT00656058|Secondary|Leukotriene Receptor Expression (BLT or Cysteinyl Leukotrienes (CysLT)) on Activated Circulating Immune Cells Before and After Treatment|Leukotriene receptor expression on immune cells was analyzed by multiparameter flow cytometry and cytokine studies.|Pretreatment and after cycle 3 and cycle 6||12/2016||||
119087|NCT00656058|Secondary|Leukotriene Levels (LTB4 and Cysteinyl Leukotrienes (CysLT)) in the Blood Before and After Treatment|Blood will be collected and processed for multiparameter flow cytometry to measure leukotriene levels on circulating immune cells (cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8) + T cells, cluster of differentiation 19 (CD19) + B cells, cluster of differentiation 14 (CD14)+ monocytes, macrophages, neutrophils, and eosinophils).|Pretreatment and after cycle 3 and cycle 6||12/2016||||
119088|NCT00656058|Secondary|Leukotriene Levels (LTB4 and Cysteinyl Leuotrienes (CysLT)) in the Urine Before and After Treatment|A 24 hour urine will be collected to measure leukotriene levels after cycle 3 and cycle 6.|After cycle 3 and cycle 6||12/2016||||
119089|NCT00656058|Secondary|Ratio of Forced Expiratory Volume 1 (FEV-1)/Forced Vital Capacity (FVC)|Baseline impairment is <20% of predicted|Baseline and 6 cycle pulmonary function tests||12/2016||||
119090|NCT00656058|Secondary|Carbon Monoxide Diffusing Capacity (DLC02) in Adults Only With Bronchiolitis Obliterans|Baseline impairment is defined as a decrease in DLC0 of at least 25%.|Baseline, 3 month and 6 month on study, and 6 and 8 months post study drug||12/2016||||
119091|NCT00656058|Secondary|Residual Volume (RV) in Pediatric and Adult Patients Greater Than 6 Years With Bronchiolitis Obliterans|Residual volume ≥120% baseline value is evidence of obstruction. A decrease below 120% will signify response, any value >120% is non-responsive disease. Pulmonary function for children must be calculated using the NHANES criteria.|Baseline, 3 month and 6 month on study, and 6 and 18 months post study drug.||12/2016||||
119092|NCT00656058|Secondary|Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)|Pulmonary function test performed for eligibility and baseline.|Baseline|||Ratio||Full Range|Median
119093|NCT00656058|Secondary|Forced Expiratory Flow 25-75 (FEF25-75) in Pediatric and Adult Patients Greater Than 6 Years With Bronchiolitis Obliterans|Baseline impairment is <20% of predicted. Pulmonary function for children must be calculated using the NHANES criteria.|Baseline, 3 and 6 months on study, and 6 and 18 months post study drug||12/2016||||
119094|NCT00656058|Secondary|Timed Walk Test|A timed walk test was preformed to measure pulmonary endurance.|2 minutes and 6 minutes||12/2016||||
119095|NCT00656058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|71 months and 17 days|||participants|||Number
119096|NCT00656058|Primary|Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months|FEV-1 slope of decline was generated using regression line of FEV-1 value vs. days post hematopoietic stem cell transplant. Responsive disease (RD) for the slope of FEV-1 change will be an increase in the slope of absolute FEV-1. Progressive disease (PD) for the slope of FEV-1 change will be a decrease in the slope of absolute FEV-1. Stable disease (SD) for the slope of FEV-1 change will be a 0 change in FEV-1 slope.|180 days|||participants|||Number
119097|NCT00656058|Primary|Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature|Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as >15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as <15% change in the absolute FEV-1.|180 days|No data is available for the one missing participant.||participants|||Number
119098|NCT00655889|Primary|Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population||participants|||Number
119099|NCT00655889|Primary|Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)|A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best.|Baseline (prior to first study treatment) compared to six months after first treatment|Subjects who received at least one treatment during the study were included in the Intent to Treat population||participants|||Number
119100|NCT00655863|Secondary|Change From Baseline in Endothelial Function Through Pulse Wave Tonometry|Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mmHg||Standard Error|Least Squares Mean
119101|NCT00655863|Secondary|Change From Baseline in e-Selectin|The change in e-Selectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
119102|NCT00655863|Secondary|Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)|The change in ICAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
119574|NCT00651040|Primary|The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.|The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.|1 year|||mg/kg||Standard Deviation|Mean
119103|NCT00655863|Secondary|Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)|The change in VCAM collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
119104|NCT00655863|Secondary|Change From Baseline in Adiponectin|The change in adiponectin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||µg/mL||Standard Error|Least Squares Mean
119105|NCT00655863|Secondary|Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)|The change in hs-CRP collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg/L||Standard Error|Least Squares Mean
119106|NCT00655863|Secondary|Change From Baseline in Postprandial Proinsulin|The change in postprandial proinsulin collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||pmol/L||Standard Error|Least Squares Mean
119107|NCT00655863|Secondary|Change From Baseline in Postprandial C-Peptide|The change in postprandial C-peptide collected at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||ng/mL||Standard Error|Least Squares Mean
119108|NCT00655863|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in fasting plasma glucose collected at each week indicated relative to baseline.|Baseline, Week 4, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
119109|NCT00655863|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline, Week 8 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
119110|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||pg/mL||Standard Error|Least Squares Mean
119111|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Insulin|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||uIU/mL||Standard Error|Least Squares Mean
119112|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucose|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg/dL||Standard Error|Least Squares Mean
119113|NCT00655863|Secondary|Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)|Postprandial changes over time at each week indicated relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||pmol/L||Standard Error|Least Squares Mean
119114|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.|Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
119274|NCT00654498|Secondary|The Change From Baseline in Visual Analogue Scales (VAS)|VAS is for assessment of RLS-associated pain. The patient was asked “How severe was your RLS associated pain in legs or arms during the past week?”. No pain:0; very worst pain:10|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
119115|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.|The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.|Baseline, Week 4 and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
119116|NCT00655863|Secondary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.|The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.|Baseline and Week 4.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
119117|NCT00655863|Primary|Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.|The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.|Baseline and Week 16.|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.||mg.h/dL||Standard Error|Least Squares Mean
119118|NCT00655824|Secondary|Number of Participants With Immunoglobulin A (IgA) <0.7 Grams Per Liter (g/L) or >4 g/L, Immunoglobulin M (IgM) <0.5 g/L or >3 g/L, and Immunoglobulin G (IgG) <6.5 g/L or >16 g/L at the Indicated Time Points|Blood samples of participants were collected for the measurement of IgA, IgG, and IgM.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
119119|NCT00655824|Secondary|Number of Participants With a Positive or Negative Pregnancy Test Results.|Serum and urine pregnancy testing were performed for women of childbearing potential.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
119120|NCT00655824|Secondary|Number of Participants With Any Signs/Symptoms of Progressive Multifocal Leukoencephalopathy (PML)|"A neurological examination to detect any signs or symptoms consistent with a diagnosis of PML was conducted. Signs and symptoms of PML includ visual disturbances, ocular movements, ataxia, and changes in mental status such as disorientation or confusion. Participants with any signs/symptoms of PML on at least one visit (any visit) are included in the Yes category."|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
119121|NCT00655824|Secondary|Number of Participants With Postive or Negative Results of Testing for Anti-HBc, Anti-HBs, and HBsAG|Blood samples were collected, and participants were evaluated for serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc, and anti-HBs antibodies. Participants with positive results on at least one visit (any visit) are included in the indicated positive category. Positive test results denoted presence of the indicated parameters and Negative test results denoted absence of the indicated parameters.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 24 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
119122|NCT00655824|Secondary|Number of Participants With Postive or Negative Plasma/White Cell John Cunningham Virus (JCV) Polymerase Chain Reaction (PCR) Test Results|Blood samples were collected, and the plasma/white cell JCV PCR test was performed for qualitative analysis of plasma/white cell JCV DeoxyriboNucleic Acid (DNA). Participants with positive results on at least one visit (any visit) are included in the indicated positive category. Positive test results denoted presence of the indicated parameters and Negative test results denoted absence of the indicated parameters.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
119123|NCT00655824|Secondary|Time to CD19+ Cell Repopulation From the Time of the Last Ofatumumab Dose|Blood samples of participants were collected for the evaluation of the CD19+ B-cell subset. A participant was defined as repopulated at a visit if the CD19+ cell count was >=the lower limit of normal (LLN) or the Baseline value, whichever was lower. Time to the first repopulation relative to the last ofatumumab treatment was calculated as: (the date of the first sample where CD19+ was greater than or equal to the minimum of the LLN and the Baseline value minus the date of last dose of ofatumumab + 1) divided by 30.4375. Baseline was defined as the Baseline value from Study OFA112657.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with repopulated CD19+ cell counts were analyzed.||months||Standard Deviation|Mean
119133|NCT00655824|Secondary|Assessment of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl-transferase (GGT)|Blood samples of participants were collected for the evaluation of ALT, AST, AP, and GGT. AST, ALT, AP, and GGT are evaluated to assess the condition of the liver.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Units per liter (U/L)||Standard Deviation|Mean
119124|NCT00655824|Secondary|Time to CD19+ Repopulation Relative to Baseline|Blood samples of participants were collected for the evaluation of the CD19+ B-cell subset. A participant was defined as repopulated at a visit if the CD19+ cell count was >=the lower limit of normal (LLN) or the Baseline value, whichever was lower. Time to the first repopulation relative to Baseline was calculated as: (the date of the first sample where CD19+ was greater than or equal to the minimum of the LLN and the Baseline value minus the Baseline date + 1) divided by 365.25. Baseline was defined as the Baseline value from Study OFA112657.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with repopulated CD19+ cell counts were analyzed.||years||Standard Deviation|Mean
119125|NCT00655824|Secondary|Number of Participants With Repopulated CD19+ Cell Counts at the Indicated Time Points|Blood samples of participants were collected for the evaluation of the CD19+ B-cell subset. The number of participants with repopulated CD19+ cell counts was determined. A participant was defined as repopulated at a visit if the cell count was >=the lower limit of normal (LLN) or the Baseline value, whichever was lower. Baseline was defined as the Baseline value from Study OFA112657.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
119126|NCT00655824|Secondary|Number of Participants With Grade 3 and 4 Neutropenia Events (NEs)|Blood samples of participants were collected for the evaluation of absolute neutrophil count. A Grade 3 NE was defined as absolute neutrophil count below the following values: absolute neutrophil count <1000-500/mm^3; <1.0-0.5 x 10^9/L. A Grade 4 NE was defined as absolute neutrophil count below the following values: absolute neutrophil count <500/mm3; <0.5 x 10^9/L. Blood samples of participants were collected for the evaluation of platelet count. Grade 3 thrombocytopenia was defined as platelet counts below the following values: platelet count <50000-25000/mm^3; <50.0-25.0 x 10^9/L. Grade 4 thrombocytopenia was defined as platelet counts below the following values: platelet count <25000/mm^3; <25.0 x 10^9/L.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population||participants|||Number
119127|NCT00655824|Secondary|Number of Participants With Normal and Abnormal Electrocardiogram Readings|Electrocardiograms of the participants were taken. The abnormal clinically significant (CS) and not clinically significant (NCS) reading, as determined by the Investigator, were recorded.|8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
119128|NCT00655824|Secondary|Assessment of Lactic Dehydrogenase (LDH) and Creatine Phosphokinase (CPK)|Blood samples of participants were collected to assess LDH and CPK. Both tests are performed to evaluate the injury and damage to the body tissue, potentially from B-cell lysis.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||U/L||Standard Deviation|Mean
119129|NCT00655824|Secondary|Assessment of Body Temperature (BT)|The BT of the participants was measured BI and post the first (A) and second (B) infusions (PI) of each cycle to assess the effect of ofatumumab on the BT. The BT of the participants was measured before BI and PI A and B during all 7 treatment courses. Timing for taking BT reading: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.||Degrees celcius||Standard Deviation|Mean
119130|NCT00655824|Secondary|Assessment of Heart Rate (HR)|The HR of the participants was measured to assess the condition of the heart. HR was measured BI and post the first (A) and second (B) infusions during all 7 treatment courses. Timing for measuring HR: TC1, 3 (infu A) more than 2 hours PI; TC1, 2 ,3, 4, 7 (infu B) 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.||Beats per minute (bpm)||Standard Deviation|Mean
119131|NCT00655824|Secondary|Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The blood pressure (BP) of the participants was measured before infusion (infu) (BI) and post the first (A) and second (B) infusions (PI) during all 7 treatment courses. Timing for taking BP readings: SBP (BP when the heart is contracting): TC1, 2, 3 (infu A) more than 2 hours PI; TC1, 2 ,3 (infu B) 2 hours PI; TC4, 5, 6, 7 (infu A) 2 hours PI; TC4, 7 (infu B) 2 hours PI; TC5, 6 (infu B) 1 hour PI. For DBP (BP when the heart is resting between beats): TC1, 3 (infu A) more than 2 hours PI; TC2, 4, 5, 6, 7 (infu A) 2 hours PI; TC1, 2, 3, 4, 7 (infu A) 2 hours PI; TC5, 6 (infu B) 1 hour PI.|BI and PI A and B for all TCs (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course [up to 156 weeks, follow-up phase]). TCs were individualized based on clinical status and may not correlate to trial visits/wk|FAS Population. Only participants with data available at particular time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
119132|NCT00655824|Secondary|Assessment of Blood Urea Nitrogen (BUN)|The blood samples of participants were collected to assess the amount of nitrogen (in the form of urea) in the blood. BUN is evaluated to assess the renal function of the participants.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||millimoles per liter||Standard Deviation|Mean
119188|NCT00655564|Secondary|Safety of Alefacept Using CD4 Counts and Adverse Event Reporting|Number of participants experiencing CD4 cell counts below 250/uL or major adverse events related to treatment|52 weeks|||Participants|||Number
119134|NCT00655824|Secondary|Assessment of Total Bilirubin (TB) and Creatinine|Blood samples of participants were collected to evaluate TB and creatinine levels. TB evaluation is performed to assess the condition of the liver, and possible hemolytic anemia, and the creatinine evaluation is performed to assess the renal condition (condition of the kidneys).|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Micromoles per liter (umol/L)||Standard Deviation|Mean
119135|NCT00655824|Secondary|Assessment of Total Protein (TP) and Albumin|Blood samples of participants were collected to evaluate TP and albumin. TP can vary depending on auto-immune diseases, and TP and albumin can vary depending on debilitating diseases.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Grams/Liter (g/L)||Standard Deviation|Mean
119136|NCT00655824|Secondary|Assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, and Uric Acid|Blood samples of participants were collected for the evaluation of uric acid and electrolytes (sodium, potassium, chloride, and calcium), as increased levels may reflect B-cell lysis due to treatment with ofatumumab.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then Weeks 12 and 24 of follow-up (up to Study Wk 156). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Millimoles/liter (mmol/L)||Standard Deviation|Mean
119137|NCT00655824|Secondary|Number of Participants With Interleukin 6 (IL-6) >11.9 Picograms Per Milliliter|Blood samples of participants were collected for the evaluation of IL-6. IL-6 plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
119138|NCT00655824|Secondary|Number of Participants With B-Lymphocyte Stimulator (BLyS) >2.49 Micrograms Per Liter|Blood samples of participants were collected for the evaluation of BLyS. BLyS is a potent co-stimulator of B lymphocytes, and elevated levels of BLyS are observed in autoimmune diseases. It regulates the immunoglobin (antibody produced by B cells that is used by the immune system to identify bacteria and viruses in the body) secretion of normal B cells (type of cells in the blood).|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
119139|NCT00655824|Secondary|Number of Participants With Anti-cyclic Citrullinated Peptide Antibody (CCP) >6.9 International Units Per Liter|Blood samples of participants were collected for the evaluation of Anti-CCP. Anti-CCP plays an important role in immune response and helps assess the disease condition.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
119140|NCT00655824|Secondary|Number of Participants With Rheumatoid Factor (RA Factor) >13 International Units Per Milliliter|Blood samples of participants were collected for the evaluation of RA factor. RA factor is an antibody found in the blood of participants with rheumatoid arthritis and is used for the diagnosis of rheumatoid arthritis.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||participants|||Number
119141|NCT00655824|Secondary|Ratio of CD 4+/CD8+|Blood samples of participants were collected for the evaluation of CD4+ and CD8+ cell counts and the ratio was calculated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants with data available at particular time points were analyzed.||Ratio of CD 4+/CD8+ cells||Standard Deviation|Mean
119142|NCT00655824|Secondary|CD19+, CD4+, CD3+, and CD8+ Cell Counts, Measured in mm^3|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ cell counts. These cells are present on white blood cells and are used as markers to associate cells with immune functions. Only CD19+ cells were measured in the Follow-up Period.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||cells per millimeters cubed (mm^3)||Standard Deviation|Mean
119143|NCT00655824|Secondary|Percentage of Cluster of Differentiation (CD)19+, 4+, 3+, and 8+ B-cell Subsets in the Blood|Blood samples of participants were collected for the evaluation of CD19+, CD4+, CD3+, and CD8+ B-cell subsets. These biomarkers are associated with immune functions. Only CD19+ cells were measured in the Follow-up Period.|BL of each TC and 8 wk PI, then every 4 wk until Wk 24, then every 8 wk until next TC, then every 12 wk follow-up (up to Study Wk 204). TCs were individualized based on clinical status and may not correlate to trial visits or study wk|FAS Population. Only participants with data available at particular time points were analyzed.||Percentage of CD19+, 4+, 8+, and 3+ BCSs||Standard Deviation|Mean
119144|NCT00655824|Secondary|Whole Blood Transcriptional Profiles|Blood samples were collected for transcriptomic analysis of messenger ribonucleic acid (mRNA). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline (BL) of each TC and 8 wk post infusion (PI), then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119575|NCT00650858|Secondary|2.) 90 and 180 -Day GOS, Rankin, Stroke Impact Scale (Stage 2 Only).||90 and 180 days||||||
119145|NCT00655824|Secondary|Number of Participants With HAHA Response|The host immune response was assessed based on Human Anti-Human Antibodies (HAHA). The serum samples of the participants were collected for the assessment of HAHA. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119146|NCT00655824|Secondary|Number of Participants With the Indicated Pain Score|"The pain score was assessed using the VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the no pain end is his joint pain score. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119147|NCT00655824|Secondary|Number of Participants With the Indicated Global Disease Assessment Using the VAS|The participant and the physician independently used the VAS for overall assessment of the disease. VAS is used to measure the physician's subjective assessment of the participant's RA disease process at the time of the visit. The scale ranged from 0 (extremely well) to 10 (extremely poor). The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119148|NCT00655824|Secondary|Number of Participants in the Indicated Categories of the Health Assessment Questionnaire (HAQ)|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The index is calculated by adding all scores, then dividing this score by the total number of components answered. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119149|NCT00655824|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response|EULAR response is based on the DAS score. EULAR response criterion classifies participants as good or moderate responders and non-responders. Good response: DAS28 score <=3.2 and >1.2 improvement from Baseline (IfB) in DAS28 score, Moderate response: DAS28 score <=3.2 and between >0.6 and <=1.2 IfB; DAS28 score between >3.2 and <=5.1 and >1.2 IfB; DAS28 score between >3.2 and <=5.1 and between >0.6 and <=1.2 IfB; DAS28 score >5.1 and >1.2 IfB. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119150|NCT00655824|Secondary|Number of Participants Achieving ACR70|ACR70 is achieved if the participant has 70% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from ‘no pain’ to ‘severe pain’ and the distance marked by the participant from the “no pain” end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119151|NCT00655824|Secondary|Number of Participants Achieving ACR50|ACR50 is achieved if the participant has 50% improvement from Baseline in: TJC and SJC and in 3 out of 5 of following assessment (A) ; participant pain A , participant global A, physician global A on a visual analogue scale (VAS: a 10 cm scale ranges from ‘no pain’ to ‘severe pain’ and the distance marked by the participant from the “no pain” end is his joint pain score).and participant self-assessed disability and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated.|Baseline of each TCand 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119152|NCT00655824|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20|"ACR20 is achieved if the participant has 20% improvement from Baseline in TJC and SJC and in 3 out of 5 of following assessments (A); participant pain A, participant global A, physician global A on a visual analog scale (VAS: a 10 cm scale ranging from no pain to severe pain; the distance marked by the participant from the “no pain” end is his joint pain score), participant self-assessed disability, and C-reactive protein. The sponsor discontinued the IV administration development program for RA, and this study was terminated early; hence, this endpoint was not evaluated."|Baseline of each TC and 8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next treatment course (up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population|||||
119153|NCT00655824|Secondary|Ofatumumab Serum Concentration|Blood samples of participants were collected for the measurement of ofatumumab concentration in the blood. The blood samples were collected before infusion (BI) (baseline of that particular treatment course) and at the end of infusion (EI) of ofatumumab.|Before infusion and at the end of infusion for each Treatment Course (8 wk post infusion, then every 4 wk until Wk 24, then every 8 wk until next TC; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial vi|FAS Population. Only participants with data available at the particular time points were analyzed.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
119154|NCT00655824|Secondary|Time to Re-treatment in Each Treatment Course|Time to re-treatment in each treatment course (TC) is defined as the time from the first infusion of ofatumumab until the date of the first infusion of the first re-treatment course. The data presented reflect the time to re-treatment, which is defined as the time in days between the first infusion of each TC and the first infusion of the following TC. For TC 1, time to re-treatment is defined as the time between the first infusion in TC 1 and the first infusion in TC 2; similarly, for TC 2 it is the time between the first infusion of TC 2 and the first infusion of TC 3.|Week 16 to Week 104 of each treatment course (up to 125 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. Only participants available at the indicated time point were assessed.||days||Standard Deviation|Mean
119155|NCT00655824|Secondary|Minimum Change From Baseline in DAS28 Over the Course of Weeks 1 to 24 in Each Treatment Course, Based on C-reactive Protein (CRP)|DAS28(CRP) is a numeric outcome that measures RA activity based on the CRP (used to monitor acute inflammatory phases of RA), tender JC, swollen JC, and participant’s global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to AEs of rash and pruritis. Only participants available at the indicated time point were assessed.||scores on a scale||Standard Deviation|Mean
119156|NCT00655824|Secondary|Minimum Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) Over the Course of Weeks (Wk) 1 to 24 in Each Treatment Course (TC), Assessed by Erythrocyte Sedimentation Rate (ESR; Rate at Which Red Blood Cells Sediment in 1 Hour)|DAS28(ESR) is a numeric outcome that measures RA activity based on the ESR (a non-specific general indicator of inflammation), tender joint count (JC), swollen JC, and participant’s global assessment of disease activity on a 100 millimeter Visual Analog Scale. DAS28 values range from 0 (no activity) and upwards; increasing values indicate increasing activity (there is no upper limit on the scale). Change from baseline (CFB) was calculated at all visits; however, minimum CFB was calculated as the minimum CFB obtained over the course of weeks 1-24 of each treatment cycle.|Baseline (last visit prior to dosing in each TC) and last visit of each TC (8 wk post infusion, then every 4 wk until Wk 24; up to 144 weeks). TCs were individualized based on clinical status and may not correlate to trial visits or study weeks.|FAS Population. One participant withdrew during the first infusion due to adverse events (AEs) of rash and pruritus. Only participants available at the indicated time point were assessed. Minimum change from baseline is defined as the smallest change at any visit over the course of Weeks 1 to 24 of each treatment cycle.||scores on a scale||Standard Deviation|Mean
119157|NCT00655824|Primary|Time to Treatment Withdrawal|Time to treatment withdrawal was defined as the time from the first infusion of ofatumumab until the date of treatment withdrawal. The sponsor discontinued the intravenous route of administration development program for rheumatoid arthritis (RA), and this study was terminated early; hence, this primary endpoint was not evaluated.|From Baseline up to 144 weeks|Full Analysis Set (FAS) Population: all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment.|||||
119158|NCT00655746|Primary|Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||ng∙h/mL||Full Range|Geometric Mean
119159|NCT00655746|Primary|Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])|area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])for dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||ng∙h/mL||Full Range|Geometric Mean
119160|NCT00655746|Primary|Dasatinib PK Parameter: Plasma Half-Life (T-HALF)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=plasma half-life|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||hours||Standard Deviation|Mean
119161|NCT00655746|Primary|Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Tmax=time of maximum observed plasma concentration|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||hours||Full Range|Median
119162|NCT00655746|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)|||Participants|||Number
119163|NCT00655746|Primary|Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib|Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose|||ng/mL||Full Range|Geometric Mean
119164|NCT00655733|Secondary|Safety||12 weeks||||||
119189|NCT00655564|Primary|Efficacy of Continuous Use of Alefacept as Defined as a 75% Reduction in Psoriasis Area and Severity Index (PASI)||52 weeks|||Participants|||Number
119732|NCT00650260|Secondary|Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.|Average core body temperature measured with an esophageal probe at 60 minutes post-induction|60 minutes post anesthesia induction|||degrees celcius||Standard Deviation|Mean
119165|NCT00655733|Primary|The Efficacy of HMPL 004 Given at 1200 mg/Day, Assessed After 8 Weeks of Treatment With HMPL-004 in Inducing a Drop in the Subject's Crohn's Disease Activity Index (CDAI) by 100 Points.|For the Intention to Treat (ITT) population, the Worst Observation Carried Forward (WOCF) method, was used to measure the percentage of subjects in the HMPL 004 group as compared to the placebo group that achieved a clinical response of a CDAI reduction of 100 points at Week 8 as compared to the subject's entry level CDAI score.|8 weeks|The ITT population using the Worst Observation Carried Forward method.||% Participants|||Number
119166|NCT00655668|Secondary|Safety|Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)|Up to 24 months|Safety Population (received at least one dose of study drug)||Participants|||Number
119167|NCT00655668|Secondary|Progression-Free Survival|Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.|Up to 24 months|Intent-to-treat (ITT) Population||Months||95% Confidence Interval|Median
119168|NCT00655668|Secondary|Time-to-Progression|Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.|Up to 24 months|Due to early termination of study, data not analyzed. See outcome #4 for progression-free survival.|||||
119169|NCT00655668|Secondary|Duration of Response|Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.|Up to 24 months|Intent-to-treat (ITT) Population||Months||95% Confidence Interval|Median
119170|NCT00655668|Primary|Participants Categorized by Best Response as Determined by Investigator|"Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):~Complete Response(CR): Complete disappearance of all detectable disease~Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow~Partial Response(PR): >50% decrease in six largest nodes/nodal masses~Stable Disease(SD): Less than PR, but not progressive disease~Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites~Progressive Disease(PD): >=50% increase from low in PR/Non-Responders"|Up to 24 months|Intent-to-treat (ITT) Population||Participants|||Number
119171|NCT00655642|Primary|Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.|"Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words Least Severe on the left and Most Severe on the right. The possible values range from 0 to 100mm with 0 at the Least Severe extreme and 100 at the Most Severe extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes)."|Baseline and 30 minute assessments|Analysis was performed on all patients who received one of the four treatments and completed the 30-minute VAS assessment. The trial was anticipated to require 18 months to achieve full accrual of patients (n=600). Given that we were at 30% information fraction at 17 months, an unplanned interim analysis was done.||millimeter||Inter-Quartile Range|Median
119172|NCT00655629|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of participants|||Number
119173|NCT00655629|Secondary|Satisfaction With Medication at Week 12 or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with medication at LOCF expressed as the least square mean difference"|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.||scores on a scale||Standard Deviation|Mean
119174|NCT00655629|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Confidence for completion from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
119175|NCT00655629|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with orgasm from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
119275|NCT00654498|Secondary|The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale|RLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the intensity of tiredness and sleepiness at day.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
119176|NCT00655629|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Pleasure of sexual activity from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
119177|NCT00655629|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Erectile function satisfaction from baseline to Week 12 or LOCF expressed as the least square mean difference"|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
119178|NCT00655629|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|"Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Ease with Erection from baseline to Week 12 or LOCF expressed as the least square mean difference."|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
119179|NCT00655629|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||Sexual Attempts||Standard Deviation|Mean
119180|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of ejaculation successes||Standard Deviation|Mean
119181|NCT00655629|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of satisfactory attempts||Standard Deviation|Mean
119182|NCT00655629|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of satisfactory erections||Standard Deviation|Mean
119183|NCT00655629|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of successful erections||Standard Deviation|Mean
119184|NCT00655629|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of subjects|||Number
119185|NCT00655629|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of successful maintenance||Standard Deviation|Mean
119186|NCT00655629|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks|SEP (Sexual Encounter Profile) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||percentage of successful penetrations||Standard Deviation|Mean
119187|NCT00655629|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)|The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data||scores on a scale||Standard Deviation|Mean
119190|NCT00655551|Secondary|Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|0-4 hours post start of the infusion|||subjects|||Number
119191|NCT00655551|Primary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)|||subjects|||Number
119192|NCT00655551|Primary|Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|Treatment period (up to 7 days)|||subjects|||Number
119193|NCT00655486|Primary|Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis||subjects|||Number
119194|NCT00655486|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)|An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).|2 years|All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis||subjects|||Number
119195|NCT00655356|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119196|NCT00655356|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119197|NCT00655356|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119198|NCT00655356|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119199|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.|one week|Number of adverse events by dose and age stratum (18-24 weeks of age) are reported by system organ class and preferred term.||Adverse Events|||Number
119200|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (18-24 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.||ng||Standard Deviation|Mean
119201|NCT00655083|Secondary|Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.|Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.|one week|Number of adverse events by dose and age strata (6-<12 and 12- <18 weeks of age) are reported by system organ class and preferred term.||Adverse Events|||Number
119276|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale|RLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the activity at day.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
119202|NCT00655083|Primary|Drug Concentration Measurement in the Urine Collected by Diapers Along 24 Hours Post Dose and One Week After Dose in All Treated Infants and by Age and Dose Subgroups.|Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.|24 hours|Urinary drug concentration was analysed by dose and age stratum of the infants (6-<12 and 12- <18 weeks of age). Imputation technique was adopted for urine samples highly contaminated by faeces.||ng||Standard Deviation|Mean
119203|NCT00654992|Primary|Number of Participants Who Had AKI (Acute Kidney Injury)|number of participants who had 50% increase in serum creatinine levels from baseline|at any time within the first 5 days after surgery|||participants|||Number
119204|NCT00654992|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)|estimated glomerular filtration rate (eGFR)as ml/min/1.73m2|during the first 5 days after surgery|||ml/min/1.73m2||Standard Deviation|Mean
119205|NCT00654953|Primary|Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites|Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine.|70 days|Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis.||Days to relapse (two consec coc+ urines)|Participants|Standard Deviation|Mean
119206|NCT00654940|Secondary|Subject Activity as Captured by the Actiwatch Score Device: Total Activity Score at End of Treatment|Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined).|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS; End of Treatment is treatment week 2 (Week 2 and Week 6) for Periods 1 and 2.||scores on scale||Standard Error|Least Squares Mean
119207|NCT00654940|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI at end of treatment: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)|FAS. Weeks 0 and 4 are baseline for Periods 1 and 2, respectively. Weeks 2 and 6 are End of Treatment for Periods 1 and 2, respectively.||scores on scale||Standard Deviation|Mean
119208|NCT00654940|Primary|Change From Baseline to Treatment Week 2 in Daily Pain Rating Scale|Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period.|Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)|Full Analysis Set: (FAS): all subjects randomized who received at least one dose of study drug, regardless of whether they had efficacy data. Baseline is Week 0 and Week 4 for Periods 1 and 2, respectively. Treatment Week 2 is End of Treatment (Week 2 and Week 6) for Periods 1 and 2, respectively.||scores on scale||Standard Deviation|Mean
119209|NCT00654927|Secondary|Expanded Disability Status Scale (EDSS)|"Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death)~*EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation"|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for data missing||units on a scale||Standard Deviation|Mean
119210|NCT00654927|Secondary|Clinician Global Impression of Change (CGIC)|The CGIC was based on the Investigator’s overall impression of the patient’s neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 7 = very much worse)|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Median
119211|NCT00654927|Secondary|Subject Global Impression (SGI)|The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted)|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
119212|NCT00654927|Secondary|Timed 25 Foot Walk (T25FW)||Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit|ITT Population. No imputation for missing data||feet/second||Standard Deviation|Mean
119213|NCT00654927|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|over 7 years (2004-2011)|Safety Population. No imputation for missing data||participants|||Number
119223|NCT00654875|Primary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MADBP from baseline to the 24 hour MADBP at 6 weeks was calculated using an Analysis of covariance (ANCOVA) model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
119224|NCT00654784|Secondary|Safety and Tolerability, Assessed by Adverse Events, Blood and Urine Laboratory Measures, ECG.||1 year||||||
119214|NCT00654901|Primary|Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable."|Days 0 up to 7 after any injection|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
119215|NCT00654901|Primary|Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine|"Antibody persistence and immunogenicity response:~Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0."|Day 0 (pre-booster) and Day 30 (one month post-booster)|Antibody persistence and immunogenicity response were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per Protocol Population).||Participants|||Number
119216|NCT00654901|Primary|Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.|Day 0 (pre-booster) and Day 30 (one month post-booster)|Geometric mean titers were assessed in a subset of participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
119217|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at the End of the Study (Week 10)|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 4 (week 10).~Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 10|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 10.||Percentage of participants|||Number
119218|NCT00654875|Secondary|Percentage of Participants Achieving Blood Pressure Control at Week 6|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer. The mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure at visit 3 (week 6).~Blood pressure control was defined as having a mean sitting diastolic blood pressure (msDBP) <90 mm Hg and a mean sitting systolic blood pressure (msSBP) <140 mm Hg."|Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Week 6.||Percentage of participants|||Number
119219|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Sitting Systolic and Mean Sitting Diastolic Blood Pressure|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure. The ANCOVA model used baseline as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
119220|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP)|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 24 hour period were calculated. The difference of the 24 hour MASBP from baseline to the 24 hour MASBP at 6 weeks was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
119221|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Systolic Blood Pressure (MASBP) During the Last Three Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MASBP at baseline to the last 3 hour MASBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory systolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
119222|NCT00654875|Secondary|Change From Baseline to Week 6 in the Mean Ambulatory Diastolic Blood Pressure (MADBP) During the Last 3 Hours of the 24-hour Dosing Period|An Ambulatory Blood Pressure Monitoring (ABPM) device was attached to the non-dominant arm of the participant. The mean of Blood Pressure readings during the 22-24 hour period were calculated. The difference from the last 3 hours MADBP at baseline to the last 3 hour MADBP at Week 6 was calculated using an ANCOVA model with baseline mean 24 hour ambulatory diastolic blood pressure as a covariate.|Baseline, Week 6|Participants from the Full analysis set (consisting of all randomized patients) for whom data was available at Baseline and Week 6.||mm Hg||Standard Error|Least Squares Mean
119225|NCT00654784|Secondary|Skeletal Muscle Strength (Upper Limb, Right and Left): Hand Grip, Elbow Flexors and Elbow Extensors (Upper Limb Score) Timed Walking Test (10 Metres) (Ambulant Patients Only)||1 year||||||
119227|NCT00654784|Primary|The Relative Change in Peak Systolic Radial Strain of the Left Ventricle (LV) Inferolateral Wall From Baseline (at Screening) to Week 52, Assessed by Color Doppler Myocardial Imaging (CDMI).|"Assessing the peak systolic radial strain of the left ventricle inferolateral wall is used to characterize the cardiac involvement in the DMD patients.~Color Doppler Myocardial Imaging technique is used to quantify regional myocardial function.~The cardiac involvement in DMD is characterized by degeneration, atrophy and fibrosis of the myocardium, leading to dilated cardiomyopathy. The process begins in the posterolateral wall of the left ventricle, with septal involvement appearing at later stages."|baseline and Week 52|At Week 52, data from only 18 patients were available for the primary endpoint analysis due to missing data from 2 patients and the inability to acquire data from a 3rd patient. The efficacy comparison for the primary endpoint was conducted using the LOCF method in the ITT population. In addition, the analysis was repeated using the OC dataset.||% change in peak systolic||Standard Deviation|Mean
119228|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 18|week 0 - week 18|||participants|||Number
119229|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 15|week 0 - week 15|||participants|||Number
119230|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
119231|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 9|week 0 - week 9|||participants|||Number
119232|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 6|week 0 - week 6|||participants|||Number
119233|NCT00654745|Secondary|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3|number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 3|week 0 - week 3|||participants|||Number
119234|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
119235|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions|number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
119236|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
119237|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
119238|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
119277|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the rest at day.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
119239|NCT00654745|Secondary|Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12|number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg & <= 30 mmHg, SBP reduction > 30 mmHg & <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg & <= 15 mmHg, DBP reduction > 15 mmHg & <= 20 mmHg, DBP reduction > 20 mmHg at week 12|week 0 - week 12|||participants|||Number
119240|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18|week 0 - week 18|||participants|||Number
119241|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15|week 0 - week 15|||participants|||Number
119242|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
119243|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9|week 0 - week 9|||participants|||Number
119244|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6|week 0 - week 6|||participants|||Number
119245|NCT00654745|Secondary|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3|number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3|week 0 - week 3|||participants|||Number
119246|NCT00654745|Secondary|Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
119247|NCT00654745|Secondary|Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
119248|NCT00654745|Secondary|Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12|number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
119249|NCT00654745|Secondary|Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12|week 0 - week 12|||participants|||Number
119250|NCT00654745|Secondary|Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
119251|NCT00654745|Secondary|Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12|number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12|week 0 - week 12|||participants|||Number
119252|NCT00654745|Secondary|Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.||mm Hg||Standard Error|Mean
119253|NCT00654745|Secondary|Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks|change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.|week 0 - weeks 3, 6, 9, 12, 15, 18|Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.||mm Hg||Standard Error|Mean
119254|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment|Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)|||mm Hg||Standard Error|Mean
119255|NCT00654745|Secondary|Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment|24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP|week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)|||mm Hg||Standard Error|Mean
119256|NCT00654745|Primary|Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment|Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.|week 0 - week 12|ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.||mm Hg||Standard Error|Mean
119338|NCT00653861|Primary|Procedural Pain Score|Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
119257|NCT00654654|Primary|Independent Panel Global Improvement Assessment Compared to Baseline|An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.|Baseline (prior to treatment) compared to 6 months post last treatment|Number of patients for whom data were available||participants|||Number
119258|NCT00654654|Primary|Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment|Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.|Baseline (prior to first treatment) compared to 6 months post last treatment|Number of subjects for whom data were available from the assessment visit, 6 months after the final treatment||participants|||Number
119259|NCT00654641|Primary|Total Number of Patients Experiencing a Wound Complication|Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.|6 Weeks post-partum|||Participants|||Number
119260|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||mg/dL||Standard Deviation|Mean
119261|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Inter-Quartile Range|Median
119262|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
119263|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
119264|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline and week 12|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
119265|NCT00654628|Other Pre-specified|Mean Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||mg/dL||Standard Deviation|Mean
119266|NCT00654628|Secondary|Mean Percent Change of Triglycerides From Baseline at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Inter-Quartile Range|Median
119267|NCT00654628|Secondary|Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
119268|NCT00654628|Secondary|Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
119269|NCT00654628|Secondary|Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6||Baseline and week 6|Intention-To-Treat(ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement||Percent Change||Standard Deviation|Mean
119270|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.|Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 12|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.||Percentage of participants|||Number
119271|NCT00654628|Primary|The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.|Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level >130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol >200 mg/dl or LDL-C level >130 mg/dl.|Baseline and week 6|Intention-To-Treat (ITT) approach which included all participants who have baseline measurement, have taken at least one dose of the study drug, and have at least one post-baseline measurement.||Percentage of participants|||Number
119272|NCT00654511|Primary|Morphine Rescue|Total morphine administered in the Post Anesthesia Care Unit (PACU)|up to 24 hours|||micrograms/kilogram||Standard Deviation|Mean
119273|NCT00654511|Primary|Time to First Morphine Dose|Total minutes from study medication administration to time of first morphine dose.|up to 24 hours|||minutes||Standard Deviation|Mean
119733|NCT00650260|Primary|Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius||Intraoperative Period|||percentage of participants|||Number
119278|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 (“none/Not at all”) to 10 (“very severe”) for the severity of RLS during the night.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
119279|NCT00654498|Secondary|The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.|RLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
119280|NCT00654498|Secondary|the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales|RLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep.|Baseline and 6 weeks of treatment|||Score on a scale||Standard Deviation|Mean
119281|NCT00654498|Secondary|The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10|The ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep.|week 6 of treatment|||Proportion of Patients|||Number
119282|NCT00654498|Secondary|The Proportion of Patient Global Impression(PGI) Responders|"PGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of much better or very much better."|6 weeks of treatment|||Proportion of participants|||Number
119283|NCT00654498|Secondary|The Proportion of IRLS Responders|responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population.|6 weeks of treatment|||Proportion of Patients|||Number
119284|NCT00654498|Primary|"The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved"|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.|6 weeks of treatment|||Proportion of Patients|||Number
119285|NCT00654498|Primary|The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).|The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).|Baseline and 6 weeks of treatment|Full Analysis Set (FAS), All patients randomized, treated, having data for primary endpoint||Score on a scale||Standard Error|Least Squares Mean
119286|NCT00654420|Secondary|Phase II: Percentage of Participants With Complete Response (CR) or Partial Response (PR) After Dalotuzumab Plus Erlotinib Treatment (Objective Response Rate [ORR])|"ORR was defined as the percentage of participants in the Phase II analysis population having complete response (CR) or partial response (PR) during the course of the study.~RECIST criteria were used to quantify response rate. For evaluation of target lesions, CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. For evaluation of non-target lesions, CR was defined as disappearance of all non-target lesions and normalization of tumor marker level.~Confirmation of response required a second assessment performed 4 weeks or more after the initial assessment. If the confirmation assessment contradicted the initial assessment, it was considered that a response had not been observed. If the confirmation assessment of a participant was not available, that participant was not considered as a responder in the response rate analyses."|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for ORR.||percentage of participants||95% Confidence Interval|Number
119287|NCT00654420|Secondary|Phase II: Median Overall Survival (OS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|OS was defined as the time from randomization to death in months due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The nonparametric Kaplan-Meier method was used to estimate the survival time distribution and the median survival of each treatment group.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|Intent to Treat (IIT) Population; all randomized participants in Phase II included regardless of compliance to planned treatment. Phase I participants were not assessed for OS.||months||95% Confidence Interval|Median
119288|NCT00654420|Primary|Phase II: Median Progression Free Survival (PFS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment|PFS was defined as the time from randomization until either the emergence of radiographic evidence of disease progression or death due to any cause, whichever occurs first. Disease progression was classified as a radiographic assessment of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) using computed tomography (CT) or magnetic resonance imaging (MRI). As pre-specified by the protocol, final analysis of PFS was to take place after approximately 49 PFS events or deaths had occurred in the Phase II part of the trial. A non-parametric Kaplan-Meier method was used to estimate the median PFS time for each treatment group. Participants who discontinued from the study for reasons other than progression of disease were treated as right-censored observations at the time of the last response evaluation. Participants who withdrew from the study due to PD were considered to have a disease progression between the last visit and the time of withdrawal.|Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date)|All randomized participants in Phase II who received ≥1 dose of study treatment, had a baseline radiological (CT or MRI) disease assessment, and had ≥1 post-baseline radiological (CT or MRI) disease assessment subsequent to ≥1 dose of study treatment for reason other than discontinuation for AE. Phase I participants were not assessed for PFS.||months||95% Confidence Interval|Median
119289|NCT00654420|Primary|Phase I: Number of Participants Experiencing at Least One Dose-Limiting Toxicity (DLT) Adverse Event (AE) During the First Four Weeks of Dalotuzumab Plus Erlotinib Treatment|"A DLT was an AE related (definitely, probably, or possibly) to study therapy and occurring within first 4 weeks of therapy.~Hematologic DLTs included Grade (Gr)4 neutropenia lasting for ≥7 days, Gr 3/Gr 4 neutropenia with fever >38.5 °C and/or infection requiring antibiotic or anti-fungal treatment, and Gr 4 thrombocytopenia (25.0 x 10^9/L).~Non-hematologic DLT defined as any ≥Gr 3 nonhematologic toxicity, except Gr 3 reversible rash; Gr 3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia occurring in setting of inadequate compliance with supportive care; alopecia; anorexia; asthenia; inadequately-treated hypersensitivity reactions; Gr 3 elevated transaminases (≤1 week duration); or infusion reactions to dalotuzumab.~Any drug-related AEs that led to dose modification of dalotuzumab/erlotinib or any unresolved drug-related toxicity that caused a ≥3 week delay of next scheduled dose of study drug, regardless of Common Terminology Criteria grade, were DLTs."|Up to 4 weeks after initiation of treatment|Participants in the Phase I part of the study who received at least one dose of dalotuzumab in combination with erlotinib during the first 4 weeks of treatment and were evaluable for DLT assessment. Participants in the Phase II part of the study were not evaluated for DLTs.||participants|||Number
119290|NCT00654381|Primary|Examination of Long-term Safety of Linagliptin (52-week Treatment)|The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks|52 weeks|The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period||participants|||Number
119291|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|52 weeks|The patients who had at least one available baseline FPG measurement under the treatment with linagliptin||mg/dL||Standard Error|Least Squares Mean
119292|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward||mg/dL||Standard Error|Least Squares Mean
119293|NCT00654381|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.||mg/dL||Standard Error|Least Squares Mean
119294|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 52|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52|52 weeks|For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward||Participants|||Number
119295|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 26|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.||Participants|||Number
119296|NCT00654381|Secondary|Relative Efficacy Response of HbA1c at Week 12|HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.||Participants|||Number
119297|NCT00654381|Primary|Change From Baseline in HbA1c at Week 26|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|26 weeks|For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.||Percent||Standard Error|Least Squares Mean
119298|NCT00654381|Primary|Change From Baseline in HbA1c at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication|12 weeks|For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.||Percent||Standard Error|Least Squares Mean
119299|NCT00654368|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined by regulatory authorities as one that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|25 months|Safety Analysis Set||participants|||Number
119300|NCT00654368|Secondary|Change From Month 6 in Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication is a 14-item self-administered questionnaire which measures patients’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. Optional responses are: Extremely Dissatisfied (1), Very Dissatisfied (2), Dissatisfied (3), Somewhat Satisfied (4), Satisfied (5), Very Satisfied (6), and Extremely Satisfied (7). For each dimension, responses are added and transformed to a scale from 0 – 100, where higher scores indicate greater satisfaction. Change from Month 6 is reported for each dimension; a positive change score indicates improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF. n indicates the number of participants with available data at each time point.||scores on a scale||Standard Deviation|Mean
119389|NCT00653224|Secondary|Nasal Pruritus Score Over the Total Treatment Period (14 Days)|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal pruritus score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119301|NCT00654368|Secondary|Change From Month 6 in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. For each measure change from Month 6 is reported; a negative change score indicates improvement. End of study is month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; Work time missed and work impairment scores are only calculated for participants who were employed at the time. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
119302|NCT00654368|Secondary|Change From Month 6 in Short Form 36 Health Survey (SF-36)|"The SF-36 assesses the general quality of life (QOL) of participants by evaluating the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The questionnaire consists of 36 questions that are completed by the participant.~The SF-36 is split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.~End of study is month 24 or early termination."|Month 6, 12, 18 and 24|Intent to treat analysis set with available SF-36 data at month 6; LOCF||scores on a scale||Standard Deviation|Mean
119303|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Pain Visual Analog Scale (VAS)|The HAQ pain visual analog scale (VAS) is a measure of pain on a continuous 100 point scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 (severe pain). End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set with available data; LOCF||scores on a scale||Standard Deviation|Mean
119304|NCT00654368|Secondary|Change From Month 6 in Health Assessment Questionnaire Disability Index (HAQ DI)|The HAQ disability index is a patient-reported questionnaire specific for rheumatoid arthritis that addresses health-related quality of life. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (score=0) to 'unable to do' (score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change score indicates an improvement. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat analysis set; LOCF||scores on a scale||Standard Deviation|Mean
119305|NCT00654368|Secondary|Change From Baseline in Joint Space Narrowing|"X-rays of hands and feet were read centrally and in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (15 joints) and each foot (6 joints) on a 5-point scale scored as follows:~0 = normal; 1 = focal or doubtful; 2 = generalised, less than 50% of the original joint space; 3 = generalised, more than 50% of the original joint space or subluxation; 4 = bony ankylosis or complete luxation. The scores were summed to calculate the total JSN score ranging from 0 to 168 (worst). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.~End of study is Month 24 or early termination."|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
119306|NCT00654368|Secondary|Change From Baseline in Joint Erosion Score|X-rays of hands and feet were read centrally and in a blinded manner. Sixteen joints on each hand/wrist and 6 joints on each foot were scored for erosions on a scale of 0 to 5 (or for the feet from 0 to 10, with each side of the joint independently scored from 0 to 5) according to the following: One point is scored if erosions are discrete, rising to 2, 3, 4, or 5 depending on the amount of surface area affected (complete collapse of the bone is scored as 5). Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 280 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a Baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
119307|NCT00654368|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|The modified Total Sharp Score (mTSS) is a measure of change in joint health. X-rays of hands and feet were scored in a blinded manner by an independent reader. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (bony ankylosis or complete luxation). Erosion scores and narrowing scores were added to obtain the total mTSS score, ranging from 0 (normal) to 448 (maximal disease). An increase in mTSS from Baseline (represented by a positive change from Baseline score) indicates disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease (negative change from Baseline score) represents improvement. End of study is Month 24 or early termination.|Baseline, Month 12 and Month 24|Radiographic Analysis Set - All randomized participants with a baseline and at least 1 post baseline radiographic assessment. LOCF imputation was used.||scores on a scale||Standard Deviation|Mean
119308|NCT00654368|Secondary|Drug Persistence|Drug persistence is defined as the percentage of participants receiving etanercept at 6, 12, 18, and 24 months.|Month 6, 12, 18 and 24|Intent to Treat Analysis Set||percentage of participants|||Number
119390|NCT00653224|Secondary|Nasal Pruritus Score Over the Second Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal pruritus score over Week 2||points on a scale||Standard Deviation|Mean
125625|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Muscle Strength’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
119309|NCT00654368|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean changes in DAS28 scores from Baseline were multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity. End of study is Month 24 or early termination.|Baseline and Month 6, 12, 18 and 24|Intent to treat; LOCF. The number of participants with available data at Month 6 was 95 and 105 in each treatment group respectively.||scores on a scale||Standard Deviation|Mean
119310|NCT00654368|Secondary|Disease Activity Score (DAS) 28 Response|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. Remission is defined by a DAS28 score less than 2.6. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Moderate is defined as a DAS28 higher than 3.2 but lower than or equal to 5.1. DAS28 above 5.1 indicates high disease activity. End of study is Month 24 or early termination.|Month 6, 12, 18 and 24|Intent to treat population (all randomized participants); Last observation carried forward (LOCF) imputation was used. At Month 6 data were available for 95 and 105 participants in each treatment group respectively.||Percentage of participants||95% Confidence Interval|Number
119311|NCT00654368|Primary|Change From Month 6 to Month 12 in Disease Activity Sscore 28 (DAS28)|The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. In this study, the mean change in DAS28 scores from Month 6 to Month 12 was multiplied by a factor of -1, such that a negative change in DAS28 indicates worsening in disease activity.|Month 6 (randomization) and Month 12|The per protocol population defined as all randomized participants with DAS28 measurements both at the 6- and 12-month visit.||scores on a scale||Standard Error|Least Squares Mean
119312|NCT00654329|Secondary|Length of Stay in PACU|Total time from PACU entry until discharge|up to 24 hours|||minutes||Standard Deviation|Mean
119313|NCT00654329|Primary|Incidence of Pain|Pain greater than a zero reported in the Post Anesthesia Care Unit (PACU)|up to 24 hours|||participants|||Number
119314|NCT00654186|Secondary|Time to Disesase Progression as Measured by Radiographic Progression|Progressive disease (PD) was determined, as outlined in the protocol, by using Recist 1.0. PD is defined as greater than or equal to a 20% increase in the sum of all measureable lesions or the apprearance of two new bone lesions or the appearnce of one new soft tissue lesion.|24 months|||months||Full Range|Median
119315|NCT00654186|Secondary|Time to PSA Progression|As defined in the protocol PSA progression was an increase of at least 25%|24 months for acrual|||months||Full Range|Median
119316|NCT00654186|Primary|Number of Participants With Overall Clinical Benefit (OCB), Defined as the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Divided by the Number of Participants|"The OCB was assessed using Recist 1.0 as defined in the protocol. A CR was defined as the disappearance of all lesions. A PR was defined as > or equal to a 30% decrease in the sum of the longest diameter of measureable lesions, SD was defined < a 30% decrease in the sum of the longest diameter of measureable lesions and < a 20% increase in the sum of the longest diameter of measureable lesions. For a CR, PR or SD, there are no new lesions.~Prostate-Specific Antigen (PSA) was also evaluated. A PSA CR was a PSA < or equal to 4 ng/dl. A PSA PR was a PSA that decreased by > or equal to 50%. Stable PSA was defined as a PSA that increased >25% and decreased < 50%."|24 months for acrual|evaluable patients||percentage of patients|||Number
119317|NCT00654147|Primary|Time to Virologic Failure|time to virologic failure at week 24 (up to 48 weeks)|week 24 (up to 48 weeks)|||weeks||Standard Deviation|Median
119318|NCT00654147|Secondary|Study Medication Tolerability|study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment|date started study treatment to first week documented change study treatment up to week 48|||participants|||Number
119319|NCT00654147|Secondary|Change From Baseline CD4+ and CD8+ Cell Counts|mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms|Baseline, Weeks 16 and 24|Change from baseline compared between arms using repeated measures analysis of covariance. Linear mixed models used to accomplish these analyses.||cells/mm3||Standard Error|Mean
119320|NCT00654147|Secondary|Weeks to HIV-1 RNA <200 Copies/ml|time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml|from date of treatment start to first week documented viral suppression|||week to viral supresssion||95% Confidence Interval|Median
119321|NCT00654147|Secondary|Study Medication Toxicity-related Discontinuation .|grade 3 and grade 4 symptoms and laboratory study treatment limiting toxicity|48 weeks|||participants|||Number
119322|NCT00654147|Primary|Time to Confirmed Virologic Failure|time to confirmed viologic failure at 24 weeks (up to 48 weeks)|weeks|descriptive||weeks||95% Confidence Interval|Median
119323|NCT00654095|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.~That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.~Any adverse event that was considered treatment-related was considered an adverse reaction."|Throughout 1 year of study|||Participants|||Number
119391|NCT00653224|Secondary|Nasal Pruritus Score Over the First Week|The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal pruritus score over Week 1||points on a scale||Standard Deviation|Mean
119324|NCT00654030|Primary|Primary Outcome Measure: Immunological Response; Antigen Specific Reactions Will be Measured by IFN-ELISPOT. The ELISPOT is a Quantitative Readout of Number of T Cells That React to Specific Antigenic Stimulus.|The endpoint is immunologic response measured by IFN-ELISPOT. Increases above pre-vaccine levels (& controls) can be assessed statistically by ANOVA. Percent patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine) as well as magnitude of responses (relative ELISPOT measures) will be compared to results obtained using DC/1650 vaccine. The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.|Evaluated for 52 weeks|Per Protocol||Participants|||Number
119325|NCT00654004|Secondary|The Difference in Plasma Insulin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting insulin levels in uU/ml were measured in both groups. The differences between groups were compared with a t-test|Fasting insulin levels uUnits/ml|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. Samples were missing on one subject so 11 subjects were compared to 11 controls.||uU/ml||Standard Deviation|Mean
119326|NCT00654004|Secondary|The Difference in Plasma Leptin Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting leptin in ng/kg fat mass were measured in both groups (subjects with a long-chain fatty acid oxidation disorder; controls). The differences between groups were compared with a t-test|Fasting leptin levels ng per kg of fat mass|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.||ng/kg||Standard Deviation|Mean
119327|NCT00654004|Primary|An Outcome of This Study is the Difference in Glucose Tolerance Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|"Glucose tolerance was estimated by the Matsuda Index using glucose and insulin values from a standard oral glucose tolerance test. The Matsuda Index is calculated by the following formula: 10,000/ sq root of (fasting glucose mg/dl X fasting insulin in units/ml) X (mean glucose (mg/dl) X mean insulin (units/ml) and correlates with insulin sensitivity measured by the gold standard method of a hyperinsulinemic euglycemic clamp. Values of 2.5 or greater are considered insulin sensitive. Values of 2.4 or less are considered insulin resistance.~The Matsuda Index of Insulin Sensitivity was measured in subjects with a long-chain fatty acid oxidation disorder (n=12). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed an oral glucose tolerance test. The difference in Mastuda Index between subjects and age matched controls was compared by t-test."|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.||units on a scale||Standard Deviation|Mean
119328|NCT00654004|Secondary|The Difference in Plasma Adiponectin Levels Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Matched Controls Was Compared by T-test|Fasting total adiponectin levels in ug/ml were measured in both groups (subjects with a long-chain fatty acid oxidation disorder). The differences between groups were compared with a t-test|Fasting total adiponectin (ug/ml)|Study was designed as a one to one matching design. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects and 12 matched controls.||ug/ml||Standard Deviation|Mean
119329|NCT00654004|Primary|An Outcome of This Study is the Difference in Percent Body Fat (%BF) Between Subjects With a Long-chain Fatty Acid Oxidation Disorder and Normal Controls.|Body composition by DEXA was measured in subjects with a long-chain fatty acid oxidation disorder (n=13). Twelve age, sex and BMI matched controls and 4 heterozygotes for a long-chain fatty acid oxidation disorder were recruited who also completed body composition measures. The difference in body composition between subjects and age matched controls was compared by t-test.|Subjects will be compared to controls at one point in time.|Study design was based on 1 to 1 matching of subjects and controls. Thirteen subjects but only 12 controls completed the protocol. We report results of 12 subjects compared to 12 matched controls.||percentage of body fat||Standard Deviation|Mean
119330|NCT00653939|Secondary|Coagulation NCI-CTCAE Grade 3 or 4 (Safety Population)||Day 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population||participants|||Number
119331|NCT00653939|Secondary|Hematology NCI-CTCAE Grade 3 or 4 (Safety Population)||Days 1 (pretreatment), 7, 14, and 21 per 21-day Cycle (6 Cycles)|Safety Population||participants|||Number
119332|NCT00653939|Secondary|Chemistry NCI-CTCAE Toxicity Grade of 3 or 4 (Safety Population)||Days 1 (pretreatment) per 21-day Cycle (6 Cycles)|Safety Population||participants|||Number
119333|NCT00653939|Primary|Progression Free Survival (PFS) in the Intent-to-Treat Population|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Based on 20% increase of the longest diameter of target lesions or appearance of one or more new non-target lesions or/and progression of non-target lesions since the treatment started.|Six 21-day cycles|Intent-to-Treat||months||95% Confidence Interval|Median
119334|NCT00653939|Secondary|Overall Survival (OS) Using a Multivariate Cox Regression Model in the Intent-to-Treat Population||Until death or lost to follow-up, up to 12 months since randomization|Intent-to-Treat||Months||95% Confidence Interval|Median
119335|NCT00653939|Secondary|Best Overall Tumor Response Rate (RR) in the Intent-to-Treat Population|Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 for target lesions (assessed by MRI or CT scan): Complete Response (CR) is defined as the disappearance of all target lesions, Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, Progressive Disease is defined as at least 20% increase in the sum of the longest diameter of target lesions, Stable Disease (SD) is defined as neither shrinkage to qualify for a PR or increase to qualify for a PD.|Six 21-day cycles|Intent-to-Treat||participants|||Number
119336|NCT00653861|Secondary|Nasolabial Fold (NLF) Severity|Determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.|2 weeks|ITT||Units on a scale||Standard Deviation|Mean
119337|NCT00653861|Secondary|Comparative Pain|A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day|ITT||Percent of Participants|||Number
119339|NCT00653523|Primary|Number of Participants With Adverse Events and Adverse Reactions|"An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.~That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.~Any adverse event that was treatment-related was considered an adverse reaction."|Throughout 1 year of study|||Participants|||Number
119340|NCT00653328|Secondary|Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Weekly for 2 weeks, then monthly for 5 months|||participants|||Number
119341|NCT00653328|Secondary|Overall Survival||Date on study to date of death from any cause|All patients who received treatment. Two patients alive at last follow-up.||Months||Full Range|Median
119342|NCT00653328|Secondary|Number of Patients With Objective Response|"Patient response to treatment:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of >= 1 new lesions, and/or 2x CA-125 levels to >=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|At month 2 and monthly thereafter to cessation of treatment|Patients who were available for measurement of tumor response.One patient withdrew after beginning treatment and was not available for measurement.||participants|||Number
119343|NCT00653328|Primary|Median Time to Tumor Progression|Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level >=2x baseline and >=70 IU/ml, confirmed by a second determination at least 28 days after the first determination|Date on study to the date of measured progressive disease, every 2 cycles (2 months)|Patients available for measurement of tumor response. One patient withdrew after beginning treatment.||Months||Full Range|Median
119344|NCT00653263|Secondary|Hamilton Depression Rating Scale (HAM-D) Rating Score|Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above.|4 weeks|||"Units on a scale"||Standard Deviation|Mean
119345|NCT00653263|Primary|Methamphetamine Withdrawal Assessment (MAWA)|The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score).|Baseline through week 4|||"Units on a scale"||Standard Deviation|Mean
119346|NCT00653263|Primary|Methamphetamine Selective Severity Assessment (MSSA)|Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms.|Baseline through week 4|||"units on a scale"||Standard Deviation|Mean
119347|NCT00653224|Secondary|Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population||participants|||Number
119348|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 2|Number of participants from the ITT population with available ESS score at Week 2 and at Baseline||points on a scale||Standard Deviation|Mean
119349|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness.|Baseline and week 1|Number of participants from the ITT population with available ESS score at Week 1 and at Baseline||points on a scale||Standard Deviation|Mean
119350|NCT00653224|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period|The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available ESS score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119351|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
125626|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Deep Tendon Reflexes’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
119352|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
119353|NCT00653224|Secondary|Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 7) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
119354|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
119355|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
119356|NCT00653224|Secondary|Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 6) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
119357|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
119358|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
119359|NCT00653224|Secondary|Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 5) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
119360|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
119361|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
119362|NCT00653224|Secondary|Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 4) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
119363|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
119364|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
119365|NCT00653224|Secondary|Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 3) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
119366|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
119367|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
119368|NCT00653224|Secondary|Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 2) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
119369|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 2|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 2 and at Baseline||percent change||Standard Deviation|Mean
119370|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement.|Baseline and week 1|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Week 1 and at Baseline||percent change||Standard Deviation|Mean
119392|NCT00653224|Secondary|Nasal Congestion Score Over the Total Treatment Period (14 Days)|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available nasal congestion score over the Total Treatment period||points on a scale||Standard Deviation|Mean
120379|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 50% of Expiratory Vital Capacity (MEF50)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
119371|NCT00653224|Secondary|Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period|The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available WPAI-AS score (dimension 1) at Endpoint visit and at Baseline||percent change||Standard Deviation|Mean
119372|NCT00653224|Secondary|Global Physician’s Rating of Efficacy at Endpoint During the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population||participants|||Number
119373|NCT00653224|Secondary|Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period|"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from Marked worsening to Marked improvement."|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population||participants|||Number
119374|NCT00653224|Secondary|Ocular Redness Score Over the Total Treatment Period (14 Days)|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular redness score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119375|NCT00653224|Secondary|Ocular Redness Score Over the Second Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular redness score over Week 2||points on a scale||Standard Deviation|Mean
119376|NCT00653224|Secondary|Ocular Redness Score Over the First Week|The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular redness score over Week 1||points on a scale||Standard Deviation|Mean
119377|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular tearing/watering score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119378|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the Second Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular tearing/watering score over Week 2||points on a scale||Standard Deviation|Mean
119379|NCT00653224|Secondary|Ocular Tearing/Watering Score Over the First Week|The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular tearing/watering score over Week 1||points on a scale||Standard Deviation|Mean
119380|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular itching/burning score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119381|NCT00653224|Secondary|Ocular Itching/Burning Score Over the Second Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular itching/burning score over Week 2||points on a scale||Standard Deviation|Mean
119382|NCT00653224|Secondary|Ocular Itching/Burning Score Over the First Week|The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular itching/burning score over Week 1||points on a scale||Standard Deviation|Mean
119383|NCT00653224|Secondary|Ocular Pruritus Score Over the Total Treatment Period (14 Days)|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available ocular pruritus score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119384|NCT00653224|Secondary|Ocular Pruritus Score Over the Second Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available ocular pruritus score over Week 2||points on a scale||Standard Deviation|Mean
119385|NCT00653224|Secondary|Ocular Pruritus Score Over the First Week|The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available ocular pruritus score over Week 1||points on a scale||Standard Deviation|Mean
119386|NCT00653224|Secondary|Post-nasal Drip Score Over the Total Treatment Period (14 Days)|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available post-nasal drip score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119387|NCT00653224|Secondary|Post-nasal Drip Score Over the Second Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available post-nasal drip score over Week 2||points on a scale||Standard Deviation|Mean
119388|NCT00653224|Secondary|Post-nasal Drip Score Over the First Week|The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available post-nasal drip score over Week 1||points on a scale||Standard Deviation|Mean
125627|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Mental Status’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
119393|NCT00653224|Secondary|Nasal Congestion Score Over the Second Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available nasal congestion score over Week 2||points on a scale||Standard Deviation|Mean
119394|NCT00653224|Secondary|Nasal Congestion Score Over the First Week|The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available nasal congestion score over Week 1||points on a scale||Standard Deviation|Mean
119395|NCT00653224|Secondary|Rhinorrhea Score Over the Total Treatment Period (14 Days)|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available rhinorrhea score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119396|NCT00653224|Secondary|Rhinorrhea Score Over the Second Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available rhinorrhea score over Week 2||points on a scale||Standard Deviation|Mean
119397|NCT00653224|Secondary|Rhinorrhea Score Over the First Week|The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available rhinorrhea score over Week 1||points on a scale||Standard Deviation|Mean
119398|NCT00653224|Secondary|Sneezing Score Over the Total Treatment Period (14 Days)|The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available sneezing score over the Total Treatment period||points on a scale||Standard Deviation|Mean
119399|NCT00653224|Secondary|Sneezing Score Over the Second Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available sneezing score over Week 2||points on a scale||Standard Deviation|Mean
119400|NCT00653224|Secondary|Sneezing Score Over the First Week|The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available sneezing score over Week 1||points on a scale||Standard Deviation|Mean
119401|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TOSS over the Total Treatment period||points on a scale||Standard Deviation|Mean
119402|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the Second Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TOSS over Week 2||points on a scale||Standard Deviation|Mean
119403|NCT00653224|Secondary|Total Ocular Symptom Score (TOSS) Over the First Week|Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TOSS over Week 1||points on a scale||Standard Deviation|Mean
119404|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available TNSS over the Total Treatment period||points on a scale||Standard Deviation|Mean
119405|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the Second Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available TNSS over Week 2||points on a scale||Standard Deviation|Mean
119406|NCT00653224|Secondary|Total Nasal Symptom Score (TNSS) Over the First Week|Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available TNSS over Week 1||points on a scale||Standard Deviation|Mean
119407|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided.|Over total treatment period (14 days)|Number of participants from the ITT population with available T4SS over the Total Treatment period||points on a scale||Standard Deviation|Mean
119408|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the Second Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T4SS over Week 2||points on a scale||Standard Deviation|Mean
119409|NCT00653224|Secondary|Total 4 Symptoms Score (T4SS) Over the First Week|Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided.|Over week 1|Number of participants from the ITT population with available T4SS over Week 1||points on a scale||Standard Deviation|Mean
120636|NCT00637728|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
119410|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the Second Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided.|Over week 2|Number of participants from the ITT population with available T5SS over Week 2||points on a scale||Standard Deviation|Mean
119411|NCT00653224|Secondary|Total 5 Symptoms Score (T5SS) Over the First Week|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided.|Over week 1|Number of participants from the ITT population with available T5SS over Week 1||points on a scale||Standard Deviation|Mean
119412|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ emotional score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119413|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ emotional score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119414|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ emotional score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119415|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119416|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ eye symptoms score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119417|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ eye symptoms score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119418|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119419|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ nasal symptoms score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119420|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ nasal symptoms score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119421|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ practical problems score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119576|NCT00650858|Primary|Rate of Symptomatic Bleeding Events|The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.|30-days|||participants|||Number
119422|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ practical problems score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119423|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ practical problems score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119424|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119425|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119426|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ non-nose/eye symptoms score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119427|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ sleep score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119428|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ sleep score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119429|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ sleep score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119430|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 2|Number of participants from the ITT population with available RQLQ activities score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119431|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated.|Baseline and week 1|Number of participants from the ITT population with available RQLQ activities score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119432|NCT00653224|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available RQLQ activities score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119452|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination SAEs|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~* Grade 3 SAEs were not assessed."|Throughout the safety follow-up (month 7 up to Month 12).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119433|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 2|Number of participants from the ITT population with available overall RQLQ score at Visit 4 (Week 2) and at Baseline||points on a scale||Standard Deviation|Mean
119434|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6.|Baseline and week 1|Number of participants from the ITT population with available RQLQ overall score at Visit 3 (Week 1) and at Baseline||points on a scale||Standard Deviation|Mean
119435|NCT00653224|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period.|Baseline and at endpoint of the 2 week treatment period|Number of participants from the ITT population with available overall RQLQ score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
119436|NCT00653224|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent to treat (ITT) population with available T5SS over the Total Treatment Period||points on a scale||Standard Deviation|Mean
119437|NCT00652145|Secondary|Fecal Calprotectin <200 µg/g||at 6 weeks after randomization|25 participants with baseline FC>=200ug/g||participants|||Number
119438|NCT00652145|Secondary|Fecal Calprotectin Level <100 µg/g||at 6 weeks after randomization|38 participants with baseline FC>=100ug/g||participants|||Number
119439|NCT00652145|Primary|Fecal Calprotectin Level <50µg/g||6 weeks after randomization|||participants|||Number
119440|NCT00653159|Secondary|Device Satisfaction Rates|"Satisfaction rate is the proportion of subjects who report being happy or very happy with their assigned intrauterine contraceptive method on the date of their 6 month study visit."|6 months|Only subjects who were not lost to follow-up at 6 months were included in this analysis.||percentage of subjects completing study|||Number
119441|NCT00653159|Secondary|Expulsion Rates|Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
119442|NCT00653159|Secondary|Pregnancy Rates|Proportion of subjects who became pregnant within 6 months of IUD insertion|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
119443|NCT00653159|Secondary|Heavy Bleeding Rates|Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
119444|NCT00653159|Primary|Retention Rate|Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)|6 months|All study participants were included in the analysis.||percentage of randomized subjects|||Number
119445|NCT00653133|Primary|Complications of Peripheral Nerve Block|Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic|Preoperative through 3 days post operative|Intent to treat (ITT)||participants|||Number
119446|NCT00653068|Secondary|Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy|The number of patients that experience CTC Version 4 grade 3 or higher during protocol therapy|During and after completion of study treatment|68 eligible patients were evaluable||patients|||Number
119447|NCT00653068|Primary|Toxic Death|Toxic death is defined to be death primarily attributable to complications of treatment.|During and after completion of study treatment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.||Patients|||Number
119448|NCT00653068|Primary|Overall Survival (OS)|Time to death from any cause.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.||Estimated Probability||95% Confidence Interval|Number
119449|NCT00653068|Primary|Event-free Survival|Time to disease progression, disease relapse, occurrence of a second malignant neoplasm, or death from any cause.|Up to 4 years after study enrollment|One patient was ineligible in stratum I and one patient was ineligible in stratum III. There were no patients enrolled in Stratum 2 or 4.||Estimated probability||95% Confidence Interval|Number
119450|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the safety follow-up (month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119451|NCT00652938|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119453|NCT00652938|Secondary|Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Related SAEs were SAEs assessed by the investigators as related to the vaccination.~* Grade 3 SAEs were not assessed."|Throughout the active phase of the study (up to Month 7).|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119454|NCT00652938|Secondary|Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination."|During the 30-day period (Days 0 - 29) following any vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119455|NCT00652938|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119456|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity.~Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas."|During the 7-day (Days 0-6) period following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119457|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|"Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.~Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination."|During the 7-day (Days 0-6) period following vaccination.|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119458|NCT00652938|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms include injection site pain, redness and swelling.~Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm."|During the 7-day period (Days 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119459|NCT00652938|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|"Solicited local symptoms included injection site pain, redness and swelling.~Any solicited local symptom is occurence of a symptom regardless of its intensity."|During the 7-day period (Days 0 - 6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
119460|NCT00652938|Secondary|Anti-HBs Antibody Titers|"Anti-HBs antibody titers are given as GMTs in mIU/mL.~Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
119461|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination.~Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
119462|NCT00652938|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.~Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
119463|NCT00652938|Secondary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).~Only groups which had received the HPV vaccine were included in the analysis.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
119464|NCT00652938|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.~Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 2|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
119465|NCT00652938|Secondary|Anti-HBs Antibody Titres|"Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL.~Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
119466|NCT00652938|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.~Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
119467|NCT00652938|Primary|Anti-HPV-16/18 Antibody Titres|"Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).~Only groups which had received the HPV vaccine were included in the analysis.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
119468|NCT00652938|Primary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion|"Only groups which had received the HPV vaccine were included in the analysis.~Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.~Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
119469|NCT00652938|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection|"Only groups which had received the HBV vaccine were included in the analysis.~Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination.~Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL."|Month 7|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.||subjects|||Number
119470|NCT00652899|Secondary|Median Overall Survival Number of Days Patients Alive After Treatment|Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.|From first date on-study (treatment) to date of death|||Days||95% Confidence Interval|Median
119471|NCT00652899|Secondary|Median Number of Days to Progression|Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) > or = 20% increase in sum of all target or any new lesions.|From date of first treatment to disease progression|||Days||95% Confidence Interval|Median
119472|NCT00652899|Secondary|Number of Patients Per Disease Response|Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- < or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of < or = 1 new lesion.|1 Month After Natural Killer Cell Infusion (Day 30)|Includes 12 patients that completed treatment per protocol criteria.||Patients|||Number
119473|NCT00652899|Primary|Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product|Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.|Day 12-14|||Patients|||Number
119474|NCT00652834|Primary|GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score|"The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.~A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms."|one month|||GSRS score||95% Confidence Interval|Mean
119475|NCT00652626|Primary|Number of Participants With Adverse Events (AEs)|"A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:~Results in death;~Is life threatening;~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Is medically important.~The Investigator assessed each AE for potential causal relationship between the event and study drug.~The intensity of adverse changes in physical signs or symptoms was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3, and according to the following: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3), Life threatening (Grade 4), or Death (Grade 5)."|Initial treatment phase: Days 1-11 for participants who received a single dose; Days 1-29 for participants who received multiple doses. Extension treatment period: From the date of first dose until 28 days after the date of last dose (up to 7 months).|Safety population, all enrolled patients who received at least one dose of azacitidine and who had at least one post-treatment safety assessment.||participants|||Number
119485|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F)|The apparent total clearance of azacitidine after a single dose on Day 1, calculated as Dose/AUC0-inf.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
119476|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F) After Single and Multiple Doses of Azacitidine|The apparent volume of distribution of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||liters||Geometric Coefficient of Variation|Geometric Mean
119477|NCT00652626|Primary|Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine|The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||liters/hour||Geometric Coefficient of Variation|Geometric Mean
119478|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½) After Single and Multiple Doses of Azacitidine|The terminal phase half-life of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||hours||Geometric Coefficient of Variation|Geometric Mean
119479|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax) After Single and Multiple Doses of Azacitidine|The time to first maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||hours||Full Range|Median
119480|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax) After Single and Multiple Doses of Azacitidine|The maximum observed plasma concentration of azacitidine after a single dose (Day 1) or multiple doses (Day 5) for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
119481|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity After Single and Multiple Doses of Azacitidine|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine, after a single dose (Day 1) and multiple doses (Day 5), calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:~AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
119482|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Time Point After Single and Multiple Doses of Azacitidine|The area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule for participants with normal renal function and for participants with severe renal impairment.|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
119483|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose After Single and Multiple Doses of Azacitidine|"The effect of renal impairment on azacitidine pharmacokinetics was analyzed by comparing PK parameters obtained on Days 1 and 5 from participants with severe renal impairment and those with normal renal function.~Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose (Day 1) and multiple doses (Day 5) was calculated by the linear trapezoidal rule."|Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
119484|NCT00652626|Primary|Apparent Volume of Distribution of Azacitidine (Vz/F)|The apparent volume of distribution of azacitidine after a single dose on Day 1, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz)|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||liters||Geometric Coefficient of Variation|Geometric Mean
119554|NCT00651313|Secondary|Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing||7 hours following fourth dose in 2 consecutive menstrual cycles||||||
119555|NCT00651313|Primary|Treatment-emgergent Adverse Events||approximately two months, based on onset of menses||||||
119486|NCT00652626|Primary|Terminal Phase Half-life of Azacitidine (t½)|The terminal phase half-life of azacitidine after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||hours||Geometric Coefficient of Variation|Geometric Mean
119487|NCT00652626|Primary|Time to Maximum Plasma Concentration of Azacitidine (Tmax)|The time to first maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||hours||Full Range|Median
119488|NCT00652626|Primary|Maximum Plasma Concentration of Azacitidine (Cmax)|The maximum observed plasma concentration of azacitidine after a single dose on Day 1.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
119489|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|"The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for azacitidine after a single dose, calculated by the linear trapezoidal rule and extrapolated to infinity according to the following equation:~AUC0-inf = AUC0-t + (Ct/ke), where Ct is the last quantifiable concentration and ke = elimination rate constant."|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
119490|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point|Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
119491|NCT00652626|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose|Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.|Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
119492|NCT00652366|Secondary|PFS Assessed From the Start of 4-Week Run-In|PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS; only participants with an event of PD or death were included in the analysis.||weeks||95% Confidence Interval|Median
119493|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In|PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.|FAS||percentage of participants|||Number
119494|NCT00652366|Secondary|OS Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology.|BL and weekly thereafter for up to 46 months.|FAS||months||95% Confidence Interval|Median
119495|NCT00652366|Secondary|Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In|OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|BL and weekly thereafter for up to 46 months.|FAS||percentage of participants|||Number
119496|NCT00652366|Secondary|Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST|Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS||percentage of participants||95% Confidence Interval|Number
119497|NCT00652366|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST|CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS||percentage of participants||95% Confidence Interval|Number
119498|NCT00652366|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST|BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method.|BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.|FAS||percentage of participants||95% Confidence Interval|Number
119499|NCT00652366|Secondary|PFS Assessed From Point of Randomization|PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS||weeks||95% Confidence Interval|Median
119500|NCT00652366|Secondary|Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization|Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS||percentage of participants|||Number
119501|NCT00652366|Primary|OS Assessed From Point of Randomization|OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|FAS||months||95% Confidence Interval|Median
119502|NCT00652366|Primary|Percentage of Participants Who Died Assessed From Point of Randomization|Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.|Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.|Full analysis set (FAS): all randomized participants.||percentage of participants|||Number
119503|NCT00652340|Secondary|Overall Survival||Randomization and every cycle|||months||95% Confidence Interval|Median
119504|NCT00652340|Primary|Time to Disease Progression (TDP)||Baseline and every other cycle.|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.13 between the proportions of patients who are progression free in AP/E (0.34) and P/E (0.21) after 5 months; an overall sample size of 115 patients (77 in AP/E and 38 in P/E) will be randomized in a 2:1 ratio in this study.||months||95% Confidence Interval|Median
119505|NCT00652327|Primary|Percentage Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline at Study Endpoint, After 8 Weeks of Treatment||Assessed at the end of 8 weeks of treatment (from baseline to endpoint)|The population analyzed (intent-to-treat [ITT]) included all participants who had a post-randomization LDL-C laboratory evaluation. As such, 20 of the 83 participants who received treatment assignment were excluded from the ITT. The 5 participants who discontinued were included in the ITT as each had a post-randomization LDL-C lab evaluation.||Percentage change||Standard Deviation|Mean
119506|NCT00652314|Secondary|Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters||0 day, 30 day, and 60 days post procedure|||participants|||Number
119507|NCT00652314|Secondary|Safety: Incidence Rate of Device-related Adverse Events||Procedure, up to 60 days post procedure|||participants|||Number
119508|NCT00652314|Secondary|Effectiveness: Hemostatic Handling Characteristics (Surgeon’s Questionnaire)|Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics.|Procedure (application through end of procedure)|Note that the number of participants analyzed (62 and 33) applies to each set of five rows below which apply to the following categories: Ease of application to bleeding site, conformance to tissue surfaces, ease of delivery to hard to reach surfaces, and ease of preparation for use.||participants|||Number
119509|NCT00652314|Secondary|Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment)||Procedure, up to 6 minutes post procedure|||participants|||Number
119510|NCT00652314|Primary|The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings.|Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.|Time to hemostasis (minutes)|||Time to hemostasis (minutes)||Standard Deviation|Mean
119511|NCT00652093|Secondary|Final Pain|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
119556|NCT00651313|Primary|The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale.||Two 4-day dosing regimens for two consecutive monthy menstrual cycles|Time-weighted average pain intensity over the 4 treatment days using the 4 point categorical scale - none (0), mild (1), moderate (2), and severe (3); primary efficacy variable. ITT Analysis Set.||units on a scale||Standard Deviation|Mean
119557|NCT00651261|Secondary|DFS Rate One Year After Completing the Planned Continuation Phase||30 months||||||
119512|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
119513|NCT00652093|Secondary|Swiss Spinal Stenosis Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|study visit|||units on a scale||Standard Deviation|Mean
119514|NCT00652093|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
119515|NCT00652093|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
119516|NCT00652093|Secondary|Roland Morris Disability Questionnaire (RMDQ)|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
119517|NCT00652093|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
119518|NCT00652093|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
119519|NCT00652093|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||minutes||Standard Deviation|Mean
119520|NCT00652093|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||meters||Standard Deviation|Mean
119521|NCT00652093|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.|study visit|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale * minutes||Standard Deviation|Mean
119522|NCT00652093|Primary|Time to First Symptoms (Tfirst) of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.|study visit|The analyses included all 24 enrolled randomized subjects based on inclusion/exclusion criteria except for three who withdrew from trial prior to completion of study. One dropped out (physician decision) due to an adverse event (AE) (dizzy) and two dropped due to scheduling. This singular AE is not included in the AE reporting below.||minutes||Standard Deviation|Mean
119523|NCT00652028|Primary|Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl)|Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period|During the treatment period (Approximately 24 hours)|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||participants|||Number
119558|NCT00651261|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR.|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
119524|NCT00652028|Primary|Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score|"RSS Score range from 1 to 6:~Patient is anxious and agitated or restless, or both.~Patient is cooperative, orientated and tranquil.~Patient responds to command only.~Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus.~Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.~Patient exhibits no response to stimulus."|Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||units on a scale||Standard Deviation|Mean
119525|NCT00652028|Primary|Clearance (CL)|Clearance (CL) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||Litre/hour||Standard Deviation|Mean
119526|NCT00652028|Primary|Volume of Steady State Distribution (Vss)|Volume of steady state distribution (Vss) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||Litre||Standard Deviation|Mean
119527|NCT00652028|Primary|Plasma Concentration at Steady State (Css)|Plasma concentration at steady state (Css) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||picograms per milliliter||Standard Deviation|Mean
119528|NCT00652028|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life (t1/2) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||hour||Standard Deviation|Mean
119529|NCT00652028|Primary|Observed Peak Plasma Concentration|Observed peak plasma concentration (Cmax) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||picograms per milliliter||Standard Deviation|Mean
119530|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞)|Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine|≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.||picograms*hr/mL||Standard Deviation|Mean
119531|NCT00652028|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t)|Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine|≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.|Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for pharmacokinetic (PK) and pharmacodynamic (PD) analyses.||picograms*hr/mL||Standard Deviation|Mean
119532|NCT00651924|Primary|Comprehension|Each treatment session had 5 True / False questions that corresponded with the material in the patient handbook. Phase 1 participants reviewed individual treatment modules in the patient handbook to provide immediate feedback regarding how understandable, engaging, and informative they find the materials. Phase 2 participants’ used the patient materials as part of treatment and the true/false questions were used to evaluate comprehension of the materials. Example questions: Chronic pain can affect how you feel physically and emotionally (T); Relaxation is the same as being lazy and unproductive (F).|Immediately after review of materials (phase 1); 1 week post review of materials (phase 2)|Per protocol||Percent of questions answered correctly||Standard Deviation|Mean
119533|NCT00651820|Secondary|Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle|Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.|9 Months|Analysis performed on Intent-to-Treat (ITT) population||mmHg/mm|Participants|Standard Deviation|Mean
119534|NCT00651820|Primary|Time to Complete Wound Closure Collagenase Santyl and Vehicle||21 days|Analysis was performed on all subjects as intent-to-treat (ITT).||Days|Participants|95% Confidence Interval|Mean
119559|NCT00651261|Secondary|Complete Response Rate|Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60.|Induction therapy (up to 60 days)|||percentage of participants||95% Confidence Interval|Number
119535|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Prednisolone (PL), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PL, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.||ng/mL*hr||90% Confidence Interval|Geometric Mean
119536|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte,Prednisone (PR), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of PR, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 8 hours of cyclophosphamide infusion for both cycles (21 day cycle)|Per protocol, 18 participants were eligible for PK analysis.||ng/mL*hr||90% Confidence Interval|Geometric Mean
119537|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Vincristine (VC), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of VC, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. nanograms (ng)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 patients eligible for PK analysis, two participants were excluded from the analysis due to data issues.||ng/mL*hr||90% Confidence Interval|Geometric Mean
119538|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 4-hydroxy-cyclophosphamide (4-OH-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 4-hydroxy-cyclophosphamide (4-OH-CP), during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.||ug/mL*hr||90% Confidence Interval|Geometric Mean
119539|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, 2-dechloro-cyclophosphamide(2-deCI-CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of 2-deCI-CP, during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.||ug/mL*hr||90% Confidence Interval|Geometric Mean
119540|NCT00651755|Primary|Geometric Mean Area Under Curve (AUC) of Analyte, Cyclophosphamide (CP), in Aprepitant Treatment and Control Group|Pharmacokinetic (PK) blood sampling to determine the geometric mean AUC of Cyclophosphamide (CP) during & post chemotherapy infusion, baseline, at 30, 60, 75, 90 minutes, and 2 , 4, 6, 8, and 24 hours from start of cyclophosphamide infusion. The absence of PK drug interactions was determined if the 90% Confidence Intervals (CI) of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25. Measurements reported as concentrate times the time, i.e. micrograms (ug)/milliliters (mL) times hour (hr).|Time points over 24 hours of cyclophosphamide infusion for both cycles (21 day cycle)|There were 18 participants eligible for PK analysis, one was excluded from the final analysis due to data issues.||ug/mL*hr||90% Confidence Interval|Geometric Mean
119541|NCT00651625|Secondary|Physician Satisfaction|"0- 10 cm visual analogue satisfaction scale (VASS)~0-10 cm VASS at 2 weeks compared to 0-10 cm VASS pain scale at 0 weeks where 0= completely dissatisfied, and 10 = completely satsified. The difference (2 week VAS-0 week VAS) is the outcome measure"|during procedure|||cm||Standard Deviation|Mean
119542|NCT00651625|Secondary|Adverse Outcomes (Hemorrhage, Infection, Hematoma, Extravasation)||during procedure, 2 weeks afterwards, and 6 months afterwards|||participants|||Number
119543|NCT00651625|Secondary|Aspirated Fluid Volume|Aspirated fluid volume during procedure|during procedure|||ml||Standard Deviation|Mean
119544|NCT00651625|Primary|Pain Using VAS (Visual Analogue Pain Scale)|0-10 cm VAS pain scale at 2 weeks compared to 0-10 cm VAS pain scale at 0 weeks where 0= no pain, and 10 = the worst pain imaginable. The difference (2 week VAS-0 week VAS) is the primary outcome measure.|2 weeks|||cm||Standard Deviation|Mean
119545|NCT00651482|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) per RECIST criteria|24 months|||months||Full Range|Median
119546|NCT00651482|Secondary|Treatment Discontinuation Due to Disease Progression|Number of subjects whose treatment was discontinued due to disease progression|24 months|||participants|||Number
119547|NCT00651482|Secondary|Treatment Discontinuation Due to Toxicity|Number of subjects whose treatment was discontinued due to toxicity|24 months|||participants|||Number
119548|NCT00651482|Secondary|Total Number of Drug-related SAEs||24 months|||events|||Number
119549|NCT00651482|Secondary|Number of Subjects With Drug-related SAEs||24 months|||participants|||Number
119550|NCT00651482|Secondary|Overall Survival (OS)||44 months|||months||Full Range|Median
119551|NCT00651482|Secondary|Time-to-Treatment Failure (TTF)||24 months|||months||Full Range|Median
119552|NCT00651482|Secondary|Objective Response (OR) Duration||24 months|||weeks||Full Range|Median
119553|NCT00651482|Secondary|Objective Response (OR)|Number of subjects with objective response (OR)|24 months|||participants|||Number
119560|NCT00651261|Secondary|Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant|Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
119561|NCT00651261|Secondary|Event- Free Survival|"Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.~Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint."|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
119562|NCT00651261|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (Up to 10 years)|||months||95% Confidence Interval|Median
119563|NCT00651183|Primary|Change From Baseline in UPDRS Part III (Motor Examination)|14 components rating scale with 27 items scored by 0 (none) - 4 (severe)|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
119564|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
119565|NCT00651183|Primary|Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.~It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale."|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
119566|NCT00651183|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)|"Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement.~Total UPDRS part I score ranges from 0 = best score to 16 = worst score"|Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)|Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis||Points on a scale||Inter-Quartile Range|Median
119567|NCT00651157|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to documentation of disease progression, assessed up to 5 years|||days||95% Confidence Interval|Median
119568|NCT00651157|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 5 years|||months||95% Confidence Interval|Median
119569|NCT00651157|Primary|Tumor Response|"A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Every 4 weeks after 4 courses of treatment, assessed up to 5 years|||participants|||Number
119570|NCT00651118|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days|"adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.~The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result."|day 1 to day 14|intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
119571|NCT00651118|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result."|day 1 to day 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
119572|NCT00651118|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result."|days 1 to 14|intent to treat population (ITT)- must have had at least one post baseline efficacy assessment||units on a scale||Standard Deviation|Least Squares Mean
119577|NCT00650858|Primary|Incidence of Bacterial Ventriculitis, Meningitis|The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.|30 days|||Number of participants|||Number
119578|NCT00650858|Secondary|1.) Rate of Clot Size Reduction at Days 4-5 Determined by CT Scans (Stages 1 and 2).||180 days||||||
119579|NCT00650858|Primary|30-day Mortality|The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.|30 days|||Number of participants|||Number
119580|NCT00650845|Secondary|eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population|eGFR (estimated Glomerular Filtration Rate) was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and a post- procedure blood sample for creatinine measurements) deprived of patients with protocol deviations/violations.||Percentage of change from baseline||Standard Deviation|Mean
119581|NCT00650845|Secondary|Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population|eGFR was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.|Baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and a post-procedure blood sample for creatinine measurements.||Percentage of change from baseline||Standard Deviation|Mean
119582|NCT00650845|Secondary|Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Per protocol population. This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.||Percentage of change from baseline||Standard Deviation|Mean
119583|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|Baseline pre MRI and 3 days post MRI|Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.||Number of patients|||Number
119584|NCT00650845|Secondary|Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.|Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.|Baseline pre MRI and 3 days post MRI|Full analysis set population:all included patients with a pre and post-procedure blood sample for creatinine measurement.||Percentage of change from baseline||Standard Deviation|Mean
119585|NCT00650845|Primary|Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.|Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.|baseline pre MRI and 3 days post MRI|Full analysis set population: all included patients with a pre and post-procedure blood sample for creatinine measures.||Number of patients|||Number
119586|NCT00650806|Secondary|Change in Waist/Hip Ratio From Baseline to Week 12|The table below shows the mean change in waist/hip ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||ratio||Standard Deviation|Mean
119587|NCT00650806|Secondary|Change in Hip Circumference From Baseline to Week 12|The table below shows the mean change in hip circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||cm||Standard Deviation|Mean
119588|NCT00650806|Secondary|Change in Waist Circumference From Baseline to Week 12|The table below shows the mean change in waist circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||cm||Standard Deviation|Mean
119729|NCT00650260|Primary|Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.||Temp taken just prior to surgery|Per protocol, sample size calculations indicate that a total sample size of 42 patients will be necessary to evaluate the primary outcome at an adjusted alpha = 0.05 with 80% power.||Percentage of participants|||Number
119730|NCT00650260|Secondary|Median Post Anesthesia Care Unit Sublingual Temperature||Upon arrival to the post anesthesia care unit|||Degrees Celcius||Full Range|Median
119589|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
119590|NCT00650806|Secondary|Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12|The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percentage of patients|||Number
119591|NCT00650806|Secondary|Change in Body Mass Index (BMI) From Baseline to Week 12|The table below shows the mean change in BMI from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||kg/m2||Standard Deviation|Mean
119592|NCT00650806|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||kg||Standard Deviation|Mean
119593|NCT00650806|Primary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Deviation|Mean
119594|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119595|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119596|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119604|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119597|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119598|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119599|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119600|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119601|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119602|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119603|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score|SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119651|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 16 (Follow-up)||Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
119605|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119606|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119607|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119608|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119609|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119610|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119611|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119612|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119613|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119652|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 12||Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
119653|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 8||Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
119614|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119615|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119616|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119617|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119618|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119619|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119620|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119621|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119622|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119654|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 4||Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
119655|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 2||Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
119623|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119624|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119625|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119626|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119627|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119628|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119629|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119630|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119631|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119656|NCT00650767|Secondary|C-Reactive Protein (CRP) at Week 1||Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
119657|NCT00650767|Secondary|C-Reactive Protein (CRP) at Baseline||Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||mg/dL||Standard Deviation|Mean
119632|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119633|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119634|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119635|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119636|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119637|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119638|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119639|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119640|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119683|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119641|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119642|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119643|NCT00650767|Secondary|SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning|"The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.~The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119644|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119645|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119646|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119647|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119648|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119649|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119650|NCT00650767|Secondary|Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])|The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119658|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119659|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119660|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119661|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119662|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119663|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to “without difficulty,” 1 equal to “with some difficulty,” 2 equal to “with much difficulty” and 3 equal to “unable to do.” Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119684|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119685|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119664|NCT00650767|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI)|"The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to without difficulty, 1 equal to with some difficulty, 2 equal to with much difficulty and 3 equal to unable to do. Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.~The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119665|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119666|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119667|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119668|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119669|NCT00650767|Secondary|Physician’s Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119670|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician’s response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119671|NCT00650767|Secondary|Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).~The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119672|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119673|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119674|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119675|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119676|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119677|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient’s Global Assessment of Arthritis was an evaluation based on the patient’s disease signs, functional capacity and physical examination, and was independent of the Physician’s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: “Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing.” The patient’s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119678|NCT00650767|Secondary|Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)|"The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).~Patients answered the following: Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing. The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly)."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119679|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119680|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119681|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119682|NCT00650767|Secondary|Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)|The Patient’s Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119686|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119687|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119688|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119689|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119690|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119691|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119692|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119693|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119694|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119695|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119726|NCT00650546|Primary|Change in NAS|The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease.|Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.|||units on a scale||Standard Deviation|Mean
119731|NCT00650260|Secondary|Average Intraoperative Esophageal Temperature|Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia.|Intraoperative 0-70 minutes|||Degrees Celcius||Full Range|Mean
119696|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119697|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119698|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119699|NCT00650767|Secondary|American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness."|Baseline|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||units on a scale||Standard Deviation|Mean
119700|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119701|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119702|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119703|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119704|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119705|NCT00650767|Secondary|American College of Rheumatology 70% (ACR70) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119727|NCT00650546|Primary|Number of Patients With Improvement in Liver Histology After Treatment With Exenatide|Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS<3.|between baseline and 24-28 weeks after initiating treatment|||participants|||Number
119706|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119707|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119708|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119709|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119710|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119711|NCT00650767|Secondary|American College of Rheumatology 50% (ACR50) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119712|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 16 (Follow-up)|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119713|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 8|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 8|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119714|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 4|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 4|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119715|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 2|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 2|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119728|NCT00650260|Primary|Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius|Percent of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C|Upon entry to the post anesthesia care unit|||Percentage of participants|||Number
119716|NCT00650767|Secondary|American College of Rheumatology 20% (ACR20) Response Rate at Week 1|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 1|Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.||percentage of participants||95% Confidence Interval|Number
119717|NCT00650767|Primary|American College of Rheumatology 20% (ACR20) Response Rate at Week 12|"The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.~The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria."|Week 12|Analysis group is comprised of the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.||percentage of participants||95% Confidence Interval|Number
119718|NCT00650585|Primary|Self-reported Lifetime Inhalant Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
119719|NCT00650585|Primary|Self-reported Lifetime Marijuana Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
119720|NCT00650585|Primary|Self-reported Lifetime Cigarette Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
119721|NCT00650585|Primary|Self-reported Lifetime Alcohol Use|Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
119722|NCT00650585|Primary|Self-reported 30-day Inhalant Use|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used inhalants in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
119723|NCT00650585|Primary|Self-reported 30-day Marijuana Use|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used marijuana in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
119724|NCT00650585|Primary|Self-reported 30-day Use of Cigarettes|Students completed an 81-item self-report questionnaire. They were asked on how many days they had smoked cigarettes in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||participants|||Number
119725|NCT00650585|Primary|Self-reported 30-day Use of Alcohol|Students completed an 81-item self-report questionnaire. They were asked on how many days they had used alcohol in the previous 30 days. Response options included “none,” “1 or 2 days in the last month,” “3 to 5 days in the last month,” “6 to 19 days in the last month,” and “20 or more days in the last month.” Response options were dichotomized into none and at least one day.|measured approximately 30 days after intervention completed|Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.||Participants|||Number
119734|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."||participants|||Number
119735|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Responder Population. Various n values are the result of participant attrition."||participants|||Number
119736|NCT00650104|Secondary|Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population)|The Clinical Global Impression (CGI) scale comprises the following three components (CGI-Severity, CGI-Improvement, Index); where only the CGI-S and CGI-I were assessed in this study. CGI-I is a global improvement scale that scores the clinician’s view of the participant’s global functioning prior to and after initiating a study medication from 1 (very much improved) to 7 (very much worse). 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse.|Week 2, Month 12, Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."||participants|||Number
119737|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Maintained Responder Population. Various n values are the result of participant attrition."||points on a scale||Standard Deviation|Mean
119738|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Responder Population. Various n values are the result of participant attrition."||points on a scale||Standard Deviation|Mean
119739|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population)|Two of the six UPDRS sections (Part II, Activities of Daily Living (ADL); Part III, Motor Examination) were assessed in this study. The Motor Exam has 17 items, some of which are assessed in both the left and right extremities. Each item has a choice of 5 responses that are numerically scored 0-4 (0 as the least severe, 4 as the most severe). The final score is a sum of the 17 items, with some sections requiring multiple grades assigned to each extremity, and has a value ranging from 0 (no motor impairment) to 108 (severe motor impairment).|Screening and Month 78|"Intent-to-Treat (ITT) Population. Various n values are the result of participant attrition."||points on a scale||Standard Deviation|Mean
119740|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Maintained Responder : subset of the Responder Population, which was maintained or further decreased for a minimum of 4 weeks whilst the participant received a stable or decreasing dose of study medication. Various “n” values are the result of participant attrition.||points on a scale||Standard Deviation|Mean
119741|NCT00650104|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Months 3, 9, 15, 27, and 78|Responder: a subset of the ITT Population containing those participants who had a score of 1 (very much improved) or 2 (much improved) on the clinical global impression (CGI) scale during the study. CGI-I scores (1 to 7 [very much worse]) the participant’s condition relative to baseline. Various “n” values are the result of participant attrition.||points on a scale||Standard Deviation|Mean
119755|NCT00649792|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)|The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable)|ITT Population. No imputation for missing data||0-10 rating scale||Standard Deviation|Mean
119756|NCT00649792|Secondary|Clinician's Global Impression (CGI)|The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.|Visit 1 and every clinic visit thereafter|ITT Population. No imputation for missing data||1-7 scale rating||Standard Deviation|Mean
119742|NCT00650104|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|Every study visit from baseline to market availability (Month 78)|"All participants who received at least one dose of study medication. The treatment-emergent Study 196 AEs were defined as occurring during initial titration or long-term treatment or follow up."||participants|||Number
119743|NCT00650104|Primary|Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population)|The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.|Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one treatment period evaluation for any parameter were included in the evaluation of the therapeutic benefit. Various “n” values are the result of participant attrition.||points on a scale||Standard Deviation|Mean
119744|NCT00650091|Post-Hoc|Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 15, 30, 45, and 60 weeks (units in liters)|Baseline, 15, 30, 45, 60 week|Analysis population includes participants from the amended study design only.||liters||Standard Deviation|Mean
119745|NCT00650091|Secondary|Number of Participants With Maintained Forced Vital Capacity Response|Maintained forced vital capacity response was a binary variable taking on a value of 1 for participants with higher FVC % predicted at week 60 compared to baseline.|Measured at Week 60|Analysis population includes participants from the amended study design only.||participants|||Number
119746|NCT00650091|Secondary|Respiratory Infections||Measured at Week 60|Analysis population includes participants from the amended study design only.||events|||Number
119747|NCT00650091|Secondary|Acute Exacerbations|"The following 3 criteria will define acute exacerbations in subjects with acute worsening of their respiratory conditions:~1. Clinical (all of the following required): A) Unexplained worsening of dyspnea or cough within 30 days, triggering unscheduled medical care (e.g., emergency room, clinic, study visit, hospitalization). B) No clinical suspicion or overt evidence of cardiac event, pulmonary embolism, or deep venous thrombosis to explain acute worsening of dyspnea. C) No pneumothorax."|Measured at Week 60|Analysis population includes participants from the amended study design only.||events|||Number
119748|NCT00650091|Secondary|Disease Progression|"The time-to-death or a 10% decline in FVC will be defined as the time-to-disease progression.~The 10% decline in FVC from enrollment must be confirmed on 2 consecutive visits no less than 6 weeks apart. For subjects with 2 consecutive visits with a 10% decline in FVC, the time-to-disease progression will be defined as the time interval between enrollment and the initial visit with a 10% FVC decline."|Measured at Week 60|Analysis population includes participants from the amended study design only.||percentage of participants||95% Confidence Interval|Number
119749|NCT00650091|Primary|Overall Change in Forced Vital Capacity|Change from Baseline in Forced Vital Capacity at 60 weeks (units in liters)|Measured as the estimated change from baseline to Week 60|Analysis population includes participants from the amended study design only.||liters||95% Confidence Interval|Mean
119750|NCT00650078|Secondary|Relative Reduction of Morning Stiffness|Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0).|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. Excludes those participants with missing data. Analysis used last observation carried forward imputation.||Relative Change from Baseline (%)||95% Confidence Interval|Median
119751|NCT00650078|Primary|ACR 20 Response Rate at Visit 4|"Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria:~> 20% reduction in the tender joint count (0-28)~> 20% reduction in the swollen joint count (0-28)~> 20% reduction in 3 out of the 5 following additional measures:~Patient’s assessment of pain~Patient’s global assessment of disease activity~Physician’s global assessment of disease activity~Functional Disability Index of the Health Assessment Questionnaire~C-reactive protein or erythrocyte sedimentation rate"|Week 12|Modified Intention to Treat (mITT) efficacy population included all patients who were randomized and received at least 1 dose of study medication. Patients were analyzed according to the treatment to which they were intended to be randomized. All missing values were imputed as non-responders.||participants|||Number
119752|NCT00649961|Secondary|To Define the Pharmacokinetic Profile of Melatonin in Preterm Infants.||6 months||||||
119753|NCT00649961|Primary|To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.||6 months|||pg/ml||Full Range|Median
119754|NCT00649792|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 40 months|Safety Population. No imputation for missing data||participants|||Number
125628|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Other’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
119757|NCT00649792|Secondary|Subject Global Impression (SGI)|For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.|Visit 1 and every clinic visit thereafter (other than the follow-up visit)|ITT Population. No imputation for missing data||1-7 scale rating||Standard Deviation|Mean
119758|NCT00649792|Secondary|Timed 25-Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data||feet/seconds||Standard Deviation|Mean
119759|NCT00649428|Primary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) and 6 months after last treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119760|NCT00649428|Secondary|Evaluator Wrinkle Severity Assessment Responders|A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119761|NCT00649428|Secondary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119762|NCT00649428|Primary|Subject Wrinkle Assessment Responders|A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.|Baseline (prior to first treatment) and 6 months post final treatment|Analysis population was the ITT population, defined as all randomized subjects.||participants|||Number
119763|NCT00649389|Secondary|Change in Seated Systolic Blood Pressure From Baseline to Week 12||Baseline to week 12|||mm Hg||Standard Deviation|Mean
119764|NCT00649389|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure From Baseline to Week 12 or Early Termination||Baseline to 12 weeks or early termination|The ABPM Analysis Set included 440 subjects who provided consent to participate in the ABPM sub-study and who were to provide ABPM measurements prior to and after randomization. Those analyzed is the number who had values at both baseline and 12 weeks or early termination||mm Hg||Standard Deviation|Mean
119765|NCT00649389|Secondary|Percentage of Subjects Who Reached Blood Pressure Goal (<140/90 mmHg; <130/80 mmHg for Subjects With Diabetes, Chronic Renal Disease, or Chronic Cardiovascular Disease)by 12 Weeks||Baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of seated diastolic blood pressure||Percentage of subjects|||Number
119766|NCT00649389|Primary|Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP).||baseline to 12 weeks|The full analysis set consists of subjects who received at least 1 dose of study medication and had a baseline and at least one post-dose assessment of SeDBP||mm Hg||Standard Deviation|Mean
119767|NCT00649220|Secondary|Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.|"VAS is a report device to measure the subject’s burden caused by behavioral symptoms. To measure the burden on the VAS only the first 3 items of the Neuropsychiatric Inventory (NPI) Questionnaire were considered (delusions, hallucinations (visual and auditory), and agitation / aggression). The VAS consists of a 100 mm horizontal line, anchored at the ends with the reference “not at all” and “extremely. The VAS score was determined by measuring in mm from the left hand end of the line to the point, where the investigator had marked the magnitude of a subject’s burden."|Week 8-20 post Baseline|"Intention to treat (ITT).~Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"||Units on a scale [cm]||Standard Deviation|Mean
119768|NCT00649220|Secondary|Change of Nurses’ Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20|"NOSGER is a comprehensive scale, which contains 30 items of behavior, each rated on a 5-point scale according to the frequency of occurrence by direct observation. Item scores are summarized into 6 dimension scores: memory, instrumental activities of daily life, self-care, mood, social behavior, and disturbing behavior. The NOSGER has a scoring range of 30 to 150 with the higher scores indicating worse subject’s status. The items in each group are rated for their frequency ranging from 1 (never) to 5 (always).~A change of <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"||Units on a scale||Standard Deviation|Mean
119769|NCT00649220|Secondary|Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.|"The modified ADCS-ADL19 is comprehensive battery of ADL questions aimed to measure the functional ability of subjects with Dementia of Alzheimer’s type over a broad range of dementia severity. It has a scoring range of 0 to 54 with the lower scores indicating greater functional impairment. Each ADL item was rated from the highest level of independent performance to complete loss.~Change of >0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=18"||Units on a Scale||Standard Deviation|Mean
119784|NCT00648037|Primary|Safety of Rituximab Prophylaxis|The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.|3 months post transplant|Please see Adverse Event section for more details.||participants|||Number
119785|NCT00647998|Secondary|Hemoglobin||Day 7, day 30||||||
119770|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The second part consists of a proxy rating and a self-assessment rating. The scoring range of each rating is 1 to 10. The maximum total score of 10 corresponds to severe depression.~A change <0 reveals an improvement compared to baseline."|Week 4-20 post Baseline|"Intention to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"||units on a scale||Standard Deviation|Mean
119771|NCT00649220|Secondary|"Change of Test for the Early Detection of Dementia With Discrimination From Depression [TE4D] Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia"|"TE4D is a psychometric, physician-administered test that is used for both screening subjects with early dementia and monitoring the clinical progress of the disease. The first part consists of 9 items, which assess different symptoms associated with dementia such as memory, time-orientation, etc. The scoring range is 0 to 50 points. A score of 35 or lower is an indication of dementia.~A change >0 represents an improvement."|Week 4-20 post baseline|"Intent to treat (ITT).~Week 4: n=18; Week 8: n=17; Week 12: n=16; Week 16: n=16; Week 20: n=17"||units on a scale||Standard Deviation|Mean
119772|NCT00649220|Secondary|Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.|MMSE is a brief, physician–administered scale, designed for measuring the cognitive functions, such as: orientation, memory, attention, naming, and comprehension. The scoring range of MMSE is 0 to 30 points. A score of 23 or lower is indicative of cognitive impairment. Change of >0 reveals an improvement compared to baseline.|Week 20 post baseline|Intention to treat (ITT)||units on a scale||Standard Deviation|Mean
119773|NCT00649220|Secondary|Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.|See #1 and #8. Change of <0 reveals a reduction of AP compared to baseline.|Week 8-20 post Baseline|"Intention to treat (ITT).~Week 8: n=16; Week 12: n=14; Week 16: n=13; Week 20: n=15"||Percent of daily dose [DDD]||Standard Deviation|Mean
119774|NCT00649220|Primary|Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.|VAS: see #8. Mean “percent of the total Defined Daily Dose (DDD)”, averaged over one week, was calculated. Total DDD was calculated as sum of DDD for each AP drug. DDD is the assumed average maintenance dose per day defined by WHO. The reduction of AP Δ [percent] was calculated as a difference between the mean total DDD recorded at baseline and the mean total DDD recorded at the respective week. Measurements from those post-baseline visits were taken into account only when the value of the VAS was not substantially worse compared to baseline.|Week 8-20 post baseline|Intention to treat (ITT)||Percent of daily dose [DDD]||Standard Deviation|Mean
119775|NCT00648908|Secondary|Expanded Disability Status Scale (EDSS)|"Each patient, based on their baseline neurological exam, are scored according to the EDSS~The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable."|Screening visit, visit 6 and every 24 months thereafter|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
119776|NCT00648908|Secondary|Clinician Global Impression of Change (CGIC)|"Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS.~The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse."|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
119777|NCT00648908|Secondary|Subject Global Impression (SGI)|"Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS).~For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted."|visit 1 and every clinic visit|ITT Population. No imputation for missing data||units on a scale||Standard Deviation|Mean
119778|NCT00648908|Secondary|Timed 25 Foot Walk (T25FW)||Week 2, 14, 26, continuing every 26 weeks until the Final Visit|ITT Population. No imputation for missing data||feet/second||Standard Deviation|Mean
119779|NCT00648908|Primary|Summary of Treatment Emergent Adverse Events (TEAE).|All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.|up to 5 years|Safety Population. No imputation for missing data||Participants|||Number
119780|NCT00648895|Primary|Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).|Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).|Before treatment and after 10 weeks|Due to the small sample size, no efficacy conclusion could be made. 0 measured value primary outcome =Not applicable.||Percentage||Standard Deviation|Mean
119781|NCT00648167|Primary|The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)||28 days|||mg/dL||Standard Deviation|Mean
119782|NCT00648115|Secondary|Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)|overall economic impact, in dollars, will be evaluated by the following formula: income - healthcare cost - cost of incarceration|12 months|||dollars||Standard Deviation|Mean
119783|NCT00648115|Primary|Time Till Employment in Days|Number of days until first day of competitive employment|12 months|||number of days to first employment||95% Confidence Interval|Mean
119786|NCT00647998|Secondary|CSF Markers of Ischemia||24 hours||||||
119787|NCT00647998|Primary|Death or Neurologic Disability, Defined as an NIHSS>4 or ASIA<25||Discharge|||Participants|||Count of Participants
119788|NCT00647699|Primary|Mean Change From Baseline in Maximum Keratometry (Kmax)|The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.|baseline,12 months|The ITT (intent to treat) population consisted of all treated subjects, analyzed according to the treatment actually received. For the sham study eyes that received CXL treatment after baseline, the last Kmax measurement recorded prior to receiving CXL treatment was used in the analysis for later time points.||diopters||Standard Deviation|Mean
119789|NCT00647556|Secondary|Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24|Number of participants in each category of the Investigator Evaluation of Global Response (Improvement) at week 12 and week 24. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (~90%) Response, 2 = Marked (~75%) Response, 3 = Moderate (~50%) Response, 4 = Slight (~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
119790|NCT00647556|Secondary|Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24|Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (~90%) Improvement, 2 = Marked (~75%) Improvement, 3 = Moderate (~50%) Improvement, 4 = Slight (~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst.|week 12 and week 24|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)||participants|||Number
119791|NCT00647556|Secondary|Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.|Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 12|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
119792|NCT00647556|Secondary|Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24|Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|baseline, week 12 and week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
119793|NCT00647556|Primary|Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24|Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.|baseline to week 24|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)||participants|||Number
119794|NCT00647400|Secondary|Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.||Participants|||Number
119795|NCT00647400|Secondary|Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.||Participants|||Number
119796|NCT00647400|Primary|Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)|PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).|Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed.||Participants|||Number
119797|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.||units on a score||Standard Error|Least Squares Mean
119827|NCT00646776|Primary|Minimum Plasma Concentration (Cmin) of RIB|Cmin was derived from plasma concentration versus time for RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
119798|NCT00647270|Secondary|Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.||units on a score||Standard Error|Least Squares Mean
119799|NCT00647270|Secondary|Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (LOCF).||units on a score||Standard Deviation|Mean
119800|NCT00647270|Secondary|Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)|The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline and Week 12|Full Analysis Set (FAS)-a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses (observed).||units on a score||Standard Deviation|Mean
119801|NCT00647270|Primary|The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)|Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit|Week 12|Full Analysis Set (FAS) - a subset of the intent to treat population used in all efficacy analyses excluding subjects from an Abbott identified Investigator who was non-compliant with the protocol requirements. The FAS of subjects who received at least 1 dose of study drug during Period 2 of the study was used for Period 2 efficacy analyses.||participants|||Number
119802|NCT00646958|Secondary|Number of Patients With Per-Patient Microbiologic Response of Eradicated|The microbiological response at the patient level was considered Eradicated (documented or presumed)if no pathogens were present in repeat cultures taken from the original site of infection or a clinical response of cure precluded the ability to obtain a culturable specimen.|Test of Cure (TOC), day 10-20|Microbiologically Evaluable patients were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before TOC, presented for a TOC evaluation in the appropriate window, and who had a baseline pathogen that was susceptible to study drug.||Participants|||Number
119803|NCT00646958|Primary|Number of Participants With a Clinical Response of Cure|To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.|Test of Cure (TOC), day 10-20|Clinically Evaluable participants were those that met the entry criteria, received a certain amount of drug, did not receive any additional antibiotics before Test of Cure (TOC), and who presented for a TOC evaluation in the appropriate window.||Participants|||Number
119804|NCT00646776|Secondary|Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic), and heart rate. Physical examination included a neurological examination (if ocular signs or symptoms occurred, a reflex to slit lamp exam was performed by an ophthalmologist). The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Vital signs:screening, prior to dosing on Day 1, Day 7, study discharge. Physical examination:screening, Day -1, Day 7, study discharge|All treated participants.||Participants|||Number
119805|NCT00646776|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities were defined as findings that are clinically meaningful as judged by the investigator. A 12-lead ECG was recorded at least 5 minutes after the participant had been lying down and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|Pre-dose on Day -1 and study discharge.|All participants who received the study drug on Day 1 were included in the analysis.||Participants|||Number
120380|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 75% of Expiratory Vital Capacity (MEF75)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
119806|NCT00646776|Secondary|Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs. Protein, glucose and blood: >=2+ (or, if pre-treatment value >=1+, then >= 2 x pre-treatment value).|Pre-dose on Day -1, Day 7 and discharge.|"All participants who received the study drug on Day 1 were included in the analysis. If a value had not evaluable in the dataset, then these participants were not counted (for all parameters: protein, glucose and blood)."||Participants|||Number
119807|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 x LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8 x pre-Rx or >ULN. If pre-Rx >ULN, then >2.0 x pre-Rx or <LLN. Albumin: <0.9 x LLN (if pre-Rx <LLN, then <0.9 x pre-Rx). Creatine kinase: >1.5 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx). Uric acid: >1.2 x ULN (if pre-Rx >ULN, then >1.25 x pre-Rx). LDH: >1.25 x ULN (if pre-Rx >ULN, then >1.5 x pre-Rx).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(albumin, creatine kinase, uric acid and LDH)."||Participants|||Number
119808|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Chloride (serum), calcium (total), protein (total):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN). Bicarbonate:<0.8xLLN or >1.2xULN (if pre-Rx value <LLN, then <0.8xpre-Rx value or >ULN. If pre-Rx >ULN, then >1.2xpre-Rx value or <ULN). Phosphorous (inorganic):<0.85xLLN or >1.25xULN (if pre-Rx <ULN, then <0.85xpre-Rx or <ULN. If pre-Rx >ULN, then >1.25x re-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|All treated participants.||Participants|||Number
119809|NCT00646776|Secondary|Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum)|MAs=laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, AST, ALT:>1.25xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Bilirubin (total), bilirubin (direct), BUN:>1.1xULN (if pre-Rx >ULN, then >1.25xpre-Rx). Creatinine:>1.33xpre-Rx. Sodium (serum):<0.95xLLN or >1.05xULN (if pre-Rx <LLN, then <0.95xpre-Rx or >ULN. If pre-Rx >ULN, then >1.05xpre-Rx or <LLN). Potassium (serum):<0.9xLLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (ALP, AST, ALT, bilirubin [total], bilirubin [direct], BUN and creatinine)."||Participants|||Number
119810|NCT00646776|Primary|Total Area Under the Plasma Concentration-time Curve (AUCtot)|AUCtot represents the total free RIB plus 25-O-Desacetyl-RIB output. It is calculated as: AUCtot (micromolar[µM]*h) = AUC24avg(RIB)(ng*h/mL)/847.016 (g/mole) + AUC24avg(25-O-Desacetyl-RIB)(ng*h/mL)/804.979(g/mole). The 300 mg RIB arm represents an extrapolation from the 150 mg RIB group.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|"All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis. The RIB 300 mg arm represents an extrapolation of the RIB 150 mg arm and as such, does not have a value for Number of Participants Analyzed. AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD."||µM*h||Full Range|Geometric Mean
119811|NCT00646776|Primary|Cmin of 25-O-Desacetyl-RIB|Cmin was derived from plasma concentration versus time for 25-O-Desacetyl-RIB.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
119812|NCT00646776|Primary|Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB)|Cmax was derived from the plasma concentration versus time for 25-O-Desacetyl-RIB (a metabolite of RIB) and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
119813|NCT00646776|Primary|AUC24avg for 25-O-Desacetyl-RIB|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150 mg QD; AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng*h/mL||Full Range|Geometric Mean
119828|NCT00646776|Primary|Maximum Plasma Concentration (Cmax) of RIB|Cmax was derived from plasma concentration versus time for RIB and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
120381|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted RV||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
119814|NCT00646776|Secondary|Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils+bands (absolute): <=1.50 x 10^3 cells/microliter (uL). Lymphocytes (absolute): <0.75 x 10^3 cells/uL or >7.50 x 10^3 cells/uL. Monocytes (absolute): >2.00 x 10^3 cells/uL. Basophils (absolute): >0.40 x 10^3 cells/uL. Eosinophils (absolute): >0.75 x 10^3 cells/uL.|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted(neutrophils + bands [absolute], monocytes [absolute], basophils [absolute] and eosinophils [absolute])."||Participants|||Number
119815|NCT00646776|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin/hematocrit: <0.85 x pre-treatment (pre-Rx) value. Platelet count: <0.85 x lower limit of normal (LLN) (or, if pre-Rx value <LLN, then <0.85 x pre-Rx value) or >1.5 x upper limit of normal (ULN). Leukocytes: <0.9 x LLN or >1.2 x ULN (or, if pre-Rx value <LLN, then <0.85 x pre-Rx or >ULN. If pre-Rx value >ULN, then >1.15 x pre-Rx or <LLN).|Pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14, 20 and 26 for RIB 150 mg QD; and pre-dose on Day -1 and post-dose on Days 3, 7, 11, 14 and 18 for ATV/RTV 300/100 mg QD + RIB 150 mg twice weekly.|"All treated participants. If a value had not evaluable in the dataset, then these participants were not counted (hemoglobin and hematocrit)."||Participants|||Number
119816|NCT00646776|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation.|AEs were defined as new, untoward medical occurrences/worsening of pre-existing medical condition, whether drug-related or not. SAEs were defined as any AE that: resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose. Discontinuation from the study was due either to an AE or was conducted at the investigator's discretion.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.||Participants|||Number
119817|NCT00646776|Secondary|T-half of RTV|T-half was obtained directly from the concentration-time data.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||Hour||Standard Deviation|Mean
119818|NCT00646776|Secondary|Tmax of RTV|Tmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||Hour||Full Range|Median
119819|NCT00646776|Secondary|AUC(TAU) for RTV|AUC(TAU) was derived from the plasma concentration versus time for RTV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||ng*h/mL||Full Range|Geometric Mean
119820|NCT00646776|Secondary|Cmin of RTV|Cmin was derived from the plasma concentration versus time for RTV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
119821|NCT00646776|Secondary|Cmax of RTV|Cmax was derived from the plasma concentration versus time for RTV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RTV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
119822|NCT00646776|Secondary|Terminal Elimination Half-life (T-half) of ATV|T-half was obtained directly from the concentration-time data. T-half following doses administered for treatment ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||Hour||Standard Deviation|Mean
119823|NCT00646776|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV|Tmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||Hour||Full Range|Median
119824|NCT00646776|Secondary|AUC(TAU) for ATV|AUC(TAU) was derived from the plasma concentration versus time for ATV, and was calculated by linear and log-linear trapezoidal summations using a mixed log-linear algorithm.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||ng*h/mL||Full Range|Geometric Mean
119825|NCT00646776|Secondary|Cmin of ATV|Cmin was derived from the plasma concentration versus time for ATV.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
119826|NCT00646776|Secondary|Cmax of ATV|Cmax was derived from the plasma concentration versus time for ATV and was recorded directly from experimental observations for each treatment period.|Pre-dose (0h) on Days 4, 8, 11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of ATV as specified per protocol, and were evaluable for analysis.||ng/mL||Full Range|Geometric Mean
120382|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Residual Volume (RV)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
119829|NCT00646776|Primary|Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)|AUC24avg is AUC(0-24 hour) following dosing on Day 10 for RIB 150mg once daily (QD); AUC24avg is the area under the plasma concentration-time curve in 1 dosing interval (AUC[TAU]) divided by the number of days over the sampling duration for ATV/RTV 300/100 mg QD+RIB 150 mg twice weekly, i.e. AUC(TAU)/7.|Pre-dose (0 hours [h]) on Days 6, 8, 10, and 11, and post-dose (1h,2h,3h,4h,6h,8h,12h) on Day 10 for RIB 150 mg QD; and pre-dose (0h) on Days 4, 8,11 to 18 and post-dose (1h,2h,3h,4h,6h,8h,12h) on Days 11 and 15 for ATV/RTV + RIB.|All treated participants who received all doses of RIB as specified per protocol, and were evaluable for analysis.||nanograms*hour /milliliters (ng*h/mL)||Full Range|Geometric Mean
119830|NCT00646763|Primary|Number of Participants for Whom Target Number of CD34+ Cells Were Collected.|Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment|7 days|||participants|||Number
119831|NCT00646763|Secondary|Total Number of Days of Apheresis|the number of days of apheresis required to collect target numbers of CD34+ cells.|7 days|||days||Standard Deviation|Mean
119832|NCT00646763|Primary|The Total Number of CD34+ Cells Collected.||4 days|Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin’s disease, non-Hodgkin’s lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study.||cells per Kg||Standard Deviation|Mean
119833|NCT00646646|Primary|Dynamic Eye Movement Measures|Change in Eye Movements Parameters|baseline to Sedation State (approx. 1 hr)|||degrees/second||95% Confidence Interval|Mean
119834|NCT00646581|Primary|Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). False alarm rate refers to the proportion of overall attempts that were characterized as incorrect responses (responses to two non-identical targets). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||Proportion of overall attempts||Standard Deviation|Mean
119835|NCT00646581|Primary|Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in detail in a previous outcome measure (CPT d score). Reaction time of hits refers to the average time each participant took to correctly respond to a stimuli in milliseconds. Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||Milliseconds||Standard Deviation|Mean
119836|NCT00646581|Primary|Improvement in Cognitive Function- CPT Hits Rate (Proportion)|"Subjects performed a computer-based test designed to measure sustained attention before and after intranasal treatment. The task is described in the previous outcome measure (CPT d score). Hits rate refers to each participant's ability to correctly respond to two consecutive target presentations (i.e. correct responses). Hits rate was measured as a proportion of overall attempts (0= no hits, 1.0= 100% accuracy on hits). Values below represent posttreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized either to the experimental or placebo group.||Proportion of overall attempts||Standard Deviation|Mean
119837|NCT00646581|Primary|CPT d Score|"Subjects performed a computer-based test designed to measure sustained attention (attention to a specific stimuli over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance."|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||units on a scale||Standard Deviation|Mean
119838|NCT00646581|Primary|Improvement in Cognitive Function- HVLT-Delayed Recall (Number)|Subjects performed the HVLT word recall task after a 20-minute delay before and after intranasal treatment. In the HVLT delayed recall task, participants were asked to recall the same list of 12 words dictated in the immediate recall task 20 minutes after the completion of the immediate recall task. Words successfully recalled after the 20-minute delay were measured. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed in this study. Subjects were randomized to either the experimental or placebo group.||Words successfully recalled||Standard Deviation|Mean
119839|NCT00646581|Primary|Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)|Subjects performed the HVLT Immediate Recall Task. For this task, participants were read aloud a list of 12 words from three taxonomic categories. Participants were read the list three separate times, and after each reading were immediately asked to recall as many words from the list as they could. The number of words recalled successfully was measured before and after intranasal treatment. Values below represent posttreatment performance minus pretreatment performance.|pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration|30 subjects were analyzed. Subjects were randomized to either the experimental or placebo group.||Words successfully recalled||Standard Deviation|Mean
119840|NCT00646399|Primary|The Number of Participants With Staphylococcal Sepsis From Study Days 0 to 35.|Safety and efficacy|35 days|1579 very low birth weight subjects were included in the ITT.||Participants|||Number
119841|NCT00646282|Primary|Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels|Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months|18 months|Data not analyzed due to study termination|||||
119842|NCT00646048|Secondary|Number of Participants Who Achieve Technical Success of the Stent Graft System.|Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.|Post procedure|||Participants|||Number
119843|NCT00646048|Primary|Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).|A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.|1 month|||Participants|||Number
119844|NCT00646048|Primary|Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.|Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.|1 month|||Participants|||Number
119845|NCT00645970|Primary|Numeric Rating Scales of Pain Over Past Week (11 Point Likert Scale)|Numeric Pain Rating Scale is a self-report measure of “usual” (average) pain intensity over the last week; response options range from “no pain” (0) to “worst pain imaginable” (10). A score >3 indicates moderate-to-severe pain.|Baseline, 6 months, 1 year|Numeric Pain Rating Scale data are missing for 21 participants (PSC n=1; Registry n=20)||units on a scale||Standard Deviation|Mean
119846|NCT00645944|Primary|Change in Insomnia Severity Index From Baseline.|The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach’s alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.|8 Weeks|Of 39 eligible participants, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication. 36 participants were included in the modified ITT analysis||units on a scale||95% Confidence Interval|Least Squares Mean
119847|NCT00645853|Secondary|AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment||154-711 days on treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis||nmol/L||Full Range|Median
119848|NCT00645853|Secondary|AZD0837: Plasma Concentration of AZD0837 at End of Treatment||End of treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis||nmol/L||Full Range|Median
119849|NCT00645853|Secondary|Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment||Baseline and End of Treatment|Only patients who switched to one dose, 300 mg od, are included in the AZD0837 analysis||sec||Full Range|Median
119850|NCT00645853|Secondary|Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment|Median Full range, Seconds|Baseline and End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis||sec||Full Range|Median
119851|NCT00645853|Secondary|D-dimer:Median and Quartile Range at End of Treatment|Median (Lower Quartile-Upper Quartile ), ng/mL|End of treatment|Only patients who switched to one common dose, 300 mg od, are included in the AZD0837 analysis||ng/mL||Inter-Quartile Range|Median
119852|NCT00645853|Secondary|Creatinine: Absolute Change From Baseline, at End of Treatment||Baseline and End of treatment|||µmol/L||Full Range|Mean
119853|NCT00645853|Secondary|Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline||From baseline to Follow up|||Participants|||Number
119854|NCT00645853|Secondary|Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline|ULN=Upper limit of Normal|From baseline to Follow up|||Participants|||Number
119855|NCT00645853|Primary|Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period|Participants|154-711 days on treatment|||Participants|||Number
119856|NCT00645827|Secondary|Hypoglycemia (Serum Blood Glucose < 70 mg/dL)||Within 24 hours after cessation of IV insulin||||||
119857|NCT00645827|Primary|Percentage of Blood Glucose Values Within 80-140 mg/dL|Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL|Within 24 hours after cessation of IV insulin|||percentage of blood glucose values|||Number
119858|NCT00645788|Secondary|Number of Participants With the Occurrence of Drug Induced Bronchospasms|"Bronchospasm reported as adverse event: Bronchospasm defined as >=15% drop in FEV1, and may also include allergic and excercise-induced bronchospasm. Drug-induced bronchospasm: Treatment-emergent bronchospasm was defined as >=15% drop in FEV1 in the ITT/safety population. Note: One of the bronchospasm events was considered a serious adverse event, and it was not included under other adverse events. A sum of bronchospasm events was 1+6=7."|Up to visit 9 (Day 56-60)|Intent to treat||participants|||Number
119859|NCT00645788|Secondary|Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment|Sputum concentrations measured using validated HPLC-MS/MS methods in selected patients to contribute kinetic information for an inter-study population sputum kinetic evaluation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.|||||
119860|NCT00645788|Secondary|Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment|Plasma concentrations measured using validated high pressure liquid chromatography-mass specroscopy/mass spectroscopy (HPLC-MS/MS) methods in selected patients at predefined time windows to contribute pharmacokinetic (PK) information for an inter-study population PK evaluation. Sampling window for Plasma: Predose (trough level), <15 min, 2.0 - 2.5 hour, and 4.0 - 7.0 hours after the end of inhalation. Number of samples vary at different time points.|Up to visit 7 (Day 28-30)|Analysis was not performed due to insufficient data.|||||
119861|NCT00645788|Secondary|Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale|The CF quality of life questionnaire revised (CFQ-R), a validated disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). It is self-administered and consists of 44 items, divided into 12 generic and disease-specific scales. The scale includes physical functioning, role, vitality, emotional functioning, social functioning, body image, eating disturbances, treatment burden, health perceptions, weight, respiratory symptoms, and digestive symptoms. Scale range: 0 to 100 (maximum). Better outcome with higher values.|Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60)|Intent to treat||scores on a scale||Standard Deviation|Mean
119862|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates|Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The “susceptible” bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.|Baseline and up to visit 9 (day 56-60)|Intent to treat||Participants|||Number
119863|NCT00645788|Secondary|Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates|Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The “susceptible” bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy.|Baseline and up to visit 9 (day 56-60)|Intent to treat||Participants|||Number
119864|NCT00645788|Secondary|Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9|FEF 25-75% (also known as the maximum midexpiratory flow [MMEF]): The mean forced expiration flow over the middle half of the forced vital capacity (FVC). It was taken from the blow with the largest sum of FEV1 and FVC. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||Percent of predicted FEF 25-75%||Standard Deviation|Mean
119865|NCT00645788|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9|FVC: The maximal volume of air exhaled with maximally forced effort from a maximal inspiration, ie, vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS (body temperature and ambient pressure saturated with water vapor). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||Percent of predicted FVC||Standard Deviation|Mean
119866|NCT00645788|Secondary|Time to First Pulmonary Exacerbation Requiring Intervention|Pulmonary exacerbations: Assessment of pulmonary exacerbation was conducted by the treating physician as part of the physical examination. Pulmonary exacerbation was defined by chest examination findings and any or all of the following symptoms: decreased exercise tolerance, increased cough, increased sputum/cough congestion, school or work absenteeism, increased adventitial sounds on the lung examination, and decreased appetite.|Up to visit 9 (Day 56-60)|Intent to treat||Days||Inter-Quartile Range|Median
119867|NCT00645788|Secondary|Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9|Density of P. aeruginosa in the sputum is expressed as log10 of colony forming units (CFU)/gram (g). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||log10(cfu/g)||Standard Deviation|Mean
119868|NCT00645788|Secondary|Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60).|Intent to treat||Percent of predicted FEV1||Standard Deviation|Mean
119869|NCT00645788|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28‑30|FEV1: The maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used.|Baseline and End of treatment (Day 28-30)|Intent to treat||Percent of predicted FEV1||Standard Deviation|Mean
119870|NCT00645762|Primary|Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement|"Symptomatic change in SNOT 20 scores on a 5-point Likert scale where 0 = no problem to 5 = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful."|Post-treatment through 12 months|Score reduction in SNOT 20 Scale Scores. Baseline through 12 months post-procedure.||Scores on a scale|||Number
119871|NCT00645762|Primary|Patency of the Treated Area as Verified by CT Scan|Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians.|Post-treatment at 3 months|Analysis of ostia patency done per protocol||Ostia|Participants||Number
119872|NCT00645762|Primary|Incidences of Device-related or Procedure-related Complications||Through 12 months post-procedure|Patients completing 12 month follow-up||participants|||Number
119873|NCT00645671|Primary|Grade 0 for Pain|Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe|Postoperative Day 8 (Visit 5)|Intent to treat population||participants|||Number
119874|NCT00645671|Secondary|Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Baseline and each follow-up visit through day18 (Visit 7)|Intent to treat population||Composit scores||Standard Deviation|Mean
119875|NCT00645671|Secondary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|At each follow-up visit through day18 (Visit 7)|Intent to treat population||participants|||Number
119876|NCT00645671|Primary|Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.|A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.|Postoperative Day 8 (Visit 5)|Intent to treat population||participants|||Number
119877|NCT00645593|Secondary|Median Overall Survival in Months|Median overall survival in months is provided. One participant who progressed from chemotherapy in arm 1 received cyclophosphamide and achieved long-term disease control therefore there is no upper limit for the 95% confidence interval.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.||Months||95% Confidence Interval|Median
119878|NCT00645593|Secondary|Median Progression-free Survival Time in Months|Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.||months||95% Confidence Interval|Median
119879|NCT00645593|Secondary|The Number of Grade 3 to 5 Adverse Events Experienced by Arm 1 and Arm 2|"One of the secondary outcomes was to assess the safety and tolerability of treatment for both arms.~The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were utilized for adverse event reporting."|3 years|Although 60 participants were enrolled and randomized to arm 2, 1 participant withdrew consent prior to treatment and was therefore excluded from toxicity analysis.||adverse events|||Number
119880|NCT00645593|Primary|Percentage of Participants That Respond to Treatment in Arm 1 and Arm 2|"The primary objective is to compare the overall response rate of participants with locally advanced or metastatic urothelial carcinoma treated with gemcitabine and cisplatin with or without cetuximab.~Overall response rate is defined as the percentage of participants that experience Complete Response (CR) (Disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest diameter of target lesions)."|3 years|29 patients were enrolled and randomized to arm 1 and 60 patients were enrolled and randomized to arm 2. 1 patient from arm 1 was found to be ineligible and 3 patients from arm 2 withdrew consent (1 prior to treatment and 2 prior to 4 weeks of treatment). Only 28 patients from arm 1 and 57 patients from arm 2 were analyzed.||percentage of participants||95% Confidence Interval|Number
119881|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here."|Visit 2 (week 2)|||units on a scale||Standard Deviation|Mean
119882|NCT00645528|Primary|Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here."|Visit 1 (week 0)|||units on a scale||Standard Deviation|Mean
119883|NCT00645528|Secondary|Number of Patients Experiencing a Severe Hypoglycemic Event|Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia|2 weeks|||participants|||Number
119884|NCT00645528|Secondary|Number of Subjects Experiencing Hypoglycemic Symptoms|Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits|2 weeks|As below, 15 subjects reported subjective symptoms of hypoglycemia in the two weeks between study visits; 10 of these subjects had at least one recorded blood glucose value less than 70 mg/dl; Eight of these 10 subjects had started insulin.||participants|||Number
119885|NCT00645528|Secondary|Percent of Patients Who Begin Insulin||2 weeks|||percentage of participants|||Number
125629|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Metabolic/Endocrine’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
119886|NCT00645528|Primary|"Change in Barriers to Insulin Treatment (BIT) Score From Before to After the Classes"|"The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale (Expectations regarding positive insulin-related outcomes) where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test."|2 weeks|32 subjects completed the study||units on a scale||Standard Deviation|Mean
119887|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.|To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.|up to 7 days after each vaccination|The analysis was performed on the safety dataset set.||Subjects|||Number
119888|NCT00645411|Secondary|Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .|up to 7 days after vaccination|The analysis was performed on the safety dataset||Subjects|||Number
119889|NCT00645411|Secondary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.~According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
119890|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.~The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
119891|NCT00645411|Secondary|Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children|"To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.~The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5"|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
119892|NCT00645411|Secondary|Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children|To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.|Day 29 and Day 50 post vaccination|The analysis was performed on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
119893|NCT00645411|Secondary|Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.~According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
119894|NCT00645411|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.~This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Percentages of subjects||95% Confidence Interval|Number
119895|NCT00645411|Secondary|Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.|"Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Ratio||95% Confidence Interval|Geometric Mean
121777|NCT00626821|Primary|Quality of Life (Scale 0(Worst)-100(Best))|The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.|6-8 weeks|ITT||units on a scale||Standard Deviation|Mean
119896|NCT00645411|Secondary|Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents|"To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.~GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 29 post vaccination|The analysis was performed on the per-protocol dataset.||Titers||95% Confidence Interval|Geometric Mean
119897|NCT00645411|Primary|Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.~Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset||Percentages of subjects||95% Confidence Interval|Number
119898|NCT00645411|Primary|Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children|"To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.~GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay."|Day 50 post vaccination|The analysis was performed on the per-protocol dataset||Titers||95% Confidence Interval|Geometric Mean
119899|NCT00645359|Primary|To Correlate the Changes on MR Images With the Tumor Response After Completion of Chemotherapy and Duration of Response.|Tumor response will be determined by the clinical evaluation, tumor dimensions, and metabolic response as assessed by 18-Fluoro-deoxy.|2 years||||||
119900|NCT00645359|Primary|Mean Difference in Apparent Diffusion Coefficient|To assess whether changes in the apparent diffusion coefficient (ADC) during the early phase of chemotherapy are detectable in lymphoma, the ADC value will be calculated at the voxel level, on baseline and Day 8, and the mean difference will be calculated.|Baseline and Day 8|No patients were analyzed due to insufficient resources, secondary to shifting research priorities.|||||
119901|NCT00645333|Primary|Maximum Tolerated Dose (MTD)|The Maximum Tolerated Dose (MTD) for MK-0752 will be determined. Dose levels were: Level 1: 300 mg MK-0752 by mouth days 1-3; Level 2: 450 mg MK-0752 by mouth days 1-3; Level 3: 600 mg MK-0752 by mouth days 1-3; Level 4: 800 mg MK-0752 by mouth days 1-3.|Up to 3 years|||mg|||Number
119902|NCT00645333|Primary|Dose Limiting Toxicity (DLT)|"The number of DLTs experienced by participants within the first 21 days.~DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows:~Non-hematologic toxicity Grade ≥3 by the NCI CTCAE version 3.0.~ANC<1000 for more than 7 days despite use of pegfilgrastim.~Platelet count <25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time."|first 21 days|||Dose Limiting Toxicities|||Number
119903|NCT00645164|Primary|Frequency Distribution of Skin Irritation Scores|Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.|48-hours post irradiation|Analysis was based on number of subjects who completed the study.||Scores on a scale|||Number
119904|NCT00645099|Secondary|Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)|PANSS is an investigator-rated 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provided a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline to End Point (up to 6 months)|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||points on a scale||Standard Deviation|Mean
119905|NCT00645099|Secondary|Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up|"Metabolic syndrome is defined according the Third Report of the National Cholesterol Education Program Expert Panel on~Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP/ATPIII) of which 3 out of 5 criteria must be met:~waist circumference men > 102 cm; waist circumference women > 88 cm~TG ≥ 150 mg/dL~HDL cholesterol men <40 mg/dL; HDL cholesterol women <50 mg/dL~Blood pressure systolic ≥ 130 mmHg; Blood pressure diastolic ≥ 85 mmHg~Fasting glucose ≥ 110 mg /dL"|6 months|The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. In this case, the total number of patients in the analysis set depends on the number of patients without metabolic syndrome at baseline.||Participants|||Number
119906|NCT00645099|Secondary|Change From Baseline at End Point in Waist Circumference|Patients had to be instructed to stand erect with abdomen relaxed, arms at sides, feet together, and weight divided equally over both legs. The tape measure was placed around the bare abdomen midway between the palpated iliac crest and the palpated lowest rib margin in the left and right mid-axillary lines. A nonstretchable tape was evenly placed around the natural waist covering the left and right natural-waist marks. The measurement scale had to face outward, and there could not be any twists in the tape. The tape had to be just touching the skin but not compressing the soft tissue.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||cm||Standard Deviation|Mean
119907|NCT00645099|Secondary|Change From Baseline at End Point in Body Mass Index (BMI)|BMI is calculated by dividing the body weight (in kg) by the square of height (in meters).|Baseline to End Point (up to 6 months)|||kg/m²||Standard Deviation|Mean
120133|NCT00642616|Secondary|Number of Participants With Asthma Exacerbation by Treatment Arm|Number of participants who experienced worsening of asthma symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying Asthma||participants|||Number
119908|NCT00645099|Secondary|Change From Baseline at End Point in Body Weight|Patients were weighed lightly clothed. The same amount of clothing had to be worn each time.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||kg||Standard Deviation|Mean
119909|NCT00645099|Secondary|Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin|As another measure of beta-cell function, the relationship between plasma insulin and glucose concentrations during the OGTT was calculated using a simplified version of the method described by Mari et al. (Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab. 2005; 90:4888-4894.).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||pM/mM||Standard Deviation|Mean
119910|NCT00645099|Secondary|Change From Baseline at End Point of the Insulinogenic Index|The insulinogenic index, defined as (insulin at 30 min - insulin at 0)/(glucose at 30 min [G(30)] - glucose at 0 [G(0)]) was used as a measure of early insulin secretion in response to the OGTT. Because the index is undefined when G(30)-G(0)=0, and poorly defined when G(30)-G(0)<0, the index was only calculated when G(30)>G(0).|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||pM/mM||Standard Deviation|Mean
119911|NCT00645099|Secondary|Number of Patients With Impaired Fasting Glucose|Post-baseline glucose level under fasted conditions ≥100 mg/dL but <126 mg/dL.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||Participants|||Number
119912|NCT00645099|Secondary|Number of Patients With Onset of Impaired Glucose Tolerance|Glucose ≥140 mg/dL, <200 mg/dL after a 75g OGTT.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||Participants|||Number
119913|NCT00645099|Secondary|Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up|Fasting plasma glucose ≥126 mg/dL or 2-hour post-load plasma glucose ≥200 mg/dL during an oral glucose tolerance test (OGTT) or initiated use of glucose-lowering agents during the course of the study.|6 months|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||Participants|||Number
119914|NCT00645099|Secondary|Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is used to assess insulin resistance (IR). HOMA-IR is a dimensionless measure of insulin resistance (higher values present more insulin resistance. HOMA-IR are normalized so that lean, healthy individuals will have values of HOMA-IR close to 1.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||dimensionless||Standard Deviation|Mean
119915|NCT00645099|Secondary|Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)|"HOMA-%B is used to assess beta-cell function. HOMA-%B is a dimensionless measure of beta-cell function (higher values present increased insulin secretion for a given glucose level).~HOMA-%B is normalized so that lean, healthy individuals will have values of HOMA-%B close to 100%."|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post baseline data for the particular secondary efficacy parameter under discussion.||dimensionless||Standard Deviation|Mean
119916|NCT00645099|Secondary|Change From Baseline to End Point in Fasting Glucose||Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||mmol/L||Standard Deviation|Mean
119917|NCT00645099|Secondary|Change From Baseline to End Point in Converted Insulin|The insulin level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||pmol/L||Standard Deviation|Mean
119918|NCT00645099|Secondary|Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)|The level of low density lipoprotein cholesterol was calculated using the Friedwald QT formula.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||mmol/L||Standard Deviation|Mean
120134|NCT00642616|Primary|Change in Post-bronchodilator FEV1 From Baseline to Week 52|Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.|52 Weeks|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns.|||||
119919|NCT00645099|Secondary|Change From Baseline to End Point in Total Cholesterol|The total cholesterol level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|Safety data were analyzed using the Intent-to-Treat (ITT) analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data.||mmol/L||Standard Deviation|Mean
119920|NCT00645099|Secondary|Change From Baseline to End Point in High Density Lipoprotein|The HDL level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||mmol/L||Standard Deviation|Mean
119921|NCT00645099|Secondary|Change From Baseline to End Point in Triglycerides|The TG level was assessed under fasted conditions.|Baseline to End Point (up to 6 months)|The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion.||mmol/L||Standard Deviation|Mean
119922|NCT00645099|Primary|Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)|Plasma fasting TG and HDL concentrations were measured to determine the TG:HDL ratio.|Baseline to End Point (up to 6 months)|The primary end point analysis set consisted of 413 patients, i.e., all patients who received study medication at least once and had baseline and post-baseline TG and HDL data. Data of patients with missing TG or HDL values or who started or changed lipid-lowering medication during the trial were excluded from analysis.||Ratio||Standard Deviation|Mean
119923|NCT00644995|Secondary|Quit Attempt|% who made a quit attempt, defined as intentionally not smoking for at least 24 hours|6 months|||percent of participants|||Number
119924|NCT00644995|Secondary|Number of Cigarettes Smoked Per Day|Mean change in cigarettes smoked per day from baseline|4 months|||mean change in number of cigs/day smoked||Full Range|Mean
119925|NCT00644995|Primary|Minutes Per Week of Vigorous Physical Activity|Mean change from baseline assessed using IPAQ physical activity scale|6 months|||minutes per week||Full Range|Mean
119926|NCT00644995|Primary|Minutes Per Week of Moderate Physical Activity|Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)|6 months|||mean change in minutes per week of PA||Full Range|Mean
119927|NCT00644995|Primary|Days Walk Per Week|Mean change in days walk per week from baseline|6 months|||mean change in days walked per week||Full Range|Mean
119928|NCT00644995|Primary|Abstinent From Smoking|self-reported 7 day point prevalent abstinence with non-responders coded as smokers|6 months|||percentage of participants|||Number
119929|NCT00644995|Primary|Depression Score|% with significant change (50% reduction in SCL [Symptom Checklist] depression score)|6 months|||percentage of participants|||Number
119930|NCT00644969|Secondary|Change From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as mean number of cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS; (n)=number of participants with evaluable data at observation.||cigarettes per day||95% Confidence Interval|Least Squares Mean
119931|NCT00644969|Secondary|Number of Participants With at Least a 50 Percent (%) Reduction From Baseline to Week 12 and Week 24 in the Number of Cigarettes Smoked Per Day|Measured as at least a 50% reduction from baseline in cigarettes smoked per day averaged over the past 7 days at Week 12 and Week 24.|Baseline, Week 12, Week 24|FAS||participants|||Number
119932|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 24|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 24 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 24|FAS||participants|||Number
119933|NCT00644969|Secondary|Number of Participants With 7-day Point Prevalence of Non-smoking at Week 12|7-day point prevalence of non-smoking measured as the number of participants who maintained complete abstinence from cigarette smoking or other nicotine use in the previous 7 days before the Week 12 visit and had an end-expiratory carbon monoxide (CO) measurement of ≤10 parts per million (ppm).|Week 12|Full analysis set (FAS): all participants randomized into the study who received at least 1 dose of study treatment (formerly referred to as the All subjects analysis set).||participants|||Number
119934|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||participants|||Number
119935|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 12|Safety analysis set; N=number of participants with analyzable data at observation.||participants|||Number
119936|NCT00644969|Primary|Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 1|Safety analysis set; N=number of participants with analyzable data at observation.||participants|||Number
120410|NCT00640315|Primary|Maximum Drug Concentration in Plasma (Cmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||µg/L||Geometric Coefficient of Variation|Geometric Mean
119937|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline to Week 24|Safety analysis set; N=number of participants with evaluable data at observation.||participants|||Number
119938|NCT00644969|Primary|Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline (Bsl) to Week 12|Safety analysis set; N=number of participants with evaluable data at observation.||participants|||Number
119939|NCT00644969|Primary|"Number of Participants With Suicidal Behavior or Suicical Ideation (Yes Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 13 to Week 24 (Post treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with new suicidal behavior and / or ideation."||participants|||Number
119940|NCT00644969|Primary|"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Week 1 to Week 12 (Treatment phase)|"Safety analysis set; N=number of participants assessed for suicidal behavior and / or ideation. Yes response includes participants with continued or new suicidal behavior and / or ideation. Treatment phase includes a 7 day lag after last dose of study treatment."||participants|||Number
119941|NCT00644969|Primary|Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
119942|NCT00644969|Primary|Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS)|10-item rating scale to assess the severity of extrapyramidal symptoms rated on a 5-point scale 0 (normal) to 4 (highest severity). Items measured are gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella tap, tremor, and salivation. Global score calculated by summing individual item scores and dividing by the total number of items; range is 0 to 40 with higher scores indicating greater severity.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
119943|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
119944|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Negative symptoms (deficit features) associated with schizophrenia (blunted affect, emotional withdrawal, poor rapport, and passive / apathetic social withdrawal) are rated on a scale from 1 (absent) to 7 (extreme); total negative subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
119945|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
120135|NCT00642603|Primary|Progression-free Survival (PFS) in U.S. Patients Only|PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.|From first patient enrolled up to approximately 48 months|This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.||months|||Number
119946|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Positive symptoms (productive symptoms) associated with schizophrenia (delusions, conceptual disorganization, and hallucinatory behavior) are rated on a scale from 1 (absent) to 7 (extreme); total positive subscale scores range from 7 to 49 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
119947|NCT00644969|Primary|Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 24|Safety analysis set; N=number of participants with analyzable data at observation.||scores on a scale||Standard Deviation|Mean
119948|NCT00644969|Primary|Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score|PANSS includes 30 items rated on a 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme) organized as 7 positive symptom subscale items, 7 negative symptom subscale items and 16 general psychopathology items. Total scores range from 30 to 210 with higher scores indicating more extreme symptoms.|Baseline to Week 12|Safety analysis set; (n)=number of participants with analyzable data at observation for varenicline and placebo, respectively.||scores on a scale||Standard Deviation|Mean
119949|NCT00644969|Primary|Number of Participants With Psychiatric Adverse Events|Psychiatric Adverse Event symptoms included, but were not restricted to, depression, anxiety, hostility, perceptual / thinking disturbance, suicidal ideation, or suicidal behavior based on clinical judgment and use of the Positive and Negative Syndrome Scale and Columbia Classification Algorithm of Suicide assessments.|Baseline up to Week 24|Safety analysis set; Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment). Neuropsychiatric events assessed through Week 24.||participants|||Number
119950|NCT00644969|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The event does not need to be causally related to the study treatment or usage. SAEs include any untoward medical occurrence that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, results in disability or incapacity or are a congenital anomaly or birth defect in the offspring of a study participant. Lack of efficacy was to be reported as an AE when it was associated with an SAE.|Baseline up to 30 days after last dose of study treatment or up to Week 16|Safety analysis set: all participants who took at least 1 dose of randomized study medication, including partial doses and had a safety measurement. Safety assessed Baseline through Week 12 (treatment phase) plus a 30 day lag period after last dose of study treatment).||participants|||Number
119951|NCT00644917|Primary|Skin Reaction Score|Scores for phototoxic skin irritation were used to evaluate safety. In this study, irritation was graded using a scale that ranged from 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units.|48 hours|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
119952|NCT00644787|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale in Double Blind Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Percentage of participants|||Number
119953|NCT00644787|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale in Titration Phase|The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 14|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
119954|NCT00644787|Secondary|Mean Number of Rescue Doses in Double Blind Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Rescue doses||Standard Deviation|Mean
119955|NCT00644787|Secondary|Mean Number of Rescue Doses in Titration Phase|Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Rescue doses||Standard Deviation|Mean
119988|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 and GMT-TIV-adj/GMT-Non Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.|On study days 1, 29, 50 , 181|The analysis was done on Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
119956|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Double Blind Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
119957|NCT00644787|Secondary|Number of Participants With Total Duration of Pain Per Day in Titration Phase|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
119958|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
119959|NCT00644787|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
119960|NCT00644787|Secondary|Percentage of Participants Achieving Pain Control in Double Blind Phase|Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain.|Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.||Percentage of participants||95% Confidence Interval|Number
119961|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||mm||Standard Deviation|Mean
119962|NCT00644787|Secondary|Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||mm||Standard Deviation|Mean
119963|NCT00644787|Secondary|Number of Participants With Response Based on Participant’s Global Assessment Scale in Double Blind Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED|The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
119964|NCT00644787|Secondary|Number of Participants With Response Based on Participant’s Global Assessment Scale in Titration Phase|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
120383|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted TLC|The percent of predicted TLC was provided by investigator at site.|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
119965|NCT00644787|Primary|Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase|The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).|Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)|Per Protocol Set (PPS) population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.||mm||Standard Deviation|Mean
119966|NCT00644787|Primary|Percentage of Participants Achieving Dose Titration Success|Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.|Day 14 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.||Percentage of participants||95% Confidence Interval|Number
119967|NCT00644657|Secondary|The Percentage of Coated Platelets After Coronary Angiography and/or PCI|The percentage of coated platelets 24 hours after coronary angiography and/or PCI|6 hrs after procedure|||Percentage of platelets that are coated||Standard Deviation|Mean
119968|NCT00644657|Primary|The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty|The percentage of platelets that are collagen coated after the administration of clopidogrel.|24 hours after the administration of clopidotrel|||Percent of platelets that are coated.||Standard Deviation|Mean
119969|NCT00644592|Primary|Log(ENA-Period 2 End/ENA Period 1 End)|"Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.~Natural logs used"|week 12 to week 4|Intent was to enroll 30 but drug was withdrawn by provider, with only 11 completing both experimental periods||Log of Ratio||Standard Deviation|Mean
119970|NCT00644332|Secondary|Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI|The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). The planned analysis was the amount of variation in WISQ and SAQ score changes from baseline explained by changes in angina frequency, NTG use, and DASI score assessed by multiple linear regression analysis.|Baseline to Week 4|Data was collected for this outcome, however, the analysis was not done.||coefficient of determination|||Number
119971|NCT00644332|Primary|Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis|Responsiveness of the WISQ was assessed as the estimated coefficient of determination (R^2) of the change from baseline WISQ Total Score at 4 weeks regressed on change from baseline angina frequency and change from baseline NTG use. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set||coefficient of determination|||Number
119972|NCT00644332|Primary|Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value|Reliability of the WISQ was assessed by estimating Cronbach's alpha (standardized); values of 0.7 or higher were to be considered adequate. (Standardized Cronbach's alpha is a coefficient of reliability or consistency, and is a function of the average inter-item correlation.) Cronbach's alpha was calculated for the WISQ instrument overall and for the Angina Frequency/Severity and Angina Stability subscales. Missing item responses were not imputed.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set||ratio of variances|||Number
119973|NCT00644332|Secondary|Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment|The DASI was analyzed as mean values at baseline and Week 4. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline to Week 4|Modified Intent-to-Treat Analysis Set||DASI scale units||Standard Error|Mean
119974|NCT00644332|Secondary|Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries|Nitroglycerin use was recorded by subjects in their diaries. Weekly frequency of NTG use was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set~Missing values were excluded"||uses per week||Standard Error|Mean
119975|NCT00644332|Secondary|Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries|Angina episodes were recorded by subjects in their diaries. Weekly frequency of angina episodes was calculated for the two-week baseline period and the last two weeks of the study.|Baseline to Week 4|"Modified Intent-to-Treat Analysis Set~Missing values were excluded"||attacks per week||Standard Error|Mean
119989|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.~Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
121796|NCT00626743|Primary|Maximal Change From Baseline in Standing SBP||within 8 hrs after SK3530 or placebo|||mmHg||Standard Deviation|Mean
119976|NCT00644332|Primary|Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2)|Validity of the WISQ was assessed by regression analysis. Results of this analysis are reported as the estimated coefficient of determination (R^2) of the WISQ Total Score at 4 weeks regressed on 4-week angina frequency, 4-week NTG use, and DASI score at 4 weeks. For mean (SEM) Baseline and Week 4 values for angina frequency and NTG use, please refer to Secondary Outcome Measures 7 and 8. For mean (SEM) Baseline and Week 4 DASI values, please refer to Secondary Outcome Measure 9.|Baseline to Week 4|Modified Intent-to-Treat Analysis Set, defined as all patients who took at least 1 dose of ranolazine and completed both baseline and postbaseline questionnaires. Partially missing questionnaire responses were imputed by the methods specified in the scoring instructions; completely missing responses were not imputed.||coefficient of determination|||Number
119977|NCT00644332|Secondary|Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set||SAQ scale units||95% Confidence Interval|Number
119978|NCT00644332|Secondary|Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in stress, excitement, temperature, satiety, anger, and other limitation items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 27 points (higher=more severe state); SAQ items: 45 points (lower=more severe state). WISQ scores were recalibrated by multiplying by 15/27. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set||SAQ scale units||95% Confidence Interval|Number
119979|NCT00644332|Secondary|Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment|Changes from BL in angina frequency items following ranolazine treatment were measured. Analysis: multiple linear regression; response variable: ΔWISQ – ΔSAQ; independent variables: age and BL WISQ and SAQ scores. WISQ items: 15 points (higher=more severe state); SAQ items: 12 points (lower=more severe state). WISQ scores were recalibrated by multiplying by .75. Noninferiority was to be considered demonstrated if the lower limit of a 2-sided 95% CI for WISQ mean – SAQ mean was above the prespecified margin (WISQ vs SAQ difference of -2).|Baseline to 4 Weeks|Modified Intent-to-Treat Analysis Set||ratio of variance||95% Confidence Interval|Number
119980|NCT00644280|Secondary|Significant Ocular Adverse Events|Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment|6 months|||participants|||Number
119981|NCT00644280|Primary|Tube Success at 6 Months|Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication.|6 months|||percentage of participants|||Number
119982|NCT00644059|Secondary|Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months||3 weeks after 2nd vaccination|Adequate data was not available for assessing the incidence rates of the 2009-2010 swine pandemic caused by a novel influenza A (H1N1) virus of swine origin.|||||
119983|NCT00644059|Secondary|Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child||3 weeks after 2nd vaccination|As per an amendment to the protocol, the Secondary efficacy endpoints were evaluated in enrolled subjects only and the household members were not included in the trial for the evaluation of indirect vaccine efficacy.|||||
119984|NCT00644059|Secondary|Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons||7 days post-vaccination|Adequate data was not available to conduct this analysis.|||||
119985|NCT00644059|Secondary|Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)|"HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.~Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
119986|NCT00644059|Secondary|Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains|"Hemagglutination Inhibition (HI) assay was used for the analysis.~Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%."|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
119987|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.~The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
119990|NCT00644059|Secondary|Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)|Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.|On study days 1, 29, 50, 181|The analysis was done on Full Analysis Set||Percentage of subjects||95% Confidence Interval|Number
119991|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)|"Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points.~Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set||Titers||95% Confidence Interval|Geometric Mean
119992|NCT00644059|Secondary|Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)|"The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.~The criteria for evaluation is GMR >2.5"|On study days 1, 29, 50 and 181|The analysis was done on Full Analysis Set||Ratios||95% Confidence Interval|Geometric Mean
119993|NCT00644059|Secondary|Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.|The number of events of Influenza like Illness reported by subjects aged 6 to <72 months was assessed for combined seasons 2007/08 and 2008/09|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set||Events||Standard Deviation|Mean
119994|NCT00644059|Secondary|Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set||Days||Standard Deviation|Mean
119995|NCT00644059|Secondary|Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set||Number of subjects|||Number
119996|NCT00644059|Secondary|Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09|Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to <72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set||Number of subjects|||Number
119997|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).|"Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.~For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set||Percentage of subjects|||Number
119998|NCT00644059|Secondary|Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)|"Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.~For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control."|3 weeks after 2nd vaccination|The analysis was done on Full Analysis Set||Percentage of subjects|||Number
119999|NCT00644059|Secondary|Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination|Number of subjects aged 6 to <36 months and in the overall age cohort (unprimed children aged 6 to <72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study|Study day 1 to Study day 181|The analysis was done on Safety set||Number of subjects|||Number
120000|NCT00644059|Secondary|Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination|Safety was assessed as the number of subjects aged 6 to <72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.|7 days post-vaccination|The analysis was done on Safety set||Number of subjects|||Number
120001|NCT00644059|Primary|Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)|Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to <36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.|3 weeks after 2nd vaccination|Analysis was done on Full Analysis Set (FAS) - All subjects in the enrolled set who received study vaccination and provided at least one evaluable serum sample both before and after baseline.||Percentage of subjects|||Number
120002|NCT00644059|Primary|Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.|Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.|7 days post-vaccination|The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.||Number of subjects|||Number
121797|NCT00626639|Secondary|Overall Survival||During long-term follow-up phase, until December 2015||12/2016||||
120003|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests|All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
120004|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
120005|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
120006|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
120007|NCT00643201|Secondary|Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|N=Treated participants who received at least one dose of study drug and had non-missing laboratory measurements.||participants|||Number
120008|NCT00643201|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants|Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued|Total number of participants receiving at least one dose of study drug. Participants were categorized according to the actual treatment received.||participants|||Number
120009|NCT00643201|Secondary|Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 402/2676; 676/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
120029|NCT00643916|Primary|Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.||Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2|Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Percentage of Participants|||Number
120010|NCT00643201|Secondary|Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 313/2676; 505/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
120011|NCT00643201|Secondary|Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 103/2676; 215/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
120012|NCT00643201|Secondary|Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants|Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 115/2676; 261/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
120013|NCT00643201|Secondary|Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants|All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants receiving at least one dose of study drug n/N: 15/2676; 49/2689, in apixaban and enoxaparin/warfarin groups, respectively. CI for event rate calculated based on Wald asymptotic confidence limits. Participants were categorized according to the actual treatment received.||proportion of participants||95% Confidence Interval|Number
120014|NCT00643201|Secondary|Incidence of All-Cause Death During the Intended Treatment Period|Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants excluding those with missing endpoint (n/N: 41/2608; 52/2630). Events included regardless of whether or not participant received treatment, ie, ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120015|NCT00643201|Secondary|Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective groups excluding those with missing endpoint information (n/N: 15/2608; 23/2630). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120384|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity (TLC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120016|NCT00643201|Secondary|Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period|VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).|Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)|Total number of participants in respective treatment groups excluding participants with missing endpoint information. (n/N: 12/2608; 16/2630). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120017|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period|PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 27/2606; 25/2632). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120018|NCT00643201|Secondary|Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period|DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm (ITT), excluding those with missing endpoint (n/N: 22/2608; 35/2633). CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120019|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding|VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number participants in each treatment group, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 183/2617; 333/2641). Events included as per ITT principle. CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120020|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|Total number of participants in each randomized arm, excluded those with missing endpoint and included those not in the efficacy evaluable population with bleeding event which occurred during treatment (n/N: 73/2610; 118/2635). Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120030|NCT00643760|Secondary|Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
120385|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of FEV1/FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120021|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 61/2609; 77/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. CI for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120022|NCT00643201|Secondary|Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death|VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.|Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)|All randomized participants with non-missing secondary endpoint (n/N: 84/2609; 104/2635, in apixaban, enoxaparin/warfarin arms, respectively). Participants categorized to assigned arm, regardless of treatment actually received. Intent to Treat principle. Confidence interval (CI) for event rate calculated based on Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120023|NCT00643201|Primary|Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment|VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).|Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)|All randomized participants with a non-missing primary endpoint (n/N: 59/2609; 71/2635, in apixaban, enoxaparin/warfarin, respectively). Intent-to-treat population. Confidence interval (CI) for event rate calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
120024|NCT00643097|Secondary|Toxicity to PEP-3 Vaccine Immunization|To assess for any potential toxicity to the PEP-3 vaccine immunization in patients with newly diagnosed glioblastoma, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to tabulate any toxicities attributable to PEP-3. The number of patients with toxicity attributable to vaccine while on study are tabulated.|26 months|||participants|||Number
120025|NCT00643097|Secondary|Response to Vaccination|The objective is to assess the duration of immunosuppressive cytokine secretion and to identify a receptive interval for active immunotherapy. Immunosuppression will determined by monitoring a panel of immunosuppressive serum/plasma cytokines longitudinally and by determining the response of each patient to Recombivax Hepatitis B (HB) vaccination. Response is defined as seropositive or seronegative to the Hepatitis B surface antigen.|26 months|This objective was not completed, as the test was not performed successfully.||Months||Standard Deviation|Mean
120026|NCT00643097|Primary|Clinical Efficacy of Vaccination, in Terms of Progression-free Survival (PFS)|"Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.~Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator)."|58 months|||months||95% Confidence Interval|Median
120027|NCT00643097|Primary|Humoral and Cellular Immune Response|Number of patients that developed a delayed-type hypersensitivity (DTH) response at following vaccination. Any skin reaction in response to the intradermal injection of the antigen was measured and recorded. A positive skin test was defined as > 5 mm induration (swelling).|26 months|The test was performed on a subset of patients in each group that were available at vaccine 8, and results posted for those 30 patients who had the tests performed.||participants|||Number
120028|NCT00643916|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.|Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.|Day 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.||Percentage of participants|||Number
121798|NCT00626639|Primary|Pharmacokinetics of Palifermin|Due to the small sample size this analysis was not performed.|Day -3, predose and at 2, 5, 15, 30, 60, and 90 minutes and 2, 4, 6, 8, 10, 12, 24 and 48 hours after the first dose||||||
120031|NCT00643760|Secondary|Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
120032|NCT00643760|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
120033|NCT00643760|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Any time post-baseline until date of last dose of study medication (up to Week 13)|ITT Population||days||Full Range|Median
120034|NCT00643760|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||participants|||Number
120035|NCT00643760|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants had a CGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||participants|||Number
120036|NCT00643760|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a PGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||participants|||Number
120037|NCT00643760|Secondary|Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT|Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a 50-foot walk at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
120038|NCT00643760|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-MPQ assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
120076|NCT00643565|Secondary|Duration of Response|Duration of Response was defined as time between first objective response and the occurrence of an EFS event (described in Outcome Measure 1). Objective response was defined in Outcome Measure 3. Median duration of response was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||months||95% Confidence Interval|Median
120039|NCT00643760|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an NPS assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||scores on a scale||Standard Error|Least Squares Mean
120040|NCT00643760|Secondary|Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||milligrams||Standard Error|Least Squares Mean
120041|NCT00643760|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
120042|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
120043|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
120044|NCT00643760|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
120045|NCT00643760|Secondary|Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a current (morning) pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
120046|NCT00643760|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate an average night-time pain intensity score for the EOMT timepoint.||scores on a scale||Standard Error|Least Squares Mean
120047|NCT00643760|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
120048|NCT00643760|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population||scores on a scale||Standard Error|Least Squares Mean
120049|NCT00643682|Secondary|Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.|The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous.|2 years|||participants who had a colonoscopy|||Number
120050|NCT00643682|Secondary|Time to Withdraw Colonoscope From Tip of Cecum to Anus.|Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy|2 years|||Time in minutes||Inter-Quartile Range|Median
120051|NCT00643682|Secondary|Time to Advance Colonoscope From Anus to Tip of Cecum.|time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.|2 years|||time in minutes||Inter-Quartile Range|Median
120052|NCT00643682|Primary|Boston Bowel Preparation Scale Score|An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922|2 years|||units on a scale||Inter-Quartile Range|Median
120053|NCT00643604|Secondary|Patient Impression of Change Questionnaire|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.||participants|||Number
120054|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
120055|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
120056|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
120057|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
120058|NCT00643604|Secondary|Change in Signs and Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
120059|NCT00643604|Secondary|Change From in Signs and Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline and Week 8|||participants|||Number
120060|NCT00643604|Secondary|Change in PAH Signs and Symptoms- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||participants|||Number
120061|NCT00643604|Secondary|Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin. Drug Administration Activities Diary results are reported as average time per week spent on drug administration activities|Baseline and Week 8|"Two subjects did not have Week 8 Drug Administration Activity Diaries completed.~Connect Drug and Total Time Components: N=4; One subject did not have data recorded for Connect drug activities. Total time could not be calculated for this subject."||minutes||Standard Deviation|Mean
120062|NCT00643604|Secondary|Change in Score on Treatment Satisfaction Questionnaire for Medication|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua(e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to completing the Week 8 visit.||units on a scale||Standard Deviation|Mean
120386|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FVC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120063|NCT00643604|Secondary|Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and Week 8|Two subjects with a Week 8 visit outside of the visit window are included in the summary. One subject died prior to completing the Week 8 visit. One subject had an incomplete Baseline questionnaire and the CAMPHOR Activity component could not be calculated, therefore N=5 Activity and Total Score Components, and N=6 for Symptom and Quality of Life.||units on a scale||Standard Deviation|Mean
120064|NCT00643604|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk|The Borg Dyspnea Score is a 10-point scale rating the maximum level of dyspnea experienced after the Six-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||units on a scale||Standard Deviation|Mean
120065|NCT00643604|Secondary|Change in WHO Functional Classification|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||participants|||Number
120066|NCT00643604|Primary|Change in Six Minute Walk Distance||Baseline and Week 8|Two subjects had a Week 8 visit that was outside of the visit window and are included in the summary. One subject died prior to Week 8 assessments.||meter||Standard Deviation|Mean
120067|NCT00643578|Secondary|FEV1|The forced expiratory volume in the first second, expressed as a percent predicted.|1 hour after dose|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.||percent predicted||Standard Deviation|Mean
120068|NCT00643578|Primary|Post-dose PC20|The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.|3-7 days after visits 1 and 2|Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.||mg/mL||95% Confidence Interval|Geometric Mean
120069|NCT00643565|Secondary|Clearance of Bevacizumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL is expressed in milliliters per day (mL/day).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.||mL/day||Standard Deviation|Mean
120070|NCT00643565|Secondary|Half-Life of Bevacizumab|Half-life is the time measured for the plasma concentration to decrease by one half.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.||days||Standard Deviation|Mean
120071|NCT00643565|Secondary|Volume of Distribution of Bevacizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)|PK-evaluable population. Only participants who received bevacizumab were to be analyzed for PK assessment.||mL||Standard Deviation|Mean
120072|NCT00643565|Secondary|Area Under the Curve at Steady State (AUCss) of Bevacizumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCss is expressed in milligrams times days per milliliter (mg*day/mL).|Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase|Pharmacokinetic (PK)-evaluable population included all randomized participants for whom at least one blood sample was taken for PK assessment following bevacizumab administration. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||mg*day/mL||Standard Deviation|Mean
120073|NCT00643565|Secondary|Overall Survival Duration|Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Median overall survival was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||months||95% Confidence Interval|Median
120074|NCT00643565|Primary|EFS Duration as Per IRC Assessment|EFS was defined as the time between randomization and occurrence of EFS event. EFS events are described in Outcome Measure 1. Median EFS was estimated using Kaplan-Meier estimates and 95% confidence intervals (CI) for median was computed using the method of Brookmeyer and Crowley.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||months||95% Confidence Interval|Median
120075|NCT00643565|Secondary|Percentage of Participants Who Died||Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||percentage of participants|||Number
120077|NCT00643565|Secondary|Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response|EFS events was described in Outcome Measure 1 and Outcome Measure 3.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population. Here number of participants analyzed = participants available for the analysis of this outcome measure.||percentage of participants|||Number
120078|NCT00643565|Secondary|Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria|Objective response prior to first local therapy (surgery and/or radiotherapy) was defined as complete response (CR) or partial response (PR) determined on two consecutive occasions >/=4 weeks apart. Tumor response was assessed as per IRC using RECIST v1.0. CR was defined as disappearance of all target and non-target lesions. If immunocytology was available, no disease was to be detected by that methodology. PR was defined as at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.|Screening up to approximately 6.75 years (data cut-off date 31 May 2015)|ITT population.||percentage of participants||95% Confidence Interval|Number
120079|NCT00643565|Primary|Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment|EFS events included tumor progression (IRC assessed), no evidence of response after 3 cycles of induction (derived from IRC assessment), second primary cancer, or death due to any cause. Data for participants who had not experienced an event by the time of clinical cut-off were censored at the date of the last disease assessment prior to the clinical cut-off date. Data for participants who did not have any post-baseline disease assessments were censored at the time of randomization. Tumor progression was defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions.|Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years up to data cut-off date 31 May 2015)|ITT population.||percentage of participants|||Number
120080|NCT00643487|Primary|Number of Participants With Successful Recording.|Observe the behavior of the IPP of the knee by fluoroscopy. A complete recording was obtained in 2 patients: this implied that the plica,central body, and fat pad were visualized. The patients then completed a series of manouevres which demonstrated the mechanical behavior of the infrapatellar plica-fat pad complex.|During procedure, on average one hour.|||Participants|||Number
120081|NCT00643448|Secondary|Compliance With Trans Telephonic Monitoring (TTM)|Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis|During treatment days 1-10|||Percentage of recordings analysed||Full Range|Mean
120082|NCT00643448|Secondary|Estimated Cmax (Maximum Plasma Concentration) (PK Modeling) at Steady-state|Population PK model parameter estimates derived from plasma concentrations of AZD1305|During treatment days 1-10|||μmol/L||Full Range|Mean
120083|NCT00643448|Secondary|Adverse Events (AE)|Number of patients who had at least one AE according to the definition in the study protocol|During treatment days 2-10|||Participants|||Number
120084|NCT00643448|Primary|Maximum QTcF|Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.|During treatment days 2-10|||ms||Full Range|Mean
120085|NCT00643006|Primary|Change of Pain Level From Baseline.|Pain was measured by The Fibromyalgia Impact Questionnaire (FIQ) subscale for Pain, which is a self-rated pain on visual analogue scale, 0-100 mm. The higher value, the worse pain.|15 weeks|Patients attending at post-test||mm||Standard Deviation|Mean
120086|NCT00643006|Primary|Six-minute Walk Test|Patient is instructed to walk as fast as she can. The distance covered during 6 minutes is documented.|15 weeks|||meter||Standard Deviation|Mean
120087|NCT00642993|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at Week 12|"For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.~Per protocol, participants were either obese (BMI ≥30 kg/m^2 and ≤40 kg/m^2) or overweight (BMI ≥27 kg/m^2 and <30 kg/m^2) at enrollment."|Baeline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||kg/m^2||Standard Error|Mean
120088|NCT00642993|Secondary|Mean Change From Baseline in Waist Circumference at Week 12|Participant's waist circumference was measured in centimeters. For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Centimeters||Standard Error|Mean
120089|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Percentage of participants|||Number
120090|NCT00642993|Secondary|Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12|For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Percentage of participants|||Number
120091|NCT00642993|Primary|Mean Change From Baseline in Body Weight at Week 12|Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.|Baseline and Week 12|Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.||Kilogram||Standard Error|Mean
120387|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Vital Capacity (FVC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120092|NCT00642902|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.|From the first dose of study drug administration up to 12 weeks after the last dose of the study drug|Safety population included all participants who received at least 1 dose of treatment (either active or placebo).||participants|||Number
120093|NCT00642902|Secondary|Percentage of Participants Free From Relapses|A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature [axillary, orally, or intrauriculary] greater than (>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant’s reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.|Baseline up to Week 36|ITT population included all randomized participants.||percentage of participants|||Number
120094|NCT00642902|Secondary|Number of New T1 Gd-enhancing Lesions Per Participant|Analysis of new T1 Gd-enhancing lesions was done using MRI scans.|Weeks 12, 24, 36|ITT population included all randomized participants. 'n' signifies participants who were evaluable for this measure at given time points for each group, respectively.||lesions/participant||Standard Deviation|Mean
120095|NCT00642902|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan|Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).|Weeks 12 to 36|ITT population included all randomized participants.||lesions/participant/scan||95% Confidence Interval|Mean
120096|NCT00642850|Secondary|Number of Participants With Anti-epoetin Antibody||Week -4 and at early withdrawal or Week 28|ITT Population.||participants|||Number
120097|NCT00642850|Secondary|Number of Participants With Red Blood Cell Transfusion During the Study|Number of participant who underwent red blood cell transfusion during the study was reported.|Week -4 up to Week 28|ITT Population.||participants|||Number
120098|NCT00642850|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 to Week 16 and Week 17 to Week 24|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable for specified category.||percentage of participants|||Number
120099|NCT00642850|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.||days||Standard Deviation|Mean
120100|NCT00642850|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.|Week 17 up to Week 24|ITT Population.||percentage of participants||95% Confidence Interval|Number
120101|NCT00642850|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.|Week -4 up to Week -1 and Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who had received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least 1 follow-up variable had been available.||g/dL||Standard Deviation|Mean
120102|NCT00642850|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range|Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|Per protocol (PP) population included all participants in the safety population with the exception of participants with less than 3 recorded hemoglobin values, missing administrations of C.E.R.A., withdrawal, inadequate iron status in Weeks 16-24.||percentage of participants||95% Confidence Interval|Number
120103|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
120130|NCT00642642|Primary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) and four months after last treatment|Analysis population was the ITT population, defined as subjects for whom product could be produced and who were randomized to study treatment, whether or not all study treatments are actually received.||Participants|||Number
120104|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Clopidogrel to Clopidogrel Versus Clopidogrel to Ticagrelor on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
120105|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 28|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|4 hrs post first dose on day 28|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
120106|NCT00642811|Secondary|Clopidogrel Responders Final Extent IPA Post Switching Treatment - Comparing Ticagrelor to Ticagrelor Versus Ticagrelor to Clopidogrel on Day 15|IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. Please refer to the protocol section for details about the interventions administered.|Day 15, 4 hrs post switching|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percent||95% Confidence Interval|Least Squares Mean
120107|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.|The secondary definition of response to treatment is IPA >50% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14, and day 28, 4 hours post dose|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.||Percent of participants|||Number
120108|NCT00642811|Primary|Proportion of Clopidogrel Non-responders Who Responded to Clopidogrel or Ticagrelor. - Comparing Ticag. (Day 28 of Clop. to Ticag., and Day 14 of Ticag. to Clop.) Versus Clop. (Day 14 of Clop. to Ticag., and Day 28 of Ticag. to Clop.)|The primary definition of response to treatment is IPA >10% post treatment. The response is reported as percentage of participants of each treatment. Please refer to the protocol section for details about the interventions administered. IPA(%)=(PAb-PAt)/PAb*100. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|Day 14 and Day 28, 4 Hrs Post Dose.|Intent-to-treat analysis set: included patients who were assigned to a cohort, randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data. 32 subjects had IPA data; but 1 subject missing a treatment arm, did not qualify for McNemar's test.||Percent of Participants|||Number
120109|NCT00642772|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|Self-report measure of pain (5 items), stiffness (2 items) and function (17 items) in lower extremity osteoarthritis. All items were measured on a 5-point likert scales, with higher scores indicating worse pain, stiffness, or functional limitations. Total WOMAC score ranges from 0-96.|Baseline and Following 12-Week Intervention|||units on a scale||Standard Deviation|Mean
120110|NCT00642759|Secondary|To Determine the Overall Survival in the Study Population.||3 years||||||
120111|NCT00642759|Secondary|To Determine the Objective Response Rate to Carboplatin, Abraxane and Avastin in the Study Population.||3 years||||||
120112|NCT00642759|Secondary|To Determine the Safety and Tolerability of Carboplatin, Abraxane, and Avastin in the Study Population.||3 years||||||
120113|NCT00642759|Primary|To Determine the 6-month Progression Free Survival Rate in the Study Population.||3 years|||percentage||95% Confidence Interval|Number
120114|NCT00642746|Secondary|Time to Second Progression (From Start of First-Line Regimen)|"Number of days from the initiation of first line treatment to first documented progression. Progression will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.~Progression free survival (time to progression or death, whichever occurs first) is the same as time to progression as all of the patients in this trial progressed."|Documented by Follow-up CT scans following first line treatment, average of 225 days.|95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient.||Days||95% Confidence Interval|Median
120131|NCT00642616|Secondary|Change in HbA1C From Baseline to Week 52||Baseline, week 52|Only two participants completed both time points (one in the Usual Care (Asthma) Arm and one in the Usual Care (COPD) Arm); data are not provided due to privacy concerns|||||
120132|NCT00642616|Secondary|Number of Participants With COPD Exacerbation by Treatment Arm|Number of participants who experienced worsening of COPD symptoms|Baseline to Week 52|Safety population: Participants who received at least one dose of study medication. The outcome applies only to participants with underlying COPD||participants|||Number
120115|NCT00642746|Secondary|Second-line Progression Free Survival|Time to disease progression from start of second-line experimental regimen. Disease progression will be measured per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Upon completion of follow-up, for an average of 99 days following the initiation of study treatment.|"Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.~95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient."||Days||95% Confidence Interval|Median
120116|NCT00642746|Primary|Response Rates of Radiographically Measurable Disease|The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Disease response assessed after every 2 Treatment Cycles, or around 8 weeks.|Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator.||Number of Patients|||Number
120117|NCT00642707|Primary|Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.||Log10copies/HIV-1 RNA/mL||Standard Deviation|Mean
120118|NCT00642694|Secondary|Hamilton Rating Scale for Depression 17-item||12 Weeks||||||
120119|NCT00642694|Secondary|Psychosocial Measures i.e. SF Health Survey, QLESQ, Social Adjustment Scale Self Report, Work and Social Adjustment Scale, Work Productivity and Activity Impairment Questionaire, and the Patients Perception of Benefits of Care.||12 Weeks||||||
120120|NCT00642694|Secondary|Sleep Latency|Number of minutes until fell asleep|12 weeks|Number of Participants with analyzable data for this outcome measure||minutes||Standard Deviation|Mean
120121|NCT00642694|Primary|Percentage of Remitters on IDS-C30 at Week 12|Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity|12 Weeks|Participants who were randomized to treatment and completed Week 12 were included in analyses||percentage of participants|||Number
120122|NCT00642668|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Weeks 1-40|The safety population included all participants who received at least one dose of active drug.||percentage of participants|||Number
120123|NCT00642668|Secondary|Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.||days||Standard Deviation|Mean
120124|NCT00642668|Secondary|Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)||Weeks 29-36|ITT population included all participants who entered the titration period and received active drug.||percentage of participants||95% Confidence Interval|Number
120125|NCT00642668|Secondary|Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)|The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.|Weeks 0-36|ITT population included all participants who entered the titration period and received active drug.||grams/deciliter (g/dL)||Standard Deviation|Mean
120126|NCT00642668|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range|The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.|Weeks 29-36|Intent-to-Treat (ITT) population included all participants who entered the titration period and received active drug.||percentage of participants||95% Confidence Interval|Number
120127|NCT00642642|Secondary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Analysis was performed on the ITT population||Cheeks|||Number
120128|NCT00642642|Secondary|Evaluator Live Acne Scarring Assessment Responders|Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.|Baseline (prior to first treatment) compared to one, two, and three months after last treatment|Number of cheeks for analysis was the ITT population||Participants|||Number
120129|NCT00642642|Primary|Subject Live Acne Scarring Assessment Responders|Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.|Baseline (prior to first treatment) and four months after last treatment|Analysis was performed on the ITT population||Cheeks|||Number
125630|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Renal/Genitourological’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
120136|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4|Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 4 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.||percentage of participants|||Number
120137|NCT00642473|Primary|Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2|Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.|After 2 weeks of metronidazole treatment|All enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome in respective arms.||percentage of participants|||Number
120138|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions.|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120139|NCT00642460|Secondary|Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260|Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.|Every 2 weeks from Week 104 to 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120140|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120141|NCT00642460|Secondary|Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120142|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits|"There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:~Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day"|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120143|NCT00642460|Secondary|Part III: Percentage of Participants in Clinical Remission|"Patients who previously withdrew are excluded Responders are patients who met all of the following criteria for inactive disease at all visits in the 6 months (180 days) prior to and including the visit assessment day: i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.~iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA. v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex.~vi. iv. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS. ESR = Erythrocyte Sedimentation Rate. VAS = Visual Analogue Scale. Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120154|NCT00642460|Secondary|Part II: Percentage of Participants With no Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The percentage of participants with no signs of active arthritis is reported.|Week 104|The Intent to Treat population in Part II includes 112 participants who received at least one dose of study drug. Only those participants who reached this time point are included in the analyses.||Percentage of Participants|||Number
120155|NCT00642460|Secondary|Part II: Number of Active Joints at Week 104|Seventy-one joints were assessed for signs of active arthritis. The mean number of joints with signs of active arthritis is reported.|Week 104|Participants from the Intent to Treat population who reached this time point. No data imputation is applied and patients with missing data are excluded.||Active Joints||Standard Deviation|Mean
120144|NCT00642460|Secondary|Part III: Percentage of Participants With Inactive Disease|"Participants who previously withdrew are excluded.~Responders are participants who met all of the following criteria for inactive disease at the visit assessment day:~i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.~iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA.~v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex. vi. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS.~Data presented up to the point of entry into the Alternative Dosing Schedule."|Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120145|NCT00642460|Secondary|Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.~Baseline considered first dose of study treatment."|Every 2 weeks from Week 104 to Week 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120146|NCT00642460|Secondary|Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|"Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.~Baseline considered first dose of study treatment. Data presented up to entry into the Alternative Dosing Schedule."|Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260|ITT3 population; n=number of participants contributing to the specific statistic||percentage of participants|||Number
120147|NCT00642460|Secondary|Part III: Doses of Oral Corticosteroids|Oral corticosteroid values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the the visit of withdrawal and all subsequent visits.|Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|ITT3 population; n=number of participants contributing to the specific statistic||mg/kg/day||Standard Deviation|Mean
120148|NCT00642460|Secondary|Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week|JIA ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III ITT3 population||percentage of participants|||Number
120149|NCT00642460|Secondary|Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR|Percentage of participants with ≥30%, 50%, 70%, and 90% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.|Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260|The Part III intent-to-treat (ITT3) population consists of all participants who entered into Part III of the study and received at least one administration of tocilizumab during Part III.||percentage of participants|||Number
120150|NCT00642460|Secondary|Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104|"Rate of SAEs, Rate of Serious Infection AEs, Rate of Related SAEs (remotely, possibly, probably) to Tocilizumab (TCZ), Rate of Macrophage Activation Syndrome, Rate of AEs leading to withdrawal and Rate of deaths per 100 patient years (PY) were calculated using the formula:~Number of Patient Events / Duration in study (years) * 100.~Multiple occurrences of the same AE in one individual are counted."|104 Weeks|Safety Population- all participants who received at least one dose of study drug and had 1 post-baseline safety assessment. Includes all safety data in the database up to the week 104 infusion based on the date of randomization for each patient. (Last date was 31 May 2011)||Events per 100 patient year|||Number
120151|NCT00642460|Secondary|Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104|Percentage is based on only those participants who were on oral corticosteroid at baseline and reached a nominal visit day on which dose was calculated.|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.||Percentage of Participants|||Number
120152|NCT00642460|Secondary|Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).~The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 104|Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.||Score on a scale||Standard Deviation|Mean
120153|NCT00642460|Secondary|Part II: Percentage of Participants With Inactive Disease at Week 104|"Criteria for Inactive Disease:~1) No joints with active arthritis, 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal Erythrocyte Sedimentation Rate (<20 mm/hour), 4) Physician’s global assessment of disease activity Visual Analog Scale (VAS) indicates no disease activity (where no disease activity is considered to be a score ≤10 mm on a 100 mm VAS)."|Week 104|Participants from the Intent to Treat population who reached time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been nonresponders.||Percentage of Participants|||Number
120156|NCT00642460|Secondary|Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104|"The six JIA ACR components consist of: 1)Physician's global assessment of disease activity, 2)Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.~At an assessment visit a JIA ACR70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 104|Participants from the Intent to Treat population who reached the time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been non-responders.||Percentage of Participants|||Number
120157|NCT00642460|Secondary|Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12|Part I: Percentage of patients who had anemia (hemoglobin <lower level normal based on sex and age) at Baseline and a ≥10 g/L increase in hemoglobin at Week 6 and at Week 12.|Baseline, Week 6 and Week 12|"Participants from the Intent-to-treat population for whom hemoglobin data available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.~LOCF rule applied to missing hemoglobin values at Week 6 and Week 12."||Percentage of participants|||Number
120158|NCT00642460|Secondary|Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12|Percentage of participants who had a rash characteristic of sJIA in the 14 days prior to the baseline visit but no rash characteristic of sJIA in the 14 days preceding the Week 12 visit day.|Baseline, Week 12|Participants from the Intent-to-treat population for whom data was available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.||Percentage of participants|||Number
120159|NCT00642460|Secondary|Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12|"Percentage of patients who had at least a 0.13 improvement in CHAQ-DI score from Baseline to Week 12.~The CHAQ-DI questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do)."|Baseline, Week 12|"Intent-to-treat Population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.~LOCF rule applied to missing CHAQ-DI Scores at Week 12."||Percentage of participants|||Number
120160|NCT00642460|Secondary|Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12|Participants rated their pain by placing a horizontal line on a Visual Analog Scale on a scale of 0 (no pain)- 100 mm (severe pain). The score at 12 weeks minus the score at baseline. A negative number indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population who had Pain VAS data available at baseline and week 12. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing pain VAS at Week 12.||mm|||Number
120161|NCT00642460|Secondary|Part I: Percentage of Participants With Concomitant Corticosteroid Reduction|"The percentage of participants receiving oral corticosteroids(CS) with a JIA ACR70 response at week 6 or Week 8 who reduced their oral CS dose by at least 20% without subsequent JIA ACR30 flare or occurrence of systemic symptoms at week 12.~At an assessment visit a JIA ACR70 response is defined as: At least three of the six JIA ACR core components improving by at least 70% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Week 6 or Week 8, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who were taking oral corticosteroids.||Percentage of participants|||Number
120162|NCT00642460|Secondary|Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12|Percentage of participants with a change from an elevated hsCRP value at baseline to a normal hsCRP value at week 12; a change from anemia (low Hemoglobin) at baseline to a normal hemoglobin value at week 12; a change from thrombocytosis (elevated platelets) at baseline to a normal platelet value at week 12; a change from leukocytosis (elevated white blood cell count) at baseline to a normal white blood cell count at week 12.|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug. 'n' in each of the categories is the number of participants with data available at baseline and week 12 for analyses.||Percentage of participants|||Number
120163|NCT00642460|Secondary|Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12|Fever free was defined as no diary temperature recording ≥37.5° Celsius in the preceding fourteen days.|Baseline, Week 12|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who had a fever due to Systemic Juvenile Idiopathic Arthritis at baseline.||Percentage of participants|||Number
120164|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)|"Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).~The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst)."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
120165|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured in mm/hour.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
120178|NCT00642304|Secondary|Percentage of Participants With Blood Transfusion||Baseline up to Week 28|ITT population||Percentage of participants|||Number
120166|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement|The maximum number of joints with limitation of movement is 67 and these are defined as those in the joint assessment with ‘limitation of motion’.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
120167|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis|"The maximum number of joints with active arthritis is 71 and these are defined as those in the joint assessment with: swelling present or pain present and limitation of motion.~The joint assessment is performed by an independent assessor, who is not the treating physician, blinded to all other aspects of the patient’s efficacy and safety data."|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
120168|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being|The Parent/Patient global assessment of overall well-being is a VAS. The scale is a 0 to 100 mm horizontal scale, the extreme left end of the line represents ‘very well’ (i.e. symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (i.e. maximum arthritis disease activity). This item is completed by the patient or parent/guardian as appropriate.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
120169|NCT00642460|Secondary|Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity|Physician's Global Assessment of disease activity is a Visual Analog Scale. The scale is 0 to 100 mm horizontal scale, the extreme left end of the line represents ‘arthritis inactive’ (i.e. symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. This item is completed by the treating physician.|Baseline, Week 12|Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. Last observation carried forward (LOCF) rule applied to missing JIA ACR core set components at Week 12.||Percentage change|||Number
120170|NCT00642460|Secondary|Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12|"The six JIA ACR components consist of: 1) Physician's global assessment of disease activity, 2) Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.~At an assessment visit a JIA ACR30/50/70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 30%/50%/70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Week 12|Intent-to-treat population includes all randomized participants who received at least one dose of study drug.||Percentage of participants|||Number
120171|NCT00642460|Primary|Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104|Percentage of participants with ≥20 percent, ≥50 percent, ≥75 percent and ≥90 percent decreases in oral corticosteroid dose (mg/kg/day) from baseline.|Baseline, Week 104|Includes only participants on oral corticosteroids at baseline.||Percentage of participants|||Number
120172|NCT00642460|Primary|Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever|"Percentage of participants with ≥30% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity Visual Analog Scale (VAS), 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) consisting of 30 questions in 8 domains.~Absence of fever was defined as no diary temperature recording ≥37.5° Celsius in the preceding seven days."|Baseline, Week 12|Intent-to-treat population includes all participants who had at least one dose of study drug.||Percentage of participants|||Number
120173|NCT00642369|Primary|Percentage of Rapid Eye Movement Sleep|The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).|28 days|For the need of the statistical analysis, the study group and the control group are 30 evaluable patients respectively. Finally, in consideration of 25% un-evaluable patients after randomisation, there should be 80 patients randomised in this study with 40 patients per arm.||percentage of rapid eye movement sleep||Standard Deviation|Mean
120174|NCT00642369|Primary|Percentage of Slow Wave Sleep|The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).|28 days|||percentage of slow wave sleep||Standard Deviation|Mean
120175|NCT00642356|Secondary|Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy||Units on a scale||Standard Deviation|Mean
120176|NCT00642356|Primary|Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)|The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson’s disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from “not present” to “very severe”. The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline to 15 minutes prior to 2nd dose at Week 8|All subjects that were assessed for efficacy||Units on a scale||Standard Deviation|Mean
120177|NCT00642304|Secondary|Percentage of Participants With Dose Adjustment|A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.|Baseline up to Week 20|ITT population||Percentage of participants|||Number
120181|NCT00642304|Secondary|Mean Change in Hb Concentration Between SVP and the EEP|The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.|SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)|ITT population||g/dL||Standard Deviation|Mean
120182|NCT00642304|Primary|Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)|The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.|EEP (Weeks 16 to 24)|The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.||Percentage of participants||95% Confidence Interval|Number
120183|NCT00642278|Secondary|Percent Change in Body Weight From Baseline to Week 12|The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percent change||Standard Deviation|Mean
120184|NCT00642278|Secondary|Absolute Change in Body Weight From Baseline to Week 12|The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||kg||Standard Deviation|Mean
120185|NCT00642278|Secondary|Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12|The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||mg/mg||Standard Deviation|Mean
120186|NCT00642278|Secondary|Percentage of Patients With Symptoms of Hypoglycemia|The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12.|Up to Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomiy assigned to a treatment group.||Percentage of patients|||Number
120187|NCT00642278|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12|The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||mmol/L||Standard Deviation|Mean
120188|NCT00642278|Primary|Change in HbA1c From Baseline to Week 12|The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.|Day 1 (Baseline) and Week 12|This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when Week 12 values were missing. The table includes only patients with both baseline and post baseline values.||Percent||Standard Deviation|Mean
120189|NCT00642174|Secondary|Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate|Thromboelastography (TEG) platelet mapping (MP) maximum amplitude (MA) – Adenosine Diphosphate (ADP) millimeters (mm) at each time point. The TEG-MP MA measures strength of clot formation in whole blood. MA-ADP is the maximal amplitude resulting from fibrin and platelets not blocked by ADP-receptor inhibiting drugs. Fibrin strands in blood sample link a rotating sample cup with a stationary pin suspended by a torsion wire. The degree of platelet contribution to the MA through platelet-fibrin bonding directly influences the magnitude of pin movement and ultimately the amplitude of the tracing.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Inhibition of Platelet Function (IPF) as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP), who met compliance criteria, and who had last dose of study drug prior to blood draw for IPF.||millimeters (mm)||95% Confidence Interval|Least Squares Mean
120190|NCT00642174|Secondary|Platelet Reactivity Index (PRI)|Data from the Vasodilator-associated stimulated phosphoprotein assay were reported as the platelet reactivity index (PRI) which was calculated from corrected mean fluorescence intensity (cMFI) following incubation of platelets with either prostaglandin E1 (PGE1) alone or PGE1 plus ADP: Platelet Reactivity Index (%) = [1-(cMFI PGEI+ADP/cMFI PGEI)] x 100. Lower PRI values indicate greater platelet P2Y12 inhibition.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for Vasodilator-Associated Stimulated Phosphoprotein (VASP), who met compliance criteria, and who had last dose of study drug prior to the blood draw for inhibition of platelet function as assessed by VASP.||percent inhibition||95% Confidence Interval|Least Squares Mean
120278|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to methyldibromo-glutaronitrile||percentage of concordant responses||95% Confidence Interval|Number
120191|NCT00642174|Secondary|Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)|Mean platelet aggregation (MPA) to 5 and 20 µM adenosine diphosphate (ADP) was assessed by light transmittance aggregometry (LTA). Platelet aggregation was monitored for a total of 7 minutes after addition of ADP. Maximum platelet aggregation was the maximal aggregation value achieved during the 7-minute observation period following addition of agonists.|Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for MPA.||percent platelet aggregation||95% Confidence Interval|Least Squares Mean
120192|NCT00642174|Secondary|Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay|Inhibition of platelet aggregation 1- and 24-hours after loading dose and 24-hours after last maintenance dose was administered was assessed using Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from PRU (rate and extent of ADP-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD)|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.||percent inhibition||95% Confidence Interval|Least Squares Mean
120193|NCT00642174|Primary|Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay|The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate [ADP]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition [reference values]: rate and extent of Thrombin Receptor-Activated Peptide-stimulated platelet aggregation) values as follows: Percentage (%) inhibition = (1-PRU/BASE) x 100.|4 hours after loading dose|Pharmacodynamic Population, which included all randomized participants who had blood draws for IPA at 4 hours, who met compliance criteria, and who had last dose of study drug prior to the blood draw for IPA.||percent inhibition||95% Confidence Interval|Least Squares Mean
120194|NCT00641862|Secondary|Childhood Neurodevelopment/Neurocognitive Function|Neurodevelopmental status and neurocognitive function are measured by measured by the cognitive scale of the Bayley scales of infant development, 3rd edition|18 and 30 months||||||
120195|NCT00641862|Secondary|Changes in Maternal Hemoglobin Levels, Maternal Weight Gain and Infant Birth-weight.||Maternal hemoglobin levels will be assessed at weeks 24 and 34 pre-pregnancy and at 6 weeks post-partum. Maternal weight gain will be assessed monthly until delivery and at 6 weeks post-partum. Infant birth-weight will be assessed at birth.||||||
120196|NCT00641862|Primary|Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester||from 1st to 3rd trimester|||pmol/L||Inter-Quartile Range|Median
120197|NCT00640835|Primary|Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity|Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.||Participants|||Number
120198|NCT00640835|Primary|Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.|"Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:~Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs"|12 weeks|The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.||Participants|||Number
120199|NCT00641745|Primary|Number of Participants With Adverse Events.||12 months|||participants|||Number
120200|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
120201|NCT00641719|Secondary|Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint|A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
120202|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
125631|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hepato-/Gastrointestinal’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
120203|NCT00641719|Secondary|Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint|Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
120204|NCT00641719|Secondary|Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
120205|NCT00641719|Secondary|Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
120206|NCT00641719|Secondary|Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, 1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
120207|NCT00641719|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|1 year|Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.||units on a scale||Standard Deviation|Mean
120208|NCT00641719|Primary|Number of Participants Who Experienced an Adverse Event (AE)|See the Reported Adverse Events section for details.|baseline through 1 year|All participants who received at least 1 dose of study drug.||participants|||Number
120209|NCT00641706|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Confirmed Response (CR), Partial Response (PR), or Regression (REGR) on Two Consecutive Evaluations|"Confidence intervals for the true proportion will be calculated using the exact binomial method.~Measurable patients must achieve at least a 50% reduction in the product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Evaluable patients must achieve unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|Arm A patients that started treatment. Arm B patients were not analyzed for this outcome because they received surgery and hence response was not measured.||proportion of patients||95% Confidence Interval|Number
120210|NCT00641706|Secondary|Time to Progression|Estimated using Kaplan-Meier survival curve. Patients who died were considered to have disease progression at the time of death unless there was documented evidence that no progression occurred before death. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|From study registration to date of progression (up to 5 years)|Patients that started treatment.||months||Full Range|Median
120211|NCT00641706|Secondary|Overall Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Patients that started treatment.||months||Full Range|Median
120212|NCT00641706|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months. For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions. For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.|At 6 months|Patients that started treatment.||percentage of patients|||Number
120213|NCT00641667|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale|The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.|Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.||Participants|||Number
120214|NCT00641667|Secondary|Mean Number of Rescue Doses|Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Rescue Doses||Standard Deviation|Mean
120215|NCT00641667|Secondary|Number of Participants With Total Duration of Pain Per Day|The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
120216|NCT00641667|Secondary|Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain|Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
120217|NCT00641667|Secondary|Pain Intensity Visual Analog Scale (VAS) Score|Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain conceivable”.|Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||mm||Standard Deviation|Mean
120218|NCT00641667|Secondary|Number of Participants With Response Based on Patient’s Global Assessment Scale|Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.|Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED|The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.||Participants|||Number
120219|NCT00641667|Primary|Percentage of Participants Achieving Pain Control|Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.|Day 10 or early discontinuation (ED)|Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.||Percentage of Participants||95% Confidence Interval|Number
120220|NCT00641641|Primary|Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)|change was calculated as the mean of 12 assessments minus the baseline value|12 times within 48 weeks.|Intention to treat||log copies/mL plasma||Standard Deviation|Mean
120221|NCT00641563|Secondary|BIS-Index Awake and 3 Sedation Levels (RS 2/3/4)|BIS-Index is a dimensionless value ranging from 0-100, indicating fully awake at 100 and a flat-line electroencephalogram at 0. Standard anesthesia creates a BIS-Index range 40-60. The scale is ordinal, not interval. BIS Index is calculated from the EEG by a proprietary algorithm (Aspect Medical Inc.)|awake and 3 sedation levels (RS 2/3/4) 20 min each|||Units on a scale||Standard Deviation|Mean
120222|NCT00641563|Primary|Amplitudes (in Micro Volts) of Acoustic Event Related Potentials (Time-locked Amplitudes in the Electroencephalogram 100 Milliseconds After the Acoustic Stimulus, Averaged Over 40 Stimuli)Awake and at 3 Different Drug-induced Sedation Levels|Event Related Potentials (time-locked amplitudes in the electroencephalogram 100 milliseconds after the acoustic stimulus, averaged over 40 stimuli) Sedation levels were graded with the Ramsay scale (RS), where the responses of patients to standardized increasing stimuli (voice, then prodding, the pain stimulus) are graded. The higher the number, the deeper is the sedation. RS 6 means no response at all (= anesthesia)|awake + 3 sedation levels (RS2/3/4) (20 minutes each)|||micro Volt||Standard Deviation|Mean
120223|NCT00641537|Primary|Number of Participants Who Developed Herpes Zoster Infections and Malignancies|Herpes zoster infection is defined as having at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms herpes zoster, herpes zoster iridocyclitis, herpes zoster ophthalmic, herpes zoster multi-dermatomal, herpes zoster infection neurological, herpes zoster oticus. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre_specified grouping Malignant and unspecified tumors.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.||Participants|||Number
120224|NCT00641537|Primary|Median Time to Recovery From Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1 during the CLARITY Extension Study.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. 'N' signifies number of participants who were evaluable for this outcome measure.||days||Full Range|Median
120225|NCT00641537|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.||participants|||Number
120226|NCT00641537|Secondary|Time to Disability Progression (Confirmed After 3 Months)|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. As few participants have reached EDSS progression, fourth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|ITT population included all participants who were randomized in the study.||months|||Number
120227|NCT00641537|Secondary|Mean Number of Combined Unique (CU) Lesions|Mean Number of CU lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|ITT population included all participants who were randomized in the study.||lesions||Standard Deviation|Mean
120228|NCT00641537|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|Intention-to-treat (ITT) population included all participants who were randomized in the study.||relapses per year||95% Confidence Interval|Number
120229|NCT00641537|Primary|Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Lymphocyte Toxicity|Lymphocyte toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grade for absolute lymphocyte counts included: Grade 1 = less than lower limit of normal; Grade 2 = less than 800 per cubic millimeter (/mm^3); Grade 3 = less than 500/mm^3; Grade 4 = less than 200/mm^3.|Baseline up to Week 120|Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.||percentage of participants|||Number
120230|NCT00641056|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.|Baseline to Week 26|ITT Population.||rate per subject-year||Standard Error|Mean
120231|NCT00641056|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmHg||Standard Deviation|Mean
120232|NCT00641056|Secondary|Ratio of Triglycerides at Week 26 to Baseline|Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||ratio||Standard Error|Least Squares Mean
120233|NCT00641056|Secondary|Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26|Change in HDL (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
120234|NCT00641056|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in Total Cholesterol (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
120235|NCT00641056|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW (kg) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||kg||Standard Error|Least Squares Mean
120236|NCT00641056|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG (mmol/L) from Baseline to Week 26|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||mmol/L||Standard Error|Least Squares Mean
120237|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 6.5% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
120238|NCT00641056|Secondary|Percentage of Patients Achieving HbA1c <=7.0% at Week 26|Percentage of patients achieving HbA1c <=7.0% at Week 26 (for patients with HbA1c >7% at baseline)|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > 7% were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of patients|||Number
120239|NCT00641056|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to Week 26|Baseline, Week 26|ITT Population: All randomized patients who had taken at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.||percentage of total hemoglobin||Standard Error|Least Squares Mean
120279|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to hydrocortizone-17-butyrate||percentage of concordant responses||95% Confidence Interval|Number
120240|NCT00641043|Secondary|Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
120241|NCT00641043|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
120242|NCT00641043|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
120243|NCT00641043|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
120244|NCT00641043|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and Week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
120245|NCT00641043|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetes medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
120246|NCT00641043|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
120247|NCT00641043|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
120248|NCT00641043|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
120249|NCT00641043|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
120250|NCT00641043|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
120251|NCT00641043|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all randomised and treated patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
120252|NCT00641043|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
120253|NCT00640978|Primary|Number of Participants Surviving at 6 Months|Overall survival (OS) at 6 months in participants receiving a combination of Erlotinib and RAD001 who have received previous treatment for advanced pancreatic cancer. OS at 6 months is number of participants alive at 6 months.|6 months|||Participants|||Number
120280|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen|Visit 5: 21 days after patch application|Subjects with past positive patch test results to gold sodium thiosulfate||percentage of concordant responses||95% Confidence Interval|Number
120388|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted FEV1||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120254|NCT00640926|Other Pre-specified|Per Patient Microbiological Response of Eradicated in the Microbiologically Evaluable (ME) Population at Test of Cure (TOC)|The number of ME patients (defined as those CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila) with a microbiologic response of eradicated, i.e. either documented eradication of the baseline pathogen(s), or presumed eradication in the setting of clinical cure with no material to culture.|Study Days 14-38|Microbiologically evaluable (ME) patients were defined as CE patients with evidence of 1 or more of 7 key CAP pathogens: S. pneumoniae, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, and L. pneumophila.||Participants|||Number
120255|NCT00640926|Primary|Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)|Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.|Study days 14-38|Clinically evaluable patients were those that had a diagnosis of CAP, as defined in the inclusion criteria; who received an appropriate course of therapy; who did not receive any other concomitant antibiotics, and who returned for a TOC visit in the appropriate time frame.||Participants|||Number
120256|NCT00640822|Secondary|Patients With Rebound During the Study||Week 8-16||||||
120257|NCT00640822|Secondary|Patients With Relapse During the Study and Time to Relapse||Week 8-16||||||
120258|NCT00640822|Secondary|Total Sign Score of the Intertriginous Areas||Week 8||||||
120259|NCT00640822|Secondary|Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment||Week 8||||||
120260|NCT00640822|Secondary|Severity Scores for Redness, Thickness and Scaliness of the Face||Week 8||||||
120261|NCT00640822|Secondary|Total Sign Score of the Face||Week 8||||||
120262|NCT00640822|Secondary|Overall Disease Severity of the Face According to the Investigator's Assessment||Week 4||||||
120263|NCT00640822|Primary|Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8||Week 8|||Participants|||Number
120264|NCT00640614|Secondary|Persistent Reactions: All T.R.U.E. Test Allergens|Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)|initially occur 2-4 days after application and last through 7-21days after patch application|||participants|||Number
120265|NCT00640614|Secondary|Late Reactions: All T.R.U.E. Test Allergens|Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).|7-10 days after patch application|||participants|||Number
120266|NCT00640614|Secondary|Safety Evaluations: All T.R.U.E. Test Allergens|Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.|Day 2: 48 hours after application|NOTE: These secondary measurements apply to the entire subject population and were not separated by 'sensitive' or 'consecutive' subjects.||participants|||Number
120267|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bronopol|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
120268|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Disperse Blue|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
120269|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Parthenolide|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
120270|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Bacitracin|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
120271|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
120272|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate|The number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
120273|NCT00640614|Primary|Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate|Number of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen|Visit 5: 21 days after patch application|||percentage of agreement||95% Confidence Interval|Number
120274|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive test results to bronopol||percentage of concordant responses||95% Confidence Interval|Number
120275|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance:Number of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to disperse blue||percentage of concordant responses||95% Confidence Interval|Number
120276|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to parthenolide||percentage of concordant responses||95% Confidence Interval|Number
120277|NCT00640614|Primary|Diagnostic Performance: Concordance|Concordance: Number of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.|Visit 5: 21 days after patch application|Subjects with past positive patch test results to bacitracin||percentage of concordant responses||95% Confidence Interval|Number
125632|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Musculoskeletal’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
120281|NCT00640601|Secondary|Change in Barnes Akathisia Rating Scale (BARS)|The Percentage of patients with change in BARS score was calculated. The BARS is a 4 item scale that is rating Extrapyramidal symptoms (EPS) on a 4-point scale for the first three questions and on a 6-point scale for the last question. 0=normal and a higher value represents more pronounced symptoms of EPS. BARS has a focus on the akathisia symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||percentage of subjects|||Number
120282|NCT00640601|Secondary|Change in Safety Measure: Simpson-Angus Scale (SAS)|The Percentage of patients with change in Simpson-Angus Scale (SAS)was calculated. This is a 10 item scale that is rated on a five-point scale where 0=normal and 4=severe symptoms of Extrapyramidal symptoms (EPS) with a focus on parkinsonian symptoms of EPS.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||Percentage of subjects|||Number
120283|NCT00640601|Secondary|Change in Social and Occupational Functioning Assessment Scale (SOFAS)|Change in SOFAS score. The SOFAS is a 100 point single item scale that rates functioning of a patient. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120284|NCT00640601|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|Change in CGI-I scale. This scale is the second part of the CGI scale that is scored at Visit 3 to week 24 to observe the patient’s change from start of treatment. The scores for the CGI-I subset ranges from 1 to 7 (1=very much improved, 7=very much worse and a score of 4 indicates no change.)|Day 7 - week 24|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120285|NCT00640601|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S assesses severity of illness which is scored to rate the patient’s current clinical state at start of treatment. The scores range from 1 to 7, where 1= normal, not at all ill, while a score of 7=among the most extremely ill of subjects. The change from start of treatment in the severity of illness is calculated by subtracting the score at start of treatment from the visit score. Alleviation of symptom severity will be indicated by a negative change score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120286|NCT00640601|Secondary|Change in Global Assessment Scale (GAS)|Change in GAS score. The GAS is a 100-point single item scale that rates patient’s functioning on a hypothetical continuum of mental health to mental illness. The scale values range from 1 to 100 (1=most impaired, 100=healthiest).|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120287|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score|Change in negative subscale of PANSS. This subscale calculates the sum of the scores in PANSS items N1-N7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120288|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score|Change in positive subscale of PANSS. This subscale calculates the sum of the scores in PANSS items P1-P7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120289|NCT00640601|Secondary|Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score|Change in PANSS total score which includes Positive, Negative and General psychopathology. The PANSS is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7, where 1=absent, 7=extreme). Maximum total score: 210, minimum total score is 30. Seven items are referring to positive symptoms (P1-7), seven items to negative symptoms (N1-7) and 16 items to general psychopathology (G1-16). The assessment prior to start of treatment is considered the baseline assessment.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120290|NCT00640601|Secondary|Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score|Numerical change in CGI-CB score. The CGI-CB scale is used to evaluate investigator’s global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||units on a scale||Standard Deviation|Mean
120291|NCT00640601|Primary|Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study|Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator’s global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.|Baseline to 24 weeks (or end of study)|The intention to treat (ITT) population (i.e., all subjects who received at least one dose of the study medication) comprised the population for the analysis (n=295)||Percentage of Participants||95% Confidence Interval|Mean
120292|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration|Change of drug use from baseline to last visi|||Participants|||Number
120293|NCT00640562|Secondary|Body Mass Index (BMI) at Week 12|Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.|12 week|||Kg/m^2||Standard Deviation|Mean
120294|NCT00640562|Secondary|Change From Screening Visit to Week 12 of Prolactin Live|Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit|12 week from screening visit to last visit|||KG||Standard Deviation|Least Squares Mean
120295|NCT00640562|Secondary|Concomitant Use of Antidepressive Drugs From Baseline to Week 12|Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration|12 week from baseline to last visi|||Participants|||Number
120296|NCT00640562|Secondary|Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section|"Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.~The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40~Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments."|12 weeks from baseline to last visit|||score on scale||Standard Deviation|Mean
120297|NCT00640562|Secondary|Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score|These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or –1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response|12 week from baseline to last visit|||score on scale||Standard Deviation|Least Squares Mean
120298|NCT00640562|Secondary|CGI- Global Improvement Mean Score at Week 12|The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates “normal, not at all ill”, while a score of 7 indicates “among the most extremely ill of patients”. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits|12week: descriptive statistic of CGI by visit and treatment|||score on a scale||Standard Deviation|Mean
120299|NCT00640562|Secondary|- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score|The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates “normal, not at all ill”, while a score of 7 indicates “among the most extremely ill of patients”. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits|12 weeks from baseline to last visit|||Score on scale||Standard Deviation|Least Squares Mean
120300|NCT00640562|Secondary|Change From Baseline to Week 12 of PANSS Score|30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.|12 weeks from baseline to last visit|||score on scale||Standard Deviation|Mean
120301|NCT00640562|Secondary|Change From Baseline to Week 12 of HAM-D Score|21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.|12 weeks from baseline to last visit|||Score on scale||Standard Deviation|Mean
120302|NCT00640562|Primary|Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.|"The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.~CDSS has 9 items rated on four–point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients’ responses to questions; the 9 item is based on clinician’s assessment.~The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression."|12 week from baseline to last visit|||Score on a scale||Standard Deviation|Least Squares Mean
120303|NCT00640510|Secondary|Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|30 min, 60 min, 90 min and 2 hours post first IM injection|Number of patients having the measure at post-baseline. Last Observation Carried Forward.||participants|||Number
120304|NCT00640510|Secondary|Number of Responders at 2 Hours After First Intramuscular (IM) Injection|A responder was defined ast he patient with ≥ 40% decrease in the PANSS-EC total score at 2 hours after the first IM injection in comparison with baseline. (See outcome measure 1 for description of PANSS-EC).|2 hours post first IM injection|Number of patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.||participants|||Number
120305|NCT00640510|Secondary|Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|15 min, 30 min, 60 min, 90 min post first IM injection|Number of patients having the measure both at baseline and post-baseline. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
120373|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Lung Capacity at the Time When the DLCO is Measured (Alveolar Volume, VA)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120306|NCT00640510|Primary|Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|2 hours post first intramuscular (IM) injection|Number of randomized patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
120307|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - PP|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.~Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.~Scale is from 0 best to 30 worst.~0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140. Results for one were excluded because of missing DLQI questionnaire results.||Units on a scale||Standard Deviation|Mean
120308|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - PP|"BSA scores are evaluated at each time point.~BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140.||Percent of body affected||Standard Deviation|Mean
120309|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - PP|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).~PGA scores are evaluated at each time point.~The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:~0 = clear~1 = minimal~2 = mild~3 = moderate~4 = severe~5 = very severe~The scale evaluates plaque elevation, scaling and erythema."|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol. And PGA was not performed for another patient (Day 168)||Participants|||Number
120310|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.||Participants|||Number
120311|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reductionin PASI From Baseline (PASI-75) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.||Participants|||Number
120312|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - PP|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|84, 112, 140 and 168 days|The analysis was per protocol (PP). Participants that were not 80 percent compliant to narrow band UVB treatment at each visit and patients that missed excessive etanercept injections were excluded completely from analysis. One patient missed a visit at Day 140 but was compliant to protocol.||Participants|||Number
120313|NCT00640393|Secondary|Number of Serious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of serious adverse events.~Definition: any adverse event from this study that results in one of the following outcomes, or is significant for any other reason:~death~initial or prolonged inpatient hospitalization~a life-threatening experience (that is, immediate risk of dying)~persistent or significant disability/incapacity~congenital anomaly/birth defect"|196 days|The analysis was intention to treat (ITT).||Serious adverse events|||Number
120314|NCT00640393|Secondary|Number of Infectious Adverse Events - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of infectious adverse events.~Definition: An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.~Only infectious and malignant (including any type of skin cancer) adverse events were recorded."|196 days|The analysis was intention to treat (ITT).||Infectious adverse events|||Number
120374|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120315|NCT00640393|Secondary|Number of Adverse Drug Reactions - ITT|"Evaluation of safety of etanercept and nbUVB as compared to etanercept alone by reporting the incidence rates of adverse drug reactions.~Definition: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.~Only adverse drug reactions that were at least possibly related to etanercept were recorded. All symptoms observed at the injection site such as erythema, burning, edema and pruritus were recorded together as Injection Site Reaction."|196 days|The analysis was intention to treat (ITT).||Adverse drug reactions.|||Number
120316|NCT00640393|Secondary|Dermatology Life Quality Index (DLQI) - ITT|"The aim of this questionnaire is to measure how much one's skin problem has affected one's life over the week prior to the visit.~Questionnaire is patient-assessed (self-reported). DLQI scores are evaluated at each time point.~Scale is from 0 best to 30 worst.~0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life"|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
120317|NCT00640393|Secondary|Body Surface Area (BSA) Affected by Psoriasis - ITT|"BSA scores are evaluated at each time point.~BSA is a measure of the percentage of body surface affected by psoriasis."|0, 84, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Last Observation Carried Forward (LOCF).||Percent of body affected||Standard Deviation|Mean
120318|NCT00640393|Secondary|Number of Patients Attaining a PGA (Physician's Global Assessment) of 0 or 1 - ITT|"Number of patients attaining a Physician's Global Assessment (PGA) of clear (0) or minimal (1).~PGA scores are evaluated at each time point.~The degree of overall lesion severity at the time of the physician's evaluation of the patient evaluated using the following scale:~0 = clear~1 = minimal~2 = mild~3 = moderate~4 = severe~5 = very severe~The scale evaluates plaque elevation, scaling and erythema."|0, 112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non Responder (NRI).||Participants|||Number
120319|NCT00640393|Secondary|Number of Participants Attaining a 100 Percent Reduction in PASI From Baseline (PASI-100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
120320|NCT00640393|Secondary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI-90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
120321|NCT00640393|Secondary|Number of Participants Attaining a 75 % Reduction in PASI From Baseline (PASI-75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
120322|NCT00640393|Secondary|Number of Participants Attaining a 50% Reduction From Baseline in PASI From Baseline (PASI-50) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|28 and 84 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
120323|NCT00640393|Secondary|Number of Participants Attaining a 100% Reduction in PASI From Baseline (PASI 100) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder (NRI).||Participants|||Number
120324|NCT00640393|Secondary|Number of Participants Attaining a 75 Percent Reduction in PASI From Baseline (PASI 75) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112, 140 and 168 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).||Participants|||Number
120375|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Percent of Predicted VC||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120376|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Vital Capacity (VC)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120325|NCT00640393|Primary|Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT|"Four anatomic sites - head, upper extremities, trunk and lower extremities - are assessed for erythema, induration, and desquamation. The severity of each sign is assessed using a 5-point scale:~0 = No symptoms~1 = Slight~2 = Moderate~3 = Marked~4 = Very marked~The area affected by psoriasis within a given anatomic site is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of psoriatic involvement from 0-6.~Total scale 0 = best and 72 = worst"|112 and 140 days|The analysis was intention to treat (ITT) and the imputation technique was Non-Responder(NRI).||Participants|||Number
120326|NCT00640341|Primary|Uncorrected Distance High Contrast Visual Acuity|logMAR high contrast visual acuity (VA) over all visits.|Over all visits for the 1 month study period|All eligible dispensed eyes.||LogMAR|Participants|Standard Deviation|Mean
120327|NCT00640341|Primary|Subjective Responses to Comfort-related Symptoms/Complaints|Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.|Over all follow-up visits for 1 month study period|All eligible dispensed eyes.||Units on a Scale|Participants|Standard Deviation|Mean
120328|NCT00640341|Primary|Any Slit Lamp Finding > Grade 2|All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.|Over all follow-up visits for the 1 month study period|All dispensed eyes||Eyes|Participants||Number
120329|NCT00640328|Secondary|Half Life (t1/2) of Ofatumumab in the Terminal Elimination Phase Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for half life. Half life is defined as the period of time required for the amount of drug in the body to be reduced by half. The average t1/2 over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."||hours||Geometric Coefficient of Variation|Geometric Mean
120330|NCT00640328|Secondary|The Volume of Distribution at Steady State (Vss) of Ofatumumab Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for Vss. The average Vss over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants who contributed data at the indicated time points were analyzed (reflected by n= in the category titles)."||liters||Geometric Coefficient of Variation|Geometric Mean
120331|NCT00640328|Secondary|Clearance of Ofa Over the Course of Weeks 0-2 and 24-26|The peripheral blood for each participant was collected and analyzed for clearance. Clearance is the measure of efficiency with which a drug is irreversibly removed form the body. The average clearance over the course of Weeks 0-2 and 24-26 is reported.|Weeks 0-2 and 24-26|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||liters per hour||Geometric Coefficient of Variation|Geometric Mean
120332|NCT00640328|Secondary|Time to Reach Cmax (Tmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for tmax.|Visit 3 (Week 0), Visit 4 (Week 2),Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||hours||Full Range|Median
120333|NCT00640328|Secondary|The Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point (AUC(0-t)) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed to estimate the area under the plasma concetration-time curve, AUC(0-t), and was assessed using the non-compartmental method.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour (hr) after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Millgram hour per liter||Geometric Coefficient of Variation|Geometric Mean
120334|NCT00640328|Secondary|The Maximum Observed Plasma Concentration (Cmax) After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) i.v. Infusions|The peripheral blood for each participant was collected and analyzed for Cmax after the first, second, third, and fourth i.v. infusions. Assessment was performed using the noncompartmental method (this analysis is highly dependent on the estimation of total drug exposure).|Visit 3 (Week 0), Visit 4, (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||milligrams per liter||Geometric Coefficient of Variation|Geometric Mean
120335|NCT00640328|Secondary|Ofa Drug Concentration After the First (Visit 3), Second (Visit 4), Third (Visit 10), and Fourth (Visit 11) Intravenous (i.v.) Infusions|The peripheral blood for each participant was collected and analyzed for the concentration of the drug in serum. There were four infusions in the study; the third infusion at Visit 10 represents the first infusion of the second treatment period (Weeks 24-48). Data are presented for the predose concentrations.|Visit 3 (Week 0), Visit 4 (Week 2), Visit 10 (Week 24), and Visit 11 (Week 26). Samples were drawn predose, immediately following the end of infusion, 10 minutes after infusion, 1 hour after infusion, and 2 hours after infusion.|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||milligrams per liter||Standard Deviation|Mean
120336|NCT00640328|Secondary|Total Volume of T2 Lesions at Week 24 and Week 48|The MRI scan should be performed prior to dosing and can be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. The volume of T2 lesions was not a cumulative volume, but the volume measured at Visit 10 and Visit 17. T2 lesion measurements measure all lesions on the brain in terms of volume and size, measuring for new lesions or enlarging lesions.|Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||millimeters cubed||Standard Deviation|Mean
120337|NCT00640328|Secondary|Number of the Indicated Types of Lesions (Ls) Assessed Per Magnetic Resonance Imaging (MRI)|"The MRI scan was performed prior to dosing and could be performed up to 4 days prior to Visits 3 and 10. An IDMC reviewed the data. T1 enhancing Ls are enhanced by gadolinium, are considered representative of disease activity/inflammation, and may signify a relapse. Measurement of these Ls is comparative from visit to visit. Total T1 enhancing Ls represent the total of the new T1 enhancing Ls over the entire study period. T2 L measurements measure all Ls on the brain in terms of volume and size, measuring for new or enlarging Ls. T1 hypointensive Ls are areas of permanent damage."|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||lesions||Standard Deviation|Mean
120338|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Complement Activation (CH50) at Week 24 (FTP) and Week 48 (STP)|Blood samples of participants were collected for CH50 prior to and 2 hours after dosing, and the samples were sent to a Central Laboratory for analysis: Bio Analytical Research Corporation (BARC). Change from Baseline (Week 0 for the FTP; Week 24 for the STP) was calculated as the value at Weeks 24 (FTP) and 48 (STP) minus the value at Baseline. Ofa depletes (induces the cell death of) B cells. When Ofa binds to a B cell, it induces complement CH50, which in turn causes cell death via cytotoxicity. Therefore, the CH50 levels were measured to ensure that CH50 was being appropriately activated.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Units per milliliter||Standard Deviation|Mean
120339|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Temperature at Week 24 (FTP) and Week 48 (STP)|The temperature of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Degrees Celsius||Standard Deviation|Mean
120340|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Pulse Rate at Week 24 (FTP) and Week 48 (STP)|The pulse rate of each participant was assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||beats per minute||Standard Deviation|Mean
120341|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP and Week 24 for the STP) in Blood Pressure (BP) at Week 24 (FTP) and Week 48 (STP)|Maximum (systolic) and minimum (diastolic) BP were assessed prior to infusion. Change from Baseline (Week 0 for the FTP and Week 24 for the STP) was calculated as the value at Visit 10 (Week 24) for the FTP and the value at Visit 17 (Week 48) for the STP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||millimeters of mercury||Standard Deviation|Mean
120342|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Immunoglobins at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of antibodies produced by B-cells (immunoglobins): immunoglobulin A, immunoglobin G, and immunoglobin M. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||grams per liter||Standard Deviation|Mean
120343|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP,Week 24 for the STP, and Week 0 for the IFUP) in Bilirubin and Creatinine at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bilirubin and creatinine. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Micromoles per liter (µmol/L)||Standard Deviation|Mean
120344|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Bicarbonate, Glucose, Potassium, Sodium, and Urea at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of bicarbonate, glucose, potassium, and urea. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||millimoles per liter||Standard Deviation|Mean
120345|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Alkaline Phosphatase, Aspartate Aminotransferase (AST), and Alanine Transaminase (ALT) at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for the assessment of alkaline phosphatase, AST, and ALT. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Units per liter||Standard Deviation|Mean
120346|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Albumin at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of albumin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 104 for the IFUP) in albumin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: VIsit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||grams per liter||Standard Deviation|Mean
120347|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hemoglobin Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of hemoglobin count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hemoglobin was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Millimoles/liter||Standard Deviation|Mean
120348|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Hematocrit at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematocrit assessment. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs). Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in hematocrit was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline. Hematocrit is measured as a percentage, i.e., volume (V) of red blood cells per volume of blood.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Percentage of BV occupied by RBCs||Standard Deviation|Mean
120349|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Erythrocyte Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for assessment of erythrocyte count. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in erythrocyte count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Visit 26 (Week 104) for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Pico (10^12) per liter||Standard Deviation|Mean
120350|NCT00640328|Primary|Change From Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelet Count at Week 24 (FTP), Week 48 (STP), and Week 104 (IFUP)|Blood samples of participants were collected for hematology assessment. Change from Baseline (Week 0 for the FTP, Week 24 for the STP, and Week 0 for the IFUP) in basophils, eosinophils, leukocytes, monocytes, lymphocytes, neutrophils, and platelets count was calculated as the value at Visit 10 (Week 24) for the FTP, the value at Visit 17 (Week 48) for the STP, and the value at Week 104 for the IFUP minus the value at Baseline.|FTP: Visit 3 (Week 0) and Visit 10 (Week 24); STP: Visit 10 (Week 24) and Visit 17 (Week 48); IFUP: Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||Giga (10^9) per liter||Standard Deviation|Mean
120351|NCT00640328|Primary|Number of Participants With Abnormal Physical Examination Findings|The investigator performed the physical examination, which included but was not limited to: general appearance and the following body systems: lymph nodes, mouth and throat, lungs, cardiovascular, abdomen, extremities, muscular-skeletal, neurological (apart from multiple sclerosis [a brain and spinal cord disease]), and skin. All abnormal clinically relevant findings such as vein problems (venous varices), disorder of the vertebral column (vertebropathy), increased hearing loss, post operative mark (scar), and chronic skin disorder with no sweat and itching (anhidrotic eczema) were reported.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS||participants|||Number
120352|NCT00640328|Primary|Number of Participants With Negative or Unconfirmed Human Anti-human Antibodies (HAHA) in Which Concentrations of Ofa Were Below 500 Nanograms Per Milliliter (ng/ml)|Participants are checked for negative (or a lack of) HAHA at Baseline, and then throughout the study, to ensure that the investigational product is not causing HAHA development. Participants with concentrations of Ofa that are missing or are above 500 nanograms per milliliter (ng/mL) are considered to have unconfirmed HAHA results.|Visit 3 (Week 0), Visit 10 (Week 24), Visit 17 (Week 48) or early withdrawal (EW), and Visit 26 (Week 104)|"FAS. Only those participants contributing data at the indicated time points were analyzed (reflected by n= in the category titles)."||participants|||Number
120353|NCT00640328|Primary|Number of Participants With the Indicated Critical Adverse Events (CAEs)|A CAE=treatment-related (TR) grade (G) >=3 AE on day of infusion (inf.) preventing inf. to be resumed, a TR G 3 bronchospasm during 1 inf., an AE whose severity becomes G 3 for the third time during 1 inf., infections reported as serious, a TR neurological event consistent with progressive multifocal leukoencephalopathy (PML), any malignancy, and any fatal adverse drug reaction. AE severity (assessed as G 1-5) was classified using the Common Terminology Criteria for Adverse Events v3.0: G 1=mild AE; G 2=moderate AE; G 3=severe AE; G 4=life-threatening or disabling AE; G 5=death related to AE.|FTP: From Visit 3 (Week 0) up to Visit 10 (Week 24); STP: From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|FAS||participants|||Number
120377|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Total Airway Resistance (Raw)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120378|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Maximal Expiratory Flow at 25% of Expiratory Vital Capacity (MEF25)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120354|NCT00640328|Primary|Number of Participants With Any Adverse Event|"An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. Non-serious AEs were not collected during the Individualized Follow-up Period."|First Treatment Period (FTP): From Visit 3 (Week 0) up to Visit 10 (Week 24); Second Treatment Period (STP): From Visit 10 (Week 24) up to Visit 17 (Week 48); IFUP: up to Visit 26 (Week 104)|Full Analysis Set (FAS): all participants who had been exposed to the investigational product (IP) irrespective of their compliance to the planned course of treatment.||participants|||Number
120355|NCT00640315|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Day 3|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
120356|NCT00640315|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Day 3|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
120357|NCT00640315|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Day 3|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
120358|NCT00640315|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Day 3|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
120359|NCT00640315|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Day 3|PR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and day 3|All subjects who received at least one dose of the trial medication were included in the safety evaluation.||msec||Standard Deviation|Mean
120360|NCT00640315|Secondary|Area Under the Plasma Concentration Verse Time Curve From Zero to the Last Data Point (AUC0-tn) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
120361|NCT00640315|Secondary|Mean Residence Time (MRT) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||hour||Geometric Coefficient of Variation|Geometric Mean
120362|NCT00640315|Secondary|Half-life Associated With the Terminal Slope (t1/2) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||hour||Geometric Coefficient of Variation|Geometric Mean
120363|NCT00640315|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||hour||Full Range|Median
120364|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Intrapulmonary Shunt Flow||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage of total perfusion||Standard Deviation|Mean
120365|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/MIN||Standard Deviation|Mean
120366|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hours Post Dose of Ventilation-perfusion Distribution Presented as Standard Deviation (SD) of Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/MIN||Standard Deviation|Mean
120367|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Normal V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120368|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Low V/Q Perfusion||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120369|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Dead Space Ventilation||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage of total ventilation||Standard Deviation|Mean
120370|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Perfusion (Q)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/min||Standard Deviation|Mean
120371|NCT00640315|Secondary|Multiple Inert Gas Elimination Technique (MIGET) Analysis - Change From Baseline at 1 Hour Post Dose of Total Ventilation (V)||Baseline and 1 hour post dose|per-protocol population (subjects with data available for this outcome measure)||L/min||Standard Deviation|Mean
120372|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Specific Diffusing Capacity||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120389|NCT00640315|Secondary|Lung Function - Percentage Change From Baseline at 2 Hours Post Dose of Forced Expiratory Volume in 1 Second (FEV1)||Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120390|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Saturation (SvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120391|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Oxygen Saturation (SaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120392|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Venous Oxygen Pressure (PvO2)|"Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120393|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Pressure of Carbon Dioxide (PaCO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120394|NCT00640315|Secondary|Blood Gas Analysis - Percentage Change From Baseline at 2 Hours Post Dose of Arterial Partial Oxygen Pressure (PaO2)|"Arterial blood gas analysis was performed by insertion of an indwelling arterial cannula. Percent change was calculated as 100%*(value post dose - value at baseline)/ value at baseline."|Baseline and 2 hours post dose|per-protocol population (subjects with data available for this outcome measure)||Percentage||Standard Deviation|Mean
120395|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Index|Cardiac index was calculated as cardiac index = CO / body surface area.|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||L/min/m^2||Standard Deviation|Mean
120396|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance Index (SVRI)|SVRI was calculated as SVRI = (80*(MAP - RAPmean)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||dyn*s*cm^-5*m^2||Standard Deviation|Mean
120397|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systemic Vascular Resistance (SVR)|SVR was calculated as SVR = 80*(MAP-RAPmean)/CO|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||dyn*s*cm^-5||Standard Deviation|Mean
120398|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance Index (PVRI)|PVRI was calculated as PVRI = (80*(PAPmean - PCWP)/CO)*body surface area|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||dyn*s*cm^-5*m^2||Standard Deviation|Mean
120399|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Cardiac Output (CO)|CO was measured in triplicate by the thermodilution technique|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||L/min||Standard Deviation|Mean
120400|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Arterial Pressure (MAP)|MAP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
120401|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Blood Pressure (DBP)|Diastolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
120402|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Blood Pressure (SBP)|Systolic arterial blood pressure was acquired during right heart catheterization.|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
120403|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Heart Rate (HR)|HR was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||beats per minute||Standard Deviation|Mean
120404|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Capillary Wedge Pressure (PCWP)|PCWP was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||mmHg||Standard Deviation|Mean
120405|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Diastolic Pulmonary Artery Pressure (PAPdiast)|PAPdiast was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
120406|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Systolic Pulmonary Artery Pressure (PAPsyst)|PAPsyst was acquired during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||mmHg||Standard Deviation|Mean
120407|NCT00640315|Secondary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Right Atrial Pressure (RAPmean)|RAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||mmHg||Standard Deviation|Mean
120408|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||kg/L||Geometric Coefficient of Variation|Geometric Mean
120409|NCT00640315|Primary|Maximum Drug Concentration in Plasma Divided by Dose (Cmax/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||10^3/L||Geometric Coefficient of Variation|Geometric Mean
125633|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Pulmonary’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
120411|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose Per kg Body Weight (AUCnorm) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||kg*h/L||Geometric Coefficient of Variation|Geometric Mean
120412|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||10^3*h/L||Geometric Coefficient of Variation|Geometric Mean
120413|NCT00640315|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of Riociguat and Metabolite M1 After Single Dose of Riociguat||Study day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 36 hours post-dose; Study day 3: 0, 2, 6, 12, 24 hours post-dose|per-protocol population||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
120414|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Pulmonary Vascular Resistance (PVR)|PVR was calculated according to the formula PVR = 80*(PAPmean - pulmonary capillary wedge pressure)/cardiac output|From baseline up to 4 hours after administration|per-protocol population (subjects with data available for this outcome measure)||(dyn*s*cm^-5)||Standard Deviation|Mean
120415|NCT00640315|Primary|Swan-Ganz Hemodynamics - Maximal Change From Baseline at Day 1 of Mean Pulmonary Artery Pressure (PAPmean)|PAPmean was reported during right heart catheterization|From baseline up to 4 hours after administration|per-protocol population||mmHg||Standard Deviation|Mean
120416|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|6 months post study|Number of investigators providing 6-month post study survey response (n=169); surveys were completed one per investigator.||investigators|||Number
120417|NCT00640042|Secondary|Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.|The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.|3 months post study|Number of investigators providing 3-month post study survey response (n=219); surveys were completed one per investigator.||investigators|||Number
120418|NCT00640042|Secondary|Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.|After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.|Up to 4 months|Number of subjects with risk level assessment at Visit 4 (Week 10)||cases|||Number
120419|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)|Risk level was determined by the investigator using the subject’s SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 4 (Week 10)|Number of subjects with risk level assessment at Visit 4 (Week 10)||participants|||Number
120420|NCT00640042|Primary|Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)|Risk level was determined by the investigator using the subject’s SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.|Visit 3 (Week 6)|Number of subjects with risk level assessment at Visit 3 (Week 6)||participants|||Number
120421|NCT00640042|Primary|Number of Subjects With Treatment Emergent Adverse Events|Adverse events that occur or worsen after the first dose of Avinza|Up to 4 months|||participants|||Number
120422|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study|Baseline (Week 0) to Visit 5 (Week 14 / End of Study)|Number of subjects with pain scores at Baseline (Week 0) and Visit 5 (Week 14 / End of Study)||units on scale||Standard Deviation|Mean
120423|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4|Baseline (Week 0) to Visit 4 (Week 10)|Number of subjects with pain scores at Baseline (Week 0) and Visit 4 (Week 10)||units on scale||Standard Deviation|Mean
120424|NCT00640042|Primary|Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)|Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3|Baseline (Week 0) to Visit 3 (Week 6)|Number of subjects with pain scores recorded at Baseline (Week 0) and Visit 3 (Week 6)||units on scale||Standard Deviation|Mean
120425|NCT00640016|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to 84|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
120426|NCT00640016|Secondary|Accumulation Ratio for CAT-354 (RA)|Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.|Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
120427|NCT00640016|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram*day/milliliter (mcg*day/mL)||Standard Deviation|Mean
120428|NCT00640016|Secondary|Minimum Observed Serum Concentration (Cmin) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|PK population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg/mL||Standard Deviation|Mean
120429|NCT00640016|Secondary|Maximum Observed Serum Concentration (Cmax) for CAT-354||Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
120430|NCT00640016|Secondary|Adult Asthma Quality of Life (QoL) Questionnaire Final Score|The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).|Day 0, 28, 84 or early termination (any time before Day 84)|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
120431|NCT00640016|Secondary|Morning Peak Flow and Peak Flow Variability|Peak flow is a participant’s maximum speed of expiration.|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
120432|NCT00640016|Secondary|Number of Participants With Exacerbations|Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).|Day 0 to Day 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
120433|NCT00640016|Secondary|Number of Participants With Diary Data|Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.|Day 0, 4, 14, 28, 35, 56, 63 to Day and 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
120434|NCT00640016|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Day 0 to 84|Data was not collected and hence, not analyzed for this outcome measure because the study was prematurely terminated on the basis of several factors namely, observed low rate of participant randomisation into the study; delay caused by temporary halt of study and potential for expiry date of investigation medicinal product before end of study.|||||
120447|NCT00639769|Primary|Patient Response|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|6 weeks after last chemotherapy treatment|Analysis was per protocol (7 patients did not receive a full cycle of treatment, and 1 patient was censored for incomplete records)||participants|||Number
120448|NCT00639717|Secondary|Regulatory T Cell Numbers Post-transplant||180 days|The original principal investigator of this trial has left the institution. This endpoint will not be analyzed.|||||
120449|NCT00639717|Secondary|Measured Level of Circulating Plasma Markers After Transplant||100 days|The original principal investigator of this trial has left the institution. This endpoint will not be analyzed.|||||
120435|NCT00640016|Secondary|Asthma Control Questionnaire (ACQ) Total Score|The ACQ is questionnaire that comprises of 7-questions evaluating participant’s asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 28, 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||units on a scale||Standard Deviation|Mean
120436|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)|Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||percentage of FVC||Standard Deviation|Mean
120437|NCT00640016|Secondary|Forced Vital Capacity (FVC)|The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||liters||Standard Deviation|Mean
120438|NCT00640016|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||liters||Standard Deviation|Mean
120439|NCT00640016|Secondary|Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline, Day 56, 84 or early termination (any time before Day 84)|Safety population included all participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure, and 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||log2 mg/dL||Standard Deviation|Mean
120440|NCT00640016|Primary|Change From Baseline in Doubling Concentration of Methacholine at Day 28|Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.|Baseline and Day 28|Safety population included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.||log2 milligram/deciliter (mg/dL)||Standard Deviation|Mean
120441|NCT00639860|Primary|New Bone Formation|Percentage of new bone formation of the alveolar bone core biopsies.|From Baseline to 12 weeks|||percentage of vital bone||Full Range|Mean
120442|NCT00639860|Primary|Radiographic Bone Changes|Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).|From Baseline to 12 weeks|||percentage of bone fill||Full Range|Mean
120443|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Stent to Apex)|Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks|||mm||Full Range|Mean
120444|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Mesiodistal)|Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks|||mm||Full Range|Mean
120445|NCT00639860|Primary|Change in Bone Gain or Loss in Millimeters (Buccopalatal)|Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.|From Baseline to 12 weeks|||mm||Full Range|Mean
120446|NCT00639769|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death|6 weeks after last chemotherapy|||participants|||Number
120453|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following Two IV Infusion Doses|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. For the participants that received two doses, blood samples for serum raxibacumab concentration measurement were collected from participants prior to administration of the raxibacumab and diphenhydramine doses on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose.|Pre-dose on Days 0 and 14, at 30 minutes and 2 to 6 hours after completion of each raxibacumab infusion, and at 28, 42, 56, and 70 days after the 1st raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
120454|NCT00639678|Secondary|Mean Raxibacumab Concentration-time Following a Single IV Infusion Dose|Blood was collected from each participant at selected times post dose, and serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics. Blood samples for serum raxibacumab concentration measurement were collected from participants who received a single-dose prior to administration of the raxibacumab and diphenhydramine doses on Day 0, at 30 minutes and 2 to 6 hours after completion of the raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose.|Pre-dose on Day 0, at 30 minutes and 2 to 6 hours after completion of raxibacumab infusion, and at 14, 28, and 56 days after the raxibacumab dose|Pharmacokinetics (PK) Population: all evaluable participants who received a raxibacumab dose and had at least 1 measurable post-dose serum raxibacumab concentration.||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
120455|NCT00639678|Primary|Number of Participants Who Developed an Anti-raxibacumab Antibody Response|Number of participants who developed an anti-raxibacumab antibody response during the study were assessed. .Immunogenicity testing was performed to determine if raxibacumab induced an anti-raxibacumab immune response. Testing comprised of 2 assays (screening and confirmatory). The screening assay (direct binding) was an electrochemiluminescence (ECL)-based bridging assay. A rabbit polyclonal antibody was used as a positive control. Samples above the assay cut point were considered positive. Samples identified as positive in the screening assay were confirmed positive in a confirmatory assay. Samples must have demonstrated a significant percent drop in the confirmatory inhibition of binding assay to be considered positive. The inhibition of binding confirmatory assay was performed identically to the direct binding screening assay with the exception that the samples were tested in parallel with excess unlabeled raxibacumab.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120456|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120457|NCT00639678|Primary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120458|NCT00639678|Primary|Number of Participants With Thyroid Toxicities of the Indicated Grade|Clinical thyroid parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120459|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities were assessed. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120460|NCT00639678|Primary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120461|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities were assessed. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120462|NCT00639678|Primary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120463|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities were assessed. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120464|NCT00639678|Primary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120465|NCT00639678|Primary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities were assessed. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
120466|NCT00639678|Primary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population||Participants|||Number
125634|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Peripheral Vascular’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
120467|NCT00639678|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the day of the first dose of study agent (Day 0) until Day 56 (single-dose) or until Day 70 (double-dose)|As-treated population: all participants who received at least one dose of study agent, with the assignment to treatment based on the actual treatment received, unless otherwise specified||Participants|||Number
120468|NCT00639509|Secondary|Median Overall Survival|Median Overall Survival|Post-Treatment|||months||95% Confidence Interval|Median
120469|NCT00639509|Primary|Best Overall Response Rate (ORR)|Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon’s optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.|From the start of the treatment until disease progression/recurrence|||participants|||Number
120470|NCT00639509|Primary|PFS Rate|PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon’s optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.|At 4 months|||percentage of participants||95% Confidence Interval|Number
120471|NCT00639457|Secondary|Myocardial Contractility-DBP|Diastolic blood pressure; vascular pressure during ventricular relaxation (diastole)|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||mmHg||Standard Error|Mean
120472|NCT00639457|Secondary|Myocardial Contractility-SBP|Systolic blood pressure; peak vascular pressure during ventricular contraction|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||mmHg||Standard Error|Mean
120473|NCT00639457|Secondary|Myocardial Contractility-DT|Deceleration time; time from the peak of early diastolic filling to baseline|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||msec||Standard Error|Mean
120474|NCT00639457|Secondary|Myocardial Contractility-LV Ejection Time|Time required to empty the left ventricle into the aorta|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||msec||Standard Error|Mean
120475|NCT00639457|Secondary|Myocardial Contractility|E/A ratio; ratio of the early (E) to late (A) ventricular filling velocities|Baseline and week 16|Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after ~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.||ratio||Standard Error|Mean
120476|NCT00639457|Secondary|Serum Adiponectin Levels||Baseline and week 16|||µg/mL||Standard Error|Mean
120477|NCT00639457|Secondary|Hematocrit|Percentage of blood volume that is red cells|Baseline and Week 16|||% red cells||Standard Error|Mean
120478|NCT00639457|Secondary|Hemoglobin||Baseline and Week 16|||g/L||Standard Error|Mean
120479|NCT00639457|Secondary|Liver Enzyme Levels||Baseline and week 16|||U/L||Standard Error|Mean
120480|NCT00639457|Secondary|Serum Lipid and Lipoprotein Levels||Baseline and week 16|||mM/L||Standard Error|Mean
120481|NCT00639457|Secondary|Hepatic Glucose Production Rate|ability of insulin to suppress hepatic glucose production = hepatic insulin sensitivity|Baseline and week 16|||percent suppression||Standard Error|Mean
120482|NCT00639457|Secondary|Hepatic Lipid Content||Baseline and week 16|||percent of water||Standard Error|Mean
120483|NCT00639457|Secondary|Abdominal Subcutaneous Fat Volume||Baseline and week 16|||cm3||Standard Error|Mean
120484|NCT00639457|Secondary|Visceral Fat Volume||Baseline and week 16|||cm3||Standard Error|Mean
120485|NCT00639457|Primary|Insulin-stimulated Glucose Disposal Rate|Insulin-mediated glucose disposal rate per kg of fat free mass per min|Baseline and week16|||µmol glucose/kg FFM/min||Standard Error|Mean
120486|NCT00639418|Secondary|Correlation of Office Vaccination-related Attitudes and Activities With Actual Vaccine Coverage|Correlation of office attitudes related to influenza vaccination and actual vaccine coverage was explored. Sites were asked to indicate level of agreement with the following recommendations: vaccinating children with high-risk medical conditions, patients 6 months to 5 years of age should be vaccinated against influenza each year, patients 5 to 18 years of age without high-risk medical conditions should be vaccinated against influenza each year, and previously unvaccinated patients less than 9 years of age receive 2 doses of vaccine.|Seasonal: 2007-2011|||Sites|||Number
120487|NCT00639418|Secondary|Compliance With the Recommended Two-dose Regimen in Vaccinated Participants|Compliance was calculated from the total number of participants receiving 2 doses divided by the total number of participants identified as requiring a second dose.|Seasonal: 2007-2011|||percentage of participants|||Number
120488|NCT00639418|Primary|Influenza Vaccine Coverage in Participants <18 Years of Age by Age Group in Pediatric Practices|Vaccine coverage was calculated from the number of participants vaccinated in each group, divided by the total number of participants under the practice’s care in that specific age group.|Seasonal: 2007-2011|||percentage of participants|||Number
120489|NCT00639379|Primary|Overall Corneal Staining|Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 2 weeks use|Subjects that completed the study were analyzed.||Units on a scale||Standard Error|Least Squares Mean
120490|NCT00639379|Primary|Subjective Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. >0=satisfactory vision, <0=unsatisfactory vision.|1 and 2 weeks|Subjects that completed the study were analyzed.||Units on a scale||Standard Error|Least Squares Mean
120491|NCT00639379|Primary|Subjective Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable.|1 and 2 weeks|Subjects that completed the study were analyzed.||Units on a scale||Standard Error|Least Squares Mean
120492|NCT00639379|Primary|Lens Stability|Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.|10-15 minutes after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.||Eyes|||Number
120493|NCT00639379|Primary|Lens Orientation Within 5 Degrees|Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.|1 minute after insertion|Subjects/eyes that completed the study were analyzed. A total of 168 eyes/84 subjects were analyzed.||Eyes|||Number
120494|NCT00639223|Secondary|Change in LDL-Cholesterol Measured at the Beginning and End of the Study||12 weeks|||Percentage Change||Standard Deviation|Mean
120495|NCT00639223|Primary|Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500||12 weeks|||Participants|||Number
120496|NCT00639158|Secondary|Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, last observation carried forward.||Percent change||Inter-Quartile Range|Median
120497|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit|[(Week 12 apoB minus baseline apoB)/baseline apoB] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoB value and at least 1 postbaseline apoB value, last observation carried forward.||Percent change||Standard Error|Mean
120498|NCT00639158|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, last observation carried forward.||Percent change||Standard Error|Mean
120499|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit|[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoCIII value and at least 1 postbaseline apoCIII value, last observation carried forward.||Percent change||Standard Error|Mean
120500|NCT00639158|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 weeks (final visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, last observation carried forward.||Percent change||Standard Error|Mean
120501|NCT00639158|Primary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward.||Percent change||Standard Error|Mean
120502|NCT00639158|Secondary|Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit|[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100|Baseline to 12 weeks (Final Visit)|All randomized subjects with a baseline apoAI value and at least 1 postbaseline apoAI value, last observation carried forward.||Percent change||Standard Error|Mean
120503|NCT00639158|Primary|Median Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward.||Percent change||Inter-Quartile Range|Median
120504|NCT00639093|Secondary|Tiffany's Urge to Smoke Questionnaire||Weeks 1, 4, 6, 12, 24 and 12-month follow-up||||||
120505|NCT00639093|Primary|Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.|"Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample.~Six measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up)."|Weeks 1, 4, 6, 12, 24 and 12-month follow-up|||participants|||Number
120506|NCT00639002|Secondary|Time to Disease Progression According to the International Uniform Response Criteria for Multiple Myeloma|"Progressive Disease requires 1 or more of the following:~Increase of ≥ 25% from baseline in:~Serum M-component and/or (increase ≥ 0.5 g/dL).~Urine M-component and/or (increase ≥ 200 mg/24 h).~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels increase must be > l0 mg/dL.~Bone marrow plasma cell percentage ≥ 10%.~Definite development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia."|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population. This outcome measure was not analyzed as no patients achieved a response.||Months||Standard Deviation|Mean
120637|NCT00637728|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
120507|NCT00639002|Primary|Number of Responders According to the International Uniform Response Criteria for Multiple Myeloma|A responder is defined as a patient with a complete response (negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow) or a partial response (≥ 50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥ 90% or to < 200 mg per 24 h).|Day 1 of Cycles 2, 3, and 4 and then every 3 months thereafter (up to 25 months).|Intent-to-treat population: All patients who were enrolled and took at least 1 dose of study medication.||participants|||Number
120508|NCT00638963|Secondary|Number of Participants Who Completed the Third Cycle of Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Participants|||Number
120509|NCT00638963|Secondary|Number of Participants Who Had at Least One Treatment Omission During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Participants|||Number
120510|NCT00638963|Secondary|Number of Participants Who Had at Least One Dose Reduction During Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Participants|||Number
120511|NCT00638963|Secondary|Total Dose of Temozolomide Taken|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Milligrams||Standard Deviation|Mean
120512|NCT00638963|Secondary|Number of Days on Temozolomide Treatment|This outcome measure was only applicable to the temozolomide arm; the observation arm was therefore not analyzed.|Baseline to 24 Weeks|||Days||Standard Deviation|Mean
120513|NCT00638963|Secondary|Number of Days With Brain Recurrence-free Survival (BRFS)|"BRFS was defined as the time interval from randomization to the appearance of brain metastases.~The analysis could not be performed due to low enrollment."|24,38, and 52 weeks||||||
120514|NCT00638963|Secondary|Number of Days With Distant Disease-free Survival (DDFS)|"DDFS was defined as the time interval from randomization to only distant metastases (for example, bone, visceral organ, brain).~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks||||||
120515|NCT00638963|Secondary|Number of Days With Disease-free Survival (DFS)|"DFS was defined as the time interval from randomization to any relapse (loco-regional, contra-lateral, and/or distant).~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks||||||
120516|NCT00638963|Secondary|Number of Days With Progression-free Survival (PFS)|"PFS was defined as the time interval from randomization to objective tumor progression or death from any cause.~The analysis could not be performed due to low enrollment."|24, 38, and 52 weeks||||||
120517|NCT00638963|Primary|Percent of Participants With Recurrence of Brain Metastases|The analysis could not be performed due to low enrollment.|1 Year||||||
120518|NCT00638937|Secondary|Overall Survival|"One year overall survival rate~The Kaplan-Meier method will be used."|1 year|||percentage|||Number
120519|NCT00638937|Secondary|Median Overall Survival|The Kaplan-Meier method will be used.|Up to 1 year|||months||95% Confidence Interval|Median
120520|NCT00638937|Secondary|Progression-free Survival|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause~The Kaplan-Meier method will be used."|6 months|||months||95% Confidence Interval|Median
120521|NCT00638937|Secondary|Median Progression-free Survival|The Kaplan-Meier method will be used.|From the date of study enrollment to the time the criteria for disease progression are met, death or last contact, or the last tumor assessment before the initiation of further anticancer therapy, assessed up to 1 year||||||
120522|NCT00638937|Secondary|Duration of Response or Stable Disease|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|From first response until the criteria for progression are met, assessed up to 1 year|||months||95% Confidence Interval|Median
120523|NCT00638937|Secondary|Stable Disease Rate|"Stabilization of disease for atleast 4 cycles, leading to disease control~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for progression are met, assessed up to 1 year|||participants|||Number
120524|NCT00638937|Secondary|Objective Response Rate (Complete and Partial Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions Overall Response (OR) = CR + PR~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|From the start of the treatment until the criteria for response are met|||participants|||Number
120525|NCT00638937|Primary|Rate of Disease Control (Freedom From Disease Progression)|"Lack of disease progression, a combined rate of objective complete (disapprearance of all target lesions) and partial responses (>= 30% decrease in sum of longest diameter of target lesions) and stable disease as determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.0) for at least 4 cycles (16 weeks) of therapy.~Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible."|112 days|||participants|||Number
120526|NCT00638924|Primary|Shuttle Walk Test Distance|The distance achieved in the test in meters|baseline|20 to 30 years old, healthy and sedentary||m||Standard Deviation|Mean
120527|NCT00638924|Secondary|Heart Rate|Heart rate at baseline|baseline|20 to 30 years old, healthy and sedentary||bpm||Standard Deviation|Mean
120528|NCT00638885|Primary|Neuropsychological Testing of Memory|Percent retention on the Wechsler Memory Scale - Logical|2 days|||percentage of WMS retention||Standard Deviation|Mean
120740|NCT00636818|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.||participants|||Number
120529|NCT00638846|Primary|Subjective Comfort|Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5.|2 weeks of lens wear|Analysis was performed on participants who completed the study per protocol.||units on a scale||Standard Error|Least Squares Mean
120530|NCT00638846|Secondary|Overall Corneal Staining|National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|After 2 weeks use|Analysis was performed on participants who completed the study per protocol.||units on a scale||Standard Error|Least Squares Mean
120531|NCT00638846|Secondary|Subjective Lens Vision|A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.|measured at 1 and 2 weeks|Analysis was performed on participants who completed the study per protocol.||units on a scale||Standard Error|Least Squares Mean
120532|NCT00638846|Secondary|Time to Fit Lens|Time required for the optometrist to fit the lens.|after lens insertion|Analysis was performed on participants who completed the study per protocol.||minutes||Standard Error|Least Squares Mean
120533|NCT00638846|Primary|Lens Stability|Lens stability is measured as the amount of rotation induced from blink after the lens has settled.|10-15 minutes after insertion|Analysis was performed on participants who completed the study per protocol.||proportion of eyes|Participants||Number
120534|NCT00638846|Primary|Lens Orientation|Proportion of eyes with lens orientation within 5 degrees of optimal|1 minute after insertion|Analysis was performed on participants who completed the study per protocol. The data represents 274 eyes that wore senofilcon A lenses and 278 eyes that wore balafilcon A lenses.||proportion of eyes|Participants||Number
120535|NCT00638820|Secondary|Differential Imaging and Biologic Evaluations|These outcome measures were not assessed due to early study termination.|Day 100, 6 months, 1, 2 and 5 years|||Participants|||Number
120536|NCT00638820|Secondary|Number of Patients With Transplant Related Toxicity|Number of patients experiencing adverse effects due to transplant categorized by body system using Common Terminology Criteria for Adverse Events coding from the National Cancer Institute, Version 3.0.|Day 100|||Participants|||Number
120537|NCT00638820|Secondary|Number of Patients With Transplant Related Death|Number of participants died during study by Day 100 and reason for death was related to transplant.|Day 100|||Participants|||Number
120538|NCT00638820|Primary|Number of Patients Achieving Donor Cell Engraftment|Number of patients with persistent presence of donor-derived cells at Day 100|Day 100|||Participants|||Number
120539|NCT00638690|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.|Up to 11 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Days||95% Confidence Interval|Median
120540|NCT00638690|Secondary|Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%|A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Participants|||Number
120541|NCT00638690|Secondary|Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria|The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.|Up to 12 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Days||95% Confidence Interval|Median
120542|NCT00638690|Primary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.|Up to 60 months|Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.||Days||95% Confidence Interval|Median
120543|NCT00638651|Secondary|Bleaching of the Tattoo||14 weeks||||||
120544|NCT00638651|Primary|Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream|To evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream (Aldara™, 3M/Graceway Pharmaceuticals, an immune response modifier) in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.|approximately 14 weeks|||percentage of tattoo pigment removed||Full Range|Mean
120545|NCT00638443|Secondary|Patient Global Assessment (PGA)|Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
120546|NCT00638443|Secondary|Roland Morris Disability Questionnaire|The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
120764|NCT00636649|Secondary|Change in Lipid Panel||Baseline,12 weeks|||mg/dL||Standard Error|Mean
120547|NCT00638443|Secondary|Modified Brief Pain Inventory (mBPI)- Interference Score|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven pain interference sub-scales. The final interference score is an average of the seven sub-scales (0 indicating no interference and 10 indicating complete interference).|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
120548|NCT00638443|Secondary|Swiss Spinal Stenosis- Physical Function|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
120549|NCT00638443|Secondary|Swiss Spinal Stenosis (SSS) Score- Symptom Severity|The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
120550|NCT00638443|Secondary|Oswestry Disability Index (ODI) Score|The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A total score range of 0-50; score of 0 indicates no disability and a score of 50 would indicate 100% disability.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
120551|NCT00638443|Secondary|Visual Analog Scale (VAS)|The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Deviation|Mean
120552|NCT00638443|Secondary|Area Under the Curve|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity multiplied by the amount of time the subject walked.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale * minutes||Standard Error|Mean
120553|NCT00638443|Secondary|Recovery Time|After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||minutes||Standard Error|Mean
120554|NCT00638443|Secondary|Total Distance|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||meters||Standard Error|Mean
120555|NCT00638443|Secondary|Final Pain as Measured by NRS|Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity. Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.||units on a scale||Standard Error|Mean
120556|NCT00638443|Primary|Time to First Symptoms of Moderate Pain|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.|10 days|The analyses included all enrolled randomized subjects according to the inclusion and exclusion criteria except for the three who withdrew from the trial prior to the completion of the study. One dropped out of the study due to an adverse event (dizziness).||minutes||Standard Deviation|Mean
120557|NCT00638378|Secondary|Number of Participants With a Complete Response or Partial Response|Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.|From Baseline through the end of study (up to 8 months)|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of tumor response rate was not assessed.||Participants|||Number
120765|NCT00636649|Secondary|Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2|The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.|12 weeks|||participants|||Number
120558|NCT00638378|Primary|Number of Participants With Adverse Events (AE)|A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|From Baseline through to the end of study (up to 8 months)|The Safety population included all enrolled patients who received at least 1 dose of study medication.||Participants|||Number
120559|NCT00638378|Secondary|Time to Progression|"The time from first dosing day to the date of disease progression:~Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results).~Development of unequivocal new lesions on bone scan without clinical suspicion of a “flare” reaction.~In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value.~In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value."|From Baseline until the end of study (up to 8 months).|According to the protocol, the sponsor decided to close the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response. Given that all patients discontinued the study due to lack of efficacy, the secondary endpoint of median time to progression was not assessed.||months||95% Confidence Interval|Median
120560|NCT00638378|Primary|Number of Participants With a Prostate-specific Antigen Response|A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.|Assessed monthly from Baseline until the end of study (up to 8 months)|The Intent-to-treat population, which included all patients enrolled in the study who took at least 1 dose of study medication.||participants|||Number
120561|NCT00638365|Primary|The Safety and Tolerability of a Single-dose of KB001.|Safety assessments were conducted after completion of day 28. AEs were followed through completion of day 56.|Day 28|Safety population: all subjects randomized and receiving any study medication.||Number of participants experiencing AEs|||Number
120562|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline||Percentage of participants||95% Confidence Interval|Number
120563|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline||percentage of participants||95% Confidence Interval|Number
120564|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with uterine descent >=stage II at baseline||Percentage of participants||95% Confidence Interval|Number
120565|NCT00638235|Other Pre-specified|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with uterine descent >=stage II at baseline||Percentage of participants||95% Confidence Interval|Number
120575|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
121799|NCT00626639|Secondary|Number of Participants With Disease Progression by Week 12|Disease progression was determined by clinical examination and histopathologic examination by the Investigator.|Up to Week 12|Tumor response data was missing for one participant.||participants|||Number
120566|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|24 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline||percentage of participants||95% Confidence Interval|Number
120567|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline||percentage of participants||95% Confidence Interval|Number
120568|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline||percentage of participant||95% Confidence Interval|Number
120569|NCT00638235|Primary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure|Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|Analysis includes only subjects with uterine descent >=stage II at baseline||percentage of participant||95% Confidence Interval|Number
120570|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120571|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120572|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120573|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120574|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120576|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120577|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M|Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120578|NCT00638235|Secondary|QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M|Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 6 months|Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||scores on a scale||Standard Deviation|Mean
120579|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120580|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120581|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M|Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .|baseline and 6 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120582|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|baseline and 24 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120583|NCT00638235|Secondary|QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.|12 months|QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120584|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 3 Months Post Procedure|Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure|baseline and 3 months|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||Percentage of participants||Standard Deviation|Mean
120585|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)||Percentage of participants|||Number
120586|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)||Percentage of participants|||Number
120587|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)||Percentage of participants|||Number
120601|NCT00638235|Secondary|Estimated Blood Loss|Estimated Blood Loss – defined as the estimated blood loss associated with the implantation of the study device, measured in ml|Approximately 30 minutes|||milliliters||Standard Deviation|Mean
120588|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)||Percentage of participants|||Number
120589|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.|12 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)||Percentage of participants|||Number
120590|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 months|How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)||Percentage of participants|||Number
120591|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)|"Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)||Percentage of participants|||Number
120592|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|12 months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)||Percentage of participants|||Number
120593|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months|"The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.~Note:~Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII~Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design"|24 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.||Percentage of participants||95% Confidence Interval|Number
120594|NCT00638235|Secondary|Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months|The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|6 months|POP-Q analysis employed last failure carried forward method, which carries subject’s objective failure at previous visits if the results are missing in the visit of interest. It’s also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.||Percentage of participants||95% Confidence Interval|Number
120595|NCT00638235|Secondary|Surgical Revision Rate|The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.|Through 24 months|Percentage of total subjects experienced surgical revision (%)||Percentage of participants|||Number
120596|NCT00638235|Secondary|Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)|Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.|6 Months|Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)||Percentage of participants|||Number
120597|NCT00638235|Secondary|Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure|"Pain – defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating hurts worst) at baseline, and 6 weeks post procedure"|baseline and 6 weeks|Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.||scores on a scale||Standard Deviation|Mean
120598|NCT00638235|Secondary|Rates of de Novo or Worsening Urinary and/or Anal Incontinence|Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence|Through 24 months|Rate of subjects experiencing different type of incontinenece (%)||Percentage of participants|||Number
120599|NCT00638235|Secondary|Rate of Graft Extrusions|Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall|Through 24 months|Rate of subjects experiencing graft exposure through the vagina (%)||Percentage of participants|||Number
120600|NCT00638235|Secondary|Percent of Subjects Experiencing Major Device Related Complications|This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure|Through 24 months|Total subjects experienced major complications(%)||Percentage of participants|||Number
120603|NCT00638235|Secondary|QoL Status – Defined as the Improvement in Subjects’ QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12|"Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline.~Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included."|6 Months|Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.||scores on a scale||Standard Deviation|Mean
120604|NCT00638235|Primary|Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure|Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.|12-months|"Analysis conducted only for those subjects with posterior vaginal wall prolapse >= stage II at baseline. Where a zero is indicated, no subjects meeting this criteria were enrolled."||percentage of participant||95% Confidence Interval|Number
120605|NCT00638222|Secondary|Plasma F2-isoprostanes||week 1, 8, 11, 18||||||
120606|NCT00638222|Secondary|Plasma NT-pro BNP||week 1, 8, 11, 18||||||
120607|NCT00638222|Secondary|Plasma Cardiac Troponin T||week 1, 8, 11, 18||||||
120608|NCT00638222|Secondary|Plasma C-reactive Protein||week 1, 8, 11, 18||||||
120609|NCT00638222|Secondary|Interleukin-6||week 1, 8, 11, 18||||||
120610|NCT00638222|Secondary|Oxidized LDL||week 1, 8, 11, 18||||||
120611|NCT00638222|Primary|Micro T- Wave Alternans||week 1, 8, 11, 18||||||
120612|NCT00638183|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data||Participants|||Number
120613|NCT00638183|Primary|Number of Patients With Adverse Events (AEs)|Number of patients with AEs|Pre treatment and 52 weeks after the treatment|373 patients were involved in the safety analysis data||Participants|||Number
120614|NCT00638183|Secondary|Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks|Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation|Pre treatment and 52 weeks after the treatment|All patients for which respiratory function testing was conducted at baseline and at 52 weeks||Liters||Standard Deviation|Mean
120615|NCT00638183|Secondary|Effective Rate of Comprehensive Evaluation|"Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.~Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided comprehensive evaluation.~comprehensive evaluation was classified into 3 category, improve No change+Aggravated and Unassessable by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of Improvement in total number of analyzed patients"|52 weeks|249 patient were evaluated the efficacy||percentage of effective patients|||Number
120616|NCT00638157|Secondary|Summary of the Investigator's Assessment of Clinical Response at the TOC Visit|TOC/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. Clinical response was assessed by the investigator as cure, improvement, failure, and unable to evaluate. Microbiological response, which was determined by the sponsor based on review of baseline and post-baseline culture results, included success, failure, and nonevaluable. TC=Treatment Cure; TF=Treatment Failure; TI=Treatment Improved.|TOC Visit|Modified Intent-to-Treat (mITT) population includes all ITT patients who received at least one dose of study medication.||Participants|||Number
120617|NCT00638157|Primary|Summary of Clinically Significant Increases in Serum Creatinine by Visit|The End of Treatment (EOT)/Early Termination (ET) visit occurred on the day that therapy was stopped or up to 2 days after the last dose of daptomycin. The Test of Cure (TOC)/Safety visit occurred 21 to 28 days after the last dose of daptomycin therapy. The overall median duration of treatment was 13.0 days in both the daptomycin group and the combination therapy group. The definition of elevated serum creatinine at baseline is >3.0 mg/dL, and not elevated is ≤3.0 mg/dL. Clinically significant increases in serum creatinine is defined as an increase ≥0.5 mg/dL for patients with a baseline value ≤3.0 mg/dL or ≥1.0 mg/dL for patients with a baseline value >3.0 mg/dL.|Baseline, EOT Visit, TOC|Safety Population includes all patients who received any dose of study medication.||Participants|||Number
120618|NCT00638027|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score Between Baseline and Week 12|"9-Hole Peg Test (9-HPT) is a quantitative measure of upper extremity function. Timed 25-Foot Walk (T 25 FW) is a quantitative measure of lower extremity function. The patient is instructed to walk 25 feet as quickly as possible, but safely.~Paced Auditory Serial Addition Test-3 seconds (PASAT-3) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.~The MSFC is based on the concept that scores for these 3 dimensions—arm, leg, and cognitive function are combined to create a single score that can be used to detect change over time in a group of MS patients. This is done by creating Z-scores for each component of the MSFC. Implicit in this approach is the idea that patients who deteriorate or improve on all 3 component measures will have an overall larger change than patients who change on only 1 of the 3 measures. The MSFC score was transformed to z-scores, with higher scores indicating better outcome."|Baseline, Week 12|Per protocol||Z score||Standard Deviation|Mean
120655|NCT00637377|Secondary|Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 – LOCF|The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||Scores on a scale||Standard Deviation|Mean
120619|NCT00638027|Secondary|Difference in the Multiple Sclerosis Spacticy Scale (MSSS-88) Between Baseline and 12 Weeks|"Multiple Sclerosis Spacticy Scale (MSSS-88) is a patient reported questionnaire rating scale to quantify the perspectives of the impact of spasticity on people with multiple sclerosis.~Scoring: Individual items are scored on a 4 point Likert scale: 1 (Not bothered at all), 2 (a little bothered), 3 (moderately bothered), 4 (extremely bothered).This questionnaire asks how bothered you have been by your spasticity in the past two weeks. By spasticity we mean muscle stiffness and spasms.The MSSS-88 is a reliable and valid, patient-based, interval-level measure of the impact of spasticity in multiple sclerosis. Scores were summed, without weighting or standardization, to generate ordinal-level total scores just as any other Likert-type scale. Missing responses to items can be replaced with the mean score of the items completed (person-specific item mean score) provided that 50% or more of the items in a scale have been completed. The range is 8-32 and higher scores mean poorer outcome."|baseline, 12 weeks|per protocol||units on a scale||Standard Deviation|Mean
120620|NCT00638027|Primary|Difference in Ashworth Spasticity Scale Score Between Baseline and 12 Weeks|"spasticity scale score: the most common used tool to measure the degree of spasticity of the lower extremities.~Score: Degree of Muscle Tone 0: no increase in tone~slight increase in tone 1+: slight increase in tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion.~more marked increase in muscle tone through most of the range of movement, but affected part(s) easily moved.~considerable increase in muscle tone, passive movement difficult.~affected part(s) rigid in flexion or extension."|Baseline and 12 weeks|Per Protocol||units on a scale||Standard Deviation|Mean
120621|NCT00638014|Secondary|Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union|The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications.|Up to 180 days|||Participants|||Number
120622|NCT00638014|Primary|Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved|Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).|Baseline, Maximum value during postoperatively days 1 thru 7|||percentage change||Standard Deviation|Mean
120623|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up|This analysis was conducted using only data for patients that completed the baseline through the end of follow-up time points.||participants|||Number
120624|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment|This analysis was conducted using only data for patients that completed the baseline through end of treatment time points.||participants|||Number
120625|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up|From baseline to week 16|This analysis was conducted using only data for patients that completed the baseline through week 16 time points.||participants|||Number
120626|NCT00637923|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8|This analysis was conducted using only data for patients that completed the baseline through week 8 time points.||participants|||Number
120627|NCT00637923|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment|||participants|||Number
120628|NCT00637923|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment|||participants|||Number
120629|NCT00637923|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment|||participants|||Number
120630|NCT00637923|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment|||participants|||Number
120631|NCT00637806|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study|||||
120632|NCT00637806|Secondary|Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline||Baseline, Week 4 and Week 8|Results not analyzed due to early termination of the study|||||
120633|NCT00637806|Secondary|Change in Weight Over the Course of the 8-week Double-blind Phase||Baseline, Week 1, 2, 3, 4, 6, and 8|Results not analyzed due to early termination of the study|||||
120634|NCT00637806|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week’s daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study|||||
120635|NCT00637728|Secondary|Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale|Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food|Baseline, Weeks 1, 2, 3, 4, 6 and 8|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
120638|NCT00637728|Primary|Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase|The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week’s daily caloric intake value.|8 weeks|Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.|||||
120639|NCT00637572|Secondary|Appetite at Baseline (Day 3) and Week 12|"Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was To what extent has your appetite changed since the start of treatment? The response was captured on a VAS scale in cm with a range from 0 ( much worse) to 10 (much better)."|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.||cm||Standard Deviation|Mean
120640|NCT00637572|Secondary|Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)|The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.|Baseline (Day 3) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.||cm||Standard Deviation|Mean
120641|NCT00637572|Secondary|Change in Total Energy|Food intake was quantified by the 24-hour recall food diary|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 27 subjects and 22 subjects were analyzed, respectively based on available baseline data.||kcal||Standard Deviation|Mean
120642|NCT00637572|Secondary|Change in Mid-arm Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit||cm||Standard Deviation|Mean
120643|NCT00637572|Secondary|Change in Tricep Skinfold||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit||cm||Standard Deviation|Mean
120644|NCT00637572|Secondary|Change in Waist Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available data measurements.||cm||Standard Deviation|Mean
120645|NCT00637572|Secondary|Change in Hip Circumference||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects and 29 subjects were analyzed, respectively based on available baseline measurements.||cm||Standard Deviation|Mean
120646|NCT00637572|Secondary|Change From Baseline in Body Fat Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.||kg||Standard Deviation|Mean
120647|NCT00637572|Secondary|Change From Baseline in Impedance|Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.||ohms||Standard Deviation|Mean
120648|NCT00637572|Secondary|Change From Baseline in Lean Mass||Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.||kg||Standard Deviation|Mean
120649|NCT00637572|Primary|Change in Body Weight|Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment|Baseline (Day 1) to Week 12|Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit||kg||Standard Deviation|Mean
120650|NCT00637494|Secondary|The Change in a Standardized Psychiatric Rating Scale Score.||56 days||||||
120651|NCT00637494|Secondary|The Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Above a Specified Amount Versus Placebo Treated Patients Who Achieve a Score Reduction From Baseline on a Standardized Psychiatric Rating Scale.||56 days||||||
120652|NCT00637494|Primary|Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in BPRS-PSS at Days 7 and 56.||56 days|||participants|||Number
120653|NCT00637416|Primary|Change in Condition Over Treatment Period|Change measured using voice assessment protocol—Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).|3 months|Study was stopped early, data were not collected, and zero participants were analyzed.|||||
120654|NCT00637377|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 – LOCF|CNV area values measured in square millimeters; lower values represent better outcomes.|Baseline and at week 52|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF||mm^2||Standard Deviation|Mean
125635|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Cardiovascular’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
120656|NCT00637377|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 – LOCF|"Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.~Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Full-Analysis Set; imputation technique: LOCF||Percentage of participants|||Number
120657|NCT00637377|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 – LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|Full-Analysis Set (FAS); imputation technique: LOCF||Letters correctly read||Standard Deviation|Mean
120658|NCT00637377|Primary|Percentage of Participants Who Maintained Vision at Week 52 – Last Observation Carried Forward (LOCF)|"Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.~Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed."|At week 52|Per-Protocol Set (PPS); imputation technique: LOCF||Percentage of participants|||Number
120659|NCT00637312|Primary|Evaluation of Device and/or Procedure Related Adverse Event(s)||At 24-months|The study was suspended for higher than anticipated adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent treatment group. Agency approval is not being pursued for this device and thus no analysis has been completed.|||||
120660|NCT00637299|Secondary|Lung Function Test|residual volume (RV)|4 weeks|||liters||Standard Deviation|Mean
120661|NCT00637299|Primary|Walking Ability|6 minutes walking test (6MWT)|4 weeks|||meters||Standard Deviation|Mean
120662|NCT00637273|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 26|ITT Population.||rate per subject-year||Standard Error|Mean
120663|NCT00637273|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||Standard Error|Least Squares Mean
120664|NCT00637273|Secondary|Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26|Change in fasting HDL from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
120665|NCT00637273|Secondary|Change in Fasting Total Cholesterol From Baseline to Week 26|Change in fasting total cholesterol from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
120666|NCT00637273|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26|Change in diastolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
120667|NCT00637273|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mmHg||Standard Error|Least Squares Mean
120668|NCT00637273|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26|Change in fasting plasma glucose from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
120669|NCT00637273|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline (Day 1) to Week 26.|Day 1, Week 26|ITT Population. Missing data up to Week 26 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||Standard Error|Least Squares Mean
120670|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.||percentage of subjects|||Number
120671|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.||percentage of subjects|||Number
120689|NCT00637195|Secondary|Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
120672|NCT00637273|Secondary|Percentage of Subjects Achieving HbA1c Target of <7% at Week 26|Percentages of subjects achieving HbA1c target values of <7% at Week 26.|Week 26|ITT Population. Missing data up to Week 26 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline HbA1c measurement were categorized as not achieving goal.||percentage of subjects|||Number
120673|NCT00637273|Primary|Change in HbA1c From Baseline to Week 26|Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].|Day 1, Week 26|The ITT Population included randomized subjects who received at least one injection of study medication. Missing data up to Week 26 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||Standard Error|Least Squares Mean
120674|NCT00637247|Secondary|To Evaluate the OS, ORR, PFS, 1-year Survival, and Changes in CA19.9 of Subjects on the Two Treatment Arms That Completed > 1 Cycle (28 Days) of Protocol Treatment||one year||||||
120675|NCT00637247|Secondary|To Evaluate the Changes in Blood Levels of CA19.9 on the Two Treatment Arms and Whether There is a Relationship to Objective Response, and PFS||one year||||||
120676|NCT00637247|Secondary|One Year Survival|To evaluate the 1-year survival rates of the two treatment arms.|one year||||||
120677|NCT00637247|Secondary|Progression Free Survival|To compare the median progression free survival (PFS) of the two treatment arms. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects were censored if no documented progression had occurred at the one year time point. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|one year|Intention to treat||months|Participants|95% Confidence Interval|Median
120678|NCT00637247|Secondary|Objective Response Rates of the Two Treatment Arms|Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|one year|Per protocol, response evaluable population was treated and had baseline and at least one response evaluation.||percent of responses|||Number
120679|NCT00637247|Primary|To Evaluate and Compare the Tolerability and Toxicity of the Two Treatment Arms||up to 2 years||||||
120680|NCT00637247|Primary|Overall Survival for the Intent to Treat Population|To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.|up to 2 years|Intention to treat with subjects who were alive at the time of the survival analysis or lost to follow-up were considered censored at the last date the subject was known to be alive.||months||95% Confidence Interval|Median
120681|NCT00637195|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120682|NCT00637195|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to study end (Month 13)|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120683|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120684|NCT00637195|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120685|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.~Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120686|NCT00637195|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.~Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120687|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.~Data are presented across doses."|During the 7-day period following the 4th dose of HBV vaccine|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120688|NCT00637195|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include injection site pain, redness and swelling.~Data are presented across doses."|During the 7-day period following any vaccination|Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.||subjects|||Number
120690|NCT00637195|Secondary|Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course|A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.|Months 2 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||subjects|||Number
120691|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies|Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.|Months 2, 3 and 13|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||subjects|||Number
120692|NCT00637195|Secondary|Anti-HPV-16/18 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|Months 2 and 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data.||EL.U/mL||95% Confidence Interval|Geometric Mean
120693|NCT00637195|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination.~Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|Months 2 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data.||subjects|||Number
120694|NCT00637195|Primary|Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix|Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.||mIU/mL||95% Confidence Interval|Geometric Mean
120695|NCT00637195|Primary|Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix|A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).|Month 3|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination .||subjects|||Number
120696|NCT00637156|Secondary|Change of General Health Status -- SF-36 MCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
120697|NCT00637156|Secondary|Change of General Health Status -- SF-36 PCS From Baseline|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
120698|NCT00637156|Secondary|Change of Arm Pain Score From Baseline|"Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline."|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
120699|NCT00637156|Secondary|Change of Neck Pain Score From Baseline|"Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline."|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
120700|NCT00637156|Secondary|Change of Neck Disability Index Score From Baseline|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.|Baseline and 24 months post-operation|||units on a scale||Standard Deviation|Mean
120701|NCT00637156|Secondary|Rate of Secondary Surgery at Index Level|Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.|24 months|||percentage of participants|||Number
120702|NCT00637156|Secondary|Hospital Stay||From admission to discharge, an average of 1.0-1.5 day|||days||Standard Deviation|Mean
120703|NCT00637156|Secondary|Blood Loss||During the time of operation, an average of 1.7-2.1 hrs|||ml||Standard Deviation|Mean
120704|NCT00637156|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, an average of 1.7-2.1hrs|||hrs||Standard Deviation|Mean
120899|NCT00635570|Secondary|Continuation Rate|Rate of intention to continue the contraceptive method at 3 months|at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)||Percentage of Participants|||Number
120705|NCT00637156|Secondary|Gait Success Rate|Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
120706|NCT00637156|Secondary|Rate of Disc Height Success|Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.||percentage of participants|||Number
120707|NCT00637156|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.||percentage of participants|||Number
120708|NCT00637156|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.||percentage of participants|||Number
120709|NCT00637156|Secondary|Arm Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
120710|NCT00637156|Secondary|Neck Pain Success Rate|"Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0."|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
120711|NCT00637156|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
120712|NCT00637156|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months|For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.||percentage of participants|||Number
120713|NCT00637156|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;~Maintenance or improvement in neurological status;~No serious adverse event classified as implant associated or implant/surgical procedure associated; and~No additional surgical procedure classified as a “failure.”"|24 Months|The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.||percentage of participants|||Number
120714|NCT00637000|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-emergent AEs were defined as those starting on the day of the first treatment with buprenorphine soluble films or buprenorphine/ naloxone soluble films until residential research facility release, which typically happened on Day 6.~Severity was graded by the investigator as mild (grade 1), moderate (grade 2) and severe (grade 3)."|Day 1-6|The randomized population included all subjects who were randomized to soluble films and received at least one dose of soluble films.||participants|||Number
120900|NCT00635570|Secondary|Satisfaction Rate||at 3 months|26 participants, 15 out of the contraceptive vaginal ring group and 11 out of the oral contraceptive pill group were excluded. (See the participant flow chart)||Percentage of Participants|||Number
120715|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Does the Drug Make You Sick?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug make you sick?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120716|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Like the Drug?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you like the drug?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120717|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Does the Drug Have Any Bad Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug have any bad effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120718|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Feel Any Good Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any good effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120719|NCT00637000|Secondary|Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: “Do You Feel Any Drug Effect?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any drug effect?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120720|NCT00637000|Secondary|"Visual Analog Scale (VAS) Scores at End of Induction Period and the Post-induction Period (Maximum Increase) for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120721|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Make You Sick?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug make you sick?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
121949|NCT00625404|Primary|Confirmed Grade 3 or Higher Reduction in Phosphorus|Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL|Through 52 weeks on product and 4 weeks post-product|||participants|||Number
120722|NCT00637000|Secondary|CVisual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Do You Like the Drug?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you like the drug?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no liking and 100=maximum liking.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120723|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Have Any Bad Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Does the drug have any bad effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no bad effects and 100=maximum bad effects.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120724|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Does the Drug Have Any Good Effects?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any good effects?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no good effects and 100=maximum good effects.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120725|NCT00637000|Secondary|Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: “Do You Feel Any Drug Effect?”|A visual analog scale (VAS) was used by participants to answer the subjective question, “Do you feel any drug effect?”. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=no effect and 100=maximum effect.|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120726|NCT00637000|Secondary|"Visual Analog Scale (VAS) Score at Baseline and the Peak (Maximum Increase) VAS up to 23.5 Hours After First Administration for the Question: How High Are You?"|"A visual analog scale (VAS) was used by participants to answer the subjective question, How high are you?. The question was one of six used to measure the extent of opioid blockade following study intervention. VAS questions were selected based on previous demonstration of their sensitivity to opioid agonist and antagonist effects (Preston et al., 1988). Participants indicated how high they feel by marking a score on a horizontal line with 0=not high and 100=extremely high.~The baseline VAS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak VAS was the highest VAS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120727|NCT00637000|Secondary|Pupil Diameter Measurements At End of Induction (End of Day 2) and the Minimum Pupil Diameter During the Post Induction Period (Days 3-5)|Pupil diameter was measured at the end of induction (47.5 hours after the first administration of study intervention) and at intervals during the post-induction period (Days 3-5). Peak post induction measurement is the minimum pupil diameter recorded during days 3-5.|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||mm||Standard Deviation|Mean
120728|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Minimum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the minimum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||mm||Standard Deviation|Mean
120739|NCT00636818|Secondary|Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.||participants|||Number
120729|NCT00637000|Secondary|Pupil Diameter Measurements at Baseline and the Maximum Pupil Diameter up to 23.5 Hours After the First Administration|Pupil diameter was measured at baseline and at intervals post drug administration on Day 1. Peak measurement is the maximum pupil diameter recorded from 15 minutes to 23.5 hours post administration of study intervention.|Baseline: 15 minutes prior to first administration on Day 1. Peak: 15 minutes - 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||mm||Standard Deviation|Mean
120730|NCT00637000|Secondary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at the End of Induction and the Peak COWS Post Induction|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The end of induction COWS was the score obtained 47.5 hours after first administration of soluble films on Day 1. Peak post induction COWS was the highest COWS score obtained on Days 2-5."|End of Induction: 47.5 hours after first administration Peak Post Induction: Days 3-5|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120731|NCT00637000|Primary|Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration|"The COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the response to each of the 11 items and cover a range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal.~The baseline COWS was the score obtained 30 minutes prior to administration of soluble films on Day 1. Peak COWS was the highest COWS score obtained between 1-23.5 hours post administration on Day 1."|Baseline: 30 minutes prior to first administration on Day 1. Peak: up to 23.5 hours post administration on Day 1|Per protocol, the evaluable population includes all subjects randomized to the study who completed the study through the first two days of soluble films administration and assessments for 23.5 hours after the first day of soluble films administration.||units on a scale||Standard Deviation|Mean
120732|NCT00636961|Secondary|Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14|The modified Borg CR10 Scale consists of 12-point score that the patients point to so as to indicate their level of dyspnoea (where 0 indicates no breathlessness at all to 12 indicates maximum breathlessness), before and during exercise testing. A reduction in this score indicates an improvement. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests. Peak time was defined as the last measurement taken in the exercise period. Analysis of variance included period, treatment and sequence as fixed effects and subject as random effect.|Day 1, Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Score on a scale||90% Confidence Interval|Least Squares Mean
120733|NCT00636961|Secondary|Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14|Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Score on a scale||90% Confidence Interval|Least Squares Mean
120734|NCT00636961|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Liters||90% Confidence Interval|Least Squares Mean
120735|NCT00636961|Secondary|Static Inspiratory Capacity (IC) at Day 14|Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate,|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Liters||90% Confidence Interval|Least Squares Mean
120736|NCT00636961|Primary|Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14|Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.|Day 14|The safety analysis set consisted of all patients who received study medication and had at least one assessment.||Liters||90% Confidence Interval|Least Squares Mean
120737|NCT00636818|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 Weeks|Number of participants who received at least one dose of study drug.||participants|||Number
120738|NCT00636818|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval (QTcF) was used.|Baseline to 8 Weeks|Number of participants with baseline and post-baseline values.||participants|||Number
120741|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)|SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score*10+50 in each subscale. Range cannot be specified in norm-based scores.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||T-Score||Standard Deviation|Mean
120742|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Stroop Color Word Test|This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||number of correct answers||Standard Deviation|Mean
120743|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)|The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
120744|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
120745|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
120746|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
120747|NCT00636818|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score|Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.|Baseline and 8 Weeks|Number of participants who received at least one dose of study drug and had a baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
120748|NCT00636818|Primary|Discontinuations Due to Adverse Events (AE)|The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.|Baseline to 8 Weeks|Number of participants who received at least one dose of study drug.||participants|||Number
120749|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from the mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue. Acute CINV complete response (CR) is defined as not having an emetic episode or any use of antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy||units on a scale||95% Confidence Interval|Mean
120777|NCT00636610|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to the earlier of documented disease progression (PD) or death from any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. For patients without measurable disease, PD was defined as an increase in the size of a lesion to one that is measurable or unequivocal progression of a non-target lesion.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients.||Months||90% Confidence Interval|Median
120750|NCT00636805|Secondary|Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy|Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue.|Baseline through day 5 of the first week of chemotherapy|Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy||units on a scale||95% Confidence Interval|Mean
120751|NCT00636805|Secondary|Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities|Percentage of patients with ≥ grade 3, treatment-related toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|6 weeks|||participants|||Number
120752|NCT00636805|Secondary|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate|Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during days 2 through 5 of chemotherapy treatment during the first cycle of treatment|Days 2-5 of the first week of chemotherapy|Intent-to-treat; 10 patients did not complete the study measure for days 2-5 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
120753|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
120754|NCT00636805|Secondary|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|Day 1 of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
120755|NCT00636805|Primary|Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate|Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.|first 24 hours of the first week of chemotherapy|Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy||percentage of participants||95% Confidence Interval|Number
120756|NCT00636792|Secondary|Number of Participants With Overall Response (Complete and Partial Response)|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.|12 weeks after the last subject completes their end of treatment visit|||participants|||Number
120757|NCT00636792|Primary|Number of Participants With Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|12 weeks after the last subject completes their end of treatment visit.|Response-evaluable population is defined at patients treated with 90 mg/m^2 bendamustine, received at least one dose of any study drug, and had at least one post baseline response assessment.||participants|||Number
120758|NCT00636701|Primary|Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks|Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .|Baseline (day 0) and 2 weeks|Four right‐handed healthy volunteers (two men, aged 20–50 years) participated in a double‐blind study of primed and unprimed rTMS.||percentage change of BOLD||Standard Deviation|Mean
120759|NCT00636649|Secondary|Number of Participants Who Had a 50% Reduction in NEQ Scores|The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.|Week 12|||participants|||Number
120760|NCT00636649|Secondary|Number of Participants Who no Longer Meet the NESHI Criteria|The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.|Week 12|||participants|||Number
120761|NCT00636649|Secondary|Change in Weight||Baseline, 12 week|||kg||Standard Error|Mean
120762|NCT00636649|Secondary|Change in Glucose||Baseline, 12 Week|||mg/dL||Standard Error|Mean
120763|NCT00636649|Secondary|Change in Beck Anxiety Inventory (BAI) Score|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.|Baseline, 12 weeks|||units on a scale||Standard Error|Mean
120766|NCT00636649|Secondary|Change in Three Factor Eating Questionnaire (TFEQ)|"The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).~RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale"|Baseline, 12 weeks|||units on a scale||Standard Error|Mean
120767|NCT00636649|Secondary|Change in Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|12 weeks|Participants who completed PSS assessment at baseline and week 12.||units on a scale||Standard Error|Mean
120768|NCT00636649|Secondary|Change in Coping Inventory for Stressful Situations (CISS)|TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.|Baseline, 12 weeks|||t-scores||Standard Error|Mean
120769|NCT00636649|Secondary|Change in Beck Depression Inventory II (BDI-II) Score|The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.|Baseline, 12 weeks|||units on a scale||Standard Error|Mean
120770|NCT00636649|Primary|Night Eating Questionnaire|The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.|baseline, 12 weeks|Data were analyzed as intent-to-treat with all 40 patients included in the analysis. Primary endpoint was change in the NEQ total score, i.e., difference between values between Week 12 (study exit) and baseline. Analysis of covariance was the primary statistical procedure with baseline NEQ score and baseline BMI as covariates.||units on a scale||Standard Error|Mean
120771|NCT00636636|Other Pre-specified|Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10).|10 weeks|||Scores on a scale||Standard Error|Least Squares Mean
120772|NCT00636636|Secondary|Average Daily Sleep Interference Score|Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10).|10 weeks|||Scores on a scale||Standard Error|Least Squares Mean
120773|NCT00636636|Secondary|Clinical Global Impression of Change (CGIC)|"Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks|||Participants|||Number
120774|NCT00636636|Secondary|Patient Global Impression of Change (PGIC)|"Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)."|10 weeks|ITT, BOCF||Participants|||Number
120775|NCT00636636|Primary|Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score|Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10).|10 weeks|ITT, BOCF||Scores on a scale||95% Confidence Interval|Least Squares Mean
120776|NCT00636610|Secondary|Progression-free Survival (PFS) in Patients With Various Degrees of Hedgehog Antigen Tumor Expression|Indian + Sonic Hedgehog antigen expression was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from archival tumor tissue taken from each patient prior to enrollment in the study. Results are reported in 3 categories; the 33% of patients with the lowest level of expression, the 35% of patients with a middle level of expression, and the 32% of patients with the highest level of expression. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason.|From first treatment through the data cut-off date of March 15, 2010, up to 90 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 64 patients in the vismodegib group and 75 patients in the placebo group.||Months||90% Confidence Interval|Median
120834|NCT00636207|Primary|Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL*hr||Standard Deviation|Mean
120778|NCT00636441|Secondary|Patients' Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for PST of Early-stage Breast Cancer.|A short questionnaire was administered at baseline (the day chemotherapy was started) and following post-surgical medical oncology evaluation to assess the patient’s understanding of the study being conducted, and the patient’s expectations of the treatment. Due to space limitations, the full survey is presented in the Detailed Description.|1 year|The overall enrollment was insufficient to provide for any substantive analysis.|||||
120779|NCT00636441|Secondary|Economic Impact of Using Genomic Assessment to Guide Management.|Economic Impact (i.e., cost of care) will be calculated by first assessing the quantity of clinical resources used by each patient in the study arm, and then assigning a cost to each resource using cost information derived from a costing study to be undertaken outside of this protocol.|5 years|Since these data were not collected, this analysis could not be done.|||||
120780|NCT00636441|Secondary|Overall Survival|Overall survival is defined as the time from enrollment to death due to any cause. The 2-year overall survival rate is estimated with the Kaplan-Meier method.|2 years|All eligible treated patients with known follow-up status.||Estimated % of participants surviving||95% Confidence Interval|Number
120781|NCT00636441|Secondary|Sites of Recurrence|Sites of Recurrence is a categorical outcome whose possible values are the organ-specific sites at which disease recurrence was observed. A patient may recur at more than one site.|10 years|All eligible treated patients. Four of these 38 participants experienced recurrence of their breast cancer; two of the four patients had multiple sites of recurrence.||participants|||Number
120782|NCT00636441|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time from enrollment to local or distant disease recurrence, whichever comes first; disease-free deaths are censored. The 2-year disease-free survival rate is estimated with its 95% confidence interval.|2 years|All eligible treated patients were used in this analysis.||estimated % of participants disease-free||95% Confidence Interval|Number
120783|NCT00636441|Secondary|Clinical Response Using WHO Criteria|"WHO criteria are based on the sum of the products of the longest axis and the longest perpendicular axis. Bi-dimensional measurements were taken of all breast lesions and axillary nodes using the best imaging modality performed after completion of assigned therapy.~Clinical Complete Response (cCR): Disappearance of all target lesions by physical exam and best imaging modality.~Clinical Partial Response (cPR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum LD at treatment initiation. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.~Progression (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesion."|12 weeks, 2-3 weeks after the fourth cycle of chemotherapy|All eligible treated patients were used in this analysis.||participants|||Number
120784|NCT00636441|Secondary|To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.|The percentage of patients who had breast-conserving surgery at first attempt, measured only in patients with T2 tumors classified as potential candidates for breast conservation.|6 months|Data from all eligible patients with non-missing values on this outcome were used.||percentage of T2 tumor patients||95% Confidence Interval|Number
120785|NCT00636441|Secondary|Percentage of Patients Who Had Breast-conserving Surgery With Negative Margins|The percentage of patients who had breast-conserving surgery with negative margins, measured in patients with T2 and T3 tumors classified as requiring mastectomy at baseline.|6 months|Since final margin status was not collected, this analysis could not be done.|||||
120786|NCT00636441|Secondary|Probabilities of Being Sensitive to AC and TC as Determined by the Patient’s Genomic Signatures|To determine in early stage breast cancer treated with PST whether genomic profiling can identify drug-sensitive and drug-resistant patients including a comparison of subgroups for the two individual regimens (i.e. AC and TC). To determine if the 60% cutoff for the genomic profiles is optimal in predicting the response to chemotherapy regimens.To describe the performance of the genomic profiles in assessing the relative responsiveness of: 1) Patients predicted to be resistant to both chemotherapy regimens; and 2) Patients randomly assigned to one treatment whose genomic profiles suggest receiving the other regimen (in both AC and TC subgroups).|10 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates|||||
120787|NCT00636441|Primary|Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer|Pathological complete response (pCR) was defined as the disappearance of all invasive disease in the breast or if only residual in situ or lymph node disease is found. The pCR rate is presented with its 95% confidence interval for the Guided and Non-guided arms.|4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks|All eligible treated patients. The three patients not included are two who had allergic reactions to the assigned treatment, and one with metastatic disease on biopsy of a spine lesion at the end of assigned treatment so never went to surgery.||percentage of participants||95% Confidence Interval|Number
120788|NCT00636389|Primary|A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.|Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|||Percentage of reduction||Standard Deviation|Mean
120789|NCT00636389|Secondary|Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H|Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor /|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|Each of the 12 subjects underwent three consecutive treatments with the HD-C4 and three consecutive treatments with the Polyflux 210H.||Units on a Scale 1 = Best|Participants|Standard Deviation|Mean
120835|NCT00636207|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 7 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug||participants|||Number
120790|NCT00636389|Primary|Comparison of Urea Removal Under Conditions of Routine Hemodialysis.|Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.|2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments|||ratio||Standard Deviation|Mean
120791|NCT00636363|Primary|Contact Lens Deposits|Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.|At each visit for 3 months|Lens deposits, All eligible, dispensed eyes.||Eyes|Participants||Number
120792|NCT00636363|Primary|Subjective Responses to Comfort Related Symptoms/Complaints|Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.|Over 4 visits for the 3 month period|Comfort related symptoms/complaints for all eligible, dispensed eyes. Over all follow-up visits.||Scores on a Scale|Participants|Standard Deviation|Mean
120793|NCT00636363|Primary|Slit-lamp Findings > Grade 2|eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.|Over 4 visits for 3 month period|Over all follow-up visits, all dispensed eyes||participants|Participants||Number
120794|NCT00635232|Secondary|The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.||12 weeks|Full analysis set (LOCF)||participants|||Number
120795|NCT00635232|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks|||mm Hg||Standard Deviation|Mean
120796|NCT00635232|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.||12 weeks|The primary efficacy population was the Full Analysys Set (FAS) population= all randomized subjects who took at least one dose of the assigned study drug and had both baseline and post-baseline mean seated SBP. Both LOCF and observed-data set approach were performed.||mm Hg||Standard Deviation|Mean
120797|NCT00635219|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient’s recent sexual experience. Patients are asked to assess their own experience over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
120798|NCT00635219|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
120799|NCT00635219|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
120800|NCT00635219|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF; Logistic Regression||percentage of patients|||Number
120801|NCT00635219|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|SDS is a patient-reported outcome. The SDS Total Score is the sum of work, social life, or leisure activities, and home life or family responsibilities. FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
120802|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20||Baseline and Week 8|Patients With Baseline HAM-A Total Score >=20: FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
120803|NCT00635219|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
120804|NCT00635219|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS; LOCF; Logistic Regression||percentage of patients|||Number
120805|NCT00635219|Secondary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA||units on a scale||Standard Error|Mean
120836|NCT00636207|Primary|Number of Participants Who Experienced At Least One Adverse Event||Up to 14 days after last dose of study drug|Safety Population: All participants who received at least one dose of study drug||participants|||Number
120806|NCT00635219|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)||units on a scale||Standard Error|Mean
120807|NCT00633477|Secondary|Ventilator Free Days.|Number days participant was not on Ventilattor support.|Day 28|This study was terminated early when 17 subjects had received treatment.||Days|||Number
120808|NCT00633477|Secondary|Vasopressor Free Days.|Number days participant did not need vasopressors.|Day 28|This study was terminated early when 17 subjects had received treatment.||days|||Number
120809|NCT00633477|Secondary|ICU Free Days|Number days participant was not in ICU|Day 28|This study was terminated early when 17 subjects had received treatment.||days|||Number
120810|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug||Percent of Participant|||Number
120811|NCT00633477|Primary|All-cause Mortality|Mortality regardless of cause at Day 28|Day 28|Participants who received study drug.||Participants|||Number
120812|NCT00633464|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase: GR1=>ULN–2.5*ULN (upper limit of normal); GR2=>2.5–5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN–1.5*ULN, GR2=>1.5–3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN–1.5*ULN, GR2=>1.5–3.0*ULN, GR3=>3.0–6.0*ULN, GR4=>6.0*ULN.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.||participants|||Number
120813|NCT00633464|Primary|Number of Participants With Best Overall Response as Assessed With Response Criteria in Solid Tumors (RECIST)|PD = At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.|Assessed at 6 week intervals for first 12 months from randomization, thereafter every 3 months (to a maximum follow-up for tumor response of 17 months).|All randomized participants.||participants|||Number
120814|NCT00633464|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Hemoglobin:GR1=<LLN–10.0g/dL; GR2=<10.0–8.0g/dL; GR3:<8.0–6.5g/dL, GR4:<6.5g/dL. Platelets:GR1=<LLN–75.0*10^9/L; GR2=<75.0–50.0*10^9/L; GR3:<50.0–25.0*10^9/L, GR4:<25.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN–1.5*10^9 /L; GR2=<1.5–1.0*10^9/L; GR3:<1.0–0.5*10^9/L; GR4:<0.5*10^9/L. White blood cell (WBC):GR1=<LLN–3.0*10^9/L; GR2=<3.0–2.0*10^9/L; GR3:<2.0–1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal.|Assessed prior to 1st cycle, at beginning of each cycle, weekly (cetuximab treatment), and every 4 weeks within 30 days after last dose of study drug. Median time on ixapebilone therapy: 15 weeks (range:3-54:ixabepilone arm;3-36:ixapebilone+cetuximab arm)|Treated participants: Participants who received any treatment (ixabepilone or cetuximab). n=number of participants with measures available at the time.||participants|||Number
120815|NCT00633464|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. Other reasons for death included hepatic failure and respiratory distress.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 15 weeks (range: 3-54 weeks for ixabepilone arm; 3-36 weeks for ixabepilone+cetuximab arm)|All treated participants: Participants who received any treatment (ixabepilone or cetuximab).||participants|||Number
120816|NCT00633464|Secondary|Duration of Response|Defined as period from the time that measurement criteria are first met for CR or PR until first date of documented PD or death. Estimated using the Kaplan-Meier product-limit method; CI was computed using Brookmeyer and Crowley method. CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of LD of all target lesions with reference to baseline sum LD. PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 15.6 months)|Randomized participants with response of CR or PR. Participants who did not relapse or die were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
120837|NCT00636194|Secondary|Graded Slit Lamp Findings > Grade 2|Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.|2 week follow-up visit|All dispensed, completed eyes||eyes|Participants||Number
120838|NCT00636194|Secondary|Symptoms and Complaints|Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.|2 weeks|All eligible, dispensed eyes||Score on a scale|Participants|Standard Deviation|Mean
120817|NCT00633464|Primary|Percentage of Participants With Objective Response (OR; Using Response Evaluation Criteria in Solid Tumors [RECIST])|The participant had an OR if her best overall response (BOR) during the study was either a complete response (CR) or a partial response (PR) according to the RECIST as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Confidence interval (CI) was Computed using Clopper-Pearson method.|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until disease progression (maximum participant objective response of 18.3 weeks)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
120818|NCT00633464|Secondary|Time to Response|"Time to response is defined as the time from the date of start of treatment until measurement criteria are first met for PR or CR (whichever is recorded first).~CR: Disappearance of all target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions with reference to the baseline sum LD.~Time to response was estimated using the Kaplan-Meier product-limit method."|Assessed every 6 weeks for first 12 months from randomization thereafter every 3 months until CR or PR (maximum participant time to response of 18.3 weeks.)|Randomized participants with response of CR or PR.||weeks||Full Range|Median
120819|NCT00633464|Secondary|Progression Free Survival (PFS)|"PFS is defined as the time interval from date of randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley.~PD: At least 20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall."|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 17 months)|All randomized participants. Participants who did not progress or die were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
120820|NCT00633399|Secondary|Comparing Scores on HAM-D 17 Baseline Visit to Phase 2 Final Visit at Week 8|This will involve looking at the change in HAM-D 17 scores during phase 2. For HAMD-17 the minimum is 0, the maximum is 52, and greater scores represent more symptoms.|8 weeks|||units on a scale||Standard Deviation|Mean
120821|NCT00633399|Secondary|Remission Rates (HAM-D 17 Scores of Less Than 8) After Treatment Phase 2.|A secondary outcome measure will be remission rates (HAM-D 17 scores of less than 8) after treatment phase 2.. A remitted will be a patient with a final score of 7 or less on the HAMD-17 during phase 2.|8 weeks|||Percentage of patients|||Number
120822|NCT00633399|Primary|The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2|The primary outcome measure will be response rates (50% decrease in HAM-D-17 scores) during phase 2. A responder will be a patient who experiences a 50% or greater decrease in symptoms according to the HAM-D-17 during phase 2.|8 Weeks|||Percentage of patients|||Number
120823|NCT00636220|Secondary|The Effectiveness of MPC and Chembio Oral Fluid Collection Devices||1-3||||||
120824|NCT00636220|Primary|Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity|Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.|1 to 3 days|||samples|||Number
120825|NCT00636207|Primary|Cmax Accumulation Ratio of Montelukast - Multiple Doses|The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol||ratio|||Number
120826|NCT00636207|Primary|AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses|The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.|up to 10 days after first dose of study drug|Per Protocol Population: All participants who complied with the protocol||ratio|||Number
120827|NCT00636207|Primary|t1/2 of Montelukast - Multiple Doses|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Standard Deviation|Mean
120828|NCT00636207|Primary|Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose|Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Standard Deviation|Mean
120829|NCT00636207|Primary|Tmax of Montelukast - Multiple Doses|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Full Range|Median
120830|NCT00636207|Primary|Time to Cmax (Tmax) of Montelukast - Single Dose|Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||hours||Full Range|Median
120831|NCT00636207|Primary|Cmax of Montelukast - Multiple Doses|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL||Standard Deviation|Mean
120832|NCT00636207|Primary|Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose|Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL||Standard Deviation|Mean
120833|NCT00636207|Primary|AUC 0-24hr of Montelukast - Multiple Doses|Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.|Up to 24 hours postdose|Per Protocol Population: All participants who complied with the protocol||ng/mL*hr||Standard Deviation|Mean
120840|NCT00636168|Secondary|Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint|Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.|Baseline up to 2 years from randomization|All randomized patients (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized patients (ITT) with a measurement at the timepoint were considered.||units on a scale||Standard Deviation|Mean
120841|NCT00636168|Primary|Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population|RFS was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A patient who died without reported recurrence was considered to have recurrence on the date of death. For those who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. CT and MRI were mandatory to establish recurrence. Yearly recurrence-free survival rates, eg. at 1 year, defined as the probability that a participant was recurrence-free at 1 year following randomization, were estimated for each treatment group using the Kaplan-Meier product-limit method, along with their corresponding log-log transformed 95% confidence intervals.|Randomization up to Years 1, 2, and 3|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.||Percent Probability||95% Confidence Interval|Number
120842|NCT00636168|Primary|Number of Patients With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence was defined as appearance of one or more new melanoma lesions: local, regional or distant metastasis. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. A patient who died without reported recurrence was considered to have recurred on the date of death. Disease was assessed at randomization and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.||participants|||Number
120843|NCT00636168|Secondary|Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events|P-Y = person-years of exposure. Incidence rate per 100 person-years of exposure (IR/100 P-Y) was calculated as event count * 100 /person-years of exposure. MedDRA Version: 16.1. Duplicate AEs have been eliminated and overlapping and contiguous occurrences of the same event have been collapsed.|Day 1 up to 70 days after last dose or last known alive date for participants still being dosed; up to 5 years|All patients who received at least one dose of ipilimumab or placebo, adjusted for person-years (P-Y) of exposure; P-Y=440.5; P-Y=728.1 for ipilimumab and placebo, respectively.||events/100 person-years of exposure|||Number
120844|NCT00636168|Secondary|Number of Patients With Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population|AEs: Medical Dictionary for Regulatory Activities (MedDRA) version 16.1. irAEs=unknown etiology consistent with an immune phenomenon, considered as causally related to drug. imARs=based on investigator’s assessment of immune-mediated etiology [excluding novel maintenance events (ie, patients with imARs occurring for the first time during maintenance)]. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related (D-R)=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to 70 days after last dose or last known alive date for patients still being dosed; up to 5 years|All patients who received at least one dose of treatment were analyzed. Patients were analyzed in their randomized group provided they received the randomized treatment at least once; those who received incorrect medication for the entire treatment period were analyzed in the group associated with the incorrect medication.||participants|||Number
120845|NCT00636168|Secondary|Number of Participants With Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death. For those participants who have not died, OS was censored at the recorded last non-missing date of contact for which the participant was known to be alive.|date of randomization to date of death or last known alive date with OS data upto 5 years.||04/2018||||
120846|NCT00636168|Secondary|Number of Patients With Distant Metastasis-Free Survival (DMFS)|DMFS was programmatically determined based on the first date of distant metastasis provided by the IRC and was defined as the time between the date of randomization and the date of first distant metastasis or death (whatever the cause), whichever occurred first. A patient who died without reported disease distant metastasis was considered to have distant metastasis on the date of death. For those who remained alive and metastasis-free, DMFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, DMFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. Disease was assessed at baseline (randomization) and every 12 weeks (±2 weeks) for 3 years, then every 24 weeks until documented distant progression.|Date of randomization to date of DMFS, up to 5 years||09/2016||||
120897|NCT00635609|Primary|Successful Outcome According to Investigator's Global Assessment (IGA)|The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks.|baseline and 12 weeks|||participants|||Number
120847|NCT00636168|Primary|Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population|Recurrence free survival (RFS) was programmatically determined based on the disease recurrence data provided by the IRC and was defined as the time between the date of randomization and the date of first recurrence or death (whatever the cause), whichever occurred first. A patient who died without reported recurrence was considered to have recurrence on the date of death. For those patients who remained alive and recurrence-free, RFS was censored on the date of last evaluable post-randomization tumor assessment. For those who remained alive and had no recorded post-randomization tumor assessment, RFS was censored on the day of randomization. Patients with disease at baseline were considered to have an event on the day of randomization. Computerized tomography (CT) and magnetic resonance imaging (MRI) were mandatory to establish recurrence. The primary analysis was event-driven and planned when at least 512 RFS events assessed per IRC were collected.|Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.|All randomized patients (ITT), analyzed in the arm to which they were allocated by randomization were analyzed.||months||95% Confidence Interval|Median
120848|NCT00636155|Secondary|Overall Survival||5 years|All patients who received treatment||months||95% Confidence Interval|Median
120849|NCT00636155|Secondary|Progression Free Survival|Progression is defined as at least one of the following: 1) ≥ 50% increase in the sum of the products of at least two lymph nodes one two consecutive determinations (at least one node must be ≥ 2 cm); appearance of new palpable lymph nodes, 2) ≥ 50% increase in the size of the liver and/or spleen; appearance of palpable hepatomegaly or splenomegaly, which was not previously present, 3) ≥ 50% increase in the absolute number of circulating lymphocytes to at least 5,000/µl or 4)Transformation to a more aggressive histology.|5 years|All patients who received treatment||months||95% Confidence Interval|Median
120850|NCT00636155|Primary|Number of Patients With an Overall Response (Complete Response + Partial Response)|Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months.|every 3 cycles|Patients completing at least 2 cycles of treatment||participants|||Number
120851|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood B2-microglobulin Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||whole blood clearance B2-microglobulin||Standard Error|Mean
120852|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for b2-microglobulin Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||KoA for b2-microglobulin (mL/min)||Standard Error|Mean
120853|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Phosphorus Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||whole blood phosphorus clearance mL/min||Standard Error|Mean
120854|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Phosphorus Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||KoA for Phosphorus (mL/min)||Standard Error|Mean
120855|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on Whole Blood Urea Clearance Between 4 Dialyzers With Different Membrane Packing Densities.||During the third treatment with each dialyzer (one time during each trial period week)|||Whole blood urea clearance (mL/min)||Standard Error|Mean
120856|NCT00636077|Primary|Effect of Increased Dialysate Flow Rate on KoA for Urea Between 4 Dialyzers With Different Membrane Packing Densities.|KoA is a constant that describes the efficiency of a dialyzer in removing urea. KoA is determined by surface area of the membrane, the thickness of the membrane and pore size.|During the third treatment with each dialyzer (one time during each trial period week)|||KoA for urea (mL/min)||Standard Error|Mean
120857|NCT00635882|Other Pre-specified|Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)||Baseline|||ppb||Standard Deviation|Mean
120858|NCT00635882|Secondary|Change From Baseline in PM PEF at Days 1-15||Baseline and Days 1-15|All randomized participants||liters/minute||Standard Deviation|Mean
120859|NCT00635882|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15||Baseline and Days 2-15|All randomized participants||liters/minute||Standard Deviation|Mean
120860|NCT00635882|Secondary|Change From Baseline in PM Total Asthma Symptom Score at Days 1-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 1-15|All randomized participants||units on a scale||Standard Deviation|Mean
120861|NCT00635882|Secondary|Change From Baseline in AM Total Asthma Symptom Score at Days 2-15|Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.|Baseline and Days 2-15|All randomized participants||units on a scale||Standard Deviation|Mean
120862|NCT00635882|Secondary|Mean Change From Baseline to Day 15 of Mannitol Challenge|Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).|Baseline to Day 15|All randomized participants||milligrams||Standard Deviation|Mean
120863|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)||Baseline to Day 14|All randomized participants||percentage of Sputum Eosinophil Count||Standard Deviation|Mean
120864|NCT00635882|Secondary|Mean Percent Change From Baseline to Day 7 in eNO Ppb||Baseline to Day 7|All Randomized Participants||percentage of eNO||Standard Deviation|Mean
120866|NCT00635830|Primary|Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination|||Participants|||Number
120867|NCT00635817|Post-Hoc|Percentage of Participants With a Decrease From Baseline in the Ratio of Bone Age to Chronological Age at Month 6 Compared to Baseline|The ratio at baseline or Month 6 was calculated as bone age at baseline or Month 6/chronological age at baseline or Month 6. The percentage of participants with a decrease in the ratio was calculated as a simple percentage for each dose group. Observed data were used with no imputation for missing data. The baseline time frame was increased from the secondary outcome in this analysis to include all participants with a bone age radiograph at screening. This analysis was performed after the clinical study report was completed & is included to match the FDA package insert.|Baseline to Month 6|The baseline time frame was increased from the secondary outcome to this analysis to include all participants with a bone age radiograph at screening. This analysis was performed post hoc to match the FDA package insert.||Percentage of Participants|||Number
120868|NCT00635817|Post-Hoc|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (< 4 mIU/mL) From Month 2 Through Month 6 (Simple Percentage With Binomial Exact Confidence Intervals)|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a GnRHa stimulation test at Mo 2, 3, and 6. A simple percentage and binomial exact confidence intervals were used in this analysis. Participants who withdrew with luteinizing hormone that remained suppressed were counted as a success. This analysis was performed after the clinical study report was completed and is included to match the FDA package insert.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
120869|NCT00635817|Secondary|Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6|The ratio at Month 6 was calculated as (bone age at Month 6 - bone age at baseline)/(chronological age at Month 6 - chronological age at baseline). Observed data were used with no imputation for missing data. Baseline bone-age radiograph was performed at or within 3 months of the Screening Visit.|Baseline to Month 6|Participants must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Ratio||Standard Deviation|Mean
120870|NCT00635817|Secondary|Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6|The growth rate at baseline was the growth rate during the last year before the start of treatment and was calculated with the measurement closest to Day -336 (before Day -30) and the measurement up to Day 1. Growth rate at Month 6 was defined as the ratio of the change in height from Day 1 to the change in chronological age, with an approximate 6-month interval between the 2 height measurements. Observed data were used with no imputation for missing data.|Baseline and Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||cm/year||Standard Deviation|Mean
120871|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6|Percentage of participants with suppression of genital development and testicular volume, out of the number of boys with pubertal staging of genital development or testicular volume (n/N%). Only boys are analyzed in this outcome measure. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
120872|NCT00635817|Secondary|Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6|Percentage of participants with suppression of breast development, out of the number of girls with pubertal staging of breast development (n/N%). Only girls are analyzed in this outcome measure. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.|Month 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
120873|NCT00635817|Secondary|Peak-stimulated Luteinizing Hormone Concentration by Visit|Observed data were used with no imputation for missing data.|Baseline, Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||mIU/mL||Standard Deviation|Mean
120874|NCT00635817|Secondary|Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit|Percentage of participants with suppression of testosterone, out of the number of boys with at least 1 testosterone measurement at each visit (n/N%). Only boys are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
120875|NCT00635817|Secondary|Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit|Percentage of participants with suppression of estradiol, out of the number of girls with at least 1 estradiol measurement at each visit (n/N%). Only girls are analyzed in this outcome measure. Observed data were used with no imputation for missing data.|Month 1, 2, 3 and 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
120876|NCT00635817|Primary|Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6|Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone >= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.|Month 2 through 6|Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.||Percentage of Participants||95% Confidence Interval|Number
120877|NCT00635804|Secondary|Maximum HCV Viral Load Change From Baseline Over Study Following MK-3281 Dosing For 7 Days|For evaluation of MK-3281 antiviral activity, the maximum reduction in HCV ribonucleic acid (RNA) levels over the course of the study was assessed by MK-3281 dose group in HCV+ participants and the mean maximum viral load reduction was summarized. HCV RNA levels were measured at predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours postdose on Day 1 and Day 7; pre-morning (AM) and pre-evening (PM) dose Day 2; and pre AM dose Days 3-6. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing, and change from baseline (difference) was calculated at each time point. The response for that participant was defined as: − (postbaseline time point − baseline) at the time point with the lowest HCV RNA level.|Baseline (pre-dose Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7|Treated HCV+ participants in Part II with available HCV RNA data. 800 mg dose group contained members of Panels E and F. No healthy participants from Part 1 (Panels A, B, C, or D) were assessed for this outcome measure.||log(IU/ml)||95% Confidence Interval|Mean
120878|NCT00635804|Secondary|C12hr Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 C12hr accumulation ratio was calculated for HCV+ participants and healthy participants. C12hr accumulation ratio calculated for healthy participants as Day 10 C12hr / Day 1 C12hr. C12hr accumulation ratio calculated for HCV+ participants as Day 7 C12hr / Day 1 C12hr.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||ratio||90% Confidence Interval|Geometric Mean
120879|NCT00635804|Secondary|Cmax Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 Cmax accumulation ratio was calculated for HCV+ participants and healthy participants. Cmax accumulation ratio calculated for healthy participants as Day 10 Cmax / Day 1 Cmax. Cmax accumulation ratio calculated for HCV+ participants as Day 7 Cmax / Day 1 Cmax.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||ratio||90% Confidence Interval|Geometric Mean
120880|NCT00635804|Secondary|AUC (0-12hr) Accumulation Ratio of MK-3281|Blood samples were obtained from participants and the MK-3281 AUC(0-12hr) accumulation ratio was calculated for HCV+ participants and healthy participants. AUC(0-12hr) accumulation ratio calculated for healthy participants as Day 10 AUC (0-12hr) / Day 1 AUC (0-12hr). AUC(0-12hr) accumulation ratio calculated for HCV+ participants as Day 7 AUC (0-12hr) / Day 1 AUC (0-12hr).|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||ratio||90% Confidence Interval|Geometric Mean
120881|NCT00635804|Secondary|Apparent Half-Life (t ½) of MK-3281|Blood samples were obtained from participants and MK-3281 apparent t ½ was calculated at Day 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay. Harmonic mean t ½ and pseudo standard deviation were reported.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose on Day 7 (HCV+ participants) or Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||hour||Standard Deviation|Mean
120882|NCT00635804|Secondary|Time To Reach Cmax (Tmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Tmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||hour||Full Range|Median
120883|NCT00635804|Secondary|12-Hour Concentration of MK-3281 in Plasma (C12hr)|Blood samples were obtained from participants and MK-3281 plasma C12hr was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||μM||Geometric Coefficient of Variation|Geometric Mean
120884|NCT00635804|Secondary|Maximum Plasma Concentration (Cmax) of MK-3281|Blood samples were obtained from participants and MK-3281 Cmax was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||μM||Geometric Coefficient of Variation|Geometric Mean
120898|NCT00635570|Post-Hoc|Continuation Rate|Rate of intention to continue the contraceptive method at 6 months|at 6 month (3 month after the end of the study period)|At 6 months, four from the contraceptive vaginal ring group and three from the oral contraceptive pill group did not complete the 6-month survey and thus were excluded from analysis.||Percentage of Participants|||Number
120885|NCT00635804|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time 12 Hours (AUC[0-12]) of MK-3281|Blood samples were obtained from participants and MK-3281 AUC(0-12) was calculated at Days 1 and 7 (for HCV+ participants) or Day 10 (for healthy participants) using the MK-3281 assay.|Predose daily on Days 2-9 (for healthy participants) and Days 2-6 (for HCV+ participants), and predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 1, Day 7 (HCV+ participants), and Day 10 (healthy participants)|All Treated Participants with available PK data. Participants in the Placebo group did not receive MK-3281 and therefore did not have PK data reported.||μM·hr||Geometric Coefficient of Variation|Geometric Mean
120886|NCT00635804|Primary|Number of Participants Who Discontinued Study Medication Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants||participants|||Number
120887|NCT00635804|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Up to 14 days after the last dose of study drug (up to 24 days maximum)|All Treated Participants||participants|||Number
120888|NCT00635700|Secondary|Improvement SOPS Total Score||8 weeks||||||
120889|NCT00635700|Primary|Conversion to Psychosis|Conversion to psychosis according to the SIPS require psychotic symptom severity ratings in the frankly psychotic range, along with meeting persistence or urgency criteria.|6 months|In another case assigned to active ziprasidone, ratings conducted at a follow-up conversion visit suggested retrospectively that the patient had been already psychotic prior to enrollment. The study’s blinded DSMB was consulted, and in a split 4-2 vote recommended retaining the patient as randomized in the primary analysis.||participants|||Number
120890|NCT00635661|Primary|Stroke Rehabilitation Assessment of Movement (STREAM)|The STREAM measures quality of movements in the arm and leg, and the quality of mobility during important functional tasks, such as walking 10 feet. There are 10 items for each of the 3 assessments (arm, leg and mobility), resulting in a total of 30 items. Each item is rated on a scale of 0 = unable to perform, to 2 or 3 = normal movement. Ratings on the 30 items are added together for a total score which is divided by the total number of items resulting in a percentage score: minimum=0, maximum=100, range=100 The score reported is mean +/- standard deviation of discharge STREAM scores.|4 weeks|34 participants were enrolled, 4 participants were dropped from the study resulting in 30 participants providing data for analysis.||units on a scale||Standard Deviation|Mean
120891|NCT00635648|Secondary|Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis|"Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions.~Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response."|First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|Of the 63 enrolled participants, one participant with invasive candidiasis who withdrew consent before completing the efficacy assessment was not included in the efficacy analyses.||Participants|||Number
120892|NCT00635648|Secondary|Number of Participants Who Discontinued Due to a Drug-related Adverse Event|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|||Participants|||Number
120893|NCT00635648|Secondary|Number of Participants With One or More Drug-related Adverse Events|A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|||Participants|||Number
120894|NCT00635648|Primary|Number of Participants With One or More Drug-related Serious Adverse Events|"A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention.~A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile."|First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)|||Participants|||Number
120895|NCT00635609|Primary|Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks|intention to treat (ITT)||acne lesion count||Standard Deviation|Mean
120896|NCT00635609|Secondary|Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks|Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated.|baseline and 12 weeks|||Acne lesion count||Standard Deviation|Mean
120901|NCT00635570|Primary|Adherence Rate (Rate of Perfect Method Use)|"Perfect use was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles"|For the first 3 months|||Percentage of Participants|||Number
120902|NCT00635492|Secondary|Percentage of Patients Hospitalized Between Baseline and 24 Months|Percentage of Patients Hospitalized Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
120903|NCT00635492|Secondary|Number of Contacts With Health Care Providers Between Baseline and 24 Months|Number of contacts with Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||number of contacts||Standard Deviation|Mean
120904|NCT00635492|Secondary|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
120905|NCT00635492|Secondary|Factors Associated With Treatment Change in Exenatide BID Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||hazard ratio||95% Confidence Interval|Number
120906|NCT00635492|Secondary|Factors Associated With Treatment Change in Insulin Cohort|Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||hazard ratio||95% Confidence Interval|Number
120907|NCT00635492|Secondary|Reasons for Discontinuation of Baseline Regimen|Reasons for Discontinuation of Baseline Regimen|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||number of patients|||Number
120908|NCT00635492|Secondary|Incidence of Hypoglycemia Between Baseline and 24 Months|Incidence of Hypoglycemia between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
120909|NCT00635492|Secondary|Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months|Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months|Baseline to Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
120910|NCT00635492|Secondary|Changes in Weight From Baseline to Month 24|Changes in Weight From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||kg||Standard Deviation|Mean
120911|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
120912|NCT00635492|Secondary|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24|Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis|Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of patients|||Number
120913|NCT00635492|Secondary|Changes in HbA1c From Baseline to Month 24|Changes in HbA1c From Baseline to Month 24|Baseline, Month 24|"Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.~All patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population."||percentage of total hemoglobin||Standard Deviation|Mean
120957|NCT00635102|Secondary|Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure distractibility - (A-Prime score range 0 minimum - 1 maximum - the higher number the better the performance)|30 minutes|||units on a scale||Standard Deviation|Mean
120914|NCT00635492|Secondary|Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline|Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||mmol/L||Standard Deviation|Mean
120915|NCT00635492|Secondary|Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline|Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||participants|||Number
120916|NCT00635492|Secondary|Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline|Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|4 weeks prior to Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||tests/week||Standard Deviation|Mean
120917|NCT00635492|Secondary|Higher Random Glucose Associated With Treatment Choice at Baseline|Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|6 months prior to Baseline|||mmol/L||Standard Deviation|Mean
120918|NCT00635492|Secondary|Disinhibited Eating Associated With Treatment Choice at Baseline|Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, provided the specific data (DHP-18 subscale on disinhibited eating) and had a start date provided were included in the analyses.||units on a scale||Standard Deviation|Mean
120919|NCT00635492|Secondary|Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||years||Standard Deviation|Mean
120920|NCT00635492|Secondary|Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline|Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||percent of hemoglobin||Standard Deviation|Mean
120921|NCT00635492|Secondary|Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).|Baseline|All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.||kg/m^2||Standard Deviation|Mean
120942|NCT00635349|Secondary|Number of Participants With Pain Relief|Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||participants|||Number
120958|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|120 minutes|||units on a scale||Standard Deviation|Mean
120922|NCT00635492|Primary|Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.|"The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.~Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.~Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:~Insulin:~Addition of a new medication for the treatment of type 2 diabetes~A change in the number of times insulin is administered per day~Discontinuation of any insulin initiated at baseline~Substitution of a human insulin for an analogue insulin or vice-versa.~Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.~Exenatide:~Addition of a new medication for the treatment of type 2 diabetes~Discontinuation of exenatide."|Month 24|All patients who provided consent to release information and who fulfil the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.||probability (%)||95% Confidence Interval|Number
120923|NCT00635479|Secondary|Nursing Time Cost for Dressing Changes||until wound is healed||||||
120924|NCT00635479|Secondary|Dressing Supply Costs||until wound healed||||||
120925|NCT00635479|Secondary|Hospital Length of Stay||until discharge from acute care||||||
120926|NCT00635479|Secondary|Wound Drainage||until wound healed||||||
120927|NCT00635479|Primary|Wound Infections||until wound healed|||participants|||Number
120928|NCT00635427|Secondary|Percentage Change From Baseline to 24 Months in Normalized Spleen Volume for Each Treatment Group||Baseline to 24 months|||Precent (%) change||95% Confidence Interval|Mean
120929|NCT00635427|Secondary|Change From Baseline to 24 Months in Normalized Liver Volume for Each Treatment Group||Baseline to 24 months|||% Body weight||95% Confidence Interval|Mean
120930|NCT00635427|Secondary|Change From Baseline to 24 Months in Platelet Counts for Each Treatment Group||Baseline to 24 months|||(10^9/L)||95% Confidence Interval|Mean
120931|NCT00635427|Secondary|Change From Baseline to 24 Months in Hemoglobin Concentration for Each Treatment Group||Baseline to 24 months|||(g/dL)||95% Confidence Interval|Mean
120932|NCT00635427|Primary|Overall Summary of Treatment Emergent Adverse Events|Safety was evaluated by an analysis of adverse events (AEs), concomitant medication use, clinical laboratory tests, vital signs during the infusion of study drug, physical examination, and the development of anti-velaglucerase alfa. No formal comparisons or statistical tests were applied for the safety analyses, including for differences between the groups.|Baseline to termination of study|All participants who received at least 1 infusion (full or partial) of study drug were evaluated for safety (ie, were included in the safety population). There were 95 participants in the safety population.||Participants|||Number
120933|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being “very unsatisfied,” 2 “unsatisfied”, 3 “neutral,” 4 “satisfied,” and 5 “very satisfied.” For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|12 months after cesarean delivery|Analysis only done on subjects completing 12-month visit||participants|||Number
120934|NCT00635362|Secondary|Satisfaction With LNG-IUS|"We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being “very unsatisfied,” 2 “unsatisfied”, 3 “neutral,” 4 “satisfied,” and 5 “very satisfied.” For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question."|6 months after cesarean delivery|Analysis only done on subject completing six-month visit||participants|||Number
120935|NCT00635362|Secondary|Perforation Rates||12 months after cesarean delivery|||participants|||Number
120936|NCT00635362|Secondary|Rates of Expulsion of the LNG-IUS||12 months after cesarean delivery|||participants|||Number
120937|NCT00635362|Primary|Use of the LNG-IUS for Contraception||12 months after cesarean delivery|||participants|||Number
120938|NCT00635349|Secondary|Number of Participants With Categorical Tenderness|Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||participants|||Number
120939|NCT00635349|Secondary|Number of Participants With Categorical Swelling|Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).|Day 29, Day 57 and Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.||participants|||Number
120940|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Investigator|Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure||participants|||Number
120941|NCT00635349|Secondary|Number of Participants With Overall Assessment on Study Drug by Participants|Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.|Day 85|FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure||participants|||Number
120982|NCT00635102|Secondary|Visual Analog Scales (VAS) - Baseline|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|Baseline|||units on a scale||Standard Deviation|Mean
120943|NCT00635349|Secondary|Change From Day 29 in Pain Intensity Score at Day 85|Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
120944|NCT00635349|Primary|Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85|The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Day 29 and Day 85|Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied.||units on a scale||Standard Deviation|Mean
120945|NCT00635154|Secondary|Duration of Response|Duration of response is defined for all evaluable participants (receiving Anakinra alone or in combination with Dexamethasone) who have achieved an objective response as the date at which the participants status was first noted to be MR or better to the date progression is documented or the date of last follow-up.|From first documentation of response to progression or last follow-up (up to 5 years)|Participants (receiving Anakinra alone or in combination with Dexamethasone) who achieved a MR or better were analyzed.||months||95% Confidence Interval|Median
120946|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|every cycle during treatment (up to 5 years)|Only participants who received Anakinra with low or high dose dexamethasone were analyzed.||participants|||Number
120947|NCT00635154|Secondary|Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone|"PFS was defined as the time from registration to progression or death due to any cause.~Progression is defined the same as outcome measure #3."|Time from registration to progression or death (up to 5 years)|PFS results were published in Mayo Clin Proc, Feb 2009. 47 patients were analyzed for this publication.||months||95% Confidence Interval|Median
120948|NCT00635154|Secondary|Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone.|Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.|Duration of treatment (up to 5 years)|||participants|||Number
120949|NCT00635154|Secondary|Number of Patients Who Are Progression-free and Alive at 6 Months|"Disease stability was assessed by evaluating the proportion of participants who are progression free (and alive) at 6 months.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response:~Serum M-component (absolute increase >=1.0 g/dL)~Urine M-component (absolute increase >=200 mg/24 hours)~An increase of 50% above the lowest remission value in bone marrow plasmacytosis (absolute increase 25% bone marrow plasma cells)~Development of new bone lesions or soft tissue plasmacytomas."|at 6 months|||participants|||Number
120950|NCT00635154|Secondary|Number of Patients With Response to Treatment With Dexamethasone and Anakinra|"Response on 2 consecutive months during active treatment with anakinra alone or in combination with dexamethasone.~Response criteria is the same as in Primary Outcome Measure."|During Active treatment (up to 5 years)|Only participants who received Anakinra with dexamethasone were analyzed.||participants|||Number
120951|NCT00635154|Primary|Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone|"Response Definitions:~Complete Response(CR):disappearance of M-Protein from serum & urine and immunofixation, <5% bone marrow(BM) plasma cells & disappearance of soft tissue plasmacytomas(STP);~Very Good Partial Response(VGPR):>=90% decrease in serum M-Protein, Urine M-protein <100 mg/24 hours, <=5% BM plasma cells, disappearance of STP;~Partial response(PR):>=50% reduction in serum M-protein, >=90% decrease in Urine M-protein or <200 mg/24 hours & >=50% decrease in STP;~Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein & 25-49% decrease in STP"|6 months|Participants who met the eligibility criteria, signed the consent form and have began treatment were considered evaluable.||participants|||Number
120952|NCT00635102|Secondary|Hopkins Verbal Learning Task - Delay Recall - 90 Minutes|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (delay recall - 30 minutes after Trials 1-3 were given) (0 No words recalled - 12 all words recalled)|90 minutes|||units on a scale||Standard Deviation|Mean
120953|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 3|||units on a scale||Standard Deviation|Mean
120954|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 2|||units on a scale||Standard Deviation|Mean
120955|NCT00635102|Secondary|Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1|Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)|60 minutes - Trial 1|||units on a scale||Standard Deviation|Mean
120956|NCT00635102|Secondary|Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes|gordon diagnostic system is a continuous performance task (CPT) to measure Vigilance - (A-Prime score range 0 minimum - 1 maximum - The higher number the better the performance)|30 minutes|||units on a scale||Standard Deviation|Mean
120959|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes|||units on a scale||Standard Deviation|Mean
120960|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|30 minutes|||units on a scale||Standard Deviation|Mean
120961|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
120962|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline|Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)|Baseline|||units on a scale||Standard Deviation|Mean
120963|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|120 minutes|||units on a scale||Standard Deviation|Mean
120964|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes|||units on a scale||Standard Deviation|Mean
120965|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|30 minutes|||units on a scale||Standard Deviation|Mean
120966|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
120967|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline|Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)|Baseline|||units on a scale||Standard Deviation|Mean
120968|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|120 minutes|||units on a scale||Standard Deviation|Mean
120969|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes|||units on a scale||Standard Deviation|Mean
120970|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|30 minutes|||units on a scale||Standard Deviation|Mean
120971|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
120972|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline|Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)|Baseline|||units on a scale||Standard Deviation|Mean
120973|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|120 minutes|||units on a scale||Standard Deviation|Mean
120974|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes|||units on a scale||Standard Deviation|Mean
120975|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|30 minutes|||units on a scale||Standard Deviation|Mean
120976|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
120977|NCT00635102|Secondary|Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline|Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol)|Baseline|||units on a scale||Standard Deviation|Mean
120978|NCT00635102|Secondary|Visual Analog Scales (VAS) - 120 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|120 minutes|||units on a scale||Standard Deviation|Mean
120979|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes|||units on a scale||Standard Deviation|Mean
120980|NCT00635102|Secondary|Visual Analog Scales (VAS) - 30 Minutes|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|30 minutes|||units on a scale||Standard Deviation|Mean
120981|NCT00635102|Secondary|Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion|Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)|60 minutes prior to Glycine infusion|||units on a scale||Standard Deviation|Mean
120983|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|120 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
120984|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
120985|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|30 minutes|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
120986|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|60 minutes prior to Glycine infusion|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
120987|NCT00635102|Secondary|Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol|Baseline|Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol||units on a scale||Standard Deviation|Mean
120988|NCT00635102|Secondary|Number of Drinks Felt Consumed at 120 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|120 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||Number of Drinks Felt Consumed||Standard Deviation|Mean
120989|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||Number of Drinks Felt Consumed||Standard Deviation|Mean
120990|NCT00635102|Secondary|Number of Drinks Felt Consumed at 30 Minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|30 minutes|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||Number of Drinks Felt Consumed||Standard Deviation|Mean
120991|NCT00635102|Secondary|Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.|60 minutes prior to Glycine infusion|The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed.||drinks felt consumed||Standard Deviation|Mean
120992|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 120 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|120 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
120993|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
120994|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 30 Minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|30 minutes|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
120995|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|60 minutes prior to Glycine infusion|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
120996|NCT00635102|Primary|Visual Analog Scales of Similarity to Alcohol - Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol|Baseline|Visual Analog Scales of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol –7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol||units on a scale||Standard Deviation|Mean
120997|NCT00635050|Secondary|Assess Toxicities of Regimen Including Hand Foot Syndrome|patients who receive any treatment drugs will be included for toxicity evaluation. Adverse events will be summarized with frequencies and proportions of study participants exhibiting adverse events. The severity of adverse events (none, mild, moderate, severe) and their relationship to the product will be presented.|Baseline, every 2 weeks during treatment, and at completion of therapy. Every 3 weeks during postoperative Avastin|||participants|||Number
120998|NCT00635050|Secondary|Calculate Progression Free Survival|Progression free survival (PFS) will be defined as survival without local recurrence of breast cancer and without the development of distant metastasis. Death from any cause will be included as an event. The Kaplan-Meier nonparametric method will be used to estimate progression free survival.|5 years|operative specimens after treatment of participants||participants|||Number
120999|NCT00635050|Secondary|Number of Participant With Clinical or Subclinical Cardiotoxicity|Left ventricular ejection fraction (LVEF) measurements and clinical examination at baseline and at end of therapy will be used.|Prior to treatment and at completion of chemotherapy|||participants|||Number
121000|NCT00635050|Primary|Rate of Achievement of Pathological Complete Response (pCR)|Results of the pathologic evaluation of the surgical specimen(s) from operation (segmental or total mastectomy) will be used to report the overall complete pathological response rate. Criteria used were those described by Kaufmann et al, Journal of Clinical Oncology 2003; 21(13):2600-2608. The definition of pCR used from this source was absence of invasive cancer in both resected breast tissue and in resected axillary nodes.|After completion of at least 8 of the 9 chemotherapy doses and operation.|Intention to treat, i.e., all participants entered were included in the analysis.||pathology specimens from participants|||Number
121001|NCT00635024|Secondary|Number of Participants With Severe Non-hematological Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)|every month during treatment, up to 12 months|||participants|||Number
121002|NCT00635024|Secondary|Duration of Response (DOR)|DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.|up to 2 years|All patients are non-evaluable - no patients responded to treatment.|||||
121003|NCT00635024|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~Bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|up to 2 years|||months||95% Confidence Interval|Median
121004|NCT00635024|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|up to 2 years|||months||95% Confidence Interval|Median
121005|NCT00635024|Primary|Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.~Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 months|One participant was evaluable for the primary endpoint.||participants|||Number
121006|NCT00634933|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||percentage of participants|||Number
121007|NCT00634933|Secondary|Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score|WPAI-RA consisted of 6 items, a binary question on current employment, 3 questions on hours of work and work-loss, and 2 questions based on 0-10 point scale to judge how RA affects productivity at work and outside of work (0 = no effect on work and 10 = completely prevented from working). Four scores are derived: percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health and percent activity impairment due to health. Total possible score range: 0 to 100, where 0 = no impairment and 100 = completely impaired.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
121008|NCT00634933|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
121009|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
121010|NCT00634933|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
121034|NCT00634920|Secondary|Time to First Malignancy|This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Months||Standard Error|Mean
121011|NCT00634933|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24, 36, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
121012|NCT00634933|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's general health visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
121013|NCT00634933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The overall disability index computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
121014|NCT00634933|Secondary|General Health Visual Analog Scale (VAS)|"100 mm line (VAS) marked by participant. Participants were asked, How do you feel concerning your arthritis? Total possible score range, 0 mm = very well to 100 mm = extremely bad."|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
121015|NCT00634933|Secondary|Patient Global Assessment (PtGA) of Disease Activity|Measured using a 0-10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
121016|NCT00634933|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 10 point scale, where 0 = no disease activity and 10 = extreme disease activity.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||units on a scale||Standard Deviation|Mean
121017|NCT00634933|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||mm||Standard Deviation|Mean
121018|NCT00634933|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Data was not analyzed because development of TRU-015 was discontinued as results of primary analysis did not meet the predefined efficacy criteria.|||||
121019|NCT00634933|Secondary|Number of Swollen Joints|The number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||swollen joints||Standard Deviation|Mean
121020|NCT00634933|Secondary|Number of Tender Joints|The number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||tender joints||Standard Deviation|Mean
121021|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||percentage of participants|||Number
121048|NCT00634647|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed of list of adverse events, see the adverse event module.|6/4/08/ to 4/1/12|||Participants|||Number
121022|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 20 were not analyzed because of early termination of the study.||percentage of participants|||Number
121023|NCT00634933|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (HAQ-DI); and CRP.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|mITT population included all randomized participants who received any portion of test article. LOCF method was used to impute missing values. Data for time points after Week 24 were not analyzed because of early termination of the study.||percentage of participants|||Number
121024|NCT00634933|Primary|Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all randomized participants who received any portion of test article. Last observation carried forward (LOCF) method was used to impute missing values.||percentage of participants|||Number
121025|NCT00634920|Secondary|Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D|Health-related QoL was assessed using the EQ-5D questionnaire. The EQ-5D self-report questionnaire consists of the EQ-5D descriptive system that measures health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/moderate problems/severe problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-1, in which higher scores reflect better health status.|Before randomization, Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||scores on a scale||Standard Deviation|Mean
121026|NCT00634920|Secondary|Percentage of Participants Who Had Donor Specific Antibodies (DSA)|Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
121027|NCT00634920|Secondary|Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))|Proteinuria is when a large amount of protein, that should remain circulating in a person’s blood, is “spilled” into their urine and eliminated from the body.|Months 12, 24, 36|The safety population (SAF) consists of all patients in whom TX was performed and who were randomized and treated with at least one dose of randomized treatment.||mg/mmol||Standard Deviation|Mean
121028|NCT00634920|Secondary|Percentage of Participants on Antihypertensive Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
121029|NCT00634920|Secondary|Number of Antihypertensive Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Number of antihypertensive dugs||Standard Deviation|Mean
121030|NCT00634920|Secondary|Percentage of Participants on Lipid-lowering Drugs||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
121031|NCT00634920|Secondary|Number of Lipid-lowering Drugs Taken||Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Number of lipid-lowering drugs||Standard Deviation|Mean
121032|NCT00634920|Secondary|Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides|Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mmol/L||Standard Deviation|Mean
121033|NCT00634920|Secondary|Lipid Profile for Apolipoprotein|Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||g/L||Standard Deviation|Mean
121178|NCT00633750|Secondary|Average Post-treatment Plasma Level of Erlotinib Hydrochloride|Post-treatment plasma level in µmol/L of erlotinib hydrochloride|After last dose of Tarceva, at 5-14 days, and before surgery|Participants with blood taken within 24 hours of last dose of erlotinib and before surgery||µmol/L||Standard Deviation|Mean
121035|NCT00634920|Secondary|Percentage of Participants With Treatment Failures|Treatment failure was defined as graft loss or death.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
121036|NCT00634920|Secondary|Time to Treatment Failure|Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Days||Standard Error|Mean
121037|NCT00634920|Secondary|Percentage of Participants With Graft Loss or Death|The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event).|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
121038|NCT00634920|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)|A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.|Months 12, 24, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
121039|NCT00634920|Secondary|Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)|Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space)|Month 12, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||Percentage of participants|||Number
121040|NCT00634920|Secondary|Progression of Measured Glomerular Filtration Rate|Change in renal progression measured by mean mGFR from week 7 to Month 36|Week 7, Week 52, Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mL/min/1.73m^2||Standard Deviation|Mean
121041|NCT00634920|Secondary|Calculated Glomerular Filtration Rate|The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points.|Months 12, 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mL/min/1.73m^2||Standard Deviation|Mean
121042|NCT00634920|Secondary|Measured Glomerular Filtration Rate|Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 36|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). Patients who did not provide mGFR assessment at M36 visit were excluded from the analysis.||mL/min/1.73m^2||Standard Deviation|Mean
121043|NCT00634920|Primary|Measured Glomerular Filtration Rate|To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.|Month 12|The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).||mL/min/1.73m^2||Standard Deviation|Mean
121044|NCT00634842|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|"Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:~If subject was unable to treat himself: Major incidence.~If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.~If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only."|weeks 0-20|The safety population consists of all subjects exposed to study drug.||number of events|||Number
121045|NCT00634842|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline|Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20|week -2, week 20|The intent-to-treat (ITT), LOCF (last observation carried forward) population. One Subject in 70-90 group, however, had a missing baseline value, therefore, no change from baseline could be calculated.||percentage point change||Standard Error|Least Squares Mean
121046|NCT00634842|Secondary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%|Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)||percentage of participants|||Number
121047|NCT00634842|Primary|Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%|Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment|week 20|The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)||percentage of participants|||Number
121049|NCT00634647|Primary|Progression Free Survival.|Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|15 months|21 out of 24 participants was analyzed because three patients were taken off study before progression.||Months||95% Confidence Interval|Median
121050|NCT00634621|Secondary|Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level.|The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.|Day 0 (Post contrast administration)|The number of confirmed bladder cancer was 219 identified by the standard of truth methods using the White-light cystoscopy and blue-light cystoscopy technique.||Percentage of confirmed Lesions||95% Confidence Interval|Number
121051|NCT00634621|Primary|Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy.|Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.|Day 0 (Post contrast administration)|Number of True-positive lesions according to histology was 621 and broken out into various tumor stages. The Tumor stage distribution of true-positive bladder tumor lesions and their detection by White-light Cystoscopy (WLC) and/or Blue-light Cystoscopy (BLC).||Number of lesions|||Number
121052|NCT00634582|Primary|Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer||16 weeks|This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.|||||
121053|NCT00634569|Secondary|Number of Adverse Events|Total Number of Adverse Events|12 months|||All Adverse Events|||Number
121054|NCT00634569|Secondary|Number of Days on Antibiotics (Prophylactic and Therapeutic).|Median Combined number of days on prophylactic and therapeutic antibiotics|12 months|||Days||Standard Deviation|Median
121055|NCT00634569|Secondary|Number of Infectious Episodes Per Year|Mean Number of infectious episodes per subject/year|12 months|||Infectious episodes||Standard Deviation|Mean
121056|NCT00634569|Secondary|Other Infections Documented by Fever and Physical Exam or Positive Radiograph.||12 months|||Number of other infections||Standard Deviation|Mean
121057|NCT00634569|Secondary|Number of Visits to Physician/ER Room for Acute Problems|Mean Number of visits to physician/ER room for acute problems|12 months|||Visits||Standard Deviation|Mean
121058|NCT00634569|Secondary|Days of Hospitalization Per Year|Mean Days of hospitalization per subject/year|12 months|||Days||Standard Deviation|Mean
121059|NCT00634569|Secondary|Days of School/Usual Activities Missed Per Year|Mean Days of school/usual activities missed per subject/year|12 months|||Days||Standard Deviation|Mean
121060|NCT00634569|Primary|Serious Bacterial Infections.|Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis|12 months|||Total serious bacterial infections|||Number
121061|NCT00634543|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 43|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health and mental health. Physical health includes physical functioning, role limitations due to physical health, pain and general health. Mantal health includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for at given time point.||Units on a scale||Standard Deviation|Mean
121062|NCT00634543|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43|The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Pain severity score is caculated by sum of all severity items (pain worst, pain least, pain average and pain now) divided by pain now. Total score for pain severity ranges from 0=no pain to 10=extreme pain. Pain interference score was calculated by sum of all interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) score. Total score for pain interference ranges from 0=no interference to 70= interferes completely.|Baseline and Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here 'n' signifies number of participants who were evaluated for this outcome measure at a particular time point.||Units on a scale||Standard Deviation|Mean
121063|NCT00634543|Secondary|Overall Assessment of Study Medication by Investigator|Overall assessment of study medication was done by Investigator. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.||Percentage of participants|||Number
121064|NCT00634543|Secondary|Overall Assessment of Study Medication by Participants|Overall assessment of study medication was done by participants. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good.|Day 43|FAS included all randomly assigned participants who met the eligibility criteria and had at least 1 post-baseline efficacy assessment data. Here ‘N’ signifies number of participants who were evaluated for this outcome measure.||Percentage of participants|||Number
121065|NCT00634543|Secondary|Percentage of Participants With Pain Relief|Pain relief was assessed on a scale ranging from -1 to 4, where -1=became worse, 0=no change, 1=relieved a little, 2=relieved moderately, 3=relieved a lot and 4=completely resolved.|Day 15, Day 29 and Day 43|FAS included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.||Percentage of Participants|||Number
121066|NCT00634543|Primary|Change From Baseline in Pain Intensity Score at Day 43|Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.|Baseline and Day 43|Full analysis set (FAS) included all randomly assigned participants who met the eligiblility criteria and had at least 1 post-baseline efficacy assessment data. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
121067|NCT00634504|Primary|Pharmacokinetics (PK) of Leucovorin|Geometric mean 6S-leucovorin area under the curve|3 hours post LV administration|||micromol x hour/L||95% Confidence Interval|Geometric Mean
121068|NCT00633594|Secondary|Overall Survival of Previously Treated and Previously Untreated Participants|"Defined as the date of study entry to the date of death.~Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment||months||95% Confidence Interval|Median
121069|NCT00633594|Secondary|Overall Survival of Phase I and Phase II Participants|"Defined as the date of study entry to the date of death.~Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification"|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|all participants that received study treatment||months||95% Confidence Interval|Median
121070|NCT00633594|Secondary|Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.~Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment||months||95% Confidence Interval|Median
121071|NCT00633594|Secondary|Progression Free Survival (PFS) of Phase I and Phase II Participants|"Defined as the time from entry onto study until lymphoma progression or death from any cause.~Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression|All participants that received study treatment||months||95% Confidence Interval|Median
121072|NCT00633594|Secondary|Duration of Response (DoR) of Previously Treated and Previously Untreated Participants|Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)||months||95% Confidence Interval|Median
121073|NCT00633594|Secondary|Duration of Response (DoR) of Phase I and Phase II Participants|"Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.~Duration of Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression|All participants that received study treatment that were responders (achieved a PR or better)||months||95% Confidence Interval|Median
121074|NCT00633594|Secondary|Time to Best Response of Previously Treated and Previously Untreated Participants|Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All patients that received study treatment that were evaluable for a response assessment (2 previously untreated participants and 1 previously treated participant were considered unevaluable, discontinuing prior to first post-baseline response assessment)||months||95% Confidence Interval|Median
121075|NCT00633594|Secondary|Time to Best Response of Phase I and Phase II Participants|"Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.~Time to Best Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification."|Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years|All participants that received study treatment that were evaluable for a response assessment (one participant in Phase I and two participants in Phase II were considered unevaluable, discontinuing prior to first post-baseline response assessment)||days||Full Range|Median
121076|NCT00633594|Secondary|Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)||Participants|||Count of Participants
121077|NCT00633594|Secondary|Overall Response Rate (ORR) of Phase I and Phase II Participants|Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.|Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months|The efficacy evaluable population (all participants who have received any study treatment)||Participants|||Count of Participants
121078|NCT00633594|Primary|Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II|"A count of affected participants with non-serious adverse events (regardless of relationship to study treatments) occurring in >= 15% of treated patients enrolled in the Phase II section of the study.~Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 subcutaneous Days 1, 4, 8, and 11 for Cycles 1-6"|Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment|Includes patients that were enrolled in the Phase II section of the study||participants|||Number
121079|NCT00633594|Primary|Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants|"Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03.~MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab.~Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neuropathy, grade 3 rash)"|Collected from day of first dose to the end of the first treatment cycle, up to 21 days|Includes patients that were enrolled in both lenalidomide dose levels (10 mg PO daily, 15 mg PO daily) in the Phase I portion of the study||mg lenalidomide, orally, daily, day 1-14|||Number
121080|NCT00634322|Primary|Patients Progressing to Next Chemotherapy Cycle||1 week after intervention||||||
121081|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - Therapeutic Dose (mg/kg)^0.75|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (ages 3 to 18) - Therapeutic Dose (mg/kg)^0.75. Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Therapeutic Dose (mg/kg)^0.75||Standard Deviation|Mean
121082|NCT00634270|Secondary|To Evaluate the Role of Apolipoprotein E Genotypes as Predictors for Development of Hyperlipidemia During Therapy With Sirolimus.|Number of patients who experienced hyperlipidemia is being reported.|24 weeks Stratum 1 / 48 weeks Stratum 2|Only one patient experienced hyperlipidemia during sirolimus therapy.||participants|||Number
121083|NCT00634270|Secondary|To Evaluate Pharmacogenetic Polymorphisms of Cytochrome P450 3A4 & 3A5 Alleles and P-glycoprotein/MDR for Their Influence on the Metabolism of Sirolimus in This Patient Population.|Trough concentration of sirolimus is reported in nanograms per mL.|24 weeks Stratum 1 Only|Subjects in Stratum 1.||ng/mL||Standard Deviation|Mean
121084|NCT00634270|Secondary|To Evaluate the Effect of Sirolimus on Clinical Response by Reduction in Pain, or Improvement in Function or Performance Scale.|There were no data collected for this outcome measure.|24 weeks Stratum 1 / 48 weeks Stratum 2||||||
121085|NCT00634270|Secondary|To Asses Preliminary Correlations of Radiographic Response With Changes in Pharmacodynamics Parameters Including p70s6 Kinase Activity in Peripheral Blood Mononuclear Cells.|Response by Volumetric MRI.|24 weeks Stratum 1 / 48 weeks Stratum 2|Samples were inadequate in quantity to allow for this analysis.|||||
121086|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus in When Administered to This Patient Population - Therapeutic Dose (mg/kg Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients (Ages 3 to 18) Therapeutic Dose (mg/kg per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Therapeutic Dose (mg/kg per dose)||Standard Deviation|Mean
121087|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population- Therapeutic Dose (mg/m^2 Per Dose)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 patients - Therapeutic Dose (mg/m^2 per dose). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Therapeutic Dose mg/m^2 per dose||Standard Deviation|Mean
121088|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population - (Clearance (L/h Per 1.85 m^2)|An iterative 2-stage Bayesian Method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1, Neurofibromatosis Type 1 Patients Clearance (L/h per 1.85 m^2). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||L/h per 1.85 m^2||Standard Deviation|Mean
121089|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus When Administered to This Patient Population Using Liters/Hour Per Population Median Weight of 70kg (L/h70kg)|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Stratum 1 used allometrically scaled clearance (clearance scaled to a 70kg individual). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||L/h/70kg||Standard Deviation|Mean
121090|NCT00634270|Secondary|To Assess the Value of Three-dimensional MRI (3-D MRI) in the Evaluation of Plexiform Neurofibromas and Paraspinal Neurofibromas, and to Compare 3-D MRI to Conventional Two-dimensional MRI (2-D MRI) and One Dimensional MRI (1-D MRI) Data Analysis|The study provided central review of all MRIs using a three-dimensional volumetric protocol. As the STOPN protocol began, research had already demonstrated the superiority of this approach to 1-D or 2-D analyses, so these were not used in the STOPN study.|24 weeks Stratum 1 / 48 weeks Stratum 2||||||
121091|NCT00634270|Secondary|To Evaluate the Quality of Life During Treatment With Sirolimus by Assessing Preliminary Correlations of Response With Quality-of-life Outcomes|Self-reported, age-appropriate PedsQL Scale. Assessments included: Inventory for physical function, emotional function, social function and school function - number system 0-4 was used with 4 being the worse maximum threshold); inventory for chronic illness used a 5-point likert scale - 5 being the worst maximum threshold; Skindex-Teen used a scale of 0 to 100 - the higher the number the more frequent the experience; Pain intensity was measured using a line with a happy and sad face - marks toward the sad face indicated more intense pain; and, the McGill Pain Questionnaire - higher values indicating worse pain of a scale from 0-3. All assessments were combined for an overall PedsQL score by rating each item 0-4; then transformed to a 0 – 100 scale. The means were calculated for the subscales and total score with higher scores being better.|24 weeks Stratum 1 / 48 weeks Stratum 2|Stratum 1 patients with Neurofibromatosis Type 1; all ages - Change from Baseline to Course 3. Stratum 2 did not meet the requirements for response at the 6 month time point. Therefore, Stratum 2 was not analyzed for this aim.||Units on a scale||Standard Deviation|Mean
121092|NCT00634270|Primary|To Characterize the Pharmacokinetic Profile of Sirolimus Administered to This Patient Population (Clearance Liters/Hour (L/h))|An iterative 2-stage Bayesian method was used for the PK parameter analyses|Pre-dose; Day 1 at 0.5 hours, 1.0 hours, 2.0 hours, 3.0 hours, 4.0 hours, 6.0 hours, 8.0 hours, and 10.0 to 12.0 hours|Pediatric Patients (3 through 18) with Neurofibromatosis Type 1 - Clearance liters/hour (L/h). Stratum 2 did not meet the 6 month response criteria; therefore, was not analyzed for pharmacokinetic profiles.||Clearance liters/hour (L/h)||Standard Deviation|Mean
121093|NCT00634270|Primary|Toxicity|Number of participants experiencing adverse events|24 weeks Stratum 1 / 48 weeks Stratum 2|All evaluable participants for Stratum 1 and 2 combined.||Participants|||Number
121094|NCT00634270|Primary|Results in Objective Radiographic Responses Based on Volumetric MRI Measurements in Children and Adults With NF1 and Inoperable PN in the Absence of Documented Radiographic Progression at Trial Entry|Stratum 2 outcome - Response|48 weeks Stratum 2|Identify the index plexiform neurofibroma(s) for 3-D MRI evaluation based on prior imaging studies. The criteria for response was <20% increase in volume using RECIST v1.0. Response for 48 weeks was only assessed for Stratum 2.||participants|||Number
121095|NCT00634270|Primary|Time to Disease Progression Based on Volumetric MRI|Median time to progression in Stratum 1 as defined as an increase of at least 20% of the volume of the primary lesion. Note: Since Stratum 2 looked at response rate only, median time to progression was not reviewed for this outcome.|24 Months Stratum 1|"All evaluable participants. Note: In Stratum 2 the value was not assessed as time to progression therefore the appropriate response would be N/A. Stratum 2 was reported as response rate only."||Months||95% Confidence Interval|Median
121096|NCT00634244|Secondary|The Rate of Treatment Failure|"The definition of treatment failure will include:~≥ 5% leukemic blasts at the time of pre-consolidation marrow~Death during/following induction chemotherapy (pre-consolidation)~Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy~CNS or extramedullary disease at the time of pre-consolidation~Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy"|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated||proportion of participants||90% Confidence Interval|Number
121097|NCT00634244|Primary|The Rate of Complete Remission (CR+CRi)|CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100 x 10^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L).|Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.|Eligible and treated||proportion of participants||90% Confidence Interval|Number
121098|NCT00634179|Secondary|An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria|Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response.|Following completion of therapy, up to 2 years|||participants|||Number
121099|NCT00634179|Primary|Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.|Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks|||mg/m^2||95% Confidence Interval|Number
121100|NCT00634166|Secondary|The Secondary Objective is to Examine the Reasons for Graft Loss in Subjects Treated With Sulfamylon® Solution Versus Historical Controls.||Secondary analyses will include the percent of subjects with All Cause Graft Loss at Days 12-14 and Days 18-21; Treatment Failure at Days 5-7; and Infectious Graft Loss at Days 5-7, Days 12-14 and Days 18-21.||||||
121101|NCT00634166|Primary|Percentage of Participants With Graft Loss After Initial Meshed Autograft Procedure on Days 5-7.||The primary analysis will compare the percent of subjects with All Cause Graft Loss of the initial meshed autograft procedure at Days 5-7.|||Percentage of Participants|||Number
121102|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.|Up to 12 weeks|||Participants|||Number
121103|NCT00634114|Primary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.|Up to 24 weeks|||Participants|||Number
121104|NCT00634114|Secondary|Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment|Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.|up to 4 weeks|||Participants|||Number
121105|NCT00634088|Secondary|Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib|Duration of response is measured from the time in months that measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented PD or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.|First occurrence of PR or CR to PD or Death (no average, as no data available)|Because the study was terminated due to insufficient enrollment, the duration of response could not be analyzed.|||||
121106|NCT00634088|Secondary|Overall Tumor Response By Number of Participants|Target lesion criteria: Complete Response(CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial Response (PR)=A 30% or greater decrease in the sum of longest diameter(LD) of all lesions in reference to the baseline sum LD. Stable Disease (SD)=Insufficient increase to qualify for Progressive Disease (PD) and insufficient shrinkage to qualify for PR; PD=A 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|Baseline and Day 21 (21-day cycle)|All participants with measurable disease at baseline per RECIST guidelines, with the exception of those with an incorrect diagnosis.||Participants|||Number
121107|NCT00634088|Primary|MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine|MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a DLT, with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, no participants received the triplet combination.|||||
121108|NCT00634088|Secondary|Volume of Distribution at Steady State of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||Liters||Standard Deviation|Mean
121109|NCT00634088|Secondary|Time to Peak Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||Hours||Full Range|Median
121110|NCT00634088|Secondary|Terminal Half-life of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||Hours||Standard Deviation|Mean
121111|NCT00634088|Secondary|Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||ng*h/mL||Standard Deviation|Geometric Mean
121112|NCT00634088|Secondary|Maximum Concentration of Ixabepilone||Day 1 of 21-day cycle|Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available.||ng/mL||Standard Deviation|Geometric Mean
121113|NCT00634088|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. ALT(U/L) Gr 1:>ULN–2.5*ULN,Gr 2:>2.5–5.0*ULN,Gr 3:>5.0–20.0*ULN,Gr 4:>20.0* ULN; AST(U/L) Gr 1:>ULN–2.5* ULN,Gr 2:>2.5–5.0*ULN,Gr 3:>5.0–20.0*ULN,Gr 4:>20.0* ULN; ALP(U/L)Gr 1:>ULN–2.5*ULN, Gr 2:>2.5–5.0*ULN, Gr 3:>5.0-20.0*ULN, Gr 4:>20.0*ULN; Creatinine (mg/dL): Gr 1:>ULN–1.5*ULN, Gr 2:>1.5–3.0*ULN, Gr 3:>3.0–6.0*ULN, Gr 4:>6.0*ULN; Total bilirubin (mg/dL): Gr 1:>ULN–1.5*ULN, Gr 2:>1.5–3.0*ULN, Gr 3:>3.0–10.0*ULN, Gr 4:>10.0*ULN|At baseline and within 72 hours of Day 1 of 21-day cycle|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
121165|NCT00633880|Secondary|Change in Concentration (OHSA Item 5)|OHSA item 5 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
121114|NCT00634088|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade|CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC (c/uL): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count (c/uL): Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0*10^9/L; Hemoglobin (g/dL): Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|Baseline and weekly from Days 1 to 21 (Cycle 1)|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
121115|NCT00634088|Secondary|Number of Participants With DLT|DLT=Any of the following events, attributable to study drug and occurring within 21 days after ixabepilone administration: Grade 3 or 4 nausea, vomiting, or diarrhea despite the use of adequate medical intervention; other Grade 3 or greater nonhematologic toxicity requiring removal from study drug; recovery from study drug-related toxicity that delayed scheduled retreatment for longer than 3 weeks; Grade 4 neutropenia for 5 or more consecutive days or Grade 3 or 4 neutropenia of any duration with sepsis or fever; thrombocytopenia or bleeding requiring platelet transfusion.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
121116|NCT00634088|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4)|AE=Any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, important, a congenital anomaly/birth defect; or requires or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Common Terminology Criteria (CTC) Grade 3=severe; Grade 4=life-threatening or disabling.|Baseline to Day 21, continuously|All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine.||Participants|||Number
121117|NCT00634088|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib|The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.|Days 1 through 21|Because the study was terminated due to insufficient enrollment, MTD was not achieved.|||||
121118|NCT00634049|Secondary|Safety - Overall Number of TEAEs|A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.|From the first study drug administration until 28 days after the last dose of study drug|The safety analysis set (SAF) consists of all enrolled participants who received at least one dose of study drug as this was a non-comparative open-label study||participants|||Number
121119|NCT00634049|Secondary|All-cause Mortality Through Day 42 and Day 84|"All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Baseline to End of Treatment (EOT [Day 180])|Intent-To-Treat population (ITT)||percentage of participants|||Number
121120|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
121121|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
121122|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT|"The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, Day 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
121123|NCT00634049|Secondary|Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
121124|NCT00634049|Secondary|Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
121125|NCT00634049|Secondary|Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT|"The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings].~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
121126|NCT00634049|Primary|Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).|"The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD~End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days."|Day 42, 84 and End of Treatment (EOT [Day 180])|Modified Intent-To-Treat population (mITT)||percentage of participants|||Number
121127|NCT00634010|Primary|Participant Pain Severity Score Measured Using Brief Pain Inventory|Brief Pain Inventory (BPI): Pain severity measured with BPI, which asks participants to rate pain for last 24 hours on 0 to 10 scales at its “worst”, “least”, “average “ and “now”. The scales are presented on a 10 cm line, with each number equidistant from the next. Each scale is bounded by the words “no pain’ at the 0 end and “pain as bad as you can imagine” at the other. BPI used to determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 4 week (+/- 3 days) treatment period in participants with advanced cancer.|Comparing baseline and pain scores at 4 weeks (+/- 3 days)|The study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups. Participants eligible for the study often had significant symptom distress and could not continue in the four week study period needed for data collection contribution to mean calculation.|||||
121128|NCT00633984|Primary|CGI - Clinical Global Impression of Improvement|"The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global severity of symptoms. The CGI-I ranges from 1 (very much improved) to 7 (very much worse). Response and remission was defined as an improvement score of 1 (very much improved) or 2 (much improved) on the CGI-I."|Week 13|||units on a scale||95% Confidence Interval|Mean
121129|NCT00633984|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of < 30 on the Liebowitz Social Anxiety Scale|Week 13|||units on a scale||95% Confidence Interval|Mean
121130|NCT00633932|Secondary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification"|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|4 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.||participants|||Number
121131|NCT00633932|Primary|"Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification."|Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).|8 weeks|One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.||participants|||Number
121132|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007|"The treatment efficacy was rated by both subject and investigator at the end of the evaluation period in autumn 2007. Subjects rated their asthma symptoms in comparison to previous autumns and investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.~The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2007: All available data were used to their full extent, but no imputation of data was performed.||Participants|||Number
121133|NCT00633919|Secondary|Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008|"The treatment efficacy was rated by investigators at the end of the evaluation period in autumn 2008. Investigators rated the asthma symptoms in comparison to when subjects entered the trial, using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.~The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.||Participants|||Number
121567|NCT00630058|Primary|Ctrough (Minimum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
121134|NCT00633919|Secondary|Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008|"The treatment efficacy was rated by subjects at the end of the evaluation period in autumn 2008. Subjects rated their asthma symptoms in comparison to previous autumn using the categories: “much worse”, “worse”, “the same”, “better”, or “much better”.~The categories “much better” or “better” were grouped as “improved”. The categories “the same”, “worse” or “much worse” were grouped as “not improved”."|8 weeks|All analyses were on all randomised participants (full analysis set) with data in 2008: All available data were used to their full extent, but no imputation of data was performed.||Participants|||Number
121135|NCT00633919|Secondary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2007. All available data were used to their full extent, but no imputation of data was performed.||Scores on a scale||Standard Deviation|Mean
121136|NCT00633919|Primary|Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008|"Scoring per inhalation/tablet: 1-2 inhalations twice daily of salbutamol (200 ug per inhalation), 2 scores; 1-2 inhalation twice daily of budesonide/formoterol 80 (4.5 ug per inhalation), 4 scores; 1 inhalation twice daily of budesonide/formoterol 160 (4.5 ug per inhalation), 8 scores; up to 10 tablets once daily of prednisone (5 mg), 1.6 scores. The total maximum daily scores were 40.~The daily score for each medication step was calculated by multiplying the score per inhalation/tablet with the number of inhalations/tablets used (entered as units in the daily diary by the subject)."|8 weeks|Data were based on subjects from the Full Analysis Set (FAS; all randomised subjects following the ITT ICH principle) who had at least one record in the daily diary in the 2 months evaluation period in autumn 2008. All available data were used to their full extent, but no imputation of data was performed.||Scores on a scale||Standard Deviation|Mean
121137|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 7, 4, 14 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
121138|NCT00633893|Secondary|Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 10 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
121139|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 2, 3, 7 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
121166|NCT00633880|Secondary|Change in Vision (OHSA Item 2)|OHSA item 2 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
121167|NCT00633880|Secondary|Change in Weakness (OHSA Item 3)|OHSA item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
121140|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 8, 4, 15 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
121141|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 6, 8, 53 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
121142|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 76 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
121143|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Participants analyzed per randomized treatment assigned. (n) number of events = 14, 14, 73 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||proportion of participants||95% Confidence Interval|Number
121144|NCT00633893|Secondary|Adjudicated Total Bleeding During the Treatment Period - Treated Participants|All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 94, 121, 74 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
121145|NCT00633893|Secondary|Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants|All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 75, 98, 58 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
121168|NCT00633880|Secondary|Change in Fatigue (OHSA Item 4)|OHSA item 4 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
121146|NCT00633893|Secondary|Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Treated population includes randomized participants who received at least one dose of study drug. (n)number of events = 25, 34, 19 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
121147|NCT00633893|Secondary|Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants|Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated participants were those who received at least 1 dose of study drug. (n)number of events = 27, 35, 22 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively.||proportion of participants||95% Confidence Interval|Number
121148|NCT00633893|Secondary|Adjudicated Major Bleeding During the Treatment Period - Treated Population|Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.|Day 1 up to 12 Months|Treated population includes randomized participants who received at least one dose of study drug. (n) number of events = 2, 1, 4 in apixaban 2.5 mg, and 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
121149|NCT00633893|Secondary|Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation|All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. In first event (first primary event) each participant counted once. In event category, each participant was counted only once in each event category but could have been counted in multiple categories.||participants|||Number
121150|NCT00633893|Secondary|Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. (n) number of events = 22, 25, 33 in apixaban 2.5 mg, apixaban 5 mg, and placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
121151|NCT00633893|Secondary|Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation|CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. number of events (n)= 17, 24, 29 in the apixaban 2.5 mg, 5 mg, placebo arms, respectively.||Proportion of Participants||95% Confidence Interval|Number
121152|NCT00633893|Secondary|Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 17, 24, 26 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
121153|NCT00633893|Secondary|Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation|PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 23, 25, 37 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
121154|NCT00633893|Secondary|Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation|DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 Months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned. (n) number of events = 19, 28, 72 in apixaban 2.5 mg, 5 mg, placebo arms, respectively.||Proportion of participants||95% Confidence Interval|Number
121155|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent.(n)number of events=27, 34, 95 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. The (n)number of imputed events were = 13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on the Wald asymptotic confidence limits||proportion of participants||95% Confidence Interval|Number
121156|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation|VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.|Day 1 up to 12 months|Intent to treat: all randomized participants with valid consent. Analyzed per randomized treatment assigned.(n)number of events = 19, 14, 77 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively. All events were counted; no events were imputed.||Proportion of participants||95% Confidence Interval|Number
121169|NCT00633880|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|Missing data were imputed using the last observation carry forward method.||units on a scale||Standard Deviation|Mean
121170|NCT00633867|Primary|Intubation Time|Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation|At intubation|||seconds||Inter-Quartile Range|Median
121171|NCT00633867|Secondary|Incidence of Visible Trauma to the Airway||At analysis||||||
121172|NCT00633867|Secondary|Incidence of Low Arterial Saturation During Intubation||At analysis||||||
121173|NCT00633867|Secondary|Number of Intubations Taking More Than 70 Seconds||At Analysis||||||
121174|NCT00633867|Secondary|Incidence of Initial Oesophageal Intubation||At analysis||||||
121157|NCT00633893|Secondary|Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation|VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|ITT: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=27, 34, 92 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. Number of imputed events=13, 20, 19 in apixaban 2.5 mg, 5 mg, placebo arms, respectively. CI for single event rate was calculated based on Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
121158|NCT00633893|Primary|Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation|VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.|Day 1 up to 12 Months|Intent to treat: all randomized participants with consent. Analyzed per randomized treatment assigned. (n) number of events=32, 34, 96 in apixaban 2.5 mg, 5 mg, and placebo arms, respectively; number of events imputed=13, 20, 19, respectively. Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits.||Proportion of participants||95% Confidence Interval|Number
121159|NCT00633880|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing;|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|three placebo patients excluded from the analysis due to missing standing blood pressure values at either randomization or end of study.||mmHg||Standard Deviation|Mean
121160|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Scores Excluding Dizziness (OHSA Composite Items 2-6)|OHSA composite scale (items 2-6) is the average of five OHSA items: 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|"One placebo patient excluded from analysis per the SAP because all baseline values in the composite were zero.~LOCF was used to impute values for patients who did not have an end of study visit."||units on a scale||Standard Deviation|Mean
121161|NCT00633880|Secondary|Change in Orthostatic Hypotension Symptom Assessment Score (OHSA Composite)|The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
121162|NCT00633880|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|One placebo patient excluded from analysis because OHDAS values were not evaluable.||units on a scale||Standard Deviation|Mean
121163|NCT00633880|Secondary|Change in Head/Neck Discomfort (OHSA Item 6)|OHSA item 6 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) .|14 days|||units on a scale||Standard Deviation|Mean
121164|NCT00633880|Post-Hoc|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug) ."|14 days|3 droxidopa patients and 2 placebo patients were excluded from the analysis due to missing randomization values.||units on a scale||Standard Deviation|Mean
121175|NCT00633867|Secondary|Number of Attempts to Secure Successful Intubation|Is there a difference in the number of attempts required to secure successful intubation ?|At analysis||||||
121179|NCT00633750|Secondary|Molecular Profile of Participants Who Are Responsive to Tarceva|Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = > 10% of cell show staining, negative = < 10% of cells show staining|at 5-14 days|Participants with available pre- and post-treatment tissue and who demonstrated a post-treatment decrease in Ki67 levels compared to their pre-treatment levels||participants|||Number
121180|NCT00633750|Primary|Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva|In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.|5-14 days|Patients who received the study drug and who had available pre- and post-treatment tissue.||participants|||Number
121181|NCT00633256|Secondary|Urinary Cotinine Level|Urinary Cotinine level at the 4-week follow up timepoint|4 Week Follow-up Timepoint|Subjects used for analysis are those who reached the 4 week followup timepoint.||Mean ng/ml||Standard Deviation|Mean
121182|NCT00633256|Secondary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 4-week follow up timepoint.|4 Week Followup|The number of subjects in the study at the 4-week timepoint.||Cigarettes per day||Standard Deviation|Mean
121183|NCT00633256|Primary|Cigarettes Smoked Per Day|The number of cigarettes smoked per day at the 1 week follow up time point.|1 week follow-up|The number of participants used for analysis were those who completed the 4-week follow-up timepoint.||Cigarettes per day||Standard Deviation|Mean
121184|NCT00633243|Primary|Number of Participants With a Sustained Virologic Response (SVR)|SVR is defined as continued undetectable HCV viral load at 24 weeks|24 weeks (end of treatment)|All subjects in mDOT arm and SAT arm who completed treatment.||participants|||Number
121185|NCT00633217|Secondary|Mean Change From Baseline in Peak Expiratory Flow|The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. This is measured by a peak flow meter which is a hand held device. Change from baseline was calculated as the average value over Weeks 1-12 minus the baseline value.|Baseline through Week 12|ITT Population. Some participants did not have measured values for peak expiratory flow and were thus not included in the analysis.||Liters/minute (L/min)||Standard Error|Mean
121186|NCT00633217|Secondary|Mean Change From Baseline in AM Pre-dose FEV1|Change from baseline was calculated as the value at Endpoint minus the baseline value. AM pre-dose FEV1, which is assessed using spirometry, is the maximum amount of air you can forcefully exhale in one second prior to taking the morning dose of study drug. Endpoint was defined as the last scheduled observation for AM pre-dose FEV1 during the 12-week treatment period.|Measurement of FEV1 prior to study drug administration; Baseline through Week 12|ITT Population. The numbers analyzed do not match Baseline numbers due to missing data for some participants.||mL||Standard Error|Mean
121187|NCT00633217|Primary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) 2 Hours Post-dose of Blinded Study Drug|The primary efficacy analysis was mean change from baseline in 2-hour post-dose FEV1 compared between the two treatment groups at Endpoint. Change from baseline was calculated as the value at Endpoint minus the baseline value. FEV1, which is assessed using spirometry, is the maximal amount of air you can forcefully exhale in one second. Endpoint was defined as the last scheduled observation for 2 hour post-dose FEV1 during the 12-week treatment period.|2 hours after administration of blinded study drug; Baseline through Week 12|Intent-to-Treat (ITT) Population: all participants who had been randomized to study drug. The numbers analyzed do not match Baseline numbers due to missing data for some participants.||milliliters (mL)||Standard Error|Mean
121188|NCT00633152|Primary|Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 Days after end of therapy)|The Clinically Evaluable (CE) Population included all subjects who satisfied key minimum protocol criteria||percentage of participants||95% Confidence Interval|Number
121189|NCT00633152|Secondary|The Safety of Ceftaroline Fosamil|Evaluate safety of Ceftaroline fosamil IM in adults with cSSSI|First dose of study drug through LFU Visit or 30 days after the last dose of study drug||||||
121190|NCT00633152|Secondary|The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit|Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit.|LFU Visit (21 to 35 days after end of therapy)||||||
121191|NCT00633152|Secondary|Clinical Relapse at the Late Follow-up Visit|Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit.|Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)||||||
121192|NCT00633152|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations|Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.|TOC Visit (8 to 15 days after end of therapy)||||||
121193|NCT00633152|Secondary|The Microbiological Response at the TOC Visit in the mMITT and ME Populations.|Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.|TOC Visit (8 to 15 days after end of therapy)||||||
121194|NCT00633152|Secondary|Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.|Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.|End-of-therapy (EOT) visit||||||
121195|NCT00633152|Secondary|Clinical Cure Rate at the TOC Visit in the cMITT Population|Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.|TOC Visit (8 to 15 days after end of therapy)||||||
121212|NCT00633074|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
121196|NCT00633152|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population|The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.|Test of Cure Visit (8 to 15 days after end of therapy)|Modified-Intent-to-Treat (MITT) Population - Any randomized subjects that received any amount of study drug||percentage of participants||95% Confidence Interval|Number
121197|NCT00633139|Secondary|Change in Cerebrospinal Fluid (CSF) Sulfatide|Changes in CSF sulfatide from baseline to end of study (Week 52). Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population||%change in CSF sulfatide||95% Confidence Interval|Mean
121198|NCT00633139|Primary|Relative Change in Mullen's Scales of Early Learning|Changes in Mullen's Scales of Early Learning are measured from baseline to end of study (Week 52) using Mullen's Scales of Early Learning. T scores, percentile ranks, and age equivalents can be computed for the four scales separately (visual reception, fine motor, expressive language, and receptive language). Relative change is calculated as percentage change from baseline divided by the age-difference in months between first and last visit. When Mullen's score decreases over time, it indicates the disease worsened over time. Data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|ITT population.||Relative % change in Mullen's SOT||95% Confidence Interval|Mean
121199|NCT00633139|Primary|Relative Changes (%) in Gross Motor Function Measurement (GMFM)|Change (percent change) in GMFM is measured from baseline to end of study (Week 52). GMFM is measured using GMFM-88. The GMFM-88 item scores can be summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score is between 0 (minimal) to 3 (maximum). The total GMFM-88 score is between 0 (minimal) to 264 (maximum). Relative changes in GMFM are calculated as percentage change from baseline divided by the age difference in months between first and last visit. The GMFM score decreases over time, which, indicates that the disease worsened over time. Score over time (SOT), data mentioned over mean represents the adjusted mean.|Baseline, 52 Weeks|Intent to Treat (ITT) population included all the participants in the study.||Relative % change in total GMFM-88 SOT||95% Confidence Interval|Mean
121200|NCT00633126|Secondary|Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).|"A TEAE is any untoward medical occurrence a subject experiences following study drug administration.~Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7."|Signing of ICF to last FU visit, study day 7 (+-2 days).|"per protocol~Out of 9 participants analyzed, 1 subject did not receive the full dose of study drug."||events|||Number
121201|NCT00633126|Primary|The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.|The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion.|12 hours after infusion|per protocol||ng/mL||Standard Deviation|Mean
121202|NCT00633087|Secondary|Overall Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
121203|NCT00633087|Secondary|Progression-free Survival||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
121204|NCT00633087|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
121205|NCT00633087|Primary|To Determine the Biochemical Response of This Regimen in Patients With HRPC|A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.|5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
121206|NCT00633074|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
121207|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
121208|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During a 21-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
121209|NCT00633074|Secondary|Duration of Solicited General Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
121210|NCT00633074|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
121211|NCT00633074|Secondary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.|During a 7-day period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
121213|NCT00633074|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains|A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
121214|NCT00633074|Secondary|HI Antibody Seroconversion Factors|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
121215|NCT00633074|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
121216|NCT00633074|Secondary|Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
121217|NCT00633074|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
121218|NCT00633009|Secondary|The Safety of 15, 30 and 50µg/0.1mL Doses of LtSTA in Healthy Adult Volunteers Who Have Had no Known Previous Exposure to Leishmania Parasites|Local and systemic events following skin test. Local: burning, itching, pain. Systemic: Body aches, dizziness, nausea, weakness.|74 days|||No. of participants with reactions|||Number
121219|NCT00633009|Primary|Sensitizing Effects of LtSTA in Leishmania Naive Adults|Skin test response of subjects in the trial were evaluated 48 hours post injection after each of three skin test given at 30 day intervals in naive individuals (no exposure to the Leishmania organism). (Actual times 0, 30 and 60 days).The outcome measure was designated as number of participants who became sensitized to the Leishmania antigen. This is defined as those participants that had a negative skin test result, followed by a positive response in a subsequent skin test without having been exposed to the Leishmania organism.|62 days|Number of participants completed.||participants|||Number
121220|NCT00632931|Primary|Change From Baseline in QTcF at 24 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 24 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121221|NCT00632931|Primary|Change From Baseline in QTcF at 12 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 12 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121222|NCT00632931|Primary|Change From Baseline in QTcF at 8 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 8 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121223|NCT00632931|Primary|Change From Baseline in QTcF at 4 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The placebo-corrected change from baseline in QTcF was calculated by subtracting the QTcF change from baseline for placebo at each timepoint from the QTcF change from baseline for vorinostat at each timepoint.|Baseline and 4 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121241|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of Cytarabine in Plasma)|Tmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)||hours||Full Range|Median
121224|NCT00632931|Primary|Change From Baseline in QTcF at 3 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 3 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121225|NCT00632931|Primary|Change From Baseline in QTcF at 2 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 2 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121226|NCT00632931|Primary|Change From Baseline in QTcF at 1 Hour|Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 1 hour|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121227|NCT00632931|Primary|Change From Baseline in QTcF at 0.5 Hours|The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.|Baseline and 0.5 hours|"All patients as treated population in Part 1 of the Study;~22 patients had QTcF data from the vorinostat period (One patient with protocol violation, and two patients without predose measurements were excluded) and 23 patients had QTcF data from the placebo period (one patient with protocol violation and one patient who discontinued were excluded)"||milliseconds||95% Confidence Interval|Mean
121228|NCT00632814|Secondary|Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.||Scores on a scale||Standard Deviation|Mean
121229|NCT00632814|Secondary|Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)|Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).|9 months|Participants who completed the questionnaire.||Scores on a scale||Standard Deviation|Mean
121230|NCT00632814|Secondary|Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment|The assessment of joint function using Stockholm Joint Score. The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).|baseline and 9 months|||Scores on a scale||Standard Deviation|Mean
121231|NCT00632814|Secondary|Actual Monthly rFVIII-FS Consumption||Up to 9 months|||IU/kg||Standard Deviation|Mean
121232|NCT00632814|Secondary|Number of Participants in Each Group at the End of the Study||Up to 9 months|Participants were allowed to switch treatment groups upon occurrence of joint bleed. Therefore the number of participants per group at the end of the study is different from the number of participants per group at baseline.||Participants|||Number
121233|NCT00632814|Secondary|Number of Participants With Joint Bleeds During the 9-month Treatment Period||Up to 9 months|||Participants|||Number
121234|NCT00632814|Secondary|Number of Participants With Bleeding Events During the 9-month Treatment Period||Up to 9 months|||Participants|||Number
121235|NCT00632814|Secondary|Number of Bleeds Per Participant During the 9-month Treatment Period||Up to 9 months|||bleeds per participant||Full Range|Median
121236|NCT00632814|Primary|Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period||Up to 9 months|||Percentage of participants|||Number
121237|NCT00632749|Secondary|Pharmacokinetics of Cytarabine After a Single Dose and at Steady State When Given Alone|"The study protocol originally included a phase II part with a treatment arm in which Cytarabine was given alone, however the sponsor discontinued the clinical development of BI 811283, therefore the protocol was amended and the reference therapy arm was removed from the study protocol” -> (Protocol Amendment 5, version 19 -May-2010, approved 28-Jun-2010).~Since there was never a treatment arm in which Cytarabine was given alone; hence pharmacokinetics are not calculated."|-0.05, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours|Treated set|||||
121238|NCT00632749|Secondary|Pharmacodynamic Monitoring|"Pharmacodynamic monitoring: drug effect on leukaemia cells (e.g. polyploidy, histone H3 phosphorylation, morphologic changes).~An evaluation of this secondary endpoint is not possible due to missing samples / samples of poor quality of the provided material."|On Day 5, i.e. 72 hours after the end of the first BI 811283 infusion, and on Day 28 in the first cycle only|Treated set|||||
121239|NCT00632749|Secondary|AUC (0-tz) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC (0-tz) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)||ng·h/L||Geometric Coefficient of Variation|Geometric Mean
121240|NCT00632749|Secondary|AUC (0-inf) (Area Under the Concentration-time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-inf) of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated set (Only patients with observed cases (OC) values were analysed)||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
122114|NCT00623779|Primary|Premature Discontinuation of Study or Study Drug Due to Any Reason|The premature discontinuation of study or study drug due to any reason|28 week (randomisation visit to last follow up visit in study) according to protocols|||Participants|||Number
121242|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of Cytarabine in Plasma)|Cmax of Cytarabine after a 20 mg Subcutaneous Dose on the First Day of BI 811283|-0.05 hours before and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 hours after administration of Cytarabine|Treated Set (Only patients with observed cases (OC) values were analysed)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
121243|NCT00632749|Secondary|Tmax,ss (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|tmax,ss (time from dosing to maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||hours||Full Range|Median
121244|NCT00632749|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration of BI 811283 in Plasma)|tmax (time from dosing to maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)||hours||Full Range|Median
121245|NCT00632749|Secondary|AUC (0-tz,ss) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) at Steady State|AUC (0-tz,ss) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
121246|NCT00632749|Secondary|AUC (0-inf, ss)(Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity) at Steady State|AUC (0-inf, ss)(area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) at steady state during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
121247|NCT00632749|Secondary|Cmax,ss (Maximum Measured Concentration of BI 811283 in Plasma at Steady State)|Cmax (maximum measured concentration of BI 811283 in plasma at steady state) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed). Steady state analyses is not applicable for Treatment Schedule B, since pharmacokinetic analyses was performed after a single dose for Treatment Schedule B.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
121248|NCT00632749|Secondary|AUC0-tz (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|AUC0-tz (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 to the time of the last quantifiable data point) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
121249|NCT00632749|Secondary|AUC(0-inf) (Area Under the Concentration-time Curve of BI 811283 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC(0-inf) (area under the concentration-time curve of BI 811283 in plasma over the time interval from 0 extrapolated to infinity) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated set (Only patients with observed cases (OC) values were analysed)||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
121250|NCT00632749|Secondary|Cmax (Maximum Measured Concentration of BI 811283 in Plasma)|Cmax (maximum measured concentration of BI 811283 in plasma) during Cycle 1|-0.05 hours before and 1:00, 4:00, 6:00, 24:00, 25:00, 26:00, 28:00, 32:00, 36:00, 48:00 hours after administration of BI 811283|Treated Set (Only patients with observed cases (OC) values were analysed)||nmol/L||Geometric Coefficient of Variation|Geometric Mean
121251|NCT00632749|Secondary|Overall Survival (OS)|OS was defined for all patients that entered the trial, and measured from the date of randomization until death from any cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set||days||Standard Deviation|Mean
121252|NCT00632749|Secondary|Remission Duration|Remission duration analysis was defined only for patients who achieved CR, and was measured from the date of attaining CR until the date of disease recurrence (relapse). For patients who died without report of relapse, remission duration was censored on the date of death, regardless of the cause.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)||days||Standard Deviation|Mean
121253|NCT00632749|Secondary|Relapse Free Survival|"Relapse-free survival was defined only for patients who achieved CR/CRi and was measured from the date of attaining CR/CRi until the date of recurrence or death from any cause, whichever occurred first.~Number of patients having relapse free survival are presented."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set (Only patients with observed cases (OC) values were analysed)||participants|||Number
121254|NCT00632749|Secondary|Event Free Survival (EFS)|EFS was defined as the duration of time from randomisation to time of treatment failure (i.e. PD), relapse from CR, or death from any cause, whichever came first.|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set||days||Standard Deviation|Mean
121267|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ADHD Symptoms|sum of severity rating for all 18 DSM (Diagnostic and Statistics Manual for Mental Disorders) IV ADHD symptoms and two from DSM 3R on a 0 to 3 scale obtained from parent rating; range is from 0 to 60 with higher numbers indicating more severe symptoms|Measured at Week12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
121255|NCT00632749|Secondary|Partial Remission|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria; The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.~Partial remission (PR). All of the criteria for CR had to be met, except that the bone marrow had to contain ≥ 5% but less than 25% blasts (or ≤ 50% of initial blast count), or < 5% blasts in the presence of Auer rods or abnormal morphology."|Data collected up to cut-off date 20 Oct 2011, Up to 1239 days|Treated set||participants|||Number
121256|NCT00632749|Secondary|Incidence of Dose Limiting Toxicity (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD)|up to 28 days of treatment|Treated set||participants|||Number
121257|NCT00632749|Secondary|Incidence and Intensity of AEs Graded According to CTCAE (Version 3.0)|"The severity and timing of AEs indicates how well the treatment regimen was tolerated.~Toxicities were evaluated using the common terminology criteria for adverse events (CTCAE) grading scheme."|Data from first treatment administration until cut-off date of 20 October 2011; up to 1239 days|Treated set||participants|||Number
121258|NCT00632749|Secondary|Response (Complete Remission [CR], Complete Remission With Incomplete Blood Count Recovery [CRi])|"Response to treatment was evaluated according to the following criteria (modified from the National Cancer Institute/Cancer and Leukemia Group B criteria:~The best overall response was defined as the best overall response recorded during the time period from the start of the treatment until the end of the treatment period, progression or death (whichever was earlier). Possible categories for best overall response were CR, CRi, Partial remission (PR), no change (NC), Progressive disease (PD) and no assessment.~Complete remission (CR): morphologically leukaemia free state (i.e. bone marrow with < 5% blasts by morphologic criteria and no Auer rods, no evidence of extramedullary leukaemia) and absolute neutrophil count ≥ 1,000/μL and platelets > 100,000/μL.~Complete remission with incomplete blood count recovery (“incomplete” CR, CRi).All of the above criteria for CR had to be met, except that neutrophils < 1,000/μL or platelets < 100,000/μL in the blood."|Data collected up to cut-off date 20Oct2011, Up to 1239 days|Treated set||participants|||Number
121259|NCT00632749|Primary|The Maximum Tolerated Dose (MTD) of 2 Schedules of BI 811283 in Combination With Cytarabine.|"The MTD was defined as the highest dose at which 6 patients were treated and less than 2 patients who experienced a dose limiting toxicities (DLT) within the first cycle of treatment.The MTD was defined based on safety data from the first cycle only.~It was determined using a standard “3 + 3 design with de-escalation”."|up to 28 days of treatment|Treated set (TS): All patients who received at least one single dose of trial medication (BI 811283 or cytarabine) were considered.||mg|||Number
121260|NCT00632736|Secondary|Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26|"The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day. Wk, Week."|Week 4 and Week 26|All participants enrolled into this study from parent study 101468/168 who received at least one dose of study medication. Only 74 participants completed this questionnaire at Week 4, whereas 87 participants completed this questionnaire at Week 26.||participants|||Number
121261|NCT00632736|Primary|Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.|13 February 2004 through 31 March 2010|Safety Population: all participants who received at least one dose of study medication||participants|||Number
121262|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.~Subscales:~CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|6-months follow-up|||units on a scale||Standard Deviation|Mean
121263|NCT00632632|Secondary|Structured Clinical Interview for DSM-IV - Major Depressive Disorder (SCID-MDD)|Structured Clinical Interview for DSM-IV - Major Depressive Disorder is a clinical interview to assess presence/absence of Major Depressive Disorder.|Immediately following treatment|||percentage of MDD remission|||Number
121264|NCT00632632|Primary|Clinician Administered PTSD Scale(CAPS)|"Total CAPS severity score range is 0-136. Higher values represent a worse outcome (i.e. greater severity of posttraumatic symptoms). CAPS consists of 3 subscales, which are combined to form a total severity score.~Subscales:~CAPS cluster B (reexperiencing symptoms, range 0-40) CAPS cluster C (avoidance and numbing symptoms, range 0-56) CAPS cluster D (hyperarousal symptoms, range 0-40)"|Immediately following treatment|||units on a scale||Standard Deviation|Mean
121265|NCT00632619|Secondary|Disruptive Behavior Disorder Scale Score for ODD Symptoms|parents rating all DSM symptoms of Oppositional Defiant Disorder on a 0-3 severity scale with higher scores indicating more severe symptoms and range is from 0-27 (8 DSM IV items and I item from DSM 3R)|week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
121266|NCT00632619|Secondary|Children's Depression Rating Scale-Revised (CDRS-R) Total Score|rates 17 items of depression on a severity scale using information obtained from parent and child. Higher numbers indicate more severity symptoms and range is from 17 to 113.|Measured at Week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
121268|NCT00632619|Primary|Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe|averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.|measured at week 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
121269|NCT00632619|Secondary|Young Mania Rating Scale (YMRS) Score|rates manic like symptoms in children; 7 items ranging from 0-4 and 4 items on a 0-8 scale; higher scores indicate more severe symptom severity (min total score=0, max=60). There are no subscales. Symptom severity information is obtained from direct interview of parent and child. It was initially selected as the primary outcome but prior to commencement of data collection the Mood Severity Index (MSI) was chosen instead based on recently published work in a related study (see above).|Measured at weeks 12 (endpoint)|all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.||units on a scale||Standard Deviation|Mean
121270|NCT00632541|Secondary|Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.||24 months||||||
121271|NCT00632541|Secondary|Assess the Overall Response Rate.||24 months||||||
121272|NCT00632541|Secondary|Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.||6 months||||||
121273|NCT00632541|Primary|Progression-Free Survival|The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer. Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.|From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months|||months||95% Confidence Interval|Median
121274|NCT00632502|Secondary|Maximum Plasma Concentration of Navarixin (Cmax)|Plasma samples were to be collected at baseline and up to 24 hours after dosing with navarixin at Weeks 1, 2, 3, and 4|Week 1, 2, 3, and 4|The analysis population was to include all participants who received at least one dose of navarixin and had navarixin plasma concentrations available for endpoint evaluation. The planned outcome measure was not evaluated.|||||
121275|NCT00632502|Secondary|Number of Participants Who Discontinued Treatment Because of an Adverse Event or a Protocol-defined Clinical Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. A protocol-defined clinical event is an asthma exacerbation requiring addition of or increase in systemic steroids, as determined by the investigator.|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
121276|NCT00632502|Secondary|Number of Participants Who Discontinued the Study Because of an Adverse Event|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
121277|NCT00632502|Secondary|Number of Participants With a Laboratory Adverse Event|The endpoint measured was any laboratory (hematology, blood chemistry, or urinalysis) abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
121278|NCT00632502|Secondary|Number of Participants With an Electrocardiogram Adverse Event|The endpoint measured was any electrocardiogram abnormality that was reported as an AE. An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Week 4|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
121279|NCT00632502|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 5 weeks|The analysis population included all participants who received at least one dose of study drug||Participants|||Number
121280|NCT00632502|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S])|The AQLQ[S] was administered at Baseline and at Weeks 2 and 4. The assessment consists of a 32-item questionnaire covering 4 domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation. Each item receives a score from 1 (worst, or most affected) to 7 (not at all affected). The score is the mean across all items, and ranges from 1 to 7. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint evaluation at Baseline or at any post-baseline visit||Score on a scale||Standard Deviation|Mean
121307|NCT00632203|Secondary|Number of Participants With Brain Metastases at First Progression|Brain Metastases were defined as radiological evidence of brain metastases on MRI.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.|||||
121281|NCT00632502|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Spirometry was used to measure post-bronchodilator FEV1 at Baseline and before study drug administration at Weeks 1, 2, 3, and 4. Participants received 4 puffs of bronchodilator (salbutamol hydrofluoroalkane or equivalent) at 30-second intervals and spirometry was performed 30 minutes later. The mean change from baseline is based on the average change over all post-baseline assessments.|Baseline and up to 4 weeks|The analysis population included all randomized participants who received at least one dose of study drug and had endpoint assessment at Baseline or at any post-baseline visit||Liters||Standard Deviation|Mean
121282|NCT00632502|Secondary|Mean Change From Baseline in Total Asthma Symptom Score|Total Asthma Symptom Score is the sum of individual symptoms of wheezing, coughing, and dyspnea assessed twice daily (morning and evening) and is recorded on a comment diary card. Each of the symptoms receives a daily score from 0 (none) to 3 (severe), averaged over the two daily assessments. The total score ranges from 0 to 9, with a lower score indicating less severe asthma symptoms.|Baseline and Weeks 1, 2, 3, and 4|The analysis population included all randomized participants who received at least one dose of study drug and had Asthma Symptom Scores evaluated at the time points reported||Score on a scale||Standard Deviation|Mean
121283|NCT00632502|Secondary|Mean Change From Baseline in Sputum Absolute Neutrophil Count|Induced sputum samples were obtained at Baseline and at Weeks 2 and 4 of the treatment period. Samples were collected before study drug administration using the nebulizer method and sent to a central laboratory for analysis. An average was taken over all post-baseline samples collected no later than one day after the last dose of study drug.|Baseline and while on study drug (up to 4 weeks)|The analysis population included all randomized participants who received at least one dose of study drug and had sputum absolute neutrophil counts at Baseline or Week 4||Neutrophil count X10^9/L||Standard Deviation|Mean
121284|NCT00632502|Primary|Number of Participants Who Maintained an Absolute Peripheral Blood Neutrophil Count >=1500/µL|Peripheral blood neutrophil counts were performed on Day 2 and Weeks 1, 2, 3, and 4 of the treatment period|Up to 4 weeks|The analysis population included all participants who received at least one dose of study drug||Number of participants|||Number
121285|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Panobinostat, twice weekly|18 months|||mg|||Number
121286|NCT00632489|Secondary|To Evaluate the Tolerability and Preliminary Efficacy of Established Doses of LBH589 and Capecitabine With Lapatinib in a Limited Number of Patients With HER2+ Breast Cancer||18 months||||||
121287|NCT00632489|Secondary|To Evaluate the Antitumor Activity of LBH589 in Combination With Capecitabine in Patients With Refractory and Advanced Tumors||18 months||||||
121288|NCT00632489|Primary|To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil|MTD for Capecitabine, BID|18 months|MTD Determination only for part I patients (per protocol)||mg/m2|||Number
121289|NCT00632463|Secondary|The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers||18 Days|||Participants|||Number
121290|NCT00632463|Secondary|Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.||Study day 33|||Participants|||Number
121291|NCT00632463|Primary|Circulating RI-001 Titer|The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.|Study day 18|||Fold Change||95% Confidence Interval|Mean
121292|NCT00632424|Secondary|Best Overall Response|Tumor assessment was performed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all clinical and radiological evidence of target lesions; Partial Response (PR) = at least 30% reduction in the sum of the longest diameter of all target lesions; Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of all target lesions; Stable Disease (SD) = neither PR nor PD criteria were met.|Tumor assessments performed on Day 1 of every other cycle of therapy, until disease progression or toxicity|All treated participants who received at least one dose of ixabepilone were evaluable for tumor response.||participants|||Number
121293|NCT00632424|Secondary|PK: Mean Plasma Concentration Of Ixabepilone By Nominal Collection Time|Pharmacokinetics (PK) of ixabepilone were derived from plasma concentration versus time data. Individual patient PK parameter values were derived by standard non-compartmental methods by a validated pharmacokinetic analysis program. PK parameters include Cmax (maximum plasma concentration), Cmin (minimum plasma concentration), Tmax (time of maximum plasma concentration), AUC (0-TAU) (area under the curve in one dosing interval), T-half (plasma half-life).|Time 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 12.5, 13, 14, 15, 16, 17, 18, 20, 48, 72, and 168 hours post dose|Number of Participants Analyzed =All participants who received any treatment with ixabepilone and had adequate concentration profiles, n=all participants who received ixabepilone and had adequate concentration profiles at the specified time point. Cmax, Cmin, Tmax, AUC (0-TAU), and T-half were not calculated.||ng/ml||Standard Deviation|Mean
121294|NCT00632424|Secondary|Maximum QTc Interval on Day 1 and Maximum Change From Baseline for QTc Interval|QTc interval was defined as the measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, corrected for heart rate|Baseline (Day -1) and Day 1|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, QTc data were collected but not analyzed.|||||
121295|NCT00632424|Secondary|Number Of Participants With Liver Function and Renal Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Clinical laboratory evaluations included liver function (alanine aminotransferase [ALT], Aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin), and renal function (creatinine).|From first study drug administration through 30 days post dose|Since study NCT00632424 (CA163-149) was discontinued early due to variability in oral ixabepilone concentrations with the potential to negatively impact both safety and efficacy, liver and renal laboratory data were collected but not summarized.|||||
121308|NCT00632203|Secondary|Overall Survival|The overall survival was analyzed using the Kaplan-Meier method.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up|||months||95% Confidence Interval|Median
121296|NCT00632424|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB).|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.||participants|||Number
121297|NCT00632424|Secondary|Number of Participants With Most Common Treatment-Related Nonhematologic AEs (>25%)|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.||participants|||Number
121298|NCT00632424|Secondary|Number of Participants With Adverse Event (AE), AE Leading to Discontinuation, Treatment-related AE, Treatment-related AE Leading to Discontinuation (DC), Most Common Treatment-Related Nonhematologic AE (>25%), Serious AE (SAE), or Treatment-related SAE|AEs graded according to Common Terminology Criteria Version 3.0 (CTC v 3.0). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From first study drug administration through 30 days post dose|All participants who received at least one dose of ixabepilone.||participants|||Number
121299|NCT00632424|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was defined as the maximum dose which could be given to 6 participants such that not more than 1 participant experienced a DLT (or fewer than one-third if there were more than 6 treated participants) with at least 2 participants experiencing a DLT at the next higher dose level. The R2PD was to be based on the MTD and the assessment of any relevant chronic toxicities.|At the end of Cycle 1 (21 days).|Due to early study discontinuation, the MTD and RP2D of oral ixabepilone at the scheduled doses used in this study were not determined|||||
121300|NCT00632424|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT)|DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) <500 cells/mm^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.|During Cycle 1 (Day 0 through Day 21)|All participants who received at least one dose of ixabepilone.||participants|||Number
121301|NCT00632281|Secondary|Toxicity ot the Thorax|"Toxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and late toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity"|up to 2 years, 9 months|||percentage of participants|||Number
121302|NCT00632281|Primary|Disease Status|2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)|2 yrs|44 lesions in 38 patients were treated with IMRT or 3D conformal beams on a prospective trial examining thoracic SBRT. Twenty-two of 32 primary lung cancer patients had biopsy-proven NSCLC (stage IA, 21 patients; stage IB, 11 patients). Six had metastatic disease. Six patients had 2 lesions treated simultaneously.||percentage of participants|||Number
121303|NCT00632229|Secondary|Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms|This assessment measures the overall severity of obsessive-compulsive symptoms. It consists of a single item that is completed by a clinician with scores ranging from 0-6 with higher scores corresponding with more severe obsessive-compulsive symptoms. Thus, higher scores represent a worse outcome.|post-treatment|Includes those subjects who were randomized to their respective condition.||Scores on a scale||Standard Deviation|Mean
121304|NCT00632229|Primary|Yale Brown Obsessive Compulsive Scale|This measure assesses obsessive-compulsive symptom severity across 10 items that are completed during an interview format with the person with OCD. These 10 items are summed to derive a total score, which ranges from 0-40 [Scale range: 0 (Minimum) - 40 (Maximum)] with higher scores corresponding to more severe obsessive-compulsive symptoms.|End of study (8 weeks)|||Scores on a scale||Standard Deviation|Mean
121305|NCT00632203|Secondary|Tolerability of Maintenance Temozolomide|Tolerability was defined as number of participants with any adverse event leading to study discontinuation and/or study drug discontinuation.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|||participants|||Number
121306|NCT00632203|Secondary|Cancer-related Quality of Life (QoL) as Assessed by The European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire C30 Version 3.0 (QLQ-C30), and the EORTC Lung Cancer Module (QLQ-LC13)|The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Scores range from 0 -100. For functional and global QoL scales, higher scores mean a better level of function. For symptom-oriented scales, a higher score means more severe symptoms and a decrease in QoL. The EORTC QLQ-LC13 is a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It has a score range 0-100 with higher scores representing an increase in symptoms.|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to the last time of follow-up (up to 6 cycles (168 days) of study treatment)|No analysis was performed due to study termination.|||||
121596|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score|Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Scores on a scale||Full Range|Mean
121309|NCT00632203|Secondary|Time to Progression|"The time to progression (per response evaluation criteria in solid tumors [RECIST]) was analyzed using the Kaplan-Meier method.~Definitions of response per RECIST:~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): A decrease of at least 30% in the sum of the longest~diameter of target lesions.~Progressive Disease (PD): An increase of at least 20% in the sum of the longest~diameter of target lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to progression or up to 6 cycles (168 days) of study treatment|||months||95% Confidence Interval|Median
121310|NCT00632203|Secondary|Time to Radiological Central Nervous System (CNS) Progression|"Defined as CNS progression as measured by MRI.~Time to CNS progression was analyzed using the Kaplan-Meier method."|from Cycle 1 Day 1 of Standard First Line Systemic Therapy to radiological progression or the last known CNS progression-free date|||months||95% Confidence Interval|Median
121311|NCT00632203|Primary|Number of Participants Who Had Brain Metastases|Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).|Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)|Evaluable population, defined as a participant who had at least one post-randomization MRI scan||participants|||Number
121312|NCT00632099|Primary|Cocaine Abstinence Based on Urine Toxicology Results|Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)|during last 3 weeks of the trial|||participants|||Number
121313|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.||µg/L||Full Range|Geometric Mean
121314|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. AUC data were not available in 3 elderly patients.||µg*h/L||Full Range|Geometric Mean
121315|NCT00631969|Secondary|Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.||μg/L||Full Range|Geometric Mean
121316|NCT00631969|Secondary|Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma|Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.|Visit 5 after 12 weeks of treatment|Pharmacokinetics (PK) were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. The PK data of one elderly patient were only evaluable for Cmax but not for AUC.||μg*h/L||Full Range|Geometric Mean
121317|NCT00631969|Secondary|Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale|Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of participants|||Number
121318|NCT00631969|Secondary|Satisfaction With Medication at Week 12 or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Satisfaction with medication” at LOCF expressed as the least square mean difference.|up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.||scores on a scale||Standard Deviation|Mean
121319|NCT00631969|Secondary|Change From Baseline in Confidence for Completion at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Confidence for completion” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
121320|NCT00631969|Secondary|Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Satisfaction with orgasm” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
121345|NCT00631696|Secondary|Change From Baseline in Testosterone to End of Study (EOS)|End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
121321|NCT00631969|Secondary|Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “ Pleasure of sexual activity” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
121322|NCT00631969|Secondary|Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “ Erectile function satisfaction” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
121323|NCT00631969|Secondary|Change From Baseline in Ease With Erection at 12 Weeks or LOCF|Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain “Ease with Erection” from baseline to Week 12 or LOCF expressed as the least square mean difference.|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
121324|NCT00631969|Secondary|Number of Sexual Attempts Till First Successful Attempt||up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||Sexual Attempts||Standard Deviation|Mean
121325|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of ejaculation successes||Standard Deviation|Mean
121326|NCT00631969|Secondary|Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of satisfactory attempts||Standard Deviation|Mean
121327|NCT00631969|Secondary|Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of satisfactory erections||Standard Deviation|Mean
121328|NCT00631969|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of successful erections||Standard Deviation|Mean
121329|NCT00631969|Secondary|"Percentage of Subjects Achieving Back to Normal Erectile Function"|Responders: percentage of subjects achieving an IIEF-EF score > 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of participants|||Number
121330|NCT00631969|Primary|Change From Baseline in Success of Erection Maintenance at 12 Weeks|SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of success in maintenance||Standard Deviation|Mean
121331|NCT00631969|Primary|Change in Percentage From Baseline in Success of Penetration at 12 Weeks|Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.|from baseline up to 12 weeks of treatment|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||percentage of successful penetrations||Standard Deviation|Mean
121332|NCT00631969|Primary|Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF|The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED').|from baseline up to 12 weeks|The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.||scores on a scale||Standard Deviation|Mean
121333|NCT00631917|Primary|Summary of the End of Study Colonoscopy Results|During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.||Percentage of Participants|||Number
121334|NCT00631917|Secondary|Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target|The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)|Weeks 8, 30 and End of Study (54 weeks)|Full analysis set||Percentage of Participants|||Number
121335|NCT00631917|Secondary|Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment|Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score > 0 is worsening from baseline in which the maximum possible score is 3.|54 weeks|Primary analysis set||participants|||Number
121336|NCT00631917|Secondary|Percentage of Participants With Each of the Individual Components of Colonic Pathology|Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary analysis set||Percentage of Participants|||Number
121337|NCT00631917|Primary|Percentage of Participants With Colonic Pathology|The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.|54 weeks|Primary Analysis Set, consisting of all randomized patients that had post-baseline colonoscopy procedure performed.||Percentage of participants|||Number
121338|NCT00631748|Secondary|Percentage of Participants Attaining Abstinence for Three Weeks|Abstinence was defined as a negative urine drug screen (UDS) (for cocaine) for three consecutive weeks of the trial measure at either time point Week 6 or Week 12|Abstinence defined as negative UDS for 3 consecutive weeks of the trial|At end of study (12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.||Percentage of Participants|||Number
121339|NCT00631748|Primary|Timeline Followback Interview (TLFB)|The primary outcome measure was the self-report of cocaine use in the past week, as assessed with a Timeline Followback Interview (TLFB). The TLFB is a questionnaire in which the subject is asked to self-report how much cocaine was used and how much money was spent on cocaine every day for the past 1-2 weeks.|Grams of cocaine used at end of study (12-weeks)|At end of study(12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.||grams of cocaine used||Standard Deviation|Mean
121340|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 12|Mean sperm motility (percent motility representing grade a+b) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 12 was average of last 2 values within window of 2 to 133 days from Study Day 1 and at least 1 of the 2 values was non-missing. If there was only 1 assessment date within the stated window, then Week 12 was the value of that single assessment. If all the values within the window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.||percent motility||Standard Deviation|Mean
121341|NCT00631696|Secondary|Change From Baseline in Sperm Motility to Week 26|Mean sperm motility (percent motility representing grade a+b) was the average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 26 was average of the last 2 values within window of 134 to 252 days from Study Day 1 and at least 1 of the 2 values was non-missing. If only 1 assessment date within the stated window, Week 26 was the value of that single assessment. If all values within window were missing, the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.||percent motility||Standard Deviation|Mean
121342|NCT00631696|Secondary|Change From Baseline in Sperm Motility to End of Study (EOS)|Mean sperm motility (percent motility representing grade a+b [a=sperm with progressive, straight-line motility; b=non-linear motility]) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|MITT; N=number of participants with analyzable data at observation; LOCF.||percent motility||Standard Deviation|Mean
121343|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 12|Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.||ng/dL||Standard Deviation|Mean
121344|NCT00631696|Secondary|Change From Baseline in Testosterone to Week 26|Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT; N=number of participants with analyzable data at observation.||ng/dL||Standard Deviation|Mean
121346|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.|Baseline, Week 12 (last observation in the Week 12 window)|MITT; N=number of participants with analyzable data at observation.||IU/L||Standard Deviation|Mean
121347|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26|FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.|Baseline, Week 26 (last observation in the Week 26 window)|MITT population; N=number of participants (observed cases) with analyzable data at observation.||IU/L||Standard Deviation|Mean
121348|NCT00631696|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)|FSH minimum normal range 1.4 International units per liter (IU/L) to maximum normal range 18.1 IU/L. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Modified intent-to-treat (MITT) population included all randomized participants who received at least 1 dose of study medication (either pregabalin or placebo) and were not discontinued for major violation at the site level. N=number of participants with analyzable data at observation; LOCF.||IU/L||Standard Deviation|Mean
121349|NCT00631696|Primary|Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)|Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. Confidence intervals (CI) based on exact distribution.|Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)|Per protocol analysis set: all randomized participants who had ≥8 weeks of study treatment, sperm concentration measurements at or after week 12 window, did not discontinue for site violations, and did not have any major protocol violations. N=number of participants with analyzable data at observation; Last observation carried forward (LOCF).||percentage of participants||95% Confidence Interval|Number
121350|NCT00631670|Secondary|Overall One Year Survival|Number of patients alive at one year after treatment|One year|||participants|||Number
121351|NCT00631670|Secondary|Pain Relief|Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.|12 weeks|Patients who reported pain at baseline||participants|||Number
121352|NCT00631670|Secondary|Neurologic Function|Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.|2 years|6 patients presented with tumor-related deficits before treatment.||participants|||Number
121353|NCT00631670|Secondary|Local Control|Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery|1 year|||tumors|Participants||Number
121354|NCT00631670|Primary|Toxicity|"Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as acute meaning during treatment and late meaning several months after treatment ended."|2 yrs|||participants|||Number
121355|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 7-Day Discontinuation Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 7-day Discontinuation Period to assess the effects of discontinuing treatment.|Baseline and End of 7-day Discontinuation Period|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a 7-Day Discontinuation Period IGR efficacy assessment.||score on a scale||Standard Deviation|Mean
121356|NCT00631657|Other Pre-specified|Change From Baseline in Investigator Global Rating (IGR) - 6-Month Treatment Period|The IGR is a clinician-rated 7-point scale used to assess the severity of illness. Severity is rated on a scale from 1=Normal to 7=Extremely severe. Baseline was defined as the last non-missing value obtained during the Placebo Run-in Period. IGR assessments were done at Baseline of the 6-Month Treatment Period and and at the end of the 6-Month Treatment Period to assess the effects of treatment.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 IGR efficacy assessment.||score on a scale||Standard Deviation|Mean
121369|NCT00631540|Secondary|Number of Participants With 9-month Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|9 Months|3 participants withdrew, 4 died, and 1 was lost to follow-up prior to 300 days.||Participants|||Number
121370|NCT00631540|Secondary|Number of Participants With 30-day Major Adverse Events|Clinical Events Committee Adjudicated Death, Clinical Events Committee Adjudicated Q-wave MI, Clinically-driven Target Lesion Revascularization, Clinical Events Committee Adjudicated Significant Embolic Events.|30 Days|1 participant withdrew and 1 participant was lost to follow-up prior to 30 days.||Participants|||Number
121357|NCT00631657|Other Pre-specified|Change From Baseline in Two Aggregate Measures of Short Form 36 (SF-36) Health Survey Score - 6-Month Treatment Period|SF-36 is a participant-rated questionnaire that consists of 8 scaled scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each of the 8 questions carries equal weight. The SF-36 can be divided into 2 aggregate summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The scores can range from 0 to 100, with a lower score indicating more disability. Baseline was defined as the SF-36 score assessed at randomization.|Baseline and Week 26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and a Week 26 SF-36 efficacy assessment.||score on a scale||Standard Deviation|Mean
121358|NCT00631657|Other Pre-specified|Change From Baseline in Satisfaction With Sleep Duration - 6-Month Treatment Period|"Satifaction with Sleep Duration was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 8 How satisfied are you about your sleep duration of last night?, as reported by participants using a LogPad. Responses could range from 0=Very unsatisfied to 100=Fully satisfied, with a higher score indicating great satisfaction with sleep duration. Baseline was defined as the mean Satisfaction with Sleep Duration score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Satisfaction with Sleep Duration efficacy assessment.||score on a scale||Standard Deviation|Mean
121359|NCT00631657|Other Pre-specified|Change From Baseline in Sleep Quality - 6-Month Treatment Period|"Sleep Quality was assessed using a Visual Analog Scale (VAS) in response to the sleep diary question 7 Rate the quality of your sleep last night, as reported by participants using a LogPad. Responses could range from 0=Very poor to 100=Excellent, with a higher score indicating greater sleep quality. Baseline was defined as the mean Sleep Quality score from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline Sleep Quality efficacy assessment.||score on a scale||Standard Deviation|Mean
121360|NCT00631657|Other Pre-specified|Change From Baseline in Number of Awakenings (NAW) - 6-Month Treatment Period|"NAW was defined as the number of times recorded for sleep diary question 4a How many times did you wake up during the night?, as reported by participants using a LogPad. Baseline was defined as the mean NAW from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline NAW efficacy assessment.||number of awakenings||Standard Deviation|Mean
121361|NCT00631657|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO) - 6-Month Treatment Period|"WASO was defined as the time recorded for sleep diary question 5 How much time were you awake, after falling asleep initially?, as reported by participants using a LogPad. Baseline was defined as the mean WASO from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline WASO efficacy assessment.||minutes||Standard Deviation|Mean
121362|NCT00631657|Secondary|Change From Baseline in Sleep Latency (SL) - 6-Month Treatment Period|"SL was defined as the time recorded for sleep diary question 3 How long did it take you to fall asllep?, as reported by participants using a LogPad. Baseline was defined as the mean SL from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using an LOCF approach."|Baseline and the Mean of Weeks 14-26|The ITT population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline SL efficacy assessment.||minutes||Standard Deviation|Mean
121363|NCT00631657|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who discontinued study drug due to an AE is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 27 weeks|The AST population consisted of all participants who received at least one dose of any study drug.||participants|||Number
121364|NCT00631657|Secondary|Number of Participants Who Experienced Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function or chemistry of the body whether or not considered related to study drug. The number of participants who experienced AEs is combined for the 6-Month Treatment Period and the 7-Day Discontinuation Period.|Up to 31 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of any study drug.||participants|||Number
121365|NCT00631657|Primary|Change From Baseline in Total Sleep Time (TST) - 6-Month Treatment Period|"TST was defined as the time recorded for sleep diary question 6 How much time did you actually spend sleeping? as reported by participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the mean TST from the Placebo Run-in Period. Change from Baseline was calculated as the mean of combined data from Weeks 14 through 26, using a last observation carried forward (LOCF) approach."|Baseline and the Mean of Weeks 14-26|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had a baseline and at least one postbaseline TST efficacy assessment.||minutes||Standard Deviation|Mean
121366|NCT00631540|Secondary|30-day Clinical Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events within 30 days.|30 Days|1 participant was lost to follow-up, 1 participant withdrew, 1 participant did not have core lab assessment.||Percentage of Participants|||Number
121367|NCT00631540|Secondary|Acute Procedural Success|< 30% residual stenosis post-procedure by core lab analysis and no Major Adverse Events before discharge.|Prior to Discharge|1 participant did not have core lab assessment for stenosis.||Percentage of Participants|||Number
121368|NCT00631540|Secondary|Technical Success|Successful delivery and deployment of a Formula™ Balloon-Expandable Stent at index procedure.|Prior to Discharge|||Percentage of Participants|||Number
121372|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC|GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||pmole*h/L||Standard Error|Least Squares Mean
121373|NCT00631488|Secondary|Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC|Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.|BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||pmol*h/L||Standard Error|Least Squares Mean
121374|NCT00631488|Secondary|Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||mg.h/dL||Standard Error|Least Squares Mean
121375|NCT00631488|Secondary|Change From BL to Week 4 in Fasting Plasma Glucose (FPG)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||mg/dL||Standard Error|Least Squares Mean
121376|NCT00631488|Primary|Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population||mg/dL||Standard Error|Least Squares Mean
121377|NCT00631475|Secondary|Occurrence of Liver Function Test (LFT: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)) Abnormality.|Number of participants with an increase in ALT and/or AST to > 3 times upper limit of normal during the study.|up to 21 months, plus 24 hours after the end of study treatment|Study population||participants|||Number
121378|NCT00631475|Secondary|Treatment-emergent Serious Adverse Events (SAE)|Number of participants with at least one SAE during the study.|up to 21 months plus 28 days after the end of study drug|Study population||participants|||Number
121379|NCT00631475|Secondary|Adverse Events (AE) Leading to Discontinuation of Study Drug.|Number of participants with at least one AE that led to permanent discontinuation of study treatment.|Start to end of study, up to 21 months|Study population||participants|||Number
121380|NCT00631475|Secondary|Number of Patients Exposed to Bosentan Over Time|Numbers of participants exposed to bosentan treatment over time|Start to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of OL treatment, respectively.||Participants|||Number
121381|NCT00631475|Primary|Extent of Exposure to Bosentan in Patients With Idiopathic Pulmonary Fibrosis (IPF)|Mean extent of exposure to bosentan treatment in months|Start of study to end of study, up to 21 months|For two patients, the exact treatment stop date was missing and the duration could not be calculated, but these patients received at least 345 and 127 days of open label (OL) treatment.||months||Standard Deviation|Mean
121382|NCT00631449|Secondary|Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) Will be Assessed as a Secondary Outcome.||Week 24||||||
121383|NCT00631449|Primary|We Will Use as Our Primary Endpoint the Proportion of Subjects in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.||Week 12|||participants|||Number
121384|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm B|Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period”n”: Cycle (n-1)*2+1 to n*2.|Up to 384 days (the last subject study discontinuation in the Treatment Arm B)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.||percent of total planned dose||Standard Deviation|Mean
121385|NCT00631410|Secondary|Sunitinib Relative Dose Intensity in the Treatment Arm A|Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period”n”: Cycle (n-1)*3+1 to n*3.|Up to 733 days (the last subject study discontinuation in the Treatment Arm A)|All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.||percent of total planned dose||Standard Deviation|Mean
121386|NCT00631410|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.||days||Full Range|Median
121387|NCT00631410|Secondary|Duration of Response (DR)|Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.|Up to 733 days (the last subject study discontinuation)|Summary statistics were not calculated due to a small number of subjects.||days||Full Range|Median
121388|NCT00631410|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.|Up to the last subject completed Cycle 24 or individual study discontinuation|All enrolled subjects who 1) had a diagnosis of locally-advanced or metastatic adenocarcinoma of the colon or rectum with measurable disease at baseline; 2) had received at least one dose of the investigational product; and 3) with efficacy data available after administration of the investigational product.||participants|||Number
121389|NCT00631410|Secondary|Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.||nanogram per milliliter||Full Range|Median
121390|NCT00631410|Secondary|Plasma Concentration of Sunitinib Active Metabolite (SU012662)|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.||nanogram per milliliter||Full Range|Median
121391|NCT00631410|Secondary|Plasma Concentration of Sunitinib|Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.|Cycle 1 Day 14 and Cycle 2 Day 1|Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.||nanogram per milliliter||Full Range|Median
121392|NCT00631410|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.|Up to 733 days (the last subject study discontinuation)|All subjects who received at least 1 dose of the study drug.||participants|||Number
121393|NCT00631371|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.||months||95% Confidence Interval|Median
121394|NCT00631371|Secondary|Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.||percentage of participants||95% Confidence Interval|Number
121395|NCT00631371|Secondary|Progression-Free Survival (PFS): Investigator-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|ITT population included all participants who were randomized to the study.||months||95% Confidence Interval|Median
121396|NCT00631371|Primary|Progression-Free Survival (PFS): Independent-Assessment|PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.|Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)|Intent-to-treat (ITT) population included all participants who were randomized to the study.||months||95% Confidence Interval|Median
121397|NCT00631358|Secondary|Correlation Between Biomarker Expression and the Schirmer Test|Correlation factor: TNFmRNA vs. Schirmer|Baseline to 2 weeks|||Correlation Factor|||Number
121398|NCT00631358|Secondary|Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining|"Correlation factor:~TNFmRNA vs. NaFl staining"|Baseline to 2 weeks|No data available for the no treatment group.||Correlation factor|||Number
121399|NCT00631358|Secondary|Correlation Between Biomarker Expression and Tear Film Break up Time|"Correlation factor:~TNFmRNA vs. TFBUT (Tear Film Break-up Time)"|Baseline to 2 weeks|||Correlation factor|||Number
121400|NCT00631358|Secondary|Correlation Between Biomarker Expression and Ocular Symptoms|Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).|Baseline to 2 weeks|||Correlation factor|||Number
121401|NCT00631358|Primary|Change in Levels of Biomarkers After Dosing With Maxidex|Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.|Baseline to 2 weeks|||ddCt (Delta-Delta-Ct)||Standard Deviation|Mean
121402|NCT00631189|Secondary|To Evaluate Clinical and Laboratory Safety|Serious Adverse Event and Adverse Event reported throughout the study|duration of study|||Adverse Events|||Number
121403|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the European Atherosclerosis Society (EAS) Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data.|||||||
121404|NCT00631189|Secondary|Compare the Numbers of Patients Achieving the LDL-C Goal According to the National Cholesterol Education Program Adult Treatment Panel III (NCEP) ATP III) Guidelines for the Management of Dyslipidaemic Patients|To Compare numbers of patients achieving the LDL-C goal according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP). As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data. The percentage of patients achieving the NCEP-ATP III LDL-C goal. ATP III is categorized into 3 risk categories:(1) established CHD and CHD risk equivalents(2) multiple risk factors(3) zero to one (0–1) risk factor|from baseline and after 8 weeks of treatment|||Participants|||Number
125636|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Dermatological’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
121405|NCT00631189|Secondary|Compare the Percentage of Variation of Phospholipase A2 (PLA2)|To Compare the percentage of variation of phospholipase A2 (PLA2) taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment|||percent of variation of phospholipase A2||Standard Deviation|Mean
121406|NCT00631189|Secondary|Compare the Percentage of Variation of C-reactive Protein (CRP)|To compare the percentage of variation of C-reactive protein (CRP) taking baseline values as reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment|||percent of variation of C-reactive prot.||Standard Deviation|Mean
121407|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Apolipoprotein B/Apolipoprotein A1 Ratio and After 8 Weeks of Treatment|To Compare the percentage of variation from baseline Apolipoprotein B/Apolipoprotein A1 ratio and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|baseline and after 8 weeks of treatment|||percent. Apolipoprotein B/A1 decrease||Standard Deviation|Mean
121408|NCT00631189|Secondary|Compare the Percentage of Variation From Baseline Triglycerides Values and After 8 Weeks|To compare the percentage of variation from baseline triglycerides values and after 8 weeks. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Baseline and after 8 weeks of treatment|||percentage of triglycerides decrease||Standard Deviation|Mean
121409|NCT00631189|Secondary|Compare the Percentage of HDL-C (High Density Lipoprotein Cholesterol) Variation From Baseline and After 8 Weeks of Treatment|Compare the percentage of HDL-C (High Density Lipoprotein Cholesterol) variation taking baseline value as a reference and after 8 weeks of treatment. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|After 8 weeks of treatment|||percentage of HDL-C increase||Standard Deviation|Mean
121410|NCT00631189|Secondary|Compare the Percentage of Total Cholesterol Variation From Baseline and After 8 Weeks of Treatment|To compare the percentage of total cholesterol variation taking baseline value as a reference. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|from baseline and after 8 weeks of treatment|||percentage of total cholesterol decrease||Standard Deviation|Mean
121411|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the LDL-C Goal, in Relation to the Number of Risk Factors, According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done||||||
121412|NCT00631189|Secondary|To Compare the Percentage of Patients Reaching the Overall LDL-C Goal According to the French Agency for the Safety of Health Products (AFSSAPS) 2005 Guidelines for the Management of Dyslipidaemic Patients|Not done. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Not done||||||
121413|NCT00631189|Primary|Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks|To compare the percentages of LDL-C level variation. As the recruitment target was not reached at the date initially planned, and in view of the recruitment difficulties, AstraZeneca decided not to extend the patient recruitment period and to perform only a descriptive analysis of the data|Change from baseline and after 8 weeks of treatment|92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group||percentage of LDL-C decrease||Standard Deviation|Mean
121414|NCT00631020|Secondary|Change in Number of Cigarettes/Day During the Past 7-days Compared to Baseline|Change from baseline self report of number of cigarettes per day compared to the past 7 days at each time point.|Weeks 6, 12, 16 and 24|||cigarettes/day||Standard Deviation|Mean
121415|NCT00631020|Secondary|Change in Tobacco Dependence Compared to Baseline|Tobacco dependence was measured using the Cigarette Dependence Scale (CDS-12). The CDS-12 scale is a 12-item scale that assesses some components of formal diagnostic systems' (e.g., DSM-IV and ICD-10) definitions of dependence with an emphasis on compulsion to smoke, withdrawal, loss of control, time allocation, neglect of other activities, and persistence despite harm. Response choices are on a five-point Likert scale to measure dependence (low =1; high = 5), the total score is the sum of all 12 items with a score range of 12 - 60. The change in scores from baseline at each time point were measured.|Weeks 6, 12, 16 and 24|||units on a scale||Standard Deviation|Mean
121416|NCT00631020|Secondary|Changes in Tobacco Withdrawal Symptoms Compared to Baseline|Tobacco withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS). Eight withdrawal symptoms are each rated for their severity on a scale from 0 (not present) to 4 (severe) for the past week and summed to calculate a total score at each time point, with a score range of 0-32. The average change from baseline for all participants at the specified time points were determined.|Weeks 6, 12, 16 and 24|||units on a scale||Standard Deviation|Mean
121417|NCT00631020|Primary|7-day Smoking Abstinence at End of Treatment (Week 6) and at Follow-up Visits (Weeks 12, 16, 24)|The primary index of smoking behavior will be subject’s self-report of smoking using a diary method for the past 7 days prior to the assessment. The subject self-report will be supplemented by: expired CO and by urine cotinine concentrations. Abstinence (yes/no) will be defined as no cigarettes during the past 7 days and an expired CO of <=8 ppm.|week 6, 12, 16 and 24|||participants|||Number
121418|NCT00631020|Primary|Retention in Trial|Retention in trial is defined as completing the 6-week intervention (attended week6, yes/no)|week 6|||participants|||Number
121420|NCT00631007|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.|The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.||mg/dL||Standard Deviation|Mean
121421|NCT00631007|Primary|Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward|HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent|Weeks 0-24|Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.||Percernt||Standard Deviation|Mean
121422|NCT00630994|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Adverse events were assessed every cycle during treatment.|Up to 48 weeks|||participants|||Number
121423|NCT00630994|Secondary|Number of Participants With Constitutional Symptoms|Constitutional symptoms including the presence of one or more of the following felt to be attributed to the disease: severe night sweats, fevers, weight loss and bone pain. Symptoms were assessed every cycle during treatment.|Up to 48 weeks|Study terminated prematurely. Analysis not performed.|||||
121424|NCT00630994|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to progression of disease or death due to any cause.~Progression was defined as any one or more of the following:~1)progressive splenomegaly; 2) leukemic transformation confirmed by a bone marrow blast count of >= 20%; 3) an increase in peripheral blood blast percentage of >=20% that lasts for >= 8 weeks."|up to 3 years|Study terminated prematurely. Analysis not performed.|||||
121425|NCT00630994|Secondary|Overall Survival(OS)|OS was defined as the time from registration to death of any cause.|up to 3 years|Study terminated prematurely. Analysis not performed.|||||
121426|NCT00630994|Primary|Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.|"Confirmed response: objective status of CR, PR, or CI on 2 consecutive evaluations >=4 weeks apart.~CR:Complete resolution of disease-related symptoms and signs; peripheral blood count remission; normal leukocyte differential; bone marrow histologic remission.~PR: All criteria for CR except the bone marrow histologic remission. CI: one of the following in the absence of both disease progression and CR/PR: minimum (MI) 20-g/L increase (INC) in hemoglobin level; MI 50% reduction in palpable splenomegaly (>=10cm); MI 100% INC in platelet count(>=50000x10^9/L) or ANC (>=0.5x10^9/L)"|Every 4 weeks during treatment (up to 16 weeks)|All participants who met the eligibility criteria that have signed a consent form and went on treatment were evaluable for response. The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution.||participants|||Number
121427|NCT00630955|Primary|Baseline-adjusted Craving (YCS)|Craving for alcohol based on Yale Craving Scale, scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7.|Day 7|||millimeters||Standard Error|Least Squares Mean
121428|NCT00630955|Secondary|Stimulation and Sedation Responses to Alcohol||Day 7||||||
121429|NCT00630955|Primary|Number of Drinks Consumed on Day 7||Day 7|||standard drinks||Standard Deviation|Mean
121430|NCT00630916|Secondary|Aortic Valve Regurgitation|Measure the level of aortic insufficiency (severity of backflow) in the Mitroflow valve.|12 months|||Percent of participants|||Number
121431|NCT00630916|Primary|Effective Orifice Area|Effective orifice area of the Mitroflow pericardial aortic valve measured via echocardiography to assess physiological area of blood flow through the prosthetic valve for each valve size.|12 months|||cm^2||Standard Deviation|Mean
121432|NCT00630916|Primary|Mean Gradient|Mean pressure across the Mitroflow aortic pericardial valve measured via echocardiography to assess ease of blood flow through the prosthetic valve for each valve size.|12 months|Patients with 12 month hemodynamic evaluations||mmHg||Standard Deviation|Mean
121433|NCT00630916|Primary|Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair|Hazard rate calculated as the number of adverse events divided by the total follow-up in years. Calculation is based on cumulative events and follow-up occurring >30 days after valve implant.|Late postoperative|Cumulative follow-up in years occurring post 30 days||Percent occurrence per patient-year|Participants|95% Confidence Interval|Mean
121434|NCT00630877|Primary|FAST Responsiveness--maximum Flushing Severity Score|The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.||Units on a scale|||Number
121435|NCT00630877|Primary|FAST Responsiveness--mean Flushing Severity Score|The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.|Study start to Day 43|Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.||Units on a scale|||Number
121458|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial Volume at Month 6, Month 12|Left atrial volume was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||cubic centimeter (cc)||Standard Deviation|Mean
121436|NCT00630877|Primary|FAST Longitudinal Construct Validity--maximum Flushing Severity Score|The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
121437|NCT00630877|Primary|FAST Longitudinal Construct Validity--mean Flushing Severity Score|The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).|Week 1 to Week 2|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
121438|NCT00630877|Primary|FAST Cross-sectional Construct Validity--maximum Flushing Severity Score|The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
121439|NCT00630877|Primary|FAST Cross-sectional Construct Validity--mean Flushing Severity Score|The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.|Week 1|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Spearman correlation coefficient|||Number
121440|NCT00630877|Primary|FAST Test-retest Reliability--maximum Flushing Severity Score|Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.||Intraclass correlation coefficient|||Number
121441|NCT00630877|Secondary|Maximum Severity of Flushing Events Overall During the Study|The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.|Week 1 to Week 6|m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.||Percentage of subjects|||Number
121442|NCT00630877|Primary|Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score|Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.|Week 1 to Week 2|Subjects with stable flushing symptoms from Week 1 to Week 2.||Intraclass correlation coefficient|||Number
121443|NCT00630864|Other Pre-specified|Change From Baseline in Troponin I Levels at Week 2, Week 6 , Month 3, Month 6, Month 12|Troponin I is a cardiac injury biomarker. Higher concentrations of this marker in blood are associated with heart injury.|Baseline, Week 2, Week 6 , Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.||nanogram/mL||Standard Deviation|Mean
121444|NCT00630864|Other Pre-specified|Change From Baseline in Karnofsky Performance Status Scale at Month 6, Month 12|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
121445|NCT00630864|Other Pre-specified|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) at Week 2, Week 6, Month 3, Month 6, Month 12|NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 2, Week 6, Month 3, Month 6, Month 12|ITT population. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category. Data prior Month 6 were not anticipated to be informative hence were not analyzed.||picogram/mL (pg/mL)||Standard Deviation|Mean
121446|NCT00630864|Other Pre-specified|Change From Baseline in Left Atrial (LA) Volume Index at Month 6, Month 12|LA volume index (LAVI), was the value of LA volume divided by body surface area, to measure LA size.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||milliliter/square meter (mL/m^2)||Standard Deviation|Mean
121478|NCT00630838|Primary|Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).|The primary outcome measure is reporting the number of participants diagnosed with Hirschsprung-associated enterocolitis (HAEC) after pullthrough procedure.|6 months post-pullthrough|||participants|||Number
121447|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Mass/Voltage Ratio at Month 6, Month 12|LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. QRS score (the sum of QRS voltages in the peripheral leads) was used as an index of “electrical” LV mass.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||gram/millivolt||Standard Deviation|Mean
121448|NCT00630864|Other Pre-specified|Change From Baseline in e:e’ Lateral Ratio , Ratio of Peak Mitral Early Diastolic and Atrial Contraction Velocity (E/A Ratio) at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Ratio of early (E) diastolic transmitral flow velocity and atrial (A) contraction velocity (E/A) and ratio of the early (E) diastolic transmitral flow velocity to the mitral annular velocity (e’) (E/e’) were estimated.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||ratio||Standard Deviation|Mean
121449|NCT00630864|Other Pre-specified|Change From Baseline in Doppler Data at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. Doppler principle was used to measure the mitral peak early (E) diastolic transmitral flow, mitral peak atrial (A) contraction velocity and annular velocities at the lateral and septal areas of the mitral annulus. s': systolic velocity during ejection, e': early diastolic mitral annular velocity, a': late diastolic mitral annular velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||centimeter per second (cm/sec)||Standard Deviation|Mean
121450|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Pulmonary Artery Systolic Pressure (PASP) at Month 6, Month 12|Systolic right ventricular pressure can be estimated on echocardiography by adding right atrial pressure (RAP) to the trans-tricuspid gradient derived from the tricuspid regurgitation velocity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||millimeter of mercury (mmHg)||Standard Deviation|Mean
121451|NCT00630864|Other Pre-specified|Change From Baseline in Tricuspid Peak Velocity at Month 6, Month 12|Tricuspid peak velocity was measured by echocardiography.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||meter per second (m/sec)||Standard Deviation|Mean
121452|NCT00630864|Other Pre-specified|Change From Baseline in Aortic Annulus Diameter at Month 6, Month 12|The diameter at the base of the aortic root, the basal ring, is also called the aortic annulus diameter.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||centimeter (cm)||Standard Deviation|Mean
121453|NCT00630864|Other Pre-specified|Change From Baseline in Isovolumetric Relaxation Time (IVRT), Mitral Deceleration Time at Month 6, Month 12|Doppler echocardiography was a procedure which used ultrasound technology to examine the heart. IVRT is the time between the closure of the aortic valve and the opening of the mitral valve. Mitral deceleration time (MDT) was the time taken from the maximum E point wave to baseline. E wave arises due to early diastolic filling.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||msec||Standard Deviation|Mean
121454|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular Mass (LVM) at Month 6, Month 12|LV mass was calculated from the product of the myocardial volume and specific gravity of heart muscle, estimated by echocardiography. Increased LVM was associated with cardiovascular morbidity and mortality.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||gram||Standard Deviation|Mean
121455|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) Ejection Fraction at Month 6, Month 12|Cardiac MRI was done to measure left ventricular ejection fraction (LVEF) which was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||percentage of EDV||Standard Deviation|Mean
121456|NCT00630864|Other Pre-specified|Change From Baseline in Fractional Shortening at Month 6, Month 12|Fractional shortening (FS) is the fraction of any diastolic dimension that is lost in systole. Percent of FS was calculated as difference between end-diastolic dimension (EDD) and end-systolic dimension (EDS) divided by EDD.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||percentage of EDD||Standard Deviation|Mean
121457|NCT00630864|Other Pre-specified|Change From Baseline in Left Ventricular (LV) End Systolic Volume, Left Ventricle (LV) Stroke Volume at Month 6, Month 12|Cardiac MRI was done to measure left ventricular (LV) end systolic volume, left ventricle (LV) stroke volume.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||milliliter (mL)||Standard Deviation|Mean
121597|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Scores on a scale||Full Range|Mean
121459|NCT00630864|Other Pre-specified|Change From Baseline in Echocardiography (ECHO) Parameters at Month 6, Month 12|Echocardiography was used to measure interventricular septal thickness (IVST), posterior left ventricular wall thickness (PLVWT), right ventricular wall thickness (RVWT), left atrial diameter (LAD): anterior-posterior (ant-post), medio-lateral, superior-inferior (sup-inf) and left ventricular end diastolic diameter (LVED), relative LV wall thickness (RLVWT).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||millimeter (mm)||Standard Deviation|Mean
121460|NCT00630864|Other Pre-specified|Change From Baseline in Overall Quality of Life and Individual Domains of the Short-form-36 (SF-36) at Month 6, Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health and two total scores (physical component summary [PCS] and mental component summary [MCS]. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
121461|NCT00630864|Other Pre-specified|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, Month 12|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). mBMI was calculated by multiplying BMI by serum albumin levels [gram/liter (g/L)]. mBMI was measured as kg/m^2*g/L. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||kg/m^2*g/L||Standard Deviation|Mean
121462|NCT00630864|Other Pre-specified|Change From Baseline in Heart Rate Response to Deep Breathing (HRDB) at Month 6 and Month 12|HRDB test was used to evaluate the cardio-vagal response. Participant took a series of 8 deep breaths and average heart rate difference was measured and compared to normative data. The main factor affecting HRDB is age, with older patients showing less heart rate variability. R-R (time between two consecutive R waves in the electrocardiogram) response to deep breathing was reported as the normal deviates (Z-score), the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were analyzed for the specific category.||Z-score||Standard Deviation|Mean
121463|NCT00630864|Other Pre-specified|Change From Baseline in Nerve Conduction Studies (NCS) at Month 6, Month 12|NCS: quantitative measures of peripheral nerve dysfunction consists of 5 attributes: peroneal nerve (PN) motor distal latency, PN compound muscle action potential, PN motor conduction velocity, tibial nerve distal motor latency, sural nerve sensory nerve action potential. Normal deviates (Z-score) summated into composite score (higher score=worsened nerve fiber function). Z-score is the defined position of the result in normal probability distribution with a mean of 0 and standard deviation (std) of 1 and describes how far a score is (in std) from the mean.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||Z-score||Standard Deviation|Mean
121464|NCT00630864|Other Pre-specified|Change From Baseline in Norfolk Quality of Life – Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, Month 12|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7: scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale:0=no problem, 4=severe problem(except item 32: -2=much better, 0=about same, 2=much worse).Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptom(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12);higher score=greater impairment, for each. Total score=-2 to 138 (higher score=worse QOL).|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
121465|NCT00630864|Other Pre-specified|Change From Baseline in Total Quality of Life (TQOL) Score at Month 6, Month 12|TQOL= sum of all Norfolk Quality of Life–Diabetic Neuropathy (Norfolk QOL-DN) items,a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on QOL of participants with DN; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). Total TQOL score=-2 to 138;higher score=worse quality of life.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
121466|NCT00630864|Other Pre-specified|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6, Month 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than [<] 2) in Neuropathy Impairment Score- Lower Limb (NIS-LL) score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, Month 12|Data on NIS-LL was reported in individual participant listings but responder status was not statistically summarized.|||||
121479|NCT00630825|Secondary|Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).|Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
121467|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score-Lower Limb (NIS-LL) at Month 6, Month 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0 to 4 scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
121468|NCT00630864|Other Pre-specified|Change From Baseline in the Neuropathy Impairment Score (NIS) at Month 6, Month 12|NIS assessed cranial nerves(nerve 3,6; facial, palate and tongue weakness),muscle weakness (respiratory; neck, elbow(E), wrist(W), finger(F), hip, knee(K) flexion; shoulder, thumb abduction; brachioradialis; E, W, hip, K extension; F spread; toe, dorsal and plantar ankle flexors; toe extensors); score: 0-4, higher score=more weakness, reflexes(biceps and triceps brachii; brachioradialis; quadriceps femoris; triceps surae), index F and great toe sensation(touch pressure, pin-prick, vibration, joint position)score:0=normal,1=decreased or 2=absent. Total score=0-244, higher score=more impairment.|Baseline, Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were analyzed for the specific category.||units on a scale||Standard Deviation|Mean
121469|NCT00630864|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events||Baseline up to Month 12|ITT population included all participants who received at least 1 dose of study medication.||participants|||Number
121470|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Holter Monitoring Findings|Holter monitoring recorded heart rhythm. Holter monitoring abnormality criteria: any abnormality, atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (VT), sustained VT and sinus pause.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.||participants|||Number
121471|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|ECG: investigator assessed test to assess cardiac function. ECG abnormality criteria: any abnormality, arrhythmia, rhythm, conduction, morphology, myocardial infarction, ST segment, T waves and abnormal U waves.|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.||participants|||Number
121472|NCT00630864|Other Pre-specified|Number of Participants With Clinically Significant Treatment-Emergent Echocardiography (ECHO) Findings|ECHO: investigator assessed test to assess cardiac function. ECHO abnormality criteria: any abnormality, valvular abnormality, pericardial effusion, abnormal regional wall motion, inferior vena cava respiratory variation, posterior (P) left ventricular (LV) wall/septal (S) thickness, right ventricular thickness, ejection fraction, ratio of early (E) diastolic transmitral flow and atrial(A) contraction velocity (E/A), ratio of ‘E’to lateral/septal mitral annular velocity (e') (E/e'prime lateral, E/e'prime septal), E deceleration time (DT), isovolumic relaxation time (IVRT).|Day 1 up to Month 12|ITT population. The ‘n’ for any post-dose incidence included participants with baseline values that were not abnormal (that is treatment-emergent abnormalities). Abnormalities at early termination were excluded from the analysis.||participants|||Number
121473|NCT00630864|Other Pre-specified|Number of Participants With Greater Than or Equal to Grade 3 Treatment-Emergent Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. On the basis of intensity, grade 3 was referred as severe, grade 4 as life-threatening and grade 5 as death.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.||participants|||Number
121474|NCT00630864|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose|ITT population included all participants who received at least 1 dose of study medication.||participants|||Number
121475|NCT00630864|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Month 6 and 12|TTR tetramer was assessed using a validated immunoturbidimetric assay. The FOI is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, Month 12|ITT population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
121476|NCT00630864|Primary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Week 6|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 6|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
121477|NCT00630838|Primary|Severity of Clinical Episodes of HAEC|The severity of clinical episodes of HAEC will be stratified into three grades (mild, moderate, or severe). Grades of severity reported are based on first episodes.|6 months|||participants|||Number
121480|NCT00630825|Secondary|Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.|Baseline and 4 and 8 and 16 weeks|The items in the Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. Therefore, no participants were analyzed for validation purposes.|||||
121481|NCT00630825|Secondary|Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire|The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6–point scale ranging from 1 “completely dissatisfied” to 6 “completely satisfied”; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 “all of the time” to 4 “none of the time”; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 “all of the time” to 4 “none of the time.” These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.|Baseline and 4 and 8 and 16 weeks|Participants in the per-protocol population with evaluable PAM-D-S questionnaire data. The per-protocol population consisted of participants who received at least one dose of study medication, had no significant protocol violations, completed the double-blind treatment phase, and were compliant with the study drug.||percentage of participants|||Number
121482|NCT00630825|Secondary|Change From Baseline in Lipids|Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable lipid data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Full Range|Median
121483|NCT00630825|Secondary|Rate of Hypoglycemia Per 30 Days|Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.||events per participant per 30 days||Standard Deviation|Mean
121484|NCT00630825|Secondary|Number of Participants With a Hypoglycemic Event|A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo.||participants|||Number
121485|NCT00630825|Secondary|Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores|Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Gastroparesis Cardinal Symptom Index (GCSI) questionnaire data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||units on a scale||Standard Deviation|Mean
121486|NCT00630825|Secondary|Nausea and Dyspepsia Measured by Visual Analog Scale|Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.|One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits|Participants who received at least one dose of LY2189265 or Placebo with evaluable nausea or dyspepsia (abdominal pain and bloating) data.||units on a scale||Standard Deviation|Mean
121487|NCT00630825|Secondary|Change From Baseline in Waist Circumference|Mean change from baseline in waist circumference (a measure of central obesity).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable waist circumference data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||centimeters (cm)||Standard Deviation|Mean
121488|NCT00630825|Secondary|Change From Baseline in Body Weight|LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 4, 8, and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||kilograms (kg)||Standard Error|Least Squares Mean
121489|NCT00630825|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.|Baseline and 4 and 8 and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of participants|||Number
121490|NCT00630825|Secondary|Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)|Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable HOMA2-%B or HOMA2-%S data.||percentage of HOMA2||Standard Deviation|Mean
121491|NCT00630825|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood glucose (SMBG) data. For Week 16 data, last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
121492|NCT00630825|Secondary|Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)|Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.|Baseline and 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glucose excursion data.||millimoles per liter (mmol/L)*minute||Standard Deviation|Mean
121493|NCT00630825|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
121494|NCT00630825|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus|Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
121495|NCT00630786|Secondary|Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher|Laboratory values were assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (version 3.0) according to the following: 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-threatening; 5 = Fatal.|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.||participants|||Number
121496|NCT00630786|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment, and includes any such occurrence (eg, sign, symptom, or diagnosis) or worsening of a pre-existing medical condition from the time that a participant has signed informed consent to the time of initiation of investigational product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following:~= Mild: Aware of sign or symptom, but easily tolerated~= Moderate: Discomfort enough to cause interference with usual activity;~= Severe: Incapacitating with inability to work or do usual activity;~= Life-threatening: an event in which the patient was, in the view of the investigator, at risk of death at the time of the event;~= Fatal."|From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks.|Safety Analysis Set, including all randomized patients who received at least one dose of investigational drug.||participants|||Number
121497|NCT00630786|Secondary|Number of Participants With Anti-therapeutic Antibodies|Number of participants with human anti-panitumumab antibodies (HAPA) or anti-conatumumab antibodies measured by immunoassay.|Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks.|Safety analysis set, including all randomized patients who received at least 1 dose of investigational product. N indicates the number of patients with immunoassay results at the specified time points.||participants|||Number
121498|NCT00630786|Secondary|Duation of Response|The interval in days from the first confirmed objective response to disease progression per the modified RECIST criteria or death. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response|||||
125637|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hematological/Lymphatic Nodes’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
121499|NCT00630786|Secondary|Time to Response|The interval in days from the first dose of study therapy to the date of first confirmed objective response. Calculated only for participants with an objective response.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Patients with an overall objective response|||||
121500|NCT00630786|Secondary|Number of Participants With Disease Control|Disease control defined as participants with an overall objective response of complete response (CR), partial response (PR), or stable disease during the treatment period, assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST). Responses were confirmed no less than 4 weeks after the criteria for response were first met. CR defined as the disappearance of all target and non-target lesions and no new lesions. PR defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the nadir LD since the treatment started.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||participants|||Number
121501|NCT00630786|Secondary|Overall Survival|Kaplan-Meier estimate of time from enrollment to death from any cause|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug, who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||months||95% Confidence Interval|Median
121502|NCT00630786|Secondary|Progression-free Survival|Kaplan-Meier estimate of the median time from enrollment to death from any cause or disease progression. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||weeks||95% Confidence Interval|Median
121503|NCT00630786|Primary|Number of Participants With an Objective Response|An overall objective response of either a confirmed complete response or partial response, where the overall objective response was equivalent to the best overall response recorded for each participant from enrollment until disease progression or recurrence. Tumor response was assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Responses were confirmed no less than 4 weeks after the criteria for response were first met. Complete response defined as the disappearance of all target and non-target lesions and no new lesions. Partial response defined as either the disappearance of all target lesions with the persistence of one or more non-target lesion(s), or, at least a 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the Baseline SLD and the disappearance of all or the persistence of 1 or more non-target lesions.|Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks).|Subset of the Safety Analysis Set, composed of all enrolled participants who received at least one dose of study drug who had known Kirsten Rat Sarcoma Virus Oncogene (KRAS) status and Baseline measurable disease.||participants|||Number
121504|NCT00630786|Primary|Part 1: Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) was defined as any grade 3 or 4 conatumumab-related or combination (panitumumab and conatumumab)-related adverse event, or grade 3 or 4 laboratory abnormality that occurred during the first 4 weeks (28 days) of treatment with panitumumab and conatumumab. Anemia and lymphopenia were not considered DLTs.~Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to grade all adverse events and toxicities."|4 weeks|DLT-evaluable patients were those who received ≥ 2 doses of panitumumab and conatumumab as scheduled (ie, weeks 1 and 3) and completed 4 weeks (28 days) of treatment, or had a DLT within the first 4 weeks (28 days) of treatment.||participants|||Number
121505|NCT00630747|Primary|Change From Baseline in Mean Distance Walked in the 6-minute Walk Test (6MWT) at Week 105|Determined on a walking course. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom distance walked was recorded at baseline and at Week 105.||meters (m)||Standard Error|Mean
121506|NCT00630747|Secondary|Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 105|Determined by echocardiogram. LVMI indexed to body surface area (g/m^2). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom cardiac LVM were recorded at baseline and at Week 105.||g/m^2||Standard Error|Mean
121507|NCT00630747|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycans (GAG) Levels at Week 105|Determined by urine testing. The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom normalized urine GAG levels were recorded at baseline and at Week 105.||mcg GAG/mg creatinine||Standard Error|Mean
121508|NCT00630747|Secondary|Change From Baseline in Mean Combined Liver and Spleen Volume at Week 105|Determined by Magnetic Resonance Imaging (MRI). The change was calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom combined liver and spleen volume were recorded at baseline and at Week 105.||cubic centimeters (cc)||Standard Error|Mean
121533|NCT00630487|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)|Participant self-administered questionnaire EQ-5D, a 2 part generic health status instrument. The first part consists of 5 descriptors of current health state: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Scores are assigned on a three-level scale (1= no problem, 2= some problem, 3= extreme problem). The second part was an overall rating of the participant's current health state using a 20 cm Visual Analogue Scale (EQ-VAS) with endpoints labelled ‘best imaginable health state’ and ‘worst imaginable health state’.|Baseline, Week 52, Week 78||||||
121509|NCT00630747|Secondary|Change From Baseline in Mean Passive Joint Range of Motion (JROM) at Week 105|Change was calculated as Week 105 minus baseline. Global JROM (% normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline and at Week 105|All participants for whom passive JROM were recorded at baseline and at Week 105.||percentage of JROM||Standard Error|Mean
121510|NCT00630747|Primary|Change From Baseline in Mean Percent Predicted Forced Vital Capacity (FVC) at Week 105|Determined by spirometry. The change is calculated as Week 105 minus baseline.|Baseline and at Week 105|All participants for whom percent predicted FVC were recorded at baseline and at Week 105.||percent predicted FVC||Standard Error|Mean
121511|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
121512|NCT00630734|Secondary|Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*h/ml||Standard Deviation|Mean
121513|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
121514|NCT00630734|Secondary|Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|Dosing interval of 24 hours|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*h/ml||Standard Deviation|Mean
121515|NCT00630734|Other Pre-specified|Ritonavir Maximum Plasma Concentration (Cmax)|Cmax of ritonavir over a 12-hour dosing interval|0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
121516|NCT00630734|Other Pre-specified|Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of ritonavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*hr/ml||Standard Deviation|Mean
121517|NCT00630734|Other Pre-specified|Darunavir Maximum Plasma Concentration (Cmax)|Cmax of darunavir over a 12-hour dosing interval|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||Standard Deviation|Mean
121518|NCT00630734|Other Pre-specified|Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of darunavir over a 12-hour dosing interval.|0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*h/ml||Standard Deviation|Mean
121519|NCT00630734|Primary|Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)|Cmax of pravastatin when administered with darunavir/ritonavir divided by the Cmax of pravastatin when administered alone.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng/ml||95% Confidence Interval|Mean
121520|NCT00630734|Primary|Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval|AUC of pravastatin when administered with darunavir/ritonavir divided by AUC of pravastatin when administered alone. The AUC was measured over a 24-hour dosing interval.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed the pravastatin alone phase and the pravastatin + darunavir/ritonavir phase of the study.||ng*hr/ml||95% Confidence Interval|Mean
121521|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index||Week 4|ITT||percentage of parabasal cells||Standard Deviation|Mean
121522|NCT00630539|Secondary|Mean Change From Baseline in Sex Hormone Binding Globulin Levels||Week 12|ITT||nmol/L||Standard Deviation|Mean
121523|NCT00630539|Secondary|Mean Change From Baseline in Follicle Stimulating Hormone Levels||Week 12|ITT||U/L||Standard Deviation|Mean
121524|NCT00630539|Secondary|Mean Change From Baseline in Luteinizing Hormone Levels||Week 12|ITT||U/L||Standard Deviation|Mean
121525|NCT00630539|Secondary|Mean Change From Baseline in Estradiol Levels||Week 12|ITT||nmol/L||Standard Deviation|Mean
121526|NCT00630539|Secondary|Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index||Week 4|ITT||percentage of superficial cells||Standard Deviation|Mean
121527|NCT00630539|Secondary|Mean Change From Baseline in Vaginal pH||Week 4|ITT||pH||Standard Deviation|Mean
121528|NCT00630539|Secondary|Visual Evaluation of Vagina (by Gynecological Examination)||Screening & Week 12|ITT||percentage of subjects|||Number
121529|NCT00630539|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT||pH||Standard Deviation|Mean
121530|NCT00630539|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear||12 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
121531|NCT00630539|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear||12 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
121532|NCT00630487|Secondary|Change From Baseline in Cardiovascular Risk Factors|Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)|Baseline, Week 52, Week 78||||||
121534|NCT00630487|Secondary|Change From Baseline in Short Form (36) Health Survey (SF36)|Participant self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT). Scale range 0 to 100, higher scores indicate a better health-related quality of life.|Baseline, Week 52, Week 78||||||
121535|NCT00630487|Secondary|Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)|Participant self administered questionnaire consisting of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life.|Baseline, Week 52, Week 78||||||
121536|NCT00630487|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA)-Index|HOMA index is calculated by 1 of 2 methods: HOMA-Index = fasting insulin measured in microunits per milliliter (µU/ml) times fasting glucose measured in milligrams per deciliter mg/dl) divided by 405 or HOMA-Index = fasting insulin (µU/ml) times fasting glucose measured in millimoles per liter (mmol/l) divided by 22.5.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
121537|NCT00630487|Secondary|Change From Baseline in Safety Laboratory Assessments|Prespecified safety laboratory assessments evaluated for change or no change from baseline. Possible responses were Yes/No.|Baseline, Week 52, Week 78||||||
121538|NCT00630487|Secondary|Change in Executive Function and Memory in Subgroups|Change in executive function and memory in subgroups. Subgroup 1: isolated Growth Hormone Deficiency (GHD)due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). Median reaction time, the total number of errors, the number of omissions and the number of false positive reactions.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
121539|NCT00630487|Secondary|Change From Baseline in Heart Rate|The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
121540|NCT00630487|Secondary|Change From Baseline in Blood Pressure|Blood pressure was measured seated, the subject's arm supported at the level of the heart, and recorded to the nearest mm Hg. The same arm (preferably the dominant arm) was used throughout the trial. The subject was seated for 5 minutes before the blood pressure was obtained. Use of an automated device could have been used for measuring blood pressure.|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
121541|NCT00630487|Secondary|Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])|Alertness: software-based neuropsychological assessment for response time and errors. Memory: analysis of learning and retention using 5-trial presentation of 15-word list (A), single presentation of interference list (B), 2 postinterference recall trials - 1 immediate, 1 delayed - and recognition of the target words with distractors (C). Performance variables were immediate word span under overload conditions, final acquisition level, amount learned in 5 trials, interference, delayed recall, and recognition (implicit learning).|Baseline, Week 52, Week 78|Study terminated, no subjects were treated.|||||
121542|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Waist Circumference)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
121543|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Weight)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
121544|NCT00630487|Secondary|Change From Baseline in Anthropometric Parameters (Height)||Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
121545|NCT00630487|Secondary|Change in Visceral Fat Mass in Subgroups|Change in visceral fat mass in subgroups. Subgroup 1: isolated GHD due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).|Baseline, 52 weeks, 78 weeks|Study terminated, no subjects were treated.|||||
121546|NCT00630487|Primary|Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)|Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.|Baseline, 52 weeks|Study terminated, no subjects were treated.|||||
121547|NCT00630396|Secondary|90 Day Modified Rankin Scale Score|The modified Rankin Scale (mRS) was performed in person at the 90 day clinic follow-up appointment. The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6. 0 represents no symptoms. 1 represents no significant disability. 2 represents slight disability. 3 represents moderate disability. 4 represents moderately severe disability. 5 represents severe disability. 6 represents death.|3 months|||Participants|||Number
121548|NCT00630396|Secondary|Half-life of IV Minocycline|In eligible patients enrolled at Georgia Health Sciences University, blood samples were drawn for quantification of minocycline serum concentrations. This enabled the study team to determine the half life of the study drug.|For each subject blood samples were drawn before dose #1 and one hour after starting dose #1. Additional blood was drawn 1, 6, 12, 24, 48, and 72 hours after starting dose #6, which lasted approximately 6 days.|||hours|Participants|Standard Error|Mean
121549|NCT00630396|Primary|Maximally Tolerated Dose of IV Minocycline|Investigators closely monitored each subject for evidence of minocycline intolerance. All adverse events were immediately reported for a decision whether to discontinue the study medication and/or reduce the dose. A computer program was used to determine the maximum tolerated dose. After entering information regarding doses and expected toxicities, results for each subject as they were collected were entered. The computer program informed as to (de)escalation, or maintenance of the same dose in the subsequent cohort of enrolled patients.|3 days|||mg/kg|||Number
121550|NCT00630344|Secondary|To Characterize the Toxicity Profile of RAD001 in Combination With Standard Dose Bicalutamide in Patients With Androgen Independent Prostate Cancer.||3 years||||||
121566|NCT00630058|Primary|T1/2(Time of Half-Life) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||hours||Standard Deviation|Mean
121551|NCT00630344|Primary|To Determine the Best Overall Response and Duration of Response, Taking Into Consideration Measurable Disease, Bone Metastases and PSA.|The primary endpoint of this Phase II study is the best overall response, taking into consideration measurable disease, bone metastases, and PSA. A patient will be considered to have a favorable outcome if PSA declines in the absence of measurable disease without the appearance of new bone lesions, or if a response in measurable disease consistent with RECIST guidelines is observed, without an increase in PSA or the appearance of new bone lesions. Patients with stable disease lasting at least 6 months will also be considered to have favorable outcome.|3 years|||participants||95% Confidence Interval|Number
121552|NCT00630331|Secondary|Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.|Up to 7 days post vaccination|Analysis was done on Safety population i.e. all subjects in the exposed population who provide post vaccination safety data.||Subjects|||Number
121553|NCT00630331|Secondary|Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.|Three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.||Percentages of subjects||95% Confidence Interval|Number
121554|NCT00630331|Secondary|Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo|Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on a subset of subjects who constituted the PP immunogenicity population.||Percentages of subjects||95% Confidence Interval|Number
121555|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
121556|NCT00630331|Secondary|Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on PP efficacy population.||Numebr of Days of Usual Activity Lost||Standard Deviation|Mean
121557|NCT00630331|Secondary|Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done of PP efficacy population.||Number of Medical Visits||Standard Deviation|Mean
121558|NCT00630331|Secondary|Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done of PP efficacy population.||Number of Medical Visits||Standard Deviation|Mean
121559|NCT00630331|Secondary|Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza|The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.|6 Months|Analysis was done on PP efficacy population.||Number of Days||Standard Deviation|Mean
121560|NCT00630331|Secondary|Influenza-Associated Days in Bed, All Subjects|The number of subjects in this analysis included all subjects in the per protocol efficacy population.|6 Months|Analysis was done on the PP efficacy population.||Number of Days||Standard Deviation|Mean
121561|NCT00630331|Secondary|Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.||Subjects|||Number
121562|NCT00630331|Secondary|Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.|6 Months|Analysis was done on PP efficacy population.||Subjects|||Number
121563|NCT00630331|Primary|Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains|The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.|6 Months|Analysis was performed on per protocol (PP) efficacy population i.e. the subjects in the exposed efficacy population who correctly received the vaccine and provided evaluable swab samples at the relevant time points.||Subjects|||Number
121564|NCT00630292|Primary|Amount of Blood Vessel Tortuosity in Breast With Known Cancer|Amount of vessel tortuosity before the start of neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy|up to two weeks prior to start of chemotheraphy|Blood vessels could not be detected for any of the subjects due to spatial resolution limits of MRI scanner for breast MRI and therefore measurement of blood vessel angularity could not be performed.||sum of blood vessel angles|||Number
121565|NCT00630058|Secondary|Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels|HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2–7.8 log10 IU/mL.|37 weeks|||Log IU / mL||Standard Deviation|Mean
121598|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Score on a scale||Full Range|Mean
121568|NCT00630058|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
121569|NCT00630058|Primary|Tmax (Time of Maximum Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||hours||Full Range|Median
121570|NCT00630058|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|"Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.~Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57."|Data were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
121571|NCT00629850|Primary|Change in Negative Inspiratory Force Using a Pressure Manometer||10 weeks|there was only one participant completing this study. No analyses performed.||cmH2O|||Number
121572|NCT00629850|Primary|Change in Maximum Voluntary Ventilation Using Pulmonary Function Device|pulmonary function device measures flow rate in liters per minute|10 weeks|there was only one participant completing this study. No analyses performed.||liter per minute|||Number
121573|NCT00629850|Primary|Number of Participants With Improvement in Sleep Quality.|Improvement in sleep quality as defined by: less fragmented sleep, lower apnea hypopnea index (AHI), respiratory disturbance index (RDI) after device use.|10 weeks|There was only one participant completing the study. No analyses performed.||participants|||Number
121574|NCT00629772|Secondary|Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26|Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles.|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
121575|NCT00629772|Secondary|Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.~0 = clear~1 = almost clear~2 = Mild~3 = Moderate~4 = Severe~5 = Very severe"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
121576|NCT00629772|Secondary|Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26.~Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.~0-1 = no effect at all on patient's life~2-5 = small effect on patient's life~6-10 = moderate effect on patient's life~11-20 = very large effect on patient's life~21-30 = extremely large effect on patient's life"|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
121577|NCT00629772|Secondary|Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26|"Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26.~m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|Baseline, 26 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percent improvement||Standard Deviation|Mean
121578|NCT00629772|Secondary|Mean Physician's Global Assessment (PGA) at Week 14|"Efficacy by comparing the mean Physician's Global Assessment(PGA).~0 = clear.~1 = almost clear.~2 = Mild.~3 = Moderate.~4 = Severe.~5 = Very severe."|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
121579|NCT00629772|Secondary|Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14|Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected).|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Percentage of affected area||Standard Deviation|Mean
121580|NCT00629772|Secondary|Mean Dermatology Life Quality Index (DLQI) at Week 14|"Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.~0-1 = no effect at all on patient's life~2-5 = small effect on patient's life~6-10 = moderate effect on patient's life~11-20 = very large effect on patient's life~21-30 = extremely large effect on patient's life"|14 weeks|The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
121581|NCT00629772|Secondary|Number of Adverse Events at Week 14|Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events|14 weeks|||Adverse Events|||Number
121599|NCT00629239|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).|Daily during run-in and treatment|||Scores on a scale||Full Range|Mean
121582|NCT00629772|Primary|75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0|"Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|14 weeks|The analysis was performed on the intent to treat (ITT) population. Nonresponder imputation (NRI) was used for patients who withdrew before the end of the study. They were treated as nonresponders from the point of withdrawal onward.||Participants|||Number
121583|NCT00629707|Secondary|Brain NAA/Creatine Ratio & Brain Lactate Measured by MR Spectroscopy, Cerebral Blood Flow & Oxygen Saturation Measured by MR Perfusion Weighted Imaging & Near Infrared Spectroscopy, Mental Status Evaluated by Glasgow Coma Scale Scores.||twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment||||||
121584|NCT00629707|Primary|Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)|In both groups, brain Apparent Diffusion Coefficient (ADC) measures at 3-6 hours and 9-12 hours after beginning DKA treatment were averaged to determine overall brain ADC during DKA treatment. The brain ADC indicates the distribution of water in the brain and is an indicator of brain swelling (edema). The overall brain ADC values during DKA treatment were compared with the brain ADC measured after recovery to assess the degree of brain edema formation during DKA treatment. The difference in brain ADC, calculated as the averaged treatment values minus the recovery value, was used as the main outcome measure to indicate the degree of brain edema formation|twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment|Data from all enrolled participant that completed the study were analyzed.||mm^2/sec||Standard Deviation|Mean
121585|NCT00629525|Secondary|Clinical Response|"The percentage of participants with a complete or partial response as defined by RECIST 1.0. Response Criteria are defined below:~Complete Response: Disappearance of all target lesions Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD"|Patients were followed for a median of 315 days|||participants|||Number
121586|NCT00629525|Secondary|Molecular Response|Functional extent of mTOR inhibition by changes in the phosphorylation status of pS6 in prostate tumors.|Patients were followed for a median of 315 days|Immunohistochemistry (IHC) for pS6 was compared for 9 pairs of samples for which paraffin embedded tissue was available.||percentage of decrease||Full Range|Mean
121587|NCT00629525|Secondary|Progression Free Survival|Time in months from the start of study treatment to the date of first progression according to RECIST 1.0, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 315 days, with the last patient censored at 1309 days.|Intent to treat||months||95% Confidence Interval|Median
121588|NCT00629525|Secondary|Pathologic Response|Number of participants with either a 50% or greater decrease in proliferation index or a 50% or greater increase in apoptotic index|Patients were followed for a median of 315 days|Only subjects with paired samples were included in this analysis||participants|||Number
121589|NCT00629525|Primary|Biochemical Response Rate|Number of participants with 50% decline in serum PSA from baseline was pre-set as the primary measure of disease response.|Patients were followed for a median of 315 days|||participants|||Number
121590|NCT00629499|Secondary|Overall Survival||18 Months||||||
121591|NCT00629499|Secondary|Disease-free Survival||18 Months||||||
121592|NCT00629499|Primary|Tolerability of Adjuvant Nab Paclitaxel Using Weekly Dosing Schedule Assessed by Patient Survival, Disease Recurrence, and Treatment-related Toxicity.||18 Months|Patients were analyzed if they remained alive and without evidence of recurrence.||participants|||Number
121593|NCT00629265|Secondary|Performance Status Scale for Head and Neck Cancer Patients (PSS); The Head and Neck Cancer Inventory (HNCI)|"Perceive improved in quality of life and eating ability as measured by 2 validated scales: the Performance Status Scale for Head and Neck Cancer Patients (PSS) and The Head and Neck Cancer Inventory (HNCI).~The PSS (List, et. al., 1990) is a clinician adminsitered scale that has three domains (normalcy of diet, eating in public, and understandability of speech). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best.~The HNCI (Funk, et. al., 2003) is patient administered questionnaire that has four domains (social disruption, aesthetics, speech, eating). Each domain as well as overall score is scored on a scale of 0-100, with 0=worst and 100=best."|Before and after treatment|Note: the number of participants analyzed (126) does not match the total number enrolled (170) because 44 people did not have adequate follow up data required for this secondary analysis.||Change in PSS and HNCI score||Standard Deviation|Mean
121594|NCT00629265|Primary|Change in Penetration-Aspiration Scale (PAS) Score|"The PAS scale is a validated 8-point ordinal scale (Rosenbek et. al 1996) in which a score of 1 is best (material does not enter the airway) and a score of 8 is worst (material enters the airway, passes below the vocal folds, and no effort is made to eject it).~Difference in mean PAS scores after 12 weeks of therapy was analyzed between the two groups of interest: Active NMES + Swallowing Exercise versus Sham (inactive) NMES + Swallowing Exercise. PAS scores were obtained from fluoroscopy (modified barium swallow) studies adminstered at three time points - enrollment, midway through treatment (6 weeks), and at end of treatment (12 weeks). All fluoroscopy studies were sent to, and analyzed by, a blinded external central laboratory."|Before and after treatment|Note: the number of participants analyzed (125) does not match the total number enrolled (170) because 45 people did not have adequate follow up data required for this primary analysis.||Change in points on PAS||Standard Deviation|Mean
121595|NCT00629239|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 4 weeks of treatment|||meter||Full Range|Mean
122810|NCT00618410|Secondary|Eosinophil Influx [Pre-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|before antigen challenge|||percentage of white blood cells||Full Range|Median
121600|NCT00629239|Secondary|The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||Score on a scale||Full Range|Mean
121601|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
121602|NCT00629239|Secondary|Peak Expiratory Flow (PEF) Morning|Change from average during run-in to average during treatment|Daily during run-in and treatment|||L/min||Full Range|Mean
121603|NCT00629239|Secondary|Forced Expiratory Flow (FEF) 25%-75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L/s||Full Range|Mean
121604|NCT00629239|Secondary|Inspiratory Capacity (IC)|Change from IC baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
121605|NCT00629239|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
121606|NCT00629239|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
121607|NCT00629239|Secondary|Forced Expiratory Volume 1 (FEV1)|Change in (FEV1) from baseline to end of treatment|Before treatment and after 1, 2, 3 and 4 weeks of treatment|||L||Full Range|Mean
121608|NCT00629239|Primary|Number of Patients Experiencing Adverse Events|Number of patients who had an Adverse Event|At all study visits|||Participants|||Number
121609|NCT00629018|Secondary|Changes in Left Ventricular Function||5 years||||||
121610|NCT00629018|Secondary|Changes in Plasma Inflammatory Markers||6 months||||||
121611|NCT00629018|Secondary|Changes in Electrophysiologic Properties of Ventricular Myocardium||6 months||||||
121612|NCT00629018|Secondary|Changes in Exercise Capacity||5 years||||||
121613|NCT00629018|Primary|Changes in Left Ventricular Ejection Fraction|Left ventricular ejection fraction measured by echocardiography|5 years|||Percentage of ejection||Standard Deviation|Mean
121614|NCT00629018|Primary|Heart Failure Mortality||5 years|The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.||participants|||Number
121615|NCT00628927|Secondary|Tail Length From the Comet Assay for Oxidative Damage|The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage.|Single study visit|||µm||Standard Deviation|Mean
121616|NCT00628927|Secondary|Barrett Impulsiveness Scale Version 11 (BIS-11)|"The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from Rarely/Never to Almost Always/Always and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90)."|Single study visit|||units on a scale||Standard Deviation|Mean
121617|NCT00628927|Primary|Stroop Color-word Task|The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ‘‘red’’ might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.|Single study visit|||seconds||Standard Deviation|Mean
121618|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|12 months|||Scores on a scale||Standard Deviation|Mean
121619|NCT00628901|Secondary|Health Related Quality of Life Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|3 months|||Scores||Standard Deviation|Mean
121620|NCT00628901|Secondary|Health Related Quality of Life (HRQL)Subscores|"The HRQL subscales (concern, activities, energy/mood, control, self-conscious, and sexual function were collected from the UFS-QoL.~Each individual subscale is added. HRQL Total (sum of 6 subscales); lowest possible raw score = 29, highest possible raw score=145. A formula is used to transform the HRQL raw scores (Highest possible score-actual raw score divided by possible raw score range x 100). Higher scores are indicative of a better HRQL and lower scores indicate a worse HRQL (High=good). The value reported for this measure is the average of all participants scores."|Baseline|||Scores on a scale||Standard Deviation|Mean
121621|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100.The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)."|12 months|||Scores on a scale||Standard Deviation|Mean
125638|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Psychiatric’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
121622|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|3-months|||Scores on a scale||Standard Deviation|Mean
121623|NCT00628901|Secondary|Uterine Fibroid Symptom Quality of Life Questionaire (UFS-QOL) Score|"The UFS-QoL asks the subjects feelings and experiences regarding the impact of uterine fibroid symptoms and experiences during the previous 3 months.~The scores are added and the final total scores range from 0-100. The lowest actual raw score=8, the highest raw score=40, the possible raw score range=32. A formula is then used to transform the value(actual raw score-lowest possible raw score divided by possible raw score range x100). Higher symptom score values are indicative of greater symptom severity or bother and lower scores indicate minimal symptom severity (high scores = bad)"|Baseline|||Scores on a scale||Standard Deviation|Mean
121624|NCT00628901|Secondary|Any Adverse Events That the Participant Experienced|Summary of investigator reported adverse events and adverse device effects, including all serious adverse events and unanticipated adverse device effects. Adverse events were collected systematically, meaning they were collected during the participant's follow-up visit, during telephone contacts, or during medical record review.|During the hospitalization stay post UFE|||events|||Number
121625|NCT00628901|Secondary|Procedure Time|Procedure time is the time in minutes of the first arterial puncture to time of hemostasis (stopping bleeding)|During the study procedure (measured in minutes)|||minutes||Standard Deviation|Mean
121626|NCT00628901|Secondary|Fluoroscopy Time|Fluoroscopy is the method that provides real-time X ray imaging used for guiding a variety of diagnostic and interventional procedures. Fluoroscopy time is described as the amount of time the patient underwent fluoroscopy.|During the study procedure (measured in minutes)|||minutes||Standard Deviation|Mean
121627|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Pain|Maximum level of pain was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no pain' and the right side (10cm) of the line represents 'worst imaginable'. The patient is asked to place a mark on the line that represents their level of pain. For example, a reading of 10cm = worst imaginable pain.|24 hours after study procedure|||cm||Standard Deviation|Mean
121628|NCT00628901|Secondary|Visual Analog Scale (VAS) Maximum Level of Nausea|Maximum level of nausea was measured using the Visual Analog Scale(VAS). The patient is presented with a picture of a straight line that is 0-10 cm long. The left side of the line (0 cm) represents 'no nausea' and the right side (10cm) of the line represents 'worst nausea imaginable'. The patient is asked to place a mark on the line that represents their level of nausea. For example, a reading of 10cm = worst nausea imaginable.|24 hours after study procedure|||cm||Standard Deviation|Mean
121629|NCT00628901|Primary|Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)|MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).|24-hours post study procedure|||participants|||Number
121630|NCT00628862|Secondary|St George’s Respiratory Questionnaire (SGRQ)|Patients were asked to complete the St George’s Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement.|12 weeks (end of run-in to last visit)|||Scores on a scale||Standard Deviation|Mean
121631|NCT00628862|Secondary|Use of Reliever Medication|Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|12 weeks (end of run-in to last visit)|||medication doses per day||Standard Deviation|Mean
121632|NCT00628862|Secondary|Cough|Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks|||scores on a scale per day||Standard Deviation|Mean
121633|NCT00628862|Secondary|Breathlessness|Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks|||scores on a scale per day||Standard Deviation|Mean
121634|NCT00628862|Secondary|Change in Night-time Awakenings Due to Symptoms|Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period up to 12 weeks|||scores on a scale per day||Standard Deviation|Mean
121635|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Evening|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week|||L/min||Standard Deviation|Mean
121636|NCT00628862|Secondary|Change in Peak Expiratory Flow (PEF), Morning|Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value|run-in period and 12 week|||L/min||Standard Deviation|Mean
121637|NCT00628862|Secondary|FVC 5 Minutes Post-dose|Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose|||percent of baseline||Full Range|Geometric Mean
121638|NCT00628862|Secondary|FEV1 5 Minutes Post-dose|Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value|baseline and 5 minutes anter first dose|||percent of baseline||Full Range|Geometric Mean
121639|NCT00628862|Secondary|FVC Pre-dose|Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12|||percent of baseline||Full Range|Geometric Mean
121640|NCT00628862|Secondary|FEV1 Pre-dose|Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value|baseline at week 0 and pre-dose at weeks 4, 8 and 12|||percent of baseline||Full Range|Geometric Mean
121641|NCT00628862|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value|from baseline up to 12 weeks|||percent of baseline||Full Range|Geometric Mean
121642|NCT00628862|Primary|Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose|FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.|from baseline up to 12 weeks|||percent of baseline||Full Range|Geometric Mean
121643|NCT00628758|Secondary|Mean Use of As-needed Medication Per Day During Treatment Period|Mean use of as-needed medication per day during treatment period|Daily recording during the treatment period of 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient’s estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits.||inhalations per day||Standard Deviation|Mean
121644|NCT00628758|Secondary|Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score|Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.|Baseline and 26 weeks|ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.||Units on a scale||Standard Deviation|Mean
121645|NCT00628758|Secondary|Number of Severe Asthma Exacerbations|Total number of severe asthma exacerbations per treatment group|26 weeks|||Severe Exacerbations|||Number
121646|NCT00628758|Primary|Time to First Severe Asthma Exacerbation|Time to severe exacerbation among patients|26 weeks|||days||Standard Deviation|Mean
121647|NCT00628628|Primary|Number of Participants With Plasma Uric Acid (UA) Response|Plasma UA response is defined as normalization of plasma UA levels within 48 hours after the start of study drug (rasburicase) and maintaining within the normal range after the final drug infusion on day 5. Plasma samples for UA were collected at baseline before rasburicase, 4- and 24-hours post-rasburicase, and daily during treatment.|First cycle of chemotherapy, up to 5 days|||participants|||Number
121648|NCT00628446|Secondary|Adherence to NCEP Criteria|Determine the total percentage of subjects who should be on drug therapy by NCEP criteria and who are on drug therapy who have achieved their treatment goal as defined by NCEP criteria|During single data collection|38 subjects completed the data collection||percentage of participants|||Number
121649|NCT00628446|Primary|Percent Agreement Between Coronary Calcium Score (CCS) and National Cholesterol Education Program (NCEP) Guidelines|Participants were classified as high risk, intermediate high risk, intermediate low risk, and low risk based upon both their CCS and their LDL using NCEP Adult Treatment Panel III Guidelines. Those with CCS >/-400 were considered high risk, CCS=100-399 were intermediate high risk, CCS=1-99 intermediate low risk, and CCS=0 were low risk. The percent agreement between CCS and NCEP Guidelines was calculated by totaling the number of subjects who were classified in the same risk category and dividing by the total number of subjects|During single data collection. Average duration of injury was 24.4 years +/-9.5 years|||percent agreement|||Number
121650|NCT00628407|Primary|Sternal Force Associated With Change in Intrathoracic Pressure.|The mean sternal force (measured in kg as a surrogate for Newtons [1kg = 9.81 newtons]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.|per case|||kg||Standard Deviation|Mean
121651|NCT00628355|Primary|Clinical Response Rate|We analyzed the clinical response rate considering significative reduction of 50% of visual analogue scale or significative subjective improvement.|immediately, 1, 3 months after treatment|||percentage of participants|||Number
121652|NCT00628355|Primary|Intensity of Pain|"The pain will measured by using the visual analogue scale, that is represented by a straight line of 100mm starting at absence of pain and ending at point worst pain experienced or imagined."|immediately, 1, 3 months after treatment|||millimeters||Standard Deviation|Mean
121653|NCT00628251|Secondary|Best QoL Response for FACT-O Symptom Index (FOSI)|Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FOSI at baseline||Number of patients|||Number
121654|NCT00628251|Secondary|Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for FACT-O at baseline||Number of patients|||Number
121655|NCT00628251|Secondary|Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)|Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Evaluable for TOI at baseline||Number of patients|||Number
121697|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121656|NCT00628251|Secondary|Overall Survival (OS)|OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals|At the time of the cut-off for the final analysis of overall survival (30 April 2010)|||Number of deaths|||Number
121657|NCT00628251|Secondary|Disease Control Rate|The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Participants|||Number
121658|NCT00628251|Secondary|Confirmed RECIST Response and/or CA-125 Response|The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Percentage of participants|||Number
121659|NCT00628251|Secondary|Best Percentage Change From Baseline in CA-125 Levels|Best percentage change in cancer antigen 125 (CA-125) levels|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Percent change||Full Range|Median
121660|NCT00628251|Secondary|Best Percentage Change in Tumour Size|The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Percent change||Full Range|Median
121661|NCT00628251|Secondary|Duration of Response|The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|Duration of response is analysed for patients experiencing a response.||Months||95% Confidence Interval|Median
121662|NCT00628251|Secondary|Objective Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumours - RECIST)|ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.|At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)|||Number of responders|||Number
121663|NCT00628251|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)|Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)|||Number of patients that progressed|||Number
121664|NCT00628212|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg*h / dL||Standard Error|Least Squares Mean
121665|NCT00628212|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.||mg / dL||Standard Error|Least Squares Mean
121666|NCT00628212|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||mg / dL||Standard Error|Least Squares Mean
121667|NCT00628212|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.||Percent||Standard Error|Least Squares Mean
121668|NCT00628134|Secondary|Peripheral Lung Dose|Change over 30 minutes in the percentage of the total deposited aerosol dose found in the peripheral lung zone. We are reporting the %peripheral dose at t=30 minus the %peripheral dose at t=0. This dose is determined based on measured radioactive counts after aerosol delivery, using nuclear medicine gamma camera images. The central lung zone is defined as a rectangle with 1/2 the height and 1/2 the width of a rectangle that surrounds the right whole lung. The peripheral zone is the portion of the lung image not included in the central lung zone.|30 minutes after delivery|||percentage of lung dose||Standard Deviation|Mean
121698|NCT00627926|Secondary|Number of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.|Week 4 and Week 12|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121669|NCT00628134|Primary|Uniformity of Aerosol Distribution|Measured change in central/peripheral (c/p) dose ratio over a 30 minute period after aersol delivery (c/p at t=30 - c/p at t=0). Central and peripheral lung doses are measured as radioactive counts depicted on nuclear medicine gamma camera images after radioisotope aerosol delivery. The central lung zone is a rectangle with 1/2 the height and 1/2 the width of a box outlining the whole right lung. The peripheral lung zone is defined as the portion of the lung outside of the central lung zone. A change in c/p ratio over time would indicate transport of material from one lung zone to the other. The variable represents the realtive proportion of airways dosing to alveolar dosing - an indication of deposition uniformity in the lungs.|30 minutes|||ratio||Standard Deviation|Mean
121670|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [μmol/L]||Full Range|Median
121671|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed||millimole per liter [mmol/L]||Full Range|Median
121672|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
121673|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
121674|NCT00628108|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [µmol/L]||Full Range|Median
121675|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
121676|NCT00628108|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|7 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
121677|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
121678|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
121679|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
121680|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
121681|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG)|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
121682|NCT00628108|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||beats per minute||Standard Deviation|Mean
121683|NCT00628030|Secondary|Parental Dietary Intake of Fat|Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.|Baseline, Posttest|||grams||Standard Deviation|Mean
121684|NCT00628030|Secondary|Parental BMI|Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.|Baseline, Posttest|||kg/m^2||Standard Deviation|Mean
121685|NCT00628030|Secondary|Child Quality of Life|"Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest~We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life.~We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales.~The current report did not provide subscores."|Basline, Posttest|||units on a scale||Standard Deviation|Mean
121686|NCT00628030|Secondary|Child Feeding|"The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale concern about child's weight is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test)."|Basline, Posttest|||units on a scale||Standard Deviation|Mean
121687|NCT00628030|Primary|Child BMI|Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.|Basline, Posttest|||percentile||Standard Deviation|Mean
121699|NCT00627926|Secondary|Number of Subjects Achieving Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121688|NCT00627926|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121689|NCT00627926|Primary|Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.|24 weeks after last planned dose of study treatment (up to Week 72)|The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121690|NCT00627926|Secondary|Fatigue Severity Scale (FSS) Total Score|FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.|Baseline, Week 4, 12, 24, 36, 48, 72|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here n signifies those participants who were evaluable for this measure at given time points for each group, respectively."||units on a scale||Standard Deviation|Mean
121691|NCT00627926|Secondary|Noninvasive Markers of Fibrosis: Number of Subjects With Improvement in FibroTest Analysis|FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.|Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)|"The FA set included all randomized subjects who received at least 1 dose of any study drug. Here number of participants analyzed signifies those subjects who were evaluable for FibroTest Analysis and n signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively."||participants|||Number
121692|NCT00627926|Secondary|Biochemical Response: Number of Subjects With Grade 3 and 4 Shifts From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels|Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (<1.25*upper limit of normal [ULN]); Grade 1 (mild=1.25 to 2.5*ULN); Grade 2 (moderate=2.6 to 5.0*ULN); Grade 3 (severe= greater than 5.0 to 20.0*ULN); Grade 4 (life-threatening= greater than 20.0*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.|Baseline up to Week 48|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121693|NCT00627926|Secondary|Number of Subjects With Viral Relapse Planned and Viral Relapse Actual|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
121694|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|24 weeks after last actual dose of study treatment (up to Week 72)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121695|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|12 weeks after last planned dose of study treatment (up to Week 60)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121696|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|End of treatment (up to Week 48)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
126228|NCT00587158|Secondary|Mean Change in Estimated Glomerular Filtration Rate (eGFR) Between 3 Weeks and 1 Year Post Transplant||3 weeks, 1 year post kidney transplant|Per-protocol analysis||mL/min/1.73 m^2||Standard Deviation|Mean
121700|NCT00627926|Secondary|Number of Subjects With Undetectable HCV RNA at Week 72|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.|Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)|The FA set included all randomized subjects who received at least 1 dose of any study drug.||participants|||Number
121701|NCT00627861|Secondary|Blood Pressure||all visits (weekly for 12 weeks)|||mm Hg|||Number
121702|NCT00627861|Secondary|Plasma Renin Activity|The blood test, plasma renin activity or PRA, is being measured during the visits outlined.|screening, 4th, 6th, 7th, 9th, 10th, 11th, 12th weeks|||ng/mL/h|||Number
121703|NCT00627861|Primary|Plasma Renin Concentration||5th, 6th, 7th, 9th, 10th, 11th, 12th weeks|||pg/mL|||Number
121704|NCT00627679|Primary|Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).|8 hours|||min||Standard Deviation|Mean
121705|NCT00627679|Primary|AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.||pg*min/mL||Standard Deviation|Mean
121706|NCT00627679|Primary|AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010|The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.||pg*min/mL||Standard Deviation|Mean
121707|NCT00627679|Primary|Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010|Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).|8 hours|Patients with available data at specified time points are included in the analysis population.||min||Standard Deviation|Mean
121708|NCT00627679|Primary|Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|8 hours|Patients with available data at specified time points are included in the analysis population.||pg/mL||Standard Deviation|Mean
121709|NCT00627523|Secondary|Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.|Body mass index was calculated for all visits by means of the following formula: BMI (kg/m2) = Weight (kg)/(Height[m])2. The change from Baseline BMI was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Kg/m2||Standard Deviation|Mean
121710|NCT00627523|Secondary|Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24.|Body weight was measured at all the relevant visits. The change from Baseline in body weight was calculated as the difference between the parameter values at each visit, and the Baseline parameter values.|Baseline, Months 3, 6, 12, 18, and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Kg||Standard Deviation|Mean
121711|NCT00627523|Secondary|Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)–(Normal head circumference)/Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Baseline, Months 3, 6, 12, 18 and 24.|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||SDS||Standard Deviation|Mean
121712|NCT00627523|Secondary|Head Circumference SDS at Months 3, 6, 12, 18 and 24.|Head circumference SDS was calculated by means of the following formula = (Participant head circumference)–(Normal head circumference)/ Normal head circumference standard deviation. Where participant head circumference refers to the participant's head circumference at the relevant visit, and normal head circumference and the normal head circumference standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. A negative score indicated a participant had a smaller head circumference for their age/gender.|Months 3, 6, 12, 18 and 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||SDS||Standard Deviation|Mean
121722|NCT00627497|Secondary|Success Rate of SF-36 Health Survey|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 PCS and MCS for DIAM Device vs. Single-Level Posterior Decompression were defined as: (Post Score - Pre Score) / Pre Score>= 20%. The success rates of SF-36 PCS and MCS for DIAM vs. Posterolateral Interbody Fusion were defined as: Post Score - Pre Score >= 0.|24 month after operation|||percentage of participants|||Number
121723|NCT00627497|Secondary|General Health Status (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|24 month after operation|||Scores on a scale||Standard Deviation|Mean
121713|NCT00627523|Secondary|Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.|BSID-II measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the psychomotor raw score which was used to calculate the PDI score. Possible PDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Units on a scale||Standard Error|Least Squares Mean
121714|NCT00627523|Secondary|Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.|The Bayley Scale of Infant Development (BSID-II) measured the mental and psychomotor development and test behavior of participants from 1 to 42 months of age. The scale was used to describe the current developmental functioning of infants and to assist in diagnosis and treatment planning for infants with developmental delays or disabilities. The BSID-II provided the mental raw score which was used to calculate the MDI score. Possible MDI scores ranged from 50-150. A score of 69 and below indicates significantly delayed performance, 70 to 84 indicates mildly delayed performance, 85 to 114 indicates normal limits and 115 and above indicates accelerated performance.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control group for safety analysis.||Units on a scale||Standard Error|Least Squares Mean
121715|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 12.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) – (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant’s growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
121716|NCT00627523|Secondary|Change From Baseline in Height SDS at Month 12.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant’s height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 12|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
121717|NCT00627523|Secondary|Change From Baseline in Growth Velocity SDS at Month 24.|The growth velocity SDS was calculated at the relevant visit by means of the following formula: Growth velocity SDS = (participant growth velocity) – (normal growth velocity)/normal growth velocity standard deviation. Where, participant growth velocity refers to the participant’s growth velocity at the relevant visit, and normal growth velocity and the normal growth velocity standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for growth velocity SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. A negative score indicated that a participant had slower growth for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
121718|NCT00627523|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.|Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant’s height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.|Baseline and Month 24|Full Analysis Set (FAS) included participants who were randomized to treatment and completed at least one post-baseline efficacy measure. Missing values were imputed using LOCF method. One participant was randomized to Genotropin® but did not receive any treatment. This participant was excluded from FAS but included in Control for safety analysis.||SDS||Standard Error|Least Squares Mean
121719|NCT00627497|Secondary|Hospital Stay||At the time of discharge|||days||Standard Deviation|Mean
121720|NCT00627497|Secondary|Blood Loss||At the time of operation|||ml||Standard Deviation|Mean
121721|NCT00627497|Secondary|Operative Time||at the time of operation|||hrs||Standard Deviation|Mean
126950|NCT00578812|Secondary|Dysphagia for Swallowing|Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol||mm||Standard Deviation|Mean
121725|NCT00627497|Secondary|Leg Pain|Numerical rating scales are used to evaluate leg intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” A patient’s total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).|24 month after operation|||units on a scale||Standard Deviation|Mean
121726|NCT00627497|Secondary|Back Pain Success Rate|Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.|24 month after operation|||percentage of participants|||Number
121727|NCT00627497|Secondary|Back Pain|Numerical rating scales are used to evaluate back pain intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” A patient’s total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).|24 month after operation|||units on a scale||Standard Deviation|Mean
121728|NCT00627497|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 month after operation|||percentage of particpants|||Number
121729|NCT00627497|Secondary|Success Rate of Oswestry Diability Index Scores|Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score – Post-treatment Score ≥ 15.|24 month after operation|||percentage of participants|||Number
121730|NCT00627497|Secondary|Oswestry Disability Index (ODI) Score|The self-administered Oswestry Disability Index (ODI) Questionnaire was used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 month after operation|||Scores on a scale||Standard Deviation|Mean
121731|NCT00627497|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of partipants who met all of the following criteria:~Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score – Post-treatment Score ≥ 15);~Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated);~No serious adverse event classified as “surgical treatment associated”;~No additional surgical procedure classified as “failure.”"|24 months after operation|||percentage of patients|||Number
121732|NCT00627445|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
121733|NCT00627445|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||episodes|||Number
121734|NCT00627445|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||kg||Standard Error|Least Squares Mean
121735|NCT00627445|Secondary|The Total Increase in Total Daily Insulin Dose Per Body Weight|The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).|week 0, week 16|Intention-to-Treat analysis set (ITT) is all randomised subjects exposed to at least one dose of trial product.||U/kg||Standard Error|Least Squares Mean
121736|NCT00627445|Secondary|Change and Daily Average in Prandial Plasma Glucose Increment|Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
121737|NCT00627445|Secondary|Change and Daily Average in 8-point Plasma Glucose|Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||mmol/L||Standard Error|Least Squares Mean
121738|NCT00627445|Secondary|The Percentage of Subjects Achieving HbA1c Treatment Targets|The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.|week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||percentage (%) of subjects|||Number
121739|NCT00627445|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)|week 0, week 16|Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
121744|NCT00627393|Secondary|Donor Availability (Proportion of Scheduled Granulocyte Transfusion Days on Which Granulocytes Were Available)||Measured through study completion|The unit of analysis is patient-days where a granulocyte transfusion was scheduled.||percentage of available granulocyte days|Participants||Number
121745|NCT00627393|Secondary|Serious Adverse Events in Granulocyte Donors||Measured at Week 1 after G-CSF administration|237 subjects consented to G-CSF and dexamethasone administration prior to granulocyte donation.||participants|||Number
121746|NCT00627393|Secondary|Long-term Survival||Measured at Month 3|All randomized subjects.||participants|||Number
121747|NCT00627393|Secondary|Time to Negative Blood Culture for Participants With Positive Blood Culture at Baseline||Measured through Day 42||||||
121748|NCT00627393|Secondary|Time to Negative Test for Fungal Antigenemia (e.g., Galactomannan Antigenemia Among Participants With Invasive Aspergillosis)||Measured at Days 7, 14, and 42||||||
121749|NCT00627393|Secondary|Fever Resolution|Fever resolution between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured through Day 42|Subjects who had fever at baseline.||proportion of subjects, resolved fever|||Number
121750|NCT00627393|Secondary|Overall Incidence of Adverse Effects||Measured through Day 42|All randomized subjects.||participants|||Number
121751|NCT00627393|Secondary|Graft Versus Host Disease Among Recipients of Allogeneic Stem Cell Transplantation|Time to GVHD incidence between the two treatment groups was compared using Gray's model that takes into account death as a competing risk.|Measured at Day 42|Subjects who had allogeneic stem cell transplantation||proportion of subjects, GVHD incidnence|||Number
121752|NCT00627393|Secondary|Serious Granulocyte Transfusion Reactions, Including Febrile, Allergic, and Pulmonary Reactions (Transfusion Arm Only)||Measured within 6 hours after end of transfusion|Subjects who received granulocyte transfusions. Six subjects in the control group received granulocyte transfusions in violation of the protocol.||participants|||Number
121753|NCT00627393|Secondary|Alloimmunization, Defined as the Appearance of Anti-human Leukocyte Antigen (HLA) or Antineutrophil Antibodies||Measured at Days 14 and 42||||||
121754|NCT00627393|Primary|Percentage of Participants Who Are Alive at 42 Days After Treatment and Have Had Microbial Response|"Microbial response was defined as follows:~A negative blood culture test at 42 days after randomization for subjects with fungemia (candidemia or fusariosis) or bacteremia.~Improvement of signs and symptoms of infectious disease (complete or partial response) at 42 days after randomization."|Measured at Day 42|All adjudicated or deceased subjects in intention-to-treat analyses.||percentage of participants|||Number
121755|NCT00627094|Secondary|Adverse Events|Number of Adverse events reported which were evaluated to be related or possible related to the device|Continuously from start of treatment to end of trial (day 43)|||Number of AE|||Number
121756|NCT00627094|Secondary|Change From Baseline in Ulcer Area|Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)|Change from baseline to end of trial (day 43)|ITT population||Relative change from baseline in percent||Standard Deviation|Median
121757|NCT00627094|Secondary|Pain Intensity (PI) Change|Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).|Change from baseline in Pain Intensity (PI) on day 4 evening|PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock.||Change in PI since baseline||Standard Deviation|Mean
121758|NCT00627094|Primary|Pain Relief|The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.|Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)|ITT population||percentage of scores within category|Total Number of scores day 1-5||Number
121759|NCT00627042|Secondary|Number of Participants With Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered by the investigator to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.||participants|||Number
121760|NCT00627042|Secondary|Number of Participants With Serum Anti-Ramucirumab Antibodies||Prior to dosing at baseline, Cycles 4 and 7, and 30 days after end of therapy (1 cycle=2 weeks)|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.||participants|||Number
121761|NCT00627042|Secondary|Duration of Response|Duration of response was the interval from the date of initial documented response [complete response (CR) or partial response (PR)] to the first documented date of disease progression, initiation of other (or additional) antitumor therapy was first reported, or death due to any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target lesions, PR was having at least a 30% decrease in the sum of the longest diameter of target lesions, and disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data were censored for participants who did not progress or die.|Time of first response (CR or PR) to disease progression, or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Participants who received at least 1 dose of ramucirumab and had a CR or PR. The number of participants censored 2.||months||95% Confidence Interval|Median
121776|NCT00626925|Primary|Mean Heavy Drinking Days Per Week by Medication Group|Change in the number of heavy drinking days during treatment phase of study. Drinking data were aggregated to the weekly level. The number of days per week of heavy drinking (i.e., four or more drinks in a day for women and five or more drinks in a day for men) and of abstinence were the primary outcomes.|12 weeks (from initiation to end of treatment)|Intention to treat (ITT)||Number of heavy drinking days||Standard Error|Mean
121762|NCT00627042|Secondary|Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). As classified according to Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR was the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions. PR was having at least a 30% decrease in sum of longest diameter of target lesions.|First dose to date of objective progressive disease (PD) or death up to 18 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab.||percentage of participants||95% Confidence Interval|Number
121763|NCT00627042|Secondary|Overall Survival|Overall survival (OS) was the duration from first dose to death due to any cause. OS was censored at last contact date for participants who were alive at the end of follow-up period or lost to follow-up.|First dose to death due to any cause up to 37.5 months|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 10.||months||95% Confidence Interval|Median
121764|NCT00627042|Secondary|Time to Progression|The time from first day of therapy to the first date of objective evidence of progressive disease (PD) by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of new lesion. Time to PD was censored at the date of death or study discontinuation.|First dose to date of PD [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 20.||months||95% Confidence Interval|Median
121765|NCT00627042|Primary|Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer Treated With the Monoclonal Antibody Ramucirumab|PFS was defined as the time from the first day of therapy to the first evidence of disease progression or death from any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Participants who were alive and without disease progression and participants who did not progress and were subsequently lost to follow-up were censored at the last objective tumor assessment.|First dose to date of progressive disease or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]|Intent-to-treat population: Participants who received at least 1 dose of ramucirumab. The number of participants censored was 13.||months||95% Confidence Interval|Median
121766|NCT00627016|Secondary|Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.||Percentage of participants|||Number
121767|NCT00627016|Secondary|Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.|Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.|Last 7 days of treatment|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.||Percentage of participants|||Number
121768|NCT00627016|Primary|Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.|Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.|4 Weeks|Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who completed at least 1 diary entry for nighttime heartburn during treatment.||Percentage of nights||Inter-Quartile Range|Median
121769|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at End of Treatment|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|12 weeks (from initiation to end of treatment)|ITT||IU/L||Standard Deviation|Mean
121770|NCT00626925|Secondary|Gamma-glutamyl Transferase (GGT) at Midpoint|Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers.|6 weeks (from initiation to midpoint)|Subjects were measured at midpoint.||IU/L||Standard Deviation|Mean
121771|NCT00626925|Secondary|Severity of Alcohol-related Problems at End of Treatment|The Short Inventory of Problems (SIP). The SIP, a 15-item instrument, yields a total score that ranges from 0 to 45, higher score indicating higher levels of drinking problems. The SIP was derived from the Drinker Inventory of Consequences (DrInC), which was developed for use in Project MATCH (Miller and Tonigan 1995). We (Feinn et al. 2003) have found that, like the DrInC, the SIP measures a single factor of alcohol-related problems. Given that it is substantially shorter than the DrInC, we will use the SIP as a measure of alcohol-related consequences.|12 weeks (from intiation to end of treatment)|Subject were measured at Baseline and Endpoint.||units on a scale||Standard Deviation|Mean
121778|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121779|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121780|NCT00626808|Primary|Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0|Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121781|NCT00626808|Primary|Number of Outpatient Visits: 2 or More|Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121782|NCT00626808|Primary|Number of Outpatient Visits: 1|Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121783|NCT00626808|Primary|Number of Outpatient Visits: 0|Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121784|NCT00626808|Primary|Geographic Region: Western|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121785|NCT00626808|Primary|Geographic Region: Southern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121786|NCT00626808|Primary|Geographic Region: North Central|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121787|NCT00626808|Primary|Geographic Region: Northeastern|Geographic region of parents' residence among participants receiving FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121788|NCT00626808|Primary|Vaccinating Physician Specialty: Unknown|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
121789|NCT00626808|Primary|Vaccinating Physician Specialty: Other|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
121790|NCT00626808|Primary|Vaccinating Physician Specialty: General/Family Practitioner|Specialty of vaccinating physician who provided FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
121791|NCT00626808|Primary|Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist|Specialty of vaccinating physician who provided FluMist.|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of physicians|||Number
121792|NCT00626808|Primary|FluMist Use in Participants up to 59 Months of Age|Among participants up to 59 months of age who received any flu vaccine, number who received FluMist|2009-2010|General population of participants aged < 24 months, participants 24-59 months with asthma, participants 24-59 months with wheeing, and participants 24-59 months with immunosuppression.||Number of participants|||Number
121793|NCT00626782|Secondary|Efficacy|Mean change in intraocular pressure, number of glaucoma medications, bleb appearance based on the Indiana Bleb Appearance grading scale.|1 day, 2 wks, 1, 3, 6 and 12 months||||||
121794|NCT00626782|Primary|Adverse Events|Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs.|1 day, 2 wks, 1, 3, 6 and 12 months|||percentage of participants|||Number
121795|NCT00626743|Secondary|Maximal Change From Baseline in Standing DBP||within 8 hrs after SK3530 or placebo|||mmHg||Standard Deviation|Mean
121800|NCT00626639|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Questionnaire for Head and Neck Cancer [OMQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).~Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).||||||
121801|NCT00626639|Secondary|Number of Participants With Severe Oral Mucositis (OM) (Adapted RTOG/EORTC Grade ≥3)|"The adapted RTOG/EORTC mucositis assessment scale as follows: Grade 0 = no change; Grade 1 = mild enanthema, mild pain; Grade 2 = patchy mucositis, moderate edema, moderate pain; Grade 3 = confluent fibrinous mucositis, massive edema, massive pain; Grade 4 = extensive ulceration, confluent necrosis, massive hemorrhage.~Due to the small sample size this analysis was not performed."|Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).||||||
121802|NCT00626639|Primary|Ratio of Ki67-positive Cells Before and After Palifermin Treatment|The effect of palifermin on cell proliferation was to be assayed by staining for the cell cycle proliferation marker Ki67 in buccal mucosal biopsy samples taken prior to the first dose and either 24 or 48 hours after the first dose. Due to the small sample size, this analysis was not performed.|Day -3 predose and 24 or 48 hours post-dose||||||
121803|NCT00626639|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is an undesirable medical occurrence (sign, symptom, or diagnosis) or worsening of a pre-existing medical condition occurring after start of study drug up to the end of acute oral mucositis (OM) evaluation phase, whether or not considered to be study drug related. If severe OM was not resolved by Week 12, AEs were documented until resolution of severe OM or Week 15, whichever occurred first. A serious AE is any event that is fatal, life threatening, requires or prolongs hospitalization, is a persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3 based on the following: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death related to AE. A Protocol-specific Limiting Toxicity (PSLT) is any non-hematologic Grade 3 or 4 AE considered related to study drug.|Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)|||participants|||Number
121804|NCT00626574|Secondary|To Determine the Feasibility of Organizing a Larger, Randomized Study to Explore the Neuroprotective Effect of Procrit® in Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) When Procrit® is Administered Prior to Surgical Clipping of the Aneurysm.||When all data is collected and analyzed||||||
121805|NCT00626574|Secondary|To Determine if Procrit® Administration Prior to Aneurysm Clipping in Patients With Aneurysmal SAH Will Improve Neurological Assessment Scores in the Post-SAH/Post-clipping Time Period||First 10 days following clipping and 6 week f/u||||||
121806|NCT00626574|Secondary|To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping.||first 10 days following clipping and 6 week f/u||||||
121807|NCT00626574|Primary|Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping|Number of adverse events|First 10 days following clipping and 6 week F/U|Pilot Study- per protocol||adverse events|||Number
121808|NCT00626561|Primary|Progression-free Survival (PFS)|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Baseline to 6 Months, or until disease progression.|Interim analysis was to be done after 10 patients enrolled, accrual not met. Study halted early.|||||
121809|NCT00626548|Secondary|Time to Symptomatic Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks||||||
121810|NCT00626548|Secondary|Time to Prostate-specific Antigen (PSA) Progression||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks||||||
121811|NCT00626548|Secondary|Health Related Quality of Life||Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks||||||
121812|NCT00626548|Primary|Progression Free Survival|Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)||Participants|||Number
121813|NCT00626548|Primary|Overall Survival|Number of participants who have died at early analysis data cut off (DCO)|From date of randomization until date of death, assessed up to 33 months|The analysis population only includes patients recruited by the time of the early analysis (1 October 2010)||Participants|||Number
121814|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-6 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
121815|NCT00626522|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-3 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
121816|NCT00626522|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
121817|NCT00626522|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
122850|NCT00617903|Secondary|Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8 and 12|||Percentage of participants|||Number
121818|NCT00626522|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) for 0-12 hr||Baseline and treatment Week 4|ITT Population defined as all randomised patients who took at least one dose of investigational medicinal product and had at least the baseline and one post-baseline efficacy assessments||Liters||95% Confidence Interval|Least Squares Mean
121819|NCT00626444|Secondary|Duration of Response||10 weeks||||||
121820|NCT00626444|Primary|Progression-free Survival||10 weeks||||||
121821|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.||Percent suppressed||90% Confidence Interval|Number
121822|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation B: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation B. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/mL||Standard Error|Mean
121823|NCT00626431|Secondary|Mean (+/- Standard Error) Prostate Specific Antigen (PSA) at Baseline, Visits Throughout the Study, and at Final Visit for Formulation A: ITT Population|PSA levels were measured at baseline and each treatment visit for Formulation A. The mean (+/- standard error) was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Day 8, Week 14, Week 24, Week 30, Week 40, Week 48, and the Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/mL||Standard Error|Mean
121824|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
121825|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of luteinizing hormone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
121826|NCT00626431|Primary|Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted|The adjusted percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|||Percent Suppressed||90% Confidence Interval|Number
121827|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation B. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 h, 4 h, 8 h, 1 d, 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
121828|NCT00626431|Secondary|Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population|The acute-on-chronic effect is an agonistic stimulation of serum testosterone after the second depot injection of Formulation A. The mean +/- standard error changes were measured to assess this effect from just before to 2 weeks after the second injection.|Week 24 before the second injection until 2 weeks after Week 24 (2 hours [h], 4 h, 8 h, 1 day [d], 2 d, 3-10 d, and 11-17 d postdose)|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
121829|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population|Baseline was the last measurement before the first dose of Formulation B. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
121830|NCT00626431|Secondary|Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population|Baseline was the last measurement before the first dose of Formulation A. The mean +/- standard error was calculated at each visit. The final visit occurred at Week 48 unless the subject prematurely discontinued the study.|Baseline, Days 2 and 8, Weeks 2, 4, 8, 14, 20, 24, 26, 30, 34, 40, 46, 48, and Final Visit|The ITT population included subjects who received at least 1 dose of study drug, who had at least 1 postbaseline measurement, and who did not use prohibited medications during the first 32 days after the initiation of study drug treatment that either lowered testosterone levels or blocked its action.||ng/dL||Standard Error|Mean
121831|NCT00626431|Primary|Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint.|The percentage of subjects with testosterone suppression (<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.|Week 4 to Week 48|The ITT population for the primary endpoint was the same as the ITT population for the secondary endpoints and also excluded subjects whose final testosterone values were measured before Day 19 without suppression (>50 ng/dL) or whose testosterone levels remained suppressed through Week 48 but testosterone levels were not measured at Week 4.||Percent Suppressed||90% Confidence Interval|Number
121832|NCT00626392|Secondary|Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Number of Events per Subject per Week||Standard Deviation|Mean
121833|NCT00626392|Secondary|Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Scores on a Scale||Standard Deviation|Mean
121834|NCT00626392|Secondary|Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|4 weeks|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Percentage of Subjects|||Number
121835|NCT00626392|Primary|Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment|The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.|From Baseline to end of Week 1|All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).||Percentage of Subjects|||Number
121836|NCT00626327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The safety profile of MenACWY-CRM and MMRV vaccines when given concomitantly as compared to when MenACWY-CRM or MMRV was given alone is reported in terms of number of subjects reporting unsolicited adverse events (AEs), medically significant adverse events and serious adverse events (SAEs) after vaccination.|Day 1- Day 180 (Through out the study)|This analysis was done on the safety set population||Participants|||Number
121837|NCT00626327|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination|"Safety and tolerability of MenACWY-CRM and MMRV vaccines when given concomitantly compared to when either MenACWY-CRM or MMRV vaccine was administered alone is reported in terms of the number of subjects with local and systemic adverse events after vaccination.~Systemic reactions including axillary temperature reported during 28 days after vaccination at 12 months of age. These included the following systemic reactions: Measles-like rash, Rubella-like rash, Varicellalike rash, injection site rash, Mumps-like symptoms and axillary temperature."|upto 7 days after any vaccination|The analysis was performed on the safety set population||Participants|||Number
121838|NCT00626327|Secondary|Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine|The immunogenicity of one dose of MenACWY-CRM vaccine given at 7 to 9 months of age was assessed in terms of GMTs directed against N.meningitidis serogroups A, C, W-135, and Y.|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population||Titers||95% Confidence Interval|Geometric Mean
121839|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 and hSBA ≥1:8 after one dose of MenACWY-CRM vaccine (at 7-9 months), are reported|1 month post vaccine dose 1|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
121840|NCT00626327|Secondary|Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.|"The percentages of subjects showing seroconversion response to varicella after concomitant administration of MMRV vaccine (at 12 months) with MenACWY-CRM vaccine compared to when MMRV vaccine is given alone, is reported .~Seroconversion for varicella is defined as percentage of subjects who show pre-vaccination antibody titer <1.25 gp ELISA units/mL to a post-vaccination antibody titer ≥1.25 gp ELISA units/mL."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population||Percentages of subjects||95% Confidence Interval|Number
121841|NCT00626327|Secondary|Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.|The GMTs directed against measles, mumps, rubella and varicella, following one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.|6 weeks post vaccination|"The analysis was performed on the MMRV per-protocol population.~Only subjects with a baseline titer below the specified cut-off for that antigen were included in the immunogenicity analysis for the same antigen."||Titers||95% Confidence Interval|Geometric Mean
121842|NCT00626327|Secondary|Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine|The geometric mean titers (GMTs) directed against N.meningitidis serogroups A, C, W-135 and Y, following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months of age), when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population||Titers||95% Confidence Interval|Geometric Mean
121843|NCT00626327|Secondary|Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine|The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
121844|NCT00626327|Primary|Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine|The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.|6 weeks post vaccine dose 2|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
121845|NCT00626327|Primary|Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.|"Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.~The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA).~The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup."|6 weeks post second dose|The analysis was performed on the MenACWY per-protocol population||Percentages of subjects||95% Confidence Interval|Number
121846|NCT00626327|Primary|Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine|"Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.~Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella.~Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and –10% (varicella)."|6 weeks post vaccination|The analysis was performed on the MMRV per-protocol population||Percentages of subjects||95% Confidence Interval|Number
121847|NCT00626275|Primary|"Part B: The Mean of Daily Average Now Lower Extremity Pain Intensity (LEPI) Score During the 2-Week Period"|"Participants assessed their “Now” LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.~LS means and SE were calculated from an analysis-of-covariance model with effect for treatment and baseline “Now” LEPI (before dosing for Treatment Period 1 of Part A) as a covariate. Participants with no postbaseline assessments were excluded from the baseline summary."|Baseline through 2 Weeks|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Error|Least Squares Mean
121848|NCT00626275|Secondary|Part A: Participant’s Global Evaluation of Study Medication|For each treatment period during Part A, each participant’s global evaluation (overall impression) of study medication was obtained 6 hours after dosing. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from “excellent” to “poor”. Participant counts per score were reported once in Part A.|6 hours post dose during Treatment Periods 1, 2, and 3 of Part A|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||participants|||Number
121895|NCT00625872|Secondary|Mean Height at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
121849|NCT00626275|Secondary|Part B: Percentage of Participants Using Rescue Medication|The percentage of participants who took at least 1 dose of rescue medication during 2-week treatment period of Part B is presented.|Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||Percentage of Participants|||Number
121850|NCT00626275|Secondary|Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period|During Part B, participants returned to the clinic for 2 additional visits at approximately weekly intervals for assessments of Overall Pain Index (OPI). Participants rated their OPI on an 11-point Numeric Pain Rating Scale (NPRS) with 0 indicating No Pain and 10 indicating Worst possible pain|Baseline through Week 1, Week 1 through Week 2, and Baseline through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
121851|NCT00626275|Secondary|Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2|Each day during Part B, participants rated their Lower Extremity Pain Intensity over the last 24 hours on an 11-point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain|Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
121852|NCT00626275|Secondary|Part B: Participants’ Global Evaluation of Study Medication|For Part B, each participant’s global evaluation (overall impression) of study medication was obtained at each weekly visit. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from “excellent” to “poor”. Participant counts per score were reported at Week 1 (Day 7) and Week 2 (Day 14).|Up to Week 1 and Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||Participants|||Number
121853|NCT00626275|Secondary|Part A: Percentage of Participants in Each Treatment Group Achieving a 25%, 50%, or 75% Reduction From Baseline in Evoked Lower Extremity Pain Intensity Scores|Percentage was measured by identifying the number of participants who achieved the desired percentage Reduction From Baseline in ELEPI Score at either 2, 4, and 6 hours post dose and was divided the by the number of total participants in the given group and then multiplied by 100 to equate to a percentage.|Up to 2, 4, and 6 hours post dosing|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||Percentage of Participants|||Number
121854|NCT00626275|Secondary|Part A: Mean Peak Difference in ELEPI According to the NPRS Scale|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point NPRS. Participants were asked to rate their lower extremity pain on an 11 point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Peak ELEPID was defined as the maximum of ELEPIDs recorded at 2, 4, and 6 hours post dose. Difference = predose (baseline) NPRS score - peak NPRS score up to 6 hours post dose.|Baseline, Up to 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
121855|NCT00626275|Secondary|Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing|Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Difference = predose (baseline) ELEPI score - ELEPI score 4 hours post dose.|Baseline, 4 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose||units on a scale||Standard Deviation|Mean
121856|NCT00626275|Secondary|Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain|Overall Pain Intensity (OPI) was assessed by the participant using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours after dosing. Difference = predose (baseline) OPI score - OPI score 6 and 12 hours post dose.|Baseline, 6 and 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
121857|NCT00626275|Secondary|Part B: Mean Daily LEPI Scores for Weeks 1 and 2|Participants assessed their “Now” LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.|Baseline through Week 1 and Week 1 through Week 2|Participants in Part B who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
121858|NCT00626275|Secondary|Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain|Overall Pain Intensity (OPI), “Now” Lower Extremity Pain Intensity (LEPI), and Evoked Lower Extremity Pain Intensity (ELEPI) were assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours (hr) after dosing. At 15 minutes before dosing, during Period 1 only, participants were also asked to assess their average LEPI over the last 24 hours as a baseline measurement. “Now” LEPI was assessed at 15 minutes before dosing for baseline and at the 1-, 2-, 3-, 4-, 5-, 6-, and 12-hour time points. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then (after the “Now” LEPI assessment) he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI.|Baseline up to 12 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Deviation|Mean
121859|NCT00626275|Primary|Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) Lower-Extremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing|"Approximately 1 hour before baseline and again approximately 45 minutes before the 2-, 4-, and 6-hour time points, participants rested for 45 minutes, then they started the treadmill walk at 15 minutes before baseline and at the 2-, 4-, and 6-hour time points. After the treadmill walk, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. The average difference between baseline and 6 hours post dose evoked lower-extremity pain intensity scores (AELEPID-6) is presented for each treatment group. Difference = predose (baseline) NPRS score - NPRS score 6 hours post dose.~Least square (LS) means and standard errors (SE) were calculated from an analysis-of-covariance (ANCOVA) model with fixed effects for sequence, treatment, period, predose evoked lower extremity pain intensity as a covariate, and a random effect for participant nested within sequence."|Baseline through 6 hours post dose|Participants in Part A who received at least 1 dose of study drug and had at least 1 pain intensity assessment post dose.||units on a scale||Standard Error|Least Squares Mean
121860|NCT00626210|Secondary|Improvement of Daytime Alertness and Quality of Life.||~1 month||||||
121861|NCT00626210|Primary|Nocturnal Sleep Length at 1 Month||1 month|||hours||Full Range|Median
121862|NCT00626093|Secondary|Defibrillation Threshold Difference Obtained in Joules (J)||Baseline and 6 months|||Joules||Standard Deviation|Mean
121863|NCT00626093|Primary|Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months|All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.|Baseline and 6 months|||Volts||Standard Deviation|Mean
121864|NCT00626028|Secondary|Surgical Procedures at 3 Years|The 3 year follow-up survival assessment consisted of a telephone call to subjects to obtain information on surgeries received pertaining to pulmonary or cardiac disease|3 years after treatment|||Participants with surgical procedures|||Number
121865|NCT00626028|Secondary|Serious Adverse Events||12 hours after discontinuation of gas or dischange (whichever comes first)||||||
121866|NCT00626028|Secondary|Adverse Events||treatment 1 through treatment 3||||||
121867|NCT00626028|Secondary|Surgical Procedures at 1 Year|The 1 year follow-up survival assessment consisted of a telephone call to subjects to obtain information on surgeries received pertaining to pulmonary or cardiac disease|1 year after treatment|||Participants with surgical procedures|||Number
121868|NCT00626028|Primary|Reversible Pulmonary Hypertension (Vasoreactivity)as Defined by Hemodynamic Measurements|Hemodynamic measurements (heart rate, systolic arterial blood pressure,diastolic arterial blood pressure, mean arterial pressure, mean central venous pressure, systolic pulmonary arterial pressure, diastolic pulmonary arterial pressure, mean pulmonary wedge pressure and cardiac output) were used to measure reversible pulmonary hypertension (vasoreactivity).|1 year|One hundred thirty six participants were enrolled (intent-to-treat population), 124 received study drug.||Participants|||Number
121869|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||72 hrs||||||
121870|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||24 hrs||||||
121871|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant||7 hrs||||||
121872|NCT00625989|Secondary|The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant.||Before inhalation (0hrs)||||||
121873|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs|||number of cells/g of sputum||Standard Deviation|Mean
121874|NCT00625989|Primary|The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells|Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.|24 hrs|||number of cells/g of sputum||Standard Deviation|Mean
121875|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||mm||Standard Error|Least Squares Mean
121876|NCT00625872|Secondary|Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6|Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||Millimeter (mm)||Standard Error|Least Squares Mean
121877|NCT00625872|Secondary|Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion). The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
121878|NCT00625872|Secondary|Change From Baseline in Head Circumference at Months 6, 12 and 18|The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
121879|NCT00625872|Secondary|Body Mass Index-Standard Deviation Score (BMI-SDS)|The BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg) divided by the height (m) squared. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
121880|NCT00625872|Secondary|Sitting Height-Standard Deviation Score (SDS)|Sitting height was measured using a stadiometer with a specialized chair. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
121881|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.||m/s||Standard Error|Least Squares Mean
121882|NCT00625872|Primary|Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Vmax was measured by Leonardo Jumping Platform during two-leg jump.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Meter/second (m/s)||Standard Error|Least Squares Mean
121883|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.||Newtons||Standard Error|Least Squares Mean
121884|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm/year||Standard Error|Least Squares Mean
121885|NCT00625872|Secondary|Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||cm/year||Standard Error|Least Squares Mean
121886|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Error|Least Squares Mean
121887|NCT00625872|Secondary|Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Error|Least Squares Mean
121888|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18||Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm/year||Standard Deviation|Mean
121889|NCT00625872|Secondary|Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6|Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm/year||Standard Deviation|Mean
121890|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
121891|NCT00625872|Secondary|Mean Height-Standard Deviation Score (SDS) at Month 6|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm||Standard Deviation|Mean
121892|NCT00625872|Secondary|Mean Growth Velocity at Months 12 and 18|Growth velocity measures the annual rate of increase in height.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm/year||Standard Deviation|Mean
121893|NCT00625872|Secondary|Mean Growth Velocity at Month 6|Growth velocity measures the annual rate of increase in height.|Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||cm/year||Standard Deviation|Mean
121894|NCT00625872|Secondary|Mean Height at Months 12 and 18|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.|Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
121896|NCT00625872|Secondary|Mean Calf Circumference|Calf measurements were taken as a mean of 3 consecutive measurements at largest part of calf muscle, usually about 4 inches down from below the knee.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
121897|NCT00625872|Secondary|Mean Thigh Circumference|Thigh measurements were taken as a mean of 3 consecutive measurements at upper thigh about an inch down from the crotch line.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||cm||Standard Deviation|Mean
121898|NCT00625872|Secondary|Mean Upper Arm Circumference||Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||centimeter (cm)||Standard Deviation|Mean
121899|NCT00625872|Other Pre-specified|Change From Baseline in Bone Stability Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone stability was measured by pqCT. Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- (or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||z-score||Standard Error|Least Squares Mean
121900|NCT00625872|Other Pre-specified|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone structure was measured by pqCT.Parameters included:total area,cortical area,marrow area,cortical thickness,cortical density of the radius,bone strength,cross-sectional muscle and fat area,total bone density,bone mineral count,trabecular BMD,bone cross-sectional area.Baseline and post-baseline SDS values transformed to age and sex specific z-score([Ln(test result/M)]/S);Ln=natural logarithm;M=age-/height- and sex-specific mean value;S=age-/height- and sex-specific coefficient of variation).Positive values are above the average for participant’s age and sex;negative values are below.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||z-score||Standard Error|Least Squares Mean
121901|NCT00625872|Other Pre-specified|Change From Baseline in Bone Density Using Peripheral Quantitative Computed Tomography (pqCT) at 6 or 12 or 18 Months|Bone Mineral Density (BMD) was measured by pqCT. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population and more positive scores indicate higher BMD compared to age matched population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||z-score||Standard Error|Least Squares Mean
121902|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kg||Standard Error|Least Squares Mean
121903|NCT00625872|Secondary|Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6|MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||kg||Standard Error|Least Squares Mean
121904|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||seconds||Standard Deviation|Mean
121905|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kN||Standard Deviation|Mean
121906|NCT00625872|Secondary|Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kW||Standard Deviation|Mean
121916|NCT00625872|Secondary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during one leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Newtons||Standard Deviation|Mean
121907|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||seconds||Standard Deviation|Mean
121908|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6|Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||seconds||Standard Deviation|Mean
121909|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||m/s||Standard Deviation|Mean
121910|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||m/s||Standard Deviation|Mean
121911|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kN||Standard Deviation|Mean
121912|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||kilonewton (kN)||Standard Deviation|Mean
121913|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||kW||Standard Deviation|Mean
121914|NCT00625872|Secondary|Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6|The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||kilowatt (kW)||Standard Deviation|Mean
121915|NCT00625872|Secondary|Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18|Vmax was measured by Leonardo Jumping Platform during one leg jump.|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||m/s||Standard Deviation|Mean
121947|NCT00625404|Primary|Confirmed Grade 3 or Higher AST Elevation|Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product|||participants|||Number
121917|NCT00625872|Secondary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during one leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline, Month 6 , Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||W/kg||Standard Deviation|Mean
121918|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18|CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years’ checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).|Baseline, Month 6, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Units on a scale||Standard Deviation|Mean
121919|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Units on a scale||Standard Deviation|Mean
121920|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6|"NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} Yes answers(1);sum of C Yes answers(2);sum of IC Yes answers(3);sum of differences of C-IC Yes answers with high associative items{ 87%-95%}(4);sum of differences of C-IC Yes answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Units on a scale||Standard Deviation|Mean
121921|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Seconds||Standard Deviation|Mean
121922|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6|"The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); Sustained Attention, change of reaction (Flexibility); Divided Attention, controlled reaction disposition (Go/No go) and Vigilance. It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results."|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure and 'n' signifies participants who received the study drug and evaluated at the time point for each group respectively.||Seconds||Standard Deviation|Mean
121923|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline, Month 12 and Month 18|Data were not analyzed as study was prematurely terminated due to insufficient number of participants.||Units on a scale||Standard Deviation|Mean
121924|NCT00625872|Secondary|Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6|K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.||Units on a scale||Standard Deviation|Mean
121948|NCT00625404|Primary|Confirmed Grade 3 or Higher ALT Elevation|Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal|Through 52 weeks on product and 4 weeks post-product|||participants|||Number
126951|NCT00578812|Secondary|Mean SF-36 Mental Component Summary (MCS)|Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per Protocol||units on a scale||Standard Deviation|Mean
121925|NCT00625872|Primary|Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Newtons||Standard Error|Least Squares Mean
121926|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6|PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|PP population included participants who received the study medication for at least 22 weeks. Number of participants analyzed (N) signifies participants evaluable for the measure.||W/kg||Standard Error|Least Squares Mean
121927|NCT00625872|Primary|Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6|Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.|Baseline and Month 6|FAS population included participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment. Number of participants analyzed (N) signifies participants evaluable for the measure.||Watt/kilogram (W/kg)||Standard Error|Least Squares Mean
121928|NCT00625820|Secondary|Estimated Glomerular Filtration Rate (eGFR) Measured at 6 and 12 Weeks of Therapy.||12 weeks|||ml/min/1.73m2||Standard Deviation|Mean
121929|NCT00625820|Secondary|Systolic Blood Pressure Measured at 6 and 12 Weeks of Therapy.||12 weeks|||mmHG||Standard Deviation|Mean
121930|NCT00625820|Primary|The Primary Outcome Measure is Level of Albuminuria.|Early morning urine specimens were collected to calculate albumin and creatinine ratio (albuminuria) at 6 and 12 weeks of therapy.|12 weeks|All participants who finished the trial were analyzed||ratio||Standard Deviation|Mean
121931|NCT00625742|Secondary|Improvement of Clinical Outcomes|Improvement of clinical outcomes such as strength and function between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.|||||
121932|NCT00625742|Primary|Participant Gain in Lean Body Mass|Measure increases in lean body mass in individuals with cancer who experience cachexia between baseline and day 29 (+/- 3 days).|Baseline to Day 29, approximately 30 days|Only 3 patients completed the study and were evaluable for analysis, others were unable to follow the study exercise and intervention elements. There were insufficient data points collected to analyze.|||||
121933|NCT00625729|Secondary|Number of Patients With Overall Survival|Number of patients alive at 6 months after treatment.|6 Months|||Participants|||Number
121934|NCT00625729|Secondary|Number of Patients With Adequate Natural Killer Cells Infused|Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg).|Day 0|||Participants|||Number
121935|NCT00625729|Secondary|Number of Patients Whose Disease Progressed After Treatment|Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment.|6 Months|Only patients who responded to treatment included in the analysis.||Participants|||Number
121936|NCT00625729|Secondary|Number of Patients With Overall Response|Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia|3 Months|||Participants|||Number
121937|NCT00625729|Secondary|Number of Patients With Interleukin-15 Production and NK Cell Expansion|Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion|Day 0|Correlation of interleukin-15 with Natural Killer Cell expansion cannot be calculated because there was no Natural Killer Cell expansion.||Participants|||Number
121938|NCT00625729|Primary|Number of Patients Exhibiting Natural Killer Cell Expansion|Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population.|Day 14|||Participants|||Number
121939|NCT00625586|Primary|Proportion of Patients Alive at 8 Months||8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
121940|NCT00625586|Secondary|Cmax|RAV12 and gemcitabine cmax|29 days||||||
121941|NCT00625586|Secondary|Adverse Events|Frequency of adverse events and serious adverse events|any timeframe following study drug up to 3 years||||||
121942|NCT00625586|Secondary|Overall Survival||three years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
121943|NCT00625586|Secondary|Progression-free Survival||time to progression or death, up to 3 years|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
121944|NCT00625586|Secondary|Partial Response and Complete Response Rates|Based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0; partial response = 30% decrease in sum of longest diameter. complete response = 100% decrease in sum of longest diameter. Rate of response = proportion of complete or partial responses based on number of patients evaluated.|8 months|Study was terminated after 2 patients enrolled therefore no statistical analyses were performed.|||||
121945|NCT00625586|Secondary|Proportion of Patients Alive at 12 Months||12 months||||||
121946|NCT00625404|Secondary|Participant Report of Change in Number of Sexual Partners|Difference in mean number of reported sexual partners between final study visit and enrollment visit|Up to 52 weeks|Women reporting on sexual behavior during follow-up||mean number of sexual partners||Standard Deviation|Mean
121950|NCT00625404|Secondary|Pill Counts and Participant Report of Adherence to Once-daily Pill Taking|Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts|Up to 52 weeks|All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment||percentage of days||Standard Deviation|Mean
121951|NCT00625404|Secondary|Pregnancy Complications|Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications|up to 60 weeks|Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)||participants|||Number
121952|NCT00625404|Secondary|FTC and/or Tenofovir Resistance|"Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).~participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time."|up to 52 weeks|All women who seroconverted were assessed for possible resistance.||participants|||Number
121953|NCT00625404|Secondary|CD4+ T-cell Count|CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks|Up to 16 weeks|||cells/mL||Standard Deviation|Mean
121954|NCT00625404|Secondary|Plasma HIV RNA Level (HIV-1 Viral Load)|Viral load at the time of HIV detection, HIV conversion and through 16 weeks|up to 16 weeks|68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit||log copies/mL||Standard Deviation|Log Mean
121955|NCT00625404|Primary|Frequency and Nature of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration||10-26 months per site||||||
121956|NCT00625404|Primary|Confirmed Grade 2 or Higher Serum Creatinine Toxicity|Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal|cumulative toxicity through 52 weeks of product use and 4 weeks post product|The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.||participants|||Number
121957|NCT00625404|Primary|HIV Infection|HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.|Cumulative HIV infection between enrollment and 52 weeks|All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population||participants|||Number
121958|NCT00625391|Secondary|Oxidative Stress Damage Biomarker|Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test|24 weeks|Analyzed who completed the study.||ng/mg creatinine||Standard Deviation|Mean
121959|NCT00625391|Primary|Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker|Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP)|24 weeks|Analyzed on those who completed the study. Percent change relative to the baseline for each group.||percentage change from baseline||Standard Deviation|Mean
121960|NCT00625365|Secondary|Adverse Events|Summary of the number and percentage of participants with adverse events occuring following completion of DEFINITY administration|Through 24 hours|||Participants|||Number
121961|NCT00625365|Secondary|Serious Adverse Events|Summary of the number and percentage of participants with serious adverse events occuring following completion of DEFINITY administration|Through 24 hours|||Participants|||Number
121962|NCT00625365|Primary|The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration||during or within 30 minutes of administration|The safety population was analyzed per the protocol||Participants|||Number
121963|NCT00625183|Secondary|Distant Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
121964|NCT00625183|Secondary|Local Relapse Rate||For up to 5 years following surgery.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
121965|NCT00625183|Secondary|Dose Intensity||During treatment with capecitabine, oxaliplatin, selenomethionine.||||||
121966|NCT00625183|Secondary|Safety and Tolerability as Assessed by NCI CTCAE Version 3.0||Adverse events were queried for and collected every cycle for the duration of treatment.||||||
121967|NCT00625183|Primary|Rate of T-downstaging With Capecitabine, Oxaliplatin, Selenomethionine, and Radiotherapy||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
121968|NCT00625183|Primary|Complete Pathological Response Rate||After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.|Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.|||||
121969|NCT00625131|Secondary|Smoking Craving|"Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment. This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period. The craving score is based on a single diary item Please rate your desire to smoke right now with a Likert scale score ranging from 1 (none) to 5 (severe). Higher craving is worse, as lower craving is presumed to reflect decreased risk of smoking lapse or relapse."|Daily between visits 2-12|||units on a scale||Standard Deviation|Mean
121970|NCT00625131|Secondary|Carbon Monoxide Monitoring|Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)|Session 12 (6 weeks post-treatment)|Please note that this secondary outcome (bioverification by CO reading) is not a measure of complete smoking abstinence during the study period (or during the week prior to the session - see Primary Outcome). It is independent of self-reported smoking abstinence. It is not unexpected that CO readings different than self-reported smoking.||participants|||Number
121971|NCT00625131|Primary|Smoking Abstinence, Self-reported|Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment|Week prior to Session 12 at 6 weeks post-treatment|Any participants who did not attend Session 12 for any reason (i.e., lost to contact, withdrawn after beginning treatment) were counted as smoking (i.e., intent-to-treat analyses, missing = smoking).||participants|||Number
121972|NCT00624832|Secondary|Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"Late-phase allergic response (LAR) was only determined for those patients who had an LAR >= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the best post saline (Control) FEV1 was used. LAR (%) = 100*[FEV1 (0) - Minimum FEV1 (3-8h)]/FEV1 (0)."|Week 0, Week 8 and Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.||Percentage of LAR||Standard Deviation|Mean
121973|NCT00624832|Primary|Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients|"The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge:~EAR = 100* [ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)] / FEV1 (0). For FEV1 (0), the ”best post saline (Control) FEV1” was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate."|Week 8, Week 16|Safety and Pharmacodynamic (PD) population. Although all patients had baseline EAR not all of them had a value determined for week 8 and 16 reducing the number evaluable for analysis particularly at week 8. Patients of first 2 Xolair groups received placebo treatment were pooled in one placebo group for analysis. No analysis on third Xolair groups.||Percentage of EAR||Standard Error|Least Squares Mean
121974|NCT00624806|Primary|Percent of Participant Triggering DMP Items|Percent of participants who triggered Disease-Management Protocol items by group.|Enrollment to study end, 8 weeks|||% of participants triggering an item|Participants||Number
121975|NCT00624806|Primary|Number of Days With Triggers at Certain Timeframe|Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.|Enrollment to study end, 8 weeks|||days|Participants||Number
121976|NCT00624806|Primary|Days of Data|Data includes the number of triggered items and types of triggers.|Enrollment to study end, 8 weeks|||days||Full Range|Mean
121977|NCT00624780|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)|Safety analysis set: all randomized participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for this measure during each specified period, for each group respectively.||participants|||Number
121978|NCT00624780|Other Pre-specified|Sheehan-Suicidality Tracking Scale (S-STS) Score|Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency.|Baseline up to Week 24|Data was not statistically summarized but was available in individual participant listings and mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) due to change in planned analysis.|||||
121979|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121980|NCT00624780|Secondary|Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121981|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121982|NCT00624780|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121983|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 2|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121984|NCT00624780|Secondary|Clinical Global Impression - Severity (CGI-S) Score for Period 1|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121985|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121986|NCT00624780|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
121987|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 24|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121988|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Period 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 12|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Last observation carried forward (LOCF) method was used to impute missing values.||units on a scale||Standard Deviation|Mean
121989|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121990|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121991|NCT00624780|Secondary|Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121992|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N(Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121993|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
122079|NCT00624052|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
126952|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)|Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.|24 Months|Per Protocol||participants|||Number
121994|NCT00624780|Secondary|Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121995|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121996|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121997|NCT00624780|Secondary|Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121998|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’=participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
121999|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
122000|NCT00624780|Secondary|Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
122001|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.||participants|||Number
122002|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 1: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.||participants|||Number
122003|NCT00624780|Secondary|Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)|DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis.||participants|||Number
122004|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
122005|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
122006|NCT00624780|Secondary|Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)|Rebound anxiety was defined as a rapid return of the participant’s original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.|2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
122007|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
122008|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
122009|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
122010|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
122011|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
122012|NCT00624780|Primary|Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. ‘n’ = participants evaluable at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
122013|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
122014|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis.||units on a scale||Standard Deviation|Mean
122015|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
122016|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.||units on a scale||Standard Deviation|Mean
122017|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
122018|NCT00624780|Primary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.|Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)|Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included. n=participants evaluable at given time points for each group.||units on a scale||Standard Deviation|Mean
122019|NCT00624585|Secondary|Number of Participants With Stable Disease (SD)||1 Year 4 Months|All Participants||participants|||Number
122020|NCT00624585|Secondary|Number of Participants With Partial Remission (PR)|Partial remission (PR) (modified IWG); IWG = International MDS Working Group. All of the CR criteria (if abnormal prior to treatment), except: Bone marrow evaluation: Blasts decreased by ≥ 50% over pretreatment but still >5%. Cellularity and morphology are not relevant.|1 Year 4 Months|All Participants||participants|||Number
122021|NCT00624585|Secondary|Number of Participants With Hematologic Improvement|Hematologic improvement in platelets, red blood cell (RBC), neutrophils according to modified IWG Criteria; Cytogenetic response (modified IWG); Change in percentage of blasts in bone marrow and peripheral blood; Src-Tyr416 phosphorylation in medullary myeloblasts. Hematologic improvements must last ≥ 8 weeks.|1 Year 4 Months|All Participants||participants|||Number
122022|NCT00624585|Primary|Number of Participants With Marrow Complete Remission (CR)|"Complete remission (modified IWG); IWG = International MDS Working Group.~Bone Marrow Response must last ≥4 weeks. Bone marrow evaluation: Bone marrow showing ≤5% myeloblasts with normal maturation of all cell lines."|1 Year 4 Months|All Participants||participants|||Number
122023|NCT00624559|Secondary|Urinary Sodium Excretion|Urine collected over 24 hour period on last day of each different sodium diet|24 hour|||mmol Na+/24 hr||Standard Error|Mean
122024|NCT00624559|Primary|Mean Arterial Pressure|Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor|24 hours|||mm Hg||Standard Error|Mean
122025|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Anger-recall Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress of anger-recall task. Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The anger-recall test was applied for 25 minutes with 10 minutes monitoring post-test. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect"|Immediate to 6 months post intervention|Response to Mental Stress by Anger-Recall Stress Task||mmHg x beats/minute||Standard Error|Mean
122026|NCT00624520|Primary|Mental Stress Induced Elevation in Double Product by Math Stress Task|"Maximum Mental Stress induced elevation in Double Product , DP, (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress tasks of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|3 months post intervention|Response to mental stress by math task testing at 3 months post intervention, compared with pre-intervention. Within-group comparison is shown for matched pair data. The lower number of participants analyzed than at study entry is due to patient drop-outs during follow-up post-intervention.||mmHg x beats/minute||Standard Error|Mean
122027|NCT00624520|Secondary|Cardioverter-DefibrillatorTherapies|Cardioverter-Defibrillator therapies for treatment of serious ventricular arrhythmia|6 months post intervention|Cardioverter-defibrillator interrogation data between 3 and 6 months post intervention||percentage of participants|||Number
122028|NCT00624520|Secondary|Low Frequency/High Frequency Ratio of Heart Rate Variability|Heart Rate Variability measure of cardiac autonomic activity Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Decreased Low/High Frequency ratio reflects Increased High Frequency heart rate variability which correlates with increased cardiac parasympathetic activity, which may be beneficial in this patient population. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|"Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for heart rate variability analyses during follow-up, with inclusion only of participants having accurate and appropriate data.~Data are shown for Ratios of Low and High Frequency power shown above."||Ratio||Standard Deviation|Mean
122029|NCT00624520|Secondary|High Frequency Heart Rate Variability|Heart Rate Variability measure of Cardiac Parasympathetic activity. Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Increased High Frequency heart rate variability correlates with increased cardiac parasympathetic activity. Normalized units are used, reflecting percentage of total frequency power.|6 months post intervention|Reduced participant numbers reflect drop-outs and exclusion of participants with non-diagnostic recordings for HRV analyses, with inclusion only of participants having accurate and appropriate data.||percentage of spectral power||Standard Deviation|Mean
122030|NCT00624520|Secondary|Low Frequency Heart Rate Variability|"Heart Rate Variability measure of cardiac autonomic activity, believed to reflect a combination of cardiac sympathetic and parasympathetic activity.~Data are derived from ambulatory ECG recordings during serial mental stress testing (math and anger-recall tasks) using a General Electric MARS Holter analysis system. Time series are created from beat-to-beat intervals, from which frequency domain measures are calculated. Low frequency heart rate variability correlates with cardiac sympathetic and parasympathetic activity. Increased sympathetic activity and/or decreased parasympathetic activity occur in this study population at high risk for cardiac arrhythmia. Normalized units are used, reflecting percentage of total frequency power."|6 months post intervention|6 months post intervention, from ECG recordings during mental stress tasks Reduced numbers of participants analyzed reflect drop-outs or non-diagnostic recordings for HRV analyses during follow-up, with inclusion only of participants having accurate and appropriate data.||percentage of spectral power||Standard Deviation|Mean
122031|NCT00624520|Secondary|Depression/Dejection|Psychometric score from self-report questionnaire Scale range is 9 to 60. Lower values represent better outcome, and higher values represent worse outcome..|3 months post intervention|3 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up,with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
122032|NCT00624520|Secondary|Perceived Stress|Psychometric score from self-report questionnaire Scale range is 2-27. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
122033|NCT00624520|Secondary|Tension/Anxiety|Psychometric score by self-report questionnaire Scale range is 3-29. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Immediate post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
122034|NCT00624520|Secondary|State Anger|Psychosocial score of negative mood derived from self-report questionnaires. Scale range was 15-45. Lower values represent better outcome, and higher values represent worse outcome..|Immediate post intervention|Serial psychometric scores up to 6 months post intervention Reduced numbers of participants analyzed reflect drop-outs or failure to fully complete questionnaires during follow-up, with inclusion only of participants having accurate and appropriate data.||units on a scale||Standard Deviation|Mean
122035|NCT00624520|Primary|"Mental Stress Induced Elevation in Double Product by Math Stress Task"|"Maximum Mental Stress induced elevation in Double Product , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minutes recovery time. An average of 3 measurements was taken as baseline prior to stress tasks. Stress induced double product elevations were measured as the difference between baseline and maximal values in units of mmHg.beats/minute. Higher values represent a greater mental stress induced effect, and lower values, a lower effect."|Immediate to 6 months post intervention|Response to Mental Stress by Math Stress Task.||mmHg x beats/min||Standard Error|Mean
122036|NCT00624468|Secondary|Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack|Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature [axillary, orally or intraauricularly] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.|From baseline (Study Day 1) up to Week 36|ITT population included all randomized participants.||percentage of participants|||Number
122037|NCT00624468|Secondary|Contrast Sensitivity: Score Line|Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||units on a scale||Standard Deviation|Mean
122038|NCT00624468|Secondary|Contrast Sensitivity: Total Number of Letters Correctly Identified|Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||letters||Standard Deviation|Mean
122039|NCT00624468|Secondary|Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified|Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||letters||Standard Deviation|Mean
122040|NCT00624468|Secondary|Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36|The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||cubic micrometer||Standard Deviation|Mean
122041|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
122042|NCT00624468|Secondary|Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36|The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.|Baseline, Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
122043|NCT00624468|Secondary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.|Baseline, Weeks 12 and 24|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
122080|NCT00624052|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
122044|NCT00624468|Secondary|Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.|Weeks 12, 24 and 36|"ITT population included all randomized participants. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."||micrometer||Standard Error|Mean
122045|NCT00624468|Primary|Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)|The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.|Baseline, LOV (Week 48)|"ITT population included all randomized participants. Here, n signifies those participants who were evaluable for the specified category."||micrometer||Standard Deviation|Mean
122046|NCT00624442|Secondary|Pharmacokinetics of CK-1827452 Injection in Stable Heart Failure Patients||2 days||||||
122047|NCT00624442|Primary|Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.||Percentage of change||Standard Error|Least Squares Mean
122048|NCT00624442|Primary|Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations|Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.|4 days|Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.||msec||Standard Error|Least Squares Mean
122049|NCT00624416|Secondary|The Number of Subjects Elected to Have the Lipoma Removed.||After four weeks up to one year.|||participants|Participants||Number
122050|NCT00624416|Secondary|The Number of Lipoma Increased in Volume.||After four weeks of treatment up to one year.|||Lipomas|Participants||Number
122051|NCT00624416|Primary|The Average Percent Volume Reduction in the Lipoma.||Baseline and 4 weeks|||Percent Volume reduction (cc^3)|Participants|Full Range|Mean
122052|NCT00624377|Secondary|Percentage of Participants Which Had a Reduction of Concomitant Drug Use|The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.|8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Percentage of Participants|||Number
122053|NCT00624377|Secondary|Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
122054|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
122055|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
122081|NCT00624052|Secondary|Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in SBP in this study|Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
123002|NCT00617188|Secondary|Urine N-telopeptide Concentration|Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.|Baseline, 1 Month, 3 Months, 6 Months|||Units of Bone Collagen Equivalents/mmol||Full Range|Median
122056|NCT00624377|Secondary|Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
122057|NCT00624377|Primary|Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment|FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75–80%. In obstructive diseases, the value often decreased (<80%, often ~45%).|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Ratio||Standard Deviation|Mean
122058|NCT00624377|Primary|Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment|FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 < 80% of the predicted value in combination with an FEV1/FVC < 70% confirms the presence of airflow limitation that is not fully reversible|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||liter per second||Standard Deviation|Mean
122059|NCT00624377|Primary|Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment|"The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?"|Baseline and 8 weeks|"Safety population:~Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population.~Complete population:~Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population."||Units on a Scale||Standard Deviation|Mean
122060|NCT00624338|Secondary|Mean Cumulative Corticosteroid Dose||Randomization up to Week 52|MITT population included all the randomized participants who received study treatment.||mg||Standard Deviation|Mean
122061|NCT00624338|Secondary|Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares|"Ordinal response categories have been defined as: 1) No BILAG A, no BILAG B, and completed treatment, 2) No BILAG A, at least 1 BILAG B during treatment period, and 3) At least 1 BILAG A during treatment period. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|Week 52|MITT population included all the randomized participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
122062|NCT00624338|Secondary|Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks|A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in “A”, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.|From screening up to Week 24|MITT population included all the randomized participants who received study treatment.||percentage of participants|||Number
122063|NCT00624338|Secondary|Time to First New Flare as Defined by BILAG Score A or B|"A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in A, mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved."|From screening up to Week 52|MITT population included all the randomized participants who received study treatment||days||95% Confidence Interval|Number
122082|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
122851|NCT00617903|Secondary|Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Scores on a scale||Standard Deviation|Mean
122064|NCT00624338|Primary|Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B|A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in “A”, mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.|From screening up to Week 52|Modified intent-to-treat (MITT) population included all the randomized participants who received study treatment.||percentage of participants|||Number
122065|NCT00624286|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug. FEV1 data taken within 6 h of rescue medication was excluded from this analysis.||Liters||Standard Error|Least Squares Mean
122066|NCT00624286|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Intent-to-treat population: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
122067|NCT00624221|Secondary|Graft Dislocation||1 day to 1 month after grafting||||||
122068|NCT00624221|Secondary|Best Corrected Vision||6 months and 1 year after grafting||||||
122069|NCT00624221|Primary|Endothelial Cell Loss|Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.|6 months after grafting|||percentage of endothelial cell loss||Standard Deviation|Mean
122070|NCT00624195|Primary|Neuropsychological Performance Change|The outcome measure is change in performance from baseline to 16 weeks as measured by the global deficit score (GDS). The GDS is calculated by averaging the individual deficit scores from each neurocognitive test. Deficit scores for each test were calculated from age-, education-, gender-, and ethnicity-adjusted raw scores by methods that capture unexpectedly poor performance while ignoring better than expected performance. The GDS ranges in value from 0-5; higher scores indicate poorer cognitive functioning. Subjects with scores greater than or equal to 0.5 are considered cognitively impaired.|Baseline and 16 weeks|||units on a scale||Standard Deviation|Mean
122071|NCT00624065|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) and Sitting Diastolic Blood Pressure (sDBP) at Week 6|Mean change was calculated as Week 6 values minus Baseline values.|Baseline and Week 6|ITTE||mmHg||Standard Deviation|Mean
122072|NCT00624065|Primary|Number of Participants With Mean Sitting Cuff Blood Pressure <140/90 mmHg at the End of 6 Weeks of Treatment|Sitting cuff blood pressure was calculated as the mean of three measurements taken approximately 2 minutes apart, and before the morning dose.|Week 6|Intent to Treat Efficacy (ITTE) Population: all randomized participants with efficacy (vital signs) data after a minimum of 4 weeks of treatment||Participants|||Number
122073|NCT00624052|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.|up to 34 weeks|91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.||patients|||Number
122074|NCT00624052|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set||mmHg||Standard Deviation|Mean
122075|NCT00624052|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052|up to 34 weeks|Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment||mmHg||Standard Deviation|Mean
122076|NCT00624052|Secondary|Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|up to 34 weeks|Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment||patients|||Number
122077|NCT00624052|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|up to 34 weeks|The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment||Days||Standard Deviation|Mean
122078|NCT00624052|Secondary|Trough BP Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)|||patients|||Number
122083|NCT00624052|Secondary|Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052|The difference between the last available troughs represents the additional reduction in DBP in this study|Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
122084|NCT00624052|Secondary|Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6|Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
122085|NCT00624052|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reached the target SBP of >=140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
122086|NCT00624052|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reached the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||patients|||Number
122087|NCT00623974|Primary|Number of Patients With Success|"A patient success is defined as a normal calcium level (Ca>=8 and Ca<= 10.5) within 48 hours post-treatment initiation and a normal Ca level maintained through day 7 post-treatment initiation."|2 - 7 days post-treatment|Terminated due low accrual, none of 7 participants met eligibility criteria therefore not treated nor randomized to study arms.|||||
122088|NCT00623935|Secondary|Percentage of Participants Alive at 1 Year|One of the secondary objectives was to determine overall survival for patients > 55 years in age with AML undergoing full or reduced transplant with the best available donor.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).||percentage of participants||95% Confidence Interval|Number
122089|NCT00623935|Primary|Percentage of Participants With Relapse Free Survival at 1 Year|The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals > 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.|1 year|56 patients were enrolled. 54 patients were treated (one died prior to transplant, one did not undergo a transplant) and 4 patients were inevaluable (3 patients were less than 1 year post transplant at the time the abstract was written and 1 failed to engraft).||percentage of participants||95% Confidence Interval|Number
122090|NCT00623831|Secondary|Number of Participants With Best Overall Tumor Response|Tumor responses evaluated using computed tomography and categorized according to RECIST version 1.0 at pre-treatment and 4 weeks after the last dose of study treatment. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 3 months|The Tumor Response Analysis Set comprises all subjects who had an end-of-study tumor assessment performed.||participants|||Number
122091|NCT00623831|Secondary|Number of Participants With Serum NY-ESO-1-specific Immune Responses|Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. [Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor]|Up to 3 months|The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.||participants|||Number
122092|NCT00623831|Primary|Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU|Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.|Weeks 1 through 6|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.||participants|||Number
122093|NCT00623831|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment.|Up to 3 months|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.||participants|||Number
122094|NCT00623805|Secondary|Percentage of Participants With a R0 Resection|An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.|Baseline to the end of the study (up to 4 years, 2 months)||||||
122095|NCT00623805|Secondary|Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery||Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Percentage of participants|||Number
122096|NCT00623805|Secondary|Duration of Response|Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)||||||
122097|NCT00623805|Secondary|Time Until a Complete Response or a Partial Response|Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.|Baseline to Month 13|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis.||Months||Standard Deviation|Mean
122098|NCT00623805|Secondary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Percentage of participants|||Number
122099|NCT00623805|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Months||Standard Error|Mean
122100|NCT00623805|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 4 years, 2 months)|Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.||Months||Standard Error|Mean
122101|NCT00623779|Secondary|Ecarin Clotting Time (ECT)|Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)|||sec||Full Range|Median
122102|NCT00623779|Secondary|Activated Partial Thromboplastin Time (APTT)|Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)|||sec||Full Range|Median
122103|NCT00623779|Secondary|Change in D-Dimer Level|Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol.(baseline to week 4 visit)|||ng/ml||Full Range|Median
122104|NCT00623779|Secondary|Plasma Concentration of AR-H067637XX (Active Metabolite)|Assessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit|4 weeks after baseline according to protocol|||nmol/L||Full Range|Median
122105|NCT00623779|Secondary|Plasma Concentration of AZD0837 (Prodrug)|Assessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit|4 weeks after baseline according to protocol|||nmol/L||Full Range|Median
122106|NCT00623779|Secondary|Bilirubin|Number of patients while on study drug with Bilirubin>=2 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3||Participants|||Number
122107|NCT00623779|Secondary|Alanine Aminotransferase (ALAT)|Number of patients while on study drug with Alanine aminotransferase (ALAT)>=3 times upper limit of normal.|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3||Participants|||Number
122108|NCT00623779|Secondary|Change in Creatinine Level|Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)|4 weeks according to protocol (randomisation visit to week 4 visit)|||umol/L||Standard Deviation|Mean
122109|NCT00623779|Secondary|Bleeding Events|Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once|24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)|41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3||Participants|||Number
122110|NCT00623779|Primary|Compliance With Study Visits/Assessments|(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)*100|28 weeks (randomisation visit to last follow up visit) according to protocol|||Percentage||Standard Deviation|Mean
122111|NCT00623779|Primary|Compliance With Study Drug|[(number of doses dispensed-number of doses returned)/number of days between visits]*100|24 weeks (randomisation visit to last treatment visit) according to protocol|||Percentage||Standard Deviation|Mean
122112|NCT00623779|Primary|Premature Discontinuation of Study Due to Any Reason|"|The premature discontinuation of study due to any reason"|28 weeks (randomisation visit to last follow up visit)|||Participants|||Number
122115|NCT00623766|Secondary|Overall Survival (OS)|OS is defined as the time from date of first dose of study drug until the date of death. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those missing a recorded last date of contact will be censored at the last date the patient was known to be alive.|From first dose to 24 months|All participants who received at least 1 dose of ipilimumab||Months||95% Confidence Interval|Median
122116|NCT00623766|Secondary|Onset of Response by Modified World Health Organization (mWHO) Criteria and Immune-related Response Criteria (irRC)|Onset of response is defined as the time between the first dose of study therapy and the date when measurement criteria are first met for global best overall response of partial (PR) or complete (CR), whichever occurs first. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions.|From Day 1, first dose to a maximum of 4.2 months|All participants who received at least 1 dose of ipilimumab. n=number of participants with a best overall response of CR or PR.||Months||Full Range|Median
122117|NCT00623766|Secondary|Number of Participants Who Died or Had a Treatment-related Adverse Event (AE), Immune-related AE, Immune-related Serious Adverse Event (SAE), Nervous System Disorder, Treatment-related Nervous System Disorder, SAE, and AE Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from Day 1, first dose, to 70 days following last dose of ipilimumab|All participants who received at least 1 dose of ipilimumab||Participants|||Number
122118|NCT00623766|Secondary|Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)|OS is defined as the time from the first dose of study drug until the date of death. Overall survival rate is the percentage of participants known to be alive at a timepoint. For those patients who did not die, OS was censored at the recorded last date of patient contact, and those with a missing recorded last date of contact will be censored at the last date the patient was known to be alive. The survival rate at a specified time-point is the probability that a patient is alive at that time following randomization. The rate is calculated for each treatment group using the Kaplan-Meier product-limit method. A corresponding 2-sided 95% bootstrap confidence interval will be calculated.|From first dose to Months 6, 12, 18, 24, and 36 months|All participants who received at least 1 dose of ipilimumab||Probability of being alive||95% Confidence Interval|Number
122119|NCT00623766|Secondary|Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|PFS is defined as the time between the date of the first dose of study therapy and the date of progression or death, whichever occurs first. A patient who dies without reported prior progression will be considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS will be censored on the date of last evaluable tumor assessment. Participants who have not died and have no recorded postbaseline tumor assessment will be censored on the date of first dose of study therapy. Those who die without any recorded postbaseline tumor assessment will be considered to have progressed on the date of death.|From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 months|All participants who received at least 1 dose of ipilimumab||Months||95% Confidence Interval|Median
122120|NCT00623766|Secondary|Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)|DOR is defined in patients whose global best overall response is complete (CR) or partial response (PR) as the time between the date of response of confirmed CR or PR, whichever occurs first, and the date of progressive disease or death, whichever occurs first. For patients who remain alive and have not progressed following response, duration of response will be censored on the date of last evaluable tumor assessment.|From Day 1, first dose to last tumor assessment up to 18.2 months|All participants who received at least 1 dose of ipilimumab||Months||95% Confidence Interval|Median
122121|NCT00623766|Secondary|Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)|BORR is defined as the number of patients whose global best overall response (BOR) was complete (CR) or partial response (PR), divided by the total number of participants who received treatment. CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. The global BOR is the best overall response (OR) designation over the study as a whole for an individual in the study based on overall tumor burden. Both central nervous system (CNS) (brain lesions) and non-CNS compartments (lesions outside the brain) are considered for the global BOR. For the analysis of global BOR of CR or PR (by both modified WHO criteria and immune-related response criteria [irRC]), the OR assessment must be confirmed by a second (confirmatory) evaluation meeting the criteria for response and must be performed no less than 4 weeks after the criteria for response are first met.|From Day 1, first dose until the last tumor assessment, Week 12|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
122122|NCT00623766|Secondary|Disease Control Rate by Immune-related Response Criteria (irRC)|Disease control rate is defined as the number of patients with a best overall response of immune-related (ir) complete response (irCR), partial response (irPR), or stable disease (irSD) divided by the total number of patients who received treatment. By irRC definition: irCR=complete disappearance of all index lesions. irPR=decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index lesions. irSD=does not meet criteria for irCR or irPR, in the absence of ir progressive disease (irPD). irPD=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline). CNS=central nervous system; non-CNS compartment=extracranial, or outside of the brain.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
122370|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Baseline|||units on a scale||Standard Deviation|Mean
122123|NCT00623766|Primary|Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria|Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.|From Day 1, first dose to end of Week 12|All participants who received at least 1 dose of ipilimumab||Percentage of participants||95% Confidence Interval|Number
122124|NCT00623727|Other Pre-specified|Percentage of Participants With Less Than 9 Total Bleeds Per Year in the Open Label Extension Period|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|6 months after start of open label extension period|Participants who completed open label extension period||Percentage of participants|||Number
122125|NCT00623727|Other Pre-specified|Total rFVIII Consumption Per Year|Total number of units per kg of study medication (rFVIII) administered to participant for one year. rFVIII is recombinant factor VIII, factor VIII is functional coagulation factor|up to one year|ITT population||IU per kg||Full Range|Median
122126|NCT00623727|Other Pre-specified|Percentage of Bleeds Treated by Various Numbers of Injections|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP Population||percentage of bleeds|||Number
122127|NCT00623727|Other Pre-specified|Number of Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Number of bleeds 3 weeks after the first infusion per 12 months|up to one year|PP population||bleeds per year||Full Range|Median
122128|NCT00623727|Secondary|Number of Joint Bleeds Per Participant Per Year in Responders|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Responders were the subjects with less than 9 total bleeds per year|up to one year|PP population in responders||Joint bleeds per year||Full Range|Median
122129|NCT00623727|Secondary|Percentage of Participants With Less Than 5 Joint Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|PP population||Percentage of participants|||Number
122130|NCT00623727|Primary|Percentage of Participants With Less Than 9 Total Bleeds Per Year|Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.|up to one year|Per protocol (PP) population||Percentage of participants|||Number
122131|NCT00623714|Secondary|Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated||pg/mL||95% Confidence Interval|Geometric Mean
122132|NCT00623714|Primary|Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)||Baseline and 24 hours post allergen challenge|All Patients as Treated||pg/mL||95% Confidence Interval|Geometric Mean
122133|NCT00623636|Secondary|Number of Subjects With Pain Relief at 10 Minutes|"Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122134|NCT00623636|Secondary|Number of Subjects With Pain Relief at 4 Hours|"Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|4 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122135|NCT00623636|Secondary|Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours|"The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included.~The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from the first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122136|NCT00623636|Secondary|Number of Subjects With Sustained Pain Relief From 2 to 24 Hours|"Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|From 2 to 24 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122137|NCT00623636|Primary|Number of Subjects Nausea Free at 2 Hours From Time of First Dose|"Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122138|NCT00623636|Primary|Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose|"Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122139|NCT00623636|Primary|Number of Subjects Photophobia Free at 2 Hours From Time of First Dose|"Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122140|NCT00623636|Primary|Number of Subjects With Pain Relief at 2 Hours From Time of First Dose|"Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours.~The 4-point scale from the International Headache Society was used:~0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities"|2 hours from time of first dose|mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.||participants|||Number
122141|NCT00623597|Primary|Change In Hematuria, Glycosuria And Proteinuria From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||[0 to 4+]||Standard Deviation|Mean
122142|NCT00623597|Primary|Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||mmol/L||Standard Deviation|Mean
122143|NCT00623597|Primary|Change In Total Bilirubin, Creatinine, Uric Acid From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||umol/L||Standard Deviation|Mean
122144|NCT00623597|Primary|Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||U/L||Standard Deviation|Mean
122145|NCT00623597|Primary|Change In Red Blood Cell (RBC) Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||10*12/L||Standard Deviation|Mean
122146|NCT00623597|Primary|Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||10*9/L||Standard Deviation|Mean
122147|NCT00623597|Primary|Change In Hemoglobin, Total Protein And Total Albumin From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||g/L||Standard Deviation|Mean
122148|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count|Change from baseline in CD8+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD8+ lymphocyte count was derived as follows: Change from baseline = (CD8+ count at week 24/48) – (CD8+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||count/uL||Standard Deviation|Mean
122371|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline|||units on a scale||Standard Deviation|Mean
122149|NCT00623597|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count|Change from Baseline in CD4+ lymphocyte count at 24 weeks and 48 weeks were presented by age group. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week 24/48) – (CD4+ count at baseline). A baseline collection was made if there was not already a value available taken within the previous 4 weeks. Baseline was on Day 1.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 or upon premature discontinuation|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||count/uL||Standard Deviation|Mean
122150|NCT00623597|Secondary|Number of Participants With Virological Failure|Virological failure was defined as: viral load >= 400 copies/mL on two consecutive occasions (missing visits was assumed to be above 400 copies/mL). The number of participants classified as virological failure by Age Group and viral load (≤ 10,000 copies, >10,000 copies) were presented.|From Week 12 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
122151|NCT00623597|Secondary|Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA )|The number of participants experiencing a greater than 1 log drop from baseline (day 1) (log 10 transformed) were reported|From Week 8 till Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
122152|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <50 Copies/mL|The number of participants with HIV-1 RNA results <50 copies/mL were reported.|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
122153|NCT00623597|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) –Ribonucleic Acid (RNA) <400 Copies/mL|The number of participants with HIV-1 RNA results <400 copies/mL were reported|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
122154|NCT00623597|Secondary|Change From Baseline in Mean Human Immunodeficiency Virus Viral Load|Change from baseline in plasma HIV-1 RNA was derived as Change from baseline = Log10 (HIV-1 RNA at week x) – Log10 (HIV-1 RNA at baseline)|Baseline (Day 1), Weeks 8, 12, 24, 36, and 48 (or upon premature discontinuation); a baseline collection was made if there was not already a value available taken within the previous 4 weeks.|The Safety Analysis Population (SAP) comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||log10 copies/mL||Standard Deviation|Mean
122155|NCT00623597|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of ritonasvir was normalized to a dose of 100 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen).|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||h*ug/mL||Standard Deviation|Mean
122156|NCT00623597|Secondary|Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was normalized to a dose of 50 mg/kg for Saquinavir and100 mg/kg for Ritonavir.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an NNRTI containing regimen and at Week 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||ng/mL||Standard Deviation|Mean
122157|NCT00623597|Secondary|Plasma Trough Concentrations (Ctrough) for Ritonavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Ritonavir was normalized to a dose of 100 mg/kg.|Pre-dose at Weeks 8, 12, 24|The PKP population comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||ng/mL||Standard Deviation|Mean
122158|NCT00623597|Primary|Change In Hematocrit From Baseline|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Week 24 and Week 48|The Safety Analysis Population comprised all patients who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||fraction||Standard Deviation|Mean
122159|NCT00623597|Primary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|From Baseline (Day 1) till Week 48 and Follow-up (Week 52)|The Safety Analysis Population (SAP) comprised all participants who received at least one dose of study medication. The SAP was used for all efficacy and safety analyses.||participants|||Number
122384|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
122160|NCT00623597|Primary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir|The area under the plasma concentration-time curve from time zero to twelve hours (AUC0-12h) is area under the plasma concentration-time curve from time zero through actual tlast. The area under the plasma concentration-time curve from time zero to twelve hours of saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose and 3, 4, 8, 12 hours (post-dose) on Day 14 (± 2 days), or Day 28(+ 2 days) for patients switching from an Non-nucleoside reverse transcriptase inhibitor [NNRTI] containing regimen).|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||h*ug/mL||Standard Deviation|Mean
122161|NCT00623597|Primary|Plasma Trough Concentrations (Ctrough) for Saquinavir|Plasma trough concentration is the average steady state concentration prior to morning and evening dose. Ctrough of Saquinavir was normalized to a dose of 50 mg/kg.|Pre-dose at Weeks 8, 12, 24.|The pharmacokinetics Analysis Population (PKP) comprised all the participants from whom blood samples for pharmacokinetic analysis were collected. Participants could be excluded from the PKP if no reliable PK parameters could be determined or if justified by circumstances (e.g. vomiting after drug administration) and in agreement with the sponsor.||ng/mL||Standard Deviation|Mean
122162|NCT00623545|Secondary|Weight Loss After Administration of Exenatide.|Body weight after overnight fast in light clothing|3 months|||kg||Standard Deviation|Mean
122163|NCT00623545|Primary|Change in Energy Intake Measured Before Treatment and at the End of Treatment.|Energy intake is as calculated from energy expenditure as measured by doubly labeled water and change in body energy stores before and at the end of treatment. Units are kcal/d.|3 months|Those that completed baseline and final measurements.||kcal/d||Standard Deviation|Mean
122164|NCT00623506|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability,sleep,weight/appetite change,and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.||units on a scale||Standard Error|Mean
122165|NCT00623506|Secondary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 10) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using LOCF.||units on a scale||Standard Error|Mean
122166|NCT00623506|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|Mean change scores (Week 2 minus Week 10) to assess cognitive changes. The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).|Week 2, Week 10|22 out of 30 patients randomized completed 4 or more weeks of the study and were retained for data analysis. Statistics were completed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Error|Mean
122167|NCT00623480|Other Pre-specified|Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A|The Haemo-QoL-A total score as well as each of its domains have a range between 0 (worst Quality of Life) and 100 (best Quality of Life) points. Therefore, a higher Haemo-QoL-A score denotes greater Quality of Life.|Baseline and 3 years|Full Analysis Set||Scores on a scale||95% Confidence Interval|Least Squares Mean
122168|NCT00623480|Secondary|Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale|The total joint score is derived for each of six joints: left and right sides for knees (score: 0-25), ankles (score: 0-25), and elbows (score: 0-21). Higher CAJAS (Colorado Adult Joint Assessment Scale) score denotes greater joint structure damage thus a positive change from baseline means worsening. CAJAS total score is the sum of all 6 joints, ranging from 0 (best possible outcome) to 142 (worst possible outcome).|Baseline and 3 years|Full Analysis Set||Scores on a scale||95% Confidence Interval|Least Squares Mean
122169|NCT00623480|Secondary|Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.|The Extended MRI Scale total score has a range between 0 (normal unaffected joint) to 45 (maximal joint damage) points. It is composed of 2 domains, the soft tissue domain with a maximum of 9 points and the osteochondral domain with a maximum of 36 points. A single score for each subject was to be calculated from the sum of both domains and the average over all joints for the Extended MRI endpoint. Higher MRI score denotes greater joint structure damage thus a positive change from baseline means worsening.|Baseline and 3 years|Full Analysis Set||Scores on a scale||95% Confidence Interval|Least Squares Mean
122170|NCT00623480|Primary|Bleeding Frequency (Number of Total Bleeds)||After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days)|ITT (Intent-to-treat) Population||Bleeds||Full Range|Median
122171|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|FAS||scores on a scale||Standard Deviation|Mean
122172|NCT00623467|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|FAS||scores on a scale||Standard Deviation|Mean
122173|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122174|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122175|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122176|NCT00623467|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122177|NCT00623467|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122178|NCT00623467|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122179|NCT00623467|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122180|NCT00623467|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122208|NCT00623428|Secondary|Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation|"Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.~Participants without Week 72 measurements were considered non-responders in the analysis."|Week 72|All randomized patients.||percentage of participants|||Number
122181|NCT00623467|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||percentage of participants|||Number
122182|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
122183|NCT00623467|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images was the percentage of the exact matches with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||per. of the exact diagnostic matches|||Number
122184|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122185|NCT00623467|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122186|NCT00623467|Secondary|Scores for Contrast Enhancement for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. The data for contrast enhancement - gadobutrol combined was shown below.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122187|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122188|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122189|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
126953|NCT00578812|Secondary|Mean SF-36 Physical Component Summary (PCS)|Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol||units on a scale||Standard Deviation|Mean
122190|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122191|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122192|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122193|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122194|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122195|NCT00623467|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS||lesions||Standard Deviation|Mean
122196|NCT00623467|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|"The clinical investigators evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible. The data for contrast enhancement - unenhanced were not collected for the clinical investigators."|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122197|NCT00623467|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The 3 blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|FAS||lesions||Standard Deviation|Mean
122198|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122306|NCT00622440|Secondary|Treatment Adherence|"Percent of recommended applications of cream reported in participant diary.~>75% = Excellent >50%-75% = Good >25%-50% = Poor <25% = Non-adherent"|48 weeks|Excludes 7 AIJP participants and 6 Placebo participants who dropped out before week 48. Excludes 1 Placebo participant deemed non-evaluable.||participants|||Number
122199|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122200|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.||scores on a scale||Standard Deviation|Mean
122201|NCT00623467|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 (reader 1 of 3) evaluated the images from the unenhanced magnetic resonance imaging (MRI) in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI and combined unenhanced and gadobutrol-enhanced MRI, excluding the sample participants (the first participant from each study site).||scores on a scale||Standard Deviation|Mean
122202|NCT00623441|Primary|MACE (Major Adverse Cardiac Events)|MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))|12 Months|Intention to Treat (ITT)||Percentage of participants|||Number
122203|NCT00623428|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as incapacitating with inability to work or perform normal daily activity. A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above."|From Week 1 through Week 72.|||participants|||Number
122204|NCT00623428|Secondary|Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.|12 weeks after actual end of treatment (range from Week 36 to Week 60)|All randomized patients.||percentage of participants|||Number
122205|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment|Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.|24 weeks after actual end of treatment (range from Week 48 to Week 72).|All randomized patients.||percentage of participants|||Number
122206|NCT00623428|Secondary|Percentage of Participants With Virological Relapse|"Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.~Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.~Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end."|End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).|Randomized patients with virological response at the end of treatment and at least one post-treatment HCV RNA measurement.||percentage of participants|||Number
122207|NCT00623428|Secondary|Percentage of Participants With Virological Response at End of Treatment|Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.|End of Treatment (Week 24 and Week 48 for each treatment group respectively).|All randomized patients. A backward imputation approach was used when the HCV RNA measurement at end of treatment was missing and HCV RNA was <15 IU/mL at the first measurement after the end of treatment time window (the patient was regarded as having virological response at end of treatment).||percentage of participants|||Number
122209|NCT00623428|Primary|Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment|"Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.~Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis."|24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.|All randomized patients.||percentage of participants|||Number
122210|NCT00623233|Secondary|1-Year Overall Survival (OS) Rate|OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data.|Baseline to death from any cause, 1 year|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=25; censored participants=27.||percentage of participants||95% Confidence Interval|Number
122211|NCT00623233|Secondary|Number of Participants With Adverse Events (AEs); Pharmacology Toxicities|A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.|Baseline, every cycle (every 14 days) up to 34 months|The safety population was the treated population and included all participants who received at least 1 dose of study therapy.||participants|||Number
122212|NCT00623233|Secondary|Overall Tumor Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population).|Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).|The per protocol (PP) population included all intent-to-treat (ITT) participants who met the following criteria: histological or cytological diagnosis of breast cancer; presence of measurable disease at baseline per RECIST criteria; had at least 1 dose of study drug; no current systemic anti-tumor treatment other than protocol-specified therapy.||proportion of responders||95% Confidence Interval|Number
122213|NCT00623233|Primary|Progression Free Survival (PFS) Time|PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.|Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).|The intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug. Participants with events=41; censored participants=11.||months||95% Confidence Interval|Median
122214|NCT00623194|Secondary|Vital Signs: Pulse|Pulse at week 104|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||beats/minute||Standard Deviation|Mean
122215|NCT00623194|Secondary|Vital Signs: Blood Pressure|Blood pressure (Systolic and Diastolic) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||mmHg||Standard Deviation|Mean
122216|NCT00623194|Secondary|Fundoscopy/Fundus Photography|"Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant~Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant"|at 52 weeks and at 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||participants|||Number
122217|NCT00623194|Secondary|Laboratory Values: Leukocytes and Thrombocytes|Leukocytes and Thrombocytes after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||10^9/L||Standard Deviation|Mean
122218|NCT00623194|Secondary|Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)|Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||U/L||Standard Deviation|Mean
122219|NCT00623194|Secondary|Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)|Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||mmol/L||Standard Deviation|Mean
122220|NCT00623194|Secondary|Laboratory Values: Creatine Serum Umol/L|Creatine serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||Umol/L||Standard Deviation|Mean
122221|NCT00623194|Secondary|Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)|Albumin Serum and Total Protein Serum after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||g/dL||Standard Deviation|Mean
122222|NCT00623194|Secondary|Insulin Dose|Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||U/kg||Standard Deviation|Mean
122223|NCT00623194|Secondary|Diabetic Ketoacidosis|Diabetic ketoacidosis requiring hospitalisation|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||events|||Number
122333|NCT00622284|Secondary|Change in Baseline Lipid Parameter Triglyceride at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dL||Standard Deviation|Mean
122224|NCT00623194|Secondary|SD-score (Z-score) for Body Weight|Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||SD-scores||Standard Deviation|Mean
122225|NCT00623194|Secondary|BMI (Body Mass Index)|BMI (Body Mass Index) after 104 weeks.|At 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||kg/m^2||Standard Deviation|Mean
122226|NCT00623194|Secondary|Hypoglycaemic Episodes|"Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.~Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment."|Weeks 0-104|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension.||events|||Number
122227|NCT00623194|Secondary|Fasting Plasma Glucose Values|FPG (Fasting Plasma Glucose) values after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.||mmol/L||Standard Deviation|Mean
122228|NCT00623194|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.|At 104 weeks|Full analysis set 146 (100%) The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
122229|NCT00623194|Secondary|Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies|Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.|At 0, 52 and 104 weeks|The safety analysis set included all subjects with a signed informed consent who were exposed in the extension period.||Percent bound of total||Standard Error|Mean
122230|NCT00623194|Primary|Insulin Detemir-insulin Aspart Cross-reacting Antibodies|Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.|week 0, 52 and 104|"Full analysis set 146 (100%), safety analysis set 146 (100%)~The full analysis set was used for efficacy analyses and included subjects with signed informed consent who had been exposed to trial drug in extension.~The safety analysis set included all subjects with a signed informed consent who were exposed in the extension."||Percent bound of total||Standard Error|Mean
122231|NCT00623181|Other Pre-specified|Number of Participants Reporting Solicited Systemic Reactions After Vaccine Injection|"Solicited systemic reactions: Fever (temperature); Headache; Malaise; and Myalgia.~Data for this outcome were based on the first vaccination type, intradermal or intramuscular."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated subjects, intend-to-treat population.||Participants|||Number
122232|NCT00623181|Other Pre-specified|Number of Participants Reporting Any Solicited Injection Site Reactions After Vaccine Injection|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, Ecchymosis.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0 through 7 post-vaccination|Safety parameters were assessed in all enrolled and vaccinated participants, intend-to-treat population.||Participants|||Number
122233|NCT00623181|Primary|Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Numerical scores were assigned to pain by participants on the preference questionnaire as: None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; or Unbearable = 9, 10.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Days 0, 3, and 7 after vaccination|||Scores on a scale||Standard Deviation|Mean
122234|NCT00623181|Primary|Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination|"Pain or other discomfort was assessed on a scale of 0 to 10 (None = 0; Hardly Any = 1, 2; Mild = 3, 4; Moderate = 5, 6; Severe = 7, 8; Unbearable = 9, 10) according to route of administration: intradermal (ID) as Group 1 and intramuscular (IM) as Group 2.~Data for this outcome were combined for responses following a similar type of vaccination route in the entire study population."|Day 0 and up to 7 days post-vaccination|Pain or other discomfort was assessed in the Per-Protocol Population. Data were combined for responses following a similar type of vaccination route.||Participants|||Number
122235|NCT00623103|Secondary|UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).|From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)|The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints.||Score||Standard Deviation|Mean
122236|NCT00623103|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|"The 23 item caregiver-based ADL scale of the dementia Alzheimer’s disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items.~The change from baseline was calculated such that a positive change indicates an improvement."|From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF).||Score||Standard Deviation|Mean
122237|NCT00623103|Secondary|Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).|At Week 16, 24, 52 and 76 (or early discontinuation)|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)||Score||Standard Deviation|Mean
122238|NCT00623103|Secondary|Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)||Score on a scale||Standard Deviation|Mean
122239|NCT00623103|Secondary|Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline|Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention [0-37], Initiation/Perservation [0-37] (performing alternating movements), Construction [0-6] (copying designs), Conceptualization [0-39] (similarities) and Memory [0-25] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.|From Baseline to Weeks 16, 24, 52 and 76|Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)||Score on a scale||Standard Deviation|Mean
122240|NCT00623103|Secondary|Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline|Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.|From Baseline to Weeks 8, 16, 24, 52 and 76|"Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. n in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements."||Score on a scale||Standard Deviation|Mean
122241|NCT00623103|Primary|Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
122242|NCT00623103|Primary|Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)|The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.|76 Weeks|Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.||Percentage of participants||95% Confidence Interval|Number
122243|NCT00623012|Secondary|Disease Free Survival|achieved disease free in regard to leukemia|up to 10 weeks|||participants|||Number
122244|NCT00623012|Secondary|Overall Survival|achieved overall survival in regard to leukemia|up to 10 weeks|||participants|||Number
122245|NCT00623012|Primary|Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.|Percentage of patients free from graft versus host disease|up to 8 weeks|||percentage of patients|||Number
122246|NCT00622908|Secondary|Eradication of Baseline Pathogens Day 4 (+/- 1 Day)|Bacterial species eradication of baseline bacterial infection|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
122247|NCT00622908|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)|The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 2 - Day 4 (+/- 1 day)|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
122248|NCT00622908|Primary|Eradication of Baseline Pathogens (Day 8 or 9)|Bacterial species eradication of baseline bacterial infection|Visit 3 - Day 8 or day 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
122249|NCT00622908|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)|Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.|Visit 3 - day 8 or 9|Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.||Participants|||Number
122334|NCT00622284|Secondary|Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dL||Standard Deviation|Mean
122250|NCT00622869|Secondary|Change in Renal Function From Randomization to Months 12 and 24|"Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.~The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported."|Randomization to Month 24|Intent-to-treat population: All randomized patients.||mL/min/1.73m^2||Standard Error|Least Squares Mean
122251|NCT00622869|Secondary|Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24|"tBPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3, which was treated with anti-rejection therapy. Liver biopsies were collected for all cases of suspected acute rejection preferably within 24 hours, at the latest within 48 hours, whenever clinically possible. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.~The incidence rates of tBPAR were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.||Percentage|||Number
122252|NCT00622869|Secondary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 24|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death.~The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 24|Intent-to-treat population: All randomized patients.||Percentage|||Number
122253|NCT00622869|Primary|Incidence Rate of Composite Efficacy Failure From Randomization to Month 12|"Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.~The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula."|Randomization to Month 12|Intent-to-treat population: All randomized patients.||Percentage of participants|||Number
122254|NCT00622739|Secondary|Children's Depression Rating Scale||Weekly||||||
122255|NCT00622739|Secondary|AIMS (Abnormal Involuntary Movement Scale)||Weekly||||||
122256|NCT00622739|Secondary|SAFTEE (Side Effects Rating Scale)||Weekly||||||
122257|NCT00622739|Secondary|Clinical Global Impressions (CGI) Scale||Weekly||||||
122258|NCT00622739|Primary|Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.|6 weeks of treatment|||units on a scale||Standard Error|Least Squares Mean
122259|NCT00622726|Secondary|Visual Acuity|The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.|Age 7 years.||||||
122260|NCT00622726|Secondary|Myopia in Zone I and Posterior Zone II of Infant Eyes|Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.|2.5 years of age|As of 6/2013, there were 13 deaths/ 26 eyes. Exclusions from surviving 137 infants/ 274 eyes: 6 infants/19 eyes with intraocular surgery--leaving: 131 infants/ 255 eyes; 14 infants/ 21 eyes had recurrence and 22 infants/ 44 eyes were lost to follow-up--leaving: 95 infants/ 190 eyes. Thus, only the refractions on these infants/ eyes are given.||Diopters|Participants|Standard Deviation|Mean
122261|NCT00622726|Primary|Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment|"For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization.~For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation)."|54 weeks postmenstrual age (window of 50 to 70 weeks)|Both eyes of all surviving infants were analyzed for recurrence: thus, 143 surviving infants and 286 eyes were analyzed. Reporting the number of eyes that developed recurrences||eyes with recurrences|Participants||Number
122262|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||Scores on a scale||Standard Deviation|Mean
122263|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||scores on a scale||Standard Deviation|Mean
122264|NCT00622713|Secondary|Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score|The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening.|Baseline to week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||scores on a scale||Standard Deviation|Mean
122265|NCT00622713|Secondary|Clinical Global Impression of Change (CGI-C) by Physician|"The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:very much improved, much improved, slightly improved, unchanged, slightly worsened, much worsened and very much worsened."|Baseline and week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. Last observation carried forward (LOCF) was used for missing values.||Percentage of participants|||Number
122266|NCT00622713|Primary|Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study|The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2.|24 weeks|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||Percentage of participants|||Number
122267|NCT00622700|Other Pre-specified|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);~Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin (TB) >1.5, 2, or 3 ULN;~ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population as described in Outcome Measure 13. Here 'n' signifies the number of participants for the treatment group who had that parameter assessed at post-baseline.||participants|||Number
122268|NCT00622700|Secondary|Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first|Safety population: all randomized participants exposed to study medication; analyzed according to drug actually received. In Placebo arm 4 received teriflunomide 7 mg and 2 received teriflunomide 14 mg, hence were included in respective teriflunomide arm. Participants who were randomized but not treated were excluded (2 in each teriflunomide arm).||participants|||Number
122269|NCT00622700|Secondary|Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||units on a scale||Standard Error|Least Squares Mean
122270|NCT00622700|Secondary|Change From Baseline in EDSS at Week 108|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||units on a scale||Standard Error|Least Squares Mean
122271|NCT00622700|Secondary|Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.||percent probability||95% Confidence Interval|Number
122272|NCT00622700|Secondary|Brain MRI Assessment: Percent Change From Baseline in Atrophy|Atrophy was measured by MRI scan.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||percent change||Standard Deviation|Mean
122273|NCT00622700|Secondary|Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component|Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
122274|NCT00622700|Secondary|Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component|Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
122275|NCT00622700|Secondary|Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.||milliliters per scan|||Number
122276|NCT00622700|Secondary|Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population, but including only participants who had post-baseline data.||lesions per scan||95% Confidence Interval|Number
122277|NCT00622700|Secondary|Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 108|ITT population, but including only participants who had post-baseline data.||milliliter||Standard Error|Least Squares Mean
122278|NCT00622700|Secondary|Annualized Relapse Rate (ARR)|ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.||relapses per patient year||95% Confidence Interval|Number
122279|NCT00622700|Secondary|Time to Conversion to Definite Multiple Sclerosis (DMS)|Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population.||percent probability||95% Confidence Interval|Number
122280|NCT00622700|Primary|Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS)|Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population included all randomized participants who had at least 1 day study medication exposure. Participants were analyzed in the treatment group to which they were randomized||percent probability||95% Confidence Interval|Number
122281|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122282|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 23 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|23 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122283|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 22 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|22 hours post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
126954|NCT00578812|Secondary|Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)|Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
122284|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 45 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122285|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 20 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|20 hours 10 minutes post-dose at the end of each treatment period (Day 15)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122286|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 14 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|14 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122287|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 45 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 45 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122288|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 11 Hours 10 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|11 hours 10 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122289|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 10 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|10 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122290|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 8 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|8 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122291|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 6 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|6 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122292|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122293|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 4 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|4 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122294|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 3 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|3 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122335|NCT00622284|Secondary|Change in Baseline Lipid Parameter HDL at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dl||Standard Deviation|Mean
122336|NCT00622284|Secondary|Change in Baseline Lipid Parameter Cholesterol at Week 104||Baseline and week 104|This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.||mg/dL||Standard Deviation|Mean
122295|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|2 hours post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122296|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|1 hour post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122297|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|30 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122298|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|15 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122299|NCT00622635|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|5 minutes post-dose at the end of each treatment period (Day 14)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122300|NCT00622635|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.|After 14 days|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
122301|NCT00622518|Secondary|Side Effects of Therapy||5 days|Specific side effects were collected on patients whose parents returned study diaries (44 from ear drop group and 50 from standard care only group). In addition, parents were telephoned and asked about any serious side effects.||participants|||Number
122302|NCT00622518|Primary|Resolution of Otitis Media Symptoms|Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.|5 days|Data were analyzed on participants from whom data diaries were returned and who had data for an assessment. Data were analyzed on the following number of children at each assessment: 1- 50 standard care (SC),40 ear drop (ED) 2- 40SC 35ED 3- 49SC 37ED 4- 40SC 36ED 5- 44SC 35ED 6- 42SC 34ED 7- 44SC 34ED 8- 43SC 31ED 9- 44SC 33ED 10- 44SC 29ED||units on a scale||Standard Deviation|Mean
122303|NCT00622440|Secondary|Response With >75% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree that HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)~No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, 48 weeks, 60 weeks|Evaluable participants who finished 48 weeks of treatement and reported >75% adherence to treatment||participants|||Number
122304|NCT00622440|Secondary|Response With >50% Adherence|"Response assessed 12 weeks after treatment (week 60), by treatment adherence assessed at 48 weeks.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60; two independent reviews agree HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs reviewed by two clinicians, with decision by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in number of lesions with HSIL, or improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes improved)~No Response (NR): HSIL present on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline, 48 weeks, 60 weeks|Evaluable participants who finished 48 weeks of treatement and reported >50% adherence to treatment||participants|||Number
122305|NCT00622440|Secondary|Estimate Effect Size for Phase 3 Trial|Secondary outcome stated in original protocol posting|Baseline, Week 60||07/2015||||
122307|NCT00622440|Primary|Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL)|"Response assessed 12 weeks after treatment.~Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60.~Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences)~Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved)~No Response (NR): HSIL present at weeks 48 & 60 on histology, or improvement ≤ 50% in number, size, area or characteristics."|Baseline/screen, Week 48, Week 60|||participants|||Number
122308|NCT00622427|Secondary|Change in Clinical Global Impression (CGI)|The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). The outcome measure is the percent difference between the total score for all subjects at day 1 and the total score for all subjects at day 14 of the study drug.|day 1 to day 14 of study drug|||percentage of change||Standard Deviation|Mean
122309|NCT00622427|Primary|Change in Baseline to 2 Weeks ADHD Rating Scale|It is an 18 item scale with 9 symptoms of inattention and 9 symptoms of Impulsivity and Hyperactivity. This scale is the gold standard in assessment of ADHD. Scores range from 0-54. There must be a score of 6 or more in either category to be diagnosed with ADHD. Severity ranges: 6-18 mild, 19-36 moderate, 37-54 severe. The outcome measure is the percentage difference between the total day 1 score for all subjects and the total 14 day score for all subjects.|day 1 to day 14 of study drug|||percentage of change||Standard Deviation|Mean
122310|NCT00622401|Primary|Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine|Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.|3 years|All three patients experienced adverse events that were determined to be at least possibly related to the vaccine. The number of times each toxicity was observed is captured in the adverse events section.||participants|||Number
122311|NCT00622401|Secondary|To Determine if Vaccination With DC/Tumor Fusions and rhIL-12 Results in Clinically Measurable Disease Responses.|This outcome was not measured because no patients were treated with rhIL-12.|3 years||||||
122312|NCT00622401|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.|This outcome was not measured because no patients were treated with rhIL-12.|3 years||||||
122313|NCT00622388|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; up to 11 months after the last dose)|FAS. Data are presented for the number of participants attending each visit for whom the parameter can be calculated.||liters||Geometric Coefficient of Variation|Geometric Mean
122314|NCT00622388|Secondary|Clearance (CL) of Ofatumumab at the Eighth Infusion|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are presented for the number of participants at each visit for whom the parameter can be calculated.||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
122315|NCT00622388|Secondary|Half-life (T1/2) for Ofatumumab at the Eighth Infusion|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants at each visit for whom the parameter could be calculated.||hours||Geometric Coefficient of Variation|Geometric Mean
122316|NCT00622388|Secondary|Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.|Visit 2 (Week 0) and Visit 9 (Week 7)|FAS. Data are provided for the number of participants attending each visit.||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
122317|NCT00622388|Secondary|AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 11 months after last dose)|FAS. Data are provided for the number of participants attending each visit for whom the parameter value could be calculated. Participants contributing AUC(0-inf) data also contributed AUC(0-168) data.||micrograms*hour/milliliter (µg.h/mL)||Geometric Coefficient of Variation|Geometric Mean
122318|NCT00622388|Secondary|Percent Change From Screening in Complement (CH50) Levels|CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.|Screening and post-baseline visits (last visit was to occur 24 months post first dose)|FAS|||||
122319|NCT00622388|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).|Time frame is from date of start of treatment to 2 years or withdrawal|FAS||participants|||Number
122320|NCT00622388|Secondary|Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits|B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.|Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)|FAS. Data are provided for the number of participants attending each visit.||percent change in cells||Full Range|Median
122321|NCT00622388|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18|HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.|Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)|FAS. Data are provided for the number of participants attending each visit.||participants|||Number
122322|NCT00622388|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.|From date of start of treatment to 5 years or withdrawal|FAS|||||
122323|NCT00622388|Secondary|Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy|Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 5 years or withdrawal|FAS||months||95% Confidence Interval|Median
122324|NCT00622388|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from treatment start until progression or death.|From date of start of treatment to 2 years or withdrawal|FAS||months||95% Confidence Interval|Median
122325|NCT00622388|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed.|From date of start of treatment to 2 years or withdrawal|FAS. Only participants with CR or PR were analyzed.||months||95% Confidence Interval|Median
122326|NCT00622388|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response|"According to the revised response criteria for malignant lymphoma, responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD."|6-month period from start of treatment (up to Week 24)|FAS||participants|||Number
122327|NCT00622388|Primary|Number of Participants With Objective Response|Objective response of ofatumumab treatment was assessed according to the “revised response criteria for malignant lymphoma.” Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.|6-month period from start of treatment (up to Week 24)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment||participants|||Number
122328|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Extension Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.|Included participants who were enrolled in the extension phase. The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.||participants|||Number
122329|NCT00622336|Secondary|Duration of Response|Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998 and defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on International Myeloma Working Group (IMWG) criteria.|Up to 70 months|Duration of response not analyzed per the sponsors decision.|||||
122330|NCT00622336|Secondary|Myeloma Response Rate|Myeloma response determination criteria developed by Bladé et al 1998. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to 70 months|Myeloma Response Rate not analyzed per the sponsors decision.|||||
122331|NCT00622336|Secondary|Time to Progression|Time to progression based on the myeloma response determination criteria developed by Bladé et al 1998 and is defined as the time from registration to the first documented progression.|Up to 70 months|Time to progression not analyzed per the sponsors decision.|||||
122332|NCT00622336|Primary|Number of Participants With Adverse Events (AE) During the Treatment Phase|An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.|The safety population included participants enrolled in the study and had received at least one dose of lenalidomide.||participants|||Number
122337|NCT00622284|Secondary|HbA1c Change at Week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122338|NCT00622284|Secondary|HbA1c Change at Week 91||Baseline and week 91|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122339|NCT00622284|Secondary|HbA1c Change at Week 78||Baseline and week 78|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122340|NCT00622284|Secondary|HbA1c Change at Week 65||Baseline and week 65|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122341|NCT00622284|Secondary|HbA1c Change at Week 52||Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122342|NCT00622284|Secondary|HbA1c Change at Week 40||Baseline and week 40|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122343|NCT00622284|Secondary|HbA1c Change at Week 28||Baseline and week 28|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122344|NCT00622284|Secondary|HbA1c Change at Week 16||Baseline and week 16|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122345|NCT00622284|Secondary|HbA1c Change at Week 12||Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122346|NCT00622284|Secondary|HbA1c Change at Week 8||Baseline and week 8|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122347|NCT00622284|Secondary|HbA1c Change at Week 4|Difference of base percent value [Week x(%) - baseline (%)]|Baseline and week 4|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Deviation|Mean
122348|NCT00622284|Secondary|2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.|Baseline and week 104|Patients in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104).||mg/dL||Standard Error|Mean
122349|NCT00622284|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 104|Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104|Week 104|FAS (NCF)||Percentage of patients|||Number
122350|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 104|The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.||Percentage of patients|||Number
122351|NCT00622284|Secondary|Percentage of Patients With HbA1c <6.5% at Week 52|The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.||Percentage of patients|||Number
122352|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 104|The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 104|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.||Percentage of patients|||Number
122353|NCT00622284|Secondary|Percentage of Patients With HbA1c <7.0% at Week 52|The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.|Week 52|Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.||Percentage of patients|||Number
122354|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 104|This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.||mg/dL||Standard Error|Mean
122355|NCT00622284|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 52|This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.||mg/dL||Standard Error|Mean
122356|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 104 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)|Week 104|The treated set consisted of all patients treated with at least one dose of study drug||Patients|||Number
122357|NCT00622284|Secondary|Incidence of Hypoglycaemic Events up to 52 Weeks|A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)|Week 52|The treated set consisted of all patients treated with at least one dose of study drug||Patients|||Number
122358|NCT00622284|Secondary|Body Weight Change From Baseline at Week 104|This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 104|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.||kg||Standard Error|Mean
122359|NCT00622284|Secondary|Body Weight Change From Baseline at Week 52|This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.|Baseline and week 52|This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.||kg||Standard Error|Mean
122360|NCT00622284|Primary|HbA1c Change From Baseline at Week 104|This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 104|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Error|Mean
122361|NCT00622284|Primary|HbA1c Change From Baseline at Week 52|This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.|Baseline and week 52|The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.||Percent||Standard Error|Mean
122362|NCT00622167|Primary|Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).|At time of imaging|Imaging 30 subjects was predicted to include enough plaques for analysis.||plaques|Participants||Number
122363|NCT00621985|Primary|Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens|Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.|23 hours|Only four participants completed both the hydrocortisone and dexamethasone admissions.||Log Mean Area Under the Curve||Standard Deviation|Log Mean
122364|NCT00621959|Secondary|Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score|The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6.|Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)|Number of participants from the Intent-To-Treat (ITT) population with available overall RQLQ score at Endpoint visit and at Baseline||points on a scale||Standard Deviation|Mean
122365|NCT00621959|Primary|Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)|Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15.|Over the total treatment period (14 days)|Number of participants from the Intent-To-Treat (ITT) population with available T5SS over the Total Treatment Period||points on a scale||Standard Deviation|Mean
122366|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
122367|NCT00621946|Primary|ACQ (Asthma Control Questionnaire)|The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
122368|NCT00621946|Primary|HAM-D (Hamilton Rating Scale for Depression)|The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).|Up to 12 weeks|||units on a scale||Standard Deviation|Mean
122369|NCT00621946|Primary|IDS-SR (Inventory of Depressive Symptomatology - Self-Report)|The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).|Baseline|||units on a scale||Standard Deviation|Mean
122852|NCT00617903|Secondary|Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
122372|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
122373|NCT00621933|Secondary|Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
122374|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
122375|NCT00621933|Primary|Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid|Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).|Baseline|ITT population. All patients with cultures performed of the ocular surface.||Percentage of Species|||Number
122376|NCT00621855|Secondary|Laboratory Analyses|Number of patients with possible clinically significant abnormalities. Clinically significant abnormalities refers to the increase or decrease from baseline.|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
122377|NCT00621855|Secondary|Number of Participants With Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds (CRBE) and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
122378|NCT00621855|Secondary|Change From Baseline in log10 D-dimer After 1 and 4 Weeks|Change from baseline in log10 D-dimer concentration after 1 and 4 weeks of dabigatran etexilate treatment compared to placebo. The standard deviation is the geometric standard deviation.|Baseline and at 1 week and 4 weeks|Full Analysis Set (FAS)||ratio||Standard Deviation|Geometric Mean
122379|NCT00621855|Secondary|Number of Participants With Any Reduction of D-dimer Concentration||at 1 week and 4 weeks|Full analysis set - The full analysis set includes all randomised and treated patients who had at least one post-dose assessment of D-dimer available.||participants|||Number
122380|NCT00621855|Secondary|Individual Occurrence of Death (Cardiovascular and All-cause), Non-fatal MI, Severe Recurrent Ischaemia and Non-haemorrhagic Stroke During Six Months of Treatment|Number of Participants with individual occurrence of death (cardiovascular and all-cause), non-fatal MI, severe recurrent ischaemia and non-haemorrhagic stroke during six months of treatment.|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
122381|NCT00621855|Secondary|Composite of Cardiovascular Death (CVD) With Non Fatal Myocardial Infarction (MI) and Non Haemorrhagic Stroke and All Cause Death (ACD), Non Fatal MI, Severe Recurrent Ischaemia (SRI) and Non Haemorrhagic Stroke During Six Months Treatment|Number of Participants with Composite of Cardiovascular death (CVD) with non fatal myocardial infarction (MI) and non haemorrhagic stroke and All cause death (ACD), non fatal MI, severe recurrent ischaemia (SRI) and non haemorrhagic stroke during six months treatment|6 month treatment period + 2 week post treatment follow up|Treated set||participants|||Number
122382|NCT00621855|Primary|Number of Participants Displaying the Composite of Major and Clinically Relevant Minor Bleeding Events During Total Observation Time|"International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed.~A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells.~All non major bleeding events were classified as minor bleeds; minor bleeds were subdivided in clinically relevant minor bleeds and not clinically relevant minor bleeds. A CRBE was defined as an acute or subacute clinically overt bleed that did not meet the criteria of a major bleed but either lead to hospital admission and/or a physician guided medical or surgical treatment and/or a change in antithrombotic therapy (including interruption or discontinuation of study drug)."|6 month treatment period + 2 week post treatment follow up|Treated set - The treated set includes all patients who received at least one dose of study medication.||participants|||Number
122383|NCT00621842|Secondary|Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
122385|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)|The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
122386|NCT00621842|Secondary|Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
122387|NCT00621842|Secondary|Number of Participants Who Fell at Least Once During the Study||12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
122388|NCT00621842|Secondary|Change in Body Weight From Baseline||12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||lbs.||95% Confidence Interval|Mean
122389|NCT00621842|Secondary|Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)|The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
122390|NCT00621842|Secondary|Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
122391|NCT00621842|Secondary|Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
122392|NCT00621842|Secondary|Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)|The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
122393|NCT00621842|Secondary|Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)|Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.|12 weeks|The number of participants was chosen from the number who received at least one dose of lamotrigine.||participants|||Number
122394|NCT00621842|Primary|Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|12 weeks|The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.||units on a scale||95% Confidence Interval|Mean
122395|NCT00621777|Secondary|Effect of Treatment With Varenicline Versus Placebo on Health-related Quality of Life Indices in Recently Abstinent Smokers With Schizophrenia or Bipolar Disorder||53 weeks||||||
122396|NCT00621777|Secondary|Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking||53 weeks||||||
122397|NCT00621777|Primary|Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group||76 weeks|||participants|||Number
122398|NCT00621764|Other Pre-specified|Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Geometric Mean Titers Against JE Antibodies were assessed in the Full Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
122399|NCT00621764|Other Pre-specified|Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination|Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) up to 5 years after final vaccination|Persistence of seroprotection to JE-CV antigens was assessed in the Full Analysis Set.||Participants|||Number
122400|NCT00621764|Secondary|Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers against the JE-CV vaccine antigens were assessed in the Per-Protocol Analysis Set.||Titers||95% Confidence Interval|Geometric Mean
126955|NCT00578812|Secondary|Mean Neck Disability Index (NDI)|Mean NDI at 24 months on a 0-100 scale (lower value is better).|24 Months|Per protocol||units on a scale||Standard Deviation|Mean
122401|NCT00621764|Secondary|Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination|JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion to the JE-CV vaccine antigens was assessed in the Per-Protocol Analysis Set.||Percentage of participants|||Number
122402|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.~2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine. A participant in Group 1 was given JE-CV vaccine as the second vaccination in error; and counted for Group 2 for the safety outcome for the second injection.||Participants|||Number
122403|NCT00621764|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection|"12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.~2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities."|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.||Participants|||Number
122404|NCT00621686|Secondary|Overall Survival|Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.|Time from date of registration to a) date of death due to any cause or b) last follow-up; Up to 15 years|||months||95% Confidence Interval|Median
122405|NCT00621686|Secondary|Time to Progression|Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test.|Time from study registration to a) date of disease progression, or b) last follow-up; Up to 15 years|||months||95% Confidence Interval|Median
122406|NCT00621686|Primary|6-month Progression-free Survival|Primary Endpoint: 6-month progression free survival (PFS6): The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. To be classified as a success, an evaluable patient must be alive and progression-free 6 months after registration to the study. Patients who die prior to 6 months after study registration will be considered to have failed.|at 6 months|||proportion of participants||95% Confidence Interval|Number
122407|NCT00621621|Secondary|AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.||After 250 subjects have been enrolled.|||participants||95% Confidence Interval|Number
122408|NCT00621621|Primary|Device or Procedure Related AV Block Persistent Through Discharge From Hospital.||After 250 subjects have been enrolled.|||participants||95% Confidence Interval|Number
122409|NCT00621582|Secondary|Physician Tolerability Assessment at Visit 3|The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)|8 weeks (Visit 3)|Full Analysis Set (FAS)||Participants|||Number
122410|NCT00621582|Primary|Patient Tolerability Assessment at Visit 3|"Patient tolerability assessment classified as Unsatisfied, Satisfied, Good and Very Good"|8 weeks (Visit 3)|Full Analysis Set (FAS)||Participants|||Number
122411|NCT00621582|Secondary|Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8;~Represents number of participants who score good and excellent at visit 2 (2 weeks) and visit 3 (8 weeks)"|2 weeks (Visit 2 and 8 weeks (Visit 3)|||Participants|||Number
122412|NCT00621582|Primary|Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)|"The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least).~Represents number of participants who score good and excellent at visit 1 (0 weeks) and visit 3 (8 weeks)"|0 weeks (Visit 1) and 8 weeks (Visit 3)|Sampling Method: Non-Probability Sample; conducted in primary care clinics.||Participants|||Number
122413|NCT00621543|Secondary|Percentage of Women Continuing IUD Use at 3 Months||3 months|||percentage of participants||95% Confidence Interval|Mean
122414|NCT00621543|Primary|Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.||Three months|||percentage of participants||95% Confidence Interval|Mean
122415|NCT00621517|Primary|Ordinal Scale(i.e., 1-8)of Symptom Severity||three weeks and six weeks||||||
122416|NCT00621517|Primary|Clinical Global Impression - Improvement Scale||three weeks and six weeks||||||
122603|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122417|NCT00621517|Primary|Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.|Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.|Baseline, three weeks, and six weeks|Intention to Treat||points on a scale||Standard Deviation|Mean
122418|NCT00621504|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit||||||
122419|NCT00621504|Secondary|Microbiological Re-infection/Recurrence at LFU||21 to 35 days after last dose of study drug||||||
122420|NCT00621504|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug||||||
122421|NCT00621504|Secondary|Clinical Relapse at Late Follow Up (LFU)||21-35 days after last dose of study drug||||||
122422|NCT00621504|Secondary|Clinical and Microbiological Response by Pathogen at TOC||8-15 days after last dose of study drug||||||
122423|NCT00621504|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)||8-15 days after last day of study drug||||||
122424|NCT00621504|Secondary|Microbiological Success Rate at Test of Cure (TOC)||8-15 days after last dose of study drug||||||
122425|NCT00621504|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration||||||
122426|NCT00621504|Primary|Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary~Failure: Any of the following:~Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy~Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia~Death wherein pneumonia (ie,CABP) was considered causative~Indeterminate: Inability to determine an outcome"|8 to 15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.||participants|||Number
122427|NCT00621348|Secondary|Incidence of Symptomatic Hypernatremia|Symptomatic hypernatremia is defined as serum sodium > 150 mmol/L and the presence of symptoms like altered sensorium, seizure, headache and vomiting not explained otherwise.|72 hrs|Intention to Treat analysis||participants|||Number
122428|NCT00621348|Secondary|Incidence of Symptomatic Hyponatremia|Defined as Hyponatremia (serum sodium < 130 mnol/L)and presence of symptoms attributed to hyponatremia such as altered sensorium, seizure, headache, and vomiting which can not be explained otherwise.|72 hrs|||participants|||Number
122429|NCT00621348|Secondary|Incidence of Hypernatremia (Serum Sodium >150 mmol/L)||72 hrs|Intention To Treat analysis||participants|||Number
122430|NCT00621348|Primary|Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L)||72 hrs|432 patients were eligible. 203 patients were excluded and 62 patients declined consent . Out of 167 patients, 58 patients were randomized to Arm 1, 53 to arm 2 and 56 to arm 3.Intention to treat analysis was used.||participants|||Number
122431|NCT00621322|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) were expressed as geometric mean concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
122432|NCT00621322|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and IL-2 or IFN-γ or TNF-α; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.~For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
122433|NCT00621322|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.||T cells/million cells||Inter-Quartile Range|Median
122434|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122435|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 37|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
125639|NCT00593606|Primary|Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Ears, Eyes, Nose, Mouth, Throat’||28 days|Safety Set, only patients with non-missing values were analyzed||participants|||Number
122436|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122437|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122438|NCT00621322|Primary|Number of Subjects With Different Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophils [EOS], haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were- normal, below and above.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122439|NCT00621322|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122440|NCT00621322|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122441|NCT00621322|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms included fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122442|NCT00621322|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period, following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.||Subjects|||Number
122443|NCT00621296|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration||24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.|||participants|||Number
122444|NCT00621257|Secondary|Maintenance of 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|Percentage of participants with 25OHD >= 32 ng/ml at 4 follow up visits|12 months|||Participants|||Count of Participants
122445|NCT00621257|Primary|Treatment of Low 25 Hydroxy Vitamin D Levels in Pediatric Patients With Inflammatory Bowel Disease|Treatment : Pre-post treatment change in 25OHD concentration over 6 weeks|6 weeks|||ng/ml||Standard Deviation|Mean
122446|NCT00621192|Primary|Key Safety Endpoints|Safety assessments included death, seizure documentation (including correlation of serum meropenem level and seizures), strictures, perforation, wound dehiscence, short gut, development of extended beta lactamase infection, development of candidiasis, antimicrobial therapy failure|Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug)|Safety Population - The Safety Population includes all patients who receive any amount of meropenem.||Participants|||Number
122447|NCT00621192|Primary|Meropenem Clearance|Given the limited availability of blood for Pharmacokinetic (PK) assessments in this population a sparse sampling approach was utilized. Subjects were assigned to one of two Dose 1 sample collection schedules, “PK-odd” and “PK-even” based on birth date to ensure collection of PK data throughout the dose interval. In addition, PK samples were collected around approximately the 5th dose. Subjects that did not have Dose 1 PK samples could have steady-state (Dose 5) using the Dose 5 PK collection schedule.|Up to 7-8hrs post drug administration|||L/h/kg||Standard Deviation|Mean
122448|NCT00621192|Primary|Deaths||Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug)|The Safety Population includes all patients who receive any amount of meropenem.||Participants|||Number
124185|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse|Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42|Day 168|mITT population||participants|||Number
122449|NCT00621192|Primary|Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)|"The PCCS was derived by comparing clinical signs and symptoms prior to administration of the first dose of study drug and study Day 28.The elements of the PCCS include Mean BP,Temp,PaO2(mmHg)/FiO2,Lowest serum pH,seizures,Urine output,Cardiovascular inotrope support,C-reactive protein (CRP)and Abdominal girth.~Score - Asymptomatic to Asymptomatic 1;Asymptomatic to Worsening 0;Symptomatic to Worsening 0;Symptomatic to No change 0;Symptomatic to Improved 1;Symptomatic to Asymptomatic 1~If 7 or more of 10 signs received a score of 1, then the infant was considered a presumptive clinical cure.~GA stands for Gestational Age and PNA stands for Postnatal Age."|Average of 12 days (3 to 21 days)|The Efficacy Population includes all patients who have efficacy assessment (Clinical Signs) at Pre-Dose and Study Day 28 (or the day that the Day 28 assessments were taken).||Participants|||Number
122450|NCT00621153|Secondary|Compliance Levels at 4 Weeks and 8 Weeks of Therapy|Percent of the number of returened pills to the number of prescrited pills|8 weeks||||||
122451|NCT00621153|Secondary|Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE’s From Baseline (Randomisation) to the End of the Study (8 Weeks)|Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks|8 weeks||||||
122452|NCT00621153|Secondary|Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy|Change of hs-CRP from basline after 8 weeks|8 weeks||||||
122453|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy|Changed SBP from baseline after 8 weeks|8 weeks||||||
122454|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy|Percent of patients achieving goal of DBP|8 weeks||||||
122455|NCT00621153|Secondary|Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy|Percent of the patients achieving goal DBP and SBP after 4 weeks|4 weeks||||||
122456|NCT00621153|Secondary|Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy|Mean of the changed SBP from baseline after 4 weeks|4 weeks||||||
122457|NCT00621153|Primary|Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy|Mean of the changed DBP from baseline after 4 weeks|4 weeks|||mmHg||Standard Deviation|Least Squares Mean
122458|NCT00621140|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Mean
122459|NCT00621140|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
122460|NCT00621140|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||Percentage of Patients|||Number
122461|NCT00621140|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%.|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
122462|NCT00621140|Secondary|Percentage of Patients With HbA1c<7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
122463|NCT00621140|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
122464|NCT00621140|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
122465|NCT00621140|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
122466|NCT00621140|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124186|NCT00606580|Secondary|Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion||Day 42|||participants|||Number
122467|NCT00621140|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
122468|NCT00621140|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
122469|NCT00621140|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
122470|NCT00621140|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
122471|NCT00621140|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
122472|NCT00621049|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|||months||95% Confidence Interval|Median
122473|NCT00621049|Secondary|2-year Survival|Proportion of patients known to still be alive 2 years after coming on study|24 months|||percentage of participants|||Number
122474|NCT00621049|Secondary|Safety|Adverse Events occuring in >15% of patients|2 years|||participants|||Number
122475|NCT00621049|Primary|Disease-free Survival|The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.|1 year|||months||95% Confidence Interval|Median
122476|NCT00621023|Secondary|Number of Patients With an Unacceptable Toxicity|Any of the following non-hematologic toxicities that causes a patient's therapy to be suspended or discontinued: Creatinine > 2x baseline value; serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), Total bilirubin > 2x the upper limit of normal; Febrile neutropenia; Uncontrolled infection; Hepatotoxicity defined as an increase in serum bilirubin, SGOT, or alkaline phosphatase to >5 times baseline value); nephrotoxicity (defined as serum creatinine >3.5 times the ULN); neurological impairment (defined as somnolence, seizures, or impaired mentation); severe peripheral neuropathy, or any non-hematologic grade 4 toxic event.|During the treatment period and for 30 days after last dose of study drug|||participants|||Number
122477|NCT00621023|Secondary|Duration of a Complete or Partial Response Based on Number of People Who Responded.|Number of months a complete or partial response was maintained.|Up to 5 years or until death||||||
122478|NCT00621023|Primary|Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR)|Complete response and Partial response are defined using 2000 international working group (IWG) criteria. The Primary criteria for a CR is a repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia . A PR meets all the CR criteria except Blasts decreased by >50% over pretreatment, or a less advanced myelodysplastic syndrome (MDS) French American British (FAB) classification than pretreatment.|after 4 cycles of therapy|||participants|||Number
122479|NCT00620854|Primary|Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)|This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB|Per protocol, only subjects who completed all 3 treatments were analyzed.||% Change in Baseline CTx-1||Standard Error|Mean
122480|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Straight Leg Raise|Straight Leg Raise (SLR): number of people that can perform a SLR at designated intervals|4 hours, 8 hours, 12 hours and 24 hours post-op|||participants|||Number
122481|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome- Knee Extension and Flexion|Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort|24 hours post-op|||degrees||Standard Deviation|Mean
122482|NCT00620828|Secondary|Postoperative Day 1 Physical Therapy Outcome - Ambulation Distance|Ambulation distance walked by participants 24-hours post-operatively|24 hours post-op|||Feet||Standard Deviation|Median
122483|NCT00620828|Secondary|Total Fentanyl Patient-Controlled Anesthesia (PCA) Narcotic Consumption|The PCA total dose at the 4-hour, 8-hour, 12-hour and 24-hour post-operative time points.|4 hours to 24 hours post-op|||micrograms||Standard Deviation|Mean
122484|NCT00620828|Primary|Numeric Pain Score|Participants were asked to rate their pain on a scale of 0 to 10 at all time intervals up to 24 hours post-injection. Scores were organized into the following categories: 3 or less (mild pain), 4 to 6 (moderate pain), 7 or higher (severe pain).|Post-anesthesia care unit (PACU), 4 hours, 8 hours, 12 hours and 24 hours post-injection|per protocol||units on a scale||Standard Deviation|Mean
124187|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98||Days 98|mITT dataset||percentage of lesions|Participants|95% Confidence Interval|Number
122485|NCT00620815|Secondary|Mean T-Cells Per Million Total Cells (95% CI) in Response to H5 Peptides and H5N1 Subunit|"Frequency and functionality of vaccine antigen-specific CD4+ (cluster of differentiation 4) T cells was assessed in peripheral blood (PBMC) taken at days 1, 22 and 43 after in vitro stimulation with:~Library of 70 peptides spanning the whole H5 A/Vietnam/1194/2004 protein (H5 pool of 70 Vietnam) H5N1 subunit from A/Vietnam/1194/2004 (H5N1 Vietnam) H3N2 subunit from A/ Wisconsin/67/2005 (H3N2 Wisconsin) H1N1 subunit from A/Solomon Islands/3/2006 (H1N1 Solomon Islands) Polyclonal stimulus agonistic aCD3 mAb [monoclonal antibody (aCD3)].~The change in frequency of T-cells was measured."|Three weeks after 1st vaccination (day 22) and three weeks after 2nd vaccination (day 43)|Analysis was done on full analysis set||Mean cells per million total cells||95% Confidence Interval|Mean
122486|NCT00620815|Secondary|Percentages of B-cell Antibodies Against H5N1 and H1N1 After Each Vaccination.|"The Cell Mediated Immunity (CMI) response was evaluated in a randomly selected subgroup of approximately 92 subjects from all the vaccine groups out of a total of 601 enrolled subjects.~Frequency of circulating memory B cells (MBC), capable of differentiating in vitro into cell secreting IgG (Immunoglobulin G) antibodies specific for H5N1 (the subunit from A/Vietnam/1194/2004) or for H1N1 (the subunit from A/Solomon Island/3/2006) were determined by an ELISA-coupled limiting dilution assay.The frequency of H5N1-IgG MBC and H1N1-IgG MBC was expressed as percentages (%) of total IgG producing MBC."|Three weeks after first vaccination (day 22) and three weeks after second vaccination (day 43)|The analysis was done on Full analysis set||Percentages of B-cell antibodies||95% Confidence Interval|Mean
122487|NCT00620815|Secondary|Antibody Response Determined by HI and MN Assay.|Measurement of immunogenicity in terms of Geometric mean titers (GMTs) as determined by HI and MN assay.|Up to 43 days|The population was analyzed on Per protocol set||titers||95% Confidence Interval|Mean
122488|NCT00620815|Secondary|Percentages of Subjects Achieving HI/MN ≥ 1:40 and SRH Area ≥ 25^mm2|Measurement of immunogenicity in terms of percentage of subjects achieving a titre ≥ 40/area ≥ 25mm^2 after immunization as determined by HI (Haemagglutination Inhibition), MN(Microneutralization) and SRH assay.|Up to 43 days|The analysis was done on Per Protocol Set||Percentages of subjects||95% Confidence Interval|Number
122489|NCT00620815|Secondary|Percentages of Subjects Achieving Seroconversion/Significant Increase in Antibody Titre/ Area as Measured by SRH and (HI) and at Least 4 Fold Rise in Titres by Micro-neutralization (MN) Assay-H5N1 Strain|"Measurement of immunogenicity in terms of significant increase in antibody titer and Seroconversion.~Significant increase in antibody titer is defined as at least a four-fold increase from non-negative pre-vaccination serum (≥ 10) for HI or a 50% increase in area for SRH.~Seroconversion is defined as negative pre-vaccination serum / post-vaccination titer ≥40 for HI (area ≥25 mm2 for SRH)"|up to day 43|The population was analyzed on per protocol set.||Percentage of subjects||95% Confidence Interval|Number
122490|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Systemic Reactions After 1st and 2nd Vaccinations.|Systemic reactions were collected upto 7 days after 1st and 2nd vaccinations. All subjects were instructed to complete a diary card to record systemic reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|7 days after 1st and 2nd vaccinations each|The analysis was performed on Per Protocol Safety Population||Participants|||Number
122491|NCT00620815|Secondary|Number of Subjects (Subjects ≤60 Years) With Reported Local Reactions After Second Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization.|Up to 7 days after 2nd vaccination|The analysis was performed on Safety Population||Participants|||Number
122492|NCT00620815|Secondary|Number of Subjects (Subjects ≤ 60 Years) With Reported Local Reactions After First Vaccination|Local reactions were collected up to 7 days after 1st vaccinations. All subjects were instructed to complete a diary card to record local reactions starting on the day of vaccination (after 6 hours) and for each of the 6 days following each immunization. The table represents local reactions after first vaccination in each arm differently.|Up to 7 days after 1st vaccination|The analysis was performed on Safety Population||Participants|||Number
122493|NCT00620815|Primary|To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43.|"The antibody response was determined by SRH assay. Geometric mean areas (GMAs) and geometric mean ratios (GMRs) in the SRH assay were used to demonstrate the equivalence.~The statistical analysis was done based on the GMRs."|up to day 43|The analysis was done on Per Protocol Set (PPS)||Area (mm^2)||95% Confidence Interval|Geometric Mean
122494|NCT00620776|Secondary|50 Percent or Greater Reduction in PSWQ Score|Clinically significant change was defined on the PSWQ as an estimated (based on linear mixed effects model) endpoint score of less than 50.9. This score was calculated using the PSWQ normative data provided by Gillis, Haaga, and Ford (1995) and the baseline PSWQ mean and standard deviation (SD) from the current sample. The PSWQ mean and SD from the normative and current GAD samples were entered into the Jacobson et al. (1984) formula “c” for clinically significant change. This method provides a cutoff indicating whether or not the level of functioning by a patient is statistically more likely to be in the functional rather than the dysfunctional population.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|||Participants|||Count of Participants
122495|NCT00620776|Secondary|Clinical Response Rate|Clinical response on the HAM-A was defined as a 50% or greater reduction from baseline to last value with the 24-week open label medication phase.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|||Participants|||Count of Participants
122496|NCT00620776|Secondary|Mental Component Score of the 12-item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
122529|NCT00620542|Secondary|Non-HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
122497|NCT00620776|Secondary|Physical Component Score of the 12-Item Short Form Survey (SF-12)|The Short Form (12) Health Survey is a 12-item, patient-reported survey of patient health. Physical and Mental Health Component Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
122498|NCT00620776|Secondary|Penn State Worry Questionnaire (PSWQ)|The Penn State Worry Questionaire is a 16-item inventory that aims to measure the trait of worry, using Likert rating from 1 (not at all typical of me) to 5 (very typical of me). A total score is calculated (range = 16 to 80), with higher scores indicating greater worry.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
122499|NCT00620776|Secondary|Quality of Life Subscale of the General Health Questionnaire (GHQ)|The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions. Patients completed the 12 quality of life questions (each on a 0 to 3 scale) on this questionnaire. Scores on the 12 items were added up to create summary score (range = 0 to 36). Higher scores indicate worse health.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
122500|NCT00620776|Secondary|Clinical Global Impression (CGI)-Improvement Score|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale (1= very much improved; 7 = very much worse) that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at different time points varies due to patient dropout.||units on a scale||Standard Deviation|Mean
122501|NCT00620776|Secondary|Clinical Global Impression (CGI)-Severity Score|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale (1=normal; 7 = extremely ill) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. Evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at each time point differs due to patient dropout.||units on a scale||Standard Deviation|Mean
122502|NCT00620776|Secondary|Hamilton Rating Scale for Depression (HAM-D)-17-item Score|The 17-item version of the HAM-D was used to assess severity of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.The total score is the sum of the 17 items, with a range from 0 to 50. A higher scores indicates greater depression. The ratings were conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 12, and week 24|Numbers analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
122503|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Depression Score|The HAD was used to assess patients’ report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater depression.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
122504|NCT00620776|Secondary|Hospital Anxiety Depression Scale (HAD)-Anxiety Score|The HAD was used to assess patients’ report of anxiety and depressive symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates greater anxiety.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Numbers analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
122505|NCT00620776|Primary|Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate and 25–30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.|Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24|Number analyzed at various time points differ due to patient dropout.||units on a scale||Standard Deviation|Mean
122506|NCT00620763|Primary|Calcium Absorption|After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.|18 weeks|Analysis included only the 16 volunteers that completed both dietary interventions.||percentage of Calcium-47 absorbed||Standard Error|Mean
122507|NCT00620750|Primary|Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections||4 months|Per protocol||Percent of participants|||Number
122508|NCT00620711|Primary|Cap Cooled to 12 Degrees Without Reducing Rectal Temperature|Yes/no|6 hours|||participants|||Number
122509|NCT00620711|Primary|Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature.|Measurement of number of participants able to obtain 12 degree cap temperature|60 minutes intervals|all analysized||participants|||Number
122530|NCT00620542|Secondary|Triglycerides Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
124188|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49||Days 49|mITT dataset||percentage of lesions|Participants|95% Confidence Interval|Number
122510|NCT00620698|Secondary|Handheld Dynamometry|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months|||Coefficient of variation||95% Confidence Interval|Mean
122511|NCT00620698|Secondary|ALS Functional Rating Scale|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months|||Coefficient of variation||95% Confidence Interval|Mean
122512|NCT00620698|Primary|Electrical Impedance Myography|The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.|6 months|||Coefficient of Variation||95% Confidence Interval|Mean
122513|NCT00620659|Secondary|Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo|"The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with 'subjective sleepiness'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 (would never dose) to 3 (high chance of dozing). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse)."|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||units on a scale||Standard Error|Least Squares Mean
122514|NCT00620659|Secondary|Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo|Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||units on a scale||Standard Error|Least Squares Mean
122515|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||Minutes||Standard Error|Least Squares Mean
122516|NCT00620659|Secondary|Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||Minutes||Standard Error|Least Squares Mean
122531|NCT00620542|Secondary|HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
124189|NCT00606580|Secondary|Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42||Days 42|mITT dataset||Percentage of lesions|Participants|95% Confidence Interval|Number
122517|NCT00620659|Primary|Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.|At Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.||Minutes||Standard Error|Least Squares Mean
122518|NCT00620555|Secondary|Percent Change in Seizure Frequency|Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."||Percent change||Full Range|Median
122519|NCT00620555|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."||Percentage of participants||95% Confidence Interval|Number
122520|NCT00620555|Secondary|Response Ratio|The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473).|Up to 52 weeks|"Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point."||Ratio||Standard Deviation|Mean
122521|NCT00620555|Primary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|up to 53 weeks|Safety analysis set: All paticipants who have received at least one dose of the study drug.||Participants|||Number
122522|NCT00620542|Secondary|VLDL-C During the 104 Week Treatment Period|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
122523|NCT00620542|Secondary|Apoliprotein B/Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
122524|NCT00620542|Secondary|Apolipoprotein A-1 Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
122525|NCT00620542|Secondary|Apolipoprotein B Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
122526|NCT00620542|Secondary|Non-HDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
122527|NCT00620542|Secondary|Total Cholesterol/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
122528|NCT00620542|Secondary|LDL-C/HDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Ratio||Standard Error|Least Squares Mean
122532|NCT00620542|Secondary|LDL-C Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
122533|NCT00620542|Secondary|Total Cholesterol Blood Level|Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.|104 weeks|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mg/dL||Standard Error|Least Squares Mean
122534|NCT00620542|Secondary|Numbers of Patients Showing Regression in TAV|Regression defined as a change from baseline in TAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Participants|||Number
122535|NCT00620542|Secondary|Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)|Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||mm^3||95% Confidence Interval|Median
122536|NCT00620542|Secondary|Numbers of Patients Showing Regression in PAV|Regression defined as a change from baseline in PAV < 0|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Participants|||Number
122537|NCT00620542|Primary|Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)|"Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as:~[sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD."|End of study (Week 104)|Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).||Percent change||95% Confidence Interval|Median
122538|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon|"Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25.~Cmax (pg/mL): Peak concentration."|3 years|All-Subjects-Pharmacokinetically-Evaluable consisted of 103 subjects.Subjects excluded from PK evaluation due to age, use of by protocol prohibited steroidal medication during trial and contraceptives within one week prior to Implanon insertion and their pre-insertion ENG concentration was not proven to be below Lower Limit Of Quantification (LLOQ)||pg/mL||Full Range|Mean
122539|NCT00620464|Primary|Bioequivalence of Implanon® and Radiopaque Implanon.|"Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25.~AUC0-6months (Area under the curve from zero to six months).~AUC0-24months (Area under the curve from zero to 24 months).~AUC0-36months (Area under the curve from zero to 36 months)."|3 years|103 subjects were pharmacokinetically evaluable. Subjects were excluded from PK evaluation for use of protocol-prohibited steroidal medication during the trial or contraceptives within 1 week prior to Implanon insertion, or because their pre-insertion ENG concentration was not proven to be below the Lower Limit of Quantification (LLOQ)||pg•month/mL||Full Range|Mean
122540|NCT00620425|Primary|The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).|Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.|-15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose|||injections|Participants||Number
122541|NCT00620373|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||percentage of participants||95% Confidence Interval|Number
122542|NCT00620373|Secondary|Specificity|Specificity measures the proportion of negatives which are correctly identified as such.|12 month after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging). The number of participants negative for breast cancer was 936-11 = 925.||number of true negatives|||Number
122543|NCT00620373|Primary|Number of Participants With Cancer Diagnosis at 12 Months||12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||participants|||Number
122544|NCT00620373|Secondary|Sensitivity|Sensitivity measures the proportion of actual positives which are correctly identified as such.|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||number of cancers diagnosed|||Number
122545|NCT00620373|Primary|Diagnostic Yield|Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).|12 months after mammography and gamma imaging|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and gamma imaging).||cancers per 1000 women screened||95% Confidence Interval|Number
122563|NCT00620074|Secondary|Voriconazole Trough Levels With Intravenous and Oral Dosing|Voriconazole trough plasma concentrations measured as nanograms per milliliter (ng/mL).|Week 1 through Week 6|ITT; only 1 pharmacokinetic sample was collected for each subject, therefore a comprehensive analysis of trough plasma concentrations was not completed due to insufficient data.||ng/mL||Standard Deviation|Mean
125640|NCT00593606|Primary|Change in Uric Acid|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||µmol/l||Standard Deviation|Mean
122546|NCT00620282|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occurring from week 0 to week 12. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself and either plasma glucose was below 56 mg/dL or symptoms were reversed after food intake or glucagon/intravenous glucose administration. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.||episodes|||Number
122547|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Creatinine Values Outside Reference Range|Number of subjects with serum creatinine values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 0.600 mg/dL, upper value 1.100 mg/dL) Male (lower value 0.800 mg/dL, upper value 1.300 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.||participants|||Number
122548|NCT00620282|Secondary|Haematology and Biochemistry Tests - Number of Subjects With Blood Urea Nitrogen (BUN) Values Outside Reference Range|Number of subjects with serum BUN values outside reference range at Week 0 and Week 12, respectively. Reference range: Female (lower value 6.000 mg/dL, upper value 21.000 mg/dL) Male (lower value 8.000 mg/dL, upper value 25.000 mg/dL).|week 0, week 12|Safety population included all subjects exposed to at least one dose of the drug or who underwent at least one venous occlusion plethysmography (VOP) procedure.||participants|||Number
122549|NCT00620282|Secondary|Biomarkers of Cardiovascular Risk - Change in TNF-alpha|Change in TNF-alpha|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||pg/mL||Standard Error|Least Squares Mean
122550|NCT00620282|Secondary|Fasting Lipid Profile - Change in Triglycerides (TG)|Change in TG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
122551|NCT00620282|Secondary|Fasting Lipid Profile - Change in HDL-C|Change in HDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
122552|NCT00620282|Secondary|Fasting Lipid Profile - Change in LDL-C|Change in LDL-C|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
122553|NCT00620282|Secondary|Fasting Lipid Profile - Change in Total Cholesterol (TC)|Change in TC|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
122554|NCT00620282|Secondary|Change in Body Weight||week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||kg||Standard Error|Least Squares Mean
122555|NCT00620282|Secondary|Change in Mean Postprandial Glucose (PPG) Based on Self-measured 7-point Plasma Glucose Profiles|The 7-point profile included plasma glucose measurements at the following time points: before each main meal (breakfast, lunch and dinner), 90 minutes after the start of each main meal (breakfast, lunch and dinner) and at bedtime.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
122556|NCT00620282|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in FPG|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mg/dL||Standard Error|Least Squares Mean
122557|NCT00620282|Secondary|Change in HbA1c (Glycosylated Haemoglobin A1c)|Percentage point change in HbA1c|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||percentage of total haemoglobin||Standard Error|Least Squares Mean
122558|NCT00620282|Secondary|Change in Sodium Nitroprusside (SNP)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in SNP-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mL/100 mL/min||Standard Error|Least Squares Mean
122559|NCT00620282|Primary|Change in Acetylcholine (ACh)-Mediated Forearm Blood Flow (FBF)|Assessed endothelial function by measuring the change in ACh-mediated FBF at euglycemia (90 mg/dL) using forearm venous occlusion plethysmography (VOP) technique. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|week 0, week 12|The ANCOVA full analysis set (FAS) includes all randomised subjects for whom data points could be collected at end of trial.||mL/100 mL/min||Standard Error|Least Squares Mean
122560|NCT00620126|Primary|Percentage of Participants Adherent to Therapy|Adherence was assessed using the Morisky Medication Adherence Score, a 4 item survey in which participants self-report medication-taking behavior. Each question that is answered with a No receives a score of 1. The possible scoring range is therefore 0 to 4. Higher scores correlate with better medical adherence. For the purpose of evaluating percent of participants adherent to therapy, the variable was dichotomized to “Adherent” or “Non-adherent”. Any response of Yes to one of the 4 items was scored as “Non-Adherent”.|12 Months|||Percentage of Participants|||Number
122561|NCT00620126|Primary|Quality of Life (IBDQ)|Disease-specific quality of life was assessed using the IBD questionnaire (IBDQ). Scores for the IBDQ range from 32 to 224 with higher scores being associated with better quality of life. Score changes of 16 have been found to be significant changes when compared to baseline values.|12 Months|||Units||Standard Deviation|Mean
122562|NCT00620126|Primary|Clinical Disease Activity (Seo Index)|Clinical disease activity was assessed using the Seo index. An activity index <120 represents clinical remission, whereas scores of 121-150, 151-220, and >221 correlate with mild, moderate, and severe disease respectively. The Seo index is sensitive to change, with a decrease in the index of 35 correlating with a clinical response.|12 months|||Units||Standard Deviation|Mean
124728|NCT00603239|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||kg||Standard Error|Least Squares Mean
122564|NCT00620074|Secondary|Galactomannan Titer Assay Levels and Global Response|Number of subjects per Galactomannan titer level with global response for all subjects (with or without renal impairment). The galactomann assay is an immunological blood serum test used to diagnose invasive aspergillosis and to monitor disease progression. Global response is a composite of clinical and radiological findings summarized as Complete Response: resolution of all clinical signs and symptoms; Partial Response: clinical improvement; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Up to Week 6|ITT. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.||participants|||Number
122565|NCT00620074|Secondary|Summary of Mortality|Number of subects with documented mortality (death).|Up to Week 6|ITT||participants|||Number
122566|NCT00620074|Secondary|Summary of Global Response at Week 2, Week 4, and Week 6|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|Week 2, Week 4, Week 6|ITT; due to low study enrollment, data not summarized by global response at Week 2, Week 4, and Week 6. Cross-reference outcome measure: Summary of Global Response at End of Treatment (EOT).||participants|||Number
122567|NCT00620074|Primary|Summary of Global Response at End of Treatment (EOT)|Number of subjects with global response consisting of a combination of clinical and radiological findings at the end of therapy. Possible outcome categories: Complete Response: resolution of all clinical signs and symptoms and more than 90% of lesions due to invasive aspergillosis that were visible on radiological studies; Partial Response: clinical improvement and greater than 50% improvement in radiological findings; Stable Response: no change from baseline or an improvement of less than 50% in radiological findings; Failure (no response): worsening disease.|End of Treatment (Day 42)|Intent-to-treat (ITT): includes all subjects who received at least 1 dose of study medication. No descriptive or inferential analysis was completed due to low enrollment and subsequent early termination of study.||participants|||Number
122568|NCT00620035|Primary|Implant Removal Time (Seconds)|The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals.||Seconds||Standard Deviation|Mean
122569|NCT00620035|Primary|Implant Insertion Time (Seconds)|The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.|Day 1|All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions.||Seconds||Standard Deviation|Mean
122570|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
122571|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
122572|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator & the implant. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
122573|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality|In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
122574|NCT00620035|Primary|Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects|In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.|Day 1|The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.||Percentage of Applicator Users|||Number
122602|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122575|NCT00620022|Secondary|Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose|At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified-intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.||Liters||Standard Error|Least Squares Mean
122576|NCT00620022|Primary|Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period|At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.|End of each 3 week treatment period (last day of Weeks 3 and 9)|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.||Seconds||Standard Error|Least Squares Mean
122577|NCT00619970|Primary|Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment||baseline (week 0) and at 2 weeks post treatment|1 patient from the treatment group withdrew from the study. Four additional children, 2 from the treatment group and 2 from the placebo group, did not show up for their follow up breath test||Participants|||Count of Participants
122578|NCT00619970|Primary|The Number of Participants at Baseline With SIBO||upon enrollment|||Participants|||Count of Participants
122579|NCT00619957|Secondary|Cumulative Incidence of Fractures, 24 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years|Baseline to Month 24|ITT Population||Fractures / 100 patients / 2 years|||Number
122580|NCT00619957|Secondary|Cumulative Incidence of Fractures, 12 Months, ITT Population|Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year|Baseline to Month 12|ITT Population||Fractures / 100 patients / year|||Number
122581|NCT00619957|Secondary|Percent of Responders Lumbar Spine BMD, Month 24, ITT Population|responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24|Baseline to Month 24|ITT Population||Percentage of Participants|||Number
122582|NCT00619957|Secondary|Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||millimeters||95% Confidence Interval|Least Squares Mean
122583|NCT00619957|Secondary|Change From Baseline in Body Height, Month 24, ITT Population.||Baseline to Month 24|ITT Population||millimeters||95% Confidence Interval|Least Squares Mean
122584|NCT00619957|Secondary|Change From Baseline in Body Height, Month 12, ITT Population.||Baseline to Month 12|ITT Population||millimeters||95% Confidence Interval|Least Squares Mean
122585|NCT00619957|Secondary|Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
122586|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 24, ITT Population.||Baseline to Month 24|ITT Population||percent||95% Confidence Interval|Least Squares Mean
122587|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 12, ITT Population.||Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122588|NCT00619957|Secondary|Percent Change From Baseline in BAP, Month 6, ITT Population.||Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122589|NCT00619957|Secondary|Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.||Baseline to Month 3|ITT Population||percent||95% Confidence Interval|Least Squares Mean
122590|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
122591|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.||Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122592|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.||Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122593|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.||Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122594|NCT00619957|Secondary|Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.||Baseline to Month 3|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122595|NCT00619957|Secondary|Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.||Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
122596|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 24, ITT Population.||Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122597|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 12, ITT Population.||Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122598|NCT00619957|Secondary|Percent Change From Baseline in CTx, Month 6, ITT Population.||Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122599|NCT00619957|Secondary|Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.||Baseline to Month 3|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122600|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
122601|NCT00619957|Secondary|Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122604|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
122605|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122606|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122607|NCT00619957|Secondary|Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122608|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
122609|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122610|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122611|NCT00619957|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122612|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122613|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122614|NCT00619957|Secondary|Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to Month 6|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
122615|NCT00619957|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.|DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).|Baseline to 24 Months/Endpoint|ITT Population, LOCF (Last Observation Carried Forward)||Percent Change||95% Confidence Interval|Least Squares Mean
122616|NCT00619918|Secondary|Supplemental Medication Use||14 days||||||
122617|NCT00619918|Secondary|IV Fluid Use||14 days||||||
122618|NCT00619918|Secondary|Hours of Oxygen Use||14 days||||||
122619|NCT00619918|Primary|Change in RDAI Score||1 day||||||
122620|NCT00619918|Primary|Length of Stay|Length of stay defined as date of discharge minute date of admission.|1 month|||Days||Standard Deviation|Mean
122621|NCT00619918|Primary|Admission Rate|Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.|1 day|||participants|||Number
122649|NCT00619619|Other Pre-specified|Change From Baseline in Hamilton Rating Scale for Depression 17-item (HAMD-D17) Total Score|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT||Score on a scale||Standard Deviation|Mean
122622|NCT00619892|Secondary|Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).|Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM‑A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.|Comparing baseline and the end of 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
122623|NCT00619892|Primary|Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores|Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.|Baseline and the end of 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
122624|NCT00619827|Primary|Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours|The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (]0-4] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS ]0-4] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.|4 months|The Intent-to-treat (ITT) population included all randomised subjects who received at least one dose of the investigational product.||Units on a scale (range: 0 to 18)||Standard Error|Mean
122625|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [µmol/L]||Full Range|Median
122626|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen||Baseline, 14 days|Safety Population; only non-missing values were analyzed||millimole per liter [mmol/L]||Full Range|Median
122627|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
122628|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||unit per liter [U/L]||Full Range|Median
122629|NCT00619801|Secondary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin||Baseline, 14 days|Safety Population; only non-missing values were analyzed||micromole per liter [µmol/L]||Full Range|Median
122630|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
122631|NCT00619801|Primary|Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|7 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
122632|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF)|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
122633|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval|The QT interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
122634|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration|The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
122635|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval|The PR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
122636|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval|The RR interval refers to the respective time interval in the Electrocardiogram (ECG).|Baseline, 14 days|Safety Population; only non-missing values were analyzed||milliseconds||Standard Deviation|Mean
122637|NCT00619801|Primary|Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)||Baseline, 14 days|Safety Population; only non-missing values were analyzed||beats per minute||Standard Deviation|Mean
122648|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Severity (CGI-S) Score at Every Visit|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-S score of 6 or 7, therefore only scores 1 through 5 are reported.||percentage of participants|||Number
122659|NCT00619489|Primary|Number of Participants With Clinically Significant Laboratory Findings|Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are enzymes in the blood.|through Day 637|Safety analysis set||participants|||Number
122638|NCT00619762|Primary|Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix|Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response & revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization & immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed & if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of “sparse or light” distribution & 3 HP fields of dense distribution counted & results averaged. Tissue sample then assessed for overall acellularity & expressed as %.|At the time of expander/implant exchange (Stage II),|All implanted patients enrolled in the study were included in the analysis||percentage of breasts|Participants||Number
122639|NCT00619762|Secondary|Severity of Local Inflammation at and Around the Surgical Site|The Inflammatory response was evaluated by each of the four cardinal signs: erythema, edema, pain and heat, using standard scales for the evaluation of each sign and inflammation as a whole was assessed using a model (AIR Score) which took into account the scores assigned to each of the four signs. A mean score is provided at each timepoint.The minimum total possible score is 4 (less inflamation) and the maximum total possible score is 8 (more inflammation).|Postoperative Day 7, 14, 21, 30 days|Total breasts enrolled were 29. Day 7, N = 28 breasts available Day 14, N = 27 breasts available Day 21, N = 27 breasts available Day 30, N = 25 breasts available||units on a scale|Participants|Standard Deviation|Mean
122640|NCT00619619|Other Pre-specified|Percentage of Participants With a Categorical Clinical Global Impressions Scale-Improvement(CGI-I) Score at Every Visit|CGI-I: 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT; no participants had a CGI-I score of 6 or 7, therefore only scores 1 through 5 are reported.||percentage of participants|||Number
122641|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.||(ng*hr/mL)/mg of dose|||Number
122642|NCT00619619|Secondary|Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method|Relationship of variables (i.e., age, sex, ethnicity, and food) examined by fitting dose normalized AUC (AUC/D) values to a power model. AUC/D regressed against variables using power equation Y=A*W^b (Y=AUC/D; A=coefficient; W=variable; b=exponent). AUC values from children cohort (ages 7 to 11) combined doses=first method of analysis. AUC from adolescent cohort (ages 12 to 17) combined doses=second method of analysis. AUC values combined from both cohorts=third method of analysis. Measured as nanograms multiplied by hours divided by milliliters per milligram of dose [(ng*hr/mL)/mg of dose].|Day 1, Day 28, and Day 56|PK population; data was insufficient examine the effect of age, sex, ethnicity, and food on the PK of desvenlafaxine. Coefficient and exponent values were calculated for variable of body weight, however, the AUC/D values were not summarized as descriptive statistics.||(ng*hr/mL)/mg of dose|||Number
122643|NCT00619619|Primary|Area Under the Curve From Time Zero to Infinity (AUC0-∞)|AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to infinity. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population||ng*hr/mL||Standard Deviation|Mean
122644|NCT00619619|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population||hr||Standard Deviation|Mean
122645|NCT00619619|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Noncompartmental PK parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as hours (hr).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population||hr||Standard Deviation|Mean
122646|NCT00619619|Primary|Maximum Observed Plasma Concentration (Cmax)|Noncompartmental pharmacokinetic (PK) parameter obtained using 0 to 72 hour concentration data from venous blood samples measured as nanograms per milliliter (ng/mL).|Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56|PK population: all participants in the Safety population with available plasma concentration data from both the inpatient and outpatient phases of the study that are properly identified with respect to dosing and sampling times.||ng/mL||Standard Deviation|Mean
122647|NCT00619619|Primary|Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs are adverse events that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability or incapacity, result in cancer, or result in a congenital anomaly or birth defect.|Baseline to Follow-up (up to Day 77)|Safety population includes all treatment-assigned participants who have taken at least 1 dose of study treatment.||participants|||Number
122650|NCT00619619|Other Pre-specified|Change From Baseline in Children's Depression Ratings Scale-Revised (CDRS-R) Total Score|CDRS-R total score: scale measures 17 depressive symptoms, of which 3 are rated 1 to 5 and 14 are rated 1 to 7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17 to 113. Lower total scores indicate lower intensity of symptoms.|Baseline, Inpatient Days 1 to 4, Outpatient Days 5 to 7, Outpatient Weeks 2 through 8 and Outpatient Week >8 (or early termination)|ITT: all treatment-assigned subjects with a baseline primary efficacy evaluation, at least 1 dose of study treatment, and at least 1 primary efficacy evaluation after the first dose of study treatment.||scores on a scale||Standard Deviation|Mean
122651|NCT00619502|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|"Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable."|Day 0 up to Day 7 post-booster vaccination|Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP~T according to the primary series received (Safety Analysis Population).||Participants|||Number
122652|NCT00619502|Primary|Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T|Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).|Day 0 before and Day 30 post-booster vaccination|GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
122653|NCT00619502|Primary|Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™|Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.|Day 0 before and Day 30 Post-booster vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.||Percentage of Participants|||Number
122654|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal address in cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay at time points where at least 50% of participants in the analysis set had non-missing results. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.||percent MADCAM binding||Standard Deviation|Mean
122655|NCT00619489|Secondary|Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay|The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the ACT-1 binding interference assay. ACT-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percentage of cells bearing α4β7 that were not saturated with vedolizumab at the time of sampling.|Days 43, 99, 155 and 267, predose|Pharmacodynamic (PD) Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PD parameters. Participants without dose modification and with available PD data at each time point are included.||% ACT1 binding||Standard Deviation|Mean
122656|NCT00619489|Secondary|Serum Concentration of Vedolizumab Before Dosing|Vedolizumab serum concentrations were measured from serum samples collected for pharmacokinetic (PK) analysis within 2 hours prior to dosing. The original protocol specified that PK parameters, including but not limited to minimum plasma concentration (Cmin), were to be estimated; however, due to intrapatient dose modification with Amendment 1, it was no longer feasible to perform a full PK parameter estimation. The summaries of pre-infusion data (i.e., trough levels) are presented at time points where at least 50% of participants had quantifiable vedolizumab concentrations, using a value of 0 for results below a measurable range. This provides information on the pharmacokinetic behavior of vedolizumab when administered as long-term therapy.|Days 43, 99, 155 and 267, predose|"The PK Population included all participants who received at least 1 dose of vedolizumab and had sufficient blood sampling for estimation of PK parameters. Participants without dose modification and with available serum concentration data at each time point (indicated by n) are included."||μg/mL||Standard Deviation|Mean
122657|NCT00619489|Primary|Number of Participants With Human Anti-human Antibodies (HAHA)||Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.|Safety analysis set||participants|||Number
122658|NCT00619489|Primary|Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML)|At every visit, before receiving study treatment participants were evaluated by clinic staff for signs of PML using a PML symptom checklist.|through Day 637|Safety analysis set||participants|||Number
122660|NCT00619489|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.~The intensity for each AE was defined according to the following criteria:~Mild: Awareness of sign or symptom, but easily tolerated; Moderate: Discomfort enough to cause interference with normal daily activities; Severe: Inability to perform normal daily activities."|From Day 1 to Day 637|Safety analysis set, defined as all enrolled participants who received at least 1 dose of study drug. Analysis was based on the lowest dose received, rather than dose at randomization.||participants|||Number
122661|NCT00619476|Secondary|Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The CGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.||participants|||Number
122662|NCT00619476|Secondary|Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data|The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||points on a scale||Standard Error|Least Squares Mean
122663|NCT00619476|Secondary|Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data|The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||points on a scale||Standard Error|Least Squares Mean
122664|NCT00619476|Secondary|Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data|The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts.||points on a scale||Standard Error|Least Squares Mean
122665|NCT00619476|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (Week 13 or early withdrawal)|ITT Population. There was one participant in the GEn 1200 mg and two in the GEn 2400 mg group who did not have enough data available to calculate the rescue mediation consumed while on treatment.||milligrams||Standard Error|Least Squares Mean
122666|NCT00619476|Secondary|Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score|Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as the first day of event minus the last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.|Anytime post-baseline until date of last dose of study medication (up to Week 13)|ITT Population||days||Full Range|Median
122667|NCT00619476|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data|Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg and one in the GEn 2400 mg group who did not have enough data available to calculate the percent reduction.||participants|||Number
125641|NCT00593606|Primary|Change in Total Protein|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||g/dl||Standard Deviation|Mean
122668|NCT00619476|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week13/Withdrawal visit."|EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The PGIC analysis included a subset of the ITT Population who completed the PGIC questionnaire at the end of treatment.||participants|||Number
122669|NCT00619476|Secondary|Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data|Dynamic allodynia (pain in response to a standardized light touch stimulus, a foam brush applied with light pressure to the site of maximum pain) was assessed by an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NRS analysis included a subset of the ITT Population who completed that NRS at both the Baseline and the Week13/Withdrawal Visit.||points on a scale||Standard Error|Least Squares Mean
122670|NCT00619476|Secondary|Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data|The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The SF-MPQ analysis included a subset of the ITT Population who completed a SF-MPQ assessment at both Baseline and the Week 13/Withdrawal Visit.||points on a scale||Standard Error|Least Squares Mean
122671|NCT00619476|Secondary|Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data|The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. The NPS summary included a subset of the ITT Population that completed an NPS assessment at both Baseline and Week 13/Withdrawal.||points on a scale||Standard Error|Least Squares Mean
122672|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1220 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EOMT timepoint.||points on a scale||Standard Error|Least Squares Mean
122673|NCT00619476|Secondary|Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate a score for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
122674|NCT00619476|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 1200 mg group and two in the 2400 mg group who did not complete enough post-baseline evening diaries to calculate an API for the EOMT timepoint.||points on a scale||Standard Error|Least Squares Mean
122675|NCT00619476|Secondary|Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate a score for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
122688|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score|This is defined as the sum of the scores for the “injection systems” section questions 1-9 and the “side effects” section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
122676|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data|Night-time worst pain is defined as the participant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
122677|NCT00619476|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used."|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EMOT timepoint.||points on a scale||Standard Error|Least Squares Mean
122678|NCT00619476|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data|Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline wss calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population. There was one participant in the GEn 2400 mg group and one in the 3600 mg group who did not complete enough post-baseline morning diaries to calculate an API for the EOMT timepoint.||points on a scale||Standard Error|Least Squares Mean
122679|NCT00619476|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data|Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as EOMT score minus Baseline score.|Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)|ITT Population: all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement.||points on a scale||Standard Error|Least Squares Mean
122680|NCT00619385|Primary|AUC Post Final Dose||7 days|||hour*ng/mL||Standard Deviation|Mean
122681|NCT00619385|Primary|Cmax Post Final Dose|To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.|7 days|||ng/mL||Standard Deviation|Mean
122682|NCT00619359|Secondary|No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)|The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.|Overall (the 120 hours following initiation of cisplatin chemotherapy)|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 2 patients (aprepitant group) had no vomiting data, and were excluded from this analysis.||Participants|||Number
122683|NCT00619359|Secondary|A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.|Delayed phase (25 to 120 hours following initiation of cisplatin).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 1 patient (aprepitant group) had no delayed phase data, and was not included in this analysis.||Participants|||Number
122684|NCT00619359|Primary|A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).|The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.|Overall (in the 120 hours following initiation of cisplatin chemotherapy).|FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.||Participants|||Number
122685|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score|This is defined as the sum of the scores for “side effects” section questions 9 to 11, corresponding to minimum possible total score of 3 and a maximum possible total score of 15. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
122686|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score|This is defined as the sum of the scores for the “side effects” section questions 5 to 8, with a minimum possible total score of 1 and a maximum possible total score of 20. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
122687|NCT00619307|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score|This is defined as the sum of the scores for the “injection systems” section questions 1-9, with a minimum possible total score of 9 and a maximum possible total score of 45. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
122689|NCT00619307|Primary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score|This is defined as the sum of the scores for the “side effects” section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.|4 weeks|ITT||MSTCQ score (units on a scale)||95% Confidence Interval|Mean
122690|NCT00619242|Primary|Ki-67|Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett’s esophagus.|Two weeks|The 3 subjects underwent therapy without complications however the study was terminated due to low accrual.|||||
122691|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 6 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 6 months|Full Analysis Set (FAS)||Participants|||Number
122692|NCT00619229|Secondary|The Difference in Color Vision Between Measurements at 3 Months After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to 3 months|Full Analysis Set (FAS)||Participants|||Number
122693|NCT00619229|Secondary|The Difference in Color Vision Between Measurements Immediately After Intervention and Measurements at Baseline|The difference in color vision after intervention in comparison to Baseline was assessed by the investigator as 'Changed from Normal to Pathologic', 'Finding unchanged', and 'Changed from Pathologic to Normal'.|From baseline to time immediately after intervention|Full Analysis Set (FAS)||Participants|||Number
122694|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 6 months|Full Analysis Set (FAS)||Unit on a scale||Standard Deviation|Mean
122695|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements at 3 Months After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to 3 months|Full Analysis Set (FAS)||Unit on a scale||Standard Deviation|Mean
122696|NCT00619229|Secondary|The Difference in Contrast Sensitivity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in contrast sensitivity was measured with the Pelli-Robson test, using a chart with letters arranged in groups of three. The first group has unit contrast and each subsequent group has a lower contrast. Passing a group means to read correctly at least two of the three letters. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents visual disability.|From baseline to time immediately after intervention|Full Analysis Set (FAS)||Unit on a scale||Standard Deviation|Mean
122697|NCT00619229|Secondary|Development of a Wet Age-related Macular Degeneration|"A wet age-related macular degeneration (AMD) is defined as the development of choroidal neovascularization of the study-eye (worse eye).~Development is categorized in Yes and No, where Yes means that a subject who had no wet AMD at Screening has developed a wet AMD at Week 29."|From baseline to 6 months|Full Analysis Set (FAS)||Participants|||Number
122698|NCT00619229|Secondary|Progression of the Dry Age-related Macular Degeneration|"Severity of the diagnosed dry age-related macular degeneration (AMD) was assessed in comparison to Baseline and classified as~Progression~Stabilization~Amelioration"|From baseline to 6 months|Full Analysis Set (FAS)||Participants|||Number
122699|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements at 6 Months After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 6 months|Full Analysis Set (FAS)||Lines read in ETDRS chart||Standard Deviation|Mean
122700|NCT00619229|Secondary|The Difference in Visual Acuity Between Measurements Immediately After Intervention and Measurements at Baseline|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to time immediately after intervention|Full Analysis Set (FAS)||Lines read in ETDRS chart||Standard Deviation|Mean
122701|NCT00619229|Primary|Difference in Visual Acuity Between Measurements at 3 Months After Drug Intervention and Measurements at Baseline (Assessed Within Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)|Difference in visual acuity was measured with the standard ETDRS chart with letters arranged in lines of five. The first line is assumed to have letters of a specific size and each subsequent line to consist of letters of a smaller size. The subject starts reading the first line and continues reading the following lines until failing a line. Passing a line means to name at least three of the five letters correctly.|From baseline to 3 months|Full Analysis Set (FAS)||Lines read in ETDRS chart||Standard Deviation|Mean
124207|NCT00605384|Secondary|Number of Participants With Genotypic Resistance Based on Analysis of Samples From Participants With HBV DNA ≥ 50 IU/mL at Weeks 48 and 96|HBV DNA ≥ 50 IU/mL = approximately 300 copies/mL|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
122702|NCT00619190|Secondary|Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks|The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment.|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.||units on a scale||Standard Deviation|Mean
122703|NCT00619190|Primary|Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks|The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.|Baseline to 12 weeks|Only 20 out of 21 total participants were analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.||units on a scale||Standard Deviation|Mean
122704|NCT00619190|Secondary|Clinical Global Impressions Scale - Severity Score (CGI-S)|"One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S).~The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients)."|Baseline to 12 weeks|Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.||units on a scale||Standard Deviation|Mean
122705|NCT00619177|Secondary|Physician Assessment of Efficacy|"Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.~The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on physician assessment of efficacy.||Participants|||Number
122706|NCT00619177|Secondary|Patient Assessment of Efficacy|"Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.~The patients have been placed into categories according to the points on a scale."|after approximately 4 weeks of treatment|Full analysis set (FAS). This analysis was performed on all patients in FAS with available data on the global assessment of general efficacy.||Participants|||Number
122707|NCT00619177|Secondary|Change From Baseline of Pain Intensity on Visual Analogue Scale|The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)|Approximately four weeks of treatment|Full analysis set (FAS): This analysis was performed on all patients in FAS with available data on pain intensity on VAS at baseline and final visit.||Units on a scale||Standard Deviation|Mean
122708|NCT00619177|Primary|Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2|Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|Baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).||Units on a scale||Standard Deviation|Mean
122709|NCT00619177|Primary|Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.|Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)|baseline and final visit (approximately 4 weeks)|A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).||Units on a scale||Standard Deviation|Mean
122710|NCT00619151|Primary|Aortic Mean Gradient|Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.|6 months|Analysis not performed due to study termination prior to analysis period.||mmHg||Standard Deviation|Mean
122711|NCT00619151|Primary|Effective Orifice Area (EOA)|Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.|6 month evaluation|Analysis not performed due to study termination prior to analysis period.||cm^2||Standard Deviation|Mean
122712|NCT00619112|Secondary|Toxicity Associated With the Dose-intense Temozolomide Treatment Schedule as Assessed by NCI CTCAE v3.0||Study start was 10.31.2007. Enrollment was completed on 12/22/2011||||||
122713|NCT00619112|Primary|Efficacy, as Measured by 6-month Progression-free Survival, of the Dose-intense Temozolomide Treatment Schedule; This Endpoint Was Measured From the First Day of Treatment Until Progression or 6month Mark From Treatment Initiation.||Study start was 10.31.2007. Enrollment was completed on 12/22/2011|||percentage of participants|Participants||Number
124253|NCT00605267|Secondary|Oestrogen Receptor (ER) Status|ER status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment|||Participants|||Number
122714|NCT00619099|Primary|The Overall Improvement Rate|"Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement.~Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Remission: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%.~Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%.~Marrow Complete Remission: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.~HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response."|Up to one year|Modified Intent to Treat (mITT) Population||Percentage of Participants|||Number
122715|NCT00619073|Primary|Change From Baseline in Platelet Surface Activated GPIIb-IIIa Complex at 45 Days After Intervention.|Value at 45 days after intervention minus value at baseline in platelet surface activated GPIIb-IIIa complex using flow cytometry.The types and concentrations of agonists used in the flow cytometry assays reported here were: ADP 0.5, 1, and 20 µmol/L; thrombin receptor activating peptide (TRAP) 1 and 20 µmol/L; and a combination of collagen 5 µg/mL and epinephrine 5 µmol/L. Mean Florescence Intensity (MFI) is used as unit of measure. MFI indicates relative degree of shift in fluorescence intensity of a population of platelets in arbitrary units.|Baseline and 45 days after intervention|||mean fluorescence intensity (MFI)||Standard Error|Mean
122716|NCT00619060|Primary|Participants With Adverse Events by Treatment.|Comparison of number of participants with adverse events by treatment.|30 Days|||participants|||Number
122717|NCT00618995|Secondary|Prostaglandin I Metabolite (PGI-M)|PGI-M in the Overall 24 Hour Collection Interval Following Administration on Day 7|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
122718|NCT00618995|Primary|Urinary 11-Dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent statistical analysis models/comparisons.||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
122719|NCT00618982|Other Pre-specified|Disease Control - mITT Population|Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.||Participants|||Number
122720|NCT00618982|Other Pre-specified|Tumor Response - mITT Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.||Participants|||Number
122721|NCT00618982|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to treat (ITT).||months||95% Confidence Interval|Median
122722|NCT00618982|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|Intent-to-treat (ITT).||months||95% Confidence Interval|Median
122723|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Time to Maximum Concentration (Tmax)|Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Tmax calculated; 31 participants in the 600 mg bid group that had Tmax calculated; 28 participants in the 800 mg bid group that had Tmax calculated.||hours||Full Range|Median
122724|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Maximum Observed Concentration in Plasma (Cmax)|Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had Cmax calculated; 31 participants in the 600 mg bid group that had Cmax calculated; 28 participants in the 800 mg bid group that had Cmax calculated.||mg/L||Geometric Coefficient of Variation|Geometric Mean
122725|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss)|AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.|PK Analysis Population. 32 participants in the 400 mg bid group that had an AUC(0-12)ss calculated; 23 participants in the 600 mg bid group that had an AUC(0-12)ss calculated; 19 participants and 20 participants in the 800 mg bid group that had an AUC(0-12)ss calculated, for sorafenib and M2 parameter respectively.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
122726|NCT00618982|Secondary|Pharmacokinetics (PK) Analysis – Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss)|AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.|Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose.|PK Analysis Population. 40 participants in the 400 mg bid group that had an AUC(0-10)ss calculated; 30 participants in the 600 mg bid group that had an AUC(0-10)ss calculated; 26 participants and 27 participants in the 800 mg bid group that had an AUC(0-10)ss calculated, for sorafenib and M2 parameter respectively.||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
122727|NCT00618982|Primary|Tumor Response - ITT (Intent to Treat) Population|Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the efficacy analysis was the intent-to-treat (ITT) population defined as all patients who received at least one dose of study medication with at least one valid tumor assessment post-baseline.||participants|||Number
122728|NCT00618982|Primary|Best Response - mITT (Modified Intent-to-treat) Population|Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.|The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.||Participants|||Number
122729|NCT00618956|Secondary|Change From Baseline in Mean HR Following 24-hour Treatment at Visit 6|Change from baseline to Visit 6 in HR based on ABPM is defined as the mean HR value at Visit 6 minus the corresponding mean HR value at baseline in the same 24-hour period.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||bpm||Standard Error|Mean
122730|NCT00618956|Secondary|Change From Baseline in Mean Heart Rate (HR) Following 24-hour Treatment at Visit 4|Change from baseline to Visit 4 in HR based on ABPM is defined as the mean HR value at Visit 4 minus the corresponding mean HR value at baseline in the same 24-hour period.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||bpm||Standard Error|Mean
122731|NCT00618956|Secondary|Change From Baseline in Mean SBP/DBP Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP value at Visit 6 minus the corresponding mean SBP/DBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||mm Hg||Standard Error|Mean
122732|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6|Change from baseline to Visit 6 in mean systolic blood pressure based on ABPM is defined as the mean SBP value at Visit 6 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach||mm Hg||Standard Error|Mean
122733|NCT00618956|Secondary|Change From Baseline in Mean Systolic Blood Pressure /Diastolic Blood Pressure for 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean SBP/DBP based on ABPM is defined as the mean SBP/DBP values at Visit 4 minus the corresponding mean SBP/DBP values at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||mm Hg||Standard Error|Mean
122734|NCT00618956|Primary|Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4|Change from baseline to Visit 4 in mean systolic blood pressure (SBP) based on ambulatory blood pressure monitor (ABPM) is defined as the mean SBP value at Visit 4 minus the corresponding mean SBP value at baseline in the same 12-hour period post-AM dose.|4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)|The analysis was based on Intent-To-Treat (ITT) population using Observed Cases (OC) approach.||mm Hg||Standard Error|Mean
122735|NCT00618839|Secondary|Viability of Allograft Tissues|Immunohistochemical staining for Ki67, a protein expressed only in proliferating cells.|At the time of allograft removal (~7 days)|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.||Ki67 positive cells/ total cells||Full Range|Median
122736|NCT00618839|Secondary|Appearance of Allograft Tissues|The following three point scale was used to assess the condition of skin allografts: pink and adherent (2 points); either pink or adherent but not both (1 point); or neither pink nor adherent (0 points).|StrataGraft and cadaver allograft appearance were performed every other day after placement and at the time of allograft removal and the values averaged for each subject.|Treatment for each patient was randomized such that each half of the wound site received StrataGraft or cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.||points||Standard Error|Mean
122737|NCT00618839|Primary|Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue.|The percentage take of the autografted area on each treatment site based on clinical judgement of visual and tactile assessments two weeks after autografting of wounds that had been temporarily covered with StrataGraft skin tissue.|two weeks post-autografting|Intrapatient treatment sites were randomized such that each half of the wound site received StrataGraft and the other half received cadaver skin. Therefore, each patient received StrataGraft and cadaver allograft.||Percent Area of Autograft Take (%)||Standard Deviation|Mean
122738|NCT00618813|Secondary|Event Free Survival|Disease progression, occurrence of a second malignant neoplasm (SMN)or death will be considered an analytic event. In all other cases, the patient will be considered censored at last contact.|From enrollment to event or 10 years from enrollment, whichever occurs first||||||
122739|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) – Week 29 to Week 37|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 29 to week 37|Two patients were not evaluated for DLT during weeks 29-37 because those patients did not complete that segment of protocol therapy.||participants|||Number
122740|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 23 to week 28|One patient was not evaluated for DLT during weeks 23-28 because the patient did not complete that segment of therapy.||participants|||Number
122741|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Week 13 to week 22|One patient was not evaluated for dose-limiting toxicity during weeks 13-22 because patient did not complete that segment of protocol therapy.||participants|||Number
122742|NCT00618813|Primary|Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12|The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.|Enrollment to week 12|Any patient who receives at least one cycle of protocol therapy, or who is removed from protocol therapy partly or solely because of a dose-limiting toxicity will be evaluable for this outcome.||participants|||Number
122743|NCT00618813|Primary|Incidence of Death|Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy|Length of protocol therapy (up to 37 weeks) plus 30 days|Any patient who receives at least one cycle of protocol therapy, or who dies as a result of complications of therapy prior to completing one cycle of therapy will be evaluable for this outcome||participants|||Number
122744|NCT00618787|Primary|Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.|At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.|Weeks 0 and 4|Per protocol||Percentage change||Full Range|Median
122745|NCT00618787|Secondary|Pain||5 weeks||||||
122746|NCT00618787|Primary|Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups||5 weeks||||||
122747|NCT00618774|Primary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|First administration of study treatment to 24 hours post last dosing of study treatment.|Treated set||participants|||Number
125642|NCT00593606|Primary|Change in Total Bilirubin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
122748|NCT00618774|Secondary|Seated Blood Pressure Normalisation at Trough|"Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months:~Optimal: SBP <120 mmHg and DBP <80 mmHg~Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg~High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg~No: SBP >=140 mmHg or DBP >=90 mmHg"|6 months and 12 months|FAS||percentage of participants|||Number
122749|NCT00618774|Secondary|Seated SBP Response Rate at Trough|Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months|6 months and 12 months|FAS||percentage of participants|||Number
122750|NCT00618774|Secondary|Seated DBP Response Rate at Trough|Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months|6 months and 12 months|FAS||percentage of participants|||Number
122751|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose SBP <140 mmHg|6 months and 12 months|FAS||percentage of participants|||Number
122752|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 6 and 12 Months|Percentage of patients whose DBP <90 mmHg.|6 months and 12 months|FAS||percentage of participants|||Number
122753|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
122754|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure|Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 20 / week 48|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
122755|NCT00618774|Secondary|Seated SBP Control Rate at Trough After 8 Weeks|Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment|Week 8|FAS||percentage of participants|||Number
122756|NCT00618774|Secondary|Seated DBP Control Rate at Trough After 8 Weeks|Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment|week 8|FAS||percentage of participants|||Number
122757|NCT00618774|Secondary|Change From Baseline in Seated Systolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
122758|NCT00618774|Secondary|Change From Baseline in Seated Diastolic Blood Pressure at Week 8|mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure|Baseline and week 8|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.||mmHg||Standard Deviation|Mean
122759|NCT00618774|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|52 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.||percentage of participants|||Number
122760|NCT00618748|Secondary|Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval)|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||millisecond (msec)||Standard Deviation|Mean
122761|NCT00618748|Secondary|Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||microgram/Liter||Standard Deviation|Mean
122762|NCT00618748|Secondary|Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint|HbA1c is a test that measures the amount of glycated hemoglobin in the blood over prolonged periods of time.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||percentage of glycated hemoglobin||Standard Deviation|Mean
122763|NCT00618748|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48|EPS symptoms measured by DIEPSS are grouped into 4 categories: Parkinsonism, akathisia, dystonia, and dyskinesia. Severity ranges from level 0 (none, normal) to 4 (severe). A participant is deemed to have EPS at endpoint if they have an abnormal endpoint. Normal baseline Parkinsonism is defined as a score not ≥3 on 1 item or ≥2 on 2 items; abnormal endpoint is a score ≥3 on 1 item or ≥2 on 2 items, or an increase of 3 on Parkinsonism total. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score ≥2 or an increase ≥2 from that baseline score.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with a normal baseline and an endpoint result. For Parkinsonism, normal baseline is defined as a score not ≥3 on 1 item or ≥2 on 2 items. Normal baseline akathisia, dystonia and dyskinesia is defined as a score <2.||percentage of participants|||Number
122764|NCT00618748|Secondary|Percentage of Participants With High Suicidality at Week 24 or Week 48|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit value.||percentage of participants|||Number
122765|NCT00618748|Secondary|Percentage of Participants With Emergence of Mania at Week 24 or Week 48|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All Randomized participants.||percentage of participants|||Number
122766|NCT00618748|Secondary|Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The scores for mania, depression, and overall illness each range from 1 (normal, not ill) to 7 (very seriously ill).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
122767|NCT00618748|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
122768|NCT00618748|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
122769|NCT00618748|Secondary|Change From Baseline in Weight at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||kilograms||Standard Deviation|Mean
122770|NCT00618748|Secondary|Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint||baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|Participants with non-missing baseline value and the specified visit result.||millimole/Liter||Standard Deviation|Mean
122771|NCT00618748|Primary|Percentage of Participants With Adverse Events Leading to Discontinuation|An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.|Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)|All randomized Participants.||percentage of participants|||Number
122772|NCT00618722|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT population||participants|||Number
122773|NCT00618722|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data||degrees||Standard Deviation|Mean
122774|NCT00618722|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:~1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT population with available data||units on a scale||95% Confidence Interval|Least Squares Mean
122775|NCT00618722|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.~0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.~Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population||percentage of participants|||Number
122776|NCT00618722|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data||units on a scale||Standard Deviation|Mean
122777|NCT00618722|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT population with available data||units on a scale||Standard Deviation|Mean
122789|NCT00618540|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6|||participants|||Number
122790|NCT00618540|Secondary|Platelet Engraftment|Incidence of platelet recovery and donor chimerism at Day 100.|Day 100|||participants|||Number
122791|NCT00618540|Secondary|Incidence of Chronic GVHD|Occurrence of symptoms in any organ system fulfilling the criteria of limited or extensive chronic GvHD (Appendix III), among patients surviving > 90 days with evidence of engraftment. Patients without chronic GvHD will be censored at time of death or last follow-up.|Day 100 and Month 6|||participants|||Number
122778|NCT00618722|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.~Severity of adverse events was determined using the following scale:~Mild: The participant is aware of a sign or symptom, but it is easily tolerated~Moderate: Discomfort or interference with usual activity~Severe: Incapacitating, with inability to engage in usual activity.~A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor’s opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:~was fatal~was life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~was a congenital anomaly/birth defect~other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety and Modified Intent to Treat (mITT) population including all randomized participants who received at least 1 dose of study drug and who had at least 1 post-baseline observation.||participants|||Number
122779|NCT00618618|Secondary|Visual Analogue Scale Pain Intensity Rating|Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)|Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12|"Safety/mITT subset with available data at each time point (indicated by N)"||units on a scale||Standard Deviation|Mean
122780|NCT00618618|Secondary|Change From Baseline in the Cervicomental Angle|The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||degrees||Standard Deviation|Mean
122781|NCT00618618|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations||From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/mITT subset||participants|||Number
122782|NCT00618618|Secondary|Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset||units on a scale||Standard Deviation|Mean
122783|NCT00618618|Secondary|Change From Baseline in Skin Laxity Rating|"Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:~1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement."|Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)|Safety/mITT subset||units on a scale||Standard Deviation|Mean
122784|NCT00618618|Secondary|Percentage of Participants With an SMF Response|Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||percentage of participants|||Number
122785|NCT00618618|Secondary|Percentage of Participants With a Response in the Subject Global Improvement Rating|"Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.~0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.~Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6."|4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||percentage of participants|||Number
122786|NCT00618618|Secondary|Change From Baseline in Subject Satisfaction With Appearance Rating Scale|"The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||units on a scale||Standard Deviation|Mean
122787|NCT00618618|Secondary|Change From Baseline in Submental Fat (SMF) Rating Scale Score|"The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)|Safety/mITT subset with available data||units on a scale||Standard Deviation|Mean
122788|NCT00618618|Primary|Number of Participants With Adverse Events|"The investigator determined the relationship of each adverse event to the administration of study drug.~Severity of adverse events was determined using the following scale:~Mild: The participant is aware of a sign or symptom, but it is easily tolerated~Moderate: Discomfort or interference with usual activity~Severe: Incapacitating, with inability to engage in usual activity.~A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor’s opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:~was fatal~was life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~was a congenital anomaly/birth defect~other significant medical hazard"|From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).|Safety/miTT subset||participants|||Number
122809|NCT00618410|Secondary|Eosinophil Influx [Post-allergen]|The number of eosinophils per 200 white blood cells was counted for each nasal secretion scraping. The percentage of eosinophils was recorded.|after antigen challenge|||percentage of white blood cells||Full Range|Median
125643|NCT00593606|Primary|Change in Sodium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
122792|NCT00618540|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)|The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant.|Day 100 and Month 6|||participants|||Number
122793|NCT00618540|Secondary|Neutrophil Engraftment|Incidence of neutrophil recovery and donor chimerism at Day 100.|Day 100|||participants|||Number
122794|NCT00618540|Secondary|Transplantation-related Death|Count of patients who died by day 100 related to the transplantation.|Day 100|||participants|||Number
122795|NCT00618540|Primary|Disease-free Survival at 12 Months Post Transplantation|"This outcome is defined as survival with resolution of LCH at 12 months post transplant.~Unresolved disease for over 12 months post-transplant, progressive disease after this time period, recurrence of disease and death from any cause are considered events.~Those who survive with resolution of disease are censored at the date of last contact."|Year 1|||participants|||Number
122796|NCT00618540|Primary|Overall Survival|Count of patients alive at 1 and 3 years. Deaths from any cause are events. Surviving patients are censored at the date of last contact.|Year 1, Year 3|||participants|||Number
122797|NCT00618514|Secondary|Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event.|6 Months|||Limbs|Participants||Number
122798|NCT00618514|Secondary|Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.|Each subject completed a questionnaire to rate their satisfaction with the laser treatment. The score was reported as excellent, good, fair or poor. The best score of excellent was defined as “I am very satisfied with the laser treatment” and the worse score of poor was defined as “I am not satisfied with the laser treatment.” Each treated limb was scored by the patient at 6 months to determine the percent satisfaction at the 6-month time point.|6 months|||Percentage of participants|Participants||Number
122799|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.|Each subject completed a questionnaire to rate his/her pain. The scale is from 0-10 (0=no pain and 10=worst pain imaginable). Each treated limb was scored by the patient post-procedure and at 6 months to determine the improvement after treatment at the 6-month time point.|6 Months|||percentage of change|Participants|Standard Deviation|Mean
122800|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).|VDS is a physician’s evaluation of a patient’s ability to work an eight-hour day with or without a support device (i.e., compressive therapy, limb elevation). The patient is scored on a scale of 0-3 (0=asymptomatic and 3=unable to carry out usual activities (patients activities before the onset of disability due to venous disease) even with compression and/or limb elevation). The score represents the degree of disability caused by the venous disease with the best score being 0 and the worse score being 3. Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months|||percentage of change|Participants|Standard Deviation|Mean
122801|NCT00618514|Secondary|Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).|VCSS is a physician’s evaluation of 10 pre-determined clinical signs or attributes of venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, active ulcer duration, active ulcer diameter and compression therapy). Each attribute receives a score from 0-3 (0=absent and 3=severe). The best total overall score is 0 (all ten attributes are absent) and the worse overall score is 30 (all ten attributes are severe). Each treated limb was evaluated and scored at baseline and at 6 months.|6 Months|||percentage change|Participants|Standard Deviation|Mean
122802|NCT00618514|Primary|Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.|Each treated limb was clinically evaluated for the presence of a device-related serious adverse event.|6 Months|||Limbs|Participants||Number
122803|NCT00618514|Primary|Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.|The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.|6 Months|||Limbs|Participants||Number
122804|NCT00618449|Primary|Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]||1-year post-treatment|Per protocol.||Participants|||Number
122805|NCT00618436|Secondary|Incidence of Adverse Events||discharge; 3 and 6 months following injury||||||
122806|NCT00618436|Secondary|Disability Rating Scale (DRS)|The Disability rating scale (DRS) is frequently used in the rehabilitation literature as a measure of disability. It is a reliable, easily performed test that assesses 8 items (eye opening, verbalization, motor response, feeding, toileting, grooming, level of functioning, employability), and assigns each a numerical score ranging from 0 - 5 based on the category. The domains these 8 items are felt to assess include: alertness, cognition for self-care, dependence, and psychosocial adaptability. The scoring range is from 0-30, with increasing disability levels assigned to higher numerical values. The total DRS is then dichotomized into favorable (disability = none, mild, partial or moderate disability) and unfavorable (disability = moderately severe, severe, extremely severe, vegetative state, extreme vegetative state, death) outcomes. A DRS score of 0-6 was favorable, with any score greater than 6 categorized as unfavorable.|Discharge; 3 and 6 months following injury|All patients||units on a scale||Full Range|Mean
122807|NCT00618436|Secondary|Extended Glasgow Outcome Score|This is an 8 point validated scale that measures disability after brain injury. It is assessed through an in person exam or by phone interview at hospital discharge, 3 months and 6 months after injury. The categories are: 1 = dead; 2 = vegetative state; 3 = severe disability, low level; 4 = severe disability, high level; 5 = moderate disability, low level; 6 = moderate disability, high level; 7 = good recovery - low level; 8 = good recovery - high level. Specific questions and activities are assessed to determine into which category the patient falls.|at discharge; 3 and 6 months following injury|All patients||units on a scale||Full Range|Mean
122808|NCT00618436|Primary|Seizure Incidence|This was the number of patients in each group who demonstrated seizure activity during the course of the study|Duration of study, up to 6 months after the injury|||Participants|||Number
125644|NCT00593606|Primary|Change in Glutamic Pyruvic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
122811|NCT00618410|Secondary|Change From Diluent Challenge Contralateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.~Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.~The number reported in this outcome measure was calculated by subtracting the contralateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||ng/mL||Full Range|Median
122812|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Histamine Level at Antigen Challenge|"After collection of nasal secretions after diluent or antigen challenge, the filter paper disks were replaced in Eppendorf tubes and the disk/tube combination was weighed to record produced secretions. Three hundred microleters of 0.9% sodium chloride solution was then placed in the tubes and mediators were allowed to elute from the disks for 24 hours at 4 degrees Celsius. The eluate was then transferred to tubes and stored at -20 degrees Celsius until assayed for histamine.~Histamine was assayed by ELISA (Oxford Biomedical Research, Oxford, MI). The lower limit of detection of the assay is 2.5 ng/mL and samples below the detection limit were arbitrarily assigned a value of 1.25 ng/mL. The ipsilateral measure was taken from the challenge site.~The number reported in this outcome measure was calculated by subtracting the ipsalateral histamine level at diluent challenge from the analogous measure recorded after antigen challenge. Values may be positive or negative."|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||ng/mL||Full Range|Median
122813|NCT00618410|Secondary|Change From Diluent Challenge Ipsilateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Ipsilateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||milligrams||Full Range|Median
122814|NCT00618410|Primary|Change From Diluent Challenge Contralateral Secretion Weight at Antigen Challenge|Fifty microliters of challenge solutions were placed on the disks, which were then applied to the nasal septum for 1 minute. Thirty seconds after removal, two preweighed filter paper disks were placed on both sides of the nasal septum for 30 seconds, collecting nasal secretions from the challenge site (ipsilateral) and the contralateral nostril. These disks were then immediately placed back into microtubes and weighed. The difference in their weight before and after challenge was the weight of produced nasal secretions, which was recorded in milligrams. Contralateral secretion weight for the diluent challenge was subtracted from that of the antigen challenge to compute this primary outcome measure.|10 minutes post diluent challenge and 10 minutes post antigen challenge|Excludes one patient who did not complete the second crossover intervention.||milligrams||Full Range|Median
122815|NCT00618371|Secondary|Proviral DNA Response, HIV-1 Sequence Variation Levels of Cell Associated HIV DNA and Genetic Variation in HIV During Raltegravir Addition in Individuals Who Have Declines in HIV|We planned to compare HIV DNA levels and HIV genetic variation in individuals with and without ≥10 fold decreases in HIV RNA. As none of the patients had a decline in viral RNA, this analysis could not be readily analyzed|4 weeks|0 participants were analyzed because no patients had ≥10 fold decrease in viral RNA. As described in patient outcome description, we would sequence patients only if a ≥10- fold decrease in viremia occurred, Since no one experienced ≥10 fold decrease in viremia, no sequencing could be performed.|||||
122816|NCT00618371|Primary|Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load|HIV RNA levels were determined with a non-commercial, sensitive single copy assay for HIV. The primary outcome measure was to determine the number of individuals with ≥10fold decrease in HIV RNA|4 weeks|Number of participants based on estimates of how many will have decreased viral RNA levels. If 10 participants do not have decreased RNA, the number of patients with potential for decrease is <15% of all suppressed patients.||participants|||Number
122817|NCT00618332|Secondary|Changes in RQLQ: Eye|The RQLQ eye range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
122818|NCT00618332|Secondary|Changes in RQLQ: Emotional|The RQLQ emotional range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|There were one patient in the Mometasone Furoate group with a missing value.||units on a scale||Standard Deviation|Mean
122819|NCT00618332|Secondary|Changes in RQLQ: Nasal|The RQLQ nasal range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
122820|NCT00618332|Secondary|Changes in RQLQ: Practical|The RQLQ practical range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
122821|NCT00618332|Secondary|Changes in RQLQ: Non-Nasal/Eye|The RQLQ non-nasal/eye range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
122822|NCT00618332|Secondary|Changes in RQLQ: Sleep|The RQLQ sleep range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
122823|NCT00618332|Secondary|Changes in RQLQ: Activity|The RQLQ activity range: 0–6. Higher scores indicate a worse quality of life.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
122853|NCT00617903|Secondary|Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Scores on a scale||Standard Deviation|Mean
122824|NCT00618332|Secondary|Changes in RQLQ: Overall|The RQLQ is a disease-specific measure of a patient’s quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0–6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.|Baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
122825|NCT00618332|Primary|Global Assessment|"Global Assessment: 3=significantly improved, 2=moderately improved,~1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse"|at week 2|There were one patient in the Mometasone Furoate group and two patients in the Placebo group with missing values.||units on a scale||Standard Deviation|Mean
122826|NCT00618072|Secondary|Adiponectin|Total adiponectin was measured with a commercial ELISA kit (Millipore/Linco Research, St. Charles, MO) in the laboratory of Dr. Philipp Scherer.|6 months|||ug/mL||Standard Error|Mean
122827|NCT00618072|Secondary|Triglycerides|Triglycerides were measured by enzymatic immunoassay on an AU400 chemistry auto-analyzer with commercially available enzymatic reagents.|6 months|||mg/dl||Standard Error|Mean
122828|NCT00618072|Secondary|HDL|HDL was measured using two reagents homogeneous systems with selective detergents to homogenize the lipoprotein of interest.|6 months|||mg/dl||Standard Error|Mean
122829|NCT00618072|Secondary|Diastolic BP|Blood pressure was assessed using NCEP guidelines.|6 months|||mmHg||Standard Error|Mean
122830|NCT00618072|Secondary|Systolic BP|Blood pressure was assessed using NCEP guidelines.|6 months|||mmHg||Standard Error|Mean
122831|NCT00618072|Secondary|Waist Circumference||6 months|||cm||Standard Error|Mean
122832|NCT00618072|Secondary|HOMA-IR|HOMA-IR was calculated by the formula: fasting insulin (uU/mL) times fasting glucose (mg/L) divided by 22.5.|6 months|||HOMA-IR score||Standard Error|Mean
122833|NCT00618072|Secondary|Body Weight|Body weight measurement was performed three times and averaged by a single study coordinator.|6 months|||kg||Standard Error|Mean
122834|NCT00618072|Primary|Fasting Insulin|Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin.|6 months|The final data-set consisted of 44 study participants, after exclusion of two study completers due to clinical conditions which appeared de novo (asthma requiring high dose prednisone and growth hormone deficiency diagnosed mid-study) - applicable to all study outcomes.||uIU/mL||Standard Error|Mean
122835|NCT00617929|Secondary|Acute Graft-vs-host Disease|"Percent of patients with Acute Graft-vs-host Disease - a process where T-cells present in the donor's bone marrow at the time of transplant identify the transplant patient as non-self' and attack the patient's skin, liver, stomach, and/or intestines."|Day 30-100|||percentage of participants|||Number
122836|NCT00617929|Secondary|Chimerism|Occurrence of genetically distinct cell types in a single organism|Day 28 post transplantation|||percentage of donor cells||Full Range|Median
122837|NCT00617929|Secondary|Survival|Percent of patients alive from beginning of study to one year post transplantation|One year post transplantation|||percentage of participants|||Number
122838|NCT00617929|Secondary|Time to Primary Neutrophil Engraftment|Time to primary neutrophil engraftment is defined as the percent of patients with an absolute neutrophil count (ANC) of 500 or more neutrophils in a cubic millimeter of blood.|Day 42 post transplantation|||percentage of participants|||Number
122839|NCT00617929|Secondary|Treatment-related Death|Percent of patients who died related to the treatment in this study.|Day 100 post transplantation|||percentage of participants|||Number
122840|NCT00617929|Primary|Survival at 100 Days Post Transplant|Percent of patients alive from beginning of study to Day 100 post transplantation|Day 100 post transplantation|||percentage of participants|||Number
122841|NCT00617929|Primary|Rate of Sustained Donor Engraftment|Rate of Sustained Donor Engraftment is defined as the percent of paticipants with an absolute neutrophile count (ANC) of 500 or more without a subsequent graft rejection.|Day 42 post transplantation|||percentage of participants|||Number
122842|NCT00617903|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)||At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
122843|NCT00617903|Secondary|Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12||At Weeks 4, 8 and 12|||Percentage of participants|||Number
122844|NCT00617903|Secondary|Patients’ Opinion on Cosmetic Acceptability at End of Study|Patient’s opinion on cosmetic acceptability: 1 - very good; 2 – good; 3 – satisfactory; 4 – poor; 5 - no opinion|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases||Percentage of participants|||Number
122845|NCT00617903|Secondary|Patients’ Rating of Overall Improvement at End of Study|Patient’s rating of overall improvement: 1 – excellent; 2 – good; 3 – fair; 4 - no improvement; 5 – worse|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases||Percentage of participants|||Number
122846|NCT00617903|Secondary|Investigator’s Rating of Overall Improvement at End of Study|Investigator’s rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 – deterioration|At End of Study (Week 12)|All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)||Percentage of participants|||Number
122847|NCT00617903|Secondary|Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
122848|NCT00617903|Secondary|Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Scores on a scale||Standard Deviation|Mean
122849|NCT00617903|Secondary|Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)|Telangiectasia intensity score: 1 – None; 2 – Mild; 3 – Moderate; 4 - Severe|At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
122854|NCT00617903|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of participants|||Number
122855|NCT00617903|Secondary|Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||Baseline and Weeks 4, 8, 12 and End of Study (LOCF)|||Percentage of Inflammatory lesions||Standard Deviation|Mean
122856|NCT00617903|Secondary|Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12||Baseline and Weeks 4, 8 and 12|||Inflammatory lesions||Standard Deviation|Mean
122857|NCT00617903|Secondary|Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)||At Weeks 4, 8, 12 and End of Study (LOCF)|||Inflammatory lesions||Standard Deviation|Mean
122858|NCT00617903|Primary|Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)|Erythema intensity score: 1 – Clear or almost clear; 2 – Mild; 3 – Moderate; 4 - Severe|Baseline and End of Study (Week 12)|||Percentage of participants|||Number
122859|NCT00617903|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).|At End of Study (Week 12)|||Percentage of participants|||Number
122860|NCT00617903|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)||Baseline and End of Study (Week 12)|||Inflammatory lesions||Standard Deviation|Mean
122861|NCT00617890|Secondary|Duration of Response (Groups 2 and 3 Only)|This is a measure of the amount of time in which the tumor responded to therapy.|From time of documented response until disease progression or data analysis cut off (Up to 3.4 years)|Group 2 and 3 participants; this outcome was not evaluated due to early termination of the study|||||
122862|NCT00617890|Secondary|Overall Survival (Groups 2 and 3 Only)|This is a measure of the time of survival from first dose to documentation of death|From start of treatment until death or data analysis cut off (Up to 3.4 years)|Group 2 and 3 Participants||Months||95% Confidence Interval|Median
122863|NCT00617890|Secondary|Time to Disease Progression (Groups 2 and 3 Only)|This is a measure of the time from the start of the study to the time of documented disease progression.|From the start of treatment until disease progression or data analysis cut off (Up to 3.4 years)|All participants in Groups 2 and 3; this outcome was not evaluated due to early termination of the study|||||
122864|NCT00617890|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Treatment-emergent adverse events are those that occur after participants have received study treatment, or existing adverse events that occurred during screening that increase in severity after study treatment. Adverse events in the Group 1: 0.3 mg/kg arm that occurred after switching to the 10 mg/kg dose are displayed under the originally assigned treatment.|Up to 2 years|All participants receiving study drug.||Participants|||Number
122865|NCT00617890|Secondary|Incidence of Anti-robatumumab Antibodies|For biological agents, it is possible for the host (participant) to develop antibodies to the agent. This outcome measure was planned to find out the number of participants who developed the antibodies after treatment with robatumumab.|Up to 2 years|This outcome was not evaluated due to early termination of the study.|||||
122866|NCT00617890|Secondary|Area Under the Concentration-time Curve (AUC) of Serum Levels of Robatumumab (Group 1 Only)||End of infusion on Day 1, and then prior to surgery, before and after the 2nd, 3rd, and 8th doses (up to 20 weeks)|Group 1, both dose levels: this outcome was not evaluated due to early termination of the study.|||||
122867|NCT00617890|Secondary|Time Until Tumor Relapse (Group 1 Only)|This is a measure of the time from the start of the study to documented relapse of disease.|From start of treatment until relapse or data analysis cut off (Up to 3.4 years)|Group 1 participants; this outcome was not evaluated due to early termination of the study.|||||
122868|NCT00617890|Secondary|Overall Survival|This is a measure of the number of participants known to be alive at the time of data analysis for this study.|From start of treatment until death or data analysis cut off (Up to 3.4 years)|All study participants||Participants|||Number
122869|NCT00617890|Primary|Number of Participants Achieving a Complete Response, a Partial Response, or Stable Disease (Group 2 Only)|Responses to treatment (complete response, partial response, or stable disease) confirmed by central review for Participants in Group 2. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Group 2 participants with evaluable data.||Participants|||Number
122870|NCT00617890|Primary|Number of Participants With >= 25% Change in Tumor Proliferation After Exposure to Robatumumab (Group 1 Only)|Tumor proliferation was measured using Ki-67 levels. Ki-67 is nuclear protein associated with cellular proliferation.|Approximately 14 days|Group 1 Participants; this outcome was not evaluated due to early termination of the study.|||||
122871|NCT00617890|Primary|Number of Participants Achieving a Complete Response or Partial Response (Group 3 Only)|This is a measure of the number of participants with a complete response (CR) or partial response (PR) to therapy, confirmed by central review. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria.|Up to 1 year following the start of study therapy|Participants in Group 3 with evaluable data.||Participants|||Number
122872|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain B)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"||percentages of participants||95% Confidence Interval|Mean
122873|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"||percentages of participants||95% Confidence Interval|Mean
122874|NCT00617851|Secondary|Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)|"The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:~the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.~the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%."|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"||percentages of participants||95% Confidence Interval|Mean
122875|NCT00617851|Secondary|Number of Subjects With at Least One Unsolicited Adverse Event|Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).|3 weeks after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.||participants|||Number
122876|NCT00617851|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms|Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.|7 days after vaccination|The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data.||Participants|||Number
122877|NCT00617851|Secondary|Geometric Mean Titers (GMTs), by Vaccine Group and Strain|The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"||titers||95% Confidence Interval|Geometric Mean
122878|NCT00617851|Primary|Geometric Mean Titers (GMTs), by Vaccine Lots|The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.|21 days after vaccination|"The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~received all the relevant doses of vaccine correctly, and~provided evaluable serum samples at the relevant time points, and~had no major protocol deviation"||Titers||95% Confidence Interval|Geometric Mean
122879|NCT00617773|Post-Hoc|Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease and ascites at baseline were considered for this analysis.||weeks||95% Confidence Interval|Median
122880|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Visceral Disease at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease at baseline were considered for this analysis.||weeks||95% Confidence Interval|Median
122881|NCT00617773|Post-Hoc|Progression Free Survival in Patients With and Without Ascites at Baseline|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||weeks||95% Confidence Interval|Median
122882|NCT00617773|Other Pre-specified|12-Month Survival Rate|Rate of patients alive 12 months after starting therapy with the investigational product.|12 months from the start of study treatment.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||percentage of participants||95% Confidence Interval|Number
122883|NCT00617773|Other Pre-specified|Overall Survival|Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.|From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||weeks||Full Range|Median
122911|NCT00617604|Secondary|Change From Month 1 in Serum Creatinine||Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by n)."||µmol/L||Standard Deviation|Mean
122884|NCT00617773|Other Pre-specified|Progression Free Survival (PFS)|Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.|From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks.|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.||weeks||Full Range|Median
122885|NCT00617773|Other Pre-specified|Clinical Benefit|"The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown.~Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population.~The evaluation of target and non-target lesions is described at the Outcome Measure titled Best Overall Response. CR: Complete Response; PR: Partial Response; SD: Stable Disease."|From start of study treatment until the end of Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.||percentage of participants||95% Confidence Interval|Number
122886|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses|Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.|All patients enrolled in the study that received at least 8 doses of investigational product were considered to this analysis.||µg/mL||Standard Deviation|Mean
122887|NCT00617773|Secondary|Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.|Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.|Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.|All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.||µg/mL||Standard Deviation|Mean
122888|NCT00617773|Secondary|Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).|Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.|From the first dose of investigational product up to 30 days after the last dose of investigational product|||participants|||Number
122889|NCT00617773|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|A listing of all adverse events is located in the Reported Adverse Event module.|From the first dose of investigational product up to 30 days after the last dose of investigational product|All patients enrolled in the study that received at least 1 dose of investigational product were considered for safety evaluation.||participants|||Number
122890|NCT00617773|Primary|Best Overall Response|"Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).~Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).|All patients enrolled in the study that received at least 4 doses of investigational product were considered to the efficacy evaluation.||participants|||Number
122891|NCT00617708|Primary|Progression-Free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.||months||95% Confidence Interval|Median
122892|NCT00617708|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
122893|NCT00617708|Secondary|Response|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients in the Phase II portion of the study with measurable disease and adequate response assessment.||percentage of participants||95% Confidence Interval|Number
122894|NCT00617708|Primary|Maximum Tolerated Dose Determination|Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|28 days|Phase I patients receiving at least three doses of the assigned dose during Cycle 1 or whom developed a DLT.||mg/kg IMC-A12|||Number
122895|NCT00617708|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients in the Phase II portion of the study.||months||95% Confidence Interval|Median
124254|NCT00605267|Secondary|Serum Oestradiol (E2) Concentrations|Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment|||Ratio||Standard Deviation|Mean
122896|NCT00617669|Secondary|PSA Response|PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Participants|||Number
122897|NCT00617669|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Months||Inter-Quartile Range|Median
122898|NCT00617669|Secondary|Pain Response|Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.||Participants|||Number
122899|NCT00617669|Secondary|Time to Pain Progression|Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Months||Inter-Quartile Range|Median
122900|NCT00617669|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|||Months||Inter-Quartile Range|Median
122901|NCT00617669|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.|While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)|Full Analysis Set||Months||Inter-Quartile Range|Median
122902|NCT00617669|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline|Patients were followed for progression up to 40 months|Full Analysis Set||Months||Inter-Quartile Range|Median
122903|NCT00617669|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 40 months|Full Analysis Set||Months||Inter-Quartile Range|Median
122904|NCT00617604|Secondary|Number of Participants With Adverse Events|"Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.~A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:~Resulted in death.~Was life-threatening.~Resulted in persistent or significant disability/incapacity.~Resulted in congenital anomaly or birth defect.~Required patient hospitalization or led to prolongation of hospitalization~Was considered a medically important event.~All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE"|6 Months|Safety analysis set (all randomized participants who received at least one dose of study drug).||participants|||Number
122905|NCT00617604|Secondary|Percentage of Participants With Treatment Failure at Month 6|Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122906|NCT00617604|Secondary|Percentage of Participants With Delayed Graft Function|Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.|1 week|Full analysis set||percentage of participants|||Number
122907|NCT00617604|Secondary|Percentage of Participants With Efficacy Failure at Month 6|"Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.~The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122908|NCT00617604|Secondary|GFR Measured by Iothalamate Clearance at Month 6|GFR measured using the iothalamate clearance method and determined by a central laboratory.|Month 6|Full analysis set participants with available data||mL/minute||Standard Deviation|Mean
122909|NCT00617604|Secondary|Change From Month 1 in Creatinine Clearance|The creatinine clearance was calculated according to the Cockcroft-Gault formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by n)."||mL/minute||Standard Deviation|Mean
122910|NCT00617604|Secondary|Change From Month 1 in Glomerular Filtration Rate (GFR)|The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Month 1, 3, and 6|"Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by n)."||mL/min/1.73 m²||Standard Deviation|Mean
122912|NCT00617604|Secondary|Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6|The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122913|NCT00617604|Secondary|Maximum Histological Grade of All Biopsies After Local Review|"The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.~Acute T-cell mediated rejection:~Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;~Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;~Grade IIA: mild to moderate intimal arteritis;~Grade IIB: severe intimal arteritis comprising >25% of the luminal area;~Grade III: “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.~Acute antibody-mediated rejection:~Grade I: acute tubular necrosis-like – complement split product positive (C4d+), minimal inflammation;~Grade II: capillary-margination and/or thromboses, C4d+~Grade III: arterial – v3, C4d+."|6 months|Full analysis set||percentage of participants|||Number
122914|NCT00617604|Secondary|Graft Survival|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.~The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122915|NCT00617604|Secondary|Patient Survival|Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122916|NCT00617604|Secondary|Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6|"Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122917|NCT00617604|Secondary|Percentage of Participants With Steroid-resistant Acute Rejection at Month 6|"A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.~The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122918|NCT00617604|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6|Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122919|NCT00617604|Secondary|Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6|Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122920|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122921|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122951|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|12 Months|||units on a scale||Standard Deviation|Mean
126956|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥15-points at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
122922|NCT00617604|Secondary|Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:~Acute antibody-mediated rejection - documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated):~Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;~Grade II: capillary-margination and/or thromboses, C4d+~Grade III: arterial - v3, C4d+.~A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
122923|NCT00617604|Primary|Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review|"Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:~Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;~Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;~Grade IIA: mild to moderate intimal arteritis;~Grade IIB: severe intimal arteritis comprising >25% of the luminal area;~Grade III: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.~A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.~The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set (all randomized and transplanted participants who received at least 1 dose of study drug)||percentage of participants||90% Confidence Interval|Number
122924|NCT00617591|Secondary|Occurrence of Induction Toxicities|"Tolerability of full dose Revlimid® with full dose Doxil® in combination with reduced schedule dexamethasone was to be assessed during Cycle 1 and at the start of Cycle 2 using, whenever possible, the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0.~Due to increased neutropenia and fatigue, toxicities were reviewed after the first 29 participants were enrolled."|24 Months|First 29 participants with the PLD starting dose of PLD 40 mg/m^2, due to increased neutropenia and fatigue.||percentage of participants|||Number
122925|NCT00617591|Secondary|2 Year Overall Survival (OS) Rate|Percentage of participants with Overall Survival in response to Dd-R in newly diagnosed multiple myeloma patients with active disease. Overall survival is time from study entry to death of any cause.|24 Months|All participants||percentage of participants|||Number
122926|NCT00617591|Secondary|Median Progression Free Survival (PFS) in Months|PFS: Time from study entry to progression/relapse or death from study entry to death of any cause, assessed using International Myeloma Working Group Response Definitions. Progressive Disease (PD): One of the following criteria must be met: a. Increase of 25% or greater in serum M protein (absolute increase greater or equal to 0.5g/dl); b. Increase of 25% or greater in urine M protein (absolute increase greater than 200 mg/24h); c. Increase of 25% or greater in the difference between the involved and uninvolved free light chain (absolute increase greater than 10 mg/dl); d. Increase of 25% or greater in bone marrow plasma cell percentage (absolute percent greater than 5% in case the patient was in CR and 10% otherwise); i.e. Definite development of new bone lesions or soft tissue plasmacytomas, or increase in the size of existing plasmacytomas by greater or equal to 25%. Development of hypercalcemia (serum calcium > 11.5 mg/dl) attributable only to the plasma cell dyscrasia.|24 Months|All participants||months||95% Confidence Interval|Median
122927|NCT00617591|Primary|Percentage of Participants With Very Good Partial Remission (VGPR) or Better|Quality of response: % Complete Response (CR) + Very Good Partial Remission (VGPR) to induction Dd-R as assessed using International Myeloma Working Group Response Definitions. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants||percentage of participants|||Number
122928|NCT00617591|Primary|Overall Response Rate (ORR) - Percentage of Participants With Partial Response or Better With Induction Regimen|ORR assessed using International Myeloma Working Group Response Definitions. Partial Remission (PR): A greater than 50% reduction in the serum paraprotein, and if present, a greater than 90% reduction in the urine M protein excretion. Patients must also have a decrease by 50% in the size of soft tissue plasmacytoma. If serum and urine M protein are not measurable, a 50% or greater decreased in the difference of the involved and uninvolved free light chain. Very Good Partial Remission (VGPR): Detectable serum and urine M component on immunofixation but not on electrophoresis or 90% or greater reduction in serum M protein with less than 100 mg/24 h of urinary M protein. Complete Remission (CR): The presence of less than 5% bone marrow plasmacytosis and the disappearance of all evidence of serum and urine M-components on electrophoresis as well as by immunofixation. In addition, soft tissue plasmacytoma must have disappeared.|24 Months|All participants||percentage of participants|||Number
122929|NCT00617461|Secondary|Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations|Steady-state average (Cave, ss), maximum (Cmax, ss), and minimum (Cmin,ss) plasma concentration of gabapentin in each participant were estimated using the gabapentin plasma concentration data and with the aid of a population pharmacokinetic model. Dispersion is represented by the fifth to ninety-fifth percentile, though labeled as “Full Range.” A total of 10 blood samples were collected per participant over the Baseline, Period 1, and Period 2 at various timepoints during the dosing interval. Plasma concentration of gabapentin in these samples was measured.|A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period|Drug concentration data were available from 89 ITT Population participants. Data from 7 of these participants had one concentration with less than half of the first percentile of the concentrations observed at ss and were defined as non-compliant and were excluded from the pharmacokinetic (PK) analysis.||micrograms per milliliter||Full Range|Geometric Mean
124255|NCT00605267|Secondary|Serum Oestrone (E1) Concentrations|Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.|Assessed at baseline and after 24 weeks of treatment|||Ratio||Standard Deviation|Mean
122930|NCT00617461|Secondary|Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF|The BPI assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact to 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where scores range from 0 to 10 (0=no impact to 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of treatment)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and could thus not be included in the analysis.||points on a scale||Standard Error|Least Squares Mean
122931|NCT00617461|Secondary|Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data|Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for sleep interference during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122932|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response data to this questionnaire and could thus not be included in the analysis.||participants|||Number
122933|NCT00617461|Secondary|Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data|"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants without a response to this questionnaire and thus could not be included in the analysis.||participants|||Number
122934|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. Data are summarized by dose within each treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.||participants|||Number
122935|NCT00617461|Secondary|Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved Data are summarized by dose, independent of treatment period."|End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.||participants|||Number
122936|NCT00617461|Secondary|Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period|Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commercial Tylenol) during treatment and multiplying that by 500 mg. Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for rescue medication usage during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||milligrams||Standard Error|Least Squares Mean
122963|NCT00617305|Secondary|Change From Baseline in Six Minute Walk Distance (6MWD) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. An increase in measurement value (meters walked) indicates improvement for this patient population.|Baseline to Week 48|All enrolled Population||meters walked||Standard Deviation|Mean
122937|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period|Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the [(end of treatment score minus the baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.||participants|||Number
122938|NCT00617461|Secondary|Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the [(EOT score minus baseline score) divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, there was one participant who did not provide post-baseline data for 24-hour API assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||participants|||Number
122939|NCT00617461|Secondary|Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current morning pain during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122940|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF|Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122941|NCT00617461|Secondary|Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF|Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for night-time pain assessments during the GEn 1200 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122942|NCT00617461|Secondary|Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period."|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for current evening pain during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122964|NCT00617305|Secondary|Change From Baseline in Cardiac Output (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. An increase in measurement value (L/min) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||L/min||Standard Deviation|Mean
122943|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122944|NCT00617461|Secondary|Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data|Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for day-time pain assessments during the GEn 3600 mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122945|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. The by period summary is provided as a sensitivity analysis for the primary analysis.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24 hour API while taking GEn 3600 mg in the first period, and was therefore not included in this analysis.||points on a scale||Standard Deviation|Mean
122946|NCT00617461|Primary|Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data|Baseline and end of treatment values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (baseline) and the last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as end of treatment minus baseline. Data are summarized by dose, independent of treatment period.|Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)|Of the 93 participants in the ITT Population, there were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. In addition, 1 participant did not provide post-baseline data for 24-hour API assessments during the GEn 3600mg treatment period, and was therefore not included in this analysis.||points on a scale||Standard Error|Least Squares Mean
122947|NCT00617409|Secondary|Overall Survival (OS)|To evaluate the survival of all patients enrolled on an intent-to-treat basis. Overall survival per treatment arm.|Up to 24 months|All participants.||months||95% Confidence Interval|Median
122948|NCT00617409|Primary|Tumor Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started. PD: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|12 months|All participants.||participants|||Number
122949|NCT00617396|Primary|Adequate Relief in Pain Score During Treatment|"Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.-  Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain."|8 weeks|There was no exact statistical test used to determine the sample size. It is based on the capacity of site to recruit subjects.||percentage of subjects|||Number
122950|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|24 Months|||units on a scale||Standard Deviation|Mean
124256|NCT00605267|Secondary|Bone Turnover Marker (NTX)|Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks|Assessed at baseline and after 24 weeks of treatment|||nmolBCE(Bone Collagen Equivalent) /L||Standard Deviation|Mean
122952|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|6 Months|||units on a scale||Standard Deviation|Mean
122953|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|3 Months|||units on a scale||Standard Deviation|Mean
122954|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are transformed to produce a range of 0–100, with higher values indicating greater functional activity.|30 Days|||units on a scale||Standard Deviation|Mean
122955|NCT00617357|Secondary|Activities Assessment Scale (AAS)|The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from “No difficulty” to “Not able to do it.” The AAS has three subscales: sedentary activities (items 1–4); ambulatory activities (items 6–8); work/exercise activities (items 11–13). The AAS total and subscale scores are numerically transformed to produce a range of 0–100, with higher values indicating greater functional activity.|Baseline|||units on a scale||Standard Deviation|Mean
122956|NCT00617357|Primary|Incidence of Wound Events|Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.|Postoperatively up to 24 months|80 patients were enrolled and received Strattice Reconstructive Tissue Matrix to support the repair and were included in the Intent to Treat (ITT) population.||participants|||Number
122957|NCT00617305|Secondary|Overall Survival, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|Overall survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of death after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Overall Survival||Probability of death occurring (%)||95% Confidence Interval|Number
122958|NCT00617305|Secondary|Time to Clinical Worsening of PAH, Evaluated at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and After Week 48|The time to clinical worsening was defined as the time from enrollment to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, or initiation of chronic parenteral prostanoid therapy. Results are presented as the Kaplan-Meier estimate (% probability) of having clinical worsening after a given time.|Baseline to Week 48+|The Ambrisentan Only and Any Ambrisentan Groups were analyzed for Time to Clinical Worsening||Probability of clinical worsening (%)||95% Confidence Interval|Number
122959|NCT00617305|Secondary|Change From Baseline in Log-transformed N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean percent change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. A decrease in log-transformed measurement value (pg/mL) indicates improvement for this patient population.|Baseline to Week 48|One patient (Any Placebo) was not evaluated for NT-proBNP. One patient (Placebo Only) had no baseline measurement, so no statistical analyses for change from baseline are given for the placebo only group (patient was only subject in this group).||pg/mL (log-transformed)||Standard Deviation|Mean
122960|NCT00617305|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class (LOCF) Measured at Weeks 4, 12, 24, 36 and 48.|The primary analysis of this secondary outcome measure is change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. WHO categories are 1 to 4 with the worst category being 4. Improvement is represented by a change in category to a lower number (for example, change from category 3 to 2), and deterioration is represented by a change in category to a higher number (for example, change from category 2 to 4). No change is represented by no change in category (for example, category 2 which remains 2).|Baseline to Week 48|All enrolled Population||participants|||Number
122961|NCT00617305|Secondary|Change From Baseline in the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life (QOL) Survey Overall Score Measured at Weeks 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 12, 36, and 48 were also evaluated. Lower scores and decreases from baseline represent improved functioning and QOL. The CAMPHOR survey was not assessed at Week 4. The total CAMPHOR score scale ranges from 0 (good) to 25 (poor). A reduction in score over time represents improvement in this patient population.|Baseline to Week 48|All enrolled Population||units on a scale||Standard Deviation|Mean
122962|NCT00617305|Secondary|Change in Dyspnea Index Measured at Weeks 4, 12, 24, 36 and 48 (LOCF)|The primary analysis of this secondary outcome measure is mean change from Baseline to Week 24. The changes from Baseline to Weeks 4, 12, 36, and 48 were also evaluated. The dyspnea index measures the degree of breathlessness after completion of the 6MWT using a scale of 0 to 10, with 0 indicating no breathlessness and 10 indicating maximum breathlessness.|Baseline to Week 48|All enrolled Population||units on a scale||Standard Deviation|Mean
122965|NCT00617305|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||mmHg||Standard Deviation|Mean
122966|NCT00617305|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) (LOCF)|This secondary hemodynamic outcome is supportive of the primary outcome. A decrease in measurement value (mmHg) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||mmHg||Standard Deviation|Mean
122967|NCT00617305|Primary|Change From Baseline in Pulmonary Vascular Resistance (PVR), Last Observation Carried Forward (LOCF)|The primary objective of this study is to evaluate the change from baseline in PVR, and other hemodynamic parameters, following the addition of ambrisentan to background PDE-5i therapy in subjects with PAH who have demonstrated a sub-optimal response to PDE-5i monotherapy. A decrease in measurement value (dynes sec/cm^5) indicates improvement for this patient population.|Baseline to Week 24|Patients with measurements at Baseline and Week 24 were evaluated||dynes sec/cm^5||Standard Deviation|Mean
122968|NCT00617279|Secondary|Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure|The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.|One month|The number of patients analyzed at 1 month does not equal the number of patients originally enrolled into the study, due to the fact that a number of enrolled patients did not have (or failed to attend) their 1 month follow-up visit prior to the termination of the study.||scores on a scale||Standard Deviation|Mean
122969|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months|||Participants|||Number
122970|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months|||Participants|||Number
122971|NCT00617279|Secondary|Number of Patients With Delayed Wound Healing Through One Month Post-procedure|Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month|||Participants|||Number
122972|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 12 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|12 months|||Participants|||Number
122973|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through 6 Months|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|6 months|||Participants|||Number
122974|NCT00617279|Secondary|Number of Patients With Wound/Graft Infection Through One Month Post-procedure|Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.|One month|||Participants|||Number
122975|NCT00617279|Secondary|Number of Patients Surviving at 12 Months||12 months|||Participants|||Number
122976|NCT00617279|Secondary|Number of Patients Surviving at 6 Months||6 months|||Participants|||Number
122977|NCT00617279|Secondary|Number of Patients Surviving at One Month||One month|||Participants|||Number
122978|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 12 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months|||Participants|||Number
122979|NCT00617279|Secondary|Patients Experiencing Major Adverse Events Through 6 Months Post-procedure|A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|6 months|||Participants|||Number
122980|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|12 months|||Participants|||Number
122981|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|6 months|||Participants|||Number
122982|NCT00617279|Secondary|Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure|Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.|One month|||Participants|||Number
122983|NCT00617279|Secondary|Number of Patients With Secondary Patency at 12 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.||Participants|||Number
122984|NCT00617279|Secondary|Number of Patients With Secondary Patency at 6 Months|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.||Participants|||Number
122985|NCT00617279|Secondary|Number of Patients With Secondary Patency at One Month|Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.||Participants|||Number
122986|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 12 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.||Participants|||Number
122987|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at 6 Months Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.||Participants|||Number
122988|NCT00617279|Secondary|Number of Patients With Assisted Primary Patency at One Month Post-procedure|Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.|One month|||Participants|||Number
122989|NCT00617279|Secondary|Number of Patients With Primary Patency at 6 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|6 months|The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.||Participants|||Number
122990|NCT00617279|Primary|Major Adverse Event Occurrences Through One Month Post-procedure|The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.|one month post-index procedure|||Events|||Number
122991|NCT00617279|Secondary|Number of Patients With Primary Patency at One Month Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|One month|The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.||Participants|||Number
122992|NCT00617279|Primary|Number of Patients With Primary Patency at 12 Months Post-procedure|Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.|12 months|The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that many enrolled patients did not have their 12 month follow-up visit prior to the termination of the study.||Participants|||Number
122993|NCT00617240|Secondary|Incidence of Metabolic Syndrome|Metabolic syndrome is a combination of the medical disorders that, when co-occurring, increase the risk of developing cardiovascular disease and diabetes.|24 weeks|||participants|||Number
122994|NCT00617240|Secondary|Change From Baseline to Week 24 in Triglycerides|In the human body, high levels of triglyceride fats in the bloodstream have been linked to atherosclerosis and, by extension, the risk of heart disease and stroke. A change in triglycerides is calculated from 24 weeks minus baseline levels.|24 weeks|Only participants with complete data on triglyceride levels at both baseline and 24 weeks were utilized.||mg/dl||Standard Error|Mean
122995|NCT00617240|Secondary|Change From Baseline to Week 24 in Cholesterol Level|According to the lipid hypothesis, abnormal cholesterol levels are strongly associated with cardiovascular disease because these promote atherosclerosis.Cholesterol levels are measured in milligrams (mg) of cholesterol per deciliter(dL) of blood.Change in cholesterol levels is measured at 24 weeks minus the levels at baseline.|24 weeks|Only participants with complete data on cholesterol levels at both baseline and 24 weeks were utilized.||mg/dl||Standard Error|Mean
122996|NCT00617240|Secondary|Change From Baseline to Week 24 in Insulin Level|Insulin is a peptide hormone and regulates carbohydrate and fat metabolism in the body.Change in Insulin level is calculated as the 24 weeks insulin level minus the baseline insulin level.|24 weeks|Only participants with complete data on insulin levels at both baseline and 24 weeks were utilized.||microIU/ml||Standard Error|Mean
122997|NCT00617240|Primary|Change From Baseline to Week 24 in Fat Mass|Fat mass is a measure of excess body fat. Change in Fat Mass is calculated as 24 weeks fat mass minus the baseline fat mass.|24 weeks|Only participants with complete data on fat mass at both baseline and 24 weeks were utilized.||kg||Standard Error|Mean
122998|NCT00617240|Primary|Change From Baseline to Week 24 in Weight|Change in weight is calculated as 24 weeks weight minus the baseline weight.|24 weeks|||kg||Standard Error|Mean
122999|NCT00617240|Primary|Change From Baseline to Week 24 in Body Mass Index (BMI)|Change in BMI-Body Mass Index (BMI) is a measure of body fat based on height, weight,gender and chronological age. Change in BMI is calculated as 24 weeks BMI minus the baseline BMI.|0-24 weeks|All participants who took at least one dose of study treatment and had at least one post baseline assessment.||kg/m^2||Standard Error|Mean
123000|NCT00617201|Secondary|Retention|Trial retention- those who complete the 12 week dosing period|12-weeks|those completing the 12-week study after randomization||days||Standard Error|Mean
123001|NCT00617201|Primary|% Urine Samples Negative for Cocaine|Total % urine samples negative for benzoylecgonine over the 12-week trial|12 weeks|Initial power analyses- intent-to-treat analysis included all subjects with missing counted as positive with odds ratio||percentage of urine samples negative||95% Confidence Interval|Number
123003|NCT00617188|Primary|Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Day 90|||Participants|||Number
123004|NCT00617188|Secondary|Serum Skeletal-Specific Alkaline Phosphatase Concentration|Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.|Baseline, 1 Month, 3 Months, 6 Months|||Units/Liter||Full Range|Median
123005|NCT00617188|Secondary|Mean Scores - Quality of Life Assessment|Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O)Version 1/23/07 - This is a relative quality of life assessment; 100 = Best, 0 = Worst. It was developed and validated with cancer patients and includes physical well being, social well being, emotional well being and relationship with doctor subscales and can be summed into one total quality of life score. It is a standardized scale which collects data (scores 1-4) from 47 questions. Answers are transformed into a number between 0-100. Mean was calculated by adding up the values of the scores and dividing by the number of scores.|Baseline, 3 Months Post Treatment, 6 Months Post Treatment|||Scores on a Scale||Full Range|Mean
123006|NCT00617188|Secondary|Median Number of Days to Treatment Termination|Time is determined from first dose to termination due to all causes.|Up to 373 Days|||Days||Full Range|Median
123007|NCT00617188|Secondary|Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)|Defined by the sum of Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=normalization of serum CA-125 level from 2 initially elevated samples, PR=>or=50% decrease in serum CA-125 level from 2 initially elevated samples, Progressive Disease (PD)=CA-125 two times the upper limit of normal on 2 occasions (if previously normalized) OR CA-125 two times nadir (lowest value) on 2 occasions if elevated at initiation of treatment, SD=not CR, PR or PD.|Day 90|||Participants|||Number
123008|NCT00617175|Secondary|Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.||end of study||||||
123009|NCT00617175|Primary|For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.|"for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.~The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100."|From enrollment to study completion or exit whichever occured first|For the primary endpoint analysis, only patients with at least a device data record were considered.||rate of therapies per 100 patient-years||95% Confidence Interval|Number
123010|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography|Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment as measured by fundus photogrpahy.||score on a scale||Standard Error|Mean
123011|NCT00617123|Secondary|Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT|Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment by OCT.||score on a scale||Standard Error|Mean
123012|NCT00617123|Secondary|Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT|Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline center point thickness assessment by OCT.||participants|||Number
123013|NCT00617123|Secondary|Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline|Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.|Baseline and 4, 8 and 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline visual acuity score.||participants|||Number
123014|NCT00617123|Primary|Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)|Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).|Up to 12 months|The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline vacuolation assessment.||participants|||Number
123015|NCT00617097|Secondary|Complications||end of study|||participants|||Number
123016|NCT00617097|Secondary|Reported Symptoms|fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)|end of study (upon discharge from facility after procedure)|||participants|||Number
123017|NCT00617097|Secondary|Visual Analogue Scale Regarding Satisfaction Level|100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)|end of study (prior to clinic discharge)|||mm||Standard Deviation|Mean
123018|NCT00617097|Primary|Level of Pain During Specific Time Intervals Throughout D&C Procedure.|"100-mm Visual Analogue Scale (VAS) during specific time intervals of D&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain)~Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure."|Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure|||mm||Standard Deviation|Mean
123019|NCT00617084|Secondary|In-Stent Percent Diameter Stenosis|In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.|13 Months|||Percentage diameter stenosis||Standard Deviation|Mean
123020|NCT00617084|Primary|Target Lesion Failure|Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.|12 months|Analysis per intention to treat||percentage of participants|||Number
123021|NCT00617058|Secondary|Percent Change in LDL||24 weeks|||percent change|||Number
123022|NCT00617058|Secondary|Percent Change in HDL||24 weeks|||percent change|||Number
123023|NCT00617058|Secondary|Percent Change in Glucose Levels||24 weeks|||percent change|||Number
123024|NCT00617058|Primary|Percent Change in Weight||24 weeks|||percent change|||Number
123025|NCT00617058|Secondary|Incidence of Metabolic Syndrome||24 weeks|||participants|||Number
123026|NCT00617058|Secondary|Percent Change in Triglycerides||24 weeks|||percent change|||Number
123027|NCT00617058|Secondary|Percent Change in Total Cholesterol||24 weeks|||percent change|||Number
123028|NCT00617058|Secondary|Percent Change in Insulin Levels||24 weeks|||percent change|||Number
123029|NCT00617058|Primary|Percent Change in Fat Mass||24 weeks|||percent change|||Number
123030|NCT00617058|Primary|Absolute Change in Weight||24 weeks|||lbs.|||Number
123031|NCT00617058|Primary|Percent Change in BMI||24 weeks|This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures.||percent change|||Number
123032|NCT00616967|Secondary|Baseline and Change in Continuous Variables (e.g., Candidate Gene Methylation, Expression Profiles, Tissue, and Peripheral Blood Mononuclear Cell Histone Acetylation)||Time of breast cancer surgery||||||
123033|NCT00616967|Secondary|Long Term Outcomes||Indefinite survival analysis||||||
123034|NCT00616967|Secondary|Baseline and Change in Markers of Apoptosis and Proliferation||Time of breast cancer surgery||||||
123035|NCT00616967|Secondary|Standard Uptake Values as Measured by Baseline and Changes (Day 15) on FDG-PET|The standard uptake value used for the PET analysis was SULmax, which is the standard uptake value normalized for lean body mass.|Baseline and day 15|"Of the 17 responders from the primary outcome measure, 16 participants had PET data evaluable for analysis. Of the 45 non-responders from the primary outcome measure, 43 participants had PET data evaluable for analysis."||percentage of change in SULmax||Full Range|Median
123036|NCT00616967|Secondary|Clinical Complete Response (cCR) Rate||Time of breast cancer surgery||||||
123037|NCT00616967|Secondary|Safety as Measured by NCI CTCAE Version 3.0||Active treatment until 30 days post-treatment||||||
123038|NCT00616967|Primary|Pathological Complete Response (pCR) Rate|The primary end point was pCR, defined as no viable invasive cancer in breast and axilla. All other cases were defined as non-pCR. The pCR rate was determined in each arm separately by performing an intent-to-treat (ITT) analysis of all randomized patients. Patients with unknown pCR status were considered non-responders. Computation of associated 90% confidence intervals did not account for the sequential design.|Time of breast cancer surgery|"The information for the primary populations for analysis are included (Placebo and Vorinostat arms). The initial run-in phase of 6 participants was conducted to confirm safety and dosing for the combination of vorinostat with chemotherapy only, and these data are not a part of our primary study analyses."||participants|||Number
123039|NCT00616928|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays|Titers were expressed as Geometric Mean Titers (GMTs).|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.||Titers||95% Confidence Interval|Geometric Mean
123040|NCT00616928|Secondary|Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.|Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with available data.||Subjects|||Number
123041|NCT00616928|Secondary|Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables at Month 6.||Titers||95% Confidence Interval|Geometric Mean
123042|NCT00616928|Secondary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)||At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6||Subjects|||Number
123043|NCT00616928|Secondary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Month 6 (Day 182) after Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6||Subjects|||Number
123044|NCT00616928|Secondary|Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10||At Month 6 (Day 182) post Dose 1|The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6||Subjects|||Number
123045|NCT00616928|Secondary|Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10||At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.||Subjects|||Number
123046|NCT00616928|Primary|Number of Subjects With Medically Attended Events (MAEs)||From Day 0 through Day 182 and through Day 364.|||Subjects|||Number
123047|NCT00616928|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 through Day 182 and through Day 379.|||Subjects|||Number
123048|NCT00616928|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)|||Subjects|||Number
123049|NCT00616928|Primary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.||Subjects|||Number
123050|NCT00616928|Primary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration|The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.||Subjects|||Number
123051|NCT00616928|Primary|Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.|At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.||Subjects|||Number
123052|NCT00616928|Primary|Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.|At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)|The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.||Subjects|||Number
123053|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)|Plasma BNP is a product from the heart that becomes elevated with an enlarged heart and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||ng/L||Standard Deviation|Mean
124257|NCT00605267|Secondary|Bone Turnover Marker (BAP) CLEIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method|Assessed at baseline and after 24 weeks of treatment|||ug/L||Standard Deviation|Mean
123054|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks|Plasma high sensitivity CRP is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||mg/L||Standard Deviation|Mean
123055|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks|Plasma IL-6 is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||cm/sec||Standard Deviation|Mean
123056|NCT00616902|Secondary|Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks|Plasma troponin-t is a marker of heart damage and and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||mcg/L||Standard Deviation|Mean
123057|NCT00616902|Secondary|Change From Baseline in Biological Marker Triiodothyronine (T3).|Plasma T3 is a circulating hormone that may have an effect on diastolic heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.|Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)|The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks.||nmol/L||Standard Deviation|Mean
123058|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks|E-wave deceleration time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||sec||Standard Deviation|Mean
123059|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.|The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.|Baseline, Week 24, and Week 48/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||cm/sec||Standard Deviation|Mean
123060|NCT00616902|Secondary|Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.|Isovolumetric relaxation time is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||sec||Standard Deviation|Mean
123061|NCT00616902|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|"Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7.~The primary comparison was between the 4 mcg paricalcitol injection and the placebo treatment groups in the change from baseline to Week 48."|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug and the Evaluable population (a subset of ITT population and consists of those participants who have completed Week 24 visit). None of the participants completed 24 or 48 weeks.||g/m2.7||Standard Deviation|Mean
123062|NCT00616902|Secondary|Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.|Mitral Annular relaxation velocity is a measure of diastolic heart function.|Baseline, 24 Weeks, and 48 Weeks/Early Termination|The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks.||cm/sec||Standard Deviation|Mean
124258|NCT00605267|Secondary|Bone Turnover Marker (BAP) EIA Method|Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method|Assessed at baseline and after 24 weeks of treatment|||U/L||Standard Deviation|Mean
123063|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 6 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 6 or more segments matched the segments at baseline and at 2 years.||mm/year||Standard Error|Mean
123064|NCT00616772|Secondary|Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.||mm/year||Standard Error|Mean
123065|NCT00616772|Secondary|Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)|Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years.||mm/year||Standard Error|Mean
123066|NCT00616772|Secondary|Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter.||mm/year||Standard Error|Mean
123067|NCT00616772|Primary|Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)|Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.|Baseline, 6 months, 12 months, 18 months, and 24 months|All randomized participants who had both a baseline value and at least 1 postbaseline value for that parameter.||mm/year||Standard Error|Mean
123068|NCT00616759|Primary|Wechsler Memory Scale-III (WMS-III) Auditory Delayed Index|WMS-III Auditory Delayed Index is a measure of memory functioning. The results given are the post-ECT testing results. A smaller number indicates less memory disturbance on this scale. The range of scores is between 0-140 with higher scores indicating better memory function.|Pre-tesing within 36 hours before first ECT; Post-testing within 36 hours of 6th ECT.|The measurements listed are post-ECT testing for both groups||units on a scale||Standard Deviation|Mean
123069|NCT00616759|Secondary|California Verbal Learning Test (CVLT)|CVLT consists of a number of individual subtests of various aspects of memory. Higher scores indicate better memory function.|Within one week pre-ECT and within 48 hours after the 6th ECT||||||
123070|NCT00616655|Secondary|Change From Baseline Epworth Sleepiness Scale (ESS)|ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
123071|NCT00616655|Secondary|Change From Baseline Sheehan Disability Scale (SDS)|The SDS was completed by the subject and captured the subject’s level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
123072|NCT00616655|Secondary|Change From Baseline Insomnia Severity Index (ISI) Total Score|The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.|Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
123073|NCT00616655|Secondary|Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form|The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum [item 1... item 14]-14)/(70-14 ) *100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
123074|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) Remission|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less.~The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||participants|||Number
123075|NCT00616655|Secondary|Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response|"The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score.~The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms."|Week 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||participants|||Number
123076|NCT00616655|Secondary|Clinical Global Impression- Improvement (CGI-I)|"CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, Compared to his/her condition at Visit 2, how much has he/she changed? The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement."|Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
123077|NCT00616655|Secondary|Change From Baseline in Clinician Global Impression of Severity (CGI-S)|"The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, Considering your total clinical experience with this particular population, how anxious is the subject at this time? The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity."|Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
123078|NCT00616655|Secondary|Change in Individual Item Scores on HAM-A|The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.|Baseline, Weeks 2, 4, 6, 8|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||units on a scale||Standard Deviation|Mean
123079|NCT00616655|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)|The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)|ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.||unit on a scale||Standard Deviation|Mean
123080|NCT00616655|Primary|Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater|THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.|Baseline to Week 8|ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period.||Units on a scale||Standard Deviation|Mean
123081|NCT00616642|Primary|Efficacy of Rosiglitazone Maleate on Cushing Disease|Reduction in pituitary tumor volume by over 50% as assessed by MRI to measurements made at baseline.|12 months|No data was analyzed for this outcome measure as there was insufficient data to perform analysis.|||||
123082|NCT00616629|Secondary|Number of Patients Who Had at Least One AE|Number of patients|During active treatment period|||Participants|||Number
123083|NCT00616629|Secondary|AUC Total of AZD1305 (Umol*h/L)|A total of 13 scheduled PK samples for each patient during and after infusion|Based on PK samples during and after infusion|||umol*h/L||Full Range|Mean
123084|NCT00616629|Secondary|Cmax Observed for AZD1305|A total of 13 scheduled PK samples for each patient during and after infusion|During and after infusion|||umol/L||Full Range|Mean
123085|NCT00616629|Secondary|QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia’ Formula =QT/RR1/3 Interval in Seconds)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona|||ms||Full Range|Mean
123086|NCT00616629|Secondary|VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product|||ms||Full Range|Mean
123087|NCT00616629|Secondary|RAERP (Right Atrial Effective Refractory Period)|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product|||ms||Full Range|Mean
123088|NCT00616629|Primary|LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))|Absolute change, after - before infusion|Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product|||ms||Full Range|Mean
123089|NCT00616603|Primary|Duration of Sciatic Nerve Block|Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores|from the time the block was placed up to 24 hours|PI left the institution and no analysis completed due to questionable data integrity|||||
123090|NCT00616577|Primary|Usage of Pain Medications||Over 24 hours|PI left institution and records cannot be located.|||||
123091|NCT00616434|Secondary|Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8|The SCCAI measures disease activity as defined by both participants and examiners and includes the following 13 items: general well-being, abdominal pain, bowel frequency, stool consistency, bleeding, anorexia, nausea or vomiting, abdominal tenderness, extra-intestinal complications (eye, mouth, joint, skin), temperature, sigmoidoscopic assessment, nocturnal bowel movements, and urgency of defecation. Scores range from 0 to 19 points, and scores <2.5 have been shown to correlate with Patient-Defined Remission, and a decrease of >1.5 points from Baseline correlates with Patient-Defined Significant Improvement. Baseline is defined as the mean of the screening and visit 1 scores.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline SCCAI ≥ 3 was available.||percentage of participants|||Number
123092|NCT00616434|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE, can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AE’s were analyzed based on the principle of treatment emergence. An AE was regarded as treatment-emergent if it was not present prior to receiving the first injection but subsequently appeared, or if it was present prior to receiving the first injection and subsequently worsened in severity.|Up to 16 weeks|Safety Population; participants who were randomized and received at least one dose of study treatment.||participants|||Number
123093|NCT00616434|Primary|Percentage of Participants With a Clinical Response|Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.|Baseline and Week 8|Intent-to-treat (ITT): Defined as all randomized participants who received at least one dose of study treatment for whom a baseline measure was available.||percentage of participants|||Number
123223|NCT00615108|Secondary|Percentage of Patients Achieving BP Response|Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.||percentage of participants|||Number
123094|NCT00616421|Secondary|Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.|day 1 to study termination (day 240)|The analysis was performed on safety population. Only groups receiving 1 dose vaccine are reported.||Percentage of Subjects|||Number
123095|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.||Percenatage of subjects|||Number
123096|NCT00616421|Secondary|Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.|Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.|Study days 1 to 7|The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.||Percentages of subjects|||Number
123097|NCT00616421|Secondary|GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y.~ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
123098|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
123099|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)|"The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
123100|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
123101|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
123102|NCT00616421|Secondary|Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.|The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
123103|NCT00616421|Secondary|Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
123104|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
123128|NCT00615992|Secondary|Global Assessment of Tolerability by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
126957|NCT00578812|Secondary|Clinically Significant Improvement on Neck Disability Index (NDI)|Improvement in NDI of ≥20% at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
123105|NCT00616421|Secondary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percenatage of subjects||95% Confidence Interval|Number
123106|NCT00616421|Primary|Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age|"The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.~Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
123107|NCT00616343|Primary|Tremor Severity|PI has left the institution and we are unable to accurately assess the data from the remaining records.|4 weeks||||||
123108|NCT00616239|Secondary|Improvement of Melasma Based on MASI Scores, Melasma Severity Assessment, and Physician and Patient Global Improvement Compared With the Opposite Side.||14 weeks||||||
123109|NCT00616239|Primary|Number of Participants Showing Improvement of Melasma Based on Mexameter Readings|The degree of participants pigmentation was measured from the affected and unaffected skin on both sides of the face using a narrowband reflectance spectrophotometer.|14 weeks|||participants|||Number
123110|NCT00614198|Secondary|Changes to Appearance of Multiple Compounds in Urine Samples||Baseline - 8 months -12 months - 24 months||||||
123111|NCT00614198|Primary|Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement.|ADOS (Autism Diagnostic Observation Schedule): module 1 cutoff scores (communication+social): autism=12, autism spectrum (AS)=7; module 2 cutoffs: autism=12, AS=8; module 3 cutoffs: autism=10; AS=7. GARS (Gilliam Autism Rating Scale): <80 low probability of autism, 81-90 below average, 91-110 average, >110 above average probability of autism. VABS (Vineland Adaptive Behaviour Scale): <69 (low ability), 70-84 (moderate/low), 85-115 (adequate), 116-130 (moderate/high), >130 (high). ADHD-IV: 0=no problems indicated. >11 attention & >11 hyperactivity = ADHD diagnosis.|Baseline - 8 months - 12 months - 24 months|Per protocol analysis. Analysis was conducted on n=26 (Gluten- and casein-free dietary intervention) and n=29 (No gluten- and casein-free dietary intervention) at 12 months. Analysis was conducted on n=18 and n=17 at 24 months (both on gluten- and casein-free dietary intervention).||Units on a scale||Standard Error|Mean
123112|NCT00616200|Secondary|Sickness Impact Profile|Units of measurement on the Sickness Impact Profile were ordinal rated scored. Information on scoring use and interpretation of the Sickness Impact Profile, readers are encouraged to read Bergner et. al. 1981 - Bergner, M., Bobbit, R.A., Carter, W.B. et all (1981) the Sickness Impact Profile: Development and final revision of a health status measure. Medical Care, 19:787-805 The SIP measures sickness-related dysfunction based on behavior in order to provide a measure of health status that will aid in assessing the outcome of health care services.|At the end of four week VLCD|The scoring range is from no impairment with a score of 0, to significant impairment, with 5. Changes in score of 3.5 are considered clinically significant.||Scores on a scale||Standard Deviation|Mean
123113|NCT00616200|Secondary|Impact of Very Low Carbohydrate Diet on Stool Frequency|Stool Frequency was measured as number of stools per day|6 Weeks|Analysis was per protocol analysis||Stools Per day||Standard Deviation|Mean
123114|NCT00616200|Primary|"Number of Subjects Reporting Adequate Relief From IBS Symptoms for the Previous Week. Adequate Relief Was a True/False Item."|"Adequate relief was measured as the primary endpoint via a single item Adequate Relief Question asking Over the past week have you had adequate relief of your symptom experience. Higher scores represent greater levels of adequate relief over the week prior to the assessment. Participants completed this 1-item questionnaire at the end of each of weeks of the study, assessing whether they had adequate relief of their IBS symptoms for the week.~A responder was defined as reporting adequate relief in at least 2 of the 4 weeks on the VLCD."|At the end of each of 6 study weeks|||Participants|||Number
123115|NCT00616122|Secondary|Correlation of Outcome Measures With Possible Surrogate Markers Including Serial Measurements of Circulating Tumor Cells and Circulating Endothelial Cells||until disease progression up to 13 months post treatment||||||
123116|NCT00616122|Secondary|Duration of Response|duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer).|until disease progression up to 13 months post treatment|A partial response was only reported for one patient, while a complete response was not recorded for any patients.||weeks|||Number
123129|NCT00615992|Secondary|Global Assessment of Efficacy by Patient|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
123130|NCT00615992|Secondary|Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||points on a scale||Standard Deviation|Mean
123117|NCT00616122|Secondary|Response|"Per Response Evaluation Criteria in Solid Tumors (RECIST):~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)."|until disease progression up to 13 months post treatment|||participants|||Number
123118|NCT00616122|Primary|PFS Greater Than or Equal to 12 Weeks (Phase II)|"Per Response Evaluation Criteria in Solid Tumors (RECIST):~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer)."|12 weeks|Patients who received either 25mg or 37.5mg of sunitinib and were not removed from study due to voluntary withdrawal or POD prior to receiving combination sunitinib and metronomic CM chemotherapy.||participants|||Number
123119|NCT00616122|Primary|Maximum Tolerated Dose (Phase I)|"Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level.~Dose limiting toxicity (DLT):~≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days~grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 ºC or 3 readings of oral temperature > 38.0 ºC in a 24 hour period)~≥ grade 3 thrombocytopenia~≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment.~Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity."|8 weeks|||mg|||Number
123120|NCT00616109|Secondary|Number of Patients That Discontinue Drug Due to Toxicity|"Tolerability of Sunitinib will be evaluated by looking at the number of participants who discontinue drug due to toxicity. Toxicity was graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v.3.0.~In the event of any CTC, version 3.0 drug-related grade 3 or 4 non-hematologic or grade 4 hematologic adverse event(s), drug should be held until the toxicity resolves to < grade 1 and then the drug should be restarted at a one dose-level reduction.~Recovery to acceptable levels of toxicity must occur within 4 weeks to allow continuation in the study.~No more than 2 dose reductions are permitted for any patient. If further dose reduction is required, the patient must be removed from the study."|20 weeks|All patients who received sunitinib maintenance therapy were evaluable for toxicity and tolerability analysis.||participants|||Number
123121|NCT00616109|Secondary|Percent of Patients With an Objective Response|Scans were performed every 2 cycles to evaluate for response/progression. Response was assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Patients would be considered to have an objective response if they experience CR (Complete Response - Disappearance of all clinical and radiological evidence of target lesions and/or non-target lesions) or PR (Partial Response - A 30% or greater decrease in the sum of LD of all lesions in reference to the baseline sum LD).|12 weeks (2 cycles)|Patients who received at least 2 cycles of study therapy (maintenance sunitinib)||percentage of participants|||Number
123122|NCT00616109|Secondary|Median Overall Survival|Survival will be defined as the time from the first day of therapy to the date of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. Survival for induction therapy will be calculated from day 1 of first cycle of chemotherapy. Survival for post-induction therapy will be calculated from the date the patient starts sunitinib.|up to 4 months post treatment|15 participants in Sunitinib maintenance therapy (main study) were enrolled and were evaluable for this outcome measure. Although 16 patients were enrolled, one patient opted to discontinue therapy, refused further follow-up, and was therefore censored from survival analysis.||months||95% Confidence Interval|Median
123123|NCT00616109|Primary|Progression Free Survival Rate|The proportion of patients who are progression-free at 4 months after starting sunitinib.|4 Months Post Treatment|All 16 patients enrolled received a median of 4 weeks sunitinib maintenance therapy. 1 patient who discontinued requested no follow up and was censored from survival analysis. All survival endpoints were analyzed using the Kaplan-Meier method (Kaplan El, Meier P, Non-parametric Estimation from Incomplete Observations, J Am Stat Association, 1958)||percentage of patients with PFS||95% Confidence Interval|Number
123124|NCT00616018|Secondary|Alanine Aminotransferase (ALT)|ALT was measured at Day 0, 4, 7, 9, 11, and 14.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.||IU/L||Standard Deviation|Mean
123125|NCT00616018|Primary|Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts|Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.|Day 0, 4, 7, 9, 11, and 14.|Analysis is based upon the 24 subjects who completed all study visits.||nmol/mL||Standard Deviation|Mean
123126|NCT00615992|Secondary|Global Assessment of Tolerability by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
123127|NCT00615992|Secondary|Global Assessment of Efficacy by Physician|Rating scale ranging from very good (best value) to not satisfactory (worst value)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||Participants|||Number
123131|NCT00615992|Primary|Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva|The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)|Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)|The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.||points on a scale||Standard Deviation|Mean
123132|NCT00615927|Secondary|Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas|The number of patients experiencing any serious adverse event or other (non-serious) adverse event during the study participation.|156 weeks|||participants|||Number
123133|NCT00615927|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|156 weeks|||participants|||Number
123134|NCT00615927|Secondary|Median Overall Survival (OS)|Time in weeks from the start of cycle 1 to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to date of death due to any cause, assessed up to 156 weeks|Median overall survival was not estimable for either arm as not enough events of death occurred||weeks||95% Confidence Interval|Median
123135|NCT00615927|Secondary|Median Progression-free Survival|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in weeks from the start of cycle 1 to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 156 weeks|||weeks||95% Confidence Interval|Median
123136|NCT00615927|Primary|12-month Progression Free Survival (PFS)|Percentage of participants surviving twelve months from the start of cycle 1 without progression of disease. PFS was defined as the time from the cycle 1 start date to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|12 months|||percentage of participants||95% Confidence Interval|Number
123137|NCT00615914|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.|during 18 months|Patients excluded from 1581 patients were: 15 who had no visit since the first prescription, 2 for no treatment, 10 patients who were irregularly enrolled patients (exclusion from analysis according to regulatory requirement) and 1 patient that had no safety data available. As a result, there were 1553 patients in the safety analysis set.||percentage of participants|||Number
123138|NCT00615914|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of Modified Hoehn & Yahr rating scale at baseline and at or after 18 months of treatment or at the time of discontinuation (1430).||Unit on a scale||Standard Deviation|Mean
123139|NCT00615914|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 18 months (or at the time of discontinuation)|The number of patients from the efficacy analysis set (1527) who had the assessment of UPDRS Part III total score at baseline and at or after 18 months of treatment or at the time of discontinuation (1356).||Unit on a scale||Standard Deviation|Mean
123140|NCT00615914|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|18 months|A total of 26 patients were excluded from 1553 patients (Administration to patients who did not suffer from PD: 20, No efficacy data available: 6). As a result, 1527 patients included to the efficacy analysis set.||Participants|||Number
123141|NCT00615836|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities."|From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).|Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure; therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.||participants|||Number
123142|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123143|NCT00615836|Secondary|Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score|"The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123144|NCT00615836|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score|"The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123145|NCT00615836|Secondary|Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123146|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123147|NCT00615836|Secondary|Change From Baseline in NQoL Bother/Concern Domain Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123148|NCT00615836|Secondary|Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score|"The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123162|NCT00615550|Secondary|Number of Subjects With Preterm Birth at ≤27 6/7, ≤34 6/7, and <36 6/7 Weeks Gestation.|Number of participants at <=27 6/7 , <=34 6/7, and <36 6/7.|Gestational Age at Delivery|Intent to Treat||participants|||Number
123194|NCT00613951|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
123149|NCT00615836|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score|"The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question “Night time urination: How much does this bother you?” on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||units on a scale||Standard Deviation|Mean
123150|NCT00615836|Secondary|Change From Baseline in Total Sleep Time|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||minutes||Standard Deviation|Mean
123151|NCT00615836|Primary|Change From Baseline in Initial Period of Undisturbed Sleep|"Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||minutes||Standard Deviation|Mean
123152|NCT00615836|Primary|Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids|"Percentage of participants with >33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||percentage of participants|||Number
123153|NCT00615836|Primary|Change From Baseline in Mean Number of Nocturnal Voids|"Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug.~Participants in the 10μg arm are included only until the time of dose escalation."|Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.|Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received >=1 dose of study drug and provided >=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.||nocturnal voids||Standard Deviation|Mean
123154|NCT00615719|Primary|The Presence of Acute Coronary Syndromes(ACS).|The presence of ACS was determined by either cardiac angiography, nuclear perfusion imaging or a clinical course deemed consistent with ACS by final chart review. The number of participants with ACS was determined.|During the presenting illness, usually within two to three days.|Only 30 evaluable patients in study powered for 80 patients.||participants|||Number
123155|NCT00615589|Secondary|Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression|Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.|3 years|||percentage of deaths||95% Confidence Interval|Number
123156|NCT00615589|Secondary|Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)|"Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.~Acute GVHD Grading:~Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus"|100 days, 2 years|||percentage of participants||95% Confidence Interval|Number
123157|NCT00615589|Secondary|Percentage of Patients With Treatment Related Mortality (TRM)||100 days, one-year|||percentage of patients||95% Confidence Interval|Number
123158|NCT00615589|Secondary|The Percentage of Patients Free From Progression at 1 Year|"One of the secondary outcomes that will be measured is progression free survival at 1 Year.~Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia."|1 Year|||percentage of patients||95% Confidence Interval|Number
123159|NCT00615589|Primary|The Percentage of Patients Alive 1 Year Post Transplant|The primary objective is overall survival, one year from the time of transplant.|1 Year|||percentage of patients||95% Confidence Interval|Number
123160|NCT00615550|Secondary|Number of Infants With a Birth Weight < 1500 Grams or < 2500 Grams|Assessment of birth weight < 1500 grams or < 2500 grams|date of delivery|Available birth weight.||participants|||Number
123161|NCT00615550|Secondary|Number of Neonates Who Died.||Delivery to 28 days|All infants with a known delivery date and status.||participants|||Number
123163|NCT00615550|Secondary|Number of Infants With Neonatal Morbidities Such as Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH), Proven Sepsis, and Necrotizing Enterocolitis (NEC)|"Each infant is scored based on the 7 morbidity and mortality events above:~0= no morbidity event~1 morbidity event~2 morbidity events~3 or more morbidity events~mortality"|Delivery Hospitalization (1-212 days)|||participants|||Number
123164|NCT00615550|Primary|Number of Participants With Birth <=32 6/7 Weeks Gestation.||9 to 13 weeks|Intent to Treat||participants|||Number
123165|NCT00615472|Primary|Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes|A battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.|Four months|||participants|||Number
123166|NCT00615459|Secondary|Peak FEV1 During 4 Hours Post Morning Dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|Day 1 (from 0 to 4 hours post morning dose)|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug.||Liters||Standard Error|Least Squares Mean
123167|NCT00615459|Primary|24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period|The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug. Patients were analyzed according to treatment they received.||Liters||Standard Error|Least Squares Mean
123168|NCT00615433|Secondary|CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment.|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||scale||95% Confidence Interval|Least Squares Mean
123169|NCT00615433|Primary|Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period.|The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.|Baseline and 6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||Units on a scale||95% Confidence Interval|Least Squares Mean
123170|NCT00614120|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-16|Safety Analysis Set is all randomised subjects who have been exposed to at least one dose of study products.||episodes|||Number
123171|NCT00614120|Secondary|Change in Fasting Lipid Profile, APO-B|Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||g/L||Standard Deviation|Median
123172|NCT00614120|Secondary|Change in Fasting Lipid Profile|"Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:~Total Cholesterol (TC)~Low-density Lipoprotein-cholesterol (LDL-C)~Very Low-density Lipoprotein-cholesterol (VLDL-C)~High-density Lipoprotein-cholesterol (HDL-C)~Triglyceride (TG)~Free Fatty Acid (FFA)"|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
123173|NCT00614120|Secondary|Change in Beta-cell Function|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point (%point)||Standard Deviation|Mean
123174|NCT00614120|Secondary|7-point Self-measured Plasma Glucose Profiles|Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).|week 0, 8, 12 and 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dl||Standard Deviation|Mean
123175|NCT00614120|Secondary|Change in Self-measured Fasting Plasma Glucose|Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Deviation|Mean
123176|NCT00614120|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to 16 weeks (end of treatment)|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Deviation|Mean
123177|NCT00614120|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).|week 0, week 16|The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Deviation|Mean
123178|NCT00614055|Secondary|Physical Examination|Physical examination is performed at baseline (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week 0, Week 8, Week 16||||||
123179|NCT00614055|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||beats/minute||Standard Deviation|Mean
123180|NCT00614055|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
123181|NCT00614055|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
123182|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||umol/L||Standard Deviation|Mean
123183|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
123184|NCT00614055|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Values at screening (Week -4) and at Week 16|Week -4, Week 16|The SAS included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
123185|NCT00614055|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123186|NCT00614055|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The FAS included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123187|NCT00614055|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
123188|NCT00614055|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.||mmol/L||Standard Error|Mean
123189|NCT00614055|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 16 weeks of treatment|Week 0, Week 16|The FAS included all randomised subjects and missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
123190|NCT00614055|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
123191|NCT00613951|Secondary|Physical Examination|Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 8, Week 16||||||
123192|NCT00613951|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.||beats/minute||Standard Deviation|Mean
123193|NCT00613951|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
123195|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16.||umol/L||Standard Deviation|Mean
123196|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
123197|NCT00613951|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -4) and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
123198|NCT00613951|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
123199|NCT00613951|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123200|NCT00613951|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123201|NCT00613951|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 2 subjects, mean SMPG values were missing.||mmol/L||Standard Error|Least Squares Mean
123202|NCT00613951|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis||percentage of glycosylated haemoglobin||Standard Deviation|Mean
123203|NCT00615290|Secondary|Patient Self Perception of the New Treatment|"Visual analogue scale range from 0 not at all satisfied to 100 extremely satisfied"|Day 0, month 3 and month 6|All enrolled patients||millimeter||Standard Deviation|Mean
123204|NCT00615290|Secondary|CD4 Count at 3 Months||3 months after inclusion|All enrolled patients with data at 3 months||cells/cubic millimeter||Inter-Quartile Range|Median
123205|NCT00615290|Secondary|Viral Load Response at 3 Months|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|3 months after inclusion|All enrolled patients with data at 3 months||copies/mL||Inter-Quartile Range|Median
123206|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL|Number of patients with a viral load < 50 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months||participants|||Number
123207|NCT00615290|Secondary|Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL|Number of patients with a viral load < 400 copies/mL after 3 months of treatment|3 months after inclusion|All enrolled patients with data at 3 months||participants|||Number
123208|NCT00615290|Secondary|CD4 Count at 1 Month||1 month after inclusion|All enrolled patients with data at 1 month||cells/cubic millimeter||Inter-Quartile Range|Median
123209|NCT00615290|Secondary|Viral Load Response at 1 Month|"Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL."|1 month after inclusion|All enrolled patients with data at 1 month||copies/mL||Inter-Quartile Range|Median
123210|NCT00615290|Secondary|Evaluation of Early Virological Response|Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10|1 month after inclusion|All enrolled patients with data at 1 month||participants|||Number
123211|NCT00615290|Primary|Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3|The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3|6 months after inclusion|All enrolled patients with data at 6 months||participants|||Number
123212|NCT00615264|Secondary|Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months|Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 Months|Modified Intent to Treat (MITT) Population||nmol*minute/L||Standard Error|Mean
123213|NCT00615264|Primary|Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Modified Intent to Treat (MITT) Population - all randomized patients who received at least one dose of study medication and who entered the study according to the definition of the target population, as defined by the inclusion and exclusion criteria in the study protocol||nmol*minute/L||Standard Error|Mean
123214|NCT00615199|Secondary|Time to First Response 100|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.||days||95% Confidence Interval|Median
123215|NCT00615199|Secondary|Time to First Response 70|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.||days||95% Confidence Interval|Median
123216|NCT00615199|Secondary|Time to First Clinical Remission|Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1 through Week 4|FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.||days||95% Confidence Interval|Median
123217|NCT00615199|Secondary|Number of Participants With Clinical Response 100 at Week 4|Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.||participants|||Number
123218|NCT00615199|Secondary|Number of Participants Achieving Clinical Remission at Week 4|Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.||participants|||Number
123219|NCT00615199|Secondary|Number of Participants With Clinical Response 70 at Week 1 and 2|Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 1, 2|FAS: all randomized participants who had either withdrawn as treatment failure or completed at least (>=)1 week of dosing and had >=1 valid CDAI score during active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside visit window. ‘n’=participants evaluable at given time point for each group.||participants|||Number
123220|NCT00615199|Primary|Number of Participants With Clinical Response 70 at Week 4|Clinical response 70: defined as a reduction in Crohn’s Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 4|Full Analysis Set (FAS): all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.||participants|||Number
123221|NCT00615108|Secondary|Overall Assessment by Attending Physicians|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:~4: Outstanding 3: Very satisfactory 2: Satisfactory~1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage||Percentage of Participants|||Number
123222|NCT00615108|Secondary|Overall Assessment by Patients|"Overall assessment was reported as a 5-point scale rated from 0 to 4 as below:~4: Outstanding 3: Very satisfactory 2: Satisfactory~1: Marginal 0: Not satisfactory"|01-Dec-2006 to 31-Dec-2008|Included the patients who took 20mg, 40mg, 80mg and unknown dosage.||Percentage of Participants|||Number
123224|NCT00615108|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control|BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.|01-Dec-2006 to 31-Dec-2008|Subjects include those who took 20mg, 40mg, 80mg and unknown dosage||Percentage of Participants|||Number
123225|NCT00615069|Secondary|Number of Subjects With One or More of the Following Events: Type I Endoleak, Device Migration, Major Procedural Bleeding Complications||Treatment through 1 year window post-procedure (through end of 1 year window, 546 days)|||Participants|||Number
123226|NCT00615069|Primary|Time to First Major Adverse Event Experienced by Subjects From the Time of Treatment Through 1 Year||Treatment through 1 year post-procedure (365 days)|||days||Standard Error|Mean
123227|NCT00615056|Secondary|Change From Baseline in MDASI–D Symptom Interference Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom Interference score is comprised of the average of 6 items on feeling or function from the MDASI-D core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last week; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycle 2-5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||Units on a Scale||95% Confidence Interval|Mean
123228|NCT00615056|Secondary|Change From Baseline in MD Anderson Symptoms Inventory Diarrhea (MDASI–D) Symptom Severity Score at Day 1 of Cycles 2-5, Day 1 of Every Odd-numbered Cycle Throughout the Study and End of Treatment (Cycle 65) or Withdrawal|Symptom severity score is comprised of average of 14 MDASI-D core items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling and diarrhea) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last week; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome. Total average score range: 0 to 10.|Baseline, Day 1 of cycles 2- 5, Day 1 of every odd-numbered cycle throughout the study and end of treatment (cycle 65) or withdrawal|ITT population. Here 'N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.||Units on a Scale||95% Confidence Interval|Mean
123229|NCT00615056|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).||Months||95% Confidence Interval|Median
123230|NCT00615056|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 130 weeks|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
123231|NCT00615056|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or up to 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
123232|NCT00615056|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or receive a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
123233|NCT00615030|Secondary|Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons|Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. On the morning and evening of Day 15 trough FEV1 (i.e. mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed. An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.|After 14 days of dosing|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means.||Liters||Standard Error|Least Squares Mean
123234|NCT00615030|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo|"Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate.~The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period."|After 14 days of treatment|The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means. This analysis included all patients who received indacaterol in the evening or placebo in their assigned treatment sequence.||Liters||Standard Error|Least Squares Mean
123235|NCT00615017|Secondary|Number of Patients Below Tumour Necrosis Factor (TNF)-Alpha Limit of Quantification (LOQ) at 24 Hours (n< LOQ)|Number of patients below tumour necrosis factor (TNF)-alpha limit of quantification (LOQ) at 24 hours (n< LOQ) measured by ELISA (LOQ = 1.3 pg/mL). Safety analysis set (ie all patients who started study drug infusion).|24 hours|Participants analyzed relates to the number of evaluable patients at the specified time point.||Participants|||Number
123236|NCT00615017|Secondary|Tmax of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.||Hours||Full Range|Median
123237|NCT00615017|Secondary|Cinf of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|Cinf of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg/mL||Full Range|Geometric Mean
123238|NCT00615017|Secondary|AUC(0-12) of Maintenance Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of maintenance dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|PK samples taken pre-dose of Doses 5,7 and 9, then at 0, 0.5, 1, 2, 8 and 12 h post dose 9 infusion|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg.h/mL||Full Range|Geometric Mean
123239|NCT00615017|Secondary|Time to Reach Cinf (Tmax) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|tmax of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||Hours||Full Range|Median
123240|NCT00615017|Secondary|Maximum (End of Infusion) Serum Concentration (Cinf) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3,4 and 5)|Cinf of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last)infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg/mL||Full Range|Geometric Mean
123241|NCT00615017|Secondary|AUC(0-12) of Loading Dose AZD9773 Serum Total Fabs (Cohorts 3, 4 and 5)|AUC(0-12) of loading dose AZD9773 serum total Fabs (cohorts 3, 4 and 5). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8 and 12 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg.h/mL||Full Range|Geometric Mean
123242|NCT00615017|Secondary|Total Apparent Clearance (CL) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|CL of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||mL/min/kg||Full Range|Mean
123243|NCT00615017|Secondary|Terminal Half-life (t1/2) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|t1/2 of single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, 12, 24, 48, and 72 h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||Hours||Full Range|Mean
123244|NCT00615017|Secondary|Area Under the Serum Concentration-time Curve From 0 to 12 Hours (AUC(0-12)) of Single Dose AZD9773 Serum Total Fabs (Cohorts 1 and 2)|AUC(0-12) for single dose AZD9773 serum total Fabs (cohorts 1 and 2). PK analysis set (ie a subset of the safety analysis set including only those patients without important deviations that could affect the PK).|Day 1 [PK samples taken pre-dose, the end of each infusion rate and then at 0.5, 1, 2, 8, and 12h post-(last) infusion]|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg.h/mL||Full Range|Geometric Mean
123245|NCT00615017|Secondary|Change From Baseline in Sequential Organ Failure Assessment (SOFA) Scores|Change in SOFA (Sequential Organ Failure Assessment) scores from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. The SOFA score is out of a maximum of 24 (units on a scale 0 to 24). The higher the score, the worse the organ system functioning. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.||units on a scale (0 to 24)||Full Range|Mean
123246|NCT00615017|Secondary|28-Day Mortality|The number of patients who had died at Day 28. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|||Participants|||Number
123247|NCT00615017|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.||kg||Full Range|Mean
123248|NCT00615017|Primary|Change From Baseline in Calculated Mean Arterial Blood Pressure|Change in calculated mean arterial pressure from baseline (pre-infusion) to Day 14 [calculated as Day 14 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 14|Participants analyzed relates to the number of evaluable patients at the specified time point.||mmHg||Full Range|Mean
123249|NCT00615017|Primary|Change From Baseline in QT With Fridericia Correction (QTcF), Where QT is Measured by ECG, and is the Time Interval Between the Start of the Q Wave and the End of the T Wave in the Heart's Electrical Cycle.|Change in QTcF from baseline (pre-infusion) to Day 1 (end of infusion) for Cohorts 1 and 2 [calculated as Day 1 mean minus baseline mean] and Day 5 (end of infusion) for Cohorts 3 to 5 and placebo [calculated as Day 5 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 1 (end of infusion) for Cohorts 1 and 2; Day 5 (end of infusion) for Cohorts 3 to 5 and placebo|Participants analyzed relates to the number of evaluable patients at the specified time point.||msec||Full Range|Mean
123250|NCT00615017|Primary|Change From Baseline in Troponin I|Change in troponin I values from baseline (pre-infusion) to Day 6 [calculated as Day 6 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 6|Participants analyzed relates to the number of evaluable patients at the specified time point.||μg/L||Full Range|Mean
123251|NCT00615017|Primary|Change From Baseline in Prothrombin Time Values|Change in prothrombin time values from baseline (pre-infusion) to Day 7 [calculated as Day 7 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|Day 7|Participants analyzed relates to the number of evaluable patients at the specified time point.||sec||Full Range|Mean
123252|NCT00615017|Primary|Change From Baseline in Platelet Count Values|Change in platelet count values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||10^9/L||Full Range|Mean
123253|NCT00615017|Primary|Change From Baseline in White Blood Cell Values|Change in white blood cell values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||10^9 cells/L||Full Range|Mean
123254|NCT00615017|Primary|Change From Baseline in Haemoglobin Values|Change in haemoglobin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||g/L||Full Range|Mean
123255|NCT00615017|Primary|Change From Baseline in Bilirubin Values|Change in bilirubin values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μmol/L||Full Range|Mean
123256|NCT00615017|Primary|Change From Baseline in Aspartate Aminotransferase Values|Change in aspartate aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μkat/L||Full Range|Mean
123257|NCT00615017|Primary|Change From Baseline in Alanine Aminotransferase Values|Change in alanine aminotransferase values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μkat/L||Full Range|Mean
123258|NCT00615017|Primary|Change From Baseline in Creatinine Values|Change in creatinine values from baseline (pre-infusion) to follow-up (28 days after the start of study drug administration) [calculated as Day 28 mean minus baseline mean]. Safety analysis set (ie all patients who started study drug infusion).|End of study (Day 28)|Participants analyzed relates to the number of evaluable patients at the specified time point.||μmol/L||Full Range|Mean
123259|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||L/h||90% Confidence Interval|Mean
123267|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mmol/L||Standard Error|Mean
123260|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng•h/mL||90% Confidence Interval|Mean
123261|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.|RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens|||ng/mL||90% Confidence Interval|Mean
123262|NCT00614991|Primary|CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||L/H||90% Confidence Interval|Mean
123263|NCT00614991|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng•h/mL||90% Confidence Interval|Mean
123264|NCT00614991|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004."|Day 0 through Day 49|||participants|||Number
123265|NCT00614991|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens|||ng/mL||90% Confidence Interval|Mean
123266|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mmol/L||Standard Error|Mean
123268|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mmol/L||Standard Error|Mean
123269|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mg/dL||Standard Error|Mean
123270|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mg/dL||Standard Error|Mean
123271|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline, Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||mg/dL||Standard Error|Mean
123272|NCT00614939|Secondary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.|Baseline , Week 52|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.||Percent||Standard Error|Mean
123273|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mmol/L||Standard Error|Mean
123274|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mmol/L||Standard Error|Mean
123275|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mmol/L||Standard Error|Mean
123276|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mg/dL||Standard Error|Mean
123334|NCT00614484|Secondary|Treatment Related Toxicities.|"grade 3 or higher esophageal toxicity~Toxicity is categorized either early or late phase.~Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter"|Monthly for duration of participant lifespan. Average lifespan 1-2 years|||participants|||Number
123277|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mg/dL||Standard Error|Mean
123278|NCT00614939|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline, Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||mg/dL||Standard Error|Mean
123279|NCT00614939|Primary|Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)|Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.|Baseline , Week 12 (LOCF)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.||Percent||Standard Error|Mean
123280|NCT00614926|Secondary|"Number of Impaired Scores on Neuropsychological (Brief) Test Battery"|This was an initial plan but the large majority of patients were too impaired (either anarthric or unable to use hands) to complete the tests we had selected so this outcome measure turned out to be unfeasible. Therefore, 0 participants were analyzed.|4 weeks|||participants|||Number
123281|NCT00614926|Primary|"Participants Considered Responders (Scored 1 or 2) on Clinical Global Impressions Scale"|"The CGI is a standardized assessment tool widely used in clinical psychopharmacology trials as an outcome measure. Scores range from 1= very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5-7 = worse. We use it as a dichotomous measure with scores of 1 or 2 signifying responder and all the rest as non-responder using all available data including clinician judgement, and ratings scales."|4 weeks|Analysis was Intention to Treat (ITT) including Last-Observation-Carried-Forward (LOCF) as indicated. Proof of concept study so N was based on accrual feasibility.||"participants considered responders"|||Number
123282|NCT00614913|Primary|Median Survival Without Tumor Progression|Median time until disease progression or death|3 months|All participants||months||95% Confidence Interval|Median
123283|NCT00614913|Primary|3-year Survival Without Tumor Progression for Patients Within the Milan Criteria|Percent of participants alive and without tumor progression 3 years following treatment.|3 months|Participants that were within the Milan criteria||percentage of participants|||Number
123284|NCT00614874|Secondary|Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3||percent predicted||Standard Deviation|Mean
123285|NCT00614874|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 in liters|patients were assessed at baseline and 12 weeks|Two subjects withdrew from the study in visit 3||Liters||Standard Deviation|Mean
123286|NCT00614874|Secondary|Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion|Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.|patients were assessed at baseline and 12 weeks|2 patients withdrew from the study in visit 3||parts per billion||Standard Deviation|Mean
123287|NCT00614874|Primary|Methacholine Responsiveness as Assessed by PC20,|PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%|patients were assessed at baseline and at 12 weeks|3 subjects were not included in the final analysis due to missing data. Two subjects withdrew by visit 3. 1 had missing data at visit 2 due to equipment failure.||mg/mL||Standard Deviation|Mean
123288|NCT00614614|Primary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.||Subjects|||Number
123289|NCT00614614|Primary|Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on Nimenrix 2 and ActHIB- Infanrix Group.||EL.U/mL||95% Confidence Interval|Geometric Mean
123290|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
123335|NCT00614484|Primary|Overall Survival.|Median survival time following treatment.|Monthly for duration of participant lifespan. Average lifespan 1-2 years|||Months||95% Confidence Interval|Median
123291|NCT00614614|Primary|Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. It was performed on the Nimenrix 2 and ActHIB- Infanrix Group.||Subjects|||Number
123292|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
123293|NCT00614614|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.||Subjects|||Number
123294|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||Subjects|||Number
123295|NCT00614614|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During a 31-day follow-up period (Day 0-30)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
123296|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)|The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.||Subjects|||Number
123297|NCT00614614|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits|NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
123298|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.||Subjects|||Number
123299|NCT00614614|Secondary|Number of Subjects Reporting Any Rash|Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.|From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.||Subjects|||Number
123300|NCT00614614|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase|Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature > 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.||Subjects|||Number
123301|NCT00614614|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine|Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.|During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase|The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.||Subjects|||Number
123302|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
123303|NCT00614614|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||Subjects|||Number
123304|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||Subjects|||Number
123305|NCT00614614|Secondary|Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group|Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||EL.U/mL||95% Confidence Interval|Geometric Mean
123306|NCT00614614|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.||Subjects|||Number
123307|NCT00614614|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value|The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.||Subjects|||Number
123308|NCT00614614|Secondary|Anti-D and Anti-T Geometric Mean Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).|One month after vaccination with Infanrix at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
123309|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||Subjects|||Number
123310|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|Prior to vaccination at 15-18 months of age (Month 13)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
123311|NCT00614614|Secondary|Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||titer||95% Confidence Interval|Geometric Mean
125645|NCT00593606|Primary|Change in Serum Glutamic Oxaloacetic Transaminase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
123312|NCT00614614|Secondary|Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||Subjects|||Number
123313|NCT00614614|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group|The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4|One month after vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.||Subjects|||Number
123314|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||titer||95% Confidence Interval|Geometric Mean
123315|NCT00614614|Primary|Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group|Antibody titers were expressed as Geometric mean titers (GMTs)|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||titer||95% Confidence Interval|Geometric Mean
123316|NCT00614614|Primary|Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 15-18 months of age (Month 14)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.||Subjects|||Number
123317|NCT00614614|Primary|Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group|The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8|One month post vaccination at 12-15 months of age (Month 11)|Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.||Subjects|||Number
123318|NCT00614575|Primary|Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented.|for 12 weeks|Safety Analysis Set||percentage of participants|||Number
123319|NCT00614575|Secondary|Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement.|After 12 weeks or at the time of discontinuation|Efficacy Analysis Set||units on a scale||Standard Deviation|Mean
123320|NCT00614575|Secondary|Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score|Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set||Unit on a scale||Standard Deviation|Mean
123321|NCT00614575|Secondary|Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score|The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set||Unit on a scale||Standard Deviation|Mean
123322|NCT00614575|Secondary|Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement.|Baseline and after 12 weeks (or at the time of discontinuation)|Efficacy analysis set||Unit on a scale||Standard Deviation|Mean
123323|NCT00614575|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|for 12 weeks after initiation of the treatment|Efficacy analysis set||participants|||Number
123336|NCT00614458|Primary|A Change in the Number of HIV Infected Cells.|A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment.|20 weeks|All participants analyzed per protocol||infected cells /million cells||95% Confidence Interval|Median
123362|NCT00613938|Secondary|Total Pain Relief (TOTPAR)at 48 Hours|Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief.|48 hours|Intent-to-treat||scores on a scale||Standard Deviation|Mean
123324|NCT00614523|Secondary|Annualized Rate of Patient-reported Bleeding Events|The number of bleeding events was obtained from the thrombocytopenia symptoms (Th-symptoms) survey. Patients reported spontaneous bleeding to have occurred 0, 1 or 2, 3 or 4, 5 or 6, or 7 or more times in the past week. The lower threshold of bleeding counts is used for conservative purposes (i.e., the “3” is used for the response option of “3 or 4 times”). Exposure adjusted event rate per 100 patient-years = number of events / patient-year * 100.|Test Treatment Period (Weeks 1-26)|The Patient Reported Outcomes (PRO) analysis set consists of patients in the full analysis set who also completed the baseline and at least one post-baseline assessment for any PRO measure.||events per 100 patient-years||95% Confidence Interval|Mean
123325|NCT00614523|Secondary|Kaplan-Meier Estimate of Survival at Month 12|Overall survival was calculated using Kaplan-Meier methods.|Month 12, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.||percentage of participants||95% Confidence Interval|Number
123326|NCT00614523|Secondary|Time to Death|Overall survival was calculated using Kaplan-Meier methods. For patients who discontinued early, additional information from the long term follow-up are added (closest available follow-up information up to 58 weeks).|From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.||months||95% Confidence Interval|Median
123327|NCT00614523|Secondary|Number of Participants Who Died||From randomization to 58 weeks, the end of study visit or the closest available follow-up information up to 58 weeks from the long term follow-up for those who discontinued the study early, with a data cut-off date of 20 July 2012.|Full analysis set includes all randomized patients.||participants|||Number
123328|NCT00614523|Secondary|Exposure-adjusted Total Duration of Platelet Hematologic Improvement (HI-P) in the Absence of Platelet Transfusions|Duration for participants who did not report HI-P during the period is 0. A platelet hematologic improvement (HI-P) is defined by an MDS International Working criteria as patients with a baseline platelet count of ≥ 20 x 10^9/L achieving an absolute increase of ≥ 30 x 10^9/L or increasing the platelet count to above 20 x 10^9/L and by at least 100% in patients with a baseline of < 20 x 10^9/L for at least 8 consecutive weeks. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint. The durations of HI-P are cumulative if more than one incidence occurred. Exposure adjusted event rate per 100 patient-weeks = total number of weeks / patient-weeks * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||weeks per 100 patient-weeks||95% Confidence Interval|Mean
123329|NCT00614523|Secondary|Number of Participants With Platelet Hematologic Improvement (HI-P)|Platelet Hematologic Improvemen defined by the international working group (IWG) as: an absolute increase in platelet count of ≥ 30 x 10^9/L for a patient starting with a platelet count of ≥ 20 x 10^9/L or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a patient that started with a platelet count < 20 x 10^9/L. To account for any possible contribution from platelet transfusions, platelet counts within 3 days following administration of platelet transfusion is not counted towards the platelet hematologic improvement endpoint. If no platelet measurements are available on the weekly scheduled dose day, then that week is not counted towards the platelet hematologic improvement endpoint.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||Participants|||Number
123330|NCT00614523|Secondary|Annualized Rate of Total Platelet Transfusion Units|The time from first dose of study drug to the last dose of 26-week test treatment period. A unit of platelets is defined as a single pack of pooled platelet-rich plasma comprised of 6 to 8 individual platelet concentrate packs (200 to 400 mL), a single pack of pooled buffy-coat concentrate, or 1 apheresis (single donor) concentrate. Exposure adjusted event rate per 100 patient-years = events / patient-years * 100.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized subjects||units per 100 patient-years||95% Confidence Interval|Mean
123331|NCT00614523|Secondary|Annualized Rate of Overall Bleeding Events|The time from first dose of study drug to the last dose of 26-week test treatment period. A bleeding event is defined as any bleeding event reported during the test treatment period. Bleeding events that continue for more than 7 days are counted as separate events every eighth day. Multiple events that arose from one organ system on one day are collapsed into one single event. Exposure adjusted event rate per 100 patient-years = events / patient-year * 100).|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||events per 100 patient-years||95% Confidence Interval|Mean
123332|NCT00614523|Secondary|Annualized Rate of Platelet Transfusion Events|A discrete platelet transfusion is any number of platelet transfusion administered within a 3-day period. Transfusions administered more than 3 days apart are counted as separate events. Transfusion given in the absence of any bleeding, when platelet count is >10x10^9/L, is not counted as a platelet transfusion event. Events with start date between the first dose date and the last dose date of the test treatment period +7 days are included. Exposure adjusted event rate per 100 patient-years = (events / patient-years * 100). Patient Year = total patient years of exposure to investigational product during 26 weeks test treatment period.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||events per 100 patient-years||95% Confidence Interval|Mean
123333|NCT00614523|Primary|Number of Clinically Significant Bleeding Events|A clinically significant bleeding event is defined as any bleeding event of grade ≥ 2 per the modified World Health Organization (WHO) bleeding scale: • Grade 0 = no bleeding • Grade 1 = petechia or mucosal or retinal bleeding not requiring intervention • Grade 2 = melena, hematemesis, hematuria, hemoptysis • Grade 3 = bleeding required red cell transfusion • Grade 4 = retinal bleeding with visual impairment • Grade 5 = non-fatal cerebral bleeding • Grade 6 = fatal cerebral bleeding • Grade 7 = fatal non-cerebral bleeding. Bleeding events that continue for more than 7 days were counted as separate events every eighth day. Multiple events that arose from one organ system on one day were collapsed into one single event. Bleeding events with a start date between the first dose date and the last dose date of the test treatment period+7 days are included.|Test Treatment Period (Weeks 1-26)|Full analysis set includes all randomized patients.||events|||Number
125646|NCT00593606|Primary|Change in Potassium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
123337|NCT00614445|Primary|Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).|The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe).|Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)|Planned: Approximately 280 subjects (140 subjects per treatment group) were to be enrolled to achieve 200 evaluable subjects. Analyzed: 280 enrolled subjects [261 subjects in the intent-to-treat safety (ITT-S) population; 256 subjects in the intent-to-treat efficacy (ITT-E) population].||PUQE Score||95% Confidence Interval|Mean
123338|NCT00614406|Primary|Menstrual Cycle Length|Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.|3 months|Intention to Treat (ITT)||Days||Standard Deviation|Mean
123339|NCT00614393|Secondary|Overall Response Rate (ORR) of Dalotuzumab in Combination With Cetuximab + Irinotecan Versus ORR of Cetuximab + Irinotecan Alone in Participants With Wild Type of Colorectal Cancer|ORR, using RECIST 1.0, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Every 6 weeks (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.||Percentage of Participants|||Number
123340|NCT00614393|Primary|Percentage of Participants Who Experience an AE of Infusion Site Reaction|The percentage of participants who experienced an AE of infusion site reaction is presented.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
123341|NCT00614393|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The percentage of participants who discontinued study drug due to an AE is presented.|Up to last dose of study drug (Up to 32 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
123342|NCT00614393|Primary|Percentage of Participants Who Have a Drug-related Clinical or Laboratory CTCAE Grade 3 to 5 Toxicity|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Drug-related AEs were those AEs that were possibly, probably, or definitely related to study drug or protocol-specified procedures. Participants were monitored for AEs related to dalotuzumab or placebo until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the NCI CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The APaT population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
123343|NCT00614393|Primary|Percentage of Participants Who Have a Clinical or Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 to 5 Toxicity|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. (Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4=Life-threatening consequences; urgent intervention indicated. Grade 5=Death related to AE.) Participants were monitored for AEs until the earlier of study discontinuation or 30 days after dalotuzumab/placebo discontinuation. AE grades were assessed using the National Cancer Institute (NCI) CTCAE, version 3.0.|Up to 30 days after last dose of study drug (Up to 33 months)|The All Participants as Treated (APaT) population consisted of all randomized participants who received ≥1 dose of study drug. Participants were included in the treatment group corresponding to the study drug they actually received.||Percentage of Participants|||Number
123344|NCT00614393|Primary|Progression-free Survival (PFS)|The PFS of participants with metastatic CRC expressing the wtKRAS genotype was defined as the time from the first day of study treatment to the first documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST 1.0) as documented by an independent core laboratory, or death due to any cause, whichever occurred first. Disease progression was defined as either a 20% or greater relative increase in the sum of diameters of target lesions OR an absolute increase of at least 5mm in the sum of lesions or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Up to last dose of study drug (Up to 32 months)|The ITT population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.||Months||Full Range|Median
123360|NCT00614315|Secondary|Number of Device/Procedure-related Adverse Events(Safety of Delivery)|Device/Procedure-related adverse events from the index procedure through 30 days post procedure|Index Procedure to 30 days|||Number of Device/Procedure events|||Number
123345|NCT00614393|Primary|Overall Survival (OS)|The OS of participants with metastatic colorectal cancer (CRC) expressing the KRAS wild-type (wtKRAS) tumor genotype (indicating no detection of KRAS mutation) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and is reported in months.|Up to 12 weeks after last dose of study drug (Up to 35 months)|The Intent-to-Treat (ITT) population consisted of all participants who had a wtKRAS tumor genotype. The efficacy analyses were planned for and only included participants from the DB portion of the study. Participants from the OL portion were excluded from the analyses. Participants were counted in the group to which they were randomized.||Months||Full Range|Median
123346|NCT00614380|Secondary|Trough DBP Control Pre- and Post- Uptitration|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration|At any point during open-label treatment|Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
123347|NCT00614380|Secondary|Additional Reduction in SBP by Use of Additional Antihypertensive Therapy|Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Deviation|Mean
123348|NCT00614380|Secondary|Additional Reduction in DBP by Use of Additional Antihypertensive Therapy|Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Deviation|Mean
123349|NCT00614380|Secondary|Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control|The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
123350|NCT00614380|Secondary|Time to First Additional Antihypertensive|Time from first intake of medication to first intake of an antihypertensive other than the study drug|At any point during open-label treatment|Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Days||Standard Deviation|Mean
123351|NCT00614380|Secondary|Trough Blood Pressure (BP) Normality Classes|The number of patients who reach predefined BP categories|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
123352|NCT00614380|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
123353|NCT00614380|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
123354|NCT00614380|Secondary|Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in SBP in this study|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
123355|NCT00614380|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement||mmHg||Standard Error|Least Squares Mean
123356|NCT00614380|Secondary|Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7|The difference between the last available troughs represents the additional reduction in DBP in this study|End of study (34 weeks or last value on treatment)|Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement||mmHg||Standard Error|Least Squares Mean
123357|NCT00614380|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.|End of study (34 weeks or last value on treatment)|All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose||mmHg||Standard Error|Least Squares Mean
123358|NCT00614380|Secondary|Trough Seated Systolic Blood Pressure (SBP) Control|The number of patients who reach the target SBP of <140mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
123359|NCT00614380|Primary|Trough Seated Diastolic Blood Pressure (DBP) Control|The number of patients who reach the target DBP of <90mmHg|End of study (34 weeks or last value on treatment)|The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose||Participants|||Number
123363|NCT00613938|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3|Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3|Baseline and 3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||percentage of participants|||Number
123364|NCT00613938|Secondary|SPID at 24 Hours Relative to First Dose|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|24 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||Scores on a scale||Standard Deviation|Mean
123365|NCT00613938|Secondary|The SPID at 12 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|12 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||Scores on a scale||Standard Deviation|Mean
123366|NCT00613938|Secondary|Time to First Rescue Pain Medication Use.|The effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication.|3 days|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.|||||
123367|NCT00613938|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief.|48 hours|The primary analysis set was the Intent to Treat (ITT) analysis set that included all subjects who were randomized, received at least one dose of study drug and had a non-missing baseline pain intensity score.||Scores on a scale||Standard Deviation|Mean
123368|NCT00613925|Secondary|Sample Adequacy|adequacy of sample obtained for examination by a pathologist|at time of biopsy|||percentage of participants|||Number
123369|NCT00613925|Primary|Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS).|"The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain in My Life (furthest point to the right)."|2 minutes after biopsy procedure|To demonstrate a 20 mm difference on the 100 mm visual analog scale, sample size of 35 women in each group (80% power, 0.05 alpha, SD 30mm)||mm||Standard Deviation|Mean
123370|NCT00613730|Secondary|Percentage of Participants With Overall Response|Overall Response defined as the percentage of participants with complete or partial response (CR or PR), as defined by modified RECIST. CR: Disappearance of all target and non-target lesions. PR: Either at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameters (SLD) and no progression of existing non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|Overall study|Study was terminated after enrolling 3 participants. This outcome was not evaluated.|||||
123371|NCT00613730|Secondary|Progression-free Survival|Progression-Free Survival was defined as the time from Study Day 1 to the date of disease progression or the date of death due to any cause (whichever comes earlier). Disease progression is determined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria or per physician’s assessment based on symptom progression.|Up to 25 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.|||||
123372|NCT00613730|Primary|Overall Survival at 1 Year|"The survival time is calculated from Study Day~1 (ie, the first day that a participant receives study treatment with the gemcitabine regimen in combination with panitumumab) to the date of death due to any cause."|12 months|Study was terminated after enrolling 3 participants. This outcome was not evaluated.|||||
123373|NCT00613626|Secondary|Assess VEGF Polymorphisms and Correlate Subject Response||24 months|This data was not collected for the safety lead-in participants.||probability|||Number
123374|NCT00613626|Secondary|Measure Overall Survival for Each Arm||24 months|||Months||95% Confidence Interval|Median
123375|NCT00613626|Secondary|Measure Disease Control Rate (CR + PR+ SD) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( >=20% increase in the sum of the longest diameter of the target lesions).|24 months|12 participants were not analyzed due to missing data.||percentage of participants||95% Confidence Interval|Number
124416|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
123376|NCT00613626|Secondary|Measure the Response Rate (CR + PR) in Each Arm|Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions.|24 months|12 participants are excluded due to missing data.||percentage of participants||95% Confidence Interval|Number
123377|NCT00613626|Secondary|Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities|Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.|6 weeks (2 Cycles)|The participants from the safety run-in cohort were combined with the participants from ARM B for analysis of safety.||percentage of participants|||Number
123378|NCT00613626|Primary|Time to Disease Progression - Median Time to Progression and Log-Rank Test|Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.|24 months|Two participants from Arm A and Two Participants from Arm B were inevaluable for the time to disease progression analysis. (Reasons inevaluable include: toxicity and withdrawal of consent)||Months||95% Confidence Interval|Median
123379|NCT00613574|Secondary|Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
123380|NCT00613574|Secondary|Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS|Physician Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
123381|NCT00613574|Secondary|Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS|Patient Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
123382|NCT00613574|Secondary|Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)|Patient Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).|final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||participants|||Number
123383|NCT00613574|Secondary|Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks|Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites|Visit 1 to Visit 3 (baseline and 8 weeks)|Full Analysis Set (Intent-to-Treat population) and only patients from selected sites||liters||Standard Deviation|Mean
123384|NCT00613574|Secondary|Change From Baseline for Forced Vital Capacity After 8 Weeks|Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||liters||Standard Deviation|Mean
123385|NCT00613574|Primary|Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks|Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)|baseline and final visit (8 weeks)|Full Analysis Set (Intent-to-Treat population)||liters||Standard Deviation|Mean
123386|NCT00613509|Secondary|Number of Participants Reporting a Grade 3 or Grade 4 Adverse Events by Preferred Term|"Common Terminology Criteria for Adverse Events (CTCAE) definitions:~Grade 3 is a severe adverse event; Grade 4 is a life-threatening or disabling adverse event."|Day 0 to 12 months post last vaccination|Safety assessments were conducted in the As-treated safety population.||Participants|||Number
123387|NCT00613509|Secondary|Best Overall Objective Response as Mean Duration of Response (Weeks) in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as mean duration of response were assessed in the intent-to-treat (ITT) evaluable population.||Weeks||Full Range|Mean
123388|NCT00613509|Primary|Progression-Free Survival Time by Response Evaluation Criteria in Solid Tumor (RECIST) Criteria in the Intent-to-treat Population|Progression-Free Survival was assessed by the Response Evaluation Criteria in Solid Tumor criteria from the computed tomography (CT) scans, as per-protocol|Day 0 - up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.||Weeks||Inter-Quartile Range|Median
123389|NCT00613509|Other Pre-specified|Summary of Cellular Immune Response to the Vaccination or Treatment (Percent Regulatory T-Cells Responses)|The immunogenicity of the treatment regimens was assessed by regulatory T-cell responses as assessed primarily by the multi-parametric intracellular cytokine staining (ICS) assay.|Day 0 to 32 weeks post 1st vaccination or treatment|Immunologic responses were assessed in the per-protocol evaluable population.||Percent Cell Count||Standard Deviation|Mean
123390|NCT00613509|Primary|Summary of Disease Progression in Study Participants, Intent-to-treat Population|Number of evaluable study participants who had died or experienced objective disease progression (no clinical objective response to treatment as evaluated by computed tomography [CT] scans or physical examination).|Day 0 up to 35 weeks post 1st vaccination or treatment|The Progression-Free Survival Time were assessed in the intend-to-treat (ITT) evaluable population.||Participants|||Number
123391|NCT00613509|Secondary|Best Overall Objective Response in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response were assessed in the intent-to-treat (ITT) evaluable population.||Percentage of participants|||Number
123910|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
123392|NCT00613509|Secondary|Best Overall Objective Response as Number of Participants Responding in the Intent-to-treat Population|Objective response rate (ORR) is the sum of complete response (CR) and partial response (PR) Complete response = Disappearance of all target lesions. Partial response = At least a 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Day 0 to 32 weeks post 1st vaccination or treatment|The best overall objective response as number of participants responding was assessed in the intent-to-treat (ITT) evaluable population.||Particpants|||Number
123393|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD4 T-Cell Positive Response by Antigen|The Vaccine-induced increase of CD4 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.||Participants|||Number
123394|NCT00613509|Other Pre-specified|Number of Participants With a Vaccine-Induced Increase of CD8 T-Cell Positive Response by Antigen|The vaccine-induced increase of CD8 T-Cell positive response by antigen post-vaccination during the observation period compared to the screening values.|Day 0 to 32 weeks post 1st vaccination|Immunologic responses were assessed in the Per-protocol evaluable population.||Participants|||Number
123395|NCT00613405|Secondary|Current Mood as Assessed by the Mood Form||~2 hours||||||
123396|NCT00613405|Secondary|Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)||~2 hours||||||
123397|NCT00613405|Secondary|Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR||~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).||||||
123398|NCT00613405|Primary|Subjective Craving of Marijuana|Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving|approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).|||Scores on a Scale||Standard Deviation|Mean
123399|NCT00613379|Primary|Maximum Change in Viral Load Following Initiation of Treatment.|The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).|59 days|All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.||Log10copies HIV-1 RNA/mL||Standard Error|Mean
123400|NCT00613366|Secondary|Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).|"Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|At time of IUD insertion|ITT||mm||Standard Deviation|Mean
123401|NCT00613366|Primary|The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).|"Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0=No Pain (furthest point to the left) to 100=Worst Pain of My Life (furthest point to the right)."|Time of IUD insertion|Intent to Treat (ITT)||mm||Standard Deviation|Mean
123402|NCT00613327|Secondary|Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.||Percent change||Standard Deviation|Mean
123403|NCT00613327|Secondary|Visual Analogue Scale (VAS) Score for Dry Mouth|Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth).|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.||Units on a scale||Standard Deviation|Mean
123404|NCT00613327|Secondary|Mean Severity of Urinary Urgency at Urination|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency.|Baseline, Week 6, 12 or ED|Data was reported in individual participant listings as planned, but not statistically summarized for analysis.|||||
123405|NCT00613327|Secondary|Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Percent change||Standard Deviation|Mean
123406|NCT00613327|Secondary|Frequency of Urinary Urgency and Urinary Incontinence|Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Episodes per day||Standard Deviation|Mean
123407|NCT00613327|Secondary|Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)*100.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Percent change||Standard Deviation|Mean
123408|NCT00613327|Secondary|Mean Voiding Frequency|Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle.|Baseline, Week 6, 12 or ED|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.||Urinations per day||Standard Deviation|Mean
123409|NCT00613327|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12|The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as ([Actual total raw score – lowest possible value of raw score]/range)*100 for symptom bother where higher score indicates greater symptom bother and as ([Highest possible raw score-Actual total raw score]/Raw score range)*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL.|Baseline, Week 6, 12 or early discontinuation (ED)|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.||Units on a scale||Standard Deviation|Mean
123410|NCT00613327|Secondary|Number of Participants With Response to Patient’s Perception of Bladder Condition (PPBC) Questionnaire|"Participant’s perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered “Which of the following statements describes your bladder condition best at the moment? on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem."|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.||Participants|||Number
123411|NCT00613327|Secondary|Number of Participants With Response to Patient’s Perception of Treatment Benefit (PPTB) Questionnaire|The PPTB was used to assess participant’s perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory.|Week 2, 4, 6 and 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.||Participants|||Number
123412|NCT00613327|Secondary|Patient’s Perception of Symptom Improvement (PPSI) Score for Overactive Bladder|Participant’s perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
123554|NCT00611559|Secondary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL~Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123413|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
123414|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime [period from time of going to bed to time planned to wake up in the morning]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
123415|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
123416|NCT00613327|Secondary|Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12|Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.|Baseline and Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
123417|NCT00613327|Primary|Percentage of Participants Who Achieved Treatment Goal|Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.|Week 12|ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Missing data at Week 12 were imputed using last observation carried forward (LOCF).||Percentage of participants||95% Confidence Interval|Number
123418|NCT00613314|Secondary|Percentage of Patients With Presence of Metabolic Risk Factor|"Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely:~a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities,~based on patients’ Medical History"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||Percentage of patients|||Number
123419|NCT00613314|Primary|Change in Diastolic Blood Pressure (DBP) From Baseline|Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||mmHg||Standard Deviation|Mean
123420|NCT00613314|Primary|Change in Systolic Blood Pressure (SBP) From Baseline|Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)|Baseline and 60 days|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||mmHg||Standard Deviation|Mean
123421|NCT00613314|Primary|Response Rate at the End of 60 Day Period|"Response rate on Blood Pressure:~Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline.~Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline.~Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|At the end of 60 day period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||Percentage of patients|||Number
123422|NCT00613314|Primary|Response Rate at the End of 30 Day Period|"Response rate of Blood Pressure assessed in the following categories:~Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline~Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg"|End of 30 day Period|ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available||Percentage of patients|||Number
124729|NCT00603239|Secondary|Change in Fasting Serum Glucose (FSG)|Change in FSG from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||mmol/L||Standard Error|Least Squares Mean
123423|NCT00613301|Secondary|Change From Baseline in Modified Hoehn & Yahr Rating Scale|A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (295) means a population who have the assessment of Modified Hoehn & Yahr rating scale at baseline and at least one post-visit after administration of pramipexole.||Unit on a scale||Standard Deviation|Mean
123424|NCT00613301|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score|Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.|Baseline and at 36 months (or at the time of discontinuation)|The number of patients (291) means a population who have the assessment of UPDRS Part III total score at baseline and at least one post-visit after administration of pramipexole.||Unit on a scale||Standard Deviation|Mean
123425|NCT00613301|Secondary|Clinical Global Impression of Improvement|Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).|after 36 months treatment|There were 346 patients in the safety analysis set. Patients excluded from this population: 5 because of administration to patients who didn’t suffer from PD and 2 with no efficacy data available. As a result, 339 patients were evaluated for efficacy.||Participants|||Number
123426|NCT00613301|Primary|Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this Post Marketing Surveillance (PMS) was to obtain safety data in Parkinson's disease (PD) patients without concomitant use of levodopa for 3 years.|during 36 months|364 patients had available case report forms. Patients excluded: 5 patients with no visit since the first prescription, 12 irregularly enrolled patients, 9 excluded from analysis according to regulatory requirement, and 1 patient with no safety data available. As a result, there were 346 patients in the safety analysis set.||Proportion (percentage of participants)|||Number
123427|NCT00613106|Primary|Number of Participants With Treatment Emergent Adverse Events|"The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as Has anything bothered you since your last visit or is anything bothering you now? Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event."|28 weeks|||participants|||Number
123428|NCT00613080|Secondary|Rate of Anterior Posterior Resections||From registration to end of follow-up||||||
123429|NCT00613080|Secondary|Patterns of Failure (i.e., Local, Regional, and Distant), Including Overall Survival (Death Due to Any Cause)||From registration to date of local failure, regional failure, distant failure, death or last follow-up||||||
123430|NCT00613080|Secondary|All Treatment-related Adverse Events Per NCI CTCAE v3.0 Preoperative, Postoperative, and Overall||Three timeframes: Start of treatment to surgery, Surgery to 3 months after the completion of postoperative chemotherapy and Combined||||||
123431|NCT00613080|Secondary|Pathologic Complete Response Rate||After protocol surgery||||||
123432|NCT00613080|Secondary|Intensity-modulated Radiotherapy (IMRT) Feasibility||IMRT planning and dosing data is centrally reviewed for quality assurance||||||
123433|NCT00613080|Primary|The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively|The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.|From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)|Eligible subjects who started study treatment.||percentage of patients||90% Confidence Interval|Number
123434|NCT00613028|Secondary|Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|Incidence of ≥Grade 3 treatment related, non-hematologic toxicity|41 months|||participants|||Number
123435|NCT00613028|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|41 months|||weeks||95% Confidence Interval|Median
123436|NCT00613028|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|41 months|||weeks||95% Confidence Interval|Median
123437|NCT00613028|Secondary|Radiographic Response|Percentage of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.|41 months|||percentage of participants|||Number
123438|NCT00613028|Primary|The Primary Outcome Measure is 6 Month Progression-free Survival.|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|||percentage of participants||95% Confidence Interval|Number
123439|NCT00613015|Secondary|Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure|Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.|Immediately following trier + cocaine cue exposure|||mcg/dl||Standard Deviation|Mean
123555|NCT00611559|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose|Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
123440|NCT00613015|Primary|Cocaine Craving- 2:30 pm, Immediately Following Trier + Cocaine Cue Exposure|Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.|Post Trier social stress task + Cocaine Cue|||units on a scale||Standard Deviation|Mean
123441|NCT00612924|Primary|Freedom From Major Adverse Events|"All-Cause Mortality~Myocardial Infarction (MI)~Cerebrovascular Accident (CVA)~Renal Failure~Respiratory Failure~Paralysis or Paraplegia, or~Bowel Ischemia"|30 days|||percentage of patients||95% Confidence Interval|Number
123442|NCT00612924|Secondary|Secondary Effectiveness, Technical Success|Introduction and deployment of the Stent Graft in the absence of mortality, conversion to surgical repair, failed patency of both limbs, and evidence of a Type I or III endoleak through the first 24 hour post-operative period.|24 hours|||participants|||Number
123443|NCT00612924|Primary|Successful Aneurysm Treatment|"defined as a composite endpoint of subjects who have successful delivery and deployment of the Anaconda™ Stent Graft at the initial procedure and at ≤365 days post-procedure and absence of:~Aneurysm growth ≥ 5 mm as evaluated by the core laboratory~Post-operative interventions to correct type I or III endoleaks~Conversion to open surgical repair~Failed patency of both limbs~Migration requiring secondary procedure or intervention~Significant fracture~Aneurysm rupture"|365 days|||percentage of patients||95% Confidence Interval|Number
123444|NCT00612807|Secondary|Beck Anxiety Inventory||pre-treatment, post-treatment, 6 month follow-up||||||
123445|NCT00612807|Secondary|Personal Assessment of Intimacy in Relationships||pre-treatment, post-treatment, 6 month-followup||||||
123446|NCT00612807|Secondary|SCID Mood Disorders||pre-treatment, post-treatment, 6 month follow-up||||||
123447|NCT00612807|Secondary|Conflict Tactics Scale||pre-treatment, post-treatment, 6 month follow-up||||||
123448|NCT00612807|Secondary|Frequency & Acceptability of Partner Behavior||Pre-treatment, post-treatment, 6 month follow-up||||||
123449|NCT00612807|Primary|Dyadic Adjustment Scale (DAS)|The DAS is a self-report measure of marital adjustment that includes questions about agreement on lifestyle and household decisions, level of conflict, level of cooperation, and affection. Scores range from 0 to 151, with higher scores representing better relationship functioning.|pre-treatment, monthly, post-treatment, 6 month follow-up|||Score on DAS measure||Standard Deviation|Mean
123450|NCT00612807|Primary|Hamilton Depression Rating Scale (HDRS)|The HDRS is a semi-structured interview administered by a trained independent evaluator, and used for rating the severity of depressive symptoms. Scores range from 0 to 50, with higher scores indicating greater severity of depression.|pre-treatment, monthly, post-treatment, 6 month follow-up|||Score on HDRS||Standard Deviation|Mean
123451|NCT00612690|Secondary|The Academic Competence Evaluation Scale (ACES)|The ACES is a teacher rating scale that describes a set of behaviors and attitudes measuring teachers’ perceptions of student's academic competence and performance. The scale consists of 30 items rated on a 5-point scale (1 = Never, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Almost Always). The total score was reported as a mean per item with higher scores indicating better academic competence. Scores could range from 1 to 30.|Measured at pre- and post-school year for 3 years|Only children with available data were included in the analyses.||units on a scale||Standard Deviation|Mean
123452|NCT00612690|Primary|Social Skills Rating System (Parent Report)|This rating scale was completed by parents to assess how frequently their child engaged in a range of disruptive, prosocial, and academic behaviors (0 = Never to 2 = Very Often). Normative data are provided by age and sex and the measure was standardized on a heterogeneous population of which one third were urban and 28% were minorities. The scale score, Social Skills, was the primary outcome measure. Scores are rated on a scale of 0 (Never) to 2 (Very Often). The scale score, Social Skills, containing 38 items, was the primary outcome measure. Scores range from 0 to 76 with higher scores indicating improved social skills.|Measured at pre- and post-school year for 3 years|Child participants with available data were included.||units on a scale||Standard Deviation|Mean
123453|NCT00612677|Secondary|Number of Participants Who Experienced Toxicities|We planned to determine the safety of the regimen (Drug Toxicities) assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.|||||
123454|NCT00612677|Secondary|Time to Progression (TTP)|We planned to calculate the median Time to Progression of all participants.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.|||||
123455|NCT00612677|Primary|Number of Patients Who Responded to Treatment|We planned to determine the Overall Response Rate (ORR = CR+PR) of this regimen according to RECIST Criteria.|Patient will continue study treatment until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 3 weeks.|Study closed before treatment started.|||||
123456|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population|Total Lesion Count is the sum of inflammatory and noninflammatory lesions.|Baseline to Week 12|ITT Population||Lesions||Standard Deviation|Mean
123457|NCT00612573|Secondary|Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population|Noninflammatory Lesion Count includes open and closed comedones.|Baseline to Week 12|ITT Population||Lesions||Standard Deviation|Mean
123458|NCT00612573|Primary|Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population|Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.|Baseline to Week 12|ITT Population||Lesions||Standard Deviation|Mean
123512|NCT00612040|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
123459|NCT00612573|Primary|Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population|IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.|Week 12|ITT Population||Percentage of Participants||95% Confidence Interval|Number
123460|NCT00612534|Primary|SPID-12|SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.|12 hours after first dose|One patient in Sufentanil NanoTab 10 mcg group received the incorrect treatment so was not included in efficacy analysis||units on a scale||Standard Error|Least Squares Mean
123461|NCT00612508|Secondary|Adverse Events|Self-reported treatment-related and serious adverse events|over 168 days|All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event||participants|||Number
123462|NCT00612508|Primary|Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.|Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days|baseline, 84 days, 168 days|"A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days).~The analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)"||mm||Standard Deviation|Mean
123463|NCT00612430|Secondary|Median Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|median of 91.4 weeks|||weeks||95% Confidence Interval|Median
123464|NCT00612430|Secondary|Median Progression-Free Survival|Time in weeks from the start of study treatment to the date of first progression, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Patients were followed for a median of 91.4 weeks|||weeks||95% Confidence Interval|Median
123465|NCT00612430|Secondary|Safety of Study Treatment Regimen|Number of participants experiencing a non-hematologic toxicity ≥ grade 3 that was possibly, probably, or definitely related to study treatment.|2 years|||participants|||Number
123466|NCT00612430|Secondary|Objective Response Rate|The percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required.|2 years|||percentage of participants|||Number
123467|NCT00612430|Primary|6 Month Progression-Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans.|6 months|||percentage of participants||95% Confidence Interval|Number
123468|NCT00612339|Primary|Response Rate|The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|4 months|All subjects||percentage of patients||95% Confidence Interval|Number
123469|NCT00612313|Primary|Remission|Remission is defined as CDRS-R <=28.|Measured at Weeks 12, 18, 24, and 30|||probability of remitting (%)|||Number
123470|NCT00612313|Secondary|Relapse|"Up through week 30, relapse was defined as:~1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration.~From week 31-78, relapse was assessed using the K-Life. Relapse was defined as at least 2 weeks of a K-Life rating of 5 or 6; participants may also be identified as relapsing with a K-Life rating of 4 if the rating was for several weeks and not strictly related to stressful life events."|Weeks 52 and 78|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.||Probability of Relapse (%)|||Number
123471|NCT00612313|Secondary|Remission|Remission is defined as CDRS-R <=28 (up through week 30) or at least 8 consecutive weeks of a K-Life rating of 1 or 2. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|Weeks 52 and 78|||Probability of remission (%)|||Number
123513|NCT00612040|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||mmol/L||Standard Deviation|Mean
123472|NCT00612313|Secondary|K-Life (Time Well)|"K-Life interview was conducted at Weeks 6, 12, 18, 24, and 30, with ratings for depressive illness for each week throughout the study.~Ratings definitions: 1=Normal, no residual symptoms; 2=Presence of 1 or more symptosm in no more than mild degree; 3=Considerably less psychopathology than full criteria, but still obvious evidence of disorder with no more than moderate impairment; 4=Does not meet full criteria, but has major symptoms or impairment from the disorder; 5=Meets full criteria, but no extreme impairment; 6=Meets full criteria, and either has prominent psychotic symptoms or extreme impairment.~Time well is defined as each week the depression rating was a 1 or 2. Percent time well was defined as each week the depression rating was a 1 or 2 divided by the total number of weeks in the study.~Statistic: anova"|30 weeks|||Weeks spent well||Standard Deviation|Mean
123473|NCT00612313|Primary|Relapse|"Relapse was defined as:~1) CDRS-R score >=40 with a history of 2 weeks of clinical deterioration or 2) CDRS-R<40, but with a 2 week history of significant clinical deterioration."|Measured at Weeks 12, 18, 24, and 30|Only participants who achieved remission were analyzed for relapse rates, as only remitted patients can experience a relapse of depression.||probability of relapse (%)|||Number
123474|NCT00612313|Primary|Time to Remission|Remission is defined as CDRS-R <=28. Timing of remission is based on clinical assessment using the CDRS-R and K-Life to identify the week at which point the patient remitted.|30 weeks|||weeks||Standard Error|Mean
123475|NCT00612222|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|15 months|||Participants|||Number
123476|NCT00612222|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.|||||
123477|NCT00612222|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met|||Participants|||Number
123478|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Unclassifiable"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants who could not be specifically differentiated in any of the other three subtypes were stratified as unclassifiable meaning that the participants could not be classified into any of the predefined PHN subtypes. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
123479|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Deafferentation Type 2 (D Type 2)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss and severe spontaneous burning pain without allodynia associated with reorganization of central nerve fibers were stratified in the “deafferentation type 2 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
123480|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) SubtypeDeafferentation Type 1 (D Type 1)"|"Participants stratified into 4 different PHN subtypes based on NPPE. Participants with marked sensory loss associated with severe burning pain upon slight mechanical stimuli (allodynia) were stratified in the deafferentation type 1 subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
123481|NCT00612105|Secondary|"Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype Irritable Nociceptors"|"Participants were stratified into four different PHN subtypes based on the NPPE. Participants with pain, abnormal sensitization of the specific receptor (irritable nociceptors), and with minimal sensory loss were stratified in theirritable nociceptors subtype. Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point NRS: 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain."|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. Only participants in the specified subgroup were analyzed.||Scores on a scale||Standard Deviation|Mean
123482|NCT00612105|Secondary|Number of Participants With Indicated Responses at the End of the MP to the Questions: “How Sharp Was the Affected Side Compared to the Opposite Side?” and “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Hyperalgesia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions:How sharp was the affected side compared to the opposite side? and How painful was the affected side compared to the opposite side?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
123483|NCT00612105|Secondary|Number of Participants With the Indicated Responses at the End of the MP to the Questions of “Is it Cool?” and “Is it Painful?” in an Assessment of Cold Threshold and Allodynia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
123484|NCT00612105|Secondary|Number of Participants With the Indicated Responses at the End of the MP to the Question: “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Tactile Allodynia|"At the end of the MP, the investigator conducted the NPPE (an examination of the effect of retigabine on sensory abnormalities) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side? End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP."|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
123485|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Questions: “How Sharp Was the Affected Side Compared to the Opposite Side?” and “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Hyperalgesia|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Hyperalgesia is defined as increased sensitivity to pain, which may be caused by damage to peripheral nerves. It was assessed with a pinprick brush, based on the questions: How sharp was the affected side compared to the opposite side? and How painful was the affected side compared to the opposite side?"|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Participants|||Number
123486|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Questions of “Is it Cool?” and “Is it Painful?” in an Assessment of Cold Threshold and Allodynia|"At Baseline the investigator conducted the NPPE to examine hyperalgesia and allodynia (tactile and cold). Cold threshold and allodynia was assessed to determine if a metal bar felt cool and if it felt painful, based on the questions:Is it cool? and Is it painful?"|Timeframe: Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Participants|||Number
123487|NCT00612105|Secondary|Number of Participants With the Indicated Responses at Baseline to the Question: “How Painful Was the Affected Side Compared to the Opposite Side?” in an Assessment of Tactile Allodynia|"At Baseline, the investigator conducted the Neuropathic Pain Physical Examination (NPPE) to examine hyperalgesia and allodynia (tactile and cold). Tactile allodynia was assessed with a foam brush, based on the question:How painful was the affected side compared to the opposite side?."|Baseline Phase (Day -7 to Randomization Day 0)|ITT Population - All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Participants|||Number
123488|NCT00612105|Secondary|Scores for Reported Health Transition at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|"The least square (LS) mean score for reported health transition was calculated based on the scores (ranging from 1 to 5) given by the participant in answer to the following question: Compared to 1 year ago, how would you rate your health in general now?”. Lower numbers represent a better state of health."|End of maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Error|Least Squares Mean
123489|NCT00612105|Secondary|Scores on the Medical Outcomes Short Form-36 (SF-36) at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP|Least square (LS) mean calculated based on participant's assessment of SF-36,a quality of life questionnaire consisting of 36 items grouped into 8 domains. These 8 domains further grouped into 2 overall summary measures,physical health and mental health. Higher scores on SF-36 represented better state of health. Physical/mental components summarized the data of all the physical/mental domains of SF-36 and higher scores represented better state of health.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Error|Least Squares Mean
123490|NCT00612105|Secondary|Scores on the Brief Pain Inventory-Short Form (BPI-SF) at the End of the MP for All Participants Who Completed Week-4 of the MP and Who Terminated Early During the MP|The BPI-SF assessed pain intensity, pain relief from medication, and pain interference with function over the previous 24 hours. Pain intensity was assessed by the mean of 4 intensity items rated on a 0-10 categorical scale: 0=no pain, 10=pain as bad as you can imagine. Pain interference was assessed by determining the mean of the 7 interference items on a 0-10 categorical scale ranging from 0=does not interfere to 10=completely interferes. The level of pain relief provided by treatment was assessed on an 11-point categorical scale ranging from 0% to 100%|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Deviation|Mean
123514|NCT00612040|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
123491|NCT00612105|Secondary|Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) at the End of the Maintenance Phase|The TSQM assessed the participant's overall satisfaction with treatment, including subscales to assess effectiveness, side effects, convenience, and global satisfaction. Raw scores from the scale were transformed into a numeric scale ranging from 0 to 100, where higher scores indicated greater satisfaction with treatment. TSQM was reported at the end of the MP. Participants who completed Week 4 of the MP and who terminated early during the MP were assessed.|End of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP. Differences from the overall population numbers are due to missing data or to participants missing visits.||Scores on a scale||Standard Deviation|Mean
123492|NCT00612105|Secondary|Number of Participants With the Indicated Overall Patient Global Impression of Change (PGIC)|For the PGIC assessment, participants were asked to assess their overall status since they initiated the study drug to the end of the Maintenance Phase using a 7-point categorical scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. All participants who completed Week 4 of the Maintenance Phase and participants who terminated early during the Maintenance Phase were assessed.|Baseline to the end of Maintenance Phase (MP) (Week 4)|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
123493|NCT00612105|Secondary|Number of Participants With the Indicated Change From Baseline to the End of the Maintenance Phase in Optimal Sleep Based on the Sleep Quantity Domain of the MOS Sleep Scale|"Optimal Sleep was based on the Sleep Quantity domain of the MOS Sleep Scale and included the options of Yes if sleep quantity was 7-8 hours, and No otherwise. Improved indicated a change in response of no at baseline to yes at the end of the MP, Same indicated no change in response, and Worse indicated a change in response from yes at baseline to no at the end of the MP."|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Participants|||Number
123494|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Sleep Quantity|Change from Baseline in sleep quantity was calculated by subtracting the average value of sleep quantity, calculated in hours, at the end of the MP from the average Baseline value.|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Hours||Standard Deviation|Mean
123495|NCT00612105|Secondary|Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Medical Outcomes Study (MOS) Sleep Scale Scores|Change from BL (average value of MOS Sleep Scale score including Overall Sleep Problem [OSP] Index at end of MP minus average BL value) to the end of the MP was summarized for the OSP Index, in addition to the following subscales of the MOS Sleep Scale: Sleep Disturbance; Sleep Adequacy; Snoring; Awakening with Shortness of Breath or with a Headache; Somnolence; and Optimal Sleep. Each item was transformed to a scale with a range of 0-100. For each subscale, except Optimal Sleep, higher scores indicate a greater level of what was being measured (i.e., more snoring, more sleep adequacy, etc.).|Baseline and End of Maintenance Phase (MP) (Week 4).|ITT Population includes all participants who entered MP and provided data. End of Maintenance Phase includes participants who completed Week 4 of the MP and who terminated early during the MP.||Scores on a scale||Standard Deviation|Mean
123496|NCT00612105|Secondary|Number of Participants Classified as Responders, With a 50% and 30% Pain Reduction From Baseline to the Last 7 Days of the Maintenance Phase|Responders were defined as participants achieving a mean >=50% or >=30% pain reduction based on the NRS score from Baseline to the last 7 days of the MP. Those participants who did not have at least 3 diary entries in the MP, those who withdrew during the Titration Phase (TP), and non-completers (NC: who did not complete the study) were classified as non-responders. The number of responders and responders including non-completers from Baseline to the last 7 days of the MP were reported.|Baseline and Week 4 Maintenance Phase (MP)|ITT Population. All participants providing data for this analysis had to have 7 available baseline diary entries.||Participants|||Number
123497|NCT00612105|Secondary|Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)|Least square mean (LSM) of pain intensity was calculated from the NRS score entered by the participants in their diaries at each week during the MP. Participants rated their pain during the previous 24 hours at all clinic visits using an NRS: 0, no pain; 1-3, mild; 4-6, moderate; 7-10 (worst possible pain), severe pain. Change from Baseline was calculated by subtracting the value of the average of the LSM of the NRS score at each week during the MP (the last 7 available diary entries in the MP were used, provided at least 3 existed) from the average Baseline value of the LSM of the NRS score.|Baseline and Weeks 1, 2, 3, and 4 (MP)|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Scores on a scale||Standard Deviation|Mean
123498|NCT00612105|Secondary|Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)|Participants recorded the number of acetaminophen tablets taken during the previous 24 hours in a participant diary. Rescue medication was summarized as the mean number of doses taken per day during each week of the Maintenance Phase (MP) and the mean number of doses taken during all MP weeks.|Weeks 1, 2, 3, and 4 Maintenance Phase|ITT Population. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Tablets/Day||Standard Deviation|Mean
123551|NCT00611559|Secondary|Anti-PRP Antibodies Concentration|Concentration of anti-PRP antibodies given as GMC in µg/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||µg/mL||95% Confidence Interval|Geometric Mean
123556|NCT00611559|Primary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123499|NCT00612105|Secondary|Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment|Participants rated their pain during the previous 24 hours at all clinic visits using an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain (10=worst possible pain). Change in In-clinic Pain Assessment was calculated by subtracting the average score on the NRS at Week 2 and Week 4 (values for each week were observed cases) of the MP from the average score on the NRS at Baseline (the last non-missing measurement prior to taking study drug).|Baseline and Weeks 2 and 4 (Maintenance Phase - MP)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy assessment. All participants providing data for the measure are included in the analysis. Differences from the overall population numbers are due to missing data or to subjects missing visits.||Scores on a scale||Standard Deviation|Mean
123500|NCT00612105|Primary|Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.|Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.|Baseline and Week 4 (Maintenance Phase-MP)|Per Protocol (PP) Population: all randomized participants who completed the Titration Phase, had at least 1 dose of treatment in the MP, had at least 3 diary entries in the MP, and did not have any protocol violations or any major protocol deviations||Scores on a scale||Standard Error|Least Squares Mean
123501|NCT00612066|Primary|Number of Responders|"Definition of Treatment Response~The primary outcome in Cushing's disease will the % responders, a responder is defined as a patient with 2 consecutive 24h urinary free cortisols within the normal reference range in association with no clinical signs of disease progression.~Secondary outcomes will include the % reduction in 24h UFC (derived by comparison of the mean of 2 baseline 24h UFC values with mean of the two lowest consecutive 24h UFC values while on study treatment in association with no clinical signs of disease progression)."|7 weeks|Sample size was too small to do a valid analysis.||participants|||Number
123502|NCT00612040|Secondary|Physical Examination|Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -1, Week 8, Week 16||||||
123503|NCT00612040|Secondary|Vital Signs: Pulse|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.||beats/minute||Standard Deviation|Mean
123504|NCT00612040|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
123505|NCT00612040|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 57 (SIBA E) and 57 (IGlar) subjects contributed to the analysis at week 16.||mmHg||Standard Deviation|Mean
123506|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.||umol/L||Standard Deviation|Mean
123507|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
123508|NCT00612040|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Laboratory values at screening (Week -1) and at Week 16|Week -1, Week 16|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 55 (SIBA D), 53 (SIBA E) and 54 (IGlar) subjects contributed to the analysis at week 16.||IU/L||Standard Deviation|Mean
123509|NCT00612040|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
123510|NCT00612040|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123511|NCT00612040|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123515|NCT00611897|Secondary|Mismatch Negativity (MMN) Duration|"Mismatch Negativity (MMN) Duration difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
123516|NCT00611897|Secondary|Mismatch Negativity (MMN) Frequency|"Mismatch Negativity (MMN) Frequency difference waves at midline electrodes (Fx, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
123517|NCT00611897|Primary|Novel P300|"The Novel P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
123518|NCT00611897|Secondary|Mismatch Negativity (MMN) Intensity|"Mismatch Negativity (MMN) Intensity difference waves at midline electrodes (Fz, Cz and Pz).~The frequent standard tones were of 75 ms duration with 5 ms rise and fall time, and were composed of 500, 1000, and 1500 Hz sinusoidal partials (harmonics) that resulted in a single high pitched beep sound.~All tones were presented at 76 dB sound pressure level (SPL) with the exception of intensity deviants. The three deviants were distinguishable from standard tones in either intensity, frequency, or duration.~Subjects performed a visual discrimination distractor task during the MMN runs and were instructed to ignore the tones.~The mismatch negativity (MMN) measure included 3 types of deviant tones (stimuli) that the subjects heard: 1. Frequency deviant, 2. Intensity deviant, 3. Duration deviant. The response to these 3 types of deviants were recorded in the EEG. Therefore each deviant was associated with different waves which we measured in amplitude (microvolts)"|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
123519|NCT00611897|Primary|Target P300|"The Target P300 measures were obtained from the Fz, Cz and Pz electrodes.~Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL."|daily|Per protocol||microvolts||Standard Error|Least Squares Mean
123520|NCT00611884|Secondary|Physical Examination|Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.|Week -4, Week 0, Week 8, Week 16||||||
123521|NCT00611884|Secondary|Vital Signs: Pulse|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||beats/minute||Standard Deviation|Mean
123522|NCT00611884|Secondary|Vital Signs: Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
123523|NCT00611884|Secondary|Vital Signs: Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 16|Week 0, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||mmHg||Standard Deviation|Mean
123524|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Serum Creatinine|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||umol/L||Standard Deviation|Mean
123525|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
123526|NCT00611884|Secondary|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)|Mean values at Week -4 and at Week 16|Week -4, Week 16|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||IU/L||Standard Deviation|Mean
123552|NCT00611559|Secondary|Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose|"Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL~Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes"|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123527|NCT00611884|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 16 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.||Events/100 years of patient exposure|||Number
123528|NCT00611884|Secondary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123529|NCT00611884|Secondary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 16 + 5 days follow up|The full analysis set (FAS) included all randomised subjects.||Episodes/100 years of patient exposure|||Number
123530|NCT00611884|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||mmol/L||Standard Error|Least Squares Mean
123531|NCT00611884|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 16 weeks of treatment|Week 0, Week 16|The full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).||percentage of glycosylated haemoglobin||Standard Deviation|Mean
123532|NCT00611806|Secondary|Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations||Measured at Week 16||||||
123533|NCT00611806|Secondary|Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype|The change from baseline on the Positive and Negative Syndrome Scale (PANSS) (including FOLH1, MTHRF, MTR, and COMT genotype simultaneously into a linear mixed model).The PANNS has three sub-scales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS negative and positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7 representing the negative and positive symptoms of schizophrenia, respectively, and the general psychopathology sub-scale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135) and agreed to the DNA blood draw (n = 120).||units on a scale||95% Confidence Interval|Mean
123534|NCT00611806|Secondary|Scale for Assessment of Negative Symptoms (SANS)|The change from baseline on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total SANS score per week, whereas a positive score represents an increase in total SANS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the SANS assessment was performed.||units on a scale||95% Confidence Interval|Mean
123535|NCT00611806|Secondary|Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.||units on a scale||95% Confidence Interval|Mean
123536|NCT00611806|Secondary|Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score||Measured at Week 16||||||
123553|NCT00611559|Secondary|Anti-HB Antibodies Concentration|Concentration of anti-HB antibodies given as GMC in mIU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||mIU/mL||95% Confidence Interval|Geometric Mean
123557|NCT00611559|Primary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123537|NCT00611806|Primary|Positive and Negative Syndrome Scale (PANSS)|The change from baseline on the Positive and Negative Syndrome Scale (PANSS).The PANNS has three subscales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7, representing positive symptoms of schizophrenia. The PANSS negative symptom subscale is comprised of 7 items rated on a scale of 1-7 representing the negative symptoms of schizophrenia, and the general psychopathology subscale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.|Baseline vs. Week 16|Participants analyzed were those who completed at least 1 post-baseline visit or more (n = 135). 120 participants completed the study to the week 16 endpoint; however, 15 participants did not complete the entire 16 weeks, but completed at least one post-baseline study visit where the PANSS assessment was performed.||units on a scale||95% Confidence Interval|Mean
123538|NCT00611715|Secondary|Number of Patients With Worst-grade Toxicities Per Grade|Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 24 weeks|All patients who received treatment and experienced an adverse event.||participants|||Number
123539|NCT00611715|Secondary|Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions.|at 24 weeks|Analysis population is patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.||participants|||Number
123540|NCT00611715|Secondary|Median Time to Progression of Target Lesions|Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Every 12 weeks from on-study to disease progression|Patients who were available for response measurement. Seven patients in the Hormone therapy naive arm did not meet the criteria for response evaluation. One patient in the Previous Hormone Therapy arm did not meet the criteria for response evaluation.||Months||Full Range|Median
123541|NCT00611715|Primary|Number of Patients With Pathological Complete Response.|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 24 weeks|Analysis population is patients who were available for response measurement. Some patients did not meet the criteria to be analyzed for response evaluation which accounts for the discrepancy in patients analyzed vs. total accrual population.||participants|||Number
123542|NCT00611559|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Up to one month after the booster dose administration|||subjects|||Number
123543|NCT00611559|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period|||subjects|||Number
123544|NCT00611559|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite|Within the 4-day (Day 0-3) post-vaccination period|||subjects|||Number
123545|NCT00611559|Secondary|Anti-poliovirus Antibodies Titer|Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||titer||95% Confidence Interval|Geometric Mean
123546|NCT00611559|Secondary|Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50|Before the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123547|NCT00611559|Secondary|Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose|Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
123548|NCT00611559|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose|Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123549|NCT00611559|Secondary|Anti-diphtheria and Anti-tetanus Antibodies Concentration|Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL|Before (Pre) and one month after (Post) the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||IU/mL||95% Confidence Interval|Geometric Mean
123550|NCT00611559|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL|Before the booster dose administration (at baseline)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123558|NCT00611559|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose|Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)|One month after the booster dose|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123559|NCT00611559|Primary|Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose|Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)|One month after the booster dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
123560|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Dose-Normalized AUC)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.||ng*h/mL||Standard Deviation|Mean
123561|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Renal Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. However, only 13 were able to be analyzed for the renal clearance because in 5 patients the amount of topotecan measured in the urine was more than the topotecan dose that was given. Renal clearance was not calculated for those patients.||L/h/m^2||Standard Deviation|Mean
123562|NCT00611468|Primary|Pharmacokinetic Parameters of Intravenous Topotecan With and Without Erlotinib (Mean Clearance)||Day 1 Week 1 and Day 1 Week 3|Of the 29 consenting patients, 18 provided information that could be used in the analysis. 1 patient withdrew, 2 had samples that were inevaluable due to lab error, and 8 went off study before receiving topotecan with erlotinib.||L/h/m^2||Standard Deviation|Mean
123563|NCT00611468|Primary|Dosage Limiting Toxicities||DLT were assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21)|DLT were assessed using NCI CTCAE version 3.0. After MTD was determined, 13 additional patients were enrolled to enhance estimation of PK parameters. The first 8 were enrolled at dose 2. Because 4 of these patients experienced a DLT, the remaining 5 patients were enrolled at dose level 1. Of these, 1 experienced a DLT.||Participants|||Number
123564|NCT00611468|Secondary|Objective Response (as Determined Using RECIST 1.0 Criteria)||Every 6 weeks until the end of study treatment|After the determination of MTD, an additional 13 patients were enrolled to enhance estimation of PK parameters. The first 8 patients were enrolled at dose level 2, 4 of whom experienced a DLT. Thus, the remaining 5 patients were enrolled at dose 1. One of these patients experienced a DLT.||Participants|||Number
123565|NCT00611468|Secondary|Pharmacogenetic Analysis (CYP3A4/5 Polymorphisms, UGT1A1, BCRP, and MDR1 Genotypes)|Each subgroup lists the gene on which a polymorphism occurred (e.g., CYP3A4), the name of the polymorphism (e.g., *1), whether it was heterozygous or a variant, the number of subjects with available data, and the number who had the polymorphism.|Baseline|Pharmacokinetic studies were done for all 29 consenting patients (one of whom later withdrew).||Participants|||Number
123566|NCT00611468|Primary|Maximum Tolerated Dosage (MTD) of Intravenous Topotecan When Given in Combination With Oral Erlotinib|The MTD of topotecan was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first cycle of combination topotecan and erlotinib therapy (days 1-21).|DLT information was available for 3 patients who received a topotecan dose of 0.75 mg/M^2, for 6 patients who received a topotecan dose of 1.0 mg/M^2, and for 6 patients who recived a topotecan dose of 1.25 mg/M^2. 1 additional patient received a dose 1.0 mg/M^2 but withdrew before completing cycle 1. This patient had no DLT and was replaced.||mg/m^2|||Number
123567|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
123568|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; Creatinine: N/A, 1.2; CO2/BCO: 0.85/0.75, 1.2/1.3; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
123569|NCT00611455|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicated the presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124417|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding||Through 30days following PPCI|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
123570|NCT00611455|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Months||Full Range|Median
123571|NCT00611455|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123572|NCT00611455|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.||Participants|||Number
123573|NCT00611455|Secondary|Number of Participants With the Indicated Biomarker Data Outside the Reference Range at Baseline or Any Post-Baseline Visit During the DB and OL Periods by Ofatumumab Treatment Course (TC)|Only those parameters for a particular flag (<LLN or >ULN) are summarized if at least one value was outside the specified reference range. The Baseline (BL) value for a TC was defined as the latest value on or before the date of infusion A of the TC. However to be evaluable as a baseline value, assessments must have been conducted within a 14 day window prior to the date of infusion A. The post-baseline (PBL) was any visit after the date of infusion A during the specified TC. The pre-defined LLN for biomarkers are: B-lymphocyte stimulator (B-ls):<486.5 nanograms per Liter (ng/L); Interleukin-6 (IL-6):<0.31ng/L and Serum amyloid A: <1951 ng/mL. LLN was not defined for Rheumatoid factor (RF)-IgA, RF-IgG, RF-IgM or anti- cyclic citrullinated peptide (CCP) antibody and RF. The pre- defined ULN range for biomarkers (RF)-IgA: >6 units; RF-IgG:>6 units; RF-IgM:>6 units; Anti-CCP:>19.9999 units; B-ls:>1343.3 ng/L; IL-6: >5 ng/L; RF:>11.9999 kilounits (KU)/L; Serum amyloid A:>82432 ng/mL.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123574|NCT00611455|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Lymphocytes: 0.4, 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.75, 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123575|NCT00611455|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Baseline (BL) value for a treatment course (TC) is defined as the latest value on or before the date of infusion A of the TC. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified TC. Pre-defined limits of potential CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85/0.75, 1.2/1.3, ; Chloride: 0.9, 1.1; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Lactate dehydrogenase (LDH): NA, 2; Potassium: 0.9, 1.1; Sodium: 0.93, 1.07; Total protein: 0.8, 1.15; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123576|NCT00611455|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123577|NCT00611455|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123578|NCT00611455|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123579|NCT00611455|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123580|NCT00611455|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123581|NCT00611455|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
123582|NCT00611455|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population||Participants|||Number
123583|NCT00611455|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants who were retreated from Week 24 were analyzed.||Weeks||Standard Deviation|Mean
123584|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
123585|NCT00611455|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
123593|NCT00611455|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Error|Least Squares Mean
123586|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
123587|NCT00611455|Secondary|Minimum Change From Baseline in the DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
123588|NCT00611455|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
123589|NCT00611455|Secondary|Minimum DAS28-ESR Score During the Double-blind (DB) and Open-label (OL) Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period. Only those participants contributing values at the indicated time point were analyzed.||Scores on a scale||Standard Deviation|Mean
123590|NCT00611455|Secondary|Change From Baseline in Levels of IL-6 and Serum Amyloid A at Week 24|The following biomarkers were assessed: Interleukin 6 (IL-6) and Serum Amyloid A. These biomarkers were used to further characterize disease activity.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||nanogram per liter (ng/l)||Full Range|Median
123591|NCT00611455|Secondary|Change From Baseline in Levels of Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Week 24|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||Units/Liter||Full Range|Median
123592|NCT00611455|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
123623|NCT00611325|Secondary|Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities|Number of patients with grade 3 or greater, treatment-related, non-hematologic toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|60 months|||participants|||Number
124730|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 6.5%|Percentage of ITT patients who had achieved HbA1c <= 6.5% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||percentage of participants|||Number
123594|NCT00611455|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Error|Least Squares Mean
123595|NCT00611455|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||millimeters per hour (mm/hr)||Full Range|Median
123596|NCT00611455|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from Baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||milligrams per liter (mg/L)||Full Range|Median
123597|NCT00611455|Secondary|Change From Baseline in HAQ-DI Score at Week 24|The self-assessed HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Change from baseline was calculated as the value at Week 24 minus the baseline value.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
123598|NCT00611455|Secondary|Change From Baseline in the Physician-assessed Global Disease Score at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
123599|NCT00611455|Secondary|Change From Baseline in Participant-assessed Global Disease Score at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
123600|NCT00611455|Secondary|Change From Baseline in the Participant-assessed Pain Score at Week 24|"A horizontal VAS of 100 mm was used to report the participant’s level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Full Range|Median
123601|NCT00611455|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||number of swollen joints||Full Range|Median
123602|NCT00611455|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||number of tender joints||Full Range|Median
123603|NCT00611455|Secondary|Number of Participants With Clinical Remission at Week 24|Participants achieving clinical remission were defined as those with a low disease activity, i.e., DAS28 score (using CRP) <2.6 at Week 24.|Week 24|ITT Population||participants|||Number
123663|NCT00610714|Secondary|Progression-free Survival (PFS) as Evaluated by RECIST|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Analysis was based on August 31, 2009 data cut-off (78 PFS events analysis) and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg.|Date of randomization to earliest date of objective disease progression or death due to any cause (conducted when a minimum of 78 progression free survival events had occurred)|||Months||Full Range|Median
123604|NCT00611455|Secondary|Number of Participants Classified as Responders at Week 24 According to the Self-Assessed Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Week 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||participants|||Number
123605|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||participants|||Number
123606|NCT00611455|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||participants|||Number
123607|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
123608|NCT00611455|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
123609|NCT00611455|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of RA disease activity that combines information from swollen joints, tender joints, the acute phase reactant, and general health (patient global assessment). Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
123610|NCT00611455|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using LOCF. Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
123611|NCT00611455|Secondary|Median ACRn at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percent (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = minimum(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Missing data were imputed using last observation carried forward (LOCF). Analysis included those participants in the ITT Population with at least one post-baseline efficacy assessment.||percent change||Full Range|Median
123688|NCT00610441|Secondary|Computerized Cognition Assessment: Sustained Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of sustained attention (score range -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for sustained attention.||score on a scale||Standard Deviation|Mean
123612|NCT00611455|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
123613|NCT00611455|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
123614|NCT00611455|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population||participants|||Number
123615|NCT00611455|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.||participants|||Number
123616|NCT00611442|Secondary|The Number of Polyps Detected on Examination|The number of colon polyps detected during the colonoscopy.|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)|||number of polyps|||Number
123617|NCT00611442|Secondary|Procedure Time|Procedure time refers to the total length of time required to complete the colonoscopy|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)|||minutes||Standard Deviation|Mean
123618|NCT00611442|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.|measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)|||linkert scale (1-5)||Standard Deviation|Mean
123619|NCT00611442|Primary|The Overall Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0–4), as well as a global 3-point rating for overall colonic fluid (0–2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0–3, a good preparation 4–6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11–14, depending on the amount of colonic fluid|measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)|||Ottawa Score||Full Range|Mean
123620|NCT00611403|Secondary|Change From Baseline in Goblet Cell Density of the Eyes at Month 6|Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).||Cells per square millimeter (cells/mm^2)||Full Range|Median
123621|NCT00611403|Secondary|Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6|Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).|Baseline, Month 6|Intent-to-Treat (ITT). The ITT population includes all patients who started the study (randomized).||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
123622|NCT00611403|Primary|Percentage of Patients With Clinical Success at Month 6|Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.|Month 6|Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of < 25 mm in the 3 central regions of the eye on Day 2.||Percentage of Patients|||Number
125647|NCT00593606|Primary|Change in Inorganic Phosphate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
123624|NCT00611325|Secondary|Radiographic Response Rate|The percentage of participants with a complete or partial response at any assessment as determined by the Macdonald criteria. A confirmation of response was not required. Per Macdonald criteria, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions, no new lesions and stable or decreasing steroid dose. Objective response =CR+PR. Tumor assessments were done at baseline and at the end of each 6 week treatment cycle, and overall best response was recorded.|60 months|||percentage of participants||95% Confidence Interval|Number
123625|NCT00611325|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause. Assessed up to 60 months.|||months||95% Confidence Interval|Median
123626|NCT00611325|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression or death. Assessed up to 60 months.|||months||95% Confidence Interval|Median
123627|NCT00611325|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the initiation of treatment without progression of disease. PFS was defined as the time from the initiation of treatment to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Per Macdonald, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months|||percentage of participants||95% Confidence Interval|Number
123628|NCT00611247|Secondary|Toxicity Profile: Individual Subjects With Drug-related SAEs||12 months|||participants|||Number
123629|NCT00611247|Secondary|Toxicity Profile: Total Number of Drug-related Serious Adverse Events||12 months|||events|||Number
123630|NCT00611247|Primary|Response Rate (CR + CRi + LFS)|"Response determined per European LeukemiaNet response criteria:~CR = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 10e9/L; platelet count > 100 x 10e9/L; and independence of red cell transfusions.~CRi = all CR criteria except for residual neutropenia (< 1.0 x 10e9/L) or thrombocytopenia (< 100 x 10e9/L)].~Morphologic leukemia-free state (LFS) = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; with no hematologic recovery required.~Relapse = bone marrow blasts >5%; reappearance of blasts in the blood; or development of extramedullary disease."|up to 2 months|||participants|||Number
123631|NCT00611130|Post-Hoc|Medication Compliance|Using retained urine samples and prior to unblinding, up to 12 specimens/ subject were analyzed for vigabatrin levels. Compliance assessment based on > or = 70% of urines in subjects assigned to vigabatrin having quantitative levels of vigabatrin indicaticative of taking drug within the last 24 hours of clinic visit.|Week 2, 4, 6 & 9-11|Completers were defined as those who attended the scheduled Week 13 visit or the third visit of Week 12 and who also had provided urines during Weeks 11 & 12.||participants|||Number
123632|NCT00611130|Primary|Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.|Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.|Week 13|intent-to-treat||participants|||Number
123633|NCT00611026|Post-Hoc|Post-hoc Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a clinical investigation in which the participant was administered a product or medical device; the event does not necessarily need to have a causal relationship with the treatment or usage.|Baseline up to Week 12|Safety population included all participants who were randomized and received at least 1 dose of study treatment. N=number of participants with AEs noted in other unreviewed medical chart records as performed at other departments during the clinical trial but were not included as AEs in Case Report Forms; reported post-hoc.||events|||Number
123634|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12|"HRQL domain and total raw score derived as sum of scores (6-point scale:~1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement."|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
123635|NCT00611026|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.|Baseline, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
123636|NCT00611026|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.|Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||participants|||Number
125356|NCT00594854|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.|6 months|||Participants|||Number
123637|NCT00611026|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||participants|||Number
123638|NCT00611026|Secondary|Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary|Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing baseline and respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percentage of participants|||Number
123639|NCT00611026|Secondary|Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)|Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
123640|NCT00611026|Secondary|Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||scores on a scale||Standard Error|Least Squares Mean
123641|NCT00611026|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours|Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
123642|NCT00611026|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours|Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||severe urgency episodes per 24 hours||Standard Error|Mean
123643|NCT00611026|Secondary|Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
123644|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)|Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline urgency episodes >0 per 24 hours and non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||episodes per 24 hours||Standard Error|Least Squares Mean
123645|NCT00611026|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours|"UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is~1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100."|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
123646|NCT00611026|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4|FAS; (n)=number of participants with baseline UUI >0 per 24 hours and non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [LOCF] for placebo, tolterodine ER, and fesoterodine, respectively.||episodes per 24 hours||Standard Error|Mean
125648|NCT00593606|Primary|Change in Glucose|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
123647|NCT00611026|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
123648|NCT00611026|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours|Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with baseline nocturnal micturitions >0 per 24 hours and non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
123649|NCT00611026|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||percent change||Full Range|Median
123650|NCT00611026|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||micturitions per 24 hours||Standard Error|Least Squares Mean
123651|NCT00611026|Secondary|Change From Baseline in Mean Voided Volume Per Micturition|Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of participants with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [Last Observation Carried Forward (LOCF)], or Week 12 [LOCF]) for placebo, tolterodine ER, and fesoterodine, respectively.||mL||Standard Error|Mean
123652|NCT00611026|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 12|Full analysis set (FAS): at least 1 dose of assigned treatment, data for at least 1 baseline or post-baseline efficacy assessment, and excluded 77 participants from 3 study sites with Good Clinical Practices (GCP) deviations (Fesoterodine N=30, Tolterodine ER N=31, Placebo N=16). Decision to exclude that data was made while the study was blinded.||episodes per 24 hours||Standard Error|Mean
123653|NCT00610987|Primary|Number of Participants With Total Wound Infections|The primary endpoint was infection.|at 10-14 days, six weeks, 12 weeks, and every six to eight weeks thereafter until bony union occurs.|||participants|||Number
123654|NCT00610883|Primary|Complete Remission|The number of patients who achieved a complete remission as a result of treatment|330 Days|||participants|||Number
123655|NCT00610857|Secondary|Median Overall Survival (Point Estimate)|Median overall survival is the (point) estimate of the time corresponding to 50% estimated probability of survival.|Up to 44 months|||months||95% Confidence Interval|Median
123656|NCT00610857|Secondary|1-year Overall Survival (OS)|1-year survival is the estimated probability of surviving one year expressed as a percent (probability of survival is not probability of dying).|Time from initial treatment date, up to 1 year|||percentage of patients||95% Confidence Interval|Number
123657|NCT00610857|Secondary|Progression-free Survival (PFS)|Time from initial treatment date of to date of documented progression of disease progression (TTP)|Up to 44 months|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy||months||95% Confidence Interval|Median
123658|NCT00610857|Primary|Best Objective Response Rate (BORR)|Intention to treat response rate is estimated by the proportion of patients with a best response of CR, PR, or SD by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.0|Up to 44 months|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks||percentage of patients||90% Confidence Interval|Number
123659|NCT00610740|Secondary|Number of Patients With Measurable Peripheral Vein Concentration of dFdC|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood|30, 60, 90 minutes post uterine vein sample|||Participants|||Number
123660|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by local (uterine vein) gemcitabine hydrochloride concentration levels in blood|30 minutes post administration|||Participants|||Number
123661|NCT00610740|Primary|Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)|Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.|30 Minutes After Application of Gemcitabine|||Participants|||Number
123662|NCT00610714|Secondary|Overall Survival (Number of Deaths)|Interval between date of randomization and death due to any cause. Analysis was based on January 31, 2010 data cut-off and was performed with patients in ITT analysis set who received AZD0530 175mg or Placebo 175mg. At this time, data were still immature and median overall survival was not reached. Number of deaths is presented instead|Date of randomization to death due to any cause|||Participants|||Number
123664|NCT00610714|Primary|Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST)|Number of responders (complete (CR) or partial (PR) responders). CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diamete. Analysis was based on August 31, 2009 data cut-off , and was performed with patients who had measurable disease and received AZD0530 175mg or Placebo 175mg.|Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred)|||Participants|||Number
123665|NCT00610701|Primary|Quadriceps Strength|measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose|(admission, 6 weeks, 3 months, 6 months) 1 year|||Nm||Standard Deviation|Mean
123666|NCT00610688|Secondary|Birthweight of Newborn Infant|Growth of the Newborn Infant as Measured by Birthweight in grams.|Measured at birth.|||Grams||Standard Deviation|Mean
123667|NCT00610688|Secondary|Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth|Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth|At delivery|||cm||Standard Deviation|Mean
123668|NCT00610688|Primary|Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement|Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement|29 weeks|Intention to treat analysis.||nmol/L||Standard Error|Mean
123669|NCT00610675|Secondary|Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52|Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Units on a scale||Standard Deviation|Mean
123670|NCT00610675|Secondary|Change From Baseline in Quality of Sleep Scale at Week 52|Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Units on a scale||Standard Deviation|Mean
123671|NCT00610675|Secondary|Change From Baseline in Number of Awakenings at Week 52|Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Awakenings||Standard Deviation|Mean
123672|NCT00610675|Secondary|Change From Baseline in Wake Time After Sleep Onset at Week 52|Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Minutes||Standard Deviation|Mean
123673|NCT00610675|Secondary|Change From Baseline in Sleep Latency at Week 52|Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged.|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Minutes||Standard Deviation|Mean
123674|NCT00610675|Secondary|Change From Baseline in Total Sleep Time at Week 52|"Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question How much time did you actually spend sleeping?. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged."|Baseline and Week 52|AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary||Minutes||Standard Deviation|Mean
123675|NCT00610675|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to 52 weeks|AST population consisting of all enrolled participants who received at least one dose of trial medication||Participants|||Number
123676|NCT00610675|Primary|Number of Participants With an Adverse Event|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to 57 weeks|All subjects treated (AST) population consisting of all enrolled participants who received at least one dose of trial medication||Participants|||Number
123677|NCT00610649|Secondary|Part 2: Change From Baseline in the MADRS|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 28)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).||score on a scale||Standard Deviation|Mean
123678|NCT00610649|Secondary|Part 1: Change From Baseline in the Montgomery-Ashberg Depression Rating Scale (MADRS)|The MADRS is a 10-item scale designed to assess the severity of depression. The questionnaire includes questions on the following symptoms: Apparent sadness, Reported sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimistic thoughts, and Suicidal thoughts. Each of the 10 symptoms are rated on a scale of 1 to 6, with 1=absent to 6=severe. The MADRS score can range from 0 (symptoms absent) to 60 (severe depression), with a higher score indicating more severe depression.|Baseline and end of treatment (Up to Day 16)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||score on a scale||Standard Deviation|Mean
123679|NCT00610649|Primary|Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 28 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
123680|NCT00610649|Primary|Part 2: Number of Participants With AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 7 days following the last dose of study drug (Up to 35 days)|The AST population consisted of all Part 2 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
123681|NCT00610649|Primary|Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Discontinuation refers to discontinuation of study drug (MK-8777 or Placebo).|Up to the last dose of study drug (Up to 16 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
123682|NCT00610649|Primary|Part 1: Number of Participants With Serious Adverse Events (SAEs)|An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 30 days following the last dose of study drug (Up to 46 days)|The AST population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
123683|NCT00610649|Primary|Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. A moderate intensity AE is defined as an AE that causes no significant interference with functioning.|Up to 7 days following the last dose of study drug (Up to 23 days)|The All Subjects Treated (AST) population consisted of all Part 1 participants who received at least one dose of study drug (MK-8777 or Placebo).||participants|||Number
123684|NCT00610532|Primary|Quantitative EEG Recordings||end of each treatment|No data was analyzed because the study was terminated by the investigators after they decided not to continue the project|||||
123685|NCT00610441|Secondary|Computerized Cognition Assessment: Working Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of working memory (score range: -48 to 48), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for working memory.||score on a scale||Standard Deviation|Mean
123686|NCT00610441|Secondary|Computerized Cognition Assessment: Visual Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of visual memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for visual memory.||score on a scale||Standard Deviation|Mean
123687|NCT00610441|Secondary|Computerized Cognition Assessment: Verbal Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of verbal memory (score range: -60 to 60), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for verbal memory.||score on a scale||Standard Deviation|Mean
125435|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-fourth treatment treatment|Safety||cm||Full Range|Median
123689|NCT00610441|Secondary|Computerized Cognition Assessment: Reasoning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reasoning (score range: -15 to 15), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reasoning.||score on a scale||Standard Deviation|Mean
123690|NCT00610441|Secondary|Computerized Cognition Assessment: Reaction Time|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of reaction time (lowest time possible is 0 msec), with a lower reaction time indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for reaction time.||msec||Standard Deviation|Mean
123691|NCT00610441|Secondary|Computerized Cognition Assessment: Speed of Processing|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of speed of processing (score range: -1000 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for speed of processing.||score on a scale||Standard Deviation|Mean
123692|NCT00610441|Secondary|Computerized Cognition Assessment: Executive Functioning|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of executive functioning (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for executive functioning.||score on a scale||Standard Deviation|Mean
123693|NCT00610441|Secondary|Computerized Cognition Assessment: Composite Memory|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of composite memory (score range: -120 to 120), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for composite memory.||score on a scale||Standard Deviation|Mean
123694|NCT00610441|Secondary|Computerized Cognition Assessment: Complex Attention|Cognition was assessed by a computerized cognitive testing battery consisting of neuropsychological tests that measure the cognitive domain of complex attention (score range: 0 to 250), with a lower score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for complex attention.||score on a scale||Standard Deviation|Mean
123695|NCT00610441|Secondary|Computerized Cognition Assessment: Cognitive Flexibility|Cognition was assessed by a computerized cognitive testing (©CNS Vital Signs, Chapel Hill, NC) battery consisting of neuropsychological tests that measure the cognitive domain of cognitive flexibility (score range: -200 to 200), with a higher score indicating better cognition.|Baseline, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline computerized cognition efficacy assessment for cognitive flexibility.||score on a scale||Standard Deviation|Mean
123696|NCT00610441|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Score|The TASS is a participant-administered scale to assess study drug effects in the evening. Participants respond to 18 questions about ADHD symptoms, with scores from 0=Not at all to 3=Severe. Total scores can range from 0 to 54, with a higher score indicating more severe ADHD symtoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline TASS efficacy assessment.||score on a scale||Standard Deviation|Mean
123697|NCT00610441|Secondary|Change From Baseline in Quick Inventory of Depression Symptomology - Clinician Rating (QIDS-C) Score|The QIDS-C is a clinician-administered rating scale to measure the severity of depressive symptoms within the 9 DSM-IV major depression disorder symptom (MDD) domains: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. There is one score (0=none to 3=severe) for each of the of the 9 domains. The total score is obtained by adding the scores for each of the 9 symptom domains. QIDS-C total scores can range from 0 to 27, with a higher score indicating more severe depression. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline QIDS-C efficacy assessment.||score on a scale||Standard Deviation|Mean
123698|NCT00610441|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score|The PSQI is a participant-rated scale to assess the quality of sleep. The PSQI consists of 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score can range from 0=better (i.e., 0 times per month) to 3=worse (i.e., 3 or more times per week). The sum of these 7 component scores yields one total score with a range of 0 (better) to 21 (worse). A total PSQI score <=5 is associated with good sleep quality; a total score >5 is associated with poor sleep quality. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline PSQI efficacy assessment.||score on a scale||Standard Deviation|Mean
123699|NCT00610441|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Score|The ESS is an 8-item scale used to assess sleepiness. The test consists of a list of 8 situations in which participants rate their tendency to become sleepy on a scale of 0=Would never doze to 3=High chance of dozing. The scores for each of the 8 situations are added to create a total score on a scale with a range from of 0 to 24. A higher score indicates a greater degree of sleepiness. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2.|Baseline and Day 7, Day 14, Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline ESS efficacy assessment.||score on a scale||Standard Deviation|Mean
123700|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Improvement (CGI-I) Scores|The CGI-I is a 7-point clinician-rated scale for assessing the global improvement of ADHD. Scores could range from 1=Very much improved to 4=No change to 7=Very much worse, with a lower score indicating the most improvement. Analysis of CGI-I was performed using a proportional odds model. For statistical analyses, CGI-I assessments were condensed to one assessment of improvement per treatment period by taking the worst improvement score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-I efficacy assessment.||percentage of participants|||Number
123701|NCT00610441|Secondary|Percentage of Participants With Clinician Global Impression Scale - Severity (CGI-S) Category Scores|The CGI-S is a 7-point clinician-rated scale for assessing the global severity of ADHD. Scores could range from 1=Normal, not at all ill to 7=Among the most extremely ill, with a higher score indicating more severe illness. Categorization was as follows: 1=Normal, not at all ill and Borderline mentally ill; 2=Mildly ill; 3=Moderately ill and 4=Markedly ill, Severely ill and Among the most extremely ill patients, with a higher category indicating more severe illness. Analysis of CGI-S was performed using a proportional odds model. For statistical analyses, CGI-S assessments were condensed to one assessment of severity per treatment period by taking the most severe score at the second and third visits within a treatment period.|Days 14-21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline CGI-S efficacy assessment.||percentage of participants|||Number
123702|NCT00610441|Secondary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to last dose of study drug (Up to 56 days)|The AST population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).||percentage of participants|||Number
123703|NCT00610441|Secondary|Percentage of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. AEs are reported by study drug taken at time of event and not by randomly assigned sequence.|Up to 7 days after last dose of study drug (Up to 63 days)|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of randomized study drug within at least one of the two treatment periods (excluding the placebo run-in period).||percentage of participants|||Number
123704|NCT00610441|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the DSM-IV diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.||percentage of participants|||Number
123705|NCT00610441|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in AISRS Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. Reduction was defined as the relative change from the baseline score within a treatment period to post-baseline score within that treatment period.|Baseline and Day 21|The ITT population consisted of all participants who were randomized, who received at least one dose of study drug, and who had at least one postbaseline AISRS efficacy assessment.||percentage of participants|||Number
123718|NCT00610155|Secondary|State and Trait Anxiety Questionnaire|Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant report how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very much so). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 20-80 for each scale. Higher scores indicate more impaired participants.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
123940|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.~The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
123706|NCT00610441|Primary|Change From Baseline in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician-rated instrument for assessing the 18 core symptoms of ADHD corresponding to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnostic symptoms for adults. Based on the clinician’s rating for each of the symptoms using a 4-point scale (0=None to 3=Severe), the AISRS total score is derived by summing the score assigned to each of the 18 symptoms. Scores can range from 0 to 54, with a higher score indicating a more severe ADHD symptoms. Baseline was defined as the score at the baseline visit prior to starting dosing for Period 1 and as the last score in the 2-week placebo wash-out period for Period 2. For the statistical analyses, the average score from Day 14 and Day 21 was used.|Baseline (BL) and Day 7, Day 14, Day 21|The Intent-to-Treat (ITT) population consisted of all participants who were randomized, who received at least one dose of study drug in at least one period, and who had at least one postbaseline AISRS efficacy assessment. Results are reported by the study drug being administered at time of assessment and not by randomly assigned sequence.||score on a scale||Standard Deviation|Mean
123707|NCT00610311|Secondary|Number of Participants Who Develop Anti-mouse T Cell Receptor (TCR) Antibodies|Blood samples are collected from the patient and an immunological test is conducted in the laboratory to determine if the patient has generated antibodies against the mouse T-cell receptor which is part of the anti-gp100 cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.|||||
123708|NCT00610311|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18.5 months|||Participants|||Number
123709|NCT00610311|Secondary|Number of Participants With in Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells.|T cell receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|1 month|This outcome measure was not done because the study was terminated due to low accrual.|||||
123710|NCT00610311|Primary|Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)|Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module.|4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met|||Participants|||Number
123711|NCT00610207|Primary|Fistula Closure (Tract Based)|"Fistula closure is defined as absence of drainage at the external fistula opening.~An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient."|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.||tracts|Participants||Number
123712|NCT00610207|Primary|Fistula Closure (Patient Based)|Fistula closure is defined as absence of drainage at the external fistula opening.|12 months|Three single tract fistula patients were lost to follow-up and were excluded from the analysis.||participants|||Number
123713|NCT00610155|Secondary|Doleur Neuropathic 4 (DN4) Score|DN4 questionnaire provides a simple diagnosis of Neuropathic pain (NeP) by asking for yes/no answers to 4 questions (10 sub questions in total). Each question was scored on a scale of 0 (No) and 1 (Yes). Total score was calculated as sum of the 10 individual questions. Total score range 0-10, higher score indicated more neuropathic pain.|Day -35|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
123714|NCT00610155|Secondary|Present Pain Intensity Score (PPIS)|Participants answered: “Please rate your pain from 0-10 that best describes the intensity of pain right now”. PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).|Day 8, 22, 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
123715|NCT00610155|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated.|Day -35 through Day 36|FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
123716|NCT00610155|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicate a greater intensity of pain.|Baseline (Day -7), Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
123717|NCT00610155|Secondary|Pain Catastrophising Scale (PCS)|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores indicate greater extent of pain catastrophizing.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
123719|NCT00610155|Secondary|Beck Depression Inventory (BDI)|BDI is a 21 item participant rated inventory evaluating depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicate more depression.|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
123720|NCT00610155|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Day 8, 22, 36|Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.|||||
123721|NCT00610155|Primary|Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions|Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG.|Day 8, 22, 36|Data was not analyzed since these methods were not technically robust enough to make any clear conclusions.|||||
123722|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)|BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only.|Day 8, 22, 36|For VIS, based on preliminary analysis results, it was not considered significant to collect data according to Investigator's opinion.|||||
123723|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.||percent signal change||Standard Error|Least Squares Mean
123724|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)|BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.||percent signal change||Standard Error|Least Squares Mean
123725|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)|BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change).|Day 8, 22, 36|BOLD analysis set included all participants who completed all the 3 treatment periods of the study.||percent signal change||Standard Error|Least Squares Mean
123726|NCT00610155|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain|BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).|Day 8, 22, 36|Data not available to report, as BOLD brain activation signals in whole brain were obtained as specific Contrast Parameter Estimates (COPE) images only, as per planned analysis.|||||
123727|NCT00610129|Primary|Objective Response Rate (ORR)|in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.|2 years|||participants|||Number
123728|NCT00609986|Secondary|Severe Hyperglycemia|Blood glucose greater than 350 mg/dl.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
123729|NCT00609986|Primary|Acute/Active Rejection|Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology.|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
123730|NCT00609986|Secondary|Severe Hypoglycemia|Blood glucose less than 40 mg/dl|30 months|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
123731|NCT00609986|Primary|Delayed Graft Function|Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.|10 days|The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.||participants|||Number
123732|NCT00609973|Secondary|Endoscopic Recurrence Under Postoperative Treatment With Study Medication at 6 Months||6 months|Endoscopy 6 months, Intention-to-Treat analysis, patients not undergoing endoscopy were assumed to have endoscopic recurrence||participants|||Number
123733|NCT00609973|Primary|Safety and Tolerability of Ciprofloxacin|Adverse events (AE) Discontinuation of study drug due to probably study drug related AE|6 Months|Intention to Treat analysis.Adverse events (AE), which were classified as probably or possibly related to the study drug.||Adverse events|||Number
123734|NCT00609947|Primary|Major Adverse Cardiac Events (MACE) Rate|Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.|12 months post-procedure|"12-month MACE Rate was compared to a 20% performance goal.~1st 97 subjects enrolled and implanted with 2.25mm stents~1st 39 subjects enrolled and implanted with 2.5mm stents~1st 40 subjects enrolled and implanted with 2.75mm stents~A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"||Percentage||95% Confidence Interval|Number
123735|NCT00609947|Primary|In-segment Percent Diameter Stenosis at 8 Months Post-procedure|In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD – Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).|8 months post-procedure|The primary analysis sample consisted of 176 subjects (ITT) including the first 97 subjects with 2.25 mm, 39 subjects with 2.50 mm and 40 subjects with 2.75mm stents who met the study entry criteria, signed the written informed consent, and were enrolled in the trial.||percent diameter stenosis||95% Confidence Interval|Mean
123736|NCT00609869|Secondary|Median Time to Treatment Failure (TTF)|The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants||months||95% Confidence Interval|Median
123737|NCT00609869|Secondary|Clinical Benefit Rate|The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants||percentage of participants|||Number
123738|NCT00609869|Primary|Overall Response Rate (ORR)|The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.|Up to 6 years|All evaluable chronic lymphocytic leukemia participants||percentage of participants|||Number
123739|NCT00609804|Secondary|Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability|Defined as the number of participants with treatment-emergent grade 3/4 adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v3.0|18 months|All patients on study||participants|||Number
123740|NCT00609804|Secondary|Overall Response Rate|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients on study||participants|||Number
123741|NCT00609804|Primary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study||months||95% Confidence Interval|Median
123742|NCT00609765|Secondary|The Number of Participants With Radiographic Response|Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.|2 years||||||
123743|NCT00609765|Primary|Number of Participants With Progression Free Survival (PFS) at 12 Months|We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).|12 months|Per protocol at 12 months|||||
123744|NCT00609739|Secondary|Patients Who Relapsed|Number of patients whose disease relapsed.|1 Year|||participants|||Number
123745|NCT00609739|Secondary|Patients With Graft-Versus-Host-Disease|Number of patients who exhibited acute and/or chronic graft-versus-host disease.|Up to 30 Days Post Study Treatment|||participants|||Number
123746|NCT00609739|Secondary|Patients With Regimen-Related Toxicity|Number of patients with adverse events related to treatment.|Up to 30 Days Post Study Treatment|||participants|||Number
123747|NCT00609739|Primary|Disease-free Survival|Number of patients who were free of disease and alive at 1 year.|1 year|||Participants|||Number
123748|NCT00609674|Secondary|Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])|RQLQ(S) is a 28-item, self-administered, disease-specific (allergic rhinitis), quality of life instrument that assesses quality of life over a 1-week interval. Each question is scored from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment on quality of life. RQLQ(S): Possible score ranges from 0 to 6. Change from baseline is calculated as the score at the endpoint minus the score at baseline.|Baseline and Week 4|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123749|NCT00609674|Secondary|Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF|PNIF: Objective measure of nasal airway flow obstruction.|Daily; Baseline through End of Study (Week 4)|ITT Population||Liters/minute||Standard Error|Least Squares Mean
123780|NCT00609466|Secondary|Number of Participants Using Rescue Medication|Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.|Baseline up to 72 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF)||participants|||Number
125436|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after third treatment|Safety||cm||Full Range|Median
123750|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|||Points on a scale||Standard Error|Least Squares Mean
123751|NCT00609674|Secondary|Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.|The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123752|NCT00609674|Secondary|Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). AM, pre-dose iTOSS: sum of the 3 individual ocular symptom scores (scored on a scale of 0 [none] to 3 [severe], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||percent change||Standard Error|Least Squares Mean
123753|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS|The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123754|NCT00609674|Secondary|Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123755|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123756|NCT00609674|Secondary|Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123757|NCT00609674|Secondary|Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS|The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||percent change||Standard Error|Least Squares Mean
123758|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123759|NCT00609674|Secondary|Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS|TNSS = the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
124033|NCT00607789|Secondary|Weekly Episodes|The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)|12 weeks|The secondary efficacy analysis was a longitudinal analysis comparing the rate of change of binge weeks frequency during the treatment period between groups.||Days||Standard Deviation|Mean
123760|NCT00609674|Primary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)|TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS (performed in the morning [AM] and evening [PM]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|Intent-to-Treat (ITT) Population: all randomized subjects who received at least one dose of study drug||Points on a scale||Standard Error|Least Squares Mean
123761|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)|The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123762|NCT00609674|Secondary|Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)|The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12.|Daily; Baseline through End of Study (Week 4)|ITT Population||Points on a scale||Standard Error|Least Squares Mean
123763|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment – Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score|FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.|Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
123764|NCT00609622|Secondary|Change From Baseline in Functional Assessment of Cancer Treatment – Colorectal (FACT-C) Score|FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.|Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)|FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here “n” signifies those participants evaluated for this measure at specific time point for each cohort respectively.||Units on a scale||Standard Deviation|Mean
123765|NCT00609622|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|Data was not analyzed due to early study termination.|||||
123766|NCT00609622|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
123767|NCT00609622|Secondary|Two Year Survival Probability|Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)|Data was not analyzed due to early study termination.|||||
123768|NCT00609622|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)|Data was not analyzed due to early study termination.|||||
123797|NCT00608985|Secondary|Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 1&2|All treated patients||minutes||95% Confidence Interval|Median
123769|NCT00609622|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)|The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
123770|NCT00609622|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
123771|NCT00609518|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)||months||95% Confidence Interval|Median
123772|NCT00609518|Secondary|Overall Survival|Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact.|Randomization (≤4 weeks from baseline visit) to 12 months after randomization|Qualified Intent to Treat (Q-ITT)||months||95% Confidence Interval|Median
123773|NCT00609518|Secondary|Proportion of Participants With Best Overall Tumor Response (Response Rate)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response.|Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.|Qualified Intent to Treat (Q-ITT)||proportion of patients||95% Confidence Interval|Mean
123774|NCT00609518|Primary|Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity|"Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows:~Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. A detailed list of Serious and non-serious adverse events is provided in the Reported Adverse Event section."|From first dose of treatment to last dose of treatment plus 30 days|Qualified Intention to Treat (Q-ITT)||participants|||Number
123775|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain)."|Baseline to 72 hours after first intake of study drug|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
123776|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain)."|Baseline to 24 hours after first study drug intake|Intention to treat (ITT)and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
123777|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain)."|Baseline to 12 hours after first study drug intake|Intention to treat (ITT) and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
123778|NCT00609466|Secondary|Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain)."|Baseline to 6 hours after intake of first study drug|Intention to treat(ITT) and Last Observation Carried Forward (LOCF).||units||Standard Deviation|Mean
123779|NCT00609466|Secondary|Total Pain Relief (TOTPAR)|Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief.|Baseline to 48 hours after first study drug intake|Intention to treat(ITT)and Last Observation Carried Forward (LOCF)||units||Standard Deviation|Mean
123781|NCT00609466|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain)."|Baseline value to 48 hours after first study drug intake.|Intention to Treat - randomized subjects who were dosed and had a baseline pain intensity assessment. Last observation carried forward was used.||units||Standard Deviation|Mean
123782|NCT00609362|Secondary|Change in Gene Expression in Bone Marrow and Fat Cells||Before and after treatment||||||
123783|NCT00609362|Secondary|Difference in Percent Change in Level of C-terminal Telopeptide (CTx) Between the Rosiglitazone and Placebo Groups|C-terminal telopeptide is a marker of bone resorption. Its levels are measure in plasma using a chemiluminometric method (ECLIA).|At baseline and after 14 weeks of treatment|||Percent change from baseline||Standard Deviation|Mean
123784|NCT00609362|Secondary|Difference in Percent Change in Bone Marrow Fat (Given by a Lipid to Water Ratio) in the Spine.|Bone marrow fat was measured using MRI spectroscopy providing a measure of bone marrow fat as a ratio to bone marrow water, the lipid-water ratio (LWR)|Measured at baseline and after 14 weeks of treatment|||Percent change in LWR||Standard Deviation|Mean
123785|NCT00609362|Primary|Difference in Percent Change in Bone Mineral Density (BMD) From Baseline to 14 Weeks Between the Rosiglitazone Group and the Placebo Group|Difference in percent change in bone mineral density (BMD) from baseline to 14 weeks between the rosiglitazone group and the placebo group. BMD was assesed using dual x-ray absorptiometry (DXA)|BMD measured at baseline and after 14 weeks of treatment|||Percent change from baseline||Standard Deviation|Mean
123786|NCT00609167|Secondary|Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant|Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.|After 4 cycles of treatment|At the time of publication, data was available on 18 patients for group 2.||participants|||Number
123787|NCT00609167|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 12 cycles)|||participants|||Number
123788|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles|"Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment.~Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 12 cycles of treatment|No participants received 12 cycles of treatment; therefore, all participants are non-evalualble.||participants|||Number
123789|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment.~Criteria for CR, nCR, VGPR and PR are defined in prior outcomes."|After 8 cycles of treatment|Participants who received 8 cycles of treatment were analyzed.||participants|||Number
123790|NCT00609167|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.|Duration of study (up to 12 cycles)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.||months||95% Confidence Interval|Median
123791|NCT00609167|Secondary|Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles|"Response that was confirmed on 2 consecutive evaluations after 8 months of treatment.~CR, nCR and VGPR as defined in the primary outcome.~Partial Response(PR): >=50% reduction in serum M-component and/or~Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|4 cycles|Participants who received 4 cycles of treatment were analyzed.||participants|||Number
123792|NCT00609167|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause.|From date of registration until death (up to 5 years)|||months||95% Confidence Interval|Median
123793|NCT00609167|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~Bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|up to 5 years|||months||95% Confidence Interval|Median
123794|NCT00609167|Primary|Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment|"Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow."|After 4 months of treatment|||participants|||Number
123795|NCT00608985|Secondary|Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)|sLSO was the self-reported time to fall asleep as reported in the sleep diary|From baseline to Week 1&2|All treated patients with available data||minutes||95% Confidence Interval|Median
123796|NCT00608985|Secondary|Change From Baseline to Day 15&16 in LPS|LPS was defined as the time from the start of the PSG recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-wake (i.e., either sleep stage 1 (S1), sleep stage 2 (S2), slow-wave sleep (SWS), or rapid eye movement sleep(REM)) as determined by PSG|From baseline to Day 15&16|All treated patients||minutes||95% Confidence Interval|Median
123890|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
123798|NCT00608985|Primary|Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)|sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1&2|From baseline to Week 1&2|All treated patients with available data||minutes||95% Confidence Interval|Median
123799|NCT00608985|Primary|Change From Baseline to Day 15&16 in WASO|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.~For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 15&16|All treated patients||minutes||95% Confidence Interval|Median
123800|NCT00608985|Primary|Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)|"WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on.~For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1&2 and Day 15&16"|From baseline to Day 1&2|All treated patients||minutes||95% Confidence Interval|Median
123801|NCT00608959|Primary|Number of Subjects With Significantly Colonized Catheters, Defined as > or = to 15 Colony Forming Units- CFUs)|Roll plate cultures (quantitative) measured CFU on catheter tips after removal up to 7 days after insertion.|Each sampling point and the rate of catheter colonization for each treatment 72 hours to 7 days.|intravenous (IV) catheters were removed for culture from 5 subjects at 72 hours, 10 subjects at 5 days, and 10 subjects at 7 days.||participants|||Number
123802|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 7 Days|Change in the mean number of skin bacterial counts (log 10 CFU/cm2)which was calculated by subtracting log10 CFU/cm2 at 7 days (one sample per site per subject per timepoint) from log10CFU/cm2 at 0 hours in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 7 days post application.|In Part 2 of the study 25 subjects had only omiganan applied to sites across the upper chest or abdomen.Swab cultures were obtained over a period of 7 days at protocol-specified times||log 10 CFU/sq. cm||Standard Deviation|Mean
123803|NCT00608959|Primary|Change in Mean Number of Skin Bacterial Counts From Baseline to 72 Hours|Change in the mean number of skin bacterial counts (CFU/cm2) which was calculated by subtracting log10 CFU/cm2 at 72 hours (single sample per subject per timepoint) from the log10 CFU/cm2 at 0 hours (baseline) in Part 2.Baseline was calculated by 'pooling' samples from 6 sites adjacent to each timepoint.|Prior to first application (0 hours) to 72 hours post application|ITT set consists of all subjects who received at least one study treatment and had data available at 72 hours.||log 10 CFU/cm sq||Standard Deviation|Mean
123804|NCT00608907|Primary|Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours||Cycle 3 day 14 (72 hours post last dose)|Pharmacokinetic (PK) evaluable population, include all subjects completed 3 cycles of treatment and all PK assessments during the first 3 cycles of the study.||ng*h/mL||Standard Deviation|Mean
123805|NCT00608881|Secondary|Number Completing Study at Assigned Dosage Level||5 years|||participants completing study on drug|||Number
123806|NCT00608881|Secondary|Time to a Three-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years|||days to event||95% Confidence Interval|Median
123807|NCT00608881|Secondary|Time to a Two-Point Decline in TFC Score or Death|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years|||days to event||95% Confidence Interval|Median
123808|NCT00608881|Secondary|Change in Stroop Interference Test - Interference From Baseline to Month 60|Stroop Interference Test - interference score is the total number of correct items identified in 45 seconds and reflects an executive measure of inhibitory ability.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123809|NCT00608881|Secondary|Change in Stroop Interference Test - Word Reading From Baseline to Month 60|Stroop Interference Test - word reading score is the total number of correct words read in 45 seconds and reflects processing speed.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123810|NCT00608881|Secondary|Change in Stroop Interference Test - Color Naming From Baseline to Month 60|Stroop Interference Test - color naming score is the total number of correct colors identified in 45 seconds and reflects processing speed.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123811|NCT00608881|Secondary|Change in Verbal Fluency Test From Baseline to Month 60|The verbal fluency test is typically considered a measure of executive function. The score is the number of correct words produced across three 1-minute trials.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123812|NCT00608881|Secondary|Change in Symbol Digit Modalities Test (SDMT) From Baseline to Month 60|The SDMT assesses attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The score is the number of correctly paired abstract symbols and specific numbers in 90 seconds with higher scores indicating better cognitive functioning.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123813|NCT00608881|Secondary|Change in Behavioral Frequency x Severity Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. The total score is the sum of the product of the individual behavioral frequency and severity items (range 0-176) with higher scores representing more severe behavioral impairment.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123814|NCT00608881|Secondary|Change in Behavioral Frequency Score From Baseline to Month 60|The Unified Huntington's Disease Rating Scale (UHDRS) behavioral subscale assesses frequency and severity of psychiatric-related symptoms, including depressed mood, apathy, low self-esteem/guilt, suicidal thoughts, anxiety, irritable behavior, aggressive behavior, obsessional thinking, compulsive behavior, delusions, and hallucinations. A total score was calculated by summing up all the individual behavioral frequency items (range 0-56) with higher scores representing more severe behavioral impairment.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123815|NCT00608881|Secondary|Change in Total Motor Score From Baseline to Month 60|The motor section of the Unified Huntington's Disease Rating Scale (UHDRS) assesses motor features of Huntington disease with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor score is the sum of all the individual motor ratings, with higher scores (124) indicating more severe motor impairment than lower scores. The score ranges from 0 to 124.|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123816|NCT00608881|Secondary|Change in Independence Scale Score From Baseline to Month 60|The independence scale assesses independence on a 0 to 100 scale with higher scores indicating better functioning.|Baseline and Month 60|||units on a scale||Standard Error|Mean
123817|NCT00608881|Secondary|Change in Functional Checklist Score From Baseline to Month 60|"The functional assessment checklist includes 25 questions about common daily tasks. A score of 1 is given for each yes reply and a score of 0 is given for each no reply (scale range is 0-25). Higher scores indicate better functioning."|Baseline and Month 60|||units on a scale||Standard Error|Mean
123818|NCT00608881|Secondary|Change in Total Functional Capacity (TFC) Score From Baseline to Month 60|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|Baseline and Month 60|||units on a scale||Standard Error|Least Squares Mean
123819|NCT00608881|Primary|Joint Rank (Combination of Time to Death (for Subjects Who Died) and Change in Total Functional Capacity Score (TFC) From Baseline to Month 60 (for Subjects Who Survived))|The primary outcome variable at the start of the trial was the change in TFC score from baseline to Month 60. The Data and Safety Monitoring Board recommended to the trial leadership that they reconsider how they accommodate missing data from subjects who die in their primary analysis of the change in TFC score. Based on these recommendations, the trial leadership changed the primary analysis to that of a joint rank approach. TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best).|5 years|||rank||Standard Deviation|Mean
123820|NCT00608868|Secondary|Adverse Event|An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||participants|||Number
123821|NCT00608868|Secondary|Overall Survival||Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.||||||
123822|NCT00608868|Secondary|Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)|"Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0~4 scale (0=not at all to 4=very much). A possible score was 0~28.~The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L.~The percentage of patients who showed improvement is reported."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||percentage of participants|||Number
123823|NCT00608868|Secondary|Period of Progression-Free Survival|The median months without event of progression disease according to RECIST criteria is analysed.|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||months||95% Confidence Interval|Median
123824|NCT00608868|Primary|Objective Response Rate(ORR)|"Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated.~According RECIST criteria, CR(complete response) - the disappearance of all target lesions and ‘PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter."|Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)|||Percent of participants|||Number
123825|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Week 20|After the completion of all tests and procedures scheduled for week 20, participants with treated lipomas that remained palpable could have their treated lipomas excised.|Week 20|Safety population with biopsy results at week 20||participants|||Number
123826|NCT00608842|Primary|Number of Participants With Positive Histopathology Results at Screening|A needle core tissue sample biopsy was performed at screening for all treated lipomas.|Screening (prior to randomization)|Safety population with biopsy results at screening||participants|||Number
123827|NCT00608842|Primary|Number of Participants With Clinically Significant Changes in Vital Signs or Weight||Up to 24 weeks|Safety population||participants|||Number
123828|NCT00608842|Secondary|Percent Change From Baseline in the Sum of the Areas of All Treated Lipomas|Percent change from baseline was calculated as the baseline total lipoma area - postbaseline total lipoma area / baseline total lipoma area * 100. A positive change indicates a reduction in size.|Baseline and week 12 (last treatment session), week 16 (4 weeks after last treatment), and week 20 (8 weeks after last treatment)|MITT Population||percent change||Standard Deviation|Mean
123829|NCT00608842|Primary|Number of Participants With Newly Occurring or Worsening Biochemistry/Hematology/Urinalysis Abnormalities|An abnormality is defined as a value outside the limits of the expanded normal range/notable range.|24 weeks|Safety population||participants|||Number
123830|NCT00608842|Secondary|Percentage of Participants With Complete Clearance or ≥ 75% Clearance|"At randomization 1 to 3 lipomas were selected for treatment. Lipomas were measured in 3 dimensions (longest length, perpendicular width, and height if possible) using digital calipers.~Complete clearance indicates target lipoma(s) not present or detectable, and ≥ 75% clearance is defined as a ≥ 75% reduction from baseline in the area of target lipoma(s).~For participants with > 1 target lipoma, the total area of all target lipomas was used in the calculation of response."|Baseline and week 20 (8 weeks after last dose)|MITT Population||percentage of participants|||Number
123891|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
123831|NCT00608842|Primary|Number of Participants With Adverse Events (AEs)|"Severity of AEs was determined using the following scale:~Mild: The participant was aware of a sign or symptom, but it was easily tolerated; Moderate: Discomfort or interference with usual activity; Severe: Incapacitating, with inability to engage in usual activity. The investigator determined the relationship of each AE to the administration of study material by answering the question: “Was there a reasonable possibility that the event may have been caused by treatment with study material?” A serious AE was an event that constituted a significant medical hazard or side effect, regardless of the investigator’s or sponsor’s opinion regarding relatedness to study material. Serious AEs included any event that was fatal or life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other significant medical hazard."|Up to 24 weeks|Safety population (all participants who received at least 1 dose of study medication)||participants|||Number
123832|NCT00608829|Primary|Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment|Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).|one year|||Participants|||Number
123833|NCT00608777|Primary|The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2||week 2||||||
123834|NCT00608634|Secondary|Skin Related Events From Perillyl Alcohol at Administered Doses by Participants|The events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI)|3 months|||participants|||Number
123835|NCT00608634|Primary|Change in Histopathology Score of Sun Damaged Skin by Treatment Group|The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 & 2), 2- inflammation (grades 0, 1 & 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were >3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of >3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective.|Baseline to 3 months|change in histopathological scoring was calculated only for participants with baseline and end of study measurements. (n=79)||units on a scale||Standard Deviation|Mean
123836|NCT00608582|Primary|Phrase Length|Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who received either Real rTMS or Sham rTMS||number of words per phrase length||Standard Deviation|Mean
123837|NCT00608582|Primary|Picture Naming|Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures|Baseline and 2 months after the last rTMS treatment session|Chronic Stroke Patients with Aphasia who receive either a Real rTMS series or a Sham rTMS series||number of pictures||Standard Deviation|Mean
123838|NCT00608569|Secondary|Adherence to Second Line HAART Regimen|Number of participants with self-reported 100% adherence over the week prior to study visit|At weeks 4, 8, 12, 24, 36, 48 and 52|Only the 257 eligible participants were included in the analysis. Self-reported adherence was collected face-to-face or by self-report on the Adherence/Quality of Life/Psychosocial Interview form. Only adherence to LPV/rtv was collected.||participants|||Number
123839|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab or Sign/Symptom Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.||weeks||95% Confidence Interval|Number
123840|NCT00608569|Secondary|Time to First Grade 3 or 4 Sign or Symptom|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.||weeks||95% Confidence Interval|Number
123841|NCT00608569|Secondary|Time to First Grade 3 or 4 Lab Event|5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event|52 weeks since randomization|Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed.||weeks||95% Confidence Interval|Number
123842|NCT00608569|Secondary|CD8 Count at Follow-up Visits|CD8 cell count (median, inter-quartile range)|At week 4, 12, 24, 36, and 48|||cells/mm3||Inter-Quartile Range|Median
123843|NCT00608569|Secondary|CD4 Count at Follow-up Visits|CD4 cell count (median, inter-quartile range)|At Weeks 4, 12, 24, 36, and 48|||cells/mm3||Inter-Quartile Range|Median
123844|NCT00608569|Secondary|Confirmed Virologic Failure at or Prior to Week 24|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported.|At or prior to Week 24|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.||participants|||Number
123845|NCT00608569|Primary|Confirmed Virologic Failure at or Prior to Week 48|Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported.|At or prior to Week 48|Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed.||participants|||Number
123892|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123846|NCT00608543|Primary|Spatial Working Memory (SWM) Strategy Score|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention||units on a scale||Standard Deviation|Mean
123847|NCT00608543|Primary|Spatial Working Memory (SWM) Between Errors for 6-move Problems|The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers because data were collected pre- and post-treatment||number of errors||Standard Deviation|Mean
123848|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention||milliseconds||Standard Deviation|Mean
123849|NCT00608543|Secondary|Change in Hamilton Rating Scale for Depression (HRSD - 17-item)|The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.|6 weeks|Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention||units on a scale||Standard Deviation|Mean
123850|NCT00608543|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire|The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.|6 weeks|Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention||units on a scale||Standard Deviation|Mean
123851|NCT00608543|Primary|Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems|The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.|baseline and 6 weeks|Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention||milliseconds||Standard Deviation|Mean
123852|NCT00608530|Secondary|Percentage of Participants With at Least 25% Improvement on Global Impression of Change|"Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as Improved, No change, or Worse. Participants rating themselves as Improved were asked to estimate percentage of improvement (i.e., 1 to 100%). Percentage of participants with at least 25% improvement were compared between treatment groups."|End of Treatment (8 weeks)|Based on per-protocol population, consisting of all participants who received at least one dose of the intervention and for whom baseline and week 8 data were available.||Percentage with at least 25% improvement|||Number
123853|NCT00608530|Secondary|Numeric Pain Rating Scale (Numerical Rating Scale, 0-10)|"The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from 0 to 1 0 where 0 indicates no pain and 10 indicates the worst imaginable pain."|Baseline, End of Treatment (8weeks)|Based on per protocol population. All participants with baseline and week 8 scores.||units on a scale||Standard Deviation|Mean
123854|NCT00608530|Primary|Roland and Morris Disability Questionnaire|"The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase because of my back pain (e.g., Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability."|Baseline, End of Treatment (8 weeks)|Per protocol population. All participants with baseline and Week 8 disability scores.||units on a scale||Standard Deviation|Mean
123855|NCT00608517|Secondary|Number of Participants With Chronic Graft Versus Host Disease (GVHD)|As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement|100 days|||participants|||Number
123856|NCT00608517|Secondary|Overall Survival|Overall survival at 1 year|1 year|||participants|||Number
123857|NCT00608517|Secondary|Number of Subjects With All-cause Mortality|Death from any cause at 100 days|at 100 days|||participants|||Number
123858|NCT00608517|Secondary|Number of Participants Who Relapsed at 1 Year||1 year|||participants|||Number
123859|NCT00608517|Secondary|Number of Participants With Acute Graft-versus-host Disease (GVHD)|Participants who exhibit acute GVHD.|100 days|||participants|||Number
123860|NCT00608517|Secondary|Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells|Recovery of the neutrophil portion of white blood cells and showing complete donor cells.|42 days|Patients who received treatment and who did not die before day 42.||participants|||Number
123893|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
123861|NCT00608517|Primary|Number of Participants With 100-day Non-relapse Mortality|Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF).|100 days|||participants|||Number
123862|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
123863|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
123864|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123865|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
123866|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123867|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123868|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL/hr||Standard Deviation|Mean
123869|NCT00608491|Secondary|Change in Blood N Terminal Pro - B Natriuretic Peptides||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123870|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
123871|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
123872|NCT00608491|Secondary|Best Available Glomerular Filtration Rate Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
123873|NCT00608491|Secondary|Best Available Serum Creatinine Change|Core laboratory when available. If not available, local laboratory results were used.|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
123874|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
123875|NCT00608491|Secondary|Weight Change||Baseline to Day 60|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123876|NCT00608491|Secondary|Glomerular Filtration Rate Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
123877|NCT00608491|Secondary|Creatinine Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
123878|NCT00608491|Secondary|Change in Furosemide-Equivalent Dose|Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)|Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg||Standard Deviation|Mean
123879|NCT00608491|Secondary|Weight Change||Baseline to Day 30|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123880|NCT00608491|Secondary|Change in Blood High Sensitivity C-Reactive Protein||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
123881|NCT00608491|Secondary|Change in Blood Carboxy-terminal Telopeptide of Collagen Type I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
123882|NCT00608491|Secondary|Change in Blood Endothelin-1||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123883|NCT00608491|Secondary|Change in Blood Procollagen III N-terminal Propepide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ug/L||Standard Deviation|Mean
123884|NCT00608491|Secondary|Change in Blood Aldosterone||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123885|NCT00608491|Secondary|Change in Blood High Sensitivity Troponin I||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123886|NCT00608491|Secondary|Change in Plasma Renin Activity||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||ng/mL/hr||Standard Deviation|Mean
123887|NCT00608491|Secondary|Change in Blood N Terminal Pro-Natriuretic Peptide||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||pg/mL||Standard Deviation|Mean
123888|NCT00608491|Secondary|Change in Blood Uric Acid||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
123889|NCT00608491|Secondary|Change in Blood Cystatin C||Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/L||Standard Deviation|Mean
123911|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”."|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
123912|NCT00608491|Secondary|Change in Dyspnea Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better"|Baseline to Day 7/Discharge|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
123913|NCT00608491|Secondary|Change in Global Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”."|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
123914|NCT00608491|Secondary|Dyspnea Visual Analog Scale|"Scale range: -100 , +100~-100=worse, +100=better"|Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||units on a scale||Standard Deviation|Mean
123915|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
123916|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
123917|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
123918|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
123919|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
123920|NCT00608491|Primary|Change in Weight||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123921|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
123922|NCT00608491|Secondary|Cumulative Net Fluid Loss||Randomization through Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL||Standard Deviation|Mean
123923|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 6|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123924|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 5|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123925|NCT00608491|Secondary|Change in Weight||Change from Baseline to Day 3|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123926|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 2|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123927|NCT00608491|Secondary|Changes in Weight||Change from Baseline to Day 1|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||lbs||Standard Deviation|Mean
123928|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
123929|NCT00608491|Secondary|Change in Serum Creatinine||Change from Baseline to Day 7|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
123930|NCT00608491|Secondary|Change in Glomerular Filtration Rate||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mL/min||Standard Deviation|Mean
123931|NCT00608491|Primary|Change in Serum Creatinine||Change from Baseline to Day 4|Participants analyzed consisted of those participants who had the endpoint data available to be derived.||mg/dL||Standard Deviation|Mean
123932|NCT00608426|Secondary|7-day Point Prevalence Abstinence||12 months after randomizatoin|Out of the 3382 completed follow-up surveys, 3056 completed the 7-day point prevalence outcome.||percentage of participants|||Number
123933|NCT00608426|Secondary|Treatment Utilization Rates for Counseling and/or Pharmacotherapy||12 months after randomization|||percentage of participants|||Number
123934|NCT00608426|Primary|Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence||12 months after randomization|Out of the 3382 completed follow-up surveys, 3307 completed the primary smoking-abstinence outcome.||percentage of participants|||Number
123935|NCT00608322|Secondary|Lactate Clearance (Blood)||0-2 hours of study drug administration||||||
123936|NCT00608322|Primary|Change in Sublingual Microcirculatory Flow Index (MFI)|The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.|0-2 hours of study drug administration|||units on a scale||Inter-Quartile Range|Median
123937|NCT00608322|Primary|Change in the Sequential Organ Failure Assessment (SOFA) Score||0-24 hours from protocol initiation||||||
123938|NCT00608244|Primary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.||participants|||Number
123939|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24) on Day 21.|"Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).~The following time points were used to obtain the PK curve for LCP-Tacro on day 21: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20 and 24 hours post-dose."|21 Days|"57 completed the study but one patient was excluded from the PP analysis due to low trough levels.~The arithmetic mean and standard deviation is given."||ng*hr/mL||Standard Deviation|Mean
123941|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|"Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.~The following time points were used to obtain the PK curve for Prograf on day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 15, 16, 20 and 24 hours after the morning dose."|7 Days|The arithmetic mean and standard deviation is given.||ng*hr/mL||Standard Deviation|Mean
123942|NCT00608244|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 Days|The arithmetic mean and standard deviation is given.||ng/mL||Standard Deviation|Mean
123943|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123944|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123945|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123946|NCT00608205|Secondary|Solid Foods|"Quality of life questionnaire asking I can eat solid foods.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123947|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123948|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123949|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123950|NCT00608205|Secondary|Alcohol Consumption|"Quality of life questionnaire asking I drink alcohol (e.g. beer, wine).~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123951|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123952|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123953|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123954|NCT00608205|Secondary|Swallowing|"Quality of life questionnaire asking I can swallow naturally and easily.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123955|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123956|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123957|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123958|NCT00608205|Secondary|Eating|"Quality of life questionnaire asking I am able to eat the foods i like.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123959|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123960|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123961|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123962|NCT00608205|Secondary|Quality of Life|"Quality of life questionnaire asking I am content with the quality of my life right now.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123963|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123964|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123965|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123966|NCT00608205|Secondary|Pain|"Quality of life questionnaire asking I have pain in my mouth, throat or neck.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123967|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123968|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123969|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123970|NCT00608205|Secondary|Dry Mouth|"Quality of life questionnaire asking My mouth is dry.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123971|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea."|24 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123972|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|12 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123973|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement."|8 months from start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123974|NCT00608205|Secondary|Nausea Level|"Quality of life questionnaire asking I have nausea.~The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).~N (number of patients analyzed) is based on number of patients who completed the question."|12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||units on a scale||Standard Deviation|Mean
123975|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||24 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
123976|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
123977|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||8 months after start of treatment|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
123978|NCT00608205|Secondary|Number of Patients That Required a Feeding Tube||12 weeks (after treatment)|Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.||participants|||Number
123979|NCT00608205|Secondary|Disease Recurrence|Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.|2 years after start of study|Patients that had a complete response after 12 weeks of therapy||participants|||Number
123980|NCT00608205|Secondary|Number of Patients With a Pathological(Final)Complete Response|A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.|at 12 weeks after completing chemoradiotherapy and surgery|||participants|||Number
123981|NCT00608205|Secondary|Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor|Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.|at 12 weeks after completing chemoradiotherapy|intention to treat (ITT)||participants|||Number
123982|NCT00608205|Secondary|Overall Survival|Number of patients still alive from 2 years from start of study|2 yrs from start of study|intention to treat (ITT)||participants|||Number
123983|NCT00608205|Secondary|Patterns of Failure|Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.|2 years from start of study|intention to treat (ITT)||participants|||Number
123984|NCT00608205|Primary|Relapse Free Survival|Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..|at 2 yrs from start of study|intention to treat (ITT)||participants|||Number
123985|NCT00608140|Secondary|Perioperative Mortality||Measured between Days 0 and 30 postsurgery|||participants|||Number
123986|NCT00608140|Secondary|Total Mortality (All Causes)||Measured at Month 18||||||
123987|NCT00608140|Secondary|Total Days Alive and Total Days Not Hospitalized||Measured at baseline and Month 18||||||
123988|NCT00608140|Secondary|Change in Minnesota Living With Heart Failure (MLHF) Score||Measured at baseline and Month 18||||||
123989|NCT00608140|Secondary|Change in 6-minute Walk Test||Measured at baseline and Month 18||||||
123990|NCT00608140|Secondary|Peak VO2||Measured at Month 18||||||
123991|NCT00608140|Primary|Effect of Adding SMVR to OMT Alone on LV Remodeling, Specifically LV End-systolic Volume Index (LVESVI)||Measured at Month 18|Data were not analyzed due to study termination|||||
123992|NCT00608023|Primary|Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52|Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.|Baseline and Week 52|||mg/dL||Standard Deviation|Mean
123993|NCT00608023|Primary|Changes From Baseline in Fasting Blood Glucose at Week 52|Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.|Baseline and Week 52|||mg/dL||Standard Deviation|Mean
123994|NCT00608023|Other Pre-specified|Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52|Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.|Baseline and Week 52|||ratio||Standard Deviation|Mean
123995|NCT00608023|Other Pre-specified|Changes From Baseline in Triglycerides at Week 52|Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.|Baseline and Week 52|||mg/dL||Standard Deviation|Mean
124063|NCT00607672|Primary|Tissue-type Plasminogen Activator (t-PA) Antigen Response|To compare the effects of angiotensin II type I (AT1) receptor antagonism or angiotensin-converting enzyme (ACE) inhibition versus placebo on the fibrinolytic responses to cardiopulmonary bypass (CPB) as measured by t-PA antigen response|From the start of surgery until postoperative day 2|||ng/mL||Standard Error|Mean
123996|NCT00608023|Secondary|Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52|Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.|Baseline and Week 52|All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug).||cm^2||Standard Deviation|Mean
123997|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
123998|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
123999|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124000|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124001|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124002|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124003|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124004|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124005|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units||Standard Deviation|Mean
124006|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint|The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 32 weeks|All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124007|NCT00607919|Secondary|Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint|The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124008|NCT00607919|Secondary|Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint|The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124009|NCT00607919|Secondary|Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint|LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124010|NCT00607919|Secondary|Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124011|NCT00607919|Secondary|Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint|The TOWRE is a measure of an individual’s ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124012|NCT00607919|Secondary|Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32–Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124013|NCT00607919|Secondary|Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124014|NCT00607919|Secondary|Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint|The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124034|NCT00607789|Primary|Binge Eating Days|The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7).|12 weeks|The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups.||Mean Number of days||Standard Deviation|Mean
125649|NCT00593606|Primary|Change in Gamma-Glutamyltransferase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
124015|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint|The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124016|NCT00607919|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
124017|NCT00607919|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 weeks|All randomized participants with a baseline and at least one post-baseline result.||units on a scale||Standard Error|Least Squares Mean
124018|NCT00607880|Secondary|Termination of Use of the Indwelling Port at 12 Months After Port Insertion|The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.|Up to 12 months after port insertion|||participants|||Number
124019|NCT00607880|Secondary|Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion|We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.|Up to 12 months after port insertion|All patients accrued to this study that had their port removed within12 months for any reason other than infection/occlusion were included in this analysis. 28 patients using the Standard Access Port and 30 patients using the Vortex Implantable Access Port had port removal prior to 12 months due to reasons other than infection or occlusion..||participants|||Number
124020|NCT00607880|Secondary|Death From All Causes|Number of patients that died during treatment due to any cause.|Up to 12 months after port insertion|||participants|||Number
124021|NCT00607880|Primary|Port Failure Within 12 Months of Port Insertion|We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.|Up to 12 months from port insertion|Patients with port failure within 12 months and patients that were followed 12 months without port failure were included in this analysis.||percentage of patients||95% Confidence Interval|Number
124022|NCT00607867|Secondary|Change in Fasting Triglycerides at 5 Weeks From Baseline|Overnight fasting triglycerides concentration was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention|||mg/dl||Standard Error|Mean
124023|NCT00607867|Primary|Change in Overnight Fasting Glucose Concentration at 5 Weeks From Baseline|Overnight fasting glucose concentration was measured before dietary intervention and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention|||mg/dl||Standard Error|Mean
124024|NCT00607867|Primary|Change in Body Weight at 5 Weeks From Baseline|Subjects were to remain weight stable. We expected less than 2 pound weight change over 5 weeks. Weight was measured before dietary intervention, and after 5 weeks of dietary intervention.|baseline and 5 weeks after dietary intervention|||pounds||Standard Error|Mean
124025|NCT00607867|Primary|Change in Total Glucose Area at 5 Weeks From Baseline|The area response is measured using zero as baseline. The area is measured before dietary intervention, and following 5 weeks of dietary intervention.|Baseline and 5 weeks after dietary intervention|||mg hr/dl||Standard Error|Mean
124026|NCT00607867|Secondary|Microalbumin Excretion|change in urinary albumin excretion was measured before dietary intervention and after 5 weeks of dietary intervention|baseline and 5 weeks after dietary intervention|||mg/day||Standard Error|Mean
124027|NCT00607867|Primary|Change in %Hemoglobin A1c at 5 Weeks From Baseline|Hemoglobin A1c measured before and after 5 weeks on the diet|Baseline and 5 weeks after dietary intervention|||Change in % A1c at 5 weeks from baseli||Standard Error|Mean
124028|NCT00607815|Secondary|State-Trait Anxiety Scale|Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73.|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
124029|NCT00607815|Secondary|State-Trait Anger Scale (STAXI)|Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
124030|NCT00607815|Secondary|Beck Depression Inventory - II (BDI-II)|Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed.|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
124031|NCT00607815|Primary|PTSD Checklist (PCL)|17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed|post-treatment, at 3 months and 1 year|||units on a scale||Standard Deviation|Mean
124032|NCT00607815|Primary|Clinician Administered PTSD Scale|Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed.|Post-treatment, at 3 months and 1 year|Generalized estimating equations (GEE) were used to test study hypotheses.||units on a scale||Standard Deviation|Mean
124035|NCT00607724|Secondary|PFS: Participants With BCC|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis. Number of participants censored for Stage 1+Stage 2 150 mg, and Stage 1+Stage 2 270 mg were 8 and 7 subjects, respectively, and no subject censored from Stage 1 540 mg group.||months||95% Confidence Interval|Median
124036|NCT00607724|Secondary|Progression-Free Survival (PFS): All Participants|PFS was defined as the time from first dose of GDC-0449 to documented disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using RECIST v1.0) or death from any cause within 30 days of the last dose of GDC-0449, whichever occurred first.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population. Number of participants censored for Stage 1 150 mg, 270 mg, and 540 mg were 1, 2, and 1 subjects, respectively and for Stage 2 BCC 150 mg, 270 mg, Stage 2 Safety Expansion Cohort 150 mg, and Stage 2 New Formulation 150 mg were 2, 6, 1, and 6 subjects, respectively.||months||95% Confidence Interval|Median
124037|NCT00607724|Secondary|Duration of Objective Response: Participants With BCC|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable participants; only participants with BCC who achieved a best overall response of CR or PR were included in the analysis.||months||Full Range|Median
124038|NCT00607724|Secondary|Duration of Objective Response: All Participants|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants who achieved a best overall response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
124039|NCT00607724|Secondary|Percentage of Participants With a BOR of CR or PR: Participants With Basal Cell Carcinoma|BOR was defined as the best objective response observed during the treatment period according to RECIST v1.0. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population; only participants with BCC were included in the analysis.||percentage of participants|||Number
124040|NCT00607724|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR): All Participants|BOR was defined as the best objective response (complete or partial response determined by two consecutive investigator assessments which were at least 28 days apart) observed during the treatment period according to RECIST v1.0. CR: disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters.|Screening, at Week 8 thereafter every 8 weeks, up to Week 116|Efficacy-evaluable population were those with measurable disease at baseline and who received at least 1 dose of GDC-0449 and either had a post-baseline tumor assessment or progressed before any tumor assessment.||percentage of participants|||Number
124041|NCT00607724|Secondary|Percentage of Participants With a Greater Than (>) 2-Fold Down-Modulation of GLI1 Expression in Skin Biopsy-Derived or Hair Follicle-Derived Messenger Ribonucleic Acid (mRNA)|Ribonucleic acid (RNA) was extracted from biopsy specimens of noninvolved skin or hair follicles at baseline and at 7 and 21 days after the start of daily drug therapy. Control mRNA was obtained from formalin-fixed, paraffin-embedded samples of normal skin and hair follicles from participants who were not enrolled in the study.|Baseline up to Day 29|"Pharmacodynamic-evaluable population included participants who had hair and/or skin samples available from Day 1 and at least one post-baseline sample while on study treatment. Here number of participants analyzed = participants evaluable for this measure and n= participants evaluable for the specific category."||percentage of participants|||Number
124042|NCT00607724|Primary|Accumulation Index (AI) After Multiple Doses of GDC-0449|AI was calculated using the formula [AI = AUC(0-24) on Day 15/AUC(0-24) on Day 1]. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AI was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AI was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AI.|||||
124043|NCT00607724|Primary|AUC0-24 After Multiple Doses of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|AUC0-24 was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of AUC0-24.|||||
124062|NCT00607672|Primary|Plasminogen Activator Inhibitor-1 (PAI-1) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the fibrinolytic responses to CPB as measured by PAI-1 response|From the start of surgery until postoperative day 2|||ng/mL||Standard Error|Mean
124044|NCT00607724|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) After a Single Dose of GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|PK-evaluable population.||mcM*day||Standard Deviation|Mean
124045|NCT00607724|Primary|Average Plasma Concentration at Steady State (Css, Avg) After Multiple Doses of GDC-0449|Steady state GDC−0449 plasma concentrations (Css) were calculated as an average of plasma concentrations from Study Day 21 (Stage 2) or Study Day 28 (Stage 1) onward.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|"PK-evaluable population. Here number of participants analyzed = participants evaluable for this measure."||mcM||Standard Deviation|Mean
124046|NCT00607724|Primary|Tmax After Multiple Doses of GDC-0449|Tmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax, and as Tmax was related to Cmax, it was also not estimated.|||||
124047|NCT00607724|Primary|Time to Maximum Plasma Concentration (Tmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and PD data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|PK-evaluable population.||days||Full Range|Median
124048|NCT00607724|Primary|Cmax After Multiple Doses of GDC-0449|Cmax was estimated if there were extensive PK sampling in more that 50% of the participants to form a curve.|-5 minutes (pre-dose), 0.5,1,2,4,8 hours post-dose on Day [D] 1; 2,3,4; -5 minutes (pre-dose) on D8,15,22,29,36,64,92,120,148,176,204,232,260,288,316,344;every 4 weeks after D345; end of treatment and study (up to 28 days after last dose), up to 2 years|Cmax was not reported as there were <50% participants with extensive PK sampling and the PK profiles were flat over 24 hours at steady state which did not allow estimation of Cmax.|||||
124049|NCT00607724|Primary|Maximum Observed Plasma Concentration (Cmax) After a Single Dose of GDC-0449|Phase I comprised of two stages, a dose-escalation stage with the goal of estimating the maximum tolerated dose (Stage 1), and an expanded cohort to collect additional safety, PK, and pharmacodynamic (PD) data at the proposed Phase II dose (Stage 2). Phase II represented the additional cohort initiated with 150 mg hard gelatin capsule identified from the safety, PK and PD data from Stage 1 of the trial.|-5 minutes (pre-dose) and 0.5, 1, 2, 4, 8, 24 hours post-dose on Day 1; additionally for stage 1 arms: 48 hours (Day 3), 72 hours (Day 4) post-dose and – 5 minutes (pre-dose) on Day 8|Pharmacokinetic (PK)-evaluable population included participants who had at least Day 1 PK samples available.||micromolar (mcM)||Standard Deviation|Mean
124050|NCT00607724|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs)|A DLT was defined as any Grade 3 or 4 hematologic or major organ toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) that occurred during the first 35 days after the initiation of study drug (Days 1−35) and was attributable to GDC-0449.|Up to Week 6|Safety-evaluable population.||percentage of participants|||Number
124051|NCT00607672|Primary|Interleukin-10 (IL-10) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by the IL-10 response|From the start of surgery until postoperative day 2|||pg/mL||Standard Error|Mean
124052|NCT00607672|Primary|Interleukin-8 (IL-8) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-8|From the start of surgery until postoperative day 2|||pg/mL||Standard Error|Mean
124053|NCT00607672|Primary|Interleukin-6 (IL-6) Response|To compare the effects of AT1 receptor antagonism or ACE inhibition versus placebo on the inflammatory response to CPB as measured by IL-6|From the start of surgery until postoperative day 2|||pg/mL||Standard Error|Mean
124054|NCT00607672|Secondary|Length of Hospital Stay||From the start of surgery until discharge from hospital|||days||Standard Error|Mean
124055|NCT00607672|Secondary|Stroke|New onset neurological deficit with a duration of longer than 24 hours|From arrival in intensive care unit until discharge from hospital|||percentage of patients|||Number
124056|NCT00607672|Secondary|Acute Kidney Injury|Acute kidney injury (AKI) was defined according to Acute Kidney Injury Network (AKIN) criteria,specifically any increase in subject serum creatinine concentration of 50% or 0.3 mg/dL (26.5 umol/L) within 72 hours of surgery.|From the start of surgery until postoperative day 3|||percentage of patients|||Number
124057|NCT00607672|Secondary|New Onset Atrial Fibrillation|New onset atrial fibrillation based on electrocardiogram (ECG) rhythm strips with a duration longer than 10 seconds|From arrival in intensive care unit until discharge from hospital|||percentage of patients|||Number
124058|NCT00607672|Secondary|Vasopressor Drug Use||From the end of cardiopulmonary bypass until arrival in intensive care unit|||percentage of patients|||Number
124059|NCT00607672|Secondary|Blood Product Transfusion Requirement|Percentage of patients that received blood product transfusion|From the start of surgery until discharge from hospital|||percentage of patients|||Number
124060|NCT00607672|Secondary|Re-exploration for Bleeding|The percentage of patients that were taken back to the operating room for re-exploration because of bleeding|From arrival in intensive care unit until discharge from hospital|||percentage of patients|||Number
124061|NCT00607672|Secondary|Blood Loss|Blood loss over 24 hours as measured by chest tube output|First 24 hours after arrival in the intensive care unit|||mL||Standard Error|Mean
124064|NCT00607594|Secondary|Association Between Correlative Markers and Clinical Outcomes|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|At baseline, 6 months, and then at 1 year||||||
124065|NCT00607594|Secondary|Tolerability|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Weekly during treatment||||||
124066|NCT00607594|Secondary|Safety|Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.|Weekly during treatment||||||
124067|NCT00607594|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year (median, 6 months, and 1 year)||||||
124068|NCT00607594|Secondary|Median Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year|||months||95% Confidence Interval|Median
124069|NCT00607594|Secondary|Progression-free Survival|Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Measured from the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy||||||
124070|NCT00607594|Secondary|Time to Progression|The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.|Up to 1 year (median, 6 month, 1-year)|||months||95% Confidence Interval|Median
124071|NCT00607594|Primary|Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)||Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter|||participants|||Number
124072|NCT00607594|Primary|Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)|PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.|Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter|||participants|||Number
124073|NCT00607477|Primary|Magnitude of Change in Blood Pressure||21 days|No participants analyzed due to poor accrual and insufficient numbers of participants.|||||
124074|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steadystate.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||milliliter per kilogram||Standard Deviation|Mean
124075|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||milliliter/minute/kilogram||Standard Deviation|Mean
124076|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Mean Residence Time From Time 0 to Infinity (MRTinf)|MRTinf is an average duration of the drug in the body from time zero to infinity, and is expressed in minutes.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||minutes||Standard Deviation|Mean
124077|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Elimination Half-Life (t1/2)|t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in minutes and derived from the terminal slope of the concentration versus time curve.|Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||minutes||Standard Deviation|Mean
124078|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUCinf)||Weeks 1 and 27|"PK population with evaluable participants for this endpoint. In the categories listed below, N signifies the number of participants evaluable for the timepoint."||minute*nanogram per milliliter||Standard Deviation|Mean
124079|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Area Under the Serum Concentration-Time Curve From Time 0 to the Final Time Point With a Concentration of at Least Lower Limit of Quantitation (AUClast)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.||minute*nanogram per milliliter||Standard Deviation|Mean
124080|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Time of Maximum Observed Serum Concentration (Tmax)||Weeks 1 and 27|PK population. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.||minutes||Standard Deviation|Mean
124081|NCT00607386|Secondary|Single- and Repeat-Dose Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)||Weeks 1 and 27|Pharmacokinetic (PK) population was defined as all enrolled participants who had at least one serum concentration measurement available. In the categories listed below, “N” signifies the number of participants evaluable for the timepoint.||nanogram per milliliter||Standard Deviation|Mean
124094|NCT00607373|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Inter-Quartile Range|Median
124082|NCT00607386|Secondary|Mean Change From Baseline to Week 53 in Normalized Urinary Glycosaminoglycan (GAG) Levels|Analysis of urinary GAG levels was performed at baseline, Week 18, Week 36, and Week 53 as an assessment of the pharmacodynamic effects of Elaprase (idursulfase).|Baseline, Weeks 18, 36 and 53|Safety population. In the categories listed below, 'N' signifies the number of participants evaluable for the timepoint.||microgram/milligram creatinine||Standard Deviation|Mean
124083|NCT00607386|Primary|Safety Evaluation|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs occurred after start of study treatment until 30 days after the last infusion of idursulfase, were reported.|From the start of study treatment until 30 days after the last infusion of idursulfase, up to 53 weeks|Safety population was defined as all enrolled participants who received at least one study dose (or any portion of a dose) of idursulfase.||participants|||Number
124084|NCT00607373|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Inter-Quartile Range|Median
124085|NCT00607373|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
124086|NCT00607373|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
124087|NCT00607373|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
124088|NCT00607373|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||ratio||Standard Deviation|Mean
124089|NCT00607373|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
124090|NCT00607373|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Inter-Quartile Range|Median
124091|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
124092|NCT00607373|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
124093|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
124095|NCT00607373|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Inter-Quartile Range|Median
124096|NCT00607373|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
124097|NCT00607373|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
124098|NCT00607373|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
124099|NCT00607373|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||mg/dL||Standard Deviation|Mean
124100|NCT00607373|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
124101|NCT00607373|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28 )|Full analysis set||mg/dL||Standard Deviation|Mean
124102|NCT00607373|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set||percentage of baseline||Standard Deviation|Mean
124103|NCT00607373|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. If the Study Day 1 and screening LDL-C values were >12% different (relative to the maximum value), then the screening value was not used, because the Study Day 1 value represents the best estimate of the patient's condition at the beginning of study drug administration. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.||percentage of baseline||Standard Deviation|Mean
124104|NCT00607321|Secondary|Number of Participant With Target Vessel Failure at 12 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|12 month|Includes all subjects receiving bifurcation stents and having evaluable data.||participants|||Number
124105|NCT00607321|Secondary|Number of Participants With Target Vessel Failure at 9 Months.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|9 month|Includes all subjects receiving bifurcation stents and having evaluable data||participants|||Number
124106|NCT00607321|Secondary|Number of Participants With Target Vessel Failure (TVF) at 6 Months|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|6 month|Includes all patients receiving bifurcation stent and having evaluable data.||participants|||Number
124107|NCT00607321|Secondary|Device Success|Device success is reported as Historical-standard definition: attainment of <50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.|During index procedure|ITT included all subjects after a run-in subject at each site.||participants|||Number
124108|NCT00607321|Primary|Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.|TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.|30 days|||Participants|||Number
124109|NCT00607269|Secondary|Self-reported Sexual Behaviors at 12-month Follow-up|Count of recent (past 30 days) male sexual partners.|12 months|||Sexual Partners||Standard Deviation|Mean
124110|NCT00607269|Secondary|Self-reported Psychiatric Symptoms at 12-month Follow-up.|As measured by the General Severity Index (GSI), a summary domain included on the Brief Symptom Inventory. The GSI combines information on both the number of symptoms described and the severity of those symptoms. Lower values on the GSI indicate less severe symptoms. Normative non-patient populations have been shown to have average GSI scores with a mean of 0.30 and a standard deviation of 0.31. Normative outpatient psychiatric patients have demonstrated GSI scores with a mean of 1.32 with a standard deviation of 0.72.|12 months|||Units of General Severity Index||Standard Deviation|Mean
124111|NCT00607269|Primary|Proportion of Level 1 (i.e., Drug Negative Urines and Alcohol Negative Breath) Clean Urine Samples Provided at 12-month Follow-up, by Condition.||24 Weeks|||Proportion of Lvl 1 Clean Urine Samples|||Number
124112|NCT00607269|Primary|Amount ($) Earned for Targeted Prosocial and Healthy Behaviors|Participants earned contingency management vouchers for targeted prosocial and healthy behaviors. 1 voucher = $1|24 Weeks|||$ Vouchers||Standard Deviation|Mean
124113|NCT00607243|Secondary|Cell-mediate Immunity||14 or 28 days||||||
124114|NCT00607243|Secondary|Antibody Response||14 or 28 days||||||
124115|NCT00607243|Primary|Adverse Reactions||0-28 days||||||
124116|NCT00607243|Primary|Cutaneous Take Reaction|The “take reaction”was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6–8. The vaccination site was photographed, and measures were taken.|7-9 day|||participants|||Number
124117|NCT00607126|Secondary|PASAT|Cognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance|baseline, mid, completion, 3 months post training|||units on a scale||Standard Error|Mean
124118|NCT00607126|Secondary|Fatigue|fatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning.|baseline, mid, completetion, 3 months post|||units on a scale||Standard Deviation|Mean
124119|NCT00607126|Secondary|Distance|distance assessed by 6 minute walk test|baseline, mid point, end and 12 weeks after training|||feet||Standard Deviation|Mean
124120|NCT00607126|Primary|Walking Speed as Assessed by 25' Timed Walk|This is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.|at beginning,mid point, end and 12 weeks after intervention|||seconds||Standard Deviation|Mean
124121|NCT00607113|Primary|Net Change Relative to Baseline in Tumor Blood Flow|Tumor blood flow (ml/min/100gm) determined by functional computed tomography (CT). Functional computed tomography (CT) at baseline, after first and third cycles (21 day cycles). Change (percentage) calculated as tumor blood flow measured at baseline compared to tumor blood flow measurement taken at end of Cycle 1, week 3 (21 days), and again at end of Cycle 3, Week 9 (63 days).|Baseline to end of Cycle 3 (63 days)|||ml/min/100gm||Standard Deviation|Mean
124122|NCT00607087|Secondary|Total Daily Bolus Insulin Dose|dose of every increment administered for example before meals|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||Units||Standard Deviation|Mean
124123|NCT00607087|Secondary|Total Daily Basal Insulin Infusion|dose of the basal insulin regimen administered throughout the 24-hour period|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||Units||Standard Deviation|Mean
124124|NCT00607087|Secondary|Glycosylated Hemoglobin: HbA1c|Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage||Standard Deviation|Mean
124125|NCT00607087|Secondary|Time Interval Between Infusion Set Changes in Routine|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~Changes in routine correspond to interval between changes according to patient use."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||hours||Standard Deviation|Mean
124408|NCT00604708|Primary|GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56|GMT: geometric mean of PRNT50|Day 56|PP Population: All randomized subjects without any major protocol deviations as assessed during a Data Review Meeting. Subjects who were randomized incorrectly or took the wrong study medications were also excluded.||titers||Standard Deviation|Geometric Mean
124126|NCT00607087|Secondary|Time Interval Between Infusion Set Changes: All Changes|"Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event).~All changes include all the changes whatever the reason such as routine or requested by occurrence of events."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||hours||Standard Deviation|Mean
124127|NCT00607087|Secondary|Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site|"Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment.~Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment.~Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection.~Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||patients|||Number
124128|NCT00607087|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year|Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events in patient-year||Standard Error|Mean
124129|NCT00607087|Secondary|Rate of Severe Symptomatic Hypoglycemia Per Patient-year|"Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following:~the event was associated with a measured blood glucose level below 36 mg/dL~or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events in patient-year||Standard Error|Mean
124130|NCT00607087|Secondary|Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year|Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events in patient-year||Standard Error|Mean
124131|NCT00607087|Secondary|Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
124132|NCT00607087|Secondary|Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis|"Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria).~Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and >1.5 mmol/l"|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
124133|NCT00607087|Secondary|Monthly Rate of Confirmed Infusion Set Occlusion||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
124134|NCT00607087|Secondary|Percentage of Patients With at Least One Confirmed Infusion Set Occlusion|"Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
124135|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia||over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
124136|NCT00607087|Secondary|Percentage of Patients With at Least One Unexplained Hyperglycemia|Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
124137|NCT00607087|Secondary|Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||events per patient per month||Standard Error|Mean
124138|NCT00607087|Primary|Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion|"Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason.~Pump infusion set occlusion defined by at least one of the following items:~pump occlusion alarm,~patient observation of an occlusion, spontaneously or because of elevated blood glucose value."|over 13 weeks of each treatment period|Analysis was performed on the Intention To Treat (ITT) population. The Intent-To-Treat population is composed of all randomized patients having received the 3 insulins (Insulin glulisine, aspart and lispro) N=256 patients: (sequence 1: N=86, sequence 2: N=86; sequence 3: N=84 patients).||percentage of patients||95% Confidence Interval|Number
124139|NCT00607048|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose up to a maximum of 8 cycles (6 months)|Data was not summarized as Human antihuman responses to CP-870893 were all below the limit of quantitation (endpoint titer of 4.32).|||||
124140|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: Human Leukocyte Antigen (HLA-DR) PD0, PDmax|Assess activity of B cells in presence of CP-870893. HLA-DR is a component of the Major Histocompatibility Complex in humans and presents antigens for recognition by the immune system. Agents that engage CD40 have been reported to increase HLA-DR expression; increased HLA-DR expression may serve as a marker for CD40 binding by CP-870893. Positive values may indicate greater presence of cells associated with potential for antibody production. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
124141|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD86 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD86 is a protein expressed on antigen-presenting cells and provides co-stimulatory signals for T cell (role in cell-modulated immunity) activation. Agents that engage CD40 have been reported to increase CD86 expression; increased CD86 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
124142|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54 PD0, PDmax|Assess activity of B cells in presence of CP-870893. CD54 is an intercellular adhesion molecule. When activated, leukocytes bind to endothelial cells via CD54 and then transmigrate into tissues. Agents that engage CD40 have been reported to increase CD54 expression; increased CD54 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate potential for increased immune response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
124143|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD23 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD23 is a low-affinity receptor that has a role in transportation in antibody feedback regulation. Agents that engage CD40 have been reported to increase CD23 expression; increased CD23 expression may, therefore, serve as a marker for CD40 binding by CP-870893. Higher numbers may indicate a potential for increased antibody response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
124144|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD40 PD0, PDmax|Assess activity of B cells in the presence of CP-870893. CD40 is a costimulatory protein and is a target for CP-870893. Measurement of CD40 on white blood cells provides a measure of target modulation by CP-870893. Higher numbers may indicate potential for increased activation of antigen presenting cells. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set; N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
124162|NCT00606931|Secondary|Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy|"Serious Adverse Events are defined as events that~Are fatal or life-threatening~Require in-patient hospitalization or prolong hospitalization~Result in permanent or significant disability/incapacity~Result in congenital abnormality/birth defect"|Within one week of completing PET-guided biopsy|||Participants|||Number
124409|NCT00604708|Secondary|Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age||Day 56||||||
124410|NCT00604708|Secondary|Immunogenicity at Day 56 for North America vs. Europe||Day 56||||||
124145|NCT00607048|Secondary|Change in Bone Marrow Derived Cells (B Cell) Surface Markers: CD19 Pre-dose Percentage (PD0), Maximum Post-dose Percentage (PDmax)|Assess activity of B cells (involved in production of antibodies) in presence of CP-870893. Clusters of differentiation (CD) are specific types of proteins on cell surface. CD19 is a B cell antigen receptor and is used to quantitate changes in proportion of B cells in peripheral blood as a consequence of therapy. Higher numbers may indicate a greater presence of CD19 on cell surface with increased potential for antigen response. Percentage of cells reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, 6, 24, and 48 hours postdose|Biomarker data analysis set: All enrolled participants who started treatment and who had baseline and sufficient on-study samples to provide interpretable results. N=Number of participants contributing to the mean.||percentage of cells||Standard Deviation|Mean
124146|NCT00607048|Secondary|Change in Cytokine Concentrations of Tumor Necrosis Factor Alpha (TNF Alpha): CYTO0, CYTOMAX|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set. CYTO0 values = the lower limit of quantitation (LLOQ).||pg/mL||Standard Deviation|Mean
124147|NCT00607048|Secondary|Change in Cytokine Concentrations of Interleukin 6 (IL 6): Pre-dose Concentration (CYTO0), Maximum Post-dose Concentration (CYTOMAX)|Concentrations reported as the mean of the pre-dose values and the mean of the maximum post-dose values to show change. An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction.|Schedule A Cycle 1 / Day 3 and Schedule B Cycle 1 / Day 8: predose, end of infusion, 1 , 2, 4, 6, 24, and 48 hours postdose|Pharmacokinetic data analysis set.||picograms per milliliter (pg/mL)||Standard Deviation|Mean
124148|NCT00607048|Secondary|Tumor Response of Partial Response (PR) and Complete Response CR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD.|Schedule A and Schedule B: Baseline and Day 21 of every even numbered cycle up to a maximum of 8 cycles (6 months)|All response-evaluable population: included all participants who had measurable disease, a baseline tumor assessment and who started treatment were considered evaluable for analysis of tumor response.||participants|||Number
124149|NCT00607048|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast was estimated using non-compartmental methods on the sequence of sample measurements. Mean of individual observed AUClast values measured as nanograms multiplied by micrograms per milliliter (ng*mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set; N=number of participants who did not have pre-dose levels of CP-870893.||hr*mcg/mL||Standard Deviation|Mean
124150|NCT00607048|Secondary|Maximum Observed Serum Concentration (Cmax)|Mean of individual observed Cmax values measured as micrograms per milliliter (mcg/mL).|Schedule A Day 3 of each 21 Day Cycle, Schedule B Day 8 of each 21 Day Cycle: Pre-dose, 5 minutes after end of infusion, and 2, 6, and 24 hours (hrs) post-dose up to a maximum of 8 cycles (6 months)|Pharmacokinetic data analysis set: all enrolled participants who started treatment and had baseline and sufficient on-study samples to provide interpretable results. N=number of participants who did not have pre-dose levels of CP-870893.||mcg/mL||Standard Deviation|Mean
124151|NCT00607048|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)|Any of the following during first cycle of treatment and attributable to CP-870893: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for ≥7 days; Gr 3 or 4 febrile neutropenia (ANC <1000/mm^3, fever ≥38.5 degrees Celsius; platelets ≤25,000 cells/mm^3); ≥Gr 3 non-hematological adverse event despite optimal supportive care; ≥Gr 3 cytokine release syndrome or acute infusion reaction; failure to recover to Gr <1 toxicity after delaying next cycle by maximum of 2 weeks; Day 3 or 8 ANC <1000 cells/mm^3 or platelets <80000 cells/mm^3, or non-hematologic toxicity ≥Gr 2.|Schedule (Sch) A Cycle 1 / Day 3 or Schedule B Cycle 1 / Day 8 up to Cycle 1 / Day 21|Safety population: all participants who received at least 1 dose of study treatment.||participants|||Number
124152|NCT00606944|Secondary|Postoperative Complication||at postoperative day 30||||||
124153|NCT00606944|Secondary|Quality of Life|measured by SF-36|at postoperative day 30||||||
124154|NCT00606944|Secondary|Pain|score measured by the Visual Analog Scale|at postoperative day 30||||||
124155|NCT00606944|Secondary|Readmission Rate||at postoperative day 30||||||
124156|NCT00606944|Primary|Recovery|"recovery criteria must include all of the following~Tolerance of consecutive 3 soft bland diet~Unassisted ambulation~No necessity of analgesics~Afebrile without major complication"|at discharge||||||
124157|NCT00606944|Primary|Postoperative Complication During the First Admission||at discharge||||||
124158|NCT00606944|Primary|Quality of Life|measured by SF-36|at discharge||||||
124159|NCT00606944|Primary|Pain|score measured by the Visual Analog Scale|at discharge||||||
124160|NCT00606944|Primary|the Length of Hospital Stay|"discharge criteria~Tolerance of consecutive 3 soft bland diet~Unassisted ambulation~No necessity of analgesics~Afebrile without major complication~Willing to discharge"|at discharge|1 mortality case was excluded for analysis in the ERP group||day||Inter-Quartile Range|Median
124161|NCT00606931|Other Pre-specified|Number of Participants Who Tolerated the PET-Guided Biopsy Procedure|Participants who could tolerate the procedure and complete it. This was ascertained by patient feedback questionnaire asking for overall discomfort rating from 0 to 5, where 0 is no discomfort and 5 was assigned to acute discomfort that prevented subject from completing the procedure.|Within one week of completing PET-guided biopsy|||Participants|||Number
124182|NCT00606580|Secondary|Number of Subjects With a Relapse on or After Day 42||Day 168|||participants|||Number
124411|NCT00604708|Secondary|Immunogenicity at Day 28||Day 28||||||
124163|NCT00606931|Primary|Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.|"Success in completion of the PET guided biopsy of a suspicious lesion was determined by~Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR~Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent)."|within two days of obtaining histopathology of the lesion biopsied|All participants who completed the PET-guided biopsy for a suspicious lesions. 24 lesions were biopsied in 19 participants||Number of lesions|||Number
124164|NCT00606905|Primary|Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies||20 weeks gestation|47 women who achieved an index pregnancy, defined as the first pregnancy in the study, unless it resulted in a noneuploid miscarriage, ectopic, molar pregnancy or genetic termination, were analyzed.||Successful pregnancies|||Number
124165|NCT00606892|Secondary|Changes in Systolic and Diastolic Blood Pressure|The average peak change (change score = maximum post dose score minus predose baseline) in systolic and diastolic blood pressure after nicotine infusion.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).||mm Hg||Standard Error|Mean
124166|NCT00606892|Secondary|Heart Rate|The average peak change (change score = maximum post dose score minus predose baseline) in heart rate was calculated.|30 minutes after each nicotine infusion|Changes in heart rate, systolic and diastolic blood pressure during the experimental sessions were analyzed on all subjects who completed both experimental sessions (n=12).||beats per minute||Standard Error|Mean
124167|NCT00606892|Primary|Subjective Responses to Intravenous Nicotine|"The Drug Effects Questionaire( DEQ) is a 7-item psychometric that measures the following subjective categories: 'drug strength',' high', 'feels stimulated', 'good effects', 'bad effects', 'head rush', and 'like the drug'. Smokers rated each item on a 100 millimeter scale from not at all (a score of 0) to extremely with a maximum score of 100."|30 minutes after each nicotine infusion|All participants who complete all interventions.||millimeters||Standard Error|Mean
124168|NCT00606892|Secondary|Cotinine Levels|Subject Cotinine Levels before each laboratory session.|Before each laboratory session on day 5|Subjects finishing the complete study. (n=12)||ng/mL||Standard Deviation|Mean
124169|NCT00606892|Secondary|Mean Reaction Time (RT) on Modified Stroop Task.|A Modified stroop task was used to assess attentional responses to smoking and negative affect cues. Cues were presented as blue, red or green text. Subjects completed 2 counterbalanced blocks (60 trials per block). One block contained smoking cues and neutral cues. The other block contained negative affect cues and a different set of matched neutral cues. The 2 blocks were administered twice during each experimental session - prior to nicotine infusion, and 30 mins after the last nicotine infusion (2 hrs and 45 mins after medication dosing). The Stroop effect is a differential RT when identifying the colors of words presented as neutral cues vs. emotional cues (i.e. smoking or negative affect cues).|pre-nicotine, and 30 min after last nicotine infusion (Post-Nicotine)|Data from all subjects who completed both experimental sessions (nicotine infusion after 4 days of placebo and also 4 days of varneicline, n=12) are presented. RT's < 100 ms, or > 1501 ms were excluded from the analysis (>3 SD's of the mean). The data presented are the mean RT's to identifying word colors under each treatment condition.||milliseconds||Standard Deviation|Mean
124170|NCT00606801|Secondary|Performance on the Modified Stroop Task (Cocaine-Stroop)|The Cocaine-Stroop task measures attention capture (attentional bias) secondary to cocaine cues; (Stroop effect - calculated as the difference between mean RT on cocaine words and mean RT on control words). Subjects completed 2 counterbalanced blocks (150 trials per block). One block contained 15 cocaine words and neutral words in a mixed order. The other block contained 15 control words matched in length and frequency to cocaine words, and a different set of neutral words. Subjects were required to indicate the colors in which the words were written as quickly and accurately as possible. Reaction times for identification of word color was measured. In addition, the difference in RT to words following cocaine and control words were measured (carry-over effect). Complete data for 3 participants (2 placebo and 1 galantamine) were not capture due to experimenter and computer errors.|Baseline, Day 5 and Day 10|||milliseconds||Standard Deviation|Mean
124171|NCT00606801|Secondary|Performance on the Sustained Attention to Response Task (SART).|"The SART is a Go / NoGo task measuring the ability to activate or inhibit responses. Cocaine users are know to have deficits in response inhibition on such tasks. The number of errors on NoGo and Go trials, as well as the mean reaction time (RT in milliseconds) for correct responses on Go Trials were measured.~Complete data for 3 subjects in the Placebo group, and for 1 subject in the galantamine group were not capture do to experimenter and computer errors."|Baseline, Day 5 and Day 10|Participants analyzed are those that completed the treatment phase.||milliseconds||Standard Deviation|Mean
124172|NCT00606801|Primary|Performance on 3 Cognitive Tests From the Cambridge Neuropsychological Test Automated Battery (CANTAB) - RVIP, PAL and PRM.|Rapid Visual Processing test (RVIP) is a measure of sustained attention with a small working memory component that is sensitive to cholinergic enhancers. In the RVIP, subjects must detect either odd or even 3 digit sequences appearing in a box in a pseudo-random order at 100 digits per minute. Reaction time (RT) to correct answers, total hits, correct rejections and A' (sensitivity to target sequences) were determined. Paired Associate Learning (PAL) measures visual memory and new learning by testing a the ability to remember the initial location of a pattern after it is re-presented in the middle of the screen. Errors result in a reminder presentation of the original location. The stages completed and number of errors are measures of interest. Pattern Recognition Memory (PRM) tests visual pattern recognition memory in a two choice forced discrimination paradigm. 12 visual patterns are presented, then the subject must choose between each of these patterns and a novel pattern.|Baseline, Day 5 and Day 10|There were a total of 28 completers, 14 for each treatment group. However, CANTAB data was not stored on the hard drive for one subject in the Galantamine group.||milliseconds||Standard Deviation|Mean
124183|NCT00606580|Secondary|Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42||Day 42|mITT dataset||Ulcerated lesions|Participants||Number
124184|NCT00606580|Secondary|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse|Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward,|Day 168|mITT dataset||participants|||Number
124412|NCT00604708|Secondary|Safety and Adverse Events||until Day 56||||||
124173|NCT00606684|Secondary|Time to >= 100 Milliliter (mL) Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieve >=100 mL increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to >= 100mL increase from Baseline (on Day 1) is defined as the time until the first post-dose FEV1 (on Day 1) is >= 100mL above Baseline FEV1. Time to >= 100mL increase from Baseline (on Day 1) was calculated only if there was at least one non-missing FEV1 value recorded within the first hour of dosing. Time to >= 100mL increase from Baseline was assessed over the 0-4 time period and only used lung function data recorded up to 6 hours post the Day 1 dose. Participants who did not achieve >= 100mL increase from Baseline over this time period were censored.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.||Minutes||Full Range|Median
124174|NCT00606684|Secondary|Time to >= 12% Increase From Baseline in FEV1 (0-4 Hours Post-dose)|Forced expiratory volume in one second (FEV1) is a measure of lung function defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieved a >=12% increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 on Day 1.Time to >= 12% increase from Baseline (on Day 1) is defined as the time when the first post-dose FEV1 (on Day 1) is >=12% above Baseline FEV1. Time to >= 12% increase from Baseline was assessed over the 0-4 hour time period and only used lung function data recorded up to 6 hours post the Day 1 dose.|Baseline and Day 1|ITT Population. Only participants available at the indicated time points were assessed.||Minutes||Full Range|Median
124175|NCT00606684|Secondary|Time-adjusted Area Under the Curve (AUC) (i.e. Weighted Mean Change From Baseline) for 24 Hour Serial FEV1 on Days 1 and 28|Weighted mean was derived by calculating the AUC, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24 hour serial FEV1 measures on Day 1 and Day 28 minus the Baseline value. Serial FEV1 measurements were taken on Day 1 and Day 28 (post-dose FEV1 after 5, 15, 30 minutes and 1, 2, 4, 8, 12, 23 and 24 hours). AUC was calculated only when there was at least 3 non-missing values between 0 and 24 hours and must have a value at 23 or 24 hours. Analysis performed used a repeated measures model with covariates of treatment, baseline, sex, age, smoking status (at Screening), reversibility stratum, Day (nominal), day by Baseline, and day by treatment interactions.|Baseline to Day 28|ITT Population. The number of participants presented represents those with data available at either of time points being presented. The numbers given in the category titles represent the number of participants with data available at the time point given.||Liters||Standard Error|Least Squares Mean
124176|NCT00606684|Primary|Mean Change From Baseline in Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours after dosing on Day 28 and the Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline in trough FEV1 was calculated as the value on Day 29 minus the value at Baseline. Analysis was performed using Analysis of Covariance (ANCOVA) using Last Observation Carried Forward (LOCF) with covariates of baseline, sex, age, smoking status (at screening), reversibility stratum, and treatment (trt).|Baseline (BL) and Day 29|Intent-to-Treat (ITT) Population: all participants who were randomized to trt and received >= 1 dose of study medication. When the endpoint was missing, the last valid non-missing on-trt, post-BL trough assessment was used instead. Only those participants available at the specified time points without missing covariate information were analyzed.||Liters||Standard Error|Least Squares Mean
124177|NCT00606632|Secondary|Safety Evaluation of 124I -cG250 in Patients With Renal Masses||6 months||||||
124178|NCT00606632|Primary|Reading of Diagnostic CT Imaging in Renal Masses to Decide on the Presence or Absence of ccRCC.||6 months||||||
124179|NCT00606632|Primary|Sensitivity - Proportion of Participant Determinded to Have Clear Cell Renal Carcinoma (ccRCC) by PET/CT.|Proportion of participants with ccRCC that were correctly identified on the PET/CT images.|6 months|ITD (Intend-to-Diagnose)observed case: All subjects who were enrolled and infused with the investigational product and who had a “standard-of-truth” (histopathology) result and images evaluated as readable by the blinded readers||Proportion of participants||95% Confidence Interval|Number
124180|NCT00606593|Secondary|Mean Total Sleep Time (TST)|"TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).~Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.||minutes||Standard Deviation|Mean
124181|NCT00606593|Primary|Mean Wake Time After Sleep Onset (WASO)|"WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.~Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included)."|2 treatment nights|Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.||minutes||Standard Deviation|Mean
124190|NCT00606580|Secondary|Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up||Days 42, 49, and 98|mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion.||percentage of participants||95% Confidence Interval|Number
124191|NCT00606580|Secondary|Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse|For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42.|Day 42|mITT dataset||percentage of participants||95% Confidence Interval|Number
124192|NCT00606580|Secondary|Final Clinical Cure Rate (Per Protocol Dataset)|Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure.|Day 42, 98, and 168|Per protocol – all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure.||participants|||Number
124193|NCT00606580|Primary|Final Clinical Cure Rate|"Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows:~Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation.~Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98.~Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168.~Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse."|Day 42, 98, and 168|Modified intention-to-treat (mITT) – all subjects randomized who received at least one treatment of study drug.||participants|||Number
124194|NCT00606554|Secondary|Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)|This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.|Duration of weaning (median 2 days)|||Participants|||Number
124195|NCT00606554|Secondary|Number of Spontaneous Breathing Trials Prior to Extubation||duration of study||||||
124196|NCT00606554|Secondary|Sedation Requirements||duration of study||||||
124197|NCT00606554|Secondary|Inpatient Mortality|proportion of patients in each arm who died in the hospital|28 days|ITT||Participants|||Number
124198|NCT00606554|Secondary|Duration of Hospitalization||duration of study||||||
124199|NCT00606554|Secondary|Duration of Mechanical Ventilation||duration of study||||||
124200|NCT00606554|Secondary|Duration of ICU Stay||duration of study||||||
124201|NCT00606554|Primary|Duration of Weaning|Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.|Continuous (median weaning duration was 2 days)|ITT||Days||Inter-Quartile Range|Median
124202|NCT00606502|Secondary|Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib||Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal).|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Pralatrexate or Erlotinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.~Grade 3 = Severe~Grade 4 = Life-threatening or disabling"||Treated Participants|||Number
124203|NCT00606502|Secondary|Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib|PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Patients who were alive without a disease response assessment of PD as of the data cut-off date were censored at the last disease assessment date or the date of randomization, whichever was later. Patients with no response assessments after baseline were censored at date of randomization resulting in a duration of PFS of 1 day.||months||95% Confidence Interval|Median
124204|NCT00606502|Secondary|Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib|Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).|Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment.|Based on all treated patients with measurable disease at baseline. Patients who were declared unevaluable for response were considered nonresponders and were included in the calculation of response rate. Patients were unevaluable if they were off-treatment prior to first response assessment, never received treatment or had unconfirmed responses.||Participants|||Number
124205|NCT00606502|Primary|Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib|OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date.|Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.|||Months Survival||95% Confidence Interval|Median
124206|NCT00606489|Primary|Temperature|Area under the curve temperature from baseline to hour 24 following initiation of treatment.|0 to 24 hours|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.||Degree Celcius times hours (AUC-T)||Standard Error|Least Squares Mean
124413|NCT00604708|Primary|SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56|SCR: anti-JEV neutralizing antibody titer ≥1:10|Day 56|Per Protocol Population: all randomized subjects without any protocol deviations as defined in the Statistical Analysis Plan||percentage of participants|||Number
124208|NCT00605384|Secondary|Number of Participants With HBs Seroconversion (HBsAg Loss and Presence of HBsAb) at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAb = HBsAg antibodies. HBs Seroconversion = HBsAg loss and presence of HBseAb|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
124209|NCT00605384|Secondary|Number of Participants With Hepatitis-B-Virus Surface Antigen of the (HBsAg) Loss at Weeks 48 and 96|Hepatitis B surface antigen (HBsAg) = a part of the hepatitis B virus that, when in the blood, is an early marker of infection|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
124210|NCT00605384|Secondary|Number of Participants Who Were HBeAg-positive at Baseline With HBe Seroconversion at Weeks 48 and 96|HBe seroconversion = HBeAg loss and presence of hepatitis B e-antibody (HBeAb)|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
124211|NCT00605384|Secondary|Number of Participants Who Were Hepatitis B E-antigen (HBeAg)-Positive at Baseline With Loss of HBeAg at Weeks 48 and 96|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication.|Baseline, Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.||Participants|||Number
124212|NCT00605384|Secondary|Number of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieved ALT Normalization (≤ 1 x ULN) at Weeks 48 and 96||Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||Participants|||Number
124213|NCT00605384|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Weeks 48 and 96|by PCR, using the Roche COBAS®TaqMan - HPS assay|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints was analyzed.||log10||Standard Deviation|Mean
124214|NCT00605384|Secondary|HBV DNA Values at Weeks 48 and 96|Number of Participants with HBV DNA <LLD (4.8); LLD to <50; 50 to <172; 172 to <1,720; 1,720 to <17,200; and ≥17,200 IU/mL (<LLD (28); 28 to <300; 300 to <1,000; 1,000 to <10,000; 10,000 to <100,000; and ≥100,000 copies/mL by PCR, using the Roche COBAS®TaqMan - HPS assay|Weeks 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
124215|NCT00605384|Secondary|Number of Participants Who Achieved HBV DNA < the Lower Limit of Detection (LLD) at Weeks 48 and 96|by PCR, using the Roche for the Roche COBAS® TaqMan - HPS assay. LLD = 4.8 IU/mL (approximately 28 copies/mL)|Week 48, Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
124216|NCT00605384|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.|Day 1 through end of treatment (Week 100 +/- 5 days)|All treated participants. Timeframe for Outcome Measure revised due to study termination. (Study Completion Date=February 2009).||participants|||Number
124217|NCT00605384|Secondary|Number of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 96|by PCR, using the Roche COBAS®TaqMan - HPS assay; HBV DNA < 50 IU/mL = approximately 300 copies/mL.|Week 96|Due to early study termination, none of the efficacy endpoints were analyzed.||participants|||Number
124218|NCT00605384|Primary|Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48|using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay, by Polymerase Chain Reaction (PCR); HBV DNA < 50 IU/mL = approximately 300 copies/mL|Week 48|Due to early study termination, none of the efficacy endpoints were analyzed.||Participants|||Number
124219|NCT00605345|Secondary|Incidence of RBC Transfusions|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis performed with the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.||participants|||Number
124220|NCT00605345|Secondary|Percentage of Participants Needing Dose Adjustments|Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).|Up to 28 weeks|Analysis was performed on the safety population.||percentage of participants|||Number
124221|NCT00605345|Secondary|Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)|Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.|Weeks 16-28|Analysis was performed using the intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.||days||Standard Deviation|Mean
124222|NCT00605345|Secondary|Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)||Weeks 16-28|Analysis performed with intent to treat (ITT) population, which includes all participants receiving at least one dose of the study drug.||percentage of participants|||Number
124223|NCT00605345|Secondary|Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)|Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.|Baseline to 28 weeks|Analysis performed in the Intent toTreat (ITT) population, which includes all participants receiving at least one dose of the study drug.||g/dL||Standard Deviation|Mean
124224|NCT00605345|Primary|The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range|Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 – 12 g/dL.|Weeks 16-28|Analysis was performed in the per protocol (PP) population.||percentage of participants||95% Confidence Interval|Number
124225|NCT00605306|Secondary|Levels of Serum Cortisol Over Time|At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants||mmol/L||Standard Deviation|Mean
124226|NCT00605306|Secondary|Levels of Plasma Glucose Over Time|At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants||mmol/L||Standard Deviation|Mean
124227|NCT00605306|Secondary|Levels of Serum Potassium Over Time|At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.|Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).|All participants||mmol/L||Standard Deviation|Mean
124228|NCT00605306|Primary|Participants With Adverse Events|"An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.~A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above."|15 days|All participants||participants|||Number
124229|NCT00605293|Secondary|Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP|RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|DTP (Week 0 to 15) up to EEP (Week 16 to 23)|ITT population||percentage of participants|||Number
124230|NCT00605293|Secondary|Percentage of Participants Who Required Dose Adjustments During the DTP and EEP||DTP (Week 0 to 15) and EEP (Week 16 to 23)|"Safety population included all those participants who were treated with at least one dose of the trial medication and had a safety follow-up, whether withdrawn prematurely or not. Here, n = participants who were evaluable for each category, for respective arm groups."||percentage of participants|||Number
124231|NCT00605293|Secondary|Mean Time Spent in Hb Range 10-12 g/dL||SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)|ITT population. Here, n = participants who were evaluable for each category, for respective arm groups.||days||Standard Deviation|Mean
124232|NCT00605293|Secondary|Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP|Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.|EEP (Week 16 to 23)|ITT population||percentage of participants|||Number
124233|NCT00605293|Secondary|Change in Hb Concentrations Between Baseline SVP and the EEP|Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).|SVP (Week -4 to -1), EEP (Week 16 to 23)|ITT population.||g/dL||Standard Deviation|Mean
124234|NCT00605293|Primary|Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP|Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.|EEP (Week 16 to 23)|Per Protocol (PP) population was as a subset of the ITT population who completed the study without any major protocol deviations.||percentage of participants||95% Confidence Interval|Number
124235|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 2|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|2 years|FAS2 population||Participants|||Number
124236|NCT00605280|Secondary|Number of Participants Requiring Focal or Grid Laser Treatment During Year 1|Included focal laser coagulation, focal laser photocoagulation, panretinal laser photocoagulation, retinal laser coagulation, and retinal laser photocoagulation|1 year|MITT1 population||Participants|||Number
124237|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 2 Years|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 2|FAS2 population. LOCF.||Scores on a scale||Standard Deviation|Mean
124238|NCT00605280|Secondary|Change From Baseline in Mean VA Score at 1 Year|Changes in VA monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS chart with participants at a 4-meter distance from chart. Distance VA expressed as an ETDRS score (number of letters correctly read) ranging from 0 to 60, where higher ETDRS scores represented better vision. Change from baseline for each patient equaled the visual acuity obtained at the observation minus the visual acuity at baseline.|Baseline, Year 1|MITT1 population. LOCF.||scores on a scale||Standard Deviation|Mean
124259|NCT00605267|Secondary|Bone Mineral Density (BMD) Cervical Thighbone|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.|Assessed at baseline and after 24 weeks of treatment|Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks – BMD percentage at baseline||PercentageBMD=Patient'sBMD/standard BMD)||Standard Deviation|Mean
124239|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
124240|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 2 Years|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 2|FAS2 population. Number of participants analyzed (N) = participants with evaluable data. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
124241|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Decrease in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and FA assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where a decrease in the step or retinopathy level indicated an improvement.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
124242|NCT00605280|Secondary|Number of Eyes With a 2 or More Step Increase in Degree of Retinopathy at 1 Year|Retinopathy changes were monitored using fundus photography and fluorescein angiograph (FA) assessments. An Independent Reading Center, using trained graders, evaluated the presence of retinopathy using a modified 12-step version of the ETDRS Final Retinopathy Severity Scale, that ranged from step 1 (retinopathy level of 10 or 12) to step 12 (retinopathy level of 85A or 85B) where an increase in the step or retinopathy level indicated a worsening of the condition.|Baseline, Year 1|Evaluable participants from MITT1 population. Only 1 eye per participant was assessed in this study. LOCF.||Eyes|||Number
124243|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|FAS2 population. LOCF.||Participants|||Number
124244|NCT00605280|Secondary|Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 1|MITT1 population. LOCF.||Participants|||Number
124245|NCT00605280|Secondary|Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years|Refraction and best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Year 2|Full Analysis Set (FAS)2 population:participants who had same treatment for 102 weeks (pegaptanib sodium or sham on/before Week 96) with baseline VA assessment, who met the following: had at least 1 post baseline VA within 2 years, before entry into the Year 3 open-label extension phase, or before withdrawing from the study prior to Week 102. LOCF.||Participants|||Number
124246|NCT00605280|Primary|Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year|Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts|Baseline, Year 1|Modified Intent-to-Treat (MITT)1 population:participants with at least 1 dose of study treatment who completed baseline VA, had at least 1 post baseline VA assessment within 1 year; 2 sites not analyzed due to Good Clinical Practice deviations; the 0.03 and 0.003mg pegaptanib arms not analyzed for efficacy. Last Observation Carried Forward (LOCF).||Participants|||Number
124247|NCT00605267|Secondary|Anastrozole Plasma Concentrations (Cmin)|Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.|Assessed at week 12|||ng/mL||Full Range|Geometric Mean
124248|NCT00605267|Secondary|Endocrine Subscale (ES)|"Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.~Score range: 0-72"|Assessed at baseline and after 24 weeks of treatment|Difference of Endocrine Subscale (ES) = ES at 24 weeks – ES at baseline.||ES score||Standard Deviation|Mean
124249|NCT00605267|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B)|"Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.~FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).~Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.~Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI."|Assessed at baseline and after 24 weeks of treatment|"Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.~PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS."||Trial Outcome Index (TOI) (Prorated)||Standard Deviation|Mean
124250|NCT00605267|Secondary|Histopathological Response Rate (HRR)|Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)|Assessed at baseline and after 24 weeks of treatment|||Percentage of Participants|||Number
124251|NCT00605267|Secondary|Human Epidermal Growth Factor Receptor 2 (HER2) Status|HER2 status in the ITT population is categorized as Positive or Negative|Assessed at baseline and after 24 weeks of treatment|||Participants|||Number
124252|NCT00605267|Secondary|Progesterone Receptor (PgR) Status|PgR status in the ITT population is categorized as Positive or Negative.|Assessed at baseline and after 24 weeks of treatment|||Participants|||Number
124260|NCT00605267|Secondary|Bone Mineral Density (BMD) Lumbar Spine|Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.|Assessed at baseline and after 24 weeks of treatment|The standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100||PercentageBMD=Patient's BMD/standard BMD||Standard Deviation|Mean
124261|NCT00605267|Primary|Best Overall Response Rate (BORR) (MRI/CT)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).~CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|||Percentage of Participants|||Number
124262|NCT00605267|Primary|Best Overall Response Rate (BORR) (US)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|||Participants|||Number
124263|NCT00605267|Primary|Best Overall Response Rate (BORR) (Calliper)|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).~CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 weeks|"The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period.~At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"||Percentage of Participants|||Number
124264|NCT00606320|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness. CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation|||scores on a scale||Standard Deviation|Mean
124265|NCT00606320|Primary|Young Mania Rating Scale (YMRS)|YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior. YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome). Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated.|baseline (Day 1 of preceding study), Day 154 or at discontinuation|||scores on a scale||Standard Deviation|Mean
124266|NCT00606281|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP), Severity of Illness Score (Mania)|"CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill).~Using LOCF datasets, change in CGI-BP severity of illness score (mania) from baseline (Day 1) to endpoint (Day 21) was evaluated through ANCOVA."|Day1, Day21|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on a scale||Standard Error|Least Squares Mean
124267|NCT00606281|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, change in YMRS total score from baseline (Day 1) to endpoint (Day 21) was evaluated through analysis of covariance(ANCOVA).~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Day1, Day21|Full analysis set (FAS): The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on a scale||Standard Error|Least Squares Mean
124268|NCT00606229|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Sevirity of Illness Score (Mania)|"Mean change from baseline (Day 1) to endpoint in Clinical Global Impression -Bipolar Version (CGI-BP) severity of illness score (mania)~The severity of manic symptoms on a scale of 1 (normal, not ill) to 7 (very severely ill)"|Day 1 and Daty 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)||scores on a scale||Standard Deviation|Mean
124284|NCT00606021|Secondary|Number of Participants With Adverse Events (AEs) During Overall Period|The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.|First dose of study drug during IP through overall study completion (up to 34.3) months|Participants who took at least one dose of study drug during IP, and randomized to maintenance phase.||participants|||Number
124414|NCT00604695|Secondary|Safety Endpoint: Number of Deaths||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
124269|NCT00606229|Primary|Young Mania Rating Scale (YMRS)|"Mean change from baseline (Day 1) to endpoint in the YMRS total score~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) elevated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~Total score range is 0 to 60, and the higher value represents worsen."|Day 1 and Day 168 or time of discontinuation|Results obtained from the LOCF dataset of 40 subjects of the Full Analysis Set (FAS) (excluding 1 subject whose post-dose data of efficacy endpoint were not available from the 41 treated subjects)||scores on a scale||Standard Deviation|Mean
124270|NCT00606177|Secondary|Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)|"Using LOCF datasets, descriptive statistics of actual values for change of CGI-BP severity of illness score (mania) from baseline (Day 1 of preceding study) to endpoint (Day 154) were calculated for each treatment group.~CGI-BP severity of illness is a scale for overall evaluation of the severity of bipolar disorder; it comprises 3 components—mania, depression, and overall bipolar illness.~CGI-BP severity of illness score (mania) ranges form 1 (normal, not ill) to 7 (very severely ill)."|Baseline (Day 1 of preceding study), Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on scale||Standard Deviation|Mean
124271|NCT00606177|Primary|Young Mania Rating Scale (YMRS)|"Using LOCF datasets, descriptive statistics of actual values for changes of YMRS total scores from baseline (Day 1 of preceding study) to endpoint (Day 154) was calculated for each treatment group.~YMRS is composed of 11 evaluation items with 5 rating levels each. Items rated on a scale of 0 to 4 (comprising 5 rating levels of one point each) are 1) levated mood, 2) increased motor activity/energy, 3) sexual interest, 4) sleep, 7) language-thought disorder, 10) appearance, and 11) insight. Items rated on a scale of 0 to 8 (comprising 5 rating levels of two points each) are 5) irritability, 6) speech (rate and amount), 8) content, and 9) disruptive-aggressive behavior.~YMRS ranges from 0 (best possible outcome) to 60 (worst possible outcome)."|Baseline (Day 1 of preceding study) , Day 154 or at discontinuation|FAS: The FAS consisted of subjects who had received at least one dose of investigational product and for whom the post-dosing efficacy parameter data had been obtained. Cases of GCP violation were excluded from analysis.||scores on a scale||Standard Deviation|Mean
124272|NCT00606138|Secondary|Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment||Month 6|||number of PDR complications|||Number
124273|NCT00606138|Secondary|Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing||Week 1, 2, 4; Month 2, 3, 4, 5, 6||||||
124274|NCT00606138|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters||Week 4; Month 6|||lines of vision gained||Standard Deviation|Mean
124275|NCT00606138|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||Week 1, 2, 4; Month 2, 3, 4, 5, 6||||||
124276|NCT00606138|Primary|Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination||Month 6|||number of events|||Number
124277|NCT00606138|Primary|The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)||Week 4; Month 6|||percentage of change (mean)||Standard Deviation|Mean
124278|NCT00606138|Primary|The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)|This is a measurement of how much change in neovascularization has occurred, using the Optomap FA readings to calculate the increase or decrease in surface area of the retina that is affected by neovascularization.|Week 4; Month 6|||percentage of change in area (mean)||Standard Deviation|Mean
124279|NCT00606086|Primary|EVR (Early Virologic Response)|Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.|At 12 weeks of treatment|One hundred forty subjects were randomized, only 133 subjects received at least one dose of study drug. Subjects who did not receive at least one dose of study drug were removed from the analysis.||percentage of participants|||Number
124280|NCT00606034|Secondary|Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)|Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.|Baseline versus 1 year|per protocol||percent satisfaction||Standard Deviation|Mean
124281|NCT00606034|Secondary|Percentage of Time Spent in Hypoglycemia|For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.|baseline versus 12 months|ITT (LOCF for 1 subject)||percent of time spent in hypoglycemia||Standard Deviation|Mean
124282|NCT00606034|Primary|Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)|HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.|1 year|Per Protocol||HbA1c percentage||Standard Deviation|Mean
124283|NCT00606021|Secondary|Tumor Response Rate and Disease Control Rate After Induction Phase (IP)|Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Randomization to measured PD up to 31.4 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.||percentage of participants||95% Confidence Interval|Number
125437|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after second treatment|Safety||cm||Full Range|Mean
124285|NCT00606021|Secondary|Overall Survival During Overall Period (IP + MP)|Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.|First dose of study drug during IP to PD or date of death from any cause up to 34.1 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.||months||95% Confidence Interval|Median
124286|NCT00606021|Secondary|Overall Survival During Maintenance Phase|Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.|Randomization to PD or date of death from any cause up to 31.3 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.||months||95% Confidence Interval|Median
124287|NCT00606021|Secondary|Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])|Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.|First dose of study drug during IP to PD or date of death from any cause up to 33.6 months|Participants who took at least one dose of study drug during IP and had measurable or evaluable lesions at baseline (assessment before induction phase) and post baseline.||months||95% Confidence Interval|Median
124288|NCT00606021|Primary|Progression Free Survival During Maintenance Phase|Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.|Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months|Participants who were randomized into maintenance phase and had measurable or evaluable lesions at baseline (last assessment before randomization) and post-baseline.||months||95% Confidence Interval|Median
124289|NCT00606008|Secondary|Number of Participants With Related Grade 3 and Greater Adverse Events|To evaluate toxicities associated with sunitinib treatment (grade 3 and greater toxicities).|12 Months|All participants||Participants|||Number
124290|NCT00606008|Secondary|Best Overall Response|To estimate best response rates (proportion of patients who ever had a radiographic response equal to or better than stable disease during course assessment).|12 Months|All participants||Participants|||Number
124291|NCT00606008|Primary|Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse|Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.|6 Months|All participants||Participants|||Number
124292|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Drinking Status|Number of participants with responders of Sertraline to determine whether drinking status is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124293|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124294|NCT00605917|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug|Number of participants with responders of Sertraline to determine whether with or without concomitant drug is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124295|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124296|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124297|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
125650|NCT00593606|Primary|Change in Creatinine|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
124298|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed.||participants|||Number
124299|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124300|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124301|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124302|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124303|NCT00605917|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124304|NCT00605917|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||events|||Number
124305|NCT00605917|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.||participants|||Number
124306|NCT00605904|Primary|Alcohol Craving Rating in Response to Yohimbine Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)||Units on a scale||Standard Error|Mean
124307|NCT00605904|Primary|Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)||Units on a scale||Standard Error|Mean
124308|NCT00605904|Primary|Alcohol Craving Rating in Response to Saline Infusion|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving.|180 minutes after the start of the infusion|The analyses included only those subjects who completed all three types of infusions (saline, meta-Chlorophenylpiperazine, and yohimbine)||Units on a scale||Standard Error|Mean
124309|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124310|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Age|Number of participants with responders of Sertraline to determine whether age is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124311|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not|Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124312|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.|Number of participants with responders of Sertraline to determine whether with or without complication is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124313|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient|Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124314|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride|Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124315|NCT00605865|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity|Number of participants with responders of Sertraline to determine whether target disease severity is significant factor|Baseline up to 16 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124316|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124317|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124318|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124319|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124320|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124321|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124322|NCT00605865|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)|Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124323|NCT00605865|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 16 weeks|The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.||events|||Number
124324|NCT00605865|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 16 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.||participants|||Number
124325|NCT00605839|Secondary|Metabolic Control||6 months||||||
124326|NCT00605839|Secondary|Competence in Diabetes Management||6 months||||||
124327|NCT00605839|Secondary|Quality of Life||6 months||||||
124415|NCT00604695|Secondary|Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias||Through 30days following primary percutaneous coronary intervention|Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)||participants|||Number
124328|NCT00605839|Primary|Quality of Parent-child Relationship|The Cornell Parent Behavior Description Scale was used to measure the antecedents and consequences of children’s perceptions of the behavior of their parents towards them. Each of 14 subscales is scored from 0-10. The potential range of the total score is therefore 0 (fewest behaviors) to 140 (most behaviors). We used the total score, which is equivalent to the sums of the subscales, and calculated the change from baseline to 6 months. The range of the change is given as a 95% CI. A change of zero would indicate no change. A positive number is a worsening , and a negative number indicates an improvement.|Change from baseline to 6 months. Please see above for a description of how the change score should be interpreted.|Everyone who completed the study||units on a scale||95% Confidence Interval|Mean
124329|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)|Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124330|NCT00605813|Secondary|Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies|Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor|Baseline up to 52 weeks|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).||participants|||Number
124331|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124332|NCT00605813|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor|Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||participants|||Number
124333|NCT00605813|Primary|Number of Participants of Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline up to 52 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Sertraline.||events|||Number
124334|NCT00605813|Primary|Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert||Baseline up to 52 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.||events|||Number
124335|NCT00605722|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Up to 107 Weeks|Safety population included all participants who received at least one dose of study drug.||participants|||Number
124336|NCT00605722|Secondary|Overall Survival (OS)|OS was defined as the time period in months from the start of study drug treatment to death.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||months||95% Confidence Interval|Median
124337|NCT00605722|Secondary|Progression-free Survival (PFS)|PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug. Participants were censored at the last follow-up visit.||months||95% Confidence Interval|Median
124338|NCT00605722|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression. Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||Months||95% Confidence Interval|Median
124339|NCT00605722|Secondary|Disease Control Rate (DCR)|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||Percentage of participants||95% Confidence Interval|Number
125651|NCT00593606|Primary|Change in Chloride|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
124340|NCT00605722|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR). Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Event driven (median follow-up 12 months)|Intent-to-treat population included all participants who received study drug.||percentage of participants||95% Confidence Interval|Number
124341|NCT00605722|Primary|Percentage of Participants With Progression-free Survival (PFS)|Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug. Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 16|Intent-to-treat population included all participants who received study drug. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease.||percentage of participants||95% Confidence Interval|Number
124342|NCT00605657|Secondary|To Determine Whether the Treatment Alters, in Favorable Directions, Laboratory Markers of ALPS (e.g., Number of DNT Cells, Immunoglobin Levels, Vitamin B12 Levels, IL-10 Levels, Autoantibody Titers, Fas Mediated Apoptosis)||3 monthly (12 week) intervals|outcome measure not assessed because 0 participants had a response|||||
124343|NCT00605657|Primary|Number of Participants With Response|Reduction of lymph node and/or spleen size measured by CT imaging, or physical exam and abdominal ultrasound. A clinical response is defined as a greater than 40% reduction in lymph node size and/or greater than 40% reduction in spleen size. A CT scan with contrast measured lymph node size as well as spleen size.|3 monthly (12 week) intervals|||participants|||Number
124344|NCT00605540|Primary|Health Status|Saint George’s Respiratory Questionnaire (SGRQ)was used to evaluate patient's health status. SGRQ includes three domains: symptoms, activities and impact of the disease. Each domain has a minimum score (zero) and maximum (662.5, 1209.1, and 2117.8, respectively). A total score is also calculated based on the results of three domains, with a score maximum of 3989.4. The total score is referred to as the percentage achieved by the patient related to this maximum score. Minimum score means there is no impairment in the health status and high score means maximum dysfunction.|Baseline and after three years|||Percentage of total score||Standard Deviation|Mean
124345|NCT00605540|Primary|Dyspnea|Dyspnea was evaluated by Medical Research Council scale (MRC). MRC scale consists of only five items and it is based on activities that cause dyspnea. The patient reports the degree of dyspnea by choosing a value between 1 and 5. A higher number indicates greater sensation of dyspnea.|Baseline and after three years|||Scores on a scale||Inter-Quartile Range|Median
124346|NCT00605540|Primary|Body Composition|Body composition was evaluated by Body Mass Index (BMI), which is dividing weight in kilograms by height in square meters.|Baseline and after three years|||Kg/m^2||Inter-Quartile Range|Median
124347|NCT00605540|Primary|Exercise Tolerance|Tolerance exercise was evaluated by six-minute walking distance(6MWD)according to the American Thoracic Society guidelines.Patients were instructed to walk, attempting to cover as much ground as possible within 6 min. A research assistant timed the walk, and standardized verbal encouragement was given.|Baseline and after three years|||meters||Standard Deviation|Mean
124348|NCT00605540|Primary|Forced Expiratory Volume in the First Second (FEV1)|FEV1 values were measured by Spirometry using the KOKO Spirometer, before and 15 minutes after the inhalation of 400mcg of salbutamol.|Baseline and after three years|The sampling frame for this study was consecutive COPD patients recruited from the outpatient clinic of Botucatu Medical School.||Percentage predicted||Inter-Quartile Range|Median
124349|NCT00605475|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs), Adverse Events (AE) Above 5% Frequency|An adverse event is any unwanted event, whether related to study drug or not occurring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline to End of Study (56[+/-2] and 168 [+/- 5] days after dosing for Cohort 1 and Cohorts 2-4, respectively)|All randomized participants who received study medication were included in the Safety Analysis||Participants|||Number
124350|NCT00605475|Secondary|β-cell Function as Measured by the Homeostatic Model Assessment (HOMA-β )|β cell function is measured by the Homeostatic Model Assessment(HOMA-β) using a computer to model β cell function and insulin sensitivity . β cell function is related to Insulin Sensitivity (HOMA-%S) and is the reciprocal of insulin resistance (100/S%). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) – 3.5] where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||percent β-cell Function||Standard Error|Geometric Mean
124361|NCT00605475|Secondary|Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol*h/L||Standard Error|Least Squares Mean
124351|NCT00605475|Secondary|Insulin Resistance as Measured by the Homeostatic Model Assessment (HOMA-IR)|Insulin Resistance is measured via the Homeostatic Model Assessment (HOMA-IR) using a computer to model insulin sensitivity. Insulin Sensitivity (HOMA-%S), where 100% is normal, is the reciprocal of insulin resistance (100/S%). HOMA IR = [fasting insulin (μU/mL)] x [fasting plasma glucose (mmol/L)] / 22.5 where fasting insulin (or glucose) was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||units on a scale||Standard Error|Geometric Mean
124352|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Fructosamine Level|Blood was drawn to measure change in plasma Fructosamine Level, from baseline to Day 14, 28, 56, 84, 126 and End of Study ( defined as the final available post-randomization assessment up to the last regularly scheduled visit at Day 168 [+/- 5]). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 14, Day 28, Day 56, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||µmol/L||Standard Error|Least Squares Mean
124353|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Glucose Following Oral Glucose Tolerance Test ( OGTT )|Mean Change in Peak Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Change from baseline assessed at Day 28 and 84. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||mmol/L||Standard Error|Least Squares Mean
124354|NCT00605475|Secondary|Insulinogenic Index, 0 - 30 Minutes|"Insulinogenic index (0-30 min)~[Change in insulin (0-30 min) (μIU/mL)] / [Change in glucose (0-30 min) (mg/dL)]~[insulin (μIU/mL) at 30 min – insulin (μIU/mL) at 0 min] / [glucose (mg/dL) at 30 min – glucose (mg/dL) at 0 min), where insulin (or glucose) at 0 min was defined as the arithmetic mean of the -15, -10 and 0 min pre-glucose load values. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||units on a scale||Standard Error|Geometric Mean
124355|NCT00605475|Secondary|Insulin Sensitivity Index ( ISI ) at Day 28, Day 48|Insulin sensitivity index (ISI) = 10000 / [fasting insulin (μIU/mL) x fasting glucose (mg/dL) x mean 2 hour insulin(μIU/mL) x mean 2 hour glucose (mg/dL)]1/2 where mean 2 hour insulin (or glucose) was defined as the insulin (or glucose)AUC(0-2 hr) divided by the time period (2 hr). In normal subjects the mean score ± SE is 0.366 ± 0.029. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed on log transformed data.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||units on a scale||Standard Error|Geometric Mean
124356|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ), 0 - 4 Hours|Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. The mean ISR over 0 - 4 hours was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol/min/m^2||Standard Error|Least Squares Mean
124357|NCT00605475|Secondary|Mean Insulin Secretion Rate ( ISR ) Relative to Glucose, 0 - 4 Hours|"Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Mean ISR relative to glucose over 0-4 hours was calculated as follows:~Mean ISR relative to glucose = mean ISR / (glucose AUC/time interval). The mean ISR was computed as an AUC (area under the curve) using the linear trapezoidal rule divided by the corresponding time interval. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed."|Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
124358|NCT00605475|Secondary|Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin and proinsulin levels were measured. The insulin/proinsulin level was calculated by dividing the insulin level by the proinsulin level. Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol/pmol||Standard Error|Least Squares Mean
124359|NCT00605475|Primary|Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )|Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||mmol*h/L||Standard Error|Least Squares Mean
124360|NCT00605475|Secondary|Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Glucagon levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol*h/L||Standard Error|Least Squares Mean
124362|NCT00605475|Secondary|Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )|Blood samples were drawn after an overnight fast and OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||µIU*h/mL||Standard Error|Least Squares Mean
124363|NCT00605475|Primary|Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)|Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||percent||Standard Error|Least Squares Mean
124364|NCT00605475|Secondary|Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)|Blood samples were drawn after an overnight fast and standard OGTT at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. C-peptide levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.|Baseline, Day 28, Day 84|All randomized participants who received study drug were included in the intent to treat population (ITT). Last observation carried forward (LOCF) was used to impute missing values.||pmol*h/L||Standard Error|Least Squares Mean
124365|NCT00605423|Secondary|Change in IOP From Baseline|IOP stands for intra ocular pressure|6 mos|||mmHg||Standard Deviation|Mean
124366|NCT00605423|Secondary|Number of Patients Developing Cataracts||6 mos|||participants|||Number
124367|NCT00605423|Primary|Mean Change From Baseline in Visual Acuity|Visual acuity is measured using ETDRS charts at 4 meters.|6 mos|||ETDRS letters||Standard Deviation|Mean
124368|NCT00605202|Primary|Plasma Potassium|Plasma potassium measured with indirect ion specific electrode method|Baseline and 2 weeks|||mmol/l||Standard Deviation|Mean
124369|NCT00605176|Secondary|Local Skin Reactions|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve)|At all visits - from Baseline to End of study (Week 14)|All participants were evaluated for local skin reactions (LSR) at every visit. Summary of LSR - area under the curve (AUC) of sum of LSR Scores (days). ITT population. The time period for the AUC extends to 8 weeks after the end of treatment (Week 14). Only subjects who received treatment in both treatment cycles are included in this analysis.||units on a scale * days||Standard Deviation|Mean
124370|NCT00605176|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions.|From baseline to End of Study the Week 14 visit|Intent to treat (ITT) Last Observation Carried Forward (LOCF)||percent change||Full Range|Median
124371|NCT00605176|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).||participants|||Number
124372|NCT00605176|Primary|Number of Participants With Complete Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or ‘subclinical’ lesion that had not been identified at Baseline.|End of Study the Week 14 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF, primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).||participants|||Number
124373|NCT00605150|Secondary|Occurrence of Unacceptable Side Effects After Treatment||6 months||||||
124374|NCT00605150|Primary|Progression|Progression of liver cancer|6 months|Number of participants enrolled||participants|||Number
124375|NCT00605085|Secondary|SCR and GMT of Subjects With Concomitant Vaccinations||until Day 56||||||
124376|NCT00605085|Secondary|Changes in Laboratory Parameters||until Day 56||||||
124377|NCT00605085|Secondary|Rates of Serious Adverse Events and Medically Attended Adverse Events||until Day 56||||||
124378|NCT00605085|Primary|Safety and Tolerability up to Day 56|calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)|Day 56|Safety Population||percentage of participants with AEs|||Number
124379|NCT00605072|Primary|Cognitive Assessment: Forward Digit Span Test|This test consists of series of digits of increasing length, some of which are recited as presented, and some of which are to be recited in reversed order. The forward digit span score ranges from 0 (ie cannot repeat two digits) to 8 ( participant can repeat up to 8 digits)|Baseline-12 months|||number of digits repeated||Standard Error|Least Squares Mean
124380|NCT00605072|Primary|Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall|This is a 12-item list learning test in which individuals are presented three learning and recall trials followed by a delayed recall and 24 item recognition test. The HVLT-R has been identified as an ideal memory measure for elderly patients, and appropriate reliability and validity have been shown in older individuals. The test score is the number of correct answers in the delayed recall ( score range 0-12)|Baseline-12 months|||number words remembered||Standard Error|Least Squares Mean
124381|NCT00605072|Secondary|Blood Flow Velocity, Sitting|This reports the change in the least square mean from baseline to 12 months, adjusted for age|Baseline-12 months|||cm/sec||Standard Error|Least Squares Mean
125652|NCT00593606|Primary|Change in Calcium|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mg/dl||Standard Deviation|Mean
124382|NCT00605072|Secondary|Blood Pressure Outcome: Systolic BP|Blood pressure was measured as follows: the participant was in the sitting position, rested for 5 minutes, no caffeine or smoking 2 hours prior to measurement, using appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference), correct cuff placement (1-2 inches above brachial pulse on bare arm), and the bell of the stethoscope. The systolic blood pressure was defined as the pressure corresponding to the first korotkoff sounds (K1) and the diastolic as the pressure corresponding to the last korotkoff sound (K5). Blood pressure was measured in both arms and recorded|Baseline-12 months|||mm Hg||Standard Error|Least Squares Mean
124383|NCT00605072|Primary|Cognitive Assessment: Trail Making Test Part B|This test requires the connection of sequentially numbered circles (A), and the connection of circles marked by numbers and letters in alternating sequence (B). This test is considered a benchmark of executive function. The test score is the time required to complete the task in seconds.|Baseline-12 months|||seconds||Standard Error|Least Squares Mean
124384|NCT00605033|Primary|Response Rate|Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.|Assessed by Day 7 of double-blind, double-dummy treatment period.|Analysis of primary outcome was done on the intention-to-treat (ITT) population, defined as all randomized subjects who took at least one dose of study medication and provided at least one valid post-baseline assessment.||Percentage of participants|||Number
124385|NCT00604968|Secondary|Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment|The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).|Of the 25 total patients, 12 were hospitalized during the study.||days|||Number
124386|NCT00604968|Secondary|Duration of Overall Survival|Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival.|Time of treatment until death, up to the time that all participants ended treatment|||months||95% Confidence Interval|Median
124387|NCT00604968|Secondary|Time to Progression|"Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria):~Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease.~Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions."|Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Of the 25 patients in the study 3 patients had non-measurable disease and could not be included in the progression analysis.||months||95% Confidence Interval|Median
124388|NCT00604968|Secondary|Duration of Response|"Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study.~Response can be partial or complete (as previously defined), whichever status is recorded first."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Three patients showed Partial Response according to RECIST criteria.||weeks||Full Range|Median
124389|NCT00604968|Secondary|Time to Response|Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first.|Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|Only 3 patients had measureable time to response||Weeks||Full Range|Median
124390|NCT00604968|Secondary|Number of Patients Requiring Dose Reduction|The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc.|Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).|||participants|||Number
124391|NCT00604968|Secondary|Number of Patients With Progressive Disease (PD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions~WHO PD criteria required increase in size of existing lesions or appearance of new lesions."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.||participants|||Number
124392|NCT00604968|Secondary|Number of Patients With Partial Response (PR) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST PR criteria required >=30% decrease in certain target lesions & no increase in size of non-target lesions or appearance of new lesions~WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks"|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.||participants|||Number
124393|NCT00604968|Secondary|Number of Patients With Stable Disease (SD) as Best Response|"Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.~RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions.~WHO response criteria for SD required no significant change for at least 8 weeks."|Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.||participants|||Number
124394|NCT00604968|Primary|Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).|Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.|Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).|||Months||95% Confidence Interval|Median
124395|NCT00604851|Secondary|Unscheduled Heathcare Contacts||Baseline and 24 weeks||||||
124396|NCT00604851|Secondary|Lung Function||Baseline and 24 weeks||||||
124397|NCT00604851|Secondary|GER Symptoms||Baseline and 24 weeks||||||
124398|NCT00604851|Secondary|Asthma Symptom and Control Scores||Baseline and 24 weeks||||||
124399|NCT00604851|Primary|Change in Asthma Control Questionnaire Score at the 24 Week Visit.|The Asthma Control Questionnaire contains 7 items that are scored on a 7 point scale (range is 0 to 6). The scores are then summed and divided by 7 to reveal an overall score. A lower score indicates better asthma control. The results reflect the difference in the Asthma Control Questionnaire Score between baseline (randomization visit) and 24 weeks of treatment.|Baseline and 24 weeks|||Units on a scale||95% Confidence Interval|Mean
124400|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Apparent Half-life (Apparent t½)|Preliminary pharmacokinetics data; Apparent half-life (t½)|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||Hours||Standard Deviation|Mean
124401|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax)|Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||Hours||Full Range|Median
124402|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Maximum Concentration (Cmax)|Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||ng/mL||Standard Deviation|Mean
124403|NCT00604812|Secondary|Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))|Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot|24 Hours|Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.||ng hr/mL||Standard Deviation|Mean
124404|NCT00604812|Primary|Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)|24 Hours|All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability.||Participants|||Number
124405|NCT00604721|Secondary|Median Overall Survival (OS)|Overall survival has been defined as time from the start of treatment to death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy||months||95% Confidence Interval|Median
124406|NCT00604721|Secondary|Median Progression Free Survival (PFS)|Progression free survival has been defined as time from the start of treatment to disease progression or death as a result of any cause.|33 weeks|Participants who completed a full 21 day cycle of therapy||months||95% Confidence Interval|Median
124407|NCT00604721|Primary|Number of Participants With Radiographic Objective Response (OR)|"To ascertain the objective response rate (Complete Response + Partial Response [CR+PR]) of patients with the single-agent AZD6244. Our study utilized Response Evaluation Criteria in Solid Tumors (RECIST) to evaluate response.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|33 weeks|Participants who completed a full 21 day cycle of therapy||participants|||Number
125653|NCT00593606|Primary|Change in Blood Urea Nitrogen|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmol/l||Standard Deviation|Mean
124418|NCT00604695|Secondary|Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients||participants|||Number
124419|NCT00604695|Secondary|Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)|Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients||Corrected TIMI Frame Count (cTFC)||Inter-Quartile Range|Median
124420|NCT00604695|Secondary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery|Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."||participants|||Number
124421|NCT00604695|Secondary|Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."||participants|||Number
124422|NCT00604695|Primary|Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention||Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention|"Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.~Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1."||Percent diameter stenosis||Inter-Quartile Range|Median
124423|NCT00604669|Primary|Mortality|Mortality rate of those with hyperglycemia while on TPN duing the period of 1/01/06 to 12/31/06.|at the end of the chart review of all patients|||mortality rate|||Number
124424|NCT00604565|Primary|TOTAL NUMBER OF ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of events are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.||events|||Number
124425|NCT00604565|Primary|TOTAL NUMBER OF SUBJECTS WITH ADVERSE EVENTS|Incidence and seriousness of adverse events will be captured from date of randomization until study participation completion (up to 36 weeks). For the Primary Outcome Measure, total number of subjects affected are listed only. The details of the types of events that took place are reported in the Adverse Events section.|36 weeks|All subjects were included in the Safety Analysis population.||participants|||Number
124426|NCT00604552|Secondary|Evaluate the Occurrence of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events.||5 years||||||
124427|NCT00604552|Primary|Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion|Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion|5 year|All those treated on-label for the treatment of an AAA and followed out to 5 years.||participants|||Number
124428|NCT00604500|Primary|End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)|The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.|4-week Treatment Period|Completer Population, excluding 2 participants who used more than the labeled number of actuations.||Number of inhalers|||Number
124429|NCT00604500|Primary|Overall Discrepancy Size|Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.||Discrepancy Size Per 100 actuations|||Number
124430|NCT00604500|Primary|Overall Quartile Discrepancy Rate|"Quartile discrepancies refer to the difference between~the participant-recorded number of actuations and the participant-recorded~counter readout at each of the 4 weekly visit intervals [ie, quartiles] to~evaluate whether there was any difference in agreement over the life of~the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population."|4-week Treatment Period|Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.||discrepancies per 100 actuations|||Number
124431|NCT00604500|Primary|Overall Discrepancy Rate|Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).|4-week Treatment Period|Completer population, defined as participants who recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.||Overall discrepancies per 100 actuations|||Number
124432|NCT00604461|Secondary|Number of Months of Progression Free Survival (PFS)|The PFS is defined as the duration of time from the start of treatment to time of progression or death, whichever occurs first.|2 Years, 9 Months|All participants||Months||95% Confidence Interval|Median
124433|NCT00604461|Primary|Number of Participants With Partial Response (PR) of Target Lesions|Tumor response was assessed in 12 patients who had at least one follow-up computed tomography (CT) scan. Response Evaluation Criteria in Solid Tumors (RECIST) definition of Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 12 Months|All participants with baseline and at least one post-baseline target lesion measurement.||participants|||Number
124434|NCT00604383|Secondary|Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health.|Baseline, up to 36 months|All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values||units on a scale||Standard Deviation|Mean
124435|NCT00604383|Secondary|Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)|NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome).|Baseline, up to 36 months|All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.||units on a scale||Standard Deviation|Mean
124436|NCT00604383|Secondary|Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)|Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.||percentage of participants|||Number
124437|NCT00604383|Secondary|Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)|DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100.|Baseline through 36 months|All randomized participants who had no center involved or imminently threatened DME at baseline.||percentage of participants|||Number
124438|NCT00604383|Primary|Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period|SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100.|Baseline through 36 months|All randomized participants.||percentage of participants|||Number
124439|NCT00604279|Secondary|Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal|A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.|Day 92 or early withdrawal|Per Protocol Analysis Set.||Percentage of participants|||Number
124440|NCT00604279|Secondary|Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal|The self-administered sleep VAS scale (0-100 millimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set.||millimeter (mm)||Standard Deviation|Mean
124441|NCT00604279|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."||Units on scale||Standard Deviation|Mean
124442|NCT00604279|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal|This PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; <= 30, functioning so poorly as to require intensive supervision.|Baseline, Day 92 or early withdrawal|"Per Protocol Analysis Set. Here N (Number of Participants Analyzed) represents number of participants who were evaluable for this measure."||Units on scale||Standard Deviation|Mean
124443|NCT00604279|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.|Baseline, Day 92 or early withdrawal|Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations.||Units on scale||Standard Deviation|Mean
124444|NCT00604214|Secondary|Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint||Baseline through Day 28|Participants who received study drug.||percentage of participants|||Number
124445|NCT00604214|Other Pre-specified|Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28|Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.|Baseline through Day 28|Participants who received study drug.||percentage of participants|||Number
124446|NCT00604214|Secondary|Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180|SF-12 was used as an instrument to measure participants’ physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.|Baseline and Days 28 and 90 and 180|All randomized participants with SF-12 score data at the specified time points.||units on a scale||Standard Deviation|Median
124447|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180|The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D total score data at the specified time points.||units on a scale||Standard Deviation|Mean
124448|NCT00604214|Secondary|EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180|EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.|Baseline and Days 28 and 90 and 180|All randomized participants with EQ-5D VAS data at the specified time points.||units on a scale||Standard Deviation|Mean
124449|NCT00604214|Secondary|Median Survival Time||Day 180|All randomized participants excluding those with unknown mortality status at Day 180.||days||Full Range|Median
124450|NCT00604214|Secondary|180-Day Mortality|Expressed as percentage of participants who died from any cause at Day 180 endpoint.|Day 180|All randomized participants with known mortality status at Day 180.||percentage of participants|||Number
124451|NCT00604214|Secondary|90-Day Mortality|Expressed as percentage of participants who died from any cause at Day 90 endpoint.|Day 90|All randomized participants with known mortality status at Day 90.||percentage of participants|||Number
124452|NCT00604214|Secondary|Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.||units on a scale||Standard Deviation|Mean
124453|NCT00604214|Secondary|Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.||units on a scale||Standard Deviation|Mean
124454|NCT00604214|Secondary|Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28|Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.|Day 1 through Day 28|All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.||units on a scale||Standard Deviation|Mean
124455|NCT00604214|Secondary|28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency|Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).|Day 28|All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28.||percentage of participants|||Number
124456|NCT00604214|Primary|28-Day All-Cause Mortality|Expressed as percentage of participants who died from any cause at Day 28 endpoint.|Day 28|All randomized participants with known mortality status at Day 28.||percentage of participants|||Number
124457|NCT00604188|Secondary|Responders at Day 28|Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued.|28 days|ITT population||Participants|||Number
124458|NCT00604188|Secondary|Compliance Rate|Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment.|28 days|ITT population||Percentage of days||Standard Deviation|Mean
124459|NCT00604188|Secondary|Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric|"The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28.~The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis."|Baseline and 28 days|ITT population.||Score on a scale||Standard Error|Least Squares Mean
124460|NCT00604188|Secondary|Observer-rated Opioid Withdrawal Symptoms (OOWS)|The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with OOWS data reviewed for completeness and within visit date consistency were analyzed.||Score on a scale||Standard Deviation|Mean
124461|NCT00604188|Secondary|Self-reported Opioid Withdrawal Symptoms (SOWS)|SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28.|Baseline and 28 days|Participants with SOWS data reviewed for completeness and within visit date consistency were analyzed.||Score on a scale||Standard Deviation|Mean
124462|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)|Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use.|Days 3 to 28|ITT population||Participants|||Number
124463|NCT00604188|Secondary|Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)|Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28.|28 days|Participants with missing data were not included in the analysis.||Participants|||Number
124464|NCT00604188|Primary|Responders at Day 3|"Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders.~All participants that continued the study received Suboxone tablets on Day 3."|3 days|ITT population||Participants|||Number
124465|NCT00604175|Secondary|Change in CD4 Cell Count From Baseline|A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline.|Weeks 0, 4, 8, 12, 24, 28, 52 and 72|N=315 eligible participants who initiated intervention and had data available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=122; 92; 88. Week 8: n=119; 92; 90. Week 12: n=115; 87; 90. Week 24: n=117; 85; 88. Week 28: n=114; 89; 87. Week 52: n=108; 85; 87. Week 72: 105; 85; 88.||Cells/mm^3||Inter-Quartile Range|Median
124466|NCT00604175|Secondary|Change in Log10 HIV Viral Load (VL) From Baseline|A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline.|Weeks 0, 4, 12, 28, 52, and 72|N=315 eligible participants who initiated intervention and had HIV VL available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=123; 89; 88. Week 12: n=118; 89; 90. Week 28: n=118; 91; 87. Week 52: n=109; 85; 82. Week 72: n=105; 81; 83.||Log10 copies/mL||Inter-Quartile Range|Median
124467|NCT00604175|Secondary|Number of Participants With Laboratory Abnormalities of Grade 3 or Higher|Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.||Participants|||Number
124468|NCT00604175|Secondary|Number of Participants With Signs and Symptoms of Grade 3 or Higher|Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From baseline to up to Week 72|All eligible participants who received at least one vaccine.||Participants|||Number
124469|NCT00604175|Secondary|Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline|Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV18 at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=27; 11; 19. Week 72: n=25; 11; 19.||Log10 mMU/mL||Inter-Quartile Range|Median
124494|NCT00603993|Secondary|Presence of Morning Stiffness by Visit|The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.||participants|||Number
124470|NCT00604175|Secondary|Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline|Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV16 (HPV16+) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=40; 28; 24. Week 72: n=37; 25; 24.||Log10 mMU/mL||Inter-Quartile Range|Median
124471|NCT00604175|Secondary|Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline|Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV11 (HPV11+) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=20; 21; 17. Week 72: n=17; 18; 19.||Log10 mMU/mL||Inter-Quartile Range|Median
124472|NCT00604175|Secondary|Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline|Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6).|Weeks 0, 28, 72|All eligible participants who received at least one vaccine and were seropositive for HPV6 (HPV6+) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=52; n=33; n=36. Week 72: n=43; 31; 35.||Log10 mMU/mL||Inter-Quartile Range|Median
124473|NCT00604175|Secondary|HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline|HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (<24 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV18 (HPV18-) at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=86; 80; 69. Week 72: n=75; 73; 69.||mMU/mL||95% Confidence Interval|Geometric Mean
124474|NCT00604175|Secondary|HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline|HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV16 (HPV16-) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=73; 63; 64. Week 72: n=63; 59; 64.||mMU/mL||95% Confidence Interval|Geometric Mean
124475|NCT00604175|Secondary|HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline|HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (<16 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV11 (HPV11-) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=93; 70; 71. Week 72: n=83; 66; 69.||mMU/mL||95% Confidence Interval|Geometric Mean
124476|NCT00604175|Secondary|HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline|HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (<20 mMU/mL) at baseline.|Weeks 28, 72|All eligible participants who received at least one vaccine and were seronegative for HPV6 (HPV6-) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=60; 58; 52. Week 72: n=55; 53; 53.||mMU/mL||95% Confidence Interval|Geometric Mean
124477|NCT00604175|Primary|Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers <24 mMU/mL) at baseline to seropositive (HPV18 antibody titers >=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV18 at baseline who completed the vaccination series per protocol and had HPV18 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
124495|NCT00603993|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit|Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in CRP (mg/dL), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)|||mg/dL||Standard Deviation|Mean
125654|NCT00593606|Primary|Change in Alkaline Phosphatase|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Units/l||Standard Deviation|Mean
124478|NCT00604175|Primary|Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers <20 mMU/mL) at baseline to seropositive (HPV16 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV16 at baseline who completed the vaccination series per protocol and had HPV16 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
124479|NCT00604175|Primary|Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers <16 mMU/mL) at baseline to seropositive (HPV11 antibody titers >=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV11 at baseline who completed the vaccination series per protocol and had HPV11 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
124480|NCT00604175|Primary|Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series|Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers <20 mMU/mL) at baseline to seropositive (HPV6 antibody titers >=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.|Week 28|Per-protocol analysis including all participants seronegative to HPV6 at baseline who completed the vaccination series per protocol and had HPV6 titer available at Week 28.||Percentage of participants||95% Confidence Interval|Number
124481|NCT00604162|Primary|Specificity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.||Percentage of Participants||95% Confidence Interval|Number
124482|NCT00604162|Secondary|Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)||within 7 days||||||
124483|NCT00604162|Primary|Sensitivity of Capsule Endoscopy for Indicated Lesions|Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.|1 day|Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.||Percentage of Participants||95% Confidence Interval|Number
124484|NCT00604162|Primary|Number of Participants With Indicated Lesions Detected by Standard Colonoscopy|"Since the standard colonoscopy is the gold standard to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger."|1 day|Participants in the Accuracy Analysis successfully had both capsule endoscopy and colonoscopy.||participants|||Number
124485|NCT00604162|Secondary|Percentage of Excreted Colon Capsules||Within 7 days||||||
124486|NCT00604162|Secondary|Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy||within 7 days||||||
124487|NCT00604162|Secondary|Number, Type and Severity of Adverse Events||Within 7 days||||||
124488|NCT00604162|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:~poor cleansing level (Large amount of fecal residue.)~fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)~good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)~excellent cleansing level (No more than small bits of adherent feces.)"|1 day|||Percentage of Participants||95% Confidence Interval|Number
124489|NCT00604162|Primary|Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies|The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.|1 day|||participants|||Number
124490|NCT00604045|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0 to 80, with higher scores indicating more severe symptoms.|Pre-Treatment, Post-Treatment (after 4 weeks of treatment)|||units on a scale||Standard Deviation|Mean
124491|NCT00604019|Secondary|Safety, Arrythmia - Yes or no for Each Group||28 days||||||
124492|NCT00604019|Primary|Efficacy|Dead at 28 days|28 days|||participants|||Number
124493|NCT00603993|Secondary|Duration (Minutes) of the Presence of Morning Stiffness by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in the duration (minutes) of stiffness in the morning.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.||minutes||Standard Deviation|Mean
124554|NCT00603538|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.|The screening assay for anti-CP-751,871 antibodies was performed.|Day 1 of Cycles 1 (predose) and 4, and end of study|All participants were screened for the ADA.||participants|||Number
124496|NCT00603993|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities [0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so]), a component of the ACR criteria by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|||units on a scale||Standard Deviation|Mean
124497|NCT00603993|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)|||mm on a scale||Standard Deviation|Mean
124498|NCT00603993|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|||mm on a scale||Standard Deviation|Mean
124499|NCT00603993|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|||mm on a scale||Standard Deviation|Mean
124500|NCT00603993|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in SJC (max = 66), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)|||SJC||Standard Deviation|Mean
124501|NCT00603993|Secondary|Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 [NCT 00647491]; for subjects with rescue treatment, baseline is from Study M03-651 [NCT 00235872]) in TJC (max = 68), a component of the ACR criteria, by visit|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|||TJC||Standard Deviation|Mean
124502|NCT00603993|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)|Analysis was based on observed data.||participants|||Number
124503|NCT00603915|Secondary|Number of Participants With the Responses Outlined|"Complete Response (CR): disappearance of all clinical and radiological evidence of tumour.~Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease."|Measured every 2 cycles until the participant is off treatment.|||Participants|||Number
124504|NCT00603915|Primary|Progression Free Survival.|From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.|From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.|||Months||95% Confidence Interval|Mean
124505|NCT00603902|Secondary|Percent Change in Body Weight From Baseline to Week 52|The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
124506|NCT00603902|Primary|Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.~Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF||percentage of participants|||Number
124507|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application|||units on a scale||Full Range|Mean
124508|NCT00603889|Secondary|100 Mcg/ml Na-ASP-2 Intradermal Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application|||units on a scale||Full Range|Mean
124509|NCT00603889|Secondary|1000 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application|||units on a scale||Full Range|Mean
124510|NCT00603889|Primary|100 Mcg/ml Na-ASP-2 Prick-puncture Skin Test|"Mean grade of wheal reaction after 2 applications of the skin test reagent per participant. For each skin test reaction, the grade of the test was determined based on the mean of the longest and orthogonal diameters, which was then compared to the equivalent measurements of a histamine solution positive control that was applied at the same time as the test. Grading was as follows:~0 no discernible wheal~< ½ histamine diameter~≥ ½ histamine; < histamine diameter~= size of histamine control ± 1 mm~> histamine diameter; < 2x diameter~≥ 2x histamine control"|15 minutes after skin test application|||Units on a scale||Full Range|Mean
124511|NCT00603837|Primary|Neonatal Intensive Care Unit (NICU) Admission Temperature|Axillary temperature of the infant upon arrival to the neonatal intensive care unit.|At time of admission to the NICU - usually within 10-15 min of birth|||Celsius degrees||Standard Deviation|Mean
124512|NCT00603798|Secondary|Local Skin Reactions (LSR)|Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each visit. These included: Erythema, edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Summary of LSR - area under the curve (AUC) of sum of LSR scores (days).|The time period for the AUC extends to 8 weeks after the end of treatment (Week 17)|All participants were evaluated for local skin reactions (LSR) at every visit. The ITT population was used. Only subjects who received treatment in both cycles are included in the analysis.||units on a scale * days||Standard Deviation|Mean
124513|NCT00603798|Secondary|Percent Change From Baseline in AK Lesion Count|Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions. A negative percent change is better than a positive percent change.|At all visits - Baseline through the Week 17 EOS visit|Intent to treat (ITT) population using last observation carried forward (LOCF).||percentage of participants||Full Range|Median
124514|NCT00603798|Secondary|Number of Participants With Partial Clearance of AK Lesions|Subject status with respect to complete clearance of AK lesions at End of Study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline.|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. Imputations were made for missing data points using last observation carried forward (LOCF).||participants|||Number
124515|NCT00603798|Primary|Number of Participants With Complete Clearance of AK Lesions|"Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or subclinical lesion that had not been identified at Baseline."|End of Study the Week 17 visit|Efficacy analyses were conducted on the intent-to-treat (ITT) population. For the primary efficacy variable, imputations were made for missing data points using last observation carried forward (LOCF), primary analysis), taking all missed observations as failure (sensitivity analysis), and using observed cases only (supportive analysis).||participants|||Number
124516|NCT00603746|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
124517|NCT00603746|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
124518|NCT00603746|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
124519|NCT00603746|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||scores on a scale||Standard Deviation|Mean
124555|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)|IGF-BP3 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.||mg/L||Standard Deviation|Mean
124520|NCT00603746|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
124521|NCT00603746|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cells (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. For UG, the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
124522|NCT00603746|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
124523|NCT00603746|Secondary|Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8|Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
124524|NCT00603746|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
124525|NCT00603746|Secondary|Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8|Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
124526|NCT00603746|Secondary|Red Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
124527|NCT00603746|Secondary|Platelet Count and White Blood Cell Count at Baseline and Week 8|Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
124528|NCT00603746|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
124556|NCT00603538|Secondary|Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers.|Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study|Safety Analysis Set was defined as all participants who have received at least one dose of the study medication. n = number of subjects evaluable.||ng/L||Standard Deviation|Mean
124529|NCT00603746|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1||Standard Deviation|Mean
124530|NCT00603746|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage in the blood||Standard Deviation|Mean
124531|NCT00603746|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population||participants|||Number
124532|NCT00603746|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
124533|NCT00603746|Secondary|Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
124534|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
124535|NCT00603746|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
124536|NCT00603746|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124537|NCT00603746|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124731|NCT00603239|Secondary|Percentage of Patients Achieving HbA1c <= 7%|Percentage of intent-to-treat (ITT) patients who had HbA1c > 7% at baseline that decreased to <= 7% at endpoint (Week 26 or early discontinuation)|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||percentage of participants|||Number
124538|NCT00603746|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.||Liters||Standard Error|Least Squares Mean
124539|NCT00603733|Secondary|Frequency of Adverse Events|Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.|From baseline to week 24|Safety dataset for Active and Maintenance Phases||percentage of patients with TEAEs|||Number
124540|NCT00603733|Primary|Maintenance Phase: Proportion of Subjects Experiencing Relapse|Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy|Up to week 24|Per Protocol Analysis Set||% of subjects with relapse (90% CI)||90% Confidence Interval|Number
124541|NCT00603733|Primary|Active Phase: Proportion of Active Subjects Achieving Overall Improvement|"Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI).~Complete remission is defined as: i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings and iv) a Physician's Global Assessment (PGA) score of 0 or 1.~A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score."|From baseline to week 8|Per Protocol Analysis Set||percentage of participants||90% Confidence Interval|Number
124542|NCT00603642|Secondary|Rescue Medication(s)|Requirement for rescue medication(s) during treatment by the participant|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Participants|||Number
124543|NCT00603642|Secondary|Weeks With Platelet Count Between 50 and 200|Number of weeks with platelet count between 50 x 10^9/L and 200 x 10^9/L inclusive during week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Weeks||Standard Deviation|Mean
124544|NCT00603642|Secondary|Change From Baseline in Mean of Last 4 Weekly Platelet Counts|Change from baseline in the mean of the last 4 weekly platelet counts from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||10^9/L||Standard Deviation|Mean
124545|NCT00603642|Secondary|Increased Platelet Count From Baseline of at Least 20 x 10^9/L|An increase in platelet count of at least 20 x 10^9/L from baseline within the participant during the treatment period. Increase was calculated as the maximum observed platelet count during the treatment period minus the baseline platelet count.|Baseline, 12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Participants|||Number
124546|NCT00603642|Primary|Weeks With Weekly Platelet Response|Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10^9/L on a weekly scheduled dose day from week 2 to week 13.|12 weeks (Weeks 2 - 13)|Full Analysis Set, composed of all randomized participants who received at least 1 dose of romiplostim or placebo||Weeks||Inter-Quartile Range|Median
124547|NCT00603590|Secondary|LDL Cholesterol|Serum LDL cholesterol|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward||mg/dL||Standard Deviation|Mean
124548|NCT00603590|Secondary|Diastolic Blood Pressure|Mean of two seated diastolic blood pressures|One year|Analysis by intention to treat. Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward.||mm Hg||Standard Deviation|Mean
124549|NCT00603590|Primary|Systolic Blood Pressure|Systolic blood pressure. Mean of two seated measurements.|One year|Intention to treat Results shown here are based on 12 month observation. Analysis for final paper will be last observation carried forward||mm Hg||Standard Deviation|Mean
124550|NCT00603564|Secondary|PaO2/FiO2 Ratio Mantainance|the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement|1, 6, 12, 24 and 48 hours|||participants|||Number
124551|NCT00603564|Primary|Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315||on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315|||minute||Standard Deviation|Mean
124552|NCT00603538|Secondary|Progression-Free Survival (PFS)|PFS is the period from the registration to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to 6 cycles (1 cycle = 21 days)|Number of participants with defined event (all causality death or PD) was too few to conduct summary analysis.|||||
124553|NCT00603538|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline up to 6 cycles (1 cycle = 21 days)|Full Analysis Set (FAS) was defined as all participants who met all of the following criteria; 1) Those who were diagnosed with NSCLC, 2) Those who received at least one dose of the study treatment, and 3) Those who had efficacy data after the start of the study treatment.||participants|||Number
124557|NCT00603538|Secondary|Observed Accumulation Ratio (Rac)|The ratio of Cycle 4 AUCtau to Cycle 1 AUCtau|Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.||ratio||Standard Deviation|Mean
124558|NCT00603538|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)|AUCtau: AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sampling for the next cycle. AUCtau was calculated using the linear/log trapezoidal method.|Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.||mg*h/mL||Standard Deviation|Mean
124559|NCT00603538|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)|AUC(0-day22) : AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sampling for the next cycle. AUC(0-day22) was calculated using the linear/log trapezoidal method.|Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.||mg*h/L||Standard Deviation|Mean
124560|NCT00603538|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|Participants with sufficient sampling to capture the terminal disposition phase were analyzed.||hours||Standard Deviation|Mean
124561|NCT00603538|Secondary|Maximum Observed Concentration (Cmax) of CP-751,871||Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion|"The Pharmacokinetics Analysis Set was defined as all participants who started treatment and had sufficient information for estimation of pharmacokinetic parameters.~n = the number of participants analyzed"||mg/L||Standard Deviation|Mean
124562|NCT00603538|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) >=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other >=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for >=7 consecutive days or was complicated by fever (defined as a body temperature >38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.|Cycle 1|DLT Evaluation Set comprised of participants who were treated with CP-751,871. One participant in the 10 mg/kg cohort who discontinued from the study due to an adverse event occurred prior to CP-751,871 administration was excluded from this analysis set.||participants|||Number
124563|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Total neutrophils: 0.8, 1.6; Platelet count: 0.65, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
124564|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern During the Follow-up Period|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: ALT: NA, 2; ALP: NA, 1.5; TBIL: NA, 1.5; CO2/BCO: 0.85, 1.2; CK: NA, 2; GGT: NA, 2; Urea/BUN: NA, 1.5.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (maximum of 2 years)|AT Population. Only participants who withdrew from the DB Period and had evidence of contact with the site after the end of the DB Period and all participants who withdrew or completed the OL Period and had evidence of contact with the site after their end of OL date were analyzed.||Participants|||Number
124565|NCT00603525|Secondary|Number of Participants With a Positive JC Virus Test Result During the Follow-up Period|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. Positive JC Virus test result indicated presence of JC Virus.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124566|NCT00603525|Secondary|Time to First CD19+ B-cell Repopulation Relative to the First Dose and Last Dose of Ofatumumab|Time to first CD19+ B-cell repopulation (return to normal or baseline level) relative to the first dose was assessed only for those participants whose B-cells repopulated after receiving ofatumumab. Time to first CD19+ B-cell repopulation relative to the last dose of ofatumumab was assessed only for those participants whose B-cells repopulated during their last ofatumumab treatment course or follow-up.|From the first dose of ofatumumab until the last Follow-up Period visit (up to Week 248)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Months||Full Range|Median
124567|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range During the Follow-up Period|The reference ranges for immunoglobulins (LLN, ULN) are defined as: IgA (grams/Liter): 0.81, 4.63; IgG (grams/Liter): 6.94, 16.18; IgM (grams/Liter): 0.48, 2.71.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from LSLV)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124725|NCT00603239|Secondary|Change in Insulin Sensitivity.|Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||ratio||Standard Error|Least Squares Mean
124568|NCT00603525|Secondary|Number of Participants With Any Serious Adverse Event During the Follow-up Period|A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general SAE module for a list of SAEs.|From the last scheduled visit in the DB or OL Period until B-cells and circulating IgG had returned to normal or baseline levels (or maximum of 2 years from Last Subject Last Visit [LSLV])|Safety Follow-up Population: all participants who withdrew from the Double-blind Period and had evidence of contact with the site after the end of the Double-blind Period and all participants who withdrew or completed the Open-label Period and had evidence of contact with the site after their end of Open-label date.||Participants|||Number
124569|NCT00603525|Secondary|Number of Participants With Positive John Cunningham (JC) Virus Test Results at Baseline or Any Visit Post-baseline During the DB and OL Periods|Blood samples were collected for analysis of plasma/white blood cell JC Virus (JCV) using the polymerase chain reaction (PCR) assay. A positive JC Virus test result indicates the presence of JC Virus.|From basline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124570|NCT00603525|Secondary|Number of Participants With Immunoglobulin Values Outside the Reference Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline visit is defined as any visit after the date of infusion A during the specified treatment course. Reference ranges (LLN, ULN) used for immunoglobulins are: immunoglobulin A (IgA) (grams/Liter): 0.81, 4.63; immunoglobulin G (IgG) (grams/Liter): 6.94, 16.18; immunoglobulin M (IgM) (grams/Liter): 0.48, 2.71.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124571|NCT00603525|Secondary|Number of Participants With Vital Sign Data Outside the Clinical Concern Range at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|The baseline value for a treatment course is defined as the value before infusion A of each treatment course. The post-baseline visit is defined as any assessment during or after the start of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern for vital signs (Low, High) are: Diastolic blood pressure (DBP) (millimeters of mercury [mmHg]): 40, 110; Systolic blood pressure (SBP) (mmHg): 90, 170; Heart rate (beats per minute): 35, 120. LLN=lower limit of normal; ULN=upper limit of normal.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124572|NCT00603525|Secondary|Number of Participants With the Indicated Hematology Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to lower limit of normal], CC High [relative to upper limit of normal]) are: Eosinophils: NA, 2; Hematocrit (HCT): 0.75, 1.2; Hemoglobin (Hb): 0.75, 1.2; Monocytes: 0.2, 5 2; Neutrophils total (TNUE): 0.8, 1.6; Platelet count (PC): 0.65, 1.5; Red blood cell count (RBC): 0.7, 5 2; White blood cell count (WBC): 0.7, 1.6.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124573|NCT00603525|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern at Baseline or Any Visit Post-baseline, During the DB and OL Periods, by Ofatumumab Treatment Course|Only those parameters for which at least one value of clinical concern (CC) was reported are summarized. The baseline (BL) value for a treatment course is defined as the latest value on or before the date of infusion A of the treatment course. The post-baseline (PBL) visit is defined as any visit after the date of infusion A during the specified treatment course. Pre-defined limits of potential clinical concern (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) are: Albumin: 0.9, 1.5; Alanine amino transferase (ALT): NA, 2; Alkaline phosphatase (ALP): NA, 1.5; Aspartate amino transferase (AST): NA, 2; Bilirubin total (TBIL): NA, 1.5; Calcium: 0.85, 1.08; CO2 content/bicarbonate (BCO): 0.85, 1.2; Creatine kinase (CK): NA, 2; Creatinine: NA, 1.2; Gamma glutamyl transferase (GGT): NA, 2; Potassium: 0.9, 1.1; Urea/blood urea nitrogen (BUN): NA, 1.5; Uric acid: NA, 1.5.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124574|NCT00603525|Secondary|Number of Participants With a CD8+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD8+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124575|NCT00603525|Secondary|Number of Participants With a CD4+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point , During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD4+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124576|NCT00603525|Secondary|Number of Participants With a CD3+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at the Indicated Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD3+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 gill per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124577|NCT00603525|Secondary|Number of Participants With a CD19+ Cell Count Greater Than or Equal to the Lower Limit of Normal or the Baseline Value at Indicated the Time Point, During the DB and OL Periods, by Ofatumumab Treatment Course|The number of participants with a CD19+ cell count greater than or equal to the lower limit of normal (LLN; reference range 0.11 to 0.66 giga [10^9] per liter) or the baseline value (whichever was lower) is presented. The baseline assessment is defined as the start of the Double-blind Period.|From baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124578|NCT00603525|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings, During the OL Period|The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), during the OL Period are presented. An overall interpretation of the ECG was made by the investigator, or the investigator could delegate this task to a cardiologist, if applicable.|From DB Period completion (Week 24) until the completion of the OL Period, assessed up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Participants|||Number
124579|NCT00603525|Secondary|Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event, During the DB and OL Periods, by Ofatumumab Treatment Course|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=2%) and SAEs.|First treatment (Day 0) until the participant terminated the trial, assessed up to Week 144|AT Population||Participants|||Number
124580|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using CRP), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
124581|NCT00603525|Secondary|Number of Participants Who Achieved Remission or Low Disease Activity Based on DAS28 (Using ESR), During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. Remission is defined as a DAS28 score <2.6 at any time during the first 24 weeks of each treatment course. Low disease activity is defined as a DAS28 score >=2.6 and <3.2 at any time during the first 24 weeks of each treatment course.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||participants|||Number
124582|NCT00603525|Secondary|Time to Retreatment, by Ofatumumab Treatment Course|Time to retreatment is defined as the time in days between infusion A of each treatment course and infusion A of the following treatment course. For participants randomized to ofatumumab in the Double-blind Period, Treatment Course 1 refers to the course of ofatumumab received in the Double-blind Period. The minimum period allowed per protocol before retreatment was 24 weeks (end of Double-blind Period). For participants randomized to placebo in the Double-blind Period, Treatment Course 1 refers to the first course of ofatumumab received in the Open-label Period. The minimum period allowed per protocol before retreatment during the Open-label Period was 16 weeks.|From Baseline up to Week 144|AT Population. Only those participants contributing values at the indicated time point were analyzed.||Days||Standard Deviation|Mean
124583|NCT00603525|Secondary|Minimum Change From Baseline DAS28-CRP Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using CRP. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
124592|NCT00603525|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Questionnaire Score at Week 24|"The FACIT-F score has a valid range of values from 0 to 52, with a higher score indicating a lower burden of fatigue. The subset determining fatigue contains 13 questions. Responses to each question were scored from 0, indicating Not at all fatigued, to 4, indicating Very much fatigued."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124750|NCT00602836|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|time from registration to death (up to 5 years)||||||
124584|NCT00603525|Secondary|Minimum Change From Baseline DAS28-ESR Score, During the DB and OL Periods, by Ofatumumab Treatment Course|The level of rheumatoid arthritis disease activity based on the DAS28 score is defined as low if DAS28 <=3.2, moderate if 3.2< DAS28 <=5.1, or high if DAS28 > 5.1. A DAS28 <2.6 corresponds to clinical remission. The values summarized are the minimum change from baseline DAS28 score (i.e. greatest change in disease activity during the treatment course) achieved by each participant within the first 24 weeks of each treatment course, assessed by using ESR. Baseline score was determined at the start of each treatment course. For change from baseline, participants had to have both a baseline DAS28 value for the treatment course (i.e., the latest value on or before the date of infusion A of the treatment course, providing it was done within a 14 day window prior to the date of infusion A) and a DAS28 value during the treatment course (i.e., during first 24 weeks of each treatment course). Change from baseline was calculated as the value during the treatment course minus the baseline value.|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population. Only those participants contributing values at the indicated time point were analyzed.||scores on a scale||Standard Deviation|Mean
124585|NCT00603525|Secondary|Minimum DAS28-CRP Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course, assessed using C-reactive Protein (CRP: used to monitor acute inflammatory phases of rheumatoid arthritis).|First 24 weeks of each treatment course (assessed up to Week 144)|AT Population||scores on a scale||Standard Deviation|Mean
124586|NCT00603525|Secondary|Minimum DAS28-ESR Score During the DB and OL Periods, by Ofatumumab Treatment Course|The DAS28 is a clinical index of rheumatoid arthritis disease activity that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of disease activity can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. The values summarized are the minimum DAS28 score (i.e. lowest level of disease activity) achieved by each participant within the first 24 weeks of each treatment course (TC), assessed using erythrocyte sedimentation rate (ESR; rate at which red blood cells sediment in 1 hour).|First 24 weeks of each treatment course (assessed up to Week 144)|As Treated (AT) Population: all participants who received at least one infusion of ofatumumab in the DB and/or OL Period||Scores on a scale||Standard Deviation|Mean
124587|NCT00603525|Secondary|Change From Baseline in Levels of IgA, IgG and IgM at Week 12 and Week 24|The following immunoglobulins were assessed: IgA, IgG and IgM. Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression.|Baseline, Week 12, and Week 24|Safety Population: identical to the ITT population except that participants were analyzed according to their actual treatment when this differed from their randomized treatment. Only those participants contributing values at baseline and the relevant visit were analzyed.||grams per Liter (g/L)||Full Range|Median
124588|NCT00603525|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Week 24|Detection of human anti-human antibodies (HAHAs) against ofatumumab was to be performed by Electrochemiluminescent (ECL) Meso-Scale Discovery (MSD) immunoassay. Positive samples from the binding antibody test were also tested in a neutralizing antibody assay.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124589|NCT00603525|Secondary|Biomarker Levels for Anti-CCP, RF-IgA, RF-IgG, and RF-IgM at Baseline and Week 4|The following biomarkers were assessed: Anti-Cyclic Citrullinated Peptide 3 antibody (Anti-CCP), Rheumatoid factor IgA (RF-IgA), RF IgG (RF-IgG), and RF IgM (RF-IgM). Measurements of RF were used to characterize participants' disease activity and immune status. Anti-CCP was used to characterize the disease type and the immune status of the participants. Assessments for which results were below the lower limit of quantification (LLQ) were reported using a value of LLQ/2. Assessments for which results were above the upper limit of quantification (ULQ) were reported using a value of ULQ.|Baseline and Week 4|ITT Population. Only those participants contributing values at the relevant visit were analyzed.||Units/Liter||Full Range|Median
124590|NCT00603525|Secondary|Change From Baseline in the SF-36v2 Norm-based Scores for Mental Component Summary and Mental Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124591|NCT00603525|Secondary|Change From Baseline in the Short-Form 36 (SF-36v2) Norm-based Scores for Physical Component Summary and Physical Items at Week 24|The SF-36v2 is a standardized questionnaire used to measure overall subjective health status by measuring 8 health-related parameters (each scored from 0 [poorer health] to 100 [better health]): body pain, general mental health (MH), perception of general health, physical functioning, role limitations (RL) caused by mental condition, RL caused by a physical condition, social functioning, and vitality. It yields an 8-scale profile of functional health and well-being scores, as well as psychometrically based physical and MH summary measures and a preference-based health utility index.|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124593|NCT00603525|Secondary|Change From Baseline in the Physician-assessed Global Disease Score Using VAS at Week 24|"The physician used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Physicians were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in the physician-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124594|NCT00603525|Secondary|Change From Baseline in Participant-assessed Global Disease Score Using VAS at Week 24|"The participant used a horizontal VAS of 100 mm for overall assessment of disease. The scale ranged from 0 (very well) to 100 (very poor). Participants were instructed to draw a vertical line through the horizontal line to indicate the state of the arthritis. The distance from the very well end to the vertical line drawn by the participant was the global disease assessment score. Change from baseline in participant-assessed global disease was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124595|NCT00603525|Secondary|Change From Baseline in the Participant-assessed Pain Score Using Visual Analogue Scale (VAS) at Week 24|"A horizontal VAS of 100 mm was used to report the participant’s level of joint pain. The scale ranged from 0 (no pain) to 100 (unbearable pain). Participants were instructed to draw a vertical line through the horizontal line to indicate how much joint pain they had. The distance from the no pain end to the vertical line drawn by the participant was the joint pain score. Change from baseline was calculated as the Week 24 value minus the baseline value."|Baseline and Week 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124596|NCT00603525|Secondary|Change From Baseline in ESR at Week 24|ESR is measured by a blood test that shows the rate at which red blood cells sediment in a period of 1 hour. Blood samples for the determination of ESR were taken at pre-specified visits and were measured immediately at the trial site. Change from baseline in ESR was calculated as the Week 24 value minus the baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||millimeters per hour (mm/hr)||Full Range|Median
124597|NCT00603525|Secondary|Change From Baseline in CRP at Week 24|Blood samples for the determination of CRP were taken at pre-specified visits and were sent to the central laboratory for analysis. Change from baseline in CRP was calculated as the Week 24 value minus the baseline value. CRP is an acute-phase protein whose plasma concentration increases in response to inflammation. CRP is a useful marker of inflammation.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||milligrams per liter (mg/L)||Full Range|Median
124598|NCT00603525|Secondary|Change From Baseline in Swollen Joint Count at Week 24|Change from baseline in swollen joint count was calculated as the Week 24 count minus the baseline count. A total of 66 joints were assessed. Joints were classified as either swollen or not swollen by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||swollen joints||Full Range|Median
124599|NCT00603525|Secondary|Change From Baseline in Tender Joint Count at Week 24|Change from baseline in tender joint count was calculated as the Week 24 count minus the baseline count. A total of 68 joints were assessed. Joints were classified as either tender or not tender by an independent assessor, who had documented experience in performing joint assessments.|Baseline and Week 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||tender joints||Full Range|Median
124600|NCT00603525|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 4, 8, 12, 16, 20, and 24|The HAQ-DI is a 20-question instrument used to assess the degree of difficulty a participant had in accomplishing tasks in 8 functional areas (FAs): dressing, arising, eating, walking, hygiene, reaching, gripping, and errands/chores. Responses for each FA were scored from 0 (no difficulty) to 3 (inability to perform a task). The total score (range of 0-3) was calculated by adding the 8 individual FA scores, then dividing this sum by the total number of components answered. Responders were defined as participants achieving an improvement from baseline in the HAQ-DI score at Week 24 of >=0.22.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||scores on a scale||Full Range|Median
124601|NCT00603525|Secondary|Median of the Largest Integer n, for Which a Participant Met the ACR Criteria Requiring an Improvement of n% (ACRn) at Weeks 4, 8, 12, 16, 20, and 24|ACRn = the largest integer n for which a participant (par.) met the criteria requiring an improvement of n%. ACRn is a measure characterizing percentage (%) improvement from baseline (IFBL). A par. with an ACRn of X had an improvement of >=X% in tender/swollen joints (TJC/SJC), and an improvement of >=X% in 3 of the 5 parameters (patient [pt] pain assessment, pt global assessment [GA], physician GA, pt self-assessed disability, acute phase reactant). ACRn = min(TJC % IFBL, SJC % IFBL, composite measure % IFBL). Composite measure % IFBL is the 3rd highest value of % IFBL for the 5 parameters.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. This trial was terminated prematurely due to the Sponsor's decision to not pursue clinical development of the IV formulation of ofatumumab in an autoimmune indication; thus, no participants were analyzed for this endpoint.|||||
124602|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
124603|NCT00603525|Secondary|Number of Participants With the Indicated European League Against Rheumatism (EULAR) Response at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 <=3.2 to >5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=3.2 to <=5.1); non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
124604|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using ESR as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
124605|NCT00603525|Secondary|Mean DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using Erythrocyte Sedimentation Rate (ESR) as the Acute Phase Reactant (ARP)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
124606|NCT00603525|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 16, 20, and 24 Using CRP as the Acute Phase Reactant|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints, the APR, and general health (patient global assessment). The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation. Change from baseline in DAS28 is calculated as the Week 4, 8, 12, 16, 20, and 24 values minus the baseline value.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at baseline and the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
124607|NCT00603525|Secondary|Mean Disease Activity Score Based on 28 Joints (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 Using C-reactive Protein (CRP) as the Acute Phase Reactant (APR)|The DAS28 is a clinical index of rheumatoid arthritis disease activity (DA) that combines information from swollen and tender joints (jts.), the APR, and general health (patient global assessment). The following jts. were assessed on both sides of the body: shoulder, elbow, wrist, metacarpophalangeal (5 per side), proximal interphalangeal (5 per side), and knee. The level of DA can be interpreted as low (DAS28<=3.2), moderate (3.2<DAS28<=5.1), or high (DAS28>5.1); total score, 0-9.4. A DAS28 <2.6 corresponds to remission. APRs are a class of proteins that are useful markers for inflammation.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants contributing values at the relevant visit were analyzed.||scores on a scale||Standard Deviation|Mean
124608|NCT00603525|Secondary|Number of Participants With a 70% Improvement From Baseline in Their ACR Score (ACR70) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR70 if he experienced >=70% improvement from baseline in TJC and SJC and a >=70% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
124609|NCT00603525|Secondary|Number of Participants With a 50% Improvement From Baseline in Their ACR Score (ACR50) at Weeks 4, 8, 12, 16, 20, and 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR50 if he experienced >=50% improvement from baseline in TJC and SJC and a >=50% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population||participants|||Number
124610|NCT00603525|Secondary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Weeks 4, 8, 12, 16, and 20|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Weeks 4, 8, 12, 16, and 20|ITT Population||participants|||Number
124611|NCT00603525|Primary|Number of Participants With a 20% Improvement From Baseline in Their American College of Rheumatology (ACR) Score (ACR20) at Week 24|The ACR score was based on improvement from baseline in tender (TJC) and swollen joint counts (SJC). A participant had achieved ACR20 if he experienced >=20% improvement from baseline in TJC and SJC and a >=20% improvement from baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, participant self-assessed disability, and C-reactive protein.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants who were exposed to investigational product irrespective of their compliance to the planned course of treatment. Participants were analyzed according to their randomized treatment.||participants|||Number
124751|NCT00602836|Secondary|Number of Participants With a Response (CR, nPR, PR)|Response criteria described in above outcomes|During treatment (up to 5 years)||||||
124612|NCT00603512|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124613|NCT00603512|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124614|NCT00603512|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124615|NCT00603512|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124616|NCT00603512|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124617|NCT00603512|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (=<) 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124618|NCT00603512|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.|Baseline up to Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||units on a scale*weeks||Standard Deviation|Mean
124619|NCT00603512|Secondary|Numeric Index of American College of Rheumatology Response (ACR-n)|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||units on a scale||Standard Deviation|Mean
124620|NCT00603512|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
125655|NCT00593606|Primary|Change in Albumin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||g/l||Standard Deviation|Mean
124621|NCT00603512|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
124622|NCT00603512|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124623|NCT00603512|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
124624|NCT00603512|Secondary|Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
124625|NCT00603512|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
124626|NCT00603512|Secondary|Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
124627|NCT00603512|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
124628|NCT00603512|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
124629|NCT00603512|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 = no pain and 100 = most severe pain.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
124630|NCT00603512|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
124631|NCT00603512|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
124632|NCT00603512|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
125656|NCT00593606|Primary|Change in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Giga/l||Standard Deviation|Mean
124633|NCT00603512|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
124634|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in tender or swollen joint counts and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
124635|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender or swollen joint counts and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/EOT|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
124636|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender or swollen joint counts and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8, 12/End of Treatment (EOT)|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
124637|NCT00603512|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.||Percentage of Participants|||Number
124638|NCT00603512|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using Last observation carried forward (LOCF) method.||Percentage of Participants|||Number
124639|NCT00603473|Secondary|Percent Change in Seizure Frequency (PCH)|PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T−B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.||Percent Change||Full Range|Median
124640|NCT00603473|Secondary|Responder Rate|Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.||Percentage of Subjects||95% Confidence Interval|Mean
124641|NCT00603473|Primary|Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures|The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T−B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.|12 weeks|Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods.||ratio||95% Confidence Interval|Mean
124642|NCT00603447|Primary|Number of Participants With Dose-limiting Toxicities|"Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic~≥ Grade 2 neuropathy with pain~≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide)~≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy~≥ Grade 4 fatigue persisting > 7 days~Treatment delay for toxicity > 21 days~Hematologic~Grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) > 7 days~Febrile neutropenia (ANC < 1,000/mm³ with fever ≥ 38.3ºC)~Grade 4 thrombocytopenia (platelets < 25,000/mm³) for > 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding~Treatment delay for toxicity > 21 days.~The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort."|Cycle 1, 28 days|Safety population for the dose escalation portion of the study||participants|||Number
125657|NCT00593606|Primary|Change in Red Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Tera/l||Standard Deviation|Mean
124643|NCT00603447|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.~Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy."|From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.|Safety population consisting of all treated participants||participants|||Number
124644|NCT00603408|Secondary|Provide Samples for the Development of the FNA Assay||At time of IVAD placement and at time of surgery|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.|||||
124645|NCT00603408|Secondary|Develop Animal Models of Triple Negative Breast Cancers||5 years|Collecting tissue from the optional mastectomy was optional and was not collected on any of the patients.|||||
124646|NCT00603408|Secondary|Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response||5 years|Collecting bone marrow samples were optional and at the time of surgery only 2 patients participated and at the time of port removal submission none of the patients participated.|||||
124647|NCT00603408|Secondary|Number of Participants With Medical Toxicities|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.|30 days post surgery (week 17-18)|||participants|||Number
124648|NCT00603408|Secondary|Number of Participants With Surgical Complications||30 days post surgery (week 17-18)|||participants|||Number
124649|NCT00603408|Secondary|Overall Survival Rate (OS)|OS = Time from registration until death from any cause|Until study was terminated (23.5 months)|||percentage of participants|||Number
124650|NCT00603408|Secondary|Time to Disease Progression|Time to disease progression: time from registration until objective tumor progression; does not include deaths|Until study was terminated (23.5 months)|At the time of study termination, no participants had experienced disease progression.|||||
124651|NCT00603408|Primary|Overall Response|"Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level~Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started,~Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions."|At the time of surgery (week 13)|||participants|||Number
124652|NCT00603382|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
124653|NCT00603382|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
124654|NCT00603382|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.||Nanomoles per 24 hours (nmol/24 hours)||Full Range|Median
124655|NCT00603382|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||scores on a scale||Standard Deviation|Mean
124656|NCT00603382|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
124667|NCT00603382|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.|From Baseline up to Week 8/Early Withdrawal|ITT Population||participants|||Number
124752|NCT00602836|Secondary|Number of Participants Who Convert From a CR With MRD or nPR, PR, or Stable Disease With Residual Disease After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide||12 months||||||
124657|NCT00603382|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||participants|||Number
124658|NCT00603382|Secondary|Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8|Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
124659|NCT00603382|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
124660|NCT00603382|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (g/L)||Standard Deviation|Mean
124661|NCT00603382|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||International units per liter (IU/L)||Standard Deviation|Mean
124662|NCT00603382|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
124663|NCT00603382|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
124664|NCT00603382|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Grams per liter (G/L)||Standard Deviation|Mean
124665|NCT00603382|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Proportion of 1||Standard Deviation|Mean
124666|NCT00603382|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage||Standard Deviation|Mean
124668|NCT00603382|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
124669|NCT00603382|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||participants|||Number
124670|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
124671|NCT00603382|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24 Hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
124672|NCT00603382|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at th end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124673|NCT00603382|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124674|NCT00603382|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1(the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.||Liters||Standard Error|Least Squares Mean
124682|NCT00603304|Secondary|Prostate Specific Antigen (PSA) Level|The mean difference in the PSA level from baseline to 72 weeks in the modified intention to treat analysis. The PSA level was measured in nanograms/milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||ng/mL||95% Confidence Interval|Mean
124675|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL) scale consists of three self administered questions. Two of the questions are scored on a scale of 0 – 3, with zero being none, one being only a little, two being some, and three being a lot. The third question is scored on a scale of 0 -6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed (equally satisfied and dissatisfied), four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 12, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124676|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) urinary symptom scale consists of two self administered questions. The questions are scored on a scale from 0 – 5, with zero being not at all, one being less than 1 time in 5, two being less than half the time, three being about half the time, four being more than half the time, and five being almost always. The lowest possible score is 0 and the highest possible score is 10, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124677|NCT00603304|Secondary|NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale|The mean difference in the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale is a four item self administered questionnaire. Three of the four items are scored on a scale from 0 – 1, with zero being no and one being yes. The fourth item is scored on a scale from 0 – 10, with zero being no pain and ten being pain as bad as you can imagine. The lowest possible score is 0 and the highest possible score is 21, which represents the highest level of pain.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124678|NCT00603304|Secondary|Jenkins Sleep Scale Score|The mean difference in the Jenkins Sleep Dysfunction score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. Jenkins Sleep Dysfunction score is used to assess sleep dysfunction. The four item self administered questionnaire is scored on a scale from 0 to 5, with zero being not at all, one being 1 -3 days, two being 4 – 7 days, three being 8 – 14 days, four being 15 – 21 days, and five being 22 – 31 days. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124679|NCT00603304|Secondary|International Continence Society Male Incontinence Symptom (ICSmale IS) Score|The mean difference in the ICSmaleIS score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The six item self administered questionnaire is scored on a scale from 0 to 4, with zero being never, one being occasionally, two being sometimes, three being most of the time, and four being all of the time. The lowest possible is 0 and the highest possible score is 24, which represents the the highest level of dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124680|NCT00603304|Secondary|Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.|The mean difference in the MSHQ-EjD from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The MSHQ-EjD scale is used for the assessment ejaculatory dysfunction (EjD). The MSHQ-EjD consists of four self administered questions. Three of the items are scored on a scale from 0 to 5, with zero being all the time, one being most of the time, two being some of the time, three being a little of the time, four being none of the time, and five being no sexual activity. The fourth item is scored on a scale of 1 – 5, with one being not at all bothered, two being a little bit bothered, three being moderately bothered, four being very bothered, and five being extremely bothered. The lowest possible score is 0 and the highest possible score is 20, which represents the highest level of dysfunction.|Baseline to 72 weeks.|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124681|NCT00603304|Secondary|International Index of Erectile Function (IIEF)Scale Score.|The mean difference in the IIEF score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IIEF is a multidimensional scale for assessment of erectile dysfunction. The six item self administered questionnaire is scored on a scale from 0 to 5, with zero being no sexual activity, one being never or almost never, two being a few times (much less than half the time), three being sometimes (much less than half the time), four being most times (much more than half the time), and five being always or almost always. The lowest possible score is 0 and the highest possible score is 30, which represents less dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124683|NCT00603304|Secondary|Post-void Residual|The mean difference in the participants' post-void residual from baseline to 72 weeks in the modified intention to treat analysis. The post-void residual was measured in milliliters. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The analysis population was determined by the number of participants that were randomized and included in the modified intention to treat analyses.||mL||95% Confidence Interval|Mean
124684|NCT00603304|Secondary|Peak Uroflow|The mean difference in the participants' peak uroflow from baseline to 72 weeks in the modified intention to treat analysis. The peak uroflow was measured in milliliters/seconds. The higher units indicated greater dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||mL/sec||95% Confidence Interval|Mean
124685|NCT00603304|Secondary|American Urological Association(AUA) Nocturia Item|The mean difference in the nocturia item of the AUA Symptom Score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The nocturia item is a self administered question from the AUA Symptom Score Index that assesses the number of times a participant typically gets up to urinate from the time he goes to bed at night until the time he gets up in the morning. The question is scored on a scale of zero to five, with zero being none, one being one time, two being two times, three being three times, four being four times, and five being five or more times. The lowest possible score is 0 and the highest possible score is 5, which would represent the highest level dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124686|NCT00603304|Secondary|International Prostate Symptom Score Quality of Life (IPSS QOL) Score|The mean difference in the IPSS Quality-of-Life Question from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The IPSS Quality-of-Life Question is an additional question to the AUA Symptom Score. The self administered question is scored on a scale from 0 to 6, with zero being delighted, one being pleased, two being mostly satisfied, three being mixed-about equally satisfied and dissatisfied, four being mostly dissatisfied, five being unhappy, and six being terrible. The lowest possible score is 0 and the highest possible score is 6, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124687|NCT00603304|Secondary|Benign Prostate Hyperplasia (BPH) Impact Index Score|The mean difference in the BPH Impact Index score from baseline to 72 weeks in participants that were included in the modified intention to treat analysis. The BPH Index Score is a self administered 4 item index. Three questions are scored on a scale from 0 to 3, with zero being none, one being only a little, two being some, and three being a lot. One question is scored on a scale from 0 to 4, with zero being none of the time, one being a little of the time, two being some of the time, three being most of the time, and four being all of the time. The lowest possible score is 0 and the highest possible score is 13, which would represent the greatest dysfunction.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124688|NCT00603304|Secondary|Participants Global Assessments of Improvement and Satisfaction at End of Study.|Participants' global assessments of improvement and satisfaction at the end of the study. Likert scales were transformed to a 0 - 100 scale. The lowest possible score is 0 and the highest possible score is 100, which would reflect better outcomes.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124689|NCT00603304|Primary|Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.|The primary outcome was the mean difference in the AUA Symptom Score between baseline and 72 weeks between the saw palmetto and placebo groups. The AUA Symptom Score index is a seven item questionnaire assessing the frequency of lower urinary tract symptoms (LUTS). The questions are scored on a scale of zero to five, with zero being never, one to four being one to four accordingly, and five equaling five or more times. A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort.|Baseline to 72 weeks|The primary analysis was a modified intention to treat analysis including all eligible participants who took at least one dose of study drug and had a least one follow-up AUA Symptom Score measurement.||units on a scale||95% Confidence Interval|Mean
124690|NCT00603291|Secondary|Percent Change in Body Weight From Baseline to Week 52|The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
124691|NCT00603291|Primary|Co-primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more after 52 weeks.~Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF||percentage of participants|||Number
124692|NCT00603278|Secondary|Change From Baseline in Heart Rate at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Beats per minute||Standard Deviation|Mean
124693|NCT00603278|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8|Change from Baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
124694|NCT00603278|Secondary|24-hour Urinary Cortisol Excretion at Baseline and Week 8|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.|Baseline and Week 8|Urine Cortisol (UC) Population: all participants whose urine samples did not have confounding factors that could affect the interpretation of results.||Nanomole per 24 hours (nmol/24hr)||Full Range|Median
124824|NCT00601523|Secondary|UPDRS II Total Score: Change From OL Baseline|UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS II at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
124695|NCT00603278|Secondary|Urine pH at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||scores on a scale||Standard Deviation|Mean
124696|NCT00603278|Secondary|Urine Specific Gravity at Baseline and Week 8/Early Withdrawal|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Urine specific gravity at Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||ratio||Standard Deviation|Mean
124697|NCT00603278|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
124698|NCT00603278|Secondary|Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8|Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
124699|NCT00603278|Secondary|Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8|Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
124700|NCT00603278|Secondary|Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8|Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Grams per liter (G/L)||Standard Deviation|Mean
124701|NCT00603278|Secondary|Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8|Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||International units per liter (IU/L)||Standard Deviation|Mean
124702|NCT00603278|Secondary|Red Blood Cells (RBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
124703|NCT00603278|Secondary|Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8|Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
124704|NCT00603278|Secondary|Hemoglobin at Baseline and Week 8|Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Grams per liter (G/L)||Standard Deviation|Mean
124705|NCT00603278|Secondary|Hematocrit at Baseline and Week 8|Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Proportion of 1||Standard Deviation|Mean
124726|NCT00603239|Secondary|Change in Beta-cell Function|Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||ratio||Standard Error|Geometric Mean
124706|NCT00603278|Secondary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).|Baseline and Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage||Standard Deviation|Mean
124707|NCT00603278|Secondary|Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis|A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.|From Baseline up to Week 8/Early Withdrawal|ITT Population||Participants|||Number
124708|NCT00603278|Secondary|Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||Participants|||Number
124709|NCT00603278|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of study medication up to Week 8/Early Withdrawal|ITT Population||Participants|||Number
124710|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
124711|NCT00603278|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
124712|NCT00603278|Secondary|Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124713|NCT00603278|Secondary|Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.|From Baseline up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124723|NCT00603239|Secondary|Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score|IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = “never true” to 5 = “always true.”|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||units on a scale||Standard Error|Least Squares Mean
124724|NCT00603239|Secondary|Number of Subjects Who Experienced an Episode of Minor Hypoglycemia|Overall number of subjects who experienced an episode of minor hypoglycemia.|26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||Participants|||Number
124727|NCT00603239|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint (26 weeks)|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||cm||Standard Deviation|Mean
124714|NCT00603278|Primary|Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.|Baseline and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement (scheduled and unscheduled visits) was used to impute missing measurements.||Liters||Standard Error|Least Squares Mean
124715|NCT00603265|Secondary|Change From Baseline in NPRS After Walking 50 Feet in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken after the participant walked 50 feet in the clinic. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable post-walk NPRS data.||units on a scale||Standard Error|Least Squares Mean
124716|NCT00603265|Secondary|Change From Baseline in NPRS at Rest in the Clinic|The mean of the daily average scores were calculated from the NPRS pain assessments obtained 1 time per week over a 4-week period. NPRS assessments were taken while the participant was at rest. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. LS means were calculated using ANCOVA with treatment group as a main factor and baseline NPRS score as a covariate. Change from baseline = NPRS at baseline - NPRS at Weeks 1, 2, 3, and 4.|Baseline, Week 1, Week 2, Week 3, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable at-rest NPRS data.||units on a scale||Standard Error|Least Squares Mean
124717|NCT00603265|Secondary|Change From Baseline in the Evening Assessment of the 24-hour Overall Mean Pain Intensity Score|At each of the evening pain assessments, participants assessed their overall pain intensity over the preceding 24 hours using NPRS. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained at Baseline and Week 4. Change from baseline = NPRS at baseline - NPRS at Week 4.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable 24-hour NPRS data.||units on a scale||Standard Deviation|Mean
124718|NCT00603265|Secondary|Change in Sleep Interference Scale (SIS) From Baseline|"Sleep Interference was assessed on an 11-point Numeric Rating Scale where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2, and 3 because a participant could have had multiple visits during Month 1, 2, and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview. LS means were calculated using ANCOVA with treatment group as a main factor and baseline SIS score as a covariate. Change from baseline = SIS score at baseline - SIS score at Week 4."|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable SIS data||units on a scale||Standard Error|Least Squares Mean
124719|NCT00603265|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a participant-rated instrument that measures the change in the participant’s overall status for the previous 2 weeks based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The number of participants in each category is presented.|Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable PGIC data.||participants|||Number
124720|NCT00603265|Secondary|Percentage of Responders|A responder was defined as a participant who showed a reduction in average pain (as measured by NPRS) of at least 30% from baseline to Week 4. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The percentage of participants who qualified as responders is presented per treatment arm.|Baseline, Week 4|All participants who received at least 1 dose of study medication, completed the 4-week treatment period, and had evaluable NPRS data.||percentage of participants|||Number
124721|NCT00603265|Primary|Change From Baseline in Mean Numeric Pain Rating Scale (NPRS) Score|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline.|Baseline, Week 4|All participants who received at least 1 dose of study medication and had evaluable NPRS data. Baseline-observation-carried-forward (BOCF) was used to impute missing postbaseline values for participants who were discontinued from the study early.||units on a scale||Standard Error|Least Squares Mean
124722|NCT00603239|Secondary|Change in Euroqol – 5 Domain Quality of Life (EQ-5D) Score|EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.|baseline and 26 weeks|Based on primary efficacy sample size calculations. Analyses performed on ITT patient population.||units on a scale||Standard Error|Least Squares Mean
124732|NCT00603239|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)|baseline and 26 weeks|The number of participants was determined based on sample size calculations using parameter estimates from prior study H8O-MC-GWAP (NCT00099320), with change from baseline HbA1c as the primary efficacy measure. Primary analysis is reported for intent to treat population (ITT), last observation carried forward (LOCF).||Percentage||Standard Error|Least Squares Mean
124733|NCT00603187|Secondary|LH Blood Serum Concentration|Blood for measurement of serum leutenizing hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days|||iu/L||Standard Deviation|Mean
124734|NCT00603187|Secondary|FSH Blood Serum Concentration|Blood for measurement of serum follicle stimulating hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days|||iu/L||Standard Deviation|Mean
124735|NCT00603187|Primary|Testosterone Blood Serum Concentration|Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.|7 days|||ng/dl||Standard Deviation|Mean
124736|NCT00603044|Secondary|Adjusted Volume of the Removed Adenoids|To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||mL/kg x100||Standard Error|Mean
124737|NCT00603044|Primary|Amount of TGF Secreted by Adenoid Cells After PHA Stimulation|Amount of TGF secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||picogram per milliliter (pg/mL)||Full Range|Median
124738|NCT00603044|Primary|Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation|Amount of IL-10 secreted by adenoid cells after PHA stimulation|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||picogram per milliliter (pg/mL)||Full Range|Median
124739|NCT00603044|Primary|IL-10 Staining Intensity|IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||IOD/100 micrometer squared||Standard Error|Mean
124740|NCT00603044|Primary|Number of CD4 Pos/FOXP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||cells per High power field (HPF)||Full Range|Median
124741|NCT00603044|Primary|Number of CD25 Pos/FoxP3 Positive Cells|The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25|following adenoidectomy (2 weeks)|Some subjects were excluded due to technical issues.||cells per High power field (HPF)||Full Range|Median
124742|NCT00603018|Primary|Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors|We used PET and [11C]WAY to assess 5-HT1A binding potential (BP) = [11C]WAY 100635 BP = Distribution Volume (DV)ROI−DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3|Baseline and 8 weeks|||mL/cm^3||Standard Deviation|Mean
124743|NCT00602927|Secondary|Effect of Varenicline Treatment on Task Performance (N-back Correct Response Time)|We examined the difference in correct reaction time on the N-back task between varenicline and placebo treatment. Models included terms for the main effect of treatment period (varenicline vs. placebo), memory load (0-back, 1-back, 2-back, 3-back) and covariates. We tested for interactions between nicotine dependence severity and treatment.|Day 13|Participants who completed both study phases were included in the analysis. Other participants (n=3) were excluded due to measurement artifact.||Milliseconds||Standard Deviation|Mean
124744|NCT00602927|Primary|Percent Change BOLD Signal|We calculated the percent BOLD signal change while performing the N-back task between the varenicline vs. placebo session. We subtracted BOLD signal observed during the 0-back condition from the BOLD signal observed during the 3-back condition (3back minus 0-back)We controlled for relevant co-variates such as sex, nicotine dependence level and education.|Day 13|Participants who completed both study phases were included in the analyses (n=25). Additional participants (n=3) were excluded due to measurement artifact.||BOLD Signal Change (3-back minus 0-back)||Standard Error|Mean
124745|NCT00602836|Secondary|Number of Participants With FISH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. FISH status describe in baseline characteristics section.|During treatment (up to 5 years)||||||
124746|NCT00602836|Secondary|Number of Participants With ZAP-70 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. ZAP-70 status describe in baseline characteristics section.|During treatment (up to 5 years)||||||
124747|NCT00602836|Secondary|Number of Participants With CD38 Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. CD38 status described in baseline characteristics section.|During treatment (up to 5 years)||||||
124748|NCT00602836|Secondary|Number of Participants With IgVH Testing at Baseline Who Also Had a Clinical Response (CR, nPR, or PR).|Response categories described in above outcome measures. IgVH mutation status describe in baseline characteristics section.|During treatment (up to 5 years)||||||
124749|NCT00602836|Secondary|Time to Disease Progression (TTP)|Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median TTP with 95% CI was estimated using the Kaplan Meier method.|time from registration to progression (up to 5 years)||||||
124753|NCT00602836|Secondary|Number of Participants Who Convert From a CR With Minimal Residual Disease (MRD) Positive Status After PCR to a CR With MRD-negative Status After 6 Courses of Consolidation With Lenalidomide|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells to determine if there was any MRD.|12 months||||||
124754|NCT00602836|Secondary|Number of Participants Who Convert From a Nodular Partial Response (nPR), Partial Response (PR), or Stable Disease (SD) After Pentostatin, Cyclophosphamide, and Rituximab (PCR) to a Complete Response (CR) After 6 Courses of Consolidation With Lenalidomide|"According to the NCIWG criteria, response is defined as follows:~nPR: Meets all criteria for CR, as described above, except the presence of residual clonal nodules in the bone marrow PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions SD: participant who does not meet any of the criteria described above"|12 months||||||
124755|NCT00602836|Primary|Number of Participants With Complete Response (CR)|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG), requires all of the following for a period of at least 2 months:~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|12 months|||participants|||Number
124756|NCT00602771|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.|6 months|||participants|||Number
124757|NCT00602641|Secondary|Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12|A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome).|Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.|Patients who completed both baseline and cycle 12 QOL assessments.||units on a scale||Standard Deviation|Mean
124758|NCT00602641|Secondary|Very Good Partial Response (VGPR) Rate|Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria.|Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.|Intention-to-treat (ITT) population||proportion of participants||95% Confidence Interval|Number
124759|NCT00602641|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treatment (ITT) population||months||95% Confidence Interval|Median
124760|NCT00602641|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the earlier of progression or death of any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.|Intention-to-treat (ITT) population||months||95% Confidence Interval|Median
124761|NCT00602472|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction greater than 0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124762|NCT00602472|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124763|NCT00602472|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124764|NCT00602472|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124765|NCT00602472|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124766|NCT00602472|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124767|NCT00602472|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124768|NCT00602472|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124769|NCT00602472|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124770|NCT00602472|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
124771|NCT00602472|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|"The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment.~HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule."||Percent||Standard Error|Mean
124772|NCT00602472|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
124773|NCT00602472|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
124774|NCT00602446|Secondary|Reduction in Liver Iron Concentration After Study Drug|Efficacy as measured by reduction in liver iron concentration (LIC) after 6 months of the study drug compared to baseline (LIC at baseline minus LIC at 6 months). This shows the mean reduction for the 3 subjects treated in this study.|6 Months|All patients included in count.||milligrams/gram||Standard Deviation|Mean
124775|NCT00602446|Primary|Number of Patients Not Completing Treatment|Number of patients who discontinued deferasirox during 6 month daily treatment due to drug related toxicity|6 Months|Note: 1 patient had a transient decrease in hemoglobin that required discontinuation of treatment for 2 weeks; subsequently restarted at same dose and completed therapy.||Participants|||Number
124776|NCT00602420|Primary|Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.|Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days.|From baseline through day 5|||(Pain Scale Score)*Days||95% Confidence Interval|Mean
124777|NCT00602355|Secondary|Hamilton Anxiety Rating Scale (HARS)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
124778|NCT00602355|Secondary|Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)|Measure total ranges from 1 to 5, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
124779|NCT00602355|Secondary|Global Illness Severity Based on Clinical Global Impression (CGI) Scale|Measure total ranges from 1 to 7, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
124780|NCT00602355|Secondary|Depression Illness Severity Based on Beck Depression Inventory (BDI)|Measure total ranges from 0 to 56, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
124781|NCT00602355|Primary|Hamilton Depression Rating Scale (HAM-D)|Measure total ranges from 0 to 50, with lower scores indicating better outcomes.|Measured at baseline; post-treatment; and Months 3 and 6 of follow-up|||units on a scale||Standard Deviation|Mean
124782|NCT00602290|Secondary|Quality of Life Assessment||Measured at Baseline and Week 16||||||
124783|NCT00602290|Primary|Hamilton Depression Rating Scale (HDRS) Maintained Scores at Week 16|The Hamilton Depression Rating Scale (HDRS) is a 24-item depression scale and the total score is summed with a minimum score=0 and maximum score=76. There are no subscales and the higher values represent a worse outcome. Outcomes are measured and defined as follows: 1) Response will be defined as HDRS scores of 10 or less; 2) Sustained response will be defined as maintained response at week 16; 4) Remission will be defined as HDRS scores of 6 or less.|Maintained response measured at Week 16|||units on a scale||Standard Deviation|Mean
124784|NCT00602043|Secondary|Correlation of FES Uptake With ER Assays|Graphical and numerical studies of bivariate relationships will be examined, as well as factors (i.e., tumor size, tumor location, patient age) to explain concurrence, lack of concurrence, and sources of measurement error for measurements of ER function.|Up to 6 months||||||
124785|NCT00602043|Secondary|Time to Progression|FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of time to progression. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.|Up to 6 months||||||
124786|NCT00602043|Secondary|Clinical Benefit|FES SUV prior to endocrine treatment (dichotomized and as a continuous predictor) will also be tested as predictor of CB. Analysis will be conducted using (respectively) logistic regression and Cox proportional hazards regression. This will include univariate analysis of FES and other predictive measures (ER/PgR expression, serum sex steroid levels), followed by an exploratory multivariate analysis combining FES SUV with other measures showing predictive capability univariate analysis.|Up to 6 months||||||
124787|NCT00602043|Primary|Best Overall Response|"Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease [per response evaluation criteria in solid tumors (RECIST, version 1.1)], size-based response criteria were used to assess response.~For patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD).~The initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months)."|Up to 6 months|||patients with progressive disease|||Number
124788|NCT00601965|Primary|Penn State Worry Questionnaire|The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.|56 weeks|||units on a scale||Standard Deviation|Mean
124789|NCT00601965|Primary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score >= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of >=5, for a total Hamilton >=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).|56 weeks|||participants|||Number
124790|NCT00601952|Primary|Post-Traumatic Stress Disorder Checklist-Military Version (PCL-M)|The PCL-M is a 17-item questionnaire that assesses the severity of PTSD symptoms using a 5-point Likert scale ranging from “not at all” to “extremely,” with a minimum score of 17 and a maximum score of 85 (Weathers, Litz, Herman, Huska, & Keane, 1993). Participants are asked to rate to what extent they experienced PTSD symptoms over the previous month due to prior combat experiences. The military version of the PCL (PCL-M) refers specifically to a traumatic military related event (Weathers, Litz, Huska, & Keane, 1994). Research suggests that the PCL-M has good test-retest reliability (r = .70) and internal consistency (alpha = .97; Weathers et al., 1993).|Pre, Post, Followup|||units on a scale||Standard Deviation|Mean
124791|NCT00601926|Secondary|Safety of Bevacizumab in This Population of Patients|Grade 3 or higher toxicities according to CTCAE version 3.0|Up to 2 years|||toxicities|||Number
124792|NCT00601926|Primary|Response Rate to Bevacizumab in This Population.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 years|Includes patients with Complete response, partial response or stable disease||patients|||Number
124793|NCT00601926|Primary|Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.|Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|||months||Full Range|Median
124794|NCT00601900|Secondary|Treatment Related Toxicity|Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Tabulated by type, grade, and arm.|Up to 5 years||||||
124795|NCT00601900|Secondary|Time-to-treatment Failure|From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure|Up to 5 years||||||
124796|NCT00601900|Secondary|Site of Progression||Up to 5 years||||||
124797|NCT00601900|Secondary|Probability of Surviving Until 36 Months||At 36 months||||||
124798|NCT00601900|Secondary|Duration of Tumor Response|Defined by RECIST criteria.|From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years||||||
124799|NCT00601900|Secondary|Overall Survival (OS)|OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|Assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||months||95% Confidence Interval|Median
124800|NCT00601900|Secondary|Objective Response Rate|Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Assessed up to 5 years|Per protocol, the analysis of this endpoint was restricted to patients that elected letrozole as endocrine therapy and began treatment with measureable disease. A total of 213 patients (Arm A:106; Arm B:107) had measureable disease. Of the 213, 197 (Arm A:98, Arm B:99) patients were assessed for response during treatment.||percentage of participants|||Number
124801|NCT00601900|Secondary|6 Month Progression-Free Survival Rate|The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study.|At 6 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||percentage of participants||95% Confidence Interval|Number
124802|NCT00601900|Secondary|12 Month Progression Free Survival Rate|The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study.|At 12 months|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||percentage of participants||95% Confidence Interval|Number
124803|NCT00601900|Primary|Progression-free Survival|The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions.|From randomization until disease progression or death whichever occurs first, assessed up to 5 years|Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.||months||95% Confidence Interval|Median
124804|NCT00601835|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Canadian-Manufactured or US-Manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Chills, Diarrhea, Fever (temperature), Headache, Malaise, Muscle weakness, Nausea, Pain in joints, Rash, and Vomiting.|0-14 days post-vaccination|Solicited safety parameters were in all enrolled and vaccinated participants ≥ 60 years of age and one third of participants 11 to 59 years of age. A subset of the intend-to-treat population.||Participants|||Number
124805|NCT00601835|Secondary|Post-vaccination Geometric Mean Titer (GMT) to Tetanus and Diphtheria in Participants ≥ 60 Years Vaccinated With Canadian-manufactured or US-manufactured Tetanus and Diphtheria Toxoids Adsorbed Vaccine.||28 Days post-vaccination|Geometric mean titers were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population||Titers||95% Confidence Interval|Geometric Mean
124806|NCT00601835|Primary|Percentage of Participants ≥ 60 Years of Age With Antibody Levels ≥ 0.10 IU/mL to Tetanus and Diphtheria.|Seroprotection and booster responses for both tetanus and diphtheria were considered to be an antibody level of ≥ 0.10 IU/mL 28 days post-vaccination with either the Canadian-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine or the US-manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine in participants ≥ 60 years of age.|28 Days post-vaccination|Seroprotection and Booster Responses to Tetanus and Diphtheria were determined in subjects ≥ 60 years of age in the per-protocol immunogenicity population.||Percentage of participants|||Number
124807|NCT00601796|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena.|3 years|All participants||participants|||Number
124808|NCT00601796|Secondary|Median Overall Survival (OS)|Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.|3 years|All participants||months||95% Confidence Interval|Median
124809|NCT00601796|Secondary|Median Time to Progression (TTP)|"Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier."|3 years|All participants||months||95% Confidence Interval|Median
125071|NCT00598442|Secondary|Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
124810|NCT00601796|Primary|Number of Evaluable Participants With Tumor Response|Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.|3 years|14 participants with evaluable PBMCs||participants|||Number
124811|NCT00601731|Secondary|GMTs in Subjects Within Each Site and in Age-Matched Control Subjects|The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.|At 40 and 60 months of age|The analysis was done on MITT population||Titers||95% Confidence Interval|Geometric Mean
124812|NCT00601731|Secondary|Percentage of Subjects With hSBA ≥1:4|Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|The analysis was done on MITT population||Percentages of subjects||95% Confidence Interval|Number
124813|NCT00601731|Primary|Percentage of Subjects With hSBA ≥1:8|Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.|At 40 and 60 months of age|Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.||Percentages of subjects||95% Confidence Interval|Number
124814|NCT00601523|Secondary|Patient Rating of Convenience of Treatment Dosing|Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)||participants|||Number
124815|NCT00601523|Secondary|Patient Preference Regarding Treatment Dosing|Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment)||participants|||Number
124816|NCT00601523|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)||Percentage of participants|||Number
124817|NCT00601523|Secondary|Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients|Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment|Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80 (patients from 248.524) or week 72 (patients from 248.636)||Patients|||Number
124818|NCT00601523|Secondary|L-Dopa Dose: Change From OL Baseline|Change from open-label baseline in Levodopa dose|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and with L-Dopa at OL baseline and at week 80 (patients from 248.524) or week 72 (patients from 248.636)||Patients|||Number
124819|NCT00601523|Secondary|Number of Patients Introducing L-Dopa Medication in OL Trial|Number of patients requiring Levodopa supplementation during the study|80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)|Patients from FAS||Patients|||Number
124820|NCT00601523|Secondary|Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline|PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for PFS-16 at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
124821|NCT00601523|Secondary|Response in Patient Global Impression of Improvement (PGI-I)|"Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for PGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)||Patients|||Number
124822|NCT00601523|Secondary|Response in Clinical Global Impression of Improvement (CGI-I)|"Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders"|OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)|Patients from FAS and who had values for for CGI-I at week 32 (patients from 248.524) or at week 24 (patients from 248.636)||Patients|||Number
124823|NCT00601523|Secondary|UPDRS III Total Score: Change From OL Baseline|UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
124825|NCT00601523|Secondary|UPDRS I Total Score: Change From OL Baseline|UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood|OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from FAS and who had values for UPDRS I at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
124826|NCT00601523|Secondary|Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)|A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Patients|||Number
124827|NCT00601523|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)|Patients from Full Analysis Set (FAS included all patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment) and who had values for UPDRS II+III at week 80 (patients from 248.524) or at week 72 (patients from 248.636)||Units of scale||Standard Deviation|Mean
124828|NCT00601458|Secondary|Time to First Request of PCA Hydromorphone|Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery|||Hours||Inter-Quartile Range|Median
124829|NCT00601458|Primary|Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery|Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg.|First 24 hours following surgery|||milligrams||Inter-Quartile Range|Geometric Mean
124830|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
124831|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy by Gender.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
124832|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
124833|NCT00601419|Primary|Proportion of Participants Achieving Clinical Efficacy.|Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.|6 month|The efficacy analysis population basically consists of the evaluable participants in whom clinical responses were assessed comprehensively based on the time profile of variables including IGF-I, blood pressures, pulse rate, lipid metabolism, body composition, QOL, and degree of participant's satisfaction.||participants|||Number
124834|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.|To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
124835|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
124836|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.|To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
124837|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
124838|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
124839|NCT00601419|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||events|||Number
124840|NCT00601419|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|6 month|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.||participants|||Number
124841|NCT00601367|Primary|Frequency of Adverse Events||28 weeks|||participants with any adverse event|||Number
124842|NCT00601354|Other Pre-specified|Weeks of Adherence to Orlistat||Number of adherent weeks over 1 year study|Intent to treat||week of adherence to orlistat||Standard Deviation|Mean
124843|NCT00601354|Secondary|Binge Frequency|frequency of objective binge days over prior 28 days|3 months: Measured from pre to post treatment|Intent to treat||% change objective binge days||Standard Deviation|Mean
124844|NCT00601354|Primary|Weight Loss|Change in weight in lbs from per to post treatment|3 months: Measured from pre to post treatment|Used intent-to-treat analysis||lbs||Standard Deviation|Mean
124845|NCT00601250|Secondary|2 Hour Post−Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24|This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Least Squares Mean
124846|NCT00601250|Secondary|Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline PPG and previous anti-diabetic medication.|Baseline and week 24|Meal Tolerance Test (MTT) set (treated and randomised patients with adequate MTT results available at the beginning and end of the randomised treatment period)||mg/dL||Standard Error|Mean
124847|NCT00601250|Secondary|Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline >= 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124848|NCT00601250|Secondary|Percentage of Patients With HbA1c<6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124849|NCT00601250|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 6.5%. Only patients with baseline HbA1c >= 6.5%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124850|NCT00601250|Secondary|Percentage of Patients With HbA1c < 7.0% at Week 24|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%.|Baseline and week 24|This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124851|NCT00601250|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24.|The percentage of patients with an HbA1c value below 7.0% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c >= 7.0%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).||percentage of patients|||Number
124852|NCT00601250|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124853|NCT00601250|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124854|NCT00601250|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124855|NCT00601250|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
124856|NCT00601250|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
124857|NCT00601250|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
124858|NCT00601250|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
124859|NCT00601250|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
124860|NCT00601146|Primary|To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.|In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded|3 years|Enrolled patients who underwent low-dose CCT screening- number of lung cancer diagnosed||participants|||Number
124861|NCT00601107|Secondary|Percentage of Participants With Static Physician’s Global Assessment (PGA) Score of Clear or Almost Clear at Week 12, 24 or Early Termination|Static PGA of psoriasis is scored on a 5-point scale (0 = clear to 4 = severe), reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. Clear (erythema: no, scale: no, induration: no thickness); Almost Clear (erythema: light pink, scale: fine scale, induration: barely palpable); Mild (erythema: light red, scale: coarse scale on most lesions, induration: slight but visible elevation, indistinct edges); Moderate (erythema: red, scale: coarse adherent scale predominates, induration: moderate elevation with edges); and Severe (erythema: dark red to purple, scale: thickened adherent scale, induration: marked thickness distinct and pronounced edges). Percentage of participants with static PGA score of clear or almost clear are reported.|Week 12 or Early Termination, Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.||percentage of participants|||Number
124862|NCT00601107|Secondary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 24 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 24 or Early Termination|FAS included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.||percentage of participants|||Number
124863|NCT00601107|Primary|Percentage of Participants With at Least 50 Percent (%) Reduction in Psoriasis Area Severity Index (PASI) Score at Week 12 or Early Termination|PASI score: range: 0 (no disease) to 72 (maximal disease). Body was divided into head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent area of skin involved (A) was estimated: 1 (<10%) to 6 (90% - 100%), and severity was estimated by clinical signs: (erythema [E], induration [I], and desquamation [D]) on a scale: 0=no symptoms, 4=very marked. PASI score= 0.1 (E[h] + I[h] + D[h]) A[h] + 0.2 (E[u] + I[u] + D[u]) A[u] + 0.3 (E[t] + I[t] + D[t]) A[t] + 0.4 (E[l] + l[I] + D[l]) A[l].|Week 12 or Early Termination|The Full Analysis Set (FAS) included all safety set-evaluable participants with at least one post-baseline PASI assessment after the date of first dose in the treatment period.||percentage of participants|||Number
124864|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Tmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, time to reach maximum plasma concentration (Tmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||(h)||Inter-Quartile Range|Median
124865|NCT00600938|Secondary|Extension Study: Change in Serum Ferritin From Baseline by Month|Serum ferritin values was summarized by descriptive statistics. Absolute value and the absolute change from baseline in serum ferritin by month was provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase||ug/L||Standard Deviation|Mean
124866|NCT00600938|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|Results of liver iron content (LIC) measurements by MRI was summarized by descriptive statistics. The absolute value and the absolute change from baseline in LIC at Months 6, 12, 18 and 24 were provided by treatment group.|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase||mg Fe/g dw||Standard Deviation|Mean
124867|NCT00600938|Secondary|Extension Study: The Cardiac Iron Concentration From T2* Values|Cardiac iron concentration (derived from T2* values) at baseline, Months 6, 12, 18 and 24 were summarized by descriptive statistics. The absolute change from baseline at Months 6, 12, 18 and 24 were also summarized by treatment group. Lliver iron concentration is expressed in units (mg of iron / g of liver tissue dry weight (dw)|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase||mg Fe/g dw||Standard Deviation|Mean
124868|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI)|Cardiac function endpoints (LVMI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites||gram/m^2||Standard Deviation|Mean
124869|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|Cardiac function endpoint (LVEDVI ) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites||mL/m^2||Standard Deviation|Mean
124870|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|Cardiac function endpoints (LVESVI) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.||mL/m^2||Standard Deviation|Mean
124871|NCT00600938|Secondary|Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF)|Cardiac function endpoints (LVEF) obtained by CMR at baseline, Months 6, 12, 18 and 24 were summarized by means of descriptive statistics. These analyses were conducted for the measured values as well as for the absolute changes from baseline|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase. Cardiac function parameters over time - excluding patients in Egypt sites.||Percent||Standard Deviation|Mean
124872|NCT00600938|Secondary|Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment|The measured T2* values, the ratio (post-baseline / baseline T2*) at Month 6, 12, 18 and 24 was summarized for FAS population along with two-sided 95% CIs. The geometric means of the ratio was presented for all treatment groups|Months 6, 12, 18 and 24|Full Analysis Set (FAS): consisted of all patients enrolled in the extension. Patients were analyzed according to the treatment they were assigned to in the beginning of the extension phase.||Ratio||95% Confidence Interval|Geometric Mean
124873|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. For trough concentration assessments, a 2-mL blood sample was to be taken on arrival at the study site, i.e. prior to the patient receiving the daily deferasirox dose (pre-dose blood sample). A second 2-mL blood sample was to be taken 2 hours later (post-dose sample). At all other visits (Visits 3 - 14), a pre-dose sample was to be taken. For PK profile assessments, 3 blood samples were taken after 1, 2, and 4 hours post-dose in addition to the 2-mL pre-dose|Month 1 and month 2 (pre-dose, 1,2 and 4 hours post-dose)|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||(umol/L)||Standard Deviation|Mean
124874|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Cmax)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, maximum plasma concentration (Cmax)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||umol/L||Standard Deviation|Mean
124875|NCT00600938|Secondary|Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau)|The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, area under the plasma concentration-time curve for a dosing interval (AUCtau)|12 Month|Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose).||(h.ng/mL)||Standard Deviation|Mean
124876|NCT00600938|Secondary|Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period.|Number of patients with adverse events, serious adverse events and death|12 Month|Safety Set (SS) consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. Treatment received is defined as first study drug administered||Participants|||Number
124877|NCT00600938|Secondary|Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine|The number of patients withdrawn from the study due to LVEF <50%, T2* <6 ms or significant decreases in T2* ≥ 33% from baseline was provided per treatment group.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Participants|||Number
124878|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI)|An absolute change from baseline in LVMI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||gram/m^2||Standard Deviation|Mean
124879|NCT00600938|Secondary|Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)|An absolute change from baseline in LVEDVI after 6, and 12 months treatment with deferasirox and DFO was summarized|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Percent||Standard Deviation|Mean
124880|NCT00600938|Secondary|Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI)|An absolute change from baseline in LVESVI after 6 and 12 months treatment with deferasirox and DFO was summarized. Changes in cardiovascular magnetic resonance (CMR) measured left ventricular end systolic after 6 and 12 months treatment. Left ventricular (LV) end-systolic volume indexed to body surface area (ESVI) is a simple yet powerful echocardiographic marker of LV remodeling that can be measured easily. Left ventricular (LV) end-systolic volume (ESV) has been shown to be an important determinant of survival after myocardial infarction (MI)|6 Month, 12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Milliliter||Standard Deviation|Mean
124881|NCT00600938|Secondary|Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment|Summary statistics of T2* ratio Month 6/baseline|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Ratio||95% Confidence Interval|Geometric Mean
124882|NCT00600938|Secondary|Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 6 months treatment with deferasirox and DFO was summarized|6 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations||Percent||Standard Deviation|Mean
124883|NCT00600938|Secondary|Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)|An absolute change from baseline in LVEF after 12 months treatment with deferasirox and compared to.DFO was tested using an analysis of covariance model including baseline left ventricular ejection fraction (LVEF) as a covariate.|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.||Percent||Standard Error|Least Squares Mean
124884|NCT00600938|Primary|Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment|Non- inferiority in efficacy of deferasirox compared to deferoxamine (DFO) in treating cardiac iron overload as measured by T2*. A non-inferiority margin of 0.9 (90%) was applied. Due to limitations in performing heart biopsies, T2* (T2 star), a Magnetic Resonance (MR) relaxation parameter expressed in milliseconds, as is an important tool to noninvasively quantify cardiac iron concentration. Studies have shown that myocardial T2* evaluations may predict cardiac events, e.g., impaired (<56%) left ventricular ejection fraction (LVEF) is prevalent among patients with low T2*: found in 62% of patients with T2*<8 ms; 20% with T2* of 8-12 ms; and in 5% with T2* >12 ms (Tanner 2006)|12 Month|Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations.||Millisecond||95% Confidence Interval|Geometric Mean
124885|NCT00600886|Secondary|Effect of Pasireotide LAR and Octreotide LAR as Long Term Treatment and After Cross Over on (i)GH<2.5 ug/L and (ii) Normalized IGF-1||12 Months||03/2017||||
124886|NCT00600886|Secondary|Effect of Pasireotide LAR vs. Octreotide LAR as Long Term Treatment and After Cross-over on the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and Nomalization of IGF-1 to Within Normal Limits (Age and Sex Related)||12 Months||03/2017||||
124887|NCT00600886|Secondary|Effect of Pasireotide LAR vs. Octreotide LAR on Health Related Quality of Life||12 Months||03/2017||||
124888|NCT00600886|Secondary|Effect of Pasireotide LAR vs. Octreotide LAR on Tumor Volume||12 Months||03/2017||||
124889|NCT00600886|Secondary|Effect of Pasireotide LAR vs. Octreotide LAR on Reduction of GH to <2.5 ug/L Alone||12 Months||03/2017||||
124890|NCT00600886|Primary|Compare the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and the Normalization of IGF-1 Between the Two Teatments Groups|"Post Surgery were participants who underwent surgery and their data were collected post surgery. Remaining participant, who were not suitable for or refused surgery, were considered De novo."|12 months|Full Analalsys set All patients who were randomized into the study.||Percentage of Participants||95% Confidence Interval|Number
124891|NCT00600821|Other Pre-specified|Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype|UGT1A1 an enzyme of the glucuronidation pathway that transforms small lipophilic molecules, such as steroids, bilirubin, hormones, and drugs, into water-soluble, excretable metabolites.|Baseline (Day 1 of Cycle 1)|Data was reported in listings but not summarized due to statistical constraints.|||||
124892|NCT00600821|Secondary|Plasma Concentration of Soluble Proteins|Plasma concentrations of soluble proteins (soluble- stem-cell factor receptor (sKIT) vascular endothelial growth factor [VEGF], and vascular endothelial growth factor receptor-2 [VEGFR2], VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.||Picogram/mL (pg/mL)||Standard Deviation|Mean
124893|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.||Flourescent Intensity Unit (FIU)||Standard Deviation|Mean
124894|NCT00600821|Secondary|Circulating Endothelial Cells (CEC) in Blood: Total CEC|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.|Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1|ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. ‘n’: participants evaluated at specific time point for each group respectively. ‘N’ (Number of participants analyzed) signifies participants evaluable for the measure.||Cells/milliliter (cells/mL)||Standard Deviation|Mean
124895|NCT00600821|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood|RNA expression profiles of genes which were associated with tumor growth, angiogenesis and metastases were collected and correlated with efficacy.|Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1|Data was not generated but sample was collected for banking and moved to a separate exploratory research database for future research.|||||
124896|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||Units on a scale||Standard Deviation|Mean
124897|NCT00600821|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhoea, and financial difficulties). Most questions used 4- point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years)|ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.||Units on a scale||Standard Deviation|Mean
124898|NCT00600821|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1||||||
124899|NCT00600821|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||Months||95% Confidence Interval|Median
125133|NCT00597519|Primary|Overall Response|To obtain a preliminary estimate of efficacy of double unit UCBT as measured by overall response.|1 year|||participants|||Number
124900|NCT00600821|Secondary|Percentage of Participants With Objective Response (OR)|OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all lesions (target and/or non target) and no appearance of new lesions. PR: at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, without progression of non target lesions and no appearance of new lesions.|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
124901|NCT00600821|Secondary|Overall Survival (OS)|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the first randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years)|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
124902|NCT00600821|Primary|Progression Free Survival (PFS)|"Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
124903|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 231 evaluable men, 111 were missing individual AE “Sexual Dysfunction” data”.~Risperidone: Out of 231 evaluable men, 106 were missing individual AE “Sexual Dysfunction” data”."||Participants|||Number
124904|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.|Month 12|"Safety population at Month 12 is presented. Quetiapine XR: Out of 160 evaluable women, 73 were missing individual AE “Hyperprolactinaemia” data.~Risperidone: Out of 171 evaluable women, 74 were missing individual AE “Hyperprolactinaemia” data”."||Participants|||Number
124905|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic|Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
124906|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population|The normal range for men is 0 to 14, and for women is 0 to 24.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||ng/mL||Standard Deviation|Mean
124907|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
124908|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population|Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Events|||Number
124909|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
124910|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
124911|NCT00600756|Secondary|The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population|Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).|12 months|The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).||Participants|||Number
124912|NCT00600756|Secondary|The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
124913|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population|Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
124914|NCT00600756|Secondary|Number of Participants Using Antidepressants at Month 12 in the ITT Population|"The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup N06-Antidepressants."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
124915|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population||12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Days||Standard Deviation|Mean
124916|NCT00600756|Secondary|Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population|Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.|Month 12|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
124917|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population|All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
124918|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population|"Workers and students are defined from the modified vocational status index excluding subjects Retired or Unemployed, whether or not expected to work."|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Days||Standard Deviation|Mean
124919|NCT00600756|Secondary|To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State|Stable State was defined as having the same status in occupational and residential status as at Baseline.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants with stable state|||Number
125357|NCT00594854|Secondary|Number of Participants With Duodenal Ulcers Confirmed by Endoscopy|Number of participants with duodenal ulcers confirmed by endoscopy following administration of PN 400 VIMOVO)or Arthrotec in a high risk population|6 months|||participants||95% Confidence Interval|Number
124920|NCT00600756|Secondary|Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.|The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
124921|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population|Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.|12 months|The Reported population is participants who showed relapse over time, from baseline to Month 12.||Participants|||Number
124922|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
124923|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score|For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0).|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Deviation|Mean
124924|NCT00600756|Secondary|The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).|For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
124925|NCT00600756|Secondary|The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population|Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12|12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Participants|||Number
124926|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
124927|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
124928|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
124963|NCT00599924|Secondary|Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).|Cycle 3 (Day 1), Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.|||||
124929|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
124930|NCT00600756|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.|The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.|Baseline and 12 months|The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.||Scores on a scale||Standard Error|Least Squares Mean
124931|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).||Scores on a scale||Standard Error|Least Squares Mean
124932|NCT00600756|Secondary|Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population|The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.|Baseline and Month 12|For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).||Scores on a scale||Standard Error|Least Squares Mean
124933|NCT00600756|Primary|Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score|The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)|6 months|For Per Protocol at Month 6 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (169) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (160).||Participants|||Number
124934|NCT00600704|Primary|Mean Number of Packed Red Cells Units Transfused During Hospital Stay||20 months|Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass||packed red cells units|Participants|95% Confidence Interval|Mean
124935|NCT00600613|Primary|"Number of Participants Eligible for Cone Beam Tumor Localization"|Assess the feasibility of using a new imaging technique called “cone beam imaging” to localize a liver tumor immediately prior to external beam radiotherapy.|Up to 2 hours|||participants|||Number
124936|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
124937|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: Screening and 24 Hours After Dosing on Day 1|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), Screening and >=24 hours after the first dose (Visit 2) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|Screening (Visit 1) and 24 hours after dosing on Day 1 (Visit 2)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
124964|NCT00599924|Secondary|Cmin of Free Platinum, Total Platinum, and 5-FU||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Cmin was not calculated for Free Platinum, Total Platinum, and 5-FU.|||||
124938|NCT00600171|Secondary|Difference in Post Salbutamol/Albuterol FEV1 (FEV1 30 Minutes After a Single Dose of 400 µg Salbutamol/Albuterol) Between the Following Time Points: 24 Hours After Dosing on Day 1 and Day 28|Assessment at Visit 2/2a was made prior to the evening dose of study medication on Day 2. Participants were administered a single 400 µg dose of salbutamol/albuterol, and FEV1 was measured 30 minutes after this administration. The highest of three technically acceptable measurements was recorded. These assessments were performed as follows: between 5 PM and 10 PM, >=6 hours after the last use of salbutamol/albuterol, >=6 hours after the last caffeine consumption, >=2 hours after exercise (or strenuous activity), >=24 hours after the first dose (Visit 2) or last dose (Visit 5) of study medication. Analysis was performed using ANCOVA with covariates of Baseline (pre-salbutamol measurement at Screening), country, sex, age, stratum, and treatment. Analysis is of the differences in absolute FEV1 measurements taken post-salbutamol/albuterol.|24 hours after dosing on Day 1 (Visit 2) and on Day 28 (Visit 5)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
124939|NCT00600171|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. Change from Baseline is calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
124940|NCT00600171|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Averaged Over the 28-day Treatment Period|Participants who were symptom free for 24 hours were assessed. Change from Baseline was calculated as the value at Day 28 minus the value at Baseline (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
124941|NCT00600171|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily AM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124942|NCT00600171|Secondary|Mean Change From Baseline in Trough (Pre-dose and Pre-bronchodilator) Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 28-day Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily PM over the 28-day treatment period (at Day 28) minus the Baseline value (defined as the last 7 days prior to randomization of the participants). Analysis was performed using ANCOVA with covariates of Baseline, country, sex, age, stratum, and treatment.|Baseline and Days 1-28|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters per minute||Standard Error|Least Squares Mean
124943|NCT00600171|Secondary|Change From Baseline in Weighted Mean 24-hour Serial FEV1 at Day 1 and Day 28|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Change from Baseline in weighted mean for 24-hour serial FEV1 on Days 1 and Day 28 was assessed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline; Day 1 and Day 28 (mean post-dose FEV1 after 15, 30, and 60 minutes and 2, 3, 4, 6, 12, 16, 20, 22, 23, and 24 hours)|ITT Population. Only those participants available at the indicated time points were analyzed.||Liters||Standard Error|Least Squares Mean
124944|NCT00600171|Secondary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 Per Stratum (LOCF)|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline in trough FEV1 at the end of the treatment period (23 hours and 24 hours after dosing on Day 28) was analyzed for each stratum (Lower stratum: FEV1 percent predicted, >=40% to <=65%; Upper stratum: FEV1 percent predicted, >=65% to <=90%). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, treatment, and treatment by stratum interaction.|Baseline and Day 28|ITT Population. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used. Only those participants with available data (using LOCF) at the indicated time point were analyzed.||Liters||Standard Error|Least Squares Mean
124945|NCT00600171|Primary|Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF])|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 at the end of the 28-day treatment period, with the trough FEV1 defined as the mean of the 23 hour and 24 hour post-dose assessments on Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) using LOCF with covariates of Baseline (pre-dose on Day 1), country, sex, age, stratum, and treatment.|Baseline and Day 28|ITT Population: all participants who were randomized to treatment and received at least one dose of study medication. The LOCF method was used to impute missing data. When the endpoint was missing, the last valid non-missing on-treatment, post-Baseline trough assessment was used instead. Only measurements from scheduled visits were used.||Liters||Standard Error|Least Squares Mean
124946|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||units on a scale||Standard Deviation|Mean
124947|NCT00600119|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely).The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) worries and concerns (11 items), 2) physical discomfort (4 items), 3) psychosocial discomfort (8 items), and 4) satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||units on a scale||Standard Deviation|Mean
124948|NCT00600119|Secondary|Change From Baseline in SBMs/Week Across the 28-day Double-blind Period|Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period.|Days 1 through 28|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||Number of SBMs/week||Standard Deviation|Mean
124949|NCT00600119|Primary|Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1|Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.|Days 1 through 7|The MITT analysis population consisted of all randomized patients who received at least 1 dose of double-blind study treatment, had a baseline value and Visit 6 evaluable data (where Visit 6 was the Week 1 visit during the double-blind study treatment period).||Number of SBMs/week||Standard Deviation|Mean
124950|NCT00600080|Primary|Subjective Lens Comfort|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||units on a scale||Standard Deviation|Least Squares Mean
124951|NCT00600080|Secondary|Optimum Lens Fit|Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria [between -1 and +1 on a -2 to +2 grading scale.|Baseline, 1-week, 2-week|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.||participants|||Number
124952|NCT00600080|Secondary|Subject-reported Overall Product Performance|"Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= Extremely poor or Cannot use lenses and 100= Excellent or Highly impressed with these lenses overall). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used."|2-week|Analyzed subjects were those who were enrolled and randomized to a study arm.||units on a scale||Standard Error|Least Squares Mean
124953|NCT00600080|Primary|Visual Acuity|Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.|2-week|Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.||logMAR scale||Standard Deviation|Mean
124954|NCT00600067|Secondary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
124955|NCT00600067|Primary|HbA1c Change From Baseline Week 0 to Week 56||Baseline to 56 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
124956|NCT00600015|Secondary|Overall Survival (OS)||18 months|||Months||95% Confidence Interval|Median
124957|NCT00600015|Secondary|6-month PFS||6 months||||||
124958|NCT00600015|Secondary|Duration of Response||18 months||||||
124959|NCT00600015|Secondary|Disease Control Rate (DCR)||18 months||||||
124960|NCT00600015|Primary|Progression Free Survival (PFS)||18 months|||Months||95% Confidence Interval|Median
124961|NCT00600015|Primary|Overall Objective Response Rate (ORR)||18 months|||Percent||95% Confidence Interval|Number
124962|NCT00599924|Secondary|Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI|IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.|Cycle 3 (Day 1) and Cycle 3 (Day 8)|No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.|||||
124965|NCT00599924|Secondary|CL/F of Free Platinum, Total Platinum, and 5-FU|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|CL/F was not calculated for Free Platinum, Total Platinum, and 5-FU.|||||
124966|NCT00599924|Secondary|T1/2 of Free Platinum, Total Platinum, and 5-FU|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|T1/2 was not calculated for Free Platinum, Total Platinum, and 5-FU.|||||
124967|NCT00599924|Secondary|Cmax of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|Cmax of 5-FU was not calculated.|||||
124968|NCT00599924|Secondary|Area Under the Curve (AUC) of 5-FU||pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|AUC for 5-FU was not calculated.|||||
124969|NCT00599924|Secondary|Steady State Clearance (CLss) of 5-FU|CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||L/hr||Standard Deviation|Mean
124970|NCT00599924|Secondary|Steady State Concentration (Css) of Fluorouracil (5-FU)|Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
124971|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
124972|NCT00599924|Secondary|Tmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
124973|NCT00599924|Secondary|Cmax of Total Platinum|Oxaliplatin was metabolized to platinum and total platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
124974|NCT00599924|Secondary|T1/2 for Free Platinum|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Standard Deviation|Mean
124975|NCT00599924|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
124976|NCT00599924|Secondary|Tmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
124977|NCT00599924|Secondary|Cmax of Free Platinum|Oxaliplatin was metabolized to platinum and free platinum was measured.|pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
124978|NCT00599924|Secondary|T1/2 of SU-012662 (Sunitinib's Metabolite)|t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for SU-012662 was not calculated due to short observation time.|||||
124979|NCT00599924|Secondary|CL/F of SU-012662 (Sunitinib's Metabolite)|CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|CL/F was not calculated for SU-012662.|||||
124980|NCT00599924|Secondary|AUC24 for SU-012662 (Sunitinib's Metabolite)|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
124981|NCT00599924|Secondary|Cmin of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|||ng/mL||Standard Deviation|Mean
124982|NCT00599924|Secondary|Tmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
124983|NCT00599924|Secondary|Cmax of SU-012662 (Sunitinib's Metabolite)||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
124984|NCT00599924|Secondary|Terminal Phase Half-Life (t1/2) of Sunitinib|t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|T1/2 for sunitinib was not calculated due to short observation time.|||||
124985|NCT00599924|Secondary|Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib|AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng*hr/mL||Standard Deviation|Mean
124986|NCT00599924|Secondary|Clearance (CL/F) of Sunitinib|Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.|pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||L/hr||Standard Deviation|Mean
124987|NCT00599924|Secondary|Minimum Plasma Concentration (Cmin) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
124988|NCT00599924|Secondary|Time to Cmax (Tmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed PK blood sampling for at least one day.||hours||Full Range|Median
124989|NCT00599924|Secondary|Maximum Plasma Concentration (Cmax) of Sunitinib||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|ITT population of subjects who had completed pharmacokinetic (PK) blood sampling for at least one day.||ng/mL||Standard Deviation|Mean
124990|NCT00599924|Secondary|Objective Response (OR)|From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)|ITT||participants|||Number
124991|NCT00599924|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|up to 20 weeks|Intent to treat (ITT) = all subjects enrolled in the study that received at least one dose of study medication. Subjects who did not complete the follow-up period for dose limiting toxicity assessment because of death from progressive disease or other non-treatment related events were replaced.||participants|||Number
124992|NCT00599872|Secondary|Scores on a Scale (The Average Combined Allergy Symptom and Medication Score During the Ragweed Season for Each Subject)|The average combined allergy symptom and medication score during the ragweed season for each subject. This score is computed for each subject by adding their daily relief medication scores (excluding beta-agonist use) and their daily RSS for the entire ragweed season, and then taking the average of the combined scores across days.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
124993|NCT00599872|Secondary|Scores on a Scale (Total Allergy Relief Medication Score During the Ragweed Season) for Each Subject|Total allergy relief medication score during the ragweed season for each subject. This score is computed for each subject by summing their individual medication scores (excluding beta-agonist use) for the entire ragweed season. High scores were indicative of poor symptom relief from the study medication. The associated relief medication scores assigned to medication are 0-if no medication taken; 3 for each one antihistamine tablet taken; 1 for each 2 antihistamine eye drop administrations, 1 for each 2 antihistamine nasal spray administrations and 1 for each puff of beta-agonist. The maximum medication score was dependent on the cumulative rescue medication use. The lower result the more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
124994|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Ragweed Season for Each of the Three Organ) Systems (Ocular, Nasal, Ears);|The average daily RSS during the ragweed season for each of the 3 organ systems (ocular, nasal, ears) were separately analyzed to evaluate these individual components of the RSS. Three separate baseline average daily RSS values were computed for this analysis. The modified ITT population was used for this analysis. The range for scores: 0 to 3 for each of eight symptom or a total of 0 to 24 daily RSS. A lower score was more favorable.|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
124995|NCT00599872|Secondary|Scores on a Scale (Average Daily AM RSS and the Average Daily PM RSS During the Ragweed Season)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS (the sum of the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS)."|Ragweed pollen season 08/01/08 to 10/30/08|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
124996|NCT00599872|Secondary|Scores on a Scale (Average Daily RSS During the Highest Pollen Count Week)|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season.~The highest pollen count week was defined as the 7 contiguous days from the series with the largest average pollen count, and in which the weekly average was computed using at least 4 non-missing daily RSS values (either AM or PM could be present to be considered a valid daily RSS value)."|09/01/2008-09/07/2008|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||scores on a scale||Standard Deviation|Least Squares Mean
125041|NCT00598871|Secondary|Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)|Number of diabetic patients who had undergone epithelial debridement during vitrectomy resulted in complete corneal wound closure of the affected eye at the end of treatment (Day 14)|14 days|Analysis per protocol, ITT (Intent to treat), using LOCF (Last Observation Carried Over)||participants|||Number
124997|NCT00599872|Primary|Scores on a Scale (Average of Daily Rhinoconjunctivitis Symptom Score (RSS) Recorded During the Ragweed Season|"Symptom score defined as sum of scores from eight symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe): ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Average daily RSS ranged from 0-48; A lower score was more favorable.~The average daily RSS was computed for each subject by: (1) summing the 8 individual allergy symptoms recorded in the morning (AM RSS) and the evening (PM RSS); (2) forming the daily RSS by summing the AM RSS and the PM RSS for each day of the ragweed season; (3) averaging the daily RSS for the entire ragweed pollen season."|Ragweed pollen season, 08/01/08 to 10/30/08, approximately 3 months|The modified ITT population: subjects with 12 weeks or more of treatment (based on subject consent date and date of ragweed season for the site)||Scores on a scale||Standard Deviation|Least Squares Mean
124998|NCT00599755|Post-Hoc|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy At a Threshold of a 30% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 30% decrease in SUVmean of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy||Participants|||Number
124999|NCT00599755|Secondary|Change in FGD-PET Uptake From Baseline to Week 6|"Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.~The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass."|Baseline and Week 6|Participants with PET scans at baseline and 6 weeks after starting chemotherapy.||Fold change in SUVmean||90% Confidence Interval|Number
125000|NCT00599755|Secondary|Change in FDG-PET Uptake From Week 3 to Week 6|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Week 3 and Week 6|Participants with PET scans at 3 weeks and 6 weeks after starting chemotherapy||Fold change in SUVmean||90% Confidence Interval|Number
125001|NCT00599755|Secondary|Change in FDG-PET Uptake From Baseline to Week 3|Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Baseline and Week 3|Participants with PET scans at baseline and 3 weeks after starting chemotherapy||Fold Change in SUVmean||90% Confidence Interval|Number
125002|NCT00599755|Secondary|Repeatability of FDG SUVmean at Baseline|Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy|Participants who underwent two baseline PET scans||SUVmean||Standard Deviation|Geometric Mean
125003|NCT00599755|Primary|Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean|Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.|Weeks 3 and 6 following chemotherapy|Participants with evaluable scans classified as non-metabolic responders relative to baseline at 3 Weeks after starting chemotherapy||Participants|||Number
125004|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Non-Infl Lesion||Standard Error|Least Squares Mean
125005|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
125006|NCT00599521|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to 12 weeks|||% Change in Lesion Count||Standard Deviation|Mean
125007|NCT00599521|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12||Baseline to 12 weeks|||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
125008|NCT00599521|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12|||Percentage of Participants|||Number
125009|NCT00599339|Secondary|Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)|The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.|33 months|For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.||Adverse Events|||Number
125023|NCT00599313|Primary|Median Progression-free Survival (PFS) Time at 1-year.|"PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|12 months|ITT population||weeks||Full Range|Median
125010|NCT00599339|Secondary|Hoehn & Yahr Stage at Visit 7 (Month 33)|"The Hoehn and Yahr staging of Parkinson’s disease in the “on” stage, if applicable, had to be completed by the physician.~Possible staging:~0 No signs of disease~1 Unilateral disease~2 Bilateral disease without impairment of balance~3 Mild to moderate bilateral disease, some postural instability, physically dependent~4 Severe disability, still able to walk or stand unassisted~5 Wheelchair bound or bedridden unless aided"|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||participants|||Number
125011|NCT00599339|Secondary|Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)|"The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.~The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
125012|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson’s disease rating scale (UPDRS) Part IV question 39 asks “What proportion of the waking day is the patient off, on average? Answers range from 0 (None) to 4 (76-100 % of the day)."|33 months|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
125013|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)|The Unified Parkinson’s disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question “How disabling are the dyskinesias ? “ Answers range from 0 (Not disabling) to 4 (Completely disabling).|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
125014|NCT00599339|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)|"The Unified Parkinson’s disease rating scale (UPDRS) question 32 of part IV asks. What Proportion of the waking day are dyskinesias present? Answers range from 0 (None) to 4 (76-100 % of the day)."|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
125015|NCT00599339|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)|The Unified Parkinson’s disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).|From Baseline to Visit 7 (Month 33)|"All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study."||units on a scale||Standard Deviation|Mean
125016|NCT00599326|Secondary|Number of Participants Showing Decrease in Ferritin and Urinary Porphyrin Level|Patients with PCT usually have normal or elevated serum iron and ferritin levels as well as increased iron absorption. Phlebotomy is conducted to analyzes the ferritin levels. Urine collection is performed and samples of the urine are analyzed for porphyrin levels.|6 months|||participants|||Number
125017|NCT00599326|Primary|Number of Participants Showing Reduction or Elimination of Skin Blistering|The present trial was undertaken to determine if oral deferasirox could be useful in the treatment of PCT. Monthly clinic visits with a physical examination was conducted to assess the skin for blisters.|Within 6 months of treatment.|||participants|||Number
125018|NCT00599313|Secondary|Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.|Pain score decreased >=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week’s average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week’s period.|12 months|Patients with pain measurement at baseline.||percentage of participants||95% Confidence Interval|Number
125019|NCT00599313|Secondary|Objective Response Rate (ORR) st|OORR = Complete Response (CR) + Parcial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.RR = Completed response (CR) + Partial response (PR).|12 months|Only patients with baseline measurable lesions.||percentage of participants||95% Confidence Interval|Number
125020|NCT00599313|Secondary|Change of PSA Doubling Time|Difference of PSA doubling time between baseline and end of the treatment.|Baselie and up to 12 months|Patients who had measurements of prior and post doubling time.||months||Full Range|Median
125021|NCT00599313|Secondary|Prostate Specific Antigen (PSA) Response|PSA value declined to 50% when compared to the value at the baseline.|12 months|Evaluable population||percentage of participants||95% Confidence Interval|Number
125022|NCT00599313|Secondary|Overal Survival (OS) Rate at 1-year.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|12 months|ITT population||Probability of Survival at 1-year||95% Confidence Interval|Number
125024|NCT00599248|Secondary|Cartilage Regeneration by Histology and Observation|The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production.|0, 3, 7, 11, 28 (prior to surgery), and day 29 (one day post-surgery) following dosing. Follow-up patient monitoring will be performed at 3, 6, 9, and 12 months following dosing|Intention-to-treat - patients with observable evidence of cartilage regeneratoin||participants|||Number
125025|NCT00599248|Primary|Summary of Adverse Events|The incidence of observations at the site of administration and the incidence adverse events assessed through 28 days after treatment.|Through 28 days post-dosing|Intention-to-treat||Adverse events|||Number
125026|NCT00599196|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.||Score on a scale||Standard Deviation|Mean
125027|NCT00599196|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.||Subjects|||Number
125028|NCT00599196|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|six years|Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.||Subjects|||Number
125029|NCT00599131|Secondary|The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia|To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.|3 years.|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
125030|NCT00599131|Secondary|Overall Survival Time|To determine the overall survival rates compared to the overall survival rates of historical controls.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
125031|NCT00599131|Secondary|The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment.|To evaluate the quality of life (QOL).|24 months|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
125032|NCT00599131|Secondary|The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF.|To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies.|Day 23|The study was discontinued prematurely due to an early stopping rule. No participants were assessed because an insufficient number of patients were recruited.|||||
125033|NCT00599131|Primary|Percentage of Patients Achieving Histologic Complete Response|The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.|3 years|The study was discontinued prematurely due to an early stopping rule. No participants were assessed for the primary outcome because an insufficient number of patients were recruited.|||||
125034|NCT00599053|Primary|Safety of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of serious of adverse event experienced by subjects treated with azithromycin|from day 1 of study drug through 100 days or discharge from hospital, which ever comes first|||number of events||Full Range|Mean
125035|NCT00599053|Primary|Pharmacokinetics of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Pharmacokinetic measures (AUC12) of subjects receiving azithoromycin who had eradication of ureaplasma spp.at either day 100 or discharge day which ever comes first.|100 days or discharge from hospital|Unable to determine PK data due to low enrollment|||||
125036|NCT00599053|Secondary|Respiratory Outcomes as Determined by Subjects Without Respiratory Tract Ureaplasma Spp Infection in Subjects in the Two Treatment Groups|Absence of Ureaplasma spp infection is determined by the total number of days with positive pressure ventilation, (conventional ventilation or nasal continuous positive pressure) and oxygen therapy. The mean number of days was used to compare the two treatment groups.|from baseline to 100 days or discharge from Hospital, which ever comes first|||days||Full Range|Mean
125037|NCT00599053|Primary|Microbiological Efficacy of Azithromycin Treatment for Eradication of Ureaplasma Spp. in Preterm Infants|Number of subjects without ureaplasma spp at 100 days after study entry or at hospital dischargein subjects receiving therapy|100 days or discharge from hospital|Unable to determine efficacy due to low enrollment|||||
125038|NCT00599027|Primary|The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.|To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.|Baseline and 28 days of treatment|||units on a scale||Standard Deviation|Mean
125039|NCT00599014|Secondary|Hospitalization||30 days|||participants|||Number
125040|NCT00599014|Primary|Death, Heart Transplant, Left Ventricular Assist Device Implantation||5 years|||participants|||Number
125042|NCT00598871|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy|Number of participants with Number of Treatment Emergent Adverse Events (TEAEs) in the Target Eye in diabetic patients who had undergone epithelial debridement during vitrectomy and treated with thymosin beta 4|14 days|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||Participants|||Number
125043|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Non-Infl Lesion count||Standard Error|Least Squares Mean
125044|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
125045|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12||Baseline to Week 12|||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
125046|NCT00598832|Secondary|Mean Percent Change in Total Lesion Count From Baseline to Week 12|Percent change in lesion count from baseline to week 12|From Baseline to Week 12|||% Change in Lesion Count||Standard Deviation|Mean
125047|NCT00598832|Primary|Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12|"Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). 0 = clear , 1= almost clear, 2= mild, 3= moderate, 4=severe."|From Baseline to Week 12|||Percentage of Participants|||Number
125048|NCT00598819|Primary|Overheating of Skin Underneath Sensor|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to immediately post-removal|||Participants|||Number
125049|NCT00598819|Secondary|Sensor Attachment Under Stress|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|addition of stress on sensor to removal.|||Participants|||Number
125050|NCT00598819|Secondary|Sensor Fits Well on Subjects Forehead|"How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as yes or no."|placement of sensor to end of study observation|||Participants|||Number
125051|NCT00598819|Primary|Overheating of Skin Underneath Sensor.|"The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt:~• Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study."|placement of sensor to 10 minutes post-removal.|||Participants|||Number
125052|NCT00598819|Primary|Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.|Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator.|attachment of sensor to 24 hours post-removal|The number of participants was determined by protocol specifications.||Participants|||Number
125053|NCT00598702|Primary|Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event|"A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose to 30 days after last dose|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||Subjects|||Number
125054|NCT00598702|Secondary|Physician's Global Assessment of Study Treatment|Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).|End of study or Early Termination|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||participants|||Number
125055|NCT00598702|Primary|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication.|First dose to end of treatment period|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||Subjects|||Number
125056|NCT00598702|Secondary|Subject's (Parent/Guardian) Global Evaluation of Study Treatment|Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).|Day 0 to Day 5, Day 7 or Early Termination from study|All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.||participants|||Number
125057|NCT00598689|Secondary|Tolerability and Alleviation of Post-operative Pain in LASIK Surgery|A comparison of subjective comfort level defined as tolerability and alleviation of post-operative pain experienced as a result of post-operative application of GenTeal drops. Subjective pain level was measured on a 10 point likert scale where 0 = no pain and 10 = worst pain possible. A lower score at Week 1 as compared to Day 1 was considered improved. A same score or higher at week 1 as compared to day 1 was considered no improvement.|Week 1 post surgery|Subjects randomized to either group and completed LASIK surgery.||percentage of subjects|||Number
125058|NCT00598689|Secondary|Post Operative Pain Level|Assess whether preoperative GenTeal Gel alleviates post operative pain in LASIK surgery patients compared to control (no preoperative lubricant) as measured by patient completion of the Universal Pain Assessment Tool (moderate), a ten point scale with 0 being no pain and 10 being the worst pain possible. Data on the level of pain only in the right eye will be collected.|Day 1, End of Week 1|Subjects that completed LASIK surgery.||units on a scale||Standard Deviation|Mean
125059|NCT00598689|Primary|Epithelial Healing After Laser Assisted in Situ Keratomileusis (LASIK) Surgery|Assess whether preoperative GenTeal Gel enhances epithelial healing after LASIK surgery within the first post-operative week, compared to control (no preoperative lubricant). Healing of the area of the cornea covering the radius of the sectioned into clock hours 0 - 12 where 0 hours equals no healing and 12 hours equals complete healing.|Day 1, End of Week 1|Subjects that completed LASIK surgery.||Clock Hours||Standard Deviation|Mean
125060|NCT00598650|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes."|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set||Score on a Scale||Standard Deviation|Mean
125061|NCT00598650|Primary|Change From Baseline in Mini-mental State Examination (MMSE) Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.|Baseline, Week 52, and Week 52 LOCF|Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis.||Score on a Scale||Standard Deviation|Mean
125062|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7.|Study period lookback at Day 7|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Units on a scale||Standard Deviation|Mean
125063|NCT00598559|Primary|Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)|"Serious TEAE is any untoward medical occurrences at any dose of study medication that:~results in death~is life threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose (T0) to within 30 days of the last dose of study medication.|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Participants|||Number
125064|NCT00598559|Primary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up|Safety analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Participants|||Number
125065|NCT00598559|Secondary|Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments|Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge)|End of Day 5 (prior to discharge)|Analyses were conducted using the mITT population, defined as subjects who were randomized to the IV acetaminophen groups and who received at least one dose of IV acetaminophen, and all subjects assigned to the SOC group.||Units on a scale||Standard Deviation|Mean
125066|NCT00598507|Secondary|Occurrence of Attributable Serious Adverse Events (SAEs)|Number of participants with Grade 3 or higher adverse events, attributable to treatment with sagopilone.|Up to 5 years|All participants||participants|||Number
125067|NCT00598507|Secondary|Median Overall Survival (OS)|Median OS: the time (expressed in months or years) when half the patients are expected to be alive.|Up to 5 years|All participants||weeks||95% Confidence Interval|Median
125068|NCT00598507|Secondary|Median Progression Free Survival (PFS)|PFS: the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD)according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants||weeks||95% Confidence Interval|Median
125069|NCT00598507|Primary|Response Rate (RR)|Objective tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 5 years|All participants||participants|||Number
125070|NCT00598442|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods|A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
125072|NCT00598442|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
125073|NCT00598273|Secondary|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods.|A hemoglobin response is defined as hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.|Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
125074|NCT00598273|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
125075|NCT00598273|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.|Baseline and Weeks 25-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
125076|NCT00598078|Primary|Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor|The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left & right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA & EEE sounds, an action evaluation of left & right hands pouring, bringing liquids to mouth, drawing large & small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors).|Hour 1|||Points||90% Confidence Interval|Least Squares Mean
125077|NCT00597909|Secondary|Pharmacokinetic Characteristics of Ammonul® and Its Metabolites||Every 24 hours during treatment period of 96 hours||||||
125078|NCT00597909|Secondary|Effects of Ammonul® on Blood Ammonia Levels, Amino Acids and Carnitine||96 hours of treatment and follow-up||||||
125079|NCT00597909|Secondary|Efficacy, as Assessed by Severity of Hepatic Encephalopathy Using the Glasgow Coma Scale||96 hours of treatment and follow-up||||||
125080|NCT00597909|Secondary|Efficacy, as Assessed by Percentage of Subjects With a 1 or 2 Grade Improvement, Using the West Haven Criteria||participants will be followed for the duration of hospital stay, an expected average of 96 hours||||||
125081|NCT00597909|Secondary|Efficacy, as Assessed by Time Spent in an Improved State by 1 or 2 Grades Using the West Haven Criteria||96 hours of treatment and follow-up||||||
125082|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With 1-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up||||||
125083|NCT00597909|Secondary|Efficacy, as Assessed by Proportion of Assessments With a 2-grade Improvement, Using West Haven Criteria||96 hours of treatment and follow-up||||||
125084|NCT00597909|Secondary|Safety, as Assessed by Reported Adverse Events, Clinical Laboratory Measurements, Changes in Vital Signs, and Changes in 12-lead ECG Results||96 hours of treatment and follow-up||||||
125085|NCT00597909|Primary|Efficacy, as Assessed by Time to Grade 2 or Less in the West Haven Criteria Sustaining for 4 Hours or Longer||Time to Grade 2 or less sustaining for 4 hours or longer|One participant enrolled but did not receive drug or was randomized.|||||
125086|NCT00597896|Primary|Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency|The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||words||Standard Deviation|Mean
125087|NCT00597896|Primary|Change From Baseline to Week 8 in Hopkins Verbal Learning Test|The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||words||Standard Deviation|Mean
125088|NCT00597896|Primary|Change From Baseline to Week 8 in d2 Test of Attention|"The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the d's with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed."|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
125089|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part B|The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe “executive” functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||seconds||Standard Deviation|Mean
125149|NCT00597402|Secondary|12-month Progression-free Survival (PFS)|Percentage of participants surviving twelve months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|12 months|||percentage of participants||95% Confidence Interval|Number
125090|NCT00597896|Primary|Change From Baseline to Week 8 in Trail Making Test Part A|The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe “executive” functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||seconds||Standard Deviation|Mean
125091|NCT00597896|Primary|Change From Baseline to Week 8 in Stroop Color-Word Test|The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with ‘Xs’ printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||words||Standard Deviation|Mean
125092|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test|Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
125093|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)|The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||number of correct numbers recalled||Standard Deviation|Mean
125094|NCT00597896|Secondary|Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint|The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 (“Insight”) which is rated on a 5-point Likert scale. These items yield two subscale scores—one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
125095|NCT00597896|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||units on a scale||Standard Deviation|Mean
125096|NCT00597896|Primary|Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)|The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.|Change from Baseline to Week 8|All randomized participants were assessed per protocol||number of correct numbers recalled||Standard Deviation|Mean
125097|NCT00597753|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
125098|NCT00597753|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
125099|NCT00597753|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline and Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
125100|NCT00597714|Secondary|Graft Failure|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3–5 weeks after transplant to assess donor-cell engraftment. Primary Graft Failure was defined as a neutrophil count below 500/μL or the absence of donor-derived hematopoiesis (<5%donor cells) before relapse, death, or re-transplantation. Secondary Graft Failure was defined as the achievement of primary engraftment and a subsequent decrease in neutrophils to 3 consecutive counts of less than 100/μL or the absence of donor-derived hematopoiesis (<5% donor cells) before relapse, death, or re-transplantation.|180 days|All subjects who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and donor type.||number of participants|||Number
125658|NCT00593606|Primary|Change in Platelet Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Giga/l||Standard Deviation|Mean
125101|NCT00597714|Other Pre-specified|Graft Versus Host Disease|Estimate toxicity including graft-versus-host disease (GVHD) in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Bone marrow aspiration and/or biopsy were performed 3–5 weeks after transplant to assess donor-cell engraftment. Acute or chronic GVHD was diagnosed and graded according to standard criteria. Toxicity was formally graded using the National Cancer Institute Common Toxicity Criteria version 3.0.|180 days|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by occurrence of Graft versus Host Disease (GvHD) and Graft Failure and donor type.||percentage of participants||95% Confidence Interval|Number
125102|NCT00597714|Secondary|Overall Survival|Estimate overall survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. OS was defined as the period of time between the day of transplantation and death. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants surviving 2 years by donor type is reported.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||percentage of participants||95% Confidence Interval|Number
125103|NCT00597714|Secondary|Progression Free Survival|Progression-free survival (PFS) rates after stem cell transplant were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. PFS was defined as the period of time between the day of transplantation and either the day underlying disease progression was documented or death occurred by any cause. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants progression free at 2 years is reported by donor type. Progression = > 25% increase of serum M-protein and/or urine M-protein. Also, an absolute increase in bone marrow plasma cells > 10%, new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions or soft tissue plasmacytomas or development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|2 years|All participants who received transplant. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||percentage of participants||95% Confidence Interval|Number
125104|NCT00597714|Secondary|Immune Recovery|Evaluate immune recovery following this reduced intensity allogeneic immunotherapy. Quantification of CD3+, CD4+, and CD8+ T cells was performed by flow cytometry on fresh peripheral blood at approximately 1 month before transplantation and then 1.5, 3, 6, and 12 months after transplantation. The immune recovery rates of the CD3+, CD4+, and CD8+ T cells in the MRD, MUD, and HAPLO groups were compared by performing an analysis of variance at each time point after transplantation. The median T cell counts at 12 months for each type of cell are reported by donor type.|1 year|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. Analysis by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||T cells/μL||Standard Deviation|Mean
125105|NCT00597714|Primary|Disease Free Survival|Estimate disease free survival rates in participants treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation. Disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates after SCT were estimated using the Kaplan-Meier method. We performed univariate comparisons by using the log-rank test. DFS was defined as the period of time between the day of transplantation and either disease relapse or death due to the disease. The following variables were considered as confounders: recipient age, recipient sex, disease (myeloid or lymphoid), disease risk (standard or high), and donor type (MRD, MUD, or HAPLO donor). The percentage of participants who were disease free at 2 years is reported by donor type.|2 years|All subjects with complete response. Cohort A (n=62) had acute or chronic leukemia (ALL or CLL), lymphoma, or myeloma. Cohort B (n=62) had acute or chronic myeloid leukemia (AML or CML), myelodysplastic disorder or myeloproliferative disorder. DFS was analyzed by type of donor (Matched Unrelated Donor; Matched Related Donor; Haplo-identical).||percentage of participants||95% Confidence Interval|Number
125106|NCT00597701|Primary|Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups|In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.|From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed.|||mg of benzodiazepine per 8 hours||Standard Deviation|Mean
125107|NCT00597584|Secondary|Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)||Weeks 29 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
125108|NCT00597584|Secondary|Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods||Weeks 0 to 36|Full Analysis Population: All randomized participants who received at least one dose of study medication||percentage of participants|||Number
125109|NCT00597584|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.|Baseline to Weeks 29-36|Full Analysis Population: All randomized participants who received at least one dose of study medication||g/dL||Standard Deviation|Mean
125110|NCT00596466|Primary|Number of Participants With Laboratory Test Values of Potential Clinical Importance|Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.|Baseline up to Week 28|Safety analysis set population; Number of participants analyzed (N): participants with at least one observation of any given laboratory test while on study.||Participants|||Number
125111|NCT00596466|Primary|Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Week 28|Safety analysis set population: all participants who received at least 1 dose of pregabalin.||Participants|||Number
125112|NCT00596466|Primary|Seizure Frequency||Baseline up to Week 28|Not analyzed; Per protocol, seizure frequency data for individual participants were collected and reviewed but no statistical inferences were conducted because there was no comparator agent for this study.|||||
125113|NCT00596453|Primary|PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)|"We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test.~We planned to compare the differences between the first two PSA tests and the last two PSA tests in the Placebo vs Cipro groups."|1 month post enrollment|||ng/mL||Standard Deviation|Mean
125114|NCT00596440|Secondary|Show Rate at First Treatment Session||week one|This analysis includes only a subset of participants who had not discontinued the study by week 1.||participants|||Number
125115|NCT00596440|Secondary|Smoking Cessation Rate||week nine|The 129 participants represents a subset of the sample that participated in treatment. This subset of participants includes only those who attended eligibility session and participated in the week 9 follow-up. One oncology relative became ineligible immediately following completion of this counseling session and was excluded.||participants|||Number
125116|NCT00596440|Primary|Accrual Rate (Eligibility Visit)|Show rate to eligibility visit|week zero|||participants|||Number
125117|NCT00596427|Secondary|Glucagon AUC|"Changes from baseline of glucagon AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||picograms (pg)/milliter (ml) x min||Standard Error|Mean
125118|NCT00596427|Secondary|Postprandial Fractional Cholic Acid Synthesis|Changes from baseline in fractional cholic acid synthesis after 12 weeks of colesevelam or placebo treatment were evaluated. Fractional cholic acid synthesis represents the relative amount of cholic acid that is made from newly synthesised cholesterol.|baseline and 12 weeks|||Percent new cholic acid||Standard Error|Mean
125119|NCT00596427|Secondary|Fasting Fractional Cholesterol Synthesis|Changes from baseline in fasting fractional cholesterol synthesis after 12 weeks of colesevelam or placebo treatment. Fractional Cholesterol synthesis represents the fraction of free cholesterol in plasma that was newly synthesised.|baseline and 12 weeks|||Percent new cholesterol||Standard Error|Mean
125120|NCT00596427|Secondary|Fasting Fractional De Novo Lipogenesis (DNL)|Changes from baseline in fasting fractional DNL after 12 weeks of colesevelam or placebo treatment were calculated. Fractional DNL represents the fraction of palmitate in very-low density lipoproteins-triglycerides (VLDL-TG) that was newly synthesized.|baseline and 12 weeks|||percent new palmitate||Standard Error|Mean
125121|NCT00596427|Primary|Rate of Appearance of Exogenous Glucose (Glucose Absorption)|Change from baseline of the rate of appearance of oral glucose after 12 weeks of placebo or colesevelam treatment. Mean of values obtained between 0 and 300 min is reported.|baseline and 12 weeks|||µmol per kg FFM per minute (min)||Standard Error|Mean
125122|NCT00596427|Primary|Fasting Glycogenolysis|Change from baseline of fasting glycogenolysis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||µmol per kilograms (kg) FFM per min||Standard Error|Mean
125123|NCT00596427|Primary|Fasting Gluconeogenesis|Change from baseline of fasting gluconeogenesis after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||micromoles (µmol) per kg FFM per min||Standard Error|Mean
125124|NCT00596427|Other Pre-specified|Glucose AUC|"Changes from baseline of glucose AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||millimoles (mmol)/l x min||Standard Deviation|Mean
125125|NCT00596427|Other Pre-specified|Glycosylated Hemoglobin (HbAlc)|Changes from baseline of HbA1c after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||percentage||Standard Deviation|Mean
125126|NCT00596427|Primary|Fasting Endogenous Glucose Production (EGP)|Changes from baseline of fasting EGP after 12 weeks of placebo or colesevelam treatment.|baseline and 12 weeks|||umol per kg Fat-Free Mass (FFM) per min||Standard Error|Mean
125127|NCT00596427|Secondary|Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC|"Changes from baseline of total GIP-1 AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||pmol/l x min||Standard Deviation|Mean
125128|NCT00596427|Secondary|Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC)|"Changes from baseline of total GLP-1 AUC after 12 weeks of placebo or colesevelam treatment.~AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes"|baseline and 12 weeks|||picomoles (pmol)/Liter (L) x minute (min||Standard Deviation|Mean
125129|NCT00597558|Secondary|Subjects on OIT Will Have a Decrease in Serum CAP-FEIA to Egg Over the Course of the Study.||End of the study||||||
125130|NCT00597558|Secondary|Subjects on OIT Will Have a Decrease in Wheal Size of an Egg Protein Skin Prick Test Placed at the End of the Study on OIT Compared With Wheal Size of Egg Protein Skin Test at Entry.||End of the study||||||
125131|NCT00597558|Primary|Negative Double-blind, Placebo-controlled Food Challenge (DBPCFC) to Egg After Egg OIT Treatment|Subjects on egg OIT will have a negative double-blind, placebo-controlled food challenge (DBPCFC) to egg when the IgE to egg is < 7 kU/L or 90% of entry level IgE or SPT <= 5mm.|End of the study|||participants with negative DBPCFC|||Number
125132|NCT00597545|Primary|Number of Participants With Improved Neuropsychometric Changes|Battery of neuropsychometric tests to evaluate a variety of cognitive functions.|Post-operatively at 1 day|||participants|||Number
125134|NCT00597506|Primary|Progression Free Survival (PFS)|8 week PFS|interval between start of treatment and 8-week|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.||proportion of participants||90% Confidence Interval|Number
125135|NCT00597506|Primary|Overall Response|Overall response is composed of complete responses and partial responses. Complete response (CR): disappearance of all target lesions; Partial response: at least a 30 percent decrease in the sum of the longest diameter of the target lesions taking as reference the baseline sum longest diameter. Response is assessed at each subject's restaging, approximately ever 2 months.|Measured 1 month after the last treated subject came off treatment|50 patients were enrolled and received bevacizumab at 10mg/kg every 2 weeks and everolimus at 10mg orally daily. However, only 49 patients were evaluable for progression. One patient who received less than 1 cycle of the regimen and died from a non-treatment-related illness was not included in the analysis.||percentage of participants|||Number
125136|NCT00597493|Secondary|Pharmacokinetics: AUC-24|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. AUC-24 refers to area under the plasma concentration-time curve from 0 to 24 hours. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAEDs) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.||ug*H/L||Geometric Coefficient of Variation|Geometric Mean
125137|NCT00597493|Secondary|Pharmacokinetics: T-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. T-max refers to time to maximum concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.||hours||Full Range|Median
125138|NCT00597493|Secondary|Pharmacokinetics: C-max|Blood sampling for sorafenib pharmacokinetics was performed on days 1 and 28 of cycle 1 and was obtained before and at 0.5, 1, 2, 4, 6, 8, and 24 h after the morning dose. C-max refers to maximum plasma concentration. The pharmacokinetics of those patients taking enzyme-inducing antiepileptic drugs (EIAED) and those who were not were analyzed separately.|13 months|9 participants who were on EIAEDs had 24 hour sorafenib concentration versus time profiles from both day 1 and day 28 of cycle 1. 14 participants who were not on EIAEDs underwent similar assessment for day 1 but only 10 of these participants had samples available for day 28 measurements.||ug/L||Geometric Coefficient of Variation|Geometric Mean
125139|NCT00597493|Secondary|Safety and Toxicity of Combination|Number of participants experiencing a toxicity of at least grade 3 that was deemed possibly, probably, or definitely related to the treatment.|16 months|||participants|||Number
125140|NCT00597493|Primary|6 Month Progression Free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|||percentage of patients||95% Confidence Interval|Number
125141|NCT00597428|Secondary|Treatment Effectiveness|Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective|Weeks 1-12|Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12).||units on a scale||Standard Deviation|Mean
125142|NCT00597428|Secondary|Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular|Weeks 1-12|||units on a scale||Standard Deviation|Mean
125143|NCT00597428|Secondary|Responder Rate|Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.|Up to 12 weeks|||participants|||Number
125144|NCT00597428|Secondary|First Post-dose SBM|The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.|24 and 48 hours post-dose|||participants|||Number
125145|NCT00597428|Secondary|Change From Baseline in Mean Weekly SBM Frequency|For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.|Baseline, Week 12, and Weeks 1-12|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
125146|NCT00597428|Primary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8||Baseline and Week 8|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
125147|NCT00597402|Secondary|Number of Patients Experiencing a Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of times a grade ≥ 4 hematologic or grade ≥ 3 non-hematologic toxicity was experienced|55 months|||participants|||Number
125148|NCT00597402|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|55 months|||participants|||Number
125150|NCT00597402|Primary|16-month Overall Survival (OS)|Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.|16 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
125151|NCT00597376|Secondary|Six Month Levels of Inflammation and Oxidative Stress Markers(as a Percent of Baseline Levels) After Daily Treatment With Cerefolin NAC and a Multivitamin or a Multivitamin Only|Outcome measures were 6-month levels of highly sensitive c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6), malondialdehyde, and potential anti-oxidant (PAO)in blood samples as a percent of baseline value.|6 months|All participants in Intent-to-Treat were included with last observation carried forward.||percent of baseline level||95% Confidence Interval|Mean
125152|NCT00597376|Secondary|Tolerability of Cerefolin NAC and a Multivitamin Versus a Multivitamin Only|Mean study product compliance was measured as the actual number of study product tablets taken as a percent of the maximum study product tablets that could have been taken during the intervention period.|6 months|All participants in Intent-to-Treat cohort were included.||percent of study drug taken||Standard Error|Mean
125153|NCT00597376|Primary|Six Month Blood Levels of Homocysteine, Glutathione, and the Ratio of Aβ42 to Aβ40 (as a Percent of Baseline Levels) After Daily Intake of Cerefolin NAC Plus a Multivitamin Versus a Multivitamin Only|Primary outcome markers were plasma homocysteine (tHcy), glutathione, and the ratio of amyloid proteins, Aβ42 and Aβ40. Plasma tHcy and glutathione were assayed using a high performance liquid chromatography (HPLC) with fluorescence detection method. Enzyme-linked immunosorbent assays (ELISA) were used for Aβ42 (Wako Chemicals USA, Inc., Richmond, VA) and Aβ40 (Invitrogen Corporation, Canarillo, CA) detection. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess the primary biomarker level at 6 months versus baseline. Six month levels in biomarker outcomes were compared using t-tests of the logarithmically transformed values and the antilogarithm was applied to the SDs obtain 95% confidence intervals (95% CIs). A significant difference between treatments was needed for at least one of the primary outcome variables (tHcy, glutathione, or the Aβ42 to Aβ40 ratio) to declare the study positive.|6 months|The Intent-to-Treat (ITT) cohort included randomized subjects taking at least one study treatment dose. Primary analyses utilized Last Observation Carried Forward (LOCF) to assess 6 month levels in the primary biomarkers. 2-sided, t-test p-value for group differences was only significant (<0.05) for 6-month homocysteine level.||percent of baseline level||95% Confidence Interval|Mean
125154|NCT00597272|Primary|Toxicity|Toxicity will be graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|2 years|||participants|||Number
125155|NCT00597207|Secondary|Sustained ROSC, Survival to 24 Hours, Hospital Discharge With a MRS ≤ 3, Process Outcomes: Number of Shocks, Duration of Pulselessness From 911 Call to ROSC, Hands-on Interval or Other Measures of CPR Quality||during the case||||||
125156|NCT00597207|Secondary|Neurology||30 days||||||
125157|NCT00597207|Primary|Hospital Discharge|Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.|From time of first contact until hospital discharge, up to 90 days.|||participants|||Number
125158|NCT00597116|Secondary|Overall Survival (OS)||Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.||Months||95% Confidence Interval|Median
125159|NCT00597116|Secondary|Progression-free Survival (PFS)|Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.|Assessed from baseline to 12 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.||Months||95% Confidence Interval|Median
125160|NCT00597116|Secondary|Number of Participants With Objective Response.|Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.||Participants|||Number
125161|NCT00597116|Primary|Number of Participants With Disease Control.|Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD.|Assessed at 2 months.|Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment.||Participants|||Number
125162|NCT00597038|Secondary|Number of Participants With 12 Month Overall Survival (OS)|Phase II - To determine Overall Survival of patients treated with the combination of dasatinib and DTIC at 12 months.|12 Months|All participants||participants|||Number
125163|NCT00597038|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Phase II - PFS Rate in patients receiving dasatinib 70 mg orally (PO) twice a day (BID). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved. Stable disease was defined as maintenance of the sum of lesions diameters between a 30% reduction and a 20% increase of overall tumour size over 12 weeks or longer.|6 Months|Patients receiving dasatinib at 70 mg PO BID||participants|||Number
125164|NCT00597038|Primary|Phase II - Number of Participants With Overall Response (OR)|Phase II - To determine the overall response rate (ORR) of the combination of dasatinib and DTIC by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Tumor assessments were made at baseline and at the end of every second cycle (i.e. every 6 weeks). Partial and complete responses were defined by the best treatment response achieved.|1 Year 6 Months|Patients receiving dasatinib at 70 mg PO BID||participants|||Number
125165|NCT00597038|Primary|Recommended Phase II Dose|To determine the maximum tolerated dose of dasatinib twice a day when given with dacarbazine. Adverse events were graded using Common Terminology Criteria for Adverse Events version 3.0. Dose-limiting toxicities are defined as any grade 4 haematological toxicity (except asymptomatic grade 4 neutropenia for =/< 7 days); prolonged grade 3 or 4 thrombocytopenia (47 days) or thrombocytopenia associated with bleeding, requiring platelet transfusion; any grade 3 or 4 nonhaematological toxicity despite optimal supportive care; any toxicity considered unacceptable by the study principal investigator.|1 Year 3 Months|All participants in Arm A||mg|||Number
125166|NCT00597012|Secondary|SF-36 Physical Functional Status Scale - Difference From Baseline|Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity.|6 months|||Score||95% Confidence Interval|Mean
125167|NCT00597012|Secondary|KOOS Pain - Difference From Baseline|Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization.|Baseline to 6 months|||Score||95% Confidence Interval|Mean
125168|NCT00597012|Primary|WOMAC Functional Status - Difference From Baseline|Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 6 months after randomization.|Baseline and 6 months|||Score||95% Confidence Interval|Mean
125169|NCT00596960|Secondary|Heavy Drinking Days (Greater or Equal to 4 Drinks)|This was measured as heavy drinking days per 30 day time frame. A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. A heavy drinking day was considered to be 4 or greater drinks during a day.|6-months|||heavy drinking days||Standard Deviation|Mean
125170|NCT00596960|Primary|Percent Days Abstinent From Alcohol at 6 Months|Alcohol use was measured for 30 days at baseline, 3-months and 6-months using the time-line follow back method. Percent days abstinent was measured by determining: days abstinent/30days X 100=%days abstinent.|6-months|||percentage of days abstinent||Standard Deviation|Mean
125171|NCT00596960|Primary|The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.|A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. The number of drinks per week was measured for 30 a day time frame at baseline, 3 months and 6-months.|6-months|||Standard Alcohol drinks||Standard Deviation|Mean
125172|NCT00596947|Secondary|The Number of Participants With Weight Gain|Height, weight will be used to calculate change in BMI for all participants.|12 months|unable to interpret results due to low number of patients enrolled.||participants||Standard Deviation|Mean
125173|NCT00596947|Secondary|The Number of Participants With Post Transplant Diabetes Mellitus|"Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months.~Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants."|pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months|unable to interpret results due to low number of patients enrolled.||participants||Standard Deviation|Mean
125174|NCT00596947|Secondary|The Number of Participants With Bone Disease|Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.|baseline (within 1 month post-transplant), 3, 6, 12 and 24 months|unable to interpret results due to low number of patients enrolled.||participants||Standard Deviation|Mean
125175|NCT00596947|Secondary|The Number of Participants With Hyperlipidemia|Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.|12 months|Unable to interpret data due to low number of patients enrolled.||participants||Standard Deviation|Mean
125176|NCT00596947|Secondary|The Number of Participants With Hypertension|The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.|12 months|unable to interpret results due to low number of patients enrolled.||participants||Standard Deviation|Mean
125177|NCT00596947|Secondary|The Number of Participants With Malignancy|Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.|12 months|Unable to interpret data due to low number of patients enrolled.||participants||Standard Deviation|Mean
125178|NCT00596947|Secondary|The Number of Participants With Infections|Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.||participants||Standard Deviation|Mean
125179|NCT00596947|Secondary|The Number of Participants With Leukopenia|All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).|12 months|unable to interpret results due to low number of patients enrolled.||participants||Standard Deviation|Mean
125240|NCT00596271|Secondary|Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28||day 28 and 56||||||
125180|NCT00596947|Secondary|The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.|The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.|12 months|unable to interpret results due to low number of patients enrolled.||participants||Standard Deviation|Mean
125181|NCT00596947|Primary|Participant Survival|The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.|6 and 12 months|data not interpretable due to low patient enrollment||participants|||Number
125182|NCT00596947|Primary|The Number of Participants With Graft Survival|The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.|6 and 12 months|data not interpretable due to low patient enrollment||participants|||Number
125183|NCT00596947|Secondary|Participant Renal Function as Measured by 24 Hour Urine Collection|Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.|3 and 12 months post-transplant|Unable to interpret data due to low number of patients enrolled.||milliters/minute||Standard Deviation|Mean
125184|NCT00596947|Secondary|Participant Renal Function as Measured by MDRD Formula|The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.|3, 6 and 12 months|Unable to interpret data due to low number of patients enrolled.||milliters/minute||Standard Deviation|Mean
125185|NCT00596947|Secondary|The Length of Stay Associated With Hospital Readmissions|The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.|12 months|Unable to interpret data due to low number of patients enrolled.||days||Standard Deviation|Mean
125186|NCT00596947|Secondary|The Number of Participants With Hospital Readmissions|The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.|12 months|Unable to interpret data due to low number of patients enrolled.||participants||Standard Deviation|Mean
125187|NCT00596947|Secondary|Length of Hospital Stay After Transplant|The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.|12 months|unable to interpret results due to low number of patients enrolled.||days||Standard Deviation|Mean
125188|NCT00596947|Secondary|The Number of Participants With Treatment Failures|This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)|12 months|Unable to interpret data due to low number of patients enrolled.||participants|||Number
125189|NCT00596947|Primary|The Number of Participants With Acute Rejection Episodes|Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.|6 and 12 months post-transplant|data not interpretable due to low patient enrollment||participants|||Number
125190|NCT00596934|Secondary|Insulin Resistance: Homeostatic Model Assessment (HOMA) at 12 Months|HOMA values in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||mU/L x mg/dL||Standard Deviation|Mean
125191|NCT00596934|Secondary|Fasting Triglycerides Value at 12 Months|Fasting triglyceride value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||mg/dL||Standard Deviation|Mean
125192|NCT00596934|Secondary|Fasting Glucose Value at 12 Months|Fasting glucose value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||mg/dL||Standard Deviation|Mean
125193|NCT00596934|Secondary|Liver Function Test: Aspartate Aminotransferase (AST) Values at 12 Months|AST value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||IU/L||Standard Deviation|Mean
125194|NCT00596934|Secondary|Liver Function Test: Alanine Aminotransferase (ALT) Values at 12 Months|ALT value in subjects that completed 12 months of metreleptin treatment.|1 year|7 subjects who completed 12 months of metreleptin treatment.||IU/L||Standard Deviation|Mean
125195|NCT00596934|Secondary|Liver Fat Percentage by Magnetic Resonance Imaging (MRI - Dixon Method) at 12 Months|For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs’) fractional fat content throughout the liver in a few breath-hold intervals.|1 year|||liver fat percentage||Standard Deviation|Mean
125196|NCT00596934|Secondary|Body Weight at 12 Months|Body weight (kg) after one year of treatment on metreleptin for patients that completed 12 months of metreleptin treatment.|1 year|Subjects that completed 12 months of metreleptin treatment.||kg||Standard Deviation|Mean
125197|NCT00596934|Primary|Non-alcoholic Steatohepatitis Score as Determined by Liver Histopathology at 12 Months|Non-alcoholic steatohepatitis (NASH) score after approximately one year of treatment with metreleptin. Total NASH scores can range from 0 to 14. The higher the NASH score the more severe the liver disease.|1 year|Individuals who completed the year of metreleptin treatment and had follow-up liver biopsies after one year.||units on a scale||Standard Deviation|Mean
125198|NCT00596830|Secondary|Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels||Cycles 1 and 4 (predose) and at end of treatment|This study was terminated early due to futility. As such, these data were not analyzed.|||||
125199|NCT00596830|Secondary|Number of Participants With Total Anti-drug Antibodies (ADA)|ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.|Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose|All participants who received figitumumab (CP-751,871).||participants|||Number
125200|NCT00596830|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmin was not summarized.|||||
125201|NCT00596830|Secondary|Maximum Observed Plasma Concentration (Cmax) for Figitumumab||Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose|This study was terminated early due to futility. As such, Cmax was not summarized.|||||
125202|NCT00596830|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state."|Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore EQ-5D data were not analyzed.|||||
125203|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.|||||
125204|NCT00596830|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months|Due to futility, the study was terminated early; therefore these data were not analyzed.|||||
125205|NCT00596830|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||percentage of participants||95% Confidence Interval|Number
125206|NCT00596830|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and >=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).|At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||months||95% Confidence Interval|Median
125207|NCT00596830|Primary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline until death, assessed monthly after end of treatment, up to 30 months|All randomized participants where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.||months||95% Confidence Interval|Median
125208|NCT00596817|Secondary|Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 24 of the double-blind period (Counted From Double-blind Baseline)|FAS; OC||units on a scale||Standard Error|Mean
125209|NCT00596817|Secondary|Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)||Week 24 of the double-blind period|FAS; OC||percentage of patients|||Number
125210|NCT00596817|Secondary|Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)||Week 24 of the double-blind period (Counted From Open-label Baseline)|FAS; OC||percentage of patients|||Number
125211|NCT00596817|Secondary|Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC||units on a scale||Standard Error|Mean
125212|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC||units on a scale||Standard Error|Mean
125213|NCT00596817|Secondary|Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment|The Hamilton Depression Scale – 17 items (HAM-D-17) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 52. The higher the score, the more severe.|Double-blind Baseline and Week 24 of the double-blind period|FAS; OC||units on a scale||Standard Error|Mean
125214|NCT00596817|Secondary|Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment||Double-blind Baseline and Week 24 of the double-blind period|FAS; observed cases (OC)||units on a scale||Standard Error|Mean
125215|NCT00596817|Secondary|Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator||Within 64 weeks of the double-blind period|FAS||percentage of patients who relapsed|||Number
125216|NCT00596817|Primary|Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Within first 24 weeks of the double-blind period|FAS||percentage of patients who relapsed|||Number
125217|NCT00596752|Secondary|Cardiovascular Morbidity During the Course of the Study (up to 196 Days)|Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study.|During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.||participants|||Number
125218|NCT00596752|Secondary|Cardiovascular Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.||participants|||Number
125219|NCT00596752|Secondary|All-cause Mortality During the Course of the Study (up to 196 Days)||During the course of the study (up to 196 days)|Safety Set consists of all randomized subjects who received at least one dose of trial medication.||participants|||Number
125220|NCT00596752|Secondary|Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment|The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 577 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
125221|NCT00596752|Secondary|Minor Amputations at 24 Weeks After the End of Study Drug Treatment|"Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.~The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below."|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 613 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
125222|NCT00596752|Secondary|Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment|Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||mmHg||Standard Deviation|Mean
125223|NCT00596752|Secondary|Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)|The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study.|During the course of the study (up to 196 days)|Full Analysis Set (FAS) consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
125241|NCT00596271|Primary|Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies|"anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to Outcome 2 within outcome measure section"|Day 56|Per Protocol Population includes all randomized subjects without major protocol deviations||titers||95% Confidence Interval|Geometric Mean
125224|NCT00596752|Secondary|Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment|In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 465 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
125225|NCT00596752|Secondary|Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment|Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with “No“ and no visit value is specified, the visit value will be set to 0 for the analysis.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||millimeters (mm)||Standard Deviation|Mean
125226|NCT00596752|Secondary|Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 24 weeks after the end of study drug treatment|Of the 838 subjects in the Full Analysis Set (FAS), 568 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
125227|NCT00596752|Primary|Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment|Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated.|At 24 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
125228|NCT00596752|Primary|Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment|The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point.|At 12 weeks after the end of study drug treatment|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints.||participants|||Number
125229|NCT00596687|Primary|Mean Blood Glucose Concentration|blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment|hospital stay days 2-10|||mg/dl||Standard Deviation|Mean
125230|NCT00596687|Secondary|# Participants With Hypoglycemic Events|number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl)|hospital stay days 2-10|||participants|||Number
125231|NCT00596635|Primary|Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.|Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.|6 months|||Urine cultures|||Number
125232|NCT00596635|Secondary|Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had >100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.|6 months|||Participants|||Number
125233|NCT00596635|Secondary|Number of Participants With E.Coli Isolated From Urine Culture|Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.|6 months|||Participants|||Number
125234|NCT00596622|Secondary|Young Mania Rating Scale|Gold standard scale to measure mania, Range 0 - 60; 12 - 15 mild mania; 15 - 20 moderate mania; >20 severe mania|Baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
125235|NCT00596622|Primary|17-item Hamilton Depression Rating Scale (HDRS)|17-item HDRS is gold standard for measurement of depression with a range from 0 - 52. 10 - 14: mild depression; 14-20 moderate depression; >20: severe and very severe depression.|Measured at Baseline and after 8 weeks of treatment|||units on a scale||Standard Deviation|Mean
125236|NCT00596362|Primary|The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease|At conclusion of study, up to 5 days|||participants|||Number
125237|NCT00596271|Primary|GMT for Hepatitis A Virus (HAV) Antibody at Day 28||Day 28|||titers||95% Confidence Interval|Geometric Mean
125238|NCT00596271|Secondary|Safety|Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)|until 6 month after last vaccination||||||
125239|NCT00596271|Secondary|GMT and SCR for PRNT at Day 28 and HAV at Day 56||day 28 and 56||||||
125242|NCT00596167|Primary|Intradialytic Clearance of Levofloxacin, Gentamicin and Vancomycin in Patients Receiving Short-daily Hemodialysis|"The intradialytic clearance of levofloxacin, gentamicin and vancomycin will be determined in patients receiving short-daily hemodialysis.~(Of important note, due to technical issues the levofloxacin data was not able to be used for the analysis. Only the gentamicin and vancomycin data was analyzed.)"|Serum concentrations for each drug will be determined from blood samples at 0 (pre-infusion), 30, 60 minutes (end of infusion).|||ml/min||Full Range|Median
125243|NCT00596102|Secondary|Adverse Events||6, 12, 24, 36, 48 and 60 months after 1st vaccination||||||
125244|NCT00596102|Secondary|Geometric Mean Titers||6, 12, 36, 48 and 60 months||||||
125245|NCT00596102|Secondary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)||6, 12, 36, 48 and 60 months after 1st vaccination||||||
125246|NCT00596102|Primary|Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)|first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302|24 months after the first vaccination|subjects enrolled into this study who planned to participate in the long-term immunogenicity part and received IC51 in the respective preceeding study||percentage of subjects||95% Confidence Interval|Number
125247|NCT00596011|Other Pre-specified|Effect of Polyphenon E on the Fundamental Molecular Pathways|Explore the effects of Polyphenon E on the fundamental molecular pathways contributing to chemopreventive activity of Polyphenon E in the prostate. This exploratory aim is ongoing.|12 months||||||
125248|NCT00596011|Other Pre-specified|Change in Scores - Lower Urinary Tract Symptom (LUTS)|Change in score from baseline to 1 year. LUTS represent a common conglomeration of storage, voiding, and post-micturition symptoms with reported debilitating effect on quality of life. Symptom severity related to urinary frequency, nocturia, weak urinary stream, hesitancy, intermittency, incomplete bladder emptying and urinary urgency are assessed. We utilized the American Urological Association Symptom Score for the evaluation LUTS in this patient population. Symptom Frequency Scores: 0 = Not at all, 1 = Less than 1 time in 5, 2 = Less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. Total Symptom Score = Sum of individual scores of the 7 symptoms. (minimum possible score=0; maximum possible score =35; Range of scores and significance: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms.|1 year|Participants with LUTS symptom scores available at baseline and at one year||units on a scale||Standard Deviation|Mean
125249|NCT00596011|Secondary|Median Serum Total Prostatic Specific Antigen (tPSA)|Median ng/mL serum tPSA post treatment, per treatment arm.|12 months|All participants||ng/mL||95% Confidence Interval|Median
125250|NCT00596011|Secondary|Occurrence of Grade 3 or Higher Adverse Events (AEs)|Number of participants with AEs grade 3 or higher, per treatment arm.|12 months|All participants||participants|||Number
125251|NCT00596011|Secondary|Treatment Emergent Adverse Events (AEs)|Safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN or ASAP. Number of participants with AEs Possibly or Probably related to treatment.|12 months|All participants||participants|||Number
125252|NCT00596011|Primary|Rate of Progression From HGPIN to ASAP or PCa|Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.|12 months|Baseline HGPIN participants||participants|||Number
125253|NCT00596011|Primary|Rate of Progression to Prostate Cancer (PCa)|Number of participants with diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP) who progressed to prostate cancer (PCa) at one year.|12 months|All participants||participants|||Number
125254|NCT00595959|Secondary|Volumetric Plaque Reduction|Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.|measured at time of procedure|Per protocol||millimeters cubed||Standard Deviation|Mean
125255|NCT00595959|Secondary|Adverse Events|Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.|Through 12 Months|||events|||Number
125256|NCT00595959|Secondary|Rutherford Classification|Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst|Through 12 Months|63 at baseline; 62 at 30days and 6 months; 63 at 12 months||units on a scale of 0-6||Standard Deviation|Mean
125257|NCT00595959|Post-Hoc|Walking Impairment Questionare (WIQ)|Measures difficulty in walking before and after treatment. Defined by comparing the responses to a WIQ at pre-treatment with the responses at 30 days, six (6) months and 12 months post-procedure. Higher score is better (scale 0-100).|measured at each follow-up period|65 patients at baseline and 30 days; 64 at 6 mo; 63 at 12 mo||units on a scale 0-100||Standard Deviation|Mean
125258|NCT00595959|Secondary|Patients With >50% Stenosis Measured by Duplex Ultrasound|Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).|Through 12 Month|per protocol; 65 patients at 30 days; 59 at 6 months and 46 at 12 months||percent of patients|||Number
125259|NCT00595959|Secondary|Assisted Secondary Patency|Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site|Through 12 Month|65 at 30 days; 64 at 6 months; 63 at 12 months||% pts free from secondary patency|||Number
125260|NCT00595959|Secondary|Assisted Primary Patency|Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion|Through 12 Months|65 at 30 days; 64 at 6 months; 63 at 12 months||% pts free from assisted primary patency|||Number
125261|NCT00595959|Secondary|Clinical Success|Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure|measured post discharge thorugh 12 Months follow-up|65 patients at 30 days; 59 at 6 months; 46 at 12 months||percent of patients|||Number
125262|NCT00595959|Secondary|Minimum and Maximum Lumen Diameters|Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).|measured at time of procedure|Analysis per protocol||millimeters||Standard Deviation|Mean
125280|NCT00595790|Secondary|SCR at Day 10, 28 and 35||Day 10, 28 and 35||||||
125263|NCT00595959|Secondary|Procedural Success|Acute procedural success, defined as achievement of </= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of </=30%.|measured at time of procedure|Per protocol. All enrolled patients||percent with </=30% RS|||Number
125264|NCT00595959|Primary|Major Adverse Events|The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.|From discharge through the 6 month follow-up|||events|||Number
125265|NCT00595959|Primary|Laser Success|The primary efficacy endpoint is laser success, defined as achieving >/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.|Measured at time of procedure|Per protocol||percent reduction||Standard Deviation|Mean
125266|NCT00595946|Secondary|Treatment Effectiveness (Patient Reported Outcome)|Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12). Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.|Weeks 1-12|||units on a scale||Standard Deviation|Mean
125267|NCT00595946|Secondary|Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity|Ratings over 12-week treatment period were averaged and difference from baseline score calculated; Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls); Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe; Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular.|Weeks 1-12|||units on a scale||Standard Deviation|Mean
125268|NCT00595946|Secondary|Responder Rate|Number of participants, who remained on treatment for at least 8 weeks, and reported response (>=3 SBMs) for at least 50% of weeks on study.|Up to 12 weeks|||participants|||Number
125269|NCT00595946|Secondary|First Post-dose Spontaneous Bowel Movement|The number of participants that experienced first post-dose Spontaneous Bowel Movement at 24 and 48 hour of dose initiation.|24 and 48 hours post-dose|||participants|||Number
125270|NCT00595946|Secondary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement Frequency|Average weekly Spontaneous Bowel Movement frequency rating was calculated from data collected from Week 1-12|Baseline, Week 12, and Weeks 1-12|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
125271|NCT00595946|Primary|Change From Baseline in Mean Weekly Spontaneous Bowel Movement Frequency|Outcome analyzed for subjects without dose reduction prior to Week 8, per protocol-specified primary outcome.|Baseline and Week 8|||Spontaneous Bowel Movements/Week||Standard Deviation|Mean
125272|NCT00595920|Secondary|Evaluate Changes in Annualized Relapse Rate||Annually||||||
125273|NCT00595920|Secondary|Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression||Annually||||||
125274|NCT00595920|Primary|Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI)|This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data.|Annually|This extension study was discontinued due to financial constraints. No efficacy results are summarized due to the small number of patients who received full treatment and follow-up.|||||
125275|NCT00595881|Primary|Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone.|The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator. Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.|18 mos|Assuming a baseline sensitivity of clinical exam alone similar to that previously published (86%), type 1 error rate 0.05, and intraclass correlation coefficient of 0.5 for lesions within patients, we estimated a sample size of 393 lesions would provide 80% power to detect at least a 9% difference in the sensitivity of CE+EUS compared to CE alone.||Ratio as a percentage||95% Confidence Interval|Number
125276|NCT00595868|Secondary|7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million|7 day point prevalent abstinence 6 months after enrolling in the study was determined by two steps: (1) A report of no days of smoking for the 7 days prior to the 6 month on the Time Line Follow Back obtained at a telephone call 6 months after enrollment; (2) Those who reported no smoking for the prior 7 days came to our lab for breath carbon monoxide (CO) measurement to confirm abstinence. Breath CO had to be less than 10 parts per million for the participant to be classified as abstinent.|6 months|||participants|||Number
125277|NCT00595868|Primary|Number of Participants With a Quit Attempt|A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.|6 months|||participants|||Number
125278|NCT00595790|Secondary|Safety|AEs, Local and systemic tolerability, Safety laboratory parameters|Study duration||||||
125279|NCT00595790|Secondary|GMT at Day 10, 28, 35 and 56||Day 10, 28, 35 and 56||||||
125281|NCT00595790|Primary|SCR (Seroconversion Rate) at Day 56|Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer|day 56|The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation||percentage of participants||95% Confidence Interval|Number
125282|NCT00595764|Secondary|Overall Health- Short Form (36) Health Survey|"Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales.~The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning."|6 months|All participants who completed 1 or more SF-36 assessments were included in the analysis.||Scores on a scale||Standard Error|Mean
125283|NCT00595764|Secondary|Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.|The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.|6 months|All participants who completed one or more ASI assessments were included in the analysis.||Scores on a scale||Standard Error|Mean
125284|NCT00595764|Secondary|Cocaine Abstinence|Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.|6 months|All participants provided one or more urine screens thus data was based on all participants.||weeks of abstinence||Standard Deviation|Mean
125285|NCT00595764|Secondary|Treatment Completion|The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.|6 months|All participants who entered treatment were evaluated for treatment completion.||participants|||Number
125286|NCT00595764|Primary|Illicit Opioid Abstinence|number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.|6 months|Repeated measures analysis of variance was used to evaluate differences between groups in the maximum number of consecutive weeks of opioid abstinence for the first and second 12 weeks of treatment. We coded missing urine specimens as positive for opioids in our analysis, thus all participants provided data.||Weeks of Abstinence||Standard Deviation|Mean
125287|NCT00595582|Primary|Neuropsychological Scores in Patients With MCI or Mild AD.||within the next three years|No data were collected as this study was terminated.||units on a scale||Standard Deviation|Mean
125288|NCT00595556|Secondary|Change in Gamma-glutamyl Transferase (GGT) Concentration|This outcome measure looks at the change in blood levels of this enzyme assay from baseline, and then after 6 weeks (midpoint), and then at the endpoint (12 weeks). The analysis takes into account all three time points, and reports the average change between each of the three time points.|12 weeks (from initiation to end of treatment)|||Units/Liter||Standard Deviation|Mean
125289|NCT00595556|Secondary|Change in the Urge to Drink Alcohol as Measured by the Alcohol Urge Questionnaire (AUQ)|This is the change in measured urge to drink alcohol as measured by the Alcohol Urge Questionnaire (AUQ), measured every 2 weeks from baseline until the last week of the study (over twelve weeks, 7 timepoint measurements of AUQ, 6 calculated changes). It is reported in terms of change per visit (every 2 weeks). AUQ measures a feeling state, and uses a 7 point (1-7)Likert scale for each of 8 items (questions). The lowest urge score is 8 (representing less urge to drink), and the highest would be tabulated as 56 (meaning more urge to drink). Repeated measures SPPS linear mixed models used.|baseline to the end of 12 weeks in treatment|||units on a scale/visit||Standard Deviation|Mean
125290|NCT00595556|Secondary|Change in Number of Drinks Per Week by Week|This outcome measure represents the change in the total number of standard drinks per week (weekly data) from baseline to the end of week twelve. This was analyzed using weekly measurements from baseline to week 12 week of the study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment|The analysis was intention to treat and last observation carried forward||drinks/week||Standard Deviation|Mean
125291|NCT00595556|Primary|Weekly Rate of Change in Abstinent Days|This outcome measure analyzed the weekly rate of change in number of abstinent days over the twelve weeks of the study from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS proc mixed), by interaction with time (week).|baseline to the end of 12 weeks in treatment|||days/week||Standard Error|Mean
125292|NCT00595556|Primary|Change in Number of Heavy Drinking Days (i.e., 5 or More Drinks Per Day for Men, and 4 or More Per Day for Women)Per Week, by Week|This outcome measure represents the change in number of heavy drinking days (i.e., 5 or more drinks per day for men, and 4 or more per day for women)per week, from baseline to the end of week twelve. This was analyzed using weekly measurements over the 12 week study period (thirteen time points, 12 measurements)with a repeated measures analysis (SPSS linear mixed models), by interaction with time (week).|baseline to the end of 12 weeks in treatment|||Days/week||Standard Deviation|Mean
125293|NCT00595530|Secondary|Self-reported Pain Scores||Every 4 hours||||||
125294|NCT00595530|Secondary|Intravenous Opiate Utilization||Every 4 hours||||||
125295|NCT00595530|Primary|The Number of Participants That Experience Side Effects|How many participants experienced side effects while undergoing treatment with the study drug?|Daily while inpatient and once a week for first 4 weeks post discharge|||participants|||Number
125296|NCT00595517|Primary|Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period||up to 52 weeks|||Participants|||Number
125297|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment||up to 24 weeks after treatment|||participants|||Number
125298|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment||up to 12 weeks after treatment|||participants|||Number
125299|NCT00595517|Secondary|Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment||up to 4 weeks after treatment|||Participants|||Number
125300|NCT00595504|Primary|Change in Abdominal Fat (DEXA).|A comparison between the ramelteon group and the placebo group of change in abdominal fat measured by a DEXA scan, assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.||g||Standard Deviation|Mean
125301|NCT00595504|Primary|Change in Insulin Resistance as Measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).|A comparison between the ramelteon group and the placebo group of change in insulin resistance measured by the homeostatic model assessment of insulin resistance (HOMA-IR), assessed at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.||HOMA score||Standard Deviation|Mean
125302|NCT00595504|Primary|Change in Waist Circumference|A comparison between the ramelteon group and the placebo group in change in waist circumference (measured in cm) measured at Baseline and Week 8.|Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study.||cm||Standard Deviation|Mean
125303|NCT00595465|Secondary|Safety and Adverse Events||Day 56||||||
125304|NCT00595465|Secondary|Seroconversion Rate||Day 56||||||
125305|NCT00595465|Primary|Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody||Day 56|Per Protocol Population (PP Population, N= 364): includes all subjects randomized who received at least one dose of study medication without any major protocol violations identified at the blind data review meeting.||titers||Standard Deviation|Mean
125306|NCT00595413|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug up to 30 days after the last dose of study drug, assessed up to Week 38|ITT population included all randomized participants who received at least 1 study treatment dose.||participants|||Number
125307|NCT00595413|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Responses at Week 26|The EULAR response criteria evaluate change in DAS28 scores represented as “good response”, “moderate response”, or “no response” considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have “good” or “moderate” EULAR response if at the time of assessment, their DAS28 score was less than or equal to (<=) 5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2.|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
125308|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
125309|NCT00595413|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
125310|NCT00595413|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement from Baseline in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement from Baseline in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 study treatment dose.||percentage of participants|||Number
125311|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects||2 weeks||||||
125312|NCT00595361|Secondary|Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects||2 weeks||||||
125313|NCT00595361|Primary|Comparison of the Maximum Percent Fall in FEV1 After Exercise Challenge at the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients||2 weeks|||% fall FEV1||Standard Deviation|Mean
125314|NCT00595335|Secondary|Failure Rate at One Year|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|one year|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 52 weeks.||percentage of participants|||Number
125315|NCT00595335|Secondary|Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|baseline, 6 months after first infusion, 12 months after first infusion|||units on a scale||Inter-Quartile Range|Median
125358|NCT00594685|Secondary|Relationship Between the Presence of the Factor V Leiden Mutation or the Prothrombin 20210 Mutation and the Risk of Thrombosis|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.|||||
125316|NCT00595335|Secondary|Change in Extraocular Motility|"Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object.~The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant)."|baseline, 6 months after first infusion, 12 months after first infusion|Intention to treat analysis||units on a scale||Inter-Quartile Range|Median
125317|NCT00595335|Secondary|Change in Lid Fissure|"The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease.~Improvement was defined as a decrease in lid aperture width by ≥3 mm."|baseline, 6 months after first infusion|Intention to treat analysis||mm||Inter-Quartile Range|Median
125318|NCT00595335|Secondary|Change in Proptosis|Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm.|baseline, 12 months after first infusion|||mm||Standard Deviation|Mean
125319|NCT00595335|Secondary|Change in Disease Severity|Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0–6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is based on the first letter of the defining characteristic of each class, the classification is known as: ‘no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss’ (NOSPECS) ).|baseline, 6 months after first infusion|Intention to treat analysis||participants|||Number
125320|NCT00595335|Secondary|Failure Rate|The failure rate was defined as a composite variable of CAS decrease of < 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.|6 months after first infusion, 12 months after first infusion|Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 24 weeks.||percentage of participants|||Number
125321|NCT00595335|Primary|Change in Clinical Activity Score (CAS)|The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease.|baseline, 6 months after the first infusion|Sample size was computed based on the expected drop of 2.9 and 1.5 points in the CAS score in rituximab and placebo groups. A sample size of 15 in each group will have 80% power to detect a difference in mean values of 1.4 assuming that the common standard deviation is 1.27 using a two group t-test with a 0.050 two-sided significance level.||units on a scale||Standard Deviation|Mean
125322|NCT00595309|Secondary|Geometric Mean Titer||D28, Month 6 and Month 12 after booster||||||
125323|NCT00595309|Secondary|Seroconversion||at D28 and Month 6 after booster||||||
125324|NCT00595309|Secondary|Safety and Adverse Events||up to Month 12 after booster||||||
125325|NCT00595309|Primary|Seroconversion Rate||at Month 12 after booster|Intent-To-Treat Population which includes all subjects entered into the study who received the booster vaccination||percent||95% Confidence Interval|Number
125326|NCT00595270|Secondary|Safety Profile of IC51||study duration||||||
125327|NCT00595270|Secondary|GMT 1month After Booster Doses||1 month||||||
125328|NCT00595270|Secondary|SCR 1 Month After the Booster Doses||1 month||||||
125329|NCT00595270|Secondary|Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination||24 months||||||
125330|NCT00595270|Secondary|Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination||- 24 months||||||
125331|NCT00595270|Secondary|SPR 24 Months After the Primary Vaccination (Observed)|"Persistence of immunogenicity (SPR) at M24 (observed) defined as :~positive (persistent): Subjects~with a non-missing, positive seroconversion at D56 (Study IC51-304), and~who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and~with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and~with a non-missing, SP positive PRNT50 result at Visit 5 (M24)~negative (non-persistent): Subjects~with missing or negative seroconversion at D56 (Study IC51-304), or~who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or~with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or~with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or~with a non-missing, SP negative PRNT50 result at Visit 5 (M24)"|24 months||||||
125332|NCT00595270|Primary|Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination|"Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:~pos. (positive) (persistent): Subjects~with a non-missing, pos. seroconversion at D56 (Study IC51-304) and~without booster at M11 or M23 and~with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and~with non-missing, SP pos. PRNT50 at M24~neg. (negative) (non-persistent): Subjects with~missing or neg. seroconversion at D56 (Study IC51-304) or~booster at M11 or at M23, or~non-missing, SP neg. PRNT50 at M6 or M12 or~missing PRNT50 at both M6 and M12 or~missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24"|- 24 months|ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304||percentage of participants||95% Confidence Interval|Number
125355|NCT00594854|Secondary|Number of Participants With Upper Gastro-intestinal Injury Grade 4 as Measured by Lanza (1991) Score|The degree of upper gastrointestinal (UGI) injury as measured by Lanza scores (1991) during treatment with PN 400 and ARTHROTEC® in a high-risk population. The Lanza (1991) score is based on endoscopic obeservations and rating these, with no damage, petecchiae, erosions and ulcers. On the 1991 scale, a Lanza score of 0 represents normal mucosa (no damage), while a score of 4 indicates 6-10 erosions, and a score of 7 indicates an ulcer.|6 months|||participants|||Number
125333|NCT00595153|Primary|Gene Expression in Airway Secretions and Tissues|The primary outcome measure for this study is the scaled mean value of three gene expression markers of IL-13 in the airway: PERIOSTIN, calcium-activated chloride channel regulator 1 (CLCA1), and plasminogen activator inhibitor-2 (SERPINB2). First, for each of the three interleukin-13 (IL-13) signature genes, the log (base-2) transformed relative expression value for each subject is measured using real-time polymerase chair reaction (PCR) and normalized with the geometric mean of 5 housekeeping genes. Next, these values are centered (by subtracting the mean for that gene) and scaled (by dividing by the standard deviation for that gene) so that each gene makes an equal, assay-independent contribution to the Th2 phenotype. Then, for each subject, the arithmetic mean of the three centered & scaled genes is calculated, producing the “three-gene-mean” metric.|Healthy Control: Visit 2 (at 1 week); Steroid Naive Asthmatics: Visit 2 (at 1 week); Steroid Treated Asthmatics: Visit 5 (at 9 weeks)|"Participants who met inclusion/exclusion requirements and completed all study activities were included in the analysis. Specifically, this included:~1. Having a bronchoscopy with complete PCR on RNA from epithelial brush samples."||Relative gene expression level||Standard Deviation|Mean
125334|NCT00595127|Primary|Incidence & Quality of Engraftment & Hematopoietic Reconstitution|Number of patients who engrafted|8 years|||participants|||Number
125335|NCT00595114|Primary|8-isoprostane Levels as Biochemical Markers for Nonenzymatic Oxidative Stress in Asthma|8-isoprostane levels in sputum|Measured at completion of sample analysis|||pg/ml||Standard Deviation|Mean
125336|NCT00595088|Secondary|Safety|the incidence and severity of adverse events|9 weeks|||percentage of participants|||Number
125337|NCT00595088|Secondary|Ablative Effect on a Marker Tumor|Complete disappearance of marker lesion|9 weeks|||percentage of participants||90% Confidence Interval|Number
125338|NCT00595088|Secondary|Time to Tumor Recurrence|The Time to Tumor Recurrence is defined as the interval between the date of the final tumor resection before the start of study treatments to the date when the cystoscopy was performed in which it was confirmed by histopathology that any suspicious lesions that were observed, were TCC of the bladder with the exception of the continued presence of the marker tumor at Week 9|46 Weeks|||months||Full Range|Median
125339|NCT00595088|Primary|Complete Tumor Response Defined as the Absence of New Tumors|Tumor response evaluated at week 9 (range 8-10 weeks) during the first post induction course treatment cystoscopy or TUR of suspiciaous lesions|9 Weeks|All patients who met the study inclusion and exclusion criteria; received all 6 of the induction course intravesical administrations of the investigational product; and had a follow-up cystoscopy during Weeks 8 to 10 and biopsy or TUR of suspicious lesions||percentage of participants||90% Confidence Interval|Number
125340|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Number of Lapses|Number of trials per test battery with a reaction time >0.5 seconds (higher values indicate worse outcome)|8 hours|All participants completing both crossover periods||lapses||Standard Deviation|Mean
125341|NCT00595075|Other Pre-specified|Psychomotor Vigilance Task - Median Reaction Time|Visual-motor reaction time in which participants hit a button on a response box as fast as possible in response to a visual target (lower values indicate better outcome)|8 hours|All participants completing both crossover periods||seconds||Standard Deviation|Mean
125342|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Drowsiness Test|EEG spectral analysis of 5.5-9.0 Hz frequency activity (theta low-frequency alpha), with higher activity indicating increased drowsiness and worse outcome|71 minutes|All participants completing both crossover periods||microvolts^2/Hz||Standard Deviation|Mean
125343|NCT00595075|Other Pre-specified|Post Nap Assessment - Digit Symbol Substitution Test (Correct Answers)|A cognitive throughput task consisting of matching symbols to numerical keys; higher numbers indicate a better score|71 minutes|All participants that completed both crossover periods||correct answers||Standard Deviation|Mean
125344|NCT00595075|Other Pre-specified|Post Nap Assessment - Karolinska Sleepiness Scale|numerical scale of increasing sleepiness from 1-9 (higher values indicate worse outcome)|71 minutes|All participants that completed both crossover periods||units on a scale||Standard Deviation|Mean
125345|NCT00595075|Other Pre-specified|Post-nap Assessment - Visual Analog Scale|numerical scale of increasing alertness from 0-100 (higher values are better outcome)|71 minutes|All participants that completed both crossover periods||units on a scale||Standard Deviation|Mean
125346|NCT00595075|Primary|Sleep Efficiency|total sleep time/time in bed * 100% (higher values indicate better outcome)|2 hours|All participants that completed both crossover periods||percent||Standard Deviation|Mean
125347|NCT00594958|Secondary|SCR for Anti-JEC Neutralizing Antibody Titer||day 56||||||
125348|NCT00594958|Secondary|Safety|Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability|study duration||||||
125349|NCT00594958|Primary|GMT for Anti-JEV Neutralizing Antibody|Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.|day 56|Per Protocol Population (observed values)||GMT||95% Confidence Interval|Geometric Mean
125350|NCT00594945|Primary|Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).|Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.|Change from baseline to treatment day|||percentage of baseline||Standard Deviation|Mean
125351|NCT00594906|Primary|Healing of a Fracture From a Low Energy Fall|Callus formation at the fracture site as defined by a CT scan to determine healing (early/beginning callus formation) or healed (complete callus formation)|Measured at 16 weeks|||participants|||Number
125352|NCT00594880|Secondary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|24 weeks|percent of consenting eligible participants (n=8) with VL < 400 at week 24 of treatment||percentage of eligible participants|||Number
125353|NCT00594880|Secondary|HIV Viral Load < 48 Copies/ml|% of individuals maintaining VL < 48 copies/ml while on pegylated interferon alpha-2a treatment without ART|12 weeks|% of subjects maintaining VL < 48 copies/ml after 12 weeks of treatment||percentage of participants|||Number
125354|NCT00594880|Primary|HIV Viral Load < 400 Copies/ml|% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)|12 weeks|excluded 2 withdrawal of consent and 1 lost to follow-up||percentage of participants|||Number
125359|NCT00594685|Post-Hoc|Time to First Asymptomatic or Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|Since two versions of the data collection form were used in this study, and only the revised version contained information on whether the event was asymptomatic or symptomatic, a post-hoc analysis was performed which included all thromboses, whether symptomatic, asymptomatic, or of unknown type. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|||Days||Standard Error|Mean
125360|NCT00594685|Secondary|Relationship Between PF4-heparin ELISA Test, Serotonin-release Assay, and D-dimer Test Results and Thromboembolism|Analysis not performed since central laboratory tests were not done.|Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT|Analysis not performed since central laboratory tests were not done.|||||
125361|NCT00594685|Secondary|Relationship Between the Platelet Factor 4 (PF4)-Heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) Test, the Serotonin-release Assay, and D-dimer Test Results|Analysis not performed since central laboratory tests were not done.|Measured at Day 1|Analysis not performed since central laboratory tests were not done.|||||
125362|NCT00594685|Secondary|Length of Hospital Stay (With Deaths Not Censored)|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were not censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.||Days||Standard Error|Mean
125363|NCT00594685|Secondary|Length of Hospital Stay|The length of time between the date of HIT diagnosis and first hospital discharge was calculated. Subjects were censored at death. Survival analysis was used.|Measured upon hospital discharge|Two subjects were known to be readmitted to the hospital after initially being discharged.||Days||Standard Error|Mean
125364|NCT00594685|Secondary|Number of Days That Medications Were Given to Participants at Participating Institutions|Per the protocol, descriptive statistics on the types and durations of therapeutic approaches used will be presented.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|||Days medication was given||Full Range|Median
125365|NCT00594685|Secondary|Time to Platelet Count Recovery|The time to platelet recovery was defined as the time from the nadir platelet count observed in the five days after the positive HIT test was sent to observing a platelet count of 100K or greater. Survival analysis was used.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject's nadir platelet count was > 100K, so that subject is not included in the analysis.||Days||Standard Error|Mean
125366|NCT00594685|Secondary|Time Until Death From All Causes|The time until death from all causes, in days, was determined using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|One subject was censored at the time that the study was terminated.||Days||Standard Error|Mean
125367|NCT00594685|Secondary|The Time to First Bleeding Event With Current Therapies for Isolated HIT|The time to first bleeding event was analyzed using survival analysis.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|||Days||Standard Error|Mean
125368|NCT00594685|Secondary|The Number of Participants With Incidental Arterial and Venous Thromboembolism (i.e., a Clot Diagnosed by Radiographic Tests Done for Reasons Other Than to Diagnose or Rule Out a Thromboembolic Event)|There were two versions of the data collection form used in this study, and only the revised form contained information on whether the event was incidental.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was incidental. These subjects were censored in the analysis.||Participants|||Number
125369|NCT00594685|Secondary|The Number of Participants With Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT|There were two versions of the data collection form used in this study, and only the revised version collected information on whether the event was symptomatic.|Measured within 35 days (+/- 7) after the diagnosis of isolated HIT|Two subjects did not have information on whether the event was symptomatic or asymptomatic. These two subjects were censored in the analysis.||Participants|||Number
125370|NCT00594685|Secondary|The Percentage of Participants With Asymptomatic Thrombosis 4 Weeks After the Diagnosis of Isolated HIT, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis 4 weeks after the diagnosis of isolated HIT, determined by four-limb ultrasound, and 95% exact binomial confidence interval.|Measured at Day 35 (+/- 7days)|Four subjects had missing data for this endpoint (no ultrasound performed on end-of-study date) and are not included in this analysis.||Percentage of participants||95% Confidence Interval|Mean
125371|NCT00594685|Primary|The Percentage of Participants With Asymptomatic Thrombosis at the Time Isolated Heparin-Induced Thrombocytopenia (HIT) is Diagnosed, Determined by Four-limb Ultrasound|The percentage of participants with asymptomatic thrombosis at the time isolated HIT is diagnosed as determined by four-limb ultrasound.|Measured at Day 1|||Percentage of participants||95% Confidence Interval|Mean
125372|NCT00594659|Primary|Point Prevalence Abstinence Post Treatment|Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).|9 months (from the end of treatment to 9 months post-treatment).|Intent to Treat||pecentage of participants abstinent|||Number
125373|NCT00594659|Primary|Consecutive Weeks of Marijuana Abstinence|Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.|From the start of treatment through the end of the active treatment period, i.e., 12 weeks.|Intent to Treat||consecutive weeks of abstinence||Standard Deviation|Mean
125374|NCT00594646|Primary|Number of HIV-1 Infected Participants|Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected|90 days|Participants evaluable at 3 months (90 days) after treatment initiation||participants|||Number
125375|NCT00594646|Primary|Medication Regimen Completion Rates|Pill counts performed at 14 and 28 days|28 days|||participants|||Number
125376|NCT00594568|Secondary|Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
125377|NCT00594568|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
125378|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug|RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
125379|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity. LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
125380|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
125381|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
125382|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug|Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains. Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.|||||
125383|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125394|NCT00594568|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
125384|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125385|NCT00594568|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||hospitalizations/participant||Standard Error|Least Squares Mean
125386|NCT00594568|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver’s impression of participant’s overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125387|NCT00594568|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125388|NCT00594568|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125389|NCT00594568|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125390|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125391|NCT00594568|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125392|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of volume of distribution.||liter (L)||Geometric Coefficient of Variation|Geometric Mean
125393|NCT00594568|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of clearance.||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
125395|NCT00594568|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||ratio||Standard Error|Least Squares Mean
125396|NCT00594568|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
125397|NCT00594568|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||ratio||Standard Error|Least Squares Mean
125398|NCT00594568|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
125399|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125400|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125401|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug|ADAS‑Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125402|NCT00594568|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks|ADAS‑Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.||units on a scale||Standard Error|Least Squares Mean
125403|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol ER During the DB Treatment Period.|Average total daily dose (TDD) of tapentadol ER during the double-blind treatment period.|14 days for each treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||mg||Standard Deviation|Mean
125404|NCT00594516|Secondary|Total Daily Dose (TDD) of Tapentadol IR During the Double-blind Treatment Period|Average total daily dose (TDD) of tapentadol IR during the double blind treatment period|14-day for each DB treatment period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||mg||Standard Deviation|Mean
125405|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol ER Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||participants|||Number
125406|NCT00594516|Secondary|The Number of Patients Requiring Rescue Medication During the DB Tapentadol IR Treatment||14 days for each cross-over period|DB safety set defined as randomized subjects who took at least one dose of study drug during the DB treatment period.||participants|||Number
125432|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Second Treatment||immediately after second treatment|Safety||percentage of participants|||Number
125407|NCT00594516|Primary|The Difference in the Mean Average Pain Intensity Score on an 11-point Numerical Rating Scale (NRS) During the Last 3 Days of Each Double-blind Treatment Period. (Difference Between Two DB Randomization Treatment Sequences)|"For this twice daily pain assessment, the subjects were to indicate the level of average pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|14 days for each cross-over period|Per-protocol set defined as the number of randomized subjects who took at least one dose of study drug during the DB treatment period, and who met additional criteria which were identified prior to unblinding.||Units on a scale||95% Confidence Interval|Least Squares Mean
125408|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient.|Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson’s Disease were well controlled Item 3: I felt safe with the Parkinson patch|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)||Score on scale||Standard Deviation|Mean
125409|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option|2 weeks after surgery|Full Analysis Set (Subjects having valid data for all three feasibility assessments)||Score on scale||Standard Deviation|Mean
125410|NCT00594464|Secondary|Plasma Concentration of Rotigotine After Use.||24 hours|Pharmacokinetic Set (Subjects for whom a blood sample for determination of the plasma concentration of rotigotine was drawn and a valid determination of the plasma concentration could be done)||ng/ml||Standard Deviation|Mean
125411|NCT00594464|Primary|Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist.|Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn’t time-consuming Item 4: Patch is a considerable option|After subject wakes up from general anesthesia|Full Analysis Set (Subjects having valid data for all three feasibility assessments)||Score on scale||Standard Deviation|Mean
125412|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||12 weeks after last treatment|Safety||percentage of participants|||Number
125413|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||12 weeks|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||lesions||95% Confidence Interval|Least Squares Mean
125414|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||percentage of participants|||Number
125415|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||6 weeks after last treatment|Safety||percentage of participants|||Number
125416|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 weeks after first treatment|Safety||percentage of participants|||Number
125417|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment||2 weeks after last treatment|Safety||percentage of participants|||Number
125418|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment||2 days after first treatment|Safety||percentage of participants|||Number
125419|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||12 weeks after last treatment|Safety||percentage of participants|||Number
125420|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||6 weeks after last treatment|Safety||percentage of participants|||Number
125421|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment||2 weeks after last treatment|Safety||percentage of participants|||Number
125422|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 weeks after first treatment|Safety||percentage of participants|||Number
125423|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment||2 days after treatment|Safety||percentage of participants|||Number
125424|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Fourth Treatment||immediately after fourth treatment|Safety||percentage of participants|||Number
125425|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Third Treatment||immediately after third treatment|Safety||percentage of participants|||Number
125426|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After Second Treatment||immediately after second treatment|Safety||percentage of participants|||Number
125427|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 7 Days After First Treatment||7 days after first treatment|Safety||percentage of participants|||Number
125428|NCT00594425|Secondary|Proportion of Patients With Severe Erythema 2 Days After First Treatment||2 days after first treatment|Safety||percentage of participants|||Number
125429|NCT00594425|Secondary|Proportion of Patients With Severe Erythema After First Treatment||immediately after first treatment|Safety||percentage of participants|||Number
125430|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment||immediately after fourth treatment|Safety||percentage of participants|||Number
125431|NCT00594425|Secondary|Proportion of Patients With Mild and Moderate Erythema After Third Treatment||immediately after third treatment|Safety||percentage of participants|||Number
125438|NCT00594425|Secondary|Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.|Measure was assessed on a Visual Analogue Scale from 0 to 10 cm|immediately after illumination-first treatment|Safety||cm||Full Range|Median
125439|NCT00594425|Secondary|The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment||12 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||percentage of participants|||Number
125440|NCT00594425|Secondary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Precentage of participants|||Number
125441|NCT00594425|Secondary|Percent Reduction in Total Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
125442|NCT00594425|Primary|Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts||12 weeks after last treatment|ITT population||lesions||95% Confidence Interval|Least Squares Mean
125443|NCT00594425|Primary|Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment||12 weeks after last treatment|ITT population||Percentage of participants||95% Confidence Interval|Number
125444|NCT00594425|Secondary|Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
125445|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||6 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
125446|NCT00594425|Secondary|Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline||3 weeks after last treatment|PP population: excludes all patients with major protocol deviations (consists of the following types of events: Baseline inflammatory lesion count other than 20-100, received less that 4 treatments, primary efficacy criteria missing at week 12, insufficient primary efficacy follow up time, prohibited concomitant medication (retinoid).||Percentage change||Full Range|Median
125447|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.||minutes per week||Standard Deviation|Mean
125448|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|3 months|||minutes per week||Standard Deviation|Mean
125449|NCT00594399|Secondary|Physical Activity, Endurance|Physical activity, endurance/aerobic activities by self-report from the CHAMPS questionnaire of physical activity for older adults.|Baseline|||minutes per week||Standard Deviation|Mean
125450|NCT00594399|Primary|12 Month Fasting Glucose||12 Months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.||mg/dl||Standard Deviation|Mean
125451|NCT00594399|Primary|3 Month Fasting Glucose||3 months|||mg/dl||Standard Deviation|Mean
125452|NCT00594399|Primary|Fasting Glucose||Baseline|||mg/dl||Standard Deviation|Mean
125453|NCT00594399|Primary|12 Month Fasting Insulin||12 months|All of the primary analyses reported here were based upon comparisons to physical activity counseling (Arm 1) versus usual care (Arm 2). No subgroup analyses within the intervention arm were conducted for this primary outcome report. The decision to analyze and report the data in Arm 1 in aggregate was done apriori during design of the study.||uIU/ml||Standard Deviation|Mean
125454|NCT00594399|Primary|3 Month Fasting Insulin||3 month|||uIU/ml||Standard Deviation|Mean
125455|NCT00594399|Primary|Fasting Insulin|Fasting Insulin analyzed at VA central laboratory by technicians not affiliated with study. Participants were instructed to refrain from eating or drinking anything except water and medications past midnight. A reminder call was placed the night before the scheduled appointment and fasting was verified by study personnel before appointed blood draws.|Baseline|||uIU/ml||Standard Deviation|Mean
125456|NCT00594386|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
125457|NCT00594386|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).||Subjects|||Number
125458|NCT00594386|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|6 years|Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).||Subjects|||Number
125459|NCT00594308|Secondary|Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.|Number of patients who died due to transplant related toxicities|up to 2 years after stem cell transplant|Intent To Treat: All patients that received study drug||participants|||Number
125460|NCT00594308|Secondary|Time to Resolution of Cytopenias: Platelet Transfusion Independence|Average number of days per patient for resolution of cytopenias.|From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion)|IIT: All patients that received study drug.||days per patient||Standard Deviation|Mean
125461|NCT00594308|Secondary|Number of Days for Absolute Neutrophil Count to Recover|Average number of day per patient for absolute neutrophil count to recover(> 500/mm3 for 3 consecutive days).|From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion)|ITT: All patient that received study drug||days per patient||Standard Deviation|Mean
125462|NCT00594308|Secondary|Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).||until 30 days after stem cell transplant|ITT population. All patient that received study drug||participants|||Number
125463|NCT00594308|Primary|Number of Patients With Acute Grade II-IV GVHD|Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.|until 30 days after stem cell transplant|All patient that received study drug||participants|||Number
125464|NCT00594256|Secondary|Slow Wave Sleep Minutes|Overnight sleep study: Subjects will undergo polysomnography four times during this study, on consecutive nights during the observation week and on consecutive nights at the end. Polysomnography will be performed in a modified seclusion room on the in patient unit. The first of the consecutive nights will be used for adaptation to the study conditions. Sleep was recorded between lights off (10 pm) and lights on (at 6:45 am). We aim for conditions for falling asleep as comfortable as possible under the experimental condition.|1 month|4 pre post||minutes||Standard Deviation|Mean
125465|NCT00594256|Secondary|MATRICS Neurocognitive Battery Composite|This is a series of neurocognitive tests developed by the National Institute of Mental Health to evaluate medications targeting cognition in an efficient and reliable manner. It will be modified by the deletion of the social competence domain. The six domains include speed of processing, attention/vigilance, working memory, verbal learning, visual learning and reasoning/problem solving. The primary outcome will be the mean T-score (mean of six domains).|1 month|||Composite T-score||Standard Deviation|Mean
125466|NCT00594256|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Factor|The PANSS Negative factor is a 7-item rating scale widely used in the assessment of schizophrenia. Range is 7-49 with higher scores worse|1 month|Paired t test of baseline and final values||mean decrease in negative subscale||Standard Deviation|Mean
125467|NCT00594256|Primary|Epworth Sleepiness Scale|Designed to measure daytime sleepiness. 8 items rated 0-3, with higher scores associated with a greater daytime sleepiness. overall score rated 0-24, with scores greater than 10 indicating significant daytime sleepiness.|1 month|||global score||Standard Deviation|Mean
125468|NCT00594256|Primary|Pittsburgh Sleep Quality Index|This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven “component” scores, each of which has a range of O-3 points. The seven component scores are then added to yield one “global” score, with a range of O-21 points, “0” indicating no difficulty and “21” indicating severe difficulties in all areas.|1 month|ITT||global score||Standard Deviation|Mean
125469|NCT00594230|Secondary|Safety and Tolerability of LBH589 in Patients With Relapsed/Refractory MDS|NOTE: Study terminated early, no results are available for this endpoint|24 months||||||
125470|NCT00594230|Secondary|Median Overall Survival|"The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death~NOTE: Study terminated early, no results are available for this endpoint"|24 months on-study, patients followed every 3 months in follow-up||||||
125471|NCT00594230|Secondary|Median Time to Treatment Failure|"Time to treatment failure is defined as measuring the time between cycle 1 day 1 to discontinuation for any reason.~NOTE: Study terminated early, no results are available for this endpoint"|24 months||||||
125472|NCT00594230|Secondary|Duration of Response|"Duration of response is defined as the time from when objective response is realized until time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Objective Response = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study||||||
125473|NCT00594230|Secondary|Hematologic Improvement, Including Transfusion Independence|"Hematologic measures will include total WBC and platelets~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study||||||
125489|NCT00594100|Primary|Composite Major Adverse Event (MAE) Rate|Number of participants with one or more Major Adverse Event (death, stroke, myocardial infarction, and/or transient ischemic attack (TIA)) through the 30-day follow-up (non-hierarchical; MAE adjudicated by independent Clinical Events Committee)|Treatment through 30-day visit window|All primary endpoint evaluable subjects||participants|||Number
125474|NCT00594230|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~NOTE: Study terminated early, no results are available for this endpoint"|Every 8 weeks up to 24 months on-study, every 3 months in follow-up until progression of disease||||||
125475|NCT00594230|Primary|Overall Response Rate (CR, Marrow CR + PR) of LBH in Patients With Relapsed or Refractory MDS.|Overall response rate (ORR) is defined by the modified International Working Group (IWG) Response Criteria for MDS. In the marrow, Complete Response (CR) is <= 5% blasts present with normal maturation of all cell lines. In peripheral blood, CR is defined as hemoglobin >= 11 g/dL, ANC >= 1000/mL, and platelets >= 100,000 with 0% blasts present. Partial Response (PR) is defined the same as CR with blasts decreased by >= 50% and >= 5% blasts in the marrow.|Every 8 weeks up to 24 months on-study.|All evaluable patients assessed for response prior to early study termination - one patient in each arm was not evaluable due to coming off-study prior to assessment||participants|||Number
125476|NCT00594204|Primary|Number of Participants With 4-week Continuous Abstinence|The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits|Weeks 9 through 12|Intent-to-treat (ITT)||participants|||Number
125477|NCT00594204|Secondary|Number of Participants With Seven-day Point Prevalence of Abstinence|Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day|Week 12 and 24|ITT||participants|||Number
125478|NCT00594204|Secondary|Number of Participants With Continuous Abstinence|The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm|Weeks 9 through 24|ITT||participants|||Number
125479|NCT00594178|Secondary|Bone Density Via Dual-Energy X-ray Absortiometry (DEXA) Scan|Bone mineral density was measured with Dual-Energy X-ray Absortiometry (DEXA) scan pre and post, three month exercise protocol on a passive motorized exercise bicycle.|baseline and 3 months Post-exercise|||grams/cm^2||Standard Deviation|Mean
125480|NCT00594178|Primary|Muscle Mass Via Dual-Energy X-ray Absortiometry (DEXA)Scan Data|Lean muscle mass was measured with Dual-Energy X-ray Absortiometry (DEXA) scan, which uses low dose radiation to assess bone density and soft tissue density. pre and post, three month exercise protocol on a passivie motorized exercise bicycle.|baseline and 3 months|analysis per protocol||grams||Standard Deviation|Mean
125481|NCT00594165|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person’s level of daytime sleepiness.|Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set. Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
125482|NCT00594165|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.||subjects|||Number
125483|NCT00594165|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|7 years|Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.||Subjects|||Number
125484|NCT00594100|Secondary|Patency at 30 Days|Number of participants with less than 50% restenosis as determined by carotid duplex ultrasound core laboratory at 30 days post-procedure.|Treatment through 30-day visit window|Subjects with successful stent placement and ultrasound evaluation at 30-day follow-up evaluation.||participants|||Number
125485|NCT00594100|Secondary|Clinical Success|Number of participants with Flow Reversal System and Stent Success in the absence of death, emergency endarterectomy, repeat percutaneous transluminal angioplasty (PTA)/thrombolysis of the target vessel, stroke, or myocardial infarction (MI), as determined by the Clinical Events Committee (CEC).|24-48 Hours Post-Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis||participants|||Number
125486|NCT00594100|Secondary|Stent Success|Number of participants where the FDA-approved stent was successfully delivered, deployed,and delivery system removed with an attainment of < 50% residual stenosis following stent placement, as assessed by the angiographic core laboratory.|Procedure|All enrolled subjects with post procedure angiographic assessment of lesion stenosis||participants|||Number
125487|NCT00594100|Secondary|Flow Reversal System Success|Number of participants where the GORE Flow Reversal System was delivered, placed, reverse flow was established, and the balloon sheath and wire retrieved as outlined in the Instructions for Use without causing any adverse events during the procedure.|Procedure|||participants|||Number
125488|NCT00594100|Secondary|Flow Reversal System Technical Success|Number of participants with Technical Success using the GORE Flow Reversal System (system deployed and utilized during stenting procedure)|Procedure|All enrolled subjects||participants|||Number
125490|NCT00594035|Primary|Watertight Dural Closure|Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.|Intra-Operative|||Participants|||Number
125491|NCT00594022|Secondary|Scored Sleep Onset Latency (SOL on PSG)||Treatment Night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
125492|NCT00594022|Secondary|Total Sleep Time (TST) in the First Hour After Lights Out||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
125493|NCT00594022|Secondary|Total Sleep Time (TST) in the First 2 Hours After Lights Out||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
125494|NCT00594022|Secondary|Subjective Sleep Onset Latency (SOL)||Treatment night|It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.||minutes||Standard Deviation|Mean
125495|NCT00594022|Primary|Latency to Persistent Sleep (LPS)||Treatment Night|Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group.||minutes||Standard Deviation|Mean
125496|NCT00593957|Secondary|Mean SSI Score for Total Subjects at Baseline and 6 Months|Analysis of Difference in Mean Screen for Social Interaction (SSI) Score between 0-6 months for total sample (n=19).|0-6 months|19 subjects (total sample) for whom complete data was available||scores on a scale||Standard Deviation|Mean
125497|NCT00593957|Secondary|Difference in SSI Mean Score at Six Months Compared to Baseline for Each Treatment Arm.|The Screen for Social Interaction (SSI) is a 54-item parent/caregiver-report screening instrument that emphasizes reciprocal social interaction including joint attention skills. The items are positive (prosocial) and are scored on a four-point frequency scale (child displays the behavior “almost never” = 0 to “almost all the time” = 3). Thus lower scores reflect a slower or delayed development, and higher scores reflect more normative development. SSI total scores range from 0-162. There are no subscales. Difference in Screen for Social Interaction (SSI) mean scores between baseline and 6 months post-treatment for each treatment arm are reported.|Initial and 6 month followup|Those who provided complete information only were included. Others did not provide adequate or complete information for analysis.||scores on a scale||Standard Deviation|Mean
125498|NCT00593957|Secondary|Improvement in Receptive Language as Measured by the Mullen Scale.|The Mullen Receptive language scale pre and 6 months post DM, measured as a change in the mean score of language, by age in months.|Change in mean between Initial and 6-month follow-up|25/35 enrolled participants completed the receptive language scale of the Mullen and underwent the analysis.||age in months||Standard Deviation|Mean
125499|NCT00593957|Primary|Difference in EEG Spike Counts at Six Months Compared to Baseline for Each Treatment Arm.|Difference in EEG spike count means pre and 6 months post-treatment in each of three treatment groups.|Initial and 6-month post-treatment|33/35 participants who completed the protocol with two epochs of 5 mins of non-Rapid eye movement (REM)sleep during which spikes could be counted pre and post DM intake.||EEG spike counts per minute||Standard Deviation|Mean
125500|NCT00593918|Primary|Percentage of Participants With Detected Nasal Interferon (IL)-2 Cytokine Expression|IL-2 measured from nasal lavage samples by Luminex multiplex assay|1-5 days during acute illness (not after day 5 of illness)|||Percentage of Participants|||Number
125501|NCT00593918|Primary|Nasal Interferon (IFN)-a2|Interferon a2 was measured from nasal lavage samples by Luminex multiplex assay.|1-5 days during acute illness (not after day 5 of illness)|Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.||pg/ml||Standard Deviation|Mean
125502|NCT00593866|Secondary|The Percentage of Participants Free From Local Progression at 2 Years||2 Years|||percentage of participants||95% Confidence Interval|Number
125503|NCT00593866|Primary|The Maximum Tolerated Radiation Dose|The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.|13 weeks post radiation|||Gray (Gy)|||Number
125504|NCT00593827|Secondary|Incidence of All Grades of Peripheral Neuropathy|All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.|Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|Safety population.||Participants|||Number
125505|NCT00593827|Other Pre-specified|Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).|"ITT population: Participants randomized on the study (eligible and ineligible). AEs, AEs leading to death and GR 3-4 AEs: Safety population-Participants who received atleast 1 dose of study drug).~AEs leading to death: For 4 participants in Arm 1 and both participants in Arm 2, the reported AE term was disease progression."||Participants|||Number
125506|NCT00593827|Secondary|Duration of Response|Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.|From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)|ITT population with CR or PR.||Months||95% Confidence Interval|Median
125507|NCT00593827|Secondary|Time to Response|"Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.~CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD."|From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)|ITT population with CR or PR.||Months||Full Range|Median
125508|NCT00593827|Secondary|Overall Survival (OS)|"Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.~Survival time (months) = (End date – date of randomization + 1)/30.4375"|From the date of randomization to date of death (maximum participant OS of 26.3 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).||Months||95% Confidence Interval|Median
125509|NCT00593827|Secondary|Best Response as Assessed With RECIST|Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population: All treated participants with CR, PR, SD, PD, or NE response and who had received at least 1 dose of study drug.||Percentage of Participants||95% Confidence Interval|Number
125510|NCT00593827|Secondary|Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]|"ORR is defined as the proportion of responders (complete response [CR] + partial response [PR] in participants with measurable disease) in that arm among all randomized participants.~CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.~Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], X-ray) or as ≥10 mm with spiral CT scan."|Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)|Evaluable population-All treated participants with CR, PR, stable disease (SD), progressive disease (PD), or nonevaluable (NE) response and who had received at least 1 dose of study drug. Please refer outcome measure 4 for explanation of SD, PD, and NE.||Percentage of Participants||95% Confidence Interval|Number
125511|NCT00593827|Secondary|Median Progression Free Survival|PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date – date of randomization + 1)/30.4375.|From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)|ITT population: Participants who were randomized on the study (eligible and ineligible).||Months||95% Confidence Interval|Median
125512|NCT00593827|Primary|Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months|PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.|From the date of randomization to 6-months on study|ITT population: Participants who were randomized on the study (eligible and ineligible).||Percentage of Participants||95% Confidence Interval|Number
125513|NCT00593814|Secondary|Device Efficacy Events||2 years||||||
125514|NCT00593814|Primary|Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure||2 years|||participants|||Number
125515|NCT00593736|Secondary|Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period.|Average Cmax calculated as the average of three highest Cmax observations within the sampling period.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||μg/dL||Standard Error|Least Squares Mean
125516|NCT00593736|Secondary|The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours|Area under the concentration-time curve is a measure of total drug exposure.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||μg/dL/hour||Standard Error|Least Squares Mean
125517|NCT00593736|Secondary|The Total Duration of Secretion of Melatonin|The total duration of time from Dim Light Melatonin Secretion Onset to Dim Light Melatonin Secretion Offset.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||minutes||Standard Error|Least Squares Mean
125518|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Offset|Dim Light Melatonin Secretion Offset is defined as the first time of the morning (on a 24-hour clock) when the melatonin drops to below 3 pg/mL with a negative slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125659|NCT00593606|Primary|Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
125519|NCT00593736|Secondary|The Time of Dim Light Melatonin Secretion Onset|Linear Dim Light Melatonin Secretion Onset is defined as the first time of the evening (on a 24-hour clock) when the melatonin level rises above 3.0 pg/ml with a positive slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Day 15|The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125520|NCT00593736|Secondary|Visual Analogue Scale for Feelings|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value:0 mm.. Best Value:100 mm.. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
125521|NCT00593736|Secondary|Visual Analogue Scale for Mood|Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value: 0 mm. Best Value: 100 mm. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||Units on a scale||Standard Error|Least Squares Mean
125522|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed|After 16 words were read to a subject, a subject waited 1 minute and then was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings’ tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||score||Standard Error|Least Squares Mean
125523|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate|After 16 words were read to a subject, a subject was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings’ tests was calculated.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||score||Standard Error|Least Squares Mean
125524|NCT00593736|Secondary|Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test|The number of correct digit-for-number substitutions on a Digit Symbol Substitution Test in the 90-second period was recorded to assess psychomotor and cognitive function. The score was the average of 2 mornings' tests. Worst Value: 0. Best Value: No Limit.|Day 15|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||Scores on a scale||Standard Error|Least Squares Mean
125525|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your level of alertness this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125526|NCT00593736|Secondary|Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your level of alertness this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125527|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your ability to concentrate this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125528|NCT00593736|Secondary|Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe your ability to concentrate this morning?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125529|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)|The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, “How easy was it for you to wake or get up in the morning when on a school or working night?” was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125543|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 13-14)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125692|NCT00593450|Secondary|Total Thickness at Fovea||at 1 Year|||μm||Standard Deviation|Mean
125530|NCT00593736|Secondary|Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)|The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, “How easy was it for you to wake or get up in the morning when on a school or working night?” was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125531|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “What time did you try to go to sleep last night?” Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125532|NCT00593736|Secondary|Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “What time did you try to go to sleep last night?” Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125533|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe the quality of your sleep last night?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125534|NCT00593736|Secondary|Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How would you describe the quality of your sleep last night?” Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
125535|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, how many times do you think you woke up?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
125536|NCT00593736|Secondary|Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, how many times do you think you woke up?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
125537|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, what is the total time you think you were awake?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125538|NCT00593736|Secondary|Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “Did you wake up during the night? If “yes”, what is the total time you think you were awake?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125539|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125540|NCT00593736|Secondary|Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125541|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14)|Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125542|NCT00593736|Secondary|Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7)|Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125693|NCT00593450|Secondary|Average Cost of Drug/Patient||at 1 Year|||US dollars per patient||Standard Deviation|Mean
125544|NCT00593736|Secondary|Wake Time Measured by Actigraphy (Nights 6-7)|Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125545|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 13-14)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125546|NCT00593736|Secondary|Sleep Time Measured by Actigraphy (Nights 6-7)|Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125547|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 13-14)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125548|NCT00593736|Secondary|Sleep Latency Measured by Actigraphy (Nights 6-7)|The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125549|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 13-14)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||wake bouts||Standard Error|Least Squares Mean
125550|NCT00593736|Secondary|Wake Bouts Measured by Actigraphy (Nights 6-7)|The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||wake bouts||Standard Error|Least Squares Mean
125551|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125552|NCT00593736|Secondary|Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7)|Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125553|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 13-14)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
125554|NCT00593736|Secondary|Sleep Efficiency Measured by Actigraphy (Nights 6-7)|Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
125555|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 13-14)|Total sleep time pertains to the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125556|NCT00593736|Secondary|Total Sleep Time Measured by Actigraphy (Nights 6-7)|Total sleep time calculated using the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125557|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125615|NCT00593606|Primary|Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set||participants|||Number
125694|NCT00593450|Secondary|Number of Treatments|Cumulative over the 1 year of trial|1 Year|||Number of Treatments||Standard Error|Mean
125558|NCT00593736|Secondary|Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125559|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125560|NCT00593736|Secondary|Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||hours on a 24-hour clock||Standard Error|Least Squares Mean
125561|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125562|NCT00593736|Secondary|Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125563|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
125564|NCT00593736|Secondary|Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||number of awakenings||Standard Error|Least Squares Mean
125565|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125566|NCT00593736|Secondary|Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The number of wake minutes after the onset of persistent sleep prior to the end of recording.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125567|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
125568|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
125569|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
125570|NCT00593736|Secondary|Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)|The total sleep time divided by time-in-bed, multiplied by 100.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||percentage of time asleep||Standard Error|Least Squares Mean
125571|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep.|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125572|NCT00593736|Secondary|Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep.|Nights 6-7|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125573|NCT00593736|Secondary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 13-14|Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125616|NCT00593606|Primary|Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment||Baseline, 28 days|Safety Set||participants|||Number
125617|NCT00593606|Primary|Completion of Trial From Baseline to End of Treatment||Baseline, 28 days|Safety Set||participants|||Number
125574|NCT00593736|Primary|Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)|The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).|Nights 6-7|Analysis was conducted on the full analysis set (FAS), which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.||minutes||Standard Error|Least Squares Mean
125575|NCT00593684|Secondary|Infection Rate|Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days.|infection per 1,000 Line Days|||Infection per 1,000 line days|||Number
125576|NCT00593684|Primary|Serum Silver Concentrate at 28 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|28 Days from enrollment|two subjects died in the treatment group; one subject died in the control group||ng ml -1||Standard Deviation|Mean
125577|NCT00593684|Primary|Serum Silver Concentration at 7 Days|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|7 Days from enrollment|One subject in each group died||ng ml -1||Standard Deviation|Mean
125578|NCT00593684|Primary|Serum Silver Concentration at 1 Day|Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as <15 ng ml -1 with standard Mayo Clinic reference technique.|1 Day (first 24 hours from enrollment)|Study design included intent-to-treat for data collection and intention to stop if signs of toxicities or adverse effects were noted.||ng ml -1||Standard Deviation|Mean
125579|NCT00593645|Secondary|Median Time to Progression|Time to progression is defined as the length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body.|5 years from time of restaging|Of the four surviving patients, three relapsed. One patient remained in remission on day +120.||days||Full Range|Median
125580|NCT00593645|Secondary|Use Conventional STR-PCR Method for Monitoring Engraftment|Includes assessment of mixed chimerism in the whole blood, myeloid cells, T cells, and B cells.|Up to 1 year after transplant|This outcome was not analyzed specifically as the conventional STR-PCR method was used for monitoring engraftment.|||||
125581|NCT00593645|Secondary|Rate of Chronic Graft-versus-host Disease (GVHD)||100 days-1 year after transplant|None of the participants had chronic graft-versus-host disease (GVHD). 3 participants expired prior to day 100.||percentage of participants|||Number
125582|NCT00593645|Secondary|Rate of Acute Graft-versus-host Disease (GVHD)|Acute GVHD occurs within 100 days of transplant.|Up to 100 days after transplant|||percentage of participants|||Number
125583|NCT00593645|Secondary|Disease-free Survival|Disease-free survival is defined as the length of time after treatment ends that the participant survives without any signs or symptoms of that cancer.|5 years from time of restaging|None of the patients analyzed survived without any signs or symptoms of that cancer.||participants|||Number
125584|NCT00593645|Secondary|Overall Survival||5 years from time of restaging|||days||Full Range|Median
125585|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +80-+90|3 participants were not analyzed as they were deceased.||participants|||Number
125586|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +40-+60|3 participants were not analyzed because they were expired.||participants|||Number
125587|NCT00593645|Secondary|Engraftment as Measured by Percent Donor Chimerism||Day +30|2 participants were not analyzed because they expired prior to Day +30.||participants|||Number
125588|NCT00593645|Secondary|Disease Specific Response Rates|Disease-specific partial response and complete response.|One, three, six and twelve months.|"This outcome was not analyzed due to terminating the study after 7 participants were enrolled.~We felt that the engraftment as measured by percent donor chimerism provided better response details than the limited data that was collected for the disease specific partial and complete response rates."|||||
125589|NCT00593645|Primary|Six-month Treatment Related Mortality||6 months|"This outcome was not analyzed.~Enrollment to the trial was halted after three of the first seven patients expired. This fulfilled the predefined stopping rule as it was unlikely that we would achieve our primary end point of a 6 month treatment-related mortality of 10%."|||||
125590|NCT00593606|Secondary|Patient Treatment Preference Scale Question 7|What aspects do you like the least about the patch? Check all that apply.|28 days|Full Analysis Set||participants|||Number
125591|NCT00593606|Secondary|Patient Treatment Preference Scale Question 6|What aspects do you like the most about the patch?|28 days|Full Analysis Set||participants|||Number
125592|NCT00593606|Secondary|Patient Treatment Preference Scale Question 5|I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson’s disease.|28 days|Full Analysis Set||participants|||Number
125593|NCT00593606|Secondary|Patient Treatment Preference Scale Question 4|I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson’s disease.|28 days|Full Analysis Set||participants|||Number
125594|NCT00593606|Secondary|Patient Treatment Preference Scale Question 3|In comparing the patch and previous oral treatments for Parkinson’s disease, how satisfied have you been with oral medication / patch?|28 days|Full Analysis Set||participants|||Number
125595|NCT00593606|Secondary|Patient Treatment Preference Scale Question 2|Why did you decide to enter this study?|28 days|Full Analysis Set||participants|||Number
125596|NCT00593606|Secondary|Patient Treatment Preference Scale Question 1|Have you used pharmaceutical treatments for your Parkinson’s disease before the study?|28 days|Full Analysis Set||participants|||Number
125597|NCT00593606|Secondary|Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment|"The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.~Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125598|NCT00593606|Secondary|Patient Global Impression (PGI) Item 3|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)"|28 days|Full Analysis Set||participants|||Number
125599|NCT00593606|Secondary|Patient Global Impression (PGI) Item 2|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked – Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)"|28 days|Full Analysis Set||participants|||Number
125600|NCT00593606|Secondary|Patient Global Impression (PGI) Item 1 Score|"The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125601|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.2|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)"|28 days|Full Analysis Set||participants|||Number
125602|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 3.1|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked – Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)"|28 days|Full Analysis Set||participants|||Number
125603|NCT00593606|Secondary|Clinical Global Impression (CGI) Item 2 Score|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)"|28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125604|NCT00593606|Secondary|Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment|"The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.~Item 1 measures 'Severity of Parkinson’s Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set||score on scale||Standard Deviation|Mean
125605|NCT00593606|Secondary|Change in Parkinson’s Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment|The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson’s disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125606|NCT00593606|Secondary|Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment|The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125607|NCT00593606|Secondary|Change in Parkinson’s Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson’s disease.~Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value."|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125608|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125609|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125610|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125611|NCT00593606|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment|The UPDRS is a scale for the assessment of function in Parkinson’s disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.|Baseline, 28 days|Full Analysis Set, only patients with non-missing values were analyzed||score on scale||Standard Deviation|Mean
125612|NCT00593606|Primary|Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set||participants|||Number
125613|NCT00593606|Primary|Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)||Baseline, 2 days|Safety Set||participants|||Number
125614|NCT00593606|Primary|Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period||Baseline, 56 days|Safety Set||participants|||Number
125660|NCT00593606|Primary|Change in Percentage of Monocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
125661|NCT00593606|Primary|Change in Percentage of Lymphocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
125662|NCT00593606|Primary|Change in Hemoglobin|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||g/l||Standard Deviation|Mean
125663|NCT00593606|Primary|Change in Hematocrit|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||l/l*100||Standard Deviation|Mean
125664|NCT00593606|Primary|Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
125665|NCT00593606|Primary|Change in Percentage of Basophilic Granulocytes in White Blood Cell Count|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||Percentage of white blood cell count||Standard Deviation|Mean
125666|NCT00593606|Primary|Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
125667|NCT00593606|Primary|Change in QT Interval|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
125668|NCT00593606|Primary|Change in QRS Duration|"The QRS duration represents the time it takes for ventricular depolarization to occur.~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
125669|NCT00593606|Primary|Change in PR Interval|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).~Change = 28 day value minus baseline value."|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||msec||Standard Deviation|Mean
125670|NCT00593606|Primary|Change in Heart Rate|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
125671|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125672|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125673|NCT00593606|Primary|Change in Pulse Rate (Standing, After 3 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
125674|NCT00593606|Primary|Change in Diastolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125675|NCT00593606|Primary|Change in Systolic Blood Pressure (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125676|NCT00593606|Primary|Change in Pulse Rate (Standing, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
125677|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125678|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 Days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125679|NCT00593606|Primary|Change in Pulse Rate (Supine, After 5 Minutes)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
125680|NCT00593606|Primary|Change in Diastolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125681|NCT00593606|Primary|Change in Systolic Blood Pressure (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||mmHg||Standard Deviation|Mean
125682|NCT00593606|Primary|Change in Pulse Rate (Supine, After 1 Minute)|Change = 28 day value minus baseline value.|Baseline, 28 days|Safety Set, only patients with non-missing values were analyzed||beats per minute||Standard Deviation|Mean
125683|NCT00593450|Secondary|Change in Diastolic Blood Pressure From Baseline||Baseline and 1 Year|||mm Hg||Standard Deviation|Mean
125684|NCT00593450|Secondary|Change in Systolic Blood Pressure From Baseline||Baseline and 1 Year|||mm Hg||Standard Deviation|Mean
125685|NCT00593450|Secondary|Area of Lesion Change From Baseline||Baseline and 1 Year|||mm^2||Standard Deviation|Mean
125686|NCT00593450|Secondary|Area of Lesion||at 1 Year|||mm^2||Standard Deviation|Mean
125687|NCT00593450|Secondary|Dye Leakage on Angiogram||at 1 Year|||Participants|||Number
125688|NCT00593450|Secondary|Fluid on Optical Coherence Tomography||at 1 Year|||Participants|||Number
125689|NCT00593450|Secondary|Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea||Baseline and 1 Year|||μm||Standard Deviation|Mean
125690|NCT00593450|Secondary|Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea||at 1 Year|||μm||Standard Deviation|Mean
125691|NCT00593450|Secondary|Total Thickness Change From Baseline at Fovea||Baseline and 1 Year|||μm||Standard Deviation|Mean
125695|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.~In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity."|at 1 Year|||No. of Letters||Standard Deviation|Mean
125696|NCT00593450|Secondary|Visual-acuity Score and Snellen Equivalent (Frequency)||at 1 Year|||Participants|||Number
125697|NCT00593450|Primary|Change From Baseline in Visual-acuity Score (Continuous)|"Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.~In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement."|Baseline and 1 Year|All patients who had VA measured at week 52 were included in the analysis. All analyses were performed on the basis of the intention-to-treat principle. The Data and Safety Monitoring Committee recommended that data for all 23 patients at one center be excluded because of serious protocol noncompliance.||No. of Letters||Standard Deviation|Mean
125698|NCT00593450|Secondary|Change From Baseline Visual-acuity Score (Frequency)||Baseline and 1 Year|||Participants|||Number
125699|NCT00593372|Secondary|Change on Mini-Mental State Examination||End of Study||||||
125700|NCT00593372|Primary|Number of Successful Memory Tasks Completed Over Study Period.|"Successful memory tasks are those memory tasks (such as where do I keep my keys) that participants are able to consistently respond to."|8 weeks|||memory tasks|||Number
125701|NCT00593346|Secondary|Frequency of Grade 3-4 Toxicities|RTOG acute and late toxicity grading system and via a visual analog scale for pain assessment.|Up to 1 year from completion of therapy|||participants|||Number
125702|NCT00593346|Secondary|Occurrence of Mastectomy After Completion of Initial Breast-conserving Treatment||5 years after treatment completion|||participants|||Number
125703|NCT00593346|Secondary|Presence or Absence of Complications|As defined by number of participants who experienced breast infection and symptomatic fat necrosis.|5 years after treatment completion|||participants|||Number
125704|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||5 years after treatment completion|||percentage of participants|||Number
125705|NCT00593346|Primary|Local Control Using Disease-free Survival Rates||2 years after treatment completion|||percentage of participants|||Number
125706|NCT00593346|Primary|Local Control as Measured by Ipsilateral Breast Tumor Recurrence Rates||5 years after treatment completion|||percentage of participants|||Number
125707|NCT00593346|Secondary|Cosmesis Outcome as Measured by Percentage of Breast Retraction Assessment (pBRA)|-Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA)|Pre-treatment and 3 years|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of breast retraction||95% Confidence Interval|Mean
125708|NCT00593346|Secondary|Impressions of the Cause of Cosmesis Changes Over Time - Patient Reported|"-Patients filled out a form Patient Evaluation of the Treated Breast. On this form the patients were asked to compare the memory of what their breast looked like after surgery but before radiation and to compare that memory to the appearance of the breast after radiation. The patients were then asked if their breast changes were due to:~caused mostly by radiation~caused by both the radiation and surgery, but mostly by the radiation~caused by both the radiation and surgery, but mostly by the surgery~caused mostly by the surgery~can't judge which treatment caused the change~there are no changes"|3 years|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of participants|||Number
125709|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Physician Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis. Cosmetic outcome was evaluated quantitatively by percentage of breast retraction assessment (pBRA).~The global cosmetic result were scored on a 4-point scale where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of participants|||Number
125710|NCT00593346|Secondary|Excellent-good Cosmetic Outcomes - Patient Reported|"Both the participants and the treating radiation oncologist qualitatively rated cosmesis as excellent, good, fair, or poor over time and ascribed a cause for changes in cosmesis.~The global cosmetic result were scored on a 4-point scare where 0=excellent result (no difference), 1=good (small difference), 2=fair result (moderate difference) and 3=poor result (large difference)."|3 years after completion of therapy|82 participants had cosmetic outcome data through 3 years of follow-up.||percentage of participants|||Number
125711|NCT00593346|Secondary|Quality of Life Completion|-QOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC breast cancer module QLQ-BR23 questionnaires. QLQ-C30 is composed of 30 questions. QLQ-BR23 consists of 23 questions.|2 years|||percentage of participants|||Number
125712|NCT00593346|Primary|Local Control Using Ipsilateral Breast Tumor Recurrence Rates||2 years after treatment completion|||percentage of participants|||Number
125713|NCT00593333|Primary|Healed Femur Fracture|Time to clinically healed fracture as measured by weeks.|baseline to healed fracture (weeks)|||use weeks||Full Range|Mean
125714|NCT00593320|Primary|Quality of Life as Measured by the FACT-CNS Questionnaire|"The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns.~Participants can choose 0 (Not At All) up to 4 (Very Much) for each question."|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.|||||
125715|NCT00593320|Primary|Musculoskeletal Function as Measured by the Oswestry Disability Index|The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.|||||
125716|NCT00593320|Secondary|Local Control Rate|Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.|6 months after end of treatment|The first patient progressed while on treatment and the second patient was removed from study due to non-compliance.|||||
125717|NCT00593320|Primary|Pain Control Rate as Measured by the The Brief Pain Inventory|The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.|6 months after completion of treatment|One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.|||||
125718|NCT00593112|Primary|H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.||MRS Ratio||Standard Deviation|Mean
125719|NCT00593112|Primary|H MRS Scan Results - Glutamine (Gln)/Ino|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.||MRS Ratios||Standard Deviation|Mean
125720|NCT00593112|Primary|Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)|"Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)~This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate."|after 6 weeks Concerta treatment|Seven subjects who completed the protocol were not included due to a lack of baseline comparison.||MRS Ratio||Standard Deviation|Mean
125721|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits|||μg/mL||Standard Deviation|Mean
125722|NCT00592943|Primary|Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)|Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.|Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits|||μg/mL||Standard Deviation|Mean
125723|NCT00592943|Primary|Armodafinil DAT Occupancy in Caudate|Subjects received each dose level (100 and 250 mg) of armodafinil, followed by PET scans, in an open-label protocol. Repeat PET scans, using [1 1 C]altropane, determined DAT occupancy at 1 hour and 2.5 hours postdose (compared with baseline).|DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil|||μg/mL||Standard Deviation|Mean
125724|NCT00592904|Secondary|Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT|Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.|Baseline and Week 48|ITT Population||Scores on a Scale||Standard Deviation|Mean
125725|NCT00592904|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)|The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study].|Baseline and Week 48|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.||Participants|||Number
125726|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48|Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).|Baseline and Week 48|ITT Population||Scores on a Scale||Standard Deviation|Mean
125727|NCT00592904|Primary|Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.|SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Baseline and Week 48|ITT Population||Scores on a Scale||Standard Deviation|Mean
125728|NCT00592904|Primary|Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.|Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.|Baseline and Week 48|Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment.||Scores on a Scale||Standard Deviation|Mean
125729|NCT00592852|Secondary|Young Mania Rating Scale (YMRS)|This scale measures mania symptoms in children and adolescents using 11 items rated from 0 (least severe) to 4 (most severe), although 4 items are rated from 0-8. The minimum (least severe) possible score is 0, and the maximum (most severe) possible score is 60.|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.||Units on a scale||Standard Deviation|Mean
125730|NCT00592852|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|This sale measures impairment on 5 items relating to Obsessions from 0 (none) to 4 (extreme) and 5 item relating to Compulsions from 0 (none) to 4 (extreme). These scores are totaled for a range of 0 (least impaired) to 40 (most impaired).|weekly|2 participants were not included in final analysis - 1 terminated at 1 week due to non-compliance with taking study medication. 1 found ineligible prior to beginning treatment.||Units on a scale||Standard Deviation|Mean
125731|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).|Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (12 weeks)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||nmol/L||Standard Deviation|Median
125732|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)|Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||ng*ml||Standard Deviation|Mean
125733|NCT00592839|Secondary|Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).|Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.|From baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||nM BCE||Standard Deviation|Mean
125734|NCT00592839|Secondary|Mean Change in Stanford Sleepiness Scale|Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||Score on Scale||Standard Error|Least Squares Mean
125735|NCT00592839|Secondary|Mean Change in Individual Sleep Parameters on a Three-point Scale|Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the ITT cohort, defined as all subjects who were exposed to investigational product therapy and who provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit. Not all study subjects completed all data elements in their study diaries."||scores on a scale||Standard Error|Least Squares Mean
125736|NCT00592839|Primary|Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes|Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort|Baseline to End of Treatment (Week 12)|"Participants analyzed consisted of subjects from the intent-to-treat (ITT) cohort, [all subjects who were exposed to investigational product therapy,provided baseline sleep time hot flash information and sleep time hot flash data for at least one post-baseline visit]. Not all study subjects completed all data elements in their study diaries."||Awakenings||Standard Error|Least Squares Mean
125737|NCT00592774|Secondary|Analysis of Allodynia (Present/Not Present) at Week 15/EOT– by Treatment Groups ITT Population (Modified BOCF)|Allodynia is defined as a painful reaction to a non-painful stimulus.|Week 15|ITT population (Modified BOCF)||Participants|||Number
125738|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)||Scores on a scale||Standard Deviation|Mean
125739|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)|The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).|Baseline and Week 15|ITT population (Modified BOCF)||Scores on a scale||Standard Deviation|Mean
125740|NCT00592774|Secondary|Clinician Global Impression of Change (CGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed CGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used CGIC scores from Early Termination visit.||Participants|||Number
125741|NCT00592774|Secondary|Patient Global Impression of Change (PGIC) at Week 15/EOT|Changes were calculated using the modified BOCF method|Week 15|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.||Participants|||Number
125742|NCT00592774|Secondary|Change From Baseline to Week 15/EOT in Average Sleep Interference Scores|The average of the last 7 available sleep scores prior to the visit, based on the 11-point Likert-type numerical rating scale for sleep interference (where 0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]), and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)||Scores on a scale||Standard Deviation|Mean
125743|NCT00592774|Primary|Change From Baseline in Average Pain Scores by Week|Change from baseline in average pain scores by week based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.|Week 1 through Week 16|ITT Population||Scores on a scale||Standard Deviation|Mean
125744|NCT00592774|Primary|Responder Rate: Subjects With at Least 50 Percent Reduction in Pain|A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)||Percentage of Participants|||Number
125745|NCT00592774|Primary|Responder Rate: Subjects With at Least 30 Percent Reduction in Pain|A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11‑point Likert‑type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|ITT Population (Modified BOCF)||Percentage of Participants|||Number
125746|NCT00592774|Primary|Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)|Average pain scores are based on pain intensity (11‑point Likert‑type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on‑treatment scores prior to Week 15, and they were reported by treatment group.|Baseline and Week 15|Intent‑to‑Treat (ITT) Population- group of subjects who were randomized, took study drug, and had at least 1 efficacy assessment at Baseline. The modified Baseline Observation Carried Forward (BOCF) method was used.||Scores on a scale||Standard Deviation|Mean
125747|NCT00592761|Primary|Change in Duration of Hyoid Maximum Anterior Excursion|Change in the duration of maximum anterior movement of the hyoid bone during swallowing.|Baseline and 6 weeks|||seconds||Standard Deviation|Mean
125748|NCT00592761|Secondary|Change in Duration of Opening of Upper Esophageal Sphincter|Change in duration of pre- and post-treatment duration of UES opening.|Baseline and 6 weeks|||seconds||Standard Deviation|Mean
125749|NCT00592761|Secondary|Change in Oral Intake Ability|Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.|Baseline and 6 weeks|||units on a scale||Standard Deviation|Mean
125750|NCT00592761|Primary|Change in Duration of Superior Hyolaryngeal Movement|Change in duration of superior elevation of hyoid bone.|baseline and six weeks|per protocol||seconds||Standard Deviation|Mean
125751|NCT00592683|Secondary|DSM-IV Mania Symptom Checklist|The DSM-IV Mania Symptom Checklist is used to evaluate symptoms of mania. Item scores range from 0-3, with larger scores indicating greater severity. With 33 items, the maximum (most severe) score possible is 99, with the minimum (least severe) score possible being 0.|weekly for first 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.||units on a scale||Standard Deviation|Mean
125752|NCT00592683|Primary|Change in Bipolar Symptoms as Assessed by Young-Mania Rating Scale (YMRS)|The YMRS is used to evaluate symptoms of mania in children and adolescents. Items are rated from 0-4 or 0-8, with higher scores indicating greater severity. The minimum total score (least severe) is 0, and the maximum total score (most severe) is 60.|weekly for 1st 6 weeks then biweekly|14 subjects came in for week 12 assessments - included in final analysis.||Units on a scale||Standard Deviation|Mean
125753|NCT00592631|Primary|Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)|Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.|7 to 10 nights after cpap is started.|||log mg/ml||Standard Error|Mean
125754|NCT00592488|Secondary|Serum Lactate||12-36 hours||||||
125755|NCT00592488|Primary|Vasopressor Dose||6-24 hours||||||
125756|NCT00592488|Primary|Mean Arterial Blood Pressure|Mean Arterial blood pressure measured non-invasively at 18 hours|18 hours|All patients treated. Intention to treat.||units on a scale|Participants|Standard Error|Mean
125757|NCT00592475|Secondary|Change From Baseline in Serum Sodium Levels at 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 Hours and on Day 8 Post Dose|"Baseline serum sodium value is the last measurement prior to dosing.~Change from baseline is calculated as time point minus baseline."|Baseline and 0.5, 1, 2.5, 4, 6.5, 9, 12, and 24 hours and on Day 8 post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title."||mEq/L||Standard Deviation|Mean
125758|NCT00592475|Primary|Change From Baseline in Heart Rate at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table."||bpm||Standard Deviation|Mean
125759|NCT00592475|Primary|Change From Baseline in Blood Pressure at 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 Hours, and Day 8 Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 9, 12, and 24 hours, and Day 8 post dose|"Population is Safety Analysis Set (SAF): All randomized patients who received at least one dose of study medication.~The number of participants per arm is consistent for all categories of the data table."||mmHg||Standard Deviation|Mean
125760|NCT00592475|Primary|Change From Baseline in Hepatic Mean Arterial Pressure (MAP) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants included in the calculation for each timepoint is noted in the category title."||mmHg||Standard Deviation|Mean
125761|NCT00592475|Primary|Change From Baseline in Hepatic Blood Flow (HBF) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|Participants Analyzed represents FAS: All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline. (Note: 2 patients were not included in the analysis due to protocol deviations.) The number of participants included in the calculation for each timepoint is noted in the category title.||mL/min||Standard Deviation|Mean
125762|NCT00592475|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at 0.5, 1, and 1.5 Hours Post Dose|"Change from baseline is calculated as time point minus baseline.~Baseline procedures were performed prior to study drug administration."|Baseline and 0.5, 1, and 1.5 hours post dose|"Participants Analyzed represents Full Analysis Set (FAS): All randomized patients who had at least 1 dose of study drug & who had hepatic venous pressure gradient data at baseline.~The number of participants per arm is consistent for all categories of the data table."||mmHg||Standard Deviation|Mean
125763|NCT00592384|Primary|Hamilton Depression Rating Scale-Maier Subscale|The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.|0 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
125764|NCT00592384|Secondary|Hamilton Rating Scale for Anxiety||Weeks 0, 12||||||
125765|NCT00592384|Secondary|Patient Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12||||||
125766|NCT00592384|Secondary|Clinical Global Impression||Weeks 0, 1, 3, 6, 8, 10, 12||||||
125767|NCT00592384|Secondary|Sheehan Disability Scale||Weeks 0, 12||||||
125768|NCT00592384|Secondary|Satisfaction With Life||Weeks 0, 12||||||
125769|NCT00592384|Secondary|Craig Handicap and Reporting Technique||Weeks 0, 12||||||
125770|NCT00592384|Secondary|Side Effects Checklist||Weeks 0, 1, 3, 6, 8, 10, 12||||||
125771|NCT00592384|Secondary|SF-12||Weeks 0, 12, 24||||||
125772|NCT00592384|Secondary|Structured Clinical Interview for DSM IV Depression Module||Weeks 0, 12, 24||||||
125773|NCT00592384|Secondary|Modified Ashworth Spasticity Scale||Weeks 0, 1, 3, 6, 8, 10, 12||||||
125774|NCT00592384|Secondary|Modified Brief Pain Inventory||Weeks 0, 1, 3, 6, 8, 10, 12||||||
125775|NCT00592384|Secondary|Symptom Checklist-20 Depression Subscale||Weeks 0, 1, 3, 6, 8, 10, 12, 24||||||
125776|NCT00592384|Primary|Hamilton Depression Rating Scale-17|The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.|0 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
125777|NCT00592358|Secondary|Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist|A 13-item clinician-rated symptom checklist developed by Massachusetts General Hospital to measure symptoms of mania. Each item is given a rating for frequency (1=less than 4 days, 2=greater than or equal to 4 days, 3=daily) and intensity (1=mild, 2=moderate, 3=severe), which are combined to yield a composite severity score ranging from 0 (least severe) to 3 (most severe). The composite severity scores from all 13 items are summed to yield a total measure score, with a minimum score of 0 (least severe) and a maximum score of 39 (most severe).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|All participants for whom the mania checklist was available at both baseline and endpoint (8-weeks) were included in analyses.||units on a scale||Standard Deviation|Mean
125778|NCT00592358|Primary|Change in Symptoms Measured by Young Mania Rating Scale (YMRS)|The YMRS is an 11-item instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven itemsare graded on a 0 to 4 scale. The maximum possible total score is 60 (worse outcome, severe symptoms), and the minimum possible total score is 0 (no symptoms).|Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)|Participants exposed to study medication for a minimum of three weeks were included in analyses.||units on a scale||Standard Deviation|Mean
125794|NCT00591864|Primary|Sensitivity on the Per Patient Level|Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.|within 1 week of surgery or biopsy|In the 84 patients who completed the study 28 were diagnosed with breast cancer.||participants|||Number
125795|NCT00591851|Primary|Cardiac Saftey|LVEF by Muga scan|Baseline-18 months|||percentage of LVEF||Full Range|Median
125779|NCT00592319|Primary|Number of Case With Papilloma Recurrence During a 12-month Follow up|Criteria for the recurrence: the site scoring >4, plus visible lesion found in >50% of the treated tissue area, after surgery Description: The caculation of the site scoring is based on a called Derkay's scoring system: to indicate how many anatomic site involved, from the 0 (the best)to 13 (the worst),among a total of 13 laryngeal sites such as epiglottis or right true vocal cords.|12-month follow up|The paticipants for analysis were those who had the recurrence or completed follow-up period. The analysis was per protocol, and follow-up period was 12 months.||case|||Number
125780|NCT00592319|Secondary|Time Course (Month) With Papilloma Recurrence During 12-month Follow up|The measuer is reported as time course (i.e., how many month) to see papilloma recurrence if there is any such recurrence.|12 months|12-month follow-up||month||Full Range|Mean
125781|NCT00592176|Secondary|Number of Patients Having Surgical Removal of Pterygium.|The number of patients having surgical removal of pterygium within 12 months.|12 months|All subjects enrolled were analzyed.||Participants|||Number
125782|NCT00592176|Primary|The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.|"Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression~Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression."|Baseline and 3 months|All subjects enrolled were analzyed.||area in millimeters squared||Standard Deviation|Mean
125783|NCT00592072|Primary|Telephone Search|This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||symbols/ 90 min||Standard Error|Least Squares Mean
125784|NCT00592072|Primary|Map Search (1min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125785|NCT00592072|Primary|Map Search (2min)|The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125786|NCT00592072|Primary|Digit Symbol Coding|The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125787|NCT00592072|Primary|Letter/Number Sequencing|The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125788|NCT00592072|Primary|Digit Span Backward|The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125789|NCT00592072|Primary|Verbal Memory Recognition|The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125790|NCT00592072|Primary|Delayed Verbal Memory|The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125791|NCT00592072|Primary|Immediate Verbal Memory|Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.|90 minutes|With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.||units on a scale||Standard Error|Least Squares Mean
125792|NCT00591864|Secondary|Specificity|The number of women with negative imaging test per number of women without cancer.|at least one year following imaging|||participants|||Number
125793|NCT00591864|Secondary|Sensitivity on the Per Tumor Level|Number of tumors detected per number of tumors diagnosed on surgery or biopsy.|within 1 week of surgery or biopsy|||tumors|Participants||Number
125796|NCT00591773|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125797|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 , defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125798|NCT00591773|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125799|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125800|NCT00591773|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125801|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125802|NCT00591773|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125803|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125804|NCT00591773|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125805|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125806|NCT00591773|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125807|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure.|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125808|NCT00591773|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125809|NCT00591773|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125810|NCT00591773|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125811|NCT00591760|Primary|Peak VO2|changes in peak VO2|6 months|||ml/kg/min||Standard Error|Mean
125812|NCT00591734|Secondary|Objective Response Rate|The percentage of patients who experience an objective benefit from treatment|13 months||||||
125813|NCT00591734|Secondary|Overall Survival|The length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months||||||
125814|NCT00591734|Primary|Progression-free Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|13 months|||months||95% Confidence Interval|Median
125815|NCT00591721|Primary|Change From Baseline in Subscale Scores of the Fatigue Impact Scale|"Fatigue impact was measured using the Fatigue Impact Scale (FIS) (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants’ responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores"|baseline, 7 weeks (immediate post-intervention)|Intent-to-treat, imputation by maximum likelihood approach||units on a scale||Standard Deviation|Mean
125816|NCT00591591|Secondary|Apnea Hypopnea Index (AHI is the Index of Severity That Combines Apneas and Hypopneas) Determined During the Routine Sleep Study||6 hours of sleep|||Number of apnea/hypopnea per sleep hour||Standard Deviation|Mean
125817|NCT00591591|Primary|Deoxy-Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.||µM||Standard Deviation|Mean
125818|NCT00591591|Primary|Total Hemoglobin Concentration in the Brain During Sleep||6 hours of sleep|||µM||Standard Deviation|Mean
125819|NCT00591591|Primary|Oxyhemoglobin Concentration in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.||µM||Standard Deviation|Mean
125820|NCT00591591|Primary|Percentage of Oxygen Saturation in the Brain During Sleep||6 hours of sleep|Absolute Brain Oximetry: Quantitative Hemodynamic Responses of Brain During Sleep, in Healthy & OSA Subjects.||Percentage of brain oxygen saturation||Standard Deviation|Mean
125821|NCT00591578|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125822|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 24, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125823|NCT00591578|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 24, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125824|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125825|NCT00591578|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125826|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125827|NCT00591578|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125828|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125829|NCT00591578|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125830|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125831|NCT00591578|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125832|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125833|NCT00591578|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125834|NCT00591578|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125835|NCT00591578|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125836|NCT00591565|Primary|Change From Baseline at 8 Weeks in the HAM-A Scale|this is a validated clinician administered scale that can range from 0-44 (mild to severe illness).|baseline and 8wk|LOCF if two initial visits were completed||units on a scale||Standard Deviation|Mean
125837|NCT00591370|Secondary|Duration of Objective Clinical Responses|Duration of Response (Objective Clinical Responses)|24 weeks after ending treatment|||months||Full Range|Median
125838|NCT00591370|Secondary|Overall Survival|Overall survival at 18 months post treatment|18 months after ending treatment|||percentage of participants|||Number
125839|NCT00591370|Primary|Determine the Overall Objective Response Rate (CR and PR).|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From start of treatment through 24 weeks after ending treatment|||participants|||Number
125840|NCT00591344|Secondary|5 Time Sit to Stand|The time it takes to stand up and sit down five times|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125841|NCT00591344|Secondary|50 Foot Walk Speed|The speed that aerson walks over 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125842|NCT00591344|Secondary|50 ft Walk Time|Time it takes to walk 50 feet|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125843|NCT00591344|Secondary|Beck’s Depression Inventory|This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125844|NCT00591344|Secondary|Epworth Sleepiness Scale|The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125845|NCT00591344|Secondary|Parkinson ’s Disease Quality of Life|PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125846|NCT00591344|Secondary|Cognitive Function - Digit Span Forward/Backward|This tests a persons ability to remember that were read to them both forward and then backwards.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125847|NCT00591344|Secondary|Cognitive Function - Brief Test of Attention|This is a cognitive test of an individuals ability to remember number. It is a test of working memory.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125848|NCT00591344|Secondary|Cognitive Function - Stroop Test|This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125849|NCT00591344|Secondary|Functional Reach|The distance one can reach forward without taking a step.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125850|NCT00591344|Secondary|Berg Balance Scale Score|This is a overall measure of balance|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125851|NCT00591344|Secondary|Time on the Timed up and go Test|This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125852|NCT00591344|Secondary|Modified Physical Performance Test|This is an overall measure of physical fuction|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125853|NCT00591344|Secondary|Distance Walked in 6 Minutes|This is how far an individual can walk in 6 minutes|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125854|NCT00591344|Secondary|Spatiotemporal Gait Analysis|Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125855|NCT00591344|Secondary|Rise Time|This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125856|NCT00591344|Secondary|Relaxation Time|Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125857|NCT00591344|Secondary|Peak Movement Velocity|This is how fast an individual can perform a 72 degree elbow flexion movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125858|NCT00591344|Secondary|Time to Peak Velocity|Time of the onset of the movement to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125859|NCT00591344|Secondary|Qant|The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125860|NCT00591344|Secondary|Co-contraction During Limb Acceleration|the amount of agonist and antagonist activity present during limb acceleration.|Obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125861|NCT00591344|Secondary|Number of Agonist Bursts|This is the number of agonist bursts prior to peak velocity.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125862|NCT00591344|Secondary|Duration of First Agonist Burst|Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125863|NCT00591344|Secondary|Magnitude of the Agonist Burst|Magnitude of the agonist burst reflects the amount of agonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125864|NCT00591344|Secondary|Magnitude of the Antagonist Burst|the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125865|NCT00591344|Secondary|Magnitude of the First 30 ms of the Agonist Burst|The integral of the first 30 msec of the agonist EMG.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125866|NCT00591344|Secondary|The Integral of the First Agonist Burst|The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125867|NCT00591344|Secondary|Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions|This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125868|NCT00591344|Secondary|Ankle Dorsiflexion Strength|This is a measure of the MVC for ankle dorsiflexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125869|NCT00591344|Secondary|Elbow Extension Strength|This is a measure of the MVC for elbow extension|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125870|NCT00591344|Secondary|Ankle Plantar Flexion Strength|This is a measure of the MVC for ankle plantar flexion strength|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125871|NCT00591344|Secondary|Elbow Flexion Strength|This is the MVC for elbow flexion|obtained during initial evaluation & then every 6 six months to end of 2-yr training period||||||
125872|NCT00591344|Secondary|L-dopa equivalent-mg/Day|This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||mg/day||Standard Deviation|Mean
125873|NCT00591344|Secondary|On Medication UPDRS-III|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||units on a scale||Standard Deviation|Mean
125921|NCT00591006|Secondary|Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition|||percentage of BOLD activation||Standard Deviation|Mean
125874|NCT00591344|Primary|Off Medication UPDRS Part III, Motor Subscale Score|UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.|obtained during initial evaluation & then every 6 six months to end of 2-yr training period|||units on a scale||Standard Deviation|Mean
125875|NCT00591266|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125876|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6 relative to baseline, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125877|NCT00591266|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6 relative to baseline, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125878|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125879|NCT00591266|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125880|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125881|NCT00591266|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125882|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125883|NCT00591266|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125884|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125885|NCT00591266|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125886|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
126958|NCT00578812|Secondary|Mean Worst Arm Pain Visual Analog Scale|Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).|24 Months|Per protocol||mm||Standard Deviation|Mean
125887|NCT00591266|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125888|NCT00591266|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125889|NCT00591266|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125890|NCT00591253|Secondary|Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the 3 sitting blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125891|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 6, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125892|NCT00591253|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 6, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 6.|Full analysis set with last observation carried forward.||percentage of participants|||Number
125893|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125894|NCT00591253|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125895|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125896|NCT00591253|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125897|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125898|NCT00591253|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125899|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125958|NCT00590590|Primary|Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)|The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse|12 weeks|||scores on a scale||Standard Error|Mean
125900|NCT00591253|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125901|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125902|NCT00591253|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125903|NCT00591253|Secondary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 6 relative to baseline.|Baseline and Week 6.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
125904|NCT00591253|Primary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
125905|NCT00591240|Primary|Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.|"Study 1: Multiplex pathogen identification using biosensor based assay. We recruited 116 participants yielding 109 urine samples suitable for analysis and comparison between biosensor assays and standard urine culture. Biosensor based assays were used to detect multiple pathogens in the urine samples.~Study 2: Antimicrobial susceptibility testing using biosensor based assay. We recruited 222 participants yielding 252 urine samples. Corresponding biosensor and clinical microbiology culture data was available for 215 samples. 73% (157) of these samples contained bacteria. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples."|Up to 1.5 years|Urine samples were collected from participants at the Spinal Cord Injury Service for assay validation.||percentage of urine specimen|Participants||Number
125906|NCT00591227|Primary|Hospital Length of Stay|hospital length of stay in days|days|||days||95% Confidence Interval|Mean
125907|NCT00591227|Secondary|Frequency of Hypoglycemia During Emergency Room Therapy With Insulin||from emergency room admission to discharge||||||
125908|NCT00591227|Secondary|Efficacy of Blood Glucose Lowering During the Emergency Room Stay||from emergency room admission to discharge||||||
125909|NCT00591227|Secondary|Frequency of Hypoglycemia||from hospital admission to discharge||||||
125910|NCT00591227|Secondary|Average Blood Glucose During the Hospital Admission||from admission to discharge||||||
125911|NCT00591227|Primary|Length of Stay in the Hospital||from hospital admission to hospital discharge||||||
125912|NCT00591214|Secondary|Change in HCV RNA Levels of MP-424|"Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86.~Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose))."|Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86|||Log IU / mL||Standard Deviation|Mean
125913|NCT00591214|Primary|t1/2 (Half Life Period) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||hours||Standard Deviation|Mean
125914|NCT00591214|Primary|Ctrough (Plasma Trough Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||μg/mL||Standard Deviation|Mean
125915|NCT00591214|Primary|AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||μg x h /mL||Standard Deviation|Mean
125916|NCT00591214|Primary|Tmax (Time of Maximum Plasma Concentration) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||hours||Full Range|Median
125917|NCT00591214|Primary|Cmax (Maximum Observed Concentration in Plasma) of MP-424|Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.|Date were collected at Day1 to Day85|||μg / mL||Standard Deviation|Mean
125918|NCT00591019|Secondary|Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.|Simple reaction time to an auditory signal is a measure of attention.|5 weeks|||milli seconds||Standard Error|Mean
125919|NCT00591019|Primary|The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).|P50 is an auditory evoked response potential sensitive to states of arousal.|5 weeks|||milli volts||Standard Error|Mean
125920|NCT00591006|Secondary|Para-Hippocampal Activation Differences Between Treatment Conditions||At the end of each treatment condition|||percentage of BOLD activation||Standard Deviation|Mean
125922|NCT00591006|Primary|Difference in RAVLT Total T-Score Between Treatments|The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions, including short-term auditory-verbal memory, and retention of information. Test raw scores are converted to T-scores. T-scores have a mean of 30 ± 10 where higher scores are indicative of better verbal memory. Total T-score differences following study treatment interventions are reported.|At end of each treatment condition (on average 21 days between treatments)|||T-score||Standard Error|Mean
125923|NCT00590967|Secondary|Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis||5 years after completion of radiation therapy|The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed.|||||
125924|NCT00590967|Primary|Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status||1st PET scan after completion of treatment (approximately month 6)|||participants|||Number
125925|NCT00590967|Primary|Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)||30 days after completion of radiation therapy|||participants|||Number
125926|NCT00590967|Primary|Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity|-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|1 year post start of radiation therapy|||participants|||Number
125927|NCT00590902|Primary|Overall Objective Response of OSI-774|(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|53 weeks|||participants|||Number
125928|NCT00590889|Primary|Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.|Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.|1 year|subjects randomized into the study||participants|||Number
125929|NCT00590863|Secondary|Quality of Life Inventory|The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life.|Measured at Month 7|||units on a scale||Standard Deviation|Mean
125930|NCT00590863|Primary|Quick Inventory of Depressive Symptoms|Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe).|Measured at Month 7|Remission = Last 2 QIDS < 6. A chi-square test was used to compare the remission rates across the treatment groups. The Fisher's exact test was used when expected cell frequencies were <5. For binary outcomes (e.g., remission), bivariate logistic regression models were fit to estimate the effect of treatment on outcome.||percentage of participants|||Number
125931|NCT00590772|Primary|Change From Baseline in Fatigue and Daytime Sleepiness at 2 Weeks|"Daytime sleepiness was assessed on a scale of 0 (none) to 4 with 4 being severe.~To determine improvement of daytime sleepiness with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being maximal improvement.~To determine improvement of daytime fatigue with active therapy we used a scale of 0 to 4 with 0 being no improvement and 4 being significant improvement.~For all three above we used data from the last 3 days were averaged and mean of change for each day."|baseline and 2 weeks|||units on a scale||Standard Deviation|Mean
125932|NCT00590759|Secondary|A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.|Proportion of subjects in TAG 05-02 with MAEs|5 years|||participants|||Number
125933|NCT00590759|Primary|Aneurysm Related Death|Freedom from aneurysm related mortality for TAG 05-02 subjects|5 years|||participants|||Number
125934|NCT00590720|Secondary|Accumulation Index|Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528|Days 0 and 24|All participants who received at least one dose of MEDI-528 (n=7) and had available data (n=5).||Ratio||Standard Deviation|Mean
125935|NCT00590720|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.||Day||Standard Deviation|Mean
125936|NCT00590720|Secondary|Mean Trough Concentration at Last Measurable Time Point (Cmin_last)|Cmin_last of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.||Microgram per milliliter||Standard Deviation|Mean
125937|NCT00590720|Secondary|Mean Trough Concentration (Cmin)|Cmin of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150|All participants who received at least one dose of MEDI-528.||Microgram per milliliter||Standard Deviation|Mean
125938|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Minutes||Standard Deviation|Mean
125939|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Minutes||Standard Deviation|Mean
126026|NCT00589849|Primary|Evaluate the Diagnostic Accuracy of TWA in Predicting Arrhythmic Events, Cardiovascular Mortality, and Total Mortality in Patients With Acute MI||30 days||||||
125940|NCT00590720|Secondary|Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)|Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=9, 2 placebo and 7 MEDI-528).||Minutes||Standard Deviation|Mean
125941|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 150|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).||Liter x min||Standard Deviation|Mean
125942|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 56|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).||Liter x min||Standard Deviation|Mean
125943|NCT00590720|Secondary|Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)|AUC of FEV1 at Day 28|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Liter x min||Standard Deviation|Mean
125944|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Percent change||Standard Deviation|Mean
125945|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Percent change||Standard Deviation|Mean
125946|NCT00590720|Secondary|Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, 2 placebo and 7 MEDI-528).||Percent change||Standard Deviation|Mean
125947|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.|Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Liter||Standard Deviation|Mean
125948|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.|Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).||Liter||Standard Deviation|Mean
125949|NCT00590720|Secondary|Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)|The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.|Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)|All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, with 2 placebo and 7 MEDI-528).||Liter||Standard Deviation|Mean
125950|NCT00590720|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 119, and 150|All participants who received at least one dose of MEDI-528.||Participants|||Number
125951|NCT00590720|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).||Participants|||Number
125952|NCT00590720|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All participants who received at least one dose of investigational product (MEDI-528 or placebo).||Participants|||Number
125953|NCT00590590|Secondary|Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe]||12 Weeks|||Score||Standard Error|Mean
125954|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be]||12 Weeks|||Score||Standard Error|Mean
125955|NCT00590590|Secondary|Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain]||12 weeks|||Score||Standard Error|Mean
125956|NCT00590590|Secondary|Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort]||12 Weeks|||Score||Standard Error|Mean
125957|NCT00590590|Secondary|Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)|0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse|Baseline -12 Weeks|||Score||Standard Error|Mean
125959|NCT00590577|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment|The CGI-S rating scale was used to assess the severity of a subject’s overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst. The change in CGI-S score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.||Scores on a scale||Full Range|Median
125960|NCT00590577|Secondary|Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.|The PSP scale measures the degree of normal function of a subject in interpersonal relationships and social interactions. Scores range from 1 to 100, where 1 is worst and 100 is best. The average change in PSP score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The secondary outcome measures used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.||Scores on a scale||Standard Deviation|Mean
125961|NCT00590577|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment|The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.|Baseline to 13 weeks or the last post-baseline assessment|The primary outcome measure used the intent-to-treat analysis set, which consisted of all enrolled subjects who got at least 1 dose of paliperidone palmitate and had both a baseline and at least 1 post-baseline efficacy measurement during the study. For imputation of missing time points, last observation carried forward (LOCF) was used.||Scores on a scale||Standard Deviation|Mean
125962|NCT00590564|Primary|To Determine the Effects of Sho-saiko-to on Hepatic Injury in Patients With Chronic Hepatitis C Who Are Intolerant or Have a Specific Contraindication to Interferon-based Therapy.|Response is determined by improvement of 2 points or greater as per Knodell's histology activity index (HAI) scores in paired comparisons of pre and post liver biopsy|52 weeks|||participants|||Number
125963|NCT00590538|Secondary|Number of Participants With Abnormal Laboratory Safety Tests|Outcome measure will be obtained by completion of routine metabolic and hematological laboratory parameters for every participant. Metabolic testing willl include a CMP (comprehensive metabolic panel, ALT (alanine aminotransferase test), GGT (gamma-glutamyl transpeptidase), and Uric Acid; Hematological testing will include a complete blood count (CBC), and partial thromboplastin (PT/PTT).|up to 2 weeks|No analysis was completed on data collected; More clinically efficacious compounds have been identified which suggested that completion of this study might not be as critical as when initially proposed; therefore, the study was terminated by PI.||participants|||Number
125964|NCT00590538|Secondary|Number of Participants With Adverse Events|Adverse Events will be assessed and outcome measure obtained by completion of Interval history, physical and mental status examinations of every participant.|up to 2 weeks|||participants|||Number
125965|NCT00590538|Secondary|Change in FVC (Forced Vital Capacity)in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.||Liters|||Number
125966|NCT00590538|Secondary|Change in FEV1 (Forced Expiratory Volume in 1 Second) in Spirometry.|Outcome measure will be obtained from standard Pulmonary Function testing.|baseline and 2 weeks|No analysis was completed on data collected.||Liters|||Number
125967|NCT00590538|Primary|Change in Voltage (mVolt) in Nasal Epithelium|"The basis of analysis for the primary outcome measure will be the comparison of data from both the standard CF Nasal Potential Difference (NPD) Protocol compared to a modified NPD protocol including the perfusion of Genistein.~The NPD response will be compared from baseline to after study drug. NPD responses will then be compared between the Phenylbutrate group and the placebo group."|Baseline and 2 weeks|No analysis was completed on data collected; AND study was never unblinded therefore details not available.||mVolts|||Number
125968|NCT00590460|Secondary|Number of Patients With Grade III - IV Acute GVHD|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.~The grades of Graft versus Host disease are based on how much the patient's body is damaged by the stem cells attacking the organs. In general the grading ranges from grade I (minor) to grade IV (severe)."|100|||participants|||Number
125969|NCT00590460|Secondary|Number of Patients With Extensive Chronic GVHD From Day 100 to 365|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.~Chronic GVHD usually occurs later than acute GVHD. It usually occurs at least one year after the transplant. Extensive chronic GVHD is when the damage is more extensive to the body."|365 days|||participants|||Number
125970|NCT00590460|Secondary|Number of Patients With Limited Chronic GVHD From Day 100 to 365|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.~Chronic GVHD usually occurs later than acute GVHD. It usually occurs at least one year after the transplant. Limited chronic GVHD is when the damage is less extensive to the body."|365 days|||participants|||Number
125971|NCT00590460|Secondary|Number of Patients Alive at 1 Year Post Transplant||1 year|||participants|||Number
126027|NCT00589784|Primary|Overall Objective Response|Determine the overall objective response|1.5 years|||participants|||Number
125972|NCT00590460|Secondary|Number of Patients With Grade II - IV Acute Graft Versus Host Disease (GVHD)|"Graft versus Host Disease is when the new stem cells (graft) recognize that the body tissues of the patient (host) are different from those of the donor. When this happens, cells in the graft may attack the host organs, primarily the skin, the liver and the intestines.~The grades of Graft versus Host disease are based on how much the patient's body is damaged by the stem cells attacking the organs. In general the grading ranges from grade I (minor) to grade IV (severe)."|100 days|||participants|||Number
125973|NCT00590460|Secondary|Days to Platelet Count of 20,000/mm3 Without Transfusions||30 Days||||||
125974|NCT00590460|Secondary|Days to Absolute Neutrophil Count (ANC) of 500/mm3||30 Days|||days||Full Range|Median
125975|NCT00590460|Secondary|Number of Patients With Treated Related Death||100 days|||participants|||Number
125976|NCT00590460|Secondary|Number of Patients With Graft Failure||100 days|||participants|||Number
125977|NCT00590460|Primary|Number of Patients With Donor Engraftment||100 Days|||participants|||Number
125978|NCT00590369|Secondary|Patient Reported Pain|scale of 0= no pain to 10= worst pain possible|at first dressing change; generally 48 hours|||units on a scale||Standard Deviation|Mean
125979|NCT00590369|Secondary|Nursing Time||hospital stay; generally 6 days|||minutes||Standard Deviation|Mean
125980|NCT00590369|Secondary|Cost of Wound Care|cost of device/supplies used in application and dressing changes|during hospital stay; generally 6 days|||dollars (USD)||Standard Deviation|Mean
125981|NCT00590369|Secondary|Ease of Providing Nursing Care|nurse perception of ease of providing nursing care using a Likert-type scale; 5 items assessed. Responses to 1 item provided: Overall experience with nursing care issues related to the wound device. score range is 0, always very difficult, always a problem or not possible to 10, always easy, never or rarely a problem|during hospital stay; generally 6 days|||scores on a scale||Inter-Quartile Range|Median
125982|NCT00590369|Secondary|Ease of Performing Dressing Change|responses to questions using a Likert scale regarding ease of dressing change; 8 characteristics; only reported is: Apply/fasten occlusive drape to secure drainage tube; scale range is 0, very difficult to do, takes a lot of time or effort or not possible to 10, simple or very easy to do|during hospital stay; generally 6 days|||scores on a scale||Inter-Quartile Range|Median
125983|NCT00590369|Primary|5 Measures of Wound Healing: Length, Width, Depth, Undermining, Tunneling|differences in wound healing rate at first dressing between devices; since 5 variables were assessed via a centimeter ruler|first dressing change; typically within 48 hours|||centimeters||Inter-Quartile Range|Median
125984|NCT00590317|Secondary|Akithisia at 0 to 120 Min||0 to 120 min after receiving medication|||no. participants exp akathisia|||Number
125985|NCT00590317|Secondary|Nausea at 0 to 120 Min|100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea|0 to 120 minutes after receiving medication|||units on a scale||Standard Deviation|Geometric Mean
125986|NCT00590317|Primary|Vomiting at 0 to 120 Min.||0 to 120 minutes after receiving medication|Convenience sample||number of participants exp vomiting|||Number
125987|NCT00590226|Secondary|Number of Patients With Hypoglycemic Events|number of patients with hypoglycemic events as defined as BG 40-59 mg/dl|during hospitalization|||participants|||Number
125988|NCT00590226|Primary|Mean AM BG (mg/dl)|average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2|during hospitalization|||mg/dl||Standard Deviation|Mean
125989|NCT00590161|Primary|Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year.|The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and balloning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).|1 year (Baseline liver biopsy done at study entry, and subsequent liver biopsy done after one year of therapy with pentoxifylline or placebo)|Intention to treat analysis included all participants and for this analysis patients without available end of study liver biopsy were imputed as treatment failures. Results showed here are continuous variable analysis of NAS score change in patients with available end of study liver biopsy (per protocol analysis)||NAS score units||Standard Deviation|Mean
125990|NCT00590044|Secondary|Frequency of Hyperglycemia|differences between treatment groups in the number of hyperglycemic episodes (blood glucose > 200 mg/dl).|blood glucose (BG) before meals, at bedtime and as needed||||||
125991|NCT00590044|Primary|Mean Daily Blood Glucose Concentration After the Resolution of DKA|The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups.|1 year|||mg/dl||Standard Deviation|Mean
125992|NCT00590044|Secondary|Frequency of Hypoglycemia|differences between treatment groups in the number of hypoglycemic events (blood glucose < 60 mg/dl) between hours 12 to 36 (second day)|blood glucose (BG) before meals, at bedtime and as needed||||||
125993|NCT00590044|Secondary|Mean Daily Blood Glucose Concentration While on the Insulin Drip|determine differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA)|blood glucose (BG) before meals and at bedtime||||||
125994|NCT00590031|Secondary|Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality||2 years|||participants|||Number
125995|NCT00590031|Primary|Pathologic Complete Response|Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject’s best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.|2 years|||participants|||Number
125996|NCT00590018|Secondary|Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration.|Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). A lower inotrope score is better with the minimum being 0 and the maximum being 85.|2 days|||units on a scale||Standard Deviation|Mean
125997|NCT00590018|Primary|Blood Pressure.|Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration).|2 days|||mmHg||Standard Deviation|Mean
125998|NCT00590005|Secondary|Reduction in Breath pH|Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.|baseline and 21 days|225 children with asthma were enrolled in the study and completed baseline assessments. Only 40 children were followed longitudinally. The data from those 40 children are shown here.||log of hydrogen ion concentration (pH)||Standard Deviation|Mean
125999|NCT00590005|Primary|Exhaled Nitric Oxide at Baseline and Over the Observational Period|Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag|baseline and after 21 days|225 children were enrolled into the study and completed baseline assessments. Only 40 children were followed longitudinally. The results from only those 40 children are shown here.||parts per billion||Standard Deviation|Mean
126000|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale|The VSH Sleep Scale is contained in a 15 item self-report instrument that measures the quality of a patient’s sleep over the last 24 hours. Each item is scored on a 0-100 visual analog scale. The VSH is categorized into 3 sleep scales: disturbance (which measures delays and interruptions in sleep)[maximum score = 700], effectiveness (which measures how well sleep refreshed the individual) [maximum score = 600], and supplementation (which measures the need for napping) [maximum score = 400]. The higher the score the greater the value of the sleep characteristic for that patient.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
126001|NCT00589979|Other Pre-specified|Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Categories included Better, Much the Same, and Worse.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
126002|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Values of the continuous EQ-5D health state today (VAS) ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
126003|NCT00589979|Secondary|Investigator Global Assessment of Treatment Satisfaction|At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
126004|NCT00589979|Secondary|Patient Global Assessment of Treatment Satisfaction|At the end of each period, patients rated their overall satisfaction with study treatment using a 5-point categorical scale indicating: 0 - very dissatisfied; 1 - dissatisfied; 2 - no preference; 3 - satisfied; and 4 - very satisfied.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
126005|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores|Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline (Day 0) and at each clinic visit (at least every 4 weeks) or at premature discontinuation. Values of the EQ-5D index score range from -1 (worst) to 1 (best).|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
126028|NCT00589693|Secondary|28-day All-cause Mortality Rate|Number of deaths which occured up to 28 days of the study period due to all causes|Up to 28 days|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
126006|NCT00589979|Other Pre-specified|Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
126007|NCT00589979|Other Pre-specified|Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score|The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.|Baseline and end of treatment period (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
126008|NCT00589979|Secondary|Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Investigators rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale ranging from very much worse to very much improved. A similar questionnaire was completed by the Investigator."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
126009|NCT00589979|Secondary|Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain|"Patients rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale indicating: very much worse (0); much worse (1); minimally worse (2); no change (3); minimally improved (4); much improved (5); and very much improved (6)."|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
126010|NCT00589979|Secondary|Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores|The PQAS measures individual pain qualities and the impact of treatment on those qualities. Items 1-19 are each rated on an 11-point scale ranging from 0 (lowest score - no pain of that type) to 10 (highest score - the highest level of that type of pain). Average surface pain = average of PQAS items: cold, sensitive, itchy, numb, and tingling. Average deep pain = average of PQAS items: dull, cramping, throbbing, aching, and heavy. Average paroxymal pain = average of PQAS items: sharp, shooting, electric, and radiating.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
126011|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores|The Pain Relief Scale (PRS) is a 9-point categorical rating scale to assess pain relief during the 24-hours since the last assessment; 0= completely worse and 8= complete pain relief. Patients completed this assessment each day during the run-in period and each day during the double-blind treatment phase in their e-diary.|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
126012|NCT00589979|Secondary|Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)|"The Numerical Rating Scale (NRS) is an 11-point categorical rating scale to assess pain intensity (PI-NRS); 0= no pain and 10= worst possible pain. The scale is anchored on the left with No Pain and on the right with Worst Possible Pain. Patients were to complete this assessment at approximately the same time each day during the double-blind treatment period in their e-diary. The overall treatment difference for the Lidoderm (lidocaine patch 5%) and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence."|Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Units on a scale||Standard Error|Least Squares Mean
126029|NCT00589693|Secondary|Number of Patients Who Had Emergence of P. Aeruginosa Resistance|Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline|Up to 6 weeks|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
126013|NCT00589979|Secondary|Exit Status From Current Study Treatment - Yes|Exit status from a current study treatment was categorized as yes or no for patients who exited prior to the 4-week planned duration. This analysis supports the results of the primary analysis. The number of patients exiting (yes) is reported.|Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.||Participants|||Number
126014|NCT00589979|Secondary|Time-to-Exit Due to Lack of Efficacy|"Time-to-exit due to lack of efficacy was defined as a patient that met the switching criterion (a 2-category change in Pain Relief Scale (PRS) in the worsening direction [increasing pain or decreasing pain relief] for 2 consecutive days) or was discontinued from the current period or study due to lack of efficacy. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief.~No patients discontinued from the study due to lack of efficacy."|Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: No patients exited a study period due to lack of efficacy, therefore median time-to-exit could not be calculated."||days||95% Confidence Interval|Median
126015|NCT00589979|Primary|Time-to-Exit From Current Study Treatment|Time-to-exit was defined as the number of days at which a patient either met the switching criterion [a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study.|Baseline, Period 1 (up to 4 weeks ±2 days), Period 2 (up to 4 weeks ±2 days), Period 3 (up to 4 weeks ±2 days), or Premature Discontinuation|"The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: Kaplan-Meier estimates for median time-to-exit from current study treatment could not be calculated for Period 2 or Period 3, because the survival distribution function did not fall below 0.5000."||Days||95% Confidence Interval|Median
126016|NCT00589914|Secondary|The Change From Baseline in the PSP Score|The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.||Scores on a scale||Standard Deviation|Mean
126017|NCT00589914|Secondary|The Change From Baseline for the CGI-S Score|The CGI-S rating scale is used to rate the severity of a patient’s psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient’s condition at a given time. A qualified rater administered the CGI-S.|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]|The intent-to-treat (ITT) analysis set of patients included those randomized to treatment after IEC/IRB approval of protocol Amendment INT-4 who received at least 1 injection of double-blind study drug and had at least 1 efficacy measurement during the double-blind treatment period.||Scores on a scale||Standard Deviation|Mean
126018|NCT00589914|Primary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia|The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).|Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)|The per-protocol analysis set of patients included those randomized to treatment after IEC/ IRB approval of protocol Amendment INT-4 with both a baseline measurement and at least 1 postrandomization measurement on the primary efficacy variable, a minimum exposure of 36 days to the double-blind treatment regimen, and no major protocol violations.||Scores on a scale||Standard Deviation|Mean
126019|NCT00589888|Primary|Changes in Systolic Blood Pressure|systolic blood pressure change from baseline during an oral 64-gram fat load in obese normotensive subjects.|at the end of the 8 hours|||mmHg||Standard Deviation|Mean
126020|NCT00589888|Primary|Changes in Systolic Blood Pressure From Baseline|systolic blood pressure change from baseline during an oral 32-gram fat load in obese normotensive subjects.|at the end of 8 hours|||mmHg||Standard Deviation|Mean
126021|NCT00589888|Primary|Changes in Systolic Blood Pressure|BP change from baseline during an 8-hour 20% intralipid @ 40cc/hr infusion in obese normotensive subjects.|at the end of 8 hours|||mmHg||Standard Deviation|Mean
126022|NCT00589888|Primary|Change in Systolic Blood Pressure|systolic blood pressure change from baseline during an 8-hour 20% intralipid @ 20cc/hr infusion in obese normotensive subjects.|at the end of 8 hours|||mmHg||Standard Deviation|Mean
126023|NCT00589888|Secondary|The Secondary Outcomes of Interest Are the Effects of Increased FFAs on BP, Endothelial Function and Inflammatory Markers After Oral Fat Load (Chylomicron Pathway) Versus IV Administration of Intralipid Infusion in Obese Normotensive Subjects.||Changes in BP assessed every 2 hours during the 8 hours study; Lipid changes assessed every 2 hours during the 8-hour study, and Flow-mediated dilatation, peripheral compliance, PWA, and HRV assessed at 0,4, and 8 hours||||||
126024|NCT00589888|Primary|Change in Systolic Blood Pressure|systolic blood pressure change from baseline during an 8-hour normal saline infusion in obese normotensive subjects.|at the end of the 8-hours|||mmHg||Standard Deviation|Mean
126025|NCT00589849|Primary|Event Free Survival at 1 Year|Survival without ventricular tachycardia/ventricular fibrillation (VT/VF) or sudden cardiac death at 1 year|12 months|||participants|||Number
126030|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
126031|NCT00589693|Secondary|Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline|The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
126032|NCT00589693|Primary|Clinical Cure Rate at the End-of-treatment (EOT) Visit|The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary.|End-of-treatment (Day 10 or Day 11)|Microbiological Intent-to-Treat (MITT) - subset of all ITT (all randomized patients who received at least a partial dose of study medication) patients who had at least 1 qualifying pneumonia pathogen.||Participants|||Number
126033|NCT00589667|Secondary|Median Overall Survival|To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine.|2 years|There were 25 assessable patients as described in the protocol.||months||Full Range|Median
126034|NCT00589667|Primary|Overall Objective Response|"To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|All assessable patients as indicated in the protocol.||participants|||Number
126035|NCT00589628|Primary|Effects of Infliximab on Uveitis Disease Activity.|Number of subjects with improvement in uveitis, defined as a two step decrease in level of inflammation (as defined by SUN criteria, AC cells, vitreous haze) or decrease to grade 0. A grading scheme of 0 indicating (<1 cell/ocular field) low levels of inflammation to 4+ indicating (>50 cells/ocular field) indicating high levels of inflammation.|9 months|1 subject lost to follow up||participants|||Number
126036|NCT00589563|Secondary|Incidence of Disease Relapse/Progression at 2 Years Post HSCT|Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment.|2 year point estimate was provided.|||Percentage of patients who relapsed||95% Confidence Interval|Number
126037|NCT00589563|Primary|Severity of Chronic GVHD|All Patients were considered for the evaluation of chronic GVHD severity.|Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT|||participants|||Number
126038|NCT00589563|Primary|Cumulative Incidence of Chronic GVHD|Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.|2 year point estimate was provided.|||Percentage of patients developing cGVHD||95% Confidence Interval|Number
126039|NCT00589563|Secondary|Event Free Survival at Two Years Post HSCT|Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event.|2 year point estimate was provided.|||Percentage of patients with an event||95% Confidence Interval|Number
126040|NCT00589563|Secondary|Overall Survival at Two Years Post HSCT|Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date.|2 year point estimate was provided.|||Percentage of patients who died||95% Confidence Interval|Number
126041|NCT00589563|Secondary|Non-relapse Mortality at Two Years Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|2 year point estimate was provided.|||Percentage of patients with a NRM||95% Confidence Interval|Number
126042|NCT00589563|Secondary|Non-relapse Mortality at 100 Days Post HSCT|Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.|100 day point estimate was provided|||Percentage of patients with a NRM||95% Confidence Interval|Number
126043|NCT00589563|Secondary|Occurence of Sinusoidal Obstructive Syndrome (SOS)|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS.|Median Follow Up: 28 Months (Range: 1-49 Months)|||participants|||Number
126044|NCT00589563|Secondary|Occurrence of Thrombotic Microangiopathy|Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.|Median Follow Up: 28 Months (Range: 1-49 months)|||participants|||Number
126045|NCT00589563|Secondary|Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation|Participants were monitored throughout the trial (median of 28 months) for various infections/complications.|Median Follow Up: 28 months (Range: 1-49 months)|||participants|||Number
126085|NCT00588809|Secondary|Proportion of Subjects With NRAS Mutation|Proportion of Subjects With NRAS Mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.||percentage of participants|||Number
126046|NCT00589563|Secondary|Time to Platelet Count Recovery (Engraftment)|Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10^9 L obtained on different days.|Patients were evaluated until platelet recovery, a median of 14 days|27 of the 32 patients had platelet recovery.||Days||Full Range|Median
126047|NCT00589563|Secondary|Time to Absolute Neutrophil Count Recovery (Engraftment)|Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10^9/L (500/mm3) for three consecutive laboratory values obtained on different days|Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT|28 of the 32 patients had absolute neutrophil count recovery.||Days||Full Range|Median
126048|NCT00589563|Primary|Severity of Acute GVHD|All patients were considered for the evaluation of the severity of acute GVHD.|100 Days Post HSCT|||participants|||Number
126049|NCT00589563|Primary|Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100|Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.|100 Days Post Hematopoietic Stem Cell Transplant (HSCT)|||Percentage of patients developing aGVHD||95% Confidence Interval|Number
126050|NCT00589550|Secondary|Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood||Up to 1 year||||||
126051|NCT00589550|Secondary|Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome||up to 1 year||||||
126052|NCT00589550|Secondary|Overall Survival||up to 1 year||||||
126053|NCT00589550|Secondary|Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year||||||
126054|NCT00589550|Secondary|Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.||up to 1 year||||||
126055|NCT00589550|Primary|Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.||up to 2 months||||||
126056|NCT00589550|Primary|Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate||up to 2 months||||||
126057|NCT00589303|Primary|Cardiac Hospitalization Within Six Months of Enrollment|Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.|Six months after enrollment|Intent-to-treat||participants|||Number
126058|NCT00589290|Primary|Chromosomal Gains or Losses in Comparative Genomic Hydridization in Thymoma and Thymic Cancer|Utilize a patients tumor tissue to determine if there is any correlation between chromosomal gains or losses in comparative genomic hybridization in thymoma and thymic carcinomas and clinical outcomes.|46 months|Unpublished data from Dr. Giaccone's lab does not reveal an association between these parameters and outcomes in patients with thymic malignancies. Hence we do not plan to perform analyses for these outcome measures and there is no known negative clinical implications associated with this.|||||
126059|NCT00589290|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|26 months|||Participants|||Number
126060|NCT00589290|Primary|Number of Participants With a Partial Response|Response is defined by the Response Evaluation Criteria in Solid Tumor (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. For additional details about the RECIST criteria see the protocol Link module.|25.5 months|||Participants|||Number
126061|NCT00589277|Secondary|7 Day Abstinence|The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up.|3 month follow up|Per protocol||participants|||Number
126062|NCT00589277|Secondary|24 Hour Abstinence|The number of survey respondents that had abstained from smoking at the 2 week follow up.|2 week follow up|Per protocol||participants|||Number
126063|NCT00589277|Primary|Quit Attempt|Percentage of those that self reported attempting to quit smoking at the 2 week follow up.|2 week follow up|Per protocol||participants|||Number
126064|NCT00589108|Secondary|Percentage of Knees Surviving at 5 Years|Kaplan-Meier analysis of five-year implant survival rate|5 years post-surgery|||percentage of knees|||Number
126065|NCT00589108|Secondary|Knee Society Stair Climbing Score|The stair-climbing portion of the Knee Society clinical rating system assigns a maximum score of 50 points for patients able to ascend and descend stairs in a normal fashion, 40 points for patients needing a rail to descend, 30 points for patients using a rail in both directions, 15 points for patients able to ascend but not descend at all, and 0 points for patients unable ascend or descend. Because stair ascent and descent put substantial demands on the patellofemoral joint, we used that portion of the Knee Society clinical rating system as a proxy for patellofemoral function in this study.|two years post-surgery, five years post-surgery|||units on a scale||Full Range|Mean
126066|NCT00589108|Secondary|Knee Society Pain Score|The Knee Society Pain Score includes walking and climbing stairs. The maximum score per knee is 50 indicating no pain, and 0 indicates severe pain. Therefore the total score (for both knees) could range from 0 to 100.|5 years post-surgery|||units on a scale||Standard Deviation|Mean
126067|NCT00589108|Secondary|Knee Society Function Score|The Knee Society Function Score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. The minimum function score is 0.|5 years post surgery|||units on a scale||Standard Deviation|Mean
126068|NCT00589108|Primary|Maximum Knee Flexion|The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.|2 years post-surgery, 5 years post-surgery|||degrees||Full Range|Mean
126069|NCT00588965|Secondary|Tpeak-end Interval (Tpe)|Tpeak-end interval was measured at rest, exercise, and recovery on placebo and on propranolol.|Measured after 2 weeks on each intervention|||ms||Standard Deviation|Mean
126070|NCT00588965|Primary|QTc Response to Exercise on Versus Off Beta-blocker.|To minimize the effect of heart rate on QT, QT was measured at heart rates between 100 and 110 beats per minute during exercise (on and off beta-blocker) and during recovery (on and off beta-blocker).|2 weeks on each treatment then exercise test|Please note that this was a crossover study. There were 35 subjects and each subject completed both the placebo and beta-blocker arm.||ms||Standard Deviation|Mean
126071|NCT00588861|Primary|Harris Hip Score|"The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent. 80-89 is considered Good. 70-79 is considered Fair. Less than 70 is considered Poor."|10 Years Post-Operative|This population represents patients that returned for follow-up per protocol. Because no patients returned at the primary outcome measure time frame (10 years), 0 patients were analyzed at 10 years.|||||
126072|NCT00588861|Secondary|Harris Hip Score Pain|"Harris Hip Score Pain is detailed below as mean score for the Harris Hip Score Pain question. 44 being the highest score, and 0 being the lowest score. 44 is considered None/Ignores. 40 is considered Slight/Occasional. 30 is considered Mild. 20 is considered Moderate. 10 is considered Marked. 0 is considered Totally Disabled."|Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year|This population represents patients that returned for follow-up per protocol.||Mean Hip Pain||Standard Deviation|Mean
126073|NCT00588848|Secondary|Cardiopulmonary Complications||72 hours||||||
126074|NCT00588848|Secondary|Apnea-Hypopnea Index (AHI)|Events are defined as apneas and hypopneas. AHI values are typically categorized as 5-14.9 events/hr = mild; 15-29.9 events/hr = moderate; and >= 30 events/hr = severe|On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep. Study was terminated early due to enrollment problems.||events per hour||Full Range|Mean
126075|NCT00588848|Primary|Sleep Related Hypoxemia||On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.|3 of the subjects randomized to the use of their usual CPAP slept less than 10 minutes on their night after surgery and thus were excluded from further analysis as the outcomes are based on events during sleep.||Percentage of time < 90% saturation||Full Range|Mean
126076|NCT00588822|Secondary|Percentage of Subjects With > 50% Reduction of Monoclonal Protein Titer at 6 Months|Monoclonal immunoglobulins measured included Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM).|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
126077|NCT00588822|Secondary|Percentage of Subjects Having One or More Stable Hand Grip Strength Ergometry Values for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving stable hand grip strength dynamometry values (no more than 10% better or worse relative to baseline at the 6 month visit on either side).|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
126078|NCT00588822|Secondary|Percentage of Patients Having Improvement in the Hand Grip Strength Ergometry Value for Either Hand at 6 Months|Grip strength was measured by a dynamometer in both hands at baseline and every three months until the final study visit. Response criteria was defined as achieving improvement in hand grip strength dynamometry values (>10% better relative to baseline at the 6 month visit on either side).|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
126079|NCT00588822|Secondary|Percentage of Subjects With at Least 1 Grade Improvement in the Modified Rankin Score at 6 Months|The Modified Rankin Scale was used to determine functional disability as follows: 0 = asymptomatic; 1 = symptoms not interfering with manual activities/walking normally; 2 = minor difficulties in manual activities/walking independently without support; 3 = unable to perform some manual activities/walking independently with support; 4 = unable to eat, dress or wash independently/needing assistance to walk; 5 = no useful tasks performed with upper limbs/confined to wheelchair. Therefore, scores could range from 0 to 5, with higher values indicating greater disability.|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
126080|NCT00588822|Secondary|Percentage of Subjects Whose Disease Has Stabilized or Responded, for Either Side of the Body, as Measured by NIS at 6 Months|"The Neuropathy Impairment Score (previously called the Neurologic Disability Score [NDS]) is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist’s judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.~The NIS score was measured on both sides of the body, the worst score recorded reported as 1 for each individual subject. Stability was defined as change of less than 10 points in the NIS total score. Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months|||percentage of subjects||95% Confidence Interval|Number
126081|NCT00588822|Primary|Percentage of Subjects With at Least 10 Points Improvement in the Neuropathy Impairment Score (NIS) for Either Side of the Body at 6 Months|"The Neuropathy Impairment Score [previously called the Neurologic Disability Score (NDS)] is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist’s judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100% disability. NIS total score was calculated as the sum of the 35 items, ranging from 0 to 140, with higher score indicating greater disability or impairment.~The neurologist measured the NIS score on both sides of the body, but recorded worst score and reported as 1 for each individual subject (i.e., each subject had only 1 reported score.)~Improvement was defined as at least 10 points improvement in NIS total score, that is, reduction in the number of points on the scale."|baseline, 6 months|A dichotomous measure was used so that subjects who discontinued participation prematurely could be included as non-responders.||percentage of subjects||95% Confidence Interval|Number
126082|NCT00588809|Secondary|Proportion of Subjects With KIT Mutation|Proportion of subjects with KIT mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.||percentage of participants|||Number
126083|NCT00588809|Secondary|Proportion of Subjects With FLT3 ITD Mutation|Proportion of subjects with FLT3 ITD mutation|baseline (0 weeks)|FLT3 ITD mutation status was not available for one patient.||percentage of participants|||Number
126084|NCT00588809|Secondary|Proportion of Subjects With KRAS Mutation|Proportion of subjects with KRAS mutation|baseline (0 weeks)|The analysis includes the 41 patients with samples available for analysis.||percentage of participants|||Number
126086|NCT00588809|Secondary|Proportion of Subjects With Baseline p-ERK Activation|Proportion of subjects with baseline p-ERK activation|baseline (0 weeks)|The analysis includes the 20 patients with samples available for analysis.||percentage of participants|||Number
126087|NCT00588809|Primary|Response Rate for Subjects Without FLT3 ITD Mutation|"Responses were defined using standard criteria developed by an International Working Group.~[Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642–9.]~In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR)."|Up to 52 weeks|Analysis only includes subjects without FLT3 ITD mutation.||percentage of participants|||Number
126088|NCT00588692|Secondary|Change in Arterial Elastance|Elastance is a measure of the tendency of a hollow organ to recoil toward its original dimensions upon removal of a distending or compressing force. Effective arterial elastance was determined by the ratio of end systolic BP/stroke volume (SV).|baseline, 6 months|||mmHg/ml||Standard Deviation|Mean
126089|NCT00588692|Secondary|Change in Augmentation Index|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.~Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months|||percentage of change in AIx||Standard Deviation|Mean
126090|NCT00588692|Secondary|Change in Central Diastolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months|||mmHg||Standard Deviation|Mean
126091|NCT00588692|Secondary|Change in Central Systolic BP|Central blood pressure (CBP) is the pressure in the aorta, which is the large artery into which the heart pumps. This was determined by noninvasive radial tonometry, which undergoes transfer function using customized software to derive CBP tracings.|baseline, 6 months|||mmHg||Standard Deviation|Mean
126092|NCT00588692|Secondary|Change in Brachial Diastolic BP|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.~There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)~Brachial diastolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months|||mmHg||Standard Deviation|Mean
126093|NCT00588692|Secondary|Change in Brachial Systolic Blood Pressure (BP)|"Blood pressure is a measure of the force of the blood flowing against the walls of your arteries as it moves through your body.~There are two numbers in a blood pressure reading. This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood. The second or lower number is the diastolic pressure and is the measure taken when your heart is at rest (80 in the example)~Brachial systolic BP was determined by a standard oscillometric device (Dinemap, Critikon)."|baseline, 6 months|||mmHg||Standard Deviation|Mean
126094|NCT00588692|Secondary|Change in Mitral E Wave Deceleration Time|The deceleration time (DT) is the time taken from the maximum E point to baseline. Normally in adults it is less than 220 milliseconds. The DT was measured by pulse wave doppler.|baseline, 6 months|||milliseconds (ms)||Standard Deviation|Mean
126095|NCT00588692|Secondary|Change in Mitral E/A Ratio|The E/A ratio is a marker of the function of the left ventricle of the heart; it is determined by echocardiography, an ultrasound-based cardiac imaging modality. Abnormalities in the E/A ratio on Doppler echocardiography suggest that the left ventricle, which pumps blood into the circulation, cannot fill with blood properly in the period between contractions. The E/A ratio is the ratio of peak early transmitral inflow velocity and peak late mitral inflow velocity.|baseline, 6 months|||ratio||Standard Deviation|Mean
126096|NCT00588692|Secondary|Change in Mitral E Velocity|The Mitral E velocity is the speed at which blood fills the ventricle. It is determined by echocardiography, an ultrasound-based cardiac imaging modality.|baseline, 6 months|||cm/sec||Standard Deviation|Mean
126097|NCT00588692|Secondary|Change in Stroke Volume|Stroke volume (SV) is the volume of blood pumped from one ventricle of the heart with each beat. SV was determined from pulse wave (PW) and continuous wave (CW) Doppler in the LV outflow tract.|baseline, 6 months|||ml||Standard Deviation|Mean
126098|NCT00588692|Secondary|Change in LV Ejection Fraction|"The ejection fraction is the percentage of the volume in the left ventricle ejected during a cardiac cycle. The normal ejection fraction is 55 to 75 percent. EF = (EDV ‑ ESV) / EDV where EF = ejection fraction, EDV = volume of blood in the left ventricle at end‑diastole, ESV = volume of blood in the left ventricle at end‑systole.~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7)."|baseline, 6 months|||percentage of LV blood volume||Standard Deviation|Mean
126113|NCT00588406|Primary|FEV1 Percent Predicted||4 hours post-randomization|||percent predicted of FEV1||Standard Deviation|Mean
126114|NCT00588380|Secondary|Insulin Secretion at 210-240 Minutes|The 240 minute value represents the mean of values obtained at 210, 220, 230, and 240 minutes.|210 - 240 minutes after GLP-1 infusion|All participants completing the study.||10^-9 min^-1||Standard Error|Mean
126099|NCT00588692|Secondary|Change in LV End Systolic Volume|"End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle. End systolic volume can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV end systolic volumes was determined from the apical 4 and 2 chamber views using Simpson’s method of discs, along with EF."|baseline, 6 months|||ml||Standard Deviation|Mean
126100|NCT00588692|Secondary|Change in Left Ventricle (LV) End Diastolic Volume|"End-diastolic volume (EDV) is the volume of blood in the right and/or left ventricle at end load or filling in (diastole). An increase in EDV increases the preload on the heart and, through the Frank-Starling mechanism of the heart, increases the amount of blood ejected from the ventricle during systole (stroke volume).~Ventricular Data was derived from comprehensive echo-Doppler/Tissue Doppler Echo (TDE) study performed at rest, during and immediately after exercise, along with noninvasive blood pressure assessment (GE Vivid7). LV EDV was determined from the apical 4 and 2 chamber views using Simpson's method of discs, along with ejection fraction (EF)."|baseline, 6 months|||ml||Standard Deviation|Mean
126101|NCT00588692|Secondary|Change in Heart Rate||baseline, six months|||bpm||Standard Deviation|Mean
126102|NCT00588692|Primary|Change in Aortic Augmentation Index (AIx) According to Ejection Fraction Subgroups|"Aortic stiffness increases with aging, further augmenting cardiac load. One important repercussion of aortic stiffening is an increase in pulse wave velocity. As the outgoing pressure wave caused by ventricular ejection encounters zones of impedance mismatch, it is partially reflected backward, summing with the incident wave, to increase central aortic blood pressure. The magnitude of this systolic pressure wave reflection can be quantified by AIx.~Aortic pressures were assessed in the seated position after 5 minutes rest. Aortic pulse waveform analysis was performed using a noninvasive, high-fidelity hand held tonometer placed over the radial artery. The built-in, custom software was then used to convert radial pressure waveforms to central aortic waveforms, which more accurately reflect LV afterload. The ratio of this augmented pressure to aortic pulse pressure is defined as the augmentation index (AIx)."|baseline, 6 months|||percentage of change in AIx||Standard Deviation|Mean
126103|NCT00588692|Primary|Change in Peak Oxygen Uptake (VO2) During Maximal Effort Exercise Stress Test According to Ejection Fraction Subgroups|Peak oxygen uptake (VO2) is the maximum rate of oxygen consumption as measured during incremental exercise, most typically on a motorized treadmill. Maximal oxygen consumption reflects the aerobic physical fitness of the individual. VO2 data was obtained via standard breath-by-breath expired gas analysis. Ejection Fraction Subgroups are based on participants reported at baseline.|baseline, 6 months|For the EF subgroup 25-49%, n=48, 24 SphygmoCor Unblinded, 24 SphygmoCor Blinded. For the EF subgroup 35-49%, n=33, 14 SphygmoCor Unblinded,. 19 SphygmoCor Blinded. 2 subjects had EF either <25 or >50, and they were not included in the analysis.||percentage of change in Peak VO2||Standard Deviation|Mean
126104|NCT00588666|Secondary|The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.||3 years|||percentage of participants|||Number
126105|NCT00588666|Primary|Evaluate the Time to Disease Progression|Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI, 92(3):205-216, 2000]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria.|3 years|||months||95% Confidence Interval|Median
126106|NCT00588640|Primary|Number Who Reached a Safe Dose|The number of patients who reached a safe and well tolerated dose of d-methadone|2 years|||participants|||Number
126107|NCT00588536|Primary|Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX.||Conclusion of the study|||participants|||Number
126108|NCT00588471|Secondary|Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI|"The EndoPAT is a noninvasive test that involves putting probes on the index fingers of both hands and evaluating the blood flow to one hand before and after inflating a blood pressure cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will now show no blood flow, while the sensor on the opposite index finger will continue to display your normal blood flow level. After several minutes, the blood pressure cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, however, the blood vessels are unhealthy.~The results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.|||||
126109|NCT00588471|Primary|Change in Serum High Sensitivity C-Reactive Protein (hsCRP)|"The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows:~Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L"|baseline, within 24 hours post percutaneous coronary intervention|The study was terminated early because not enough subjects could be recruited.|||||
126110|NCT00588445|Secondary|Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data|Each patient provides two binary variables: presence/absence of mutation and responder/non responder. The association between the two will be tested using the Fisher's exact test for the resulting 2x2 table.Changes in expression levels within a patient will be assessed using a paired t-test. Similarly differences in expression levels between responders and non-responders will be assessed using a two-sample t-test. Appropriate adjustment will be made for the multiple comparisons problem that arises because there are over 21,000 probe sets on the U133A array.|2 years|||percentage of participants|||Number
126111|NCT00588445|Primary|The Radiographic Response to Gefitinib|Radiographic response is defined as a minor response ( > 25% decrease in the sum of the products of measured lesions)|21 days|||participants|||Number
126112|NCT00588406|Secondary|Hospitalization||6 hours|||percentage of participants|||Number
126115|NCT00588380|Primary|Insulin Secretion at 150-180 Minutes.|The 180 minute value represents the mean of the values obtained at 150, 160, 170, and 180 minutes.|150 - 180 minutes after GLP-1 infusion|all participants completed the study||10^-9 min^-1||Standard Error|Mean
126116|NCT00588354|Secondary|Pain Score at 4 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|4 weeks|||Units on a scale||Standard Deviation|Mean
126117|NCT00588354|Secondary|Pain Score at 2 Weeks as Measured by the Multidimensional Pain Inventory (MPI)|The MPI is a comprehensive instrument comprised of 12 scales divided into three parts for assessing a number of dimensions of the chronic pain experience including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Reference: Kearns RO, Turk DC, Rudy TC. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain 1985; 23:345-356. Subscales were not used; the DOS WHYMPI computer program version 2.1 was used to score the instrument. Scores range from 0 (no pain) to 100 (highest pain). A score of 50 is the mean for patients with chronic pain.|2 weeks|||Units on a scale||Standard Deviation|Mean
126118|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|4 weeks|||Units on a scale||Standard Deviation|Mean
126119|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by Oswestry Low Back Pain Disability Questionnaire (ODI)|This questionnaire measures a patient's permanent functional disability. The questionnaire consists of 10 sections with 6 statements each of increasing point value (from 0 to 5). The score is a percentage of the total, with higher score showing greater disability. Minimum detectable change is 10%, with a 90% CI. Change of less than this may be attributable to error in measurement.|2 weeks|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
126120|NCT00588354|Secondary|Pain Disability Score at 4 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|4 weeks|||Units on a scale||Standard Deviation|Mean
126121|NCT00588354|Secondary|Pain Disability Score at 2 Weeks as Measured by the Roland-Morris Disability Questionnaire|This scale measures functional disability due to back pain. The score of the scale is the total number of items checked, from a minimum of 0 (no disability) to a maximum of 24 (great disability). Roland MO, Morris RW. A study of the natural history of back Pain. Part 1: development of a reliable and sensitive measure of disability in low back pain. Spine 1983; 8:141-144.|2 weeks|||Units on a scale||Standard Deviation|Mean
126122|NCT00588354|Secondary|Pain Intensity Score at 2 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|2 weeks|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
126123|NCT00588354|Primary|Pain Intensity Score at 4 Weeks as Measured by Pain Intensity Numerical Rating Scale (PI-NRS)|11-point ordinal scale measuring patient pain, ranging from 0 (no pain) to 10 (most severe/disabling pain).|4 weeks|Intention to Treat (ITT)||Units on a scale||Standard Deviation|Mean
126124|NCT00588341|Primary|Overall Objective Response (Complete Response or Partial Response)|"The Response Evaluation Criteria in Solid Tumors (RECIST) will be used to determine treatment response.~Clinical Complete Response (CRc) Disappearance of all target lesions and non-measurable disease.~Pathological Complete Response (CRp) A CRc in which a lymph node dissection done after completing temozolomide treatment shows no pathological evidence of melanoma. Partial Response (PR) A greater or equal then 30% in the sum of the longest diameter of all target lesions relative to baseline measurement"|2 years|||participants|||Number
126125|NCT00588237|Primary|Overall Objective Response|as determined by the GOG RECIST criteria|2 years|||participants|||Number
126126|NCT00588159|Secondary|Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively|Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively|48 hours postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).||mg||Standard Deviation|Mean
126127|NCT00588159|Primary|Average Pain Score With Coughing on Second Morning After Surgery|Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.|Second morning after surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy.Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).||Unites on a scale||Standard Deviation|Mean
126128|NCT00588159|Primary|Average Pain Score With Coughing the First Morning Following Surgery|Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10.|First morning following surgery|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).||Units on a scale||Standard Deviation|Mean
126170|NCT00587678|Secondary|Triglycerides||2 years|||mg/dl||Standard Deviation|Mean
126171|NCT00587678|Secondary|High Density Lipoprotein Cholesterol||2 years|||mg/dl||Standard Deviation|Mean
126129|NCT00588159|Secondary|Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively|Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively.|3 months postoperatively|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Patients who rated their average pain 1 or greater were included.||Participants|||Number
126130|NCT00588159|Secondary|Opioid Consumption in First 24 Hours Postoperatively||24 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001).||mg||Standard Deviation|Mean
126131|NCT00588159|Primary|Average Pain Score at Rest|Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine.|48 hours|The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst).||Units on a scale||Standard Deviation|Mean
126132|NCT00588146|Primary|Change in Hemoglobin|The hemoglobin level is expressed as the amount of hemoglobin in grams (gm) per deciliter (dL) of whole blood.|baseline, one year|Only 3 subjects completed the study, so the numbers were too low to analyze the study.|||||
126133|NCT00588094|Primary|Improve the Overall Response Rate|assessing the response rate (CR+PR)|2 years|||participants|||Number
126134|NCT00587990|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent Heart Attack||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
126135|NCT00587990|Secondary|Minnesota Living With Heart Failure (MLHF) Questionnaire||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
126136|NCT00587990|Secondary|New York Heart Association (NYHA) Functional Class||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
126137|NCT00587990|Secondary|Peak VO2 (by Treadmill Determination) and 6-minute Walk Test||Measured at baseline and Months 6 and 18 follow-ups||||||
126138|NCT00587990|Secondary|Serial Troponin and Creatine Kinase MB (CK-MB) Values||Measured every 12 hours for the first 48 hours after surgery||||||
126139|NCT00587990|Secondary|Cardiac Computed Tomography Measures of ISS, Left Ventricular Ejection Fraction, and End Diastolic and End Systolic Volumes||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
126140|NCT00587990|Secondary|Pulmonary Function - Forced Expiratory Volume in 1 Second (FEV1) Results||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
126141|NCT00587990|Secondary|Hematology, Clinical Chemistry, and Urinalysis Values||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
126142|NCT00587990|Secondary|48-hour Ambulatory Electrocardiogram (ECG) Recordings||Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up||||||
126143|NCT00587990|Secondary|Treatment Emergent Adverse Event Rates||Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up||||||
126144|NCT00587990|Secondary|MRI and Echocardiographic Measures of Infarct Scar Size (ISS) and Left Regional and Global Ventricular Function||Measured over the 6-month follow-up period and at Month 18 follow-up||||||
126145|NCT00587990|Primary|Incidence of Serious Adverse Events (SAEs)|Incidence of serious adverse events (SAEs), defined as the 6-month post-cardiac surgery for coronary artery bypss grafting CABG SAE proportion of patients experiencing sustained ventricular arrhythmias, ectopic tissue formation, or sudden unexpected death|Measured at Month 6 after surgery|||percentage of patients||95% Confidence Interval|Number
126146|NCT00587964|Primary|Local Control|"following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI.~No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease."|1 year|||participants|||Number
126147|NCT00587860|Secondary|Bowel Symptom Score (BSS) at 24 Weeks|The BSS is a five question, 100-mm visual analog scale of four IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea), and an overall severity scale. The best possible value would be 0 (no symptoms) and the worst is 500 (severe symptoms). BSS was assessed on a bi-weekly basis.|24 weeks|||Units on a scale||Full Range|Median
126148|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|24 weeks|||Units on a scale||Full Range|Median
126149|NCT00587860|Secondary|IBS Symptoms Moderately or a Lot Better|Number of participants who stated their IBS symptoms were moderately better or a lot better at 24 weeks.|24 weeks|||participants|||Number
126150|NCT00587860|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|We measured CES-D Score at baseline as well as bi-weekly throughout the study. The CES-D is a self-reported 20 question survey designed to measure depressive symptomatology in the general population. The possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|12 weeks|||Units on a scale||Full Range|Median
126172|NCT00587678|Secondary|Total Cholesterol||2 years|||mg/dl||Standard Deviation|Mean
126151|NCT00587860|Secondary|Irritable Bowel Syndrome - Quality of Life (IBS-QoL) Score|The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. The IBS-QOL was measured at baseline, week 12 and week 24. The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.|12 weeks of treatment|||Units on a scale||Full Range|Median
126152|NCT00587860|Secondary|Adequate Relief ≤ 50% During the Last 4 Weeks of Therapy|"Participants who reported yes or no to having adequate relief of their IBS symptoms at least 50% during the last 4 weeks of therapy."|Last 4 weeks of therapy|||Percentage of Participants|||Number
126153|NCT00587860|Secondary|Bowel Symptom Score (BSS) Amongst Subgroups|Median (average) BSS amongst the different IBS subgroups (diarrhea, constipation, pain, and bloating). The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain.|12 weeks|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.||Scores on a scale||Full Range|Median
126154|NCT00587860|Primary|Overall Bowel Symptom Scores (BSS)|"The primary end point was the overall self-reported BSS after 12 weeks of therapy for all randomized participants to assess for differences between treatment groups at the end of the treatment period (12 weeks).~The BSS is a 100-mm visual analog scale for the different symptoms of IBS (pain/discomfort, constipation, diarrhea, and overall severity). Symptoms on the BSS can range from 0 = no pain to 100 = extreme pain."|After 12 weeks of treatment|Analysis is based on the intention to treat (ITT) paradigm, including all randomized patients. Assuming standard deviation of the overall BSS symptom score is ~75, then 35 per group provides 80% power to detect about a 50% difference which is based on a 2-sample t-test assuming the distribution of Bowel Symptom Survey (BSS) values.||Scores on a scale||Full Range|Median
126155|NCT00587847|Secondary|Rate of Infections|Number of participants who developed clinical or laboratory evidence of infection.|Weekly then every 2 weeks then every 3 weeks|All participants who received at least one dose of alemtuzumab were analyzed for safety.||participants|||Number
126156|NCT00587847|Primary|Time to Progression (Months)|Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.|Every 8 weeks|All patients who were entered on study were analyzed according to NCI Working Group Response Criteria for CLL. Adverse events were graded on a scale of 1 to 4, where possible, according to the NCI Common Toxicity Criteria, Version 2.0.||months||Full Range|Mean
126157|NCT00587834|Secondary|Pain Absent After 3 Days (Superiority)|Pain Assessment(Modified Intent-to-Treat Population)|Day 3||||||
126158|NCT00587834|Secondary|Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)|The sensitivity of Gintuit, Free Gingival Graft (FGG) and palatal donation sites was assessed with a puff of air and rated by the Investigator as none, mild, moderate or severe sensitivity. The sensitivity of Control was determined as the most sensitive of FGG and palatal donation sites.|6 months|See description in primary outcome measures. The presence of Coe-Pak (protective periodontal dressing) at Week 1 prohibited the assessment of sensitivity for 14 subjects. The analysis was performed on 71 of the 85 subjects evaluated for efficacy.||Participants|||Number
126159|NCT00587834|Secondary|Patient Preference After 6 Months/Early Termination (Superiority)|Number of patients expressing preference for Gintuit.|6 months|See description in primary outcome measure.||participants||95% Confidence Interval|Number
126160|NCT00587834|Secondary|Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (80% success) for a 1 mm KT threshold after six months.|6 months|See description in primary outcome measure.||Percentage of Participants||95% Confidence Interval|Number
126161|NCT00587834|Secondary|Texture Same as Adjacent Tissues After 6 Months (Superiority)|An examiner assessed texture of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as “More Firm”, “Equally Firm”, or “Less Firm” as compared to adjacent, non-treated tissue. A match in texture with the surrounding tissue is considered a positive aesthetic outcome.|6 months|See description in primary outcome measures.||Participants|||Number
126162|NCT00587834|Secondary|Color Same as Adjacent Tissues After 6 Months (Superiority)|An examiner assessed color of both treated sites compared with the adjacent, non-treated tissue. The assessment was recorded as “More Red”, “Equally Red”, or “Less Red” as compared to adjacent, non-treated tissue. A match in color with the surrounding tissue is considered a positive aesthetic outcome.|6 months|See description in primary outcome measure.||Participants|||Number
126163|NCT00587834|Primary|Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.|The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.|6 months|Per protocol the first 2 subjects per Investigator were training subjects and evaluated for safety only. There were 11 training subjects and the remaining 85 subjects were analyzed for all efficacy outcomes.||percentage of participants||95% Confidence Interval|Number
126164|NCT00587769|Secondary|Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|6 months|||Participants|||Number
126165|NCT00587769|Primary|Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks|Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations|12 weeks|||Participants|||Number
126166|NCT00587678|Secondary|V02 - Maximal Oxygen Consumption||2 years|||ml/min/kg||Standard Deviation|Mean
126167|NCT00587678|Secondary|6-minute Walk Distance||2 years|||ft.||Standard Deviation|Mean
126168|NCT00587678|Secondary|Log Treadmill Exercise Time||2 years|||log time in seconds||Standard Deviation|Mean
126169|NCT00587678|Secondary|Magnetic Resonance Angiographic Index|MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.|2 years|||units on scale (0 = normal, 4 = worst)||Standard Deviation|Mean
126173|NCT00587678|Primary|Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.|Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.|2 years|||seconds||Standard Deviation|Mean
126174|NCT00587678|Primary|Perfusion Index|Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.|2 years|||Units on a scale (0 = worst, 1 = best)||Standard Deviation|Mean
126175|NCT00587678|Secondary|Low Density Lipoprotein Cholesterol||2 years|||mg/dl||Standard Deviation|Mean
126176|NCT00587678|Primary|Plaque Volume|SFA plaque volume|2 years|||cm^3||Standard Deviation|Mean
126177|NCT00587639|Secondary|Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)|The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60).|At study visit 30|||units on a scale||Standard Deviation|Mean
126178|NCT00587639|Primary|Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)|The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.|Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)|||units on a scale||Standard Deviation|Mean
126179|NCT00586729|Primary|Percentage of Grafted Area That is Viable at Day 14|Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color|14 days|Per protocol||Percentage area||Standard Deviation|Mean
126180|NCT00586729|Secondary|Hospital Cost Per Patient|Average hospital irrigant cost per patient|Volume used from admission to discharge|Per protocol||Dollars||Standard Deviation|Mean
126181|NCT00586729|Secondary|Length of Stay|Average hospital length of stay in days|0 days, 3 days, 5 days and 14 days post-operation|Per protocol||Days||Standard Deviation|Mean
126182|NCT00586716|Secondary|Negative B and T Cell Crossmatch||1year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.|||||
126183|NCT00586716|Primary|Elimination of Donor Specific Antibodies||1 year|Study was terminated and no data for the outcome was collected/analyzed because it could not be located.|||||
126184|NCT00587587|Secondary|Decreased Utilization of Intralesional Steroid Intervention|The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.|52 weeks|mITT population (randomized subjects only)||Injections per Participant||Standard Deviation|Mean
126185|NCT00587587|Secondary|Subject Global Assessment|Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||Participants|||Number
126186|NCT00587587|Secondary|Physician Global Assessment|Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||Participants|||Number
126187|NCT00587587|Secondary|Degree of Recurrence (Scar Thickness)|Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.|Week 52 or Last visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||mm||Standard Deviation|Mean
126188|NCT00587587|Secondary|Degree of Recurrence (Scar Firmness)|Scar firmness measured by Cutometer in millimeters.|Week 52 or Last Visit|mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.||mm||Standard Deviation|Mean
126189|NCT00587587|Secondary|Cumulative Incidence of Keloid Recurrence at Week 52|Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.|52 weeks|Cumulative assessment, mITT population for randomized subjects only||participants|||Number
126190|NCT00587587|Secondary|Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)|"Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.~BSS is a composite score where the individual scores from the following categories are summed:~Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).~Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar)."|Baseline to Week 52 or Last Visit|Modified ITT (mITT) for randomized subjects only. Last Visit is the score recorded at last subject visit with non-missing data.||Units on a scale||Standard Deviation|Mean
126191|NCT00587587|Primary|The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.|"Summary of all reported adverse events (AE) in the intent to treat (ITT) population.~AE was defined as any adverse change in the subject’s medical status compared with the subject’s baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject’s pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study."|52 weeks|ITT analysis per protocol. Report of at least 1 treatment emergent AE.||Participants|||Number
126192|NCT00587483|Secondary|Time to Discharge From the Hospital||Participants were followed from the date of randomization until the date of discharge from the hospital, assessed up to 60 days.|||Days||Standard Deviation|Mean
126193|NCT00587483|Secondary|Time to Discharge From the Intensive Care Unit||Participants were followed from the date of randomization until the date of discharge from the Intensive Care Unit, assessed up to 40 days.|||Days||Standard Deviation|Mean
126194|NCT00587483|Secondary|Use of Vasopressors|Number of participants per arm who required the use of vasopressors in the post-operative period.|Participants were followed from randomization until time to discharge from the hospital.|||Participants|||Number
126195|NCT00587483|Secondary|Incidence of Arrhythmias in the Post-Operative Period|Number of participants per arm who experienced arrhythmias while on floor care following dismissal from the ICU.|Participants were followed from dismissal from the ICU until dismissal from the hospital.|||Participants|||Number
126196|NCT00587483|Secondary|Incidence of Arrhythmias Other Than Ventricular Fibrillation|Number of participants per arm who experienced arrhythmias other than ventricular fibrillation while in the ICU.|Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|||Participants|||Number
126197|NCT00587483|Secondary|Number of Defibrillation Attempts||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (IIT)||Participants|||Number
126198|NCT00587483|Primary|Participants Experiencing Ventricular Fibrillation Requiring Defibrillation During the 60 Minute Period Following Myocardial Reperfusion||Participants were followed from randomization through the 60 minute period following myocardial reperfusion.|Intention to Treat (ITT)||Participants|||Number
126199|NCT00587431|Secondary|The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.|Docetaxel Pharmacokinetic parameters for cycles 1 and 2.|at Cycle 1 and 2|A population pharmacokinetic model was fit to the data from all individuals simultaneously using a non-linear mixed effects modeling. This was performed using NONMEM. The NONMEM model accounts for between-patient, between-course, and residual variability (random effects) as well as parameter differences predicted by covariates (fixed effects).||L/hr||Standard Deviation|Mean
126200|NCT00587431|Primary|PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy||Conclusion of the study (at 6 months then at 18 months post-treatment)|||participants|||Number
126201|NCT00587288|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation|Participants may have been included in more than 1 category. AEs summarized were those that began or worsened after dispensation of the study drug and before 30 days after the last dose of study drug. If the severity of an AE was missing, the AE was reported as “severe.” If drug relationship of an AE was missing, the AE was reported as “probably related.” WFT=withdrawn from treatment.|From start of study drug through 15 weeks + 30 days|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||participants|||Number
126202|NCT00587288|Secondary|Percentage of Participants With Clinical Asthma Exacerbations (CAEs)|A CAE was defined as a 20% or more decrease in forced expiratory volume in 1 second (FEV1, absolute value) from the baseline value, a requirement for emergency treatment of asthma, hospital admission for asthma, or treatment with 3 or more days of oral corticosteroids for asthma worsening.|up to 15 weeks|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.||percentage of participants|||Number
126203|NCT00587288|Secondary|Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels||End of Screening or Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||percent change in eosinophil levels||Standard Deviation|Mean
126204|NCT00587288|Secondary|Change From Baseline to End of Therapy in Percent Predicted FEV1|The change in percent predicted FEV1 from baseline to End of Therapy was calculated from the FEV1 measured during pulmonary function tests using standard spirometry measurements. Each participant’s percent predicted FEV1 was calculated by adjusting the FEV1 for age, sex, height and race. The percent predicted FEV1 was then calculated by comparing the predicted FEV1 to the observed FEV1 using the Crapo formula (Crapo et al 1981a, Crapo and Morris 1981b, Crapo et al 1982).|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||percent predicted FEV1||Standard Deviation|Mean
126205|NCT00587288|Secondary|Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)|The change in FEV1 from baseline to End of Therapy was determined. FEV1 was measured during pulmonary function tests using standard spirometry measurements.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug with an assessment at Baseline and End of Therapy.||L||Standard Deviation|Mean
126206|NCT00587288|Secondary|Percentage of ACQ Responders at End of Therapy|Responders were defined as participants achieving at least a 0.5 reduction from baseline to End of Therapy in ACQ score. The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline, End of Therapy (up to 15 weeks)|ITT Analysis Set: all participants who received any amount of randomly assigned study drug.||percentage of participants|||Number
126207|NCT00587288|Primary|Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score|The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.|Baseline through End of Therapy (up to 15 weeks)|Intent-to-treat (ITT) Analysis Set: all participants who received any amount of randomly assigned study drug.||units on a scale||Standard Deviation|Mean
126208|NCT00587223|Secondary|Proportion of Wounds Experiencing an Adverse Event||through 12 months|There was only 1 enrolled subject in the study; this endpoint was descriptively reported, no statistical analyses were performed.||proportion of treated wounds|||Number
126213|NCT00587223|Primary|Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12||Through 12 weeks|no analysis performed as only 1 subject enrolled||proportion (%) of treated wounds|||Number
126214|NCT00587171|Secondary|Distribution of Change in Randot Preschool Steroacuity From Baseline to 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|Baseline to 17 weeks|||participants|||Number
126215|NCT00587171|Secondary|Distribution of Randot Preschool Stereoacuity at 17 Weeks|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 weeks|||participants|||Number
126216|NCT00587171|Secondary|Mean (SD) of Change in Intereye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||letters||Standard Deviation|Mean
126217|NCT00587171|Secondary|Mean (SD) of Intereye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||letters||Standard Deviation|Mean
126218|NCT00587171|Secondary|Mean (SD) of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||letters||Standard Deviation|Mean
126219|NCT00587171|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||participants|||Number
126220|NCT00587171|Secondary|Mean (SD) of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||letters||Standard Deviation|Mean
126221|NCT00587171|Secondary|Distribution of Fellow Eye Visual Acuity at 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||participants|||Number
126222|NCT00587171|Primary|Mean (SD) of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||letters||Standard Deviation|Mean
126223|NCT00587171|Primary|Distribution of Change in Amblyopic Eye Visual Acuity From Baseline to 17 Weeks|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|Baseline to 17 weeks|||participants|||Number
126224|NCT00587171|Primary|Mean (SD): Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||letters||Standard Deviation|Mean
126225|NCT00587171|Primary|Distribution of Distance Visual Acuity in Amblyopic Eye at 17-week Outcome|Visual acuity was measured with the electronic early treatment diabetic retinopathy (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||participants|||Number
126226|NCT00587158|Secondary|Degree of Interstitial Fibrosis on Graft Biopsy at One Year|"Interstitial fibrosis refers to degree of scarring or fibrous tissue formed in the kidney. Renal pathologists reviewed biopsies of the subject's kidney grafts for fibrosis, with results expressed using the Banff schema; Quantitative criteria: ci0 = fibrosis observed in up to 5% of cortical area, ci1 = fibrosis in 6%-25% of cortical area (mild) , ci2 = fibrosis in 26%-50% of cortical area (moderate), ci3 = fibrosis in greater than 50% of cortical area (severe). The degree of interstital fibrosis for this study was defined and reported as follows: a Banff ci score of greater than 0 and less than 2 considered mild fibrosis and a ci score greater than or equal to 2 as moderate to severe fibrosis."|1 year post kidney transplant|Per-protocol analysis; graft biopsies were not available for all subjects||Participants|||Number
126227|NCT00587158|Secondary|24-hour Total Protein in the Urine at 1 Year Post Transplant|A urine total protein test is conducted to detect excess protein in the urine. This test helps determine an individual's kidney functioning. Protein is not usually present in urine; therefore, presence of protein in the urine is a sign of abnormality. The quantity of protein in a sample of urine collected over 24-hour was measured and reported in milligrams per day.|1 year post kidney transplant|Per-protocol analysis. The 24-hour urine collection was not completed for all subjects.||mg/day||Standard Deviation|Mean
126229|NCT00587158|Secondary|Mean Estimated Glomerular Filtration Rate (eGFR) at One Year|Glomerular filtration rate describes the amount that fluid is filtered through the kidney and can be estimated by using serum creatinine. eGFR is reported in milliliters per minute per 1.73 m^2 of body-surface area.|1 year post kidney transplant|Per-protocol analysis||mL/min/1.73m^2||Standard Deviation|Mean
126230|NCT00587158|Secondary|Episodes of Acute Cellular Rejection (ACR) of the Renal Transplant|The number of episodes of ACR, as proven by renal biopsy, were recorded.|Baseline to 1 year post kidney transplant|Per-protocol analysis.||episodes|||Number
126231|NCT00587158|Secondary|Number of Subjects Who Died or Lost Their Renal Graft During First Year|The number of subject who died (or experienced failure of their kidney surgical graft) during the first year following kidney transplant are reported here.|Baseline to 1 year post kidney transplant|Per-protocol analysis.||participants|||Number
126232|NCT00587158|Secondary|Change in Hip Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements made of the hip bones using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis. Not all subjects were able to undergo the DEXA scan of the hip at baseline and one-year [Control n = 41/Treatment n = 40].||T-score||Standard Deviation|Mean
126233|NCT00587158|Secondary|Change in Lumbar Spine Bone Mineral Density (BMD)|BMD was measured using a Dual Energy X-ray Absorptiometry (DEXA) scan and reported by T-scores, measurements of the lower spine made using the scan. The T-score reflects how your bone density measurement compares to normal healthy adults. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Osteopenia is a condition of decreased bone mass or density but not thin enough to be diagnosed as osteoporosis. Osteoporosis is a condition where bone mass/density has diminished to a level causing higher risk of fracture. The average change in T-score from baseline to one year is reported.|Baseline, 1 year post kidney transplant|Per-protocol analysis; Not all subjects were able to undergo the DEXA scan of the spine at baseline and one-year [Control n = 42/Treatment n = 41].||T-score||Standard Deviation|Mean
126234|NCT00587158|Secondary|Serum Bone Alkaline Phosphatase (BAP) Level Over Time|BAP is a marker of bone turn-over, is measured in the serum and reported in micrograms per liter (mcg/L).|Baseline, 21 days, 90 days and 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified study visits. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:~Baseline: 43/41, Day 21: 34/38, Day 90: 36/36, Day 365: 43/41"||mcg/L||Full Range|Median
126235|NCT00587158|Secondary|Serum Parathyroid Hormone (PTH) Level Over Time|Parathyroid hormone (PTH) is a hormone synthesized in the body's parathyroid glands that controls bone health. PTH controls calcium and phosphorus levels in the body. It is measured in the serum and reported in picograms per milliliter (pg/mL).|Baseline, 3 weeks, 3 months, 1 year post kidney transplant|"Per-protocol analysis; the number of samples obtained at each time point varied because not all subjects were able to undergo laboratory testing at the specified timepoints. The number of subjects samples per treatment group were as follows [Timepoint: Control(n)/Treatment(n)]:~Baseline: 43/41, Day 21: 44/41, Day 90: 44/43, Day 365: 44/43"||pg/mL||Full Range|Median
126236|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the lower spine made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the lumbar spine at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis; Data were not available for 1 subject from each arm because these subjects did not have the one year DEXA scan of the spine. [Control n = 43/Treatment n = 42].||Participants|||Number
126237|NCT00587158|Secondary|Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year|Osteopenia/Osteoporosis are conditions where bone mineral density is lower than normal, reported by T-scores, measurements of the hip made using an Dual Energy X-ray Absorptiometry (DEXA) scan. The T-score is measured and compared to a normal healthy adult. A normal bone density results in a T-score between +1.0 and -1.0. A T-score of less than or equal to -1.5 was used for this study to define the presence of osteopenia/osteoporosis. Each participant will be categorized as having or not having osteopenia/osteoporosis of the hip at the end of the first post-transplant year based on bone mineral density results.|1 year post kidney transplant|Per-protocol analysis. Data were not available for 2 control subjects and 2 treatment subjects, as these subjects did not have the DEXA scan of the hip done at one year. [Control n=42/ Treatment=41]||Participants|||Number
126238|NCT00587158|Primary|Number of Subjects With Hyperparathyroidism at One Year|Parathyroid hormone (PTH) is a measure of how well the parathyroid gland is working and is measured by a blood test. Hyperparathyroidism (increased PTH) is defined as PTH blood value greater than 65 picograms/milliliter in the absence of hypocalcemia (low calcium) or if the subject had a parathyroidectomy (surgical removal of parathyroid glands) during the first year post-transplant.|1 year post kidney transplant|Analysis was performed by the intention-to-treat principle, comprised of all subjects enrolled, who will have taken at least one dose of study medication and have both screening and any post-screening efficacy data recorded. The last observation was carried forward for missing values.||Participants|||Number
126239|NCT00587132|Primary|Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.|Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.|Day 1 of study|All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.||participants|||Number
126240|NCT00587041|Secondary|24 Hour Urine Oxalate Excretion|The amount of oxalate excreted in the urine over a 24 hour period, a risk for calcium oxalate kidney stones|At end of study, approximately 6 weeks|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.||mmol/L||Standard Deviation|Mean
126241|NCT00587041|Primary|Change in 24-hour Urinary Supersaturation for Calcium Oxalate|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate. Values for supersaturated ions are expressed in units of Gibbs free energy.|Time zero (on diet but no drug), 6 weeks (on drug and diet)|As urine values for the final visit were not available for 5 subjects, they were not included in the analysis.||KJoules/mol||Standard Deviation|Mean
126242|NCT00586898|Primary|Response|Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.|6 months|||participants|||Number
126243|NCT00586846|Primary|Radiographic Response|to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).|2 years|||participants|||Number
126244|NCT00586820|Secondary|Percent Change in Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) From Immediately Pre-PCI to 8 and 16 Hours Post-PCI|CK-MB is a cardiac marker that can demonstrate the development of heart muscle necrosis resulting from an acute interruption of blood supply to a part of the heart. CK-MB is measured by a blood test.|immediately pre-PCI, 8 hours post-PCI, 16 hours post-PCI|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.||percent change||Inter-Quartile Range|Median
126245|NCT00586820|Primary|Average Peak Velocity (APV) Immediately Following Percutaneous Coronary Intervention (PCI)|Coronary microvascular blood flow will be assessed following successful PCI by measuring APV in the culprit vessel using Doppler echocardiography.|immediately following PCI procedure|One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.||cm/s||Inter-Quartile Range|Median
126246|NCT00586703|Secondary|Efficacy - Overall Survival|Evaluate the efficacy of the regimen in terms of overall survival (OS).|7 years|Participants who completed infusion.||months||Full Range|Mean
126247|NCT00586703|Primary|Toxicity|Evaluate the safety of NK cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplantation from mismatched donors: Toxicity including mortality, occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.|8 weeks|Participants who were able to receive infusion.||participants|||Number
126248|NCT00586690|Secondary|Efficacy - Disease Progression|Evaluate efficacy of natural killer (NK) cell infusions in terms of number of patients with disease progression.|3 years|Participants who completed cell infusion.||participants|||Number
126249|NCT00586690|Secondary|Efficacy - Overall Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of overall survival (OS).|8 years|Participants who completed infusion. 9 patients were still alive at the time of this analysis.||months alive post-infusion||Full Range|Mean
126250|NCT00586690|Secondary|Efficacy - Progression Free Survival|Evaluate efficacy of natural killer (NK) cell infusions in terms of progression free survival (PFS) in number of months without disease progression.|3 years|Participants who completed cell infusion.||months||Full Range|Mean
126251|NCT00586690|Primary|Toxicity|Evaluate the toxicity post-infusion including mortality, occurrence of acute graft versus host disease (GVHD) and other severe toxicity until a minimum of 8 weeks following the last infusion, then at least monthly for 3 additional months. Unacceptable toxicity was defined as grade ≥ III aGVHD of the gut or liver or Grade 4 aGVHD of the skin lasting > 7 days; other Grade 4 toxicity from the procedure in the major organs that lasted > 5 days; or treatment-related mortality (TRM). Though these infusions are provided early following transplantation and severe toxicity could still have occurred due to the primary transplant procedure, for this study any aGVHD or other toxicities occurring after the first day of infusion of the natural killer (NK) cell enriched Donor Lymphocyte Infusions (DLIs) is considered here as study related.|5 months|Participants who completed cell infusion.||participants|||Number
126252|NCT00586664|Secondary|Ocular Mucus Discharge|"Percent of Eyes with Ocular Mucus Discharge as measured 7, 15 & 20 minutes post-CAC.~Scored as absent or present"|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with OMD Present|||Number
126253|NCT00586664|Secondary|Tearing|Percent of Eyes with Tearing as measured 7, 15 & 20 minutes post-CAC. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with Tearing Present|||Number
126254|NCT00586664|Secondary|Total Non-Ocular Composite Symptom|Total Non-Ocular Composite Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126255|NCT00586664|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126256|NCT00586664|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126482|NCT00583947|Primary|Change From Predose in Mean Serum Potassium|Change in mean serum potassium at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population||mEq/L||Standard Deviation|Mean
126257|NCT00586664|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126258|NCT00586664|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126259|NCT00586664|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126260|NCT00586664|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126261|NCT00586664|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126262|NCT00586664|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126263|NCT00586664|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126264|NCT00586664|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
126265|NCT00586625|Primary|Ocular Comfort|"A 4-step grading scale with half unit (1-step) increments allowed:~0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable"|Day 8 & Day 22|||Scores on a scale||Standard Deviation|Mean
126266|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14).~Period 2 is defined as the administration of the booster dose until the end of the study (Month 15)."|31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.||subjects|||Number
126267|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after the booster vaccination (month 15)|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.||subjects|||Number
126268|NCT00586612|Secondary|Number of Subjects Reporting Solicited Symptoms (Local and General)|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.|During the 4-day follow-up period following booster vaccination|Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.||subjects|||Number
126269|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||titer||95% Confidence Interval|Geometric Mean
126483|NCT00583947|Primary|Mean Serum Potassium Levels||Predose, 2 hours and 6 hours postdose 1|Intent to treat population||mEq/L||Standard Deviation|Mean
126270|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|"Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL).~Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||mIU/mL||95% Confidence Interval|Geometric Mean
126271|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
126272|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values|"Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.~Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component."|Prior to (Month 14) the booster vaccination|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
126273|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
126274|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
126275|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
126276|NCT00586612|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)|Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).|Prior to (Month 14) and one month after the booster vaccination (Month 15)|Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.||subjects|||Number
126277|NCT00586612|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire primary vaccination phase|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
126278|NCT00586612|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after each primary vaccination|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
126279|NCT00586612|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
126280|NCT00586612|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.|During the 4-day follow-up period after any primary vaccination dose|Analysis was performed on the Primary Total Vaccinated Cohort.||subjects|||Number
126281|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||Titer||95% Confidence Interval|Geometric Mean
126282|NCT00586612|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer|rSBA-MenC titers are given as geometric mean titers (GMTs).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||Titer||95% Confidence Interval|Geometric Mean
126283|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||mIU/mL||95% Confidence Interval|Geometric Mean
126284|NCT00586612|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration|Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||mIU/mL||95% Confidence Interval|Geometric Mean
126285|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
126286|NCT00586612|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration|Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
126287|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126288|NCT00586612|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126289|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|One month after the third dose|Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126290|NCT00586612|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values|Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126291|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126292|NCT00586612|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values|rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126293|NCT00586612|Secondary|Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter|Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126294|NCT00586612|Secondary|Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values|Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Before vaccination (at Day 0)|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126295|NCT00586612|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8|rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.||subjects|||Number
126296|NCT00586612|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.|One month after the third vaccination|Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data.||subjects|||Number
126297|NCT00586573|Primary|DSM-IV ADHD Rating Scale (AISRS) Score Change|"AISRS used to assess 18 individual criteria symptoms of ADHD in DSM-IV on a severity grid (0=not present, 3=severe; minimum score=0, maximum score=54). This is a composite score assessing both inattention and hyperactivity, which are not assessed individually in this scale.~Score change from baseline."|Endpoint, following 12 weeks Memantine Monotherapy|||Units on a scale||95% Confidence Interval|Mean
126298|NCT00586521|Secondary|Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire|Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat-population||Transformed score||Standard Deviation|Mean
126299|NCT00586521|Secondary|Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score|Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage|Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)|intent-to-treat||Gilbert score (0-100)||Standard Deviation|Mean
126300|NCT00586521|Secondary|Number of All Bleeds|Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intention-to-treat||All bleeds||Standard Deviation|Mean
126301|NCT00586521|Primary|Number of Joint Bleeds|Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6|Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)|intent-to-treat population||Number of joint bleeds||Standard Deviation|Mean
126302|NCT00586495|Post-Hoc|Number of Participants Who Died|Number of subjects who died due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"Overall Survival is shown in Secondary Outcome Measure: Overall Survival."||participants|||Number
126303|NCT00586495|Secondary|Overall Disease Control|Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.||participants|||Number
126304|NCT00586495|Secondary|Time to Objective Response|Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.||days||Full Range|Median
126305|NCT00586495|Secondary|Overall Response Duration|Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population.||days||95% Confidence Interval|Median
126306|NCT00586495|Secondary|Overall Survival (OS)|Time from initiation of treatment to death due to any cause.|From start of treatment of the first subject until 45 months later, assessed every 3 months|"ITT population. The median overall survival (OS) and the lower limit of 95% Confidence interval were not estimable because more than half (n=51) of the study population were censored. The number of participant who died is shown in Post-Hoc Outcome Measure: Number of Participants who Died."|||||
126307|NCT00586495|Secondary|Best Tumor Response|Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|ITT population||participants|||Number
126308|NCT00586495|Primary|Progression Free Survival (PFS)|Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).|From start of treatment of the first subject until 45 months later, assessed every 8 weeks|Intention to treat (ITT) population.||days||95% Confidence Interval|Median
126309|NCT00586482|Other Pre-specified|Self-reported Abstinence From Smoking||Post-operative day 8|||participants|||Number
126310|NCT00586482|Other Pre-specified|Minnesota Nicotine Withdrawal Score|This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms.|Morning of surgery, pre-operatively|||units on a scale||Standard Deviation|Mean
126311|NCT00586482|Other Pre-specified|Self-reported Time to Last Cigarette||Morning of surgery, pre-operatively|||Hours||Standard Deviation|Mean
126312|NCT00586482|Secondary|Self-reported Abstinence|Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.|Morning of surgery, pre-operatively|||participants|||Number
126313|NCT00586482|Primary|Exhaled Carbon Monoxide Concentration||Morning of surgery, pre-operatively|||Parts per million||Standard Deviation|Mean
126314|NCT00586469|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Within 21 days after vaccination|||participants|||Number
126315|NCT00586469|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day period following each vaccination.|The analysis was performed on the Total Vaccinated Cohort.||participants|||Number
126316|NCT00586469|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face|During the 4-day period following each vaccination.|Analysis was performed on the Total Vaccinated cohort.||participants|||Number
126317|NCT00586469|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow up period following vaccination.|Analysis was performed on the Total Vaccinated cohort.||participants|||Number
126318|NCT00586469|Secondary|The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B|"The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table.~The fold increase corresponds to the Unit of Measure Factor."|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Factor|||Number
126319|NCT00586469|Secondary|Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1|Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21. This table presents the SCF for the H1 strain. The SCF for the other strains are addressed in the next table.|At Day 21 compared to Day 0|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Factor|||Number
126320|NCT00586469|Secondary|Number of Seroprotected Participants.|The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||participants|||Number
126321|NCT00586469|Secondary|Number of Participants Who Seroconverted.|The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.|At Day 21.|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||participants|||Number
126322|NCT00586469|Secondary|Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains|The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)|At Days 0 and 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Titer||95% Confidence Interval|Geometric Mean
126323|NCT00586469|Primary|Geometric Mean Titers (GMTs) of Anti-H3 and B Strains|GMTs for H1 strain is addressed as a secondary endpoint|At Day 21|Analysis was performed on the According-To-Protocol cohort for immunogenicity, including subjects for whom results were available for that particular timepoint and who were not eliminated due to exclusion criteria.||Titer||95% Confidence Interval|Geometric Mean
126324|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are NEU, PLA, RBC and WBC.|At Month 10 and Month 12|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126325|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~The parameter presented in this table is alanine aminotransferase (ALAT)."|At Day 7, at Months 1, 2, 4, 6 and 7|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126326|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are eosinophils (EOS), basophils (BAS) and creatinine (CREA)."|At Day 7, at Months 1, 2, 4, 6 and 7|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126327|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are lymphocytes (LYM) and monocytes (MON)."|At Day 7, at Months 1, 2, 4, 6 and 7|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126328|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are white blood cells (WBC) and neutrophils (NEU)."|At Day 7, at Months 1, 2, 4, 6 and 7|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126339|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.|CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1 2 = Mild HIV-associated symptoms = WHO clinical stage 2 3 = Advanced HIV-associated symptoms = WHO clinical stage 3 4 = Severe HIV-associated symptoms = WHO clinical stage 4|At Month 10 and Month 12.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||subjects|||Number
126329|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA).~For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).~Parameters presented in this table are red blood cells (RBC) and platelets (PLA)."|At Day 7, at Months 1, 2, 4, 6 and 7|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126330|NCT00586339|Primary|Cell Mediated Immune Response (CMI) (B-cell and T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS).|The CMI response is the measure of the cytokines production (i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)) by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining assay. The results were expressed as a frequency of positive CD4 or CD8 T cell producing at least 1 cytokine within the CD4 or CD8 T cell sub-population. All doubles= T cell expressing at least 2 cytokines. The CMI analyses for B-cell response were not performed due to a technical issue.|At Months 0, 2, 7 and 12.|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||cells||Inter-Quartile Range|Geometric Mean
126331|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies.|"Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.~The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18"|At Month 12.|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
126332|NCT00586339|Primary|Concentrations for HPV-16 and HPV-18 Antibodies.|"Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.~The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18."|At Months 0, 2 and 7.|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
126333|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.|"Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.~A seronegative subject was a subject whose antibody titres are below the cut-off value.~Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus."|At Month 12|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||subjects|||Number
126334|NCT00586339|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.|"Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.~A seronegative subject was a subject whose antibody titres are below the cut-off value.~Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus."|At Months 2 and 7|The According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.||Subjects|||Number
126335|NCT00586339|Primary|HIV Viral Load at Each Time Point in All HIV+ Subjects.|The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per millilitre.|At Month 10 and Month 12|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||RNA copies/mL (in log10)||Inter-Quartile Range|Median
126336|NCT00586339|Primary|HIV Viral Load at Each Time Point in All HIV+ Subjects.|The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per millilitre.|At pre-vaccination and at Months 1, 2, 4, 6 and 7.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||RNA copies/mL (in log10)||Inter-Quartile Range|Median
126337|NCT00586339|Primary|Number of CD4+ Cells Per Cubic Millimetre at Each Time Point in All HIV+ Subjects.||At Month 10 and Month 12|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||cells/mm^3||Inter-Quartile Range|Median
126338|NCT00586339|Primary|Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects.||At pre-vaccination and at Months 1, 2, 4, 6 and 7.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||cells/mm^3||Inter-Quartile Range|Median
126368|NCT00586105|Secondary|Time to Objective Response|Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.|Time from start of study medication to first documented PR or CR up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. Time to objective response was determined on the 5 subjects who had a PR.||months||Full Range|Median
126340|NCT00586339|Primary|Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.|"CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3.~WHO classification of HIV-associated clinical disease:~= Asymptomatic HIV-associated symptoms = WHO clinical stage 1~= Mild HIV-associated symptoms = WHO clinical stage 2~= Advanced HIV-associated symptoms = WHO clinical stage 3~= Severe HIV-associated symptoms = WHO clinical stage 4"|At Months 1, 2, 4, 6 and 7.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126341|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are ALAT, BAS, CREA, EOS, Hct, Hgb, LYM and MON.|At month 10 and month12.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||subjects|||Number
126342|NCT00586339|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated). Parameters presented in this table are haemoglobin (Hgb) and haematocrit (Hct).|At Day 7, at Months 1, 2, 4, 6 and 7|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126343|NCT00586339|Primary|Number of Subjects With Pregnancies and Their Outcome.|Pregnancy outcome with live infant having no apparent congenital anomaly.|Up to Month 12.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||subjects|||Number
126344|NCT00586339|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Up to Month 12.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||subjects|||Number
126345|NCT00586339|Primary|Number of Subjects With Medically Significant Conditions.|"Medically significant conditions were collected regardless of causal relationship to vaccination and intensity.~Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases."|Up to Month 12.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||subjects|||Number
126346|NCT00586339|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Up to Month 7.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126347|NCT00586339|Primary|Number of Subjects With Medically Significant Conditions.|"Medically significant conditions were collected regardless of causal relationship to vaccination and intensity.~Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases."|Up to Month 7.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126348|NCT00586339|Primary|Number of Subjects Reporting Severe (Grade 3) Unsolicited Symptoms.|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Grade 3= event that prevented normal activity."|Within 30 days (Days 0-29) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||subjects|||Number
126349|NCT00586339|Primary|Number of Subjects Reporting Any and Related Unsolicited Symptoms.|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Related = event assessed by the investigator as causally related to the study vaccination."|Within 30 days (Days 0-29) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126350|NCT00586339|Primary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C).~Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship.~Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination."|Within 7 days (Days 0-6) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126351|NCT00586339|Primary|Number of Subjects Reporting Severe (Grade 3) Solicited Local Symptoms.|Grade 3 swelling was greater than 50 millimeter (mm) i.e. >50 mm and grade 3 pain was pain that prevented normal everyday activities.|Within 7 days (Days 0-6) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||subjects|||Number
126450|NCT00584831|Primary|Visual Acuity After Superior-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion|||LogMAR units||Standard Deviation|Mean
126352|NCT00586339|Primary|Number of Subjects Reporting Any Solicited Local Symptoms.|"Solicited local symptoms assessed were pain and swelling. Any = incidence of a particular symptom regardless of intensity grade. Solicited adverse events (AEs) = symptom to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.~Solicited local symptoms were assessed as related to the study vaccination."|Within 7 days (Days 0-6) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
126353|NCT00586326|Secondary|Cosmetic Evaluations Over Time|As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint|At 5 Years|Subjects with Cosmetic Evaluation at 5 Years||percentage of subjects|||Number
126354|NCT00586326|Secondary|Disease Free Survival||At 5 Years|||participants||95% Confidence Interval|Number
126355|NCT00586326|Secondary|Cause Specific Survival||At 5 Years|||participants||95% Confidence Interval|Number
126356|NCT00586326|Secondary|Overall Survival||At 5 Years|||participants||95% Confidence Interval|Number
126357|NCT00586326|Primary|Local Control Rate for Follow-up Period of 5 Years.|Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.|Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.|||percentage of subjects|||Number
126358|NCT00586313|Secondary|The Number of Procedural Complications|Major procedural complications could include: hospitalization, surgery or a radiologic procedure to correct an adverse event; bleeding, infection. Minor procedural complications could be increase in abdominal pain, self-limited hypoxia, bradycardia, tachycardia, hypo or hyper-tension, change in vital signs.|24 months|||complications|||Number
126359|NCT00586313|Primary|Median Total Specimen Length|Median Total Specimen Length grouped for indication for liver biopsy: Suspected NAFLD, Intrahepatic Cholestasis, Exclusion of Cirrhosis, Increased Liver Function Tests (LFTs) of Uncertain Cause and the Total.|24 months|||mm||Full Range|Median
126360|NCT00586261|Primary|Change in Brachial Arterial Reactivity|Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient’s right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.|After 6 months of treatment|The study was stopped early due to low recruitment and no evidence of an effect in this analysis.||mm||Standard Error|Mean
126361|NCT00586196|Secondary|Change From Baseline and MDAS Scores Over Time|Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe.|Baseline, hospital discharge, weeks 2, 4 and 6|Based on ability to recruit||units on a scale||Standard Deviation|Mean
126362|NCT00586196|Primary|Percentage of Participants With Delirium Using the CAM Over Time|Confusion Assessment Method (CAM)—Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.|Baseline, hospital interviews, weeks 2, 4 and 6|||percentage of participants|||Number
126363|NCT00586170|Secondary|Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)||24 Weeks|No AOFAS, Foot Function Index, or SF-36 Health Survey data was collected or analyzed.|||||
126364|NCT00586170|Primary|Percentage of Successful 5th Metatarsal Unions Achieved.|Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing.|24 Weeks|Each patient had 1 fracture. The number of fractures treated equals the number of patients treated in both treatment groups.||percentage of fractures healed|Participants||Number
126365|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks|||Units on a scale||Standard Deviation|Mean
126366|NCT00586157|Secondary|Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires|"The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.~Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88"|Baseline and 4 weeks|||Units on a scale||Standard Deviation|Mean
126367|NCT00586157|Primary|Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day.|Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).|Baseline and 4 weeks|||Units on a scale||Standard Deviation|Mean
126393|NCT00585637|Secondary|Change in sTNF-R2 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker sTNF-R2 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||pg/mL||Inter-Quartile Range|Median
126369|NCT00586105|Secondary|Overall Response Duration|Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.|From PR or CR to progression or death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug. The overall response duration was determined on the 5 subjects who had a PR.||months||Full Range|Median
126370|NCT00586105|Secondary|Overall Best Response|The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD. Tumor response was evaluated using RECIST. PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute PD. In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|Best response observed from start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||participants|||Number
126371|NCT00586105|Secondary|Disease Control (DC)|The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target). PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD. SD: steady state of disease; do not qualify for PR or progressive disease (PD).|From start to end of study medication up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||participants|||Number
126372|NCT00586105|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical. Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||months||95% Confidence Interval|Median
126373|NCT00586105|Secondary|Overall Survival (OS)|Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause. Survival time for subjects still alive at the time of analysis was censored at the date of last contact.|Time from start of therapy to death up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||months||Full Range|Median
126374|NCT00586105|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier. Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.|Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months|All subjects who received at least 1 dose of drug (the intent to treat [ITT] population) were included in the analysis. Thirty-nine patients received at least 1 dose of drug.||months||95% Confidence Interval|Median
126375|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed. The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)].|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.||Kg/L||Standard Deviation|Mean
126376|NCT00586105|Primary|Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)|Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed. Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.|12 hours after at least 21 days of uninterrupted dosing|A full PK profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted BID dosing.||mg/L||Standard Deviation|Mean
126377|NCT00586105|Primary|Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])|The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose. The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]).|12 hours after at least 21 days of uninterrupted dosing|A full pharmacokinetics (PK) profile was obtained in 32 of the 39 patients after at least 21 days of uninterrupted twice daily (BID) dosing.||mg*hour/Liter||Standard Deviation|Mean
126378|NCT00585975|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses|Day 1|||Participant|||Number
126379|NCT00585975|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|||Participant|||Number
126380|NCT00585923|Secondary|Level of Function (Neck Disability Index)|Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit.|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
126394|NCT00585637|Secondary|Change in IL-10 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-10 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||pg/mL||Inter-Quartile Range|Median
126381|NCT00585923|Secondary|Neurological Status Change in Neurological Status Since Surgery.|Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
126382|NCT00585923|Secondary|Pain With Activity|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score."|Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
126383|NCT00585923|Secondary|Pain at Rest|"Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100."|Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|||Participants|||Number
126384|NCT00585923|Primary|Fusion Success|"The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views.~Fusion Grading~fused”~probably fused”~pseudarthrosis”~This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused."|Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)|Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study||participants|||Number
126385|NCT00585910|Secondary|Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders|Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients.|7 weeks|||Units on a Scale||Full Range|Mean
126386|NCT00585910|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)|The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).|7 weeks|All analyses were intent to treat, with last observation carried forward.||Units on a Scale||Standard Deviation|Mean
126387|NCT00585715|Primary|Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.|"At the 6 month follow-up, a blinded assessor ranked change in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change.~Using this scale, the average reduction in cellulite appearance was calculated for each participant that experienced a mild to moderate reduction in cellulite appearance."|6 month follow up|The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance.||units on a scale||Standard Deviation|Mean
126388|NCT00585715|Secondary|Safety and Efficacy of Laser With and Without Cooling||Laser Treatments x3 and at 1, 3 and 6 month follow up||||||
126389|NCT00585715|Primary|Number of Participants With Mild to Moderate Reduction in Cellulite.|"Nurnberger-Muller Scale :~Stage 0: No dimpling. Stage 1: No dimpling. Stage 2: Dimpling spontaneously standing. Stage 3: Dimpling spontaneously standing and lying down.~Texture Scale:~Hard or Solid: Pinch test firm folds and furrows. Adherent to deep planes. Not modified with lying versus standing position.~Soft or Flaccid: Pinch test spongy and floating folds and furrows. No adherence to deep planes. Not painful, flaccid. Orange peel skin appears spontaneously.~Edematous: Doughy consistency. Pain and cramps. Signs of venous and lymphatic insufficiency legs in boot/column.~At the 6month follow-up, a blinded assessor ranked changes in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change. Improvement in cellulite appearance was characterized by an increase of one unit or more on this scale."|6 month follow up|Only subjects who completed the 6 month follow-up were included in the analysis||participants|||Number
126390|NCT00585689|Primary|Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment|The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.|63 days (post 3 cycles)|29 patients were enrolled. 26 of the 29 patients received the planned 3 cycles. 22 of the 26 patients had a cystectomy and were evaluable for the primary endpoint.||percentage of patients||95% Confidence Interval|Number
126391|NCT00585650|Primary|The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks|Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4.. The sum of all three severity parameters is then calculated based on surface area affected.|Week 12|Intention to treat||participants|||Number
126392|NCT00585637|Secondary|Change in CRP From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker CRP from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||mg/L||Inter-Quartile Range|Median
126395|NCT00585637|Secondary|Change in IL-6 From 0 to 3 Months.|Examine the influence of oral vitamin D supplementation on inflammatory marker IL-6 from baseline to the 3 month follow-up.|From baseline to 3 months|Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.||pg/mL||Inter-Quartile Range|Median
126396|NCT00585637|Primary|Levels of Plasma 25(OH)D at Baseline, 3 Months and 6 Months.|Among Blacks, identify a dose of oral vitamin D supplementation that will result in levels of plasma 25(OH)D that would be predicted to reduce colorectal cancer incidence. Community-based African Americans drawn from the Open Doors to Health, which is a colorectal cancer prevention study in 1554 subjects from 12 public-housing communities and community- and faith-based organizations in Boston.|Baseline, 3months, 6months|Number of participants analyzed above is for baseline. At 3 months, number of participants analyzed was: 71 (no vitamin D), 67 (1000 IU Vitamin D), 76 (2000 IU Vitamin D) and 78 (4000 IU Vitamin D). At 6 months, number of participants analyzed was: 75 (no vitamin D), 68 (1000 IU Vitamin D), 72 (2000 IU Vitamin D) and 77 (4000 IU Vitamin D).||ng/mL||Inter-Quartile Range|Median
126397|NCT00585533|Secondary|Overall Survival|Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.|24 months|||weeks||95% Confidence Interval|Median
126398|NCT00585533|Primary|Survival Rate at 6-months Chemotherapy-progression-free (CP-free)|Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.|6 months|||percentage of participants|||Number
126399|NCT00585494|Secondary|Prevalence of Adverse Outcomes in the Hyperglycemic Elective Orthopedic Population.||1 year||||||
126400|NCT00585494|Secondary|Prevalence of Undiagnosed Diabetes in the Elective Orthopedic Population.||1 year||||||
126401|NCT00585494|Primary|Prevalence of Hyperglycemia in the Elective Orthopedic Population|Number of orthopedic patients that have elevated fasting blood glucose levels preoperatively|1 year|||patients|||Number
126402|NCT00585468|Primary|Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||mcg*h/mL||Standard Deviation|Mean
126403|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||hours||Full Range|Median
126404|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
126405|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
126406|NCT00585468|Primary|Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)|0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||mcg*h/mL||Standard Deviation|Mean
126407|NCT00585468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||hours||Full Range|Median
126408|NCT00585468|Primary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
126409|NCT00585468|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA)||0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|||micrograms per milliliter||Standard Deviation|Mean
126410|NCT00585377|Secondary|Evaluation of Response Rate|The percentage of patients in which response (CR + PR) was observed: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|2 years|||percentage of participants||95% Confidence Interval|Number
126411|NCT00585377|Secondary|Evaluation of Progression-free Survival|The length of time during and after bevacizumab-erlotinib that a patient lives with the disease but does not progress according to RECIST 1.0 Criteria. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions|2 years|||weeks||95% Confidence Interval|Median
126412|NCT00585377|Primary|Evaluation of Overall Survival|The length of time from the start of treatment for a disease that patients are still alive.|2 years|All patients were included in response assessment based on intention to treat including those who received less than 6 weeks of therapy||weeks||95% Confidence Interval|Median
126413|NCT00585351|Secondary|Prevention of Chemical Pneumonitis|Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).|Assessed on the day of discharge (average length of stay is approximately 3-7 days)|Intention to treat analysis for secondary outcome (number of participants with aspiration pneumonia).||Participants|||Number
126414|NCT00585351|Primary|The Benefit of Advanced Notification in Promoting Informed Consent|Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).|Assessed at time of enrollment into the study.|Intention to treat analysis for primary outcome (number of patients consented).||Participants|||Number
126415|NCT00585312|Secondary|Colorectal Polyp Burden|"The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively.~Weighted colorectal polyp burden over Years 1 – 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.||mm||Standard Deviation|Mean
126447|NCT00584909|Primary|Disease-free Survival|Number of months of survival with no evidence of disease|4 years - Median follow up time of 45.3 months|||months||Full Range|Median
126448|NCT00584857|Secondary|Toxicity|Toxicity secondary to paclitaxel, carboplatin, and megesterol acetate based on NCI common toxicity criteria|3 years|||participants|||Number
126416|NCT00585312|Secondary|Total Number of Colorectal Polyps|"Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively.~Weighted total number of colorectal polyps over Years 1 – 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study."|Years 1 - 5|ITT population (N: 106) consisted of all participants who were randomized and assigned to a treatment. Study was early terminated due to low enrollment and lower than expected endpoint rate and no analysis was performed.||polyps||Standard Deviation|Mean
126417|NCT00585312|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:~Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps), or~Diagnosis of colorectal malignancy (ColMal), or~Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Secondary outcome measure was met by 14 (Polyp:7,ColMal:0,DO:14) participants in the Celecoxib and 14 (13,0,12) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.||years||Standard Deviation|Mean
126418|NCT00585312|Primary|Time to Disease Progression|"Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:~Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or~Diagnosis of colorectal malignancy (ColMal)."|5 years|ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Primary outcome measure was met by 7 (Polyp:7,ColMal:0) participants in the Celecoxib group and 13 (13,0) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.||years||Standard Deviation|Mean
126419|NCT00585286|Secondary|Pain Tolerance|"The average pain score reported over all three treatments was 5.67, corresponding to moderate pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being no pain and 10 being worst pain imaginable. All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy."|At treatment visit (up to 3 visits)|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Mean
126420|NCT00585286|Primary|Degree of Atrophy|Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Median
126421|NCT00585286|Primary|Average Improvement in Surface Texture|Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Median
126422|NCT00585286|Primary|Overall Improvement of Acne Scarring|Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1–25% improvement; 2: 26–50%; 3: 51–75%; 4: 76–100% improvement).|Baseline, 1 month and 3 months post-treatment|Out of 15 subjects enrolled at our site, one was lost to follow up before the 3 month follow up for the first treatment. Therefore, data was analyzed for the 14 patients that completed the study.||units on a scale||Standard Deviation|Mean
126423|NCT00585221|Primary|Time to Progression (TTP).||two years||||||
126424|NCT00585221|Primary|Decrease in Tumor Size.|Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).|18 months||||||
126425|NCT00585182|Secondary|Clinically Relevant Bleeding||Through hospitalization|||# events|||Number
126426|NCT00585182|Primary|Peak Low Molecular Weight Heparin Anti-Xa Activity Level.|The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL|Day 2|||IU/mL||Standard Deviation|Mean
126427|NCT00585169|Primary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|The PGYBOCS is a reliable & valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.|Baseline to study end point (10 weeks)|All participants who completed at least one study visit were included in the analysis.||units on a scale||Standard Deviation|Mean
126449|NCT00584857|Primary|3-year Overall Survival|Number of subjects alive at 3 years|3 years - median followup of 40.4 months|||partipants|||Number
126481|NCT00583947|Primary|Mean Serum Glucose Values||Predose, 2 and 6 hours post dose 1|Intent to treat population||mg/dl||Standard Deviation|Mean
126428|NCT00585104|Primary|Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.|Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.|From baseline to 30-minutes after levosimendan started.|Ten patients were enrolled. Complete data was available in 6 patients. The primary endpoint was change in left ventricular end diastolic pressure (LVEDP) from baseline to 30-minutes after starting levosimendan. An Intent to Treat (ITT) analysis was performed.||mmHg||Standard Deviation|Mean
126429|NCT00585039|Secondary|Clinical Asthma Score (CAS)|Change in clinical asthma score while in ED. 15 point clinical asthma score. Score ranges from 5 (no to mild respiratory distress) to a maximum of 15 (severe respiratory distress).|4 hours|analysis per protocol||units on a scale||95% Confidence Interval|Mean
126430|NCT00585039|Primary|Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec||Baseline and 4 hours|Enrollment period ended prior to final goal sample size. ITT.||L/sec||95% Confidence Interval|Mean
126431|NCT00585013|Secondary|Incidence of Methhemoglobin >5%, Gene Expression Profiles, and S100B.||48 hours|Data not collected for these assessments|||||
126432|NCT00585013|Primary|Ischemic Injury as Measured by Lactate Levels|Lactate levels correlate to ischemic injury. Higher values represent more injury.|48 hours|||mmol/L||Standard Deviation|Mean
126433|NCT00585013|Primary|Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels|BNP levels correlate to ventricular and myocardial performance, function, and strain. Higher values represent greater strain and decreased function.|48 hours|||pg/dL||Standard Deviation|Mean
126434|NCT00585013|Primary|Myocardial Injury|Troponin levels correlate with myocardial injury. Greater troponin levels represent greater myocardial injury|48 hours|||ng/mL||Standard Deviation|Mean
126435|NCT00585013|Primary|Serum Inflammatory Mediators Post CPB|Inflammation measured through the measurement inflammatory mediators, serum interleukin-6, serum interleukin-8, and tumor necrosis factor. Baseline (preoperative, 0h, 12h, 24h, and 48h.|48 hours|||ng/mL||Standard Deviation|Mean
126436|NCT00584987|Secondary|Total NPIF|Nasal peak inspiratory flow (NPIF) is a physiological measure of nasal airflow which is particularly sensitive to nasal valve collapse. NPIF was measured objectively in liters per minute with an In-Check Peak Inspiratory FlowMeter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and recorded the best flow measured. The morning and evening NPIF measurements were summed for days 2 through 28 of the treatment cycle, yielding the total NPIF outcome measure. NPIF scores increase with air flow quality (i.e., higher NPIF values are indicative of better nasal air flow).|days 2 through 28 of the treatment cycle|||liters per minute||Full Range|Median
126437|NCT00584987|Secondary|RQLQ Score [6 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 6 weeks after initiation of treatment regimen|||units on a scale||Standard Error|Mean
126438|NCT00584987|Secondary|RQLQ Score [4 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 4 weeks after initiation of treatment regimen|||units on a scale||Standard Error|Mean
126439|NCT00584987|Secondary|RQLQ Score [2 Weeks]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed 2 weeks after initiation of treatment regimen|||units on a scale||Standard Error|Mean
126440|NCT00584987|Secondary|RQLQ Score [Baseline]|The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|assessed at baseline|||units on a scale||Standard Error|Mean
126441|NCT00584987|Primary|Total Nasal Congestion Symptom Score|The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).|28 days of treatment|||units on a scale||Full Range|Median
126442|NCT00584935|Secondary|2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks||24 weeks||||||
126443|NCT00584935|Secondary|1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks||16 weeks||||||
126444|NCT00584935|Primary|2. The Proportion of Patients That Experience a Grade 3, Grade 4, or Grade 5 Toxicity Based Reaction on the NCI-CTC System at the Time of Their Infusions and During Follow-up Visits.||16 weeks||||||
126445|NCT00584935|Primary|Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks|"Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth)~0-25%~25-50%~50-75%~75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by sympblephara and n is the number of symblephara countable)~a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe"|16 weeks|||participants|||Number
126446|NCT00584909|Secondary|Toxicity|Toxicity secondary to paclitaxel and carboplatin based upon the NCI common toxicity criteria version|4 years|||participants|||Number
126451|NCT00584831|Primary|Visual Acuity After Superior-temporal Version Movement|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion|||LogMAR units||Standard Deviation|Mean
126452|NCT00584831|Primary|Visual Acuity After Infero-nasal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after lens insertion|||LogMAR units||Standard Deviation|Mean
126453|NCT00584831|Primary|Visual Acuity After Infero-temporal Version Movement.|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|10 minutes after insertion|||LogMAR units||Standard Deviation|Mean
126454|NCT00584740|Primary|Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|6 weeks|Safety Analysis Set: the safety set included all participants.||score on a scale||Standard Deviation|Mean
126455|NCT00584740|Secondary|Percentage of Participants Maintaining Remission|Remission was defined as CDAI < 150 points.|10 weeks|The analysis population included participants of the safety set who achieved remission.||Percentage of participants|||Number
126456|NCT00584740|Secondary|Area Under CDAI Curve|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.|10 weeks|Safety Analysis Set: the safety set included all participants.||Units on a scale*day||Standard Error|Least Squares Mean
126457|NCT00584740|Secondary|Mean Change From Baseline in CDAI Score|The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.|baseline, 2 weeks, 4 weeks|Safety Analysis Set: the safety set included all participants.||score on a scale||Standard Deviation|Mean
126458|NCT00584740|Secondary|Percentage of Participants Achieving Response|Response was defined as CDAI reduction of at least 70 points from baseline.|6 weeks|Safety Analysis Set: the safety set included all participants.||Percentage of participants|||Number
126459|NCT00584740|Secondary|Percentage of Participants Achieving Remission|Remission was defined as CDAI < 150 points.|6 weeks|Safety Analysis Set: the safety set included all participants.||Percentage of participants|||Number
126460|NCT00584740|Secondary|Percentage of Participants Achieving Remission and/or Response|Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.|6 weeks|Safety Analysis Set: the safety set included all participants.||Percentage of participants|||Number
126461|NCT00584727|Primary|Patient Preference|This outcome measures which lens the subjects preferred to wear.|end of study|Analysis includes participants who completed the study per protocol (n=88)||Number of participants|||Number
126462|NCT00584727|Primary|Patient Reported Comfort.|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)||Scores on a scale||Standard Error|Least Squares Mean
126463|NCT00584727|Primary|Lens Stability Within 5 Degrees|Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)||degrees|||Number
126464|NCT00584727|Primary|Lens Orientation Within 5 Degrees|Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.|1 minute|Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)||degrees|||Number
126465|NCT00584727|Primary|Patient Reported Vision|A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision.|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88)||Scores on a scale||Standard Error|Least Squares Mean
126466|NCT00584727|Primary|Visual Acuity|Number of eyes with Distance Visual Acuity 20/20 or better|15-20 minutes|Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes)||Eyes with Snellen VA 20/20 or better|||Number
126959|NCT00578812|Secondary|Worst Arm Pain Visual Analog Scale|Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.|24 Months|Per protocol||participants|||Number
126467|NCT00584701|Secondary|Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I|"Affymetrix GeneChip Human Exon 1.0 ST Arrays (Affymetrix, Santa Clara, CA, USA) were used to obtain gene expression values. Raw data (Affymetrix.CEL files) was imported into Partek Genomics Suite 6.4 (Partek, St Louis, MO, USA). Probe summarization and probe set normalization were performed using robust multichip average, which included background correction, quantile normalization, log2 transformation and median polish probe set summarization.~Exons in genes correlated with percentage improvement on the Aberrant Behavior Checklist Irritability subscale were identified."|Baseline, 8 Weeks|||Number of Correlated Genes|||Number
126468|NCT00584701|Primary|Percent Change of ABC - Irritability Subscale Score|"Aberrant Behavior Checklist-Irritability (ABC-I)subscale: measure of assessing changes in symptoms of irritability in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. There are 45 items that are rated on a 4-point scale from “no problem” to “major problem. ABC-I scores ranges from 0 (best) to 45 (worst). A negative change signifies improvement.~We measured percent change of ABC-I scores from 8 weeks after risperidone treatment compared to baseline."|Baseline, 8 weeks|||percent change in scores||Full Range|Mean
126469|NCT00584480|Primary|Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score|Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.|Baseline, 8 Weeks from baseline, and 20 Weeks from baseline|||participants|||Number
126470|NCT00584415|Secondary|Total Number of Significant Ablation Procedure Related Complications|Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.|0-1 year|||Complications|||Number
126471|NCT00584415|Primary|Atrial Tachyarrhythmia Recurrence in Participants|Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.|0-5 years|all patients referred for paroxysmal AF ablation between 1-2004 and 12-2005 were included||participants|||Number
126472|NCT00584220|Primary|Subject Reported Lens Comfort.|A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is >0 indicates comfortable and <0 indicates uncomfortable.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.||Units on a scale||Standard Deviation|Least Squares Mean
126473|NCT00584220|Primary|Subjective Reported Vision|A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score >0 then greater vision, if <0 then lesser vision.|1 week|Analysis includes only participants who completed the study per protocol and had no missing data.||Units on a scale||Standard Deviation|Least Squares Mean
126474|NCT00584077|Secondary|to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year||15-20 minutes||||||
126475|NCT00584077|Primary|Evaluate the Presence and Strength of the Cough Reflex in the Lower Airway|Presence of cough as elicited by placement of biopsy forceps or instillation of dextrose solution on the airway mucosa. The presence of the cough reflex will be assessed with administartion of mecahnical (Biopsy foreceps) and chemical (dextrose solution) at the level of the main carina, native lung airway and proximal and distal to the airway anastomosis.|15-20 minutes|||coughs||Standard Deviation|Mean
126476|NCT00583947|Secondary|Plasma Concentration of (R,R) Formoterol|If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero.|predose, various postdose times|PK population consisted of subjects who were in the intent-to-treat population and had any plasma concentration data available.||picogram/milliliter||Standard Deviation|Mean
126477|NCT00583947|Secondary|Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.||liters/second||Standard Deviation|Mean
126478|NCT00583947|Secondary|Mean Peak Expiratory Flow Rate (PEFR)|PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.||liters/second||Standard Deviation|Mean
126479|NCT00583947|Secondary|Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit.|predose, various postdose timepoints|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses||liters||Standard Deviation|Mean
126480|NCT00583947|Primary|Change From Predose in Mean Serum Glucose|Change in mean serum glucose at the specified timepoint minus the predose value.|predose, 2 and 6 hours post dose|Intent to treat population||mg/dl||Standard Deviation|Mean
126484|NCT00583947|Primary|Change From Predose in Mean Diastolic Blood Pressure|Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
126485|NCT00583947|Primary|Mean Diastolic Blood Pressure|Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
126486|NCT00583947|Primary|Change From Predose in Mean Systolic Blood Pressure|Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
126487|NCT00583947|Primary|Mean Systolic Blood Pressure|Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population||mmHg||Standard Deviation|Mean
126488|NCT00583947|Primary|Change From Predose in Mean Heart Rate|Heart rate measured at various timepoints minus the heart rate at predose.|predose, various timeframes up to 5 hours post last dose|Intent to treat population||beats per minute||Standard Deviation|Mean
126489|NCT00583947|Secondary|Mean Forced Expiratory Volume in One Second(FEV1)|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer.|predose, various postdose times|Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses.||liters||Standard Deviation|Mean
126490|NCT00583947|Primary|Mean Heart Rate|Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).|predose, various timeframes up to 5 hours post last dose|Intent to treat population||beats per minute||Standard Deviation|Mean
126491|NCT00583908|Secondary|Degree of Lens Rotation in Inferior Gaze.|Degree of lens rotation while participant is gazing down.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||Degree of rotation||Standard Deviation|Mean
126492|NCT00583908|Secondary|Degree of Lens Rotation in Inferior-nasal Gaze.|Degree of lens rotation while participant is gazing down and in.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||Degree of rotation||Standard Deviation|Mean
126493|NCT00583908|Secondary|Degree of Lens Rotation Inferior-temporal Gaze.|Degree of lens rotation while participant is gazing down and out.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||Degree of rotation||Standard Deviation|Mean
126494|NCT00583908|Secondary|Degree of Lens Rotation in Nasal Gaze.|Degree of lens rotation while participant is gazing in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
126495|NCT00583908|Secondary|Degree of Lens Rotation in Temporal Gaze.|Degree of lens rotation while participant is gazing out(towards the temple).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
126496|NCT00583908|Secondary|Degree of Lens Rotation in Superior-nasal Gaze.|Degree of lens rotation while participant is gazing up and in(towards the nose).|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
126497|NCT00583908|Secondary|Degree of Lens Rotation in Superior-temporal Gaze.|Degree of lens rotation while participant is gazing up and out(towards the temple).|After each of 4 lens insertions.,|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
126498|NCT00583908|Secondary|Degree of Lens Rotation in Superior Gaze.|Degree of lens rotation while participant is gazing up.|After each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
126499|NCT00583908|Primary|Visual Acuity During Head Tilt|"logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity.~logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal."|after each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some of the lenses.||logMAR units||Standard Deviation|Mean
126500|NCT00583908|Primary|Lens Orientation During Head Tilt.|Degree of lens rotation on the eye with the head tilted.|after fit of each of the four lens insertions|Only participants who completed the study per protocol. Some participants had missing data for some lenses.||Degree of rotation||Standard Deviation|Mean
126501|NCT00583713|Primary|Elimination Rate Constant||1 day|||1/hr||Standard Deviation|Mean
126502|NCT00583713|Primary|Area Under the Curve for the 24-hour Dosing Interval||1 day|||µmol*hr/L||Standard Deviation|Mean
126503|NCT00583713|Primary|Terminal Half-life||1 day|||hours||Standard Deviation|Mean
126504|NCT00583713|Primary|Time to Maximum Concentration||1 day|||hours||Standard Deviation|Mean
126505|NCT00583713|Secondary|Urinary Sulfate Concentration||pre-dose to 6 days post-dose|||mg/dL||Standard Deviation|Mean
126506|NCT00583713|Primary|Maximum Observed Concentration (Cmax)||1 day|||µmol/L||Standard Deviation|Mean
126594|NCT00582426|Secondary|Percentage of Patients Hospitalized Due to Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of patients|||Number
126507|NCT00583700|Secondary|Tissue Compliance|"Tissue compliance meter measurements of the treated breast compared to the non-treated breast were obtained at 18 months post-radiation therapy. Tissue compliance simply means how soft and pliable the breast tissue is when force is applied to it.~One physician would hold the tissue compliance meter (TCM) against the participant's skin. A standard amount of force would be applied. A second physician would read the displacement scale for a specific set of areas on the breast. The range of the scale was 0 to 60 milimeters (mm). The physician's were blineded to the participant's intervention at the time of measurement.~The final value is the difference between the untreated and the treated breast [untreated - treated]. The range of these differences was -3.3 to 7.0 mm."|18 months post-treatment|All study participants enrolled were to be measured at 18 months post-radiotherapy. The number of participants analyzed varied by the number compliant with study schedule.||milimeters (mm)||Standard Deviation|Mean
126508|NCT00583700|Primary|Subjective, Objective, Management, and Analytic (SOMA) Score|A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.|18 month post-treatment|All participants enrolled in the study were evaluated for SOMA scores. Numbers varied by study participants compliance with follow-up appointments.||units on a scale||Standard Deviation|Mean
126509|NCT00583661|Primary|Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.|Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.|Participants were followed while on device support, an average of 58 days|All subjects implanted with the device were included in this analysis.||participants|||Number
126510|NCT00583661|Primary|The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.|The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.|Participants were followed while on device support, an average of 58 days|All 48 participants were included in the analysis. Adverse Events for each participant was counted and the total number of events was divided by the total time the Cohort's subjects were supported on device. A 95% Poisson confidence interval was calculated around the point estimates.||Events per patient-day||95% Confidence Interval|Number
126511|NCT00583622|Secondary|Participant Response|Number of participants evaluated using Response to Treatment in Solid Tumors (RECIST) with definitions of Complete Response (CR): disappearance of all target lesions; and, Partial Response: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Maintained Continued CR: participants who entered study in a CR and maintained CR post study treatment. Evaluations once a week till Day +30, then Days 30, 60, and 100 then at 6 months or until disease progression.|Up to 6 months|One participant was not evaluable for response as participant expired prior to performing restaging evaluation.||percentage of participants|||Number
126512|NCT00583622|Primary|Event-Free (EF) Rate|Percent of participants free of relapse or disease progression at end of 6 months. Event-free survival estimated from the first day of High-dose chemotherapy (day-6) until tumor progression, relapse, or death from any cause.|Up to 6 Months|Due to the small number of patients treated, 12 out of 30 planned, an analysis was not possible.|||||
126513|NCT00583596|Primary|Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure|The number of participants with a residual shunt (efficacy)|Long term follow up data captured at 5, 6 or 7 years post implant|Of the 152 subjects that completed long term follow-up, 128 subjects underwent Transthoracic echocardiogram (TTE) at their final visit.||participants|||Number
126514|NCT00583596|Primary|Reporting of Late Adverse Events Relating to the Device.||Long term follow up for data captured at 5, 6 or 7 years post implant|152 subjects of the 436 subjects eligible for post market survelliance completed a 5, 6 or 7 year follow-up.||participant|||Number
126515|NCT00583557|Secondary|The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).|NOT ANALYZED|up to 5 Years||||||
126516|NCT00583557|Primary|To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.|SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.|Up to 5 years|||Particpants|||Number
126517|NCT00583492|Secondary|Decrease in Quality of Life|Quality of Life was measured using the comprehensive Expanded Prostate Cancer Index Composite (EPIC) instrument 19 and 20|3 years|||participants|||Number
126518|NCT00583492|Secondary|Disease-specific Survival||10 years|||participants|||Number
126519|NCT00583492|Secondary|Freedom From Distant Metastases||10 years|||participants|||Number
126520|NCT00583492|Secondary|Positive Prostate Biopsy at 2 Years||2 years|||participants|||Number
126521|NCT00583492|Secondary|Acute >= Grade 3 Treatment-related Toxicity|This metric includes both expected and unexpected events Toxicities were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3|90 days|||percentage of adverse events|||Number
126522|NCT00583492|Primary|Freedom From Biochemical/Clinical Failure (FFF)|Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL|5 years|||participants|||Number
126523|NCT00583219|Secondary|Incontinence Impact Questionnaire-short Form (IIQ-7) Scores|The IIQ-7 was one measure of urinary-associated quality of life. The IIQ-7 questionnaire has 7 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 21, a higher score indicating greater distress.|baseline, 1 month, 3 months|||units on a scale||Inter-Quartile Range|Median
126524|NCT00583219|Secondary|Bothersomeness|The bothersomeness refers to the question: On a scale of 1-10 (0 is not at all; 10 is intolerable), how badly does loss of urinary control bother you?|baseline, 1 month, 3 months|||units on a scale||Inter-Quartile Range|Median
126525|NCT00583219|Secondary|Median Urogenital Distress Inventory (UDI-6) Scores|The UDI-6 was one measure of urinary-associated quality of life. The UDI-6 questionnaire has 6 items, scored from 0 (not at all) to 3 (greatly), with total scores ranging from 0 to 18, a higher score indicating greater distress.|baseline, 1 month, 3 months|||units on a scale||Inter-Quartile Range|Median
126802|NCT00580398|Primary|Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.|Number of participants who completed the 12-week follow-up survey and thus the study.|12 weeks|||participants|||Number
126526|NCT00583219|Secondary|Urinary Urgency at 3 Months|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|3 months after treatment|||participants (per category)|||Number
126527|NCT00583219|Secondary|Urinary Urgency at 1 Month|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|1 month after treatment|||participants (per category)|||Number
126528|NCT00583219|Secondary|Urinary Urgency at Baseline|Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of ‘urgency’ at each void. The scale employs the following wording: “Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE – no urgency, 1: MILD – awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE – enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE – extreme urgency discomfort that abruptly stops all activity or tasks.”|baseline|||participants (per category)|||Number
126529|NCT00583219|Secondary|Urine Culture||baseline, 1 month, 3 months|||participants|||Number
126530|NCT00583219|Secondary|Postvoid Residual||baseline, 1 month, 3 months|||mL||Inter-Quartile Range|Median
126531|NCT00583219|Secondary|Mean Number of Pads Per Day||baseline, 1 month, 3 months|||pads per day||Inter-Quartile Range|Mean
126532|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 3 Months|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|3 months after treatment|||participants (per category)|||Number
126533|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at 1 Month|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|1 month after treatment|||participants (per category)|||Number
126534|NCT00583219|Secondary|Blaivas-Groutz Anti-Incontinence Score at Baseline|The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. This score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).|baseline|||participants (per category)|||Number
126535|NCT00583219|Secondary|Median 24 Hour Pad Weight|Prior to baseline and follow-up visits, the study coordinator weighed standard pads provided to the subject for the study time period. The study coordinator instructed the subject to bring in any pads used during the 24-hour period prior to baseline and follow up visits. The study coordinator recorded the 24-hour pad weights into the study dataset.|baseline, 1 month, 3 months|||g||Inter-Quartile Range|Median
126536|NCT00583219|Primary|Median Number of Incontinent Episodes During 24 Hours|The study coordinator instructed the subject to keep record of any incontinence episodes during the 24-hour period prior to their baseline and follow-up visits.|baseline, 1 month, 3 months|||number of incontinent episodes||Inter-Quartile Range|Median
126537|NCT00583115|Secondary|1) Decrease in Pulmonary Artery Pressures and Vascular Resistance as Determined by Cardiac Catheterization, 2) Time to Clinical Worsening,3) Survival.||6 months|The only participant died prior to study completion. Unable to measure pulmonary artery pressure and vascular resistance as only participant died prior to study completion. Unable to measure time to clinical worsening as only participant died. Survival should be counted as 0.|||||
126538|NCT00583115|Primary|1) Safety and Tolerability as Determined by Laboratory Evaluation, Physical Examination, Echocardiographic Analysis, and Adverse Events, and 2) Efficacy as Determined by an Increase in the Non-encouraged 6 Minute Walk Test From Baseline.||6 months|Unable to measure safety and tolerability as the participant died prior to study completion. Laboratory evaluations not able to be measured as participant died. Physical examination, Echocardiographic and adverse events not able to be measured as participant died Unable to measure 6 minute walk test as participant died prior to study completion.|||||
126539|NCT00582972|Secondary|Change in Bone Resorption From Baseline to 1 Month|urine n-telopeptide (normalized to creatinine levels)|change in bone resorption from baseline to 1 month|23 enrolled but two dropped from the study, leading to 21 subjects who completed all study visits||mcg/mmol creatinine||Standard Deviation|Mean
126540|NCT00582972|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent calcium absorption|change in calcium absorption from baseline to 1 month|Subjects completing the measures of calcium absorption were included in the analysis of the primary outcome.||percent calcium absorption||Standard Deviation|Mean
126840|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126541|NCT00582946|Primary|Maximum Effective Sound Pressure Level (MEPO)|A primary outcome measure of interest is an estimate of the insitu maximum equivalent pressure output (MEPO) of the EarLens system, which represents the sound pressure level that would have to be applied at the eardrum (or tympanic membrane) to produce the same degree of tympanic membrane (TM) vibration that the EarLens system produces with the coil current set to its maximum value, and given the anatomical constraints on the coupling between the coil and magnet for a given subject. The target fitting range included hearing loss up to 60 decibels (dB) Hearing Level (HL). In order for the device to be an effective hearing aid for this target population, the maximum output of the device needs to be able to provide output and gain to treat this maximum hearing loss.|1 month|||decibels (dB) Sound Pressure Level (SPL)||Standard Deviation|Mean
126542|NCT00582933|Primary|Death From GVHD|To establish the early transplant-related severe morbidity and mortality and 3-the incidence and severity of GvHD.|2 years|||participants|||Number
126543|NCT00582907|Secondary|To Determine the Differences in the Proportion of Time Subjects Received Rilonacept vs Placebo|"The proportion of time within the trial that participants received rilonacept as opposed to placebo. The reason for this outcome is that participants who had at least 2 attacks within an individual treatment course were able to escape in a blinded manner to the other treatment arm until the end of that treatment course and then resume the original randomization sequence. Thus participants may have been treated for a longer time with one treatment arm or the other."|12 months|Participants who received at least one treatment course of both rilonacept and placebo.||Percentage of time treated||95% Confidence Interval|Number
126544|NCT00582907|Secondary|To Determine the Differences in the FMF Severity Score of the Subjects Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the Armenian Evaluation Score between rilonacept and placebo courses. The Armenian Evaluation Score is a composite score of disease severity based on the frequency, duration and character of attacks (degree of fever and severity of serositis). It was adapted to calculate a score for a 3-month treatment course. The lowest (best) score is 0 and higher values are worse. In theory there is no upper limit to the scale. The total score is reported (there are no subscales).|overall 12 months|Participants who received at least one course each of placebo and rilonacept.||units on a scale||Inter-Quartile Range|Median
126545|NCT00582907|Secondary|To Determine the Differences in the Quality of Life Between the Treatment Arms (Rilonacept vs. Placebo).|Differences in the health-related quality of life (HRQOL) during treatment with rilonacept vs. placebo. HRQOl was measured by the Childhood Health Questionnaire which was adopted also for adults. There are 2 summary scores: 1. Physical summary score. 2. Psychosocial summary score. The data reported below in the upper table is the physical summary composite score and in the lower table the psychosocial summary composite score. Scores were from 0-100 (higher is better) with a score of 50 representing the mean of the normal population.|12 months|Participants who received at least one treatment course of rilonacept and placebo.||Composite HRQOL summary score||Inter-Quartile Range|Median
126546|NCT00582907|Secondary|To Determine the Differences in Serum Amyloid A Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in serum amyloid A levels (mg/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo||mg/L||Inter-Quartile Range|Median
126547|NCT00582907|Secondary|To Determine the Differences in the Fibrinogen Levels Between the Treatment Arms (Rilonacept vs. Placebo)|The differences between treatment arms in the fibrinogen level (micromol/L)|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo||micromol/L||Inter-Quartile Range|Median
126548|NCT00582907|Secondary|To Determine the Differences in the Platelet Count Between the Treatment Arms (Rilonacept vs. Placebo)|The difference between the treatment arms in the platelet count X 10 to the power of 9|3 months (each treatment course, overall 12 months)|The number of patients who received at least one course each of rilonacept and placebo||cell count X10 to the power of 9||Inter-Quartile Range|Median
126549|NCT00582907|Secondary|To Determine the Differences in C-Reactive Protein Between the Treatment Arms (Rilonacept vs. Placebo)|Differences between the treatment courses in the C-Reactive Protein levels mg/L|3 months (each treatment course, overall 12 months)|Patients who received at least one course each of rilonacept and placebo||mg/L||Inter-Quartile Range|Median
126550|NCT00582907|Secondary|To Determine the Differences in the Erythrocyte Sedimentation Rate Between the Treatment Arms (Rilonacept vs. Placebo).|Erythrocyte sedimentation rate - ESR (mm/h)|3 months (each treatment course, overall 12 months)|Participants who completed at least one treatment course of both rilonacept and placebo.||mm/h||Inter-Quartile Range|Median
126551|NCT00582907|Secondary|To Determine Differences in the Time to the Development of Attacks Between the Treatment Arms (Rilonacept vs. Placebo).|In a survival analysis we measured the difference (in days) until the development of the first and second attack within a treatment course of up to 3 months and examined differences in this parameter between rilonacept and placebo. Data regarding the development of the second attack are reported below. In regards to the first attack there were no significant differences between rilonacept and placebo (20 days (7.5,>90)for rilonacept; 15 (8,32) for placebo, P=0.066).|3 months|All participants who received an intervention and developed an attack were analyzed.||days until second attack||Inter-Quartile Range|Median
126552|NCT00582907|Secondary|To Determine the Proportion of Courses in Which Subjects Attained at Least a 50% Decrease in Acute FMF Attacks During Rilonacept Courses as Compared to Placebo Courses.|Differences between rilonacept and placebo in the percentage of courses that attained at least a 50% decrease in FMF attacks when compared to attacks in the screening period.|Up to 3 months for each treatment course|Participants who completed at least one complete treatment course.||Percentage of courses|||Number
126553|NCT00582907|Secondary|Percentage of Treatment Courses Without FMF Attacks in Rilonacept Courses as Compared to Placebo Courses.|The percentage of rilonacept and placebo treatment courses without FMF attacks.|Each treatment course of up to 3 months|Participants who at least one complete treatment course.||Percentage of courses|||Number
126554|NCT00582907|Secondary|To Determine the Difference in the Length of Attacks During Treatment With Rilonacept vs. Placebo.|This outcome was the difference in days in the length of attacks between rilonacept and placebo.|12 months|Participants who received any treatment and had recorded attacks||Number of days||95% Confidence Interval|Median
126841|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126555|NCT00582907|Primary|To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo.|Differences in adverse events (AEs) between rilonacept and placebo per patient-month of treatment. We separately analyzed injection site reactions and infectious adverse events. Other adverse events were too small in number to analyze. The upper table (and first statistical analysis) regards injection site reactions and lower table (and second statistical analysis) regards infections.|12 months of entire study length|Safety analysis included all participants who received at least one dose of medication.||AEs per patient-month of treatment||Inter-Quartile Range|Median
126556|NCT00582907|Primary|To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks.|Difference in number of attacks per treatment month between rilonacept and placebo|attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)|Patients who received at least one complete treatment course and reported attacks were analyzed for the primary outcome measure.||number of attacks per month||Inter-Quartile Range|Median
126557|NCT00582894|Secondary|Number of Participants Overall Survival as a Function of Time.||100 days post transplant|Last observation carried forward||Participants|||Number
126558|NCT00582894|Primary|Number of Participants Experiencing Engraftment Donor Chimerism (EDC)||At time of study termination|||Participants|||Number
126559|NCT00582894|Secondary|Number of Participants Relapse-Free||100 days post-transplant|Last observation carried forward||Participants|||Number
126560|NCT00582894|Primary|Number of Participants Experiencing Transplant Related Mortality (TRM)||At Day 100 post trans-plant|||Participants|||Number
126561|NCT00582790|Secondary|Number of Participants With Immunologic Responses|Blood was collected to analyze T-cell populations from all patients prior to treatment on day 1 of cycles 1 and 2, and days 4 and 8 of cycles 1 and 2. Changes in gamma delta T-cell population and CD3 T-cell populations were reported.|baseline to cycle 2 day 8|One patient did not receive study treatment and so was not included in the analysis.||participants|||Number
126562|NCT00582790|Secondary|Number of Participants With Toxicities|Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events.|Baseline to 30 days after last dose of study treatment|Patients who received at least one dose of study medication. One of the 12 patients never received study medication so only 11 were evaluable for toxicity||participants|||Number
126563|NCT00582790|Secondary|Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks|All 12 patients were followed for survival until death. 8 participants who received more than one cycle of treatment and who were considered evaluable for response were followed until time to progression. Disease progression was determined by CT scans of the chest/abdomen/pelvis obtained every 2 cycles and based on RECIST version 1.0. Progression is defined using RECIST (V1.0) at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Time frame is from study entry until time to disease progression and time to death, up to 50 months|8 of the 12 participants who received more than 1 cycle of therapy and were considered evaluable for time to progression. All 12 were evaluated for survival||participants|||Number
126564|NCT00582790|Primary|Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid|Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|CT scans obtained at baseline, then every 2 cycles|Anti tumor response was measured in those patients who completed at least 1 cycle of study treatment 4 subjects did not complete 1 cycle of treatment.||participants|||Number
126565|NCT00582738|Secondary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at 12 and 24 Months Post Randomization|End of Study (EOS) endpoint is the last available assessment on or after Month 12. A reduction of at least two logs in HCV RNA viral load was considered as success|baseline, 12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. If 12-month HCV was the last available assessment, this value is used to impute the End of Study value.||log10 copies/ml||Standard Deviation|Mean
126566|NCT00582738|Secondary|Percentage of Patients in Each Study Arm With Increase of ≥1 Point in the Ishak-Knodell Staging Score in Fibrosis|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite.|baseline to month 24|Difference Ishak-Knodell Score at End-of-Study The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication||percentage of participants|||Number
126567|NCT00582738|Secondary|Comparison of the Effect of Both Regimens on the Inflammatory (Acti-test) and Fibrosis (Fibro-test) Components of Fibrosure, and on Fibrosis Area Assessed by Histomorphometry|"The Fibrosure test is the combination of Fibro-test + Acti-test.~FibroTest (FT) was for the assessment of fibrosis. Fibro test was calculated using an original combination of five highly concentrated serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin and gammaglutamyltransferase (GGT). FibroTest scores range from 0.00 to 1.00 where 0.0-0.21 is no fibrosis and >= 0.59 is cirrhosis.~Acti-test was calculated using 6 serum biochemical markers; alpha2macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and alanine aminotransferase (ALT). ActiTest (AT) was used for the assessment of necroinflammatory activity. Test score ranges from 0.00 to 1.00, where 0.00-0.17 indicates no necrosis and >= 0.61 indicates severe necrosis~If 12-month Actitest value was the last available assessment, the value is used to impute the final staging score(End of Study)"|baseline, 12 and 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||units on a scale||Full Range|Median
126568|NCT00582738|Secondary|Comparison of the Effect of Both Regimens in the Necroinflammatory Grading Score (Ishak-Knodell) (Portal Inflammation)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite|baseline, 12 months, 24 months|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||Score on a scale||Standard Deviation|Mean
126569|NCT00582738|Secondary|Comparison of Renal Function (Glomerular Filtration Rate [GFR] Calculated Using the Modification of Diet in Renal Disease Study Group [MDRD] Formula) Between Study Groups|"GFR Month 9 value if available, otherwise minimal first year post-randomization available value. Imputation rule of missing Month 24 GFR values: GFR Month 18 value if available, otherwise Month 12 GFR is used.~Least square means are from an ANCOVA model containing treatment as factor and baseline eGFR as a covariate."|12 months, 24 months/EOS|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||mL/min/1.73^2||Standard Error|Least Squares Mean
126570|NCT00582738|Secondary|Number of Patients With Events (Progression to Cirrhosis, Retransplantation, HCV Related Death, First BPAR, Graft Loss)at 12 and 24 Months||12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. During different time points, participants with observations at that time point were included in the analysis.||participants|||Number
126571|NCT00582738|Secondary|Percentage of Patients With Death, Graft Loss and Biopsy Proven Acute Rejection (BPAR) Between Study Groups||24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication.||Percentage of Participants|||Number
126572|NCT00582738|Secondary|Change From Baseline in Fibrosis Metavir Scoring at 12 and 24 Months Post Randomization|Metavir Score: F0=No fibrosis; F1=Portal fibrosis without septa; F2=Portal fibrosis with rare septa; F3=Numerous septa without cirrhosis Decrease in score from baseline indicates improvement|Baseline, 12 months, 24 months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Only participants with observations at baseline and specified timepoints were included in the analysis.||Scores on a Scale||Full Range|Median
126573|NCT00582738|Primary|Change From Baseline in Fibrosis Staging Score (Measured by the Ishak-Knodell Staging Score) Between Baseline and 24 Months Post-transplant.|"Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite~Decrease in score from baseline indicates improvement"|baseline, 24 Months|The Intent to Treat (ITT) population consisted of all patients randomized and who had at least one dose of study medication. Small number of biopsies obtained at Month 24 due to study being prematurely terminated.||Score on Scale||Full Range|Median
126574|NCT00582712|Primary|Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)||1 year|No data was ever analyzed, resulted, or published on this study.|||||
126575|NCT00582660|Primary|Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot|At 72 hours after start of treatment, the number of subjects with immunoblot demonstrated a 1.5 to 2 fold increase in 15-LOX-1 protein expression in human colorectal adenocarcinoma cell line with epithelial morphology(HT-29) and dihydrolipoamide dehydrogenase(DLD)-1 cells.|baseline to 72 hours|||Participants|||Number
126576|NCT00582660|Primary|Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib|"The Colo-Rectal adenocarcinoma will be measured by cyclooxygenase-2(COX-2) activity at 36 months post baseline.COX-2 activity (prostaglandin production).Cox-2 activity is measured by assessing tumors and normal tissue using Electron microscope and Tandem mass Spectrometry methodology though the UAB shared Mass Spectrometry facility. The methodology used was High Performance Liquid Chromatography(HPLC). additional studies include expression of genes thought to be important in colorectal carcinogenesis: COX-1 and 2, MMP, 2 7, and 9, tissue inhibitor of metalloproteinases(TIMPs) 1 ans 2 and beta-catenin."|baseline to 36 months|||Participant|||Number
126577|NCT00582556|Secondary|Number of Subjects With Decreases in Prostate Specific Antigen (PSA) After Zoledronic Acid Prior to Beginning Androgen Deprivation Therapy|"PSA response was measured by observing the serum PSA one week after beginning zoledronic acid and prior to beginning androgen deprivation therapy.~Arm 2 and Arm 3 were not able to be assessed for this endpoint as all subjects were on androgen deprivation prior to receiving zoledronic acid."|2 Years|||participants|||Number
126578|NCT00582556|Secondary|Number of Subjects Had a Significant Change in Immune Markers.|Immune markers were measured by isolating gamma-delta T cells one month after treatment with zoledronic acid.|2 Years|||participants|||Number
126579|NCT00582556|Secondary|The Number of Subjects Who Had a Significant Increase of Peripheral Blood Markers of Bone Turnover.|Serum bone-specific alkaline phosphatase was collected as the blood marker of bone turnover.|2 years|||participants|||Number
126580|NCT00582556|Primary|The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy for Prostate Adenocarcinoma.|Effects on bone mineral density were measured at four locations at six month intervals for 24 months.|2 years|||participants|||Number
126581|NCT00582517|Primary|Knee Stability|The hypothesis of this study was that there would be equivalent final knee range of motion with fewer failures for ligament reconstructions following knee dislocations that were supplemented with the Compass Knee Hinge as compared to a control group.|12 months|||participants|||Number
126842|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126582|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 3 Weeks|The number of participants who completed the study were analyzed.||Millimeters||Standard Deviation|Mean
126583|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 2 Weeks|The number of participants who completed the study were analyzed.||Millimeters||Standard Deviation|Mean
126584|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 3 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
126585|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 2 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
126586|NCT00582491|Primary|Time Spent in Sleep Stage 3 (Minutes)|Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.|After 1 Week|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
126587|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 3 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
126588|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 2 Weeks|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
126589|NCT00582491|Secondary|Overall Sleep Quality on Visual Analog Scale (Millimeters)|"Upon awakening, participants rated their overall quality of sleep. Ratings were indicated by the participants marking an X on 100 mm lines (ie worse, best). The placement of the X was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.~Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3."|After 1 Week|The number of participants who completed the study were analyzed.||Millimeters||Standard Deviation|Mean
126590|NCT00582491|Primary|Total Sleep Time (Minutes)|"Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.~Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively."|After 1 Week|The number of participants who completed the study were analyzed||Minutes||Standard Deviation|Mean
126591|NCT00582426|Secondary|Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D)|Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point.|Baseline to Day 168|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.||Units on a scale||Standard Deviation|Mean
126592|NCT00582426|Secondary|Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST)|Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as > 20 mm with conventional techniques (CT, MRI) or as > 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.|Day 56, Day 84, Day 112, Day 140, Day 168|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. N in each category indicates the number of patients analyzed with observations at that timepoint."||Percentage of Participants||95% Confidence Interval|Number
126593|NCT00582426|Secondary|Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of Participants||95% Confidence Interval|Number
126595|NCT00582426|Secondary|Percentage of Participants Who Need Opioids for Control of Diarrhea||6 months overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of Participants||95% Confidence Interval|Number
126596|NCT00582426|Secondary|Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea|For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient discontinued from the Octreotide LAR arm due to exclusion criteria after visit 1.||Percentage of participants||95% Confidence Interval|Number
126597|NCT00582426|Secondary|Percentage of Episodes by Grade|Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer.||Percentage of Episodes|Participants||Number
126598|NCT00582426|Secondary|Percentage of Patients by Grade of Diarrhea|Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.||Percentage of Participants|||Number
126599|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient by Cycle|Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)|at each cycle (28 days per cycle)|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. n indicates patients with observations during each cycle."||Episodes/patient/cycle||Standard Deviation|Mean
126600|NCT00582426|Secondary|Number of Episodes of Diarrhea by Patient|Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis.|6 months overall|ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis.||Episodes/patients/day||Standard Deviation|Mean
126601|NCT00582426|Primary|Percentage of Participants Developing Diarrhea (Grade 1 to 4)|The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.|6 month overall|"ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the Octreotide Long Acting Release Arm discontinued due to exclusion criteria after visit 1."||Percentage of Participants||95% Confidence Interval|Number
126602|NCT00582400|Secondary|Progression Free Survival|Time to progression from start of treatment|6 years|1 evaluable participant lost to follow up. No data collected.|||||
126603|NCT00582400|Secondary|Duration of Response.|Time to progression.|6 years|Participants with response||months||Full Range|Median
126604|NCT00582400|Primary|Number of Patients With Response to Treatment (RECIST Criteria)|Response included complete response, partial response or stable disease.|6 years|Participants who were evaluable for response||participants|||Number
126605|NCT00582400|Primary|Number of Participants With Treatment Related Toxicity.||6 years|||participants|||Number
126606|NCT00582361|Primary|Infections|Number of acute, delayed and deep wound infections.|Up to 12 months|||Number of infections|||Number
126607|NCT00582361|Primary|Healing of Orthopaedic Trauma Open Fractures|Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)|from surgery to wound closure|||use days||Full Range|Mean
126608|NCT00582309|Primary|Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.|The protocol were compared by measuring in each patient time to acquire the Blood Glucose (BG) target range (80-120 mg/dl) defined by reaching a BG < 120, and maintaining the target range thereafter.|24 hours|||Time to reach glycemic control in hours||Standard Deviation|Mean
126628|NCT00581945|Primary|Change From Baseline in Slow Vital Capacity (SVC)|Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population||liters||Standard Deviation|Mean
126629|NCT00581945|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population||liters||Standard Deviation|Mean
126609|NCT00582114|Other Pre-specified|Serious Adverse Events and Cardiovascular Events That Led to Trial Termination|Cardiovascular events were counted by subject and included the following: myocardial infarction (MI), stroke, hospitalization for congestive heart failure (CHF), hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. Adverse events reported are those during the course of 12 months of participation in the trial. All serious adverse events were adjudicated by R.A. and A.D.S. who were masked to the drug assignment at the time of adjudication. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. The cardiovascular event rate was calculated by treatment group assignment. Incidence rate ratio (IRR) by treatment was then determined along with the 95% confidence intervals (95% CIs). As a post hoc analysis, we also determined the narrower definition of cardiovascular events per group that included MI, stroke, CHF, or cardiovascular death.|1 yr|||events/100 patient-years|||Number
126610|NCT00582114|Primary|The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year.|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. A mixed model was used with left ventricular mass index (LVMI) as the outcome variable. Fixed effects were indicator variables for time, treatment and their interaction. Random effect was subject and statistical inference was made using the maximum likelihood estimator. No imputation was made for missing data.|Baseline, 6 months, 12 months|The primary outcome of the study was the average reduction in left ventricular mass indexed for body surface area from baseline to 1 year. The analysis was performed by intention to treat, if the patient received at least one dose of the randomized drug regardless of the availability of a post-baseline echocardiogram.||g/m^2||Standard Deviation|Mean
126611|NCT00582075|Secondary|Overall Survival||2 years|||weeks||Full Range|Median
126612|NCT00582075|Primary|Percentage of Participants With Distant Brain Failure (DBF) at One Year|Patients developing distant brain failure (DBF) at one year.|1 years|||percentage of participants|||Number
126613|NCT00582036|Primary|Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT)||100 days|Due to early termination, data not analyzed||Participants|||Number
126614|NCT00582036|Secondary|Reduced Length of In-hospital Stay||About 100 days||||||
126615|NCT00582036|Secondary|Reduction of Infection||About 100 days||||||
126616|NCT00582010|Primary|Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery|Number of any complication reported by subjects at 9 months after surgery|baseline to 9 months post surgery|||complications|||Number
126617|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)|Number of complications due to hepatobiliary events.|baseline to 9 months after transplantation|||Complications|||Number
126618|NCT00582010|Secondary|Effect of iNO on SICU Stay|Number of minutes after surgery subject remained in SICU|baseline to discharge for SICU|||minutes||Inter-Quartile Range|Mean
126619|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)|A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline|||percent change from baseline||Standard Deviation|Mean
126620|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))|The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase.|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
126621|NCT00582010|Primary|Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)|The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease.|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
126622|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)|The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline).|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
126623|NCT00582010|Secondary|Effect of iNO on Hosptial Length of Stay|number of days subject in hospital after surgery until discharge|from surgery through discharge from hospital|||days||Inter-Quartile Range|Mean
126624|NCT00582010|Primary|Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)|The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline).|baseline and 96 hours after baseline|||percentage change from baseline||Standard Deviation|Mean
126625|NCT00581971|Primary|Response as Evaluated by Recurrence of Diseases|Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.|2 years from end of treatment (Radiation therapy)|||Participants|||Number
126626|NCT00581971|Primary|Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.|Particpants experiencing Acute Toxicities > Grade 3|2 years from radiation therapy|||participants|||Number
126627|NCT00581945|Primary|Change From Baseline in Forced Expiratory Flow 25% to 75%|The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.|Baseline, Week 25 and Week 45|Safety population||L/sec||Standard Deviation|Mean
126677|NCT00581308|Secondary|Secondary Outcome: Total Time Under Fluoroscopy||Procedure|||minutes||Full Range|Median
126678|NCT00581308|Secondary|Total Time Under Fluoroscopy||Procedure|||minutes||Standard Deviation|Mean
126630|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted|"The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function."|Baseline, Week 25 and Week 45|Safety population||Percent of predicted||Standard Deviation|Mean
126631|NCT00581945|Secondary|Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events|Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.|Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.|The safety population consisted of all randomized patients who received at least one dose of the study drug.||Participants|||Number
126632|NCT00581945|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|Baseline, Week 25 and Week 45|The safety population consisted of all randomized patients who received at least one dose of the study drug.||Liters||Standard Deviation|Mean
126633|NCT00581919|Secondary|Progression-free Survival|Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.|||months||Full Range|Median
126634|NCT00581919|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed up to 7 years|||months||Full Range|Median
126635|NCT00581919|Primary|Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR|"Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.~Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.~Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis."|Every 21 days, up to 24 weeks|||percentage of participants||90% Confidence Interval|Number
126636|NCT00581867|Secondary|Global Cognition|Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.|90 mins|||z-scores||Standard Deviation|Mean
126637|NCT00581867|Primary|fMRI Measure of Hippocampal Activation|Percentage active voxels of total hippocampal volume of interest|30 minutes After Intervention Administration|||percentage of active voxels||Standard Deviation|Mean
126638|NCT00581854|Primary|Complete Response Rate to Induction Therapy|Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999).|Median follow up of 37 months|All Subjects enrolled were included in the analysis. Response rate is represented as % of total subjects enrolled.||percentage of participants||90% Confidence Interval|Number
126639|NCT00581828|Primary|Change in Intestinal Calcium Absorption From Baseline to One Month|percent and true fractional calcium absorption|1 month|One subject's urine sample was mishandled, leaving 18 subjects with complete data for analysis.||percent calcium absorption||Standard Deviation|Mean
126640|NCT00581776|Secondary|3 Year Overall Survival (OS)|This is the percent of participants who were still alive at 3 years after study entry.|36 months|||Percent of participants||95% Confidence Interval|Number
126641|NCT00581776|Secondary|3 Year Progression Free Survival|This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.|36 months|||percent of participants||95% Confidence Interval|Number
126642|NCT00581776|Primary|Complete Response Rate (CR) at the End of Induction Chemotherapy|Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.|at 21 weeks|||percent of participants||95% Confidence Interval|Number
126643|NCT00581776|Primary|Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).|"Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy.~1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses."|At completion of induction therapy (21 weeks)|||Percent of participants||95% Confidence Interval|Number
126679|NCT00581308|Secondary|Secondary Analyses Will be Performed on All Patients Enrolled With a Device Implanted, Regardless of Meeting Inclusion / Exclusion Criteria or Anatomic Suitability Criteria, Using Data From All Visit Evaluations.||1 year postprocedure||||||
126644|NCT00581581|Primary|WeeFIM Score|WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from “1” for total assistance, total dependence, maximal prompting, or not testable to “7” for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.|7-8 years after initial intervention|||percentage of participants|||Number
126645|NCT00581555|Secondary|Percentage of Rebound Effects|Rebound effects was defined as worsening of psoriasis to 125% of the baseline PASI or appearance of psoriasis variants such as erythrodermic or pustular psoriasis within 12 weeks of discontinuation of therapy.|Baseline to Week 24.|ITT population: included all randomized participants.n equals number of participants with evaluable data for this outcome measure.||percentage of participants|||Number
126646|NCT00581555|Secondary|DLQI at Each Visit From Baseline|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10 item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Baseline to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data||scores on a scale||Standard Error|Mean
126647|NCT00581555|Secondary|Change From Randomization in DLQI to Week 24|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||scores on a scale||95% Confidence Interval|Mean
126648|NCT00581555|Secondary|Percent (%) Change of PASI Score From Randomization to Week 24|Percent improvement in PASI score was calculated from Week 6 to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||percent change||95% Confidence Interval|Mean
126649|NCT00581555|Primary|Change From Randomization in PASI Score to Week 24 (Week 18 of Etanercept Monotherapy/Placebo)|PASI score: range: 0 (none) to 72 (maximum). Body was divided into head, upper extremities, trunk and lower extremities; each area score was combined for final PASI. For each section, percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: (erythema, induration, and desquamation); scale: 0 (none) to 4 (maximum). Final PASI= sum of severity parameters for each section times area score times weight of section (head: 0.1, upper extremities: 0.2, trunk: 0.3, lower extremities: 0.4). Change = PASI at Week 24 - PASI at baseline.|Randomization to Week 24.|Intent-To-Treat (ITT) population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||scores on a scale||95% Confidence Interval|Mean
126650|NCT00581555|Secondary|Probability of Being Relapse Free During the 24 Weeks After Randomization|Relapse was defined as loss of 50% improvement in PASI. The time to relapse was estimated using a Kaplan-Meier analysis.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||probability of relapse free|||Number
126651|NCT00581555|Secondary|Relapse (Loss of 50% Improvement in PASI) During the 24 Weeks After Randomization|Relapse was defined as the loss of 50% improvement in PASI.|Randomization to Week 24.|ITT population: that included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||Percentage of participants|||Number
126652|NCT00581555|Secondary|Change From Randomization in PGA Score to Week 24|PGA score is based on dermatologist's assessment of disease averaged over all lesions. Overall lesions were graded for individual scores of induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Change = PGA at Week 24 - PGA at baseline.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data for this outcome measure.||scores on a scale||95% Confidence Interval|Mean
126653|NCT00581555|Secondary|PASI Area Under the Curve (AUC) Between Randomization and Week 24|PASI AUC = Area under the curve from randomization (Week 6) to Week 24.|Randomization to Week 24.|ITT population: included all randomized participants. n equals number of participants with evaluable data.||scores on a scale * weeks||Standard Error|Mean
126654|NCT00581542|Secondary|Number of Participants With a Negative Bacterial Culture|Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.|10 days|Only participants who were culture positive at baseline were tested at day 10. 20 participants were negative at baseline in the polytrim group and 11 participants were negative in the moxifloxin group.||participants|||Number
126655|NCT00581542|Primary|Number of Participants With Normal Physical Examination of the Eye||10 days|||participants|||Number
126656|NCT00581529|Secondary|Ratio of Percentage of Prescription Dose Received to WBV|One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the ratio of percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes and participants who maintained excellent/good (E/G) cosmetic outcomes. Multiple percentages of prescription dose were examined: 5%, 20%, 50%, 80% and 100%.|5 years||||||
126657|NCT00581529|Secondary|Dosimetric and Volumetric Differences Between Treatment Plans for Partial Breast Irradiation and Other Treatment Planning Methods|Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.|not specific||||||
126680|NCT00581308|Primary|Clinical Success Endpoint||12 months|Subjects with Successful Device Delivery||Participants|||Number
126658|NCT00581529|Primary|Percentage of Participants That Experience Cosmetic Adverse Events (AEs)|The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.|5 years|34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis. 2 additional patients underwent mastectomies and were therefore excluded from analysis (cosmesis could not be assessed at 5 years). 30 patients were analyzed.||percentage of participants|||Number
126659|NCT00581529|Primary|Rate of Local Control at 5 Years|The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.|5 years|34 for patients were enrolled and treated.||percentage of participants|||Number
126660|NCT00581399|Secondary|Duration of Mediastinal Drainage|The outcome to measure is the duration of the chest tubes inserted in the patient in hours. The time starts at the time the chest is completely closed and the end time when the chest tubes are pulled out of the patient's chest.|Immediate postoperative when the chest is completely closed to the time chest tubes are pulled out of the patient|||Hours||Standard Deviation|Mean
126661|NCT00581399|Primary|Amount of Postoperative Bleeding|The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.|24-48 hours post surgery|||mL||Standard Deviation|Mean
126662|NCT00581386|Primary|Number of Failed Cases|We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.|Time taken for successful intubation|As per protocol, a case is decided as a failed case when the patient was not able to be intubated with the assigned device after 3 attempts.||Participants|||Number
126663|NCT00581386|Primary|Post Operative Morbidity|We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.|2 hrs and 24 hrs after surgery|As per protocol,all the patients were followed up at 2 hrs and 24hrs to check for any postoperative hoarseness, sorethroat and difficulty swallowing. The numbers represent the number of patients who complained of postoperative morbidity.||participants|||Number
126664|NCT00581386|Primary|Leak Pressures|The maximum leak pressure attained for each device.|Duration of surgery|||cm of H2O||Standard Deviation|Mean
126665|NCT00581386|Primary|Number of Patients Who Required Multiple Attempts.|The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.|Time taken for intubation|As per protocol,the number of cases in whom the device could not be placed successfully in first attempt and required 2nd and 3rd attempts.||Participants|||Number
126666|NCT00581386|Primary|Number of Participants With a Successful First Attempt Placement|The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.|Time taken for successful placement|As per protocol,of all the patients intubated with the assigned specific device number of patients in whom the device was placed successfully in the first attempt.||Participants|||Number
126667|NCT00581386|Primary|Duration of Intubation|The time taken to successfully place the device in seconds.|duration of intubation|||seconds||Standard Deviation|Mean
126668|NCT00581360|Secondary|Median Duration of Stable Disease Response|Median number of months of Stable Disease Response Per RECIST v1.0 (Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 36 months|||months||Full Range|Median
126669|NCT00581360|Secondary|Number of Months of Survival|Number of months that the participant was alive.|Up to 5 years|||months|||Number
126670|NCT00581360|Secondary|Number of Months of Progression-free Survival (PFS)|Number of months that participants experienced stable disease (the disease does not progress per RECIST v1.0 criteria - Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started)|Up to 5 years|||months|||Number
126671|NCT00581360|Primary|Stable Disease Rate|Using RECIST v1.0 criteria, stable disease rate is the number participants experiencing stable disease (SD) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD).|Up to 5 years|All patients in this population had stable disease as best response.||percentage of participants|||Number
126672|NCT00581360|Primary|Objective Response Rate (ORR)|ORR is the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) / the number participants experiencing partial response (PR) + the number participants experiencing complete response (CR) + the number participants experiencing stable disease (SD) + the number participants experiencing progressive disease (PD). RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest s|Up to 5 years|||percentage of participants|||Number
126673|NCT00581347|Secondary|Receipt of a Well Child Visit Within a 12 Month Period|We compared the number of participants in the intervention group who received a well child visit within a 12 month period versus those in the control group.|1 year|||participants|||Number
126674|NCT00581347|Primary|Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)|We compared the number of participants in the intervention group who received vaccinations for Tdap, Menactra, and (for girls only) HPV at the end of the study period versus those in the control group.|15 months|||participants|||Number
126675|NCT00581308|Secondary|Secondary Outcome: Days in Hospital for Procedure||Post Procedure|||Days||Full Range|Median
126676|NCT00581308|Secondary|Days in Hospital for Procedure||Post Procedure|||Days||Standard Deviation|Mean
126681|NCT00581256|Secondary|The Number of Participants That Experience Pericarditis and Pneumonitis|"To compare rates of pericarditis and pneumonitis by treatment arm.~Pericarditis (inflammation of the pericardium):~Grade1: Asymptomatic, ECG or physical exam; changes consistent with pericarditis Grade 2: Symptomatic pericarditis Grade 3: Pericarditis with physiologic consequences Grade 4: Life-threatening Pneumonitis (inflammation of the walls of the alveoli in the lungs) Grade 1: Asymptomatic, radiographic findings only Grade 2: Symptomatic, not interfering with ADL (activities of daily living) Grade 3: Symptomatic, interfering with ADL Grade 4: Life-threatening"|approx 1 year|||participants|||Number
126682|NCT00581256|Secondary|Number of Participants With New Lung Perfusion Defects|To compare changes in lung perfusion defects by treatment arm. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution’s normal polar map databases for the left anterior descending artery (LAD).|baseline to approx 1 year|One patient randomized to the IMRT arm did not receive her post-RT lung SPECT scan therefore pre- and post-radiotherapy Lung SPECT scans were available for 53 patients.||participants|||Number
126683|NCT00581256|Secondary|Mean Percent Change in Ejection Fraction (LVEF)|To compare change in ejection fraction between treatment arms.|baseline to approx 1 year|||percent change||Full Range|Mean
126684|NCT00581256|Primary|The Number of Participants With a Significant Increase in Perfusion Defects (PD)|To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution’s normal polar map databases for the left anterior descending artery (LAD) using thresholds of 2.5-SD (standard deviation) and 1.5-SD below the normal mean. On the basis of interest variability, a PD increase greater than 5% or 10% was considered significant for 2.5- and 1.5-SD thresholds, respectively.|1 Year|||participants|||Number
126685|NCT00581230|Primary|Glottic View as Assessed by the Cormack and Lehane Classification|Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible|before intubation|||participants|||Number
126686|NCT00581230|Primary|Ease of Mask Ventilation as Assessed by Han Class|Grading Scale for Mask Ventilation as described by Han et al. (Anesthesiology. 2004 Jul;101(1):267) Grade 0. Ventilation by mask not attempted Grade 1. Ventilated by mask Grade 2. Ventilated by mask with oral airway/adjuvant with or without muscle relaxant Grade 3. Difficult ventilation (inadequate, unstable, or requiring two providers) with or without muscle relaxant Grade 4. Unable to mask ventilate with or without muscle relaxant|Time before intubation|||participants|||Number
126687|NCT00581113|Primary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Brain metastases bi-dimensional area|12 months post RT|Not enough patients were enrolled to allow for any meaningful analysis.|||||
126688|NCT00581113|Secondary|Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI.|Increase in the bi-dimensional tumor area for any of the tracked brain metastases or the appearance of any new brain metastases on a follow-up MRI.|12 months after end of radiation therapy|Study terminated early due to poor accrual|||||
126689|NCT00581100|Secondary|Change From Baseline in Physician Fingernail Grading Assessment Total Score|Physician assessment of disease activity for each fingernail; range: 0 (no disease), 1 (mild disease, 2 (moderate disease), or 3 (severe disease). Total score range = 0-30.|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
126690|NCT00581100|Secondary|Change From Baseline in Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Patient global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
126691|NCT00581100|Secondary|Change From Baseline in Physician Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Physician global assessment of disease activity using a visual analog scale; range: 0 (no nail disease) to 100 (worst possible nail disease).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
126692|NCT00581100|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI)|Self-administered questionnaire to measure health-related quality of life (QoL)of adult patients suffering from skin disease; 10 questions concerning patients' perception of impact of their disease over last week encompassing aspects such as symptoms, feelings, daily activities, leisure, work, school, personal relationships and side effects of treatment. Questions scored on a 4-point Likert scale: 0 (not at all/not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of patient's QoL.|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
126693|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Mild or Better|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of mild or better = PGA score of ≤ 2 (mild plaque elevation, mild scaling, and light red coloration).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.||percent of participants|||Number
126694|NCT00581100|Secondary|Percent of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear or Almost Clear|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Week 24 or Early Termination|mITT, N = number of participants with evaluable data.||percent of participants|||Number
126695|NCT00581100|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Psoriasis|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Baseline, Week 24|mITT, N = number of participants with evaluable data.||unts on a scale||95% Confidence Interval|Mean
126696|NCT00581100|Secondary|Percent of Participants Achieving a 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
126697|NCT00581100|Secondary|Percent of Participants Achieving a 50% Improvement in the Psoriasis Area and Severity Index (PASI) Score at Week 12 and Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12 , Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
126698|NCT00581100|Secondary|Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area was scored by itself and scores were combined for final PASI. For each section percent (%) area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
126699|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.||units on a scale|||Number
126700|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Week 12, Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
126701|NCT00581100|Secondary|Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
126702|NCT00581100|Secondary|Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores 0-8: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail),4 (present in 4/4 nail). Higher score = more severe psoriasis.|Week 12, Week 24|mITT, N = number of participants with evaluable data.||percent of participants|||Number
126703|NCT00581100|Secondary|Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score|NAPSI (matrix + bed score) performed on dorsal views of 8 fingers, excluding thumb; range: 0 to 8. Overall NAPSI score = sum of all fingernail scores; range: 0 to 64. Nails were divided into quadrants and graded for nail matrix and bed psoriasis. Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present 1/4 nail), 2 (present 2/4 nail), 3 (present 3/4 nail), and 4 (present 4/4 nail).|Baseline, Week 24|mITT, N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
126843|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126704|NCT00581100|Primary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail|Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.|Baseline, Week 24|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least one dose of study medication, and provided baseline and post-baseline data. N = number of participants with evaluable data.||units on a scale||95% Confidence Interval|Mean
126705|NCT00581061|Secondary|Side Effects|Number of people who experienced side effects while taking Vesicare, per study protocol.|3 months|||participants|||Number
126706|NCT00581061|Secondary|Compliance|Number of subjects that were in compliance with the study protocol and took medication for at least one month.|3 months|per protocol||participants|||Number
126707|NCT00581061|Primary|Time to Continence|Time in days to achieve pad free urinary continence|12 months|||days||Standard Deviation|Mean
126708|NCT00580983|Secondary|The Mean Esophageal Radiotherapy Dose in Patients With Strictures and Without Strictures|To assess the relationships between the mean radiotherapy dose delivered and objectively measured dysphagia.|5 years|||Gray (Gy)||Standard Deviation|Mean
126709|NCT00580983|Primary|Percentage of Participants With Grade 0-1 Observer-rated Dysphagia|To objectively assess dysphagia and aspiration in patients receiving dysphagia/aspiration-sparing IMRT concurrent with chemotherapy, the percentage of participants with observer-rated dysphagia was calculated.|12 months|90 patients were enrolled. Only 80 patients were treated and 7 patients did not complete the 12 month post-Radiation Therapy (RT) swallowing studies. Therefore only 73 patients were analyzed.||percentage of participants|||Number
126710|NCT00580970|Primary|Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment|The primary endpoint of this study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. A one sided test will be conducted in order to evaluate reduction of risk from adding Lovastatin. The analysis is using a one-stage design, 5% level of significance, and 83% power.|24 months|The primary endpoint of the study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment. Only the highest-grade toxicity for each symptom was counted. Symptoms starting in the acute period and unresolved beyond 90 days post treatment are considered late toxicity.||percentage of participants|||Number
126711|NCT00580957|Primary|Insulin Resistance|Glucose infusion rate in mg/kg/min|Last 30 minutes of a two hour insulin clamp|||mg/kg/min||Standard Error|Mean
126712|NCT00580866|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Score|Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )|12 months post-operatively|||scores on a scale||95% Confidence Interval|Mean
126713|NCT00580866|Primary|Elbow ROM at 12 Months|The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.|2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively|Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.||degrees||95% Confidence Interval|Mean
126714|NCT00580840|Other Pre-specified|Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Swollen Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Joints||Standard Error|Least Squares Mean
126715|NCT00580840|Other Pre-specified|Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Tender Joint Count is computed as the value at Week 34 minus the Baseline value (28 joints were assessed at each visit). A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Joints||Standard Error|Least Squares Mean
126716|NCT00580840|Other Pre-specified|Change From Baseline in PhGADA (Physician’s Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Physician’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126717|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the ESR value at Week 34 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (69 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||95% Confidence Interval|Least Squares Mean
126844|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126718|NCT00580840|Other Pre-specified|Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients|Ratio is defined as the ESR value at Week 16 divided by the ESR value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||Geometric Coefficient of Variation|Geometric Mean
126719|NCT00580840|Secondary|Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.|ACR20 loss are subjects with <20% improvement from Baseline for tender joint count, swollen joint count, and at least 3/5 core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein, 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale at 2 consecutive visits. Subjects losing response for 2 consecutive visits are considered as having the event on the day of the visit where response was first lost.|Week 18 up to Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis.||days||Inter-Quartile Range|Median
126720|NCT00580840|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126721|NCT00580840|Secondary|Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 34 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126722|NCT00580840|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126723|NCT00580840|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 202 subjects (66 400 mg CZP, 68 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126724|NCT00580840|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126725|NCT00580840|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (67 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126726|NCT00580840|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126727|NCT00580840|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126728|NCT00580840|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126729|NCT00580840|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126730|NCT00580840|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 69 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126731|NCT00580840|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126732|NCT00580840|Secondary|Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Week 34 minus the Baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126733|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 34 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126734|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18|Ratio is defined as the CRP value at Week 34 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method with an ANCOVA model on observed log transformed data with factors treatment and log transformed Baseline CRP level. The number presented is the geometric least squares mean with it's 95% confidence interval.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 207 subjects (69 400 mg CZP, 70 200 mg CZP, 68 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||95% Confidence Interval|Least Squares Mean
126752|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
126735|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
126736|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
126737|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
126738|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score. Range for CDAI is 0-76 with a lower CDAI score reflects approvement in activity and a higher score reflects a decline.|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 206 subjects (69 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126739|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward (LOCF) data with factors treatment and Baseline score.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 205 subjects (68 400 mg CZP, 70 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126740|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using an ANCOVA model on Last Observation Carried Forward.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 204 subjects (69 400 mg CZP, 68 200 mg CZP, 67 placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Error|Least Squares Mean
126741|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
126742|NCT00580840|Secondary|Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
126866|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"||Week 12|FAS||Participants|||Number
126743|NCT00580840|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
126744|NCT00580840|Secondary|Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients|Ratio is defined as the CRP value at Week 16 divided by the CRP value at Baseline. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 16|Of the 333 subjects in the Run-in period, 330 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||Ratio||Geometric Coefficient of Variation|Geometric Mean
126745|NCT00580840|Secondary|CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating approvement in activity and a higher score indicating a decline activity."|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
126746|NCT00580840|Secondary|SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
126747|NCT00580840|Secondary|DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
126748|NCT00580840|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline, Week 16|Of the 333 subjects in the Run-in period, 328 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
126749|NCT00580840|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 326 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
126750|NCT00580840|Secondary|Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients|"DAS28-ESR is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High"|Baseline, Week 16|Of the 333 subjects in the Run-in period, 325 are included in this analysis using the Last Observation Carried Forward (LOCF) method.||units on a scale||Standard Deviation|Mean
126751|NCT00580840|Secondary|Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
126764|NCT00580801|Secondary|Median Time to First Viral Response (Undetectable HCV RNA)|Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.|Up to Week 48/50|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.||Days||95% Confidence Interval|Median
126753|NCT00580840|Secondary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 16|Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis||percentage of subjects|||Number
126754|NCT00580840|Primary|Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)|Baseline, Week 34|Of the 208 subjects in the Full Analysis Set (FAS) 208 subjects (69 400 mg CZP, 70 200 mg CZP, 69 placebo) are included in this analysis which uses Non-Response Imputation (NRI).||percentage of subjects|||Number
126755|NCT00580801|Secondary|Average Steady-State Serum Concentration (Css,av) of Telaprevir|The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
126756|NCT00580801|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir|The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."||Hours||Full Range|Median
126757|NCT00580801|Secondary|Minimum Serum Concentration (Cmin) of Telaprevir on Day 15|The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
126758|NCT00580801|Secondary|Pre-Dose Serum Concentration (C[0h]) of Telaprevir|The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|0 hour (pre-dose) at Day 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
126759|NCT00580801|Secondary|Maximum Serum Concentration (Cmax) of Telaprevir|The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated–interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated–interferon-alfa-2a+Ribavirin (test).|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."||Nanogram/milliliter (ng/mL)||Standard Deviation|Mean
126760|NCT00580801|Secondary|Area Under the Serum Concentration-Time Curve (AUC)|The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15|"Intent-to-treat (ITT) population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively."||nanogram*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
126761|NCT00580801|Secondary|Percentage of Participants With Relapse|Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.|Week 24 after EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. N signifies those participants who were evaluated for this measure."||Percentage of participants|||Number
126762|NCT00580801|Secondary|Percentage of Participants With Sustained Viral Response (SVR)|Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.|Week 12 and 24 after the last dose of study medication|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.||Percentage of participants|||Number
126763|NCT00580801|Secondary|Number of Participants With Viral Breakthrough (Detectable HCV RNA)|Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable [less than 25 IU/mL]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 8, Day 12, Day 15, Week 24/26 and Week 36/38|Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.||Participants|||Number
126787|NCT00580671|Primary|Marijuana Abstinence (4 Weeks or Greater)|Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Twice weekly urine tests for 14 weeks.|||percentage of participants|||Number
126765|NCT00580801|Secondary|Percentage of Participants With Viral Response (Undetectable HCV RNA)|Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants’ plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.|Day 15 up to EOT (Week 48/50 or early discontinuation)|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||Percentage of participants|||Number
126766|NCT00580801|Primary|Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15|The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification [LLOQ=25 IU/mL] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline and Day 15|"Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||log 10 IU/mL||Full Range|Median
126767|NCT00580788|Secondary|Fractional Excretion of Calcium|% calculated from daily second morning void|daily|||% of filtered load||Standard Error|Mean
126768|NCT00580788|Secondary|Parathyroid Hormone (1-84)|pg/ml|Baseline and Daily|||pg/ml||Standard Error|Mean
126769|NCT00580788|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
126770|NCT00580788|Secondary|Amino-terminal Peptides of Procollagen 1 (P1NP)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
126771|NCT00580788|Secondary|Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
126772|NCT00580788|Secondary|Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)|% change from baseline|Baseline, Daily, and 1 week follow-up|||% change||Standard Error|Mean
126773|NCT00580788|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
126774|NCT00580788|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
126775|NCT00580788|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
126776|NCT00580788|Secondary|Tubular Maximum of Phosphorous (TmP/GFR)|mg/dl calculated from daily second morning void|daily|||mg/dl||Standard Error|Mean
126777|NCT00580788|Secondary|24 Hour Urine Calcium|mg/gm creatinine collected on day 7 of PTHrP infusion|24 hours|||mg/gm creatinine||Standard Error|Mean
126778|NCT00580788|Secondary|1,25 Vitamin D|pg/ml|Baseline and Daily through day 8 then at follow-up visit|||pg/ml||Standard Error|Mean
126779|NCT00580788|Primary|Dose Limiting Toxicity (DLT)|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days|||participants|||Number
126780|NCT00580723|Primary|Telangiectasia Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean telangiectasia severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.||Telangiectasia percent improvement||Standard Deviation|Mean
126781|NCT00580723|Primary|Inflammatory Lesion Count|Lesion counts were numerically summed for each patient at each encounter, and the average lesion count was calculated from all continuing 16 subjects at each visit, for a total of 8 visits. Percent improvement (reduction in lesion number) was assessed by comparing the average number of lesions at week 48 to the average number of lesions assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.||Percent change in number of lesions||Standard Deviation|Mean
126782|NCT00580723|Secondary|Cosmetic Acceptability||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48||||||
126783|NCT00580723|Secondary|Transepidermal Water Loss (TEWL)||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48||||||
126784|NCT00580723|Secondary|Skin Photodamage||Baseline, Weeks 1, 4, 8, 12, 24, 36, 48||||||
126785|NCT00580723|Secondary|Skin Tolerance||Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48||||||
126786|NCT00580723|Primary|Erythema Severity|Measured by percent improvement on a scale of 0-4. Subjects received a 0 for no improvement, 1 for less than twenty-five percent improvement, a 2 for twenty-five to fifty percent improvement, a 3 for fifty to seventy-five percent improvement and a 4 for greater than seventy-five percent improvement. Mean scores from all continuing 16 participants were averaged for each encounter, for a total of 8 visits. The percent improvement in mean erythema severity was calculated by comparing the change in mean scores at week 48 to mean scores assessed at baseline.|Baseline, Weeks 1, 4, 8, 12, 24, 36, 48|We had a total of 24 subjects. Five were lost to follow up and three did not want to participate in the extension period. The results from the remaining 16 subjects were analyzed.||Erythema percent improvement||Standard Deviation|Mean
126788|NCT00580671|Secondary|Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)|This reflects the mean proportion of days of marijuana abstinence for each participant|This is for the proportion of days abstinent across the entire 14-week treatment period. Self-report data are collected twice weekly during treatment to obtain a cumulative proportion|Those participants with data on at least 80 days of the 91 days of treatment were used in this analysis.||proportion of marijuana abstinent days||Standard Deviation|Mean
126789|NCT00580671|Primary|Marijuana Abstinence (2 Weeks or Greater)|Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.|Testing done twice weekly for 14 weeks.|||percentage of participants|||Number
126790|NCT00580606|Secondary|Percent of Participants Who Successfully Consumed 10,000 mg of Peanut Powder|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of peanut powder during a double-blind placebo-controlled oral food challenge were then given an open feeding of peanut butter and those who successfully consumed the open feeding were counted as successes.|Approximately 8 weeks after discontinuing study therapy after 3 years on maintenance study therapy|All subjects randomized to the Low Dose Peanut SLIT group and all subjects randomized to the Placebo group who crossed over to open label high dose peanut sublingual immunotherapy were included.||percentage of participants|||Number
126791|NCT00580606|Secondary|Number of Crossover Participants With Serious Adverse Events (SAEs) During 44 Weeks of Open Label Peanut Protein Consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.|Initiation of open label peanut protein study therapy through Week 44 of open label peanut protein consumption|All subjects who were in the Placebo group during the double-blind phase of the study who initiated crossover peanut sublingual immunotherapy during the open label phase of the study will be included.||participants|||Number
126792|NCT00580606|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||participants|||Number
126793|NCT00580606|Secondary|Percent of Crossover Participants Who Achieved an Open Label Peanut Protein Consumption Maintenance Dose of 3,696 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 3,696 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 after initiating crossover open label peanut protein consumption|All subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included.||Percentage of participants|||Number
126794|NCT00580606|Secondary|Percent of Crossover Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge After 44 Weeks of Open Label Peanut Protein Consumption|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 after initiating crossover open label peanut protein consumption|Subjects in the Placebo group during the double-blind period who crossed over to open label high dose peanut sublingual immunotherapy were included except for 1 subject who refused the crossover Week 44 OFC and could not be evaluated. 4 subjects who discontinued dosing prior to the crossover Week 44 OFC were counted as failures.||Percentage of participants|||Number
126795|NCT00580606|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 1,386 mcg|During the build-up phase, escalation was to occur every 2 weeks until the 1,386 mcg maintenance dose was reached. The maximum time allowed for the build-up phase was 36 weeks; the dose achieved by 36 weeks was considered the maintenance dose.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||Percentage of participants|||Number
126796|NCT00580606|Primary|Percent of Participants Who Successfully Consumed 5,000 mg of Peanut Powder or at Least a 10-fold Increase in the Amount of Peanut Powder Compared to Their Baseline Oral Food Challenge|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.|Week 44 (Double Blind Period)|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||Percentage of participants|||Number
126797|NCT00580502|Secondary|Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of HbA1c from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population.||percentage of HbA1c||Standard Deviation|Mean
126798|NCT00580502|Secondary|Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of Triglycerides from baseline at 5 years|5 years|All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population.||mg/dl||Standard Deviation|Mean
126799|NCT00580502|Secondary|Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery|Change in level of LDL from baseline at 5 years|5 years|All participants who underwent LAGB are included in the analysis population.||mg/dl||Standard Deviation|Mean
126800|NCT00580502|Primary|To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery|Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.|5 years|All participants who underwent LAGB are included in the analysis population.||percentage of excess weight loss||Standard Deviation|Mean
126801|NCT00580398|Secondary|Biochemically-validated 7-day Point Prevalence Tobacco Abstinence|7-day point prevalence abstinence (“Have you smoked a cigarette, even a puff, in the past 7 days?”) was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm.|12 weeks|46 participants (32 intervention, 14 control) returned a cotinine confirmation kit for biochemical validation of 7 day point prevalent tobacco abstinence at 12 weeks. 3 control participants were excluded from the follow-up analysis.||participants|||Number
126803|NCT00580372|Primary|Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy|"Relapse is defined by the unequivocal objective evidence of recurrent disease such as:~myeloma-related cytogenetic abnormalities; bone marrow plasmacytosis >10% or >5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for >2 months."|5 years|||percentage of participants|||Number
126804|NCT00580294|Primary|Brief Pain Inventory||Assessed daily for 10 days prior to IV PCA treatment, and assessed daily for 2 weeks after IV PCA treatment||||||
126805|NCT00580294|Primary|Change in Patient Global Impression of Change|PGIC score - participants answered 2 questions regarding change in overall status and overall activity from baseline using a 7-point scale (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse)|baseline and 12 hours|||units on a scale||95% Confidence Interval|Mean
126806|NCT00580229|Secondary|DAS-28||weeks 4, 8, 16, 26||||||
126807|NCT00580229|Secondary|HAQ-DI||weeks 4, 8, 16, 26||||||
126808|NCT00580229|Secondary|All AE’s Through Week 26.||26 weeks||||||
126809|NCT00580229|Secondary|All AE’s Within 24 Hours Following the Second Infusion.||24 hours||||||
126810|NCT00580229|Secondary|All Acute Infusion Reactions With 24 Hours Following the Second Infusion.||24 hours||||||
126811|NCT00580229|Secondary|All Adverse Events (AE’s) Within 24 Hours Following the First Infusion.||24 hours||||||
126812|NCT00580229|Primary|The Safety and Tolerability of Rituximab in RA by Assessing Number of Participants With Acute Infusion Reactions in the First 24 Hours.|The safety and tolerability of rituximab in RA by assessing number of participants with acute infusion reactions in the first 24 hours.|24 hours|The subjects full filled the American College of Rheumatology Criteria for Rheumatoid Arthritis.||participants|||Number
126813|NCT00580151|Secondary|Anxiety Reduction|"The Fear Thermometer measures how much fear subject is currently having. (0=None, 1= A little bit, 2= Some, 3= A lot, 4= Very, very much). The average of daily Value for 10 days."|Average of the 10 days|Patients analyzed were all patients consented.||units on a scale||Full Range|Mean
126814|NCT00580151|Primary|Pain Reduction|"The scale name is FACES (Faces Pain Rating Scale). Subjects were asked rate your WORST PAIN today (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged."|Average of the 10 days|Determined by the number of patients recruited.||units on a scale||Full Range|Mean
126815|NCT00580138|Primary|Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing.|Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.|2 years|||percent agreement|||Number
126816|NCT00580034|Secondary|Response|Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR). CR for malignant hematologic diseases is met if all the following are met for >/= 1 month: a) absence of pathologic lymphadenopathy by physical and radiographic exam b) absence of constitutional symptoms due to disease c) Polymorphonuclear leukocyte count >1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL d) bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc. e) molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc. CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values.|2 years|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.||months||Full Range|Mean
126817|NCT00580034|Primary|Overall Survival (OS)|Estimate toxicity and overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death.||months||Full Range|Mean
126818|NCT00580034|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects on the study who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.||participants|||Number
126819|NCT00579982|Secondary|Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation|Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)|End of Study (Week 3) or at Early Withdrawal|ITT: Only 94 of the 97 subjects in the ITT Population responded to the Tablet Routine Questionnaire.||Number of participants|||Number
126820|NCT00579982|Secondary|Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3|Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
126821|NCT00579982|Secondary|Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3|Participant indicated whether preference was for ODT or the standard IR tablet|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
126822|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? [from a rating of 1 (Extremely difficult) to 5 (Extremely easy)]|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
126823|NCT00579982|Secondary|"Number of Participants Answering the Question Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet? at Week 3"|Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 [Extremely inconvenient] to 5 [Extremely convenient])|End of Study (Week 3) or at Early Withdrawal|ITT||Number of participants|||Number
126824|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Aftertaste of the Tablet? at Week 3"|Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
126825|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Aftertaste of the Tablet? at Week 3."|Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
126826|NCT00579982|Secondary|"Number of Participants Answering the Question How Would You Rate the Strength of the Flavor of the Tablet? at Week 3"|Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? [from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
126827|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied Were You With the Flavor of the Tablet? at Week 3"|Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
126828|NCT00579982|Secondary|Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3|Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? [from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)]|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
126829|NCT00579982|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3"|Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]|Baseline, End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
126830|NCT00579982|Secondary|"Number of Participants Answering the Question Did the Tablets Dissolve Instantly (Yes or no)? at Week 3"|The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?|End of Study (Week 3) or Early Withdrawal|ITT||Number of participants|||Number
126831|NCT00579982|Secondary|Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3|Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.|Baseline, End of Study (Week 3 weeks) or at Early Withdrawal|ITT||Points on a scale||Standard Deviation|Mean
126832|NCT00579982|Secondary|Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3|Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).|Baseline, End of Study (Week 3) or at Early Withdrawal|ITT||Points on a scale||Standard Deviation|Mean
126833|NCT00579982|Secondary|Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3|The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.|Baseline, End of Study (Week 3) or Early Withdrawal|ITT||Points on a subscale||Standard Deviation|Mean
126834|NCT00579982|Primary|Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.|The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.|Baseline, End of Study (Week 3) or Early Withdrawal|Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment.||Points on a subscale||Standard Deviation|Mean
126835|NCT00579813|Primary|Particpants||December 2009|||participants|||Number
126836|NCT00579670|Post-Hoc|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period: Within SmPC||Week 12|Within SmPC||Participants|||Number
126837|NCT00579670|Post-Hoc|Percent Change From Baseline to Final Visit in Body Weight: Within SmPC||Baseline, Week 12|Within SmPC||percent change||Standard Deviation|Mean
126838|NCT00579670|Post-Hoc|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126839|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126845|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126846|NCT00579670|Post-Hoc|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126847|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126848|NCT00579670|Post-Hoc|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participant|||Number
126849|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126850|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126851|NCT00579670|Post-Hoc|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?: Within SmPC"||Week 12|Within SmPC; N=participants with evaluable data for specified question at observation||Participants|||Number
126852|NCT00579670|Post-Hoc|PANSS - Composite Subscale: Within SmPC|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation||Scores on a scale||Standard Deviation|Mean
126853|NCT00579670|Post-Hoc|PANSS - Negative Subscale: Within SmPC|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation||Scores on a scale||Standard Deviation|Mean
126854|NCT00579670|Post-Hoc|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|Within SmPC; N=participants with evaluable data at observation||Scores on a scale||Standard Deviation|Mean
126855|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|Within SmPC||Participants|||Number
126856|NCT00579670|Post-Hoc|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Within SmPC population: participants in FAS population who received all doses within SmPC. Within SmPC defined as all PO doses up to and including 160 mg per day and all IM doses up to and including 40 mg per day.||Participants|||Number
126857|NCT00579670|Secondary|Percent Change From Baseline to Final Visit in Body Weight||Baseline, Week 12|Safety population = all subjects who received at least 1 dose of study medication.||percent change||Standard Deviation|Mean
126858|NCT00579670|Other Pre-specified|Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period||Week 12|FAS. Four subjects did not answer the question of continuation of treatment.||Participants|||Number
126859|NCT00579670|Secondary|"Number of Participants Answering the Question Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"||Week 12|FAS||Participants|||Number
126860|NCT00579670|Secondary|"Number of Participants Answering the Question How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"||Week 12|FAS||Participants|||Number
126861|NCT00579670|Secondary|"Number of Participants Answering the Question Overall, How Confident Are You That Taking This Medication is a Good Thing?"||Week 12|FAS||Participants|||Number
126862|NCT00579670|Secondary|"Number of Participants Answering the Question How Convenient or Inconvenient is it to Take the Medication as Instructed?"||Week 12|FAS||Participants|||Number
126863|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"||Week 12|FAS||Participants|||Number
126864|NCT00579670|Secondary|"Number of Participants Answering the Question How Easy or Difficult is it to Use the Medication in Its Current Form?"||Week 12|FAS||Participants|||Number
126865|NCT00579670|Secondary|"Number of Participants Answering the Question To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"||Week 12|FAS||Participants|||Number
126960|NCT00578812|Secondary|Mean Neck Pain Visual Analog Scale|Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).|24 Months|per protocol||mm||Standard Deviation|Mean
126867|NCT00579670|Secondary|"Number of Participants Answering the Question To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"||Week 12|FAS||Participants|||Number
126868|NCT00579670|Secondary|"Number of Participants Answering the Question How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"||Week 12|||Participants|||Number
126869|NCT00579670|Secondary|"Number of Participants Answering the Question As a Result of Taking This Medication, do You Experience Any Side Effects at All?"||Week 12|||Participant|||Number
126870|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"||Week 12|FAS||Participants|||Number
126871|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"||Week 12|||Participants|||Number
126872|NCT00579670|Secondary|"Number of Participants Answering the Question How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"||Week 12|FAS||Participants|||Number
126873|NCT00579670|Secondary|PANSS - Composite Subscale|The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.|Baseline, Week 12|FAS||Scores on a scale||Standard Deviation|Mean
126874|NCT00579670|Secondary|PANSS - Negative Subscale|Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.|Baseline, Week 12|FAS||Scores on a scale||Standard Deviation|Mean
126875|NCT00579670|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.|Baseline, Week 12|FAS||Scores on a scale||Standard Deviation|Mean
126876|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)|Baseline, Week 12|FAS; Baseline Visit: 1 subject in the Ziprasidone >=160mg group had missing severity result. Final Visit: 2 subjects (1 subject in the Ziprasidone 120mg to <160mg and 1 subject in the Ziprasidone <80mg group) had missing severity results.||Participants|||Number
126877|NCT00579670|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|The Full Analysis Set (FAS) - all subjects who received at least 1 dose of study medication and have at least 1 efficacy measurement.||Participants|||Number
126878|NCT00579670|Primary|Summary of Most Frequently Used Concomitant Drug Treatments|Most frequently concomitant drug treatments used by >15 participants.|Baseline|All subjects randomized to a treatment group were included in this baseline analysis.||Participants|||Number
126879|NCT00579670|Primary|Summary of Metabolic Risk Factors||Baseline|All subjects randomized to a treatment group were included in this baseline analysis.||Participants|||Number
126880|NCT00579670|Primary|Summary of Schizophrenia|Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.|Baseline|All subjects randomized to a treatment group were included in the Baseline analysis.||Participants|||Number
126881|NCT00579501|Secondary|Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)|The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment.||percentage of participants|||Number
126882|NCT00579501|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.|Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.|Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment.||percentage of participants|||Number
126883|NCT00579345|Primary|Immunogenicity Assessment by Geometric Mean Titers (GMT).|Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.|Three weeks postvaccination|Per protocol set: this population consisted of all subjects in the Intention To Treat population (ITT) who had no major protocol violation as defined prior to analysis (ITT=enrolled subjects who received single dose of influenza vaccine(or 2 vaccines if receiving the pneumococcal vaccine) and provided one serum sample before and one after baseline)||Titers||95% Confidence Interval|Geometric Mean
126884|NCT00579345|Secondary|Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.|"Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96).~CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is > 2.5."|Three weeks postvaccination|Per Protocol||Ratio||95% Confidence Interval|Geometric Mean
126885|NCT00579345|Secondary|Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.|"Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96).~Seroconversion was defined as negative pre-vaccination titer (<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10)."|Three weeks postvaccination|Per Protocol Set||Subjects|||Number
126886|NCT00579345|Primary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.|One week postvaccination|Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data.||Subjects|||Number
126887|NCT00579345|Secondary|Number of Randomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site.|One week postvaccination|Safety Set||Subjects|||Number
126888|NCT00579345|Secondary|Number of Unrandomized Participants Reporting Local and Systemic Reactions.|Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.|One week postvaccination|Safety set.||Subjects|||Number
126889|NCT00579254|Primary|Change in Systolic and Diastolic Blood Pressure|No efficacy results were available from this terminated study.|Baseline, 24 weeks|||mmHg (millimeters of mercury)||Standard Deviation|Mean
126890|NCT00579137|Secondary|Number of Patients With Grade III to IV Acute GVHD||100 days|||participants|||Number
126891|NCT00579137|Secondary|Number of Patients With Grade III or IV Toxicity||100 days|||participants|||Number
126892|NCT00579137|Secondary|Patients Alive at 1 Year||1 Year|||participants|||Number
126893|NCT00579137|Primary|Number of Patients With Donor Engraftment||100 Days|||participants|||Number
126894|NCT00579111|Secondary|Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity||100 days|||participants|||Number
126895|NCT00579111|Primary|Number of Patients With Successful Donor Engraftment|Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.|100 days|||participants|||Number
126896|NCT00579098|Secondary|Change in Lipid Levels|The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated.|Baseline and 3 months|Intent-to-treat analysis population.||mg/dL||Standard Deviation|Mean
126897|NCT00579098|Secondary|Change in Mean Quality of Life Score|A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group.|Baseline and 3 months|Intent-to-treat analysis population.||units on a scale||Standard Deviation|Mean
126898|NCT00579098|Secondary|Change in Mean C-Reactive Protein Level||Baseline and 3 months|Intent-to-treat analysis population.||mg/dL||Standard Deviation|Mean
126899|NCT00579098|Secondary|Percentage of Subjects Without Atrial Arrhythmia at 3 Months|Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter.|Baseline through 3 months|Intent-to-treat analysis population.||Percentage of subjects|||Number
126900|NCT00579098|Primary|Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months|Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group).|Baseline through 3 months|Intent-to-treat analysis population.||Percentage of subjects|||Number
126901|NCT00579059|Secondary|Range of Motion - Flexion|This represents how far the patients were able to flex the knee in the clinic at 1-year.|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.||degrees||Full Range|Mean
126902|NCT00579059|Primary|Knee Society Function Score|"The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered Excellent, 60-89 is considered Good, 30-59 is considered fair, and 0-29 is considered poor."|1 Year|This population represents patients that returned for follow-up at 1-year post-op per protocol.||knees|||Number
126903|NCT00578968|Secondary|Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||percentage of change in HR||Standard Deviation|Mean
126948|NCT00578812|Secondary|Nurick's Classification of Disability (Myelopathy)|Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick’s classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient “maintained” if their Nurick classification grade remained the same or “improved” if it decreased from baseline to 24 months.|24 Months|Per protocol with extended windows||participants|||Number
126904|NCT00578968|Secondary|Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||percentage of change in SVI||Standard Deviation|Mean
126905|NCT00578968|Primary|Pretreatment Peak Exercise SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||mL/m^2||Standard Deviation|Mean
126906|NCT00578968|Secondary|Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||percentage of change in CI||Standard Deviation|Mean
126907|NCT00578968|Primary|Pretreatment Peak Exercise CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/min/m^2||Standard Deviation|Mean
126908|NCT00578968|Secondary|Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.||percentage of change in VO_2||Standard Deviation|Mean
126909|NCT00578968|Secondary|Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|first visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/min||Standard Deviation|Mean
126910|NCT00578968|Secondary|Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal control population did not take part in this measurement.||Percentage of change in HR||Standard Deviation|Mean
126911|NCT00578968|Secondary|Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||bpm||Standard Deviation|Mean
126912|NCT00578968|Secondary|Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.||Percentage of change in SVI||Standard Deviation|Mean
126913|NCT00578968|Secondary|Pretreatment Resting SVI|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||mL/m^2||Standard Deviation|Mean
126914|NCT00578968|Secondary|Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.||percentage of change in CI||Standard Deviation|Mean
126915|NCT00578968|Secondary|Pretreatment Resting CI|Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/min/m^2||Standard Deviation|Mean
126916|NCT00578968|Secondary|Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal controls did not take part in this measurement.||Percentage of change in FEV_1||Standard Deviation|Mean
126917|NCT00578968|Secondary|Pretreatment Resting FEV_1|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||L/sec||Standard Deviation|Mean
126918|NCT00578968|Secondary|Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease. Percentage change = final value - initial value/initial value x 100|first visit of first study period, first visit of second study period (approximately 6 weeks later)|Normal Control population did not take part in this measurement.||percentage of change in FVC||Standard Deviation|Mean
126919|NCT00578968|Secondary|Pretreatment Resting FVC as Percentage of Predicted FVC|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||percentage of predicted FVC||Standard Deviation|Mean
126920|NCT00578968|Primary|Baseline Resting Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).|first visit of first study period|||mL/m^2||Standard Deviation|Mean
126921|NCT00578968|Primary|Baseline Resting Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|First visit of first study period|||L/min/m^2||Standard Deviation|Mean
126922|NCT00578968|Secondary|Pretreatment Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First study visit of first study period|Normal Control population did not take part in this measurement. Researchers collected this data V1 study period 1, but randomized subjects after V4 study period 1.||Liters||Standard Deviation|Mean
126923|NCT00578968|Secondary|Baseline Peak Exercise Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).|second visit of first study period|||mL/m^2||Standard Deviation|Mean
126924|NCT00578968|Secondary|Baseline Peak Exercise Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|second visit of first study period|||L/min/m^2||Standard Deviation|Mean
126925|NCT00578968|Secondary|Baseline Peak Exercise Maximal Oxygen Consumption (VO_2)|VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.|second visit of first study period|||L/min||Standard Deviation|Mean
126926|NCT00578968|Secondary|Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups|Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.|first visit of first study period, second visit of first study period|||beats per minute (bpm)||Standard Deviation|Mean
126927|NCT00578968|Secondary|Baseline Resting FEV_1 as Percentage of Predicted FEV_1|Predicted normal values for Forced Expiratory Volume in 1 second can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FEV_1/predicted FEV_1 X 100.|first visit of first study period|||percentage of predicted FEV_1||Standard Deviation|Mean
126928|NCT00578968|Secondary|Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)|FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.|first visit of first study period|||L/sec||Standard Deviation|Mean
126929|NCT00578968|Secondary|Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)|Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.|First visit of first study period|||percentage of predicted FVC||Standard Deviation|Mean
126930|NCT00578968|Secondary|Baseline Resting Forced Vital Capacity (FVC)|Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.|First visit of first study period|All COPD participants were included, prior to randomization in the second period of the study.||Liters||Standard Deviation|Mean
126949|NCT00578812|Secondary|Patient Satisfaction|Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).|24 Months|Per protocol||mm||Standard Deviation|Mean
126931|NCT00578942|Secondary|Response|"Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR).~CR for malignant hematologic diseases is met if all the following are met for >/= 1 month:~absence of pathologic lymphadenopathy by physical and radiographic exam~absence of constitutional symptoms due to disease~Polymorphonuclear leukocyte count > 1,500/uL; platelet count >50,000/uL; and hemoglobin >10.0 g/dL~bone marrow aspirate/biopsy done after (a) through (c) have been met, >/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc.~molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc.~CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values."|1 year|Cohort of subjects on the study who actually received >/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have >grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion.||participants|||Number
126932|NCT00578942|Primary|Overall Survival (OS)|Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.|Up to 12 years; participants were followed for the duration of the study, an average of 8 years|Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death. One participant who was lost to follow-up after 14 months was not included. Participants were followed for the duration of the study, an average of 8 years.||months alive post-infusion||Full Range|Mean
126933|NCT00578942|Primary|Toxicity|Acute graft versus host disease (GVHD) was graded according to the consensus criteria and NCI common terminology criteria for adverse events (CTCAE) v2.0 or 3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the nonablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently.|1 year|Cohort of subjects who received >/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg.Subjects were grouped into 4 categories within the range of cell doses delivered and were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive.||participants|||Number
126934|NCT00578929|Secondary|Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)|"Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days."|Baseline through 2 weeks after randomization|||Percent change of TOSS from baseline||Standard Error|Least Squares Mean
126935|NCT00578929|Primary|Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)|"Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.~The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days."|Baseline through 2 weeks after randomization|||Percent change of TNSS from baseline||Standard Error|Least Squares Mean
126936|NCT00578903|Secondary|Number of Subjects Alive at 2 Years Post Transplant||2 years|||participants|||Number
126937|NCT00578903|Secondary|Number of Subjects Alive at 1 Year Post Transplant||1 year|||participants|||Number
126938|NCT00578903|Secondary|Number of Patients With Chronic GVHD at 2 Years Post Transplant||2 years|||participants|||Number
126939|NCT00578903|Secondary|Number of Patients With Acute GVHD at 100 Days Post Transplant||100 days|||participants|||Number
126940|NCT00578903|Secondary|Number of Patients With Engraftment Rate at 100 Days Post Transplant|Absolute neutrophil count greater than 0.5 X 10^9/ml for at least 3 days|100 days post transplant|||participants|||Number
126941|NCT00578903|Primary|Number of Subjects Alive at 100 Days Post Transplant||100 days|||participants|||Number
126942|NCT00578864|Secondary|Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.|The first of the two events (relapse or death) was chosen to represent disease free survival|3 years|||participants|||Number
126943|NCT00578864|Secondary|Percentage of Patients Who Have Surgery After the Second Cycle of Induction Therapy|the measure is the number of patients who have surgery after two cycles of induction|2 months|||participants|||Number
126944|NCT00578864|Secondary|Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.||3 years|number of survival||participants|||Number
126945|NCT00578864|Primary|Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.|If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC > 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia|2 months|||participants|||Number
126946|NCT00578864|Primary|Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.||2 months|||participants|||Number
126947|NCT00578812|Secondary|Flexion/Extension Range of Motion at the Operative Level|Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.|24 Months|Per Protocol||degrees||Standard Deviation|Mean
126962|NCT00578812|Primary|Individual Patient Overall Success|Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.|24 Months|Per Protocol||participants|||Number
126963|NCT00578786|Primary|Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN)|The number of participants with serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) falling into the following categories: >3.0 and </= 5.0 x ULN, >5.0 and </= 8.0 x ULN, and >8.0 x ULN. Includes the highest value per participant across all visits as well as values from early termination visits.|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 blinded dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||participants|||Number
126964|NCT00578786|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||percent probability (KM estimate)||95% Confidence Interval|Number
126965|NCT00578786|Secondary|Percentage of Participants With Failure-Free Treatment Status|Treatment failure was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to ambrisentan in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Baseline to Year 4|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||percent probability (KM estimate)||95% Confidence Interval|Number
126966|NCT00578786|Secondary|Percentage of Participants With No Clinical Worsening of PAH|Clinical worsening of PAH was defined as the time from randomization to ambrisentan therapy to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, addition of approved prostanoid therapy, study withdrawal due to the addition of other clinically approved PAH therapeutics, or study withdrawal due to 2 or more early escape criteria (for subjects randomized to AMB in NCT00423748 or NCT00423202). Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||percent probability (KM estimate)||95% Confidence Interval|Number
126967|NCT00578786|Secondary|Change From Baseline to Week 36 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 36|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
126968|NCT00578786|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
126969|NCT00578786|Secondary|Change From Baseline to Week 12 in SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General US population mean and SD. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 12|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
126970|NCT00578786|Secondary|Baseline SF-36 Health Survey Scales for the Combined Ambrisentan Group|The 8 scales of the SF-36 Health Survey measured included physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health, and the summary measures included physical health and mental health. Scores for each scale are transformed and the transformed scores range from 0 (worst health) to 100 (best health). The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline|All participants were combined into one group for this analysis (all doses) and an observed-case approach was used.||units on a scale||Standard Deviation|Mean
126987|NCT00578617|Primary|Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up|Documentation of atrial fibrillation using a cardiac event recorder|12 months after intervention|||participants|||Number
127042|NCT00578227|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse events include any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period following any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
126971|NCT00578786|Secondary|Change From Baseline to Year 3 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. Missing values were imputed using LOCF based on post-baseline observations.||participants|||Number
126972|NCT00578786|Secondary|Change From Baseline to Year 2 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values were imputed using LOCF based on post-baseline observations.||participants|||Number
126973|NCT00578786|Secondary|Change From Baseline to Year 1 in World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values imputed using LOCF based on post-baseline observations.||participants|||Number
126974|NCT00578786|Secondary|Baseline World Health Organization (WHO) Functional Class|WHO Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possible at rest.|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||participants|||Number
126975|NCT00578786|Secondary|Change From Baseline to Year 3 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||units on a scale||Standard Deviation|Mean
126976|NCT00578786|Secondary|Change From Baseline to Year 2 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||units on a scale||Standard Deviation|Mean
126977|NCT00578786|Secondary|Change From Baseline to Year 1 in Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 1|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||units on a scale||Standard Deviation|Mean
126978|NCT00578786|Secondary|Baseline Borg Dyspnea Index|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline|All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study.||units on a scale||Standard Deviation|Mean
127157|NCT00577824|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||mg/dL||Standard Error|Mean
126979|NCT00578786|Secondary|Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 3|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
126980|NCT00578786|Secondary|Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Year 2|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
126981|NCT00578786|Secondary|Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). The last-observation-carried-forward (LOCF) imputation method was used. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving AMB in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 48|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
126982|NCT00578786|Secondary|Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.). Missing values were imputed using LOCF method based on post-baseline observations. Baseline (BL) values from the screening/randomization visit of the 2 prior studies defined the BL of this long-term analysis for those receiving ambrisentan in the prior studies. The Screening/Randomization Visit of the present study was the BL for subjects receiving placebo in the prior studies.|Baseline to Week 24|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
126983|NCT00578786|Primary|Frequently Reported (15% or More Overall) Adverse Events by Severity|The primary endpoint of this study is the incidence and severity of adverse events associated with long-term exposure to AMB in participants with PAH. The most frequently occurring adverse events (occurring in 15% or more of the participants in the combined group) are presented, by severity, that began after entering this extension study. Adverse events that were serious are included. Adverse events are coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Version 6.1 and are presented by MedDRA preferred term. Severity was graded as follows: mild (AE did not interfere with routine activities; subject may have experienced slight discomfort), moderate (AE interfered with routine activities; subject may have experienced significant discomfort), and severe (AE made it impossible to perform routine activities; subject may have experienced intolerable discomfort or pain).|Baseline to Week 295|Safety Analysis Set: Includes all participants who received at least 1 dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Treatment group assignments for the safety analysis set were based upon the highest dose of AMB received at any time during the parent or extension studies.||participants|||Number
126984|NCT00578786|Secondary|Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test|The 6-minute walk distance (6MWD) test was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.).|Baseline|All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward.||Meters||Standard Deviation|Mean
126985|NCT00578734|Secondary|Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days||Up to 14 days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.||days||95% Confidence Interval|Least Squares Mean
126986|NCT00578734|Primary|Duration of Mechanical Ventilation Through 14 Days|Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.|Up to 14 Days|The sample size calculation was based on historical data and expected treatment effect. The primary efficacy analysis was for the intent-to-treat population, defined as all randomized subjects (N=165). A supportive population (N=134) of subjects without a major protocol violation that could impact efficacy was also used for efficacy analyses.||days||95% Confidence Interval|Least Squares Mean
126988|NCT00578565|Secondary|Percentage of Change in Health Associated Quality of Life From Baseline to 48 Weeks|The percentage change from baseline to week 48 in a participant's perception of the impact of health on his or her quality of life was collected on the Health Assessment Questionnaire (HAQ). The HAQ measures a person's ability to function with arthritis. The questionnaire is divided into 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip and Activities) which include several questions for each category. The category score is determined by the highest score of the set of questions for each category. The disability score is determined by adding the scores for all categories and dividing by 8. The disability scale ranges from 0 (best - without any difficulty) to 3 (worst - unable to do much).|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||percentage of change||Full Range|Mean
126989|NCT00578565|Primary|Change in Forced Vital Capacity (FVC) From Baseline to 48 Weeks|FVC is one measure of pulmonary function. For FVC, worsening was defined as decrease of at least 10% and improvement was defined as increase of at least 10%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||participants|||Number
126990|NCT00578565|Secondary|Change in RA Disease Activity From Baseline to 48 Weeks Using the DAS28 Score.|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||percentage of change||Full Range|Mean
126991|NCT00578565|Secondary|Assessment of RA Disease Activity Scores as Measured by the DAS28 Score at Baseline and 48 Weeks|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||units on a scale||Full Range|Mean
126992|NCT00578565|Secondary|Change in Lung Fibrosis Score as Observed on High Resolution Computerized Tomography (HRCT) Scans, From Baseline to 48 Weeks|Three serial HRCT scans of each patient were scored independently and simultaneously by two core radiologists, who were blinded to the sequence in which three scans were obtained (at screening, 24 and 48 weeks). The HRCT scoring sheet scored different domains of abnormality such as, linear opacities, consolidation, ground-glass density, etc. Radiographers reported composite impression based on scoring according to worsening, no worsening or improvement of relevant domains.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||participants|||Number
126993|NCT00578565|Primary|Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks|DLco is one pulmonary function measure. For DLco, worsening was defined as decrease of at least 15% and improvement was defined as increase of at least 15%.|baseline, 48 weeks|Three participants of the 10 enrolled withdrew or died before the end of the study.||participants|||Number
126994|NCT00578552|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question “Have you used any type of tobacco, even a puff, in the past 7 days?” and (b) Expired Carbon Monoxide equal or less then 8 parts per million.|12 weeks following start of medication|||participants|||Number
126995|NCT00578539|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol|1 year|Only 13 of the 24 patients enrolled were included in this analysis as only 13 patients have Treg values at 1 year.||percentage of total CD4+ cells||Inter-Quartile Range|Median
126996|NCT00578461|Primary|Median Percentage of Treg Cells at 1 Year Post Transplant|The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up.|1 Year|Only 20 of the 26 patients enrolled were included in this analysis as only 20 patients have Treg values at 1 year.||percentage of total CD4+ cells||Inter-Quartile Range|Median
126997|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by CTLA-4. Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Kynurenine was measured in micromoles (µM).|Day 1 to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.||µM||Standard Deviation|Mean
126998|NCT00578448|Secondary|Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants|Indoleamine 2,3 dioxygenase (IDO) is a tryptophan catabolizing enzyme that can be induced in antigen-presenting cells by the engagement of B7 by cytotoxic lymphocyte antigen 4 (CTLA-4). Tryptophan depletion in cellular microenvironments has an inhibitory effect on T cells and may be part of a broader immuno-regulatory effect of IDO induction. The IDO activity was determined by measuring the quantity of tryptophan and its metabolite, kynurenine, in serum samples using a validated high performance liquid chromatography (HPLC) method. Baseline is defined as pre-dose. Tryptophan was measured in micromoles (µM)|Baseline to Day 364|Number analyzed for Baseline, Days 5, 28, 112, 168, 364 = 12, 11, 11, 10, 10, and 10, respectively.||µM||Standard Deviation|Mean
127055|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HBs Antibodies|Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.|At month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination.||subjects|||Number
126999|NCT00578448|Secondary|Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants|Acute rejection of transplant defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. Graft loss was defined as either functional loss or physical loss. Day 1 is day of transplantation.|Day 1 up to 4 years post transplantation|All treated participants were analyzed during the planned 3 year study N=12. Only 9 participants entered the LTE so N=9 for LTE.||participants|||Number
127000|NCT00578448|Primary|Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. T-HALF was calculated as ln2/Lz, where Lz is the absolute value of the slope of the terminal log-linear phase. T-HALF is measured in hours (h).|Day 84 to Day 112|||hours||Standard Deviation|Mean
127001|NCT00578448|Primary|Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. Vss was calculated by dividing the dose by AUC and multiply the mean residence time (MRT). Vss was adjusted to body weight and measured as liter per kilogram body weight (l/kg).|Day 84 to Day 112|||l/kg||Standard Deviation|Mean
127002|NCT00578448|Primary|Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. CLT was calculated by dividing the dose by AUC(TAU) and was adjusted to body weight. CLT was measured as milliliter per time per kg body weight (mL/h/kg).|Day 84 to Day 112|Participants who were treated and had PK data.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
127003|NCT00578448|Secondary|Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population|Blood samples were obtained pre and post dose at designated time points up to Day 112 and thereafter, pre-dose samples were obtained at Days 168 and 364, and then once yearly up to end of Year 3. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The trough serum concentration (Cmin), was recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Cmin was measured as micrograms per milliliter (µg/mL).|Day 1 to Day 1092|Number of participants (N) analyzed = 11 for Days 5, 14,and 28; and 12 for Day 56. Days 84, 112, 168, 364 N=10.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
127004|NCT00578448|Primary|Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population|At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). The area under the concentration-time curve in one dose interval [AUC(TAU), where TAU = 4 weeks] were calculated using the mixed log-linear trapezoidal algorithm in Kinetica. Actual sampling times were used for PK calculations. AUC (TAU) was measured as micrograms multiplied by time(h) per milliliter (µg*h/mL).|Day 82 to Day 112|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
127005|NCT00578448|Primary|Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Tmax measured in hours (h). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 (h) on Day 112 . The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations.|Day 84 to Day 112|1 participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Tmax, Number of participants analyzed (N)=9.||hours||Full Range|Median
127016|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.||units on a scale||Standard Error|Mean
127056|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titers below 3.3 mIU/mL.||mIU/mL||95% Confidence Interval|Geometric Mean
127158|NCT00577824|Secondary|Change in Body Weight|Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||kg||Standard Error|Least Squares Mean
127006|NCT00578448|Primary|Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population|Cmax, Cmin are measured in micrograms per milliliter (µg/mL). At Day 84, blood samples obtained from pre-dose (0 hour) and ended at 672 hour (h) on Day 112. Serum samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method. Individual participant PK parameters were derived from serum concentration versus time data using a non-compartmental method, using a validated PK analysis program (KineticaTM 4.4.1 within the eToolbox [version 2.6.1]). Actual sampling times were used for PK calculations. The Cmax, and the Cmin were recorded directly from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria, which is also referred to as adjusted R-squared. Values below lower limits of quantification (LLQ), 0.003 µg/mL, were set to 0.0015 for computation of summary statistics.|Day 84 to Day 112|One participant excluded from analysis of Cmax and Tmax due to a very high concentration value (it was considered an outlier) therefore, for Cmax, Number of participants analyzed (N)=9.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
127007|NCT00578448|Primary|Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population|Pharmacokinetic (PK) sampling started from pre-dose (0 hour) on Day 84 and ended at 672 hour (h) on Day 112 (between Weeks 12 to 16). The samples were analyzed for belatacept by enzyme-linked immunosorbent assay (ELISA) using a validated method and measured as nanograms/milliliter (ng/mL). Less than the lower limit of quantification (LLQ), 3.000 ng/mL concentration value was treated as missing.|Day 84 to Day 112|Number (N) of participants analyzed for each collection time was 10, except for time 0.50 h, which was missing 1 participant. Therefore Number (N) for Time 0.50 h = 9.||ng/mL||Standard Deviation|Mean
127008|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127009|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|once pre and once post LFMS treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127010|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127011|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127012|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127013|NCT00578383|Primary|Visual Analog Scale (VAS) in Subjects With Bipolar Depression|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127014|NCT00578383|Primary|Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127015|NCT00578383|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127017|NCT00578383|Secondary|Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.|20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.||units on a scale||Standard Error|Mean
127018|NCT00578383|Secondary|Visual Analog Scale (VAS): Combined Diagnostic Groups.|Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores.||units on a scale||Standard Error|Mean
127019|NCT00578383|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.|A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.|Once just before and once just after treatment|Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.||units on a scale||Standard Error|Mean
127020|NCT00578331|Secondary|Average Number of Days of Rescue Medication Taken||Month 1 through Month 12|12 patients had missing average use of rescue medication data.||Days||Standard Deviation|Mean
127021|NCT00578331|Primary|Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire|Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.|day 30|29 patients had missing mean patient-rated relief assessment data.||Unit on PRRA scale||Standard Deviation|Mean
127022|NCT00578318|Primary|Attendance at First Depression Treatment Appointment|Patients were randomized to the intervention or a delayed control group. The primary outcome was bifurcated as yes or no to specify whether or not the patient attended the first available depression treatment appointment scheduled after he/she completed the AAKOMA protocol. The average time to attendance at the first session was approximately 3-4 weeks and during this intermediate time between completion of the protocol and initiation of treatment all patients were followed by study staff).|Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)|||participants|||Number
127023|NCT00578305|Secondary|Adverse Events (AEs), Laboratory Parameters, C-reactive Protein, ESR.||Throughout study||||||
127024|NCT00578305|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
127025|NCT00578305|Secondary|Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures|Correlation coefficients of magnetic resonance imaging erosion, synovitis, and osteitis scores and clinical outcome measures of swollen joint count (SJC), tender joint count (TJC), C-reactive protein level (CRP), erythrocyte sedimentation rate (ESR), a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (GH), Disease Activity Score 28-C-reactive protein (DAS28-CRP), and Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) are reported. Not all of these variables were specified as primary or secondary Outcome Measures in the study protocol and were not individually analyzed.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Correlation coefficient|||Number
127026|NCT00578305|Secondary|Percentage of Participants Achieving a Major Clinical Response at Week 52|A major clinical response was defined as an improvement of at least 70% in the American College of Rheumatology score from Baseline at Week 52. Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate participant and physician assessments of participant disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”); participant assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein level.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127027|NCT00578305|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52|Improvement must be seen in tender and swollen joint counts (28 assessed joints; Joints were evaluated and classified as swollen or not swollen and tender or not tender based on pressure and joint manipulation upon physical examination) and in at least 3|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127040|NCT00578279|Primary|The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection|Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.|baseline up to 1 year|||units on a scale||Standard Deviation|Mean
127028|NCT00578305|Secondary|Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52|The percentage of participants in remission of their rheumatic arthritis at Weeks 24 and 52, as measured by a DAS28 score < 2.6, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127029|NCT00578305|Secondary|Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52|The percentage of participants who had low rheumatic arthritis disease activity at Weeks 24 and 52, as measured by a DAS28 score ≤ 3.2, is reported. DAS28 is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]), and CRP = C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127030|NCT00578305|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52|Change of the DAS28 score from Baseline was used to determine the EULAR responses. For a post-Baseline score ≤ 3.2, a change from Baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-Baseline score > 3.2 to ≤ 5.1, a change from Baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-Baseline score > 5.1, a change from Baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-Baseline scores > 3.2. DAS28=(0.56×√(TJC28))+(0.28×√(SJC28))+(0.7×log(CRP))+(0.014×GH), where TJC28=tender joint count (JC) and SJC28=swollen JC (28 joints), GH=a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end=no disease activity, right end=maximum disease activity), and CRP=C-reactive protein level. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127031|NCT00578305|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, C-reactive protein level (CRP), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(CRO)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints, GH = a participant’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
127032|NCT00578305|Secondary|Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52|There were 2 definitions of improvement in osteitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging osteitis score from Baseline > than the smallest detectable change. The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127033|NCT00578305|Secondary|Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52|There were 2 definitions of improvement in synovitis. A participant met the criterion for definition 1 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > 0.5. A participant met the criterion for definition 2 when there was a drop in the magnetic resonance imaging synovitis score from Baseline > than the smallest detectable change. The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI (RAMRIS) scoring system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127041|NCT00578227|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
127159|NCT00577824|Secondary|Change in Fasting Blood Glucose|Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||mg/dL||Standard Error|Least Squares Mean
127034|NCT00578305|Secondary|Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52|There were 2 definitions of no progression/no worsening in bone erosion. A participant met the criterion for definition 1 when there was a change in the magnetic resonance imaging erosion score ≤ 0. A participant met the criteria for definition 2 when there was either (1) no change from Baseline in the MRI erosion score, (2) an increase in erosion score and the size of the increase in score was smaller than the smallest detectable change, or (3) a drop in the erosion score. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127035|NCT00578305|Secondary|Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52|No newly eroded joints was defined as no new erosions in joints which were scored 0 at baseline. The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Percentage of participants|||Number
127036|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52|The osteitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% increase in the volume of the peripheral 1 cm of original (eroded + residual) articular bone using the following scale: 0.0=normal, no osteitis; 0.5=1-17% involvement of original articular bone; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% involvement of original articular bone. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
127037|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52|The synovitis score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images of 3 wrist regions and 5 metacarpophalangeal joints in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 3 with each integer unit increment representing a 33% enhancement of the maximum volume of enhancing tissue in the synovial compartment using the following scale: 0.0=normal, no synovitis; 0.5=1-17% estimated volume of enhancement; 1.0=18-33%; 1.5=34-50%; 2.0=51-67%; 2.5=68-83%; 3.0=84-100% estimated volume of enhancement. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more synovitis. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
127038|NCT00578305|Secondary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
127039|NCT00578305|Primary|Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24|The erosion score was determined according to the Outcome Measures in Rheumatology (OMERACT) rheumatoid arthritis MRI scoring (RAMRIS) system in magnetic resonance images with and without gadolinium of 15 anatomical locations in each wrist and 10 locations in each hand in the hand and wrist with the most arthritic activity. If there was no difference in disease activity between the hands, the dominant hand was used. Images were assessed by 2 experienced blinded musculoskeletal radiologists. Each location was scored in 0.5 increments from 0 to 10 with each integer unit increment representing a 10% loss of articular bone using the following scale. 0.0=normal, no erosion; 0.5=1-5% erosion; 1.0=6-10% erosion; 1.5=11-15% erosion; 2.0=16-20% erosion; etc, up to 10.0=96-100% erosion. The individual scores were summed and normalized to a range of 0 to 100 with a higher score indicating more erosion. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants and received any part of an infusion of study medication during the main study.||Units on a scale||Standard Deviation|Mean
127427|NCT00576420|Secondary|Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line|Any rebleeding requiring surgical reexploration|Postoperative through day 30 ± 5|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127043|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the safety follow-up (from Month 7 up to Month 12)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
127044|NCT00578227|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the active phase of the study (up to Month 7)|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
127045|NCT00578227|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.|During the 7-day period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
127046|NCT00578227|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.|During the 7-day period (Day 0-6) following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
127047|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||EL.U/mL||95% Confidence Interval|Geometric Mean
127048|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||subjects|||Number
127049|NCT00578227|Secondary|Anti-HBs Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs before vaccination, i.e. with antibody titers below 3.3 mIU/mL.||mIU/mL||95% Confidence Interval|Geometric Mean
127050|NCT00578227|Secondary|Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies|"Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.~A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL."|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs with antibody titers below 3.3 mIU/mL.||subjects|||Number
127051|NCT00578227|Secondary|Anti-HAV Antibody Titers|Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.||mIU/mL||95% Confidence Interval|Geometric Mean
127052|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-HAV Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|One month after the second dose of vaccine|Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.||subjects|||Number
127053|NCT00578227|Secondary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||EL.U/mL||95% Confidence Interval|Geometric Mean
127054|NCT00578227|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||subjects|||Number
127057|NCT00578227|Primary|Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||EL.U/mL||95% Confidence Interval|Geometric Mean
127058|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.||subjects|||Number
127059|NCT00578227|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titer greater than or equal to 3.3 mIU/mL.||subjects|||Number
127060|NCT00578227|Primary|Anti-Heptatis A (HAV) Antibody Titers.|Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.|At Month 7|Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).||mIU/mL||95% Confidence Interval|Geometric Mean
127061|NCT00578227|Primary|Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies|Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).||subjects|||Number
127062|NCT00578214|Secondary|Pulse Oximetry at 60 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient’s finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.||percentage of oxygenation||Standard Deviation|Mean
127063|NCT00578214|Secondary|Respiratory Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment.||breaths per minute||Standard Deviation|Mean
127064|NCT00578214|Secondary|Heart Rate at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||heart beats per minute||Standard Deviation|Mean
127065|NCT00578214|Secondary|Blood Pressure at 60 Minutes||60 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||mm Hg||Standard Deviation|Mean
127066|NCT00578214|Secondary|Pulse Oximetry at 30 Minutes|Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient’s finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.|30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||percentage of oxygenation||Standard Deviation|Mean
127067|NCT00578214|Secondary|Respiratory Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment.||breaths per minute||Standard Deviation|Mean
127068|NCT00578214|Secondary|Heart Rate at 30 Minutes||30 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the placebo arm did not complete this assessment.||heart beats per minute||Standard Deviation|Mean
127069|NCT00578214|Secondary|Blood Pressure at 30 Minutes||30 minutes after drug administration|||mm Hg||Standard Deviation|Mean
127070|NCT00578214|Secondary|Patient Cognitive Function at 120 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|120 minutes after drug administration|The analysis was done on the patients who completed the assessment. Two patients in the placebo arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
127071|NCT00578214|Secondary|Patient Cognitive Function at Baseline and 60 Minutes|Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).|baseline (prior to drug administration) and 60 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the prospective midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
127198|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)|0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
127072|NCT00578214|Primary|Patient Anxiety at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
127073|NCT00578214|Secondary|Patient Alertness at 60 and 120 Minutes|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|60 and 120 minutes after drug administration|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm and 1 patient in the prospective midazolam arm did not complete this assessment.||units on a scale||Standard Error|Mean
127074|NCT00578214|Secondary|Patient Alertness at Baseline|A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
127075|NCT00578214|Primary|Patient Anxiety at Baseline|A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).|Baseline (prior to drug administration)|The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm, 2 patients in the placebo arm, and 1 patient in the prospective midazolam arm did not complete this assessment.||units on a scale||Standard Deviation|Mean
127076|NCT00578175|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
127077|NCT00578175|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits|New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.|For approximately 6 months (Day 0-180)|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
127078|NCT00578175|Secondary|Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)|"Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel."|During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort.||subjects|||Number
127079|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
127080|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Varicella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
127081|NCT00578175|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash||During the 43-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
127082|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination|Fever was measured rectally.|During the 43-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
127083|NCT00578175|Secondary|Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination|Fever was measured rectally.|During the 15-day follow-up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
127084|NCT00578175|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4 day follow up period following vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.||subjects|||Number
127085|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127086|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127087|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127088|NCT00578175|Secondary|Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value|Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127428|NCT00576420|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127089|NCT00578175|Secondary|Number of Subjects With Vaccine Response to Havrix®|Vaccine response to Havrix® is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127090|NCT00578175|Secondary|Concentration of Antibodies to Rubella Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||International units per milliliter||95% Confidence Interval|Geometric Mean
127091|NCT00578175|Secondary|Concentration of Antibodies to Measles Virus|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
127092|NCT00578175|Secondary|Antibody Titers to Mumps Virus|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||titer||95% Confidence Interval|Geometric Mean
127093|NCT00578175|Primary|Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
127094|NCT00578175|Primary|Concentration of Antibodies to Hepatitis A Virus (HAV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
127095|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Rubella Virus|Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127096|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Measles Virus|Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127097|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Mumps Virus|Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127098|NCT00578175|Primary|Concentration of Antibodies to Varicella Virus (VZV)|Concentrations are given as Geometric Mean Concentrations (GMCs).|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
127099|NCT00578175|Primary|Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)|Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.|At Day 42 after vaccination|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
127100|NCT00578136|Secondary|The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management.|difference in time to rescue analgesic and the differences in side effects for the two groups.|immediate to 24 hours post-operatively|Time to first rescue dose of opioid medication.||minutes||Standard Deviation|Mean
127101|NCT00578136|Primary|The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia.|total postoperative opioid and any additional analgesic medications.|immediate to 24 hour post-operatively|||mg kg-1||95% Confidence Interval|Mean
127102|NCT00578071|Secondary|Pathological Complete Response Rates Associated With This Regimen.|Absence of residual viable tumor cells at the time of surgical resection of the esophagus performed 7-9 weeks following completion of chemoradiotherapy.|90 days|Surgery was determined according to risk factors, patient consent and resectability.||percentage of participants|||Number
127103|NCT00578071|Secondary|Overall Survival Rates for the Patients Studied on This Protocol.|Number of patients alive one year after completing study protocol treatment.|One year|||participants|||Number
127104|NCT00578071|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)||Within 30 days of the last day of radiation|All patients who received chemoradiation.||participants|||Number
127105|NCT00578071|Primary|Panitumumab Maximum Tolerated Dose in Milligrams (mg)||60 days|Per protocol and intention to treat (ITT).||mg|||Number
127121|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - To What Extent Are You Satisfied With the Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how satisfied they were with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127106|NCT00577889|Secondary|Confirmed Response Rate|"A confirmed response is defined as a complete response (CR) or partial response (PR) observed in two consecutive evaluations at least 4 weeks apart using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD.Evaluated using RECIST criteria."|2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment|||participants|||Number
127107|NCT00577889|Secondary|Time to Disease Progression|"The time to disease progression is defined as the time from registration to the time of confirmed disease progression using the Response Evaluation Criteria In Solid Tumors (RECIST). Estimated using the method of Kaplan-Meier.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers (CA 19-9 or CEA).~Partial Response (PR): At least a 30% decrease in the sum of largest dimension(LD) of target lesions taking as reference the baseline sum LD."|Time from registration to documentation of disease progression, assessed up to 2 years|||months||95% Confidence Interval|Median
127108|NCT00577889|Secondary|Overall Survival Time|Overall Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|Assessed up to 2 years from registration|||months||95% Confidence Interval|Median
127109|NCT00577889|Primary|Six Month Survival Rate|"A patient that is alive at 6 months is considered a treatment success. Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|6 months|||percentage of patients||95% Confidence Interval|Number
127110|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 46 Weeks|Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.||number of participants with complaints|||Number
127111|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 46 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|46 weeks|All participants who received at least one injection of study drug.||number of complaints|||Number
127112|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - What Could Be Done to Improve the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of what could be done to improve the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127113|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Remove the Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they remove the needle from their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127114|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - When Do You Attach a Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on when they attach a needle to their Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127115|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reusing Needles|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject response on whether or not they sometimes reuse needles.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127116|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis Away From Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are away from home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127117|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Helps Me Manage My Osteoporosis At Home|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen helps them manage their osteoporosis when they are at home.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127118|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Reduces My Reluctance to Take Injections|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of whether the Forteo B Pen reduces their reluctance to take injections.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127119|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Convenient for Me to Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how convenient Forteo B Pen was to use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127120|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - How Confident Are You That You Receive the Medication With Your Forteo B Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how confident they were that they received the medication with the Forteo B Pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127155|NCT00577824|Secondary|Change in High Density Lipoprotein Cholesterol (HDL-C)|Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.||mg/dL||Standard Error|Mean
127122|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Overall Ease of Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of the overall ease of use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127123|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Use the Forteo B Pen Instructions For Use|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to use the Forteo B Pen Instructions for Use.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127124|NCT00577863|Secondary|Summary of Subject Perceptions (Attributes) Assessments - Easy to Hold the Pen While Injecting|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to hold the pen while injecting.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127125|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Push the Black Injections Button to Administer the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to push the black injections button to administer the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127126|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Set the Dose|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to set the dose.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127127|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove a Used Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove a used needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127128|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Attach a New Needle|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to attach a new needle.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127129|NCT00577863|Secondary|Summary of Subject Perception (Attibutes) Assessments - Easy to Replace The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to replace the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127130|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove The Pen Cap|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen cap.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127131|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Learn to Use the Pen|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to learn to use the pen.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127132|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Read Label|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to read the label.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127133|NCT00577863|Secondary|Summary of Subject Perception (Attributes) Assessments - Easy to Remove Pen From Package|To assess overall subject perception of the device performance and acceptability through a questionnaire completed by all subjects at Visit 3. Subject perception of how easy it was to remove the pen from the package.|8 weeks|All participants who received at least one injection of study drug and who answered the question.||participants|||Number
127134|NCT00577863|Secondary|Summary of Subject Preference Assessments - Use of the User Manual/Instructions for Use That Came With the Pen|To assess subject preferences for use of the User Manual/Instructions for Use that came with the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127135|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Ease of Use|To assess subject preferences for overall ease of use for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127136|NCT00577863|Secondary|Summary of Subject Preference Assessments - Removing a Used Needle|To assess subject preferences for removing a used needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127156|NCT00577824|Secondary|Change in Low Density Lipoprotein Cholesterol (LDL-C)|Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)|baseline, week 24|Full analysis set; Last observation carried forward.||mg/dL||Standard Error|Mean
127137|NCT00577863|Secondary|Summary of Subject Preference Assessments - Assurance That Drug is Delivered|To assess subject preferences for assurance that drug is delivered for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127138|NCT00577863|Secondary|Summary of Subject Preference Assessments - Force on the Plunger Needed to Inject a Dose|To assess subject preferences for force on the plunger needed to inject a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127139|NCT00577863|Secondary|Summary of Subject Preference Assessments - Injecting a Dose|To assess subject preferences for injecting a dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127140|NCT00577863|Secondary|Summary of Subject Preference Assessments - Setting the Dose|To assess subject preferences for setting the dose for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127141|NCT00577863|Secondary|Summary of Subject Preference Assessments - Attaching a New Needle|To assess subject preferences for attaching a new needle for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127142|NCT00577863|Primary|Number of Subjects With Forteo B Pen Complaints at 8 Weeks|Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.||number of participants with complaints|||Number
127143|NCT00577863|Secondary|Summary of Subject Preference Assessments - Learning to Use the Pen|To assess subject preferences for learning to use the pen for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127144|NCT00577863|Secondary|Summary of Subject Preference Assessments - Overall Preference|To assess overall subject preferences for the Forteo 1.1 Pen or the Forteo B Pen through a questionnaire at Visit 2 completed by subjects who switch from the Forteo 1.1 Pen prior to the study entry to the Forteo B Pen during study participation.|4 weeks|All participants who received at least one injection of study drug and are currently using the Forteo 1.1 Pen who answered the question.||participants|||Number
127145|NCT00577863|Primary|Summary of Forteo B Pen Complaints at 8 Weeks|Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.|8 weeks|All participants who received at least one injection of study drug.||number of complaints|||Number
127146|NCT00577824|Secondary|Change in 1,5-anhydroglucitol|Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||mcg/mL||Standard Error|Mean
127147|NCT00577824|Secondary|Change in C-peptide|Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ng/mL||Standard Error|Mean
127148|NCT00577824|Secondary|Change in Serum Insulin|Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||mcU/mL||Standard Deviation|Mean
127149|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)|Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ratio||Standard Error|Mean
127150|NCT00577824|Secondary|Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)|Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ratio||Standard Error|Mean
127151|NCT00577824|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24|Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||mg/dL||Standard Deviation|Mean
127152|NCT00577824|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||ratio (cm/cm)||Standard Error|Mean
127153|NCT00577824|Secondary|Change in Waist Size|Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)|baseline, week 24|Full Analysis Set; Last Observation Carried Forward||cm||Standard Error|Mean
127154|NCT00577824|Secondary|Change in Triglycerides|Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)|baseline, week 24|Full analysis set; Last observation carried forward||mg/dL||Standard Error|Mean
127160|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 6.5%|Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only subjects whose HbA1c was >=6.5% at baseline were included.||percentage of participants|||Number
127161|NCT00577824|Secondary|Percentage of Patients Achieving HbA1c < 7.0%|Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)|24 weeks|Full analysis set; Last observation carried forward. Only those patients with HbA1c >=7% at baseline included.||percentage of participants|||Number
127162|NCT00577824|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|baseline, 24 weeks|Full analysis set; Last observation carried forward.||Percentage of hemoglobin||Standard Error|Least Squares Mean
127163|NCT00577772|Primary|Oro-cecal Transit Time as Measured by SmartPill|Oro-cecal transit time is the period of time needed by the head of the meal to reach the cecum, which is frequently used as an indicator of small intestinal transit time. Oro-cecal transit was to be determined simultaneously in the study subjects by both the SmartPill technique and the lactulose H_2BT technique.|baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline|Data were not analyzed as study was terminated early due to low enrollment.|||||
127164|NCT00577720|Secondary|Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population||Baseline and Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
127165|NCT00577720|Secondary|Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population||Baseline and Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
127166|NCT00577720|Primary|Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population||Baseline and Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
127167|NCT00577707|Secondary|To Determine the Response Rate, 3-year Overall Survival and Median Survival of Patients With Stage IB-IIIA NSCLC With a Known EGFR Mutation Receiving Neoadjuvant Chemotherapy and Erlotinib (and Adjuvant Erlotinib).||3 years||||||
127168|NCT00577707|Secondary|To Determine the Response Rate After 21 Days of Single Agent Erlotinib for Stage IB-IIIA NSCLC With a Known EGFR Mutation.||calculate the response rate after 21 days of single agent erlotinib||||||
127169|NCT00577707|Primary|To Determine the Pathologic Complete Response Rate for Patients With Stage IB-IIIA NSCLC With Tumors That Harbor an EGFR Mutation Treated With Neoadjuvant Chemotherapy + Erlotinib||Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.|||participants|||Number
127170|NCT00577655|Secondary|Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night and the number of puffs of rescue albuterol used during the night after going to bed. At the end of each day, the number of puffs of albuterol rescue medication used during the day were recorded.|Weeks 1, 2, 3|ITT population||Number of puffs per day||95% Confidence Interval|Mean
127171|NCT00577655|Secondary|Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning|Participants measured their PEF as trained by taking as deep a breath as possible, placing their mouth firmly around the mouthpiece of the flow meter to form a tight seal, and exhaling as hard and as fast as possible. Subjects repeated the process twice at intervals of approximately 30 seconds, and then recorded the highest of the three PEF values on the diary card.|Weeks 1, 2, 3|ITT population||Liters/minute||Standard Error|Mean
127172|NCT00577655|Secondary|The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Run-in (Days -21 to -1), Weeks 1, 2, 3|ITT population||awakenings/week||Standard Deviation|Mean
127173|NCT00577655|Secondary|Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3|"Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms were scored daily on a four-point scale:~0 = No symptoms occurred~1 = Symptom occurred but did not interfere with daily activity~2 = Symptom occurred but was sometimes annoying or interfered with daily activity~3 = Symptom present even at rest and was annoying or interfered with daily activity"|Weeks 1, 2, 3|ITT population.||units on a scale||Standard Error|Mean
127174|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+12% increase in PEF within 30 minutes of dose.~The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
127175|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+15% increase in PEF within 30 minutes of dose.~The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
127199|NCT00577473|Secondary|Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)|0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
127494|NCT00575146|Primary|Applicability as Measured by Discontinuation of Study Treatment Due to Intolerability|percentage of patients who discontinued diet due to intolerability|until progression for up to 12 months|||percent of participants|||Number
127176|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+12% increase in FEV1 within 30 minutes of dose.~The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
127177|NCT00577655|Secondary|Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+15% increase in FEV1 within 30 minutes of dose.~The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing|ITT||percentage of participants|||Number
127178|NCT00577655|Secondary|Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.~Time to maximum PEF is defined as the number of minutes required for the baseline PEF to increase to the highest PEF post-dose for the 6 hour observation period. Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|ITT population; Last Observation Carried Forward (LOCF) used for Day 22||minutes||95% Confidence Interval|Median
127179|NCT00577655|Secondary|Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters.~Time to maximum FEV1 is defined as the number of minutes required for the baseline FEV1 to increase to the highest FEV1 post dose during the 6 hour observation period.~Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Intent-To-Treat (ITT) population; Last Observation Carried Forward (LOCF) used for Day 22||minutes||95% Confidence Interval|Median
127180|NCT00577655|Secondary|Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case)|The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.|Days 1 and 22: 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)||percentage of predicted FEV1||Standard Error|Mean
127181|NCT00577655|Secondary|Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown.~The area under-the-effect curves for PEF were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 30±5 and 5±2 minutes prior to dosing Day 22: 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||Liters/Minute*Hours||Standard Error|Mean
127182|NCT00577655|Secondary|Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria.~The area under-the-effect curves for percent-predicted FEV1 were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times."|Baseline (Day 1 or Day 22: 35±5 and 10±2 minutes prior to dosing), Day 22 (5±2, 15±5, 30±5, 45±5, 60±10, 120±10, 240±10, and 360±10 minutes post-dosing or last observation)|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||Percent of Predicted FEV1 * Hours||Standard Error|Mean
127183|NCT00577655|Secondary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing on study days 1 and 22. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing|Observed cases||percentage change from baseline||Standard Error|Mean
127200|NCT00577473|Secondary|Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
127201|NCT00577473|Secondary|Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)|0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
127184|NCT00577655|Secondary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using test day baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values."|Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing|Observed cases (i.e. available data only)||percentage change from baseline||Standard Error|Mean
127185|NCT00577655|Primary|Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22|"The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|30±5 and 5±2 minutes prior to dosing, and at 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||percentage change from baseline||Standard Error|Mean
127186|NCT00577655|Primary|Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22|"The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs).~The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values.~The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age."|35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing on Day 22 or last observation|Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF)||percentage change from baseline||Standard Error|Mean
127187|NCT00577629|Secondary|Secondary Malignancies|The number of patients who develop a secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.|10 years||||||
127188|NCT00577629|Secondary|Overall Response|"Number of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period.~CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PR =~>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.~No increase should be observed in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.~Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders.~No new sites of disease should be observed."|up to 1 year|||participants|||Number
127189|NCT00577629|Secondary|Overall Survival|Overall Survival is measured from the first day of chemotherapy until death from any cause.|10 years||||||
127190|NCT00577629|Secondary|Disease-free Survival in Patients With a Complete Response (CR or CRu)|Disease-free survival is measured from the date of CR or CRu to date of relapse or death|10 years||||||
127191|NCT00577629|Primary|1 Year Progression-free Survival Rate|Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: >50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.|1 year|||percentage of participants||95% Confidence Interval|Number
127192|NCT00577512|Secondary|In Subjects Achieving a Response, to Find Out How Long the Response Will Last.||12 months||||||
127193|NCT00577512|Primary|Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.||12 months|||participant response|||Number
127194|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
127195|NCT00577473|Secondary|Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)|0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
127196|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 6|All Randomized Patients||Percentage of Participants|||Number
127197|NCT00577473|Secondary|Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)|0-generally well, 1-fair, 2-poor, 3-terrible|Week 3|All Randomized Patients||Percentage of Participants|||Number
127202|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 6|All Randomized Patients||Percentage of Participants|||Number
127203|NCT00577473|Secondary|Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients|PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.|Week 3|All Randomized Patients||Percentage of Participants|||Number
127204|NCT00577473|Secondary|Percentage of Patients Classified as Treatment Success at Week 3, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|3 weeks|ITT Population||Percentage of Participants|||Number
127205|NCT00577473|Primary|Percentage of Patients Classified as Treatment Success at Week 6, ITT Population|Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.|6 weeks|ITT Population||Percentage of Participants|||Number
127206|NCT00577460|Secondary|Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set|The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.|Baseline, 80 weeks|Treated Set - all patients dispensed drug and documented to have taken at least one dose||participants|||Number
127207|NCT00577460|Secondary|Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set|ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|OL Baseline and Week 80|||units on a scale||Standard Deviation|Mean
127208|NCT00577460|Secondary|Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||kg||Standard Deviation|Mean
127209|NCT00577460|Secondary|Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||kg||Standard Deviation|Mean
127210|NCT00577460|Secondary|Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||beats per minute||Standard Deviation|Mean
127211|NCT00577460|Secondary|Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||beats per minute||Standard Deviation|Mean
127212|NCT00577460|Secondary|Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
127213|NCT00577460|Secondary|Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
127214|NCT00577460|Secondary|Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
127215|NCT00577460|Secondary|Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set||OL Baseline and Week 80|Vital Signs Treated Set - All participants treated with study drug and have both baseline and week 80 vital sign data||mm Hg||Standard Deviation|Mean
127216|NCT00577460|Primary|Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events|The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.|80 weeks|Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)||Percentage of participants|||Number
127217|NCT00577460|Secondary|Number of Participants With Serious Adverse Events||80 weeks|The Treated Set (TS) included all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment||Patients|||Number
127218|NCT00577460|Secondary|Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline||OL baseline and week 80|Patients from Treated Set (all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment) and treated until week 80||Patients|||Number
127219|NCT00577460|Secondary|Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80||OL baseline and week 80|Patients from FAS with documentation of levodopa (L-DOPA) daily dose at week 80||Patients|||Number
127236|NCT00577460|Secondary|UPDRS II+III Change From Open Label (OL) Baseline|UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|OL Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80||Scores on a scale||Standard Error|Least Squares Mean
127220|NCT00577460|Secondary|Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80|PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD|OL baseline and week 80|Patients from FAS with values of PFS-16 score at week 80||Unit on a scale||Standard Error|Least Squares Mean
127221|NCT00577460|Secondary|UPDRS IV Total Score and Change From OL Baseline at Week 80|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|OL baseline and week 80|Patients from FAS with values of UPDRS IV at week 80||Unit on a scale||Standard Error|Least Squares Mean
127222|NCT00577460|Secondary|UPDRS III Total Score and Change From OL Baseline at Week 80|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|OL baseline and week 80|Patients from FAS with values of UPDRS III at week 80||units on a scale||Standard Error|Least Squares Mean
127223|NCT00577460|Secondary|UPDRS II Total Score and Change From OL Baseline at Week 80|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities|OL baseline and week 80|Patients from FAS with values of UPDRS II at week 80||units on a scale||Standard Error|Least Squares Mean
127224|NCT00577460|Secondary|UPDRS I Total Score and Change From OL Baseline at Week 80|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|OL baseline and week 80|Patients from FAS with values of UPDRS I at week 80||units on a scale||Standard Error|Least Squares Mean
127225|NCT00577460|Secondary|Number of Participants With Response in PGI-I for Early Morning Off Symptoms|"Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I for early morning off symptoms at week 32||Patients|||Number
127226|NCT00577460|Secondary|Number of Participants With Response in PGI-I|"Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much better were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders"|32 weeks|Patients from FAS with values of PGI-I at week 32||Patients|||Number
127227|NCT00577460|Secondary|Number of Participants With Response in CGI-I|"Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least much improved were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders"|32 weeks|Patients from FAS with values of CGI-I at week 32||Patients|||Number
127228|NCT00577460|Secondary|Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
127229|NCT00577460|Secondary|Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
127230|NCT00577460|Secondary|Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
127231|NCT00577460|Secondary|Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.|Baseline and week 80|Patients from FAS with values of on time during waking hours at week 80||percentage during waking hours||Standard Error|Least Squares Mean
127232|NCT00577460|Secondary|Number of Participants With Response in Percentage Off Time During Waking Hours|Response means >=20% improvement relative to OL baseline in the % off-time during waking hours|80 weeks|Patients from FAS with values of off time during waking hours at 80 weeks||Patients|||Number
127233|NCT00577460|Secondary|Percentage Off Time During Waking Hours Total Score: Change From Baseline|"Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).~A negative change implies improvement"|Baseline and week 80|Patients from FAS with values of UPDRS II+III at week 80||percentage during waking hours||Standard Error|Least Squares Mean
127234|NCT00577460|Secondary|Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time|A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|One week|Patients from FAS and who maintain the final dose of the previous study||Patients|||Number
127235|NCT00577460|Secondary|Number of Participants With UPDRS II+III Response|A response means an improvement of >=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Week 80|Patients from FAS with values of UPDRS II+III at week 80||Patients|||Number
127237|NCT00577460|Secondary|Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III|Unified Parkinson’s Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|One week|Patients from Full Analysis Set (FAS included all patients who were dispensed study medication, had received at least one dose of study drug and had provided any post-baseline efficacy assessment) and who maintain the final dose of the previous study||Patients|||Number
127238|NCT00577395|Secondary|Erosion Index of the Distal Radius|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|6 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|||||
127239|NCT00577395|Primary|Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius|"The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).~NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed."|12 months|Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.|||||
127240|NCT00577382|Secondary|Time to Progression|Time to progression based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).|The analysis dataset is comprised of treated patients. The majority of patients were off-treatment due to disease progression and thus the relevant observation time frame for this outcome is time on treatment.||months||95% Confidence Interval|Median
127241|NCT00577382|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).|The analysis dataset is comprised of treated patients.||months||95% Confidence Interval|Median
127242|NCT00577382|Secondary|Best Overall Response Rate|The best overall response rate was defined as achieving partial response (PR) or complete response (CR) on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.|The analysis dataset is comprised of treated patients.||proportion of participants||95% Confidence Interval|Number
127243|NCT00577382|Primary|2-month Progression-free Survival Rate|2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.|The analysis dataset is comprised of treated patients.||proportion of patients||95% Confidence Interval|Number
127244|NCT00577356|Primary|Number of Participants With Pathological Complete Response.|CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen|The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy.|Study was stopped before analysis occured.||participants|||Number
127245|NCT00577135|Secondary|Net Fluid Loss||Through 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mL||Standard Deviation|Mean
127246|NCT00577135|Secondary|Net Fluid Loss||Through 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mL||Standard Deviation|Mean
127247|NCT00577135|Secondary|Net Fluid Loss||Through 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mL||Standard Deviation|Mean
127266|NCT00577135|Secondary|Change in Cystatin C||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/L||Standard Deviation|Mean
127248|NCT00577135|Secondary|Treatment Failure|Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization|Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||percentage of participants|||Number
127249|NCT00577135|Secondary|Presence of Cardiorenal Syndrome||Within 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||percentage of participants|||Number
127250|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||pg/mL||Standard Deviation|Mean
127251|NCT00577135|Secondary|Change in NTproBNP||baseline and Day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||pg/mL||Standard Deviation|Mean
127252|NCT00577135|Secondary|Change in B-type Natriuretic Peptide|Change in NTproBNP|baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||pg/mL||Standard Deviation|Mean
127253|NCT00577135|Secondary|Change in Uric Acid||baseline and Day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127254|NCT00577135|Secondary|Change in Uric Acid||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127255|NCT00577135|Secondary|Change in Uric Acid||baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127256|NCT00577135|Secondary|Change in Cystatin C||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/L||Standard Deviation|Mean
127257|NCT00577135|Secondary|Change in Cystatin C||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/L||Standard Deviation|Mean
127258|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better|72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
127259|NCT00577135|Secondary|Dyspnea VAS|Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
127260|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-4800; higher score is better|48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
127261|NCT00577135|Secondary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
127262|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 60|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127263|NCT00577135|Secondary|Change in Serum Creatinine||baseline and day 7|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127264|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127265|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 48 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127554|NCT00574405|Primary|Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.||12 months|Per protocol||ng/mL||Standard Deviation|Mean
127267|NCT00577135|Secondary|Change in Serum Creatinine||baseline and 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127268|NCT00577135|Secondary|Dyspnea, as Determined by Visual Analog Scales|Global Visual Analog Scale Scale Range 0-2400; higher score is better|Measured at 24 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
127269|NCT00577135|Secondary|Proportion of Patients Free of Congestion||Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||percentage of participants|||Number
127270|NCT00577135|Secondary|Change in Weight||baseline and 96 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||lbs||Standard Deviation|Mean
127271|NCT00577135|Primary|Change in Serum Creatinine||Measured at baseline and 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||mg/dL||Standard Deviation|Mean
127272|NCT00577135|Primary|Patient Well Being, as Determined by a Visual Analog Scale|Global Visual Analog Scale Scale Range 0-7200; higher score is better|Measured at 72 hours|Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.||units on a scale||Standard Deviation|Mean
127273|NCT00577122|Secondary|MPA Trough Concentration|To explore genetic determinants of MPA bioavailability and trough concentration by showing average MPA levels at cycle 1 (Day 10-14) and cycle 2 (Day 1).|Cycle 1 (Day 10-14) and Cycle 2 (Day 1)|All patients with available data||ng/mL||Standard Deviation|Mean
127274|NCT00577122|Secondary|MPA Trough Level > 50 ng/mL When Have Clinical Benefit|To explore the relationship between MPA trough level and clinical benefit. This is done by seeing if the MPA concentrations remained > 50 ng/mL after initial dose escalation for those patients who showed clinical benefit. The number shows how many of the patients who showed clinical benefit had MPA concentrations > 50 ng/mL.|baseline through end of treatment|Patients who showed clinical benefit (CR, PR, or SD > 6 months)||participants|||Number
127275|NCT00577122|Secondary|Grade 3 or 4 Adverse Events Related to Treatment|To evaluate the toxicity of MPA and MPA + ldoCM in this patient population by the number of patients who have grade 3 or 4 adverse events that are related to treatment.|baseline through end of treatment|All patients in the study||participants|||Number
127276|NCT00577122|Primary|Clinical Benefit Rate (CR + PR + SD > 6 Months).|To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.|baseline through end of study, up to 3 years|All Patients on study.||Percent of Participants||95% Confidence Interval|Number
127277|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||g/dl||Standard Deviation|Mean
127278|NCT00577096|Secondary|Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)|Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||g/dl||Standard Deviation|Mean
127279|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Days||Standard Deviation|Mean
127280|NCT00577096|Primary|Total Number of Days of Stem Cell Collection (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Days||Standard Deviation|Mean
127281|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Stem Cell Collection Attempts||Standard Deviation|Mean
127282|NCT00577096|Primary|Number of Stem Cell Collection Attempts (Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Stem Cell Collection Attempts||Standard Deviation|Mean
127429|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 10 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127283|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)||up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Platelet Transfusions||Standard Deviation|Mean
127284|NCT00577096|Primary|Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)||up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||Platelet transfusions||Standard Deviation|Mean
127285|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 30 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||RBC Transfusions||Standard Deviation|Mean
127286|NCT00577096|Primary|Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)|The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.|up to 15 weeks|For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).||RBC Transfusions||Standard Deviation|Mean
127287|NCT00577083|Secondary|Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved.|During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.|after 2nd colonoscopy was completed in 24hrs||08/2017||||
127288|NCT00577083|Primary|Number of Adenomas|Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted.|after the second colonoscopy is completed|||First Colonoscopy number of adenomas|||Number
127289|NCT00577031|Secondary|European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score|"Quality of life (QoL) assessments were used to derive pre-specified QoL scores according to the QoL manual “EQ-5D-3 Level (3L) user guide for instrument version 4.0. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The visual analog scale (VAS) component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The overall health score absolute changes were calculated for each participant as follows: (score at the end of treatment minus score at baseline). EQ-5D health states were converted into EQ-5D-3L raw index value by applying the scoring algorithm based on the European EQ-net VAS set. The raw index was chosen instead of rescaled index, since the questionnaire was used in order to obtain a quality of life assessment. The raw index scores ranged from 0 (worst health state) to 100 (best health state)."|Baseline, every 9 weeks (every 3 cycles), at end-of-treatment up to 5 years|ITT population, only participants who had EQ-5D-3L scores for both baseline and last visit were included in the analysis.||units on a scale||Standard Deviation|Mean
127290|NCT00577031|Secondary|Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status|"The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.~The K-Ras and/or the B-Raf gene mutation status of participants was evaluated by the central laboratory using tumor samples. Wild-type participants did not have a mutation in either gene."|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population; only participants with a known K-Ras and/or B-Raf gene mutation status and at least 1 post-baseline tumor assessment. Number (n) equals (=) number of participants with either wild-type or K-Ras/B-Raf gene mutation.||percentage of participants|||Number
127291|NCT00577031|Secondary|Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery|The percentage of participants who underwent surgery during the study period with an evaluation of their disease status after surgery. The surgery during the study period was described by reason: curative, palliative, biopsy, other, or unknown. Residual disease status after surgery was described as: no residual disease due to radical surgery, presence of residual disease, unknown or not applicable.|At surgery, at least 6 to 8 weeks after last dose of bevacizumab up to 5 years|The 52 participant subpopulation of the ITT population who underwent surgery during the time period of the study.||percentage of participants|||Number
127640|NCT00573287|Secondary|Psychiatric Symptoms Measured Using the Brief Psychiatric Rating Scale, Clinical Global Inventory, and Schedule for the Assessment of Negative Symptoms at Baseline and Then at Weeks 4, 8, 12, 16, 20, and 24.||24 weeks||||||
127292|NCT00577031|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive. Median overall survival was estimated using the Kaplan-Meier method.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.||months||95% Confidence Interval|Median
127293|NCT00577031|Secondary|Overall Survival: Percentage of Participants That Died Due to Any Cause|Overall survival was defined as the time from the date of the first day of treatment until the date of death from any cause. If a participant was not known to have died, survival was censored at the last date the participant was known to be alive.|Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years|ITT population.||percentage of participants|||Number
127294|NCT00577031|Secondary|Time to Treatment Failure|Time to treatment-failure was defined as the time from the first day of treatment to discontinuation of treatment for any reason, including: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). For participants who did not experience a qualifying event, their data were censored at the earlier of either the date of last tumour assessment or the date of the last intake of study medication. Median time to treatment-failure was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.||months||95% Confidence Interval|Median
127295|NCT00577031|Secondary|Percentage of Participants With Treatment Failure|Treatment-failure was defined as discontinuation of treatment for any reason, including the following qualifying events: death due to any cause, adverse event, insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population.||percentage of participants|||Number
127296|NCT00577031|Secondary|Duration of Stable Response|For participants with a best overall response of CR, PR, or SD during first line treatment, the duration of stable response was measured from the time that the criteria for CR, PR, or SD (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of stable response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.||months||95% Confidence Interval|Median
127297|NCT00577031|Secondary|Percentage of Participants With a Stable Response During First Line Treatment|Stable response defined as participants with a best overall response of CR, PR, or stable disease (SD), defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only participants who achieved a best overall response of CR, PR, or SD during first line treatment were included in the analysis.||percentage of participants|||Number
127298|NCT00577031|Secondary|Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event|For participants with a best overall response of CR or PR, the duration of overall response was measured from the time that the criteria for CR or PR (whichever occurred first) was met until the first date that progressive disease was objectively documented or until the date of death due to underlying cancer, whichever occurred first. Data for participants who did not have an event or who were alive without an objectively documented progressive disease were censored at the date of last adequate tumor assessment. Median duration of overall response was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.||months||95% Confidence Interval|Median
127299|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment|CR and PR were defined using RECIST v1.0 criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years|ITT population, only those participants who achieved a best overall response of CR or PR during first line treatment were included in the analysis.||percentage of participants|||Number
127300|NCT00577031|Secondary|Time to CR or PR Overall Response - Time to Event|Time to overall response (CR or PR) was calculated as the time between the date of start of treatment until first documented response (CR or PR defined per RECIST v1.0). Participants who did not achieve CR or PR were censored at the date of progression, death, or at last adequate tumor assessment date. Median time to CR or PR overall response was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.||months||95% Confidence Interval|Median
127430|NCT00576420|Secondary|Percentage of Participants Achieving Hemostasis at 6 Minutes|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application start|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127301|NCT00577031|Primary|PFS: Time to Event|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented that neither a relapse nor a new colorectal cancer had occurred. Median PFS was estimated using the Kaplan-Meier method.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|ITT population.||months||95% Confidence Interval|Median
127302|NCT00577031|Secondary|Percentage of Participants With a CR or PR Among Participants in the ITT Population|CR and PR were defined using RECIST v1.0. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis <10 mm). No new lesions. PR was defined as a ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|ITT population.||percentage of participants|||Number
127303|NCT00577031|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment|The percentage of participants with a best overall response of CR or PR according to RECIST. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years|Subset of participants in the ITT population who had at least 1 post-baseline tumor assessment.||percentage of participants|||Number
127304|NCT00577031|Primary|Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death|PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Baseline and Day 1 of every cycle until disease progression or death up to 5 years|Intent-to-treat (ITT) population: all enrolled participants who received at least 1 dose of all study medications and had at least 1 measurable lesion according to the Response Evaluation Criteria In Solid Tumours (RECIST) criteria.||percentage of participants|||Number
127305|NCT00576927|Other Pre-specified|Daytime Sleep|As measured by percent of daytime behavioral observations observed asleep|All Assessment Phases, up to one week|||percentage of daytime sleep observations||Standard Deviation|Mean
127306|NCT00576927|Secondary|Daytime Engagement Status|Trained research technicians observed the subjects behavior during assessment phases every 15 minutes for one full minute. Specific behavioral definitions were employed to record whether the subject was in or out of bed, awake or asleep (eyes closed with no purposeful movement for at least 60 consecutive seconds), actively engaged in an activity (reading, watching television, conversation, a specific group activity, etc), and whether any physical or verbal agitation was noted.|All Assessment Phases, up to one week|||percentage of engaged observations||Standard Deviation|Mean
127307|NCT00576927|Primary|Number of Participants Meeting Good Sleep Latency Criteria|"Sleep Latency Criteria for Good Latency measured by behavioral observations conducted every 10-15 minutes after 4pm until 11pm.~Good latency is described as subject asleep in under 20 minutes on 51% of the nights observed in a week."|All assessment periods, up to one week|30 subjects enrolled into the behavioral intervention. 4 subjects responded to the sleep hygiene intervention (SHI) arm and completed the study. 3 subjects were excluded for various reasons from the SHI arm. 23 subjects continued onto the placebo/SHI. 1 subject withdrew from that arm. From there,11 subjects received drug and 11 remained on placebo||participants|||Number
127308|NCT00576927|Secondary|Sleep Efficiency|% of time asleep holding time in bed constant (averaged over 3-5 nights)|All Assessment Phases, up to one week|Per protocol -- intention to treat - ITT - last carried forward.||percentage of sleep||Standard Deviation|Mean
127309|NCT00576901|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles.|Following Cycle 6|ITT population.||percentage of participants|||Number
127310|NCT00576901|Secondary|Overall Survival|Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival is not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.|||||
127311|NCT00576901|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first.|Cycles 1-6|The application of a statistical model for the analysis of disease-free survival was not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.|||||
127312|NCT00576901|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Day 1 of Cycles 1-6|ER population||percentage of participants|||Number
127313|NCT00576901|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)|Evaluable Response (ER) Population: study-eligible participants who completed at least 2 treatment cycles; had lesions evaluated using the same technique at baseline and at least once after receiving the second treatment cycle; and had no major protocol deviation.||percentage of participants|||Number
127314|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes||52 weeks (efficacy and extension study phases)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received).||participants|||Number
127315|NCT00576823|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.~A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (efficacy study phase)|The analysis was performed on the ITT population (i.e. all included patients who received at least one dose of Alfuzosin).||participants|||Number
127316|NCT00576823|Primary|Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis|"Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point.~'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney.~'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney."|baseline and 12 weeks (efficacy study phase)|The analysis was on the intent-to-treat (ITT) population (i.e. all included patients who received at least one dose of Alfuzosin) excluding the patients who didn't have baseline SFU grade. Patients without post-baseline SFU grade before Week 12 were included as non-responders.||participants|||Number
127317|NCT00576758|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)|Blood was collected on Day 1 pre-infusion, during the safety follow-up for those patients who did not enter the Extension period and 6 months after the last infusion of the Extension Period if applicable. Blood was sent to a central laboratory and was tested for anti-obinutuzumab antibodies using a validated enzyme-linked immunosorbent assay (ELISA). HAHA samples were not collected for participants randomized to the rituximab arm.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received study drug.||Participants|||Number
127318|NCT00576758|Secondary|Number of Participants With Human Anti-Chimeric Antibodies (HACA)|Blood was collected on Day 1 and was sent to a central laboratory for analysis of human anti-chimeric antibodies (anti-rituximab antibodies) using a validated enzyme-linked immunosorbent assay (ELISA). HACA samples were not collected for participants randomized to the rituximab arm.|Day 1|Participants from the Safety Population, all randomized participants who received study drug, who had samples available for HACA analysis.||Participants|||Number
127319|NCT00576758|Secondary|Number of Participants With Infusion Related Reactions|Infusion Related Reactions were AEs that occurred during the infusion or within 24 hours of the infusion.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Safety Population included all randomized participants who received at least once dose of study drug.||Participants|||Number
127320|NCT00576758|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory result), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months) [Includes all AEs reported 28 days after last dose and all Related SAEs regardless of time of last dose.]|Safety Population included all randomized participants who received study drug.||Participants|||Number
127345|NCT00576732|Secondary|Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.|"Investigator impression of change over time from double-blind baseline on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse)."|6 weeks|All randomized subjects with at least one dose of study medication and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||participants|||Number
127488|NCT00575185|Primary|Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline|All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline|21 days|||participants|||Number
127321|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as the time point when the CD-19 values return to ≥ 50% of baseline levels. The number of participants with B-cell recovery from End of Induction (treatment) Phase to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) or Recovery without PD. PD required one of the following: 50 % increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50 % increase in the longest diameter of any previous site of lymphadenopathy, 50 % increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|End of last dose + 6 Months Follow-Up|Participants from the Safety Population, all randomized participants who received study drug, with previous B-Cell Depletion and B-Cell assessment at 6 Month Follow-up.||Participants|||Number
127322|NCT00576758|Secondary|Number of Participants With Peripheral Blood B-Cell Depletion|Blood was collected and sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry at the end of the induction period. B-cell depletion was defined as a CD19 result 5 % of the Baseline value after at least one dose of study drug was administered.|Day 22|Participants from the Safety Population, all randomized participants who received study drug, with data available for analysis.||Participants|||Number
127323|NCT00576758|Secondary|Obinutuzumab Trough Serum Concentration (Ctrough)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Ctrough was calculated in micrograms/milliliter (μg/mL).|Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||μg/mL||Standard Deviation|Mean
127324|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve Between Dosing Interval (AUCtau)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUCtau was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||day*μg/mL||Standard Deviation|Mean
127325|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Volume of Distribution at Steady-State (Vss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss was calculated in liters (L).|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||Liter||Standard Deviation|Mean
127326|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Clearance at Steady-State (CLss)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLsst was calculated in milliliter/day (mL/day)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||mL/day||Standard Deviation|Mean
127327|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Area Under the Concentration Curve (AUClast)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). AUClast was calculated in days* micrograms/milliliter (μg/mL)|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||day*μg/mL||Standard Deviation|Mean
127328|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for PK Parameters before and after dose administration of obinutuzumab in Induction Phase Cycles 1, 2, 3 and 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was calculated in micrograms/milliliter (μg/mL).|Day 1 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours post-infusion), Days 8 and 15 (pre-infusion, at end of infusion), Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||μg/mL||Standard Deviation|Mean
127329|NCT00576758|Secondary|Obinutuzumab Serum PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for Pharmacokinetic (PK) Parameters before and after dose administration of obinutuzumab in Induction Phase Cycle 4. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Terminal Half-Life was calculated in days.|Day 22 (pre-infusion, at end of infusion, 3-6, 20-28, 66-80 hours, 6-8, 12-16, 18-24, 28-56 days post-infusion)|PK Analysis Population included all participants who received obinutuzumab and had PK samples collected as per protocol. Patients with limited PK sampling time-points were excluded from the analysis.||days||Standard Deviation|Mean
127346|NCT00576732|Secondary|Change in Clinical Global Impression Severity (CGI-S)|"Investigator evaluation of severity of illness and functional impairment on a 7-point scale (1=not ill, 2=very mild, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe)."|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||units on a scale||Standard Deviation|Mean
127330|NCT00576758|Secondary|Duration of Response|"Duration of Response was defined as the date the response, either Complete Response (CR) or Partial Response (PR), was first recorded until the date of Disease Progression or death due to any cause. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.~Disease Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants with follicular NHL at the time of diagnosis N=75/74] with response. Patients with no documented progression after CR or PR will be censored at the last tumor assessment. If no assessment available patients will be censored at the first study drug.||Months||95% Confidence Interval|Median
127331|NCT00576758|Secondary|Percentage of Participants With Event Free Survival (EFS) Events|"Percentage of participants with Event Free Events: disease progression/relapse, death, or start of a new anti-leukemic therapy.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants|||Number
127332|NCT00576758|Secondary|Event Free Survival|"Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no EFS event occurred, EFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.||Days||95% Confidence Interval|Median
127333|NCT00576758|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Events|"The percentage of participants with progression, relapse, or death events from any cause as assessed by the Investigator.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the ITT population (all randomized participants) with follicular non-Hodgkin's lymphoma at the time of diagnosis. If event did not occur, PFS was censored at the date of the last tumor assessment. If no tumor assessment is available patient was censored at the date of the first study drug administration.||Percentage of participants|||Number
127334|NCT00576758|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the Investigator.~Progression was defined as a ≥ 50% increase from nadir in the SPD of any previously identified abnormal node and/or the appearance of any new lesion during or at the end of therapy.~Relapse was defined as the appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites and/or a ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|ITT population included all randomized participants with follicular non-Hodgkin's lymphoma at the time of diagnosis. If no PFS even occurred, PFS was censored at the date of the last tumor assessment. If no tumor assessment was available patient was censored at the date of the first study drug administration.||Days||95% Confidence Interval|Median
127335|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
127336|NCT00576758|Secondary|Number of Participants With Improved Overall Response During the Extended Treatment Period|Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.|Randomization to Clinical cutoff: 07 March 2013 (Up to 43.2 months)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis who received treatment in the extension period.||Participants|||Number
127489|NCT00575146|Secondary|Quality of Life||while on study treatment for up to 12 months||||||
127337|NCT00576758|Secondary|Percentage of Participants With Best Overall Response Achieved at Any Time During the Study Treatment|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigators during study treatment (induction or extended treatment phase). Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
127338|NCT00576758|Secondary|Percentage of Participants With Partial Response (PR) at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
127339|NCT00576758|Secondary|Percentage of Participants With Complete Response at the End of the Induction Period|Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. CR is defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL. All lymph nodes and nodal masses must have regressed to normal size. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination. Any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Other organs considered to be enlarged before therapy due to involvement by lymphoma, such as liver and kidneys, must have decreased in size. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site.|Randomization to clinical cutoff : 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants||95% Confidence Interval|Number
127340|NCT00576758|Primary|Percentage of Participants With Overall Response At the End of Induction Period|"Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigator at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson.~CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL.~CRu was CR plus one or more of the following: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameter (tumors)(SPD) and/or indeterminate bone marrow.~PR was defined as 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. No new sites of disease."|Randomization to clinical cutoff: 01 September 2011 (Up to 70 days)|Participants from the Intent-to-treat (ITT) population (all randomized participants) with follicular non-Hodgkin's lymphoma (NHL) at the time of diagnosis.||Percentage of participants|||Number
127341|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Months|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1) formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.||units on a scale||Standard Deviation|Mean
127342|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Months||Baseline and 6 months|All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.||mg/dL||Standard Deviation|Mean
127343|NCT00576732|Secondary|Change in Insulin Resistance (IR) at 6 Weeks|Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1)formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.|Baseline and 6 weeks|All randomized subjects with >=1 dose of study medication and fasting glucose and insulin at baseline and at >=1 postbaseline time point. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period. Means are adjusted for baseline weight (<45 kg, >=45 kg) and baseline IR.||units on a scale||95% Confidence Interval|Least Squares Mean
127344|NCT00576732|Secondary|Change in Fasting Glucose (mg/dL) at 6 Weeks||Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline fasting laboratory samples. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||mg/dL||Standard Deviation|Mean
127490|NCT00575146|Secondary|Ketosis||while on study treatment for up to 12 months||||||
127347|NCT00576732|Secondary|Number of Participants Who Had at Least 25% Improvement in ABC-I|ABC-I is a measure of irritability symptoms of autism with score range 0 to 45 (lower score = lesser severity).|6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||participants|||Number
127348|NCT00576732|Primary|Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale|Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).|Baseline and 6 weeks|All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).||units on a scale||Standard Deviation|Mean
127349|NCT00576693|Primary|Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment.|Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up.|Mean length of follow-up was 2.4 years|All patients enrolled in the study were included in the primary outcome analysis.||participants|||Number
127350|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A was reported during the EEP. EEP was from Week 29 to Week 36.|From Week 29 to Week 36 (EEP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||participants|||Number
127351|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Transferrin Saturation|The mean values for transferrin saturation (TSAT) for each individual participant were estimated throughout the study. Summary data of mean values of TSAT at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||percentage of saturation||Standard Deviation|Mean
127352|NCT00576628|Secondary|Mean Values of Laboratory Parameters: White Blood Cell and Thrombocyte Count|The mean values of white blood cell (WBC) and thrombocyte count for each individual participant were estimated throughout the study. Summary data of mean values of WBC and thrombocyte count at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||10^9 cells/liter||Standard Deviation|Mean
127353|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Ferritin Concentration|The mean values of ferritin concentration for each individual participant throughout the study were estimated. Summary data of mean values of ferritin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||micrograms per liter||Standard Deviation|Mean
127354|NCT00576628|Secondary|Mean Values of Laboratory Parameter: Albumin and Transferrin Concentration|The mean values of albumin and transferrin concentration for each individual participant throughout the study were estimated. Summary data of mean values of albumin and transferrin concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||grams per liter||Standard Deviation|Mean
127355|NCT00576628|Secondary|Mean Values of Laboratory Parameter: C Reactive Protein|The mean values of C reactive protein (CRP) for each individual participant throughout the study were estimated. Summary data of mean values of CRP at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.||milligrams per liter||Standard Deviation|Mean
127356|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Serum Creatinine|The mean values of serum creatinine for each individual participant throughout the study were estimated. Summary data of mean values of serum creatinine at Week 0 (Baseline) and Week 32 are presented.|Baseline (Week 0), and Week 32|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||micromoles/liter||Standard Deviation|Mean
127368|NCT00576576|Secondary|Change in Atheroma Volume|Change in atheroma volume between baseline and follow-up is reported. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set||mm^3||Inter-Quartile Range|Median
127491|NCT00575146|Secondary|Frequency of Seizures||while on study treatment for up to 12 months||||||
127357|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Iron and Total Iron Binding Capacity|The mean values of iron and total iron binding capacity (TIBC) for each individual participant were estimated throughout the study. Summary data of mean values of iron and TIBC at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||micromoles/liter||Standard Deviation|Mean
127358|NCT00576628|Secondary|Mean Values of Laboratory Parameters: Potassium and Phosphate Concentration|The mean values of potassium and phosphate levels in serum for each individual participant were estimated throughout the study. Summary data of mean values of potassium and phosphate level in serum at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|"The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The n represents the number of participants analyzed at a specified time point."||millimoles per litre||Standard Deviation|Mean
127359|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. The mean values of hematocrit for each individual participant were estimated throughout the study. Summary data of mean values of hematocrit at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.||fraction||Standard Deviation|Mean
127360|NCT00576628|Secondary|Mean Values of Laboratory Parameter : Hb Concentration|The mean Hb concentration for each individual participant throughout the study was estimated. Summary data of mean values of Hb concentration at Week 0 (Baseline), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48 are presented.|Baseline (Week 0), Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not. The “n” represents the number of participants analyzed at a specified time point.||g/dL||Standard Deviation|Mean
127361|NCT00576628|Secondary|Number of Participants With Red Blood Cells Transfusions.|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported.|Up to Week 52|The analysis was performed on safety population. The safety population included all the participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.||participants|||Number
127362|NCT00576628|Secondary|Time to Achievement of Response During the Efficacy Evaluation Period|The time to achievement of response was defined as the time when the participants achieved Hb concentration within the target range of 11.0 to 13.0 g/dL during the EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||days||Standard Deviation|Mean
127363|NCT00576628|Secondary|The Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A was reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|From Week 0 to Week 28 (DTP)|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||participants|||Number
127364|NCT00576628|Secondary|Mean Time Spent in Target Hb Range of 11.0 -13.0 g/dL During the Efficacy Evaluation Period|The number of days spent by participants with Hb in range of 11.30 -13.0 g/dL was calculated during the EEP and presented. The EEP comprised was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||days||Standard Deviation|Mean
127365|NCT00576628|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within the Target Range of 11.0-13.0 g/dL Throughout the EEP|Percentage of participants maintaining individual Hb concentration within the range of 11.0-13.0 g/dL was reported during EEP. The EEP was from Week 29 to Week 36.|From Week 29 to Week 36|The primary analysis was performed on PP population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||percentage of participants||95% Confidence Interval|Number
127366|NCT00576628|Primary|Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period|The mean change in Hb concentration between Baseline and Efficacy Evaluation Period (EEP) was calculated by subtracting the baseline Hb concentration from the EEP Hb concentration. Each participant included in this analysis had at least 3 recorded Hb values during EEP, and these Hb values were combined using a time-adjusted average. The EEP was from Week 29 to Week 36.|Baseline (Week 0) and from Week 29 to Week 36|The primary analysis was performed on per protocol (PP) population. The PP population included all treated participants (ITT participants) except those who had less than 3 recorded Hb values during EEP or with inadequate iron status during the EEP or missed administrations of C.E.R.A. during Week 28 to Week 36.||g/dL||Standard Deviation|Mean
127367|NCT00576576|Secondary|Change in Fibrous Plaque Volume|Change in fibrous plaque volume between baseline and follow-up. This was derived by subtracting the baseline value from the 6-month value.|6 months|All enrolled patients with complete data set||mm^3||Inter-Quartile Range|Median
127369|NCT00576576|Primary|Change in Necrotic Core Volume|Virtual Histology-Intravascular Ultrasound (VH-IVUS) defined necrotic core cross sectional area (CSA) measured in each VH-IVUS frame and averaged over length of studied vessel at baseline and follow -up. Change in necrotic core CSA between baseline and follow-up was calculated (subtracting the baseline value from the follow-up value).|6 months|All enrolled patients with complete data set||mm^2||Standard Deviation|Mean
127370|NCT00576524|Secondary|Changes in Heart Rate and Blood Pressure Measured by a Non-invasive Cuff.||6 weeks|Data not analyzed - study closed due to lack of recruitment|||||
127371|NCT00576524|Secondary|Extra Days to Achieve Target Dry Weight|Extra number of days required for hemodialysis/ultrafiltration to achieve dry body weight|6 weeks|Data not analyzed - study closed due to lack of recruitment|||||
127372|NCT00576524|Primary|Fluid Removal|Fluid removed as percentage of dry body weight.|6 weeks|Data not analyzed - study closed due to lack of recruitment|||||
127373|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Interference Score have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
127374|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Ink Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
127375|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Color Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
127376|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the Stroop Word-Color Association Test (Stroop) to estimate the effectiveness of MPH on laboratory measures of interference, impulsivity, cognitive flexibility, and selective attention. Stroop T scores for Word Naming Time have a mean of 50 and a standard deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
127377|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Long Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated Z Score||Standard Error|Mean
127378|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Z Score for Short Delay Free Recall has a mean of 0 and a standard deviation of 1.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated Z Score||Standard Error|Mean
127422|NCT00576420|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline – Intraoperative Day 0; Preoperative Baseline – Postoperative Day 1; and Preoperative Baseline – Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set||percent change||Full Range|Median
127423|NCT00576420|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||mm Hg||Full Range|Median
127379|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials.|Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We are interested in testing the difference of effects of MPH and placebo, not in testing the difference of two sequence groups. We will use the California Verbal Learning Test (CVLT) to estimate the effectiveness of MPH on laboratory measures of learning and recall. CVLT Trials 1-5 have a mean T Score of 50 and Standard Deviation of 10.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated T Score||Standard Error|Mean
127380|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Beta (Risk Taking).|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D′ and β are derived variables from signal detection theory. β is a measure of response tendency; higher scores indicate a more conservative response pattern. β was calculated using the formula = –d′*.5*(NORMSINV(hits)-NORMSINV(false alarms)). In the case where the false alarm rate = 0 or the hit rate = 1.0, we used the standard correction of 1/2N and 1- 1/2N, respectively.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
127381|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d’ (Sensitivity).|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. D′ and β are derived variables from signal detection theory. D′ is a measure of sensitivity of a person to the signal or target; a higher score is indicative of better performance or better sustained attention. D′ was calculated as z(hit) – z(commission). Z-scores were calculated using the NORMSINV function in Microsoft Excel.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
127382|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Hit Reaction Time.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Hit reaction time is average reaction time in milliseconds for all correct responses when targets were presented. There is no pre-defined range for reaction time; higher score is indicative of slower processing speed.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
127383|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Commission errors are the raw score for the numbers of nontargets presented where the subject incorrectly responded. Accordingly, the range for this variable is 0-6 with a higher score indicative of worse performance or impulsivity.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
127384|NCT00576472|Secondary|Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Omission Errors.|Change in raw scores for the shortened version of the Conner’s CPT from Baseline to Post-dose. The continuous performance test used during the in-lab trial was developed in house using SuperLab Pro v2.0 (Cedrus Corp., Phoenix, AZ). The test was modeled after Conners' CPT, but was shortened for ease of administration and evaluation of short-form sensitivity. The test is one-sixth the length of the Conners’ CPT, lasting 2.33 min with 54 total targets and six nontargets (10% of trials). Similar to the Conners’ CPT, the interstimulus intervals also varied by trial blocks with lengths of 1, 2, or 4 s. Omission errors are the raw score for the number of targets presented where the subject did not respond. Accordingly, the range for this variable is 0-54 with a higher score indicative of worse performance or problems with sustained attention.|Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo.|A mixed model was used to estimate the means of MPH and Placebo accounting for carry-over effects in the In-Lab crossover phase.||Estimated raw score||Standard Error|Mean
127385|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
127386|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
127387|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Problem Behavior.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
127388|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Social Skill.|The SSRS assesses social skills for children and adolescents at preschool, elementary and secondary developmental levels. The SSRS is 40 to 57 items, depending on age, completed separately by parents (SSRS-P) and teachers (SSRS-T). Respondents rate the frequency of occurrence for each item ranging from 0 to 2 (0-never, 1-sometimes, 2-very often). The raw scores for the SSRS-P and SSRS-T Social Skills Scales and the SSRS-P and SSRS-T Problem Behaviors Scales have different ranges that are dependent upon age. Raw scores obtained from the SSRS Scales cannot be used to directly interpret social skills or problem behaviors as raw scores vary in meaning based on scale, informant form and developmental level. Raw scores are converted to standard scores with a mean of 100 ± 15. For the Social Skills Scale, a higher score is indicative of better social functioning, and for the Problem Behaviors Scale, a higher score is indicative of greater behavior problems.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated Standard Score||Standard Error|Mean
127389|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) ADHD Index.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
127424|NCT00576420|Secondary|Percentage of Participants With Infections at the Surgical Site||Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set||percentage of participants||90% Confidence Interval|Number
127425|NCT00576420|Secondary|Percentage of Participants With Graft Occlusions|Determined clinically and defined as absence of blood flow through the graft.|Day 0 (procedure day) through day 30 ± 5|Safety Analysis Set||percentage of participants||90% Confidence Interval|Number
127390|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Hyperactivity Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
127391|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale.|The Conners' Teacher Rating Scale-Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
127392|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) ADHD Index.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
127393|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Hyperactivity Scale.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
127394|NCT00576472|Secondary|Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale.|The Conners’ Parent Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Three scales are reported: Cognitive Problems/Inattention (assesses the ability to learn at the same pace as peers, organize and complete work, and concentrate for sustained periods of time), Hyperactivity (assesses the ability to sit still to complete tasks, and impulsivity) and ADHD Index (assesses risk for ADHD disorder to be corroborated by other clinical information). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks.|122 children began the Home Crossover Trial. 121 received all the placebo, 119 received all of the low dose, and 109 received all of the moderate dose.||Estimated T Score||Standard Error|Mean
127395|NCT00576472|Secondary|Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase.|The Conners' Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were done weekly during the 3-week Home Crossover Period with the best response being used as the measurement for the test.|weekly during 3-week home crossover phase|There were 122 patients treated in the home crossover period. Some patients had missing treatments and outcome assessments. A crossover design was used for better efficiency of test and better precision of estimation.||T score||95% Confidence Interval|Mean
127492|NCT00575146|Secondary|Overall Survival|Participants were followed until reported death or last contact until 05/2011|death/last contact, an average of about 1 year|||weeks||Full Range|Median
127396|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Math Composite score assesses the child’s ability to solve calculation problems (Numerical Operations) and solve applied, word problems (Math Reasoning). Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score System. 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
127397|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Spelling score assesses the child’s ability to spell words to dictation. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and after completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score System and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
127398|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score|The Wechsler Individual Achievement Test is an examiner administered measure of academic skills. The Reading Composite consists of Basic Reading (single word reading) and Reading Comprehension. Raw scores are converted to standard scores with a mean of 100±15 where higher scores indicate better performance. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Wechsler Individual Achievement Test (WIAT) REading: Composite Standard Score questionnaire and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
127399|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P)|The Social Skills Rating System- Parent Version (SSRS-P) is a parent rating scale of social behaviors in reference to typically developing children. Thirty eight questions are rated 0 (Never) to 3 (very often). The social skills score is norm-referenced with a mean of 100±15 where a higher score is indicative of better skills. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System (SSRS-P) and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
127400|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Score Questionnaire and 68 were screened at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
127401|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-seven questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Score Questionnaire and 68 were screen at completion. 68 patients were analyzed.||T-score||95% Confidence Interval|Mean
127402|NCT00576472|Primary|Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Home Therapy Phase (baseline) and upon completion of the phase. Phase completion ranged between 11.44 to 24.36 months|From beginning and at completion of home maintenance phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screened at completion. 47 patients were analyzed.||T-score||95% Confidence Interval|Mean
127493|NCT00575146|Secondary|Progression-free-survival|measured by Macdonald-Criteria|until progression for up to 12 months|for the analyis of PFS and OS, 3 patients who discontinued the diet in the absence of progression were excluded||weeks||Full Range|Median
127403|NCT00576472|Primary|Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score)|The Conners’ Teacher Rating Scale- Revised (S) is a measure of the observed frequency of behaviors associated with ADHD. Twenty-eight questions are rated on a scale from 0 (not true at all) to 3 (very much true). Raw scores are converted to T scores using age and gender normative data. T scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. Assessments were performed prior to beginning the Methylphenidate (MPH) Home Maintenance Phase(baseline) and upon completion of the phase. Phase completion ranged between 11.44 and 24.36 months.|From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months.|118 patients began the MPH Home Maintenance Phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Score Questionnaire and 59 were screen at completion. 47 patients were analyzed.||T-score||95% Confidence Interval|Mean
127404|NCT00576472|Primary|Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls|To compare the white matter volume of patients by treatment intensity groups (mild, moderate, and high) and sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had an evaluable MRI image.||percentage||95% Confidence Interval|Mean
127405|NCT00576472|Primary|Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors|To compare the white matter volume of Acute Lymphoblastic Leukemia (ALL) patients with those of patients with malignant brain tumors using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images.||percentage||95% Confidence Interval|Mean
127406|NCT00576472|Primary|Brain White Matter Volume for Patients Versus Sibling Controls|To compare the white matter volume of patients with those of sibling controls using MRI results captured between -1.8 and 42.36 months from study enrollment. Existing MRIs very close to enrollment were permissable for inclusion in this study.|Enrollment to evaluation of MRI, on average 12.8 months.|Of the 505 patients enrolled, 106 did not have MRI acquired to measure brain volume, 16 were not evaluable: 6 had metal artifacts, 3 had motion artifacts, 1 had an acquisition error in MRI image, 4 had tumor on exam, and 2 had ischemic insults. 383 patients had evaluable MRI images. 67 of the 91 sibling controls had evaluable MRI images.||percentage||95% Confidence Interval|Mean
127407|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127408|NCT00576420|Secondary|Laboratory Values Over Time: International Normalized Ratio (INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||ratio||Full Range|Median
127409|NCT00576420|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||seconds||Full Range|Median
127410|NCT00576420|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||U/L||Full Range|Median
127411|NCT00576420|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||U/L||Full Range|Median
127412|NCT00576420|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Set||mg/dL||Full Range|Median
127413|NCT00576420|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Set||x10^3/µl||Full Range|Median
127414|NCT00576420|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set||x10^3/µl||Full Range|Median
127415|NCT00576420|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Set||x10^6/µl||Full Range|Median
127416|NCT00576420|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Set||percentage of red blood cells in blood||Full Range|Median
127417|NCT00576420|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Set||g/dl||Full Range|Median
127418|NCT00576420|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set||percent change||Full Range|Median
127419|NCT00576420|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||Breaths/ minute||Full Range|Median
127420|NCT00576420|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Preoperative baseline through postoperative Day 14|Safety Analysis Set||percent change||Full Range|Median
127421|NCT00576420|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set||Heart beats/ minute||Full Range|Median
127426|NCT00576420|Secondary|Percentage of Participants With Any Transfusion Requirement|Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)|Intraoperative (day 0) through day 30 ± 5|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127431|NCT00576420|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Moderate bleeding defined as:~Either >25% of the suture line bleeds, or~≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or~1 pulsatile suture line bleeding was present.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127432|NCT00576420|Primary|90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line|"Hemostasis at the study suture line must be maintained until closure of the surgical wound.~Participants were considered treatment failures if they met any of the following conditions:~Did not achieve hemostasis at 4 minutes~Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period~Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat||percentage of participants||90% Confidence Interval|Number
127433|NCT00576420|Primary|Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.|"Hemostasis at the study suture line must be maintained.~Participants were considered treatment failures if they met any of the following conditions:~Did not achieve hemostasis at 4 minutes~Required additional hemostatic treatment during the first 4 minutes of the observation period~Experienced rebleeding after the first 4 minutes of the observation period."|4 minutes post start of treatment application|Intent to Treat||percentage of participants|||Number
127434|NCT00576381|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs)|Based on an estimated inter-subject variability of 50% for clearance, a sample size of 32 evaluable subjects will be sufficient to detect an 18% difference (alpha 0.05, power 0.9) in the clearance in this population (38 + 18 L/hr) versus that previously reported in the adult population (46 L/hr).||mL/min||Standard Error|Least Squares Mean
127435|NCT00576316|Secondary|Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants||scores on a scale||Standard Deviation|Mean
127436|NCT00576316|Primary|Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART|Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction|6 months after each patient was initially treated with Symbicort SMART|201 participants were recruited but statistical analysis was completed for 195 participants||Scores on a scale||Standard Deviation|Mean
127437|NCT00576303|Secondary|Number of Participants With Red Blood Cell Transfusion|The number of participants who underwent red blood cell transfusion was reported|Up to 3 years|The safety population was defined as all participants who received at least one dose of the trial medication and underwent a safety follow-up, whether withdrawn prematurely or not.||number of participants|||Number
127438|NCT00576303|Secondary|Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP|The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44|DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. . Data for the participants present at the time of assessment was used for analysis i.e. for DTP- 199, EEP-183, LTSP-178 respectively.||number of participants|||Number
127439|NCT00576303|Secondary|Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP|The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available. Of the 199 participants, analysis was conducted on 184 participants, as 15 participants did not maintain their hemoglobin, within range of 10.5-12.5 g/dL during the EEP.||number of days||Standard Deviation|Mean
127440|NCT00576303|Secondary|Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP|All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|The ITT population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.||percentage of participants||95% Confidence Interval|Number
127460|NCT00575666|Primary|Psychopathology- PANSS General Psychopathology|General psychopathology was measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 16 items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 16, Max score= 112. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
127441|NCT00576303|Secondary|Mean Change in Hb Concentration From Baseline to the EEP|A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24|Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)|The Intent-to-Treat (ITT) population included all the participants who received at least one dose of C.E.R.A. and for whom data for at least one follow-up variable is available.||g/dL||Standard Deviation|Mean
127442|NCT00576303|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24|EEP (Week 16 to Week 24)|Per protocol (PP) population included participants except who didn’t meet inclusion criterion relative to consent, stable baseline Hb values, iron status, epoetin maintenance, and who met exclusion criterion of hemoglobinopathies/hemolysis, bleeding, >3 recorded Hb, missing drug administration, other ESA, blood transfusion during the DTP or EEP.||percentage of participants||95% Confidence Interval|Number
127443|NCT00576251|Primary|Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)|Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.|Day 4 - Test Of Cure (TOC) compared to Day 0|||Percent of patients|||Number
127444|NCT00576199|Secondary|Tumor Necrosis|Tumor necrosis was quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area was measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation in tumor after TACE was regarded as an indication of necrosis. Tumor necrosis was assessed at Baseline and 1 week prior to the next scheduled transarterial chemoembolisation (TACE) for the first 4 TACEs, then 1 week prior to every second TACE till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Percentage of tumor volume at Baseline||Standard Deviation|Mean
127445|NCT00576199|Secondary|Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease|A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the Baseline sum LD. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the LD) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the LD for all target lesions will be calculated and reported as the Baseline sum LD.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Percentage of participants||95% Confidence Interval|Number
127446|NCT00576199|Secondary|Overall Survival|Overall survival was defined as the time from the first administration of study drug to death.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Months||95% Confidence Interval|Median
127447|NCT00576199|Secondary|Time to Progression|Time to progression was defined as the time from the first administration of study drug to the first documented disease progression. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Months||95% Confidence Interval|Median
127448|NCT00576199|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response. A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Percentage of participants||95% Confidence Interval|Number
127486|NCT00575367|Primary|Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.||15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours|Per Protocol Population||µg/mL||Standard Deviation|Mean
127449|NCT00576199|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|Baseline to the end of the study (up to 3 years, 3 months)|Intent-to-treat population: All participants who received study medication.||Months||95% Confidence Interval|Median
127450|NCT00576147|Secondary|To Determine the Reproducibility of the Near-Infrared Spectroscopy (NIRS) Measurements With Different Operators and at Different Centers||2 years||||||
127451|NCT00576147|Primary|1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma.|"We will report Sensitivity and Specificity of NIRS device as compared to CT scanner to detect hematomas of more than 3.5 mL in volume and less than 2.5 cm from the surface of the brain.~Sensitivity is the ratio between true positives to all positive measurements. Specificity is the ratio between true negatives to all negative measurements."|2 years|431 Total patients enrolled; 365 total patients evaluated after 66 excluded for protocol violations; 269 Number of patients with no Intracranial Hemorrhage; 96 Number of patients with confirmed intrcranial hemorrhage; 50 Number of patients with Intracranial hemorrhage within detection limits of the device.||Number of participants|||Number
127452|NCT00576056|Secondary|Determine the Overall Survival in Patients Treated With This Combination Regimen|Overall survival (OS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of death. For a surviving patient, OS is censored by the last follow-up date when that patient is documented to be alive.|From date of initial treatment until the date of death from any cause|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).||days||Full Range|Median
127453|NCT00576056|Primary|Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality|Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Up to 24 months (from initial treatment through 12 months follow-up)|Patients who received at least one cycle of the entire treatment regimen (this did not include two patients who went on to receive liver transplants).||days||Full Range|Median
127454|NCT00575965|Primary|Progression-Free Survival|Progression-free survival is the defined as the time from study entry to disease progression (PD) or death based on Kaplan-Meier estimates. Patients alibe without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s). [Consensus panel criteria: Weber et al, 2003; Kimby et al, 2005].|Assessed at month 1 and 3 and thereafter every 3 months while on therapy; Assessed every 6 months for up to 2 years of follow-up. Median follow-up in this study cohort was 6 months (range 2-18 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.||months||95% Confidence Interval|Median
127455|NCT00575965|Primary|Objective Response Rate|Objective response is defined as achieving partial response or better on therapy based on the Consensus Panel Recommendations from the 2nd and 3rd International Workshop on WM [Weber et al, 2003; Kimby et al, 2005]. Complete Response (CR): Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. Partial Response (PR): a >=50% reduction from baseline in the SM IgM concentration. Minor Response (MR): >=25%, but a <50% reduction of SM IgM from baseline.|Assessed at month 1 and 3 and thereafter every 3 months while on therapy. Median duration on treatment was 6 months (range 1-24 months).|The analysis dataset is comprised of all evaluable patients. One patient was lost to follow-up within 3 weeks of enrollment and was unevaluable.||proportion of patients|||Number
127456|NCT00575887|Primary|Progression-free Survival at 6-months||Until progression|||percentage of participants|||Number
127457|NCT00575666|Primary|Psychopathology- QLS Total|Quality of life was measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 21 items, with each item measured on a seven-point scale (0= not present, 3= sometimes present, 6= always present). Min score= 0, Max score= 126. Higher scores represent lower quality of life. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
127458|NCT00575666|Primary|Psychopathology- CDSS Total|Symptoms of depression were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 9 items, with each item measured on a four-point scale (0= absent, 3= severe). Min score= 0, Max score= 27. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
127459|NCT00575666|Primary|Psychopathology- SANS Total|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of 25 items, with each item measured on a six-point scale (0= none, 3= moderate, 5= severe). Min score= 0, Max score= 125. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
127461|NCT00575666|Primary|Psychopathology- PANSS Negative|Negative symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. Assessment consisted of seven-items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
127462|NCT00575666|Primary|Psychopathology- PANSS Positive|Positive symptoms of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of seven items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 7, Max score= 49. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
127463|NCT00575666|Primary|Psychopathology- PANSS Total|Positive symptoms, negative symptoms, and general psychopatholgy of schizophrenia were measured at Screening/Baseline, Week 4, and Week 8. The assessment consisted of 30 total items, with each item measured on a seven-point scale (1= absent, 4= moderate, 7= extreme). Min score= 30, Max score= 210. Higher scores represent more advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on psychopathology measures; study completion allows for calculation of change scores.||units on a scale||Standard Deviation|Mean
127464|NCT00575666|Primary|Cognitive Function- CPT False-alarm Rate (Proportion)|Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). False alarm rate is defined as the proportion of overall hits that were in response to an incorrect stimulus (two consecutive non-identical targets). Assessments were completed at Screening/Baseline, Week 4, and Week 8. False-alarm hits were measured as a proportion of total hits. Min score= 0, Max score= 1.0. Lower values represent higher hit accuracy and less advanced psychopathology. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Proportion of total hits||Standard Deviation|Mean
127465|NCT00575666|Primary|Cognitive Function- CPT Reaction Time of Hits (Milliseconds)|"Subjects completed a computer-based cognitive functioning test designed to measure sustained attention (attention to a stimulus over a period of several minutes). The test is described in detail in a previous outcome measure (CPT d prime score). Reaction time of hits is defined as the average time each participant took to respond correctly to relevant stimuli. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Reaction time was measured in milliseconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Milliseconds||Standard Deviation|Mean
127466|NCT00575666|Primary|Cognitive Function- CPT Hits Rate (Proportion)|"Subjects completed a computer-based cognitive test. The test is described in detail in a previous outcome measure (CPT d prime score). Hits rate was defined as the proportion of correct responses to the relevant stimuli (response to two identical targets) compared to total responses (total hits). Assessments were completed at Screening/Baseline, Week 4, and Week 8. Hits rate as a proportion of total hits was measured. Min score= 0, Max score= 1.0. Higher values represent higher stimulus recognition accuracy, and thus less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Proportion of total hits||Standard Deviation|Mean
127467|NCT00575666|Primary|Cognitive Function- CPT D Prime Score|"Subjects completed a computer-based cognitive test designed to measure sustained attention (attention to a specific stimulus over a period of several minutes) before and after intranasal treatment. During this test, participants respond as quickly as possible to any consecutive presentation of identical stimuli on the computer screen. The stimuli (2, 3, and 4-digit targets) were presented with increasing cognitive load in successive blocks. Correct responses, responses made to the second of 2 identical stimuli presented in a row, were scored as hits. False alarms were also recorded. The d prime score is a score given to each participant on a scale of 0.0- 1.0 in which discrimination sensitivity is measured. A score of zero equates to no sensitivity, whereas a score of 1.0 equates to perfect sensitivity. Values below represent postreatment performance minus pretreatment performance. Higher scores represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||D prime score||Standard Deviation|Mean
127468|NCT00575666|Primary|Cognitive Function- Trails B|"Subjects completed a timed trails (i.e. connect the dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were mesured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Seconds||Standard Deviation|Mean
127469|NCT00575666|Primary|Cognitive Function- Trails A|"Subjects completed a timed trails (i.e. connect-the-dots) test. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Scores were measured by time to complete in seconds. Max score= N/A. Lower values represent less advanced psychopathology. Week 8 values are displayed below."|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Seconds||Standard Deviation|Mean
127470|NCT00575666|Primary|Cognitive Function- HVLT Delayed Recall Total|Subjects completed a delayed word recall task. Assessments were completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 12. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Words correct||Standard Deviation|Mean
127487|NCT00575185|Secondary|Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability|Assessing adverse events in participants to see if this drug causes more or less side effects|15 days|||participants|||Number
127471|NCT00575666|Primary|Cognitive Function- HVLT Immediate Recall Total|Subjects completed a word recall task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 36. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Words correct||Standard Deviation|Mean
127472|NCT00575666|Primary|Cognitive Function- Verbal Fluency|Subjects completed a verbal fluency test. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher levels of verbal fluency, and therefore less advanced psychopathology. Min score= 0, Max score= N/A. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Words correct||Standard Deviation|Mean
127473|NCT00575666|Primary|Cognitive Function- Digit Span Total|Subjects completed the digit span task. Assessment was completed at Screening/Baseline, Week 4, and Week 8. Higher scores represent higher recall accuracy, and therefore less advanced psychopathology. Min score= 0, Max score= 30. Week 8 values are displayed below.|Week 8|All subjects who completed the study for each Arm/Group were analyzed on cognitive function measures; study completion allows for calculation of change scores.||Items correct||Standard Deviation|Mean
127474|NCT00575588|Other Pre-specified|Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c|Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 104|||Percent||Standard Error|Mean
127475|NCT00575588|Other Pre-specified|Body Weight Change From Baseline to Week 104|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin||kilograms||Standard Error|Mean
127476|NCT00575588|Other Pre-specified|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)|Baseline, Week 104|||Percentage of Participants|||Number
127477|NCT00575588|Other Pre-specified|Hemoglobin A1c (HbA1c) Change From Baseline to Week 104|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.|Baseline, Week 104|Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin||Percent||Standard Error|Mean
127478|NCT00575588|Secondary|Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c|Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.|Week 24 to Week 52|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations||Percent||Standard Error|Mean
127479|NCT00575588|Secondary|Body Weight Change From Baseline to Week 52|Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.|Baseline, Week 52 (Last Observation Carried Forward)|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement||kilogram||Standard Error|Mean
127480|NCT00575588|Secondary|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks|Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)|From Baseline to Week 52|||Percentage of Participants|||Number
127481|NCT00575588|Primary|Hemoglobin A1c (HbA1c) Change From Baseline to Week 52|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.|Baseline to 52 Weeks|Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations||Percent||Standard Error|Mean
127482|NCT00575510|Secondary|State Trait Anxiety Inventory (STAI)-State Scale|State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)|+ 7-30 days post-intervention|Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.||units on a scale, possible range 6-24||Standard Deviation|Mean
127483|NCT00575510|Primary|Adherence to Initial Follow-up (Yes/no)|Attendance at initial appointment to follow-up abnormal Pap test result|adherence rates at initial follow-up appointment, 2 weeks to 3 months|||percentage of patients who were adherent|||Number
127484|NCT00575380|Secondary|Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)||Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312|||ug/mL||Standard Deviation|Mean
127485|NCT00575380|Primary|Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population)|Nominal time is scheduled time relative to administration of the first eye drop|Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312|||ug/g||Standard Deviation|Mean
128793|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
127495|NCT00575094|Primary|Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.|Clinical response: Cure=all initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR)improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for nonstudy drug/infection reasons (eg, lost to follow-up); death ≤2 days after first dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|8 weeks|All patients who received at least one dose of study drug.||participants|||Number
127496|NCT00575042|Secondary|Quality of Life According to NIDDK Questionnaire||1 year||||||
127497|NCT00575042|Primary|Serum Level of Alkaline Phosphatase|We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.|1 year|||U/L||Full Range|Median
127498|NCT00575029|Primary|Time Required for Recovery From Adrenal Suppression to Normal Adrenal Function|the number of weeks required for participants to recover from adrenal suppression as assessed by a normal ACTH stimulation test (cortisol level >21 mcg/dl)|weekly for up to 6 weeks|||weeks|||Number
127499|NCT00575029|Primary|Number of Participants With Adrenal Insufficiency|Number of participants with adrenal insufficiency after treatment with megestrol acetate assessed by ACTH stimulated cortisol levels less than normal (21 ug/dl) measured weekly for 8 weeks or when adrenal insufficiency is clinically encountered|stimulated acth stimulated cortisol levels weekly for 8 weeks or until adrenal insufficiency is encountered|||participants|||Number
127500|NCT00575016|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment||Centimeters of water (cm H2O)||Standard Deviation|Mean
127501|NCT00575016|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment||Milliliters (mL) of urine||Standard Deviation|Mean
127502|NCT00575016|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment||Number of Weekly Episodes||Standard Deviation|Mean
127503|NCT00574990|Secondary|Overall Involvement in Conversation by Roles|The number of communication events was recorded on electronic notepads during each observation period. The communication events recorded included: a) physicians to physicians, to nurses, to pharmacists, and to patients; b) nurses to nurses, to physicians, to pharmacists, and to patients; and c) pharmacists to pharmacists, to physicians, to nurses, and to patients. The percentage of each of these types of verbal communications was calculated from the total number of communication events.|6 months|||percentage of role involvement in event|||Number
127504|NCT00574990|Primary|Incident Rate for Communication Events|Observation periods were approximately two-hours long. Some providers were observed more than once. The number of communication events were counted per each observation period.|6 months|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.||mean events per observation||Standard Deviation|Mean
127505|NCT00574912|Primary|Glucose Infusion Rate|measuring the changes in glucose infusion rate during the 24 hour experimental period.|24 hours|12 participants in each arm||umol/kg/min||Standard Error|Mean
127506|NCT00574873|Secondary|Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks|"The cumulative incidence curve was generated based on the time from randomization to the first date of transformation to AP or BP while on study treatment adjusting for the competing risk of treatment discontinuation without transformation, for each participant.~Criteria for transformation to AP: 15 to 29% blasts; ≥30% blasts + promyelocytes; ≥20% basophils in blood or bone marrow; platelets <100*10^9/L (not related to therapy), in blood. Criteria for transformation to BP: ≥30% blasts in blood or bone marrow and extramedullary involvement other than liver or spleen (example: chloromas).~Time to transformation was calculated as weeks = ([date of first documented occurrence of the event - date of randomization] + 1)/7. If transformation was not obtained, censoring was at the last hematologic assessment or death (whichever was earliest). Participants who were not treated contributed time = 1 day/7. 95% confidence interval for the cumulative incidence is from Gray’s method."|192 weeks|ITT population||Percentage of Participants||95% Confidence Interval|Number
127507|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks|"The Kaplan-Meier curve was generated based on the first date of MMR until the first date loss of MMR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid molecular assessment.~Molecular response was assessed using Bcr-Abl transcript levels measured by RT-PCR from peripheral blood. MMR is defined as a ratio Bcr-Abl/Abl ≤0.1% on the international scale (≥3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Three years rate was displayed since the majority of imatinib participants had first MMR by Year 2."|144 weeks|Subgroup of participants from ITT population who had MMR.||Percentage of Participants||95% Confidence Interval|Number
127548|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.||geometric mean titer||95% Confidence Interval|Geometric Mean
127508|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks|"The Kaplan-Meier curve was generated based on the first date of confirmed CHR until the first date of loss of CHR, objectively documented, for responders only. Participants without confirmed loss of response were censored at the last valid hematologic assessment.~CHR must have been of at least 4 weeks in duration confirmed by 2 assessments at least 4 weeks apart and was defined as follows: white blood cells ≤ institutional upper limit of normal, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, absolute neutrophil count ≥1.0*10^9/L, platelets ≥100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly).~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CHR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CHR.||Percentage of Participants||95% Confidence Interval|Number
127509|NCT00574873|Secondary|Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks|"The Kaplan-Meier curve was generated based the time from the first date of CCyR until the first date of confirmed loss of CCyR, objectively documented, for responders only. Participants without confirmed loss of CCyR were censored at the last valid cytogenetic assessment.~CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or <1% Bcr-Abl fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.~The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided. Four years rate was displayed since the majority of participants had first CCyR by Year 1."|192 weeks|Subgroup of participants from ITT population who had CCyR.||Percentage of Participants||95% Confidence Interval|Number
127510|NCT00574873|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Year 1|Molecular response was assessed using Bcr-Abl transcript levels measured by reverse transcriptase polymerase chain reaction (RT-PCR) from peripheral blood. A MMR was defined as a ratio Bcr-Abl/Abl less than or equal to (≤) 0.1% on the international scale (greater than or equal to [≥] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) with at least 3000 Abl analyzed.|Year 1 (48 weeks)|ITT Population||Percentage of Participants||95% Confidence Interval|Number
127511|NCT00574873|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 percent (%) Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or less than (<) 1% breakpoint cluster region Abelson protooncogene (Bcr-Abl) fusion product among cells in a BM sample or peripheral blood sample when at least 200 cells were analyzed.|Year 1 (48 weeks)|Intent-to-treat (ITT) population - included all participants who were randomized to test article.||Percentage of Participants||95% Confidence Interval|Number
127512|NCT00574847|Primary|Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|week 6|Subjects who completed.||percentage of participants|||Number
127513|NCT00574847|Secondary|Exercise Stressed-induced Myocardial Ischemia (ESIMI)|End point values adjusted for baseline values age and sex.|6 week|ITT, 7 subject excluded from analysis due to missing data.||percentage of change||95% Confidence Interval|Number
127514|NCT00574847|Secondary|Spielberger State-Trait Anxiety Inventory Scales (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex.|6 weeks|ITT||units on a scale||95% Confidence Interval|Mean
127515|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Hostile Affect Sub-scale|hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.||units on a scale||95% Confidence Interval|Mean
127516|NCT00574847|Secondary|Cook-Medley Hostility (Ho) Scale|Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex.|6 weeks|ITT, 1 subject excluded from analysis due to missing data.||units on a scale||95% Confidence Interval|Mean
127517|NCT00574847|Secondary|Perceived Stress Scale|Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex.|6 weeks|ITT||units on a scale||95% Confidence Interval|Mean
127518|NCT00574847|Secondary|Platelet Serotonin Binding Affinity Kd_100|End point values adjusted for baseline values age and sex.|6 weeks|ITT, 27 subjects were excluded from analysis due to missing data.||nM||95% Confidence Interval|Mean
127519|NCT00574847|Secondary|5HTT, Serotonin Transporter Protein|End point values adjusted for baseline values age and sex.|week 6|ITT, 29 subjects excluded from analysis due to missing data.||fmol/mg||95% Confidence Interval|Mean
127520|NCT00574847|Secondary|Mental Stress Induced Change in Heart Rate|"A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs.~Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex."|baseline, 6 weeks|ITT, 10 subjects excluded from analysis due to missing data.||beats/minute||95% Confidence Interval|Mean
127521|NCT00574847|Secondary|Beck Depression Inventory|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex.|6 week|ITT||units on a scale||95% Confidence Interval|Mean
127522|NCT00574847|Secondary|Percentage of Participants With Adverse Events||Baseline to week 6|||percentage of participants|||Number
127523|NCT00574847|Secondary|Mental Stress Induced Change of Diastolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from the analysis due to missing data.||mm Hg||95% Confidence Interval|Mean
127524|NCT00574847|Secondary|Mental Stress Induced Change of Systolic Blood Pressure|Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex.|Baseline, week 6|ITT, 9 subjects excluded from analysis due to missing data.||mm Hg||95% Confidence Interval|Mean
127525|NCT00574847|Primary|Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors|MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks.|Week 6|Intent-to-treat (ITT)||percentage of participants||95% Confidence Interval|Number
127526|NCT00574834|Primary|Changes in Insulin Sensitivity|Measures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.|6 months|||mg/kg/min||Standard Error|Mean
127527|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12-15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
127528|NCT00574795|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 12 - 15 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
127529|NCT00574795|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one mone month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
127530|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
127531|NCT00574795|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
127532|NCT00574795|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
127533|NCT00574704|Secondary|Safety and Tolerability of the Study Treatment by Collection of Adverse Events||about 30 min. at each visit||||||
127549|NCT00574548|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.||geometric mean titer||95% Confidence Interval|Geometric Mean
127534|NCT00574704|Primary|Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)|"The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).~The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2."|baseline versus 2 months after baseline|||Factor of Increased Allergen Tolerance||Inter-Quartile Range|Median
127535|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127536|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127537|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC , respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127538|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127539|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])|Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127540|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127550|NCT00574405|Secondary|Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.||12 months||||||
127551|NCT00574405|Secondary|Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.||12 months||||||
127552|NCT00574405|Secondary|Changes in Daily Insulin Requirements Over Time||12 months||||||
127541|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127542|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127543|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127544|NCT00574548|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Safety population includes all participants who receive at least 1 dose of study vaccine. N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.||percentage of participants|||Number
127545|NCT00574548|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.||geometric mean titer||95% Confidence Interval|Geometric Mean
127546|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 23vPS; Year 1) time points.||geometric mean titer||95% Confidence Interval|Geometric Mean
127547|NCT00574548|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)|Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)|Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 13vPnC; Year 1) time points.||geometric mean titer||95% Confidence Interval|Geometric Mean
127553|NCT00574405|Secondary|Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.||12 months||||||
127555|NCT00574340|Primary|Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound|A measure of the baseline arterial dilation is compared to the post intervention measure of dilation of the brachial artery.|6 hours|||percentage of change||Standard Error|Mean
127556|NCT00574275|Secondary|Number of Participants With Anti-drug Antibodies|Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. The validated lower limit of detection (LLOD) for the assay was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.|Up to 90 days post last dose of study drug|Safety population with samples available for analysis||participants|||Number
127557|NCT00574275|Secondary|Safety-Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the signature of informed consent until 30 days after the last administration of study treatment, were recorded. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30 days after treatment discontinuation. SAEs and related AEs were followed till resolved or stabilized.|The safety population included all randomized participants who were administered at least 1 dose of study medications (placebo, aflibercept, or gemcitabine). For safety analyses, participants were analyzed according to the treatment received.||participants|||Number
127558|NCT00574275|Secondary|Clinical Benefit|"Clinical benefit was to be assessed in all participants by time to symptom worsening (TTSW), evaluated from the time of randomization to symptom worsening, as well as by improvement in tumor related symptoms.~However, this analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, analysis for this endpoint was not performed.|||||
127559|NCT00574275|Secondary|Objective Response Rate (ORR) Assessed by the Investigators According to RECIST Criteria|"Objective response (OR) included complete response [CR] and partial response [PR]. OR was to be assessed by the Investigators according to RECIST criteria, and confirmed by repeating tumor imaging at least 4 weeks after the first radiological documentation of response.~CR would reflect the disappearance of all tumor lesions and PR would reflect a defined reduction of tumor burden.~However, OR analysis was not performed, as the study was terminated due to futility."|From the first randomization until the end of the study data cutoff date (approximately 2 years)|Since the study was terminated due to futility, this analysis was not performed.|||||
127560|NCT00574275|Secondary|Progression Free Survival (PFS) Based on Response Evaluation Criteria in Solid Tumors [RECIST] Criteria|"PFS was the time interval from the date of registration to the date of progression, or death from any cause if it occurs before tumor progression is documented. Tumor progression was assessed using RECIST criteria, by which progression was a pre-defined increase in the size of existing tumors or appearance of one or more new tumors.~If a participant did not progress or die, the progression was censored to the date of the last valid tumor assessment or data cut-off, whichever was earlier.~Median PFS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.||months|Participants|95% Confidence Interval|Median
127561|NCT00574275|Primary|Overall Survival (OS)|"OS is the time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, data on OS were censored at the earlier of the last date participant was known to be alive, or the study data cutoff date (11 September 2009).~OS time was estimated from Kaplan-Meier Plots."|From the first randomization until the end of study data cutoff date (approximately 2 years)|Intent-to-treat (ITT) population, which included all randomized participants.||months|Participants|95% Confidence Interval|Median
127562|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 8 is calculated as (Week 8 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 8|Of the ITT analysis set, participants with an SF-36 score both at Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.||percent change in score||Standard Deviation|Mean
127563|NCT00574249|Secondary|Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)|Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) is a participant-reported outcome that employs a questionnaire that asks for the participant's views about their health. Percent change at Week 16 is calculated as (Week 16 SF-36 PCS minus Week 0 SF-36 PCS) divided by Week 0 SF-36 PCS. Positive percent change in score indicates improvement, with best improvement 100%.|Week 0 and Week 16|Of the ITT analysis set, participants with an SF-36 score at both Baseline and Week 16. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.||percent change in score||Standard Deviation|Mean
127564|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 12|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 12. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
127574|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 4|ITT analysis. Imputation of missing values at Week 4 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
127565|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 8|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 8. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
127566|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 4|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 4. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in the analysis of percent change.||percent change in score||Standard Deviation|Mean
127567|NCT00574249|Secondary|Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 2|Of the ITT analysis set, participants with DLQI scores at both Baseline and Week 2. Imputation of missing values using LOCF. Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
127568|NCT00574249|Secondary|Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)|DLQI is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which (i.e., how much) the subject's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. Total score range: 0 (best) to 30 (worst). Negative change and percent change from Baseline indicate improvement, with best improvement -100%.|Week 0 and Week 16|Of the ITT analysis set, participants with DLQI scores both at Baseline and Week 16. Imputation of missing values using last observation carried forward (LOCF). Participants with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Standard Deviation|Mean
127569|NCT00574249|Secondary|Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 16|ITT analysis. Imputation of missing values at Week 16 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
127570|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 12|ITT analysis. Imputation of missing values at Week 12 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
127571|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 8|ITT analysis. Imputation of missing values at Week 8 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
127572|NCT00574249|Other Pre-specified|Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.|NAPSI is a sum of 2 scores that grade nail matrix psoriasis (based on presence/absence of pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (based on presence/absence of onycholysis splinter hemorrhages, oil drop [salmon patch] discoloration, and nail bed hyperkeratosis). Each fingernail is given a single score based on presence of psoriasis in quadrant of nail: 0 (none) to 4 (present in 4/4 nail quadrants). Score range: 0 (best) to 80 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a NAPSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Inter-Quartile Range|Median
127573|NCT00574249|Other Pre-specified|Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.|PSSI is a physician assessment of clinical symptoms of scalp psoriasis. Computed as the sum of scores for erythema, induration, and desquamation (1 = absent; 4 = severest possible) multiplied by involved area (0 = 0%; 6 = 90-100%). Total score range: 0 (best) to 72 (worst). Negative change and percent change from Baseline indicate improvement.|Week 0 and Week 16|Of the ITT analysis set, participants with a PSSI score at both Baseline and Week 16. Imputation of missing values using LOCF. Subjects with a zero score at Baseline were not included in analysis of percent change.||percent change in score||Inter-Quartile Range|Median
127589|NCT00574067|Secondary|Criminal Activity|Days of crime during the past 30 days|1 year|||days||Standard Deviation|Mean
127590|NCT00574067|Secondary|Number of Days of Cocaine Use|Number of days used cocaine during the past 30 days.|1 year|||days||Standard Deviation|Mean
127575|NCT00574249|Secondary|Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2|PGA is a physician's assessment of severity of disease (grading lesion severity). PGA scores range from 0 (best) to 6 (worst): on the 6-point scale, a score of 0 = Clear and a score of 6 = Very Severe for the lesion severity. PGA Clear (0) is no plaque elevation over normal skin and no scale with or without erythema. Minimal (1) is possible plaque elevation but difficult to ascertain a slight elevation above normal skin. Percentage of participants: 0% to 100% (best).|Week 2|ITT analysis. Imputation of missing values at Week 2 as not achieving PGA of Clear or Minimal.||percentage of participants|||Number
127576|NCT00574249|Secondary|Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)|PASI100 is defined as at least a 100% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst) with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 100% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
127577|NCT00574249|Secondary|Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 90% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
127578|NCT00574249|Secondary|Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)|PASI50 is defined as at least a 50% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement 100%. The outcome measure is the percentage of participants who had at least a 50% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
127579|NCT00574249|Primary|Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.|Week 0 and Week 16|ITT analysis; participants with a missing PASI assessment at Week 16 were imputed as nonresponders.||percentage of participants|||Number
127580|NCT00574171|Primary|Response Rate of Lapatinib/Capecitabine.||duration of study; on average 1 year|||participants|||Number
127581|NCT00574145|Secondary|Intensity of Anxiety and Depression|Measured on the Hospital Anxiety and Depression Scale, 14 items on a 4-point scale scored from 0 = not at all (best feeling) to 3 = very often (worst feeling). Scores are summed and range from a minimum of 0 (no anxiety or depression) to 42 (worst anxiety or depression)and a median for each arm is determined at the specified timepoints.|baseline and off-radiation at 5 to 7 weeks|Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks||units on a scale||Full Range|Median
127582|NCT00574145|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Breast Form (FACT-B)|36 items that measure general quality of life (27 items) and specific breast cancer concerns (9 items) on a 5-point rating scale with 0 = not at all to 4 = very much. Minimum (worst quality of life) possible score = 0 and maximum (best quality of life) possible score = 144. Physical and emotional well-being scores were reverse coded and sub scale scores were summed. Median scores for baseline and at 6 weeks were determined|baseline and 6 weeks|Arm A:1 patient was accidentally notified of group assignment before final data collected, 2 patients withdrew (1 at 2 days), 1 at 5 days. )Arm B: 1 patient withdrew at 4 weeks||units on a scale||Full Range|Median
127583|NCT00574145|Primary|Fatigue Using the Brief Fatigue Inventory (BFI)|9-items with an 11-point rating scale measures intensity of fatigue (3 items, 0 = no fatigue to 10 = fatigue as bad as you can imagine) and interference of fatigue on daily life (6 items, 0 = does not interfere to 10 = completely interferes. Each participant's score is summed with a possible minimum score of 0 and a possible maximum score of 90. A mean score was then determined.|6 weeks|Patients who completed 5 of 8 maximum collection points. Arm A: 1 patient withdrew at 2 days, 1 patient withdrew at 5 days. Arm B: 1 patient withdrew at 4 weeks||units on a scale||Standard Deviation|Mean
127584|NCT00574080|Secondary|Side Effects With Both Transplant Regimens|side effects from adding three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan)vs. side effects of treatment with high-dose chemotherapy not containing these drug|24 months||||||
127585|NCT00574080|Primary|Addition of Bortezomib, Thalidomide, and Dexamethasone to High Dose Chemotherapy Regimen Immediately Before Transplant|To find out if adding, bortezomib, thalidomide, and dexamethasone to the high dose chemotherapy regimen immediately before transplant will result in better myeloma response and longer survival of myeloma subjects compared to treatment with high-dose chemotherapy.|24 months|no analysis, participants either died or were withdrawn by PI. study terminated with <10% of target accrual enrolled.||participants|||Number
127586|NCT00574067|Secondary|HIV Risk Behavior|Number of times had sex without using a condom during the past year|1 year|||times||Standard Deviation|Mean
127587|NCT00574067|Secondary|HIV Risk Behavior Needle Sharing|Number of times shared a needle during the past year|1 year|||times||Standard Deviation|Mean
127588|NCT00574067|Secondary|Employment Status|Number of days employed during the past year|1 year|||days||Standard Deviation|Mean
127593|NCT00573937|Secondary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain.|48 hours|Due to slow accrual, the study was terminated and no data were analyzed.|||||
127594|NCT00573937|Primary|Change in Numeric Pain Scale Score|Subjects will be verbally questioned about their pain on a scale from 0 to 10, with 0 being symptoms are absent to 10, the worst possible pain. Response to treatment is defined as a 33% reduction in pain score from the baseline to the Week 4 pain score.|Baseline, Week 4|Due to slow accrual, the study was terminated and no data were analyzed.|||||
127595|NCT00573859|Secondary|The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.|The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.|4 days|||scores on a scale||Full Range|Median
127596|NCT00573859|Secondary|The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.|In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.|4 days|||errors||Standard Error|Mean
127597|NCT00573859|Primary|The Effects of ADHD Medication Versus Placebo on Cotinine Levels|Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.|4 days|Smokers with ADHD||ng/ml||Standard Error|Mean
127598|NCT00573768|Primary|Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.|Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)|change from baseline (on day 1) to day 5|Intent to treat (ITT)||mm||Standard Deviation|Mean
127599|NCT00573755|Secondary|Adverse Event|Number of participants that experienced adverse events (grade 3 and above) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Adverse events were assessed every week during first 6 weeks of therapy, every 4 weeks on months 1 to 6, every 12 weeks on months 7 and beyond and at the end of treatment.|Time from randomization to end of treatment|||participants|||Number
127600|NCT00573755|Secondary|Duration of Response|Duration of response was defined for all patients who have achieved a confirmed response as the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.|||||
127601|NCT00573755|Secondary|Objective Tumor Response Rate|A confirm response was defined as either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluation at least 4 weeks apart. The confirmed response rate was estimated within each treatment group by the number of confirmed responses divided by the total number of participants randomized.|Up to 5 years|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.|||||
127602|NCT00573755|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of the randomization to the date at which the patient was removed from treatment due to progression, adverse events, or refusal.|Time from randomization to treatment failure (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome.|||||
127603|NCT00573755|Secondary|Overall Survival|Survival time was defined as the time from randomization to death due to any cause.|Time from randomization to death (up to 5 years)|The number of patients enrolled in the study does not allow for meaningful analysis for this outcome. All patients were alive at the time of their last treatment follow up.|||||
127604|NCT00573755|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment and then never return for any evaluations, the participant was censored for progression 1 day post-randomization.|Time from randomization to disease progression or death (up to 5 years)|All participants who have met the eligibility criteria, signed a consent form and were randomized to one of the two treatment groups were evaluable for the primary endpoint.||months||95% Confidence Interval|Median
127605|NCT00573534|Secondary|Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology.|This outcome measure integrates data from self report supplied in the Time Line Follow Back (a self report summary of all substance and alcohol use over the previous week or month) with evidence from periodic (weekly to monthly) urine toxicologies.|up to 24 weeks|The 8 subjects who took at least one dose of the medication and returned for follow up were included.||participants|||Number
127606|NCT00573534|Primary|Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit|The outcome is the number of subjects who achieved a clinically meaningful reduction in ADHD symptoms. This is defined as a 70% reduction from baseline as measured by change in the ADHD Rating Scale (ADHD-RS). The ADHD RS quantifies symptoms on a 0-3 scale, 0 meaning never present, 1 sometimes, 2 often present, 3 very often present. For this study, the scale was clinician administered using both parent and adolescent to achieve a consensus score, or a best estimate on the clinician's part when consensus could not be achieved|up to 24 weeks|All patients who agreed to participate. Last Observation Carried Forward was used final outcome.||participants|||Number
127607|NCT00573508|Secondary|Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary|"The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids.~Change from baseline with a lower score indicates an improvement.~End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table.~Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The number of participants for each timepoint / parameter are noted in the category titles."||Number of Category Events / 24 Hours||Standard Deviation|Mean
127608|NCT00573508|Secondary|Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)|"The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely).~Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study.~Change is calculated as EOT - Baseline"|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each row are noted in the category titles."||TS-VAS||Standard Deviation|Mean
127609|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.|"ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized female patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||ICIQ-FLUTSsex||Standard Deviation|Mean
127610|NCT00573508|Secondary|Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.|"ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12.~Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized male patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||ICIQ-MLUTSsex||Standard Deviation|Mean
127611|NCT00573508|Secondary|Change From Baseline in the MCUI Behavior Therapy Stratified|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.||Number of Days||Standard Deviation|Mean
127612|NCT00573508|Secondary|Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months|"MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care.~A negative score in Change from Baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS):all randomized patients who took at least 1 dose of double-blind study medication & had an assessment in OAB-q at both baseline & at least 1 post-baseline visit. The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint/ parameter are noted in the category titles.||Number of categorical items||Standard Deviation|Mean
127613|NCT00573508|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI)|"The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting.~A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study.~Change from baseline is based on the ANCOVA model after adjusting baseline value & center."|Baseline and 12 Weeks|"Population is full analysis set (FAS): all randomized patients who took at least 1 dose of double-blind study drug & had an OAB-q assessment at both baseline & at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each timepoint / parameter are noted in the category titles."||Percentage of indicated parameter||Standard Deviation|Mean
127614|NCT00573508|Secondary|Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated End of Treatment (EOT) for each sub-domain – Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~Number of participants analyzed per arm represents FAS. The numbers of participants for each visit/sub domain are noted in the category titles."||OAB-q HRQL Sub Domain Score||Standard Deviation|Mean
130140|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients||Participants|||Number
127615|NCT00573508|Secondary|Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire|The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy.|Baseline and 12 Weeks|"The number assessed included all participants who completed the BSW questionnaire at baseline visit (visit 2) and end of treatment (visit 5/early withdrawal).~A few patients who completed the BSW Questionnaire did not adequately complete the  Benefits Section and therefore are considered 'N/A' for that Section."||Participants|||Number
127616|NCT00573508|Secondary|Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)|"The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems~Improvement is defined by any reduction in PPBC score.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment (EOT) - Baseline"|Baseline and 12 Weeks|Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.||Participants|||Number
127617|NCT00573508|Secondary|Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement.~Change is calculated as Actual Data for each time point - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||OAB-q HRQL Total Score||Standard Deviation|Mean
127618|NCT00573508|Secondary|Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~Change is calculated as Actual Data for each timepoint - Baseline."|Baseline, Week 4, Week 8 and Week 12|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||OAB-q Score||Standard Deviation|Mean
127619|NCT00573508|Primary|Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score|"The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100.~Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement.~End of Treatment results include patients who had early discontinuation from the study.~Change is calculated as End of Treatment - Baseline."|Baseline and 12 Weeks|"Population is full analysis set(FAS): all randomized patients who took at least 1 dose of double-blind study medication and had an assessment in OAB-q at both baseline and at least 1 post-baseline visit.~The number of participants per arm is consistent for all categories / rows of the data table."||OAB-q Score||Standard Deviation|Mean
127620|NCT00573469|Secondary|Change in CDAI Score From Baseline to 8 Weeks|CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.|Baseline to 8 weeks|||Score on a scale||Standard Deviation|Mean
127621|NCT00573469|Secondary|Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method|Time from randomisation to the remission of Crohn's disease defined as CDAI score  150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.|At 8 weeks|||Percentage of participants|||Number
127622|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 4 weeks|||Participants|||Number
127623|NCT00573469|Secondary|Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment|The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.|Baseline to 2 weeks|||Participants|||Number
127624|NCT00573469|Primary|Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment|Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.|Baseline to 8 weeks|||Participants|||Number
127625|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects|Subjects with MS were instructed to also record daily the pain they experienced using the PRS. After evaluating the subject's ability to comply with these requirements, the investigator determined if a caregiver should complete the study diary and assessments. Subjects rated their pain over the past 12 hours on a scale of 0 to 10 (0=none, 10=worst pain ever experienced).|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population - MS Subjects only||Scores on a Scale||Standard Deviation|Mean
127626|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score|The BDI-II is a 21-item self report instrument intended to assess the existence and severity of symptoms of depression, summed to give a single score. The BDI-II uses a 4-point for each item ranging from 0 to 3. A total score of 0-13 is considered minimal range, 14 to 19 is mild, 20 to 28 is moderate, and 29 to 63 is severe.|Baseline and Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
127627|NCT00573443|Secondary|Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category|The SF-36 is designed to examine a person’s perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 – 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline and Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
127628|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
127629|NCT00573443|Secondary|Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population)|The NPI is a retrospective (to 1 month) caregiver-informant interview assessing frequency and severity of 12 neuropsychiatric symptom domains. The NPI score is based on the sum of the severity ratings (0=absent, 1=mild, 3=severe). The 12 symptom domains include delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, euphoria/elation, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviors, nighttime behavioral disturbances, and appetite/eating abnormalities. The NPI severity score is based on severity ratings (0=absent, 1=mild to 3=severe).|Baseline to Day 84|Efficacy Evaluable (EE) Population - included all subjects who were protocol adherent, defined as those who completed the Day 84 visit or the end-of-study visit within 48 hours of a discontinuation, and who took as least 80% of their scheduled doses prior to discontinuation of the study medication.||Scores on a Scale||Standard Deviation|Mean
127630|NCT00573443|Secondary|Mean Change From Baseline in CNS-LS Total Score by Visit|Center for Neurologic Studies-Lability Scale (CNS-LS) is an instrument for the measurement of PBA that has been validated for the use in patients with ALS and MS. It is a 7-item self-report questionnaire that measures the frequency and severity of PBA episodes, including assessments of labile laughter and labile tearfulness,and provides a score for total PBA (total score can range from 7-35). The following 5-point scoring was used: 1=Applies never, 2=Applies rarely, 3=Applies occasionally, 4=Applies frequently, 5=Applies most of the time. A score of 13 or higher may suggest PBA, and the higher the score the more severe the episodes.|Baseline, Day 15, Day 29, Day 57, Day 84|ITT Population||Scores on a Scale||Standard Deviation|Mean
127631|NCT00573443|Primary|PBA Episode Rate Ratio (Post/Pre), Regression Adjusted|Episodes were counted each day and recorded in a daily diary. The outcome measure is the ratio of the episode rate over the 84-day treatment period to the rate during the baseline period, adjusted for study site, and underlying disease using longitudinal negative binomial regression.|Baseline to Day 84|Intent-to-Treat (ITT) population - included all randomized subjects for the double-blind phase and all enrolled subjects for the open-label extension phase.||Unit-free (ratio of episodes/week)||95% Confidence Interval|Least Squares Mean
127632|NCT00573430|Secondary|Treatment-emergent Adverse Events|Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.|Baseline to 28 weeks|||Participants|||Number
127633|NCT00573430|Secondary|Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation|GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)|28 weeks|||mL/min/1.73 m2||Standard Deviation|Mean
127634|NCT00573430|Secondary|Inflammatory Marker (Hs-C-peptide Reactive Protein)|To evaluate how to reduce and relate with cardiovascular risk|baseline to 28 weeks|||mg/dL||Standard Deviation|Mean
127635|NCT00573430|Secondary|Change of Systolic and Diastolic Blood Pressure From Baseline||baseline to 28 weeks|||mmHg||Standard Deviation|Mean
127636|NCT00573430|Primary|The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks|Decrease of urinary protein/creatinine ratio means improvement of renal disease.|baseline to 28 weeks|||mg/g||Standard Deviation|Mean
127637|NCT00573391|Primary|Participant Survival With Velcade/Melphalan/Dexamethasone Treatment vs. Participant Survival With Velcade/Thalidomide/Dexamethasone Treatment|due to low accrual rates, no analyses was done to compare the new combination of Velcade/Melphalan/Dexamethasone vs. Velcade/Thalidomide/Dexamethasone|24 months|||Participant|||Number
127638|NCT00573313|Secondary|Changes in Serum SAM|We compared serum levels of SAM at time 0 and week 24 of the study in the alcoholic liver disease groups only, since these parameters were measured in the healthy and lifestyle coaching groups only at baseline.|September 2005- June 2009|Whereas 37 subjects started the protocol, due to protocol violation, there remained 26 subjects, 13 in each group, for final analyses. Here are reported changes in AST values to represent all variables.||nmol/liter||Full Range|Median
127639|NCT00573313|Primary|Changes in Serum AST Levels|Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.|Week 0 to week 24|Analysis of AST values was based on numbers of participants in each group who completed the study. Analysis is pre-specified to apply only to subjects with alcoholic liver disease.||Units per liter (U/L)||Full Range|Median
127641|NCT00573287|Primary|Number of Participants Demonstrating Improvement in Substance Use|"Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on cannabis use was gathered weekly using the TLFB method. At the end of the study, graphs were plotted showing days of cannabis use per week and rated as “Improved,” “Unchanged,” or “Worse” by a pair of expert judges. Raters were instructed to rate the graph “Improved” or “Worsened” if it appeared to be >20% better or worse and to rate it Unchanged if there was little or no change (less than ~20%)."|24 weeks|Analysis was conducted for participants who were randomized to study medciation condition and actually began treatment with study drug and had a follow-up visit. Two patients (one in the Clozapine group and one in the Risperidone group) did not meet this criteria and were not included i the analysis.||participants|||Number
127642|NCT00573261|Secondary|To Assess the Change in Disability Scale Upon Treatment of Pregabalin in Comparison to Placebo.|The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired).|baseline and at end of a 4-week intervention|||units on a scale||Standard Deviation|Mean
127643|NCT00573261|Secondary|To Assess the Change of Depressive Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms)|baseline and at end of a 4-week intervention|||units on a scale||Standard Deviation|Mean
127644|NCT00573261|Secondary|To Assess the Change of Anxiety Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety).|baseline and at end of a 4-week intervention|||units on a scale||Standard Deviation|Mean
127645|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention|||Ratio||Standard Deviation|Mean
127646|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50).|baseline and at end of a 4-week intervention|||Intervals more than 50 ms||Standard Deviation|Mean
127647|NCT00573261|Primary|Assessing the Change of Parameters of Autonomic Nerve Function Such as Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||milliseconds||Standard Deviation|Mean
127648|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/[total power-VLF]) and normalized HF (normalized HF=HF/[total power-VLF]).|baseline and at end of a 4-week intervention|||Ratio||Standard Deviation|Mean
127649|NCT00573261|Primary|Assessing the Change in Heart Rate Variability by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz).|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||Hertz (Hz)||Standard Deviation|Mean
127650|NCT00573261|Primary|Assessing the Change in Heart Rate by Means of the LifeShirt System Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.|The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram.|baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||Beats Per Minute||Standard Deviation|Mean
127663|NCT00573170|Secondary|Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
127651|NCT00573261|Secondary|To Assess the Change of Pain Symptoms Upon Treatment of Pregabalin in Comparison to Placebo.|Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain.|baseline and end of 4 week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and their 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||units on a scale||Standard Deviation|Mean
127652|NCT00573261|Primary|Assessing the Change in Resting Blood Pressure Upon Treatment of Pregabalin vs. Placebo in Patients With Diabetes and Peripheral Neuropathy.||baseline and at end of a 4-week intervention|A data card failure of the baseline heart rate record with the VivoMetrics system occurred for one subject who had completed baseline and 4-week assessments, leaving 28 subjects (n=13 in placebo, n=15 in pregabalin)having both completed baseline and end of 4-week R-R intervals for heart rate variability analysis.||mm Hg||Standard Deviation|Mean
127653|NCT00573248|Primary|Side Effects|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|||Percent of item endorsement||Standard Error|Mean
127654|NCT00573248|Primary|Negative Moods|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|||Percent of item endorsement||Standard Error|Mean
127655|NCT00573248|Secondary|Blood Pressure|Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches|4 days|||mm HG||Standard Deviation|Mean
127656|NCT00573248|Primary|ADHD Symptoms|Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches|4 days|Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo.||Percent of item endorsement||Standard Error|Mean
127657|NCT00573183|Secondary|Attendance at 12-step Meetings|Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period|6 months|The sample size was originally powered based on the primary outcome measure, not on the secondary 12-step measures.The analysis sample size was reduced due to missing values||days of attending 12-step meetings||Standard Deviation|Mean
127658|NCT00573183|Primary|Days of Stimulant Use|Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period|6 months|The original sample size was based on power analysis and took attrition into account. Of the 471 individuals randomized to treatment, 50 subjects (TAU, n=20, STAGE-12, n=30) did not have any post-baseline measures and were therefore eliminated from the statistical analysis of the primary outcome and some of the secondary outcomes.||days of stimulant use||Standard Deviation|Mean
127659|NCT00573170|Secondary|"Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire)"|"Clinical disability for each participant was assessed using the CDQ. This scale uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is normal/not impaired, 2 is mildly impaired, 3 is moderately impaired, 4 is severely impaired, and 5 is 'required bedrest."|At dosing and at 2, 4, 6 and 8 hours after dosing of each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
127660|NCT00573170|Secondary|Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
127661|NCT00573170|Secondary|Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
127662|NCT00573170|Secondary|Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
127664|NCT00573170|Secondary|Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine|The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.|At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population: those participants who provided any information for the PPMQ-R.||scores on a scale||Standard Error|Mean
127665|NCT00573170|Secondary|Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|"Participant alertness was evaluated with the 7-point modified SS scale, where 1 is feeling active, vital, alert, wide awake, 2 is still functioning at high levels, but not peak; able to concentrate, 3 is awake, but relaxed; responsive but not fully alert, 4 is somewhat foggy, let down, 5 is foggy, losing interest in remaining awake, 6 is sleepy, woozy, fighting sleep, prefer to lie down, and 7 is no longer fighting sleep, sleep onset soon, having dream like thoughts."|Dose time, 2, 4, 6, 8, 24 and 48 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population. Only participants who responded to the SS scale at a particular time point were included in the analysis for that time point.||units on a scale||Standard Deviation|Mean
127666|NCT00573170|Secondary|Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Overall cognition was assessed with a composite score (range 0-9) called the Performance Index, as derived from the number of correct responses per minute on subtests of the Mental Efficiency Workload Test (MEWT) cognitive battery. For a particular participant, lower scores indicate a negative impact, or worsened, general cognition; higher scores indicate improved cognition.|At time of dosing, and at 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||scores on a scale||Standard Deviation|Mean
127667|NCT00573170|Secondary|Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing|Complete symptom-free is defined as migraine-free, neck pain-free, and sinus pain-free without the use of any rescue medication prior to the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
127668|NCT00573170|Secondary|Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain|Pain relief is defined as having no or mild pain and no use of rescue medication after dosing in those participants who had moderate or severe pain at dosing.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - only participants who reported moderate or severe baseline pain were included in this analysis.||participants|||Number
127669|NCT00573170|Secondary|Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline|The number of participants with no pain and relief of neck pain in those participants for whom neck pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported neck pain at dose time.||participants|||Number
127670|NCT00573170|Secondary|Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing|The number of participants with no pain and relief of sinus/facial pain in those participants for whom sinus/facial pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported sinus/facial pain at dose time.||participants|||Number
127671|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose|The number of participants with no pain and relief of vomiting in those participants for whom vomiting was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported vomiting at dose time.||participants|||Number
127672|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of phonophobia in those participants for whom phonophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported phonophobia at dose time.||participants|||Number
127682|NCT00573157|Secondary|Number of Participants With New Lupus Flares||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.|||||
127683|NCT00573157|Secondary|Percentage of Participants With Normalization of Renal Function||At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.|||||
127673|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of photophobia in those participants for whom photophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported photophobia at dose time.||participants|||Number
127674|NCT00573170|Secondary|Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points|The number of participants with no pain and relief of nausea in those participants for whom nausea was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population - including only those participants who reported nausea at dose time.||participants|||Number
127675|NCT00573170|Secondary|Number of Participants With a Migraine-free Response 2-48 Hours After Dosing|Migraine-free is defined as pain-free with no migraine-associated symptoms (nausea, vomiting, photophobia [sensitivity to light], and phonophobia [sensitivity to sound]) with use of any rescue medication before the defined time point.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
127676|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their third migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 3 with study medication and then used migraine rescue medication after dosing.||hours||Standard Deviation|Mean
127677|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their second migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 2 with study medication and then used migraine rescue medication after dosing.||hours||Standard Deviation|Mean
127678|NCT00573170|Secondary|Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)|Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for the first migraine attack treated. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Participants in the ITT population who treated migraine Attack 1 with study medication and then used migraine rescue medication after dosing.||hours||Standard Deviation|Mean
127679|NCT00573170|Secondary|Number of Participants Using Rescue Medication Within 48 Hours Post Dose|Number of participants who took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.|From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
127680|NCT00573170|Secondary|Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose|Pain-Free is defined as having no pain and without the use of any rescue medication from the time of the initial dose of study medication for a particular migraine attack until the defined time point at 2, 4, 6, 8, 24 or 48 hours post-dose.|At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|ITT Population||participants|||Number
127681|NCT00573170|Primary|Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose|SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.|From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).|Intent-to-Treat (ITT) Population: all participants who were treated with investigational product and provided at least one post-dose efficacy assessment . Participants may have been included in one, two, or all of the Placebo, Treximet and Butalbital-containing combination medication arms due to the cross-over nature of the study design.||participants|||Number
127684|NCT00573157|Primary|Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response|Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate [GFR]), improvement in proteinuria (urine protein/creatinine ratio <0.5) & resolution of hematuria. Partial response (PR): from baseline, a <= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) & resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.|At Week 52|Due to early termination of the study caused by unanticipated safety issues, the outcome measure was not assessed.|||||
127685|NCT00573144|Secondary|Myocardial Infarct Size at 30 Days|Myocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack. Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply. The resulting heart tissue lesion is referred to as an infarct. A larger size or area of infarct indicates a greater amount of heart tissue death. Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%.|30 days|||percentage of total cardiac tissue mass||Standard Deviation|Mean
127686|NCT00573144|Secondary|Change in Left Ventricular End-Systolic Diastolic Volume Index|Change in Left Ventricular end-systolic diastolic volume index determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart’s major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days|||mL blood/meter^2 body surface area||Standard Deviation|Mean
127687|NCT00573144|Primary|Change in Left Ventricular End-Systolic Volume Index|Change in Left Ventricular end-systolic volume index as determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days. The MUGA scan is a noninvasive tool for assessing the function of the heart. The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart’s major pumping chambers). End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.|baseline, 30 days|||mL of blood/meter^2 body surface area||Standard Deviation|Mean
127688|NCT00573131|Primary|Overall Tumor Response at the Primary Tumor Site Based on Measurement of Primary Tumor Volume (Excluding Involved Lymph Nodes) by Spiral CT||Screening and Week 12|Subjects who received at least one treatment with OncoGel, systemic chemotherapy or external beam radiation therapy were included for analysis of efficacy.||percentage of patients|||Number
127689|NCT00573066|Primary|PK Profile of Dexmedetomidine|This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.|after start of infusion (0.5, 1, 2, 4-6 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2, 4, 8, 12, 15-18 hours)|Based on an estimated inter-subject variability of 50% for steady state concentration, a sample size of 36 evaluable subjects will be sufficient to detect a difference (alpha 0.05, power 0.8) for the area under the concentration-time curve (AUC) and steady state concentration (Css) between the three dosing groups.||mL/min/(kg^0.75)||Standard Error|Least Squares Mean
127690|NCT00572910|Primary|Number of Participants With Adverse Experiences (AE)/Serious Adverse Experiences (SAE)|"Participants with Adverse Experiences (AE) / Serious Adverse Experiences (SAE) occurring Day 1 through Day 14 following vaccinations 1, 2, and 3.~Participants with specific SAEs including any vaccine-related SAEs, any SAEs involving a Staphylococcus aureus (S. aureus) infection, or any AEs leading to death occurring Day 1 through Day 360 following vaccination."|Days 1-14 following each vaccination for any AE/SAE and Days 1-360 for any vaccine-related SAEs, S. aureus SAEs, or deaths.|||Participants|||Number
127691|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline as Measured at 8 Predefined Timepoints|Participants whose GMFR in 0657n-specific IgG antibody concentration from baseline through Day 360 for all groups (including Days 28, 56, 84,180, 210, 270, and 360) to assess the durability and kinetics of the immune response.|Prevaccination to 360 days post vaccination|||Ratio||95% Confidence Interval|Geometric Mean
127692|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to 56 Days After the Administration of a Single V710 Vaccination|Participants whose GMFR in 0657n-specific IgG antibody concentration from Baseline to Day 56 for the 2 Groups receiving a single dose of V710 (60 mcg without MAA followed by Placebo 28 Days later) Group 2, and (60 mcg with MAA followed by Placebo 28 days later) Group 4.|Prevaccination to 56 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
127693|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 180 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 180 for the 3 Groups receiving 2 doses of V710 28 days apart (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 180 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
127694|NCT00572910|Secondary|GMFR in 0657n-specific IgG Antibody Concentration From Baseline to Day 28 After the Administration of the First V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured from Baseline to Day 28 for the 3 Groups receiving 1 dose of V710 (60 mcg without MAA) Group 1 and 2 combined, (60 mcg with MAA) Group 3 and 4 combined and (90 mcg with MAA) Group 5.|Prevaccination to 28 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
127695|NCT00572910|Primary|Geometric Mean Fold-rise (GMFR) in 0657n-specific Immunoglobulin G (IgG) Antibody Concentration From Baseline to 28 Days After the Administration of the Second V710 Vaccination|Participants whose GMFR in anti-0657n IgG antibody concentration was measured by the LUMINEX™ assay from Baseline to 28 days after the administration of the second vaccination of V710 for the 3 groups receiving 2 doses of V710 (60 mcg without MAA) Group 1, (60 mcg with MAA) Group 3 and (90 mcg with MAA) Group 5.|Prevaccination to 56 days postvaccination|||Ratio||95% Confidence Interval|Geometric Mean
127696|NCT00572897|Secondary|Transplant-related Mortality|Transplant-related Mortality including Graft-versus-host disease (GVHD)|2 years|||participants|||Number
127697|NCT00572897|Secondary|PLT|Patients with PLT ≥20 × 109/L|2 years|||participants|||Number
127698|NCT00572897|Secondary|Absolute Neutrophil Count (ANC)|Patients with ANC ≥0.5 × 10^9/L|2 years|||participants|||Number
127699|NCT00572897|Secondary|Overall Survival|The number of patients alive at last follow-up.|73 months|||participants|||Number
127700|NCT00572897|Secondary|Response Outcomes|assessed according to the IWG Criteria|180 days|Clinical responses were assessed according to the IWG-MRT 2006 criteria in 46 patients (29 sibling and 17 unrelated transplants) who survived at least 180 days.||participants|||Number
127701|NCT00572897|Primary|The Primary Endpoint is Progression-free Survival.|Number of participants alive at 2 years who are progression-free|2 years|||participants|||Number
127702|NCT00572832|Primary|Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule|Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.|1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)|The analysis was by intention to treat. Participants who had positive baseline antibody titers were excluded from further analyses only for the type(s) for which they were seropositive.||milliMerck units per mL||95% Confidence Interval|Geometric Mean
127703|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT3 to Predict Lymph Node Status at Surgery|%change in SUVmax from FLT1‐FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1‐FLT3 will be consider the outcome.|Baseline (FLT-1) and post-NAC (FLT-3)|Data on 30 patients with FLT3 were available for histopathological LN evaluation after NAC: 11 with negative nodes, 13 with 1‐3 LN metastases and 6 with >3 LN metastases||percent change in SUVmax from FLT1‐FLT3||Standard Deviation|Mean
127704|NCT00572728|Secondary|%Change SUVmax From FLT1‐FLT2 to Predict Lymph Node Status at Surgery|Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome.|Baseline (FLT-1) and Early Therapy (FLT-2)|Data on 38 patients having FLT1 and FLT2 were available for histopathological LN evaluation after NAC: 14 with negative nodes, 15 with 1‐3 LN metastases and 9 with >3 LN metastases||percent change in SUVmax from FLT1‐FLT2||Standard Deviation|Mean
127705|NCT00572728|Secondary|Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor|"To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome.~Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section"|Baseline (FLT-1) and post-NAC (FLT-3)|43 patients who had both FLT1 and FLT3 scans||percentage change in SUVmax||Standard Deviation|Mean
127706|NCT00572728|Secondary|SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein.|post-NAC (FLT-3)|After completion of NAC (FLT-3): only 31 patients had both FLT3 and RCB evaluation: 11 patients with RCB 0/I and 20 patients with RCB II/III||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
127707|NCT00572728|Secondary|SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein.~Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III"|early treatment (FLT2)|after one cycle of NAC (FLT2): 35 patients had FLT-2 and RCB evaluation: 14 patients with RCB 0/I and 21 patients with RCB II/III||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
127708|NCT00572728|Secondary|SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III|"While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein.~Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III"|Baseline (FLT-1)|@ Baseline: 35 patients with FLT-1 were evaluable for RCB: 14 patients with RCB 0/I and 21 patients with RCB II/III||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
127709|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT3 (Post-NAC)|For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells.|Post-NAC (FLT3)|43 patients who had suitable post‐NAC tissue samples for correlation between surgical specimens and FLT3 SUVs||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
130141|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients||Participants|||Number
127710|NCT00572728|Secondary|Correlation Between SUVmax and Ki‐67 LI at FLT1(Baseline PET)|"For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 .~Ki‐67 labeling index (LI) was calculated as the number of Ki‐67 positive tumor cells per one thousand tumor cells."|Baseline (FLT-1)|1 of the 73 participants did not have both FLT-1 and Ki-67 LI available data||Standard Uptake Values (SUVmax)||Standard Deviation|Mean
127711|NCT00572728|Primary|%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response|The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies|Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)|Percent Change in Maximum Standardized FLT uptake between the baseline (pre-therapy, FTL-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2)||percentage change of SUVmax||Standard Deviation|Mean
127712|NCT00572572|Secondary|Preferred Treatment Cycle|Participants were asked which treatment cycles was preferable - aprepitant or placebo cycle.|2 months|There were 49 subjects during the Aprepitant treatment and the Placebo treatment for each cycle that had complete data for the analysis of the preferred treatment cycle.||percentage of subjects with a preference|||Number
127713|NCT00572572|Secondary|MD Anderson Symptom Inventory Score|The MD Anderson Symptom Inventory (MDASI) is a brief measure of the severity and impact of cancer-related symptoms. Thirteen core items measure the severity of symptoms and six additional items measure the impact of symptoms. All items are rated on a scale from 0 (not present or did not interfere) to 10 (maximal severity or interference). The mean value of the total nineteen items ranges from 0 to 10.|Days 1-8|There were 64 subjects during the Aprepitant treatment and 62 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the M.D. Anderson Symptom Inventory. The mean MDASI scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.||units on a scale||Standard Deviation|Mean
127714|NCT00572572|Secondary|Visual Analouge (VAS) 100mm Scale Score|The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. The mean VAS scores for days 1-8 combined, by treatment (Aprepitant vs. Placebo) were reported.|Days 1-8|There were 54 subjects during the Aprepitant treatment and 61 subjects during the Placebo treatment for days 1-8 that had complete data for the analysis of the visual analouge scale for nausea and vomiting.||mm||Standard Deviation|Mean
127715|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 6-8.|Participants were evaluated from cycle days 6-8.|||percentage of evaluable subjects|||Number
127716|NCT00572572|Secondary|Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)|Proportion of patients with no emesis regardless of use of rescue medication during cycle days 1-5.|Participants were evaluated from cycle days 1-5.|||percentage of evaluable subjects|||Number
127717|NCT00572572|Primary|Complete Response.|Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.|Participants were evaluated from start of treatment through day 8 of cycle 2.|||percentage of evaluable subjects|||Number
127718|NCT00572533|Post-Hoc|RBC Units Transfused|Total number of RBC units transfused|12 months|Intent-To-Treat, Missing Data Excluded||RBC Units|||Number
127719|NCT00572533|Post-Hoc|Subjects Receiving Transfusion|Number of Subjects receiving Transfusion|12 months|Intent-To-Treat, Missing Data Excluded||Participants|||Number
127720|NCT00572533|Secondary|ESA Dose|Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)|12 months|Intent-to-Treat Analysis, Missing Data Excluded||IU||Standard Deviation|Mean
127721|NCT00572533|Secondary|Mean Hb|Mean Hemoglobin concentration over follow-up period|12 months|Intent-To-Treat Analysis, Missing Data Excluded||g/dL||Standard Deviation|Mean
127722|NCT00572533|Secondary|Percent Hb > 12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.|12 months|Intent-To-Treat, Missed Data Excluded||Percent|||Number
127723|NCT00572533|Post-Hoc|Transfusion Events|Number of Transfusion Events|12 months|Intent-To-Treat, Missing Data Excluded||Events|||Number
127724|NCT00572533|Secondary|Percent Hb < 10 g/dL|Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded||Percent|||Number
127725|NCT00572533|Primary|Percent Hb 10-12 g/dL|Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.|12 months|Intent-To-Treat Analysis, Missing Data Excluded||Percent|||Number
127726|NCT00572260|Primary|Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision||30 days after surgery|The study closed due to the departure of the principal investigator and the data analysis was not performed.|||||
127727|NCT00572156|Secondary|Summary of Adverse Events With Number of Occurrences|A Data Monitoring Committee (DMC) was established to monitor subject safety|Approximately up to 4 years.|Safety population: Safety population consisted of all subjects who were randomized. Note that post baseline follow-up data were received for all subjects who were randomized.||Number of events|||Number
127728|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone Binding Protein (GHBP)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||pmol/L||Standard Deviation|Mean
127729|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Acid-Labile Subunit (ALS)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||mg/L||Standard Deviation|Mean
127730|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-3 (IGFPB-3)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
128266|NCT00566696|Secondary|Incidence of Regimen-related Mortality|The incidence of regimen-related mortality in the first 100 days post-transplant is estimated based on binomial distribution.|100 days post-transplant|||Percentage of participants|||Number
127731|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
127732|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Insulin-Like Growth Factor-1 (IGF-1)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
127733|NCT00572156|Secondary|Changes From Baseline (Day 1) in Serum Concentrations of Growth Hormone (GH)||At Baseline (Day 1), Year 1,2,3 and 4|Modified Intent-to-Treat (MITT) Population comprised all subjects who were randomized and had at least one post-baseline height measurement.||ng/mL||Standard Deviation|Mean
127734|NCT00572156|Secondary|Skeletal Maturation|"Assessed by bone age. Bone age was determined by the radiograph.~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline(day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).||SDS||Standard Deviation|Mean
127735|NCT00572156|Secondary|Total Change From Baseline (Day 1) in BMI SDS|"BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At year 1,2,3,4 and end of study (visit 23) versus baseline (day 1)|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).||SDS||Standard Deviation|Mean
127736|NCT00572156|Secondary|Predicted Adult Height (PAH)|"Predicted Adult Height calculated by method, Roche-Wainer-Thissen (RWT) and mid-parental target height SDS.~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|At baseline (Day 1), year 1,2,3 and 4|Completers, the completer population consists of all subjects that remained in the study until a specific time point (ie; Year 1, Year 2, Year 3 and Year 4).||SDS||Standard Deviation|Mean
127737|NCT00572156|Secondary|Cumulative Change in Height Standard Deviation Score (SDS)|"Height was measured standing and without shoes, and recorded as the mean of three measurements (the subject being repositioned each time) by the same observer using a Harpenden or other wall-mounted stadiometer which was to be calibrated prior to measurement of each subject and a calibration log kept.~The SDS was calculated as: SDS=[(value /M)^L – 1] / LS; using power (L), Mean (M) and coefficient of variation (S). The reference values were dependent on gender in addition to age and were selected at the age the closest below subject’s age. SDS scores were calculated using L, M and S as defined in the National Center for Health Statistics 2000 data as provided by the Center for Disease Control (Kuczmarski, Ogden et al. 2002)"|First, second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.||SDS||Standard Deviation|Mean
127738|NCT00572156|Secondary|Height Velocity||Second, third and fourth year|Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.||cm/y||Standard Deviation|Mean
127739|NCT00572156|Primary|Height Velocity||First year of treatment|"Modified Intent-To-Treat (MITT): MITT population comprised all subjects who were randomized and had at least one post-baseline height measurement.~[n= 25,27,27,26]"||cm/y||Standard Deviation|Mean
127740|NCT00572117|Secondary|Effect of Treatment on Mood Symptoms|The 17-item Hamilton Depression Rating Scale (HAM-D) is a standard measure of symptoms of depression with a scoring range of 0-53 points. Higher HAM-D scores represent more depression, so a lowering of HAM-D scores is considered a good outcome, an increase in HAM-D scores considered a worsening of outcomes.|Baseline and 12 weeks|||units on a scale||95% Confidence Interval|Mean
127741|NCT00572117|Primary|Amount of Alcohol Consumed|Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink.|Baseline and 12 weeks|||number of drinks per heavy drinking day||95% Confidence Interval|Mean
127742|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|6 months|105 PST and 110 ST participants provided data at 6 months.||units on a scale||Standard Deviation|Mean
127759|NCT00571662|Secondary|Toxicity|determination of regimen related toxicity of the combination of Pentostatin and low dose total body irradiation. Treatment related toxicity will be graded using NCI CTC Version 2.0 and GVHD using the standard GVHD grading system.|Duration of treatment||||||
127760|NCT00571662|Primary|Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting|the efficacy of the regimen as determined by engraftment rate and establishment of donor hematopoietic chimerism at day +28 and day +70.|days +28 and +70|||percent of participants||Full Range|Median
128285|NCT00566501|Secondary|Mean Change From Baseline in MMSE Score|The Mini-Mental State Examination (MMSE) is a brief, 30-item test of cognitive function.|12 months||||||
127743|NCT00572039|Primary|Targeted Vision Function|We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its “difficulty” (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.|6 months|105 PST and 110 ST participants provided data at 6 months.||units on a scale||Standard Deviation|Mean
127744|NCT00572039|Secondary|Vision-related Quality of Life|We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.|3-Months|106 PST and 112 ST participants provided data at 3 months.||units on a scale||Standard Deviation|Mean
127745|NCT00572039|Primary|Targeted Vision Function (TVF)|We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 [not important]to 4 [very important]), the subject rates its “difficulty” (on a scale of 0 [not difficult] to 4 [impossible]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.|3-Months|106 PST and 112 ST participants provided data at 3 months.||units on a scale||Standard Error|Mean
127746|NCT00571987|Secondary|Recurrence of Breast Cancer at Prior Site of Disease||Until study end (2 years)|During the 68-month median follow-up in patients not treated with XRT, there were 2 in-site tumor recurrences treated with AI, 3 biopsy entrance site recurrences treated with excision and XRT to conserve the breast, and 2 recurrences elsewhere and 1 contralateral recurrence; all 3 treated with mastectomy.||participants|||Number
127747|NCT00571987|Primary|Number of Patients Requiring 2nd Surgery for Close or Positive Margins|"A close surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a wide surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined close as less than 3 mm."|Margins assessed at Final Pathology, approximately 1 week post-RF surgery|||participants|||Number
127748|NCT00571974|Primary|The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).|The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size.|Day 90|The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall.||participants|||Number
127749|NCT00571974|Primary|Maximum Tolerated Dose|The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.|Day 2|Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures (laser doses) of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. The highest radiant light dose attained that did not produce more than 2 DLTs was declared to be the maximum tolerated dose (MTD).||J/cm2|||Number
127750|NCT00571961|Primary|Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)|Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period.|15 days|||(ng/mL)*hr||Standard Deviation|Mean
127751|NCT00571948|Primary|Parameters of Iron Status in Blood||at the end of the fourth, seventh, tenth month of life||||||
127752|NCT00571948|Secondary|Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences||dietary intake: from the beginning of the third month of life to the end of the tenth month; anthropometric measures: at the end of the fourth, seventh, tenth month||||||
127753|NCT00571948|Primary|Sum of Omega-3 Fatty Acid Pattern in Plasma|"fatty acids were measured in the whole plasma (in mg). They were transformed into percent (%) per total fatty acids.~Results are shown as percent (%) per total fatty acids before and after the intervention as median (percentile 25th;75th)."|at the end of the tenth month of life|||percent of total fatty acids||Inter-Quartile Range|Median
127754|NCT00571922|Secondary|Craving||7 day|PI passed away, data is unavailable|||||
127755|NCT00571922|Primary|Methamphetamine Abstinence||7 day|PI passed away, data is unavailable.|||||
127756|NCT00571662|Secondary|Responses to Therapy|event-free and overall survival at 12 months|every 6 mo. up to 2 years|||Percent of Participants|||Number
127757|NCT00571662|Secondary|Incidence of Acute and Chronic Graft-versus-host Disease|Incidence of acute and chronic graft-versus-host disease.Acute GVHD usually occurs during the first three months following transplant. Chronic GVHD usually develops after the third month post-transplant.|twice weekly until day 100 up to 1 year post transplant|||Percent of Particpants|||Number
127758|NCT00571662|Secondary|Immune Effects|kinetics of hematologic and immunologic reconstitution after allogeneic transplantation|pretransplant and post transplant days28,70,100 and 12, and 24 months||||||
128794|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
127761|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.|Up to Day 10 + 5 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
127762|NCT00571649|Secondary|Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)|Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding|Up to Day 35 + 6 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
127763|NCT00571649|Secondary|Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days|All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.|Up to Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
127764|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations||Percentage of participants|||Number
127765|NCT00571649|Secondary|Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days|The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35||Percentage of participants|||Number
127766|NCT00571649|Secondary|Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90|Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
127767|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events|Up to Day 10 + 5 days|Participants valid for safety analysis, with adequate assessment of VTE (to Day 10 within 48 hours of study drug), met inclusion criteria, and no major protocol deviations; expanded to include participants who had major bleeding or clinically relevant non-major bleeding events and met all criteria for PP except valid assessment of thromboembolism.||Percentage of participants|||Number
127768|NCT00571649|Secondary|Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days|Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants with major and clinically relevant bleeding events.||Percentage of participants|||Number
127769|NCT00571649|Secondary|Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90|Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90|At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days|Safety population: Participant had at least one dose of study drug.||Percentage of participants|||Number
127770|NCT00571649|Secondary|Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10) expanded to include participants who had an assessment of all deaths, including not VTE-related||Percentage of participants|||Number
127771|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|modified Intent-to-Treat (mITT) Day 10: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10||Percentage of participants|||Number
127786|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken between 12 and 24 hours of dosing.|12-24 hours|Intent to treat population||liters||Standard Deviation|Mean
127772|NCT00571649|Secondary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants who had an assessment of all deaths, including not VTE-related||Percentage of participants|||Number
127773|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 10 + 5 days|Per Protocol (PP) Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations.||Percentage of participants|||Number
127774|NCT00571649|Primary|Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days|A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.|Up to Day 35 + 6 days|modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35||Percentage of participants|||Number
127775|NCT00571428|Secondary|Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration. The measure compares the change from pre-dose reading to each post-dose time point.|immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population||liters||Standard Deviation|Mean
127776|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing|Forced vital capacity is the total amount of air that can forcibly be blown out after full inspiration.|pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose|Intent to treat population||minutes||Standard Deviation|Mean
127777|NCT00571428|Secondary|Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing|Time to a 12 percent improvement in forced expiratory volume in one second (FEV1) AND a 200 milliliter increase in FEV1 within 12 hours of dosing. Only patients who met both conditions are included|up to 12 hours post dose|Intent to treat population. Limited to patients who met both criteria: a 12 percent increase in FEV1 and a 200 milliliter increase in FEV1||minutes||Full Range|Median
127778|NCT00571428|Secondary|Time to Onset of 15 Percent Response Within 12 Hours of Dosing|Time to a 15 percent improvement in forced expiratory volume in one second (FEV1) within 12 hours of dosing. Only patients who achieved at least a 15 percent improvement are included.|12 hours post first dose|Intent to treat population. Limited to those patients who had a 15% response.||minutes||Full Range|Median
127779|NCT00571428|Secondary|Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 12 hours post-dose, and reports the largest change during that time.|12 hours|||liters||Standard Deviation|Mean
127780|NCT00571428|Secondary|Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose.|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function and reports the highest percent found within 12 hours of dosing.|12 hours|Intent to treat population||percent of predicted FEV1||Standard Deviation|Mean
127781|NCT00571428|Secondary|Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the change in percent of the estimated healthy lung function at specified time points compared to the pre-dose value.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population||percent of predicted FEV1||Standard Deviation|Mean
127782|NCT00571428|Secondary|Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose|Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. This outcome uses actual FEV1 readings to generate the percent of the estimated healthy lung function at specified time points.|Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population||Percent of Predicted FEV1||Standard Deviation|Mean
127783|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the change in FEV1 readings between pre-dose and various time points within 24 hours post-dose.|Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose|Intent to treat population||liters||Standard Deviation|Mean
127784|NCT00571428|Secondary|Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome offers the FEV1 readings taken pre-dose and at various time points within 24 hours post-dose.|pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose|Intent to treat population||liters||Standard Deviation|Mean
127785|NCT00571428|Secondary|Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change in FEV1 from pre-dose to the readings taken 24 hours post-dose, which represents the trough in dose level.|pre-dose and 24 hours post-dose|Intent to treat population||liters||Standard Deviation|Mean
127787|NCT00571428|Secondary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 12 hours of dosing.|0-12 hours|Intent to treat population||liters||Standard Deviation|Mean
127788|NCT00571428|Primary|Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours|Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.|0-24 hours post dose|Intent to treat population||liters||Standard Deviation|Mean
127789|NCT00571324|Secondary|Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma intact glucagon-like Peptide-1 (GLP-1) levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean intact GLP-1 area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||pmol*min/L||Standard Error|Mean
127790|NCT00571324|Secondary|Mean Plasma Glucagon Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma glucagon area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||pg*min/dL||Standard Error|Mean
127791|NCT00571324|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||pmol*min/L||Standard Error|Mean
127792|NCT00571324|Primary|Mean Blood Glucose Area Under the Curve (AUC 0-6h)|To examine the effect of Exendin-(9-39) on fasting blood glucose levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean blood glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared.|6 hours|Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle.||mmol*min/L||Standard Error|Mean
127793|NCT00571038|Secondary|Change in Patient Activation|"Mean/SE change in score on:~Scale: Hibbard Patient Activation Measure (PAM) Construct: Level of patient activation and engagement in health care Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127794|NCT00571038|Secondary|Change in Health Opinions|"Mean/SE change in overall score on:~Scale: Krantz Health Opinion Survey Construct: Opinions about healthcare and healthcare providers Minimum Score: 0 Maximum Score: 16 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127795|NCT00571038|Secondary|Change in Social Support|"Mean/SE change in overall score on:~Scale: Medical Outcomes Study (MOS) Social Support Survey Construct: Overall measure of social support, including tangible, affectionate, positive social interaction, and emotional/informational Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127796|NCT00571038|Secondary|Change in Self Efficacy|"Mean/SE change in score on:~Scale: Schwarzer General Perceived Self-Efficacy Construct: Perceived self-efficacy Minimum Score: 10 Maximum Score: 40 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127797|NCT00571038|Secondary|Change in Medication Adherence|"Mean/SE change in score on:~Scale: Morisky Adherence; questions modified to ask specifically about blood pressure medication Construct: Adherence to prescribed medication-taking regimen Minimum Score: 0 Maximum Score: 4 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127798|NCT00571038|Secondary|Change in Fruit and Vegetable Intake|Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||servings of fruits & vegetables per day||Standard Error|Mean
127799|NCT00571038|Secondary|Change in Daily Steps|Mean/SE change in # of steps per day (self report)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||steps per day||Standard Error|Mean
127995|NCT00569777|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127800|NCT00571038|Secondary|Change in Physical Activity Level|"Mean/SE change in score on:~Scale: International Physical Activity Questionnaire (IPAQ), Metabolic Equivalent of Task (MET) Construct: Total metabolic equivalents (a measure of energy expenditure) in the last 7 days Minimum Score: 0 Maximum Score: Not applicable; based on physical activity done Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||METS||Standard Error|Mean
127801|NCT00571038|Secondary|Change in Sodium Intake|"Mean/SE change in score on:~Scale: Hopkins Dietary Questionnaire (only the dietary salt avoidance questions) Construct: Dietary sodium intake Minimum Score: 2 Maximum Score: 12 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127802|NCT00571038|Secondary|Change in Alcohol Use|"Mean/SE change in score on:~Scale: Alcohol Use Disorders Identification Test (AUDIT) Construct: Alcohol use and abuse Minimum Score: 0 Maximum Score: 12 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127803|NCT00571038|Secondary|Change in Satisfaction With Blood Pressure Treatment|"Mean/SE change in score on:~Scale: Modified Holmes-Ravnor Satisfaction with Decision (SWD) Construct: Satisfaction with current blood pressure treatment Minimum Score: 1 Maximum Score: 5 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127804|NCT00571038|Secondary|Change in Hypertension Attitudes|"Mean/SE change in score on:~Scale: Not applicable; series of agree/disagree statements that we wrote Construct: Attitudes around blood pressure diagnosis, treatment (including lifestyle changes), and seriousness of the condition Minimum Score: 12 Maximum Score: 60 Interpretation of Score: Lower is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127805|NCT00571038|Secondary|Change in Hypertension Knowledge|"Mean/SE change in score on:~Scale: Hypertension Evaluation of Lifestyle and Management (HELM) Construct: Knowledge of hypertension and lifestyle factors related to hypertension Minimum Score: 0 Maximum Score: 14 Interpretation of Score: Higher is better"|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||survey score||Standard Error|Mean
127806|NCT00571038|Secondary|Change in Number of Blood Pressure Medications|Change in mean # of prescription blood pressure medications|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||blood pressure medications||Standard Error|Mean
127807|NCT00571038|Secondary|Non-Clinic Blood Pressure Checks|% reporting non-clinic blood pressure (BP) checks at least once a month|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||percentage of participants|||Number
127808|NCT00571038|Secondary|Change in Time Since Last Physician Visit|Change in mean # of months since last visit to a physician|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||months (since last visit)||Standard Error|Mean
127809|NCT00571038|Secondary|Change in Health Status|"Response to the question How would you rate your general health status?. Response options are scored as follows.~Excellent~Very Good~Good~Fair~Poor We report the change in health status from baseline to 12 months."|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||units on a scale (range 1-5)||Standard Error|Mean
127810|NCT00571038|Secondary|Change in BMI|Mean/SE change in Body Mass Index (BMI) (kg/m2)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||kg/m2||Standard Error|Mean
127811|NCT00571038|Secondary|Change in Weight|Mean/SE change in weight, measured in pounds (lbs)|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||pounds||Standard Error|Mean
127812|NCT00571038|Secondary|Change in Diastolic Blood Pressure|Mean/SE change in diastolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||mm Hg||Standard Error|Mean
127813|NCT00571038|Primary|Change in Systolic Blood Pressure|Mean/Standard Error (SE) change in systolic blood pressure|9/16/2008-8/9/2010; baseline and 12 months|Consented, hypertensive members of participating veterans service organizations in SE Wisconsin.||mm Hg||Standard Error|Mean
127814|NCT00570960|Primary|30 Day All Cause Mortality|30 day all cause mortality|30 days|||participants|||Number
127815|NCT00570921|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as a complete response, partial response, or stable disease (CR, PR, SD) by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks or more.|Duration of response or stable disease for 24 weeks or more|||participants|||Number
127816|NCT00570921|Secondary|Objective Response Rates|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Evaluated 60 days after therapy start|||participants|||Number
127817|NCT00570921|Primary|Time to Progression||Duration of time start of treatment to time of documented progression or death|||months||95% Confidence Interval|Median
127818|NCT00570908|Primary|Progression Free Survival|Progression free survival is defined as form initiation of WBRT with capecitabine to the time of first documented progression at any site (CNS or non-CNS site) or death due to any cause, where progression is defined stringently by progression in either CNS or extra-CNS metastases.|2 years|5 patients progressed during the study treatment. 7 patients were off study treatment early due to AE or withdrawal but 6 of them were followed for the survival outcome, 1 was lost to follow up after 3.5 months observation (censored data).||months||95% Confidence Interval|Median
127819|NCT00570778|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events|Additional information about adverse events can be found in the Adverse Event Section.|47 days|Safety population includes all participants who received at least 1 dose of study drug.||Participants|||Number
127820|NCT00570778|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.|Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.||Liters||Standard Error|Least Squares Mean
127821|NCT00570778|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.|Baseline, Day 7|Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.||Liters||Standard Error|Least Squares Mean
127822|NCT00570765|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 weeks||||||
127823|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: ALT|Percent change of alanine transaminase(ALT)from Baseline (Day 0) vs. Day 85/ or early termination.|Baeline and 12 weeks|||Percent change||Standard Error|Mean
127824|NCT00570765|Secondary|Hepatocellular Injury and Liver Function: GGT|Percent change of gamma-glutamyl transferase (GGT)from Baseline (Day 0) vs. Day 85/ or early termination (ET) visit.|Baeline and 12 weeks|||Percent change||Standard Error|Mean
127825|NCT00570765|Primary|Alkaline Phosphatase (AP) Levels|Percent (%) Change in Serum Alkaline Phosphatase from baseline to end of study (EOS)at Day 85.|Baseline and 12 weeks|Per Statistical Analysis Plan (SAP): patients will be analyzed by the treatment group to which they were randomly assigned - intention to treat (ITT) principle.||Percent change||Standard Error|Mean
127826|NCT00570739|Secondary|Percent of Subjects Meeting Type 2 Diabetes Criteria (Fasting Plasma Glucose >or= to 126 mg/dL or Plasma Glucose >or= to 200 mg/dL Post 2 Hr Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127827|NCT00570739|Secondary|Percent Achievement of Hs-C-Reactive Protein <2.0 mg/L in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 2.0 mg/L From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127828|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose Post 2 Hour Glucose Tolerance Test and Fasting Plasma Glucose <110 mg/dL in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127829|NCT00570739|Secondary|Percent Achievement of <100 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 100 mg/dL From Baseline to 4, 8, 12 and 16 Weeks||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127830|NCT00570739|Secondary|Percent Achievement of <110 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 110 mg/dL From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF||Percent of participants|||Number
127831|NCT00570739|Secondary|Percent Achievement of <140 mg/dL Plasma Glucose 2 Hours Post the Oral Glucose Tolerance Test in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was >or= to 140 mg/dL From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127832|NCT00570739|Secondary|Area Under the Curve for Plasma Glucose From 0 to 120 Minutes During the Oral Glucose Tolerance Tests in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL*hr||Standard Error|Least Squares Mean
127833|NCT00570739|Secondary|Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Change in Ratio||Standard Error|Least Squares Mean
127834|NCT00570739|Secondary|Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||lb||Standard Error|Least Squares Mean
127835|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127836|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127837|NCT00570739|Secondary|Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||ng/mL||Standard Error|Least Squares Mean
127838|NCT00570739|Secondary|Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||uIU/mL||Standard Error|Least Squares Mean
127839|NCT00570739|Secondary|Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127840|NCT00570739|Secondary|Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127841|NCT00570739|Secondary|Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127842|NCT00570739|Secondary|Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|||ng/mL||Standard Error|Least Squares Mean
127843|NCT00570739|Secondary|Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127844|NCT00570739|Secondary|Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127845|NCT00570739|Secondary|Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127846|NCT00570739|Secondary|Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127847|NCT00570739|Secondary|Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||nm||Standard Error|Least Squares Mean
127848|NCT00570739|Secondary|Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. These 16 week analyses are both LOCF and no LOCF.||nmol/L||Standard Error|Least Squares Mean
127849|NCT00570739|Secondary|Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Inter-Quartile Range|Median
127850|NCT00570739|Secondary|Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Inter-Quartile Range|Median
127851|NCT00570739|Secondary|Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127852|NCT00570739|Secondary|Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127853|NCT00570739|Secondary|Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127854|NCT00570739|Secondary|Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127855|NCT00570739|Secondary|Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127856|NCT00570739|Secondary|Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127857|NCT00570739|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables.||Percentage of change||Standard Error|Least Squares Mean
127858|NCT00570739|Secondary|Percent of Subjects Achieving Hs-C-Reactive Protein Goal of <2.0 mg/L When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127859|NCT00570739|Secondary|Percent of Subjects Achieving 2-Hr. Post Meal Glucose Goal of <180 mg/dL When Given to Drug-naïve, Diabetic Subjects From Baseline to Week 16||Baseline to Week 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127860|NCT00570739|Secondary|Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change|||Number
127996|NCT00569777|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127861|NCT00570739|Secondary|Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT||Baseline vs. 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL*hr||Standard Error|Least Squares Mean
127862|NCT00570739|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Last Observation Carried Forward was used for 16 week analyses.||Percentage of change in LDL-C||Standard Error|Least Squares Mean
127863|NCT00570739|Secondary|Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Ratio||Standard Error|Least Squares Mean
127864|NCT00570739|Secondary|Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||lb||Standard Error|Least Squares Mean
127865|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127866|NCT00570739|Secondary|Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to Weeks 8, and 16|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127867|NCT00570739|Secondary|Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects||Baseline to 4, 8, 12 and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of particpants|||Number
127868|NCT00570739|Secondary|Percent of Subjects Achieving HbA1c Goal of <7.0% at Weeks 4, 8, 12, and 16 if Baseline HbA1c Was > or = to 7.0% When Given to Drug-naïve, Diabetics||Baseline to 4, 8, 12, and 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percent of participants|||Number
127869|NCT00570739|Primary|Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.||Baseline to 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was used.||Percentage of change of hemoglobin A1C||Standard Error|Least Squares Mean
127870|NCT00570739|Secondary|Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127871|NCT00570739|Secondary|Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks|These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.|Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127872|NCT00570739|Secondary|Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127873|NCT00570739|Secondary|Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 Weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||nm||Standard Error|Least Squares Mean
127874|NCT00570739|Secondary|Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||nmol/L||Standard Error|Least Squares Mean
127875|NCT00570739|Secondary|Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change in Apo C3||Standard Error|Least Squares Mean
127876|NCT00570739|Secondary|Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change in Apo B||Standard Error|Least Squares Mean
127877|NCT00570739|Secondary|Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change in Apo A-1||Standard Error|Least Squares Mean
127878|NCT00570739|Secondary|Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change of TG||Inter-Quartile Range|Median
127879|NCT00570739|Secondary|Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change of TC||Standard Error|Least Squares Mean
127880|NCT00570739|Secondary|Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||Percentage of change||Standard Error|Least Squares Mean
127881|NCT00570739|Secondary|Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||percentage of change in non-HDL||Standard Error|Least Squares Mean
127882|NCT00570739|Secondary|The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks||Baseline to 8, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||percentage of change in LDL-C||Standard Error|Least Squares Mean
127883|NCT00570739|Secondary|2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||ng/mL||Standard Error|Least Squares Mean
127884|NCT00570739|Secondary|2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||uIU/mL||Standard Error|Least Squares Mean
127885|NCT00570739|Secondary|2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127886|NCT00570739|Secondary|1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127887|NCT00570739|Secondary|30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127888|NCT00570739|Secondary|Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks||Baseline to 16 weeks|The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF.||ng/mL||Standard Error|Least Squares Mean
127889|NCT00570739|Secondary|Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||uIU/mL||Standard Error|Least Squares Mean
127890|NCT00570739|Secondary|Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks||Baseline to 4, 8, 12, and 16 weeks|The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF.||mg/dL||Standard Error|Least Squares Mean
127891|NCT00570739|Secondary|Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks.||Baseline to 4, 8, 12, and 16 weeks|The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was not used.||Percentage of change in HbA1c||Standard Error|Least Squares Mean
127892|NCT00570713|Secondary|Best Overall Response Rate|Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.|Baseline to response up to 21 months|||percentage of participants|||Number
127893|NCT00570713|Secondary|Progression-free Survival|Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.|1-21 Months|||Months||95% Confidence Interval|Median
127894|NCT00570713|Primary|Overall Survival (OS)|This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.|1-21 Months|||Months||95% Confidence Interval|Median
127895|NCT00570687|Primary|EGP AOC0-480 - Meal Challenge|EGP area over the curve from 0 to 480 minutes postdose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes. All subjects crossed over to lispro treatment. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; AOC could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.||µmol/kg||Standard Deviation|Mean
127896|NCT00570687|Primary|Minimum EGP - Meal Challenge|Minimum calculated EGP per subject as change from baseline|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.||µmol/kg/min||Standard Deviation|Mean
127897|NCT00570687|Primary|Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge|Time to minimum EGP post dose|0-480 minutes|Amendment 1: Subjects with type 2 diabetes; all received TI and were crossed over to lispro; 3 subjects in the 90 U TI group had insufficient data. Original protocol:Subjects with type 2 diabetes; all subjects received all doses; EGPmin could not be calculated for 1 subject for Exubera and 2 subjects for the other treatments.||Minutes||Full Range|Median
127898|NCT00570674|Secondary|2-Year Overall Survival [Phase I]|2-year overall survival is the proportion of patients alive at 2-years from study entry.|All patients were followed for survival for a minimum of 2 years. Median survival follow-up was 44.7 months (range 10-70) in this study cohort.|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
127899|NCT00570674|Secondary|Overall Response Rate [Phase I]|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|The primary re-staging assessment for response occurred 8-10 weeks following completion of treatment. Treatment duration was a mean (range) of 7.8 weeks (6.6-10.1).|The analysis dataset is comprised of all treated patients.||proportion of participants||95% Confidence Interval|Number
127900|NCT00570674|Primary|2-Year Disease-Free Survival [Phase II]|Disease-free survival (DFS) is defined as the time from registration to the earlier of disease recurrence or death from any cause. Patients alive without a recurrence are censored at the date of last disease evaluation. 2-year disease-free survival is the probability of patients remaining alive and progression-free at 2-years from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target.|Disease assessments occurred 8-10 weeks following treatment end then every 4-6 weeks (yr 1), every 8-10 weeks (yr 2), quarterly (yr 3) and semiannually up to 2 yrs since last pt enrolled.|The phase II portion planned to enroll 34 participants including the phase I expansion cohort but the study did not continue beyond phase I.|||||
127901|NCT00570674|Primary|Dose Limiting Toxicity (DLT) [Phase I]|Dose limiting toxicities (DLT) were defined as treatment-related: 1) grade 3-4 non-hematological toxicity excluding untreated nausea, vomiting and diarrhea; dysphagia, esophagitis, mucositis/stomatitis, dermatitis/rash, 2) Grade 3 or greater febrile neutropenia occurring during chemoradiotherapy, 3) Grade 4 neutropenia lasting >/= 7 days and 4) Grade 3 thrombocytopenia. Grade 4 toxicities resulting in a treatment breaks > 7 days were considered DLTs.|Adverse event assessments occurred weekly on treatment; The observation period for DLT evaluation incorporated the 7 weeks of treatment.|The analysis dataset is comprised of all treated patients in the dose escalation cohorts.While no DLTs were observed in the first 3 DL 1 patients, the cohort was expanded to 6 patients due to safety and tolerability concerns. Upon further review, it was resolved that the Abraxane dose should not be increased in the setting of concurrent Erbitux.||Participants with DLT|||Number
127902|NCT00570674|Primary|Abraxane Maximum Tolerated Dose (MTD) [Phase I]|The Abraxane MTD in combination with carboplatin and concurrent IMRT is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of participants experience a DLT. If no DLTs are observed then the MTD is not reached but the highest dose may then be the recommended phase II dose.|Adverse event assessments occurred weekly on treatment; The observation period for MTD evaluation incorporated the 7 weeks of treatment.|The MTD was not reached on this trial but the recommended phase II dose was the highest dose of Abraxane evaluated.||mg weekly|||Number
127903|NCT00570531|Secondary|The Proportion of Toxicities Experienced by Participants|To assess the toxicity of this regimen.|Every three weeks for one year|The study was unable to accrue the number of patients necessary to analyze the objective.|||||
127904|NCT00570531|Secondary|The Number of Patients Cancer Free at the Time of Surgery|Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery.|1 year|The study was unable to accrue the number of patients necessary to analyze the objective.|||||
127905|NCT00570531|Primary|Disease Free Survival Time|The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.|5 years|The study was unable to accrue the number of patients necessary to analyze the primary objective.|||||
127906|NCT00570505|Post-Hoc|Change in Quality of Life (5 Years)|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 5 years in IWQOL-Lite Total Score is reported.|5 years|Intent-to-treat (ITT)||units on a scale||Standard Deviation|Mean
127907|NCT00570505|Post-Hoc|Change in Obesity Related Comorbid Conditions (5 Years)|Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved 5 years post LAP-BAND implantation. Diabetes resolution was defined as HbA1c ≤ 6% and no diabetes medication usage. Dyslipidemia resolution was defined as HDL ≥ 60 mg/dL, LDL < 100 mg/dL, triglycerides < 150 mg/dL, and total cholesterol < 200 mg/dL. Hypertension resolution was defined as systolic blood pressure < 140 mm Hg.|5 years|Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49)||percentage of subjects|||Number
127908|NCT00570505|Post-Hoc|Subject Percent Excess Weight Loss (5 Years)|The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)*100.|5 years|Intent-to-treat (ITT)||percentage of excess weight loss||Standard Deviation|Mean
127909|NCT00570505|Post-Hoc|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation|The percent of subjects who attained clinically successful weight loss (ie, ≥ 30% Excess Weight Loss) at year 5 post LAP-BAND implantation. Percent EWL =(weight loss divided by excess weight)*100. Excess Weight was defined as Baseline Weight - Ideal Weight, where Ideal Weight was a BMI of 25 kg/m2.|5 years|Intent-to-treat (ITT)||percentage of subjects||95% Confidence Interval|Number
127910|NCT00570505|Secondary|Change in Quality of Life|Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported.|12 months|Intent-to-treat (ITT)||units on a scale||Standard Deviation|Mean
127911|NCT00570505|Secondary|Change in Comorbid Conditions Related to Obesity|"Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as none on a severity scale of none, mild, moderate, or severe) 12 months after implantation."|12 months|Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27)||percentage of subjects|||Number
127912|NCT00570505|Secondary|Percent Weight Loss|Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.|Baseline through 12 months|Intent-to-treat (ITT)||percentage of weight loss||Standard Deviation|Mean
127913|NCT00570505|Primary|Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation|The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.|One year|Intent-to-treat (ITT)||percentage of subjects|||Number
127914|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Appearance (App.)/Clarity and Color|Participants were assessed for their urine appearance, which was categorized as clear (normal), cloudy (presence of crystals, blood cells, or bacteria), of turbid. Also, participants were categorized by the color of urine: straw, yellow (normal urine), and dark yellow (DY) (which may be the result of bile in the urine).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
127915|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Occult Blood (OB) and the Urine Leukocyte Esterase Test (LET)|Occult blood (OB) is blood that cannot be seen without a microscope. Normal urine does not contain any red blood cells. Leukocyte esterase is an enzyme and is not found in normal urine. In the dipstick (qualitative) test, the level of OB and leukocyte esterase in urine samples was recorded as negative (Neg), small, moderate, large, trace, 1+ (slightly positive), 2+ (positive), and 3+ (high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of OB and urine leukocyte esterase.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
127916|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Glucose, Urine Ketones, and Urine Proteins|Urine glucose, urine ketones, and urine proteins were measured in participants using a dipstick (qualitative) test at the indicated time points. In this dipstick test, the level of glucose, ketones, and protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Participants were categorized as negative or positive based on the absence or presence, respectively, of glucose, ketones, and proteins in the urine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
127917|NCT00570492|Secondary|Number of Participants With the Indicated Urinalysis Results for Urine Bilirubin and Urine Nitrite|Bilirubin is a normal body by-product (bile), and nitrite is a by-product of bacterial growth. Participants were categorized as Negative (Neg.) or Positive (Pos.) based on the absence or presence, respectively, of urine bilirubin (UB) and urine nitrate.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||participants|||Number
127918|NCT00570492|Secondary|Mean Values for Urine Specific Gravity|Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||ratio||Standard Deviation|Mean
127919|NCT00570492|Secondary|Mean Values for Urine pH|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||scores on a scale||Standard Deviation|Mean
127920|NCT00570492|Secondary|Mean Hematology Values for Red Blood Cells (RBCs)|RBCs was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Trillion (10^12) cells (Ti)/L||Standard Deviation|Mean
127921|NCT00570492|Secondary|Mean Values for Hematocrit|Hematocrit was assessed in participants at indicated the time points. Hematocrit is the percentage of blood volume (BV) that is occupied by red blood cells (RBCs).|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Percentage of BV occupied by RBCs||Standard Deviation|Mean
127922|NCT00570492|Secondary|Mean Values for Hemoglobin|Hemoglobin was assessed in participants at the indicated time points.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||g/L||Standard Deviation|Mean
127923|NCT00570492|Secondary|Mean Hematology Values for Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet Counts|Participants in the study were evaluated for the following hematology laboratory parameters at the indicated time points: Basophil, Eosinophil, Lymphocyte, White Blood Cell (WBC), Monocyte, Segmented Neutrophil (Neu), and Platelet counts.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Giga (10^9) cells (Gi)/L||Standard Deviation|Mean
127924|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Glucose, Calcium, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Glucose, Calcium, Potassium, Sodium, and Urea/BUN.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Millimoles (mmol)/L||Standard Deviation|Mean
127997|NCT00569777|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127925|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Total Bilirubin and Creatinine|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Total Bilirubin and Creatinine.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Micromoles (µmol)/L||Standard Deviation|Mean
127926|NCT00570492|Secondary|Mean Values for the Laboratory Parameters if Albumin and Total Protein|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Albumin and Total Protein.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||Grams per liter (g/L)||Standard Deviation|Mean
127927|NCT00570492|Secondary|Mean Values for the Laboratory Parameters of Alkaline (Alk) Phosphatase (P), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)|Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: Alk P, ALT, and AST.|Baseline Period (Weeks -16 to 0), DB Treatment Period (Weeks 1 to 52), and Follow-up Period (Weeks 53 to 60)|ITT Population. Only those participants remaining in the study and contributing viable samples at the various time points were analyzed.||International Units per liter (IU/L)||Standard Deviation|Mean
127928|NCT00570492|Secondary|Number of Participants With the Indicated Shifts From Baseline in Nasal Examination (NE) Results|NE included the evaluation of the size of ulcers/polyps (of nasal turbinates/septa) and assessment for mucosal bleeding (MB) at all study visits. Polyps are non-cancerous growths; ulcers are breaks in the skin/mucous membrane with loss of surface tissue, disintegration, and necrosis of epithelial tissue. For MB, Improved=shift from present (>=1 nostril) to absent (both nostrils); Worsened=shift from absent (both nostrils) to present (>=1 nostril). For polyps/ulcers, Improved=shift from large to small or from small to none; Worsened=shift from none to small or from small to none (>=1 nostril).|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of double-blind study medication. Most participants received examinations at each visit; however, on some occasions, some assessments were not completed for various reasons.||participants|||Number
127929|NCT00570492|Secondary|Mean 24-hour Urinary Free Cortisol Excretion|Hypothalamic-pitiutary-adrenal (HPA) axis function was assessed by the measurement of urinary free cortisol, using urine samples collected over the course of 24 hours by the parent/guardian in the participants' home on an out-patient basis within 7 days prior to the indicated time points. Detailed verbal instructions and a take-home instruction card on how to conduct the 24-hour urine collection were provided to the parent/guardian before each collection interval.|Randomization/end of 16-week Baseline Period (Week 0), End of 52-week DB Treatment Period (Week 52), and end of 8-week Follow-up Period (Week 60)|Urine Cortisol Population: all randomized participants excluding those whose urine samples were considered to have confounding factors affecting the interpretation of the 24-hour urinary cortisol results. One participant in each arm had a Baseline value <1.0 and was not analyzed. Some participants had samples that were not acceptable for analysis.||Micrograms per 24 hours (mcg/24 hours)||Standard Deviation|Mean
127930|NCT00570492|Primary|Change From Baseline in the Growth Velocity of Pre-pubescent Pediatric Participants to the End of the 52-week Double-blind (DB) Treatment Period|Height was measured (triplicate measurements) in pre-pubescent pediatric participants via stadiometry at each clinic visit during the entire 76-week study period (16-week Baseline Period, 52-week DB Treatment Period and 8-week Follow-up Period). Growth velocity was calculated by fitting a regression line to all height measurements recorded for the participant during the period and was determined by the slope of the fitted regression line. Change from Baseline was calculated as the value over the 52-week Treatment Period minus the value over the 16-week Baseline Period.|Baseline Period (Weeks -16 to 0) and DB Treatment Period (Weeks 1 to 52)|Growth Population: all randomized participants with height assessments via stadiometry from at least three post-randomization clinic visits during the DB Treatment Period||Centimeters per year (cm/year)||Standard Error|Least Squares Mean
127931|NCT00570401|Primary|Determine the Overall Objective Response|To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.|2 years|||participants|||Number
127932|NCT00570362|Primary|Total Glutathione Levels|Subjects were instructed to fast from midnight to 8 AM on the morning of the test. All blood samples were obtained by a qualified registered nurse in the morning, between 8 and 10 AM.|Once in the morning.|||nmol||Standard Deviation|Mean
127933|NCT00570349|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Decrease in forced expiratory volume in 1 second was measured through spirometer. Spirometer measures the volume of air inspired and expired by the lungs.|Baseline and 48 hours|||Liters||Standard Deviation|Mean
127934|NCT00570349|Primary|Change in Oxygen Saturation|"Safety and tolerability of drug assessed by decreased oxygen saturation was measured through pulse oximeter, which measure the amount of oxygen in the blood.~Normal range percentage is 95 - 100%"|Baseline and 48 hours|||Percent of oxygen saturation||Standard Deviation|Mean
127935|NCT00570349|Secondary|Assess the Difference in Sputum Bacterial Density Before and After NO Inhalation. Assess the Difference in Lower Airway Inflammatory Measures Before and After NO Inhalation||44 hours||||||
127936|NCT00570349|Primary|Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels|Methemoglobin level assessments were measured through blood draws - hematology. This test measures the amount of methemoglobin (a type of hemoglobin that is unable to transport oxygen to tissues) in blood. Normal methemoglobin percentage range 1% - 2%.|Baseline and 48 hours|||Percent of Methemoglobin Level||Standard Deviation|Mean
127937|NCT00570310|Secondary|'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study|Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)|6 Weeks|Primary Responders: ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.||Days||Full Range|Least Squares Mean
127938|NCT00570310|Primary|Daily Evening Patient Reported Pain Intensity Scores|Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)|Baseline and 6 Weeks|Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.||Units on a Scale||Full Range|Least Squares Mean
127939|NCT00570232|Secondary|Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.|Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy|12 - 24 months|||percentage of participants|||Number
127940|NCT00570232|Primary|Percentage of Participants With Disease Free Status at 12 Months and 24 Months|Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)|12 - 24 months|||percentage of participants|||Number
127941|NCT00570232|Primary|Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|12 - 24 months|||participants|||Number
127942|NCT00570141|Primary|Percent Wounds Closed|"Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.~The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU)."|baseline and 12 weeks|Analysis was Per Protocol||Percent of Wounds Closed|||Number
127943|NCT00570141|Primary|Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.|"Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.~The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment.~Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)"|Baseline and weekly up to 12 weeks|Analysis was Per Protocol||cm2||Standard Deviation|Mean
127944|NCT00570089|Secondary|Seattle Angina Questionnaire (SAQ)|"Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period.~The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.~Each final SAQ domain ranges from 0-100, where higher is a better outcome score. Subscales are not combined. Median, SD and range are calculated for each domain."|4 weeks and 10 weeks|||units on a scale||Full Range|Median
127945|NCT00570089|Primary|Cardiac Magnetic Resonance (CMRs)|Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 4th week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion defect in percentage.|4 weeks and 10 weeks|||Percentage of ischemic myocardium||Full Range|Median
127946|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns|The percent of all household contacts of newborns who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum|||Percentage of All Household Contacts|||Number
127947|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Fathers of Newborns|The percent of new fathers who as reported by new mothers received an influenza vaccine during the mothers pregnancy, in the hospital after delivery, or during the 6 to 8 week period following the birth of their baby|Pregnancy period through 6 to 8 weeks postpartum|||Percentage of Fathers of Newborns|||Number
127948|NCT00570037|Primary|Influenza Vaccine Coverage (Percent) for New Mothers of Newborns|The percent of new mothers delivering at the hospital who reported receiving an influenza vaccine during their pregnancy, in the hospital after delivery, or during the 6 to 8 week postpartum period|Pregnancy period through 6 to 8 weeks postpartum|||Percentage of Participants|||Number
127949|NCT00569946|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria (CTCAE) for Adverse Events Version 3.0 Grade 3 or higher , serious adverse events, or adverse events resulted in discontinuation.|Up to 1709 days of treatment plus 28-days follow-up|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
127950|NCT00569946|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
127951|NCT00569946|Secondary|Plasma Concentration of Soluble Stem Cell Factor Receptor (s-KIT)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
127952|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (s-VEGFR3)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
127953|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (s-VEGFR2)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
128795|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
127954|NCT00569946|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 1 (s-VEGFR1)||Cycle 1 Day 1 predose, Day 1 of Cycle 2 to Cycle 7, and end of treatment/discontinuation (assessed up to 1709 days)|Biomarker analysis set included all participants enrolled in the study who received at least 1 dose of study medication and who submitted at least 1 sample; n=number of participants assessed.||pg/mL||Full Range|Median
127955|NCT00569946|Secondary|Number of Participants Analyzed for Population Pharmacokinetics of AG-013736|Population pharmacokinetic analysis of AG-013736 is conducted by combining current study data with other AG-013736 studies.|Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose|No population pharmacokinetic analysis results are available just for the current study.|||||
127956|NCT00569946|Secondary|Overall Survival (OS)|"OS was defined as the time from date of first dose of AG-013736 to date of death due to any cause.~Subjects in whom death is not reported will have their event time censored on the last date the subject is known to be alive."|Up to 2002 days (maximum duration of treatment plus follow-up observation)|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
127957|NCT00569946|Secondary|Duration of Response|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication. DR was calculated for the subgroup of participants with a confirmed objective tumor response. n=number of participants assessed as CR or PR.||months||95% Confidence Interval|Median
127958|NCT00569946|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
127959|NCT00569946|Secondary|Progression-Free Survival (PFS)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Up to 1709 days of treatment|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
127960|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
127961|NCT00569946|Primary|Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.|Up to 765 days of treatment at the data cut-off date|The Intent-To-Treat (ITT) population included all participants enrolled in the study who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
127962|NCT00569868|Primary|Antithrombotic Effect of VELCADE in a Malignancy Associated With a Hypercoagulable State in Patients With Relapsed/Refractory Multiple Myeloma.|"Goal is to evaluate changes in coagulation (blood clotting) in refractory/relapsing multiple myeloma patients during VELCADE treatment.~Before and during treatment, participant will undergo routine tests/procedures following the Myeloma Institute’s guidelines (physical exams, blood, urine, and bone tests, and bone marrow aspirates and biopsies) and will also receive a series of coagulation tests before treatment and after 1st and 3rd doses of each cycle.~Response measured as: complete, partial, or minimal response, no change, progressive disease, or relapse from complete response."|60 days|no analysis done, descriptive information on the magnitude, direction, and variability of changes in coagulation factors and platelet function in refractory/relapsing multiple myeloma patients during VELCADE treatment was collected||participants|||Number
127963|NCT00569855|Primary|Number of Participants Who Had Significant Hypotension as Defined in the Protocol as Need for Norepinephrine Dose >0.1mcq/kg/Min in the First 72 Hours Postoperatively|Number of subjects who required Norepinephrine >0.1mcq/kg/min|72 hours postoperatively|No. of subjects consented = 832; 785 subjects received study drug||participants|||Number
127964|NCT00569803|Secondary|Number of Participants With Positive Immunogenicity to Belatacept|The number of participants with positive immunogenicity to Belatacept was reported for each arm. Positive immunogenicity was defined as the presence of a positive antibody response generated against Belatacept.|Days 1, 14, 28, 42, 56, 86, 116|All participants treated with Belatacept||participants|||Number
127998|NCT00569777|Primary|Conjunctival Redness, Change From Baseline|Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127965|NCT00569803|Secondary|Number of Participants With Marked Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Glucose (mg/dL): <0.8*LLN, >1.5*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN).~Protein (grams per deciliter: g/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).~Albumin (g/dL): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mg.dL): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)"|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
127966|NCT00569803|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).~Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx).~Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (mg/dL): >1.33*Pre-Rx. Sodium (milliequivalents per Liter: mEq/L): <0.95*LLN, >1.05*ULN (if Pre-Rx<LLN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN).~Potassium(mEq/L), Chloride (mEq/L), Calcium(mg/dL): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN).~Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN)."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
127967|NCT00569803|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|"LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities:~Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (*10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx).~Leukocytes (*10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre-Rx>ULN, use >1.15*Pre-Rx or <LLN) Neutrophils+Bands (*10^3 c/uL): <=1.500. Lymphocytes (*10^3 c/uL): <0.750 or >7.500. Monocytes (*10^3 c/uL): >2.000. Basophils (*10^3 c/uL): >0.400. Eosinophils (*10^3 c/uL): >0.750."|Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
127968|NCT00569803|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants underwent a 12-lead ECG assessment at Screening (Day 1) and Study Discharge (Day 116). All investigator-assessed ECG abnormalities were reported.|Days 1 and 116|All treated participants||participants|||Number
127969|NCT00569803|Secondary|Number of Participants With Physical Examination Abnormalities|All clinically significant deviations from normal physical examinations were reported.|Days 1, 2, 5, 14, 28, 42, 86, 116|All treated participants||participants|||Number
127970|NCT00569803|Secondary|Number of Participants With Injection Site Reactions|Participants were assessed for erythema, heat, pain, pruritis and swelling at the injection sites and were characterized by the investigator as mild, moderate or severe reactions.|0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116|All treated participants||participants|||Number
127971|NCT00569803|Secondary|Number of Participants With Vital Sign Abnormalities|Vital signs (body temperature, respiratory rate, seated blood pressure, and heart rate) were recorded at screening. All significant findings were evaluated by the investigator, and all abnormalities were listed.|1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116|All treated participants||participants|||Number
127972|NCT00569803|Secondary|Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption|"AUC(0-T) and AUC(INF) for Belatacept were derived from serum concentration versus time data to assess the effect of number of injection sites on the subcutaneous absorption of Belatacept. All treatments were dose-normalized to 50mg. Adjusted geometric means reported in microgram hours per milliliter (ug*h/mL).~AUC(0-T) = Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration.~AUC(INF) = Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time."|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug*h/mL||90% Confidence Interval|Geometric Mean
127973|NCT00569803|Primary|Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept|Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept||Liters||Geometric Coefficient of Variation|Geometric Mean
127974|NCT00569803|Primary|Volume of Distribution at Steady State (VSS) for IV Belatacept|Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept||Liters||Standard Deviation|Mean
127975|NCT00569803|Primary|Total Body Clearance (CLT) of IV Belatacept|Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with IV Belatacept||mL/h||Geometric Coefficient of Variation|Geometric Mean
127976|NCT00569803|Primary|Apparent Total Body Clearance (CLT/F) of SC Belatacept|Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with SC Belatacept||mL/h||Geometric Coefficient of Variation|Geometric Mean
127977|NCT00569803|Primary|Serum Half-life (T-HALF) of Belatacept|Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||hours||Standard Deviation|Mean
127999|NCT00569777|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127978|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept|Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL)|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug*h/mL||90% Confidence Interval|Geometric Mean
127979|NCT00569803|Primary|Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept|Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug*h/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug*h/mL||90% Confidence Interval|Geometric Mean
127980|NCT00569803|Primary|Time of Maximum Observed Serum Concentration (Tmax) of Belatacept|Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||hours||Full Range|Median
127981|NCT00569803|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).|Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116|All participants treated with Belatacept||ug/mL||Geometric Coefficient of Variation|Geometric Mean
127982|NCT00569777|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Eyes|Participants||Number
127983|NCT00569777|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects / 4 eyes.||Units on a scale|Participants|Standard Deviation|Mean
127984|NCT00569777|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects/4 eyes.||Units on a scale|Participants|Standard Deviation|Mean
127985|NCT00569777|Primary|Intraocular Pressure, Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||mm of mercury|Participants|Standard Deviation|Mean
127986|NCT00569777|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127987|NCT00569777|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127988|NCT00569777|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127989|NCT00569777|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127990|NCT00569777|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127991|NCT00569777|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127992|NCT00569777|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127993|NCT00569777|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
127994|NCT00569777|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Analysis includes subjects that completed the 12 week visit per protocol.||Units on a scale|Participants|Standard Deviation|Mean
128000|NCT00569777|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.||Units on a scale|Participants|Standard Deviation|Mean
128001|NCT00569673|Secondary|Duration of Progression-free Survival and Overall Survival||up to 5 years||||||
128002|NCT00569673|Primary|Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0||up to 5 years||||||
128003|NCT00569673|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6"|every other cycle for the first 6 months; then every 3 months x 2; then|Total number eligible and evaluable||participants|||Number
128004|NCT00569660|Primary|Number of Participants With Objective Clinical Response|Objective Clinical Response includes Participants with Complete Response, Partial Response or Hematologic Improvement and No Response. Bone marrow aspiration and biopsy with cytogenetics every 2 to 4 courses.|Every 2 courses of 4 week therapy = each 8 weeks|The statistical analysis for response rates determined on the intent-to-treat (ITT) populations. This is defined as all enrolled patients who received at least one dose of study medication.||Participants|||Number
128005|NCT00569582|Primary|Decrease in Diastolic Blood Pressure.|Responder is defined as subject with a decrease greater than or equal to 5mm Hg in diastolic blood pressure from baseline to week 24 or last visit.|Baseline to Week 24|||participants|||Number
128006|NCT00569582|Primary|Improvement in Diabetes and/or Glucose Intolerance.|Responder is defined as subject with a decrease greater than or equal to 25% in area under the curve for glucose on 2-hour oral glucose test from baseline to week 24 or last visit, for Cushing's patients with type-2 diabetes mellitus/impaired glucose tolerance.|Baseline to Week 24|Patients with at least 30 days of dosing.||participants|||Number
128007|NCT00569530|Secondary|Alive Without BPD at 36 Weeks Post Menstrual Age|Alive without need for oxygen at 36 weeks post menstrual age.|36 Weeks Post Menstrual Age|||Number of infants|||Number
128008|NCT00569530|Primary|SP-B Content|SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.|One day after dose|24 of 43 in the Treatment Group and 18 of 42 in the Sham group had samples analyzed. SpB content recorded as a percentage of Total Phospholipids.||Total surfactant protein (% of PL)||Full Range|Mean
128009|NCT00569374|Secondary|Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.|The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40.|Thrice weekly for the first three weeks|The data reported was obtained by computing the overall mean numerical score on the Amphetamine Withdrawal Questionaire for each participant, then using these to compute the overall mean. The scale consists of 13 items ranging from 0 (none) to 4 (worst). The total score ranges from 0 (least) to 52 (worst).||units on a scale||Standard Deviation|Mean
128010|NCT00569374|Primary|Depression as Measured by the Hamilton Depression Scale|Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Depression Scale for each participant, then using these to compute the overall mean. It is a 22 item scale of which 13 items have a score of 0 (none) to 4 (worst) and 9 have a score of 0 (none) to 2 (worst). The total score ranges from 0 (least) to 70 (worst).||units on a scale||Standard Deviation|Mean
128011|NCT00569374|Primary|Anxiety as Measured by the Hamilton Anxiety Scale|Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean score on the Hamilton Anxiety Scale for each participant, then using these to compute the overall mean. The scale is a 14 item instrument with each item scoring a potential range of 0 (none) to 4 (worst). The potential total scores range form 0 (least) to 56 (worst).||units on a scale||Standard Deviation|Mean
128012|NCT00569374|Primary|"Modafinil Side Effects Checklist"|"Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from not at all (0) to very much (4). The score was determined by units on a scale."|Weekly for 7 weeks|The data reported was obtainined by computing the overall mean numberical score on the Modafinil Side Effects Checklist for each participant, then using these to compute the overall mean. The checklist is a 10 item scale with each item scoring between 0 (none) to 4 (worst). The potential scores range from 0 (least) to 40 (worst).||units on a scale||Standard Deviation|Mean
128013|NCT00569374|Primary|Diastolic Blood Pressure|Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean diastolic blood pressure for each participant, then using these to compute the overall mean.||mmHg||Standard Deviation|Mean
128014|NCT00569374|Primary|Systolic Blood Pressure|Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean systolic blood pressure for each participant, then using these to compute the overall mean.||mmHg||Standard Deviation|Mean
128015|NCT00569374|Primary|Heart Rate|Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.|Thrice weekly for 7 weeks|The data reported was obtained by computing the overall mean heart rate for each participant, then using these to compute the overall mean.||beats per minute||Standard Deviation|Mean
128016|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema|baseline to trough tiotropium|High resolution, thin-section scans of the lung were obtained in a subset of 19 patients.||percentage of lung tissue||Standard Deviation|Mean
128017|NCT00569270|Primary|TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo|Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention & 2 hrs. after after 30 days of treatment with either placebo or tiotropium|one hour before intervention & 2 hrs. after after 30 days|lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
128018|NCT00569270|Primary|IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline|IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo|baseline and 30 days (+2h) post dose|Inspiratory capacity (IC) (mean +/- SD) from baseline and after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
128019|NCT00569270|Primary|Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients||liters||Standard Deviation|Mean
128020|NCT00569270|Primary|Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage||percentage of FRC/TLC||Standard Deviation|Mean
128021|NCT00569270|Primary|Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters|30 days|Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters||liters||Standard Deviation|Mean
128022|NCT00569270|Primary|Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients|30 days|Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients||liters||Standard Deviation|Mean
128023|NCT00569270|Primary|Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)|30 days|Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)||liters||Standard Deviation|Mean
128024|NCT00569270|Primary|Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters)|30 days|Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients||liters||Standard Deviation|Mean
128025|NCT00569270|Primary|Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
128026|NCT00569270|Primary|Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage|30 days|Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage||percentage of FRC/TLC||Standard Deviation|Mean
128027|NCT00569270|Primary|Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo|Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters|30 days|Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
128028|NCT00569270|Secondary|IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema|Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema|baseline to 30 days|Analysis was carried out per protocol||percentage of lung tissue||Standard Deviation|Mean
128029|NCT00569270|Primary|Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo|Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters|30 days|Peak FVC after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients.||liters||Standard Deviation|Mean
128030|NCT00569270|Primary|Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)|Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients.|30 days|Includes groups randomized to receive placebo first and Tiotropium first.||Liters||Standard Deviation|Mean
128031|NCT00569270|Secondary|Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium|Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium|baseline to 30 days|High-resolution, thin-section scans of the lung were obtained from a subset of 19 patients.||percentage of lung tissue||Standard Deviation|Mean
128032|NCT00569270|Primary|Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second|30 days|Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second||liters||Standard Deviation|Mean
128033|NCT00569231|Other Pre-specified|Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide|Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.|Initial visit to completion of protocol, which is up to 30 weeks|The interferon-γ enzyme-linked immunospot assay was performed on available samples from participants who completed the study.||Participants|||Number
128034|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 2nd anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|The participants with 2nd anatomically distant, non-injected wart were analyzed.||Participants|||Number
128035|NCT00569231|Secondary|Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart|When the participant completed the protocol, clinical resolution of 1st anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.|Initial visit to completion of protocol, which is up to 30 weeks|Participants with 1st anatomically distant, non-injected wart were analyzed.||Participants|||Number
128036|NCT00569231|Primary|Number of Participants With Clinical Resolution of Injected Wart|When the participant completed the protocol, clinical resolution of the injected wart was determined by the overall percentage of resolution from the initial visit. Participants were classified as 'complete responders' if they had complete resolution of the injected wart, 'partial responders' if the injected wart regressed between 25% and 99%, and 'non-responders' if they had not achieved at least 25% regression of the injected wart.|Initial visit to completion of protocol, which is up to 30 weeks|The participants were analyzed if they completed the protocol by achieving complete resolution of the treated wart, receiving the maximum of 10 treatments, or by having less than 25% resolution of the treated wart after 5 treatments.||Participants|||Number
128037|NCT00569192|Secondary|Change From Baseline in Nighttime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
128038|NCT00569192|Secondary|Change From Baseline in Daytime Individual Symptom Scores|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
128039|NCT00569192|Secondary|Change From Baseline in PEF|The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.||L/min||Standard Deviation|Mean
128040|NCT00569192|Primary|Change From Baseline in Nighttime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 7 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
128050|NCT00569127|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 7 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
128041|NCT00569192|Secondary|Change From Baseline in FEV1% Predicted|The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).|baseline, week 12|The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits.||percentage of predicted FEV1||Standard Deviation|Mean
128042|NCT00569192|Primary|Change From Baseline in Daytime Composite Symptom Score|"The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath.~The individual symptoms were scored using a four point scale:~0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms~Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 7 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms."|baseline, week 12|Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.||units on a scale||Standard Deviation|Mean
128043|NCT00569166|Secondary|Mood States, Fatigue, Sleep Quality, and Blood Pressure Measurements as Assessed by the Symptom Experience Diary, Profile of Mood States, Brief Fatigue Inventory, Pittsburgh Sleep Quality Index, and Blood Pressure Log||5 weeks||10/2016||||
128044|NCT00569166|Primary|The Difference in Hot Flash Score (Frequency and Severity) Between Baseline (Week 1) and Week 9|Hot flash severity were graded from 1 to 4, as they range from mild, moderate, severe, or very severe. A hot flash score is defined by multiplying the daily frequency with the average hot flash severity. These scores are aggregated into average weekly hot flash activity scores for each patient.|Week 1 and Week 9|||units on a scale||Standard Deviation|Mean
128045|NCT00569127|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary. Eleven patients did not start protocol treatment due to: patient refusal (6), financial reasons (3), and worsening condition/progression (2). None were assessable for adverse events and thus are not included in this analysis.||Participants|||Number
128046|NCT00569127|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.||participants|||Number
128047|NCT00569127|Secondary|Local Progression-Free Survival (Investigator Assessed)|From date of randomization (which is the date of registration) to date of first documentation of progression [per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
128048|NCT00569127|Secondary|Time to Treatment Failure|From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
128049|NCT00569127|Primary|Central Review-based Progression-Free Survival|From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.|Up to 3 years|According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.||months||95% Confidence Interval|Median
128051|NCT00569010|Primary|Number of Participants With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery) according to International Working Group (IWG) criteria.|6 weeks|Analysis was per protocol.||participants|||Number
128052|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks|||% days abstinent||Standard Deviation|Mean
128053|NCT00568958|Primary|Percent Days Abstinent From Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline|||% days abstinent||Standard Deviation|Mean
128054|NCT00568958|Secondary|Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.~BAL (Blood Alcohol Level) was estimated using data from the daily diaries based on the number of drinks consumed, the duration of drinking, and total body water (based on gender, age, height and weight) using Curtin’s formula."|8 weeks|||percentage of days||Standard Deviation|Mean
128055|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.|8 Weeks|||drinks per drinking day||Standard Deviation|Mean
128056|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|"Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits.~Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females over an eight week period. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor)."|eight weeks|||percentage of heavy drinking days||Standard Deviation|Mean
128057|NCT00568958|Secondary|Number of Drinks Per Drinking Day|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Baseline measures captured the prior 4 weeks.|Baseline|||drinks per drinking day||Standard Deviation|Mean
128058|NCT00568958|Primary|Frequency of Heavy Episodic Drinking|Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). Baseline measures captured the prior 4 weeks.|Baseline|||percentage of heavy drinking days||Standard Deviation|Mean
128059|NCT00568854|Primary|Kinetics of Mycobacterial-specific Immune Response After BCG Vaccination|Blood was sampled at times 0, 2, 4, 6, 8, 12, 16, and 20 weeks post BCG vaccination and Interferon gamma production was measured as change from pre-vaccination baseline. Timeline of peak IFn-g response was measured for both study groups.|5 months|||weeks when peak response was observed||Standard Deviation|Mean
128060|NCT00568854|Primary|Antigen-specific Immune Response Measured by Reaction to Tuberculin Skin Test|Participants had baseline tuberculin testing (TST), followed by BCG vaccination, and at 5 months after vaccination, study participants had repeat tuberculin skin testing done.|5 months|||mm||Full Range|Median
128061|NCT00568776|Secondary|Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 to 12; hence the total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
128062|NCT00568776|Secondary|Change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The CDR-SB consists of 6 items; 3 measuring cognitive ability and 3 measuring functional ability. The score for each of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
128063|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Per Protocol Set; PPS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.||Scores on a Scale||Standard Error|Mean
128064|NCT00568776|Primary|Change From Baseline to Week 78 in Alzheimer‘s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Score (Full Analysis Set; FAS)|The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
128065|NCT00568776|Primary|Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Per Protocol Set; PPS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Per Protocol Set (PPS): all randomized patients who received at least one dose of ELND005 250 mg or placebo, completed all scheduled visits up to Week 78, were at least 80% compliant with study drug, and met all inclusion/exclusion criteria.||Scores on a Scale||Standard Error|Mean
128066|NCT00568776|Secondary|Change in Alzheimer‘s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Score From Baseline to Week 78 (Full Analysis Set; FAS)|The ADAS-Cog primarily measures cognitive ability. The version used in this study was comprised of 12 items with scores ranging from 0 to 75. Higher scores suggest greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
128067|NCT00568776|Primary|Change From Baseline to Week 78 in Neuropsychological Test Battery (NTB) Z-score (Full Analysis Set; FAS)|The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.|Baseline and 78 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and completed the baseline visit and at least one post-baseline visit.||Scores on a Scale||Standard Error|Mean
128068|NCT00568685|Secondary|Weight Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||kilograms (kg)||Standard Deviation|Mean
128069|NCT00568685|Secondary|Blood Pressure Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||mmHg||Standard Deviation|Mean
128070|NCT00568685|Secondary|Temperature Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||degrees Celsius||Standard Deviation|Mean
128071|NCT00568685|Secondary|Heart Rate Change From Baseline to Day 42 Endpoint||Baseline, Day 42|ITT population||beats per minute (bpm)||Standard Deviation|Mean
128072|NCT00568685|Secondary|Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary|Columbia Suicide-Severity Rating Scale (C-SSRS) captures occurrence, severity & frequency of suicide-related thoughts & behaviors, via questions designed to solicit information to determine if a suicide-related thought or behavior occurred. The C-SSRS is not scored; recorded incidents are counted. C-SSRS was only required if an adverse event was reported that the investigator suspected to represent a suicidal thought or behavior. If the C-SSR was completed at a visit, the Self-Harm Supplement was also required. If a self-harm event was reported, the Self-Harm Follow-Up form was also required.|Baseline to Day 42|As treated population||participants|||Number
128073|NCT00568685|Primary|Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 none/never or rarely) to 3 (severe/very often). Total scores range from 0 (no symptoms) to 54 (highly symptomatic).|Baseline, Day 42|Analysis included all randomized participants (intent-to-treat population)||units on a scale||95% Confidence Interval|Least Squares Mean
128074|NCT00568685|Secondary|Adverse Events Leading to Discontinuation|Adverse Events (Preferred Term) leading to discontinuation by decreasing frequency|Baseline to Day 42|As-treated population||events|||Number
128075|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment. (1=very much improved, 7=very much worsened)|Baseline, Days 7, 14, 42|ITT population; LOCF||units on a scale||Standard Deviation|Mean
128076|NCT00568685|Secondary|Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, Days 7, 14, 42|ITT population; last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
128077|NCT00568555|Secondary|Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|A thermode is placed on the palm, and temperature is increased until the first sensation of pain. That temperature is recorded in Degrees Celsius . The procedure is repeated 3 times and results are averaged into a single temperature recording.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline to final||95% Confidence Interval|Mean
128078|NCT00568555|Secondary|Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.|An algometer is used to apply pressure to 18 points across the body. Pressure is applied until the first sensation of pain in indicated. This pressure is recorded (as kg/cm2) and averaged for all 18 points to provide an overall score.|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline to final||95% Confidence Interval|Mean
128079|NCT00568555|Secondary|Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for fatigue, 0 to 100, where 0 = no fatigue at all and 100 = severe fatigue.~Baseline fatigue calculated averaging daily scores over the 2 week baseline period.~Placebo and LDN fatigue scores calculated by averaging daily scores during the final 3 days of each condition.~Values were converted to percent change in fatigue: [(baseline fatigue - end point fatigue)/baseline fatigue] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline||95% Confidence Interval|Mean
128240|NCT00566930|Primary|Neck Pain|Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)|Up to 10 months|||cm||Standard Deviation|Mean
128080|NCT00568555|Secondary|Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for sleep quality, 0 to 100, where 0 = did not sleep well at all and 100 = slept extremely well.~Baseline sleep quality calculated by averaging daily scores over the 2 week baseline period.~Placebo and LDN sleep quality scores calculated by averaging daily scores during the final 3 days of each condition.~Values were converted to percent change in sleep quality: [(baseline sleep - end point sleep)/baseline sleep] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline||95% Confidence Interval|Mean
128081|NCT00568555|Primary|Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.|"Visual Analogue Scale for pain, 0 to 100, where 0=no pain and 100=worst pain imaginable.~Baseline pain calculated averaging daily pain scores over the 2 week baseline period.~Placebo and LDN pain scores calculated by averaging daily pain scores during the final 3 days of each condition.~Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100."|Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks)|All completers||percentage change from baseline to final||95% Confidence Interval|Mean
128082|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (IFNγ Producing Peptide Specific CTLs) Within a Treatment|For each patient, a time series plot of the number of IFNγ producing peptide specific CTLs will be constructed. The resulting plots will be visually inspected for trends within and between treatments. A point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of the number of IFNγ producing peptide specific CTLs will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.|||||
128083|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (MART-1, Tyrosinase, and gp100) Within a Treatment|For those patients who are HLA-A2+, the maximum post-treatment levels of MART-1, tyrosinase, and gp100 will be determined. For each of these specific melanoma specific antigens, the number of participants (within a given treatment) who gained or maintained immunity based on the maximum post-treatment level of that specific melanoma specific antigen will be determined.|up to 2 years|There is not enough participants to perform this analysis.|||||
128084|NCT00568451|Secondary|Number of Participants Who Experienced Changes in Immunologic Profile (CD4/CD25+ Cells, CD4/Fox-p3+ T Cells) Within a Treatment|Time series plot of the number of circulating cells will be constructed. The resulting plots will be visually inspected for trends within and between treatments. For each cell type, a point and an interval estimate of the number of participants (receiving a given treatment) who had at least a 2-fold increase in the number of circulating cells of that type will be constructed using the properties of the binomial distribution.|up to 2 years|There is not enough participants to perform this analysis.|||||
128085|NCT00568451|Secondary|Duration of Response for All Evaluable Patients Who Have Achieved an Objective Response|Duration of response was defined as the date at which the participant's objective status was first noted to be either a Complete Response or Partial Response to the date the progression was documented.|up to 2 years|Two complete tumor responses were documented. Both participants have since discontinued the study drug after 35 and 24 cycles respectively, and remain disease-free at 39 and 31.5 months since study entry. There is not enough participants to perform this analysis.|||||
128086|NCT00568451|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause.|up to 2 years|||Months||95% Confidence Interval|Median
128087|NCT00568451|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from registration to documentation of disease progression. Disease progression was measured according to the RECIST criteria. Progression: At least a 20 percent increase in the sum of of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to 2 years|||Days||95% Confidence Interval|Median
128088|NCT00568451|Primary|Number of Participants With an Objective Tumor Status of Either a Complete Response(CR) or Partial Response (PR), According to RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|"Response that was noted on 2 consecutive evaluations for at least 4 weeks apart.~CR: Disappearance of all target lesions; PR: At least a 30 percent of decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Target lesions: All measurable lesions up to a maximum of 10 lesions representative of all involved organs."|Every other cycle of therapy (cycle=4 weeks) for the first 6 cycles of treatment|All subjects enrolled, met the eligibility criteria who have signed a consent form and have begun their study treatment were evaluable for response.||participants|||Number
128089|NCT00568399|Primary|Change in Annualized Coronary Calcium Volume Score After Treatment With Sodium Thiosulfate.|We will compare the annualized coronary calcium volume score obtained at the baseline CT of the coronary arteries with another CT obtained of the same coronary arteries following 5 months of sodium thiosulfate treatment.|5 months|This is a feasibility study and all eligible participants were invited to participate. Out of the 48 participates that started, but only 22 completed.||mm3/year||Standard Deviation|Geometric Mean
128090|NCT00568386|Primary|Visual Blur|Visual blur profile is a visual scale ranging from 0 (no blur) to 50 (most blurry). Patients were asked to rate there vision on a specific focal point (an object in the room) through 3 minutes.|3 minutes post dose|||Units on a scale||Full Range|Mean
128091|NCT00568178|Primary|Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36|"The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:~GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)~GFR values were compared to the baseline GFR measure.~[Note: For male participants, ages 13 to 17 years, 0.70 was used as~the multiplier in place of 0.55]~Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only individuals who satisfied the criteria.||Change in GFR mL/min1.73m^2||95% Confidence Interval|Least Squares Mean
128241|NCT00566930|Secondary|Fear Avoidance Belief, Quality of Life, Range of Motion||One year||||||
128796|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128092|NCT00568178|Primary|Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.~*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase."|Baseline and Month 36|Data for analysis was obtained only from participants who had: 1) Baseline measure of Pr/Cr, 2) At least one dose of study drug, and 3) Post randomization measure of Pr/Cr. The number of participants was determined by including only the individuals who satisfied the criteria.||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
128093|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received||mm Hg||95% Confidence Interval|Least Squares Mean
128094|NCT00568178|Secondary|Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12||Baseline and Week 12|All-Participants-As-Treated population which included all randomized participants who received at least 1 dose of study therapy, and each participant was counted in the treatment group of the drug they actually received.||mm Hg||95% Confidence Interval|Least Squares Mean
128095|NCT00568178|Primary|Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12|"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.~Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period."|Baseline and Week 12|Full Analysis Set included all randomized participants who took at least one dose of study drug and had baseline and post randomization measurements available||Percent Change in Pr/Cr||95% Confidence Interval|Geometric Mean
128096|NCT00568087|Secondary|Alcohol Craving (Obsessive Compulsive Drinking Scale)|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Obsessive Compulsive Drinking Scale (OCDS) is a self-rated scale designed to assess alcohol craving. The score range of the OCDS is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving."|Alcohol craving (Obsessive Compulsive Drinking Scale) was measured at each weekly visit during the 8 weeks.|||units on a scale||Standard Error|Mean
128097|NCT00568087|Secondary|Alcohol Craving (Penn Alcohol Craving Scale)|"Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).~The Penn Alcohol Craving Scale (PACS) is a self-rated scale designed to assess alcohol craving. The score range of the PACS is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving."|Alcohol craving (Penn Alcohol Craving Scale) was measured at each weekly visit during the 8 weeks.|||units on a scale||Standard Error|Mean
128098|NCT00568087|Secondary|Liver Function Tests||8 weeks||||||
128099|NCT00568087|Primary|Alcohol Consumption (Percentage of Heavy Drinking Days)|The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.|The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.|All 44 subjects who received intervention were included in analysis.||percentage of heavy drinking days||Standard Error|Mean
128100|NCT00568061|Secondary|Change in Adverse Remodeling Parameters Compared With 48-72 Hrs: Changes in LV End-diastolic Vol, End-systolic Vol, End-diastolic Myocardial Wall Thickness in Infarct, Peri-infarct and Remote Areas, and in Sphericity Index at End-diastole and End-systole||4 months||||||
128101|NCT00568061|Secondary|Troponin T Levels and CPK-MB Area Under the Curve||48 hours||||||
128102|NCT00568061|Secondary|Resolution of ST Segment Elevation Compared With That Observed at Enrollment||4 hours||||||
128103|NCT00568061|Secondary|MI Size as a Fraction of LV Size||4 months||||||
128104|NCT00568061|Secondary|Change in Global LV Function and Mass||between 48-72 hours and 4 months||||||
128105|NCT00568061|Secondary|Global & Regional LV Function and LV Mass||48-72 hours and 4 months||||||
128106|NCT00568061|Secondary|Infarct Transmurality||48-72 hours and 4 months||||||
128107|NCT00568061|Secondary|Myocardial Perfusion at Coronary Angiography||at completion of PCI||||||
128108|NCT00568061|Secondary|MI Size Normalized to Area at Risk||48-72 hours||||||
128109|NCT00568061|Secondary|MI Size at 48-72 Hours||48-72 hours||||||
128110|NCT00568061|Primary|Mean Percent of Myocardial Infarction Size to the Fraction of Left Ventricular Size|The primary endpoint - mean percent of the myocardial infarction size to the fraction of left ventricular size at 48-72 hours was measured by contrast-enhanced cardiac Magnetic Resonance Imaging (MRI).|48-72 hours|Analysis was per intent to treat population||percent of myocardial infarction size||Standard Deviation|Mean
128111|NCT00568022|Primary|Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)|The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity.|At the end of Cycle 2 (Day 42)|All participants treated at the highest dose level.||Participants|||Number
128112|NCT00568022|Secondary|Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval|CLT = total body clearance as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||L/h||Standard Deviation|Mean
128113|NCT00568022|Secondary|Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval|Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||Liters||Standard Deviation|Mean
128114|NCT00568022|Secondary|Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval|T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||Hours||Standard Deviation|Mean
128115|NCT00568022|Secondary|Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval|AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
128116|NCT00568022|Secondary|Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.|During Cycle 1 at specified timepoints (Day 1 to Day 8).|All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
128117|NCT00568022|Secondary|Participant Tumor Response at Study Endpoint|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which complete response (CR) = disappearance of all target lesions; partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; and stable disease (SD) = small changes that do not meet above criteria.|At baseline and after every 42 days (every 2 21-day cycles) after baseline|All treated participants with measurable disease and tumor response.||Participants|||Number
128118|NCT00568022|Secondary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug|Baseline to Day 42, continuously|All participants who received at least 1 dose of either ixabepilone or capecitabine.||Participants|||Number
128119|NCT00568022|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.|From initiation of drug through last day of Cycle 2 (Day 42)|All participants who received at least 1 dose of either ixabepilone or capecitabine.||Participants|||Number
128120|NCT00567996|Secondary|"Percentage of COPD Days of Poor Control During 26 Weeks of Treatment"|"Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of “days of poor control”, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates."|Up to 26 weeks|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.||Percentage of days||Standard Error|Least Squares Mean
128121|NCT00567996|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had SGRQ data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).||Score on a scale||Standard Error|Least Squares Mean
128122|NCT00567996|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|Week 12|Intent-to-treat population included all randomized participants who received at least one dose of study medication. The end point was analyzed only for those participants who had Trough FEV1 data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF).||Liters||Standard Error|Least Squares Mean
128123|NCT00567892|Secondary|Perceived Global Impression of Change (PGIC: Number of Participants With Perceived Global Impression of Change (PGIC) of 1 or Greater|"PGIC is a 7 point scale ranging from -3 to +3,with 0 meaning no change,negative values reporting worsening of symptoms(Tinnitus), and values of +1 or above reporting perceived improvement of Tinnitus.~PGIC score post active rTMS treatment treatment will provide subject's impression of change in tinnitue due to active treatment.PGIC score post rTMS sham will provide subject's impression of change in tinnitus due to sham. Number of subjects with scores of 1 or above are recorded to perceive improvement due to treatment of the corresponding study arm."|End of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.||participants|||Number
128124|NCT00567892|Primary|Change in THI (Tinnitus Handicap Inventory)|Tinnitus Handicap Inventory (THI) is a measure of bother from tinnitus. THI is measured as a score in a scale ranging from 0=No bother to 100=Extremely Bothered. THI score post active rTMS treatment minus THI score pre active rTMS treatment will provide the change in THI score due to active treatment. THI score post rTMS sham minus THI score pre rTMS sham will provide change in THI due to sham. The difference of THI change due to active treatment minus THI change due to sham will provide the THI change that is our primary outcome measure.|baseline at the start of each treatment period, end of each treatment period (2 or 4 weeks)|Study participant that successfully completed both study parts active rTMS treatment and sham rTMS treatment were included in analysis.||units on a scale||95% Confidence Interval|Median
128125|NCT00567879|Secondary|Number of Participants With Best Overall Response|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|day 21|The full analysis set was analyzed. The full analysis set included all randomized participants.||Participants|||Number
128126|NCT00567879|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.|day 21|The Maximum Tolerated Dose (MTD) determining set was used for this analysis. The MTD determining set consisted of all participants who either received sufficient study drug and had sufficient safety evaluations or discontinued due to unacceptable toxicity.||Participants|||Number
128127|NCT00567593|Primary|PDK4 mRNA||14 days|||copies/nL||Full Range|Median
128128|NCT00567541|Primary|Relief of Chronic Shoulder Pain|Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.|From baseline to 48 week follow up|Intent to Treat population was analyzed||participants|||Number
128129|NCT00567502|Primary|Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events|SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.|Up to 5 years|"Overall treatment safety population. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. Participants who had exposed to XAGRID (alone or in combination with other) was counted in Xagrid arm and those who had received other ET therapy in the Other (Cytoreductives)."||participants|||Number
128130|NCT00567502|Secondary|Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy|Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||milligram (mg)||Standard Deviation|Mean
128131|NCT00567502|Secondary|Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy|Total duration for each participant = sum of [stop date - start date + 1] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||days||Standard Deviation|Mean
128132|NCT00567502|Secondary|Platelet Count||Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60|Overall Treatment Safety population, Here n = participants evaluable at specified time-points. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||10^9 per Liter (10^9/L)||Standard Deviation|Mean
128133|NCT00567502|Secondary|Event Rate of Thrombohaemorrhagic Events|Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.|Up to 5 years|Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.||participants/100 participant-years|||Number
128134|NCT00567502|Primary|Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies|Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.|Up to 5 years|First Treatment Safety Population included participants who received cytoreductive therapy at registration. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment.||percentage of participants|||Number
128797|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|24 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128135|NCT00567476|Secondary|Patient's Global Assessment of Treatment Effectiveness|"At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale:~Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma"|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.||Participants|||Number
128136|NCT00567476|Secondary|Physician's Global Assessment of Treatment Effectiveness|At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma|20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.||Participants|||Number
128137|NCT00567476|Secondary|Mean Number of Puffs of Rescue Medication Taken Per Day|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population. Number of patients analyzed includes only those patients requiring rescue medication during the study.||Puffs||Standard Deviation|Mean
128138|NCT00567476|Secondary|Free Days With no Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.|From Baseline through 20 weeks (140 days)|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.||Days||Standard Deviation|Mean
128139|NCT00567476|Secondary|Percentage of Participants Using Rescue Medication|When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.|From Baseline through 20 Weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.||Percentage of participants||95% Confidence Interval|Number
128140|NCT00567476|Secondary|Number of Asthma Exacerbation Episodes Per Participant|For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.|From Baseline through 20 weeks|All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.||Participants|||Number
128141|NCT00567476|Secondary|The Mean Change From Baseline to the End of Study in AQLQ Domain Score|"AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration.~The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment."|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Units on a scale||Standard Error|Mean
128142|NCT00567476|Primary|The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ)|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Units on a scale||Standard Error|Mean
128143|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Percentage of participants||95% Confidence Interval|Number
128242|NCT00566735|Secondary|Baseline Depressive Symptoms|This measure refers to the Hamilton Rating Scale for Depression-17 scores (HAM-D-17) which can range from 0 to 50, with <7 referring to mild-to-no depression, and >23 referring to severe depression.|Participants were questioned at baseline|||Score on the HAM-D-17||Standard Deviation|Mean
128144|NCT00567476|Secondary|Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks|The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.|Baseline and Week 20|Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.||Percentage of participants||95% Confidence Interval|Number
128145|NCT00567320|Primary|Proportion of Cocaine Positive Urine Tests Per Week|Urine samples were obtained thrice-weekly and analyzed for the presence of cocaine metabolites. Levels that exceeded 300 ng / ml on each individual urine test were considered positive. The primary outcome measure was the proportions of positive cocaine urine results per week that was calculated by using the total number of completed tests as the denominator and the total number of positive tests for that week as the numerator. This data was subjected to Hierarchical Linear Modeling (HLM) analysis using a total of 13 longitudinal results that included a baseline result (Week 0).|Weekly Measures over 12 weeks|Intention to treat analysis of all subjects receiving medication||Proportion of cocaine positive||Standard Deviation|Mean
128146|NCT00567307|Primary|Reduction of the Estimated 10-year Total Cardiovascular Risk Score|Estimated 10-year CVD total risk score were calculated in the field centers and in the Coordinating Center from the measures of blood pressure and total cholesterol and from the medical history data collected during each visit using the WHO CVD prediction chart. The estimated 10-year CVD total risk calculated by the Coordinating Center were used for analysis.|Six months|||percent||Standard Deviation|Mean
128147|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy|Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
128148|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance|Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
128149|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
128150|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
128151|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
128152|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories|Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
128153|NCT00567268|Other Pre-specified|Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)|Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants who had diseases not eligible for the survey were excluded from the efficacy analysis population.||participants|||Number
128536|NCT00564629|Secondary|Maximum Temperature Reduction Observed From T0 to T360 Minutes|This outcome measures the maximum core temperature reduction observed from T0 to T360 minutes. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|T0-T360 minutes|Analysis performed on the mITT population.||Degrees Celsius||Standard Deviation|Mean
128154|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by the number of concomitant antiepileptic drugs at baseline across 5 categories to assess whether the number of concomitant antiepileptic drugs at baseline was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
128155|NCT00567268|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by age across 7 categories to assess whether the age was a risk factor for the treatment-related adverse events.|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
128156|NCT00567268|Secondary|Percent Reduction From Baseline in Epileptic Seizure Frequency|Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100.|12 weeks|The analysis population comprised of the participants whose frequency of epileptic seizures during 4 weeks before gabapentin treatment (represented by B) was at least once within the R ratio analysis population.||Percentage||Standard Deviation|Mean
128157|NCT00567268|Secondary|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|12 weeks|Responder rate analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.||Percentage of participants||95% Confidence Interval|Number
128158|NCT00567268|Secondary|Response Ratio (R Ratio)|Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.|12 weeks|R ratio analysis population comprised of the participants who calculated R ratio at the start of gabapentin treatment and at the end of monitoring period in the efficacy analysis population.||Ratio||Standard Deviation|Mean
128159|NCT00567268|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|12 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency within the safety analysis population. Participants who had disease not eligible for the survey were excluded from the efficacy analysis population.||Percentage of participants||95% Confidence Interval|Number
128160|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
128161|NCT00567268|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).|12 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.||participants|||Number
128162|NCT00567255|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
128163|NCT00567255|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
128164|NCT00567255|Secondary|Change in IDS-SR Total Score|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
128165|NCT00567255|Secondary|Change in Diastolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
128166|NCT00567255|Secondary|Change in Systolic Blood Pressure||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
128167|NCT00567255|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
128168|NCT00567255|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
128169|NCT00567255|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
128170|NCT00567255|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
128171|NCT00567255|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
128172|NCT00567255|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
128173|NCT00567255|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
128174|NCT00567255|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 28 weeks|||percent change||95% Confidence Interval|Least Squares Mean
128175|NCT00567255|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
128176|NCT00567255|Secondary|Change in Waist Circumference||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
128177|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
128178|NCT00567255|Secondary|Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
128179|NCT00567255|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28||Baseline, 28 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
128798|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|12 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128180|NCT00567255|Secondary|Body Weight- Mean Percent Change From Baseline to Week 56|"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)."|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
128181|NCT00567255|Primary|Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28||Baseline, 28 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
128182|NCT00567242|Secondary|Category Member Generation Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception of one control subject whose baseline was not stable.||Z score||Standard Deviation|Mean
128183|NCT00567242|Secondary|Picture Naming Probe Scores (% Accuracy)|Improvement for the time series from 8 baseline sessions through 30 treatment sessions for naming probes was computed with the C statistic using Tryon's (1982, 1983) formula for each subject. C statistics were converted to Z scores, using the formula provided by Tryon (1982). Z scores indicated treatment change for each subject, with a positive and significant Z score indicating substantive treatment gains. Z scores were then compared between groups with a t statistic. It was expected that the intention manipulation would lead to greater treatment gains than when it was not used.|trend for time series of 8 baseline + 30 treatment sessions|Data from all subjects completing their respective arms were analyzed, with the exception that one control subject was eliminated because of an unstable baseline measure.||Z score||Standard Deviation|Mean
128184|NCT00567242|Primary|Lateralization of Frontal Lobe (and Posterior Perisylvian) Activity During Word Production|Functional MRI laterality indices (LIs)were calculated for lateral frontal, medial frontal, and posterior perisylvian cortex regions of interest (ROIs): L=number of active voxels in left hemisphere ROI and R=number of active voxels in right hemisphere ROI using the following formula: (L-R)/(L+R). LIs could vary from -1 (completely right lateralized) to +1 (completely left lateralized). Then, change in LIs was calculated by subtracting the pre-treatment from the post-treatment and 3-mo follow-up LI. It was expected the intention manipulation would show a rightward shift in LI.|immediately post-treatment scan minus pre-treatment baseline scan|Data for all subjects completing the protocol for their respective arm were analyzed.||laterality index||Standard Deviation|Mean
128185|NCT00567229|Primary|Final Response Rate After 4 Courses of Treatment||2 years|||participants|||Number
128186|NCT00567190|Secondary|Time to Symptom Progression|Time to symptom progression was defined as the time from randomization to the first symptom progression as measured by the Functional Assessment of Cancer Therapy-for patients with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contains 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer patients (breast cancer subscale [BCS]). All items in the questionnaire were rated by the patient on a 5-point scale ranging from 0 (“not at all”) to 4 (“very much”). The total score ranged from 0 to 96. A higher score indicates better perceived quality of life. A positive change score from baseline indicates improvement. Symptom progression was defined as a decrease from baseline of 5 points or more.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only female patients were included in the analysis.||Weeks||95% Confidence Interval|Median
128187|NCT00567190|Secondary|Duration of Objective Response Determined by an Independent Review Facility|Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only patients with an objective response were included in the analysis.||Weeks||95% Confidence Interval|Median
128188|NCT00567190|Secondary|Objective Response Determined by an Independent Review Facility|A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat population: All randomized patients. Only patients with measurable disease at baseline were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
128243|NCT00566735|Secondary|Cognitive Functioning|This measure refers to participants' scores on the Delayed Memory Index (DMI) compared from baseline (before first ECT) to discharge (after last ECT). The score can range from 40 to 137. The higher the score, the better, in terms of cognitive functioning.|Participants were questioned at baseline and after their last electroconvulsive therapy treatment|||Score on the DMI||Standard Deviation|Mean
128189|NCT00567190|Secondary|Progression-free Survival (PFS) Determined by the Investigator|PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as target lesions.|Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
128190|NCT00567190|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause. The median and 95 percent (%) confidence interval (CI) for time to event were estimated using Kaplan-Meier methodology.|Baseline to the third data cut-off (11 February 2014) at 389 deaths (approximately 43 months after enrollment of the last patient, up to 6 years overall)|Intent-to-treat population: All randomized patients.||Months||95% Confidence Interval|Median
128191|NCT00567190|Primary|Progression-free Survival (PFS) Determined by an Independent Review Facility|PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause (within 18 weeks of last tumor assessment), whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as target lesions.|Baseline to primary data cut-off on 13 May 2011 (up to 3 years, 3 months)|Intent-to-treat (ITT) population: All randomized patients.||Months||95% Confidence Interval|Median
128192|NCT00567164|Secondary|Length of Cycles|Cycle length per cycle. For the flexible and stop and go extended treatment arms, a treatment cycle started with the first day of pill intake after a tablet-free interval and ended with the last day of the subsequent tablet-free interval. A tablet-free interval (treatment withdrawal) was defined as at least 3 consecutive days without tablet intake. For the standard 24+4 treatment arm, a new cycle started each time a new blister pack of medication was started.|Up to 1 year|Full Analysis Set (ie, all treated participants). Only cycle data from participants with sufficient data to calculate cycle length are included.||Days|Participants|Standard Deviation|Mean
128193|NCT00567164|Secondary|Number of Scheduled and Unscheduled Bleeding Days|Scheduled bleeding is any bleeding/spotting (bl/sp) that occurs during the tablet free interval through the next 4 days of the subsequent treatment cycle. Unscheduled bleeding is any bl/sp that occurs while taking active hormones, except for bl/sp that occurs during the tablet free interval through day 4 of the subsequent treatment cycle or bl/sp on days 1-7 of treatment cycle 1.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate scheduled/unscheduled bleeding. Analysis was only performed for the flexible and stop-and-go extended regimens.||Days||Standard Deviation|Mean
128194|NCT00567164|Secondary|Number of Intracyclic Bleeding Days|Intracyclic bleeding was considered any bleeding/spotting that occurred between withdrawal bleedings.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding and tablet intake data sufficient to calculate intracyclic bleeding.||Days||Standard Deviation|Mean
128195|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who received treatment in cycle 14 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300). There were no participants who provided bleeding data for cycle 14 in the Flexible (extended) regimen no.2 of EE20/DRSP (BAY86-5300), although one woman did receive 14 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 14.||Percentage of Participants|||Number
128196|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE. There were no participants who provided bleeding data for cycle 13 in the Flexible (extended) regimen no.1 of EE20/DRSP (BAY86-5300), although one women did receive 13 cycles of treatment.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 13.||Percentage of Participants|||Number
128244|NCT00566735|Primary|Number of Side Effects|This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.|Participants were followed for the duration of hospital stay, an average of 3 weeks|||Number of reported side effects|||Number
128197|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 12.||Percentage of Participants|||Number
128198|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 11.||Percentage of Participants|||Number
128199|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 10.||Percentage of Participants|||Number
128200|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 9.||Percentage of Participants|||Number
128201|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 8.||Percentage of Participants|||Number
128202|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 7.||Percentage of Participants|||Number
128203|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 6.||Percentage of Participants|||Number
128204|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 5.||Percentage of Participants|||Number
128246|NCT00566722|Secondary|Percent Activity Impairment Due to Psoriasis|Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was using for missing data. Screening data were not available for all participants.||Change in percent activity impairment||Standard Deviation|Mean
128205|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 4.||Percentage of Participants|||Number
128206|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 3.||Percentage of Participants|||Number
128207|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 2.||Percentage of Participants|||Number
128208|NCT00567164|Secondary|Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1|A withdrawal bleeding episode (WBE) for the two flexible (extended) treatment arms 1) Ended at the earliest 4 days before the first day of the pill break of that cycle or later, AND 2) Started before or at the latest on the 4th day of the next cycle. For the conventional 24+4 treatment arm, a WBE 1) Started on or after Day 21 of that cycle, and lasted at least until Day 25 of the same cycle, OR 2) Started on or after Day 25 of that cycle, but before Day 25 of the next cycle. If more than one episode satisfied the above criteria, the first episode to occur was considered to be the WBE.|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for cycle 1.||Percentage of Participants|||Number
128209|NCT00567164|Secondary|Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 4. Reference period 4 (Day 271 to Day 360) was a 90-day period that started with the intake of study medication at the beginning of Cycle 10.|Day 271 to Day 360|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 4.||Days||Standard Deviation|Mean
128210|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 3. Reference period 3 (Day 181 to Day 270) was a 90-day period that started with the intake of study medication at the beginning of Cycle 7.|Day 181 to Day 270|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 3.||Days||Standard Deviation|Mean
128211|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 2. Reference period 2 (Day 91 to Day 180) was a 90-day period that started with the intake of study medication at the beginning of Cycle 4.|Day 91 to Day 180|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 2.||Days||Standard Deviation|Mean
128212|NCT00567164|Secondary|Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1.|Number of days per participant with bleeding (including and excluding spotting) within 90-day reference period 1. Reference period 1 (Day 1 to Day 90) was a 90 day period starting with the initial intake of study medication (protocol-specified to occur on first day of menstrual or withdrawal bleeding after screening). Therefore, the first 90-day reference period contains additional bleeding days (associated with the menstrual cycle prior to the start of study medication) when compared to any other reference period.|Day 1 to Day 90|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data for reference period 1.||Days||Standard Deviation|Mean
128213|NCT00567164|Secondary|Number of Bleeding Days (Excluding Spotting Days)|Number of days per participant with bleeding (excluding spotting days)|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.||Days||Standard Deviation|Mean
128214|NCT00567164|Secondary|Number of Bleeding Days (Including Spotting Days)|Number of days per participant with bleeding or spotting|Up to 1 year|Full Analysis Set (ie, all treated participants). The number of participants analyzed only includes women who provided bleeding data.||Days||Standard Deviation|Mean
128245|NCT00566722|Secondary|Sleep Problems Index II|"Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from none of the time to all of the time for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement."|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants for all items; as a result, not all participants were included in the analysis.||Change in scores on a scale||Standard Deviation|Mean
128215|NCT00567164|Primary|Pearl Index|The Pearl Index (PI) is the number of pregnancies per 100 woman years. The PI is obtained by dividing the number of pregnancies during treatment (conception date on/after the 1st day of treatment and not later than last day of treatment +14 days) by the treatment exposure time (in 100 women years) that the women were under risk of getting pregnant. The Pearl Index was not calculated individually for either the Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arm, nor for the Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300) treatment arm, because the low sample size in these treatment arms (approximately. 200 subjects per group) did not allow a reliable PI calculation of these groups alone.|Up to 1 year|Full Analysis Set of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) treatment arm. Pooled Full Analysis Sets of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) and Regimen no. 2 of EE20/DRSP (BAY86-5300) treatment arms.||Pregnancies per 100 years of exposure||95% Confidence Interval|Mean
128216|NCT00567112|Secondary|t1/2 for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements||hours||Full Range|Median
128217|NCT00567112|Secondary|Tmax for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements||hours||Full Range|Median
128218|NCT00567112|Primary|Half Life (t½) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with t1/2 measurements||hours||Full Range|Median
128219|NCT00567112|Primary|Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Tmax measurements||hours||Full Range|Median
128220|NCT00567112|Secondary|Cmax of OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements||nM||Full Range|Least Squares Mean
128221|NCT00567112|Secondary|AUC(0-∞) for OCT (Fasted) and OCT (After Meal)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements||nM*hr||Full Range|Least Squares Mean
128222|NCT00567112|Primary|Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)||From study drug administration to 72 hours post-administration|Participants with Cmax measurements||nM||Full Range|Least Squares Mean
128223|NCT00567112|Primary|Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)||From study drug administration to 72 hours post-administration|Participants with AUC(0-∞) measurements||nM*hr||Full Range|Least Squares Mean
128224|NCT00567008|Primary|Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.|Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.|8 weeks|||participants|||Number
128225|NCT00566995|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|72 months and 14 days|||participants|||Number
128226|NCT00566995|Primary|Overall Response Rate.|Overall response rate is defined as the percentage of participants with either a partial or complete response occurring at any time after initiation of therapy. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response (CR) is a disappearance of all target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started.|cycle 3, day 28|||percentage of participants|||Number
128227|NCT00566982|Secondary|Visual Evaluation of the Vagina (Baseline & Week 52)||52 weeks|ITT||participants|||Number
128228|NCT00566982|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||52 weeks|ITT||nmol/L||Standard Deviation|Mean
128229|NCT00566982|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||52 weeks|ITT||U/L||Standard Deviation|Mean
128230|NCT00566982|Secondary|Change From Baseline in Luteinizing Hormone Levels||52 weeks|ITT||U/L||Standard Deviation|Mean
128231|NCT00566982|Secondary|Change From Baseline in Estradiol Levels||52 weeks|ITT||nmol/L||Standard Deviation|Mean
128232|NCT00566982|Primary|Mean Change From Baseline in Vaginal pH||12 weeks|ITT||pH||Standard Deviation|Mean
128233|NCT00566982|Primary|Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear||12 weeks|ITT||percentage of superficial cells||Standard Deviation|Mean
128234|NCT00566982|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||12 weeks|ITT||percentage of parabasal cells||Standard Deviation|Mean
128235|NCT00566969|Primary|Percent Days Abstinent From Cocaine - Self Report|Percent Self reported days of abstinence from any cocaine use during the 11 week trial.|11 weeks|||percentage of days||Standard Deviation|Mean
128236|NCT00566943|Secondary|Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.|Stricture requiring intervention comparison between control group and PSD Vertas group. Bleeding assessment comparison of control group to PSD Veritas Group. These results will combine both stricture and bleeding since this was how it was entered in to the database.|Discharge, 30 and 90 days|||participants|||Number
128237|NCT00566943|Secondary|Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group|Comparison of number of subjects who required use of Endoclips or sutures for bleeding in Control group versus the number of subjects who required use of Endoclips or sutures for bleeding in PSD Veritas group in the linear arm of the study.|Discharge and 30 days|||Participants|||Number
128238|NCT00566943|Primary|Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.|Leak as determined by a comparison of control group to PSD Veritas group in both linear and circular arms.|Discharge/30 Linear Discharge/30/90 days Circular|||Participants|||Number
128239|NCT00566943|Primary|Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.|Adverse events as measured through hospital discharge and 30 days post-discharge in both the linear and circular arms of the study.|Discharge/ 30 days Linear Discharge/30/90 days Circular|||Participants|||Number
128247|NCT00566722|Secondary|Percent Impairment While Working Due to Psoriasis|Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.||Change in % impairment while working||Standard Deviation|Mean
128248|NCT00566722|Secondary|Percent Overall Work Impairment Due to Psoriasis|Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.||Change in % overall work impairment||Standard Deviation|Mean
128249|NCT00566722|Secondary|Percent Work Time Missed Due to Psoriasis|Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab are included. Last observation carried forward was used for missing data. Screening data were not available for all participants.||Change in percent time missed||Standard Deviation|Mean
128250|NCT00566722|Secondary|Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis|The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.|From Screening to Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.||Change in scores on a scale||Standard Deviation|Mean
128251|NCT00566722|Secondary|Psoriasis-related Pruritus Assessment|The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.|From Screening to Week 16|All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data.||Change in scores on a scale||Standard Deviation|Mean
128252|NCT00566722|Secondary|Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16|DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.|Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (score of 0 not achieved) was used for missing data.||Participants|||Number
128253|NCT00566722|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.|From Screening to Week 4 and Week 16|All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.||Change in scores on a scale||Standard Deviation|Mean
128254|NCT00566722|Secondary|Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8|The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.|Weeks 2, 4, and 8|All participants who received at least 1 dose of adalimumab are included. Nonresponder imputation was used for missing data; that is, participants who did not have an evaluation at the time point were assumed to not have achieved a 0 or 1 on the PGA.||Participants|||Number
128255|NCT00566722|Secondary|Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening||From Screening to Week 16|All participants who were enrolled and received a dose of adalimumab were included. Non-responder imputation (1 grade of improvement not achieved) was used for missing data.||Participants|||Number
128256|NCT00566722|Secondary|Number of Participants Achieving a PGA of Clear (0) at Week 16||Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear [0] not achieved) was used for missing data.||Participants|||Number
128257|NCT00566722|Primary|Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16|The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).|Week 16|All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear or minimal not achieved) was used for missing data.||Participants|||Number
128258|NCT00566709|Secondary|Unfavorable Glasgow Outcome Scale (GOS)|"GOS measures the degree of disability associated with the brain injury~Unfavorable GOS included the categories of:~death.~vegetative status.~severe disability."|At hospital discharge, an average of 21 days|||participants|||Number
128259|NCT00566709|Secondary|Long-term Mortality||1-year after hospital discharge|||participants|||Number
128260|NCT00566709|Secondary|Length of Intensive Care Unit (ICU) Stay||The length of ICU stay, an avarege of 17 days|||days||Standard Deviation|Mean
128261|NCT00566709|Secondary|Hospital Mortality||length of the hospital stay, an average of 20 days|||participants|||Number
128262|NCT00566709|Primary|Percentage of Transfused Patients in Each Group||duration of the protocol, an average of 15 days|||percentage of transfused participant|||Number
128263|NCT00566709|Primary|Number of Units of Packed Red Blood Cell Transfused|Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol|duration of the protocol, an average of 15 days|||units||Standard Deviation|Mean
128267|NCT00566696|Secondary|Incidence of Non-hematologic Regimen-related Toxicities|Estimate of the incidence of non-hematologic regimen-related toxicity and regimen-related toxicity in the first 100 days post-transplant. The percentage of participants are reported by maximum grade seen using binomial distribution. Participants were graded for toxicity using Common Terminology Criteria for Adverse Events version 3.0. In general, Grade 1 is mild, 2 is moderate toxicity but generally does not require treatment, 3 is severe enough to require treatment, 4 is life-threatening, and 5 means it was associated with death.|100 days post-transplant|||percentage of participants|||Number
128268|NCT00566696|Secondary|Disease-Free Survival (DFS)|Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|One year post-transplant|||Percentage of participants|||Number
128269|NCT00566696|Secondary|Overall Survival (OS)|Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant|||Percentage of participants|||Number
128270|NCT00566696|Primary|Event-free Survival (EFS)|To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis.|one year post-transplant|||Percentage of participants|||Number
128271|NCT00566631|Other Pre-specified|Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The BARS included an objective rating (from 0=normal to 3=constantly engaged), two subjective ratings of symptoms of akathisia, namely awareness of restlessness (ranging from 0=absence of inner restlessness to 3=awareness of intense compulsion to move) and reported distress related to restlessness (ranging from 0=no distress to 3=severe), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). Global rating sub-scale score (that is, global clinical rating of akathisia) was assessed which was scored separately and is the most relevant measure of severity of akathisia. Higher scores indicates worsening akathisia. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
128272|NCT00566631|Other Pre-specified|Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The SAS rates 10 items (including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, Glabella tap, tremor and salivation), score ranging from 0 (normal) to 4 (extreme). The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score indicates more severe condition of Extrapyramidal Symptoms. Final evaluation is the last post- baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
128273|NCT00566631|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none and 4=severe). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)|"Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
128274|NCT00566631|Secondary|Number of Participants Satisfied With the Study Treatment|Treatment satisfaction with paliperidone ER was assessed by the Investigator and participant on a 5-point scale: 1 (very good), 2 (good), 3 (reasonable), 4 (moderate) and 5 (poor), at the end of the core treatment phase (which is, Day 42 or early discontinuation) by conducting an interview.|Day 42 or early discontinuation|The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure at given time point.||Participants|||Number
128275|NCT00566631|Secondary|Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The day time drowsiness evaluation scale is a self-administered scale that rates day time drowsiness. Participants indicate on an 11-point scale that how often they have felt drowsy within the previous 7 days, score ranged from 0 (not at all) to 10 (all the time). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
128276|NCT00566631|Secondary|Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The sleep evaluation scale is a self-administered scale that rates quality of sleep. Participants indicate on an 11-point scale that how well they have slept within the previous 7 days, score ranged from 0 (very badly) to 10 (very well). Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
128277|NCT00566631|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PSP assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal & social relationships, self-care & disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Final evaluation is the last post-baseline visit with data.|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a Scale||Standard Deviation|Mean
128278|NCT00566631|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data."|Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
128279|NCT00566631|Secondary|Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.||Percentage of participants|||Number
128280|NCT00566631|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms and disorganized thoughts subscale, consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement (H/E) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity. Final evaluation is the last post-baseline visit with data.|Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)|The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
128281|NCT00566631|Secondary|Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Final evaluation is the last post-baseline visit with data.|Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)|"The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. “n signifies those participants who were evaluated for this measure at given time points."||Units on a scale||Standard Deviation|Mean
128282|NCT00566631|Primary|Number of Participants With Treatment Response Based on Total PANSS Scale Score|Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, & poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of sum of all 30 PANSS items & ranges from 30 to 210. Higher scores indicate worsening.|Day 42 or early discontinuation|Intent-to-treat (ITT) population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.||Participants|||Number
128283|NCT00566579|Primary|Number of Patients With Human Papillomavirus Clearance|At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.|12 months|||participants|||Number
128284|NCT00566501|Secondary|Mean Change From Baseline in SIB Score|The Severe Impairment Battery (SIB) evaluates the severity of cognitive dysfunction in patients with more advanced dementia.|12 months||||||
128286|NCT00566501|Primary|Long-term Safety as Measured by Incidence of Adverse Events During the 12 Month Treatment Period|Adverse events (AEs), including SAEs, were recorded from the time of consent. Recording of AEs ceased after the Final Visit or Early Termination Visit, except that SAEs were monitored for 30 days after study drug discontinuation.|Throughout the study ( 12 months for all AEs and up to an additional 30 days for SAEs)|The Safety Population consisted of all subjects who received at least one dose of donepezil SR 23 mg during Study 328. Two groups were categorized: those who received donepezil 10 mg IR and those who received donepezil 23 mg SR during Study 326.||participants|||Number
128287|NCT00566462|Secondary|Change in Caudate and Putamen [^123I]-IBZM Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|||Percent Change||Standard Deviation|Mean
128288|NCT00566462|Primary|Change in Striatal [^123I]-Iodobenzamine (IBZM_ Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4||Baseline and Week 4|||Percent Change||Standard Deviation|Mean
128289|NCT00566254|Secondary|Percent of Participants With =25% and =100% Increase From Baseline in 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population||Percentage of Participants|||Number
128290|NCT00566254|Secondary|Percent of Participants With =50% to < 75% and = 75% Decrease From Baseline in 28-day Seizure Frequency During the Maintenance Period(LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population||Percentage of Participants|||Number
128291|NCT00566254|Secondary|Median Percent Change From Baseline in the 28-day Seizure Frequency During the Maintenance Period (LOCF)|Participants' parent or guardian maintained a seizure diary recording the date, number,and type of seizures the subject had. Seizure frequency of simple partial,complex partial,and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0) and Week 8 to Week 20|ITT Population||Percentage Change in Seizure Frequency||Full Range|Median
128292|NCT00566254|Primary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Maintenance Period(LOCF)|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. The primary analysis assessed the percent of responders in the Maintenance Period (28- day seizure frequency in Week 8 to Week 20 compared to Week -8 to Week 0 at Last Observation Carried Forward (LOCF)). Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline (Week -8 to Week 0), and Week 8 to Week 20|The Intent to Treat (ITT)Population was defined as the group of randomized subjects who received at least one does of doubleblind study medication||Percentage of Participants|||Number
128293|NCT00566150|Secondary|Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.|Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.||score on scale||Standard Error|Least Squares Mean
128294|NCT00566150|Secondary|Number of Subjects Who Achieve Remission.|"Remission response is measured as an HDRS-21 total score is less than or equal to 7.~HDRS-21 measures range of depressive symptoms. Endpoint is LOCF."|Week 6|||Participants|||Number
128295|NCT00566150|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.||score on scale||Standard Error|Least Squares Mean
128296|NCT00566150|Primary|Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.|Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to week 6|Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.||score on scale||Standard Error|Least Squares Mean
128297|NCT00566111|Secondary|Change in Ratings on the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP).|The number of patients that had a decrease on CGI-BP at 4 weeks.|4 weeks|only patients with complete data at 4 weeks were analyzed||participants|||Number
128298|NCT00566111|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)Score From Baseline.|The number of patients that had a decrease on MADRS at 4 weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed||participants|||Number
128299|NCT00566111|Secondary|Number of Subjects Who Achieve Remission as Defined by a HDRS Score < 7.||4 weeks|only participants with complete data at 4 weeks were analyzed||participants|||Number
128300|NCT00566111|Secondary|Change in Score on the 16-item Quick Inventory of Depressive Symptoms (QIDS) From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|These data were not collected.|||||
128301|NCT00566111|Primary|Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline.|Number of patients with scores that decreased at four weeks.|4 weeks|only participants with complete data at 4 weeks were analyzed||participants|||Number
128397|NCT00565604|Primary|Primary Effectiveness Objective|The primary objective is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated incompetent perforated vein [IPV])) of endovenous laser ablation. The number of treated IPVs that are closed at 6 weeks and remain closed at 6 months.|6 Months|The number of patients still participating in the study at 6-months.||Treated IPVs|Participants||Number
128302|NCT00566020|Secondary|Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants without concomitant use of inhibitor and inducer from the date of the first dose of study medication to the date of the last dose. Multiple blood samplings were conducted for some participants. A total of 82 participants were analyzed; 4 participants did not have 200 mg dose data but had data for lower doses.||Nanograms per milliliter||Full Range|Median
128303|NCT00566020|Secondary|Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)|PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants (par.) who took at least one dose of drugs that inhibit lamotrigine glucuronidation (i.e., valproate) from the date of the first dose of study medication to the date of the last dose. A total of 8 par. were analyzed; 1 par. had both 100 and 200 mg data, 4 par. had 100 mg data only, and 3 par. had 200 mg data only.||Nanograms per milliliter||Full Range|Median
128304|NCT00566020|Secondary|Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)|Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.|from Week 6 to Week 52/EW|Safety Population. Participants who took at least one dose of drugs that induce lamotrigine glucuronidation (e.g., carbamazepine) from the date of the first dose of study medication to the date of the last dose.||Nanograms per milliliter||Full Range|Median
128305|NCT00566020|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
128306|NCT00566020|Secondary|Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW|"The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the best rating and 4 or 8 is the worst rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst)."|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
128307|NCT00566020|Secondary|Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
128308|NCT00566020|Secondary|Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill).|Weeks 6, 16, 28, 40, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
128309|NCT00566020|Secondary|Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||scores on a scale||Standard Deviation|Mean
128310|NCT00566020|Secondary|Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).|Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Full Analysis Set (FAS): participants who received >=1 dose of study medication and underwent >=1 efficacy assessment. Observed Cases (OC; observed data with no imputation) and Last Observation Carried Forward (LOCF; data imputed [replaced] by most recent observed value [compared to planned date of missing observation]) were used for analysis.||scores on a scale||Standard Deviation|Mean
128311|NCT00566020|Primary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW|ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.|Weeks 0, 6, 28, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128312|NCT00566020|Primary|Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||Kilograms per meters squared||Standard Deviation|Mean
128313|NCT00566020|Primary|Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|The weight of participants was recorded at the indicated time points.|Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||kilograms||Standard Deviation|Mean
128314|NCT00566020|Primary|Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Heart rate was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||beat per minute||Standard Deviation|Mean
128315|NCT00566020|Primary|Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Systolic and diastolic blood pressure was measured in participants at the indicated time points.|Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||Millimeters of mercury||Standard Deviation|Mean
128316|NCT00566020|Primary|Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG [-]), trace (TRA [+/-]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128317|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Red blood cell count was measured in participants at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10^12)/L, Female: 3.76-5.16 TI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128318|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128319|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128320|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter [MMOL/L]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128321|NCT00566020|Primary|Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128322|NCT00566020|Primary|Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)|"Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as High for laboratory values above normal (reference) and as Low for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L."|Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)|Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).||participants|||Number
128323|NCT00566020|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)|Safety Population: all participants who received at least one dose of study medication||participants|||Number
128324|NCT00565812|Other Pre-specified|Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96||Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||beats per minute (bpm)||Standard Deviation|Mean
128325|NCT00565812|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant’s same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||mmHg||Standard Deviation|Mean
128326|NCT00565812|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96|Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant’s same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.|Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96|The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||millimeters of mercury (mmHg)||Standard Deviation|Mean
128327|NCT00565812|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN), platelet: <0.5*LLN or greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil:<0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine:>1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, lipase >1.5*ULN; urine (specific gravity <1.003 or >1.030, pH <4.5 or >8, glucose, ketones, protein, blood/Hgb greater than or equal to [>=]1); pancreatic amylase >1.5*ULN.|Baseline up to Week 111|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
128426|NCT00565409|Secondary|Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36|"General Health VAS is a 100 millimeter (mm) line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Baseline observation."|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||mm||Standard Deviation|Mean
128328|NCT00565812|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than [>]140 milliseconds [msec]), junctional/paced rhythm, intraventricular conduction delay (>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.|Baseline, Month 3, 6, 12, 18, 24|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128329|NCT00565812|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 7-10 days after last dose of study drug (Week 111)|The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication.||participants|||Number
128330|NCT00565812|Secondary|Number of Participants Applicable for Virtual Joint Replacement|A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
128331|NCT00565812|Secondary|Number of Participants With Joint Space Narrowing Progression|JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
128332|NCT00565812|Secondary|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index|The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 [minimum] to 20 [maximum], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 [minimum] to 68 [maximum], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 [minimum] to 5 [maximum], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||participants|||Number
128333|NCT00565812|Secondary|Patient Global Impression of Change Score|Patient global impression of change was a participant-rated instrument that measured change in participant’s overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.|Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.||units on a scale||Standard Deviation|Mean
128334|NCT00565812|Secondary|Number of Participants With Decrease in Total Analgesic Medication Use|Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128335|NCT00565812|Secondary|Number of Participants With Increase in Total Analgesic Medication Use|Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.|Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128336|NCT00565812|Secondary|EuroQoL-5D Visual Analog Scale Score|The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128411|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and C-Reactive Protein CRP.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128337|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128338|NCT00565812|Secondary|Number of Participants With EuroQo-5D Pain and Discomfort Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128339|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Usual Activity Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128340|NCT00565812|Secondary|Number of Participants With EuroQoL-5D Self-Care Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128341|NCT00565812|Secondary|Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||participants|||Number
128342|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128343|NCT00565812|Secondary|Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128344|NCT00565812|Secondary|Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128345|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128346|NCT00565812|Secondary|Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128347|NCT00565812|Secondary|Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128348|NCT00565812|Secondary|Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128349|NCT00565812|Secondary|Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128350|NCT00565812|Secondary|Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128351|NCT00565812|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24|The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.|Baseline, Month 12, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128352|NCT00565812|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score – Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24|The KOOS-PS was used to rate participant’s opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128353|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24|The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128354|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128355|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24|The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128356|NCT00565812|Secondary|Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24|The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluated for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128357|NCT00565812|Secondary|Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24|The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128358|NCT00565812|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|Physician assessed the overall impact of arthritis on the participant’s daily life. Participant’s condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128359|NCT00565812|Secondary|Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition."|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128360|NCT00565812|Secondary|Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24|Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||mm||Standard Deviation|Mean
128361|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128456|NCT00565266|Secondary|Biomarkers of Inflammation and Oxidative Stress||Measured during each of the three 14-week treatment periods||||||
128457|NCT00565266|Secondary|Asthma Exacerbations||Measured during each of the three 14-week treatment periods||||||
128362|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24|Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128363|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24|The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128364|NCT00565812|Secondary|Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24|The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.|Baseline, Month 3, 6, 12, 18, 24|FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.||units on a scale||Standard Deviation|Mean
128365|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG =3 and evaluable for this outcome measure.||mm/year||Standard Deviation|Mean
128366|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2|Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 [no severity] to 4 [maximum severity], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG <=2 and evaluable for this outcome measure.||mm/year||Standard Deviation|Mean
128367|NCT00565812|Primary|Rate of Progression of Joint Space Narrowing|Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.|Baseline up to Month 24|FAS included all participants randomized to the study. Here, 'number of participants analyzed' (N) signifies participants evaluable for this outcome measure.||mm/year||Standard Deviation|Mean
128368|NCT00565747|Secondary|Live Birth|Subject having at least one live birth. Including a foetus which breathes or shows any other evidence of life after expulsion/extraction from its mother. The definition is independent of the duration of the pregnancy (ICMART/WHO criteria).|Until 7 days after birth|PP-population||percentage of transfer patients|||Number
128369|NCT00565747|Secondary|Number of Top Quality Embryos (TQE´s)|Number of 4-5 cell embryo at 44 hours,at least 7 cell embryo at 68 hours, maximum 20% fragmentation, equally large blastomeres (less than 25% difference in size),No signs of multinucleation. Calculated in percentage of number of 2 pronuclei (2PN) oocytes.|3 days from oocyte pick-up|PP-population||percentage of 2PN's|||Number
128370|NCT00565747|Primary|Ongoing Implantation Rate Week 7|Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.|Approximately 5 weeks from oocyte pick-up (corresponding to 7 weeks from ovulation)|PP-population||percentage of transferred embryos|Participants||Number
128371|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128372|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128373|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128374|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128375|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128376|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128377|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128378|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128379|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128380|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).||Correlation coefficient||95% Confidence Interval|Number
128381|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.~Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC.~SUVR_55_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128412|NCT00565409|Secondary|Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128458|NCT00565266|Secondary|Asthma Control, Asthma Quality-of-life||Measured during each of the three 14-week treatment periods||||||
128382|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.~SUVw_55 is the standard uptake value at 55 minutes post-injection, normalized to weight."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128383|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128384|NCT00565721|Secondary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation.~Two (2) of the 22 subjects did not have any αvβ5 integrin results."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128385|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.~The Logan plot is the counterpart of the Patlak plot for reversible radiotracers."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128386|NCT00565721|Primary|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)|"Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation.~Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake."|Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.|This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.||Correlation coefficient||95% Confidence Interval|Number
128387|NCT00565643|Secondary|Operative Times at Subsequent Delivery|Amount of time spent at the time of the subsequent delivery|3 to 5 years|||minutes||Full Range|Median
128388|NCT00565643|Secondary|Post-operative Maximum Temperature Following Randomization|Maximum temperature of patient, >24 hours following randomization delivery|1 to 5 years|||degrees Fahrenheit||Standard Deviation|Mean
128389|NCT00565643|Secondary|Post-Operative Complications|Percentage of patients experiencing any of the predefined post-operative complications following randomization|1 to 5 years|||% of patients experiencing complication|||Number
128390|NCT00565643|Secondary|Post-operative White Blood Cell Count|Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups|1 to 5 years|||cells/mm^3||Standard Deviation|Mean
128391|NCT00565643|Primary|Adhesion Score|Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).|3 to 5 years|||units on a scale||Full Range|Median
128392|NCT00565643|Secondary|Post-operative Hemoglobin|Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups|1 to 5 years|||% of blood that is red blood cells||Standard Deviation|Mean
128393|NCT00565643|Primary|Incidence of Adhesions|The Percentage of participants with one or more adhesions, regardless of the extent or severity|3 to 5 years|||percentage of patients with adhesions|||Number
128394|NCT00565604|Secondary|Secondary Safety Objective|Safety: Incidence rate of device-related minor adverse events.|6 Months|The number of subjects that were enrolled in the trial.||Participants|||Number
128395|NCT00565604|Secondary|Secondary Effectiveness Objective|Effectiveness: The reduction in patient symptoms and the satisfaction of the patient. Patient symptom assessment - CEAP Class, best=0 (no visible or palpable signs of venous disease) & worst=6 (Skin changes in conjunction with active ulceration), VDS, best=0 (asymptomatic) & worst=3 (unable to carry out usual activities even with compression and/or limb elevation) and VCSS, best=0 (absent) & worst=3 (severe). Patient satisfaction - modified Odom’s criteria, best=excellent (I am very satisfied with the results of my laser treatment) & worst=poor (I am not satisfied with the results).|6 Months|The number of patients still participating in the study at 6-months.||Participants|||Number
128396|NCT00565604|Primary|Primary Safety Objective|Safety: Evaluation of occurrence of major device-related adverse events through 6 weeks and the total at 6 months.|6 Months|The number of patients that were enrolled in the study.||Participants|||Number
128459|NCT00565266|Secondary|Asthma Symptoms, Number of Asthma-control Days, Rescue Inhaler Use||Measured during each of the three 14-week treatment periods||||||
128398|NCT00565461|Primary|Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA"|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology||percentage of study participants||95% Confidence Interval|Number
128399|NCT00565461|Primary|GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data."|Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology||geometric mean fold ratio||95% Confidence Interval|Number
128400|NCT00565461|Secondary|Safety and Evaluation of Immunogenicity for Self-administration In-clinic Compared to Self-administration Away From the Clinic.||6 months||||||
128401|NCT00565461|Secondary|Evaluation of Immunogenicity for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.||6 months||||||
128402|NCT00565461|Secondary|Safety of Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch||6 months||||||
128403|NCT00565461|Primary|GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.|"The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen.~GMT: geometric mean titer"|Day 0, Day 14, Day 21, Day 28, Day 35, Day 194|intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology||geometric mean titers||95% Confidence Interval|Geometric Mean
128404|NCT00565448|Secondary|Overall Survival (OS) Rate|OS rate is the percentage of participants who survived 3 years after completion of consolidation treatment period. The Kaplan-Meier method was used to estimate OS rate.|3 years after the end of the consolidation treatment period (up to 40 months from randomization)|ITT population: all randomized participants.||percentage of participants||95% Confidence Interval|Number
128405|NCT00565448|Secondary|Overall Response (OR)|OR is classified as CR, partial response (PR), stable disease (SD), progressive disease (PD) or Unknown on completion of both induction and radiation treatment and assessed according to the Modified RECIST from the NCI. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as ≥30% decrease in the sum of the longest diameters (LD) of TLs, taking as reference the disease measurement done at study entry. PD is defined as ≥20% increase in the sum of the LD of TLs, taking as a reference the smallest disease measurement recorded at study entry or the appearance of ≥1 new lesions or unequivocal progression of non-TLs. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|after the completion of the consolidation treatment (up to 18 weeks)|ITT population: all randomized participants.||participants|||Number
128406|NCT00565448|Secondary|Docetaxel Area Under the Plasma Concentration-time Curve (AUC) in the Docetaxel/Cisplatin/5-FU Group|AUC estimated by Bayesian method using concentration–time data for each participant and the previously defined adult population model as prior information (with validity of the estimation verified).|Three plasma samples: one just before then 45 minutes and 5hour after the end of cycle 1 infusion|Participants who were randomized to docetaxel/cisplatin/5-FU and had evaluable docetaxel pharmacokinetic (PK) sample.||µg*h/mL||Standard Deviation|Mean
128407|NCT00565448|Primary|Number of Participants With Complete Response (CR)|CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.|after the completion of the induction treatment (up to 9 weeks)|ITT population: all randomized participants.||participants|||Number
128408|NCT00565409|Secondary|DAS28 at Week 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm).|Week 36|P2 mITT; LOCF||units on a scale||Standard Error|Mean
128409|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR90 response: ≥ 90% improvement in tender joint count; = 90% improvement in swollen joint count; and = 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||percentage of participants|||Number
128410|NCT00565409|Secondary|Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR90 response: ≥ 90% improvement in tender joint count; = ≥90% improvement in swollen joint count; and = at least 90% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; LOCF||percentage of participants|||Number
128460|NCT00565266|Secondary|Forced Expiratory Volume in One Second (FEV1)||Measured during each of the three 14-week treatment periods||||||
128413|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128414|NCT00565409|Secondary|Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36|ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128415|NCT00565409|Secondary|Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88|ACR20 response: ≥ 20% improvement in tender joint count; ≥20% improvement in swollen joint count; and = at least 20% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data||percentage of participants|||Number
128416|NCT00565409|Secondary|Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36|ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR).|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128417|NCT00565409|Secondary|Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Week 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128418|NCT00565409|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36|EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.|Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128419|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Weeks 36, 64 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||percentage of participants|||Number
128420|NCT00565409|Secondary|Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36|PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).|Baseline, Week 36|P1 mITT; N=number of participants with evaluable data; LOCF||percentage of participants||95% Confidence Interval|Number
128421|NCT00565409|Secondary|Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||mm||Standard Error|Least Squares Mean
128422|NCT00565409|Secondary|Pain at Week 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = pain as bad as it could be. Change = Week x observation minus (-) Baseline observation.|Week 36|P2 mITT; LOCF||mm||Standard Error|Mean
128423|NCT00565409|Secondary|Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36|100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation – Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||mm||Standard Error|Mean
128424|NCT00565409|Secondary|Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88|"General Health VAS is a 100 mm line marked by the participant. Participants were asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Week 36 observation."|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF||mm||Standard Error|Least Squares Mean
128425|NCT00565409|Secondary|General Health at Week 36|"General Health VAS is a 100 mm line marked by the participant. Participants are asked, In general how would you rate your health over the last 2 to 3 weeks? Scores ranged from 0 mm = very well to 100 mm = extremely bad."|Week 36|P2 mITT; LOCF||mm||Standard Error|Mean
128461|NCT00565266|Primary|Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)||AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.|All randomized participants were included in the linear mixed-effects model analysis||Liters per minute||Standard Error|Least Squares Mean
128427|NCT00565409|Secondary|Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; N=number of participants with evaluable data; LOCF||min||Standard Error|Least Squares Mean
128428|NCT00565409|Secondary|Duration of Morning Stiffness at Week 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded.|Week 36|P2 mITT; N=number of participants with evaluable data; LOCF||min||Standard Error|Mean
128429|NCT00565409|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour times [*] 60 min) was recorded. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||minutes (min)||Standard Deviation|Mean
128430|NCT00565409|Secondary|Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80, 88|P2 mITT; LOCF||units on a scale||Standard Error|Least Squares Mean
128431|NCT00565409|Secondary|PtGA of Arthritis Pain at Week 36|PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity).|Week 36|P2 mITT; LOCF||units on a scale||Standard Error|Mean
128432|NCT00565409|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36|Participants asked to rate their overall arthritis activity by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||units on a scale||Standard Error|Mean
128433|NCT00565409|Secondary|Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||units on a scale||Standard Error|Least Squares Mean
128434|NCT00565409|Secondary|PGA Score at Week 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.|Week 36|P2 mITT; LOCF||units on a scale||Standard Error|Mean
128435|NCT00565409|Secondary|Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36|PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||units on a scale||Standard Error|Mean
128436|NCT00565409|Secondary|Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|Total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Weeks 36 40, 48, 56, 64, 72, 80 and 88|P2 mITT; N=number of participants with evaluable data; LOCF||number of painful joints||Standard Error|Least Squares Mean
128437|NCT00565409|Secondary|Painful Joint Count at Week 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28.|Week 36|P2 mITT; LOCF||number of painful joints||Standard Error|Mean
128438|NCT00565409|Secondary|Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36|A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||number of painful joints||Standard Error|Mean
128439|NCT00565409|Secondary|Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.|Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF||number of swollen joints||Standard Error|Least Squares Mean
128440|NCT00565409|Secondary|Prorated Swollen Joint Count at Week 36|ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by number of non-missing swollen joints). Total possible score of swollen joints ranged from 0-28.|Week 36|P2 mITT; LOCF||number of swollen joints||Standard Error|Mean
128441|NCT00565409|Secondary|Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36|American College of Rheumatology (ACR), swollen joint count were an assessment of 28 joints. Joints are classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation – baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; N=number of participants with evaluable data; LOCF||number of swollen joints||Standard Error|Mean
128442|NCT00565409|Secondary|Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88|DAS28 calculated from the number of SJC and PJC using the 28 joints, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 < 3.2 units = low disease activity. Cumulative proportion calculated as time-averaged Area Under the Curve (AUC) (AUC divided by number of weeks at that time point), with AUC calculated from Week 36 and Week 88.|Week 36 up to Week 88|P2 mITT; LOCF||proportion of weeks in DAS28 <3.2||Standard Error|Mean
128443|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 greater than (>)3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;||days||95% Confidence Interval|Median
128444|NCT00565409|Secondary|Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. Low disease activity = DAS28 ≤ 3.2 units. DAS28 > 3.2 to 5.1 units = moderate to high disease activity.|Week 36 up to Week 88|P2 mITT;Imputation of failure; observed cases||days||95% Confidence Interval|Median
128445|NCT00565409|Secondary|Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|P2 mITT; LOCF; N=number of participants with evaluable data||units on a scale||Standard Error|Least Squares Mean
128446|NCT00565409|Secondary|Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient’s global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.|Baseline, Weeks 4, 8, 12, 20, 28 and 36|P1 mITT; Last observation carried forward (LOCF); N=Number of participants with evaluable data||units on a scale||Standard Error|Mean
128447|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Weeks 36, 40, 48, 56, 64, 72, 80 and 88|Period 2 (P2) mITT||Percentage of participants|||Number
128448|NCT00565409|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.|Baseline, Weeks 4, 8, 12, 20, 28, 36|Period 1 Modified Intent to Treat population (P1 mITT): all participants who took at least 1 dose of open-label test article; N=number of participants with evaluable data; Last observation carried forward (LOCF)||percentage of participants|||Number
128449|NCT00565409|Primary|Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than [<]20 percent [%] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity.|Week 88|Modified Intent to Treat population (mITT): all participants who took at least 1 dose of double-blind test article and had at least 1 post-randomization DAS28 evaluation||percentage of participants|||Number
128450|NCT00565370|Secondary|Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib|28weeks|||participants|||Number
128451|NCT00565370|Secondary|Overall Survival||28 months|||Months||95% Confidence Interval|Median
128452|NCT00565370|Secondary|Response Rate|"Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate"|6 months|Patients who had measurable lesions were included for the response rates||percentage of participants||95% Confidence Interval|Number
128453|NCT00565370|Primary|Progression-free Survival||1 year|||Months||95% Confidence Interval|Median
128454|NCT00565370|Primary|Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)|Number of Participants who Experienced Dose Limiting Toxicities (DLTs)|28weeks|||participants|||Number
128455|NCT00565266|Secondary|Adverse Events||Measured during each of the three 14-week treatment periods||||||
128462|NCT00565136|Other Pre-specified|Pudendal Nerve Terminal Motor Latency|Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both.|Baseline (pre-treatment), 6 Month post-treatment|||msec||Standard Deviation|Mean
128463|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Tolerable Volume||Baseline (pre-treatment), 6 Month post-treatment|||cc||Standard Deviation|Mean
128464|NCT00565136|Other Pre-specified|Anal Manometry: Rectal First Sensation||Baseline (pre-treatment), 6 Month post-treatment|||cc||Standard Deviation|Mean
128465|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Squeeze Pressure||Baseline (pre-treatment), 6 Month post-treatment|||mmHg||Standard Deviation|Mean
128466|NCT00565136|Other Pre-specified|Anal Manometry: Maximum Resting Pressure||Baseline (pre-treatment), 6 Month post-treatment|||mmHg||Standard Deviation|Mean
128467|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure||Duration of the device implant procedure (an average of 23 minutes)|All enrolled/implanted subjects were included in this analysis||ml||Standard Deviation|Mean
128468|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Hospital Stay||Length of the hospital stay for the device implant procedure|All enrolled/implanted subjects were included in this analysis||hours||Standard Deviation|Mean
128469|NCT00565136|Secondary|Intra- and Peri-Surgical Parameters: Length of Procedure||Duration of the device implant procedure|All enrolled/implanted subjects were included in this analysis||minutes||Standard Deviation|Mean
128470|NCT00565136|Secondary|Pain Intensity as Measured by the Pain Intensity Scale|The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.|Baseline (pre-treatment), 6 Week post-treatment|"The Pain Intensity Scale was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29"||units on a scale||Standard Deviation|Mean
128471|NCT00565136|Secondary|Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life|The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.|Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Fecal Incontinence Quality of Life Assessment was completed by the number of subjects at each visit as follows:~Baseline: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"||units on a scale||Standard Deviation|Mean
128472|NCT00565136|Post-Hoc|Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline|Includes solid and liquid stools, as measured by a subject-reported bowel diary|6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"Two subjects were enrolled who recorded no FI episodes at baseline and were excluded from this analysis. Missing data was not imputed and was considered a treatment failure.~The Bowel Diary was completed by the number of subjects at each visit as follows:~6 Week: N=24, 3 Month: N=25, 6 Month: N=22, 12 Month: N=21, 24 Month: N=24"||percentage participants||90% Confidence Interval|Number
128473|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence|The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1–6, 7–10, and 11–13 were categorized as mild, moderate, and severe fecal incontinence, respectively.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Symptom Severity Scale in Fecal Incontinence was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"||units on a scale||Standard Deviation|Mean
128474|NCT00565136|Secondary|Fecal Incontinence Symptoms as Measured by the Wexner Score|The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The Wexner Score was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23"||units on a scale||Standard Deviation|Mean
128475|NCT00565136|Secondary|Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period|Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)|Through 24 month post-treatment|Includes all subjects implanted with the TOPAS device||events per 24 months/participant|||Number
128476|NCT00565136|Primary|Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment|Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.|Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment|"The FI Bowel Diary was completed by the number of subjects at each visit as follows:~Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26"||Number of FI episodes/14 day period||Standard Deviation|Mean
128477|NCT00565084|Primary|Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks|"Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk.~Change from baseline was average of post-dose PIs minus average of pre-dose PI."|All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)|This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods.||Units on a Scale||Standard Deviation|Least Squares Mean
128478|NCT00565058|Secondary|Summary of Treatment Emergent Adverse Events|An adverse event (AE) was defined as any unintended or undesirable experience that occurred during the course of the clinical investigation, regardless of whether or not it was considered to be study drug-related. This included any newly occurring event or a previous condition that had increased in severity or frequency since the administration of study drug.|30 days after the last dose|All Treated Patients population.||participants|||Number
128479|NCT00565058|Primary|Overall Response Rate of GTI-2040 Combined With HiDAC in Refractory or Relapsed AML|Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.|at 29-35 days|All Treated Patients population||participants|||Number
128480|NCT00565045|Secondary|Fugl-Meyer Assessment (Upper Extremity)|The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better).|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.||units on a scale||Standard Error|Mean
128481|NCT00565045|Secondary|Arm Motor Abilities Test|The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn’t participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5.|3 months post-treatment.|The participants who completed the 6-week treatment phase were analyzed.||units on a scale||Standard Error|Mean
128482|NCT00565045|Secondary|Box and Blocks Score|The number of blocks picked up and moved across a barrier in 60 seconds|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.||blocks||Standard Error|Mean
128483|NCT00565045|Secondary|Finger Tracking Error|A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.||% AROM||Standard Error|Mean
128484|NCT00565045|Primary|Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)|A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger.|3 months post-treatment.|The participants who completed the 6-week treatment phase were included in the analysis.||degrees||Standard Error|Mean
128485|NCT00564954|Primary|Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0 hr and 0.5 hr post-dose|Intent to Treat (ITT) population: All randomized patients who had at least one dose of study medication and who had at least one post-dose efficacy measurement.||score on a scale||Standard Error|Least Squares Mean
128486|NCT00564954|Secondary|Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test|Number of math questions answered correctly within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.||questions correct||Standard Error|Least Squares Mean
128487|NCT00564954|Secondary|Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test–Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)|Number of math questions attempted within a 10 minute period.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population||questions attempted||Standard Error|Least Squares Mean
128488|NCT00564954|Secondary|Change From Pre-dose in SKAMP Deportment Score|SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.|0, 0.5, 1, 2, 4, 6 and 8 hours|Intent to Treat (ITT) population.||score on a scale||Standard Error|Least Squares Mean
128489|NCT00564954|Secondary|Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)|SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.|0, 0.5, 1, 2, 4, 6, and 8 hours|Intent to Treat (ITT) population||score on a scale||Standard Error|Least Squares Mean
128490|NCT00564954|Secondary|Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)|SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.|0, 1, 2, 4, 6, and 8 hr|Intent to Treat (ITT) population||score on a scale||Standard Error|Least Squares Mean
128521|NCT00564850|Secondary|Follicle Stimulating Hormone (FSH) Level Following GnRH Test||Screening, month 3 and 6|Analysis was performed on the ITT population. 3 participants and 2 participants had missing data at month 3 and month 6 respectively.||IU/L||Standard Deviation|Mean
128491|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering light emitting diodes and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated.|12 months|All participants in all arms were tested||Density units of Macular Pigment (du)||Standard Error|Mean
128492|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|8 months|All participants in all arms were tested||Density units of Macular Pigment (du)||Standard Error|Mean
128493|NCT00564902|Secondary|100% Kinetic Field|Scotomas within the central 20 degree central macula visual field sensitivity was assessed at 5 contrast levels (20, 40, 60, 80, and full contrast). A yellow wavelength stimulus avoided confounding by the lens. Subjects outlined the boundaries of their scotoma(s) on an area-integrating and recording touch flat- screen RGB monitor displaying a central fixation point and movable horizontal/vertical raster lines. The computer calculated summed area of the scotoma(s) with arbitrary scaling from 6000 (dense scotoma) to 0 relative units (absence of scotoma).|12 Months|Eyes of all patients still in the trial were measured||Units on a scale (0 to 6000)||Standard Error|Mean
128494|NCT00564902|Secondary|6.5 Degrees Tritan Threshold|The ChromaTest© is a computerized psychophysical test of protan and tritan color thresholds against age-corrected data. The computer finds the endpoint of the test by a Modified Binary Search method; if response is correct, on the next presentation the color difference between letter and background is halved. If response is incorrect, the color -contrast is doubled. Incorrect responses prolong the test, but do not influence the final threshold. This method of determining thresholds leads to finite steps which reach a plateau at the color contrast sensitivity threshold.|12 months|Eyes of all patients still in the trial were measured||dB||Standard Error|Mean
128495|NCT00564902|Secondary|Contrast Sensitivity Function Photopic Distance|Distance photopic contrast sensitivity function (CSF) at 5 spatial frequencies (1.5, 3, 6, 12 & 20 cc/deg) was determined with the Functional Vision Analyzer® (Stereo Optical Co, Inc, Chicago, IL). Contrast sensitivity readings are shown as a curve. Visual acuity is plotted along the horizontal axis and contrast sensitivity along the vertical axis. Among the normally sighted people, both visual acuity and contrast sensitivity have a wide range of variation.Low population CSF is 0-200 units; normal population CSF is 200-300 units and suprathreshold CSF is 300+ units.|12 Months|Eyes of all patients still in the trial were measured||units on a scale||Standard Error|Mean
128496|NCT00564902|Secondary|Glare Recovery|Photostress glare recovery test involves exposing an individual eye to intense light, or retinal bleach, for a set duration of time and measuring the time taken for visual acuity to recover to a predetermined level. Glare photo-stress recovery (in seconds) following 30 seconds of continuous retinal bleach, was assessed using 2 line supra-threshold low contrast randomly presented Landolt Cs using the KOWA AS14B Night Vision Tester (KOWA Optimed, Tokyo, Japan).|12 Months|Eyes of all patients still in the trial were measured||Seconds||Standard Error|Mean
128497|NCT00564902|Secondary|Early Treatment Diabetic Retinopathy Study Distance Visual Acuity|Black and 10% contrast near reading visual acuity was assessed with a Colenbrander Mixed Contrast Reading Card with LogMAR letters (#4031, Precision Vision, LaSalle, Illinois). We determined single letter acuity on an ordinal VAS (Visual Acuity Scale). The largest letters were 0.05 LogMAR with a VAS = 35 while the most difficult smallest letters were LogMar 1.25 or VAS 105. The test card was held at 40 cm with best monocular refraction, and both low and high contrast letter acuity were assessed.|12 months|Eyes of all patients still in the trial were measured||units on a scale||Standard Error|Mean
128498|NCT00564902|Secondary|SHAPE Discrimination|We determined the target deformation detection thresholds, or amplitude of the minimum detectable distortion of a 1 degree foveal circular target. The peak spatial frequency of RF (radial frequency) patterns was 5 cyc/deg; the radial modulation frequency was 8 cyc/360°; mean radii were 0.5°, 1°, 2.0°, or 2.5°; and stimulus contrast was 80%. The highest % modulation score possible is 0.13 while the easiest (lowest score) was 10% modulation.|12 months|Eyes of all participants still in the trial were measured||% modulation||Standard Deviation|Mean
128499|NCT00564902|Primary|Macular Pigment Optical Density|Replicate measures of foveal 1 degree estimated central MPOD were evaluated with the Quantify® MPS 9000 macular pigment screener, a modified heterochromic flicker photometer (HFP). It employs alternating blue and green flickering LED's and fixation on a 1 degree target, so that a representative measurement at 0.5 degree off center from the fovea is calculated. The method has good repeatability (r = 0.97) and the data are comparable with an objective optical method based on retinal reflectometry (r = 0.78).|4 months|All participants in all arms were tested||Density units of Macular Pigment (du)||Standard Error|Mean
128500|NCT00564889|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)|||months||95% Confidence Interval|Median
128501|NCT00564889|Secondary|Progression Free Survival (PFS)|Progression free survival (PFS) was defined as the time from registration to hematologic progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 3 years)|||months||95% Confidence Interval|Median
128502|NCT00564889|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Duration of study (up to 3 years)|||participants|||Number
128522|NCT00564850|Secondary|Number of Participants Whose Intravenous (i.v.) GnRH-stimulated LH Response Was ≤3 IU/L||Month 6|"Analysis was performed on Intention to Treat population (ITT) defined as all participants having received at least one injection of 11.25 mg triptorelin pamoate. n indicates the number of patients who had an assessment at the visit."||participants|||Number
128503|NCT00564889|Secondary|Number of Patients With Organ Response|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|Duration of study (up to 3 years)|||participants|||Number
128504|NCT00564889|Primary|Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)|"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration on study (up to 3 years)|||participants|||Number
128505|NCT00564876|Secondary|Safety and Tolerability of Adjuvant Dasatinib|Determine the safety and tolerability of adjuvant dasatinib in early stage NSCLC.|Duration of adjuvant treatment plus 30 days.|Due to insufficient accrual, data analysis was not performed.|||||
128506|NCT00564876|Secondary|Gene Expression Profile Activation of Src Pathways|Determine whether gene expression profile activation of Src pathways is correlated with anti-tumor activity of dasatinib in early stage NSCLC.|Baseline and after 3 weeks of dasatinib therapy at the time of definitive surgical resection.|Due to insufficient accrual, data analysis was not performed.|||||
128507|NCT00564876|Secondary|Safety and Tolerability of Neoadjuvant Dasatinib|Determine the safety and tolerability of neoadjuvant dasatinib in early stage NSCLC.|Screening / Baseline; Neoadjuvant dasatinib Cycle 1 Day 1 and Day 22|Due to insufficient accrual, data analysis was not performed.|||||
128508|NCT00564876|Primary|Response Rate|Response rate (radiologic and pathologic) in Stage IB and II to neoadjuvant dasatinib|First progression and survival every 3 months for 2 years, then every 6 months until 5 years, then yearly.||||||
128509|NCT00564850|Secondary|Triptorelin Plasma Levels||Month 1, 2, 3, 4, 5 and 6|Analysis was performed on the Pharmacokinetics (PK) Valid population defined as all participants who received at least one injection of 11.25 mg triptorelin pamoate and had at least one PK assessment. 2 participants had data missing at month 1,3 and 6. 1, 3 and 4 participants had data missing at month 2, 4 and 5 respectively.||ng/mL||Standard Deviation|Mean
128510|NCT00564850|Secondary|Uterine Length||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and 6.||mm||Standard Deviation|Mean
128511|NCT00564850|Secondary|Difference Between Bone Age and Chronological Age|Bone age was defined according to Greulich and Pyle method. Chronological age was calculated using the date of birth.|Month 0 and 6|Analysis was performed on the ITT population. 33 participants were assessed. 4 participants had missing data at month 6.||years||Standard Deviation|Mean
128512|NCT00564850|Secondary|Change From Baseline in Growth Velocity (GV) SDS at Month 6|"Change from baseline of GV was calculated as: GV at month 6 - GV at baseline. GV SDS was calculated using SAS algorithm.~Growth velocity during the study was calculated using the two height measures as: GV = (Height at baseline - Height at screening)*365/delay between two height measures."|Baseline and month 6|Analysis was performed on the ITT population. If GV at screening was missing, the value was derived from data recorded between 5 to 19 months ago otherwise GV at screening was considered missing. 9 participants had missing data.||SD score||Standard Deviation|Mean
128513|NCT00564850|Secondary|Body Mass Index (BMI) SDS||Month 0, 3 and 6|Analysis was performed on the ITT population. 1 and 2 participants had missing data at month 0 and month 6 respectively.||SD score||Standard Deviation|Mean
128514|NCT00564850|Secondary|Height Standard Deviation Score (SDS)|Standard deviation (SD) is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.|Month 0, 3 and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 6.||SD score||Standard Deviation|Mean
128515|NCT00564850|Secondary|Change From Screening in Pubertal Stage (Tanner Method) at Month 6|Pubertal stage (graded from 1 to 5 for penis and breast development, graded from 1 to 6 for pubic hair development) according to the Tanner method was collected. A low stage (i.e. 1) corresponds to a pre-pubertal stage and a high stage (i.e. 5 or 6) to an adult stage. Any increase of grade was defined as 'increased' and no change in grade or a reduced grade was defined as 'stabilised or reduced'.|Between screening and month 6|Analysis was performed on the ITT population. 2 participants had missing data for pubic hair stage and breast stage.||participants|||Number
128516|NCT00564850|Secondary|Number of Girls With Inhibin B Levels < 6 pg/ml||Month 0, 3 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 3 and month 6.||participants|||Number
128517|NCT00564850|Secondary|Testosterone Level||Month 0, 3 and 6|Testosterone level from the male patient in the ITT population.||ng/ml|||Number
128518|NCT00564850|Secondary|Number of Girls With Oestradiol Levels ≤ 20 pg/ml||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on female patients in the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 participant and 3 participants had missing data at month 2 and 5 respectively.||participants|||Number
128519|NCT00564850|Secondary|Basal LH Level||Month 0, 1, 2, 3, 4, 5 and 6|Analysis was performed on ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.||IU/L||Standard Deviation|Mean
128520|NCT00564850|Secondary|Basal FSH Level||Month 0, 1, 2, 3, 4, 5, and 6|Analysis was performed on the ITT population. 2 participants had missing data at month 1, 3, 4 and 6. 1 and 3 participants had missing data at month 2 and month 5 respectively.||IU/L||Standard Deviation|Mean
128523|NCT00564850|Primary|Number of Participants With a GnRH-stimulated LH Level ≤3 IU/L||3 months after the first injection of triptorelin pamoate 11.25 mg|"Analyses performed on:~Intention to Treat (ITT): all patients having received ≥1 injection. Any subject with missing data is considered a non-responder.~Modified ITT (mITT): all ITT patients with ≥ Month 3 post-baseline assessment of primary efficacy criterion.~Per Protocol (PP): all mITT patients without major protocol deviations."||participants|||Number
128524|NCT00564733|Primary|Overall Response Rate (Patients That Achieve a CR or PR)|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At the end of 4 cycles of treatment, up to 24 weeks.|All patients that signed consent and received at least one cycle of chemotherapy.||participants|||Number
128525|NCT00564681|Secondary|Duration of Treatment Effect for Treatment Responders|Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms).|Up to 6 Months|Intent-to-Treat: All enrolled patients||Days||95% Confidence Interval|Median
128526|NCT00564681|Secondary|Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1|Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement).|Baseline, Week 4|Intent-to-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
128527|NCT00564681|Secondary|Patient’s Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Patient’s global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
128528|NCT00564681|Secondary|Physician’s Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1|Physician’s global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Intent-to-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
128529|NCT00564681|Primary|Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1|Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening.|Baseline, Week 4|Intent-To-Treat: All enrolled patients||Scores on a Scale||Standard Deviation|Mean
128530|NCT00564629|Secondary|WSTD6|This outcome measure is a statistical analysis of WSTD6, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 6 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-6 hours|||degrees Celsius||Standard Deviation|Mean
128531|NCT00564629|Secondary|WSTD5|This outcome measure is a statistical analysis of WSTD5, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 5 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-5 hours|||degrees Celsius||Standard Deviation|Mean
128532|NCT00564629|Secondary|WSTD4|This outcome measure is a statistical analysis of WSTD4, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 4 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-4 hours|||degrees Celsius||Standard Deviation|Mean
128533|NCT00564629|Secondary|WSTD3|This outcome measure is a statistical analysis of WSTD3, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 3 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-3 hours|||degrees Celsius||Standard Deviation|Mean
128534|NCT00564629|Secondary|The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes|This outcome measures what percentage of total subjects had a temperature < 38 ºC and < 38.5 ºC at any timepoint during the time from T0 to T360 minutes.|T0 to T360 minutes|Analysis performed on mITT population.||percentage of participants|||Number
128535|NCT00564629|Secondary|Subject's Global Evaluation of Study Medication at T360 Minutes|"This outcome measures how satisfied the subject was with the study treatment. The subject was asked to answer Overall, how would you rate study treatments? at T360 minutes using a 4-point categorical scale (0=poor, 1=fair, 2=good, 3=excellent)."|T360 minutes|Analysis performed on the mITT population.||participants|||Number
128799|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128537|NCT00564629|Secondary|Time to a Reduction in Temperature From T0 to T360 Minutes.|This outcome measures how much time it took to observe a decrease in subjects' core body temperature by 0.8 ºC, 1.0 ºC, and 1.5 ºC from the temperature at T0 and from the temperature at the peak after T0 through T360 (6 hours). The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|6 hours|Analysis was performed on the mITT population.||Hours||Standard Deviation|Mean
128538|NCT00564629|Primary|The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2)|This outcome measures when the antipyretic effect begins by statistical analysis of WSTD2, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 2 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.|0-2 hours|mITT population defined as all randomized subjects who received at least 1 full dose of oral study medication (subject not vomiting within 2 hours after oral study drug) or 1 full dose of IV study medication(subject having received all 100 mls solution). This analysis was performed with imputation for non-physiological temperature swing zone effect||Degrees Celsius||Standard Deviation|Mean
128539|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event|"The number of subjects who reported at least one treatment emergent SAE during the study.~A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded study medication that:~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event"|First dose to 30 days after last dose of study medication.|All analyses were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.||Subjects|||Number
128540|NCT00564486|Secondary|The Number of Subjects Reporting a Treatment Emergent Adverse Event|"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)."|First dose through 7 day follow up|All analyses of safety were conducted on the safety population, which included those subjects who received any portion of a dose of study medication.||Subjects|||Number
128541|NCT00564486|Secondary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with 0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period."|Baseline to 24 hrs|Included modified Intent To Treat group (mITT), defined as randomized subjects who received at least one complete infusion of study medication prior to receiving rescue medication.||Units on a scale||Standard Deviation|Mean
128542|NCT00564486|Primary|Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)|"Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with 100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period."|Baseline to 24 hrs|All efficacy analyses were conducted using the modified intent-to-treat (mITT) population, defined as those subjects who received at least one complete infusion of study medication prior to requesting rescue medication.Worst Observation Carried Forward (WOCF) imputation was applied after first rescue medication.||Units on a scale||Standard Deviation|Mean
128543|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters|Conjunctiva Concentration of Azithromycin and Moxifloxacin|Over 24 hours|||μg/g||Standard Deviation|Mean
128544|NCT00564447|Primary|Assessment of Pharmacokinetic Parameters||Up to 24 hours||||||
128545|NCT00564278|Secondary|Proportion of Fully Adherent Days|We used the Composite Adherence Score (CAS) described in our grant application to calculate medication adherence levels from all data sources (electronic caps [eCaps], pill count, self-report) and compare these across arms. Calculated via a statistically calibrated algorithm, the CAS relied first on eCaps data, secondarily on pill count, and the adherence questionnaire if eCaps data was missing due to an eCap malfunction. We calculated the number of the days the patient was fully adherent, number of days of partial adherence (e.g., opened the eCap fewer times than prescribed), or number of days of nonadherence when they did not take any prescribed pills. Patients who dropped out of the study and provided no further follow-up data were considered nonadherent for the remainder of the study period. We calculated the therapy-adherent period as a proportion of the total intended treatment period or proportion of days of full adherence, # of fully adherent days / # of days in treatment.|Measured at each visit, up to 36 weeks|All patients in both arms||Proportion of Fully Adherent days||Standard Deviation|Mean
128546|NCT00564278|Secondary|Mean Patient Satisfaction Over 36-week Follow-up Using Client Satisfaction Questionnaire (CSQ)|Patient satisfaction was assessed using the 8-item Client Satisfaction Questionnaire (CSQ) which assesses patients' satisfaction with the services received. CSQ total score ranges from 8-32 with higher scores indicating greater satisfaction. The CSQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the CSQ over 36 weeks using repeated measures.|CSQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.||units on a scale ranging from 8 to 32||Standard Deviation|Mean
128607|NCT00563290|Secondary|COX-2 Presence by IHC|Performed per standard protocols by the Pathology Department. Samples will be obtained pre-therapy. Determination of the COX-2 tumor status on this trial will develop the beginnings of a data base upon which future therapy may be designed.|At baseline|Funding was not available to do correlative studies|||||
128547|NCT00564278|Primary|Mean Perceived Quality of Life Over 36-week Follow-up Using Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|Quality of life was assessed using the 16-item Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ), a self-reported measure of quality of life in 8 domains that is sensitive to depressive symptom severity and treatment response. We analyzed the QLESQ total score as a percentage of the maximum possible score (ranging from 0-100) to facilitate comparisons across areas of functioning. It was calculated as such: % Max = (Raw score - minimum possible score) / (maximum possible score-minimum possible score) where raw score is the sum of the first 14 items. Higher numbers indicate better quality of life, greater enjoyment, and satisfaction. The QLESQ was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the QLESQ over 36 weeks using repeated measures.|QLESQ at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.||percentage of maximum possible score||Standard Deviation|Mean
128548|NCT00564278|Primary|Mean Disability Over 36-week Follow-up Using Sheehan Disability Scale (Impairment)|Psychosocial functioning was assessed using the Sheehan Disability Scale (SDS), a self-report instrument composed of three visual analog subscales assessing degree of disruption caused by symptoms in three domains: work, social/leisure activities, and family/home life. We analyzed the 3 subscale scores for the 3 domains separately which ranged from 0 to 10 with higher scores indicating worse functioning. The SDS was assessed at baseline and the follow-up visits specified below. We calculated the model-estimated mean of the SDS over 36 weeks using repeated measures.|SDS at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|Patients with available data at assessment time points.||Units on a scale ranging from 0-10||Standard Deviation|Mean
128549|NCT00564278|Primary|Mean of Depressive Symptoms Over 36-week Follow-up Using Hamilton Depression Scale -17-item Version (Symptoms)|"Depressive symptoms were assessed using the 17-item standard clinician-administered version of the Hamilton Depression Scale (HAMD-17). We analyzed the HAMD-17 score, calculated as the sum of the individual items and ranging from 0 to 35 with higher numbers indicating more symptoms. HAMD-17 was assessed at baseline and the follow-up visits specified below.~We calculated the model-estimated mean of the HAMD-17 over 36 weeks using repeated measures."|HAMD-17 assessed at follow-up weeks 2, 4, 8, 12, 20, 28, and 36.|All patients enrolled in both arms with available data at assessment time points.||units on a scale ranging from 0 to 35||Standard Deviation|Mean
128550|NCT00564278|Primary|Number of Days in ADT (Retention)|A continuous measure of the total number of days in treatment, based on visit attendance. At each kept visit, patients will be credited as having been in treatment for the number of days since their last scheduled visit. For example, patients attending sessions on weeks 0, 1, and 12 would have been in treatment for 35 days (7 [week 0 to week 1] + 28 [week 8 to week 12]).|Measured at Months 3 and 9|Patients who signed consent and attended at least one medication visit.||Days in treatment||Standard Deviation|Mean
128551|NCT00564265|Primary|Number of Patients Who Survived|The outcomes were measured through follow-up visits of the patients to the out-patient clinic of our institution at 15 days, 1 month, 3 months, 6 months, 1 year, and after that, every year after the surgical treatment.|5 years|This is a consecutive sample of all patients operated on for GISTs in 3 hospitals during a period of 5 years. The period of 5 years was determined by the time that we count with inmunochemistry to confirm GISTs at our institutions, and that time would be the last 5 years. The Last Observation Carried Dorward (LOCF) was made in August 2008.||Participants|||Number
128552|NCT00563797|Secondary|Mean Percentage of Heavy Drinking Days by Smoking|The two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo.|25 weeks|||percentage of Heavy Drinking Days||Standard Deviation|Mean
128553|NCT00563797|Secondary|Mean Percentage of Number of Drinking Days by Smoking Status|Two-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo.|25 weeks|||Percentage of Drinking Days||Standard Deviation|Mean
128554|NCT00563797|Primary|Depression - Measured Using the HAMD Total Score|"The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient’s level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients.~Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression)"|12 weeks|||units on a scale||Standard Deviation|Mean
128555|NCT00563797|Primary|Number of Drinking Days|Measured with time line follow back measures|25 weeks|||days||Standard Deviation|Mean
128556|NCT00563706|Secondary|Calgary Depression Scale for Schizophrenia (CDSS) Score|CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128557|NCT00563706|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale to assess global improvement in the participant’s clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).|Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128558|NCT00563706|Secondary|Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128608|NCT00563290|Secondary|Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)|Performed per standard protocols by the Pathology Department.|At baseline|Funding was not available to do correlative studies|||||
128559|NCT00563706|Secondary|Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score|Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128560|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score|Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128561|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score|General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128562|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Negative Subscale Score|PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128563|NCT00563706|Secondary|Positive and Negative Symptom Scale (PANSS) Positive Subscale Score|PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.|Baseline, Day 7, 14, 21, 28|Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.|||||
128564|NCT00563706|Primary|Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Day 28|mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
128565|NCT00563706|Primary|Positive and Negative Symptom Scale (PANSS) Total Score at Baseline|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.||units on a scale||Standard Deviation|Mean
128566|NCT00563576|Secondary|Percentage of Subjects Who Receive a 3rd Injection||6 months||||||
128567|NCT00563576|Secondary|Number of Subjects Who Receive a 2nd Injection of Depo-Provera||3 months|||participants|||Number
128568|NCT00563576|Secondary|Percentage of Users Who Were Satisfied With Femring|Acceptability was measured using questionnaires that assessed satisfaction of Femring and usage of the ring. This outcome was only measured among the intervention group of women who actually were randomized to use of Femring. Acceptability of the vaginal ring was high among those in the intervention group.|3 months|Acceptability was reported among the 26 participants in the Femring group who were available for followup, i.e., per protocol.||participants|||Number
128569|NCT00563576|Primary|Mean Number of Bleeding or Spotting Days|Bleeding and spotting were defined using World Health Organization criteria and measured through daily diaries given to participants and collected at the 3 and 6 month followup. In addition, a study staff member called participants weekly to collect the daily bleeding and spotting calendar for that week to optimize the accuracy of this information.|3 months|||days||Standard Deviation|Mean
128800|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|12 Months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128570|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128571|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128572|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128573|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128574|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128575|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128576|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128577|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128578|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128579|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128580|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128581|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128582|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128583|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128584|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128585|NCT00563381|Secondary|Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1|PEFR means peak expiratory flow rate and is measured in liter per minute|16 weeks|All patients who received study medication, were randomised, were documented to have taken at least one dose of double-blind treatment, gave informed consent to genotyping, took part in the pre-specified part of the genotyping analysis, and who have evaluable blood samples||liter per minute (L/min)||Standard Error|Mean
128586|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
128587|NCT00563381|Secondary|COPD Exacerbations Treated With Antibiotics Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
128588|NCT00563381|Secondary|COPD Exacerbations Treated With Systemic Steroids Per Patient-year|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
128589|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
128590|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Antibiotics|First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
128591|NCT00563381|Secondary|First Occurrence of COPD Exacerbations Treated With Systemic Steroids|First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
128592|NCT00563381|Secondary|First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First|First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
128593|NCT00563381|Secondary|Number of Participants With Premature Discontinuation of Trial Medication||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Participants|||Number
128594|NCT00563381|Secondary|Occurrence of Premature Discontinuation of Trial Medication|Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
128801|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|12 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128595|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Participants|||Number
128596|NCT00563381|Secondary|First Occurrence of COPD Exacerbation Leading to Hospitalization|First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
128597|NCT00563381|Secondary|COPD Exacerbations Per Patient-year||52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||exacerbations per patient-year||95% Confidence Interval|Mean
128598|NCT00563381|Secondary|Number of Participants With at Least One COPD Exacerbation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Participants|||Number
128599|NCT00563381|Secondary|COPD Exacerbations Per Patient-year Leading to Hospitalisation|An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||Hospitalizations per patient-year||95% Confidence Interval|Mean
128600|NCT00563381|Primary|First Occurrence of (Moderate or Severe) COPD Exacerbation|First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).|52 weeks|All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment||number of first occurrences|||Number
128601|NCT00563368|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 28 With LOCF||baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percentage of participants|||Number
128602|NCT00563368|Primary|Percent Weight Loss From Baseline to Week 28|Percent weight loss from baseline to Week 28 with last observation carried forward (LOCF)|baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
128603|NCT00563316|Primary|Number of Participants With Clinically Significant Adverse Events (AEs)|"Adverse events of special interest include infusion reactions, integument toxicities, diarrhea, stomatitis, hypomagnesemia, and pulmonary, vascular, and cardiac toxicities. Infusion reactions were defined as 1. Prespecified signs and symptoms indicating a possible infusion reaction (derived from Common Terminology Criteria for Adverse Events (CTCAE) definitions of allergic reaction/hypersensitivity and cytokine release syndrome/acute infusion reaction) with onset day coincident with any study drug infusion and which resolved the day of, or the day after, onset; 2. incidence of AE with terms consistent with the panitumumab US package insert (USPI) (any event within 24 hours of an infusion during the clinical study described as allergic reaction or anaphylactoid reaction, or any event occurring on the first day of dosing described as allergic reaction, anaphylactoid reaction, fever, chills, or dyspnea).~Data are summarized overall and by treatment phase."|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date, until the data cut-off date of 16 July 2009. The median time frame is 5.7 months.|All treated participants||participants|||Number
128604|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of the Last Quantifiable Concentration (AUClast) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUClast of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set||hr*ng/mL||Standard Deviation|Mean
128605|NCT00563316|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUCinf) for Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the AUCinf of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set||hr*ng/mL||Standard Deviation|Mean
128606|NCT00563316|Primary|Maximum Observed Plasma Concentration (Cmax) of Irinotecan|To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the Cmax of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured. Plasma samples were assayed by a validated high performance liquid chromatography (HPLC)-fluorescence method for the measurement of irinotecan. The lower limit of quantitation (LLOQ) was 2 ng/mL.|Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1).|The pharmacokinetic analysis set included all participants who received panitumumab 6 mg/kg and irinotecan 180 mg/m² without dose reductions or delays and who completed the blood sample collection for pharmacokinetic analysis during cycles 1 and 2.||ng/mL||Standard Deviation|Mean
128609|NCT00563290|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Time from start of treatment to time of progression, assessed up to 12 weeks|The second treatment arm of Dasatinib 70 mg orally twice a day was created as a result of an amendment to the protocol therefore the patient PFS data was combined for each arm.||weeks||Full Range|Median
128610|NCT00563290|Primary|Objective Response Rate (Complete Response and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment|||percentage of patients|||Number
128611|NCT00562861|Primary|MADRS Rating Scale Change|Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.|6 weeks|All patients randomized were analyzed in intent to treat manner.||units on a scale||Standard Deviation|Mean
128612|NCT00562627|Secondary|Time to Readiness for Discharge|Each postoperative day, discharge readiness was assessed by an orthopaedic surgeon, a pain nurse, a ward nurse, and a physiotherapist according to the following criteria: no evidence for surgical complications, VAS pain at rest ≤30 mm which is controlled by oral analgesics, ability to eat and drink, ability to walk with elbow crutches, and ability to climb ≥8 stairs.|up to 10 days postoperative|||days||Standard Deviation|Mean
128613|NCT00562627|Primary|Pain at Rest (VAS)|VAS (pain at rest) 0-100 mm. VAS 0 mm means no pain and VAS 100 mm means maximal pain.|48 hours postoperative|||Units on a scale||Standard Deviation|Mean
128614|NCT00562627|Secondary|Opioid Use|Morphine used by patient controlled analgesia. Amount of used morphine during the first 48 hours after surgery were documented in the CRF by the pain nurses.|48 hours postoperative|||mg||Standard Deviation|Mean
128615|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 90|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 90.||mL||Inter-Quartile Range|Median
128616|NCT00562588|Secondary|Change From Baseline in DWI (Diffuse-Weighted Imaging) at Day 8|MRI was performed to assess growth in stroke lesion volume by diffusion-weighted imaging (DWI). DWI was to give evidence of the development of the ischaemic lesion corresponding to the evolved stroke.|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in DWI at baseline and day 8.||mL||Inter-Quartile Range|Median
128617|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 90.|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 90|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 90.||mL||Inter-Quartile Range|Median
128618|NCT00562588|Secondary|Change From Baseline in FLAIR (Fluid-Attenuated Inversion Recovery) at Day 8|MRI was performed to assess growth in stroke lesion volume by fluid-attenuated inversion recovery (FLAIR).|Baseline and day 8|Full Analysis Set - included all randomised patients who had value in FLAIR at baseline and day 8.||mL||Inter-Quartile Range|Median
128619|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value - MCP-1|Changes of special biochemical laboratory value (MCP-1) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||µg/mL||95% Confidence Interval|Geometric Mean
128620|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- MMP-9|Changes of special biochemical laboratory value (MMP-9) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||ng/mL||95% Confidence Interval|Geometric Mean
128621|NCT00562588|Secondary|Change of Special Biochemical Laboratory Value- CRP|Changes of special biochemical laboratory values (CRP) from baseline to day 8 - centralised, blinded assessment by a specialised central clinical laboratory|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||mg/L||95% Confidence Interval|Geometric Mean
128622|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) at Day 8|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||units on a scale||Inter-Quartile Range|Median
128623|NCT00562588|Secondary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment) at Day 8|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|8 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||participants|||Number
128624|NCT00562588|Secondary|Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding)||90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||participants|||Number
128625|NCT00562588|Secondary|Change From Baseline in NIHSS (National Institutes of Health Stroke Scale)|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead)|Baseline and 90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||Units on a scale||Inter-Quartile Range|Median
128802|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128626|NCT00562588|Primary|Telephone Modified Rankin Scale (Centralised, Blinded Assessment)|The modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. Best value - 0 (No symptoms), worst value - 6 (Dead)|90 days|FAS which included all randomised patients who had follow up data available (mRS or NIHSS) or who were dead.||participants|||Number
128627|NCT00562484|Secondary|New Onsets of Chronic Illness (NOCI)|An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
128628|NCT00562484|Secondary|Serious Adverse Events (SAEs)|"An SAE was any untoward medical occurrence that at any dose:~Resulted in death;~Was life-threatening;~Required an unexpected in-participant hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant disability / incapacity;~Was a congenital anomaly / birth defect; and / or~Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out"|180 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
128629|NCT00562484|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|"UAE grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities."|21 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL's IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
128630|NCT00562484|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms|"Adverse event grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities.~Fever Grade 1: ≥ 37.7°C - < 38.0°C (≥ 99.9 - < 100.4°F) Grade 2: ≥ 38.0°C - < 39.0°C (≥ 100.4 - < 102.2°F) Grade 3: ≥ 39.0°C (> 102.2°F)"|5 days after study vaccination|Safety Population comprised all participants who received study vaccine (CSL’s IVV or placebo) and provided at least one safety assessment after the vaccination.||Participants|||Number
128631|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Fold increase||95% Confidence Interval|Number
128632|NCT00562484|Secondary|Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008|Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Fold increase||95% Confidence Interval|Number
128633|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
128634|NCT00562484|Secondary|Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008|Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.|21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
128635|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
128636|NCT00562484|Secondary|Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008||21 days after study vaccination|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants||95% Confidence Interval|Number
128803|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128637|NCT00562484|Secondary|Incidence of Influenza-like Illness (ILI)|"The criteria for the protocol defined ILI were as follows:~At least one respiratory symptom:~cough, sore throat or nasal congestion~And at least one systemic symptom:~fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant’s subjective feeling of fever), chills or body aches.~The CDC ILI case definition was the occurrence of fever (100°F [37.8°C] or higher) in conjunction with either cough or sore throat."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Percentage of participants|||Number
128638|NCT00562484|Secondary|CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains|"Incidence of laboratory confirmed influenza A/B infection due to strains matched to vaccine strains was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.~Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / Placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Ratio||95% Confidence Interval|Number
128639|NCT00562484|Primary|CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection|"Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons.~Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate."|2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009|Evaluable Population for the Clinical Endpoint Analysis consisted of all participants who: received study vaccine and clinical endpoint follow-up was longer than 14 days after vaccination; and had not taken any contraindicated medications during the On-study or Clinical Endpoint Periods as potentially impacting clinical endpoint assessments.||Ratio||95% Confidence Interval|Number
128640|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
128641|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for Overall Population|Systemic events reported using electronic diary. Fever scaled as Any (≥37.5 degrees Celsius [C]); Mild (≥37.5 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 to ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Any aggravated muscle pain, New joint pain, and Any aggravated joint pain.|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
128642|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
128643|NCT00562354|Secondary|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for Overall Population|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder).|Day 1 through 14|Safety population included all participants who received the study treatment. N=number of participants with analyzable data for reactogenicity events. Participants may be represented in more than 1 category.||percentage of participants|||Number
128644|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
128645|NCT00562354|Secondary|Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
128646|NCT00562354|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody concentration for the specified serotype. GMCs calculated using all participants with available data for the specified blood draw.||mcg/mL||95% Confidence Interval|Geometric Mean
128647|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
128648|NCT00562354|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific IgG antibody concentrations for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), as measured by enzyme-linked immunosorbent assay (ELISA). IgG concentrations will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentration (GMC) in micrograms per mL (mcg/mL). The 2-sided, 95% CIs on the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMCs calculated using all participants with available data for both the specified blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
128649|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128650|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128651|NCT00562354|Secondary|Percentage of Participants Achieving ≥4-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 4-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128652|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination by Age Group|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128653|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128804|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|4 months post operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128654|NCT00562354|Secondary|Percentage of Participants Achieving ≥2-fold Rise in Serotype Specific OPA Titers for the 13 Serotypes 1 Month After Vaccination for Overall Population|For each serotype the proportion (percentage of participants) achieving at least a 2-fold rise on the serotype-specific antibody titer from prevaccination to 1 month postvaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128655|NCT00562354|Secondary|Comparison of Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination by Age Group|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128656|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128657|NCT00562354|Secondary|Percentage of Participants Achieving Serotype Specific OPA Titers ≥ Lower Limit of Quantitation (LLOQ) for the 13 Serotypes 1 Month After Vaccination for Overall Population|For OPA assays serotype-specific lower limit of quantitation (LLOQ) was derived the 13 serotypes: serotype 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. For each serotype the proportion (percentage of participants) achieving an OPA titer of at least 1:LLOQ was computed along with exact, 2-sided 95% confidence interval for the proportion.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate postvaccination OPA antibody titers to the given serotype.||percentage of participants||95% Confidence Interval|Number
128658|NCT00562354|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination by Age Group|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with determinate antibody titers for the specified serotype. GMTs calculated using all participants with available data for the specified blood draw.||titer||95% Confidence Interval|Geometric Mean
128659|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
128660|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination to 1 Month After Vaccination for Overall Population|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination (Day 1), 1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws. GMFRs calculated using all participants with available data from both the prevaccination and postvaccination blood draws.||fold rise||95% Confidence Interval|Geometric Mean
128661|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Age Groups 50 to 64 Years and ≥65 Years|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% CIs on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.||titer||95% Confidence Interval|Geometric Mean
128712|NCT00561977|Primary|Dietary Quality, Possible Score From Zero to 80 (Best Quality Diet).|The AHEI consists of 8 components (eg, vegetables,trans fat). Each contributed 0–10 points to the total score; a score of 10 indicates that the recommendations were fully met, whereas a score of 0 represents the least healthy dietary behavior. Intermediate intakes were scored proportionately between 0 and 10. All component scores were summed to obtain a total AHEI score ranging from zero(worst) to 80(best).|3 months|||score||Standard Deviation|Mean
128662|NCT00562354|Primary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After Vaccination for Overall Population|Serotype-specific antibody-mediated opsonophagocytic activity (functional antibodies) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) as measured by a quantitative opsonophagocytic activity assay (OPA). OPA titers will be logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). The 2-sided, 95% confidence intervals (CIs) on the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after vaccination|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with valid and determinate assay results for the specified serotype at both blood draws.||titer||95% Confidence Interval|Geometric Mean
128663|NCT00562328|Secondary|Time to Subsequent Therapy|Time to subsequent treatment (TTS) was defined as the time from end of active (protocol) treatment to the start of subsequent treatment. The median TTS with 95% CI was estimated using the Kaplan Meier method.|time from end of protocol treatment to subsequent treatment (up to 5 years)||||||
128664|NCT00562328|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 5 years)||||||
128665|NCT00562328|Secondary|Duration of Response|Duration of response (DOR) is defined as the time from documentation of response (CR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method.|time from start of response to progression (up to 5 years)||||||
128666|NCT00562328|Secondary|Time to Response|Time to response (TTR) is defined as the time from registration to first documentation of response (CR or PR). In participants who do not achieve a response, time will be censored at the participants last evaluation (for disease) date. The median TTR with 95% CI was estimated using the Kaplan Meier method.|time from registration to first documentation of response (up to 5 years)||||||
128667|NCT00562328|Secondary|Time to Disease Progression|Time to disease progression (TTP) was defined as the time from registration to the earliest date documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Time from registration to progression (up to 5 years)||||||
128668|NCT00562328|Primary|Proportion of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months|"Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months:~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months|||participants|||Number
128669|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]~Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed~Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.||percentage of true tests||95% Confidence Interval|Number
128670|NCT00562315|Secondary|Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)~Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed~Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.||percentage of true tests||95% Confidence Interval|Number
128671|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives)~Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives)~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed~Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed"|Up to 5 years|Participants with a definitive consensus on the presence or absence of prostatic/bed disease.||percentage of true tests||95% Confidence Interval|Number
128713|NCT00561977|Primary|Dietary Quality|Dietary quality was measured by the Alternative Healthy Eating Index (AHEI), a scale of healthy eating that goes from zero to 80 (best score).|6 mos|||score||Standard Deviation|Mean
128672|NCT00562315|Primary|Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma|"Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)]~Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)]~Accuracy = (True positives + true negatives)/all tests~Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed~Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed"|Up to 5 years|Participants with a definitive consensus for the presence or absence of extraprostatic disease.||percentage of true tests||95% Confidence Interval|Number
128673|NCT00562315|Primary|Number of Participants With False Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
128674|NCT00562315|Primary|Number of Participants With False Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
128675|NCT00562315|Primary|Number of Participants With True Negative Scans Outside the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
128676|NCT00562315|Primary|Number of Participants With True Positive Scans Outside the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.|Up to 5 years|There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.||participants|||Number
128677|NCT00562315|Primary|Number of Participants With False Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
128678|NCT00562315|Primary|Number of Participants With True Negative Scans Within the Prostate Bed|Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
128679|NCT00562315|Primary|Number of Participants With False Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
128680|NCT00562315|Primary|Number of Participants With True Positive Scans Within the Prostate Bed|Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.|Up to 5 years|91 participants had sufficient data to determine disease presence or absence in the prostate bed.||participants|||Number
128681|NCT00562302|Secondary|Incidence of Adverse Events|Any treatment emergent adverse events (not considered device related by the investigators).|30 days|Intent to Treat Population||participants|||Number
128682|NCT00562302|Secondary|Participants Discharged Beyond Hospital's Standard of Care|Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital’s standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.|30-day|Intent to Treat Population||participants|||Number
128683|NCT00562302|Secondary|Number of Participants With Additional Chest X-rays Needed||30 day|Intent to Treat Population||participants|||Number
128684|NCT00562302|Secondary|Incidence of Adverse Events Related to the Procedure and Device Effects|Anticipated, device-related adverse events that were defined in the original protocol.|30 Day|Intent to Treat Patients||participants|||Number
128685|NCT00562302|Secondary|Incidence of Hospital Admissions for Pneumothorax||30 day|Intent to treat Population||participants|||Number
128686|NCT00562302|Secondary|Time to Ambulation||30 days|Intent to Treat Population||Hours||Standard Deviation|Mean
128687|NCT00562302|Secondary|Incidence of Chest Tube Placement|A chest tube is the definitive initial treatment of a pneumothorax.|30 days|Intent to treat Population||participants|||Number
128688|NCT00562302|Primary|Incidence Rate of Treatment Success|Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).|30 days|Per Protocol Population||participants|||Number
128689|NCT00562159|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS|The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Deviation|Mean
128690|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
128691|NCT00562159|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18.|Start of the GPS to End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
128692|NCT00562159|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication.|Start of the GPS to End of the GPS|The full analysis set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
128693|NCT00562120|Other Pre-specified|Serum PF-03654746 Concentration|Only participants receiving PF-03654746 were analyzed for this outcome measure. Mean serum concentration of PF-03654746 was calculated of each intervention period.|1 hr 30 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
128694|NCT00562120|Secondary|Nasal Symptom Scores: Sneezing|The absolute number of sneezes was recorded by the participants under supervision of study personnel. Nasal symptom score for sneezing was assessed as the total number of sneezes of each intervention period at specified time-points for the post-diluent and post-challenge and post where ‘post-diluent, pre-allergen challenge’ included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and ‘post-allergen challenge’ included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||sneezes||Standard Deviation|Mean
128695|NCT00562120|Secondary|Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea|Nasal symptoms included; nasal congestion: participants rated sensation of nasal blockage on 0 (no blockage) to 5 (total blockage) scale, nasal itching: participants rated sensation of nasal itch on 0 (no itch) to 5 (very itchy) scale, rhinorrhea: participants rated sensation of runny nose on 0 (no running) to 5 (very runny) scale. Symptom scores were assessed as mean of each intervention period at specified time-points for ‘post-diluent, pre-allergen challenge’ measure and ‘post-challenge’ measure. Post-diluent, pre-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose at each intervention period and post-allergen challenge (for congestion, itching, rhinorrhea) included 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose at each intervention period and (for congestion only) 3 hrs 40 min post PF-03654746/placebo dose (Post-oxymetazoline) at each intervention period.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||units on a scale||Standard Deviation|Mean
128696|NCT00562120|Secondary|Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Nasal volume at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall for nasal volume was calculated as baseline measure minus smallest ‘post-allergen challenge’ nasal volume measurement among the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||cubic centimeter (cm^3)||Standard Deviation|Mean
128714|NCT00561951|Secondary|The Number of Patients With “Severe Problems, Score 5” or “Many Severe Problems, Score 6” in Patient Perception of Bladder Condition (PPBC) at Week 12.|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:~No problems at all~Some very minor problems~Some minor problems~Some moderate problems~Severe problems~Many severe problems"|Baseline to Week 12|Full analysis set. No imputation was used for missing data||participants|||Number
128715|NCT00561951|Secondary|Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.|"Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:~No problems at all~Some very minor problems~Some minor problems~Some moderate problems~Severe problems~Many severe problems~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. No imputation was used for missing data.||score on scale||Standard Deviation|Mean
128697|NCT00562120|Secondary|Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. The mean of the left and right nostril measurements was taken as the measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of the 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures were recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period. The maximum fall in Amin was calculated as baseline measure minus smallest ‘post-allergen challenge’ Amin measurement of the 3 measures.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||square centimeter (cm^2)||Standard Deviation|Mean
128698|NCT00562120|Primary|Nasal Volume Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Nasal volume proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||ratio||Standard Deviation|Mean
128699|NCT00562120|Primary|Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry|Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, ‘post-diluent, pre-allergen challenge’ measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin ‘post-allergen challenge’ measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single ‘post-allergen challenge’ value. Amin proportion was defined as ratio of ‘post-allergen challenge’ value and ‘Baseline/pre-allergen challenge value’. Diluent used was saline and allergen was short ragweed extract.|2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period|Full analysis set included all participants randomized at baseline and who received at least 1 dose of double-blind treatment.||ratio||Standard Deviation|Mean
128700|NCT00562094|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
128701|NCT00562094|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|last visit (after a median of 18 days)|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||percentage of participants|||Number
128702|NCT00562094|Secondary|Assessment of the Severity of Sensation of Fullness/Abdominal Distension|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
128703|NCT00562094|Secondary|Assessment of the Severity of Epigastric Complaints/Epigastric Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
128704|NCT00562094|Secondary|Assessment of the Severity of Eructation/Acid Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
128705|NCT00562094|Secondary|Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||units on a scale||Standard Deviation|Mean
128706|NCT00562094|Primary|Assessment of Change of Quality of Sleep During Therapy With Pantoprazole|"Physician's assessment on a scale with~considerably improved~improved~unchanged"|last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed||percentage of participants|||Number
128707|NCT00562094|Primary|Assessment of the Severity of Sleep Disturbances|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|first and last visit (after a median of 18 days)|All patients included and treated, intention to treat, missing values not imputed||percentage of participants|||Number
128708|NCT00561977|Secondary|Change in Calories From Baseline to 6 Months|kilocalories|6 months|||calories||Standard Deviation|Mean
128709|NCT00561977|Secondary|Change in Calories From Baseline to 3 Months|kilocalories|3 months|||calories||Standard Deviation|Mean
128710|NCT00561977|Secondary|Change in Weight From Baseline to 6 Months||6 months|||pounds||Standard Deviation|Mean
128711|NCT00561977|Secondary|Change in Weight From Baseline to 3 Months||3 months|||pounds||Standard Deviation|Mean
128716|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.|"The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).~The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Half scale rule (domain scores were calculated if a respondent had answered at least half of the items in a multi-item scale. Missing items were then replaced by the mean of non-missing items in that scale, for that participant.)||score on scale||Standard Deviation|Mean
128717|NCT00561951|Secondary|Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).|"King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week12|Full analysis set. No imputation was used for missing data.||score on scale||Standard Deviation|Mean
128718|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||mL||Standard Deviation|Mean
128719|NCT00561951|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12.|"Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||mL||Standard Deviation|Mean
128720|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|"Participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline within the full analysis set.~No imputation was used for missing data."||Night-Time Micturitions||Standard Deviation|Mean
128721|NCT00561951|Secondary|Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.|"Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|"Among the full analysis set, participants who had mean number of night-time micturitions per 24 hours of greater than 0 at baseline .~Last observation carried forward."||Night-Time Micturitions||95% Confidence Interval|Least Squares Mean
128722|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Incontinence is the complaint of any involuntary leakage of urine.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||Incontinence Episodes||Standard Deviation|Mean
128723|NCT00561951|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.|"Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Incontinence is the complaint of any involuntary leakage of urine.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward||Incontinence Episodes||95% Confidence Interval|Least Squares Mean
128724|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||Urgency Episodes||Standard Deviation|Mean
128725|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.|"Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||Urgency Episodes||95% Confidence Interval|Least Squares Mean
128726|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||Micturitions||Standard Deviation|Mean
128727|NCT00561951|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|"Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||Micturitions||95% Confidence Interval|Least Squares Mean
128728|NCT00561951|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.|"Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at each visit minus mean at Baseline."|Baseline to Weeks 2, 4, 8, and 12|Full analysis set. No imputation was used for missing data.||UUI Episodes||Standard Deviation|Mean
128789|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128729|NCT00561951|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|"Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.~Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.~Change: mean at Week 12 minus mean at Baseline."|Baseline to Week 12|Full analysis set. Last observation carried forward.||UUI Episodes||95% Confidence Interval|Least Squares Mean
128730|NCT00561925|Secondary|Occurrence of Hepatic Events|Frequency of patients with hepatitis symptoms|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
128731|NCT00561925|Secondary|Relative Bioavailability Trough C_pre,ss,1|Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.|week 132|Only patients with trough drawn PK time window (12+/-2.5 hr for IR; 24+/-5hr for XR) at week 132 are included.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
128732|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
128733|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
128734|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
128735|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities||week 0 to 72|Treated set (TS) includes all patients who were dispensed study medication and were documented to have taken at least one doe of investigational treatment, including the lead in nevirapine dose||cumulative probability|||Number
128736|NCT00561925|Secondary|Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||cumulative probability|||Number
128737|NCT00561925|Secondary|Occurrence of Elevations in Laboratory Measurement by DAIDS Grade||until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
128738|NCT00561925|Secondary|Occurrence of Rashes|Frequency of patients with drug related rash events by functional grouping|until last patient completed 144 weeks (up to 193 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
128739|NCT00561925|Secondary|Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases||cells/cubic millimeter||Standard Deviation|Mean
128740|NCT00561925|Secondary|Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication; descriptive analysis uses the imputation method: last observation carried forward; statistical analysis uses observed cases||log10 copies/mL||Standard Deviation|Mean
128741|NCT00561925|Secondary|Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||proportion of participants|||Number
128742|NCT00561925|Secondary|Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
128743|NCT00561925|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||proportion of participants|||Number
128744|NCT00561925|Primary|Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of blinded medication||participants|||Number
128745|NCT00561912|Primary|Progression-free Survival (PFS) Times|Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.|From treatment start or until disease progression or death for any reason, at least 16 weeks|With one of the two participants ruled ineligible and inevaluable, there was insufficient data for statistical evaluation.||Weeks|||Number
128746|NCT00561834|Primary|Change in Visual Acuity|The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.|Baseline and 6 months|||lines change in Snellen chart|||Number
128747|NCT00561821|Secondary|Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period|An AE is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.||Number of participants|||Number
128748|NCT00561821|Secondary|Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period|An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.|Up to Day 16|All participants who received at least one dose of study medication.||Number of participants|||Number
128749|NCT00561821|Secondary|Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary|Satisfaction of Sleep Duration (SSD) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Units on a Scale||Standard Deviation|Mean
128750|NCT00561821|Secondary|Average Subjective Quality of Sleep Based on Sleep Diary|Quality of Sleep (QS) is a subjective number on a Visual Analog Scale ranging from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Daily recordings by the participant in an electronic diary (observed data only) were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Units on a Scale||Standard Deviation|Mean
128751|NCT00561821|Secondary|Average Subjective Wake Time After Sleep Onset Based on Sleep Diary|Wake Time after Sleep Onset (WASO) is after falling asleep initially, the subjective time that the participant was awake during the night. Daily recordings by the participant in an electronic diary (observed data only), were averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128752|NCT00561821|Secondary|Average Subjective Number of Awakenings Based on Sleep Diary|Number of awakenings between sleep onset and final awakening (NAW) is a subjective number (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Number of Awakenings||Standard Deviation|Mean
128753|NCT00561821|Secondary|Average Subjective Sleep Latency Based on Sleep Diary|Sleep latency (SL) is the time taken to fall asleep (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128754|NCT00561821|Secondary|Average Subjective Total Sleep Time Based on Sleep Diary|Total Sleep Time (TST) is a subjective time (observed data only) recorded daily by the participant in an electronic diary, that was averaged over the entire 16-day, double-blind treatment period.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128755|NCT00561821|Secondary|Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography|Number of stage shifts to stage 1 of sleep or to awaken was measured by PSG. A stage shift is the transition measured by PSG between various sleep stages. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of the number of stage shifts (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Number of stage shifts||Standard Deviation|Mean
128756|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the fourth quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128790|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128757|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the third quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128758|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the second quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128759|NCT00561821|Secondary|Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour PSG recording. WASO was recorded in the first quarter of the night, for at most 2 hours, by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128760|NCT00561821|Secondary|Average Number of Awakenings Measured by Polysomnography|Number of awakenings (NAW) was measured by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of NAW (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Number of awakenings||Standard Deviation|Mean
128761|NCT00561821|Secondary|Average Total Sleep Time Measured by Polysomnography|Total sleep time (TST) is the sleep time recorded by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of TST (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128762|NCT00561821|Secondary|Average Latency to Persistent Sleep Measured by Polysomnography|Latency to Persistent Sleep (LPS) is the time from lights out to the first 20 consecutive epochs scored as sleep by PSG. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of LPS (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.|Up to Day 16|The ITT population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128763|NCT00561821|Primary|Average Wake Time After Sleep Onset Measured by Polysomnography|"Wake time after sleep onset (WASO) is the total time awake between sleep onset and lights on; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged."|Up to Day 16|The intent to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind study medication and had at least one post-randomization efficacy assessment. Data from 11 participants located at one treatment site were not analyzed due to their lack of credibility.||Minutes||Standard Deviation|Mean
128764|NCT00561795|Primary|Number of Participants Experiencing Serious Adverse Events and Non-serious Adverse Events|"Safety and tolerability were measured by the number of participants with serious adverse events and non-serious adverse events. See the Adverse Event section of the results record for additional details and data."|Baseline to End of Study (up to a year)|||participants|||Number
128765|NCT00561795|Secondary|18-week Progression Free Survival|Defined as the number participants who have not had radiological disease progression per RECIST, confirmed CA-125 progression, or death due to any cause by the end of 18 weeks.|Baseline to Week 18|||participants|||Number
128766|NCT00561795|Secondary|Cancer Antigen (CA-125) Response|Defined as the number of participants who achieved a confirmed CA-125 response, which is defined as at least a 50% reduction in CA-125 levels from a pre-treatment sample.|Baseline until response (up to 2 years)|||participants|||Number
128791|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128792|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|36 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128767|NCT00561795|Secondary|Overall Response|Although the study protocol specified several efficacy analyses, due to poor tolerability of the combination regimen and the consequent early withdrawal of most participants, which led to a small sample size, efficacy analyses were not performed. Overall response is defined as the number of participants with CR or PR per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|Baseline until either response or progression (up to 2 years)|||participants|||Number
128768|NCT00561730|Secondary|Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Percentage of participants|||Number
128769|NCT00561730|Secondary|Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat||Percentage of participants|||Number
128770|NCT00561730|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
128771|NCT00561730|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
128772|NCT00561730|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat||Units on a scale||Standard Deviation|Mean
128773|NCT00561730|Primary|Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1755~Day 1 = 1740~Day 2 = 1740~Day 3 = 1733~Day 4 = 1732~Day 5 = 1725~Day 6 = 1727"||Units on a scale||Standard Deviation|Mean
128774|NCT00561730|Primary|Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1755~Day 1 = 1744~Day 2 = 1742~Day 3 = 1728~Day 4 = 1727~Day 5 = 1724~Day 6 = 1726"||Units on a scale||Standard Deviation|Mean
128775|NCT00561730|Primary|Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1754~Day 1 = 1742~Day 2 = 1739~Day 3 = 1733~Day 4 = 1730~Day 5 = 1726~Day 6 = 1729"||Units on a scale||Standard Deviation|Mean
128776|NCT00561730|Primary|Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1760~Day 1 = 1750~Day 2 = 1746~Day 3 = 1735~Day 4 = 1735~Day 5 = 1730~Day 6 = 1734"||Units on a scale||Standard Deviation|Mean
128777|NCT00561730|Primary|Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=None to 10=Extremely strong|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1767~Day 1 = 1758~Day 2 = 1757~Day 3 = 1744~Day 4 = 1743~Day 5 = 1739~Day 6 = 1739"||Units on a scale||Standard Deviation|Mean
128778|NCT00561730|Primary|Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)|Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 1769~Day 1 = 1760~Day 2 = 1761~Day 3 = 1751~Day 4 = 1749~Day 5 = 1742~Day 6 = 1747"||Units on a scale||Standard Deviation|Mean
128779|NCT00561652|Other Pre-specified|Participant Adherence With Week 26 Follow-up Questionnaire|Number of participants who completed week 26 follow-up questionnaire|26 weeks|||participants|||Number
128780|NCT00561652|Other Pre-specified|Participant Adherence With Week 12 Follow-up Questionnaire|Number of participants who completed their week 12 follow-up questionnaire|12 weeks|||participants|||Number
128781|NCT00561652|Other Pre-specified|Participant Adherence With Week 6 Follow-up Questionnaire|Number of participants who completed their week 6 follow-up questionnaire|6 weeks|||participants|||Number
128782|NCT00561652|Other Pre-specified|Participant Adherence With Prescribed Home Exercise|Number of participants who completed at least 20 hours of home exercise|12 weeks|||participants|||Number
128783|NCT00561652|Other Pre-specified|"Participant Adherence With Time and Attention Visits"|"Number of participants who completed at least 8 of 10 time and attention visits. Note that only arm 1 (nonchiropractic arm) receives time and attention visits."|12 weeks|"Only arm 1 received time and attention visits as their purpose was to balance the chiropractor provider contact time received by arm 2 participants."||participants|||Number
128784|NCT00561652|Primary|Participant Adherence With Education + Exercise Visits|Number of participants completing at least 3 of 4 education + exercise visits|12 weeks|||participants|||Number
128785|NCT00561652|Other Pre-specified|Participant Adherence With Chiropractic Visits|Number of participants who completed at least 12 chiropractic visits.|12 weeks|||participants|||Number
128786|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128787|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte Cobalt|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128788|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|48 months|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128805|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|4 months post-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128806|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Chromium|Erythrocyte Chromium|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128807|NCT00561600|Secondary|Analysis of Metal Ion Release - Erythrocyte Cobalt|Erythrocyte cobalt|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128808|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Chromium|Serum Chromium|pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128809|NCT00561600|Secondary|Analysis of Metal Ion Release - Serum Cobalt|Serum Cobalt|Pre-operative|Metal ion sub-study was limited to two sites. All participants with available data are presented below.||ug/L||Full Range|Median
128810|NCT00561600|Secondary|Harris Hip Function Score at 24 Months|Mean Harris Hip Function sub score at 24 months|24 months|||units on a scale 0-47. 47 is best||Standard Deviation|Mean
128811|NCT00561600|Secondary|Harris Hip Pain Sub Score at 24 Months|Mean Harris Hip Pain sub score|24 months|||units on scale of 0-44. 44 is best||Standard Deviation|Mean
128812|NCT00561600|Secondary|T-Test of Harris Hip Total Score Means at 24 Months|T-Test of Harris Hip total score means at 24 months|24 months|||Units on a scale of 0-100,100 is best.||Standard Deviation|Mean
128813|NCT00561600|Primary|Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes|"Composite success:~Revision free (life of study)~No evidence of radiographic failure (life of study)~Harris Hip score => 80 at 24 months"|24-month interval.|Out of the 265 enrolled subjects, 51 subjects were removed from the analysis for the following reasons: 2 deaths (1 inv, 1 control); 4 protocol violations (0 inv, 4 control); 6 consent withdrawn (2 inv, 4 control); 39 lost to follow-up (17 inv, 22 control).||participants|||Number
128814|NCT00561574|Secondary|Change From Baseline in Number of Awakenings (NAW)|"NAW was defined as the time recorded by participants in response to Weekly Sleep Diary question 2a During the past 7 nights, how many times did you wake up, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline NAW assessment.||Number of Awakenings||Standard Deviation|Mean
128815|NCT00561574|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how long did it take you to fall asleep, on average? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline SL assessment.||Minutes||Standard Deviation|Mean
128816|NCT00561574|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time were you awake, on average, after falling asleep initially? Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach."|Baseline and Week 52|The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline WASO assessment.||Minutes||Standard Deviation|Mean
128817|NCT00561574|Secondary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 During the past 7 nights, how much time did you actually spend sleeping, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a last observation carried forward (LOCF) approach."|Baseline and Week 52|The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had at least one postbaseline TST assessment.||Minutes||Standard Deviation|Mean
128818|NCT00561574|Primary|Change From Baseline in Total Nap Time|"Total nap time was assessed by participants in response to Weekly Sleep Diary question 9a How much time per day did you nap, on average?. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Minutes||Standard Deviation|Mean
128819|NCT00561574|Primary|Change From Baseline in Ability to Work/Function|"Ability to work/function was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 8 How were you able to work or function over the past 7 days?. Scores could range from 0=Not at all to 100=Very well. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Score on a Scale||Standard Deviation|Mean
128820|NCT00561574|Primary|Change From Baseline in Feeling Full of Energy|"Feeling full of energy was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 7 How full of energy have you felt over the past 7 days?. Scores could range from 0=Terribly tired to 100=Full of energy. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Score on a Scale||Standard Deviation|Mean
128821|NCT00561574|Primary|Change From Baseline in Alertness at Awakening|"Alertness at awakening was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 6 How did you feel upon awakening over the past 7 days?. Scores could range from 0=Tired to 100=Alert. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an observed cases (OC) approach."|Baseline and Week 52|The AST population consisted of all participants who received at least one dose of study drug.||Score on a Scale||Standard Deviation|Mean
129305|NCT00558259|Secondary|Centrally Confirmed Unexplained Deaths During the Intended Treatment Period|Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.|6 months|FAS and analysed as randomised.||participants|||Number
128822|NCT00561574|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 52 weeks|The AST population consisted of all participants who received at least one dose of study drug.||Participants|||Number
128823|NCT00561574|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 53 weeks|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of study drug.||Participants|||Number
128824|NCT00561470|Secondary|Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay|Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.|Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo|Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.||participants|||Number
128825|NCT00561470|Secondary|Number of Participants With Adverse Events (AE)|"All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization.~The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported."|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).||participants|||Number
128826|NCT00561470|Secondary|Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0.~CR reflected the disappearance of all tumor lesions (with no new tumors)~PR reflected a pre-defined reduction in tumor burden~Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 – 6 weeks."|From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)|The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation.||percentage of participants||95% Confidence Interval|Number
128827|NCT00561470|Secondary|Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)|"PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC.~PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.~The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred."|From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)|Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.||months|Participants|Inter-Quartile Range|Median
128828|NCT00561470|Primary|Overall Survival (OS)|"Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011).~OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model."|From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized.||months|Participants|Inter-Quartile Range|Median
128829|NCT00561457|Primary|Rate of Major Adverse Clinical Events (MACE)|Major Adverse Clinical Events defined as peri-procedural death (death during the procedure or prior to hospital discharge), target lesion revascularization (TLR), or stented segment restenosis (> 50%) at nine months postprocedure.|9-months|The analysis was an intention to treat (ITT)population which included the data for all completed patients (those who had a MACE event within 9-months and those who reached 9 months without experiencing an event). Natural censoring was used in the analysis according to the statistical analysis plan.||MACE events per 9 months||95% Confidence Interval|Mean
128830|NCT00561431|Secondary|Recovery of Renal Function, Defined as Not Requiring Dialysis After Discontinuation of CRRT|The number of participants who recover renal function at 30 days after enrollment in each arm.|Up to 30 days|intention to treat||Participants|||Number
128831|NCT00561431|Primary|Number of Participants Alive at 30 Days After Enrollment Compared Between High Dose Versus Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|The primary objective is to determine whether Continuous Venovenous Hemodiafiltration (CVVHDF) using an effluent rate of 35 ml/hr/kg (high dose) leads to an increased participant survival time as compared to CVVHDF using the standard effluent rate of 25 ml/hr/kg as measured by days on continuous renal replacement therapy (CRRT) at enrollment up to 30 days.|Up to 30 days|Intention to treat||participants|||Number
128832|NCT00561418|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 3 years|Unable to calculate time to progression for patients due to not enough follow up time|||||
128833|NCT00561418|Secondary|Duration of Response|Median follow up of living patients|Up to 5 years|||months||Full Range|Median
130142|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients||Participants|||Number
128834|NCT00561418|Secondary|Clinical Benefit|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|Response following AHSCT||patients|||Number
128835|NCT00561418|Primary|Safety and Tolerability of Vorinostat (SAHA) After Autologous Stem Cell Transplantation|NCI CTCAE version 3.0 was used to assess Adverse Events (AE) Grade 1=Mild AE Grade 2=Moderate AE Grade 3=Severe AE Grade 4=Life-threatening or disabling AE|Up to 3 years|||patients|||Number
128836|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24|The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. A negative change score indicates reduced burden.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Units on a scale||Standard Deviation|Mean
128837|NCT00561392|Primary|Percentage of Participants Who Were Compliant to the 10 cm^2 Patch|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Percentage of participants||Standard Deviation|Mean
128838|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Percentage of participants||95% Confidence Interval|Number
128839|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient’s condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline.|Baseline t0 Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Participants|||Number
128840|NCT00561392|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician|The ADCS-CGIC is an assessment tool to make a judgment of change in a patient’s condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Participants|||Number
128841|NCT00561392|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24|The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time.||Units on a scale||Standard Deviation|Mean
128842|NCT00561392|Secondary|Mean Change From Baseline in the Trail-making Test Part A Score at Week 24|The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Seconds||Standard Deviation|Mean
128843|NCT00561392|Secondary|Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Units on a scale||Standard Deviation|Mean
128885|NCT00561015|Primary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng*hr/ml||Standard Deviation|Mean
128844|NCT00561392|Primary|Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study|"Dosages of study medication prescribed to and taken by the patient was assessed in a Drug Administration Record with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver."|Baseline to Week 24|The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time.||Percentage of participants||95% Confidence Interval|Number
128845|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-experienced HCV-infected participants considered non-responders (participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV ribonucleic acid (RNA) levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up at selected time points following treatment with TMC435 coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right was 8, 7, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng.h/mL||Standard Deviation|Mean
128846|NCT00561353|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 in treatment-naïve HCV-infected participants administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng.h/mL||Standard Deviation|Mean
128847|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of Css,av for TMC435 in treatment-experienced HCV-infected participants (non-responders and relapsers, see defined above) at selected time points following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/ml||Standard Deviation|Mean
128848|NCT00561353|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation)of Css,av for TMC435 in treatment-naïve HCV-infected participants at selected time points administered TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Day 7 (predose); Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel A, Cohorts 1 and 2) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose) (Panel B, Cohorts 1 and 2)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/ml||Standard Deviation|Mean
128849|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows mean (standard deviation) of C0h for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 2 and Day 28 differed as follows: At Day 2, the number of participants in the 4 treatment groups (from left to right) were 8, 7, 10, and 5; the number of participants analyzed at Day 28 in the 4 treatment groups (from left to right) were 9, 8, 10, and 4.|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/mL||Standard Deviation|Mean
128886|NCT00561015|Secondary|Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15|The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
129451|NCT00557284|Secondary|Mean Change in Serum IgE Levels|Mean change in serum levels of IgE from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm.|Baseline and 9 weeks|||kU/L||Standard Deviation|Mean
128850|NCT00561353|Secondary|Predose Plasma Concentration (C0h) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows mean (standard deviation) of C0h of TMC435 at selected time points following treatment with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) or with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B) in treatment-naïve participants (see treatment-naïve defined above).The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 9, 8, 9, 9, and 10."|Day 2 (predose) and Day 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/ml||Standard Deviation|Mean
128851|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the mean (standard deviation) Cmax for treatment-experienced participants (non-responders and relapsers, see defined above) following treatment with TMC435 coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. The number of participants analyzed at Day 28 in the 4 treatment groups listed below from left to right were 8, 8, 10, and 3.|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/mL||Standard Deviation|Mean
128852|NCT00561353|Secondary|Maximum Plasma Concentration (Cmax) of TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B)|"The table below shows the mean (standard deviation) Cmax for treatment-naïve participants at selected time points who were treated with TMC435 for 7 days followed by TMC435 coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) and with TMC435 coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B). See treatment-naïve defined above. The number of participants analyzed at Day 28 in the 6 treatment groups listed below from left to right were 9, 8, 7, 9, 9, and 10."|Days 1 and 28 (predose and 0.5, 1, 2, 4, 6, 8, and 10 hours postdose)|All participants who received treatment were included in the pharmacokinetic (PK) analysis, however, due to various reasons (ie, missing samples at certain time points, or exclusion of specific plasma concentrations from the PK analysis) not all PK parameters could always be calculated for each participant.||ng/mL||Standard Deviation|Mean
128853|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) in each treatment group in Cohort 4, Panel C and in Cohort 5, Panel D with an SVR to treatment defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of the entire treatment regimen. SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively).|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128854|NCT00561353|Secondary|Sustained Virologic Response (SVR) in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with an SVR to treatment (defined as having an undetectable plasma level of HCV ribonucleic acid after the last planned dose of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). SVR was measured at 4, 8, 12, and 24 weeks after the last dose of treatment (SVR4, SVR8, SVR12, and SVR24, respectively). See treatment-naïve defined above."|SVR4 (Week 52), SVR8 (Week 56), SVR12 (Week 60), and SVR24 (Week 72)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128855|NCT00561353|Secondary|Viral Relapse in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants combined (non-responders and relapsers, see defined above) with viral relapse, defined as having confirmed detectable plasma level of HCV ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment who received TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-experienced and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.||Participants|||Number
128856|NCT00561353|Secondary|Viral Relapse in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|"The table below shows the number of treatment-naïve participants with viral relapse (defined as having confirmed detectable plasma level of HCV ribonucleic acid [RNA] during the follow-up period in participants with undetectable plasma HCV RNA [less than 25 IU/mL undetectable] at the end of treatment) for the treatment groups in Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined). See treatment-naïve defined above."|Up to Week 72|The analysis population used to evaluate viral relapse included participants in the intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) who were treatment-naïve and had undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.||Participants|||Number
128887|NCT00561015|Secondary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15|The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
128857|NCT00561353|Secondary|Viral Breakthrough in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128858|NCT00561353|Secondary|Viral Breakthrough in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1, Panel A and B)|The table below shows the number of treatment-naïve participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached, or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (less than 25 IU/mL undetectable) after treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on days 8, 15, and 22 (Panel A) and after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).|4 Weeks (Wks), 44 Wks, and 48 Wks|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses. Note: Number of participants analyzed during the PegIFNα-2a and ribavirin treatment period of up to 44 weeks is N=16 for TMC435 25 mg, N=17 for TMC435 75 mg, and N=17 for TMC435 200 mg.||Participants|||Number
128859|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with an initial suboptimal response defined as less than 2 log10 change of plasma in plasma level of HCV ribonucleic acid (RNA) at Day 2 or 3 (depending when visit was scheduled) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128860|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) after treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat (ITT) population, defined as all participants who were randomized and received at least one dose of study medication (TMC435) was used for all analyses.||Participants|||Number
128861|NCT00561353|Secondary|Initial Suboptimal Responses Following Treatment With TMC435 in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve participants with an initial suboptimal response defined as less than 2 log10 change in plasma level of hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 2 or 3 (depending when visit was scheduled) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22. See treatment-naive defined above."|Day 2 or 3|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128862|NCT00561353|Secondary|Virologic Response Parameters Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) treated with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12; a complete EVR (cEVR) defined as a EVR having undetectable plasma HCV RNA at Week 12; an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128863|NCT00561353|Secondary|Virologic Response Parameters in Treatment-Naïve Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A and B Combined)|The table below shows the number of treatment-naïve participants in the treatment groups for Cohort 1 (Panel A and B combined) and in Cohort 2 (Panel A and B combined) who met the following virologic response parameters: rapid virological response (RVR) defined as having undetectable plasma HCV ribonucleic acid (RNA) at Week 4; early virologic response (EVR) defined as change from baseline in plasma HCV RNA of greater than or equal to 2 log 10 at Week 12); a complete EVR (cEVR) defined as a complete EVR having undetectable plasma HCV RNA at Week 12); an extended RVR (eRVR) defined as undetectable plasma HCV RNA at Week 4 and 12; and a partial response defined as EVR but not reaching undetectability while on treatment.|Week 4 (RVR), Week 12 (EVR, cEVR, and partial response), and Week 4 and 12 (eRVR)|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128902|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B|"Blood drawn at Day 1 and Day 30 of the~extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
128864|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Experienced Hepatitis C Virus (HCV)-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the number of treatment-experienced participants (non-responders and relapsers, see defined above) with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. Note: in the table below, the number of participants (n) analyzed in the TMC435 200 mg (Cohort 4, Panel B) on Day 28 (Week 4) was n=4.|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128865|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel B)|"The table below shows the number of treatment-naive HCV-Infected participants with the following virologic responses to treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128866|NCT00561353|Secondary|Virologic Responses Following Treatment With TMC435 in Treatment-Naive Hepatitis C Virus (HCV)-Infected Participants (Cohort 1 and 2, Panel A)|"The table below shows the number of treatment-naïve HCV-infected participants treated with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 who had the following virologic responses: plasma levels of HCV ribonucleic acid (RNA) of greater than or equal to 2 log10 decline from Baseline; plasma levels of HCV RNA below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable); plasma levels of HCV RNA below the limit of detection (ie, <25 IU/mL undetectable); plasma levels of HCV RNA <100 IU/mL; and plasma levels of HCV RNA <1000 at the time points listed. See treatment-naive defined above."|Day 2 or 3, Day 7, and Day 28|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||Participants|||Number
128867|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
128868|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
128869|NCT00561353|Secondary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) on Day 7 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA on Day 7 (at Week 1) following treatment with TMC435 or placebo for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Day 7|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
128870|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-experienced participants considered non-responders (defined as participants who achieved less than a 2 log10 IU/mL decline from baseline in plasma HCV RNA levels after 12 weeks of previous interferon [IFN]-based therapy [pegylated or non-pegylated]) or relapsers (defined as a participant with undetectable plasma HCV RNA at the end of treatment of previous IFN-based therapy and subsequent confirmed detectable plasma HCV RNA levels during follow-up).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
128903|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
128871|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo coadministered with ribavirin for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
128872|NCT00561353|Primary|Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A)|The table below shows the change from Baseline in plasma levels of HCV RNA at Week 4 following treatment with TMC435 or placebo as for 7 days followed by TMC435 or placebo coadministered with ribavirin for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22 in treatment-naïve HCV-infected participants. (A treatment-naive participant is someone who has never taken drugs for their HCV infection).|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.||log10 IU/mL||Standard Error|Mean
128873|NCT00561340|Primary|Height Change|Change in height from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.||centimeters||Standard Deviation|Mean
128874|NCT00561340|Primary|Weight Change|Change in weight observed from baseline to 6 months|6 months|29 of 33 eligible subjects were enrolled. 4 subjects were not eligible for randomization as they were not appropriate candidates for caloric supplementation. Of the 13 randomized to Pediasure, 6 subjects refused to drink it. Data is presented for any subject who drank any Pediasure.||kilograms||Standard Deviation|Mean
128875|NCT00561145|Secondary|Expression of Genes Involved in Energy Metabolism||Before and after the energy restriction period.||||||
128876|NCT00561145|Secondary|Resting Energy Expenditure, Body Composition and Body Weight||Before and after the energy restriction period||||||
128877|NCT00561145|Secondary|Gastrointestinal Function||Before and after the energy restriction period||||||
128878|NCT00561145|Secondary|Appetite/Satiety Hormones and Questionnaires||Before and after the energy restriction period.||||||
128879|NCT00561145|Primary|Energy Intake Compensation|"To assess energy intake compensation, we will assess average energy intake during the ad libitum food intake phase - which is the period after energy restriction- in young men and compare this to average energy intake in older men.~Average energy intake is assessed by measuring total megajoule of energy intake during nine days of the ad lib phase, and then divide it by nine (MJ/day)"|Average intake of energy during ad lib phase (9 days)|completed (see publication)||MJ/day||Standard Deviation|Mean
128880|NCT00561015|Secondary|Percentage of Participants Who Achieved Sustained Virological Response (SVR)|The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Week 12, 24 after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||percentage of participants|||Number
128881|NCT00561015|Secondary|Percentage of Participants Who Demonstrated Virological Relapse|Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|24 weeks after EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||percentage of participants|||Number
128882|NCT00561015|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline, Day 12, 15 and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||percentage of participants|||Number
128883|NCT00561015|Secondary|Median Time to Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline up to EOT|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||days||Full Range|Median
128884|NCT00561015|Secondary|Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)|Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).|Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points.||percentage of participants|||Number
128996|NCT00560508|Secondary|Responder Rate For Patient Global Impression of Improvement (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||percentage of participants|||Number
128888|NCT00561015|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26|Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.|Baseline and Week 24/26|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||log10 IU/ml||Full Range|Median
128889|NCT00561015|Secondary|Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15|The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.|Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng*hr/ml||Standard Deviation|Mean
128890|NCT00561015|Primary|Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1|The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||hr||Full Range|Median
128891|NCT00561015|Primary|Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1|The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).|Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])|The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.||ng/ml||Standard Deviation|Mean
128892|NCT00561015|Primary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15|Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.|Baseline, Pre-dose (Day 15)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo.||log10 IU/ml||Full Range|Median
128893|NCT00561002|Other Pre-specified|Seroconversion Rates for Each Influenza Antigen Post-Vaccination|Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.|Day 14 post-vaccination|The seroconversion analysis were on the per-protocol immunogenicity population.||Percentage of Participants|||Number
128894|NCT00561002|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.|Day 14 post-vaccination|The serum hemagglutination inhibition antibody analysis were on the per-protocol immunogenicity population.||Percentage of Participants|||Number
128895|NCT00561002|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination||Day 0 and Day 14 after last dose of Fluzone|The Geometric Mean Titers analysis were on the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
128896|NCT00561002|Primary|Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation|Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.|Days 0-3 post-dose|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
128897|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
128898|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
128899|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
128900|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
128901|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8|"Blood drawn at Day 1 and Day 30 of the~extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA."|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
129898|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 52|At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).|52 Weeks|ITT Population||Percentage of Participants|||Number
128904|NCT00560950|Primary|Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3|Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.|Day 1 & Day 30|All eligible participants||gpELISA units/mL||95% Confidence Interval|Geometric Mean
128905|NCT00560937|Secondary|Mean Score on the Positive and Negative Symptom Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.|Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
128906|NCT00560937|Secondary|Clinical Global Impression Scale (CGI-I)|The CGI-I is a commonly used psychiatric scale to assess overall general improvement. The CGI-I consists of one interviewer-rated question on a scale of 1-7. Lower scores are indicative of fewer symptoms; while higher scores are indicative of more symptoms.|CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
128907|NCT00560937|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance.|Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
128908|NCT00560937|Primary|Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.|Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
128909|NCT00560937|Secondary|Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS is used measure to investigate depressive symptoms in schizophrenia. The measure includes 9 questions ranked from 0 (no symptoms) to 3 (severe symptoms). Range of possible scores: 0-27.|Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward)|||units on a scale||Standard Deviation|Mean
128910|NCT00560937|Primary|Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048|The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms).|SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)|Pilot proof of concept study||units on a scale||Standard Deviation|Mean
128911|NCT00560885|Secondary|Composite 6-month Post-procedure Major Adverse Event Rate.||6 Months Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.||percentage of subjects||95% Confidence Interval|Number
128912|NCT00560885|Secondary|Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Secondary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.||percentage of subjects||95% Confidence Interval|Number
128913|NCT00560885|Primary|Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.|30 days Post Procedure|Safety was evaluated in all subjects enrolled and treated with the device.||percentage of subjects||95% Confidence Interval|Number
128914|NCT00560885|Primary|Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.||6 Months Post Procedure|The analysis population included subjects that were evaluable for the Primary Efficacy Endpoint. The completer population excluded 5 subjects. These were 2 post op deaths, 2 deaths beyond 3 months but less than 6 months and 1 subject that withdrew at the 30 day visit.||percentage of subjects||95% Confidence Interval|Number
128915|NCT00560859|Secondary|Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale|Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.|7 months following baseline.|There was missing data for some children in the Watchful Waiting group since the Pediatric Sleep Questionnaire was not completed. Hence these numbers are not consistent with the rows in the participant flow module||units on a scale||Standard Deviation|Mean
128916|NCT00560859|Secondary|Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months|The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.|7 months following the baseline visit.|||Events per hour||Inter-Quartile Range|Median
128917|NCT00560859|Primary|Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.|The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.|The primary endpoint measure will occur at 7 months following the baseline visit.|||units on a scale||Standard Deviation|Mean
129381|NCT00557505|Other Pre-specified|Change From Baseline in Cytokine Concentration||Pre-dose (baseline), 1, 6 and 24 hrs after start of infusion on Day 1 cycle 1|Data was not analyzed, as development of the compound was terminated.||picogram (pg)/mL||Standard Deviation|Mean
128918|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||score on a scale||Standard Deviation|Mean
128919|NCT00560833|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||score on a scale||Standard Deviation|Mean
128920|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||number of events||Standard Deviation|Mean
128921|NCT00560833|Secondary|Change From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants receiving study drug with diary compliance adequate for this measure.||Score on a scale||Standard Deviation|Mean
128922|NCT00560833|Primary|Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The intent-to-treat (ITT) population, defined as all randomized particpants having at least one recorded pre-baseline value of the number of moderate and severe hot flushes.||Number of events||Standard Deviation|Mean
128923|NCT00560794|Secondary|Terminal Half-life of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||hours||Standard Deviation|Mean
128924|NCT00560794|Secondary|Clearance of Blinatumomab||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||L/hr/m²||Standard Deviation|Mean
128925|NCT00560794|Secondary|Apparent Volume of Distribution||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||L/m²||Standard Deviation|Mean
128926|NCT00560794|Secondary|Area Under the Drug Concentration-time Curve From Time Zero to Infinity||Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||hr*ng/mL||Standard Deviation|Mean
128927|NCT00560794|Secondary|Serum Blinatumomab Concentration at Steady State|The mean serum concentration of blinatumomab during cycle 1. The LOQ of the assay was 100 pg/mL, and the limit of detection (LOD) was 3 pg/mL.|Cycle 1 at predose and at 2, 6, and 12 hours after start of infusion then weekly until end of the cycle, and at 1, 2, 4, 6, 8, and 24 hours after stop of infusion.|Participants who received at least 1 infusion of blinatumomab with available pharmacokinetic data.||pg/mL||Standard Deviation|Mean
128928|NCT00560794|Secondary|Serum Cytokine Peak Levels in Cycle 1|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using fluorescence-activated cell sorter (FACS)-based cytometric bead array (CBA) system.The limit of detection (LOD) for the cytokine determination was 20 pg/mL, the limit of quantification (LOQ) was 125 pg/mL.|Cycle 1 at pre-dose and at post infusion start at 45 minutes; 2, 6, 12, 24, and 48 hours; 7, 14, 21, and 28 days.|Safety analysis set||pg/mL||Standard Deviation|Mean
128929|NCT00560794|Secondary|Change From Screening Value in T-cell Count During Cycle 1|T-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.||cells/μL||Standard Deviation|Mean
128930|NCT00560794|Secondary|Change From Screening Value in B-cell Count During Cycle 1|B-cells were measured by flow cytometry.|At Screening and in Cycle 1 at the start of infusion, 45 minutes, 2, 6, 12, 24 hours and at Days 2, 7, 14, 21, 28 and 35 after the start of infusion.|Participants who received blinatumomab with available pharmacodynamic data.||cells/μL||Standard Deviation|Mean
128931|NCT00560794|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of AEs was evaluated according to the grading scale provided in the Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, or according to the following: Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~A serious adverse event (SAE) is any untoward medical occurrence or effect that, at any dose results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. In addition, all laboratory abnormalities of grade four severity that occur during or after administration of the investigational drug, any overdose and a pregnancy or fathering were reported as SAEs."|From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.|Safety analysis set, including all participants who received ≥ 1 infusion of blinatumomab.||participants|||Number
128932|NCT00560794|Secondary|Time to MRD Relapse|"Time to MRD relapse is defined only for participants with an MRD response during the study, defined as the time between the date of the first MRD response and the date of MRD relapse. If a participant experienced hematological relapse without having shown MRD positivity before then the time point of MRD relapse is defined as the time point of hematological relapse. Participants without an event of MRD relapse or hematological relapse were censored on the day of their last available bone marrow aspiration/biopsy. If a participant received a bone marrow transplant the last day of bone marrow aspiration/biopsy before transplantation was used as time point for censoring.~MRD relapse is defined as reappearance of bcr/abl, and/or t(4;11) translocation at any detection level, and/or by individual rearrangements of immunoglobulin or T-cell receptor genes ≥10^-4 for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4 and should be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 116.5 days|Full analysis set||days||95% Confidence Interval|Median
128933|NCT00560794|Secondary|Time to MRD Progression|"Time to MRD progression is defined for participants who do not show MRD response at any time during the study as the time from start of first infusion until the first result of MRD progression or hematological relapse, if no MRD progression was diagnosed before hematological relapse. For participants who showed MRD response during the study the time to MRD progression is defined as the time from the date of the first MRD response to the date of MRD relapse. Participants without an event of MRD progression were censored on the day of their last bone marrow aspiration/biopsy. Participants who received a bone marrow transplant were censored on the last day of bone marrow aspiration/biopsy before transplantation.~MRD progression is defined as the increase in the MRD level by 1 log as compared to the baseline level (equal to a 10-fold increase in the number of MRD cells), and had to be confirmed within 6 weeks."|Up to the data cut-off date of 14 January 2010; Median follow-up time was 155 days|Full analysis set||days||95% Confidence Interval|Median
128934|NCT00560794|Secondary|Time to Hematological Relapse|"The time to hematological relapse is defined as the time between start of first infusion of blinatumomab and the first result of hematological relapse. Participants without an event of hematological relapse were censored on their last available date of bone marrow aspiration/biopsy.~Hematological relapse is defined as > 5% leukemia cells in bone marrow. Time to hematological relapse was analyzed using Kaplan-Meier methods."|Up to the data cut-off date of 14 January 2010; maximum duration of follow-up was 564 days.|Full analysis set||days||95% Confidence Interval|Median
128935|NCT00560794|Secondary|Percentage of Participants With an MRD Response After Each Treatment Cycle|"MRD Response is defined as:~If Philadelphia Chromosome (Ph)+ or t(4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.~If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|At the end of each treatment cycle - Weeks 4, 10, 16, and 22.|Full analysis set||percentage of participants||95% Confidence Interval|Number
128936|NCT00560794|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within 4 Cycles of Treatment|"MRD Response is defined as:~If Philadelphia Chromosome (Ph) positive (+) or translocation (t) (4;11), response was achieved when Ph or t(4;11) was below detection limit and individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4.~If Ph and t(4;11) negative, response was achieved when individual rearrangements of immunoglobulin or T-cell receptor genes are below 10^-4."|Within 4 treatment cycles, 24 weeks|Full analysis set||percentage of participants||95% Confidence Interval|Number
128937|NCT00560703|Primary|Change in Ocular Surface Disease Index (OSDI)|"OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4):~OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA)~Range of OSDI is 0 to 100 (higher score indicates worse condition)."|Baseline to Week 12|||Scores on a scale||Standard Deviation|Mean
129382|NCT00557505|Other Pre-specified|Change From Baseline in Leucocyte Subtypes||Baseline, Day 1 cycle 1, Day 1 Cycle 2, Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.||cells/mL|||Number
128938|NCT00560703|Primary|Change in Bulbar Conjunctival Hyperemia|"Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable:~None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness"|Baseline to Week 12|||Scores on a scale||Standard Deviation|Mean
128939|NCT00560612|Secondary|Sheehan Disability Scale (SDS)|"Rates the following (scale 1-10; 1= not at all, 10=extremely) Work, Social Life, Family Life/Home Responsibilities.~Perceived Stress and Social Supports Scale (scale 1-10; 1= not at all, 10=extremely) Perceived stress, perceived social support"|12 weeks||||||
128940|NCT00560612|Secondary|Symptom Checklist 90|"Individual symptom scales are determined (via computer scoring) as follows:~SOM - Somatization O-C - Obsessive-Compulsive I-S - Interpersonal Sensitivity DEP - Depression ANX - Anxiety HOS - Hostility PHOB - Phobic Anxiety PAR - Paranoid Ideation PSY - Psychoticism~Global Indices Global Severity Index (GSI): Designed to measure overall psychological distress.~Positive Symptom Distress Index (PSDI): Designed to measure the intensity of symptoms.~Positive Symptom Total (PST): Reports number of self-reported symptoms."|12 weeks||||||
128941|NCT00560612|Secondary|Clinical Global Impressions of Severity and of Improvement Scales|"The severity of illness is rated on a scale of 1-7; 1 being normal and 7 being among the most extremely ill patients.~Global improvement is similarly rated on a scale of 1-7; 1 being very much improved and 7 being very much worse."|12 weeks||||||
128942|NCT00560612|Secondary|Hospital Anxiety and Depression Scale|Separate depression and anxiety scores are determined from this measure. Possible ranges for both depression and anxiety scores: 0-21. 0-7 (normal); 8-10 (borderline abnormal); 11-21 (abnormal).|12 weeks||||||
128943|NCT00560612|Secondary|Connor Davidson Resilience Scale|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.|12 weeks||||||
128944|NCT00560612|Secondary|Short PTSD Rating Interview|"8 questions rated on 0-4 scale (0=not at all; 4=very much). One question assesses how much better the subject feels since beginning treatment (0-100; 0= no change; 100= very much change). Final question assesses how much symptoms have improved since starting treatment (forced choice: worse; no change; minimally; much; very much).~Total score is computed from questions #1-8 (range=0-32)."|12 weeks||||||
128945|NCT00560612|Primary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Baseline and 12 weeks|||Units on a scale||Standard Deviation|Mean
128946|NCT00560573|Other Pre-specified|Recommended Phase 2 Dose (RP2D)|The RP2D was determined after review and discussion by sponsor and investigators of the study data. Consideration was given to type and severity of toxicity as well as clinical suitability for long-term administration|Baseline to end of dose escalation, which was assessed in the last participant of the dose escalation portion of the study in Month 19|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.||mg/kg|||Number
128947|NCT00560573|Other Pre-specified|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level below the maximum administered dose which caused 0 or 1 out of 6 participants to experience a DLT in that given cohort at Cycle 1|Cycle 1, up to Day 21|Safety analysis set: All enrolled participants who received at least 1 dose of study medication.||mg/kg|||Number
128948|NCT00560573|Secondary|Serum Total Circulating Insulin-like Growth Factor (IGF-1) Levels|To monitor serum total IGF-1 levels as a potential pharmacodynamic response to figitumumab treatment|Baseline, Day 8, end of study|Biomarker analysis set: All enrolled participants who received at least 1 dose of study medication.||ng/mL||Inter-Quartile Range|Mean
128949|NCT00560573|Secondary|Percentage of Participants With Blood Anti-drug Antibody (ADA) Specific for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|30 min prior to figitumumab infusion in Cycle 1 and Cycle 4, end of study, fourth follow up visit (approximately 150 days after last dose)|ADA analysis set: All enrolled participants who received at least 1 dose of study medication.||Percentage of participants|||Number
128950|NCT00560573|Secondary|Duration of Response (DR)|For responding patients (CR and PR): Time from the date that CR or PR was first recorded to the date of the first documentation of progression|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|No analysis of this parameter was performed. Due to the exploratory nature of the study, the analysis of the efficacy of figitumumab was limited to the assessment of clinical benefit response and PFS.|||||
128951|NCT00560573|Secondary|Progression-Free Survival (PFS)|Time from the date of enrollment to date of documented disease progression, or death due to any cause|Screening, from Cycle 2 onwards CT scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.||months||95% Confidence Interval|Median
128952|NCT00560573|Secondary|Percentage of Participants With Objective Response or Prolonged Stabilization|Percentage of participants with a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 12 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants with non measurable disease were considered having a clinical benefit response only in the case of achievement of CR. Participants who developed early progressive disease post dosing and prior to response evaluation were considered to have progressed on study. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response|Screening, from Cycle 2 onwards computerized tomography (CT) scan done within 7-10 days prior to next cycle (approximately Day 15 of each cycle), follow-up (30 days after last study treatment dose)|Efficacy analysis set: All participants with measurable disease at baseline, receiving at lesast 1 dose of figitumumab with a response assessment made by the investigator according to the RECIST system.||Percentage of participants||95% Confidence Interval|Number
129306|NCT00558259|Secondary|Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period|Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.||Participants|||Number
128953|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Pemetrexed|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng*hr/L||Standard Deviation|Mean
128954|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed|Pemetrexed PK data was analyzed using noncompartmental methods. Plasma exposure parameters for pemetrexed were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0, 0.167, 1.167, 2.167, 4.167, 6.167, 24.167 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for pemetrexed 500 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng/mL||Standard Deviation|Mean
128955|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Gemcitabine|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng*hr/L||Standard Deviation|Mean
128956|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine|Gemcitabine PK data was analyzed using noncompartmental methods. Plasma exposure parameters for gemcitabine were analyzed in the absence (Cycle) 1 and presence (Cycle 2) of figitumumab|0 (pre-dose), 0.417, 1, 1.5, 2.5, 3.5 hr on Cycle 1, Day 1 and Cycle 2, Day 8|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng/L||Standard Deviation|Mean
128957|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Cisplatin|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence (Cycle 2) of figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||ng*hr/L||Standard Deviation|Mean
128958|NCT00560573|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin|Cisplatin PK data was analyzed using noncompartmental methods. Plasma exposure parameters for cisplatin were analyzed in the absence (Cycle 1) and presence of (Cycle 2) figitumumab|0 (pre-dose), 1.917, 2.5, 3, 4, 5, 24 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 75 mg/m^2 and 0 (pre-dose), 0.917, 1.5, 2, 3, 4, 23 hr on Cycle 1, Day 1 and Cycle 2, Day 1 for cisplatin 80 mg/m^2|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||nanogram (ng)/mL||Standard Deviation|Mean
128959|NCT00560573|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab|Concentration at the end of Cycle 4|0 (pre-dose) in Cycle 5 Day 1|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||mg/L||Standard Deviation|Mean
128960|NCT00560573|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Figitumumab PK data was analyzed using noncompartmental methods|0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 1 for dose escation and 0 (pre-dose), 1, 24, 72, 168, 336, 504 hr in Cycle 4 for expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||mg*hr/L||Standard Deviation|Mean
128961|NCT00560573|Secondary|Concentration at the End of Infusion (Cinf) for Figitumumab|Figitumumab pharmacokinetic (PK) data was analyzed using noncompartmental methods|Cycle 1 for dose escalation and Cycle 4 for dose expansion|PK analysis set: All enrolled participants who started treatment and had on-study samples to provide interpretable results.||mg/liter (L)||Standard Deviation|Mean
128962|NCT00560573|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Cycle 1 figitumumab attributed: Grade (Gr) 4 neutropenia (absolute neutrophil count <500 cells/cubic millimeter [mm^3]) >=7 days, febrile neutropenia (Gr 3, fever >=38.5 degrees Celsius), neutropenic infection (Gr 3 neutropenia, infection); Gr 4 thrombocytopenia (platelet <25,000 cells/mm^3), Gr 3 thrombocytopenia >=7 days/bleeding; other Gr 3 not blood/bone marrow Common Terminology Criteria for Adverse Events bar gastrointestinal toxicity, treatment-managed hyperglycemia/fatigue, hypersensitivity; Gr 3-4 hyperglycemia despite treatment; fail to adequately recover to continue study treatment|Start of treatment up to end of Cycle 1, Day 21|Safety analysis set: All enrolled participants in the dose escalation who received at least 1 dose of study medication.||participants|||Number
128963|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs)|The quantification of circulating tumor cells (CTCs)in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."||Number of CTC/ml of blood||Standard Deviation|Median
128964|NCT00560560|Secondary|Counts of Circulating Tumor Cells (CTCs) Expressing Positive Insulin-like Growth Factor 1 Receptor (IGF-1R)|The quantification of circulating tumor cells (CTCs) expressing the IGF-1R in this patient population. Blood samples were collected, and were measured using an automated microscope system.|Cycle 1 pre-dosing and Cycle 4 pre-dosing|"All enrolled participants who started treatment and who have at least one sample submitted. The total number of participants for this outcome measure was less than the original population. N means the numbers of units analyzed in Pre-treatment and/or Baseline, and Post-Baseline and/or Follow-up, respectively."||number of CTC expressing IGF-1R/ml blood||Standard Deviation|Median
129483|NCT00556998|Secondary|Cmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
128965|NCT00560560|Secondary|Participants Reporting Positive for Total Anti-drug Antibodies (ADA)|The immunogenicity of figitumumab in terms of producing an antidrug antibody (ADA) response were monitored.|Up to 2 hours prior to infusion in Cycles 1 and 4, at the end of treatment, and at the 4th scheduled follow-up visit (~150 days after the last infusion)|Participants for whom at least one ADA measurement was done. The outcome was not analyzed and only listing of ADA level for each participant was available.|||||
128966|NCT00560560|Secondary|Descriptive Summary of Figitumumab Concentration Versus Time|The measurement of mean plasma concentration of figitumumab in Day 1 of Cycle 1,2,3,4,5|Pre-dose on Day 1, 1 hour after end of infusion (post-dose) on Day 2 in Cycle 1, pre-dose on Day 1 in Cycles 2,3,4, 1 hour post-dose on Day 1 in Cycle 5|All participants for whom PK was assessed at least once. The numbers of participants analyzed are numbers of observation (non-missing concentrations). The numbers for 20 mg/kg group are 84,7,3,2,13 for five cycles, respectively. The numbers for 30 mg/kg group are 79,8,2,2,8 for five cycles, respectively.||miligrams/liter (mg/L)||Standard Deviation|Mean
128967|NCT00560560|Secondary|Percentage of Participants With Objective Response|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.|Baseline, every cycle (Day 15-21 or according to local standard), end of treatment (within 28 days of last dose of study drug) and follow-up (150 days after last dose of study drug), up to 33 months|Per protocol. All enrolled participants who started treatment, with measurable disease and adequate baseline assessment.||Percentage of participants||95% Confidence Interval|Number
128968|NCT00560560|Secondary|Progression-Free Survival (PFS)|The period from study entry until disease progression. Participants without progression or death were censored at time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of longest diameters of target measurable lesions, or a clear increase in a non-target lesion, or the apprearance of new lesions.|Baseline until tumor progression or censorship, up to 33 months. The frequency of tumor assessments was screening, every cycle, end of treatment (within 28 days of last dose of study drug), and follow-up.|All enrolled participants.||months||95% Confidence Interval|Median
128969|NCT00560560|Secondary|Overall Survival|The time from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|From date of enrollment until death or censorship, up to 33 months|All enrolled participants.||Months||95% Confidence Interval|Median
128970|NCT00560560|Primary|Estimate of the 6 Month Survival Probability|The 6 month survival probability was defined as the probability of survival at 6 months based on the Kaplan-Meier estimate. The time was from date of enrollment to date of death due to any cause. For participants who were last known to be alive, overall survival was censored at the last contact date.|Baseline up to Month 6|All enrolled participants.||Percent chance of survival||95% Confidence Interval|Number
128971|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
128972|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Error|Least Squares Mean
128973|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
128974|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
128975|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||mg per day||Standard Deviation|Mean
128976|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
128977|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
128978|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
129484|NCT00556998|Secondary|Tmax Following an IV Loading Dose||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
128979|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of on-time||Standard Deviation|Mean
128980|NCT00560508|Secondary|Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||Percentage of off-time||Standard Deviation|Mean
128981|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||percentage of participants|||Number
128982|NCT00560508|Secondary|Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|Baseline and after 64 weeks treatment|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Deviation|Mean
128983|NCT00560508|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)||percentage of participants|||Number
128984|NCT00560508|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)|Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)||percentage of participants|||Number
128985|NCT00560508|Secondary|Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)|Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)|Week 12 to Week 16|Full Analysis Set (FAS 2) for the open-label period||percentage of participants|||Number
128986|NCT00560508|Secondary|Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.|Week 12 to Week 16|Full Analysis Set (FAS 2) for open label period with observed case (OC)||UPDRS scores on a scale||Standard Error|Least Squares Mean
128987|NCT00560508|Secondary|Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment|Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration|from Visit 1 to Visit 8 after pramipexole ER|Full Analysis Set (FAS).||ng/mL|Participants|Standard Error|Mean
128988|NCT00560508|Secondary|Trough Plasma Concentration at Steady State|Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.|at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment|Full Analysis Set (FAS)||ng/ml||Standard Deviation|Geometric Mean
128989|NCT00560508|Primary|Percentage of Participants Who Experienced Adverse Events|An adverse event is defined as any untoward medical occurrence|12 weeks|Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.||percentage of participants|||Number
128990|NCT00560508|Secondary|Change From Baseline in L-dopa Daily Dose|The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||mg per day||Standard Error|Least Squares Mean
128991|NCT00560508|Secondary|UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||percentage of participants|||Number
128992|NCT00560508|Secondary|Change From Baseline in UPDRS Part IV Score|UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
128993|NCT00560508|Secondary|Change From Baseline in UPDRS Part III Score|UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
128994|NCT00560508|Secondary|Change From Baseline in UPDRS Part II Score|UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
128995|NCT00560508|Secondary|Change From Baseline in UPDRS Part I Score|UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
129604|NCT00556374|Secondary|Overall Survival|Overall survival (OS) determined by the time from randomization to death from any cause. OS will be analyzed after long-term follow-up is complete.|Participants will be followed for overall survival once every 12 months for 66 months after primary completion date.||10/2020||||
128997|NCT00560508|Secondary|Responder Rate For Clinical Global Impression of Improvement (CGI-I)|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||percentage of participants|||Number
128998|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia|Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
128999|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia|Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
129000|NCT00560508|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia|Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
129001|NCT00560508|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia|Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of on-time||Standard Error|Least Squares Mean
129002|NCT00560508|Secondary|Change From Baseline in Percentage Off-time|Percentage off-time during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||Percentage of off-time||Standard Error|Least Squares Mean
129003|NCT00560508|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and after 12 weeks treatment|Full Analysis Set (FAS) with last observation carried forward (LOCF)||UPDRS scores on a scale||Standard Error|Least Squares Mean
129004|NCT00560417|Secondary|Total Daily Insulin Dose at Endpoint (LOCF)||Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||Units of Insulin||Standard Deviation|Mean
129005|NCT00560417|Secondary|Change From Baseline in Body Weight at Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||kilograms||Standard Deviation|Mean
129006|NCT00560417|Secondary|Actual Body Weight at Baseline and Endpoint (LOCF)||Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||kilograms||Standard Deviation|Mean
129007|NCT00560417|Secondary|Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)|Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||episodes/participant/365 days||Standard Deviation|Mean
129008|NCT00560417|Secondary|Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)|Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.|Baseline to Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percentage of participants|||Number
129009|NCT00560417|Secondary|Glycemic Variability at Baseline and Endpoint (LOCF)|Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||mg/dL||Standard Deviation|Mean
129010|NCT00560417|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)|SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
129011|NCT00560417|Secondary|Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%||Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of participants|||Number
129012|NCT00560417|Secondary|Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
129013|NCT00560417|Secondary|Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.|24 weeks, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
129014|NCT00560417|Primary|Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])|Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.|Baseline, Endpoint (LOCF) up to 24 weeks|All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.||percent of glycosylated hemoglobin||Standard Error|Least Squares Mean
129015|NCT00560404|Secondary|Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40|Vital signs included blood pressure, pulse rate and body weight.|From Baseline to Week 40|The analysis was performed on safety population.||participants|||Number
129016|NCT00560404|Secondary|Number of Participants With Abnormal Changes in ECG From Baseline to Week 40|Twelve-lead ECG was performed.|From Baseline to Week 40|The analysis was performed on Safety population.||participants|||Number
129017|NCT00560404|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 40|The analysis was performed on Safety Population.||participants|||Number
129018|NCT00560404|Secondary|Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36|The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point..||International units/Liter||Standard Deviation|Mean
129019|NCT00560404|Secondary|Mean Values of Transferrin Saturation at Baseline and Week 36|The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||percentage||Standard Deviation|Mean
129020|NCT00560404|Secondary|Mean Values of Ferritin Concentration at Baseline and Week 36|Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||micrograms per liter||Standard Deviation|Mean
129021|NCT00560404|Secondary|Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36|The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||gram/litre||Standard Deviation|Mean
129022|NCT00560404|Secondary|Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36|Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||micromoles per liter||Standard Deviation|Mean
129023|NCT00560404|Secondary|Mean Values of Leukocytes and Platelets Count at Baseline and Week 36|The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||10^9/Litre||Standard Deviation|Mean
129024|NCT00560404|Secondary|Mean Values of Mean Corpuscular Volume at Baseline and Week 36|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||femtoliters||Standard Deviation|Mean
129025|NCT00560404|Secondary|Mean Values of Hematocrit at Baseline and Week 36|Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||fraction||Standard Deviation|Mean
129026|NCT00560404|Secondary|Mean Values of Hemoglobin Concentration at Baseline and Week 36|The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.|Baseline and Week 36|The analysis was performed on safety population. The “n” represents the number of participants analyzed at a specified time point.||g/dL||Standard Deviation|Mean
129027|NCT00560404|Secondary|Number of Participants Received Red Blood Cells Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.|Up to Week 28|The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not||participants|||Number
129028|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.||participants|||Number
129029|NCT00560404|Secondary|Number of Participants Who Required Dose Adjustments During the Dose Titration Period|The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.|DTP (Weeks 0 to 28)|The analysis was performed on ITT population.||participants|||Number
129030|NCT00560404|Secondary|Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period|Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.|EEP (Week 29 to Week 36)|The analysis was performed on ITT population.||days||Standard Deviation|Mean
129031|NCT00560404|Secondary|Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period|Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.|EEP (Weeks 29 to 36)|The analysis was performed on ITT population.||percentage of participants|||Number
129032|NCT00560404|Secondary|Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period|The Baseline (Safety Verification Period) was from Week - 4 to Week -1.|Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)|The analysis was performed on ITT population.||g/dL||Standard Deviation|Mean
129033|NCT00560404|Primary|Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period|The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.|EEP (Week 29 to Week 36)|Per-protocol population included participants who received at least one dose of C.E.R.A. and had data of at least one follow-up variable excluding those participants who had not adhere the inclusion/exclusion criteria, had less than 3 recorded Hb values, and received any other epoetin alpha and blood transfusion in Weeks 0 to 44.||percentage of participants|||Number
129034|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: <LLN – 8.0 mg/dL, GR2: <8.0 – 7.0 mg/dL, GR3: <7.0 – 6.0 mg/dL, GR4: <6.0 mg/dL. Calcium (High): GR1: >ULN – 11.5 mg/dL, GR2: >11.5 – 12.5 mg/dL, GR3: >12.5 – 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: <LLN – 1.2 mg/dL, GR2: <1.2 – 0.9 mg/dL, GR3: <0.9 – 0.7 mg/dL, GR4: <0.7 mg/dL. Phosphorus (low): GR1: <LLN – 2.5 mg/dL, GR2: <2.5 – 2.0 mg/dL, GR3: <2.0 – 1.0 mg/dL, GR4: <1.0 mg/dL. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
129035|NCT00560391|Secondary|Number of Participants With Minimal Response|Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
129036|NCT00560391|Secondary|Number of Participants With Partial Response|Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required.|Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
129037|NCT00560391|Primary|Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)|Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
129058|NCT00560235|Secondary|Plasma Concentration at End of Infusion (Cendinf)||Cycle 1 Day 2 and Cycle 5 Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.||mg/L||Geometric Coefficient of Variation|Geometric Mean
129038|NCT00560391|Primary|Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia|As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=<LLN(lower limit of normal)-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3:<2.0-1.0*10^9/L; GR4:<1.0*10^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9/L; GR2=<1.5-1.0*10^9/L; GR3:<1.0-0.5*10^9/L; GR4:<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3:<8.0-6.5g/dL; GR4:<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3:<50.0-25.0*10^9/L; GR4:<25.0*10^9/L. BL=Baseline; PBL=post baseline.|Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
129039|NCT00560391|Primary|Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.|Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
129040|NCT00560391|Secondary|Number of Participants With Complete Response and Very Good Partial Response|Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour.|Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||participants|||Number
129041|NCT00560391|Primary|Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone|The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)||participants|||Number
129042|NCT00560391|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination.|From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)||participants|||Number
129043|NCT00560391|Primary|Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)|The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.|From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).|All treated participants, participants who received at least 1 dose of dasatinib.||mg|||Number
129044|NCT00560352|Primary|MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||mg/m^2|||Number
129045|NCT00560352|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to or of unknown relationship to study treatment. Grade 3=severe; Grade 4=life-threatening.|Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone.||Participants|||Number
129307|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period|Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.|6 months|FAS and analysed as randomised.||Participants|||Number
129046|NCT00560352|Secondary|Progression-free Survival|Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population.|Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||Months||95% Confidence Interval|Median
129047|NCT00560352|Secondary|Duration of Response|Duration of response calculated for those with best response=CR (M-protein [MP] undetectable by immunofixation [IF], ≤5% plasma cells in bone marrow, no soft tissue plasmacytomas); VGPR (MP detectable by IF, or ≥90% drop in serum [S] MP and urine [U] MP<100 mg/24h); PR(≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size); or MR (≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC). Duration of response calculated from day criteria for CR, VGPR, PR, and MR were met until progression or death, whichever came first.|First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months)|All response-evaluable participants who achieved a response.||Months|||Number
129048|NCT00560352|Secondary|Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry|S=serum; U=urine; MP=M-protein; ST=soft tissue, PC=plasmacytomas; IF=immunofixation; BL=baseline. RR calculated on best response any time. CR=MP undetectable by IF, ≤5% plasma cells in bone marrow, and no ST PC. VGPR=MP detectable by IF, or ≥90% drop in S MP and U MP<100 mg/24h. PR= ≥50% drop in S MP and ≥90% drop in U MP or U protein <200 mg/24h, ≥50% drop in BL ST PC size. MR= ≥25% to <50% drop in S MP and ≥50% to <90% drop in U MP and ≥25% to <50% drop in BL ST PC. SD=Not CR, VGPR, PR, or MR. PD= ≥25% rise in S or U M-component; new/increased size of bone lesions, ST PC, or hypercalcemia.|Day 1 until last tumor assessment (maximum reached: 9 months)|All response-evaluable participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||Percentage of participants|||Number
129049|NCT00560352|Primary|Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone|MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.|Days 1 to 21|All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone||mg QD|||Number
129050|NCT00560313|Primary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.|The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.|One month after vaccinations|The analysis was done on the per protocol population.||participants|||Number
129051|NCT00560313|Primary|Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:~prior to the first vaccination~30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.||percentage||95% Confidence Interval|Number
129052|NCT00560313|Primary|Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.|Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.|One month after vaccinations|The analysis was done on the per protocol population.||titer||95% Confidence Interval|Geometric Mean
129053|NCT00560313|Primary|Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.|"Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:~prior to the first vaccination~30 days following the first, second, prior to the third and 30 days after the third vaccination"|One month after vaccinations|The analysis was done on the per protocol population.||percentage||95% Confidence Interval|Number
129054|NCT00560313|Primary|Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.|Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.|One month after vaccinations|The analysis was done on the per protocol population.||titer||95% Confidence Interval|Geometric Mean
129055|NCT00560235|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) Titer|Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer <6.64 corresponded to negative ADA category value.|Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)|All enrolled participants with ESFT and who started treatment with figitumumab. None of the serum samples were positive for ADAs following repeated administration of figitumumab, as indicated by an endpoint titer of <6.64.||participants|||Number
129056|NCT00560235|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.||mg*hr/L||Geometric Coefficient of Variation|Geometric Mean
129057|NCT00560235|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 1 cycle (4 weeks) in this study.|Cycle 5: 1 hour post-infusion on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.||milligram*hour per liter (mg*hr/L)||Geometric Coefficient of Variation|Geometric Mean
129059|NCT00560235|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin is the concentration at the end of treatment cycle (next cycle predose).|Cycle 6: predose on Day 1|The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.||mg/L||Geometric Coefficient of Variation|Geometric Mean
129060|NCT00560235|Secondary|Maximum Observed Plasma Concentration (Cmax)||Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1|The pharmacokinetic (PK) analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
129061|NCT00560235|Secondary|Overall Survival (OS)|Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment|All enrolled participants with ESFT and who started treatment with figitumumab.||months||95% Confidence Interval|Median
129062|NCT00560235|Secondary|Progression-Free Survival (PFS)|PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).|Baseline and every cycle (4 weeks), until progression or death|All enrolled participants with ESFT and who started treatment with figitumumab.||months||95% Confidence Interval|Median
129063|NCT00560235|Primary|Objective Response Rate (ORR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.|Baseline and every cycle (4 weeks), for up to 6 cycles|All enrolled participants with Ewing's sarcoma family of tumors (ESFT) and who started treatment with figitumumab; number of evaluable participants at data cut-off.||percentage of participants||95% Confidence Interval|Number
129064|NCT00560105|Secondary|Change in CCQ Score|The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.|8 weeks|A patient population included||units on a scale||Standard Deviation|Mean
129065|NCT00560105|Secondary|Quality of Life Questionnaire/Daily Diary|St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)|8 weeks|All patient data included||units on a scale||Standard Deviation|Mean
129066|NCT00560105|Secondary|FEV1 - Baseline and Device Comparisons|Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.|8 weeks|A data collected included||liter||Standard Deviation|Mean
129067|NCT00560105|Primary|Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight|In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.|8 weeks|All patient data included||g||Standard Deviation|Mean
129068|NCT00560066|Primary|Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV|Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.|From Day 1 up to and including Day 7 post-vaccination|Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.||Subjects|||Number
129069|NCT00560066|Secondary|Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.||Ratio||95% Confidence Interval|Geometric Mean
129070|NCT00560066|Secondary|Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV|Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.||Titers||95% Confidence Interval|Geometric Mean
129071|NCT00560066|Secondary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV|Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).|Three weeks post-vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.||Percentages of Subjects||95% Confidence Interval|Number
129210|NCT00558571|Secondary|Ae0-24 of Glucose|Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)|Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h|PD analysis set||mg||Geometric Coefficient of Variation|Geometric Mean
129072|NCT00560066|Secondary|Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV|Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).|Before vaccination (Day 1) and three weeks after vaccination (Day 22)|Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions (full analysis set [FAS]: all enrolled subjects who received a study vaccine and provided one evaluable serum sample before and after baseline)||Percentages of Subjects||95% Confidence Interval|Number
129073|NCT00560066|Secondary|Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.|From Day 1 through Day 7 post-vaccination|Analysis was done on the subset of safety population which included the adults and elderly with underlying medical conditions.||Subjects|||Number
129074|NCT00560066|Secondary|Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV|Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).|From Day 1 through Day 7 post-vaccination|Analysis was done on a subset of safety population (i.e. all subjects in the exposed population who provide postvaccination safety data) which included the healthy adults and elderly.||Subjects|||Number
129075|NCT00559988|Secondary|Rates of All-cause Mortality, Stroke (Ischemic and Hemorrhagic, Disabling and Non-disabling, Cardioembolic and Non-cardioembolic), and Major Bleeding, as Well as the AF Burden, Quality of Life, and Mean Heart Rate Reduction.|Secondary endpoints will be evaluated in a hierachical closed test procedure. If at the termination of the study, the result for the primary endpoint is found to have reached statistical significance, then Secondary Endpoints will be tested in turn for statistical significance at a 0.05 significance level. If at any stage, however, a non-significant result is found, no further testing of remaining secondary endpoints for statistical analysis will occur.|3 years||||||
129076|NCT00559988|Primary|Composite Primary Endpoint: Kaplan-Meier Estimate of Patients Without a Stroke, Systemic Embolism, or Major Bleed|The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.|From date of enrollment until date of primary endpoint event, assessed up to study exit, with a mean treatment duration of 2.0 years|Intent to treat analysis of all enrolled subjects||percentage of participants-Kaplan Meier|||Number
129077|NCT00559962|Secondary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT||Percent of Hepatic Fat||Standard Deviation|Mean
129078|NCT00559962|Primary|Absolute Change From Baseline in Percent Hepatic Fat|Absolute change from Baseline in percent hepatic fat|Baseline and 12 weeks on study drug|ITT||Percent of Hepatic Fat||Standard Deviation|Mean
129079|NCT00559949|Secondary|Overall Survival (OS)|Overall Survival using the Kaplan-Meier method with associated confidence intervals. OS analysis was intended to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants||months||95% Confidence Interval|Median
129080|NCT00559949|Secondary|Occurrence of Treatment Related Adverse Events|Number of participants with related adverse events, per category and Grade category. Toxicity assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|All participants||adverse events|||Number
129081|NCT00559949|Secondary|Median Progression-Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Secondary end points include toxicity, progression free survival, and overall survival. Due to the small sample size and absence of high quality historic data for this disease, these analyses were planned to be mostly exploratory and descriptive in nature.|Up to 2 years|All participants||weeks||95% Confidence Interval|Median
129082|NCT00559949|Primary|Objective Response Rate (ORR)|ORR: Complete Response (CR) and Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A conservative estimate of the response rate of the best-studied agent in this disease, doxorubicin, is approximately 5%. Therefore, investigators will assume that selumetinib (AZD6244, NSC 741078) would be worth further pursuit if the response rate (CR+PR) were at least 20%.|Up to 2 years|All evaluable participants||Participants|||Count of Participants
129083|NCT00559936|Primary|Ocular and Systemic Safety|The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.|All study visits|Participants treated with investigational medication were analyzed.||participants|||Number
129084|NCT00559936|Primary|The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.|The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.|Six Months|Participants who received investigational treatment were analyzed.||percent change since baseline||Standard Deviation|Mean
129085|NCT00559897|Primary|PET Response Rate||FLT PET scan will be done 6-8 days after the dose of zoledronic acid||||||
129086|NCT00559754|Secondary|Percentage of Participants With pCR by RKISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. RKISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129087|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129088|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. AGTR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129089|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pMAPK gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129090|NCT00559754|Secondary|Percentage of Participants With pCR by ENOS Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129091|NCT00559754|Secondary|Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. IGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129092|NCT00559754|Secondary|Percentage of Participants With pCR by HIF Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129093|NCT00559754|Secondary|Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. pAKT gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129094|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129158|NCT00559364|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which was collected from Day 1 to Day 4 or Day 5 during the inpatient period of treatment phase. Mean percent (%) CFA was calculated for Day 1 to Day 4 or Day 5 in inpatient period of treatment phase.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|Intent-to-treat (ITT) population included all randomized patients. Missing values at treatment phase were imputed using the median (50th percentile) of all non-missing values within a treatment group.||percent CFA||Standard Deviation|Mean
129095|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129096|NCT00559754|Secondary|Percentage of Participants With pCR by Angiotension Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Angiotensin protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129097|NCT00559754|Secondary|Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. ENOS protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129098|NCT00559754|Secondary|Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. HIF protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129099|NCT00559754|Secondary|Percentage of Participants With pCR by VEGFR Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEGFR protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129100|NCT00559754|Secondary|Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. VEFGR amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129101|NCT00559754|Secondary|Percentage of Participants With pCR by KISS1 Protein Expression|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129102|NCT00559754|Secondary|Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. KISS1 amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).|After Week 24 (surgery)|Only those participants evaluated for the specified biomarker were included in the analysis.||percentage of participants|||Number
129103|NCT00559754|Secondary|Percentage of Participants With pCR by Proliferation of Ki67|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria. It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes. Biomarker Ki67 proliferation was defined as low (less than [<]15% ) and high (≥15%).|After Week 24 (surgery)|Population evaluable for anatomopathological response with evaluable levels of the specified biomarker; data were missing for 2 participants.||percentage of participants|||Number
129104|NCT00559754|Secondary|Percentage of Participants With Breast-Conserving Surgery|Breast-conserving surgery was defined as lumpectomy + lymphadenectomy (LA), segmentectomy + LA, quadrantectomy + LA, or other (including sentinal node extirpation tumorectomy).|Week 24|ITT population; only those participants who underwent surgery were included in the analysis||percentage of participants|||Number
129211|NCT00558571|Secondary|LI (Linearity Index).|The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28|PK analysis set||ratio||Geometric Coefficient of Variation|Geometric Mean
129899|NCT00554099|Secondary|Recurrent Diverticulitis, Percentage, ITT Population, Week 12|At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).|12 Weeks|ITT Population||Percentage of Participants|||Number
129105|NCT00559754|Secondary|Percentage of Participants With Objective Clinical Response|Overall clinical response is the best response obtained through physical examination and/or radiological tests after completion of chemotherapy cycles. The percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) and was categorized as clinical response (CR+PR) or clinical benefit (CR+PR+ no change [NC]). Per RECIST, CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Within 28 days of enrollment, Weeks 12 and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
129106|NCT00559754|Primary|Percentage of Participants With Pathological Complete Response (pCR)|The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment. The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA). It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.|After Week 24 (surgery)|Population evaluable for anatomopathological response: participants who satisfied all inclusion criteria and none of the exclusion criteria, received at least 2 cycles of chemotherapy treatment, and were evaluated pathologically.||percentage of participants||95% Confidence Interval|Number
129107|NCT00559637|Secondary|Total Number of Red Blood Cell (RBC) Transfusions|RBC transfusions could be given during the study, if medically necessary, i.e., in participants with severe anemia with distinct symptoms or signs of anemia (such as in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).|Baseline to Month 9|ITT population||number of transfusions|||Number
129108|NCT00559637|Secondary|Total Number of Dose Adjustments|A dose adjustment was defined as a change versus the preceding dose. It included dose increase, dose reduction and dose interruption. An interruption (no dose given) was always counted as a dose adjustment, regardless of whether or not at the previous time point a dose had been administered. After an interruption a change in the dose relative to the dose given before the interruption was counted as a dose adjustment.|Baseline until Month 8|ITT population||dose adjustments|||Number
129109|NCT00559637|Secondary|Time to Increase of Hemoglobin Value to Over 11 g/dL|The duration (number of months) until the hemoglobin value exceeded 11 g/dL for the first time was summarized for participants for whom at least one measured hemoglobin value exceeded 11 g/dL.|Baseline to Month 9|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||months||Standard Deviation|Mean
129110|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-13 g/dL|The duration of hemoglobin values staying within the range of 11-13 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population||months||Standard Deviation|Mean
129111|NCT00559637|Primary|Change From Baseline in Hemoglobin Value to the Evaluation Phase|The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.|Baseline, evaluation phase (Months 8 and 9)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.||g/dL||Standard Deviation|Mean
129112|NCT00559637|Secondary|Duration of Hemoglobin Values in the Range of 11-12 g/dL|The duration of hemoglobin values staying within the range of 11-12 g/dL was defined as the number of (not necessarily consecutive) months with all corresponding hemoglobin values in the respective range. All months with missing hemoglobin values were counted as months where the hemoglobin value did not stay within the respective range.|Baseline to Month 9|ITT population||months||Standard Deviation|Mean
129113|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|ITT population||percentage of participants||95% Confidence Interval|Number
129114|NCT00559637|Primary|Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)|Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.|Evaluation phase (Months 8 and 9)|Intent to treat (ITT) population included all participants who received at least one dose of study medication with at least one hemoglobin value measured during treatment period.||percentage of participants||95% Confidence Interval|Number
129115|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory assessments were performed in the LT period at 12-week intervals and at a yearly visit and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
129289|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng.h/ml||Full Range|Median
129116|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign assessments were performed in the LT period at 12-week intervals and at a yearly visit (at 16-week intervals) and, for participants who withdrew from the study prematurely, 7 days after the last dose of SC abatacept. Vital signs included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
129117|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections, serious infections, and opportunistic infections; autoimmune disorders; malignancies; system injection reactions, and local injection site reactions.|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
129118|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)|All participants who entered the LT Period and received at least 1 dose of study drug during the LT Period.||participants|||Number
129119|NCT00559585|Primary|Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population|Serum samples from all treated adult participants with active rheumatoid arthritis who were from the Anti-TNF failure population were screened for the presence of drug-specific antibodies using Enzyme Linked Immunoabsorbant Assay (ELISA). The number of participants who had the presence of anti-abatacept antibodies or anti-CTLA-4 antibodies present in their serum are summarized.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants in the Anti-TNF Failure Sub-study who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||participants|||Number
129120|NCT00559585|Secondary|Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821|The disability section of the full HAQ includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI overall score ranges from a minimum of 0 to a maximum of 3.0. HAQ response was defined as an improvement (reduction) from baseline (Day 1) of at least 0.3 units in the HAQ score.|Days 169, 729, 1261, 1821|All participants who entered the LT period, received at least 1 dose of study drug during the LT period, and had HAD-QI scores at baseline and at specified days were summarized.||participants|||Number
129121|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
129122|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
129123|NCT00559585|Secondary|Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821|"The DAS28 index measures disease activity in rheumatoid arthritis and is a composite derived from the number of swollen/tender joints, laboratory tests of inflammation (C-reactive protein measured in mg/L), and participant assessment of global health (by marking a visual analog scale 100 mm line from very good to very bad). A higher DAS28 score indicates worse control of disease. High disease activity is > 5.1, low disease activity is < 3.2 and remission is < 2.6. A clinically significant response= decrease in DAS28 score of >1.2 from baseline."|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||units on a scale||95% Confidence Interval|Mean
129124|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
129125|NCT00559585|Secondary|Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Days 169, 729, 1261, 1821|All participants who entered the LT period and received at least 1 dose of study drug during the LT period were summarized.||participants|||Number
129126|NCT00559585|Secondary|Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||participants|||Number
129127|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; abatacept molecule). Ig and/or Junction (JNCT) category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a postbaseline titer higher than Baseline, or any postbaseline positivity if Baseline value was missing. Trt=treatment.|Days 85, and 169 and postvisits on Days 28, 56, and 85|All participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result reported during the short-term period.||participants|||Number
129128|NCT00559585|Secondary|Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period|C-reactive protein is an acute phase reactant protein that is a clinical marker for rheumatoid arthritis. Time-matched median percent change from baseline= (time-matched baseline value - Post-baseline value)/time-matched baseline value*100, where the time-matched baseline value represents the median baseline value for only that cohort of participants with measurements available at that visit.|Baseline to Days 15, 29, 57, 85, 113, 141, and 169|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||percent change||Inter-Quartile Range|Median
129129|NCT00559585|Secondary|Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept (anti-ABA) or anti-CTLA4 antibody (anti-CTLA4).|Days 85, and 169 and postvisits on Days 28, 56, and 85|All randomized participants who received at least 1 dose of study medication. n=Number of participants with at least 1 assessment available.||participants|||Number
129130|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) was measured as μg*h/mL. Samples for AUC (TAU) were obtained on Days 113, 120, 127, 134, and 141.|Dosing Interval between Days 113 and 141 (TAU=28 days)|Participants in the sub-study who received at least 1 dose of study medication and who had adequate PK profiles for analysis||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
129131|NCT00559585|Secondary|Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept||Dosing interval between Days 113 and 141 (TAU=28 days)|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis||µg*h/mL||Standard Deviation|Geometric Mean
129132|NCT00559585|Secondary|Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169. Cmax was measured in micrograms per milliliter (μg/mL).|End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants in the Sub-study who received at least 1 dose of study medication and who had adequate PK profiles were analyzed||μg/mL||Geometric Coefficient of Variation|Geometric Mean
129133|NCT00559585|Secondary|Double-blind Period: Maximum Observed Serum Concentration of Abatacept||End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous|Participants who received at least 1 dose of study medication and who had adequate PK profiles for analysis||µg/mL||Standard Deviation|Geometric Mean
129134|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept|Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in μg/mL. Samples were obtained on Days 57, 85, 113, 120, 127, 134, 141, and 169.|Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period)|Participants who received at least 1 dose of study medication and who had adequate PK profiles were analyzed. n= number of participants available at each specific time point.||μg/mL||Geometric Coefficient of Variation|Geometric Mean
129135|NCT00559585|Secondary|Double-blind Period: Minimum Observed Serum Concentration of Abatacept||Days 57, 85, 113, 120, 127, 134, 141, and 169|Participants who received at least 1 dose of study medication and from whom at least 1 pharmacokinetic (PK) sample was collected and reported (N). Only participants with adequate PK profiles were included in the summary statistics and statistical analysis (n).||µg/mL||Standard Deviation|Geometric Mean
129173|NCT00558896|Primary|The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)|"Response that was confirmed on 2 consecutive evaluations~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of study (up to 3 years)|||participants|||Number
129136|NCT00559585|Secondary|Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Sodium: <0.95*LLN/>1.05*ULN, or if BL<LLN, use <0.95* BL or >ULN, or if BL>ULN, use>1.05* BL or <LLN; potassium: <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN, use>1.1* BL or <LLN; chlorine: <0.9*LLN/>1.1* ULN, or if BL<LLN, use <0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN; calcium: <0.8* LLN/>1.2* ULN, or if BL<LLN, use <0.75*BL or >ULN, or if BL>ULN, use>1.25* BL or <LLN; phosphorous: <0.75* LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33* BL or <LLN|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. N=number of participants with assessments available.||participants|||Number
129137|NCT00559585|Secondary|Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN, use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-glutamyl transferase (GGT): >2* ULN, or if BL>ULN, use >3*BL; bilirubin: >2* ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2* BL; creatinine: >1.5*BL|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.||participants|||Number
129138|NCT00559585|Secondary|Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; BL= baseline. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; hematocrit: <0.75*BL; erythrocytes: <0.75*BL; platelets: <0.67*LLN/>1.5*ULN, or if BL<LLN, use <0.5*BL and <100,000 mm^3; leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN use <0.8*BL or >ULN, or if BL>ULN, use >1.2*BL or <LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication. n=Number of participants with assessments available.||participants|||Number
129139|NCT00559585|Secondary|Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements|Vital sign measurements were performed for participants before and after infusion/subcutaneous injection of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Day 1 through end of short-term period (Day 169)|All randomized participants who received at least 1 dose of study medication.||participants|||Number
129140|NCT00559585|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs: all infections,serious infections,and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (prespecified AEs occurring within 1 hr of start of infusion), peri-infusional AEs (prespecified AEs occurring within 24 hrs of the start of infusion), system injection reactions, and local injection site reactions|Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.||participants|||Number
129141|NCT00559585|Secondary|Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.||participants|||Number
129142|NCT00559585|Secondary|Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug|Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.|All randomized participants who received at least 1 dose of study medication.||participants|||Number
129143|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ-DI response=an improvement of at least 0.3 units from baseline in HAQ-DI.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available||participants|||Number
129144|NCT00559585|Secondary|Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0.|Baseline to Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.||units on a scale||Standard Error|Mean
129290|NCT00558272|Secondary|Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||h||Full Range|Median
129145|NCT00559585|Secondary|Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169|The disability section of the full HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. Higher scores=greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered.|Day 169|All participants who received at least 1 dose of study medication at any time and had HAD-QI scores available.||units on a scale||Standard Deviation|Mean
129146|NCT00559585|Secondary|Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169|The ACR 50 definition of improvement is a 50% improvement from baseline in the number of tender and swollen joint counts, and a 50% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein). ACR 70 is defined similarly with 70% improvements from baseline for tender and swollen joint counts and 3 out of 5 core measures.|Day 169|PP population, defined as participants who are compliant with the study criteria.||participants|||Number
129147|NCT00559585|Primary|Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).|Day 169|Per protocol (PP) population, defined as participants who are compliant with the study criteria.||participants|||Number
129148|NCT00559507|Secondary|Median Time to Treatment Failure||From the start of treatment up to 4 weeks after completion of study treatment|||Days||Full Range|Median
129149|NCT00559507|Secondary|Overall Response Rate (CR and PR)|Overall Response rate is defined as the sum of the complete response rate and partial response rate. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|From start of treatment to 24 weeks after completion of study treatment|||participants|||Number
129150|NCT00559507|Primary|Disease Control Rate (DCR)|DCR defined as complete response (CR), partial response (PR), stable disease (SD) > 24 weeks. Simon’s two-stage optimal design was used to estimate the DCR of AZD0530 after 24 weeks of therapy since this design allowed for early termination of the study. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|After 24 weeks of study therapy|||participants|||Number
129151|NCT00559377|Secondary|Response to XRT Using RECIST|Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols|time to disease progression or 2 years following first FMISO scan|PET/CT acquisition was obtained using non-diagnostic low dose CT attenuation scans at the time of PET/CT imaging that limited our ability to accurately measure tumor dimensions and due to lack of complete data, we were not able to fulfill this aim.|||||
129152|NCT00559377|Secondary|Relationship Between Ki67 and Regional FMISO Uptake in Tumor|The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Ki67 values were compared to FMISO uptake.||percentage of staining||Standard Deviation|Mean
129153|NCT00559377|Secondary|Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor|The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.|Up to 2 years|11 tissue samples with Hif1, VEGF, p53 and EGFR IHC values were compared to FMISO uptake.||units on a scale 0=low, 8=high||Full Range|Median
129154|NCT00559377|Primary|Disease-free Survival (DFS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.|Up to 2 years|Of the 13 patients analyzed for disease-free survival, 10 remained disease-free throughout the 2 year follow up. For 3 patients, we could determine overall survival, but could not confirm whether or not they were disease-free.||participants disease-free after 2 years|||Number
129155|NCT00559377|Primary|Overall Survival (OS)|Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.|For up to 2 years|1 patient has been lost to follow up for survival measures.||participants still alive after 2 years|||Number
129156|NCT00559364|Secondary|Percentage of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and watery. Percentage of stools of a specific consistency for each patient was calculated as: (total number of stools of specific consistency during the completed days of the inpatient period/ total number of stools during the completed days of the inpatient period)*100. Mean percentage of stool categorized as per consistency for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.||percentage of stools||Standard Deviation|Mean
129157|NCT00559364|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each patient was calculated from frequency of stools by the patient per day. Mean daily number of stools during the collection period (Day 1 to Day 4 or Day 5 in inpatient period of treatment phase) for total patients was summarized.|Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase|ITT population included all randomized patients.||stools per day||Standard Deviation|Mean
129159|NCT00559273|Secondary|Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response|The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population. Here, N=number of participants analyzed for this measure.||percentage of participants|||Number
129160|NCT00559273|Secondary|Percentage of Participants With Stable Hemoglobin Response|A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and >=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were >=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.|Baseline to Week 28|ITT population.||percentage of participants||95% Confidence Interval|Number
129161|NCT00559273|Secondary|Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL|Percentage of participants having at least one Hb value greater than (>) 12 g/dL during the first 8 weeks of the study was reported.|Baseline to Week 8|ITT population. Here, N=number of participants evaluable for this measure.||percentage of participants|||Number
129162|NCT00559273|Secondary|Percentage of Participants With Red Blood Cell (RBC) Transfusions|The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.|Baseline up to Week 28|ITT population.||percentage of participants|||Number
129163|NCT00559273|Secondary|Time to Hemoglobin Response|Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb >=1.0 g/dL from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without RBC transfusion before response.|Baseline up to Week 28|ITT population.||days||95% Confidence Interval|Median
129164|NCT00559273|Secondary|Hemoglobin (Hb) Concentration Over the Time|The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)|ITT population. Here, n=number of evaluable participants at specified time point, respectively for each group.||g/dL||Standard Deviation|Mean
129165|NCT00559273|Primary|Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)|ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.||g/dL||Standard Deviation|Mean
129166|NCT00559273|Primary|Percentage of Participants With Hemoglobin (Hb) Response|Hb response was an observed increase in Hb greater than or equal to (>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration >= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.|Baseline up to Week 28|Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.||percentage of participants||95% Confidence Interval|Number
129167|NCT00559104|Secondary|Short-term and Long-term Treatment-related Toxicities|Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.|Any time after transplant|per protocol||participants|||Number
129168|NCT00559104|Primary|Mortality|Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.|Assessed at date of death post-transplant|per protocol||participants|||Number
129169|NCT00559104|Primary|Progression|"Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first.~Below is reported Progression-free Survival: event is relapse or progression, or death."|Assessed at date of progression post-transplant|per protocol||participants|||Number
129170|NCT00559013|Primary|Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.||Discharge and 1 Month post surgery|||Participants|||Number
129171|NCT00558896|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.|Duration of study (up to 5 years)|Participants who achieved a partial response(PR) or better were evaluable for this analysis.||months||95% Confidence Interval|Median
129172|NCT00558896|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method.~Progression was defined as any one or more of the following:~25% increase in serum M-component (absolute increase >= 0.5g/dl)~25% increase in urine M-component (absolute increase >= 200mg/24hour~25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~25% increase in bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas"|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
129174|NCT00558870|Primary|Dose Escalation Index at Day 15 (+/- 3 Days)|Intended index period from baseline to Day 15 to determine whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15 (+/- 3 days). To determine whether the methadone group of individuals has a lower dose escalation index as compared to the morphine alone group: Participant dosages measured at baseline and daily until end of study (day 15), total daily dose of methadone converted to daily morphine equivalent daily dose for cancer pain and added to total daily morphine dosages. From these daily values, maximum dose recorded will be Opioid Maximum Dose (OMD). Opioid escalation index measured as described in Outcome 1 above (milligrams calculated by formula, (OMD-OSD)/days). Low index indicates achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time.|Day 15 (+/- 3 days)|No analysis possible due to small participation numbers.|||||
129175|NCT00558870|Primary|Number of Participants With Objective Response (OR)|Objective response (OR) is defined as a dose escalation index <20 where Opioid escalation index measured in milligrams is calculated by the formula, (OMD-OSD)/days, OMD = Opioid maximum dose as expressed in equianalgesic dose of oral morphine in milligrams, OSD= Opioid starting dose at the time of referral to palliative care/ pain specialist for the treatment of cancer pain as expressed in equianalgesic dose of oral morphine in milligrams. A low index indicates the achievement of adequate analgesia or appearance of uncontrollable side effects limiting upward titration over time. OR used in determining whether the addition of low dose methadone to morphine (in the methadone group) has a lower dose escalation index as compared to the morphine alone (in the morphine group) at Day 15.|Day 15 (+/- 3 days)|There were no participants analyzed in each group for outcome variable; the study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups.|||||
129176|NCT00558831|Primary|Subject Reported Change From Baseline Scale|"-1=worse 0=unchanged~1=mild improvement~2=moderate improvement~3=clear"|baseline and 1 month|||Participants|||Number
129177|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Specificity (%)|Participants||Number
129178|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Sensitivity (%)|Participants||Number
129179|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Specificity (%)|Participants||Number
129180|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Sensitivity (%)|Participants||Number
129181|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity [TN/(TN+FP)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Specificity (%)|Participants||Number
129206|NCT00558571|Secondary|Insulin Emax (Maximum Measured Effect)|change in Emax from baseline on day 28. Baseline is defined as day -1|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set||µU/mL||Standard Deviation|Mean
129207|NCT00558571|Secondary|Insulin AUEC0-5|change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set||µU*h/mL||Standard Deviation|Mean
129182|NCT00558792|Primary|Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity|For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity [TP/(TP+FN)] is presented.|Immediately post dose|Number of participants with significant disease (>50% stenosis)||Sensitivity (%)|Participants||Number
129183|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 3|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose|||Hounsfield Units||Standard Deviation|Mean
129184|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 2|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose|||Hounsfield Units||Standard Deviation|Mean
129185|NCT00558792|Primary|Contrast Density (CD) Measurements, Off-Site Reader 1|For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.|Immediately post dose|||Hounsfield Units||Standard Deviation|Mean
129186|NCT00558792|Secondary|Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater|Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.|up to 72 hours post dose|||Participants who Experienced AE(s)|||Number
129187|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose|||Segments Visualized Accurately|Participants||Number
129188|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose|||Segments Visualized Accurately|Participants||Number
129189|NCT00558792|Primary|Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1|For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.|Immediately post dose|||Segments Visualized Accurately|Participants||Number
129190|NCT00558753|Secondary|Knee Range of Motion (Active Flexion)||1-30 days|||Degrees||Standard Error|Least Squares Mean
129191|NCT00558753|Secondary|Neuropathic Pain (S-LANSS > 12)|Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(CRPS) at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. An S-LANSS score of 12 or more was an indication of chronic neuropathic pain. Patients with an Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) score of 12 or more at 6 mo came to the physician’s office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation.|3 and 6 months post-surgery|||participants|||Number
129192|NCT00558753|Primary|Epidural Medication Consumption Rate|Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use.|36 h|Because of structural missing data, sample sizes are smaller than the samples size for the secondary measure.||mL/h||Standard Deviation|Mean
129193|NCT00558701|Primary|Time to Wound Healing|Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing|20 days|||days||Full Range|Mean
129208|NCT00558571|Secondary|Mean Daily Glucose (MDG) Measured in Blood|change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27|PD analysis set||mg/dL||Standard Deviation|Mean
129209|NCT00558571|Secondary|Fasting Plasma Glucose (FPG)|fasting plasma glucose on day -1 (baseline) and change from baseline to day 28|in the morning of days -1 and 28|PD analysis set||mg/dL||Standard Deviation|Mean
129291|NCT00558272|Secondary|Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
129194|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 7|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 7 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.||Units on a scale||Standard Deviation|Mean
129195|NCT00558636|Secondary|Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5|HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL.|Change from baseline of HRQoL score assessed (at treatment Cycle 3 and Cycles 5 [21 days per cycle]) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret.||units on a scale||Standard Deviation|Mean
129196|NCT00558636|Secondary|Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2|The LCS is a validated instrument for determining treatment impact on lung symptoms. The LCS consists of 7 questions with 5 responses ranging from “not at all” to “very much”. The LCS total score ranges from 0 to 28. Lower scores reflect greater lung cancer symptoms.|Change from baseline of LCS score assessed at each treatment cycle starting with Cycle 2 (Cycles 2, 3, 4, 5, 6, 7; 21 days per cycle) up to 5 months after randomization of the first patient.|Of the 91 randomized subjects in the ITT population, 90 completed the LCS at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the response rate (number of evaluable subjects completing the questionnaire) decreased from cycle to cycle and makes the results hard to interpret.||units on a scale||Standard Deviation|Mean
129197|NCT00558636|Secondary|Duration of Response|Duration of response (PR or better) was defined as the time from the first documented objective PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Since only 4 subjects had a response, the duration of response was not calculated.|Time from first documented objective response (complete response or partial response) to disease progression or death, or to last tumor assessment if censored, up to 5 months after randomization of the first patient.|All subjects that showed a response. Since only 4 subjects had a response, the data were not analyzed.||days|||Number
129198|NCT00558636|Secondary|Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Complete response (CR): Disappearance of all target lesions (TL). Partial response (PR): At least 30% decrease in sum of the largest diameter (LD) of TLs, taking baseline sum as reference. Stable disease (SD): No change in tumor size. Progressive disease (PD): At least a 20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions.|Best tumor response assessed every 6 weeks by investigator during treatment up to 5 months after randomization of the first patient.|All randomized subjects (the intent to treat (ITT) population) were included in the analysis.||Participants|||Number
129199|NCT00558636|Secondary|Overall Survival (OS)|"Overall survival is the number of days from the date of randomization to the date of death due to any cause. Subjects alive at the time of analysis were censored at their last date of follow-up. Since the study was terminated early and 89% of subjects' data were censored, only the number of subjects who Failed (died) or were Censored is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|All randomized subjects (the intent to treat (ITT) population) were included in the analysis. Since 89% of subjects were censored, OS could not be calculated. The number of subjects who Failed (died) or were Censored are reported.||Participants|||Number
129200|NCT00558636|Primary|Progression Free Survival|"Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed [progressed or died before progression]) is reported, not the usual measure number of days."|Up to 5 months after randomization of the first patient|It was intended to include all randomized subjects (the intent to treat (ITT) population) in the analysis. Since 89% of subjects were censored, PFS could not be calculated. The number of subjects who Failed (progressed or died before progression) or were Censored are reported.||Participants|||Number
129201|NCT00558571|Secondary|HbA1c|change from baseline on day 28. Baseline is defined as day -1.|in the morning of days -1 and 28|PD analysis set||percentage of hemoglobin||Standard Deviation|Mean
129202|NCT00558571|Secondary|Fructosamine|change from baseline to days 14 and 18. Baseline is defined as day -1.|day -1 (baseline), 14 and 28|PD analysis set||µmol/L||Standard Deviation|Mean
129203|NCT00558571|Secondary|Glucagon AUEC0-5|Change from baseline (day -1) in AUEC0-5 on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Pharmacodynamic (PD) analysis set: All patients who receive at least one dose of study medication (active drug or placebo) and had some PD data were included in the pharmacodynamic analysis.||ng*h/L||Standard Deviation|Mean
129204|NCT00558571|Secondary|Glucagon Emax (Maximum Measured Effect)|Change from baseline (day -1) in Emax on day 28.|0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|PD analysis set||ng/L||Standard Deviation|Mean
129205|NCT00558571|Secondary|Fasting Insulin|Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.|in the morning of days -1( baseline), 1, 7, 14, 21 and 28|PD analysis set||µU/mL||Standard Deviation|Mean
129212|NCT00558571|Secondary|fe0-24 of Empagliflozin|Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set for patients who have fe data at day 1 and day 28||percentage of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
129213|NCT00558571|Secondary|CL/F of Empaglifozin|apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set||mL/min||Geometric Coefficient of Variation|Geometric Mean
129214|NCT00558571|Secondary|AUC0-∞ of Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss)|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1|PK analysis set||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
129215|NCT00558571|Secondary|t1/2 of Empagliflozin|terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set||hours||Geometric Coefficient of Variation|Geometric Mean
129216|NCT00558571|Secondary|Tmax of Empagliflozin|time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss.|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|PK analysis set||hours||Full Range|Median
129217|NCT00558571|Secondary|Cmax of Empagliflozin|maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28).|0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28|Pharmacokinetic (PK) analysis set: comprised all 62 patients who received Empagliflozin and had evaluable PK parameter data.||nmol/L||Geometric Coefficient of Variation|Geometric Mean
129218|NCT00558571|Primary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 6 weeks|treated set||participants|||Number
129219|NCT00558571|Primary|Number of Subjects With Drug Related Adverse Events|number of subjects with investigator-defined drug-related adverse events.|from drug administration up to 6 weeks|treated set: comprised all 78 patients who received at least one dose of study medication||participants|||Number
129220|NCT00558558|Primary|Change in Severity of Poor Appetite Following Treatment With Haelan (Fermented Soy Product)|Change in severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days.|Baseline and Week 4 +/- 5 days|The participants were not eligible for analysis based on the primary outcome timeline.|||||
129221|NCT00558467|Secondary|Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.||baseline and Week 6|Full Analysis Set (FAS).||participants|||Number
129222|NCT00558467|Secondary|Patient Global Impression at Week 6|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129223|NCT00558467|Secondary|Patient Global Impression at Week 4|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129224|NCT00558467|Secondary|Patient Global Impression at Week 3|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129225|NCT00558467|Secondary|Patient Global Impression at Week 2|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129226|NCT00558467|Secondary|Patient Global Impression at Week 1|Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129227|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 6|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129228|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 4|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129292|NCT00558272|Secondary|Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
129229|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 3|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129230|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 2|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129231|NCT00558467|Secondary|Clinical Global Impressions - Severity of Illness at Week 1|Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129232|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 6|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 6|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129233|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 4|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 4|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129234|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 3|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 3|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129235|NCT00558467|Secondary|Clinical Global Impressions - Improvement at Week 2|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 2|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129236|NCT00558467|Secondary|Clinical Global Impressions - Improvement at 1 Week|Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.|baseline and Week 1|The Full Analysis Set with last observation carried forward (LOCF).||Number of Patients|||Number
129237|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129238|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129239|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129240|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129241|NCT00558467|Secondary|Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6|Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)|baseline and 6 weeks|The Full Analysis Set with last observation carried forward (LOCF).||score on a scale||Standard Error|Least Squares Mean
129242|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 4 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129243|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 3 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129244|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline and 2 weeks|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129245|NCT00558467|Secondary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1|Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50|baseline 1 week|The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.||score on a scale||Standard Deviation|Mean
129246|NCT00558467|Primary|Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale|"Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.~Analysis was adjusted for baseline total tic score and age as linear covariates."|baseline 6 weeks|The Full Analysis Set (FAS) with last observation carried forward (LOCF).||score on a scale||Standard Error|Least Squares Mean
129247|NCT00558428|Primary|Number of Patients With Oedema|Patients from the treated set who experienced at least one case of general oedema.|During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)|The treated set (TS) consisted of all patients that took at least one dose of the double-blind treatment (n=1097)||patients|||Number
129248|NCT00558428|Secondary|Trough Seated Blood Pressure (BP) Normality Classes|"The number of patients who reach predefined BP categories:~Optimal - SBP<120 and DBP<80 mmHg~Normal - SBP<130 and DBP<85 mmHg~High-normal - SBP<140 DBP<90 mmHg~Stage 1 hypertension - SBP<160 and DBP<100~Stage 2 hypertension SBP>=160 and DBP>=100 mmHg"|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
129249|NCT00558428|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
129250|NCT00558428|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
129251|NCT00558428|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
129252|NCT00558428|Secondary|Trough Seated Diastolic Blood Pressure Control|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||patients|||Number
129253|NCT00558428|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)|Change from baseline to the end of study in trough SBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||mmHg||Standard Error|Least Squares Mean
129254|NCT00558428|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline to the end of study in trough DBP|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure||mmHg||Standard Error|Least Squares Mean
129255|NCT00558363|Secondary|Number of Participants With Threshold Vital Signs at Baseline and Any Time Post-baseline|Threshold vital signs are defined as follows: < 80 mmHg or > 165 mmHg for systolic blood pressure; < 40 mmHg or > 105 mm Hg for diastolic blood pressure, < 40 beats per minute (bpm) or > 100 bpm for heart rate.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one vital sign parameter were excluded from this analysis (6 in placebo arm, 4 in dutasteride arm).||participants|||Number
129256|NCT00558363|Secondary|Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline|Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.|Baseline; up to 28 months|ITT Population||participants|||Number
129257|NCT00558363|Secondary|Number of Participants With Nipple Tenderness (NT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for nipple tenderness. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with NT at baseline or NT at any time post-baseline were measured for clinical significance.||participants|||Number
129258|NCT00558363|Secondary|Number of Participants With Palpable Breast Tissue (PBT) at Baseline (BL) and Any Time Post-baseline|Participants underwent clinical examination of the breasts, to evaluate for palpable breast tissue. Clinical significance of the results was determined by subjective judgment of the clinical personnel performing the examination.|Baseline; up to 28 months|ITT Population. Only those participants with PBT at baseline or PBT at any time post-baseline were measured for clinical significance.||participants|||Number
129259|NCT00558363|Secondary|Number of Participants With a Threshold Laboratory Value for Any Parameter at Baseline (BL) and Any Time Post-baseline|Threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory’s normal range, pre-specified in the analysis plan. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal range is considered a low threshold value.|Baseline; up to 28 months|ITT Population. Participants not having a baseline as well as a post-baseline measurement of at least one laboratory parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).||participants|||Number
129260|NCT00558363|Secondary|Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study|A participant has a normal value for a laboratory parameter if the value is within the low and high range of normal provided by the laboratory. Each laboratory parameter is evaluated for shift from normal at baseline to abnormal any time post-baseline. A participant with any laboratory parameter showing this shift is counted. A participant is counted only once even if he had such a shift in more than one laboratory parameter or more than once among all post-baseline evaluations.|Baseline; up to 28 months|ITT Population. Participants not having any baseline measurements, or having a baseline but no post-baseline measurements of at least one of the same parameter could not be evaluated and were hence excluded from this analysis (7 in placebo arm, 9 in dutasteride arm).||participants|||Number
129261|NCT00558363|Secondary|Changes From Baseline in Disease-related Anxiety Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)|MAX-PC is an 18-item, self-reported measure that evaluates prostate cancer-related anxiety. The score ranges from 0 to 54, and an increase in the score indicates a worsened anxiety level. Change from Baseline at Month X = Month X MAX-PC score - Baseline MAX-PC score. A missing post-baseline value is replaced by the last available post-baseline value (Last Observation Carried Forward(LOCF)). A general linear model controls for previous therapy, site cluster, and baseline MAX-PC score.|Baseline; Months 3, 6, 12, 18, and 24|ITT Population. Participants not having a baseline value or not having any post-baseline value could not be evaluated for this endpoint and were hence excluded from this analysis (3 in placebo arm, 4 in dutasteride arm). Participants were excluded from a specific visit analysis if the value for the visit (after LOCF application) was missing.||scores on a scale||Standard Error|Least Squares Mean
129262|NCT00558363|Secondary|Number of Participants With the Indicated Change in PSA Doubling Time (PSADT) From Baseline at Month 12, Month 24, and End-of-treatment (up to 28 Months)|Participants with improvement included those whose PSADT at a specified visit was positive but more than the baseline PSADT, whose PSA at the visit was the same as the baseline PSA, or whose PSA at the visit was less than the baseline PSA. Participants with worsening included those whose PSADT at the visit was positive but less than the baseline PSADT.|Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months)|ITT Population. Participants having no baseline (BL) PSADT (due to incomplete PSA data or no rise in PSA at BL) or no post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 3 in dutasteride arm). Participants with missing PSA data at a specific visit were excluded from that visit’s analysis .||participants|||Number
129263|NCT00558363|Secondary|Percent Change in PSA From Nadir PSA at Months 12 and 24|Percent change from nadir PSA at Month X = 100*(Month X PSA – nadir PSA)/Nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||percent change||Standard Deviation|Mean
129264|NCT00558363|Secondary|Change in PSA From Nadir PSA at Months 12 and 24|Change from nadir PSA at Month X = Month X PSA – nadir PSA. Nadir PSA was reported by the site as the lowest historical PSA value after the radical therapy. A nadir value below the detection level was captured as 0.0. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||ng/ml||Standard Deviation|Mean
129265|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline During Year 1|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
129266|NCT00558363|Primary|Time to PSA Doubling From Baseline (in Days) Within Year 1|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.|up to 16 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Only participants with PSA doubling within Year 1 (50 in placebo, 15 in dutasteride) contributed to summary statistics.||days||Full Range|Median
129267|NCT00558363|Primary|Number of Participants With PSA Doubling From Baseline|PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
129268|NCT00558363|Secondary|Percent Change in Total PSA From Baseline at Months 12 and 24|Percent change in PSA from baseline at Month X = 100*(Month X PSA - Baseline PSA)/Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||percent change||Standard Deviation|Mean
129269|NCT00558363|Secondary|Change in Total PSA From Baseline at Months 12 and 24|Change in PSA from baseline at Month X = Month X PSA - Baseline PSA. The missing PSA value for scheduled visits could have been replaced by non-missing PSA values within 30 days after the clinic visit date. If such replacement was not possible, the latest non-missing post-baseline PSA before the scheduled visit was used for the scheduled visit PSA (Last Observation Carried Forward).|Baseline; Months 12 and 24|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||nanograms/milliliter (ng/ml)||Standard Deviation|Mean
129270|NCT00558363|Secondary|Number of Participants With PSA Progression|A participant was designated as having a PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was (>10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy) and PSA >=1.5 times the baseline PSA value), or 0<PSADT<=91 days, and all subsequent PSA values satisfied either of these criteria.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
129271|NCT00558363|Secondary|Time to PSA Progression (in Days)|A participant was designated as having PSA progression if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >10 ng/ml if radical prostatectomy or >20 ng/ml if primary radiotherapy and PSA >=1.5 times the baseline PSA value, or 0<PSADT<=91 days, and all subsequent PSA values satisfied these criteria. The study day for the first PSA qualifying for progression was used for time to PSA progression. If none of the PSA values qualified for PSA progression, time to PSA progression was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA progression have been summarized.||days||Full Range|Median
129272|NCT00558363|Secondary|Number of Participants With a PSA Rise From Baseline|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value.|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
129273|NCT00558363|Secondary|Time to PSA Rise From Baseline (in Days)|A participant was designated as having a PSA rise if there existed a post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was >1.15 times the baseline PSA value, and all subsequent PSA values were >1.15 times the baseline PSA value. The study day for the first PSA evaluation that qualified for analysis of PSA rise was used for time to PSA rise. If none of the post-baseline PSA values qualified for analysis of PSA rise during the study, time to PSA rise was censored at the last post-baseline PSA evaluation.|up to 28 months|ITT Population. Only those participants with PSA rise have been summarized.||days||Full Range|Median
129274|NCT00558363|Secondary|Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24|Treatment responders at Month X were defined as participants (par.) with either a PSA decrease or an increase <=15% from baseline to Month X confirmed in all PSA measurements between baseline (BL) and Month X.|Months 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Par. not having a post-BL measurement could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm). Different par. may contribute data at different time points (TP); the number of par. analyzed at each TP are those with BL as well as post-baseline data at the particular TP.||participants|||Number
129275|NCT00558363|Secondary|Number of Participants With Disease Progression|Disease progression is defined as the first occurrence of any of the following: PSADT<=91 days, PSA value is at least 50% more than baseline value (>20 ng/ml for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. If one of the PSA criteria is qualifying (within treatment period, typically up to 24-month evaluations), an immediate subsequent PSA, if available, must confirm either criterion (or at least 85% of the qualifying value).|up to 28 months|ITT Population. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm, 1 in dutasteride arm).||participants|||Number
129276|NCT00558363|Secondary|Time to Disease Progression From Baseline (in Days)|Time to disease progression is defined as the number of days between baseline and the first occurrence of any of the following: PSA doubling time (PSADT)<=91 days, PSA value is at least 50% more than baseline value (>20 nanogram/milliliter [ng/ml] for primary radiotherapy group or >10 ng/ml for radical prostatectomy group), rescue treatment, cancer-positive biopsy, cancer-positive bone scan. (Confirmation of PSA criteria is required in an immediate subsequent PSA, if available, and PSA values for consideration are restricted to treatment period, typically up to 24-month evaluations.)|up to 28 months|ITT Population. Only those participants with disease progression have been summarized.||days||Full Range|Median
129293|NCT00558272|Secondary|Saracatinib: Plasma Clearance at Steady State (CLss/F)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||L/h||Full Range|Median
129900|NCT00554099|Secondary|Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12||12 Weeks|ITT Population||Percentage of Participants|||Number
129277|NCT00558363|Primary|Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)|Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.|up to 28 months|ITT Population: all participants randomized to study treatment. Participants not having any post-baseline PSA measurements could not be evaluated and were hence excluded from this analysis (3 in placebo arm; 1 in dutasteride arm). Only participants who experienced PSA doubling (82 in placebo, 41 in dutasteride) contributed to summary statistics.||days||Full Range|Median
129278|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 14|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
129279|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 7|The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 7|Safety Population includes all patients who received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
129280|NCT00558285|Secondary|Change From Baseline in QTc (Fridericia's Formula) at Day 1|The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
129281|NCT00558285|Secondary|Trough Forced Vital Capacity (FVC) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Day 1 and Day 14|Participants from the Intent-to-treat Population (all randomized patients) with data available at the given time-point. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.||Liters||Standard Error|Least Squares Mean
129282|NCT00558285|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.|Day 1, Day 14|Intent-to-treat Population includes all randomized patients. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.||Liters||Standard Error|Least Squares Mean
129283|NCT00558285|Secondary|Change From Baseline in Mean 24 Hour Heart Rate at Day 1|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.|Baseline, Day 1|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.||beats per minute||Standard Error|Least Squares Mean
129284|NCT00558285|Primary|Change From Baseline in Mean 24 Hour Heart Rate at Day 14|Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.|Baseline, Day 14|Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.||beats per minute||Standard Error|Least Squares Mean
129285|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||h||Full Range|Median
129286|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||Ratio||Full Range|Median
129287|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
129288|NCT00558272|Secondary|N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)||Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng/ml||Full Range|Median
129294|NCT00558272|Secondary|Saracatinib: Area Under the Curve at Steady State (AUCss)|Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.|Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29|||ng•hr/ml||Full Range|Median
129295|NCT00558272|Secondary|Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in aaCTx/Cr||95% Confidence Interval|Geometric Mean
129296|NCT00558272|Secondary|Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in NTx/Cr||95% Confidence Interval|Geometric Mean
129297|NCT00558272|Secondary|Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in TRAP5b||95% Confidence Interval|Geometric Mean
129298|NCT00558272|Secondary|Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in PINP||95% Confidence Interval|Geometric Mean
129299|NCT00558272|Secondary|Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in ICTP||95% Confidence Interval|Geometric Mean
129300|NCT00558272|Secondary|Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in bALP||95% Confidence Interval|Geometric Mean
129301|NCT00558272|Primary|Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4|Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.|Baseline to Week 4|The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.||Percentage change in betaCTX||95% Confidence Interval|Geometric Mean
129302|NCT00558259|Secondary|Laboratory Measures, Especially Liver Function Tests (LFTs)|Number of participants with possible clinically significant abnormalities during the treatment period.|6 months|FAS − As Treated Assignment||participants|||Number
129303|NCT00558259|Secondary|Centrally Confirmed Cardiovascular Events During the Treatment Period|Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.||participants|||Number
129304|NCT00558259|Secondary|Centrally Confirmed Bleeding Event During the Treatment Period|"Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:~Fatal bleeding~Associated with a fall in haemoglobin of ≥2 g/dL~Led to the transfusion of ≥2 units packed cells or whole blood~Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal~Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.~Examples of these bleedings were:~Bleeding that compromised haemodynamics~Bleeding that led to hospitalisation~Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.~All bleeding events include MBEs, CRBEs, and trivial bleeding events."|6 months|FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.||participants|||Number
129308|NCT00558259|Secondary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|FAS and analysed as randomised.||Participants|||Number
129309|NCT00558259|Primary|Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period|Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.|6 months|Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.||Participants|||Number
129310|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|12 months|There were 59 participants who completed all follow-up visits and cosmetic evaluations.||Incisions with good outcome|||Number
129311|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|6 months|There were 60 participants who completed all follow-up visits and cosmetic evaluations.||Incisions with good outcome|||Number
129312|NCT00558246|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|90 days post-procedure|There were 60 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcome|||Number
129313|NCT00558246|Secondary|Time (Minutes) Required to Close the Final Skin Layer|Overall time required to close final skin layer on each breast.|Intraoperative|The analysis is based upon the Intent to Treat population.||minutes||Standard Deviation|Mean
129314|NCT00558246|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence was demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) did not exceed 12 percent.|12-25 days|The primary analysis is based upon intent to treat population.||Participants|||Number
129315|NCT00558103|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks|mITT1 and mITT2 Populations||months||90% Confidence Interval|Median
129316|NCT00558103|Secondary|Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks|mITT1 and mITT2 Populations||weeks||90% Confidence Interval|Median
129317|NCT00558103|Secondary|Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression|RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks|mITT1 and mITT2 Populations. Only participants who achieved a response of CR or PR during the study were analyzed. For participants who did not progress or die, duration of response was censored on the date of the last adequate assessment.||weeks||90% Confidence Interval|Median
129318|NCT00558103|Primary|Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions|RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.|Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study treatment. The mITT1 Population was used for cohort 1; the mITT2 Population used for cohort 2.||participants|||Number
131489|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Participants|||Number
129319|NCT00558064|Secondary|Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Treated set: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or A5 during the double-blind treatment period.||participants|||Number
129320|NCT00558064|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg~No: SBP >= 140 mmHg and DPB >= 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
129321|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
129322|NCT00558064|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
129323|NCT00558064|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
129324|NCT00558064|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of patients|||Number
129325|NCT00558064|Secondary|Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
129326|NCT00558064|Primary|Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing)|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
129327|NCT00558025|Secondary|Final Pramipexole Dose (mg) After 9 Weeks, Treated Set|The mean final daily Pramipexole dose is displayed|Week 9|Treated Set (TS) includes all patients randomized and who received treatment||mg||Standard Deviation|Mean
129328|NCT00558025|Secondary|Pramipexole Dose Adaptation, FAS (LOCF)|Patients with increase in daily Pramipexole dose on FAS|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||participants|||Number
129329|NCT00558025|Secondary|Patient Global Impression - Improvement (PGI-I), FAS (LOCF)|Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||participants|||Number
129330|NCT00558025|Secondary|Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)|Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'|Week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||participants|||Number
129331|NCT00558025|Secondary|Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Score on Scale||Standard Error|Least Squares Mean
129383|NCT00557505|Other Pre-specified|Change From Baseline in Circulating Tumor Cells (CTC) Concentration in Blood||Pre-dose (baseline), Day 8 cycle 1, Day 1 Cycle 2 and Day 1 of every other cycle starting from cycle 3 up to EOT or withdrawal|Data was not analyzed, as development of the compound was terminated.||cells/mL|||Number
129332|NCT00558025|Secondary|Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Score on Scale||Standard Error|Mean
129333|NCT00558025|Secondary|Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)|Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|Baseline and week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Score on scale||Standard Error|Least Squares Mean
129334|NCT00558025|Secondary|Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)|A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).|from baseline to week 4|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Percentage of participants|||Number
129335|NCT00558025|Primary|Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)|A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)|from baseline to week 9|Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint||Percentage of participants|||Number
129336|NCT00558012|Primary|Bone Mineral Density (BMD) of the Total Hip and Spine|BMD is the bone mineral density of the lumbar spine and total hip measured using dual-energy xray absorptiometry (DXA) scan|Baseline, 12 months, 24 month|Number of patients that completed a DXA at 12 months. At 24 months 60 in active treatment group and 72 in placebo group completed a DXA.||Percent change||Standard Error|Mean
129337|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|12 month|There were 49 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcome|||Number
129338|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|6 months|There were 50 participants who consented to and ultimately attended all follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcomes|||Number
129339|NCT00557947|Secondary|Cosmetic Outcome|"Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of incisions with good outcomes were then compared to those with poor outcomes.~Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675–85."|90 days post-procedure|There were 50 participants who consented to and ultimately attended follow-up visits for evaluation of cosmetic outcome.||Incisions with good outcome|||Number
129340|NCT00557947|Secondary|Time Required to Close the Final Skin Layer|Time to close final skin layer for each incision segment.|Intraoperative|The analysis is based upon the Intent To Treat population||minutes||Standard Deviation|Mean
129341|NCT00557947|Primary|Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|12-25 days post-operation|The primary analysis is based upon intent to treat population.||Participants|||Number
129342|NCT00557856|Other Pre-specified|Circulating Endothelial Cells (CEC)and Circulating Endothelial Progenitors (CEP): Part 1 and Part 2|Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Blood samples for the assessment of CECs and circulating CEPs were collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs. Circulating Cells were classified as CEPs if cluster differentiation 133 positive cells (CD133+) were detected.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Data was reported in individual participant listings but not statistically summarized due to statistical constraints.|||||
129343|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor Receptor Type 2 (VEGFR2), Vascular Endothelial Growth Factor Receptor Type 3 (VEGFR3)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGFR2, VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble Protein Biomarker Analysis Set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
129344|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Vascular Endothelial Growth Factor C (VEGF-C), Vascular Endothelial Growth Factor-d (VEGF-d), Vascular Endothelial Growth Factor Receptor Type 1 (VEGFR1)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (VEGF-C, VEGF-d, VEGFR1) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
129345|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Placental Growth Factor (PLGF), Transforming Growth Beta 1 (TGFB1), Vascular Endothelial Growth Factor A (VEGF-A)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (PLGF, TGFB1, VEGF-A) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
129346|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Cluster of Differentiation 106 (CD106), Cluster of Differentiation 54 (CD54), Endoglin]: Part 1 and Part 2|Plasma concentrations of soluble proteins (CD106, CD54 and Endoglin) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||pg/ml||Standard Deviation|Mean
129347|NCT00557856|Other Pre-specified|Soluble Protein Biomarker [Angiopoietin-2 (Ang-2), Bone Morphogenetic Protein-9 (BMP-9), Chemokine (C-C Motif) Ligand 2 (CCL2)]: Part 1 and Part 2|Plasma concentrations of soluble proteins (Ang-2, BMP-9, C-C motif) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity.|Baseline (pre-dose of C1D1), C1D1 6 hours post dosing, C1D22, C2D1, C3D1 and end of treatment (Day 490)|Soluble protein biomarker analysis set included all participants who received at least one dose of study drug with a baseline (pre-dose C1D1) or screening biomarker result, and at least one on-treatment biomarker result for at least one biomarker. “n” signifies those participants who were evaluable at specific time-point.||picogram/milliliter (pg/mL)||Standard Deviation|Mean
129348|NCT00557856|Other Pre-specified|Human Anti - Human Antibody (HAHA) Concentration: Part 1 and Part 2|HAHA concentration was analyzed in blood samples for the evaluation of immunogenicity of PF-03446962. HAHA concentration was reported for samples above lower limit of quantification (>=4.32).|Baseline up to 3 months after last dose|Statistical Data was not statistically summarized as majority of participants had concentration below the limit of quantification.|||||
129349|NCT00557856|Other Pre-specified|Plasma Decay Half-Life (t1/2): Part 1 and Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. As per planned analysis, t1/2 was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||hours||Standard Deviation|Mean
129350|NCT00557856|Secondary|Volume of Distribution: Part 1 and Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. As per planned analysis, volume of distribution was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||liter (L)||Standard Deviation|Geometric Mean
129351|NCT00557856|Other Pre-specified|Systemic Clearance(CL): Part 1 and Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body. As per planned analysis, CL was summarized if at least 3 participants had reportable value.|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||liter/hour (L/hr)||Standard Deviation|Geometric Mean
129352|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): Part 1 and Part 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||ng*hr/mL||Standard Deviation|Geometric Mean
129353|NCT00557856|Other Pre-specified|Area Under the Curve From Time Zero to Day 28 [AUC (0-28)]: Part 1 and Part 2|AUC (0-28) = Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 28 (0-28).|0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
129384|NCT00557505|Other Pre-specified|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective disease progression or death due to disease, whichever comes first.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.||weeks||Full Range|Median
129354|NCT00557856|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-03446962: Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure.||hour||Full Range|Median
129355|NCT00557856|Other Pre-specified|Minimum Observed Serum Trough Concentration (Cmin): Part 1 and Part 2||0 hr (pre dose), 1 hr post-dose C1D1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to C12|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962. Here “N” (Number of participants analyzed) signifies those who were evaluable for the measure and “n” signifies those participants who were evaluable at specific time-point.||ng/mL||Standard Deviation|Geometric Mean
129356|NCT00557856|Other Pre-specified|Maximum Observed Serum Concentration (Cmax): Part 1 and Part 2||0 hr (pre-dose),0.5,1,1.5,2,5,10,24 hr post-dose on Day (D) 1,3,5,8,11,15,22 of Cycle (C) 1, 0 hr,1 hr post-dose on Day 1 of subsequent cycles up to cycle 12, 28 days after last dose for dose (up to 3 months after last dose for >=2 mg/kg arms)|Pharmacokinetic analysis set included all participants who received at least one dose of study drug and who had complete sampling for pharmacokinetic profiles for PF-03446962.||nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
129357|NCT00557856|Secondary|Time To Progression (TTP): Part 2|Time in months from start of treatment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of treatment plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST). PD: >=20% increase in the sum of the LD of the target lesions taking as a reference the smallest sum of the LD or the appearance of one or more new lesions and as unequivocal progression of existing non-target lesions, or the appearance of >=1 new lesions. TTP was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Safety population included all participants who received at least one dose of study drug.||months||Full Range|Median
129358|NCT00557856|Secondary|Percentage of Participants With Disease Control: Part 2|Participants who achieved either a confirmed complete Response or confirmed partial response or a Stable disease lasting at least 12 weeks from the first dose was defined as achieving disease control. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all target lesions and non-target lesions. PR: >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD and stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest sum of the LD according to RECIST associated to non-progressive disease response for non-target lesions. Percentage of participants achieving disease control was calculated out of the participants participating in the exploratory phase.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who started Cycle 1 with an adequate baseline tumor assessment.||percentage of participants||90% Confidence Interval|Number
129359|NCT00557856|Secondary|Percentage of Participants With Objective Response: Part 1 and Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as disappearance of all target lesions and non-target lesions. PR defined as >=30 % decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions.|Baseline then 6 weeks after Cycle 1 of Day1 thereafter every 6 weeks up to Day 490|Response-evaluable set included all participants who received at least 1 dose of study drug with an adequate baseline tumor assessment.||percentage of participants||90% Confidence Interval|Number
129360|NCT00557856|Secondary|Number of Participants With Laboratory Abnormalities: Part 1 and Part 2|Laboratory tests included hematology (hemoglobin, lymphocytes absolute [abs], neutrophils abs, platelets, white blood cells) and chemistry (alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, lipase). Assays were based on National Cancer Institute [NCI] Common Terminology Criteria for AE (CTCAE) grading scale for AEs (grade 1 [mild AE: did not cause any significant problem, no dose adjustment required]; grade 2 [moderate AE: caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event]; grade 3 [severe AE: caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event] and grade 4 [life threatening AE]). Overall data of the 4 grades is reported.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
129361|NCT00557856|Secondary|Time to Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|Total time from onset of adverse event till the event is resolved. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Data for timing was reported in individual participant listing for every adverse event (AE) and mentioned for description of narrative of Serious AEs but was not statistically summarized for analysis on the entire safety population, as planned.|||||
129372|NCT00557622|Secondary|Number of Participants With a Clinical Global Impression (CGI) Global Improvement of 4 at Week 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1,Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse.|Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129362|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Seriousness: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed as serious adverse event (SAE) and non-serious adverse event (non-SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-SAE included all AE minus SAE. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
129363|NCT00557856|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity: Part 1 and Part 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 0 (no change from normal); grade 1 (mild AE which did not cause any significant problem, no dose adjustment required); grade 2 (moderate AE which caused problem that did not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event); grade 3 (severe AE which caused problem that interfered significantly with usual activities or the clinical status, study drug stopped due to adverse event); grade 4 (life threatening AE) and grade 5 (death). Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
129364|NCT00557856|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs): Part 1 and Part 2|An all causality AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs was any untoward medical occurrence in participant that was attributed to study drug. Treatment-emergent events were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cycle 1 of Day 1 up to 28 days after the last dose of treatment|Safety population included all enrolled participants who received at least one dose of study drug.||participants|||Number
129365|NCT00557856|Primary|Recommended Phase 2 Dose (RP2D): Part 1|RP2D was defined as the lower dose level to MTD based on the safety profile.|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.||mg/kg|||Number
129366|NCT00557856|Primary|Maximum Tolerated Dose (MTD): Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT and at least 2 out of 3/6 participants in the next higher dose. DLT was defined as any of the following events occurring during the first 42 days of study drug: any grade greater than or equal to 3 hematologic and non-hematologic toxicity, all non-disease-related adverse events (AEs).|Baseline up to 42 days after the start of each increased treatment dose|The MTD analysis set included all participants who were enrolled in the dose escalation part of the study and received at least 1 dose of study drug.||milligram/kilogram (mg/kg)|||Number
129367|NCT00557830|Post-Hoc|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the longest dimension (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever occurred first|||Months||95% Confidence Interval|Median
129368|NCT00557830|Secondary|Changes From Baseline in Symptom Burden|"The Patient Care Monitor Version 2.0 (PCM) is an tablet computer based assessment system that measures patient reported outcomes (PROs) in medical patients with a particular emphasis on symptoms related to cancer and its treatment.~The PCM comprises 86 items which include 8 items answered only by females (e.g. menstrual cramping). Each item is presented so that the patient rates the degree to which the item has been a problem in the past week (0 not a problem to 10 as bad as possible)."|The PCM was administered during screening, at each scheduled visit (approximately every 4 weeks), and at the end of treatment visit.|||units on a scale||Standard Deviation|Mean
129369|NCT00557830|Secondary|Overall Survival Rate|Due to the early study closure and the small sample size, overall survival rate was not evaluated.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 4 months thereafter until death.|Due to the early study closure and the small sample size, overall survival rate was not evaluated.|||||
129370|NCT00557830|Secondary|PFS Rate at 9, 13 and 17 Months|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.|PFS was to be measured at 9, 13, and 17 months.|Due to the early study closure and the small sample size, the PFS rate at 9, 13, and 17 months were not evaluated.|||||
129371|NCT00557830|Primary|Overall Response Rate (CR + PR) Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Response was evaluated via changes from baseline in radiological tumor measurements performed every 8 weeks and at the end of treatment unless clinically indicated prior to that. Confirmatory scans were to be obtained no less than 4 weeks but no more than 6 weeks following initial documentation of objective response. Response was evaluated using RECIST criteria, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions or the appearance of one or more new lesions.|Overall response will be measured at baseline and every 8 weeks , unless clinically indicated prior to that, until the end of treatment.|||Participants|||Number
129380|NCT00557505|Other Pre-specified|Change From Baseline in Tumor Proteins Related to P-cadherin Signaling and/or Tumor Proliferation or Apoptosis by Immunohistochemistry (IHC)||Baseline and cycle 3|Data was not analyzed, as development of the compound was terminated.||pg/mL||Standard Deviation|Mean
129373|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CGI (Clinical Global Impression) Severity of Illness Scores at Weeks 2, 4, 6, 8, 10, and 12|The participant's status was assessed using the following 8-point scale: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129374|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Increased Arousal Symptom at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129375|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Avoidance and Numbing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129376|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Relating Re-experiencing at Weeks 4, 8, and 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4, 8, and 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129377|NCT00557622|Secondary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder [PTSD] Scale One Week Symptom Status Version) Total Score at Weeks 4 and 8|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Weeks 4 and 8|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129378|NCT00557622|Secondary|Number of Participants With the Indicated Week 0 and Week 12 Z-scores for Regional Blood Flow Using Functional Magnetic Resonance Imaging (fMRI) in the Left Amygdala (LA), Right Amygdala (RA), and the Medial Prefrontal Cortex (MPFC)|Change in regional blood flow (rCBF) measured by fMRI represents altered neuronal responses in PTSD patients and is considered to be the biomarker for treatment response. fMRI measures are provided as blood oxygeneration level-dependent (BOLD) signals (z-score). To trigger neuronal activation, 2 visual stimuli were used: MVA-task (consisting of MVA-related and unpleasant pictures) and face-task (consisting of a variety of facial expressions [e.g., neutral, happy, fear]). Week 0 and 12 rCBF data from 1 participant were invalid (involuntary movement in the fMRI machine); no analysis was done.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129379|NCT00557622|Primary|Number of Participants With the Indicated Change From Baseline in CAPS-SX (Clinician-Administered Post Traumatic Stress Disorder (PTSD) Scale One Week Symptom Status Version) Total Score at Week 12|The Clinical-Administered PTSD Scale (CAPS) is a structured interview for assessing PTSD diagnostic status and symptom severity. The CAPS assesses both the frequency and intensity of individual PTSD symptoms on separate five-point (0-4) rating scales, and these ratings can be summed to create a nine-point (0-8) severity score for each symptom. The total CAPS score can range from 0 to 136, with a higher value indicating increased severity. A minus value for change from baseline indicates an improvement of symptom severity.|Baseline and Week 12|Full Analysis Set (FAS): All participants who received at least one dose of study medication for the treatment phase and had at least one post-baseline efficacy assessment. Participants who failed to satisfy major entry criteria measured prior to randomization (e.g., participant with disease other than PTSD) were excluded.||participants|||Number
129385|NCT00557505|Other Pre-specified|Change From Baseline in Standardized Uptake Values (SUV) of 18F-fluoro-3'-Deoxy-3'-L-fluorothymidine Positron Emission Tomography (FLT-PET)||Baseline, cycle 3 and after 8 weeks|Data was not analyzed, as development of the compound was terminated.||standardized uptake value (SUV)||Standard Deviation|Mean
129386|NCT00557505|Other Pre-specified|Human Anti-Human Antibody (HAHA) Levels|HAHA are indicators of immunogenicity to PF-03732010.|Pre-dose on Day 1 of Cycle 2 and Day 1 of every other cycle up to Week 4, 8 and 12 after the last dose or withdrawal|Data was not analyzed, as development of the compound was terminated.||microgram/mL||Standard Deviation|Mean
129387|NCT00557505|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with at least 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37|Data was not analyzed, as antitumor activity was not observed.||participants|||Number
129388|NCT00557505|Secondary|Apparent Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||Liter||Standard Deviation|Geometric Mean
129389|NCT00557505|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||Liter/hr||Standard Deviation|Geometric Mean
129390|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng*hr/mL||Standard Deviation|Geometric Mean
129391|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)]|AUC (0-14)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-14 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng*hr/mL||Standard Deviation|Geometric Mean
129392|NCT00557505|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng/mL||Standard Deviation|Geometric Mean
129393|NCT00557505|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||ng/mL||Standard Deviation|Geometric Mean
129394|NCT00557505|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||hr||Full Range|Median
129395|NCT00557505|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)]|AUC (0-28 day)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28 day).|0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal|Data was not summarized, as development of the compound was terminated.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
129396|NCT00557505|Primary|Recommended Phase-2 Dose (RP2D)||Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle|Data was not analyzed, as development of the compound was terminated.||mg/kg|||Number
129397|NCT00557505|Primary|Maximum Tolerated Dose (MTD)||Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle|MTD analysis population included all participants enrolled in the dose escalation part of the study who received at least 1 dose of study medication.||mg/kg|||Number
129398|NCT00557492|Secondary|Ca 19-9 Level (in Serum) - Biomarker Response|Percentage decrease in Ca 19-9 level (in serum)|Baseline and up to 48 months|Participants that did NOT demonstrate metastatic progression upon restaging CT.||percentage decrease in serum Ca19-9 leve||Standard Deviation|Mean
129399|NCT00557492|Secondary|Radiographic Tumor Response|CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)|Up to 48 months|||Participants|||Number
129400|NCT00557492|Secondary|Rate of Surgical Resection|Number of participants that underwent resection / per the total number of evaluable participants|Up to 48 months|||percentage of participants|||Number
129401|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes participants who underwent laparoscopy and pancreatic resection.||months||95% Confidence Interval|Median
129402|NCT00557492|Secondary|Progression-free Survival (PFS)||Up to 48 months|Includes entire study cohort.||months||95% Confidence Interval|Median
129405|NCT00557492|Primary|Rate of Pathologic Complete Response (pCR)|Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resections.||percentage of participants||95% Confidence Interval|Number
129406|NCT00557492|Primary|Rate of Margin Negative Surgical Resection (R0 Resection Rate)|Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.|Up to 48 months|Participants who underwent laparoscopy and pancreatic resection.||percentage of participants||95% Confidence Interval|Number
129407|NCT00557466|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat||participants|||Number
129408|NCT00557466|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period).|Intent to treat population. The analysis only includes patients with non-missing data.||liters/minute||Standard Deviation|Mean
129409|NCT00557466|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."||minutes||Standard Deviation|Mean
129410|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
129411|NCT00557466|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
129412|NCT00557466|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
129413|NCT00557466|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
129414|NCT00557440|Secondary|Forced Vital Capacity (FVC) at Single Time Points|"Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.~FVC was analyzed using ANCOVA adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.||liters||Standard Error|Least Squares Mean
129415|NCT00557440|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1 during the first 4 hours post-dose.~Time to peak FEV1 is based on log-transformed analysis of variance adjusted for treatment, period, sequence and center, with patient nested within sequence as a random effect. Geometric Mean was obtained by taking anti-logs of the adjusted means from the model and standard error was calculated using the delta method."|Up to 4 hours post-dose|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis.||minutes||Standard Error|Geometric Mean
130812|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Related to the Study Drug||Throughout the study period (1 year and 9 months)|All participants who received any study drug||Percentage of infusions|Participants||Number
129416|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was measured pre-dose and up to 24 hours post-dose. The FEV1 standardized area under the curve (AUC) was analyzed for four time intervals:~Baseline (pre-dose) to 4 hours (hr) post-dosing;~Baseline (pre-dose) to 23 hours, 45 minutes (min) post-dosing;~11 hours, 10 minutes to 12 hours, 30 minutes post-dosing;~11 hours, 10 minutes to 23 hours, 45 minutes post-dosing.~AUC for FEV1 was analyzed using Analysis of Covariance adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect."|Pre-dose, 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.||liters||Standard Error|Least Squares Mean
129417|NCT00557440|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.|Intent-to-treat population, where data were available. Patients who took rescue medication within 6 hours prior to spirometry measurements were excluded from the analysis. N indicates the number of participants with available data at each time point.||liters||Standard Error|Least Squares Mean
129418|NCT00557440|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|The Intent-To-Treat (ITT) population included all randomized patients who had at least one period containing a Baseline FEV1 measurement and at least one post-baseline measurement of FEV1 for the same treatment period. Patients who took rescue medication within 6 hours prior to the trough measurements were excluded from the analysis.||liters||Standard Error|Least Squares Mean
129419|NCT00557362|Secondary|Best Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate|Best hard contact lens-corrected visual acuity 3 months after enrollment was evaluated in a multiple linear regression model with enrollment hard contact lens-corrected visual acuity as a covariate. Visual acuity is reported in logMAR (logarithm of the Minimum Angle of Resolution).|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
129420|NCT00557362|Secondary|Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp).|Two subgroup analyses were conducted by causative organism: 1) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Fusarium ulcers; 2) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Aspergillus ulcers.|3 months from enrollment|This analysis looks at two different subgroups - Fusarium ulcers and Aspergillus ulcers. There were 44 Fusaruim ulcers enrolled in this trial and analyzed here, 23 of which were randomized to voriconazole and 21 to natamycin. There were 19 Aspergillus ulcers analyzed here, 8 of which were randomized to voriconazole and 11 to natamycin.||logMAR||95% Confidence Interval|Mean
129421|NCT00557362|Secondary|Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate.|Size of infiltrate/scar post-treatment was analyzed in a linear regression model using enrollment infiltrate/scar size as a covariate. No differentiation was made between infiltrate and scar when measuring infiltrate/scar size (measured in mm). For analysis, infiltrate/scar size was characterized by the geometric mean of the longest dimension and the longest perpendicular.|3 months from enrollment|||mm||95% Confidence Interval|Mean
129422|NCT00557362|Secondary|Time to Resolution of Epithelial Defect|Resolution of epithelial defect was defined as the absence of an epithelial defect with administration of fluorescein. The time to re-epithelialization was compared between the voriconazole and natamycin groups using the Cox proportional hazards model, adjusting for baseline epithelial defect size.|3 months from enrollment|||days||Standard Deviation|Mean
129423|NCT00557362|Primary|Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model|The primary efficacy endpoint was BSCVA at 3 months in the study eye, using a linear regression model with 3-month BSCVA measured in logMAR (logarithm of the Minimum Angle of Resolution) as the outcome variable and treatment arm (voriconazole vs natamycin) and enrollment logMAR BSCVA and corneal de-epithelialization (yes or no) as covariates.|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
129424|NCT00557349|Secondary|Number of Participants With Upper Endoscopy Indicated Due to Complaints|Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints|during first 14 weeks after surgery|Patients lost to follow-up were not included in the study analysis.||participants|||Number
129425|NCT00557349|Primary|Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.||during first 14 weeks after surgery|Patients lost to follow-up were not included in the data analysis.||participants|||Number
129426|NCT00557323|Secondary|Number of Study-emergent Deaths||5 years|Safety Set||Participants|||Number
129427|NCT00557323|Primary|Number of Study-emergent Bone-related Adverse Events (AEs)||5 years|Safety Set defined as all subjects who received at least one safety measurement during the study.||Bone-related AEs|||Number
129452|NCT00557284|Secondary|Mean Change in Serum and Urinary Inflammatory Marker Levels|Mean change in levels from baseline to study visit 4 (week 1 compared to week 9)for interleukin 3 (IL3), tumor necrosis factor alpha (TNF alpha), nerve growth factor (NGF), and urinary leukotriene E4 (LTE4)|Baseline and 9 weeks|||pg/ml||Standard Deviation|Mean
129428|NCT00557310|Secondary|Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint|CTX is a measure of bone resorption. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of nanogram/milliliter (ng/mL)||Standard Error|Least Squares Mean
129429|NCT00557310|Secondary|Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint|PINP is a measure of bone formation. Least squares (LS) mean of the percent change from baseline to 3, 6, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of microgram/Liter (µg/L)||Standard Error|Least Squares Mean
129430|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
129431|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
129432|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
129433|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/cm²||Standard Error|Least Squares Mean
129434|NCT00557310|Secondary|Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint|Areal BMD is a measure of the amount of mineral in a given area of bone. Least squares (LS) mean of the percent change from baseline to 18 and 24 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of g/square centimeter (g/cm²)||Standard Error|Least Squares Mean
129435|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of Newtons||Standard Error|Least Squares Mean
129436|NCT00557310|Secondary|Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint|Finite Element Analysis of computed tomography (CT) data from spine is used to estimate the strength of a vertebral body using a virtual axial load. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of Newtons||Standard Error|Least Squares Mean
129437|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of mg/cm³||Standard Error|Least Squares Mean
129438|NCT00557310|Secondary|Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint|Volumetric BMD is a measure of the amount of mineral in a given volume of bone, expressed as milligram per cubic centimeter (mg/cm³). Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of mg/cm³||Standard Error|Least Squares Mean
129453|NCT00557245|Secondary|Head Circumference Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up||z-score difference per study month|||Number
129439|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 3, 6, 12, 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 3, 6, 12, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
129440|NCT00557310|Secondary|Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint|BV/TV is the estimate of the ratio of detectable bone relative to the total volume of the region of interest. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
129441|NCT00557310|Secondary|Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint|TEI is the ratio of the sum of topological parameters expected to increase with bone erosion compared to the sum of those expected to decrease. The lower the value for TEI, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
129442|NCT00557310|Secondary|Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint|Cortical thickness (CT) is the thickness of both cortices in a given volume of bone. Least squares (LS) mean of the percent change from baseline to 18, 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of millimeter (mm)||Standard Error|Least Squares Mean
129443|NCT00557310|Secondary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 24 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 24 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||% change of ratio||Standard Error|Least Squares Mean
129444|NCT00557310|Primary|Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint|SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.|Baseline, 18 months|Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.||percent (%) change of ratio||Standard Error|Least Squares Mean
129445|NCT00557284|Secondary|Mean Change in (Gastrointestinal Symptom Rating Scale) GSRS|The mean change from baseline to study visit 4 (week 1 compared to week 9) in GRGS scores (GI symptoms will be recorded on *GSRS validated scale adjusted for pediatrics (*Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome and Peptic Ulcer Disease) for all subjects in each arm.This scale measures 7 different GI symptoms (1. abdominal pain; 2. nausea and vomiting; 3. abdominal dissention; 4. decreased passage of stools; 5. increased passage of stools; 6. loose stools; 7. hard stools) with severity ranges from 0 - 3 for each point (0 being no complaint and 3 being most severe for a maximum total of 21).|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
129446|NCT00557284|Primary|Mean Change in Weekly Use of Rescue Medication for AD Flare-up - Cetirizine and/or 10% Hydrocortisone Cream|Average of weekly use of cetirizine and/or 10% hydrocortisone cream will be compared for all subjects in each arm from week 1 to week 9. Flare-up is defined as a worsening of the disease that is unacceptable to the participants and leads to second line topical steroid use and/or liquid anti-histamine use. Measurement is noted as 1 for daily use (does not correspond to multiple uses per day).|Baseline and 9 weeks|||days/week||Standard Deviation|Mean
129447|NCT00557284|Primary|Mean Change in Pruritus|Mean change in pruritus scores from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Pruritus assessments (“itch”) will be recorded for the previous 24 hours using a 4 point-scale, ranging from none (0) to severe (3). Scores are cumulative per week.|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
129448|NCT00557284|Primary|Mean Change in PADC (Caregivers Perception of Disease Control)|Mean change in PADC from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. Caregiver’s evaluation of disease control over the previous 7 days and will consist of a four-point scale ranging from complete control (0) to uncontrolled disease (3)|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
129449|NCT00557284|Primary|Mean Change in Investigator Global Assessment (IGA)|The mean change in IGA from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm. The IGA is a six-point measure of disease severity and is evaluated by the investigator based on the overall assessment of skin lesions: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5= very severe.|Baseline and 9 weeks|||units on a scale||Standard Deviation|Mean
129450|NCT00557284|Primary|Change in Percentage of Body Involvement|Change in percentage of body involvement from baseline to study visit 4 (week 1 compared to week 9) for all subjects in each arm for AD as measured by study investigator|Baseline and 9 weeks|||Change of percentage in body involvement||Standard Deviation|Mean
131490|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 104||Week 104|ITT Population||Participants|||Number
129454|NCT00557245|Secondary|Weight Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up||z-score difference per study month|||Number
129455|NCT00557245|Secondary|Length Among Infants Born to Female Participants Taking Study Drug|The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month.|up to 12 months|Infants born to women taking study drug during follow-up||z-score difference per study month|||Number
129456|NCT00557245|Secondary|Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.|Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies.|Up to 36 months|Randomized female participants, less those found to be ineligible (n=7)||Number of live-born infants|Participants||Number
129457|NCT00557245|Secondary|Prevalence of Unprotected Sex During Follow-up|Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up.|Up to 36 months|All randomized participants, less those found to be ineligible (n=11).||percentage of visits|||Number
129458|NCT00557245|Secondary|Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up|"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.~N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)."|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)||participants|||Number
129459|NCT00557245|Secondary|Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC|"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.~Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)."|Up to 36 months|Participants who seroconverted during the Partners PrEP trial, including those who were retrospectively found to be HIV infected at enrollment (TDF arm: n=5; FTC-TDF arm: n=3; placebo arm: n=6). For 4 of 96 HIV-1 seroconverters (TDF arm: n=2; FTC-TDF arm: n=1; placebo arm: n=1) HIV-1 RNA was unable to be amplified for HIV-1 resistance testing.||Participants|||Number
129460|NCT00557245|Secondary|Study Drug Adherence: Self-reported Missed Doses of Study Drug|Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug.|Up to 36 months|Participants with self-reported adherence.||percentage of visits|||Number
129461|NCT00557245|Secondary|Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.|Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses.|Up to 36 months|||percentage of doses taken of dispensed|||Number
129462|NCT00557245|Primary|Number of Participants With Serious Adverse Events (SAEs)|Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up.|Up to 36 months|Randomized participants, less those found to be ineligible (n=11)||Participants|||Number
129463|NCT00557245|Primary|Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants|The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms.|Up to 36 months|All randomized participants, less those who were found to ineligible (n=11), less those found to be infected at enrollment (n=14), and less those who did not return for any follow-up (n=25).||events per 100 person years||95% Confidence Interval|Number
129464|NCT00557076|Secondary|Brainstem Auditory Evoked Potentials||End of Experimental Intervention||||||
129465|NCT00557076|Secondary|Functional Magnetic Resonance Imaging (fMRI)||Immediately after treatment ends||||||
129466|NCT00557076|Secondary|Coma Near Coma Scale|The CNC scale measures arousal and awareness and test stimuli are administered to elicit a specified behavior. Presence/absence of this behavior is scored as 0, 2 or 4. Total raw scores range from 0 (consistently responsive) to 36 (extreme coma). The CNC change score was calculated as the 8th CNC measure minus the Baseline CNC measure. Since 2 CNC measurements were collected per week, the 8th CNC measure occurred in Week 4. To calculate the change, we used the eighth CNC measure because two patients (one per group) recovered full consciousness after the eighth CNC measure. In the second statistical analysis, all CNC measures were used to calculate the slope; this includes the Baseline CNC and CNC measures 2-8. Again, we used the first 8 CNC measures (instead of all 12 collected over 6 weeks of treatment) because two patients recovered full consciousness after the eighth CNC measure.|Baseline and after the 8th CNC assessment (4 weeks after Baseline)|||units on a scale||Standard Deviation|Mean
129467|NCT00557076|Primary|DOCS Neurobehavioral Measure (DOCS = Disorders of Consciousness Scale) Change|The primary outcome, the DOCS, is a reliable, valid and precise measure of global neurobehavioral functioning shown to remain stable over six weeks.The DOCS-25 starts with a systematic observation followed by administration of 25 sensory stimuli. Best responses to each stimulus are rated on a scale of 0 to 2 and total raw scores range from 0 (worst) to 50 (best). The DOCS change was calculated as the value at endpoint (6 weeks after Baseline) minus the value at Baseline.|Baseline and immediately after treatment ends (6 weeks after Baseline)|||units on a scale||Standard Deviation|Mean
129468|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax 300 mg Oral Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing||||||
129469|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax Day 7 Oral All Participants|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of oral dosing||||||
129470|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of Intravenous dosing||||||
129471|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Loading Dose|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1||||||
129472|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral 300mg|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 oral dosing||||||
129473|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 Oral dosing||||||
129474|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 7 of IV dosing||||||
129475|NCT00556998|Other Pre-specified|Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1||||||
129476|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
129477|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
129478|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
129479|NCT00556998|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Full Range|Median
129480|NCT00556998|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
129481|NCT00556998|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
129482|NCT00556998|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.||μg/mL||Standard Deviation|Geometric Mean
130023|NCT00553319|Primary|ADHD Symptoms Based on ADHD Rating Scale|The proportion of subjects exhibiting >30% reduction of AISRS score at last enrollment week compared to week 0|measured once per week for 14 weeks or length of study participation|||participants|||Number
129485|NCT00556998|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
129486|NCT00556998|Primary|Tmax Following Oral Administration||Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
129487|NCT00556998|Primary|Cmax,ss Following Oral Administration||Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
129488|NCT00556998|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
129489|NCT00556998|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||hours||Full Range|Median
129490|NCT00556998|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.||μg/mL||Standard Deviation|Geometric Mean
129491|NCT00556998|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion|Intent to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.||μg*h/mL||Standard Deviation|Geometric Mean
129492|NCT00556972|Secondary|What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?||After application of product|||Pouche and Bag|Participants||Number
129493|NCT00556972|Secondary|Assessment of Skin 0-2 Inches From the Edge of the Anus|Skin condition scale: 1 = Normal skin without redness, 2 = Normal redness and intact skin, 3 = Abnormal redness but intact skin, 4 = Red and spotted but intact skin, 5 = Red and broken skin, 6 = Broken and bleeding skin Best skin condition score is 1, and worst skin condition score is 6.|Subjects were evaluated before and after test|ITT||Scores on a scale||Standard Deviation|Mean
129494|NCT00556972|Secondary|Is the Barrier Size and Shape Satisfactory|Percentage of subjects who answered yes to the question: is the barrier size and shape satisfactory|Subjects were followed for the duration of the study, an average of 23 hours|ITT||Percentage of subjects|||Number
129495|NCT00556972|Primary|The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)||5 days|ITT||Hours||Standard Deviation|Mean
129496|NCT00556946|Primary|Blanching of Port Wine Stain Birthmark||12 weeks|||participants|||Number
129497|NCT00556933|Secondary|Ratio of CD4/CD8 Lymphoid Cells||One year|||Ratio of cell counts||Standard Deviation|Mean
129498|NCT00556933|Secondary|New-onset Diabetes and Hyperglycemia After Transplantation (NODAT)||Six months|||participants|||Number
129499|NCT00556933|Secondary|New-onset Polyomavirus (BK Virus) Disease Per Kidney Biopsy||Two years|||participants|||Number
129500|NCT00556933|Secondary|Lymphoid Cell Sub-type CD3 Absolute Numbers||One year|||CD3 Cell Numbers/mm^3||Standard Deviation|Mean
129501|NCT00556933|Secondary|Patient Survival||Two years|||participants|||Number
129502|NCT00556933|Secondary|Graft Survival|Graft failure = permanent return of patient to dialysis.|Two years|||participants|||Number
129503|NCT00556933|Secondary|Acute Tubular Necrosis (ATN) Rate, Defined as the Requirement for Dialysis Within 7 Days Post-transplantation.||Seven days|||participants|||Number
129504|NCT00556933|Secondary|Acute Rejection Per Kidney Biopsy (Banff Grading Criteria)||Two years|||participants|||Number
129505|NCT00556933|Secondary|Requirement for Additional Immunosuppression (Such as Corticosteroids, Antimetabolites or Other Immunosuppressive Agents)||Two years|||participants|||Number
129506|NCT00556933|Secondary|Safety Profile|Number of events: cytomegalovirus (CMV) disease, opportunistic infections (bacteremia, abscess, pneumonia, fungal), Post-transplantation Lymphoproliferative Disorder (PTLD), wound healing problems within 30 days, and lymphoceles.|Two years|||Events|Participants||Number
129507|NCT00556933|Primary|Average of Renal Function|Calculated Glomerular Filtration Rate (GFR) by using the abbreviated MDRD (aMDRD) formula and patient serum creatinine and demographic data; averaged values from months four through 24.|Two years|||ml/min/1.73m2||Standard Deviation|Mean
129508|NCT00556933|Primary|Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading Criteria).|Protocol kidney biopsies collected at approximately 12 and 24 months were scored by a transplant renal pathologist blinded to treatment group assignment for evidence of rejection, BK virus nephropathy, antibody-mediated rejection, recurrent disease, inflammation, and Banff 2005 categories of chronic renal injury. Chronic injury categories were arteriolar hyaline thickening (ah), allograft glomerulopathy (cg), interstitial fibrosis (ci), tubular atrophy (ct), and vascular fibrous intimal thickening (cv). Severity scores within each category could be 0 (<5%; none or minimal), 1 (>5% - <25%; mild), 2 (>25% - <50%, moderate), or 3 (>50%, severe). The proportions of patients in each severity grade (0, 1, 2, and 3) for both the individual categories and a composite were compared using Fisher’s exact test.|Two years|||percentage of participants|||Number
129542|NCT00556712|Secondary|Percentage of All Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).|FAS||percentage of participants|||Number
129509|NCT00556894|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters|ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses|12 weeks||||||
129510|NCT00556894|Primary|ACR20|ACR20 response at endpoint at 12 weeks using non-responder imputation.|12 weeks|||participants|||Number
129511|NCT00556712|Secondary|Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
129512|NCT00556712|Secondary|Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)|"Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; n=number of participants assessed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
129513|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)|"Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS||percentage of participants||95% Confidence Interval|Number
129514|NCT00556712|Secondary|Time to Deterioration in QoL (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS||weeks||95% Confidence Interval|Median
129515|NCT00556712|Secondary|Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)|"Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively,||percentage of participants|||Number
129516|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)|"TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS||percentage of participants||95% Confidence Interval|Number
129517|NCT00556712|Secondary|Time to Deterioration in TOI (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS||weeks||95% Confidence Interval|Median
129518|NCT00556712|Secondary|Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)|"The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.||percentage of participants|||Number
129519|NCT00556712|Primary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129520|NCT00556712|Primary|PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS;only participants with EGFR IHC positive tumors were included in the analysis.||weeks||95% Confidence Interval|Median
129521|NCT00556712|Secondary|Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology."|6 months|FAS||percentage of participants||95% Confidence Interval|Number
129522|NCT00556712|Secondary|Time to Symptom Progression (Data Cutoff 17 May 2008)|"The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS||weeks||95% Confidence Interval|Median
129523|NCT00556712|Secondary|Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline."|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.||percentage of participants|||Number
129530|NCT00556712|Secondary|Time to Progression (Data Cutoff 17 May 2008)|The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.||weeks||95% Confidence Interval|Median
129524|NCT00556712|Secondary|Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)|Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129525|NCT00556712|Secondary|Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129526|NCT00556712|Secondary|Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)|Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129527|NCT00556712|Secondary|Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively.||percentage of participants||95% Confidence Interval|Number
129528|NCT00556712|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)|BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129529|NCT00556712|Secondary|Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)|TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
129531|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129532|NCT00556712|Secondary|OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||months||95% Confidence Interval|Median
129533|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants|||Number
129534|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129535|NCT00556712|Secondary|PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||weeks||95% Confidence Interval|Median
129536|NCT00556712|Secondary|Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)|FAS; only participants with EGFR IHC negative tumors were included in the analysis.||percentage of participants|||Number
129537|NCT00556712|Secondary|Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS||percentage of participants||95% Confidence Interval|Number
129538|NCT00556712|Secondary|OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||months||95% Confidence Interval|Median
129539|NCT00556712|Secondary|Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)||Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||percentage of participants|||Number
129540|NCT00556712|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|1 year|FAS||percentage of participants||95% Confidence Interval|Number
129541|NCT00556712|Secondary|Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)|FAS||months||95% Confidence Interval|Median
129601|NCT00556400|Secondary|Total Number of Bleeding Days During the First 7 Days.||1 week|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
129543|NCT00556712|Primary|Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; only participants with EGFR IHC positive tumors were included in the analysis.||percentage of participants|||Number
129544|NCT00556712|Primary|Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)|PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.|6 months|FAS; participants with PD prior to randomization were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
129545|NCT00556712|Primary|PFS in All Participants (Data Cutoff 17 May 2008)|The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.||weeks||95% Confidence Interval|Median
129546|NCT00556712|Primary|Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)|Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.|Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)|FAS; participants with PD prior to randomization were excluded from analysis.||percentage of participants|||Number
129547|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||hours||Full Range|Median
129548|NCT00556673|Secondary|Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||hours||Full Range|Median
129549|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg/mL||Standard Deviation|Mean
129550|NCT00556673|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg/mL||Standard Deviation|Mean
129551|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg*h/mL||Standard Deviation|Mean
129552|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg*h/mL||Standard Deviation|Mean
129553|NCT00556673|Secondary|Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate||Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.|All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.||pg*h/mL||Standard Deviation|Mean
129554|NCT00556673|Secondary|Change From Period Baseline in Peak FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||ratio||90% Confidence Interval|Least Squares Mean
129555|NCT00556673|Secondary|Change From Period Baseline in Trough FEV1/FVC Ratio|The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population||ratio||90% Confidence Interval|Least Squares Mean
129556|NCT00556673|Secondary|Change From Period Baseline in Peak Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||liters||90% Confidence Interval|Least Squares Mean
129557|NCT00556673|Secondary|Change From Period Baseline in Trough Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population||liters||90% Confidence Interval|Least Squares Mean
129558|NCT00556673|Secondary|Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||Percent of predicted||90% Confidence Interval|Least Squares Mean
129559|NCT00556673|Secondary|Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|"Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate."|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population||Percent of predicted||90% Confidence Interval|Least Squares Mean
129560|NCT00556673|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Pharmacodynamic population||liters||90% Confidence Interval|Least Squares Mean
129561|NCT00556673|Primary|Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.|Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Pharmacodynamic population included all patients randomized that received at least one dose of study drug and completed the first two treatment periods with evaluable data for the primary efficacy variable, and with no major protocol deviations. 7 patients who were inadvertently unblinded by the investigator were excluded from the PD analysis.||liters||90% Confidence Interval|Least Squares Mean
129562|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||PRI||Standard Deviation|Mean
129563|NCT00556543|Primary|The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)|The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||PPI||Standard Deviation|Mean
129564|NCT00556543|Primary|The Rand 36-Item Health Survey Results - General Health Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129565|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Bodily Pain Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129602|NCT00556400|Secondary|Proportion Who Stop Uterine Bleeding by Day 14.||2 weeks|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.|||||
130104|NCT00552240|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity||baseline to week 52|All treated patients||participants|||Number
129566|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Social Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129567|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Emotional Well-being Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129568|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Vitality Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129569|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129570|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129571|NCT00556543|Primary|The Rand 36-Item Health Survey Results - Physical Functioning Scale|The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.|results at 60, 120, and 180 days post-repair with results posted for 180 days|Per Protocol||RAND-36 scale units||Standard Deviation|Mean
129572|NCT00556543|Primary|Adverse Post-op Events Related to the Repair and Plating System|Clinical evaluations or chest radiographs at a minimum of 1 and 6 months|180 days|Per Protocol||Participants|||Number
129573|NCT00556504|Secondary|Immune Cell Normalization|Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)|||participants|||Number
129574|NCT00556504|Secondary|Immune Cell Normalization|"Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment~(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)"|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
129575|NCT00556504|Secondary|Combined ALT and Virologic Response|Combined ALT and virologic response at the end of combination drug treatment.|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
129576|NCT00556504|Secondary|Sustained ALT Response|a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.|24 weeks after the termination of combinational drug treatment (up to 72 weeks)|||participants|||Number
129577|NCT00556504|Secondary|ALT Response|"An ALT response is defined as normalization of ALT at the end of combination drug treatment.~(ALT normalization is defined as ALT level decreases into within the normal range)"|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
129578|NCT00556504|Secondary|Virologic Response|"undetectable HCV RNA at the end of combination drug treatment~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)."|at the end of combination drug treatment (up to 48 weeks)|||participants|||Number
129579|NCT00556504|Primary|Sustained Virologic Response (SVR)|"SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..~A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.~If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.~If the patient’s HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.~Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)"|24 weeks after the termination of combinational drug treatment (up to 72 weeks)|||Number of participants with SVR|||Number
129580|NCT00556491|Secondary|Composite End-point of Secondary Outcomes of Death, Hospital Days, Major Complications||30 days post-operative||||||
129581|NCT00556491|Primary|Development of Post-operative Acute Kidney Injury|Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively|up to 5 days post cardiac surgery|||participants meeting primary oputcome|||Number
129582|NCT00556478|Secondary|Partner Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3.|3 months|ITT||percentage of partners|||Number
129583|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 3|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3.|3 months|ITT||percentage of participants|||Number
129584|NCT00556478|Secondary|Subject Premature Ejaculation Profile (PEP) at Month 2|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2.|2 months|ITT||percentage of participants|||Number
129585|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|2 months|ITT||Score||Standard Deviation|Mean
129586|NCT00556478|Secondary|Subject PEP at Month 1|Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1.|1 month|ITT||percentage of participants|||Number
129587|NCT00556478|Secondary|Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1|"Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1.~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|1 month|ITT||Score||Standard Deviation|Mean
129588|NCT00556478|Secondary|Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3|Summary of mean IELT at Baseline and at month 3 during double-blind treatment|3 months|ITT||Seconds||Standard Deviation|Geometric Mean
129589|NCT00556478|Secondary|Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment|Percentage of subjects with mean IELT > 1 minute and >2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects|3 months|ITT||percentage of subjects|||Number
129590|NCT00556478|Primary|Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3|"To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by:~• changes in all 3 IPE domains from baseline to month 3~Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress"|Baseline to 3 Months|ITT||Score||Full Range|Mean
129591|NCT00556478|Primary|Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment|"To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:~• change in mean IELT from baseline to during the 3 month double-blind treatment~Results provide are ratio (over the 3 months/baseline)."|Baseline to 3 Months|ITT||ratio||Full Range|Geometric Mean
129592|NCT00556452|Primary|One-year Overall Survival Rate for AML|Percent Overall Survival (OS) for at one year for subjects with Acute Myeloid Leukemia (AML).|1 year|Patients with Acute Myeloid Leukemia (AML)||percent overall survival||95% Confidence Interval|Number
129593|NCT00556452|Secondary|Five-year Overall and Disease-free Survival of All Cases.||five years||||||
129594|NCT00556452|Secondary|Two-year Overall Survival for All Cases.|Percent Overall Survival (OS) at two years for all patients.|2 years|||percent overall survival||95% Confidence Interval|Number
129595|NCT00556452|Primary|Regimen Related Toxicities|The incidence of non-hematological toxicities (Common Terminology Criteria for Adverse Events (CTCAE) 3.0) from initiation of conditioning to Day + 30 or toxicities after day +30, possibly, probably or definitely related to conditioning for all patients treated with Clofarabine (independent of dose level).|two years|||toxicities|||Number
129596|NCT00556426|Secondary|Incidence of Filter Fracture|occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components)|at 6 months or at retrieval of the filter|adequate imaging was available to assess filter integrity in 83 of the 100 participants.||number of fractured filters|||Number
129597|NCT00556426|Secondary|Filter Migration > 2cm|Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more.|30 days post retrieval or 6 months following filter placement|Migration measurement made for 58 retrieved subjects, 22 non-retrieved subjects reaching the 6 month visit, and 2 non-retrieved subjects with attempted retrievals and imaging.||Percent Subjects with Filter Migration|||Number
129598|NCT00556426|Primary|Percentage of Participants With Adverse Events Through 30 Days Post Retrieval|Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure|30 days post retrieval|61 of 100 patients underwent filter retrieval during the study.||percentage of participants||95% Confidence Interval|Number
129599|NCT00556426|Primary|Clinical Success (Retrieval)|technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention.|Time of Retrieval or through 6 months of implantation|61/100 patients experienced filter retrieval during the study||participants|||Number
129600|NCT00556426|Primary|Technical Success (Retrieval)|Technical success for retrieval of the filter such that the entire filter is removed.|1 month post filter retrieval or through 6 months following implantation|61 of 100 patients enrolled underwent filter retrieval during the study.||participants|||Number
129605|NCT00556374|Secondary|Bone Metastases-free Survival|Bone metastasis-free survival (BMFS) determined by the time from randomization to the first observation of bone metastasis or death from any cause. BMFS will be analyzed after long-term follow-up is complete.|Participants will be followed for bone metastasis-free survival once every 12 months for 66 months after primary completion date.||10/2020||||
129606|NCT00556374|Secondary|Disease-free Survival|Disease-free survival (DFS) determined by the time from randomization to the first observation of disease recurrence or death from any cause. DFS will be analyzed after long-term follow-up is complete.|Participants will be followed for disease-free survival (DFS) once every 12 months for 66 months after primary completion date.||10/2020||||
129607|NCT00556374|Secondary|Number of Participants With New or Worsening Vertebral Fractures|Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height. A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures is defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.||participants|||Number
129608|NCT00556374|Secondary|Number of Participants With New Vertebral Fractures|"Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height.~A new vertebral fracture is defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays."|36 months|Vertebral Fracture Analysis Set with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36.||participants|||Number
129609|NCT00556374|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - femoral neck at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for femoral neck)||percent change||95% Confidence Interval|Least Squares Mean
129610|NCT00556374|Secondary|Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total hip at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total hip)||percent change||95% Confidence Interval|Least Squares Mean
129611|NCT00556374|Secondary|Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites|Bone mineral density was assessed by dual x-ray absorptiometry.|Baseline and Month 36|BMD analysis set - total lumbar spine at Month 36 (participants with evaluable BMD values at Baseline and Month 36 for total lumbar spine)||percent change||95% Confidence Interval|Least Squares Mean
129612|NCT00556374|Primary|Time to First Clinical Fracture|The time to first on-study clinical fracture defined as the number of days from randomization to the date of the x-ray confirming the clinical fracture. A clinical fracture is any clinically evident fracture with associated symptoms and confirmed by x-ray. Participants who died or withdrew without experiencing a clinical fracture were censored at the date of last contact or study termination whichever was earlier.|From randomization until the primary analysis cut-off date of 26 March 2014; maximum time on study was 87 months.|Full analysis set (all randomized participants)||days||95% Confidence Interval|Median
129613|NCT00556322|Secondary|Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129614|NCT00556322|Secondary|Time to Deterioration in the TOI|TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||weeks||95% Confidence Interval|Median
129615|NCT00556322|Secondary|Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)|TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants|||Number
129752|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10.|10 days|||participants|||Number
129616|NCT00556322|Secondary|Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L|Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129617|NCT00556322|Secondary|Time to Symptomatic Progression Using FACT-L|Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||weeks||95% Confidence Interval|Median
129618|NCT00556322|Secondary|Percentage of Participants With Symptomatic Progression Using FACT-L|Participants’ responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants|||Number
129619|NCT00556322|Secondary|Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Kaplan Meier estimates were used for analysis.|6 Months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
129620|NCT00556322|Secondary|Time to Deterioration in Quality of Life Using FACT-L|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||weeks||95% Confidence Interval|Median
129621|NCT00556322|Secondary|Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)|The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.||percentage of participants|||Number
129629|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population; n=number of EGFR positive or negative participants remaining at risk||percentage of participants||95% Confidence Interval|Number
129701|NCT00555672|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30.|Baseline up to Month 15|Efficacy; N=number of participants with objective response.||Months||Standard Deviation|Mean
129622|NCT00556322|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST|Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months|FAS population||percentage of participants||95% Confidence Interval|Number
129623|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. Tumor response was evaluated according to RECIST criteria (version 1.0). PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population; n=number of EGFR positive or negative participants who remained at risk||percentage of participants||95% Confidence Interval|Number
129624|NCT00556322|Secondary|PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only Participants with confirmed status of EGFR were included in the analysis; number of participants who were EGFR positive or negative||weeks||95% Confidence Interval|Median
129625|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative||percentage of participants|||Number
129626|NCT00556322|Secondary|Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Event free estimates were determined using Kaplan-Meier estimates.|6 Months|FAS population||percentage of participants||95% Confidence Interval|Number
129627|NCT00556322|Secondary|Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)|Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population||weeks||95% Confidence Interval|Median
129628|NCT00556322|Secondary|Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.0). Progressive Disease was defined as at least a 20 percent (%) increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The primary analysis of PFS used objective progression (RECIST) plus clinical progression (based on relevant clinical findings - if any). A further assessment of PFS was made on objective (radiological) progression. If clinical progression was diagnosed first, the participant was censored at the date of the last tumor assessment, where non-progression was documented.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months|FAS population||percentage of participants|||Number
129751|NCT00555438|Secondary|Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days|Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days.|at 1 month ± 5|||participants|||Number
129630|NCT00556322|Secondary|Duration of OS in EGFR Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative||months||95% Confidence Interval|Median
129631|NCT00556322|Secondary|Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative||percentage of participants|||Number
129632|NCT00556322|Primary|Probable Percentage of Participants Remaining Alive at 1 Year|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|1 Year|FAS population||percentage of participants||95% Confidence Interval|Number
129633|NCT00556322|Primary|Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)|OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months|FAS population||months||95% Confidence Interval|Median
129634|NCT00556322|Primary|Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)|Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.|Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months|FAS population||percentage of participants|||Number
129635|NCT00556166|Secondary|Number of Episodes of Abdominal Pain, Bloating, and Early Satiety|Data was not analyzed because PI left institution and terminated the study early.|1 year||||||
129636|NCT00556166|Primary|Number of Episodes of Nausea and Vomiting|Data was not analyzed because PI left institution and terminated the study early.|1 year||||||
129637|NCT00556140|Secondary|Depression and Psychosis Remission Rate|This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."||percent of participants|||Number
129638|NCT00556140|Primary|Depression and Psychosis Response Rate|This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.|Baseline and 7 weeks|"For the 3 participants who did not complete the study, the last observation carried forward technique was used to replace missing data for them."||percent of participants|||Number
129639|NCT00556075|Secondary|The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits||days|Zero participants were analyzed because no data were collected due to early termination|||||
129640|NCT00556075|Secondary|Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination|||||
129641|NCT00556075|Secondary|Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries||days|Zero participants were analyzed because no data were collected due to early termination|||||
129642|NCT00556075|Secondary|Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits||monthly|Zero participants were analyzed because no data were collected due to early termination|||||
129643|NCT00556075|Primary|Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination|||||
129644|NCT00556075|Primary|Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score||4 months|Zero participants were analyzed because no data were collected due to early termination|||||
129645|NCT00556049|Primary|To Determine the Overall Response Rate of Combination Therapy With Gemcitabine and Sunitinib in Sarcomatoid and/or Poor-risk mRCC Patients as First Line Therapy.||Until disease progression|||percentage of participants|||Number
129646|NCT00555997|Secondary|Change in 6-VAS-D Scores During Each Phase.||6 weeks|Forms not analyzable due to insufficient standardization across sites.|||||
129647|NCT00555997|Secondary|Responder/Non-responder|A responder during phase 1 or phase 2 is someone who demonstrated a 50% or greater decrease in HAMD-17 scores during phase 1 or phase 2 (corresponding).|6 weeks|||percentage of patients|||Number
129648|NCT00555997|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|Higher numbers represent more symptoms of a major depressive episode. Minimum is 0. Maximum is 52.|6 weeks|||points||Standard Deviation|Mean
129662|NCT00555906|Primary|Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1|RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.||milligram (mg)|||Number
129649|NCT00555906|Secondary|Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2|m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 “No pain” to 10 “Pain as bad as you can imagine”. The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.||units on a scale||95% Confidence Interval|Mean
129650|NCT00555906|Secondary|Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2|The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively.||units on a scale||95% Confidence Interval|Mean
129651|NCT00555906|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores for functional scales, global health status and symptom scales were calculated as an average of individual items, transformed to 0-100 scale; higher score=better level of functioning, health status or greater degree of symptoms. Score of the single items were transformed to 0-100 scale; higher score=greater degree of symptom/difficulty.|C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Patient Reported Outcomes (PRO) analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.||units on a scale||95% Confidence Interval|Mean
129652|NCT00555906|Secondary|Number of Participants With Laboratory Abnormalities: Phase 2|Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology [C reactive protein]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
129653|NCT00555906|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication until 28 days after the last dose of study medication that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study medication, which occurred during the trial. Treatment-related were adverse events (serious as well as non-serious adverse events) considered related to study medication by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|SAS included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
129654|NCT00555906|Secondary|Number of Participants With Adverse Events (AEs) by Severity: Phase 2|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|Safety analysis set (SAS) included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
129843|NCT00554996|Primary|Rate of UTI While Colonized With E. Coli 83972.|Rate of UTI during colonization with E. coli 83972.|0-266 days of colonization|Number of UTIs per 1000 patient-days during colonization with E. coli 83972.||UTIs per 1000 patient-days|||Number
129655|NCT00555906|Secondary|Overall Survival (OS): Phase 2|OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date [if death date unavailable] minus the date of first dose of study medication plus 1) divided by 30.44.|Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||months||95% Confidence Interval|Median
129656|NCT00555906|Secondary|Duration of Objective Response (DR): Phase 2|DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24hr urine M-protein. PR:>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr. PD: >=25% increase from lowest response level in serum M-component, urine M-component, >=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response.||months||95% Confidence Interval|Median
129657|NCT00555906|Secondary|Progression-free Survival (PFS): Phase 2|"PFS was the time from start of study treatment to date progressive disease was documented or death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder."|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||months||95% Confidence Interval|Median
129658|NCT00555906|Secondary|Time to Tumor Progression (TTP): Phase 2|TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per IMWGURC). PD: >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.|Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclib|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||months||95% Confidence Interval|Median
129659|NCT00555906|Secondary|Best Overall Response: Phase 1|Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, >=90% reduction in serum M-protein, <100 mg/24 hr urine M-protein. PR: >=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200mg/24 hr. Progressive disease (PD): >=25% increase from lowest response level in serum M-component or urine M-component, >=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met.|Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B)|RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.||participants|||Number
129660|NCT00555906|Secondary|Percent Change From Screening in Phosphorylated Retinoblastoma (Rb), Tumor Biomarkers and Soluble Biomarkers Levels: Phase 1||Screening, C1D1(baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)|Results are not reported because data was present as individual participant listings but not summarized for analysis, as per change in planned analysis.|||||
129661|NCT00555906|Primary|Percentage of Participants With Objective Response (OR): Phase 2|OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, <5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, >= 90% reduction in serum M-protein, <100 mg/24 hour (hr) urine M-protein. PR: >=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by >=90% or to <200 mg/24 hr, >=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, >= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was >=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable.|Cycle 1 Day 1 (baseline) up to end of study (up to cycle 22 for schedule B)|Primary response analysis set (PRAS) included first consecutive (by first treatment day) participants in response analysis set (RAS=included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable.||percentage of participants||95% Confidence Interval|Number
129663|NCT00555906|Primary|Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1|MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever >=38.5degrees Celsius (C); Grade >=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc >500 millisecond [msec]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count <25,000/mcL and/or ANC <500/mcL, or due to prolonged nonhematologic toxicities of Grade >=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity.|Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B|DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.||milligram (mg)|||Number
129664|NCT00555893|Secondary|Mean Influenza Well-being Score (Health, Ability to Perform Usual Activities and Sleep Quality)|Mean influenza wellbeing score will be calculated by first summing the daily scores for overall health (0-9 points), ability to perform usual activities (0-9 points), and sleep quality (0-9 points) from initial enrollment (randomization) up to (and including) the first day of symptom resolution. This will be divided by the number of reporting days to yield the mean daily influenza wellbeing score for each person.|Interval from randomization up to and including first day of symptom resolution (minimum 7 days, maximum 14 days)||||||
129665|NCT00555893|Secondary|Secondary Complications (New Clinical Diagnosis of Acute Otitis Media, Acute Sinusitis or Radiographically Confirmed Pneumonia)Documented in Medical Record, or Influenza-related Hospital Admission|Episodes of pneumonia will require a physician diagnosis of pneumonia, antimicrobial treatment for pneumonia, and an opacity or infiltrate on chest radiograph (or CT) that was not known to be chronic.|From 0 to 30 days after randomization||||||
129666|NCT00555893|Secondary|Duration of Viral Shedding||Interval (in days) from collection of the first sample yielding a positive influenza test to the last sample yielding a positive culture (maximum 14 days)||||||
129667|NCT00555893|Secondary|Mean Illness Severity Score|Mean severity score will be calculated by first summing the symptom severity scores for all reporting periods from initial enrollment (randomization) up to (and including) the first period of symptom resolution, as defined above. The summed total will be divided by the number of reporting periods to yield the mean severity score for each participant. For each reporting period, the possible symptom scores will range from 0 (all symptoms absent) to 24 (all symptoms severe). For children less than 2 years old, the possible scores will range from 0 to 15.|Calculated from initial enrollment (randomization) up to first period of symptom resolution (minimum of 7 days, maximum of 14 days)|All participants over 24 months of age (n=5 were excluded because <24 months)||mean severity score||Inter-Quartile Range|Median
129668|NCT00555893|Primary|Duration of Influenza Illness|Resolution is defined as occurring at the start of the first 24-hour period in which the total symptom score was less than or equal to 2 with no symptom rated higher than mild. Time to resolution was calculated from the time of randomization to symptom resolution in 12 hour increments.|Interval (in 12 hour blocks) from time of randomization until resolution (minimum 7 days, maximum 14 days)|||days||95% Confidence Interval|Median
129669|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Urinalysis at Discharge|For urinalysis, samples were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination): glucose, blood, protein, pH, specific gravity, leukocyte esterase, and microscopic examination. A shift in reference to normal was higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.||participants|||Number
129670|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing-Re-analysis With The Koch Procedure|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. The Koch procedure is a 3-step process to analyze results while utilizing the available information on magnitude of differences.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Deviation|Mean
129671|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Clinical Chemistry at Discharge|For biochemistry, blood samples (10.0mL) were taken at screening, admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: sodium, potassium, calcium, blood urea nitrogen (BUN)/Urea, creatinine, albumin, total protein and albumin/globulin (A/G) ratio, globulin, aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), total bilirubin, glucose, chloride, and creatine kinase. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.||participants|||Number
129672|NCT00555880|Secondary|Number of Participants With Shifts in Reference to Normal Range For Hematology Analytes at Discharge|For hematology, blood samples (5.0mL) were taken at screening, study admission (if greater than 14 days since screening) and discharge/early termination. The following parameters were assessed: hemoglobin, hematocrit, red blood cells (RBC), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell count – total and differential (WBC), and platelet count. A shift in reference to normal was either lower or higher at discharge.|Baseline to discharge|The Safety population, defined as all subjects who received at least one dose of investigational product.||participants|||Number
130105|NCT00552240|Secondary|Proportion of Patients Reporting CNS Side Effects of Any Severity||baseline to week 52|All treated patients||participants|||Number
129673|NCT00555880|Secondary|Heart Rate at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Heart rate was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||beats per minute||Standard Deviation|Mean
129674|NCT00555880|Secondary|Diastolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||mmHg||Standard Deviation|Mean
129675|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 1 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The FAS, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Error|Least Squares Mean
129676|NCT00555880|Secondary|Systolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2|Blood pressure was recorded just before tilt table testing, at each minute during tilt table testing, and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||mmHg||Standard Deviation|Mean
129677|NCT00555880|Secondary|Final Blood Pressure During Tilt Table Testing|Blood pressure was recorded just before tilt table testing and immediately after. Timed readings were stopped once a subject experienced near-syncopal symptoms, except for subjects for whom the table was returned to horizontal before 1 minute; for these subjects, a reading was made at 1 minute and was included in analyses. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||mmHg||Standard Deviation|Mean
129678|NCT00555880|Secondary|Number of Participants With Improvement of Patient CGI-I Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject's orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The patient completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||participants|||Number
129679|NCT00555880|Secondary|Number of Participants With Improvement of Clinician Clinician's Global Impression- Improvement (CGI-I) Scores After Tilt Table Test|"The CGI-I instrument assesses the overall impression of the subject’s orthostatic hypotension during the tilt table test by using a 7-point scale, with 1 being Very much improved; 2, Much improved; 3, Slightly improved; 4, No change; 5, Slightly worse; 6, Much worse; and 7, Very much worse. The clinician completed the CGI-I after each of the tilt table tests. A patient was assessed as Improved if the score was 1, 2, or 3. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out."|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||participants|||Number
129680|NCT00555880|Secondary|Scores for 6 Items of The OHSA|"The OHSA measures the severity of six symptoms/symptom complexes associated with OH: dizziness, lightheadedness, and feeling faint; problems with vision; weakness; fatigue; trouble concentrating; and head/neck discomfort. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from none to worst possible. Scores for each subscale range from 0 (no symptoms) to 10 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, and feeling faint."|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||scores on a scale||Standard Deviation|Mean
129681|NCT00555880|Secondary|Total Score of the Orthostatic Hypotension Symptom Assessment (OHSA)|The OHSA measures the severity of six symptoms/symptom complexes associated with orthostatic hypotension. Subjects rated symptoms experienced during the tilt table test on an eleven-point scale from “none” to “worst possible”. The OHSA total score is the sum of six subscales, ranging from 0 (no symptoms) to 60 (worst possible symptoms). The OHSA was completed after the tilt table test was over, but was answered with reference to symptoms experienced during testing. The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|Approximately 1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||scores on a scale||Standard Error|Least Squares Mean
129682|NCT00555880|Secondary|Duration of The Effect of Treatment at 3 Hours Post-dose|Duration of effect was defined as the difference in time to onset of near-syncopal symptoms between the first and second tilt table test, conducted at 1 hour and 3 hours post-dose, respectively, at Treatment Visit 2 (time to onset at 3 hours minus time at 1 hour). The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 and 3 hours post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Deviation|Mean
129683|NCT00555880|Secondary|Time to Near-syncopal Symptoms at Treatment Visit 1|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set, defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Error|Least Squares Mean
129684|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population Analysis #2|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near- syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out. In this outcome measure, the data analyzed are the same as for Outcome Measure 4 but the summary data are presented as least squares mean (standard error).|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.||seconds||Standard Error|Least Squares Mean
129685|NCT00555880|Secondary|Time to Onset of Near-syncopal Symptoms in The Per-protocol Population|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Per-protocol set, defined as participants in the Full Analysis Set who completed the study and were protocol compliant.||seconds||Standard Deviation|Mean
129686|NCT00555880|Primary|Time to Onset of Near-syncopal Symptoms During Tilt Table Testing|The tilt table test is a 10-minute assessment performed using a manual or automated tilt table in a specialized laboratory. Subjects were moved onto the horizontal table and secured to the table with straps to prevent injury. After an equilibration period of at least 10 minutes with the subject at rest, the test began and the head of the tilt table was elevated to a 70-degree angle over a period of up to 30 seconds. The head-up tilt table test in this study was conducted 1 hour after administration of the study medication. The endpoint was a confirmed report of a near-syncopal symptom(s) (of sufficient severity that caused the patient to ask that the tilt table be returned to the horizontal position). Symptoms of near syncope were defined as dizziness, lightheadedness, feeling faint, or feeling like the subject might black out.|1 hour post-dose|The Full Analysis Set (FAS), defined as subjects who were randomized, received at least one dose of study drug, and had at least one measurement of time to syncope during tilt table testing.||seconds||Standard Deviation|Mean
129687|NCT00555750|Secondary|Change in Total Sleep Time Measured by PSG|Change (baseline minus post-treatment) in total sleep time measured by polysomnography after two months treatment with 3mg eszopiclone or placebo|baseline and 2 months post-treatment|||minutes||Standard Deviation|Mean
129688|NCT00555750|Secondary|Change in Total Sleep Time as Reported in Sleep Diaries|Total sleep time reported on sleep diaries prior to treatment with 3mg eszopiclone or placebo. Change defined as baseline minus post-treatment).|baseline and 2 months post-treatment|||hours||Standard Deviation|Mean
129689|NCT00555750|Secondary|Change in Mean Lapses of Attention|At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery every three hours during wake periods. The battery included the Psychomotor Vigilance Task (PVT). The PVT involved a 10-minute visual reaction time (RT) performance test in which the subject was instructed to maintain the fastest possible RT to a simple visual stimulus. Lapses of attention refer to the number of times the subject failed to respond to the signal within 500ms. Mean lapses per test across 6 tests given a 4 hour intervals during normal waking hours (and not during the IVGTT) during the 30-hr were compared for the post-treatment visit as the absolute deviation from the baseline mean lapses/test.|baseline and 2 months post-treatment|||lapses of attention||Standard Error|Mean
129690|NCT00555750|Secondary|Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)|"At visits before and after two months treatment with 3mg eszopiclone or placebo, subjects completed a short test battery including the Karolinska Sleepiness Scale (KSS) every three hours during wake periods. KSS is a single-item scale of sleepiness on a scale from 1 (very alert) to 9 (very sleepy, fighting sleep, an effort to keep awake). Subjective sleepiness was defined as mean deviation from baseline KSS."|baseline and 2 months post-treatment|||units on a scale||Standard Error|Mean
129691|NCT00555750|Secondary|Post-treatment Ghrelin Levels|Ghrelin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|2 months post-treatment|||ng/mL||Standard Deviation|Mean
129692|NCT00555750|Secondary|Pre-treatment Ghrelin Levels|Ghrelin levels prior to two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|baseline|||ng/mL||Standard Deviation|Mean
129693|NCT00555750|Secondary|Post-treatment Leptin Levels|Leptin levels following two months treatment with 3mg eszopiclone or placebo, measured after an overnight fast|two months post-treatment|||ng/mL||Standard Deviation|Mean
129694|NCT00555750|Secondary|Pre-Treatment Leptin Levels|Leptin Levels prior to two months treatment with eszopiclone or placebo, measure after an overnight fast|baseline|||ng/mL||Standard Deviation|Mean
129695|NCT00555750|Secondary|Change in HbA1c Levels|Difference in HbA1c levels following two months treatment with eszopiclone versus placebo|baseline and 2 months post-treatment|||percentage of glycosylation||Standard Error|Mean
129696|NCT00555750|Secondary|Change in Glucose Effectiveness (SG)|"Glucose effectiveness was defined as the ability of glucose itself to enhance its own disappearance independent of an increment in insulin. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].~SG calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment|||min^-1||Standard Deviation|Mean
129697|NCT00555750|Secondary|Change in Insulin Sensitivity (SI)|"Insulin sensitivity index (SI) was defined in quantitative terms as the effect of insulin to catalyse the disappearance of glucose from plasma. [R. Bergman, Horm Res 2005;64(suppl 3):8-15].~SI calculated using Bergman's Minimal model analyses (Minmod Millennium 2000; R. Bergman, University of South- ern California, Los Angeles, CA)"|baseline and 2 months post-treatment|||mU/l)^-1*min^-1||Standard Deviation|Mean
129698|NCT00555750|Secondary|Acute Insulin Response to Glucose (AIRg)|Change over two months in 1st phase Insulin secretion|baseline and 2 months post-treatment|||mU*l^-1*min||Standard Deviation|Mean
129699|NCT00555750|Primary|Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test|Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.|baseline and 2 months post-treatment|||%/min, slope of natural log glucose||Standard Deviation|Mean
129700|NCT00555672|Secondary|Progression-Free Survival (PFS)|Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30.|Baseline up to Month 15|Efficacy||Months||95% Confidence Interval|Median
129702|NCT00555672|Secondary|Number of Participants With Objective Response|Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 Months|Efficacy: all participants enrolled in the study who received at least 1 dose of study medication. N=number of participants with measurable disease at baseline.||Participants|||Number
129703|NCT00555672|Secondary|Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU|Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||ng*h/mL||Standard Deviation|Mean
129704|NCT00555672|Secondary|Clearance (CLss) of 5-FU|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=the number of participants contributing to the summary statistics. CLss calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||Liters per hour||Standard Deviation|Mean
129705|NCT00555672|Secondary|Infusion Rate (Zero Order) (R0) of 5-FU|Infusion rate of 5-FU equals total dose divided by infusion time.|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N= number of participants contributing to the summary statistics. R0 calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||mg/hr||Standard Deviation|Mean
129706|NCT00555672|Secondary|Steady State Concentration (Css) of 5-Fluorouracil (5-FU)|Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).|Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)|PK; N=number of participants contributing to the summary statistics. Css calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||ng/mL||Standard Deviation|Mean
129707|NCT00555672|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|PK; N=the number of participants contributing to the summary statistics. Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the MTD (25 mg Sunitinib).||hours||Full Range|Median
129708|NCT00555672|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]|Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).|Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)|PK; N=the number of participants contributing to the summary statistics. AUC(0-24) of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at the maximum tolerated dose (MTD; 25 mg Sunitinib).||ng*h/mL||Standard Deviation|Mean
129709|NCT00555672|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)|Pharmacokinetic (PK): participants who received Sunitinib and had sufficient plasma concentration data for calculation of PK parameters; N=number of participants contributing to summary statistics. Cmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) calculated for at least 6 individual participants treated at maximum tolerated dose.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
129710|NCT00555672|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|The incidence of DLTs assessed during the first cycle (21 days).|Cycle 1 (Baseline to Day 21)|Safety: enrolled participants who received at least 1 dose of study drug.||Participants|||Number
129711|NCT00555620|Secondary|Progression-Free Survival (PFS)|PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis subset of population of participants who had an event||months||95% Confidence Interval|Median
129712|NCT00555620|Secondary|Duration of Response (DR)|DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.|Baseline up to Month 15|Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 reporting group analyzed; all had stable disease during specified time frame||months||Full Range|Median
129713|NCT00555620|Secondary|Percentage of Participants With Objective Response|Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Day 21 of every even-numbered cycle up to 15 months|Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).||percentage of participants||95% Confidence Interval|Number
129714|NCT00555620|Secondary|AUClast for 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
129715|NCT00555620|Secondary|AUClast for 5'DFUR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
129716|NCT00555620|Secondary|AUClast for 5'DFCR|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
129717|NCT00555620|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
129718|NCT00555620|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)|Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
129719|NCT00555620|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category||ng*hr/mL||Standard Deviation|Mean
129720|NCT00555620|Secondary|Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
129721|NCT00555620|Secondary|t1/2 for 5-FU|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
129722|NCT00555620|Secondary|t1/2 for 5'DFUR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
129723|NCT00555620|Secondary|t1/2 for 5'DFCR|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
129724|NCT00555620|Secondary|t1/2 for CAP|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; Number of participants analyzed (N): participants with evaluable data||hr||Standard Deviation|Mean
129725|NCT00555620|Secondary|Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.|||||
129726|NCT00555620|Secondary|Tmax for 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
129727|NCT00555620|Secondary|Tmax for 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
129728|NCT00555620|Secondary|Tmax for 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
129729|NCT00555620|Secondary|Tmax for CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hr||Full Range|Median
129730|NCT00555620|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||hour (hr)||Full Range|Median
129731|NCT00555620|Secondary|Cmin of 5-FU||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129732|NCT00555620|Secondary|Cmin of 5'DFUR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129733|NCT00555620|Secondary|Cmin of 5'DFCR||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129734|NCT00555620|Secondary|Cmin of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
130106|NCT00552240|Secondary|Incidence of Patients With AIDS Progression at Each Visit|Cumulative incidence of patients with AIDS progression are shown|baseline to week 52|Full Analysis set||participants|||Number
129735|NCT00555620|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129736|NCT00555620|Secondary|Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129737|NCT00555620|Secondary|Cmax of 5’-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129738|NCT00555620|Secondary|Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129739|NCT00555620|Secondary|Cmax of CAP||Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)|PK analysis set population; number of participants analyzed (N): participants with evaluable data||ng/mL||Standard Deviation|Mean
129740|NCT00555620|Secondary|Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)||Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)|Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
129741|NCT00555620|Primary|Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)|Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21|DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.||participants|||Number
129742|NCT00555568|Primary|Overall Mental Health (BASIS-24 Summary Score)|BASIS-24 refers to the 24-item Behavior and Symptom Identification Scale. Responses range from 0-4; scores range from 0-4; higher values indicate greater symptom severity.|3 months|||units on a scale||Standard Deviation|Mean
129743|NCT00555568|Primary|VR-12 MCS|VR-12 MCS refers to the Mental Health Component of the SF-12. The rating scale varies depending on the item. Scores range from 0-100; higher values indicate better mental health;|3 months|||units on a scale||Standard Deviation|Mean
129744|NCT00555568|Primary|Social Support|Social Support was assessed by the Medical Outcomes Study Social Support Survey. Response options range from 1-5 and scores range from 19-95. Higher scores indicate greater social support|3 months|||units on a scale||Standard Deviation|Mean
129745|NCT00555568|Primary|Empowerment|Empowerment is measured by the “Making Decisions” instrument. Response options range from 1-4 and scores can range from 28-112. Higher scores indicate more empowerment.|3 months|||units on a scale||Standard Deviation|Mean
129746|NCT00555568|Primary|Patient Activation|"Patient activation refers to patient knowledge skill and confidence for self-management.~Full name of the scale is Patient Activation Measure (PAM). Scale response options range from 1-4 and scores can range from 13-52. Higher values indicate greater activation. No subscales are used."|3 months|||units on a scale||Standard Deviation|Mean
129747|NCT00555477|Primary|The Number of Women Who Recover Ovarian Function Within 12 Months of Al Monotherapy|In part 1 ovarian function recurrence is defined as one estradiol value >20 pg/ml or two consecutive values >10 pg/ml. In part 2 ovarian function recurrence is defined as a >75% increase in estradiol levels over prior if prior value was 15-30 pg/ml, or one estradiol value >30 pg/ml, or three consecutive values >20 pg/ml.|12 months|||participants|||Number
129748|NCT00555464|Secondary|Toxicity to Medications|"Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period.~Please see Adverse Events module for more details."|Initial visit, 2, 4, 6, 10 and 12 weeks of therapy|||participants|||Number
129749|NCT00555464|Primary|Response of Hemangioma (IH) to Treatment|"Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: >40% increase in volume by MRI, Partial response: >65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or <40% increase or <65% decrease in volume by MRI.~Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: >30% increase in IH size, Partial response: >30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above.~Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume."|6 weeks|Per protocol, all participants were analyzed, no matter the treatment arm or treatment success.||participants|||Number
129750|NCT00555438|Secondary|Death at 1 Month ± 5 Days|Evaluate the total number of death at 1 month ± 5 days|1 month ± 5 days|||participants|||Number
130132|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment|Results within time windows, patients on-treatment|baseline to week 6|All treated patients||Participants|||Number
129753|NCT00555438|Secondary|Number of Patients With Major Bleedings at 1 Month ± 5 Days.|evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days.|45 day|||participants|||Number
129754|NCT00555438|Primary|Number of Patients With Major Bleedings Between Day 1 and Day 10.|evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L.|10 day|||participants|||Number
129755|NCT00555425|Secondary|Health Status|Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|18 weeks|Results are provided on those individuals who completed this assessment||units on a scale||Standard Deviation|Mean
129756|NCT00555425|Secondary|Patient Satisfaction|Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.|18 weeks|Results are provided on those individuals who completed this assessment||units on a scale||95% Confidence Interval|Mean
129757|NCT00555425|Secondary|Changes in HIV Risk|"As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse).~There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales.~Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status."|Baseline and 18 weeks|Overall numbers of participants analyzed that were original entered (56 Taper Condition, 57 Maintenance Condition) were inadvertently entered incorrectly. Correct numbers of participants analyzed are 57 Taper Condition, 56 Maintenance Condition.||units on a scale||Standard Deviation|Mean
129758|NCT00555425|Secondary|Reduction in Cocaine Use|As measured by the percent of provided urines positive for cocaine|18 weeks|Overall numbers of participants analyzed that were original entered (56 Taper Condition, 57 Maintenance Condition) were inadvertently entered incorrectly. Correct numbers of participants analyzed are 57 Taper Condition, 56 Maintenance Condition.||percent of cocaine positive urines||Standard Deviation|Mean
129759|NCT00555425|Secondary|Retention in Treatment|Mean number of days from randomization to last clinical contact|18 weeks|||number of days||95% Confidence Interval|Mean
129760|NCT00555425|Secondary|Proportion of Patients Protectively Transferred|>= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study|18 weeks|||participants|||Number
129761|NCT00555425|Primary|Illicit Opioid Use|Urinalysis based on scheduled weekly urine screenings during treatment period|18 weeks|Overall numbers of participants analyzed that were original entered (56 Taper Condition, 57 Maintenance Condition) were inadvertently entered incorrectly. Correct numbers of participants analyzed are 57 Taper Condition, 56 Maintenance Condition.||percent of opioid negative urine samples||95% Confidence Interval|Mean
129762|NCT00555360|Secondary|Adherent to Heart Failure Medication|Percent of patients with perfect Heart Failure medication adherence over the prior month as measured by the four Heart Failure Self-Care Behavior items focused on adherence.|twelve-month follow-up|||percentage of participants/perfect adher|||Number
129763|NCT00555360|Secondary|Revised Heart Failure Self-Care Behavior Scale (HFSCB)|Higher scores indicate better Heart Failure self-care. The HFSCB contains 29 items with answer choices ranging from 0 to 5. The total score ranges from 0 to145.|twelve-month follow-up|||units on a scale||Standard Deviation|Mean
129764|NCT00555360|Primary|Heart Failure-specific Quality of Life|Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.|twelve-month followup|||units on a scale||Standard Deviation|Mean
129765|NCT00555321|Secondary|Change in Protein to Creatinine Ratio From Month 3 to Month 12.||Month 3 and 12|Protein creatinine ratio change was not analyzed|||||
129766|NCT00555321|Secondary|Number of Participants Who Had Abnormalities in Electrocardiograms: 12-month Treatment Phase||Baseline (pretransplant), Week 52|ECG data was not analyzed.|||||
129767|NCT00555321|Secondary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities: 12-month Treatment Phase|Low total calcium: <7 mg/dL; High total calcium: >12.5 mg/dL ; Low bicarbonate: <11 mEq/L; Low serum potassium: <3.0 mEq/L; High serum potassium:>6.0 mEq/L; High serum magnesium: >2.46 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; Low albumin: <2 g/dL; High uric acid: >10 mg/dL|Baseline (pretransplant), Weeks 4, 12, 24, and 52|ITT population, all randomized and transplanted participants. n= participants with all observations.||participants|||Number
129768|NCT00555321|Secondary|Number of Participants With Marked Liver and Kidney Function Abnormalities: 12-month Treatment Phase|ULN= upper limit of normal; Normal ranges are provided by the central laboratory and may vary according to sex and age. High alkaline phosphatase (ALP): >5.0*ULN U/L; High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0 * ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Baseline (pretransplant), 4, 12, 24, 52 weeks|ITT population, all randomized and transplanted participants. n= participants with all observations.||participants|||Number
130133|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment|Results within time windows, patients on-treatment|baseline to week 4|All treated patients||Participants|||Number
129769|NCT00555321|Secondary|Number of Participants With Marked Hematology Abnormalities: 12-month Treatment Phase|Low hemoglobin: <8 g/dL; Low platelet count: <50*10^9 C/L; Low leukocytes: <2.0 *10^3 c/µL; Low lymphocytes (absolute): <0.5*10^3 c/µL; Low neutrophils (absolute): <1.0*10^3 Cc/µL.|Baseline (pretransplant), 2, 4, 8, 12 weeks, and every 4 weeks for week 16 to 52|ITT population, all randomized and transplanted participants. n= participants with all observations.||participants|||Number
129770|NCT00555321|Secondary|Number of Participants Who Had Adverse Events of Special Interest During 12-month Treatment Phase|AE of of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial), serious infections|Day 1 (randomization) to 12 months or ≤ 56 days after discontinuation of study medication|ITT population, all randomized and transplanted participants.||participants|||Number
129771|NCT00555321|Secondary|Number of Participants Who Had AEs, Death, SAEs or Were Discontinued Due to AEs: 12-month Treatment Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Day 1 (randomization) to 12 m + 8 week follow-up or ≤ 56 days after discontinuation of study medication|ITT population: all randomized and transplanted participants||participants|||Number
129772|NCT00555321|Secondary|Glycosylated Hemoglobin (HbA1C) Values: 12-month Treatment Phase|The HbA1c test is important in diabetes as a long-term measure of control over blood glucose, where the glucose bound to hemoglobin during the past 3-4 months is measured. A baseline diabetes participant was one who had a medical history of diabetes or being under anti-diabetic medication at the time of the transplantation. BL = baseline, DM = Diabetes mellitus.|6, 12 months (mth) posttransplant|ITT population, all randomized and transplanted participants. n = Participants with both baseline and postbaseline values.||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
129773|NCT00555321|Secondary|Percentage of Participants With New Onset Diabetes Mellitus (NODM): 12-month Treatment Phase|A participant who did not have diabetes prior to randomization was determined to have NODM if(i) the participant received an antidiabetic medication for a duration of at least 30 days or(ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is>=126 mg/dL (7.0 mmol/L). For 95% CI within each group, normal approximation is used if N>=5. For 95% CI of difference, adjustment is made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm.|6 and 12 months posttransplant|ITT population, all randomized participants without Diabetes Mellitus (pre-transplantation).||percentage of participants||95% Confidence Interval|Number
129774|NCT00555321|Secondary|Number of Participants Who Received Anti-hypertensive Therapy at Month 12||12 months posttransplant|ITT population, all randomized and transplanted participants.||participants|||Number
129775|NCT00555321|Primary|Number of Participants With Marked Electrolytes, Protein and Metabolic Test Abnormalities During the LTE|Low Serum Potassium: <3.0 meq/L; High serum potassium:>6.0 mEq/L; Low serum magnesium:<0.8 mEq/L; Low serum sodium: <130 mEq/L; High serum sodium: >155 mEq/L; Low inorganic phosphorus: <2.0 mg/dL; High uric acid: >10 mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.||participants|||Number
129776|NCT00555321|Primary|Number of Participants With Marked Liver and Kidney Function Abnormalities During the LTE|ULN= upper limit of normal; Normal ranges are provided by the Central Laboratory and may vary according to sex and age. High alanine aminotransferase (ALT): >5.0*ULN U/L; High aspartate aminotransferase (AST): >5.0*ULN U/L; High direct bilirubin: >3.0*ULN mg/dL; High g-glutamyl transferase (GGT): >5.0*ULN U/L; High total bilirubin: >3.0*ULN mg/dL; High creatinine: > 3.0*ULN mg/dL|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.||participants|||Number
129777|NCT00555321|Primary|Number of Participants With Marked Hematology Abnormalities During the LTE|Low platelet count: <50*10^9 c/µl; Low leukocytes: <2.0*10^3 c/µl; Low lymphocytes (absolute): <0.5*10^3 c/µl; Low neutrophils (absolute): <1.0*10^3 c/µl.|Every 4 weeks from Week 53 to Week 104.|ITT-LTE population: All randomized and transplanted participants who entered long-term extension. n= participants who had a laboratory test reading after transplant for the specific analyte.||participants|||Number
129778|NCT00555321|Primary|Number of Participants Who Had AEs of Special Interest During the LTE|AE of special interest included malignancies (including skin carcinomas), infections (viral, cytomegalovirus, herpes, fungal, and bacterial).|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension||participants|||Number
129779|NCT00555321|Primary|Number of Participants Who Had Adverse Events (AEs), Death, Serious AEs (SAEs) or Were Discontinued Due to AEs (Includes Long Term Extension [LTE] Data)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Day 1 (randomization) to Week 104 + within 56 Days after the last infusion/dose, Deaths were monitored up to database lock (20-June-2011)|ITT-LTE population, (all randomized and transplanted participants who entered long term extension). Participants were grouped according to the treatment to which they were randomized initially.||participants|||Number
129780|NCT00555321|Secondary|Percentage of Participants Who Have Hypertension at Any Given Time During the 12-month Treatment Phase|Percentage of participants at any given time who meet the definition of hypertension. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
131491|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Participants|||Number
129781|NCT00555321|Secondary|Percentage of Participants Who Developed Hypertension in 12-month Treatment Phase|Percentage of participants who develop hypertension after randomization and transplantation. Transient post-operative increases in BP were not to be counted as new onset hypertension. Hypertension was to be assessed only at or after the Week 4 visit. Participants were considered to have hypertension when either of the following criteria were met: (1) SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg or (2) participant received an antihypertensive medication(s) for the indication of hypertension or due to medical history of hypertension.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
129782|NCT00555321|Secondary|Summary Statistics for Mean Arterial Pressure: 12-month Treatment Phase||BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mm Hg||Standard Deviation|Mean
129783|NCT00555321|Secondary|Summary Statistics for Diastolic Blood Pressure: 12-month Treatment Phase|Participants were considered to have hypertension if they had Diastolic Blood Pressure (SBP) ≥ 80 mmHg.|BL (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mm Hg||Standard Deviation|Mean
129784|NCT00555321|Secondary|Summary Statistics for Systolic Blood Pressure: 12-month Treatment Phase||Baseline (pretransplant), 1, 3, 6, 9, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mm Hg||Standard Deviation|Mean
129785|NCT00555321|Secondary|Summary Statistics for Lipid Parameters - Serum Triglyceride: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
129786|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants.||mg/dL||Standard Deviation|Mean
129787|NCT00555321|Secondary|Summary Statistics for Lipid Parameters- Serum Low Density Lipoprotein Cholesterol (LDL): 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
129788|NCT00555321|Secondary|Summary Statistics for Lipid Parameters; Serum HDL Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
129789|NCT00555321|Secondary|Summary Statistics for Lipid Parameters-Serum Total Non-High Density Lipoprotein (Non-HDL) Cholesterol: 12-month Treatment Phase||Baseline (pretransplant), 1, 6, 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
129790|NCT00555321|Secondary|Percentage of Participants Meeting the Definition of Dyslipidemia, Hypertriglyceridemia or Hypercholesterolemia at Any Given Time: 12-month Treatment Phase|Percentage of participants at any given time (at Month 6 and Month 12) who met the definition of dyslipidemia.Dyslipidemia is defined as hypertriglyceridemia (TGs ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (LDL ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
129791|NCT00555321|Secondary|Percentage of Participants Who Develop Dyslipidemia, Hypertriglyceridemia and Hypercholesterolemia After Randomization and Transplantation: 12-month Treatment Phase|Percentage of participants who develop dyslipidemia, defined as hypertriglyceridemia (triglycerides [TGs] ≥ 500 mg/dL [5.65 mmol/L]), hypercholesterolemia (Low density lipoprotein [LDL] ≥ 100 mg/dL [2.59 mmol/L]), or elevated non-high density lipoprotein (non- high density lipoprotein [HDL] ≥ 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs ≥ 200 mg/dL [2.26 mmol/L]).|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants who did not have dyslipidemia at baseline||percentage of participants||95% Confidence Interval|Number
129792|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV RNA Levels >2.4 * 10^6 U/mL and >4.7 * 10^6 U/mL During the LTE|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 x 10^6 U/mL and > 4.7 x 10^6 U/mL were descriptively summarized by treatment group. BL = baseline|BL (pretransplant), 12, 18, 24, 30 months (mo) posttransplant|ITT-LTE population, all randomized and transplanted participants. n= participants with HCV RNA values.||participants|||Number
129793|NCT00555321|Secondary|Number of Participants (Who Were HCV Positive at Baseline) With HCV Ribonucleic Acid (RNA) Levels >2.4*10^6 U/mL and >4.7*10^6 U/mL: 12-month Treatment Phase|Recurrent hepatitis C infection of the allograft following liver transplantation can be detected by monitoring HCV RNA levels. In HCV positive participants, quantitative HCV RNA levels > 2.4 * 10^6 U/mL and > 4.7 * 10^6 U/mL were descriptively summarized by treatment group. BL=baseline|Baseline (pretransplant), 6 and 12 months (mo) posttransplant|ITT population, all randomized and transplanted participants. n= participants who were HCV positive at baseline.||participants|||Number
129794|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) During the LTE|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|12 months posttransplant, end of study (database lock, 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension.||percentage of participants||95% Confidence Interval|Number
130134|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment|Results within time windows, patients on-treatment|baseline to week 2|All treated patients||Participants|||Number
129795|NCT00555321|Secondary|Percentage of Participants (Who Were Hepatitis C Virus [HCV] Positive at Baseline) With HCV Recurrence (Assessed by Central Pathologist) by 12 Months|HCV Recurrence is defined as Histological confirmation on liver biopsy by the Ishak (modified Knodell) system and required both a score >= 5 out of 18 on modified Histological Activity Index grading and a fibrosis Score >= 2 out of 6 on modified staging. All biopsies, including Week 52 biopsies, were considered. Only the first HCV recurrence episode for each participant was counted. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used. For 95% CI of difference, normal approximation was used if N>=5 in both arms, otherwise exact method was used.|6 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
129796|NCT00555321|Secondary|Belatacept Trough Concentration Before Each Infusion During the LTE|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected predose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105, 532, 728.|All randomized participants who received Belatacept, and had complete PK profile. n= participants with values at all time points.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
129797|NCT00555321|Secondary|Belatacept PK Parameter: Clearance From Ascites Fluid|Clearance from ascites fluid was determined by amount excreted in ascites fluid (Ae, asc)[0-T] / AUC[0-T], where 0-T is the same duration relative to a belatacept infusion.|Days 1 to 14|Serum AUC was not available for the time interval corresponding to ascites fluid collection.|||||
129798|NCT00555321|Secondary|Belatacept PK Parameter: Amount Excreted in Ascites Fluid Over Days 1 to 14|Amount Excreted in Ascites (Ae,asc) was estimated from the ascites drug concentrations and volumes within a dosing interval.|Days 1 to 14|All randomized participants who received belatacept, and had complete PK profile.||µg||Standard Deviation|Mean
129799|NCT00555321|Secondary|Belatacept PK Parameter: Volume of Distribution|Volume of distribution (Vss) is the volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration. . Vss was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||L/kg||Standard Deviation|Mean
129800|NCT00555321|Secondary|Belatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism. CLT was estimated from AUC (TAU) between Weeks 12 and 16, assuming steady state.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
129801|NCT00555321|Secondary|Belatacept PK Parameter: Terminal Half-life|Terminal Half-life (T 1/2) is the time a drug takes for the concentration levels to fall to 50% of their value.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||hour||Standard Deviation|Mean
129802|NCT00555321|Secondary|Belatacept PK Parameter: Minimum Plasma Concentration|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
129803|NCT00555321|Secondary|Belatacept PK Parameter: Area Under the Serum Concentration-time Curve to the End of the Dosing Period (AUCtau)|Area under the plasma concentration-time curve for each dosing interval is determined using the linear trapezoidal rule. The AUC(TAU) of belatacept from the MI regimens and LI regimens were calculated over 2 and 4 weeks respectively.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
129804|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Time to Achieve the Maximum Plasma Concentration|Maximum Plasma Concentration (Tmax) is the time taken to reach the maximum observed plasma concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||hour||Full Range|Median
129805|NCT00555321|Secondary|Belatacept Pharmacokinetic (PK) Parameter: Maximum Serum Concentration|Maximum Plasma Concentration (Cmax) is the maximum observed serum drug concentration.|Samples were collected at Pre dose on Days 5, 14, 28, 56, 84, 112, 168, 252, 336, 364; after end of infusion on Days 1, 5, 84, 112, 196, 336; and on Days 9, 85, 91, 98, 105.|All randomized participants who received belatacept, and had complete PK profile.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
129806|NCT00555321|Secondary|Mean Change in Baseline Values of Cystatin C at 2 and 12 Months|Cystatin C is a protein encoded by the CST3 gene, which is mainly used as a biomarker of kidney function. If kidney function and glomerular filtration rate decline, the blood levels of cystatin C rise.|Baseline (pretransplant), 2, and 12 months posttransplant|ITT population: all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mg/L||Standard Deviation|Mean
129807|NCT00555321|Secondary|Mean Change From Baseline Serum Creatinine at Months 1, 2, 3, 6 and 12|Measurement of SCr is commonly used as an indicator of renal function. High creatinine blood level is an indicator of deficient filtering by the kidney. SCr was determined at baseline and various post-baseline time points.|Baseline (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n= participants who have both baseline and postbaseline values.||mg/dL||Standard Deviation|Mean
129959|NCT00553501|Primary|Number of Participants With Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.~CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions"|12 months|||participants|||Number
129808|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR During the LTE|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline (pretransplant time point), 1, 2, 3, 6,12, 18, 24, 30, 36 months posttransplant|ITT-LTE population, all randomized and transplanted participants who entered long term extension. n= participants who have both baseline and postbaseline values.||mL/min/1.73 m^2||Standard Deviation|Mean
129809|NCT00555321|Secondary|Mean Change From Baseline in Calculated GFR, by Modification of Diet in Renal Disease (MDRD) Equation: 12-month Treatment Phase|GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine (ScR), age, race, gender, blood urea nitrogen (BUN), and albumin (Alb). GFR (mL/min/1.73 m^2) = 170*(Scr)^-0.999*(Age)^-0.176*(0.762 if female)*(1.180 if African American)*(BUN)^-0.170*(Alb)^+0.318. ). BL= baseline, mL= milliliters; min= minute; m^2= meters squared.|Baseline [BL] (pretransplant time point), 1, 2, 3, 6 and 12 months posttransplant|ITT population, all randomized and transplanted participants. n = participants who had both baseline and postbaseline values.||mL/min/1.73 m^2||Standard Deviation|Mean
129810|NCT00555321|Secondary|Mean Change From Baseline in Measured Glomerular Filtration Rate (GFR): 12-month Treatment Phase|GFR was assessed using a true measure of glomerular filtration via iothalamate clearance test. The month 2 time point was selected as the “baseline” time point with respect to measured GFR due to logistical difficulty in obtaining measured GFR at the time of liver transplant and post-transplant renal function largely stabilizing by 2 months. All Measured GFR > 200 were truncated at 200.|Baseline (2 month), 12 months posttransplant|ITT population: all randomized and transplanted subjects. n = participants who had both baseline and postbaseline values.||mL/min/1.73m^2||Standard Deviation|Mean
129811|NCT00555321|Secondary|Number of Participants at Risk of First Acute Rejection as Determined by Kaplan-Meier Method by 12 Months|The time from transplantation to the first AR episode in each treatment arm was summarized using Kaplan-Meier curves. Acute Rejections were clinically suspected and biopsy proven by central pathologist.|3, 6, 9 and 12 months posttransplant|ITT population, all randomized and transplanted participants.||participants|||Number
129812|NCT00555321|Secondary|Number of Participants Having Acute Rejection by Rejection Activity Index During the LTE|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|Day 1 (randomization) through End of study (database lock of 20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered the long-term extension phase.||participants|||Number
129813|NCT00555321|Secondary|Number of Participants With Acute Rejections by Rejection Activity Index (RAI) by 12 Months|Acute Rejections were clinically suspected and biopsy proven by central pathologist. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI). An overall score of 0-2 is considered indeterminate, score of 3-4 is mild, score of 5-6 is moderate, and score of 7-9 is severe. Only the episode with the highest total RAI score for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants||participants|||Number
129814|NCT00555321|Secondary|Number of Participants Who Had Acute Rejection by Banff Grade by 12 Months|Acute Rejections (AR) were clinically suspected and biopsy proven by central pathologist. The Banff grading is a classification of renal allograft pathology and AR. Grade I: AR requiring moderate (>25%) to severe mononuclear cell interstitial infiltrate and moderate tubulitis; Grade II: AR requiring severe tubulitis and/or intimal arteritis; Grade III: AR requiring transmural arteritis. Only the episode with highest Banff grade for each participant was counted.|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants||participants|||Number
129815|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. DBL=database lock, TRT=treatment|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.||participants|||Number
129816|NCT00555321|Secondary|Number of Participants With Central Biopsy Proven Acute Rejection by Treatment Type by 12 Months|Acute rejections were clinically suspected and biopsy proven by central pathologist. Corticosteroid-resistant rejection = Continued rejection, as documented by liver biopsy, after the completion of 2 days of corticosteroids and requiring use of T-cell depleting agent. Refractory rejection=Continued rejection, as documented by liver biopsy, after use of corticosteroids and T cell depletion therapy. Increase in the dose of TAC was monitored in participants who were assigned to one of the TAC-based regimens. TRT= treatment|3, 6 and 12 months posttransplant|ITT population: all randomized and transplanted participants||participants|||Number
129817|NCT00555321|Secondary|Number of Participants Having Acute Rejections During the LTE|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long-term extension||participants|||Number
129818|NCT00555321|Secondary|Number of Participants Having Acute Rejections: 12-month Treatment Phase|Acute rejections were clinically suspected and biopsy proven by central pathologist. The number of episodes of AR was counted.|3 , 6, and 12 months|ITT population: all randomized and transplanted participants||participants|||Number
131492|NCT00541658|Secondary|Number of Patients With No New Fractured Vertebra, Week 52||Week 52|ITT Population||Participants|||Number
129819|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by End of Study (Includes LTE Data)|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a central histopathologist using Banff criteria. For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population: all randomized and transplanted participants who entered the Long term extension||percentage of participants||95% Confidence Interval|Number
129820|NCT00555321|Secondary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection, Graft Loss, or Death by 12 Months|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% CI within each group, normal approximation is used if N>=5. Otherwise exact method is used. For 95% CI of difference, adjustment is made for randomization strata if N >= 5 in each treatment arm.|At 12 months posttransplant|ITT population: all randomized and transplanted participants||percentage of participants||95% Confidence Interval|Number
129821|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft by End of Study (Includes LTE Data)|For 95% CI within each group, normal approximation was used if N>=5, otherwise exact method was used.|Day 1 (randomization) through database lock (20-June-2011)|ITT-LTE population, all randomized and transplanted participants who entered long term extension.||percentage of participants||95% Confidence Interval|Number
129822|NCT00555321|Secondary|Percentage of Participants Surviving With Functional Graft: 12-month Treatment Phase|For 95% CI within each group, normal approximation was used if N>=5. Otherwise exact method was used.|At 6 and 12 months|ITT population: all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
129823|NCT00555321|Primary|Percentage of Participants Who Experienced at Least One Episode of Acute Rejection (AR), Graft Loss, or Death by 6 Months Post-transplant|Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N>=5, otherwise exact method is used.|At 6 months posttransplant|Intent-to-Treat (ITT) population: all randomized and transplanted participants.||percentage of participants||95% Confidence Interval|Number
129824|NCT00555217|Secondary|A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD.|Time to the first event of reduction in estimated GFR of >50% (for individuals with baseline GFR <60) or reduction in GFR of >30 (for individuals with baseline GFR >= GFR 60) or ESRD.|From enrollment to time of first event, up to 4.5 years|||participants|||Number
129825|NCT00555217|Primary|A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death|Time to the first event of reduction in estimated GFR of 30ml/min/1.73m*m in individuals w/a baseline estimated GFR >= 60 ml/min/1.73m*m, reduction in estimated GFR >50% in individuals w/ baseline estimated GFR <60ml/min/1.73m*m; ESRD or death.|From enrollemnt to time of first primary event, up to 4.5 years|||participants|||Number
129826|NCT00555152|Primary|Incidence of Adverse Events Graded According to the National Cancer Institute (NCI) Common Terminology Criteria (CTCAE) Version 3.0|Toxicity profile summarized reflects incidence by number of participants affected with adverse events by Maximum Grade 1 to 3, additional adverse event according to the NCI CTCAE version 3.0 reported in Adverse Event section results.|From baseline to 4-5 weeks after surgery|||participants|||Number
129827|NCT00555152|Secondary|Biomarker Analysis of Proliferation Markers|Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, Up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.|||||
129828|NCT00555152|Secondary|Incidence of Ductal Carcinoma in Situ Remaining at Resection|Number of participants with DCIS incidence on surgical excision. Differences in histologic response (disappearance of DCIS) will be evaluated using Fisher’s exact test. Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.|2-6 weeks from baseline to surgery, up to 6 weeks|DCIS was present at the time of surgery in all patients.||participants|||Number
129829|NCT00555152|Primary|Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS)|Reduction in percent of Ki67 positive cells at surgery compared to baseline as a function of treatment. Analysis of the primary treatment comparison will be based on a two sample t-test comparing change in log-transformed Ki67% for placebo and treated subjects. P-values of 0.05 will be considered significant. Proliferation will be assessed by immunohistochemical (IHC) staining for Ki67, and the change in percentage of Ki67 positive cells will be compared in lapatinib-treated samples versus placebo.|2-6 weeks from baseline to surgery, up to 6 weeks|No outcome data available due to laboratory issues affecting the analysis of biomarkers results.|||||
129830|NCT00555061|Secondary|Number of Participants by Age With Therapeutic Response of Success|"Therapeutic response is a measure of the overall efficacy response; a response of therapeutic success was based on both clinical success and bacteriological success in a given participant."|Follow-up, Days 12 to 16|ITTB and ITTC Populations. The number analyzed is the number of participants who were clinical successes both in the ITTC Population and the ITTB Population; the number of participants who were therapeutic successes out of the total number in each respective category is shown.||participants|||Number
129844|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.||min||Standard Deviation|Mean
129831|NCT00555061|Secondary|Bacteriological Success Rate at Follow-up, by Baseline Pathogen|"Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as n in the category title) for each respective category is shown."|Follow-up, Days 12 to 16|ITTB (Intent-to-Treat Bacteriological) Population: participants who had at least one dose of study medication and a clinical diagnosis of infection plus a pathogen isolated at Baseline. Participants with more than one pathogen may be represented in the table more than once.||number of pathogens eradicated|||Number
129832|NCT00555061|Secondary|Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age|SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed.|Follow-up, Days 12 to 16|Intent-to-Treat Clinical (ITTC) Population: all participants who received at least one dose of study medication; the number of participants who were clinical successes out of the total number in each respective category is shown||participants|||Number
129833|NCT00555061|Primary|Number of Participants With Measurable Plasma Concentrations, by Age Group|Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.|Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day|Pharmacokinetic (PK) Population: all participants who received at least one dose of study medication and who had PK samples taken. Seven participants did not have PK samples collected.||participants|||Number
129834|NCT00555009|Secondary|Change From Baseline in Waist Circumference||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||cm||Standard Deviation|Mean
129835|NCT00555009|Secondary|Change From Baseline in Weight||Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||kg||Standard Deviation|Mean
129836|NCT00555009|Secondary|Change From Baseline in Cardiovascular Risk|The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).|Baseline, Weeks 2, 4, 12, 24, and 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
129837|NCT00555009|Secondary|Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36|The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 ‘Yes’ or ‘No’ statements covering 6 dimensions – mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
129838|NCT00555009|Secondary|Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36|A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||score on a scale||Standard Deviation|Mean
129839|NCT00555009|Secondary|Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36|The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
129840|NCT00555009|Secondary|Change From Baseline in Lean Body Mass and Fat Mass at Week 36|The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||kg||Standard Deviation|Mean
129841|NCT00555009|Secondary|Change From Baseline in CogState™ at Week 12 and 24.|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 12 and 24|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
129842|NCT00555009|Primary|Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36|CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.|Baseline, Week 36|Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.||scores on a scale||Standard Deviation|Mean
129895|NCT00554216|Primary|Percent Weight Loss From Baseline to Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
129845|NCT00554970|Primary|Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.||min||Standard Deviation|Mean
129846|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.||pg*min/ml||Standard Deviation|Mean
129847|NCT00554970|Primary|AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.||pg*min/ml||Standard Deviation|Mean
129848|NCT00554970|Primary|Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 8 hour 12|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Mean
129849|NCT00554970|Primary|Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|Day 1 hour 12|Patients with available data at specified time points are included in the analysis population.||pg/ml||Standard Deviation|Mean
129850|NCT00554853|Secondary|Rheumatoid Arthritis Disease Activity|"Quantification of disease activity using validated assessments (disease activity score on 28 joints (DAS28) and and C-reactive protein ( CRP) (Inflammatory marker) as a combined score (DAS-28CRP)).~Mean decrease in DAS-28-CRP score when compared to baseline was measured. The range of DAS-28-CRP is 0-10, with 0 meaning no active disease detected and 10 being the most severe active disease detected by joint count and C-reactive protein levels in blood."|8 mo|||mean decrease in DAS28-CRP score||Standard Deviation|Mean
129851|NCT00554853|Primary|Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia|This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study.|8 months|Vascular function parameters were performed in patients with rheumatoid arthritis at baseline and at completion of each arm , as well as at the beginning of crossover following washout period.||% changes in diameter of artery||Inter-Quartile Range|Mean
129852|NCT00554801|Secondary|Questionnaires Regarding Quality of Life||three years||||||
129853|NCT00554801|Primary|Audiological Test Results|Audiometric testing, with normal hearing specified as better (lower) than 25 decibels Hearing Level (dBHL), and a mild hearing loss between 25 to 50 dBHL.|three years|||decibels Hearing Level||Standard Deviation|Mean
129854|NCT00554749|Secondary|Number of Children Who Obtained the Different Treatment Modules (Level of Speaking;Level 1 Through to 6)|6 Predefined treatment goals reflecting speaking levels from 1 through to 6. 1: Speaks to the therapist(T) in a separate room in the kindergarten with parent (P) present. 2: Speaks to T in a separate room without P. 3: Speaks to a teacher in a separate room with T present. 4: Speaks to other teachers in a separate room with T present. 5: Speaks to teachers in some kindergarten settings without T present. 6: Speaks to teachers in all settings in kindergarten without T present. Each child receives one score at end of treatment according to their acquired level (worst value=1, best value =6)|6 months|All participants analyzed||participants|||Number
129855|NCT00554749|Primary|School Speech Questionnaire (SSQ)|SSQ is a teacher-report measure assessing the frequency of the child's speaking behaviour at school. It is a 9-item questionnaire. Each item has four possible responses, ranging 0 (never), 1 (seldom), 2 (often) and 3 (always). The standard sum score is added up from the six questions (as defined by its author Lindsey Bergman) and then divided by 6 to make up a corresponding factor score ranging from 0-3.(worst value=0 and best value=3)|6 months|||Units on a scale||Standard Deviation|Mean
129856|NCT00554671|Primary|Hemoglobin A1c|hemoglobin A1c|13 months|||percent Hemoglobin A1c||Standard Deviation|Mean
129857|NCT00554671|Secondary|Health-care Costs to the VHA|Institutional costs from health service utilization on the study patients during and 13 months after the intervention|13 months (during study) and 13 months (after the study) = 26 months||04/2015||||
129858|NCT00554671|Secondary|Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment||13 months||04/2015||||
129859|NCT00554671|Primary|Hemoglobin A1c||6 months|||percent Hemoglobin A1c||Standard Deviation|Mean
129860|NCT00554619|Primary|Number of Participants With Adverse Events Categorized by Severity|The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.|For 140.57 weeks at maximum, starting from Week 24|Safety Population||participants|||Number
129861|NCT00554619|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. BNP is a surrogate marker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||nanograms per liter (ng/L)||Standard Deviation|Mean
129862|NCT00554619|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|CO is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||Liters per minute (L/min)||Standard Deviation|Mean
129863|NCT00554619|Secondary|Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|mPAP is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||millimeters of mercury (mmHg)||Standard Deviation|Mean
129864|NCT00554619|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event|Time to clinical worsening was defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy (a surgical procedure in which a small hole is made in the wall between the left and right atria of the heart), or study discontinuation due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events up to 164.14 weeks.|Up to 164.14 weeks|FAS||participants|||Number
129865|NCT00554619|Secondary|Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|There are four grades for the WHO FC (Class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||participants|||Number
129866|NCT00554619|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)|FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.||scores on a scale||Standard Deviation|Mean
129867|NCT00554619|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 minus the baseline value. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Imputation technique was last observation carried forward, which was used in an attempt to compensate for missing data. For each participant, missing values were replaced with the last observed value.|Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156|Full Analysis Set (FAS): All participants registered, with the exception of those who did not receive any dose of the investigational product and those who had no efficacy assessment after treatment.||meters||Standard Deviation|Mean
129868|NCT00554619|Primary|Number of Participants With Any Adverse Event|An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.|For 140.57 weeks at maximum, starting from Week 24|Safety Population: Participants who had received at least one dose of the investigational product||participants|||Number
129869|NCT00554463|Secondary|Median and 2-year Rates of Progression-free and Overall Survival||After all patients have been potentially followed for 2 years||||||
129870|NCT00554463|Secondary|Incidence of Grade 4 Thrombocytopenia||At the completion of all treatment, approximately 80 days||||||
129871|NCT00554463|Secondary|Incidence of Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events as Assessed by NCI CTCAE v 3.0||At the completion of all treatment, approximately 80 days||||||
129872|NCT00554463|Secondary|Incidence of Dose Modifications or Treatment Delays||At the completion of all treatment, approximately 80 days||||||
129873|NCT00554463|Secondary|Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Adjuvant Chemotherapy as Assessed by NCI CTCAE v 3.0||At the completion of all treatment, approximately 80 days||||||
129874|NCT00554463|Primary|Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Concurrent Chemoradiotherapy as Assessed by NCI CTCAE v 3.0 (Common Terminology Criteria for Adverse Events)|This study stopped accrual early with 5 accrued out of 44 planned, therefore no analyses were performed.|At the completion of all treatment, approximately 80 days||||||
129875|NCT00554372|Secondary|Median Overall Survival|Overall survival after treatment in days|To 760 days post treatment|||days||95% Confidence Interval|Median
129896|NCT00554190|Primary|Number of Participants With Solicited and Recorded Adverse Events|All reported events were coded to a standard set of terms using the MedDRA adverse event dictionary. Adverse events were listed and summarized.|Post-operative through 60 days|There were 19 participants who completed the 60 day follow up visits for analysis.||Participants|||Number
129897|NCT00554190|Primary|Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale|Synechia (adhesion) scale range of 0 = No visible synechia to 3 = Complete scarring between the middle turbinate and lateral nasal wall was used in the assessment.|Post-operative through 60 days|There were 19 participants that completed the final follow-up visit at 60 days.||Participants|||Number
129876|NCT00554372|Secondary|Number of Subjects Achieving Disease Control as Determined Using Intrahepatic Modified RECIST Criteria|"Number of subjects achieving disease control (non-progressive disease) at 8 weeks after treatment was initiated based on modified Response Evaluation Criteria in Solid Tumors for Hepatocellular Carcinoma (mRECIST for HCC). mRECIST for HCC adopted the concept of viable tumor as tumor tissue showing uptake in arterial phase of contrast enhanced radiologic imaging techniques. (see Lencioni and Llovet, Semin. Liver Dis. 2010; 30:52-60). Per mRECIST for HCC, for target lesions as assessed by contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target (viable) lesions; Partial Response (PR), >=30% decrease in the sum of diameters of viable target lesions; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in viable target lesions.~Disease Control (DC) = CR or PR or SD."|At week 8|||participants|||Number
129877|NCT00554372|Secondary|Safety and Tolerability of JX-594 Administered at Two Dose Levels|Treatment-related serious adverse events in patients treated at two dose levels|Safety and tolerability were evaluated throughout the 8 week period of study participation|||serious adverse event|||Number
129878|NCT00554372|Primary|Proportion of Subjects Achieving Disease Control (Non-progressive Disease) at 8 Weeks After Initiation of Treatment|Proportion of subjects achieving disease control at 8 weeks based on a modified Response Evaluation Criteria in Solid Tumors v1.0 (mRECIST). Per mRECIST for target lesions as assessed by dynamic contrast enhanced dynamic MRI: Complete Response (CR), Disappearance of all tumor(s); Partial Response (PR), >=30% decrease in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum; Stable Disease (SD), any cases that do not qualify for PR or progressive disease (PD); PD, any increase of >= 20% in the sum of longest diameter (LD) of tumor(s) taking as reference the baseline sum. Disease Control (DC) = CR or PR or SD. For mRECIST criteria, new tumor(s) that developed within the liver were measured (a new tumor was defined as a malignant tumor not present at baseline, was ≥ 1 cm in LD had typical hypervascular features of HCC). Their maximum diameter(s) were included in the sum of the maximum diameter; new tumors were not considered evidence for progression.|Initial progression status and response assessment at 8 weeks from first dose|Patients having evaluable radiographic imaging, 2 patients in each arm were excluded due to unevaluable images, 1 patient in the low dose arm was excluded due to a protocol deviation||Proportion of evaluable participants||95% Confidence Interval|Number
129879|NCT00554294|Secondary|Parameters of Process Evaluation (Acceptance, Feasibility)||1,5 years||||||
129880|NCT00554294|Secondary|Water Flow of the Water Dispensers||one school year||||||
129881|NCT00554294|Secondary|Physical Activity and Inactivity||one school year||||||
129882|NCT00554294|Secondary|Intake of Drinks||one school year||||||
129883|NCT00554294|Primary|Overweight|Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)|one school year|||participants|||Number
129884|NCT00554229|Secondary|Pharmacokinetic Characteristics of ZD4054||PK samples were performed at randomisation, Week 4, Week 8 and Week 12||||||
129885|NCT00554229|Secondary|Time to Initiation of Chemotherapy|Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
129886|NCT00554229|Secondary|Time to Pain Progression|Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
129887|NCT00554229|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Median time (in months) from randomisation to first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
129888|NCT00554229|Secondary|Health Related Quality of Life|Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.|Patients were assessed at every visit|||Months||Inter-Quartile Range|Median
129889|NCT00554229|Secondary|Bone Metastases Formation|Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method|Patients were assessed every 12 weeks|||Months||Inter-Quartile Range|Median
129890|NCT00554229|Secondary|Incidence of Skeletal Related Events|Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method.|From date of randomization until occurrence of a skeletal related event, assessed up to 31 months|||Months||Inter-Quartile Range|Median
129891|NCT00554229|Secondary|Time to Use of Opiates|Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method|From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months|||Months||Inter-Quartile Range|Median
129892|NCT00554229|Secondary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline, using the Kaplan-Meier method|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months|||Months||Inter-Quartile Range|Median
129893|NCT00554229|Primary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method|From date of randomization until date of death, assessed up to 32 months|||months||Full Range|Median
129894|NCT00554216|Primary|Percentage of Subjects With at Least 5% Weight Loss at Week 56||baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percentage of participants|||Number
129901|NCT00554099|Secondary|Change in GSS From Baseline to Week 52 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 52|ITT Population||Scores on a Scale||Standard Error|Mean
129902|NCT00554099|Secondary|Change in GSS From Baseline to Week 12 - ITT Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|Baseline to Week 12|ITT Population||Scores on a Scale||Standard Error|Mean
129903|NCT00554099|Secondary|Percentage of Responders at Week 52 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|52 Weeks|ITT Population||Percentage of Participants|||Number
129904|NCT00554099|Secondary|Percentage of Responders at Week 12 - ITT Population|Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|ITT Population||Percentage of Participants|||Number
129905|NCT00554099|Primary|Global Symptom Score (GSS) at Week 12, Primary Efficacy Population|GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).|12 Weeks|Primary Efficacy Population - Subset of ITT population including only patients with GSS value at Week 12 and baseline GSS of at least 12.||Scores on a Scale||Standard Error|Mean
129906|NCT00553969|Primary|Change in Disease Score (DS) Among the Treatment Groups|The categorical data were scored as follows: normal 0 points, borderline1 point, abnormal 2 points. Point values from all parameters were summed to create the DS, with values ranging from 0 to 20. Radial artery pulse waves and BP were measured to calculate small and large-artery elasticity using pulse contour analysis; sitting BP measurements; exercise BPs taken before, during and after exercise; optic fundus photos were taken with a digital camera; electrocardiogram; carotid intimal-media thickness and left ventricular ultrasound for LV mass; microalbuminuria; N-terminal pro B-type natriuretic peptide.|Baseline and nine months|Calculation for change is the value at the later time point minus the value at the earlier time point.||Overall Rasmussen Disease Score Change||Standard Deviation|Mean
129907|NCT00553969|Secondary|Quantitative Change in Each of the RDS Components From Baseline to 9 Months Will Serve as a Secondary End-point. The 3-month Data Will Provide Early Evidence for Drug Efficacy and Will be Analyzed Similarly as a Secondary End-point.||3-9 months||||||
129908|NCT00553969|Primary|The Overall Rasmussen Disease Score (RDS) Change From Baseline to 9 Months Will be the Primary End-point.||9 months||||||
129909|NCT00553839|Primary|Residual Error|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Residual Error was analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease||proportional %||95% Confidence Interval|Median
129910|NCT00553839|Primary|Central and Peripheral Volume of Distribution|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Central and Peripheral Volume of Distribution were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease||L/70kg||95% Confidence Interval|Median
129911|NCT00553839|Primary|Total Clearance and Intercompartmental Clearance|"pK analysis of ketamine in children with pre-existing congenital heart disease following a single dose of ketamine in order to rationalize an effective 2-h anesthetic medication, personalized based on cardiac function and age.~Total Clearance and Intercompartmental Clearance were analyzed using Bootstrap model."|5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.|Children up to 18 years of age children with pre-existing congenital heart disease||L/h/70kg||95% Confidence Interval|Median
129912|NCT00553787|Primary|Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percentage of participants|||Number
129913|NCT00553787|Primary|Percent Weight Loss From Baseline to Week 56||Baseline to 56 weeks|intent-to-treat last-observation-carried-forward (ITT-LOCF)||percent weight loss||Standard Error|Least Squares Mean
129914|NCT00553696|Secondary|Time to Progression (TTP)|Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).||Months||95% Confidence Interval|Median
129915|NCT00553696|Secondary|Progression-Free Survival (PFS)|Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).||Months||95% Confidence Interval|Median
129916|NCT00553696|Secondary|Duration of Response (DR)|Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).|Baseline up to 739 days|A subgroup of participants with an objective tumor response among Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)||Months||95% Confidence Interval|Median
129917|NCT00553696|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib).||participants|||Number
129918|NCT00553696|Secondary|Number of Participants With Objective Response|Number of participants with objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.|Baseline up to 739 days|Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib)||participants|||Number
129919|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||ng*h/mL||Standard Deviation|Mean
129920|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||hrs||Full Range|Median
129921|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum||Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)|Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
129922|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||ng*h/mL||Standard Deviation|Mean
129923|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||hrs||Full Range|Median
129924|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU||Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)|Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
129925|NCT00553696|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||ng*h/mL||Standard Deviation|Mean
129926|NCT00553696|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||hrs||Full Range|Median
129927|NCT00553696|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)||Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)|Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
129928|NCT00553696|Primary|Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)|A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).|Cycle 1 (Baseline to Week 4)|DLT Evaluation Set consisted of participants who were initially enrolled for the determination of maximam tolerated dose (MTD), and either 'experienced DLT' or 'received all of the Day 1 chemotherapy, received at least 80% of their sunitinib doses, and at least 80% of S-1 doses'.||participants|||Number
129929|NCT00553644|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method.|Assessed up to 6 years||||||
129930|NCT00553644|Secondary|Time to Progression|Analyzed using the Kaplan-Meier method.|Assessed up to 6 years||||||
129931|NCT00553644|Secondary|Incidence of Adverse Events|Toxicity data will be summarized using frequency tables. The description and grading scales found in the revised NCI CTCAE version 4.0 will be utilized for adverse event reporting.|Assessed up to 6 years||||||
129932|NCT00553644|Primary|Number of Participants With an Overall Response Defined as Complete Response and Partial Response|"Response is assessed by investigator according to International Working Group (IWG) criteria.~A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease."|Duration of treatment (assessed up to 6 years)|||participants|||Number
130135|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients||Participants|||Number
129933|NCT00553631|Secondary|Time to Response- Comparison of GA-GCB and Imiglucerase on the Earliest Time to Respond as Assessed Via Hemoglobin Concentration|Time to response was defined as a ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline. Units (%) correlates to the percentage of participants who had a change of ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline during their participation in the study.|Response rate at Month 9 compared to Baseline|ITT population||Percentage of participants|||Number
129934|NCT00553631|Secondary|Number of Participants Who Developed Antibody for Each Treatment Group.|Measure type is actual number of participants who developed antibodies to treatment; GA-GCB or imiglucerase. Antibody detection was based upon serum samples collected at various time points throughout the study. Serum samples were screened using an enzyme-linked immunosorbent assay (ELISA) and positive antibody confirmation was determined using a radioimmunoprecipitation assay (RIP); positive samples were also tested for enzyme neutralizing activity. Participant samples were compared to internal assay controls (positive/negative), positive samples were determined based upon individual assay criteria.|Baseline to Month 9|Safety population comprised of all randomized participants who received at least 1 full or partial dose of study drug.||participants|||Number
129935|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chemokine (C-C Motif) Ligand 18 (CCL18) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.||nanogram per milliliter (ng/mL)||Standard Error|Mean
129936|NCT00553631|Secondary|Change From Baseline to Month 9 in Plasma Chitotriosidase for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Units of measure is defined as nanomole per milliliter per hour.|Baseline to Month 9.|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Chitotriosidase levels were measured in 10 participants in the velaglucerase alfa group and 11 participants in the imiglucerase group.||nanomole/milliliter/hour (nmol/mL/h)||Standard Error|Mean
129937|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Spleen Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to month 9. Measured by Magnetic resonance imaging (MRI). Spleen volume was normalized for percent (%) of body weight for each treatment arm. Spleen size relative to body weight=(Spleen volume [cc]/Body weight [kg])*100.|Baseline to Month 9|ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Ten participants in each treatment group underwent splenectomy, and therefore, were excluded from the analysis.||cm^3||Standard Error|Mean
129938|NCT00553631|Secondary|Change From Baseline to Month 9 in Normalized Liver Volume (Percent (%) Body Weight) for Each Treatment Group.|Values shown are observed change from Baseline to Month 9. Measured by Magnetic resonance imaging (MRI). Liver volume has been normalized for percent (%) body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cubic centimeter (cc)]/Body weight [kg]*1000.|Baseline to Month 9|ITT population.||cubic centimeter (cm^3)||Standard Error|Mean
129939|NCT00553631|Secondary|Change From Baseline to Month 9 in Platelet Counts for Each Treatment Group.|Values shown are observed change from Baseline to Month 9.|Baseline to Month 9|ITT population.||10^9 per liter (10^9/L)||Standard Error|Mean
129940|NCT00553631|Primary|Mean Change From Baseline to Month 9 in Hemoglobin (Hgb) Concentration for Each Treatment Group.||Baseline to Month 9|Intent-to-treat (ITT) population comprised of all randomized participants who received at least 1 full or partial dose of study drug.||gram per deciliter (g/dl)||Standard Error|Mean
129941|NCT00553605|Secondary|Number of Participants With Use of Rescue Medication (RM)|Rescue medications included intravenous 0.1 to 0.2 mg/kilogram (kg) of morphine or 1 mg/kg of pethidine or muscle relaxants.|Up to Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.||participants|||Number
129942|NCT00553605|Secondary|Physician’s Global Evaluation of Study Medication|Physicians’ response to the question “How would you rate the study medication the patient received for pain?” on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated.|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
129943|NCT00553605|Secondary|Patient’s Global Evaluation of Study Medication|"Participants' response to the question How would you rate the study medication you received for pain?” on a 4-point categorical scale, 1=Poor, 2= Fair, 3=Good, 4=Excellent was evaluated."|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
129944|NCT00553605|Secondary|Number of Participants With Response in Pain Intensity|PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. Responders were those who had a decreased in VAS of at least 20 mm.|Minute 30|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
129945|NCT00553605|Secondary|Number of Participants With Pain Relief (PR)|PR was assessed on a 5-point categorical pain relief rating scale wherein 0= None, 1= a little, 2= Some, 3= a lot and 4= Complete relief.|Minute 30, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||participants|||Number
129946|NCT00553605|Secondary|Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)|TOTPAR: time-weighted sum of Pain Relief (PR) over 120 min. TOTPAR score range was 0 (worst) to 480 (best). PR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|Baseline through Minute 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.||units on a scale||Standard Error|Least Squares Mean
130136|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients||Participants|||Number
129947|NCT00553605|Secondary|Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120|PID score was obtained by subtracting the PI-VAS at each time point from baseline PI score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain. PID score ranged from -100 to 100. Positive score= improved response in pain.|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time points for each treatment arm respectively.||mm||Standard Deviation|Mean
129948|NCT00553605|Secondary|Time-specific Pain Intensity (PI) VAS Score|PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 mm line, with 0 mm=no pain, 100 mm= worst possible pain.|Baseline, Minute 15, 30, 45, 60, 90, 120|mITT included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.||mm||Standard Deviation|Mean
129949|NCT00553605|Secondary|Mean Pain Intensity Difference at 120 Min (mPID120min)|mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 120 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 120 from baseline PI-VAS score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.|Minute 120|Modified intent- to-treat (mITT) included all randomized participants who received at least 1 dose of the study drug with at least 1 post-baseline pain assessment.||mm||Standard Error|Least Squares Mean
129950|NCT00553605|Primary|Mean Pain Intensity Difference at 30 Minutes (mPID30min)|mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question “How much pain are you having right now?” on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.|Minute 30|Per-protocol (PP): all randomized participants who received at least 1 dose of study drug; had 1 post-baseline pain assessment; no major protocol violations; received appropriate dose of study drug; had valid baseline, 15 and 30 min VAS pain assessments; did not take rescue medications for 30 min; had confirmed diagnosis of nephrolithiasis.||mm||Standard Error|Least Squares Mean
129951|NCT00553514|Secondary|Number of Follicles With Mean Diameter Less Than (<) 11 Millimeter (mm) and Greater Than or Equal to (>=) 11 mm||Stimulation Day 5 (S5), S7 and r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.||Follicles||Standard Deviation|Mean
129952|NCT00553514|Secondary|Cumulative Dose of Supplemental Follitropin Alfa Administered||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||IU||Standard Deviation|Mean
129953|NCT00553514|Secondary|Duration of Supplemental Follitropin Alfa Treatment||Stimulation Day 7 (S7) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Standard Deviation|Mean
129954|NCT00553514|Secondary|Duration of Ovarian Stimulation|Ovarian stimulation included from first dose of study drug on S1 until day on which r-hCG was administered (r-hCG day).|Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Standard Deviation|Mean
129955|NCT00553514|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 14 days])|PP population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percentage of participants|||Number
129956|NCT00553514|Primary|Percentage of Participants With Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level >= 30 nanomole per liter (nmol/L) (10 nanogram per milliliter [ng/mL]). In the absence of a positive progesterone response, clinical pregnancy was also considered as evidence of ovulation.|Mid-luteal phase progesterone assessed 5-10 days or clinical pregnancy 35-42 days after recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 14 days])|Per Protocol (PP) population included all the randomized participants who were without a medically relevant protocol deviation. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percentage of participants|||Number
129957|NCT00553501|Post-Hoc|3-Year Overall Survival|Percentage of participants who were alive at 3 years. The 3 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|3 years|||percentage of participants||95% Confidence Interval|Number
129958|NCT00553501|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||years||95% Confidence Interval|Median
130137|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients||Participants|||Number
129960|NCT00553475|Primary|Change From Baseline at Week 13 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.~Change from baseline: Score at Week 13 minus score at baseline"|From baseline to Week 13|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129961|NCT00553475|Secondary|Patient Global Impression of Change|The Patient Global Impression of Change is a patient-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
129962|NCT00553475|Secondary|Clinical Global Impression of Change|Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 13 or up to discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
129963|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129964|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129965|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129966|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129967|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129968|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129969|NCT00553475|Secondary|Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance|The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129970|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129971|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||mm||Standard Error|Least Squares Mean
129972|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129973|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129974|NCT00553475|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129975|NCT00553475|Secondary|Change From Baseline in Mean Sleep Interference Scores|The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129976|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129977|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129978|NCT00553475|Primary|Change From Baseline at Week 12 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.~Change from baseline: Score at Week 12 minus score at baseline"|From baseline to Week 12|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129979|NCT00553475|Primary|Change From Baseline at Week 11 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.~Change from baseline: Score at Week 11 minus score at baseline"|From baseline to Week 11|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129980|NCT00553475|Primary|Change From Baseline at Week 10 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.~Change from baseline: Score at Week 10 minus score at baseline"|From baseline to Week 10|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129981|NCT00553475|Primary|Change From Baseline at Week 9 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.~Change from baseline: Score at Week 9 minus score at baseline"|From baseline to Week 9|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129982|NCT00553475|Primary|Change From Baseline at Week 8 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.~Change from baseline: Score at Week 8 minus score at baseline"|From baseline to Week 8|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129983|NCT00553475|Primary|Change From Baseline at Week 7 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.~Change from baseline: Score at Week 7 minus score at baseline"|From baseline to Week 7|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129984|NCT00553475|Primary|Change From Baseline at Week 6 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.~Change from baseline: Score at Week 6 minus score at baseline"|From baseline to Week 6|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129985|NCT00553475|Primary|Change From Baseline at Week 5 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.~Change from baseline: Score at Week 5 minus score at baseline"|From baseline to Week 5|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129986|NCT00553475|Primary|Change From Baseline at Week 4 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.~Change from baseline: Score at Week 4 minus score at baseline"|From baseline to Week 4|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129987|NCT00553475|Primary|Change From Baseline at Week 3 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.~Change from baseline: Score at Week 3 minus score at baseline"|From baseline to Week 3|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129988|NCT00553475|Primary|Change From Baseline at Week 2 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.~Change from baseline: Score at Week 2 minus score at baseline"|From baseline to Week 2|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129989|NCT00553475|Primary|Change From Baseline at Week 1 in Mean Weekly Pain Scores|"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.~Change from baseline: Score at Week 1 minus score at baseline"|From baseline to Week 1|Full analysis set. Observed case (No imputation).||score on scale||Standard Error|Least Squares Mean
129990|NCT00553475|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||participants|||Number
129991|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
130138|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients||Participants|||Number
129992|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129993|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129994|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129995|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129996|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129997|NCT00553475|Secondary|Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning|The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129998|NCT00553475|Primary|Change From Baseline to Study Endpoint in Mean Weekly Pain Scores|Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.|From baseline to Week 13 or up to study discontinuation (Study Endpoint)|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
129999|NCT00553462|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from registration to disease progression or death of any cause, which ever comes first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)|||months||95% Confidence Interval|Median
130000|NCT00553462|Secondary|Response Rate|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Response rate is reported as the percentage of participants who achieved each response."|Duration of study (up to 2 years)|||percentage of participants|||Number
130001|NCT00553462|Primary|Overall Survival at 12 Months|Percentage of participants who were alive at 12 months.|At 12 months|||percentage of participants||95% Confidence Interval|Number
130002|NCT00553436|Primary|Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)|Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.|At The Time of Surgery|All enrolled subjects were analyzed||participants|||Number
130003|NCT00553436|Secondary|Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition||3 month follow-up|All enrolled subjects were analyzed||Participants|||Number
130004|NCT00553436|Secondary|Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.|The total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.|3 month follow-up|||participants|||Number
130005|NCT00553358|Secondary|Number of Circulating Tumor Cells (CTC) in the Bloodstream|Circulating tumor cells (CTCs) are cells that have detached from a primary tumor and circulate in the bloodstream. In the adjuvant phase, after surgery all participants received 3 courses of adjuvant 5-fluorouracil, epirubicin and cyclophosphamide, followed by lapatinib 1500 mg or trastuzumab 2 mg/kg or lapatinib 1000/750 mg plus trastuzumab 2 mg/kg given prior to surgery in the neoadjuvant setting for an additional 34 weeks. Data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2 of neo-adjuvant phase (Weeks 1-34), at surgery (Weeks 20 to 22), Week 10 of adjuvant phase, 6 months after completion of adjuvant treatment, and at recurrence||08/2021||||
130006|NCT00553358|Secondary|Number of Participants With the Indicated Biomarker Expression|Biomarker levels (Ki67, p27, Cyclin-D1, ErbB1, ErbB2, ErbB3, pErbB1, pErbB2, Akt and pAkt, S6 and pS6, MAPK and pMAPK, c-myc, IGFR1, p95HER2, PTEN, ER (alpha, beta), PgR,CD34, terminal deoxynucleotidyl transferase biotin-dUTP nick and labelling technique [TUNEL] and topoisomerase II) were assessed in participants. Blood and tumor tissue samples were collected at Baseline and at Weeks 2 and 20-22; however, data for this outcome measure cannot be presented at this time as they have yet to be evaluated and reviewed.|Baseline, Week 2, and at surgery (Weeks 20 to 22)||08/2021||||
130022|NCT00553332|Primary|Objective Response Rate (CR and PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 8 weeks|||patients|||Number
130007|NCT00553358|Secondary|Number of Participants With Metabolic Response of Complete Response (mCR), Partial Response (mPR), or Stable Disease (mSD) as Determined by Positron Emission Tomography/Computed Tomography (PET/CT)|European Organisation for Research and Treatment of Cancer recommendations were used to define metabolic response. mCR, complete metabolic response: complete resolution of fludeoxyglucose uptake within tumor, indistinguishable from surrounding normal tissue. mPR, partial metabolic response: reduction of more than 25% of maximum tumor standard uptake value (SUV). mSD, stable metabolic disease: increase of <25% in tumor SUV or decrease of >20% in tumor SUV. mPD, progressive metabolic disease: increase of >25% in tumor SUV or >20% in the extent (longest dimension) or appearance of new metastases.|Baseline, Week 2, and Week 6||08/2021||||
130008|NCT00553358|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from surgery to the first date of breast cancer relapse, second primary tumor (including contralateral breast cancer), or death without documented prior relapse. Data will be reported when they are mature and available, likely when a median of 3 years follow up has been reached.|Following surgery, every 12 months until Year 10||01/2019||||
130009|NCT00553358|Secondary|Overall Survival|Overall survival was defined as the period from surgery until death (from any cause). Data will be reported when they are mature and available; OS is assessed annually for up to 10 years after the randomization of the last participant into the study.|Following surgery, every 12 months until Year 10||01/2020||||
130010|NCT00553358|Secondary|Number of Participants Starting Paclitaxel Before Completing 6 Weeks of Treatment With Either Lapatinib or Trastuzumab|Participants with progressive disease at 4 week assessment that were permitted to commence treatment with paclitaxel.|Week 6|ITT Population. Participants who did not start any treatment were excluded from analysis.||participants|||Number
130011|NCT00553358|Secondary|Estimate of Treatment Contrast for Change From Baseline in Tumor Size at Week 6 and at Surgery|Estimate of treatment contrast is defined as the estimate of the difference between treatment groups in the change from baseline in tumor size. Change from baseline in tumor size was defined as tumor size at Week 6/ surgery (Weeks 20 to 22) minus tumor size at baseline. The difference in treatment arms was estimated for Lapatinib 1500 mg versus Trastuzumab 2 mg/kg and for Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg versus Trastuzumab 2 mg/kg.|Week 6 and surgery (Weeks 20 to 22)|ITT Population||millimeters||Standard Deviation|Mean
130012|NCT00553358|Secondary|Number of Participants With Actual Indicated Surgery|Participants were assessed for the type of surgery they underwent for breast cancer. Non-conservative surgery is defined as a radical or modified radical mastectomy. Conservative surgery is comprised of a lumpectomy, a quadrantectomy/segmentectomy, or a partial mastectomy. Participants who were not assessed as being candidates for non-conservative or conservative surgery were classified as non-operable.|At surgery (Weeks 20 to 22)|ITT Population||participants|||Number
130013|NCT00553358|Secondary|Number of Participants With Negative Lymph Nodes at the Time of Surgery|Participants were assessed for node-negative lymph nodes at the time of surgery. As per the pathological TNM (Tumor, Node, Metastases) classification (pTNM) of malignant tumors: pN, absence or presence and extent of regional lymph node metastasis. Node-negative (pN0) participants had no regional lymph node metastasis. Although not assessed in this measure, pT is the extent of primary tumor, and pM is the absence or presence of distant metastasis.|Time of surgery (Weeks 20 to 22)|ITT Population. Participants with a lymph node status of pNX (i.e., regional lymph nodes cannot be assessed) were omitted from the analysis of node-negative participants.||participants|||Number
130014|NCT00553358|Secondary|Number of Participants With Overall Response at the Time of Surgery|The number of participants with overall response (complete response and/or partial response) was evaluated using WHO criteria by clinical examination and mammography and breast echography with bi-dimensional measurements at the time of surgery (Weeks 20 to 22). As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Time of surgery (Weeks 20 to 22)|ITT Population||participants|||Number
130015|NCT00553358|Secondary|Number of Participants With Overall Response at Week 6|The number of participants with overall response (complete response and/or partial response) was evaluated using World Health Organization (WHO) criteria by clinical examination and by mammography and breast echography with bi-dimensional measurements at Week 6. As per WHO criteria: complete response is defined as the disappearance of all lesions; partial response is defined as a greater than 50% decrease in the sum of products of the greatest length and width of the largest lesion; progressive disease is defined as a greater than 25% increase in the sum of products of all measurable lesions.|Week 6|ITT Population||participants|||Number
130016|NCT00553358|Primary|Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery|Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.|Weeks 20 to 22|Intent-to-Treat (ITT) Population: all participants randomized to treatment, except for those who withdrew their consent to use any of their data (permitted by law in certain countries) prior to receiving any study medication||participants|||Number
130017|NCT00553332|Secondary|Protein Levels of RAS/RAF/MEK/ERK Signaling Pathway Activation|Measure the proteins levels of RAS/RAF/MEK/ERK signaling pathway activation to AZD6244|At baseline|Only 27 patients had pAKT and pERK performed due to 2 samples not available for analysis||mg/ml||Standard Deviation|Mean
130018|NCT00553332|Secondary|RAS/RAF/MEK/ERK Signaling Pathway Activation||At baseline|Data was not collected and analyzed|||||
130019|NCT00553332|Secondary|Overall Survival||Up to 12 months|Kaplan-Meier||months||95% Confidence Interval|Median
130020|NCT00553332|Secondary|Median Progression Free Survival for Patients|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 6 months|||months||95% Confidence Interval|Median
130021|NCT00553332|Secondary|Toxicity Profile of AZD6244|Toxicitity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|From the time of first treatment with AZD6244, assessed up to 4 weeks|||percent of patients|||Number
130024|NCT00553319|Primary|Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use|Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE <300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.|weekly for 14 weeks of trial or for length of participation|||percentage of participants|||Number
130025|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
130026|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||mm||Standard Deviation|Mean
130027|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
130028|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
130029|NCT00553280|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores|The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.|From baseline to 52 weeks or study discontinuation (Study Endpoint)|Full analysis set. No imputations for missing data.||score on scale||Standard Deviation|Mean
130030|NCT00553280|Primary|Summary of Adverse Events|Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.|53 weeks|Safety analysis set: all participants who had received at least one dose of the study drug.||participants|||Number
130031|NCT00553267|Secondary|Peripheral Oedema Incidence Rate|The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)|During randomised treatment period|||Number of cases/100 patient-years|||Number
130032|NCT00553267|Secondary|Oedema Incidence Rate|The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)|During randomised treatment period|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Number of patients/100 patient-years|||Number
130033|NCT00553267|Secondary|Trough Seated BP Normality Classes|The number of patients who reach predefined BP categories|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
130034|NCT00553267|Secondary|Trough Seated SBP Response|The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
130035|NCT00553267|Secondary|Trough Seated SBP Control|The number of patients who reach the target SBP of <140mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
130036|NCT00553267|Secondary|Trough Seated DBP Response|The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
130037|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure <80 mmHg|The number of patients who reach the target DBP of <80mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
130038|NCT00553267|Secondary|Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)|The number of patients who reach the target DBP of <90mmHg|End of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||Participants|||Number
130039|NCT00553267|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure|Change from baseline to the end of study in trough SBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||mmHg||Standard Error|Least Squares Mean
130040|NCT00553267|Primary|Change From Baseline in Trough Seated Diastolic Blood Pressure|Change from baseline to the end of study in trough DBP|Baseline and end of study (8 weeks or last value on treatment)|Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward||mmHg||Standard Error|Least Squares Mean
130041|NCT00553150|Secondary|Overall Survival Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 15 years|||months||95% Confidence Interval|Median
130042|NCT00553150|Secondary|Progression-free-survival at 6 Months (Phase II)|Progression-free-survival at 6 months: is the proportion of patients alive and progression-free at 6 months after start of regimen. This proportion will be estimated using the binomial point estimator and the binomial 95% confidence interval estimated.|at 6 months|||proportion of participants||95% Confidence Interval|Number
130043|NCT00553150|Secondary|Time to Progression (Phase II)|Time to progression: Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy. Patients who experience major treatment violations will be censored for progression on the date of treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method.|Up to 5 years|||months||95% Confidence Interval|Median
130044|NCT00553150|Secondary|Response Rate, as Measured in Patients Receiving FLT-PET Imaging (Phase II)|The response rate is defined as the percentage of patients receiving F-fluorothymidine positron emission tomography (FLT-PET) imaging whose cancer shrinks or disappears after treatment. A reduction in standardized uptake value (SUV) of 30% or greater in the T1-post-gadolinium scan volume of interest (T1-gad VOI) or the total tumor VOI will be considered a responsive tumor.|Up to 5 years|Of the 11 patients with measurable residual disease and pre-everolimus FLT-PET imaging, 2 did not have a second FLT-PET scan performed due to technical difficulties with FLT production, leaving 9 patients who could be assessed for changes in FLT uptake.||percentage of participants||95% Confidence Interval|Number
130045|NCT00553150|Primary|Overall Survival at 12 Months (Phase II)|"The primary endpoint is overall survival at 12 months (OS12) after entry into this study. The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. A patient who is evaluable and survive more than 12 months (i.e. 365 days or more) after start of therapy will be classified as a “success”. Patients who die within 12 months after start of therapy will be considered to have failed”."|at 12 months|||proportion of participants||95% Confidence Interval|Number
130046|NCT00553150|Primary|Maximum Tolerated Dose (MTD) of Everolimus (RAD001) in Combination With Temozolomide (TMZ) and 3D-conformal Radiotherapy (RT) or Intensity-modulated Radiotherapy (IMRT) Followed by Adjuvant TMZ With or Without RAD001 (Phase I)|Patients were assessed during RT for dose-limiting toxicities (DLT), which were defined as failure to deliver greater than 75% of the planned doses of TMZ or RAD001 during RT, interruption of RT for more than 5 days because of toxicity, or the following: >= Grade 3 diarrhea or skin rash; >= Grade 4 neutropenia, leukopenia, or thrombocytopenia; >= Grade 4 hypertriglyceridemia, hypercholesterolemia, or hyperglycemia despite optimal medial management, other >= 3 non-hematologic events; or >= Grade 4 radiation dermatitis. Maximum tolerated dose (MTD) was defined a priori as the highest dose level at which 0 or 1 of 6 patients developed DLTs. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.|Up to 49 days|Eighteen patients were enrolled in Phase I of the study to determine the maximum tolerated dose (MTD). The dosage of RAD001 was escalated in cohorts of 6 patients.||participants who developed DLTs|||Number
130047|NCT00552812|Secondary|Systolic Blood Pressure, Difference Between Upper and Lower Extremities|Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.|Baseline and 12 months|Comparison between baseline(n=105) and 12 month follow up (n=92)||mmHg||Standard Deviation|Mean
130048|NCT00552812|Secondary|Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement|Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure > 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).|Baseline and 12 months|Study patients compared at baseline and within the 12 month follow up window: Baseline (n=105) compared to 12 month follow up (n=92)||percentage of participants|||Number
130049|NCT00552812|Primary|Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months|Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)|12 months|||mmHg||Standard Deviation|Mean
130050|NCT00552786|Secondary|Temporary Threshold Changes Measurement by Distortion Product Otoacoustic Emissions (DPOAE) (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|Distortion product otoacoustic emissions (DPOAE) is an objective measure to assess the cochlear changes. DPOAE response threshold at high frequency (HF) was defined as the average of response levels (dB SPL) at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by DPOAE were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of DPOAE temporary threshold change was calculated by subtracting the pre-shift DPOAE response threshold from the post-shift DPOAE response threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had all 4 post-baseline assessments (measurements at beginning of 1st and 2nd intervention periods and end of 1st and 2nd intervention periods).||decibels (dB SPL)||Standard Deviation|Mean
130051|NCT00552786|Primary|Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and Post-shift, and the 14th Day Pre- and Post-shift)|The hearing threshold level (HL) at high frequency (HF) by pure-tone audiometry (PTA) was defined as the average of HLs at 3k,4k,6kHz for each ear examined. A total of four hearing assessments by PTA were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift. The amount of temporary threshold change was calculated by subtracting the pre-shift hearing threshold from the post-shift hearing threshold at each frequency.|A total of four hearing assessments were completed for each formulation period on the 1st day pre- and post-shift, and the 14th day pre- and post-shift|Intent to treat analysis including only participants who had at least one post-baseline assessment.||decibels||Standard Deviation|Mean
130052|NCT00552760|Secondary|Cumulative Proportion of Participants in Each Arm Surviving Without Relapse|Survival analysis techniques, including Kaplan Meier curves, were used to evaluate group differences in time to relapse. Relapse was defined as a medication initiation or change for manic/depressed/mixed symptoms, a hospitalization for manic/depressed/mixed symptoms, MADRS score >= 16, YMRS score > 14, and suicide risk or imminent risk of suicide. Time to relapse was measured discretely in terms of the number of assessment visits until discontinued from the study.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.||Cumulative proportion of participants|||Number
130053|NCT00552760|Secondary|Clinical Global Impressions Bipolar Version(CGI-BP) Severity of Illness Overall Score|3-part (mania, depression, overall bipolar illness), physician-administered scale used to assess global illness severity; used to measure change. Each part is rated from 1-7, higher scores represent more severe mental illness. Only overall bipolar rating was used.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures||units on scale||Standard Error|Mean
130054|NCT00552760|Secondary|Young Mania Rating Scale (YMRS) Total Score|11-item standardized, well-validated scale used to measure manic symptoms; sensitive to treatment effects in manic patients. Scores range from 0-60, higher scores represent more severe manic symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures||units on scale||Standard Error|Mean
130055|NCT00552760|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|10-item, standardized, well-validated scale used to measure severity of depressive symptoms; sensitive to treatment effects in depressed outpatients. Scores range from 0-60, higher scores represent more severe depressive symptoms.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures||units on scale||Standard Error|Mean
130056|NCT00552760|Primary|Pittsburgh Sleep Quality Index (PSQI) Global Score|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0-21, higher scores represent more significant sleep disturbance.|Monthly for 6 months|Intent to Treat Analysis; excludes 7 screen failures.||units on scale||Standard Error|Mean
130057|NCT00552695|Primary|Pain on Visual Analog Scale (VAS)|Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).|0 MINUTES|||mm||Inter-Quartile Range|Median
130058|NCT00552695|Secondary|Success of Intravenous (IV) Insertion|Percentage of patients in whom intravenous catheter was inserted successfully|After first attempt of catheter insertion|||Percentage of participants|||Number
130059|NCT00552669|Secondary|Target Vessel Revascularization (TVR)|Efficacy end point was TVR as revasacularization of the treated vessel.|18 months|We analyzed the number of vessels treated per group by ITT and the imputation technique was LOCF.||vessels|||Number
130060|NCT00552669|Secondary|Major Adverse Cardiovascular Events (MACCE)|Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.|18 Months|It was determinated by ITT and the technique used was LOCF.||participants|||Number
130061|NCT00552669|Primary|Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.|Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.|Follow up will be conducted by the coordinating Center at 18 months of follow up|All patients were analyzed for ITT and the imputation technique was LOCF||US dollars||Standard Deviation|Mean
130062|NCT00552578|Secondary|Treatment Retention.|"Treatment retention was defined as the completion of the buprenorphine dosing protocol (i.e., tapering doses vs. steady doses)."|Six months|Analysis was intent-to-treat.||Participants|||Number
130063|NCT00552578|Secondary|Number of Participants With Better Overall Quality of Life at Six Months as Compared to Baseline.|Qualitative measure (better/no change/worse) of participant's perception of overall quality of life related to assigned study protocol arm.|Baseline and six months|"Reported value (number) was the number who reported a better overall quality-of-life to the question: How would you describe your overall level of function now as compared to the time right before you started the study? Responses were recorded as: better, no change, or worse."||Participants|||Number
130064|NCT00552578|Primary|Relapse to Substance Abuse|Relapse to substance abuse (yes/no) was determined by participant self-report or by a positive urine toxicology.|Six months|||participants|||Number
130065|NCT00552513|Secondary|In-hospital Major Bleeding||Hospital discharge||||||
130066|NCT00552513|Secondary|Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180||180 days||||||
130067|NCT00552513|Secondary|Stroke at 30 Days and 180 Days||180 days||||||
130068|NCT00552513|Secondary|Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days||180 days|||Eparticipants|||Number
130069|NCT00552513|Secondary|First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia||180 days|||participants|||Number
130070|NCT00552513|Primary|Composite of Death, Myocardial (re-) Infarction, or Stroke||180 days|All patients were included in the final intention-to-treat analysis. Event rates in the two groups were estimated with the use of the Kaplan–Meier method. The hazard ratio and two-sided 95% confidence intervals were calculated with the use of a Cox proportional-hazards model.||participants|||Number
130071|NCT00552448|Secondary|Number of Participants With Chest Discomfort||During PICU admission|||participants|||Number
130072|NCT00552448|Secondary|Pediatric Asthma Severity Score (Modified Pulmonary Index Score)|Modified Pulmonary Index Score (MPIS): a validated asthma severity score in pediatric population (Carroll CL et al. A modified pulmonary index score with predictive value for pediatric asthma exacerbations, Ann Allergy Asthma Immunol 2005) Consists of: 1) oxygen saturation on room air 2) accessory muscle use 3) inspiratory to expiratory ratio 4) degree of wheezing 5) heart rate 6) respiratory rate Scored observations 0, 1, 2 or 3. Total score range 0 - 18. Mild exacerbation total less than 6, moderate exacerbation 6 – 10, severe exacerbation higher than 10|Discharge from PICU|Participants with available data||units on a scale||Full Range|Mean
130073|NCT00552448|Secondary|Total Days of Hospital Admission|This is limited due to non collection by collaborating centers.|Days|Data not collected|||||
130074|NCT00552448|Primary|Hours Spent in Pediatric ICU|Length of stay (hours) in Pediatric ICU.|Number of hours from admission to discharge from PICU|||Hours||Standard Deviation|Mean
130075|NCT00552422|Primary|Symptomatic Improvement|The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.|2 months|||participants|||Number
130076|NCT00552409|Primary|Change in Urine Albumin Excretion|Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.|Baseline, 3 months, and one year|All participants were analyzed||percent difference||95% Confidence Interval|Mean
130077|NCT00552396|Secondary|"Number of Evaluable Patients With Stable Disease. Evaluable is Defined as 2 Consecutive M Protein Assessments"|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease|From start of the treatment to end of study or disease progression|||Number of participants|||Number
130078|NCT00552396|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of IPH2101 After Cycle 1 Administration|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Cycle 1.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration|||ng*hours/ml||Geometric Coefficient of Variation|Geometric Mean
130079|NCT00552396|Secondary|Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration|Cmax was obtained from the plasma concentration versus time data after IV administration of IPH2101.|Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
130080|NCT00552396|Primary|Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment|The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.|From start of the treatment to end of study|All treated participants who received at least one dose of the study drug and were evaluable for DLT||Number of participants with DLT|||Number
130081|NCT00552344|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||percentage of subjects|||Number
130082|NCT00552344|Secondary|Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Week 52|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||μg/mL||95% Confidence Interval|Geometric Mean
130083|NCT00552344|Secondary|Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)|IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.||percentage of subjects||95% Confidence Interval|Number
130084|NCT00552344|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Week 262|Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.||percentage of subjects||95% Confidence Interval|Number
130085|NCT00552344|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||percentage of subjects|||Number
130086|NCT00552344|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|From study start to the end of the Safety Follow-up Period (up to 272 weeks)|Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.||percentage of subjects|||Number
130087|NCT00552305|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.||percentage of subjects|||Number
130139|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients||Participants|||Number
130088|NCT00552305|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.~Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, End of Treatment Period (up to 8 years)|Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.||percentage change||Full Range|Median
130089|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
130090|NCT00552305|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
130091|NCT00552305|Primary|Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 8 years)|Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
130092|NCT00552279|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||After the third vaccine dose|||subjects|||Number
130093|NCT00552279|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6~Number of pregnancies and pregnancy outcomes."|During the entire study period (up to Month 18 or Month 12)|Analysis was performed on the Total vaccinated cohort, on pregnant subjects||subjects|||Number
130094|NCT00552279|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)|"Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6.~NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.~An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the entire study period (up to Month 18 or up to Month 12)|||subjects|||Number
130095|NCT00552279|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day (Days 0-29) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
130096|NCT00552279|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
130097|NCT00552279|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||subjects|||Number
130098|NCT00552279|Secondary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as GMT.|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity||EL.U/mL||95% Confidence Interval|Geometric Mean
130099|NCT00552279|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the second vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity||subjects|||Number
130100|NCT00552279|Primary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titer given as geometric mean titer (GMT).|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity||EL.U/mL||95% Confidence Interval|Geometric Mean
130101|NCT00552279|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies."|One month after the third vaccine dose|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity||subjects|||Number
130102|NCT00552240|Secondary|Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities||baseline to week 52|All treated patients||participants|||Number
130103|NCT00552240|Secondary|Proportion of Patients Reporting Rash of Any Severity||baseline to week 52|All treated patients||participants|||Number
130107|NCT00552240|Secondary|Number of Participants With Genotypic Resistance at the Time of Virologic Failure.|Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.|baseline to week 48|Includes only treated patients with data in the specified time window|||||
130108|NCT00552240|Secondary|Percentage Adherence by Pill Count|Number of pills not returned / number of treatment days in percent (%)|baseline to week 48|All treated patients with data||percentage adherence||Standard Deviation|Mean
130109|NCT00552240|Secondary|Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48|using 4-variable Modification of Diet in Renal Disease (MDRD) formula|baseline to week 48|Includes only treated patients with data for the specified time window||ml/min/1.73m^2||Standard Deviation|Mean
130110|NCT00552240|Secondary|Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group||baseline to week 48|Not calculated as no data on family history of cardiovascular disease were available|||||
130111|NCT00552240|Secondary|Change in Framingham Score|Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient’s gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.|baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||percent 10-year risk||Standard Deviation|Mean
130112|NCT00552240|Secondary|Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||ratio||Standard Deviation|Mean
130113|NCT00552240|Secondary|Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||mg/dl||Standard Deviation|Mean
130114|NCT00552240|Secondary|Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||mg/dl||Standard Deviation|Mean
130115|NCT00552240|Secondary|Change in Fasting Plasma Triglycerides Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF)||mg/dl||Standard Deviation|Mean
130116|NCT00552240|Secondary|Change in Fasting Plasma Total Cholesterol Level||baseline to week 48|All treated patients with data, Last observation carried forward (LOCF).||mg/dl||Standard Deviation|Mean
130117|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 48.|Patients on-treatment, data within time windows|baseline to week 48|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130118|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 36.|Patients on-treatment, data within time windows|baseline to week 36|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130119|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 24.|Patients on-treatment, data within time windows|baseline to week 24|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130120|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 12.|Patients on-treatment, data within time windows|baseline to week 12|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130121|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 8.|Patients on-treatment, data within time windows|baseline to week 8|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130122|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 6.|Patients on-treatment, data within time windows|baseline to week 6|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130123|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 4.|Patients on-treatment, data within time windows|baseline to week 4|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130124|NCT00552240|Secondary|Change in CD4+ Cell Count From Baseline to Week 2.|Patients on-treatment, data within time windows|baseline to week 2|Includes only treated patients with data in the specified time window||cells/mm^3||Standard Deviation|Mean
130125|NCT00552240|Secondary|AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death|"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi’s sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.~Number of cases (no time-to analysis was performed due to small numbers)."|baseline to week 48|All treated patients||Participants|||Number
130126|NCT00552240|Secondary|Number of Patients With Virologic Rebound to >400 Copies/ml|HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 48|All treated patients||Participants|||Number
130127|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment|Results within time windows, patients on-treatment|baseline to week 48|All treated patients||Participants|||Number
130128|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment|Results within time windows, patients on-treatment|baseline to week 36|All treated patients||Participants|||Number
130129|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment|Results within time windows, patients on-treatment|baseline to week 24|All treated patients||Participants|||Number
130130|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment|Results within time windows, patients on-treatment|baseline to week 12|All treated patients||Participants|||Number
130131|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment|Results within time windows, patients on-treatment|baseline to week 8|All treated patients||Participants|||Number
130143|NCT00552240|Secondary|Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response|HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)|baseline to week 24 and week 48|All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.||Participants|||Number
130144|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml||baseline to week 48|All responders||days||Inter-Quartile Range|Median
130145|NCT00552240|Secondary|Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants|Time to response whereby patients withdrawing early were censored after their withdrawal|baseline to week 48|All treated patients||days||Inter-Quartile Range|Median
130146|NCT00552240|Secondary|Number of Participants With Virologic Success (FDA Definition)|HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).|baseline to week 48|All treated patients.||Participants|||Number
130147|NCT00552240|Secondary|Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48|HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.|baseline to week 48|Only includes treated patients with data in the Week 48 time window.||Participants|||Number
130148|NCT00552240|Secondary|Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm|HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.||Participants|||Number
130149|NCT00552240|Primary|Number of Participants With Virologic Response (VR)|VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.|baseline to week 48|All treated patients. Early withdrawals were considered failures.||participants|||Number
130150|NCT00552188|Secondary|Change From Baseline in Plaque Imaging After 6 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the TBR from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18FDG uptake measured with PET in patients after 6 weeks of daily dosing.|Baseline and 6 Weeks|Evaluable Population||TBR||95% Confidence Interval|Least Squares Mean
130151|NCT00552188|Primary|Change From Baseline in Plaque Imaging After 24 Weeks|To evaluate the effect of VIA-2291 100 mg relative to placebo on the change from baseline in the target (plaque) to background (blood) ratio (TBR) from an index vessel (either right carotid, left carotid or ascending aorta) based on the standardized 18fluorodeoxy glucose (FDG) uptake measured with PET in patients with acute coronary syndrome and vascular inflammation after 24 weeks of daily dosing.|Baseline and 24 Weeks|Evaluable Population||TBR||95% Confidence Interval|Least Squares Mean
130152|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130153|NCT00552175|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130154|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130155|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130156|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130157|NCT00552175|Secondary|Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)|A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130340|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130158|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130159|NCT00552175|Secondary|Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130160|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 12|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130161|NCT00552175|Secondary|Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130162|NCT00552175|Secondary|Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130163|NCT00552175|Primary|Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)|Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, 12 weeks|Patients in the Full Analysis Set Population who had a post-baseline measurement in the variable being presented.||units on a scale||Standard Error|Least Squares Mean
130164|NCT00552110|Primary|Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score|Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.|from baseline to hour 4 on Day 1|Intention to treat: all randomized subjects who had taken at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
130165|NCT00552110|Primary|Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15|Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.|15 days of treatment|Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug||units on a scale||Standard Error|Least Squares Mean
130166|NCT00552084|Primary|Documented Recurrence of Atrial Fibrillation/Atrial Flutter|Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.|Measured at Week 24 or exit|||percentage of participants|||Number
130167|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose||percentage of subjects||95% Confidence Interval|Number
130168|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130169|NCT00552058|Secondary|Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 93 and 96 subjects are in the 10 mg/L or greater C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130170|NCT00552058|Secondary|Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6|The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 122 and 113 subjects are in the less than 10 mg/L C-reactive Protein (CRP) subgroup at Entry, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130171|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130172|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130173|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 198 and 184 subjects respectively are included in this summary and have assessments at both Weeks 0 and 4. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
130174|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 2|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 204 and 198 subjects respectively are included in this summary and have assessments at both Weeks 0 and 2. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
130175|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 4|The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130176|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 2|The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130177|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 4|The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 4|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130178|NCT00552058|Secondary|Percentage of Subjects in Clinical Remission at Week 2|The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 2|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130179|NCT00552058|Secondary|Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6|The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 196 and 187 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
130180|NCT00552058|Secondary|Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6|The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0 to Week 6|Of the 215 (Certolizumab Pegol 400 mg) and 209 (Placebo) subjects in the Intent-to-treat (ITT) population, 192 and 183 subjects respectively are included in this summary and have assessments at both Weeks 0 and 6. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||score on a scale||Standard Deviation|Mean
130181|NCT00552058|Secondary|Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6|The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130182|NCT00552058|Secondary|Percentage of Subjects Achieving a Clinical Response at Week 6|The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 0, Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130183|NCT00552058|Primary|Percentage of Subjects in Clinical Remission at Week 6|The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.|Week 6|Of the 223 (Certolizumab Pegol 400 mg) and 216 (Placebo) subjects randomized, 215 and 209 subjects are included in the Intent-to-treat (ITT) population, respectively. ITT population: subjects who received at least one dose of study drug, and who had at least one efficacy measurement after first dose.||percentage of subjects||95% Confidence Interval|Number
130184|NCT00552032|Secondary|Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score|"18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126).~Grading was as follows:~Scores < 60 suggest a slight impact on health related quality of life (HRQL)~Scores 60-80 suggest a moderate impact~Scores over 80 suggest a great impact"|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 subjects were included in the ITT population. The ITT population included all randomized participants who received >=1 dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.~1 participant in Placebo group did not answer this questionnaire at baseline."||Score on a scale||Standard Deviation|Mean
130185|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 28 randomized participants were between 8-12 years old, 15 participants in MFNS & 13 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.||Score on a scale||Standard Deviation|Mean
130233|NCT00551213|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to last dose of study drug (Up to approximately 18 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.||Participants|||Number
130186|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 5 and 7 years old, 28 participants in MFNS & 24 subjects in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.||Score on a scale||Standard Deviation|Mean
130187|NCT00552032|Secondary|Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)|The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|The ITT population included all randomized participants who received >= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 2 and 4 years old, 23 participants in MFNS & 29 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.||Score on a scale||Standard Deviation|Mean
130188|NCT00552032|Secondary|Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe|PSQ consists of 90 variables divided into 3 different factors:snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1-3, and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT population. The ITT~population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."||Participants|||Number
130189|NCT00552032|Secondary|Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa|Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3||Standard Deviation|Mean
130190|NCT00552032|Secondary|Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa|"Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.~Measurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) & were reported in cm^3."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3||Standard Deviation|Mean
130191|NCT00552032|Secondary|Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done|Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||Participants|||Number
130192|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3/sec||Standard Deviation|Mean
130193|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||cm^3/sec||Standard Deviation|Mean
130194|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).||Pa/cm^3/sec||Standard Deviation|Mean
130195|NCT00552032|Secondary|Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance|"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)."|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|This analysis was only performed in a cohort of the ITT in participants aged 7-11 years old (MFSN=19, Placebo=20).||Pa/cm^3/sec||Standard Deviation|Mean
130196|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction|Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
130197|NCT00552032|Secondary|Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic|Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
130198|NCT00552032|Secondary|Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation|Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
130199|NCT00552032|Secondary|Number of Participants With Otoscopic Results of: Normal or Abnormal|Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Participants|||Number
130200|NCT00552032|Secondary|Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done|Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|"A total of 132 participants were included in the ITT~population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point."||Participants|||Number
130201|NCT00552032|Secondary|Total Frequency Symptom Scores: AM & PM|Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM & PM (a difference of 12 hours) & were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Score on a scale||Standard Deviation|Mean
130202|NCT00552032|Secondary|Total Severity Symptom Scores: Morning and Evening (AM & PM)|Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM & PM (a difference of 12 hours) & were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.|Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)|A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.||Score on a scale||Standard Deviation|Mean
130267|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)|NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|1 through 48 hours post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations.||score on scale||Standard Error|Least Squares Mean
130203|NCT00552032|Primary|Change From Baseline in Adenoid/Choana (A/C) Index Grade|Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.|Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)|A total of 132 participants were included in the intent-to-treat (ITT) population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data are summarized in terms of the number of participants providing data at the relevant time point.||Score on a Scale||Standard Deviation|Mean
130204|NCT00551759|Primary|Proportion of Patients With Pathologic Complete Response|After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.|At time of surgery (which occurred 63 to 91 days after study entry)|Eligible and treated patients||Proportion of patients||90% Confidence Interval|Number
130205|NCT00551746|Secondary|The Impact of Polymorphism in Haemostatic Genes on Variation in Platelet Function Among Participants Based on Long-term PGJ Consumption.||90-days||||||
130206|NCT00551746|Secondary|Compare Platelet Inhibitory Pathways of ADP,TRAP, PMA, Arachadonic Acid Between PGJ and Placebo.|The platelet inhibitory pathway in which PGJ functions by performing platelet aggregation tests using agonists for the 4 major platelet activation pathways: ADP,thrombin receptor-activator peptide (TRAP), phorbol 12-myristate 13-acetate (PMA), arachadonic acid(10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days||||||
130207|NCT00551746|Primary|Compare Change in Platelet Aggregation as Measured by Adenosine Diphosphate (ADP) Between PGJ and Placebo|Platelet aggregation was measured using the agonist ADP (10 microM) in a light transmission aggregometer and compared between PGJ and placebo via the intent-to-treat paradigm.|90-days|The number of participants evaluated were those who had both a baseline and visit 4 platelet aggregation and platelet-dependant inflammatory marker values||percent||Standard Deviation|Mean
130208|NCT00551707|Secondary|To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to 98 Days||||||
130209|NCT00551707|Primary|Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|Day 98|As treated population||mg/L||Full Range|Median
130210|NCT00551707|Secondary|To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98||||||
130211|NCT00551707|Secondary|Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population|Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.|baseline to day 98|As treated population||percentage of change from baseline||Full Range|Median
130212|NCT00551642|Secondary|Methemoglobin Level||Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment||||||
130213|NCT00551642|Secondary|Adverse Events||Study Duration||||||
130214|NCT00551642|Secondary|Arterial Oxygen Saturation by Pulse Oximetry||Study Duration||||||
130215|NCT00551642|Secondary|Vital Signs||Study Duration||||||
130216|NCT00551642|Primary|Survival||36 Weeks GA||||||
130217|NCT00551642|Primary|Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress|The primary outcome was determined by assessment of survival and incidence of BPD,which was defined by the need for supplemental oxygen at 36 weeks gestational age (GA); an infant who was alive without BPD at 36 weeks GA was counted as success; an infant who died or had BPD at 36 weeks GA was counted as a failure.|36 weeks gestational age|||participants alive without BPD|||Number
130218|NCT00551421|Secondary|Overall Survival|The duration of time from start of study treatment to death from any cause.|The duration of time from start of study treatment to death from any cause.|||months||95% Confidence Interval|Median
130219|NCT00551421|Secondary|Progression-free Survival|The duration of time from start of study treatment to time of objective disease progression or death.|The duration of time from start of study treatment to time of objective disease progression or death.|||months||95% Confidence Interval|Median
130220|NCT00551421|Primary|Objective Tumor Response Rate Defined as the Proportion of Patients With a Best Overall Response of CR or PR, Per RECIST Criteria (Phase II)|Objective tumor response rate defined as the proportion of patients with a best overall response of CR or PR, per RECIST criteria (Phase II).|Best tumor response from time period of start of study treatment to study discontinuation.|||percentage of patients|||Number
130221|NCT00551421|Primary|Recommended Phase II Dose of Pertuzumab When Administered in Combination With Cetuximab (Phase I)|The regimen was deemed intolerable so there was no recommended phase II dose.|28 days||||||Number
130222|NCT00551369|Secondary|Prediction of Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2||From start of treatment to 2 years.||||||
130223|NCT00551369|Secondary|Level of Comorbidity Burden on Morbidity and Efficacy||From start of treatment to end of follow-up.||||||
130322|NCT00550654|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|9 months, 11 days|||Participants|||Number
130224|NCT00551369|Secondary|Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years|PTF: the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure) within the first two years after start of SBRT. RF: the development of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum within the first two years after start of SBRT. MD: the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer within the first two years after start of SBRT. DFS: the state of being alive without development of progressive disease, with failure considered the earliest development of either progression or death. OS: the state of being alive, with failure is considered death due to any cause.|From start of treatment to 2 years.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
130225|NCT00551369|Secondary|Other Grade 3-5 Adverse Events|The development of any treatment-related toxicity not from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
130226|NCT00551369|Secondary|Rate of Treatment-related Grade 3 or 4 Toxicity|The development of any treatment-related toxicity from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy|From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
130227|NCT00551369|Primary|Primary Tumor Control at 2 Years|Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.|From start of treatment to 2 years.|All eligible patients who started study treatment||percentage of patients||95% Confidence Interval|Number
130228|NCT00551291|Secondary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|Up to approximately 2 years|||percentage of participants|||Number
130229|NCT00551291|Primary|Mean Number of Blood Transfusions Per Visit||Up to approximately 2 years|||transfusions/visit||Standard Deviation|Mean
130230|NCT00551291|Primary|Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement|International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.|Up to approximately 2 years|||percentage of participants|||Number
130231|NCT00551213|Secondary|Change From Baseline in Tumor Growth Rate|Tumor growth rate was assessed by CT or MRI scans using RECIST criteria at Screening, at every 8 weeks of robatumumab treatment and at post study. For Pre Baseline 1, tumor growth rate=(sum of longest diameter of target lesions at Baseline – the most recent prior to Baseline)/duration between Baseline and Pre Baseline. For all other cycles, tumor growth rate=(sum of longest diameter of target lesions at a cycle – Baseline)/ duration between Baseline and the cycle. The cycles presented below are relative to the first dose of robatumumab in Period 1.|Baseline and up to approximately 22 weeks|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.||mm/day||Standard Deviation|Mean
130232|NCT00551213|Secondary|Best Overall Tumor Response Per Central Review|Tumor response was assessed by CT or MRI scan using RECIST v1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the LD for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.||Participants|||Number
130339|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment|Incidence of potentially clinically significant ECG abnormalities: ST Segment|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130234|NCT00551213|Secondary|Best Overall Tumor Response Per Investigator Review|Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST v 1.0 criteria at Screening, at every 8 weeks of robatumumab treatment during Period 2 and at post study. A sum of the longest diameter (LD) for all target lesions was calculated and reported as the baseline sum LD. Overall tumor responses were defined as: Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of robatumumab were included in the analysis.||Participants|||Number
130235|NCT00551213|Secondary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 30 days after last dose of study drug (Up to approximately 22 weeks)|All participants who received ≥1 dose of study drug were included in the analysis.||Participants|||Number
130236|NCT00551213|Primary|Number of Participants With a >20% Decrease in Positron Emission Tomography (PET)-Assessed Tumor Glucose Metabolism: Fluorodeoxyglucose (FDG) Standardized Uptake Value (SUV) in the Target Lesion|FDG-PET was used in this study to detect the biological activity of modulation of the target within the tumor. Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 was used to select the target lesion. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were identified as target lesions and recorded and measured at Baseline. The changes in SUVmax were calculated using the formula: (endpoint SUVmax – baseline SUVmax)/baseline SUVmax as a percentage. If multiple lesions had been measured at a visit, percentages calculated for all target lesions were averaged to find the decrease during the treatment period per participant. FDG SUVmax responder was defined as participants with >20% decrease in SUVmax after the first cycle of robatumumab in Period 2.|After the first robatumumab dose in Period 2 (Up to approximately 4 weeks after first robatumumab dose in Period 1)|All participants who received ≥1 dose of robatumumab in Periods 1 and 2 and had SUV data before and after the first dose of robatumumab in Period 2 were included in the analysis. No participants in the Chemotherapy→Robatumumab group received robatumumab in Period 1.||Participants|||Number
130237|NCT00551200|Primary|Number of Subjects Experienced Serious Adverse Events||during the period subjects on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)|||participants|||Number
130238|NCT00551200|Primary|Number of Subjects Experienced Adverse Events||during the period on 100% Buphenyl (up to 4 weeks) or HPN-100 (up to 10 weeks)|||participants|||Number
130239|NCT00551200|Secondary|Drug Preference for HPN-100 or Buphenyl® (as Assessed by Global Preference Question)||End of Study|||participants|||Number
130240|NCT00551200|Primary|Venous Ammonia Levels at the Peak and Mean TNUAC Time-normalized Area Under the Curve)|Data were collected at pre-first dose and at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone), and at steady state (1 week) after each dose escalation|||μmol/L|concentration of ammonia|Standard Deviation|Mean
130241|NCT00551200|Secondary|Pharmacokinetics (Plasma and Urine PK Parameters of Study Drugs and Their Metabolites)|measured AUC0-24 (Area under the curve from time 0 (pre-dose) to 24 hours) for each metabolite in plasma. Data were collected at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post-first dose.|At steady state (1 week) on each medication (Buphenyl® alone, HPN-100 alone)|||μg*h/mL|plasma|Standard Deviation|Mean
130242|NCT00551174|Secondary|Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months|Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6 months|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 89, 2 mg group: 93.||Percent change||Standard Deviation|Mean
130243|NCT00551174|Secondary|Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months|Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)|Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 87, 2 mg group: 92; Month 12: 3 mg group = 92, 2 mg group = 92; Month 24: 3 mg group = 83, 2 mg group = 85; Month 36: 3 mg group = 75, 2 mg group = 76.||Percent change||Standard Deviation|Mean
130244|NCT00551174|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months|Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT populations: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 381, 2 mg group = 347; Month 24: 3 mg group = 371, 2 mg group = 330; Month 36: 3 mg group = 349, 2 mg group = 314.||Percent change||Standard Deviation|Mean
130266|NCT00551135|Secondary|Numeric Rating Scale (NRS): Average Pain|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
130245|NCT00551174|Primary|Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months|Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.|Baseline,12, 24 and 36 months|ITT population: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 383, 2 mg group = 348; Month 24: 3 mg group = 374, 2 mg group = 332; Month 36: 3 mg group = 349, 2 mg group = 314.||Percent change||Standard Deviation|Mean
130246|NCT00551161|Primary|Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor|Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 [(t2 – t1) – (t1 – t0)].|Baseline, 24 weeks, and 48 weeks|Per protocol||ratio (normalized to T2-corrected water||Standard Deviation|Mean
130247|NCT00551135|Secondary|Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)|NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 [no pain] to 10 [worst pain imaginable]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.||scores on a scale||Standard Deviation|Mean
130248|NCT00551135|Secondary|Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory–Short Form (mBPI-sf)|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.||scores on a scale||Standard Deviation|Mean
130249|NCT00551135|Secondary|Participants With Chronic Postoperative Pain|"Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: In the last 24 hours, have you had pain in the area affected by your surgery?)"|1, 3, and 6 months (mo) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||participants|||Number
130250|NCT00551135|Secondary|Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS)|PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.||scores on a scale||Standard Error|Least Squares Mean
130251|NCT00551135|Secondary|Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all items (range: 0 to 52); higher scores mean a greater extent of pain catastrophizing.|Baseline and Days 1 and 7 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.||scores on a scale||Standard Error|Least Squares Mean
130252|NCT00551135|Secondary|Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales|The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.|3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
130253|NCT00551135|Secondary|Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.|Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.||scores on scales||Standard Error|Least Squares Mean
130546|NCT00549393|Primary|Bacteremia|incidence of bacteremia comparing those in treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days|Intent to treat population||events per 1000 at-risk days||95% Confidence Interval|Number
130254|NCT00551135|Secondary|Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score|Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject’s mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
130255|NCT00551135|Secondary|Participants With Physician Contacts Post-discharge|"Number of participants who answered yes to the Post-Surgery Contact question: From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"|24 and 72 hours (h) post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations||participants|||Number
130256|NCT00551135|Secondary|Participants With Wound Healing Complications|Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.|Day 7 post surgery (PS) and up to 30 days PS|Operated subjects within the safety population. Safety population=all randomized subjects administered at least 1 dose of study drug and for whom at least 1 post-baseline safety evaluation was obtained.||participants|||Number
130257|NCT00551135|Secondary|Subject Global Evaluation of Study Medication (GESM)|GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.|24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations||participants|||Number
130258|NCT00551135|Secondary|Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr).|3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations.||participants|||Number
130259|NCT00551135|Secondary|Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)|OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 [none] to 10 [10 CMEs]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 [none] to 9 [9 CMEs]).|3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
130260|NCT00551135|Secondary|Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study|Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.|End of Surgery through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. Amount of antiemetic rescue medications not analyzed as planned.||mg||Standard Error|Least Squares Mean
130261|NCT00551135|Secondary|Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery|Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.|24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). During surgery data not analyzed as planned.||mg||Standard Error|Least Squares Mean
130262|NCT00551135|Secondary|Daily Sleep Interference Rating Scale (DSIRS) Score|DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.|Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on a scale||Standard Error|Least Squares Mean
130263|NCT00551135|Secondary|Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)||Day 1|MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.||hours||Standard Error|Least Squares Mean
130264|NCT00551135|Secondary|Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)|PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.|Day 1|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.||hours||Standard Error|Least Squares Mean
130265|NCT00551135|Secondary|Time From End of Surgery to First Rescue Medication|Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.|Day 1 through Day 7 post surgery|MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.||hours||Standard Error|Least Squares Mean
131493|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Participants|||Number
130268|NCT00551135|Secondary|Numerical Rating Scale (NRS): Current Pain at Rest|NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).|2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
130269|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing|NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).|1 hour through 48 hours post surgery|MITT; 1 site excluded for GCP deviations; n=subjects with analyzable data at observation (pregabalin 50, 150, and 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
130270|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Coughing|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
130271|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Walking|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
130272|NCT00551135|Secondary|Numeric Rating Scale (NRS): Current Pain With Movement - Sitting|NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).|Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])|MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).||scores on scale||Standard Error|Least Squares Mean
130273|NCT00551135|Primary|Modified Brief Pain Inventory–Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery|m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).|24 hours post surgery|Modified Intent-to-Treat Population (MITT): all subjects included in intent-to-treat population who took study medication 12 and 2 hours prior to surgery, had no complications during herniorrhaphy, and had the post-surgery primary efficacy measurement. Data from 1 site excluded due to Good Clinical Practices (GCP) deviations.||scores on scale||Standard Error|Least Squares Mean
130274|NCT00551070|Secondary|Overall Survival||Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years|Eligible and Treated Patients||Months||95% Confidence Interval|Median
130275|NCT00551070|Primary|Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available||ng/mL||Inter-Quartile Range|Median
130276|NCT00551070|Primary|Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.||Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment|Eligible and Treated Patients with all pharmacokinetic time points available||ng x hr/mL||Inter-Quartile Range|Median
130277|NCT00551070|Primary|Adverse Events (Grade 3 or Higher) During First Cycle of Treatment||Cycle 1|Eligible and treated patients.||percentage of patients||95% Confidence Interval|Number
130278|NCT00551070|Secondary|Number of Courses Received||Every cycle|Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.||courses||Inter-Quartile Range|Median
130279|NCT00551070|Secondary|Progression-free Survival||Every other cycle|Eligible and Treated Patients||months||95% Confidence Interval|Median
130280|NCT00551070|Primary|Tumor Response|Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0|Every other cycle|Eligible and treated patients||percentage of patients||90% Confidence Interval|Number
130281|NCT00551031|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|"Solicited injection site reactions: Pain, Pruritus, Erythema, Swelling, Induration, and Ecchymosis.~Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Chills"|Days 0 through 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent to treat population.||Participants|||Number
130282|NCT00551031|Primary|Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.||Percentage of Participants|||Number
130283|NCT00551031|Primary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine|Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per protocol population.||Percentage of Participants|||Number
131494|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population||Week 104|ITT Population.||Participants|||Number
130284|NCT00551031|Primary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.|Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post vaccination|Serum antibody titers GMTs were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
130285|NCT00550953|Secondary|Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG|Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of randomised treatment to 24 hours post last dose of randomised treatment|Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or T40 during the double-blind treatment period.||participants|||Number
130286|NCT00550953|Secondary|Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline)|"Optimal, normal, high normal blood pressure were defined as follows:~Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg~Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg~High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg"|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
130287|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
130288|NCT00550953|Secondary|Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline)|Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
130289|NCT00550953|Secondary|Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
130290|NCT00550953|Secondary|Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline)|Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake|8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||percentage of participants|||Number
130291|NCT00550953|Secondary|Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
130292|NCT00550953|Primary|Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks|The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.|Baseline and 8 Weeks|Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose.||mmHg||Standard Error|Mean
130293|NCT00550862|Secondary|Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites||12 Weeks||||||
130294|NCT00550862|Secondary|Alanine Aminotransferase (ALT)|Mean percent change in serum alanine aminotransferase (ALT) from baseline to Day 85/early termination.|Baseline and 12 weeks|||Percent (%) change||Standard Deviation|Mean
130295|NCT00550862|Secondary|Serum Gamma-Glutamyl Transpeptidase (GGT)|Percent change in serum gamma-glutamyl transpeptidase (GGT) from baseline to Day 85/early termination.|Baseline and 12 weeks|||Percent (%) change||Standard Deviation|Mean
130296|NCT00550862|Primary|Alkaline Phosphatase (ALP).|The primary efficacy endpoint was the relative (%) change in plasma ALP from pretreatment values. The prestudy consensus opinion of the investigators was that a placebo-substracted ALP fall of ≥ 10% would be clinically significant.|Baseline and 12 weeks|||Percent (%) change||Standard Deviation|Mean
130297|NCT00550771|Secondary|Number of Participants Who Survived Without Relapse|"Relapse-free survival would have been determined by Kaplan-Meier method.~This was not calculated, since the 2 year follow-up was curtailed."|Approximately 2 years||||||
130298|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During 1 year of trastuzumab therapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.||Participants|||Number
130299|NCT00550771|Secondary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|During the 8 courses of chemotherapy|ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.||Participants|||Number
130300|NCT00550771|Primary|Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year|"Cardiac events defined as:~Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF~Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks."|8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment|"ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.~Each participant could not contribute more than 1 event."||Participants|||Number
130301|NCT00550745|Secondary|Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination|"Only Serious Adverse Events were collected and analyzed for this study.~A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|6 months|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 182 day reporting period. The date of death may have occurred after 182 days."||Participants|||Number
130302|NCT00550745|Primary|Serious Adverse Events Reported Within 42 Days Postvaccination|"Only Serious Adverse Events were collected and analyzed for this~study.~A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|42 Days|"All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 42 day reporting period. The date of death may have occurred after 42 days."||Participants|||Number
130303|NCT00550732|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 12 months|All enrolled participants who received at least one dose of study medication.||Number of participants|||Number
130304|NCT00550732|Secondary|Number of Participants With Response to Posaconazole in Combination Therapy|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The proportion of participants with response to posaconzole who received a prior combination antifungal regimen is not reported as per recommendation from the Safety and Steering Committee since only 1 participant was evaluable for this outcome measure.|||||
130305|NCT00550732|Secondary|Overall Survival at 3 Months|Total number of participant survivors was assessed at 3 months.|3 months|All enrolled participants||Percentage of Participants|||Number
130306|NCT00550732|Secondary|Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug|Infection-free survival was the proportion of evaluable participants included in the efficacy analysis who are infection-free and alive at 6 months post last dose visit. Infection-free is defined as the resolution of signs and symptoms of infection.|Up to 6 months|The Efficacy Population included those participants with a visit 6 months after the last dose.||Percentage of participants|||Number
130307|NCT00550732|Secondary|Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 26 weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.||Percentage of Participants|||Number
130308|NCT00550732|Secondary|Percentage of Participants With a CR or PR by 12 Weeks|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 12 Weeks|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.||Percentage of participants|||Number
130309|NCT00550732|Secondary|Number of Participants With ≥50% Decrease in Lesion Size or Number|Reduction in lesion size was analyzed by computed tomography (CT) scan. An imaging response was defined as >=50% reduction in lesion size for pulmonary and cerebral disease or >=50% reduction in the number of lesions for liver disease.|Up to 6 months|This outcome measure was not reported as the Safety and Steering Committee (SSC) no longer considered it relevant based on revised Mycoses Study Group and European Organization for Research and Treatment of Cancer (MSG/EORTC) Consensus Criteria.|||||
131495|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Participants|||Number
130310|NCT00550732|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment|Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.|Up to 6 months|The Efficacy Population included those participants with both a baseline and at least 1 post-baseline assessment.||Percentage of participants|||Number
130311|NCT00550680|Secondary|Number of Participants Prematurely Withdrawn From the Study to Receive Blood Transfusion|The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported.|Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24|All Enrolled Population: Includes all participants enrolled into the study regardless of treatment received.||participants|||Number
130312|NCT00550680|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the Dose Titration Period (DTP) and EEP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 17 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; number (n) of participants who entered each treatment period was reported.||percentage of participants|||Number
130313|NCT00550680|Secondary|Mean Time Spent in the Target Range for Hb During the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population||days||Standard Deviation|Mean
130314|NCT00550680|Secondary|Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP|During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.5 to 12.5 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) during Weeks 18, 20, 22, and 24|ITT Population||percentage of participants||95% Confidence Interval|Number
130315|NCT00550680|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Intent-to-Treat (ITT) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment.||g/dL||Standard Deviation|Mean
130316|NCT00550680|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.5 to 12.5 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24|Per Protocol (PP) Population: All participants who received at least one dose of Mircera/CERA and provided data for at least one follow-up assessment, and who fulfilled inclusion/exclusion criteria per study protocol.||percentage of participants||95% Confidence Interval|Number
130317|NCT00550654|Secondary|Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy|Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.|Baseline and prior to termination of systemic therapy or protocol withdrawal|No data/specimens were collected. Study was terminated due to poor accrual.|||||
130318|NCT00550654|Secondary|Pain at Sites of Metastases|Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.|One and three months of follow up|No data/specimens were collected. Study was terminated due to poor accrual.|||||
130319|NCT00550654|Secondary|Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis|Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.|One to three months of followup|No data/specimens were collected. Study was terminated due to poor accrual.|||||
130320|NCT00550654|Secondary|12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion.|12 months|No data/specimens were collected. Study was terminated due to poor accrual.|||||
130321|NCT00550654|Secondary|Median Time to Local Progression|Interval from initiation of treatment on protocol to symptomatic or radiographic progression.|6-12 months|No data/specimens were collected. Study was terminated due to poor accrual.|||||
130323|NCT00550654|Primary|6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease|Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.|6 months|No data/specimens were collected. Study was terminated due to poor accrual.|||||
130324|NCT00550589|Secondary|Changes in Gene Expression in Perianal HSIL After Exposure to Cidofovir as Assessed by RNA Microarray Analysis||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene expression analysis was not done|||||
130325|NCT00550589|Secondary|Distribution of Abnormally Methylated Genes Among HSIL, Low-grade Squamous Intraepithelial Lesions, and Normal Perianal Skin||Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The gene analysis was not done|||||
130326|NCT00550589|Secondary|Identification of Abnormally Methylated Genes in Perianal Dysplasia|Identification of abnormally methylated genes in perianal dysplasia|Baseline, after cycle 1, and 6 weeks after treatment discontinuation|The lab analysis of genes was not performed|||||
130327|NCT00550589|Secondary|Identification of HPV-DNA Types Present in the Anus|Number of patients with HPV16 type present in the anus from anal swab or cytobrush at baseline|Baseline|Number of patients with anal swabs or cytobrush results at baseline||participants|||Number
130328|NCT00550589|Secondary|Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA|Number of patients who cleared HPV among those who had a complete or partial response|6 weeks after treatment discontinuation|Participants who had a partial or complete response and for whom pre and post-treatment HPV data were available||participants|||Number
130329|NCT00550589|Secondary|Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue|Number of patients with HPV16 at baseline in perianal HSIL and normal perianal tissue|Baseline|Number of patients with tissue samples available at baseline||participants|||Number
130330|NCT00550589|Primary|Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0|Number of study patients who had a serious adverse event|Every 2 weeks on study, 6 weeks after treatment discontinuation|All enrolled patients||participants|||Number
130331|NCT00550589|Primary|Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL)||6 weeks after treatment discontinuation|||proportion of participants|||Number
130332|NCT00550550|Secondary|Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS|The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry for the rhinoconjunctivitis quality-of-life measure.||Units on a Scale||Standard Error|Mean
130333|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS|The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication.|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
130334|NCT00550550|Secondary|Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS|The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst).|Start of the GPS to the End of the GPS|The FAS population was comprised of all participants with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
130335|NCT00550550|Primary|Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)|The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication.|From the Start of the GPS to the End of the GPS|The Full Analysis Set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.||Units on a Scale||Standard Error|Mean
130336|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia|Incidence of potentially clinically significant ECG abnormalities: arrhythmia|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130337|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)|Incidence of potentially clinically significant ECG abnormalities: Right bundle branch block (RBBB), Left bundle branch block (LBBB), myocardial infarction (MI)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130338|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave|Incidence of potentially clinically significant ECG abnormalities: T wave|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130341|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec|Incidence of potentially clinically significant ECG abnormalities (QTcB increase 30-60 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130342|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval|Incidence of potentially clinically significant ECG abnormalities involving QRS interval (change > 100 msec)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130343|NCT00550459|Secondary|Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)|Incidence of potentially clinically significant ECG abnormalities (QT>500 msec) post-baseline|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130344|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium|Incidence of potentially clinically significant magnesium levels post-baseline (normal range=1.2-2 mEq/L)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130345|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose|Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130346|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol|Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130347|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid|Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130348|NCT00550459|Secondary|Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)|Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130349|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Neutrophils|Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8 thousands/microliter)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130350|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes|Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130351|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)|Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130352|NCT00550459|Secondary|Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin|Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8 g/dL)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130353|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Temperature|Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of >=1.1 to >=38.3 degrees Celsius)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130354|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Body Weight|Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of >=7%)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130355|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Pulse Rate|Incidence of abnormal pulse rate post-baseline [abnormal values: >=120 beats per minute (bpm) + increase of >=15 bpm; <=50 bpm + decrease of >=15 bpm]|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130356|NCT00550459|Secondary|Number of Patients With Vital Sign Abnormalities: Blood Pressure|Incidence of abnormal systolic & diastolic blood pressure values post-baseline (abnormal systolic values: >=180 mmHg + increase of >=20 mmHg, <= 90 mmHg + decrease >=20 mmHg; abnormal diastolic values: >=105 mmHg+increase of >=15 mmHg, <=50 mmHg + decrease of >= 15 mmHg)|28 days|Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication||participants|||Number
130357|NCT00550459|Secondary|Change From Baseline in Serum Sodium; ITT Population|Change from Baseline to Day 22 in Serum Sodium; ITT population|Baseline and Day 22|ITT population with OC||mEq/L||Standard Deviation|Mean
130358|NCT00550459|Secondary|Change From Baseline in Postural Stability Test|Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population|baseline and Day 22|ITT population with LOCF (this group includes missing values)||Z-score||Standard Deviation|Mean
130359|NCT00550459|Secondary|Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)|Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population|baseline and Day 22|ITT population with OC||Seconds||Standard Deviation|Mean
130360|NCT00550459|Secondary|Change From Baseline in Overall Neurocognitive Composite Score|Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
130361|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
130362|NCT00550459|Secondary|Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test|Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
130363|NCT00550459|Secondary|Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests|Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population|baseline and Day 22|ITT population with OC||Z-score||Standard Deviation|Mean
130364|NCT00550459|Primary|Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)|"Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize yes 50 times;Choice=recognize yes or no 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right & left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data"|baseline and Day 22|Analysis based upon observed cases (OC).||Z-score||Standard Deviation|Mean
130365|NCT00550446|Other Pre-specified|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130366|NCT00550446|Other Pre-specified|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130367|NCT00550446|Other Pre-specified|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130368|NCT00550446|Other Pre-specified|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
131496|NCT00541658|Secondary|Number of Patients With at Least One New Fractured Vertebra, Week 52||Week 52|ITT Population||Participants|||Number
130369|NCT00550446|Other Pre-specified|Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24|The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||cells/mcL||Standard Deviation|Mean
130370|NCT00550446|Other Pre-specified|Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers|The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||cells per micro liter (cells/mcL)||Standard Deviation|Mean
130371|NCT00550446|Other Pre-specified|Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||mg/dL||Standard Deviation|Mean
130372|NCT00550446|Other Pre-specified|Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels|Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.|Baseline, Week 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
130373|NCT00550446|Secondary|Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130374|NCT00550446|Secondary|Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130375|NCT00550446|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130376|NCT00550446|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130377|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
130854|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||umol/L||Standard Deviation|Mean
130378|NCT00550446|Secondary|Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)|CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
130379|NCT00550446|Secondary|Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)|Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
130380|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR [mm/hour] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130381|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130382|NCT00550446|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130383|NCT00550446|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130384|NCT00550446|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130385|NCT00550446|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
130386|NCT00550446|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
130387|NCT00550446|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
130388|NCT00550446|Secondary|Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
130389|NCT00550446|Secondary|Physician Global Assessment (PGA) of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
130390|NCT00550446|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
130391|NCT00550446|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
130392|NCT00550446|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
130393|NCT00550446|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Deviation|Mean
130394|NCT00550446|Secondary|Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
130395|NCT00550446|Secondary|Swollen Joint Counts (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Deviation|Mean
130405|NCT00550407|Post-Hoc|Number of Participants With Intervention for Depressive Episode|The number of participants with intervention for depressive episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for depressive episode (TIDep). Data from participants who had not met TIDep were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
131506|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
130396|NCT00550446|Secondary|Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
130397|NCT00550446|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Deviation|Mean
130398|NCT00550446|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 10, 12|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. Missing values were imputed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
130399|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: >= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.||percentage of participants|||Number
130400|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group respectively.||percentage of participants|||Number
130401|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
130402|NCT00550446|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: 20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
130403|NCT00550446|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 % improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. The analysis used Baseline Observation Carried Forward (BOCF) imputation for missing values.||percentage of participants|||Number
130404|NCT00550407|Post-Hoc|Number of Participants With Intervention for a Manic, Hypomanic, or Mixed Episode|The number of participants with intervention for a manic, hypomanic, or mixed episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Placebo or Lamotrigine groups regarding time to intervention for manic, hypomanic, or mixed episode (TIMan). Data from participants who had not met TIMan were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
130432|NCT00547638|Secondary|Cosmesis|The evaluation of healing and cosmetic outcome post-treatment using the modified Hollander Cosmesis Scale (mHCS). The proportion of patients with a zero (0) score will be compared between the test and control arms.|30 days (±5 days)|Intent to Treat Population where good outcome for overall appearance. A p-value of 0.457 was determined following comparison by Fisher's Exact Test.||Participants|||Number
130406|NCT00550407|Post-Hoc|Number of Participants With Intervention for Any Mood Episode|The number of participants with intervention for any mood episode was measured. The necessity of the intervention was determined by the Investigator’s discretion. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to intervention for any mood episode (TIME). See the outcome measure for TIME for data for the Placebo group. Data from participants who had not met TIME were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
130407|NCT00550407|Post-Hoc|Number of Participants With a Withdrawal Event|The number of participants who withdrew from the study was measured. This outcome measure was added post-hoc because no data are being reported for the Lamotrigine group regarding time to study withdrawal. See the primary outcome measure for time to study withdrawal data for the Placebo group. Data from participants who had not withdrawn were defined as censored.|Randomization to Study Withdrawal (up to Week 26)|FAS2||participants|||Number
130408|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.||points on a scale||Standard Deviation|Mean
130409|NCT00550407|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)|The YMRS is an 11-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-8 and 0-4, with the total YMRS score ranging from 0 (not ill) to 60 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
130410|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the HAMD-17 at Week 16/Withdrawal.||points on a scale||Standard Deviation|Mean
130411|NCT00550407|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)|The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
130412|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 16/Withdrawal value minus the baseline value (at Week 0 of the Preliminary Phase).|Baseline and Week 16/Withdrawal|FAS1. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-S at Week 16/Withdrawal.||points on a scale||Standard Deviation|Mean
130413|NCT00550407|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)|The CGI-S is a 7-point scale that assessed the participant's severity of illness based on the total clinical experience of the Investigator with this particular population; 0=not assessed, 1= normal, not at all ill to 7= among the most extremely ill participants. Change from baseline was calculated as the Week 26/Withdrawal value minus the baseline value (at the time of randomization).|Baseline and Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
130414|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 16/Withdrawal|Full Analysis Set in the Preliminary Phase (FAS1): all participants who received at least one dose of study medication for the Preliminary Phase and underwent at least one efficacy assessment after receiving the study medication in the Preliminary Phase. Nine participants in the Lamotrigine 25-200 mg group have no data for the CGI-I.||points on a scale||Standard Deviation|Mean
130415|NCT00550407|Secondary|Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)|The CGI-I is a 7-point scale that assessed the participant's global improvement compared to his/her condition at study entry whether or not, in the judgement of the Investigator, it was due entirely to drug treatment; 0=not assessed, 1= very much improved to 7= very much worse.|Week 26/Withdrawal|FAS2||points on a scale||Standard Deviation|Mean
130416|NCT00550407|Secondary|Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)|"The TIMan was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of the relapse or recurrence of a manic, hypomanic, or mixed episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for a Manic, Hypomanic, or Mixed Episode for data related to TIMan."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In both groups, the estimated median TIMan was not calculable because the probability of not reaching TIMan remained greater than 0.50 throughout the study.|||||
130477|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
130417|NCT00550407|Secondary|Time to Intervention for Depressive Episode (TIDep)|"The TIDep was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or ECT determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression episode. No data are being presented for either treatment group. See the outcome measure entitled Number of Participants with Intervention for Depressive Episode for data related to TIDep."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIDep was not calculable because the probability of not reaching TIDep remained greater than 0.50 throughout the study. The upper limit of the confidence interval was not calculable for the Placebo group due to an insufficient number of events.|||||
130418|NCT00550407|Secondary|Time to Intervention for Any Mood Episode (TIME)|"The TIME was defined as the time from entry into the Randomized Phase to the time of the first prescription of any additional pharmacotherapy or electroconvulsive therapy (ECT) determined by the Investigator to be necessary for treatment of a relapse or recurrence of depression or the recurrence of a manic, hypomanic, or mixed episode, whichever occurred first. Categorization as a manic, hypomanic, or mixed episode was left to the Investigator's discretion. See the outcome measure entitled Number of Participants with Intervention for Any Mood Episode for data related to TIME."|Randomization to Study Withdrawal (up to Week 26)|FAS2. In the Lamotrigine 200 mg group, the estimated median TIME was not calculable because the probability of not reaching TIME remained greater than 0.50 throughout the study.||days||95% Confidence Interval|Median
130419|NCT00550407|Primary|Time to Withdrawal From Study|"The time from randomization to the time at which the participant was withdrawn from the Double-Blind Phase of the study for any reason was measured. No data are reported for the Lamotrigine group because of an incalculable confidence interval. See the outcome measure entitled Number of Participants with a Withdrawal Event for data regarding the number of participants who withdrew from the study."|Randomization to Study Withdrawal (up to Week 26)|Full Analysis Set in Randomized (double-blind) Phase (FAS2): participants who received at least one dose of study medication in the Randomized Phase (RP) and had at least one post-treatment efficacy assessment in the RP. The upper limit of the confidence interval was not calculable for the Lamotrigine group due to an insufficient number of events.||days||95% Confidence Interval|Median
130420|NCT00550368|Secondary|Intensity of Gastrointestinal Symptoms|Composite gastrointestinal symptom score was on a scale from 0 (no symptoms) to 15 (severe symptoms). This composite was the sum of 5 self-reported, symptom scores, each ranging from 0 (none) to 3 (severe). The self-reported symptoms that subjects scored were: malaise, headache, nausea, vomiting, and loose stool.|48 hours|||units on a scale||Full Range|Median
130421|NCT00550368|Primary|Development of Diarrhea||48 hours|||participants|||Number
130422|NCT00550277|Secondary|Overall Response||18 months||||||
130423|NCT00550277|Secondary|To Evaluate the Toxicity of LBH589 in Patients With Refractory Advanced Clear Cell Renal Carcinoma||18 months||||||
130424|NCT00550277|Primary|To Evaluate the Efficacy of LBH589 in the Treatment of Patients With Refractory Clear Cell Carcinoma, as Measured by Progression-free Survival||18 months|||months||95% Confidence Interval|Median
130425|NCT00547703|Secondary|Side Effects|To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia. Patients were asked about side effects on each office visit and ask to call for significant side effects.|8 weeks||||||
130426|NCT00547703|Secondary|QOLRAD Questionaire for Patients With Upper Abdominal Symptoms|Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia|8 weeks||||||
130427|NCT00547703|Primary|Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.|Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes.|8 weeks|All patients who completed the 8 weeks of the study||participants|||Number
130428|NCT00547638|Other Pre-specified|Incidence of Any Other Anticipated or Unanticipated Adverse Events|Adverse events were coded using the MedDRA dictionary. In addition severity, relationship to treatment and procedure, action taken and outcome were described. Adverse events were summarized by treatment group. No formal statistical analysis was performed on overall incidence of adverse events with the exception of clinical infection, acute inflammatory reactions and skin blistering.|Day 30|Intent to treat population in which subjects experiencing at least 1 adverse event were reported and analyzed.||Participants Experiencing at least 1 AE|||Number
130429|NCT00547638|Other Pre-specified|Incidence of Skin Blistering at Day 14|The incidence of skin blistering is presented as a tabulation of the presence or absence of skin blistering by treatment group. A formal statistical analysis of the incidence of blistering at Day 14 was performed using the Fisher's Exact Test.|Day 14|Intent to treatment population was analyzed for the incidence of skin blistering at Day 14.||Participants With Blistering at Day 14|||Number
130430|NCT00547638|Other Pre-specified|The Incidence and Extent of Local Acute Inflammatory Reactions Including Edema, Erythema, Pain and Local Temperature at Day 14 and Day 30|Each parameter (edema, erythema, pain and location temperature) is measured on a 4 point scale (0, 1, 2, 3). The individual values are added to generate an overall AIRE Score. AIRE Scores were summarized as good (score=0) versus poor (score>0) by treatment group and compared for differences using the Fisher's Exact Test.|At Day 14 and Day 30|Intent to treat population was analyzed for subjects in each group with Total AIRE Score of 1-12 at Day 14 and Day 30. Analysis is performed on the proportion of subjects in each group with Total AIRE Scores greater than 0 versus those less or equal to 0 at each timepoint.||Participants With AIRE Score >0|||Number
130431|NCT00547638|Other Pre-specified|The Comparison of Test and Control Arms Regarding Incidence of Clinical Infection at Day 14 and Day 30|Incidence of clinical infection (defined by observation of redness, swelling, purulent discharge, pain, increased skin temperature, fever or other systemic signs of injection) collected at the Day 14 and Day 30 visits. A formal statistical analysing using Fisher's Exact Test was performed.|Through Day 30|Intent to treat population was analyzed for the presence of signs of infection at Day 14 and Day 30.||Participants|||Number
131280|NCT00543803|Primary|Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment|The change in alanine aminotransferase (ALT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||IU/L||Inter-Quartile Range|Median
130433|NCT00547638|Primary|The Incidence of Wound Closure Post-treatment, as Defined by Continuous Approximation of Wound Margins From the Time of Wound Closure Until the Day of Evaluation Without Dehiscence or Need for Reclosure.|Data is presented as binomial tables of proportions of successes and failures for each treatment. The 90% two-sided exact confidence intervals (CI) for the differences in the proportions for each study group was calculated. The upper limit of the 90% CI was then taken to represent the upper limit of the one-sided 95% CI. The primary objective of the study was met if the upper limit of the one-sided 95% CI of the difference in proportions (comparator minus treatment) did not exceed 8%.|14 days (±2 days)|Intent to treat population results are presented.With respect to Measure Description it is defined as the number of participants in each group with successful wound-closure (approximation).||Participants|||Number
130434|NCT00550173|Secondary|Probability of OS at 12 Months|OS time is censored at the date of last contact for participants who were still alive or lost to follow-up.|Month 12|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.||percent chance of survival||95% Confidence Interval|Number
130435|NCT00550173|Secondary|Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status|EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated.|Randomization to date of PD or death up to 38 months|A subset of the Q-ITT Population who had EGFR samples; Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy.||participants|||Number
130436|NCT00550173|Secondary|Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)|TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).|Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months|A subset of the Q-ITT Population that included participants with LCSS results; Q-ITT Population: defined as all participants, with nonsquamous histology, who were randomized to therapy.||months||95% Confidence Interval|Median
130437|NCT00550173|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)|DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to disease progression up to 38 months|Q-ITT-TA Population: defined as all participants, with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.||percentage of participants|||Number
130438|NCT00550173|Secondary|Number of Participants With Adverse Events|A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.|Randomization up to 39 months|Safety Population defined as non-squamous participants who received at least 1 dose of study therapy (pemetrexed plus erlotinib or pemetrexed or erlotinib). One participant was assigned to pemetrexed (single therapy) but received erlotinib (single therapy) at first cycle and this lead to the discrepancy of participants for the safety analysis.||participants|||Number
130439|NCT00550173|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death from any cause.|Baseline to date of death from any cause up to 45.5 months|Q-ITT Population: defined as all participants with nonsquamous histology, who were randomized to therapy. Survival time was censored at the date of last contact for participants who were still alive or lost to follow-up, number of participants censored 35 (pemetrexed plus erlotinib), 44 (erlotinib) and 31 (pemetrexed).||months||95% Confidence Interval|Median
130440|NCT00550173|Secondary|Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.|Randomization to measured disease progression up to 38 months|Q-ITT Population - Tumor Analyzable (Q-ITT-TA) Population: defined as all participants with nonsquamous histology, who were randomized to therapy and had measurable or evaluable lesions at baseline.||percentage of participants|||Number
130441|NCT00550173|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.|Randomization to measured PD up to 38 months|Qualified Intent to Treat (Q-ITT) Population defined as all participants with nonsquamous histology, who were randomized to therapy.||months||95% Confidence Interval|Median
130478|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
130442|NCT00550147|Secondary|Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)|The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, & Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child.|See Arm/Group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
130443|NCT00550147|Secondary|Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale|The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24.|See arm/group - repeated measures analysis|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
130444|NCT00550147|Secondary|Modified Overt Aggression Scale (MOAS)|"The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates no aggression and a score of 235 indicates the most severe and frequent aggressive outbursts."|See arm/group - repeated measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
130445|NCT00550147|Secondary|CGI-S: Clinical Global Improvement Scale|"The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates normal, not ill at all and a score of 7 indicates among the most extremely ill patients."|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
130446|NCT00550147|Primary|RAAPP: Rating of Aggression Against People and/or Property Scale|The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior).|See Arm/Group - Repeated Measures|Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF).||units on a scale||Standard Deviation|Mean
130447|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease|Subjects who achieved inactive disease based on DAS 28 CRP (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
130448|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease|Subjects who achieved inactive disease based on the DAS 28 ESR (score <2.6). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
130449|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 CRP Low Disease|Subjects who achieved low disease activity based on the DAS 28 CRP (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
130450|NCT00550043|Secondary|Percentage of Subjects Who Achieved DAS 28 ESR Low Disease|Subjects who achieved low disease activity based on the DAS 28 ESR (score <3.2). Subjects who achieved low disease activity were classified as responders in this analysis.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
130451|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus C-reactive protein (CRP). A higher score indicated more disease activity. The mean change from baseline (which represent decreases in the DAS 28 CRP scores) are shown as positive numbers in these analyses. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
130544|NCT00549393|Other Pre-specified|Bacteremia|per protocol analysis of incidence of bacteremia comparing those in treatment and control groups|duration of ICU stay, median 3 days|Per protocol||events per 1000 at-risk days||95% Confidence Interval|Number
130452|NCT00550043|Secondary|Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score|Calculation of the disease activity score 28 (DAS 28) score was based on the tender joint count, plus swollen joint count, plus PGA, plus Erythrocyte sedimentation rate (ESR). The DAS28-ESR is expressed as units on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6. The mean change from baseline (which represent decreases in the DAS 28 ESR scores) are shown as positive numbers in these analyses.|Baseline, Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Units on a scale||Standard Deviation|Mean
130453|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 70 Improvement|"The ACR 70 is defined as ≥ 70% improvement in tender joint count plus~≥ 70% improvement in swollen joint count plus ≥ 70% improvement in 3 of the following 5 criteria: subject’s assessment of pain, PGA, PHGA, subject’s self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change."|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
130454|NCT00550043|Secondary|The Percentage of Subjects Achieving ACR 50 Improvement|The ACR 50 is defined as ≥ 50% improvement in tender joint count plus ≥ 50% improvement in swollen joint count plus ≥50% improvement in 3 of the following 5 criteria: subject’s assessment of pain, PGA, PHGA, subject’s self-assessed disability HAQ, and ESR or CRP, whichever shows the greatest change.|Day 28|mITT Population: subjects who were enrolled, took at least 1 dose of study drug, and had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects who discontinued before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
130455|NCT00550043|Primary|The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement|The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: subject’s assessment of pain, Subject’s global assessment of disease activity (PGA), Physician’s global assessment of disease activity (PHGA), subject’s self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.|Day 28|modified intent-to-treat (mITT) Population: subjects enrolled, took 1 dose of study drug, had predose and at least 1 post baseline Rheumatoid arthritis (RA) assessments. Subjects discontinuing before the last scheduled efficacy evaluation had data imputed for time points after discontinuation; they had their last observation carried forward (LOCF).||Percentage of participants|||Number
130456|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.|52 weeks (double blind treatment period + open label extension treatment period)|The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received). It included 3 + 3 patients treated during the 1st treatment period only, 26 + 28 patients treated during the 2nd treatment period only and 54 + 55 patients treated during both periods.||participants|||Number
130457|NCT00549939|Secondary|Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes|"When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.~A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism."|12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.||participants|||Number
130458|NCT00549939|Secondary|Relative Change in Detrusor Compliance|Relative change = 100 * (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).||percentage of mL/cmH2O||Standard Error|Least Squares Mean
130459|NCT00549939|Secondary|Detrusor Compliance|"Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure.~It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet)."|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post baseline detrusor compliance values. Patients were included in the treatment group to which they were allocated as per randomization.||mL/cmH20||Standard Deviation|Mean
130460|NCT00549939|Secondary|Relative Change in Detrusor LPP|Relative change = 100 * (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline|12 weeks (double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).||percentage of cmH2O||Standard Error|Least Squares Mean
130461|NCT00549939|Secondary|Absolute Change in Detrusor LPP|Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline|12 weeks ((double blind treatment period)|The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).||cmH2O||Standard Error|Least Squares Mean
130462|NCT00549939|Secondary|Detrusor Leak Point Pressure (LPP)|Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.|baseline and 12 weeks (double blind treatment period)|The analysis was performed on the Intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post-baseline LPP values. Patients were included in the treatment group to which they were allocated as per randomization.||cmH2O||Standard Deviation|Mean
130545|NCT00549393|Secondary|Central Line Associated-bloodstream Infection (CLABSI)|Comparing incidence of central line-associated bloodstream infections between treatment and control groups|participants were followed for the duration of ICU stay, median stay 3 days|||events per 1000 at-risk days||95% Confidence Interval|Number
130463|NCT00549939|Primary|Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O|"Detrusor Leak Point Pressure (LPP) was measured by cystometry.~For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained.~Investigators reading was then consolidated by the review of all cystometry data by 2 external Expert Reviewers, who were blinded for the study treatment.~The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion)."|12 weeks (double blind treatment period)|The Intent-to-treat (ITT) population was used for the analysis. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.||participants|||Number
130464|NCT00549900|Primary|Number of Subjects Reporting Medically Significant Adverse Events|Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month7)|||Subjects|||Number
130465|NCT00549900|Primary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters|"Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells.~Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below."|At Month 0 and Month 7|Analysis was performed on subjects from the Total vaccinated cohort that completed the study.||Subjects|||Number
130466|NCT00549900|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Day 0-29) after any vaccination|||Subjects|||Number
130467|NCT00549900|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Day 0-6) period following each vaccination|||Subjects|||Number
130468|NCT00549900|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Day 0-6) period following each vaccination|||Subjects|||Number
130469|NCT00549900|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)|||Subjects|||Number
130470|NCT00549783|Secondary|Direct Costs for the United Kingdom|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom.|52 Weeks|Intent-to-treat, which consists of all patients in the United Kingdom who were randomized (started study) and received a baseline injection.||British Pound (GBP)||Standard Deviation|Mean
130471|NCT00549783|Secondary|Direct Costs for Sweden|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden.|52 Weeks|Intent-to-treat, which consists of all patients in Sweden who were randomized (started study) and received a baseline injection.||Swedish Krona (SEK)||Standard Deviation|Mean
130472|NCT00549783|Secondary|Direct Costs for Germany|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany.|52 Weeks|Intent-to-treat, which consists of all patients in Germany who were randomized (started study) and received a baseline injection.||Euro (EUR)||Standard Deviation|Mean
130473|NCT00549783|Secondary|Direct Costs for Canada|Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada.|52 Weeks|Intent-to-treat, which consists of all patients in Canada who were randomized (started study) and received a baseline injection.||Canadian dollar (CAD)||Standard Deviation|Mean
130474|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 52|Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Scores on a Scale||Standard Deviation|Mean
130475|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 24|Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Scores on a Scale||Standard Deviation|Mean
130476|NCT00549783|Secondary|Activities of Daily Living Quality of Life (QOL) Score at Week 12|Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.|Baseline, Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Scores on a Scale||Standard Deviation|Mean
130479|NCT00549783|Secondary|Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
130480|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected|Week 52|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
130481|NCT00549783|Secondary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12|Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 12|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
130482|NCT00549783|Primary|Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24|Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale [GAS]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.|Week 24|Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.||Percentage of Patients|||Number
130483|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msSBP|Successful control in msSBP is defined as <140 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
130484|NCT00549770|Secondary|Percentage of Participants Who Achieved Successful Control in msDBP|Successful control in msDBP is defined as msDBP <90 mmHg.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
130485|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
130486|NCT00549770|Secondary|Percentage of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||Percentage of participants|||Number
130487|NCT00549770|Secondary|Change From Baseline in Nighttime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am.|baseline, 8 weeks|Participants from the ABPM subset, who had both baseline nighttime and week 8 nighttime values, were included in the analysis only.||mmHg||Standard Error|Least Squares Mean
130488|NCT00549770|Secondary|Change From Baseline in Daytime maDBP and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.||mmHg||Standard Error|Least Squares Mean
130489|NCT00549770|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8.|baseline, 8 weeks|Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values.||mmHg||Standard Error|Least Squares Mean
130490|NCT00549770|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||mmHg||Standard Error|Least Squares Mean
130491|NCT00549770|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|baseline, week 8|Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period.||mmHg||Standard Error|Least Squares Mean
130492|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like Events or Colorectal Events (Extension Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).||percentage of participants|||Number
130493|NCT00549757|Other Pre-specified|Mean Changes in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Month 3 and Month 6 (Core : Active Treatment Phase)|"The eGFR calculation was based on the Abbreviated Modification of Diet in Renal Disease (MDRD) Study Equation. Using this method, the applicable MDRD formula to calculate eGFR was as follows:~Estimated GFR (mL/min/1.73 m^2) = 175 x (serum creatinine in mg/dL) -1.154 x (Age in years) -0.203 x (0.742 if female) x (1.210 if Black)~Mean changes in eGFR from baseline to month 3 and month 6 were included for analysis. The LS Mean and Standard Error were based on an ANCOVA repeated-measure model with treatment, visit, treatment-by-visit and baseline eGFR as effect terms."|Baseline to Month 3 and Month 6|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. At each visit (baseline, Month 3 and Month 6) , only patients with values at both baseline and post-baseline time point are included.||mL/min/1.73 m^2||Standard Error|Least Squares Mean
130494|NCT00549757|Other Pre-specified|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) to Month 6 and to Last Measurement (Core : Active Treatment Phase)|"Baseline is the geometric mean of last 3 measurements before visit 3, Post-baseline value is the geometric mean of last 3 measurements during each visit.~Change from Baseline = Post - Baseline."|Baseline, Month 6 , last measurement (maximum at 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Last observation carried forward (LOCF) computation technique was used for month 6 data. At each visit, only patients with values at both baseline and this time point are included.||mg/mmol||95% Confidence Interval|Geometric Mean
130495|NCT00549757|Other Pre-specified|Percentage of Participants With Angioedema/Angioedema-like or Colorectal Events (Core : Active Treatment Phase)|AEs of special interest were reported according to a post-marketing commitment to Health Authorities and included angioedema/angioedema-like events and colorectal events/ procedures|Time from randomization to the first event (Maximum 50 months)|Safety Set (SAF) - All patients who received at least one dose of trial medication. Patients were analyzed according to the treatment they received.||percentage of participants|||Number
130496|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130497|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130498|NCT00549757|Primary|Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130499|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|||percentage of participants|||Number
130500|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130501|NCT00549757|Primary|Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130502|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Extension Phase)||From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130503|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Extension Phase)||from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130504|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/EOT.||percentage of participants|||Number
130505|NCT00549757|Primary|Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130506|NCT00549757|Primary|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130507|NCT00549757|Primary|Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase)|To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130508|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).||percentage of participants|||Number
130509|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Extension Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)"|From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Extension-phase Analysis Set (EAS) – All patients who had at least one scheduled or unscheduled visit or who died post cut-off date 20-Dec-2011/end of treatment (EOT).||percentage of participants|||Number
130510|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Renal Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary renal composite endpoint:~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory.The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130511|NCT00549757|Secondary|Percentage of Participants With Occurrence of Secondary Cardiovascular Composite Endpoint (Core: Active Treatment Phase)|"Occurrence was defined as the first event of the following secondary cardiovascular composite endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)"|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130512|NCT00549757|Primary|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase)|ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130513|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130514|NCT00549757|Primary|Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130515|NCT00549757|Primary|Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase)|Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.|Time from randomization to the first event (Maximum 50 Months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130516|NCT00549757|Primary|Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase)||Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130517|NCT00549757|Primary|Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase)|"Occurrence was defined as the first event of the following composite primary endpoint:~Cardiovascular (CV) death~Resuscitated sudden death~Non-fatal myocardial infarction (MI)~Non-fatal stroke~Unplanned hospitalization for heart failure (HF)~Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.~Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL."|Time from randomization to the first event (Maximum 50 months)|Full Analysis Set (FAS) - All patients randomized except mis-randomized patients who did not receive study drug. Mis-randomized patients were defined as not qualified for randomization and were inadvertently randomized into the study.||percentage of participants|||Number
130518|NCT00549718|Primary|Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.||scores on a scale||95% Confidence Interval|Least Squares Mean
130519|NCT00549718|Secondary|CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 (‘normal’, not ill) to 7 (extremely ill).|6 weeks|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population.All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement,were in the efficacy analysis in the treatment group to which they were randomized.||scores on a scale||95% Confidence Interval|Least Squares Mean
130520|NCT00549640|Secondary|The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.|The average composite nicotine withdrawal score (using Minnesota Nicotine Withdrawal Scale) change from baseline for the first 14 days following target quit date. Scale scores range from 0 (none) to 4 (severe).|baseline and 14 days|Analysis was restricted to subjects who had diary information available for the first 14 days following target quit date||units on a scale||Standard Deviation|Mean
130521|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of study (week 24) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|6 months|Intention to treat (ITT). subject who discontinued study participation were counted as using tobacco.||participants|||Number
130522|NCT00549640|Primary|Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.|Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)|8 weeks|Intention to Treat. subjects with missing information were assumed to be using tobacco.||participants|||Number
130523|NCT00549601|Secondary|Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3|The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline to Month 1 and Month 3|The Safety population was made up of all the randomized patients who had taken at least one dose of the study medication.||Units on a scale||Standard Deviation|Mean
130524|NCT00549601|Secondary|Overall Patient Satisfaction With Treatment|Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 “Very good” - 5 “Very poor”) at the end of the study (Month 3). A higher score indicates less satisfaction.|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Participants|||Number
130525|NCT00549601|Secondary|Overall Caregiver Satisfaction With Treatment|Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 “Very good” – 5 “Very poor”) at the end of the study (Month 3). A higher score indicates less satisfaction.|At end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Participants|||Number
130526|NCT00549601|Secondary|Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study.|Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken.|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Percentage of participants|||Number
130527|NCT00549601|Secondary|Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only)|Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Percentage of participants|||Number
131281|NCT00543764|Primary|Operative Time|Length of Time in surgery|3 years|||hours||95% Confidence Interval|Mean
130528|NCT00549601|Primary|Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study|Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT).|Baseline to end of study (Month 3)|The Safety population included all randomized patients who received at least one dose of the study medication.||Percentage of participants|||Number
130529|NCT00549549|Secondary|Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events|The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.|Baseline to Day 14/Early Termination|ITT||Participants|||Number
130530|NCT00549549|Secondary|Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events|The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)|Baseline to Day 14/Early Termination|ITT||Participants|||Number
130531|NCT00549549|Secondary|Participants Global Evaluation of Study Medication Score|"The participant rated the study medication that they received during the study by completing the following question:~How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor"|Day 9|ITT||Scores on a scale||Standard Deviation|Mean
130532|NCT00549549|Secondary|Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy|Withdrawal due to lack of efficacy was assessed from Days 1 to 8|Day 1 to Day 8|ITT||Participants|||Number
130533|NCT00549549|Secondary|Percentage Change From Baseline in the Patient’s Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13|The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.|Baseline to Day 13|ITT, LOCF||Percentage change||Standard Deviation|Mean
130534|NCT00549549|Secondary|Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline|The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline|ITT, LOCF||Units on a scale||Standard Deviation|Mean
130535|NCT00549549|Secondary|Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient’s Assessment of Pain Intensity|The Patient’s assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2|ITT and LOCF||Participants|||Number
130536|NCT00549549|Secondary|Change From Baseline in Time Weighted Average of Patient’s Assessment of Pain Intensity Over 8, 12, and 24 Hours|Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity|Baseline, 8, 12, and 24 hours post first dose|ITT and LOCF||Scores on a scale||Standard Deviation|Mean
130537|NCT00549549|Secondary|Change From Baseline in Patient’s Assessment of Pain Intensity on Day 1|The patient’s assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).|Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
130538|NCT00549549|Secondary|Change From Baseline in Patient’s Assessment of Pain Intensity|The Patient’s assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).|Baseline, Day 2 to Day 13|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
130539|NCT00549549|Secondary|Number of Participants With Warmth Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14|Warmth was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Participants|||Number
130540|NCT00549549|Secondary|Number of Participants With Redness Present According to Physician’s Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination|Redness was assessed by the physician as present or absent.|Baseline, Day 5, Day 9 and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Participants|||Number
130541|NCT00549549|Secondary|Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling|Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)|Baseline, Days 5, 9 and 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
130542|NCT00549549|Secondary|Change From Baseline in Physician’s Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness|Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).|Baseline, Day 5, Day 9, and Day 14/Early Termination|Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF||Scores on a scale||Standard Deviation|Mean
130543|NCT00549549|Primary|Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity|The Patient’s Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).|Baseline and Day 2|Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)||Scores on a scale||Standard Deviation|Mean
130547|NCT00549328|Secondary|Characterization of Participant Populations by Identification of Intra-tumoral Biomarkers|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
130548|NCT00549328|Secondary|Levels of Circulating Biomarkers in Plasma|Biomarkers are proteins that respond in a unique way to treatment with the study drug; however, levels of proteins were not collected for this measurement. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
130549|NCT00549328|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
130550|NCT00549328|Secondary|Progression-Free Survival|Progression-free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause, whichever occurs first. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
130551|NCT00549328|Secondary|Number of Participants Who Had a Complete or Partial Response, or Stable Disease|Disease control was measured. Stable disease (SD) is defined as neither partial response (at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks) nor progressive disease (PD; a 20% increase in the sum of the longest diameters of target lesions, taken as a reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population|||||
130552|NCT00549328|Primary|Percentage of Participants Who Achieved Either a Confirmed Complete Response or Partial Response Per RECIST Criteria|The best overall response using Response Evaluation Criteria In Solid Tumors (RESIST) was measured. Complete response is defined as the disappearance of all known lesion(s), confirmed at 4 weeks, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions taken as a reference to baseline sum of the longest diameters, confirmed at 4 weeks. No formal efficacy analyses were performed due to early termination of the study.|Baseline through End of Study (up to 2 years)|All Treated Population: all participants who met inclusion criteria and willingly consented to participate in the study|||||
130553|NCT00549302|Secondary|Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52|World Health Organization Functional Classification Assessment (WHO FC) is a method of classifying disease severity in PAH. The classes are: Class I: pulmonary hypertension (PH) but without resulting limitation of physical activity, Class II: PH resulting in slight limitation of physical activity, Class III: PH resulting in marked limitation of physical activity, Class IV: PH with inability to carry out any physical activity without symptoms. Deterioration of WHO FC is defined as moving to a higher WHO FC within one visit. Results are presented as Kaplan-Meier estimates (% probability) of remaining free from WHO FC deterioration after a given time.|Baseline and Weeks 16, 28, 40 and 52|Safety Population: all randomized participants who received at least 1 dose of study drug.||probability (%) no PAH deterioration||95% Confidence Interval|Number
130554|NCT00549302|Secondary|Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52|Borg dyspnea score is a participant rated measure of their greatest degree of shortness of breath during exertion (6-minute walk test). Score ranged from 0 (nothing at all) to 10 (very, very severe [maximal]).|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed the Borg Dyspnea Assessment; LOCF||units on a scale||Standard Deviation|Mean
130555|NCT00549302|Secondary|6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52|6MWD measured the distance a participant was able to walk unassisted in 6 minutes.|Baseline and Weeks 16, 28, 40 and 52|All randomized participants who received at least 1 dose of study drug and who completed 6MWD test; Last Observation Carried Forward (LOCF)||meters (m)||Standard Deviation|Mean
130556|NCT00549302|Primary|Number of Participants With Adverse Events (AEs)|A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.|Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)|Safety Population: all randomized participants who received at least 1 dose of study drug.||participants|||Number
130557|NCT00547534|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.|Two years|||Lymphoma Subjects|||Number
130558|NCT00547534|Secondary|Toxicity of Drug Combination in the Subjects||Two years|||Lymphoma Subjects|||Number
130559|NCT00547534|Primary|Number of Participants With Progression Free Survival at 2 Years|To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.|Two years|Analysis was per protocol.||Participants|||Number
130560|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the LTE Period: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC) - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE period, were evaluated. n=number of participants evaluated.||participants|||Number
130568|NCT00547521|Secondary|Number of Participants With Negative Status for RF up to 7 Days After Last Dose of Abatacept in the LTE Period - All Treated Participants in LTE Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result).|Continuously from start of LTE period up to 7 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE and who had an RF test result up to 7 days post the last dose of abatacept in the LTE study, were evaluated.||participants|||Number
130561|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Electrolytes, Glucose, Protein, and Metabolite) During the LTE Period - All Treated Participants in LTE Study|Sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or <LLN); glucose (serum): <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx).|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE study, were summarized. n=number of participants evaluated.||participants|||Number
130562|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry (Liver and Kidney Function) During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT), Blood Urea Nitrogen (BUN) and Creatinine MA criteria: ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx; creatinine: >1.5 * pre-Rx.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and with specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.||participants|||Number
130563|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the LTE Period - All Treated Participants in LTE Study|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had specified laboratory values up to 56 days post the last dose of abatacept in the LTE Study, were evaluated. n=number of participants evaluated.||participants|||Number
130564|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the LTE Study - All Treated Participants in LTE Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE Study, were evaluated.||participants|||Number
130565|NCT00547521|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs), or Discontinued Due to AEs and/or SAEs During the LTE Period - All Treated Participants in LTE Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs/SAEs are those events with a relationship to the study therapy of certain; probable; possible; or missing.|Continuously from start of LTE Study up to 56 days post the last dose|Participants who received at least 1 dose of abatacept in the LTE Study and who had events up to 56 days post the last dose of abatacept in the LTE period, were evaluated. Includes all deaths reported during the LTE including those that occurred greater than 56 days after the last dose.||participants|||Number
130566|NCT00547521|Secondary|Number of Participants in DAS 28-CRP Remission and Low Disease Activity (LDA) in the LTE Study - Abatacept Monotherapy Subgroup|Remission was defined as DAS 28-CRP < 2.6 and LDA was defined as DAS 28-CRP <= 3.2. End of ST Study was Day 113. Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.|Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies, and who had values at Day 113 and Day 1345, were evaluated.||participants|||Number
130567|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score and Physical Function (HAQ-DI) Score in the LTE Study - Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup consisted of participants who received SC abatacept and did not receive MTX in the ST and LTE Studies. DAS28-CRP: continuous variable which is a composite of 4 variables:number of tender joints out of 28, number of swollen joints out of 28, C-reactive protein (CRP) in mg/L and self assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. HAQ-DI includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score sums worst scores in each domain and divides by the number of domains answered. Baseline was Day 1 of Short Term Study. Day 113 was the last day of the Short Term Study.|Baseline, Day 113, Day 1345|Participants who received abatacept monotherapy (at least 1 dose of abatacept and no MTX) in the ST and LTE Studies and who had values at Baseline, Day 113, and Day 1345, were evaluated.||units on a scale||Standard Error|Mean
130569|NCT00547521|Secondary|Number of Participants With HAQ Responses in the LTE Study - All Treated Participants in the LTE STudy|HAQ response was defined as an improvement of at least 0.3 units from baseline in the HAQ Disability Index (HAQ DI). Baseline was Day 1 of the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.||participants|||Number
130570|NCT00547521|Secondary|Change From Baseline in HAQ-DI in the LTE Study - All Treated Participants in LTE Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered. Baseline was Day 1 in the ST Study and Day 113 was the last day of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Baseline, Day 113 and Day 1345, were evaluated.||units on a scale||95% Confidence Interval|Mean
130571|NCT00547521|Secondary|Number of Participants in DAS28-CRP Remission and Number of Participants With Low Disease Activity (LDA) in the LTE Study - All Treated Participants in the LTE|DAS28-CRP remission was defined as DAS28-CRP less than 2.6 and LDA was defined as DAS28-CRP less than, equal to 3.2. End of ST Study was Day 113.|Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE study and who had values at Day 113 and Day 1345, were evaluated.||participants|||Number
130572|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement From Baseline in the LTE Study - All Treated Participants in LTE Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline. Baseline was Day 1 of the ST Study. Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at Baseline, Day 113 and Day 1345, were evaluated.||participants|||Number
130573|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score in the LTE Study - All Treated Participants in LTE Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joints out of 28, the number of swollen joints out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96. Baseline was Day 1 of the ST Study; Day 113 was the end of the ST Study.|Baseline, Day 113, Day 1345|Participants who received at least 1 dose of abatacept in the LTE Study and who had DAS28-CRP values at Baseline, Day 113 and Day 1345, were evaluated.||Units on a scale||95% Confidence Interval|Mean
130574|NCT00547521|Secondary|Number of Participants With Abatacept Induced Antibody Responses Over Time During the LTE Study (ECL Method) - All Treated Participants in LTE Study|The Meso-Scale Discovery (MSD) electrochemiluminescence (ECL) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10. Antibody responses included CTLA4 and possibly immune globulin (IG), IG and/or junction region.|Days 197, 281, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541, 1625, 1709, 1821, 1989, days post dose: 28, 56, 85, 168|Participants who received at least 1 dose of abatacept in the LTE Study and who had values at each specified timepoint, were evaluated.||participants|||Number
130575|NCT00547521|Secondary|Minimum Plasma Concentration (Cmin) at Each Visit During the 4 Month Treatment Period of the ST Study|Cmin serum abatacept concentration was obtained directly from the concentration-time data.|Days 1, 15, 29, 43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period. n=those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||microgram/mL||Full Range|Geometric Mean
130576|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Vital Signs During the ST Study|Vital signs measurements (including seated blood pressure, heart rate and temperature) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs/physical examination were clinically meaningful.|At screening and on days 1,15,29,43, 57, 85 and 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
130577|NCT00547521|Secondary|Number of Participants With Anti-double Stranded DNA (dsDNA) Category at Day 113 of the ST Study|Anti-dsDNA antibody status was categorized as negative or positive based upon assay-specific numeric cut-off values.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
130578|NCT00547521|Secondary|Number of Participants With Anti-nuclear Antibody (ANA) Category at Day 113 of the ST Study|ANA status was categorized as negative or positive corresponding to the following dilutions: less than 1:160 and greater than equal to 1:160.|Day 113.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
130579|NCT00547521|Secondary|Number of Participants With MAs in Urinalysis During the ST Study: Protein, Glucose, Blood, Leukocyte Esterase, Red Blood Cells (RBC) and White Blood Cells (WBC)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis: protein, glucose, blood, leukocyte esterase, RBC, WBC: >= 2+ (or, if value >= 4, or if pre-Rx value = 0 or 0.5, then >= 2x or if pre-Rx value =1, then >= 3, or if pre-Rx = 2 or 3, then >= 4).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.||participants|||Number
130580|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Glucose (Fasting Serum), Albumin, Glucose (Serum), Phosphorous (Inorganic) and Uric Acid|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. Glucose (fasting serum): <0.8 * LLN or >1.5 ULN (if pre-Rx <LLN, then <2.0 * pre-Rx or >ULN; albumin: <0.9 * LLN (if pre-Rx < LLN, then <0.75 * pre-Rx); uric acid: >1.5 * ULN (if pre-Rx > ULN, then >2.0 * pre-Rx); phosphorous (inorganic):<0.75 * LLN or >1.25 * ULN (if pre-Rx < ULN, then <0.67 * pre-Rx or < ULN. If pre-Rx > ULN, then >1.33 * re-Rx or < LLN); glucose (serum): <65 mg/dL or >220 mg/dL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, n= number of participants evaluated for this measure.||participants|||Number
130581|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Creatinine, Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total) and Protein (Total)|MAs= laboratory measurements marked as abnormal: creatinine: >1.5 * pre-Rx; sodium (serum):<0.95 * LLN or >1.05 * ULN (if pre-Rx < LLN, then <0.95 * pre-Rx or >1.05 * ULN. If pre-Rx > ULN, then >0.95 * pre-Rx or < ULN); potassium (serum):<0.9 * LLN or >1.1 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN; chloride (serum),protein (total):<0.9 * LLN or >1.1 8 ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >1.1 * pre-Rx or < LLN); calcium (total): <0.8 * LLN or >1.2 * ULN (if pre-Rx < LLN, then <0.9 * pre-Rx or > ULN. If pre-Rx > ULN, then >0.75 * pre-Rx or < ULN).|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
130582|NCT00547521|Secondary|Number of Participants With MAs in Serum Chemistry During the ST Study: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin (Total), G-Glutamyl Transferase (G-GT) and Blood Urea Nitrogen (BUN)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP: >2.0 * ULN (if pre-Rx > ULN, then >3 * pre-Rx); AST, ALT: > 3 * ULN (if pre-Rx > ULN, then > 4 * pre-Rx); bilirubin (total): >2 * ULN, or if pre Rx > ULN then >4 * Pre Rx; BUN : >2 * pre Rx; GGT : >2 * ULN, or if pre Rx > ULN then >3 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
130583|NCT00547521|Secondary|Number of Participants With MAs in Hematology During the ST Study: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Neutrophils + bands (absolute): <1.00 * 10^3cells/microlitre (uL); lymphocytes (absolute): <0.75 * 10^3 cells/uL or >7.50 * 10^3 cells/uL; monocytes (absolute): >2.00 * 10^3 cells/uL; basophils (absolute): >0.40 * 10^3 cells/uL; eosinophils (absolute): >0.75 * 10^3 cells/uL.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept)in the ST period.||participants|||Number
130584|NCT00547521|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology During the ST Study: Hemoglobin, Hematocrit, Platelet Count, Erythrocytes and Leukocytes|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre Rx); hematocrit: <0.75 * pre-Rx value; platelet count: <0.67 * (LLN -lower limit of normal) (or, if pre-Rx value <LLN, then <0.5 * pre-Rx value and <100,000/mm^3); leukocytes: <0.75 * LLN or >1.25 * ULN (or, if pre-Rx value <LLN, then <0.8 * pre-Rx or >(ULN -upper limit of normal) ; erythrocytes: <0.75 * pre Rx.|Continuously from start of ST period up to 56 days post the last dose in the short-term period or start of the long-term period, whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period.||participants|||Number
130585|NCT00547521|Secondary|Number of Participants With AEs of Special Interest During the ST Study|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of particular importance were associated with the use of immunomodulatory agents: infections, autoimmune disorders, malignancies, and injection reaction AEs (systemic AEs occurring within 24 hours of SC injection and local injection site reactions) were recorded.|Continuously through ST period (up to Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.||participants|||Number
130586|NCT00547521|Secondary|Number of Participants Who Experienced Drug-related SAEs and Drug-related AEs During the ST Study|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.||participants|||Number
130616|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.|Week 96|Safety Population||participants|||Number
130587|NCT00547521|Secondary|Number of Participants Who Died, Experienced SAEs, Experienced AEs or Who Discontinued Due to AEs During the ST Study|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs or SAEs were recorded.|Continuously through ST period (upto Day 113). Includes the data from start of study drug therapy up to 56 days after the last dose (Day 113) or start of the long-term period whichever occurred first.|All treated participants analysis population included all participants who received at least 1 dose of study medication (abatacept) in the ST period, were included in the safety analyses.||participants|||Number
130588|NCT00547521|Secondary|Cross Tabulations of Number of Participants With Positive and Negative Status for RF at Day 113 With Baseline, in the ST Study|RF is an autoantibody that is usually present in the serum of people with rheumatoid arthritis. The cut-point value for seroconversion was 15 IU/mL (>= 15 IU/mL resulted in a positive result). Cross-tabulation of frequency of seroconversion of RF at Day 113 with baseline, in the ST period, was provided.|Baseline and Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period.||participants|||Number
130589|NCT00547521|Secondary|Change From Baseline in All HAQ-DI Components at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period. n is the number of participants with baseline and post-baseline values.||Units on a scale||95% Confidence Interval|Mean
130590|NCT00547521|Secondary|Change From Baseline in Physical Functioning (HAQ-DI) at End of the 4-month Treatment Period (Day 113) of the ST Study|HAQ-DI takes into account participant’s use of aids or devices or assistance in scoring algorithm for a disability category. The questionnaire includes 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 = unable to do. Higher scores indicate greater dysfunction. The score is calculated by summing worst scores in each domain and dividing by the number of domains answered.|Baseline and Month 4 (Day 113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.||Units on a scale||95% Confidence Interval|Mean
130591|NCT00547521|Secondary|Number of Participants With Clinically Meaningful Improvement at End of 4-month (Day 113) of the ST Study|A clinically meaningful improvement is defined as a greater than or equal to 1.2 reduction in DAS28-CRP score from baseline.|Day 113.|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.||participants|||Number
130592|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum . It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL(MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Baseline and day 15, 29, 43, 57, 85 and 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.|||||
130593|NCT00547521|Primary|Cross Tabulations of the Number of Participants With Positive and Negative Immunogenicity Status at Baseline and Each Visit During the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Baseline and on day 15, 29, 43, 57, 85 and 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.The overall percentage of subjects who had at least one positive sample was very low, therefore this analysis was not necessary.|||||
130594|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for MSD Results)|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than the ELISA method. For anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive IMG samples on Day 113, therefore this analysis was not necessary.|||||
130617|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 48|Safety Population||participants|||Number
130595|NCT00547521|Primary|Immunogenicity in MTX Naive and MTX-previous Users in Cohort 1 at Day 113 of the ST Study (for ELISA Results)|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. There were no positive Immunoglobulin G (IMG) samples on Day 113, therefore this analysis was not necessary.|||||
130596|NCT00547521|Primary|Number of Participants With Positive Anti-abatacept Responses to Abatacept (Meso-Scale Discovery [MSD] Electrochemiluminescence [ECL] Assay Method) Over Time During the ST Study|The ECL (MSD) assay method is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. It is more sensitive and has a higher drug tolerance than ELISA method. For the anti-abatacept antibody ECL (MSD) assay, a sample was considered seropositive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept, or abatacept and CTLA4-T. Those responses that were not positive in the initial screen or were not confirmed to be positive based on immunodepletion were reported as seronegative and were assigned a value of < 10.|Day 15, 29, 43, 57, 85,113 and 28, 56 and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n=number of participants who were evaluated for this measure at each timepoint, for each group respectively.||participants|||Number
130597|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (ELISA Method) Over Time During the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 15, 29, 43, 57, 85,113 and 28, 56, and 85 days post last dose.|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses. n = those participants who were evaluated for this measure at each timepoint, for each group respectively.||participants|||Number
130598|NCT00547521|Secondary|Change From Baseline in DAS28-CRP Score at End of 4-month (Day 113) of the ST Study|DAS28-CRP is a continuous variable which is a composite of 4 variables: the number of tender joint out of 28, the number of swollen joint out of 28, C-reactive protein (CRP) in milligrams/Liter (mg/L) and subject assessment of disease activity measure on a VAS of 100mm. DAS 28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * VAS + 0.96.|Baseline and Month 4 (Day113).|All treated participants included those participants who received at least 1 dose of the study medication (abatacept) in the ST period with baseline and post-baseline values.||Units on a scale||95% Confidence Interval|Mean
130599|NCT00547521|Primary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses (Enzyme-linked Immunosorbent Assay [ELISA] Method) at Day 113 of the ST Study|ELISA is a validated, sensitive assay technique used to analyze presence of abatacept-specific antibodies in serum. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 25.|Day 113|Treated participants in the ST period who were evaluable for anti-abatacept or anti-CTLA4-T responses.||participants|||Number
130600|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||ug/L||95% Confidence Interval|Geometric Mean
130601|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||ug/L||95% Confidence Interval|Geometric Mean
130602|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96|Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||nanograms per Liter (ng/L)||95% Confidence Interval|Geometric Mean
130603|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96|P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.|Baseline, Week 96|Safety Biomarker Population. Some participants had withdrawn by Week 96.||micrograms per Liter (ug/L)||95% Confidence Interval|Geometric Mean
130604|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
130855|NCT00546754|Primary|Change in Diastolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
130605|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
130606|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).|Baseline, Week 96|Safety Population. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
130607|NCT00549198|Other Pre-specified|Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96|Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).|Baseline, Week 96|Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.||ratio||95% Confidence Interval|Geometric Mean
130608|NCT00549198|Secondary|"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"|Participants were asked at each visit whether or not they utilized unplanned healthcare resources.|Baseline to Week 96|ITT-E Population. The number of participants analyzed differed by visit because some had withdrawn during the study and some did not have an assessment performed.||participants|||Number
130609|NCT00549198|Secondary|Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96|Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24.|Week 96|On-Treatment Resistance: all participants who fulfilled the definition of protocol-defined virological failure (VF) who had paired baseline and VF genotypic data for analysis. One ABC/3TC participant took prohibited medication that potentially lowered efavirenz levels just prior to VF, allowing for the emergence of unexpected NRTI resistance.||participants|||Number
130610|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||cells/mm^3||Inter-Quartile Range|Median
130611|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||cells/mm^3||Inter-Quartile Range|Median
130612|NCT00549198|Secondary|Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24|CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.||cells/millimeters cubed (mm^3)||Inter-Quartile Range|Median
130613|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 96|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.||participants|||Number
130614|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 48|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.||participants|||Number
130615|NCT00549198|Secondary|Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24|HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.|Week 24|ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.||participants|||Number
130632|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 48|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
130618|NCT00549198|Secondary|Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.|Week 24|Safety Population||participants|||Number
130619|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high.|Baseline, Week 96|Safety Population||participants|||Number
130620|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 48|Safety Population||participants|||Number
130621|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.|Baseline, Week 24|Safety Population||participants|||Number
130622|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 96|Safety Population||participants|||Number
130623|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 48|Safety Population||participants|||Number
130624|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.|Baseline, Week 24|Safety Population||participants|||Number
130625|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 96|Safety Population||participants|||Number
130626|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 48|Safety Population||participants|||Number
130627|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.|Baseline, Week 24|Safety Population||participants|||Number
130628|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 96|Safety Population||participants|||Number
130629|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 48|Safety Population||participants|||Number
130630|NCT00549198|Secondary|Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24|Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.|Baseline, Week 24|Safety Population||participants|||Number
130631|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 96|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
130678|NCT00548808|Secondary|Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.||Units of insulin per day (U/day)||Standard Deviation|Mean
130633|NCT00549198|Secondary|Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24|An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.|Baseline to Week 24|Safety Population: all randomized participants who received at least one dose of study medication||participants|||Number
130634|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||participants|||Number
130635|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||participants|||Number
130636|NCT00549198|Secondary|Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24|"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD."|Week 24|ITT-E Population. Some participants had withdrawn by Week 24.||participants|||Number
130637|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.||participants|||Number
130638|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.||participants|||Number
130639|NCT00549198|Secondary|Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24|BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.||participants|||Number
130640|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population||percent change||Standard Error|Mean
130641|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 96|ITT-E Population||percent change||Standard Error|Mean
130642|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population||percent change||Standard Error|Mean
130643|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 48|ITT-E Population||percent change||Standard Error|Mean
130644|NCT00549198|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population||percent change||Standard Error|Mean
130645|NCT00549198|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24|BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.|Baseline, Week 24|ITT-E Population||percent change||Standard Error|Mean
130646|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||participants|||Number
130730|NCT00548262|Secondary|Change From Baseline in Vital Signs: Weight|Weight measured as kilograms (kg).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with evaluable data.||kg||Full Range|Median
130647|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||participants|||Number
130648|NCT00549198|Secondary|Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24|Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.|Baseline, Week 24|ITT-E Population. Some participants had withdrawn by Week 24.||participants|||Number
130649|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 96|ITT-E Population. Some participants had withdrawn by Week 96.||participants|||Number
130650|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 48|ITT-E Population. Some participants had withdrawn by Week 48.||participants|||Number
130651|NCT00549198|Secondary|Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24|mL, milliliter; min, minute; m^2, meters squared|Baseline, Week 24|ITT-E Population. Some participants had withdrawn from the study by Week 24.||participants|||Number
130652|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 96|ITT-E Population||mL/min||Standard Error|Mean
130653|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.|Baseline, Week 48|ITT-E Population||mL/min||Standard Error|Mean
130654|NCT00549198|Secondary|Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.|Baseline, Week 24|ITT-E Population||mL/min||Standard Error|Mean
130655|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96|Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine.|Baseline, Week 96|ITT-E Population||mL/min/1.73m^2||Standard Error|Mean
130656|NCT00549198|Secondary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24|Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine.|Baseline, Week 24|ITT-E Population||mL/min/1.73m^2||Standard Error|Mean
130657|NCT00549198|Primary|Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48|Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index.|Baseline, Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
130658|NCT00549172|Secondary|Pain at Rest (VAS)|Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year|||units on a scale||95% Confidence Interval|Mean
130659|NCT00549172|Secondary|15-D (General Quality of Life -Assessment Tool)|The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).|One year|||units on a scale||95% Confidence Interval|Mean
130731|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Heart Rate|Supine heart rate measured as beats per minute (bpm).|Baseline to Week 2 Follow-up|Safety analysis population||bpm||Full Range|Median
130732|NCT00548262|Secondary|Change From Baseline in Vital Signs: Supine Blood Pressure|Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).|Baseline to Week 2 Follow-up|Safety analysis population||mmHg||Full Range|Median
130660|NCT00549172|Primary|WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)|The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.|One year|||units on a scale||95% Confidence Interval|Mean
130661|NCT00549172|Primary|Pain After Exercise (VAS)|Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.|One year|||units on a scale||95% Confidence Interval|Mean
130662|NCT00549172|Primary|The Lysholm Knee Score|The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.|One year|||units on a scale||95% Confidence Interval|Mean
130663|NCT00549055|Secondary|Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments|Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).|Months 3, 6, 9 and 12|FAS||Participants|||Number
130664|NCT00549055|Secondary|Frequency of Macugen Administration|Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant – 1)/ duration of treatment.|Baseline up to 28.4 months|FAS||Weeks per injection||Standard Deviation|Mean
130665|NCT00549055|Secondary|Duration of Treatment|Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).|Baseline up to 28.4 months|FAS||Months||Standard Deviation|Mean
130666|NCT00549055|Secondary|Number of Participants With Change in VA: Worsening|Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.||Participants|||Number
130667|NCT00549055|Secondary|Number of Participants With Change in VA: Stabilization|Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.||Participants|||Number
130668|NCT00549055|Secondary|Number of Participants With Change in VA: Improvement|Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.|Months 3, 6, 9 and 12|FAS; n= number of participants with analyzable data.||Participants|||Number
130669|NCT00549055|Primary|Change From Baseline to Final Visit in Visual Acuity (VA) Score|Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.|Baseline, Month 24 or Early Termination|The Full Analysis Set (FAS) was derived from the set of all enrolled participants who were administered at least 1 injection of the study medication and had at least 1 post Baseline efficacy measurement. Participants analyzed refers to number of participants with analyzable data.||Scores on scale||Standard Deviation|Mean
130670|NCT00548886|Secondary|Determine Interobserver Variability When Measuring QT Intervals|Two pediatric electrophysiologists were given photocopies of rhythm strips obtained from the electrocardiograms and the electrophysiologists will then take four separate measurements of the QT interval from each rhythm strip. Interobserver variability was measured between the two electrophysiologists and their measurements on the same rhythm strip. False positive results will be based on measurement error.|During enrollment period||||||
130671|NCT00548886|Primary|Percentage of Subjects With a Positive Result in Absolute QT Interval|QT interval refers to the time interval on the standard electrocardiogram from the beginning of the QRS complex to the end of the T wave. Each participant had four QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint for an absolute QT interval. Lengthening of the absolute QT interval greater than 30 milliseconds on low dose epinephrine infusion would be considered a positive result.|35 minutes|Data not analyzed due to study termination|||||
130672|NCT00548860|Primary|Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.|Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).|From Day 0 through 30 days after the last dose of study drug.|||participants|||Number
130673|NCT00548847|Secondary|Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells)||6 months after cytokine treatment|||participants|||Number
130674|NCT00548847|Primary|Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months|Efficacy is defined as progression-free survival of > 33% at 3 months. This is based on our retrospective data on 10% 3 month survival for relapsed patients. Progression is defined an an increase in blasts in blood or marrow by 50% compared to baseline with at least 20% of all cells being blasts at the time of assessment.|3 months after cytokine treatment|||percentage of progression-free patients|||Number
130675|NCT00548808|Secondary|Safety: Number of Participants With Serious and Non-Serious Adverse Events|Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.|baseline through 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug.||participants|||Number
130676|NCT00548808|Secondary|Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles||baseline, 48 weeks|Full Analysis Set: all randomized participants who received at least one dose of study drug and had baseline and endpoint values.||millimoles/Liter (mmol/L)||Standard Error|Least Squares Mean
130677|NCT00548808|Secondary|Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks||16 weeks, 32 weeks, 48 weeks|Full Analysis Set: all randomized patients who received at least one dose of study drug.||Units of insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
130679|NCT00548808|Secondary|Change From Baseline in Postprandial Blood Glucose Over Time|The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.|Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.||millimoles per liter||Standard Error|Least Squares Mean
130680|NCT00548808|Secondary|7-point Self-monitored Blood Glucose Profiles||Baseline, 16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.||millimoles per liter (mmol/L)||Standard Deviation|Mean
130681|NCT00548808|Secondary|Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time||16 weeks, 32 weeks, 48 weeks|Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.||percentage of participants|||Number
130682|NCT00548808|Secondary|Change in Hemoglobin A1c (HbA1c) Over Time||Baseline, 16 Weeks, 32 Weeks, 48 Weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study.||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
130683|NCT00548808|Primary|Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 48 weeks|Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study. Last observation carried forward.||percent (%) glycated hemoglobin||Standard Error|Least Squares Mean
130684|NCT00548717|Secondary|Overall Survival||1 year|||percentage of participants|||Number
130685|NCT00548717|Secondary|Incidence of Chronic GVHD|"Chronic GVHD will be graded according to the modified Seattle criteria. Chronic GVHD divided into limited and extensive and evaluated across the following systems: skin, cutaneous structures, liver, mouth, eyes, esophagus, intestines, lung, musculoskeletal, serous, nervous, urologic, vagina, hematopoietic, and immune.~Localized skin involvement with or without hepatic dysfunction is classified as limited disease.~Generalized skin involvement or limited disease plus eye involvement, oral involvement, hepatic dysfunction with abnormal liver histology, or involvement of any other target organ was classified as extensive disease.~Lee SJ, Vogelsang G, Flowers ME. Chronic graft‐versus‐host disease. Biol Blood Marrow Transplant.~2003;9:215‐33."|1 year|||percentage of participants|||Number
130686|NCT00548717|Secondary|Incidence of 100 Day Mortality||100 days|||percentage of participants|||Number
130687|NCT00548717|Secondary|To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence|This outcome measure was presented as a comparison between incidence of Grade 0-I aGVHD and Grade II-IV aGVHD across 5 time points (Weeks 1,2,3,8, and 12).|1 year|In the Siro/MMF group, the overall number of participants analyzed was 13, however, the number of participants with the MMF level data available varies at each time point. For the Siro/MMF/Bort group, no data were analyzed due to no data available for this Outcome Measure.||ng/mL||Standard Deviation|Mean
130688|NCT00548717|Secondary|The Rate of Renal Insufficiency|"Renal function will be measured weekly after transplant for 4 weeks, at 8 weeks and then at 3 month intervals from transplantation. Sentinel renal events such as the occurrence of thrombotic microangiopathy will be noted.~The rationale for the substitution of mycophenolate mofetil for tacrolimus is to continue to prevent acute GVHD, but minimize renal toxicity after transplantation. We will thus monitor renal toxicity closely in this study. In our previous experience, the rate of grade III‐V renal toxicity by day 100 after transplantation was about 10%. Here, grade III is defined as a creatinine level between 3.1 to 6 times the normal level, grade IV is defined as a creatinine level 6 times or more the normal level, and grade V is defined as a fatality due to renal toxicity."|1 year|One patient experienced grade 5 renal toxicity||participants|||Number
130689|NCT00548717|Secondary|Donor Stem Cell Engraftment, Including Donor-host Hematopoietic Chimerism Studies Post Transplant|Engraftment of donor cells by week 4 after transplantation. Assessment of donor stem cell engraftment will include donor-host hematopoietic chimerism analyses at 4 weeks and every 3 months after transplantation. Chimerism measured from peripheral blood or from bone marrow.|30 days|||participants|||Number
130690|NCT00548717|Primary|To Determine the Rate of Grade II-IV Acute GVHD When Sirolimus and Mycophenolate Mofetil or Sirolimus, Mycophenolate Mofetil and Bortezomib is Used for GVHD Prophylaxis After Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies||150 days|||percentage of participants|||Number
130691|NCT00548691|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAE's)||from Day 0 through 30 days after the last dose of study drug|||participants|||Number
130692|NCT00548548|Secondary|Participants With Adverse Events|The intensity of Adverse Events (AEs) was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 on a five-point scale from Grade 1 (Mild) to Grade 5 (Death). A serious AE (SAE) was defined as any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|From randomization until 3 months after last dose (up to 26 months)|Safety population, including all patients randomized and exposed to study medication (defined as any one component of the combination). Patients are assigned to treatment groups based on the treatment they actually received.||participants|||Number
130693|NCT00548548|Secondary|Participants With Disease Control|Disease control for participants with measurable disease was defined as a complete response (CR), partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the RECIST criteria. For participants without measurable disease, disease control was defined as no disease progression for ≥ 6 weeks.|From randomization until the end of study, up to 26 months.|Intent-to-treat||participants|||Number
130733|NCT00548262|Secondary|Length of Stay in Intensive Care Unit (ICU)|Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.|Baseline up to Week 6 Follow-up|MITT; N=number of participants evaluable for length of time in ICU.||Days||95% Confidence Interval|Median
131507|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
130694|NCT00548548|Secondary|Duration of Response|Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. Median duration of response was estimated using the Kaplan-Meier method.|From randomization to the end of study, up to 26 months|Participants with measurable disease at baseline who had a best overall response of complete response or partial response, and for whom duration of response data was available.||months||95% Confidence Interval|Median
130695|NCT00548548|Secondary|Participants With a Best Overall Response of Complete or Partial Response|Best overall response during first-line therapy is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response, as determined by the RECIST criteria. CR is defined as the disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions and no new or progression of non-target lesions, or the disappearance of all target lesions and persistence of one or more non-target lesion(s).|From randomization until the end of study, up to 26 months.|Measurable Disease Population, including all randomized participants with measurable disease (per RECIST) for gastric cancer at baseline. Patients were analyzed according to the treatment groups to which they were randomized.||participants|||Number
130696|NCT00548548|Secondary|Time to Disease Progression|Time to progression is defined as the time from randomization to the first occurrence of progressive disease (PD). PD was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Patients with no PD at study completion (including those who died before PD) were censored at the date of the last tumor assessment. Median time to PD was estimated using the Kaplan-Meier method.|From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months.|Intent-to-treat||months||95% Confidence Interval|Median
130697|NCT00548548|Secondary|Progression-free Survival During First-line Therapy|Progression-free survival (PFS) during first-line therapy is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first and only if it occurs no later than 28 days after last confirmed intake of any study medication and only if it occurs before the start of non-study antineoplastic treatment. Participants who did not progress or die in this interval or were lost to follow-up were censored at the date of the last tumor assessment within this time window. Median PFS was estimated using the Kaplan-Meier method.|From randomization until 28-days after the last study treatment was administered, up to 26 months.|Intent-to treat.||months||95% Confidence Interval|Median
130698|NCT00548548|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method.|From randomization until disease progression or death, up to 26 months.|Intent to treat||months||95% Confidence Interval|Median
130699|NCT00548548|Primary|Overall Survival|The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.|From randomization until death, up to 26 months|The Intent-to-Treat population, including all randomized participants.||months||95% Confidence Interval|Median
130700|NCT00547456|Primary|Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.||4 weeks|The assay used did not work, as a result, no data for any Outcome Measures was collected. The trial is closed and completed.|||||
130701|NCT00547365|Primary|Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)|Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.|Up to 1 year|Two of ten patients with AL cardiac involvement who received IGIV infusions were analyzed (other eight individuals were removed from study before completion due to death/conditions unrelated to IGIV, loss to follow-up, or physician decision).||participants with positive response|||Number
130702|NCT00547365|Primary|Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One Infusion of IGIV.||Up to 1 year|All patients who had at least one infusion of human immune globulin intravenous.||events|||Number
130703|NCT00548431|Secondary|Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production|Biweekly bloodsamples during the 3 months are analyzed for 6TGN incorporation into leucocyte DNA. In addition Methylated Mercaptopurine (MeMP) and Erythrocyte-Methotrexate level is measured|During the 3 months consolidation therapy||02/2018||||
130704|NCT00548431|Primary|Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported|Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.|3 months ( 79 days )|||Participants|||Number
130705|NCT00548418|Secondary|Correlate Hypoxia Inducible Factor 1 (HIF-1) and Hypoxia Induced Gene Expression as Measured by Laboratory Studies||When specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.|||||
130706|NCT00548418|Secondary|Correlate Patterns of Gene Expression as Assessed by Microarrays||Correlative studies when specimens available|None of the correlative studies were performed as the investigator and institution which originally offered to do those assays actually did not participate in accrual to this study. We also did not collect specimens on all patients entered on study.|||||
130707|NCT00548418|Secondary|Frequency of Response as Measured by RECIST Criteria (Imaging)|"RECIST criteria:~Complete response is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Progression is defined as ANY of the following - 20% increase in the sum of LD target lesions, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease, progression of existing non-target lesions~Stable disease is any condition not meeting the above criteria"|Tumor response measured prior to every other cycle of therapy (range of follow-up to measure overall response was 1.6-9.5 months)|26 participants were evaluable for response.||participants|||Number
130708|NCT00548418|Secondary|Overall Survival|Defined as time from study entry until death from any cause or date of last contaqct.|Until death (follow-up ranged from 1.7 months to 33.4 months)|||months||90% Confidence Interval|Median
130709|NCT00548418|Primary|Anti-tumor Activity as Measured by Surviving Progression-free|Defined as the period from study entry until documentation of disease progression, death, or date of last contact, whichever occurred first.|Progression-free survival at 6 months|||percentage of participants|||Number
130710|NCT00548405|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||percent change||Standard Deviation|Mean
130711|NCT00548405|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||Z-score||Standard Deviation|Mean
130712|NCT00548405|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||units on a scale||Standard Deviation|Mean
130713|NCT00548405|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||percentage of participants||95% Confidence Interval|Number
130714|NCT00548405|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.||relapses per participant per year||95% Confidence Interval|Number
130715|NCT00548405|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.||percentage of participants||95% Confidence Interval|Number
130734|NCT00548262|Secondary|Length of Hospital Stay|Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.|Baseline to Week 6 Follow-up|MITT; data not summarized using descriptive statistics.||days|||Number
131508|NCT00541658|Secondary|Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population||Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
130716|NCT00548340|Post-Hoc|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 22 and 29. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.||minutes||Standard Error|Mean
130717|NCT00548340|Post-Hoc|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline, and the average of nights 22 and 29.|Baseline, Night 22, and Night 29 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.||minutes||Standard Error|Mean
130718|NCT00548340|Secondary|Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST)|Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurements for WASO and TST|One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.||minutes||Standard Error|Mean
130719|NCT00548340|Primary|Average Change From Baseline - Latency to Persistent Sleep (LPS)|Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.|Baseline, Night 1, and Night 8 measurement|One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.||minutes||Standard Error|Mean
130720|NCT00548327|Other Pre-specified|Blood Plasma Concentration of Atomoxetine|Blood for drug plasma levels is obtained before and 3 hours after dosing on the 14th day receiving Atomoxetine.|before and 3 hours after dosing on the 14th day receiving Atomoxetine|Data were not collected for analysis because the study was terminated before target accrual|||||
130721|NCT00548327|Secondary|Change in The Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a psychological questionnaire to rate the severity of anxiety.It contains 14 symptom-oriented questions.Each of these symptoms is given a severity rating, from not present(scored as 0)to very severe(scored as 4)|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual|||||
130722|NCT00548327|Secondary|Change in The Profile of Mood States|The Profile of Mood States is an instrument that provides a rapid method of assessing transient, fluctuating mood states. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1)tension-anxiety, 2)depression-dejection, 3)anger-hostility, 4)fatigue-inertia, 5)vigor-activity and 6)Confusion-bewilderment.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual|||||
130723|NCT00548327|Primary|Changes in Cognitive Function Measured by Neuropsychological Testing|Neuropsychological testing consists of a battery of 10-12 individual tests to measure cognitive function. We expect both a drug effect and a genotype effect on neuropsychological tasks that measure dorsolateral prefrontal cortex (DLPFC) executive function, mostly in individuals who share the val/val genotype with respect to the met/met genotype.|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual|||||
130724|NCT00548327|Secondary|Change in The Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a 7-point rating scale with (1) indicating the absence of a symptom or behavior and (7) indicating the most severe symptom. The PANSS includes three scales(Positive and Negative Syndromes and General Psychopathology)and five clusters (Anergia, Thought Disturbance, Activation, Paranoid/Belligerence and Depression.|At 14th and 35th days|Data were not collected for analysis because the study was terminated before target accrual|||||
130725|NCT00548327|Primary|Changes in Functional Magnetic Resonance Imaging (fMRI) Blood-oxygen-level-dependent (Bold) Activity|"Main outcome measures were BOLD fMRI response (activation) while performing a prefrontal cortex-dependent task such as N-Back Working Memory with increasing levels of task difficulty. It was expected to have a greater level of activation in BOLD fMRI in schizophrenic patients with respect to normal volunteers, and a greater activation in individuals (either normal volunteers or patients) who share the val/val genotype with respect to the met/met genotype.~Based on prior fMRI studies and on power analysis of neuropsychological variables, at least 28 and 26 subjects are respectively needed to achieve significant power in functional neuroimaging and neuropsychological studies.These sizes provide an 80% power to observe significant differences between drug conditions at the 0.05 level."|2 hours after the first or the second dose of Atomoxetine or placebo on 14th day|Data were not collected for analysis because the study was terminated before target accrual|||||
130726|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)|Chemistry laboratory test data measured as international units per (IU/L).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.||IU/L||Full Range|Median
130727|NCT00548262|Secondary|Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)|Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).|Baseline to Week 2 Follow-up|Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.||mg/dL||Full Range|Median
130728|NCT00548262|Secondary|Change From Baseline in Vital Signs: Respiration Rate|Respiration rate measured as respirations per minute (resp/min).|Baseline to Week 2 Follow-up|Safety analysis population||resp/min||Full Range|Median
130729|NCT00548262|Secondary|Change From Baseline in Vital Signs: Temperature|Temperature measured as degrees of Celsius (C).|Baseline to Week 2 Follow-up|Safety analysis population||Degrees of Celsius||Full Range|Median
130735|NCT00548262|Secondary|Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment|Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.|Baseline to Day 42|Safety analysis set: all participants who received any dose of study medication.||days||Full Range|Median
130736|NCT00548262|Secondary|Time to Negative Blood, Specimen, or Tissue Culture|Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).|Baseline to Week 2 Follow-up|MITT; data not summarized using descriptive statistics.||Days|||Number
130737|NCT00548262|Secondary|Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis|"Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded disease under study as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone."|Baseline to Week 6 Follow-up|MITT. MITT. Death for 1 participant reported twice in this study(recorded at End of Treatment and at End of Study); both instances are reported in this table under Attributal Death=No.||participants|||Number
130738|NCT00548262|Secondary|Number of Participants Per Survival Status (Alive or Dead) on Day 30||Day 30|MITT||participants|||Number
130739|NCT00548262|Secondary|Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.|EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
130740|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, Week 2 Follow-up (F/U)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data insufficient for analysis by status=elderly >65 years of age; not summarized.||participants|||Number
130741|NCT00548262|Secondary|Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|EIVT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly >65 years of age; not summarized.||participants|||Number
130742|NCT00548262|Secondary|Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.|Baseline, EOT (up to Day 42)|MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly (>65 years of age); not summarized.||participants|||Number
130743|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, Week 2 Follow-up|MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure.||participants|||Number
130744|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EOT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
130809|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
130745|NCT00548262|Secondary|Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT|Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.|Baseline, EIVT (up to Day 42)|MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
130746|NCT00548262|Secondary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up|MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure.||participants|||Number
130747|NCT00548262|Primary|Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment|Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).|End of Treatment (EOT) (up to Day 42)|Modified Intent-to-Treat population (MITT): all Intent-to-Treat (ITT) participants (took at least 1 dose of study treatment) and with a positive baseline culture for a Candida spp within 96 hours before entry into the study. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure.||participants|||Number
130748|NCT00548249|Secondary|Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.||two separate sessions measured one week apart.|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||Subjects|||Number
130749|NCT00548249|Secondary|Estimate the Amount of SFP Transferred From the Dialysate to the Blood During a Dialysis Session.||At each dialysis session for up to 26 weeks||||||
130750|NCT00548249|Secondary|Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.||At each dialysis session for up to 26 weeks|||Subjects|||Number
130751|NCT00548249|Secondary|Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.|Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).|Every 4 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||pg||Standard Deviation|Mean
130752|NCT00548249|Secondary|Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.|Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL|Up to 26 weeks|"Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication.~Because of the small number of patients reaching the endpoint of decrease in Hgb >= 1.0 g/dL, the Kaplan-Meier analysis could not estimate the number of days for at least one treatment group for the 50th percentile and higher."||Days|||Number
130753|NCT00548249|Secondary|Change From Baseline in Hemoglobin (Hgb)||two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||grams/ deciliter (g/dL)||Standard Deviation|Mean
130754|NCT00548249|Primary|Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.|Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).|up to 26 weeks|Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication||Percent of subjects|||Number
130755|NCT00548184|Secondary|Data Analysis of the Biomarkers: Immunohistochemical Staining of Cells From Breast Biopsies and Skin Biopsies Will be Performed.||one year||||||
130756|NCT00548184|Primary|Pathologic Assessment After Study Treatment|Pathologic Assessment After 12 weeks of lapatinib and trastuzumab with or without endocrine therapy. Pathologic complete response: no invasive cancer in the residual breast. Near pathologic complete response: residual disease of less than 1 cm in breast.|12 weeks|65 patients were enrolled and received the study treatment. 1 patient was found ineligible for this study therefore she was excluded from outcome report.||participants|||Number
130757|NCT00548145|Secondary|MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)|Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)|baseline and 12 months||||||
130758|NCT00548145|Primary|Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)|Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.|baseline and 12 months|||scores on a scale||Standard Deviation|Mean
130759|NCT00548132|Secondary|Clinical Sepsis Episodes/Per 1000 Catheter Days|This measure is a combination of patients with positive blood cultures (BSI) and patients who had signs and symptoms of sepsis but with negative blood cultures. These patients still required treatment with antibiotics.|2 years|||sepsis episodes/1000 catheter days|||Number
130760|NCT00548132|Primary|The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms|The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization|2 years|Based on previous data (unpublished),there would be a 60% reduction in the incidence of bloodstream infections-- the primary outcome. The number of patients included in this study had a large enough sample size to show a statistical difference.||BSIs /1000 catheter days|||Number
130761|NCT00548041|Primary|Feasibility of Rapid HIV Testing in Emergency Department|Feasibility was assessed as number of participants who were approached and agreed to participate in rapid HIV testing and then had testing completed.|2 years|||participants|||Number
130762|NCT00547911|Secondary|Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Heart rate was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||BPM||Standard Error|Mean
130763|NCT00547911|Secondary|Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Diastolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||mmHg||Standard Error|Mean
130764|NCT00547911|Secondary|Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Systolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.|Up to 24 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||mmHg||Standard Error|Mean
130765|NCT00547911|Primary|Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma dihydroxyphenylglycol (DHPG) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
130766|NCT00547911|Primary|Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxymandelic acid (DHMA) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
130767|NCT00547911|Primary|Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma norepinephrine concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
130768|NCT00547911|Primary|Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone|Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations.|Up to 48 hours after receiving drug(s)|Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.||nmol/L||Standard Error|Mean
130769|NCT00547157|Secondary|CRR by 6 Months - Central|CRR is Complete Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete Response (CR) is defined as disappearance of all index lesions.|From randomization till 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.||Proportion of Participants||95% Confidence Interval|Number
130770|NCT00547157|Secondary|ORR by 6 Months - Central|ORR is Objective Response Rate. Tumor assessments are based on central review of scans uisng a modification of the WHO criteria. Complete or partial response is considered as objective response.|From randomization to 6 months|Evaluable for Central Tumor Response Analysis Set: the subset of subjects in the Efficacy Analysis Set with at least one bi-dimensionally measurable leasion at baseline using a modification of the WHO criteria per blinded central review.||Proporation of Participants||95% Confidence Interval|Number
130771|NCT00547157|Secondary|Overall Survival|Time from first dose date to death|maximum follow up time 46.2 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
130772|NCT00547157|Secondary|Progression-free Survival|Time from first dose date till disease progression or death|maximum follow up time 46.2 months|Efficacy analysis set||months||95% Confidence Interval|Median
130773|NCT00547157|Secondary|Duration of Local Regional Control|Time from study day 1 to the date of first local-regional failure or to death due to any cause (whichever occurs first)|maximum follow up time 46.2 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
130810|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
130774|NCT00547157|Primary|Local Regional Control Rate at 2 Years|Kaplan-Meier estimate of Local regional control rate at 2 years. Local regional control rate will be measured according to the investigator’s assessment of disease status based on all available data (ie, from clinical examination, radiologic assessments, pathology reports, and autopsy reports).|from study day 1 to 2 years|Efficacy Analysis Set||Proportion of Participants||95% Confidence Interval|Number
130775|NCT00547118|Secondary|To Examine the Efficacy of Rimonabant for Patient Perceived Health Outcomes and Quality of Life (Secondary Outcome)||End of study||||||
130776|NCT00547118|Primary|To Examine the Efficacy of Rimonabant for Neurocognitive Impairments in People With Schizophrenia Treated With Second-generation Antipsychotics|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.|Baseline and End of study|14 (R n=7, P n=7) completed baseline and End Of Study (EOS), 16 wk. Neurocognitive assessments (i.e. RBANS); 1 P pt. failed to complete the other EOS neurocognitive tests. 5 R pts. and 4 P pts. completed the 16-wk. treatment phase; the other 2 R pts. completed 11 and 13 wks. and 3 P pts. completed 13 (n=2) and 15 wks. (n=1).||units on a scale||Standard Deviation|Mean
130777|NCT00547118|Primary|To Examine the Effects of Rimonabant on Food Satiety in People With Schizophrenia||End of study||||||
130778|NCT00547118|Primary|To Test the Effect of Rimonabant on Cigarette Smoking, Nicotine Dependence and Nicotine Craving in People With Schizophrenia||End of study||||||
130779|NCT00547118|Primary|To Examine the Safety and Tolerability of Rimonabant as an Adjunctive Agent for Decreasing Weight and Metabolic Risk in People With Schizophrenia||End of study||||||
130780|NCT00547118|Primary|To Examine the Efficacy of Rimonabant in Decreasing Weight and Metabolic Parameters/Cardiovascular Disease Risk in People With Schizophrenia Receiving Second Generation Antipsychotics||End of study||||||
130781|NCT00546910|Primary|Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
130782|NCT00546910|Primary|Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
130783|NCT00546910|Primary|Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8|Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
130784|NCT00546910|Secondary|Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8|Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||units on a scale||Standard Deviation|Mean
130785|NCT00546910|Secondary|Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8|CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||units on a scale||Standard Deviation|Mean
130786|NCT00546910|Secondary|Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 8 weeks|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||units on a scale||Standard Deviation|Mean
130811|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 AEs That Begin During Infusion or Within 72 Hours of Completion of Infusion||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
130787|NCT00546910|Primary|Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8|Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.|Baseline, 8 weeks (W8)|Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.||Q-scores||Standard Deviation|Mean
130788|NCT00546897|Secondary|Plasma Proteins Via Proteomics|Proteomic analysis will be performed within the Siteman Cancer Center proteomics core on pre- and post-treatment plasma samples. This pilot proteomic study will identify candidate proteins of interest with altered expression after treatment with lenalidomide. This approach will provide an unbiased method to assess global changes in serum proteins following lenalidomide therapy.|Pre and post treatment|This outcome was not analyzed for either Cohort due to sample collection.|||||
130789|NCT00546897|Secondary|Gene Expression Profiles of Bone Marrow and Peripheral Blood|RNA will be made from total bone marrow cells for labeling and evaluations by RNA profiling. Cellular RNA and corresponding biotinylated cRNA targets will be prepared and hybridized with Affymetrix GeneChip® microarrays within the Multiplexed Gene Analysis SCC Core (Dr. Mark Watson, Director). Microarray data (and eventually corresponding gene sequence data) will be integrated an analyzed with state-of-the-art software packages. The pre- and post-treatment RNA profiling studies will be used as a discovery tool. Patterns of gene expression before and after lenalidomide therapy will be compared within each patient’s sample to identify genes with altered expression after lenalidomide therapy. In addition, supervised algorithms will be sued to identify genes that can potentially predict clinical outcome and response to lenalidomide therapy.|Pre and post treatment|This outcome measure was not analyzed for either Cohort due to sample collection.|||||
130790|NCT00546897|Secondary|Changes in NK Cell Number and Function|Peripheral blood mononuclear cells (PBMC) will be viably cryopreserved from patients at baseline (pre-therapy, newly diagnosed AML), during lenalidomide therapy, and posttherapy. Following sample collection, PBMC will be thawed, and flow cytometry will be performed to assess NK cell number (CD56+CD3-), subsets, and phenotype utilizing the Siteman Cancer Center Flow Cytometry / Cell Sorting Core. In addition, NK cell function will be assessed in flow based killing assays using PBMC (containing NK cells) as effectors and NK sensitive cell lines (K562) and/or autologous leukemic blasts as target cells. Thus, analyzing these parameters in patients before, during, and after therapy will provide a comprehensive evaluation of the ability of lenalidomide to modulate NK cells in patients in vivo.|Baseline, during therapy, and posttherapy|This outcome was not analyzed for either Cohort due to number of samples collected.|||||
130791|NCT00546897|Secondary|Duration of CR for Complete Responders|Duration of remission: Defined as the interval from the date complete remission is documented to the date of recurrence|2 years|Participants in Cohort 1 were not analyzed for duration of remission because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||Full Range|Median
130792|NCT00546897|Secondary|Relapse Free Survival (RFS) for Complete Responders|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|2 years|Participants in Cohort 1 were not analyzed for relapse free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||95% Confidence Interval|Median
130793|NCT00546897|Secondary|Progression-free Survival|Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment. It is the percentage of individuals in the group whose disease is likely to remain stable (and not show signs of progression) after a specified duration of time. Progression-free survival rates are an indication of how effective a particular treatment is.|2 years|Participants in Cohort 1 were not analyzed for progression-free survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||95% Confidence Interval|Median
130794|NCT00546897|Secondary|Event Free Survival (EFS)|Event free survival: Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|2 years|Event free survival was not analyzed. Progression free survival was analyzed instead.|||||
130795|NCT00546897|Secondary|Overall Survival (OS)|Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.|2 years|Participants in Cohort 1 were not analyzed for overall survival because it was determined the treatment design did not work. 8 out of 15 participants did not receive the 2 high dose lenalidomide cycles and 9 out of 15 participants did not receive any of the low dose lenalidomide cycles due to progressive disease.||months||95% Confidence Interval|Median
130796|NCT00546897|Secondary|Partial Remission Rate (PR)|Partial remission (PR): Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
130797|NCT00546897|Secondary|CR With Complete Blood Counts (CRi) Rate|CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
130798|NCT00546897|Secondary|Cytogenetics CR Rate (CRc)|Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
130799|NCT00546897|Secondary|Morphologic Complete Remission Rate (CRm)|CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
130800|NCT00546897|Secondary|Morphologic Leukemia Free State|Morphologic leukemia-free state: Defined as < 5% blasts on the BM aspirate with spicules and a count of > 200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
130801|NCT00546897|Secondary|Response Rate (RR)|"RR = as patients obtaining any response (CRm + CRc +CRi + PR).~CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRc = Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Partial remission (PR): Requires"|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
130802|NCT00546897|Secondary|Safety and Tolerability (Removal From Study Due to Adverse Events)|Toxicity will be scored using CTCAE Version 3.0 for toxicity and adverse event reporting|4 weeks after last dose of study drug [median duration of therapy was 65 days (range, 3-413 days)]|||participants|||Number
130803|NCT00546897|Primary|Complete Remission Rate (CRm + CRi + CRc)|"CRm = Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count >100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.~CRi = Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.~Cytogenetic complete remission (CRc): Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells)."|After 2 cycles of low dose lenalidomide (approximately Day 113 for Cohort 1 and approximately Day 104 for Cohort 2)|"9 out of 15 participants did not receive the two low dose cycles of lenalidomide in Cohort 1.~23 out of 33 participants did not receive the two low dose cycles of lenalidomide in Cohort 2."||participants|||Number
130804|NCT00546871|Secondary|Percentage of Infusions Associated With ≥1 Local AE Excluding Infections That Begin During Infusion or Within 72 Hours of Completion of Infusion.||During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Percentage of infusions|Participants||Number
130805|NCT00546871|Primary|Percentage of Infusions in SESC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)||Percentage of Infusions|Participants|95% Confidence Interval|Number
130806|NCT00546871|Primary|Percentage of Infusions in SNSC for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)||Percentage of Infusions|Participants|95% Confidence Interval|Number
130807|NCT00546871|Primary|Percentage of Infusions in FSDS for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of infusions for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)||Percentage of Infusions|Participants|95% Confidence Interval|Number
130808|NCT00546871|Primary|Percentage of Participants With Prior Experience With Subcutaneous Administration of Immunoglobulins (SESC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SESC data set (all participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug)||Percentage of Participants|||Number
130813|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts||AEs per infusion|||Number
130814|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SESC)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants with prior experience with subcutaneous administration of immunoglobulins who received any study drug during each of the study parts||Adverse events|||Number
130815|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC- All Ages)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts||AEs per infusion|||Number
130816|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (SNSC -All Ages)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|Study participants who are naïve to SC administration of immunoglobulins and received any study drug during each of the study parts||Adverse events|||Number
130817|NCT00546871|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR~Rate of AEs defined as the number of AEs categorized by MedDRA preferred terms, seriousness, severity, and causality divided by the number of infusions."|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts||AEs per infusion|||Number
130818|NCT00546871|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Severity, and Causality (FSDS)|"Seriousness and causality are abbreviated below as:~Seriousness: Serious Adverse Event= SAE, non-Serious Adverse Event= non-SAE Causality: possibly or probably related= R, not related= NR"|Throughout entire study (1 year and 9 months)|All study participants who received any study drug during each of the study parts||Adverse events|||Number
130819|NCT00546871|Primary|Percentage of Participants Naïve to SC Administration of Immunoglobulins (SNSC) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped.|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|SNSC data set (all participants naïve to SC administration of immunoglobulins who received any study drug)||Percentage of Participants|||Number
130820|NCT00546871|Secondary|Proportion of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|Proportion of Participants Reporting 1 or More Moderate or Severe AEs That Begin During Infusion or Within 72 Hours of Completion of an Infusion.|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||Proportion of participants|||Number
130821|NCT00546871|Secondary|Frequency of Dose Adjustments (If IgG Trough Levels <4.5 g/L)|"Frequency of Dose Adjustments Based on IgG Trough Levels <4.5 g/L IgG, if Any, for Each Study Part.~Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set."|Throughout the study period (1 year and 9 months)|All participants who received any study drug||ratio|||Number
130822|NCT00546871|Secondary|AEs Deemed/Judged to be Related by the Investigator|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug that occur at any time during the study divided by the total number of infusions.|Throughout the study period (1 year and 9 months)|All participants who received any study drug||AEs per infusion|Participants||Number
130823|NCT00546871|Secondary|Rate of Temporally Associated AEs Per Infusion|Rate of AEs per infusion defined as the total number of all AEs that begin during infusion or within 72 hours of completion of an infusion (“temporally associated”) divided by the total number of infusions.|During Infusion or Within 72 Hours of Completion of Infusions|All participants who received any study drug||AEs per infusion|Participants||Number
130824|NCT00546871|Secondary|Annual Rate of Acute Serious Bacterial Infections During IV and SC Treatment (FSDS)|Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with an allowance for overdispersion by the deviance method.|Throughout the study, 1 year and 9 months|Full Safety Data Set (All study participants who received any infusions)||Estimated infections/year|||Number
130825|NCT00546871|Secondary|Annual Infection Rates During Treatment|Annual rate of all infections calculated using a Poisson model to account for different lengths of observation per subject using SAS V9.1.3 procedure GENMOD with allowance for overdispersion by deviance method. Point estimates and likelihood-ratio based 95% confidence intervals were provided. Infections as included in analysis comprised all reported AEs that were coded to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of infections and infestations, described as an infection by investigator, or for which anti-infective medication was prescribed.|Throughout the study, 1 year and 9 months|Full safety data set (all participants who received any study drug)||Estimated infections per year||95% Confidence Interval|Mean
130856|NCT00546754|Secondary|Change in Uric Acid From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||umol/L||Standard Deviation|Mean
130826|NCT00546871|Secondary|Number of Anti-Measles Antibody Titers That Were Below or Above the Protective Titer Level|Antibody Titers That Were Below or Above the Protective Titer Level of >1:8 for IV and SC Treatment in Study Parts 1, 2, 3a and 3b. Participants had multiple anti-measles antibody titers measured during the study.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All study participants||Antibody titers|Participants||Number
130827|NCT00546871|Secondary|Trough Levels of Antibody to Tetanus In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results||IU/mL||95% Confidence Interval|Median
130828|NCT00546871|Primary|Percentage of Participants in Full Safety Data Set (FSDS) Who Had Any Infusion for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped|Ability to tolerate IGIV, 10% administered IV or SC. Measured as the percentage of participants for which the infusion rate was reduced at any infusion and/or the infusion was interrupted or stopped for (i) any reason and (ii) for tolerability concerns or AEs|Throughout study (1 year and 9 months)|Full safety data set (all participants who received any study drug)||Percentage of Participants|||Number
130829|NCT00546871|Secondary|Trough Levels of Antibody to Hepatitis B in All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results||mIU/mL||95% Confidence Interval|Median
130830|NCT00546871|Secondary|Trough Levels of Antibody to Haemophilus Influenzae In All Study Participants|Trough levels for IV and SC Treatment in Study Parts 1, 2, 3a and 3b.|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visit 1 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; at Visit 1 in the Study Extension Part; and at the end-of-study evaluation|All participants with specific antibody test results||µg/mL||95% Confidence Interval|Median
130831|NCT00546871|Secondary|Trough Levels of IgG After Administration of IGIV, 10%, in Participants 12 Years and Older|"Part 1: IgG trough levels measured at each IV infusion day (every 3rd or 4th week depending on schedule/frequency of participants for a total of 12 weeks)~Part 2: IgG trough levels measured at weeks 1, 5 and 9 (of a total of 12 weeks)~Part 3a: IgG trough levels measured at weeks 1 and 5 (of a total of 6 weeks)~Part 3b: IgG trough levels measured at weeks 1, 5, 9 and 12 (of a total of 12 weeks)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants who received any study drug), 12 Years and Older||g/L||95% Confidence Interval|Median
130832|NCT00546871|Secondary|Study Part 3B: Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||mL/kg/day||95% Confidence Interval|Median
130833|NCT00546871|Secondary|Study Part 3B: Area Under the Curve (AUC)|The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Study Parts 1, 2 and 3b, AUC(0-τ) was standardized for the infusion intervals (3 or 4 weeks vs. 1 week).|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||g*days/L||95% Confidence Interval|Median
130834|NCT00546871|Secondary|Study Part 3B: Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
130835|NCT00546871|Secondary|Study Part 3B: Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||days||95% Confidence Interval|Median
130836|NCT00546871|Secondary|Study Part 3B: Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
130837|NCT00546871|Secondary|Study Part 2 (SC): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||mL/kg/day||95% Confidence Interval|Median
130838|NCT00546871|Secondary|Study Part 2 (SC): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
130839|NCT00546871|Secondary|Study Part 2 (SC): Time to Maximum Immune Globulin Concentration (T-max)|Time to reach C-max|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||days||95% Confidence Interval|Median
130989|NCT00546117|Secondary|Tympanometry||2 months||||||
130990|NCT00546117|Secondary|Acoustic Reflectometry||2 months||||||
130840|NCT00546871|Secondary|Study Part 2 (Subcutaneous (SC)): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #8 starts) up to 7 days (+/-1 day) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the Day 7 measurements~≥2 measurements for Days 1, 3, and 5"||g/L||95% Confidence Interval|Median
130841|NCT00546871|Secondary|Study Part 1 (IV): Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50%during the terminal phase.|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||days||95% Confidence Interval|Median
130842|NCT00546871|Secondary|Study Part 1 (IV): Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||mL/kg/day||95% Confidence Interval|Median
130843|NCT00546871|Secondary|Study Part 1 (IV): Minimum Plasma Concentration (C-min)|Minimal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||g/L||95% Confidence Interval|Median
130844|NCT00546871|Secondary|Study Part 1 (IV): Maximum Plasma Concentration (C-max)|Maximal immune globulin concentration after infusion|Pharmacokinetic evaluations: 60 minutes pre-infusion (before infusion #3 starts) up to 28 days (+/-2 days) post-infusion.|"Participants for whom the following PK measurements are available:~pre-infusion and the 30-minute-post-infusion measurements~≥3 measurements for Days 1, 4, 9, 14, and 21 and/or 28~for the 3-week treatment schedule: Day 14 and/or the Day 21 measurement(s); for the 4-week treatment schedule: Day 21 and/or the Day 28 measurement(s)"||g/L||95% Confidence Interval|Median
130845|NCT00546871|Primary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10%, in Participants Aged 2 to <12 Years.|"Administration of IGIV, 10%:~Part 1 = IV administration (IV)~Parts 2, 3a, 3b = SC administration (SC)"|Baseline; at each 3 or 4-week study visit in Study Part 1; at Visits 1, 5, and 9 in Study Part 2; at Visits 1, and 5 in Study Part 3a; at Visits 1, 5, and 9 in Study Part 3b; and at the end-of-study evaluation|Full safety data set (all participants, aged 2 to <12 years who received any study drug)||g/L||95% Confidence Interval|Median
130846|NCT00546871|Primary|Ratio of Area Under the Concentration Curve (AUC 0-τ)/Week Following IV Administration to SC Administration of IGIV, 10% at an Adjusted/Individual Adapted Dose (Part 3b), Expressed as a Percentage|Expressed as (AUC_SC/AUC_IV) * 100|Week 12 (IV) and week 32 or 33 (SC)|Participants, ≥12 years, with PK data in terms of AUC[0-τ]/week following IV administration and SC administration of IGIV, 10% at an adjusted/individually adapted dose in Study Part 3b||percent||90% Confidence Interval|Number
130847|NCT00546819|Secondary|Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.|The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.||Ratio||95% Confidence Interval|Mean
130848|NCT00546819|Secondary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination|The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).|42 days postvaccination|Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.||gpELISA units/mL||95% Confidence Interval|Mean
130849|NCT00546819|Primary|Number of Participants With Serious Adverse Events (SAE)|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Up to 182 days postvaccination|"All participants who were vaccinated and had any safety~follow-up were included in the safety analysis."||Participants|||Number
130850|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma–GT) From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 254 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||IU/L||Standard Deviation|Mean
130851|NCT00546754|Secondary|Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 300 and 273 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||IU/L||Standard Deviation|Mean
130852|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 255 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||umol/L||Standard Deviation|Mean
130853|NCT00546754|Secondary|Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mg/L||Standard Deviation|Mean
130857|NCT00546754|Secondary|Time to Achieve Target Blood Pressure|Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)|12 weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||Days||Standard Deviation|Mean
130858|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 12|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12|12 Weeks|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||Patients|||Number
130859|NCT00546754|Primary|Change in Systolic Blood Pressure From Baseline to Week 12||Baseline and Week 12|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
130860|NCT00546754|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6|Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||Patients|||Number
130861|NCT00546754|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
130862|NCT00546754|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||Baseline and Week 6|416 and 373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively||mm Hg||Standard Deviation|Mean
130863|NCT00546728|Primary|Change in Reactive Hyperemic Index Over the 3-month Treatment Period|Change in reactive hyperemic index over the 3-month treatment period, which is a measure of endothelial (inner lining of blood vessels) function. This is measured as a ratio of post-occlusion blood flow volume versus baseline blood flow volume in fingertips. Higher ratio values are considered indicative of better arterial health.|Change from baseline to 3 months|All completers were included in the analysis||ratio||Standard Deviation|Mean
130864|NCT00546715|Secondary|Change From Baseline in Blood Pressure to Day 7 or Discharge|Changes in blood pressure from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement.|Baseline (Day 1), Day 7 or Discharge|||mmHg||Standard Deviation|Mean
130865|NCT00546715|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters (PR, QRS, QT, and QTc Intervals) to Day 7 or Discharge|The ECG was recorded after the participant was in a supine position for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. QTc was defined as corrected QT interval at a heart rate of 60 bpm. QTc was estimated using Bazett’s formula and Fredericia’s formula.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.||msec||Standard Deviation|Mean
130866|NCT00546715|Secondary|Change From Baseline in Heart Rate to Day 7 or Discharge|Changes in heart rate from baseline were measured after the participants were supine for at least 5 minutes. Baseline was defined as the Day 1 pre-dose measurement. The normal heart rate lies between 60-90 beats per minute (bpm), below 60 bpm and above 90 bpm were considered as bradycardia and tachycardia, respectively.|Baseline (Day 1), Day 7 or Discharge|The analysis was performed in the safety population.||bpm||Standard Deviation|Mean
130867|NCT00546715|Secondary|Time to Reach Maximum Decline in Plasma Hepatitis C Virus RNA Levels From Baseline|Participants were assessed for time to reach maximum decrease in log10 hepatitis C virus RNA level. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the PD population defined as participants who received at least one dose of study medication with available valid data.||hours||Standard Deviation|Mean
130868|NCT00546715|Secondary|Decline From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The Roche TaqMan HCV quantitative assay was used for analysis with detection limit of 10 IU/mL. Positive value indicated reduction from baseline in HCV RNA while negative value indicated an increase from baseline in HCV RNA. Baseline HCV RNA was defined as the pre-dose value on Day 1 log10 HCV RNA.|Pre-dose, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 144 hours post-dose on Day 1|The analysis was performed in the pharmacodynamic (PD) population defined as participants who received at least one dose of study medication with available valid data.||log IU/mL||Standard Deviation|Mean
130869|NCT00546715|Secondary|Apparent Total Body Clearance (CLT/F)|Apparent total body clearance (CLT/F) was calculated as Dose/AUC(INF), where CLT was the clearance of the drug and F was the absolute oral bioavailability. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||mL/min||Geometric Coefficient of Variation|Geometric Mean
130870|NCT00546715|Secondary|Plasma Half-life (T-half)|Plasma half-life was defined as the time required for one half of the total amount of administered drug eliminated from the body. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||hours||Standard Deviation|Mean
130991|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear||2 months|||participants|||Number
130992|NCT00546104|Secondary|To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption|Not assessed secondary to limited number of subjects.|not assessed||||||
130871|NCT00546715|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax was defined as the time required to reach maximum observed plasma concentration. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||hours||Full Range|Median
130872|NCT00546715|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]), Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. It was calculated as the sum of linear trapezoids using non-compartmental analysis. Area under the plasma concentration-time curve from time zero extrapolated to infinite time was estimated as sum of AUC(0-T) and the extrapolated area, computed by the quotient of the last observable concentration and λ, where λ was the slopes of the terminal phases of the plasma concentration-time profiles. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the PK set population.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
130873|NCT00546715|Secondary|Maximum Observed Plasma Concentration (Cmax) and Observed Plasma Concentration at 12 Hours (C-12) and 24 Hours (C-24)|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. C-12 and C-24 were defined as observed plasma concentration of daclatasvir at 12 hours and 24 hours, respectively. The plasma samples were analyzed for daclatasvir using a validated liquid chromatography-tandem mass spectrometric assay.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 and 72 hours post-dosing on Day 1|The analysis was performed in the pharmacokinetic (PK) set population defined as all participants who received at least single dose of daclatasvir with available valid data.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
130874|NCT00546715|Primary|Number of Participants With Marked Abnormalities in Laboratory Findings|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*pre-treatment value, Leukocytes (low) as <0.9*lower limit of normal, Aspartate Aminotransferase (high) as >1.25*upper limit of normal, Creatinine (high) as >1.33*pre-treatment value, Bicarbonate (high) as >1.2*upper limit of normal, Total Protein (high) as >1.1*upper limit of normal, Creatinine Kinase (high) as >1.5*upper limit of normal, Blood in Urine (high) as ≥ 2*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests.|Day 1 up to Day 7|The analysis was performed in the safety population.||participants|||Number
130875|NCT00546715|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements and Physical Examination Findings|Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion.|Day 1 up to Day 7 or Discharge|The analysis was performed in the safety population.||participants|||Number
130876|NCT00546715|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding) or disease which either occurs during study, whether or not related to the study drug. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 up to Day 7 for non-SAEs and Day 1 to 30 days after study discontinuation for SAEs|Analysis was performed in safety population defined as all participants who received any study drug treatment.||participants|||Number
130877|NCT00546637|Secondary|Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)|Number of participants experiencing serious and non-serious adverse events related to increased voiding difficulty (ie, Dysuria, Urinary retention regardless of catheterization, Urine flow decreased, Residual urine volume, Residual urine volume increased, Residual urine, and Urinary hesitation)|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.||participants|||Number
130878|NCT00546637|Secondary|Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)|Number of participants experiencing serious and non-serious adverse events of acute urinary retention requiring catheterization.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug.||participants|||Number
130879|NCT00546637|Secondary|Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12|Maximum urinary flow rate (Qmax) was recorded at Baseline and Week 12 visit.|Baseline, Week 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 12 (LOCF) were included in the analysis.||ml/sec||Full Range|Median
130880|NCT00546637|Secondary|Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12|Post-void residual volume measurement was measured by an ultrasound at Baseline, and at Weeks 4, 8 and 12.|Baseline, Week 4, 8 and 12|The safety analysis set included all subjects who took at least one dose of study drug. Subjects in the safety analysis set with non missing change from Baseline to Week 4, Week 8 (LOCF), or Week 12 (LOCF) were included in the analysis.||ml||Full Range|Median
130881|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)|The HRQL social interaction domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
131497|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
130882|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)|The HRQL sleep domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
130883|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)|The HRQL coping domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and Week 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
130884|NCT00546637|Secondary|Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)|The HRQL concern domain; range was 0-100. The transformed score for HRQL was calculated based on the following formula: Transformed score (HRQL) = [(Highest possible score – Actual raw score)/ Range]*100, where range was the raw score range. Positive change in HRQL Score indicates improvement.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
130885|NCT00546637|Secondary|Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12|HRQL domain and total raw score derived as sum of scores (6-point scale: 1 = not at all/none of the time; 6 = a very great deal/all of the time). Transformed score range 0 to 100 (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
130886|NCT00546637|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12|OAB-q is a self-administered, 33-item, validated questionnaire that assesses how much the subject has been bothered by selected bladder symptoms during the previous week. Each item rated by subject on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0-100. Once transformed, higher scores represent less favorable outcome.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
130887|NCT00546637|Secondary|Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).||participants|||Number
130888|NCT00546637|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4|Number of participants in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.||participants|||Number
130889|NCT00546637|Secondary|Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6–point scale: subject was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 12|FAS subjects with non-missing Baseline and Week 12 values (LOCF).||participants|||Number
130890|NCT00546637|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4|"PPBC: self-administered, single-item, validated questionnaire. Rated on a 6–point scale: subject was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. A post-baseline vs baseline variable with ordinal values was derived: 1=Deterioration=Difference in scores was positive; 2=No Change=Difference in scores was 0; 3=Minor Improvement=Difference in scores was -1; 4=Major Improvement=Difference in scores was ≤ 2."|Baseline, Week 4|FAS subjects with non-missing Baseline and Week 4 values.||participants|||Number
130891|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 12|FAS subjects with non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
130892|NCT00546637|Secondary|Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4|FAS subjects with non-missing change from Baseline to Week 4 were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
131498|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
130893|NCT00546637|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Score of Q8 range = 0-5 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
130894|NCT00546637|Secondary|Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q1, Q3, Q5, and Q6 range = 0-20 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
130895|NCT00546637|Secondary|Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5. Total IPSS range = 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Sum of Q2, Q4, and Q7 range = 0-15 points.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on scale||Standard Error|Least Squares Mean
130896|NCT00546637|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12|The IPSS Total Score is obtained by combining the scores of the responses to 1 though 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||scores on a scale||Standard Error|Least Squares Mean
130897|NCT00546637|Secondary|Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12|The USS sum rating was defined as the total of USS ratings recorded for all micturitions over the course of a day in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. USS Sum rating per 24 hours was calculated as the mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit.|Baseline, Week 4 and 12|FAS subjects with non-missing change from Baseline (LOCF) were included in the analysis.||USS Sum rating per 24 hours||Standard Error|Least Squares Mean
130898|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
130899|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes were defined as micturition-related urgency episodes with USS ratings 3-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of episodes||Standard Error|Least Squares Mean
130900|NCT00546637|Secondary|Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition-related urgency episodes are defined as those with a USS rating ≥4 marked for the corresponding micturition in the bladder diary. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Severe Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
130901|NCT00546637|Secondary|Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|Severe micturition related urgency episodes were defined as those micturitions with USS rating >=4 marked for the corresponding micturition in the diary. USS: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of episodes||Full Range|Median
130902|NCT00546637|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12|UUI episodes are defined as those micturitions with a USS rating of 5 in the bladder diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (UUI Episodes at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
130903|NCT00546637|Secondary|Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those micturitions with USS rating of 5 in the diary in subjects with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and Week 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of episodes||Full Range|Median
130993|NCT00546104|Secondary|To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression.|Spearman's correlation between the change in SRC signature from baseline to 4 weeks and time to progression|Baseline Src measure to first progression|11 patients had both change in Src level and progression time intervals||correlation coefficient|||Number
130904|NCT00546637|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Nocturnal micturitions at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
130905|NCT00546637|Secondary|Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the subject went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of micturitions||Standard Error|Least Squares Mean
130906|NCT00546637|Secondary|Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as: 100* (Micturitions at Week 4 or 12 – Baseline)/Baseline|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
130907|NCT00546637|Secondary|Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|All micturitions with USS rating 1 to 5. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Numeric change of micturitions per 24 hours at Week 4 and 12 relative to Baseline.|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||number of micturitions||Standard Error|Least Squares Mean
130908|NCT00546637|Secondary|Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12|"Micturition-related urgency episodes per 24 hours were defined as those with USS Scale rating of >= 3 marked for the corresponding micturition in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The percentage change at Week 4 or 12 was calculated as:~100* (Micturition-Related Urgency Episodes at Week 4 or 12 – Baseline)/Baseline"|Baseline, Week 4 and 12|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 or Week 12 (LOCF) were included in the analysis.||percent change||Full Range|Median
130909|NCT00546637|Secondary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS subjects with non-zero baseline and non-missing change from Baseline to Week 4 were included in the analysis.||number of episodes||Standard Error|Least Squares Mean
130910|NCT00546637|Primary|Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|The full analysis set (FAS) included all subjects who took at least one dose of assigned study drug and had at least one baseline or post-baseline efficacy assessment. Only FAS subjects with non-zero micturition-related urgency episodes at Baseline and non-missing change from Baseline to Week 12 (LOCF) were included in the analysis.||number of episodes||Standard Error|Least Squares Mean
130911|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130912|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130913|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130914|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130915|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).|Days 1 through 14 / Year 0|Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Year 0). Participants may be represented in more than 1 category.||percentage of participants|||Number
130916|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130917|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130918|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130919|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0, Days 1 through 14 / Year 1|Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130920|NCT00546572|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)|Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)|Days 1 through 14 / Year 0|Safety population is all participants who receive at least 1 dose of study vaccine. N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Vax 1). Participants may be represented in more than 1 category.||percentage of participants|||Number
130921|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
130922|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titers||95% Confidence Interval|Geometric Mean
130923|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)|Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype at both the postvaccination 1 and postvaccination 2 blood draws.||geometric mean titer||95% Confidence Interval|Geometric Mean
130924|NCT00546572|Secondary|Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
130925|NCT00546572|Primary|Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.|Baseline, 1 month after Vax 1 / Year 0|Evaluable Immunogenicity population. N=number of participants with a determinate antibody titer to the given serotype.||observed percentage of participants||95% Confidence Interval|Number
130926|NCT00546572|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after Vax 1 / Year 0|Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate OPA antibody titer to the given serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
130927|NCT00546481|Secondary|Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24|Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|Up to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.||Number of participants|||Number
130928|NCT00546481|Secondary|Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24|Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.||Beats per minute for heart rate||Standard Deviation|Mean
130929|NCT00546481|Secondary|Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24|Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.|From Baseline (Day 1) to Week 24|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. Only participants available at the time of assessment were included in the analysis.||millimeters of mercury||Standard Deviation|Mean
130930|NCT00546481|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 49|All participants who received at least one dose of the study medication and had a safety follow-up, whether withdrawn prematurely or not, included in the Safety Population. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.||Number of participants|||Number
130931|NCT00546481|Secondary|Number of Participants Who Received Red Blood Cells Transfusions up to Week 49|The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)|Up to Week 49|The Intent-to-Treat Population included all randomized participants.||Number of participants|||Number
130932|NCT00546481|Secondary|Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24|Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.|Up to Week 24|The Intent-to-Treat population included all randomized participants.||Days||95% Confidence Interval|Median
130933|NCT00546481|Secondary|Mean Change From Baseline in Hemoglobin Concentration at Week 24|Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value|From Baseline (Day 1) to Week 24|The Intent-to-Treat population included all randomized participants.||Grams per deciliter (g/dL)||Standard Deviation|Mean
130934|NCT00546481|Primary|Percentage of Participants Who Achieved Hemoglobin Response up to Week 24|Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented|Up to Week 24|The Intent-to-Treat population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
130935|NCT00546429|Secondary|Merle d'Aubigne and Postel||4 weeks, 3, 6 and 12 months||||||
130936|NCT00546429|Secondary|SF-12||4 weeks, 3, 6 and 12 months||||||
130937|NCT00546429|Secondary|Six Item Screener and Ambulatory Status||4 weeks, 3, 6 and 12 months||||||
130938|NCT00546429|Secondary|Medical Imaging||4 weeks, 3, 6 and 12 months||||||
130939|NCT00546429|Secondary|Lower Extremity Measure (LEM)||4 weeks, 3, 6 and 12 months||||||
130940|NCT00546429|Primary|Success in Terms of the Merle D'Aubigne Score|Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.|4 weeks, 3, 6 and 12 months|||Units on a scale||Standard Deviation|Mean
130941|NCT00546377|Primary|Maximum Tolerated Dose (MTD) of Mitoxantrone|The MTD is defined as the highest dose studied for which the incidence of DLT is less than 33%. In the phase I portion of the trial, cohorts of 3-6 pts will receive pentostatin, cyclophosphamide and rituximab along with one of three potential dose levels of mitoxantrone. The following dose escalation scheme will be followed: If none of the initial three pts in a cohort experience a dose-limiting toxicity (grade 4 infection, or grade ≥ 3 non-hematologic toxicity that persists for 7 days or more) then a new cohort of three pts will be treated at the next higher dose level. If one of the three pts in a cohort experiences DLT, then up to three additional pts will be treated at the same dose level. If two or more pts in a cohort experience DLT, then the maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. The previous dose level will be considered as the MTD.|2 years|||mg/m2|||Number
130942|NCT00546377|Primary|Overall Response|Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but at a minimum of prior to cycle four and following completion of all therapy. Patients who are removed from study early will have response status determined at time of removal from study. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.|3 years|||participants|||Number
130943|NCT00546364|Secondary|Median Number of Treatment Cycles|The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.|Day 1 to end of Cycle 18, maximum (54 weeks)|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Treatment cycles||Full Range|Median
130944|NCT00546364|Primary|Percentage of Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.||Percentage of patients|||Number
131054|NCT00545779|Primary|Percentage of Participants Who Reported Preference for Monthly Ibandronate|Percentage of participants who reported preference for monthly ibandronate were reported.|Visit 0 (<= Day -30)|All enrolled participants who completed the part A of the study.||percentage of participants|||Number
130945|NCT00546364|Secondary|Duration of Response|Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.|Baseline (date of randomization) to date CR or PR criteria first met|This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.|||||
130946|NCT00546364|Secondary|Time to Progression|Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.|Baseline to date progressive disease reported|This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.|||||
130947|NCT00546364|Secondary|Number of Participants With Abnormalities in Serum Chemistry Laboratory Results|ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Participants|||Number
130948|NCT00546364|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.|Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Participants|||Number
130949|NCT00546364|Secondary|Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.|Baseline to end of Cycle 1 (21 days), continuously|All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.||Participants|||Number
130950|NCT00546364|Secondary|Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.|Baseline to 6 weeks (end of Cycle 2)|All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.||Percentage of NTN Participants|||Number
130951|NCT00546364|Secondary|Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial|The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).|Baseline to 6 weeks (end of Cycle 2)|All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.||Percentage of TN Participants|||Number
130952|NCT00546364|Primary|Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.|Baseline to 6 weeks (end of Cycle 2)|All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.||Participants|||Number
130953|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.~Data was not available for 69 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130954|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.~Data was not available for 33 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130955|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Last Visit.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.~Data was not available for 69 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130956|NCT00546351|Secondary|Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Baseline.|The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.|Baseline|"Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.~Data was not available for 33 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130957|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.|0 = no interference with activity and 10 = worst possible interference with activity.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130958|NCT00546351|Secondary|Average Pain Interference With Activity (11-point Likert Scale) at Baseline.|0 = no interference with activity and 10 = worst possible interference with activity.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."||units on a scale||Standard Deviation|Mean
130959|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Last Visit|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130960|NCT00546351|Secondary|Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.|0 = no interference with sleep and 10 = worst possible interference with sleep.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."||units on a scale||Standard Deviation|Mean
130961|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity at Last Visit.|0 = not sensitive and 10 = most sensitive sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130962|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness at Final Visit.|0 = not itchy and 10 = most itchy sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130963|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain at Last Visit.|0 = no deep pain and 10 = most intense deep pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130964|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain at Last Visit.|0 = no surface pain and 10 = most intense surface pain imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130965|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness at Final Visit.|0 = not unpleasant and 10 = most unpleasant sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.~Data was not available for 428 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130966|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness at Last Visit.|0 = not dull and 10 = most dull sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130967|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold at Last Visit.|0 = not cold and 10 = the coldest sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130968|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat at Last Visit.|0 = not hot and 10 = the most hot sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130969|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness at Last Visit.|0 = not sharp and 10 = most sharp sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130970|NCT00546351|Secondary|Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity at Last Visit.|0 = no pain and 10 = most intense pain sensation imaginable.|Baseline Visit; Last Visit (approximately 2 years)|"Of the 621 subjects of the Safety Set (SS), 195 are included in this analysis.~Data was not available for 426 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130971|NCT00546351|Secondary|Patient’s Global Impression of Change (PGIC) at Last Visit.|"The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).~Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse)."|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 551 are included in this analysis.~Data was not available for 70 subjects at the time of this measurement."||percentage of participants|||Number
130972|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.|On VAS 0 mm = no pain and 100 mm = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 214 are included in this analysis.~Data was not available for 407 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130973|NCT00546351|Secondary|Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.|Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 213 are included in this analysis.~Data was not available for 408 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130974|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Last Visit (approximately 2 years)|"Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.~Data was not available for 2 subjects at the time of this measurement."||units on a scale||Standard Deviation|Mean
130975|NCT00546351|Secondary|Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.|On the Likert Scale, 0 = no pain and 10 = worst possible pain.|Baseline|"Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.~Data was not available for 1 subject at the time of this measurement."||units on a scale||Standard Deviation|Mean
130976|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|"A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:~Is fatal~Is life-threatening~Results in persistent or significant disability/incapacity~Requires inpatient hospitalization~Prolongs existing inpatient hospitalization~Is a congenital anomaly/birth defect~Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above"|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).||participants|||Number
130977|NCT00546351|Primary|Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From entry Visit 1 through end of treatment (approximately 6.5 years)|This analysis includes all subjects (all 621) in the Safety Set (SS).||participants|||Number
130978|NCT00546273|Primary|Number of Clinically Relevant Abnormalities in the Laboratory Tests According to the Doctors' Impression|haematological and biochemical laboratory tests|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156|All the participants of the study were analyzed for this specific outcome measure.||number of abnormalities|||Number
130979|NCT00546273|Primary|Occurrence, Intensity and Relationship to Vaccination of Local and Systemic Events||during the whole study||11/2008||||
130980|NCT00546273|Secondary|Evaluation of the Immunogenicity of the Different Doses of the Vaccine Tested|Immunological assays are performed at all timepoints to determine vaccine immunogenicity|at protocol defined timepoints: days 0, 7, 21, 28, 35, 56, 112 & 156||11/2008||||
130981|NCT00546273|Primary|VAS Pain Score (Visual Analogic Scale, That Ranges From 0 to 100) to Evaluate Each Volunteer Subjective Pain Intensity at the Inoculation Point||at protocol defined timepoints: days 0, 1, 3, 7, 21, 28, 29, 31, 35, 56||11/2008||||
130982|NCT00546260|Secondary|Percentage ST-segment Resolution Prior to PCI|The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI.|Before primary PCI|Per protocol.||Percentage of ST-segment Resolution||Inter-Quartile Range|Median
130983|NCT00546260|Secondary|Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI|This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter.|Time for contrast to reach a standardized distal coronary landmark in the culprit vessel|Per protocol||frames per minute||Inter-Quartile Range|Median
130984|NCT00546260|Primary|Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days|"TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit.~TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10–15%.~GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention.~GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention.~Stroke:New focal neurologic deficit that does not resolve within 24 hours."|30 days|"All subjects receiving some component of study drug (the as-treated population)"||Participants|||Number
130985|NCT00546156|Secondary|Decrease in Interstitial Fluid Pressure.|To determine if bevacizumab monotherapy results in a decrease in interstitial fluid pressure|3 years|This represents the number of patients with paired IFP measurements from day 0 and day 14||mm Hg||Inter-Quartile Range|Median
130986|NCT00546156|Primary|Pathologic Complete Response Rate After Preoperative Therapy in This Patient Population.|Pathological Complete response is defined as complete disappearance of invasive tumor in the breast at the time of surgery|3 Years|Participants who met all study eligibility criteria and signed informed consent.||percentage of participants|||Number
130987|NCT00546117|Primary|Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar||2 months|||participants|||Number
130988|NCT00546117|Secondary|Reflux Symptom Questionnaires||1 and 2 months||||||
130994|NCT00546104|Secondary|Correlate SRC Dysregulation Results With Response to Dasatinib Therapy|Since all patients progressed there is no comparison to between responders and non-responders.|16 weeks|20 patients with baseline and 4 week Src measures. 11 patients came off due to screen failure, toxicity or progression before 4 week biopsy.||percentage change in p-SRC||95% Confidence Interval|Mean
130995|NCT00546104|Secondary|Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response)|For the 20 patients with evaluable biopsies at baseline and week 4, the median relative change from baseline in tissue biomarker levels of phospho-Src (p-Src)|4 weeks|Twenty patients with evaluable biopsies at baseline and 4 week follow-up||percentage of change in p-SRC||Inter-Quartile Range|Median
130996|NCT00546104|Secondary|To Measure Response to Protocol Therapy Per RECIST Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as a reference the smallest sum longest diameter recorded since treatment started, or the appearance of one or more new lesions.~RECIST 1.0 Overall response:~Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD)~CR= CR+CR and No new lesions PR= CR+SD; PR+SD and no new lesions SD= SD+SD and no new lesions PD= PD+any new lesions"|16 weeks|Proportion with Best Response of Stable Disease||percentage of participants|||Number
130997|NCT00546104|Primary|Estimation of the Proportion of Progression-free Patients at 16 Wks.|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as appropriate.~Proportion progression-free at 16 weeks.From first day of study related treatment with Dasatinib until the date of first documented progression or date of death from any cause, whichever came first."|16 weeks|31 patients on this trial, 1 patient was found to have disease progression at 16-weeks, 16 patients had disease progression prior to 16 weeks, 8 patients were taken off-treatment due to toxicity, and 6 patients voluntarily withdrew from treatment. These latter two groups of patients were censored in the analysis of Progression Free Survival.||percentage of participants||95% Confidence Interval|Number
130998|NCT00546078|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 18|||subjects|||Number
130999|NCT00546078|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 18|||subjects|||Number
131000|NCT00546078|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|From Day 0 up to Month 18|Analysis was performed on those subjects reporting pregnancy during the study period.||Outcome|||Number
131001|NCT00546078|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed."|Within 30 days of vaccination|||subjects|||Number
131002|NCT00546078|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|At Day 7 and at Month 1 (Day 30)|Analysis was performed on the ATP cohort for immunogenicity.||titer||95% Confidence Interval|Geometric Mean
131003|NCT00546078|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.~Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days of vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.||subjects|||Number
131004|NCT00546078|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed."|Within 7 days after vaccination|Analysis was performed on those subjects from the Total Vaccinated Cohort with available results.||subjects|||Number
131005|NCT00546078|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).~Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.||EL.U/mL||95% Confidence Interval|Geometric Mean
131006|NCT00546078|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples|"Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.~Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter."|Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the subset of subjects from the ATP cohort for immunogenicity for whom cervical secretion samples were collected.||subjects|||Number
131007|NCT00546078|Secondary|Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.~A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.||subjects|||Number
131008|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.||subjects|||Number
131009|NCT00546078|Secondary|Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types|"CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells."|Day 0, Month 1 [Day 30], Month 7 and Month 18|Analyses were performed on a subset (from pre-defined study sites) of subjects from the ATP cohort for immunogenicity.||subjects|||Number
131010|NCT00546078|Secondary|Anti-HPV-31 and Anti-HPV-45 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Day 7, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity||titer||95% Confidence Interval|Geometric Mean
131011|NCT00546078|Secondary|Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL||Day 0, Month 1 (Day 30), Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
131012|NCT00546078|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as GMTs calculated on all subjects.|At Month 7 and Month 18|Analysis was performed on the APT cohort for immunogenicity||titer||95% Confidence Interval|Geometric Mean
131013|NCT00546078|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7 and Month 18|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
131014|NCT00546078|Primary|Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values|Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Day 7 and Month 1 (Day 30)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
131015|NCT00546052|Other Pre-specified|Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments|Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks – C Reactive Protein Baseline.|52 Weeks - Baseline|Per Protocol||mg/L||Standard Deviation|Mean
131016|NCT00546052|Other Pre-specified|Absolute Change in Uric Acid Between Baseline and 52 Week Assessments|Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks – Uric Acid Baseline.|52 Weeks - Baseline|Per Protocol||mmol/L||Standard Deviation|Mean
131017|NCT00546052|Other Pre-specified|Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments|Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks – Total Cholesterol Baseline) / (Total Cholesterol Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Mean
131018|NCT00546052|Other Pre-specified|Percent Change in Triglycerides Between Baseline and 52 Week Assessments|Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks – Triglycerides Baseline) / (Triglycerides Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Median
131019|NCT00546052|Other Pre-specified|Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks – HDL-C 52 Baseline) / (HDL-C Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Mean
131020|NCT00546052|Other Pre-specified|Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments|Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks – LDL-C Baseline) / (LDL-C Baseline)].|52 Weeks - Baseline|Per Protocol||Percent Change||Standard Deviation|Mean
131021|NCT00546052|Other Pre-specified|Change in Body Mass Index Between Baseline and 52 Week Assessments|Absolute change in Body Mass Index Baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol||Kg/m2||Standard Deviation|Mean
131022|NCT00546052|Other Pre-specified|Change in Waist Circumference Between Baseline and 52 Week Assessments|Absolute change in Waist Circumference between baseline and 52 week assessments|52 Weeks - Baseline|Per Protocol||cm||Standard Deviation|Mean
131023|NCT00546052|Secondary|Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol||mm Hg||Standard Deviation|Mean
131024|NCT00546052|Secondary|Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments|Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol||mm Hg||Standard Deviation|Mean
131025|NCT00546052|Secondary|Target Blood Pressure|Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks|52 Weeks|ITT and Per Protocol||Participants|||Number
131026|NCT00546052|Primary|Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments|Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.|52 Weeks - Baseline|Per Protocol||mmol/L||Standard Deviation|Mean
131027|NCT00546052|Primary|Change in Hemoglobin A1c Between 52 Weeks and Baseline|Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.|52 Weeks - Baseline|Per Protocol||Percent||Standard Deviation|Median
131028|NCT00546000|Secondary|Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity|The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.|Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29|||participants|||Number
131029|NCT00546000|Primary|Post Treatment Serum Cortisol Values Will be Compared.|The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.|Up to 29 days of treatment|||participants|||Number
131030|NCT00545974|Primary|Clinical Global Impression of Change (CGIC)|The scale is rated on a 7-point scale, using a range of responses from 1 (very much improved) through 7 (very much worse). The clinician compares the participant's current condition to the condition at admission to the project.|26 Weeks|||units on a scale||95% Confidence Interval|Mean
131031|NCT00545974|Secondary|CDR-FTD, MMSE, FAQ, TFLS, EXIT25, UCSF FTD-Neuropsychological Test Battery: CVLT, Verbal Fluency, Modified BNT, Backward Digit Span, Digit Symbol Test, Modified Trails B, Modified Unified Parkinson's Disease Rating Scale, Antipsychotic Therapy||26 Weeks||||||
131032|NCT00545974|Primary|Change in Neuropsychiatric Inventory (NPI)|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions indicate that the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, 26 weeks|||units on a scale||95% Confidence Interval|Mean
131033|NCT00545948|Secondary|Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.|2 years|There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented.|||||
131034|NCT00545948|Secondary|Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer|Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire.|Baseline|Twenty-six questionnaires were returned. There was insufficient numbers to provide for substantive analysis.|||||
131035|NCT00545948|Secondary|2-Year Overall Survival in Patients Treated for NSCLC|Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||percentage of treated patients||95% Confidence Interval|Number
131036|NCT00545948|Secondary|Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy|The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies.|4 years|||Percentage of participants|||Number
131037|NCT00545948|Primary|2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC|Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive.|2 years|Due to the irreproducible nature of the genomic signatures of chemotherapeutic sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||percentage of treated patients||95% Confidence Interval|Number
131038|NCT00545844|Other Pre-specified|Patient Global Allergic Rhinitis Symptoms Assessment|At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
131039|NCT00545844|Other Pre-specified|Physician Global Satisfaction|At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient’s asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
131040|NCT00545844|Other Pre-specified|Patient Global Satisfaction|At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
131041|NCT00545844|Secondary|Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.|8 weeks (from Week 0 to Week 8)|There were 313 patients who qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit; of these, 300 patients completed the ACQ at week 8.||Units on a Scale||Standard Deviation|Mean
131042|NCT00545844|Secondary|The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score|Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score – Week 0 score|8 weeks (from Week 0 to Week 8)|Based on ITT population; there were 286 patients with available data regarding the mean change in MiniRQLQ at week 8.||Units on a Scale||Standard Deviation|Mean
131043|NCT00545844|Primary|Asthma Control|Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered “yes” to at least 2 of the 8 asthma control parameters.|8 weeks (from Week 0 to Week 8)|319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.||Participants|||Number
131044|NCT00545792|Secondary|Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.|1-year|20 patients received and completed treatment.||participants|||Number
131045|NCT00545792|Primary|Toxicity Rates of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy|Toxicity was the cumulative number of events, all grades and categories, related to side effects from avastin and radiation including, but not limited to, bowel, bladder, skin, gynecologic and other morbidity.|1-year|20 patients received and completed treatment.||Events|||Number
131046|NCT00545779|Secondary|Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1–6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11–16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0–100-point scale, in which higher scores indicate greater satisfaction.|Baseline, Month 6|The ITT population included all participants who received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
131047|NCT00545779|Secondary|Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B||Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.|||||
131048|NCT00545779|Secondary|Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B||Baseline to Month 6|Analysis was not performed because the data were difficult or impossible to derive from the database.|||||
131049|NCT00545779|Secondary|Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
131050|NCT00545779|Secondary|Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B||Up to Month 6|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
131051|NCT00545779|Secondary|Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B|"Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication"|Month 6|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
131052|NCT00545779|Secondary|Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ||Visit 0 (<= Day -30)|The ITT population included all participants who received at least one dose of study medication.||percentage of participants|||Number
131053|NCT00545779|Primary|Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group|Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.|Month 6|The intent-to treat (ITT) population included all participants who received at least one dose of study medication. Number of participant analyzed are with or without previous history of Fr.||percentage of participants|||Number
131055|NCT00545779|Primary|Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer ‘Yes’ to Any of the Questions in the Candidate Identification Questionnaire (CIQ)|"The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.~In the CIQ participants were asked to answer either ‘yes’ or ‘no’ to the following 3 questions:~I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.~More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.~Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication."|Visit 0 (less than or equal to [<=] Day -30)|All enrolled participants who completed the part A of the study.||percentage of participants|||Number
131056|NCT00545766|Secondary|Time to PSA Progression and Overall Survival Will be Summarized Via Kaplan-Meier-type Plots, and by Medians With Corresponding 95% Confidence Interval (CI).||18 months||||||
131057|NCT00545766|Primary|Protein-specific Antigen (PSA) Response Rate|Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.|18 months|||percentage of patients||95% Confidence Interval|Number
131058|NCT00545753|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|558 subjects were randomized to treatment and 540 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. At Day 7 if subject presented with live lice they were provided a second treatment to be used within 24 hours. Thus subjects used 1 or 2 treatments.||Incidents|||Number
131059|NCT00545753|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.||participants|||Number
131060|NCT00545740|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||Up to 104 weeks|Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
131061|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
131062|NCT00545740|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
131063|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
131064|NCT00545740|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
131065|NCT00545740|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|Up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT scans|||Number
131066|NCT00545740|Secondary|Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|Up to 104 weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
131067|NCT00545688|Secondary|Progression Free and Disease Free Survival|DFS was defined as the time from the first date of no disease (date of surgery) to the first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. PFS was defined as the time from the date of randomization to the first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. DFS and PFS were determined using Kaplan-Meier estimates.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.||percentage of participants||80% Confidence Interval|Median
131068|NCT00545688|Secondary|Percentage of Participants Who Were Progression Free and Disease Free|Disease-free survival (DFS) was defined as the time from first date of no disease to first documentation of PD or death. Participants without progression after surgery were considered Disease Free. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from the study without documented progression and for whom evaluations were made, were censored at date of last assessment when participant was known to be disease-free. Progression-free survival (PFS) was defined as time from date of randomization to first documentation of PD or death. Any evidence of contralateral disease in-situ was not considered as PD. Participants who were withdrawn from study without documented progression and for whom evaluations were made, were censored at date of last assessment when the participant was known to be free from progressive disease. Participants without post baseline assessments but known to be alive were censored at the time of randomization.|Randomization up to a maximum of 329 weeks|ITT Population; Analysis was performed according to initial randomization.||percentage of participants|||Number
131069|NCT00545688|Secondary|Percentage of Participants Achieving Breast Conserving Surgery For Whom Mastectomy Was Planned|Breast Conserving Surgery (BCS) was defined as quadrantectomy, lumpectomy, no surgery, sentinel node biopsy, axillary surgical resection or other method of avoiding mastectomy.|Surgery (Within 2 weeks after Cycle 4) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants||95% Confidence Interval|Number
131070|NCT00545688|Secondary|Percentage of Participants With Progressive Disease During Neo-Adjuvant Treatment Period|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: PD: if lesion is at least a 20 % increased from measurements at baseline. Percentage of participants along with 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method were reported. Missing investigator assessments were considered as no progressive disease.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization.||percentage of participants||95% Confidence Interval|Number
131071|NCT00545688|Secondary|Time to Clinical Response During Neo-Adjuvant Treatment Period|Time to clinical response was defined as the time from the date of first dose received to the date of assessment of clinical response. Time to Clinical response was determined by Kaplan-Meier estimates. Tumor assessments were made based on the RECIST criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||months||80% Confidence Interval|Median
131072|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Primary breast tumor clinical response is based on primary breast tumor assessment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.||percentage of participants||95% Confidence Interval|Number
131073|NCT00545688|Secondary|Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography|Clinical response was determined based on tumor measurements by sponsor in combination with tumor response assessment by investigator. Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes). Clinical Responders are participants who have achieved CR or PR during the Neo-adjuvant treatment. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome and n = number participants analyzed in the specified category.||percentage of participants||95% Confidence Interval|Number
131099|NCT00545441|Primary|Healing Success|Healing was defined as “closure of external opening with absence of abscess, drainage and pain.”|12 months|Patients that were lost to follow-up, withdrew, or not treated were not included in the analysis. In the Surgisis arm, there were 9 patients lost to follow-up, 1 patient withdrew, and 1 patient not treated; in the Flap arm, there were 5 patients lost to follow-up, 1 patient withdrew, and 3 patients not treated.||participants|||Number
131074|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
131075|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination|Tumor assessments were made based on the RECIST criteria - version 1.0 The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
131076|NCT00545688|Secondary|Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography|Tumor assessments were made based on the RECIST criteria - version 1.0 The overall response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Overall response is derived based on the sum total of breast tumors and all nodes examined.|Baseline up to Cycle 4 (assessed at Baseline, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
131077|NCT00545688|Primary|Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.||percentage of participants|||Number
131078|NCT00545688|Primary|Percentage of Participants Achieving pCR by Lymph Node Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Lymph node status was defined as either negative lymph node at surgery or positive lymph node at surgery. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.||percentage of participants|||Number
131079|NCT00545688|Primary|Percentage of Participants Achieving pCR by Hormone Receptor Status|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. n = number of participants included in the specified hormone receptor status.||percentage of participants||95% Confidence Interval|Number
131080|NCT00545688|Primary|Percentage of Participants Achieving pCR by Breast Cancer Type|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders.|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization. Number (n) equal (=) number of participants included in the specified type of breast cancer.||percentage of participants||95% Confidence Interval|Number
131100|NCT00545402|Secondary|Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review|The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population; only participants with evaluable biopsies were included in the analysis.||percentage of participants|||Number
131081|NCT00545688|Secondary|Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography|Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of ‘0’ is noted at a given cycle as compared to baseline measurement which is greater than (>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.|Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months|ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
131082|NCT00545688|Primary|Percentage of Participants Achieving Pathological Complete Response (pCR)|pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders|Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4)|ITT Population; Analysis was performed according to initial randomization.||percentage of participants||95% Confidence Interval|Number
131083|NCT00545662|Primary|Functional and Cognitive Outcome|The primary outcome of this study was analyzed using a global statistic of the Network Core Battery. There were 9 scales: California Verbal Learning Test II (CVLT-II); Controlled Oral Word Association Test (COWAT); Digit Span (DS); Glasgow Outcome Scale Extended (GOSE); Processing Speed Index (PSI); Stroop Test 1 and 2 (ST1&2); and Trail Making Test part A and B (TMT parts A and B). Each scale was assigned cut-off for good outcome: GOSE>7, CVLT>36, PSI>85, TMT part A <42, TMT part B<138.1, DS>7.15, ST1<60.29, ST2<151.47, COWAT>32.5. Logistic regression was used to estimate the global OR.|90 days|The analysis included both the patients with complete outcome data and those with at least one measure. Patients who died were also included in the analysis.||percentage of participants|||Number
131084|NCT00545623|Primary|Changes in GI Symptom Per Intervention Session|We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here.|8 weeks|An intent-to-treat approach was used for analysis. That is all patients who had at least one data points were included in the analysis.||units on a scale||Standard Error|Mean
131085|NCT00545584|Secondary|Fasting Plasma Glucose (FPG) Measurement|Generally FPG values of ~5.0–7.2 mmol/L would be considered goal (American Diabetes Association).|Baseline and Week 24|FAS population. Furthermore, only 350, 252, and 350 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Baseline; and 303, 224, and 310 subjects had FPG evaluations in the Diet advice, Diet & physical activity advice, and Standard groups, respectively, at Week 24.||mmol/L glucose||Standard Deviation|Mean
131086|NCT00545584|Primary|Hemoglobin A1c Measurement|Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.|Baseline and Week 24|The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin. In the Standard of Care group, only 360 subjects had HbA1c Baseline evaluations.||percent HbA1c||Standard Deviation|Mean
131087|NCT00545571|Secondary|Percentage of Participants Who Received Blood Transfusions During the DTP and LTSP|The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and LTSP (Weeks 18 to 52) was reported.|From Week 0 (every week until Week 2, every 2 weeks until Week 48) through the final visit at Week 52|ITT Population.||percentage of participants|||Number
131088|NCT00545571|Secondary|Mean Dose of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and LTSP and expressed in mcg.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population; only those participants (n = number) who provided evaluable data were included in the analysis.||mcg||Standard Deviation|Mean
131089|NCT00545571|Secondary|Mean Number of Months a Participant Required Dose Adjustment of Mircera/CERA During the DTP and LTSP|Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the LTSP (Weeks 18 to 52) on the basis of Hb levels or other modification criteria. The mean number of months required for dose adjustment for any reason was calculated and averaged among all participants during the DTP and LTSP.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|Safety Population: All participants who received at least one dose of trial medication and at least one safety follow-up assessment, whether prematurely withdrawn or not; only those participants (n = number) who provided evaluable data were included in the analysis.||months||Standard Deviation|Mean
131101|NCT00545402|Secondary|Overall Survival at Month 12|The median time, in months, between randomization and OS event. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population||months||Full Range|Median
131102|NCT00545402|Secondary|Overall Survival (OS) at Month 12 - Percentage of Participants With an Event|OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12|ITT population||percentage of participants|||Number
131790|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy|Percent change in specific tumor marker (Cancer Antigen 19-9, Ca 19-9) levels in response to neoadjuvant therapy|Baseline and 2 years|||percent change||Full Range|Median
131090|NCT00545571|Secondary|Mean Excursions Above or Below Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Deviation from the country-specific target range was calculated as [Hb value minus country-specific upper bound] for deviations above the target range and [Hb value minus country-specific lower bound] for deviations below the target range. Deviations were averaged among all Hb values from all participants and expressed in g/dL, reported separately as mean deviation above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and mean deviation below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.||g/dL||Standard Deviation|Mean
131091|NCT00545571|Secondary|Mean Time Spent Above or Below the Target Range for Hb During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent outside the country-specific target range was defined as time from each off-target Hb to time of next on-target Hb, as collected during the LTSP. Time spent outside the target range was averaged among all participants and expressed in days, reported separately as time spent above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and time spent below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP or at the last DTP visit were included in the analysis.||days||Standard Deviation|Mean
131092|NCT00545571|Secondary|Percentage of Hb Values Above or Below the Target Range During the LTSP|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of all Hb values outside of the country-specific target range was determined and reported separately as Hb values above the upper bound (13.0 g/dL in Switzerland and 12.0 g/dL in Austria) and Hb values below the lower bound (11.0 g/dL in Switzerland and 10.0 g/dL in Austria).|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only those participants (n = number) who entered the LTSP and had at least one Hb excursion during the LTSP were included in the analysis.||percentage of Hb values|||Number
131093|NCT00545571|Secondary|Percentage of Participants Who Maintained Average Hb Within Target Range Throughout the EEP|During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.||percentage of participants||95% Confidence Interval|Number
131094|NCT00545571|Secondary|Mean Time Spent in the Target Range for Hb During the Long-Term Safety Period (LTSP)|During the LTSP (Weeks 18 to 52), participants provided a total of 16 pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. Time spent in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.|Pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48|ITT Population; only participants who entered the LTSP were included in the analysis.||days||Standard Deviation|Mean
131095|NCT00545571|Secondary|Mean Change in Time-Adjusted Hb From Baseline to EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|ITT Population.||g/dL||Standard Deviation|Mean
131096|NCT00545571|Primary|Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP)|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to 0). During the EEP (Weeks 18 to 24), participants provided a total of four pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Sampling was also performed prior to each dialysis session. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the country-specific target range (11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria) and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24|Per Protocol (PP) Population: All participants from the Intent-to-Treat (ITT) Population who fulfill select criteria per study protocol.||percentage of participants||95% Confidence Interval|Number
131097|NCT00545506|Primary|Tissue Oxygen Tension in the Sternal Wound|Tissue oxygen tension in the wound Tissue oxygen tension will be measured with a polarographic electrode system (Licox CMP, GMS Germany), the oxygen electrode will be calibrated with room air (154 mmHg) and then positioned within the silastic tonometer that will be inserted 2 3 cm lateral to the surgical incision.|8 hours|||mmHG|||Number
131098|NCT00545506|Primary|Tissue Oxygenation Levels||2 years||11/2009||||
131103|NCT00545402|Secondary|Graft Survival|The median time, in months, between randomization and graft loss event. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population||months||Full Range|Median
131104|NCT00545402|Secondary|Percentage of Participants With Graft Loss|Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.|ITT population||percentage of participants|||Number
131105|NCT00545402|Primary|Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant|Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.|Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment|ITT population||percentage of participants|||Number
131106|NCT00545363|Secondary|Percent Change From Baseline in CTX Based on Adherence to Ibandronate|Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6). The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations. Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of ‘drug dispensed’ and ‘drug returned’ on CRF and participant’s self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Baseline, Month 6|"ITT population. Number of participants analyzed = participants evaluable for this outcome and n represents number of participants analyzed for the specified category."||percent change||95% Confidence Interval|Least Squares Mean
131107|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score|OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction. OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study. Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction. The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
131108|NCT00545363|Secondary|Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores|The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16). Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale. Higher scores indicated greater treatment satisfaction. A score of 80 or more was considered as high score.|At Month 6|ITT population. Number of participants analyzed = participants evaluable for this outcome.||percentage of participants|||Number
131109|NCT00545363|Primary|Percentage of Participants With Adherence to Treatment|Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month. Participant adherence was assessed by maintaining records of ‘drug dispensed’ and ‘drug returned’ on case report form (CRF) and participant’s self-report on Visit 2 (Month 3) and final study visit (Month 6). A drug dispensing log was maintained by the investigator. Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.|Up to 6 months|Intent to treat (ITT) population included all randomized participants. Number of participants analyzed=number of participants evaluable for this outcome.||percentage of participants|||Number
131110|NCT00545298|Primary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|All reported adverse events, related or unrelated to the study drug.|up to 24 weeks|All enrolled subjects, 4 in total||number of events|||Number
131111|NCT00545298|Primary|Wound Healing|% Re-epithelialization|Week 20|Per protocol. Only one subject met the 20 week time point. All other subjects withdrew early from the study and did not reach the Week 20 time point||% re-epithelialization|||Number
131112|NCT00545272|Secondary|Number of Participants Using Rescue Medication|Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.|Over 14 days|Intent to treat||participants|||Number
131143|NCT00545168|Secondary|Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.|To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|480 subjects were randomized to treatment and 469 subjects used the study drug and returned for at least one post-baseline evaluation. At Day 0 the study drug was to be used within 24 hours. Thus subjects used 1 or 2 treatments.||Incidents|||Number
131113|NCT00545272|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow|The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.|Baseline (recorded during the screening period) and Days 1-14 (treatment period)|"Intent to treat population. The analysis only includes patients with non-missing data, indicated by N."||liters/minute||Standard Deviation|Mean
131114|NCT00545272|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.|Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose|"The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by N."||minutes||Standard Deviation|Mean
131115|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1|FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
131116|NCT00545272|Secondary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Day 1 Baseline (prior to first dose) and 24 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
131117|NCT00545272|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose|FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.|Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only.||liters||Standard Error|Least Squares Mean
131118|NCT00545272|Primary|The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.|Baseline (prior to first dose) and Day 15 (24 hours after last dose)|The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.||liters||Standard Error|Least Squares Mean
131119|NCT00545233|Secondary|Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed|The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression.|Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Safety population who received at least one dose of study drug and who had data available at the given time point for analysis.||Percentage of Participants|||Number
131120|NCT00545233|Secondary|Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed|"Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
131121|NCT00545233|Secondary|Change From Baseline in Leptin Levels at Each Time Point Assessed|"Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||ng/mL||Standard Error|Mean
131122|NCT00545233|Secondary|Change From Baseline in Adiponectin Levels at Each Time Point Assessed|"Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||μg/mL||Standard Error|Mean
131123|NCT00545233|Secondary|Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed|"Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||pg/mL||Standard Error|Mean
131124|NCT00545233|Secondary|Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed|"Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||pg/mL||Standard Error|Mean
131125|NCT00545233|Secondary|Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
131126|NCT00545233|Secondary|Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
131127|NCT00545233|Secondary|Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed|"Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
131128|NCT00545233|Secondary|Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed|"Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control.~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
131129|NCT00545233|Secondary|Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed|"Insulin resistance (IR) is calculated using the following formula:~HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405.~Baseline for with pioglitazone arm occurred prior to the start of 16 week run-in period and for without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated.~A normal patient can have a HOMA score up to 3. A patient with a score of >3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||HOMA Score||Standard Error|Mean
131130|NCT00545233|Secondary|Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed|"Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||Percent||Standard Error|Mean
131131|NCT00545233|Secondary|Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.|"Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||pmol/L||Standard Error|Mean
131189|NCT00544869|Primary|Body Weight|The change of body weight from baseline at final observation|Baseline, Day 14 or at the time of final drug administration|||Kg||Standard Deviation|Mean
131132|NCT00545233|Secondary|Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed|"Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).~Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated."|Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72|Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.||mmol/L||Standard Error|Mean
131133|NCT00545233|Secondary|Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only|Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated.|Randomization (Week-16),Weeks -12, -8, -4 and 0|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||IU/mL||Standard Error|Mean
131134|NCT00545233|Secondary|Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period|Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
131135|NCT00545233|Secondary|Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks|Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA.|Up to 48 Weeks|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
131136|NCT00545233|Secondary|Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)|Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy.|Week 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
131137|NCT00545233|Secondary|Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72|Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated.|Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population included all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.||Percentage of Participants|||Number
131138|NCT00545233|Secondary|Percentage of Participants Achieving Virologic Response|Virologic response was defined as undetectable HCV RNA < 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders.|Weeks 4, 12, 24, 48, 60, 72|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment.||Percentage of Participants|||Number
131139|NCT00545233|Secondary|Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.||IU/mL||Standard Error|Mean
131140|NCT00545233|Primary|Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy|Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.|Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment|Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.||IU/mL||Standard Error|Mean
131141|NCT00545181|Primary|Recurrent Bacterial Vaginosis|Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.|3 months|||Participants|||Number
131142|NCT00545168|Primary|Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice|The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).|Assessment were made 14 days following the final product treatment|Primary efficacy analysis was conducted using the Intent to Treat data obtained from primary subjects (i.e., youngest enrolled members of each household who had at least three live lice at the time of entry into the study). Subjects who were lice free 14 days post-treatment were considered successes and all other subjects were considered failures.||participants|||Number
131144|NCT00545155|Primary|Concurrent Criterion Validity of PHQ-2|"This is the PHQ-2, a test for depression (scoring=yes or no) as compared to the PHQ-9, a test for depression (scoring=yes or no), looking at the presence of depression.~This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours|||kappa||95% Confidence Interval|Number
131145|NCT00545155|Primary|Test-Retest Reliability Testing of PHQ-2 Screening|The test for depression, using the PHQ-2, with scoring yes or no.|2 hours|||kappa||95% Confidence Interval|Number
131146|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
131147|NCT00545155|Primary|Proportion of Subjects Depressed in the ED|Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.|Within 2 hours of EMS testing.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
131148|NCT00545155|Primary|Proportion of Subjects Depressed in EMS.|Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
131149|NCT00545155|Primary|Concurrent Criterion Validity of Six Item Screener Screening|"This is the Six Item Screener test for cognitive impairment (scoring=yes or no), as compared to performing the Mini-Cog for cognitive impairment (scoring=yes or no) on patients immediately afterwards.~This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice)."|2 hours|||kappa||95% Confidence Interval|Number
131150|NCT00545155|Primary|Test-Retest Reliability of Six Item Screener Screening|The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.|2 hours|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||kappa||95% Confidence Interval|Number
131151|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the ED|Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.|Within 2 hours of testing by EMS|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
131152|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.|Within 2 hours of testing by EMS.|All of the subjects enrolled who completed all aspects of the testing.||percentage of subjects|||Number
131153|NCT00545155|Primary|Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)|Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.|Upon testing by EMS.|All of the subjects enrolled who completed follow up and completed all aspects of the testing.||percentage of subjects|||Number
131154|NCT00545103|Secondary|Percent of Subjects Requiring Surgery for Diverticulitis||up to 104 Weeks|Full Analysis Set||percentage of subjects|||Number
131155|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
131156|NCT00545103|Secondary|Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
131157|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative|A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
131158|NCT00545103|Secondary|Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive|A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.|up to 104 Weeks|Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.||Number of CT Scans|||Number
131159|NCT00545103|Secondary|Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis|CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.|up to 104 weeks|Full Analysis Set||percentage of subjects|||Number
131160|NCT00545103|Primary|Percent of Subjects Without Recurrence of Diverticulitis|Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.|up to 104 Weeks|Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.||percentage of subjects|||Number
132468|NCT00534105|Secondary|Triglyceride Values|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum|||mg/dl||Inter-Quartile Range|Mean
131161|NCT00545064|Other Pre-specified|Change in Intra-ocular Pressure (IOP) for Worse Eye From Baseline to Week 4 and From Baseline to Week 8, in Patients Receiving Preservative-free Dorzolamide-timolol|IOP measurements using Goldmann applanation tonometry, performed by a masked physician two hours after patient was administered study medication. Change is computed as week 4 (or week 8) value minus baseline value.|Baseline to Week 4 and from Baseline to Week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on IOP were available for 164 and 166 patients at week 4 and 8 respectively||mm Hg||Standard Deviation|Mean
131162|NCT00545064|Other Pre-specified|Physician’s Global Satisfaction|At week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient’s treatment, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).||Participants|||Number
131163|NCT00545064|Other Pre-specified|Patient’s Global Satisfaction|At week 8, patients were asked to complete a single question describing how satisfied they were regarding with their medication, on a 5-level scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, very dissatisfied.|Week 8|178 - number of patients that signed the consent form and received at least one dose of study medication. The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristics were available).||Participants|||Number
131164|NCT00545064|Primary|Change in Glaucoma Symptom Scale (GSS)-SYMP-6 Score|GSS-SYMP-6 measures 6 non-visual adverse symptoms related to glaucoma medications, with 10 5-point Likert scale questions. Score ranges between 0 and 100, lower scores indicating higher symptoms severity. Change equals post-baseline value minus baseline.|Baseline to week 8|176 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. Observations on GSS-SYMP-6 were available for 114 and 111 patients at week 4 and 8 respectively||Units on a Scale||Standard Deviation|Mean
131165|NCT00545051|Secondary|Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months|Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.|Month 6|ITT population||percentage of participants|||Number
131166|NCT00545051|Secondary|Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.|Baseline and Months 1, 6 and 12|ITT population; n=number of participants analyzed at the specified visit for the given parameter.||percent change in bone turnover markers||Standard Deviation|Mean
131167|NCT00545051|Secondary|Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12|Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.|Baseline and Months 6 and 12|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.||percent change in BMD||Standard Deviation|Mean
131168|NCT00545051|Secondary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6|Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.|Baseline and Month 6|ITT Population||percent change in BMD||Standard Deviation|Mean
131169|NCT00545051|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.|Baseline and Month 12|Intent-to-treat (ITT) population||percent change in BMD||Standard Deviation|Mean
131170|NCT00545025|Secondary|Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Fold increase||95% Confidence Interval|Geometric Mean
131171|NCT00545025|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Subjects|||Number
131172|NCT00545025|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).|At Day 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Subjects|||Number
131173|NCT00545025|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.||Titer||95% Confidence Interval|Geometric Mean
131174|NCT00545025|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-30)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
131175|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 30-day (Days 0-29) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
131176|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During a 7-day (Days 0-6) follow-up after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
131177|NCT00545025|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.|During a 7-day (Days 0-6) follow-up period after re-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
131178|NCT00544908|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After every two cycles, up to 5 years|||percentage of participants|||Number
131179|NCT00544908|Primary|Progression-free Survival (PFS) Rate at 4 Months|Progressive disease - appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).|Four months.|||percentage of participants|||Number
131180|NCT00544882|Secondary|Percentage of Participants With Bleeding During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||percentage of participants|||Number
131181|NCT00544882|Secondary|Number of Days of Bleeding During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||days||Standard Deviation|Mean
131182|NCT00544882|Secondary|Percentage of Participants With Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||percentage of participants|||Number
131183|NCT00544882|Secondary|Number of Days of Bleeding or Spotting During Unscheduled and Scheduled Study Periods|The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries.|Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21|Intent-to-treat||days||Standard Deviation|Mean
131184|NCT00544882|Secondary|Change From Cycle 2 Days 1 - 20 to Cycle 2 Days 21 - 28 in Maximum Follicle Size|The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound.|Cycle 2, Days 1-20 and Cycle 2, Days 21-28|Intent-to-treat population with available data.||mm||Standard Deviation|Mean
131185|NCT00544882|Primary|Serum Inhibin-B Levels by Cycle Day|Levels of inhibin-B were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).||pg/mL||Full Range|Median
131186|NCT00544882|Primary|Serum Follicle Stimulating Hormone (FSH) Levels by Cycle Day|Levels of follicle stimulating hormone were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).||mIU/mL||Full Range|Median
131187|NCT00544882|Secondary|Percentage of Follicles Greater Than 5 mm in Diameter|Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point).|Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.|Intent-to-treat||percentage of follicles|||Number
131188|NCT00544882|Primary|Serum Estradiol Levels by Cycle Day|Levels of estradiol were measured throughout the study from blood samples.|Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.|Intent-to-treat population with available data at each time point (as indicated by n).||pg/mL||Full Range|Median
131190|NCT00544817|Secondary|Objective Response|"The number of patients with complete or partial responses measured from the time of initial response to documented tumor progression. Radiologic response was defined using the Macdonald criteria.~The Macdonald criteria divides response into 4 types of response based on imaging (MRI) and clinical features, as follows: 1) complete response (CR); 2) partial response (PR); 3) stable disease (SD); and 4) progression (PD).~Criteria:~CR: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions. No corticosteroids, clinically stable or improved.~PR: >=50% decrease of all measurable enhancing lesions, sustained for at least 4 weeks, no new lesions. Stable or reduced corticosteroids, clinically stable or improved.~SD: does not qualify for complete response, partial response or progression. Clinically stable.~PD: >= 25% increase in enhancing lesions, any new lesions. Clinical deterioration."|every 8 weeks until disease progression, estimated 18 months|||participants|||Number
131191|NCT00544817|Secondary|Overall Survival|Defined as Day 1 of protocol treatment to date of death from any cause.|18 months|||Months||95% Confidence Interval|Median
131192|NCT00544817|Primary|Progression-free Survival|Defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|18 months|||Months||95% Confidence Interval|Median
131193|NCT00544778|Primary|Response Rate|Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.|First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.|||percentage of patients responding|||Number
131194|NCT00544713|Secondary|Change From Baseline in Study Product Usage at Day 90|Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement).|Baseline, Day 90|Intent-to-Treat includes all patients that started the study and were randomized. Only those patients who reported actual eye drop use at Baseline and on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in arm 1 who reported eye drop use/number of patients in arm 2 who reported eye drop use).||Number of study product uses per day||Standard Deviation|Mean
131195|NCT00544713|Other Pre-specified|Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60|Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day.|Day 14, Day 60|Intent to Treat includes all patients that started the study and were randomized. Only those patients who were prescribed a dosing regimen at Day 14 to Day 60 visits were analyzed. The is indicated in parenthesis as (number of patients in arm 1 who were prescribed/number of patients in arm 2 who were prescribed).||Number of patients|||Number
131196|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90|Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Number of seconds||Standard Deviation|Mean
131197|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90|Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Scores on a Scale||Standard Deviation|Mean
131198|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90|Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 90|Intent to Treat population defined as all patients who started the study and were randomized||Scores on a Scale||Standard Deviation|Mean
131199|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Schirmer's Test at Day 90|Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Millimeters of Tears||Standard Deviation|Mean
131200|NCT00544713|Secondary|Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90|Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Microns||Standard Deviation|Mean
131201|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90|Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Units on a scale||Standard Deviation|Mean
131263|NCT00543985|Primary|Mean Resting E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants prior to treadmill stress test.|Immediately prior to exercise|The echo results from all subjects were analyzed at rest and following maximal exercise testing.||ml/min/kg||Standard Error|Mean
131202|NCT00544713|Secondary|Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90|Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement.|Baseline, Day 90|Intent-to-Treat population defined as all patients who started the study and were randomized||Units on a scale||Standard Deviation|Mean
131203|NCT00544713|Secondary|Best Corrected Visual Acuity (BCVA) Status at Day 90|"BCVA status at Day 90 reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more; No Change equals change between -2 to +2 lines; Worse equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly."|Day 90|Intent to Treat includes all patients who started the study and were randomized. One patient's status in the first arm was not available at Day 90 and was not evaluated for this outcome measure therefore only 113 patients were analyzed for this outcome measure.||Number of Patients|||Number
131204|NCT00544713|Secondary|Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study and were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).||Percentage of Patients|||Number
131205|NCT00544713|Secondary|Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90|"A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either Agree or Strongly Agree at day 90 was tabulated. The potential response categories included Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree and Strongly Disagree."|Day 90|Intent to Treat includes all patients who started the study are were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).||Percentage of Patients|||Number
131206|NCT00544713|Primary|Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90|Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).|Day 90|Intent to Treat population defined as all patients who started the study and were randomized||Scores on a Scale||Standard Deviation|Mean
131207|NCT00544674|Secondary|Pharmacokinetics||Days 1 and 2 of Cycles 1 and 4||||||
131208|NCT00544674|Primary|Safety and Tolerability: the Number of Subjects Experiencing a Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment|||participants|||Number
131209|NCT00544674|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of registration to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From registration of the first subject until radiological progression or recurrence whichever came first||||||
131210|NCT00544674|Secondary|Progression-free Survival|Progression free survival (PFS) is the time (days) from date of registration to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented.|Tumor measurements and assessments based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria were performed 6 weeks after first dose and as dictated by subject's malignancy||||||
131211|NCT00544674|Secondary|Survival||Every 3 months for 2 years after discontinuation||||||
131212|NCT00544674|Primary|Response Rate (Complete or Partial)||From registration until disease progression/recurrence||||||
131213|NCT00544648|Other Pre-specified|Secreted Protein Acidic and Rich in Cysteine (SPARC) Gene Expression|Secreted protein acidic and rich in cysteine (SPARC) gene expression in tumor specimens.|On receipt of tumor tissue blocks|Investigators elected not to perform this analysis.|||||
131214|NCT00544648|Secondary|Response (Phase II)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (n = 0) or if the patient is non-evaluable for best overall response (n = 1)||participants|||Number
131215|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase II)|The number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death|at 16 weeks|Treated patients who experienced a toxicity.||participants|||Number
131216|NCT00544648|Secondary|Overall Survival (Phase II)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details. Too few patients were enrolled in the Phase II arm for an analysis of overall survival|Time Frame: date on study to date of death from any cause or last known date alive|Too few patients were enrolled in the Phase II arm for an analysis of overall survival|||||
131217|NCT00544648|Secondary|Number of Patients With Each Worst Grade Toxicity (Phase I)|Count of patients according to the worst-grade toxicity (WGT) experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death.|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. One patient did not experience toxicity.||participants|||Number
131218|NCT00544648|Secondary|Response (Phase I)|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing (0) or if the patient is non-evaluable for best overall response (n = 1)||participants|||Number
131219|NCT00544648|Secondary|Overall Survival (Phase I)|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.||days||95% Confidence Interval|Median
131220|NCT00544648|Secondary|Progression-free Survival (Phase I)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.||days||95% Confidence Interval|Median
131221|NCT00544648|Primary|Progression-free Survival (Phase II)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause (assessed up to 2 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.||days||95% Confidence Interval|Median
131222|NCT00544648|Primary|Maximum Tolerated Dose of Nab-paclitaxel When Combined Concurrently With Carboplatin and Radiation (Phase I)|The highest dose in milligrams per meter of body surface squared (mg/m2) of nab-paclitaxel in combination with carboplatin while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of nab-paclitaxel in combination with carboplatin until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs per Common Toxicity Criteria v 3.0: recurring non-hematological (except esophagitis) > Grade 2, non-hematological or esophagitis > Grade 3 toxicities that are symptomatically unacceptable to patient and result in treatment delay for > 2 weeks, persistent toxicity resulting in treatment delay for > 2 weeks.|7 weeks|MTD based on clinical performance of those patients who received the study drug. One patient withdrew before receiving treatment. No formal statistical analysis, such as hypothesis testing, was performed.||mg/m2|||Number
131223|NCT00544557|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.||percentage of participants|||Number
131224|NCT00544557|Secondary|Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis|Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.||percentage of participants|||Number
131225|NCT00544557|Secondary|Duration of Healthcare Resources Utilization|Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants’ healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||days||Standard Deviation|Mean
131233|NCT00544557|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
131226|NCT00544557|Secondary|Healthcare Resource Utilization|Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants’ healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||events||Standard Deviation|Mean
131227|NCT00544557|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||percentage of impairment||Standard Deviation|Mean
131228|NCT00544557|Secondary|Euro Quality of Life (EQ­-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
131229|NCT00544557|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self­care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.|Baseline, Week 26, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
131230|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||percentage of participants||95% Confidence Interval|Number
131231|NCT00544557|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response|ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.|Week 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||percentage of participants||95% Confidence Interval|Number
131232|NCT00544557|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||mm/hr||Standard Deviation|Mean
131262|NCT00543985|Primary|Post-exercise E/E'|E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants immediately following treadmill stress test.|Immediately following treadmill stress test|The echo results from all subjects were analyzed at rest and following maximal exercise testing.||ml/min/kg||Standard Error|Mean
131234|NCT00544557|Secondary|Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||body parts||Standard Deviation|Mean
131235|NCT00544557|Secondary|Percentage of Participants With Presence of Enthesitis|Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||percentage of participants|||Number
131236|NCT00544557|Secondary|Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||joints||Standard Deviation|Mean
131237|NCT00544557|Secondary|Percentage of Participants With Presence of Peripheral Arthritis|Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||percentage of participants|||Number
131238|NCT00544557|Secondary|Percentage of Participants With Significant Reduction of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).|Week 2, 6, 12, 26, 38, 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.||percentage of participants|||Number
131239|NCT00544557|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 52|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||minutes||Standard Deviation|Mean
131240|NCT00544557|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52|Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
131241|NCT00544557|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52|Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
131242|NCT00544557|Secondary|Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52|Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
131243|NCT00544557|Secondary|Change From Baseline in Lateral Lumbar Flexion at Week 52|Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||cm||Standard Deviation|Mean
131244|NCT00544557|Secondary|Change From Baseline in Occiput-to-Wall Distance at Week 52|Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘n' signifies participants evaluable for this measure at given time points.||centimeter (cm)||Standard Deviation|Mean
131245|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0–10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0–10).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
131246|NCT00544557|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52|BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0–10 BASDAI score (0 being no problem and 10 being the worst problem).|Baseline, Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.||units on a scale||Standard Deviation|Mean
131247|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity||Baseline up to Week 52|Safety population included all treated participants with available post­-baseline safety data.||percentage of participants|||Number
131248|NCT00544557|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non­-SAEs.|Baseline up to Week 52|Safety population included all treated participants with available post-baseline safety data.||percentage of participants|||Number
131249|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 52|Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 52|Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ signifies participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
131250|NCT00544557|Primary|Percentage of Participants Achieving Partial Remission at Week 26|Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.|Week 26|Effectiveness population: all treated participants greater than or equal to (>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
131251|NCT00544544|Secondary|Clinical Global Impression Scale||6 weeks||||||
131252|NCT00544544|Secondary|Young Mania Rating Scale||6 weeks||||||
131253|NCT00544544|Secondary|Montgomery Asberg Depression Rating Scale||6 weeks||||||
131254|NCT00544544|Primary|Change in Hamilton Depression Rating Scale|The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. The best score is zero (reflecting no depression) and the worst score is 63 (reflecting severe depression).|Change from baseline to week 6|||units on a scale||95% Confidence Interval|Mean
131255|NCT00544440|Secondary|Number of Participants With Change in Markers of Bone Metabolism||Week 8|Data was reported in individual participant listings but not summarized due to statistical constraints.|||||
131256|NCT00544440|Primary|Difference in Bone Marrow Testosterone Levels Between Participants With and Without Serum Prostate Specific Antigen Decline||Week 8|Since there were too few participants with any detectable bone marrow testosterone, this analysis was not performed.|||||
131257|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.||Number of Participants|||Number
131258|NCT00544440|Primary|Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)||Baseline (predose Week 1 Day 1) and Week 8|Bone marrow aspirates were collected at baseline (predose Week 1 Day 1) in 49 participants and in 44 participants at Week 8.||Number of Participants|||Number
131259|NCT00544167|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.||18 Months|||percentage of patients|||Number
131260|NCT00543985|Secondary|Change in Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min) Measured in all participants immediately following treadmill stress test.|Immediately following treadmill stress test||||||
131261|NCT00543985|Secondary|Change in Maximal Oxygen Uptake (VO2 Max)|Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min). Measured in all participants prior to treadmill stress test.|Immediately prior to exercise||||||
132469|NCT00534105|Primary|Cholesterol|Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls|Postpartum|||mg/dl||Inter-Quartile Range|Mean
131264|NCT00543855|Primary|Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)|"J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.~ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and Week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Score on a scale||Standard Deviation|Mean
131265|NCT00543855|Primary|Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)|"CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from markedly improved” to “markedly worse”. Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and week 12|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Percentage of Participants|||Number
131266|NCT00543855|Primary|Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)|"NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method."|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Score on a scale||Standard Deviation|Mean
131267|NCT00543855|Primary|Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.|Baseline and every 4 weeks up to 12 weeks|Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.||Score on a scale||Standard Deviation|Mean
131268|NCT00543803|Secondary|Investigator's Global Clinical Assessment of Patient General Health Status|Investigators opinion of patients general health condition at baseline versus last evaluation on treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||participants|||Number
131269|NCT00543803|Secondary|Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator|Total number of patients with investigator defined non-serious drug-related AEs was reported.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||participants|||Number
131270|NCT00543803|Secondary|Summary of Change From Baseline in CD4+ Count to Last Value on Treatment||from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||(cells) / mm^3||Inter-Quartile Range|Median
131271|NCT00543803|Secondary|Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment|For calculation of this measure switch patients are included in the total which had no viral load decrease.|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||(log10 copies) / ml||Inter-Quartile Range|Median
131272|NCT00543803|Primary|Summary of Change From Baseline in Glucose to Last Value on Treatment|The change in Glucose from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
131273|NCT00543803|Primary|Summary of Change From Baseline in Triglycerides to Last Value on Treatment|The change in triglycerides from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
131274|NCT00543803|Primary|Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment|The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
131275|NCT00543803|Primary|Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment|The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
131276|NCT00543803|Primary|Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment|The change in total cholesterol from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
131277|NCT00543803|Primary|Summary of Change From Baseline in Creatinine to Last Value on Treatment|The change in Creatinine from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||mg/dl||Inter-Quartile Range|Median
131278|NCT00543803|Primary|Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment|The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||IU/L||Inter-Quartile Range|Median
131279|NCT00543803|Primary|Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment|The change in asparate aminotransferase (AST) from baseline to the last value in treatment|from baseline to last value on treatment in between 36 months|FAS- All patients were considered for the full analysis set.||IU/L||Inter-Quartile Range|Median
131282|NCT00543725|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The Intent-to-Treat analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome."||Participants|||Number
131283|NCT00543725|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||cells per microliter||95% Confidence Interval|Mean
131284|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 96|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 96. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
131285|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load < 400 HIV-1 (RNA) copies/mL at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 400 copies/mL after being responder) or who were never suppressed (no confirmed viral load <400 copies/mL).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
131286|NCT00543725|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per mL at the last on-treatment post-Week 96 visit.|Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz|Participants with at least 1 Post-Week 96 visit were included in the analysis.||Participants|||Number
131287|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
131288|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
131289|NCT00543725|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/mL (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/mL in the Wk 48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/mL and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
131290|NCT00543725|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
131291|NCT00543569|Secondary|Gastrointestinal Symptom Rating Scale Scores Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"||units on a scale||Standard Deviation|Mean
131307|NCT00543569|Secondary|Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12|The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.|Week 4, Month 6 and Month 12|"Full analysis set with available data at Week 4. N indicates the number of participants with available data at each time point."||mL/min per 1.73 m^2||Standard Deviation|Mean
131292|NCT00543569|Secondary|Gastrointestinal Quality of Life Index Score Over Time|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.|Months 1, 3, 6, and 12|"Full analysis set with available data at each time point (indicated by N)"||units on a scale||Standard Deviation|Mean
131293|NCT00543569|Secondary|Percentage of Participants With Treatment Failure at Month 6 and 12|Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131294|NCT00543569|Secondary|Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12|All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131295|NCT00543569|Secondary|Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12|"Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol.~The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131296|NCT00543569|Secondary|Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12|Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131297|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.~Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set||participants|||Number
131298|NCT00543569|Secondary|Maximum Grade of T-cell Mediated Rejection Assessed by Local Review|"The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.~Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation."|6 months and 12 months|Full analysis set||participants|||Number
131299|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Central Review|The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer||days||Full Range|Median
131300|NCT00543569|Secondary|Time to First T-cell Mediated BCAR Assessed by Local Review|The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.|12 months|Full analysis set with a T-cell mediated BCAR as assessed by local review||days||Full Range|Median
131301|NCT00543569|Secondary|Time to First BCAR Assessed by Central Review|The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR as assessed by the central reviewer||days||Full Range|Median
131302|NCT00543569|Secondary|Time to First BCAR Assessed by Local Review|The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.|12 months|Full analysis set with a BCAR assessed by local review||days||Full Range|Median
131303|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to central review, or lost to follow-up.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131304|NCT00543569|Secondary|Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review|Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to local review, or lost to follow-up.|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131305|NCT00543569|Secondary|Change From Week 4 in Serum Creatinine at Month 6 and 12||Week 4 and Month 6 and 12|"Full analysis set with available data at Week 4. N indicates participants with available data at each time point."||mg/dL||Standard Deviation|Mean
131306|NCT00543569|Secondary|Change From Week 4 in GFR by Iothalamate Clearance at Month 6|The glomerular filtration rate was measured directly using iothalamate clearance.|Week 4 and Month 6|"Full analysis set with available data at Week 4. N indicates participants with available data at Week 4 and Month 6."||mL/min per 1.73 m^2||Standard Deviation|Mean
131308|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131309|NCT00543569|Secondary|Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131310|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review|"Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131311|NCT00543569|Secondary|Percentage of Participants With BCAR at Month 12 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131312|NCT00543569|Secondary|Graft Survival at Month 6 and Month 12|"Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131313|NCT00543569|Secondary|Patient Survival at Month 6 and Month 12|"Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date.~The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit."|6 months and 12 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131314|NCT00543569|Primary|Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.~The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit."|6 months|Full analysis set||percentage of participants||90% Confidence Interval|Number
131315|NCT00543543|Secondary|Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|4 weeks postdose 3|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1 - Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range||Percentage of participants||95% Confidence Interval|Number
131316|NCT00543543|Secondary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection|Combined Incidence of HPV Type 31/33/45/52/58-related persistent infection as determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. Persistent infection was defined as infection detected in samples from >=2 consecutive visits 6 months (+/-1 month visit window) or longer apart. Incidence was defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.||Cases per 10,000 person-years follow-up|||Number
131317|NCT00543543|Primary|Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event.|Up to Month 6|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
131318|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. An AE that is judged by the investigator to be “definitely related,” “probably related,” or “possibly related” to the study drug is defined as a vaccine-related AE.|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
131319|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|Up to Day 15 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
131320|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Injection-site Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|Up to Day 5 after any vaccination|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
131321|NCT00543543|Primary|Base Study: Percentage of Participants With One or More Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)|The analysis population included all participants who received >=1 vaccination and had safety follow-up||Percentage of participants|||Number
131322|NCT00543543|Primary|Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58||Day 7 and Day 28 postdose 4 in the extension study||07/2017||||
131323|NCT00543543|Primary|Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.|4 weeks postdose 3 in the base study|The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range||milli Merck U/mL||95% Confidence Interval|Geometric Mean
131324|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|Up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.||Cases per 10,000 person-years follow-up|||Number
131325|NCT00543543|Primary|Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)|HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.|From Day 1 until >=30 cases accumulate, up to Month 54 in the base study|The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.||Cases per 10,000 person-years follow-up|||Number
131326|NCT00543296|Secondary|Number of Eyes With Increased Intraocular Pressure||52 weeks|||eyes|Participants||Number
131327|NCT00543296|Secondary|Number of Participant's Eye Requiring Adjunctive Therapy|Adjunctive Therapy needed to control inflammation in the implanted eye|5 years|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy||participant's eyes|Participants||Number
131328|NCT00543296|Secondary|Percentage of Eyes With Improvement in Visual Acuity|Visual acuity was improved by two or more lines from baseline.|baseline to 52 weeks|There were 14 participants studied with a total of 17 eyes implanted. Of the 17 eyes each could require separate adjunctive therapy||percentage of eyes improved|Participants||Number
131329|NCT00543296|Primary|Number of Eyes With Inflammation Recurrence|Number of eyes with inflammation recurrence|5 years|||eye with inflammation|Participants||Number
131330|NCT00543140|Secondary|Change in SF-36 Health Survey Mental Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||Unitless scale ranging 0 to 100||95% Confidence Interval|Mean
131331|NCT00543140|Secondary|Change in SF-36 Health Survey Physical Component at 5 Years Post Implant|Scores on the SF-36 Health Survey are determined by methodology publised with the validated instrument. Scores can range from 0 to 100 with higher scores indicating higher quality of life.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||unitless scale ranging 0 to 100||95% Confidence Interval|Mean
131332|NCT00543140|Secondary|Percent Change in Excess Body Weight at 5 Years Post-implant||5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||percentage of excess body weight||95% Confidence Interval|Mean
131333|NCT00543140|Secondary|Change in Glycosylated Hemoglobin (HbA1c) at 5 Years Post Implant.|The natural unit of measurement for HbA1c is percent (%). Results provided represent change from baseline, that is, Year 5 value minus Baseline value.|5 years|All subjects providing a measurement at the 5 year visit. No imputation of missing data was performed.||percentage||95% Confidence Interval|Mean
131334|NCT00543140|Primary|Re-operation Rate (Band Revision, Band Replacement and Explants Resulting From Serious Adverse Device-related Event {SADE}) of Gastric Banding at 4 and 5 Years Post Implant.|"A reoperation was identified by satisfying all of the following criteria:~Is an SAE or is the action taken as the result of an SAE;~Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device;~Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight loss, subject request, and other non-medical conditions will not be counted); and~Has a start date that is strictly more than 1095 days (3 years) from the implantation of the device."|5 years|Consists of subjects who had a device implanted under protocol CI-07-0006 and subjects implanted under protocol CI-02-0006 and subsequently enrolled under protocol CI-06-0001.||percentage of subjects||95% Confidence Interval|Number
131335|NCT00543101|Secondary|Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)|Participants in the experimental arm completed treatment satisfaction questionnaires at 24 weeks, and the control arm at 48 weeks (24 weeks after mid-study crossover to boosted darunavir). The questionnaires used numeric satisfaction scales (+3 much more satisfied now to -3 much less satisfied now). We reported the median and ranges for each question for each study arm.|24 weeks|||Units on a Scale (+3 to -3)||Full Range|Median
131336|NCT00543101|Secondary|Lipid Fraction Results, Mean of the Change From Baseline to Week 24.|We collected fasting total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides from all participants in both arms of the study. We calculated the differences between the values at week 24 and baseline for the participants in both arms. We reported the mean of the change from baseline to week 24.|baseline and 24 weeks|||mg/dL|||Number
131337|NCT00543101|Secondary|Economic Impact of a Substitution of Dual Boosted PIs With DRV/r|To assess the economic impact of DRV/r substitution for dual boosted PIs, we compared the average wholesale acquisition costs for the drugs in US Dollars ($) per month. The wholesale acquisition cost in US dollars ($) for each ART regimen was determined and the difference between the cost for the experimental and control groups was calculated and reported as US dollar savings per month.|48 weeks|||US dollars savings per month|||Number
131338|NCT00543101|Primary|The Percentage of Participants With Successful Virologic Suppression|Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as < 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.|24 weeks|||Percentage of Participants|||Number
131339|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUCτ) of Total Serum IgG|AUCτ = Area under the concentration-time curve during regular dosing interval;|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population. 7 subjects were missing data for AUCτ.||day x g/L||Standard Deviation|Mean
131340|NCT00542997|Other Pre-specified|Area Under the Concentration-Time Curve (AUC_last) of Total Serum IgG|AUC_last = Area under the concentration-time curve until last measured concentration.|Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.||day x g/L||Standard Deviation|Mean
131341|NCT00542997|Other Pre-specified|Timepoint of Maximum Concentration (Tmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.||day||Full Range|Median
131342|NCT00542997|Other Pre-specified|Maximum Concentration (Cmax) of Total Serum IgG||Week 28 (±1week)|Per Protocol Pharmacokinetic (PPK) population analysis. A total of 24 of the 51 enrolled subjects were included in a pharmacokinetic (PK) sub-study. 23 subjects completed the PK sub-study per protocol and were included in the PPK analysis population.||g/L||Standard Deviation|Mean
131343|NCT00542997|Secondary|Annual Rate of Antibiotic Use for Infection Prophylaxis and Treatment|The annual rate was calculated based on the total number of days of antibiotic use in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.~The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."||days/subject/year|Participants||Number
131344|NCT00542997|Secondary|Annual Rate of the Number of Days of Hospitalization Due to Infections|The annual rate was calculated based on the total number of days of hospitalization due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|"ITT population analysis.~The intention-to-treat (ITT) data set comprises all subjects treated with the study drug during the efficacy period (week 13 to week 40 after study start or to the completion visit)."||days/subject/year|Participants||Number
131345|NCT00542997|Secondary|Annual Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annual rate was calculated based on the total number of days out of work/school/kindergarten/day care or unable to perform normal activities due to infections in the efficacy period divided by the total number of days in the efficacy period for all subjects and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).||days/subject/year|Participants||Number
131499|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131346|NCT00542997|Secondary|Annual Rate of Infection Episodes|The annual rate of episodes was calculated based on the total number of any infection type and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days.|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).||episodes/subject/year|Participants|95% Confidence Interval|Number
131347|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (PPE Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.~The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the PPE population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Per Protocol Efficacy (PPE) population analysis. The PPE population included all subjects who completed the 28-week efficacy period according to protocol.||SBIs/subject/year|Participants||Number
131348|NCT00542997|Secondary|Annual Rate of Clinically Documented Serious Bacterial Infections (ITT Population)|"Serious bacterial infections (SBIs) included bacterial pneumonia, bacteraemia/septicaemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. Diagnosis of the SBIs was based on the presence of predefined clinical signs and symptoms as well as on laboratory parameters.~The annual rate was calculated based on the total number of SBIs and the total number of study days during the efficacy period for all subjects in the ITT population and adjusted to 365 days."|Efficacy period: week 12 to week 40 after study start or to the completion visit|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12).||SBIs/subject/year|Participants||Number
131349|NCT00542997|Primary|Total Serum IgG Trough Levels|Total IgG trough levels for IgPro20 treatment at steady state were compared with documented trough level data for IgG treatment received prior to enrolling in the study (either subcutaneous or intravenous IgG). For this purpose, 6 consecutive IgPro20 trough values (obtained prior to infusions 12 to 17) per subject were aggregated to the subject’s median value and then median values across subjects were summarised using descriptive statistics. The same procedure was applied to pre-study treatment using the 3 most recent IgG trough values ≥ 5 g/L obtained prior to the first IgPro20 infusion.|Up to 6 months prior to first IgPro20 treatment (Pre-study treatment) and Week 12 to 17 (IgPro20 treatment)|Intention-to-treat (ITT) population analysis. The ITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 12). For 2 subjects in the ITT population, the pre-study treatment IgG trough levels were not available.||g/L||Standard Deviation|Mean
131350|NCT00542971|Secondary|Number of Participants With Complete Response|Complete response was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L platelets in the peripheral blood (PB).|Baseline to 2 years or disease progression.|||Participants|||Number
131351|NCT00542971|Primary|Maximum Tolerated Dose (MTD)|MTD is dose level where grade 3-4 sorafenib-attributable toxicity in <2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.|Twice a week for first two 28 day cycles|10 participants were treated with escalating doses of sorafenib with chemotherapy to establish the feasibility of the combination.||milligrams/twice a day (BID)|||Number
131352|NCT00542880|Secondary|The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Units on a scale||Standard Deviation|Mean
131353|NCT00542880|Secondary|Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Units on a scale||Standard Deviation|Mean
131354|NCT00542880|Secondary|Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||units on a scale||Standard Deviation|Mean
131355|NCT00542880|Secondary|Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
131356|NCT00542880|Secondary|Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic|The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.|Baseline (run-in, and washout) and day 1 of treatment period|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
131370|NCT00542828|Secondary|Number of Participants With Transformation to Acute Myeloid Leukemia|This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of >=20% after the start of treatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131357|NCT00542880|Secondary|Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
131358|NCT00542880|Secondary|Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
131359|NCT00542880|Secondary|Change in PEF From Before Dose to 15 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
131360|NCT00542880|Secondary|Change in PEF From Before Dose to 5 Minutes After Dose in the Morning|The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
131361|NCT00542880|Secondary|FEV1 Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
131362|NCT00542880|Secondary|FEV1 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
131363|NCT00542880|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated.||Liters||Standard Deviation|Mean
131364|NCT00542880|Secondary|PEF Before Evening Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
131365|NCT00542880|Secondary|PEF 15 Minutes After Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minute||Standard Deviation|Mean
131366|NCT00542880|Secondary|PEF Before Morning Dose|The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||Liters/minutes||Standard Deviation|Mean
131367|NCT00542880|Primary|Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose|The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.|Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days|Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated.||liters/minute||Standard Deviation|Mean
131368|NCT00542828|Secondary|Number of Participants With a Marrow Remission|This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of <=5% myeloblasts and decrease by >=50% over pretreatment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131369|NCT00542828|Secondary|Number of Participants With a Cytogenetic Response|This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131500|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population||Week 52|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131371|NCT00542828|Secondary|Number of Participants With Progression-free Survival|This is a measure of a progression-free survival which is defined as the time from the participant’s first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131372|NCT00542828|Secondary|Number of Participants With a Relapse Following Overall Remission|This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of >=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by >=1.5 g/dL from maximum remission levels; or transfusion dependence.|36 months|Secondary outcome measure was not formally analyzed or assessed due to early study termination and small sample size (i.e., no study participants reached the 36-month time point)|||||
131373|NCT00542828|Secondary|Number of Participants With a Relapse Following HI|This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: >=50% decrease from maximum response levels in granulocytes or platelets; >=1.5 g/dL reduction in hemoglobin; or transfusion dependence.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131374|NCT00542828|Secondary|Number of Participants With Duration of Transfusion Independence|This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131375|NCT00542828|Secondary|Number of Participants Who Achieved Transfusion Independence|This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131376|NCT00542828|Secondary|Duration of Disease Remission|This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131377|NCT00542828|Secondary|Number of Participants Who Achieved Disease Remission|Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow <=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin >=11 g/dL, platelets >=100 x 10^9/L, neutrophils >=1.0 x 10^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by >=50% over pretreatment, but still >5%; and cellularity and morphology not relevant.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131378|NCT00542828|Secondary|Number of Participants With Duration of HI|This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first.|36 months|This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).|||||
131379|NCT00542828|Primary|Number of Participants Who Achieved Hematologic Improvement (HI)|This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a >=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been <11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of >=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria.|12 months|Number of participants analyzed includes those who received treatment with Thymoglobulin and completed follow-up efficacy assessments. However, no formal efficacy analysis was conducted due to the small sample size and early study termination.||participants|||Number
131380|NCT00542815|Secondary|The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer|Percent Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.||percentage change of LDL-cholesterol||Standard Deviation|Mean
131381|NCT00542815|Primary|The Change in Serum Phosphorus for MCI-196 and Sevelamer|Change from Baseline to Week 52 (LOCF)|52 weeks (Baseline-52 weeks)|ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.||mg / dL||Standard Deviation|Mean
131382|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment|up to 12 weeks|||Participants|||Number
131383|NCT00542789|Secondary|Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment|The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment|up to 4 weeks|||Participants|||Number
131384|NCT00542789|Primary|Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period|The absence of gastric and/or duodenal ulcer throughout the treatment period|each visit up to 24 weeks|Two participants were excluded from these sets because they took no investigational drug or had major protocol deviation. As the result, the numbers of participants for gender baseline were 173 in Esomeprazole 20 mg and 168 in Placebo, respectively.||Participants|||Number
131385|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Very Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||percentage of subjects|||Number
131386|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Happy Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||percentage of subjects|||Number
131387|NCT00542620|Secondary|"Percentage of Children Assessing Insulin Therapy Injection Pain as Sad Face"|Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.|Week 0 and Week 8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||percentage of subjects|||Number
131388|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L|Number of “symptoms only” hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||episodes|||Number
131389|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L|Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||episodes|||Number
131390|NCT00542620|Secondary|Incidence of Hypoglycaemic Episodes - All Episodes|Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator’s judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-8|All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.||episodes|||Number
131391|NCT00542620|Secondary|Body Mass Index (BMI) Z Score|Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||Z-score||Standard Deviation|Mean
131392|NCT00542620|Secondary|Weight Z Score|Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||Z-score||Standard Deviation|Mean
131393|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
131394|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
131395|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
131396|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
131397|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Aspart|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol/L||Standard Deviation|Median
131501|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131398|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects||hours||Standard Deviation|Median
131399|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects||pmol.h/L||Standard Deviation|Median
131400|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
131401|NCT00542620|Secondary|Pharmacokinetics: Tmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
131402|NCT00542620|Secondary|Pharmacokinetics: Cmax of Insulin Detemir|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol/L||Standard Deviation|Median
131403|NCT00542620|Secondary|Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects||hours||Standard Deviation|Median
131404|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.||pmol.h/L||Standard Deviation|Median
131405|NCT00542620|Secondary|Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol.h/L||Standard Deviation|Median
131406|NCT00542620|Secondary|Pharmacokinetics: Tmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||hours||Standard Deviation|Median
131407|NCT00542620|Secondary|Pharmacokinetics: Cmax of Free Insulin|The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||pmol/L||Standard Deviation|Median
131408|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.||mg/dL||Standard Deviation|Mean
131409|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Dinner)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mg/dL||Standard Deviation|Mean
131410|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (After Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mg/dL||Standard Deviation|Mean
131411|NCT00542620|Secondary|Self-measured Plasma Glucose Profile (Before Breakfast)||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mg/dL||Standard Deviation|Mean
131412|NCT00542620|Secondary|Fructosamine||Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||mmol/L||Standard Deviation|Mean
131502|NCT00541658|Secondary|Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population||Week 13|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131413|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the ITT (Intention-to-Treat) set|Week 0 and Week 8|Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.||percentage of total haemoglobin||Standard Deviation|Mean
131414|NCT00542620|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol (PP) set|Week 0 and Week 8|Per Protocol (PP) analysis set consists of all the ITT (Intention-to-Treat) subjects who did not present any significant protocol deviations that could potentially affect the efficacy results. One subject was excluded from PP as subject received separate injections despite being randomised to receive mixed injections.||percentage of total haemoglobin||Standard Deviation|Mean
131415|NCT00542542|Primary|Proportion of Participants With No Pain Immediately After Surgery|Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 – 24 hours post-operatively).|Starting immediately after surgery, every 2 hours till the 6th hour following surgery|Analysis was not possible from data collected due to reporting inconsistencies.|||||
131416|NCT00542425|Secondary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.|12 months|The extension population included any patient who continued in the extended 24 weeks of treatment; N=55. 49 of the 55 extension patients had data available for analysis at Week 48.||Percent change from baseline||Standard Deviation|Mean
131417|NCT00542425|Secondary|Change in Bone Mineral Density, Total Hip.|Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
131418|NCT00542425|Secondary|Change in Bone Mineral Density, Femoral Neck.|Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 182 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
131419|NCT00542425|Primary|Change in Bone Mineral Density, Total Spine.|Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 187 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
131420|NCT00542425|Primary|Change in Marker of Bone Metabolism, PINP|PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.|6 months|The intent to treat (ITT) population included any patient who received at least one dose of study medication; N=221. 193 of the 221 ITT patients had data available for analysis at Week 24.||Percent change from baseline||Standard Deviation|Mean
131421|NCT00542386|Secondary|The Incidence of Adverse Events||12 weeks||||||
131422|NCT00542386|Secondary|The Change in Ca x P Ion Product||12 weeks||||||
131423|NCT00542386|Secondary|The Change in Ca||12 weeks||||||
131424|NCT00542386|Secondary|The Change in PTH||12 weeks||||||
131425|NCT00542386|Secondary|The Change in Triglycerides||12 weeks||||||
131426|NCT00542386|Secondary|The Change in HDL-cholesterol||12 weeks||||||
131427|NCT00542386|Secondary|The Change in Total-cholesterol||12 weeks||||||
131428|NCT00542386|Primary|The Change in LDL-cholesterol|The percentage change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start of study medication.||Percent change||Standard Deviation|Mean
131429|NCT00542386|Primary|The Change in Serum Phosphorus|The change from baseline to week 12|12 weeks|ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start||mg/dL||Standard Deviation|Mean
131430|NCT00542321|Secondary|Turning-related Events|Non-serious adverse events that occurred during the time of rotation in the kinetic therapy bed group and during lateral rotation to right or left position in the manual turn group|Participants were followed for the duration of time on protocol, an average of 3.5 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died after enrollment but before protocol could be initiated)||Events||Standard Deviation|Mean
131431|NCT00542321|Secondary|ICU All-cause Mortality.|Death from any reason between admission and discharge from study ICU|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in the kinetic therapy bed group and 7 of the 8 patients enrolled in the manual turn group (1 patient died before start of study protocol)||participants|||Number
131432|NCT00542321|Secondary|ICU Length of Stay.|Time in days from study ICU admission to study ICU discharge or death|Participants were followed for the duration of ICU stay, an average of 10 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 patient enrolled but died before started on protocol)||Days||Inter-Quartile Range|Median
131433|NCT00542321|Secondary|Mechanical Ventilation Duration.|Days on mechanical ventilation, from initiation to withdrawal of mechanical ventilation|Participants were followed for the duration of mechanical ventilation, an average of 5.5 days.|All 8 patients enrolled in kinetic therapy bed group and 7 of 8 patients enrolled in manual turn group (1 death before study protocol initiated)||Days||Standard Deviation|Mean
131434|NCT00542321|Primary|Incidence of Pulmonary Complications.|Number of participants who did not have preventable pulmonary complications (PPC) on pre-study chest radiograph (CXR) and developed PPC during the study period. Pearson Chi-Square test used to test significance of difference between turning groups.|Participants were followed for the duration of ICU stay, an average of 10 days.|Intention to treat; all 8 patients enrolled in kinetic therapy bed turn and 7 of 8 patients enrolled in manual turn (1 died before protocol initiated)||participants|||Number
131503|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
131435|NCT00542308|Secondary|Tumour Response|Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0)J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|During treatment and two weeks after end of treatment, assessed up to 21 months.|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.||participants|||Number
131436|NCT00542308|Primary|Overall Survival|Overall survival was defined as time from start of treatment until date of death of any cause.|From randomization until death, assessed up to 21 months|All patients attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.||months||95% Confidence Interval|Median
131437|NCT00542269|Secondary|Percentage of Patients Who Developed Diabetes at End of Study|A patient had diabetes if fasting plasma glucose > 7 mmol/L.|Week 12|Intent-to-treat (ITT) population: All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the primary efficacy variable.||Percentage of patients|||Number
131438|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/mol||Standard Error|Least Squares Mean
131439|NCT00542269|Secondary|Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine||Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/mol||Standard Error|Least Squares Mean
131440|NCT00542269|Secondary|Change in HOMA-β From Baseline to End of Study|Homeostasis model assessment-β (HOMA-β) was defined as fasting insulin (μU/mL) x 20 / (fasting glucose (mmol/L) - 3.5).|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/L||Standard Deviation|Mean
131441|NCT00542269|Secondary|Change in HOMA-IR From Baseline to End of Study|Homeostasis model assessment-insulin resistance (HOMA-IR) was defined as (fasting insulin [μU/mL] x fasting glucose [mmol/L]) / 22.5.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmol/L||Standard Deviation|Mean
131442|NCT00542269|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study|Normalized was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||Percentage of patients|||Number
131443|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmHg||Standard Error|Least Squares Mean
131444|NCT00542269|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msDBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmHg||Standard Error|Least Squares Mean
131445|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|Intent-to-treat (ITT) population. All patients that received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment of the variable.||mmHg||Standard Error|Least Squares Mean
131446|NCT00542269|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)|Automated blood pressure determinations were made with the Omron HEM-705CP blood pressure monitor at trough (24 hours ± 3 hours post-dose) and recorded at all study visits following detailed directions specified in the study protocol. Three readings were made and msSBP was calculated as the average of the 3 readings. In the event of aberrant readings, ie, the lowest reading was ≥ 10 mmHg systolic or ≥ 5 mmHg diastolic lower than the highest of the 3 readings, 3 additional readings were obtained. A negative change indicates improvement.|Baseline to Week 12|||mmHg||Standard Error|Least Squares Mean
131447|NCT00542178|Secondary|Loss of Visual Acuity, Cataract Extraction, or Development or Progression of Macular Edema||Measured at Year 4||05/2013||||
131504|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131505|NCT00541658|Secondary|Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131448|NCT00542178|Primary|Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy|Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.|Measured at Year 4|||participants|||Number
131449|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
131450|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131451|NCT00541970|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131452|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
131453|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131454|NCT00541970|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131455|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
131456|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131457|NCT00541970|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs)|NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131458|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
131459|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 48.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131460|NCT00541970|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.|From Month 0 to Month 7.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131461|NCT00541970|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.|Within 30 days (Day 0-29) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131462|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|Throughout the study period, from Month 0 to Month 60.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||Subjects|||Number
131463|NCT00541970|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.|From Month 0 to Month 48.|The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
131464|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e. titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 19 ELISA units per milliliter (EL.U/mL). Seronegative subjects are subjects who had an antibody concentration below cut-off value.|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
131465|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).|At Month 60 of the safety follow-up phase|The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
131466|NCT00541970|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)|Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
131467|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents PLA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131468|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents WBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, on subjects with available results.||subjects|||Number
131469|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents RBC results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131470|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents NEU results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131471|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents MON results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131472|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents LYM results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131473|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents ALT results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131474|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents Hct results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131475|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents EOS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131476|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range.This outcome presents CREA results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131487|NCT00541775|Primary|Hemoglobin A1C (A1C) at Week 18|"A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.~The study hypothesis comparison was between sitagliptin versus placebo."|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
131477|NCT00541970|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.|At Month 7 (M7)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131478|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
131479|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects eligible for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
131480|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.|At Month 7, 1 month after the last dose of vaccine or placebo.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
131481|NCT00541970|Secondary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.|At Month 3, 1 month after the second dose of vaccine or placebo|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
131482|NCT00541970|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131483|NCT00541970|Primary|Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (>) 50 millimeters (mm).|Within 7 days (Day 0-6) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.||subjects|||Number
131484|NCT00541970|Primary|Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
131485|NCT00541775|Secondary|2-hour Post-meal Glucose (PMG) at Week 18|The change from baseline is the Week 18 PMG minus the Week 0 PMG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
131486|NCT00541775|Secondary|Fasting Plasma Glucose (FPG) at Week 18|The change from baseline is the Week 18 FPG minus the Week 0 FPG.|Baseline and 18 Weeks|The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
131488|NCT00541671|Primary|Number of Patients Who Became Nauseated After IV Opiate Administration.||4 hours post opiate administration|||participants|||Number
131509|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
131510|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131511|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131512|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131513|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population||Week 26|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131514|NCT00541658|Secondary|Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population||Week 13|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131515|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
131516|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population||Week 104|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131517|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131518|NCT00541658|Secondary|Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population||Week 52|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131519|NCT00541658|Secondary|Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131520|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. LOCF at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
131521|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population||Week 104|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131522|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. LOCF at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131523|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131524|NCT00541658|Secondary|Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population||Week 26|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131525|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
131526|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population||Week 104|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131527|NCT00541658|Secondary|Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131528|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population||Week 52|ITT Population.||Percent||95% Confidence Interval|Least Squares Mean
131529|NCT00541658|Secondary|Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population||Week 26|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
131530|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percentage of Participants|||Number
131531|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population||Percentage of Participants|||Number
131532|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52 / Endpoint|ITT Population. Last Observation Carried Forward at Week 52.||Percentage of Participants|||Number
131533|NCT00541658|Secondary|Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population|Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.|Week 52|ITT Population.||Percentage of Participants|||Number
131534|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population||Week 104 / Endpoint|ITT Population. Last Observation Carried Forward at Week 104.||Percent Change||95% Confidence Interval|Least Squares Mean
131535|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population||Week 104|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131536|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population||Week 52|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131537|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population||Week 26|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
131573|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Physical (PCS-8) and Mental (MCS-8) Quality of Life at Week 6 as Measured by the 2 Subscales of the Short Form (SF)-8||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
131538|NCT00541658|Secondary|Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population||Week 52 / Endpoint|35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131539|NCT00541658|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population||52 weeks / Endpoint|Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.||Percent Change||95% Confidence Interval|Least Squares Mean
131540|NCT00541593|Primary|Mortality|"Number of patients who died as a result of the surgery: Death (mortality).~Please note that pain was previously listed as an outcome measure, but this was edited out of this submission and was not tracked as an outcome measure."|One year|Patients who had the diagnosis, qualified anatomically, and were interested in the research study (and who met inclusion criteria but not exclusion criteria) were enrolled.||participants|||Number
131541|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in FPG compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for FPG.||mg/dL||95% Confidence Interval|Least Squares Mean
131542|NCT00541450|Secondary|Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in FPG compared to baseline was measured for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and (2) had a baseline measurement and at least one on-treatment measurement for FPG.||mg/dL||95% Confidence Interval|Least Squares Mean
131543|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the participants treated with Sitagliptin or Pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. To calculate Least Squares, the ANCOVA model included a term for treatment and the baseline value as a covariate.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for PMG.||mg/dL||95% Confidence Interval|Least Squares Mean
131544|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks|The change in A1C compared to baseline was measured for the participants treated with sitagliptin or pioglitazone at Week 12. Sitagliptin was the only intervention administered to the Sita/Met FDC group during this phase. A1c represents percentage of glycosylated hemoglobin.|Baseline to 12 weeks|All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12; and (2) had a baseline measurement and at least one on-treatment measurement for A1C.||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
131545|NCT00541450|Secondary|Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks|The change in PMG compared to baseline was measured using the Meal Tolerance Test (MTT) for the Sita/Met FDC and the pioglitazone groups at Week 40.|Baseline and 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and~(2) had a baseline measurement and at least one on-treatment measurement for PMG."||mg/dL||95% Confidence Interval|Least Squares Mean
131546|NCT00541450|Primary|Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 Weeks|The change in A1C, compared to baseline for the Sita/Met FDC and the pioglitazone groups at Week 40. A1C represents percentage of glycosylated hemoglobin.|Baseline to 40 weeks|"All randomized participants who (1) took at least one dose of study medication; i.e., sitagliptin or pioglitazone 15/30 mg q.d. for the Weeks 0-12, and Sita/Met FDC or pioglitazone 45 mg q.d. for the Weeks 0-40 (Phase A and Phase B); and~(2) had a baseline measurement and at least one on-treatment measurement for A1C."||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
131547|NCT00541346|Secondary|Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit|This instrument is a teacher rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131548|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Social-Function scale score ranges from 0 to 25. A higher score indicates a higher degree of independence in the Social-Function area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131574|NCT00540969|Secondary|Average Difference in Pre- and Post-treatment Average Pain, Pain Relief, and Pain Interference Scores at Week 6 as Measured With the BPI||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
131549|NCT00541346|Secondary|Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit|The PEDI Caregiver Assistance measures rate the child's function in three domains: Self-care, Mobility, and Social Function. Items are scored 0 (total, where the child is completely dependent on assistance) to 5 (independent, where no assistance is given or required). Scale scores represent summed item scores within each domain. The Self-Care scale score ranges from 0 to 40. A higher score indicates a higher degree of independence in the self-care area.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131550|NCT00541346|Secondary|Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit|The Family Assessment measure is a self-report instrument that provides quantitative indices of family strengths and weaknesses. Each items is rated 0 (strongly agree) to 3 (strongly disagree). The General scale produces seven subscales: task accomplishment, role performance, communication, affective expression, involvement, control and values and norms. The minimum score for each subscale is 0 while the maximum score is 15. Higher raw scores indicate a higher number of family problems reported. A total summed score of all scale scores was used in the analyses described below. The possible range of this total score was 0 to 105. Like the subscales, higher values for this total summed score indicate a higher number of family problems reported.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131551|NCT00541346|Secondary|Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit|The LPS was developed to capture treatment-related improvements in adaptive functioning including quality of life, social development, and emotion regulation. There are 24 items scored using a 4-point Likert frequency scale (0=Never or Seldom, 1=Sometimes, 2=Often, 3=Very Often). A summed scale score (possible range of 0 to 72) was used in the analyses described below. Higher scores indicate more adaptive functioning.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131552|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 4 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum is 12 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131553|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 7 of these items comprise the stereotypic behavior factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 21 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131554|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the lethargy/social withdrawal factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131555|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 15 of these items comprise the irritability/agitation/crying factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 45 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131556|NCT00541346|Secondary|Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit|The ABC is a behavior rating scale administered by the clinician which is designed to measure behavior changes brought about by drug treatment effects. 16 of these items comprise the hyperactivity, noncompliance factor. Each item is scored on a 3 point scale where 0 indicates the behavior is not a problem and 3 indicates the behavior problem is severe in degree. The minimum score on this factor is 0 (no behavior problems) while the maximum score is 48 ( severe behavior problems).|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week assessment was used to handle missing data for a single drop-out participant who left the study after the 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131575|NCT00540969|Primary|Comparison of Pre- and Post-treatment Worst Pain in 24 Hours at Week 6 as Measured on the Numeric 0 to 10 Brief Pain Inventory (BPI) Scale||at week 6|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.|||||
131557|NCT00541346|Primary|Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit|This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.|Baseline, 8 weeks|Intention to Treat (ITT). Bayesian posterior-predictive imputation of the 8th-week follow-up assessment was used to handle missing data for a single drop-out participant who left the study after a 2nd follow-up visit.||units on a scale||Standard Deviation|Mean
131558|NCT00541307|Secondary|Device-related Major Adverse Events at 12 Months|If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|12 months|||event|||Number
131559|NCT00541307|Secondary|Secondary Patency|Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency.|12 months|||percentage of subjects||95% Confidence Interval|Number
131560|NCT00541307|Secondary|Primary Assisted Patency|Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency.|12 months|||percentage of subjects||95% Confidence Interval|Number
131561|NCT00541307|Secondary|Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days|If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death.|30 days|||participants|||Number
131562|NCT00541307|Primary|Primary Patency at 12 Months|Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area).|12 months|||percentage of subjects||95% Confidence Interval|Number
131563|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 18|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.||millimeters of mercury (mmHg)||Standard Deviation|Mean
131564|NCT00541242|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12|Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Week 12|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.||millimeters of mercury (mmHg)||Standard Deviation|Mean
131565|NCT00541229|Primary|24-hour Weighted Mean Glucose (WMG)|The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.|Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.|The per-protocol (PP) population consisted of all patients randomized who had a measurement at Day 7 in Treatment Period I and did not have any major protocol violations. Missing data were not imputed.||mg/dL||95% Confidence Interval|Least Squares Mean
131566|NCT00541190|Secondary|Mucociliary Clearance Rate|"Mucociliary clearance rate represents the rate at which the lungs clear an inhaled particulate. Here it specifically represents the percentage of inhaled Technetium 99m sulfur colloid cleared from the lungs over a 60 minute period. This is reported based on whole lung areas to allow comparisons with previous studies."|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.||percentage lung clearance per hour||Standard Deviation|Mean
131567|NCT00541190|Primary|Absorptive Clearance Rate|The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways.|single measurement|No formal power analysis was performed for this pilot study. Two subjects (one CF, one control) were identified as obvious outliers with whole lung Tc-SC clearance rates more than two standard deviations above the average of the group. These outliers were excluded from further analyses.||percentage of DTPA absoprtion per hour||Standard Deviation|Mean
131568|NCT00541099|Secondary|Toxicity||1st and 2nd week of each 21 day cycle||||||
131569|NCT00541099|Secondary|Response Rate||Every 8 weeks||||||
131570|NCT00541099|Secondary|Overall Survival||4 weeks after removal from study or until death||||||
131571|NCT00541099|Secondary|Progression-free Survival||6 months when treated with combination of Avastin and weekly docetaxel||||||
131572|NCT00541099|Primary|Survival||6 months when treated with combination of Avastin and weekly docetaxel|||percentage of participants surviving||90% Confidence Interval|Number
131576|NCT00540644|Secondary|Quality of Life Using the FACT-G Data|"Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided.~Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome"|baseline and after last cycle (up to 6 cycles)|All patients enrolled and received treatment with a baseline and post-baseline measurement.||scores on a scale||Standard Deviation|Mean
131577|NCT00540644|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Beginning of treatment up to 5 years|All patients enrolled and received treatment.||participants|||Number
131578|NCT00540644|Primary|Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria|Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.|After 6 cycles|All patients receiving at least one dose of study drug and having at least one post-baseline visit||percentage of participants||95% Confidence Interval|Number
131579|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
131580|NCT00540592|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
131581|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 21 and Day 179 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
131582|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.|Between Day 0 and Day 20 after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
131583|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
131584|NCT00540592|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.||Days||Full Range|Median
131585|NCT00540592|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature >40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
131586|NCT00540592|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.||Days||Full Range|Median
131587|NCT00540592|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. > 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
131588|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
131589|NCT00540592|Secondary|The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.||cells per million CD8 T-cells||Standard Deviation|Geometric Mean
131590|NCT00540592|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180|The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 180.||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
131591|NCT00540592|Secondary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21|The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
131592|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||Subjects|||Number
131593|NCT00540592|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||Subjects|||Number
131594|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 180|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||fold increase||95% Confidence Interval|Geometric Mean
131595|NCT00540592|Secondary|HI Antibody Seroconversion Factors at Day 21|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||fold increase||95% Confidence Interval|Geometric Mean
131596|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||Subjects|||Number
131597|NCT00540592|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||Subjects|||Number
131791|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy|Percentage change in specific tumor marker (Carcinoembryonic antigen, CEA) levels in response to neoadjuvant therapy|Baseline and 2 years|||percent change||Full Range|Median
131598|NCT00540592|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.||titer||95% Confidence Interval|Geometric Mean
131599|NCT00540592|Secondary|HI Antibody Titers at Day 0 and Day 21|Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||titer||95% Confidence Interval|Geometric Mean
131600|NCT00540592|Primary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.||titer||95% Confidence Interval|Geometric Mean
131601|NCT00540579|Primary|The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0|The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)|24 Months|All patients treated with pomalidomide and gemcitabine were assessed for Grade 3/4 toxicities||percentage of patients||95% Confidence Interval|Number
131602|NCT00540579|Primary|Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects|"Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows:~Inability to Complete cycle 1 of therapy due to drug-related toxicity.~> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care~Febrile neutropenia (absolute neutrophil count [ANC] <1,000/μL and fever >101° F (38.5° C))~Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT)~Platelet count < 25,000/μL~Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity."|6 months|Two patients withdrew consent and were unevaluable for DLT. One patient suffered subdural hematoma (non-treatment related) and was unevaluable for DLT.||milligrams|||Number
131603|NCT00540514|Other Pre-specified|Time to Improvement of ≥ Grade 3 Treatment Related Peripheral Neuropathy|"Peripheral neuropathy was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.~Improvement in peripheral neuropathy was evaluated as:~Time to improvement of grade 3 or higher peripheral neuropathy by at least one grade;~Time to improvement of grade 3 or higher peripheral neuropathy to grade 1.~Time to improvement was defined as the time from the first occurrence of grade 3 or higher treatment related neuropathy to improvement, as defined. Participants not experiencing improvement were censored at the last time the participant was evaluated for adverse events."|38 months|Treated population with ≥ grade 3 treatment-related peripheral neuropathy.||days||95% Confidence Interval|Median
131604|NCT00540514|Other Pre-specified|Maximal Degree of Thrombocytopenia Based on Clinical Laboratory Values of Platelet Count|The maximal degree of thrombocytopenia (and myelosuppression) was assessed by the overall nadir of platelet count based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.||× 10^9/L||Standard Deviation|Mean
131605|NCT00540514|Other Pre-specified|Maximal Degree of Neutropenia Based on Clinical Laboratory Values of Absolute Neutrophil Count|The maximal degree of neutropenia (and myelosuppression) was assessed by the overall nadir of absolute neutrophil count (ANC) based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.||× 10^9/L||Standard Deviation|Mean
131606|NCT00540514|Other Pre-specified|Maximal Degree of Anemia Based on Clinical Laboratory Values for Hemoglobin|The maximal degree of anemia (and myelosuppression) was assessed by the overall nadir of hemoglobin levels based on clinical laboratory measurements graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|38 months|Treated population where laboratory data were available.||g/L||Standard Deviation|Mean
131607|NCT00540514|Other Pre-specified|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment, by Histology|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.~A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.~Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesions).~Histology was determined at the time of primary diagnosis."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population. N indicates the number of participants in each histology category for each treatment arm respectively.||percentage of participants|||Number
131629|NCT00540436|Secondary|Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||mmHg||Standard Deviation|Mean
131608|NCT00540514|Secondary|SPARC Status and Correlation With Overall Survival|"The expression and cellular distribution of Secreted Protein Acidic and Rich in cysteine (SPARC) in biopsies of lung tumor was examined by immunohistochemistry using a 2 antibody system by an approved central laboratory and analyzed by 2 pathologists. The following tissue components were scored: tumor cells, fibroblasts, inflammatory cells, acellular stroma/matrix, and blood vessels.~To classify participants into high-SPARC and low-SPARC groups, an average z-score was calculated across variables and classified high-SPARC (average z-scores ≥0) and low-SPARC (average z-scores <0) groups.~SPARC status was then correlated with overall survival (the time from the day of randomization to participant death due to any cause)."|Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.|SPARC biomarker Population||participants|||Number
131609|NCT00540514|Secondary|Pharmacokinetic (PK) Parameters||Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.|Patients randomized to receive albumin-bound paclitaxel/carboplatin treatment in Canada, Russia, Ukraine and United States had the option to participate in sparse PK sampling in this study. Only 15 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed.|||||
131610|NCT00540514|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. Treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Up to 38 months|Treated population||participants|||Number
131611|NCT00540514|Secondary|Duration of Response in Responding Patients|Duration of response was assessed by progression free survival for participants who achieved a confirmed complete response or partial response based on blinded radiological assessment.|Assessed every 6 weeks, up to 38 months|Intent-to-treat patients with an objective response.||months||95% Confidence Interval|Median
131612|NCT00540514|Secondary|Percentage of Participants With Controlled Disease|Controlled disease was defined as the percentage of participants with stable disease for ≥ 16 weeks or confirmed complete or partial overall response, based on blinded radiological assessment. Stable disease was defined as neither sufficient shrinkage of target lesions to qualify for Partial Response, nor sufficient increase to qualify for Progressive Disease, or the persistence of one or more non-target lesions not qualifying for Complete Response or Progressive Disease.|Assessed every 6 weeks, up to 22 months|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
131613|NCT00540514|Secondary|Overall Participant Survival|Overall survival was defined as the time from the day of randomization to participant death (due to any cause), as assessed by post study follow-up performed monthly for 6 months and every 3 months thereafter for 12 months. All participants who were lost to the follow-up prior to the end of the trial or who completed the 18 month follow up phase were censored at last known time the participant was alive.|Up to 38 months|Intent-to-treat||months||95% Confidence Interval|Median
131614|NCT00540514|Secondary|Progression-free Survival by Blinded Radiology Assessment|"Progression free survival time was defined as the time from the day of randomization to the start of disease progression or death (any cause), whichever occurred first, based on the blinded radiological review response assessment. Progressive disease was defined as a ≥ 20% increase in the SLD of target lesions, taking as reference the nadir SLD recorded since the treatment started, or the presence of one or more new lesions, or the unequivocal progression of existing non-target lesion(s) or appearance of one or more new lesion(s).~Participants who did not have disease progression or had not died were censored at the last visit they were documented as progression free. If palliative radiotherapy or surgery at lesion sites occurred, the participant was censored at the last date without documented progression prior to radiotherapy or surgery. In follow-up, participants who began new therapy prior to progression were censored at the last documented date as progression-free."|Assessed every 6 weeks until progression or death, up to 38 months|Intent-to-treat||months||95% Confidence Interval|Median
131615|NCT00540514|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment|"Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response [CR] or Partial Response [PR]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0.~A complete response was defined as a disappearance of all target and non-target lesions and no new lesions.~Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the “unequivocal progression” of existing non-target lesion(s) or appearance of one or more new lesions)."|Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.|The intent-to-treat population which includes all randomized patients regardless of whether the patient received any study drug or had any efficacy assessments collected.||percentage of participants||95% Confidence Interval|Number
131630|NCT00540436|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or study discontinuation due to change to other PAH treatment. Time to clinical worsening is measured as the number of participants who experienced these events during 24 weeks.|Week 24|Full Analysis Set: : all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product||Participants|||Number
131792|NCT00536874|Secondary|Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy||Baseline and 2 years|||U/ml||Full Range|Median
131616|NCT00540449|Secondary|Number of Participants With Virologic Failure for the Resistance Determination by Emerging Resistance Associated Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as lack of virologic response (never having had 2 consecutive plasma viral load <50 copies/mL) and plasma viral load increase of >=0.5 log 10 copies/mL above nadir (i.e., never suppressed), or confirmed loss of virologic response (2 consecutive plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL; i.e., rebounder), or discontinued with a last observed on-treatment plasma viral load >=50 copies/mL after having had 2 consecutive plasma viral load <50 copies/mL. For this study, treatment-emergent reverse transcriptase (RT) resistance associated mutations (RAMs) occurring in at least 2 virologic failures (for at least one treatment group) for the following lists are presented: i) Extended list of Non-nucleoside reverse transcriptase inhibitor (NNRTI RAMs) ii) IAS-USA list of Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 96|"The ITT analysis set was considered the primary efficacy analysis set. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable (had data) for this outcome measure."||Participants|||Number
131617|NCT00540449|Secondary|Mean Change From Baseline to Week 48 and Week 96 in Absolute and Relative CD4+ Cell Counts (Using Imputed Data)|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline, Week 48, and Week 96|The ITT analysis set was considered the primary efficacy analysis set.||cells per microliter||Standard Deviation|Mean
131618|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
131619|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies/ml) at Week 48||Week 48|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
131620|NCT00540449|Secondary|Number of Participants With Virological Response (Observed, <50 Copies/ml) at Last On-Treatment Visit (Post-Week 96).|Virological response is defined as (observed) plasma viral load less than 50 human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) copies per ml at the last on-treatment visit (post-Week 96).|Variable, ranging from 3 months up to maximum 15 months for TMC278 and 12 months for Efavirenz after the 96-week visit|Participants with at least 1 Post-Week 96 visit were included in the analysis.||Participants|||Number
131621|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 96||Week 96|The Intent-to-Treat analysis set was considered the primary efficacy analysis set.||Participants|||Number
131622|NCT00540449|Secondary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 96||Week 96|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
131623|NCT00540449|Secondary|The Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies/ml) at Week 48|The analysis is based on the last observed viral load (VL) data within the Week 48 window. Virologic response is defined as a VL<50 copies/ml (observed case). Missing VL was considered as non-response. Virologic Failure includes subjects who had VL>=50 copies/ml in the Wk48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a VL>=50 copies/ml and subjects who had a switch in background regimen that was not permitted by the protocol.|Week 48|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
131624|NCT00540449|Primary|Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies/ml) at Week 48|Virological response is defined as confirmed plasma viral load less than (<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid [RNA]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load >= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load <50 copies/ml).|Week 48|The ITT analysis set was considered the primary efficacy analysis set.||Participants|||Number
131625|NCT00540436|Secondary|Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24|Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. BNP is a surrogate maker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||Nanograms/Liter (ng/L)||Standard Deviation|Mean
131626|NCT00540436|Secondary|Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24|PVR is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||mmHg/L/min||Standard Deviation|Mean
131627|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24|CO is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||L/min||Standard Deviation|Mean
131628|NCT00540436|Secondary|Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24|CI is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques).|Baseline and Weeks 12 and 24|Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study.||L/min/m2||Standard Deviation|Mean
131631|NCT00540436|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|There are four grades for WHO FC (class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Imputation technique was last observation carried forward.|Weeks 12 and 24|Full Analysis Set||Participants|||Number
131632|NCT00540436|Secondary|Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from baseline was calculated as the Week 12 and 24 values minus the baseline values. The BDI indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI scale was assessed by each participant. Imputation technique was last observation carried forward.|Baseline and Weeks 12 and 24|Full Analysis Set||Points on a scale||Standard Deviation|Mean
131633|NCT00540436|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal|Change from baseline was calculated as the Week 24/Withdrawal value minus the basline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. Imputation technique was last observation carried forward.|Baseline and Week 24/Withdrawal|Full Analysis Set||Meters||Standard Deviation|Median
131634|NCT00540436|Primary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12|Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.|Baseline and Week 12|Full Analysis Set (FAS): all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product. Imputation technique was last observation carried forward.||Meters||Standard Deviation|Mean
131635|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Vz/F|VZ/F: VZ is the volume of distribution based on the terminal phase, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||Liters||Standard Deviation|Mean
131636|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, CL/F|CL/F: CL is an estimate of the total body clearance, and F is the fraction of dose absorbed.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||L/hr (Liters/hour)||Standard Deviation|Mean
131637|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24|"AUC is area under a concentration vs. time curve.~AUC0-24 (Area under the plasma concentration-time curve between 0 to 24 hrs) is calculated using the following equation:~AUC0-24= AUClast + Clast × (1 - e-λz × [24-tlast])/λz. AUClast is AUC (area under a curve) computed to the last observation. Clast is concentration of last observation."|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||hr*ng/mL||Standard Deviation|Mean
131638|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Lambda z|Lambda z is first order rate constant associated with the terminal portion of the plasma concentration curve.|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||1/hour||Standard Deviation|Mean
131639|NCT00540423|Secondary|Pharmacokinetics of SB-497115, t1/2|t1/2 is half life based on the terminal phase|Week 9 or 10|PK Population. Data from one participant were abnormal; this participant was excluded from this analysis.||Hours||Standard Deviation|Mean
131640|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Tmax|tmax: Time when Cmax was achieved|Week 9 or 10|PK Population||Hours||Full Range|Median
131641|NCT00540423|Secondary|Pharmacokinetics of SB-497115-GR, Cmax|Cmax: Peak plasma concentration of SB-497115|Week 9 or 10|Pharmacokinetic (PK) Population: all participants with valid PK data following SB-497115-GR treatment||ng/mL (nanograms/milliliter)||Standard Deviation|Mean
131642|NCT00540423|Secondary|Mean Number of Days of Concomitant ITP Medication Use Per Month|Cumulative number of days for which a participant received ITP medication during the treatment/total treatment period (months). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Days||Standard Deviation|Mean
131643|NCT00540423|Secondary|Percentage of Participants Who Received Rescue Treatment for ITP|Rescue treatment for ITP is treatment applied to participants at high bleeding risk, such as those undergoing platelet transfusion or dose increase of steroids. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Percentage of participants|||Number
131644|NCT00540423|Secondary|Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline|ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline through Week 26|Full Analysis Set. Four participants in the Full Analysis Set did not have concomitant ITP medication at Baseline.||Percentage of participants|||Number
131645|NCT00540423|Secondary|Percentage of Participants With Bleeding Episode Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||Percentage of participants|||Number
131667|NCT00538642|Secondary|Triglycerides||Baseline|||mg/dL||Standard Deviation|Mean
131646|NCT00540423|Secondary|Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Total time is measured as the cumulative number of days over which platelet counts were maintained within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Days||Standard Deviation|Mean
131647|NCT00540423|Secondary|Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter|Maximum duration is measured as the longest period (days) for which a participant continuously maintained platelet counts within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Weeks 1 through 26|Full Analysis Set||Days||Standard Deviation|Mean
131648|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 and Weeks 10, 14, 18, 22, and 26 minus baseline value. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
131649|NCT00540423|Secondary|Mean Platelet Counts of Participants at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
131650|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26|Full Analysis Set||Percentage of responders|||Number
131651|NCT00540423|Secondary|Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||Participants|||Number
131652|NCT00540423|Secondary|Percentage of Participants With Bleeding Episodes Since the Last Visit|When abnormal bleeding(s) was found since the last visit, it was recorded as a bleeding episode(s).|Days 1, 8, 15, 22, 29, 36, and 43|Full Analysis Set||Percentage of participants|||Number
131653|NCT00540423|Secondary|Mean Change From Baseline in Platelet Counts at Each Visit|Change from baseline was calculated as values at Days 8, 15, 22, 29, 36, and 43 minus baseline value|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
131654|NCT00540423|Secondary|Mean Platelet Count at Each Visit|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|Baseline and Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||10^9/Liter||Standard Deviation|Mean
131655|NCT00540423|Secondary|Percentage of Responders at Each Visit|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Days 8, 15, 22, 29, 36, and 43|Full Analysis Set||Percentage of responders|||Number
131656|NCT00540423|Primary|Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.|Week 26|Full Analysis Set||percentage of participants|||Number
131657|NCT00540423|Secondary|Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter) at at least 4 out of 5 scheduled visits.|Weeks 2 through 6|Full Analysis Set||Participants|||Number
131658|NCT00540423|Primary|Number of Responders at Week 6|A responder was defined as a participant with a platelet count within the target range (>=50 x 10^9/Liter and <=400 x 10^9/Liter).|Week 6|Full Analysis Set: all randomized participants, with the exception of (1) those who did not receive any dose of study medication and (2) those with no valid platelet count measurements on therapy||Participants|||Number
131659|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|4-5 months|||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
131660|NCT00538642|Secondary|LDL Cholesterol||4-5 months|||mg/dL||Standard Deviation|Mean
131661|NCT00538642|Secondary|LDL Cholesterol||Baseline|||mg/dL||Standard Deviation|Mean
131662|NCT00538642|Secondary|HDL Cholesterol||4-5 months|||mg/dL||Standard Deviation|Mean
131663|NCT00538642|Secondary|HDL Cholesterol||Baseline|||mg/dL||Standard Deviation|Mean
131664|NCT00538642|Secondary|Cholesterol||4-5 months|||mg/dL||Standard Deviation|Mean
131665|NCT00538642|Secondary|Cholesterol||Baseline|||mg/dL||Standard Deviation|Mean
131666|NCT00538642|Secondary|Triglycerides||4-5 months|||mg/dL||Standard Deviation|Mean
131677|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131678|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131679|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131680|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia and who had received at least 1 dose of study medication.||Participants|||Number
131681|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131682|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131683|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131684|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131685|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131686|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131687|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131688|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131689|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131690|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131691|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131692|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131693|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131694|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131695|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131696|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131697|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication||Participants|||Number
131698|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131699|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131700|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131701|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131702|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131703|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication||Participants|||Number
131704|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.||Participants|||Number
131705|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.||Participants|||Number
131706|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.||Participants|||Number
131707|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131708|NCT00538629|Primary|Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?|MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.|Baseline and final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131709|NCT00538629|Primary|Global Efficacy Evaluation Scores (Schizophrenia Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.||Participants|||Number
131710|NCT00538629|Primary|Global Efficacy Evaluation Scores (Bipolar Population)|The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131711|NCT00538629|Primary|Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit|EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline and final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
131712|NCT00538629|Primary|Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline|BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.|Baseline to final visit (week 12)|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
131713|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The schizophrenia full analysis set included all subjects who had been diagnosed with schizophrenia and had received at least 1 dose of study medication.||Participants|||Number
131714|NCT00538629|Primary|Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)|CGI-C assesses change in severity of the condition using a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.|Final visit (week 12)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131715|NCT00538629|Primary|Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline|MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
131716|NCT00538629|Primary|Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline|The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline.|Baseline to final visit (12 weeks)|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If the final visit measurement was missing, the follow-up measurement could be carried forward. If any individual item was missing, the total score was set to missing.||Score on scale||Standard Deviation|Mean
131717|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication||Participants|||Number
132036|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Weight||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||kilograms||Standard Error|Least Squares Mean
131718|NCT00538629|Primary|Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)|CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.|Baseline|The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.||Participants|||Number
131719|NCT00538616|Primary|Lactate/Pyruvate (L/P)Ratio|L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.|1 hour|||ratio||Standard Deviation|Mean
131720|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|30 days|||mm Hg||Standard Deviation|Mean
131721|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|90 days|||mm Hg||Standard Deviation|Mean
131722|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|180 days|||mm Hg||Standard Deviation|Mean
131723|NCT00538590|Secondary|Complications|Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.|360 days|||percentage of participants||Standard Deviation|Mean
131724|NCT00538590|Primary|Postoperative Intraocular Pressure Change|Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.|360 days|||mm Hg||Standard Deviation|Mean
131725|NCT00540293|Secondary|Percent Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Percent changes from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).||percent||95% Confidence Interval|Median
131726|NCT00540293|Secondary|Changes From Baseline in Selected Inflammatory Markers After 8 Weeks of Treatment.|Median baseline, and change from baseline in monocyte chemoattractant protein (MCP-1), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) by risk group - FAS|Baseline, and 8 weeks|Laboratory Population: 17 subjects from FAS (n=425) were not included in Laboratory Population (n=408).||pg/dL||95% Confidence Interval|Median
131727|NCT00540293|Secondary|Percent Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Percent change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||percentage||95% Confidence Interval|Median
131728|NCT00540293|Primary|Percent of Subjects in the Total and Each Cardiovascular Risk Group Achieving Low Density Lipoprotein-cholesterol (LDL-C) Target After 8 Weeks of Treatment.|LDL-C Responders by visit and by risk group - full analysis set (FAS)|Week 8|N=number of subjects in the Full Analysis Set (FAS). Number of Participants Analyzed represents subjects with on-treatment lipid measures (missing values imputed by last observation carried forward)||Percentage of participants||95% Confidence Interval|Mean
131729|NCT00540293|Secondary|Change From Baseline in High Sensitive Circulating C-reactive Protein (Hs-CRP) After 4 and 8 Weeks of Treatment|Median baseline, and change from baseline in hs-CRP by risk group - FAS|4 and 8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||mg/dL||95% Confidence Interval|Median
131730|NCT00540293|Secondary|Percent of Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficay evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||percentage of participants||95% Confidence Interval|Mean
131731|NCT00540293|Secondary|Subjects Who Achieved LDL-C Target With no Titration of Atorvastatin and After One Step Titration of Atorvastatin.|LDL-C responders at week 8 by titration status and risk groups - FAS, efficacy evaluation (EVAL), and FAS (no last observation carried forward, LOCF)|8 weeks|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||Participants|||Number
131732|NCT00540293|Secondary|Percent Changes From Baseline in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean percent changes from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|weeks 4 and 8|Laboratory Population: 10 subjects from FAS (n=425) were not included in Laboratory Population (n=415).||Percent||95% Confidence Interval|Mean
131733|NCT00540293|Secondary|Changes in Lipid Parameters in Subjects in the Total Group and Each Cardiovascular Risk Group After 4 and 8 Weeks of Treatment|Mean baseline, change and percent change from baseline in lipid parameters by risk group - FAS. HDL-C: high density lipoprotein-cholesterol; TC: total cholesterol; TG: triglyceride|Weeks 4 and 8|||mg/dL (ratio for Scalar)||95% Confidence Interval|Mean
131734|NCT00540293|Secondary|Percent of Subjects in the Total Group and Each Cardiovascular Risk Group Achieving LDL-C Target After 4 Weeks of Treatment.|LDL-C Responders by visit and by risk group - FAS|Week 4|||Percent subjects achieved LDL-C target||95% Confidence Interval|Mean
131735|NCT00540228|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
132037|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pulse Rate||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||beats per minute||Standard Error|Least Squares Mean
131736|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
131737|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination|From Day 0 to Day 180|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
131738|NCT00540228|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature above (>) 38.0 degrees Celsius (°C)], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
131739|NCT00540228|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
131740|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||cells||Standard Deviation|Mean
131741|NCT00540228|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-γ), at least IL2 and at least TNF alpha (TNF-α).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||cells||Standard Deviation|Mean
131742|NCT00540228|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 4 influenza strains assessed were A/Wisconsin (WISC), B/Malaysia (MALA), A/Brisbane (BRIS) and B/Florida (FLOR). The seropositivity cut-off assay was 1:28.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
131743|NCT00540228|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
131744|NCT00540228|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
131745|NCT00540228|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA).|At Days 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
131770|NCT00539994|Primary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Day 12 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on day 12 are negative and have been eradicated of S. Aureus.|Day 12|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2 and 3.||Percentage of participants|||Number
131746|NCT00540228|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.|At Days 0, 21 and 180|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
131747|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp)|Vcomp, defined as the volume of voided urine (measured in milliliters [mL]).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||milliliters||Standard Deviation|Mean
131748|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean)|Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||milliliters per second||Standard Deviation|Mean
131749|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary|A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination).|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||average number per week||Standard Deviation|Mean
131750|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary|A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||average number per week||Standard Deviation|Mean
131751|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary|Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||average number per week||Standard Deviation|Mean
131752|NCT00540124|Secondary|Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies|"Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||participants|||Number
131753|NCT00540124|Secondary|Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were worse (scores of 5, 6, or 7), no change (score of 4), or better (scores of 1, 2, or 3)."|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||participants|||Number
131754|NCT00540124|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II)|The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit.|baseline, 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
131755|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore|IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia).|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
131756|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore|The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
131789|NCT00536913|Primary|Urinary Free Cortisol (UFC)|Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment|At baseline and 4 weeks|||Ratio||Full Range|Geometric Mean
131757|NCT00540124|Secondary|Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore|The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation.|baseline, 4, 8, and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
131758|NCT00540124|Secondary|Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 4 and 8 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
131759|NCT00540124|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|baseline, 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
131760|NCT00540046|Secondary|Expulsion|IUD was not removed by provider but fell out on its own.|6 months|The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD.||percentage of expulsions|||Number
131761|NCT00540046|Primary|Use of IUD|Number of participants using Copper T380A IUD 6 months after surgery|6 months|||participants|||Number
131762|NCT00539994|Other Pre-specified|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|All subjects were positive (pos.) for S. Aureus in the Pharyngeal region on days 12 or 33 (D12 and D33) and Negative (neg.) in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33.|Per Protocol Population: Persistant Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and those who were Positive for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.||Percentage of participants|||Number
131763|NCT00539994|Secondary|Number of Participants With a Nasal Culture Negative for MRSA (Methicillin-resistant S. Aureus)|The number of participants who tested negative for MRSA on days 7, 12, and 33.|Days 7, 12, or 33.|Screening Eligibility Population: only participants who provided nasal cultures at Days 7, 12, and 33 were analyzed.||participants|||Number
131764|NCT00539994|Secondary|Prevalence of S. Aureus Nasal and Pharyngeal Carriage by Visit.|All participants were assessed for nasal and pharyngeal carriage at Screening Visits 1, 2, and 3. Participants were randomized into the study only if they had positive cultures at screening visit 1 and screening visit 2 and/or screening visit 3. Day 1 data were collected only for those participants who were randomized into the study.|Screening Visits 1 (Day -42 to Day -14), 2 (Day -11 to Day -4), and 3 (Day -11 to Day -4) and Day 1|Screening Population (participants who had anterior nares swab obtained for S. aureus culture) was analyzed for Screening Visit (SV) 1. Only subjects who had positive cultures for S. aureus at SV 1 were allowed to continue to SV 2 and 3. The Safety Population (participants who received at least one dose of study drug) was analyzed at Day 1.||participants|||Number
131765|NCT00539994|Secondary|Percentage of Participants With Nasal Recolonization With S. Aureus on Study Days 12 and 33 Who Were Persistant Carriers Who Tested Positive in the Pharyngeal Region on Days 12 and 33 But Negative in the Nasal Region on Day 7 or Days 7 and 12|Percentage of subjects that were recolonized on Day 12 (D12) and Day 33 (D33) that were negative (neg.) for S. Aureus in the Pharyngeal region on days 12 or 33 and Negative in the Nasal Region on day 7 (D7) or days 7 and 12. Pharyngeal culture, PC; nasal culture, NC.|Days 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3 and those who were NEGATIVE for Pharynegeal Carriage on Day 12 and Day 33 then recolonized.||Percentage of participants|||Number
131766|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Each Post Treatment Visit Stratified by Pharyngeal Carriage Status|Comparison of nasal S. aureus eradication in persistent carrier subjects on 7, 12, and 33 days after treatment stratified by S. aureus carriage in the pharyngeal area|Days 1, 7, 12, and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visit 1, 2, 3, and who were Persistent Nasal carriers who were both positive and negative carriers of S. aureus in the Pharyngeal region.||Percentage of participants|||Number
131767|NCT00539994|Secondary|Percentage of Participants With Eradication of S. Aureus Nasal Carriage at Days 7 and 33 Who Were Categorized as Persistent Carriers of S. Aureus|Subjects who tested positive as persistent carriers of S. Aureus who on Days 7 and 33 are negative and have eradicated of S. aureus.|Days 7 and 33|Per Protocol Population: Persistent Carriers of the Intent-to-Treat (ITT) Population who Tested Positive on Screening Visits 1, 2 and 3.||Percentage of participants|||Number
131768|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Day 5|Per Protocol Population of Intent-to-treat||hours||Standard Deviation|Mean
131769|NCT00539994|Secondary|Plasma Retapumulin Pharmacokinetic Parameters, Tmax, by Treatment at Days 1 and 3|Tmax - The time after administration of a drug when the maximum plasma concentration is reached, when the rate of absorption equals the rate of elimination.|Days 1 and 3|Per Protocol Population of Intent-to-treat||hours||Standard Deviation|Mean
131771|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and high value was 2.74 ng/mL|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling||ng/mL||Standard Deviation|Mean
131772|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma Cmax After Dosing|Cmax is the peak serum concentration. Low value was not calculable, and High value was 2.74 ng/mL.|Days 1 and 3|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling||ng/mL||Standard Deviation|Mean
131773|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Day 5 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Day 5|Pharmacokinetic Concentration Population - included all subjects who underwent plasma PK sampling||ng.h/mL||Standard Deviation|Mean
131774|NCT00539994|Primary|Plasma Retapumulin Pharmacokinetic Parameters by Treatment at Days 1 and 3 Evaluated by Plasma AUC After Dosing|Area under the plasma concentration curve (AUC) is used to calculate drug clearance and bioavailability using plasma concentration and time curve.|Days 1 and 3|Pharmacokinetic (PK) Concentration Population - included all subjects who underwent plasma PK sampling||ng.h /mL||Standard Deviation|Mean
131775|NCT00539942|Secondary|Incidence of Untoward Effects With Arixtra|Adverse events will be evaluated to determine untoward effects.|21 days|Unable to analyze data.||participants|||Number
131776|NCT00539942|Primary|Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra|Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.|21 days|Planned Intention to Treat analysis but was unable to complete due to inadequate number of subjects enrolled.||participants|||Number
131777|NCT00539864|Secondary|Percentage of Participants With Seroprotection|Percentage of participants with (HAI titer greater than or equal to 40) at Day 28|Day 28 following immunization at Day 0|||Percentage of participants||95% Confidence Interval|Number
131778|NCT00539864|Secondary|Percentage of Participants With Seroconversion|Percentage of participants with greater than or equal to a 4-fold rise in Hemagglutination-Inhibition Assay (HAI) titer over Day 0 at Day 28 following immunization|Day 28 following immunization at Day 0|All randomized subjects who received study vaccine and who had day 0 and day 28 HAI titers||Percentage of participants|Participants|95% Confidence Interval|Number
131779|NCT00539864|Primary|Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)|Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.|Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization|Safety population included all randomized subjects who received a dose of study vaccine.||participants|||Number
131780|NCT00539864|Secondary|Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.|Immunogenicity was assessed by measuring the difference in values in Hemagglutination-Inhibition Assay (HAI) titers in participants from Day 0 to Day 28, using Geometric Mean Titers (GMTs). The GMTs from the FluBlok and TIV groups were then compared.|Day 0 and Day 28|All randomized subjects who received study vaccine and had Day 0 and Day 28 HAI titers||HAI Titers||95% Confidence Interval|Geometric Mean
131781|NCT00536913|Secondary|Use of Rescue Medication at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Inhalations||Standard Deviation|Mean
131782|NCT00536913|Secondary|Use of Rescue Medication at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Inhalations||Standard Deviation|Mean
131783|NCT00536913|Secondary|Percentage of Nights With Awakenings Due to Asthma|Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Percentage of nights||Standard Deviation|Mean
131784|NCT00536913|Secondary|Asthma Symptoms at Day|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks|||Units on a scale||Standard Deviation|Mean
131785|NCT00536913|Secondary|Asthma Symptoms at Night|Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Daily during run-in and daily during treatment period of 6 weeks|||Units on a scale||Standard Deviation|Mean
131786|NCT00536913|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Liters/min||Standard Deviation|Mean
131787|NCT00536913|Secondary|Morning Peak Expiratory Flow (mPEF)|Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.|Daily during run-in and daily during treatment period of 6 weeks|||Liters/min||Standard Deviation|Mean
131788|NCT00536913|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.|At baseline, at 2 weeks and 4 weeks|||Liters||Full Range|Mean
131793|NCT00536874|Secondary|RECIST Radiologic Response to Neoadjuvant Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|2 years|||participants|||Number
131794|NCT00536874|Secondary|Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy||Baseline and 2 years|||ng/ml||Full Range|Median
131795|NCT00536874|Secondary|Overall Survival (Follow-Up Time)||From Baseline until 2 Years and Follow-Up, up to 120 months|||months||Full Range|Median
131796|NCT00536874|Primary|Overall Survival at 18 Months|Percentage of participants that were alive or survived at 18 months after randomization|18 months|||percentage of participants||95% Confidence Interval|Number
131797|NCT00539734|Primary|Time to Response (Implicit Time) of Multifocal ERG Signal|Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.|baseline, 3 months|||millisecond|Participants|Standard Deviation|Mean
131798|NCT00539734|Secondary|Postoperative Complication|For instance, Endophthalmitis, retinal detachment|1 month||||||
131799|NCT00539734|Primary|Height (Amplitude) of Multifocal ERG Signal|Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.|baseline, 3 months|Analysis was per protocol||nanovolt/degree^2|Participants|Standard Deviation|Mean
131800|NCT00539695|Other Pre-specified|Ancillary Studies|"To conduct ancillary studies on those patients to investigate before, during and after IL-2 administration to determine:~The immunophenotype of PBMCs~The suppressive activity of CD4+ CD25+ FoxP3+ Tregs~Cytokines secreted by PBMCs~NK cell analysis"|12 weeks||||||
131801|NCT00539695|Secondary|Immunomodulatory Effects of IL-2 Administered After Allogeneic Hematopoietic Stem Cell Transplantation Will be Evaluated by Descriptive Statistics.||12 weeks||||||
131802|NCT00539695|Secondary|Rate of Severe (Grade III or IV) Acute GVHD|To determine the efficacy of low-dose IL-2 in the prevention of severe (grade III or IV) acute GVHD|12 weeks||||||
131803|NCT00539695|Primary|Rate of Dose Limiting Toxicities|Assessment of the safety and the toxicity of low-dose IL-2, administered according to the dosage described in this protocol, in this group of patients The outcome measure is the proportion of participants with dose limiting toxicities.|6-12 weeks|||proportion of participants of DLT||95% Confidence Interval|Number
131804|NCT00539617|Secondary|To Determine the Effects of Erlotinib on EGFR Signaling and Tumor Cell Survival in Esophageal Cancer.||2 years||||||
131805|NCT00539617|Secondary|To Estimate the Correlation of Epidermal Growth Factor Receptor (EGFR) Gene Amplification and EGFR Gene Expression Levels in Esophageal Cancer.||2 years||||||
131806|NCT00539617|Secondary|To Determine Toxicity and Tolerability of the Erlotinib and FOLFOX Treatment Regimen in the Selected Patient Population.||2 years||||||
131807|NCT00539617|Secondary|To Determine the Time to Progression in This Population After Initiation of Erlotinib Alone, Following Erlotinib and FOLFOX Combination Chemotherapy.||2 years||||||
131808|NCT00539617|Secondary|Response Rate (RR)|To determine the number of participants with partial response (PR) or stable disease (SD) for the objective tumor response rate in the selected patient population treated with erlotinib and FOLFOX.|2 years|Only 4 patients were eligible and started the the Run-In Phase on treatment.||participants|||Number
131809|NCT00539617|Primary|Progression Free Survival (PFS)|To determine the number of participants with progression free survival after 6 months form the first day of the Erlotinib Run-In Phase for patients treated on study.|2 years|Only 4 patients were eligible and started the Run-In Phase on treatment.||participants|||Number
131810|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum B)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.|||||
131811|NCT00539591|Other Pre-specified|BRIEF Psychological Assessment (Stratum A)|The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.||T score||Standard Deviation|Mean
131812|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum B)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.|||||
131813|NCT00539591|Other Pre-specified|BASC-2 Psychological Assessment (Stratum A)|The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.|Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy|This QOL analysis included patients only within Stratum A.||T score||Standard Deviation|Mean
131814|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.||units on a scale|||Number
131863|NCT00539240|Secondary|Health Related Quality of Life|SF-36 Physical Component Score (higher number better quality of life), is a measure of overall physical quality of life distinct from mental health. The range is 0 - 100. It has been adjusted to US national norms so that a score of 50 corresponds to the national mean.|end of study|ITT||units on a scale||Standard Deviation|Mean
131815|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
131816|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.||units on a scale|||Number
131817|NCT00539591|Other Pre-specified|Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.|Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
131818|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.||units on a scale|||Number
131819|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
131820|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum B)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.||units on a scale|||Number
131821|NCT00539591|Other Pre-specified|Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum A)|QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.|Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post|This QOL analysis included patients only within Stratum A.||units on a scale||Standard Deviation|Mean
131822|NCT00539591|Other Pre-specified|Systemic Clearance (CL) of Interferon ɑ-2B|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||l/hr/m^2||Full Range|Median
131823|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||l/m^2||Full Range|Median
131824|NCT00539591|Other Pre-specified|Half-Life of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||hours||Full Range|Median
131825|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Interferon ɑ-2b|Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 to infinity.|Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion|The pharmacokinetic(PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.||pcg * hr/ml||Full Range|Median
131860|NCT00539279|Primary|PTSD Checklist (PCL)|The PTSD Checklist is a self-report questionnaire about PTSD symptoms. The version used in this study is called the PCL-S, which denotes a specific traumatic event for subjects to respond to. There are 17 items, each with response categories from 1 to 5. Thus, the total score ranges from 17 to 85. Higher scores reflect higher levels of PTSD symptoms, and a score of 50 or above is commonly interpreted to designate clinically significant PTSD symptoms.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Median
131826|NCT00539591|Other Pre-specified|Apparent Clearance (CL) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis due to differences in clinical variables, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||ml/hr/kg||Full Range|Median
131827|NCT00539591|Other Pre-specified|Volume of Central Compartment (Vc) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling due to differences in clinical variables. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||ml/kg||Full Range|Median
131828|NCT00539591|Other Pre-specified|ɑ Half Life of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||hours||Full Range|Median
131829|NCT00539591|Other Pre-specified|Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B|"Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 through infinity."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.||pcg * hr/ml||Full Range|Median
131830|NCT00539591|Other Pre-specified|Median Steady State Trough Concentration of Pegylated Interferon ɑ-2B|"The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed.~Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM."|Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28|Only one patient had evaluable data in Stratum B and is not included in the final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling.||pcg/ml||Full Range|Median
131831|NCT00539591|Primary|Probability of Event-free Survival (EFS) of Stratum A Participants|The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method.|3 years from diagnosis|||probability||95% Confidence Interval|Number
131832|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients|"The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants.~Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:~Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy~Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)~Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy~Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy~Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|Number of participants for the analysis was based on the intent to treat population, all patients enrolled were included. Participants were enrolled on Stratum A until the accrual goals were met on Stratum B.||participants|||Number
131833|NCT00539591|Primary|Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2|"The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants.~Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:~Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy~Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)~Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy~Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy~Grade 4 mood alteration (suicidal ideation; danger to self or others)"|52 weeks|This toxicity report was based on intention to treat population (ITT), all patients enrolled were included. The study did not meet its accrual goals within the planned timeframe due to slow accrual.||participants|||Number
131861|NCT00539240|Primary|Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for acid regurgitation during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT||days||Standard Deviation|Mean
131834|NCT00539591|Primary|Tumor Response Rate|Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment.|8 weeks|||participants|||Number
131835|NCT00539539|Secondary|Ventilation Rate|Average ventilation rate (breaths/minute) during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Ventilation rate available in 347 participants on the feedback on arm and 346 on the feedback off arm.||breaths per minute||Standard Error|Mean
131836|NCT00539539|Secondary|Percentage of Compressions With an Incomplete Release|Percentage of compressions with incomplete release during the first ten minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Incomplete release available for 529 participants on the feedback on arm and 467 on the feedback off arm.||% of compressions w/ incomplete release||Standard Error|Mean
131837|NCT00539539|Secondary|Compression Rate|Average compression rate during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Average compression rate available for 604 participants on the feedback on arm and 570 on the feedback off arm.||Compressions per minute||Standard Error|Mean
131838|NCT00539539|Secondary|Compression Depth|Average compression depth (mm) during the first 10 minutes of CPR.|Up to 10 minutes of CPR|Intention to treat. Compression depth available for 529 participants on the feedback on arm and 467 on the feedback off arm.||mm||Standard Error|Mean
131839|NCT00539539|Secondary|CPR Fraction|Percentage of time during CPR spend doing compressions.|Up to 10 minutes of CPR|Intention to treat, with CPR fraction available for 604 participants on the feedback on arm, and 570 on the feedback off arm.||Percentage||Standard Error|Mean
131840|NCT00539539|Secondary|Survival to Hospital Discharge|Survival to hospital discharge|Length of Hospitalization|Intention to treat, with survival to hospital discharge missing for one participant on the feedback off arm. Analysis included 815 participants on the feedback on arm, and 770 on the feedback off arm.||Participants|||Number
131841|NCT00539539|Secondary|Pulses Present at ED Arrival.||Resuscitation|Intention to treat. Presence of pulses not known for one participant on the feedback off arm. Analysis includes 815 participants on the feedback on arm and 770 on the feedback off arm.||Participants|||Number
131842|NCT00539539|Primary|Rate of ROSC During the Prehospital Resuscitation|Return of spontaneous circulation (ROSC)|Prehospital resuscitation|Intent to treat||Participants|||Number
131843|NCT00539526|Secondary|Change From Baseline in Tear Break-Up Time (TBUT) at Month 3|Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Month 3|||Seconds||Standard Error|Mean
131844|NCT00539526|Secondary|Change From Baseline in Corneal Staining With Fluorescein at Month 3|Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.|Baseline, Month 3|||Scores on a Scale||Standard Error|Mean
131845|NCT00539526|Primary|Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3|Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.|Baseline, Month 3|||Scores on Scale||Standard Error|Mean
131846|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at 12 Weeks|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression"|12 weeks|Participants that completed the study were analyzed||units on a scale||Standard Deviation|Mean
131847|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at 12 Weeks|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive-compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|12 Weeks|Participants who completed the intervention were included in the analysis||units on a scale||Standard Deviation|Mean
131862|NCT00539240|Primary|Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline|the number of days with Symptom Intensity Score < 3 (better) for nighttime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|ITT||days||Standard Deviation|Mean
131848|NCT00539513|Secondary|The Hamilton Depression Inventory (HAM-D)at Baseline|"The Hamilton Rating Scale for Depression is a multiple item (traditionally 17) assessment used to provide an indication of depression and as a guide to evaluate recovery. The clinician-rated assessment is designed for adults and is used to rate the severity of patient depression by asking about mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient’s level of retardation, and insight into their depression.~In this study, the HAM-D17 (17 items scored) was used to obtain depression severity ratings with a maximum possible score of 52. Baseline ratings are compared to those of week 12 to produce a percentage of change, where positive values indicate a decrease in depressive severity/symptoms. Maximum score is a 52.~Ranges~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥23 = Very Severe Depression"|Baseline|Participants that completed the study were analyzed||units on a scale||Standard Deviation|Mean
131849|NCT00539513|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at Baseline|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of obsessive–compulsive disorder without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions.~Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0–7 = sub-clinical 8–15 = mild 16–23 = moderate 24–31 = severe 32–40 = extreme~In this study, baseline ratings are compared to those of week 12 to produce a percent of change with positive percentages indicating a decrease in symptom severity."|Baseline|Participants who completed the intervention were included in the analysis||units on a scale||Standard Deviation|Mean
131850|NCT00539305|Primary|Short-Form Health Survey (SF-36)|Self assessment of Physical Functioning in Health Survey. Higher scores indicate a higher level of functioning (range 0-100). Month 3 and 6 values represent change from baseline in subscale.|Baseline, Month 3, Month 6|||units on a scale||Standard Deviation|Mean
131851|NCT00539305|Primary|Geriatric Depression Scale (GDS)|Values represent self evaluation of depression (range 0-30). Higher scores indicate a more depressed mood. Month 3 and Month 6 indicate change from baseline.|Baseline, Month 3, Month 6|||units on a scale||Standard Deviation|Mean
131852|NCT00539305|Primary|Cognitive Changes Measured by Neuropsychological Tests: Rey Auditory Verbal Learning Test|Values represent total score in Long Delay Word List Recall. Higher score indicates higher level of functioning (range 0-15). Month 3 and Month 6 indicate change from baseline.|Baseline, 3 and 6 months|||units on a scale||Standard Deviation|Mean
131853|NCT00539305|Primary|Behavioral & Mood Measure: Profile of Mood States (POMS)|Values represent self evaluation of vigor-activity. The scale compares t-scores of participants to published norms (range 0-100), and higher scores indicate elevated emotion in subscale. Higher t-scores in vigor-activity subscale are considered favorable. Month 3 and Month 6 values display change from baseline.|Baseline, 3 and 6 months|Vigor-Activity||units on a scale||Standard Deviation|Mean
131854|NCT00539279|Primary|Clinician-Administered PTSD Scale Severity Score (CAPS)|The CAPS is a clinician-administered interview about PTSD symptoms. There are 17 scored items for PTSD severity, each with response categories from 0 (zero) to 4 separately for both frequency and severity. Thus, each item can receive a score of 0 (zero) to 8, and the total severity score ranges from 0 to 136. Higher scores reflect higher levels of PTSD symptoms. Scores of 60 or above are generally considered clinically significant, and changes of 10 points or more (e.g., between pre-treatment and post-treatment) are considered clinically significant changes.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
131855|NCT00539279|Secondary|Global Neuropsychological Deficits (Standardized, Composite)|Among our battery of seven neuropsychological tests, we worked with our neuropsychologist to choose 13 key scales. We used a conversion system to equally weight areas where there were large deficits, even if there were only one or two deficits, to prevent such scores from being minimized among the large range of T scores for the other scales. We converted T scores as follows: >40 = 0; 35-39 = 1; 30-34 = 2; 25-29 = 3; 20-24 = 4; < 20 = 5. Higher scores mean a higher global cognitive deficit.|Pre-treatment, post-treatment|||standardized units on a scale||Standard Deviation|Mean
131856|NCT00539279|Secondary|Sheehan Disability Scale (SDS)|The SDS is a self-report questionnaire about functioning. There are 3 scored items (Work/School; Social Life; and Family Life/Home Responsibilities), each with response categories from 0 (zero; Not at All) to 10 (Extremely). Thus, the total score ranges from 0 to 30. Higher scores reflect lower (poorer) levels of functioning.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
131857|NCT00539279|Primary|Patient Health Questionnaire Depression Subscale (PHQ-9)|"The PHQ-9 is a self-report questionnaire about depressive symptoms. There are 9 scored items, each with response categories from 0 (zero) to 3. Thus, the total score ranges from 0 to 27. Higher scores reflect higher levels of depressive symptoms, with interpretation as follows:~0 (zero) No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression"|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
131858|NCT00539279|Secondary|State-Trait Anxiety Inventory State Scale (STAI-S)|"The STAI-S is a self-report questionnaire about state (present state) anxiety. There are 20 scored items, each with response categories from 1 (Not at All) to 4 (Very Much So). Some items (e.g., I feel calm) are reversed scored so that the total score appropriately reflects state anxiety. Thus, the total score ranges from 20 to 80. Higher scores reflect higher levels of state anxiety."|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
131859|NCT00539279|Secondary|Posttraumatic Cognitions Inventory (PTCI)|The PTCI is a self-report questionnaire about thoughts following traumatic events. There are 33 scored items, each with response categories from 1 (Totally Disagree) to 7 (Totally Agree), summed to create the total score. Thus, the total score ranges from 7 to 231. Higher scores reflect higher levels of negative cognitions.|Pre-treatment, post-treatment, and 6-month follow-up|||units on a scale||Standard Deviation|Mean
131864|NCT00539240|Primary|Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)|the number of days with Symptom Intensity Score < 3 (better) for daytime heartburn during week 6 as compared to baseline|Symptom control after 6 weeks of treatment|intention to treat (ITT)||days||Standard Deviation|Mean
131865|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at Baseline|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient's level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|Baseline|||units on a scale|||Number
131866|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at Baseline|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever intentionally, or on purpose tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|Baseline|||units on a scale|||Number
131867|NCT00539188|Secondary|Hamilton Depression Rating Scale (HAM-D) at 6 Weeks|"The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Administered by a clinician, The questionnaire is designed for adults and is used to rate the severity of the patients depression by asking their mood, feelings of guilt, insomnia, agitation, weight change, suicidal ideation, and somatic symptoms. The scale also allows the clinician to assess the patient’s level of retardation, and insight into their depression. Highest possible score is 52.~HAM-D Scoring 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severed Depression~≥23 = Very Severe Depression~In this study, Baseline ratings were compared to those of week 6 to assess each participants change in depression throughout the study. A negative value indicates an increase in depression (i.e. the individual felt more depressed) and a positive value indicates a decrease in depression."|6 weeks|||units on a scale|||Number
131868|NCT00539188|Primary|Self-Harm Inventory (SHI) Score at 6 Weeks|"The Self-Harm Inventory is assessed by asking an individual to answer (yes or no) if they have ever “intentionally, or on purpose” tried to harm themselves. The inventory contains 22 questions and a 23rd marked other that allows the individual to indicate a self-harm behavior not previously mentioned.~The scoring of this instrument is determined by counting the number of endorsed self-harm behaviors out of the possible twenty-three asked. The maximum score any individual may achieve for the SHI is a 23. Any individual scoring 5 or greater is classified as suffering from BPD.~In this study, scoring on the SHI was primarily used to assess improvement of self-harming symptoms and throughout the study by comparing participant ratings from baseline and week 6. Positive numbers indicate a decrease (i.e. participant indicated less self-harming behavior) and negative numbers indicate an increase in self-harming behaviors reported."|6 weeks|||units on a scale|||Number
131869|NCT00539110|Secondary|Pharmacokinetics|evaluate the PK of zolpidem following standard dosing practices|2 weeks postburn||||||
131870|NCT00539110|Primary|Polysomnography Data|Determine if intervention product elicits more total sleep time|2 weeks postburn|||minutes||Standard Error|Mean
131871|NCT00539032|Primary|Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.||Day 28 Post-vaccination|4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.||Percentage of Participants|||Number
131872|NCT00539032|Primary|Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.||Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination|Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
131873|NCT00539032|Other Pre-specified|Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®|Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.||Participants|||Number
131874|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
131875|NCT00539006|Secondary|Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
131907|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2|30 days post-dose 2|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
131876|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist|Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
131877|NCT00539006|Primary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Participants assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Participants|||Number
131878|NCT00539006|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
131879|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use|"Participants assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
131880|NCT00539006|Secondary|Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat|"Participants assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Participant could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
131881|NCT00538915|Primary|To Assess the Efficacy of Nabi-IGIV 10% in Preventing Serious Bacterial Infections (SBIs) Compared to Historical Control Data [Per US Food and Drug Administration (FDA) Requirements by Demonstration of a Serious Infection Rate Per Person Year of <1.0].|The primary efficacy parameter was the serious bacterial infections (SBIs) rate per person-years compared to historical control data [as determined by requirements established by the US Food and Drug Administration (FDA) by demonstration of a serious infection rate per person year of <1.0]. The infections included bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.|One year|63 subjects enrolled, received treatment and included in the Safety population. 5 subjects excluded from the Intent To Treat (ITT) population due to significant, excessive protocol violations and an insufficient number of infusions to elicit the intended effect. Resulted in a total of 58 (92.1%) subjects in the Intent To Treat (ITT) population.||SBIs Per Total Person-Years|||Number
131882|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||score on a scale||Standard Deviation|Mean
131883|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||score on a scale||Standard Deviation|Mean
131908|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1|30 days post-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
131884|NCT00538902|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period|SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Double-Blind portion of the study), Observed cases included.||score on a scale||Standard Deviation|Mean
131885|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||score on a scale||Standard Deviation|Mean
131886|NCT00538902|Secondary|Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period|HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).||score on a scale||Standard Deviation|Mean
131887|NCT00538902|Secondary|Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||mm||Standard Deviation|Mean
131888|NCT00538902|Secondary|Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||mm||Standard Deviation|Mean
131889|NCT00538902|Secondary|Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||mm||Standard Deviation|Mean
131890|NCT00538902|Secondary|Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period|Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.|Baseline, Week 12|Intent-to-Treat (ITT) population (all subjects who received at least 1 dose of study drug during the double-blind period), Last Observation Carried Forward (LOCF).||mm||Standard Deviation|Mean
131909|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at Pre-dose 1|Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1|Pre-dose 1|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
131891|NCT00538902|Secondary|Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Joints||Standard Deviation|Mean
131892|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Joints||Standard Deviation|Mean
131893|NCT00538902|Secondary|Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period|"Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present (1), absent (0), replaced (9), or no assessment (NA). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period."|Baseline, Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).||Joints||Standard Deviation|Mean
131894|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Participants|||Number
131895|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Participants|||Number
131896|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period|American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.||Participants|||Number
131897|NCT00538902|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.|Week 12|Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), non-responder imputation (NRI; missing ACR responses imputed as non-responders).||Participants|||Number
131910|NCT00538785|Secondary|Number of Subjects Who Had Anti-motavizumab Antibodies Detected|ECLA-based method|Days 0-150|Evaluable for ADA Population; includes all motavizumab-treated subjects who received the correct study drug for their first dose and did not receive commercial palivizumab before receiving any study drug.||participants|||Number
132470|NCT00534092|Other Pre-specified|Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study||3+ years following first 2 years post-X-STOP implant through IDE study|||participants|||Number
131898|NCT00538902|Primary|Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period|American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.|Week 12|Intent-to-treat population (ITT): all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study.||Participants|||Number
131899|NCT00538863|Primary|Percentage of Patients That Experienced 1 or More Adverse Events||Baseline to end of the study (up to 116 days)|Safety population: All patients who received study medication.||Percentage of patients|||Number
131900|NCT00538850|Secondary|Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing|Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.|30 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
131901|NCT00538850|Secondary|Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing|Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5*PAR5), TOTPAR10=(5*PAR5)+(5*PAR10), TOTPAR15=(5*PAR5)+(5*PAR10)+(5*PAR15), TOTPAR30=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30), TOTPAR45=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30)+(15*PAR45), TOTPAR60=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30) +(15*PAR45) +(15*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.|5 through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
131902|NCT00538850|Secondary|Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing|Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5*PID5), SPID10=(5*PID5)+(5*PID10), SPID15=(5*PID5)+(5*PID10)+(5*PID15), SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30), SPID45=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30)+(15*PID45), SPID60=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30) +(15*PID45) +(15*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.|Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
131903|NCT00538850|Primary|Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)|Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented “no pain” and 100 represented “worst possible pain” at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.|Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode|Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.||Units on a scale||Standard Deviation|Mean
131904|NCT00538785|Secondary|Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass|Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery.|Days 0-150|Evaluable for PK following cardiac surgery with cardiopulomonary bypass; all motivizumab treated subjects who underwent cardiac surgery with cardiopulmonary bypass and who received the correct dose regiment.||ug/mL||Standard Deviation|Mean
131905|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4|30 days post-dose 4|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
131906|NCT00538785|Secondary|Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3|Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3|30 days post-dose 3|Evaluable for PK population; all motavizumab-treated subjects who received any study drug and did not received commercial palivizumab. Excludes subjects after cardiopulmonary bypass surgery.||ug/mL||Standard Deviation|Mean
131911|NCT00538785|Secondary|The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.|An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory.|Days 0-150|All subjects who were randomized in Season 2||participant|||Number
131912|NCT00538785|Secondary|The Number of Subjects Hospitalized for RSV Infection.|An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy).|Days 0-150|The ITT population is the primary efficacy analysis population and consists of all subjects randomized into the study.||participants|||Number
131913|NCT00538785|Primary|Number of Subjects Reporting Laboratory Adverse Events||Days 0-150|Safety population||participants|||Number
131914|NCT00538785|Primary|Number of Subjects Reporting Serious Adverse Events Through Study Day 150|Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.||participants|||Number
131915|NCT00538785|Primary|Number of Subjects Reporting Adverse Events Through Study Day 150|Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.|Days 0-150|The Safety population included all subjects who received any study drug and had any safety follow-up.||participants|||Number
131916|NCT00538512|Secondary|Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection||one influenza season - 2007-08||||||
131917|NCT00538512|Primary|Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza||one influenza season - 2007-2008|ITT||participants|||Number
131918|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Cells per million||Standard Deviation|Geometric Mean
131919|NCT00538473|Secondary|Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains|Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines [Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Cells per million||Standard Deviation|Geometric Mean
131920|NCT00538473|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
131921|NCT00538473|Secondary|Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||fold increase||95% Confidence Interval|Mean
131922|NCT00538473|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
131923|NCT00538473|Secondary|Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
132038|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Blood Pressure|Sitting systolic and diastolic blood pressure.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||mm Hg||Standard Error|Least Squares Mean
131924|NCT00538473|Secondary|Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
131925|NCT00538473|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.|Throughout the entire study (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
131926|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
131927|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
131928|NCT00538473|Primary|Duration of Solicited General Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
131929|NCT00538473|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
131930|NCT00538473|Primary|Duration of Solicited Local Symptoms|Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.||Days||Full Range|Median
131931|NCT00538473|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.||Subjects|||Number
131932|NCT00538434|Secondary|Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)|CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.|Baseline, End of Treatment (up to 15 weeks +/- 4 days)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment; n=number of participants with a response in the given category.||percentage change in score||Standard Deviation|Mean
131933|NCT00538434|Secondary|Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment|Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week’s daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom.|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.||units on a scale||Standard Deviation|Mean
131934|NCT00538434|Primary|Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)|"The investigator completed the Physician’s EE Global Assessment based upon the participant’s reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject’s Predominant EE Symptom Assessment, the subject’s diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.~The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status."|Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)|ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.||units on a scale||Standard Deviation|Mean
131935|NCT00538434|Primary|Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels|Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.|Baseline, End of Treatment (up to 15 weeks [+/- 4 days])|ITT population: all randomized participants who received any amount of study drug.||percentage change in eosinophils/hpf||Standard Deviation|Mean
131936|NCT00536809|Secondary|Change From Baseline to Study Completion in Aspartate Aminotransferase, Alanine Aminotranferease, and Alkaline Phosphatase|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||International Units/Liter||Standard Deviation|Mean
131937|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine Clearance|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||milliliters/minute||Standard Deviation|Mean
131938|NCT00536809|Secondary|Change From Baseline to Study Completion in Creatinine, Total Bilirubin, and Direct Bilirubin|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||micromoles/Liter||Standard Deviation|Mean
131939|NCT00536809|Secondary|Change From Baseline to Study Completion in Sodium, Potassium, and Calcium|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||millimoles/Liter||Standard Deviation|Mean
131940|NCT00536809|Secondary|Change From Baseline to Study Completion in International Normalized Ratio|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||International sensitivity index 1-5||Standard Deviation|Mean
131941|NCT00536809|Secondary|Change From Baseline to Study Completion in Prothrombin Time and Partial Thromboplastin Time|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||seconds||Standard Deviation|Mean
131942|NCT00536809|Secondary|Change From Baseline to Study Completion in White Blood Cells and Platelets|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||GI/L (.25/liter)||Standard Deviation|Mean
131943|NCT00536809|Secondary|Change From Baseline to Study Completion in Hemoglobin and Neutrophils|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||grams/Liter||Standard Deviation|Mean
131944|NCT00536809|Secondary|Change From Baseline to Study Completion in Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||millimeters of mercury||Standard Deviation|Mean
131945|NCT00536809|Secondary|Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||beats per minute||Standard Deviation|Mean
131946|NCT00536809|Secondary|Change From Baseline to Study Completion in Weight|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline values to investigate what changes occurred. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Baseline to study completion (up to 135 days)|All-Treated Population for Phase II||kilograms||Standard Deviation|Mean
131947|NCT00536809|Secondary|Progression-free Survival (PFS) After Lapatinib, Oxaliplatin, and Capecitabine Administered at the MTD Level of Phase II|Both participants that entered Phase II of the study were censored for progression-free survival. Progression-free survival (PFS) is defined as the time from first dose until the first documented sign of disease progression or death due to any cause. For participants who do not progress or die, PFS was censored at the time of last radiological scan preceding the initiation of alternative anti-cancer therapy. Of the 2 participants in Phase II of the study, one discontinued due to adverse events, and the other was referred for a surgical resection.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 135 Days)|All-Treated Population for Phase II||days||Standard Deviation|Median
131948|NCT00536809|Secondary|Genetic Variants in Germline (Host) DNA and Comparison to the Efficacy and Safety of the Study Drugs|This outcome measure was conducted to investigate a possible genetic relationship to handling or response to lapatinib, oxaliplatin, and capecitabine. This measure was not analyzed due to the small number of participants who signed the optional pharmacogenetics consent.|Optional pharmacogenetics sample may be collected at any time during the study after consent has been obtained; however, it is recommended that it be collected at the earliest time point possible|Participants in the All-Treated Population who signed a PGx informed consent.||Number of variants per exon or gene|||Number
131949|NCT00536809|Secondary|Genetic Aberrations in Somatic (Tumor) DNA Derived From the Tumor Tissue Biopsies That May Associate With Clinical Outcomes in Response to Therapy|DNA sequencing was done to identify genetic aberrations in somatic (tumor) DNA that may associate with clinical outcomes in response to therapy. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at end of Cycle 2, +/-3 days from Cycle 3.|All-Treated population for Phase II||Number of aberrations per exon or gene||Standard Deviation|Mean
131950|NCT00536809|Secondary|Tumor-derived Biomarkers (Encoded in Protein or RNA) Associated With Clinical Outcome to Treatment|Exploring tumor-derived biomarkers including TS, DPD, TP, EGFR (ErbB1), and additional downstream markers involved in the mechanism of action of each compound (e.g., ERCC1) and comparison to clinical response. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Pre-treatment tumor sample should have been provided for the most recent biopsy (not older than 5 years) prior to dosing. The post-treatment sample is suggested, not mandatory, and should have been collected at 43 +/-3 days.|All-Treated population for Phase II||Relative value comparison||Standard Deviation|Mean
131951|NCT00536809|Secondary|Effect of Lapatinib, Oxaliplatin, and Capecitabine on Plasma TS mRNA and the Relationship Between Plasma TS mRNA and Clinical Response|A possible association between a reduction in thymidylate synthase (TS) gene expression and increased sensitivity in clinical activity was to be explored. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Blood samples were collected to determine TS levels at screening phase; Days 43 and 85; after every 2 cycles of treatment (+/- 3 days); and at discontinuation (if possible).|All-Treated population for Phase II||Relative value comparison||Standard Deviation|Mean
131952|NCT00536809|Secondary|Relationship Between Pretreatment Plasma TS mRNA and Pretreatment Tumor TS mRNA in Colon Tumor Biopsies.|Exploring if there is an association with a reduction in thymidylate synthase (TS) gene expression in both plasma and tumor prior to treatment and increased sensitivity in clinical activity. This analysis was not completed due to the study being closed early and the small number of participants enrolled in Phase II.|Plasma TS mRNA is collected at screening. Pre-treatment tumor sample can be archived tissue if collected within 5 years from screening; if not, tumor sample should be collected at screening.|All-Treated population for Phase II||Relative value comparison||Standard Deviation|Mean
131953|NCT00536809|Primary|Overall Response in Phase II|The overall response is defined as the number of participants whose tumor response was classified as a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) per Response Evaluation Criteria in Solid Tumors. Response was measured for participants in Phase II only. To determine response, radiographic images were taken at baseline, 8 weeks, and every 8 weeks thereafter until the participant withdrew from the study.|Baseline to response (up to 135 days)|All-Treated Population for Phase II: all participants who received at least one dose of lapatinib||participants|||Number
131954|NCT00536744|Secondary|Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application||12 weeks post initial application and 24 weeks post initial application||||||
131955|NCT00536744|Primary|The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.||12 weeks post initial application|ITT||participants||95% Confidence Interval|Number
131956|NCT00536731|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)|Baseline to 6 weeks|||Liters||Standard Deviation|Mean
131957|NCT00536731|Secondary|Percentage of Rescue Free Days|Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication.|Baseline to 6 weeks|||Percentage of days||Standard Deviation|Mean
131958|NCT00536731|Secondary|Percentage of Asthma Control Days|Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication.|Baseline to 6 weeks|||Percentage of days||Standard Deviation|Mean
132698|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment|Other skin lesions included presence or absence of xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
131959|NCT00536731|Secondary|Percentage of Symptom-free Days|Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma.|Baseline to 6 weeks|||Percentage of days||Standard Deviation|Mean
131960|NCT00536731|Secondary|Use of Rescue Medication, Total|Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks|||Inhalations||Standard Deviation|Mean
131961|NCT00536731|Secondary|Use of Rescue Medication, Day|Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks|||Inhalations||Standard Deviation|Mean
131962|NCT00536731|Secondary|Use of Rescue Medication, Night|Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed|Baseline to 6 weeks|||Inhalations||Standard Deviation|Mean
131963|NCT00536731|Secondary|Percentage of Nights With Awakenings Due to Asthma|"Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered Yes or No whether she/he woke up during the night due to asthma."|Baseline and 6 weeks|||Percentage of night||Standard Deviation|Mean
131964|NCT00536731|Secondary|Asthma Symptom Score, Total|Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks|||Units on a scale||Standard Deviation|Mean
131965|NCT00536731|Secondary|Asthma Symptom Score, Day|Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks|||Units on a scale||Standard Deviation|Mean
131966|NCT00536731|Secondary|Asthma Symptom Score, Night|Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.|Baseline to 6 weeks|||Units on a scale||Standard Deviation|Mean
131967|NCT00536731|Secondary|Evening Peak Expiratory Flow (PEF)|Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks|||Liters/min||Standard Deviation|Mean
131968|NCT00536731|Primary|Morning Peak Expiratory Flow (PEF)|Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed|Baseline to 6 weeks|||Liters/min||Standard Deviation|Mean
131969|NCT00538304|Secondary|Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1|Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked “Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?”. The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor’s office told them to expect.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Patients|||Number
131970|NCT00538304|Secondary|Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1|Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked “Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Patients|||Number
131971|NCT00538304|Secondary|Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1|Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked “Overall, based on how well this drug lowered THIS patient’s IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason.|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Physicians|||Number
136099|NCT00508027|Other Pre-specified|Change in Plasma VCAM1 Levels|Change in plasma vascular cellular adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days|||ng/mL||Standard Deviation|Mean
131972|NCT00538304|Secondary|Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1|Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||millimeters of mercury (mmHg)||Standard Deviation|Mean
131973|NCT00538304|Secondary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1|Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).|Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Percentage of Patients|||Number
131974|NCT00538304|Primary|Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1|Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.|Baseline, Month 1|Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.||Number on a scale (score)||Standard Deviation|Mean
131975|NCT00538291|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Assessment after every 2 cycles of treatment, up to 1 year.|The three patients not completing at least two courses of treatment were considered treatment failures and were included in efficacy analysis.||number of responding participants|||Number
131976|NCT00538213|Secondary|The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||CD8 cells/10^6 CD8+ cells||Standard Deviation|Geometric Mean
131977|NCT00538213|Secondary|The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker|The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||CD4 cells/10^6 CD4+ cells||Standard Deviation|Geometric Mean
131978|NCT00538213|Secondary|The Number of Subjects Seroprotected to HI Antibodies|Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||subjects|||Number
131979|NCT00538213|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||fold increase||95% Confidence Interval|Geometric Mean
131980|NCT00538213|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||subjects|||Number
131981|NCT00538213|Secondary|The Number of Subjects Seropositive to HI Antibodies|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||subjects|||Number
131982|NCT00538213|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity were available at day 21.||titer||95% Confidence Interval|Geometric Mean
131995|NCT00537979|Primary|Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level|Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.||participants|||Number
131983|NCT00538213|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
131984|NCT00538213|Primary|Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
131985|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
131986|NCT00538213|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
131987|NCT00538213|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
131988|NCT00538213|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
131989|NCT00538213|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. >100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
131990|NCT00537979|Secondary|Health-related Quality of Life With Paricalcitol Injection or Oral Treatment|Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.|Baseline and 24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.||Participants|||Number
131991|NCT00537979|Secondary|Duration of Response to Treatment|Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.||days||Standard Deviation|Mean
131992|NCT00537979|Secondary|Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level|Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.|24 weeks|The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants.||days||Standard Deviation|Mean
131993|NCT00537979|Secondary|Proportion of Subjects Who Achieve an iPTH <300 pg/mL|Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.|24 weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.||participants|||Number
131994|NCT00537979|Secondary|Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)|Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.|24 Weeks|The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.||participants|||Number
132005|NCT00536575|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The percentage of patients who experience an objective benefit from treatment, determined by the treating physician after reviewing key laboratory values from blood and urine.|24 months|||percentage of participants|||Number
131996|NCT00537940|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specifictime points for each arm group, respectively.||percentage of participants|||Number
131997|NCT00537940|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score.|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range:0-100; higher score=more intensity of attribute.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.||Units on a scale||Standard Error|Least Squares Mean
131998|NCT00537940|Secondary|Hospital Anxiety and Depression Scale (HADS) Score.|HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 21|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||Units on a scale||Standard Error|Least Squares Mean
131999|NCT00537940|Secondary|Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.|SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n is the number of participants analyzed for SGTC. Twenty-six participants were not included in the n because they did not have a post Baseline all partial seizure, but they were included in the analysis by seizure type.||percentage of responders||95% Confidence Interval|Number
132000|NCT00537940|Secondary|Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.|Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|SGTC population included all participants who had at least 1 SGTC seizure during either Baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of all partial seizure/28days||Standard Deviation|Mean
132001|NCT00537940|Secondary|Percentage of Participants Without Seizures.|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
132002|NCT00537940|Secondary|Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline <= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of participants that can be analyzed for each treatment group.||Percentage of participants||95% Confidence Interval|Number
132003|NCT00537940|Secondary|Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.|Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline <= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 Baseline and post Baseline primary efficacy evaluation. n=is the number of subjects that can be analyzed for each treatment group.||Percentage of participants||95% Confidence Interval|Number
132004|NCT00537940|Primary|Percent Change From Baseline in 28-day Seizure Frequency at Week 21.|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant’s 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]).|6 weeks Baseline, 21 weeks through End of MP for 27 weeks|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.||percent change||Full Range|Median
132006|NCT00536510|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks|Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.||Percent Change||95% Confidence Interval|Least Squares Mean
132007|NCT00536510|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks|Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100|12 weeks|Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12.||Percent Change||95% Confidence Interval|Least Squares Mean
132008|NCT00536484|Secondary|Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline|"The urgency severity VAS Scale records the subject’s assessment of the severity of urgency. VAS scale ranges from 1 ‘Very Mild’ to 10 ‘Very Severe’. Negative change indicated improvement.~Change: mean at observation minus mean at baseline."|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).~Number analyzed=participants at Week 12 LOCF"||scores on a scale||Standard Error|Least Squares Mean
132009|NCT00536484|Secondary|Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline|"UPS scores range from 0 (I am usually not able to hold urine) to 2 (I am usually able to finish what I am doing before going to the toilet [without leaking]). Improvement: positive score change; No change: score change=0; Deterioration: negative score change"|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.~Number analyzed=participants at Week 12 LOCF."||percentage of participants|||Number
132010|NCT00536484|Secondary|Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline|PPBC scale range: 1=’does not cause me any problems at all’ to 6=’causes me many severe problems’. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.~Number analyzed=participants at Week 12 LOCF."||percentage of participants|||Number
132011|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement.~Change: mean at Week 12 minus mean at baseline."|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"||scores on a scale||Standard Error|Least Squares Mean
132012|NCT00536484|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale|"Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement.~Change: mean at Week 12 minus mean at baseline"|Baseline and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline"||scores on a scale||Standard Error|Least Squares Mean
132013|NCT00536484|Secondary|Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline|Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement|Baseline, Week 2, Week 6 and Week 12|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).~Number analyzed=participants at Week 12 LOCF."||scores on a scale||Standard Error|Least Squares Mean
132014|NCT00536484|Secondary|Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Nocturnal Urgency Episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
132015|NCT00536484|Secondary|Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline|Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Nocturnal Micturitions >0 per 24 and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
132034|NCT00536471|Secondary|Abnormal Vital Signs at Anytime Over 9 Months||over 9 months|Number of participants with a normal baseline and at least oone post-baseline measurement.||participants|||Number
132016|NCT00536484|Secondary|Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline|Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
132017|NCT00536484|Secondary|Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only those with at least 1 episode during baseline 3-day diary period were included.||number of episodes per 24 hours||Standard Error|Least Squares Mean
132018|NCT00536484|Secondary|Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline|Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.|Baseline, Week 2, Week 6 and Week 12|Number of subjects with Baseline Urgency Episodes >0 per 24 hours and non missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.||number of episodes per 24 hours||Standard Error|Least Squares Mean
132019|NCT00536484|Secondary|Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.~Change: mean at observation minus mean at baseline"|Baseline, Week 2 and Week 6|"Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2 or Week 6 (last observation carried forward [LOCF]).~The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline (n=placebo; n=fesoterodine)"||number of episodes per 24 hours||Standard Error|Least Squares Mean
132020|NCT00536484|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.|"The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.~Change: mean at Week 12 minus mean at Baseline"|Baseline and Week 12|Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward [LOCF)). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline.||number of episodes per 24 hours||Standard Error|Least Squares Mean
132021|NCT00536471|Secondary|Summary of Adverse Events Leading to Discontinuation||over 9 months|Number of randomized participants in each treatment group.||participants|||Number
132022|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
132023|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime During 9 Months||over 9 months|Number of participants with a normal baseline at at least one post-baseline measurement.||participants|||Number
132024|NCT00536471|Secondary|Statistically Significant Abnormal Laboratory Values at Anytime/12 Week Endpoint|The number of participants with statistically significant abnormal lab values at anytime and at 12 week endpoint were the same.|over 3 months|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
132025|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Hemoglobin||Baseline, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||millimoles per Liter (iron)||Standard Deviation|Least Squares Mean
132026|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 9 Month Endpoint Laboratory Values - Alkaline Phosphatase||baseline, 9 months|Number of participants with non-missing data at baseline and at least one post baseline visit.||Units per Liter||Standard Deviation|Least Squares Mean
132027|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Platelet Count||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least post-baseline visit.||Billions per Liter||Standard Deviation|Least Squares Mean
132028|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Chloride, Urea Nitrogen, Cholesterol, Sodium||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||millimole per Liter||Standard Deviation|Least Squares Mean
132029|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Mean Cell Volume (MCV)||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||femtoliter||Standard Deviation|Least Squares Mean
132030|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Hematocrit||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||Proportion of 1.0||Standard Deviation|Least Squares Mean
132031|NCT00536471|Secondary|Statistically Significant Changes in Baseline to 12 Week and 9 Month Endpoints Laboratory Values - Bilirubin, Creatinine, Uric Acid||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and at least one post-baseline visit.||micromole per Liter||Standard Deviation|Least Squares Mean
132032|NCT00536471|Secondary|Abnormal Vital Signs at 9 Month Endpoint||9 months|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
132033|NCT00536471|Secondary|Abnormal Vital Signs at 12 Week Endpoint||12 weeks|Number of participants with a normal baseline and at least one post-baseline measurement.||participants|||Number
132039|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Social Adaptation Self-evaluation Scale (SASS) Total Score|A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132040|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ)|A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132041|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132042|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in Pain Numerical Rating Scale (NRS)|Item 1=Average musculoskeletal pain severity over the last week as measured by an 11-point Likert scale. Scores range from 0 (no pain) to 10 (worst possible pain). Item 7=How much they have been bothered by pain over the last week. Scores range from 0 (not bothered at all)to 10 (extremely bothered).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Deviation|Least Squares Mean
132043|NCT00536471|Secondary|Probability of Response at 12 Week Endpoint|Probability of response as measured by ≥ 50% Improvement in the HAMD17 Total Score and ≥ 50% Improvement in the QIDS16SR Total Score. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for response (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||probability of response||Standard Error|Least Squares Mean
132044|NCT00536471|Secondary|Probability of Remission at 12 Week Endpoint and Sustained Remission at 9 Month Endpoint|Probability of remission as measured by the HAMD17 Total Score ≤ 7 and by the QIDS16SR Total Score ≤ 5. The visitwise percentages of patients meeting criteria in the Acute Therapy Phase for remission (visitwise binary outcome, yes/no) will be analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis will include the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||probability of remission||Standard Error|Least Squares Mean
132045|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Total Score|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Deviation|Least Squares Mean
132046|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in SDS Total Score - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|Over 12 weeks|||percent of total effect|||Number
132047|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in Sheehan Disability Scale (SDS) Total Score|Relative contribution of improvement on the mood states, defined by BPOMS total score (determined from subscales) to overall improvement in SDS total score using path analysis.|over 12 weeks|||coefficient|||Number
132048|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7 - Percent of Total Effect|For Group A, at least one effect was in the opposite direction, percent of total effect was not calculated.|over 12 weeks|||percent of total effect|||Number
132049|NCT00536471|Secondary|Path Analysis of BPOMS Total Score to Overall Improvement in HAMD-24 Item 7|Relative contribution of improvement on the mood states, defined by BPOMS total score (calculated from subscales) to overall improvement in work and activities, HAMD-24 item 7 using path analysis.|Over 12 weeks|||coefficient|||Number
132050|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132051|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Individual item scores range from 0 to 10. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132052|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment)|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132053|NCT00536471|Secondary|Change From Baseline to 12 Week Endpoint in 30-Item Brief Profile of Mood States (BPOMS) Scale and Subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment).|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).|Baseline, 12 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132054|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 24B:Worthlessness|Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132055|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 23B:Hopelessness|Measures feelings of hopelessness on a scale of 0 (absent) to 4 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132056|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 22B:Helplessness|Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132057|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 21:Obsessional and Compulsive Symptoms|Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132058|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 20:Paranoid Symptoms|Measures paranoid symptoms on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132059|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 19: Depersonalization and Derealization|Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132060|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18B:Diurnal Variation-Severity|Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132061|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 18A:Diurnal Variation|Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132062|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight|Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132063|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight|Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132064|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis|Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132065|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms|Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132066|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General|Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132067|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal|Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132068|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)|Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132069|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)|Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132070|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation|Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
133855|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
132071|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation|Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132072|NCT00536471|Secondary|Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|Baseline, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132073|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late|Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132074|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle|Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132075|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early|Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132076|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide|Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).|Baseline, 12 weeks, 9 Months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132077|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt|Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132078|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood|Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).|Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132079|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score||Baseline, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132080|NCT00536471|Secondary|Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.|Baseline, 8 weeks, 12 weeks, 9 months|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132081|NCT00536471|Primary|Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)|Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).|baseline, 8 weeks|Number of participants with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
132082|NCT00536380|Primary|Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg|The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was “reflective”, covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period.|Baseline and 4 treatment weeks|Intent to treat population||Units on a scale||Standard Error|Least Squares Mean
132083|NCT00537823|Secondary|Change in Tumor Size From Pretreatment to Preoperative CT Scan|-Compare total longest diameter from baseline to preoperative CT scan.|Completion of neoadjuvant therapy (approximately 8 weeks)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.||percentage of change of longest diameter||Full Range|Median
132084|NCT00537823|Secondary|Effect of Preoperative Chemotherapy on Tumor Size|Number of participants whose tumor size decreased from baseline to completion of preoperative chemotherapy.|Upon completion of neoadjuvant chemotherapy (approximately 2 months)|2 participants did not have the CT scan prior to surgery as both did not complete preoperative chemotherapy due to adverse skin reactions to cetuximab.||participants|||Number
132085|NCT00537823|Secondary|Liver Injury Scale Score (0-27)||Time of surgery (approximately 11-16 weeks)|Data was not collected for this outcome measure as the study pathologist left the institution early prior to study closure.|||||
132086|NCT00537823|Secondary|Nonalcoholic Steatohepatitis Score (0-3)|"NASH Scoring~Steatosis **<5% = 0~**5-33%=1~**>33-66%=2~**>66%=3~Lobular inflammation~**No foci=0~**<2 foci per x 200 field=1~**2-4 foci per x 200 field=2~**>4 foci per x 200 field=3~Hepatocellular ballooning **None=0 **Few balloon cells = 1 **Many cells/prominent ballooning=2"|Time of surgery (approximately 11-16 weeks)|"4 participants did not have surgery and are not included in this outcome measure.~The study pathologist left the university early prior to completion of study pathology for this study."||participants|||Number
132087|NCT00537823|Secondary|Histologic Hepatic Toxicity at Surgery||Time of surgery (approximately 11-16 weeks)|4 participants did not have surgery.||participants|||Number
133856|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
132088|NCT00537823|Secondary|Postoperative Recurrence Patterns|Liver only vs distant disease|Up to 5 years|7 participants were not evaluable. 4 participants did not have surgery (3 in Arm 1, 1 in Arm 2). 1 participant had surgery but was not resectable (Arm 1) . 1 participant developed another primary cancer (Arm 1). 1 participant died before recurrence from hepatic failure (Arm 1).||participants|||Number
132089|NCT00537823|Primary|All-cause Mortality||30 days following surgery|4 participants did not have surgery.||participants|||Number
132090|NCT00537823|Primary|Major Postoperative Complication Rate|Fraction of patients with any complication grades IV and V|30 days following surgery|4 participants did not have surgery.||percentage of participants|||Number
132091|NCT00537823|Primary|Postoperative Complication Rate|Fraction of patients with any grade of complication I-V|30 days following surgery|4 participants did not have surgery.||percentage of participants|||Number
132092|NCT00537810|Primary|BMI||4 months treatment|Participants with complete data reported here (i.e., no imputation)||BMI (kg/m^2)||Standard Deviation|Mean
132093|NCT00537810|Primary|Binge Eating (Remission)|Remission from binge eating (zero binge episodes during previous 28 days)|4 months treatment; 6 and 12 month follow up post treatment|||participants|||Number
132094|NCT00537771|Secondary|Time to Treatment Failure||Within 3 years|||days||95% Confidence Interval|Median
132095|NCT00537771|Secondary|Incidence of Abnormal Liver Function|The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.|At 48 weeks, 96 weeks, 144 weeks|||participants|||Number
132096|NCT00537771|Primary|Incidence of Fatty Liver Disease|The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.|At 48 weeks, 96 weeks, 144 weeks|||participants|||Number
132097|NCT00537745|Primary|% Days w/1+Interlock Test Failures|This describes the percent of days in past month where the subject at least 1 interlock test failure.|One month post treatment|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.||percent of days||Full Range|Mean
132098|NCT00537745|Primary|Evidence of Attempts to Drive After Drinking|"This was measured as Percent of days with an Interlock report of Failure to Start due to alcohol pre/on medication and 6 months post medication."|6 months|Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.||percent of days|Participants|Full Range|Mean
132099|NCT00537680|Secondary|FACT|Friedreich’s Ataxia Composite Test|6 Months||||||
132100|NCT00537680|Secondary|ADL of FARS|ADL=Activities of Daily Living|6 Months||||||
132101|NCT00537680|Secondary|FARS|Friedreich’s Ataxia Rating Scale|6 Months||||||
132102|NCT00537680|Primary|ICARS|"International Cooperative Ataxia Rating Scale (ICARS):~ICARS consists of a one-hundred-point semi-quantitative scale based upon 19 simple testing manoeuvres compartmentalized into postural and stance disorders, limb ataxia, dysarthria and oculomotor disorders and has been previously used in this patient population with good inter-rater reliability.~Scores for each subscale quantify the extent of ataxia in each clinically important area. Subscale scores are summed to give a total score ranging from 0 (best) to 100 (worst)."|baseline and 6 months|||ICARS points||Standard Deviation|Mean
132103|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).|Safety population; participants continuing in the Recovery Period and Maintenance Phase.||participants|||Number
132104|NCT00537511|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant’s health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.|Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).|Safety population||participants|||Number
132105|NCT00537511|Secondary|Overall Survival|Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis.|From enrollment through study termination (approximately 35 months)|Participants in the ITT population.||weeks||95% Confidence Interval|Median
132306|NCT00535392|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
132106|NCT00537511|Secondary|Duration of Response|Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression.|From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)|Number of participants in ITT population who were considered Responders.||weeks||Standard Deviation|Mean
132107|NCT00537511|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)|Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Cycles 1 -6 (21-day cycles)|ITT population. 'Not Assessed' category includes participants who did not have adequate data for response assessment at baseline and/or post-baseline prior to the use of any non-protocol anti-tumor therapy.||participants|||Number
132108|NCT00537511|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase|For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.|Cycles 1 - 6 (21-day cycles)|Safety Population||participants|||Number
132109|NCT00537511|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)|Cycle 1 (21 days)|Safety Population||mg|||Number
132110|NCT00537485|Secondary|The Modified Hoehn and Yahr Stage|Mean change (LOCF) from baseline in the Modified Hoehn and Yahr Severity of Illness at the end of maintenance period. The Modified Hoehn and Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.|Baseline, end of maintenance period|FAS, LOCF||Percentage of participants|||Number
132111|NCT00537485|Secondary|Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 1, 2, 3 and 4.~UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
132112|NCT00537485|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at every two weeks after dosing.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
132113|NCT00537485|Secondary|UPDRS Part 1 Sum Score|"MMean change (LOCF) from baseline in UPDRS Part 1 sum score at every two weeks after dosing.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
132114|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
132115|NCT00537485|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at every two weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|FAS, LOCF||Scores on a scale||Standard Deviation|Mean
132116|NCT00537485|Secondary|Efficacy Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.|Baseline, every two weeks|||Percentage of participants||95% Confidence Interval|Number
132117|NCT00537485|Secondary|Mean Change in UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at every two weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, every two weeks|||Scores on a scale||Standard Deviation|Mean
132118|NCT00537485|Secondary|Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in total of each sum score of UPDRS Part 2 and Part 3 at the end of maintenance period|baseline, end of maintenance period|FAS, LOCF||Percentage of participants||95% Confidence Interval|Number
132119|NCT00537485|Primary|Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3|"Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, end of maintenance period|Full analysis set (FAS), last observation carried forward (LOCF)||Scores on a scale||Standard Deviation|Mean
132120|NCT00537407|Secondary|Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96)|A participant had a sustained viral response if their viral RNA was undetectable (< 10 IU/mL).|24 weeks after the end of treatment (Week 72 or 96)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants|||Number
132121|NCT00537407|Secondary|Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72)|A participant had an end-of-treatment response if their viral RNA was undetectable (< 10 IU/mL).|End of treatment (Week 48 or 72)|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants|||Number
132122|NCT00537407|Secondary|Percentage of Participants With an Early Viral Response at Week 12|A participant had an early viral response if their viral RNA had decreased ≥ 2 log10 at Week 12 compared to Baseline.|Baseline to Week 12|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants|||Number
132123|NCT00537407|Secondary|Percentage of Participants With a Rapid Viral Response at Day 29|A participant had a rapid viral response if their viral RNA was undetectable (< 10 IU/mL).|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||percentage of participants||95% Confidence Interval|Number
132124|NCT00537407|Secondary|log10 Hepatitis C Virus RNA at Day 29|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||Log10(IU/mL)||Standard Deviation|Mean
132125|NCT00537407|Secondary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||Log10(IU/mL)||Standard Deviation|Mean
132126|NCT00537407|Primary|Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E)|Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.|Baseline to Day 29|Intent-to-treat population: All randomized participants with at least a Baseline and 1 on- or post-treatment hepatitis C virus RNA assessment.||Log10(IU/mL)||Standard Deviation|Mean
132127|NCT00537394|Secondary|Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure|Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir.|Between baseline and confirmed virologic failure (up to 96 weeks)|Those with confirmed virologic failure (N=54; N=50) among the randomized arms included; and those who were missing resistance information following virologic failure (N=2; N=4) are excluded.||participants|||Number
132128|NCT00537394|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline|Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded.|From study entry to Weeks 24, 48|All randomized participants who started study treatment. Non-fasting results and missing results excluded from analysis. Therefore, differences reported here represent a complete case analysis.||mg/dL||Standard Deviation|Mean
132129|NCT00537394|Secondary|Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry|HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure.|From study entry to time of confirmed virological failure (up to 96 weeks)|Only randomized participants with R5-tropic virus at study entry (N=89; N=88), and who experienced confirmed virologic failure (N=27; N=22) during follow-up, and who had a tropism test following failure are included.||participants|||Number
132130|NCT00537394|Secondary|Time From Treatment Dispensation to Serious Non-AIDS-defining Events|Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit.|From treatment initiation to week 96 study visit|Randomized participants were included, and those not starting study treatment were excluded.||weeks||95% Confidence Interval|Number
132131|NCT00537394|Secondary|Change in CD4 Count From Baseline|Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded.|From study entry to Weeks 48 and 96|All subjects in the two randomized arms were assessed.||cells/mm^3||Inter-Quartile Range|Median
132303|NCT00535405|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12||Baseline and 12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent change in LDL-C||95% Confidence Interval|Least Squares Mean
132132|NCT00537394|Secondary|Change in Cardiovascular Risk Score From Baseline|Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score.|At Weeks 24, 48, and 96|Persons not starting treatment (N=1; N=2), who had cardiovascular disease prior to study entry (N=12; N=8), or were missing input values needed to calculate a baseline Framingham score (N= 6; N=4), were excluded.||units on a scale||Standard Deviation|Mean
132133|NCT00537394|Secondary|Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable)|Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent.|At Weeks 24 and 48|Persons not starting study treatment, or not receiving assigned study treatment by randomization were excluded from all analyses. If person no longer in study follow-up before beginning of week 24 or 48 evaluation window, additionally excluded as applicable.||participants|||Number
132134|NCT00537394|Secondary|Change in Summarized Quality of Life Score|Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health).|At study entry and Weeks 24, 48, 96|Two randomized arms only.||units on a scale||Inter-Quartile Range|Median
132135|NCT00537394|Secondary|Change in Plasma HIV-1 Viral Load From Baseline to Week 1|Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL.|From baseline to Week 1 evaluation|Modified intent to treat population among two randomized arms only: 2 participants (both in Omit NRTIs arm) were excluded because their baseline and week 1 RNA levels were both < 50 copies/mL.||log10 copies/mL||Inter-Quartile Range|Median
132136|NCT00537394|Secondary|Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml|Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded.|At Weeks 24, 48, 96|ITT - among 2 randomized arms only; closest value to scheduled week used if multiple values available; missing values excluded. Numbers analyzed at each time point represent those with a valid RNA result.||participants|||Number
132137|NCT00537394|Secondary|Time From Randomization to Confirmed Virological Failure|Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested.|From randomization to week 96 study visit|ITT (all randomized participants) included.||weeks||95% Confidence Interval|Number
132138|NCT00537394|Secondary|Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment|Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation.|From randomization to week 96 study visit|All randomized participants included (i.e. ITT analysis).||weeks||95% Confidence Interval|Number
132139|NCT00537394|Secondary|Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable)|First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization.|From treatment dispensation to week 96 study visit|Only randomized participants included, and those who never started study treatment were excluded.||weeks||95% Confidence Interval|Number
132140|NCT00537394|Secondary|Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality|Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality).|From treatment dispensation to week 96 study visit|Only randomized participants included. Persons not starting study treatment excluded.||weeks||95% Confidence Interval|Number
132157|NCT00537329|Secondary|Number of Subjects With Clinical Response of Success at Endpoints|Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."||participants|||Number
136100|NCT00508027|Other Pre-specified|Change in Plasma VEGF Levels|Change in plasma vascular endothelial adhesion molecule-1 levels after treatment with simvastatin|Baseline, 21 days|||pg/mL||Standard Deviation|Mean
132141|NCT00537394|Primary|Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment|Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method.|From study entry to end of Week 48 evaluation window|Analysis uses intent to treat population, among the two randomized arms only.||percentage of participants||95% Confidence Interval|Number
132142|NCT00537381|Secondary|Percent Change From Baseline in ‘Vascular Endothelial Growth Factor (VEGF)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Percent change||Standard Deviation|Mean
132143|NCT00537381|Secondary|Percent Change From Baseline in ‘N-telopeptide of Type I Collagen (NTx)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Percent change||Standard Deviation|Mean
132144|NCT00537381|Secondary|Percent Change From Baseline in ‘C-telopeptide of Type I Collagen (CTx)’ Marker Concentration|Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.|Baseline, Week 6, 7, 10 and 13|The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.||Percent change||Standard Deviation|Mean
132145|NCT00537381|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline until death (up to 887 days)|Efficacy population included all participants randomly assigned to study treatment.||Days||95% Confidence Interval|Median
132146|NCT00537381|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).|Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days|Included all participants randomly assigned to study treatment and had baseline PSA evaluation and at least two post-baseline evaluations that are at least 3 weeks apart.||Participants|||Number
132147|NCT00537381|Secondary|Number of Participants With Best Overall Response (OR)|Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Response evaluable population included participants who had target lesion or non-target lesion at baseline and received at least 1 study treatment and had at least 1 post-baseline response assessment or discontinued study treatment due to disease progression, or death.||Participants|||Number
132148|NCT00537381|Primary|Progression-Free Survival (PFS)|The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to 6 months after last dose of study treatment, assessed up to 551 days|Efficacy population included all participants randomly assigned to study treatment.||Days||95% Confidence Interval|Median
132149|NCT00537329|Secondary|Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups|Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.|EOT (Day 5 up to Day 42)|MITT. May have >1 baseline pathogen; previous surgery=any surgery (includes abdominal surgery) within 1 month prior to baseline (PTB); chemotherapy for solid cell tumors or hematological malignancies at baseline or within 3 months PTB; central venous catheter (CVC) up to 1 month PTB; (n)=subjects per subgroup with analyzable data at observation.||participants|||Number
132173|NCT00537277|Secondary|Number of Nocturnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||episodes|||Number
132150|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT|Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject’s EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."||percent change||Standard Deviation|Mean
132151|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject’s at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT."||pg/mL||Standard Deviation|Mean
132152|NCT00537329|Secondary|Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."||percent change||Standard Deviation|Mean
132153|NCT00537329|Secondary|Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment|Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject’s at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.|Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)|"MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT."||pg/mL||Standard Deviation|Mean
132154|NCT00537329|Secondary|Time to Death Due to Candidemia|"Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population.||days||Full Range|Median
132155|NCT00537329|Secondary|Time to Death From Any Cause|"Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."|Baseline through end of 12 weeks after baseline|MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; < 50% of subjects died out of the analyzable population.||days||Full Range|Median
132156|NCT00537329|Secondary|Number of Subjects With Microbiological Response of Success at Endpoints|Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.|EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline|"MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."||participants|||Number
132184|NCT00537238|Secondary|Percent Change From Baseline in 28 Day Seizure Frequency at Week 16|The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant’s 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline.|Baseline, Week 16|Full analysis set (FAS) included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation.||percent change||Full Range|Median
132158|NCT00537329|Secondary|Number of Subjects With Global Response of Success at Endpoints|Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.|End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)|"MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT)."||participants|||Number
132159|NCT00537329|Primary|Number of Subjects With Global Response of Success at End of Treatment|Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.|End of treatment (EOT) = Day 5 up to Day 42|Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment.||participants|||Number
132160|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study|Weeks 38, 62 and 94 (Weeks 22, 46 and 78 for direct entry)||||||
132161|NCT00537316|Secondary|Proportion of Participants Who Are in Steroid-free Remission During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study.|Weeks 38, 62 & 94 (Weeks 22, 46 and 78 for direct entry)||||||
132162|NCT00537316|Secondary|Proportion of Participants With Mucosal Healing at Week 16|Mucosal healing was defined as a Mayo endoscopy score of 0 or 1.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation).||Proportion of participants|||Number
132163|NCT00537316|Secondary|Proportion of Participants in Response at Weeks 8 and 16|Response at Week 8 is defined as a decrease in the partial Mayo score of ≥1 point. Response at Week 16 is defined as a decrease in total Mayo score of ≥3 points and at least 30% lower than baseline Mayo score. The partial Mayo score consists of the following 3 sub-scores: stool frequency, rectal bleeding, and physician’s global assessment. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician’s global assessment.|Weeks 8 and 16|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-responders) at Week 16.||Proportion of participants|||Number
132164|NCT00537316|Primary|Average Remission Rate During Part 2 of the Study|Due to the early termination of this study, evaluations of efficacy were not conducted for Part 2 of the study (Week 38 through Week 94 [Week 22 through Week 78 for direct entry]).|up to Week 94 (Week 78 for direct entry)||||||
132165|NCT00537316|Primary|Proportion of Participants in Steroid-free Remission at Week 16|Steroid-free remission is defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point, without the use of corticosteroids. The total Mayo score consists of the following 4 sub-scores: stool frequency, rectal bleeding, findings of endoscopy (sigmoidoscopy), and physician’s global assessment.|16 weeks|Full Analysis Set (participants who were randomized, received at least one dose of study treatment, and had data available for baseline and at least one post baseline evaluation). Participants who dropped out prior to Week 16, had a missing Mayo score at Week 16, or were non-responders at Week 8 are considered failures (non-remission) at Week 16.||Proportion of participants|||Number
132166|NCT00537303|Secondary|Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide|High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||mg/L||Standard Deviation|Mean
132167|NCT00537303|Secondary|Haematology: Haemoglobin Measured in Blood|Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||mmol/L||Standard Deviation|Mean
132168|NCT00537303|Secondary|Biochemistry: Serum Alanine Aminotransferase|Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.|week 36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||U/L||Standard Deviation|Mean
132169|NCT00537303|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-36|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.||episodes|||Number
132170|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Measured for the Per Protocol analysis set.|week 36|Per Protocol analysis set: All exposed subjects who completed the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the efficacy results.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
132171|NCT00537303|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Analysed for the full analysis set.|week 36|Full analysis set (FAS) is all randomised subjects exposed to at least one dose of trial products.||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
132172|NCT00537277|Secondary|Number of Treatment Emergent Serious Adverse Events (SAEs)|Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||events|||Number
132174|NCT00537277|Secondary|Number of Diurnal Hypoglycaemic Episodes|Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||episodes|||Number
132175|NCT00537277|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.|weeks 0-48|Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.||episodes|||Number
132176|NCT00537277|Secondary|Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.||percentage of trial completers|||Number
132177|NCT00537277|Primary|Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%||week 48|Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.||percentage of subjects|||Number
132178|NCT00537238|Secondary|Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
132179|NCT00537238|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) Score|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study medication and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Least Squares Mean
132180|NCT00537238|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Least Squares Mean
132181|NCT00537238|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up|BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment.|Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. n=number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Least Squares Mean
132182|NCT00537238|Secondary|Percentage of Participants Without Seizures|Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.|Baseline up to Week 16|FAS included all randomized participants who had received at least 1 blinded dose of study drug and had at least 1 baseline and post baseline primary efficacy evaluation. N (number of participants analyzed)=participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
132183|NCT00537238|Secondary|Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16|Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures.|Baseline, Week 16|SGTC population included all participants who had at least 1 SGTC seizure during either baseline or double-blind phase. n=number of participants evaluable at specific time points for each arm group, respectively.||percentage of all partial seizure/28days||Standard Deviation|Mean
136101|NCT00508027|Other Pre-specified|Change in Plasma IL-6 Levels|Change in plasma IL-6 level after treatment with simvastatin|Baseline, 21 days|||pg/mL||Standard Deviation|Mean
132185|NCT00537238|Primary|Proportion of Participants With Response to Treatment|Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.|Baseline up to Week 16|Per protocol population included all randomized participants who had at least 28 days of study drug during the maintenance phase and a minimum of 28 days of utilizable seizure diary data during baseline and maintenance phases of the study and had no major protocol violation.||proportion of participants|||Number
132186|NCT00537199|Primary|Ratio (Percentage) of Sensitivity of OraTest + Visual Exam Versus Sensitivity of Visual Exam Alone|"Primary efficacy parameters, ratio of sensitivity of OraTest® in combination with visual exam versus visual exam alone is the difference between the adjusted specificity for OraTest in combination with visual exam and the adjusted specificity for visual exam alone.~Reported ratio as percentage of patients with abnormalities (suspicious lesions) found upon visual exam of the mouth with and without OraTest® dye."|Following two (2) scheduled visits for visual examination, up to one month following first exam|No analysis was performed. Study was terminated by sponsor.|||||
132187|NCT00537095|Secondary|Time to Death|Interim analysis time to date of randomisation to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.|time from randomisation to date of death|For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo||participants|||Number
132188|NCT00537095|Secondary|Objective Response Rate|Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria|46.7 months|||participants|||Number
132189|NCT00537095|Secondary|Disease Control Rate at 6 Months|number of participants that achieved disease control 6 months after randomisation. Best objective response of complete response + partial response + stable disease > 24 weeks according to RECIST criteria|6 months after randomisation|||participants|||Number
132190|NCT00537095|Primary|Time to Tumor Progression|modified RECIST V1.0 was used|Time from date of randomisation to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment|||days||95% Confidence Interval|Median
132191|NCT00537082|Secondary|Annualized Relapse Rate (ARR) at 6 Months|Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.|6 Months|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.||Relapses per year|||Number
132192|NCT00537082|Secondary|Number of Patients Free of New or Newly Enlarged T2 Lesions|The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion.|up to Month 3 and up to Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.||Participants|||Number
132193|NCT00537082|Secondary|Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)|A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).|up to Month 6|Full Analysis Set (FAS) consisted of all patients who were randomized and received at least one dose of study drug. This population was only used for the analyses of relapse and EDSS.||Participants|||Number
132194|NCT00537082|Primary|Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6|Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.|Month 3 and Month 6|Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.||Participants|||Number
132195|NCT00537030|Secondary|Frequency of Asparaginase-related Toxicities Following Erwinase® Treatment.|As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The incidence of these toxicities will be described. The percentage of patients that have Erwinase® therapy discontinued due to the above toxicities will also be estimated. With a sample size of 50, the incidence of the above toxicities can be estimated with a maximum standard error of 7%.|At each course of Erwinase® treatment||||||
132196|NCT00537030|Secondary|Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase|An ELISA (enzyme-linked immunosorbent assay) method will be used to determine the presence of specific anti-Erwinia and anti-PEG-asparaginase antibodies at baseline, and of specific anti-Erwinia asparaginase antibodies after first and subsequent exposures to Erwinase®. The rate of antibody formation will be described and compared informally to experience in CCG-1962 and 1961. Serum asparaginase activity will be compared during Erwinase® courses as an indication of the neutralizing effect of antibodies on the enzyme effect.|At baseline, prior to doses 4, 5, and 6 and on days 15 and 22||||||
132197|NCT00537030|Secondary|Determine if Plasma Asparagine is Adequately Depleted|Plasma asparagine depletion will be determined in a subset of 20 patients limited to participating Phase I Institutions.|On days 12 or 13||||||
132198|NCT00537030|Primary|Trough Serum Asparaginase Activity|To determine if the 48 hour trough serum asparaginase activity is ≥ 0.1 IU/mL in at least 70% of patients.|Measured in blood at 48 hours post administration of Erwinia asparaginase|Of the 59 enrolled participants, there was 1 ineligible participant and 3 inevaluable participants that were not analyzed leaving a total of 55 participants. Of those 55 participants, 20 participants had an insufficient sample at 48 hours, where a total of 35 participants were analyzed.||IU/mL of Asparaginase Activity||Full Range|Median
132199|NCT00537017|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 42 weeks|All participants who received treatment with study drug were included in the analysis.||Participants|||Number
132200|NCT00537017|Secondary|Total Sleep Time|Participant diaries recorded time spent in the sleep state at half-hourly intervals for at least 3 full days before scheduled visits. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175.|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
132201|NCT00537017|Secondary|Absolute Duration of Dyskinesias|"Participant diaries recorded time spent in the on state with dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify worsening of dyskinesia (i.e., more time spent with dyskinesia). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
132202|NCT00537017|Secondary|"Time Spent in the on State Without Troublesome Dyskinesia"|"Participant diaries recorded time spent in the on state without troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well) concomitant with absence of troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
132203|NCT00537017|Secondary|"Time Spent in the on State With Troublesome Dyskinesias"|"Participant diaries recorded time spent in the on state with troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well) concomitant with troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
132204|NCT00537017|Secondary|"Time Spent in the on State With no Dyskinesias"|"Participant diaries recorded time spent in the on state with no dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the on time. Higher values relative to BL signify an improvement in the Parkinson’s disease symptoms (i.e., participant can move well) concomitant with no dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
132205|NCT00537017|Secondary|"Awake Time Per Day in the on State"|"Participant diaries recorded time spent in the on state at half-hourly intervals for at least 3 full days before scheduled visits. “On” time is defined as when the participant’s medication is working as subjectively determined by the participant and his/her physician. Higher on time values relative to BL mean that the Parkinson’s disease symptoms are better or absent (i.e., participant can move well). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||hours/day||Standard Deviation|Mean
132227|NCT00536198|Secondary|DRSP Depression Subscale|Depressive symptoms included: felt depressed, felt hopeless, felt worthless or guilt, slept more, trouble sleeping, felt overwhelmed. Symptoms were scored on a scale of 1-6 The score range is 0-36 with higher indicating greater severity.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
132206|NCT00537017|Secondary|"Time Spent in Off State Per Day"|"Participant diaires recorded time spent in the off state at half-hourly intervals for at least 3 full days before scheduled visits. “Off” time is defined as when the participant’s medication is not working as subjectively determined by the participant and his/her physician. Higher off time values relative to Baseline (BL) signify that the Parkinson’s disease symptoms are worse (i.e., participant can only move slowly or not at all). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175."|Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36|All participants with a baseline value and at least one post-baseline value were included in the analysis.||Hours/day||Standard Deviation|Mean
132207|NCT00536978|Secondary|One-year Disease-free Survival (DFS)|Efficacy (disease-free-survival) defined as number of participants still living, without disease progression following T- cell or Natural killer (NK) cell adback. One-year disease-free survival (DFS) time estimated using the Kaplan-Meier estimator. Patients who experience disease recurrence considered to be a treatment failure event.|1 Year||||||
132208|NCT00536978|Primary|6-month Treatment Related Mortality (TRM)|Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.|6 Months|Of the 22 patients enrolled, none received the adback T-Cell or NK cells treatment.||participants|||Number
132209|NCT00536341|Secondary|Overall Survival|Defined as the time from Day 1 of treatment administration to date of death from any cause, estimated using Kaplan-Meier methods.|Every 3 months until treatment discontinuation, expected average of 6 months and then every 6 months thereafter up to 5 years|All treated patients, all dose levels||months||95% Confidence Interval|Median
132210|NCT00536341|Secondary|Progression-Free Survival|Measured from first treatment to disease progression and assessed using Kaplan-Meier methods.|Every 3 months during treatment until disease progression and every 6 months thereafter, up to 5 years|All treated patients, all dose levels||months||95% Confidence Interval|Median
132211|NCT00536341|Primary|Complete Response Rate|An improvement in complete response to at least 60% following treatment, assessed using CT scans, clinical/lab examinations, and bone marrow aspirations, as defined by National Cancer Institute Working Group Response Criteria.|At 12 weeks during treatment and 2 months post-treatment until disease progression, projected 8 months|All patients deemed evaluable and evaluated for response||participants|||Number
132212|NCT00536341|Primary|Number of Adverse Events as a Measure of Safety and Tolerability|Recorded from first treatment until 30 days after last treatment and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|63 months|All treated patients||participants|||Number
132213|NCT00536263|Secondary|Change From Baseline in Liver Biopsy Score|"Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System):~Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis).~Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked [involvement of >2/3 of lobules or nodules]).~Score III (portal inflammation): 0 (none) to 4 (Marked [dense packing of~inflammatory cells in >2/3 of portal tracts]).~Score IV (fibrosis): 0 (none) to 4 (cirrhosis)."|Baseline to 24 weeks after end of treatment|Treated participants from designated sites||Units on a scale||Standard Deviation|Mean
132214|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBs) Seroconversion|HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132215|NCT00536263|Secondary|Hepatitis B Surface Antigen (HBsAg) Loss|HBsAg Loss was tested by assay of Abbott MEIA|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132216|NCT00536263|Secondary|Number of Participants With Combined Response|Combined response was defined as HBV DNA <20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132217|NCT00536263|Secondary|Number of Participants With Biochemical Response|Biochemical response was defined as alanine aminotransferase (ALT) normalization.|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132218|NCT00536263|Secondary|Number of Participants With HBV-DNA Undetectable|Undetectable HBV-DNA was defined as having a level <6 IU/mL by polymerase chain reaction (PCR).|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132219|NCT00536263|Secondary|Number of Participants With HBV-DNA < 200 IU/mL|HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132220|NCT00536263|Secondary|Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL|"HBV-DNA was tested by assay of Roche Cobas Taqman (the test~lowest limit is 6 IU/mL)"|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132221|NCT00536263|Secondary|HBe Seroconversion|HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.|End of treatment (EOT) and 24 weeks after EOT|Treated participants||Participants|||Number
132222|NCT00536263|Secondary|Number of Participants With HBeAg Loss|HBeAg Loss was tested by assay of Abbott MEIA|Up to Treatment Week 48|Treated participants||Participants|||Number
132223|NCT00536263|Primary|Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss|HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)|24 weeks after end of treatment (EOT)|Treated participants||Participants|||Number
132224|NCT00536198|Secondary|Clinical Global Impressions-Improvement (CGI-I)|The Clinical Global Impressions-Improvement (CGI-I) scale is a 7-point scale with 7 being the least improvement.|Cycle 1 to Cycle 6|all participants who were measured at a visit past baseline were analyzed||units on a scale||Standard Deviation|Mean
132225|NCT00536198|Secondary|DRSP Anger/Irritability Subscale|Anger/irritability included anger/irritability and conflicts with people. Symptoms were scored on a scale 1-6. The range is 0 to 12 with a higher score indicating greater symptom severity.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
132226|NCT00536198|Secondary|DRSP Physical Subscale|Physical symptoms included breast tenderness, bloating, headache, joint or muscle pain. Symptoms were scored on a scale of 1-6. The severity range is 0-24 with 24 being more symptomatic.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
136102|NCT00508027|Other Pre-specified|Change in Plasma Hs-CRP Levels|Change in plasma high sensitivity C-reactive protein levels in subjects treated with simvastatin|Baseline, 21 days|||mg/L||Standard Deviation|Mean
132228|NCT00536198|Primary|DRSP|DRSP (Daily Rating of Severity Problems) is composed of 21 items reflecting the 11 candidate symptoms for PMDD according to DSM IV and DSM V. Each symptom is scored 1-6. A diagnosis of PMDD requires a minimum average luteal phase score of greater than or equal to 3 (mild) for at least 5 PMDD symptoms during the five most symptomatic of the final seven luteal phase days and the first two days of menses onset, and we require that the average follicular phase score not be >2 on these same items. The minimum score is 0 and maximum is 126 for the total score. A higher score indicates greater severity of symptoms.|Baseline to Cycle 6|||units on a scale||Standard Deviation|Mean
132229|NCT00536198|Primary|Number of Symptomatic Days Before Pills Were Taken|"Symptomatic days were those that participant experienced at least 3 symptoms at a severity of at least 3, which is a mean of at least mild."|Cycle 1 to Cycle 6|all enrolled participants were analyzed||days||Standard Deviation|Mean
132230|NCT00536198|Primary|Number of Days Pills Were Taken|The number of days that pills were taken on.|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed||number of days||Standard Deviation|Mean
132231|NCT00536198|Other Pre-specified|Adverse Events|A measurement of frequency of adverse events by random assignment|Baseline through Cycle 6|all enrolled participants were analyzed||participants|||Number
132232|NCT00536198|Secondary|Clinical Global Severity (CGI-S)|Clinical Global Impressions-Severity is measured on a scale of 1-7, with 7 as most severe.|Baseline through Cycle 6|all participants enrolled analyzed||units on a scale||Standard Deviation|Mean
132233|NCT00536198|Primary|Michelson SSRI Withdrawal Checklist|Michelson SSRI Withdrawal Checklist - 16-item (not exactly 17-item, mood swings and crying were in DRSP) including dizziness, nausea, unusual dreams, chills, increased sweating, loose stools, agitation, ringing or noises in the ears. Items were summed for 3 days after pill-taking ended for each menstrual cycle.Scale is 0-80 for total range of the scale with lower less severe. There are no units|Measured from Cycle 1 to Cycle 6|all participants enrolled were analyzed||Michelson SSRI withdrawal scale units||Standard Deviation|Mean
132234|NCT00536198|Primary|Inventory of Depression Symptoms (IDS-C)|Inventory of Depressive Symptomatology-Clinician version (IDS-C) - a depression measure that has 28 items and detects appropriate variations between follicular and luteal phases in subjects with PMDD. Min score is 0, max is 84.Lower score is less symptomatic.|Measured from baseline to Cycle 6|all participants enrolled were analyzed||units on a scale||Standard Deviation|Mean
132235|NCT00536198|Primary|Premenstrual Tension Scale (PMTS)|The PMTS is a 10-item scale constructed to study premenstrual syndromes. It is sensitive to change with treatment. It includes items of irritability-hostility, tension, efficiency, dysphoria, motor coordination, mental-cognitive functioning, eating habits, social impairment, sex drive, and physical symptoms. PMTS-O or PMTS-SR? Min=0 (asymptomatic), Max=40 (Highly symptomatic), higher scores indicate most severe problems|Measured from baseline to Cycle 6|all randomized participants||units on a scale||Standard Deviation|Mean
132236|NCT00536172|Secondary|Depressive Symptoms as Assessed by the Quick Inventory of Depressive Symptomatology-Clinician Rated 16 (QIDS-C-16)|Clinician-rated measure of a patient's depressive symptoms|Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28||||||
132237|NCT00536172|Primary|Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)|Number of participants reaching pre-defined threshold on the QIDS-SR-16 of >/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression.|Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28|Evaluable subjects||participants|||Number
132238|NCT00536120|Secondary|Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6|Alpha4-integrin expression is the mean fluorescent intensity (MFI), a measure of fluorescence intensity often used to monitor changes in surface antigen modulation in flow cytometry. There is no reference range for this test, which was developed at Biogen Idec.|Month 0 (Baseline), Month 3, and Month 6|Participants who had received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.||mean fluorescent intensity (MFI)||Standard Deviation|Mean
132239|NCT00536120|Secondary|Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6|Measurement of the degree of natalizumab saturation of the alpha4 integrin on peripheral blood mononuclear cells was accomplished by staining cells with phycoerythrin conjugated anti human IgG4 antibody (hIgG4-PE) to label the cell-bound natalizumab, followed by flow cytometric detection and quantification.|Month 0 (Baseline), Month 3, and Month 6|Participants who received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.||percent saturation||Standard Deviation|Mean
132240|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 6|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.||percent change||Standard Deviation|Mean
132241|NCT00536120|Secondary|Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy|The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).|Month 0 (Baseline), Month 3|Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.||percent change||Standard Deviation|Mean
132242|NCT00536120|Primary|Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination|Tetanus responders were defined as participants who had at least a 2-fold increase over pre-immunization levels of anti-tetanus antibodies in their blood at 28 days after they were immunized with tetanus.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28 and a pre-immunization antibody value ≤ 3.5 IU/mL. No imputation methods were used in the primary analyses.||percentage of participants|||Number
132304|NCT00535392|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.||Consecutive doses||Standard Deviation|Mean
132243|NCT00536120|Primary|Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination|KLH responders were defined as those participants who had at least a 2-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.|28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)|Participants with an assessment at Day 28. No imputation methods were used in the primary analyses.||percentage of participants|||Number
132244|NCT00536107|Primary|Number of Patients With Serious Adverse Events (SAEs)||From time consent was given to 28 days after last dose|||participants|||Number
132245|NCT00536107|Primary|Number of Patients With Adverse Event (AE)||From time consent was given to 28 days after last dose of study drug.|Evaluable for Safety population: All patients who recived at least one dose of study drug||Participants|||Number
132246|NCT00535938|Secondary|Concurrent Surgical Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent surgical procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study||Patients|||Number
132247|NCT00535938|Secondary|Concurrent Procedure Resource Utilization Patterns|Resource utilization patterns are assessed in terms of concurrent procedures utilized during the study (up to 1,785 days across all indications) and are grouped by highest level term. (Note: NEC=not elsewhere classified)|Up to 1,785 days|Enrolled Cohort: All patients enrolled in the study||Patients|||Number
132248|NCT00535938|Secondary|"BOTOX® Dose in Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
132249|NCT00535938|Secondary|BOTOX® Dose in Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
132250|NCT00535938|Secondary|BOTOX® Dose in Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
132251|NCT00535938|Secondary|BOTOX® Dose in Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
132252|NCT00535938|Secondary|BOTOX® Dose in Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
132253|NCT00535938|Secondary|BOTOX® Dose in Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
132254|NCT00535938|Secondary|BOTOX® Dose in Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The BOTOX® dose was assessed in this patient population. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Units||Standard Deviation|Mean
132270|NCT00535782|Primary|Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||meters/second||Standard Deviation|Mean
132885|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
132255|NCT00535938|Primary|"Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Other Disorders"|"Other disorders include focal dystonia (involuntary muscular contractions/abnormal postures), headache, pain, tics (sudden, repetitive, nonrhythmic movements/vocalizations), tremors (unintentional, rhythmic muscle movements), and other nonspecified disorders. The SF-12 is 12 questions on various health questions. Health utility is a numerical indicator of a person’s preference for a given health state or health outcome. Health utility is a sub-score ranging from 0(death) to 1(perfect health) calculated from the SF-12 total score based on: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and SV1 is scheduled at the physician’s discretion and was a maximum of 568 days for patients with other disorders."|Baseline, SV1 (up to 568 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
132256|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Facial Nerve Disorder|Facial nerve disorder is a condition causing twitching, weakness or paralysis of the face. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 765 days for patients with facial nerve disorder.|Baseline, SV1 (up to 765 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
132257|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Adult Focal Spasticity|Adult Focal Spasticity is a condition in which muscles are continuously tight or stiff in a certain area. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,562 days for patients with adult focal spasticity.|Baseline, SV1 (up to 1,562 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
132258|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cerebral Palsy|Cerebral Palsy is a disability resulting in muscular incoordination and speech disturbances. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 925 days for patients with cerebral palsy.|Baseline, SV1 (up to 925 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
132259|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Hyperhidrosis|Hyperhidrosis is a condition causing excessive sweating, regardless of temperature or exercise. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 1,273 days for patients with hyperhidrosis.|Baseline, SV1 (up to 1,273 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
132260|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Blepharospasm|Blepharospasm is a condition in which the eyelids blink/close involuntarily. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 542 days for patients with blepharospasm.|Baseline, SV1 (up to 542 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
132261|NCT00535938|Primary|Change From Baseline in the SF-6D Measure Health Utility (Quality of Life) Score Using the SF-12® Questionnaire for Patients With Cervical Dystonia|Cervical dystonia is a condition in which the neck muscles contract involuntarily, causing the head to turn to one side, forward or backward. The SF-12 consists of 12 questions on various health questions. Health utility is a numerical indicator of a person’s preferences for a given health state or health outcome. Health utility is a sub-score ranging from 0 (death) to 1 (perfect health) and is calculated from the SF-12 total score based on the following items: physical functioning, role participation, social functioning, bodily pain, mental health, and vitality and is termed SF-6D. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The length of time between Baseline and Subsequent Visit 1 (SV1) is scheduled at the physician’s discretion and was a maximum of 505 days for patients with cervical dystonia.|Baseline, SV1 (up to 505 days)|Efficacy Cohort: all enrolled patients who had a valid SF-6D score at baseline and at least one valid SF-6D score at a subsequent visit within the prospective period and who had data at this time point||Scores on a Scale||Standard Deviation|Mean
132262|NCT00535873|Primary|Overall Response Rate (ORR)|ORR defined as number of participants with best response of Complete or Partial response out of total number of participants. Response assessed using the NCI Working Group criteria for response following 3 cycles, 6 cycles and yearly thereafter.|From 3 cycles (90 days) up to 6 cycles (approximately 180 days)|||participants|||Number
132263|NCT00535847|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline through Week 48|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||participants|||Number
132264|NCT00535847|Secondary|Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response|Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.|Baseline up to Week 72|The FA set included subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]). Data was presented for overall subjects based on eRVR and SVR status as per planned analysis.||participants|||Number
132265|NCT00535847|Secondary|Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|48 weeks after completion of treatment (up to Week 96)|Analysis population included subjects who completed assigned treatment in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
132266|NCT00535847|Secondary|Percentage of Subjects With End of Treatment Response|Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|End of treatment (up to Week 48)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
132267|NCT00535847|Secondary|Percentage of Prior Relapsers With Undetectable HCV RNA|Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|Analysis population included all enrolled subjects who were prior relapsers in parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) and received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
132268|NCT00535847|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of treatment (up to Week 72)|The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 [NCT00535847]).||percentage of participants||95% Confidence Interval|Number
132269|NCT00535821|Primary|Mortality|In-hospital mortality|hospital|||participants|||Number
132305|NCT00535392|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
132271|NCT00535782|Secondary|Number of Participants Experiencing Adverse Events (AEs)|"A severe AE is an event in which the intensity of the event results in an inability to work or perform normal daily activity.~A Serious AE is fatal, life-threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one of the above outcomes.~AEs of special interest include infection, gastrointestinal, infusion reaction (occurring during or within 24 hours of infusion), hepatic disorder, myocardial infarction and stroke."|Up to Week 24|The safety population includes all patients who received any part of an infusion of study drug and who provided at least one assessment of safety. Randomized patients who received the incorrect therapy from that intended are summarized in the group according to the therapy actually received.||participants|||Number
132272|NCT00535782|Secondary|Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)|Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid–femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||meters/second||Standard Deviation|Mean
132273|NCT00535782|Secondary|Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 24|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||nmol/L||Standard Deviation|Mean
132274|NCT00535782|Primary|Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers|Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.|Baseline and Week 12|Intent to treat (ITT) population. All randomized patients who received any part of an infusion of study medication are included. Patients who received an incorrect therapy from that intended are summarized in the group according to the intended randomized treatment group. Last observation carried forward (LOCF) imputation was used.||nmol/L||Standard Deviation|Mean
132275|NCT00535769|Secondary|Recalled Frequency of Sunscreen Application|The participants were asked to recall their frequency of sunscreen application based on a 5 point scale (0 never used sunscreen,; 1 forgot to apply 3x weekly,; 2 forgot to apply 1-2x weekly; 3 forgot to apply 1-2x per month; 4 always remembered)|6 weeks|All participants were assessed||units on a scale||Standard Deviation|Mean
132276|NCT00535769|Secondary|Usefulness of Text Messaging System|Patients with the text message reminder system were asked their opinion on their satisfaction/ improved adherence to sunscreen application with the use of the messaging system on a scale of 0 to 10 (0, not useful at all; 10,most useful)|6 weeks|Patients with text messaging system included in analysis||units on a scale||Standard Deviation|Mean
132277|NCT00535769|Primary|Number of Days the Subjects Are Adherent to Using Sunscreen|Participants’ adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared.|6 weeks|All participants were analyzed||days||95% Confidence Interval|Mean
132278|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
132279|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
132280|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
132281|NCT00535730|Primary|Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.|GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.||micrograms/mL||95% Confidence Interval|Geometric Mean
132282|NCT00535730|Primary|Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.|"GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23.~gpELISA = glycoprotein enzyme-linked immunosorbent assay."|Four weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
132283|NCT00535730|Secondary|Safety and Tolerability of Both Vaccines When Administered Concomitantly.|All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events.|Eight weeks postvaccination|All subjects who received at least one vaccination||Participants|||Number
132284|NCT00535730|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|"GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.~*gpELISA = glycoprotein enzyme-linked immunosorbent assay"|4 weeks postvaccination|Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.||gpELISA units*/mL||95% Confidence Interval|Geometric Mean
132285|NCT00535652|Primary|Tissue (Total) Concentrations of Ertapenem in the Colorectal Tissue|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue every 30 minutes up to 10 hours|The mean (+- SD) tissuetotal concentrations of ertapenem in the colorectal tissue as an average of every 30 miuntes up to 10 hours|||mg/kg||Standard Deviation|Mean
132286|NCT00535652|Secondary|Safety Assessment||0 to approx. 14 days after admission||||||
132287|NCT00535652|Primary|Concentration of Ertapenem in Colorectal Tissue in mg/kg 3 to 6 Hours After a Single Dose of 1 Gram Ertapenem I.V..||3 to 6 hours after a single dose of 1 gram ertapenem I.V..||||||
132288|NCT00535587|Secondary|Improvement of Fibromyalgia Symptoms||6 months||||||
132289|NCT00535587|Primary|Levels of Growth Hormone Post Exercise|Serum growth hormone at peak V02/treadmill|6 months|ITT||ng/ml||Standard Deviation|Mean
132290|NCT00535496|Primary|Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex|The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 3 minutes after administering sugammadex|The ITT population: all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias; their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed. The 1.0 mg/kg group was not evaluated.||Minutes||95% Confidence Interval|Mean
132291|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)|Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|up to 2 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 1.0 mg/kg were not evaluated for this outcome measure.||Minutes||Standard Deviation|Mean
132292|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.7 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.||Minutes||Standard Deviation|Mean
132301|NCT00535405|Secondary|Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
132302|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12||12 weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
132293|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.8 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 42 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.||Minutes||Standard Deviation|Mean
132294|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Reappearance of T4 Measured by a PNS|Neuromuscular function was monitored by applying repetitive TOF stimulations manually to the ulnar nerve of one forearm every 15 seconds & the number of twitches collected manually at the adductor pollicis muscle with the PNS by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 1.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 5 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 4.0 mg/kg were not evaluated for this outcome measure.||Minutes||Standard Deviation|Mean
132295|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T4 is the fourth twitch after TOF nerve stimulation. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.|Up to 7 minutes after administering sugammadex|The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.||Minutes||Standard Deviation|Mean
132296|NCT00535496|Other Pre-specified|Time From Start of Administration of 1.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 1.0 mg/kg sugammadex are presented where the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 150 minutes after administering sugammadex|The ITT population: randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant was not analyzed as the time of recovery was judged unreliable. The 4.0 mg/kg group was not evaluated.||Minutes||Standard Deviation|Mean
132297|NCT00535496|Primary|Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX|Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds & assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.|Up to 4 minutes after administering sugammadex|The Intent-To-Treat (ITT) population: randomized, received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed.The 1.0 mg/kg group was not evaluated.||Minutes||Standard Deviation|Mean
132298|NCT00535405|Secondary|Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12|Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.|12 Weeks|Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
132299|NCT00535405|Secondary|Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12|Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.|12 Weeks|Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
132300|NCT00535405|Secondary|Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12||12 Weeks|Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent of Patients||Standard Error|Mean
132307|NCT00535301|Secondary|Vaginal Mesh Exposure|Vaginal mesh exposure defined as appearance of mesh, placed during the index surgery, not covered by overlying vaginal epithelium on postoperative pelvic exams subsequent to the first postoperative exam. May be either symptomatic or asymptomatic. This was not differentiated in the statistical analysis.|perioperative|||participants|||Number
132308|NCT00535301|Secondary|Operative Time|Calculated as time from first incision to time of closure of last incision.|perioperative|||minutes||Inter-Quartile Range|Median
132309|NCT00535301|Primary|Recurrent Stage II or Greater Anterior Vaginal Prolapse|Pelvic Organ Prolapse Quantification Point Ba is the most distal position of any part of the anterior vagina between point Aa and the vaginal cuff or anterior vaginal fornix. Better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is –3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). Recurrent stage II or greater anterior vaginal prolapse is defined as POPQ Point Ba measurement equal to or greater (more positive) than -1.|three years|Intention to Treat. Stage II or greater anterior vaginal prolapse was defined as POPQ Ba equal to or greater than -1.||participants|||Number
132310|NCT00535288|Secondary|Change From Baseline in WHQ Vasomotor Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for vasomotor symptoms.||Score on a scale||Standard Deviation|Mean
132311|NCT00535288|Secondary|Change From Baseline in Women's Health Questionnaire (WHQ) Sleep Problems Symptoms Domain Score at Week 12|The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: ‘Yes definitely=1’, ‘Yes sometimes=2’, ‘No not much=3’ and ‘No not at all=4’. Each score is transformed to a value ‘1’ for scores ‘1’ and ‘2’ and to a value ‘0’ for scores ‘3’ and ‘4’. Sleep problems encompass Items 1, 11, and 29 of the 36 total items. The transformed sums of items 1, 11, and 29 were divided by 3 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.|Baseline and Week 12|All participants who received study drug and had valid answers recorded for the WHQ domain for sleep problems.||Score on a scale||Standard Deviation|Mean
132312|NCT00535288|Secondary|Total Number of Remitters by Week|A participant was defined as a (hot flush) remitter for a study week if at most one moderate/severe vasomotor symptom per day on average was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-remitter.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week. An LOCF approach was used.||Participants|||Number
132313|NCT00535288|Secondary|Total Number of Responders by Week|A participant was defined as a (hot flush) responder for a study week if a reduction of at least 50% for average daily frequency of moderate/severe vasomotor symptoms (hot flushes) (Frequency Score A) compared to Baseline was recorded. A study week was taken into account if at least 4 days were completely observed. The last observation was carried forward if there were less than 4 complete days observed. In cases where Week 1 did not have 4 days that were completely observed, the participant was considered a non-responder. An LOCF approach was used.|Up to 12 weeks|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Participants|||Number
132314|NCT00535288|Secondary|Change From Baseline in Average Daily Mild to Severe Composite Symptoms Score (Composite Score B) by Week|Composite Score B was calculated as Severity Score B x Frequency Score B.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Composite score||Standard Deviation|Mean
132315|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Mild to Severe Vasomotor Symptoms (Severity Score B) by Week|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score B was calculated as the number of mild hot flushes + the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of all hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
132316|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Mild to Severe Vasomotor Symptoms (Frequency Score B) by Week|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score B was based on the number of mild hot flushes + the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
132317|NCT00535288|Secondary|Change From Baseline in Average Daily Moderate/Severe Composite Score (Composite Score A) by Week|Composite Score A was calculated as Severity Score A x Frequency Score A.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Composite score||Standard Deviation|Mean
132318|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
132319|NCT00535288|Secondary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) by Week Excluding Weeks 4 and 12|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
132320|NCT00535288|Secondary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) by Week Excluding Weeks 4 and 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Up to Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
132321|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 12|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 12|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
132322|NCT00535288|Primary|Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4|Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity Score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes per week. If no hot flushes were experienced, this was to be recorded as ‘no sensation of heat’. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The ITT population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Severity score||Standard Deviation|Mean
132323|NCT00535288|Primary|Change From Baseline in Average Daily Frequency of Moderate/Severe Vasomotor Symptoms (Frequency Score A) at Week 4|Participants recorded the frequency (number) of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency Score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.|Baseline and Week 4|The Intent-to-Treat (ITT) population, defined as all randomized participants who had at least one pre-baseline and at least one post-baseline average of the number of hot flushes in a week.||Events per day||Standard Deviation|Mean
136667|NCT00501007|Primary|Mirror-tracing Persistence (in Seconds)|Number of seconds participants continued working on a mirror tracing task before giving up.|baseline|All meeting inclusion criteria||seconds||Standard Deviation|Mean
132324|NCT00535262|Primary|Reduction of Depression CGI Score (<= 2)|"HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire~0 participants analyzed due to early termination of study."|8 weeks||||||
132325|NCT00535223|Secondary|Posttraumatic Cognitions Inventory (PTCI)|This 36 item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. Each item is rated between 1 ( Totally Disagree) to 7 ( Totally Agree). The best score would be 36, indicating that the participant totally did not agree with any of the thoughts that have been associated with PTSD. The worse score would be 252, which would indicate that the participant totally agreed with all of the cognitions that have been associated with PTSD|Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment|||units on a scale||Standard Deviation|Mean
132326|NCT00535223|Primary|Clinician Administered PTSD Scale (CAPS)|This is an interview regarding the frequency and intensity of each of the 17 PTSD symptoms found in DSM IV and includes information about the degree to which these symptoms are interfering with functioning. This interview includes that clinician rating the participants responses for both the frequency of each symptom and the intensity of each symptom on a scale of zero to four. A score of 0, best possible score, would indicate that the participant is no longer reporting any of the 17 DSM IV symptoms of PTSD. The worse possible score is 136, this would indicate that a participant was reporting every symptoms of PTSD occurring daily or almost daily and that each symptom is causing the most extreme level of distress.|Pre treatment, Post treatment (16 weeks) and One year post treatment|Pre-tx Post-tx 1-yr F.U. N M SD Range N M SD Range N M SD Range GBET 41 82.44 15.09 55-107 41 71.73 20.55 34-105 35 69.29 20.71 24-107 PCGT 40 81.18 14.31 52-109 40 75.43 23.01 18-122 33 71.03 22.80 37-121||units on a scale||Standard Deviation|Mean
132327|NCT00535145|Primary|The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER|Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.|Day 1 - Day 62|Safety Analysis Set||Participants|||Number
132328|NCT00535145|Secondary|Personal and Social Performance Score (PSP) Change From Baseline|The PSP (range 1-100) is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Day 1 - Day 62|Includes participants in the efficacy analysis set for with PSP scores available.||Scores on a scale||Standard Deviation|Mean
132329|NCT00535145|Secondary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|The CGI-S (range 1-7) is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness.|Day 1 - Day 62|Efficacy Analysis Set||Scores on a scale||Standard Deviation|Mean
132330|NCT00535145|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline|"The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale (1=Absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate/Severe, 6=Severe, 7=Extreme).The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia."|Day 1 - Day 62|Efficacy Analysis Set||Scores on a scale||Standard Deviation|Mean
132331|NCT00535132|Secondary|Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint|The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132332|NCT00535132|Secondary|Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint|The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132333|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Scores on a scale||Standard Deviation|Mean
132399|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score|The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132334|NCT00535132|Secondary|Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint|The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Scores on a scale||Standard Deviation|Mean
132335|NCT00535132|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint|The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states “taking all things into account, how satisfied or dissatisfied are you with this medication?” and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132336|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
132337|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 6|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
132338|NCT00535132|Other Pre-specified|Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Worst value is 7 and best value is 1."|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132339|NCT00535132|Other Pre-specified|Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint|The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.|Change from Baseline to Week 6 LOCF|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132340|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 4|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
132341|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Week 2|Intent-to-Treat Population with non-missing values at this timepoint||Participants|||Number
132342|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132343|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 4|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132344|NCT00535132|Secondary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 2|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132494|NCT00533897|Secondary|RI Period; Mean Temperature (T) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||degrees Celsius||Standard Deviation|Mean
132345|NCT00535132|Primary|Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.|The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).|Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)|Intent-to-Treat Population with non-missing values at this timepoint||Points on a scale||Standard Deviation|Mean
132346|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 24 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Participants|||Number
132347|NCT00534976|Secondary|Number of Participants Requiring Rescue Medication at 2 Hours Postdose|This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication.|0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||participants|||Number
132348|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose|This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication.|0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Minutes||Standard Deviation|Mean
132349|NCT00534976|Secondary|Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose|"This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time.~Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins.~The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication."|0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Minutes||Standard Deviation|Mean
132350|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||percent fall * minute||Standard Deviation|Mean
132351|NCT00534976|Secondary|Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose|AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.|Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||percent fall * minute||Standard Deviation|Mean
132366|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks|Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants|||Number
136866|NCT00498368|Secondary|Biochemical Marker IgA at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.||mg/ml||Standard Deviation|Mean
132352|NCT00534976|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||percent fall in FEV1||Standard Deviation|Mean
132353|NCT00534976|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose|Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.|Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose|The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods.||Percent fall in FEV1||Standard Deviation|Mean
132354|NCT00534937|Secondary|Time to Healing of the Venous Stasis Ulcer|Only 2 time points so no calculation details are necessary. The change is calculated as the later time point minus the earlier time point (e.g., 12 weeks minus baseline).|Baseline to 12 weeks|Time to healing can only evaluate the patients that showed healing during the 12 week study therefore the number may not be consistent with other numbers.||days||Standard Deviation|Mean
132355|NCT00534937|Secondary|Percentage Change in Volume of the Affected Limb (-Reduction; +Increase)||12 weeks|Number of participants who completed 12 weeks of treatment without healing. Also limb volume measures must have been present.||percentage of change||Standard Deviation|Mean
132356|NCT00534937|Secondary|Change in Wound Surface Area for Non Healed Subject at 12 Weeks.|Change in wound surface area in cm2 from the initial screening to week 12 for all subject who did not completely healed before or at the 12 week visit.|12 weeks|The participants are those that didn't achieve complete wound healing after 12 weeks of treatment. The change from screening to week 12 in wound surface area is reported.||cm2||Standard Deviation|Mean
132357|NCT00534937|Primary|Complete Healing Rate of Venous Stasis Ulcers|Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.|12 weeks|||participants|||Number
132358|NCT00534833|Secondary|Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.||Participants|||Number
132359|NCT00534833|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination|Day 28 post-vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.||Titers||95% Confidence Interval|Geometric Mean
132360|NCT00534833|Primary|Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria.~Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio."|28 Days post-vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.||Participants|||Number
132361|NCT00534794|Secondary|Ocular Comfort Score at 12 Hours|Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.|12 hours|||units on a scale||Standard Deviation|Mean
132362|NCT00534794|Primary|Change in Ocular Itch Score From Baseline|Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.|0 hours, 12 hours|||units on a scale||Standard Deviation|Mean
132363|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 14|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 14 (21-day cycle)|Zero participants were analyzed.|||||
132364|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 7|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 7 (21-day cycle)|Zero participants were analyzed.|||||
132365|NCT00533702|Secondary|Maximum Concentration (Cmax) for Cycle 1 Day 1|Cmax was not calculated due to sparse sampling.|Cycle 1 Day 1 (21-day cycle) 1-hour post infusion|Zero participants were analyzed.|||||
132886|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
132367|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|12 weeks (4 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants|||Number
132368|NCT00533702|Secondary|Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks|Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.|6 weeks (2 cycles of treatment)|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants|||Number
132369|NCT00533702|Secondary|Duration of Response|The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug and who had CR or PR. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=2; IMC-1121B (ramucirumab)=0.||months||95% Confidence Interval|Median
132370|NCT00533702|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.|Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug.||percentage of participants||95% Confidence Interval|Number
132371|NCT00533702|Secondary|Number of Participants With Adverse Events (AE)|The number of participants who experienced any IMC-1121B (ramucirumab [RAM]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 40 months|Safety Population: All enrolled participants who were treated with any quantity of study drug.||participants|||Number
132372|NCT00533702|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.|Baseline up to 36 months|Intent-to-Treat Population: All enrolled participants who were treated with any quantity of study drug. Censored participants: IMC-1121B (ramucirumab) + dacarbazine=9; IMC-1121B (ramucirumab)=4.||months||95% Confidence Interval|Median
132373|NCT00534638|Secondary|Number of Male Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in All Male Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from dose1-Day 0 to Visit 5-18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
132374|NCT00534638|Secondary|Number of Female Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in a Female Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Dose 1-Day 0 to Visit 5-18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available||Subjects|||Number
132375|NCT00534638|Secondary|Number of Female Subjects With New Onset of Autoimmune Diseases (NOADs).|NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.|Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
132376|NCT00534638|Secondary|Number of Subjects Reporting Pregnancies With Onset During the Study|Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy. One additional pregnant subject was lost to follow-up during the study.|Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)|The analysis was based on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which all vaccinated subjects for whom data were available.||Subjects|||Number
132377|NCT00534638|Secondary|Titres for Anti-HPV-16 and Anti-HPV-18 Antibodies, by Gender, in a Subset of Subjects.|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.|At the time of visits 1 and 4 (at Day 0 and Month 7) and at the time of Visit 5 (18.5 years of age)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.||Titres||95% Confidence Interval|Geometric Mean
132378|NCT00534638|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects.|The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.|At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.||Subjects|||Number
132379|NCT00534638|Secondary|Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to the Visit 5 (18.5 years of age)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
132380|NCT00534638|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Dose 1 (at Day 0) until Month 12|The analysis was based on the Total Vaccinated Cohort subset of Male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B Group male subjects.||Number|||Number
132381|NCT00534638|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects.|MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|From Dose 1 (at Day 0) until Month 12|The analysis was performed on the Total Vaccinated Cohort - Diary Card subset - a subset of male adolescents from the Cervarix/Engerix-B and Engerix-B Groups, selected for active assessment of safety using diary cards.||Subjects|||Number
132382|NCT00534638|Secondary|Number of Subjects Reporting Rash and Urticaria, in a Subset of Subjects.||Within 30 minutes following vaccination|This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.||Subjects|||Number
132383|NCT00534638|Secondary|Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after any vaccination|This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.||Subjects|||Number
132384|NCT00534638|Secondary|Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0 - 6) after any vaccination|The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.||Subjects|||Number
132432|NCT00534352|Primary|Number of Participants Contributing to the Pharmacokinetic (PK) Evaluations: Cmin, Cmax, AUC24 & Css,av|At visit Days 14 & 28, samples were collected pre-dose and at 1, 2, 3, 4, 6, 9, and 12 hours post-dose. An additional sample was taken at 24 hours (Day 15 or 29 as applicable) post-dose.|6 weeks|Intention To Treat (ITT) population||participants|||Number
132385|NCT00534638|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0 - 6) after any vaccination|The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.||Subjects|||Number
132386|NCT00534638|Secondary|Number of Female Subjects With Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Serotypes|The analysis of total effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in HPV vaccinated subjects from the investigated group (prevalence rate in HPV vaccinated subjects from the investigated arm/prevalence rate in all subjects from Arm C).|At the time of visit 5 (at 18.5 years of age)|The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.||Subjects|||Number
132387|NCT00534638|Primary|Number of Female Subjects With Vaccine Overall Effectiveness Against Genital Infection With Human Papilloma Virus (HPV) 16/18 Serotypes|The analysis of overall effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated arm/prevalence rate in all subjects from Arm C).|At the time of visit 5 (at 18.5 years of age)|The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.||Subjects|||Number
132388|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||Participants|||Number
132389|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in CGI-S Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132390|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132391|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score|Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132392|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132393|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Mean change from randomization||Standard Deviation|Mean
132394|NCT00534599|Secondary|Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score|Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Mean change from randomization||Standard Deviation|Mean
132395|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score|"The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer.~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132396|NCT00534599|Secondary|Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Participants|||Number
132397|NCT00534599|Secondary|Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8|Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.|Baseline (randomization) and then 8 weeks|||Participants|||Number
132398|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score|"The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132464|NCT00534209|Primary|Progression-free Survival (Phase II)||Date of randomization to the earliest date of documented progression.||||||
132400|NCT00534599|Secondary|"Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8"|"This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'.~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||Participants|||Number
132401|NCT00534599|Secondary|Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score|"The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1).~Results based on MITT population with available data for this outcome measure."|Baseline (randomization) and then 8 weeks|||LS mean change from randomization||95% Confidence Interval|Least Squares Mean
132402|NCT00534599|Primary|Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value."|Baseline (randomization) and then 8 weeks|Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized.||units on scale||95% Confidence Interval|Least Squares Mean
132403|NCT00534495|Primary|Number of Serious Adverse Events,Adverse Events, Infections, Development of MAS||At Weeks 0- 24|||events|||Number
132404|NCT00534495|Secondary|Number of Participants With Presence of Systemic Features ( Fever, Rash)||At Weeks 4, 12 and 24|At week 4 ,Rilonacept 36 and Placebo 34 participants , at week 12 , Rilonacept 33 and 29 Placebo participants , and at week 24 combined group with 57 participants, at baseline Rilonacept 36 and Placebo 35 participants.||participants|||Number
132405|NCT00534495|Secondary|Physical Function as Determined by Childhood Health Assessment Questionnaire ( CHAQ)|"Childhood Health Assesment Questionairre dissability index (C-HAQ)-DI, Disability Index Calculation:~The index is calculated by adding the scores for each of the categories and dividing by the number of categories answered. This gives a score in the 0 to 3.0 range. lower is better"|At Weeks 12 and 24|36 Rilonacept and 35 placebo at baseline , 36 Rilonacept and 34 placebo at week 4, 33 Rilonacept and 29 placebo at week 12, and 57 combined at week 24.||units on a scale||Inter-Quartile Range|Median
132406|NCT00534495|Secondary|Pediatric Quality of Life Inventory|Visual Analog Score (0-100 mm) 0 very well , 100 very poor|At Weeks 4, 12 and 24|At Week 4 ,36 Rilonacept and 34 Placebo patient. At week 12, Rilonacept 33 patients and Placebo 29.At baseline Rilonacept 36 and Placebo 35 participants.||units on a scale||Inter-Quartile Range|Median
132407|NCT00534495|Secondary|Number of Participants With Response as Determined by JIA ACR50 and JIA ACR70||At Week 4 and week 12|Participants in the study at week 4 (rilonacept 35 and placebo 33).Participants in the study at week 12 ( Rilonacept 33 and placebo 29).||participants|||Number
132408|NCT00534495|Primary|Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are Taking Corticosteroids||At Week 12|||weeks||Inter-Quartile Range|Median
132409|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Functioning)|The subject rates each question about physical functioning on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available. Note that 4 items only had data available from 27 participants rather than 28.||percentage of participants|||Number
132410|NCT00534417|Post-Hoc|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death from any cause, up to 32.5 months.|14 patients had died, and 27 patients were censored in the OS analysis.||Months||95% Confidence Interval|Median
132411|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Psychiatric Symptoms)|The subject rates each question about psychiatric symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.||percentage of participants|||Number
132412|NCT00534417|Secondary|Patients Experiencing Severe Symptom Burden (Physical Symptoms)|The subject rates each question about physical symptoms on a scale of 0 through 10, where 0 is not bad and 10 is as bad as possible. Severe symptoms are indicated by a response > or = to 7 on an item.|The questionnaire was administered on day 1 of every cycle (approximately every 4 weeks) during study treatment.|Participants who had questionnaire data available.||percentage of participants|||Number
132413|NCT00534417|Primary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, up to 32.5 months.|21 patients had experienced disease progression, and three had died. 17 patients were censored in PFS analysis.||Months||95% Confidence Interval|Median
132414|NCT00534417|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after every 8 weeks of treatment|||percentage of participants||95% Confidence Interval|Number
133857|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
132415|NCT00534417|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants experiencing complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment|||percentage of participants||95% Confidence Interval|Number
132416|NCT00534417|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment|||participants|||Number
132417|NCT00534417|Primary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per Response Evaluation Criteria in Solid Tumors (RECIST)v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), up to 29 months.|21 patients had experienced disease progression. 20 patients were censored in TTP analysis. The 3 deaths in the PFS analysis were censored for the TTP analysis.||Months||95% Confidence Interval|Median
132418|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 3-month Follow up||3-months post randomization|||participants|||Number
132419|NCT00534404|Secondary|Self-reported 30-day Prolonged Abstinence at 9-month Follow up||9 months post randomization|||participants|||Number
132420|NCT00534404|Primary|Self-reported 6-month Prolonged Abstinence From Smoking|Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.|Measured at 9 Months post-randomization|All currently enrolled participants were invited via email to complete an online follow-up survey. Participants who did not respond to the email received phone calls from study staff asking them to complete the survey online. Results to this outcome measure are from those subjects who completed the survey.||participants|||Number
132421|NCT00534352|Secondary|CD4+ Cell Count (Percent): Baseline and Median Changes From Baseline (ITT-Observed Case)||Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)||Percent Change from Baseline||Full Range|Median
132422|NCT00534352|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case)|CD4+ Cell Count (x 10^6 cell/L): Baseline and Median Changes From Baseline (ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 ans Week 48|||x 10^6 cell/L||Full Range|Median
132423|NCT00534352|Secondary|Log10 Viral Load (HIV-1 RNA Copies/mL): Mean Changes From Baseline(ITT-Observed Case)|Log10 Viral Load (HIV-1 RNA copies/mL): Mean Changes From Baseline(ITT-Observed Case).|Baseline, Day 8, 14, 22, 28 & 42 and Week 48|ITT (Observed)||copies/mL||Standard Error|Mean
132424|NCT00534352|Secondary|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case)|Virologic Response < 50 HIV-1 RNA Copies/mL (ITT-Observed Case).|Day 8, 14, 22, 28, 42 and Week 48|ITT||participants|||Number
132425|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Triglycerides.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 48 and Week 48|ITT||participants|||Number
132426|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density Lipoprotein (LDL) Direct|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities(Worst Grade): Lipids- Low-density lipoprotein (LDL) Direct.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
132427|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density Lipoprotein (HDL)|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Lipids- High-density lipoprotein (HDL).~Normal Range:~40 - 59 mG/dL 1.03 - 1.53 mmol/L"|Day 1 through 42 and Week 48|ITT||participants|||Number
132428|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Lipids- Total Cholesteral.~Worst Grade is based on the DAIDS toxicity grading scale, 0-5 : No Toxicity-Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
132429|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin|"Number of participants with Treatment-Emergent Non-Graded Laboratory Abnormalities(Worst Abnormality): Glucose- Insulin.~Normal Range: 3.0 - 27.0 ulU/mL"|Day 1 through 42 and Week 48|||participant|||Number
132430|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia|"Number of participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose- Hypoglycemia.~Worst Grade is based on the DAIDS toxicity grading scale 0-5: No Toxicity-Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
132431|NCT00534352|Secondary|Number of Participants With Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia|"Number of Participants with Treatment-Emergent Graded Laboratory Abnormalities (Worst Grade): Glucose-Hyperglycemia.~Worst Grade is based on the National Institute of Allergy and Infectious Diseases Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity grading scale, 0,1,2,3,4 and 5 : None, Mild, Moderate, Severe, Life-threatening and Death."|Day 1 through 42 and Week 48|ITT||participants|||Number
132433|NCT00534313|Secondary|Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169|The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication at any time. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
132434|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized participants who received treatment and with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.||Units on a scale||Standard Error|Mean
132435|NCT00534313|Secondary|Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters|PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.|Days 1, 15, 29, 57, 85, 113, 141, and 169||||||
132436|NCT00534313|Secondary|Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept|Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.||µg/mL||Full Range|Geometric Mean
132437|NCT00534313|Secondary|Short-term Period: Mean Serum Concentrations of Abatacept|Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.|Days 1, 15, 29, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively.||µg/mL||Standard Deviation|Mean
132438|NCT00534313|Secondary|Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169|PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Day 169 from Baseline|All randomized and treated participants with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations.||Units on a scale||Standard Error|Mean
132439|NCT00534313|Secondary|Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)|Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].|From Baseline to Day 169|Participants who received abatacept and for whom baseline and at least 1 additional measurement were available during the double-blind (short-term) period.||Participants|||Number
132440|NCT00534313|Secondary|Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169|Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study drug in double-blind (short-term) period. Only participants with both baseline and postbaseline values included. Missing values at Day 169 were imputed using the last observation carried forward values, except for participants with only baseline value.||Percentage of change||Standard Error|Mean
132441|NCT00534313|Secondary|Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169|Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
132465|NCT00534209|Primary|Preliminary Safety Profile (Phase I)|This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.|12 weeks|||participants|||Number
132466|NCT00534105|Secondary|LDL|LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum|||mg/dl||Inter-Quartile Range|Mean
132442|NCT00534313|Secondary|Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period.||Participants|||Number
132443|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis|Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n = number of participants with evaluable results (each arm respectively).||Participants|||Number
132444|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results.||Participants|||Number
132445|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
132446|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry|ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.|Baseline to Day 169|All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
132447|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
132448|NCT00534313|Primary|Short-term Period: Number of Participants With ACR 20 Response at Day 169|An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant’s assessment of disease activity, participant’s global assessment of disease activity, investigator’s global assessment of disease activity, participant’s assessment of physical function by HAQ–DI, and Disease Activity Score 28-C reactive protein.|At Day 169 from Baseline|All randomized participants who received at least 1 infusion of study medication in the double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
132449|NCT00534313|Secondary|Short-term Period: Number of Participants With Marked Abnormalities in Hematology|LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.|From Baseline to Day 169|All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively).||Participants|||Number
132450|NCT00534313|Secondary|Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729|Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.|Days 365 and 729 from baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with responses available)||Participants|||Number
132467|NCT00534105|Secondary|HDL|Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.|Postpartum|||mg/dl||Inter-Quartile Range|Mean
132451|NCT00534313|Secondary|Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729|PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|At Days 365 and 729 from baseline|||Units on a scale||Standard Error|Mean
132452|NCT00534313|Secondary|Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729|Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.|From Baseline to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period.||Percentage of change||Standard Deviation|Mean
132453|NCT00534313|Secondary|Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729|IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).|From Day 169 to Days 365 and 729|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)||Participants|||Number
132454|NCT00534313|Secondary|Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729|An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.|At Days 365 and 729 from Baseline|All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response)||Percentage of participants||95% Confidence Interval|Number
132455|NCT00534313|Primary|Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest|Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.|From Day 169 to Day 729|All participants who received at least 1 infusion of abatacept during the long-term period.||Participants|||Number
132456|NCT00534248|Secondary|Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period|"A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing~hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement."|Through 42 days post-vaccination|All participants who were vaccinated according to actual treatment received (Zostavax or placebo) and had safety follow-up.||participants|||Number
132457|NCT00534248|Secondary|Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group|VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.|6 Weeks|Random subcohort population included 10% of all randomized participants randomly selected for immunogenicity assay, were vaccinated (according to actual treatment received), had results at prevaccination and at 6 weeks postvaccination. Results from participants with protocol violations that may impact the immunogenicity analysis were excluded.||gpELISA units/mL||95% Confidence Interval|Mean
132458|NCT00534248|Primary|Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group|Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.|2 Years|Intent-to-treat population defined as all participants randomized in the study according to the planned treatment, Zostavax or placebo, they were assigned.||number of HZ cases/1000 person-years||95% Confidence Interval|Mean
132459|NCT00534209|Secondary|Overall Survival (Phase II)||Date of randomization to the recorded date of death||||||
132460|NCT00534209|Secondary|Response to Second-line Chemotherapy After Disease Progression (Phase II)||TThe percentage of patients experiencing a clinical response (CR, PR, SD) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls.||||||
132461|NCT00534209|Secondary|Safety Profile (Phase II)||The number of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.||||||
132462|NCT00534209|Secondary|The Adaptive Immune Response||Reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses.||||||
132463|NCT00534209|Secondary|Clinical Outcomes (Phase I)||Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact).||||||
132471|NCT00534092|Other Pre-specified|Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study|The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other.|3+ years following first 2 years post-X-STOP implant through IDE study|||participants|||Number
132472|NCT00534092|Secondary|Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years)|Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 “worst” to 100 “best. The change from baseline to the 5 year postoperative visit for each of these domains is presented.|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study|||units on a scale||Standard Deviation|Mean
132473|NCT00534092|Secondary|Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction.|3+ years following first 2 years post-X-STOP implant through IDE study|||units on a scale||Standard Deviation|Mean
132474|NCT00534092|Secondary|Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score.|Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study|||units on a scale||Standard Deviation|Mean
132475|NCT00534092|Primary|Treatment Success Rates (At ≥ 5 Years)|Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success.|3+ years following first 2 years post-X-STOP implant through IDE study|Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort.||percentage of participants|||Number
132476|NCT00533897|Secondary|LTE: Mean Temperature (T) During LTE|During LTE, temperature was taken in participants while seated, measured in degrees celsius and was assessed at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||degrees Celsius||Standard Deviation|Mean
132477|NCT00533897|Secondary|LTE: Mean Heart Rate (HR) During LTE|During LTE, heart rate was taken in participants while seated, measured in beats per minute (bpm) and was assessed at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||bpm||Standard Deviation|Mean
132478|NCT00533897|Secondary|LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mmHg||Standard Deviation|Mean
132479|NCT00533897|Secondary|LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE|During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mm Hg||Standard Deviation|Mean
132493|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ELISA.|Day 197 through Day 253|Participants treated during the RI Period with at least 1 immunogenicity result (ELISA) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point||ug/mL||Standard Deviation|Mean
132480|NCT00533897|Secondary|LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the LTE period.||participants|||Number
132481|NCT00533897|Secondary|LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.||participants|||Number
132482|NCT00533897|Secondary|LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.||participants|||Number
132483|NCT00533897|Secondary|LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period and who had data available during the LTE period.||participants|||Number
132484|NCT00533897|Secondary|LTE: Number of Participants With AEs of Special Interest During LTE|AEs of special interest in LTE are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies, local injection site reaction (pre-specified AEs occurring at the site of SC injection) and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period||participants|||Number
132485|NCT00533897|Secondary|LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. SAEs include hospitalizations for elective surgical procedures.All deaths reported during the LTE including those that occurred > 56 days after the last dose. Related AE or SAE defined as AE or SAE with Certain, Probable, Possible, or Missing relationship to study medication. All participants who completed the ST period could enter the open label LTE on Day 253; LI Period 1 non-responders could directly enter the LTE.|For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.|Participants who received at least 1 dose of study medication in LTE period||participants|||Number
132486|NCT00533897|Secondary|LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using electrochemiluminescence (ECL). The percent of participants with a positive abatacept induced immunogenicity response against cytotoxic T-lymphocyte antigen 4 (CTLA4) and possibly immunoglobulin (Ig), or against Ig and/or Junction Region was calculated by number of participants with a positive response divided by number of participants evaluated. Overall for on-treatment includes treatment visits on Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, and 1989.|Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTE|All participants treated in LTE period with at least 1 immunogenicity result (ECL) during LTE period. n=number of participants evaluated.||percentage of participants|||Number
132487|NCT00533897|Secondary|LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index (DI) was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ DI. Percent=number of participants with HAQ response divided by number of participants in the analysis. Since Period I Non-responders proceeded directly to the LTE at the end of Period I (Day 85), study days do not represent treatment days.|Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were non-responders at the end of Period 1. n= number of participants with data who were evaluated||percentage of participants||95% Confidence Interval|Number
132488|NCT00533897|Secondary|LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE|DAS28:continuous disease measure composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. Low disease activity score: ≤ 3.2. Percent=Number of participants with Low Disease Activity divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1.||percentage of participants|||Number
132489|NCT00533897|Secondary|LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. Clinical remission=DAS28-CRP score<2.6. Percent=Number of participants meeting remission divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available (NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n= number of participants evaluated at each specific timepoint||percentage of participants|||Number
132490|NCT00533897|Secondary|LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE|DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. DAS28-CRP has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant’s Treatment Day 169.|For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.|The LTE Treated Population contained those participants who received at least 1 dose of study medication during the LTE. Participants in LTE either completed Period 3 or were nonresponders at the end of Period 1. n=number of participants with both baseline and post-baseline measurements.||units on a scale||Standard Error|Mean
132491|NCT00533897|Secondary|ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups|Venous blood was collected and tested for anti-nuclear antibodies, anti-dsDNA antibodies, and rheumatoid factor. ANA were detected by means of immunofluorescent antibodies. An anti-DNA radioimmunoassay was used for detection of anti-dsDNA antibodies (Diagnostic Products Corporation). RF was measured by an immunoturbidimetric assay (Roche Tina-Quant). Determinations of antibody or RF status were made at baseline and Day 253.|Baseline, Day 253|Participants treated in DBW period with at least 1 immunogenicity result (immunofluorescence, radioimmunoassay, or immunoturbidimetry) during this period. N=Number of Participants Analyzed, n=number of participants with data for that time point||participants|||Number
132492|NCT00533897|Secondary|Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups|Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ECL.|Day 197 through Day 253|Participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point||ug/mL||Standard Deviation|Mean
132887|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
132495|NCT00533897|Secondary|RI Period; Mean Heart Rate (HR) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||beats per minute (bpm)||Standard Deviation|Mean
132496|NCT00533897|Secondary|RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III||Days 169, 197, 225, and 253|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mm mercury (Hg)||Standard Deviation|Mean
132497|NCT00533897|Secondary|RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
132498|NCT00533897|Secondary|RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
132499|NCT00533897|Secondary|RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
132500|NCT00533897|Secondary|RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the RI period.||participants|||Number
132501|NCT00533897|Secondary|RI; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.||participants|||Number
132502|NCT00533897|Secondary|RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.|Participants who received at least 1 dose of study medication in RI period.||participants|||Number
132503|NCT00533897|Secondary|DBW Period; Mean Temperature (T) During Period II|Participants were seated and temperature taken just prior to study drug injection.|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||degrees Celsius||Standard Deviation|Mean
132504|NCT00533897|Secondary|DBW Period; Mean Heart Rate (HR) During Period 2|Heart Rate was taken in participants while seated, just prior to study drug injection, and measured in beats per minute (bpm)|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||beats per minute (bpm)||Standard Deviation|Mean
132921|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132505|NCT00533897|Secondary|DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period|Blood pressures were taken in participants while seated, just prior to study drug injection, and measured in millimeters of mercury (mmHg).|Days 113, 141, and 169|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point.||mm mercury (Hg)||Standard Deviation|Mean
132506|NCT00533897|Secondary|DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
132507|NCT00533897|Secondary|DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
132508|NCT00533897|Secondary|DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
132509|NCT00533897|Secondary|DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during the DBW period.||participants|||Number
132510|NCT00533897|Secondary|DBW; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period||participants|||Number
132511|NCT00533897|Secondary|DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier|Participants who received at least 1 dose of study medication in DBW period||participants|||Number
132512|NCT00533897|Secondary|LI Period; Mean Temperature (T)|Temperature was taken in participants while seated and measured in degrees celsius. Temperature was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.||degrees Celsius||Standard Deviation|Mean
132560|NCT00533507|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132513|NCT00533897|Secondary|LI Period; Mean Heart Rate (HR)|Heart rate was taken in participants while seated and measured in beats per minute (bpm). Heart rate was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.||bpm||Standard Deviation|Mean
132514|NCT00533897|Secondary|LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was taken in participants while seated and measured in millimeters of mercury (mmHg). Pressures were assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely.|Days 1, 15, 29, 57, 78, and 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available at that time point during the LI period.||mmHg||Standard Deviation|Mean
132515|NCT00533897|Secondary|LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*upper limits of normal (ULN),or if BL< lower limits of normal (LLN) then use 0.8*BL or > upper limits of normal (ULN),or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >ULN,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis: Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells (RBCs), White Blood Cells (WBCs):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed. n (when indicated)= number of participants with data available during LI period.||participants|||Number
132516|NCT00533897|Secondary|LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.||participants|||Number
132517|NCT00533897|Secondary|LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.||participants|||Number
132518|NCT00533897|Secondary|LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/ microliter (uL); eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period.||participants|||Number
132519|NCT00533897|Secondary|LI Period; Number of Participants With AEs of Special Interest|AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period||participants|||Number
132520|NCT00533897|Secondary|LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier|Participants who received at least 1 dose of study medication during LI period||participants|||Number
132857|NCT00530920|Secondary|Volume of Distribution (V/F) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L||Geometric Coefficient of Variation|Geometric Mean
132521|NCT00533897|Secondary|RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 169 (Period III Baseline), 197, 225, and 253|Participants who received at least 1 dose of study medication during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at RI period baseline.||units on a scale||Standard Error|Mean
132522|NCT00533897|Secondary|DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time|"A participant had an RA flare if at least 2 of the following criteria were met:~Doubling of tender and swollen joint count from Day 78~Increase in DAS28-CRP score ≥ 1.2 from Day 78~Prematurely discontinued from Double-blind Withdrawal Period (Period 2) and continued to Re-introduction Period (Period 3)"|Days 85, 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
132523|NCT00533897|Secondary|DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85 (Period 2 Baseline), 113, 141, and 169|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at DBW period baseline.||units on a scale||Standard Error|Mean
132524|NCT00533897|Secondary|LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||percentage of participants|||Number
132525|NCT00533897|Secondary|LI; Mean Change in DAS 28 (CRP) From Baseline Over Time|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline), 15, 29, 57, 78, 85|Participants who received at least 1 dose of study medication during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||units on a scale||Standard Error|Mean
132526|NCT00533897|Secondary|Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||percentage of Participants|||Number
132527|NCT00533897|Secondary|Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||units on a scale||Standard Error|Mean
132528|NCT00533897|Secondary|Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups|DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 85, 169, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and, when relevant, at baseline.||percentage of participants|||Number
132922|NCT00530842|Secondary|Static Lung Volumes|Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132529|NCT00533897|Secondary|Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups|The DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline.|Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)|Intent To Treat Analysis Population (DBW Period, Participants randomized in DBW period who received at least 1 dose of study medication in DBW period). N=Number of Participants Analyzed, n=number of participants with data for that time point and at baseline.||units on a scale||Standard Error|Mean
132530|NCT00533897|Secondary|Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of Participants|||Number
132531|NCT00533897|Secondary|Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups|Serum samples from Abatacept-treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. ST was defined as the LI Period, the DBW Period, and the RI Period (Days 1-253).|For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during the Short Term. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
132532|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ECL) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
132533|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
132534|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits|||||
132535|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ECL) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
132536|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 22 after last dose of drug to Day 85 after last dose of drug|These data were not summarized since there were no participants at any post visits.|||||
132537|NCT00533897|Primary|Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated in RI period with at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
132538|NCT00533897|Secondary|DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Samples were obtained during treatment (TRT) visits.|Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period|All participants treated in DBW period with at least 1 immunogenicity result (ELISA) during DBW period. N=Number of Participants Analyzed, n=number of participants with data for that time point.||percentage of participants|||Number
132539|NCT00533897|Secondary|LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time|ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in Period 1 (Lead-in Period). N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
132540|NCT00533897|Secondary|Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug|All participants treated in LI Period who had at least 1 immunogenicity result (ELISA) during LI period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
132541|NCT00533897|Secondary|RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group|Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 253 (short term)|Participants treated with Placebo in DBW period who were treated in RI period and had at least 1 immunogenicity result (ELISA) during RI period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
132542|NCT00533897|Primary|Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Day 169|Participants treated in the DBW Period with at least 1 immunogenicity result (ELISA) during DBW Period. N=Number of Participants Analyzed, n=number of participants with data for that time point||percentage of participants|||Number
132543|NCT00533546|Secondary|National Institutes of Health Stroke Scale (NIHSS)|"The NIHSS is a measure of neurologic deficit on a scale of 0-42, with 0 being normal. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. The 11 items are:~Level of Consciousness Horizontal Eye Movement Visual field test Facial Palsy Motor Arm Motor Leg Limb Ataxia Sensory Language Speech Extinction and Inattention"|90 days|||units on a scale||Standard Deviation|Mean
132544|NCT00533546|Secondary|Mean Barthel Index Score|"Measure of functional recovery using Barthel Index (range 0-100). The Barthel scale or Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility with 10 points given to each variable for a total of 100 points. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The ten variables addressed in the Barthel scale are:~presence or absence of fecal incontinence presence or absence of urinary incontinence help needed with grooming help needed with toilet use help needed with feeding help needed with transfers (e.g. from chair to bed) help needed with walking help needed with dressing help needed with climbing stairs and help needed with bathing"|90 days|||units on a scale||Standard Deviation|Mean
132561|NCT00533507|Primary|Concentration of Anti-Protein D Antibodies|Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||EL.U/mL||95% Confidence Interval|Geometric Mean
132858|NCT00530920|Secondary|Maximum Concentration (Cmax) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
132545|NCT00533546|Secondary|Mean Modified Rankin Scale Score|"Measure of disability as determined by categorical assignment on modified Rankin Scale.. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.~The scale runs from 0-6, running from perfect health without symptoms to death.~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead."|90 days|||units on a scale||Standard Deviation|Mean
132546|NCT00533546|Primary|Number of Participants With Intracranial Hemorrhage|"Intracranial Hemorrhage (ICH):~Fatal ICH: Death ascribed to ICH confirmed by autopsy or CT imaging. Major non-fatal ICH: Hemorrhage within brain parenchyma associated with neurological deterioration or evidence of subdural, epidural or intraventricular hemorrhage on CT imaging, with or without symptoms.~Symptomatic ICH: Hemorrhage within the territory of qualifying infarction with neurological deterioration as measured by > 2 point increase in the National Institutes of Health Stroke Scale (NIHSS) from previous examination; hemorrhage in different vascular territory associated with new neurologic deficit. All symptomatic ICH will be defined as a major ICH.~Asymptomatic ICH: Presence of hemorrhage within the territory of qualifying infarction without neurological deterioration ascribed to the hemorrhage or presence of hemorrhage within brain parenchyma outside the territory of qualifying infarction without new neurologic deficit (would not be considered a major ICH)"|Measured within 36-48 hours of treatment|All participants enrolled were analyzed.||participants|||Number
132547|NCT00533507|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to one month after the third dose|||subjects|||Number
132548|NCT00533507|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 31-day (Day 0-30) period after each dose|||subjects|||Number
132549|NCT00533507|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting|During the 4-day (Day 0-3) period after each dose|||subjects|||Number
132550|NCT00533507|Secondary|Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value|Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).|Four months after the administration of the second dose of Rotarix™ vaccine|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132551|NCT00533507|Secondary|Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value|Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132552|NCT00533507|Primary|Concentration of Anti-Pneumococcal Antibodies|"Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||µg/mL||95% Confidence Interval|Geometric Mean
132553|NCT00533507|Secondary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132554|NCT00533507|Secondary|Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value|Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132555|NCT00533507|Secondary|Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value|Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132556|NCT00533507|Secondary|Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132557|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132558|NCT00533507|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value|Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132559|NCT00533507|Secondary|Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value|Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).|One month after the third dose|Analysis was performed on ATP cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132562|NCT00533507|Secondary|Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value|Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).|Before the first dose (pre) and one month after (post) the third dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
132563|NCT00533351|Primary|Change From Baseline in Daily Pain Score at Week 2|Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed|||||
132564|NCT00533351|Secondary|Change From Baseline in Subject Global Impression of Change Score at Week 2|Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.|Baseline, Week 2|Due to low number of patients completing the treatment period of the study no analyses were performed.|||||
132565|NCT00533273|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint||||||
132566|NCT00533273|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint||||||
132567|NCT00533273|Secondary|Clinical Improvement After the First Injection||30 days after first treatment to the primary joint||||||
132568|NCT00533273|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint||||||
132569|NCT00533273|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint||||||
132570|NCT00533273|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint||||||
132571|NCT00533273|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint||||||
132572|NCT00533273|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment to the primary joint||||||
132573|NCT00533273|Primary|Reduction in Contracture to 5° or Less of the Primary Joint|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 45 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.~The Primary Outcome Measure for placebo treated patients is the percentage of 21 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|Intent-to-Treat population||% Joints|||Number
132574|NCT00532948|Secondary|Anti Tumor Activity|Tumor response refers to the best response prior to failure (disease progression, death or second malignancy).|Up to 6 years|Efficacy data of the present study (NO18517 - NCT00532948) were pre-specified to be combined with efficacy data of the Phase 2 portion of this Study, NO21125 (NCT01118377) for analysis. Results are currently posted in the record of Study NO21125.|||||
132575|NCT00532948|Secondary|The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5’-DFCR, 5’-DFUR, 5-FU and FBAL)|AUC last concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||h*ng/mL||Standard Deviation|Mean
132576|NCT00532948|Secondary|Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5’-DFCR, 5’-DFUR, 5-FU and FBAL)|Tmax is the corresponding time at which Cmax occurs of capecitabine and its metabolites.Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||Hour||Full Range|Median
132577|NCT00532948|Secondary|Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5’-Deoxy-5-Fluorocytidine [5’-DFCR], 5’-Deoxy-5-Fluorouridine [5’-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL])|The maximum observed plasma concentration of capecitabine and its metabolites. Participants who consented to participating in the PK studies were randomized to either sampling series A or Series B. The collection time points included 2 different series, Series A (Baseline [pre-dose], 10 mins, 30 mins, 1, 2.5, 6, 8 and 10 hours after dosing) and Series B (Baseline [pre-dose], 15 minutes, 45 minutes, 1.5, 4, 8 and 10 hours after dosing).|Day 1 and Day 14|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||ng/mL||Standard Deviation|Mean
132578|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters|For blood chemistry, the parameters assessed were: Sodium, potassium, calcium, magnesium, chloride, bicarbonate, total protein, albumin, alkaline phosphatase, alanine transaminase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), Lactate dehydrogenase (LDH), total bilirubin, direct bilirubin, indirect bilirubin, creatinine (serum creatinine or creatinine clearance), glucose.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||Participants|||Number
132859|NCT00530920|Secondary|Trough Concentration (Cmin) of Tipranavir|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
132579|NCT00532948|Primary|Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters|For hematology, the parameters assessed were: Hemoglobin, hematocrit, platelet count, RBC, WBC, lymphocytes, monocytes,granulocytes (blasts), neutrophils(segs, bands),eosinophils and basophils.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine. Participants available at a particular time point were included in analysis.||Participants|||Number
132580|NCT00532948|Primary|Number of Participants With Adverse Events (AE)|An AE is an unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was monitored and graded according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Adverse events that were not included in the CTCAEv3.0 were reported and graded under the other AE within the appropriate category.|Up to 06 years|The safety population consisted of all eligible patients who received at least one dose of capecitabine.||Participants|||Number
132581|NCT00532948|Primary|Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the 11 week dose-finding period: any event that leads to interruption of planned radiation for 5 consecutive days or 10 days total; Grade 4 neutropenia or thrombocytopenia; Grade 3 thrombocytopenia that required a platelet transfusion on 2 or more occasions; any Grade 3 or 4 non-hematologic toxicity (with the exception of grade 3 nausea or vomiting of less than 5 days duration, Grade 3 transaminases that returned to baseline value within 7 days of study drug interruption and that did not recur upon re-challenge with study drug, and/or Grade 3 fever or infection of <5 days duration); Grade 2 non-hematologic toxicities that persisted for >7 days and required treatment interruption, or any other capecitabine-related adverse events that required need for dose reduction or permanent cessation of therapy, interruption of study drug for >7 days or recurred on re-challenge with capecitabine rapidly disintegrating tablets (RDTs).|Upto 11 weeks|The safety population consisted of all eligible patients who received at least one dose of capecitabine.||Participants|||Number
132582|NCT00532948|Primary|Maximum Tolerated Dose (MTD) of Capecitabine.|The MTD was the dose level at which six evaluable patients had been treated and at most one patient experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 patients experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Upto 11 weeks.|The safety population consisted of all eligible patients who received at least one dose of capecitabine.||milligrams|||Number
132583|NCT00532935|Secondary|Percent of Participants With A1C <7.0% at Week 32||Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||Percent Participants|||Number
132584|NCT00532935|Secondary|Change From Baseline in FPG at Week 32|Change from baseline reflects the Week 32 FPG minus the baseline FPG|Baseline and Week 32|Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||mg/dL||95% Confidence Interval|Least Squares Mean
132585|NCT00532935|Secondary|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32|Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||mg/dL||95% Confidence Interval|Least Squares Mean
132586|NCT00532935|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1|Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone|Baseline and Week 1|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome.||mg/dL||95% Confidence Interval|Least Squares Mean
132587|NCT00532935|Primary|Change From Baseline in A1C at Week 32|A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent|Baseline and Week 32|The Full Analysis Set (FAS) included all patients who received at least one dose of double-blind study drug and had both a baseline value and ≥ 1 post-baseline value for this outcome. For FAS patients with no data at Week 32, the last non-baseline observed measurement was carried forward to Week 32.||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
132588|NCT00532883|Primary|Distribution of the Density of Hemoglobin SC Red Cells|An individuals’ percentage of red blood cells with density greater than 41 g/dL as measured by Advia.|measured 2 months after initiation of treatment|ITT: All randomized subjects who receive any clinical trial material. Subjects in the ITT population will be classified according to the treatment group to which they were randomized, regardless of what study drug they received.||percent of cells||Standard Deviation|Mean
132589|NCT00532779|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
132642|NCT00532155|Primary|Overall Survival (OS)|"OS was time interval from the date of randomization to the date of death due to any cause. If death was not observed during the study, overall survival time was censored at the last date the participant was known to be alive, or the study cutoff date, whichever was earlier. The cut-off date for the OS was date when 687 deaths were observed.~OS was estimated from Kaplan-Meier Curves."|Baseline to the date when 687 deaths occurred (26 January 2011)|All randomized participants.||months|Participants|95% Confidence Interval|Median
132590|NCT00532779|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
132591|NCT00532779|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
132592|NCT00532779|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
132593|NCT00532779|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
132594|NCT00532779|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
132595|NCT00532779|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
132596|NCT00532779|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
132597|NCT00532779|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
132598|NCT00532779|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
132599|NCT00532779|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
132600|NCT00532779|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
132601|NCT00532779|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
132602|NCT00532779|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
132603|NCT00532779|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
132604|NCT00532779|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||Percentage of participants||95% Confidence Interval|Number
132605|NCT00532779|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
132606|NCT00532779|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
132607|NCT00532493|Secondary|Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)|Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132608|NCT00532493|Secondary|Quality of Life Inventory (QOLI)|Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132609|NCT00532493|Secondary|SF-12 Mental Standardized Score (SF-12 MCS)|Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132610|NCT00532493|Secondary|SF-12 Physical Standardized Score (SF-12 PCS)|Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132611|NCT00532493|Secondary|Patient Health Questionnaire-9 (PHQ9)|Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132612|NCT00532493|Secondary|PTSD Checklist-Military Version (PCL-M) Score|Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.|This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132613|NCT00532493|Primary|Clinical Global Impression of Change (CGIC)|Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10||scores on a scale||Standard Deviation|Mean
132614|NCT00532493|Secondary|Total CAPS Score|Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.|The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132615|NCT00532493|Secondary|Clinical Global Impression of Change|Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.|This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132616|NCT00532493|Secondary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132617|NCT00532493|Secondary|Pittsburgh Sleep Quality Index|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).|11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks||scores on a scale||Standard Deviation|Mean
132618|NCT00532493|Primary|Pittsburgh Sleep Quality Index (PSQI)|Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10||scores on a scale||Standard Deviation|Mean
132673|NCT00531947|Secondary|Physical Examination (Screening vs. EOS)|Number of physical examination findings that were normal at screening, but abnormal at end of study are presented. Four subjects receiving placebo and four subjects receiving EMSAM had abnormal findings on physical examination at the end of study that were normal at screening.|12 Weeks|||Number of Abnormal Exams|||Number
132619|NCT00532493|Primary|CAPS Recurrent Distressing Dreams Item|Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.|This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.|17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10||scores on a scale||Standard Deviation|Mean
132620|NCT00532480|Primary|17-item Hamilton Depression Rating Scale|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|8 weeks|10 patients included in the study out of which 7 completed 8 weeks of the study||units on a scale||Standard Deviation|Mean
132621|NCT00532441|Secondary|Overall Survival|Determine Overall Survival|18 Months|||months||95% Confidence Interval|Median
132622|NCT00532441|Secondary|Response Rate|Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)|18 months|||participants|||Number
132623|NCT00532441|Primary|16 Weeks Progression-free Survival|To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|Start of treatment until disease progression per RECIST criteria up to 16 weeks|||months||95% Confidence Interval|Median
132624|NCT00532298|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
132625|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MSC was defined as at least one MSC experienced. Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
132626|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period (Day 0-20) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||Subjects|||Number
132627|NCT00532298|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
132628|NCT00532298|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
132629|NCT00532298|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.||Days||Full Range|Median
132630|NCT00532298|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was >20mm.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.||Subjects|||Number
132631|NCT00532298|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||Subjects|||Number
132632|NCT00532298|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||fold increase||95% Confidence Interval|Geometric Mean
132633|NCT00532298|Secondary|The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.|At Day 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||Subjects|||Number
132634|NCT00532298|Secondary|HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations|Antibody titers were expressed as GMTs. The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens. A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations. A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations. A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available.||titer||95% Confidence Interval|Geometric Mean
132635|NCT00532298|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens. A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season. A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.|At Days 0 and 21|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity were available. This primary outcome was assessed only on those groups receiving any of the GSK Bio's influenza vaccine GSK576389A formulations.||titer||95% Confidence Interval|Geometric Mean
132636|NCT00532259|Secondary|Overall Survival||within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).|||Percent||90% Confidence Interval|Number
132637|NCT00532259|Primary|Progression-free Survival|PFS (progression-free survival ) will be determined at the eligible patient populations|16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).|Patients who did not meet key study entry criteria were excluded from the eligible data set.||Percent||90% Confidence Interval|Number
132638|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Average Symptom Burden Index (ASBI)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies, and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for ABSI.||units on a scale||Standard Deviation|Mean
132639|NCT00532155|Secondary|Health Related Quality of Life (HRQL) Assessed by the Lung Cancer Symptom Scale (LCSS)|HRQL assessments were performed by participants using a self-administered LCSS questionnaire. LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline (prior to first dose), at cycles 2 and 4 and at the end of study therapy.|ITT population with questionnaires evaluable for LCSS.||units on a scale||Standard Deviation|Mean
132640|NCT00532155|Secondary|Overall Response (OR) Rate as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria|"Participants with OR were those who had a confirmed complete response [CR] or a confirmed partial response [PR], based on RECIST criteria, in which~CR refected the disappearance of all tumor lesions (with no new tumors)~PR reflected a pre-defined decrease in tumor burden - a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~OR was CR + PR The response rate was the percent of participants with a response.~To determine a response, tumors were assessed by the investigators using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 – 6 weeks."|Baseline to data cut-off (26 January 2011)|Evaluable population: All ITT participants with measurable disease at study entry, and with at least one valid post baseline tumor evaluation, except if the participant died due to progressive disease or had documented (ie, radiological) progression before having any post-baseline tumor evaluation.||percentage of participants|||Number
132641|NCT00532155|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time interval between the date of randomization and the time of occurrence of the first radiological tumor progression detected by a computer tomography (CT) scan and /or by Magnetic Resonance Imaging (MRI); or death due to any cause; whichever was earlier. Participants without disease progression were censored at the earliest date between their last valid tumour assessment and the data cutoff date.~PFS was estimated from Kaplan-Meier Curves."|Baseline to data cut-off (26 January 2011)|Intent to treat (ITT) population. The results are based on a total of 865 PFS events (434 in the placebo group and 431 in the aflibercept group) at the time of cutoff.||months|Participants|95% Confidence Interval|Median
132643|NCT00532129|Secondary|Mean Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores|EORTC QLQ-C30: included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.|Baseline, Day 1 of Cycles 5 and 11, end of follow-up (FU) (24 month [m] FU visit, up to approximately 3 years)|FAS. Number of participants analyzed = number of participants evaluable for this outcome and n=number of participants evaluable at the specified time point.||units on scale||Standard Deviation|Mean
132644|NCT00532129|Secondary|Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity|MRD negativity was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a confirmed CR. CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.||percentage of participants|||Number
132645|NCT00532129|Secondary|Overall Survival (OS) Time|This was defined as the interval (number of days) from the trial treatment start date to the date of death by any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants||95% Confidence Interval|Median
132646|NCT00532129|Secondary|Percentage of Participants Who Died||Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
132647|NCT00532129|Secondary|Duration of Response (DoR)|DoR: defined as interval (in days) from first tumor response (of CR/PR/nPR) to earlier of date of PD/death. Participants without PD/death or who were lost to follow-up were censored. CR: a)Absence of LD by PE and CT, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a)≥50% decrease in Lym count from baseline value, b)≥50% reduction in LD, c)≥50% reduction in size of liver/spleen by PE/CT scan and d)Leuk, Plat and Hb ≥1.5×10^9/L, >100×10^9/L and >11.0 g/dL, respectively or 50% improvement (of all the 3) over baseline value. nPR: participants who satisfied all of CR criteria except for BM, where LN could be identified. PD: a)≥50% increase in sum of the products of ≥2 lymph nodes or appearance of new lymph nodes/extranodal lesions, or b)≥50% increase in size of HSM; new appearance of palpable HM/SM, or c)≥50% increase in number of Lym, or d)Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR, PR or nPR.||days||95% Confidence Interval|Median
132648|NCT00532129|Secondary|Disease Free Survival (DFS) Time|DFS time was defined as interval (in days) from first tumor response of CR to date of first tumor response of PD, or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS population participants who achieved confirmed CR.||days||95% Confidence Interval|Median
132649|NCT00532129|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the interval (in days) from trial treatment start date to earlier of the date of first tumor response assessment of PD or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||days||95% Confidence Interval|Median
132650|NCT00532129|Secondary|Percentage of Participant With Disease Progression or Death|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
132651|NCT00532129|Secondary|Percentage of Participants With Objective Response (CR or PR)|Objective response was defined as a tumor response of CR or PR. CR was achieved if all of the criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR was achieved if all of the criteria were met: a)≥50% decrease in Lymp count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered PRs.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants||95% Confidence Interval|Number
132652|NCT00532129|Secondary|Percentage of Participants With BOR of Stable Disease (SD)|Participants without CR/PR or PD were considered having a tumor response of SD. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a) ≥50% decrease in Lym count from baseline, b) ≥50% reduction in LD, c) ≥50% reduction in size of liver/spleen by PE/CT and ≥1 of the following for at least 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
132653|NCT00532129|Secondary|Percentage of Participants With BOR of Progressive Disease (PD)|PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of hepatosplenomegaly (HSM) as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
132654|NCT00532129|Secondary|Percentage of Participants With BOR of Nodular Partial Response (nPR)|CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. Participants with nPR were those who satisfied all of the CR criteria except for the BM, where LN could be identified histologically.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
132655|NCT00532129|Secondary|Percentage of Participants With BOR of Partial Response (PR)|PR was achieved if all of the following criteria were met: a)≥50% decrease in Lym count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered in PRs. CR was achieved if all of the criteria were fulfilled for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
132656|NCT00532129|Secondary|Percentage of Participants With Best Overall Response (BOR) of Clinical CR or Confirmed CR|Clinical CR was achieved if all of the following criteria were met: a)Absence of lymphadenopathy (LD) by physical examination (PE) and Computed Tomography (CT) scan (all lymph nodes less than [<] 1.5 centimeters [cm] in diameter), b)No hepatomegaly (HM)/splenomegaly (SM) by PE/CT scan, c)Absence of B symptoms (unexplained fever greater than [>] 38 degrees [°] Centigrade [C], drenching night sweats/>10 percent [%] body weight loss in the last 6 months), d)Normal Complete Blood Count (CBC) (i. Leukocytes (Leuk) greater than or equal to [≥] 1.5×10^9 per liter (/L), ii. Platelets (Plat) >100×10^9/L, and iii. Haemoglobin (Hb) >11.0 grams per deciliter [g/dL]) and e)Once clinical, radiological and laboratory evaluations demonstrated CR, bone marrow (BM) biopsy and aspirate were performed 8 weeks later for confirmation; BM sample: normocellular for age, <30% of the cells being lymphocytes (Lym) and lymphoid nodules (LN) absent was considered as a confirmed CR.|Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)|FAS.||percentage of participants|||Number
132657|NCT00532129|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 56 days from the beginning of the last treatment cycle that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs as well as non-serious AEs.|First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)|FAS.||percentage of participants|||Number
132658|NCT00531960|Secondary|Percentage of Participants With Disease Control According to RECIST V 1.0|Disease control was defined as a BOR of CR, PR, or SD according to RECIST V 1.0 for at least 4 weeks at any time during randomized treatment or disease stabilization, after study entry. Participants without a post-BL assessment of response were considered as having no disease control. The 95% CI for the one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis, 12 months after the last participant’s 1st visit|FAS||percentage of participants||95% Confidence Interval|Number
132659|NCT00531960|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|BOR was defined as the best response recorded from randomization until disease progression/recurrence or death, taking as reference for PD the smallest measurement (nadir) recorded since treatment started. Assignment of PR of CR required confirmation of tumor measurement changes by repeat assessments performed no less than 4 weeks after criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs; and PR was defined as at least a 30% decrease in the SLD of the TLs, taking BL SLD as reference. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was calculated using the Pearson-Clopper method.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS||percentage of participants||95% Confidence Interval|Number
132660|NCT00531960|Secondary|OS|The median time, in months, from randomization to OS event. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants who died were included in this analysis.||months||95% Confidence Interval|Median
132661|NCT00531960|Secondary|Percentage of Participants Who Died|Overall survival (OS) was defined as the time from randomization to the date of death, due to any cause. Participants were censored at final analysis at the date the participant was last known to be alive.|Screening, Days 1, 8, and 21 of Cycles 1-8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS||percentage of participants|||Number
132662|NCT00531960|Primary|PFS|The median time, in weeks, from randomization to PFS event. Participants were censored at the date of last post-BL tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization. PFS was estimated using Kaplan-Meier methodology.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS; only participants with an event (disease progression or death) were included in the analysis.||weeks||95% Confidence Interval|Median
132663|NCT00531960|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death, from any cause. Progressive disease (PD) was defined according to Response Criteria in Solid Tumors (RECIST) version (V) 1.0. For target lesions (TLs), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants were censored at the date of last post-baseline (BL) tumor assessment where non-progression was documented. If no post-BL tumor assessment was available, the participant was censored at date of randomization.|Screening, end of every 2nd cycle through Cycle 8 (21-day cycles), and every 12 weeks thereafter until the end of study and final analysis up to a maximum of 42 months.|FAS||percentage of participants|||Number
132664|NCT00531947|Secondary|Hematology - Red Blood Cell (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Red Blood Cell (RBC)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks|||x10^12/L||Standard Deviation|Mean
132665|NCT00531947|Secondary|Hematology - Hemoglobin (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hemoglobin(HGB)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks|||g/dL||Standard Deviation|Mean
132666|NCT00531947|Secondary|Hematology - Hematocrit (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology - Hematocrit(HCT)(Change from Baseline), by treatment assigned, is shown for the safety population.|12 Weeks|||percent||Standard Deviation|Mean
132667|NCT00531947|Secondary|Hematology - White Blood Cell (WBC) (Change From Baseline)|A summary of a secondary safety outcome measure, Hematology (Change from Baseline), by treatment assigned, is shown for the safety population. Mean change from Baseline in ABS BASOPHILS (X10^9/L), ABS EOSINOPHILS (X10^9/L), ABS LYMPHOCYTES (X10^9/L), ABS MONOCYTES (X10^9/L), and ABS NEUTROPHILS (X10^9/L) are presented.|12 Weeks|||(X10^9/L)||Standard Deviation|Mean
132668|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)Ventricular Heart Rate|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline)Ventricular Heart Rate measured in beats per minute(beats/min or BPM), by treatment assigned, is shown for the safety population. Mean change from baseline is presented.|12 Weeks|||BPM||Standard Deviation|Mean
132669|NCT00531947|Secondary|12 Lead ECG (Change From Baseline)|A summary of a secondary safety outcome measure, 12 Lead electrocardiogram (ECG) (Change from Baseline) measured in milliseconds (msec), by treatment assigned, is shown for the safety population. Mean change from Baseline in PR interval, QRS duration, QT interval, and QTc (Bazett and Fridericia corrections) interval are presented.|12 Weeks|||msec||Standard Deviation|Mean
132670|NCT00531947|Secondary|Vital Signs-Blood Pressure (Change From Baseline)|Summary mean change in blood pressure (systolic/diastolic) measured in millimeters of mercury (mmHg) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks|||mmHg||Standard Deviation|Mean
132671|NCT00531947|Secondary|Vital Signs-Heart Rate (Change From Baseline)|Summary mean change in heart rate measured in beats per minute (beats/min or BPM) (supine, standing, and orthostatic change)results for all subjects are presented.|12 Weeks|||BPM||Standard Deviation|Mean
132672|NCT00531947|Secondary|Urinalysis (Change From Baseline)|A summary of a secondary safety outcome measure, Urinalysis (Change from Baseline), by treatment assigned, is shown for the safety population. Mean changes from baseline are provided for PH and specific gravity.|12 Weeks|||units on a scale||Standard Deviation|Mean
132674|NCT00531947|Primary|CDRS-R Total Score (Child) (mITT w/LOCF Population) Week 12|"A summary of the primary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score, as reported by the Child, at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~CDRS-R total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).||units on a scale||Standard Deviation|Mean
132675|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with observed cases (w/OC).~Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom area. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.~CDRS-R (Best Description) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks|||units on a scale||Standard Deviation|Mean
132676|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/OC Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).~CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|12 Weeks|||units on a scale||Standard Deviation|Mean
132677|NCT00531947|Secondary|CDRS-R Total Score (Child) Week 12 (mITT w/OC Population)|"A summary of the secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Child), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population with observed cases (w/OC).~CDRS-R (Child) total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks|||units on a scale||Standard Deviation|Mean
132678|NCT00531947|Secondary|CDRS-R Total Score (Best Description) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Best Description), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~Best Description ratings are used when ratings based on interviews with different sources (e.g., child, parent, other ratings) differ for a particular symptom. The evaluator must determine which of these ratings most accurately represents the current affective functioning of the child, and circle that rating in the Best Description of Child Column.~CDRS-R (Best Description)total raw scores range from 17(minimum) 113(maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. Two subscales are summed to calculate a total score: Evaluated Symptom Area and Ratings of Observed Nonverbal Behavior."|12 Weeks|||units on a scale||Standard Deviation|Mean
132679|NCT00531947|Secondary|CDRS-R Total Score (Parent/Other) Week 12 (mITT w/LOCF Population)|"A summary of a secondary efficacy outcome measure, Children's Depression Rating Scale (CDRS-R) Total Score (Scored by Parent/Other), at Week 12 (EOS), by treatment assigned, is shown for the modified intent-to-treat (mITT) population, with the last observation carried forward (LOCF) in time.~CDRS-R (Parent/Other) total raw scores range from 14 (minimum) 94 (maximum). A lower score indicates a lower likelihood of a depressive disorder, a higher score indicates a higher likelihood of a depressive disorder. One subscale is summed to calculate a total score: Evaluated Symptom Area. Ratings of Observed Nonverbal Behavior subscale is not included in Parent/Other total calculation."|Baseline and 12 Weeks|||units on a scale||Standard Deviation|Mean
132680|NCT00531947|Secondary|CGI-C Percent Responders (mITT w/LOCF Population)|A summary of the CGI-C percent responders at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. CGI-C responders were defined as a score of 1 or 2 at the end of the study. A non-responder was defined as a score of ≥3 at end of study. Maximum score is 100%.|12 Weeks|||Percent Responder|||Number
132681|NCT00531947|Secondary|CGI-C - Week 12 (mITT w/LOCF Population)|"A summary of the Clinicians Global Impression of Change (CGI-C) Score at Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-c assesses the overall change in the severity of illness (depression). The clinician rates the subject's change based on a bipolar scale from 1(minimum; Very much improved) to 7(maximum; Very much worse). A lower score indicates lower levels of depression as compared to baseline, a higher score indicates higher levels of depression as compared to baseline. A score of 4 (Unchanged) indicates no change in illness compared to baseline. The scale is not calculated as a statistical change score; the clinician rates their impression of change overall."|12 Weeks|||units on a scale||Standard Deviation|Mean
132682|NCT00531947|Secondary|CGI-S - Week 12 (mITT w/LOCF Population)|A summary of the Clinical Global Impression of Severity (CGI-S) at baseline and Week 12 (EOS), by treatment assigned, is shown for the mITT population with LOCF. The CGI-s is the clinician's assessment of severity of illness (depression). Scores range from 1(minimum) to 7(maximum). A lower score indicates lower illness severity, a higher score indicates higher levels of illness severity.|Baseline and 12 Weeks|Received at least one dose of placebo or EMSAM study drug, and had at least one post-treatment efficacy assessment with the primary outcome variable (CDRS-R).||units on a scale||Standard Deviation|Mean
132697|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type|Other skin lesions included xerosis and paronychia.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
132683|NCT00531934|Secondary|Quality of Life Score as Assessed by Visual Analog Scale (VAS)|Quality of life was assessed by participant's responses to a VAS questionnaire - (evaluation of satisfaction with skin status). VAS was measured on a 100 millimeter (mm) scale where 0 = not at all satisfied and 100 = very satisfied. Participants were asked to mark the line corresponding to their satisfaction at each visit and the distance from the left edge was measured. A negative change from baseline indicates improvement. Analysis was performed by visit well as at the last available value after baseline (Endpoint).|Baseline, Days 14 and 28, and Months 2, 3, and 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
132684|NCT00531934|Secondary|Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. The DLQI global score was classified into 5 levels: 0-1 (no effect at all), 2-5 (small effect), 6-10 (moderate effect), 11-20 (very large effect) and 21-30 (extremely large effect).|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
132685|NCT00531934|Secondary|Dermatology Life Quality Index (DLQI) Global Score|Quality of life was assessed by participant's responses to a DLQI questionnaire. The DLQI is a 10-item questionnaire assessing quality of life; questions were assessed on a 4-point scale (0=not at all; 1=a little; 2=a lot; and 3=very much). The DLQI was calculated by summing the score of each question resulting in a maximum of 30 (extremely large effect on participant's life) and a minimum of 0 (no effect at all on participant's life). The higher the score, the more quality of life is impaired. Analysis was performed by visit well as at the last available value after baseline (Endpoint); change from baseline to endpoint was also determined.|Baseline, Days 14 and 28 and Months 2, 3, and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
132686|NCT00531934|Secondary|Percentage of Participants Estimated to be Alive at 4 and 12 Months||Months 4 and 12|ITT Population||percentage of participants|||Number
132687|NCT00531934|Secondary|Overall Survival (OS) - Time to Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||days||95% Confidence Interval|Median
132688|NCT00531934|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined by the time between first intake of treatment with erlotinib and death for any cause; analyzed using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||percentage of participants|||Number
132689|NCT00531934|Secondary|Percentage of Participants Estimated to be Progression Free at 4 and 12 Months||Months 4 and 12|ITT Population||percentage of participants|||Number
132690|NCT00531934|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||days||95% Confidence Interval|Median
132691|NCT00531934|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined by the time between first intake of treatment with erlotinib and disease progression or death for any cause; estimated using Kaplan-Meier method.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||percentage of participants|||Number
132692|NCT00531934|Secondary|Percentage of Participants by Best Global Response Under Treatment|Response was determined according to the RECIST criteria for evaluation and was defined as participants with either CR, PR, SD, or progression. No CR was reported.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population||percentage of participants|||Number
132693|NCT00531934|Secondary|Percentage of Participants With Global Disease Control by Visit|Disease control was determined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation and was defined as participants with either complete response (CR), partial response (PR), or stable disease (SD).|Months 2, 4, 7, 10, and 12|ITT population; number (n) = number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
132694|NCT00531934|Secondary|Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction|Occurrence of folliculitis-type skin rash of Grade greater than or equal to (≥)2 led to dose modification. Continuation of treatment with doxycycline after occurrence of folliculitis-type skin rash of Grade ≥2 was upon the investigator’s opinion.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted doxycycline were included in the analysis.||percentage of participants|||Number
132695|NCT00531934|Secondary|Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction|Erlotinib dose adjustment was done in case of toxicity occurrence. Keratitis, diarrhea, interstitial lung disease, and other toxic occurrences determined erlotinib dose reduction. If erlotinib was previously discontinued for skin rash or diarrhea of Grade 2 and if these symptoms of Grade 2 recurred OR if the symptoms were intolerable for the participants, erlotinib was discontinued until recovery/Grade 1 then the dose was reduced of one level of 50 mg.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population; only participants that discontinued or interrupted erlotinib were included in the analysis.||percentage of participants|||Number
132696|NCT00531934|Secondary|Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity|Other skin lesions included xerosis and paronychia. Intensity was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation; Grade 4=Generalized exfoliative, ulcerative, or bullous dermatitis. If a participant had several skin lesions, the maximal intensity was taken into account.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event classified as other skin lesion during the first 4 months were included in the analysis.||percentage of participants|||Number
132699|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the Whole Treatment Period|If the end of cutaneous rash was missing, the duration of cutaneous rash was calculated between start of folliculitis and last evaluation date.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT Population; only participants with an event (folliculitis) were included in the analysis.||days||Standard Deviation|Median
132700|NCT00531934|Secondary|Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment|If the cutaneous rash was ongoing at the last visit or Month 4, the duration of cutaneous rash was calculated between start of folliculitis and Visit Month 4 or premature withdrawal visit or death.|Days 0, 14, 28 and Months 2, 3, and 4|ITT Population; only participants with an event (folliculitis) were included in the analysis.||days||Standard Deviation|Mean
132701|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 12 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 12 months.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population||percentage of participants|||Number
132702|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population||days||95% Confidence Interval|Median
132703|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12|ITT population||participants|||Number
132704|NCT00531934|Secondary|Percentage of Participants Estimated to be Event Free at 4 Months|Percentage of participants estimated to be without skin rash (folliculitis) at 4 months.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
132705|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||days||95% Confidence Interval|Median
132706|NCT00531934|Secondary|Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event|Period without occurrence was determined as the number of days from the first dose of medication until the first appearance of folliculitis, analyzed using Kaplan-Meier analysis.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||participants|||Number
132707|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1=Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering <50% of BSA; Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Months 7, 10, and 12|ITT population||participants|||Number
132708|NCT00531934|Secondary|Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Months 7, 10, and 12|ITT population||participants|||Number
132709|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Months 7, 10, and 12|ITT population||rash events|||Number
132710|NCT00531934|Secondary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment||Months 7, 10, and 12|ITT population||percentage of participants|||Number
132711|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity|Intensity of skin rashes was classified according to CTCAE grading. Grade 1 equals (=) Macular or papular eruption or erythema without associated symptoms; Grade 2=Macular or papular eruption or erythema with pruritus or other associated symptoms; localized desquamation or other lesions covering less than (<)50 percent (%) of body surface area (BSA); Grade 3=Severe, generalized erythroderma or macular, papular, or vesicular eruption; desquamation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; only participants with an adverse event of skin rash (folliculitis) during the first 4 months were included in the analysis.||percentage of participants|||Number
132712|NCT00531934|Secondary|Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustule, nodule, and crust.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||percentage of participants|||Number
132713|NCT00531934|Secondary|Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment|A cutaneous rash as folliculitis can be defined with several types including erythema, papulo-pustular and nodules.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population||rash events|||Number
132714|NCT00531934|Primary|Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment|Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.|Days 0, 14, 28 and Months 2, 3, and 4|ITT population; data for 1 participant in the erlotinib treatment group were missing.||percentage of participants|||Number
132715|NCT00531843|Secondary|Increased Bleeding Attributed to Fondaparinux|Coagulopathic bleeding due to fondaparinux was suspected in patients requiring packed red cell transfusions after initiation of fondaparinux therapy only if the change in hematocrit prompting transfusion was not clinically commensurate with the degree of injuries that the patient had sustained (primarily orthopaedic) and/or the hematocrit did not respond appropriately post-transfusion.|3 weeks post injury|||participants|||Number
132774|NCT00531427|Secondary|Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.|Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).|10 weeks|Subjects in the full analysis population who took at least 1 dose of supplemental analgesic medication.||tablets||Standard Deviation|Mean
132716|NCT00531843|Primary|Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)|Color-flow duplex venous ultrasonography examinations of upper and lower extremities were performed within 48 hours of injury, and then weekly until discharge or 3 weeks. DVT was defined as any clot occurring in the subclavian, iliac, femoral, or popliteal location. Patients were examined daily for clinical signs and symptoms of venous thromboembolism (VTE) and PE. Small, nonocclusive clots discovered in other locations were observed for progression on sequential ultrasonography examinations.|within 3 weeks post injury|Of 11 patients with initial contraindication to anticoagulation, 5 were cleared by the treating physicians to receive fondaparinux within 3 days of injury, and 6 were not.||participants|||Number
132717|NCT00531843|Secondary|Normal Trough and Peak Fondaparinux Concentration|Serum samples were collected 30 minutes before (trough) and 2 hours after (peak) the third dose of fondaparinux. Normative data plots comparing study participants with healthy volunteers were supplied by the company outsourced to analyze samples.|Day 3|Serum samples were obtained from 63 representative patients from our study who received Fondaparinux and compared against normative values from normal volunteers supplied by our sponsor.||Participants|||Number
132718|NCT00531817|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7|Serum concentration of CRP (high-sensitivity CRP [hsCRP] test) was analyzed by a central laboratory.|Baseline to Days 3 and 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. No imputation of missing data was made; only observed data are reported.||mg/dL||Standard Deviation|Mean
132719|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Day 7|C-reactive protein (CRP) population: A subset of patients enrolled at designated study sites who met the CRP entry criteria (CRP ≥ 1 mg/dL), received at least 1 dose of study medication, and attended the Day 3 or Day 7 visit. LOCF was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.||Percentage of participants|||Number
132720|NCT00531817|Secondary|Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (0-10), a pain visual analog scale score (VAS, 0-100), and a global assessment of disease activity VAS score (0-100). Each domain was assessed with the Patient Take Home Form (PTHF). Higher scores indicate more disease activity. A negative change score indicates improvement.|Baseline through Day 7|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
132721|NCT00531817|Secondary|Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24|The MOS Sleep Scale is a 12-item patient self-report instrument that assesses the quality and quantity of sleep over the previous 4 weeks. A sleep problems index (SLP9) was generated using 9 of the 12 items (1, 3, 4, 5, 6, 7, 8, 9, 12). Each item was normalized so that the lowest and highest possible scores were set to 0 and 100, respectively. The SLP9 score is the average of the recoded 9 items. The SLP9 score ranged from 0 to 100. Higher scores represent greater sleep problems. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
132722|NCT00531817|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24|The FACIT-F is a 13-item patient self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
132723|NCT00531817|Secondary|Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24|The SF-12 is a self-report measure of general health status with 1 or 2 items for each of 8 domains: Physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Two component summaries, physical (PCS-12) and mental (MCS-12) were calculated using norm-based scoring, resulting in means of 50 and standard deviations of 10 in the 1998 general United States population. Higher scores represent better health and a positive change from baseline represents improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
132724|NCT00531817|Secondary|Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24|Derived from the Multidimensional Health Assessment Questionnaire (MDHAQ), the RAPID includes 3 domains that assess disease activity in rheumatoid arthritis: A physical function score (MDHAQ items 1a-j), a pain visual analog scale score (VAS, item 2 in the MDHAQ), and a global assessment of disease activity VAS score (item 6 in the MDHAQ). Each domain is scored on a scale of 0-10. The RAPID score is the sum of the 3 domain scores divided by 3 resulting in a total score on a scale of 0-10. Higher scores indicate more disease activity and a negative change from baseline indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
132725|NCT00531817|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24|Change of the DAS28 score from baseline was used to determine the EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. Missing data was imputed as “no response”.||Percentage of participants|||Number
132726|NCT00531817|Secondary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24|DAS28 was calculated using the following formula: 0.56 × sqrt(TJC) + 0.28 × sqrt(SJC) + 0.70 × ln(ESR) + 0.014 × GH, where TJC = tender joint count on 28 joints, SJC = swollen joint count on 28 joints, ESR = erythrocyte sedimentation rate at the current visit (mm/hr), and GH = general health, ie, the patient’s global assessment of disease activity (DA) in the previous 24 hours on a 100 mm visual analog scale (no DA to maximum DA). The DAS28 score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. A negative change score indicates improvement.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. No imputation of missing data was made; only observed data are reported.||Units on a scale||Standard Deviation|Mean
132727|NCT00531817|Primary|Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.||Percentage of participants|||Number
132728|NCT00531817|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population: All randomized patients who received at least 1 dose of study medication. In determining ACR status, a last observation carried forward (LOCF) approach was used for missing joint count data. Patients with missing data or who escaped were classified as non-responders.||Percentage of participants|||Number
132729|NCT00531752|Other Pre-specified|Treatment Duration|Treatment duration was defined as the total number of dosing days from first to last day of study drug administration in each period.|Day 1 up to Day 21|Safety analysis set consisted of all participants who took at least 1 dose of study medication.||days||Full Range|Mean
132730|NCT00531752|Other Pre-specified|Number of Participants With Change From Baseline in Physical Examination and Neurological Examination|Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal system.|Baseline up to 1 week after last study dose (1 week after end of Period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.||participants|||Number
132731|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or >120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum increase from baseline in systolic BP >=30 mmHg, maximum increase from baseline in diastolic BP >=20 mmHg.|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
132732|NCT00531752|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum QTc interval of 450 to <480 msec, 480 to <500 msec and >=500 msec.|Baseline up to End of Treatment (Week 3 of period 2)|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
132733|NCT00531752|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose).|Baseline up to 1 week after last study dose|Safety analysis set consisted of all participants who took at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
132808|NCT00531206|Secondary|CD4+ Cell Count|Change from baseline in CD4+ count over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated||cells/mm3||Inter-Quartile Range|Median
132734|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132735|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Total WASO subscale score ranges from 0 to 24 hours. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||hours||Standard Deviation|Mean
132736|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Number of awakenings subscale score ranges from 0 to 30. Lower value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||awakenings||Standard Deviation|Mean
132737|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3|"SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), WASO (1 item), quality of sleep (1 item).~Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep."|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||hours||Standard Deviation|Mean
132738|NCT00531752|Other Pre-specified|Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3|SSQ is a 5-item self-report scale that was designed to evaluate the amount and quality of sleep and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total awake after sleep onset (WASO [1 item]), quality of sleep (1 item). Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||minutes||Standard Deviation|Mean
132739|NCT00531752|Other Pre-specified|Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep, and overall sleep problem index (SPI) I (range 0 to 600) and II. Except for sleep quantity and sleep problem index I, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline, Week 1, 2, 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132740|NCT00531752|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3|SDS was a participant-rated questionnaire assessing the effect of the participant's symptoms on the 3 domains/subscales: work/school, social life/leisure activities, and family/home management. Each domain was rated on visual analog scale ranges from 0 to 10 where 0=not at all impaired and 10=extremely impaired, and total SDS score was calculated as a sum of all the domains with a score range of 0=not at all impaired to 30=extremely impaired. Disability scores were reported for each of the domains/subscales. Higher scores reflect greater impairment.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for given subscale at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132741|NCT00531752|Secondary|Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3|AAQoL is a 29-item questionnaire consisting of 4 subscales: life productivity (11 items), psychological health ([PH] 6 items), life outlook (7 items) and relationships (5 items). Participants rated each item on a scale ranging from 1 (not at all/never) to 5 (extremely/very often). The scores of each item were then transformed to a 0 to 100 point scale, higher scores indicating better quality of life. The score for each subscale was calculated as the sum of the corresponding item scores. Total score ranges were: life productivity (0 to 1100), psychological health (0 to 600), life outlook (0 to 700) and relationships (0 to 500), where higher subscale score indicates better quality of life for each subscale.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132809|NCT00531206|Secondary|Change in Viral Load|Log10 change from baseline in viral load over time|Baseline and 52 weeks|Full Analysis Set (FAS), all patients entered and treated||log10 copies/ml||Inter-Quartile Range|Median
132742|NCT00531752|Secondary|Change From Baseline in ADHD Impact Module – Adults (AIM-A) Subscale Score at Week 3|AIM-A: 66 item questionnaire completed by the participant to assess the impact of ADHD on the participant’s quality of life. It is comprised of 4 global quality of life (QoL) items (current quality of life item [CQoLI], range:1 to 10; global limitation item [GLI]: range:1 to 4, on the right track item [RTI], range:1 to 3, more good days [GD] than bad days [BD], range:1 to 5, higher scores indicate a better QoL for all the 4 QoL items) and 6 multi-item subscales (living with ADHD, general well-being, performance and daily functioning [PDF], relationships and communication [R/C], Impact of symptoms-bother/concern [IS-B/C] scale, and impact of symptoms-interference [IS-I] scale). Participants responded to each item of multi-item subscale using a likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Multi-item subscale scores were calculated as an average of scores for the contributing items and transformed into 0 to 100 score where higher scores indicate a better QoL.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132743|NCT00531752|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3|HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item was scored on a scale ranging from 0 (not present) to 4 (very severe) with a total score range of 0 to 56, where higher score indicates greater anxiety.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132744|NCT00531752|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3|The MADRS scale measures the depression level of a participant. It is administered as a semi-structured clinician interview. The total score is derived by adding the scores of the following 10 items: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. Each item is scored using a 6-point scale which ranges from 0 to 6 (a higher score indicates increased severity). The total score range was 0 to 60 where 0 indicates no depression and 60 indicates severely depressed.|Baseline, Week 3|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132745|NCT00531752|Secondary|Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponded to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period.|Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21|Analysis population included all participants in PP analysis set and 1 additional participant in PF-03654746 (Flexible Dose) for whom the post-baseline data was available.‘N’ (number of participants analyzed)=evaluable participants for this measure and ‘n’= evaluable participants for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132746|NCT00531752|Secondary|Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). The AISRS inattention and hyperactive/impulsive total subscale score range from 0 to 27. A higher total subscale score corresponded to a worse severity of ADHD inattention or hyperactivity/impulsivity.|Baseline, Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132747|NCT00531752|Secondary|Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score|TASS: a time sensitive 18-item questionnaire completed by the participant that measured the severity of current ADHD symptoms. It included 9 items that evaluate symptoms of inattention sub-scale and 9 items that evaluate symptoms of impulsivity and hyperactivity sub-scale. Each item was rated from 0 (none) to 3 (severe). TASS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher total score corresponds to a worse severity of ADHD. TASS was administered each day from Day 1 to 14 and on Day 21 in each intervention period. Participants with sustained response were those who had at least 30 percent decrease from baseline in TASS total score, which was maintained at all visits up to the time of assessment. Sustained responders at Day 7, 14 and 21 were analyzed.|Day 7, 14, 21|PP analysis set: all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
132748|NCT00531752|Secondary|Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
132749|NCT00531752|Secondary|Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Participants with a score of 1 (normal - not ill at all) or 2 (borderline mentally ill) are reported.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
132750|NCT00531752|Secondary|Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Week 1, 2, 3|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||percentage of participants|||Number
132751|NCT00531752|Secondary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 1, 2|PP analysis set:all participants included in FAS and had no major protocol violation affecting primary efficacy variable. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.||units on a scale||Standard Deviation|Mean
132752|NCT00531752|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline, Week 3|Per Protocol (PP) set: all participants included in full analysis set (FAS=who received at least[>=]1 dose of randomized study drug,had baseline and >=1 post-baseline measurement of primary efficacy variable)and had no major protocol violation affecting primary efficacy variable. n=participants evaluable at specified time points for each arm.||units on a scale||Standard Deviation|Mean
132753|NCT00531661|Other Pre-specified|Freedom From Pressure Sensor Failure||Study duration: average patient follow-up of 15 months|||participants|||Number
132754|NCT00531661|Other Pre-specified|Freedom From a Device/System-related Complication (DSRC)||Study duration: average patient follow-up of 15 months|||participants|||Number
132755|NCT00531661|Other Pre-specified|Rate of HFR Hospitalizations||Study duration: average patient follow-up of 15 months|||HFR hospitalizations/patient-year|||Number
132756|NCT00531661|Secondary|Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)|THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual’s quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.|6 months|||units on a scale||Standard Deviation|Mean
132757|NCT00531661|Secondary|Days Alive Outside of the Hospital||6 months|||days||Standard Deviation|Mean
132758|NCT00531661|Secondary|Proportion of Patients Hospitalized for Heart Failure||6 months|||participants|||Number
132759|NCT00531661|Secondary|Change From Baseline in Pulmonary Artery Mean Pressure|Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.|6 months|||mmHg * days||Standard Deviation|Mean
132760|NCT00531661|Primary|Freedom From Pressure Sensor Failure|A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC).||participants|||Number
132761|NCT00531661|Primary|Freedom From a Device/System-related Complication (DSRC).|"A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:~is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)~results in the death of the subject~results in the explant of the device"|6 months|This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device as well as patients where an implant was attempted. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC). This population includes 550 implanted patients + 25 patient attempts.||cases|Participants||Number
132762|NCT00531661|Primary|Rate of Heart Failure Related (HFR) Hospitalizations||6 months|||HFR hospitalizations/patient/6 months|||Number
132881|NCT00530842|Secondary|Forced Vital Capacity (FVC)|Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132763|NCT00531518|Primary|Psychotic Symptoms|Psychotic symptoms were assessed and scored using the Structured Interview for the Prodromal Syndrome (SIPS) and the Scale of Prodromal Symptoms (SOPS). The SOPS provides a measure of four domains of symptoms, including positive, negative, disorganized and general symptoms. The Positive Symptom sub-scale score reported is the sum of all five symptom items in the Positive Symptom sub-scale. The Positive Symptom sub-scale assesses psychotic symptoms, each item on a scale of 0-6. The sum scale score is 0-30, with 30 indicating severe psychotic symptoms, while 0 indicates no psychotic symptoms.|two years|||units on a scale||Standard Deviation|Mean
132764|NCT00531479|Secondary|Time to Death Due to Invasive Aspergillosis (IA)|Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment. Participants who died due to causes other than IA were defined as censored at time of death.||days||Full Range|Median
132765|NCT00531479|Secondary|Time to Death: All-Cause Mortality|Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N = number of participants in MITT population at time of assessment.||days||Full Range|Median
132766|NCT00531479|Secondary|Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA|Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Participants who died due to causes other than IA before Week 6 were censored at their time of death in this analysis.||participants|||Number
132767|NCT00531479|Secondary|All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 84 (Week 12)|MITT; N=number of participants in MITT population at Week 12.||participants|||Number
132768|NCT00531479|Secondary|All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)|Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Intent-to-treat (ITT) population: participants in MITT analysis set plus participants with possible IA who could not be upgraded to probable or proven IA within 7 days and had received at least 1 dose of study medication. N=number of participants in ITT population at Week 6.||participants|||Number
132769|NCT00531479|Secondary|Global Response at Week 6|Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and >90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and >50% improvement in radiological findings present at BL.|Baseline, Day 42 (Week 6)|MITT; N = number of participants in MITT population at Week 6. Missing data and participants who died at Week 6 were treated as failure.||participants|||Number
132770|NCT00531479|Primary|All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis|Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.|Day 1 to Day 42 (Week 6)|Modified intent-to-treat (MITT) population: all randomized participants with proven or probable IA confirmed by Day 7 following enrollment who received at least 1 dose of study medication. N=number of participants in MITT population at Week 6. Participants not known to have died were censored at last study visit (Day 84).||participants|||Number
132771|NCT00531453|Secondary|Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)|"Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-transplantation response assessment. The response-evaluable population comprises 38 subjects in the VDT treatment group and 27 subjects in the VDTC group.||percentage of participants|||Number
132772|NCT00531453|Primary|Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction|"Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow."|all data included in clinical database as of 10 April 2009|The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-baseline response assessment. The response-evaluable population comprises 49 subjects in the VDT treatment group and 48 subjects in the VDTC group.||percentage of participants|||Number
132773|NCT00531427|Secondary|Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the double-bind phase|Full Analysis Population (N = 570) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Deviation|Mean
132810|NCT00531206|Primary|Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients with adverse events|||Number
132775|NCT00531427|Primary|"Average Pain Over the Last 24 Hours Score of the Study Knee at Week 12 of the Double Blind Phase."|"Average pain over the last 24 hours” scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily."|24 hours (week 12)|The full analysis population is the group of subjects who were randomized and received at least 1 dose of double-blind study drug||units on a scale||Standard Deviation|Mean
132776|NCT00531284|Secondary|Mean Residence Time (MRT) Extrapolated to Infinity for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||hours||Standard Deviation|Mean
132777|NCT00531284|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||liters||Standard Deviation|Mean
132778|NCT00531284|Secondary|Clearance (CL) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||liters/hour||Standard Deviation|Mean
132779|NCT00531284|Secondary|Elimination Half-life (t½) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||hours||Full Range|Median
132780|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
132781|NCT00531284|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Concentration Measured (AUC0-last) for Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
132782|NCT00531284|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib||Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||hours||Full Range|Median
132783|NCT00531284|Secondary|Maximum Observed Plasma Concentration of Carfilzomib|Plasma concentrations of carfilzomib were determined by a validated liquid chromatography tandem mass spectrometry method. Concentration values that were below the lower limit of quantification of 0.1 ng/mL were set to zero. Treatment groups receiving the same dose (e.g. 20 mg/m²) were combined for Day 1 analyses.|Cycle 1, Day 1, predose and at 5 minutes and 15 minutes post start of infusion (for 30-minute infusion groups only), and at the end of infusion, 5, 15, and 30 minutes; and 1, 2, and 4 hours after the end of the infusion.|Safety population with available pharmacokinetic (PK) data. PK analyses were conducted in solid tumor and multiple myeloma groups only and were not conducted for lymphoma or participants enrolled under Amendment 4 (CFX + dexamethasone).||ng/mL||Geometric Coefficient of Variation|Geometric Mean
132784|NCT00531284|Secondary|Time to Progression|Time to Progression (TTP) is defined as number of months between start of treatment and first evidence/documentation of disease progression.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population.||months||95% Confidence Interval|Median
132785|NCT00531284|Secondary|Progression-Free Survival|Progression-free survival (PFS) is the time from start of treatment to disease progression or death (due to any cause), whichever occurred first.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety population||months||95% Confidence Interval|Median
132786|NCT00531284|Secondary|Duration of Response|Duration of response is defined as the time from first evidence of a partial response or better (the first observation of PR before confirmation) to disease progression, with deaths owing to causes other than progression censored.|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population with a partial response or better||months||95% Confidence Interval|Median
132832|NCT00531011|Secondary|Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .|This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.|at 30 days|ITT||percentage of participants|||Number
132787|NCT00531284|Secondary|Percentage of Participants With an Overall Response Throughout the Study|"Solid tumor participants were evaluated for disease response according to RECIST, Version 1.1. Multiple myeloma participants were evaluated using the International Myeloma Working Group (IMWG) Uniform Response Criteria with the addition of minimal response (MR) based on the European Group for Blood and Marrow Transplant Group (EBMT). Non-Hodgkin lymphoma (NHL) participants were evaluated using the International Workshop NHL criteria. Waldenström macroglobulinemia (WM) participants were evaluated using Criteria from the Sixth International Workshop for WM.~Overall response is defined in Outcome Measure 2 for participants with solid tumors. For NHL, overall response is defined as a best overall response of CR or PR. For multiple myeloma and WM, overall response is defined as participants with a best overall response of stringent complete response (sCR), CR, very good partial response (VGPR) or PR."|Tumor assessments occurred at the end of Cycle 2, 4, 6, 9, and 12 and continued every 3 cycles thereafter up to 6 months after last dose. Analysis includes data up to the data cut-off date of 07 October 2014; maximum duration of treatment was 35 months.|Safety Population||percentage of participants||95% Confidence Interval|Number
132788|NCT00531284|Primary|Phase 2: Percentage of Participants With an Overall Response After 4 Treatment Cycles|"Overall response is defined as participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) after 4 cycles, assessed by the Investigator using tumor measurement and according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.~CR: Disappearance of all target and non-target lesions and no new lesions;~PR: Disappearance of all target lesions, persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits and no lesions, or, at least a 30% decrease in the size of target lesions and no progression of existing non-target lesions or any new lesions.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest size since the treatment started, and no progression of existing non-target lesions or any new lesions."|4 months|Phase 2 Safety population||percentage of participants||95% Confidence Interval|Number
132789|NCT00531284|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities (DLT)|"Participants were evaluated for dose-limiting toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.~A DLT was defined as treatment-related ≥ Grade 2 neuropathy with pain, ≥ Grade 3 non-hematologic toxicity, Grade 4 neutropenia or thrombocytopenia lasting 7 or more days, or thrombocytopenia with bleeding.~The maximum tolerated dose (MTD) for each of the 3 populations (solid tumor, multiple myeloma, and lymphoma) was defined as the dose level at which < 33% of participants experienced a dose-limiting toxicity during the first 28-day cycle."|28 days|Dose-limiting toxicity analysis was based on subsets of the safety population including participants exposed to carfilzomib in Cycle 1 who experienced a DLT or completed 28 days of evaluation after the first dose of carfilzomib. Participants enrolled into the expansion cohorts (MTD dose expansion, carfilzomib + DEX) were not evaluated for DLT.||participants|||Number
132790|NCT00531206|Secondary|Alkaline Phosphatase Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
132791|NCT00531206|Secondary|Total Bilirubin Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
132792|NCT00531206|Secondary|Creatinine Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
132793|NCT00531206|Secondary|Gamma-glutamyl Transpeptidase (GGT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
132794|NCT00531206|Secondary|Aspartate Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
132795|NCT00531206|Secondary|Alanine Aminotransferase (ALT) Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||international units/liter||Inter-Quartile Range|Median
132796|NCT00531206|Secondary|Triglycerides Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
132797|NCT00531206|Secondary|Low Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
132798|NCT00531206|Secondary|High Density Lipoprotein (HDL) Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
132799|NCT00531206|Secondary|Total Cholesterol Over Time||52 weeks|Full Analysis Set (FAS), all patients entered and treated||mg/dl||Inter-Quartile Range|Median
132800|NCT00531206|Secondary|Body Mass Index Class (Kilograms/Square Meter)||52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
132801|NCT00531206|Secondary|Use of Lipid Lowering Agents During the Study||52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
132802|NCT00531206|Secondary|Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir||52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
132803|NCT00531206|Secondary|Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
132804|NCT00531206|Secondary|Discontinuations Due to an Adverse Event|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
132805|NCT00531206|Secondary|Deaths|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
132806|NCT00531206|Secondary|Serious Adverse Events|The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.|52 weeks|Full Analysis Set (FAS), all patients entered and treated||Number of patients|||Number
132807|NCT00531206|Secondary|Subjective Well-being|Investigator’s opinion of patient’s general condition (quality of life)|52 weeks|Full Analysis Set (FAS), all patients entered and treated||participants|||Number
132811|NCT00531050|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.|23 hours 30 minutes and 24 hours post-dose at Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Liters||95% Confidence Interval|Least Squares Mean
132812|NCT00531050|Primary|Maximum Heart Rate (HR) During Salbutamol Administration in Part 2|Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.|24 hours post dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate.||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
132813|NCT00531050|Primary|Maximum Heart Rate During Exercise in Part 1|Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.|2 hour post-dose on Day 1|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
132814|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study|"The percentage of patients with an increase of >= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined.~0-12 hours: post first dose measurements up to second dose~12-24 hours: post second dose measurement up to and including the 24 hour measurement~0-24 hours: all post dose measurements up to and including the 24 hour measurement"|24 hours post dose on Day 1|Safety population. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate. In a patient where data for the second 12 hour period is missing, 0-24 is not reported; hence the discrepancy of 4 and 3 subjects.||Percentage of participants||95% Confidence Interval|Number
132815|NCT00531050|Secondary|Change in Heart Rate During Exercise in Part 1|"Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise.~Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate."|1.5 hour post dose to max heart rate during exercise|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
132816|NCT00531050|Primary|Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study|The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.|24-hours post-dose on Day 1 (of each treatment)|The safety population consisted of all subjects who received at least one dose of study medication after randomization.||Percentage of participants||95% Confidence Interval|Number
132817|NCT00531011|Primary|In-stent Late Loss (LL)|Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.|at 270 days|Descriptive statistics for this measure are based on one random lesion per patient, 167 patients performed angiographic follow-up.||millimeters|Participants|Standard Deviation|Mean
132818|NCT00531011|Secondary|Distal Minimum Lumen Diameter (MLD).|Distal refers to the immediate 5 mm outside of the distal end of the stent.|at 9 months.|||millimeters|Participants|Standard Deviation|Mean
132819|NCT00531011|Secondary|Proximal Minimum Lumen Diameter (MLD).|Proximal refers to the immediate 5 mm outside of the proximal end of the stent.|at 9 months.|||millimeters|Participants|Standard Deviation|Mean
132820|NCT00531011|Secondary|In-segment Minimum Lumen Diameter (MLD).||at 9 months.|||millimeters|Participants|Standard Deviation|Mean
132821|NCT00531011|Secondary|In-stent Minimum Lumen Diameter (MLD).||at 9 months.|||millimeters|Participants|Standard Deviation|Mean
132822|NCT00531011|Secondary|Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.||9 months|ITT||percentage of participants|||Number
132823|NCT00531011|Secondary|Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .|ITT|9 months|ITT||percentage of participants|||Number
132824|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|9 months|ITT||percentage of participants|||Number
132825|NCT00531011|Secondary|Revascularizations|(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.|at 30 days|ITT||percentage of participants|||Number
132826|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||9 months|ITT||percentage of participants|||Number
132827|NCT00531011|Secondary|Adjudicated Stent Thrombosis.||at 30 days|||percentage of participants|||Number
132828|NCT00531011|Secondary|Device Success|defined as achievement of a final residual in-stent diameter stenosis of < 30% (visual assessment) using the assigned device only.|at the time of PCI|||percentage of participants|Participants||Number
132829|NCT00531011|Secondary|Procedural Success|defined as: residual in-stent %DS of < 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.|at the time of PCI|||percentage of participants|Participants||Number
132830|NCT00531011|Secondary|Lesion Success|defined as attainment of < 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.|at the time of PCI|Intent to treat (ITT)||Percentage of participants|Participants||Number
132831|NCT00531011|Secondary|Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).||at 30 days|ITT||percentage of participants|||Number
132833|NCT00531011|Secondary|In-segment Late Loss (LL)|LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.|at 9 months|167 patients performed angiographic follow-up. Descriptive statistics for this measure are based on one random lesion per patient.||millimeters|Participants|Standard Deviation|Mean
132834|NCT00531011|Secondary|In-segment Binary Restenosis Rate|"This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges~In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent."|at 9 months|167 patients performed angiographic follow-up.||percentage of participants|Participants||Number
132835|NCT00531011|Secondary|In-stent Binary Restenosis Rate|This measures the percentage of patients who have > 50% diameter stenosis of the assessed vessel, within the stent edges.|at 9 months|ITT, 167 patients performed angiographic follow-up.||percentage of participants|Participants||Number
132836|NCT00530946|Secondary|Change in Apolipoprotein B From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases||mg/dL||Standard Deviation|Mean
132837|NCT00530946|Secondary|Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Ratio||Standard Deviation|Mean
132838|NCT00530946|Secondary|Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases||Ratio||Standard Deviation|Mean
132839|NCT00530946|Secondary|Percent Change in Triglycerides From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
132840|NCT00530946|Secondary|Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
132841|NCT00530946|Secondary|Percent Change in Total Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
132842|NCT00530946|Secondary|Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point|"Percent of value at Week 2, Week 4, or Week 8 minus value at baseline over value at baseline"|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||Percent Change||Standard Deviation|Mean
132843|NCT00530946|Secondary|Change in Diastolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks , and 8 weeks|Full Analysis Set, Observed Cases||mm Hg||Standard Deviation|Mean
132844|NCT00530946|Secondary|Change in Systolic Blood Pressure From Baseline to Each Observation Point|Value at Week 2, Week 4, or Week 8 minus value at baseline|2 weeks, 4 weeks, and 8 weeks|Full Analysis Set, Observed Cases||mm Hg||Standard Deviation|Mean
132845|NCT00530946|Primary|Percent Change in Low Density Lipoprotein-Cholesterol|"Percent of value at Week 8 minus value at baseline over value at baseline"|8 weeks|Full Analysis Set, Last Observation Carried Forward||Percent Change||Standard Error|Least Squares Mean
132846|NCT00530946|Primary|Change in Systolic Blood Pressure|Value at Week 8 minus value at baseline|8 weeks|Full Analysis Set, Last Observation Carried Forward||mm Hg||Standard Error|Least Squares Mean
132847|NCT00530920|Secondary|Clinical Abnormal Findings in Laboratory and Physical Examination||Screening through the end of the study (14 days)|Treated set.||participants|||Number
132848|NCT00530920|Secondary|Cmax of Ritonavir|Ritonavir pharmacokinetics|Visits baseline, 5, 7, 9 and 13 or 14|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
132849|NCT00530920|Secondary|Tmax of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h||Geometric Coefficient of Variation|Geometric Mean
132850|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||Hours||Geometric Coefficient of Variation|Geometric Mean
132851|NCT00530920|Secondary|Volume of Distribution (V/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L||Geometric Coefficient of Variation|Geometric Mean
132852|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Ritonavir|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L/h||Geometric Coefficient of Variation|Geometric Mean
132853|NCT00530920|Secondary|Cp 24 h of Ritonavir for QD and CP 12 h of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
132854|NCT00530920|Secondary|AUC 24 of Ritonavir for QD and AUC 12 of Ritonavir for BID|Ritonavir pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h*uM||Geometric Coefficient of Variation|Geometric Mean
132855|NCT00530920|Secondary|Time to Cmax (Tmax) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h||Geometric Coefficient of Variation|Geometric Mean
132856|NCT00530920|Secondary|Terminal Half-Life (t1/2) of Tipranavir|Tipranavir pharmacokinetics|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h||Geometric Coefficient of Variation|Geometric Mean
132860|NCT00530920|Secondary|Concentration-24 Hour (hr) Post Dose of Tipranavir - (Cp 24 h for QD and 12 hr Post Dose (CP 12h) for BID|TPV pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||uM||Geometric Coefficient of Variation|Geometric Mean
132861|NCT00530920|Secondary|Area Under the Curve(AUC) of Tipranavir 24 h for Once Daily (QD) and AUC 12 h for Twice Daily (BID)|Tipranavir (TPV) pharmacokinetics|Final (Day 13 for QD, Day 14 for BID)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||h*uM||Geometric Coefficient of Variation|Geometric Mean
132862|NCT00530920|Secondary|Apparent Oral Clearance I(Cl/F) of Tipranavir|"Tipranavir pharmacokinetics - Clearance (CL) is defined as the dose of a drug divided by the area-under-the-concentration-time curve (AUC), ie. CL = Dose / AUC. For extravascu­lar models the fraction of dose absorbed cannot be estimated, therefore clear­ance for these models is actually Cl/F where F is the fraction of the drug dose which is absorbed."|Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||L/h||Geometric Coefficient of Variation|Geometric Mean
132863|NCT00530920|Primary|Viral Load (log10 Copies/mL) Change From Baseline (Last Observation Carried Forward (LOCF))||Baseline (Day 0) to Final (Day 14)|Treated Set, includes all patients that were randomized and were documented to have received at least one dose of investigational treatment||Log10 copies/mL||Inter-Quartile Range|Median
132864|NCT00530855|Secondary|Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study||From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||Participants|||Number
132865|NCT00530855|Secondary|Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design)."|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||Participants|||Number
132866|NCT00530855|Primary|Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study|Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||days||Standard Deviation|Mean
132867|NCT00530855|Primary|Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study|Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.|From Visit 1 to End of Study (approximately 2 years)|All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.||Participants|||Number
132868|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none)|8 weeks|FAS using imputed values||Participants|||Number
132869|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none)|4 weeks|FAS using imputed values||Participants|||Number
132870|NCT00530842|Secondary|Locus of Symptom Limitation at Peak Exercise During Exercise|Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none)|baseline|FAS using imputed values||Participants|||Number
132871|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values||Unit on a Scale||Standard Deviation|Mean
132872|NCT00530842|Secondary|Dyspnea and Leg Discomfort|Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10)|8 weeks|FAS using imputed values||Unit on a Scale||Standard Deviation|Mean
132873|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|4 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
132874|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort|8 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
132875|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|4 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
132876|NCT00530842|Secondary|Symptom Intensity During Exercise|Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea|8 weeks|FAS using imputed values||Unit on a Scale||Standard Error|Mean
132877|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
132878|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
132879|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
132880|NCT00530842|Secondary|FEV1 Over FVC (Percent)|Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of FEV1 over FVC||Standard Error|Mean
132888|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Percent of predicted FEV1||Standard Error|Mean
132889|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132890|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132891|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132892|NCT00530842|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132893|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132894|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132895|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132896|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132897|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
132898|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
132899|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
132900|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of TGV over TLC||Standard Error|Mean
132901|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
132902|NCT00530842|Secondary|Static Lung Volumes (Percent)|Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
132903|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
132904|NCT00530842|Secondary|Static Lung Volumes (Percent)|Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Percent of RV over TLC||Standard Error|Mean
132905|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132906|NCT00530842|Secondary|Static Lung Volumes|Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132907|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132908|NCT00530842|Secondary|Static Lung Volumes|Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132909|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132910|NCT00530842|Secondary|Static Lung Volumes|Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132911|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132912|NCT00530842|Secondary|Static Lung Volumes|Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132913|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132914|NCT00530842|Secondary|Static Lung Volumes|Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132915|NCT00530842|Secondary|Static Lung Volumes|Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132916|NCT00530842|Secondary|Static Lung Volumes|Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132917|NCT00530842|Secondary|Static Lung Volumes|Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132918|NCT00530842|Secondary|Static Lung Volumes|Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132919|NCT00530842|Secondary|Static Lung Volumes|Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography)|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132920|NCT00530842|Secondary|Static Lung Volumes|Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography)|8 weeks|FAS using imputed values||Litres||Standard Error|Mean
132923|NCT00530842|Secondary|Endurance Time (After 4 Weeks)|Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|4 weeks|FAS using imputed values||Seconds||Inter-Quartile Range|Median
132924|NCT00530842|Secondary|Post-dose TGV(FRC) (After 4 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks|4 weeks|FAS using imputed values||Litres||Standard Error|Mean
132925|NCT00530842|Primary|Endurance Time (After 8 Weeks)|Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)|8 weeks|FAS using imputed values||Seconds||Inter-Quartile Range|Median
132926|NCT00530842|Primary|Post-dose TGV(FRC) (After 8 Weeks)|Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks|8 weeks|FAS using imputed values. The full analysis set (FAS) was defined to include all treated patients with any post-dosing efficacy data after at least 4 weeks for both investigational treatments in TGV(FRC) or endurance time.||Litres||Standard Error|Mean
132927|NCT00530816|Secondary|Overall Survival (OS)|"Overall Survival is defined as the time from the start of study treatment to date of death due to any cause.~Patients who were alive or lost to follow-up as of the data analysis cut-off date for the final OS analysis were censored at the date the patient was last known to be alive. Median OS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 19 November 2012 for Part 1 and 07 January 2013 for Part 2. Median follow-up time was 19.1 months for Part 1 and 35.9 months in Part 2.|Safety Population includes all patients enrolled on study and who received at least 1 dose of carfilzomib.||months||95% Confidence Interval|Median
132928|NCT00530816|Secondary|Progression-free Survival (PFS)|"Progression-free Survival (PFS) is defined as the time from start of treatment to IRC determined disease progression or death due to any cause. Patients who were lost to follow-up prior to documentation of disease progression and patients who were alive without disease progression before a data analysis cut-off date were censored at the last disease assessment.~Median PFS was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population||months||95% Confidence Interval|Median
132929|NCT00530816|Secondary|Time to Progression (TTP)|"Time to Progression is defined as the time from the start of treatment to IRC-determined disease progression. Patients who were lost to follow-up prior to documentation of disease progression, or who died before documentation of disease progression or who were alive and did not have documentation of disease progression before the data analysis cut-off date were censored at the last disease assessment.~Median TTP was estimated using the Kaplan-Meier method."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.|Response Evaluable Population||months||95% Confidence Interval|Median
132930|NCT00530816|Secondary|Duration of Response (DOR)|"DOR is defined as the time from first evidence of PR or better to disease progression assessed by the IRC or death due to any cause. Patients lost to follow-up prior to disease progression or who were alive without disease progression before the analysis cutoff date were censored at the last disease assessment.~Progressive disease was defined as any of the following:~An increase of M-protein in serum (absolute increase ≥ 0.5 g/dL) or urine (absolute increase ≥ 200 mg/24 hours) of > 25% from the nadir (if not zero).~Percentage of plasma cells in bone marrow ≥ 10%.~New or increased size of bone lesions or new plasmacytomas.~Patients without measurable serum and urine M-protein: 25% increase from nadir in the difference between involved and uninvolved FLC levels and absolute increase >10 mg/dL.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) attributed solely to the proliferative disorder.~Median DOR was estimated using Kaplan-Meier methods."|Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2.|Response Evaluable Population with a response of PR or better.||months||95% Confidence Interval|Median
132931|NCT00530816|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is defined as the percentage of participants with a best overall response of minimal response (MR) or better, i.e., a best overall response of sCR, CR, VGPR, PR, or MR. MR was defined as outlined by European Group for Blood and Marrow Transplantation (EBMT) criteria, defined as reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89%, maintained for 6 weeks.|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|Response Evaluable Population||percentage of participants||95% Confidence Interval|Median
132932|NCT00530816|Secondary|Best Overall Response Rate (ORR) in the Response Evaluable Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.~sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.~CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.~VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.~PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, End of Study, 30 days after last dose; median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|The Response Evaluable population consists of all treated patients with measurable disease at Baseline as assessed by M-protein, SFLC or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.||percentage of participants||95% Confidence Interval|Number
132944|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score|The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47|Baseline and Week 12/EW|Full Analysis Set(FAS)||Points on a scale||Standard Deviation|Mean
132933|NCT00530816|Primary|Best Overall Response Rate (ORR) in the Response Evaluable Subset Population|"ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy.~sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.~CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow.~VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level < 100 mg/24 hours.~PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to < 200 mg per 24 hours."|Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.|"The Response Evaluable Subset population consists of all treated patients with measurable disease at Baseline as assessed by M-protein or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment.~Patients whose disease was only measurable by SFLC were excluded."||percentage of participants||95% Confidence Interval|Number
132934|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|PK Population||picograms/mL||Standard Deviation|Mean
132935|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1 -12|PK Population||picograms/mL||Standard Deviation|Mean
132936|NCT00530790|Secondary|Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.|Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.|Weeks 1-12|Pharmacokinetic (PK) Population: subjects who underwent blood sampling for measuring the trough plasma drug concentrations, excluding those who did not fulfill inclusion criteria, those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.||picograms/mL||Standard Deviation|Mean
132937|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)|"Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety 0-21 and seven for depression 0-21. Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation."|Baseline - Week 12/EW|FAS: Subpopulation: HADS Anxiety population, N = 15; HADS Depression population, N = 31. Patients in the FAS population who also have a baseline anxiety domain score of 8 or greater and patients with a baseline depression domain score of 8 or greater will be included in the HADS Anxiety Population and the HADS Depression Population, respectively.||Points on a scale||Standard Deviation|Mean
132938|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)|"The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from Not at all (0) to Extremely (4). The assessment measures six identified mood factors:~Tension-Anxiety~Depression-Dejection~Anger-Hostility~Vigor-Activity~Fatigue-Inertia~Confusion-Bewilderment"|Baseline and Week 12/EW|Full Analysis Set||Points on a scale||Standard Deviation|Mean
132939|NCT00530790|Primary|Vital Signs and Body Weight Change From Baseline|Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.|Baseline to Week 12/EW|Safety Population||Varied Standard Units of Measure||Standard Deviation|Mean
132940|NCT00530790|Primary|12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline, Week 4, 8, 12, 13 (Follow-up)|Safety Population - (Baseline = 35 subjects, Week 4 = 33 subjects, Week 8 = 31 subjects, Week 12/EW = 33 subjects and Week 13 [Follow-up] = 35 subjects evaluated).||Participants|||Number
132941|NCT00530790|Primary|Urinalysis Clinical Lab Values|Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.|Baseline - Week 13 (Follow-up)|Safety Population (Baseline, Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 [Follow-up] = 35 subjects evaluated).||Participants|||Number
132942|NCT00530790|Primary|Blood Chemistry Clinical Lab Values Change From Baseline|Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).||Varied Standard Units of Measure||Standard Deviation|Mean
132943|NCT00530790|Primary|Haematology Clinical Lab Values Change From Baseline|Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.|Baseline - Week 13 (Follow-up)|Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).||Varied Standard Units of Measure||Standard Deviation|Mean
136867|NCT00498368|Primary|Change in Proteinuria at 12 Months||1 year|The number of participants differs from the participant flow because not all participants had the laboratory test done.||participants|||Number
132945|NCT00530790|Secondary|Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0–21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)||Points on a scale||Standard Deviation|Mean
132946|NCT00530790|Secondary|Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0–21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.|Baseline - Week 12/EW|Full Analysis Set(FAS)||Points on a scale||Standard Deviation|Mean
132947|NCT00530790|Secondary|Clinical Global Impression Global Improvement (CGI-GI)|CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).|Baseline - Final assessment point|Full Analysis Set Population (Weeks 1, 2, 3, and 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Week 10, 12 = 30 subjects; Final assessment point = 35 subjects). Method for missing date is LOCF.||Participants|||Number
132948|NCT00530790|Secondary|Clinical Global Impression Scale - Severity of Illness (CGI-S)|The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).|Baseline - Final assessment point|Full Analysis Set Population (Baseline, Weeks 1, 2, 3, 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Weeks 10 and 12 = 30 subjects; Final assessment point = 35 subjects). Method of Missing Data = LOCF.||Participants|||Number
132949|NCT00530790|Secondary|Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score|The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.|Baseline and after Week 12|Full Analysis Set: Subjects entered to the treatment period, except for those not fulfilling the major registration criteria, those who did not take even one dose of the study medication, and those for whom no observation data were available after starting the study treatment. Method for missing data is Last Observation Carried Forward (LOCF).||Points on a scale||Standard Deviation|Mean
132950|NCT00530790|Primary|Drug Related Adverse Events-On-Therapy||Weeks 1 - 12 Treatment Period|Safety Population consisting of the subjects who took at least one dose of the study medication.||Number of Events|||Number
132951|NCT00530777|Secondary|Vertical HIV-1 Transmission||1 year postpartum|||Participants|||Number
132952|NCT00530777|Primary|Mean Change in HIV-1 Levels in Plasma Between 34 and 38 Weeks Gestation||4 weeks|Women with paired plasma samples at 34 and 38 weeks gestation||log10 copies/mL||Standard Deviation|Mean
132953|NCT00530764|Secondary|Change in Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression.|Baseline and End of Treatment (Week 5 or premature termination)|||Score on scale||Standard Deviation|Mean
132954|NCT00530764|Secondary|Change in Patient Global Impression of Change - PGIC|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to cancer since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|End of Week 5|||Participants|||Number
132955|NCT00530764|Secondary|Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)|The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement.|Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)|||Score on scale||Standard Deviation|Mean
132956|NCT00530764|Secondary|Change in Brief Pain Inventory – Short Form (BPI-SF)|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). the minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)|||Score on scale||Standard Deviation|Mean
132957|NCT00530764|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)|||Points on scale||Standard Deviation|Mean
132958|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Worst Pain).|"The worst pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your worst pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in worst pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)|||Points on scale||Standard Deviation|Mean
136868|NCT00498355|Secondary|The Incidence of Ocular and Non-ocular Adverse Events||Study duration||||||
132959|NCT00530764|Secondary|Change in Mean Daily NRS Pain Score (Average Pain).|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline."|5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)|||Points on scale||Standard Deviation|Mean
132960|NCT00530764|Secondary|Change in Cumulative Average Pain Response Curves|"The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response.~The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer."|Baseline to end of treatment (Week 5)|||Percent Change||Inter-Quartile Range|Median
132961|NCT00530764|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening."|5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)|||Participants|||Number
132962|NCT00530712|Secondary|Duplex Ultrasound ≤ 2.4 Primary Patency|Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year|||Event free percentage||95% Confidence Interval|Number
132963|NCT00530712|Secondary|Walking Improvement||1 Year||||||
132964|NCT00530712|Secondary|Absolute Claudication Distance Improvement|Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined.|1 Year|||Miles||Standard Deviation|Mean
132965|NCT00530712|Secondary|Secondary Patency|Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects.|1 Year|||Event free percentage||95% Confidence Interval|Number
132966|NCT00530712|Secondary|Assisted Primary Patency|Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects.|1 Year|||Event free percentage||95% Confidence Interval|Number
132967|NCT00530712|Secondary|Increase in Ankle-Brachial Index|Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.|1 Year|||Ratio||Standard Deviation|Mean
132968|NCT00530712|Secondary|Improvement in Rutherford Clinical Category|Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline.|1 Year|||Percentage of participants with data|||Number
132969|NCT00530712|Secondary|Decline in Rutherford Clinical Category|Defined as an increase of one or more categories in RCC compared to baseline.|30 Days||||||
132970|NCT00530712|Secondary|Stent Fracture Rate|Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. only 1 year data presented here.|1, 2 and 3 Years|||percentage of stents implanted|Participants||Number
132971|NCT00530712|Secondary|Major Adverse Events|MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC.|1 Year|||Percentage of particants with data|||Number
132972|NCT00530712|Secondary|Single-Stent Major Adverse Events|MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects.|30 Days|||Percentage of participants with data|||Number
132973|NCT00530712|Secondary|Single-Stent Primary Patency|Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject.|1 Year|||Percentage of participants with data|||Number
132974|NCT00530712|Primary|Major Adverse Events|Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC)|30 Days|||Percentage of participants with data|||Number
132975|NCT00530712|Primary|Primary Patency|Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure.|1 Year|||Percentage of participants with data|||Number
132976|NCT00530634|Primary|Two-year Progression-free Survival From the Date of Surgery|Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 25% increase or an increase of 10 cm2 (whichever is smaller) in the sum of the products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation or death, or deteriorating condition (unless clearly unrelated to this cancer).|2 years post-surgery|Study was terminated after accruing only three patients.||percentage of participants||95% Confidence Interval|Number
132994|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study|Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).|over 8 weeks|All enrolled participants.||participants|||Number
132977|NCT00530504|Primary|Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.|Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.|30 Days|||participants|||Number
132978|NCT00530439|Primary|Gestational Weight Gain|Weight at gestational week 35 - weight by inclusion|Gestational week 35|||kg||Inter-Quartile Range|Median
132979|NCT00530439|Secondary|Metabolic Markers||Until 6 months post partum||||||
132980|NCT00530439|Primary|Neonatal Intensive Care Unit||Within 1 month postpartum||||||
132981|NCT00530439|Primary|Large for Gestational Age||Delivery||||||
132982|NCT00530439|Primary|Gestational Diabetes Mellitus||Delivery||||||
132983|NCT00530439|Primary|Preeclampsia/Pregnancy Induced Hypertension||Delivery||||||
132984|NCT00530439|Primary|Cesarean Section||At delivery||||||
132985|NCT00530348|Secondary|Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2|Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years – lesion volume at Baseline)*100/ (lesion volume at Baseline).|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2).||percent change||Standard Deviation|Mean
132986|NCT00530348|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2|MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2).||Z-score||Standard Deviation|Mean
132987|NCT00530348|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.|Baseline, Year 2|FAS population included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2).||units on a scale||Standard Deviation|Mean
132988|NCT00530348|Secondary|Percentage of Participants Who Were Relapse Free at Year 2|Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.|Year 2|FAS population included all randomized participants who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
132989|NCT00530348|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.||relapses per participant per year||95% Confidence Interval|Number
132990|NCT00530348|Primary|Percentage of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least next 2 scheduled assessments, that is, 6 consecutive months. Onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 2 years|FAS population included all randomized participants who received at least 1 dose of study drug.||percentage of participants with SAD||95% Confidence Interval|Number
132991|NCT00530335|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.|8 weeks|||participants|||Number
132992|NCT00530335|Secondary|Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion|The Fridericia correction of the QT interval(QTcF) was used.|over 8 weeks|All enrolled participants.||participants|||Number
132993|NCT00530335|Secondary|Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study|Potentially clinically significant weight loss was defined as any decrease of at least 7%. Potentially clinically significant weight gain was defined as any increase of at least 7%.|over 8 weeks|All enrolled participants.||participants|||Number
136869|NCT00498355|Secondary|The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous)||Study duration||||||
132995|NCT00530335|Secondary|Change From Endpoint to Baseline in Stroop Color Word Test|An assessment of response inhibition. Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink. There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||number of correct answers||Standard Deviation|Mean
132996|NCT00530335|Secondary|Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores|"Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales.~Calculate: norm-based score=Z-score*10+50 in each subscale."|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
132997|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (normal) to 56 (severe).|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
132998|NCT00530335|Secondary|Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
132999|NCT00530335|Secondary|Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
133000|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
133001|NCT00530335|Secondary|Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)|Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.|baseline and 8 weeks|All enrolled participants with Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
133002|NCT00530335|Primary|Number of Participants With Adverse Events Leading to Discontinuation||over 8 weeks|All three participants who discontinued due to an adverse event were on atomoxetine doses of between 80 mg/day and 105 mg/day.||participants|||Number
133003|NCT00530270|Secondary|Duration of Hypoxemia (Low Blood Oxygen)|Sum of time periods when subject was hypoxemic (Sp02 value less than 92%) since the first dose date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.||Hours||Standard Deviation|Mean
133004|NCT00530270|Secondary|Duration of Supplemental Oxygen|Time period between the supplemental oxygen start date/time and first dose date/time, whichever is later, and the supplemental oxygen stop date/time|Measured at the end of hospital stay|Subject without major protocol violation and received treatment.||Hours||Standard Deviation|Mean
133005|NCT00530270|Secondary|Duration of Hospitalization|Duration in hours from treatment start time to hospital discharge.|Measured at the end of hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.||Hours||Standard Deviation|Mean
133006|NCT00530270|Secondary|Rating of Pain|Change from baseline rating of pain from randomization (baseline) to discharge from the hospital, evaluated every 4 hours. Pain was rated on the Oucher Scale for the pediatric population or numeric rating scale for the adult population, both 0 to 10 with 0 indicating no pain and 10 indicating severe pain.|Measured at the end of the hospital stay|Subject without major protocol violation and received treatment.||Units on a scale||Standard Error|Mean
133007|NCT00530270|Primary|Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less|Resolution of symptoms of ACS includes respiratory rate <= upper limit of normal +2, no work of breathing (retractions, nasal flaring, and use of accessory muscles), thoracic pain <= 4, no use of supplemental oxygen, no use of ventilary support, and saturation of peripheral oxygen (Sp02) >= steady state value -2. Symptoms were measured every 4 hours from the first dose of study drug to resolution of symptoms or hospital discharge.|Measured from first dose to end of the hospital stay, no maximum number of days|Subject without major protocol violation and received treatment.||hours (log transformed)||Standard Deviation|Log Mean
133008|NCT00530257|Primary|Test of Everyday Attention for Children: Opposite Worlds|The TEA-Ch is a battery of subtests designed to assess multiple attentional capacities in children 6-16y.o. The Opposite Worlds subtest is a measure of attentional control and response inhibition. There is not a finite range of scores on this test. Lower scores indicate better performance..|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
133009|NCT00530257|Primary|Test of Everyday Attention for Children: Sky Search|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search subtest is a measure of selective attention. There is not a finite range of scores on this subtest, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
136870|NCT00498355|Secondary|The Mean Change in Area of Leakage From Baseline at 3 and 12 Months||3 and 12 months||||||
133010|NCT00530257|Primary|Test of Everyday Attention for Children: Map Mission|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
133011|NCT00530257|Primary|Test of Everyday Attention for Children: Creature Counting|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Creature Counting subtest is a measure of attentional control. There is not a finite range for this test, but lower scores indicate better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
133012|NCT00530257|Primary|Test of Everyday Attention for Children: Score Dual Task (DT)|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Score DT subtest is a measure of sustained attention. and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
133013|NCT00530257|Primary|Test of Everyday Attention for Children-Sky Search Dual Task|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Sky Search Dual Task is a measure of sustained attention. Lower scores indicate better performance. There is not a finite range for this test and very high scores can be negative numbers.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
133014|NCT00530257|Other Pre-specified|Stimulant Side Effect Rating Scale|Parents rate 16 possible stimulant side effects on a 10 point likert scale from 0-9 with 0 indicating no side effects and 9 indicating more severe symptoms.|2 weeks|||Units on a scale||Standard Deviation|Mean
133015|NCT00530257|Secondary|ADHD Rating Scale-IV, Parent and Teacher Version|This is the parent and teacher version of the ADHD Rating Scale-IV. The scale has 2 subscales, one for inattention and one for hyperactivity-impulsivity. The scores provided are percentile scores and can range from 1 to 99 percent. Higher scores indicate more problems in inattention or with hyperactivity-impulsivity|2 Weeks|We had complete data for all 30 subjects for the parent rating scale. We only had 24 sets of complete data for the teacher rating scale as some teachers did not return a rating scale when the subject was on both medication and placebo||Percentile||Standard Deviation|Mean
133016|NCT00530257|Secondary|Behavior Rating Inventory of Executive Function||2 Weeks|Although this was included in the protocol we have not analyzed the results of this rating scale||units on a scale||Standard Deviation|Mean
133017|NCT00530257|Primary|Wechsler Intelligence Scale for Children-IV, Digit Span Subtest|The verbal assessment of working memory uses the digit span reversed component of the Digit Span subtest of the Wechsler Intelligence Scale for Children-IV edition (WISC-IV).Scores could range from 0 to 16 with higher scores indicating better performance.|2 weeks|The 30 subjects who completed both arms of the crossover analysis||units on a scale||Full Range|Median
133018|NCT00530257|Primary|Gordon Diagnostic System Continuous Performance Test|This is a measure of sustained attention & response inhibition for children 6 yrs and older. During this task a series of numbers flash, one at a time, on a screen. The subject is told to press a button every time a “1” is followed by a “9”. There are 45 possible correct responses over the 9-minute task. Omission errors are a measure of sustained attention and can range from 0 to 45. Commission errors are a measure of sustained attention and response inhibition can range from zero to hundreds (each time the button is pushed at the incorrect time). Lower scores indicate better performance.|2 weeks|31 participants began the crossover phase of the trial and 30 completed both the medication and placebo arms. For one patient there was an equipment problem so that subject did not have data available||errors||Full Range|Median
133019|NCT00530257|Primary|Test of Everyday Attention for Children: Walk, Don't Walk|The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Walk-Don’t Walk subtest is a measure of sustained attention and response inhibition. Scores on this subtest can range from 0 to 20 with higher scores representing better performance.|2 weeks|Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed||units on a scale||Full Range|Median
133020|NCT00530088|Primary|Local Toxicity|Number of patients with an adverse event|30 days|All treated and eligible patients||participants|||Number
133021|NCT00530088|Primary|Response|"Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy.~9.23 No Response. All responses less than a Partial Response are considered as No Response.~9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia."|2 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
133022|NCT00530023|Secondary|Hypoglycemia Fear Scale (HFS) Assessed at Baseline and Week 15|Questionnaire evaluating change in the subjects' fear of potential hypoglycemia events assessed Week 15 and compared between arms. Likert scale of 0 - 4 used with responses graded as the lowest number being the most acceptable and highest number the least acceptable. The questionnaire has two sections, Behavior and Worry with a maximum possible score of 60 for Behavior (15 X 4) and 72 for Worry (18 X 4). The total combined scoring of these two sections was then assessed at Baseline and Week 15 and the change from Baseline to Week 15 for each arm reported as the end of study result.|Baseline and 15 weeks|||Scores on a scale||Standard Deviation|Mean
133035|NCT00529789|Secondary|Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose|Plasma samples were obtained at steady state, and approximately 95% of duloxetine concentrations were within the 24 hour dosing interval.|Weeks 2, 4, 6, 8, 10, 14, 18|Number of patients in each duloxetine dose.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
133023|NCT00530023|Secondary|Insulin Delivery System - Ratings Questionnaire (IDS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant insulin delivery system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks|||Scores on a scale||Standard Deviation|Mean
133024|NCT00530023|Secondary|Blood Glucose Monitoring System - Ratings Questionnaire (BGMS-RQ) Assessed at Baseline and Week 15|Questionnaire measuring overall satisfaction with the relevant blood glucose monitoring system. Assessed at Baseline and Week 15 and compared between arms. Likert scale used with responses graded as the lowest number being the least acceptable and the highest number the most acceptable. The scoring was then transformed to a 0 - 100 scale again with the higher number representing the most acceptable response.|Baseline and 15 weeks|||Scores on a scale||Standard Deviation|Mean
133025|NCT00530023|Secondary|Incidence of Severe Hypoglycemia Events Baseline to Week 15|The total number of severe hypoglycemia events, defined as episodes requiring assistance from another person (i.e., subject is unable to treat self and requires carbohydrate or glucagon or other resuscitative actions) compared between the two study arms from Baseline to Week 15.|Baseline and 15 weeks|||number of events|||Number
133026|NCT00530023|Primary|Change in A1C From Baseline to Week 15|Change in A1C measured from Baseline to week 15 will be compared. A1C measured as percent of glycated hemoglobin using a standardized assay for all subjects.|Baseline and 15 weeks|||percent glycated hemoglobin||Standard Deviation|Mean
133027|NCT00529789|Other Pre-specified|Adverse Events Leading to Discontinuation|A listing of adverse events leading to discontinuation from the study. Abbreviation in data table: ADHD = Attention-Deficit/Hyperactivity Disorder.|Week 0 (Baseline) to 30 Weeks|All enrolled patients.||participants|||Number
133028|NCT00529789|Primary|Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
133029|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III|Total number of patients with any abnormal post-baseline values, based on all values at scheduled and unscheduled visits. Criteria: High QRS Interval = ≥100 milliseconds (msec); High QTc Bazette's or Fredericia's correction - Female = ≥470 msec; High QTc Bazette's or Fredericia's correction - Male = ≥450 msec.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
133030|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alkaline Phosphatase (>420 Units/Liter [U/L]); Low Hematocrit (females <0.32; males <0.37); High Inorganic Phosphorus (>1.776 millimoles/L).|Between 18 and 30 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values in Period IV, based on all values at scheduled and unscheduled visits.||participants|||Number
133031|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III|The results shown are for all laboratory analytes where PCS criteria were met, based on criteria used for adult studies. Criteria: High Alanine transaminase (>165 Units/Liter [U/L]); High Creatine Phosphokinase (females: >507 U/L; males:>594 U/L); Low Glucose (<2.498 millimoles/L); Low Hematocrit (females: <0.32; males <0.37); Low Hemoglobin (females <5.896 millimoles/L [mmol/L] iron; males <7.137 mmol/L iron); High Inorganic Phosphorus (>1.776 millimoles/L); Low Leukocyte Count (<2.8 X10^9/L).|Baseline to 18 Weeks|Total number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
133032|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Between 18 and 30 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
133033|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.||units on a scale||Standard Deviation|Mean
133034|NCT00529789|Secondary|Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline is the same timepoint (Week 0) for both comparisons, but due to differences in number of patients in both periods (II/III vs IV), the baseline values may be slightly different.|Week 0 (Baseline), 18 Weeks, 30 Weeks|18 Week results are for all enrolled patients with a baseline and at least one non-missing post-baseline value; 30 Week results are for the enrolled patients with a baseline and at least one non-missing post-baseline value in Period IV. Last observation carried forward.||units on a scale||Standard Deviation|Mean
133036|NCT00529789|Primary|Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III|Total number of patients with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Criteria: High Diastolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Systolic Blood Pressure = increase of at least 5 mmHg to a value above the 95th percentile; High Pulse = increase of at least 25 to a value of at least 110.|Baseline to 18 Weeks|Number of patients with baseline (and none abnormal) and post-baseline values, based on all values at scheduled and unscheduled visits.||participants|||Number
133037|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Between 18 and 30 Weeks|Number of enrolled patients with baseline and post-baseline values in Period IV.||participants|||Number
133038|NCT00529789|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Baseline to 18 Weeks|All enrolled patients.||participants|||Number
133039|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period IV|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Week 0 and Between 18 and 30 Weeks|All enrolled patients with data for specified category.||participants|||Number
133040|NCT00529789|Primary|Number of Participants With Emergence of Suicidal Ideation During Period II/III|Emergence of Any Suicidal Ideation: Item 13 of Children's Depression Rating Scale-Revised (CDRS-R) has possible scores of 1 (no thoughts of suicide) to 7 (contemplation of suicide). Emergence of suicidal ideation was defined as an increase in severity of suicidal ideation for those patients who did not have suicidal ideation at baseline (Week 0).|Baseline to 18 weeks|All enrolled patients with data for specified category.||participants|||Number
133041|NCT00529763|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||mL/h||Standard Deviation|Mean
133042|NCT00529763|Secondary|Mean Oral Clearance (CLo) of Dasatinib Following 70 mg BID and 100 QD Dose Administration||Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||mL/h||Standard Deviation|Mean
133043|NCT00529763|Secondary|Mean (AUC[0-T]), (AUC[INF]), and (AUC[TAU])of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-T)for dasatinib. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUC(TAU)=area under the plasma concentration-time curve for a dosing interval|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||ng*h/mL||Standard Deviation|Mean
133044|NCT00529763|Secondary|Mean (Tmax) and (T-Half) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Tmax=time of maximum observed plasma concentration. T-Half=plasma half-life.|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||hours||Standard Deviation|Mean
133045|NCT00529763|Secondary|Mean Maximum Concentration (Cmax) of Dasatinib Following 70 mg BID and 100 QD Dose Administration|Cmax=maximum observed plasma concentration of dasatinib|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose)|Number of treated participants with measurement at time point||ng/mL||Standard Deviation|Mean
133046|NCT00529763|Secondary|Mean Dasatinib Plasma Concentrations|Mean dasatinib plasma concentrations following 70 mg BID dose in AD CML or Ph+ ALL participants and following 100 mg QD dose in CP CML participants|Day 1 (0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose), Days 6 and 7 (0 hours postdose), Day 8 (0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hours postdose),|Number of participants analyzed=all treated participants with evaluable PK data; n=number of participants evaluated at time point||ng/mL||Standard Deviation|Mean
133047|NCT00529763|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Grade 3/4 Hematologic Abnormalities|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|18 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML, AD CML, and Ph+ ALL Participants||Participants|||Number
133068|NCT00529568|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms (kg)||Standard Deviation|Mean
136871|NCT00498355|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12||7 days, and at months 3, 6, 9, and 12||||||
133048|NCT00529763|Secondary|Progression-free Survival Among AD CML and Ph+ ALL Participants|The probability to progress after 12 months among AD CML and Ph+ ALL participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All AD CML and Ph+ ALL Participants. Subjects who neither progressed nor died were censored on the date of their last hematologic or cytogenetic assessment.||percentage (probability)||95% Confidence Interval|Number
133049|NCT00529763|Secondary|Duration of MaHR Among AD CML and Ph+ ALL Participants|Durability of MaHR, as measured by the probability of duration of MaHR > 12 months. Major HR (MAHR) includes CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 and <100,000/mm3; ANC >500/mm3 and <1,000/mm3.|Duration of MaHR was measured for AD CML and Ph+ ALL subjects with MaHR from the first day all criteria were met for MaHR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.||percentage (probability)||95% Confidence Interval|Number
133050|NCT00529763|Secondary|Duration of CHR Among AD CML and Ph+ ALL Participants|Durability of CHR, as measured by the probability of duration of CHR >12 months. CHR=white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils and <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly.|Duration of CHR was measured for AD CML and Ph+ ALL subjects with CHR from the first day all criteria were met for CHR until the date of disease progression (PD) or death.(data cut-off date: 18-Jun-2010)|Number of responders. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment||percentage (probability)||95% Confidence Interval|Number
133051|NCT00529763|Secondary|Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL)|Median time to CHR and MaHR, in weeks. Time to CHR is defined for AD CML and Ph+ALL subjects as the time from first dose of Dasatinib until the first day CHR criteria are met (for all confirmed responses). Time to CHR is computed only for subjects whose best response is CHR. Major HR (MaHR) includes CHR or no evidence of leukemia (NEL). See Outcome Measure 1 for definitions of CHR and MaHR.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|Number of Participants Analyzed=All treated participants. n= number of responders.||weeks||Full Range|Median
133052|NCT00529763|Secondary|Progression-free Survival Among CP CML Participants|The probability to progress after 12 months among CP CML participants. Participants were considered as having Disease Progression (PD) if they: achieved a hematologic response but subsequently no longer meet the criteria consistently on all assessment over a consecutive 2-week period after starting maximum dose; had no decrease from their baseline percent blasts in PB or BM on all assessments over a 4-week period, or had an increase by at least 50% in PB blast count (absolute) over a 2-week period after starting their maximum (individually-tolerated) dose.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All CP CML Participants.Subjects who did not progress nor died were censored at their last tumor assessments.||percentage (probability)||95% Confidence Interval|Number
133053|NCT00529763|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|The Durability of MCyR as measured by the probability of duration of MCyR >12 months. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|Duration of MCyR was measured for CP CML subjects with MCyR from the first day all criteria were met for CCyR or PCyR until the date of disease progression (PD) or death. (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders. Subjects who did not progress nor died were censored at their last tumor assessments.||percentage (probability)||95% Confidence Interval|Number
133054|NCT00529763|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants|Time to MCyR is defined for CP CML subjects with MCyR as the time from first dose of dasatinib until the first day criteria for CCyR or PCyR, whichever occurs first. Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in BM) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in BM).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort who were responders.||weeks||Full Range|Median
133055|NCT00529763|Secondary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR)|For CP CML, a Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; < 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort||percentage of participants||95% Confidence Interval|Number
133069|NCT00529568|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||beats per minute||Standard Deviation|Mean
133858|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 80 weeks|||seconds||95% Confidence Interval|Least Squares Mean
133056|NCT00529763|Primary|Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Subjects (Ph+ ALL)|MaHR=CHR or no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, <20% basophils & <5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 & <100,000/mm3; ANC >500/mm3 & <1,000/mm3. OHR=CHR+NEL+ return to chronic phase (RTC=<15% blasts in BM and PB; <30% blasts+promyelocytes in BM & PB; <20% basophils in PB; no extra-medullar disease other than spleen & liver)|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in these cohorts||percentage of participants||95% Confidence Interval|Number
133057|NCT00529763|Primary|Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow [BM]) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in [BM]).|12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)|All treated participants in this cohort||percentage of participants||95% Confidence Interval|Number
133058|NCT00529659|Secondary|Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score|The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.|Baseline, Month 6|N = Number of patient with at least one non-missing measurement at the time point.||Score on a Scale||Standard Deviation|Mean
133059|NCT00529659|Secondary|Change From Baseline in Stair Climbing Power|"Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says go and ends when both of the patient’s feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time."|Baseline, Month 6|The FAS included all participants that received at least one dose of the study therapy and had a post-randomization stair climbing power measurement.||watts||Standard Deviation|Mean
133060|NCT00529659|Secondary|Change From Baseline in Participant Gait Speed||Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.||cm/sec||Standard Deviation|Mean
133061|NCT00529659|Primary|Change From Baseline in Bilateral Leg Press (BLP) Measurement|BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.||lbs||Standard Deviation|Mean
133062|NCT00529659|Secondary|Change From Baseline in Participant Short Physical Performance Battery (SPPB)|The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.|Baseline, Month 6|N = Number of participants with at least one non-missing measurement at the time point.||Score on a Scale||Standard Deviation|Mean
133063|NCT00529659|Primary|Change From Baseline in Participant Lean Body Mass||Baseline, Month 6|The full analysis set (FAS) included all participants that received at least one dose of the study therapy and had a post-randomization measurement of lean body mass.||kg||Standard Deviation|Mean
133064|NCT00529633|Primary|Difference in Serum Prealbumin|"Serum Prealbumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|Participant data is not available due to no shipping of specimen to analyzing laboratory|||||
133065|NCT00529633|Primary|Difference in Serum CRP|"Serum CRP in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|||Mg/L CRP|||Number
133066|NCT00529633|Primary|Difference in Serum Albumin|"Serum albumin in treated patient and control (no drug) patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety"|28 weeks total|||g/dL of Albumin|||Number
133067|NCT00529568|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
133166|NCT00529217|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.~Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.~= Normal, not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients"|6, 9, or 12 weeks|||responders (CGI-S = 1 or 2)|||Number
133070|NCT00529568|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
133071|NCT00529568|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
133072|NCT00529568|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
133073|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
133074|NCT00529568|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
133075|NCT00529568|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase||participants|||Number
133076|NCT00529568|Secondary|Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.||participants|||Number
133088|NCT00529568|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase||participants|||Number
133077|NCT00529568|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
133078|NCT00529568|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.||participants|||Number
133079|NCT00529568|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.||weeks||Standard Deviation|Mean
133080|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
133081|NCT00529568|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
133082|NCT00529568|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
133083|NCT00529568|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
133084|NCT00529568|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
133085|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.||Gi/L||Full Range|Median
133086|NCT00529568|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Gi/L||Full Range|Median
133087|NCT00529568|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <100 Gi/L. Participants who achieved platelet counts >=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=100 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.||participants|||Number
136872|NCT00498355|Secondary|The Mean Change in Best Corrected Visual Acuity From Baseline at 12 Months||12 months from baseline||||||
133089|NCT00529568|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase||participants|||Number
133090|NCT00529555|Primary|Change in Pocket Depth.|Average change of Pocket Depth at 9 months from baseline|baseline & 9 months|Intent to treat||mm||95% Confidence Interval|Least Squares Mean
133091|NCT00529542|Post-Hoc|Body Mass Index||baseline and 6 weeks|All analyses were performed by intention-to-treat.||kg/m2||Standard Deviation|Mean
133092|NCT00529542|Post-Hoc|Mean Ovarian Volume|Pelvic ultrasound was performed using the 6.5 megahertz (MHz) probe of an ATL 400 machine to characterize ovarian size and morphology. Since in vitro studies demonstrate that statins inhibit ovarian theca-interstitial cell proliferation, we hypothesized that statins might reduce ovarian volume in PCOS.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||mm3||Standard Deviation|Mean
133093|NCT00529542|Post-Hoc|Diastolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mm Hg||Standard Deviation|Mean
133094|NCT00529542|Post-Hoc|Systolic Blood Pressure||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mm Hg||Standard Deviation|Mean
133095|NCT00529542|Other Pre-specified|High-sensitivity C-reactive Protein (hsCRP)|high sensitive C-reactive protein as a measure of inflammation|baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/L||Standard Deviation|Mean
133096|NCT00529542|Secondary|DHEAS|Dehydroepiandrosterone sulfate|baseline and 6 weeks|All analyses were performed by intention-to-treat.||ng/ml||Standard Deviation|Mean
133097|NCT00529542|Secondary|Androstenedione||baseline and 6 weeks|All analyses were performed by intention-to-treat.||ng/ml||Standard Deviation|Mean
133098|NCT00529542|Secondary|Total Testosterone||baseline and 6 weeks|All analyses were performed by intention-to-treat.||ng/dl||Standard Deviation|Mean
133099|NCT00529542|Secondary|AUC for Insulin|Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||uU*minute/mL||Standard Deviation|Mean
133100|NCT00529542|Secondary|Area Under the Curve (AUC) for Glucose During OGTT|A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg*minute/dL||Standard Deviation|Mean
133101|NCT00529542|Secondary|Fasting Insulin||baseline and 6 weeks|All analyses were performed by intention-to-treat.||uU/ml||Standard Deviation|Mean
133102|NCT00529542|Secondary|Fasting Glucose||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
133103|NCT00529542|Secondary|Triglycerides||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
133104|NCT00529542|Secondary|HDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
133105|NCT00529542|Secondary|LDL Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
133106|NCT00529542|Secondary|Total Cholesterol||baseline and 6 weeks|All analyses were performed by intention-to-treat.||mg/dl||Standard Deviation|Mean
133107|NCT00529542|Secondary|Peak Brachial Artery Conductance (BAC)|Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5–12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200–250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200–250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||ml/sec/mm Hg||Standard Deviation|Mean
133108|NCT00529542|Primary|Brachial Artery Flow-mediated Dilation (FMD)|Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.|baseline and 6 weeks|All analyses were performed by intention-to-treat.||% change in brachial artery diameter||Standard Deviation|Mean
133109|NCT00529529|Secondary|Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study|An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. The number of asthma exacerbations includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with “asthma” as a key word in the preferred term.|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Asthma exacerbations||Standard Deviation|Mean
133110|NCT00529529|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85|FEV1 (in liters, L) was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 12, Day 85. The analysis included baseline FEV1 and FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening as covariates.|24 hours post-dose at Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Participants with observations at Day 85 were included in the analysis.||Liters||Standard Error|Least Squares Mean
133593|NCT00526799|Secondary|Clinical Benefit|To determine the rate of clinical benefit defined as the percentage of patients experiencing an objective response or a CA125 response.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely|||percentage of particpants||95% Confidence Interval|Number
133111|NCT00529529|Primary|Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study|A clinically significant asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with systemic corticosteroids. This includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with “asthma” as a key word in the preferred term.|Baseline (Day 1) to end of study (Week 26)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.||Percentage of patients|||Number
133112|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Week 12|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
133113|NCT00529529|Primary|Blood Glucose 1 Hour Post-dose at Day 1|Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
133114|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Week 12|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
133115|NCT00529529|Primary|Serum Potassium 1 Hour Post-dose at Day 1|Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||mmol/L||Standard Error|Least Squares Mean
133116|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 26|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 26 were included in the analysis.||bpm||Standard Error|Least Squares Mean
133117|NCT00529529|Primary|24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12|Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||bpm||Standard Error|Least Squares Mean
133118|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 21|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 21 were included in the analysis.||ms||Standard Error|Least Squares Mean
133119|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||ms||Standard Error|Least Squares Mean
133120|NCT00529529|Primary|Corrected QT (QTc) Interval Using Fridericia’s Formula Measured 1 Hour Post-dose at Day 1|The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||ms||Standard Error|Least Squares Mean
133167|NCT00529217|Primary|Cambridge Depersonalization Scale (CDS)|"Change on CDS from baseline. Scale item number: 29 Item score range: Frequency: 0 - 4, Duration: 0-5 Minimum CDS score: 0 Maximum CDS score: 261~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement."|6, 9, or 12 weeks|||responders (>50% reduction in CDS score)|||Number
133121|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Week 12|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmHg||Standard Error|Least Squares Mean
133122|NCT00529529|Primary|Diastolic Blood Pressure 1 Hour Post-dose at Day 1|Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in this analysis.||mmHg||Standard Error|Least Squares Mean
133123|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Week 12|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12|Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.||mmHg||Standard Error|Least Squares Mean
133124|NCT00529529|Primary|Systolic Blood Pressure 1 Hour Post-dose at Day 1|Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and forced expiratory volume in 1 second (FEV1) pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.|Day 1|Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.||mmHg||Standard Error|Least Squares Mean
133125|NCT00529529|Primary|Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study|Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.|Baseline (Day 1) to end of study (Week 26)|Safety population: All patients who received at least one dose of study drug.||Percentage of patients|||Number
133126|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133127|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133128|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133129|NCT00529516|Secondary|Number of CD8 T-cells (Per Million CD8 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133130|NCT00529516|Secondary|Number of Cluster of Differentiation 8 (CD8) T-cells (Per Million CD8 T-cells) Expressing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD8 T-cells (per million CD8 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD8 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133168|NCT00529204|Secondary|Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes||24 weeks|||adverse events|||Number
133131|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least TNF-α and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133132|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IL-2 and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133133|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least IFN-γ and Another Immune Marker|Results are presented as the geometric mean number of IFN-γ -positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133134|NCT00529516|Secondary|Number of CD4 T-cells (Per Million CD4 T-cells) Producing at Least CD40L and Another Immune Marker|Results are presented as the geometric mean number of CD40L-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Other immune markers assessed include interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133135|NCT00529516|Secondary|Number of Cluster of Differentiation 4 (CD4) T-cells (Per Million CD4 T-cells) Producing at Least 2 Different Immune Markers|Results are presented as the geometric mean number of immune response marker-positive CD4 T-cells (per million CD4 T-cells) for pooled vaccine strains. Immune markers assessed include Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).|At Day 0 and 21|The analysis was performed on the ATP cohort of immunogenicity Cell-Mediated Immunity (CMI) which included a subset of subjects from the ATP Cohort for immunogenicity HI. This included subjects for whom data for immune response marker-positive CD4 result was available 21 days after vaccination.||Cells per million||Standard Deviation|Geometric Mean
133136|NCT00529516|Secondary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to1:40 that is usually accepted as indicating protection. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
133137|NCT00529516|Secondary|Seroconversion Factors for HI Antibodies Against Each of the Three Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI Geometric Mean Titers post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold increase||95% Confidence Interval|Geometric Mean
133138|NCT00529516|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
133139|NCT00529516|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains|Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity haemagglutination-inhibition (HI) which included all evaluable subjects who complied with the protocol up to the end of the active phase, for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
133140|NCT00529516|Secondary|Number of Subjects Reporting Any and Related Medically Significant Conditions (MSCs)|Medically significant conditions assessed include conditions prompting emergency room visits, hospitalizations or physician visits.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||Subjects|||Number
133594|NCT00526799|Secondary|Progression-free Survival|To determine the progression-free survival of patients treated with Sorafenib plus Topotecan.|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely|||months||95% Confidence Interval|Median
133141|NCT00529516|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||Subjects|||Number
133142|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any AE regardless of intensity or relationship to vaccination. Grade 3: AE that prevented normal activity. Related: AE considered by the investigator to be causally related to the study vaccination.|During a 21-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.||Subjects|||Number
133143|NCT00529516|Primary|Duration of Solicited General Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that experienced the specific symptom.||Days||Full Range|Median
133144|NCT00529516|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs)|Solicited general AEs assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 40°C. Related: symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.||Subjects|||Number
133145|NCT00529516|Primary|Duration of Solicited Local Adverse Events|Duration was expressed as the median number of days the symptom was experienced.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that reported the specific symptom.||Days||Full Range|Median
133146|NCT00529516|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.|During a 7-day follow-up period after vaccination|The analysis was performed on the Total Vaccinated Cohort on subjects who completed the symptom sheet.||Subjects|||Number
133147|NCT00529464|Primary|Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP)|A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.|Up to 2 years|The primary outcome measure could not be assessed because no subject received randomized treatment assignment. The study was terminated.|||||
133148|NCT00529451|Primary|Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
133149|NCT00529451|Primary|Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
133150|NCT00529451|Primary|Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)|To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
133151|NCT00529451|Secondary|Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP|To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||Percentage of participants|||Number
133152|NCT00529451|Secondary|Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg|To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg.|Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||Percentage of participants|||Number
133153|NCT00529451|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint|To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension.|Baseline and Week 8|Intent-to-treat. Analyzed patients received at least one dose of study drug and had a post baseline measurement.||mm Hg||Standard Error|Least Squares Mean
133154|NCT00529399|Primary|The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|Based on mixed meal tolerance test (MMTT) conducted at the one year visit|||nmol/L||95% Confidence Interval|Geometric Mean
133155|NCT00529308|Primary|"Number of Patients With Improved or Minimally Improved in Clinical Global Impression-Improvement (CGI) Scale"|The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to “Minimal Improvement,” “Much Improved” or “Very Much Improved,” respectively. CGI-I ratings of “Much” or “Very Much Improved” at post-treatment are used to identify treatment responders.|3 weeks|||participants|||Number
133156|NCT00529308|Primary|Motor Cortex Excitability Normalization-Left Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.||µV||Standard Deviation|Mean
133157|NCT00529308|Primary|"Number of Patients With Much Improved or Very Much Improved on Clinical Global Impression-Improvement (CGI) Scale"|The CGI-I is a clinician-rated scales that have been used in clinical trials for over 25 years. Clinicians rate patient improvement compared to baseline. By convention, 4 = No Change; scores of 5, 6, and 7 move in the direction of worsening; scores of 3, 2, and 1 correspond to “Minimal Improvement,” “Much Improved” or “Very Much Improved,” respectively. CGI-I ratings of “Much” or “Very Much Improved” at post-treatment are used to identify treatment responders.|3 weeks|||participants|||Number
133158|NCT00529308|Primary|Motor Cortex Excitability Normalization-Right Motor Threshold|Motor Threshold (MT) is thought to be a measure of membrane excitability in pyramidal neurons. MT is defined as the minimum magnetic flux needed to elicit a threshold EMG response (50 µV in peak to peak amplitude) in a resting target muscle in 5 out of 10 trials using single pulse TMS administered to the contralateral primary motor cortex. MT for both right and left hand are determined, and the lowest is used to select the intensity for rTMS.|3 weeks|This data was only available for the subjects at the Yale site only.||µV||Standard Deviation|Mean
133159|NCT00529308|Primary|Yale Global Tic Severity Scale (Y-GTSS)|Y-GTSS is a clinician-rated scale used to assess tic severity. Motor and phonic tics are rated separately from 0 to 5 on several scales including number, frequency, intensity, complexity, and interference. Thus Motor and Phonic Tic scores can range from 0 to 25; the combined Total Tic Score ranges from 0 to 50. There is also an Impairment score that rates the overall burden due to tics. The Impairment scale yields a single score from 0 to 50 with higher scores indicating higher levels of overall impairment associated with tics.|3 weeks|||units on a scale||Standard Deviation|Mean
133160|NCT00529282|Secondary|Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.|||||
133161|NCT00529282|Secondary|Clinical Success at 72 Hours|To compare the clinical success rate (absence or improvement of signs and symptoms of infection) at 72 hours after starting ceftobiprole with that of cefepime with or without vancomycin|72 hours after starting study drug|No outcome measures were analyzed due to early termination of the study.|||||
133162|NCT00529282|Secondary|Clinical Cure Regardless of Modification of Therapy|To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the initial course of therapy, regardless of modification of therapy defined as addition of an anti-fungal agent and/or an aminoglycoside. Cure with modification: The subject requires antifungals, which will be considered a failure for the primary endpoint. The subject needs modification of study therapy by adding one or more agents (other than protocol-defined chemoprophylaxis antibiotics).|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.|||||
133163|NCT00529282|Primary|Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.|Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. Cure without modification: A subject will be considered to be cured at the primary efficacy visit if: The subject’s fever and clinical signs and symptoms are resolved to the extent that no further anti-infective therapy is necessary as determined by the investigator Any infecting organisms that were identified at baseline were eradicated|7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.|No outcome measures were analyzed due to early termination of the study.|||||
133164|NCT00529243|Secondary|Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24|To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen.|24 Weeks|Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir.||cells/mm^3||Full Range|Mean
133165|NCT00529243|Primary|Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.|To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen.|24 Weeks|Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir.||participants|||Number
133236|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
133169|NCT00529204|Secondary|Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis|"Steatosis was grades on a scale of 0 (< 5%); 1 (5%- 33%); 2 (> 33% - 66%); and 3 (> 66%).~Inflammation was graded on a scale of 0 (No foci); 1 (< 2 foci per 200 X field); 2 (2-4 foci per 200 X field); and 3 (>4 foci per 200 X field) Fibrosis was graded on a scale of 0 (None); 1 (Mild periportal or perisinusoidal); 2 (Moderate periportal or perisinusoidal); 3 (Bridging fibrosis); and 4 (cirrhosis)"|24 weeks|||units on a scale|||Number
133170|NCT00529204|Primary|Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy||24 weeks|||IU|||Number
133171|NCT00529191|Secondary|•2-hour and 4-hour C-peptide AUC After MMTT. •Hemoglobin A1c •Mean Daily Insulin Dose Per kg Body Weight for 7 Days •Mean Blood Glucose (BG), Number of Preprandial BG > 160 mg/dL or < 70 mg/dL, and Postprandial BG >200 mg/dL|"for the C-peptide AUC measurements collected over a 2 or 4 hour period (with 30 minute intervals)after a Mixed Meal Tolerance Test. The area under the curve from these combined measurements (from 0 to 120 or 0 to 240 minutes) is calculated and the unit of measure is nanogram*minutes/ml.~Mean daily insulin dose is calculated from a logbook maintained by the subjects for one week prior to study visits."|baseline, 1,3,6,9,12,18 months||12/2015||||
133172|NCT00529191|Primary|4-hour C-peptide Area Under the Curve (AUC) in Response to Mixed Meal (MMTT).|C-peptide measurements collected over a 4 hour period (0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes)after a Mixed Meal Tolerance Test. The area under the curve from these combined measurements is calculated and the unit of measure is nanogram*minutes/ml.|0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes|Participants who completed their 12 month visit were measured.||nanogram*minutes/ml||95% Confidence Interval|Median
133173|NCT00529152|Secondary|Change in Serum Ferritin Concentration From Baseline.|The change in serum ferritin concentration from baseline to week 24 was measured and analyzed for all participants in the study|Baseline and 24 weeks|99 subjects had at least one post baseline measurement of serum ferritin concentration and were eligible for the efficacy analyses in the Intent to Treat population (all subjects). The Last Measurement Carried Forward methodology was used to populate any missing serum ferritin value.||ug/L||Standard Deviation|Mean
133174|NCT00529152|Primary|Occurrence of Adverse Events|Number of Adverse Events over 24 weeks|24 Weeks|All subjects enrolled (100), had at least one dose of Ferriprox oral solution, all were included in safety analysis||Adverse Events|||Number
133175|NCT00529126|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||Up to 30 days||||||
133176|NCT00529126|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?”|0 to 72 hours|||units on a scale*hrs||Standard Deviation|Mean
133177|NCT00529100|Secondary|Phase 2: Site of Progressive Disease (PD)|Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and who had PD.||participants|||Number
133178|NCT00529100|Secondary|Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation) and with measurable disease.||percentage of participants||95% Confidence Interval|Number
133179|NCT00529100|Secondary|Progression Free Survival (PFS)|PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Baseline to measured PD (up to 36 months)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eight participants were censored.||months||95% Confidence Interval|Median
133180|NCT00529100|Secondary|Phase 2: Percentage of Participants With Progression Free Survival (PFS)|The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.|Baseline and 1 year and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).||percentage of participants||95% Confidence Interval|Number
133191|NCT00529087|Secondary|Percentage of Patients With Improvement in Straining Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.||percentage of participants|||Number
133237|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure||percentage of participants|||Number
133181|NCT00529100|Secondary|Phase 2: Time to Progressive Disease (PD)|Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.|Baseline to measured PD (up to 3 years)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation). Eleven participants were censored.||months||95% Confidence Interval|Median
133182|NCT00529100|Secondary|Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years|OS was defined as the time from date of enrollment to death due to any cause.|Baseline and 2 years and 3 years|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).||percentage of participants||95% Confidence Interval|Number
133183|NCT00529100|Secondary|Phase 1: Number of Participants With Adverse Events (AE; Toxicity)|A listing of AEs is located in the Reported Adverse Event module.|Baseline to measured PD (up to 1 year)|The treated population was used for this analysis and included all participants who received at least 1 dose of either study therapy (pemetrexed, cisplatin, or radiation).||participants|||Number
133184|NCT00529100|Primary|Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year|OS was defined as the time from date of enrollment to death due to any cause.|Baseline to date of death from any cause (up to 1 year)|The treated population was considered the primary analysis population for the efficacy endpoints. The efficacy analysis was also completed on the protocol-qualified (PQ)population to assess the sensitivity of the results.||percentage of participants||95% Confidence Interval|Number
133185|NCT00529100|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy|Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.|Baseline to measured progressive disease (PD; up to 1 year)|The treated population included all participants who received at least 1 dose of either study therapy (that is, pemetrexed, cisplatin, or radiation).||milligrams per square meter (mg/m^2)|||Number
133186|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With a Sensation of Complete Evacuation From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
133187|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Straining Scale Scores of 0 or 1 (no, or Mild) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none, 1 = mild and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
133188|NCT00529087|Secondary|Percentage of Patients With Any Diarrhea or Watery Rescue-free Bowel Movements (RFBM) During Open-label Period.|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|weeks 5-12|Patients who continued into the open-label period and received at least 1 dose of test article.||percentage of participants|||Number
133189|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) Classified as Diarrhea or Watery Stools From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass), Type 6 = fluffy pieces with ragged edges, a mushy stool, and Type 7 = watery, no solid pieces (entirely liquid.) This analysis included types 6 and 7.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
133190|NCT00529087|Secondary|Change in Percentage of Rescue-free Bowel Movements (RFBM) With Bristol Stool Form Scale in Type 3 or Type 4 From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1=separate hard lumps like nuts (difficult to pass) and Type 7=watery, no solid pieces (entirely liquid.) Specifically, Type 3=like a sausage but with cracks on the surface, Type 4=Like a sausage or snake, smooth and soft.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage change||Standard Error|Mean
133192|NCT00529087|Secondary|Percentage of Patients With Improvement in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM) by 1 Point During Open Label Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article.||percentage of participants|||Number
133193|NCT00529087|Secondary|Change in Straining Scale Score of Rescue-free Bowel Movements (RFBM) From Baseline During Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The amount of straining associated with bowel movements was assessed using a 5-point straining scale, where 0=none and 4=very severe.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||units on scale||Standard Error|Mean
133194|NCT00529087|Secondary|Change in Bristol Stool Form Scale Score for Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The Bristol Stool Form Scale assessed stool quality using a 7-point scale, where Type 1 = separate hard lumps like nuts (difficult to pass) and Type 7 = watery, no solid pieces (entirely liquid.)|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||units on scale||Standard Error|Mean
133195|NCT00529087|Secondary|Change in Weekly Number of Complete Rescue-free Bowel Movements (RFBM)|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). Weekly number of complete RFBM was the total number of complete RFBM reported in study period divided by the number of days with information, and multiplied by 7 for a normalized weekly number. A complete RFBM has a sensation of complete evacuation.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||bowel movements||Standard Error|Mean
133196|NCT00529087|Secondary|Change From Baseline in Weekly Number of Quality Rescue-free Bowel Movements (RFBM)|RFBM defined as bowel movement with no laxatives during the prior 24 hours. Information on laxative use, bowel movements and assessments were reported daily by patient. Weekly number of quality RFBM was the total number of quality RFBM reported in study period divided by number of days with information and multiplied by 7 for a normalized weekly number. Stool quality assessed with the Bristol Stool Form Scale (7-points) (1=difficult to pass, 7=entirely liquid). A quality RFBM defined as one other than diarrhea (Bristol Type 1–5).|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||bowel movements||Standard Error|Mean
133197|NCT00529087|Secondary|Change in Weekly Number of Bowel Movements During Double-blind Period|Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). The weekly number of BM was defined as the total number of BMs reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||bowel movements||Standard Error|Mean
133198|NCT00529087|Secondary|Percentage of Patients With an Increase of at Least 1 in the Weekly Rescue-free Bowel Movement (RFBM) Rate From Baseline for the Double-blind Period at 4 Weeks|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage of participants|||Number
133199|NCT00529087|Secondary|Percentage of Patients With a Weekly Rescue-free Bowel Movement (RFBM) Rate ≥ 3 and an Increase of at Least 1 in the Weekly RFBM Rate From Baseline for the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly RFBM rate was defined as the total number of RFBM reported during study period divided by the number of days the subject reported diary information in that period, and then multiplied by 7 to normalize to a weekly rate.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF)||percentage of participants|||Number
133200|NCT00529087|Secondary|Percentage of Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3, 4 and 6 Hours in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|Within 1-6 hours during 4-week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).||percentage of injections||Standard Deviation|Mean
133235|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks|This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
133238|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks||336 weeks||||||
133239|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks||288 weeks||||||
133201|NCT00529087|Secondary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|Within 1-6 hours during 4 week double-blind period|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).||percentage of active injections||Standard Deviation|Mean
133202|NCT00529087|Secondary|Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBM reported during the study week divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.||percentage of participants|||Number
133203|NCT00529087|Secondary|Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone IVRS. The weekly number of RFBM was defined as the total number of RFBMs reported during study period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number. Weekly number of RFBM determined as missing for <4 days of information.|8 weeks|Patients who continued into the open-label period and received at least 1 dose of test article. Observed case analysis.||bowel movements||Standard Deviation|Mean
133204|NCT00529087|Secondary|Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks|A rescue-free bowel movement defined as a bowel movement with no laxatives use during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were reported daily by patient using a telephone interactive voice response system (IVRS). The weekly number of RFBM was defined as the total number of RFBM reported during the double-blind period divided by the number of days the patient reported diary information in that period, and then multiplied by 7 to normalize to a weekly number.|Baseline and 4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article. Last observation carried forward (LOCF).||bowel movements||Standard Error|Mean
133205|NCT00529087|Secondary|Time to the First Rescue-free Bowel Movement (RFBM) After First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Responses following first injection were censored at 24 hours or at time of the second injection, which ever occurred first.|up to 24 hours|Patients who were randomized and received at least 1 dose of double-blinded test article.||% of subjects achieving RFBM in 24 hours|||Number
133206|NCT00529087|Primary|Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.|4 weeks|Patients who were randomized and received at least 1 dose of double-blinded test article.||percentage of active injections||Standard Deviation|Mean
133207|NCT00529087|Primary|Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose|A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).|up to 4 hours|Patients who were randomized and received at least 1 dose of double-blinded test article. For this analysis, the MOA-728 QD and MOA-728 QOD treatment groups were combined as the treatment regimen was the same through the first dose (day 1).||percentage of participants|||Number
133208|NCT00529035|Secondary|Treg Cell:Tcon Cell Ratio|"Changes in the ratio of the CD4+ regulatory T cell (Treg) and CD4+ conventional T cell (Tcon) counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.~All study participants (n=28) with a sample available were reported in the data table.~Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for changes to the ratio of regulatory T cell (Treg) and conventional T cell (Tcon) counts while on IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule to analyze the immunological effects of low-dose IL-2 therapy.||ratio||Inter-Quartile Range|Median
133209|NCT00529035|Secondary|CD3+T, CD4+T (Including Regulatory CD4+T Cells (Treg) and Conventional CD4+T Cells (Tcon)), CD8+T, NK, NKT and B Cell Counts.|"Changes in the above immune cell populations (CD3+T, CD4+T (including CD4+Treg and CD4+Tcon), CD8+T, NK, NKT and B cell counts were measured at study appointments during the 8-week IL-2 treatment and four weeks post study therapy.~All study participants (n=28) with a sample available were reported in the data table.~Immune outcome data cannot be meaningfully rendered in the template provided, owing to complexity. The tables below only represent a general overview of the data. Please refer to figure 2 in our published report (Koreth et al, NEJM 2011)."|Immunological samples taken at study appointments during the 12 week protocol schedule|Participants were evaluated for regulatory T cell (Treg) expansion and other immune-cell changes while on low-dose IL-2 therapy. Participants had blood samples drawn at study appointments during the 12 week protocol schedule. Please note that for NK and NKT cell counts, only 18 participants samples were analyzed.||cells/cubic millimeter||Inter-Quartile Range|Median
133210|NCT00529035|Secondary|The Number of Participants Who Tolerated at Least 6 Weeks of Subcutaneous Low Dose IL-2.|"Feasibility: the number of participants who tolerated at least 6 weeks of therapy, and were thus evaluable for response. Efficacy: chronic GVHD response per NIH consensus criteria in evaluable patients.~A complete response was defined as resolution of all reversible chronic GVHD–associated manifestations, a partial response as an improvement of 50% or more on the organ-specific chronic GVHD scale without progression at other organs or sites, progressive disease as an increase of 25% or more on the organ specific chronic GVHD scale, and stable disease as an improvement of less than 50% or increase of less than 25%. Please refer to the Supplementary Appendix in our published report (Koreth et al, NEJM 2011) for further details."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy. cGVHD was assessed at Weeks 8 and 12|Participants were evaluable for response and considered meeting the feasibility endpoint if they completed at least 6 weeks of treatment. Participants who had a partial response or complete response in cGVHD to treatment were considered to meet the efficacy endpoint.||participants|||Number
133211|NCT00529035|Primary|The Maximum Tolerated Dose and Toxicity Profile of an 8 Week Course of IL-2 in Patients With cGVHD and an Inadequate Response to Steroids.|"Three dose levels were evaluated to determine the maximally tolerated dose (MTD):~Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/m^2/day Once the MTD (dose level B) was established, an additional 10 participants were enrolled at this dose."|Participants were assessed for toxicities at mandatory study follow-up visits during the 8 week course of study therapy and four weeks post therapy|One participant terminated therapy early and was not evaluable for this outcome measure.||million IU/m2/day|||Number
133212|NCT00527124|Secondary|Overall Survival|Analyzed with standard K-M methodology.|The time from registration date until death from any cause, assessed up to 52 weeks||||||
133213|NCT00527124|Secondary|Time to Progression|Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm.|The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks||||||
133214|NCT00527124|Secondary|Partial and Complete Response Rate Evaluated by the RECIST Criteria|Will be analyzed with standard Kaplan-Meier (K-M) methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of each of these two TTE endpoints.|Up to 52 weeks||||||
133215|NCT00527124|Secondary|Prostate-specific Antigen (PSA) Response and PSA Control Duration in Accordance With the Prostate Specific Antigen Working Group|Will be analyzed with standard Kaplan-Meier (K-M) methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of each of these two TTE endpoints.|Up to 52 weeks||||||
133216|NCT00527124|Primary|6-month Progression-free Survival (PFS) Proportion|The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free|Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months|Per protocol. 30 subjects on Arm I and 28 subjects on Arm II accrued for analysis of the primary endpoint of 6 mths PFS proportion. PFS is obtainable on all 58 participants enrolled, however 1 subject enrolled on Arm I withdrew before receiving any treatment, hence cannot be included for AE analysis and reporting, AE results involve 29 subjects.||percentage of patients||95% Confidence Interval|Number
133217|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks||Baseline and 336 weeks||||||
133218|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks||Baseline and 288 weeks||||||
133219|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks||Baseline and 240 weeks||||||
133220|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks||Baseline and 192 weeks||||||
133221|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks|This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded||cells/mm^3||Standard Deviation|Mean
133222|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks|This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded||cells/mm^3||Standard Deviation|Mean
133223|NCT00528957|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks|This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded||cells/mm^3||Standard Deviation|Mean
133224|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 336 Weeks||Baseline and 336 weeks||||||
133225|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 288 Weeks||Baseline and 288 weeks||||||
133226|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 240 Weeks||Baseline and 240 weeks||||||
133227|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 192 Weeks||Baseline and 192 weeks||||||
133228|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 144 Weeks|This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF.|Baseline and 144 weeks|Intent-to-treat, Missing = Excluded||CD4 Percentage||Standard Deviation|Mean
133229|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 96 Weeks|This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF.|Baseline and 96 weeks|Intent-to-treat, Missing = Excluded||CD4 Percentage||Standard Deviation|Mean
133230|NCT00528957|Secondary|Change From Baseline in CD4 Percentage at 48 Weeks|This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug.|Baseline and 48 weeks|Intent-to-treat, Missing = Excluded||CD4 Percentage||Standard Deviation|Mean
133231|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks||336 weeks||||||
133232|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks||288 weeks||||||
133233|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks||240 weeks||||||
133234|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks||192 weeks||||||
133242|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF.|144 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
133243|NCT00528957|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF.|96 weeks|Intent-to-treat, Missing = Failure. Participants who had not reached the upper limit of the analysis window (date varies depending on analysis time frame) were excluded.||percentage of participants|||Number
133244|NCT00528957|Secondary|Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)|This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug.|48 weeks|ITT Analysis Set; only includes participants < 12 years of age at baseline||percentage of participants|||Number
133245|NCT00528957|Primary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug.|48 weeks|Intent-to-treat, Missing = Failure||percentage of participants|||Number
133246|NCT00528931|Secondary|Change From Baseline Range of Motion|Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.||Degrees|Participants|Standard Deviation|Mean
133247|NCT00528931|Secondary|Percent Reduction From Baseline Contracture|Reduction from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture) divided by baseline contracture.|Baseline, 30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.||Percentage of contracture change|Participants|Standard Deviation|Mean
133248|NCT00528931|Secondary|Clinical Improvement|Clinical improvement defined as ≥50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection.||Percentage of joints|Participants||Number
133249|NCT00528931|Secondary|Clinical Success|Clinical success defined as a reduction in contracture (ie, flexion deformity) to ≤5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined.|30 days after treatment to the primary joint|Efficacy assessment based on safety population which included all enrolled subjects who received the AA4500 injection||Percentage of joints|Participants||Number
133250|NCT00528931|Primary|Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500|AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA).|Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30|Pharmacokinetic population||participants|||Number
133251|NCT00528879|Secondary|Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and who had HbA1c values at Baseline and Week 24 (LOCF)||Percentage of participants|||Number
133252|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 1|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 1 (LOCF)||mg/dL||Standard Error|Mean
133253|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had a BMI ≥27 kg/m^2 at baseline, and who had nonmissing HbA1c values at Week 24 (LOCF)||Percent||Standard Error|Mean
133254|NCT00528879|Other Pre-specified|Number of Participants With Orthostatic Hypotension|Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.|From Baseline to Week 102|All randomized participants who received treatment; n=the number of participants who were not missing blood pressure measurements.||Participants|||Number
133285|NCT00528645|Secondary|Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|6 months||||||
133286|NCT00528645|Secondary|Survival Time|Will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 2 years||||||
133255|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Diastolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.||mm Hg||Standard Error|Mean
133256|NCT00528879|Other Pre-specified|Mean Changes From Baseline in Seated Systolic Blood Pressure|Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 102|All randomized participants who received study medication. n=the number of participants not missing baseline and Week t values.||mm Hg||Standard Error|Mean
133257|NCT00528879|Other Pre-specified|Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])|12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.|Baseline to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing baseline and Week 102 (LOCF) values||Participants|||Number
133258|NCT00528879|Other Pre-specified|Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality|BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.|Day 1 to Week 102|All randomized participants who received at least 1 dose of study medication and who had nonmissing laboratory values at baseline and Week 102.||Participants|||Number
133259|NCT00528879|Other Pre-specified|Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.|From Baseline to end of Long-term Period (Week 102)|All randomized participants who received at least 1 dose of blinded study medication||Participants|||Number
133260|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline BMI ≥27 kg/m^2, and who had nonmissing total body weight measurements at Week 24 (LOCF)||Kilograms||Standard Error|Mean
133261|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication, who had baseline HbA1c ≥9.0%, and who had nonmissing HbA1c values at Week 24 (LOCF)||Percent||Standard Error|Mean
133262|NCT00528879|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values||Percentage of participants|||Number
133859|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 64 weeks|||seconds||95% Confidence Interval|Least Squares Mean
133263|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing total body weights at baseline and Week 24 (LOCF)||Kilograms||Standard Error|Mean
133264|NCT00528879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24|All randomized participants who received study medication and who had nonmissing fasting plasma glucose values at baseline and Week 24 (LOCF)||mg/dL||Standard Error|Mean
133265|NCT00528879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)||Percent||Standard Error|Mean
133266|NCT00528840|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment||||||
133267|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment||||||
133268|NCT00528840|Secondary|Clinical Improvement After the First Injection||30 days after first treatment||||||
133269|NCT00528840|Secondary|Clinical Success After the First Injection||30 days after first treatment||||||
133270|NCT00528840|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation||||||
133271|NCT00528840|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment||||||
133272|NCT00528840|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment||||||
133273|NCT00528840|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment||||||
133274|NCT00528840|Primary|Reduction in Contracture to 5° or Less|"The Primary Outcome Measure is the percentage of 292 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|All Joints Treated With AA4500 0.58 mg||% Joints|||Number
133275|NCT00528801|Secondary|Volume of Total Cortical Gray Matter as Measured by Volumetric MRI.|The cortical gray matter is the gray matter of the cerebral cortex only and does not include subcortical gray matter such as hippocampus or basal ganglia.|Within 2 months of informed consent|Per protocol, no imputations.||mL||Standard Deviation|Mean
133276|NCT00528801|Secondary|Participants With Brain Lacunae as Measured by Clinical MRI|Particpants with imaging abnormalities as measured by MRI (Magnetic Resonance Imaging) specifically brain lacunae. Lacunar infarcts are 3-15 mm in diameter located at the basal ganglia, capsular and thalamic regions. Lesions located at the level of the anterior commisure are considered perivascular spaces unless >5 mm in diameter.|Within 2 months of informed consent|Per protocol, no imputation.||Participants|||Number
133277|NCT00528801|Primary|Wechsler Adult Intelligence Scale (WAIS)-III Performance IQ|Extent of neurocognitive dysfunction in neurologically asymptomatic adult patients with sickle cell disease as measured by WAIS-III performance IQ. This quotient is based on an average of 100, with a standard deviation of 15. The Wechsler intelligence scales are not considered adequate measures of extremely high and low intelligence (IQ scores above 160 and below 40, respectively). The performance IQ is derived from scores on seven subtests: picture completion, picture arrangement, block design, object assembly, digit symbol, matrix reasoning, and symbol search.|Within 2 months of signing informed consent.|Per protocol, no imputation used.||Points on a scale||Standard Deviation|Mean
133278|NCT00528788|Primary|Change in Endothelial Cell Function|Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.|1 month|prospective open-label 30-day observational study testing the effects of doxercalciferol on mediated vasodilation (FMD) among 20 dialysis pts with secondary hyperparathyroidism||percent change in FMD||Standard Deviation|Mean
133279|NCT00528775|Secondary|Inflammation and Apoptosis as Assessed by Immunohistochemistry||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133280|NCT00528775|Secondary|STAT3 Cross-links as Assessed by Western Blotting||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133281|NCT00528775|Secondary|Photosensitizer (HPPH) Concentration in Tumor||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133282|NCT00528775|Secondary|Palliation of Symptoms as Assessed by the Pulmonary Symptom Scale||2 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133287|NCT00528645|Primary|Progression-free Survival Rate at 12 Weeks|The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.|12 weeks|||percentage of participants||95% Confidence Interval|Number
133288|NCT00528606|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint||||||
133289|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint||||||
133290|NCT00528606|Secondary|Clinical Improvement After the First Injection||30 days after first treatment to the primary joint||||||
133291|NCT00528606|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint||||||
133292|NCT00528606|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint||||||
133293|NCT00528606|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint||||||
133294|NCT00528606|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint||||||
133295|NCT00528606|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment to the primary joint||||||
133296|NCT00528606|Primary|Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 203 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.~The Primary Outcome Measure for placebo treated patients is the percentage of 103 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|Modified-Intent-to-Treat population||% Joints|||Number
133297|NCT00528567|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|Through end of study: 30 June 2014: up to 77 months|Safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all other patients were analyzed in the chemotherapy arm.||Participants|||Number
133298|NCT00528567|Secondary|Percentage of Participants With Distant Disease-Free Survival (DDFS) Events|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
133299|NCT00528567|Secondary|Time to Distant Disease-Free Survival (DDFS) Event|DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
133300|NCT00528567|Secondary|Percentage of Participants With Disease-Free Survival (DFS) Events|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
133301|NCT00528567|Secondary|Time to Disease-Free Survival (DFS) Event|DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
133302|NCT00528567|Secondary|Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
133860|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 48 weeks|||seconds||95% Confidence Interval|Least Squares Mean
133303|NCT00528567|Secondary|Time to Breast Cancer-Free Interval (BCFI) Event|BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat participants, defined as all randomized participants.||Months||95% Confidence Interval|Median
133304|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.||percentage of participants|||Number
133305|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
133306|NCT00528567|Secondary|Percentage of Participants With Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cut off: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||percentage of participants|||Number
133307|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
133308|NCT00528567|Primary|Percentage of Participants With Invasive Disease-free Survival (IDFS) Events|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.|Event driven (until data cutoff: 29 February 2012 up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Percentage of participants|||Number
133309|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 30 June 2014: up to 77 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
133310|NCT00528567|Secondary|Time to Overall Survival (OS) Event|OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
133311|NCT00528567|Primary|Time to Invasive Disease-free Survival (IDFS) Event|IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.|Event driven (until data cutoff: 29 February 2012: up to 49 months)|Intent-to-treat population, defined as all randomized participants.||Months||95% Confidence Interval|Median
133312|NCT00528541|Secondary|Patient Comparison of Benefit to Previous Injections at Week 10|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this timepoint are included.||Number of Responses|||Number
133313|NCT00528541|Secondary|Physician Comparison of Benefit to Previous Injections at Week 10|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 10|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at this time point are included.||Number of Responses|||Number
133314|NCT00528541|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
133315|NCT00528541|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection' and 'does not require injection'."|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1. Only completed assessments at the time points are included.||Number of Responses|||Number
133316|NCT00528541|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
133317|NCT00528541|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater).'|Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
133318|NCT00528541|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever.'|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Units on a Scale||Full Range|Median
133319|NCT00528541|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS assessments were conducted at each study visit. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. It is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Scores on a Scale||Full Range|Median
133320|NCT00528541|Primary|Dysphagia Incidence Over 10 Weeks|Dysphagia Incidence (difficulty swallowing) was defined as the number of patients reporting at least 1 treatment-emergent dysphagia event at any point in the study. Occurrences of dysphagia were captured as spontaneous events or were assessed during study visits using the Structured Symptom Interview (SSI) and the Dystonia Study Group Dysphagia Interview (DSGDI) for symptoms of difficulty swallowing; coughing while eating and drinking; choking while eating or drinking; or difficulty swallowing solids or liquids.|10 weeks|Modified intent to treat: all patients who were randomized to treatment and received 1 dose at Visit 1.||Number of patients|||Number
133321|NCT00528528|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)|SVR24 was defined as having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples) at EOT and no confirmed detectable HCV RNA levels between EOT and 24 weeks after the last dose of study medication.|EOT (up to Week 48) and up to 24 weeks after EOT|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
133322|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology.|Baseline (pre-dose), EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||log 10 IU/mL||Standard Error|Mean
133323|NCT00528528|Secondary|Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12|Change from baseline in log 10 of Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test (lower limit of quantification 25 IU/mL). The assay used real-time reverse transcription - polymerase chain reaction (RT-PCR) methodology. HCV RNA samples were taken pre-dose of Peg-IFN administration.|Baseline (pre-dose), Week 12|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||log 10 IU/mL||Standard Error|Mean
133324|NCT00528528|Secondary|Percentage of Participants With Partial Response|Partial response was defined as having at least 2 log drop in HCV RNA from Baseline, but not having undetectable HCV RNA (i.e., no HCV RNA is detected in the participants’ plasma samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
133325|NCT00528528|Secondary|Number of Participants With Viral Breakthrough at End of Treatment (EOT)|Viral breakthrough was defined as a confirmed increase of more than 1 log 10 in HCV RNA level from the lowest level reached or a confirmed value of HCV RNA more than 100 IU/mL in participants whose HCV RNA was previously less than 25 IU/mL.|EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Participants|||Number
133349|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Breaths/minute||Standard Deviation|Mean
133326|NCT00528528|Secondary|Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|Virologic response was either defined as having undetectable HCV RNA (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 IU/mL HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|Baseline (Day 1) up to EOT (up to Week 48)|FAS population included all randomly assigned participants who received at least 1 dose of the study medication.||Days||Full Range|Median
133327|NCT00528528|Primary|Percentage of Participants With Virologic Response at Week 12|Virologic response was either defined as having undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) (i.e., no HCV RNA was detected in the participants’ plasma samples) or less than 25 international units/milliliter (IU/mL) HCV RNA (i.e., the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples).|End of treatment (EOT) (up to Week 48)|Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of the study medication.||Percentage of participants|||Number
133328|NCT00528450|Primary|Molecular Remission Rate|# of patients with Complete Remission|2 years|||participants|||Number
133329|NCT00528424|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment||||||
133330|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment||||||
133331|NCT00528424|Secondary|Clinical Improvement After the First Injection||30 days after first treatment||||||
133332|NCT00528424|Secondary|Clinical Success After the First Injection||30 days after first treatment||||||
133333|NCT00528424|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation||||||
133334|NCT00528424|Secondary|Change From Baseline Range of Motion After the Last Injection||30 days after last treatment||||||
133335|NCT00528424|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment||||||
133336|NCT00528424|Secondary|Clinical Improvement After the Last Injection||30 days after last treatment||||||
133337|NCT00528424|Primary|Reduction in Contracture to 5° or Less|"The Primary Outcome Measure is the percentage of 320 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|Within 30 days after the last injection|||% joints|||Number
133338|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: SpO2|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Percentage||Standard Deviation|Mean
133339|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)|SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Percent||Standard Deviation|Mean
133340|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP|NT-proBNP is measured by clinical lab, the unit is pg/mL.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||pg/ml||Standard Deviation|Mean
133341|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|NT-proBNP is measured by clinical lab, the unit is pg/mL.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||pg/ml||Standard Deviation|Mean
133342|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: EF|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Percent||Standard Deviation|Mean
133343|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)|EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Percent||Standard Deviation|Mean
133344|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Percent||Standard Deviation|Mean
133345|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)|DLCOSB is measured by Body Box Plethysmography, the unit is Percent.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Percent||Standard Deviation|Mean
133346|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VT|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liters/minute||Standard Deviation|Mean
133347|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)|VT is measured by Body Box Plethysmography, the unit is Liter/Minute.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liters/minute||Standard Deviation|Mean
133348|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RR|RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Breaths/minute||Standard Deviation|Mean
133350|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: VE|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter/minute||Standard Deviation|Mean
133351|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)|VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter/minute||Standard Deviation|Mean
133352|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: RV|RV is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
133353|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Residual Volume (RV)|RV is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
133354|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: TLC|TLC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
133355|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)|TLC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
133356|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FRC|FRC is measured by Body Box Plethysmography, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
133357|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)|FRC is measured by Body Box Plethysmography, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
133358|NCT00528411|Secondary|Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter/second||Standard Deviation|Mean
133359|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)|FEF25-75 is measured by Spirometry, the unit is Liter/Second.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter/second||Standard Deviation|Mean
133360|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Ratio||Standard Deviation|Mean
133361|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)|FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Ratio||Standard Deviation|Mean
133362|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FVC|FVC is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
133363|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)|FVC is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
133364|NCT00528411|Secondary|Cardiopulmonary Parameters at Post 6-week Treatment: FEV1|FEV1 is measured by Spirometry, the unit is Liter.|6-week post treatment|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.||Liter||Standard Deviation|Mean
133365|NCT00528411|Secondary|Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is measured by Spirometry, the unit is Liter.|Baseline|Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.||Liter||Standard Deviation|Mean
133366|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|240 hours - Day 10 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133367|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|168 hours - Day 7 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133433|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 3|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 3|A subset of women from the full analysis set||Participants|||Number
133368|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|120 hours - Day 5 after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133369|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|72 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133370|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|48 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133371|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133372|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133373|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133374|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|2 hours after last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133375|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0 hour before last dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133376|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|24 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133377|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|8 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133861|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 32 weeks|||seconds||95% Confidence Interval|Least Squares Mean
133378|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|4 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133379|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|1 hour after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133380|NCT00528411|Secondary|Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|0.5 hours after first dose|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133381|NCT00528411|Primary|Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.|4 to 72 Hours after last dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage/Hour||Standard Error|Least Squares Mean
133382|NCT00528411|Primary|Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose|IPA(%)=(PAb-PAt)/PAb*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.|At 2 hours after first dose of study drug|Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.||Percentage||Inter-Quartile Range|Median
133383|NCT00528398|Secondary|Bone Marrow at Day 7 Post-Induction Chemotherapy|Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)|7 days post completion of induction chemotherapy|||Participants|||Count of Participants
133384|NCT00528398|Primary|Complete Remission (CR)|The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.|7 days post completion of induction chemotherapy|||Participants|||Count of Participants
133385|NCT00528372|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])|12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who received at least 1 dose of study medication and who had measurements available||Participants|||Number
133386|NCT00528372|Secondary|Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)|Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Day 1 to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available||Participants|||Number
133387|NCT00528372|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)|Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66.|Baseline to Week 102 (end of Long-term Period)|Randomized participants who received at least 1 dose of study medication and with laboratory test results available||Participants|||Number
133434|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 2|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 2|A subset of women from the full analysis set||Participants|||Number
135020|NCT00517075|Secondary|Cortical Excitability||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
133388|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values||Percent||Standard Deviation|Mean
133389|NCT00528372|Secondary|Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.|Day 1 to Week 102 (end of Long-term Period) + 30 days|Randomized participants who received at least 1 dose of study medication||Participants|||Number
133390|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 values||Kilograms||Standard Error|Mean
133391|NCT00528372|Secondary|Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c values at both baseline and Week 24 (LOCF)||Percentage of participants|||Number
133392|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with baseline BMI ≥27 kg/m^2 and nonmissing baseline and Week 24 LOCF values||Percent||Standard Error|Mean
133393|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c >9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week24 LOCF values.||Percent||Standard Error|Mean
133435|NCT00528112|Secondary|Number of Participants With/Without Ovulation – Year 1|Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.|For six weeks in the second half of Year 1|A subset of women from the full analysis set||Participants|||Number
133394|NCT00528372|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.|Baseline to Week 24 (end of Short-term Period)|Randomized participants who had nonmissing baseline and Week 24 LOCF values||Percentage of participants|||Number
133395|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment with nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Deviation|Mean
133396|NCT00528372|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline to Week 1 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Error|Mean
133397|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment nonmissing baseline and Week 24 LOCF values.||Kilograms||Standard Deviation|Mean
133398|NCT00528372|Secondary|Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|From Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 values||Kilograms||Standard Error|Mean
133399|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2|Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Deviation|Mean
133413|NCT00526994|Primary|Quality of Life, Mental Health Composite|Assessed with the Quality of Life SF-12 v.2 (Ware, Kosinski, Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|past 30 days|||units on a scale||95% Confidence Interval|Mean
133414|NCT00526994|Secondary|Disability|days lost from housework|one year follow-up|||days||95% Confidence Interval|Mean
133415|NCT00526994|Secondary|Utilization of Health Care|number of ambulatory care visits|during past year|||visits||95% Confidence Interval|Mean
133400|NCT00528372|Secondary|Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1|Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values||mg/dL||Standard Error|Mean
133401|NCT00528372|Primary|Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1|HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.|Baseline to Week 24 (end of Short-term Period)|Randomized participants with nonmissing baseline and Week 24 LOCF values||Percent||Standard Error|Mean
133402|NCT00528268|Secondary|The Study Will Determine Potential Benefit of NaPB on Lean Body Mass; Overall Motor Function; Potential Cellular Response to NaPB; and Drug Compliance.||24 months||||||
133403|NCT00528268|Primary|The Study Will Assess the Safety, Tolerability and Potential Efficacy of Sodium Phenylbutyrate (NaPB) in Presymptomatic Infants Genetically Confirmed to Have SMA. It Will Also Determine Selected Pharmacokinetic Parameters.|Number of participants with SAE's related to research.|24 months|||participants|||Number
133404|NCT00527111|Secondary|KRAS Mutation Rate|Percentage of Participants with KRAS mutation.|5 years|ITT population with KRAS test||percentage of participants with mutation|||Number
133405|NCT00527111|Secondary|Recurrence-free Survival (RFS) Rate at 5 Years|RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact.|5 years|ITT population||probability of recurrence-free survival||95% Confidence Interval|Number
133406|NCT00527111|Secondary|5- Year Overall Survival (OS) Rate|Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact.|5 years|ITT population||probability of overall survival||95% Confidence Interval|Number
133407|NCT00527111|Secondary|To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|5 years|Evaluable Population||percentage of participants||95% Confidence Interval|Number
133408|NCT00527111|Primary|Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.|A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes.|5 years|Post surgery population||percentage of participants||95% Confidence Interval|Number
133409|NCT00527098|Primary|Mortality||From hospital arrival up to an average of 3.5 weeks|Analysis was per protocol.||participants|||Number
133410|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26||Week 26|This analysis is based on all observed mITT patients. The treatment failures will be classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, their data at that visit will not be imputed.||participants|||Number
133411|NCT00527072|Secondary|Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10|A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.|Week 10|Analysis is based on observed mITT (modified Intent to Treat) patients. Treatment failures are classified as not achieving a PASI 50, 75, 90, or 100 response at all visits after the date of treatment failure. For non-treatment failure patients who did not have a PASI score at the visit due to other reasons, will not have data imputed at that visit.||participants|||Number
133412|NCT00527072|Primary|Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0)|Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).|Week 10|This analysis is based on the evaluable population that includes the all enrolled patients who received at least one infliximab infusion, and had a baseline PGA score greater than 1.||participants|||Number
133432|NCT00528112|Secondary|Average Total Cervical Score – Year 1|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 1|A subset of women from the full analysis set||Scores on a scale||Standard Deviation|Mean
133782|NCT00525824|Secondary|Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment|Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133416|NCT00526994|Primary|Quality of Life, Physical Health Composite|Assessed with Quality of Life SF-12 V.2 (Ware, Kosinski,Turner-Bowker, & Gandek, 2002). This instrument has 12 items measuring eight subscales of mental and physical health—general health, physical functioning, role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, vitality (energy/fatigue), social functioning, and mental health (psychological distress)—during the past 4 weeks. These subscales are combined to form a physical health composite scale and a mental health composite scale. Each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state.|at one-year follow-up|||units on a scale||95% Confidence Interval|Mean
133417|NCT00525915|Primary|Pathologic Complete Response Rate|Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.|Surgery post chemotherapy (approximately 10-11 weeks)|Participants who had surgery were reported for the pathCR rate assessment in this outcome.||percentage of participants|||Number
133418|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|50 Weeks|Participants characterized as clinical responders at 10 weeks were allowed to continue in the study.||participants|||Number
133419|NCT00525902|Primary|Cumulative Endpoint|Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.|10 weeks|||participants|||Number
133420|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion up to 5 Years|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 5 years|All participants from the full analysis set who had an assessment for this evaluation||Participants|||Number
133421|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment up to 5 Years|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 5|All participants from the full analysis set who participated in the extension phase and had an assessment for this evaluation||Participants|||Number
133422|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1711 to Day 1800|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133423|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1081 to Day 1170|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133424|NCT00528112|Primary|Pearl Index for LCS16 up to 5 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.|Up to 5 years|Full analysis set||Pregnancies per 100 women years||95% Confidence Interval|Number
133425|NCT00528112|Secondary|Number of Participants With Partial or Total Expulsion|If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.|Up to 3 years|All participants from the full analysis set who had an assessment for this evaluation||Participants|||Number
133426|NCT00528112|Secondary|Degree of User Overall Satisfaction With Study Treatment|Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.|At the end of study/Year 3|All participants from the full analysis set who had an assessment for this evaluation||Participants|||Number
133427|NCT00528112|Secondary|Classification of Endometrium – Year 3 / End of Study|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 3 / End of study|A subset of women from the full analysis set||Participants|||Number
133428|NCT00528112|Secondary|Classification of Endometrium – Year 2|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 2|A subset of women from the full analysis set||Participants|||Number
133429|NCT00528112|Secondary|Classification of Endometrium – Year 1|The histological evaluation of the endometrium examined the effects of progesterone on the endometrium|At Year 1|A subset of women from the full analysis set||Participants|||Number
133430|NCT00528112|Secondary|Average Total Cervical Score – Year 3|Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)|For six weeks in the second half of Year 3|A subset of women from the full analysis set||Scores on a scale||Standard Deviation|Mean
133431|NCT00528112|Secondary|Average Total Cervical Score – Year 2|"Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.~Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)"|For six weeks in the second half of Year 2|A subset of women from the full analysis set||Scores on a scale||Standard Deviation|Mean
133436|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 331 to Day 360|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133437|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 120|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133438|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 61 to Day 90|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133439|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 31 to Day 60|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133440|NCT00528112|Secondary|Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 30|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133441|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 991 to Day 1080|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133442|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 271 to Day 360|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133443|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 181 to Day 270|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133444|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 91 to Day 180|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133445|NCT00528112|Secondary|Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1|The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.|Day 1 to Day 90|All participants from the full analysis set who had an assessment for this evaluation||Days||Standard Deviation|Mean
133446|NCT00528112|Primary|Pearl Index up to 3 Years|The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.|Up to 3 years|Full analysis set||Pregnancies per 100 women years||95% Confidence Interval|Number
133447|NCT00528021|Primary|Clinical Cure|No live lice 14 days following last treatment|Day 15 or 22|||participant|||Number
133448|NCT00527982|Primary|Histological Responses|Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.|Baseline to 12 months|No analysis. One registered patient inevaluable for response, study terminated early.|||||
133449|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 2 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133450|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 2 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133451|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133452|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced RIR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of RIR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced RIR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm||Percentage of Participants|||Number
133453|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133454|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 2 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133455|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause Death, MI, stroke, or UCR I within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133456|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced All-cause Death, MI, Stroke, RIR, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: all-cause death, MI, stroke, RIR, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced all-cause death, MI, stroke, RIR, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133457|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or MI Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133458|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
139118|NCT00476788|Primary|A1c|Measure of glycemic control over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.|6.9 months (average)|||percentage of glycated hemoglobin||Standard Deviation|Mean
133459|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 2 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 2 years from randomization.|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
133460|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 2 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 2 years from randomization.|Up to 2 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
133461|NCT00527943|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, and/or Stroke Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), and/or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the secondary composite efficacy endpoint within 2 years from randomization.|up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133462|NCT00527943|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular Death, Myocardial Infarction, Stroke, Recurrent Ischemia With Re-hospitalization, and/or Urgent Coronary Revascularization Within 2 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular (CV) death, myocardial infarction (MI), stroke, recurrent ischemia with re-hospitalization (RIR), and/or urgent coronary revascularization (UCR). A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced at least 1 of the components of the primary composite efficacy endpoint within 2 years from randomization.|Up to 2 years|Intent to Treat Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133463|NCT00527904|Primary|Number of Subjects Monitored for Long-term Safety of PN 400|Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window.|12 months|Approximately 200 subjects were planned, 239 were enrolled and treated and 143 subjects completed the study. All 239 subjects were evaluable for safety.||participants|||Number
133464|NCT00527878|Secondary|Clinical Severity Score|Scoring that was completed every 3 months. Clinical severity scored had outcomes that could range from 0 to 121 with 0 being the least severe and 121 being the most severe.|one year on ranitidine and one year on placebo|Patients who completed the study||score on a scale||Full Range|Mean
133465|NCT00527878|Secondary|New Lung Infections|Number of new infection while on placebo or study drug|12 months placebo and 12 months ranitidine|Patients who completed the study||new lung infections||Full Range|Median
133466|NCT00527878|Secondary|New Skin Infections|Patients reported the number of new skin infections|12 months placebo/12 months ranitidine|Patients that completed the study||skin infections||Full Range|Median
133467|NCT00527878|Primary|Number of Infections in Subjects With HIES.|Patients received one year of treatment medication and one year of placebo. New infections (bacterial, fungal, viral or parasitic) were defined as those requiring an addition or change of an antimicrobial (including topical, oral or intravenous therapies) or those requiring a medical procedure (i.e., incision and drainage of a skin abscess, warm soaks to aid abscess drainage or sinus drainage).|1 year on intervention|Patients that completed both arms of the study (24 months)||infections||Full Range|Median
133468|NCT00527826|Secondary|Mean Total Costs (Related to COPD) Per Participant|"Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used as required were assumed to be used every second day."|Baseline through Week 52|ITT Population||Euros per participant||Standard Deviation|Mean
133543|NCT00527514|Primary|Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring||Baseline to 12 Weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.||mm Hg||Standard Deviation|Mean
133469|NCT00527826|Secondary|Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
133470|NCT00527826|Secondary|Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
133471|NCT00527826|Secondary|Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
133472|NCT00527826|Secondary|Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52|Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.|Baseline and Week 52|ITT Population||percent||Standard Deviation|Mean
133473|NCT00527826|Secondary|Mean Change From Baseline in the Tiffeaneau Index at Week 52|The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.|Baseline and Week 52|ITT Population||percent of IVC||Standard Deviation|Mean
133474|NCT00527826|Secondary|Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52|Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.|Baseline and Week 52|ITT Population||liters||Standard Deviation|Mean
133475|NCT00527826|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.|Baseline and Week 52|ITT Population||percent of predicted value||Standard Deviation|Mean
133476|NCT00527826|Secondary|Mean Number of Days Rescue Medication Was Used|Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.|The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])|ITT Population with non-missing data (due to early withdrawal, some data for this outcome measure are missing).||number of days||Standard Deviation|Mean
133477|NCT00527826|Secondary|Number of Participants With the Indicated Number of Hospital Stays|The number of participants with the indicated number of hospitalizations was recorded.|Baseline through Week 52|ITT Population||participants|||Number
133478|NCT00527826|Secondary|Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)|The number participants with the indicated number of days at the ICU was recorded.|Baseline through Week 52|ITT Population of participants who were admitted to the ICU||participants|||Number
133479|NCT00527826|Secondary|Mean Number of COPD-related Visits at/by Physician|The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.|Baseline through Week 52|ITT Population with non-missing data (due to early withdrawal some data for this outcome measure are missing)||number of visits||Standard Deviation|Mean
133480|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Poisson Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|ITT Population||Number of exacerbations per year||Standard Error|Least Squares Mean
133481|NCT00527826|Secondary|Compliance and Adherence to Study Medication|Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.|Baseline through Week 52|ITT Population||percentage of doses||Standard Deviation|Mean
133482|NCT00527826|Primary|Mean Number of Exacerbations Per Year: Negative Binomial Model|During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.|Baseline through Week 52|Intent-to-Treat (ITT) Population: all participants receiving at least one dose of study medication and suffering from COPD||Number of exacerbations per year||Standard Error|Least Squares Mean
133544|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Tmax|The time for maximal concentration (tmax) was determined for data up to Day 42|Day 0-42|||Days||Standard Deviation|Mean
133545|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: Cmax|Cmax was determined for concentration measurements up to Day 42|Day 0-42|||ng/mL||Standard Deviation|Mean
133483|NCT00527787|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
133484|NCT00527787|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
133485|NCT00527787|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|baseline to 6 Months|Intent to Treat (ITT) Population||Units on SODA Subscale||Standard Error|Least Squares Mean
133486|NCT00527787|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat (ITT) Population||Participants|||Number
133487|NCT00527787|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population||participants|||Number
133488|NCT00527787|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population||Participants|||Number
133489|NCT00527787|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intention to Treat (ITT) Population||Participants|||Number
133490|NCT00527787|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population||Participants|||Number
133491|NCT00527787|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population||Participants|||Number
133492|NCT00527735|Secondary|Overall Survival in Participants With SCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Median
133493|NCT00527735|Secondary|Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with SCLC who had at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.||Participants|||Number
133494|NCT00527735|Secondary|Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.||Participants|||Number
139119|NCT00476788|Secondary|Adverse Event Frequency||6.9 months (average)|||events|||Number
133495|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Mean
133496|NCT00527735|Secondary|Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN. Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study pancreatic enzyme or other laboratory test measurement available.||Percentage of participants|||Number
133497|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade|ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. ULN=Upper limit of normal among all laboratory ranges. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study liver function test result available.||Participants|||Number
133498|NCT00527735|Secondary|Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment|All participants with SCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study hematology test result available.||Participants|||Number
133499|NCT00527735|Secondary|Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with SCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin.||Participants|||Number
133500|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline|An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum. Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose. Positive status postbaseline=participants with an increase in HAHA measurement from baseline.|Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|Participants with at least 1 HAHA measurement prior to and at least 1 after the first ipilimumab dose and with an increase in HAHA measurement from baseline.||Participants|||Number
133501|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade|ULN=upper limit of normal. Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study pancreatic enzyme laboratory test measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Percentage of participants|||Number
133502|NCT00527735|Secondary|Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings|Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. Physical examinations assessed weight, height, performance status, and body surface area.|At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study measurement available.One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Participants|||Number
133511|NCT00527735|Secondary|Overall Survival in Participants With NSCLC|Overall Survival is defined as the time from the date of randomization until the date of death. For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.|Randomization date to date of death (of censored, maximum reached: 26.5 months)|All NSCLC participants who were randomized to a treatment group.||Months||95% Confidence Interval|Median
133503|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.|At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab and/or chemotherapy and had at least 1 on-study liver function measurement available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Participants|||Number
133504|NCT00527735|Secondary|irPFS in Participants With SCLC Per irRC|IRC performed TA.|Randomization date to date of irPD or death (maximum reached: 22 months)|All participants with SCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Mean
133505|NCT00527735|Secondary|Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade|CTC, Version 3 used to assess parameters. LLN=lower limit of normal. CTC criteria: ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent|All participants with NSCLC who received at least 1 dose of ipilimumab/placebo and/or chemotherapy and had at least 1 on-study hematology test result available. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Percentage of participants|||Number
133506|NCT00527735|Secondary|Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)|All participants with NSCLC who received at least 1 dose of blinded active or placebo ipilimumab with or without paclitaxel/carboplatin. One NSCLC participant randomized to the sequential arm is included in the concurrent arm for safety evaulations.||Participants|||Number
133507|NCT00527735|Secondary|Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC|irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first. For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment. By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first. For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.|Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)|All participants who were randomized to a treatment group.||Months||95% Confidence Interval|Median
133508|NCT00527735|Secondary|Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC|irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set. irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease. By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set. SD=A decrease or tumor stabilization of 1 or more nonindex lesions. Independent review committee assessed response.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)|All participants who were randomized to a treatment group.||Percent of participants||95% Confidence Interval|Number
133509|NCT00527735|Secondary|Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)|irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set. irCR=Complete disappearance of all index lesions. irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions. Independent review committee performed the tumor assessments.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.||Percentage of participants||95% Confidence Interval|Number
133510|NCT00527735|Secondary|Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC|mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage). CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions. Independent review committee performed tumor assessment.|Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance|All participants who were randomized to a treatment group.||Percentage of participants||95% Confidence Interval|Number
133542|NCT00527514|Secondary|Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure||Baseline to 12 weeks|The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants.||mm Hg||Standard Deviation|Mean
133512|NCT00527735|Secondary|Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria|By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first. For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization. A participant who died without reported prior progression was considered to have progressed on the date of death. For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)|All NSCLC participants who were randomized to a treatment group.||Months||95% Confidence Interval|Mean
133513|NCT00527735|Primary|Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)|irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.|Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)|All participants with NSCLC who were randomized to a treatment group.||Months||95% Confidence Interval|Median
133514|NCT00527722|Primary|Number of Participants With Absence of Pneumothoraces|Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).|X-Rays at 0-60 minutes, 24 hours and 30 days|Intent-to-treat (ITT) population of all subjects who were randomized.||Participants|||Number
133515|NCT00527618|Secondary|Sub-Study: To Evaluate the Kinetics of Plasma HIV-1 Decline Over the First Three Days of High-dose Valacyclovir Administration.|Plasma HIV-1 RNA was measured one day prior to, at initiation, and at 6, 24, 48, and 72 hours after initiating valacyclovir. Measurements at 24, 48, and 72 hours were used to determine the rate of HIV-1 RNA decline.|72 hours|In April 2010, we invited participants, including those who already completed the study, to participate in the substudy. Two participants had plasma HIV-1 RNA <40 copies/mL at the time of valacyclovir initiation and were excluded from analysis.||log10 copies/mL/day||95% Confidence Interval|Mean
133516|NCT00527618|Secondary|The Safety of Valacyclovir 1 Gram Orally Twice Daily in HIV-1 Seropositive Persons.||12 weeks||||||
133517|NCT00527618|Secondary|The Effect of Valacyclovir 1 g Twice Daily Compared With Acyclovir 400 mg Twice Daily on the Quantity of Genital HSV Detected During Shedding Episodes.|HSV DNA was quantitated from daily self-collected genital swabs for the four weeks of each drug intervention. The quantity of genital HSV DNA present, when HSV DNA was detected, was compared.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.||log10 copies/mL||Full Range|Median
133518|NCT00527618|Secondary|The Effect of Valacyclovir 1 Gram Twice Daily Compared to Acyclovir 400 mg Twice Daily on the Percentage of Days With Genital Herpes Lesions.|The percentage of days with genital herpes lesions was determined by the combined diary days in which genital lesions were recorded divided by the combined number of diary days for participants in the first four weeks of each drug intervention, multiplied by 100.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.||percentage of days with genital lesions|||Number
133519|NCT00527618|Primary|The Genital HSV Shedding Rate While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|HSV DNA quantitated from daily self-collected genital swabs for the first four weeks of each drug intervention. The shedding rate was determined by the combined number of swabs with HSV detected divided by the combined number of swabs collected from participants, multiplied by 100.|The first four weeks of each intervention|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants.||percentage of swabs collected with HSV|||Number
133520|NCT00527618|Primary|The Quantity of HIV-1 RNA in Plasma While on 400 mg Twice Daily of Acyclovir Versus 1000 mg Twice Daily of Valacyclovir.|Weekly measurements of plasma HIV-1 RNA on each drug were compared. The primary analysis was of the average difference in plasma HIV-1 RNA on valacyclovir and acyclovir as determined by a linear mixed model. The median of the average per-participant plasma HIV-1 RNA levels on valacyclovir and valacyclovir is also listed.|26 weeks (12 weeks per drug intervention)|Of the 34 participants who were randomized, 6 participants did not contribute to both arms of the study. The final analysis set therefore included 28 participants. 27 participants had plasma HIV-1 RNA levels available for analysis, since samples for one participant were persistently inhibited.||log10 copies/mL||Full Range|Median
133521|NCT00527605|Secondary|Change From Baseline in Qmax at Month 3|Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||ml/s||Standard Deviation|Mean
133522|NCT00527605|Secondary|Change From Baseline in Qmax at Month 6|Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||milliliters/second (ml/s)||Standard Deviation|Mean
133523|NCT00527605|Secondary|Percent Change From Baseline in Qmax at Month 3|Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change||Standard Deviation|Mean
133524|NCT00527605|Secondary|Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6|Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||percent change||Standard Deviation|Mean
133525|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 3|Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||points on a scale||Standard Deviation|Mean
133526|NCT00527605|Secondary|Change From Baseline in the AUA-SI Score at Month 6|Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||points on a scale||Standard Deviation|Mean
133527|NCT00527605|Secondary|Percent Change From Baseline in the AUA-SI Score at Month 3|Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change||Standard Deviation|Mean
133528|NCT00527605|Secondary|Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6|Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||percent change||Standard Deviation|Mean
133529|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 3|Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||pg/ml||Standard Deviation|Mean
133530|NCT00527605|Secondary|Change From Baseline in the Serum DHT at Month 6|Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||picograms/milliliter (pg/ml)||Standard Deviation|Mean
133531|NCT00527605|Secondary|Percent Change From Baseline in the Serum DHT at Month 3|Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change||Standard Deviation|Mean
133532|NCT00527605|Secondary|Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6|Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||percent change||Standard Deviation|Mean
133533|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 3|Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||cubic centimeters||Standard Deviation|Mean
133534|NCT00527605|Secondary|Change From Baseline in the Prostate Volume at Month 6|Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|ITT Population. Some participants were missing Month 6 measurements.||cubic centimeters||Standard Deviation|Mean
133535|NCT00527605|Secondary|Percent Change From Baseline in the Prostate Volume at Month 3|Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 3|ITT Population. Some participants were missing Month 3 measurements.||percent change in volume||Standard Deviation|Mean
133536|NCT00527605|Primary|Percent Change From Baseline in the Prostate Volume at Month 6|Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements.||percent change in volume||Standard Deviation|Mean
133537|NCT00527592|Primary|Comfort Immediately After Dosing|Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.|5 seconds|Intent to treat: All patients who received test article and completed the trial.||Units on a scale|Participants|Standard Deviation|Mean
133538|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end end of week 12|ITT (efficacy cohort)||mm Hg||Standard Error|Mean
133539|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 9|ITT (efficacy cohort)||mm Hg||Standard Error|Mean
133540|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 6|ITT (efficacy cohort)||mm Hg||Standard Error|Mean
133541|NCT00527514|Secondary|Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group.|Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis.|Baseline to end of week 3|ITT (efficacy cohort)||mm Hg||Standard Deviation|Mean
140356|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 1|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 1|on-study week 5|||ng/mL||Standard Deviation|Mean
133546|NCT00527488|Primary|Interntional Iindes of Erectile Function (IIEF) Score: Overall Satisfaction|The IIEF contains 15 items in 5 domains: Erectile Function (6 items), Orgasmic Function (2 items), Sexual Desire (2 items), Intercourse Satisfaction (3 items), and Overall Satisfaction (2 items). Item are scored on a scale from ‘No sexual activity’ to ‘Almost always to always’. For the Erectile Function domain, a score of 1-10 indicates severe erectile dysfunction and 26-30 no dysfunction, the minimum score being 1 and the maximum 30. For all other domains, a higher score indicates less dysfunction. The IIEF does not yield a total score.|Day 0-42|||Units on a scale||Standard Deviation|Mean
133547|NCT00527488|Primary|IPSS Global Quality of Life|"Patients were asked about how they would feel if they were to spend the rest of their lives with their prostate symptoms just as they are now. The answers choices range from delighted to terrible or 0 to 6."|Day 0-42|||Units on a scale||Standard Deviation|Mean
133548|NCT00527488|Primary|International Prostate Specific Symptom (IPSS) Score|The IPSS is a patient-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (0-7: mildly symptomatic; 8-19: moderately symptomatic; 20-35: severely symptomatic).|Day 0-42|||Units on a scale||Standard Deviation|Mean
133549|NCT00527488|Primary|Post-void Residual Urine Volume|The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically.|Day 0-42|||mL||Full Range|Mean
133550|NCT00527488|Primary|Maximal Urinary Flow|Urinary flow was determined by flowmetry using a device that fulfils the International Continence Society standards for maximum urinary flow.|Day 0-42|||mL/s||Standard Deviation|Mean
133551|NCT00527488|Primary|Prostate Volume|The prostatic volume was measured by transrectal ultrasound. The prostatic gland was sonicated from two directions perpendicular to one another resulting in three cursor positions set by the urologist, and the volume automatically calculated.|Day 0-42|||mL||Standard Deviation|Mean
133552|NCT00527488|Primary|Prostate Specific Antigen (PSA) Concentration||Day 0-42|||ng/mL||Standard Deviation|Mean
133553|NCT00527488|Primary|Number of Subjects With Testosterone Concentration at or Above the Baseline Interval Concentration|The baseline interval concentration is 0.75 x baseline concentration|Day 0-42|||participants|||Number
133554|NCT00527488|Primary|Number of Subjects With Testosterone Concentration ≤0.5 ng/mL||Day 0-42|||participants|||Number
133555|NCT00527488|Primary|Duration of Testosterone Concentration Below 0.5 ng/mL|The time from when the testosterone concentration falls below 0.5 ng/mL until it returns above that level|Day 0-42|||Days||Full Range|Median
133556|NCT00527488|Primary|Time of Minimal Value of Testosterone (Tnadir)|The time point when the lowest testosterone concentration was measured|Day 0-42|||Days||Standard Deviation|Mean
133557|NCT00527488|Primary|Minimal Value of Testosterone (Cnadir)|The lowest concentration of testosterone measured within the time frame|Day 0-42|||ng/mL||Standard Deviation|Mean
133558|NCT00527488|Primary|Time of Testosterone Concentration Below Baseline Interval|The time from when the testosterone concentration falls below the baseline interval limit (i.e. 0.75 x baseline concentration) until it returns above this limit|Day 0-42|||Days||Standard Deviation|Mean
133559|NCT00527488|Secondary|Pharmacokinetic Parameters of Degarelix: AUCt|Area under the time-concentration curve (AUCt) was calculated by non-compartmental methods based on data up to Day 42|0-42 Days|||ng*day/mL||Standard Deviation|Mean
133560|NCT00527488|Primary|Testosterone Area Below Baseline Interval|The area of the testosterone concentration (ng/mL) vs. time (days) curve that is below the baseline interval concentration( i.e. 0.75 x baseline concentration)|0-42 Days|||ng*days/mL||Standard Deviation|Mean
133561|NCT00527475|Secondary|The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months.||1 year||||||
133562|NCT00527475|Primary|The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.||1 year|Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events.||percentage of participants|||Number
133563|NCT00527423|Secondary|Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline of original study to Wk 156|||letters read||Standard Deviation|Mean
133564|NCT00527423|Secondary|Frequency (Number of Injections)|Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).|Baseline of this study to Wk 152|A total of 1116 PRN injections were administered into the study eyes of 135 participants between baseline of this study to Week 152 (end of treatment). Of the 157 enrolled participants, 22 received no injections, and 15 received 1 injection.||Injections||Full Range|Median
133565|NCT00527423|Primary|Number of Participants With Adverse Events (AE)|Number of participants with AEs summarized by category|Baseline of this study to Wk 152|||participants|||Number
133566|NCT00527397|Primary|Self-Monitoring Blood Glucose Levels: Change From Baseline|Self-monitoring blood glucose levels obtained at each observation point minus that at baseline.|One year|This endopoint was not analyzed because of small numbers of subjects due to early termination||milligram/millilitre||Standard Deviation|Mean
133567|NCT00527397|Secondary|Insulin Antibody Levels : Change From Baseline|Insulin antibody levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||microunit/milliliter||Standard Deviation|Mean
133592|NCT00526799|Secondary|Duration of Stable Disease|To determine duration of stable disease, in months|From enrollment until treatment discontinuation. Participants may remain on study drug indefinitely|||months||95% Confidence Interval|Median
133568|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second/Forced Vital Capacity:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second/forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.||liter/liter||Standard Deviation|Mean
133569|NCT00527397|Secondary|The Values of Forced Vital Capacity:Change From Baseline|pulmonary function test(forced vital capacity) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 1, Week 2, Week 6, Week 12, Week 26, End of treatment|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.||liter||Standard Deviation|Mean
133570|NCT00527397|Secondary|The Values of Forced Expiratory Volume at 1 Second:Change From Baseline|Pulmonary function test(forced expiratory volume at 1 second) obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Beseline, Week 1, Week 2, Week 6, Week 12, Week 26|Included all subjects who had a baseline forced expiratory volume at 1 second value, had at least one-post baseline forced expiratory volume at 1 second values, and received at least one dose of study drug.||liter||Standard Deviation|Mean
133571|NCT00527397|Secondary|The Incidence of Hypoglycaemia at the Cumulative Doses of Inhaled Insulin|Number of hypoglycemic events per subject-month. Subject-month=(number of days from the first day of study treatment to the last day of active treatment + 1 day lag)/30.44|0 month to 12 months|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||events / subject-month|||Number
133572|NCT00527397|Secondary|The Value of Fasting Plasma Glucose:Change From Baseline|Fasting plasma glucose levels obtained at each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||milligram/millilitre||Standard Deviation|Mean
133573|NCT00527397|Secondary|The Values of Hemoglobin A1c:Change From Baseline|Hemoglobin A1c levels obtained each observation point minus that at baseline. The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Baseline, Week 6, Week 12, Week 26, End of treatment|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||percent||Standard Deviation|Mean
133574|NCT00527397|Secondary|Daily Inhaled Insulin Dose|The mean of daily inhaled insulin dose. The dose of inhaled insulin was adjusted based on the results of self-monitoring of blood glucose before each meal.The end of treatment values were calculated each subject's last observed value up to 26 weeks.|Up to 26 weeks|Includes all subjects who received at least one dose of study drug. Number of subjects with evaluable data presented as n=type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus Using Insulin, Type 2 Diabetes Mellitus Not Using Insulin, respectively.||milligram||Standard Deviation|Mean
133575|NCT00527332|Secondary|Health-related Economy.||Within 6 months after the surgery||||||
133576|NCT00527332|Secondary|The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.||Within 6 months after the surgery||||||
133577|NCT00527332|Secondary|Sick Leave.||Within 6 months after the surgery||||||
133578|NCT00527332|Secondary|Quality of Life and QALYs (Quality Adjusted Life Years).||Within 6 months after the surgery||||||
133579|NCT00527332|Secondary|Complications and Complication Rates.||Within 6 months after the surgery||||||
133580|NCT00527332|Secondary|Postoperative Consumption of Analgesics and Antiemetics.||Within 6 months after surgery||||||
133581|NCT00527332|Secondary|Occurrence and Degree of Postoperative Symptoms.||Within 6 months after the surgery||||||
133582|NCT00527332|Primary|Duration of Hospital Stay.|Duration of hospital stay defined as time from start anesthesia to leaving the hospital|Within 6 months after surgery|Participants who completed the study were analyzed||Hours||Full Range|Median
133583|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength||4 weeks|||participants|||Number
133584|NCT00527319|Primary|Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass||4 weeks|||participants|||Number
133585|NCT00526890|Primary|Incidence of Grade 3-4 Myelosuppression||During study treatment|Patients Treated with Study Therapy||percentage of participants||95% Confidence Interval|Number
133586|NCT00526890|Secondary|Correlation of Selenium Levels With Degree of Observed Adverse Events|Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events. There was no significant correlation between selenium levels and serious adverse events (P=0.3149)|Pre-treatment and every week for 6 weeks prior to chemotherapy.||||||
133587|NCT00526890|Secondary|Overall Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter|Patients treated with study therapy||months||95% Confidence Interval|Median
133588|NCT00526890|Secondary|Failure-free Survival||Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter.|Patients treated with study therapy||months||95% Confidence Interval|Median
133589|NCT00526890|Secondary|Response Rate||1 month post-treatment, then q 3 months x 4|||percentage of patients||95% Confidence Interval|Number
133590|NCT00526890|Primary|Incidence of Grade 3-4 Pneumonitis||During Study Treatment|Patients treated with study therapy||percentage of participants||95% Confidence Interval|Number
133591|NCT00526890|Primary|Incidence of Grade 3-4 Esophagitis||During study treatment|Treated with Study Therapy||percentage of participants||95% Confidence Interval|Number
133595|NCT00526799|Primary|Percentage of Participants With Response|"To assess response in patients with recurrent or resistant epithelial ovarian cancer treated with Sorafenib plus Topotecan. Reponse evaluated per RECIST criteria where:~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Disease assessments were conducted on the 8th week (Cycle 2, Week 4) and every eight weeks there after, until treatment discontinuation|||percentage of participants|||Number
133596|NCT00526799|Primary|Maximum Tolerated Dose (MTD)|An initial 3 patients will be enrolled at dose level 1. If all 3 patients in dose level 1 complete the first cycle of therapy without a dose limiting toxicity (DLT), 3 patients will be enrolled at dose level 2. If 0 of 3 or 1 of 6 patients in dose level 2 experience a DLT, all subsequent patients will be enrolled in the Phase II cohort at dose level 2. If 2 of the first 3 or 2 of the total 6 patients experience DLT at dose level 2, then dose level 1 will be considered the MTD and used in the second phase.|Each participant was treated at their assigned dose level on 28 day cycles until disease progression or unacceptable toxicity. Participants were evaluated for toxicity every two weeks.|Of the 16 patients enrolled in the phase I study, five were not evaluable for MTD determination due to intercurrent illnesses interfering with toxicity assessment or withdrawal and were replaced or excluded.||mg/day|||Number
133597|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points|Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (<LLN to 3000/mm^3 of blood plasma [bp]), mild; G 2 (<3000 to 2000/mm^3 of bp), moderate; G 3 (<2000 to 1000/mm^3 of bp), severe; G 4 (<1000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133598|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points|Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (<LLN to 75000/mm^3 of blood plasma [bp]), mild; G 2 (<75000 to 50000/mm^3 of bp), moderate; G 3 (<50000 to 25000/mm^3 of bp), severe; G 4 (<25000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133599|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points|Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (<LLN to 1500/millimeters cubed [mm^3] of blood plasma [bp]), mild; G 2 (<1500 to 1000/mm^3 of bp), moderate; G 3 (<1000 to 500/mm^3 of bp), severe; G 4 (<500/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133600|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points|Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133601|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points|Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (<LLN to 10 g/dL), mild; G 2 (<10.0 to 8.0 g/dL), moderate; G 3 (<8.0 to 6.5 g/dL), severe; G 4 (<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133628|NCT00526630|Primary|The Primary Outcome Measure Was Change in Gait Velocity Between Groups at 12 and 27 Weeks.|"Gait velocity is a measure of distance over time in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27|||centimeters/second||Standard Deviation|Mean
133602|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points|Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (>ULN to 150 mmol/L; <LLN to 130 mmol/L), mild; G 2 (>150 to 155 mmol/L; value not available), moderate; G 3 (>155 to 160 mmol/L; <130 to 120 mmol/L), severe; G 4 (>160 mmol/L; <120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133603|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points|Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (>ULN to 3.0 mg/dL; <LLN to 1.2 mg/dL), mild; G 2 (value not available; <1.2 to 0.9 mg/dL), moderate; G 3 (>3.0 to 8.0 mg/dL; <0.9 to 0.7 mg/dL), severe; G 4 (>8.0 mg/dL; <0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133604|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low [per blood samples], respectively): G 1 (>ULN to 5.5 millimoles per liter [mmol/L]; <LLN to 3.0 mmol/L), mild; G 2 (>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (>6.0 to 7.0 mmol/L; <3.0 to 2.5 mmol/L), severe; G 4 (>7.0 mmol/L; <2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133605|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points|Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (>ULN to 160 mg/dL; <LLN to 55 mg/dL), mild; G 2 (>160 to 250 mg/dL; <55 to 40 mg/dL), moderate; G 3 (>250 to 500 mg/dL; <40 to 30 mg/dL), severe; G 4 (>500 mg/dL; <30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133606|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points|Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 6.0x ULN), severe; G 4 (>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133607|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points|Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (<LLN to 8.0 mg/dL; >ULN to 11.5x ULN), mild; G 2 (<8.0 to 7.0 mg/dL; >11.5 to 12.5 ULN), moderate; G 3 (<7.0 to 6.0 mg/dL; >12.5 to 13.5 mg/dL), severe; G 4 (<6 mg/dL; >13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133608|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points|Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 10.0x ULN), severe; G 4 (>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133783|NCT00525824|Secondary|Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133609|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points|Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133610|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133611|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points|Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal [ULN] to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133612|NCT00526669|Secondary|Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points|Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (<lower limit of normal [LLN] to 3 grams per deciliter [g/dL]), mild; G 2 (<3 to 2 g/dL), moderate; G 3 (<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.|Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy|Safety Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants with data available at the specified time points were evaluated.||participants|||Number
133613|NCT00526669|Secondary|Number of Participants in the Indicated Categories for Best Overall Response (BOR)|Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population||participants|||Number
133614|NCT00526669|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first.|From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks)|ITT Population. Duration of response was estimated for only the subset of participants who had response. Duration of response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||95% Confidence Interval|Median
133615|NCT00526669|Secondary|Time to Response|Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point.|Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)|ITT Population. Time to response was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||Inter-Quartile Range|Median
133616|NCT00526669|Secondary|Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||Inter-Quartile Range|Median
133617|NCT00526669|Secondary|Time to Progression (All Deaths Are Treated as Competing Risk)|Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. Time to progression was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||Inter-Quartile Range|Median
133618|NCT00526669|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication.|From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)|ITT Population. OS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||95% Confidence Interval|Median
133619|NCT00526669|Secondary|PFS|PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact).|From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||weeks||95% Confidence Interval|Median
133620|NCT00526669|Primary|Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)|5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of >=1 NL and/or unequivocal progression of existing non-TLs, and a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.|From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)|ITT Population. PFS was censored for participants who did not have an event before data cut off. The last available assessment prior to the data cut off was used for censored participants.||percentage of participants|||Number
133621|NCT00526669|Primary|Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])|Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as >= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.|From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)|ITT Population||percentage of participants|||Number
133622|NCT00526669|Primary|Change From Start of Run-in Period in Biomarker Expression Levels at Day 0|Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.|evaluated at baseline and after 7 days of study treatment|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of lapatinib. Only those participants contributing viable samples were analyzed. Different participants contributed samples for different biomarkers.||ratio||Full Range|Median
133623|NCT00526630|Secondary|The 5-item EuroQoL (EQ-5D) Quality of Life Generic Instrument Between Groups at 12 and 27 Weeks.|The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The range is from 0 to 100, with 100 indicating the best health status.|Week 12 and 27|||units on a scale||Standard Deviation|Mean
133624|NCT00526630|Secondary|The Epworth Sleepiness Scale (ESS) Between Groups at 12 and 27 Weeks|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0–9 range is considered to be normal while a number in the 10–24 range indicates excessive daytime sleepiness. Higher scores imply worse sleepiness.|Week 12 and 27|||units on a scale||Standard Deviation|Mean
133625|NCT00526630|Secondary|Montgomery–Åsberg Depression Rating Scale (MADRS) Between Groups at 12 and 27 Weeks.|MADRS is a questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60|Week 12 and 27|||units on a scale||Standard Deviation|Mean
133626|NCT00526630|Secondary|Freezing of Gait Questionnaire (FOGQ) Scores Between Groups at 12 and 27 Weeks.|FOGQ is a questionnaire that quantifies severity of gait and falls. It contains 16 items with a 0-4 severity scale for each, for a range of 0 (normal) to 64 (most severe impairment).|Week 12 and 27|||units on a scale||Standard Deviation|Mean
133627|NCT00526630|Secondary|Duration of Freezing and Shuffling Episodes Between Groups at 12 and 27 Weeks.|Freezing and shuffling are measures of ambulatory impairment.|Week 12 and 27|||hours||Standard Deviation|Mean
133629|NCT00526630|Primary|The Primary Outcome Measure Was Change in a Gait Stride Length Between Groups at 12 and 27 Weeks.|"Gait stride length is the distance between two consecutive steps in the on state. This will be measured by the GAITRite System, which is an electronic walkway utilized to measure the temporal (timing) and spatial (two dimension geometric position) parameters of its pressure activated sensors."|Week 12 and 27|||centimeters||Standard Deviation|Mean
133630|NCT00526630|Secondary|The Unified Parkinson Disease Rating Scale (UPDRS) Between Groups at 12 and 27 Weeks|Patients will have a mild to severe gait disturbance with score >1 on the motor subscale of the Unified Parkinson’s disease rating scale (UPDRS) but without need for a continuous ambulatory aid such as walker or wheelchair (Hoehn & Yahr 2-3). The highest score possible for the UPDRS is 108 which indicates severe motor impairment. The lowest score for the UPDRS is 0 which indicates no motor impairment.|At week 12 and 27|||units on a scale||Standard Deviation|Mean
133631|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133632|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133633|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133634|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133635|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133636|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133637|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133784|NCT00525824|Secondary|Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment|Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133638|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133639|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133640|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR, or UH-VCIN . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133641|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or first occurrence of an MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Partcipants|||Number
133642|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133643|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the TIMI Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug||Percentage of Participants|||Number
133644|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Met GUSTO Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.|up to 3 years|Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug||Percentage of Participants|||Number
133785|NCT00525824|Secondary|Percent Change in TC/HDL-C After 6 Weeks Combination Treatment|Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133645|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA||Percentage of Participants|||Number
133646|NCT00526474|Post-Hoc|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intended Label Population: all enrolled participants with coronary arterial disease (CAD) or peripheral arterial disease (PAD) and no history of a stroke or transient ischemic attack (TIA)||Percentage of Participants|||Number
133647|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of a revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133648|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133649|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization|The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133650|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization|The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133651|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133652|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133854|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
133653|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization|The time (in days) from study start to CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133654|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133655|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization|The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133656|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133657|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization|The time (in days) from study start to the occurrence of CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133658|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization|The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Perentage of Participants|||Number
133659|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. “Clinically Significant Bleeding” was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
133686|NCT00526097|Secondary|Change From Baseline for Potassium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||mmol/L||Standard Deviation|Mean
133660|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization|Adverse events were categorized as “bleeding events” if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.|up to 3 years|As Treated Population, which included all participants who received at least 1 dose of study medication.||Percentage of Participants|||Number
133661|NCT00526474|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.|up to 3 years|ITT Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133662|NCT00526474|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization|The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.|up to 3 years|Intent to Treat (ITT) Population, defined as all participants who were randomly assigned to a treatment arm.||Percentage of Participants|||Number
133663|NCT00526331|Primary|Length of Hospital Stay (LOS) by Participant|Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.|From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)|Study terminated by sponsor without analysis due to technical reasons.||days|||Number
133664|NCT00526292|Primary|Treatment Efficacy as Defined by Complete or Partial Remission||3 Months following treatment|||participants|||Number
133665|NCT00526227|Secondary|Adverse Events|A total of 62 Adverse Events were reported in 43 subjects.|1 Month|||participants|||Number
133666|NCT00526227|Secondary|Describe System Performance|System performance was assessed by reviewing Holter records, Save to disk files and technical observation. Only descriptive statistics were presented, no comparative measure was analyzed. 21 24-hour digital Holter records were review. 140 Save to Disk Files was reviewed. No anomalies were found. The device performed as intended.|1 month|||participants|||Number
133667|NCT00526227|Primary|Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.|Only subjects implanted with a Secura device that were followed at least 28 days post-implant, or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month|Seventy-nine subjects completed at least one-month (28 days)of follow-up post-implant and were included in the analysis. One subject died prior to the 1-month follow-up.||Percentage of participants|||Number
133668|NCT00526188|Secondary|Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points|Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and combined pre- and post- contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion characterization in the Standard of reference (SOR)||Percentage points||95% Confidence Interval|Mean
133669|NCT00526188|Secondary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points|The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set, with at least 1 lesion in the Standard of Reference (SOR).||Percentage points||95% Confidence Interval|Mean
133687|NCT00526097|Secondary|Change From Baseline for Sodium (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||mmol/L||Standard Deviation|Mean
133670|NCT00526188|Primary|Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points|Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.|Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).|All participants from the per protocol set with pre- and post-contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion in the Standard of Reference (SOR)||Percentage points||95% Confidence Interval|Mean
133671|NCT00526162|Secondary|Adverse Events|A total of 70 Adverse Events were reported in 44 subjects.|1 month|||participants|||Number
133672|NCT00526162|Secondary|Describe System Performance|System performance was assessed by reviewing Holter records, Save to disk files and technical observations. Only descriptive statistics were presented,no comparative measure was analyzed. 20 24-hour Holter records and 94 Save to Disk Files were reviewed. 3 minor anomalies were found, and were deemed acceptable. There was no patient safety risk.|1 month|The device performed as intended.||participants|||Number
133673|NCT00526162|Primary|Percentage of Subjects With an Unanticipated Serious Adverse Device Effects at 1-Month Post Implant.|Only subjects implanted with a Consulta device that were followed at least 28 days post-implant, or have had a unanticipated device effect within 28 days after implant were included in the analysis.|1 month|||percentage of participants|||Number
133674|NCT00526123|Secondary|Reliability of the Catheter|Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.|35 Weeks|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had the study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of study visits||Standard Deviation|Mean
133675|NCT00526123|Secondary|Primary Failure Rate|The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session.|First dialysis session with study catheter|Number of participants was derived from the 'per protocol' population defined as those subjects that were randomized, had a study catheter inserted, and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of catheters|||Number
133676|NCT00526123|Secondary|Frequency of Clinician Interventions for Catheter Malfunction and Infection|Average number of times clinician intervention was required for either catheter malfunction or infection|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||events||Standard Deviation|Mean
133677|NCT00526123|Secondary|Average Number of Line Reversals Per Subject|Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments|35 Weeks|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||events||Standard Deviation|Mean
133678|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|245 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of participants|||Number
133679|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|60 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of participants|||Number
133680|NCT00526123|Secondary|Inadequate Flow Rates Requiring Surgical/Radiological Intervention|Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.|35 weeks|Number of participants is derived from the 'intent to treat' population defined as those subjects that were randomized.||events|||Number
133681|NCT00526123|Primary|First Catheter Induced Complication|% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.|30 days|Number of participants is derived from the 'per protocol' population defined as those subjects that were randomized and have at least one post baseline measurement for the primary efficacy endpoint.||percentage of participants|||Number
133682|NCT00526110|Secondary|Median Overall Survival|Overall survival was defined as the time from the start of treatment until death or last follow-up. Kaplan-Meier curve was used to estimate overall survival.|Up to 30 months|||months||Full Range|Median
133683|NCT00526110|Primary|Progression Free Survival|Progression Free Survival (PFS) defined as the time from the first study drug administration until the first day of radiological and/or symptomatic disease progression is documented, or the start of further anticancer therapy or death from any cause, whichever occurs first. Kaplan-Meier curve was used to estimate PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.|Assessed from baseline to 30 months|||months||95% Confidence Interval|Median
133684|NCT00526110|Primary|Maximum Tolerated Dose (MTD)|MTD is the highest dose at which 1 or fewer dose limiting toxicities (DLT’s) are observed in 6 patients. DLT defined as any non-hematologic grade III/IV or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy. Response evaluated after two 14-day treatments of Docetaxel, 5-Fluorouracil and Oxaliplatin (One cycle = 28 days).|28 days|||mg/m^2|||Number
133685|NCT00526097|Secondary|Change From Baseline for Chloride (Normalized Value)|Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range|Baseline and 4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||mmol/L||Standard Deviation|Mean
133688|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Overall Score|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133689|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Satisfaction'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133690|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133691|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133692|NCT00526097|Secondary|Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'|The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133693|NCT00526097|Secondary|Change From Baseline in the SF-36 Physical Component Scale (PCS)|The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133694|NCT00526097|Secondary|Change From Baseline in the SF-36 Mental Component Scale (MCS)|The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133695|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Mental Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133696|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'|The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133697|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Social Functioning'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133698|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Vitality'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133699|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'General Health'|The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133745|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133700|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Bodily Pain'|The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133701|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'|The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133702|NCT00526097|Secondary|Change From Baseline in the SF-36 Dimension 'Physical Functioning'|The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health.|Baseline and 4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133703|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||Participants|||Number
133704|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure||Participants|||Number
133705|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133706|NCT00526097|Secondary|Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator|Final global assessment scale range: 1 (good) to 4 (bad), ordinal|4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133707|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133708|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133709|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133710|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133711|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133746|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133712|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133713|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133714|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133715|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133716|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133717|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133718|NCT00526097|Secondary|Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline|Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133719|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133720|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 3 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133721|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133747|NCT00526097|Secondary|Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133722|NCT00526097|Secondary|Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline|Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline|Baseline and week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133723|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133724|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133725|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133726|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133727|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133728|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133729|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133730|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133731|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133732|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133733|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133734|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1|The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133735|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133736|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133737|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133738|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1|The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133739|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133740|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133741|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133742|NCT00526097|Secondary|Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1|The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week.|Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Score on a scale||Standard Error|Least Squares Mean
133743|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133744|NCT00526097|Secondary|Number of Participants Using Rescue Medication at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133748|NCT00526097|Secondary|Number of Premature Withdrawals at Week 4 in the Treatment Period||Week 4 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133749|NCT00526097|Secondary|Number of Premature Withdrawals at Week 3 in the Treatment Period||Week 3 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133750|NCT00526097|Secondary|Number of Premature Withdrawals at Week 2 in the Treatment Period||Week 2 in the treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133751|NCT00526097|Secondary|Number of Premature Withdrawals at Week 1 in the Treatment Period||Week 1 in the treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133752|NCT00526097|Secondary|Number of Premature Withdrawals Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133753|NCT00526097|Secondary|Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133754|NCT00526097|Secondary|Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period||4 weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133755|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline||Baseline and week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133756|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline||Baseline and week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133757|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline||Baseline and week 2 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133758|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline||Baseline and week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133759|NCT00526097|Secondary|Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline||Baseline and 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Participants|||Number
133760|NCT00526097|Secondary|Time to the First SBM Following the First Dose of Study Medication (SM)|The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal.|Time of first dose of SM up to 4 weeks|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||Hours||95% Confidence Interval|Median
133761|NCT00526097|Secondary|Number of SBMs at Week 4|The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
133762|NCT00526097|Secondary|Number of SBMs at Week 3|The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
133763|NCT00526097|Secondary|Number of SBMs at Week 2|The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
133764|NCT00526097|Secondary|Number of SBMs at Week 1|The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
140357|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 1|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 1|on-study week 5|||ng/mL||Standard Deviation|Mean
133765|NCT00526097|Secondary|Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period|A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.|4 Weeks|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||SBMs per week||Standard Error|Least Squares Mean
133766|NCT00526097|Secondary|Number of CSBMs at Week 4|The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 4 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
133767|NCT00526097|Secondary|Number of CSBMs at Week 3|The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 3 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
133768|NCT00526097|Secondary|Number of CSBMs at Week 2|The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 2 in treatment period|Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
133769|NCT00526097|Secondary|Number of CSBMs at Week 1|The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer.|Week 1 in treatment period|Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure||CSBMs per week||Standard Error|Least Squares Mean
133770|NCT00526097|Primary|Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period|"A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool.~The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data."|4 Weeks|Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure||CSBMs per week||Standard Error|Least Squares Mean
133771|NCT00526058|Secondary|Device Parameters|"Apheresis Machine Physical parameters; Parameter Description (Abbreviation) Plasmat® Secura Plasma Flow (Plasma Pump) Plasma Pressure 1 (PLP 1) Plasma Pressure 2 (PLP 2) Filtration Pressure 1 (FP 1) Transmembrane Pressure (TMP) Plasmat® Futura Plasma Flow (Plasma Pump) Pressure at Precipitate Filter (PPF) Pressure at Dialysis Filter (PDF) Pressure Drop Across Precipitate Adsorber (PDPA)*~PDPA = PPF - PDF"|Analyzed at specific time points throughout the study from week 0 to week 24.||||||
133772|NCT00526058|Primary|Percent Change of the Pre and Post Treatment Value|The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.|Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.|||percentage of change||Standard Deviation|Mean
133773|NCT00526058|Secondary|Clinical Lab Profiles|Blood samples will be obtained for hematology; coagulation, Prothrombin time, , and Inflammatory markers,chemistry (Alkaline phosphatase, blood urea nitrogen, CPK (Creatine phosphokinase, Creatinine, Ferritin, Glucose, Lactate dehydrogenase, Phosphate, and uric acid) and liver functions (Total Protein, Total bilirubin, Alanine Aminotransferase (ALT), Aspartate transaminase (AST); immunoglobulins; complement components; endocrine; and urinalysis (color, specific gravity, wbc (white blood count), rbc (red blood count), urinary dipstick chemistry, and examination of sediment) will be obtained.|Analyzed at specific time points throughout the study from week 0 to week 24.||||||
133774|NCT00526058|Primary|Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.||Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..||||||
133775|NCT00525876|Primary|Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)|Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.|100 days post transplant|Analysis was per protocol.||participants|||Number
133776|NCT00525837|Secondary|Tolerability of Varenicline Measured by Adverse Symptoms Checklist (SAFTEE-SI LCN Modified)||6-8 weeks||||||
133777|NCT00525837|Secondary|Improvement on Patient and Clinician Clinical Global Impression Rating Scale (CGI)||6-8 weeks||||||
133778|NCT00525837|Secondary|Improvement on Snaith-Hamilton Anhedonia Scale||6-8 weeks||||||
133779|NCT00525837|Primary|Change in Quick Inventory of Depressive Symptoms, 16 Question Self-report|"this is a 16-item self report questionnaire that measures depressive symptoms.~Improvement is reported in change in depressive score~score ranges from 0-27, with higher numbers indicating more severe symptom reporting.~change is calculated by baseline plus/minus the value at the later time point"|Baseline and every 2 weeks until 8 weeks or study endpoint|||Units on a scale||95% Confidence Interval|Mean
133780|NCT00525824|Secondary|Percent Change in LDL-C After 6 Weeks Monotherapy|Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133781|NCT00525824|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment|Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Full Range|Mean
133786|NCT00525824|Secondary|Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment|Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133787|NCT00525824|Secondary|Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment|Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133788|NCT00525824|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment|Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133789|NCT00525824|Secondary|Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment|Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133790|NCT00525824|Secondary|Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment|Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133791|NCT00525824|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment|Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133792|NCT00525824|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment|Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100|Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)|||Percentage||Standard Deviation|Mean
133793|NCT00525798|Secondary|Number of Patients With Non-vertebral Fractures|"The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.~Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist’s report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained."|From baseline to month 36|all randomized patients||Participants|||Number
133794|NCT00525798|Primary|Number of Patients With New Vertebral Fractures|"The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).~The outcome is the number of new vertebral fractures from baseline to 36 months."|From baseline to month 36|all patients randomized who received at least one dose of study drug, with the addition of evaluable baseline spine X-ray and at least one follow-up for calculation of vertebral fractures.||Participants|||Number
133795|NCT00525733|Primary|The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.||48 weeks|||# subjects without detectable viremia|||Number
133796|NCT00525603|Primary|Overall Participant Response|Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Evaluated after 3 courses of 4 week therapy (12 weeks)|Sixty participants were analyzed for response. Four participants did not have a response and one participant was not evaluable.||Participants|||Number
133797|NCT00525525|Primary|Unexpected Toxicities During First 2 Cycles of Study Drug|Unexpected severe study-related adverse events|Within 8 weeks of initiating study therapy|||Events|||Number
133798|NCT00525525|Secondary|Progression-free Survival|Progression-free survival was defined from the date of diagnosis to the date that progressive disease was first observed on imaging, or the date at which nonreversible neurologic progression or permanently increased corticosteroid requirement, death from any cause, or early discontinuation of treatment. Imaging guidelines were used to evaluate progression: (i) 25% increase in the sum of products of all measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline; (ii) clear worsening of any assessable disease; (iii) appearance of any new lesion/site; and (iv) clear clinical worsening or failure to return for evaluation as a result of death or deteriorating condition (unless clearly unrelated to this cancer).|Approximately 6 months to 1 year|||months||95% Confidence Interval|Median
133799|NCT00525525|Primary|Overall Survival (OS)|Overall survival was defined from the date of diagnosis to date of death from any cause|Approximately 6-24 months|||months||95% Confidence Interval|Median
133800|NCT00525512|Secondary|Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status|Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|From first drug administration until 30 days after last drug administration|||participants|||Number
133801|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
133802|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
133803|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
133804|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 100 weeks|||units on scale||Standard Error|Least Squares Mean
133805|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 100 weeks|||liters||Standard Error|Least Squares Mean
133806|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 100 weeks|||liters||Standard Error|Least Squares Mean
133807|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 100 weeks|||seconds||95% Confidence Interval|Least Squares Mean
133808|NCT00525512|Secondary|Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase|COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.|baseline, 96 weeks|||participants|||Number
133809|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
133810|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
133811|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
133812|NCT00525512|Secondary|Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase|Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
133813|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks|||units on scale||Standard Error|Mean
133814|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks|||units on scale||Standard Error|Mean
133815|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks|||units on scale||Standard Error|Mean
133816|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks|||units on scale||Standard Error|Mean
133817|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks|||units on scale||Standard Error|Mean
133818|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks|||units on scale||Standard Error|Mean
133819|NCT00525512|Secondary|Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks|||units on scale||Standard Error|Mean
133820|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 96 weeks|||units on scale||Standard Error|Mean
133821|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 80 weeks|||units on scale||Standard Error|Mean
133822|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 64 weeks|||units on scale||Standard Error|Mean
133823|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 48 weeks|||units on scale||Standard Error|Mean
133824|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 32 weeks|||units on scale||Standard Error|Mean
133825|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 16 weeks|||units on scale||Standard Error|Mean
133826|NCT00525512|Secondary|Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase|The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)|baseline, 8 weeks|||unit on scale||Standard Error|Mean
133827|NCT00525512|Secondary|Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks|||unit on scale||Standard Error|Least Squares Mean
133828|NCT00525512|Secondary|Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks|||unit on scale||Standard Error|Least Squares Mean
133829|NCT00525512|Secondary|Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase|Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)|baseline, 96 weeks|||units on scale||Standard Error|Least Squares Mean
133830|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
133831|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
133832|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
133833|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
133834|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
133835|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
133836|NCT00525512|Secondary|Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
133837|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
133838|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
133839|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
133840|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
133841|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
133842|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
133843|NCT00525512|Secondary|Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase|FVC is the volume of air that can be forcibly blown out after full inspiration.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
133844|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
133845|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
133846|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
133847|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 48 weeks|||liters||Standard Error|Least Squares Mean
133848|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 32 weeks|||liters||Standard Error|Least Squares Mean
133849|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 16 weeks|||liters||Standard Error|Least Squares Mean
133850|NCT00525512|Secondary|Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 8 weeks|||liters||Standard Error|Least Squares Mean
133851|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 96 weeks|||liters||Standard Error|Least Squares Mean
133852|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 80 weeks|||liters||Standard Error|Least Squares Mean
133853|NCT00525512|Secondary|Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase|FEV1 is the maximal amount of air you can forcefully exhale in one second.|baseline, 64 weeks|||liters||Standard Error|Least Squares Mean
133862|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 16 weeks|||seconds||95% Confidence Interval|Least Squares Mean
133863|NCT00525512|Secondary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 8 weeks|||seconds||95% Confidence Interval|Least Squares Mean
133864|NCT00525512|Primary|90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase|Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.|baseline, 96 weeks|Full Analysis Set (FAS) includes all treated participants with a baseline and any post-dosing exercise duration data||seconds||95% Confidence Interval|Least Squares Mean
133865|NCT00525499|Secondary|Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12|"The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne:~0 No acne lesions.~Rare non-inflammatory lesions.~Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions.~Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion.~Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions.~Highly inflammatory lesions, multiple nodulo-cystic lesions."|Baseline to Week 12|ITT population: All randomized subjects||Participants|||Number
133866|NCT00525499|Primary|Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12|Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.|Baseline to Week 12|ITT population: All randomized subjects||Percent change||Standard Deviation|Mean
133867|NCT00525421|Secondary|Change in Serum C-reactive Protein and Serum Interleukin-6 Levels|Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).|2 weeks|||Percent change||Inter-Quartile Range|Median
133868|NCT00525421|Primary|Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)|Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 where 0=none, 1=>0-0.25 cm^2, 2= >0.25-1 cm^2, 3=>=1cm^2): right (R) and left (L) buccal mucosa, labial mucosa (upper and lower), lateral tongue (R and L), dorsum of tongue (R and L), ventral tongue and floor of mouth (R and L), maxillary gingiva (R and L), mandibular gingiva (R and L), and soft and hard palate. Total score for clinical signs (MOMI) is the sum of scores for 16 sites; separate scores for erythema and ulceration are the sums of respective scores.|2 weeks|||percent change||Inter-Quartile Range|Median
133869|NCT00525265|Primary|Body Weight|The body weight change from baseline at the time of final trial drug administration|Baseline, at the time of final trial drug administration|||Kg||Standard Deviation|Mean
133870|NCT00525174|Secondary|Social Stigma From Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|24 weeks|||Units on a scale||Standard Deviation|Mean
133871|NCT00525174|Secondary|Social Stigma From Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (2 of these questions pertain to social stigma of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 2 questions were summed and averaged for each individual (total sums could range from 0 to 10). A mean across all individuals was computed.|6 weeks|||Units on a scale||Standard Deviation|Mean
133872|NCT00525174|Secondary|Compliance With Treatment at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|24 weeks|||Units on a scale||Standard Deviation|Mean
133873|NCT00525174|Secondary|Compliance With Treatment at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (7 of these questions pertain to compliance of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 7 questions were summed and averaged for each individual (total sums could range from 0 to 35). A mean across all individuals was computed.|6 weeks|||Units on a scale||Standard Deviation|Mean
133874|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|24 weeks|||Units on a scale||Standard Deviation|Mean
133920|NCT00524680|Secondary|Pattern of Response of Parathormone|Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients||pg/mL||Standard Deviation|Mean
133875|NCT00525174|Secondary|Adverse Effects of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family (8 of these questions pertain to adverse effects of treatment). Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores for these 8 questions were summed and averaged for each individual (total sums could range from 0 to 40). A mean across all individuals was computed.|6 weeks|||Units on a scale||Standard Deviation|Mean
133876|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 24 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|24 weeks|||Units on a scale||Standard Deviation|Mean
133877|NCT00525174|Secondary|Impact of Treatment on Patient and Family at 6 Weeks|The Parental Amblyopia Treatment Index consists of 18 likert-type questions evaluating the impact of treatment on the patient and family. Questions are answered on a scale from 'Strongly Disagree' to 'Strongly Agree.' For analysis, values were coded numerically with integers from 5 (strongly agree) to 1 (strongly disagree) (0 was assigned to 'non-applicable' answers). The scores were summed and averaged for each individual (total sums could range from 0 to 90; means could range from 0 to 5). A mean across all individuals was computed from the individual means.|6 weeks|||Units on a scale||Standard Deviation|Mean
133878|NCT00525174|Secondary|Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||logMAR line||Standard Deviation|Mean
133879|NCT00525174|Secondary|Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||participants|||Number
133880|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks|||participants|||Number
133881|NCT00525174|Secondary|Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc. It is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best). If two shapes are identified correctly the patient moves to the next lower level. A failed test occurs when the patient cannot identify any shapes. A change of 1 level is a movement of 1 step in the scale (decrease shows improvement - ex. 100 to 60 is 1 level improved).|Baseline to 24 weeks|||participants|||Number
133882|NCT00525174|Secondary|Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||logMAR line||Standard Deviation|Mean
133883|NCT00525174|Secondary|Distribution of Patient Characteristics at the 24-week Outcome Exam.|The distribution of the number of participants in each patient characteristic category at the 24-week outcome examination was found (for example, the number of participants at 24 weeks who were 3 to <5 years old at the time of enrollment).|24 weeks|||participants|||Number
133884|NCT00525174|Secondary|Distribution of Subjects With 3 or More Lines of Improvement|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||participants|||Number
133898|NCT00525148|Secondary|Overall Survival Time|Overall survival time (OS) was also evaluated and was defined as the duration of time from start of treatment to time of death up to 93 months, regardless of the cause of death. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood’s standard error estimate.|Start of treatment to time to all death, up to 93 months|Treated set||Months||95% Confidence Interval|Median
133885|NCT00525174|Secondary|Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks|||participants|||Number
133886|NCT00525174|Secondary|Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks|||participants|||Number
133887|NCT00525174|Secondary|Mean Interocular Difference at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). A positive interocular difference indicates worse acuity in the amblyopic eye (one logMAR line = 5 letters or one Snellen line).|24 weeks|||logMAR line||Standard Deviation|Mean
133888|NCT00525174|Primary|Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). Change from baseline to 24 weeks was calculated. A positive difference indicates improvement (one logMAR line = 5 letters or one Snellen line).|Baseline to 24 weeks|||logMAR line||Standard Deviation|Mean
133889|NCT00525174|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) testing protocol resulting in a Snellen acuity score for 3 to <7 year olds; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds, resulting in a letter score that could range from 0 to 97 letters (0 worst; 97 best). Scores were converted to log of minimum angle of resolution (logMAR)(lower logMAR indicates better score). 'Worse' indicates acuity at 24 weeks is worse than acuity at baseline; 'Better' indicates acuity at 24 weeks is better than acuity at baseline.|Baseline to 24 weeks|||participants|||Number
133890|NCT00525174|Primary|Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks|||logMAR||Standard Deviation|Mean
133891|NCT00525174|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|24 weeks|||participants|||Number
133892|NCT00525161|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.|24 weeks|||percentage of participants||95% Confidence Interval|Number
133893|NCT00525161|Secondary|Time to Progression||continuously|||months||95% Confidence Interval|Median
133894|NCT00525161|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.|12 weeks after treatment & 8 weeks after initial documentation of response|one discontinued treatment after 2 weeks owing to a grade 3 rash and was not evaluable for response||participants|||Number
133895|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Intensity and Incidence of Worst Adverse Events Graded According to NCI CTCAE Version 3.0|Safety of afatinib as indicated by intensity and incidence of worst adverse events graded according to National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) Version 3.0 (R04-0474).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set||Percentage of participants|||Number
133896|NCT00525148|Secondary|Safety of BIBW 2992 as Indicated by Incidence of Specified Adverse Events.|Safety of afatinib as indicated by incidence of specified adverse events: skin reactions (a preferred term of the system organ class: Skin and subcutaneous tissue disorders) and gastrointestinal (GI) (a system organ class).|First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.|Treated set||Percentage of participants|||Number
133897|NCT00525148|Secondary|Cpre,ss,29|Predose concentration of the analyte in plasma at steady state immediately before administration of the 29th dose (Cpre,ss,29).|-0:05h (pre-dose) on Day 29|Treated Set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
133899|NCT00525148|Secondary|Progression-free Survival|Progression-free survival (PFS) as per independent review was defined as the duration of time from the start of treatment until the day of objective tumor progression was confirmed by tumor imaging (Progressive Disease according to RECIST 1.0) or death, whichever came first. Patients with unknown progression status or unknown date of progression were reviewed on a case-by-case basis. Patients known to be alive without progression at the end of the trial or the last follow-up visit were censored at the date of the last imaging when the patient was known to be alive and progression-free. Medians are calculated from the Kaplan-Meier estimates and 95% confidence intervals, using Greenwood’s standard error estimate.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set||Months||95% Confidence Interval|Median
133900|NCT00525148|Secondary|Time to Objective Response|"Time to objective response was defined as the number of days from the start of treatment to the first recorded objective response. Patients who did not experience objective response during the study were censored at the time of treatment discontinuation.~The results are provided as the percentage of participants for this Outcome Measure."|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set||Percentage of participants|||Number
133901|NCT00525148|Secondary|Duration of Objective Response|Duration of objective response (OR) was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death (or date of censoring for PFS) was objectively documented as per independent review.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set including only patients with objective response.||Weeks||Standard Deviation|Mean
133902|NCT00525148|Secondary|Duration of Clinical Benefit|Duration of clinical benefit (disease control) as per independent review was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence of SD, PR or CR.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated Set||weeks||Standard Deviation|Mean
133903|NCT00525148|Secondary|Clinical Benefit as Determined by RECIST 1.0|Clinical benefit was evaluated according to RECIST 1.0 by independent review assessment. Patients whose best RECIST 1.0 assessment was stable disease (SD), partial response (PR), or complete response (CR) were considered to have derived a clinical benefit from treatment.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set||Percentage of participants||95% Confidence Interval|Number
133904|NCT00525148|Primary|Objective Response (OR) as Determined by RECIST 1.0|Objective response (OR) was assessed for all treated patients by independent review as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. OR included complete response (CR) and partial response (PR), where CR or PR must have been confirmed by a subsequent response in ≥28 days.|Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.|Treated set: The patients who had taken at least one dose of afatinib were included in the treated set.||percentage of participants||95% Confidence Interval|Number
133905|NCT00525135|Secondary|Survival||up to 10 years post-study treatment|Due to early termination, participants were not followed for survival after the primary outcome timeframe|||||
133906|NCT00525135|Primary|Decrease in Tumor Size|Number of participants with decreased tumor size after study treatment|Baseline, 16 weeks|||participants|||Number
133907|NCT00525135|Secondary|Side Effects of Drugs Affecting Quality of Life|Number of participants experiencing > Grade 1 adverse events (including fatigue) attributable to study treatment|17 weeks|||participants|||Number
133908|NCT00525135|Secondary|Increased Radioactive Iodine Uptake|Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy|Baseline, 10 weeks|||participants|||Number
133909|NCT00525135|Primary|Decrease in Thyroglobulin Level|Number of participants with decreased thyroglobulin level after study treatment|Baseline, 16 weeks|||participants|||Number
133910|NCT00524940|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.|GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.|21 days post-vaccination|The GMT were evaluated in the per-protocol Population||Titer||95% Confidence Interval|Geometric Mean
133911|NCT00524940|Primary|Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.|Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.|0-3 days post-vaccination and entire study duration|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat Population.||Participants|||Number
133912|NCT00524771|Primary|Number of Participants With Arterial Thromboembolism (ATE)|Arterial Thromboembolism (ATE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months|||participants|||Number
133913|NCT00524771|Primary|Number of Participants With Venous Thromboembolism (VTE)|Venous thromboembolism (VTE) associated with the use of hormonal contraceptives that contain both an estrogen and progestin.|Time to event analysis within 48 months|Study participants that were not excluded due to protocol violations.||participants|||Number
133914|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
133915|NCT00524745|Secondary|Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
133916|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
133917|NCT00524745|Primary|Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.||25 months|||GMT ratio||95% Confidence Interval|Number
133918|NCT00524680|Secondary|Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls|Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls|Baseline, at 1, 3 ,6 months|All treated and eligible patients||participants|||Number
133921|NCT00524680|Primary|Pattern of Response of Serum 25(OH) D3 Levels|Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.|Baseline, at 1, 3, 6 months|All treated and eligible patients||ng/mL||Standard Deviation|Mean
133922|NCT00524589|Secondary|Expression of VDR and CYP24 in Peripheral Blood Mononuclear Cells as Assessed at Baseline and on Days 2 and 3||1 year||||||
133923|NCT00524589|Primary|Objective Response (Complete or Partial Response)||1 year|All treated and eligible patients||percentage of participants|||Number
133924|NCT00524576|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. This table describes SAEs reported by all subjects including those enrolled in the Australian center.||participants|||Number
133925|NCT00524576|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period (Day 0-30) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
133926|NCT00524576|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
133927|NCT00524576|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day follow-up period (Day 0-3) after the challenge dose|Analysis was performed on the Total Vaccinated Cohort. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
133928|NCT00524576|Secondary|Concentration of Anti-HBs Antibodies|Concentrations given as geometric mean concentration (GMC) and expressed in mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.||mIU/mL||95% Confidence Interval|Geometric Mean
133929|NCT00524576|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL.|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
133930|NCT00524576|Primary|Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|"Immune response defined as:~For initially seronegative subjects (anti-HBs antibody concentration <3.3 milli-international unit per milliliter [mIU/mL] before vaccination) antibody concentration ≥ 10mIU/mL at post booster.~For initially seropositive subjects: antibody concentration at post booster ≥ 4-fold the pre-vaccination antibody concentration."|30 days post-challenge dose|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data from the Australian center were not included following data quality issues detected at the investigator site.||participants|||Number
133931|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Total Days In Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean total days in hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital at given timepoint."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital."||total days in hospital||Standard Deviation|Mean
133932|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Admissions to Hospital Due to CD at Each Study Visit|"The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of admissions to hospital in the past 3 months is presented at each timepoint. N=number of participants with data for total days in hospital and at least one admission to hospital at given timepoint.."|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|"All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with data for total days in hospital and at least one admission to hospital."||number of admissions to hospital||Standard Deviation|Mean
133933|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Emergency Room Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to CD in the past 3 months. The mean number of visits at emergency room in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at emergency room.||number of visits at emergency room||Standard Deviation|Mean
133934|NCT00524537|Secondary|Healthcare Resource Utilization (HCRU): Mean Number Of Visits At Physician's Office Due to CD at Each Study Visit|The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations for their CD in the past 3 months. The mean number of visits at physician's office in the past 3 months is presented at each timepoint. N=number of participants with at least one visit at given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with at least 1 visit at physician's office.||number of visits at physician's office||Standard Deviation|Mean
135021|NCT00517075|Secondary|Cognitive Function||At baseline, the first and last rTMS sessions of each study phase (random and open), and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
133935|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Activity Impairment Due to Crohn’s Disease From Baseline to Each Visit|Activity impairment due to CD (the extent to which CD affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of activity impairment||Standard Deviation|Mean
133936|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Overall Work Impairment Due to Crohn’s Disease From Baseline to Each Visit|The mean percentage of overall work impairment due to CD (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which CD decreased productivity (%)* [number of hours worked / (number of hours of work missed due to CD + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of overall work impairment||Standard Deviation|Mean
133937|NCT00524537|Secondary|WPAI:SHP: Change in Mean Percentage of Impairment While Working (Presenteeism) Due to Crohn’s Disease From Baseline to Each Visit|Presenteeism (the extent to which CD decreased productivity) is presented as the mean percentage of impairment while working due to CD, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of impairment while working||Standard Deviation|Mean
133938|NCT00524537|Secondary|Work Productivity and Activity Impairment: Special Health Problem (WPAI:SHP): Change in Mean Percentage of Work Time Missed (Absenteeism) From Baseline to Each Visit|Absenteeism, presented as the mean percentage of work time missed due to Crohn's Disease (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with WPAI:SHP measurements.||percentage of work time missed||Standard Deviation|Mean
133939|NCT00524537|Secondary|Physician's Global Assessment of Disease Activity (PGA): Change From Baseline to Each Visit|The PGA measures the physician's assessment of the patient's current disease activity from using 6 assessments (general well-being, abdominal pain, diarrhea, blood in stool, abdominal mass, and Crohn's disease-related complications). The PGA score is the sum of the subscores and ranges from 0 (very good) to approximately 25 (very bad). A negative change in score indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with PGA measurements.||units on a scale||Standard Deviation|Mean
133940|NCT00524537|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score: Change From Baseline to Each Visit|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and range from 10 (poor QoL) to 70 (good QoL). A higher score indicates a better HRQoL; a positive change from baseline indicates improvement. N=the number of participants with available data at both baseline and given timepoint.|Baseline (Enrollment) and 12, 24, 36, 48, 60, and 72 Months|All participants in the All Treated Population (received at least 1 injection of Humira in the registry) with SIBDQ measurements.||units on a scale||Standard Deviation|Mean
133941|NCT00524537|Primary|Number of Participants With Registry Treatment-Emergent Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Registry treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of Humira in the registry. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~For more details on adverse events please see the AE section below."|Registry treatment-emergent SAEs and AEs of special interest are summarized from the day of the first dose of Humira in the registry until 70 days after the last non-missing Humira injection date in the registry (up to approximately 6 years).|All Treated Population: All participants who received at least 1 injection of Humira in the registry||Participants|||Count of Participants
133942|NCT00524511|Secondary|Patient Satisfaction of Cosmesis of Surgical Wound|survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)|before hospital discharge after surgery|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.|||||
133943|NCT00524511|Primary|Wound Complication Rate|Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound|within six weeks of study intervention|No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.|||||
133944|NCT00524459|Secondary|Safety, in Terms of Neutropenia and Cardiac Toxicity||Every cycle during study treatment and 8 weeks post-treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133945|NCT00524459|Secondary|Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy||Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133946|NCT00524459|Secondary|Overall Clinical Local Regional Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133947|NCT00524459|Primary|Clinical Complete Response||Surgery done after completion of six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133948|NCT00524459|Primary|Pathological Complete Response||Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133949|NCT00524420|Secondary|Adverse Events|Adverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit.|Measured daily|||number of adverse events|||Number
133950|NCT00524420|Secondary|Hamilton Depression Rating Scale|The research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal.|Measured weekly|||units on a scale||Standard Deviation|Mean
133951|NCT00524420|Secondary|Gracely Box Unpleasantness Scale|The BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS.|Measured weekly|||units on a scale||Standard Deviation|Mean
133952|NCT00524420|Primary|Gracely Box Intensity Rating Scale|The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.|Measured weekly|||units on a scale||Standard Deviation|Mean
133953|NCT00524394|Primary|Cytokines|IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .|O TO 30 DAYS OF LIFE|zero participant analyzed|||||
133954|NCT00524394|Primary|Immunological Homeostasis|"Describe changes in immunological homeostasis that indicate the normal function vs. presence of sepsis in newborn infants of various gestational ages"|0 to 30 days of life.||||||
133955|NCT00524368|Secondary|Number of Participants Developing Mutations at Endpoint|Development of Mutations in Virologic Failures (Plasma Viral Load less than 50 Copies/mL) at endpoint.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||Participants|||Number
133956|NCT00524368|Secondary|Predose Plasma Concentration (C0h) of DRV and Rtv.|Pharmacokinetic parameter C0h was assessed. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||ng/mL||Full Range|Median
133957|NCT00524368|Secondary|Area Under the Curve From the Time of Study Medication Administration Upto 24 Hour Postdose (AUC24h) of DRV and Rtv|Pharmacokinetic parameter AUC24h was assessed from the time of study medication administration upto 24 hour postdose. Population Pharmacokinetic Estimates of DRV and rtv were evaluated.|0 hour predose and 1 hour post dose measured at Weeks 4 and 24. Any time point measured at Weeks 8 and 48.|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||ng*h/mL||Full Range|Median
133958|NCT00524368|Secondary|Percentage of Participants Adherent/Non-adherent to ARV as Determined by Modified Medication Adherence Self Report Inventory (M-MASRI) Questionnaire at Week 48|Self-reported adherence to the ARV medications was measured. The M-MASRI asks participants to report the number of doses taken, as well as the number of doses taken during the last 30 days prior to the study visit by means of a horizontal visual analogue scale (VAS) that generates a self-rated percentage of doses of all the ARV medications taken during the past 30 days.|48 weeks|Intent-to-Treat (ITT) population: Participants who were randomized and who received at least 1 dose of study medication.||Percentage of participants|||Number
133959|NCT00524368|Secondary|Change From Baseline in Total Functional Assessment of HIV Infection (FAHI) Score|The FAHI is a 44-item questionnaire and incorporates 5 functional scales (physical well-being, emotional well-being/living with HIV, functional and global well-being, social well-being, and cognitive functioning). Each scale included several questions (all 5 scales include total 44 questions). For each question, participants gave a score of either 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit) and 4 (very much). Total FAHI imputed score is calculated by adding scores for each question. The range of total FAHI score is 0 to 176. Higher scores indicate worsening.|48 weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.||Scores on a scale||Full Range|Median
133960|NCT00524368|Secondary|Change in CD4+ Cell Count From Baseline|CD4+ cell count was calculated using the Last Observation Carried Forward (LOCF) algorithm.|48 Weeks|Intention To Treat (ITT) population - last observation carried forward (LOCF): Intermittent missing values and missing values due to premature discontinuation were imputed with the last observation.||10e6/l||Full Range|Median
133961|NCT00524368|Secondary|Time-averaged Difference (DAVG) of log10 Plasma Viral Load Over 48 Weeks||48 weeks|Intention To Treat (ITT) population: Observed cases||log10 copies/mL||Standard Error|Least Squares Mean
133962|NCT00524368|Secondary|Time to Loss of Virologic Response|Time taken to lose the virologic response ie, plasma viral load less than 50 copies/mL by participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Days||Standard Error|Mean
133963|NCT00524368|Secondary|Time to Reach First Virologic Response|Time (in weeks) to achieve viral load less than 50 copies/mL by the participants.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Days||Full Range|Median
133964|NCT00524368|Secondary|Change in log10 Viral Load From Baseline at Week 48||48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||log10 copies/mL||Full Range|Median
133965|NCT00524368|Secondary|Virologic Response at Week 48 (Viral Load Less Than 400 Copies/mL)|Number of participants with confirmed plasma viral load less than 400 copies/mL at Week 48.|48 weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Participants|||Number
133966|NCT00524368|Primary|Virological Response at Week 48 (Number of Participants With Plasma Viral Load Less Than 50 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|48 Weeks|Intention To Treat (ITT) population: Participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if preceeding and succeeding visits indicated response. Otherwise, intermittent values were imputed with nonresponse.||Participants|||Number
133967|NCT00524342|Secondary|A Secondary Outcome Measure is the Frequency of IL-11 Associated Adverse Events.||The time frame is up to 7 months per subject.|||participants|||Number
133968|NCT00524342|Secondary|A Secondary Outcome Measure is the Mechanism of IL-11 Effect by VWF mRNA.||The time frame is up to 7 months per subject.||||||
133969|NCT00524342|Primary|>50% Reduction in PBAC at 6 Months|Subjective estimate of blood loss was measured by using a Pictorial blood assessment chart (PBAC) . The PBAC measures scores on a scale where 0 to 100 is normal and greater than 100-200 are abnormal.|6 months|||percentage of participants|||Number
133970|NCT00524316|Secondary|Tumor Marker Response (AFP)||Baseline, week 7 and every 6 weeks after|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133971|NCT00524316|Secondary|Quality of Life as Measured by the FACT-HEP Scale Prior to Each Course of Therapy||Every 6 weeks|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133972|NCT00524316|Secondary|Safety and Tolerability|"Number of participants with adverse advent.~Please refer to adverse event reporting for more detail."|Daily while on treatment|All treated and eligible patients||participants|||Number
133973|NCT00524316|Secondary|Tissue Perfusion, Ktrans, IAUC, and Percent Viable Tumor as Measured by DCE-MRI at Baseline and on Days 8 (Before Transarterial Chemoembolization), 10, and 35||Baseline, day 8, day 10, day 28 and day 35|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133974|NCT00524316|Secondary|Overall Survival|median survival in months|Every 6 months after removal from treatment till death|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133975|NCT00524316|Primary|Progression-free Survival at 4 Months||4 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
133976|NCT00524303|Other Pre-specified|Transcriptional Profiling of Total RNA and the Correlation to Response/Non-response to Treatment|Transcriptional data were of poor quality and thus could not be analyzed. Gene pathways that correlate with response/non-response to treatment were to have been evaluated. The unit of measure is unit less; however, the processed values would be considered normalized relative expression level.|Tumor core biopsy taken at Baseline and Treatment Day 14||||||
133977|NCT00524303|Other Pre-specified|Cancer Stem Cells and the Correlation to Response/Non-response to Treatment|Stem cell data were of poor quality and thus could not be analyzed. Increases or decreases in cancer stem cells and how the changes correlated with response/non-response to treatment were to have been assessed.|Tumor core biopsy taken at Baseline and Treatment Day 14||||||
133993|NCT00524134|Secondary|Prevalence of Seizure Freedom||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
135022|NCT00517075|Secondary|Smoking Behaviors||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
133978|NCT00524303|Other Pre-specified|Mean Intra-tumoral Expression of the Indicated Proteins at Baseline and Day 14|Expression (exp) of biomarker proteins (prot) were analyzed to determine if individual prot levels either in the Baseline or Day 14 breast tumor biopsy specimen correlated with breast pCR. A biomarker indicates a change in exp or state of a prot that correlates with the risk or disease progression, or with the susceptibility of the disease to a given treatment. Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like blood or tissue. pCR=yes: participants (par.) had breast pCR. pCR=no: par. did not have breast pCR. Prot exp values are represented as normalized, scaled values; the unit of measurement is unit-less. Raw exp values were processed as follows: background subtraction of the raw exp value, then that value divided by beta-acting exp to normalize the exp value. A Standard Z score was calculated to scale the exp value.|Tumor core biopsy taken at Baseline and Treatment Day 14|ITT-E Population. Only those participants with matched pairs of biopsy samples for analysis at Baseline and on Day 14 were analyzed.||: normalized relative expression level||Standard Deviation|Mean
133979|NCT00524303|Secondary|Cumulative Number of Participants With at Least One Decrease of More Than or Equal to 20% in Left Ventricular Ejection Fraction (LVEF) at the Indicated Time Points Compared to LVEF at Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function. LVEF was measured by performing echocardiogram (ECHO). If ECHO could not be performed or if the investigator believed that it was not conclusive to evaluate LVEF, then a multigated acquisition (MUGA) scan was performed.|Weeks 3, 9, and 15; EOT or early withdrawal; and 3- and 6-month survival follow-up after last chemotherapy course|Safety Population. Not all participants in the Safety Population were analyzed: some participants were randomized to an arm they did not want or participants were randomized in error (eligibility criteria weren’t met).||participants|||Number
133980|NCT00524303|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Status at Baseline and at EOT or Early Withdrawal|12-lead ECGs were performed, and participants were classified as having normal ECG, abnormal- not clinically significant (NCS) ECG, and abnormal-clinically significant (CS) ECG per investigator opinion and reported result.|Baseline and EOT (up to Week 26) or Early withdrawal|Safety Population: all randomized participants (par) who received at least one dose of investigational product, based on actual treatment received if this differed from that to which par was randomized. Not all par were analyzed: some par were randomized to an arm they did not want or par were randomized in error (eligibility criteria weren’t met).||participants|||Number
133981|NCT00524303|Secondary|Percentage of Participants (Par.) With Disease-free Survival (DFS) at the End of 5 Years From Randomization|Percentage is the Kaplan Meier estimate of DFS. DFS is time from randomization until disease recurrence (contralateral breast cancer; second primary cancer; progression during neo-adjuvant treatment; or death from any cause). Par. who experienced progression during treatment and were withdrawn were considered to have a DFS event at withdrawal.|From first dose date until disease progression, assessed up to a maximum of 5 years|ITT Population||Percentage||95% Confidence Interval|Number
133982|NCT00524303|Secondary|Percentage of Participants With Clinical Complete Response (cCR) at 26 Weeks or at End of Treatment (EOT) or Early Withdrawal|cCR was defined as the percentage of participants achieving either a Complete Response (CR) or a Partial Response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Week 26 or EOT or Early withdrawal|ITT Population: all randomized participants regardless of whether they had received any treatment.||percentage of participants|||Number
133983|NCT00524303|Primary|Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy|A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.|Week 26|Intent-to-Treat-Evaluable (ITT-E) Population: ITT participants with evaluable tumor responses who had been >=75% compliant to 5-fluorouracil (5-FU) 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 (FEC75) and paclitaxel 80 mg/m^2 and had undergone surgery.||percentage of participants|||Number
133984|NCT00524264|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population||Percentage of patients with ≥ 3 lines|||Number
133985|NCT00524264|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population||millimeters squared (mm²)||Standard Deviation|Mean
133986|NCT00524264|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
133987|NCT00524264|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
133988|NCT00524225|Primary|Volume of Blood Transfusion|The volume of blood transfusion required (units of blood) after the surgical procedure.|4 weeks|||units of blood|||Number
133989|NCT00524225|Secondary|A Secondary Outcome Measure is the Frequency of IL-11 Associated Adverse Events.||The time frame is within 4 weeks of surgery.||||||
133990|NCT00524225|Secondary|A Secondary Outcome Measure is the Mechanism of IL-11 Effect by VWFmRNA.||4 weeks per subject||||||
133991|NCT00524225|Primary|Volume of Surgical Blood Loss|Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure.|4 weeks|||cc|||Number
133992|NCT00524134|Secondary|Prevalence of Medication Retention/Treatment Failure||16 weeks|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
135023|NCT00517075|Secondary|Theory of Mind||At baseline and the end of each study phase (random and open)|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
133994|NCT00524134|Secondary|Percent Change in Total Seizure Count Between Treatment Arms||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
133995|NCT00524134|Primary|Proportion of Each Treatment Arm With ≥50% Reduction in Seizures||12 weeks at highest tolerated dose|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in October 2009.|||||
133996|NCT00524121|Secondary|Response by EGFR Mutation Status||Radiologic evaluation every 3 months, up to 5 years|||participants|||Number
133997|NCT00524121|Secondary|Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression||Radiologic evaluation every 3 months, up to 5 years|||participants|||Number
133998|NCT00524121|Secondary|Response by Epidermal Growth Factor Receptor (EGFR) Expression||Radiologic evaluation every 3 months, up to 5 years|||participants|||Number
133999|NCT00524121|Secondary|Correlation of Smoking Status With Overall Survival||5 years|Patients Treated with Study Therapy||months||95% Confidence Interval|Median
134000|NCT00524121|Secondary|Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale|Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes|Baseline and Week 3|Patients Treated with Study Therapy and with FACT-E scores available||FACT-E Score||Full Range|Median
134001|NCT00524121|Secondary|Progresssion-Free Survival|Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 3 months, up to 5 years|||months||95% Confidence Interval|Median
134002|NCT00524121|Secondary|Complete Response|"Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation.~Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor."|4-8 weeks after completion of radiation.|Patients Treated with Study Therapy||percentage of participants||95% Confidence Interval|Number
134003|NCT00524121|Primary|Overall Survival||5 years|||months||95% Confidence Interval|Median
134004|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score|The MOS SF-36 is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
134005|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score|The Medical Outcomes Study Short Form Health Survey-36 (MOS SF-36) is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
134006|NCT00524043|Secondary|Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score|The Personal and Social Performance (PSP) scale assesses the degree of difficulty (ranging from i [absent] to vi [very severe]) a patient exhibits over a 1-month period in socially useful activities, personal and social relationships, self care, and disturbing and aggressive behavior. The overall score ranges from 1 to 100. Patients with scores of 71 to 100 have a mild degree of difficulty; patients with scores from 31 to 70 have various degrees of disability; and patients with scores of 30 or less function so poorly as to require intensive supervision.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
134007|NCT00524043|Secondary|Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S|The Clinical Global Impression-Severity (CGI-S) rating scale is used by psychiatrists to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). The scale permits a global evaluation of the patient's condition at a given time.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Full Range|Median
134022|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 4)|Change from baseline in number of steps per day (week 4)|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
135024|NCT00517075|Secondary|Depression||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
134008|NCT00524043|Primary|Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment).|The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.|Baseline, 6 weeks|The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.||units on a scale||Standard Deviation|Mean
134009|NCT00524030|Secondary|Pregabalin Exposure-Response Analysis|Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates.|Day 126|MITT Full Study Set||Percentage of Participants|||Number
134010|NCT00524030|Secondary|Pregabalin Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Baseline up to 20 weeks||||||
134011|NCT00524030|Secondary|Percentage of Seizure-Free Participants by Study Phase|Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140)|Day 1 up to Day 140|MITT Full Study Set||Percentage of Participants|||Number
134012|NCT00524030|Secondary|Mean Time on Pregabalin Monotherapy||Week 2 to Week 20|MITT Full Study Set; N=number of participants entering Monotherapy Period||Days||Standard Deviation|Mean
134013|NCT00524030|Secondary|Percentage of Participants Who Met Protocol-Specified Exit Events|Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity|Week 2 up to Week 18|MITT Efficacy Set||Percentage of Participants|||Number
134014|NCT00524030|Secondary|Percentage of Participants Completing 20 Weeks of Double-Blind Treatment||Randomization up to Week 20|MITT Full Study Set||Percentage of Participants|||Number
134015|NCT00524030|Secondary|Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100%|Week 2 up to Week 18|MITT Full Study Set: all randomized participants who met the MITT definition (received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2)||Percentage of Participants||95% Confidence Interval|Number
134016|NCT00524030|Primary|Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria|Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100%|Week 2 up to Week 18|Modified Intent to Treat (MITT) Efficacy Set: The first 125 participants randomized who received at least 1 dose of pregabalin in DB treatment phase, had BL seizure assessment, and participated in DB efficacy assessment after Week 2. Number of participants analyzed (N)= number of MITT participants with discontinuation/completion data.||Percentage of Participants||95% Confidence Interval|Number
134017|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 24)|Change from baseline in number of steps per day (week 24)|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
134018|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 20)|Change from baseline in number of steps per day (week 20)|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
134019|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 16)|Change from baseline in number of steps per day (week 16)|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
134020|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day (Week 12)|Change from baseline in Number of steps per day (week 12)|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
134021|NCT00523991|Secondary|Change From Baseline in Number of Steps Per Day(Week 8)|Change from baseline in number of steps per day (week 8)|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Error|Least Squares Mean
134023|NCT00523991|Secondary|Number of Steps Per Day (Baseline)|Number of steps per day (baseline)|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Steps||Standard Deviation|Mean
134024|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 24)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
134025|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 20)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
134026|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 16)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
134027|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 12)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
134028|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 8)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
134029|NCT00523991|Secondary|Change From Baseline in Active Energy Expenditure (Week 4)|The amount of energy (kcal/day) that a person uses while physically active.|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Error|Least Squares Mean
134030|NCT00523991|Secondary|Active Energy Expenditure (Baseline)|The amount of energy (kcal/day) that a person uses while physically active.|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||kilo calories per day||Standard Deviation|Mean
134031|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 24)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
134032|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 20)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
134033|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 16)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
134034|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 12)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
134035|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 8)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
134036|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Week 4)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
134037|NCT00523991|Secondary|Number of Participants With Healthy Lifestyle (Baseline)|Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||Participants|||Number
134097|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)|Change from baseline in forced vital capacity (week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134038|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134039|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134040|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134041|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134042|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134043|NCT00523991|Secondary|Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134044|NCT00523991|Secondary|Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Moderate or higher intensity is greater than or equal to three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Deviation|Mean
134045|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 24|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134098|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)|Change from baseline in forced vital capacity (week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134046|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 20|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134047|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 16|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134048|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity defined as less than three metabolic equivalents.~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 12|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134049|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 8|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134050|NCT00523991|Secondary|Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm"|baseline, week 4|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Error|Least Squares Mean
134051|NCT00523991|Secondary|Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day|"Light intensity is less than three metabolic equivalents.~Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject’s resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.~ln in measure value unit means natural logarithm."|baseline|Activity evaluable set population: All subjects included in the Full Analysis Set (FAS), who had physical activity and energy expenditure data available for >= 12 weeks, and who wore the activity monitor for >11 hours for at least 4 days||ln(minutes)||Standard Deviation|Mean
134052|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134053|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134099|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)|Change from baseline in forced vital capacity (week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134054|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134055|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134056|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134057|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134058|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
134059|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134060|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134100|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)|Change from baseline in forced vital capacity (week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134101|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)|Change from baseline in forced vital capacity (week 16, 30 minutes)|baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134061|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134062|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134063|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134064|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134065|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
134066|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134067|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134102|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)|Change from baseline in forced vital capacity (week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
135025|NCT00517075|Secondary|Social Functioning||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
134068|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134069|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134070|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134071|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134072|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
134073|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134074|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134103|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)|Change from baseline in forced vital capacity (week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134104|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)|Change from baseline in forced vital capacity (week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134075|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134076|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134077|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134078|NCT00523991|Secondary|Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)|WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Error|Least Squares Mean
134079|NCT00523991|Secondary|Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||units on a scale||Standard Deviation|Mean
134080|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
134081|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
134082|NCT00523991|Secondary|Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)|"The patient’s global assessment was based on the subject’s need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject’s ability to exercise and perform daily activities.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
134105|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)|Change from baseline in forced vital capacity (week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134083|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
134084|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
134085|NCT00523991|Secondary|Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)|"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.~Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||Participants|||Number
134086|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 24)|Difference in number of days that participants used albuterol prn per week between week 24 and baseline|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Error|Least Squares Mean
134087|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 20)|Difference in number of days that participants used albuterol prn per week between week 20 and baseline|baseline, week 20|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
134088|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 16)|Difference in number of days that participants used albuterol prn per week between week 16 and baseline|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
134089|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. -(Week 12)|Difference in number of days that participants used albuterol prn per week between week 12 and baseline|baseline, week 12|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
134090|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 8)|Difference in number of days that participants used albuterol prn per week between week 8 and baseline|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
134091|NCT00523991|Secondary|Change From Baseline in Albuterol Use p.r.n. - (Week 4)|Difference in number of days that participants used albuterol prn per week between week 4 and baseline|baseline, week 4|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
134092|NCT00523991|Secondary|Albuterol Use p.r.n. (Baseline)|Number of days that participants used albuterol prn per week|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||days||Standard Deviation|Mean
134093|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)|Change from baseline in forced vital capacity (week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134094|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)|Change from baseline in forced vital capacity (week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134095|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)|Change from baseline in forced vital capacity (week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134096|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)|Change from baseline in forced vital capacity (week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
135026|NCT00517075|Secondary|Global Clinical Improvement||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
134106|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)|Change from baseline in forced vital capacity (week 8, 30 minutes)|baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134107|NCT00523991|Secondary|Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)|Change from baseline in forced vital capacity (week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134108|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 180 Minutes)|Forced vital capacity (baseline, 180 minutes)|baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134109|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 120 Minutes)|Forced vital capacity (baseline, 120 minutes)|baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134110|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 60 Minutes)|Forced vital capacity (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134111|NCT00523991|Secondary|Forced Vital Capacity (Baseline, 30 Minutes)|Forced vital capacity (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134112|NCT00523991|Secondary|Forced Vital Capacity (Baseline, Pre-dose)|Forced vital capacity (baseline, pre-dose)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134113|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134114|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134115|NCT00523991|Secondary|Change From Baseline in Peak Forced Vital Capacity (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134116|NCT00523991|Secondary|Peak Forced Vital Capacity (FVC) (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134117|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 24)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134118|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 16)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134119|NCT00523991|Secondary|Change From Baseline in Trough Forced Vital Capacity (at Week 8)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134120|NCT00523991|Secondary|Trough Forced Vital Capacity (Baseline)|Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134121|NCT00523991|Secondary|FVC AUC0-3 at Week 24 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Error|Least Squares Mean
134122|NCT00523991|Secondary|FVC AUC0-3 at Week 16 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)|baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Deviation|Mean
134123|NCT00523991|Secondary|FVC AUC0-3 at Week 8 Minus Baseline|Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)|baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Deviation|Mean
134124|NCT00523991|Secondary|FVC AUC0-3 at Baseline|Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)|baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Deviation|Mean
134125|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)|baseline, week 24, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134126|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)|baseline, week 24, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134127|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)|baseline, week 24, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134128|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)|baseline, week 24, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134129|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)|Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)|baseline, week 24, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134130|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)|baseline, week 16, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134131|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)|baseline, week 16, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134132|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)|baseline, week 16, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134133|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)|Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)|Baseline, week 16, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134134|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)|baseline, week 16, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134135|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)|baseline, week 8, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134136|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)|baseline, week 8, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134137|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)|baseline, week 8, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134223|NCT00523341|Primary|Number of Participants With Laboratory Toxicities of Grade ≥ 3|Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.|84 months|All participants who received at least 1 dose of denosumab||participants|||Number
134138|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)|Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)|Baseline, week 8, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134139|NCT00523991|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)|Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)|baseline, week 8, pre-dose|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134140|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)|Forced expiratory volume in 1 second (baseline, 180 minutes)|Baseline, 180 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134141|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)|Forced expiratory volume in 1 second (baseline, 120 minutes)|Baseline, 120 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134142|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)|Forced expiratory volume in 1 second (baseline, 60 minutes)|baseline, 60 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134143|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)|Forced expiratory volume in 1 second (baseline, 30 minutes)|baseline, 30 minutes|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134144|NCT00523991|Secondary|Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)|Forced expiratory volume in 1 second (baseline, pre-dose)|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134145|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134146|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134147|NCT00523991|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134148|NCT00523991|Secondary|Peak Forced Expiratory Volume in 1 Second (Baseline)|Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134149|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Error|Least Squares Mean
134150|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 16|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134151|NCT00523991|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline, week 8|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134152|NCT00523991|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)|Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.|Baseline|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres||Standard Deviation|Mean
134153|NCT00523991|Primary|Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)|Change = Week 24 Value – Baseline Value|baseline, week 24|Full Analysis Set (FAS): All randomized subjects who received at least 1 dose of study drug, had baseline and at least 1 post baseline data measurement available for the primary endpoint||litres * hours||Standard Error|Least Squares Mean
134154|NCT00523978|Primary|Cryoablation Procedure Events (CPEs)|Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.|To end of ablation procedure|Data for subjects who were randomized to the Experimental group and received cryoablation therapy were included in this analysis. All CPEs reported in the Experimental group were included in the analysis regardless of their association with the first or a repeat cryoablation.||participants|||Number
134155|NCT00523978|Primary|Freedom From Major Atrial Fibrillation Events (MAFEs)|Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.|12 Months|mITT set included all subjects (82 CS, 163 ES) who were enrolled, randomized, and received treatment.||participants|||Number
134156|NCT00523978|Primary|Treatment Success|Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.|12 months|The mITT population consisted of all subjects, who were enrolled, randomized and received treatment||participants|||Number
134157|NCT00523978|Primary|Freedom From Chronic Treatment Failure (CTF)|Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|12 month follow up period|This section includes data for subjects who were randomized, received treatment and were followed through 12-Months post randomized treatment regardless of AF Drug usage. Subjects who experienced Acute Procedural Failure in the Experimental group were not included in this analysis of post-procedural failure causes.||participants|||Number
134158|NCT00523978|Primary|Acute Procedural Success (APS)|Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.|371.4 Minutes (Average)|Subjects evaluated were from the modified Intent to Treat subset (mITT)or subjects that were enrolled, randomized and received treatment.||participants|||Number
134159|NCT00523939|Secondary|Time to Neurologic Progression||2 years||||||
134160|NCT00523939|Primary|Response Rate|To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.|1 year|Primary outcome measure was not assessed due to early study termination.|||||
134161|NCT00523848|Secondary|Time to Disease Progression||Every 3 months|||months||95% Confidence Interval|Median
134162|NCT00523848|Secondary|Complete Response Rate||Every 3 months|Evaluable patients.||percentage of participants||95% Confidence Interval|Number
134163|NCT00523848|Primary|Overall Response Rate (Complete and Partial)||Every 3 months|Evaluable patients||percentage of participants||95% Confidence Interval|Number
134164|NCT00523809|Primary|Progression-free Survival (PFS)|Number or participants with no disease progression or death for any reason during first 100 days following transplantation. Participants followed every 3 months for first year.|100 days after transplant|Study objectives were not meet, analysis was not performed.|||||
134165|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.|Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||Percentage of participants|||Number
134166|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||Percentage of participants|||Number
134167|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||BPM (beats per minute)||95% Confidence Interval|Mean
134168|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||mmHg||95% Confidence Interval|Mean
134267|NCT00522418|Secondary|Changes in Anti-epileptic Drugs (AEDs)|Change from baseline in number of AED medications by visit|Change from baseline in number of AEDs at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for fifty-nine (59) patients.||Number of AEDs Taken||Full Range|Median
134169|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||mmHg||95% Confidence Interval|Mean
134170|NCT00523744|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of participants|||Number
134171|NCT00523744|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||Percentage of participants|||Number
134172|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)|Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.||mmHg||95% Confidence Interval|Mean
134173|NCT00523744|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||BPM (beats per minute)||95% Confidence Interval|Mean
134174|NCT00523744|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
134175|NCT00523744|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
134176|NCT00523744|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)|Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.||mmHg||95% Confidence Interval|Mean
134279|NCT00522392|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive. The OS results are based on data as of April 2014.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients||Months||95% Confidence Interval|Median
134177|NCT00523718|Secondary|Clinical Global Impression (CGI) - Severity of Illness Item|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|14 weeks|||units on a scale||Standard Deviation|Mean
134178|NCT00523718|Secondary|Average Hamilton Anxiety Inventory (HAM-A)|The Hamilton Anxiety Rating Scale (HARS or HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score ranges from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. A score of 31 or greater represents very severe anxiety severity.|14 weeks|||units on a scale||Standard Deviation|Mean
134179|NCT00523718|Secondary|Average Hamilton Depression Inventory (HAM-D)|"The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The HAM-D 17-item scale ranges from 0 (normal) to >23 (very severe depression), with a maximum score of 52. The 24-item scale has a maximum score of 75. Severity of depression (e.g. normal or very severe) is based upon the score in the first 17-items."|14 weeks|||units on a scale||Standard Deviation|Mean
134180|NCT00523718|Primary|Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|"The Yale–Brown Obsessive Compulsive Scale (Y-BOCS) is a test to rate the severity of obsessive–compulsive disorder (OCD) symptoms. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The results can be interpreted based on the total score:~0–7 is sub-clinical; 8–15 is mild; 16–23 is moderate; 24–31 is severe; 32–40 is extreme.~Improvement was defined apriori as a 25% improvement from baseline"|14 weeks|||participants|||Number
134181|NCT00523705|Secondary|Subject Satisfaction Questionnaire||Study endpoint|Not analyzed due to small number of subjects.|||||
134182|NCT00523705|Secondary|Patient Global Evaluation of Improvement (PGE)||Throughout treatment|Not analyzed due to small number of subjects|||||
134183|NCT00523705|Secondary|Sheehan Disability Scale (SDS)||Throughout study|Data not analyzed due to only 11 subjects.|||||
134184|NCT00523705|Primary|Subject Daily Symptom Rating Score.|A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408.|baseline and 5 months.|||units on a scale||Standard Deviation|Mean
134185|NCT00523640|Secondary|Overall Survival|Time from enrollment until death from any cause.|60 months|||months||95% Confidence Interval|Median
134186|NCT00523640|Primary|Progression-free Survival|Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline|60 months|||months||95% Confidence Interval|Median
134187|NCT00523640|Primary|Objective Response Rate|Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.|12 weeks|||proportion|||Number
134188|NCT00523614|Primary|Risk of Venous Thromboembolism (VTE) Between Women Who Use Dienogest/Ethinylestradiol (DNG/EE) and Women Who Use Other Low-dose Combined Oral Contraceptives (COC)|The time frame is the time when venous thromboembolism (VTE) was diagnosed in the cases group. VTE includes deep venous thrombosis and pulmonary embolism. These clinical endpoints were established by magnetic resonance imaging, spiral computer tomography, duplex sonography, and lung scintigraphy.|01/2002 - 01/2008|||Participants|||Number
134189|NCT00523549|Secondary|Change in Estimated Central Aortic Pressure|Change from baseline in estimated central aortic pressure at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat||mm Hg||Standard Deviation|Mean
134190|NCT00523549|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|Change from baseline in msDBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat population||mm Hg||Standard Deviation|Mean
134191|NCT00523549|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|Change from baseline in msSBP at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat||mm Hg||Standard Deviation|Mean
134192|NCT00523549|Secondary|Percent Change From Baseline in Vascular Stiffness|Percent change from baseline in Vascular Stiffness (measured by radial augmentation index [AI]) at Weeks 8 and 24|Baseline to 8 and 24 weeks after treatment|Intent-to-treat||percentage of change in mean AI||Standard Deviation|Mean
134193|NCT00523549|Secondary|Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E’) at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat||ratio||Standard Deviation|Mean
134194|NCT00523549|Secondary|Change in Left Atrial Size|Change from baseline in left atrial size at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat||cm||Standard Deviation|Mean
134195|NCT00523549|Primary|Change in Lateral Mitral Annular Myocardial Relaxation Velocity|Change from baseline in lateral mitral annular myocardial relaxation velocity (E’) at Week 24|Baseline to 24 weeks after treatment|Intent-to-treat||cm/s||Standard Deviation|Mean
134196|NCT00523419|Secondary|Overall Survival (OS) Time|OS was the duration from enrollment to death. For participants who lived, OS was censored at the last contact.|Baseline to 27.6 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.||months||95% Confidence Interval|Median
134197|NCT00523419|Secondary|Progression-Free Survival (PFS)|PFS was from date of study enrollment to first date of objectively determined progressive disease (PD) or death from any cause. For participants who did not die as of data cut-off date and who did not have objective PD, PFS was censored at date of last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from study drug) before objectively determined disease progression or death, PFS was censored at date of last objective progression-free disease assessment, before post-discontinuation chemotherapy.|Baseline to 10.4 months|Full analysis population: all participants who were treated with at least one dose of the study regimen.||months||95% Confidence Interval|Median
134198|NCT00523419|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from the first objective status assessment of CR or PR to the first date of progression or death as a result of any cause: CR was achieved if all tumor lesions disappeared; PR was achieved if there was >=30% decrease in sum of the longest diameter (LD) of target lesions (reference: baseline sum LDs) or complete disappearance of target lesions with persistence (but not worsening) of >=1 nontarget lesions and no appearance of new lesions.|Baseline to 31 months|Tumor response population: participants with best overall response of complete response (CR) and partial response (PR).||months|||Number
134199|NCT00523419|Secondary|Number of Participants With Adverse Events (Pharmacology Toxicity)|Pharmacology toxicity was defined as serious and non-serious adverse events. Summaries of these adverse events are located in the Reported Adverse Event Section.|Baseline to 21 months|Full analysis population: all participants who were treated with at least one dose of the study regimen||participants|||Number
134200|NCT00523419|Secondary|Correlation of Disease Outcome With Pharmacogenomic Analysis|It was planned to examine methylthioadenosine phosphorylase (MTAP) gene deletion, folate receptor alpha (FRα) and folylpoly-gamma-glutamate synthetase (FPGS) expression, and to correlate the results with the clinical data to determine the association between these factors and clinical outcome to treatment. However, due to the small number of participants with partial response (n=1), the planned statistical analyses that would correlate responders/non responders with pharmacogenomics data are no longer valid and the analyses were not conducted.|Baseline to 21 months|Since this outcome measure was not analyzed due to the inadequate number of responders, zero participants were analyzed.||correlation coefficient|||Number
134201|NCT00523419|Secondary|Time to Treatment Failure|When the protocol was written, time to treatment failure (TTTF) was included as a secondary endpoint. However, it was subsequently realized that due to the design of the study, participants are treated until disease progression or discontinuation from study treatment, not for a fixed number of cycles. Therefore, it was concluded that analysis of TTTF was inappropriate with the current study design and the analysis was not conducted, since it would be essentially the same as Progression-Free Survival.|Baseline to 21 months|Since this outcome measure was not analyzed due to the study design, zero participants were analyzed.||days||Standard Deviation|Mean
134202|NCT00523419|Primary|Percentage of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis * 100.|Baseline to 21 months|Participants who qualified for tumor response analysis are those with histological evidence of high grade locally advanced or metastatic osteosarcoma and treatment with at least 1 dose of study drug. Three participants died before the first tumor assessment and 1 participant discontinued without any tumor assessments and were considered Unknown.||percentage of participants||95% Confidence Interval|Number
134203|NCT00523367|Secondary|COPD/GERD Patients Treated With High Dose Esomeprazole|COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.|1 year||||||
134204|NCT00523367|Primary|Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.|The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.|1 year|||participants|||Number
134205|NCT00523341|Secondary|Bone Histology|Bone biopsy samples were prepared according to standard procedures for bone histology and bone histomorphometry to determine if there were any histological abnormalities in the bone. Results are reported for the number of participants with biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.|Month 24 and month 84|Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 evaluable bone biopsy at extension month 24 or extension month 84.||participants|||Number
134206|NCT00523341|Secondary|Serum Denosumab Concentration|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification.|Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose)|Participants who participated in the Study 20030216 PK substudy, for whom dosing information was not missing and for whom sampling was within 14 days of specified sampling times.||ng/mL||Standard Deviation|Mean
134207|NCT00523341|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10||Baseline (of extension study) and day 10|Participants who had a calcium corrected by albumin measurement within the Day 10 visit window up to May 31, 2008.||percent change||Inter-Quartile Range|Median
134208|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in P1NP by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
134209|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in CTX-1 by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
134476|NCT00520572|Secondary|American College of Rheumatology 70 Response (ACR70) at 6 Months|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment|6 months|||Participants|||Number
134210|NCT00523341|Secondary|Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
134211|NCT00523341|Secondary|Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit|Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.|Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84|"Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. n indicates the number of participants with available data at each time point."||percent change||Inter-Quartile Range|Median
134212|NCT00523341|Secondary|Number of Participants With Non-Vertebral Fractures|Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|84 months|All enrolled participants||participants|||Number
134213|NCT00523341|Secondary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.|84 months|All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit.||participants|||Number
134214|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit|1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134215|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134216|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134217|NCT00523341|Secondary|Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.|Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134218|NCT00523341|Secondary|Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit|1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134219|NCT00523341|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit|Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134220|NCT00523341|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density by Visit|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134221|NCT00523341|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline (of extension study) and months 12, 24, 36, 60 and 84|"Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. n indicates the number of participants with available data at each time point."||percent change||95% Confidence Interval|Least Squares Mean
134222|NCT00523341|Primary|Number of Participants With Antibodies to Denosumab||Every 12 months through Month 84|All participants who received at least 1 dose of denosumab||participants|||Number
134224|NCT00523341|Primary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.|84 months|All participants who received at least one dose of denosumab.||participants|||Number
134225|NCT00523237|Primary|The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir|evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir|24 weeks|With expected man baseline residual viremia of 5 copies/ml and predicted standard deviation of 3 in change of residual viremia, our study was predicted to have 80% power to detect a difference of 2.5 copies/ml in residual viremia with =0.05.||percentage|||Number
134226|NCT00522951|Secondary|Intraclass Correlation Coefficient (ICC) Among 3 Blinded Readers on the Number of Detected Lesions|ICC among 3 blinded readers calculated for number of detected lesions using the statistical model with two random effects, i.e., blinded readers and individual patients.|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||ICC|||Number
134227|NCT00522951|Secondary|Contrast Noise Ratio (CNR) of Lesions Evaluated by Independent Radiologist|CNR of lesion/normal white matter based on the signal intensity of MR images evaluated by independent radiologist (mean and standard deviation of 306 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||CNR||Standard Deviation|Mean
134228|NCT00522951|Secondary|Lesion Size Evaluated by Independent Radiologist|Size of each lesion on postcontrast MR images evaluated by independent radiologist (mean and standard deviation of 603 lesions)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||mm||Standard Deviation|Mean
134229|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by Investigator|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
134230|NCT00522951|Secondary|Number of Participants With Reasons for Performance in SRS Planning by TPE|Reasons for comparison results of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator (multiple answers applicable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
134231|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by Investigator|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
134232|NCT00522951|Secondary|Number of Participants With Performance in Stereotactic Radiosurgery (SRS) Planning by TPE|Comparison of overall image quality for SRS treatment planning between gadobutrol and gadoteridol by TPE|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), whose images were assessed as “confident in treatment planning” with gadobutrol and ProHance, and who were assessed as applicable for SRS, and had valid data for this Outcome Measure||participants|||Number
134233|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
134234|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.2 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by TPE|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.2 mmol/kg bw and gadoteridol 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
134235|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Investigator|Treatment planning confidence evaluated separately for each image set (gadobutrol 0.1 mmol/kg bw and gadoteridol 0.2 mmol/kg) by investigator (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
134477|NCT00520572|Secondary|American College of Rheumatology 50 Response (ACR50) at 6 Months|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment.|6 months|||Participants|||Number
134236|NCT00522951|Secondary|Treatment Planning Confidence - Gadobutrol 0.1 mmol/kg bw vs. Gadoteridol (ProHance) 0.2 mmol/kg bw by Treatment Planning Experts (TPE)|Treatment planning confidence evaluated separately for each image set (gadobutrol [Gado-] 0.1 mmol/kg bw and gadoteridol [Pro-] 0.2 mmol/kg) by TPE (category: not confident, confident, and not assessable)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||participants|||Number
134237|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Investigator|Border delineation for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
134238|NCT00522951|Secondary|Score of Visibility Assessment - Border Delineation by Blinded Reader|Border delineation for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=None, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
134239|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Investigator|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by investigator (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
134240|NCT00522951|Secondary|Score of Visibility Assessment - Degree of Lesion Contrast Enhancement by Blinded Reader|Degree of contrast enhancement for each lesion on postcontrast MR images using the 4-point scale by averaged blinded reader (Score 1=No, 2=Moderate, 3=Good, 4=Excellent)|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||scores on a scale||Standard Deviation|Mean
134241|NCT00522951|Primary|Number of Lesions Detected by Blinded Readers (BR) and Investigator|Number of metastatic lesions (unenhanced and enhanced) per participant detected on postcontrast Magnetic resonance (MR) images by averaged blinded reader and investigator|one day|Participants without a major protocol deviation or conditions that could affect his or her efficacy evaluation (Per Protocol Set), with valid data for this Outcome Measure.||lesions||Standard Deviation|Mean
134242|NCT00522925|Secondary|Change From Baseline in Mean Seated Systolic and Diastolic Blood Pressure||4 weeks of treatment with PS43540||||||
134243|NCT00522925|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure||4 weeks of treatment with PS43540||||||
134244|NCT00522925|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure||4 weeks of treatment with PS43540|||mmHg||95% Confidence Interval|Mean
134245|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 10 to 12 of Treatment|The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 10 to Month 12|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations||Participants|||Number
134246|NCT00522873|Secondary|Number of Participants With Amenorrhea During Month 1 to 3 of Treatment|The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval.|Month 1 to Month 3|Per protocol set (PPS): All subjects from the FAS who had at least 75% overall study drug compliance and no major protocol violations||Participants|||Number
134247|NCT00522873|Primary|Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment)|The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only.|Up to one year|For the DRSP/E2 group only - Primary analysis set (PAS): All subjects from the full analysis set (FAS) who either had a biopsy result classified as ‘normal’ or ‘hyperplasia or worse’ after a year of treatment or who prematurely discontinued the study before Cycle 13 with a biopsy classified as ‘hyperplasia or worse’.||Participants|||Number
134248|NCT00522795|Primary|Complete Pathologic Response|Per pathology review post surgery|At Surgery approximately 4weeks after last treatment|Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma.||participants|||Number
134249|NCT00522626|Secondary|Maternal Physiologic Parameters||120 minutes||||||
134250|NCT00522626|Primary|Fetal Heart Rate|Fetal heart rate in beats per minute|60 minutes|Total number of subjects completing assessment||beats per minute||Standard Deviation|Mean
134251|NCT00522457|Secondary|Clinical Benefit Rate|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed||participants|||Number
134252|NCT00522457|Secondary|Duration of Response|The study was prematurely terminated, therefore no participants were analyzed|patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed||participants|||Number
134253|NCT00522457|Primary|Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)||patients are monitored for 6 months|The study was prematurely terminated, therefore no participants were analyzed. The primary endpoint was the objective response rate (ORR) to ertumaxomab (best response during the course of the study), defined as the number of patients with CR or PR according to RECIST, relative to the total population of treated patients||participants|||Number
134254|NCT00522431|Secondary|To Replace Testosterone in Hypogonadal Males so That the Maximum Serum Total Testosterone (Cmax) on Day 90 Lies Within Specific Limits. To Determine the Safety of Fortigel Testosterone Gel 2.0% in Hypogonadal Males.||90 days||||||
134255|NCT00522431|Primary|The Primary Objective of This Study is to Replace Testosterone in Hypogonadal Males so That the Time Averaged Serum Total Testosterone (Cavg) on Day 90 Lies Within Specific Limits Within a Pre-specified Percentage of Patients.||90 days|||ng/dL||Standard Deviation|Mean
134256|NCT00522418|Secondary|Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures|The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134257|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms VNS + BMP (N=17) and BMP alone (N=17), with an overall QOLIE-89 at baseline and any other baseline visit up to 12 months. Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40||units on a scale||Standard Error|Least Squares Mean
134258|NCT00522418|Secondary|Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40|QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Change from baseline up to 12 months|This outcome measure includes patients from both arms, VNS + BMP (N=30) and BMP alone (N=31), with an overall QOLIE-89 at baseline and any other post baseline visit up to 12 months. Subgroup Analysis of population with Baseline Adverse Event Profile Score >= 40||Units on a Scale||Standard Error|Least Squares Mean
134259|NCT00522418|Secondary|Percent of Participants Who Were Compliant With the Protocol|Retention rate in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134260|NCT00522418|Secondary|Change in the Number of Anti-epileptic Drugs Prescribed|Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134261|NCT00522418|Secondary|Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134262|NCT00522418|Secondary|Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134263|NCT00522418|Secondary|Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134264|NCT00522418|Secondary|Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134265|NCT00522418|Secondary|Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal|Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134266|NCT00522418|Secondary|Retention Rate|Percent of participants who were compliant with the protocol.|At 12 and 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134268|NCT00522418|Secondary|Change From Baseline in Adverse Event Profile (AEP) Score|Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.|Mean change from baseline AEP Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a scale||Standard Deviation|Mean
134269|NCT00522418|Secondary|Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months|The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Mean change from baseline CGI-I Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a Scale||Standard Deviation|Mean
134270|NCT00522418|Secondary|Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score|The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.|Mean change from baseline NDDI-E Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a Scale||Standard Deviation|Mean
134271|NCT00522418|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score|The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.|Mean change from baseline CES-D Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Units on a Scale||Standard Deviation|Mean
134272|NCT00522418|Secondary|Seizure Free Days Over the Last 6 Months||Over the last 6 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134273|NCT00522418|Secondary|Seizure Free Days|Seizure free days is defined as the time from last seizure to study exit date.|From the patient's last seizure to the study exit date|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134274|NCT00522418|Secondary|Mean Percent Change in Seizure Frequency|Percent change in total seizuires per week from baseline at 12 months|Mean percent change from baseline in seizure frequency at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||Percent Change||Standard Deviation|Mean
134275|NCT00522418|Secondary|Percent of Patients That Are Seizure Free|Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.|3, 6, 9, 12, 15, 18, 21, 24 months|This study was conducted between February 2006 and July 2008 and was prematurely terminated by Cyberonics, Inc. due to a low enrollment rate and not as a result of a safety or efficacy signal. Because of early termination and limited data this outcome measure was not tabulated.|||||
134276|NCT00522418|Secondary|Response Rate|Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.|Number of Responders at 12 Months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||participants|||Number
134277|NCT00522418|Primary|Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment|QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.|Mean change from baseline QOLIE-89 Overall Score at 12 months|Due to early study termination & only a few patients (n=7) achieving 2 year follow-up, study data for the 24 month time point is not available. However, at the 12 month time point there was an adequate amount of patient study data for analysis. This outcome measure evaluates the data for sixty (60) patients.||units on a scale||Standard Deviation|Mean
134278|NCT00522392|Secondary|Change in Quality of Life (QOL) From Baseline to 6 Months Post Consolidation as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI)|The combined score on the FACT-Ntx TOI is of interest. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible quality of life) -100 (best possible quality of life). The primary QOL endpoint is defined as the change in the FACT-Ntx TOI score from registration to 6 months post consolidation treatment.|Baseline and 6 months post consolidation treatment|Patients with both assessments complete at baseline and 6 months post consolidation treatment were included in this analysis.||units on a scale||Full Range|Mean
134280|NCT00522392|Secondary|Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])|"CR:~Patients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria:~Negative immunofixation on the serum and urine at two consecutive times~Disappearance of any soft tissue plasmacytomas~≤5% plasma cells in bone marrow~If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times~VGPR:~Serum and urine M-component detectable by immunofixation but not on electrophoresis OR~>=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP)~If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a >90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria"|Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|Patients with measurable disease at randomization were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
134281|NCT00522392|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to the earliest documentation of disease progression (PD) or death. If a patient died without evidence of PD, the patient was considered an event if death occurred within 3 months of the last disease assessment. Patients who died outside of the specified interval or patients who were alive without evidence of PD were censored at the date of last disease assessment.~The PFS results are based on data as of August 2012, while overall survival (OS) was updated in April 2014. Given the early termination and limited sample size, data management efforts to update PFS were not pursued."|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years|All randomized patients||Months||95% Confidence Interval|Median
134282|NCT00522379|Secondary|"The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis. The Observed Cases (OC) method was utilized.||Hours||Standard Deviation|Mean
134283|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?|"Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134284|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?|"Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134285|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?|"Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134286|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average?"|"Item = What proportion of the waking day is the subject “off”, on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 – 4 points (4 = maximum). A higher score indicates the subject is “off” a larger portion of the waking day.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134357|NCT00521365|Secondary|Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|"Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF).~SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18."|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
134287|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly?"|"Item = Do “off” periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods come on suddenly, within a few seconds.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134288|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable?"|"Item = Are “off” periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods are unpredictable.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134289|NCT00522379|Secondary|"The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable?"|"Item = Are “off” periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates “off” periods are predictable.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134290|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia|"Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||participants|||Number
134291|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?|"Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||participants|||Number
134292|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?|"Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||participants|||Number
134293|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?|"Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 – 4 points (4 = maximum). A higher score indicates more severe symptoms.~Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same."|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||participants|||Number
134294|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 496 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||units on a scale||Standard Deviation|Mean
134295|NCT00522379|Secondary|The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 497 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.||units on a scale||Standard Deviation|Mean
134296|NCT00522379|Secondary|The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary||From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis.||Hours||Standard Deviation|Mean
134297|NCT00522379|Secondary|"The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “On” is defined as when the patient has the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||Hours||Standard Deviation|Mean
134298|NCT00522379|Secondary|"The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “On” is defined as when the patient has the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward method was utilized.||Hours||Standard Deviation|Mean
134299|NCT00522379|Secondary|"The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||Hours||Standard Deviation|Mean
134300|NCT00522379|Primary|"The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary"|Time “Off” is defined as when the patient does not have the effect of anti-Parkinson’s medication.|From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].|Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.||Hours||Standard Deviation|Mean
134301|NCT00522301|Primary|Progression-free Survival (PFS) Rate at 12 Months|All 5 patients experienced a rash. As a result, all 5 were either advised to withdraw from the protocol, or withdrew themselves from the protocol. The outcome was not met.|1 year|Protocol terminated prior to primary outcome evaluation. All 5 patient were evaluable for toxicity only.|||||
134302|NCT00522275|Secondary|Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.|Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.||percentage of subjects|||Number
134303|NCT00522275|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)|Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.|Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)|Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.||percentage change||Full Range|Median
134304|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)|Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
134305|NCT00522275|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
134306|NCT00522275|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (Maximum 6 years)|Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||subjects|||Number
134307|NCT00522171|Secondary|Total Number of Hours From Drain Placement to Drain Removal|Total number of hours from drain placement to drain removal|From drain placement to drain removal (</= 770 hours)|terminated study||hours||Standard Deviation|Mean
134308|NCT00522171|Primary|Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal|Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure|From the time of drain placement to time of drain removal (</= 770 hours)|ITT||milliliter||Standard Deviation|Mean
134309|NCT00522041|Secondary|Percentage of Responders|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18.|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.||Percentage of responders|||Number
134310|NCT00522041|Secondary|Time to an Improvement in Pain Intensity|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity.|Baseline to Day 21|Intent-to-treat population: All randomized participants who had applied the study medication at least once. Only participants with an improvement in pain intensity were included in the analysis.||Days||Standard Error|Mean
134311|NCT00522041|Primary|Change From Baseline in Pain Intensity at Days 14-18|Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled “least possible pain” and the right-end of the visual analog scale was labelled “worst possible pain”. The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement.|Baseline to Day 18|Intent-to-treat population: All randomized participants who had applied the study medication at least once.||Units on a scale||Standard Error|Mean
134312|NCT00521989|Secondary|To Assess the Efficacy of the CRx-102 Compared to Placebo on the Change From Baseline to Day 98 Using the Full WOMAC Pain, Stiffness, Physical Function Parameters, and Patient Global Assessment VAS.||Day 98||||||
134313|NCT00521989|Primary|Change From Baseline to Day 98 Using the WOMAC Pain Question #1|"The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface. This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with No Pain on the left (0 mm) and Extreme Pain on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome."|Baseline to Day 98|ITT population||millimeters||Standard Deviation|Mean
134314|NCT00521976|Secondary|Recurrent Troponin-T (TnT) Positive Events|Recurrent Troponin-T (TnT) positive events; Symptoms of coronary ischemia associated with TnT >0.05 ng/mL with a pattern of gradual rise and fall in TnT|24 months.|||Participants|||Number
134315|NCT00521976|Primary|Total Mortality.||24 months.|||Participants.|||Number
134316|NCT00521924|Secondary|DAS 28 at Baseline vs at Week 38; Quality of Life; American College of Rheumatology (ACR) Response Disease Progression (X-ray); Effect of Inflammatory Markers on Response and Disease Progression; Assess Simplified Disease Activity Index (SDAI).|These were not prespecified key secondary outcomes; therefore, results will not be disclosed.|Weeks 14, 38, and 62||||||
134317|NCT00521924|Primary|Number of Patients in Remission According to Disease Activity Score (DAS) 28 (< 2.6)|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Patients can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|after 38 weeks|This trial terminated early due to poor enrollment. Since none of the randomized patients reached Week 38, no change of DAS28 between baseline and Week 38 could be analyzed.|||||
134318|NCT00521599|Primary|Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.|Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64.|Baseline and Week 8 End|All treated subjects included all but one placebo-treated subject from the All Randomized Subjects data set, who was randomized, but never treated in either the open-label or double-blind Treatment Periods due to non-compliance with the protocol||liters/minute||Standard Deviation|Least Squares Mean
134319|NCT00521586|Other Pre-specified|Percentage of Participants With Serious Adverse Events (SAEs) or Non-serious Adverse Events (Non-SAEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Non-serious AEs are AEs excluding SAEs. In Years 1-4, only deaths and withdrawals due to AEs or SAEs were to be recorded in the case report form.|Signing of informed consent up to 194 days after re-vaccination at Year 5|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
134320|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After 13vPnC (Year 5)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity).|Within 30 Minutes After 13vPnC (Year 5)|Safety population at Year 5 included all participants who had received at least 1 vaccination and did not lack any safety data.||percentage of participants|||Number
134413|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Medication (Cmax)|The maximum observed plasma concentration of apremilast (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 1, 85, and 169/170, respectively.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
134321|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 2 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant's arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination (Dose 2, year 0) and did not lack any safety data.||percentage of participants|||Number
134322|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Acute Pain Within 30 Minutes After Dose 1 (Year 0)|Acute pain was not prompted in the electronic diary however were recorded in a specific page of the case report form (CRF). Acute pain at injection site pain occurred within 30 minutes of vaccination and was scaled as: Any (pain present); Mild (easily tolerated); Moderate (discomfort interfering the usual activity); Severe (Incapacitating with inability to do usual activity). Acute pain was measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 30 Minutes After Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data.||percentage of participants|||Number
134323|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After 13vPnC (Year 5)|Percentage of participants who experienced specific systemic events (Fever: >= 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.||percentage of participants|||Number
134324|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 2 (Year 0)|Percentage of participants who experienced specific systemic events (absent: 38.0 degrees Celsius [C], mild: 38.0 to 38.4 degrees C, moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening > 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
134325|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Dose 1 (Year 0)|Percentage of participants who experienced specific systemic events (mild: 38.0 to 38.4 degrees Celsius [C], moderate: 38.5 to 38.9 degrees C, severe: 39.0 to 40.0 degrees C and potentially life threatening greater than [>] 40.0 degrees C), chills, fatigue, headache, vomiting, decreased appetite, rash, new generalized muscle pain, aggravated generalized muscle pain, new generalized joint pain, and aggravated generalized joint pain prompted for each day were reported using an electronic diary.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
134326|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After 13vPnC (Year 5)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder).|Within 14 days after 13vPnC (Year 5)|The safety population at Year 5 included participants who received both (Year 0 and Year 5) 13vPnC and had some safety results at Year 5. Here, n=number of participants with known values.||percentage of participants|||Number
134327|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 2 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 2 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here,n=number of participants with known values.||percentage of participants|||Number
134358|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
135033|NCT00516906|Primary|Clinician Overall Satisfaction With Catheter Securement|Clinician Overall Satisfaction with Catheter Securement Five Point Scale: 1 = Very Good, 5= Very Poor|Daily up to 7 Days (average 3-7 days of wear)|||Units on a scale||Standard Deviation|Mean
134328|NCT00521586|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Dose 1 (Year 0)|Specific local reactions were prompted for each day,and reported using an electronic diary.Redness and Swelling were scaled as Any(redness present or swelling present);Mild(2.5 to 5.0 centimeters [cm]);Moderate(5.1 to 10.0 cm);Severe (>10 cm). Pain at injection site was scaled as: Any (pain present); Mild (awareness of sign or symptom, but easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, with inability to do usual activity). Limitation of arm movement was scaled as Any(no limitation of arm movement);Mild(some limitation of arm movement);Moderate (unable to move arm above head but able to move arm above shoulder);Severe (unable to move arm above shoulder). Local reactions were measured only on the participant’s arm vaccinated with either 13vPnC or placebo and were not collected at the TIV injection site.|Within 14 days after Dose 1 (Year 0)|Safety population included all participants who had received at least 1 vaccination and did not lack any safety data. Here, n=number of participants with known values.||percentage of participants|||Number
134329|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and the specified timepoints.||fold-rises||95% Confidence Interval|Geometric Mean
134330|NCT00521586|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1(Dose 1, placebo+TIV). Placebo matched to 13vPnC was administered 1 month after(Dose 2, placebo), or 13vPnC was administered 1 month after (Dose 2, 13vPnC).Participants were further followed-up for 1 month,then attended a 6-month follow-up visit for safety.Participants were then followed-up yearly for 4 years.Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination.Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Years 0 through Year 5 within the protocol specified time window. Here, n=number of participants with valid and determinate assay results for the specified serotype at the given time points.||mcg/mL||95% Confidence Interval|Geometric Mean
134331|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from Before 13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|Before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
134332|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
134359|NCT00521365|Secondary|Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.|Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life).|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
134430|NCT00521053|Secondary|Progression Free Survival (PFS)|Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or significant worsening of non-target disease (e.g., a measurable increase in non-target lesions or the appearance of new lesions) indicative of disease progression.|52 weeks|||Months||95% Confidence Interval|Median
134333|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
134334|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
134335|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
134336|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Participants in this population must have immunogenicity data at both Year 5 time points.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||mcg/mL||95% Confidence Interval|Geometric Mean
134337|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) 1 Month After 13vPnC (Year 5)|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 1 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.||microgram per milliliter(mcg/mL)||95% Confidence Interval|Geometric Mean
134338|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC (Year 0),1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before to 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both the baseline and the various time points.|Before, 1 month after 13vPnC (Year 0), at years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window. n=participants with valid and determinate assay results for both the before 13vPnC (Year 0) and all the specified timepoints.||fold-rises||95% Confidence Interval|Geometric Mean
134360|NCT00521365|Secondary|Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).|Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
134339|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC (Year 0), 1, 2, 3, 4 Years After Initial Vaccination (Year 0); Before and 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. n=participants with valid and determinate assay results for the specified serotype at before, 1 month after 13vPnC (Year 0), at Years 1, 2, 3 and 4 after initial vaccination (Year 0), before, 1 month after 13vPnC (Year 5) blood draws.|Before,1 month after 13vPnC (Year 0), 1, 2, 3, 4 years after initial vaccination (Year 0); before,1 month after 13vPnC (Year 5)|Subset of all-available immunogenicity population with data at Years 0 through 5 included participants with immunogenicity data at all-time points from Year 0 through Year 5 within the protocol specified time window.||titers||95% Confidence Interval|Geometric Mean
134340|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before13vPnC (Year 0) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
134341|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.|before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype for both before 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||titers||95% Confidence Interval|Geometric Mean
134342|NCT00521586|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to 1 Month After 13vPnC (Year 0)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Years 0 and 5. n=participants with valid and determinate assay results for the specified serotype from both 1 month after 13vPnC (Year 0) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.||fold-rises||95% Confidence Interval|Geometric Mean
134343|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After 13vPnC (Year 0) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants in this population must have immunogenicity data at both the Year 0 and Year 5 time points.n=participants with valid and determinate assay results for the specified serotype for both 1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|1 month after 13vPnC (Year 0),1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 0 and 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.||titers||95% Confidence Interval|Geometric Mean
134344|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold-Rises (GMFRs) 1 Month After 13vPnC Re-vaccinated Dose (Year 5) Relative to Before 13vPnC (Year 5)|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined from before 13vPnC (Year 5) to 1 month after 13vPnC re-vaccinated dose (Year 5) and were summarized geometric means and 2-sided 95% CIs, which were computed using the logarithmically transformed assay results. CI for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. n=participants with valid and determinate assay results for the specified serotype from both before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws.|before 13vPnC (Year 5), 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis.||fold-rises||95% Confidence Interval|Geometric Mean
134345|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) Before 13vPnC (Year 5) and 1 Month After 13vPnC Re-vaccinated Dose (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Participants with immunogenicity data at both Year 5 endpoints.|before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5)|All-available immunogenicity population at Year 5.n=participants with valid and determinate assay results for the specified serotype at before 13vPnC (Year 5) and 1 month after 13vPnC re-vaccinated dose (Year 5) blood draws for each treatment arm, respectively.||titers||95% Confidence Interval|Geometric Mean
134346|NCT00521586|Other Pre-specified|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC (Year 5)|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of participants using a microcolony OPA (mcOPA) assay. GMTs (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 Month After 13vPnC (Year 5) blood draws. CI for GMTs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC (Year 5)|All-available immunogenicity population at Year 5 included participants who had at least 1 valid and determinate assay result related to the proposed analysis. n=participants with valid and determinate assay results for the specified serotype at 1 month after 13vPnC (Year 5) blood draws for each treatment arm, respectively.||titers||95% Confidence Interval|Geometric Mean
134347|NCT00521586|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose at year 0|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation. n=participants with valid and determinate assay results for the specified serotype at the given visit.||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
134348|NCT00521586|Primary|Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1|Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV – Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.|1 month after Dose 1|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation.||percentage of participants||95% Confidence Interval|Number
134349|NCT00521456|Post-Hoc|Visual Acuity|Patients with ≥ 3 line improvement in visual acuity|Change from baseline at Day 14|Modified Intent-to-Treat Population||Percentage of patients with ≥ 3 lines|||Number
134350|NCT00521456|Secondary|Mean Pupil Area|Pupil area post-irrigation and aspiration|Day 0|Modified Intent-to-Treat Population||millimeters squared (mm²)||Standard Deviation|Mean
134351|NCT00521456|Secondary|Ocular Pain|Measured on a scale of 0-4 (0 = none, 4 = intolerable)|Day 1|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
134352|NCT00521456|Primary|Resolution of Post Operative Inflammation|Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)|Day 14|Modified Intent-to-Treat Population||% of participants with a score of 0|||Number
134353|NCT00521365|Secondary|Number of Participants With >7% Increase in Weight|Number of participants with >7% increase in weight from baseline to end of study.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Participants|||Number
134354|NCT00521365|Secondary|Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||cm||Standard Deviation|Mean
134355|NCT00521365|Secondary|Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).||Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Kg||Standard Deviation|Mean
134356|NCT00521365|Secondary|Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).|Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
135117|NCT00515827|Secondary|Number of Participants Who Discontinued Study Drug|Participants who discontinued randomized study treatment for any reason|From first day of treatment to week 12|All 53 participants||Participant|||Number
134361|NCT00521365|Secondary|Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).|Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse.|Baseline and 3 weeks|Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
134362|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).|"Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward|||Participants|||Number
134363|NCT00521365|Secondary|Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)|"Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60."|21 days ± 2 days or Last Observation Carried Forward|||Participants|||Number
134364|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3|Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 2 weeks|Outcome was comparing the data at baseline with the specific data at visit 3 (not with the LOCF), since only 79 patients completed YMRS at visit 3 the number of patients analyzed is different respect to the LOCF (88).||Scores on a scale||Standard Deviation|Mean
134365|NCT00521365|Secondary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.|Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60.|Baseline and 1 week|Outcome was comparing the data at baseline with the specific data at visit 2(not with the LOCF), since only 78 patients completed YMRS at visit 2 the number of patients analyzed is different respect to the LOCF (88).||Scores on a scale||Standard Deviation|Mean
134366|NCT00521365|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)|Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline and 3 weeks|Modified Intention to treat patients (88). Patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline.||Scores on a scale||Standard Deviation|Mean
134367|NCT00521352|Secondary|Clinical Improvement (CGI-S)|"Minimum CGI-S score: 1 Maximum CGI-S score: 7~Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.~Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.~= Normal, not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients"|4 weeks|||responders (CGI-S = 1 or 2)|||Number
134368|NCT00521352|Primary|Hamilton Depression Rating Scale (HDRS), 28 Item Version|"The Hamilton Rating Scale for Depression (HRSD) is a multiple item questionnaire used to provide an indication of depression severity. The 28-, rather then 17- or 24-, item version was used to assess subjects in this protocol.~28-item minimum score = 0 28-item maximum score = 84~Higher scores indicate high levels of symptomatology. Reduction in score from baseline indicates clinical symptom improvement."|4 weeks|||responders|||Number
134369|NCT00521352|Primary|Panic Disorder Severity Scale (PDSS)|"The Panic Disorder Severity Scale is a questionnaire developed for measuring the severity of panic disorder symptoms.~The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28.~Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms."|4 weeks|||responders|||Number
134370|NCT00521339|Secondary|Mean Residence Time (MRT) During the Extension Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Days169/170) was calculated as follows: Cavg = (Day 169/170)/(12)|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||hours||Geometric Coefficient of Variation|Geometric Mean
134371|NCT00521339|Secondary|Accumulation Index During the Extension Phase|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Not able to calculate the Accumulation Index at this time point; insufficient data collection for this calculation.|||||
134372|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Extension Phase|For Days 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC12) where λ = the terminal elimination rate constant|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||mL||Geometric Coefficient of Variation|Geometric Mean
134373|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CL/F) During the Extension Phase|For 169/170, apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC12|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.||mL/hour||Geometric Coefficient of Variation|Geometric Mean
134374|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½) During the Extension Phase|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||hours||Geometric Coefficient of Variation|Geometric Mean
134375|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Extension Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 169/170. Actual times utilized were used for reporting Tmax values.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||hours||Geometric Coefficient of Variation|Geometric Mean
134376|NCT00521339|Secondary|Peak (Maximum) Plasma Concentration of Apremilast (Cmax) During the Extension Phase|The maximum observed plasma concentration of CC-10004 (Cmax); the maximum plasma concentration (Cmax) was obtained directly from the observed concentration-time data on Days 169/170.|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
134377|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12) During the Extension Phase|Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS).|Day 169 pre-dose, 0.5, 1, 2, 4, 8 12, 24 and 36 hours after AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
134378|NCT00521339|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item Health Survey (SF-36) Scores, Mental and Physical Components to Week 12|The SF-36 was a self-administered instrument consisting of 8 multi-item scales that assess 8 health domains: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. A higher score post-baseline is indicative of improvement in the disease state. The summary physical health score included physical functioning, role-physical, bodily pain and general health. The summary mental health score included: vitality, social functioning, role-emotional and mental health. The resulting score for each subscale is then standardized, to obtain values ranging from 0 to 100, with higher values indicating a better QOL.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||units on a scale||Standard Deviation|Mean
134379|NCT00521339|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12|DLQI was the dermatology-specific quality of life (QOL) measure used for the psoriatic population. The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on a participants QoL, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Possible responses for each of the 10 items are: not at all, a little, a lot, and very much. Each question is rated on a scale of 0 to 3 with a total range of 0 to 30. Higher scores indicate greater impact of disease on QOL|Baseline to Week 12|Only those with both a baseline and final/termination visit assessment were included in the analyses of change from baseline. Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||units on a scale||Standard Deviation|Mean
134380|NCT00521339|Secondary|Percent Change From Baseline in the Dendritic Cell (CD83) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134381|NCT00521339|Secondary|Percent Change From Baseline in the IL2 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134382|NCT00521339|Secondary|Percent Change From Baseline in the Chemokine Ligand (CXCL9) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
140359|NCT00466505|Secondary|One Year Survival Rate|Percent of patients who remain alive one year from on-study date|1 year from on-study date|||Percentage of participants||95% Confidence Interval|Number
134383|NCT00521339|Secondary|Percent Change From Baseline in the IL10 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134384|NCT00521339|Secondary|Percent Change From Baseline in the Interferon (INF) Gamma Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134385|NCT00521339|Secondary|Percent Change From Baseline in the Tumor Necrosing Factor (TNF) Alpha Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Week 0 to Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134386|NCT00521339|Secondary|Percent Change From Baseline in the IL17A Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134387|NCT00521339|Secondary|Percent Change From Baseline in the MX1 (Gene That Encodes the Interferon-induced p78 Protein) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134388|NCT00521339|Secondary|Percent Change From Baseline in the IL8 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134389|NCT00521339|Secondary|Percent Change From Baseline in the pluripotent19 (P19) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134390|NCT00521339|Secondary|Percent Change From Baseline in the keratin16 (K16) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134391|NCT00521339|Secondary|Percent Change From Baseline in the Defensin Beta 4 (DEFB4) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) i being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134401|NCT00521339|Secondary|Percent Change From Baseline of CD11c in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134392|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Extension Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.~Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event."|Week 12 to Week 24|Safety population consisted of all participants who were enrolled and received at least one dose of study medication in treatment Extension Phase.||participants|||Number
134393|NCT00521339|Secondary|Percent Change From Baseline in the p40 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134394|NCT00521339|Secondary|Percent Change From Baseline in the Interleukin (IL) IL-22 Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134395|NCT00521339|Secondary|Percent Change From Baseline in the Inducible Nitric Oxide (iNOS) Inflammatory Marker in Psoriatic Skin Biopsies|Inflammatory markers associated with psoriasis (using skin biopsies) were used to detect acute inflammation and as markers of treatment response. The inflammatory markers were measured using Reverse transcriptase polymerase chain reaction (RT-PCR) and the messenger Ribonucleic acid (mRNA) is being measured.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Inflammatory Marker in Psoriatic Skin Biopsies at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134396|NCT00521339|Secondary|Percent Change From Baseline of Epidermal Thickness in the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134397|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134398|NCT00521339|Secondary|Percent Change From Baseline of Langerin in the Dermis of Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134399|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134400|NCT00521339|Secondary|Percent Change From Baseline of CD56 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
140360|NCT00466505|Secondary|Overall Survival|Median survival time in months, from on-study date to date of death|On study date to off study date in this study with median 9.76 months|||Months||Inter-Quartile Range|Median
134402|NCT00521339|Secondary|Percent Change From Baseline of CD 11c in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134403|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Epidermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134404|NCT00521339|Secondary|Percent Change From Baseline of CD3 in the Dermis of the Psoriatic Skin Biopsy at Week 12|The aim of the study was to measure the pharmacodynamic effects of apremilast in participants with plaque psoriasis in skin affected by psoriasis, immune cells enter the skin through blood vessels and cause the epidermis to grow very rapidly and to stop shedding properly. This causes thickening of the skin as well as the scaly build up composed of dead skin cells seen on areas affected by psoriasis.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the Psoriatic Skin Biopsy at Baseline and Week 12. Participation was optional for the pharmacodynamic portion of the study.||percent change||Full Range|Median
134405|NCT00521339|Secondary|Change From Baseline in Peripheral Blood T Cell, B Cell, and NK Cell Subsets at Week 12|T cells or T lymphocytes, a type of white blood cell, play a role in cell-mediated immunity. T cells are distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on the cell surface and mature in the thymus. B cells, a type of lymphocyte in the humoral immunity of the adaptive immune system can be distinguished by the presence of a protein on the B cells outer surface called a B cell receptor (BCR). This receptor protein allows a B cell to bind to a specific antigen and make antibodies against antigens [(antigen-presenting cells APCs)], and to develop into memory B cells after activation by antigen interaction. Natural Killer Cells (NK) are a type of cytotoxic lymphocyte critical to the innate immune system. Their role is analogous to that of cytotoxic T cells in the vertebrate adaptive immune response. They constitute the third kind of cells differentiated from the common lymphoid progenitor generating B and T lymphocytes and mature in the bone marrow.|Baseline and Week 12|Population includes participants who took at least 1 dose of study medication and were measured for the peripheral blood T cell, B cell and NK cell subsets at Baseline and Week 12.||percentage of lymphocytes||Standard Deviation|Mean
134406|NCT00521339|Secondary|Mean Residence Time (MRT) During the Treatment Phase|Mean Residence Time (MRT) is defined as the mean duration of time the drug spends in the body. The average concentration at steady state (Cavg) (for Day 85 was calculated as follows: Cavg = (Day 85 AUC0-12)/(12).|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast||hours||Geometric Coefficient of Variation|Geometric Mean
134407|NCT00521339|Secondary|Accumulation Index (R)|Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||ratio||Geometric Coefficient of Variation|Geometric Mean
134408|NCT00521339|Secondary|Apparent Total Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) During the Treatment Phase|"Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) (for Days 1, 85, and 169/170)~For Day 1, Vz/F was not calculated.~For Days 85 and 169/170, apparent volume of distribution of drug (V/z) based on the terminal phase was calculated as follows: Vz/F=Dose/(λ*AUC^12)"|Day 85|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||mL||Geometric Coefficient of Variation|Geometric Mean
134409|NCT00521339|Secondary|Apparent Total Clearance of Apremilast From Plasma After Extravascular Administration (CLz/F) During the Treatment Phase|"The apparent total clearance of apremilast from plasma after extravascular administration (CLz/F); for Day 1, apparent clearance of drug from plasma (CL/F) was not calculated.~For Day 85, Apparent clearance of drug from plasma after extravascular administration (CL/F) was calculated as follows: CL/F= Dose/AUC^12 where τ=12."|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast. This analysis was performed for participants with normal renal function only.||mL/hour||Geometric Coefficient of Variation|Geometric Mean
134410|NCT00521339|Secondary|Terminal Phase Elimination Half Life of Apremilast (t½)|Terminal phase elimination half-life (t1/2) was calculated as follows: t1/2 = 0.693/λz. The terminal elimination rate constant (λZ) was estimated by linear regression of the log-transformed concentration-time data.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||Liters||Geometric Coefficient of Variation|Geometric Mean
134411|NCT00521339|Secondary|Time to Maximum Plasma Concentration (Tmax) During the Treatment Phase|The time to reach Cmax (Tmax) was obtained directly from the observed concentration-time data on Day 85. Actual times utilized were used for reporting Tmax values.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast.||hours||Full Range|Median
134412|NCT00521339|Secondary|Trough Plasma Concentration (Cmin)|The trough observed plasma concentration of apremilast (Cmin) was determined directly from the observed pre-AM dose concentration on Day 85.|Day 85 Pre-dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for apremilast||ng/mL||Geometric Coefficient of Variation|Geometric Mean
134414|NCT00521339|Secondary|Area Under the Plasma Concentration Time-curve From 0 to 12 Hours Post Dose (AUC 0-12)|Plasma concentrations of apremilast were determined using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). For Day 1, AUC0-12 was calculated, using linear trapezoidal area method in WinNonlin (linear-linear trapezoidal). For Days 85 and 169/170, the AUC during a dosing interval (12 hours) (AUC0-12), was calculated at steady-state using the partial area function within WinNonlin.|Day 85 Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours after the AM dose|Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma concentration data for Apremilast.||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
134415|NCT00521339|Secondary|Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase|"A relapse was defined as a 50% loss of maximal American College of Rheumatoid (ACR) Score improvement in participants with psoriatic arthritis who achieved at least an ACR 20 score during the treatment phase.~Relapses were only captured prior to the prescription of concomitant psoriatic treatment."|Observational follow up phase; Days 168 to Day 196|This endpoint was not summarized since there were only 8 participants with psoriatic arthritis enrolled in the study and only 2 participants who achieved an ACR 20 response during the treatment phase.|||||
134416|NCT00521339|Secondary|Percent of Participants With Psoriatic Arthritis Who Achieved an American College of Rheumatology 20% Improvement (ACR-20) Response at Week 12|"A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last observation carried forward was used. Only a small percentage of participants had psoriatic arthritis.||percentage of participants|||Number
134417|NCT00521339|Secondary|Time to Relapse of Psoriasis (50% Loss of Maximal PASI Score Improvement in Participants Who Achieved at Least PASI-50 During the Treatment Phase) During the Observational Follow up Phase|Time to relapse of psoriasis (50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment phase) during the observational follow up phase was not analyzed. Time to relapse of psoriasis was defined as a 50% loss of maximal PASI score improvement in participants who achieved at least PASI-50 during the treatment or extension phase. The lesion on each area of the body was assessed for redness, thickness, and scaling.|28-day Observational Follow-up Phase; Days 168 to Day 196.|Time to relapse of psoriasis was not analyzed due to the small number of participants enrolled and who achieved PASI-50 and entered the observation follow-up phase.|||||
134418|NCT00521339|Secondary|Time to Achieve PASI-75 During Treatment Phase|Time to achieve PASI-75 during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-75 was not analyzed, due to the small number of participants enrolled and who achieved PASI-75.|||||
134419|NCT00521339|Secondary|Time to Clinically Relevant Response (Time to Achieve PASI-50) During Treatment Phase|Time to clinically relevant response (time to achieve PASI-50) during treatment phase was not analyzed. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.||Time to achieve PASI-50 was not analyzed since the study enrolled a small number of participants and the number of participants who achieved PASI-50 was even smaller.|||||
134420|NCT00521339|Secondary|Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) Involvement at Week 12|The BSA estimate was based on the palm area of the hand of the participant which equates to 1% of the total body surface area.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||Percent change in BSA||Standard Deviation|Mean
134421|NCT00521339|Secondary|Maximal PASI Response Documented for Each Participant During Treatment Phase|PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline to Week 12|Maximal PASI response was not analyzed since similar information was captured in change in psoriasis area severity Index (PASI) score at Day 85, which is week 12.|||||
134837|NCT00518284|Secondary|Decrease in Ankle Brachial Index (ABI) > 0.15|"The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15.~Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure."|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
134422|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-50 Score at Week 12|PASI -50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||percentage of participants||95% Confidence Interval|Number
134423|NCT00521339|Secondary|Percentage of Participants Who Achieved a PASI-75 Score at Week 12|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant.|Baseline to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.||percentage of participants||95% Confidence Interval|Number
134424|NCT00521339|Secondary|Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12|The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||percent change||Standard Deviation|Mean
134425|NCT00521339|Secondary|Percentage of Participants With at Least a 1 Point Reduction on 0 to 5 Point Scale From Baseline in Static Physician Global Assessment (sPGA) at Week 12|The static Physician’s Global Assessment (sPGA) rated the investigator’s overall clinical assessment of a participants plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Decreases in sPGA correspond to clinical improvement.|Baseline and Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication. Last Observation Carried Forward.||percentage of participants||95% Confidence Interval|Number
134426|NCT00521339|Primary|Treatment Emergent Adverse Events (TEAEs) During the Treatment Phase|"TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death.~Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event."|Week 0 to Week 12|Safety population consisted of all participants who were enrolled and received at least one dose of study medication.||participants|||Number
134427|NCT00521144|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR +PR|Every 6 weeks, assessed up to 30 days|Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.||participants|||Number
134428|NCT00521053|Secondary|Overall Survival|1-year survival|52 weeks|ITT participants||percentage of participants|||Number
134429|NCT00521053|Post-Hoc|Rate of Complete Response|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Complete Response Rate (CRR) = %CR.|52 weeks|ITT participants having all baseline disease injected with PV-10||percentage of participants||95% Confidence Interval|Number
135027|NCT00517075|Primary|Clinical Improvement of Negative Symptoms (Positive and Negative Syndrome Scale [PANSS] Negative Symptoms Subscale) Relative to Pre-treatment Baseline.||At baseline, every 2 weeks during rTMS sessions, and at monthly follow-up visits.|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
134431|NCT00521053|Secondary|Objective Response Rate of Untreated Bystander Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for designated, untreated cutaneous or subcutaneous bystander lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all bystander lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of bystander lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants having at least one uninjected dermal bystander lesion designated at baseline (some ITT participants did not have at least one bystander lesion).||percentage of participants||95% Confidence Interval|Number
134432|NCT00521053|Primary|Objective Response Rate (ORR) of PV-10 Treated Lesions|Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.|52 weeks|ITT participants||percentage of participants||95% Confidence Interval|Number
134433|NCT00521014|Primary|Progression-free Survival Rate|"after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as:~≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR~appearance of any new lesions"|up to 3 years|||years||Full Range|Mean
134434|NCT00520975|Other Pre-specified|VEGF Levels in Breast Tumor by Immunohistochemistry Assay (Tumor Sample Has Not Been Analyzed Yet, no Results Could be Reported)|Tissue sections from the primary or metastatic paraffin blocks were subjected to VEGF immunohistochemistry (IHC). The VEGF cytoplasmic staining intensity was evaluated semiquantitavely using a classification from 0 to 3, with 0 representing lack of staining, 1 = low staining intensity, 2 = intermediate staining intensity and 3 = strong staining intensity. The fraction of positively staining cells will be determined as well (0 = lack of staining, 1 ≤ 1% cell staining, 2 = 1 – 10% cell staining, 3 = 10 – 50% cell staining, 4 = 50 – 90% cells staining and 5 ≤ 90% cells staining) (48). Staining intensity score zero and fraction of positively staining cells of ≤ 1% (scores zero and 1) will be considered as absence of staining and therefore negative overexpression of VEGF.|assessed at baseline||||||
134435|NCT00520975|Other Pre-specified|Number of Circulating Tumor Cells at Baseline|Number of circulating tumor cells per 7.5mL blood were counted prior to starting protocol therapy|assessed at baseline prior to starting protocol therapy|Patients who had blood sample drawn at baseline prior to starting protocol therapy||number of cells per 7.5 mL blood||Full Range|Median
134436|NCT00520975|Other Pre-specified|Change in Level of Experiencing Side Effects Between Baseline and Cycle 6 Induction|Participants indicated their level of experiencing side effects across 1 item (Functional Assessment of Cancer Therapy [FACT] item G5) on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 4 with a higher score representing better quality of life (QOL).|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their level of experiencing side effects using FACT item G5 at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
134437|NCT00520975|Other Pre-specified|Change in Neurotoxicity Level Between Baseline and Cycle 6 Induction|Participants indicated their level of neurotoxicity symptoms across 4 items using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient ranged from 0 to 16 with higher scores representing fewer neurotoxic symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their neurotoxicity level using FACT/GOG-Ntx scale at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
134438|NCT00520975|Other Pre-specified|Change in FACT/NCCN Breast Symptom Index (FBSI) Between Baseline and Cycle 6 Induction|Participants indicated their level of breast symptoms across 8 items using the Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) FBSI scale, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient, ranged from 0 to 32 with higher scores representing fewer symptoms.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
134439|NCT00520975|Other Pre-specified|Change in Fatigue Level Between Baseline and Cycle 6 Induction|Fatigue level was measured using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue subscale. Participants indicated their level of fatigue across 13 items, each item on a 5-point Likert scale ranging from 0 (not at all) to 4(very much). Total score per patient was calculated by taking the reverse of each item (unless specified not to), taking the sum of those items, multiplying the sum by the number of items in the scale, and then dividing that number by the number of answered items. Total score ranged from 0 to 52 with higher scores representing less fatigue.|assessed at baseline and at cycle 6 induction prior to starting maintenance therapy|All patients who reported their fatigue level using FACIT Fatigue subscale at both baseline and cycle 6 induction||scores on a scale||Full Range|Median
134440|NCT00520975|Secondary|Number of Patients Experiencing Congestive Heart Failure|Clinical congestive heart failure (CHF) was assessed using Left Ventricular Ejection Fraction (LVEF) and symptom information via the Cardiac Toxicity Form as well as symptom information collected via the Adverse Event Form. Clinical CHF was defined as symptomatic decline in LVEF to below the lower limit of normal (LLN) or symptomatic diastolic dysfunction.|assessed every 3 months while on treatment and at 3 months post treatment|All patients who began protocol treatment||participants|||Number
134441|NCT00520975|Secondary|Overall Response Rate|Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|assessed at baseline, every 12 weeks while on treatment, then very 3 months if patient is <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years from study entry until disease progression|All randomized patients||proportion of participants||95% Confidence Interval|Number
142190|NCT00450619|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years, 5 months|||Participants|||Number
134442|NCT00520975|Secondary|Proportion of Progression-free at 6 Months|Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Proportion of progression-free at 6 months was calculated using the Kaplan-Meier method.|assessed at baseline, at 3 and 6 months after study entry|All randomized patients||proportion of participants||95% Confidence Interval|Number
134443|NCT00520975|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. Kaplan-Meier method was used to estimate the median OS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients||Months||95% Confidence Interval|Median
134444|NCT00520975|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as time from date of randomization to first disease progression, new second breast primaries, or to death from any cause, whichever occurred first, otherwise cases were censored at date last documented to be free of progression. Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the median PFS.|assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years|All randomized patients||Months||95% Confidence Interval|Median
134445|NCT00520936|Secondary|Pharmacogenomics - Measure the Response of Genes Related to Toxicity|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature.|baseline|The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here.||Correlation coefficient|||Number
134446|NCT00520936|Secondary|Number of Patients With Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug|AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator.|every cycle (up to 2 years and 7 months)|All treated participants.||Participants|||Number
134447|NCT00520936|Primary|Percentage of Participants With Overall Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100.|baseline to measured progressive disease (up to 1 year)|All treated participants.||Percentage of Participants|||Number
134448|NCT00520845|Other Pre-specified|Changes in Urinary PGE-M and Survival as Assessed by Immunohistochemistry||At 1 year|data is not available. no analysis done|||||
134449|NCT00520845|Other Pre-specified|Effect of Celecoxib on Urinary Metabolites of PGE2, PG12 and Thromboxane||At 1 year|data is not available. no analysis done|||||
134450|NCT00520845|Secondary|Time to Progression|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.||days||95% Confidence Interval|Median
134451|NCT00520845|Secondary|Overall Response Rate|Overall response rate is measured by complete response + partial response. Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On‐treatment date to date of disease progression (assessed at 6 weeks up to 2 years)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.||participants||95% Confidence Interval|Number
134452|NCT00520845|Primary|Median Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|2 years from date of registration|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.||days||95% Confidence Interval|Median
134453|NCT00520767|Secondary|Overall Hematologic Response Rate (OHR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.||||||
134454|NCT00520767|Secondary|Toxicity, Including Neurotoxicity||Day 1 of Each Cycle||||||
134455|NCT00520767|Secondary|Organ Response Rate (OrR)||Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.||||||
134456|NCT00520767|Secondary|Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire.||At the start of each cycle||||||
134457|NCT00520767|Secondary|Time to Treatment Failure||Day 1 of Each Cycle||||||
134458|NCT00520767|Secondary|Overall Survival||Day 1 of Each Cycle and every 12 weeks after last treatment cycle||||||
134459|NCT00520767|Primary|Complete Hematologic Response||Up to 12 months|Individuals evaluable for response||participants|Participants||Number
134460|NCT00520741|Secondary|Patient's Global Impression of Change (PGIC) From Baseline To Last Visit|"For the assessment of the Patient’s Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject’s functional status.The subject was asked to answer the following:~Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.)~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).||participants|||Number
134461|NCT00520741|Secondary|Clinical Global Impression of Change (CGIC) From Baseline To Last Visit|"For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject’s clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject’s functional status. He was asked the following:Please check the number that best describes the subject’s condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline; Last Visit (approximately 27 weeks)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).||participants|||Number
134462|NCT00520741|Secondary|Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)|Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.|Visit 9 - Visit 12 (approximately 10 weeks)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs).This subset of the FAS included subjects who entered the Maintenance Phase but who never achieved Lacosamide (LCM) monotherapy.||days||Full Range|Median
134463|NCT00520741|Secondary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period|"Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112:~Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis~Withdrawal due to AE with onset during the Maintenance Phase~Withdrew prematurely due to lack of efficacy during the Maintenance Phase~The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy.~The secondary analysis is only conducted on the Lacosamide 400 mg/day group."|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).||percentage of subjects|||Number
134464|NCT00520741|Secondary|Time to First Occurrence of Any Exit Event During The Maintenance Period|The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.|16 Weeks Maintenance Period (approximately 112 days)|The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs). In addition to being a member of FAS, subjects also met at least one of the exit criterion noted under the Primary Outcome Measure.||days||Full Range|Median
134465|NCT00520741|Primary|Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)|"Pre-defined exit criteria:~A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase~A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.~Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion~Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization~A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation~Status epilepticus, or new onset of serial/cluster seizures"|16 Weeks Maintenance Period (approximately 112 days)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (ie, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).~The primary analysis is only conducted on the Lacosamide 400 mg/day group."||percentage of subjects|||Number
134466|NCT00520676|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on safety population. This population includes all participants with non-squamous histology who received at least one dose of study drug. Participants were analysed according to treatments they actually received.||participants|||Number
135185|NCT00515463|Secondary|Basophils Change From Baseline at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
134467|NCT00520676|Secondary|Survival Without Grade 4 Toxicity|Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||participants||95% Confidence Interval|Median
134468|NCT00520676|Secondary|Survival Without Clinically Important Grade 3 or 4 Toxicity|Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least one dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
134469|NCT00520676|Other Pre-specified|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.||months||95% Confidence Interval|Median
134470|NCT00520676|Secondary|Percentage of Participants With Tumor Response (Response Rate)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on tumour response-qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.||percentage of participants||95% Confidence Interval|Number
134471|NCT00520676|Secondary|Progression-free Survival (PFS)|Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This set includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
134472|NCT00520676|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
134473|NCT00520676|Primary|Survival Without Grade 3 or 4 Toxicity|"Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.~Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact."|Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).|Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.||months||95% Confidence Interval|Median
134474|NCT00520572|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).|Baseline to 6 months|||Composite score||Standard Deviation|Mean
134475|NCT00520572|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 6 months’ treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).|Baseline to 6 months|||Composite score||Standard Deviation|Mean
135186|NCT00515463|Secondary|Basophils Change From Baseline at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
134478|NCT00520572|Primary|American College of Rheumatology 20 Response (ACR20) at 6 Months|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 6 months’ treatment|6 months|||Participants|||Number
134479|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined without malign lesions <=5mm.|within < 2 weeks after PET/MRI|lesion based (malignant lesions >5mm, n=98) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)||lesions|Participants||Number
134480|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)|PET positive lesions in patients with Gleason >6(3+3),n=43 were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative & positive predictive values were determined.|within < 2 weeks after PET/MRI|"lesion based (patients with Gleasons Score >6(3+3),n= 43) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38).~Gleason Grades: 1+2=well differentiated (rare), 3=moderately diff., 4=poorly diff., 5=undifferentiated~Gleason Score = histological primary grade + secondary grade (min=2,max=10)"||lesions|Participants||Number
134481|NCT00520546|Secondary|Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients|PET positive lesions (n=128) were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. Sensitivity, specificity, accuracy, negative and positive predictive values were determined.|within < 2 weeks after PET/MRI|Comparison of lesion based (128)imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients = 38).||lesions|Participants||Number
134482|NCT00520546|Primary|Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings|PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.|within < 2 weeks after PET/MRI|Comparison of imaging results (FEC-PET, MRI and PET/MRI) with postoperative histological findings (all patients).||participants|||Number
134483|NCT00519818|Secondary|17 Hydroxyprogesterone at 08.00 Hours||Cortef after one week compared with Chronocort after one month|||nmol/l||Standard Deviation|Mean
134484|NCT00519818|Primary|Chronocort vs. Cortef Cortisol Concentrations (AUC Over 24 Hours - Time Points 0,.5,1,1.5,2,3,4,5,6,7,8,10,10.5,11, 11.5,12,13,15,17,17.5,18,18.5,19,20,22,24 Post Dose).||Cortef after one week, Chronocort after one month|Per protocol||h*nmol/l||Standard Error|Mean
134485|NCT00519779|Secondary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score~The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||scores on a||Standard Error|Least Squares Mean
134486|NCT00519779|Primary|Stimulated ln(TNF-alpha)|log-transformed stimulated TNF-alpha|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||ln(pg/mL)||Standard Error|Least Squares Mean
134487|NCT00519779|Primary|Stimulated ln(IL-6)|"log-transformed stimulated IL-6~Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.~Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intent to treat||ln(pg/mL)||Standard Error|Least Squares Mean
134488|NCT00519779|Primary|Serum ln(TNF-a)|"log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)~All cytokine measurements (e.g., IL-6 and TNF-a, serum and stimulated) were analyzed across time; however, no stress effects were found. Therefore, all assessments post-supplementation were averaged (time points 3-6) and analyzed to determine whether fish oil supplementation had an effect. Pooling these 4 assessments provides a better estimate of an individual’s cytokine levels because single time point measurements can be affected by changes in exercise, alcohol consumption, or sleep in the preceding 24-48 hours."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||ln(pg/mL)||Standard Error|Least Squares Mean
134489|NCT00519779|Secondary|ln(Beck Anxiety Score)|log-transformed Beck anxiety score, min-max values - 0-4.1: higher means greater anxiety|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||units||Standard Error|Least Squares Mean
135187|NCT00515463|Secondary|Basophils Change From Baseline at Month 1|Laboratory hematology basophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
134490|NCT00519779|Primary|Serum ln(IL-6)|"log-transformed serum Interleukin-6 (IL-6)~Serum cytokine levels provide an assessment of systemic inflammation, the cytokine level circulating throughout the body. Higher levels are typically interrupted as worse unless an individual is acutely ill.~Stimulated cytokine production reflects the inflammatory cytokine production capacity of monocytes."|every 3 weeks for 3 months after initiating supplementation (outcome reported is the average outcome across all 4 time points)|intention to treat||ln(pg/mL)||Standard Error|Least Squares Mean
134491|NCT00519649|Secondary|Number of Participants Reporting Serious Adverse Events (SAE)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|After the challenge dose of HBV vaccine.|||participants|||Number
134492|NCT00519649|Secondary|Number of Participants Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after the challenge dose of HBV vaccine.|||participants|||Number
134493|NCT00519649|Secondary|Number of Participants Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache|During the 4-day follow-up period after the challenge dose of HBV vaccine.|||participants|||Number
134494|NCT00519649|Secondary|Number of Participants Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling|During the 4-day follow-up period after the challenge dose of HBV vaccine.|||participants|||Number
134495|NCT00519649|Secondary|Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL|Before challenge dose of HBV vaccine|Analysis was performed on subjects from the According-to-Protocol cohort for analysis of antibody persistence for whom serological results were available at pre-HBV vaccine challenge blood sampling time point||participants|||Number
134496|NCT00519649|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value|Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)|One month after the challenge dose of HBV vaccine|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity||participants|||Number
134497|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At the screening visit, before and after infusions (Days 1 to 5), and at the completion visit (Week 25)|The SDS comprised all treated patients.||participants|||Number
134498|NCT00520494|Secondary|Number of Patients With Clinically Relevant Changes in Routine Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters, and were assessed at screening, Week 12 (hematology and serum chemistry) and at the completion visit (approximately Week 25).|At Weeks 12 and 25|The SDS comprised all treated patients.||participants|||Number
134499|NCT00520494|Secondary|Rate of Local Reactions by Severity and Relatedness|"The rate was the number of local reactions over the number of infusions administered.~Local reactions included:~infusion site: erythema, pain, pruritus, rash, reaction, swelling;~injection site: bruising, erythema, irritation, pruritus, swelling;~edema peripheral;~tenderness;~erythema;~pruritus; and~skin swelling.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.||local reactions per infusion|Participants||Number
134500|NCT00520494|Secondary|Number of Patients With Local Reactions by Severity and Relatedness|"Local reactions included: infusion site erythema, infusion site pain, infusion site pruritus, infusion site rash, infusion site reaction, infusion site swelling, injection site bruising, injection site erythema, injection site irritation, injection site pruritus, injection site swelling, edema peripheral, tenderness, erythema, pruritus, and skin swelling.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.||participants|||Number
134501|NCT00520494|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered.~Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The SDS comprised all treated patients.||AEs per infusion|Participants||Number
134502|NCT00520494|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Mild AE: Did not interfere with activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.~Not related: Explained by factors not involving the drug, no temporal relationship; Possibly related: Occurred within a reasonable time of administration, could also be explained by concurrent disease or other drugs; Probably related: Compelling temporal relationship, could not be explained concurrent disease/other drugs; Related AE: Compelling temporal relationship, known/suspected response to the drug confirmed by improvement on stopping."|For the duration of the study, up to approximately 25 weeks|The Safety data set (SDS) comprised all treated patients.||participants|||Number
134503|NCT00520494|Secondary|Quality of Life as Measured by the Child Health Questionnaire Parent Form-50 (CHQ-PF50; Age ≤ 13 Years)|The CHQ-PF50 is a 50-item questionnaire that measures generic health concepts and is suitable for patients younger than 14 years of age. The questions are grouped into 15 domains: global health, physical functioning, role/social limitations - emotional/behavioral, role/social limitations - physical, bodily pain, behavior, global behavior, mental health, self esteem, general health perceptions, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the CHQ-PF50 questionnaire were available.||units on a scale||Standard Deviation|Mean
134504|NCT00520494|Secondary|Quality of Life as Measured by the Adapted Short Form-36 Health Survey (SF-36; Age ≥ 14 Years)|The SF-36 is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At study completion, approximately Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set), and for which responses to the SF-36 questionnaire were available.||units on a scale||Standard Deviation|Mean
134505|NCT00520494|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Number of patients. Medications were classified as antibiotics according to the anatomic therapeutic chemical code.|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||participants|||Number
134506|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.||mg/L||Standard Deviation|Mean
134507|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against H. Influenzae Type B and S. Pneumoniae On Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.||mg/L||Standard Deviation|Mean
134508|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 specific IgG results were available.||IU/mL||Standard Deviation|Mean
134509|NCT00520494|Primary|Proportion of Patients Achieving Immunoglobulin G (IgG) Levels ≥ 5 g/L on Day 12||On Day 12|The intention-to-treat (ITT) data set comprised all patients who were treated with the study drug and completed Day 12.||proportion of patients||95% Confidence Interval|Number
134510|NCT00520494|Secondary|Serum Concentrations of Specific IgGs Against Cytomegalovirus, Tetanus, and Measles on Day 12||On Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Day 12 specific IgG results were available.||IU/mL||Standard Deviation|Mean
134511|NCT00520494|Secondary|Total Serum IgG Trough Levels at Week 25||At Week 25|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which Week 25 total serum IgG results were available.||g/L||Standard Deviation|Mean
134512|NCT00520494|Secondary|Total Serum IgG Trough Levels on Day 12||On Day 12|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||g/L||Standard Deviation|Mean
134513|NCT00520494|Secondary|Overall Rate of Infections|"Annualized rate of any infection. The annualized rate was based on the total number of infections and the total number of patient study days for all patients in the specified analysis population and adjusted to 365 days.~Infections were classified as all AEs with the system organ class infections and infestations."|For the duration of the study, up to approximately 25 weeks|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||infections per patient year|Participants|95% Confidence Interval|Number
134514|NCT00520494|Secondary|IgG Increase (Change From Baseline) on Day 12||Baseline to Day 12|The analysis population comprised all patients who were treated with the study drug and completed Day 12 (the ITT data set) and for which IgG results, as required for the analysis, were available.||g/L||Standard Deviation|Mean
134515|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 26||On Day 26|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||proportion of participants||95% Confidence Interval|Number
134516|NCT00520494|Secondary|Proportion of Patients Achieving IgG Levels ≥ 5 g/L on Day 19||On Day 19|The ITT data set comprised all patients who were treated with the study drug and completed Day 12.||proportion of participants||95% Confidence Interval|Number
134517|NCT00520468|Primary|Number of Participants With Response|Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response.|Response evaluation within first 3 months from start of therapy, then every 3 to 6 months|All treated patients on study included in analysis.||participants|||Number
134518|NCT00520403|Primary|PFS - Time to Event|PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method|Days 0, 91, 182, 273, 365, 456, and 547|ITT population.||days||Standard Error|Median
134519|NCT00520403|Secondary|Overall Survival (OS)|OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.|Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)|Two of 25 participants died during the course of the study, thus, median overall survival could not be analyzed.||weeks||Full Range|Median
135244|NCT00515463|Secondary|Potassium Change From Baseline at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
134520|NCT00520403|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.|Baseline and Cycles 3, 6, 9, 13, and 17|ITT Population; missing data were imputed using the last observation carried forward (LOCF) technique. Number (n) equals (=) number of participants assessed at each specific visit.||percentage of participants|||Number
134521|NCT00520403|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.|Days 0, 91, 182, 273, 365, 456, and 547|Intent-to-treat (ITT) population: all participants, even those who withdrew from the study prematurely, who received at least 1 dose of study medication and for whom the primary efficacy variable was measured at least once during the time when the participant received study medication.||percentage of participants|||Number
134522|NCT00520351|Primary|Subjective Comfort Rating|Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.|2 weeks|||Units on a scale||95% Confidence Interval|Mean
134523|NCT00520351|Primary|In-vivo Wettability|Pre-lens non-invasive tear breakup time|2 weeks|||Seconds||95% Confidence Interval|Least Squares Mean
134524|NCT00520351|Primary|Low Contrast Visual Acuity|"Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.~10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks|Analysis was per protocol||logMAR||Standard Deviation|Mean
134525|NCT00520351|Primary|High Contrast Visual Acuity|"High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.~10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."|2 weeks|||logMAR||Standard Deviation|Mean
134526|NCT00520234|Secondary|Subjects With 1 or More Serious Drug-related Adverse Event(s)||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.||participants|||Number
134527|NCT00520234|Secondary|Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event||Up to 14 days after end of therapy|Safety population, defined as all subjects who received at least one dose of study drug.||participants|||Number
134528|NCT00520234|Secondary|Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.||Hospital discharge||||||
134529|NCT00520234|Secondary|Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.||Within 14 days after end of therapy||||||
134530|NCT00520234|Secondary|Time to Beta Glucan Negativity in Pre-emptive Phase.||Within 14 days after end of therapy||||||
134531|NCT00520234|Secondary|Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.||Within 7 days after end of therapy||||||
134532|NCT00520234|Secondary|Time to Development of Proven or Probable Invasive Candidiasis||Within 7 days after end of therapy||||||
134533|NCT00520234|Secondary|Initiation of Other Antifungals||Within 7 days after end of therapy||||||
134534|NCT00520234|Secondary|All Cause Mortality||Within 7 days of end of therapy||||||
134535|NCT00520234|Secondary|Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.||Within 7 days of end of therapy||||||
134536|NCT00520234|Primary|Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.|Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.|Within 7 days after end of therapy|Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis.||percent of participants|||Number
134537|NCT00520013|Secondary|Consolidation Objective Response Rate|Consolidation objective response (OR) was based on RECIST 1.0 criteria with OR defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. If CA125 disease then OR based on Rustin criteria is a 50% decrease in serum CA125 level from two initially elevated samples confirmed by a 4th sample.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year.|The analysis dataset is comprised of all patient who started consolidation treatment.||proportion of patients||95% Confidence Interval|Number
134538|NCT00520013|Primary|Consolidation Treatment-related Toxicity Rate|Consolidation treatment-related toxicity rates based on CTCAEv3 were defined as rates of maximum grade 3 or higher toxicity events with attribution possible, probable or definite occurring during consolidation treatment and up to 30 days post-treatment.|Assessed every cycle during consolidation treatment and up to 30 days post-treatment. Per protocol, consolidation treatment was a fixed duration of 1 year.|The analysis dataset is comprised of patients who were randomized to consolidation treatment.||percentage of participants||95% Confidence Interval|Number
134548|NCT00519623|Secondary|Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients|Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site.|Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal||11/2010||||
135188|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
134539|NCT00520013|Primary|Consolidation Progression-Free Survival|Consolidation PFS based on the Kaplan-Meier method was defined as the time from the first day of consolidation therapy to documented disease progression (PD) or disease-specific death. Based on RECIST 1.1, radiographic PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning consolidation, the appearence of one or more new lesions and/or unequivocal progression of existing non-target lesions. Based on Rustin criteria, serlogic PD was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to >/= 2xULN with either event documented on 2 occasions. Patients who were event-free were censored at the date of their last disease evaluation.|Assessments occurred every cycle (serologic) and every 3 cycles (radiologic) on consolidation treatment. Pts were allowed on consolidation therapy for up to 1 year and upon treatment discontinuation were followed for another year.|The analysis dataset is comprised of patients randomized to consolidation treatment.||months||95% Confidence Interval|Median
134540|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist|"Subjects assessed preference over gentleness of mist for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
134541|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use|"Subjects assessed preference over ease of use for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
134542|NCT00519636|Secondary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat|"Subjects assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
134543|NCT00519636|Secondary|Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
134544|NCT00519636|Secondary|Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population. A subject in the FP/FF group had no baseline daytime TNSS; however, does have a baseline nighttime TNSS, that value serves as the baseline 24-hour TNSS. Therefore there are 90 24-hour & nighttime TNSS observations available in the FP/FF group, but only 89 daytime TNSS observations.||Scores on a scale||Standard Error|Mean
134545|NCT00519636|Primary|Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor|"Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering I prefer product 1 for spray used during Treatment Period 1 or I prefer product 2 for spray used during Treatment Period 2. Subject could also choose I have no preference."|End of Crossover Period (Day 22)|Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.||Participants|||Number
134546|NCT00519636|Primary|Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos|Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.|Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)|Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.||Scores on a scale||Standard Error|Mean
134547|NCT00519623|Primary|Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.|Glucose infusion rates were adjusted every 10 minutes as necessary|||mg/kg/min||Standard Error|Mean
135189|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
134549|NCT00519623|Primary|Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)|Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.|Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours|Number of subjects completed||uU/mL||Standard Error|Mean
134550|NCT00519532|Secondary|Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)|"The change in number of nocturias was used to evaluate improvements in sleep disorders.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).||Nocturias||Standard Deviation|Mean
134551|NCT00519532|Secondary|Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)|"Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
134552|NCT00519532|Primary|Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)|"The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.~Baseline is defined as Visit 2 of previous double- blind trial SP889."|Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
134553|NCT00519532|Primary|Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.~Baseline is defined as first titration visit (T1) of SP915."|Baseline (baseline SP915) and week 13 (End of maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
134554|NCT00519376|Secondary|Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The Time to maximum plasma concentration (Tmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed||Hours||Full Range|Median
134555|NCT00519376|Secondary|Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The maximum observed plasma concentration (Cmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Day 1 of each treatment period (up to Study Day 54)|PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
134556|NCT00519376|Secondary|AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444|Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009 using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. AUC defined as area under the plasma concentration curve from time zero to the last quantifiable concentration (AUC(0-t)), and up to 1 hour post-dose (AUC(0-1)) were determined by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Pharmacokinetic (PK) Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed||picograms.Hour/milliliter (pg.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
134557|NCT00519376|Secondary|Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium|Blood samples were collected for the measurement of potassium and glucose at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3 and 4 hours post-dose on Day 1of the each treatment period. Whole blood samples (approximately 1.0 milliliter [mL]) was analysed for potassium and glucose using the i-STAT1 portable chemical analyser. The i-STAT1 system is an analyser designed for point of care testing and employs a hand-held chemistry analyzer and disposable cartridges, which in the configuration tested, are capable of measuring potassium, glucose, blood gases, electrolytes, metabolites and coagulation. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. The data is presented as adjusted mean of WM and maximum (max) glucose /minimum (min) potassium.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Millimoles per liter (mmol/L)||Standard Error|Mean
134566|NCT00519376|Primary|Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
134558|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure|Blood pressure (BP) measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. SBP and DBP were recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3, 4 and 6 hours post-dose on Day 1of the each treatment period. SBP and DBP recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum SBP and DBP.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Millimeters of mercury||Standard Error|Mean
134559|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate|Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. Heart rate was recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1, 2, 3, 4 and 6 hours post-dose on Day 1of each treatment period. Heart rate recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum heart rate.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Beats per minute||Standard Error|Mean
134560|NCT00519376|Secondary|Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the 12-lead ECG. QTcB is the QT interval corrected for heart rate using Bazett's formula; QTcF is the QT interval corrected for heart rate using Fridericia's formula. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. QTcB and QTcF recorded at 20 minutes, 45 minutes, 1, 2, 3, and 4 hours post-dose on Day 1 of each treatment period were used for analysis. The data is presented as the adjusted means of WM and maximum QTc(B) and QTc(F).|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Milliseconds (msec)||Standard Error|Mean
134561|NCT00519376|Secondary|Mean FEV1 Over 23 and 24 Hours After Dosing|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. The data is presented as adjusted mean of the FEV1 values over 23 and 24 hours after dosing. Changed in trough FEV1 will be analysed using a model with baseline, treatment, period, as fixed effects .|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the indicated time points were assessed.||Liters||Standard Error|Mean
134562|NCT00519376|Primary|Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period|ECG parameters [PR, QRS, RR, QT (uncorrected), QTcB (QT corrected by Bazett's formula) and QTcF (QT corrected by Fridericia's formula) intervals] were measured at Baseline and over the post-dose 24h period at the following scheduled time points: 20 minutes (min), 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline was defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|PP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PP Population.||milliseconds (msec)||Standard Deviation|Mean
134563|NCT00519376|Primary|Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period|Heart rate (HR) was measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Per Protocol (PP) Population: all participants included in the All Subjects population excluding a participant deemed not to have heart rate or other ECG parameters deemed suitable for evaluation. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).||Beats per minute(bpm)||Standard Deviation|Mean
134564|NCT00519376|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period|SBP and DBP were measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1h, 2h, 3h, 4h, 6h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
134565|NCT00519376|Primary|Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of c-reactive protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Milligrams per liter (Mg/L)||Standard Deviation|Mean
134657|NCT00518882|Secondary|Change in Apolipoprotein B at Week 26|Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||g/L||Standard Error|Least Squares Mean
142191|NCT00450619|Primary|Progression Free Survival (PFS)|PFS is defined as the time to progress or die after the start of the therapy.|4 months|||months||95% Confidence Interval|Median
134567|NCT00519376|Primary|Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of cholesterol, chloride, potassium, sodium, triglycerides, and urea at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
134568|NCT00519376|Primary|Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter||Standard Deviation|Mean
134569|NCT00519376|Primary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
134570|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCH at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 picograms (pg) per cell||Standard Deviation|Mean
134571|NCT00519376|Primary|Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
134572|NCT00519376|Primary|Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Proportion of 1.0||Standard Deviation|Mean
134573|NCT00519376|Primary|Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^12 cells per liter (TI/L)||Standard Deviation|Mean
134574|NCT00519376|Primary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Grams per liter (g/L)||Standard Deviation|Mean
135028|NCT00517010|Secondary|1. Change in BCVA From Baseline|change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline|24 months|||change in number of letters||Standard Deviation|Mean
134575|NCT00519376|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell (WBC) count at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline and Day 1 of each treatment period (up to Study Day 54)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||10^9 cells per liter (GI/L)||Standard Deviation|Mean
134576|NCT00519376|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)|All Subjects Population: all participants who received at least one dose of study medication||Participants|||Number
134577|NCT00519285|Secondary|Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept|"Serum for detection of anti-drug antibodies (ADA) was collected in patients treated in selected centers only. Samples were analyzed using a titer-based, bridging immunoassay developed and validated to detect ADAs in human serum.~Samples with positive antibody levels were further analyzed using a validated, non-quantitative ligand binding assay to detect neutralizing antibodies Ab).~A participant was considered to have positive antibody levels if antibodies were detected above the quantification limits."|Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug|The analysis was performed on the safety population evaluable for immunogenicity (i.e. exposed to aflibercept with serum samples evaluable for immunogenicity).||participants|||Number
134578|NCT00519285|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study.~AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0)."|From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days|The analysis was performed on the safety population (i.e. all randomized and treated participants according to the treatment actually received). Six participants in the Placebo group who received at least one dose of aflibercept in error were considered in the Aflibercept group.||participants|||Number
134579|NCT00519285|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life|"Functional Assessment of Cancer Therapy-Prostate (FACT-P) is a 39-item participant questionnaire that measures the concerns of patients with prostate cancer. It consists of 5 subscales assessing physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate-specific concerns.~FACT-P total score is the sum of the 5 subscores. It ranges from 0 to 156 with higher score indicating better quality of life."|Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first|The analysis was performed on the ITT population evaluable for Health related quality of life (i.e. with baseline and at least one post-baseline evaluable FACT-P questionnaire).||units on a scale||Standard Deviation|Mean
134580|NCT00519285|Secondary|Pain Response Rate|Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response.|Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first|The analysis was performed in the ITT population evaluable for pain response (i.e. stable analgesia at baseline and, baseline PPI ≥2 and/or baseline AS ≥10 points).||percentage of participants||95% Confidence Interval|Number
134581|NCT00519285|Secondary|Pain Progression-free Survival Time|"Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores.~Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first.~The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population evaluable for pain progression (i.e. with no pain or with stable pain at baseline).~At the cut-off date, pain progression or death had occurred in 507 participants, 263 in the Placebo group and 244 in the Aflibercept group."||months||95% Confidence Interval|Median
134658|NCT00518882|Secondary|Change in Free Fatty Acid at Week 78|Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134582|NCT00519285|Secondary|Prostate Specific Antigen Progression-free Survival Time|"Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response.~PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first.~The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed in the ITT population evaluable for PSA progression (i.e. with an evaluable baseline PSA).~At the cut-off date, PSA progression or death had occurred in 1138 participants, 571 in the Placebo group and 567 in the Aflibercept group."||months||95% Confidence Interval|Median
134583|NCT00519285|Secondary|Tumor Response Rate in Participants With Measurable Disease|Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0.|Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for tumor response (i.e. received at least one dose of study drugs (aflibercept/placebo or docetaxel), had no important deviations to protocol and was evaluable for response as per RECIST version 1.0).||percentage of participants||95% Confidence Interval|Number
134584|NCT00519285|Secondary|Progression Free Survival Time|"Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE).~Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.~The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.~At the cut-off date, disease progression or death had occurred in 1184 participants, 592 in each treatment group."||months||95% Confidence Interval|Median
134585|NCT00519285|Secondary|Time to Skeletal Related Events|"Skeletal Related Events (SRE) included pathological fractures and/or spinal cord compression, need for bone irradiation, including radioisotopes or bone surgery, change in antineoplastic therapy to treat bone pain.~Time to SRE was defined as the time from the date of randomization to the date of occurence of the first event defining a SRE or death due to any cause, whichever occurred first.~The median time to SRE and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of SRE, the participant was censored at the last date he/she was known to be alive or the study cut-off date, whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the ITT population.~At the cut-off date, SRE or death had occurred in 1013 participants, 516 in the Placebo group and 497 in the Aflibercept group."||months||95% Confidence Interval|Median
134586|NCT00519285|Secondary|Prostate Specific Antigen Response Rate|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response.|Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first|The analysis was performed on the ITT population evaluable for PSA response (i.e. with a baseline PSA ≥10 ng/mL).||percentage of participants||95% Confidence Interval|Number
134587|NCT00519285|Primary|Overall Survival Time|"Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.~The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier."|From randomization up to the cut-off date (median follow-up of 35.4 months)|"The analysis was performed on the Intent-to-treat (ITT) population (i.e all randomized participants according to the treatment assigned regardless of the drug actually received).~At the cut-off date, 873 deaths had occurred, 445 in the Placebo group and 428 in the Aflibercept group."||months||95% Confidence Interval|Median
134588|NCT00519194|Primary|Freedom From Atrial Fibrillation in the Absence of Any AF Therapies|Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.|6 months|||participants|||Number
134589|NCT00519090|Secondary|Durable Complete Cytogenetic Response Rate|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|24 months|The trial was terminated early, so only 6 patients were enrolled.||percent of participants|||Number
134590|NCT00519090|Primary|Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib|Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.|12 months|||percent of participants|||Number
134591|NCT00519077|Secondary|Median Progression-free Survival Time|Progression-free survival (PFS) is the number of months during and after Gefitinib treatment during which the cancer did not get worse (progress) as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Progressive disease is associated with at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. All patients developed progressive disease or died during the 9-month observation period.|9 months|||months||95% Confidence Interval|Median
134699|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134592|NCT00519077|Primary|Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates|"The proportion of subjects that responded [complete (CR) or partial response (PR)], had stable disease (SD), or progressive disease (PD) as defined by the Response Evaluation Criteria In Solid Tumors (RECIST)~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|8 weeks|Eight patients were not assessable for response, six of them died prior to the evaluation of response. For the purpose of the analysis these patients were classified as having disease progression in response to therapy.||percentage of participants|||Number
134593|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of Sleepiness."|Baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
134594|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of Sleepiness."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
134595|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of Sleepiness."|Baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ES Symptom Rating Form at Baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
134596|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks|"Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0=no problem at all 10=as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of Sleepiness."|Baseline and 2 weeks|Full analysis set defined as subjects who completed the ES Symptom Rating form at baseline and 2 weeks||Units on a scale||Standard Error|Least Squares Mean
134597|NCT00518986|Secondary|Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)|"The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of Sleepiness."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
134598|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks."|baseline and 12 weeks following start of study drug administration|Full analysis set defined as subjects who completed MOS-CF6 at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
134599|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks."|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
134600|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks."|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
134601|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks."|baseline and 2 weeks|Full analysis set defined as subjects who completed the MOS-CF6 at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
134602|NCT00518986|Secondary|Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)|"The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from none of the time to all of the time. The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to Endpoint (12 weeks or last observation after baseline)."|Baseline and Endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
134603|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.|12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 12 weeks||Participants|||Number
134604|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.|8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 8 weeks||Participants|||Number
134605|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.|4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at 4 weeks||Participants|||Number
134606|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.|2 weeks following start of study drug administration|Full analysis set defined as subject who completed the FOSQ at 2 weeks||Participants|||Number
134607|NCT00518986|Secondary|Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.|Endpoint (week 12 or last observation after baseline)|Full analysis set defined as subjects with at least one observation after baseline||Participants|||Number
134608|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.|baseline and 12 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
135029|NCT00517010|Primary|Incidence and Severity of Ocular Adverse Events|Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.|24 months|||number of adverse events|||Number
134609|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.|baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
134610|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.|baseline and 4 weeks following start of study drug administration|Full analysis set defined as subjects who completed the FOSQ at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
134611|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.|baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed FOSQ at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
134612|NCT00518986|Secondary|Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)|The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.|Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
134613|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 12 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
134614|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
134615|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
134616|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
134617|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.|Baseline and at endpoint (12 weeks or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
134618|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.|12 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 12 weeks||Participants|||Number
134619|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.|8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at 8 weeks||Participants|||Number
134620|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.|4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 4 weeks||Participants|||Number
134621|NCT00518986|Secondary|Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.|2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at 2 weeks||Participants|||Number
134622|NCT00518986|Secondary|Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.|12 weeks after start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had at least one observation after baseline||Participants|||Number
134623|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.|12 weeks|||Units on a scale||Standard Error|Least Squares Mean
134624|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed the BFI at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
134625|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
134626|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who completed BFI at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
134627|NCT00518986|Secondary|Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).|Baseline and 12 weeks or last observation after baseline|Full analysis set defined as subjects with at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
134628|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.|Baseline and 12 weeks after start of study drug administration|||Units on a scale||Standard Error|Least Squares Mean
134629|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.|Baseline and 8 weeks after start of study drug administration|||Units on a scale||Standard Error|Least Squares Mean
134630|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
134631|NCT00518986|Secondary|Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.|Baseline and 2 weeks after start of study drug administration|Full analysis set defined as subjects who had completed BFI at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
134632|NCT00518986|Secondary|Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score|The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.|Baseline and 12 weeks following start of study drug administration or last recorded observation|Full analysis set defined as subjects with at least one BFI assessment after baseline||Units on a scale||Standard Error|Least Squares Mean
134633|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.|12 weeks|Full analysis set defined as subjects who completed the ESS at 12 weeks||Participants|||Number
134634|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.|8 weeks|Full analysis set defined as subjects who completed ESS at 8 weeks||Participants|||Number
134635|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.|4 weeks|Full analysis set defined as number of subjects who completed ESS at 4 weeks||Participants|||Number
134636|NCT00518986|Secondary|Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.|2 weeks|Full analysis set defined as the number of subjects who completed the ESS at 2 weeks||Participants|||Number
134637|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 12 weeks are summarized.|12 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed ESS at Baseline and at 12 weeks||Units on a scale||Standard Error|Least Squares Mean
134638|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 8 weeks are summarized.|Baseline and 8 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at Baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
134639|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to 4 weeks are summarized.|Baseline and 4 weeks after start of study drug administration|Full analysis set defined as subjects who completed ESS at baseline and at Week 4||Units on a scale||Standard Error|Least Squares Mean
134640|NCT00518986|Secondary|Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks|ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to two weeks are summarized.|Baseline and 2 weeks following start of study drug administration|Full analysis set defined as subjects who completed the ESS at baseline and at 2 weeks||Unit on a scale||Standard Error|Least Squares Mean
134641|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.|12 weeks after starting study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 12 weeks||Participants|||Number
134642|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.|8 weeks after start of study drug treatment|Full analysis set defined as subjects who were assessed by CGI-C at 8 weeks||Participants|||Number
134643|NCT00518986|Secondary|Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.|4 weeks after start of treatment|Full analysis set defined as subjects who were assessed by CGI-C at 4 weeks.||Participants|||Number
134644|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 12 Weeks|The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.|12 weeks after beginning treatment|Full analysis set defined as subjects assessed with CGI-C at week 12||Participants|||Number
134645|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 8 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 8 weeks were assessed."|8 weeks after beginning study drug treatment|Full analysis set defined as subjects assessed by CGI-C at 8 weeks||Participants|||Number
134646|NCT00518986|Secondary|Clinical Global Impression of Change (CGI-C) at 4 Weeks|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) at 4 weeks were assessed."|4 weeks after beginning study drug treatment|Full analysis set defined as subjects who were assessed with CGI-C at 4 weeks||Participants|||Number
134726|NCT00518622|Primary|Safety and Tolerability of MK7009|Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication|14 days after completion of study therapy|All treated patients are included in the safety analysis.||Participants|||Number
134647|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had measurements of MWT at baseline and 12 weeks.||Minutes||Standard Error|Least Squares Mean
134648|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 8 weeks following start of study drug administration|Full analysis set defined as subjects with MWT measure at 8 weeks and baseline||Minutes||Standard Error|Least Squares Mean
134649|NCT00518986|Secondary|Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.|baseline and 4 weeks|Full analysis set defined as subjects who had MWT measurement at baseline and at 4 weeks||Minutes||Standard Error|Least Squares Mean
134650|NCT00518986|Secondary|Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)|For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set defined as subjects who had at least one assessment of ESS after baseline||Units on a scale||Standard Error|Least Squares Mean
134651|NCT00518986|Primary|Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)|"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) were assessed."|12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or CGI-C after baseline.||Participants|||Number
134652|NCT00518986|Primary|Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)|MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.|Baseline and 12 weeks (or last observation after baseline)|Full analysis set which includes subjects who had at least 1 measurement of MWT or Clinical Global Impression of Change (CGI-C) after baseline.||Minutes||Standard Deviation|Mean
134653|NCT00518882|Secondary|Hypoglyceamic Episodes, Weeks 26-78|Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 26-78|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.||episodes|||Number
134654|NCT00518882|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The safety analysis set is all subjects who had been exposed to at least one dose of the study products.||episodes|||Number
134655|NCT00518882|Secondary|Change in Apolipoprotein B at Week 78|Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||g/L||Standard Deviation|Mean
134656|NCT00518882|Secondary|Change in Apolipoprotein B, Weeks 26-78|Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||g/L||Standard Deviation|Mean
134659|NCT00518882|Secondary|Change in Free Fatty Acid, Weeks 26-78|Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134660|NCT00518882|Secondary|Change in Free Fatty Acid at Week 26|Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134661|NCT00518882|Secondary|Change in Triglyceride at Week 78|Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134662|NCT00518882|Secondary|Change in Triglyceride, Weeks 26-78|Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134663|NCT00518882|Secondary|Change in Triglyceride at Week 26|Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134664|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 78|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134665|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol, Weeks 26-78|Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134666|NCT00518882|Secondary|Change in High-density Lipoprotein-cholesterol at Week 26|Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134667|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134668|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134669|NCT00518882|Secondary|Change in Very Low-density Lipoprotein-cholesterol at Week 26|Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134670|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 78|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134671|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol, Weeks 26-78|Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134672|NCT00518882|Secondary|Change in Low-density Lipoprotein-cholesterol at Week 26|Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134673|NCT00518882|Secondary|Change in Total Cholesterol at Week 78|Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.||mmol/L||Standard Deviation|Mean
134674|NCT00518882|Secondary|Change in Total Cholesterol, Weeks 26-78|Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.||mmol/L||Standard Deviation|Mean
134675|NCT00518882|Secondary|Change in Total Cholesterol at Week 26|Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134676|NCT00518882|Secondary|Change in Beta-cell Function at Week 78|"Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point (%point)||Standard Deviation|Mean
134677|NCT00518882|Secondary|Change in Beta-cell Function, Weeks 26-78|"Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point (%point)||Standard Deviation|Mean
134678|NCT00518882|Secondary|Change in Beta-cell Function at Week 26|"Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5)."|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||percentage point (%point)||Standard Error|Least Squares Mean
134679|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134680|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134681|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134682|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134683|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134684|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134685|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134686|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0. week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134687|NCT00518882|Secondary|Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134688|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134689|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134690|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134691|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78|Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134692|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78|Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134693|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78|Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134694|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26|Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134695|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26|Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134696|NCT00518882|Secondary|Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26|Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||mmol/L||Standard Error|Least Squares Mean
134697|NCT00518882|Secondary|Change in Fasting Plasma Glucose at Week 78|Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134698|NCT00518882|Secondary|Change in Fasting Plasma Glucose, Weeks 26-78|Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||mmol/L||Standard Deviation|Mean
134700|NCT00518882|Secondary|Change in Body Weight at Week 78|Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||kg||Standard Deviation|Mean
134701|NCT00518882|Secondary|Change in Body Weight, Weeks 26-78|Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||kg||Standard Deviation|Mean
134702|NCT00518882|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||kg||Standard Error|Least Squares Mean
134703|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage (%) of subjects|||Number
134704|NCT00518882|Secondary|Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26|Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||percentage (%) of subjects|||Number
134705|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c) at Week 78|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 0, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point of total HbA1c||Standard Deviation|Mean
134706|NCT00518882|Secondary|Change in Glycosylated A1c (HbA1c), Weeks 26-78|Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)|week 26, week 78|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.||percentage point of total HbA1c||Standard Deviation|Mean
134707|NCT00518882|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.||percentage point of total HbA1c||Standard Error|Least Squares Mean
134708|NCT00518713|Other Pre-specified|Percent Reduction of Total (Drop and Non-Drop) Seizures.|This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.|4-week baseline period and 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
134709|NCT00518713|Other Pre-specified|Percent Reduction in the Number of Non-drop Seizures.|This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.|4-week baseline period and the 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
134710|NCT00518713|Secondary|Parent/Caregiver Global Evaluations of the Patient’s Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who had a baseline and Week 15 parent/caregiver global evaluations were analyzed.||participants|||Number
134711|NCT00518713|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms.|"The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 15|Those patients in the MITT population who completed a Physician Global Evaluation at Week 15.||participants|||Number
134712|NCT00518713|Secondary|Tolerance|Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.|4-week baseline period and first 4/first 8 weeks of the maintenance period|MITT||Participants|||Number
134713|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period|||Percent Responders|||Number
135030|NCT00516919|Primary|Participant BMI|Body Mass Index (BMI)|4 months and 6 month follow-up|Data for all randomized participants were included. In the event of dropout or missing data, baseline values were used.||kg/m^2||Standard Deviation|Mean
134714|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period|||Percent Responders|||Number
134715|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT||Percent of responders|||Number
134716|NCT00518713|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 12-week maintenance period|||Percent of responders|||Number
134717|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the last 4 weeks of the 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
134718|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the middle 4 weeks of the 12-week maintenance period|||Percent reduction||Full Range|Least Squares Mean
134719|NCT00518713|Secondary|Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the first 4 weeks of the 12-week maintenance period|MITT population||Percent reduction||Full Range|Least Squares Mean
134720|NCT00518713|Primary|Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 12-week maintenance period|Modified Intent-to-Treat (MITT) population||Percent Reduction||Full Range|Least Squares Mean
134721|NCT00518687|Secondary|Number of Participants With Surgical-site Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination||participants|||Number
134722|NCT00518687|Secondary|Number of Participants With Invasive Staphylococcus Aureus Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination||participants|||Number
134723|NCT00518687|Primary|Incidence Rate of Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.|Up to 360 days after surgery|The population analyzed included all vaccinated participants with follow-up results||Events per 100 person-years|||Number
134724|NCT00518687|Primary|Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection|Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.|Up to 90 days after surgery|The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination||participants|||Number
134725|NCT00518622|Primary|Antiviral Activity of MK7009|Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8|Baseline and Day 8|Per-protocol population (defined as the study participants that completed the study as defined by the protocol). One participant was excluded from the analysis due to incorrect dosing of study medication.||Log10 IU/mL HCV RNA||Standard Deviation|Mean
134727|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 18, Month 24 (treatment period 2)|"Participants in the PRO analysis set with at least one post-baseline assessment in both periods and with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
134728|NCT00518531|Secondary|Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period|The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.|Month 6, Month 12 (treatment period 1)|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
134729|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Preference Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. The BMQ preference score, which measures a participant's overall evaluation of a medication, is based on the average of 7 items in the BMQ. The preference score ranges from 1 to 5, with higher scores indicating stronger preference for one medication over the other.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
134730|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ) Concern Score|The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. Participants' concern about the adverse consequences of taking the medication for controlling osteoporosis was based on the average of 10 items from the BMQ that form the concern score. The concern score ranges from 1 to 5, with higher scores indicating stronger concerns about the adverse consequences of taking the prescribed medication for controlling osteoporosis.|Baseline and Month 6, Month 12, Month 18, and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
134731|NCT00518531|Secondary|Beliefs About Medicines Questionnaire (BMQ): Necessity Score|"The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other.~Participants' beliefs about the necessity of the prescribed medication to treat osteoporosis were based on the average of 5 items from the BMQ that form the necessity score. The necessity score ranges from 1 to 5, with higher scores indicating stronger beliefs about the necessity of the prescribed medication for controlling osteoporosis."|Baseline, Month 6, Month 12, Month 18 and Month 24|"Participants in the PRO analysis set with observed data; n indicates the number of patients with available data at each time point."||scores on a scale||Standard Deviation|Mean
134732|NCT00518531|Secondary|Overall Satisfaction to Study Treatment|"Participant satisfaction with their treatment was assessed using question 7 (ie, “Please rate your satisfaction with the weekly pill on the following: frequency of administration; mode of administration [taking a pill]; convenience; overall satisfaction”) and question 8 (ie, “Please rate your satisfaction with the six month injection on the following: frequency of administration; mode of administration [receiving an injection]; convenience; overall satisfaction”) from the Preference Satisfaction Questionnaire (PSQ) at the end of each treatment period. The PSQ is a 34 item, self-report questionnaire of participants’ preference and satisfaction for each of the two study treatments. Possible answers include: Not at all Satisfied, A Little Satisfied, Moderately Satisfied, Quite Satisfied, and Very Satisfied."|End of treatment period 1 (Month 12)|The Patient Reported Outcomes (PRO) analysis set for each independent treatment period included patients in the FAS who received at least one dose of study drug and had at least one post-baseline assessment in the relevant treatment period. Analysis population includes patients with observed data for ≥1 question in the questionnaire.||Participants|||Number
134733|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the Second Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 2 (Month 13 to Month 24)|Crossover set||weeks||Standard Error|Mean
134734|NCT00518531|Secondary|Time to Non-persistence to Alendronate Treatment in the First Treatment Period|Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.|Treatment period 1 (Month 1 to Month 12)|Full analysis set||weeks||Standard Error|Mean
135031|NCT00516906|Secondary|Rating of Skin Condition|Ratings of skin condition for erythema on a 0 to 3 scale (0 = None, 1=Mild, 2=Moderate, 3=Severe)|Daily up to 7 Days (average 3-7 days of wear)|||Units on a scale||Standard Deviation|Mean
134735|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the Second Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 2 (Month 13 to Month 24)|crossover set||weeks||Standard Error|Mean
134736|NCT00518531|Secondary|Time to Non-compliance to Alendronate Treatment in the First Treatment Period|Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set||weeks||Standard Error|Mean
134737|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the Second Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 2 (Month 13 to Month 24)|Crossover set||weeks||Standard Error|Mean
134738|NCT00518531|Secondary|Time to Non-adherence to Alendronate Treatment in the First Treatment Period|Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.|Treatment Period 1 (Month 1 to Month 12)|Full analysis set||weeks||Standard Error|Mean
134739|NCT00518531|Secondary|Persistence With Treatment in the Second Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 2 (Month 13 to Month 24)|Crossover set||Participants|||Number
134740|NCT00518531|Secondary|Persistence With Treatment in the First Treatment Period|Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.|Treatment period 1 (Month 1 to Month 12)|Full analysis set||Participants|||Number
134741|NCT00518531|Secondary|Compliance With Treatment in the Second Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 2 (Month 13 to Month 24)|Crossover set||Participants|||Number
134742|NCT00518531|Secondary|Compliance With Treatment in the First Treatment Period|Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).|Treatment period 1 (Month 1 to Month 12)|Full analysis set||Participants|||Number
134743|NCT00518531|Secondary|Adherence With Treatment in the Second Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed nonadherent to treatment.|Treatment period 2 (Months 13 to 24)|The cross-over analysis set includes all participants who crossed over to their treatment period 2 treatment.||Participants|||Number
134744|NCT00518531|Primary|Adherence With Treatment in the First Treatment Period|A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.|Treatment period 1 (Month 1 to Month 12)|The full analysis set (FAS) includes all participants who were randomized.||Participants|||Number
134745|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134746|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134747|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134748|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134749|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134750|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134751|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134752|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134753|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134754|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134755|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
146793|NCT00413400|Primary|C-reactive Protein (CRP)|As a measure of C-reactive protein (CRP), which is an inflammatory marker, Log10 of the CRP at 6 months is reported|6 months|||Log10 mg/L||Standard Error|Mean
134756|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134757|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134758|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134759|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134760|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134761|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134762|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134763|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
146794|NCT00413374|Primary|Death||30 Days||||||
134764|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134765|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 7|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134766|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134767|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134768|NCT00518336|Secondary|Number of Subjects With Medically Signifant Conditions up to Year 9|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134769|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.||Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134770|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo).||Subjects|||Number
134771|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||Titer||95% Confidence Interval|Geometric Mean
134772|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked immunosorbent assay (ELISA) Units per milliliter (EL.U/mL).~The cut-off-vales assessed were >= 8 or 7 EL. U/mL for anti-HPV-16 and 18, respectively."|At Month 77 until year 9 (Month 113)|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||EL. U/mL||95% Confidence Interval|Geometric Mean
134773|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134774|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134775|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134776|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134777|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134778|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study"|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134779|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134780|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134781|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134782|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134783|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134784|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)||Subjects|||Number
134785|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134786|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134787|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134788|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134789|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134790|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study"|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study, who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134791|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134792|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 9|The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134793|NCT00518336|Secondary|Number of Subjects With SAEs up to Year 8|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134794|NCT00518336|Secondary|Number of Subjects With Serious Adverse Events (SAEs) up to Year 7|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134795|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 8|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134796|NCT00518336|Secondary|Number of Subjects With Medically Significant Conditions up to Year 7|"Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Medically significant conditions which were not unblinded at the time of the analysis are not presented yet."|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134797|NCT00518336|Secondary|Number of Subjects With NOAD up to Year 8|The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available.|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134798|NCT00518336|Secondary|Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7||Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134799|NCT00518336|Secondary|Number of Subjects With NOCD up to Year 8|"NOCDs included for example asthma, type I diabetes, allergies, ...~NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134800|NCT00518336|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7|NOCDs include for example asthma, type I diabetes, allergies, ...|Up to year 7|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134801|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset|Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Months 77-101|The analyses were performed on a subset of the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
134802|NCT00518336|Secondary|Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort|Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).|At Months 77-101|The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
134803|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134804|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134836|NCT00518284|Secondary|Target Lesion Revascularization (TLR) at 9 Months|Target lesion revascularization (TLR) was defined as repeat percutaneous intervention or bypass surgery of the previously treated target lesion (or blockage). The percentage of participants requiring revascularization of the target lesion was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
134805|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134806|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134807|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection|"Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134808|NCT00518336|Secondary|Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection|"Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H).~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134809|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134810|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134811|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134812|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134813|NCT00518336|Secondary|Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
147684|NCT00407537|Secondary|Change From Baseline in DBP at Month 12||Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHg||95% Confidence Interval|Least Squares Mean
134814|NCT00518336|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)||subjects|||Number
134815|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
134816|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
134817|NCT00518336|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
134818|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types|"Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||Subjects|||Number
134819|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
134820|NCT00518336|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
134821|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type|"Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
135032|NCT00516906|Secondary|Clinician Overall Satisfaction With Dressing|Clinician Overall Satisfaction with Dressing Five point scale: 1= Very Good, 5= Very poor|Daily up to 7 Days (average 3-7 days of wear)|||Units on a scale||Standard Deviation|Mean
134822|NCT00518336|Secondary|Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study."|Up to year 8|The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
134823|NCT00518336|Primary|Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18|Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.|Up to year 8|According-To-Protocol (ATP) cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.||subjects|||Number
134824|NCT00518323|Secondary|Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness|The sleep VAS for daytime drowsiness is a scale for measuring the drowsiness experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
134825|NCT00518323|Secondary|Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.|The sleep VAS for sleep quality is a scale for measuring the quality of sleep experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
134826|NCT00518323|Secondary|Change From Baseline to End Point in Children's Global Assessment (CGAS) Score|The CGAS score assesses psychological, social, and school functioning for children 6 to 17 years of age. Scores range from 1 to 100, where 100=best and 1=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
134827|NCT00518323|Secondary|Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S rating scale was used to assess the severity of a subject’s overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Full Range|Median
134828|NCT00518323|Primary|Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.|The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.|6 weeks|The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.||units on a scale||Standard Deviation|Mean
134829|NCT00518284|Secondary|Diameter Stenosis|Diameter stenosis is calculated as [1 - (minimum lumen diameter (MLD) / reference vessel diameter)] * 100, where the reference vessel diameter is the vessel diameter measured in a healthy segment of the target vessel proximal as close as possible to the lesion.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percent diameter stenosis||Standard Deviation|Mean
134830|NCT00518284|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
134831|NCT00518284|Secondary|Late Loss|Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.|Day 1 (following revascularization) and 9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||mm||Standard Deviation|Mean
134832|NCT00518284|Secondary|Minimum Lumen Diameter|Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||mm||Standard Deviation|Mean
134833|NCT00518284|Secondary|Number of Participants With a Stroke|The number of patients experiencing a stroke during the study. Stroke was defined as any sudden development of neurological deficits lasting more than 24 hours, and if a brain imaging study is performed it shows an infarction or hemorrhage. A transient ischemic attack is a neurological deficit lasting less than 24 hours and, if an imaging study is performed, shows no evidence of infarction or hemorrhage.|Up to 11 months|Treated population.||participants|||Number
134834|NCT00518284|Secondary|Number of Participants With Myocardial Infarction (MI)|The number of patients experiencing Myocardial Infarction (MI) during the study. Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.|Up to 11 months|Treated population.||participants|||Number
134835|NCT00518284|Secondary|Number of Deaths|Number of patients who died due to any cause.|Up to 11 months|Treated population.||participants|||Number
134838|NCT00518284|Secondary|Change From Baseline in Walking Impairment Questionnaire (WIQ) Score|The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient’s walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).|Baseline and Month 9|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||scores on a scale||Standard Deviation|Mean
134839|NCT00518284|Secondary|Systolic Velocity Ratio (SVR) > 2.0|The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
134840|NCT00518284|Primary|Target Vessel Revascularization at 9 Months|Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of > 50% confirmed by angiography.|9 months|Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.||percentage of participants|||Number
134841|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination|Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.|Days 1 to 7|The analysis was performed on the safety population.||Subjects|||Number
134842|NCT00518180|Secondary|Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.|Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.|Days 1 to 7|The analysis was performed on the safety set.||Subjects|||Number
134843|NCT00518180|Primary|Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)|To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||IU/mL||95% Confidence Interval|Geometric Mean
134844|NCT00518180|Secondary|Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN|To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
134845|NCT00518180|Secondary|Geometric Mean Titers (GMT) of Pertussis Antigens|To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
134846|NCT00518180|Secondary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus|To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||IU/mL||95% Confidence Interval|Geometric Mean
134847|NCT00518180|Secondary|The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus|The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of subjects||95% Confidence Interval|Number
134848|NCT00518180|Secondary|Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups|The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
134849|NCT00518180|Secondary|Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
134850|NCT00518180|Secondary|Percentage of Subjects With Anti-HPV Seroconversion|To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.|1 month post third HPV vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
134851|NCT00518180|Secondary|Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups|The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
134852|NCT00518180|Primary|Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL|To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone|1 month post Tdap vaccination|The analysis was performed on the per-protocol (PP) population. A total of 183 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.||Percentage of subjects||95% Confidence Interval|Number
134884|NCT00518011|Primary|Progression Free Survival|Progression free survival was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|Up to 2 years|Per protocol (PP) population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.||Week||95% Confidence Interval|Median
134853|NCT00518180|Primary|Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse|"Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.~Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post MenACWY vaccination|The analysis was performed on the per-protocol (PP) population. A total of 182 subjects were excluded from the PP population due to protocol deviations. The most common protocol deviations were blood draw performed outside the protocol-specified window.||Percentage of participants||95% Confidence Interval|Number
134854|NCT00518115|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK/PD Analysis Population: all participants in the PK Analysis Population with sufficient dosing history for inclusion in the PK/PD analysis||nanograms per milliliter||95% Confidence Interval|Mean
134855|NCT00518115|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population||hour^-1||95% Confidence Interval|Mean
134856|NCT00518115|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population||Liters||95% Confidence Interval|Mean
134857|NCT00518115|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.|Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed||milliliters per hour||95% Confidence Interval|Mean
134858|NCT00518115|Secondary|Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16|"The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, In the past week I was hungry; Q2, In the past week I thought about food; Q3, In the past week I wanted to eat; Q4, In the past week I ate more than I should have; Q5, In the past week, I craved specific food; Q6, In the past week when finished meals I felt full; Q7, In the past week when finished meals I felt satisfied."|Week 16|Safety Population. Only those participants available at the specified time point were analyzed.||Participants|||Number
134859|NCT00518115|Secondary|Change From Baseline in Functional Living Index – Emesis (FLIE) Scores at Week 16|The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.|Baseline and Week 16|Safety Population: all randomly assigned participants who received at least one dose of study drug. Only those participants available at the specified time point were analyzed. Change from Baseline was calculated as the score at Week 16 minus the score at Baseline.||Score on a scale||Standard Deviation|Mean
134860|NCT00518115|Secondary|Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16|Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||mmol/L||Standard Deviation|Mean
134861|NCT00518115|Secondary|Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16|Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Picomoles per liter (pmol/L)||Standard Deviation|Mean
134862|NCT00518115|Secondary|Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16|Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Nanograms per liter (ng/L)||Standard Deviation|Mean
134863|NCT00518115|Secondary|Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16|Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Nanomoles per liter (nmol/L)||Standard Deviation|Mean
134864|NCT00518115|Secondary|Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16|Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 5, 8, 12, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Micromoles per liter (µmol/L)||Standard Deviation|Mean
134865|NCT00518115|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
134866|NCT00518115|Secondary|Percent Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the ([value at Week 16 minus the Baseline value] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.||Percent change||Standard Deviation|Mean
134867|NCT00518115|Secondary|Change From Baseline in Body Weight at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.||Kilograms (Kg)||Standard Deviation|Mean
134868|NCT00518115|Secondary|Change From Baseline in Waist Circumference at Week 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.||Centimeters||Standard Deviation|Mean
134869|NCT00518115|Secondary|Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|The number of participants who achieved target values for HbA1c (i.e., HbA1c <6.5% and >=6.5% to <7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Participants|||Number
134870|NCT00518115|Secondary|Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Percentage of HbA1c in the blood||Standard Deviation|Mean
134871|NCT00518115|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomly assigned participants with at least one post-Baseline assessment of the primary endpoint. Participants from the exenatide arm were not included in the analysis. Only those participants with a value at Baseline and at the specified visit were analyzed.||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
134872|NCT00518089|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
134873|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6|Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
147685|NCT00407537|Secondary|Change From Baseline in SBP at Month 12||Baseline, Month 12|FAS, number of participants analyzed refers to number of participants contributing to data.||mmHg||95% Confidence Interval|Least Squares Mean
134874|NCT00518089|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6|Percentage of patients with clinical improvement of ocular signs up to Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus), with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
134875|NCT00518089|Secondary|Percentage of Patients With Microbiological Cure Up to Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated up to Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
134876|NCT00518089|Secondary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
134877|NCT00518011|Secondary|Mean Change in Body Temperature From Baseline|Mean change in body temperature from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose/infusion and had at least one safety assessment performed at baseline.||Fahrenheit||Standard Deviation|Mean
134878|NCT00518011|Secondary|Mean Change in Blood Pressure From Baseline|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded as vital parameters in this study. Mean change in SBP and DBP from Baseline for each cycle calculated as Day 1 of each cycle value minus baseline value.|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at Baseline.||mm Hg||Standard Deviation|Mean
134879|NCT00518011|Secondary|Mean Change in Pulse Rate From Baseline|Mean change in pulse rate from Baseline for each cycle calculated as Day 1 of each cycle value minus Baseline value|Baseline (Day -14 to Day 0), Cycle 1 (Days 1, 8, 15 and 22), Cycle 2 (Days 1, 8, 15 and 22), Cycle 3 (Days 1, 8, and 15), Cycle 4 (Days 1, 8, and 15), Cycle 5 (Days 1, 8, and 15), Cycle 6 (Days 1, 8, and 15)|Safety population included all participants who received at least one dose or infusion of study treatment and had a safety assessment performed at baseline.||beats per minute||Standard Deviation|Mean
134880|NCT00518011|Secondary|Overall Survival|Overall survival was defined as the interval between the date of randomization to the date of death from any cause.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death||Week||95% Confidence Interval|Median
134881|NCT00518011|Secondary|Duration of Response|Duration of response was defined as the interval between the date of CR or PR was first recorded to the date on which progressive disease was first noted or date of death.|Up to 2 years|PP population included all randomized participants received at least one dose of study medication and had at least one post baseline tumor assessment or record of death. Participants available at the time of evaluation of duration of response were included in the analysis.||Week||Standard Deviation|Mean
134882|NCT00518011|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of participants who have any evidence of confirmed objective CR or PR or Stable disease (SD) (where SD was maintained for 8 weeks), as assessed by the RECIST version 1.0 criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of the LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of the LD since the treatment started. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.||Percentage of participants|||Number
134883|NCT00518011|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of participants who have any evidence of confirmed objective of complete response (CR) + partial response (PR), as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. As per the RECIST Version 1.0 CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.|Up to 2 years|PP population included all randomized participants who received at least one dose of study medication and had at least one post baseline tumor assessment or record of death.||Percentage of participants|||Number
134885|NCT00517933|Secondary|Short Form Health Survey (SF36) Aggregate Physical|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 Aggregate Physical."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134886|NCT00517933|Secondary|Change in SF36 Aggregate Physical (Adjusted Value)|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134887|NCT00517933|Secondary|Short Form Health Survey (SF36) General Health|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Mean raw scores of SF36 General Health"|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134888|NCT00517933|Secondary|Change in Short Form Health Survey (SF36) General Health - Adjusted Value|"The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores.~Each score ranges from 0 to 100, with a higher score indicating better function.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134889|NCT00517933|Secondary|EuroQOL (EQ-5D) Utility|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Mean raw scores of EuroQOL Utility."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134890|NCT00517933|Secondary|Change in EuroQOL (EQ-5D) Utility - Adjusted Value|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134891|NCT00517933|Secondary|EuroQOL Thermometer|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Mean raw scores of EuroQOL Thermometer."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134892|NCT00517933|Secondary|Change in EuroQOL Thermometer (Adjusted Value)|"The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state.~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134893|NCT00517933|Secondary|ICECAP-O|The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134894|NCT00517933|Secondary|Change in ICECAP-O Adjusted Value|"The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best).~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134895|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Impacts Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134896|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Impacts Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134897|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Activity Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134898|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Activity Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134899|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Symptoms Score)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George’s Respiratory Questionnaire.|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
135006|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8||up to week 8||||||
134900|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Symptoms Score) Adjusted Value|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 weeks|||units on a scale||95% Confidence Interval|Mean
134901|NCT00517933|Secondary|St. George’s Respiratory Questionnaire (Total Score)|Mean raw scores of the St. George’s Respiratory Questionnaire. The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134902|NCT00517933|Secondary|Change in St. George’s Respiratory Questionnaire (Total Score) (Adjusted Values)|The St. George’s Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 week|||units on a scale||95% Confidence Interval|Mean
134903|NCT00517933|Secondary|Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.|Baseline, 6 week, 12 week|||units on a scale||Standard Deviation|Mean
134904|NCT00517933|Secondary|Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, 12 week|||units on a scale||95% Confidence Interval|Mean
134905|NCT00517933|Secondary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT||percentage of predicted (DLCO)||Standard Deviation|Mean
134906|NCT00517933|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values|Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, Week 12|ITT||percentage of predicted (DLCO)||95% Confidence Interval|Least Squares Mean
134907|NCT00517933|Secondary|Forced Vital Capacity (FVC)|Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups|Baseline, Week 6, Week 12|ITT||liters||Standard Deviation|Mean
134908|NCT00517933|Secondary|Change in Forced Vital Capacity (FVC) Adjusted Values|Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, Week 12|ITT||liters||95% Confidence Interval|Least Squares Mean
134909|NCT00517933|Secondary|University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores)~Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo."|Baseline, 6 weeks, 12 weeks|||units on a scale||Standard Deviation|Mean
134910|NCT00517933|Secondary|Change in Dyspnea|"The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = not at all to 5 = maximal or unable to do because of breathlessness) to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better."|Measured from enrollment to 12 weeks (phase I)|||units on a scale||95% Confidence Interval|Mean
134911|NCT00517933|Secondary|Desaturation During 6-minute Walk Test (6MWT)|The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.|Week 12|ITT population||percentage of participants||95% Confidence Interval|Number
134912|NCT00517933|Secondary|Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Baseline, week 12|||meters||95% Confidence Interval|Mean
134913|NCT00517933|Secondary|6-minute Walk Distance (6MWT)|The 6MWT measures the distance that a participant can walk in a period of 6 minutes.|Baseline, 6 week, 12 week|||meters||Standard Deviation|Mean
134914|NCT00517933|Primary|Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)|This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil – placebo.|Measured at Week 12|||participants|||Number
134915|NCT00517881|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Week 0 up to Week 24|Safety population||participants|||Number
134916|NCT00517881|Secondary|Percentage of Participants With Red Blood Cell Transfusion During the Study|Percentage of participant who required red blood cell transfusion during the study was reported.|Week 0 up to Week 24|ITT Population||percentage of participants|||Number
134917|NCT00517881|Secondary|Percentage of Participants Requiring Any Dose Adjustment|Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.|Week 1 up to Week 16 and Week 17 up to Week 24|ITT Population. Here, 'n' signifies the number of participants evaluable for specified category.||percentage of participants|||Number
134918|NCT00517881|Secondary|Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP|Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population||days||Standard Deviation|Mean
134919|NCT00517881|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP|Percentage of participants maintaining hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.|Week 17 up to Week 24|ITT Population; data missing at the end of the EEP was handled using the last value carried forward method.||percentage of participants||95% Confidence Interval|Number
134920|NCT00517881|Secondary|Change in Hemoglobin Concentration Between Reference (SVP) and EEP|The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.|Week 17 up to Week 24|ITT population; data missing at the end of the EEP was handled using the last value carried forward method.||g/dL||Standard Deviation|Mean
134921|NCT00517881|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range|Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.|Week 17 up to Week 24|The Intention-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (week 0) and for whom data for at least 1 follow-up variable was available. Data missing at the end of the EEP (that is, the last measured hemoglobin value before Week 24) was handled using the last value carried forward method.||percentage of participants||95% Confidence Interval|Number
134922|NCT00517829|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR).||months||95% Confidence Interval|Median
134923|NCT00517829|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|Treatment will continue until disease progression or intolerable toxicity|Patients who achieve a major objective response (CR or PR)||months||95% Confidence Interval|Median
134924|NCT00517829|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Treatment will continue until disease progression or intolerable toxicity.|Evaluable Population||percentage of participants||95% Confidence Interval|Number
134925|NCT00517829|Secondary|Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|Treatment will continue until disease progression or intolerable toxicity|ITT population||months||95% Confidence Interval|Median
134926|NCT00517829|Primary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Treatment will continue until disease progression or intolerable toxicity, up to 2 years|ITT population||months||95% Confidence Interval|Median
134927|NCT00517751|Other Pre-specified|Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery||Overall study period|||percentage of participants|||Number
134928|NCT00517751|Other Pre-specified|Percent of Subjects Who Reported Implant-Related Adverse Events||Overall study period|||percentage of participants|||Number
134929|NCT00517751|Secondary|Right Leg Pain in Numerical Rating Scales (NRS)|"Right leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134930|NCT00517751|Secondary|Left Leg Pain in Numerical Rating Scales (NRS)|"Left leg pain was measured using NRS. Patients rated their leg pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134931|NCT00517751|Secondary|Back Pain in Numerical Rating Scales (NRS)|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134932|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
134933|NCT00517751|Secondary|General Health Status -- SF-36 MCS|MCS score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134934|NCT00517751|Secondary|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134935|NCT00517751|Secondary|Oswestry Disability Index (ODI) Score|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134936|NCT00517751|Secondary|Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment|Success rate in PS domain of ZCQ at post treatment is reported as the percentage of participants who had success in PS domain of ZCQ. The PS success was defined as PS score less than 2.5.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months|||percentage of participants|||Number
134937|NCT00517751|Secondary|Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134938|NCT00517751|Secondary|Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in PF domain of ZCQ is reported as percentage of participants who had success in PF domain of ZCQ. The PF success was defined as clinically significant improvement by at least 0.5 points in PF score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months|||percentage of participants|||Number
134939|NCT00517751|Secondary|Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. If more than one item were missing, the PF score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134940|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months|The percent of subjects with Pfirrmann grades increased from baseline at adjacent levels at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
134941|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 60 months is reported.|60 months|At 60 months, 16 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
134942|NCT00517751|Other Pre-specified|Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months|The Pfirrmann Grading System is descriptive and grades the status on an intervertebral disc as visualized with MRI using a 5-point system (grade I, II, III, IV or V). Grade I: disc is homogeneous with bright hyper-intense white signal intensity and normal disc height. Grade V: disc is inhomogeneous with hypo-intense black signal intensity and there is no more distinction between the nucleus and annulus, the disc space is collapsed. The percent of subjects with Pfirrmann grades increased from baseline at 24 months is reported.|24 months|At 24 months, 53 subjects were evaluable for Pfirrmann Grade assessment.||percentage of participants|||Number
134943|NCT00517751|Secondary|Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)|Success rate in SS domain of ZCQ is reported as percentage of participants who had success in SS domain of the ZCQ. The SS success was defined as clinically significant improvement by at least 0.5 point in SS score compared to preoperative baseline.|6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months|||percentage of participants|||Number
134944|NCT00517751|Secondary|Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. If more than two items were missing, the SS score was considered as missing.|Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months|||units on a scale||Standard Deviation|Mean
134945|NCT00517751|Secondary|Treatment Success Rate at 60 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:~Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the ZCQ compared to preoperative baseline~Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline~Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5~No additional surgery for lumbar stenosis performed~Maintenance of distraction~No dislodgement of the implant~No device-related complications"|60 months|At 60 months, 62 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.||percentage of participants|||Number
135007|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat||up to 48 weeks||||||
135008|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF||up to 48 weeks||||||
135009|NCT00517192|Secondary|Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored||up to 48 weeks||||||
135010|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat||up to 48 weeks||||||
134946|NCT00517751|Primary|Treatment Success Rate at 24 Months|"Treatment success rate is reported as the percentage of participants who met all of the following criteria:~Clinically significant improvement (by at least 0.5 points) in the Symptom Severity (SS) domain of the Zurich Claudication Questionnaire (ZCQ) compared to preoperative baseline~Clinically significant improvement (by at least 0.5 points) in the Physical Function (PF) domain of the ZCQ compared to pre-operative baseline~Patient satisfaction with treatment defined as a Patient Satisfaction (PS) score < 2.5~No additional surgery for lumbar stenosis performed~Maintenance of distraction~No dislodgement of the implant~No device-related complications"|24 months|At 24 months, 94 subjects were evaluable for overall treatment success. Once subjects failed on additional surgery for lumbar stenosis or dislodgement of the implant or device-related complications, they failed at later visits no matter whether they had data or not.||percentage of participants|||Number
134947|NCT00517699|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time interval between the entry into trial and occurrence of one of the following events: progression of disease (PD) or death as a result of primary central nervous system lymphoma (PCNSL). Participants who were withdrawn from the study without documented progression and for whom there existed case report form (CRF) evidence that evaluations had been made, were censored at the date of last tumor assessment when participant was known to be progression free. Participants without postbaseline tumor assessments but known to be alive were censored at the time of randomization. PD required a ≥25% increase in the contrast-enhanced lesion seen on MRI as compared with baseline or best response (comparison should be made to the smallest of multiple lesions); progression of ocular disease as indicated by an increase in vitreous cell count or progressive retinal or optic nerve infiltration, appearance of any new lesion or site of disease during or at the end of therapy.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
134948|NCT00517699|Secondary|Overall Survival|Time from entry into trial until death of any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the baseline date.|Time of last follow-up assessment between Day 1 and 3 years|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
134949|NCT00517699|Secondary|Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse||Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
134950|NCT00517699|Primary|Percentage of Participants With a CR, CRu or Partial Response (PR)|PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
134951|NCT00517699|Primary|Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)|CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.|Week 24|Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.|||||
134952|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 14|Amount of serum IL-5 measured from blood draws|0-6 hours post allergen challenge, 1 hour after dosing, Day 14||||||
134953|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Serum IL-5 Post-Allergen Challenge on Day 35|Amount of serum interleukin (IL)-5 measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35||||||
134954|NCT00517634|Secondary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 14|Number of peripheral blood eosinophils measured from blood draws|0-6 hours, post allergen challenge, 1 hour post treatment, Day 14|ITT Population||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
134955|NCT00517634|Primary|Weighted Mean Change From Baseline Over 0-6 Hours in Blood Eosinophils Post-Allergen Challenge on Day 35|Number of peripheral blood eosinophils measured from blood draws|0-6 hours post allergen challenge, 10-11 hours post treatment, Day 35|Intent-to-Treat (ITT) Population: All participants receiving at least one dose of study medication who had at least one post-randomization efficacy assessment||Giga Units per Liter (GI/L)||95% Confidence Interval|Mean
134956|NCT00516386|Secondary|Change in Levels of N-terminal Propeptide of Type 1 Procollagen (P1NP) Following rhIGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days|||ng/ml||Standard Error|Mean
134957|NCT00516386|Primary|Change in Levels of Insulin Like Growth Factor-1 (IGF-I) Following Recombinant Human (rh) IGF-1 Administration in Girls With Anorexia Nervosa||Baseline and 7-10 days|16 subjects were screened for the study, and 10 completed the study. 10 were analyzed.||ng/ml||Standard Error|Mean
135011|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF||up to 48 weeks||||||
135012|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored||up to 48 weeks||||||
135013|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat||up to 48 weeks||||||
135014|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF||up to 48 weeks||||||
135015|NCT00517192|Secondary|Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored||up to 48 weeks||||||
134958|NCT00517595|Other Pre-specified|Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.||Months||95% Confidence Interval|Median
134959|NCT00517595|Other Pre-specified|Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. The median progression free survival is the parameter used to describe PFS. ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment).|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.|Note that N=18 patients for the Baseline ECOG performance status 0 group, and N=30 patients for the Baseline ECOG performance status 1 group.||Months||95% Confidence Interval|Median
134960|NCT00517595|Secondary|Overall Response|Response was evaluated via changes from baseline in radiological tumor measurements performed after every 4th treatment cycle and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks.|||Participants|||Number
134961|NCT00517595|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|OS was measured from day 1 of treatment until time of death, assessed up to 20 months.|||Months||95% Confidence Interval|Median
134962|NCT00517595|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from treatment start until objective tumor progression. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median time to progression is the parameter used to describe TTP.|TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months.|||Months||95% Confidence Interval|Median
134963|NCT00517595|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months.|||Months||95% Confidence Interval|Median
134964|NCT00517530|Other Pre-specified|Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients||at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)|||micrograms/mL||Geometric Coefficient of Variation|Geometric Mean
134965|NCT00517530|Secondary|Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study|Blood samples were taken on Day 1 (pre-infusion, end of infusion, 3-6 hours post-infusion) of Cycle 1. Nonlinear mixed-effects modeling (with NONMEM software) was used to analyze the pooled samples for dose-concentration-time data of obinutuzumab.|Day 1 of Cycle 1|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
134966|NCT00517530|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants|Obinutuzumab serum pharmacokinetic (PK) parameters in NHL participants following ascending doses.|at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days)|Pharmacokinetics (PK)- evaluable population at the given dose (e.g., 3 or more participants at any of the given time points). Other doses did not have a PK-evaluable population, so were not included in the table of results. Due to the limited sampling schedule derived PK parameters could not be accurately obtained during Cycle 1 and Cycle 8.||µm/ml*day||Geometric Coefficient of Variation|Geometric Mean
134967|NCT00517530|Secondary|Percentage of Retreated Participants With Response|Patients who might benefit from retreatment were allowed to be treated again at the request of the investigator.|by Cutoff Date: 25 November 2013 (within 4 years, 2 months)|Retreated participants||percentage of participants|||Number
134968|NCT00517530|Secondary|Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study|B-cell depletion was defined in two ways: definition 1 – decrease below 5% baseline level and definition 2 – decrease below 0.04 x 109/L. B-cell recovery was defined in two ways: definition 1 – return to at least 50% of baseline level and definition 2 – return to at least 0.08 x 109/L.|by the end of Phase II (within 3 years, 4 months)|Participants analyzed include those with B-cell depletion at the end of treatment (N), with assessments (n) at each time point.||participants|||Number
134969|NCT00517530|Secondary|Participants With Event-Free Survival (EFS) in Phase II of the Study|EFS is defined as the time from start of treatment to disease progression/relapse, death or, in case of early withdrawal from the treatment period, the (end) date of last dose, whatever comes first.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|||participants|||Number
135016|NCT00517192|Secondary|Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.||48 weeks of treatment||||||
134970|NCT00517530|Secondary|Duration of Response by Disease Type in Phase II of the Study|Duration of complete response was defined as the time from the first complete or partial response until disease progression (PD) or death, whichever occurred first. For non-Hodgkin’s lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is PET-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab. Data reported for each disease cohort.||days||Full Range|Median
134971|NCT00517530|Secondary|Progression-free Survival (PFS) in Phase II of the Study|PFS was defined as the time from start of treatment to disease progression (PD) or death due to any cause, whichever occurred first. For non-Hodgkin’s lymphoma participants, PD was defined as >= 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for participants with a partial response or non-responders or the appearance of any new lesion during or at the end of therapy. For chronic lymphocytic leukemia participants, PD was defined as: (1) A >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules); a lymph node with a short axis of < 1.0 cm must increase by >= 50% and to a size of 1.5×1.5 cm or > 1.5 cm in the longest axis. (2) Appearance of any new lesion > 1 cm in the short axis. (4) A new site that is positron emission tomography (PET)-positive with histological confirmation.|by the end of the follow-up period in Phase II of the study (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.||days||95% Confidence Interval|Median
134972|NCT00517530|Secondary|Percentage of Participants With Partial Response (PR) in Phase II of the Study|A PR was defined as a >=50% decrease in SPD of the 6 largest nodes or nodal masses; no increase in size of other nodes, liver, or spleen; regression of splenic and hepatic nodules by >=50% in their SPD or, for single nodules, in the long axis (CLL only); and no new disease sites.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|||percentage of participants|||Number
134973|NCT00517530|Secondary|Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study|A complete response was defined as the disappearance of all evidence of disease (NHL) and symptoms; normalization of biochemical abnormalities (NHL); regression of lymph nodes and nodal masses to normal size; decrease of nodes in the sum of the products of the greatest diameters (SPD); regression in size of the spleen and/or liver, should not be palpable, and disappearance of nodules related to lymphoma (CLL). Complete/unconfirmed (CRu) response includes NHL patients with one or more of the following: 1) a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the SPD; 2) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). Complete Response with Incomplete Bone Marrow Recovery (CRi) was measured only in patients with CLL.|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|||percentage of participants|||Number
134974|NCT00517530|Primary|Percentage of Participants With Best Overall Response in Phase II of the Study|Best overall response (BOR) was defined as the percentage of participants with a complete response (CR) or partial response (PR)|by Cutoff Date: 31 March 2012 (within 3 years, 4 months)|Safety population: All enrolled participants in Phase II, who had received at least 1 dose of obinutuzumab.||percentage of participants|||Number
134975|NCT00517530|Primary|Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study|Dose-limiting toxicities were defined as obinutuzumab-related adverse events occurring within the first 28 days of each administration of obinutuzumab, with the exception of B-cell depletion and lymphopenia which are expected outcomes of treatment with obinutuzumab.|Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months)|Safety population: All enrolled participants in Phase I, who had received at least 1 dose of obinutuzumab by 6 months.||percentage of participants|||Number
134976|NCT00517413|Secondary|Mean Ferritin Levels Over Time|Ferritin is a protein found inside cells that stores iron so that the body can use it later. A ferritin test indirectly measures the amount of iron in your blood. The Ferritin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for ferritin are as follows: Female: min-max for lower limit=6 - 50 mcg/L and min-max for upper limit=120 - 400 mcg/L; Male: min-max for lower limit=10 - 50 mcg/L and min-max for upper limit=200 - 400 mcg/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||mcg/L||Standard Deviation|Mean
134977|NCT00517413|Secondary|Mean C-Reactive Protein Levels Over Time|C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The CRP test is a general test to check for inflammation in the body.The CRP levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for CRP are as follows: Female/Male: min-max for lower limit=0 - 10 mg/L and min-max for upper limit=0.5 - 30 mg/L.|Baseline (Week 0), 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||mg/L||Standard Deviation|Mean
134978|NCT00517413|Secondary|Mean Albumin and Transferrin Levels Over Time|The albumin and transferrin levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for albumin are as follows: Female/Male: min-max for lower limit=30 - 35 g/L and min-max for upper limit=48 – 55 g/L. The standard reference ranges for transferrin are as follows: Female/Male: min-max for lower limit=1.5 - 2.3 g/L and min-max for upper limit=2.87 - 4.3 g/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study.||g/L||Standard Deviation|Mean
135017|NCT00517192|Secondary|Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.||48 weeks of treatment||||||
134979|NCT00517413|Secondary|Mean Transferrin Saturation Levels Over Time|Transferrin saturation (TSAT) is the ratio of serum iron and total iron-binding capacity. Transferrin is a blood protein that picks up iron absorbed by the intestines and transports it from one location to another. When iron absorption is abnormally high, transferrin proteins become more saturated with iron. An elevated TS value therefore reflects an increase in iron absorption. The TSAT levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. TSAT was calculated automatically in the electronic case report form (eCRF) according to the following formulae: TSAT= (Serum Iron*100)/(Transferrin*1.41) or TSAT=(Serum Iron*100)/TIBC. Calculated data was not provided by laboratory; therefore no reference range is available.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||Percentage of Transferrin Saturation||Standard Deviation|Mean
134980|NCT00517413|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The creatinine, iron, and total iron binding capacity (TIBC) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for creatinine are as follows: Female: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=79.56 - 123.76 mmol/L; Male: min-max for lower limit=0 - 70.72 mmol/L and min-max for upper limit=97.24 - 123.76 mmol/L. The standard reference ranges for iron are as follows: Female: min-max for lower limit=6.265 - 10.74 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L and Male: min-max for lower limit=6.265 - 11.635 mmol/L and min-max for upper limit=25.06 - 32.22 mmol/L. The standard reference ranges for TIBC are as follows: Female: min-max for lower limit=19.69 - 49.046 mmol/L and min-max for upper limit=62.65 - 88.963 mmol/L and Male: min-max for lower limit=19.69 - 52.089 mmol/L and min-max for upper limit=62.65 - 80.55 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||μmol/L||Standard Deviation|Mean
134981|NCT00517413|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for phosphate are as follows: Female/Male: min-max for lower limit= 0.48435 - 0.9687 mmol/L and min-max for upper limit=1.45305 - 2.2603 mmol/L. The standard reference ranges for potassium are as follows: Female/Male: min-max for lower limit=3.1 - 3.7 mmol/L and min-max for upper limit=5 - 5.5 mmol/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||mmol/L||Standard Deviation|Mean
134982|NCT00517413|Secondary|Mean White Blood Cells and Thrombocyte Levels Over Time|The white blood cells (WBC) and thrombocyte levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference ranges for WBC are as follows: Female/Male: min-max for lower limit= 3.5 - 5*10^9 cells/L and min-max of upper limit= 9 -13.5*10^9 cells/L. The standard reference ranges for thrombocyte are as follows: Female/Male: min-max for lower limit= 130 – 150*10^9 cells/L and min-max of upper limit= 300 - 450*10^9 cells/L.|Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||10^9 cells/L||Standard Deviation|Mean
134983|NCT00517413|Secondary|Mean Hematocrit Levels Over Time|The haematocrit (HCT) levels in fraction were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for hematocrit are as follows: Female: min-max for lower limit=0.12 - 0.38 and min-max of upper limit=0.43 - 0.537; Male: min-max for lower limit=0.35 - 0.45 and min-max of upper limit=0.45 - 0.54.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||Proportion of red blood cells in blood||Standard Deviation|Mean
134984|NCT00517413|Secondary|Mean Haemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The standard reference range for Hb are as follows: Female: min-max for lower limit=11 to 13 g/dL and min-max for upper limit=14 to 18.1 g/dL; Male: min-max for lower limit=12 to 14.2 g/dL and min-max for upper limit=16 to 18.1 g/dL.|Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|The safety population included all participants who entered into the study. n = the number of participants analyzed at a given time point.||g/dL||Standard Deviation|Mean
134985|NCT00517413|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|Adverse event (AE) and Serious adverse event (SAE) data was reported for the safety population which included all participants who entered into the study.|Up to Week 52|The safety population included all participants who entered into the study.||participants|||Number
134986|NCT00517413|Secondary|Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red blood cell (RBC) transfusions were permitted during the treatment period in case of medical need. The pre-transfusion Hb level was measured before any transfusion was administered.|Baseline (Week 0) to Week 44|The safety population included all participants who entered into the study.||participants|||Number
134987|NCT00517413|Secondary|Mean Monthly Dose of C.E.R.A During the DTP and EEP|The initial dose of C.E.R.A. was 120, 200, or 360 mcg IV or SC every 4 weeks for 48 weeks, which was based on the last dose of the previous ESA. Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP and the EEP. The reference Hb value was taken as the mean of all Hb assessments during the stability verification period. The mean monthly doses of C.E.R.A during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||mcg||Standard Deviation|Mean
135018|NCT00517192|Secondary|Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).||48 weeks of treatment||||||
135019|NCT00517192|Primary|Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.||48 weeks of treatment||||||
148568|NCT00399542|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
134988|NCT00517413|Secondary|Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP|Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant’s Hb within a range of +/-1.0 g/dL of the reference Hb concentration and between 10.5 and 12.5 g/dL throughout the DTP (Week 0 to Week 16) and the EEP (Weeks 16 to 24). The reference Hb value was taken as the mean of all Hb assessments during the stability verification period (Weeks -4, -3, -2, -1). The percentage of participants requiring C.E.R.A dose adjustments during the DTP and EEP are presented.|Baseline (Week 0) to Week 24|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||Percentage of participants|||Number
134989|NCT00517413|Secondary|Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean C.E.R.A dose required to maintain the Hb level within the range 10.5-12.5 g/dL throughout the EEP is presented.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||mcg||Standard Deviation|Mean
134990|NCT00517413|Secondary|Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean time (days) spent by the participants in the Hb target range 10.5 to 12.5 is reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||days||Standard Deviation|Mean
134991|NCT00517413|Secondary|Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The percentage of participants maintaining their mean Hb concentration within the target range 10.5 and 12.5 g/dL throughout the EEP are reported.|EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||Percentage of participants||95% Confidence Interval|Number
134992|NCT00517413|Secondary|Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP|The Hb levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The mean change in the Hb concentration between the Stability Verification Period (SVP) and the EEP is reported.|SVP (Week -4 to -1), EEP (Week 16 to 24)|The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.||g/dL||Standard Deviation|Mean
134993|NCT00517413|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter|The haemoglobin (Hb) levels were recorded for each participant at enrollment and at different time points during the study up to Week 48. The reference Hb value was defined on the basis of individual participant’s all assessments at Weeks -4, -3, -2, -1 and 0. The Hb value on the first day of first dose (Week 0) was included in the calculation, as this assessment was performed before the first dose was given. The percentage of participants maintaining their mean Hb concentration within +/-1.0 gram/deciliter (g/dL) of their reference Hb and between 10.5 and 12.5 g/dL are reported for efficacy evaluation period (EEP). Efficacy evaluation period was from Week 16 to Week 24 after completion of 16-week dose titration period (DTP).|EEP (Week 16 to 24)|The Per-Protocol Population (PP) included all participants in the safety population except those who had <3 recorded Hb values; withdrawn; inadequate iron defined as mean serum ferritin =<100 nanogram/milliliter (ng/mL) or mean TSAT=<20% or mean hypochromic RBCs>=10%; or had missing administration of C.E.R.A. all during EEP (Week 16-24).||Percentage of participants||95% Confidence Interval|Number
134994|NCT00517361|Secondary|Correlation of Response to BRCA1 Methylation Status|The methylation status of the tumor is defined using Methylation Specific polymerase chain reaction and/or pyrosequencing.|Up to 5 years|This study has been terminated due to poor accrual.|||||
134995|NCT00517361|Secondary|Duration of Response||Up to 5 years|This study has been terminated due to poor accrual.|||||
134996|NCT00517361|Secondary|Response Rate|Response is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]: Complete Response (CR), Disappearance of all target lesions or disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Up to 5 years|This study has been terminated due to poor accrual.|||||
134997|NCT00517361|Primary|Progression Free Survival|Progression is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 5 years|This study has been terminated due to poor accrual.|||||
134998|NCT00517192|Secondary|Occurrence of New AIDS Progression Events or Death||through 48 weeks of treatment||||||
134999|NCT00517192|Secondary|Change From Baseline in log10 Viral Load up to Week 48||up to week 48||||||
135000|NCT00517192|Secondary|Change From Baseline in CD4+ Cell Count up to Week 48||up to week 48||||||
135001|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 48||up to week 48||||||
135002|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 24||up to week 24||||||
135003|NCT00517192|Secondary|Daily Average in Viral Load Change From Baseline up to Week 8||up to week 8||||||
135004|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 48||up to week 48||||||
135005|NCT00517192|Secondary|Daily Average in CD4+ Cell Count Change From Baseline up to Week 24||up to week 24||||||
135034|NCT00516893|Secondary|Annualized Relapse Rate|Annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of years the participant was followed in the study. The annualized relapse rate was based only on those relapses that were determined to meet the definition of relapse per the investigator’s clinical judgment. New or recurrent symptoms that occurred less than 30 days following the onset of a protocol-defined relapse were considered part of the same relapse.|Through Week 36|Participants who received at least 1 dose of study drug.||relapses/participant-years|||Number
135035|NCT00516893|Secondary|Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Week 36|Participants with EDSS scores at Baseline and Week 36 (includes participants who withdrew from the study).||scores on a scale||Standard Deviation|Mean
135036|NCT00516893|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|AE: any sign, symptom, or diagnosis/disease that was unfavorable or unintended, new, or if pre-existing, worsened in a participant administered a study treatment and that did not necessarily have a causal relationship with this treatment. SAE: an event that resulted in death; an event that, in the view of the investigator, placed the participant at immediate risk of death (life-threatening event); an outcome that resulted in a congenital anomaly/birth defect diagnosed in a child of a participant in this study; an event that required or prolonged inpatient hospitalization; an event that resulted in persistent or significant disability/incapacity; any other medically important event that, in the opinion of the investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed above. Events were classified as ‘related’ or ‘not related’ to study drug, and categorized as ‘mild’ moderate’ or ‘severe’ per protocol.|AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.|Participants who received at least 1 dose of study drug.||participants|||Number
135037|NCT00516893|Primary|Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status|Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.|Assessed every 12 weeks from Week 0 (Baseline) to Week 36|Participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody assessment after the first dose.||participants|||Number
135038|NCT00516737|Secondary|Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose|"Level of functional disability was assessed on a paper diary by the participants.~Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose."|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
135039|NCT00516737|Secondary|Number of Participants With Absence of Nausea at 2 Hours Post-dose|Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
135040|NCT00516737|Secondary|Number of Participants With Absence of Phonophobia at 2 Hours Post-dose|Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
135041|NCT00516737|Secondary|Number of Participants With Absence of Photophobia at 2 Hours Post-dose|Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.|2 hours post-dose|The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
135042|NCT00516737|Secondary|Number of Participants With no Rescue Use up to 24 Hours Post-Dose|Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.|24 hours post-dose|The FAS population included all randomized and treated participants.||Participants|||Number
135043|NCT00516737|Secondary|Number of Participants With 24-Hour Sustained Pain Freedom|24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.|24 hours post-dose|The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.||Participants|||Number
135044|NCT00516737|Primary|Number of Participants Who Are Pain Free at 2 Hours Post-Dose|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.|2 hours post-dose|Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
135045|NCT00516321|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
135190|NCT00515463|Secondary|Eosinophils Change From Baseline at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
135046|NCT00516321|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Kilograms (kg)||Standard Deviation|Mean
135047|NCT00516321|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase|Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||beats per minute||Standard Deviation|Mean
135048|NCT00516321|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
135049|NCT00516321|Secondary|Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS."|End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
135050|NCT00516321|Secondary|Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase|"Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of abnormal alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment."|DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)|Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given).||participants|||Number
135051|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase|Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
135052|NCT00516321|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population||participants|||Number
135053|NCT00516321|Secondary|Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase|Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Safety DB Population: all randomized participants who had received study drug in the DB Phase||participants|||Number
135164|NCT00515502|Primary|Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Percentage||Standard Deviation|Mean
135054|NCT00516321|Secondary|Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase|There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study||participants|||Number
135055|NCT00516321|Secondary|Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase|The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
135056|NCT00516321|Secondary|Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase|The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. One participant could have had more than one dose reduction.||participants|||Number
135057|NCT00516321|Secondary|Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase|Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population. Only those participants with dose reductions were analyzed.||weeks||Standard Deviation|Mean
135058|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase|Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
135059|NCT00516321|Secondary|Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase|ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.|From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
135060|NCT00516321|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Baseline up to Week 12|ITT Population||participants|||Number
135061|NCT00516321|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.|From Baseline up to Week 12|ITT Population||participants|||Number
135062|NCT00516321|Secondary|Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase|The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|ITT Population||participants|||Number
135063|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the DB Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts.|DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.||Gi/L||Full Range|Median
135064|NCT00516321|Secondary|Median Platelet Count at the Indicated Time Points During the OL Phase|Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.|OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||Gi/L||Full Range|Median
135065|NCT00516321|Secondary|Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase|In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.|From Baseline up to Week 9 in the OL Phase|Safety Population. Participants with a platelet count >=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.||participants|||Number
135066|NCT00516321|Secondary|Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase|Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in the OL Phase|Safety Population: all participants who had received study drug in the OL Phase||participants|||Number
135067|NCT00516321|Primary|Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.|From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)|Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase||participants|||Number
135068|NCT00516295|Primary|Time to Disease Progression in Patients Receiving VTC With or Without Bevacizumab|Time from enrollment to disease progression, death, second malignant neoplasm, or last patient follow-up whichever occurs first. Patients who experience disease progression, death or second malignant neoplasm will be considered to have experienced an event; otherwise the patient will be considered censored at last follow-up.|Maximum of 5 years after enrollment|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.||days of event free survival||95% Confidence Interval|Median
135069|NCT00516295|Primary|The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient.|Limiting toxicity defined as Any Grade IV hematological toxicities lasting longer than 7 days, myelosuppression causing delays > 14 days in delivery of therapy, > Grade 3 thromboembolic events, > Grade 3 bleeding events, > Grade 2 hypertension, > Grade 2 proteinuria.|First 2 courses (42 days) of therapy|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.||number of toxicities|||Number
135070|NCT00516269|Primary|Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement|"The primary endpoint is the “fatigue worst” score (range: 0 – 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). Worst fatigue is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in “fatigue worst” score between post-Methylphenidate measurement and post-Placebo measurement."|At end of two 2-week treatment cycles (4 weeks total)|It is a crossover design and only the 33 patients who completed the study were included in the final data analysis.||units on a scale||Standard Deviation|Mean
135071|NCT00516217|Secondary|6 Month Progression Free Survival Rate|"Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.~Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node."|6 months|||percentage of participants||95% Confidence Interval|Number
135072|NCT00516217|Secondary|12 Month Overall Survival Rate|Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.|12 months|||percentage of participants||95% Confidence Interval|Number
135073|NCT00516217|Primary|Overall Response|"Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.~CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions."|Duration of treatment (up to 10 years)|||participants|||Number
135074|NCT00516165|Secondary|Overall Survival|The median overall survival was 8.4 months (95% CI, 3.9-21.1 months). Only 2 ((8 %) patients were progression-free at 24 weeks. The study did not proceed to the second stage of the phase 2 portion of the study.|2 years|||months||95% Confidence Interval|Median
135075|NCT00516165|Secondary|Time to Progression|3.9 months with a CI of 21-|2 years|||month||95% Confidence Interval|Median
135076|NCT00516165|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||percentage of patient response||95% Confidence Interval|Number
135077|NCT00516165|Secondary|Number of Patients With Adverse Events Who Were Treated With RAD001 for Advanced HCC|Everolimus given at 10 mg/day as a single agent was well tolerated in patients with advanced HCC.|2 years|Patients with histologically confirmed measurable advanced HCC. The primary end points were determination of a safe dosage of everolimus and progression-free survival at 24 weeks.||Participants|||Count of Participants
135078|NCT00516165|Primary|Progression-free Survival Rate at 24 Weeks|"Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~This information will be collected during two years of patient participation."|2 years|||months||95% Confidence Interval|Median
135079|NCT00516165|Primary|Maximum Tolerated Dose of RAD001 in Patients With Advanced Hepatocellular Carcinoma (HCC).||2 years|Patients with histologically confirmed measurable advanced Hepatocellular Carcinoma.||mg|||Number
135080|NCT00516139|Secondary|Absorption Rate (KA) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. KA is defined as the rate at which a drug enters the body after administration. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||1/h||95% Confidence Interval|Mean
135081|NCT00516139|Secondary|Apparent Volume of Distribution (V/F) for Participants in All Concomitant AED Groups Combined: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. V/F is defined as the apparent volume in which a drug is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to CPDM by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||liters||95% Confidence Interval|Mean
135082|NCT00516139|Secondary|Apparent Clearance (CL/F) Based on the Concomitant AED Groups: Neutral, With EIAED, and With VPA|Individual serum LTG concentration data were subjected to population pharmacokinetic methodologies based on the concomitant AED groups. Clearance is defined as the volume of LTG per unit time eliminated from serum. Serum LTG concentration-time data files incorporating, where appropriate, records of LTG administration, participant demography, and concomitant medication were supplied to Clinical Pharmacokinetics Modelling and Simulation, Clinical Pharmacology, and Discovery Medicine (CPDM) by Clinical Data Management as NONMEM compatible .csv files.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||Liters per hour||95% Confidence Interval|Mean
135083|NCT00516139|Secondary|Serum LTG Concentrations at Different LTG Doses Based on the Concomitant AED Groups: Neutral (Without Known Enzyme-inducing AED [EIAED], Valproate [VPA]) With EIAED, and With VPA|The blood samples were collected at the specified study visits; however, serum LTG concentrations were summarized by dose regimen, not by study week. The serum was assayed for LTG using an approved method under the management of Worldwide Bioanalysis, GlaxoSmithKline.|Weeks 4, 7, 11, 15, 20, 24, and 28|Safety Population. Participants with missing data were not analyzed. Not all participants received all doses at each blood draw; therefore, participants were only analyzed for the dose received at blood draw.||Micrograms per milliliter|serum concentrations|Full Range|Median
135084|NCT00516139|Secondary|Change From Baseline in Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Glucose, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of cholesterol, HDL cholesterol, LDL cholesterol, glucose, potassium, sodium, triglycerides, and urea/BUN at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||millimoles (mmol) per liter||Full Range|Median
135085|NCT00516139|Secondary|Change From Baseline in Direct Bilirubin (DB), Total Bilirubin (TB), and Creatinine at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of DB, TB, and creatinine at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||micromoles (µmol) per liter||Full Range|Median
135086|NCT00516139|Secondary|Change From Baseline in Alkaline Phosphatase (Alk P), Alanine Amino Transferase (Ala AT), and Aspartate Amino Transferase (Asp AT) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of Alk P, Ala AT, and Asp AT at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||International units per liter||Full Range|Median
135087|NCT00516139|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of RBC count at the indicated time points in the study from the Baseline value. Change from baseline is measured as the number of red blood cells x 10^12 per liter.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Tera (10^12) cells per liter||Full Range|Median
135088|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points in the the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCV at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Femtoliters||Full Range|Median
135181|NCT00515463|Secondary|Monocytes Change From Baseline at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
135089|NCT00516139|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of MCH at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||picograms||Full Range|Median
135090|NCT00516139|Secondary|Change From Baseline in the Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin, and Total Protein at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the values of MCHC, albumin, and total protein at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||grams per liter||Full Range|Median
135091|NCT00516139|Secondary|Percent Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count, Platelet Count, and White Blood Cell Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Percent change from Baseline = (value at each indicated time point in the study minus respective Baseline value divided by Baseline value) x 100.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Percent change in counts||Full Range|Median
135092|NCT00516139|Secondary|Change From Baseline in the Basophil, Eosinophil, Hemoglobin, Lymphocyte, Monocyte, Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points in the Study|The blood samples collected at the study visits were analyzed and assessed at the central laboratory, and the investigator reviewed and assessed the clinical significance. Change from Baseline was calculated by subtracting the value of basophil, eosinophil, hemoglobin, lymphocyte, monocyte, ANC, platelet count, and WBC count at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), and Week 28 (WD)|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Giga (10^9) cells per liter||Full Range|Median
135093|NCT00516139|Secondary|Change From Baseline in the Weight at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of weight measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||kilograms||Standard Deviation|Mean
135094|NCT00516139|Secondary|Change From Baseline in the Height at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the value of height measured by the investigator at the indicated time points in the study from the Baseline value.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||centimeters||Standard Deviation|Mean
135095|NCT00516139|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points in the Study|Change from Baseline was calculated by subtracting the values of systolic and diastolic blood pressures recorded by the investigator at the indicated time points in the study from the respective Baseline values.|Baseline (Week 0) and Week 15 (Adj M Phase), Week 28 (Adj O Phase), Week 28 (Mono Phase), Week 28 (WD), and Week 30/33 (End of study [EOS])|Safety Population. Only those participants with both a baseline and post-baseline value were analyzed.||Millimeters of mercury||Standard Deviation|Mean
135096|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Overall Clinical Status in the Indicated Categories, as Measured by the IGE Scale|Investigators rated the participants' overall clinical status at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Participants with missing data were not analyzed.||participants|||Number
135097|NCT00516139|Secondary|Number of Participants With Changes From Baseline in Seizure Severity in the Indicated Categories, as Measured by the Investigator's Global Evaluation (IGE) Scale|Investigators rated the participants' seizure severity at Weeks 15 and 28 of the study treatment by using the IGE scale, comprised of 7 categories: 3 for improvement (mild improvement, moderate improvement, and marked improvement), 3 for deterioration (marked deterioration, moderate deterioration, mild deterioration), and 1 for no change. Investigators assessed the degree of the participants' improvement or deterioration or determined whether the participants’ condition had not changed compared to their Baseline condition.|Week 15 (Adjunctive Maintenance [Adj M] Phase), Week 28 (Adjunctive Optimization [Adj O] Phase), Week 28 (Monotherapy [Mono] Phase), and Week 28 (Early Withdrawal [WD])|Safety Population. Only those participants who had seizures at baseline were analyzed.||participants|||Number
135098|NCT00516139|Secondary|Number of Seizure-free Participants at Baseline Who Remained Seizure-free Throughout the Entire Treatment Period|Participants were considered to be seizure-free if they did not report any seizures at Baseline.|Week 30 or 33|Safety Population. Participants who were seizure-free at Baseline were analyzed.||participants|||Number
135118|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24|Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are 'possibly', probably', or definitely' related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading.|From week 12 to week 24|||participants|||Number
135099|NCT00516139|Secondary|Number of Participants With the Indicated Change From Baseline in Weekly Seizure Frequency During Each Phase of the Study|Participants recorded the number of seizures, by seizure type, as well as the duration of episodes of innumerable seizure activity in their daily diaries during all phases of the study. For participants who withdrew from the study, seizure data were averaged for the portion of the study the participant completed up to the time of study drug discontinuation. Participants who experienced a change from Baseline in the weekly seizure frequency were categorized as having a >=25%, >=50%, >=75%, or 100% reduction or a >=50% increase in percent change from Baseline in weekly seizure frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization (Adj O) Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (ET, Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.||participants|||Number
135100|NCT00516139|Secondary|Percent Change From Baseline (BL) in Weekly Seizure (sz.) Frequency for All Partial Seizures During Each Phase of the Study|Partial-onset sz. have a focal site of onset; sz. activity is initially limited to 1 brain hemisphere. Partial sz. can remain simple or complex, or evolve to generalized tonic-clonic sz. Participants (par.) recorded the number of sz., by type as well as the episode duration of innumerable sz. activity), in daily diaries. If par. withdrew from study, data were averaged for the study portion the par. completed up to the time of drug discontinuation. Percent change from BL = (BL value minus study phase value divided by BL value) x 100; positive values indicate reduction from BL in sz. frequency.|Baseline (Week 0), Dose-Escalation Phase (Week 7), Maintenance Phase (Week 15), Adjunctive Optimization Phase (Week 28), Conversion Phase (Week 20), Monotherapy Phase (Week 28), and end of treatment (Week 30 or 33)|Safety Population. Only those participants who had seizures at baseline were analyzed.||Percent change in seizure frequency||Full Range|Median
135101|NCT00516139|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.|From Baseline (Week 0) until 3 weeks after the end of treatment (Week 30 or 33)|Safety Population: all participants who were enrolled and took at least one dose of study drug||participants|||Number
135102|NCT00516074|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change from baseline to endpoint in HbA1c|12 weeks|Intent to treat; Last observation carried forward||percent||Standard Error|Least Squares Mean
135103|NCT00516074|Secondary|Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||mmHg||Standard Error|Least Squares Mean
135104|NCT00516074|Secondary|Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint|Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||mmHg||Standard Error|Least Squares Mean
135105|NCT00516074|Secondary|Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||beats per minute||Standard Error|Least Squares Mean
135106|NCT00516074|Secondary|Change in Daytime Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor|12 weeks|Intent to treat; Last observation carried forward||beats per minute||Standard Error|Least Squares Mean
135107|NCT00516074|Primary|Change in Mean 24-hour Heart Rate From Baseline to Endpoint|Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.|12 weeks|Intent to treat; Last observation carried forward||beats per minute||Standard Error|Least Squares Mean
135108|NCT00516048|Primary|Incidence of Potentially Immune-related Treatment-emergent Adverse Events|Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study|24 weeks|Intent to Treat||participants|||Number
135109|NCT00516048|Secondary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint|Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status|24 weeks|Intent to Treat; Last Observation Carried Forward||percent||Standard Deviation|Mean
135110|NCT00516048|Primary|Treatment-emergent Antibody Status (Maximum Titer Level Experienced)|Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)|24 weeks|Intent to Treat||Participants|||Number
135111|NCT00515879|Secondary|Range of Impaired Functioning Tool||Measured at Months 3, 6, and 9 post-treatment||||||
135112|NCT00515879|Secondary|Liebowitz Self-Rated Disability Scale||Measured at Months 3, 6, and 9 post-treatment||||||
135113|NCT00515879|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire||Measured at Months 3, 6, and 9 post-treatment||||||
135114|NCT00515879|Secondary|Social Phobia and Anxiety Inventory||Measured at Months 3, 6, and 9 post-treatment||||||
135115|NCT00515879|Primary|Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum).|Measured at Months 3|||LSAS scores||95% Confidence Interval|Mean
135116|NCT00515879|Primary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration).|Measured at Months 3 (immediately after treatment)|||Units on a scale||95% Confidence Interval|Mean
135119|NCT00515827|Secondary|Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12|"Participant who experienced at least one study related grade 2 or higher signs/symptoms, grade 3 or higher laboratory abnormalities and clinical events that are possibly, probably or definitely related to study treatment. DAIDS Toxicity Grading Table (2004) was used for grading."|From first day of treatment to week 12|All participants on study treatment||Participant|||Number
135120|NCT00515827|Secondary|Change in CD8+/CD38+/HLA-DR+ Percent|Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who stayed on study treatment and had not experienced virologic failures.||% CD8 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
135121|NCT00515827|Secondary|Change in CD4+/CD38+/HLA-DR+ Percent|Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD4+/CD38+/HLA-DR+% at week 12 minus CD4+/CD38+/HLA-DR+% at baseline.|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure||% CD4 cells co-express CD38+ and HLA-DR+||Inter-Quartile Range|Median
135122|NCT00515827|Secondary|Change in Total CD8 Cell Count|CD8 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure||cells/mm^3||Inter-Quartile Range|Median
135123|NCT00515827|Secondary|Change in Total CD4 Cell Count|CD4 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12|At pre-entry, entry, and week 12|All participants who were on study treatment and had not experienced virologic failure||cells/mm^3||Inter-Quartile Range|Median
135124|NCT00515827|Secondary|Change in HIV-1 RNA Level|Change in HIV-1 RNA level, as measured by single copy assay, from baseline to weeks 10/12 . When averaging the measurements at pre-entry and entry, and at weeks 10 and 12, measurements below the lower limit of quantification (LLQ) were imputed a value of the LLQ divided by 2.|At pre-entry, entry, weeks 10 and 12|All participants who were on study treatment and had not experienced virologic failure||copies/mL||Inter-Quartile Range|Median
135125|NCT00515827|Primary|HIV-1 RNA Level|HIV-1 RNA level, as measured by single copy assay, averaged at weeks 10 and 12. The quantification limit of single copy assay was determined by the volume of plasma tested. When averaging the week 10 and 12 measurements, if one of both measurements were below the single copy assay lower limits, the lower limit of quantification was used to compute the average and the result was treated as below the averaged value.|At Weeks 10 and 12|49 subjects who were on study treatment before week 10 and did not experience virologic failure by week 12||copies/mL||Inter-Quartile Range|Median
135126|NCT00515697|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to study completion (up to 34 months) plus 30-day safety follow-up|Intent-to-treat population: participants who received any quantity of ramucirumab.||participants|||Number
135127|NCT00515697|Secondary|Maximum Concentration (Cmax) of Ramucirumab||1 hour after the end of the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
135128|NCT00515697|Secondary|Minimum Concentration (Cmin) of Ramucirumab||Immediately prior to the Week 32 infusion treatment [Cycle 16 (1 cycle=14 days)]|Participants who received any quantity of ramucirumab and had evaluable pharmacokinetic data at the specified time point.||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
135129|NCT00515697|Secondary|Median Duration of Overall Response|Duration of response is the interval from the date of initial documented response [confirmed complete response (CR) or partial response (PR)] to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data from participants who did not relapse were censored on the day of their last tumor assessment.|Time of first response (CR or PR) to disease progression, initiation of other (or additional) antitumor therapy, or death due to any cause (up to 34 months)|Participants who received any quantity of ramucirumab and had confirmed complete response or partial response. The number of participants censored was 1.||months||95% Confidence Interval|Median
135130|NCT00515697|Secondary|Percentage of Participants With Objective Response (Objective Response Rate) at 12 Weeks|The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at Week 12, as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved at 12 weeks was CR or PR/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.||percentage of participants||95% Confidence Interval|Number
135182|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
135131|NCT00515697|Secondary|Percentage of Participants Showing Disease Control at Week 12|Participants who were alive and did not experience disease progression were considered to have disease control at 12 weeks. Disease control was based on lack of disease progression using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. According to RECIST criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or detection of new lesion. Participants whose disease progression was symptomatic were not considered to have disease control. The percentage of participants showing disease control=(number of participants who did not have disease or symptomatic progression at Week 12/number of participants treated)*100.|Week 12 [Cycle 6 (1 cycle=14 days)]|Intent-to-treat population: participants who received any quantity of ramucirumab.||percentage of participants||95% Confidence Interval|Number
135132|NCT00515697|Secondary|Progression-Free Survival|Progression-free survival (PFS) is measured from the date of the first dose to the first documented date of disease progression as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria or death from any cause. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data for participants whose disease does not progress or for whom no post-baseline assessment is made are censored at the day of their last tumor assessment. Data for participants whose disease does not progress who are subsequently lost to follow-up are also censored at the day of their last tumor assessment.|First dose to measured progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab. The number of participants censored was 4.||months||95% Confidence Interval|Median
135133|NCT00515697|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|The percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) as classified according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR is the disappearance of all target and non-target lesions and normalization of tumor marker levels. PR is having at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. The percentage of participants with objective response=(number of participants whose best overall response during therapy is CR or PR/number of participants treated)*100.|First dose to date of objective progressive disease or death due to any cause (up to 34 months)|Intent-to-treat population: participants who received any quantity of ramucirumab.||percentage of participants||95% Confidence Interval|Number
135134|NCT00515671|Secondary|Psychiatric Symptoms (PANSS Total)|Psychiatric symptomatology was assessed by the Positive and Negative Syndrome Scale (PANSS), a widely-used, 30-item rating scale. The PANSS has previously demonstrated satisfactory internal consistency, test-retest reliability, and validity. Raters were trained to reach inter-rater agreement of .80 prior to interviewing participants. This is the total score, which ranges from 30 to 210, with higher scores indicating more severe symptoms.|Baseline, 9 months, 18 months|||units on a scale||Standard Deviation|Mean
135135|NCT00515671|Primary|Illness Management Ratings|Illness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.|Baseline, 9 months, 18 months|||units on a scale||Standard Deviation|Mean
135136|NCT00515619|Secondary|Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)|At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency|Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.||Percentage of subjects|||Number
135137|NCT00515619|Secondary|Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)|"Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.~Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency."|Baseline, Treatment Period (up to 5.5 years)|Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.||Percentage change||Full Range|Median
135138|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||Subjects|||Number
135139|NCT00515619|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||Subjects|||Number
135140|NCT00515619|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|During the Treatment Period (up to 5.5 years)|Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.||Subjects|||Number
135141|NCT00515541|Primary|EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid|Measurements were made using a modified device (EQELS) to specifications of constant current, high electric field and a scattering angle of 30 degrees. EQELS provides a sensitive assessment of subtle changes in the cell surface that occurs with activation, ligand binding or apoptosis. These changes are the result of different distributions of charged groups that define a surface charge finger print for the current state of activation of the cell. Resting state platelets have a negative surface charge, whereas fully activated platelets have a positive surface charge.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks. Change in EQELS value after the addition of Arachidonic Acid.||mobility units||Inter-Quartile Range|Median
135142|NCT00515541|Primary|Bleeding Time|Bleeding time is a measure of how well platelets interact with blood vessel walls to form a clot. A manual blood pressure cuff is placed 2 inches above the antecubital fossa and inflated to 40mmHg. Using a standard Surgicutt device, a small incision is made and a stopwatch is started. The incision edge is blotted at 30 second intervals with standard filter paper until the bleeding has stopped. The time to hemostasis is noted.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks||seconds||Inter-Quartile Range|Median
135143|NCT00515541|Secondary|The Occurence of Any Type of Bleeding|was there any bleeding occurance during the accessed interval|up to and including closeout at 24 weeks|Subjects would indicate if they had any bleeding episode during the trial at each of their testing intervals||Number of occurance|||Number
135144|NCT00515541|Primary|Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.)|The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.|up to and including closeout at 24 weeks|Based on number of subjects completing 24 weeks||percent||Inter-Quartile Range|Median
135145|NCT00515502|Secondary|Mean Serial Specific Airway Resistance (sGaw) Over 24 Hours After Dosing on Day 1 of Each Treatment Period|sGaw is the specific airways resistance (mid) which was assessed by whole body plethysmography. Values used were the mean of the 3 readings recorded at each timepoint. sGaw measurements were taken at 2 hour (h), 6 h, 12 h and 24 h post-dose of each treatment period. 1/kPa.s=1(the inverses)/kPa (kilopascal).s (second)|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||1/kPa*s||Standard Error|Geometric Mean
135146|NCT00515502|Secondary|Mean Serial FEV1over 24 Hours After Dosing on Day 1 of Each Treatment Period|Serial spirometry assessments were conducted on Day 1 of each treatment period over the course of 24 hours and were taken at 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose. The maximum of the 3 FEV1 measurements for each participant, treatment period and timepoint were used in the calculation of the mean for each treatment group at each timepoint.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Error|Least Squares Mean
135147|NCT00515502|Secondary|Fraction of Dose Excreted Unchanged in Urine From Time Zero to: 24 Hours [Fe(0-24)] and 48 Hours [Fe(0-48)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Fe(0-24) and Fe(0-48). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||Percentage of total dose administered||Full Range|Median
135148|NCT00515502|Secondary|Half-life for Renal Excretion of UMEC on Day 1|The terminal half-life (t1/2) of UMEC is defined as the time required for the urine concentration of UMEC to reach half of its original concentration. Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||Hours||Geometric Coefficient of Variation|Geometric Mean
135149|NCT00515502|Secondary|Renal Clearance (CLr) of UMEC Following Dose Administration on Day 1|The CLr is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
135150|NCT00515502|Secondary|Amount of Drug Excreted Unchanged in Urine From Time Zero to: 2h [Ae(0-2)] , 8h [Ae(0-8)], 12h [Ae(0-12)], 24h [Ae(0-24)], and 48h [Ae(0-48)]; and Area Under the Excretion Rate Curve From Time Zero to: 18h [AUER(0-18)] and 36h [AUER(0-36)] for UMEC|Urine samples were collected to determine the urine concentrations of UMEC from 0 min up to 48 hours post-dose of each treatment period to derive Ae(0-2), Ae(0-8), Ae(0-12), Ae(0-24), Ae(0-48), AUER(0-18) and AUER(0-36). Urine samples for PK analysis of UMEC were obtained on Day 1; a single sample was collected at each of the following timepoints: 0–2 h, 2–8 h, 8–12 h, 12–24 h and 24–48 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||ng||Geometric Coefficient of Variation|Geometric Mean
135163|NCT00515502|Primary|Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Grams per liter (G/L)||Standard Deviation|Mean
135183|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
135151|NCT00515502|Secondary|Time of Maximum Observed Plasma Concentration (Tmax), Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast), and Plasma Half-life (t1/2) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive tmax, tlast and t1/2. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population. Only those participants with non-missing observations (including non-calculable values) were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the PK Population||Hours||Full Range|Median
135152|NCT00515502|Secondary|Maximum Observed Plasma Concentration (Cmax) of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the Cmax. Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|PK Population||ng/mL||Geometric Coefficient of Variation|Geometric Mean
135153|NCT00515502|Secondary|Area Under Concentration-time Curve From Time 0 to 2 Hours [AUC(0-2)] and Area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-t)] of UMEC|Blood samples were collected to determine the plasma concentrations of UMEC from pre-dose up to 24 hour post-dose of each treatment period to derive the AUC(0-2) and AUC(0-t). Blood samples for PK analysis of UMEC were obtained on Day 1at pre-dose and 5 minutes (min), 15 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 8 h, 12 h, 16 h, and 24 h post UMEC dose administration.|Day 1 of each treatment period (up to Study Day 46)|Pharmacokinetic (PK) Population:all participants in the All Subjects Population for whom a PK sample was obtained and analyzed.||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
135154|NCT00515502|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC measurements were taken at pre-dose and 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Liters||Standard Deviation|Mean
135155|NCT00515502|Primary|Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the calcium, bicarbonate, chloride, glucose, IP, potassium, sodium, and urea at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||Millimoles per liter (mmol/L)||Standard Deviation|Mean
135156|NCT00515502|Primary|Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Micromoles per liter (µmol/L)||Standard Deviation|Mean
135157|NCT00515502|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, and GGT at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.||International units per liter (IU/L)||Standard Deviation|Mean
135158|NCT00515502|Primary|Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of platelets count and WBC count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||10^9 cells per liter (GI/L)||Standard Deviation|Mean
135159|NCT00515502|Primary|Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the red blood cells count at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||10^12 cells per liter (TI/L)||Standard Deviation|Mean
135160|NCT00515502|Primary|Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle volume at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Femtoliters (FL)||Standard Deviation|Mean
135161|NCT00515502|Primary|Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of the mean corpuscle hemoglobin at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||picograms/cell (pg)||Standard Deviation|Mean
135162|NCT00515502|Primary|Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit at pre-dose and 24 hour (h) post-dose of each treatment period.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population||Proportion of red blood cells in blood||Standard Deviation|Mean
148569|NCT00399542|Secondary|Month 3 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF||SBMs/week||Standard Deviation|Mean
135165|NCT00515502|Primary|Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four-hour Holter monitoring was conducted to measure heart rate for the 24-h period following dosing of each treatment period and the mean value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
135166|NCT00515502|Primary|Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period|Twenty-four hour Holter monitoring was conducted to measure heart rate for the 24-hour period following dosing at each treatment period and the maximum value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
135167|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcF at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
135168|NCT00515502|Primary|Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QT interval corrected according to Fredericia’s formula (QTcF) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
135169|NCT00515502|Primary|Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs were performed to measure QTcB at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
135170|NCT00515502|Primary|Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period|Twelve-lead ECGs (electrocardiograms) were performed to measure QT interval corrected according to Bazzet's formula (QTcB) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Milliseconds (msec)||Standard Error|Least Squares Mean
135171|NCT00515502|Primary|Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
135184|NCT00515463|Secondary|Lymphocytes Change From Baseline at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
148570|NCT00399542|Secondary|Month 2 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF||SBMs/week||Standard Deviation|Mean
135172|NCT00515502|Primary|Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period|Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
135173|NCT00515502|Primary|Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
135174|NCT00515502|Primary|Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period|Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
135175|NCT00515502|Primary|Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for heart rate (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
135176|NCT00515502|Primary|Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period|Resting heart rate was measured at pre-dose and 15 minutes (min), 45min, 1.5 hour (h) 4 h, 8 h, and 24 h post-dose of each treatment period and the maximum value for heart rate (0-4hours) was derived at rest. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.|Day 1 of each treatment period (up to Study Day 46)|All Subjects Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 1.||Beats per minute (bpm)||Standard Error|Least Squares Mean
135177|NCT00515502|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)|All Subjects Population: all participants who received at least one dose of study medication.||Participants|||Number
135178|NCT00515463|Secondary|Number of Participants With Laboratory Toxicity CTCAE Grade Greater or Equal to 3|Participants with laboratory toxicity grade 3 (severe) or 4 (life-threatening), based on the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Day 1 to Month 12|Patients who received ≥ 1 dose of investigational product.||Participants|||Number
135179|NCT00515463|Secondary|Monocytes Change From Baseline at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
135180|NCT00515463|Secondary|Monocytes Change From Baseline at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
135191|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
135192|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
135193|NCT00515463|Secondary|Total Neutrophils Change From Baseline at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
135194|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
135195|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
135196|NCT00515463|Secondary|White Blood Cells Change From Baseline at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
135197|NCT00515463|Secondary|Platelets Change From Baseline at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
135198|NCT00515463|Secondary|Platelets Change From Baseline at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
135199|NCT00515463|Secondary|Platelets Change From Baseline at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
135200|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 12|Laboratory hematology reticulocytes|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^9/L||Standard Deviation|Mean
135201|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 6|Laboratory hematology reticulocytes|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^9/L||Standard Deviation|Mean
135202|NCT00515463|Secondary|Reticulocytes Change From Baseline at Month 1|Laboratory hematology reticulocytes|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^9/L||Standard Deviation|Mean
135203|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||g/L||Standard Deviation|Mean
135204|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||g/L||Standard Deviation|Mean
135205|NCT00515463|Secondary|Hemoglobin Change From Baseline at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||g/L||Standard Deviation|Mean
135206|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||10^12/L||Standard Deviation|Mean
135207|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||10^12/L||Standard Deviation|Mean
135208|NCT00515463|Secondary|Red Blood Cells Change From Baseline at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||10^12/L||Standard Deviation|Mean
135209|NCT00515463|Secondary|Glucose Change From Baseline at Month 12|Laboratory chemistry glucose|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
135210|NCT00515463|Secondary|Glucose Change From Baseline at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
135211|NCT00515463|Secondary|Glucose Change From Baseline at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
135212|NCT00515463|Secondary|Total Protein Change From Baseline at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||g/L||Standard Deviation|Mean
135213|NCT00515463|Secondary|Total Protein Change From Baseline at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||g/L||Standard Deviation|Mean
135214|NCT00515463|Secondary|Total Protein Change From Baseline at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||g/L||Standard Deviation|Mean
135215|NCT00515463|Secondary|Albumin Change From Baseline at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||g/L||Standard Deviation|Mean
135216|NCT00515463|Secondary|Albumin Change From Baseline at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||g/L||Standard Deviation|Mean
135217|NCT00515463|Secondary|Albumin Change From Baseline at Month 1|Laboratory chemistry albumin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||g/L||Standard Deviation|Mean
135218|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||umol/L||Standard Deviation|Mean
135219|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||umol/L||Standard Deviation|Mean
135220|NCT00515463|Secondary|Total Bilirubin Change From Baseline at Month 1|Laboratory chemistry total bilirubin|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||umol/L||Standard Deviation|Mean
135221|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||U/L||Standard Deviation|Mean
135222|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||U/L||Standard Deviation|Mean
135223|NCT00515463|Secondary|Alanine Amino Transferase Change From Baseline at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||U/L||Standard Deviation|Mean
135224|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||U/L||Standard Deviation|Mean
135225|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 6|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||U/L||Standard Deviation|Mean
135226|NCT00515463|Secondary|Aspartate Amino Transferase Change From Baseline at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||U/L||Standard Deviation|Mean
135227|NCT00515463|Secondary|Creatinine Change From Baseline at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||umol/L||Standard Deviation|Mean
135228|NCT00515463|Secondary|Creatinine Change From Baseline at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||umol/L||Standard Deviation|Mean
135229|NCT00515463|Secondary|Creatinine Change From Baseline at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||umol/L||Standard Deviation|Mean
135230|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 12|Laboratory chemistry blood urea nitrogen|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
135231|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
135232|NCT00515463|Secondary|Blood Urea Nitrogen Change From Baseline at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
135233|NCT00515463|Secondary|Magnesium Change From Baseline at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
135234|NCT00515463|Secondary|Magnesium Change From Baseline at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
135235|NCT00515463|Secondary|Magnesium Change From Baseline at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
135236|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 12|Laboratory chemistry bicarbonate|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
135237|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
135238|NCT00515463|Secondary|Bicarbonate Change From Baseline at Month 1|Laboratory chemistry bicarbonate|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
135239|NCT00515463|Secondary|Chloride Change From Baseline at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
135240|NCT00515463|Secondary|Chloride Change From Baseline at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
135241|NCT00515463|Secondary|Chloride Change From Baseline at Month 1|Laboratory chemistry chloride|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
135242|NCT00515463|Secondary|Potassium Change From Baseline at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
135243|NCT00515463|Secondary|Potassium Change From Baseline at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
135245|NCT00515463|Secondary|Sodium Change From Baseline at Month 12|Sodium Change From Baseline at Month 12|Baseline, Month 12|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 12.||mmol/L||Standard Deviation|Mean
135246|NCT00515463|Secondary|Sodium Change From Baseline at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 6.||mmol/L||Standard Deviation|Mean
135247|NCT00515463|Secondary|Sodium Change From Baseline at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received ≥ 1 dose of investigational product with non-missing baseline and non-missing month 1.||mmol/L||Standard Deviation|Mean
135248|NCT00515463|Secondary|Number of Participants With Neutralizing Antibodies Against Denosumab at Month 12|Samples demonstrating reactivity for binding antibodies to denosumab were to be tested for neutralizing or inhibitory effects in a cell-based bioassay.|Month 12|Patients testing positive for binding antibodies to denosumab.|||||
135249|NCT00515463|Secondary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 12|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|12 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 12 months.||Participants|||Number
135250|NCT00515463|Primary|Number of Participants Who Tested Positive for Anti-denosumab Antibodies at Month 6|An electrochemiluminescent bridging immunoassay was used to test blood samples for binding antibodies to denosumab.|6 months|Patients who received ≥ 1 dose of investigational product, have a baseline and ≥ 1 post-baseline antibody assessment and did not have binding anti-denosumab antibodies present at baseline, and with evaluable antibody results at 6 months.||Participants|||Number
135251|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection|"saliva collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 12 weeks post-injection|||grams/minute||Standard Deviation|Mean
135252|NCT00515437|Secondary|Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection|"saliva is collected over 5 minutes and weighed to produce a grams/minute rate"|baseline vs 4 weeks post-injection|||grams/minute||Standard Deviation|Mean
135253|NCT00515437|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection|9 point scale (0=no drooling, 9=severe drooling)|baseline vs 12 weeks post injection|||points on a scale||Standard Deviation|Mean
135254|NCT00515437|Primary|Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection|9 point scale, 0 = no drooling, 9 = severe drooling|baseline versus 4 weeks post-injection|Intent to Treat (ITT)||points on a scale||Standard Deviation|Mean
135255|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
135256|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
135257|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
135258|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
135259|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
135260|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
135261|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had stable disease.|4 years|11 out of 25 participants had a partial response.||participants|||Number
135262|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the MDR1 c.3435C>T (rs1045642) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
135263|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the XRCC1 c.1196G>A (rs25487) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
135264|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the GSTP1 c.313A>G (rs1695) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
135265|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC2 c.2251A>C (rs13181) gene had a partial response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
135266|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the ERCC1 c.354C>T (rs11615) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
135267|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
135268|NCT00515216|Secondary|Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)|This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G>C (rs34743033) gene had a partial tumor response.|4 years|9 out of 25 participants had a partial response.||participants|||Number
135269|NCT00515216|Secondary|Tumor Specific Changes That May Alter Treatment Outcomes||4 years|This was not completed as the archived tumor samples were not of sufficient quality for DNA extraction or analysis.|||||
135270|NCT00515216|Secondary|Disease Control Rate (DCR)|"DCR - complete response, partial response, and stable disease~Complete response - disappearance of all target and non-target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Stable disease - neither sufficient shrinkage to qualify for partial response not sufficient increase to qualify for progressive disease"|2 years|||percentage of participants||95% Confidence Interval|Number
135271|NCT00515216|Secondary|Progression-free Survival (PFS)|Progressive disease - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|4 years|||months||95% Confidence Interval|Median
135272|NCT00515216|Secondary|Overall Survival||4 years|||months||95% Confidence Interval|Median
135273|NCT00515216|Primary|Overall Response Rate (ORR)|"ORR = complete response + partial response~Complete response - disappearance of all target and non-target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter"|2 years|||percentage of participants||95% Confidence Interval|Number
135274|NCT00515203|Primary|Adverse Events|Occurrence of one or more adverse events in the participant during the 12-week treatment period|12 weeks|Safety Analysis Set, composed of all participants who received at least one dose of study medication||Participants|||Number
135275|NCT00515203|Secondary|Requirement for Rescue Therapy (as Defined Per Protocol)|Participant required rescue therapy (as defined per protocol) during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Participants|||Number
135276|NCT00515203|Secondary|Increase in Platelet Count ≥ 20 x 10^9/L Above Baseline for Two Consecutive Weeks|Participant incidence of achieving an increase in platelet count ≥20 x 10^9/L above baseline for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Participants|||Number
135277|NCT00515203|Secondary|Platelet Count ≥ 50 x 10^9/L for Two Consecutive Weeks|Participant incidence of achieving a platelet count ≥50 x 10^9/L for two consecutive weeks during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Participants|||Number
135278|NCT00515203|Secondary|Bleeding Events (Grade 2 or Higher)|Total number of bleeding events (Grade 2 or higher, i.e., mild to life-threatening, as defined in the protocol) for each participant during Weeks 2-13 (end-of-study visit for non-responders)|12-week treatment period (Weeks 2 - 13)|Efficacy Analysis Set, composed of all randomized participants||Events per participant||Standard Deviation|Mean
135279|NCT00515203|Secondary|Weeks With Platelet Count ≥ 50 x 10^9/L|The number of weeks with platelet count ≥ 50 x 10^9/L during the 12 week treatment period.|12-week treatment period|Efficacy Analysis Set, composed of all randomized participants||Weeks||Standard Deviation|Mean
135280|NCT00515177|Secondary|Medical Outcome Study Short Form (SF-12)|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
135281|NCT00515177|Secondary|Center for Epidemiological Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
135282|NCT00515177|Secondary|State-Trait Anxiety Inventory (STAI)|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
135283|NCT00515177|Primary|Actigraphy|Total Sleep Time from Actigraphy|8 weeks|In the PCT arm, one person who refused to take the drug and one who did not complete actigraphy were excluded. 10-2=8 In the MBSR arm, one person who did not attend MBSR, one person who attended fewer than 5 classes, and two who did not complete actigraphy were excluded. 20-4=16.||hours||Standard Deviation|Mean
135284|NCT00515177|Primary|Insomnia Severity Index|The Insomnia Severity Index is a 7-item scale that provides a total score indicating current (e.g., last 2 weeks) severity of insomnia symptoms with scores that can range from 0 to 28. Scores of 15 or higher indicate clinical insomnia.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
135285|NCT00515177|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|8 weeks and 5 months|In the PCT arm, one person who refused to take the drug was excluded. 10-1=9 In the MBSR arm, one person who did not attend MBSR and one person who attended fewer than 5 classes were excluded. 20-2=18.||units on a scale||Standard Deviation|Mean
135286|NCT00515112|Secondary|To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.|The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.|every 8 weeks||||||
135297|NCT00515086|Secondary|Surgery Group: Biomarkers Phosphatase and Tensin Homolog (PTEN) and Epidermal Growth Factor Receptor (EGFR)|"The secondary efficacy assessment was to evaluate the role of PTEN and EGFR pathway status on phosphor-S6. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments. Immunohistochemistry and Fluorescence in-situ hybridization (FISH) were used to assess PTEN and EGFR pathway status.~Study was terminated due to slow enrollment. Analysis was not possible due to insufficient sample size."|After surgery, week 4, week 8 and every 8 weeks thereafter|Study was terminated due to slow enrollment.||Levels||Standard Deviation|Mean
135287|NCT00515112|Primary|Progression Free Survival|Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.|Up to 5 years|This study has been terminated due to poor accrual.|||||
135288|NCT00515099|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c of <\=5.6% is considered normal. HbA1c of 6.5% or higher is typical for individuals with Type 1 Diabetes mellitus (T1DM).|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat||Percentage (%)||Standard Deviation|Mean
135289|NCT00515099|Secondary|2-Hour and 4-Hour C-peptide Area Under the Curve (AUC) Results in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) and 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the CDER at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment), Month 24|Intent-to-treat||pmol/mL||Standard Deviation|Mean
135290|NCT00515099|Secondary|Number of Participants With Major Hypoglycemic Event(s) Post Treatment Randomization/Initiation|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline (Pre-treatment), Months 12 , and 24|Intent-to-treat||participants|||Number
135291|NCT00515099|Secondary|Number of Participants Who Are Exogenous-Insulin-Free|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 , 18, and 24|Intent-to-treat||participants|||Number
135292|NCT00515099|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use exogenous insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment), Months 12 and 24|Intent-to-treat||units/day/kg||Standard Deviation|Mean
135293|NCT00515099|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 4-hour (e.g., 240 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat||pmol/mL||Standard Deviation|Mean
135294|NCT00515099|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Month 12|Intent-to-treat||pmol/mL||Standard Deviation|Mean
135295|NCT00515086|Secondary|Surgery Group: Number of Participants With Adverse Events|The number of participants with any adverse event by System Organ Class. Additional information about Adverse Events can be found in the Adverse Event Section.|First day of treatment to study discontinuation (Up to 28 weeks)|Surgery Group participants from the Safety population who received at least one dose of study medication.||Participants|||Number
135296|NCT00515086|Secondary|No Surgery Group: Progression Free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS is reported for participants with 1 previous relapse and participants with ≥2 previous relapses. PFS was measured from the first day of treatment to disease progression or death and is derived using the Kaplan-Meier method.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.||Weeks||95% Confidence Interval|Median
135315|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Pharmacokinetic Set (PK)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
135298|NCT00515086|Secondary|Surgery Group: Progression-free Survival|Progression-free survival (PFS) was assessed using Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) and based on the Neuro-Oncology Criteria for Tumor Response for CNS tumors. PFS was measured from the first day of treatment after surgery to disease progression or death and is derived using the Kaplan-Meier method.|After surgery (within 96 hours), Weeks 4 and 8 and then every 8 weeks after restarting treatment until study discontinuation (Up to 28 weeks)|Results for the Surgery Group only include patients with residual tumor following salvage surgery.||Weeks||95% Confidence Interval|Median
135299|NCT00515086|Secondary|Surgery Group: Blood and Brain Tissue Levels of Everolimus (RAD001)||Baseline and Day 7-9 (Blood samples were collected one day prior to surgery and tissue samples were collected during surgery.)|Study was terminated due to slow enrollment.||Levels||Standard Deviation|Mean
135300|NCT00515086|Primary|No Surgery Group: Best Overall Tumor Response|The best overall tumor response is reported for participants with 1 previous relapse and participants with ≥2 previous relapses according to the following categories: Complete Response, Partial Response, Stable Disease and Progressive Disease. Gadolinium chelate-enhanced Magnetic Resonance Imaging (MRI) was used for tumor analysis. The objective assessment of tumor response was evaluated at each site by the designated pathologist based on the Neuro-Oncology criteria for Tumor Response for Central Nervous System (CNS) tumors.|First day of treatment to study discontinuation (up to 60 weeks)|No Surgery Group participants from the Intent-to-treat (ITT) population who received at least one dose of study medication.||Participants|||Number
135301|NCT00515086|Primary|Surgery Group: Percentage Change From the Baseline in S6 Kinase Levels|In the Surgery Group, the primary efficacy assessment was inhibition of Mammalian target of rapamycin (mTOR) as defined as ≥75% S6 phosphorylation. The occurrence of S6 phosphorylation was determined by phosphor-S6 immunohistochemical staining. Tumor cells from the initial surgical resection and from the salvage resection were used for assessments.|Baseline and Day 7-9 (during salvage surgery)|Study was terminated due to slow enrollment.||Percentage change in S6 kinase|||Number
135302|NCT00515073|Primary|Overall Survival at 2 Years and 5 Years|The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.|Assessment at 2 years and 5 years|Two participants were inevaluable.||percentage of participants|||Number
135303|NCT00515034|Secondary|Patients With cIAI Who Were Clinically Cured|clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.|7 to 14 days after the end of IV therapy|participants who were clinically evaluable||participants|||Number
135304|NCT00515034|Secondary|Patients With VAP Who Were Clinically Cured|clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.|7 to 14 days after the end of IV therapy|the population is the number of participants who are clinically evaluable||participants|||Number
135305|NCT00515034|Primary|Patients With Incidence of Treatment-emergent Adverse Events (TEAEs).|Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.|from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy|population is the as-treated analysis set - that is subjects who were administered therapy||participants|||Number
135306|NCT00515008|Secondary|Mean Change From Baseline CPSS Score|The Chronic Pain Self-Efficacy Scale (CPSS) is a self-report score measuring self-efficacy with respect to chronic pain (range, 1 to 10, with higher scores indicating greater self-efficacy).|12 weeks|||units on a scale||95% Confidence Interval|Mean
135307|NCT00515008|Secondary|Mean Change From Baseline CES-D Score|The Center for Epidemiologic Studies (CES-D) Depression Scale (range, 0 to 60, with higher scores indicating more severe depression), is a self-report measure of depressive symptoms.|12 weeks|||units on a scale||95% Confidence Interval|Mean
135308|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Mental Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks|||units on a scale||95% Confidence Interval|Mean
135309|NCT00515008|Secondary|Mean Change From Baseline SF-36 Score Physical Component|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|12 weeks|||units on a scale||95% Confidence Interval|Mean
135310|NCT00515008|Secondary|Mean Change From Baseline of 6-Minute Walk Test||12 weeks|||yards||95% Confidence Interval|Mean
135311|NCT00515008|Secondary|Mean Change From Baseline PSQI Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality(range, 0 to 21, with higher scores indicating worse sleep quality)|12 weeks|||units on a scale||95% Confidence Interval|Mean
135312|NCT00515008|Secondary|Mean Change From Baseline of Patient’s Global Assessment Score|Patients' global assessment score was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|12 weeks|||units on a scale||95% Confidence Interval|Mean
135313|NCT00515008|Secondary|Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity|Physicians' global assessment score was assessed separately by the study physician, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|Wks 12|||units on a scale||95% Confidence Interval|Mean
135314|NCT00515008|Primary|Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score|Fibromyalgia Impact Questionnaire (FIQ) is a well-validated, multidimensional measure of the overall severity of fibromyalgia as rated by patients. Categories include the intensity of pain, physical functioning, fatigue, morning tiredness, stiffness, depression, anxiety, job difficulty, and overall well-being.21 The total score ranges from 0 to 100, with higher scores indicating more severe symptoms.|wks 12|||units on a scale||95% Confidence Interval|Mean
135524|NCT00513071|Secondary|Progression-free Survival (PFS) According to RECIST|PFS defined as time between registration and disease progression or death. Using the method of Kaplan-Meier.|Up to 2 years|||Months||95% Confidence Interval|Median
135316|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29)|"Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.~Note: At day 29, values for afatinib 40 mg no values reported in stage 2."|Day 29|Pharmacokinetic Set (PK)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
135317|NCT00514943|Secondary|Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15)|"Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.~Note: At day 15, values for afatinib 40 mg no values reported in stage 1 and stage 2."|Day 15|Pharmacokinetic Set (PK): The PK analysis was based on all patients who were treated with afatinib and who had evaluable plasma concentration data, which consisted of data for 60 patients in Stage 1 and 35 patients in Stage 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
135318|NCT00514943|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.||percentage of participants|||Number
135319|NCT00514943|Secondary|Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function|"Patients with adverse events (AEs) resulting in Diarrhea, Skin Rash, dose reduction, treatment discontinuation and decreased cardiac left ventricular function~Note: To asses the Decreased Cardiac left ventricular function, Left ventricular ejection fraction (LVEF) was assessed in patients treated with afatinib in Stage 1 and Stage 2 . And no patients in either group had a significant change in LVEF during Stage 1 or Stage 2 of the trial."|First administration of trial medication until 28 days after last drug administration|Treated Set in Stage 1 : This analysis set included the randomized patients who took at least 1 dose of the randomized treatment (61 afatinib and 60 cetuximab patients. Treated set in Stage 2: This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.||number of participants|||Number
135320|NCT00514943|Secondary|Time to Deterioration in HRQoL - Stage 1|"Health related Quality of Life (HRQoL) for Time to deterioration was assessed using the the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the Head and Neck Cancer Module (H&N35).~Time to deterioration in HRQoL (defined as a 10-point change towards worsening from the baseline score on a 0-100 point scale) was determined for:~global health status (Questions 29 and 30 in EORTC QLQ C30)~pain (Questions 9 and 19 in EORTC QLQ C30)~swallowing (Questions 35 to 38 in EORTC QLQ-H&N35)"|From randomisation to deterioration in HRQoL scores before crossover.|Randomised Set (RS)||months||95% Confidence Interval|Median
135321|NCT00514943|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to data cut-off date.|Randomised set (RS).||Weeks||95% Confidence Interval|Median
135322|NCT00514943|Secondary|Progression Free Survival (PFS) After Crossover Based on Investigator Assessment|"PFS is defined as time from first administration study medication after cross over until the occurrence of tumor progression or death, whichever came first, during Stage 2 of the trial.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover.|Patients treated in stage 2||weeks||95% Confidence Interval|Median
135323|NCT00514943|Secondary|Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment|"PFS is defined as time from randomisation to until the occurrence of tumor progression or death, whichever occurred first, during Stage 1 of the trial.~Median is calculated from the Kaplan−Meier curve for each treatment group."|From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover.|Randomised set (RS).||weeks||95% Confidence Interval|Median
135324|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2|Best RECIST Assessment as confirmed duration of disease control as per the independent central review (ICR) assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2||Weeks||Standard Deviation|Mean
135325|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2|Best RECIST Assessment as confirmed duration of objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|patients treated in stage 2||Weeks||Standard Deviation|Mean
135326|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)||Weeks||Standard Deviation|Mean
135327|NCT00514943|Secondary|Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1|Best RECIST Assessment as duration of confirmed objective response and disease control as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised Set (RS)||Weeks||Standard Deviation|Mean
135328|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2||Number of participants|||Number
135329|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
135330|NCT00514943|Secondary|Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1|Best RECIST Assessment as onset of confirmed objective response as per Investigator assessment for Stage 1.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
135331|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2||Number of participants|||Number
135332|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment|Patients treated in Stage 2||Number of participants|||Number
135333|NCT00514943|Secondary|Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Best objective response ( complete response (CR) or partial response (PR)) as assessed by the independent central review (ICR) according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
135334|NCT00514943|Secondary|Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).|Best RECIST Assessment is defined as confirmed Disease control (complete response (CR), partial response (PR) and Stable disease (SD)), Objective response ( complete response (CR) or partial response (PR)) assessed by the investigator according to the RECIST 1.0 criteria.|Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment|Randomised set (RS).||Number of participants|||Number
135335|NCT00514943|Secondary|Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments|Tumor shrinkage after crossover was defined as the change from baseline in the smallest post-crossover sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after crossover minus SLD at baseline. Baseline was the SLD measured at the time of crossover, or the closest measurement before the patient started stage 2 treatment. A negative value means the smallest post-crossover SLD was smaller than baseline (decreased after crossover), a positive value means tumor size increased after crossover.|From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment.|Patients treated in stage 2 : This analysis set included all patients who received treatment: 36 patients in the afatinib and 32 patients in the cetuximab arm.||millimeters||Standard Deviation|Mean
135336|NCT00514943|Primary|Tumor Shrinkage Before Crossover (Stage 1) of the Trial as Per Investigator Assessment|"Tumor shrinkage before crossover was defined as the change from baseline in the smallest post-randomisation sum of the longest diameters of target lesions (SLD), calculated as the smallest SLD after randomisation but before crossover minus SLD at baseline. Baseline was the SLD measured before randomisation. A negative value means the smallest post-randomisation SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.~Mean calculated is actually the Adjusted mean. Adjusted mean is obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions as covariates."|From randomization until start of Stage 2 treatment, or within 28 days after the termination of Stage 1.|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment, whether treated or not. However, patients without baseline or post-baseline tumor measurements were excluded.||millimeter||Standard Error|Mean
135337|NCT00514917|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAE: any adverse event (AE) that occurred or worsened during the on-treatment period, which was the period from first administration of study treatment until 30 days after last administration of study treatment. AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly, or medically important. Drug-related AEs were any untoward medical occurrences attributed to study drug in a participant who received study drug. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 Grade 3 (severe) and Grade 4 (life threatening/disabling) TEAEs were also reported.|From first administration of study treatment until 30 days after the last administration of study treatment|Safety population included all randomized participants who received at least part of one dose of any of the study drugs.||participants|||Number
135338|NCT00514917|Secondary|Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT|EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity.|Baseline, EOT (up to Month 18)|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively."||units on a scale||Standard Deviation|Mean
135350|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein|Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)|Change from baseline at Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
135339|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following completion of treatment of leuprolide with at least 1 follow-up PSA assessment.||percent chance of being progression-free||95% Confidence Interval|Number
135340|NCT00514917|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT|MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue).|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
135341|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population|PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following the completion of treatment of leuprolide with at least 1 follow-up PSA assessment.||months||95% Confidence Interval|Median
135342|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT|Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
135343|NCT00514917|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT)|FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome.|Baseline, EOT (up to Month 18)|ITT population. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
135344|NCT00514917|Secondary|Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)|The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer.|Randomization until death due to prostate cancer, assessed up to Month 60|ITT population.||participants|||Number
135345|NCT00514917|Secondary|Overall Survival (OS): Number of Participants Who Died (All Cause)|The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause.|Randomization until death due to any cause, assessed up to Month 60|ITT population.||participants|||Number
135346|NCT00514917|Primary|Progression-Free Survival (PFS) Rate at Month 36 in ITT Population|PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.|Month 36|ITT population.||percent chance of being progression-free||95% Confidence Interval|Number
135347|NCT00514917|Primary|Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population|PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter [ng/mL]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method.|Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60|ITT population included all participants who were randomized, with study drug assignment designated according to randomization, regardless of whether participants received any study drug or a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
135348|NCT00514852|Secondary|Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score|Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)|Change from baseline at Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
135349|NCT00514852|Secondary|Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein|Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)|Change from baseline at Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
138084|NCT00487240|Secondary|Change From Baseline in Absolute Body Weight at 32 Week Endpoint||Baseline, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.||kilograms||Standard Deviation|Mean
135351|NCT00514852|Post-Hoc|Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30|Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining)|Day 30|Intent to Treat Population||Units on a scale||Standard Deviation|Mean
135352|NCT00514852|Post-Hoc|Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30|Vision subscale of the Ocular Surface Disease Index Questionnaire© is measured on 6 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Day 30|Intent to Treat Population (Modified)||Units on a scale||Standard Deviation|Mean
135353|NCT00514852|Secondary|Patient Acceptability Score (Vision) at Day 30|Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).|Day 30|Intent to treat population||Units on a scale||Standard Deviation|Mean
135354|NCT00514852|Secondary|Patient Acceptability Score (Dryness) at Day 30|Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).|Day 30|Intent to Treat Population||Units on scale||Standard Deviation|Mean
135355|NCT00514852|Secondary|Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein|Measures the stability of tear film. The average of 3 measures.|Change from baseline at Day 30|Intent to Treat Population||seconds||Standard Deviation|Mean
135356|NCT00514852|Secondary|Change From Baseline at Day 30 in Schirmer Test, With Anesthesia|Schirmer Test measures the rate of the secretion of tears|Change from baseline at Day 30|Intent to Treat Population||mm/5min||Standard Deviation|Mean
135357|NCT00514852|Primary|Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score|Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)|Change from baseline at Day 30|Intent to Treat Population (Modified)||Units on a scale||Standard Deviation|Mean
135358|NCT00514813|Secondary|Change From Baseline in Hematocrits at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||||
135359|NCT00514813|Secondary|Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years||Baseline and 2 years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||||
135360|NCT00514813|Primary|Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)||Over the course of 2 Years|This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.|||||
135361|NCT00514735|Secondary|Improved Quality of Life Over 6 Months Compared to Baseline.|The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||Scores on a scale||Standard Deviation|Mean
135362|NCT00514735|Secondary|Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.|The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||AF Symptom Severity Score||Standard Deviation|Mean
135363|NCT00514735|Secondary|Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.|Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||percent||Standard Deviation|Mean
135364|NCT00514735|Secondary|Improvement of Left Atrial Size at 6 Months Compared to Baseline.|Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||centimeters||Standard Deviation|Mean
135365|NCT00514735|Secondary|Acute Efficacy|"A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:~Medtronic ablation catheters were used to achieve procedure success.~All accessible pulmonary veins were isolated.~At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters.~Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion)."|Procedure conclusion|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||percentage of participants||95% Confidence Interval|Mean
135378|NCT00514683|Secondary|Change From Baseline in IC|Change from Baseline in Inspiratory Capacity (IC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
135379|NCT00514683|Secondary|Change From Baseline in VC|Change from baseline in Vital capacity (VC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
135366|NCT00514735|Primary|Chronic Safety|The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||participants|||Number
135367|NCT00514735|Primary|Acute Safety|The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.|7 days|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group.||percentage of participants||95% Confidence Interval|Mean
135368|NCT00514735|Primary|Chronic Effectiveness|"The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:~A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes.~The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only)~The Investigator judged all procedures to be acutely successful (Ablation Management arm only)."|6 months|An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject’s assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.||percentage of participants with success|||Number
135369|NCT00514709|Secondary|Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.~Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.||Participants|||Number
135370|NCT00514709|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in a sub-set of the participants available for the endpoint, the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
135371|NCT00514709|Primary|Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.~Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response."|Day 0 (pre-vaccination) and Day 28 post-booster vaccination|Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.||Participants|||Number
135372|NCT00514683|Secondary|Pre-dose Plasma Concentration of Nintedanib in Plasma at Steady State on Day 365 (Cpre,ss,365) and Day 729 (Cpre,ss,729).|Cpre,ss,729 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 729 and Cpre,ss,365 represents the pre-dose plasma concentration of nintedanib in plasma at steady state on Day 365. At day 365, values only for Nintedanib 50 qd group are presented as no values reported for other groups and at day 729, values are presented for all group except for Nintedanib 50 qd group as no values reported for it.|day 365 and day 729|Randomised set||ng/mL||Geometric Coefficient of Variation|Geometric Mean
135373|NCT00514683|Secondary|Time to Progression|"Time to progression. Progression was defined as at least one of the following: 5mmHg increase in the alveolo-arterial pressure difference in oxygen (P(A-a)O2), 10% decrease in FVC (FVC(baseline)-FVC(progression) >= 10%) or Death.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC - Randomised set||Days||95% Confidence Interval|Median
135374|NCT00514683|Secondary|Survival (Death Due to Respiratory Cause, and Lung-transplant Free)|"Survival (death due to respiratory cause, and lung-transplant free) at 52 weeks.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set||percentage of participants|||Number
135375|NCT00514683|Secondary|Time to First Occurrence of IPF Exacerbation|"This endpoint is called time to first occurrence of IPF exacerbation however it was actually analysed as the proportion of patients having occurrence of Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set||percentage of participants|||Number
135376|NCT00514683|Secondary|Occurrences of IPF Exacerbations Per Patient Per Year|Occurrences of Idiopathic Pulmonary Fibrosis (IPF) exacerbations per patient per year at 52 weeks|52 weeks|OC-Randomised set||Exacerbations Per Year||Standard Deviation|Mean
135377|NCT00514683|Secondary|Number of Patients With at Least One IPF Exacerbation|Number of patients with at least one Idiopathic Pulmonary Fibrosis (IPF) exacerbation at 52 weeks|52 weeks|OC-Randomised set||participants|||Number
148571|NCT00399542|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
135380|NCT00514683|Secondary|Change From Baseline in TGV|Change from Baseline in Thoracic gas volume (TGV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
135381|NCT00514683|Secondary|Change From Baseline in RV|Change from Baseline in Residual volume (RV) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
135382|NCT00514683|Secondary|Change From Baseline in TLC|Change from Baseline in Total Lung Capacity (TLC) at 52 weeks. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
135383|NCT00514683|Secondary|St George's Respiratory Questionnaire (SGRQ) Responder|St George's Respiratory Questionnaire (SGRQ) responder (<= -4 points change) (%) at 52 weeks-worst case|52 weeks|Worst case - Randomised set||percentage of participants|||Number
135384|NCT00514683|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Domain Score Activities|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score activities. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||units on a scale||Standard Error|Mean
135385|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Impacts|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF - Randomised set||units on a scale||Standard Error|Mean
135386|NCT00514683|Secondary|Change From Baseline in SGRQ Domain Score Symptoms|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) domain score symptoms. Scores range from 0 to 100, with higher scores indicating more limitations.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||units on a scale||Standard Error|Mean
135387|NCT00514683|Secondary|Change From Baseline in SGRQ Total Score|"Change from baseline in Saint George's Respiratory Questionnaire (SGRQ) total score. Total score is defined as sum of the three domain scores symptoms, activities and impacts. Scores range from 0 to 100, with higher scores indicating worst possible health status.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||units on a scale||Standard Error|Mean
135388|NCT00514683|Secondary|Absolute Change From Baseline in FEV1/FVC|"Change from baseline of percentage of FVC expelled in the first second of a forced expiration (FEV1/FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||percentage of FVC||Standard Error|Mean
135389|NCT00514683|Secondary|Absolute Change From Baseline in MRC Dyspnea Scale by Categories|"Absolute change from baseline in Medical Research Council (MRC) dyspnea scale by below mentioned categories:~Decrease~No Change~Increase"|Baseline and 52 weeks|LOCF- Randomised||percentage of participants|||Number
135390|NCT00514683|Secondary|Change From Baseline in Dyspnoea Rating on Borg Scale After Exercise (6-MWT)|"Change from baseline in Dyspnoea rating after exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||Units on a scale||Standard Error|Mean
135391|NCT00514683|Secondary|Absolute Change From Baseline in Dyspnoea Rating on Borg Scale Before Exercise (6-MWT)|"Absolute change from baseline in Dyspnoea rating before exercise (6-MWT) at 52 weeks based on Borg scale as mentioned below :~0: Nothing at all, 0.5: Very, very slight (just noticable), 1: Very slight, 2: Slight (light), 3: Moderate, 4: Somewhat severe, 5: Severe (heavy), 6, 7:Very severe, 8, 9, 10: Very, very severe (Maximal).~The 6-Minutes Walk Test (6-MWT) was conducted according to the ATS Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||Units on a scale||Standard Error|Mean
135392|NCT00514683|Secondary|Absolute Change From Baseline in Distance Walk (6-MWT)|Absolute change from baseline in distance walk (6-MWT) at 52 weeks. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|LOCF-Randomised set||Meter||Standard Error|Mean
135393|NCT00514683|Secondary|Absolute Change From Baseline in DLCO by Categories|"Absolute change from baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) by below mentioned categories:~Decrease > 15% or > 1~Change <= 15% or <= 1~Increase > 15% or > 1"|Baseline and 52 weeks|LOCF Randomized set||percentage of patients|||Number
135394|NCT00514683|Secondary|Absolute Change From Baseline in DLCO|"Absolute change from Baseline in Diffusing capacity of the lung for carbon monoxide (DLCO) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||mmol.min^−1.kPa^−1||Standard Error|Mean
135395|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a) O2 by Categories|"Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a) O2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set||percentage of participants|||Number
135396|NCT00514683|Secondary|Absolute Change From Baseline in PaO2 by Categories|"Absolute change from baseline in Arterial oxygen partial pressure (PaO2) by below mentioned categories:~Decrease > 4 mmHg~Change within +/- 4 mmHg~Increase > 4 mmHg"|Baseline and 52 weeks|OC - Randomised set||percentage of participants|||Number
135397|NCT00514683|Secondary|Absolute Change From Baseline in PaCO2|Absolute change from baseline in Arterial carbon dioxyde partial pressure (PaCO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set||mmHg||Standard Error|Mean
135398|NCT00514683|Secondary|Absolute Change From Baseline in P(A-a)O2|Absolute change from baseline in Alveolo-arterial oxygen gradient (P(A-a)O2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set||mmHg||Standard Error|Mean
135399|NCT00514683|Secondary|Absolute Change From Baseline in PaO2|Absolute change from baseline in Arterial oxygen partial pressure (PaO2) at week 52. Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region.|Baseline and 52 weeks|OC-Randomised set||mmHg||Standard Error|Mean
135400|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest by Categories|"Absolute change from baseline in oxygen saturation (SpO2) at rest by below mentioned categories:~SpO2 (non-invasive) at 52 weeks:~Decrease > 4% SpO2~Change within +/- 4% SpO2~Increase > 4% SpO2"|Baseline and 52 weeks|LOCF-Randomised set||percentage of participants|||Number
135401|NCT00514683|Secondary|Absolute Change From Baseline in SpO2 at Rest|"Absolute change from baseline in oxygen saturation (SpO2) at rest.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline, region."|Baseline and 52 weeks|LOCF-Randomised set||Percentage of SpO2||Standard Error|Mean
135402|NCT00514683|Secondary|Survival (All Causes of Death and Lung-transplant Free)|"Survival (all causes of death and lung-transplant free) at 52 weeks, based on overall mortality and on-treatment survival.~Failure means participants with event and Censored means participants with no event."|52 weeks|OC-Randomised set||participants|||Number
135403|NCT00514683|Secondary|Number of Participants With Change From Baseline in FVC by Categories|"Change from baseline in percentage of Forced Vital Capacity (FVC) at 52 weeks in below mentioned categories:~Decrease > 10% or 200mL~Change within <= 10% or <=200 mL~Increase > 10% or 200mL"|Baseline and 52 weeks|LOCF-Randomised set||participants|||Number
135404|NCT00514683|Secondary|Relative Change From Baseline in FVC|"Percent change from baseline in absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region"|Baseline and 52 weeks|LOCF-Randomised set||percentage change||Standard Error|Mean
135405|NCT00514683|Secondary|Relative Change From Baseline in FVC%Pred|"Percent change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set||percentage of change||Standard Error|Mean
135406|NCT00514683|Secondary|Absolute Change From Baseline in FVC|"Change from baseline in percentage of absolute Forced Vital Capacity (FVC) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|LOCF-Randomised set||Liters||Standard Error|Mean
135407|NCT00514683|Secondary|Absolute Change From Baseline in FVC%Pred|"Change from baseline in percentage of predicted Forced Vital Capacity (FVC%pred) at 52 weeks.~Means were adjusted based on an ANCOVA with fixed terms for treatment, baseline and region."|Baseline and 52 weeks|"Last Observation Carried Forward (LOCF): This method was used for the replacement of missing values.~Randomised set: This patient set includes all randomised patients whether treated or not."||percentage of predicted FVC||Standard Error|Mean
135408|NCT00514683|Primary|Rate of Decline in FVC|"Rate of decline in Forced Vital Capacity (FVC) evaluated from baseline until 52 weeks of treatment.~The means presents actually the adjusted rate based on a MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time."|Baseline until 52 weeks|"Observed Case (OC): This method was used for the replacement of missing values.~Randomised set: This patient set includes all randomised patients whether treated or not."||Liters/year||Standard Error|Mean
135409|NCT00514592|Secondary|Any Stroke Before Carotid Enderarterectomy|Same as primary endpoint, but includes stroke of all types.|Before CEA|||participants|||Number
135410|NCT00514592|Primary|Ipsilateral Ischemic Stroke Before Carotid Endarterectomy|Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.|Before CEA|||participants|||Number
135411|NCT00514514|Secondary|Efficacy Event Data After Month 12 to Month 60|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|Events starting after Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Participants|||Number
135412|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 60|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed were previously enrolled in the core study and had at least one serum creatinine value in the extension period.||mg/dl||95% Confidence Interval|Least Squares Mean
135413|NCT00514514|Secondary|GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the –MDRD formulat:~For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
135414|NCT00514514|Secondary|GFR at Month 60 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 60 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
138438|NCT00484159|Primary|Cost Per Successful Procedure|Total cost per effective treatment at 3-months. Successful procedure defined as greater or equal to 50% pain relief and satisfaction lasting at least 3 months.|3-months|||U.S. dollars|||Number
135415|NCT00514514|Secondary|GFR Calculated Via Nankivell Formula at Month 60|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 60|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
135416|NCT00514514|Secondary|Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)|The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years.|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Percent risk||Standard Deviation|Mean
135417|NCT00514514|Secondary|Efficacy Event Data Baseline 2 (Month 3) to Month 12|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 12|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Participants|||Number
135418|NCT00514514|Secondary|Efficacy Event Data From Baseline 2 (Month 3) to Month 6|Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).|From Baseline 2 (Month 3) to Month 6|The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.||Participants|||Number
135419|NCT00514514|Secondary|Mean Change in Serum Creatinine From Month 3 to Month 12|Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed required at least one post randomization value. ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization||mg/dl||95% Confidence Interval|Least Squares Mean
135420|NCT00514514|Secondary|GFR at Month 12 Utilizing Cockcroft-Gault Formula|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
135421|NCT00514514|Secondary|GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method|"Change in GFR (Modification of Diet in Renal Disease calculated using the –MDRD formulat:~For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate."|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
135422|NCT00514514|Secondary|GFR Via Nankivell Formula at Month 12 - All Regimens|Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
135452|NCT00513604|Primary|Clinical Response|Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012|||Participants|||Number
135423|NCT00514514|Primary|GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen|Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted|From randomization at BL2 (Month 3) to Month 12 post-transplant|Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.||ml/min/1.73m²||95% Confidence Interval|Least Squares Mean
135424|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.||% (n/N)||95% Confidence Interval|Number
135425|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.||% (n/N)||95% Confidence Interval|Number
135426|NCT00514501|Primary|Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)|"Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).~Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.~Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers."|Day 30|The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.||% (n/N)||95% Confidence Interval|Number
135427|NCT00514215|Secondary|Immune Function and Cancer-specific Response|CT-guided biopsy & Peritumoral GM-CSF|Days 1 & 32||||||
135428|NCT00514215|Secondary|Toxicity|CBC, sodium, potassium, BUN, serum creatinine, calcium, glucose, SGOT, Alk Phos, bilirubin, Electrolytes, Albumin (Alb), Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Total bilirubin (TBIL), Direct bilirubin (Conjugated Bilirubin), Gamma glutamyl transpeptidase (GGT)|Days 11, 32, 43, & 63||||||
135429|NCT00514215|Secondary|Clinical Response as Measured by CT Criteria|CT-guided biopsy|Days 1 & 32||||||
135430|NCT00514215|Primary|Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry|CT-guided biopsy & Peritumoral GM-CSF|Days 1 & 32|Patients who had metastatic Renal Cell carcinoma||percentage of participants||90% Confidence Interval|Number
135431|NCT00514137|Secondary|Toxicity|Assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Included are the toxicities at least possibly related to the study drug.|From the time of first treatment to up to 30 days after the last day of study drug treatment|||participants|||Number
135432|NCT00514137|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|From the documentation of response until the date of progression|No analysis was done because there were no confirmed responses.|||||
135433|NCT00514137|Secondary|Event-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
135434|NCT00514137|Primary|The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])|"A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart.~A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis.~A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas.~A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma."|Every 6 weeks from the first initiation of therapy up to 72 weeks|All 13 participants were evaluable for a response||participants|||Number
135435|NCT00514020|Primary|"Number of Patients With Each Response in Good Risk Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])"|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.|every 8 weeks to progression|"Patients available for measurement of response. All patients who received Oxaliplatin + Leucovorin + 5-Fluorouracil are in the heterozygous good risk genotype group. One patient was not evaluable for response."||participants|||Number
135436|NCT00513799|Secondary|Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|4 month follow-up|||Participants|||Number
135437|NCT00513799|Secondary|Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection|Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.|1, 4 and 6 month follow-ups|Groups 1/4 have 1 more participant analyzed each than in participant flow module due to data collected by phone. They did not return to hospital for followup (colonization swabs were not obtained). Group 3 has 1 less participant analyzed than in participant flow module due to missing data point on followup survey. They were not able to be reached.||Participants|||Number
135438|NCT00513799|Primary|Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.|1 month follow-up|||Participants|||Number
135439|NCT00513708|Secondary|Completed Inpatient Treatment|"Completion of inpatient treatment was defined as being admitted to and successfully discharged from an inpatient alcohol treatment program (e.g., a 28-day program). Participants who left the inpatient program against medical advice or who received an administrative discharge were not considered to have successfully completed the inpatient program."|90 days|"There were 50 participants in each arm; the number of participants analyzed represents the number of those 50 in each arm who were admitted to an inpatient treatment program (e.g., a 28-day program)."||Participants|||Number
135440|NCT00513708|Secondary|Relapse to Drinking|"Relapse to drinking was defined as the consumption of one or more standard drinks (approximately 12 grams of ethanol)during the first 30 days following discharge from the inpatient detoxification unit. The date of discharge was considered to be Day 1."|30 days|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, relapse or no relapse) available at the 30-day follow-up."||participants|||Number
135441|NCT00513708|Primary|"Linkage to Alcohol Behavioral Therapy Counseling (i.e., Aftercare)"|"Linkage to alcohol behavioral therapy counseling (i.e., aftercare) was defined as: arriving for the first outpatient chemical dependency counseling visit, being admitted to an inpatient or residential chemical dependency treatment facility, or attending at least one meeting of a help-help program such as Alcoholics Anonymous."|1 month|"There were 50 participants in each arm. Per protocol, the number of participants analyzed represents the number that had outcome data (i.e, linked to aftercare or not linked to aftercare) available at the 30-day follow-up."||participants|||Number
135442|NCT00513682|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72- hour period in either washout phase or treatment phase. Nitrogen intake was calculated as protein intake/6.25. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.||Percent CNA||Standard Deviation|Mean
135443|NCT00513682|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period in either washout phase or treatment phase. Mean percent CFA was calculated for Day 3 to Day 5 or Day 6 of the respective phase.|Day 3 to Day 5 or Day 6 during washout phase and treatment phase|Intent-to-treat (ITT) population included all the participants who took at least 1 dose of Ultrase® MT20 and had completed at least 1 phase (washout or treatment phase) evaluating primary and secondary efficacy parameters.||Percent CFA||Standard Deviation|Mean
135444|NCT00513617|Secondary|Fetal Hemoglobin|Fetal hemoglobin (HbF) as measured by the Advia machine|12 weeks after randomization||||||
135445|NCT00513617|Secondary|Endothelin-1|Endothelin-1 is a potent vasoconstrictor and pro-inflammatory agent which is elevated in SCD patients|12 weeks after randomization||||||
135446|NCT00513617|Secondary|8-iso-PGF2a|8-iso-PGF2a is a measure of lipid peroxidation and oxidative damage in vivo measured by enzyme immunoassay kit from Cayman chemical|12 weeks after randomization||||||
135447|NCT00513617|Primary|Mean Corpuscular Hemoglobin Concentration|Mean corpuscular hemoglobin concentration as measured by an Advia machine|12 weeks after randomization|||g/dL||Standard Deviation|Mean
135448|NCT00513617|Primary|Nitric Oxide|Nitric oxide from plasma amino acids|12 weeks after randomization|All subjects that were randomized and dosed - ITT No imputation used.||uM||Standard Deviation|Mean
135449|NCT00513617|Secondary|Soluble Vascular Cell Adhesion Molecule|Soluble vascular cell adhesion molecule (sVCAM) a vascular adhesion molecule|12 weeks after randomization||||||
135450|NCT00513617|Primary|Gardos Channel Activity|Gardos channel activity: a calcium (Ca2+)–activated K+ channel|12 weeks after randomization|All subjects that were randomized and dosed - Intent to Treat (ITT) No imputation used.||mmol/10^13 cells x min||Standard Deviation|Mean
135451|NCT00513604|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|5 years|||Participants|||Number
135453|NCT00513526|Secondary|Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series||Weeks 0, 28 and 76|Samples for this outcome measure were not analyzed due to loss of funding for the central lab.|||||
135454|NCT00513526|Secondary|HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
135455|NCT00513526|Secondary|HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
135456|NCT00513526|Secondary|HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
135457|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
135458|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
135459|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
135460|NCT00513526|Secondary|HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status||weeks 0, 28, and 76|Intent to treat population, includes all participants who received at least one dose of vaccine||Milli-Merck units/mL||95% Confidence Interval|Geometric Mean
135461|NCT00513526|Secondary|Longitudinal Changes in Plasma HIV-1 RNA From Baseline|Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.||copies/ml||Inter-Quartile Range|Median
135462|NCT00513526|Secondary|Longitudinal Changes in CD4+ Cell Count From Baseline|CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.|Week 0, 4, 12, 28|Intention to treat population, includes all participants who received at least one dose of vaccine and had assessments at week 0 and the specified week.||cells/uL||Inter-Quartile Range|Median
135463|NCT00513526|Primary|Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline||Week 28|Per protocol population for a given HPV type requires patients to be seronegative for that type at entry and to have no HPV DNA detected by PCR for that type at entry and screening. Also, patients must have received 3 doses of vaccine.||proportion of participants||95% Confidence Interval|Number
135464|NCT00513526|Primary|Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine||All study visits|Intention to treat (i.e., received at least one dose of the vaccine)||participants|||Number
135465|NCT00513500|Secondary|Number of Children Who do Not Respond to Treatment for Pneumonia||one year|Based on number classified as having pneumonia. Analysis was per intention to treat||participants|||Number
135466|NCT00513500|Primary|Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)||one year|The participants analyzed was based on children reported with fever. Analysis was per intention to treat.||participants|||Number
135467|NCT00513500|Primary|Number of Children Who Received Early and Appropriate Treatment for Pneumonia.|Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom|one year|The number of participants determined for this analysis was based on those classified as pneumonia. The analysis was based on an intent-to-treat basis.||partcipants|||Number
135468|NCT00513435|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival.|Up to 12 weeks|||Days||Full Range|Median
135469|NCT00513435|Primary|Overall Response Rate|Response was determined as inicated in the protocol.|From the start of treatment for up to 12 weeks|||participants|||Number
135470|NCT00513409|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value|Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results.||subjects|||Number
135471|NCT00513409|Secondary|Anti-hepatitis A Virus Antibodies Concentration|Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results||mIU/mL||95% Confidence Interval|Geometric Mean
135472|NCT00513409|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results||subjects|||Number
135473|NCT00513409|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results||subjects|||Number
135474|NCT00513409|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F."|Before (pre) and one month after (post) the administration of Dose 2|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results||subjects|||Number
135475|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)|||subjects|||Number
135476|NCT00513409|Secondary|Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)|||subjects|||Number
135477|NCT00513409|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after the administration of any study vaccine dose|||subjects|||Number
135478|NCT00513409|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.~Fever was defined as rectal temperature ≥ 38 degrees Celsius."|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.||subjects|||Number
135479|NCT00513409|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.||subjects|||Number
135480|NCT00513409|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)|Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).|Within 4 days after the administration of any study vaccine dose|Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.||subjects|||Number
135481|NCT00513370|Secondary|Change in Resource Utilization Outcomes and Costs From Baseline as Measured by the Health Care Resource (HCR) Questionnaire||16 and 24 weeks||||||
135482|NCT00513370|Secondary|Change in Productivity Outcomes and Costs From Baseline as Measured by the Health and Labour Questionnaire (HLQ)||16 and 24 weeks||||||
135483|NCT00513370|Secondary|Change From Baseline on the EuroQol (EQ-5D) Quality of Life Questionnaire||16 and 24 weeks||||||
135484|NCT00513370|Secondary|Mean Change From Baseline in Beck Depression Inventory (BDI-II) at 16 and 24 Weeks|Change in the Beck Depression Inventory from Baseline. The BDI-II contains 21 questions and is scored from 0-63; higher scores indicate more severe depression symptoms.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
135485|NCT00513370|Secondary|Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0|Number of subjects achieving a Dermatology Life Quality Index (DLQI) score of 0 (indicating total lack of impairment). The DLQI consists of 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
135486|NCT00513370|Secondary|Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at 16 and 24 Weeks|Mean change in the Dermatology Life Quality Index (DLQI) from Baseline. The questionnaire contains 10 questions and is scored from 0-30, where 0 = total lack of impairment and 30 = my life is very much impaired; the minimum clinically important difference is 2.3 to 5.7 point change.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
135487|NCT00513370|Secondary|Mean Change From Baseline in Patient's Global Assessment of Joint Pain at 16 and 24 Weeks|Mean change in the Patient's Global Assessment of Joint Pain from Baseline, as assessed on a 100-mm visual analog scale where 0 mm = no pain and 100 mm = pain as bad as it could be.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
135488|NCT00513370|Secondary|Mean Change From Baseline in Swollen Joint Count at 16 and 24 Weeks|Mean change in the number of swollen joints from Baseline. 76 joints were evaluated for swelling, corresponding to all joints evaluated for tenderness except for the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||number of joints||Standard Deviation|Mean
135489|NCT00513370|Secondary|Mean Change From Baseline in Tender Joint Count at 16 and 24 Weeks|Mean change in the number of tender joints from Baseline. 78 joints were evaluated for tenderness, including all 76 joints evaluated for swelling plus the hip joints.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||number of joints||Standard Deviation|Mean
135490|NCT00513370|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response|PASI 50/75/90/100 is a >=50% / >=75% / >=90% / 100% improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
135491|NCT00513370|Secondary|Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity at 16 and 24 Weeks|Mean Change from Baseline in Physician Global Assessment of Arthritic Disease Activity as measured on a 100-mm visual analog scale where 0 mm = no arthritis activity and 100 mm = extremely active arthritis.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||units on a scale||Standard Deviation|Mean
135492|NCT00513370|Secondary|"Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of Clear or “Clear or Minimal”"|"Number of subjects achieving a response of Clear or Clear or Minimal on the Physician's Global Assessment for Psoriasis. This is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Minimal, 2-Mild, 3-Moderate, 4-severe, 5-very severe."|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
135493|NCT00513370|Secondary|Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)|Number of subjects with improvement on the Physician's Global Assessment for Psoriasis (PGA). The PGA is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject, where 0 = clear and 6 = very severe. Improvement is defined as a reduction in PGA score.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
135494|NCT00513370|Secondary|Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean percent change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree.|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||percent change||Standard Deviation|Mean
135495|NCT00513370|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks|Mean change in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score ranges from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 and 24 weeks|Observed Cases - subjects with nonmissing values at each time point||unit on a scale||Standard Deviation|Mean
135496|NCT00513370|Primary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks|PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree|16 weeks|Observed Cases - subjects with nonmissing values at each time point||participants|||Number
135497|NCT00513357|Primary|Change in Appetite as Measured by ESAS|Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation [± 3 days] to 4 week evaluation [± 3 days], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.|Baseline and at 4 weeks|||units on a scale||Standard Deviation|Mean
135498|NCT00513344|Secondary|Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake|"Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff.~An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia."|baseline and 2 hours|||percentage of baseline||Standard Deviation|Mean
135499|NCT00513344|Primary|Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake|Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser.|Baseline and 2 hours|"Taking into account the fact that there is no background data and that we need to have accurate evaluation of central tendency and dispersion, a minimum of five complete subjects are needed.~Data from all randomized subjects were considered in the intention to treat model (for the primary outcome)."||percentage of the pulse wave amplitude||Standard Error|Mean
135500|NCT00513305|Secondary|Proportion of Participants Surviving at 6 Months and 12 Months Using the Kaplan Meier Estimate|The duration of overall survival was defined for all patients and was measured from the date of randomization until death from any cause. For a patient who was not known to have died by the end of the follow-up period, observation of overall survival was censored on the date the patient was last known to be alive. The estimate of likelihood of survival at 6 and 12 months after Baseline using the Kaplan Meier Estimate is presented here.|Baseline through 12 months|||Proportion of Participants||95% Confidence Interval|Number
135501|NCT00513305|Secondary|Number of Participants Who Experienced Induction (Thirty-Day) Mortality|The number of subjects who died from any cause within the first 30 days after the start of study drug treatment is presented here.|Up to 30 days following start of study drug treatment|||Participants|||Number
135502|NCT00513305|Secondary|Number of Participants Who Experienced Early Death|Early death is defined as death from any cause within the first 14 days after start of study drug treatment. The number of patients in each study group who experienced early death is presented here.|14 days from start of study drug treatment|||Participants|||Number
135503|NCT00513305|Secondary|Proportion of Participants With Relapse-Free Survival (RFS)Using the Kaplan-Meier Estimate|RFS is defined for patients who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR), and was measured from the date of attaining CR, CRp, or PR until the date of AML relapse or death from any cause, whichever occurred first. For a patient not known to have relapsed or died by the end of the study followup, observation of relapse free survival was censored on the date of the last followup examination. The Kaplan Meier Estimate of relapse-free survival at Month 3 and Month 6 is presented here.|From Baseline (randomization) through 24 months following Baseline|Population analyzed are the subjects who who achieved a complete remission (CR), complete remission with incomplete platelet recovery (CRp), or partial remission(PR)during the course of the study||Proportion of participants||95% Confidence Interval|Number
135504|NCT00513305|Secondary|Number of Participants Who Died or Were Censored by 24 Months|This measure (time to death or censor) was defined for all enrolled subjects from the date of randomization until death from any cause. If a subject was not known to have died by the end of the followup period, observation of overall survival was censored on the date the patient was last known to be alive. The number of participants who died or were censored is presented here. (Note: all subjects participating in this study had either died or were censored by 24 months.)|From Baseline through 24 months following Baseline|||Participants|||Number
135505|NCT00513305|Primary|Percentage of Participants in Complete Remission (CR)|The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.|From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator|Intention to treat (ITT) Analysis Set||Percentage of participants in CR|||Number
135506|NCT00513292|Secondary|Overall Survival (OS)|OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. The difference will be tested using the log-rank test, stratified by tumor size (2.0 - 4.0 cm, > 4.0 cm), age (< 50, >= 50), and hormone receptor status (ER- and PgR-negative, ER- and/or PgR-positive).|From time to registration to death, assessed up to 5 years||06/2017||||
135507|NCT00513292|Secondary|Disease-free Survival (DFS)|DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method. The difference will be tested using the log-rank test, stratified by tumor size (2.0 - 4.0 cm, > 4.0 cm), age (< 50, >= 50), and hormone receptor status (ER- and PgR-negative, ER- and/or PgR-positive).|From time to registration to time of event, assessed up to 5 years||06/2017||||
135508|NCT00513292|Secondary|Breast Conservation Rates|Method of definitive surgery, categorized as breast conserving surgery (“lumpectomy”) or total mastectomy. Breast conservation rates will be compared using the Mantel-Haenszel test, stratified by tumor size (2.0 -4.0 cm, > 4.0 cm), age (< 50, >= 50) and hormone receptor status (ER- and PgR-negative, ER- and/or PgR positive). The Chi-squared will be conducted at the two-sided .05 level. A 95% confidence interval will be computed for the difference in breast conservation rates.|From time surgery to up to 5 years||06/2017||||
135509|NCT00513292|Secondary|Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week|Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)].|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.||percent||Inter-Quartile Range|Median
135510|NCT00513292|Secondary|LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)].|At 12 week|||percent||Inter-Quartile Range|Median
135511|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in LVEF at Week 24|The summary of asymptomatic changed in LVEF.|Baseline, at 24 week|All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.||Percentage of Participants|||Number
135512|NCT00513292|Secondary|Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12|The summary of asymptomatic decrease in LVEF.|Baseline, at 12 week|All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.||Percentage of participants|||Number
135513|NCT00513292|Secondary|Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy|pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).|Up to 5 years|All patients who had clinical N1-3 disease prior to the start of treatment are included in the analysis of the pCR rate in the breast and axillary lymph nodes.||Percentage (95% confidence Interval)||95% Confidence Interval|Number
135514|NCT00513292|Primary|pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy|Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.|Up to 5 years|All patients who started study treatment are included in the analysis of the primary endpoint.||percentage of participants||95% Confidence Interval|Number
135515|NCT00513240|Secondary|Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose.||24 hours after first EPO dose.||||||
135516|NCT00513240|Secondary|EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).||72 hours postoperatively.||||||
135517|NCT00513240|Primary|Scores on Bayley Scales of Infant Development III at Age 1 Years.|3 domains of the Bayley Scales of Infant Development III: Cognitive, Language and Motor Minimum score = 45, maximum score = 155; Population mean = 100, SD = 15; Higher scores are indicative of better outcomes Language scores are reflective of receptive communication and expressive communication subscales. Motor scores are reflective of fine motor and gross motor subscales.|1 year postoperatively|||units on a scale||Standard Deviation|Mean
135518|NCT00513240|Primary|MRI Severity of Injury Score|MRI severity of injury score change from preoperative brain MRI to 7 day postoperative MRI(decrease by 25%). Scoring of infarction, hemorrhage, white matter injury, cerebral venous sinus thrombosis, or increased lactate on MR spectroscopy.|7 days postoperatively.||||||
135519|NCT00513071|Secondary|N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers||At baseline, at 6 hours, at each course (day 1), and at 2 years||||||
135520|NCT00513071|Secondary|Relationship Between Changes in Laboratory Correlates and Response and Survival||Up to 2 years||||||
135521|NCT00513071|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to 2 years||||||
135522|NCT00513071|Secondary|Overall Survival||Up to 2 years||||||
135523|NCT00513071|Secondary|Time to Treatment Failure||Up to 2 years||||||
135525|NCT00513071|Primary|PSA Response Rate|Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR|PSA measured every 4 weeks|||percentage of participants|||Number
135526|NCT00513019|Primary|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) Will be the Primary Outcome Measure|The Yale-Brown Obsessive Compulsive Scale Modified for Neurotic Excoriation (NE-YBOCS) was the primary outcome measure - severity of illness. The NE-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|beginning and at each visit until the end of their participation in the study (12-weeks); investigator rated. Note: Reported mean and standard deviation is the final reported data point.|||units on a scale||Standard Deviation|Mean
135527|NCT00512902|Secondary|Change in Modified Rodnan Skin Score (MRSS)|No measures of dispersion was available as data were lost. The range of this measure is 0 to 51 and measures the extent of skin thickening with higher numbers representing thickening.|Baseline vs. Endpoint|||units on a scale||Standard Deviation|Mean
135528|NCT00512902|Secondary|Change in DLco|DLCO (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) is the extent to which oxygen passes from the air sacs of the lungs into the blood. Commonly, it refers to the test used to determine this parameter.|Baseline vs. Endpoint (1 year)|||Percent predicted||Standard Deviation|Mean
135529|NCT00512902|Secondary|Change in TLC (Total Lung Capacity)|No measures of dispersion was available for TLC as data were lost. This describes the total lung capacity as a percent of predicted.|Baseline vs. Endpoint (1 year)|||Percent predicted||Standard Deviation|Mean
135530|NCT00512902|Secondary|Change in FVC (Forced Vital Capacity)|Measures the amount of air breathed out as a percent of predicted.|Baseline vs. Endpoint (1 year)|||Percent predicted||Standard Deviation|Mean
135531|NCT00512902|Primary|Treatment-related Adverse Events|Treatment-related adverse events requiring discontinuation.|Baseline vs. Endpoint (1 year)|||participants|||Number
135532|NCT00512876|Secondary|Size and Extent of Corneal Neovascularization|computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.|24 weeks|||percentage change||Standard Deviation|Mean
135533|NCT00512876|Primary|Adverse Events (Ocular and Systemic)||24 weeks|||participants|||Number
135534|NCT00512798|Primary|Number of Patients With Clinical Anti-tumor Activity Phase II)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Patients with CR + PR + SD|every 9 weeks to a maximum of 54 weeks|Patients who were available to measure response to the study drugs.||participants|||Number
135535|NCT00512798|Secondary|Patients With Inhibition of NF-kB (Phase II)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Patients with advanced, incurable melanoma who are chemotherapy-naive and patients who had undergone prior chemotherapy with either Dacarbazine or Temozolomide with treatment failure. No degree of inhibition of NF-kB was observed. Phase II not completed due to lack of efficacy.||participants|||Number
135536|NCT00512798|Secondary|Patients With Clinical Anti-tumor Activity (Phase I)|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 9 weeks up to a maximum of 54 weeks|Patients who received treatment and who were available for measurement of lesions.||participants|||Number
135537|NCT00512798|Secondary|Patients With Inhibition in NF-kB Activation (Phase I)|Patient with a minimum of 50% reduction from baseline on day 8 or day 29 in NF-kB, measured by picograms/milliliter in peripheral mononuclear blood cells|at baseline, on day 8 and on day 29|Phase I patients for whom blood was taken at baseline,on day 8 and on day 29 of each cycle. There was no correlation of change in NF-kB activation with changes in tumor tissue||participants|||Number
135538|NCT00512798|Primary|Optimal Doses of Temozolomide and Bortezomib (Phase I)|The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide|up to 42 days|All Phase I patients who received the study drugs||mg/m2|||Number
135539|NCT00512252|Secondary|Relapse-free Survival|"This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause.~Kaplain-Meier estimate was used."|1 year|This excludes the 25 participants who had treatment failure.||percentage of participants|||Number
135540|NCT00512252|Secondary|Overall Survival||1 year|||percentage of participants|||Number
135541|NCT00512252|Secondary|Treatment Failure|Treatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi.|42 days|||participants|||Number
135542|NCT00512252|Secondary|Time to Progression||Every 6 months|"This outcome was not analyzed instead reason for treatment failure was analyzed as it provided better information on why the treatment did not work."|||||
135543|NCT00512252|Secondary|Pharmacokinetics of AMD3100 on MEC||Day 1 - Phase 2 only|This was not performed.|||||
135544|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I)|Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.|Day 0|||percentage of AML blasts||Full Range|Median
135561|NCT00511901|Secondary|POMS Depression-Dejection Scale|Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).|3,8,12 weeks|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a Scale||Inter-Quartile Range|Median
135545|NCT00512252|Secondary|Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I)|"Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0.~Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC."|Day 0|||cells x 10^3/microliter||Full Range|Median
135546|NCT00512252|Secondary|Time to Platelet Recovery|Defined as the date of the first dose of AMD3100 to the date that the platelet count is >100,000/mm3 in the absence of platelet transfusions.|42 days|This analysis includes patients who achieved a CR.||days||Full Range|Median
135547|NCT00512252|Secondary|Time to Neutrophil Recovery|Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count >1,000 cells/mm^3.|42 days|This analysis includes patients who achieved a CR or a CRi.||days||Full Range|Median
135548|NCT00512252|Secondary|Safety and Tolerability of AMD3100 + MEC.|Treatment related mortality (deaths occurring during treatment)|42 days|The 46 patients include the 6 patients treated on Dose Level 3 of the Phase I portion of the study.||participants|||Number
135549|NCT00512252|Primary|Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions||42 days|This outcome was not analyzed as data was not collected.|||||
135550|NCT00512252|Primary|Phase II Only: Complete Response Rate of AMD3100 + MEC|"Responses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response.~Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi)."|42 days|||percentage of participants|||Number
135551|NCT00512252|Primary|Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML|A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 <= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity.|Completion of all patients in Phase I portion (232 days)|The Phase I Dose Escalation portion included (3) patients enrolled in Dose Level 1 and (3) patients enrolled in Dose Level 2. The (6) patients enrolled in Dose Level 3 that determined the Phase II dose are included in the population for this outcome.||mcg/kg|||Number
135552|NCT00512148|Primary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|Clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to adverse event section for detailed information.|through month 12|This analysis was performed on the safety population. Patients undergoing screening and meeting inclusion/exclusion criteria were included in the safety population||participants|||Number
135553|NCT00512148|Primary|Change in Maximum Detrusor Pressure From Baseline to 12 Months|Detrusor pressure is measured using urodynamic testing, which involves inserting a catheter through the urethra and into the bladder and measuring the pressure in the bladder as it is filled with fluid. The primary outcome measure for this study was the change in the maximum pressure observed during bladder filling from baseline to 12 months. The goal of the therapy was to decrease pressure.|baseline and 12 months|All patients with urodynamics measurement performed at baseline and month 12 were included in the analysis.||centimeters of water (cm H2O)||95% Confidence Interval|Mean
135554|NCT00512148|Secondary|Urodynamic Measurements and Long Term Safety||month 12 through month 60||||||
135555|NCT00512096|Primary|Number of Participants With Pathologic Complete Remission (pCR)|Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.|restaging with second and fourth 21-day cycles followed by surgery|Participants who completed chemotherapy without progression then had surgical resection.||participants|||Number
135556|NCT00511914|Primary|Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"Proportion of subjects with either seroconversion (antibody increase from < 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination).~According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be >40% for adults and >30% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages of Subjects||95% Confidence Interval|Number
135557|NCT00511914|Primary|Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).|"HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.~This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70% for adults and >60% for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages of Subjects||95% Confidence Interval|Number
135558|NCT00511914|Primary|Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Ratio||95% Confidence Interval|Geometric Mean
135559|NCT00511914|Secondary|Number of Subjects Reporting Local and Systemic Reactions|To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.|3 days postvaccination|Analysis was done on safety set.||Subjects|||Number
135560|NCT00511914|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).|Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
135593|NCT00511797|Secondary|Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||scores on a scale||Standard Deviation|Mean
135562|NCT00511901|Secondary|Activity Counts|Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Counts||Standard Deviation|Mean
135563|NCT00511901|Secondary|FACIT Measurement System Fatigue Scale|Fatigue score ranges from 0 to 72. Lower score represents less fatigue|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a Scale||Standard Deviation|Mean
135564|NCT00511901|Secondary|Short Physical Performance Battery (SPPB) Score|Measure physical function scored 0 - 12 (better)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a scale||Standard Deviation|Mean
135565|NCT00511901|Secondary|Grip Strength|kilograms measured by hand held dynamometer|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||kg||Standard Deviation|Mean
135566|NCT00511901|Secondary|Length of Stay in Subacute Rehabilitation Facility|Days from randomization to discharge|12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Days||Standard Deviation|Mean
135567|NCT00511901|Secondary|Motor-FIM Score|FIM Motor score ranges from 13 to 91 (most independent)|3, 8, and 12 weeks following randomization|exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up||Scores on a Scale||Standard Deviation|Mean
135568|NCT00511901|Primary|Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study||8 weeks following randomization|Intention to treat; of the subjects not lost to follow-up, 3 subjects in the placebo arm & 2 subjects in the epoetin alpha arm were not available for 8 week hemoglobin draw||g/dL||Standard Deviation|Mean
135569|NCT00511862|Post-Hoc|2 Year Survival|The percentage of patients in the neuroendocrine group alive at 2 years|24 months from treatment|||percentage of treated subjects|||Number
135570|NCT00511862|Secondary|Overall Survival|Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.|Time from first TheraSphere treatment to death; median follow up 30 months|In the neuroendocrine group, a median overall survival was not achieved so a post-hoc analysis of 2 year survival was performed in Outcome Measure 3.||Months||95% Confidence Interval|Median
135571|NCT00511862|Primary|Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)|Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.|From the date of first treatment until date of first documented progression; median patient follow-up 30 months|Patients receiving at least one TheraSphere treatment with images evaluable by RECIST||Months||95% Confidence Interval|Median
135572|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values in the Reward Circuitry||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.||Percentage (%) of Change||Standard Deviation|Mean
135573|NCT00511836|Primary|Change From Baseline in BOLD Signal Activation Values for the Inferior Frontal Gyrus||14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.||Percentage (%) of Change||Standard Deviation|Mean
135574|NCT00511836|Secondary|Change From Baseline in Daily Craving Score in Alcohol-dependent Subjects (Actiwatch Data)|The Actiwatch-Score device (MiniMitter Co.) was used to collect data on daily alcohol craving. The Actiwatch device is a wrist-worn, battery-operated monitor programmed to beep every 3 hours ±20 minutes, to signal the subjects to enter their alcohol craving or desire to use alcohol at that exact moment on a scale of 0 to 10 units: 0 indicates no craving at all (best score) and 10 indicates extreme craving (worst score). A negative result for Change in Baseline at Day 28 indicates an improvement in daily craving as of 1 month after study drug administration.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had a craving score assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.||Change in Daily Craving Score||Standard Deviation|Mean
135575|NCT00511836|Secondary|Change From Baseline in Obsessive-Compulsive Drinking Scale (OCDS) Score in Alcohol-dependent Subjects|There are 14 items on the Obsessive Compulsive Drinking Scale (OCDS). The scale is scored from 0 to 40 (units). A score of 0 units indicates no obsession-compulsion with respect to alcohol (best score). A score of 40 units indicates maximum obsession-compulsion with respect to alcohol (worst score). A negative Change from Baseline value indicates an improvement. For scoring methods, see: Anton RF, Moak DH, Latham P (1995), The Obsessive Compulsive Drinking Scale: A self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res 19:92-9.|28 days (Baseline to Day 28)|All randomized subjects who received at least 1 dose of study drug and had an Obsessive-Compulsive Drinking Scale (OCDS) assessment at Day 28 were included in this analysis. No last-observation-carried-forward (LOCF) approach was used.||Change in OCDS score||Standard Deviation|Mean
135592|NCT00511797|Secondary|Change From Baseline in Endometrial Thickness After 4-cycle Treatment|Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||mm||Standard Deviation|Mean
135576|NCT00511836|Primary|Change From Baseline in Blood Oxygen-level-dependent (BOLD) Signal Activation Values Detected in the Reward Circuitry of the Brain in Alcohol-dependent Subjects After Presentation of Alcohol-related Cues.|As was standard among fMRI studies conducted at the study site at the time, a change in BOLD signal in the range of 5% to 6% in anterior cingulate as measured using a 3T magnet,is considered highly significant in block-designed experiments.|14 days (Baseline to Day 14)|Analyses include all randomized, dosed subjects who had functional magnetic resolution imaging (fMRI) on Day 14. No data were imputed.||Percentage (%) of Change||Standard Deviation|Mean
135577|NCT00511810|Primary|Mood Symptoms Ratings|Depression symptom severity was determined with the Children’s Depression Rating Scale-Revised (CDRS-R), which is a brief rating scale based on a semi-structured interview with the child. It is a 17-item observer-rated questionnaire where the 17 symptom areas are rated on a 6- or 7-point scale. Total score ranges from a low (not depressed) of 17 to a maximum (very depressed) of 108. Remission was defined as a CDRS-R score of <28. (The total score is the sum of the ratings on each of the 17 items.)|10 weeks|||CDRS-R score||Standard Deviation|Mean
135578|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|The number of subjects without previous medication in DRSP 1 mg/EE 20 μg group was 1, so the standard deviation was not measurable. The number of subjects without previous medication in the other three groups were 0, so the data were not applicable.||scores on a scale||Standard Deviation|Mean
135579|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
135580|NCT00511797|Post-Hoc|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to Cycle 4 (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
135581|NCT00511797|Post-Hoc|Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|From baseline to Cycle 4(28 days per cycle)|FAS (Participants with data at Cycle 4)||scores on a scale||Standard Deviation|Mean
135582|NCT00511797|Secondary|Change From Baseline in Serum Progesterone Level at Cycle 4|Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||ng/mL||Full Range|Mean
135583|NCT00511797|Secondary|Change From Baseline in Serum Estradiol Level After 4-cycle Treatment|Estradiol is a predominant sex hormone that presents in female.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||pg/mL||Full Range|Mean
135584|NCT00511797|Secondary|Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment|CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||mg/dL||Full Range|Mean
135585|NCT00511797|Secondary|Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||Units/L||Full Range|Mean
135586|NCT00511797|Secondary|Participants With Non-heavy Withdrawal Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 dyas per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135587|NCT00511797|Secondary|Participants With Non-heavy Intracyclic Bleeding|Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135588|NCT00511797|Secondary|Participants With Intracyclic Bleeding|Intracyclic bleedings were defined as bleedings while a participant takes active drugs.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135589|NCT00511797|Secondary|Participants With Withdrawal Bleeding|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|At Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135590|NCT00511797|Secondary|Number of Bleeding / Spotting Days|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)||days||Standard Deviation|Mean
135591|NCT00511797|Secondary|Number of Bleeding / Spotting Episodes|Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.|For the first 90 days|FAS (Participants with the defined data)||number of episodes||Standard Deviation|Mean
135612|NCT00511667|Primary|Participants With Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)|||percentage of of participants|||Number
135594|NCT00511797|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||scores on a scale||Standard Deviation|Mean
135595|NCT00511797|Secondary|Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135596|NCT00511797|Secondary|Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135597|NCT00511797|Secondary|Number of Participants With Severity of Headache During Menstruation at Cycle 4|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135598|NCT00511797|Secondary|Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4|Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135599|NCT00511797|Secondary|Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Cycle 4 (28 days per cycle)|FAS (Participants with data at Cycle 4)||participants|||Number
135600|NCT00511797|Secondary|Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.|Baseline and up to 4 Cycles (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
135601|NCT00511797|Primary|Change From Baseline in Total Dysmenorrheal Score at Final Evaluation|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)|Baseline and up to 4 Cycles (28 days per cycle)|FAS||scores on a scale||Standard Deviation|Mean
135602|NCT00511706|Secondary|Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at Screening and Week 25.|Screening (-Week 28), Week 25|Participants from the intent-to-treat population (all randomized participants) with data available at Screening and Week 25 for analyses.||Millimeters square (MM^2)||Standard Deviation|Mean
135603|NCT00511706|Secondary|Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.||Microns||Standard Deviation|Mean
135604|NCT00511706|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 25|Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.||Letters||Standard Deviation|Mean
135605|NCT00511706|Primary|Injection Free Interval|The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator’s determination of eligibility to receive a third ranibizumab injection in the study eye.|Week 1 to Week 25|Intent-to-treat population consisted of all randomized patients.||Days||Inter-Quartile Range|Median
135606|NCT00511667|Primary|Participants Discontinued Because of Any Clinical Adverse Experience||Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)|||participants|||Number
135607|NCT00511667|Secondary|Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||nM||Standard Deviation|Mean
135608|NCT00511667|Secondary|Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||hours||Standard Deviation|Mean
135609|NCT00511667|Secondary|Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||hours||Full Range|Mean
135610|NCT00511667|Secondary|Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||nM||Standard Deviation|Mean
135611|NCT00511667|Secondary|Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941||Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)|||nM-hr||Standard Deviation|Mean
135613|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period|During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.|Outpatient Days 1 to 14|All participants who experienced one or more adverse events during the Outpatient Treatment Period.||participants|||Number
135614|NCT00511472|Secondary|24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7|Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.|24 hours|All participants who had 24-hour weighted mean blood glucose levels evaluated on Day 7||mg/dL||Standard Deviation|Least Squares Mean
135615|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 2|Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 2||participants|||Number
135616|NCT00511472|Secondary|Number of Participants Who Experienced an Adverse Event - Titration Scheme 1|In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study.|25 days|All participants who experienced one or more adverse events within 25 days of Titration Scheme 1||participants|||Number
135617|NCT00511472|Primary|Number of Participants Who Experienced an Adverse Event During the Study||39 days|All participants who experienced one or more adverse events during the study||participants|||Number
135618|NCT00511433|Primary|Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."||IU/L||Standard Deviation|Mean
135619|NCT00511433|Secondary|Average Number of Withdrawal Bleeding Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."||Days||Standard Deviation|Mean
135620|NCT00511433|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||Days||Standard Deviation|Mean
135621|NCT00511433|Primary|Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."||International units per liter (IU/L)||Standard Deviation|Mean
135622|NCT00511433|Primary|Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)|The parameter was measured at pre-defined study days.|Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."||picomoles per liter (pmol/L)||Standard Deviation|Mean
135623|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Progesterone Value|The maximum progesterone value was defined as the largest value during a cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."||nanomoles per liter (nmol/L)||Standard Deviation|Mean
135624|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Maximum Follicle Diameter|The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.|Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."||millimeters (mm)||Standard Deviation|Mean
135625|NCT00511433|Primary|Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation|During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.|Cycle 1, Cycle 2, and Cycle 6|"Intent-to-treat (ITT) group consisted of all participants who were treated.~n=number of participants completing the respective cycle with non-missing values."||Participants|||Number
135626|NCT00511433|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||Participants|||Number
135627|NCT00511433|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||Participants|||Number
135628|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135629|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135630|NCT00511433|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135631|NCT00511433|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135632|NCT00511433|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or without sexual intercourse per diary card data)."||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
135633|NCT00511433|Secondary|Effect on Maximum Endometrial Thickness|Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 6|"ITT group consisted of all participants who were treated.~n=number of participants completing the respective cycle."||mm||Standard Deviation|Mean
135634|NCT00511433|Secondary|Effect on Cervical Mucus as Determined by Insler Score|The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.|Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)|"ITT group consisted of all participants who were treated.~n=number of participants with non-missing values at the respective time point."||score on a scale||Standard Deviation|Mean
135768|NCT00510497|Primary|Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.|AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004|80 weeks|||participants with Grade 3 events related|||Number
135635|NCT00511355|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had withdrawal bleeding/spotting for the respective cycle."||Days||Standard Deviation|Mean
135636|NCT00511355|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had breakthrough bleeding/spotting for the respective cycle."||Days||Standard Error|Mean
135637|NCT00511355|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 5 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||Participants|||Number
135638|NCT00511355|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135639|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135640|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135641|NCT00511355|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135722|NCT00510952|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||Units of insulin/kilograms (U/kg)||Standard Deviation|Mean
135642|NCT00511355|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle."|Every 28-day cycle for 6 cycles|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles."||Participants|||Number
135643|NCT00511355|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|6 cycles|"The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have >=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse per diary card data)."||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
135644|NCT00511355|Secondary|Serum Concentration of Dihydrotestosterone (DHT)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
135645|NCT00511355|Secondary|Serum Concentration of Androstenedione|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
135646|NCT00511355|Primary|Serum Concentration of Thyroxin Binding Globulin (TBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mg/L||Standard Deviation|Mean
135647|NCT00511355|Primary|Serum Concentration of Free Thyroxine (T4)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||pmol/L||Standard Deviation|Mean
135648|NCT00511355|Primary|Serum Concentration of Thyroid Stimulating Hormone (TSH)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mU/L||Standard Deviation|Mean
135649|NCT00511355|Primary|Serum Concentration of Corticosteroid Binding Globulin (CBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline to Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
135650|NCT00511355|Primary|Serum Concentration of Total Cortisol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
135651|NCT00511355|Primary|Serum Concentration of Hemoglobin Type A1c (HbA1c)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of glycosylated hemoglobin||Standard Deviation|Mean
135652|NCT00511355|Primary|Incremental AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*pmol/L||Standard Deviation|Mean
135653|NCT00511355|Primary|AUC3 for Insulin (OGTT)|Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*pmol/L||Standard Deviation|Mean
135669|NCT00511355|Primary|Serum Concentration of Protein S (Total)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
135654|NCT00511355|Primary|Incremental AUC3 for Glucose (OGTT)|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3*fasting concentration. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*mmol/L||Standard Deviation|Mean
135655|NCT00511355|Primary|Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])|Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||hrs*mmol/L||Standard Deviation|Mean
135656|NCT00511355|Primary|Serum Concentration of Total Triglycerides|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
135657|NCT00511355|Primary|Serum Concentration of Lipoprotein(a)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||g/L||Standard Deviation|Mean
135658|NCT00511355|Primary|Serum Concentration of Apolipoprotein B|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||g/L||Standard Deviation|Mean
135659|NCT00511355|Primary|Serum Concentration of Apolipoprotein A-1|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||g/L||Standard Deviation|Mean
135660|NCT00511355|Primary|Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
135661|NCT00511355|Primary|Serum Concentration of HDL3-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
135662|NCT00511355|Primary|Serum Concentration of HDL2-cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
135663|NCT00511355|Primary|Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
135664|NCT00511355|Primary|Serum Concentration of Total Cholesterol|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mmol/L||Standard Deviation|Mean
135665|NCT00511355|Primary|Serum Concentration of C-Reactive Protein (CRP)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mg/L||Standard Deviation|Mean
135666|NCT00511355|Primary|Serum Concentration of Sex Hormone Binding Globulin (SHBG)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
135667|NCT00511355|Primary|APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Ratio||Standard Deviation|Mean
135668|NCT00511355|Primary|Serum Concentration of Protein C|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
135670|NCT00511355|Primary|Serum Concentration of Protein S (Free)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
135671|NCT00511355|Primary|Serum Concentration of Antithrombin III|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
135672|NCT00511355|Primary|Serum Concentration of Clotting Factor II|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
135673|NCT00511355|Primary|Serum Concentration of Clotting Factor VIII|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
135674|NCT00511355|Secondary|Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||umol/L||Standard Deviation|Mean
135675|NCT00511355|Secondary|Serum Concentration of Free Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||pmol/L||Standard Deviation|Mean
135676|NCT00511355|Secondary|Serum Concentration of Total Testosterone|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
135677|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIc|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Percent of normal||Standard Deviation|Mean
135678|NCT00511355|Primary|Serum Concentration of Clotting Factor VIIa|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||U/L||Standard Deviation|Mean
135679|NCT00511355|Primary|Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||Ratio||Standard Deviation|Mean
135680|NCT00511355|Primary|Serum Concentration of D-Dimer|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||mg/L Fibrinogen Equivalent Units (FEU)||Standard Deviation|Mean
135681|NCT00511355|Primary|Serum Concentration of Prothrombin Fragments 1 + 2|Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.|Baseline and Cycle 6 (between Days 15 and 21 of the cycle)|All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6||nmol/L||Standard Deviation|Mean
135682|NCT00511342|Secondary|Average Number of Withdrawal Bleeding-spotting Days|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
135717|NCT00511108|Primary|Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment|Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.||pg*hr/mL||95% Confidence Interval|Least Squares Mean
135683|NCT00511342|Secondary|Average Number of Breakthrough Bleeding-Spotting Days|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if so, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any bleeding/spotting episode that occurred during the “expected non-bleeding period” that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
135684|NCT00511342|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the “expected non-bleeding period” of the next cycle. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."||participants|||Number
135685|NCT00511342|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."||participants|||Number
135686|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the “expected non-bleeding period” that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."||participants|||Number
135687|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the “expected non-bleeding period” that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."||participants|||Number
135688|NCT00511342|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the “expected bleeding period”. Expected bleeding period: LNG-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2 group: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."||participants|||Number
135689|NCT00511342|Primary|Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck|BMD was measured by a Dual Energy X-ray Absorptiometry (DEXA) machine. The Z-score measures the distance of the measured BMD value from the appropriate normal age matched population mean value in units of standard deviation of this population. More negative scores indicate less BMD compared to age matched population, & more positive scores indicate higher BMD compared to age matched population. The adjusted mean change from baseline to the after Cycle 26 visit of the Z-scores is estimated using a baseline-adjusted analysis of covariance (ANCOVA).|Baseline and after cycle 26 (2 years)|All-Subjects-Treated (AST) group consisted of all randomized participants who took at least one dose of trial medication. The number of participants in the AST group with a baseline value and a Week 26 value is presented.||score on a scale||Standard Deviation|Mean
135718|NCT00511004|Secondary|Brugia Specific Immunoglobulin G4 (IgG4) Antibodies|IgG4 antibodies directed against Brugia malayi antigen|2 years|By 2 years, 4 subjects in High Dose Group lost to followup||ng/ml||Full Range|Median
135690|NCT00511342|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting|Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary cards. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the “expected non-bleeding period” that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.|Every 28-day cycle for 26 cycles (2 years total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= Number of participants with evaluable cycles."||participants|||Number
135691|NCT00511342|Secondary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|"Contraceptive efficacy parameter of this trial was the Pearl Index. In-treatment pregnancies were pregnancies with an estimated date of conception from~the day of first intake of trial medication up to and including the day of last(active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant."|2 years (26 cycles)|Restricted Intent-To-Treat (ITT) analysis set included all participants treated, and further excluded non-pregnant participants without at least one cycle expected to be at risk for pregnancy(with recorded use of condoms or without confirmed sexual intercourse, as determined from the electronic diary data).||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
135692|NCT00511238|Secondary|Overall Survival (A1 Only)|The time from start of treatment to death due to any cause OS was to be censored on the date the subject was last known to be alive for those who were alive or lost to follow-up as of a data analysis cutoff date.|Patients were to be followed by telephone contact for disease progression and OS every 3 months after study discontinuation for the first year and every 6 months thereafter for up to 2 years|||months||95% Confidence Interval|Number
135693|NCT00511238|Secondary|Progression-free Survival (A1 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"||months||95% Confidence Interval|Median
135694|NCT00511238|Secondary|Progression-free Survival (A0 Only)|The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.||months||95% Confidence Interval|Median
135695|NCT00511238|Secondary|Time to Progression (A1 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"||months||95% Confidence Interval|Median
135696|NCT00511238|Secondary|Time to Progression (A0 Only)|Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.||months||95% Confidence Interval|Median
135697|NCT00511238|Secondary|Duration of Response (A1 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See overall analysis population description of response-evaluable population above.||months||95% Confidence Interval|Median
135698|NCT00511238|Secondary|Duration of Response (A0 Only)|Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.|Response assessments same as described in primary outcome measure|Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See analysis population description of response-evaluable population above.||days||95% Confidence Interval|Median
135699|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A1 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|"Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"||participants|||Number
135700|NCT00511238|Secondary|Clinical Benefit Response (CBR) (A0 Only)|sCR, CR, VGPR, PR, and minimal response (MR)|Response assessments same as described in primary outcome measure|Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.||participants|||Number
135701|NCT00511238|Primary|Best Overall Response Rate (ORR)|For both A0 and A1, to evaluate the best overall response rate (stringent complete response [sCR]+ complete response [CR]+ very good partial response [VGPR]+ partial response [PR]) in patients with multiple myeloma who had previously received bortezomib and either thalidomide or lenalidomide, had relapsed after two or more therapies, and were refractory to the most recently received therapy|A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.|Analysis population described in reporting groups below||% of participants w/ PR or better||95% Confidence Interval|Number
135702|NCT00511199|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
135703|NCT00511199|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
135704|NCT00511199|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||Participants|||Number
135705|NCT00511199|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||Participants|||Number
135706|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of~the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||Participants|||Number
135707|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||Participants|||Number
135719|NCT00511004|Secondary|Microfilarial Levels at 2 Years|Night time microfilarial levels at 2 years|2 years from time enrolled|By 2 years, 4 subjects in High Dose Group lost to followup||MF/ML||Full Range|Median
135720|NCT00511004|Secondary|Adult Worm Burdens at 2 Years|Doppler detected worm nests at 2 years|2 years from the time enrolled.|By 2 years, 4 subjects in High Dose Group lost to followup||Number of nests||Full Range|Median
135708|NCT00511199|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||participants|||Number
135709|NCT00511199|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||participants|||Number
135710|NCT00511199|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
135711|NCT00511199|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data).||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
135712|NCT00511173|Primary|In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).|Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).|six months|power analysis based on data from Sconce, et al.||mg/wk||Standard Deviation|Mean
135713|NCT00511134|Secondary|Smoking Abstinence as Measured by Self Reported Smoking and Confirmed by CO Level|Endpoint abstinence will be defined as 0 cigarettes over the seven days prior to the subject’s Timeline Follow-Back evaluation at the end of week 7 (end of trial) and a Carbon Monoxide (CO) level ≤ 5.|6 weeks after target smoking quite date|||participants|||Number
135714|NCT00511134|Primary|Level of Insomnia as Measured by the Insomnia Severity Index|Insomnia Severity Index (ISI): 13-item self-report measure which examines symptoms of insomnia, consequences of insomnia, and subjective distress related to sleep problems. Subjects rate the symptoms and consequences of insomnia on a 5 point Likert scales. For example, subjects are asked to rate the severity of their insomnia (e.g., difficulty falling asleep from 0=none to 4=very severe). Scores on the first 7 items are summed for a total insomnia score ranging from 0-28.|6 weeks after target smoking quit date|Baseline descriptive data was examined for the 4 participants. Outcome measures were available for 2 participants. Due to the small number of participants, statistical comparisons were not able to be performed.||Units on a Scale||Full Range|Median
135715|NCT00511108|Secondary|Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment|Glucose concentration was measured at 11 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.||mg*hr/dL||95% Confidence Interval|Least Squares Mean
135716|NCT00511108|Primary|Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment|"Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state.~Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100."|Baseline and 12 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last observed measurement was carried forward to Week 12.||Percent Change||95% Confidence Interval|Least Squares Mean
135721|NCT00511004|Primary|Microfilarial Counts at 1 Year|Night time microfilarial counts at 1 year|1 year from time enrolled|||MF/ML||Full Range|Median
135723|NCT00510952|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||Units of insulin||Standard Deviation|Mean
135724|NCT00510952|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||kilograms (kg)||Standard Deviation|Mean
135725|NCT00510952|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||hypoglycemic events per 30 days||Standard Deviation|Mean
135726|NCT00510952|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||hypoglycemic event per 1 year||Standard Deviation|Mean
135727|NCT00510952|Secondary|Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||participants|||Number
135728|NCT00510952|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint|Actual measurements and daily mean blood glucose levels at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||millimoles per liter (mmol/L)||Standard Deviation|Mean
135729|NCT00510952|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||millimoles per liter (mmol/L)||Standard Deviation|Mean
135730|NCT00510952|Secondary|Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.|24 weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||percentage of participants|||Number
135731|NCT00510952|Secondary|Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement.||percent hemoglobin||Standard Error|Least Squares Mean
135732|NCT00510952|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and had at least one post-baseline measurement. Last observation carried forward.||percent of HbA1c||Standard Error|Least Squares Mean
135733|NCT00510887|Secondary|Number of Participants With Neuropathy, Any Grade|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year|||participants|||Number
135734|NCT00510887|Secondary|Number of Participants With a Grade 3-4 Hematologic Toxicity.|Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s). Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).|up to 1 year|||participants|||Number
135735|NCT00510887|Secondary|Percentage of Subjects Experiencing Overall Survival|Overall survival is from the day of enrollment to date of death from any cause.|up to 2 years|||percentage of participants|||Number
135736|NCT00510887|Secondary|Percentage of Subjects Experiencing Progression Free Survival|Progression free survival is measured from treatment to progression or death, whichever comes first. Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment.|up to 2 years|||percentage of participants|||Number
135737|NCT00510887|Secondary|Duration of Response|Duration of response is measured from time of treatment to time of disease progression|up to 4 years|||months||Full Range|Mean
135749|NCT00510874|Primary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
135738|NCT00510887|Primary|Complete and Partial Response|"Complete Response: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms and normalization of biochemical abnormalities (eg. LDH) definitely assignable to follicular lymphoma.~Partial Response requires the following:~greater than or equal to 50% decrease in the SPD of the 6 largest dominant nodes of nodal masses.~No increase in size of other nodes, liver, or spleen.~Splenic and hepatic nodes must regress by at least 50% in sum of the products (SPD).~Bone marrow assessment in irrelevant for determination of Partial Response since it is not measurable disease; however, if positive the type of cell should be reported.~No new lesions."|1 year|||percentage of participants|||Number
135739|NCT00510874|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.|At Days 0, 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
135740|NCT00510874|Secondary|Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Fold increase||95% Confidence Interval|Geometric Mean
135741|NCT00510874|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Days 21 and 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
135742|NCT00510874|Secondary|Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 21 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Titers||95% Confidence Interval|Geometric Mean
135743|NCT00510874|Primary|Number of Subjects With Any Serious Adverse Events (SAEs).|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
135744|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Between Day 0 and Day 84 after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
135745|NCT00510874|Primary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day follow-up period (Days 0-20) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
135746|NCT00510874|Primary|Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).|A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.|From Day 0 to 182|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
135747|NCT00510874|Primary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
135748|NCT00510874|Primary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).|Within the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.||Subjects|||Number
140498|NCT00465101|Other Pre-specified|Length of Lasing (LOL)|Total time the laser was on during the study procedure.|Procedure|Participants who received the study treatment and for whom the outcome measure is available.||minutes||Standard Deviation|Mean
135750|NCT00510874|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Titers||95% Confidence Interval|Geometric Mean
135751|NCT00510874|Primary|Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.||Subjects|||Number
135752|NCT00510835|Secondary|Resource Use and Costs of Alternative Resuscitation Strategies||at discharge or 60 days, whichever comes first||||||
135753|NCT00510835|Secondary|Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis.||study hour 0, 6, 24 & 72||||||
135754|NCT00510835|Primary|Hospital Mortality|The primary study outcome is hospital mortality (defined as the number of deaths prior to discharge or 60 days, whichever comes first). The secondary outcomes are duration of survival (90 day and 1 year) and clinical evidence of organ dysfunction.|prior to discharge or 60 days, whichever comes first|||Participants|||Count of Participants
135755|NCT00510809|Secondary|Adverse Events Reported|All events reported that were deemed to be related, or unrelated, to the study drug.|Week 8|||number of events reported|||Number
135756|NCT00510809|Primary|Lipid Profile||Change between Week 8 and Baseline|||mg/dl||Standard Error|Mean
135757|NCT00510783|Primary|Number of Participants Who Experienced a Recurrent Seizure After Treatment.|Recurrent seizure is defined as a seizure within 24 hours of treatment in the Emergency Department.|24 hours|||participants|||Number
135758|NCT00510744|Primary|Fat Absorption|72 hour fat absorption study|3 months|each patients as their own control, baseline fat absorption vs post 3 month enzyme supplementation fat absorption||g/d||Standard Error|Mean
135759|NCT00510692|Secondary|Number of Subjects With Adverse Events.|Incidence of adverse events in each treatment group.|6 months compared to baseline|||participants|||Number
135760|NCT00510692|Secondary|Relative EPA Concentration of Total Free Fatty Acids in the Rectal Mucosa.|Relative EPA concentration of total free fatty acids in the rectal mucosa of subjects with FAP.|6 months compared to baseline.|3 subjects in the full analysis set had no samples for analysis.||percentage of total fatty acid content||95% Confidence Interval|Mean
135761|NCT00510692|Secondary|Change in Global Rectal Polyp Burden.|"Change in global rectal polyp burden in subjects treated with Eicosapentanoic Acid (EPA) compared to subjects receiving placebo. Each reviewer in the Polyp Video Scoring Committee assessed global colorectal polyp burden change as better, same as or worse. The qualitative assessment was assigned a score of +1 for better, 0 for same as and -1 for worse. Thereafter a mean overall reviewers score was calculated."|6 months compared to baseline.|5 subjects in the full analysis set lacked the video required for determining global rectal polyp burden due to failure of equipment.||units on a scale||95% Confidence Interval|Mean
135762|NCT00510692|Secondary|Percentage Change in the Number of Polyps Measured in the Defined Focal Area of the Rectum.|Percentage change in the number of polyps measured in the defined focal area of the rectum in subjects treated with EPA compared to subjects receiving placebo.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.||percentage of change in total polyps||95% Confidence Interval|Mean
135763|NCT00510692|Primary|Absolute Change in the Number of Polyps Measured in a Focal Area of the Rectum.|Absolute change in the number of polyps measured in a defined focal area of the rectum.|6 months compared to baseline.|13 subjects lacked the photographs required for counting the measurements of polyps. Reasons for lack of photographs varied including failure of video equipment, inability to identify identical views of the focal area and no forceps visible for calibration.||Change from baseline number of polyps.||Standard Deviation|Mean
135764|NCT00510653|Primary|Overall Response Rate (ORR)|ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): >/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or > increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.|6 weeks with re-evaluation every 6 weeks or until disease progression|Two participants were not evaluable for response: in 1 participant, early toxicity caused discontinuation of the drug, and the other patient had an intestinal obstruction requiring palliative surgery after 1 day of therapy.||participants|||Number
135765|NCT00510510|Secondary|Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day|Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.|28 Days|||Liters||Standard Error|Least Squares Mean
135766|NCT00510510|Primary|Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)|The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.|28 days|||Participants|||Number
135767|NCT00510497|Secondary|Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)|Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption|at the end of 12 weeks treatment interruption|||log10 HIV RNA||Full Range|Median
135769|NCT00510484|Secondary|Percentage of Days With no Abdominal Pain.|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
135770|NCT00510484|Secondary|Percentage of Days With no Flatulence.|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
135771|NCT00510484|Other Pre-specified|Percentage of Days With Formed/Normal Stools.|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage of days||Standard Deviation|Mean
135772|NCT00510484|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Number per day||Standard Deviation|Mean
135773|NCT00510484|Secondary|Total Stool Weight (Grams)|Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
135774|NCT00510484|Secondary|Total Fat Excretion (Grams)|Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Grams||Standard Deviation|Mean
135775|NCT00510484|Secondary|Coefficient of Nitrogen Absorption (%)|This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
135776|NCT00510484|Primary|Coefficient of Fat Absorption (%)|This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.|5 days|The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.||Percentage||Standard Deviation|Mean
135777|NCT00510289|Secondary|Change in Microvessel Density|Microvessel density will be measured before and after treatment, and the distribution of change across time will be summarized with descriptive statistics.|Measured before and after treatment|This outcome was not analysed due to the early closure of the study.|||||
135778|NCT00510289|Secondary|Overall Survival|Overall Survival is defined as the number of months from enrollment onto the study until death from any cause in subjects who took study drug for at least cycle 1.|1 year from the last dose of study drug|7 subjects completed cycle 1 or beyond.||months||Full Range|Mean
135779|NCT00510289|Secondary|Time to Progression|Time to progression will be defined as the number of months between on-study and the date of progression or death, whichever comes first, in subjects who took study drug for at least cycle 1.|5 years|7 patients completed cycle one and had bone marrow biopsies to confirm response.||months||Full Range|Median
135780|NCT00510289|Secondary|Number of Subjects Requiring Dose Reductions|The number of subjects who took study drug for more than 1 cycle and required a dose reduction down to the next dose level.|While on study drug, a maximum of 5 years|7 Subjects completed beyond cycle 1. 4 of those subjects had dose reductions during the time they took study drug.||participants|||Number
135781|NCT00510289|Primary|Number of Subjects Achieving Hematological Response|Hematological response is defined as the number of subjects who achieve either a complete response (CR), Partial response (PR) or Hematologic improvement.(HI). HI is defined as peripheral blood counts with hemoglobin ≥11 g/dL, absolute neutrophil count ≥1x10(9)/L and platelet count ≥100x10(9)/L, and normal bone marrow morphology with no evidence of dysplasia or blasts. CR is defined as the disappearance of all signs and symptoms related to disease, along with HI. PR is defined as fulfilling the criteria for CR in the peripheral blood but blasts decreasing by 50% or more in the bone marrow or to a less advanced WHO classification pretreatment.|During treatment - up to a maximum of 5 years|There were 16 subjects enrolled in the trial. 9 subjects refused further bone marrow biopsy to assess response to therapy. Therefore, there were 7 evaluable subjects. One subject experienced PR||participants|||Number
135782|NCT00510276|Secondary|Strong Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||participants|||Number
135829|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimole/Liter||Standard Deviation|Mean
136121|NCT00507559|Secondary|Effectiveness: Prosthesis Migration|Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure|12 months|The denominator is the number of subjects with adequate CT imaging available at 12 months||participants|||Number
135783|NCT00510276|Secondary|Responders by Baseline Smoking Status|Baseline smoking status was recorded and associations to response to treatment were determined. Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||participants|||Number
135784|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)|Used to determine the level of daytime sleepiness. The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities. Subjects rate the likelihood of dozing off or falling asleep in each of these situations. Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing). The item scores are summed to produce a total score (range of 0-24). Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135785|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section|The BRIEF-A Working Memory assesses an individuals' memory function in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135786|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section|The BRIEF-A Task Monitor assesses an individuals's ability to monitor a task in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135787|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section|The BRIEF-A Self Monitor assesses an individuals' capacity to self monitor in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135788|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section|The BRIEF-A Shift assess an individuals' shifting between different behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135789|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section|The BRIEF-A Plan/Organize asseses an individuals' capabilities to plan and organize in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135805|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of joints that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of joints per day||Standard Error|Least Squares Mean
135790|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section|The BRIEF-A Organization of Materials assesses an individuals' organizing skills in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135791|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section|The BRIEF-A Negativity asseses an indivduals' perceived negativity in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 10.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135792|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section|BRIEF-A Metacognition subscale is a standardized measure assessing individual's ability to systematically solve problems via planning and organization while sustaining these task-completion efforts in active working memory. Form is designed to be completed by adults, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior never observed, 2=behavior sometimes observed, and 3=behavior often observed - higher ratings indicate greater perceived impairment. Total score ranges from 40 to 120.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135793|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section|The BRIEF-A Initiate rates an individual's initiative behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135794|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section|The BRIEF-A Inhibit rates an individual's inhibition in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135795|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section|Standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which respondent answers additional items in an unusual and infrequent direction. Form is designed to be completed by adults 18-90 years of age, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. Total score ranges from 0 to 5.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135796|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section|The BRIEF-A Inconsistency rates the behavioral inconsistency displayed by the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 20.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135826|NCT00510146|Secondary|Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).|Endpoint (Week 24)|Total participants in the open-label extension phase.||percentage of participants|||Number
135797|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score|The BRIEF-A GEC rates the global executive composite of the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 75 to 225.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135798|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score|The BRIEF-A emotional control subscale assesses an individuals emotional control in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135799|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score|The BRIEF-A behavioral regulation subscale measures an individuals control over behavior in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 30 to 90.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135800|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report|26-item driving survey completed by someone other than the patient/driver. Examples of driving behaviors included in the survey match those listed in the Self-Report version of the scale. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items and ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135801|NCT00510276|Primary|Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint|CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, Week 12|Intent-to-treat population was analyzed, including all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135802|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report|26 item self-rated driving survey with examples of driving behaviors, e.g.: putting on seat belt, driving within speed limits, yielding the right of way to other drivers. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items. A driving history is completed by self-report the first time a rater completes the Driving Behavior Survey (Self-Report). The total score ranges from 26 to 104.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135803|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)|Patient completed scale that consists of 21 items that examine behavior and subjective perception, including satisfaction, self-perception and motivation in participating in and maintaining relationships with family and friends, satisfaction in work, home and leisure activities, and intellectual interests. Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range from 0 to 60.|Baseline, 12 weeks|Analyzed was a intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135804|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)|The FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135827|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||beats per minute||Standard Deviation|Mean
135806|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of nicotine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of nicotine products per day||Standard Error|Least Squares Mean
135807|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of recreational drugs other than marijuana an individual consumed and is expressed as the ratio of number of days on which drugs were used over the total number of days, resulting in a total score ranging from 0 to 1. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||ratio||Standard Deviation|Mean
135808|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of caffeine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of caffeinated drinks per day||Standard Error|Least Squares Mean
135809|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol|Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||number of alcoholic drinks per day||Standard Error|Least Squares Mean
135810|NCT00510276|Secondary|Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score|"AAQOL-29: Patient-reported outcome measure examining disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.~CAARS-Inv:SV: Inattention subscale, Impulsivity subscale, and ADHD Index. Each item is scored on a 0 to 3 scale, assessing symptom severity over the past week. The total score is the sum of all subscale scores."|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||correlation coefficient|||Number
135811|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)|21-item self-reported screening tool for measuring anxiety severity. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely; I could barely stand it). Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Patients record how much they have been bothered by each symptom during the past week, including the day the questionnaire is administered. The total score ranges from 0 to 63.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135812|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)|Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135813|NCT00510276|Secondary|Endpoint Scores in Patient Global Impression - Improvement (PGI-I)|7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse).|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135828|NCT00510146|Secondary|Change From Baseline to Endpoint in ECG (Open-Label Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||milliseconds||Standard Deviation|Mean
136122|NCT00507559|Secondary|Effectiveness: EndoStaple Stent/Fracture|Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure|12 months|Denominator is number of subjects with adequate x-ray imaging available at 12 months||participants|||Number
135814|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score|30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54.|Baseline, 12 weeks|An intent-to-treat population was analyzed using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135815|NCT00510276|Secondary|Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)|Single-item clinician rating of the clinician’s assessment of the patient’s severity of the ADHD symptoms in relation to the clinician’s total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7.|Baseline, 12 weeks|Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135816|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135817|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135818|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale|"Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135819|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Intent-to-treat population was used for analysis. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135820|NCT00510276|Secondary|Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score|"Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from not at all/never=1 to extremely/very often=5. The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning."|Baseline, 12 weeks|Analyzed was an intent-to-treat population. Included were all randomized patients who had both a baseline and at least 1 post baseline score.||units on a scale||Standard Error|Least Squares Mean
135821|NCT00510224|Secondary|Pre Versus Post Treatment Mitogenic Effects.||12 Weeks|The trial was closed for futility after no PSA responses were observed among the first 13 patients, and this analysis was not performed|||||
135822|NCT00510224|Secondary|Grade 4-5 Adverse Events||12 weeks|||Adverse Events|||Number
135823|NCT00510224|Secondary|Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.|Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).|Baseline, 12 weeks|||percent change||Full Range|Median
135824|NCT00510224|Primary|PSA Response|Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.|12 weeks|n=27 was determined to be sufficient to test for a 20% PSA response proportion compared with a null hypothesis of 5%. A two-stage design was employed to carry out an interim analysis for efficacy. As no patient showed a PSA decline among the first 13 accrued after 3 cycles (the first evaluation of PSA response), accrual was discontinued||Participants|||Number
135825|NCT00510146|Secondary|Number of Participants With Adverse Events (Open-Label Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.||participants|||Number
135830|NCT00510146|Secondary|Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||micromole/Liter||Standard Deviation|Mean
135831|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||microgram/Liter||Standard Deviation|Mean
135832|NCT00510146|Secondary|Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||billion cells per liter (BILL/L)||Standard Deviation|Mean
135833|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimole/Liter of iron (Fe)||Standard Deviation|Mean
135834|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||trillion cells per liter (Tril/L)||Standard Deviation|Mean
135835|NCT00510146|Secondary|Change From Baseline to Endpoint in Creatinine (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||micromole/Liter||Standard Deviation|Mean
135836|NCT00510146|Secondary|Change From Baseline to Endpoint in Chloride (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimole/Liter||Standard Deviation|Mean
135837|NCT00510146|Secondary|Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||units/Liter||Standard Deviation|Mean
135838|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||gram/Liter||Standard Deviation|Mean
135839|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Open-Label Phase)||Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||kilograms||Standard Deviation|Mean
135840|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)||Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||millimeters of mercury||Standard Deviation|Mean
135841|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 24)|Participants who entered Open-Label Phase with a normal baseline and at least one post-baseline result.||percentage of participants|||Number
135842|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.||percentage of participants|||Number
135843|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline (End of Acute Phase/Week 6), Endpoint (Week 24)|Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
135844|NCT00510146|Secondary|Percentage of Participants With Recovery (Open-Label Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.||percentage of participants|||Number
135845|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in open-label extension phase.||percentage of participants|||Number
135846|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score.|Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24)|Total participants in the open-label extension phase.||percentage of participants|||Number
135847|NCT00510146|Secondary|Number of Participants With Adverse Events (Acute Phase)|Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.|Baseline through Week 6 (Acute Phase)|All enrolled participants in Acute Phase||participants|||Number
135848|NCT00510146|Secondary|Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)|The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors.|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
135849|NCT00510146|Secondary|Change From Baseline to Endpoint in Heart Rate (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||beats per minute (bpm)||Standard Deviation|Mean
135850|NCT00510146|Secondary|Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)|Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).|Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||milliseconds||Standard Deviation|Mean
135851|NCT00510146|Secondary|Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||ratio||Standard Deviation|Mean
135852|NCT00510146|Secondary|Change From Baseline to Endpoint in Prolactin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||microgram/Liter||Standard Deviation|Mean
135853|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||millimole/Liter of iron (Fe)||Standard Deviation|Mean
135854|NCT00510146|Secondary|Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percent of glycosylated hemoglobin||Standard Deviation|Mean
135855|NCT00510146|Secondary|Change From Baseline to Endpoint in Hematocrit (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||proportion of blood volume||Standard Deviation|Mean
135856|NCT00510146|Secondary|Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||trillion cells per liter ( TRIL/L)||Standard Deviation|Mean
135857|NCT00510146|Secondary|Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||micromole/Liter||Standard Deviation|Mean
135858|NCT00510146|Secondary|Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||units/Liter||Standard Deviation|Mean
135859|NCT00510146|Secondary|Change From Baseline to Endpoint in Albumin (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||gram/Liter||Standard Deviation|Mean
135860|NCT00510146|Secondary|Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||millimole/Liter||Standard Deviation|Mean
135861|NCT00510146|Secondary|Change From Baseline to Endpoint in Weight (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||kilograms||Standard Deviation|Mean
135862|NCT00510146|Secondary|Change From Baseline to Endpoint in Blood Pressure (Acute Phase)||Baseline, Endpoint (Week 6)|Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||mmHg (millimeters of mercury)||Standard Deviation|Mean
135863|NCT00510146|Secondary|Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)|EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.|Endpoint (Week 6)|Participants with a normal baseline and an endpoint result.||percentage of participants|||Number
135864|NCT00510146|Secondary|Percentage of Participants With Emergence of Mania During the Study (Acute Phase)|Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population||percentage of participants|||Number
135865|NCT00510146|Secondary|Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)|In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
135866|NCT00510146|Secondary|Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)|In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
135867|NCT00510146|Secondary|Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)|In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
135868|NCT00510146|Secondary|Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)|In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
135869|NCT00510146|Secondary|Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)|In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features.|Endpoint (Week 6)|Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).||percentage of participants|||Number
135870|NCT00510146|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase)|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
135871|NCT00510146|Secondary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
135872|NCT00510146|Secondary|Percentage of Participants With Recovery (Acute Phase)|Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6 )|Intention-to-treat (ITT) population; all randomized participants.||percentage of participants|||Number
135873|NCT00510146|Secondary|Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)|CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
135874|NCT00510146|Secondary|Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)|Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.||percentage of participants|||Number
135875|NCT00510146|Secondary|Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)|Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Endpoint (Week 6)|Intention-to-treat (ITT) population; all randomized participants.||percentage of participants|||Number
135876|NCT00510146|Primary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Endpoint (Week 6)|Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF)||units on a scale||Standard Deviation|Mean
135877|NCT00510068|Secondary|Plasma Angiogenesis Marker: Vascular Endothelial Growth Factor (VEGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
135878|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
135879|NCT00510068|Secondary|Plasma Angiogenesis Marker: Soluble Vascular Endothelial Growth Factor Receptor 1 (sVEGFR1)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
135880|NCT00510068|Secondary|Plasma Angiogenesis Marker: Placental Growth Factor (PLGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
135881|NCT00510068|Secondary|Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)|This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.|Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1|The Full Analysis Set (FAS) consists of all patients who were randomized.||pg/mL||Standard Deviation|Mean
135882|NCT00510068|Secondary|Analysis of Time to Definitive Deterioration of WHO Performance Status Using Kaplan-Meier|Time to definitive worsening is defined as a definitive increase in performance status from a baseline of 0 or 1 to WHO >= 2, or from a baseline value of 2 to WHO >= 3. If no earlier deterioration, patients were censored at the end of follow-up or at the start of further antineoplastic therapy. Rates of patients with no deterioration at 3 and 6 months were computed using Kaplan-meier method. Grade 0: Able to carry out all activity without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to do light work; Grade 2: Ambulatory & capable of all self-care but unable to carry out any work. Up & about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled & cannot carry on any self-care; totally confined to bed or chair.|3 months, 6 months|The Full Analysis Set (FAS) consists of all patients who were randomized.||% of participants with no deterioration|||Number
135883|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. Values for tmax where summarized in median (range).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||h||Full Range|Median
135884|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: CL/F|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||L/h||Standard Deviation|Mean
135885|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||ng/mL||Standard Deviation|Mean
135886|NCT00510068|Secondary|Evaluation of Pharmacokinetics (PK) Parameter: AUC0-t Last|The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. This PK parameter is area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t last).|Day 1 of every cycle (28 days/cycle) throughout the study|The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.||ng.h/mL||Standard Deviation|Mean
135887|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) (Open-label Period)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of open-label study medication until no later than 28 days after open-label study medication discontinuation|The open-label set was used to summarize the safety analyses performed on data collected in the open-label period of the study: the open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.||Participants|||Number
135897|NCT00509925|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (FPG) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||mmol/L||Standard Deviation|Mean
136187|NCT00503984|Secondary|Overall Survival (OS)|The time from the date of initiation of study treatment until date of death from any cause.|Up to 4.5 years.|||months||95% Confidence Interval|Median
135888|NCT00510068|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation|The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment.||Participants|||Number
135889|NCT00510068|Secondary|Progression Free Survival According to Neuron Specific Enolase Tumor Marker (NSE) Baseline Level and According to NSE Early Response|"Baseline levels of serum NSE were characterized towards PFS as per local investigator assessment, relative to the upper limited of normal (ULN). NSE levels exceeding ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An ‘early response’ (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. NSE is widely expressed in well-differentiated pancreatic NET. NSE is usually expressed in the cytoplasm. Pancreatic NET patients often present with elevated circulating levels of NSE in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.||Months||95% Confidence Interval|Median
135890|NCT00510068|Secondary|Progression Free Survival According to Chromogramin A Tumor Marker (CgA) Baseline Level and According to CgA Early Response|"Baseline levels of serum CgA SE were characterized towards progression free survival (PFS) as per local investigator assessment, relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated' otherwise considered as Non-elevated. An ‘early response’ (applicable to only those patients with elevated levels at baseline) was defined as a decrease of greater than or equal to 30% from baseline to Cycle 2 Day 1 or normalization by Cycle 2 Day 1. CgA is widely expressed in well-differentiated pancreatic NET. CgA is present in the secretory granules of neuroendocrine cells. Pancreatic NET patients often present with elevated circulating levels of CgA in their blood. Baseline levels of these biomarkers are considered as prognostic factors."|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.||Months||95% Confidence Interval|Median
135891|NCT00510068|Secondary|Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%|The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, > 2% to less than or equal to 5% and > 5%.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consisted of all patients who were randomized.||Months||95% Confidence Interval|Median
135892|NCT00510068|Secondary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.|Baseline, to death- no time limit|The Full Analysis Set (FAS) included all randomized patients.||Months||95% Confidence Interval|Median
135893|NCT00510068|Secondary|Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})|Objective Response defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of the longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks . Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.||Percentage of participants||95% Confidence Interval|Number
135894|NCT00510068|Primary|Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology|Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010|The Full Analysis Set (FAS) consists of all patients who were randomized.||Months||95% Confidence Interval|Median
135895|NCT00509925|Secondary|Hypoglycaemic Episodes, Diurnal/Nocturnal|Total number of hypoglycaemic episodes during the day (diurnal) and the night (nocturnal) experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.||episodes|||Number
135896|NCT00509925|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in the study.|Weeks 0-32|The safety analysis set included all randomised and exposed subjects.||episodes|||Number
136188|NCT00503984|Secondary|Progression-Free Survival (PFS)|The time from the date of start of treatment until the first documented or confirmed disease progression, or death related to prostate cancer, whichever is earlier.|Up to 4.5 years|||months||95% Confidence Interval|Median
135898|NCT00509925|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||percentage of total haemoglobin||Standard Deviation|Mean
135899|NCT00509925|Secondary|Hormonal Assessment: Leptin|Leptin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
135900|NCT00509925|Secondary|Hormonal Assessment: Resistin|Resistin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
135901|NCT00509925|Secondary|Hormonal Assessment: Insulin-like Growth Factor-1|Insulin-like growth factor-1 (IGF-1) levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
135902|NCT00509925|Secondary|Hormonal Assessment: Adiponectin|Adiponectin levels after each treatment period.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||ng/ml||Standard Deviation|Mean
135903|NCT00509925|Secondary|Waist:Hip Ratio|At each time-point, 3 measurements each of waist and hip circumference were taken, then an average across the three measurements was calculated for both and the ratio was calculated as the waist average in cm divided by hip average in cm, and multiplied by 100.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||percentage of hip circumference||Standard Deviation|Mean
135904|NCT00509925|Secondary|Fat Mass|Fat mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kg||Standard Deviation|Mean
135905|NCT00509925|Secondary|Lean Body Mass|Lean body mass was measured using Bioelectrical Impedance Analysis (BIA), a method used for estimating body composition.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kg||Standard Deviation|Mean
135906|NCT00509925|Secondary|Body Weight|Body weight after each treatment period.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kg||Standard Deviation|Mean
135907|NCT00509925|Secondary|Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT)|Non-exercise activity thermogenesis is a component of TEE (total energy expenditure). Thermic efficiency was assessed by measuring O2 consumption/CO2 production while the subject exercised on a bike for 20 minutes while hooked up to a device that recorded their respiration (visit in week 14 and week 30). If thermic efficiency was unchanged and volitional exercise was unchanged, then any change in physical activity thermogenesis was due to changes in NEAT.|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
135908|NCT00509925|Secondary|Component of Total Energy Expenditure: Physical Activity Thermogenesis|Physical activity thermogenesis is a component of TEE (total energy expenditure). Subjects were asked not to change their physical activity levels. Physical activity thermogenesis can be calculated as the difference between TEE minus (REE + DIT), as long as volitional exercise is unchanged. Volitional exercise was assessed using Actiheart 3-D monitor readings. Subjects were asked to measure their normal activity for between 1 and 5 days prior to their visits at week 16 and week 32).|Week 16, week 32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
135909|NCT00509925|Primary|Total Energy Expenditure, Dietary Record Method|The total energy expenditure (TEE) measured after each treatment period by the dietary record method. The calculation of energy balance is accomplished by compiling an accurate record of food intake over a period of time and measuring any changes in body weight that occur during that time. Data from the 7-day food diary was used to calculate TEE.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
135910|NCT00509925|Secondary|Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT)|Diet induced thermogenesis (DIT) is a component of TEE (total energy expenditure) and is the energy expenditure following feeding for anabolic processes. Subjects fasted overnight and rested for 1 hour. Multiple measurements of REE (resting energy expenditure) were taken. A fixed 600 kcal liquid meal was given and REE was measured over the next 3 hours. DIT was calculated as area under the curve of total REE-resting REE for the 3-hour period and was then converted to a per day measurement by taking into account each individual’s average daily food intake.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
135911|NCT00509925|Secondary|Component of Total Energy Expenditure: Resting Energy Expenditure (REE)|Resting energy expenditure (REE) is a component of TEE (total energy expenditure). It was measured at 2 different timepoints during the trial using indirect calorimetry (measurement of O2 consumption/CO2 production) after an overnight fast when subjects would be metabolising a mixture of carbohydrate and free fatty acid. This technique allowed the calculation of the rate of carbohydrate and lipid oxidation.|Week 14, week 30|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
135912|NCT00509925|Primary|Total Energy Expenditure, Double-labelled Water Method|Total energy expenditure (TEE) measured after each treatment period by the double-labelled water (DLW) method. This technique required subjects to label their body water using oral administration of water labelled with 2 stable isotopes (2H218O). The clearance of 2H and 18O was measured over a two week period with daily collections of urine. The difference between the clearance of 2H and 18O is a measure of CO2 production rate. This can be converted to provide a measure of energy expenditure.|Weeks 14-16, weeks 30-32|The analysis was performed on an ITT (Intent-to-Treat) analysis set. The ITT analysis set consisted of all subjects who received at least one post-treatment value of the primary endpoint.||kcal/day||Standard Deviation|Mean
135913|NCT00509899|Secondary|Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG performance status measures patients' functional status on the following scale:~0=Fully active, no restrictions;~1=Restricted in physically strenuous activity but ambulatory, able to carry out light work;~2=Ambulatory and capable of all selfcare, unable to carry out any work activities; Up and about > 50% of waking hours;~3=Limited selfcare, confined to bed or chair more than 50% of waking hours;~4=Completely disabled. Totally confined to bed or chair;~5=Dead.~Data reported indicate the number of participants with a change from Baseline score of -2, -1, 0 and 1."|Baseline and Week 24|Intent-to-treat population for patients who had reached each time point and for whom data was available.||participants|||Number
135914|NCT00509899|Secondary|Change From Baseline in Body Weight Over Time||Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.|Intent-to-treat population for patients who had reached each time point and for whom data was available.||kg||Standard Deviation|Mean
135915|NCT00509899|Secondary|Change From Baseline to Week 24 in Health-Related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 24|The safety population included all subjects who received at least 1 dose of study medication, and for whom data was available at both time points. The EORTC QLQ C30 was implemented by protocol amendment and as a result this data are available for only approximately 50% of the enrolled patients.||units on a scale||Standard Deviation|Mean
135916|NCT00509899|Secondary|Change From Baseline in Myelofibrosis Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF). Abdominal discomfort, itching, muscle or bone pain, and night sweats are prominent and troubling symptoms in patients with MF. Therefore, the MFSAF-derived responses for these symptoms were analyzed as a total symptom score. Each symptom was assessed on a scale from 0 (absent), 1 (most favorable) to 10 (worst). The total symptom score is a sum of the individual scores and ranges from 0-40. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population for whom data was available. The MFSAF was implemented by protocol amendment while the study was ongoing. Hence data are available for only approximately 50% of enrolled patients. This analysis includes patients with a Baseline total symptom score ≥ 0; 8 patients were excluded because they had a Baseline score = 0.||scores on a scale||Standard Deviation|Mean
135917|NCT00509899|Secondary|Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time|"Spleen volume was assessed in a subgroup of 27 patients using magnetic resonance imaging (MRI) scans (or computed tomography (CT) scans in patients who were not candidates for MRI) of the abdomen in order to allow objective measurement of spleen volume using standard estimation techniques.~For each visit, patients who had a missing value at the visit or dropped out of the study due to any reason prior to the visit were considered as not having achieved the ≥35% reduction in spleen volume."|Baseline, Weeks 4, 12, 24 and 48|Patients with at least 1 Spleen-Volume Measurement. Patients who had not reached the visit were excluded from the analysis. In addition, at Week 48, 5 patients who did not have MRI measurement due to a protocol amendment were considered as not evaluable and were excluded from the analysis.||percentage of participants|||Number
135918|NCT00509899|Secondary|Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time|For each visit, patients who had a missing value at the visit, dropped out of the study due to any reasons prior to the visit or had non-palpable spleen at baseline and then became palpable at the time of the visit were all considered as having not achieved the ≥ 50% reduction in spleen palpation length.|Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60|Intent to treat population. A total of 16 patients had either a splenectomy prior to study entry, missing Baseline spleen values or had spleen lengths reported as 0 cm and were excluded.||percentage of participants|||Number
135919|NCT00509899|Primary|Percentage of Participants With Clinical Improvement (CI) Over Time|"Clinical improvement was defined according to the International Working Group Myelofibrosis Research and Treatment criteria, and required 1 of the following:~A ≥ 2 g/dL increase in Hemoglobin level or becoming transfusion independent;~Either a ≥ 50% reduction in palpable splenomegaly if spleen was ≥ 10 cm at Baseline or a spleen palpable at > 5 cm at Baseline becomes not palpable;~A ≥ 100% increase in platelet count and an absolute platelet count of ≥ 50,000 x 10^9/L or~A ≥ 100% increase in absolute neutrophil count (ANC) and an ANC of ≥ 0.5 x 10^9/L."|Week 12, 24, 36, 48 and 60|The intent-to-treat population included all patients who received at least 1 dose of study medication and had at least 1 follow-up assessment for safety and efficacy. N = the number of patients who had clinical response assessed during the time interval.||percentage of participants|||Number
135920|NCT00509899|Primary|Number of Participants With Adverse Events (AEs)|"Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline.~Treatment-Related AEs are those with a definite, probable, possible or missing causality.~A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above.~A severe or life-threatening AE is based on intensity, according to National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) v3.0."|From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.|Safety population included all patients who received at least 1 dose of study medication.||participants|||Number
148572|NCT00399542|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
135921|NCT00509873|Post-Hoc|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6|"Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."|6 Days|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Up to Day 6 analysis included all data up to the Day 6 time point but excluded any Day 6 visit data that was collected after the Day 6 time point)."||Percentage of Patients|||Number
135922|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6|Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
135923|NCT00509873|Secondary|Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6|Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
135924|NCT00509873|Secondary|Percentage of Patients With Microbiological Cure at Day 6|Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture)|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
135925|NCT00509873|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6|Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 6|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria. (Note: The Day 6 analysis included all Day 6 visit data, regardless of whether it was collected on Day 6 or on a later day)."||Percentage of Patients|||Number
135926|NCT00509795|Secondary|Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)|CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.|Baseline and at week 52|FAS population used for analysis.||mm^2||Standard Deviation|Mean
135927|NCT00509795|Secondary|Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 52|FAS population used for analysis.||scores on a scale||Standard Deviation|Mean
135928|NCT00509795|Secondary|Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.||percentage of patients|||Number
135929|NCT00509795|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at week 52|FAS population used for analysis.||letters read||Standard Deviation|Mean
135930|NCT00509795|Primary|Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)|Defined “maintenance of vision” as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.|Baseline and at week 52|PPS population used for analysis.||percentage of patients|||Number
135949|NCT00509366|Primary|1-year Progression Free Survival Rate in Chemo-naive Select Stage IIIB or Stage IV NSCLC Patients|One-year progression-free survival was defined from the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The one-year progression free survival rate is a percentage, representing the fraction of treated patients who, after one-year, are disease free or alive.|1 year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||percentage of treated patients||95% Confidence Interval|Number
135931|NCT00509769|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
135932|NCT00509769|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
135933|NCT00509769|Secondary|Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Percentage of patients||95% Confidence Interval|Number
135934|NCT00509769|Secondary|Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
135935|NCT00509769|Secondary|Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.|Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months)|Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Months||95% Confidence Interval|Median
135950|NCT00509288|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed listing of adverse events, see the adverse event module.|57 months|||Participants|||Number
136038|NCT00508651|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
135936|NCT00509769|Primary|Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months)|Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug.||Percentage of patients||95% Confidence Interval|Number
135937|NCT00509600|Primary|Patient Response|Response is defined as a WBC < 15,000 and platelets > 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.|12 weeks|No analysis as only registrant inevaluable, and trial terminated early due to poor enrollment.|||||
135938|NCT00509587|Secondary|Adverse Events Graded According to the NCI CTCAE Version 3.0|grade 3– 4 toxicities - transaminitis, hypertension, and neutropenia in three patients each (14% each) and grade 3 gastrointestinal hemorrhage in one patient (5%).|Up to 3 years|||percentage of patients|||Number
135939|NCT00509587|Secondary|Overall Survival|Computed using the Kaplan-Meier method.|Up to 3 years|||months||95% Confidence Interval|Median
135940|NCT00509587|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions|6 months|||percentage of patients||95% Confidence Interval|Number
135941|NCT00509587|Secondary|Duration of Stable Disease||From the start of the treatment until the criteria for progression are met, assessed up to 3 years|||months||95% Confidence Interval|Median
135942|NCT00509587|Secondary|Duration of Objective Response||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years||||||
135943|NCT00509587|Primary|Number of Participants With Partial and Complete Response.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT / MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years|||participant|||Number
135944|NCT00509496|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years|||Participants|||Number
135945|NCT00509496|Primary|Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|20 months|||Participants|||Number
135946|NCT00509366|Secondary|Drug Sensitivity Quartiles for Cisplatin and Pemetrexed|Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity.|3 years|This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates.|||||
135947|NCT00509366|Secondary|Mean Change From Baseline to Follow-up Cycle in Quality of Life - Functional Assessment of Cancer Therapy-Lung (FACT-L)|The outcome measure is mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L instrument consists of 34 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-being (FWB) and additional lung specific concerns (LCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and LCS scores (7 items), which each have a possible range between 0 and 28. Therefore, TOI ranges from 0 to 84.|Baseline, Every 21 days for a maximum of 6 cycles|Of the 50 patients assigned treatment, only 32 patients completed the FACT-L assessment at baseline and at least one follow-up.||units on a scale||Standard Error|Mean
135948|NCT00509366|Secondary|Median Time to Progressive Disease|Median time to progressive disease was defined as the time from enrollment to the the time at which 50% of patients had experienced disease progression. Enrollment is defined as having successful genomic analysis and start of chemotherapy. Time was censored at date of death for patients who have not had documented disease progression, at first available date of other anti-tumor therapy for patients who were either administered other anti-tumor therapy prior to documented disease progression or administered other anti-tumor therapy without documented disease progression, and at last date of followup if neither non-protocol therapy was administered nor progression documented.|1 Year|Due to the irreproducible nature of the genomic signatures of cisplatin sensitivity, analyses based on separate treatment groups were inappropriate. Therefore, all enrolled participants (initiated for treatment) from both treatment arms were analyzed together.||months||95% Confidence Interval|Number
135988|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)|Change in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization)|Baseline and 54 weeks|||Puffs per day||Standard Deviation|Mean
135951|NCT00509288|Primary|Clinical Tumor Regression.|Tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7/5/07-4/23/09|||Participants|||Number
135952|NCT00509262|Secondary|Change From Baseline in Body Weight at Week 54||Baseline to Week 54|All participants as treated (APaT) population included participants who had both baseline and Week 54 data (excluding data after initiation of glycemic rescue therapy).||kg||Standard Error|Least Squares Mean
135953|NCT00509262|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54||Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.||mg/dL||Standard Deviation|Mean
135954|NCT00509262|Primary|Percentage of Participants With Hypoglycemic Events|Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.|Baseline up to 28 days following the last dose of study therapy|All participants as treated (APaT) population included all randomized participants who took at least one dose of study therapy.||percentage of participants|||Number
135955|NCT00509262|Primary|Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54|A1C represents percentage of glycosylated hemoglobin.|Baseline to Week 54|The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.||Percent of glycosylated hemoglobin||Standard Deviation|Mean
135956|NCT00509249|Primary|Hematological Response Rate|Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.0x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still > 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR.|Up to 3 years|||participants|||Number
135957|NCT00509236|Secondary|Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment|Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.||Percent hemoglobin A1c||95% Confidence Interval|Least Squares Mean
135958|NCT00509236|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.||mg/dL||Standard Deviation|Mean
135959|NCT00509236|Primary|Number of Participants With Clinical Adverse Events|Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.|54 Week Treatment Period + 28 days|All randomized participants.||Participants|||Number
135960|NCT00509236|Secondary|Number of Participants With Symptomatic Hypoglycemic Adverse Events|A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.|54 Week Treatment Period + 28 days|All randomized participants.||Participants|||Number
135961|NCT00509236|Primary|Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment|Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.|Baseline / Week 54|Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values.||Percent hemoglobin A1c||Standard Deviation|Mean
135962|NCT00509223|Primary|HbA1c Change|Month 6 change in HbA1c (%)|Baseline to Month 6|The following definition was applied to the primary endpoint: included in analysis were all participants that had at least 1 follow-up HbA1c value in addition to the Baseline HbA1c were considered.||HbA1c percent||Standard Deviation|Mean
135963|NCT00509197|Secondary|Change in Provocative Concentration of Methacholine Inducing a 20% Fall in FEV1 (PC20)|Change in provocative concentration of methacholine inducing a 20% fall in FEV1 (PC20) after fluticasone or placebo treatment|Four weeks|||mg/ml||Standard Deviation|Mean
135964|NCT00509197|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|Change in forced expiratory volume in one second (FEV1) after fluticasone or placebo treatment.|Four weeks|||L||Standard Deviation|Mean
135965|NCT00509197|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score After 4 Weeks of Treatment|Validated questionnaire assessing quality of life related to asthma after 4 weeks of treatment. The AQLQ is composed of 32 questions in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The AQLQ score is rated on a 7-point scale (1=maximal impairment, 7=no impairment) to yield a mean score out of 7. The worse the quality of life is , the lower the score is.|Four weeks|||units on a scale||Standard Deviation|Mean
135989|NCT00509028|Secondary|Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)|Change in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization)|Baseline and 54 weeks|||Puffs per day||Standard Deviation|Mean
135966|NCT00509197|Primary|Asthma Control Questionnaire (ACQ) Score After 4 Weeks of Treatment With Inhaled Corticosteroids (ICS) or Placebo|Validated questionnaire assessing asthma control after 4 weeks of treatment with ICS or placebo. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of 7 items and thus ranges between 0 (well controlled) and 6 (extremely poorly controlled) to yield a mean score out of 6. The higher the score, the worst asthma control is.|Four weeks|Intention to treat||units on a scale||Standard Deviation|Mean
135967|NCT00509106|Secondary|Evaluate Safety||first dose, throughout the treatment period, and up to the TOC visit||||||
135968|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug||||||
135969|NCT00509106|Secondary|Microbiological Reinfection/Recurrence at LFU||21 to 35 days after last dose of study drug||||||
135970|NCT00509106|Secondary|Clinical Relapse at Late Follow Up (LFU) Visit||21-35 days after last dose of study drug||||||
135971|NCT00509106|Secondary|Clinical and Micriobiological Response by Pathogen at TOC||8-15 days after last dose of study drug||||||
135972|NCT00509106|Secondary|Overall Clinical and Radiographic Success Rate at TOC||8-15 days after last dose of study drug||||||
135973|NCT00509106|Secondary|Microbiological Success Rate at TOC||8-15 days after last dose of study drug||||||
135974|NCT00509106|Secondary|Clinical Response at End of Therapy (EOT)||Last day of study drug administration||||||
135975|NCT00509106|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population|"Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary~Failure: Any of the following:~Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy~Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia~Death wherein pneumonia (ie,CABP) was considered causative~Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug|The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.||participants|||Number
135976|NCT00509067|Secondary|Electrocardiogram||Measured at pre- and post-intervention||||||
135977|NCT00509067|Secondary|Nicotine Use||Measured at Baseline and Weeks 4, 8, 12, and 16||||||
135978|NCT00509067|Secondary|Cognitive Measures (MATRICS: Attention, Memory, Processing Speed)||Measured at Baseline and Weeks 8 and 16||||||
135979|NCT00509067|Secondary|Clinical Global Impression||Measured at Baseline and Weeks 4, 8, 12, and 16||||||
135980|NCT00509067|Primary|Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)|The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.|Measured at Baseline and Weeks 4, 8, 12, and 16|intent to treat||units on a scale||Standard Deviation|Mean
135981|NCT00509041|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 3 years)|||weeks||95% Confidence Interval|Median
135982|NCT00509041|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)|||weeks||95% Confidence Interval|Median
135983|NCT00509041|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 3 years)|||participants|||Number
135984|NCT00509041|Primary|24 Week Progression Free Survival|Percentage of participants who were alive and progression free at 24 weeks. The 24 week progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|24 weeks|||percentage of participants||95% Confidence Interval|Number
135985|NCT00509028|Secondary|Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline|Forced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 * (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1).|54 weeks|||Percentage||Standard Deviation|Mean
135986|NCT00509028|Secondary|Change From Baseline in Disturbance of Night-time Sleep|"Change in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization).~Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks|||Disturbances per night||Standard Deviation|Mean
135987|NCT00509028|Secondary|Change From Baseline in Disturbance of Daily Activities|"Change in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization).~Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable)."|Baseline and 54 weeks|||Disturbances per day||Standard Deviation|Mean
135990|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)|"Change in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization).~Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency."|Baseline and 54 weeks|||Points on a scale||Standard Deviation|Mean
135991|NCT00509028|Secondary|Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)|"Change in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4.~0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency"|Baseline and 54 weeks|||Points on a scale||Standard Deviation|Mean
135992|NCT00509028|Secondary|Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal|Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).|54 weeks|||Percentage||Standard Deviation|Mean
135993|NCT00509028|Secondary|Weight|Weight, change from baseline calculated as (weight at last visit - weight at randomization)|Baseline and 54 weeks|||kilograms||Standard Deviation|Mean
135994|NCT00509028|Secondary|Height|Height, change from baseline calculated as (height at last visit - height at randomization)|Baseline and 54 weeks|||Centimeters||Standard Deviation|Mean
135995|NCT00509028|Secondary|Number of Patients With Abnormal Plasma Cortisol Values.|Cut-off value of cortisol is defined as 4 mcg/dL.|54 weeks|||Participants|||Number
135996|NCT00509028|Secondary|Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator||54 weeks|||Participants|||Number
135997|NCT00509028|Secondary|Number of Patients With Abnormal Clinical Laboratory Test Values.|"Analysis of haematological, clinical chemistry and urynalysis variables were performed.~Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count.~Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen.~Urinalysis variables: protein, glucose, urobilinogen, occult."|54 weeks|||Participants|||Number
135998|NCT00509028|Primary|Number of Patients With Adverse Events (AEs).|AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.|54 weeks|||Participants|||Number
135999|NCT00508924|Primary|Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.|"Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30~Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay"|30 Days|||participants|||Number
136000|NCT00508924|Primary|Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.||5 - 10 min after initial bolus|||second||Inter-Quartile Range|Median
136001|NCT00508872|Primary|Complete Gross Resection Rate|Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).|Over 4 year study period|Intended analysis was per protocol. Study terminated early, leading to only two (2) patients recruited, one not eligible for study and second inevaluable.|||||
136002|NCT00508820|Secondary|Platelet Response (Definition 2)|Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants||Participants|||Number
136003|NCT00508820|Secondary|Platelet Response (Definition 1)|Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L|Duration of treatment (up to 201 weeks)|Full Analysis Set, all enrolled participants||Participants|||Number
136004|NCT00508820|Primary|Adverse Events|One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once|Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.|Safety Analysis Set, comprised of all participants who received at least one dose of romiplostim||participants|||Number
136005|NCT00508755|Primary|Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.|Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.|visit 48, following treatment|The sample size for this feasibility study was n=6, constrained by funding limit.||participants|||Number
136006|NCT00508742|Secondary|Percentage of Participants With Nasopharyngeal Cultures Testing Positive for 6A' (6A + 6C) or 19A Serotypes of Streptococcus Pneumoniae (S. Pneumoniae) at 7, 12, 13, 18 and 24 Months of Age||Month 7, 12, 13, 18, 24|Evaluable culture population; 'n' is number of participants with at least 1 determinate nasopharyngeal culture result for given serotype combination at specified time points for each arm group respectively.||percentage of participants||95% Confidence Interval|Number
136007|NCT00508742|Primary|Percentage of Participants With a New Acquisition of Serotype 6A' (6A + 6C) or 19A Combined 1 Month After the Infant Series to 24 Months of Age|A new acquisition was defined as the detection of a serotype (here 6A’ [6A + 6C] or 19A), once a participant was fully vaccinated (one month after dose 3), that had not been detected previously in the baseline samples at 2, 4, 6 months of age.|Month 7 through Month 24|Evaluable culture population included all participants who adhered to protocol requirements; received the treatment to which they were randomized; had at least 1 nasopharyngeal swab for the proposed analysis and no major protocol violations.||percentage of participants||95% Confidence Interval|Number
136008|NCT00508716|Primary|Re-hospitalization or Death|Number of participants who are re-hospitalized or die within 90 days of discharge|90 days|||participants|||Number
136021|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136009|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 3|Post-Dose 3 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
136010|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 2|Post-Dose 2 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
136011|NCT00508651|Secondary|Geometric Mean Titers of Serum Antibodies to HPIV3 Day 28 Post Dose 1|Post-Dose 1 GMT of HAI antibody to HPIV3|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
136012|NCT00508651|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to HPIV3 at Baseline|Pre-dose GMT of HAI antibody to HPIV3|Baseline (Day 0 prior to Dose 1)|Immunogenicity population was randomized participants who received investigational product, did not have a protocol violation that would affect interpretation of immunogenicity results, and had valid HAI results. HAI results obtained on/after detection of wild-type HPIV3 were not considered valid. A value of 2 was assigned for HAI titers < 4.||GMT||95% Confidence Interval|Mean
136013|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Phenotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Determination of the temperature sensitivity of recovered vaccine-type virus.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid phenotype data are available||samples containing vaccine-like virus|Participants||Number
136014|NCT00508651|Secondary|Number of Nasal Wash Samples Containing Vaccine-like Virus in the Absence of Admixture With Wild-type HPIV3 in Which the Vaccine-like Virus Was Genotypically Stable|A nasal wash specimen was collected at screening and on Days 7 (7-10), 12 (12-18), and 28 (28-34) post each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose to assess vaccine virus replication. Genotypic stability of recovered vaccine-type virus at the 15 mutations of phenotypic importance was assessed.|Day 0 after Dose 1 to 180 days after the final dose|All nasal wash samples in which MEDI-560 was identified in the absence of wild-type HPIV3 and for which valid genotype data are available||samples containing vaccine-like virus|Participants||Number
136015|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 3|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.||participants|||Number
136016|NCT00508651|Secondary|Number of Participants With HAI Seroconversion/Seroresponse to HPIV3 28 Days After Dose 2|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.||participants|||Number
136017|NCT00508651|Secondary|Number of Participants With Hemagglutination Inhibition (HAI) Seroconversion/Seroresponse to HPIV3 28 Days After Dose 1|Hemagglutination inhibition seroconversion/seroresponse is equal to or greater than a 4-fold rise in HAI antibody titer from baseline. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all randomized participants who received investigational product and who did not have a major protocol violation that would affect interpretation of immune response assay results and who had valid HAI results.||participants|||Number
136018|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3.|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136019|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136020|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136022|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136023|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136024|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136025|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136026|NCT00508651|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1||Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136027|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136028|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136029|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136030|NCT00508651|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were culture positive for HPIV3 in which vaccine-like virus was identified.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 180 days post final dose.|The shedding population included all randomized participants who received investigational product and for whom at least one shedding sample result was available.||participants|||Number
136031|NCT00508651|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after final dose|Safety population was randomized participants who received investigational product and had any safety follow-up, including a temperature measurement, SE, AE, concomitant medication use, or follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).||participants|||Number
136032|NCT00508651|Primary|Number of Participants With SAEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
136033|NCT00508651|Primary|Number of Participants With SAEs After Dose 2|One participant had event of pneumonia after Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
136034|NCT00508651|Primary|Number of Participants With Serious Adverse Events (SAEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for SAEs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
136035|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
136036|NCT00508651|Primary|Number of Participants With MA-LRIs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
136037|NCT00508651|Primary|Number of Participants With Medically Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for MA-LRIs included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participant|||Number
136119|NCT00507559|Secondary|Effectiveness: Thrombosis|Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure|5 years|Events classified by the clinical events committee as thrombosis in device, embolism, device occlusion, vascular occlusion and thrombosis were included in the number of patients affected||participants|||Number
136039|NCT00508651|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose)||participants|||Number
136040|NCT00508651|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for adverse events included randomized participants who received investigational product for the specified dose and had any safety follow-up after that dose (ie, did not discontinue on Day 0 after that dose).||participants|||Number
136041|NCT00508651|Primary|Number of Participants With SEs After Dose 3||Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.||participants|||Number
136042|NCT00508651|Primary|Number of Participants With SEs After Dose 2||Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
136043|NCT00508651|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1||Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
136044|NCT00508521|Primary|Fugl-Meyer Upper Limb Coordination Scale (FMUE)|A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.|baseline and after 12 weeks of training|||units on a scale||Standard Deviation|Mean
136045|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 12th week of follow-up|ITT analysis was used.||percentage of participants|||Number
136046|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||at the 4th week of follow-up|ITT analysis was used||percentage of participants|||Number
136047|NCT00508482|Secondary|Percentage of the Usage of Emergency Drugs||over 4 weeks of treatment|ITT analysis was used.||percentage of participants|||Number
136048|NCT00508482|Secondary|Time to the First Spontaneous Bowel Movement After the First Treatment||counting by hours|ITT analysis was used||hours||Standard Deviation|Mean
136049|NCT00508482|Secondary|Change of Mean Value of Cleveland Clinic Score|Cleveland Clinic Score was assessed by doctors which contains eight items about constipation-related symptoms. Score ranges from '0' to '30'. '0' means none of symptoms and '30' means very severe symptoms. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used||units on a scale||Inter-Quartile Range|Median
136050|NCT00508482|Secondary|Change of Mean Value of Abdominal Distention|Score of abdominal distention was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of abdominal distention over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of abdominal distention by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.||units on a scale||Standard Deviation|Mean
136051|NCT00508482|Secondary|Change of Mean Value of Stool Consistency|Score of stool consistency was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of stool consistency over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of stool consistency by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used.||units on a scale||Standard Deviation|Mean
136052|NCT00508482|Secondary|Change of Mean Value of Incomplete Evacuation|Score of incomplete evacuation was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of incomplete evacuation over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment.|over 4 weeks of treatment|ITT analysis was used.||units on a scale||Inter-Quartile Range|Median
136053|NCT00508482|Secondary|Change of Mean Value of Straining During Defecating|Score of straining during defecating was assessed every week according to patients' diaries during 4 weeks of treatment. Score ranges from '0' to '4'. '0' means none of symptoms and '4' means very severe symptoms. Change from baseline of the mean value of straining during defecating over 4 weeks of treatment was evaluated as the secondary outcome. The change was calculated as the value at baseline minus the average over 4 weeks of treatment. We corrected the mean value of straining during defecating by covariance because the data had significant difference among three groups at baseline.|over 4 weeks of treatment|ITT analysis was used||units on a scale||Standard Deviation|Mean
136054|NCT00508482|Primary|Change of Mean Weekly Spontaneous Bowel Movements|Spontaneous bowel movements per week were assessed every week during 4 weeks of treatment according to patients' diaries. Weekly spontaneous bowel movements were also assessed at the 4th and 12th week of follow-up according to patients' diaries.|over 4-week treatment, at the 4th week of follow-up, at the 12th week of follow-up|Intention-To-Treat(ITT) analysis was used.||stools/week||Inter-Quartile Range|Median
136055|NCT00508469|Primary|Adherence|Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.|6 months|Per protocol||percentage of adherent patients|||Number
136056|NCT00508404|Secondary|Resection Rate|The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
136057|NCT00508404|Secondary|Time to Disease Relapse Following Surgical Intervention|Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set participants who underwent surgery||months||95% Confidence Interval|Median
136058|NCT00508404|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
136059|NCT00508404|Secondary|Duration of Stable Disease|Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with a best response of SD||months||95% Confidence Interval|Median
136060|NCT00508404|Secondary|Time to Disease Progression|Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
136061|NCT00508404|Secondary|Progression-free Survival|Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods.|From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.|Primary Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, and had evaluable KRAS status data)||months||95% Confidence Interval|Median
136062|NCT00508404|Secondary|Time to Initial Objective Response|Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set||months||95% Confidence Interval|Median
136063|NCT00508404|Secondary|Duration of Response|Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method.|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.|KRAS Tumor Response Analysis Set with an objective response (CR or PR)||months||95% Confidence Interval|Median
136064|NCT00508404|Secondary|Disease Control Rate|"The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator.~Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
136065|NCT00508404|Secondary|Objective Response by 17 Weeks|The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.|Up to Week 17|KRAS Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
136075|NCT00508157|Secondary|Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16|IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
136120|NCT00507559|Secondary|Effectiveness: Type I Endoleak and Type III Endoleak|Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure|12 months|Denominator is the number of subjects with adequate CT imaging available at 12 months||participants|||Number
136066|NCT00508404|Primary|Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.~Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.~Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions."|Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks|KRAS Tumor Response Analysis Set (all participants who provided informed consent, enrolled, received at least 1 dose of panitumumab, had evaluable KRAS status data, and with at least 1 unidimensionally measurable lesion per modified RECIST by the local investigator)||percentage of participants||95% Confidence Interval|Number
136067|NCT00508391|Primary|Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device|The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device. These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.|60 days after enrollment|||Percent of Subjects|||Number
136068|NCT00508391|Primary|"Percentage of Subjects Classified as Not Worsened for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing"|"The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified not worsened if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105."|60 days after enrollment|Study utilized an intention-to-treat analysis. 111 out of 122 enrolled subjects completed the primary endpoint follow-up. 106 of these subjects met analysis criteria based on paired quality of life and six-minute walk data at the one and two month visits. Subjects not included in analysis either withdrew consent or had incomplete study measures.||Percent of Subjects|||Number
136069|NCT00508274|Secondary|Central Nervous System as First Site of Relapse|Number of participants who have Central Nervous System metastasis as the first site of relapse. CT, Magnetic Resonance Imaging, etc. were used for the assessment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product||participants|||Number
136070|NCT00508274|Secondary|Duration of Response|Duration of response is defined as the time of first documentation of disease response until the date of disease progression or death due to breast cancer, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product||Months||Full Range|Median
136071|NCT00508274|Secondary|Time to Response|Time to response is defined as the time from first dose date until first documentation of disease response.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at lease one dose of investigational product||Months||Full Range|Median
136072|NCT00508274|Secondary|Six Months Progression-Free Survival|Six Months Progression-Free Survival is defined as the percentage of surviving participants who are free of disease progression longer than six months (greather than 180 days) after the first start date of study treatment.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Mean
136073|NCT00508274|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose date until the date of disease progression or death due to any reason, whichever occurs first.|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||Months||Full Range|Median
136074|NCT00508274|Primary|Clinical Benefit Rate (CBR)|"CBR is defined by the percentage of participants achieving either a confirmed tumor reponse or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A partial response requires a decrease of 30% or more, Progression requires an increase of at least 20%, and Stable disease falls in between these two. All responses have a repeat assessment to confirm the response."|Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 11.07 months.|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product||Percentage of participants||95% Confidence Interval|Mean
136096|NCT00508027|Primary|Change in Hemoglobin Level|Change in plasma hemoglobin (Hb) level after treatment with simvastatin|Baseline, 21 days|||gm/dL||Standard Deviation|Mean
136097|NCT00508027|Primary|Change in Total Cholesterol Level|Change in serum total cholesterol level after treatment with simvastatin|Baseline, 21 days|||mg/dL||Standard Deviation|Mean
136098|NCT00508027|Other Pre-specified|Change in Plasma TF Levels|Change in plasma tissue factor (TF) levels after treatment with simvastatin|Baseline, 21 days|||pg/mL||Standard Deviation|Mean
136076|NCT00508157|Secondary|Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16|The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120.|Baseline, Week 4, Week 8,Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
136077|NCT00508157|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
136078|NCT00508157|Secondary|Median Change From Baseline in Body Mass Index (BMI) Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
136079|NCT00508157|Secondary|Mean Change From Baseline in Body Weight Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
136080|NCT00508157|Secondary|Mean Change From Baseline for Fasting Glucose Levels Through Week 16||Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
136081|NCT00508157|Secondary|Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16|Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.|Baseline, Week 4, Week 8, Week 12, Week 16|This measure was not analyzed because the study was terminated early and there were insufficient data to draw meaningful conclusions.|||||
136082|NCT00508157|Secondary|Number of Participants Remaining on Metabolic Syndrome at Week 16|Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.|Week 16|LOCF, Safety Sample For handling missing values, the metabolic syndrome is assumed to be ongoing unless there is enough data to support the resolution of the metabolic syndrome.||participants|||Number
136083|NCT00508157|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16|Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.|Baseline, Week 16|Last Observation Carried Forward (LOCF) data set, Non-HDL measurements obtained after start of a treatment with a lipid-lowering agent were excluded; last measurement prior was used for LOCF analyses. Baseline data was carried forward for LOCF analysis for subjects for whom no on-treatment measurements for fasting non-HDL cholesterol was available.||percent change||Standard Error|Mean
136084|NCT00508144|Primary|Objective Response Rate (OR) Where OR=CR+PR: Number of Participants With Responses of Complete Response (CR) and Partial Response (PR)|"Complete Response (CR): Complete disappearance of all measurable & non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers & other abnormal lab values.~Partial Response (PR): Applies only to those with at least one measurable lesion. >/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques as baseline.~Progression: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using same techniques as baseline. Unequivocal progression of non-measurable disease in opinion of treating physician.~Evaluated for symptoms 1-2 times per week while receiving treatment then 2 weeks after stopping study treatment (expected 4 cycles)."|Evaluated with 3 week treatment cycles, up to 4 cycles or 12 weeks|Of 58 eligible participants, only 54 treated were available for response and five (5) experienced an early death, five (5) were later deemed inevaluable, and two had an indeterminate response.||Participants|||Count of Participants
136085|NCT00508118|Secondary|Transcranial Doppler Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
136086|NCT00508118|Secondary|Cerebral Oximetry Measurements||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
136087|NCT00508118|Secondary|Bispectral Index Scores (BIS)||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
136088|NCT00508118|Secondary|Time Points for SSEP Latency and Amplitude Changes||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
136089|NCT00508118|Secondary|Time Points of EEG Patterns||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
136090|NCT00508118|Secondary|Temperature at Which Ablation of(SSEP)Occurs||Day of surgery through discharge|No participants were analyzed due to study terminated early.|||||
136091|NCT00508118|Secondary|Temperature at Which ECS Occurs||Day of surgery through discharge|No participants analyzed due to study terminated early.|||||
136092|NCT00508118|Primary|Duration From Initiation of Cardiopulmonary Bypass (CPB) to Electrocerebral Silence (ECS), Defined as no Discernable Electroencephalographic Activity at an Amplification of 2 Micro Volts (μV)/mm, Confirmed for 3 Minutes||Day of surgery|3 SUBJECTS PER PROTOCOL.||Time (minutes)||95% Confidence Interval|Median
136093|NCT00508027|Primary|Change in Serum Creatinine Levels|Change in serum creatinine (Cr) levels after treatment with simvastatin|Baseline, 21 days|||mg/dL||Standard Deviation|Mean
136094|NCT00508027|Primary|Change in Serum Alanine Transaminase (ALT) Levels|Change in serum alanine transaminase (ALT) after treatment with simvastatin|Baseline, 21 days|||U/L||Standard Deviation|Mean
136095|NCT00508027|Primary|Change in Serum Creatine Kinase Levels|Change in serum creatine kinase (CK) levels after treatment with simvastatin|Baseline, 21 days|||U/L||Standard Deviation|Mean
136103|NCT00508027|Other Pre-specified|Change in Plasma NOx Levels|Measurements of the levels of plasma nitric oxide metabolites (NOx), high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1), tissue factor (TF) and vascular endothelial growth factor (VEGF)were performed before and after simvastatin treatment. Changes in mean plasma biomarker levels were assessed for each dose level; however, dose level 3 results were not analyzed, as only 2 subjects were enrolled in this dose group.|Baseline, 21 days|All participants for whom plasma biomarker levels were recorded at baseline and 21 days||micromolar||Standard Deviation|Mean
136104|NCT00508001|Secondary|Overall Survival|Overall survival defined as the time from randomization (start of treatment) until death from any cause.|assessed up to 360 days|The analysis performed in the intent-To-Treat population.||Days||95% Confidence Interval|Median
136105|NCT00508001|Secondary|Progression-free Survival|Progression-free survival defined as the period from date of randomization(start of treatment) to date of disease progression or death.|from the date of randomisation to the date of documented disease progression or death for any cause|The analysis has been performed in the Intent-To-Treat (ITT) population.||Days||95% Confidence Interval|Mean
136106|NCT00508001|Secondary|Objective Response Rate|"Objective Response rate defined as percentage of patients with Complete Response [CR] or Partial Response [PR] based on Response Evaluation Criteria in Solid Tumours (RECIST).~Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions as assessed by Magnetic Resonance Imaging (MRI). Complete response (CR) must have disappearance of all target and non-target lesions as assessed by MRI."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.||percentage of patients|||Number
136107|NCT00508001|Primary|Tumour Stabilisation Rate|"Tumour stabilisation rate calculated as percentage of patients with best objective tumour response (Complete Response, Partial Response or Stable Disease) for >=16 weeks based on Response Evaluation Criteria in Solid Tumours (RECIST).~Complete Response - Disappearance of all target lesions; Partial Response - >=30% decrease in the sum of longest diameter of target lesions; Progressive Disease - >=20% increase in the sum of longest diameter of target lesions; Stable Disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|After 16 weeks of treatment.|The analysis has been performed in the Intent-To-Treat (ITT) population.||percentage of patients|||Number
136108|NCT00507819|Secondary|Change From Baseline in Mean Minute Ventilation (L/Min) at 6 Weeks|Minute ventilation measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||L/min||Standard Deviation|Mean
136109|NCT00507819|Secondary|Change From Baseline in Mean Respiratory Rate (Breaths/Min) at 6 Weeks|Respiratory rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||breaths/min||Standard Deviation|Mean
136110|NCT00507819|Secondary|Change From Baseline in Mean Heart Rate (Bpm) at 6 Weeks|Heart rate was measured at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||bpm||Standard Deviation|Mean
136111|NCT00507819|Primary|Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks|Oxygen consumption measurements were taken at peak exercise. Subjects were exercised to maximal volition with an electronically braked cycle ergometer. The protocol consisted of 3 minutes of pedaling in an unloaded state followed by a ramp increase in work rate (watts) to maximal exercise. Metabolic and ventilatory data were obtained throughout the exercise study and for the first 2 minutes of recovery on a breath-by-breath basis with a metabolic cart.|Baseline and 6 Weeks|||mL/kg/min||Standard Deviation|Mean
136112|NCT00507767|Primary|Number of Participants With Progression-free Survival at 12-weeks|Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.|At 12-weeks|Analysis per protocol.||participants|||Number
136113|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 96|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.||percentage of participants|||Number
136114|NCT00507689|Secondary|Percentage of Participants With Normal ALT at Week 72|Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.|Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.||percentage of participants|||Number
136115|NCT00507689|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96||Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.||percentage of participants|||Number
136116|NCT00507689|Secondary|Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72||Week 72|Participants in the Full Analysis Set with available data at Week 72 were analyzed.||percentage of participants|||Number
136117|NCT00507689|Secondary|Percentage of Participants With HBV Recurrence at Week 96|HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.|Week 96|Participants in the Full Analysis Set with available data at Week 96 were analyzed.||percentage of participants|||Number
136118|NCT00507689|Primary|Percentage of Participants With HBV Recurrence Prior to or at Week 72|HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.|Pretreatment baseline through Week 72|Full Analysis Set||percentage of participants|||Number
136123|NCT00507559|Secondary|Effectiveness: Aneurysm Change|Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure|12 months|Denominator is number of subjects with assessable imaging. Films are not assessable for aneurysm change if the 30-day scan is not available as a baseline.||participants|||Number
136124|NCT00507559|Secondary|Effectiveness: Aneurysm Rupture|Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure|12 months|143 reflects the number of subjects with data for the 12 month visit.||participants|||Number
136125|NCT00507559|Secondary|Effectiveness: Surgical Conversion|"Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure.~Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device."|12 months|143 reflects the number of subjects with data for the 12 month visit.||participants|||Number
136126|NCT00507559|Secondary|Safety: SAE (Serious Adverse Event)|Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure|5 years|||participants|||Number
136127|NCT00507559|Primary|Safety: MAE (Major Adverse Event)|Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group|30 days|||participants|||Number
136128|NCT00507559|Primary|Effectiveness: Composite Success Rate|Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%.|12 months|||participants|||Number
136129|NCT00507546|Secondary|Change in Subjective Morning Alertness|Measured as the median of the average morning alertness (measured from 1-7 on the Stanford Sleepiness Scale, a Likert-like scale in which higher values are lower alertness) of the three weeks of either placebo or ramelteon treatment|10 weeks|||units on a scale||Full Range|Median
136130|NCT00507546|Primary|Amount of Wakefulness After Sleep Onset (WASO)|Measured as the median of the average WASO of the three weeks of either placebo or ramelteon treatment|10 weeks|All participants who completed the entire protocol.||Minutes||Full Range|Median
136131|NCT00507507|Secondary|Occurrence of HBV Resistance Mutations|The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192).|Baseline to Week 192|Genotyping was attempted for all participants with HBV DNA ≥ 400 copies/mL at Week 48, 96, 144, 192 and/or the early discontinuation visit, and for all participants (with HBV DNA ≥ 400 copies/mL) after Week 192 who were on study for at least 216 weeks when the last participant reached Week 192.||participants|||Number
136132|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192|The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Weeks 48, 96, 144, and 192|Full Analysis Set||participants|||Number
136133|NCT00507507|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192|The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Weeks 48, 96, 144, and 192|Full Analysis Set||participants|||Number
136134|NCT00507507|Secondary|Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192|"The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.||participants|||Number
136135|NCT00507507|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192|"The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point."|Weeks 48, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.||participants|||Number
136136|NCT00507507|Secondary|Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192|Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set||participants|||Number
136137|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 192|The change from baseline in HBV DNA at Week 192 was analyzed.|Baseline to Week 192|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
136138|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 144|The change from baseline in HBV DNA at Week 144 was analyzed.|Baseline to Week 144|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
136139|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 96|The change from baseline in HBV DNA at Week 96 was analyzed.|Baseline to Week 96|Participants in the Full Analysis Set with evaluable change data at Week 96 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
136140|NCT00507507|Secondary|Change From Baseline in HBV DNA at Week 48|The change from baseline in HBV DNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the Full Analysis Set with evaluable change data at Week 48 were analyzed.||log_10 copies/mL||Standard Deviation|Mean
136141|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192|The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, 144, and 192|Full Analysis Set||percentage of participants|||Number
136142|NCT00507507|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144|The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Weeks 48, 96, and 144|Full Analysis Set||percentage of participants|||Number
136143|NCT00507507|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192|The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.|Week 192|Full Analysis Set: participants who were randomized and received at least one dose of study drug||percentage of participants|||Number
136144|NCT00507455|Secondary|Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
136145|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions regarding daily activities affected by urinary problems. Participants responded to each question on a scale from 1 (not at all) to 4 (a lot). The total symptom score ranges from 19 to 76, where larger scores correspond to a lesser quality of life).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
136146|NCT00507455|Secondary|Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MLUTS questionnaire which consists of 13 symptom bother questions. Each question is answered by the participant on a scale from 0 (not at all) to 10 (a great deal). The total bother score ranges from 0 to 130, where larger scores correspond to worse outcomes.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
136147|NCT00507455|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MLUTS questionnaire which consists of 13 questions regarding urinary symptoms. Each question is answered by the participant on a scale from 0 (never) to 4 (all the time). The total symptom score ranges from 0 to 52, where larger scores correspond to worse conditions.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 4, 8 and 12|"Full analysis set (FAS) population with available data at Baseline and at each time point (indicated as N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||units on a scale||Standard Error|Least Squares Mean
136148|NCT00507455|Secondary|Change From Baseline in Volume Voided Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||mL||Standard Error|Least Squares Mean
136149|NCT00507455|Secondary|Change From Baseline in Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population who had 3-day averaged incontinence episodes >0 at Baseline and with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||incontinence episodes||Standard Error|Least Squares Mean
136150|NCT00507455|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours|"For each micturition and/or incontinence episode participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild urgency, could postpone passing water for as long as necessary; 2: Moderate urgency, could postpone passing water for a short while; 3: Severe urgency, could not postpone passing water; 4: Urge incontinence, leaked before reaching the toilet. An urgency episode is defined as an episode with urgency severity of three or higher.~The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||urgency episodes||Standard Error|Least Squares Mean
136151|NCT00507455|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||micturitions||Standard Error|Least Squares Mean
136189|NCT00503984|Secondary|Duration of Response|Length of time from the date of first observation of complete response (CR) or partial response (PR) to the date of first observation of disease progression, according to prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|The 10 participants in both Phase 1 and Phase 2 who achieved PSA response.||weeks||Full Range|Median
136152|NCT00507455|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) questionnaire asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
136153|NCT00507455|Secondary|Change From Baseline in IPSS Storage Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
136154|NCT00507455|Secondary|Change From Baseline in IPSS Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
136155|NCT00507455|Secondary|Change From Baseline in International Prostate Symptoms Score (IPSS)|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms:~Sensation of incomplete emptying~Repeat urinating after 2 hours (frequency)~Start and stop several times (intermittency)~Urgency~Weak stream~Straining~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|Full analysis set (FAS) population with available data at each time point. End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method.||units on a scale||Standard Error|Least Squares Mean
136156|NCT00507455|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|Safety analysis set population consisted of participants who received at least 1 dose of double-blind treatment.||participants|||Number
136157|NCT00507455|Secondary|Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)|"Percent Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency.~LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.||Percent voiding efficiency||Standard Error|Least Squares Mean
136158|NCT00507455|Secondary|Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)|"The Bladder Contractility Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~LS means were adjusted for pooled center and Baseline value."|Baseline and Week 12|Full analysis set (FAS) population; Last observation carried forward (LOCF) imputation was used.||units on a scale||Standard Error|Least Squares Mean
136159|NCT00507455|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had urodynamic measurements at baseline and post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.||mL/sec||Standard Error|Least Squares Mean
136160|NCT00507455|Secondary|Change From Baseline in Post Void Residual Volume (PVR)|"Healthy micturitions result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding (post-void residual urine). Post void residual volume was assessed by abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~End-of-treatment is the last post-baseline assessment during the treatment period.~Least squares (LS) means were adjusted for pooled center and the Baseline value."|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set (FAS) population with available data at each time point (as indicated by N). End of treatment includes participants who did not complete the Week 12 visit using the last observation carried forward method."||mL||Standard Error|Least Squares Mean
136252|NCT00506441|Secondary|Change From Baseline in Triglyceride||12 weeks||||||
136253|NCT00506441|Secondary|Change From Baseline in VLDL Cholesterol||12 weeks||||||
136161|NCT00507455|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.|Baseline and Week 12|Full analysis set (FAS) population consisted of participants who received at least one dose of double-blind treatment and had both urodynamic measurements at baseline and one or both measured at any post-baseline on-treatment visit. Last observation carried forward (LOCF) imputation was used.||cmH2O||Standard Error|Least Squares Mean
136162|NCT00507442|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death|Up to 48 weeks or until death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||days||95% Confidence Interval|Median
136163|NCT00507442|Secondary|Probability of 1-year Survival||survival probability at 1 year after randomization|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||percentage of patients|||Number
136164|NCT00507442|Secondary|Progression-free Survival|"Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression/death|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||days||95% Confidence Interval|Median
136165|NCT00507442|Secondary|Time to Response|Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments.|Up to 48 weeks or until disease response|Responders (patients achieved complete and partial response) in the response evaluable population.||days||Full Range|Median
136166|NCT00507442|Secondary|Time to Disease Progression|"Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.||days||95% Confidence Interval|Median
136167|NCT00507442|Secondary|Duration of Response|"Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments.~Disease progression requires any one or more of the following: serum m-protein increase >= 25% from nadir(absolute increase >= 0.5 g/dL); Urine m-protein increase >= 25% from nadir(absolute increase >= 200 mg/24 hr), bone marrow plasma cell percentage increase >= 25% from nadir(absolute increase >= 10%), new bone lesion or soft tissue plasmacytomas."|Up to 48 weeks or until disease progression|Responders (patients achieved complete and partial response) in the response evaluable population.||days||95% Confidence Interval|Median
136168|NCT00507442|Secondary|Number of Patients With Complete Response Rate + Near Complete Response Rate|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
136169|NCT00507442|Secondary|Number of Patients With Stringent Complete Response Rate|Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
136170|NCT00507442|Secondary|Number of Patients With Overall Response|"Overall Response includes complete response and partial response.~Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to < 200 mg per 24 hour."|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
136171|NCT00507442|Secondary|Number of Patients With Adverse Events (AEs)|Evaluate the safety and tolerability of the combination therapy|From first dose of study drug through the 30 day post-treatment AE assessment visit|The safety population includes patients received any dose of any study drug.||participants|||Number
136172|NCT00507442|Primary|Number of Patients With Combined Complete Response and Very Good Partial Response|"Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.~Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h"|Up to 48 weeks or until disease progression|The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.||participants|||Number
136173|NCT00507429|Secondary|To Determine Percentage of 1 Year Survival||from randomization through end of study visit|Intent to treat||percentage of participants|||Number
136174|NCT00507429|Secondary|To Determine Progression Free Survival||from randomization through end of study visit||||||
136175|NCT00507429|Primary|Overall Survival||From randomization to date last known alive|All randomized subjects (the Intent-to-treat population) included in the analysis||months||95% Confidence Interval|Median
136176|NCT00507416|Secondary|Change From Baseline in EORTC QLQ-C30 - Global Health Status|"The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement."|Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13|"Intent-to-treat population with available data at each time point (indicated by n)."||units on a scale||Standard Deviation|Mean
136177|NCT00507416|Secondary|Time to Alternative Therapy|Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact.|From randomization until alternative therapy. Median follow-up time was 43 months.|Intent to Treat||months||95% Confidence Interval|Median
136178|NCT00507416|Secondary|Overall Survival|Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.|From randomization until death. Median follow-up time was 43 months.|Intent to treat||months||95% Confidence Interval|Median
136179|NCT00507416|Secondary|Duration of Response|Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response.|From first documented response until disease progression. Median follow-up time was 43 months.|Participants with an overall response||months||95% Confidence Interval|Median
136180|NCT00507416|Secondary|Percentage of Participants With a Complete Response or a Very Good Partial Response|"Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.~Response was assessed by the Investigator using the IMWG uniform response criteria."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.||percentage of participants|||Number
136181|NCT00507416|Secondary|Percentage of Participants With a Complete Response|Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria.|Response assessed every other cycle, for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.||percentage of participants|||Number
136182|NCT00507416|Secondary|Percentage of Participants With an Overall Response|"Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.~CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).~PR requires 1 of the following:~≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or~If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or~If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.~If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."|Response assessed every other cycle for up to 13 cycles (49 weeks).|Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.||percentage of participants|||Number
136183|NCT00507416|Primary|Progression Free Survival (PFS)|"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease"|From randomization until disease progression. Median follow-up time was 43 months.|Intent-to-treat (all randomized participants)||months||95% Confidence Interval|Median
136184|NCT00507208|Primary|Number of Participants Demonstrating Improved MIO Using Either the Dynapslint System or Tongue Depressors|Number of participants who demonstrated improved maximal incisial opening (MIO), the distance from the tips of the upper and lower incisors on maximal effort. Successful improvement is defined as > 5mm improvement from the baseline measurement.|12 months|||participants|||Number
136185|NCT00503997|Primary|Patient Response to Treatment Measured by RECIST Criteria|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 8 weeks|||participants|||Number
136186|NCT00503984|Secondary|Number of Participants Experiencing Adverse Events After Beginning Protocol Therapy.||Up to 4.5 years|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.||participants|||Number
136190|NCT00503984|Primary|Number of Participants Achieving Complete Response (CR) or Partial Response (CR) to Protocol Therapy.|"Number of participants achieving Complete Response (CR) or Partial Response to protocol therapy according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 Criteria. Per RECIST 1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; "|Up to 4.5 years|Number of evaluable participants with measurable disease on CT scan. Only 10 of the 19 evaluable participants had measurable disease on CT Scan.||participants|||Number
136191|NCT00503984|Primary|Number of Participants Achieving Prostate-specific Antigen (PSA) Response.|Number of participants achieving prostate-specific antigen (PSA) response according to Prostate Cancer Working Group 1 (PCWG1) criteria. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.|Up to 4.5 years.|Of the 22 participants enrolled, only 19 were evaluable because they completed 2 or more cycles of protocol therapy.||participants|||Number
136192|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Prednisone)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.||mg|||Number
136193|NCT00503984|Primary|Phase I - Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel in Combination With Prednisone. (Azacitidine and Docetaxel)|Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.|Up to 1.5 years|Number of participants enrolled in the Phase 1 portion of the study. The initial RPTD was 150 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone. However, due to the death of one patient, the Data and Safety Monitoring Board (DSMB) recommended that the RPTD be reduced to 75 mg/m2 Azacitidine + 75 mg/m2 Docetaxel, with 5mg of Prednisone.||mg/m2|||Number
136194|NCT00503906|Secondary|To Determine Safety and Side Effect Profile of the Treatment Combination.|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Over the course of study treatment.||||||
136195|NCT00503906|Secondary|Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment||Baseline, over the course of Treatment||||||
136196|NCT00503906|Secondary|Percentage of Subjects Achieving 24 Months Survival|Percentage of subjects achieving 24 month survival, the time from date of initial Gemcitabine, Abraxane and Bevacizumab therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up12 month survival|24 months|||percentage of participants||95% Confidence Interval|Number
136197|NCT00503906|Secondary|Percentage of Subjects Achieving 18 Month Survival|Percentage of subjects achieving 18 month survival, the time from date of initial Gemcitabine, Abraxane and Bevacizumab therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up|18 months|||percentage of participants||95% Confidence Interval|Number
136198|NCT00503906|Secondary|Percentage of Subjects Achieving 12 Month Survival|Percentage of subjects achieving 12 month survival,the time from date of initial Gemcitabine, Abraxane and Bevacizumab therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up12 month survival|12 months|||percentage of participants||95% Confidence Interval|Number
136199|NCT00503906|Secondary|Percentage of Subjects Achieving 6 Month Survival|The percentage of subjects achieving 6 month survival, the time from date of initial Gemcitabine, Abraxane and Bevacizumab therapy to date of death. In the absence of confirmation of death, survival time will be censored to last date of follow-up|6 months|||percentage of particpants||95% Confidence Interval|Number
136200|NCT00503906|Primary|Progression-free Survival|Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.|6 months|||percentage of particpants||95% Confidence Interval|Number
136201|NCT00507130|Secondary|Terminal Phase Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis||Day||Standard Deviation|Mean
136202|NCT00507130|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis||Micrograms per milliliter||Standard Deviation|Mean
136203|NCT00507130|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 3, 7, 10, 14, 17, 21, 24, 26, 28, 31, 35, 42, 49, 56, 70, 84, 119, and 150|All subjects who received at least one dose of MEDI-528 and had blood samples analyzed for pharmacokinetic analysis||Day||Standard Deviation|Mean
136204|NCT00507130|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, 119, and 150|All subjects who received at least one dose of MEDI-528||Participants|||Number
136205|NCT00507130|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
136206|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results|Number of participants experiencing abnormal clinically significant MRI results|Days -14 to -1 and 28|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
136207|NCT00507130|Primary|Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results|Number of participants with abnormal clinically significant ECG results|Days -14 to -1, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
136254|NCT00506441|Secondary|Change From Baseline in HDL Cholesterol||12 weeks||||||
136255|NCT00506441|Secondary|Change From Baseline in LDL Cholesterol||12 weeks||||||
136208|NCT00507130|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 14, 28, 56, 84, and 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
136209|NCT00507130|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 150|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
136210|NCT00506948|Primary|Number of Participants With Acute Graft-versus-host Disease (aGVHD)|Participants who had acute graft-versus-host disease (aGVHD) within 100 days post transplant. Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant|||participants|||Number
136211|NCT00506948|Primary|Failure Rate|Efficacy failure defined as a participants who had either grade 3-4 acute graft-versus-host disease (aGVHD) or treatment related mortality (TRM) within 100 days post transplant. Failure Rate calculated as (# of failures) / (# participants evaluated). Physical exam and bloodwork every week (for the first 90-100 days after the transplant).|Baseline to 100 days post transplant||||||
136212|NCT00506922|Primary|Number of Patients Without GVHD at 100 Days|The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days.|100 days|All analysis was intention to treat (ITT).||participants|||Number
136213|NCT00506883|Primary|Responders|Responders were defined as patients who achieved a ≥ 50% reduction in target joint pain score from baseline at 24 hours without using rescue drug, using an 11 point scale from 0 to 10, with 10 being the worst pain imaginable after beginning therapy.|24 hours after baseline|The Intent-to-Treat (ITT) population(N=184) was used. The ITT group is defined as all patients who were randomized,and had a qualifying gout flare based on contact with the Gout Flare Call Center, who were instructed to begin taking and took at least one dose of the study drug study drug. One patient had a flare, but||Participants|||Number
136214|NCT00506857|Secondary|Number of Participants With Graft Versus Host Disease (GVHD)|Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status.|5 years|Analysis was per protocol for 73 patients out of 80 patients due to 3 early deaths and 4 non engraftments.||Participants|||Number
136215|NCT00506857|Primary|Maximum Tolerated Dose (MTD)|"Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where toxicity is defined as grade 3 or 4 conventional toxicity [National Cancer Institute Common Toxicity Criteria (NCI-CTC)]. Participant evaluation in a cohort with each modality is 30 days."|1 month|Analysis was per protocol.||mg/kg|||Number
136216|NCT00506831|Secondary|Change in Serum Autoantibody Profile at 6 Months Compared to Baseline||6 months compared to baseline||||||
136217|NCT00506831|Secondary|Change in High Throughput Gene Expression Analysis at 6 Months Compared to Baseline||6 months compared to baseline||||||
136218|NCT00506831|Secondary|Change in Serum Cytokine Profile at 6 Months Compared to Baseline||6 months compared to baseline||||||
136219|NCT00506831|Secondary|Change in Dermal Thickness and Collagen Separation on Cutaneous Histopathology at 6 Months Compared to Baseline||6 months compared to baseline||||||
136220|NCT00506831|Secondary|Change in Scleroderma Health Assessment Questionnaire at 6 Months Compared to Baseline||6 months compared to baseline||||||
136221|NCT00506831|Secondary|Change in Digital Ulcerations at 6 Months Compared to Baseline||6 months compared to baseline||||||
136222|NCT00506831|Secondary|Change in Pulmonary Function Tests at 6 Months Compared to Baseline||6 months compared to baseline||||||
136223|NCT00506831|Primary|Percent Change in Modified Rodnan Skin Score at 6 Months Compared to Baseline|Modified Rodnan skin score (mRSS) on scale of 0 (no skin disease) to 51 severe skin disease. %change in mRSS=(score at 6 months - baseline score)/baseline score. Negative values indicate improvement in skin disease. Clinical important improvement defined as > 25% improvement.|6 months compared to baseline|||percentage of change in MRSS||Standard Deviation|Mean
136224|NCT00506714|Secondary|Gait Velocity|Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use|4 weeks|Analysis was per protocol||cm/s||Standard Deviation|Mean
136225|NCT00506714|Secondary|Gait Velocity With a Cane in Hip OA Subjects|Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.|Baseline|Analysis was per protocol||cm/s||Standard Deviation|Mean
136226|NCT00506714|Primary|Gait Velocity||Baseline|Analysis was per protocol||cm/s||Standard Deviation|Mean
136227|NCT00506675|Primary|Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks|||logMAR||Standard Deviation|Mean
136228|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks|Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.|baseline to 10 Weeks|||Participants|||Number
136229|NCT00506675|Primary|Mean (SD) Distribution of Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks|||logMAR||Standard Deviation|Mean
136256|NCT00506441|Secondary|Change From Baseline in Total Cholesterol||12 weeks||||||
136257|NCT00506441|Secondary|Change From Baseline in Calcium x Phosphorus Ion Product||12 weeks||||||
136258|NCT00506441|Secondary|Change From Baseline in Calcium||12 weeks||||||
136259|NCT00506441|Secondary|Change From Baseline in PTH||12 weeks||||||
136230|NCT00506675|Primary|Distribution of Amblyopic Eye Visual Acuity at 10 Weeks|Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).|10 Weeks|||participants|||Number
136231|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 5-7|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 5-7|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.||episodes per week by visit||Standard Deviation|Mean
136232|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Months 2-4|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, months 2-4|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.||episodes per week by visit||Standard Deviation|Mean
136233|NCT00506662|Secondary|Mean Number of Total Hypoglycaemic Episodes, Month 1|Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.|weeks -2-0, month 1|The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.||episodes per week by visit||Standard Deviation|Mean
136234|NCT00506662|Secondary|Change in Body Weight at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136235|NCT00506662|Secondary|Change in Body Weight at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136236|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136237|NCT00506662|Secondary|Change in Mean Pre-dinner Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136238|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136239|NCT00506662|Secondary|Change in Mean Pre-lunch Plasma Glucose at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136240|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136241|NCT00506662|Secondary|Change in Mean Fasting Plasma Glucose (FPG) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136242|NCT00506662|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Month 4||week 0, month 4|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136243|NCT00506662|Primary|Change in Glycosylated Haemoglobin (HbA1c) at Month 7||week 0, month 7|Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.|||||
136244|NCT00506597|Primary|Number of Participants Treated With Erwinase as a Replacement for E.Coli L-asparaginase or Pegylated E.Coli L-asparaginase as Part of the Treatment for Acute Lymphoblastic Leukemia (ALL) or T or B Cell Lymphoma|Main objective of protocol Erwinase® Master Treatment Protocol (EMTP) was to enable United States (US) participants who were treated for Acute Lymphoblastic Leukemia (ALL) and who were allergic to Escherichia coli derived L-Asparaginase, whatever the formulation, to be treated with Erwinia derived L-Asparaginase (Erwinase®), under Investigational New Drug (IND) 290.|4 years|||participants|||Number
136245|NCT00506597|Primary|Participant Toxicity Data|Toxicity data collected and reported as adverse events during the study period. See Adverse Event section for reporting.|3 Years||||||
136246|NCT00506493|Secondary|Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|9 months|||percentage of subjects|||Number
136247|NCT00506493|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months||9 months|||percentage of subjects|||Number
136248|NCT00506493|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge|||percentage of subjects|||Number
136249|NCT00506493|Primary|Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months|Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours|9 months|75 subjects were enrolled, 14 subjects had no Holter assessment performed- 6 subjects died, 5 subjects withdrew participation, and 3 subjects completed endpoint follow-up without analyzable Holter data.||percentage of subjects|||Number
136250|NCT00506454|Primary|Reduction in Endotoxin Levels.|The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.|Baseline and at 4 weeks|||Participants|||Number
136251|NCT00506441|Secondary|Incidence of Adverse Events||12 weeks (Week 0-12) and 4 weeks (Week 12-16)||||||
136260|NCT00506441|Secondary|Change From Baseline in Serum Phosphorus||12 weeks (Week 0 to Week 12)|ITT1 (The ITT1 population included all enrolled subjects who have taken at least one dose of study medication and have at least one central phosphorus value after the start of study medication.)||mg/dL||95% Confidence Interval|Mean
136261|NCT00506441|Primary|The Change in Serum Phosphorus From Week 12 to Week 16|The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)|4 weeks (Week 12 to Week 16)|Intent-to-treat (ITT) 2 (The ITT2 population included all subjects who complete 12-weeks, receive a randomization number and receive at least one dose of study medication in the placebo-controlled withdrawal phase, either MCI-196 or placebo, and have at least one central phosphorus value after 12-weeks.)||mg / dL||Standard Deviation|Mean
136262|NCT00506415|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events||30 days after a maximum of 96 weeks treatment|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.||Participants|||Number
136263|NCT00506415|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI)-10 Score at Week 48 of Double Blind Period|Change from baseline to week 48 as assessed by the Neuropsychiatric Inventory (NPI)-10 total score. The scale consists of 10 domains that are rated for both frequency (range 1-4) and severity (range 1-3). A composite score for each domain is calculated (frequency x severity) which ranges from 1 to 12. There is a leading question for each item. If the symptom is not present then the frequency, severity and distress scores are not completed. In this case the score is 0 for the item. The sum of the composite scores yields the NPI-10 total score (range 0-120). A negative change in score indicates an improvement from baseline (symptom reduction).|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients with an assessment at baseline and week 48, who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).||units on a scale||Standard Deviation|Mean
136264|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part B) at Week 48 of Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part B. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. TMT has two parts: Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for TMT-Part B except the person must alternate between numbers and letters. Total values for TMT part B range between 0 and 420 seconds. A negative change from baseline indicates an improvement in condition.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog, ADCS-IADL).||Time in seconds||Standard Deviation|Mean
136265|NCT00506415|Secondary|Change in Attention and Executive Function as Assessed by the Trail Making Test (Part A) at Week 48 of the Double Blind Period|Change from baseline to week 48 in total time to perform Trail Making Test (TMT) part A. This test provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. The TMT part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. The score represents the amount of time required to complete the task. Total values for TMT part A range between 0 and 300 seconds. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population (ITT-DB): included all randomized patients with an assessment at baseline and week 48 who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables (ADAS-cog and ADCS-IADL).||Time in seconds||Standard Deviation|Mean
136266|NCT00506415|Secondary|Time to Functional Decline as Measured by Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale During the Double Blind Period|Functional decline was defined by either an at least 1 point decrease in the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) subscale score in a visit and confirmed by the following visit/assessment or at least 2 points decrease from the double blind randomization baseline.|390 days was the maximum|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.||Time in days||95% Confidence Interval|Median
136267|NCT00506415|Primary|Change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) Subscale Score From Baseline to Week 48 of Double Blind Period|The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.||units on a scale||Standard Deviation|Mean
136268|NCT00506415|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) Subscale at Week 48 of Double Blind Period|The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.|Baseline and week 48 of double blind period|Intent to treat population double blind (ITT-DB): included all randomized patients who received at least 1 dose of double blind study drug, and had at least 1 post-randomization assessment for both co-primary efficacy variables: Alzheimer's Disease Assessment Scale-Cognitive and Disease Cooperative Study-Instrumental Activities of Daily Living.||units on a scale||Standard Deviation|Mean
136345|NCT00504660|Primary|6 Month Progression-free Survival for Participants With Glioblastoma|Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression.|6 months|||percentage of participants|||Number
136269|NCT00506389|Secondary|Average Subjective Total Sleep Time (TST) During the In-Treatment Period|TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.||Minutes||Standard Deviation|Mean
136270|NCT00506389|Secondary|Average Latency to Persistent Sleep (LPS) During the In-Treatment Period|LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The ITT group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.||Minutes||Standard Deviation|Mean
136271|NCT00506389|Primary|Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period|WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.|From Day 1 to Day 36|The Intent-to-Treat (ITT) group consisted of all participants who were randomized, received at least one dose of double-blind trial medication, and had at least one post-randomization efficacy assessment. Fifteen participants from 1 site were excluded from all efficacy analyses.||Minutes||Standard Deviation|Mean
136272|NCT00506285|Secondary|Conners' Adult ADHD Rating Scales (CAARS)|Measures the DSM based ADHD criteria of Inattention and Hyperactivity/Impulsivity. There are 30 items scored 0-3 for a minimum score of 0 (no symptoms) and a maximum score of 90 worst possible symptoms.|Double-blind endpoints for MTS and placebo arms|||units on a scale||Standard Deviation|Mean
136273|NCT00506285|Primary|Wender Reimherr Adult Attention Deficit Disorder Scale|This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.|Double-blind endpoints during MTS and placebo arms|"All subjects given active treatment last observation carried forward using a mixed models design."||units on a scale||Standard Deviation|Mean
136274|NCT00506155|Secondary|5-year Overall Survival (OS)|The overall survival rate stated as a five-year survival rate, which is the percentage of participants in study who are alive five years after the start of treatment.|5 years|||Percentage of Participants|||Number
136275|NCT00506155|Primary|Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen|"Number of participants out of total with a response defined as “downstaging” to <= pT1N0 in the resected specimen. A binary variable was defined for downstaging (pathologic stage below initial clinical stage and below pT1N1N0M0); staging using American Joint Committee on Cancer (AJCC) TNM system of TNM; T describes size tumor & cancer spread into nearby tissue; N describes spread to nearby lymph nodes; & M describes metastasis (spread to other parts of body). Numbers after T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures, higher the T number, the larger the tumor and/or more it has grown into nearby tissues. Responses of lesser magnitude scored as treatment failure. Response Evaluation Criteria In Solid Tumors (RECIST) criteria do not apply for this cohort of neoadjuvant participants since this study does not require measurable disease by traditional assessment."|Following 20 weeks of chemotherapy|All 60 participants completed at least 1 cycle of chemotherapy.||Percentage of Participants|||Number
136276|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Working Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
136277|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Episodic Memory Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
136278|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Attention/Processing Speed Composite Score|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
136279|NCT00506077|Other Pre-specified|Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|"Pre-randomization baseline values for all treatment sequences are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148)."|Pre-randomization Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||Standard Error|Least Squares Mean
136365|NCT00504257|Secondary|Overall Survival (OS)|Overall Survival (OS): defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact (regardless of whether or not this contact is on a subsequent protocol). Survival (PFS and OS) were analyzed using the Kaplan-Meier method with standard errors based on Greenwood's formula.|Up to 5 years|All evaluable participants||months||95% Confidence Interval|Median
136280|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score|The Working Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
136281|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
136282|NCT00506077|Secondary|Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
136283|NCT00506077|Primary|Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.|The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.|Baseline and 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.||Composite T-score||95% Confidence Interval|Least Squares Mean
136284|NCT00506064|Primary|Objective Sleep Response of Patients|Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)|Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative|Since unable to accrue an adequate number of cases with data, unable to provide analysis.|||||
136285|NCT00506025|Primary|Antimicrobial Activity of Urine From Pregnant Subjects Following Cranberry Juice Cocktail (CJC)|The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).|7 months, from enrollment at 3 months of pregnancy to delivery|a priori for a pilot study||cfu per ml||Full Range|Median
136286|NCT00505934|Secondary|Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.||Consecutive doses||Standard Deviation|Mean
136287|NCT00505934|Secondary|Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
136288|NCT00505934|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)||Treatment period (up to 4 days)|All 19 subjects enrolled in the study were included in the Intent to Treat (ITT) population and are included in this analysis.||Subjects|||Number
136289|NCT00505921|Primary|Participant Progression Free Survival at 2 Years|Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.|2 years|Analysis was per protocol. Nine participants were not eligible for treatment therefore were excluded from analysis.||participants|||Number
136290|NCT00505895|Secondary|Acute Grade II-IV Graft Versus Host Disease (GVHD)|Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.|GVHD grading weekly during first 100 days; Annual examinations for nine year study period|For the acute GVHD analysis, only 48 patients’ data were available.||percentage of participants|||Number
136291|NCT00505895|Primary|Number of Participants With Successful Engraftment at Day 100||Day 100|||participants|||Number
136292|NCT00505778|Secondary|Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6|Is your ulcerative colitis in remission (not active)? Y/N|6 months|ITT Population||Percentage of Participants|||Number
136293|NCT00505778|Secondary|Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6|MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.|6 months|ITT Population||MARS Score||Standard Error|Mean
136294|NCT00505778|Secondary|Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population|Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population||Participants|||Number
136295|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 12, ITT Population|Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|12 months|ITT Population||Percentage of Participants|||Number
136296|NCT00505778|Secondary|Percentage of Patients Remaining in Remission at Month 3, ITT Population|Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|3 months|ITT Population||Percentage of Participants|||Number
136297|NCT00505778|Primary|Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)|Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).|6 months|ITT Population||Percentage of Participants|||Number
136298|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 12 weeks|Participants administered SCoRS at both Baseline and 12 weeks were included in analysis||units on a scale||Standard Deviation|Mean
136299|NCT00505765|Secondary|Change in SCoRS Interviewer Global Rating|Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity by completing a 20-question rating scale via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. After the interview, the interviewer rated subject's overall difficulty on a Global Scale of 1-10. Higher scores indicate greater cognitive impairment.|Baseline, 6 weeks|Participants administered SCoRS at both Baseline and 6 weeks were included in analysis||units on a scale||Standard Deviation|Mean
136300|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, 12 weeks|Only participants with UPSA scores at both Baseline and 12 weeks were included in this analysis||units on a scale||Standard Deviation|Mean
136301|NCT00505765|Secondary|Change in UCSD Performance-Based Skills Assessment (UPSA) Summary Scores|UPSA includes 5 skill areas (subscales) with scores that each range from 0-20. The UPSA yields an overall total score which is the sum of the five subscales and ranges from 0-100. Higher scores are associated with more independent living.|Baseline, week 6|Only participants with UPSA scores at both Baseline and 6 weeks were included in this analysis||units on a scale||Standard Deviation|Mean
136302|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery (MCCB)|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, 12 weeks|Only participants with completed MCCB at both Baseline and 12 weeks were included in analysis||units on a scale||Standard Deviation|Mean
136303|NCT00505765|Primary|Change in MATRICS Consensus Cognitive Battery Composite Score Change|The MATRICS Consensus Cognitive Battery (MCCB) measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Baseline, week 6|Only participants with completed MCCB at both baseline and 6 weeks were included in analysis||units on a scale||Standard Deviation|Mean
136304|NCT00505752|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Percentage of participants|||Number
136366|NCT00504257|Secondary|Occurrence of Grade 3 or 4 Toxicity|Number of participants with Grade 3 or 4 Toxicity based on 278 treatment cycles. Toxicity was graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 4 years|All evaluable participants||participants|||Number
136305|NCT00505752|Primary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who were randomized to study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||2PN oocytes||Standard Deviation|Mean
136306|NCT00505687|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension.|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
136307|NCT00505687|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).||Subjects|||Number
136308|NCT00505687|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|four years|Of the 186 subjects who entered the study, 186 are included in this summary based on the Safety Set (SS).||Subjects|||Number
136309|NCT00505661|Primary|Objective Response Rate Following Treatment With Letrozole|Using RECIST criteria, Objective Response evaluated every 2 months.|2 month intervals for first 2 years|Analysis was per protocol, only 9 of 12 eligible patients were evaluable for response.||participants|||Number
136310|NCT00505635|Secondary|Number of Participants With Response|Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).|Following each 21 day cycles||||||
136311|NCT00505635|Primary|Time to Progression (TTP)|TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Following two 21 day cycles until disease progression|||days||Full Range|Geometric Mean
136312|NCT00505622|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety population||Hours||Standard Deviation|Mean
136313|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety population||Scores on a scale||Standard Deviation|Mean
136314|NCT00505622|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 20, Week 32|Safety Population||Scores on a scale||Standard Deviation|Mean
136315|NCT00505622|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.|Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up|Safety Population - All subjects entering the open-label extension study who took at least 1 dose of perampanel.||Hours||Standard Deviation|Mean
136316|NCT00505518|Primary|Nurse Telepsychiatry Services Satisfaction Questionnaire|The charge nurse’s satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: “not satisfied”, “satisfied”, and “highly satisfied.”|30 days or 60 days (length depended on clinical needs of patients)|||Participants|||Number
136317|NCT00505518|Primary|Patient/Family Telepsychiatry Service Satisfaction Survey|Patients’ (or their family members’ for those who had severe cognitive deficits) satisfaction with the telepsychiatry services were surveyed using a satisfaction questionnaire specifically designed for this study. The satisfaction questionnaire is a scale with three choices: “not satisfied”, “satisfied”, and “highly satisfied.”|30 days or 60 days (length depended on clinical needs of patients)|||participants|||Number
136318|NCT00505518|Primary|Change in Mean Scores on Clinical Global Impressions|Minimum score - 1 (better outcome) Maximum score - 7 (worse outcome)|Baseline, 30 days or 60 days (length depended on clinical needs of patients)|||units on a scale||Standard Deviation|Mean
136332|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT.||Percentage of Participants|||Number
136319|NCT00505414|Secondary|Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change (PGIC) is an instrument where the participant indicates their perceived change at the end of a treatment phase. The overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in tapentadol and morphine at Day 15 (Start of Maintenance Phase) and repeated in participants completing the Maintenance Phase in the Matching Placebo, Tapentadol and Morphine (Day 43).|Day 15 corresponds with PGIC at end of titration phase; Day 43 corresponds with PGIC at end of maintenance phase|Full Analysis Set. Number of participants with data available.||participants|||Number
136320|NCT00505414|Primary|Responder Rates in Maintenance Period|"A responder is a participant in the study that:~completed 28 days of the maintenance phase~had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.~did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43).~A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that fails to meet at least 1 of the 3 criteria is not counted as a responder."|End of the 4 week Maintenance Phase (Day 43)|Full Analysis Set. Number of participants with data available.||participants|||Number
136321|NCT00505375|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years of follow up|||nmol/L||95% Confidence Interval|Geometric Mean
136322|NCT00505284|Secondary|Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period|If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication.|Baseline to Week 15|ITT Population||Participants|||Number
136323|NCT00505284|Secondary|Presence or Absence of Allodynia at Week 15/EOT|Investigators rated subjects’ allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed.|Week 15/EOT|ITT Population||Participants|||Number
136324|NCT00505284|Secondary|Withdrawal Due to Treatment Failure During Double-Blind Dosing Period|Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to ‘lack of therapeutic efficacy,’ the subject was counted as a withdrawal due to treatment failure.|Baseline and Week 15|ITT Population||Participants|||Number
136325|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores|HADS anxiety subscale score=sum of scores for 7 anxiety items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores, 0 to 21.|Baseline and Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
136326|NCT00505284|Secondary|Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores|Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status.|Baseline and Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
136327|NCT00505284|Secondary|Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT|At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF.|Week 15/EOT|Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.||Participants|||Number
136328|NCT00505284|Secondary|Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT|SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity.|Baseline and Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
136329|NCT00505284|Secondary|Change in Average Sleep Interference Scores From Baseline to Week 15/EOT|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep [unable to sleep]). Based on modified BOCF.|Baseline to Week 15/EOT|ITT Population||Scores on a Scale||Standard Deviation|Mean
136330|NCT00505284|Primary|Mean Change in Average Pain Scores From Baseline at Each Study Week|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.|Baseline, Week 1 to Week 17|ITT Population||Scores on a Scale||Standard Deviation|Mean
136331|NCT00505284|Primary|Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score|Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.|Baseline to Week 15/EOT|ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT.||Percentage of Participants|||Number
136333|NCT00505284|Primary|Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)|Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).|Baseline to Week 15/EOT|Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline.||Scores on a Scale||Standard Deviation|Mean
136334|NCT00505076|Secondary|Schizophrenia Cognition Rating Scale (SCoRS) Score|The Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity. The SCoRS Interviewer Global Rating of function has a range 1 to 10. Higher ratings indicate greater impairment.|4 Weeks (Baseline to End of Treatment)|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.||SCoRS Score||Standard Deviation|Mean
136335|NCT00505076|Secondary|UPSA(UCSD Performance-Based Skills Assessment) Summary Score|The UCSD Performance-Based Skills Assessment assessed functional capacity. The UPSA Summary Score has a range from 0 to 120. A higher score indicates less impairment.|Baseline and end of treatment, a total of four weeks.|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.||UPSA Summary Score||Standard Deviation|Mean
136336|NCT00505076|Primary|Composite MATRICS Consensus Cognitive Battery Score|The primary outcome measure is the composite score on the Matrics Consensus Cognitive Battery (MCCB). The MCCB composite score is a standardized mean of the seven domain scores. T-scores are standardized to normative data, and have an estimated mean of 50 and SD of 10 in the general healthy population. Data reduction for analysis of neurocognitive testing used the following steps: i) individual neurocognitive test scores at baseline and follow-up were converted to t-scores; ii) t-scores within the pre-specified cognitive domains measured by more than one test were averaged to obtain a domain-specific t-score; and iii) domain-specific t-scores were averaged to create the MCCB composite score.|4 weeks|Fifty-three participants completed the study: MK-0777 3mg BID: 18; MK-0777 8mg BID: 18; placebo: 17. Three participants dropped out prior to receiving study drug (one randomized to each group) and 1 participant dropped out prior to any post-randomization ratings (randomized to placebo). These participants were not included in analyses.||composite score||Standard Deviation|Mean
136337|NCT00504985|Primary|Patient Fatigue Severity Scores Assessed With MDASI|"Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0–10 numeric scales from not present to as bad as you can imagine. Patients also rate the amount of interference with daily activities caused by symptoms on 0–10 numeric scales from did not interfere to interfered completely."|Survey and blood draw done within 24 hours of patient's Emergency Center visit|Study terminated early due to low recruitment, insufficient data for analysis.|||||
136338|NCT00504777|Secondary|Change From Baseline in HAQ-DI Score|The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set are scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person is required. The HAQ-DI score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent “mild to moderate difficulty”, 1 to 2 as “moderate to severe disability”, and 2 to 3 as “severe to very severe disability”.|Week 24|ITT Population||scores on a scale||Standard Deviation|Mean
136339|NCT00504777|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants with a EULAR response at Week 24 based on a scale of good response, moderate response, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders have a change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders have a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders have a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population||percentage of participants|||Number
136340|NCT00504777|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Response|ACR20/50/70 response defined as greater than or equal to (≥)20 percent (%), 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain, Patient Global Assessment of Disease Activity, Physician Global Assessment of Disease Activity, self-assessed disability based on the Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 24|ITT Population||percentage of participants|||Number
136341|NCT00504777|Primary|Change From Baseline in Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints, or swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (measured in millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A clinically significant improvement in DAS28 was a change of at least 1.2 units.|Week 24|ITT Population||scores on a scale||Standard Deviation|Mean
136342|NCT00504725|Secondary|Verbal Pain Scores|Pain scores rated by the subject on a scale of 0 low - 10 high|baseline, 4 hours, 24 hours and at discharge|||units on a scale||Standard Deviation|Mean
136343|NCT00504725|Secondary|C-reactive Protein (CRP) Serum Levels|The CRP levels were measured 24 hours postoperatively.|24 hours|||pg/ml||Standard Deviation|Mean
136344|NCT00504725|Primary|Interleukin Levels at 24 Hours||24 Hours|||pg/ml||Standard Deviation|Mean
148573|NCT00399542|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
136346|NCT00504660|Primary|12 Month-progression-free Survival for Participants With Anaplastic Tumors|Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.|12 months|Results from TMZ and CCNU treatment arms (Anaplastic Tumor-Glioma Arms 1 & 2) were combined in the final analysis because there was no statistically significant difference between them.||percentage of participants|||Number
136347|NCT00504595|Secondary|Efficacy of ACZ885 (Canakinumab) by Assessing the Response to Treatment Using the Disease Activity Score (DAS28)|DAS28 is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). DAS28 measures the C-reactive protein (CRP) (in mg/L) and the patient's general health (GH). GH is measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. DAS28 = 0.56*√(tender28) + 0.28*√(swollen28) + 0.36*log_e(CRP+1) + 0.014*PGDA + 0.96. Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.||Scores on a scale||Standard Deviation|Mean
136348|NCT00504595|Secondary|Efficacy of ACZ885 by Assessing the Response to Treatment Using the Simple Disease Index (SDAI)|SDAI is derived by the number of swollen joints and tender joints using the 28-joint count (tender28 and swollen28). SDAI measures the high sensitivity C-reactive protein (hsCRP) level, patient's global disease activity (PGDA) and evaluator's global disease activity (EGDA). PGDA and EGDA are measured on a 100 mm Visual Analogue Scale (VAS), ranging from no arthritis activity to maximal arthritis activity. SDAI = tender28 + swollen28 + CRP + (PGDA/10) + (EGDA/10). Lower scores indicate less disease activity.|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.||Scores on a scale||Standard Deviation|Mean
136349|NCT00504595|Primary|Response to Treatment (ACR20) in Adult Patients With Established Rheumatoid Arthritis (RA)|"At each post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures::~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6 weeks and 12 weeks|The Safety Analysis Set consisted of all subjects who received at least one dose of study medication. The analysis used last observation carried forward (LOCF) imputation for missing values.||Participants|||Number
136350|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.|Day 28|||ratio||Standard Deviation|Mean
136351|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.|Day 28|||seconds||Standard Deviation|Mean
136352|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b|"Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose.~PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition."|Day 28|||seconds||Standard Deviation|Mean
136353|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.|Day 28|||percent change of Endogenous FX activity||Standard Deviation|Mean
136354|NCT00504556|Secondary|Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b|Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.|Day 28|||IU/mL||Standard Deviation|Mean
136355|NCT00504556|Secondary|Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of AUCss|3 months|||ng*h/mL||Full Range|Median
136356|NCT00504556|Primary|Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)|liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities|3 months|safety analysis set||percent subjects with liver related MA||95% Confidence Interval|Number
136357|NCT00504556|Secondary|Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b|Median (min, max) values of Cmin,ss; Cmax,ss|3 months|||ng/mL||Full Range|Median
136358|NCT00504556|Secondary|Effects on Biomarker Prothrombin Fragments|Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)|3 months|||pmol/L||Standard Deviation|Mean
136359|NCT00504556|Secondary|Effects on Biomarker D-dimer|Mean (SD) change from baseline in D-dimer|3 months|||ng/mL||Standard Deviation|Mean
136360|NCT00504556|Primary|Adjudicated Incidence of Bleeding Events|Adjudicated Incidence of Bleeding Events during treatment period|3 months|safety analysis set||percent of subjects with outcome event||95% Confidence Interval|Number
136361|NCT00504556|Secondary|Incidence of Major Adverse Cardiac Events MACE)|MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition|3 months|safety analysis set||percent of subjects experiencing events||95% Confidence Interval|Number
136362|NCT00504504|Primary|5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD|Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.|Baseline to 5 Years or until disease progression|||percentage of participants|||Number
136363|NCT00504426|Secondary|Improvement Rate of Pain (Doctor's Judgment)|"Percentage of participants qualified for improvement of pain by doctor's judgement.~Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend.~Improvement defind by stopped or almost stopped or alleviated."|Baseline and Week 4|||Percentage of Participants||95% Confidence Interval|Number
136364|NCT00504426|Primary|Pain (Subjective Symptom)|"Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline.~Regarding VAS (dotted onto a 100 mm line), 0 mm means No Pain and 100 mm means Worst Pain Imaginable."|Baseline and Week 4|||mm||Standard Deviation|Mean
136367|NCT00504257|Secondary|Overall Response Rate (RR)|Overall Response: Complete Response (CR) + Partial Response (PR). To determine the response rate (RR) of the investigational treatment regimen. Response and progression were evaluated in the study by using the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) method or modified Rustin Criteria for CA-125 measurements.|Up to 5 years|Response Rate (RR) evaluable patients included all patients who received at least 2 cycles of treatment and at least one tumor assessment or had demonstrated clinical progression.||participants|||Number
136368|NCT00504257|Secondary|Median Progression Free Survival|"PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.~Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|Up to 5 years|All evaluable participants||months||95% Confidence Interval|Median
136369|NCT00504257|Primary|Six Month Progression Free Survival (PFS)|"Percentage of participants with PFS at six months. PFS: Period from study entry until disease progression, death due to disease progression, or date of last contact.~Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, progression of non-target lesions, or the appearance of one or more new lesions."|6 months per participant|All evaluable participants||percentage of participants||95% Confidence Interval|Number
136370|NCT00504231|Secondary|Assessment of Reactogenicity|Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment|1 week|||participants|||Number
136371|NCT00504231|Secondary|Geometric Mean Titer (GMT) Pre- and Post- Vaccination|GMT before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) IM or Reduced-Dose (9 mg) ID Injections. A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month|||GMT||95% Confidence Interval|Geometric Mean
136372|NCT00504231|Primary|Seroprotection Pre- and Post- Vaccination|Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)|1 month|||% of Participants|||Number
136373|NCT00504166|Primary|Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT|Trabecular number is a three-dimensional measure of the mean inter-trabecular distance; the primary micro-architectural feature measured by high-resolution CT imaging. The parameter was calculated from scans of the distal radius and distal tibia at baseline, 12, and 24 months. The percent change from baseline over these time periods was calculated as the primary outcome measure indicating the micro-architectural status of trabecular bone.|Baseline, 24 months|final statistical analysis was performed per protocol||Percent change||Standard Deviation|Mean
136374|NCT00504153|Secondary|Change in Plasma Vascular Endothelial Growth Factor (VEGF) Levels Over 15 Days|Changes of VEGF will be correlated with response rates and 4-month progression-free survival utilizing the Wilcoxon rank-sum test.|At baseline and day 15|This outcome was not assessed for any of the patients.|||||
136375|NCT00504153|Secondary|Association Between the Incidence of Total C-src and Phosphorylated C-src Expression and Response|Examined by comparing expression in those who have an objective response versus those who do not and in those with and without disease progression at 4 months using Fisher’s exact test.|4 months|This outcome was not assessed for any of the patients.|||||
136376|NCT00504153|Secondary|Incidence of Somatic Mutations|Multivariable analysis of progression-free survival duration will be performed using the Cox (1972) regression model to evaluate the prognostic value of somatic mutations. For the mutational analysis endpoints, genetic mutations will also be correlated with drug activity via Fisher’s exact test for comparisons of responders with non-responders and for comparison of patients progression-free and 4 months vs. those with early progression or death|1 year|This outcome was not assessed for any of the patients.|||||
136377|NCT00504153|Secondary|Response Rate (RR) (Complete or Partial Responders)|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. The response rate is the proportion of subjects who experienced a complete or partial response.|Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months)|||percentage of participants|||Number
136378|NCT00504153|Primary|Progression-free Survival Rate|Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Patients who are still alive and have not progressed will be censored at the date of the last negative examination. A Simon (1989), optimal, two-stage design will be employed. The progression-free survival count will be the proportion of subjects who are alive and progression-free at 4 months.|From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.)|||percentage of participants|||Number
136379|NCT00504075|Secondary|Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.|Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.|Days 1, 2, 3, 5, 9, 14, 21, 32.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.||days||95% Confidence Interval|Median
136380|NCT00504075|Secondary|The Safety of GAMMAPLEX at the Dosage Used in This Study.|"The safety variables used to assess safety were the following:~Adverse events~The number and percent of infusions with at least 1 adverse event(AE) that occurs during an infusion or within 72 hours after the infusion stops~Nature, severity, and frequency of AEs~Suspected unexpected serious adverse reactions (SUSARs)~Vital signs~Clinical laboratory tests and Direct Coombs’ Test~Transmission of viruses~Physical examination"|AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.||% of subjects with product related SAEs||95% Confidence Interval|Number
139120|NCT00476645|Secondary|Stable Disease After One Year|Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria.|12 months|||participants|||Number
136381|NCT00504075|Primary|The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.|The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.|9 days|Any subject who started treatment with GAMMAPLEX and whose central laboratory results taken prior to infusion on Day 1 were within specified protocol parameters, was included in the intent-to-treat (ITT) population for analysis of efficacy and safety.||participants|||Number
136382|NCT00503841|Secondary|Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride||At day -7, prior to surgery, and 1 week post-surgery||||||
136383|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)||Baseline and day 0||||||
136384|NCT00503841|Secondary|Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer||Baseline and day 0||||||
136385|NCT00503841|Primary|Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer||Baseline and day 0|No participants received the study drug erlotinib hydrochloride.|||||
136386|NCT00503776|Secondary|Changes in the Frequency and Types of Dietary Intakes|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24 hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation||05/2013||||
136387|NCT00503776|Secondary|Changes in the Amount and Texture of Food Consumed|Patients are asked to note their food intake in terms of amount and texture over the past 24 hours as measured by 24-hour dietary recalls.|at baseline, at 1 month, 3 months and 6 months post-chemoradiation||05/2013||||
136388|NCT00503776|Secondary|Number of Patients With Oral Mucositis by Grade|Measured by Common Toxicity Criteria (CTC) v. 3.00 = no mucositis (minimum score), 1 = mild mucositis, 2 = moderate mucositis, 3 = severe mucositis, 4 = life-threatening, disabling mucositis, 5 = death (worst score).|6 months after concurrent chemotherapy and radiation|Participants available for 6-month follow-up oral examination. No 6-month follow-up data were available for the following numbers of patients: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2).||participants|||Number
136389|NCT00503776|Secondary|Stimulated and Unstimulated Salivary Production|Unstimulated and stimulated salivary production, measured in mL/minute. Unstimulated salivary production is determined by expectoration of passively accumulated secretions accumulated in three 2-minute periods. Stimulated salivary production is determined by chewing paraffin wax with expectoration of passively accumulated secretions accumulated in three 2-minute periods.|6 months after concurrent chemotherapy and radiation|Patients who underwent salivary testing at 6 months. The following patients were not available at 6- months for testing for salivary production: Arm 1A (1), Arm 1B (4), Arm 2A (3), Arm 2B (2)||mL per minute||Standard Deviation|Mean
136390|NCT00503776|Primary|Number of Patients With Each Degree of Swallowing Dysfunction|Grade of swallowing dysfunction as measured by the modified barium swallow score: grade 1, normal; grade 2, within functional limits; grade 3, mild impairment; grade 4, mild to moderate impairment; grade 5, moderate impairment; grade 6, moderate to severe impairment; grade 7, severe impairment|6 months after concurrent chemotherapy and radiation|One patient (Arm 2B) did not undergo the 6-month study||participants|||Number
136391|NCT00503750|Secondary|Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.|"Complete clinical response (CCR): complete disappearance of all measurable malignant disease. No new malignant lesion, disease-related symptoms or evidence of non-evaluable disease.~Partial response (PR): Reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.~Stable disease (SD): For bidimensionally measurable disease, no decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions."|clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op|||participants|||Number
136392|NCT00503750|Primary|Number of Participants With Complete Pathologic Response.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.~Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response."|assess at 8 weeks|||participants|||Number
136393|NCT00503698|Secondary|Health Related Quality of Life Assessments|Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Observations from end of trial visit is substitute for week 104. Not all subjects provided 'quality of life' data.||scores on a scale||Standard Deviation|Mean
136394|NCT00503698|Secondary|Mortality - Two-year Mortality Rate||week 0, trial termination|No analysis was done since the trial was prematurely terminated before week 104 of the trial. Trial was terminated January 16th, 2009.|||||
136395|NCT00503698|Secondary|Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures|The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).||hospitalisations||Standard Deviation|Mean
136403|NCT00503399|Secondary|Number of Participants With Adverse Events (AEs)|Summary tables of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. Fractures that occurred during the study were collected separately as an additional safety variable. The number of participants experiencing hypercalcemia was summarized for each treatment arm. Hypercalcemia was defined as a serum calcium level corrected for albumin of >2.7 millimole per liter (mmol/L) (10.8 milligram per deciliter [mg/dL]).|Baseline up to 18 months|The safety analysis set included all participants who received study treatment.||participants|||Number
139121|NCT00476645|Secondary|PSA Doubling Time|Number of subjects with prolongation of PSA doubling time|3 months|||participants|||Number
136396|NCT00503698|Secondary|Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)|Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 (end of trial per protocol).||percentage of participants|||Number
136397|NCT00503698|Primary|Mortality - Time to All-cause Death|Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.|week 0, trial termination|FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).||percentage of participants|||Number
136398|NCT00503425|Secondary|Change From Baseline in Bone Density Score at Weeks 48 and 104|Bone density or bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD test results are compared to the ideal or peak BMD of a healthy 30-year-old adult, and results are provided as T-score. A score of 0 means BMD is equal to the norm for a healthy young adult. Differences between observed BMD and that of the healthy young adult norm are measured in units called standard deviations (SDs). The more standard deviations below 0, indicated as negative numbers, lower the BMD higher the risk of fracture. SD + 1 to -1 indicates normal BMD; SD between -1 to -2.5 indicates low bone mass, SD -2.5 or lower indicates osteoporosis. Change in bone density was measured in participants who were not treated with biphosphonates by Dual Energy X-Ray Absorptiometry. Change in bone density was assessed at baseline and at Weeks 48 and 104. Change from baseline in bone density score was reported for all 5 courses.|Baseline, Weeks 48 and 104 (End of treatment)|ITT population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||T-score||Standard Deviation|Mean
136399|NCT00503425|Secondary|Percentage of Participants With EULAR DAS 28 Response at Week 24|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Week 24. EULAR response was based on change from baseline (COB) in DAS28 score and also on actual DAS28 score, at Week 24. DAS28 score= participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: 0.56*√TJC+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score=0-10, higher scores represented higher disease activity. Scores below 2.6: clinical remission, </=3.2: low disease activity, </=5.1: moderate disease activity, above 5.1: severe disease. EULAR Good response: DAS28</=3.2; COB<-1.2. Moderate response: DAS28</=3.2 or >3.2 to </=5.1 or >5.1; COB <-1.2 or <-0.6 to greater than or equal to (>/=)-1.2. No response: DAS28 </=3.2 or > 3.2 to </=5.1 or >5.1; COB <-0.6 to >/=-1.2 or >/=-0.6. EULAR response was reported for 5 courses.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||Percentage of participants|||Number
136400|NCT00503425|Secondary|Percentage of Participants Whose DAS28 Improved by Greater Than (>) 1.2 at Week 24|DAS28 score is a measure of participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated according to following formula: [0.56*√TJC] + [0.28*√SJC] + [0.70*ln ESR] + [0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of </= 3.2 indicated low disease activity, score of </= 5.1 indicated moderate disease activity, and scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses. Participants whose DAS28 score improved by 1.2 score were reported.|Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||Percentage of participants|||Number
136401|NCT00503425|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) at Week 24|DAS28 score is a measure of participant's disease activity calculated using tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: 0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease. Rituximab was administered as needed during episodes of inflammation for up to 5 courses. Change from baseline in DAS28 to Week 24 was reported for all 5 courses.|Baseline, Week 24|ITT Population. Here, number of participants analyzed (N) signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point.||Units on a scale||Standard Deviation|Mean
136402|NCT00503425|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of SAEs.|Baseline up to study withdrawal or follow-up (Approximately 104 weeks)|Safety population included all participants who had received any part of an infusion of study medication.||Participants|||Number
136404|NCT00503399|Secondary|Change From Baseline in Serum Type I Collagen Degradation Fragments (β-CTx) at 3 Months, 6 Months, and 18 Months|β-CTx was used as a biochemical marker of bone turnover/resorption, reflecting collagen breakdown of the bone matrix.|3, 6, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||nanograms per deciliter (ng/dL)||Standard Error|Least Squares Mean
136405|NCT00503399|Secondary|Change From Baseline in Serum Aminoterminal Propeptide of Type I Procollagen (P1NP) at 3 Months, 6 Months, and 18 Months|P1NP was used as a serum biochemical marker of collagen synthesis, reflecting the formation of new osteoid.|Baseline, 3 months, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||micrograms per deciliter (μg/dL)||Standard Error|Least Squares Mean
136406|NCT00503399|Secondary|Change From Baseline in Areal Bone Mineral Density (BMD) at Lumbar Spine, Femoral Neck, and Total Hip at 18 Months|Dual x-ray absorptiometry (DXA) techniques validated this measurement at skeletal sites that are at risk of osteoporotic fracture, such as lumbar spine, femoral neck, and hip.|Baseline, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
136407|NCT00503399|Secondary|Change From Baseline in Axial Compression by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Axial compression was measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated the strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||Newton per millimeter (N/mm)||Standard Error|Least Squares Mean
136408|NCT00503399|Secondary|Change From Baseline in Anterior Bending and Axial Torsion by Finite Element Analysis in the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months: Stiffness and Strength|Anterior bending and axial torsion were measured using HR-QCT-based finite element analysis to determine stiffness and strength of T12. Stiffness evaluated strength of the vertebral body, defined as the slope of the initial step of the force-displacement curve. Strength of the vertebral body was evaluated under compressive loading conditions using computer simulation. LS Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||Newton/millimeter/radian (N/mm/rad)||Standard Error|Least Squares Mean
136409|NCT00503399|Secondary|Change From Baseline in High Resolution Quantitative Computerized Technology (HR-QCT) of Integral and Trabecular Bone Mineral Density (BMD) of the 12th Thoracic Vertebra (T12) at 6 Months and 18 Months|Three-dimensional (3-D) microstructure variables of T12 were assessed by HR-QCT. In contrast with regular QCT that assessed 3 millimeter (mm) slide thickness, HR-QCT used segmentation of 1 single vertebra with approximately 100 consecutive slides reconstructed at 300-400 micrometer (µm) slice increments covering the complete vertebral body. Least Squares (LS) Means were adjusted for age, baseline P1NP, fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months, 18 months|The analysis population was the full analysis set (FAS), which included all randomized participants who received at least 1 dose of study medication.||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
136410|NCT00503399|Secondary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Technology (QCT) at 6 Months|Least Squares (LS) Means were adjusted for age, baseline propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 6 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
136411|NCT00503399|Primary|Change From Baseline in Lumbar Spine Volumetric Trabecular Bone Mineral Density (BMD) by Quantitative Computerized Tomography (QCT) at 18 Months|Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.|Baseline, 18 months|The analysis population was the primary efficacy population, which included all randomized participants who received at least 1 dose of study medication (full analysis set) and had a lumbar spine volumetric trabecular BMD measurement at baseline and at ≥1 post-baseline visit.||milligram per cubic centimeter (mg/cm^3)||Standard Error|Least Squares Mean
136412|NCT00503308|Primary|Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)|We measured decisional conflict, the primary outcome of the study, using the English or Spanish language 10-item Low Literacy Decisional Conflict Scale. We considered a DCS score of 25 or less to be low, corresponding to limited conflict. All questions have 3 response categories: yes, no, unsure. Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. The final scores range from 0(no decisional conflict) to 100 (extremely high decisional conflict).|same day as HIV test counseling (cross-sectional study)|||scores on scale||95% Confidence Interval|Mean
136413|NCT00503113|Secondary|Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.|The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.|Baseline and 9 months|PP Population||mg/g||Standard Deviation|Mean
136414|NCT00503113|Secondary|Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.||Baseline and 9 months|PP Population||mg/g||Standard Deviation|Mean
136417|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using CG Formula)|Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population||mL/min||Standard Deviation|Mean
136418|NCT00503113|Secondary|Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)|Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population||mL/min||Standard Deviation|Mean
136419|NCT00503113|Secondary|Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)|Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|PP Population||mL/min||Standard Deviation|Mean
136420|NCT00503113|Primary|Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)|The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients’ actual body surface area) after 9 months (or 40 weeks) of treatment.|Baseline and 9 months|Per Protocol (PP) Population||mL/min||Standard Deviation|Mean
136421|NCT00503009|Secondary|Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4|eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
136422|NCT00503009|Secondary|Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4|FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
136423|NCT00503009|Secondary|Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4|PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
136424|NCT00503009|Primary|Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4|The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.|Days 1 through 4||||||
136425|NCT00502996|Secondary|Mean Value of Inflamed Joints|The efficacy of rituximab was assessed by evaluating inflamed joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||number of inflamed joints||Standard Deviation|Mean
136426|NCT00502996|Secondary|Mean Values of Pain and Activity Based on Visual Analogue Scale|Pain assessment was assessed by using a VAS (0=no pain to 100=unbearable pain). Disease activity was also evaluated by participants and investigators by using a VAS (0=no disease activity to 100=maximum disease activity).|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||Scores on scale||Standard Deviation|Mean
136427|NCT00502996|Secondary|Mean Values of Globular Sedimentation Velocity|Globular sedimentation velocity is a component of ACR.|Screening ((Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||millimeters per hour||Standard Deviation|Mean
136428|NCT00502996|Secondary|Mean Values of C Reactive Protein|C Reactive Protein (CRP) is a component of ACR. CRP is a marker of inflammation.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||milligrams per liter||Standard Deviation|Mean
136429|NCT00502996|Secondary|Mean Value of Quality of Life (Health Assessment Questionnaire – Disease Index)|Health Assessment Questionnaire - Disease Index (HAQ-DI) indicates how the disease affected participant’s activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Screening (Days -28 to 0), Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||Scores on scale||Standard Deviation|Mean
136430|NCT00502996|Secondary|Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria|American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender joints and swollen joints, as well as for three of the additional five ACR core set variables: patient’s assessment of pain using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain); patient’s global assessment of disease activity and physician’s global assessment of disease activity using a VAS (0=no disease activity to 100=maximum disease activity); health assessment questionnaire (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant; C-reactive protein and globular sedimentation velocity.|Week 1, Week 12, and Week 24|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||participants|||Number
136431|NCT00502996|Secondary|Mean Value of Painful Joints|The efficacy of rituximab was assessed by evaluating painful joints.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||number of painful joints||Standard Deviation|Mean
136432|NCT00502996|Secondary|Mean Duration of Morning Joint Stiffness|The efficacy of rituximab was assessed by evaluating mean duration of morning joint stiffness.|Screening ((Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|All eligible participants who received one treatment dose of rituximab were considered for this outcome measure.||Minutes||Standard Deviation|Mean
136602|NCT00502242|Secondary|Change From Baseline in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L]) at 4, 12, 24, and 52 Weeks Following Conversion to SRL|Parameters assessed included (all fasting) total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-densitylipoprotein cholesterol (HDL-C).|4, 12, 24, and 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mmol/L||Standard Error|Mean
136433|NCT00502996|Secondary|Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit|The mean aspartate transaminase (AST) and alanine transaminase (ALT), Alkaline phosphatase (AP), and Lactic dehydrogenase (LDH) concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||International units/liter||Standard Deviation|Mean
136434|NCT00502996|Secondary|Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit|The mean concentration of potassium, chlorine, sodium and phosphorus for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||millimoles per liter||Standard Deviation|Mean
136435|NCT00502996|Secondary|Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit.|The mean concentration of cholesterol, uric acid, urea, creatinine, calcium, total bilirubin and serum total proteins (STP) for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||mg/dL||Standard Deviation|Mean
136436|NCT00502996|Secondary|Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose)|The mean albumin and glucose concentration for each participant was estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||g/dL||Standard Deviation|Mean
136437|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets)|The mean leucocytes and platelets concentration for each participant was estimated at Screening, at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||10^9 cells/liter||Standard Deviation|Mean
136438|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes)|The mean erythrocyte concentration for each participant was estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||10^12 cells/liter||Standard Deviation|Mean
136439|NCT00502996|Secondary|Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume)|Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant was estimated at Screening and EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The analysis was performed on safety population. Eligible participants who received one treatment dose of Rituximab, have completed the follow-up period, Visit 11, and end of follow-up period in safety conditions and also who had been withdrawn or not from the study were included in the safety population.||femtoliters||Standard Deviation|Mean
136440|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils)|The hematology parameters (hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, and basophils) for each participant were estimated at Screening and at EOT.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||percentage of cells||Standard Deviation|Mean
136441|NCT00502996|Secondary|Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration)|The values of hemoglobin (Hb) and mean corpuscular hemoglobin concentration (MCHC) for each participant were estimated at Screening and at EOT visit.|Screening (Days -28 to 0) and EOT (Week 24)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||g/deciliter (dL)||Standard Deviation|Mean
136442|NCT00502996|Primary|Number of Participants With AEs of Special Interest During the Study|Adverse event of special interest during the study treatment and follow up period included infections. The participants with AEs of special interest were reported at Screening, End of treatment (EOT), and End of Follow-up (EOFU) visit.|Screening (Days -28 to 0), EOT (Week 24), and EOFU (Week 48)|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
136443|NCT00502996|Primary|Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs|"An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A SAE is any experience that suggested a significant risk, contraindication, caution, and at any dose, fulfills, at least, one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment. Relationship between AEs and medication under investigation was evaluated through the classification Yes and No. A relationship classified as Yes implied a significant causal relationship with the medication under investigation which was evaluated based on enough evidences, facts or arguments."|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
136603|NCT00502242|Secondary|Percentage of Participants Using Red Blood Cell Production Stimulants (Erythropoiesis Stimulating Agents [ESAs])||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
136444|NCT00502996|Primary|Number of Participants With AEs According to Degree of Intensity|An AE is any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. The Intensity of AEs was classified as Grade 1, Grade 2, Grade 3 and Grade 4. Grade 1: Discomfort was noticed, but the normal daily activity was not interrupted. Grade 2: Discomfort was enough to reduce the normal daily activity. Grade 3: There was disability for work or develop normal daily activities. Grade 4: It represented an immediate threat to life (these events were reported as SAEs).|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
136445|NCT00502996|Primary|Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death|An Adverse event (AE) was considered any unfavorable medical event in a participant of clinical research who received the study drug and that not necessarily had a causal relationship with this treatment. An AE could, therefore, being any unfavorable sign and non-intentional, symptom or disease temporarily related with the use of a medicinal product, considered or not related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AEs. A serious adverse event (SAE) is any experience that suggested a significant risk, contraindication, caution, and at any dose fulfills at least one of the following criteria: adverse event considered as fatal (resulting in death), life threatening, defect of birth/congenital abnormality, required hospitalization or extension of hospital length of stay, significant medical intervention, resulted in significant disability/impairment.|Up to Week 48|The safety population included all eligible participants who received one treatment dose of rituximab and have completed the follow up period (Week 48) regardless of whether withdrawn or not from the study.||participants|||Number
136446|NCT00502944|Primary|Linkage to Care of Newly Diagnosed HIV Infected Participants|We define linkage to care as attendance at a first HIV clinic appointment where the following 3 events occur: 1) introduction to an HIV care primary provider; 2) receipt of confirmatory Western Blot HIV test results; and 3) phlebotomy for CD4 cell count and HIV RNA level.|Assessed within 8 weeks after receipt of reactive rapid HIV test results|DSMB recommended the trial be ended early for likely inability to obtain this primary outcome. Thus the outcomes reported in paper are the secondary and other pre-specified outcomes listed.||participants|||Number
136447|NCT00502944|Other Pre-specified|Test Acceptance Rate|Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test.|Assess on day subject enrolled into the study|Number of participants analyzed equals the number of participants offered a rapid HIV test. Many participants left the ED before the opportunity was available to offer the test.||participants|||Number
136448|NCT00502944|Other Pre-specified|Test Offer Rate|The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test.|Assess on day subject enrolled into the study|||participants|||Number
136449|NCT00502944|Secondary|Overall Rapid HIV Testing Rate|We defined the overall rapid HIV testing rate as the number of participants tested for HIV using the rapid test among those randomized to potentially be tested in each arm.|Assess on day subject enrolled into the study|Intention to treat analysis||participants|||Number
136450|NCT00502905|Primary|Number of Participants With Successful Engraftment|Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28.|Study period one week prior to transplant through post Day 28|Analysis per protocol.||participants|||Number
136451|NCT00502853|Secondary|X-Rays: Left Hand Total Score|Left hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
136452|NCT00502853|Secondary|X-Rays: Right Hand Total Score|Right hand total scores as measured by X-rays examining erosion and joint space narrowing. Total score was calculated as the sum of the erosion score and the joint space narrowing score and scores ranged from 0 (best possible outcome) to 180 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
136453|NCT00502853|Secondary|Joint Space Narrowing - Left Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 x 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
136454|NCT00502853|Secondary|Joint Space Narrowing - Right Hand|Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4. A normal joint space was scored 0. A score of 2 was allowed to a focal narrowing of the joint or to a joint space not sufficiently narrowed to be scored 2. The score of 1 was not to be used when the reader was unsure whether there was joint space narrowing. A generalized narrowing leaving more than 50% of the original joint space present was scored 2. A generalized narrowing leaving less than 50% of the original joint space present was scored 3, and a subluxation of a joint was also scored 3. A bony ankylosis or a complete luxation of the joint was scored 4. A total of 13 joints were evaluated for narrowing and the scores were summed (13 times [x] 4 [maximum per joint]). Each sum was normalized to a scale of 0 (best possible outcome) to 100 (worst possible outcome).|Baseline and Week 24|Safety Population; only participants with values at both Baseline and Week 24 were included in the analysis.||units on a scale||Standard Deviation|Mean
136455|NCT00502853|Secondary|Erosion Score - Left Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population; n=number of participants with values for analysis at the specified timepoints.||units on a scale||Standard Deviation|Mean
136456|NCT00502853|Secondary|Erosion Score - Right Hand|The erosion score per joint of the hands can range from 0 to 5. Erosions were scored 1 if they were discrete but clearly present, and 2 or 3 if they were larger, depending on the surface area of the joint involved. A score of 3 was given if the erosion was large and extended over the imaginary middle of the bone. A score of 5 was given if a complete collapse of the joint was present or if the full surface of the joint was affected. In each joint, individual erosions were summed up to a maximum of 5. The maximal erosion score for each hand was thus 80, considering the 16 areas for erosions per hand.|Baseline and Week 24|Safety Population||units on a scale||Standard Deviation|Mean
136457|NCT00502853|Secondary|Percentage of Total B-lymphocytes|Concentration of all B-lymphocytes subtypes was assessed.|Baseline and Weeks 4, 12, and 24|Safety Population||percentage of cells||Standard Deviation|Mean
136458|NCT00502853|Secondary|Hematocrit Concentration (%)||Baseline and Weeks 4, 12, and 24|Safety Population||percentage||Standard Deviation|Mean
136459|NCT00502853|Secondary|Total Immunoglobulin (Ig) Concentrations|Total Ig concentrations as measured by milligrams per milliliter (mg/mL).|Baseline and Weeks 4, 12, and 24|Safety Population||mg/mL||Standard Deviation|Mean
136460|NCT00502853|Secondary|Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations|RF IgM concentrations measured by international units per milliliter (IU/mL). RF is an antibody reacting against the fragment, crystallizable (Fc) region of IgG. Quantitative measurements have shown a prognostic value in distinguishing between progressive and non-progressive disease in early RA, a correlation with radiologically determined joint damage, and relation with clinical improvement after disease-modifying anti-rheumatic treatment.|Baseline and Weeks 4, 12, and 24|Safety Population||IU/mL||Standard Deviation|Mean
136461|NCT00502853|Secondary|Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count|Anti-CCP autoantibodies count measured by units per milliliter (U/mL). The anti-CCP autoantibodies bind antigenic determinants that contain the unusual amino acid citrulline. The anti-CCP antibody is a highly specific diagnostic test of RA (though with variable sensitivity) and a marker of joint damage with high prognostic significance.|Baseline and Weeks 4, 12, and 24|Safety Population||U/mL||Standard Deviation|Mean
136462|NCT00502853|Secondary|C-Reactive Protein (CRP)|CRP measured by milligrams per deciliter (mg/dL). High levels of CRP are indicators of active inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population||mg/dL||Standard Deviation|Mean
136463|NCT00502853|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was determined using the Westergren method. ESR measures how fast red blood cells (erythrocytes) fall to the bottom of a fine glass tube that is filled with the participant's blood. The higher the sedimentation rate the greater the inflammation.|Baseline and Weeks 4, 12, and 24|Safety Population||mm/hr||Standard Deviation|Mean
136464|NCT00502853|Secondary|DAS28 Score|DAS28 calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (≤) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 12, and 24|Safety Population||units on a scale||Standard Deviation|Mean
136465|NCT00502853|Secondary|Patient’s Global Assessment of Pain|The participant’s assessment of their current level of pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line was described as “no pain” and the right-hand as “unbearable pain”. The participant was asked to mark the line corresponding to their current level of pain and the distance from the left edge was recorded.|Baseline and Weeks 4, 12, and 24|Safety Population||mm||Standard Deviation|Mean
136466|NCT00502853|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis (RA). It consist of 20 items referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item within a domain was scored on a 4-point Likert scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The highest score reported by the participant for a domain determined the score for that domain. The overall disability index is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 4, 12, and 24|Safety Population||units on a scale||Standard Deviation|Mean
136467|NCT00502853|Primary|Relative Enhancement (RE) Score|A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using “dynamic” MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (REE) and its “steady state” condition (RE).|Baseline, Weeks 4 and 24|Safety Population||percent||Standard Deviation|Mean
136477|NCT00502840|Secondary|Patient's Global Assessment of Disease Activity|"Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
136468|NCT00502853|Primary|Early Enhancement Rate (REE)|A low cost, low field dedicated extremity MRI unit was used, which is specifically designed for the examination of peripheral joints. In addition to the standard OMERACT-RAMRIS scoring system, additional data were elaborated by using “dynamic” MRI, i.e. Contrast-Enhanced Dynamic MRI (DCE-MRI). This method evaluates the diffusion of the contrast mean in a series of very short sequences thus providing a diffusion curve which is proportionate to the extent of inflammation in the synovial membrane. Numerical parameters used with this method are the slope in the initial phase (rate of early enhancement - REE) and its “steady state” condition (relative enhancement - RE). REE per second during the first 55 seconds was calculated according to the formula REE55 = (S55-S0)/(S0x55)x100%. The REE shows the slope of the curve of contrast uptake tangential to the α angle and is steeper if inflammation is higher.|Baseline, Weeks 4 and 24|Safety Population||percent per second||Standard Deviation|Mean
136469|NCT00502853|Secondary|Ritchie Articular Index Scores|The Ritchie Articular Index is a graded assessment of tenderness in 26 joint regions. The sum of the grades of tenderness (0=not tender, 1=tender, 2=tender and causes wince, and 3 tender, causes wince and effort to withdraw) elicited by applying firm pressure over the joint margin of articular joints (such as shoulders, elbow, wrists, hips). The scores ranged from 0 (no tenderness) to 78 (most severe tenderness).|Baseline and Weeks 4, 12, and 24|Safety Population||units on a scale||Standard Deviation|Mean
136470|NCT00502853|Primary|OMERACT RAMRIS Erosion Score|MRI bone erosion measures a sharply marginated bone lesion, with correct juxta-articular localization and typical signal characteristics, which is visible in 2 planes with a cortical break seen in at least 1 plane. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) scored separately. Scale is 0–10 based on proportion of eroded bone compared to assessed bone volume (0=no erosion; 1=1%–10% of bone eroded; 2=11%–20%, etc). For long bones, assessed bone volume is from articular surface (or best estimated position if absent) to depth of 1 centimeter (cm); in carpal bones it is the whole bone. Total erosion score=sum of individual scores for an overall range of 0–230, where 0=no erosion and 230=most severe erosion. Change in erosion=Follow-up erosion score - baseline score.|Baseline, Week 4, and Week 24|Safety Population||units on a scale||Standard Deviation|Mean
136471|NCT00502853|Primary|OMERACT RAMRIS Bone Edema Score|Extension and degree of bone edema in the wrist according to the RAMRIS score developed by OMERACT. Bone edema is a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) is scored separately. The scale of 0–3 was based on the proportion of bone with edema, as follows: 0=no edema; 1=1 percent (%) to 33% of bone was edematous; 2 = 34%–66% of bone was edematous; and 3= 67%–100% of bone was edematous. Total bone edema score=sum of the individual scores for an overall range of 0–69, where 0=no edema and 69=most severe edema. Change in bone edema = follow-up bone edema score - baseline score.|Baseline, Weeks 4 and 24|Safety Population||units on a scale||Standard Deviation|Mean
136472|NCT00502853|Primary|Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score|Extension and degree of synovitis in wrist according to RAMRIS score developed by OMERACT. Synovitis is an area in synovial compartment that shows above normal post-gadolinium enhancement of a thickness greater than width of normal synovium. Synovitis is assessed in 3 wrist regions (distal radioulnar joint; radiocarpal joint; intercarpal and carpometacarpal joints) and in each metacarpophalangeal (MCP) joint. 1st carpometacarpal joint and 1st MCP joint are not scored. Score 0 is normal, and 1–3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score=the sum of the individual scores (3 wrist regions [range 0-9] or 4 MCP joints [range 0-12]) for an overall range of 0–21, where 0=no damage and maximum score [9, 12, or 21]=most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|Baseline, Week 4, and Week 24|The Safety Population included all participants who received any portion of the rituximab dose and was used for efficacy and safety analyses.||units on a scale||Standard Deviation|Mean
136473|NCT00502840|Secondary|Rheumatoid Factor (RF)|RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||IU/mL||Standard Deviation|Mean
136474|NCT00502840|Secondary|Erythrocyte Sedimentation Rate|ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm/hr||Standard Deviation|Mean
136475|NCT00502840|Secondary|C-Reactive Protein|CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
136476|NCT00502840|Secondary|Patient's Assessment of Pain|"Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as unbearable pain."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
136501|NCT00502775|Secondary|Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & two in the FFNS group recorded no data during the two-week treatment period.||Score on a Scale||Standard Error|Mean
136478|NCT00502840|Secondary|Physician's Global Assessment of Disease Activity|"Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Baseline and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||mm||Standard Deviation|Mean
136479|NCT00502840|Secondary|Tender Joint Count|Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||tender joints||Standard Deviation|Mean
136480|NCT00502840|Secondary|Swollen Joint Count|Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||swollen joints||Standard Deviation|Mean
136481|NCT00502840|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course|ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit.|24 weeks after each course|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
136482|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - General Heath Perceptions|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136483|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Vitality|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136484|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Social Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136485|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Well-Being|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136486|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Emotional Role Functioning|SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136487|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Role Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136488|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Bodily Pain|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136489|NCT00502840|Secondary|SF-36 Domain Scores by Treatment Course - Physical Functioning|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136490|NCT00502840|Secondary|SF-36 MCS by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136491|NCT00502840|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course|SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136500|NCT00502775|Secondary|Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)|Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.|Baseline, Day 15 or if Early Withdrawal Day|Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ data.||Score on a Scale||Standard Error|Mean
136492|NCT00502840|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course|FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136493|NCT00502840|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course|HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136494|NCT00502840|Secondary|Percentage of Participants Achieving a Response By EULAR Category and Treatment Course|Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score > 5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
136495|NCT00502840|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.|Week 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
136496|NCT00502840|Secondary|DAS28 Score by Treatment Course and Follow-up (FU) Visit|DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
136497|NCT00502840|Primary|Change From Baseline in DAS28 Score at Week 24|DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.|Week 24|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form, received at least 1 dose of study medication, and where the DAS28 was measured at least once under study medication.||scores on a scale||Standard Deviation|Mean
136498|NCT00502801|Secondary|Clinical Response Rates at the Late Follow-up Assessment.|"The table below shows the percentage of subjects who had a clinical response of “clinical cure” at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of clinical cure is defined as no further antibacterial therapy needed for treatment of the infection."|28 to 35 days after last dose of study therapy|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.||Percentage of participants|||Number
136499|NCT00502801|Primary|Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.|The table below shows the percentage of subjects who had a clinical response of “clinical cure” at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of “clinical cure” is defined as no further antibacterial therapy needed for treatment of the infection.|5 to 21 days after the last dose of study therapy, or at early termination.|Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.||Percentage of participants||95% Confidence Interval|Number
136502|NCT00502775|Secondary|Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)|Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.|Baseline and Weeks 1-2|Two subjects in the placebo group & three in the FFNS group recorded no data during the two-week treatment period.||Score on a Scale||Standard Error|Mean
136503|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136504|NCT00502775|Secondary|Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136505|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136506|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136507|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)|Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136508|NCT00502775|Secondary|Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136509|NCT00502775|Secondary|Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136510|NCT00502775|Secondary|Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)|Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.|Baseline and Weeks 1-2|||Score on a Scale||Standard Error|Mean
136511|NCT00502775|Primary|Mean Change From Baseline in the Nighttime Symptom Score (NSS)|Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.|Baseline and Weeks 1-2|One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.||Score on a Scale||Standard Error|Mean
136512|NCT00502697|Secondary|Maternal Length of Stay at Delivery|Number of maternal hospital days associated with delivery|Hospital discharge point following delivery|Of the 211 participants, data on length of stay at delivery were available for 194 women. The most common reason for the lack of this information was that the birth did not take place at the study’s medical center.||days||Full Range|Median
136513|NCT00502697|Primary|Infant Gestational Age|Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.|Time of delivery|ITT analysis used with all participants that birth information could be obtained.||weeks||Inter-Quartile Range|Median
136514|NCT00502671|Secondary|Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.||percentage of participants|||Number
136524|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136515|NCT00502671|Primary|Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE|The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.|Up to 25 weeks (from Baseline to the end of safety follow-up)|Safety Population.||percentage of participants|||Number
136516|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136517|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136518|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136519|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Subjects|||Number
136520|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136521|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136522|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136523|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.|At Days 0, 21 and 42 and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136525|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.|At Days 0, 21 and 42 and at Month 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136526|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136527|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136528|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136529|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136530|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136531|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136532|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136533|NCT00502593|Primary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A|Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.|At Days 0, 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136576|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Fold||95% Confidence Interval|Geometric Mean
136534|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136535|NCT00502593|Primary|Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136536|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136537|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136538|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136539|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136540|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136548|NCT00502593|Secondary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response|A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24.|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
136541|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136542|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136543|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136544|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.|At Days 21, and 42, and at Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136545|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136546|NCT00502593|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn’s disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison’s disease). skin disorders (such as psoriasis, vitiligo, Raynaud’s phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.|Throughout the entire study period, from Day 0 to Month 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136547|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.|At Months 6, 12 and 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
136587|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Titer||95% Confidence Interval|Geometric Mean
136549|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136550|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136551|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136552|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136553|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136554|NCT00502593|Primary|Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A|Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.|At Days 21 and 42 and Months 6, 12 and 24|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136555|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination."|During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136556|NCT00502593|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.|During the entire study (Day 0 to Month 24)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136557|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
136558|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136559|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase B of the study.|At Days 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Subjects|||Number
136560|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase C of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.||Subjects|||Number
136561|NCT00502593|Secondary|Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies|A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.|At Days 21 and 42|The analysis was based on the According to protocol (ATP) cohort for immunogenicity, which included all subjects meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria and no major deviation from protocol, for whom immunogenicity data for at least one antigen were available.||Subjects|||Number
136562|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
136563|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
136564|NCT00502593|Secondary|Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease|Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study|At Days 0, 21 and 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
136565|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature > 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects whom safety data were available.||Subjects|||Number
141410|NCT00457977|Primary|Serotype Opsonization Titers|Opsonophagocytosis activity (OPK) serotype specific geometric means|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.||titers||95% Confidence Interval|Geometric Mean
136566|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.|During the 7-day follow-up period after each vaccination|The analysis was based on theTotal Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136567|NCT00502593|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.|During the 7 day follow-up period after each vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.||Subjects|||Number
136568|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
136569|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
136570|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
136571|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
136572|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
136573|NCT00502593|Primary|Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
136574|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Fold||95% Confidence Interval|Geometric Mean
136575|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Fold||95% Confidence Interval|Geometric Mean
136604|NCT00502242|Secondary|Percentage of Participants With Hemoglobin Levels ≤100 Grams Per Liter (g/L)||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population||percentage of participants|||Number
136577|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Fold||95% Confidence Interval|Geometric Mean
136578|NCT00502593|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Fold||95% Confidence Interval|Geometric Mean
136579|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
136580|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
136581|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Subjects|||Number
136582|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 42|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
136583|NCT00502593|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease|A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
136584|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 24|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
136585|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Month 12|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
136586|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Month 6|The analysis was performed on the According-to-Protocol cohort for persistence, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component on Month 6/Day 180, Month 12 and Month 24.||Titer||95% Confidence Interval|Geometric Mean
136588|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination||Titer||95% Confidence Interval|Geometric Mean
136589|NCT00502593|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.|At Day 0|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, e.g. for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
136590|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)|Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.||scores on a scale||Standard Error|Mean
136591|NCT00502320|Secondary|Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)|Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.||scores on a scale||Standard Error|Mean
136592|NCT00502320|Primary|Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)|Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.|Monthly for duration of treatment (up to 4 months)|Intention to Treat analysis; excludes one screen failure.||scores on a scale||Standard Error|Mean
136593|NCT00502242|Secondary|Percentage of Participants With Hyperkalemia|Hyperkalemia defined as serum potassium >5.6 millimoles per liter (mmol/L)|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
136594|NCT00502242|Secondary|Percentage of Participants With Malignancy|Includes treatment-emergent adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferredterm in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population||percentage of participants|||Number
136595|NCT00502242|Secondary|Percentage of Participants With Angioedema|Includes treatment-emergent adverse events based on categorization by the investigator as angioedema, regardless of the event preferred term in MedDRA.|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population||percentage of participants|||Number
136596|NCT00502242|Secondary|Percentage of Participants With an Infection|Includes treatment-emergent adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA.)|From Day 1 of Ramipril/Placebo to 52 weeks after SRL conversion|Safety population||percentage of participants|||Number
136597|NCT00502242|Secondary|Percentage of Participants Using Statins||Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population; n=number of participants analyzed for the specified parameter at a given visit.||percentage of participants|||Number
136598|NCT00502242|Secondary|Percentage of Participants With Graft Loss at 24 and 52 Weeks Following Conversion to SRL|Graft loss was defined as physical loss (nephrectomy orretransplantation), functional loss (requiring dialysis for ≥56days with no return of graft function), or death.|24 weeks and 52 weeks after conversion|mITT population||percentage of participants|||Number
136599|NCT00502242|Secondary|Number of Participants With BCAR by Severity of First BCAR|Severity was summarized by type (antibody versus T-cell) and by phase: post-SRL (where both on-therapy and off-therapy events are included) and post-SRL (on-therapy). BCAR was categorized using Banff criteria as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate [mod]), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (mod), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category. For participants with T-cell BCAR (post-SRL and post-SRL On -Therapy) the p-value could not be calculated and all events were mild in severity.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; only participants with BCAR were included in the anlaysis.||participants|||Number
136600|NCT00502242|Secondary|Percentage of Participants With First BCAR at 24 and 52 Weeks Following Conversion to SRL|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. Participants without BCAR were censored at the time of withdrawal from the study. Defined as the first BCAR occurring on therapy following conversion to SRL based on the mITT population. Time to first BCAR was defined as the date of first BCAR to date of the first dose of SRL (in weeks). Percentages were estimated using the Kaplan-Meier method for time to event data.|24 weeks and 52 weeks after conversion|mITT population; includes BCAR occurring in the On-Therapy and Off-Therapy Periods||percentage of participants||95% Confidence Interval|Number
136601|NCT00502242|Secondary|Biopsy-Confirmed Acute Rejection (BCAR) - Number of Participants With an Event|BCAR was defined according to updated Banff criteria (1997)for renal allograft rejection. The time to the first BCAR was defined as the date of first BCAR to the date of the first dose of SRL (in weeks). Participants without BCAR were censored at the time of withdrawal from the study.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population; includes BCAR occurring in On-Therapy and Off-Therapy Periods.||participants|||Number
136605|NCT00502242|Secondary|SRL Time-Normalized Trough Concentration (Cmin,TN) by Time Interval|Cmin,TN was determined for SRL using the area method for the intervals: 0–2 weeks, >2–4 weeks, >4–12 weeks, >12–24 weeks, >24–36 weeks and >36–52 weeks using the equation:Cmin,TN = AUCi-j/timej-timeiwhere AUC is the area under the concentration-time curve, i is the beginning of the interval and j is the end of the interval. Cmin,TN was calculated for participants who did not dropout of studies, but were missing concentrations at the interval endpoints by carrying the last observed concentration forward to the interval endpoint.|From Day 1 of SRL conversion to 52 weeks after conversion|Safety population; n=number of participants assessed for the specified parameter for the given time interval; only participants dosed throughout the interval were included.||ng/mL||Standard Deviation|Mean
136606|NCT00502242|Secondary|Percentage of Participants With Potentially Clinically Important Blood Pressure (BP) Values by Diastolic and Systolic BP Category|BP values of potential clinical importance were recorded and categorized as follows: diastolic BP (DBP) ≤50 millimeters of mercury (mmHg) or ≥110 mmHg and systolic BP (SBP) ≤90 mmHg and ≥180 mmHg. Data were summarized for the on-therapy period and the off-therapy period and for the pre-SRL period.|Baseline, Pre-SRL (from first dose of ramipril/placebo up to SRL conversion), On-Therapy (up to 52 weeks after SRL conversion), and Off-Therapy Period (up to 56 weeks after SRL conversion)|Safety population||percentage of participants|||Number
136607|NCT00502242|Secondary|Fraction of Albumin (Milligrams Per Deciliter [mg/dL]) to Protein (mg/dL) in Urine at 24 and 52 Weeks After Conversion to SRL|Baseline fraction was the last value of the pre-SRL conversion period. Only the last value of U p/c or U alb/c was used for analysis if multiple measurements occurred in the same data anlysis interval. Fraction of albumin and protein was calculated only when urine protein was 6.2 mg/dL or higher. For urine albumin, if the value was reported as '<xx.x', the numerical portion of the value was used in the calculation of fraction of albumin and protein.|24 weeks and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.||(mg/dL)/(mg/dL)||Standard Deviation|Mean
136608|NCT00502242|Secondary|Abbreviated Modified Diet in Renal Disease (MDRD) Glomerular Filtration Rate (GFR) at Weeks 12, 24, and 52 Following Conversion to SRL|Calculated in millimeters per minute per 1.73 square meters (mL/min/1.73m^2). Age and corresponding creatinine at each visit (Weeks 12, 24, and 52) were used to calculate GFR.|12, 24, and 52 weeks following conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit. Includes measures collected from On-Therapy and Off-Therapy Periods.||mL/min/1.73 m^2||Standard Deviation|Mean
136609|NCT00502242|Secondary|Percentage of Participants Who Discontinued SRL Therapy at 24 and 52 Weeks Following Conversion to SRL|Defined as the percentage of participants who stop SRL (as test article) between the first day of SRL and either Week 24 or Week 52 following conversion to SRL. If a participant had a >14 day gap in SRL use, the stop date of SRL was the date of the last SRL use before it was re-initiated. Participants who early terminate SRL at Week 24 were defined as having SRL stop day less than or equal to (≤) Day 190 (selected as the midpoint between Weeks 24 and 30). Participants who early terminate SRL at Week 52 were defined as having SRL stop day ≤Day 337 (selected as the midpoint between Weeks 44 and 52).|24 weeks and 52 weeks after conversion|mITT population||percentage of participants|||Number
136610|NCT00502242|Secondary|U Alb/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U alb/c was measured in mg/mg. Baseline U alb/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n=number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U alb/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.||mg/mg||Standard Deviation|Mean
136611|NCT00502242|Secondary|U p/c at Baseline and Weeks 3, 4, 8, 12, 24, 30, 36, and 52 Following Conversion to SRL|U p/c was measured in milligrams per milligram (mg/mg). The baseline U p/c values were the last values of the pre-SRL conversion period.|Baseline and 3, 4, 8, 12, 24, 30, 36, and 52 weeks after conversion|mITT population; n (number) = number of participants assessed for the specified parameter at a given visit; only participants with nonmissing records of U p/c were included in the analysis. Includes measures collected from On-Therapy and Off-Therapy Periods.||mg/mg||Standard Deviation|Mean
136612|NCT00502242|Secondary|Percentage of Participants With Both U Alb/c <0.5 and U p/c <0.5 at 24 and 52 Weeks Following Conversion to SRL|The U alb/c and U p/c must have been collected on the same day to be counted as the numerator.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.||percentage of participants|||Number
136613|NCT00502242|Secondary|Percentage of Participants With Urinary Albumin to Creatinine Ratio (U Alb/c) <0.5 at 24 and 52 Weeks Following Conversion to SRL|Spot urine sample of albumin and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.||percentage of participants|||Number
136614|NCT00502242|Secondary|Percentage of Participants With U p/c <0.5 at 24 and 52 Weeks Following Conversion to Sirolimus|Spot urine sample of protein and creatinine concentrations were obtained during the pre-SRL conversion period and after conversion.|24 weeks and 52 weeks after conversion|mITT population; includes assessments from On-Therapy and Off-Therapy Periods.||percentage of participants|||Number
136615|NCT00502242|Secondary|Percentage of Participants Who Had a Dose Escalation in Randomized Test Article (Ramipril or Placebo) by 52 Weeks Following Conversion to SRL|Defined as the time from the first dose of SRL administration to the first dose escalation of randomized test article (ramipril or placebo; in weeks), or censored on the day that a participant stopped the combination of SRL and randomized test article (ramipril or placebo) if the participants did not experience any ramipril/placebo dose escalation following conversion to SRL. Dose-escalation was defined as an increase in total daily dose of ramipril/placebo compared to Day 1 post conversion. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|mITT population||percentage of participants||95% Confidence Interval|Number
136663|NCT00501046|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function and (QOL: Exploratory)||approximately 42 months||||||
136664|NCT00501046|Primary|Safety and Tolerability||approximately 42 months||||||
136616|NCT00502242|Primary|Percentage of Participants Who Had Initiated Losartan Therapy at 52 Weeks Following Conversion to SRL|The event for each participant was defined as the initiation of losartan while on SRL and ramipril/placebo combination therapy. Participants who started losartan prior to SRL administration were not counted as events. Percentage was estimated using Kaplan-Meier method for time to event data.|From Day 1 of SRL conversion to 52 weeks after conversion|Modified Intent to Treat (mITT) population: all participants in the safety population who took at least one dose of SRL.||percentage of participants||95% Confidence Interval|Number
136617|NCT00502216|Secondary|Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline||11 weeks||||||
136618|NCT00502216|Secondary|Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment||4 weeks||||||
136619|NCT00502216|Primary|Weight Gain in Treatment Completers||baseline and 12 weeks|Subpopulation of participants who reported quitting smoking||Pounds||Standard Deviation|Mean
136620|NCT00502203|Primary|Number of Participants With Overall Response|Overall response rate including complete (CR) and partial responses (PR) with measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) assessment. CR: Disappearance of all target and non-target lesions; no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. PR: At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; no unequivocal progression of non-target lesions and no new lesions. Documentation by 2 disease assessments at least 4 weeks apart is required.|24 Months|Thirteen participants had measurable disease therefore evaluable for a complete or partial response.||participants|||Number
136621|NCT00501345|Primary|Participants With 7 Days Observation Without Severe Bleeding|Blood samples collected at baseline before or after aspirin is given and at 24 hours, 72 hours and 7 days after treatment has been initiated for those that remain in the study after the first 24 hours.|7 Days|The baseline Thromboelastogram showed normal platelet function in all patients and no evidence of heparin induced thrombocytopenia (HIT). No further analysis was done as study was terminated due to lack of accrual.|||||
136622|NCT00501293|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|6 months|Safety Population||Participants|||Number
136623|NCT00501293|Primary|Weight||Baseline and 6 months|Safety population||lb||Standard Deviation|Mean
136624|NCT00501293|Primary|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|6 months|Safety Population||Participants|||Number
136625|NCT00501293|Primary|Electrocardiogram Results (QTcF Interval)|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and 6 months|Safety Population||msec||Standard Deviation|Mean
136626|NCT00501293|Primary|Pulse Rate||Baseline and 6 months|Safety population||beats per minute||Standard Deviation|Mean
136627|NCT00501293|Primary|Diastolic Blood Pressure||Baseline and 6 months|Safety population||mmHg||Standard Deviation|Mean
136628|NCT00501293|Primary|Systolic Blood Pressure||Baseline and 6 months|Safety population defined as all subjects that received at least one dose of MTS.||mmHg||Standard Deviation|Mean
136629|NCT00501293|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at 6 Months|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 6 months|ITT. Not all subjects in the ITT population completed a YQOL-R.||Units on a scale||Standard Deviation|Mean
136630|NCT00501293|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores.|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT||Participants|||Number
136631|NCT00501293|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 months|ITT||Participants|||Number
136632|NCT00501293|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) at 6 Months|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 months|ITT||Units on a scale||Standard Deviation|Mean
136633|NCT00501293|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Scores at 6 Months|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 months|Intent-to-treat (ITT) defined as subjects who were enrolled and received at least one dose of MTS and had at least one assessment of the primary efficacy endpoint.||Units on a scale||Standard Deviation|Mean
136634|NCT00501228|Primary|Number of Donor Derived Cells After G-CSF Therapy|In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.|Baseline + 8 Weeks post transplant|No analysis was done. Only one eligible patient was able to complete treatment.|||||
136665|NCT00501046|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)||participants|||Number
139942|NCT00468819|Primary|Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.|From injection of Gadobutrol up to 8 hours after injection.|Final pharmacokinetics (PK) analysis set||L/h||Inter-Quartile Range|Median
136635|NCT00501995|Secondary|Secondary Endpoint Was Changes in the Total Severity Score (Composite) and Measures of Severity in Each Specific Organ (Organ Specific Measures).|The total severity score is comprised of results from the Health Assessment Questionnaire-Disability Index (HAQ-DI) a 48 item questionnaire assessing ability to perform activities of daily living, use of assistive devises and a 6 item analog scale of pain severity from 0 cm (no pain) to 14.3 cm (very severe pain). The physician global assessment (PGA) which is a visual analogue scale from 0 to 100 on which the physician rates the patient's disease severity based on their observations. The score also included the Forced Vital Capacity (FVC) which is a measure of lung capacity and Diffusing Capacity (DLCO) which measures the ability of the lung to absorb oxygen accross the membrances in the alveoli. The FVC and DLCO are measured through pulmonary function testing. The predicted lung volumes were referenced from NHANES/Hanikson et al and for DLCO predicteds were from Knudson. Pre and post study intervention scores were compared.|0-24 months||04/2017||||
136636|NCT00501995|Primary|The Primary Endpoint Will be an Improvement in the Modified Rodnan Skin Score.|The modified Rodnan skin score is the accepted clinical measure of scleroderma skin activity. The investigator will assess the thickening of the skin using the modified Rodnan skin score through simple palpation on 17 different body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Skin thickness is assessed on a scale of 0-3; 0 representing normal skin and 3 being severe thickening. The sum of the individual scores can range from 0-51; 0 (normal) to 51 (severe thickening in all 17 areas) A 25% improvement in the modified Rodnan Skin score will be considered significant at any time point in the study. Modified Rodnan Skin Score was evaluated at months 0,1,3,6,12 and 24 months.|0 to 24 months|Patient 4 died during the early phase of the study and longitudinal assessment of his skin score was not determined.||percent improvement from baseline||Full Range|Mean
136637|NCT00501969|Secondary|Mean Epworth Sleepiness Scale Score During the Open-label Extension|The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.|Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.||Score on a scale||Standard Deviation|Mean
136638|NCT00501969|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).||Subjects|||Number
136639|NCT00501969|Primary|Number of Subjects With at Least One Adverse Event During This Open-label Extension Study|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|five years|Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).||Subjects|||Number
136640|NCT00501943|Secondary|Changes in Normalized Grey Matter Volume|The baseline data of grey matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12 and Month-24|||percent change per year||95% Confidence Interval|Mean
136641|NCT00501943|Secondary|Changes in Symbol Digit Modality Test (SDMT)|Baseline SDMT data were compared to SDMT data collected during the timepoints. A simple substitution task, the SDMT gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
136642|NCT00501943|Secondary|Changes in Peripapillary Retinal Nerve Fiber Layer Thickness (RNFL)|Baseline RNFL data is compared to the RNFL data collected during the timepoint, and the changes in RNFL is measured using optical coherence tomography (OCT).|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
136643|NCT00501943|Secondary|Changes in MS Functional Composite (MSFC)|Baseline MSFC data is compared to MSFC data collected during the timepoints. The MSFC is a three-part, standardized, quantitative, assessment instrument that measures the clinical dimensions of leg function, arm/hand function and cognitive function and the components include Timed 25-Foot walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test.|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
136644|NCT00501943|Secondary|Changes in Normalized White Matter Volumes (nWMV)|The baseline data of white matter volume obtained from the MRI images is compared to data obtained at time points using SIENA (Structural Image Evaluation using Normalization of Atrophy) and SIENAX|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|||percent change per year||95% Confidence Interval|Mean
136645|NCT00501943|Primary|MRI Parameter- Percent Brain Volume Change for 2 Years|Baseline MRI is compared to MRI images collected during subsequent timepoints. The percent brain volume change is measured using SIENAX (Structural Image Evaluation using Normalization of Atrophy-X)|Baseline, Month-3, Month-6, Month-12, Month-18 and Month-24|Multivariate regression model was used as the statistical method of analysis for the study. So data from patients who have not completed the study are also used for statistical analysis.||percent change per year||95% Confidence Interval|Mean
136646|NCT00501891|Secondary|Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity|Number of participants experiencing a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity|27 months|Intent to treat||participants|||Number
136647|NCT00501891|Secondary|Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage|Number of participants experiencing a Central Nervous System (CNS) hemorrhage or systemic hemorrhage|27 months|Intent to treat||participants|||Number
136666|NCT00501007|Secondary|Persistence as a Prospective Predictor of Smoking Cessation|Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables.|6 months|||Odds ratio||95% Confidence Interval|Number
136648|NCT00501891|Secondary|Response Rate|The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|27 months|Intent to treat||Number of participants|||Number
136649|NCT00501891|Primary|6-Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. [Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).]|6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
136650|NCT00501852|Secondary|Least Squares Means of FEV1 (L) at Day 1, by Timepoint|FEV1 was measured at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23 hours and 15 minutes, and 23 hours and 45 minutes post dose.|Day 1|||Liters||Standard Error|Least Squares Mean
136651|NCT00501852|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing.|Day 7|Modified Intent-to-Treat (mITT) population. The modified intent-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they received.||Liters||Standard Error|Least Squares Mean
136652|NCT00501644|Primary|Number of Patients With Response|Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as > = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by >50%, provided target lesion size did not increase by >20% on imaging, and PD as >20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or > new lesions.|Follow up CT scans after every 3 courses of treatment and following completion of all treatments.|Analysis per protocol. Of 59 participants enrolled, five (5) were not evaluable.||Participants|||Number
136653|NCT00501631|Secondary|Longer-term Safety of VIVITROL|Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.|up to 1 year||||||
136654|NCT00501631|Primary|Cumulative Percentage of Participants by Heavy Drinking Rate|"Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A heavy drinking day was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell & Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary)."|up to 12 weeks|The primary endpoint is based on percentage rate of heavy drinking days during the double-blind treatment period as per protocol.||percentage of participants|||Number
136655|NCT00501592|Secondary|Hepatocellular Function|Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function|baseline and 6 weeks|||U/L||Standard Deviation|Mean
136656|NCT00501592|Primary|Insulin Resistance and Glucose Homeostasis|The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).|baseline and 6 weeks|||mg/kg/min||Standard Deviation|Mean
136657|NCT00501085|Secondary|Subject Reported Sleepiness (Epworth Sleepiness Scale)|The Epworth Sleepiness Scale (ESS) is a questionnaire used to determine a subject’s level of daytime sleepiness. Subjects rate his or her chances of dozing off in different situations, which are combined into a total ESS score that can vary between zero (low level of daytime sleepiness) and 24 (high level of daytime sleepiness).|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.||units on a scale||Standard Deviation|Mean
136658|NCT00501085|Secondary|Subject Reported Quality of Life|Quality of Life was assessed using the Obesity and Weight-Loss Quality of Life Questionnaire (OWL-QOL-17). The OWL-QOL-17 is a survey of 17 questions, that rates quality of life on a scale of 0 (better) to 102 (lower).|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.||units on a scale||Standard Deviation|Mean
136659|NCT00501085|Secondary|Subject Reported Satiety|Subjects rated their level of hunger, satiety after meals, and desire to eat at all follow-up visits. Level of hunger was rated using a 6-point scale: 0 = not hungry at all to 5 = as hungry as I have ever felt. Satiety after meals was rated using a 6-point scale: 0 = not at all full to 5 = as full as I have ever felt. Desire to eat was rated using a 6-point scale: 0 = no desire at all to 5 = extremely strong desire.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.||units on a scale||Standard Deviation|Mean
136660|NCT00501085|Secondary|Subject BMI From Baseline to 5 Years Post LAP-BAND Implantation|Subjects' Body Mass Index (BMI) was recorded at each follow-up visit for the 5 years after LAP-BAND implantation.|Baseline to 5 years|The analysis population is defined as all subjects treated with the LAP-BAND System.||kg/m2||Standard Deviation|Mean
136661|NCT00501085|Primary|Change in Percent Excess Weight|Subjects' Percent Excess Weight Loss (%EWL) from baseline over the 5 year period post LAP-BAND implantation was measured. Excess Weight = Baseline weight - Ideal weight, where ideal weight is based on a BMI of 25 kg/m2.|Baseline to 5 Years|The analysis population is defined as all subjects treated with the LAP-BAND System.||percentage of excess weight lost||Standard Deviation|Mean
136662|NCT00501046|Secondary|Vitamins and Folate Levels||approximately 42 months||||||
136668|NCT00500760|Secondary|Percentage of Participants With a Complete Response at 6 Months|Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.|6 months|Evaluable for Central Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
136669|NCT00500760|Secondary|Percentage of Participants With an Objective Response at 6 Months|"Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months.~Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions."|6 months|Evaluable for Central Tumor Response Analysis Set: the subset of participants in the Efficacy Analysis Set with at least one bi-dimensionally measurable lesion at baseline using a modified version of the WHO criteria per blinded central review.||percentage of participants||95% Confidence Interval|Number
136670|NCT00500760|Secondary|Overall Survival|Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.|From first dose date up to 37 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
136671|NCT00500760|Secondary|Progression-Free Survival|"Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death.~Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions.~Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date."|From first dose date to 37 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
136672|NCT00500760|Secondary|Duration of Local-regional Control|Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.|From first dose up to 37 months|Efficacy Analysis Set||months||95% Confidence Interval|Median
136673|NCT00500760|Secondary|Local Regional Control Rate at 6 Months and 12 Months|Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|6 months and 12 months|Efficacy Analysis Set||proportion of paticipants||95% Confidence Interval|Number
136674|NCT00500760|Primary|Local Regional Control Rate at 2 Years|In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.|2 years|Efficacy Analysis Set (all randomized participants who received at least 1 dose of protocol-specified treatment according to treatment randomization regardless of treatment received.)||proportion of paticipants||95% Confidence Interval|Number
136675|NCT00500682|Secondary|Vitamins and Folate Levels||approximately 42 months||||||
136676|NCT00500682|Secondary|The Development of a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death), Other Measures of Renal Function||approximately 42 months||||||
136677|NCT00500682|Primary|Safety and Tolerability||approximately 42 months||||||
136678|NCT00500682|Primary|Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.||Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint|ITT (censored at last contact)||participants|||Number
136679|NCT00500656|Secondary|Time to Almost Complete Symptom Relief|Almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least three consecutive measurements for all symptoms.|48 hours|||Hours||Inter-Quartile Range|Median
136680|NCT00500656|Primary|Time to Onset of Symptom Relief.|"The primary efficacy endpoint was Time to onset of symptom relief (TOSR) following treatment with either icatibant or tranexamic acid. The median time to onset of symptom relief for the icatibant group was compared to the the median time to onset of symptom relief for the tranexamic acid group.~TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the three primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.~The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|2 days|||Hours||Inter-Quartile Range|Median
136681|NCT00500578|Primary|Occurrences of Pneumonia|Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.|6 Years|The analysis was carried out per protocol. All patients enrolled were included in the final analysis except one patient who was a screen failure.||Participants|||Number
136700|NCT00500370|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
136682|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).|Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.||participants|||Number
136683|NCT00500539|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period|The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.|24 weeks treatment period + 4 weeks for following up participants|The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.||participants|||Number
136684|NCT00500539|Primary|The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period|An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.|16 weeks after last dose|The Safety Population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. The analysis was done on total number of patients who had follow-up HAHA sample taken.||participants|||Number
136685|NCT00500448|Primary|Change From Baseline in Quadriceps Strength at 12 Weeks||Baseline and 12 weeks following the intervention|||Nm/kg||95% Confidence Interval|Mean
136686|NCT00500448|Secondary|Change From Baseline in WOMAC Pain Score at 12 Weeks|WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)|Baseline and 12 weeks following intervention|||units on a scale||95% Confidence Interval|Mean
136687|NCT00500448|Secondary|Change From Baseline in Timed Walking Speed at 12 Weeks||Baseline and 12 weeks post-intervention|||m/s||95% Confidence Interval|Mean
136688|NCT00500448|Secondary|Change From Baseline in WOMAC Disability Score at 12 Weeks|Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)|baseline and 12 weeks post-intervention|||units on a scale||95% Confidence Interval|Mean
136689|NCT00500448|Primary|Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks|Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus|Baseline and 12 weeks post-intervention|||unitless||95% Confidence Interval|Mean
136690|NCT00500370|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)|24 weeks|Intent to Treat population||percent||Standard Error|Least Squares Mean
136691|NCT00500370|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)|24 weeks|Intent to Treat population||pmol/L||Standard Error|Least Squares Mean
136692|NCT00500370|Secondary|Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)|Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24|24 weeks|Intent to Treat population||Participants|||Number
136693|NCT00500370|Secondary|Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis|Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24|24 weeks|Intent to Treat population||Participants|||Number
136694|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)|Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity.|24 weeks|Intent to Treat population; Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
136695|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)|Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function.|24 weeks|Intent to Treat population; Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
136696|NCT00500370|Secondary|Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)|Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||(mmol*hr)/L||Standard Error|Least Squares Mean
136697|NCT00500370|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0)|24 weeks|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
136698|NCT00500370|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
136699|NCT00500370|Secondary|Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)|Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
136701|NCT00500370|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)|24 weeks|Intent to Treat population; Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
136702|NCT00500370|Secondary|Percentage of Patients Experiencing >=5% Weight Loss|Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%)|24 weeks|Intent to Treat population; Last Observation Carried Forward||percentage of patients|||Number
136703|NCT00500370|Secondary|Change in Waist-to-hip Ratio|Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint.|24 weeks|Intent to Treat population||Ratio||Standard Error|Least Squares Mean
136704|NCT00500370|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)|24 weeks|Intent to Treat population||kg/m^2||Standard Error|Least Squares Mean
136705|NCT00500370|Primary|Change in Body Weight|Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)|24 weeks|Intent to Treat population||kg||Standard Error|Least Squares Mean
136706|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
136707|NCT00500357|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Pneumococcal IgG GMCs measured as micrograms per milliliter (mcg/mL) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMCs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody concentration for the specified serotype.||geometric mean concentration (mcg/mL)||95% Confidence Interval|Geometric Mean
136708|NCT00500357|Secondary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC / 23vPS (Vaccination 2)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 1 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population; N=number of participants with a determinate antibody titer for the specified serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
136709|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New muscle pain, Aggravated muscle pain, New joint pain, and Aggravated joint pain.|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population; N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.||percentage of participants|||Number
136710|NCT00500357|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC / 23vPS / 13vPnC (Vaccination 3)|Local reactions reported using electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (> 10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move shoulder).|Days 1 through 14 / Year 2 (Follow-up study/NCT00500357)|Safety population included all participants who received the vaccine sequence 13vPnC / 23vPS / 13vPnC. N=number of participants with reactogenicity events (reported Yes for at least 1 day or No for all days); (n)=number of participants with known values for 13vPnC / 23vPS / 13vPnC (Vax 3). Participants may be represented in more than 1 category.||percentage of participants|||Number
136711|NCT00500357|Primary|Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes 1 Month After 13vPnC / 23vPS / 13vPnC (Vaccination 3) Versus 1 Month After 13vPnC (Vaccination 1)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Month 1 / Year 0 (Core study/NCT00269672), Month 1 / Year 2 (Follow-up study/NCT00500357)|Evaluable Immunogenicity population includes participants from the evaluable immunogenicity population for Vax 1 and Vax 2 in the core study/NCT00269672, received 13vPnC in follow-up study/NCT00500357, and had at least 1 assay result in the follow-up study. N=number of participants with a determinate antibody titer for the specified serotype.||geometric mean titer||95% Confidence Interval|Geometric Mean
136743|NCT00499863|Secondary|Dermal Response Scale (DRS) Scores|Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|up to 7 weeks|Safety population which included all randomized subjects that received at least one dose of MTS or PTS.||scores on a scale||Standard Deviation|Mean
136712|NCT00500318|Secondary|Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio|Ratio of trough Inspiratory Capacity verses Total Lung Capacity.|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||ratio||Standard Error|Least Squares Mean
136713|NCT00500318|Secondary|Functional Residual Capacity (FRC)|Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||L||Standard Error|Least Squares Mean
136714|NCT00500318|Secondary|Trough Inspiratory Capacity (IC)|Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).|Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||L||Standard Error|Least Squares Mean
136715|NCT00500318|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).|Change from baseline (Visit 4) at Week 6 (Visit 6)|The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).||L||Standard Error|Least Squares Mean
136716|NCT00500318|Primary|Change From Baseline in Exercise Endurance Time (ET)|Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.|From baseline Week 0 (Visit 4) to Week 6 (Visit 6)|Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available.||Seconds||Standard Error|Least Squares Mean
136717|NCT00500292|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)|||Participants|||Number
136718|NCT00500266|Primary|Percentage of Participants Taking Pain or Antipyretic Medication|Use of pain or antipyretic medication was collected by the participants using an electronic diary.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.||Percentage of Participants||95% Confidence Interval|Number
136719|NCT00500266|Primary|Percentage of Participants With Pre-specified Systemic Events|Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as “yes” for at least 1 day or as “no” for all days.||Percentage of Participants||95% Confidence Interval|Number
136720|NCT00500266|Primary|Percentage of Participants With Pre-specified Local Reactions|Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.|Days 1 through 14|Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting “yes” for at least 1 day or “no” for all days.||Percentage of Participants||95% Confidence Interval|Number
136721|NCT00500240|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of complete remission and the date of relapse detection or death. Complete Remission (CR) defined as granulocyte count >1.0 × 10^9/L, platelet count >100 × 10^9/L, no abnormal peripheral blasts, and <5% blasts in normocellular or hypercellular bone marrow.|Date of complete remission to disease progression, assessed for approximately 6 years|There were 51 evaluable participants.||Months||Full Range|Median
136722|NCT00500240|Primary|Overall Survival|Overall survival (OS) defined as the interval between the date of randomization and the date of death. Calculation of period was from baseline (date of randomization) to the death or last follow-up.|Baseline (date of randomization) to date of death or last follow-up (weekly during treatment then every 2 months post study treatment) up to 6 years|||Months|Participants|Full Range|Median
136723|NCT00500240|Primary|1-Year Overall Survival Rate|The overall survival rate defined as percentage of participants in each treatment group who are still alive at 12 months.|1 year|There were 51 evaluable participants.||percentage of participants||95% Confidence Interval|Number
136744|NCT00499863|Other Pre-specified|Post Sleep Questionnaire (PSQ) Quality of Sleep|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 7 weeks|Safety population (Note: not everyone in the safety population completed a sleep questionnaire)||Participants|||Number
136724|NCT00500149|Secondary|Duration of Effect of Vyvanse|Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on intention-to-treat (ITT) population.||scores on a scale||Standard Error|Least Squares Mean
136725|NCT00500149|Primary|Onset of Effect of Vyvanse|The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).|Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.|Analysis on the intention-to-treat (ITT) population.||scores on a scale||Standard Error|Least Squares Mean
136726|NCT00500110|Primary|Number of Participants Achieving Pathological Complete Response|Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.|Every 3 months for 1 year, then every 6 months until disease progression or death|Analysis was per protocol.||participants|||Number
136727|NCT00500071|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks|Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Baseline and 7 weeks|ITT||Units on a scale||Standard Deviation|Mean
136728|NCT00500071|Secondary|Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks|Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.|Baseline and 7 weeks|ITT||Units on a scale||Standard Deviation|Mean
136729|NCT00500071|Secondary|Number of Participants With Improvement onParent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|7 weeks|ITT||Participants|||Number
136730|NCT00500071|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 or 2 on the scale.|7 weeks|ITT||Participants|||Number
136731|NCT00500071|Primary|Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 7 weeks|Intent-to-treat (ITT). ITT population defined as all subjects who took at least one dose of drug and had at least one ADHD-RS-IV total score available.||Units on a scale||Standard Error|Mean
136732|NCT00500071|Secondary|Weekly Change From Baseline in Total ADHD-RS-IV Score|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks|ITT||Units on a scale||Standard Error|Mean
136733|NCT00499915|Secondary|Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.||2, 5, and 7-9 months post baseline||||||
136734|NCT00499915|Primary|Infants Living in Smoke-free Environments.|"Infants living in homes with a home smoking ban rule"|5 months post baseline|||participants|||Number
136735|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant DLI|Number of participants with response of molecular complete remission (mCR) to DLI as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 year|Only 8 participants having the post-transplant DLI out of the 41 participants treated were analyzed for this outcome.||Participants|||Number
136736|NCT00499889|Primary|Number of Participants in Complete Molecular Remission at 1 Year|Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials).|Baseline to 1 year|Analysis was per protocol. One patient did not receive treatment and was excluded from analysis.||participants|||Number
136737|NCT00499889|Secondary|Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy|Number of participants with response of molecular complete remission (mCR) to Imatinib Mesylate therapy as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests.|1 Year|Analysis was per protocol. Only 19 participants having the post transplant Imatinib Mesylate Therapy out of the 41 participants treated were analyzed for this outcome.||Participants|||Number
136738|NCT00499863|Secondary|Change From Baseline in Weight at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population||lbs||Standard Deviation|Mean
136739|NCT00499863|Secondary|Change From Baseline in Diastolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)|||mmHg||Standard Deviation|Mean
136740|NCT00499863|Secondary|Change From Baseline in Systolic Blood Pressure at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population||mmHg||Standard Deviation|Mean
136741|NCT00499863|Secondary|Change From Baseline in Pulse Rate at Endpoint||Baseline and endpoint (up to 7 weeks)|Safety population||bpm||Standard Deviation|Mean
136742|NCT00499863|Secondary|Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and endpoint (up to 7 weeks)|Safety population||msec||Standard Deviation|Mean
136745|NCT00499863|Secondary|Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint|The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often).|Baseline and endpoint (up to 7 weeks)|ITT||scores on a scale||Standard Error|Least Squares Mean
136746|NCT00499863|Secondary|Improvement in Parent Global Assessment (PGA) Score|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT||Participants|||Number
136747|NCT00499863|Secondary|Improvement in Clinical Global Impressions-Improvement (CGI-I) Score|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 7 weeks|ITT||Participants|||Number
136748|NCT00499863|Secondary|Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true).|Baseline and endpoint (up to 7 weeks)|ITT||scores on a scale||Standard Error|Least Squares Mean
136749|NCT00499863|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint|The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|baseline and endpoint (up to 7 weeks)|Intent-to-treat (ITT) which included all randomized subjects who received at least one dose of MTS or PTS, and had one Baseline and at least one post-Baseline assessment.||scores on a scale||Standard Error|Least Squares Mean
136750|NCT00499694|Secondary|Correlation of Urine NTX and Serum BSAP Levels With Time to Progression||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
136751|NCT00499694|Secondary|Changes in Levels of N-terminal Collagen Peptide (NTX) and Bone-specific Alkaline Phosphatase (BSAP)||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
136752|NCT00499694|Secondary|Overall Survival||Followed every 3 months after treatment is discontinued||||||
136753|NCT00499694|Secondary|Prostate-specific Antigen (PSA) Response Rate||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
136754|NCT00499694|Secondary|Toxicity||Day 1 of every cycle (35 days) and Day 15 of every cycle||||||
136755|NCT00499694|Primary|Time to Progression||Every 70 days|||months||90% Confidence Interval|Median
136756|NCT00499681|Primary|Number of Participants With a Pathological Complete Response|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|at 14 weeks|Participants who were available for measurement of response.||participants|||Number
136757|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 24 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|24 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.||participants|||Number
136758|NCT00499603|Secondary|Participant Responses Per Treatment Arm at 12 Weeks|Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.|12 weeks|Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.||participants|||Number
136759|NCT00499603|Primary|Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours|Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present.|48 hours after start of treatment|Participants were randomly assigned 1:1 to receive T-FEC or TR-FEC using a balanced block design stratified by disease stage and menopausal status. One participant in Arm 2 started treatment but had untolerable side effects and was taken off the study and thus was considered inevaluable.||participants|||Number
136760|NCT00499590|Secondary|Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision||Week 60|Zero participants analyzed due to early termination of the study.|||||
136761|NCT00499590|Primary|Visual Acuity|avoidance of 3 or more lines of vision loss|week 60|Zero participants analyzed due to early termination of the study.|||||
136762|NCT00499486|Primary|Severity of Adverse Events as Assessed by NCI CTCAE v3.0||6 months|||percentage of Adverse Events|||Number
142082|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
136763|NCT00499486|Primary|Response Rate (Complete, Partial Response and Stable Disease) as Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Response for Stable disease was assessed at 2 months and for complete and partial response at 6 months.|response at 2 and 6 months|||participants|||Number
136764|NCT00499486|Primary|Percentage of Patients With Overall Survival at 6 Months||6- month survival rate (6mSR)|||% of participants|||Number
136765|NCT00499473|Secondary|Overall Survival||up to 12 months|||months||Full Range|Median
136766|NCT00499473|Secondary|Percentage of Patients Progression Free at 12 Months||At 12 months after the start of treatment|||percent of patients|||Number
136767|NCT00499473|Secondary|Confirmed Objective Response (Complete Response[CR] or Partial Response [PR])|Confirmatory scans should also be obtained within 4 to 6 weeks following initial documentation of objective response. Confidence intervals for the true proportion will be calculated using the exact binomial method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 weeks|Only 21 patients were evaluable for response||patients|||Number
136768|NCT00499473|Primary|Dose Resulting in Steady-state Trough|Average of pre-dose values of sunitinib + SU12662 plasma concentrations equivalent to that observed in patients not receiving EIAC based on pharmacokinetic modeling.|At baseline (day 8) and days 15, 22, and 23|Not determined due to early termination of the study due to lack of efficacy|||||
136769|NCT00499473|Primary|Maximum Tolerable Dose Based on Dose-limiting Toxicity of Sunitinib in Patients Receiving EIAC (Stratum 2)|Maximum tolerable dose of sunitinib in patients receiving treatment with EIAC agents using dose escalation based on the steady-state trough sunitinib + SU12662 plasma concentrations on day 14 observed in patients treated in stratum 1. Six patients will be treated in each dose cohort with up to 12 patients being treated at the maximum tolerable dose for a total of 18-24 patients with gliomas receiving EIAC.|From the time of first treatment with sunitinib until completion of treatment, assessed up to 30 days|MTD in Stratum 2 not determined due to lack of efficacy in Stratum 1|||||
136770|NCT00499473|Primary|Progression-free Survival at 6 Months (Stratum 1)|Number of patients with Progression-free Survival at 6 months for Stratum 1|From time to registration to up to 6 months|Only 21 patients were evaluable for PFS||patients|||Number
136771|NCT00499447|Secondary|Rate of Acute and Late Treatment-related Toxicity (Per CTCAE, v3.0) Related to Specific Symptoms||two years||||||
136772|NCT00499447|Primary|Two Year Progression Free Survival Rate|the number of patients surviving progression-free at two years.|2 years|||participants|||Number
136773|NCT00499408|Secondary|Changes in PSA Doubling Time||up to one year||||||
136774|NCT00499408|Secondary|Changes in PSA Slope||up to one year||||||
136775|NCT00499408|Primary|Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment||up to one year|||participants|||Number
136776|NCT00499369|Secondary|Toxicity|Number of patients with Grade 3 through 5 adverse events that are related to study drug. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
136777|NCT00499369|Primary|Progression-free Survival (PFS)|PFS is measured from date of registration to first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 5 years|All eligible patients are included in this analysis.||months||95% Confidence Interval|Median
136778|NCT00499369|Secondary|Objective Tumor Response||Up to 5 years|No participants were analyzed due to limited accrual.|||||
136779|NCT00499369|Secondary|Overall Survival|Time to death is from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 5 years|No participants were analyzed due to limited accrual.|||||
136780|NCT00499343|Primary|CD34+ Cells/kg in Blood Stem Cells|After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.|The process of stem cell collections take about 4 hours, 1-6 sessions may be needed.|||CD34+ cells/kg||Full Range|Median
136781|NCT00499252|Secondary|Overall Survival||from entry into the study to death or the date of last contact.|Eligible and Treated Patients||months||95% Confidence Interval|Median
136782|NCT00499252|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|from study entry until disease progression, death or date of last contact.|Eligible and Treated Patients||months||95% Confidence Interval|Median
136783|NCT00499252|Primary|Frequency and Severity of Observed Adverse Effects|Refer to Adverse Events (AE) tables.|Every cycle during treatment||||||
136805|NCT00498940|Primary|Thermal Dilution Cardiac Index (CI) Measured in the Intensive Care Unit (ICU).|Cardiac output (CO) 12-24 hours after bypass is measured five times and averaged. CO is then converted to CI, after division by the patient's body surface area.|24 hours|||L/min/m^2||Standard Error|Mean
136806|NCT00498927|Secondary|Overall Survival|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.|2 years|Glioblastoma patients||months||95% Confidence Interval|Median
136784|NCT00499252|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels|Eligible and Treated Patients||Percentage of participants||95% Confidence Interval|Number
136785|NCT00499122|Secondary|To Correlate Serum Protein Glutathionylation With Clinical and Pathologic Responses||4 years||||||
136786|NCT00499122|Secondary|To Define the Safety Profiles of Preoperative Administration of NOV-002 in Combination With Doxorubicin, Cyclophosphamide Followed by Docetaxel.||4 years||||||
136787|NCT00499122|Primary|Percentage of Participants Achieving Pathologic Complete Response|Pathologic complete response (pCR) is defined according to Hankoop et al [41] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.|4 years|||percentage of participants||95% Confidence Interval|Number
136788|NCT00499109|Secondary|Response Rate (RR)|Number of participants per response category. Response to treatment was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months|All evaluable participants||participants|||Number
136789|NCT00499109|Secondary|Overall Survival (OS)|OS at 12 months, determined from the date of randomization. The time interval from randomization to the date of death was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the overall survival.|12 months|All participants||estimated percentage of participants||95% Confidence Interval|Number
136790|NCT00499109|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months.|6 months|All participants||estimated percentage of participants||95% Confidence Interval|Number
136791|NCT00499096|Secondary|Body Mass Index (BMI)|Body mass index (BMI) is reported in kilograms divided by meters squared (kg/m^2) with a normal (healthy) range of 18-24, in which >=25 is considered overweight, and >=30 is the definition of obesity|24 months|||kg/m^2||Standard Deviation|Mean
136792|NCT00499096|Secondary|Disability Based on WHO-DAS Score|Disability based on the WHO Disability Assessment Scale (WHO-DAS); range = 0-24, higher score equals greater disability|24 months|||units on a scale||Standard Deviation|Mean
136793|NCT00499096|Secondary|Depressive Symptom Score|Depressive symptoms based on the Internal State Scale (Range: 0-200, higher score = more severe symptoms)|24 months|||units on a scale||Standard Deviation|Mean
136794|NCT00499096|Primary|Physical Health-related Quality of Life Score|Physical health-related quality of life is based on the Short Form (SF)-12 survey physical health component (PCS) score- which ranges from 0 to 50, with higher scores indicating higher quality of life|24 months|||units on a scale||Standard Deviation|Mean
136795|NCT00499096|Primary|Total Cholesterol|Total cholesterol in mg/dl- lower is better|24 months|||mg/dL||Standard Deviation|Mean
136796|NCT00499096|Secondary|Manic Symptoms|Manic symptoms based on the Internal State Scale (range is 0-500; higher score indicates more severe symptoms)|24 months|||units on a scale||Standard Deviation|Mean
136797|NCT00499096|Primary|Systolic and Diastolic Blood Pressure (SBP, DBP)|24-month systolic and diastolic blood pressure (mm/Hg): lower is better|24 months|||mm/Hg||Standard Deviation|Mean
136798|NCT00499031|Secondary|Duration of Overall Survival||From study entry to death or the date of last contact, up to 5 years||||||
136799|NCT00499031|Secondary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
136800|NCT00499031|Secondary|Duration of Objective Response Rate||Up to 5 years||||||
136801|NCT00499031|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, up to 5 years||||||
136802|NCT00499031|Primary|Objective Tumor Response Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|every other cycle for the first 6 months; then every 3 months x 2; then every 6 months|Total number of eligible and evaluable participants||participants|||Number
136803|NCT00499031|Primary|Progression-free Survival Greater Than 6 Months||At 6 months|Total number of eligible and evaluable participants||participants|||Number
136804|NCT00498940|Secondary|Secondary End Points Include Incidence of Arrhythmias, Inotropic Support, Urine Output, Weight Gain, Morbidity, Mortality, and ICU Costs.||30 days after surgery||||||
148574|NCT00399542|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
136807|NCT00498927|Primary|Progression-free Survival (PFS) Rate at 6 Months|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 6 months|Glioblastoma patients||percentage of participants|||Number
136808|NCT00498797|Secondary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)|||Participants|||Number
136809|NCT00498797|Primary|Prostate Specific Antigen (PSA) Response|Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response|PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline|||Participants|||Number
136810|NCT00498706|Primary|Depression, as Assessed by Hamilton Depression Rating Scale(Ham-D)|Ham-D indicates Hamilton Depression Rating Scale,range is 0 to 52. A score of 0 means the best outcome with no depression symptoms reported, and a score of 52 is the worse outcome with highest level of depression reported. A difference of 3 points on the Hamilton scale has been identified as clinically significant.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up|||units on a scale||Full Range|Mean
136811|NCT00498706|Primary|Patient Health Questionnaire (PHQ)-9|Measures depression on a 9 - item scale. Scores range from 0-27, with 0 being no symptoms. A difference of 5 or more points on the PHQ-9 is considered a clinically meaningful response to treatment.|Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6 post-treatment follow-up|||units on a scale||Full Range|Mean
136812|NCT00498706|Secondary|Health-related Quality of Life (SF-36V), Patient Satisfaction (Satisfaction Index - Mental Health), and Therapeutic Alliance (Working Alliance Inventory - Short Form)||Measured at baseline; Weeks 4, 9, 14, and 18; and Months 3, 6, 9, and 12 of follow-up||||||
136813|NCT00498706|Primary|Number of Participants Who Dropped Out of Therapy|"Using the number of therapy sessions attended, we categorized patients into:~those who discontinued treatment before session 18, and those who completed session 18.~those who discontinued before Session 5, and those who continued."|Post treatment, up to 18 weeks|||participants|||Number
136814|NCT00498706|Primary|Attrition (Number of Therapy Sessions Attended)|Number of therapy sessions attended was collected. At the end of treatment, the total number of sessions attended by each patient was collected.|Post treatment, up to 18 weeks|A randomized controlled trial of 325 Chicago area primary care patients with major depressive disorder, recruited from November 1007 to December 2010.||Number of Sessions|Participants|Standard Deviation|Mean
136815|NCT00498628|Secondary|Quality of Life Score|Quality of Life SF - 12|Week 12||||||
136816|NCT00498628|Secondary|Sleep Quality Score|Pittsburgh Sleep Quality Index|Weeks 4, 8 and 12||||||
136817|NCT00498628|Secondary|Anxiety Score|HAM-A|Weeks 4, 6, 8, 10 and 12||||||
136818|NCT00498628|Secondary|Depression Score|MADRS|Week 4, 6, 8, 10, and 12||||||
136819|NCT00498628|Secondary|Craving Score|PACS|Week 4, 6, 8, 10, 12||||||
136820|NCT00498628|Secondary|Drinking Consequences Score|DrInc Score|Weeks 6 and 12||||||
136821|NCT00498628|Secondary|Percent Subjects With no Heavy Drinking Day||3-11||||||
136822|NCT00498628|Secondary|Percent Subjects Abstinent||3-11||||||
136823|NCT00498628|Secondary|Percent Very Heavy Drinking Day||3-11||||||
136824|NCT00498628|Secondary|Drinks Per Day||3-11||||||
136825|NCT00498628|Secondary|Drinks Per Drinking Day||3-11||||||
136826|NCT00498628|Secondary|Percent Days Abstinent||3-11||||||
136827|NCT00498628|Primary|Percent Heavy Drinking Days|A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.|Weeks 3 - 11|Intention to Treat||percentage of heavy drinking days||Standard Error|Least Squares Mean
136828|NCT00498615|Primary|Time to Recover to 70% of Fall in the Baseline Skin Temperature After Cold Challenge.|The time to recover 70% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes|||minutes||Standard Deviation|Mean
136829|NCT00498615|Secondary|The Blood Flow by Laser Doppler Scans of the Fingers|The measurement of the blood flow of participants prior to cold challenge 2 hours after receiving study.|Blood flow prior to cold challenge 2 hours after taking study drug|||perfusion units||Standard Deviation|Mean
136830|NCT00498615|Primary|The Time to Recover 50% of Fall in the Baseline Skin Temperature.|The time to recover 50% of the drop from baseline (prechallenge) skin temperature was derived for each subject for each cold challenge. After each of 3 study interventions received by each participant. Each participant received Fasudil 4o mg, 80 mg and placebo in a randomized sequence blinded to the participant and researchers.|within 60 minutes|||minutes||Standard Deviation|Mean
136831|NCT00498602|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104||||||
136832|NCT00498602|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
136865|NCT00498368|Secondary|Biochemical Marker Gd-Immunoglobulin A Subclass 1 (IgA1) at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.||U/100ng IgA||Standard Deviation|Mean
136833|NCT00498602|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
136834|NCT00498602|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose|The safety population included all randomized participants with documented use of at least one dose of study drug.||percentage of participants|||Number
136835|NCT00498550|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|This study utilized the 24 item BPRS. Each item is rated a 0 (not present) to 6 (severe) scale. The minimum score for this assessment is 0 and the maximum score is 144.|12 weeks|||BPRS Score||Standard Deviation|Mean
136836|NCT00498550|Primary|Days of Cannabis Use as Measured by the Timeline Followback||12 weeks||||||
136837|NCT00498485|Primary|Self Reported Assessment of Sleep|Subjects were asked to provide their input as to the quality of their sleep over the past week|Assessed at week 6|While data were collected, these data were never analyzed because the study was terminated prematurely by the sponsor and were lost when PI moved from UMDNJ to Beth Israel in NYC in 2008.|||||
136838|NCT00498485|Primary|Global Assessment of Change|A count was made of subject responses on a Patient Assessment of Change questionnaire where scores went from +2 [much better] thru 0 [no change] to -2 [much worse]|6 weeks|Had we completed the study, the analysis would have been a comparison of counts of those reporting being very much improved across the two treatment conditions||participants|||Number
136839|NCT00498433|Secondary|Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death||98 days|The safety population consisted of all patients who received at least one dose of study drug with at least one post-baseline safety assessment. Patients were analyzed according to treatment received.||Participants|||Number
136840|NCT00498433|Secondary|Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136841|NCT00498433|Secondary|Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136842|NCT00498433|Primary|Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136843|NCT00498433|Primary|Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period||Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136844|NCT00498433|Primary|Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period|Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136845|NCT00498433|Primary|Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136846|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Amlodipine Treatment Period|Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||ng/nl/h||95% Confidence Interval|Geometric Mean
136847|NCT00498433|Primary|Part 1: Renin Activity From Plasma During Aliskiren Treatment Period|Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||ng/nl/h||95% Confidence Interval|Geometric Mean
136848|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period|Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||pg/mL||95% Confidence Interval|Geometric Mean
136849|NCT00498433|Primary|Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period|Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||pg/mL||95% Confidence Interval|Geometric Mean
136850|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||fmol/mL||95% Confidence Interval|Geometric Mean
136851|NCT00498433|Primary|Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacodynamic data were included in the data analysis.||fmol/mL||95% Confidence Interval|Geometric Mean
136852|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98).|Day 98|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.||ng/mL||Standard Deviation|Mean
136853|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period|Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.||ng/mL||Standard Deviation|Mean
136854|NCT00498433|Primary|Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period||Day 42|Renin activity and concentration from adipose tissue and skeletal muscles were all below lower limitation of quantification (LLOQ) at all time points.|||||
136855|NCT00498433|Primary|Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.|Day 42|More than 50% of the biopsy samples over all time points were either below lower limit of quantification (LLOQ) or not received.|||||
136856|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period|Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis.||ng/g||Standard Deviation|Mean
136857|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 98|Due to technical limitations, zero flow concentrations could not be derived for Ang II.|||||
136858|NCT00498433|Primary|Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.|Day 42|Due to technical limitations, zero flow concentrations could not be derived for Ang II.|||||
136859|NCT00498433|Secondary|Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136860|NCT00498433|Secondary|Part 2: Change From Baseline in Official Blood Pressure||Placebo Baseline (Day 14), Active Treatment (Day 98)|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136861|NCT00498433|Secondary|Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)||Day 14 and Day 98|Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.|||||
136862|NCT00498433|Primary|Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98).|Day 98|Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes.|||||
136863|NCT00498433|Primary|Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period|Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42).|Day 42|All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics (PK)/ pharmacodynamics (PD) data were included in the data analysis.||ng/mL||Standard Deviation|Mean
136864|NCT00498368|Secondary|Biochemical Marker Immunoglobulin G (IgG) AutoAb at 12 Months||12 months|The number of participants differs from the participant flow because not all participants had the laboratory test done.||U/ml||Standard Deviation|Mean
136873|NCT00498355|Primary|The Mean Change at 3 Months in BSCVA From Baseline|The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters.|baseline and 3 months|6 patients completed all assessment points. One patient decided not to continue for nonmedical reasons, but they did complete the baseline, 1-week and 1-month assessment.||letters||Full Range|Mean
136874|NCT00498186|Secondary|Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).||participants|||Number
136875|NCT00498186|Primary|Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.|Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Up to five years|Of the 295 subjects who entered the study, 295 are included in this summary based on the Safety Set (SS).||participants|||Number
136876|NCT00497874|Secondary|Change in Physical Functioning|Physical functioning was assessed using the Physical Functioning, Role Functioning, Health Perceptions, and Pain subscales of the 20-item Medical Outcomes Study Short Form survey (SF-20) (Stewart, Hays, & Ware, Jr., 1988). (SF-20 subscales assessing mental health and social functioning were omitted to get a purer measure of physical functioning). Physical functioning was computed by taking the mean of the four subscales after each was linearly transformed to range from 0-100. The change scores reported here are the difference between the physical functioning scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -100 to +100, with higher positive scores indicating more improvement in physical functioning.|Baseline, 9 months|Multiple imputation||units on a scale||Standard Deviation|Mean
136877|NCT00497874|Secondary|Number of Participants Taking Prescribed Antidepressant Medication (Medication Adherence)|At 9 months follow-up, participants who had been prescribed antidepressant medication were asked if they had started and were still taking it. Participants who were taking their medication or had stopped with their doctor's advice were considered to be adherent.|9 months|Multiple imputation||Participants|||Number
136878|NCT00497874|Secondary|Number Participants Without Major Depression at Baseline Who Experienced the Onset of Major Depression During Follow-up|At baseline and follow-up, Major Depression was assessed using 9-item depression module of the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire—PHQ-9 (Spitzer, Kroenke, & Williams, 1999). In this analysis, Major Depression was assessed among participants not meeting criteria for major depression at baseline.|9 months|Multiple imputation||Participants|||Number
136879|NCT00497874|Secondary|Number of Participants in the Action or Maintenance Stage for Using Effective Methods to Prevent Depression.|Depression prevention was defined as: “Using effective methods to keep depression from occurring, or if it does occur, to keep it as mild and brief as possible.” Effective methods were: 1) controlling negative thinking; 2) engaging in healthy, pleasant activities; 3) practicing stress management; 4) exercising; and 5) getting professional help when needed. Patients who reported that they were not currently practicing depression prevention and had no intention of doing so in the next 6 months were classified in the precontemplation stage; those who intended to practice depression prevention in the next 6 months or next 30 days were classified in the contemplation or preparation stage, respectively; those who had been practicing depression prevention for less than 6 months were in the action stage, and those who had been practicing for more than 6 months were in maintenance. This outcome represents the number of participants in the action or maintenance stage at 9 months follow-up.|9 months|Multiple imputation||Participants|||Number
136880|NCT00497874|Secondary|Number of Participants Exhibiting a Reliable and Clinically Significant Change in Depression Severity|Two statistical criteria (Jacobson & Truax, 1991a; Atkins, Bedics, McGlinchey, & Beauchaine, 2005) were used to define reliable and clinically significant improvement. The first involved selecting a cutoff that represents remission or the absence of symptoms, which was selected to be BDI-II < 9. The second involved selecting a pre-post difference score that represents a statistically reliable change (e.g., how much change—1 point, 5 points, 10 points—is needed to be 95% confident that a real change has occurred, rather than just a chance fluctuation due to the unreliability of the measure?) Using a general formula for calculating reliable change that incorporates test-retest reliability (Jacobson & Truax, 1991b), reliable change for the BDI-II was calculated to be 5.13, and rounded down to 5. Thus, reliable and clinically significant improvement on the BDI-II was defined as a reduction of 5 or more points from baseline to follow-up and a follow-up score < 9.|9 months|Multiple imputation||Participants|||Number
136881|NCT00497874|Primary|Change in Depression Severity|Depression was assessed using the Beck Depression Inventory, 2nd Edition (BDI-II)(Beck, Steer, & Brown, 1996). In this self-report measure, 21 symptoms of depression are rated on a 0-3 scale. Scores for the 21 items are summed to yield a total score ranging from 0 to 63. The change scores reported here are the difference between the total BDI-II scores at baseline and 9 months (i.e., 9 months minus baseline). Change scores range from -63 to +63, with larger negative scores indicating greater reduction in depression.|Baseline, 9 months|Multiple imputation||units on a scale||Standard Deviation|Mean
136882|NCT00497796|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of VP 44469 (a metabolite of maribavir) concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for VP 44469 was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The PK population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
142083|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
136883|NCT00497796|Secondary|Plasma Concentration of Maribavir During Treatment|For the first 16 subjects to have PK profiling performed, PK sampling was collected at Weeks 2, 6 and 10. For subsequent subjects that have PK profiling performed, PK sampling was collected at Weeks 2 and 6. Samples were collected 12 hours after the morning dose of maribavir. Permissible assessment windows for pharmacokinetic profile sampling purposes were +/- 5 days for each sampling day. Samples for determination of maribavir concentration were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. For plasma, the minimum detectable concentration for maribavir was 0.2 μg/mL.|12 hours post-dose after 2, 6, and 10 weeks of treatment|The Pharmacokinetic (PK) population, defined as those participants in the ITT-S population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
136884|NCT00497796|Secondary|Percent of Participants With Signs of Bone Marrow Suppression|Bone marrow suppression was assessed by the occurrence of adverse events (AEs) of investigator-reported leukopenia, neutropenia, thrombocytopenia, and pancytopenia; absolute neutrophil count (ANC) <1000/mm3; white blood cell (WBC) count toxicity grade shifts from 0-2 at baseline to a maximum of 3-4 post-baseline; and use of hematopoietic growth factors during the 6 month post-transplant period.|15 weeks|The ITT-S population, defined as all participants who received at least one dose of study drug.||percent of participants|||Number
136885|NCT00497796|Secondary|Number of Participants Who Died Within 6 Months Post-Transplantation||6 months post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.||participants|||Number
136886|NCT00497796|Secondary|Number of Participants With Acute Graft Rejection|Rejection was assessed by examining a liver biopsy sample. Diagnosis of graft rejection included a global assessment grade and a rejection activity index score.|26 weeks post-transplant|The ITT-S population, defined as all participants who received at least one dose of study drug.||participants|||Number
136887|NCT00497796|Secondary|Number of Participants With Graft Failure Related Death||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-S population, defined as all participants who received at least one dose of study drug.||participants|||Number
136888|NCT00497796|Secondary|Number of Participants With Retransplantation||Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant)|The ITT-Safety (ITT-S) population, defined as all participants who received at least one dose of study drug.||participants|||Number
136889|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
136890|NCT00497796|Secondary|Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
136891|NCT00497796|Secondary|Number of Participants With Investigator-determined CMV Disease|Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant)|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
136892|NCT00497796|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by pp65 Antigenemia or CMV DNA PCR from a central or local lab. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||days||Inter-Quartile Range|Median
136893|NCT00497796|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation|Incidence of CMV infection or EC-confirmed CMV disease within the 6-month post-transplant period included in this section were defined (1) with infection assessed by pp65 antigenemia assay; (2) with infection assessed by CMV DNA PCR; (3) with infection assessed by either assay (pp65 antigenemia or CMV DNA PCR); and (4) with infection assessed by initiation of anti-CMV therapy.|6 months post-transplant|The ITT-M population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||participants|||Number
136894|NCT00497796|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction [PCR] assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The modified Intent-to-Treat (ITT-M) population, defined as all randomized subjects who received at least one dose of study drug and had participated in the study for at least 14 weeks or had the potential to receive 14 weeks of therapy by 12-Feb-2009.||number of participants with event|||Number
136895|NCT00497770|Secondary|Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)|The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.|Baseline and end of treatment (up to 20 cycles [14 months])|The number of participants who had measurements for the subscale at those time points.||participants||Standard Deviation|Mean
136896|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone|The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
136897|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping|The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
136898|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications|The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
136899|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities|The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
136900|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances|The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
136901|NCT00497770|Secondary|Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation|The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
136902|NCT00497770|Secondary|Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals|The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.|beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])|All participants enrolled in the study.||percentage of participants|||Number
136903|NCT00497770|Secondary|Progression Free Survival|Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.|baseline to measured progressive disease or death (up to 20 cycles [14 months])|All participants enrolled in the study.||months||95% Confidence Interval|Median
136904|NCT00497770|Secondary|Overall Survival|Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 20 cycles [14 months])|All participants enrolled in the study.||months||95% Confidence Interval|Median
136905|NCT00497770|Primary|Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)|Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.|baseline to measured progressive disease (up to 20 cycles [14 months])|"Of the 434 participants enrolled, 50 participants had a response status at the end of pemetrexed treatment indicating Not done/Missing and were not included in this analysis."||percentage of participants|||Number
136906|NCT00497198|Primary|Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward||percentage||Standard Error|Mean
136907|NCT00497198|Primary|Hemoglobin A1c (HbA1c) at Baseline||0 weeks|Per protocol set||percentage||Standard Deviation|Mean
136908|NCT00497198|Primary|Change From Baseline in Blood Glucose at Week 12||12 weeks (baseline to week 12)|Per protocol set; Last observation carried forward||mg/dL||Standard Error|Mean
136909|NCT00497198|Primary|Fasting Plasma Glucose at Baseline||0 weeks|Per protocol set||mg/dL||Standard Deviation|Mean
136910|NCT00497198|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12||12 weeks (baseline to week 12)|||mg/dL||Standard Error|Mean
136911|NCT00497146|Secondary|Change in Progression of Left Ventricular Ejection Fraction|Change from baseline to Week 48 in left ventricular ejection fraction.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||percent||Standard Error|Least Squares Mean
136912|NCT00497146|Secondary|Change in Progression of Left Ventricular End-diastolic Volume Index|Change from baseline to Week 48 in left ventricular end-diastolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters/meter^2.7||Standard Error|Least Squares Mean
136913|NCT00497146|Secondary|Change in Progression of Left Ventricular End-systolic Volume Index|Change from baseline to Week 48 in left ventricular end-systolic volume index.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters/meter^2.7||Standard Error|Least Squares Mean
136914|NCT00497146|Secondary|Change in Progression of Aortic Compliance|Change from baseline to Week 48 in aortic compliance.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||10^-4 cm^2/mmHg||Standard Error|Least Squares Mean
136915|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Wall Volume|Change from baseline to Week 48 in thoraco-abdominal aortic wall volume|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters||Standard Error|Least Squares Mean
136916|NCT00497146|Secondary|Change in Progression of Thoraco-abdominal Aortic Plaque Volume|Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters||Standard Error|Least Squares Mean
136917|NCT00497146|Secondary|Change in High Sensitivity C-reactive Protein (hsCRP)|High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milligrams/liter||Standard Error|Least Squares Mean
136918|NCT00497146|Secondary|Change in B-type Natriuretic Peptide (BNP)|B-type natriuretic peptide (BNP) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||log nanograms/liter||Standard Error|Least Squares Mean
136919|NCT00497146|Secondary|Change in Troponin-T|Troponin-T is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||micrograms/liter||Standard Error|Least Squares Mean
136920|NCT00497146|Secondary|Change in Interleukin-6 (IL-6)|Interleukin-6 (IL-6) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||nanograms/liter||Standard Error|Least Squares Mean
136921|NCT00497146|Secondary|Change in Plasma Triiodothyronine (T3)|Plasma triiodothyronine (T3) is a biological and inflammatory marker.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||nanomoles/liter||Standard Error|Least Squares Mean
136922|NCT00497146|Secondary|Change in Left Atrial Volume|Left atrial volume is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||milliliters||Standard Error|Least Squares Mean
136923|NCT00497146|Secondary|Change in Isovolumetric Relaxation Time (IVRT)|Isovolumetric relaxation time (IVRT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||seconds||Standard Error|Least Squares Mean
136924|NCT00497146|Secondary|Change in E-wave Deceleration Time (DT)|E-wave deceleration time (DT) is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||seconds||Standard Error|Least Squares Mean
136925|NCT00497146|Secondary|Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')|The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||ratio||Standard Error|Least Squares Mean
136926|NCT00497146|Secondary|Change in Diastolic Mitral Annular Relaxation Velocity (E')|Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.|Baseline to 48 weeks|The intent-to-treat (ITT) population, participants with available data.||centimeters/second||Standard Error|Least Squares Mean
136957|NCT00496782|Secondary|Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24|Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24|Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Gene Sequence|||Number
136927|NCT00497146|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)|The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.|Baseline to 48 weeks|The analysis was based on the intent-to-treat (ITT) population, defined as all randomized participants who took at least one dose of study drug, with available data.||grams/meter^2.7||Standard Error|Least Squares Mean
136928|NCT00497081|Primary|Frequency of Adverse Events Reported||From Baseline (week 0) through Final Visit (week 12)|||Adverse Events Reported|||Number
136929|NCT00497081|Primary|Proportion of Days With Recorded Pill Bottle Opening, as Determined by MEMS.|Proportion of days with recorded pill bottle opening, as determined by MEMS (medication event monitoring system).|Daily, from Baseline (week 0) through Final Visit (week 12)|||Percentage of recorded openings||Standard Deviation|Mean
136930|NCT00497081|Primary|Change in Number of Positive Methamphetamine Urine Tests, Comparing Baseline (Week 0) to Final Visit (Week 12).||Baseline (week 0) and Final Visit (week 12)|||Percentage reduction|||Number
136931|NCT00497055|Primary|To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.||Total reported adverse events (throughout study, up to 12 weeks)|||total reported adverse events|||Number
136932|NCT00497055|Primary|To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.|To measure the acceptability of aripiprazole and placebo among methamphetamine-dependent individuals, by determining (via electronic pill caps [MEMS or Medication Event Monitoring System]) medication adherence to aripiprazole and placebo. (Percent adherence from MEMS is determined by 100* the number of days where MEMS registered an opening out of the number of days a dose was prescribed for each arm.)|Adherence as determined by MEMS (throughout study, up to 12 weeks)|||percent adherence from MEMS||Standard Deviation|Mean
136933|NCT00497055|Primary|To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.|To test the hypothesis that aripiprazole 20 mg daily will reduce methamphetamine use significantly more than placebo among methamphetamine-dependent individuals, as determined by the proportion of methamphetamine-positive urines in the aripiprazole versus placebo group.|Final study visit at week 12|||perc of positive urines at final visit|||Number
136934|NCT00496964|Secondary|Muscle Activation During Maximal Contractions and Fatigue Contractions||4, 6, 12 weeks||||||
136935|NCT00496964|Secondary|Knee Extensor Fatigue||4, 6, 12 weeks||||||
136936|NCT00496964|Secondary|Maximal Knee Extensor Force During Concentric and Isometric Contractions||4, 6, 12 weeks||||||
136937|NCT00496964|Primary|Lower Extremity Functional Scale||4, 6, 12 weeks||||||
136938|NCT00496964|Primary|Functional Index Questionnaire||4, 6, 12 weeks||||||
136939|NCT00496964|Primary|Change in Anterior Knee Pain Scale.|"Anterior Knee Pain Scale: a 13-item questionnaire; a TOTAL score of 0 = severe disability; a score of 100 = no pain or disability. (items are scored 0-5 or 0-10).~Change scores at 12 wks are reported. Inverted so positive values reflect improvement.~Included items: difficulty with: weight bearing, walking, stairs, squat, run, jump, prolonged sitting; presence of limp, swelling, patellar subluxation, atrophy of thigh, reduced knee flexion. Reference: Kujala et al: Scoring of Patellofemoral Disorders. J Arthroscopic Rel Surg, 9(2)159-163, 1993"|4, 6, 12 weeks|The Anterior Knee Pain Scale is a 13-item questionnaire; a score of 0 = severe disability; a score of 100 = no pain or disability. Change scores are reported. Positive values = improvement in symptoms.||Units on Scale||Standard Deviation|Mean
136940|NCT00496964|Primary|Visual Analog Scale Pain Ratings (VAS)|Visual Analog Scale pain rating (VAS). 10 cm line with anchors at 0 (no pain) and 10 cm (worst imaginable pain). Scores are in cm (0 - 10) 0 no pain, higher values greater pain. Results given are for change at 12 weeks compared to baseline (week 12 score - baseline score)|4, 6, 12 weeks|analysis per protocol. Drop out not included in analysis. mean reduction in Visual Analog Scale for Pain (VAS) from start to 12 weeks.||cm||Standard Deviation|Mean
136941|NCT00496873|Secondary|3-Year Progression-Free Survival|Progression-free survival (PFS) was defined as time from initiation of therapy to progression of disease or death, whichever occurred first. The Kaplan-Meier method was used to estimate PFS.|PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.||percentage of participants||95% Confidence Interval|Number
136942|NCT00496873|Primary|Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy|Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.|9 cycles of 21 days, up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.||participants|||Number
136958|NCT00496782|Secondary|Number of Subjects With Susceptibility to Maraviroc|Phenotypic susceptibility to maraviroc|Screening (Day -21 to 0), Day 14, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Participants|||Number
136959|NCT00496782|Secondary|Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening|Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening|Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Gene Sequence|||Number
136943|NCT00496873|Primary|Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999|Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.|Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months|Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.||Percentage of Participants|||Number
136944|NCT00496860|Secondary|Immunogenicity of ALT-801|Titer of anti-drug Abs at week 4|24 months|||titer||Standard Error|Mean
136945|NCT00496860|Secondary|ALT-801 Induced Cell-mediated Immune Responses|Number of tumor-responsive (interferon-gamma positive (IFNg+)) immune cells in blood post dosing|24 months|||IFNg spots per million PMBCs||Standard Error|Mean
136946|NCT00496860|Secondary|Clinical Antitumor Response to ALT-801|Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD). CR is defined as disappearance of all tumor lesions selected for measurement. PR is defined as at least 30% decrease in the sum of all tumor lesions selected for measurement. Stable disease is defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for progressive disease (PD) which is defined as at least 20% increase the sum of the all tumor lesions selected for measurement.|24 months|||participants|||Number
136947|NCT00496860|Primary|The Maximum-tolerated Dose (MTD) of ALT-801|Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.|18 months|||events|||Number
136948|NCT00496860|Primary|The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies|Number of serious adverse events per cohort|18 months|||Events|||Number
136949|NCT00496834|Secondary|Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.||mm Hg||Standard Deviation|Mean
136950|NCT00496834|Secondary|Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug||Baseline and 24 weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94) Missing data were imputed by the last observation carried forward (LOCF) technique.||mm Hg||Standard Deviation|Mean
136951|NCT00496834|Primary|PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.|Baseline and 24 Weeks|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). Missing data were imputed by the last observation carried forward (LOCF) technique. For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.||meters/second||Standard Deviation|Mean
136952|NCT00496834|Primary|Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug|Analysis was performed in the modified intention to treat (mITT) population.|Baseline and 24 Weeks|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94). Missing data were imputed by the last observation carried forward (LOCF) technique.||meters/second||Standard Deviation|Mean
136953|NCT00496808|Secondary|Mean Percent of Ki-67|Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Analysis was per protocol. Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.||Percentage of Ki-67||Standard Deviation|Mean
136954|NCT00496808|Primary|Number of Participants Achieving Documented Change in Proliferation|Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student’s t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.|Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks|Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.||Participants|||Number
136955|NCT00496808|Primary|Percent Change in Proliferation as Measured by Ki-67|Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.|Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks||||||
136956|NCT00496782|Secondary|Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc||Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Gene Sequence|||Number
136960|NCT00496782|Secondary|Change in Detectable Tropism From Baseline|Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation|Baseline, Day 15 and Week 24/End of Study/Discontinuation|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Participants|||Number
136961|NCT00496782|Secondary|Change in Detectable Tropism From Screening|Number of subjects who switch their tropism status from screening to Baseline|Screening (Day -21 to 0), Baseline.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Participants|||Number
136962|NCT00496782|Secondary|Change in Lymphocyte Subsets; CD4 and CD8 From Screening.|Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening}|Screening (Day -14 to 0), Day 1.|Study was canceled with only 16 subjects of 60 subjects required to enroll.||cells/µL||Standard Deviation|Mean
136963|NCT00496782|Secondary|Change in Lymphocyte Subset CD8 From Day 1|Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1|Day 1(Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||cells/µL||Standard Deviation|Mean
136964|NCT00496782|Primary|Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay|Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism|Baseline, Day 4, 7, 14|Study was canceled: no efficacy data (primary/secondary) was collected per protocol for limited number of patients left in study; only safety data was summarized.||percentage of participants|||Number
136965|NCT00496782|Secondary|Change in Lymphocyte Subset CD4 From Baseline|Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1|Day 1 (Baseline), Day 7, 14, 28 and Weeks 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||cells/µL||Standard Deviation|Mean
136966|NCT00496782|Secondary|Time to Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||Days||Standard Deviation|Median
136967|NCT00496782|Secondary|Subjects With Virologic Failure|For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||participants|||Number
136968|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <50 Copies/mL|Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||participants|||Number
136969|NCT00496782|Secondary|Subjects Achieving HIV-1 RNA <400 Copies/mL|Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point|Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24|Study was canceled with only 16 subjects of 60 subjects required to enroll.||participants|||Number
136970|NCT00496769|Secondary|Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.||Percentage of events per year|||Number
136971|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|ULN=upper limit of normal; LLN=lower limit ofnormal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable||Participants|||Number
136972|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable||Participants|||Number
137047|NCT00496340|Primary|Incidence of Greater Than or Equal to 50% Donor Chimerism|The primary endpoint was achievement of >/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).|28 days post-transplant|All participants||percentage of participants|||Number
136973|NCT00496769|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality|BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug. n=number evaluable||Participants|||Number
136974|NCT00496769|Primary|Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.||Percentage of events per year|||Number
136975|NCT00496769|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose of study drug (Day 1) to 30 days after last dose of blinded study drug|Participants who received at least 1 dose of study drug.||Participants|||Number
136976|NCT00496769|Secondary|Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period|Event rate=percent of participants with an event divided by the total participants in the arm.|First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010|Participants who received at least 1 dose of study drug.||Percentage of events per year|||Number
136977|NCT00496769|Secondary|Event Rates of Major Vascular Events (Stroke/Systemic Embolism, Myocardial Infarction, Death) in the Intended-treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm.|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug||Percentage of events per year|||Number
136978|NCT00496769|Primary|Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period|Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)|Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)|Participants who received at least 1 dose of study drug.||Percentage of events|||Number
136979|NCT00496730|Other Pre-specified|Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.||Baseline and Week 8|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||mg/dL||Standard Deviation|Mean
136980|NCT00496730|Secondary|Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.|"Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.~LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk)."|Baseline and 8 weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||Participants attaining LDL-C goal|||Number
136981|NCT00496730|Primary|Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.||Baseline and 8 Weeks|All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||Percent of Baseline Value||Standard Deviation|Mean
136982|NCT00496626|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all participants who were vaccinated at least one dose and had safety follow-up data||Participants|||Number
136997|NCT00496470|Secondary|Serum Tumor Necrosis Factor-alpha (TNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
136998|NCT00496470|Secondary|Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
142084|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
136983|NCT00496626|Secondary|Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7|"Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively.~Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.||Participants|||Number
136984|NCT00496626|Primary|Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)|"Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array.~The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) <7, <8, <11, <10 respectively)"|Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7|Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.||mMU/mL||95% Confidence Interval|Geometric Mean
136985|NCT00496483|Secondary|Safety Evaluation|A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.|52 days|All enrolled patients are included in the safety population.||participants|||Number
136986|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.|Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~Arithmetic mean and standard deviation is given below."||percentage||Standard Deviation|Mean
136987|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.|Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.||hour||Full Range|Mean
136988|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.|Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome).|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
136989|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."||ng*hr/mL||Standard Deviation|Mean
136990|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).|Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
136991|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).|Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."||ng*hr/mL||Standard Deviation|Mean
136992|NCT00496483|Primary|Evaluation of Steady State Tacrolimus Trough Levels (C24).|Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.|7 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate.~The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
136993|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.|Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~Arithmetic mean and standard deviation is given below."||percentage||Standard Deviation|Mean
136994|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.|Tmax was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.||hour||Full Range|Mean
136995|NCT00496483|Secondary|Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.|Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome).|21 days|"48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit.~The arithmetic mean and standard deviation is given."||ng/mL||Standard Deviation|Mean
136996|NCT00496470|Secondary|Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
142085|NCT00452361|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 24|Value at Week 24 minus value at baseline.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
136999|NCT00496470|Secondary|Serum Monocyte Chemoattractant Protein-1 (MCP-1)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
137000|NCT00496470|Secondary|Serum Interleukin 8 (IL-8)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
137001|NCT00496470|Secondary|Serum Interleukin 6 (IL-6)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
137002|NCT00496470|Secondary|Serum High-sensitivity C-reactive Protein (hsCRP)|Ratio of treatment period mean to run-in value|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Ratio||Inter-Quartile Range|Median
137003|NCT00496470|Secondary|Severe COPD Exacerbations|Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation|12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Participants|||Number
137004|NCT00496470|Secondary|COPD Symptoms, Cough Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
137005|NCT00496470|Secondary|COPD Symptoms, Chest Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
137006|NCT00496470|Secondary|COPD Symptoms, Sleeping Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
137007|NCT00496470|Secondary|COPD Symptoms, Breathing Score|Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Units on a Scale||Standard Deviation|Mean
137008|NCT00496470|Secondary|Use of Rescue Medication, Total|Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
137009|NCT00496470|Secondary|Use of Rescue Medication, Day|Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
137010|NCT00496470|Secondary|Use of Rescue Medication, Morning|Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
137011|NCT00496470|Secondary|Use of Rescue Medication, Night|Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Inhalations||Standard Deviation|Mean
137012|NCT00496470|Secondary|Capacity of Day Living in the Morning (CDLM) Score|"Daily diary record. Change in average values from run-in to the full treatment period.~The CDLM questionnaire is as a questionnaire to report on patient’s ability to carry out each of six different morning activities (score ranging from 0 “not performed” to 1”performed”) and rank the difficulty of performing each of those activities (score ranging from 0 “so difficult that the activity could not be carried out by the patient on their own” to 5 “activity was not at all difficult to carry out”. Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
137013|NCT00496470|Secondary|GCSQ Score, 15 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|||Scores on a scale||Standard Deviation|Mean
142145|NCT00451204|Secondary|Confirmed Relapse, Probability of First Relapse||24 months|All included as intention to treat||probability of relapse at 24 months||95% Confidence Interval|Mean
137014|NCT00496470|Secondary|GCSQ Score, 5 Minutes Post-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
137015|NCT00496470|Secondary|Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose|"Daily diary record. Change in average values from run-in to the full treatment period.~The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions."|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Scores on a scale||Standard Deviation|Mean
137016|NCT00496470|Secondary|Morning Diary FEV1, 15 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137017|NCT00496470|Secondary|Morning Diary FEV1, 5 Minutes Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137018|NCT00496470|Secondary|Evening Diary FEV1, Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137019|NCT00496470|Secondary|Morning Diary FEV1 Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137020|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 15 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
137021|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) 5 Min Post-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
137022|NCT00496470|Secondary|Evening Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
137023|NCT00496470|Secondary|Morning Peak Expiratory Flow (PEF) Pre-dose|Daily diary record. Change in average values from run-in to the full treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters/minute||Standard Deviation|Mean
137024|NCT00496470|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score|"Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).~SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life."|Baseline and 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Score on a scale||Standard Deviation|Mean
137025|NCT00496470|Secondary|Inspiratory Capacity (IC) 60 Minutes Post-dose|Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137026|NCT00496470|Secondary|Inspiratory Capacity (IC) Pre-dose|Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137027|NCT00496470|Secondary|Forced Vital Capacity (FVC) 60 Minutes Post-dose|Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137046|NCT00496340|Secondary|Cumulative Incidence of Hematopoietic Cell Engraftment|Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) >/= 500/µl for 3 consecutive days or a platelet count of >/= 20,000//µl without the need for platelet support.|28 days post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
137028|NCT00496470|Secondary|Forced Vital Capacity (FVC) 5 Minutes Post-dose|Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137029|NCT00496470|Secondary|Forced Vital Capacity (FVC) Pre-dose|Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137030|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose|Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137031|NCT00496470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose|Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137032|NCT00496470|Primary|Forced Expiratory Volume in 1 Second (FEV1) Pre-dose|Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.||Liters||Standard Deviation|Mean
137033|NCT00496379|Secondary|Clinical Benefit Rate.|CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease|2 years|all pts who received at least 1 dose of protocol therapy||percentage of participants|||Number
137034|NCT00496379|Secondary|Time to Progression at Any Site.|Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0|2 years|all patients who received at least 1 dose of protocol therapy||months||Full Range|Median
137035|NCT00496379|Secondary|Objective Response Rate in Non-Central Nervous System (CNS) Sites|Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease|2 years|only included the 8 pts with measurable non-CNS disease at baseline. The 7 pts with non-measurable non-CNS disease at baseline were not included in the denominator for this endpoint||percentage of participants|||Number
137036|NCT00496379|Secondary|Number of Subjects With Adverse Events (Any Grade)|Adverse events per NCI CTCAE|2 years|Study was closed prior to full accrual for reasons detailed in published manuscript||participants|||Number
137037|NCT00496379|Primary|Objective Response Rate in the Central Nervous System (CNS)|Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.|2 years|The study was closed prior to full accrual as detailed in the manuscript||percentage of participants||95% Confidence Interval|Number
137038|NCT00496340|Secondary|Percentage of Participants With Overall Survival (OS)|OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause.|2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
137039|NCT00496340|Secondary|Percentage of Participants With Progression Free Survival (PFS)|PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., >5% blast in bone marrow or any peripheral blasts).|2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
137040|NCT00496340|Secondary|Incidence of Graft Versus Host Disease (GVHD)|"By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4.~At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD.~At 2 years, the cumulative incidence of moderate/severe chronic GVHD."|Up to 2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
137041|NCT00496340|Secondary|Time to Incidence of Graft Versus Host Disease (GVHD)|"The median time from allo-HCT to the initiation of tacrolimus (TAC) taper.~The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration."|Up to 2 years post-transplant|All participants||days||95% Confidence Interval|Median
137042|NCT00496340|Secondary|Incidence of Infections|Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning.|Up to 2 years post-transplant|All participants||participants|||Number
137043|NCT00496340|Secondary|Non-relapse Mortality Rate (NRM)|The cumulative incidence of NRM after allo-HCT.|Up to 2 years post-transplant|All participants||percentage of participants||95% Confidence Interval|Number
137044|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100|Median Percentage of Donor Cells in Study Population (Chimerism).|100 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.||percentage of cells||95% Confidence Interval|Median
137045|NCT00496340|Secondary|Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28|Median Percentage of Donor Cells in Study Population (Chimerism).|28 days post-transplant|Participants with bone marrow chimerism data available at time of analysis.||percentage of cells||95% Confidence Interval|Median
137048|NCT00496262|Secondary|Classical In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||% of expected increase in fibrinogen||Full Range|Median
137049|NCT00496262|Secondary|Incremental In Vivo Recovery (IVR)|Maximum fibrinogen activity increase in plasma per mg/kg dosed|Pre-infusion to 4 hours post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||mg/dL increase per mg/kg body weight||Full Range|Median
137050|NCT00496262|Secondary|Volume of Distribution at Steady State (Vss)|Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||mL/kg||Standard Deviation|Mean
137051|NCT00496262|Secondary|Mean Residence Time (MRT)|MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||hours||Standard Deviation|Mean
137052|NCT00496262|Secondary|Clearance (Cl)|Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||mL/hour/kg||Standard Deviation|Mean
137053|NCT00496262|Secondary|Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose|AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||hour*mg/mL||Standard Deviation|Mean
137054|NCT00496262|Secondary|Maximum Concentration (Cmax)|Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|Pre-infusion to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||g/L||Standard Deviation|Mean
137055|NCT00496262|Secondary|Terminal Elimination Half-life (t1/2)|t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.|0.5 hours to 13 days post-infusion|The pharmacokinetic analysis population (PK PP) included all subjects who received >90% of the infusion and who also had sufficient data for a reliable PK analysis (n=14).||hours||Standard Deviation|Mean
137056|NCT00496262|Primary|Maximum Clot Firmness (MCF)|MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.|Pre-infusion and 1 hour post-infusion|All subjects in the intention to treat (ITT) population. The ITT population included all subjects who received any portion of any infusion of human fibrinogen concentrate. (Note: 2 subjects in the ITT population had missing MCF data; the change from baseline MCF was entered as 0.0 for these subjects.)||millimeters||Standard Deviation|Mean
137057|NCT00496197|Secondary|Number of Participants Who Died||Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set||participants|||Number
137058|NCT00496197|Secondary|Number of Participants With Non-serious and Serious Adverse Events|AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set. An event may have been reported as both a serious and non-serious adverse event, however, what is presented are distinct events; participants may be counted as having experienced > 1 event.||participants|||Number
137059|NCT00496197|Secondary|Number of Participants Per Specified Cause of Death|Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present.|Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)|Safety analysis set is the same as the Intent-to-Treat population (ITT) and includes all participants who had taken at least 1 dose of study medication. N=number of participants who died with cause of death reported as Serious Adverse Events.||participants|||Number
137060|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)|Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.|Baseline up to End of Treatment (Day 5 up to Day 42)|Intent to Treat (ITT) population includes all participants who received at least 1 dose of study medication.||days||Standard Deviation|Mean
137061|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).||days||Standard Error|Mean
137062|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)|Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS).||days||Standard Error|Mean
137063|NCT00496197|Secondary|Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)|Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.|Baseline up to 6 Week Follow-up (EOS)|MITT; N=number of participants with analyzable data at observation. Time to dischargeable and time to discharge censored at Week 6 Follow-up (EOS).||days||Standard Error|Mean
137064|NCT00496197|Secondary|Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species|Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.|Baseline (Day 1) up to Week 6 Follow-up (EOS)|MITT; Confidence interval (CI) for the median could not be calculated by the software because no event time met the criteria for inclusion into the CI.||days||95% Confidence Interval|Number
137065|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
137066|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
137067|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
137068|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis).||participants|||Number
137069|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137070|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 6 follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137071|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 6 Follow-up (EOS)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137072|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137073|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|Week 2 follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137074|NCT00496197|Secondary|Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|Week 2 Follow-up|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137075|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOIV|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137076|NCT00496197|Secondary|Number of Participants With Clinical Response at EOIV|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137077|NCT00496197|Secondary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)|Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Intravenous treatment (Day 5 up to Day 28)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137078|NCT00496197|Secondary|Number of Participants With Microbiological Response at EOT|Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137079|NCT00496197|Secondary|Number of Participants With Clinical Response at EOT|Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.|End of Treatment (Day 5 up to Day 42)|MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137080|NCT00496197|Primary|Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)|Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).|End of Treatment (Day 5 up to Day 42)|Modified Intent to Treat population (MITT): includes all participants who received at least 1 dose of study medication and with a positive baseline culture for a Candida spp. N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis).||participants|||Number
137081|NCT00496080|Secondary|Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores|"Number of participants categorized as better in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. Better was defined as a change of -11 or less from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 18 participants.)||participants|||Number
137082|NCT00496080|Secondary|Decrease in Fibroid Bulk|"Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.~Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200."|From baseline to 12-months|ITT (Due to early termination, only 39 subjects had MRIs. No data for 8 participants.)||participants|||Number
137083|NCT00496080|Secondary|Procedural Satisfaction|"Number of participants with responses of either satisfied or very satisfied on a qualitative survey that ranged from very dissatisfied (worst) to very satisfied (best)"|12 months|ITT (No data for 19 participants)||participants|||Number
137084|NCT00496080|Secondary|Maintenance of Menses|Number of participants with continuation of menstrual cycles without interruption for three consecutive months|12 months|ITT (No data for 30 participants)||participants|||Number
137085|NCT00496080|Secondary|Mean Improvement in Health Related Quality of Life (HRQOL) Scores|"Participants categorized as better in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. Better was defined as a change of +12 or more from baseline at 12 mo."|From baseline to 12 months|ITT (No data for 20 participants)||participants|||Number
137086|NCT00496080|Primary|Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score|Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.|From baseline to 12 months|ITT (No data for 18 participants)||participants|||Number
137087|NCT00496080|Primary|No Surgical Re-intervention|Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.|Study completion|ITT (Data missing for 5 participants)||participants|||Number
137088|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
137089|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
137090|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
137091|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
137092|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
137093|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
137094|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
137095|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
137096|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
137097|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
137098|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Titer||95% Confidence Interval|Geometric Mean
137099|NCT00496054|Primary|The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Titer||95% Confidence Interval|Geometric Mean
137100|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
137120|NCT00495755|Primary|The Maximum Tolerated Dose (MTD) of a Four-week Course of Alemtuxumab in Chronic GVHD for Patients With an Incomplete Response to Steroids|MTD: The dose at which fewer or equal to 2/6 experience a dose-limiting toxicity|12 weeks|||mg|||Number
137101|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
137102|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
137103|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
137104|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results||Percentage of Participants|||Number
137105|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
137106|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
137107|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
137108|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
137109|NCT00496054|Primary|The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
137110|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results.||Percentage of Participants|||Number
137111|NCT00496054|Primary|The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA||Baseline and Approximately 6 Months|The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data||Percentage of Participants|||Number
137112|NCT00495820|Secondary|Clinical Global Impression|The Clinical Global Impression scale is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. The severity sub-scale reported below ranges from 1-7 wherein higher scores indicate worsening severity of illness.|At 12 weeks|||units on a scale||Standard Deviation|Mean
137113|NCT00495820|Secondary|Mini-mental State Examination (MMSE) at 12 Weeks|Mini-mental State Examination (MMSE) is a commonly used screening measure for cognition with questions pertaining to orientation, registration, recall, visuo-spatial construction, attention span etc. Score on MMSE ranges from 0-30, higher scores indicating improving cognition|At 12 weeks|||units on a scale||Standard Deviation|Mean
137114|NCT00495820|Primary|Apathy Evaluation Scale Score at 12 Weeks|The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.|At 12 weeks|||units on a scale||Standard Deviation|Mean
137115|NCT00495794|Secondary|LDL Control||12 months after invention period|Includes only participants with a LDL in the 12 months after the intervention period.||mg/dl||Standard Deviation|Mean
137116|NCT00495794|Secondary|A1c Control||12 months after intervention period|Includes only participants with an A1c in the 12 months after the intervention period.||percentage of total hemoglobin||Standard Deviation|Mean
137117|NCT00495794|Primary|Change in Systolic Blood Pressure||6 months prior to 6 months after the intervention period|intention to treat analysis||mmHg||95% Confidence Interval|Mean
137118|NCT00495755|Secondary|The Effect of Alemtuzumab Therapy on Parameters of Cellular and Humoral Immunity in the Late Post Transplant Period. This Information is Exploratory in Nature Only Due to the Heterogeneity of the Anticipated Patient Population.||12||||||
137119|NCT00495755|Secondary|The Efficacy of a Four-week Course of Alemtuzumab in Patients With Steroid-refractory Chronic GVHD (cGVHD).|Efficacy measured as complete response (CR), partial response (PR), stable disease (SD) and cGVHD progression (PD). CR is defined as absence of all measurable or symptomatic cGVHD, PR is defined as a remission in some but not all involved organs. SD is defined as no measurable change in GVHD and PD is defined as progression in at least one involved organ.|12 weeks|||participants|||Number
137121|NCT00495677|Other Pre-specified|Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping|CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.|Pre-dose on Day 1|Results for this outcome were not analyzed because there were no unusual patterns of response or an unexplained excess of adverse events that warranted genotyping.|||||
137122|NCT00495677|Other Pre-specified|Number of Participants With Viral Tropism and Resistance|Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.|Screening, pre-dose on Day 1; Day 11, 25|Results for this outcome was not reported because data was collected in individual participant listings, but not summarized for analyses.|||||
137123|NCT00495677|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).|0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
137124|NCT00495677|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.||hours||Full Range|Median
137125|NCT00495677|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning|Pharmacokinetic parameter analysis population included all participants who were randomized, treated and had at least 1 of the pharmacokinetic parameters of interest in the study.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
137126|NCT00495677|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.|Day 1 up to Day 25|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.||participants|||Number
137127|NCT00495677|Primary|Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11|Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.|Baseline, Day 11|Pharmacodynamic population included all participants who were randomized, treated and had at least 1 post-dose HIV viral load measurement in the study.||log10 copies/mL||Standard Deviation|Mean
137128|NCT00495625|Primary|Number of Participants With Progressive Disease (PD) at Interim Analysis|Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.||participants|||Number
137129|NCT00495625|Primary|Number of Participants With Stable Disease (SD) at Interim Analysis|Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.||participants|||Number
137130|NCT00495625|Secondary|Number of Participants With Serious Adverse Events (SAEs)|The toxicity of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|All participants||participants|||Number
137131|NCT00495625|Secondary|Number of Participants With Overall Survival (OS)|Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC|On Treatment to Off Study - average of 7 months per participant|Participants who had not expired on their off study date.||participants|||Number
137132|NCT00495625|Secondary|Participant Time to Tumor Progression (TTP)|Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.|On Treatment to Off Study - average of 7 months per participant|Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.||months||Full Range|Mean
137133|NCT00495625|Primary|Number of Participants With Partial Response (PR) at Interim Analysis|Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000].|On Treatment to Off Study - average of 7 months per participant|17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.||participants|||Number
137168|NCT00495131|Secondary|Treatment-related Withdrawal Rate|Treatment-related withdrawal rate: patients who prematurely discontinued treatment due to treatment-related adverse events|18 months|||Participants|||Number
137134|NCT00495612|Secondary|Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16|The challenge was stopped if a patient stated that they were extremely uncomfortable and would like to leave the room, the FEV1 has decreased by 50% from the baseline value, or after 60 minutes of exposure. The duration of allergen exposure was the time from when the patient entered the exposure room until the challenge stopped, with a maximum of 60 minutes. A longer duration indicates greater tolerance of the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Minutes||95% Confidence Interval|Median
137135|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Nasal-ocular Symptom Score (NOSS) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The NOSS was defined as the total of 4 sub-scores: Nasal congestion, rhinorrhea, nasal pruritus, ocular pruritus, and ocular tearing. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum NOSS was 15 points. A lower score indicates a reduced response to the allergen exposure and fewer nasal-ocular symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Units on a scale*hours||Standard Deviation|Mean
137136|NCT00495612|Secondary|Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|The chest symptom score was defined as the total of 4 sub-scores: Chest tightness, wheezing, shortness of breath, and cough. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum chest symptom score was 12 points. A lower score indicates a reduced response to the allergen exposure and fewer respiratory symptoms.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Units on a scale*hours||Standard Deviation|Mean
137137|NCT00495612|Secondary|Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Percent change||Standard Deviation|Mean
137138|NCT00495612|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) at 20 Minutes of a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Percent change||Standard Deviation|Mean
137139|NCT00495612|Primary|Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16|Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of the baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.|Week 16|Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure at Week 16.||Percent change from pre-challenge*hours||Standard Deviation|Mean
137140|NCT00495586|Secondary|Number of Days Till the Next Exacerbation|For the assessment of the time till next exacerbation patients were monitored over a period of 365 days on a three-monthly basis. Patients were instructed to contact their physician immediately if there was any change in their health status. Diagnosis of a new exacerbation was based on the same clinical criteria described previously. For the calculation of time to the next exacerbation, all clinical failures occurring during therapy were counted as zero exacerbation-free interval days.|One year|Patients with clinical success at the end of therapy visit||Days||Inter-Quartile Range|Median
137141|NCT00495586|Primary|Number of Patients Who Were Cured|Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability|Day 9-11|Clinical cure at end of therapy visit at day 9-11 in the ITT population||Participants|||Number
137142|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase at Least 10)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.||teeth|Participants||Number
137143|NCT00495495|Secondary|Laser Fluorescence Progression-12 Month (Increase From <=20 to >=30)|The change in DIAGNOdent measurements between baseline and twelve-month visits was used as an additional secondary endpoint. Clinically significant changes for DIAGNOdent indicating caries progression would be an increase in DIAGNOdent reading of 10 or more units or an increase in DIAGNOdent reading from below 20 to above 30 units. DIAGNOdent reading using a scale from 00 to 99, with 00 indicating no caries activity and 99 indicating a high level of activity.|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.||teeth|Participants||Number
140113|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol||log CFU/mL||Standard Deviation|Mean
137144|NCT00495495|Secondary|Progression of Radiographic Scores at 12 Months|"Clinically significant changes for Bitewing x-rays indicating caries progression would be changes in x-ray criterion for lesion presence from “no” to “yes” or for lesion depth to a D1 or higher. The occlusal surface of study teeth will be evaluated using the following scale:~Lesion presence: yes /no~Lesion depth:~E1 = outer half of enamel E2 = inner half of enamel D1 = outer third of dentin D2 = middle third of dentin D3 = inner third of dentin or greater/pulpal exposure"|one year|Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations (subjects who completed all four treatment/examination visit at Baseline, 3-, 6-, 9-month as well as Final examination at 12-month.||teeth|Participants||Number
137145|NCT00495495|Secondary|Change in Caries Lesion Activity|"Change in caries lesion activity at One Year. All teeth were considered Active at Baseline~Caries Lesion Activity score:~= Inactive – surface of enamel appears whitish, brownish or black. Enamel may be shiny and feels hard and smooth when the tip of the probe is moved gently across the surface.~= Active lesion – surface of enamel appears whitish/yellowish opaque with loss of luster. The surface feels rough when the tip of the probe is moved gently across the surface."|Baseline and one year|"Analyses were based on per protocol subjects, defined as all randomized subjects with no major protocol violations.~Clinically significant changes for Activity Scores were indicated by a change in caries activity status from active to inactive. It should be noted that all teeth were considered active at baseline."||teeth|Participants||Number
137146|NCT00495495|Primary|ICDAS Severity Value|"Clinically significant changes indicating caries progression are defined as changes in ICDAS severity values from 1 or 2 to a 3 or higher, or from a 3 or 4 to a 5 or higher. The severity criteria are as follows:~0 = Sound tooth surface.~= First visual change in enamel.~= Distinct visual change in enamel.~= Localized enamel breakdown due to caries with no visible dentin.~= Underlying dark shadow from dentin, with or without localized enamel breakdown.~= Distinct cavity with visible dentin.~= Extensive distinct cavity with visible dentin."|Baseline and One Year|The study utilized a split-mouth design. The results posted are for the Per Protocol dataset. Subjects who completed all four treatment/examination visits as well as final examination visit without major protocol violations were included in this dataset.||teeth|Participants||Number
137147|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of follow up|||participants|||Number
137148|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to end of treatment|||participants|||Number
137149|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 16|||participants|||Number
137150|NCT00495391|Secondary|Changes in ALT|This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.|From baseline to week 8|||participants|||Number
137151|NCT00495391|Secondary|Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.|After 4 weeks combination treatment|||participants|||Number
137152|NCT00495391|Secondary|Early Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.|After 12 weeks combination treatment|||participants|||Number
137153|NCT00495391|Secondary|End of Treatment Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.|At end of treatment|||participants|||Number
137154|NCT00495391|Primary|Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)|Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.|24 weeks after end of treatment|||participants|||Number
137155|NCT00495222|Primary|Knotting Elements Placed|completion of plication (1-3 knotting elements placed per procedure)|intra-operative|Intent to Treat||elements|||Number
137156|NCT00495157|Secondary|Adverse Events||Measured during the 36-week treatment period||||||
137157|NCT00495157|Secondary|Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids||Measured during the 36-week treatment period||||||
137158|NCT00495157|Secondary|Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25||Measured during the 36-week treatment period||||||
137159|NCT00495157|Secondary|Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)||Measured during the 36-week treatment period||||||
137160|NCT00495157|Secondary|Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)||Measured during the 36-week treatment period||||||
137161|NCT00495157|Secondary|Number of Asthma Exacerbations||Measured during the 36-week treatment period||||||
137162|NCT00495157|Secondary|Time to First Asthma Exacerbation||Measured during the 36-week treatment period||||||
137163|NCT00495157|Secondary|Number of Episodes of Treatment Failure||Measured during the 36-week treatment period||||||
137164|NCT00495157|Primary|Time to Treatment Failure (Measured in Days)||Measured during the 36-week treatment period|All participants were followed for time to treatment failure or right censoring (measured in days).||days||Standard Error|Mean
137165|NCT00495131|Secondary|Histologic Response|Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy|18 months|Data included for analysis only for patients with paired liver biopsies.||Participants|||Number
137166|NCT00495131|Primary|Sustained Biochemical Response|Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization|18 months|Patients with end of follow-up alanine aminotransferase (ALT) levels||Participants|||Number
137167|NCT00495131|Primary|Sustained Virologic Response|Undetectable HCV RNA 6 months off therapy|18 months|Intention-to-treat (ITT) analysis by last observation carried forward||participants|||Number
137169|NCT00495079|Primary|Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation|Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC>=1X10^9/L or Platelet count>=100x10^9/L, absence of blasts in blood and morrow (<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count <100x10^9/L or ANC<1x10^9/L.|Response assessment at the end of each 28 days course|The IRRC evaluable population included all subjects who received at least 1 dose of study drug and who has reviewable data to assess and determine response or lack of response as determined by the IRRC.||participants|||Number
137170|NCT00495079|Secondary|Overall Survival|Time, in days, from informed consent date until the date of death or date of last contact|unlimited|Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT)(n=10)||days||95% Confidence Interval|Median
137171|NCT00495079|Secondary|Duration of CR + CRi|Duration of response for those subjects who achieved CR or CRi|CR + CRi duration was calculated from the date the subject first met the definition of CR or CRi until the date of relapse|Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)||days||95% Confidence Interval|Median
137172|NCT00495079|Primary|Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)|CR is defined as no evidence of ALL: ANC>or=1x10^9/L or platelet count>100x10^9/L, absence of leukemia blast cells in blood and marrow (<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count< 100x10^9/L or ANC< 1x10^9/L. Partial remission(PR):CR with>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.|Response assessment performed at the end of each 28 day course.|Subjects who had CR plus CRi by the PI and the IRRC assessments using the International Working Group Criteria. The Intent-to-Treat Analysis, n=65, minimum 1 dose. The IRRC, n=53, 1 dose, assess response as determined by the IRRC. Analyses, a Simon’s 2-stage minimax design where the type I error alpha was set at 0.10 and the power was 80%.||participants|||Number
137173|NCT00494975|Secondary|Detailed Questionnaire at Baseline and After 18 Sessions||at baseline and after 18 sessions||||||
137174|NCT00494975|Primary|Visual Analogue Scale (VAS) Score for Pruritus|"a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus.~0 (no pruritus) - 10 (most severe pruritus) The investigator will determine the pruritic intensity at baseline, every 3 sessions by VAS score, and by detailed questionnaire at baseline and after 18 sessions"|VAS score at baseline and after 6 -week phototherapy|||Units on a scale||Standard Deviation|Mean
137175|NCT00494871|Secondary|Event Rate Adjudicated Non-major Clinically Relevant Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).||Events per 100 patient-years|||Number
137176|NCT00494871|Secondary|Event Rate of Adjudicated Major Bleeding|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).||Events per 100 patient-years|||Number
137177|NCT00494871|Secondary|Event Rate of All-cause Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137178|NCT00494871|Secondary|Event Rate of Stroke With Serious Residual Disability|All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant’s modified Rankin score was between 3 and 5, inclusive.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137179|NCT00494871|Secondary|Event Rate of Vascular Death|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia)|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137180|NCT00494871|Secondary|Event Rate of Myocardial Infarction|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation.|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137192|NCT00494780|Secondary|Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]).|Week 15 (Visit 22)|FAS. Data were provided for the number of participants who had a value. Participants withdrawn during the study were not analyzed.||milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
137181|NCT00494871|Secondary|Event Rate of Non-CNS Systemic Embolism|"All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137182|NCT00494871|Secondary|Event Rate of Stroke|All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.).|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137183|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137184|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death|"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Any death that was not clearly non-vascular."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137185|NCT00494871|Secondary|Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism|"This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism”: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded."|Up to 2 days after the last dose|The per-protocol analysis population consisted of randomized participants excluding those who had specific pre-defined major protocol deviations (637 in each treatment group).||Events per 100 patient-years|||Number
137186|NCT00494871|Primary|Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding|Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.|Up to 2 days after the last dose|The safety analysis population consisted of randomized participants who took at least one dose of study treatment (639 in each treatment group).||Events per 100 patient-years|||Number
137187|NCT00494806|Primary|Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator.|Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).|Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).|Intention to treat (ITT) method was used.||Days||Standard Deviation|Mean
137188|NCT00494780|Secondary|Vss at the Sixth Infusion (Week 15, Visit 22)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Liters||Geometric Coefficient of Variation|Geometric Mean
137189|NCT00494780|Secondary|CL After the Sixth Infusion (Week 15, Visit 22)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
137190|NCT00494780|Secondary|Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)|Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
137191|NCT00494780|Secondary|AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Week 15 (Visit 22)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milligrams * hours/liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
140392|NCT00466167|Secondary|Change From Baseline in UPDRS I Score After 18 Weeks|UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Inter-Quartile Range|Median
137193|NCT00494780|Secondary|Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy|This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented.|Maximum of 6 years follow-up|FAS|||||
137194|NCT00494780|Primary|Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)|Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions).|Maximum of 23 months after the start of treatment|FAS||participants|||Number
137195|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22|The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Screening, Week -2) and Visit 22 (Week 15)|FAS. Only those participants who remained in the study at Visit 22 were analyzed.||Percent change in serum complement CH50||Full Range|Median
137196|NCT00494780|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.|Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)|FAS. Participants dropped out of the study as the study progressed.||participants|||Number
137197|NCT00494780|Secondary|Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section.|Up to 22 months after study start|FAS||participants|||Number
137198|NCT00494780|Secondary|Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Only those participants who provided samples at Visit 33 were analyzed.||Percent change in cell counts||Full Range|Median
137199|NCT00494780|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death.|Followed up to 5 years|FAS. Only those participants with a response were analyzed.||months||95% Confidence Interval|Median
137200|NCT00494780|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression or death.|Followed up to 5 years|FAS||months||95% Confidence Interval|Median
137201|NCT00494780|Secondary|Time to New Anti-follicular Lymphoma (FL) Therapy|Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed.|Followed up to 5 years|FAS||months||95% Confidence Interval|Median
137202|NCT00494780|Secondary|Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)|The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100.|Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)|FAS. Participants were withdrawn from the study between Visits 1 and 33.||Percent change in tumor size||Full Range|Median
137203|NCT00494780|Secondary|Number of Participants With Complete Remission (CR) at Visit 26|Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease.|Maximum of 23 months after the start of treatment|FAS||participants|||Number
137204|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Discontinued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility improvement scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and then discontinued wearing prism glasses.||logits||Standard Deviation|Mean
137220|NCT00494494|Primary|Pre-operative Best Corrected Visual Acuity (BCVA)|Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline|The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).||letters||Standard Deviation|Mean
140499|NCT00465101|Other Pre-specified|Length of Procedure (LOP)|Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).|Procedure|Participants who received the study treatment and for whom the outcome measure is available.||minutes||Standard Deviation|Mean
137205|NCT00494676|Secondary|Mobility Change Score (Only Participants Who Continued Prism Wear in the Long Term)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|This is a subgroup analysis of the mobility change scores for real and sham prism glasses evaluated during the crossover. The subgroup includes only those participants who completed the crossover and continued to wear prism glasses in the long term.||logits||Standard Deviation|Mean
137206|NCT00494676|Secondary|Mobility Change Score (All Participants Who Completed Crossover)|Perceived difficulties with mobility were quantified using a 5-point rating scale (no difficulty to extreme difficulty) for 7 situations (items) relevant to people with hemianopia, including at home, in stores, outdoors, in unfamiliar areas, in familiar areas, in crowded areas, and noticing objects off to the side when walking. The questionnaire was administered at baseline (without prisms) and after each period of the crossover. Interval scale measures of perceived difficulty with overall mobility for each participant were estimated using Rasch analysis of the responses to all seven items (Winsteps software, version 3.70.0.226). Rasch measures were expressed as logits (log odds ratios). Mobility change scores for real and sham prisms were defined as the difference in perceived difficulty relative to baseline (in logits).|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis||logits||Standard Deviation|Mean
137207|NCT00494676|Primary|"Overall Proportion Saying Yes to Real Prism Glasses"|"At the end of each crossover period, participants were asked a yes/no question: If the study were to end today, would you want to continue with these prism glasses (i.e. the prism glasses worn in that period)? The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants saying yes to real prism glasses and the proportion saying yes to sham prism glasses."|Evaluated after 4 weeks of wearing each type of prism glasses|Only participants who completed the crossover were included in this analysis||participants|||Number
137208|NCT00494585|Primary|Number of Participants With Objective Response|Objective response = Complete Response, absence sign/symptoms of disease (without use of growth factors, hydroxyurea, anagrelide, or transfusions for > 1 month); Partial Response, absence of progressive disease (PD), and improvement in 2+ parameters (if abnormal): Absolute neutrophil count (ANC), hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts; Clinical Improvement, absence of PD, and improvement in 1 parameter: ANC, hemoglobin, platelets, transfusions, splenomegaly, or bone marrow blasts). [International Working Group on Myelofibrosis Research and Treatment]|Response assessed after each 3 cycles (cycle = 30 days)|Intention to treat.||Participants|||Number
137209|NCT00494507|Secondary|HOP Endpoint of Acute Worsening|Increase in attack frequency or severity in HOP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks|||participants|||Number
137210|NCT00494507|Secondary|HYP Endpoint of Acute Worsening|Increase in attack frequency or severity in HYP participants necessitating withdrawal from the initial nine-week double-blind treatment period and moving directly into the open-label phase.|0-9 weeks|||participants|||Number
137211|NCT00494507|Secondary|HOP Attack Duration|HOP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks|||hours per week||Inter-Quartile Range|Median
137212|NCT00494507|Secondary|HYP Attack Duration|HYP participant total attack duration per week, defined as the sum of attack durations across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed.|8 weeks|||hours per week||Inter-Quartile Range|Median
137213|NCT00494507|Secondary|HOP Severity-weighted Attack Rate|HOP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks|||severity-weighted attacks per week||Inter-Quartile Range|Median
137214|NCT00494507|Secondary|HYP Severity-weighted Attack Rate|HYP participant severity-weighted attack rate is defined as the sum of average attack severity across all distinct attacks over the final 8 weeks (Weeks 2-9) of the double-blind treatment period divided by the number of weeks that the subject was followed. Attack severity (scored as 1-10 with increasing severity) is self-reported.|8 weeks|||severity-weighted attacks per week||Inter-Quartile Range|Median
137215|NCT00494507|Primary|HOP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HOP participants.|8 weeks|||attacks per week||Inter-Quartile Range|Median
137216|NCT00494507|Primary|HYP Attack Rate|The number of distinct attacks per week over the final 8 weeks (Weeks 2-9) of the double-blind treatment period as self-reported by HYP participants.|8 weeks|||attacks per week||Inter-Quartile Range|Median
137217|NCT00494494|Primary|Post-operative Best Corrected Visual Acuity (BCVA)|The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.|baseline and 8 weeks|||letters||95% Confidence Interval|Mean
137218|NCT00494494|Primary|Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)||baseline and 8 weeks|||microns||95% Confidence Interval|Mean
137219|NCT00494494|Primary|Foveal Thickness|difference in mean pre-post changes by the two treatment groups|baseline and 8 weeks|||microns||95% Confidence Interval|Mean
137239|NCT00494221|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)|||Percentage||Standard Deviation|Mean
137221|NCT00494494|Primary|Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)|The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)|baseline and 8 weeks|Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.||microns||95% Confidence Interval|Mean
137222|NCT00494481|Primary|Number of Patients With a Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off|||Participants|||Number
137223|NCT00494442|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.|End of study|||Days||95% Confidence Interval|Median
137224|NCT00494442|Secondary|Best Percentage Change in Tumour Size|The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).|End of study|||Percentage||Full Range|Median
137225|NCT00494442|Secondary|Duration of Response|Duration of response to olaparib|End of study|||Days||Full Range|Median
137226|NCT00494442|Secondary|Clinical Benefit (CB)|Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)|End of study|||Percentage of participants||95% Confidence Interval|Number
137227|NCT00494442|Primary|Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.|||Participants|||Number
137228|NCT00494299|Post-Hoc|Number of Death Cases Due to Any Cause||From randomization of the first subject until death due to any cause assessed up to 55 months.|"Intention to treat (ITT) population. Overall Survival is shown in Secondary Outcome Measure: Overall Survival."||Participants|||Number
137229|NCT00494299|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.|From randomization of the first subject until 39 months later.|"Median overall survival (OS) and 95% Confidence interval (CI) were not estimable in Placebo Group and Upper Limit of 95% CI was not in Sorafenib Group because of more than half (188 for Placebo,186 for Sorafenib) of the individual study populations censored. Number of death is shown in Post-Hoc Outcome Measure."|||||
137230|NCT00494299|Primary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.|Intention to treat (ITT) population.||days||95% Confidence Interval|Median
137231|NCT00494234|Secondary|Change From Baseline in ECOG Performance Status: Improvement Rate|The change in ECOG performance status was defined as improved (meaning the ECOG score is less than the baseline value), no change (ECOG is same as at baseline), worsened (ECOG score is greater than the baseline value) or missing (the ECOG score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.|At cycle 7 day 1 (ie, after completing 6 cycles of treatment)|||Participants with an improvement in ECOG|||Number
137232|NCT00494234|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression. Those patients who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where patients had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment.|End of study|||Days||95% Confidence Interval|Median
137233|NCT00494234|Secondary|Best Percent Change in Tumour Size|The tumour size is defined as the sum of the longest diameters as measured among all target lesions.|End of study|||Percent change in tumour size||95% Confidence Interval|Mean
137234|NCT00494234|Secondary|The Clinical Benefit Rate (CBR)|The Clinical Benefit Rate (CBR) is defined as the percentage of patients with a RECIST tumour response of confirmed CR, PR or stable disease (SD) for ≥8 weeks +/- 1 week visit window.|End of study|Per protocol||Percentage of Participants||95% Confidence Interval|Number
137235|NCT00494234|Secondary|Duration of Response to Olaparib||Time from response (CR or PR) to progression per RECIST criteria|Per protocol||Days||Full Range|Median
137236|NCT00494234|Primary|Confirmed Objective Tumour Response (According to RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years.|||Participants|||Number
137237|NCT00494221|Secondary|Overall Survival|Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored.|Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)|||Months||Full Range|Median
137238|NCT00494221|Secondary|Duration of Response|Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups).|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)|||Months||Standard Deviation|Mean
142146|NCT00451204|Secondary|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|24 months|Included all as intention to treat.||relapses per year||95% Confidence Interval|Mean
137240|NCT00494221|Secondary|Objective Tumour Response Rate|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)|||Participants|||Number
137241|NCT00494221|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)|||Months||Full Range|Median
137242|NCT00494143|Secondary|Peak Intact Knee Loading|The biomechanical measure of the first peak of the knee external adduction moment|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection|||newton meters per kilogram||Standard Deviation|Mean
137243|NCT00494143|Secondary|Prosthetic Foot Push Off Peak Power|The biomechanical measurement of the power generated by the prosthetic foot during the push off component of stance phase. The peak power output during the push off component of stance phase was calculated in Joules. It was subsequently standardized for body weight in Kgs. The final units were therefore Joules/Kg.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection|||joules per kilogram||Standard Deviation|Mean
137244|NCT00494143|Primary|Metabolic Oxygen Consumption During Ambulation|VO2 was collected at rest and while walking at a controlled walking speed of 1.14 meters/second for 10 minutes until they reached a steady state for 3 minutes. This was repeated for each foot condition. VO2 at the steady state was recorded in ml/min and were subsequently converted to calories and and then to Watts. The data were then corrected for body weight by dividing by weight in Kg. The gross VO2 in Watts/Kg during walking were then adjusted to net VO2 in Watts/kg by subtracting the resting metabolic rate.|Subjects were oriented to the testing protocol and each prosthetic foot on average 5 days prior to data collection and a acclimatization period of 5-10 minutes with each prosthetic foot prior to data collection|||Watts per kilogram||Standard Deviation|Mean
137245|NCT00494091|Other Pre-specified|Volume of Distribution at Steady State (Vss) of Temsirolimus|"Vss is an estimate of the volume of distribution at steady state. It is used to predict the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||Liter||Standard Deviation|Mean
137246|NCT00494091|Other Pre-specified|Clearance (CLss) of Temsirolimus|"Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of temsirolimus (R0/Css). As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||Liter per hour (L/h)||Standard Deviation|Mean
137247|NCT00494091|Other Pre-specified|Area Under the Concentration-Time Curve (AUC)|"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||ng*h/mL||Standard Deviation|Mean
137248|NCT00494091|Other Pre-specified|Plasma Decay Half-Life (t1/2)|"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Sirolimus is the major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Standard Deviation|Mean
137249|NCT00494091|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|PK population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||hours||Full Range|Median
137250|NCT00494091|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)|"Sirolimus is a major metabolite of temsirolimus. As per planned analysis, only participants in Temsirolimus 20 mg/m^2 treatment arm were to be drawn blood samples intensively for pharmacokinetic analysis."|0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study treatment and had at least 3 measurable blood concentration samples available. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
137251|NCT00494091|Secondary|Overall Survival (OS)|Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline Until Death (Up to 4 years)|ITT population included all participants who were enrolled in this study.||months||95% Confidence Interval|Median
137252|NCT00494091|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.||months||95% Confidence Interval|Median
137253|NCT00494091|Secondary|Duration of Response|Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.|Baseline Up to 4 years|Intent-to-treat ITT population included all participants who were enrolled in this study. Here N (number of participants analyzed) signifies participants with objective disease response.||months||95% Confidence Interval|Median
137254|NCT00494091|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.||percentage of participants||95% Confidence Interval|Number
137255|NCT00494091|Secondary|Progression-free Survival (PFS)|Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Baseline Up to 4 years|ITT population included all participants who were enrolled in this study.||months||95% Confidence Interval|Median
137256|NCT00494091|Primary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Baseline Up to 4 years|Intent-to-treat (ITT) population included all participants who were enrolled in this study.||percentage of participants||95% Confidence Interval|Number
137257|NCT00494026|Secondary|Pharmacology Toxicity|Radiation Therapy Oncology Group (RTOG) criteria were used for assessing toxicity. Toxicity grade reflected the most severe degree occurring during the evaluated period, not an average. When two criteria were available for similar toxicities, the one resulting in the more severe grade was used. Toxiccity grades range from 0 to 5. Toxicity grade = 5 if that toxicity caused the death of the patient.|every 21-day cycle for 4 cycles|All enrolled patients who received radiotherapy.||participants|||Number
137258|NCT00494026|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|Trial was terminated early. Results were not analyzed.||months||95% Confidence Interval|Median
137259|NCT00494026|Secondary|Overall Survival|Overall survival is the duration from enrollment to death (includes 1 year follow-up). For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause, 1 year|Trial was terminated early. Results were not analyzed.||months||95% Confidence Interval|Median
137260|NCT00494026|Secondary|Progression-free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline to measured progressive disease|Trial was terminated early. Results were not analyzed.||months||95% Confidence Interval|Median
137261|NCT00494026|Primary|Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured response after chemotherapy and radiation|Trial was stopped too early to assess the primary endpoint.||proportion of responders|||Number
137262|NCT00494013|Secondary|Number of Injections of Basal Insulin Analog at Endpoint||24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||participants|||Number
137263|NCT00494013|Secondary|Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||Units of Insulin/kilograms (U/kg)||Standard Deviation|Mean
137264|NCT00494013|Secondary|Total Daily Insulin Dose (Units) at Endpoint|Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||Units of insulin||Standard Deviation|Mean
137265|NCT00494013|Secondary|Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||kilograms (kg)||Standard Deviation|Mean
137266|NCT00494013|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||hypoglycemic events per 30 days||Standard Deviation|Mean
137267|NCT00494013|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||hypoglycemic events per 1 year||Standard Deviation|Mean
137268|NCT00494013|Secondary|Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods|Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Results are for the combined titration and maintenance periods.|Baseline to 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||participants|||Number
137269|NCT00494013|Secondary|7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint|Actual daily mean blood glucose levels at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||millimoles per liter (mmol/L)||Standard Deviation|Mean
137270|NCT00494013|Secondary|Glycemic Variability|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
137271|NCT00494013|Secondary|Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint|Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.|24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||percentage of participants|||Number
137272|NCT00494013|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks||Baseline, 12 Weeks, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement.||percent hemoglobin||Standard Error|Least Squares Mean
137273|NCT00494013|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)||Baseline, 24 Weeks|Number of randomized patients who received at least one dose of study drug and at least one post-baseline measurement. Last observation carried forward.||percent of HbA1c||Standard Error|Least Squares Mean
137274|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours|Baseline and 72 hours later|"Intent to Treat.~Participants with urine sample at both visits."||(ng/mg Cr.)||Standard Error|Log Mean
137275|NCT00493974|Secondary|Change in Urinary Leukotriene (LTE4) Levels|Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours|Baseline and 24 hours|"Intent to Treat.~Participants with urine sample at both visits."||(ng/mg Cr.)||Standard Error|Log Mean
137276|NCT00493974|Secondary|Health-related Quality of Life|"St. George's Respiratory Questionnaire - Total Score~The SGRQ was asked with respect to the last one month as validated for acute exacerbations of COPD by Doll et al.~Scale from 0 (no disability) to 100 (maximum disability).~The SGRQ total score summarizes the impact of airway specific disease on overall health status. Scores range from zero (no impairment) to 100 (maximum impairment). Scores were calculated using the SGRQ scoring Algorithm."|Change from Baseline and 1 Month|Participants were analyzed using the intent to treat method and included those that had SGRQ data at baseline and 1 month.||Units on a scale||Standard Deviation|Mean
137277|NCT00493974|Secondary|Treatment Failure|Treatment failure is defined as death, intubation, readmission to a hospital for COPD, urgent visit to an outpatient or ED provider for symptoms of COPD or intensification of therapy [including second course of antibiotics for COPD, and second course of systemic steroids for COPD]) in the first 30 days after randomization.|Baseline to day 30 visit|Participants were analyzed following intention to treat (ITT) method.||Participants|||Number
137278|NCT00493974|Secondary|Change in FEV1/FEV6 Levels|Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.|from baseline to day of discharge|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline and missing discharge data.||ratio||Standard Error|Mean
137279|NCT00493974|Secondary|Change in FEV1% Predicted|Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline.|Measured at Baseline and Day 30|Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline.||percent predicted||Standard Error|Mean
137280|NCT00493974|Primary|Length of Hospital Stay|Admission will begin at the time the subject has been admitted to an inpatient service. Length of Stay (LOS) will be recorded in days. The LOS will be based on the number of days spent in an acute medical ward or in the ICU. Subjects that are admitted and discharged in the same 24 hour period will be recorded as a LOS of 1 day, as will subjects discharged in the ensuing 24 hour period. LOS's greater than 10 days will be truncated to 10 days.|Measured at Day 30|"Participants were analyzed following intention to treat (ITT) method.~One participant randomized to Zileuton withdrew consent before hospital discharge.~Days to discharge are set at a maximum of 10 days."||Days||Standard Deviation|Median
137281|NCT00493805|Secondary|Sustained Virological Response (PCR 24 Weeks After End of Treatment)|Sustained virological response (SVR) was defined as undetectable HCV RNA in serum at the end of follow-up (24 weeks after end of therapy) according to a polymerase chain reaction (PCR) assay.|Up to 24 weeks following 48 or 72 weeks of therapy|Information on PCR was available for 7 participants in the non interventional study arm and 11 participants in the interventional study arm.||Participants|||Number
137282|NCT00493805|Primary|Early Virological Response in Participants With and Without Insulin Resistance|Early Virological Response (EVR) defined as HCV PCR at Week 12 either negative or at least 2 log units less than baseline in participants with and without insulin resistance.|At Week 12 (after start of therapy)|"Interventional arm: At baseline, PCR measurements for 38 out of 42 participants were available.~Non Interventional arm: At baseline, PCR measurements for 15 out of 17 participants were available."||Participants|||Number
137283|NCT00493779|Secondary|Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Throughout 4-week follow-up period|All enrolled patients in whom clopidogrel treatment was discontinued.||Participants|||Number
137284|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Hs-CRP|ANCOVA models performed on log scale controlling for site & natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline hs-CRP value and at least one post clopidogrel withdrawal measurement for hs-CRP value. No imputation technique for missing values was applied.||percent change||Standard Error|Mean
137285|NCT00493779|Primary|Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)|Based on ANCOVA models performed on log scale controlling for site & natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.|Week 1, Week 2, Week 3, Week 4 (primary timepoint)|Number of participants in the biomarker analysis population having a baseline soluble CD40 Ligand value (n=95) and at least one post-clopidogrel withdrawal measurement for soluble CD40 Ligand value. No imputation technique for missing values was applied.||percent change||Standard Error|Mean
137286|NCT00493779|Secondary|Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin|Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.|Week 1, Week 2, Week 3, Week 4|Number of patients in the biomarker analysis population having baseline Plasma Soluble P-selectin value (n=95) and at least one post-clopidogrel withdrawal measurement for Plasma Soluble P-selectin value. No imputation technique for missing values was applied.||percent change||Standard Error|Mean
137287|NCT00493649|Secondary|OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.||probability of overall survival||95% Confidence Interval|Number
137288|NCT00493649|Secondary|DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their cMYC amplification were unknown.||probability of disease-free survival||95% Confidence Interval|Number
137289|NCT00493649|Secondary|Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.||probability of overall survival||95% Confidence Interval|Number
137290|NCT00493649|Primary|Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.|DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.|2 years|ITT population. Patients were excluded if their TOP2A amplification were unknown.||probability of disease-free survival||95% Confidence Interval|Number
137291|NCT00493636|Secondary|Duration of Overall Response|Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.|||Days||95% Confidence Interval|Median
137307|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.||participants|||Number
137711|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137292|NCT00493636|Secondary|Overall Response Rate|Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.|||percentage of participants|||Number
137293|NCT00493636|Secondary|Time to Progression||Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.|||Days||95% Confidence Interval|Median
137294|NCT00493636|Secondary|Overall Survival||From the date of randomization to date of death due to any cause, assessed up to 56 months.|||Days||95% Confidence Interval|Median
137295|NCT00493636|Primary|Progression Free Survival||From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.|||Days||95% Confidence Interval|Median
137296|NCT00493454|Primary|Objective Response Rate|Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.|Evaluation 4 weeks after administration of Zevalin up to 3 years|One participant did not receive treatment and was excluded from analysis.||proportion of participants|||Number
137297|NCT00493311|Secondary|Global Assessment of Treatment at T360 Minutes or Early Termination.|"Subject Global Evaluation was assessed by subject using a 4 point categorical scale in response to the following question:Overall, how would you rate the study treatments? 0 = Poor~= Fair~= Good~= Excellent"|Baseline (T0) to 6 hours|||participants|||Number
137298|NCT00493311|Secondary|The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)||360 minutes (6 hours after study drug administration)|||Percentage of participants|||Number
137299|NCT00493311|Secondary|Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)||Baseline (T0) to 360 minutes (6 hours) post study drug administration|||Degrees celsius||Standard Deviation|Mean
137300|NCT00493311|Secondary|Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.|WSTD3 is defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through the first 3 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 3 hours|||Degrees Celsius||Standard Deviation|Mean
137301|NCT00493311|Primary|Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever|The primary efficacy endpoint was WSTD6 defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through 6 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.|Baseline (T0) to 6 hours post study drug administration|||Degrees Celsius||Standard Deviation|Mean
137302|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.||participants|||Number
137303|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.||participants|||Number
137304|NCT00493285|Secondary|Number of Participants With Seroresponse to PIV3 28 Days After Dose 1|Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3. Hemagglutination inhibition antibody results obtained on or after detection of wild-type HPIV3 in culture were not considered valid.||participants|||Number
137305|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 3|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.||participants|||Number
137306|NCT00493285|Secondary|Number of Participants With Seroresponse to RSV 28 Days After Dose 2|Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for RSV.||participants|||Number
142251|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
137308|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137309|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137310|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137311|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline|Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137312|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137313|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137314|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1|Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Day 28-34 after Dose 1 (Dose 1 was on Day 0)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137315|NCT00493285|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline|Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed.|Baseline (Day 0 prior to Dose 1)|The immunogenicity population included all subjects who received investigational product and had valid results from serum samples obtained for immunogenicity evaluation for PIV3 and/or RSV.||GMT||95% Confidence Interval|Mean
137316|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137317|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137318|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137319|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137320|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137321|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137322|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
142288|NCT00449150|Secondary|Quality Of Life||Patient questionnaire||||||
137323|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 2 (Dose 2 was on Day 48-64)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137324|NCT00493285|Secondary|Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 0-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137325|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 28-34 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137326|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 12-18 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137327|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7-10 after Dose 1 (Dose 1 was on Day 0)|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137328|NCT00493285|Secondary|Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation|Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR.|Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose.|The shedding population included all subjects who received investigational product and had any valid shedding data.||participants|||Number
137329|NCT00493285|Primary|Number of Participants With Significant New Medical Conditions (SNMCs)|A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later|Safety population was participants who received investigational product and had any safety follow-up for ≥ 1 day after dosing (ie, did not discontinue on Day 0 after receiving Dose 1).||participants|||Number
137330|NCT00493285|Primary|Number of Participants With Serious Adverse Events (SAEs)|Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes.|Days 0-28 after any dose|The safety population included all subjects who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
137331|NCT00493285|Primary|Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs)|An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea.|Days 0 to 180 days after final dose or the end of the RSV season, whichever was later|The safety population for MA-LRIs included randomized participants who received investigational product and had any safety follow-up.||participants|||Number
137332|NCT00493285|Primary|Number of Participants With AEs After Dose 3|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
137333|NCT00493285|Primary|Number of Participants With AEs After Dose 2|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
137334|NCT00493285|Primary|Number of Participants With Adverse Events (AEs) After Dose 1|Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|The safety population for AEs included randomized participants who received investigational product for the specified dose and had any safety follow-up.||participants|||Number
137335|NCT00493285|Primary|Number of Participants With SEs After Dose 3|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
137336|NCT00493285|Primary|Number of Participants With SEs After Dose 2|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 2 (Dose 2 was on Day 48-64)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose.||participants|||Number
137337|NCT00493285|Primary|Number of Participants With Solicited Adverse Events (SEs) After Dose 1|The SEs for this study included fever ≥ 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis.|Days 0-28 after Dose 1 (Dose 1 was on Day 0)|Safety population for solicited symptoms included randomized participants who received investigational product for the specified dose and had any solicited symptom data obtained after that dose||participants|||Number
137338|NCT00493246|Secondary|Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)|A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV acetaminophen that; Results in Death, Is life-threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is an important medical event|First dose to 30 days following last dose of study medication|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of IV acetaminophen.||Participants|||Number
137339|NCT00493246|Secondary|Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)|A TEAE is defined as an adverse event that starts on or after the start of study medication|First dose of study medication to 30 days after the last dose of study medication|||Participants|||Number
137340|NCT00493246|Primary|Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen|t1/2: Terminal elimination half-life|48hrs|"Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the last dose of IV acetaminophen.~Due to only one subject in the Neonate 15mg/kg group, t1/2 (h) was not calculated."||Hours||Full Range|Median
137341|NCT00493246|Primary|Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen|AUC 0-t (µg*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state.|Time Zero (just prior to first dose) to 48 hours post first dose|||µg*h/ml||Full Range|Median
137342|NCT00493246|Primary|Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen|Tmax: Time to reach maximum plasma concentration (Cmax)|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.||Hour||Full Range|Median
137343|NCT00493246|Primary|Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen|Cmax: Maximum Plasma Concentration|Time Zero (just prior to first dose) to 24 hours post first dose|Subjects who received at least one dose of IV acetaminophen and had at least 3 PK sampling assessments were included in the PK analysis.This outcome measure represents PK parameters for the first dose of IV acetaminophen.||micrograms per milliliter (µg/mL)||Full Range|Median
137344|NCT00493220|Primary|AUC0-inf|Area under the drug concentration-time curve from time zero to infinity, calculated as AUC0-t + Ct/kel (Ct = time of last measurable concentration; kel = terminal elimination rate constant)|from the start of ceftriaxone administration to infinity|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||µg*hr/mL||Standard Deviation|Mean
137345|NCT00493220|Primary|AUC0-t|Area under the drug concentration-time curve from time zero to the time of the last measurable concentration (calculated by the linear trapezoidal method)|Start of ceftriaxone administration through time of last measureable plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||μg*hr/mL||Standard Deviation|Mean
137346|NCT00493220|Secondary|Tmax|Time to maximum measured plasma ceftriaxone concentration|from start of ceftriaxone administration until time of maximum measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||hr||Full Range|Median
137347|NCT00493220|Secondary|Cmax|Maximum measured plasma ceftriaxone concentration|at the time of the highest measured plasma ceftriaxone concentration|Per protocol (excludes one participant that did not receive intravenous ceftriaxone intervention)||µg/mL||Standard Deviation|Mean
137348|NCT00493181|Primary|Number of Participants With Complete Response|Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (>/= 3 months) platelet count >/= 60 x 10^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.|Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)|||Participants|||Number
137349|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|End of Follow-up, Day 24-30 after treatment|Patients valid per protocol with a causative organism cultured.||Participants|||Number
137350|NCT00493038|Secondary|Number of Participants With Response (Microbiologically Valid Patients)|Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.|At 'Test-of-Cure', Day 1-3 after treatment|Patients valid per protocol with a causative organism cultured.||Participants|||Number
137351|NCT00493038|Secondary|Number of Participants With Response (Per-protocol Population)|Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as “continued clinical cure”|End of Follow-up, Day 24-30 after treatment|PP population at end FU: (1) Clinical evaluation was performed at the TOC visit (2) No other systemic antibacterial agent was administered with study drug up to the TOC visit (3) Adequate treatment compliance (≥80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy (6) FU assessment available||participants|||Number
137352|NCT00493038|Secondary|Number of Participants With Response (Intent-to-treat Population)|Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as “clinical cure”|At 'Test-of-Cure', Day 1-3 after treatment|ITT population: participants having at least one observation under study medication||participants|||Number
137429|NCT00492297|Secondary|Duration of Partial Response|Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed PR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 9 subjects who had a PR were included in this analysis.||days||95% Confidence Interval|Median
137353|NCT00493038|Primary|Number of Participants With Response (Per-protocol Population)|Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as “clinical cure”|At 'Test-of-Cure', Day 1-3 after treatment|Per Protocol population: subjects to meet all of the following (1) Clinical evaluation was performed at TOC visit (2) No other systemic antibacterial agent was administered with study drug up to TOC visit (3) Adequate treatment compliance (≥ 80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy||participants|||Number
137354|NCT00493012|Secondary|Hb A1c||change from baseline to 12 months|||% glycosylated hemoglobin||Standard Deviation|Mean
137355|NCT00493012|Secondary|Proinsulin||change from baseline to 12 months|||pmol/l||Standard Deviation|Mean
137356|NCT00493012|Secondary|Tumor Necrosis Factor Alpha||change from baseline to 12 months|||pg/ml||Standard Deviation|Mean
137357|NCT00493012|Secondary|C-reactive Protein||change from baseline to 12 months|||mg/l||Standard Deviation|Mean
137358|NCT00493012|Secondary|LDL-cholsterol||change from baseline to 12 months|||mmol/l||Standard Deviation|Mean
137359|NCT00493012|Secondary|Triglycerides||change from baseline to 12 months|||mmol/l||Standard Deviation|Mean
137360|NCT00493012|Secondary|Parathyroid Hormone||change from baseline to 12 months|||pmol/l||Standard Deviation|Mean
137361|NCT00493012|Secondary|Calcitriol||change from baseline to 12 months|||pmol/l||Standard Deviation|Mean
137362|NCT00493012|Secondary|25-hydroxyvitamin D||change from baseline to 12 months|||nmol/l||Standard Deviation|Mean
137363|NCT00493012|Secondary|Fat Mass||parameter change from baseline to 12 months|||kg||Standard Deviation|Mean
137364|NCT00493012|Primary|Body Weight||change in body weight from baseline to 12 months|||kg||Standard Deviation|Mean
137365|NCT00492973|Primary|Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.||any point during the first postoperative year|||Number of participants with complication|||Number
137366|NCT00492973|Primary|Patient Satisfaction||6 weeks, 3 months, and 1 year postoperative||||||
137367|NCT00492973|Primary|Amount of Pain Medication Taken Per Day||Average of 3 days after surgery|||mg/day morphine equivalant||Standard Deviation|Mean
137368|NCT00492973|Primary|Knee Society Scores|The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.|3 months postoperative|||units on a scale||Standard Deviation|Mean
137369|NCT00492973|Primary|Knee Range of Motion||3 months|||degrees||Standard Deviation|Mean
137370|NCT00492973|Primary|Length of Hospital Stay||days after surgery|||days||Standard Deviation|Mean
137371|NCT00492856|Primary|3-year Disease-free Survival (DFS) Rate|DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient > 10^-5 based on RT-PCR performed at appropriate central lab.|Up to 3 years|Eligible patients in molecular remission after receiving consolidation and randomized to either maintenance chemotherapy or observation. As of 8/15/10, all eligible patients were non-randomly assigned to receive maintenance chemotherapy. Only those that were randomized to either maintenance treatment or observation were included.||percentage of patients|||Number
137372|NCT00492856|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.||Participants|||Number
137373|NCT00492752|Secondary|Time of Maximum Concentration (Tmax) After 21 Days of Sorafenib Treatment|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||hours||Full Range|Median
137374|NCT00492752|Secondary|Normalized Maximum Concentration (Cmaxnorm) After 21 Days of Sorafenib Treatment|Cmaxnorm refers to the maximum plasma concentration of Sorafenib corrected for dose and body weight (Cmaxnorm = Cmax/(mg/kg)).|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||g/mL||Full Range|Geometric Mean
137375|NCT00492752|Secondary|Maximum Concentration (Cmax) After 21 Days of Sorafenib Treatment|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||mg/L||Full Range|Geometric Mean
137376|NCT00492752|Secondary|Normalized Area Under the Curve (AUC Norm) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||g*h/L||Full Range|Geometric Mean
137377|NCT00492752|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) After 21 Days of Sorafenib Treatment|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1|The stated goal in the protocol was to obtain PK data from approximately 39 patients. As this was only descriptive information, the sample size was not critical. All patients who provided PK data were included in the analysis.||mg*h/L||Full Range|Geometric Mean
137378|NCT00492752|Secondary|Time to Response|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) ) was defined as the time from date of randomization to the earliest date that the response was first documented.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The time to response was measured for the ITT population.||days||Full Range|Median
137379|NCT00492752|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented, or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last tumor assessment.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|The duration of response was measured for the ITT population.||days||Full Range|Median
137380|NCT00492752|Secondary|Number of Participants With Different Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed* Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization/start of treatment of the first subject until approximately 23 months after randomization when the subjects on placebo were offered the option to crossover to sorafenib treatment|The tumor response was measured for the ITT population.||participants|||Number
137381|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Score From Baseline to Cycle 3 and End of Treatment|"The FACT-Hep questionnaire was also completed to assess patient reported outcome. The FACT-Hep assesses hepatobiliary cancer-related quality of life. FACT-Hep total score ranges from 0 to 180 (0=All questions answered Not at all; 180=All questions answered Very much)."|Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FACT-Hep score changes from baseline by visit were assessed for the ITT population.||scores on a scale||Standard Deviation|Mean
137382|NCT00492752|Secondary|Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) Score From Baseline to Cycle 1 and Cycle 3|The FHSI-8 questionnaire was completed at baseline and every 3 weeks during treatment and at the end of treatment visit only for subjects who withdrew for reasons other than symptomatic progression. Patient reported outcome was measured using the FHSI-8 score changes from baseline throughout the study period. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms)..|Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|FHSI-8 score changes from baseline by visit were assessed for the ITT population.||scores on a scale||Standard Deviation|Mean
137383|NCT00492752|Secondary|Disease Control|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD: an increase in the sum of tumor lesions sizes) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR: disappearance of tumor lesions) + total number of Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes) + total number of Stable Disease (SD: steady state of disease); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating).|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Disease control rate was measured for the ITT population (all randomized subjects)||participants|||Number
137384|NCT00492752|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to radiologically documented disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation。|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of 09 Aug 2007 (23 months after randomization).||days||95% Confidence Interval|Median
137385|NCT00492752|Secondary|Time to Symptomatic Progression (TTSP)|Time to Symptomatic Progression (TTSP) was defined as the time from date of randomization to symptomatic progression. Subjects without symptomatic progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|Time to Symptomatic Progression was measured for the ITT population (all randomized subjects) up to the data cut-off date of of 09 Aug 2007 (23 months after randomization)||days||95% Confidence Interval|Median
142355|NCT00448630|Primary|Metabolic Syndrome Parameter Triglycerides|Iterative measurement of triglycerides. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
137386|NCT00492752|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 09 Aug 2007 (23 months after randomization).||days||95% Confidence Interval|Median
137387|NCT00492726|Secondary|Duration of Hospitalization Postoperatively|Duration of hospitalization after the first surgery until discharge in the per protocol population.|Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.||days||Standard Deviation|Mean
137388|NCT00492726|Secondary|Duration of Hospitalization|Duration of hospitalization in the per protocol population.|From the first admission date to the discharge date (from 4 to 71 days after start of study medication)|Numbers refer to patients in the per protocol population with known end of hospitalization date.||days||Standard Deviation|Mean
137389|NCT00492726|Secondary|Number of Subjects Who Died Due to Intra-abdominal Infections|Number of subjects who had died due to intra abdominal infections by the time of TOC visit.|21 - 28 days after end of treatment at TOC Visit|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
137390|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).||participants|||Number
137391|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’ – additionally, any recurrence or reinfection was treated as bacteriological failure at TOC.|21 - 28 days after end of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).||participants|||Number
137392|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.|After 5 - 14 days of therapy|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s). For one patient in the Moxifloxacin group, the data is missing due to missing EOT visit (not displayed in the table below).||participants|||Number
137393|NCT00492726|Secondary|Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population|Clinical cure = resolution/improvement of clinical signs and symptoms related to the infection without wound infection requiring systemic antibiotic treatment. Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|after 5 - 14 days of therapy|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
137394|NCT00492726|Secondary|Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)|Bacteriological success = response classified as ‘eradication’ or ‘presumed eradication’ without occurrence of a superinfection. Bacteriological failure = response classified as ‘persistence’, ‘presumed persistence’, or ‘superinfection’.|During treatment at day 5 +/- 1 day|Per protocol population (subjects with no major protocol deviations that would have influenced the primary outcome) with causative organism(s).||participants|||Number
137395|NCT00492726|Secondary|Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population|Clinical improvement = Reduction in the severity and/or number of signs and symptoms of infection.Clinical failure = Failure to respond/insufficient lessening of signs and symptoms of infection requiring a modification/addition of antibacterial therapy, or a second surgical intervention (unless the original surgery was deemed inadequate). Development of a wound infection requiring alternative/additional antibiotic therapy was considered a failure. Failed subjects must have had 3 full days of therapy administered.|During treatment at day 5 +/- 1 day|Per protocol population comprising subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
137396|NCT00492726|Primary|Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.|21 to 28 days after completion of study drug therapy|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subjects with no major protocol deviations that would have influenced the primary outcome.||participants|||Number
137397|NCT00492583|Primary|Number of Days Children Are Out of School Sick|"Outcome measure, number of days children are out of school sick was measured for the entire population"|90 days|||days per 100 person days|||Number
137398|NCT00492557|Post-Hoc|13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of a subset of participants using a microcolony OPA (mcOPA) assay.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. n= number of participants with a determinate OPA antibody titer to the given serotype.||Geometric mean titers||95% Confidence Interval|Geometric Mean
137399|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events|Systemic events (Any fever >= 38 degrees Celsius [C]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category.|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.||Percentage of participants|||Number
137400|NCT00492557|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder).|Days 1 through 14 after 13vPnC vaccination|Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively.||percentage of participants|||Number
137401|NCT00492557|Primary|13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)|IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.||mcg/mL||95% Confidence Interval|Geometric Mean
137402|NCT00492557|Primary|TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)|Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.|Baseline and 1 month after TIV vaccination|Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
137403|NCT00492544|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|"Abnormalities include values outside (above or below) the normal ranges.~Normal ranges:~alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL"|At Day 0 and Month 7|||subjects|||Number
137404|NCT00492544|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|||subjects|||Number
137405|NCT00492544|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7|||subjects|||Number
137406|NCT00492544|Secondary|Outcome of All Pregnancies|According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.|Up to Month 7|There were no pregnancies reported between Day 0 and Month 7 in the Total Vaccinated Cohort.|||||
137407|NCT00492544|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.|From Day 0 up to Month 7|||subjects|||Number
137408|NCT00492544|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination|||subjects|||Number
137409|NCT00492544|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day (Days 0-6) period following each vaccination|||subjects|||Number
137410|NCT00492544|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers|Titers are given as geometric mean titers (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.||titer||95% Confidence Interval|Geometric Mean
137411|NCT00492544|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
137712|NCT00489853|Secondary|Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liter||Standard Deviation|Mean
137412|NCT00492531|Primary|Change in Exercise Capacity as Assessed by 6 Minute Walk.|The primary outcome measure was change in exercise capacity assessed by 6 minute walk distance in meters from baseline to 16 weeks. Subjects without a week 16 assessment had their last observation carried forward.|Baseline to week 16/Imputed last visit.|All efficacy and safety analyses were conducted on the intent-to-treat (ITT) population, defined as all randomized subjects, regardless of therapy received. Pre-defined imputation rules:A value of 0 meters was imputed for subjects who died during the MIT.Subjects without a week 16 assessment had their last observation carried forward (LOCF).||meters||Standard Deviation|Mean
137413|NCT00492531|Secondary|Brain Natriuretic Peptide(BNP)Levels.||16 weeks|||pg/dl||Standard Deviation|Mean
137414|NCT00492531|Secondary|Borg Dyspnea Score|Borg dyspnea score was used to measure the level of severity of breathlessness perceived by the patient before and after 6 minute walk. The severity is measured on a 10 point scale with 0= nothing at all and 10=maximum severity of breathlessness.|baseline to 16 weeks|||Score on a scale||Standard Deviation|Mean
137415|NCT00492531|Secondary|Change From Baseline in Pulmonary Hypertension at Week 16 as Assessed by Tricuspid Regurgitant Jet Velocity|Secondary outcome measure was change from baseline in Pulmonary hypertension at week 16 as assessed by Tricuspid regurgitant jet velocity(TRV). Tricuspid regurgitant jet velocity was measured by transthoracic Doppler Echocardiography.|16 weeks|||meters/second||Standard Deviation|Mean
137416|NCT00492401|Secondary|Measurement of Gene Expression in Peripheral Blood or Bone Marrow|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed for this trial|||||
137417|NCT00492401|Secondary|Measurement of HbF in Peripheral Blood or Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to days 28 of course 2|Data was not collected and analyzed for this trial|||||
137418|NCT00492401|Secondary|Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells|Expression studies were conducted using quantitative RT PCR. Expression of DNMT were normalized to the internal control to the ABL and levels of miR-29 to RNA U44.|Pre treatment|Only pre treatment samples available for testing for 23 patients||delta delta CT values||Inter-Quartile Range|Median
137419|NCT00492401|Secondary|Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells|Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.|From baseline to up to day 28 of course 1|Data was not collected and analyzed|||||
137420|NCT00492401|Primary|Rate of Complete Remission|Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul. Complete Remission Rate (CRm + CRi)|Up to 24 weeks|||patients|||Number
137421|NCT00492336|Secondary|Side Effect Checklist and Vital Signs||Weekly||||||
137422|NCT00492336|Secondary|Simpson Angus Scale||Every 4 weeks||||||
137423|NCT00492336|Secondary|Neuropsychological Tests, Including RBANS, Probabilistic Learning Task, and N-Back Task||Beginning of treatment phase (week 0) and end of treatment phase (week 12)||||||
137424|NCT00492336|Primary|Scale for the Assessment of Negative Symptoms (SANS)|"Scores on the subscales are combined (summed) to compute a total score. There are a total of 17 subscales. Each subscale ranges from 0=Not at all to 5=Severe. Every 4 weeks the summed subscale scores provide a total score for that week (0-85). These total scores from each week are then combined (summed) for an overall score and then averaged for the two groups after the 12 week period."|Every 4 weeks over a 12 week period|||units on a scale||Standard Deviation|Mean
137425|NCT00492297|Secondary|Time to Progression|Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD.|From start of treatment until progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Of these 83, 78 were included in this analysis.||days||95% Confidence Interval|Median
137426|NCT00492297|Secondary|Time to Response|Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented.|start of therapy to confirmed CR or PR (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.||days||95% Confidence Interval|Median
137427|NCT00492297|Secondary|Duration of Stable Disease|Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment.|from start of therapy to PD, only in non-responders (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 70 subjects who had a Best Response of Stable Disease, ie, those who failed to achieve a Best Response of CR or PR, were included in this analysis.||days||95% Confidence Interval|Median
137428|NCT00492297|Secondary|Disease Control (DC)|DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point.|after start of treatment, at 6 months and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||participants|||Number
138285|NCT00485732|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
137430|NCT00492297|Secondary|Duration of Complete Response|Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes).|from confirmed CR until PD (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 1 subject who had a CR was included in this analysis (duration 420 days, censored).||days|||Number
137431|NCT00492297|Secondary|Duration of Response|Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment.|from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis.||days||Full Range|Median
137432|NCT00492297|Secondary|Overall Survival|Overall Survival was the number of days from the date that combination treatment started until the date of death.|from start of treatment until death (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||days||95% Confidence Interval|Median
137433|NCT00492297|Secondary|Percentage of Subjects With Progression-free Survival at Specific Time-points|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression after 3, 6 and 12 months|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||percentage of participants|||Number
137434|NCT00492297|Secondary|Progression-free Survival|Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.|from start of treatment until progression or death before progression (median 259 days)|There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis.||days||95% Confidence Interval|Median
137435|NCT00492297|Primary|Overall Best Response|Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions.|during or within 30 days after active therapy|There were 83 subjects in the intent-to-treat (ITT) population. Of these, 75 were evaluable for Best Response; 8 were not evaluable.||participants|||Number
137436|NCT00492284|Secondary|Mean Change From Baseline in Lesion Size|Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion|Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||micron||Standard Deviation|Mean
137437|NCT00492284|Secondary|Mean Change From Baseline in Central Retinal Thickness||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||micron||Standard Deviation|Mean
137438|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||Percentage of participants||95% Confidence Interval|Mean
137439|NCT00492284|Secondary|Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||Percentage of participants||95% Confidence Interval|Mean
137440|NCT00492284|Secondary|Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline||Baseline to Month 12, Baseline to Month 24|Intent-to-treat and last observation carried forward||Percentage of participants||95% Confidence Interval|Mean
137441|NCT00492284|Secondary|Mean Change From Baseline in Study Eye Best-Corrected VA Score|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 24|||Letters read on ETDRS chart||95% Confidence Interval|Mean
137442|NCT00492284|Secondary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 24|Intent-to-treat||number of retreatments||95% Confidence Interval|Mean
137443|NCT00492284|Primary|Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)|Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100|Baseline to Month 12|Intent-to-treat and last observation carried forward||Letters read on ETDRS chart||95% Confidence Interval|Mean
137444|NCT00492284|Primary|Mean Number of Retreatments (Day 0 Excluded)|Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.|Month 1 to Month 12|Intent-to-treat||number of retreatments||95% Confidence Interval|Mean
137492|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD57cells||Standard Deviation|Mean
137445|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage at any previously defined 2-week period (ie, reduction phase) during the DBTP were summarized. The reduction in dosage at any time=[1-(reduction phase weekly dosage/baseline weekly dosage)]*100%.|Baseline and Weeks 1-10|Analysis was performed on all subjects who were randomized and received at least 1 dose of double-blind medication during the study. Subjects were analyzed by the treatment they were randomized to receive.||participants|||Number
137446|NCT00492232|Secondary|Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period|Participants who achieved a 50% reduction in zolpidem dosage (or frequency) at the end of the DBTP (ie, the end of Reduction Phase 4) were summarized. The reduction in dosage at Reduction Phase 4=[1-(Reduction Phase 4 weekly dosage/baseline weekly dosage)]*100%.|Baseline and Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||participants|||Number
137447|NCT00492232|Secondary|Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation|Participants who took no zolpidem during the last 7 days of the DBTP were completely discontinued from zolpidem. Participants who completely discontinued zolpidem via reduction in zolpidem use frequency (alone) were not summarized.|Weeks 1-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, had completed the DBTP, and had sufficient zolpidem dosage data in the last 7 days of the DBTP. Estimates could not be reported with correct statistical inference due to small sample sizes by method of discontinuation (ie, most subjects reduced zolpidem dose).||participants|||Number
137448|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10|The number of nights zolpidem was taken was recorded during Weeks 9-10 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
137449|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8|The number of nights zolpidem was taken was recorded during Weeks 7-8 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
137450|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6|The number of nights zolpidem was taken was recorded during Weeks 5-6 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
137451|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4|The number of nights zolpidem was taken was recorded during Weeks 3-4 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from baseline were summarized.|Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
137452|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2|The number of nights zolpidem was taken was recorded during Weeks 1-2 of the DBTP. Weekly frequency was calculated as the number of nights zolpidem was taken divided by the number of days within the period, multiplied by 7. Differences in frequency from BL were summarized.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||nights per week||Standard Error|Least Squares Mean
137453|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10|Dosages of zolpidem taken were recorded during Weeks 9-10 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 9-10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
137454|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8|Dosages of zolpidem taken were recorded during Weeks 7-8 of the double blind period. Differences in dosages from baseline were summarized.|Baseline and Weeks 7-8|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
137455|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6|Dosages of zolpidem taken were recorded during Weeks 5-6 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 5-6|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
137456|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4|Dosages of zolpidem taken were recorded during Weeks 3-4 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 3-4|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
137457|NCT00492232|Secondary|Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2|Dosages of zolpidem taken were recorded during Weeks 1-2 of the DBTP. Differences in dosages from baseline were summarized. Weekly dosage was calculated as total amount of zolpidem taken divided by the number of days within the phase, multiplied by 7.|Baseline and Weeks 1-2|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Dose (mg)||Standard Error|Least Squares Mean
137458|NCT00492232|Primary|Percentage of Participants Who Discontinued Zolpidem Therapy|Participants reduced zolpidem incrementally from Week 3 to Week 10 of the double-blind treatment period (DBTP). A participant who did not take any zolpidem during the last 7 days of the DBTP was defined as having completely discontinued zolpidem by that time point. The number of subjects who discontinued zolpidem at the end of the DBTP was summarized.|Week 10|Analysis was performed on all randomized subjects who took at least 1 dose of study drug, who had completed the DBTP, and who had sufficient zolpidem dosage data in the last 7 days of the DBTP.||Percentage of participants|||Number
137459|NCT00492206|Secondary|EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase|EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.|approx. 5 years|Participants with baseline tumor tissue available for EGFR status analysis by fluorescence in situ hybridization (FISH). Akt, pAkt, and MAPKinase analyses were not conducted.||percentage of tumors|baseline tumor tissue||Number
137460|NCT00492206|Secondary|Best Overall Response Rate (ORR) (Number of Participants)|The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 12 weeks after treatment initiation|Patients who received concurrent radiotherapy + cetuximab + consolidation therapy, and patients who did not receive cetuximab||participants|||Number
137461|NCT00492206|Secondary|Progression-free Survival (PFS)|Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC.||months||95% Confidence Interval|Median
137462|NCT00492206|Primary|Overall Survival (OS)||Up to 36 months|Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC (N = 38).||months||95% Confidence Interval|Median
137463|NCT00492089|Primary|Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment|Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.|Baseline to 12 weeks|Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.||participants|||Number
137464|NCT00492063|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination|The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.|Up to 7 days postvaccination|Analysis was done on Safety population i.e., all subjects with vaccination and with some post-baseline safety data.||Number of Subjects|||Number
137465|NCT00492063|Primary|Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV|Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.||Ratio||95% Confidence Interval|Number
137466|NCT00492063|Primary|Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV|Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.|Three weeks after vaccination (day 22)|Analysis was performed on the PP set.||Percentages||95% Confidence Interval|Number
137467|NCT00492063|Primary|Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines|"Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.~In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group."|Before vaccination (day 1) and three weeks after vaccination (day 22)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccination correctly; provided evaluable data before and after vaccination; and with no major protocol violations, as defined before unblinding.||Percentages||95% Confidence Interval|Number
137525|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
137468|NCT00492024|Other Pre-specified|Percentage of Subjects With Clinical Cure (Per Protocol Population (PP))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure', Day 1-5 after end of treatment|This analysis population was per protocol population, which included all subjects with at least one pre-treatment causative organism, and who had no major deviations from the protocol procedures.||Percentage of subjects|||Number
137469|NCT00492024|Secondary|Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up|A secondary efficacy variable was clinical response (CR) at the Follow-up visit 17-21 days following the start of treatment. CR was rated as continued cure, failure/relapse, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 12 to 26 after end of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||Percentage of subjects|||Number
137470|NCT00492024|Secondary|Percentage of Subjects With Clinical Improvement During Therapy|A secondary efficacy variable was clinical response (CR) at the During Therapy visit at day 3 or 4 of treatment. CR was rated as improvement, cure, failure, or indeterminate. Clinical evaluation was based on the presence and severity (mild, moderate, or severe) of several signs and symptoms of acute sinusitis.|Day 3 of treatment|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism. Missing responses at during therapy visit in most cases was due to early clinical failure.||Percentage of subjects|||Number
137471|NCT00492024|Secondary|Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach|The Activity Impairment Assessment (AIA) questionnaire was used to assess activity impairment at baseline and time to return to normal activities. The AIA was administered prior to first dose, every 24 hours during treatment, and at the TOC visit. Improvement in the AIA total score was defined as a decrease of at least 3 units.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||participants|||Number
137472|NCT00492024|Secondary|Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach|The Sino-Nasal Outcome Test (SNOT-16) was used to assess subject-reported time to symptom improvement. Improvement was defined as a decrease of at least 14 units on the test. This difference is the smallest difference that has been identified as beneficial to subjects.|Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment)|The MITT population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||participants|||Number
137473|NCT00492024|Primary|Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT))|The primary efficacy variable was clinical response (CR) at the TOC visit, and was rated as improvement, complete resolution, failure, or indeterminate. Clinical cure, ie, success, was defined as complete resolution or improvement in the signs and symptoms such that no further therapy (antimicrobial, steroid, or irrigation) was required.|At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment|The modified intent-to-treat (MITT) population was the primary analysis population. This population includes all subjects treated with at least one dose of study medication, and who have at least one pre-treatment causative organism.||Percentage of subjects|||Number
137474|NCT00491894|Secondary|Investigator's Global Assessment of Treatment|The investigator performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The investigator selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’ (neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for investigator's Global Assessment was done by intention to treat method||Participants|||Number
137475|NCT00491894|Secondary|Parent/Caregiver's Global Assessment of Treatment|The parent/caregiver performed an overall evaluation of glycopyrrolate liquid for the treatment of drooling, benefits, and side effects over the duration of the study. The parent/caregiver selected one of the following choices to assess if ‘This is a worthwhile treatment’: 1 = strongly agree, 2 = agree, 3 = neutral, 4 = disagree, 5 = strongly disagree. A dichotomous global assessment was also performed and summarized with the categories ‘responder’ (strongly agree and agree responses aggregated) and ‘non-responder’(neutral, disagree, and strongly disagree responses aggregated)|Week 24|The analysis for parent/caregiver's Global Assessment was done by intention to treat method||Participants|||Number
137476|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using VAS|Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.|Week 24|||VAS score||Standard Deviation|Mean
137477|NCT00491894|Secondary|Parent/Caregiver's Assessment of the Extent of Drooling Using Visual Analog Scale (VAS)|Parents/caregivers were to complete a 10 cm “Parent/Caregiver’s Assessment of Extent of Drooling for the Day” VAS assessment (0 = normal; 10 = extremely wet) to provide an overall assessment of the extent of drooling for that day.|Baseline|||VAS score||Standard Deviation|Mean
137478|NCT00491894|Primary|Proportion of Responders According to the Modified Teacher’s Drooling Scale (mTDS)|The primary efficacy variable was patient's response status using the change from baseline to Week 24 evaluations of the mTDS assessment. Each patient was classified as a responder or non-responder according to the change in their mean mTDS rating from baseline to Week 24. Responders were patients who had at least a 3-point decrease in mTDS rating from baseline|6 months|The analysis was done by intention to treat method. For purposes of statistical estimation, patients who dropped out due to lack of efficacy had their worst observation carried forward. Patients who dropped out for reasons other than lack of efficacy had their last observation carried forward||Participants|||Number
137479|NCT00491829|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered “yes” to the eDiary question: “Was the event satisfying for you?”|baseline to 24 weeks|Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses.||events per month||Standard Deviation|Mean
137480|NCT00491764|Secondary|Treatment Success of Onychomycosis at Week 48|Treatment success was defined as negative mycology (negative culture and negative KOH) and =<10% nail involvement.|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication||Participants|||Number
137481|NCT00491764|Secondary|Effective Treatment of Onychomycosis at Week 48.|Effective treatment is defined as negative mycology (negative culture and KOH) and either 0% nail involvement or >5 mm growth of unaffected nail|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication||Participants|||Number
137482|NCT00491764|Primary|Complete Cure of Onychomycosis at Week 48.|Complete cure is defined as negative mycology (negative culture and KOH [potassium hydroxide]) and 0% nail involvement (defined as absence of onycholysis and subungual hyperkeratosis).|Measured at Day 1, Week 2, Week 4, and Every 4 Weeks Thereafter Until Week 48|This analysis was based on all randomized subjects who had a baseline assessment and at least one post-baseline assessment available, and who had been exposed to at least one dose of study medication||Participants|||Number
137483|NCT00491738|Primary|All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)|Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.|5 months|||participants|||Number
137484|NCT00491608|Secondary|Number of Participants With Clinically Significant Changes in Mean Values for Vital Signs (Temperature, Systolic Blood Pressure, Diastolic Blood Pressure, Respiration Rate, Heart Rate) at Baseline and Day 29|Laboratory findings considered clinically significant by investigator when associated with symptoms, required specific treatment, or required a change in participant management. Clinically significant changes in vital signs were reported as adverse events.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery.||Participants|||Number
137485|NCT00491608|Secondary|Number of Participants With Abnormal Laboratory Results in Median Levels of Immunoglobulin A, G, and M at Baseline or Day 29|Abnormal laboratory findings were recorded as AEs when the investigator considered them to be clinically significant (eg, an unusual result for the surgical population or for an individual participant) or when they were associated with symptoms or required treatment or a change in patient management.|Baseline and Day 29 (end of study)|All participants who received rThrombin and had both baseline and postbaseline antibody assessments available.||Participants|||Number
137486|NCT00491608|Secondary|Number of Participants With Elevations in Coagulation Parameters of CTC Grade 3 or Higher at Baseline and Day 29|Activated partial thromboplastin time (aPTT) elevations: Grade 3=>2*upper limit of normal (ULN). International normalized ratio(INR)elevations: Grade 3=>2*ULN. Changes in prothrombin time were not graded for toxicity. n=Number of participants with assessments available at that visit.|Baseline and Day 29 (end of study)|All participants who received at least 1 application of rThrombin during surgery and had laboratory test results available for assessment.||Participants|||Number
137487|NCT00491608|Secondary|Number of Participants With Abnormal Hematology Laboratory Results of Common Terminology Criteria (CTC) Grade 2 or Higher at Baseline and Day 29|Hemoglobin, low (g/L): Grade 2=<100 Grade 3=<80; Grade 4=<65. Platelets, low: Grade 2=<75*10^9/L; Grade 3=<50*10^9/L; Grade 4=<25*10^9/L. Leukocytes, low: Grade 2=<3.0-2.0*10^9/L; Grade 3=<2.0-1.0*10^9/L; Grade 4=<1.0*10^9/L. Lymphocytes, low: Grade 2=<0.8*10^9/L; Grade 3=<0.5*10^9/L; Grade 4=<0.2*10^9/L. Neutrophils, low: Grade 2=<1.5*10^9/L; Grade 3=<1.0*10^9/L; Grade 4=<0.5*10^9/L. Changes in hematocrit values observed were not graded for severity.|Baseline and Day 29 (end of study)|All participants who who received at least 1 application of rThrombin during surgery and had laboratory test results available for baseline and Day 29 visits.||Participants|||Number
137488|NCT00491608|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, Treatment-related Adverse Events (AEs), and Treatment-emergent AEs|AE=a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE=an unfavorable medical event that results in death, persistent or significant incapacity, or drug dependency or abuse; is life-threatening, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to study drug. Treatment-emergent=onset on or after treatment start. Grade (Gr) 1=mild, Gr 2=moderate, Gr 3=severe, Gr 4=life threatening/disabling, Gr 5=death.|Day 1 (surgery) to Day 29 (end of study), continuously|All participants who received at least 1 application of rThrombin during surgery.||Participants|||Number
137489|NCT00491608|Primary|Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline|Seropositive=with specific anti-bovine thrombin product antibodies; seronegative=without specific anti-bovine thrombin product antibodies.|At Day 29|Participants who received treatment with rThrombin and had results from both baseline and post-baseline antibody assessments||Participants|||Number
137490|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
137491|NCT00491556|Secondary|Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa HLA-DR T cells||Standard Deviation|Mean
137493|NCT00491556|Secondary|Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD57 cells||Standard Deviation|Mean
137494|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
137495|NCT00491556|Secondary|Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD38 cells||Standard Deviation|Mean
137496|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRa CD28 cells||Standard Deviation|Mean
137497|NCT00491556|Secondary|Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Three subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 22 participants.||percentage of CD8 TemRA CD28 cells||Standard Deviation|Mean
137498|NCT00491556|Secondary|Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo HLA-DR cells||Standard Deviation|Mean
137499|NCT00491556|Secondary|Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRO HLADR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRO HLADR||Standard Deviation|Mean
137500|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
137501|NCT00491556|Secondary|Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD57 cells||Standard Deviation|Mean
137502|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
137503|NCT00491556|Secondary|Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD38 cells||Standard Deviation|Mean
137504|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
137505|NCT00491556|Secondary|Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TEMRo CD28 cells||Standard Deviation|Mean
137506|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
137507|NCT00491556|Secondary|Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM HLA-DR T cells||Standard Deviation|Mean
137508|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
137555|NCT00491244|Primary|Sustained Virologic Response (SVR)Rate||1.5 year|All participants were analyzed if they received at least one dose of the study medication||participants|||Number
137509|NCT00491556|Secondary|Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD57 cells||Standard Deviation|Mean
137510|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
137511|NCT00491556|Secondary|Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD38 cells||Standard Deviation|Mean
137512|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
137513|NCT00491556|Secondary|Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 TCM CD28 cells||Standard Deviation|Mean
137514|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing HLA-D, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve HLA-DR T cells||Standard Deviation|Mean
137515|NCT00491556|Secondary|Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing Human Leukocyte Antigen-D related (HLA-DR), therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve HLA-DR T-cells||Standard Deviation|Mean
137516|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
137517|NCT00491556|Secondary|Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD57 cells||Standard Deviation|Mean
137518|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
137519|NCT00491556|Secondary|Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD38 cells||Standard Deviation|Mean
137520|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 Naïve CD28 Cells||Standard Deviation|Mean
137521|NCT00491556|Secondary|Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.||percentage of CD8 naïve CD28 cells||Standard Deviation|Mean
137522|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
137523|NCT00491556|Secondary|Difference in CD8+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
137524|NCT00491556|Secondary|Difference in CD8+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TEMRo cells/cubic millimeter||Standard Deviation|Mean
137526|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
137527|NCT00491556|Secondary|Difference in CD8+ TCM Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ TCM cells/cubic millimeter||Standard Deviation|Mean
137528|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ naïve T cells/cubic millimeter||Standard Deviation|Mean
137529|NCT00491556|Secondary|Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD8+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
137530|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
137531|NCT00491556|Secondary|Difference in CD4+ TEMRa Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TEMRa cells/cubic millimeter||Standard Deviation|Mean
137532|NCT00491556|Secondary|Difference in CD4+ TEMRo Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
137533|NCT00491556|Secondary|Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ Effector Memory (TEM)Ro count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TemRo cells/cubic millimeter||Standard Deviation|Mean
137534|NCT00491556|Secondary|Difference in CD4+ TCM Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
137535|NCT00491556|Secondary|Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Termed Central Memory (TCM) count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ TCM cells/cubic millimeter||Standard Deviation|Mean
137536|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
137537|NCT00491556|Secondary|Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.||CD4+ naïve t-cells/cubic millimeter||Standard Deviation|Mean
137538|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 48 and Week 152||152 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
137539|NCT00491556|Secondary|Difference in CD4+ T Cell Count Between Week 0 and Week 48||48 weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.||CD4+ T cells/cubic millimeter||Standard Deviation|Mean
137540|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 48 and Week 152||152 Weeks|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm||percentage of CD4+ T cells||Standard Deviation|Mean
137541|NCT00491556|Primary|Difference in CD4+ T Cell Percentage Between Week 0 and Week 48||Week 0 and Week 48|Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized to the experimental arm.||percentage of CD4+ T cells||Standard Deviation|Mean
137542|NCT00491530|Secondary|Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Total-C minus baseline Total-C)/baseline Total-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
137543|NCT00491530|Secondary|Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
137544|NCT00491530|Secondary|Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
137545|NCT00491530|Secondary|Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Standard Deviation|Mean
137546|NCT00491530|Secondary|Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at week 104 are included.||percent change||Standard Deviation|Mean
137547|NCT00491530|Secondary|Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study|[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides] X 100. Baseline is the last value prior to the first dose of combination therapy.|Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. Only subjects with a combination therapy baseline value and postbaseline value at Week 104 are included.||percent change||Full Range|Median
137548|NCT00491530|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study|All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.|Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or preceding open-label year 1 study, and in this open-label year 2 study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.||percentage of participants|||Number
137549|NCT00491504|Primary|Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1|Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time.|Baseline and 6 hours following initial dosing|Intent to treat population||score on a scale||Standard Error|Least Squares Mean
137550|NCT00491400|Secondary|Serum Lipids|Effect of the intervention on total cholesterol, HDL, and triglycerides|8 weeks|Enrollment was insufficient and there are too few subjects for meaningful analysis|||||
137551|NCT00491400|Primary|Brachial Artery Flow-mediated Dilation|Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.|8 weeks|The number of participants is too few for meaningful analysis.|||||
137552|NCT00491387|Primary|Improved Sympathetic Cardiac Innervation.||6 months|||participants|||Number
137553|NCT00491374|Primary|The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI)|||The primary outcome measure could not be assessed because no subject received randomized treatment assignment, or any treatment. The study was terminated.|||||Number
137554|NCT00491244|Secondary|Adverse Event (AE)-Related Withdrawal Rate||1.5 year|All patients were analyzed if they received at least one dose of the study medication; monitoring the events until the last visit||participants|||Number
137556|NCT00491179|Secondary|Number of Participants With Histologic Response(HR)|Number of participants with histologic response (HR): number of patients who had improvement of as least 2 scores at the end of follow-up liver biopsy compared to baseline liver biopsy by Ishak scoring system (the sum of Ishak necroinflammation score (0-18) and Ishak fibrosis score (0-6); the higher the total scores, the severer the histologic changes)|1.5 year|||Participants|||Number
137557|NCT00491179|Primary|1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs)|"Number of participants with sustained virologic response (SVR): number of patients with undetectable HCV RNA 6 months off therapy by real-time PCR test (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, limit of detection < 25 IU/mL)~Number of participants who droppoed out of the study prematurely due to adverse events (AEs): number of patients who prematurely withdrew from the study due to any adverse events"|1.5 year|Outcome measures:intention-to-treat (ITT) analysis Imputation technique: last observation carried forward||Participants|||Number
137558|NCT00491075|Primary|Overall Response|Number of participants with complete or partial response. Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response: disappearance all target lesions; Partial Response: >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease: Insufficient shrinkage for partial response, or insufficient increase for progressive disease, reference smallest sum LD since treatment started.|Baseline to 8 weeks (after 4 cycles) protocol response at 16 weeks|One participant did not meet the required 16 week data end point and was excluded from the response evaluation and analysis.||percentage of participants||95% Confidence Interval|Number
137559|NCT00490971|Other Pre-specified|Clinical Global Impression - Bipolar Disorder - Severity of Illness (CGI-BP-S): Change From Baseline|The CGI-BP-S rating scale is used to rate the severity of bipolar disorder, including both depressed and manic components, on a 7-point scale ranging from 1 (not ill) to 7 (very severely ill). This scale permits a global evaluation of the subject’s bipolar condition at a given time. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Full Range|Median
137560|NCT00490971|Other Pre-specified|Global Assessment of Functioning (GAF): Change From Baseline|This scale is used when the clinical progress of a subject needs to be assessed in global terms, using a single measure. The GAF scale is rated with respect to psychological, social, and occupational functioning at the time of the assessment only. A higher score indicates a better functioning, with an overall range from 1 to 100. Positive Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Standard Deviation|Mean
137561|NCT00490971|Other Pre-specified|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS consists of 10 items covering all the important complaints which patient with depression have (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Item is scored from 0 (normal) to 6 (severe). Total score (0 to 60) is calculated by adding the scores of all 10 items. A higher score represents a more severe condition. Negative Change in Score Indicates Improvement.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Standard Deviation|Mean
137562|NCT00490971|Other Pre-specified|Young Mania Rating Scale (YMRS): Change From Baseline|This is method by which condition of patient suffering with mania is checked. In this scale patient's condition is assessed using 11 items. A severity rating is assigned to each of 11 items based on the how subject feels of his or her condition and the physicians observation of patients behavior. The range of the scale is 0 to 60. A higher score indicates a more severe condition. Change from baseline (Day 105) in the double‑blind maintenance phase to the last postbaseline assessment.|From 1st randomization into acute phase to end of acute/continuation phase (ie, up to 15 weeks after 1st randomization), or from randomization into maintenance (MA) phase to the end of MA phase (ie, up to 175 weeks (or 41 months) after 2nd randomization).|Intent-to-Treat||Scores on the scale||Standard Deviation|Mean
137563|NCT00490971|Secondary|Time to Recurrence of Depressive Symptoms Associated With Bipolar I Disorder|Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of depressive symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of depressive symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA period, which included participants who entered the maintenance phase and took at least 1 dose of study medication.||Days||95% Confidence Interval|Number
137564|NCT00490971|Secondary|Time to Recurrence of Manic Symptoms Associated With Bipolar I Disorder|This was the key secondary efficacy end-point. Pali/Pali and Pali/Placebo were compared with each other with respect to time to recurrence of manic symptoms. The criterias used for this analysis were similar to criterias used for primary analysis.|Date of randomization into the maintenance phase until the first occurrence of recurrence of manic symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set in MA phase, which included participants who entered the MA phase and took at least 1 dose of study medication.||Days||95% Confidence Interval|Number
137579|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 1 Medication|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 1 medication: 0.5%||percentage of participants|||Number
143191|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Occupational History and Socioeconomic Status"||Day 1 of a 1-day study|All participant respondents to the questions||participants|||Number
137565|NCT00490971|Primary|Time to Recurrence of Any Mood Symptoms (Manic or Depressive) Associated With Bipolar I Disorder|Time to first recurrence of any mood symptoms (ie, manic or depressive) associated with bipolar I disorder during the maintenance phase, after maintaining clinical stability during continued treatment with paliperidone ER over a period of 15 weeks. The time period was from occurrence of acute manic or mixed episode to Week 15. This outcome was measured using combination of various scales, hospitalization for any mood symptoms, use of any medicines for an mood episode and clinical events suggestive of recurrent mood episode associated with bipolar I disorder.|Date of randomization into the maintenance phase until the first occurrence of recurrence of any symptoms or discontinuation from the study, assessed over a period of 41 months.|Intent-to-treat analysis set (ITT) in maintenance (MA) phase, which included participants who entered the MA phase and took at least 1 dose of study medication.||Days||95% Confidence Interval|Number
137566|NCT00490945|Secondary|VEC-162 Tmax||Night 4|||hour||Standard Deviation|Mean
137567|NCT00490945|Secondary|VEC-162 Cmax||Night 4|||ng/mL||Standard Deviation|Mean
137568|NCT00490945|Secondary|VEC-162 AUC||Night 4|||ng*hr/mL||Standard Deviation|Mean
137569|NCT00490945|Secondary|Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)|"Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt.~Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2."|Night 2 and Night 4|*Placebo N = 7 and 100 mg VEC-162 N = 7||minutes||Standard Deviation|Mean
137570|NCT00490945|Primary|Mean Sleep Efficiency|Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.|Night 4 and Night 2|"*N = 6 for 3rd Third of Night Efficiency and N=8 for 1st Third of Night Efficiency~**N = 7 for 3rd Third of Night Efficiency"||% points||Standard Deviation|Mean
137571|NCT00490945|Primary|Circadian Phase Shift|Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.|Night 3 and Night 4|||Hours||Standard Deviation|Mean
137572|NCT00490919|Secondary|The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, 12 of double-blind phase|The full analysis population (FAP) (N = 541) consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. 2 subjects did not have safety data (N = 539).||Units on a scale||Standard Deviation|Mean
137573|NCT00490919|Secondary|The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase|Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.|weeks 2-12|Subjects in the full analysis population who took at least one dose of supplemental analgesic medication.||tablets||Standard Error|Mean
137574|NCT00490919|Primary|Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.|Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.|Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.|The full analysis population (FAP) (N = 541) [539] consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. (Two subjects did not have safety data.)||Units on a scale||Standard Deviation|Mean
137575|NCT00490841|Secondary|Renal Function (Measured by sCr)|"sCR= Serum Creatinine, per subject analysis. ITT. Renal function (measured by sCr) @ baseline: 1.2mg/dL (1.2, 1.3).~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.||mg/dL||95% Confidence Interval|Mean
137576|NCT00490841|Secondary|9 mo in Anti-hypertensive Medication In-take, ≥ 4 Medications|"Number of Anti-Hypertensive Medications taken at follow up compared to baseline, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to or greater than 4 Medications: 39.6%||percentage of participants|||Number
137577|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 3 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 3 Medications: 30.7%||percentage of participants|||Number
137578|NCT00490841|Secondary|9 Month Anti-hypertensive Medication In-take, 2 Medications|"Number of Anti-Hypertensive Medications taken-baseline compared to follow up, Per Subject Analysis (Intent-to-Treat Population)), reported as the percentage of participants using the number of medications indicated.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Patients with baseline Anti-Hypertensive medication intake equal to 2 medications: 29.2%||percentage of participants|||Number
137635|NCT00490477|Primary|Number of Participants Not Requiring Renal Replacement Therapy (RRT)||28 days from the admission|||participants|||Number
138286|NCT00485732|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres|Titres are given as geometric mean titres (GMTs) calculated on all subjects.|Before vaccination (PRE) and one month post Dose 3 (Month 7)|Analysis was performed on the ATP cohort for immunogenicity.||titre||95% Confidence Interval|Geometric Mean
137580|NCT00490841|Secondary|Secondary Patency Rate of <60% Stenosis of the Target Lesion|"As determined by duplex ultrasound or angiography regardless of PTA, stenting, or bypass since index procedure. Rate reported as a percentage of participants with this condition.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.||percentage of participants|Participants|95% Confidence Interval|Number
137581|NCT00490841|Secondary|Primary Patency|"Defined as <60% stenosis without prior re-intervention, as determined by duplex ultrasound or angiogram.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|9 months|Subject total reflects those who were evaluable at the time of analysis.||percentage of participants|Participants|95% Confidence Interval|Number
137582|NCT00490841|Secondary|Acute Clinical Success|"Procedure success without Major Adverse Events (MAE)or access site event requiring surgical or percutaneous intervention prior to hospital discharge.~The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician."|From beginning of index proceedure to end of index proceedure.|||percentage of participants||95% Confidence Interval|Number
137583|NCT00490841|Secondary|Acute Procedure Success|Attainment of a final result of < 30% residual stenosis, as determined by the Angiographic Core Lab.|From beginning of index proceedure to end of index proceedure.|||percentage of participants|Participants|95% Confidence Interval|Number
137584|NCT00490841|Secondary|Acute Device Success|Acute device success is defined as, on a per device basis, the achievement of successful delivery of the assigned device(s)as intended to the designated location.|From beginning of index procedure to end of index proceedure.|||percentage of devices|Participants|95% Confidence Interval|Number
137585|NCT00490841|Secondary|9 Month Blood Pressure (Diastolic)|As compared to baseline. See Population description.|9 months and baseline|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||mmHg||95% Confidence Interval|Mean
137586|NCT00490841|Secondary|9 Month Blood Pressure (Systolic)|As compared to baseline (pre-procedure). Blood pressure measurements at 9 months.|Baseline (Pre-Procedure) and 9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||mmHg||95% Confidence Interval|Mean
137587|NCT00490841|Secondary|Event Free Rate of Clinically Indicated Target Lesion Revascularization (TLR)|Event Free percentage: Defined as percentage of participants free from this event.|9 months|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||Event Free Percentage|||Number
137588|NCT00490841|Secondary|Embolic Events Resulting in Kidney Damage|Percentage of participants with an embolic event resulting in kidney damage.|30 days|The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||Percentage of participants||95% Confidence Interval|Number
137589|NCT00490841|Secondary|Ipsilateral Nephrectomy|Ipsilateral: Situated on or affecting the same side as treated. Nephrectomy: Removal of the affected kidney|30 days|intention to treat (ITT). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants||95% Confidence Interval|Number
137590|NCT00490841|Secondary|Death for Any Reason||30 days|Non-Hierarchical Subject Counts, Per Subject Analysis (Intent-to-Treat Population). The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants||95% Confidence Interval|Number
137591|NCT00490841|Primary|Binary Restenosis Rate|Determined by duplex ultrasound or angiogram. Reported as the percentage of participants with occurance of binary restenosis.|9 months|Subject total reflects those who were evaluable at the time of analysis. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.||Percentage of lesions|Participants|95% Confidence Interval|Number
137592|NCT00490815|Secondary|Retinal Thickness||over 36 months|||µg||Standard Deviation|Mean
137593|NCT00490815|Primary|Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor|This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.|over 36 months|||pg/ml||Standard Deviation|Mean
137594|NCT00490802|Secondary|Social Responsiveness Scale|The Social Responsiveness Scale has been developed to measure autism related symptoms and focuses more on social function than social cognition. The Social Responsiveness Scale has been modified for adults by and we have obtained permission to use the adult scale, although it is not commercially available yet. The Social Responsiveness Scale measures social behaviors such as social awareness, information processing, and social motivation and yields a quantitative score that has been useful in endophenotype studies of Autism Spectrum Disorder. The minimum score that can be obtained is a 0 and the maximum raw score for subscales is 66, maximum total raw score is 153. A lower score represents a positive response.|6 Weeks|||units on a scale||Standard Deviation|Mean
137595|NCT00490802|Secondary|Yale-Brown Obsessive-Compulsive Scale|The Yale-Brown Obsessive-Compulsive Scale is a clinician-rated questionnaire measuring the time spent, distress, interference, resistance, and control in relation to obsessions and compulsions based on a 5-point scale. This scale has excellent reliability and validity and is used as the gold standard to measure treatment challenges in all Obsessive-Compulsive Disorder clinical trials. The Yale-Brown Obsessive-Compulsive Scale Compulsion Subscale has been shown to be a reliable and valid scale in Autism Spectrum Disorder, and in measuring change in treatment studies of autism. The minimum score that can be obtained is 0 and the maximum score is 20. A lower score represents a positive response.|6 Weeks|||units on a scale||Standard Deviation|Mean
137636|NCT00490269|Primary|Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.|Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.|Day 9 and 10|||participants|||Number
137637|NCT00490256|Primary|iFAB Post-op|intestinal fatty acid binding protein level immediately postop|Immediate postop|||mcg/ml||Standard Deviation|Mean
137638|NCT00490256|Secondary|Cerebral and Lower Body Near Infra-red Spectroscopy Measures||24 hours||||||
137596|NCT00490802|Primary|Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test|The Diagnostic Analysis of Nonverbal Accuracy is a measure of emotion recognition across multiple modalities. It consists of five subtests: the Adult Facial Expression Test, the Child Facial Expression Test, the Adult Paralanguage Test, the Child Paralanguage Test, and the Adult Posture Test. The Diagnostic Analysis of Nonverbal Accuracy has established reliability and validity for children as young as 3 and adults as old as 100. The subtests of the test vary on four basic core emotions: happiness, sadness, anger, and fear, and the test provides measures of both high intensity and low intensity emotional reactions. We utilized both the Child Paralanguage and Adult Paralanguage Tests, therefore the minimum score that can be obtained is 0 and the maximum is 48. A higher score represents a positive response.|6 Weeks|||units on a scale||Standard Deviation|Mean
137597|NCT00490802|Primary|Repetitive Behavior Scale - Revised|"The Repetitive Behavior Scale - Revised was developed to capture the breadth of repetitive behaviors that are specific to autism and is a parent report measure. In particular, it consists of 43-items that tap six repetitive behavior subtypes: Stereotyped, Self-injurious, Compulsive, Ritualistic, Sameness, and Restricted Interests.~Two scores were calculated (higher-order vs. lower-order repetitive behaviors) in an effort to decrease the number of variables analyzed. This is based on previous factor analysis that produced these two factors: higher order (ritualistic, sameness, compulsive and restricted subscales) and lower order (stereotypy and self-injury).~The higher order behaviors have 29 items that can be endorsed with a maximum score of 87 and a minimum score of 0~The lower order behaviors have 14 items that can be endorsed, with a maximum score of 42 and a minimum score of 0~In both cases, a lower score represents a positive response."|6 Weeks|||units on a scale||Standard Deviation|Mean
137598|NCT00490802|Primary|Clinical Global Impressions Scale - Improvement - Social|"The Clinical Global Impressions Scale - Improvement - Social is a well validated measure employing a 7-point scale of clinical global impression of improvement ( 1- very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse) that the clinician fills out after considering all the available information on the participant including the parent history, the examination in clinic, reports from the school and other sources. Therefore the score is filtered through the judgment of the clinician evaluator.~The Week 6 Improvement Ratings were used to categorize patients as clinically improved (≤2) or not (>2). Sixteen of the 19 patients (84%) had data at Week 6. For the remaining three subjects, Week 6 ratings were imputed using expectation-maximization methods and the earlier Clinical Global Impression ratings. In all three cases the imputed ratings were >2 and the patients were classified as not improved."|6 Weeks|||participants|||Number
137599|NCT00490724|Secondary|Urinary Volume|The urinary volume was measured because nesiritide has a diuretic effect. Measurement of hour urine was done in the observation period and treatment period. 1-hour urine before treatment initiation was measured in the observation period. In the treatment period, 1-hour urine for period 1 and 3-hour urine for period 2 was measured. Urinary volume was recorded for participants without urethral catheterization having spontaneous micturition when needed.|Baseline, 3 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millliter||Standard Deviation|Mean
137600|NCT00490724|Secondary|Assessment of Dyspnea Using Respiratory Rate|Assessment of dyspnea was done by measuring respiratory rate which is the number of times an organism breathes with the lungs (respiration) per unit time, usually per minute|Baseline, 1, 2, 3, 6, 9, 15 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Breaths Per Minute (BrPM)||Standard Deviation|Mean
137601|NCT00490724|Secondary|Assessment of Dyspnea Using Percutaneous Arterial Oxygen Saturation (SpO2)|Assessment of dyspnea was done by measuring SpO2 via pulse oximetry, by making the participant lye quietly in the post anesthesia care unit (PACU) and breathing room air (RA)|Baseline, 1, 2, 3, 6, 9, 12, 15 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here,n=the participants evaluated for this measure at a particular time point.||Percentage of SpO2||Standard Deviation|Mean
137602|NCT00490724|Secondary|Number of Participants With Oxygen Therapy|Assessment of dyspnea was done by measuring number of participants showing presence or absence of oxygen therapy.|Baseline,1 and 24 hour|The PPS were the residual participants having a significant protocol deviation influencing the efficacy assessment, obtained by subtracting from the FAS population. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||Participants|||Number
137603|NCT00490724|Secondary|Number of Participants With Orthopnea|Assessment of dyspnea was done by measuring percentage of participants showing presence or absence of orthopnea (it is the sensation of breathlessness in the recumbent position, relieved by sitting or standing) symptoms|Baseline, 1 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.||Participants|||Number
137604|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Likert Scale Score|Assessment of Dyspnea was done using Likert scale. It is a 7-point scale where following scores stands for severity of dyspnea: 1=markedly better; 2=moderately better; 3=minimally better; 4=no change; 5=minimally worse; 6=moderately worse and 7= markedly worse|3, 6 and 24 hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.||Participants|||Number
137639|NCT00490256|Primary|Intestinal Fatty Acid Binding Protein and C-reactive Protein||Baseline and 0, 3, 12, and 24 hours after surgery||||||
137670|NCT00490035|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Seizure Frequency per Week||Inter-Quartile Range|Median
137605|NCT00490724|Secondary|Number of Participants With Dyspnea Symptoms Assessed by Borg Scale Score|Assessment of Dyspnea (difficult or labored breathing) was done using Borg scale. It is a 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all; 0.5=very very slight (just noticeable); 1=very slight; 2=slight; 3=moderate; 4=somewhat severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, 1 h and 24 h|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure.||Participants|||Number
137606|NCT00490724|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PVR (force that opposes the flow of blood through a vascular bed) was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. PVR was calculated by dividing (80*[MPAP−PCWP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||dyne*second/centimeter^5||Standard Deviation|Mean
137607|NCT00490724|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The SVR was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. SVR was calculated by dividing (80*[MBP−MRAP]) and CO.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||dyne*second per centimeter^5||Standard Deviation|Mean
137608|NCT00490724|Secondary|Change From Baseline in Stroke Volume Index (SVI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SVI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||milliliter per meter^2||Standard Deviation|Mean
137609|NCT00490724|Secondary|Change From Baseline in Stroke Volume (SV) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The SV was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. Stroke volume is the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. SV was calculated by dividing CO and heart rate (HR).|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||milliliter (ml)||Standard Deviation|Mean
137610|NCT00490724|Secondary|Change From Baseline in Cardiac Index (CI) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CI was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. CI was calculated by dividing CO and body surface area.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Liter per minute per meter^2 (l/min/m^2)||Standard Deviation|Mean
137611|NCT00490724|Secondary|Change From Baseline in Mean Blood Pressure (MBP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The MBP was a calculated hemodynamic parameter and the calculation was done on the basis of the measured hemodynamic parameters. MBP was calculated as sum of diastolic blood pressure (DBP) and (0.33*[SBP−DBP])|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
137612|NCT00490724|Secondary|Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The CO was a measured cardiopulmonary hemodynamic parameter. It is the volume of blood expelled by the ventricles of the heart with each beat. It was calculated as the product of stroke volume (output of either ventricle per heartbeat) and the number of beats per minute. Cardiac output is commonly measured by the thermodilution technique.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Liter per minute||Standard Deviation|Mean
137656|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137613|NCT00490724|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PCWP was a measured hemodynamic parameter. It was the blood pressure, recorded after wedging a catheter in a small pulmonary artery; believed to reflect the pressure in the pulmonary capillaries. It was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
137614|NCT00490724|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The MPAP was a measured hemodynamic parameter. MPAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
137615|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PADP was a measured hemodynamic parameter. Normal range of PADP is 8 to 15 millimeters of mercury (mmHg). PADP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
137616|NCT00490724|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PASP was a measured hemodynamic parameters. PASP was assessed by Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
137617|NCT00490724|Secondary|Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The MRAP was a measured hemodynamic parameter. MRAP was measured using a Swan-Ganz catheter.|Baseline, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour|The PPS included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations. Here, N=the participants evaluated for this measure and n=the participants evaluated for this measure at a particular time point.||Millimeters of mercury||Standard Deviation|Mean
137618|NCT00490724|Primary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours|Change in PCWP was unmeasurable, therefore it was complemented with PADP. PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline and 3 Hours|The per protocol set (PPS) included participants who met the eligibility criteria, received at least 1 dose of study medication and had one efficacy assessment after randomization except those who had significant protocol deviations.||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
137619|NCT00490698|Primary|Median Time to First Skeletal-related Event|Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.|Up to 1 year|Four participants did not experience skeletal events.||months||95% Confidence Interval|Median
137620|NCT00490646|Primary|Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|BOR was the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Refer to Outcome Measure 3 for definition of PD.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks).|All randomized participants.||participants|||Number
137621|NCT00490646|Secondary|Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.||participants|||Number
137668|NCT00490035|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Times per week||Inter-Quartile Range|Median
137709|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137622|NCT00490646|Secondary|Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0|Grade (GR)1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy. n=number of participants with measures available.||participants|||Number
137623|NCT00490646|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3=Severe; and Grade 4=Life-threatening or disabling. GR=Grade.|Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.)|Treated participants: Participants who received at least 1 dose of study therapy.||participants|||Number
137624|NCT00490646|Secondary|Duration of Response|"Period measured in months from time that measurement criteria were first met for CR or PR until first date of documented PD or death from any cause without prior documentation of progression.~PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall. Refer to Outcome Measure 1 for definitions of CR and PR. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by Brookmeyer and Crowley method."|From the date of first PR or CR assessment to the date of documented progressive disease or death without prior documentation of progression (maximum participant duration of response of 38 months.)|All randomized participants with CR or PR. The participants who neither relapsed nor died were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
137625|NCT00490646|Secondary|Time to Response|"Time to response was defined as the time in weeks from randomization until the measurement criteria are first met for a CR or PR, whichever is recorded first.~CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the LD of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization every 6 weeks for first 12 months and thereafter every 3 months until CR or PR whichever was recorded first (maximum participant time to response of 18.4 weeks.)|All randomized participants with CR or PR.||weeks||Full Range|Median
137626|NCT00490646|Secondary|Progression Free Survival (PFS)|"Time in months from randomization until first date of documented progressive disease (PD) or death from any cause without prior documentation of progression. PD=≥20% increase in sum of LD of target lesions in reference to smallest sum LD recorded at or following baseline or unequivocal progression of existing non-target lesion(s) overall.~Estimated by the Kaplan-Meier product limit method. A two-sided 95% CI for median duration was computed by the Brookmeyer and Crowley method."|From randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression (maximum participant PFS of 39.7 months).|All randomized participants. Participants who did not progress or died were censored on the date of their last tumor assessment.||months||95% Confidence Interval|Median
137627|NCT00490646|Primary|Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)|Percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A two-sided confidence interval (CI) was computed using the Clopper-Pearson method.|Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks)|All randomized participants.||percentage of participants||95% Confidence Interval|Number
137628|NCT00490555|Secondary|Dehydroepiandrosterone (DHEA)||10 weeks|||ng/mL||Inter-Quartile Range|Median
137629|NCT00490555|Secondary|Androstenedione (AED)||10 weeks|||ng/mL||Inter-Quartile Range|Median
137630|NCT00490555|Primary|Dihydrotestosterone (DHT) Concentration||10 weeks|||ng/mL||Inter-Quartile Range|Median
137631|NCT00490555|Primary|Testosterone Concentration||10 weeks|||ng/mL||Inter-Quartile Range|Median
137632|NCT00490555|Primary|Prostate-specific Antigen (PSA)|PSA level week 10 end of treatment|10 weeks|||ng/mL||Inter-Quartile Range|Median
137633|NCT00490542|Primary|The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups.|Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome.|Baseline to 6 weeks|Power analysis, with beta=0.20 and two-tailed alpha=0.05, was based on pilot studies for the mania registration trials which included mixed episodes and assessed MADRS scores. A projected standard error of the mean difference was assumed to be about twice as much as the mean difference (5-15 points), producing a sample size of about 100.||Scores on a scale||95% Confidence Interval|Mean
137634|NCT00490477|Secondary|The Reduction of the Number of Apoptotic Cells, Stimulated With Plasma Derives From Septic Patients With Gram Negative Infection, Treated With PMX-B Hemoperfusion, on Immortalized Tubular and Glomerular Cell Cultures.||72 hours after randomization||04/2007||||
137640|NCT00490139|Secondary|DFS Ignoring Non-breast Second Primary Malignancies|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer, or death from any cause. DFS was estimated using the Kaplan Meier method. The non-breast second primary malignancies were not considered events.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who did not have DFS ignoring non-breast second primary malignancies for the indicated years. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease, or did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact. Non-breast second primary cancers were ignored.||years|||Number
137641|NCT00490139|Secondary|Time to Central Nervous System Recurrence|Time to central nervous system recurrence is defined as the time from randomization until the first central nervous system recurrence. Both brain metastasis and meningitis carcinomatosa were considered.The percentile data values presented here indicate that 95 percent of participants did not have central nervous system recurrence for the indicated years.|From randomization until the first central nervous system recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a central nervous system recurrence were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.||years|||Number
137642|NCT00490139|Secondary|Time to Distant Recurrence|Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of distant recurrence (including central nervous system recurrence). The percentile data values presented here indicate the percentage (95, 90, 85 and 80 percent) of participants who did not have distant recurrence for the indicated years.|From randomization until the date of the first occurrence of distant recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a distant recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility.||years|||Number
137643|NCT00490139|Secondary|Time to Recurrence|Time to recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a disease recurrence (local, regional or distant). The percentile data values presented here indicate the percentage (95, 90, 85, and 80 percent) of participants who did not have disease recurrence for the indicated years. IDMC=Independent Data Monitoring Committee.|From randomization until the date of the first occurrence of a disease recurrence (median follow-up of 4.5 years)|ITT Population. Participants who did not have a recurrence of the initial disease were censored at the date of the last recorded physical or radiological examination. Death was treated as a competing risk. Zero participants were analyzed in the lapatinib arm, as the IDMC discontinued the lapatinib-alone arm due to futility at the interim analysis.||years|||Number
137644|NCT00490139|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause. Overall survival was calculated in years as (date of death minus the date of randomization +1) divided by 365.25. The percentile data values presented here indicate the percentage (99, 98, 97, 96, 95 and 90 percent) of participants who survived for the indicated years.|From randomization until death due to any cause (median follow-up of 4.5 years)|ITT Population. Participants who did not die were censored at the date of last survival contact. Zero participants were analyzed in the lapatinib arm, as the Independent Data Monitoring Committee discontinued the lapatinib-alone arm due to futility at the time of the first interim analysis (lapatinib participants were then offered trastuzumab).||years|||Number
137645|NCT00490139|Primary|Disease-free Survival (DFS)|Disease-free survival is defined as the interval between randomization and the date of the first occurence of disease recurrence (local, regional or distant), a contralateral invasive breast cancer, a second primary cancer (SPC), or death from any cause. DFS was estimated using the Kaplan Meier method.The percentile data values presented here indicate the percentage (95, 90, 85, 80 and 75 percent) of participants who had disease free survival for the indicated years.|From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years)|Intent-to-Treat (ITT) Population: all randomized par., except for those who withdrew their consent to use any of their data prior to receiving any study medication. Par. with no recurrence of the initial disease or SPC, or who did not die, were lost to follow-up, or were withdrawn from the study were censored at the date of last clinical contact.||years|||Number
137646|NCT00490100|Primary|Change in Growth Rate on Study Drug|Growth rate on intervention is compared with growth rate before intervention for each participant.|During intervention, up to 2 years|Only participants who completed study||cm/year||Full Range|Median
137647|NCT00490100|Primary|Safety of Study Drug|Rates of adverse events related to study drug|1 year|||participants|||Number
137648|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
140500|NCT00465101|Other Pre-specified|Length of Catheterization (LOC)|Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).|Recovery Period|Participants who received the study treatment and for whom the outcome measure is available.||hours||Standard Deviation|Mean
137649|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137650|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137651|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137652|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137653|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137654|NCT00490035|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement), with the start of the study medication as reference time point. The Investigator was to complete it by answering the following question: “Assess the Overall change in the severity of patient’s illness, compared to start of study medication.”|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137655|NCT00490035|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject not mentally impaired had to complete it by answering the following question: “Overall, has there been a change in your seizures since the start of the study medication?”|Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.||units on a scale||Standard Deviation|Mean
137669|NCT00490035|Secondary|Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period|"Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week.~The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a >= 50 % reduction in seizure frequency per week from Baseline."|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percentage of Participants|||Number
137657|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.|From Baseline to 12-week Treatment Period|Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
137658|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intenion-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
137659|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
137660|NCT00490035|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.||units on a scale||Standard Deviation|Mean
137661|NCT00490035|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.|"Reduction of Type IC/Type I Seizure frequency ratio from Baseline to the 12- week Treatment Period.~This variable was not analyzed and no results are available."|From Baseline to 12-week Treatment Period||||||
137662|NCT00490035|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
137663|NCT00490035|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
137664|NCT00490035|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Type I Seizure during the 12-week Treatment Period was measured in days.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
137665|NCT00490035|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percentage of Participants|||Number
137666|NCT00490035|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"The categories are:~<= 25 %~- 25 % to < 25 %~25 % to < 50 %~50 % to < 75 %~75 % to < 100 %~100 %"|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percentage of Participants|||Number
137667|NCT00490035|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) * 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.|From Baseline to 12-week Treatment Period|The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.||Percent change in seizures per week||Inter-Quartile Range|Median
137710|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137671|NCT00490022|Secondary|Prostate Epithelial Cell Proliferation|Prostate epithelial cell proliferation in the prostate biopsy tissue was measured using Ki-67 immunohistochemical staining of prostate epithelium as a marker of cell proliferation (values are number of Ki-67 positive stained cells per 100 prostate epithelial cells). The placebo and treatment groups were compared.|28-days|||#pos.Ki-67cells per100 prst. epth cells||Standard Deviation|Mean
137672|NCT00490022|Primary|Prostate Tissue DHT and Testosterone Levels After 28 Days of Treatment With Dihydrotestosterone [DHT] Gel Versus Placebo Gel.|After 4 weeks of either daily dihydrotestosterone transdermal gel or placebo gel, subjects underwent a prostate biopsy. Intraprostatic hormone concentrations, specifically DHT and Testosterone, were measured. Unit of measure is ng/g.|28-days|||ng/g||Standard Deviation|Mean
137673|NCT00489970|Secondary|Anti-PRN Antibody Concentration||9 years following vaccination||06/2016||||
137674|NCT00489970|Secondary|Anti-FHA Antibody Concentration||9 years following vaccination||06/2016||||
137675|NCT00489970|Secondary|Anti-PT Antibody Concentration||9 years following vaccination||06/2016||||
137676|NCT00489970|Secondary|Anti-T Antibody Concentration||9 years following vaccination||06/2016||||
137677|NCT00489970|Secondary|Anti-D Antibody Concentration||9 years following vaccination||06/2016||||
137678|NCT00489970|Secondary|Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
137679|NCT00489970|Secondary|Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
137680|NCT00489970|Secondary|Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
137681|NCT00489970|Secondary|Anti-PRN Antibody Concentration|Anti-PRN antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||EL.U/mL||95% Confidence Interval|Geometric Mean
137682|NCT00489970|Secondary|Anti-FHA Antibody Concentration|Anti-FHA antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||EL.U/mL||95% Confidence Interval|Geometric Mean
137683|NCT00489970|Secondary|Anti-PT Antibody Concentration|Anti-PT antibody concentration is expressed as GMC in EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||EL.U/mL||95% Confidence Interval|Geometric Mean
137684|NCT00489970|Secondary|Anti-T Antibody Concentration|Anti-T antibody concentration is expressed as GMC in IU/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||IU/mL||95% Confidence Interval|Geometric Mean
137685|NCT00489970|Secondary|Anti-D Antibody Concentration|Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||IU/mL||95% Confidence Interval|Geometric Mean
137686|NCT00489970|Secondary|Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||subjects|||Number
137687|NCT00489970|Secondary|Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.||subjects|||Number
137688|NCT00489970|Secondary|Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|The cut-off for anti-PT concentrations was defined as equal to or greater than 5 ELISA units per mililiter (EL.U/mL).|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||subjects|||Number
137689|NCT00489970|Primary|Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|Anti-D cut-off was defined as greater than or equal to 0.1 international units per mililiter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA) or VERO.|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint.||subjects|||Number
137690|NCT00489970|Primary|Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
143192|NCT00442468|Secondary|"Number of Participants Who Responded Yes to Respective Questions Regarding Past Illness"||Day 1 of a 1-day study|All participant respondents to the questions||participants|||Number
137691|NCT00489970|Primary|Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off|Anti-T cut-off was defined as greater than or equal to 0.1 IU/mL (ELISA).|1, 3 and 5 years following vaccination|Analysis was performed on the According-to-Protocol (ATP) Year 1, 3 or 5 Cohort, which included all subjects who were in the ATP cohort for analysis of immunogenicity in the primary study (NCT00346073) and for whom serological results for at least one antigen were available for the specified timepoint||subjects|||Number
137692|NCT00489970|Primary|Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off||9 years following vaccination||06/2016||||
137693|NCT00489866|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression. Scores range from 0 to 63 (higher scores suggest higher levels of depression). Change scores were calculated from Week 2 and Week 6 scores (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.||Units on a Scale||Standard Deviation|Mean
137694|NCT00489866|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience. Change scores calculated at Week 2 and Week 6 (Week 2 minus Week 6).|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.||Units on a scale||Standard Deviation|Mean
137695|NCT00489866|Primary|Positive and Negative Symptoms Scale (PANSS)|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)|Week 2 and Week 6|Analysis was Intention to Treat. Last Observation Carried Forward was the imputation technique utilized.||Units on a Scale||Standard Deviation|Mean
137696|NCT00489866|Primary|Brief Assessment of Cognition in Affective Disorders (BAC-A)|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).|Week 2 and Week 6|||Units on a Scale||Standard Deviation|Mean
137697|NCT00489866|Primary|Clinician Administered PTSD Scale (CAPS)|"Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).~A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms."|Week 2 and Week 6|Analysis was intention to treat.||Units on a scale||Standard Deviation|Mean
137698|NCT00489853|Secondary|SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score|Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.|Single measurement taken at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
137699|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Kilopascals||Standard Deviation|Mean
137700|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137701|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137702|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137703|NCT00489853|Secondary|Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137704|NCT00489853|Secondary|Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137705|NCT00489853|Secondary|Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||kilopascal||Standard Deviation|Mean
137706|NCT00489853|Secondary|Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liter||Standard Deviation|Mean
137707|NCT00489853|Secondary|Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Mean
137708|NCT00489853|Secondary|Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)|Treatment means from individual participant data.|Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Liters||Standard Deviation|Median
137713|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). All patients with data are included.|Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
137714|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
137715|NCT00489853|Secondary|Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).|Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
137716|NCT00489853|Secondary|Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose|The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness. Patients are allowed to assign an even higher number depending on their perceived level of breathlessness).|Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
137717|NCT00489853|Secondary|Number of Inhalations of Reliever Medication|The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Number of inhalations during 24 hours||Standard Deviation|Mean
137718|NCT00489853|Secondary|Cough Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Scores on a scale||Standard Deviation|Mean
137719|NCT00489853|Secondary|Chest Tightness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Score on a scale||Standard Deviation|Mean
137720|NCT00489853|Secondary|Breathlessness Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing). All patients with data from both periods are included.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Score on Scale||Standard Deviation|Mean
137721|NCT00489853|Secondary|Sleep Score|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms).|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Score on Scale||Standard Deviation|Mean
137722|NCT00489853|Secondary|Peak Expiratory Flow (PEF) Before Morning Dose|The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.|Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period|||Liters/minute||Standard Deviation|Mean
137723|NCT00489853|Secondary|Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment|||Liters||Standard Deviation|Mean
137724|NCT00489853|Secondary|Forced Vital Capacity (FVC) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment|||Liters||Standard Deviation|Mean
137725|NCT00489853|Secondary|Forced Expiratory Flow (FEV1) Pre-dose|The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.|Pre-dose at the start of treatment and pre-dose after one week of treatment|||Liters||Standard Deviation|Mean
137726|NCT00489853|Secondary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken 6 hours post-dose at the end of each 1-week treatment period|||Seconds||Standard Deviation|Mean
137727|NCT00489853|Primary|Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose|Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.|Single measurement taken1 hour post-dose at the end of each 1-week treatment period|||Seconds||Standard Deviation|Mean
137728|NCT00489736|Other Pre-specified|Occurrence of the MSE Excluding Gastrointestinal Specific Treatment Emergent Events Defined as Diarrhoea, Nausea, Vomiting|"The considered event is the occurrence of the MSE excluding gastrointestinal specific treatment emergent events defined as diarrhoea, nausea, vomiting. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.||participants|||Number
138085|NCT00487240|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint||baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||hypoglycemic events per 30 days||Standard Deviation|Mean
137729|NCT00489736|Secondary|Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event|"The considered event is the occurrence of the MSE defined as thyroid, hepatic, pulmonary, neurological, skin, eye, or gastrointestinal specific treatment emergent events or premature study drug discontinuation following any adverse event (AE), whichever comes first. The analysis is performed on the time from first study drug intake to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the safety analysis according to the treatment received.||participants|||Number
137730|NCT00489736|Primary|Treatment Failure|"The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period."|minimum study duration is 6 months (+10 days); maximum is 15 months|All randomized and treated patients (receiving at least one dose of study drug) were included in the efficacy analysis according to the treatment received.||participants|||Number
137731|NCT00489554|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 5|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
137732|NCT00489554|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
137733|NCT00489554|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 fever was axillary temperature > 39.5°C. Grade 3 drowsiness, irritability, and loss of appetite was general symptom which prevented normal everyday activities. Grade 3 diarrhea was ≥ 6 looser than normal stools/day and Grade 3 vomiting was ≥ 3 episodes of vomiting/day. Related was solicited general symptom considered by the investigator to have a causal relationship to study vaccination.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
137734|NCT00489554|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of grade and whatever the number of injections.|Within 4 days following any vaccine dose|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.||subjects|||Number
137735|NCT00489554|Secondary|Number of Subjects Seropositive for Anti-Protein D Antibodies|Seropositivity was defined as antibody concentration greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
137736|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody opsonic titer greater than or equal to 8. The vaccine pneumococcal cross-reactive serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
137737|NCT00489554|Secondary|Number of Subjects Seropositive Against Cross-reactive Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
137738|NCT00489554|Secondary|Number of Subjects Seropositive for Opsonic Titer Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as an opsonic titer greater than or equal to 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
137739|NCT00489554|Secondary|Number of Subjects Seropositive Against Vaccine Pneumococcal Serotypes|Seropositivity was defined as anti-pneumococcal antibody concentration greater than or equal to 0.05 microgram per milliliter. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
137740|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Cross-reactive Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
138152|NCT00486954|Secondary|Cmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population||ng/mL||95% Confidence Interval|Geometric Mean
137741|NCT00489554|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes|Antibody concentrations were expressed as Geometric Mean Concentrations against pneumococcal cross-reactive serotypes 6A and 19A.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||microgram per milliliter||95% Confidence Interval|Geometric Mean
137742|NCT00489554|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotypes Antibody Concentrations Greater Than or Equal to 0.2 Microgram Per Milliliter|The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||subjects|||Number
137743|NCT00489554|Secondary|Opsonophagocytic Titer Against Pneumococcal Vaccine Serotypes|The results were presented as the geometric mean dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
137744|NCT00489554|Primary|Antibody Concentrations Against Protein D|Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||ELISA units per milliliter||95% Confidence Interval|Geometric Mean
137745|NCT00489554|Primary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes|Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|One month after the administration of the 3rd vaccine dose i.e. Month 5|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available.||microgram per milliliter||95% Confidence Interval|Geometric Mean
137746|NCT00489541|Secondary|Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the patients who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|Intent-to-Treat. All enrolled patients are included in the analysis.||participants|||Number
137747|NCT00489541|Primary|In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA)|Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.|9 months post-index procedure|The primary analysis population for the superiority testing of the primary endpoint, 9-month in-stent late loss, is the intent-to-treat (ITT) population, i.e. all patients who had a study device implanted at the target lesion and completed their angiographic follow-up.||millimeter||Standard Deviation|Mean
137748|NCT00489489|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
137749|NCT00489489|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-β dose level as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||relapses per year||95% Confidence Interval|Number
137750|NCT00489489|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN;"|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
137751|NCT00489489|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters per scan|||Number
137752|NCT00489489|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||lesions per scan||95% Confidence Interval|Number
137753|NCT00489489|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume of all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters||Standard Error|Least Squares Mean
137754|NCT00489489|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly Hair loss and Hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
137755|NCT00489489|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
137756|NCT00489424|Secondary|Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity|Effect on severity of symptoms following i.v. infusion of zoledronic acid 5 mg. The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms). The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion.|0 - 3 days|Intent to Treat (ITT) population. Number of participants analyzed may vary from ITT population due to some patients not reporting baseline or post baseline VAS measurement. Calculating change requires both baseline and post baseline values to be present.||units on a scale||Standard Deviation|Mean
137757|NCT00489424|Secondary|Proportion of Patients Reporting Severe Questionnaire Symptoms.|A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline.|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
137758|NCT00489424|Secondary|Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.|A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v. infusion of zoledronic acid 5 mg. The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
137759|NCT00489424|Secondary|Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. Two patients who took rescue medication in fluvastatin arm were not included in analysis since the time rescue medication was taken was not recorded.||hours||Standard Deviation|Mean
137760|NCT00489424|Secondary|Number of Rescue Medication Tablets Taken|Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Number of patients who took rescue medication at least once. One patient in acetaminophen arm was not included in analysis since the number of tablets taken was not recorded.||tablets||Standard Deviation|Mean
137761|NCT00489424|Secondary|Proportion of Patients Who Used Rescue Medication.|Patients that took rescue medication >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.|0 - 3 days|Intent to Treat (ITT) population. One patient who used rescue medication in acetaminophen arm and two patients in fluvastatin arm were not included in analysis due to lack of documentation regarding use and exposure of rescue medication.||proportion of patients|||Number
137762|NCT00489424|Secondary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.|Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
137763|NCT00489424|Primary|Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.|Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.|0 - 3 days|Intent to Treat (ITT) population.||proportion of patients|||Number
137785|NCT00489255|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137764|NCT00489359|Secondary|Phase 2 - Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
137765|NCT00489359|Secondary|Phase 2 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline through end of Phase 2 (up to 31 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||participants|||Number
137766|NCT00489359|Secondary|Phase 2 - Overall Survival|Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. This analysis was not done due to the high number of censored patients.|baseline to date of death from any cause (up to 31 months)|Protocol Qualified (PQ) population. This analysis was not done due to the high number of censored patients.||months||95% Confidence Interval|Median
137767|NCT00489359|Secondary|Phase 2 - Time to Treatment Failure|Time to treatment failure (TTTF) is defined as the time from the date of study enrollment to the date of the first observation of disease progression, death from any cause, or early discontinuation of treatment (any reason). For patients who are alive, progression-free, and have not discontinued early at the time of analysis, TTTF will be censored at the date of the last objective progression-free disease assessment.|First treatment to discontinuation of study drug, progressive disease, or death (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
137768|NCT00489359|Secondary|Phase 2 - Time to Disease Progression|Time to objective progressive disease (TTPD) is defined as the time from the date of study enrollment to the date of objectively determined Progressive Disease (PD). For patients who die without objective PD (including death from study disease), TTPD will be censored at the date of the last objective progression-free disease assessment. For patients who are still alive at the time of analysis, and who do not have PD, TTPD will be censored at the date of the last objective progression-free disease assessment.|baseline to measured progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined using RECIST."||Months||95% Confidence Interval|Median
137769|NCT00489359|Secondary|Phase 2 - Duration of Response (DOR)|Duration of response is defined as the time from first observation of Complete Response or Partial Response to the first observation of Progressive Disease or death from any cause. For patients who are still alive at the time of analysis, and who do not have Progressive Disease, duration of response will be censored at the date of the last objective progression-free disease assessment.|time of response to progressive disease (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
137770|NCT00489359|Secondary|Phase 2 - Time to Response (TTR)|Response is defined as CR (Complete Response) or PR (Partial Response) per RECIST criteria. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|First treatment to response (up to 31 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||Months||95% Confidence Interval|Median
137771|NCT00489359|Secondary|Phase 1 - Number of Participants With Tumor Response|Patients were analyzed by Cancer Antigen-125 (CA-125) response criteria and RECIST guidelines. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||Participants|||Number
137772|NCT00489359|Secondary|Phase 1 - Recommended Area Under the Curve (AUC) Dose of Carboplatin for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD determined by increasing doses up to AUC 6 mg/mL*min based on pattern of DLT (Outcome #3). If none of 3 initial participants at given level had DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had DLT in Cycle 1 at dose level, that dose level was considered MTD. However, based on results from Phase 2 Study (NCT00109096), further dose escalations were not explored: carboplatin dose was selected based on standard dose employed in control arm of first-line therapy for epithelial ovarian cancer (Bookman 2006).|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||mg/mL*min|||Number
137802|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 1||Days 1-28|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
137773|NCT00489359|Secondary|Phase 1 - Recommended Dose of Pemetrexed for Phase 2|MTD was to be used as Phase 2 recommended dose. MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 based on observed pattern of dose limiting toxicity (DLT: See Outcome #3). If none of 3 initial participants at a given level had a DLT in Cycle 1, enrollment proceeded to next dose level. If at least 2 participants had a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from another Phase 2 Study (NCT00109096), further dose escalations were not explored and dose was selected based on results of that Phase 2 Study.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||mg/m^2 (milligrams per square meter)|||Number
137774|NCT00489359|Secondary|Phase 1 - Number of Participants With Adverse Events (Toxicity)|A listing of adverse events is located in the Reported Adverse Event module.|baseline measured to progressive disease (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||Participants|||Number
137775|NCT00489359|Secondary|Phase 1 - Number of Dose-Limiting Toxicities (DLTs)|"The following toxicities were considered DLT: CTCAE Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 × 10^9/L lasting ≥7 days. Febrile neutropenia (ANC <1.0 × 10^9/L, fever 38.5°C, and no documented infection). CTCAE Grade 4 thrombocytopenia (platelets <25.0 × 10^9/L).~Any hemorrhage with CTCAE Grade ≥3 thrombocytopenia (50.0 × 10^9/L). CTCAE Grade ≥3 nonhematologic toxicity (excluding nausea, vomiting, or CTCAE Grade 3 alanine transaminase (ALT) or aspartate aminotransferase (AST) that returned to baseline prior to next treatment).~Treatment delay more than 1 week due to toxicity."|baseline through end of Phase 1 (up to 18 months)|Intention to Treat (ITT) population - all patients that consented and were successfully screened (note patient may or may not have received treatment; patients that were screen failures were not included in this population).||DLT events|||Number
137776|NCT00489359|Primary|Phase 2 - Percentage of Participants With Overall Tumor Response (Response Rate)|"Response is defined as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions.~Response rate (%) = (number of patients with CR+PR/number of patients in Phase 2)*100"|baseline to measured progressive disease (PD) (up to 18 months)|"Protocol Qualified (PQ) population. This population includes all patients in the Phase 2 study who met the following requirements:~Histologic diagnosis of ovarian or primary peritoneal cancer, no concurrent chemotherapy, treatment with at least 1 dose of pemetrexed or 1 dose of carboplatin, presence of measurable disease as defined by RECIST."||percentage of participants||95% Confidence Interval|Number
137777|NCT00489359|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Carboplatin|MTD was to be determined by increasing doses of pemetrexed up to 900 mg/m^2 and carboplatin Area Under the Concentration-Time Curve (AUC) up to 6 mg/mL*min based on observed pattern of dose limiting toxicity (DLT). See Outcome #3 for DLT. If none of 3 initial participants at a given level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level. If at least 2 participants experienced a DLT in Cycle 1 at a dose level, that dose level was considered the MTD. However, based on results from a different Phase 2 Study (NCT00109096), further dose escalations were not explored.|First treatment to toxicity (up to 18 months)|MTD was not determined in this study, so zero participants were analyzed.||mg/m^2|||Number
137778|NCT00489268|Secondary|Sub-squamous Intestinal Metaplasia|The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.|5 year|The analysis was done per protocol.||Percent of Participants with Sub-squamou|||Number
137779|NCT00489268|Secondary|Adverse Events|The secondary outcome adverse events was defined as any event that occurred during the course of the trial|5 year|The analysis was done per protocol.||Participants|||Number
137780|NCT00489268|Secondary|Progression of Histological Grade|Secondary outcomes of progression of histological grade was defined as proportion of participants who had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis.|5 year|The analysis was done per protocol.||Percent of Participants|||Number
137781|NCT00489268|Primary|Histological Clearance of Barrett's Metaplasia (Percent Patients)|The primary study outcomes were defined as the percent of patients with complete histological response to intestinal metaplasia (IM) (CR-IM).|5 year|The analysis was done per protocol.||Percent of Participants|||Number
137782|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137783|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137784|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137803|NCT00489255|Primary|Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1||Day 1 (Period 1, Visit 2)|Primary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
137804|NCT00489086|Secondary|Overall Response at Treated Lesions||36 months||||||
137786|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137787|NCT00489255|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137788|NCT00489255|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1|Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137789|NCT00489255|Secondary|Median Time to 'on' for Visit 5/End of Period 3 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 84 (Visit 5)|||minutes||95% Confidence Interval|Median
137790|NCT00489255|Secondary|Median Time to 'on' for Visit 4/End of Period 2 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 56 (Visit 4)|||minutes||95% Confidence Interval|Median
137791|NCT00489255|Secondary|Median Time to 'on' for Visit 3/End of Period 1 Injection|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||minutes||95% Confidence Interval|Median
137792|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 2|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||minutes||95% Confidence Interval|Median
137793|NCT00489255|Secondary|Median Time to 'on' for Visit 2/Period 1 Injection 1|Time to “on” (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of “on” and time of injection.|Day 1 (Visit 2)|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||minutes||95% Confidence Interval|Median
137794|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 3|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 84 (Visit 5)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.||participants|||Number
137795|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 2|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 56 (Visit 4)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.||participants|||Number
137796|NCT00489255|Secondary|Subject Global Evaluation of Randomized Study Medication for Period 1|The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question “Overall, how would you rate the study medication you received for nausea/vomiting?” Response choices were excellent, very good, good, fair, or poor.|Day 28 (Visit 3)|This secondary efficacy analysis was performed on the total number of subjects who responded to the evaluation within the Intention-to-Treat (ITT) population.||participants|||Number
137797|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137798|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137799|NCT00489255|Secondary|Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1|The INVR is an 8-item, 5 point Likert-type measurement of the patient’s perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.|Days 1-28|This secondary efficacy analysis was performed on the Intention-to-Treat (ITT) population.||score on a scale||Standard Deviation|Mean
137800|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 3||Days 57-84|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
137801|NCT00489255|Secondary|Incidence of Nausea and/or Vomiting for Period 2||Days 29-56|Secondary efficacy analyses performed on the Intention-to-Treat (ITT) population.||participants|||Number
137808|NCT00489086|Primary|Complete Response Rate|The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient’s “target” lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.|36 months|Intention to treat||participants|||Number
137809|NCT00488865|Primary|Percentage of Participants With Retrieval Clinical Success|Intact filter retrieval via percutaneous techniques from the vasculature without associated injury or damage to the vena cava requiring intervention.|upto 175 days|The population for Option filter retrieval was based on intention to treat (ITT). Retrieval procedures were attempted in 39 of the 100 enrolled patients.||Percent of Participants||95% Confidence Interval|Number
137810|NCT00488865|Secondary|Placement Technical Success|Successful deployment of the filter at the intended placement level such that the filter is judged suitable by the Investigator for mechanical protection against pulmonary embolism.|Immediately post placement procedure|||Percent of Participants||95% Confidence Interval|Number
137811|NCT00488865|Primary|Percentage of Participants With Clinical Success|Placement Technical Success without subsequent pulmonary embolism, significant filter migration, symptomatic caval thrombosis or other complication requiring filter removal or invasive intervention to address condition.|up to 180 days|The number of participants was determined per intention to treat (ITT).||Percent of Participants||95% Confidence Interval|Number
137812|NCT00488826|Secondary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"The population analyzed was all the available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post third dose serum available for assessment) and were in either 7vPnC+DTaP Concurrently or DTaP Alone group. The 7vPnC Separately group was not included as part of this objective."||ug/ml||95% Confidence Interval|Geometric Mean
137813|NCT00488826|Primary|Concentration of Serotype-Specific IgG Antibodies|Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study, and as 0.35 ug/ml by the World Health Organization (WHO).|7 months|"Population analyzed was available immunogenicity population (all subjects who completed the primary series of 7vPnC or DTaP and had the post-third dose serum available for assessment) and were in either the 7vPnC separately or DTaP alone group. The 7vPnC + DTaP group was not part of the primary objective; no statistical testing was done."||ug/ml||95% Confidence Interval|Geometric Mean
137814|NCT00488774|Secondary|Number of Participants With Clinical Remission|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.||Participants|||Number
137815|NCT00488774|Primary|Number of Participants With Clinical Response|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here ‘N’ signifies participants who were evaluated for this outcome measure.||Participants|||Number
137816|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific IgG concentrations, the geometric mean concentration was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.||µg/mL||95% Confidence Interval|Geometric Mean
137817|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Serogroup A, C, W-135 and Y specific IgG concentrations were measured before and one month after MenACWY-CRM booster vaccination by ELISA.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.||µg/mL||95% Confidence Interval|Mean
137818|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccination at 12 months of age.|7 days post 12 months vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).||Percentage of subjects|||Number
138795|NCT00480493|Primary|Maternal Confidence Scale|Maternal confidence in managing child with type 1 diabetes . Higher total scores (10 questions, minimum score of 0, maximum score of 50) mean a better outcome (greater maternal confidence)|12 months|All participants with data were analyzed||units on a scale||Standard Deviation|Mean
137819|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccinations at 12 months of age.|7 days post 12 month vaccination|The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age).||Percentage of subjects|||Number
137820|NCT00488683|Secondary|Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations|Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM (2 and 4 months) and routine infant primary vaccinations (2, 3 and 4 months).|7 days post vaccination at 2, 3, and 4 months of age|The analysis was performed on the safety population.||Percentage of subjects|||Number
137821|NCT00488683|Secondary|Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.|Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after each MenACWY-CRM and routine infant vaccination administered as a primary course of vaccination.|7 days post each MenACWY-CRM and routine infant vaccination|The analysis was performed on the Safety Population.||Percentage of subjects|||Number
137822|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months|"The rise in serogroup-specific hSBA and IgG was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x) at 12 months where x is the serogroup specific IgG or SBA titers.~Linear regression analysis between memory B cells at 5 months of age and rise in hSBA titers or IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model."|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset after booster vaccination.|||||Number
137823|NCT00488683|Secondary|Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM|Linear regression analysis between memory B cells at 5 months of age and hSBA titers and IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model.|1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)|Analysis was performed on the PP dataset of persistence population.|||||Number
137824|NCT00488683|Secondary|Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants|The serogroup A, C, W-135 and Y specific IgG concentrations were measured in the serum of mothers at the time of their enrollment into the study (Day 1) by ELISA.|Day 1 (IgG) and one month after primary vaccination (B cells)|Analysis was performed on the PP primary population.|||||Number
137825|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination|To assess the kinetics of serogroup A, C, W-135 and Y specific hSBA titers, the geometric mean titer was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.|Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.||titers||95% Confidence Interval|Geometric Mean
137826|NCT00488683|Secondary|Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination|"To assess the kinetics of serogroup A, C, W-135 and Y specific memory B cells, plasma B cells and IgG concentrations were measured on days 0, 7, 14, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study.~The memory B cell response at different timepoint was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators in vitro.~The B plasma cell response at each time point was defined as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC."|Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4|This outcome was assessed in Group 1 PP set population.||per 2x100000 cells||Standard Deviation|Mean
137827|NCT00488683|Secondary|Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination|The memory B cell response in children lacking a hSBA titer ≥1:8 one month after MenACWY-CRM primary vaccination was calculated as the mean number of meningococcal serogroup specific memory B cells, measured by ELISpot assay per 2x100000 LOC.|One month after primary vaccination|Analysis was performed on the PP primary population and PP persistence population, subjects lacking hSBA ≥1:8 one month after primary vaccination.||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
137828|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|hSBA GMTs were measured before and one month after MenACWY-CRM booster vaccination at 12 months of age.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.||titers||95% Confidence Interval|Mean
137829|NCT00488683|Secondary|Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone|Memory B cell response before and one month after MenACWY-CRM booster vaccination at 12 months of age was measured as mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells by ELISpot assay per 2x100000 LOC.|Before and one month after booster vaccination|Analysis was performed on the PP dataset of booster vaccination.||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
145079|NCT00427635|Secondary|Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
137830|NCT00488683|Secondary|CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination|"CRM197 specific memory B cell response at each time point was measured as mean number of CRM197 specific memory B cells by ELISpot assay per 2x100000 LOC.~CRM197 specific IgG concentration was measured by ELISA at 12 months of age and one month after MenACWY-CRM booster vaccination."|5 months (B cells), 12 months and 13 months (B cells and IgG) of age|Analysis was done on the PP primary population and PP booster population.|||||Number
137831|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and at 1 week after third vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~Plasma B cell response at 1 week after vaccination was measured as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC.~Serogroup A, C, W-135 and Y specific IgG were measured by ELISA and hSBA GMTs were measured at 1 week after third vaccination."|One month after primary vaccination and 1 week after third vaccination|This outcome was assessed in Group 3 subjects only as they provided a blood draw at 1 week following the MenACWY-CRM booster vaccination. Analysis was performed on PP booster population.|||||Number
137832|NCT00488683|Secondary|Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and third (booster) vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~The serogroup A, C, W-135 and Y specific IgG concentrations at 1 month after MenACWY-CRM booster were measured by ELISA.~hSBA GMTs were measured by hSBA assay one month after MenACWY-CRM booster vaccination.~The rise in serogroup specific IgG, memory B cells and hSBA was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x)at 12 months where x is the serogroup specific IgG or memory B cell concentrations or SBA titers."|1 month after primary and pre-third and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.~Analysis was performed on PP booster population."|||||Number
137833|NCT00488683|Secondary|Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination|"Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccinations was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~hSBA GMTs for the serogroup A, C, W-135 and Y were measured one month after the third MenACWY-CRM vaccination.~The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations one month after third MenACWY-CRM vaccination were measured by ELISA."|1 month after primary vaccination and 1 month after third vaccination|"Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months.~Analysis was performed on PP booster population."|||||Number
137834|NCT00488683|Secondary|Memory B Cells by Serogroup A, C, W-135 and Y|"Memory B cell response at 1 month after primary vaccination and immediately before third dose at 12 months of age was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC.~The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations immediately before third dose at 12 months of age were measured by ELISA."|1 month after primary vaccination and immediately before third dose|Analysis was performed on PP dataset of persistence population.|||||Number
137835|NCT00488683|Primary|Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y|"The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators.~Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose).~Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y."|1 month after primary vaccination and immediately before third dose at 12 months of age|Analysis was performed on per-protocol (PP) dataset of primary vaccination, i.e. subjects who received all the relevant doses of vaccine correctly; provided evaluable blood samples at the relevant time points; and had no major protocol violation as defined prior to analysis.||B cells per 2x100000 lymphocytes||Standard Deviation|Mean
137836|NCT00488644|Primary|Number of Participants Demonstrating Improvement With Impaired Neuro-cognitive Function (NCF) Based on Results of a Series Neuro-cognitive Exams Administered at Baseline and 8 Weeks After Liothyronine Therapy|At baseline, each participant's scores for standardized/widely-used NCF exams are recorded (recalled words/objects/sequence repetition/etc per tests listed below). After 8 weeks liothyronine therapy, participants are tested again and scores compared to baseline scores. If the participant recalls more numbers/objects/sequence repetition faster/etc., than previous scores, this constitutes an improvement in NCF function for that individual. Scores are not compared to other participants. NCF tests: Memory by RAVLT (Rey Auditory Verbal Learning Test), scored by the number of words correctly recalled at different timepoints; Attention by Digit Span Exam (accurately repeating a sequence of numbers just spoken); Processing speed by Digit Symbol Exam (accurately matching numbers with associated symbols) Executive function by Trail Making Tests and Controlled Oral Word Association; Motor dexterity evaluated by correctly placing pegs in pegboards in a specified time.|At baseline and after 8 weeks of treatment|||participants|||Number
137856|NCT00488514|Secondary|Mean Heart Rate for All Study Participants at the Indicated Time Points|A sitting heart rate was measured once for each participant at each visit.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||beats per minute||Standard Deviation|Mean
142696|NCT00443755|Secondary|Change From Baseline in Inflammatory Biomarker Tumor Necrosis Factor-alpha (TNF-α)|TNF-α is an inflammatory cytokine and is reported in picograms/milliliter (pg/mL).|Baseline, 3 month|Per-protocol analysis||pg/mL||Standard Deviation|Mean
137837|NCT00488631|Secondary|Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 54|Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
137838|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
137839|NCT00488631|Secondary|Number of Participants With Mucosal Healing at Both Week 30 and Week 54|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
137840|NCT00488631|Secondary|Number of Participants With Clinical Remission at Both Week 30 and Week 54|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.|Week 30 and Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
137841|NCT00488631|Primary|Number of Participants in Clinical Response Through Week 54|Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding subscore of >= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician’s global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.|Induction Baseline, Week 0 through Week 54|Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
137842|NCT00488592|Secondary|Clinical Response|Hematological response status|16 weeks||||||
137843|NCT00488592|Primary|Efficacy in Inducing or Boosting a Cellular Immune Response|A T-cell response was considered positive if the frequencies of interferon (IFN-γ+) cluster of differentiation (CD8+) T cells in peptide-stimulated peripheral bloody mono-nucleated cells (PBMCs) were 2-fold or more higher than the frequencies of interferon (IFN-γ+) CD8+ T cells in unstimulated PBMCs and if there was a minimum of 0.05% Interferon (IFNγ+) CD8+ T cells (after subtracting the frequencies of interferon (IFNγ+) CD8+ T cells in unstimulated PBMCs). A significant vaccine-induced CD8+ T-cell response was defined as the emergence of detectable PR1 or WT1-specific CD8+ T cells when the pre-study analysis found no response, or a 2-fold increase in frequencies when responses were present before vaccination.|16 weeks|||participants|||Number
137844|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire–Revised (PPMQ-R) at Month 12|The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).|End of Study/Month 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.||participants|||Number
137845|NCT00488514|Secondary|Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire–Revised (PPMQ-R) at the Screening Visit|The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from “very satisfied” (1) to “very dissatisfied” (7).|Screening|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.||participants|||Number
137846|NCT00488514|Secondary|Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12|The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.|Baseline and Months 3, 6, 9, and 12|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.||points on a scale||Standard Error|Mean
137847|NCT00488514|Secondary|Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting|The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||treated migraine attacks|||Number
137848|NCT00488514|Secondary|Number of Migraine Attacks Rated With the Indicated Pain Severity|The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||treated migraine attacks|||Number
137849|NCT00488514|Secondary|Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet|The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||migraine attacks|||Number
137850|NCT00488514|Secondary|Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month|The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||events||Standard Deviation|Mean
137851|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
137852|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
137853|NCT00488514|Secondary|Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet.|Baseline through End of Study (up to Month 12)|ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
137854|NCT00488514|Secondary|Number of Treated Migraine Attacks|The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John’s Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.|Baseline through End of Study (up to Month 12)|Intent-to-Treat (ITT) Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment||treated migraine attacks|||Number
137855|NCT00488514|Secondary|Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator|The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.|Screening and Final Visit (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||participants|||Number
137857|NCT00488514|Secondary|Mean Blood Pressure for All Study Participants at the Indicated Time Points|At each visit, a participant’s blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||millimeters of mercury (mmHg)||Standard Deviation|Mean
137858|NCT00488514|Secondary|Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points|BMI = (Weight in kilograms)/(height in centimeters/100)^2|Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||kilograms per meters squared||Standard Deviation|Mean
137859|NCT00488514|Secondary|Mean Weight for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||kilograms||Standard Deviation|Mean
137860|NCT00488514|Secondary|Mean Height for All Study Participants at the Indicated Time Points||Screening and Months 3, 6, 9, and 12|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary by visit, depending on the number of assessments completed at each visit.||centimeters||Standard Deviation|Mean
137861|NCT00488514|Secondary|Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||participants|||Number
137862|NCT00488514|Secondary|Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit|A shift from “normal to low,” for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL).|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.||participants|||Number
137863|NCT00488514|Secondary|Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet|The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||tablets|||Number
137864|NCT00488514|Secondary|Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet|The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
137865|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Gender|The number of participants with adverse events by gender is recorded.|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet||participants|||Number
137866|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Race|"The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White."|Baseline through End of Study (up to Month 12)|Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet||participants|||Number
137867|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Participant Age|The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
137868|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized Over Time|The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
138321|NCT00485264|Primary|Number of Participants Who Died||From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
137869|NCT00488514|Secondary|Number of Participants With Any Adverse Event Categorized by Severity|The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
137870|NCT00488514|Primary|Number of Participants With the Indicated Drug-related Adverse Events|The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE.|Baseline through End of Study (up to Month 12)|Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet||participants|||Number
137871|NCT00488488|Secondary|Overall Mortality: All Participants|Deaths for any reasons occurring during the study observation period.|Baseline to End of Treatment (up to Day 47)|All participants. Overall mortality was not calculated separately for nosocomial and community-acquired infections.||percentage of participants||95% Confidence Interval|Number
137872|NCT00488488|Secondary|Reasons for Utilization of Tygacil||Baseline to End of Treatment (up to Day 47)|All participants; n = number of participants with specified reason for utilization of Tygacil.||percentage of participants|||Number
137873|NCT00488488|Secondary|Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic|Reasons for change in antibiotic treatment from Tygacil to another antibiotic.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants with a documented therapy switch in antibiotic treatment from Tygacil to another antibiotic; n = number of participants with specified reason for switch in antibiotic treatment . Multiple specifications were possible.||percentage of participants|||Number
137874|NCT00488488|Secondary|Antibiotic Agents Chosen for Combination Therapy With Tigecycline|Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.|Baseline to End of Treatment (up to Day 47)|All participants; N = number of participants who were concomitantly treated with other antibiotics in combination with Tygacil; n = number of participants who were concomitantly treated with specified antibiotic in combination with Tygacil.||percentage of participants|||Number
137875|NCT00488488|Secondary|Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure|Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants; N = number of participants who had a follow-up microbial investigation due to treatment failure; n = number of participants who tested positive for pathogen and had isolates tested for pathogen resistance.||percentage of participants|||Number
137876|NCT00488488|Secondary|Participants With Probable Failure at Follow-up|Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.|Follow-up (up to Day 47)|All participants.||participants|||Number
137877|NCT00488488|Primary|Percentage of Participants With Composite Cure: Community-acquired Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number participants with community-acquired infections.||percentage of participants|||Number
137878|NCT00488488|Primary|Percentage of Participants With Composite Cure: Nosocomial Infections|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.||percentage of participants|||Number
137879|NCT00488488|Primary|Percentage of Participants With Composite Cure: All Participants|Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants.||percentage of participants|||Number
137880|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)|All participants; N = number of participants with community-acquired infections.||percentage of participants||95% Confidence Interval|Number
137881|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants; N = number of participants with nosocomial infections.||percentage of participants||95% Confidence Interval|Number
137882|NCT00488488|Primary|Percentage of Participants With Clinical and Microbiological Cure: All Participants|Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.|End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)|All participants: participants exposed to Tygacil who had non-retrospective post-baseline data.||percentage of participants||95% Confidence Interval|Number
137942|NCT00488293|Secondary|Clinical Course Rating Between Baseline and Month 9|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to Month 9|Clinical course rating between baseline and month 9||participants|||Number
142697|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker C-Reactive Protein (CRP)|CRP is an inflammatory cytokine and is reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis||mg/dL||Standard Deviation|Mean
137883|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) With or Without Concomitant Methotrexate (MTX) Therapy|Participants with or without concomitant methotrexate (MTX) treatment were reported for AEs or SAEs. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for specified category.||participants|||Number
137884|NCT00488475|Other Pre-specified|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred during the study.|Week 2 up to Week 52|Safety analysis population included all participants with available documentations.||participants|||Number
137885|NCT00488475|Other Pre-specified|Percentage of Participants With Low Disease Activity Determined by Disease Activity Score 28 Based on 28-joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined low disease activity was classified as a score of <=3.2.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of participants||95% Confidence Interval|Number
137886|NCT00488475|Secondary|Fatigue Visual Analog Scale (VAS)|Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Week 26, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
137887|NCT00488475|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 6, 12, 26, 38, 52|Safety analysis population included all participants with available documentations. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time points.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
137888|NCT00488475|Secondary|Patient Global Assessment of Disease Activity|Patient global assessment of disease activity was measured using a 100 mm Visual Analog Scale (VAS) ranging from 0 mm= very good to 100 mm = very bad.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
137889|NCT00488475|Secondary|Physician Global Assessment of Disease Activity|Physician global assessment of disease activity was measured on a 0 mm to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100mm = maximum possible disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
137890|NCT00488475|Secondary|Patient Global Assessment of Arthritis Pain|Participants assessed arthritis pain using a 0 mm - 100 mm Visual Analog Scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
137891|NCT00488475|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If stiffness persisted the entire day, 999 minutes was recorded [largest value possible to document] which may also include values up to 1440 minutes [= complete day]).|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||minutes||Full Range|Median
137907|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Clearance|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.|||||
137892|NCT00488475|Secondary|Percentage of Participants With Response Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|The DAS28-based European League Against Rheumatism (EULAR) response criteria was used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached (final values). Good responders: change from baseline >1.2 with DAS28 final value <=3.2; moderate responders: change from baseline >1.2 with DAS28 final values >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values <=3.2 and >3.2 to <=5.1; non-responders: change from baseline <=0.6 with DAS28 final values <=3.2, >3.2 to <=5.1 and >5.1 or change from baseline >0.6 to <=1.2 with DAS28 final values >5.1. Good and moderate responders were considered to have DAS28 response.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of participants||95% Confidence Interval|Number
137893|NCT00488475|Secondary|Percentage of Participants With Remission Determined by Disease Activity Score Based on 28-Joints Count (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 defined remission was classified as a score of <2.6.|Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of participants||95% Confidence Interval|Number
137894|NCT00488475|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||millimeter per hour (mm/h)||Standard Deviation|Mean
137895|NCT00488475|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||joints||Standard Deviation|Mean
137896|NCT00488475|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||joints||Standard Deviation|Mean
137897|NCT00488475|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm [very good] to 100 mm [very bad]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 less than (<) 2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than or equal to (>=) 3.2 to <=5.1 = moderate disease activity, DAS28 greater than (>) 5.1 = high disease activity.|Baseline, Week 2, 6, 12, 26, 38, 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||units on a scale||Standard Deviation|Mean
137898|NCT00488475|Secondary|Duration of Working Disability|"Duration of working disability was assessed as number of days a participant was disable to work. Duration of work disability was considered as 0 if participant was not disable to work during period of assessment. At baseline, participants’ duration of working disability during last 12 months before enrollment into the study was documented. After enrollment, participants’ duration of working disability was documented for last 6 months after previous documentation."|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||days||Full Range|Median
137899|NCT00488475|Secondary|Duration of Healthcare Resources Utilization|Participants’ duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants’ healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.||days||Full Range|Median
142698|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Interleukin 6 (IL-6)|IL-6 is an inflammatory cytokine and reported in picograms per deciliter (pg/dL).|Baseline, 3 months|Per protocol analysis||pg/mL||Standard Deviation|Mean
137900|NCT00488475|Secondary|Healthcare Resource Utilization|Participants’ utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants’ healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.|Baseline, Week 26, Week 52|Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points.||events||Standard Deviation|Mean
137901|NCT00488475|Secondary|Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)|WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||percentage of impairment||Standard Deviation|Mean
137902|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile. EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||units on a scale||Standard Deviation|Mean
137903|NCT00488475|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 26, Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points.||mm||Standard Deviation|Mean
137904|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52|Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as “Yes, I can perform the activity without difficulty” (score assigned = 2), “Yes, but with some difficulties” (score assigned = 1) and “No or only with help” (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100%) / (2 * number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%.|Week 52|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
137905|NCT00488475|Primary|Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26|Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as “Yes, I can perform the activity without difficulty” (score assigned = 2), “Yes, but with some difficulties” (score assigned = 1) and “No or only with help” (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of >= 83%.|Week 26|Effectiveness population included all participants >= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||percentage of participants||95% Confidence Interval|Number
137906|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Effect of Weight|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.|||||
140501|NCT00465101|Other Pre-specified|Length of Hospital Stay (LOS)|Defined as the time from admission to the healthcare facility until discharge (in hours).|Peri-Operative Period|Participants who received the study treatment and for whom the outcome measure is available.||hours||Standard Deviation|Mean
137908|NCT00488345|Primary|Percentage of Participants With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment|CR = Cure: resolution of all signs, symptoms (SS) of infection (INF) or improvement, no further antibacterial therapy (AT) necessary; Improved (IMP): SS IMP to extent that switch to oral AT deemed appropriate; Failure: lack of response, required additional AT, initial recovery then deterioration requiring further AT, death due to the INF after day 2, death due to treatment (TR)-related adverse event (AE), required non-routine surgical TR >48 hours after 1st dose of TR due to failure to IMP or clinical worsening. TOC = CR, vital signs, physical exam, laboratory results, concomitant TR, and AEs.|Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)|mITT||percentage of participants|||Number
137909|NCT00488345|Secondary|Population Pharmacokinetic (PK) Model: Volume of Distribution|Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin.|3074K4-2207: Day 3 just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose; 3074A1-110: just before and 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, and 48 hours after start of infusion|Separate population pharmacokinetic analysis results are not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.|||||
137910|NCT00488345|Primary|Weight Normalized Drug Clearance (CLW)|Weight normalized drug clearance measured in liters per hour per kilogram (L/hr/kg). Drug clearance (CL) was determined as the ratio of dose/area under the concentration-time curve from time zero (start of infusion) to 12 hours (start of next infusion) (AUCτ). CLW was determined as the ratio of CL/weight.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.||L/hr/kg||Standard Deviation|Mean
137911|NCT00488345|Primary|Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours|AUCτ: AUC between doses from time zero to the time of estimated concentration at 12 hours reported in nanograms * hours divided by milliliters (ng*h/mL) was calculated using the log-trapezoidal rule for decreasing concentrations and the linear-trapezoidal rule for increasing concentrations estimating the 12 hour drug concentration if necessary.|Day 3 (just before and immediately after infusion, and 0.75, 2, and 6 hours post-dose)|mITT; N = number of participants with sufficient reported tigecycline concentration data to estimate AUC.||ng*h/mL||Standard Deviation|Mean
137912|NCT00488345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Time of peak concentration taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|mITT; N = number of participants with evaluable tigecycline concentration data.||hours||Standard Deviation|Mean
137913|NCT00488345|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: tigecycline serum concentration measured in nanograms per milliliter (ng/mL) determined by a validated liquid chromatography with mass spectrophotometric (LC/MS/MS) detection method. Peak concentration was taken directly from the observed data.|Day 3 (immediately post-dose, 0.75, and 2 hours post-dose)|Modified intent to treat (mITT) population: participants who were screened, assigned to study medication and received at least one dose of study medication. N = number of participants with evaluable tigecycline concentration data.||ng/mL||Standard Deviation|Mean
137914|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward|Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates “Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137915|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward|Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days (“very badly” to “very well”) and how often they have felt drowsy within the previous 7 days (“not at all” to “all the time”). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates “Very badly” and a score of 100 indicates “Very well.” For daytime drowsiness, a score of 0 indicates “Not at all” and a score of 100 indicates “All the time.” Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137916|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137917|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137918|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137919|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137920|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137921|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137922|NCT00488319|Secondary|Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137923|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137940|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Symptoms Score||units on a scale||Standard Deviation|Mean
137924|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137925|NCT00488319|Secondary|Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137926|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137927|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137928|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward|A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.|Baseline, Week 24|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137929|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Children’s Global Assessment Scale (CGAS) - Last Observation Carried Forward|The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning.|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137930|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Full Range|Median
137941|NCT00488293|Primary|Skindex-16 Change Scores Baseline to Month 3 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Composite Score||units on a scale||Standard Deviation|Mean
139352|NCT00474630|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
137931|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward|Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.|Baseline, Week 104 or the last post-baseline assessment|The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137932|NCT00488319|Secondary|Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 104 or the last post-baseline assessment|The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.||Scores on a scale||Standard Deviation|Mean
137933|NCT00488319|Primary|The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability|A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to 2 years|The safety analysis set was used for the safety analyses and included all enrolled participants who received at least 1 dose of the open-label study drug as recorded on the electronic case report form. This population was considered as evaluable participants.||Number of Participants|||Number
137934|NCT00488293|Secondary|Clinical Course Rating Between Baseline and First Clinic Visit|Clinical course was assessed by review of serial digital images. The clinical course rating was provided by consensus opinion provided by a panel of three dermatologists that were not otherwise involved in the study. The rating categories were resolved, improved, unchanged - not clinically relevant, unchanged - clinically relevant, and worse.|Baseline to First Clinic Visit|Clinical course rating between baseline and first clinic visit, if a visit occurred. Timeframe varied and only applied if a first clinic visit occurred.||participants|||Number
137935|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Functioning Scores||units on a scale||Standard Deviation|Mean
137936|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Functioning Scores||units on a scale||Standard Deviation|Mean
137937|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change scores - Emotions Score||units on a scale||Standard Deviation|Mean
137938|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change score - Emotions Score||units on a scale||Standard Deviation|Mean
137939|NCT00488293|Primary|Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 3|Baseline to Month 3 Skindex-16 change score - Symptoms Score||units on a scale||Standard Deviation|Mean
138339|NCT00485173|Other Pre-specified|Neck Disability Index Score|The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
137943|NCT00488293|Primary|Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score|"Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses bother. It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant."|Baseline to Month 9|Baseline to Month 9 Skindex-16 change scores - Composite Score.||units on a scale||Standard Deviation|Mean
137944|NCT00488059|Secondary|Percentage of Patients With Ongoing Injection Site Reactions (ISRs)||Phase I and II|||Percentage of patients|||Number
137945|NCT00488059|Secondary|CD4+ Lymphocyte Count Change From Baseline|"Change from study Phase I baseline in CD4+ lymphocyte count at Phase II study Weeks II - 1, 12, 16, and LOCF by treatment arm.~Change from study Phase II baseline in CD4+ lymphocyte count at Phase II study weeks II – 12 and 16."|Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF|Intent-to-treat||cells/mm3||Full Range|Median
137946|NCT00488059|Secondary|Virologic Response Over Time in Phase II of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week.|Weeks II-4, 8, 12 & 16|intent-to-treat population||participants|||Number
137947|NCT00488059|Secondary|HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study|Change from baseline in HIV-1 RNA (log10 copies/mL) at study Weeks I-4, 8, 12 & LOCF for ITT patients in Phase I of the study|Baseline and Weeks 4, 8, 12 & LOCF|Intent-to-treat population. Last Observation Carried Forward (LOCF) includes non-missing data values from the last post-baseline visit for each participant which was carried forward to impute missing data values.||log10 copies/mL||Standard Deviation|Mean
137948|NCT00488059|Primary|Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16||Week II-16|Intent-to-treat population||participants|||Number
137949|NCT00488059|Secondary|Virologic Response Over Time in Phase I of the Study|The number of intent-to-treat (ITT) participants with HIV-1 RNA <= 50 copies/mL and HIV-1 RNA < 400 copies/mL by study week are summarized below.|Weeks 4, 8 & 12|Intent-to-treat population||participants|||Number
137950|NCT00488059|Primary|Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL|Virologic responders were defined as patients who had an initial HIV-1 RNA assessment <= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)|Between Week I-4 and Week I-12 of Phase I of the study|Intent-to-treat population||participants|||Number
137951|NCT00487981|Primary|Pain Rating at 6 Months Post Activation Compared to Baseline||6 months|||Percent reduction||Standard Deviation|Mean
137952|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline.|Baseline|Full analysis set defined as the number of subjects who had at least one observation after baseline||Participants|||Number
137953|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here.|Week 4|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
137954|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 2|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here.|Week 2|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
137955|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 1|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here.|Week 1|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
137956|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
137957|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2.|Baseline and 2 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
137958|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1.|Baseline and 1 week|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Participants|||Number
137959|NCT00487942|Secondary|Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137960|NCT00487942|Secondary|Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137961|NCT00487942|Secondary|Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137962|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores|ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
137963|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137964|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137965|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
148575|NCT00399542|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
137966|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
137967|NCT00487942|Secondary|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137968|NCT00487942|Secondary|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137969|NCT00487942|Secondary|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137970|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
137971|NCT00487942|Secondary|Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137972|NCT00487942|Secondary|Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138697|NCT00480636|Secondary|Number of Participants With Recurrent DVT|Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits|Month 6 or EOT (up to Month 6)|FAS||Participants|||Number
137973|NCT00487942|Secondary|Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137974|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores|SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline||Units on a scale||Standard Deviation|Mean
137975|NCT00487942|Secondary|Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline|The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented.|Week 4 or last observation following Baseline|Full analysis set defined as subjects who have at least one observation after Baseline||Participants|||Number
137976|NCT00487942|Secondary|Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as the number of subjects who had at least one observation after baseline||Participants|||Number
137977|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Error|Mean
137978|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137979|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at least once after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138007|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
140502|NCT00465101|Secondary|Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.||Up to five years|Participants who received the study treatment and for whom the outcome measure is available.||days||Standard Deviation|Mean
137980|NCT00487942|Secondary|Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137981|NCT00487942|Secondary|Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137982|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores|The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137983|NCT00487942|Secondary|Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
137984|NCT00487942|Secondary|Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
137985|NCT00487942|Secondary|Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
137986|NCT00487942|Secondary|Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
137987|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
137988|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138698|NCT00480636|Secondary|Percent of Participants With and Without Pulmonary Embolism (PE)|PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)|Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)|FAS. n = number of participants per PE status at observation.||Percent of participants|||Number
137989|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137990|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137991|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.||Units on a scale||Standard Deviation|Mean
137992|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137993|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137994|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score|The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.||Units on a scale||Standard Deviation|Mean
137995|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Error|Mean
137996|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137997|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
137998|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score|The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.||Units on a scale||Standard Deviation|Mean
137999|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138000|NCT00487942|Other Pre-specified|Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138001|NCT00487942|Other Pre-specified|Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138002|NCT00487942|Other Pre-specified|Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score|The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline.|Baseline and 4 weeks (or last observation after Baseline)|Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline||Units on a scale||Standard Deviation|Mean
138003|NCT00487942|Secondary|Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
138004|NCT00487942|Secondary|Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
138005|NCT00487942|Secondary|Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
138006|NCT00487942|Secondary|Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
138008|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
138009|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
138010|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
138011|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
138012|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
138013|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch).|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
138014|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch).|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
138015|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch).|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
138016|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch).|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
138017|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
138018|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
138019|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
138020|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
138021|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
138022|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint.|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline||Counts||Standard Deviation|Mean
138023|NCT00487942|Secondary|Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4.|Baseline and Week 4|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4||Counts||Standard Deviation|Mean
138024|NCT00487942|Secondary|Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3.|Baseline and Week 3|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3||Counts||Standard Deviation|Mean
138025|NCT00487942|Secondary|Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2.|Baseline and Week 2|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2||Counts||Standard Deviation|Mean
138026|NCT00487942|Secondary|Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1.|Baseline and Week 1|Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1||Counts||Standard Deviation|Mean
138027|NCT00487942|Secondary|Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity|An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch).|Baseline and Week 4 or last observation after baseline|Full analysis set defined as subjects who had a baseline and at least one post-baseline assessment by actigraphy||Counts||Standard Deviation|Mean
138028|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test|Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Minutes||Standard Deviation|Mean
138029|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Categories Completed||Standard Deviation|Mean
138063|NCT00487578|Primary|Mental Efficiency Workload Test (MEWT) Performance Index Score|Cognitive function as measured by Performance Index scores on the Mental Efficiency Workload Test (MEWT). On the performance index scale of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. Tests include: Simple reaction time, Running memory, Matching to sample, Math processing and a sleep scale.|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
138030|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed."|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Responses||Standard Deviation|Mean
138031|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors|"WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed."|4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Errors||Standard Deviation|Mean
138032|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138033|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138034|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138035|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138036|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138037|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138038|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138039|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138040|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138041|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138042|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline.|Baseline and 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138064|NCT00487578|Primary|Headache Impact Test-6 (HIT-6) Score|Impact of headache symptoms on subject's life as measured by HIT-6 questionnaire scores. Possible scores range from 36 to 78. Score of 48 or less indicates headache has little impact on life. Score of 60-78 indicative of very severe impact.|Day 0, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
138065|NCT00487578|Primary|Headache Days|Number of headache days as measured by the Headache Diary|Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
138043|NCT00487942|Secondary|Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline.|Baseline 4 weeks (or last observation after baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138044|NCT00487942|Secondary|Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks.|Baseline and 4 weeks|Full analysis set defined as subjects who received one or more doses of the study drug and who had a MATRICS efficacy assessment at baseline and at Week 4. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138045|NCT00487942|Primary|Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery|The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.|Baseline and 4 weeks (or last observation after Baseline)|Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.||Units on a scale||Standard Deviation|Mean
138046|NCT00487825|Secondary|The Number of Participants in Clinical Remission Based on Disease Activity Score (DAS)28 and Simplified Disease Activity Index (SDAI)|"At each visit (including baseline) the DAS28 and SDAI variables were derived using the following formulas:~DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; SDAI = tender28 + swollen28 + CRP + (PGDA / 10) + (EGDA / 10) where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, CRP is C-reactive protein, PGDA is the patient’s global assessment of disease activity and EGDA is the physician’s global assessment of disease activity.~The Number of Participants in clinical remission is defined as the DAS28 ≤ 2.6 or SDAI ≤ 3.3."|At 6 weeks, 14 weeks and 24 weeks|Intention to treat (ITT) population||Participants|||Number
138047|NCT00487825|Secondary|Percentage of Participants Achieving a Good European League Against Rheumatism (EULAR) Response (Based on the Disease Activity Score (DAS28)) at 26 Weeks|At each visit (including baseline) the DAS28 is derived as: DAS28 = 0.56*√ (tender28) + 0.28 * √ (swollen28) + 0.36 * loge(CRP+1) + 0.014*PGDA+ 0.96; where tender28 is the tender 28-joint count, swollen28 is the swollen 28-joint count, PGDA is the patient’s global assessment of disease activity. Patients can be scored on a range of 0 to 10. When current DAS < 3.2, good response is defined as >1.2 improvement in DAS from baseline and non-response is improvement of ≤0.6. When current DAS >5.1, non-response is improvement of >0.6 but ≤1.2 . All others are moderate responses.|At 26 weeks|Intention to treat (ITT) population||Percentage of Participants|||Number
138048|NCT00487825|Secondary|Response to Intravenous (IV) Canakinumab and Oral Methotrexate (MTX) Therapy (ACR20, 70, 90) Compared to MTX Alone|"A patient was considered as improved according to the criteria of ACR 20 equaling at least 20%, ACR70 = 70%, and ACR90 = 90% improvement in the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient’s global assessment of disease activity (VAS 100 mm)~Physician’s global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|At 6 weeks, 14 weeks, and 26 weeks|Intent-to-treat population (ITT)||Participants|||Number
138049|NCT00487825|Primary|Response to Intravenous Canakinumab and Oral Methotrexate (MTX) Compared to MTX Alone as Determined by 50% Improvement in Symptoms According to the American College of Rheumatology Criteria (ACR50)|"A patient was considered as improved according to the ACR50 criteria if she/he had at least a 50 % improvement in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient’s global assessment of disease activity (VAS 100 mm)~Physician’s global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein (hsCRP))"|6, 14, and 26 weeks of treatment|Intent-to-treat population (ITT)||Participants|||Number
138066|NCT00487565|Primary|Knee Active Flexion|Active flexion is measured by how much a patient can bend their knee on their own, without assistance.|12 month|||degrees||Standard Deviation|Mean
138067|NCT00487552|Post-Hoc|Success Rate of Mature Anastomosis Creation Using Magnetic Anastomosis Device (MAD)|Endoscopy was performed to determine whether an anastomosis (hole) was successfully created.|Approximately 8-10 days|Patients who underwent a second endoscopy after successful magnet placement||participants|||Number
143085|NCT00442962|Secondary|Percentage of Participants With Late Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 48|Participants with plasma HIV-1 RNA viral load result available from week 48 study visit.||percentage||95% Confidence Interval|Number
138050|NCT00487721|Primary|Measurable Silibinin Tissue Levels|To determine if measurable silibinin tissue levels are detectable in the prostate glands of men treated with Silybin-Phytosome administered according to the protocol. Analysis of silibinin in human fluid and tissue samples was carried out by Liquid chromatography - mass spectrometric (LC/MS/MS) following liquid extraction. Briefly, sample was extracted in acidified ethyl acetate by vortex. Following centrifugation, the organic layer was evaporated to dryness in a rotary evaporator and the samples were dissolved in acetonitrile/ammonium acetate with acetic acid for analysis. Sample analysis was done using an Applied Biosystems 3200 Q-Trap 1 triple quadrupole mass spectrometer with an Agilent 1100 Liquid Chromatography system and HTC-PAL Leap Autosampler. Quantitation of silibinin in samples was done by internal standard reference and batch analysis verified by the inclusion of spiked quality control samples in the appropriate matrix.|At the time of surgery|Per protocol analysis was used and 6 participants that were enrolled in the study were included in the analysis.||Participants|||Number
138051|NCT00487695|Secondary|Mean Number of Biopsies Taken in Barrett's Surveillance Patients|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete, the study, no comparison could be made. The patients in this analysis were referred for surveillance of Barrett's esophagus (no suspected neoplasia).||mean number of biopsies||Full Range|Mean
138052|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.||number of biopsies with neoplasia||Full Range|Mean
138053|NCT00487695|Secondary|Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients|Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia).|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed).||percent yield for neoplasia|||Number
138054|NCT00487695|Secondary|Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)|The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia.|6 weeks|per protocol as participants would only have data to compare if they completed both endoscopies||mean number of biopsies||Full Range|Mean
138055|NCT00487695|Secondary|Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)|The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia.|6 weeks|Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.||mean number of biopsies with neoplasia||Full Range|Mean
138056|NCT00487695|Primary|Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)|The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)|6 weeks|Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed. This analysis looks specifically at patients with Barrett's and suspected (but not known) neoplasia.||percent yield for neoplasia|||Number
138057|NCT00487669|Secondary|Overall Survival||time from study entry until death|||months||95% Confidence Interval|Median
138058|NCT00487669|Secondary|Time to Progression||time from study entry until the first documented sign of progression|||months||95% Confidence Interval|Median
138059|NCT00487669|Primary|To Evaluate the Overall Response Rate (Complete Plus Partial Responses by RECIST Criteria) to the Combination of Paclitaxel Poliglumex and Pemetrexed as Therapy in Patients With Advanced NSCLC.||CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)|||participants|||Number
138060|NCT00487578|Secondary|Sustained Treatment Effect|Sustained treatment effect as measured by the MEWT Performance Index score compared to change in number of Headache Days. Results would be presented in the form of a correlation analysis. There is an expected negative correlation as performance index increases and number of headache days decrease (a correlation of -1).|Day 0, Day 10, Day 30|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
138061|NCT00487578|Secondary|Quality of Life Scores|"Quality of life as measured by Migraine Specific Quality of Life questionnaire (MSQ) scores. 14 questions ask how often headaches have interfered with specific daily activities in previous 4 weeks. 6-point scale ranges from None of the time to All of the time."|Day 0, Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
138062|NCT00487578|Secondary|Overall Satisfaction With Medication Score|Subject overall satisfaction with effectiveness of the therapy as measured by score on the Satisfaction with Medication questionnaire. Scale range: Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied.|Day 30, Day 90|No analysis was conducted. Study terminated due to expiration of study medication and low enrollment.|||||
138068|NCT00487552|Primary|Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent|Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.|Approximately 8-10 days|||participants|||Number
138069|NCT00487539|Secondary|Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6|The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.|Baseline to Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a Scale||Standard Deviation|Mean
138070|NCT00487539|Secondary|Number of Participants With Mucosal Healing at Week 6|Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.||Participants|||Number
138071|NCT00487539|Secondary|Number of Participants With Clinical Remission at Week 6|Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.||Participants|||Number
138072|NCT00487539|Primary|Number of Participants With Clinical Response at Week 6|Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.|Baseline, Week 6|Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.||Participants|||Number
138073|NCT00487461|Secondary|To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.|6 months|Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.|||||
138074|NCT00487461|Primary|To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH||21 days|Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.|||||
138075|NCT00487435|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The subjects indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, 52 weeks|observed cases||Scores on a Scale||Standard Deviation|Mean
138076|NCT00487435|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of subjects who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized subjects who took at least one dose of study medication).||participants|||Number
138077|NCT00487396|Secondary|The Additional Diagnostic Value and Sensitivity of CE Compared With Ileo-colonoscopy and SBFT Will be Evaluated by the Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related.||four months from enrollment||||||
138078|NCT00487396|Secondary|Small Bowel Disease Present (Will be Categorized as Mild, Moderate or Severe)or Suspicious for Small Bowel Disease or No Small Bowel Disease Present.||four months from enrollment||||||
138079|NCT00487396|Primary|The Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related|The number of positive findings related to Crohn that were detected by capsule endoscopy procedure and ileo-colonoscopy as compared to the number of findings related to Crohn that were detected by ileo-colonoscopy and small bowel follow through(SBFT) procedures.|four months from enrollment|Findings were catagorized (ulcers, inflammatory lesions, stricturing lesions and others) and for each category, the numbers of found and missed pathologies, i.e. the detection capabilities, were calculated for the combination of the procedures (i.e. CE and IC vs. SBFT and IC) and were limited to one count per location (SB, terminal ileum, colon).||Number of findings|||Number
138080|NCT00487279|Secondary|Arrhythmic Mortality|Arrhythmic mortality was reported as the number of randomized patients who died due to arrhythmic death. Arrhythmic death was defined as death due to arrhythmia or sudden death.|Total survival will be evaluated 2 years after the last patient is randomized.|||participants|||Number
138081|NCT00487279|Primary|All-cause Mortality||Total survival will be evaluated 2 years after the last patient is randomized.|Intent to Treat||participants|||Number
138082|NCT00487240|Secondary|Insulin Dose (Total and By Component [Basal and Bolus])|Total daily insulin dose (U/day) was assessed.|32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||units of insulin per day (U/day)||Standard Deviation|Mean
138083|NCT00487240|Secondary|Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])|Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||units of insulin per kilogram per day||Standard Deviation|Mean
138086|NCT00487240|Secondary|1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|baseline to 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||hypoglycemic events per 1 year||Standard Deviation|Mean
138087|NCT00487240|Secondary|Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint|Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of <2.8 mmol/L (<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.|Baseline to 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||episodes of hypoglycemia|||Number
138088|NCT00487240|Secondary|Glycemic Variability at Endpoint|Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose [SMBG] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
138089|NCT00487240|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint|Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.|32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
138090|NCT00487240|Secondary|Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%||32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||percentage of participants|||Number
138091|NCT00487240|Secondary|Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values|"The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. [Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline."|Baseline, 8,16, 24, 32 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.||percent of HbA1c||Standard Error|Least Squares Mean
138092|NCT00487240|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint||baseline and 32 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||percent of HbA1c||Standard Error|Least Squares Mean
138093|NCT00487188|Secondary|Number of Participants With Adverse Events (AEs) During the Induction Phase|A serious AE (SAE) is an event which: results in death, is life-threatening, disabling or incapacitating; is a congenital anomaly in the offspring of a patient who received study drug; requires or prolongs inpatient hospitalization; jeopardizes the patient or require medical or surgical intervention to prevent one of the outcomes above; any Grade 4 laboratory value considered by the investigator clinically significant or that requires an action; any injection site reaction that meets SAE criteria above. Non-serious AEs reported include pneumonia and non-serious AEs that led to discontinuation.|Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32)|Safety Population||participants|||Number
138094|NCT00487188|Secondary|Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase|Improvement of CD4+ count defined as having from 100 to less than 200 CD4+ cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of ≥100 to <200 cells/mm^3.||percentage of participants|||Number
138095|NCT00487188|Secondary|Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase|Maintenance of CD4+ count defined as having greater than or equal to 200 cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.|Baseline 2 to Week 48.|Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of greater than or equal to 200 cells/mm^3.||percentage of participants|||Number
138096|NCT00487188|Secondary|Number of Participants With Virological Failure During the Maintenance Phase|Virological failure was defined by 2 consecutive HIV-1 RNA values ≥ 400 copies/mL during the Maintenance Phase.|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)||Participants|||Number
138097|NCT00487188|Secondary|Time to Virological Failure During the Maintenance Phase|"Time to virological failure (defined as HIV-1 RNA ≥ 400 copies/mL) was counted from Baseline 2 until the first of the two consecutive ≥400 copies/mL measurements.~Only patients who were qualified for entering the Maintenance Phase were included in the analyses."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)||days||Inter-Quartile Range|Median
138098|NCT00487188|Secondary|Time to Loss of Viral Response During the Maintenance Phase|"The time to loss of viral response (defined as HIV-1 RNA <50 copies/mL) was counted from Baseline 2 until the first of two consecutive ≥50 copies/mL measurements.~Only patients who were qualified for entering the Maintenance Phase were included in the analysis."|From Baseline 2 to Week 48.|Maintenance Phase Intent-to-Treat Population 2 (ITT2)||days||Inter-Quartile Range|Median
138439|NCT00484094|Secondary|Estimated Glomerular Filtration Rate (eGFR) Calculated by Nankivell Formula|Graft function was evaluated by eGFR using Nankivell formula. The investigator recorded the date of evaluation and the calculated value on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set.||mL/min||Full Range|Median
138099|NCT00487188|Secondary|Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts|Change from Baseline in CD4 Cell Counts at Week 48. Least squares means were calculated from an ANCOVA model with treatment and baseline CD4 count as independent variables.|Baseline 1 and Week 48|Intent-to-Treat Population 2 (ITT2) population (patients evaluable for efficacy in the Maintenance Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 48 or who withdrew prior to the week 48 time window.||cells/mm^3||95% Confidence Interval|Least Squares Mean
138100|NCT00487188|Secondary|Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Maintenance Phase who maintained HIV-1 RNA < 50 copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Maintenance Phase Intent-to-Treat Population 2 (ITT2).||percentage of participants|||Number
138101|NCT00487188|Secondary|Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks|The percentage of participants from the Induction Phase who maintained HIV-1 RNA < 50 Copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.|Week 48|Induction Phase Intent-to-Treat Population 1 (ITT1).||percentage of participants|||Number
138102|NCT00487188|Secondary|Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts|Change from Baseline in CD4+ Cell Counts at Week 24. Least squares means were calculated from an ANCOVA model with treatment as an independent variable.|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.||cells/mm^3||95% Confidence Interval|Least Squares Mean
138103|NCT00487188|Secondary|Change From Baseline to Week 24 in Viral Load|"Change from Baseline in log10 HIV-1 RNA at Week 24. Least squares means were calculated from an analysis of covariance (ANCOVA) model with treatment, a flag variable removed ENF at re-randomization and Baseline viral load as independent variables."|Baseline and Week 24|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.||log10 copies/mL||95% Confidence Interval|Least Squares Mean
138104|NCT00487188|Secondary|Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 400 copies/mL) by Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by Week 28 were considered as non-responders.|From Baseline 1 to Week 28|ITT1 population (patients evaluable for efficacy in the induction phase)||Participants|||Number
138105|NCT00487188|Secondary|Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase|"The time to achieving HIV-1 RNA <50 copies/mL was counted from Baseline 1 until the first of the two consecutive <50 copies/mL measurements.~Patients who discontinued from the study or patients who did not have confirmed virological response by week 28 were classed as non-responders and censored at Week 24."|Baseline 1 until Week 28.|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase).||days||Inter-Quartile Range|Median
138106|NCT00487188|Primary|Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase|Participants whose viral load achieved suppression (HIV-1 RNA < 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.|From Baseline 1 to Week 28|Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase)||Participants|||Number
138107|NCT00487162|Secondary|Hemodynamic Instability||0-48 hours post op|no analysis was done as the study was terminated due to patient safety concerns|||||
138108|NCT00487162|Primary|Wound Infection||7-10 days post op|no analysis was done as the study was terminated due to patient safety concerns|||||
138109|NCT00487084|Secondary|Supplemental Analgesia in First 48 Hours|Participants requesting supplemental analgesia in first 48 hours|48 hours|||Participants|||Number
138110|NCT00487084|Primary|Supplemental Analgesia in First 90 Minutes|Participants requesting supplemental analgesia in the first 90 minutes following study drug|90 min|||participants|||Number
138111|NCT00487084|Secondary|Verbal Rating Score (0 to 10) for Pain (VRPS)|Verbal Rating Pain Score (VRPS) at time of post-anesthesia recovery room entry, where 0 = no pain and 10 = worst pain imaginable|At recovery room entry|Verbal Rating Score for Pain (0-10) where 0 = no pain and 10 = worst pain imaginable||Scores on a scale||Inter-Quartile Range|Median
138112|NCT00487084|Primary|Duration of Continuing Analgesia|Time to first request for supplemental analgesia|48 hours|All participants receiving the intervention were analyzed||hours||95% Confidence Interval|Median
138113|NCT00486954|Secondary|Number of Participants With Mutations That May Correlate With Response and Toxicity to Lapatinib|An inadequate number of tissue samples were obtained; thus, analysis could not be performed.|Pretreatment|ITT Population|||||
138114|NCT00486954|Secondary|Number of Participants With the Indicated Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry Intensity in the Randomized Part of the Study|"HER2 protein expression on the surface of cells in gastric cancer tissue samples was measured using a monoclonal antibody specific for the extracellulr region of HER2, and the degree of membrane staining was evaulated. The immunohistochemistry test gives a score of 0 to 3+ and measures the amount of HER2 receptor protein on the surface of cells in a gastric cancer tissue sample. Score of 0 to 1+, HER2 negative; score of 2+, borderline; score of 3+, HER2 positive."|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.||participants|||Number
138180|NCT00486863|Secondary|Mean Change in Maternal Weight From 14 to 32 Weeks Gestation|Maternal weight gain was assessed by measuring participants' weight in kilograms. The weight increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom weight was reported at both timepoints were included in this analysis.||kilograms||Standard Deviation|Mean
138115|NCT00486954|Secondary|Number of Participants With the Indicated Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry Intensity in the Randomized Part of the Study|EGFR protein expression on the surface of cells in gastric cancer tissue samples was measured using a moncolonal antibody specific for the extracellular region of EGFR, and the degree of membrane staining was evaluated. 3+ indicates positive EGFR expression; <3+ indicates negative EGFR expression.|Pretreatment|ITT Population. Only those participants for whom immunohistochemistry testing was conducted were analyzed.||participants|||Number
138116|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Hair Loss Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138117|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Body Image Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138118|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Taste Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138119|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dry Mouth Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138120|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Anxiety Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138121|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Eating Restrictions Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138122|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Reflux Symptoms Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138123|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Pain Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
145080|NCT00427635|Secondary|Change From Baseline in Number of Liquid Acidic Reflux Episodes|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
138124|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-STO22 Dysphagia Scale Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-STO22 is a 22-item, self-reporting instrument consisting of 5 scales and 4 single items to assess health-related quality of life (HRQOL) issues related to dysphagia, eating restrictions, reflux, and abdominal pain, as well as specific symptoms that may occur during chemotherapy or radiation treatment. Scores are averaged and transformed to a 0-100 scale. For the symptom scales and items, a high score is equivalent to worse or more symptoms. In the functional scales, however, a high score is equivalent to better function.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138125|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138126|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Diarrhea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138127|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Constipation Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138128|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Appetite Loss Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138129|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Insomnia Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138130|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Dyspnea Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138131|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138195|NCT00486811|Secondary|Sleep Questionnaire: Amount of Time Slept in Hours|"The Sleep Questionnaire addressed the following question: How long did you sleep last night?. The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied."|Baseline to Week 12 of the maintenance period|Intention to treat (ITT). Last Observation Carried Forward (LOCF)||hours||Standard Deviation|Mean
138132|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138133|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Symptom Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138134|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Social Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138135|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138136|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138137|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Role Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138138|NCT00486954|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
138139|NCT00486954|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QOL Score at the End of Therapy in the Randomized Part of the Study|The EORTC QLQ-C30 is a 30-item, self-reporting questionnaire assessing 15 domains (5 functional scales [physical/role/emotional/cognitive/social]; 9 symptom scales [fatigue/nausea and vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea/financial difficulties]; GHS/QOL scale). Participants assessed most statements on a 4-point scale (1, not at all; 4, very much); two questions used a 7-item scale (1, poor; 7, excellent). Scores were averaged and transformed to a 0-100 scale. A high score indicates both a high/healthy level of functioning and a high level of symptoms/problems.|Baseline and end of therapy (up to 42.58 months)|ITT Population. Only those participants who contributed data were analyzed.||scores on a scale||Standard Deviation|Mean
140521|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 8|(Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window||percent change||95% Confidence Interval|Least Squares Mean
138140|NCT00486954|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Adverse Events (AEs) for Which All Grades of the AE Were Reported in >=10% of Participants, Regardless of Causality in the Randomized Part of the Study|The Common Terminology Criteria for Advere Events (CTCAE) is a descriptive terminology that can be used for AE reporting. Grade (G) refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade (G) refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE.|From the first dose of investigational product to 30 days after the last dose (up to 110.3 weeks in the Randomized part)|Safety Population: all participants who were randomized and took at least one dose of study medication||participants|||Number
138141|NCT00486954|Secondary|Duration of Response in the Randomized Part of the Study|Duration of response was defined as the time from the first documented evidence of CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD) until the first documented sign of disease progression (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions) or death due to any cause, if sooner.|up to 18.27 months|ITT Population. Only those participants achieving a CR or PR were assessed.||months||95% Confidence Interval|Median
138142|NCT00486954|Secondary|Number of Participants With the Indicated Time to Response in the Randomized Part of the Study|Time to response was defined as the time from randomization to CR (the disappearance of all target lesions) or PR (a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD). For participants who did not achieve a CR or PR, time to response was censored at the last assessment prior to other cancer therapies. For censored participants, time to response was defined as the time from randomization to the time of the last assessment prior to the administation of other cancer therapies.|up to 5.62 months|ITT Population. Only those participants achieving a CR or PR were assessed.||Participants|||Number
138143|NCT00486954|Secondary|Percentage of Participants With Overall Response in the Randomized Part of the Study|Overall response was defined as the percentage of participants achieving either complete response (CR) or partial response (PR). Per RECIST, version 1.0, CR was defined as the disappearance of all target lesions, and PR was defined as a greater than 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|From randomization up to 5.62 months|ITT Population||Percentage of participants|||Number
138144|NCT00486954|Secondary|Time to Progression in the Randomized Part of the Study|Time to progression was defined as the time from randomization until the earliest date of disease progression or death due to disease. Per RECIST, version 1.0, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to disease (up to 42.35 months )|ITT Population||months||95% Confidence Interval|Median
138145|NCT00486954|Secondary|Progression-free Survival (PFS) in the Randomized Part of the Study|PFS was defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|From randomization until disease progression or death due to any cause (up to 42.35 months)|ITT Population. For participants whose disease did not progress or who did not die, PFS was censored at the time of the last independently assessed radiological scan preceding the initiation of any alternate anti-cancer therapy.||months||95% Confidence Interval|Median
138146|NCT00486954|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Vss is the volume of distribution at steady state of paclitaxel.|Days 1 and 8|PK Parameter Population||liters per square meter||95% Confidence Interval|Geometric Mean
138147|NCT00486954|Secondary|Clearance of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Clearance is defined as the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Days 1 and 8|PK Parameter Population||liters per hour per square meter||95% Confidence Interval|Geometric Mean
138148|NCT00486954|Secondary|Half-life of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half.|Days 1 and 8|PK Parameter Population||hr||95% Confidence Interval|Geometric Mean
138149|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-inf) is area under the plasma concentration-time curve from the start of infusion (time 0) extrapolated to infinity.|Days 1 and 8|PK Parameter Population||hr*ng/mL||95% Confidence Interval|Geometric Mean
138150|NCT00486954|Secondary|AUC(0-24) of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8. AUC is defined as the area under the paclitaxel concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from the start of infusion (time 0) to 24 hours after the start of the infusion.|Days 1 and 8|PK Parameter Population||hr*ng/mL||95% Confidence Interval|Geometric Mean
138151|NCT00486954|Secondary|Tmax of Paclitaxel in the Pilot Part of the Study|PK samples were collected just before the start of infusion and 0.5, 1.0 (immediately before terminating the infusion), 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 1 and 8.|Days 1 and 8|PK Parameter Population||hr||Full Range|Median
138153|NCT00486954|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14. AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after oral adminisation.|Days 8 and 14|PK Parameter Population||hr*ng/mL||95% Confidence Interval|Geometric Mean
138154|NCT00486954|Secondary|Time to Cmax (Tmax) of Lapatinib in the Pilot Part of the Study|PK samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population||hours (hr)||Full Range|Median
138155|NCT00486954|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib in the Pilot Part of the Study|Pharmacokinetic (PK) samples were collected at pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose on Days 8 and 14.|Days 8 and 14|PK Parameter Population: all participants for whom the PK parameter could be estimated||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
138156|NCT00486954|Primary|Overall Survival (OS) in the Randomized Part of the Study|OS was defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. For censored participants, time to death was defined as the time from randomization to the time of last contact.|From randomization until death due to any cause (up to 42.58 months)|Intent-to-Treat Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication||months||95% Confidence Interval|Median
138157|NCT00486954|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study|DLTs consisted of only drug-related toxicities (neurologic and non-neurologic DLTs). A neurologic DLT was defined as grade 3/4 clinically significant peripheral motor and/or sensitive neuropathy. Non-neurologic DLTs mainly included the following: grade 3/4 clinically significant non-hematological toxicity (except nausea), grade 4 neutropenia lasting >=7 days, thrombocytopenia (<=25000 cells per cubic millimeter), inability to begin next treatment within 2 weeks of scheduled dosing due to unresolved toxicity, treatment delay (due to toxicity) of >5 days, for Days 8 or 15 of weekly paclitaxel.|28 days|Safety Population (Pilot part): all participants who received at least one dose of investigational product in the Pilot part of the study||Participants|||Number
138158|NCT00486902|Post-Hoc|Pain Score (0-10) at 2 Weeks Following Cesarean Delivery|Numeric rating for pain score (0 to 10) reported at 2 weeks following cesarean delivery. Zero is no pain and 10 is worst pain imaginable.|2 weeks|||Scores on a scale||Inter-Quartile Range|Median
138159|NCT00486902|Secondary|Disturbing Dreams|Number of subject reporting disturbing dreams at 72 hours post cesarean delivery|72 hours|||participants|||Number
138160|NCT00486902|Secondary|Postperative Pruritus|Number of subjects with pruritus in the first 24 hours following cesarean delivery|24 hours|||participants|||Number
138161|NCT00486902|Secondary|Postoperative Vomiting|Number of subjects that vomited in the first 24 hours following cesarean delivery|24 hours|||participants|||Number
138162|NCT00486902|Secondary|Postoperative Nausea|Number of subjects reporting nausea in first 24 hours following cesarean delivery|24 hours|||participants|||Number
138163|NCT00486902|Secondary|Cumulative Hydrocodone/Acetaminophen for Supplemental Analgesia to Treat Breakthrough Pain|Cumulative hydrocodone/acetaminophen for supplemental analgesia to treat breakthrough pain for 72 hours following cesarean delivery|72 hours|Analysis was per protocol||tablets||Inter-Quartile Range|Median
138164|NCT00486902|Secondary|Verbal Pain Scores (0 to 10) at First Analgesia Request|Numeric rating of pain scores (NRS) scale (0 to 10) at time of supplemental analgesia request. Zero is no pain and 10 is worst pain imaginable.|24 hours|||Scores on a scale||Inter-Quartile Range|Median
138165|NCT00486902|Primary|Number of Subjects Requiring Supplemental Analgesia in the First 24 Hours Following Cesarean Delivery|Request for oral hydrocodone/acetaminophen for pain not controlled by around the clock non-steroidal antiflammatory drugs in the first 24 hours following cesarean delivery.|24 hours|Analysis was performed per protocol||participants|||Number
138166|NCT00486863|Secondary|4-hydroxy Praziquantel Pharmacokinetic Concentrations|Since pregnancy is associated with increased cytochrome P450 activity and physiologic changes in the gastrointestinal tract that tend to reduce drug absorption, praziquantel pharmacokinetics may be affected by pregnancy. Thus, the metabolite-to-parent drug ratio may serve as a differential marker to help determine if variability in drug exposure following oral administration during pregnancy is due to altered metabolism or drug absorption. Samples that were collected from subjects who were randomized to receive praziquantel were analyzed for praziquantel and 4-hydroxy praziquantel concentrations. Assays were performed using high performance liquid chromatography–electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory. Descriptive statistics were obtained for concentrations at each of the four sparse sampling timepoints.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).||ng/ml||Inter-Quartile Range|Median
138178|NCT00486863|Secondary|Newborn Median Serum Transferrin Receptor:Ferritin Ratio|To assess total body iron, the serum transferrin receptor:ferritin ratio was assessed in the infant. At delivery, a heel stick blood sample and a cord blood sample were collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio.|0-6 days after delivery.|All infants for whom transferrin receptor and ferritin were reported are included in the analysis.||ratio||Inter-Quartile Range|Median
138179|NCT00486863|Secondary|Mean Change in Maternal Thigh Skinfold Thickness From 14 to 32 Weeks Gestation|Maternal fat stores were measured by thigh skinfold thickness obtained using a Holtain skinfold caliper. The thickness increase from 14 to 32 weeks was determined for each participant, and the mean and standard deviation calculated.|14 and 32 weeks gestation|All participants for whom thigh skinfold thickness was reported at both timepoints were included in this analysis.||millimeters||Standard Deviation|Mean
139353|NCT00474630|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
138167|NCT00486863|Secondary|Praziquantel Pharmacokinetic Concentrations|Two plasma samples were collected during the overnight hospitalization from approximately 200 subjects that remained at the time of study modification to incorporate PK studies. Subjects had samples collected based on one of two sample collection strategies: 4.5 and 8 hr after the first praziquantel dose or 6 and 10 hr after the first praziquantel dose. Subjects randomized to an even study number were assigned to the 4.5 and 8 hour schedule. Subjects randomized to an odd study number were assigned to the 6 and 10 hour schedule. Samples only from subjects randomized to receive praziquantel were analyzed for praziquantel. Samples drawn from subjects randomized to the control group were not analyzed. Praziquantel concentrations (ng/ml) were assayed using high performance liquid chromatography–electrospray mass spectrometry in the University of California at San Diego Pediatric Clinical Pharmacology Laboratory.|4.5 and 8 hours after the first praziquantel dose (subjects assigned to an even study number) or 6 and 10 hours after the first praziquantel dose (subjects assigned to an odd study number).|The analysis population for pharmacokinetics descriptive analyses was defined as all subjects who had plasma samples collected and who were randomized to receive PZQ (N=99; 50 subjects at 4.5 and 8 hr after first PZQ dose and 49 at 6 and 10 hr after first PZQ dose).||ng/mL||Inter-Quartile Range|Median
138168|NCT00486863|Secondary|Cytokeratin 18 Neo-epitope Staining as a Measure of Apoptosis|A study hypothesis was that peripheral serum obtained from S. japonicum infected, treated mothers would induce a lower level of apoptosis (programmed cell death) in cultured trophoblasts as measured by cytokeratin 18 neo-epitope staining compared to peripheral serum obtained from S. japonicum infected, PZQ untreated mothers. This assay was planned to be completed only if the primary objective was met; therefore, there will be no data for this outcome measure.|32 weeks gestation||||||
138169|NCT00486863|Secondary|Placental Blood Cytokine Levels|Cytokine assays were planned to be performed with culture supernatant harvested from placental explant cultures. The cytokines were to be measured with a multi-analyte analyzer. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At delivery||||||
138170|NCT00486863|Secondary|Maternal Serum Cytokine Levels of TNF-alpha, TNF-alpha Receptors I and II, IL-1, and IL-6|Extra-placental mechanisms mediating improved outcomes in the PZQ group were planned to be evaluated with maternal serum cytokine levels, particularly TNF-alpha, TNF-alpha receptors I and II, IL-1, and IL-6. These assays were intended to be performed only if the primary objective of the study was met; therefore, there will be no results reported for this outcome measure.|At 32 weeks gestation||||||
138171|NCT00486863|Secondary|Number of Participants With Pre-eclampsia|Participants were assessed for the presence of pre-eclampsia at both the 22 and 32 week visits. Pre-eclampsia was defined by the presence of proteinurea (2+ protein on urine dipstick) and a single diastolic blood pressure reading of 100 millimiters of mercury (mm Hg) or above OR more than one reading, four hours apart, of 90 mm Hg or above.|22 weeks and 32 weeks|All participants seen at both timepoints are included.||participants|||Number
138172|NCT00486863|Secondary|Number of Participants Whose Infant Was Born With Congenital Anomalies|The newborn was examined by the midwife at delivery and within 2-6 days of delivery to assess the presence of congenital anomalies and well-being. The newborn was also examined by study pediatrician at 28 days of life.|At delivery, within 2-6 days of delivery, and at 28 days|All newborns are included in the analysis.||participants|||Number
138173|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Clinical Chemistry Assessments Within 24 Hours of Dosing|Toxicity to maternal kidney and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. Any values that were 1.1 times the upper limit of normal or greater for the parameter were considered abnormal.|Just before and 24 hours after dosing|All participants were included in this analysis.||participants|||Number
138174|NCT00486863|Secondary|Number of Participants Reporting Abnormalities in Hematology Assessments Within 24 Hours of Dosing|Toxicity to maternal bone marrow, kidney, and liver was assessed by laboratory parameters collected just before and 24 hours after dosing. Specifically, blood was drawn just before the dose at 12-16 weeks gestation to determine baseline complete blood count, including white blood count (WBC), platelets, and hemoglobin. Blood was then drawn 24 hours after the second part of the split dose and before discharge from the hospital to assess any changes in these parameters. White blood count was abnormal at or above 10,800 or at or below 3500 cells/square millimeter (sq mm), platelets were abnormal at or below 140,000 cells/sq mm, and hemoglobin was abnormal at or below 10.9 grams/deciliter (g/dL).|Just before and 24 hours after dosing|All participants were included in this analysis.||participants|||Number
138175|NCT00486863|Secondary|Number of Participants Experiencing Fetal Loss by Abortion|Abortion was defined by the protocol as bleeding followed by fetal loss as supported by ultrasound before 20 weeks gestation. Abortion was an important safety outcome measure due to the fact that abortion would occur closer to the time of dosing than miscarriage or stillbirth. Participants were observed in hospital for 24 hours after dosing and asked to return for any bleeding at any time.|After dosing and before 20 weeks gestation|All participants were included in this analysis.||participants|||Number
138176|NCT00486863|Secondary|Number of Participants Reporting Serious Adverse Events Within 24 Hours of Dosing|Participants were observed in hospital for 24 hours after dosing for serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof (for reasons other than the 24-hour observation period); resulted in a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of these outcomes.|Within 24 hours of dosing|All participants were included in this analysis.||participants|||Number
138177|NCT00486863|Secondary|Number of Subjects With Reduction in S. Japonicum Egg Counts From Screening to 22 Weeks Gestation of Greater Than 90 Percent|Parasitologic response to treatment was evaluated by counting S. japonicum eggs per gram of stool at screening and again at 22 weeks gestation. Success of treatment was pre-specified as greater than 90 percent reduction in egg count from screening to 22 weeks gestation.|Screening and 22 weeks gestation|All participants for whom egg counts were reported are included in the analysis.||participants|||Number
138181|NCT00486863|Secondary|Median Maternal Hepcidin at 32 Weeks Gestation|Anemia of inflammation was assessed via maternal urine hepcidin levels. In response to inflammation, elevated serum levels of hepcidin is synthesized. Hepcidin causes sequestration of iron from bio-available forms to storage forms such as ferritin and decreases intestinal absorption of iron. Hepcidin was measured in participants' urine at 32 weeks gestation.|32 weeks gestation|All participants for whom hepcidin levels were reported are included in the analysis.||nanograms/milliliter||Inter-Quartile Range|Median
138182|NCT00486863|Secondary|Median Change in Maternal Transferrin Receptor:Ferritin Ratio From 14 to 32 Weeks Gestation|To assess total body iron, one needs to assess the storage compartment, which will contain sequestered iron, and the functional compartment, which represents bioavailable iron. Body iron status is defined by the two laboratory measurements that reflect these compartments, ferritin and serum transferrin receptor. The serum transferrin receptor:ferritin ratio has been shown in quantitative phlebotomy studies to provide an accurate assessment of total body iron over the entire range of status. At 14 and 32 weeks gestation, a blood sample was collected for assessment of total body iron by determination of the transferrin receptor:ferritin ratio. Each participant's change in ratio was calculated, and the median and interquartile range were determined for each group.|14 weeks and 32 weeks gestation|All participants for whom transferrin receptor:ferritin ratio was reported at both timepoints are included in the analysis.||ratio||Inter-Quartile Range|Median
138183|NCT00486863|Secondary|Mean Change in Maternal Hemoglobin From 14 to 32 Weeks Gestation|Hemoglobin concentration in a venous blood sample collected at 14 and 32 weeks gestation was measured using a multi-analyte analyzer. Each participant's change in hemoglobin concentration between the two timepoints was determined, and the mean and standard deviation for each group calculated.|14 weeks and 32 weeks gestation|All participants for whom hemoglobin concentrations were reported are included in the analysis.||grams/deciliter||Standard Deviation|Mean
138184|NCT00486863|Secondary|Number of Participants Whose Pregnancy Resulted in a Live Birth|Each participant was followed until delivery to record if the outcome of the pregnancy was a live birth. Live births were defined as the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, whether the umbilical cord had been cut or the placenta was attached.|At delivery|All participants for whom the status of the infant at delivery was reported are included in the analysis.||participants|||Number
138185|NCT00486863|Primary|Mean Newborn Birth Weight|Birth weight was collected for live infants at the time of delivery by a trained midwife, or within 24 hours of delivery for participants who chose to deliver at home with a helot, a birth attendant without formal training.|Within 24 hours of delivery.|All newborns for whom birth weights were reported were included in the analysis.||kilograms||Standard Deviation|Mean
138186|NCT00486837|Secondary|Change in Neutrophil Number in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 21 out of 28 subjects had applicable data to analyze. For Group 2, only 22 out of 28 subjects had applicable data to analyze.||percentage of change||Standard Deviation|Mean
138187|NCT00486837|Secondary|Change in Pseudomonas Load in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.||CFU/g||Standard Deviation|Mean
138188|NCT00486837|Secondary|Change in Total Bacterial Load in Induced Sputum From Baseline to Week 4||Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, all 28 subjects had applicable data to analyze.||CFU/g||Standard Deviation|Mean
138189|NCT00486837|Secondary|Change in Total Immunoglobulin G (IgG) Fragments in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 26 out of 28 subjects had applicable data to analyze.||ug/mL||Standard Deviation|Mean
138190|NCT00486837|Secondary|Change in Alpha-1-anti-trypsin (A1AT) Activity in Induced Sputum From Baseline at Week 4||Baseline vs Week 4|For Group 1, only 24 out of 28 subjects had applicable data to analyze. For Group 2, only 27 out of 28 subjects had applicable data to analyze.||ug/mL||Standard Deviation|Mean
138191|NCT00486837|Primary|Change in Free Elastase in Induced Sputum From Baseline to Week 4||Baseline vs Week 4|Modified Intent-to-Treat Population (mITT) was all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (free elastase in induced sputum) post baseline and at baseline (Visit 2).||ug/mL||Standard Deviation|Mean
138192|NCT00486811|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses are rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation."|Change from Baseline to Week 12 of the Maintenance Period|Safety Set||Units on a scale||Standard Deviation|Mean
138193|NCT00486811|Secondary|Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)|"The Sleep Questionnaire addressed the following question: Please rate the overall quality of your sleep last night? The quality of sleep at baseline and prior to completion of treatment are reported. The participant can choose one of the following options: Excellent, good, fair and poor."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number of participants reporting the appropriate sleep quality category are shown.||participants|||Number
138194|NCT00486811|Secondary|Sleep Questionnaire: Number of Awakenings During Sleep|"The Sleep Questionnaire addressed the following question: How many times did you wake up during the night?. Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep."|Week 12 of the maintenance period compared with baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF). The number reflects the number of participants that had the specified awakenings.||participants|||Number
145081|NCT00427635|Secondary|Change From Baseline in Number of Non Acidic Reflux Episodes|Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
138196|NCT00486811|Secondary|Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.|"The Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night(hours)?. The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement."|Week 12 of the maintenance period compared to baseline|Intention to treat (ITT). Last Observation Carried Forward (LOCF).||hours||Standard Deviation|Mean
138197|NCT00486811|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Comparison of Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).||Index value||Standard Error|Mean
138198|NCT00486811|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|Change From Baseline to Week 12 of the Maintenance Period|The number indicate the available responses. For certain categories, e.g. Physical Functioning only 318 participants in the tapentadol treatment were analyzed and in the General Health analysis only 328 oxycodone- and 336 placebo-treated participants were available. Intention to treat (ITT). Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Least Squares Mean
138199|NCT00486811|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint.|Baseline to week 12 of the maintenance period|Intention to treat (ITT) The results for median and interquartile ranges were not estimated as an insufficient number of participants discontinued due to lack of efficacy to estimate values.||days|||Number
138200|NCT00486811|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to week 12 of Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling.|Change from baseline to week 12 of the maintenance period|Intention to treat (ITT). No imputation performed.||units on a scale||Standard Deviation|Mean
138201|NCT00486811|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of 12 week maintenance period|Intention to treat (ITT). Last observation carried forward (LOCF). Assessments obtained more than one day after end of treatment were not included in the analysis.||participants|||Number
138202|NCT00486811|Secondary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"The twice daily pain assessments were averaged. The participants were to indicate their pain on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain intensity."|Change from Baseline to Week 12 of the Maintenance Period|Intention to treat (ITT). Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
138203|NCT00486811|Primary|Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS).|"For this twice daily pain assessment, the participants were required to indicate the level of pain experienced over the previous 12 hours on an 11-point Numeric Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain in the treatment group. Negative values indicate a reduction in pain."|Change from baseline over the 12 week Maintenance Period|Intent-to-treat (ITT), Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
138204|NCT00486759|Secondary|Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma|OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease.|At the end of treatment (Cycle 8, up to 12 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.||Percentage of patients|||Number
138205|NCT00486759|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.||Months||Inter-Quartile Range|Median
138236|NCT00486278|Secondary|Number of Subjects With Need for Additional Haemostatic Agents||within 24 hours after successful control of bleeding episode with trial product|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 9 subjects did not contribute to the data.||participants|||Number
140522|NCT00465088|Secondary|Percent Change in HDL-C From Baseline to Week 8|(Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 8|All treated subjects whose Week 8 value was obtained within the Week 8 visit window||percent change||95% Confidence Interval|Least Squares Mean
138206|NCT00486759|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion > 1.0 cm in the short axis during or at the end of therapy. (2) ≥ 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis < 1.0 cm must increase by ≥ 50% to a size of 1.5 x 1.5 cm or > 1.5 cm in the long axis. (3) ≥ 50 % increase in the greatest diameter of any previously identified node > 1.0 cm in its short axis or in the SPD of more than 1 node.|Baseline to end of the study (up to 4 years, 4 months)|Intent-to-treat population: All randomized patients, regardless whether or not they had actually received the assigned treatments.||Months||Inter-Quartile Range|Median
138207|NCT00486720|Primary|Safety and Tolerability as Assessed by the Number of Participants With Adverse Events.||Every 21 days while on therapy and at 30 days after the last dose of study therapy|||Participants|||Number
138208|NCT00486720|Primary|Number of Responders and Number of Non-responders Defined by International Working Group Response Criteria|Number of responders is defined as the number of patients in the analysis population who have complete response (CR), partial response (PR), or hematologic improvement (HI) per International Working Group Response Criteria during the course of the study. Confirmation of CR or PR will require a second assessment performed 4 weeks or more after the initial assessment. Confirmation of HI will require a second assessment performed 8 weeks or more after the initial assessment. Number of non-responders is defined as the number of patients who did not achieve CR, PR or HI in the study.|2 Years|Full analysis set (FAS) population is the analysis population. This population consists of all randomized patients who have received at least one dose of study medication.||Participants|||Number
138209|NCT00486525|Primary|CES-D|"The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||units on a scale||Standard Error|Least Squares Mean
138210|NCT00486525|Primary|Vitality, SF-36|"The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.~Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||units on a scale||Standard Error|Least Squares Mean
138211|NCT00486525|Primary|MFSI-SF Fatigue|"The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.~Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue."|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||units on a scale||Standard Error|Least Squares Mean
138212|NCT00486525|Primary|Stimulated ln (IL-1b)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||ln (pg/mL)||Standard Error|Least Squares Mean
138213|NCT00486525|Primary|Stimulated ln (IL-6)|log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||ln (pg/mL)||Standard Error|Least Squares Mean
138214|NCT00486525|Primary|Stimulated ln (TNF-a)|log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)|Immediately post-treatment and 3 months post-treatment|Any subjects who do not have any measurements post-baseline are excluded from analyses.||ln (pg/mL)||Standard Error|Least Squares Mean
138215|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less diffulty).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||Units on a scale||Inter-Quartile Range|Median
138216|NCT00486434|Primary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolut change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||Units on a scale||Inter-Quartile Range|Median
138217|NCT00486434|Secondary|Changes in Biochemical Markers of Bone & Cartilage Metabolism.Effect on Hand OA Assessed by X-ray & Questionnaire at Baseline and After 24 Months.Disease Progression in the Knee Evaluated by MRI.Nature and # of AEs Monitored Continuously During Study||January 2010||||||
138218|NCT00486434|Primary|Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criterias. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criterias were met. The outcome was meassured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.||mm||Standard Deviation|Mean
138219|NCT00486330|Primary|Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL)|Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.|10 days|||h*ng/mL||Full Range|Geometric Mean
138220|NCT00486291|Secondary|Absolute Weight Change (kg) From Baseline to Week 28||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||kg||Standard Error|Least Squares Mean
138221|NCT00486291|Primary|Change From Baseline in HbA1c at Week 28.||Baseline to 28 weeks|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)||percent change||Standard Error|Least Squares Mean
138222|NCT00486278|Secondary|Haematology: Platelet Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||10^9 cells/L||Standard Deviation|Mean
138223|NCT00486278|Secondary|Haematology: White Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||10^9 cells/L||Standard Deviation|Mean
138224|NCT00486278|Secondary|Haematology: Packed Cell Volume||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||percentage (%)||Standard Deviation|Mean
138225|NCT00486278|Secondary|Haematology: Red Cell Count||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||10^12 cells/L||Standard Deviation|Mean
138226|NCT00486278|Secondary|Haematology: Haemoglobin||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||g/dL||Standard Deviation|Mean
138227|NCT00486278|Secondary|Biochemistry: Creatinine||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||micromol/L||Standard Deviation|Mean
138228|NCT00486278|Secondary|Biochemistry: ALAT (Alanine Aminotransferase)||screening visit, pre-dose and 12 hours after dosing|Safety analysis set includes all subjects who received at least one dose of the investigational product.||U/L||Standard Deviation|Mean
138229|NCT00486278|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||participants|||Number
138230|NCT00486278|Secondary|Pharmakokinetic Parameters Based on FVIIa Activity: Vss (Distribution Volume at Steady State)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||mL/kg||Full Range|Median
138231|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: CL (Total Clearance)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||mL/h||Full Range|Median
138232|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: t½ (Terminal Half-life)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||hours||Standard Deviation|Mean
138233|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: MRT (Mean Residence Time)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||hours||Standard Deviation|Mean
138234|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC(0-inf) (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to Infinity)||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
138235|NCT00486278|Secondary|Pharmacokinetic Parameters Based on FVIIa Activity: AUC 0-t (Area Under the Plasma FVIIa Activity-time Curve From Time Zero to the Time (t) )||0-24 hours after trial product administration|All randomised patients in top 3 dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violating the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set. Some subjects did not contribute for pharmacokinetic analysis.||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
141802|NCT00454636|Secondary|Overall Survival (OS)|OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
138237|NCT00486278|Secondary|Cessation of Bleeding: Number of Doses Needed to Control Bleeding||Within 9 hours after first trial product administration or need of additional haemostatic medication within 9 hours after first trial administration additional haemostatic agents required to control bleed (treatment failure)|All randomised patients for whom at least one of the efficacy variables is assessed were to be included in the full analysis set (FAS). For the outcome measure 1 subject did not contribute to the data.||bleeding episodes|||Number
138238|NCT00486278|Secondary|Activated Partial Thromboplastin Time (aPTT)|The aPTT time measured in clinical samples reflects both the effect of the drugs (generation of thrombin and FXa) and the presence of rFVIIa /rFVIIa analogue in the plasma samples causing a dose dependent shortening of the clotting time.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||Sec||Standard Deviation|Mean
138239|NCT00486278|Secondary|F1 + 2 (Prothrombin Fragments 1+2)|Thrombin and F1+2 are formed in equimolar quantities by the enzymatic cleavage of prothrombin (FII), and F1+2 thus indicate that thrombin has been generated.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||pmol/L||Standard Deviation|Mean
138240|NCT00486278|Secondary|Prothrombin Time (PT)|The test measures the clotting time of plasma following the activation of tissue factor (TF also called thromboplastin) and calcium to hypocalcemic plasma. PT was provided in percent based on the measured PT in seconds and related/converted with the relevant standard curve. The percent value was derived based on the hyperbolic relation between PT (sec) and % PT activity.|pre-dose - 12 hours after trial product administration|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||percentage (%)||Standard Deviation|Mean
138241|NCT00486278|Secondary|Activated Recombinant Human Factor VII Analogue Activity in the Blood||0-24 hours after trial product administration|All randomised patients in top three dosing tiers 3, 4 and 5 who had pharmacokinetic assessments and completed the trial without violation of the protocol in a manner that was judged to affect the pharmacokinetic endpoints were included in the pharmacokinetic analysis set.||IU/mL||Standard Deviation|Mean
138242|NCT00486278|Primary|Number of Adverse Events (AEs)|Adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Monitoring of adverse events was performed from start of the trial to approximately 4 weeks after administration of trial product.|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.||events|||Number
138243|NCT00486265|Secondary|To Evaluate the Safety and Tolerability of AZD4877 on a Daily x 3 Schedule by Assessment of Adverse Events, Non-hematologic Labs and Vital Signs||Patients were followed for safety from the date of first dose of AZD4877 up to 30-days after the last administration of AZD4877, where possible.||||||
138244|NCT00486265|Secondary|To Assess the Effect of AZD4877 on Rate and Duration of CR, CRi, PR and Overall Response (CR,CRi, or PR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.||||||
138245|NCT00486265|Primary|To Determine the PK Profile of AZD4877 [ Time Frame: Daily x 3 Schedule ]|Maximum plasma concentration, Cmax|PK samples are collected on Days 1, 2, 3, 24 and 48 hours following the end of Day 3 AZD4877 infusion and Day 8.||||||
138246|NCT00486265|Primary|To Assess the Effect of AZD4877 on the Rate of Complete Remission (CR)|Marrow response is assessed by modified Cheson criteria for Acute Myelogenous Leukemia (AML). Possible outcomes for marrow response are CR (Complete Remission), CRi (Complete Remission with incomplete blood count recovery), PR (Partial Remission), and treatment failure.|Response is evaluated after a maximum of 2 courses of induction therapy.|8 of 9 patients in Part B were evaluable for response following a maximum of 2 courses of induction therapy.||Participants|||Number
138247|NCT00486265|Primary|To Identify a Maximum Tolerated Dose (MTD) of AZD4877 by Assessment of the Incidence of Dose-limiting Toxicities (DLTs)|To identify a maximum tolerated dose (MTD) of AZD4877 by assessment of the incidence of dose-limiting toxicities (DLTs)|Dose-limiting toxicities (DLTs) are evaluated during the first induction treatment course administered during the initial 15-day treatment period.||||||
138248|NCT00486252|Other Pre-specified|Change in Intraocular Presssure (IOP): Baseline to Month 1|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 1|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.||mmHg||Standard Deviation|Mean
138249|NCT00486252|Secondary|Categorized Percentage Change in Intraocular Pressure (IOP)|Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change < 0); Percentage reduction greater than 20% (percentage change < -20).|Month 1, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."||participants|||Number
138250|NCT00486252|Secondary|Percentage Change in Intraocular Pressure (IOP)|Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.|Month 1, Month 3|Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.||percentage change in mmHg||Standard Deviation|Mean
148576|NCT00399542|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
138251|NCT00486252|Primary|Change in Intraocular Pressure (IOP): Baseline to Month 3|Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.|Baseline, Month 3|"Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, & at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category."||mmHg||Standard Deviation|Mean
138252|NCT00486226|Secondary|Aneurysm Occlusion|Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)|post procedure to 6 months|no data was available for 21 subjects post-procedure and 26 subjects at 6 months follow-up; either because the investigator didn't submit the images or due to poor quality of the submitted images||participants|||Number
138253|NCT00486226|Secondary|Satisfactory Coil Mass Position|Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically|6 months|no data was available for 33 subjects; either because the investigator didn't submit the images or due to poor quality of the submitted images||participants|||Number
138254|NCT00486226|Secondary|Device or Procedure Related Adverse Events (AEs)|Incidence of device or procedure related adverse events during the index procedure and till discharge|index procedure to discharge; an average of 3.8 days|||participants|||Number
138255|NCT00486226|Primary|The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)|"Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency.~Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically"|Start of the procedure to end of the procedure (defined as removal of catheter sheath introducer after the coiling procedure)|||participants||95% Confidence Interval|Number
138256|NCT00486044|Secondary|Changes in Cognitive Performance|"Change in Hopkins Verbal Learning Test Delayed Recall~The Hopkins Verbal Learning Test Delayed Recall score is the raw number of words recalled at Trial 4, adjusted for years of education and age. This is a 12-item word list test."|Baseline and 9 months|1 participant in simvastatin arm with missing data||adjusted words recalled||Standard Deviation|Mean
138257|NCT00486044|Secondary|Change in Inflammatory Markers|Change noted in serum high-sensitivity c-reactive protein|baseline and 9 months|2 participants in the simvastatin arm and 3 participants in the placebo arm had incomplete hs-CRP results||mg/L||Standard Deviation|Mean
138258|NCT00486044|Secondary|Changes in Regional Cerebral Blood Flow on MRI|Mean changes noted in posterior cingulate cortex|baseline and 9 months|Number of participants analyzed represent participants in MRI substudy with readable MRI scans at both baseline and 9 months; 24 and 17 readable MRI scans in simvastatin and placebo arms, respectively. Unusable MRI scans resulted from poor quality images due to technical problems.||mL/100 g/min||Standard Deviation|Mean
138259|NCT00486044|Primary|Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42||baseline and 9 months|1 participant declined follow up CSF collection in simvastatin arm; CSF could not be accessed at month 9 in 1 participant in placebo arm||ng/L||Standard Deviation|Mean
138260|NCT00486018|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI-VFQ-25 subscale||Standard Deviation|Mean
138261|NCT00486018|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
138262|NCT00486018|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||μm||Standard Deviation|Mean
138263|NCT00486018|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
138264|NCT00486018|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost <15 letters will be greater than the percentage of subjects who “gained >=15 letters” as “losing <15 letters” includes both those who gained >=15 letters and those who were “stable” (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
138265|NCT00486018|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
138284|NCT00485732|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.||subjects|||Number
138266|NCT00486018|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.||Units on a scale||Standard Deviation|Mean
138267|NCT00485953|Secondary|Markers of Bone Resorption and Bone Formation||at 24 months||||||
138268|NCT00485953|Secondary|BMD by DXA at the Femoral Neck and Hip||at 24 months||||||
138269|NCT00485953|Primary|BMD of Spine by DXA|BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.|at 24 months|||percentage change||Standard Error|Mean
138270|NCT00485836|Secondary|Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
138271|NCT00485836|Secondary|Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6|The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.|Baseline and 6 months|Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.||Points on the NEI VFQ-25 subscale||Standard Deviation|Mean
138272|NCT00485836|Secondary|Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6|A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||μm||Standard Deviation|Mean
138273|NCT00485836|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6|A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.|6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
138274|NCT00485836|Secondary|Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
138275|NCT00485836|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline|BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the LOCF method.||Percentage of participants||95% Confidence Interval|Number
138276|NCT00485836|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months|BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.|Baseline and 6 months|Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.||Units on a scale||Standard Deviation|Mean
138277|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo|after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Median
138278|NCT00485758|Secondary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
138279|NCT00485758|Primary|Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo|After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo|Baseline and 12 Weeks|Full Analysis Set||Percent change at Wk 12 compared to Bl||95% Confidence Interval|Least Squares Mean
138280|NCT00485732|Secondary|Number of Subjects With Pregnancies and Their Outcome|Total: the total number of pregnancies in a group. The specific outcomes are also listed.|from Day 0 up to Month 7|Analysis was performed on subjects with a pregnancy.||subjects|||Number
138281|NCT00485732|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7|||subjects|||Number
138282|NCT00485732|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.|From Day 0 up to Month 7|||subjects|||Number
138283|NCT00485732|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day (Days 0-29) period following each vaccination|||subjects|||Number
146852|NCT00413153|Secondary|Lipid Metabolism - Serum Triglyceride|6 month mean and standard deviation for serum triglyceride.|6 months|Repeated measures analysis using all available data points for each participant||mg/dL||Standard Deviation|Mean
138287|NCT00485732|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies."|One month post Dose 3 (Month 7)|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
138288|NCT00485693|Secondary|Number of Participants With Adverse Events or Serious Adverse Events Through 30 Days||Up to 30 days||||||
138289|NCT00485693|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4|The subject’s pain intensity was to be assessed with activity (NRS-A) after actively flexing the involved knee to the maximum flexion point possible. The subject was asked to respond to the following question: “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?”|0 to 96 hours|||Units on a scale*hours||Standard Deviation|Mean
138290|NCT00485485|Primary|Participant Response Rate|Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.|At 6 weeks reconfirmed 6 weeks later|||Participants|||Number
138291|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).|Total Mood Disturbance score sums up over the domain scores regarding Tension-anxiety, Depression-ejection, Anger-hostility, Vigor-activity (was subtracted), Fatigue-inertia, Confusion-bewilderment. Domain scores were derived as sum of the respective items and range from 0 to 20. With exception of Vigor-activity high values describe bad mood.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.||Unit on a scale||Standard Deviation|Mean
138292|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject’s Sleep.|Pain interference with sleep refers to patient's last evening prior to the visit and was assessed using a 100mm visual analog scale (VAS). The VAS ranges from 0 (did not interfere) to 100 (completely interfered).|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing values were included.||Unit on a scale||Standard Deviation|Mean
138293|NCT00485472|Secondary|Amount of Rescue Medication Use During 8 Week Maintenance Period.|Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day.|during 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects who entered the Maintenance Phase were included.||tablets/day||Standard Deviation|Mean
138294|NCT00485472|Secondary|Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).|Improvement = reduction of >= 20% and >= 10 mm in both WOMAC pain and physical function subscale. Those who met the criteria in either of the subscales had improved if response to Patient's Global Impression of change from baseline was at least 'mildly improved'. High improvement = reduction of >= 50% and >= 20 mm in either of the subscales. Response = either high improvement or improvement.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Dropouts due to lack of efficay were defined as non-responders. For dropouts due to any other reason LOCF was applied to the underlying WOMAC subscale scores.||participants|||Number
138295|NCT00485472|Secondary|Patient’s Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.|Patient's global impression of change from baseline is a score that ranges from 'very much worse' to 'very much improved'.|at the end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Only subjects with non-missing measurements of Patient's global impression of change from baseline were included.||Participants|||Number
138296|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.|The WOMAC total score is the sum of the normalized subscale scores for pain, stiffness, and physical function and ranges from 0 to 300, high values describe high grade of impact.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
138297|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.|The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
138298|NCT00485472|Secondary|Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.|The WOMAC physical function subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of difficulty in performing daily activities.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. LOCF imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
138379|NCT00484419|Secondary|Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16|mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
138299|NCT00485472|Primary|Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period|The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.|Baseline, end of 8 week Maintenance Period|Full Analysis Set (FAS), defined as all randomized subjects that have received at least one dose of trial medication and had at least one post-baseline WOMAC assessment. Last observation carried forward (LOCF) imputation method was applied in case of missing WOMAC assessment.||Unit on a scale||Standard Deviation|Mean
138300|NCT00485433|Secondary|Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days||Up to 30 days||||||
138301|NCT00485433|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours|The subject’s pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?”|0 to 72 hours|||Units on a scale*hours||Standard Deviation|Mean
138302|NCT00485303|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||percentage of participants|||Number
138303|NCT00485303|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. 'N' (number of participants analyzed) = participants who were evaluable for this measure.||participants|||Number
138304|NCT00485303|Secondary|Time to Radiographic Progression|Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
138305|NCT00485303|Secondary|Time to PSA Progression|The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.|Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
138306|NCT00485303|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least 1 dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. “N” (number of participants analyzed) =participants who were evaluable for this measure.||percentage of participants|||Number
138307|NCT00485303|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Every 3 months until death or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
138308|NCT00485303|Secondary|Radiographic Progression Free Survival (PFS)|The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months|||days||95% Confidence Interval|Median
138320|NCT00485264|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||hour*mg/L||Standard Deviation|Mean
138309|NCT00485303|Secondary|Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)|The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.|Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||days||95% Confidence Interval|Median
138310|NCT00485303|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Day 1 of each cycle (of 28 days each) up to Cycle 12|Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.||percentage of participants||95% Confidence Interval|Number
138311|NCT00485264|Secondary|Change of CD4 Percent From Baseline||Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of total lymphocytes||95% Confidence Interval|Mean
138312|NCT00485264|Secondary|Change of CD4 Count (Cells/µL) From Baseline||Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||cells/µL||95% Confidence Interval|Mean
138313|NCT00485264|Secondary|Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL|Plasma HIV RNA (RNA) concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular).|Baseline, Week 24, 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of participants||95% Confidence Interval|Number
138314|NCT00485264|Secondary|Number of Participants Who Died||From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
138315|NCT00485264|Secondary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
138316|NCT00485264|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 48|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of participants||95% Confidence Interval|Number
138317|NCT00485264|Primary|PK Parameter: Concentration at 12 Hours Postdose (C12h)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Plasma concentration at 12 hours postdose (C12h) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||ng/mL||Standard Deviation|Mean
138318|NCT00485264|Primary|PK Parameter: Time to Half of Maximum Plasma Concentration Cmax (T1/2)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Time to half of maximum plasma concentration Cmax (T1/2) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||hour||Standard Deviation|Mean
138319|NCT00485264|Primary|PK Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Maximum plasma concentration (Cmax) was taken directly from the observed concentration-time data.|Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.|Participants with intensive pharmacokinetic (PK) results at the final recommended dose (Stage I). Cohorts IV and V were not included in this interim analysis.||ng/mL||Standard Deviation|Mean
138322|NCT00485264|Primary|Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication|The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||participants|||Number
138323|NCT00485264|Primary|Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry through Week 24|Final Dose Population: Participants accrued into Stage I and treated only at the dose ultimately selected for their cohorts are combined with those accrued into Stage II, where all participants received only the final selected doses for their respective cohorts.||percentage of participants||95% Confidence Interval|Number
138324|NCT00485173|Other Pre-specified|Ossification in the Region of Target Level|Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.|24 months post-operation|Primary dataset.||percentage of participants|||Number
138325|NCT00485173|Secondary|Number of Patients Who Had Secondary Surgeries at the Index Level|Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.|24 months post-operation|||participants|||Number
138326|NCT00485173|Secondary|Hospital Stay||During the time of hospital stay, average of 1 day.|Primary dataset.||days||Standard Deviation|Mean
138327|NCT00485173|Secondary|Blood Loss||During the time of operation, approximately 1.5 hours.|Primary dataset.||ml||Standard Deviation|Mean
138328|NCT00485173|Secondary|Operative Time|Operative time was recorded from skin incision to wound closure.|Time of operation, approximately 1.5 hrs.|Primary dataset.||hrs||Standard Deviation|Mean
138329|NCT00485173|Secondary|Success Rate of SF-36 MCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
138330|NCT00485173|Secondary|Success Rate of SF-36 PCS|Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
138331|NCT00485173|Other Pre-specified|General Health Status -- SF-36 MCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
138332|NCT00485173|Secondary|Arm Pain Success Rate|Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
138333|NCT00485173|Other Pre-specified|General Health Status -- SF-36 PCS|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
138334|NCT00485173|Secondary|Neck Pain Success Rate|Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.|24 months post-operation|Primary dataset.||percentage of participants|||Number
138335|NCT00485173|Other Pre-specified|Arm Pain Score|"Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score will be the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
138336|NCT00485173|Secondary|Success Rate of Neurological Status|Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.|24 months post-operation|Primary dataset.||percentage of participants|||Number
138337|NCT00485173|Other Pre-specified|Neck Pain Score|"Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score is the sum of pain intensity and frequency scores."|24 months post-operation|Primary dataset.||units on a scale||Standard Deviation|Mean
138338|NCT00485173|Secondary|Success Rate of Neck Disability Index|Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.|24 months post-operation|Primary dataset.||percentage of participants|||Number
138340|NCT00485173|Secondary|Success Rate of Fusion|"Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:~Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.~No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.~No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs)."|24 months post-operation|Primary dataset.||percentage of participants|||Number
138341|NCT00485173|Primary|Rate of Overall Success|"Rate of overall success is reported as the percentage of participants who met all of the following criteria:~fusion at the treated level;~pain/disability (Neck Disability Index) success;~neurological status success;~no serious adverse event classified as “implant associated” or “implant/surgical procedure associated;”~no additional surgical procedure classified as a “failure.”"|24 months post-operation|Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)||percentage of participants|||Number
138342|NCT00485069|Secondary|"Mean Change From Baseline in Awake Time Off (Hours) and Awake Time On (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With 0 Off (Hour) at Baseline"|"Off state is where PD symptoms are not adequately controlled by the drug. On state is where PD symptoms are well controlled by the drug. The off’s duration (awake time spent off) and the on’s duration (awake time spent on) on each day were calculated."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants having off hour of zero at baseline were not included at FAP. These participants as well as those prematurely withdrawn from the study were not included at Week 52."||hours||Standard Deviation|Mean
138343|NCT00485069|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP|"CGI is measured on the following 7-point scale: 1, Very much improved; 2, Much Improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; and 7, Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Week 52 and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||participants|||Number
138344|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-419|FAS||percentage of participants|||Number
138345|NCT00485069|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 52) was the event, and participants who had completed the study were censored.|Days 0-422|FAS||percentage of participants|||Number
138346|NCT00485069|Secondary|Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||percent change||Standard Deviation|Mean
138347|NCT00485069|Secondary|"Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|The Schwab and England Activities of Daily Living Scale Score is measured as percentage, from 100% (Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal. Unaware of any difficulty) to 0% (Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden).|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline in off state, or having no data in the corresponding state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."||percent change||Standard Deviation|Mean
138348|NCT00485069|Secondary|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided.|Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||participants|||Number
138349|NCT00485069|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. LOCF was used for the FAP data to impute post-baseline missing values. Some participants in each state were not included at FAP as having no post-baseline data in the corresponding state or having no data in the corresponding state at Week 52/withdrawal.|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."||participants|||Number
138440|NCT00484094|Secondary|Percentage of Participants With Survived Graft|Graft survival was defined as not showing graft loss at the time of evaluation.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.||Percentage of participants||95% Confidence Interval|Number
138350|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn from the study were not included at Week 52.||percent change in score||Standard Deviation|Mean
138351|NCT00485069|Secondary|Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
138352|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 in that group and those prematurely withdrawn in each group were not included at Week 52."||percent change in score||Standard Deviation|Mean
138353|NCT00485069|Secondary|"Japanese UPDRS Part III Mean Total Score (in On State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP"|"The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants having off state at baseline were not included in the ROP+L-dopa group at baseline. The participant not included in the FAP as well as one having off state in the ROP+L-dopa group at Week 52 and those prematurely withdrawn in each group were not included at Week 52."||units on a scale||Standard Deviation|Mean
138354|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change. These participants as well as those prematurely withdrawn were not included at Week 52||percent change in score||Standard Deviation|Mean
138355|NCT00485069|Secondary|"Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for FAP data. Some participants were not included at FAP as having a baseline value of zero, having no post-baseline data in on state, not having off state at baseline in off state, or having no data at Week 52/withdrawal in off state. These participants as well as those prematurely withdrawn were not included at Week 52."||percent change in score||Standard Deviation|Mean
138356|NCT00485069|Secondary|Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||units on a scale||Standard Deviation|Mean
138357|NCT00485069|Secondary|"Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug. LOCF was used for the FAP data. Some participants were not included at FAP as having no post-baseline data in on state or having no data in off state at Week 52/withdrawal."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. Participants without off state at baseline were not included in the analysis of baseline off state data. Participants not included at FAP as well as those prematurely withdrawn from the study were not included at Week 52."||units on a scale||Standard Deviation|Mean
138358|NCT00485069|Secondary|Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Percent change from baseline was calculated as (change from baseline score/baseline score) * 100; change from baseline was calculated as thescore at the observation day minus the baseline score.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having a baseline value of zero, which could not be used for calculating the percent change, or having no post-baseline data. These participants as well as those prematurely withdrawn in each group were not included at Week 52.||percent change in score||Standard Deviation|Mean
138359|NCT00485069|Secondary|Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
138360|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
138361|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group|The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. Participants prematurely withdrawn from the study were not included at Week 52.||units on a scale||Standard Deviation|Mean
138362|NCT00485069|Secondary|"Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by On/Off State in the ROP+L-Dopa Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Off state is where PD symptoms are not adequately controlled by the drug."|Baseline, Week 52, and FAP (up to Week 52)|"FAS. LOCF was used for the FAP data to impute post-baseline missing values. Some participants were not included at FAP as having no post-baseline data in on state, not having off state at baseline, or no data in off state at Week 52/withdrawal. These participants as well as those prematurely withdrawn were not included at Week 52."||units on a scale||Standard Deviation|Mean
138363|NCT00485069|Secondary|Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline, Week 52, and FAP (up to Week 52)|FAS. LOCF was used for the FAP data to impute post-baseline missing values. One participant was not included in the ROP+L-dopa group at FAP as having no post-baseline data. This participant as well as those prematurely withdrawn from the study in each group was not included at Week 52.||units on a scale||Standard Deviation|Mean
138364|NCT00485069|Primary|"Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in On State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)"|"The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. On state is where PD symptoms are well controlled by the drug. Participants with off state at baseline or without post-baseline data were not included in the ROP+L-dopa group at FAP. These participants as well as one with off state at Week 52 and those prematurely withdrawn were not included at Week 52."|Baseline, Week 52, and FAP (up to Week 52)|Full Analysis Set (FAS): all participants enrolled in the Treatment Phase, excluding those with objective measurements not meeting the major eligibility criteria, who did not receive ROP at all, and those with no valid post-baseline data. Last observation carried forward (LOCF) was used for the FAP data to impute post-baseline missing values.||units on a scale||Standard Deviation|Mean
138365|NCT00484939|Secondary|AEs, Laboratory Parameters, Vital Signs||Throughout study||||||
138366|NCT00484939|Secondary|Duration of Follow-up|Duration of follow-up is defined as the time in days from randomization until disease progression or death, or time to censoring for overall survival.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Days||Standard Deviation|Mean
138367|NCT00484939|Secondary|Percentage of Participants Requiring Additional Treatment for Malignancy|Reported is the percentage of participants requiring additional treatment for malignancy in the survival follow-up period.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Percentage of participants|||Number
138378|NCT00484419|Secondary|Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean|change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
138368|NCT00484939|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status is a scale used to quantify cancer patients' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death. Reported is the percentage of participants in each of the 6 ECOG performance status categories.|Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).|Intent-to-treat population: All participants randomized into the study.||Percentage of participants|||Number
138369|NCT00484939|Secondary|Overall Survival|Overall survival was defined as the time in months from randomization to death from any cause.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Months||95% Confidence Interval|Median
138370|NCT00484939|Secondary|Time to Response|Time to response was defined as the time in months from the date of first study treatment to the date of the first documentation of complete response (CR) or partial response (PR), whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. Participants who did not have a confirmed response were censored at the date of the last evaluable tumor assessment, or if that was unavailable, at the date of the first dose of study medication.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Months||95% Confidence Interval|Median
138371|NCT00484939|Secondary|Duration of Response|Duration of response was defined as the time in months from the first confirmed complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurred first. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a complete response or partial response were included in the analysis.||Months||95% Confidence Interval|Median
138372|NCT00484939|Secondary|Best Overall Response (BOR)|BOR was defined as the best response (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], not evaluable [NE], or not assessed [NA]) recorded from the start of study treatment until disease progression (PD) or death. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study. Only participants with a response were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
138373|NCT00484939|Primary|Progression-free Survival|Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of the study (up to 5 years 8 months)|Intent-to-treat population: All participants randomized into the study.||Months||95% Confidence Interval|Median
138374|NCT00484679|Primary|Mean Change in Cortisol Levels From Baseline to Week 24|Mean change in cortisol levels from baseline to week 24 after four triamcinolone acetonide 10 ml injections 6 weeks apart.|baseline, week 24|Participants who completed all treatment and follow-up visits||mg/dL||Standard Deviation|Mean
138375|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)|percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change in LDL-C||95% Confidence Interval|Least Squares Mean
138376|NCT00484419|Secondary|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16|mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change in LDL-C||Standard Deviation|Mean
138377|NCT00484419|Secondary|Mean Change in LDL-C From Week 0(Baseline) to Week 16|mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
138441|NCT00484094|Secondary|Percentage of Participants Alive|The investigator recorded the participant’s survival status and evaluation date on the CRF.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set; Participants who had available data.||Percentage of participants||95% Confidence Interval|Number
138380|NCT00484419|Secondary|Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16|mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
138381|NCT00484419|Secondary|Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean|change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
138382|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16|mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||Standard Deviation|Mean
138383|NCT00484419|Secondary|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8|mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||Standard Deviation|Mean
138384|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||95% Confidence Interval|Least Squares Mean
138385|NCT00484419|Secondary|Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean|change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||uIU/mL||95% Confidence Interval|Least Squares Mean
138386|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 16|change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||Standard Deviation|Mean
138387|NCT00484419|Secondary|Mean Change in FPG From Week 0(Baseline) to Week 8|mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|||mg/dL||Standard Deviation|Mean
138388|NCT00484419|Secondary|Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean|change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
138389|NCT00484419|Secondary|Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean|change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.|8 weeks change = week 8- week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
138390|NCT00484419|Primary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint|Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change HbA1c||Standard Deviation|Mean
138391|NCT00484419|Secondary|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8|change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.|8 weeks change = week 8- week 0.|||% change in HbA1c||Standard Deviation|Mean
138392|NCT00484419|Secondary|Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean|Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.|16 weeks change = week 16 - week 0.|The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.||% change in HbA1c||95% Confidence Interval|Least Squares Mean
138393|NCT00484393|Primary|To Determine if a Difference in Pain Scale Ratings is Detectable Following Intramuscular Palivizumab Injection That Was Pre-treated With Placebo or Tetracaine.|Parent score 1-10 (1 representing no pain and 10 representing extreme pain) FLACC (Face, Legs, Activity, Cry, Consolability) Score 0-10 (at baseline and post injection) (0 representing no pain and 10 representing extreme pain) Change in FLACC score|2 visits, 1 month apart|Each participant was evaluated for repsonse following tetracaine and following placebo||units on a scale||Full Range|Mean
138394|NCT00484315|Secondary|In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure|The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment (“in-segment”) is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.|9 months post-index procedure|All patients from the per protocol analysis set who were randomized to the angiographic subset and completed their angiographic follow-up were analyzed for the secondary endpoint.||percent diameter stenosis||Standard Deviation|Mean
139143|NCT00476008|Secondary|Trail Making Test - Part B|This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning.|baseline and 12 months|||seconds||Standard Deviation|Mean
138395|NCT00484315|Primary|Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.|The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.|12 months post-index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per protocol analysis set. All randomized participants who had the randomly assigned study stent implanted in the target coronary artery are included.||participants|||Number
138396|NCT00484289|Primary|Number of Participants With Vital Signs, Physical Examinations, and Electrocardiogram Findings That Were Considered to be AEs by the Investigator||At week 0, 2, 4; then once every 4 weeks up to 48 months; then once in every 3 months or 12 weeks to end of study (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.||participants|||Number
138397|NCT00484289|Secondary|Abatacept PK Parameter: Minimum Plasma Concentration at Steady State|Minimum Plasma Concentration (Cmin) is the minimum observed serum drug concentration at steady state.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||µg/mL||Full Range|Median
138398|NCT00484289|Secondary|Abatacept PK Parameter: Maximum Serum Concentration at Steady State|Maximum plasma concentration is the maximum observed serum drug concentration at steady state (Css max).|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||µg/mL||Full Range|Median
138399|NCT00484289|Secondary|Abatacept PK Parameter: Area Under the Serum Concentration-time Curve at Steady State|Area under the plasma concentration-time curve (AUCss) at steady state for each dosing interval was determined using the linear trapezoidal rule.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||µg*h/mL||Full Range|Median
138400|NCT00484289|Secondary|Abatacept PK Parameter: Total Body Clearance|Total body clearance is the rate and extent at which the drug is eliminated from the body. The clearance of a drug is used to understand the processes involved in drug elimination, distribution and metabolism.|Samples were collected predose at week 8, 12, 16, 24; end of infusion at week 12; and at week 13-15 visits.|All participants who received abatacept and had blood samples for assay.||L/day||Full Range|Median
138401|NCT00484289|Secondary|Number of Participants Who Were Positive for Anti-abatacept and Anti-CTLA4-T Antibodies|Validated enzyme-linked immunoassay (ELISA) method was used to measure anti-abatacept and anti-CTLA4-T antibody levels. For anti-abatacept antibody ELISA, a sample was considered seropositive if it had a titer of 400 or greater and if immunodepletion was observed. The responses that were negative in initial screen were reported as seronegative with a value of < 400. A sample was considered positive in CTLA4-T antibody ELISA if it had a titer of 25 or greater and if immunodepletion was observed.|At BL (week 0), weeks 24, 48, 72, 96, 120, 144, 168, and 192.|All participants who received study treatment, and had BL and at least one PBL measurement for immunogenicity.||participants|||Number
138402|NCT00484289|Secondary|Change From Baseline in Rheumatoid Factor Levels at Weeks 24, 48, 96, 144, and 192|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please refer to outcome 19 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||IU/mL||95% Confidence Interval|Mean
138403|NCT00484289|Secondary|Baseline and Postbaseline Rheumatoid Factor Levels|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. RF levels are considered positive if value is >20 and considered negative if value is <20. Please see outcome 20 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||IU/mL||Standard Deviation|Mean
138404|NCT00484289|Secondary|Percentage Decrease in C-reactive Protein Levels From Baseline at Weeks 24, 48, 96, 144, and 192|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease, negative values indicate improvement. Percentage improvement from BL = (BL - PBL value) / BL value * 100. Please refer to outcome 17 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||percentage improvement||95% Confidence Interval|Mean
138405|NCT00484289|Secondary|Baseline and Postbaseline C-reactive Protein (CRP) Levels|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and is a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Please see outcome 18 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants with both BL and PBL measurement at a given point time point.||mg/dL||Standard Deviation|Mean
138415|NCT00484289|Secondary|Change From Baseline in DAS 28 Scores at Week 24, 48, 96, 144, and 192|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Please refer to outcome 7 for BL and PBL values.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||Units on a Scale||95% Confidence Interval|Mean
138406|NCT00484289|Secondary|Change From Baseline in Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 15 for BL and PBL values.|At BL (Week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||95% Confidence Interval|Mean
138407|NCT00484289|Secondary|Baseline and Postbaseline Mental Component Summary (MCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||Standard Deviation|Mean
138408|NCT00484289|Secondary|Change From Baseline in Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Score at Weeks 24, 48, 96, 144, and 192|The SF-36 covers 8 health dimensions including 4 physical (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful. Please see outcome 13 for BL and PBL values.|At baseline (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||95% Confidence Interval|Mean
138409|NCT00484289|Secondary|Baseline and Postbaseline Physical Component Summary (PCS) of Health-Related Quality of Life (SF-36) Scores|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role functioning [physical], bodily pain, and general health) and 4 mental subscales (vitality, social function, role emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Please see outcome 14 for change from BL data.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given point time point.||Units on a Scale||Standard Deviation|Mean
138410|NCT00484289|Secondary|Percentage of Participants Who Achieved a Reduction of At Least 0.3 Units From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 96, 144, 192|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from BL in HAQ.|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||percentage of participants||95% Confidence Interval|Number
138411|NCT00484289|Secondary|Number of Participants in Remission (DAS 28 Score < 2.6) at Weeks 24, 48, 96, 144, 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.~Participants with DAS 28 score < 2.6 were considered to be in remission."|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.||participants|||Number
138412|NCT00484289|Secondary|Number of Participants With Low Disease Activity Score (DAS 28 Score ≤ 3.2) at Weeks 24, 48, 96, 144, 192|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale. Participants with DAS 28 score ≤ 3.2 were considered to have low disease activity.|At weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with available scores at the given time point.||participants|||Number
138413|NCT00484289|Primary|Number of Participants With Abnormal Laboratory Changes (ALC)|The laboratory tests were analyses included enzyme, gastrointestinal, hematology, hepatobiliary, lipid, metabolic, nutritional, blood gas, microbiology, serology, protein, chemistry, renal, urinary tract, urinalyses, water, electrolyte and mineral investigations.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.||participants|||Number
138414|NCT00484289|Secondary|Number of Participants With DAS 28 Score Change ≥ 1.2 From Baseline at Weeks 24, 48, 96, 144, and 192|"The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale.~Participants with DAS 28 score change ≥ 1.2 from BL were considered to have improvement."|At BL (week 0), weeks 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||participants|||Number
146853|NCT00413153|Secondary|Fasting Glucose|6 month mean and standard deviation for fasting glucose.|6 months|Repeated measures analysis using all available data points for each participant||mg/dL||Standard Deviation|Mean
138416|NCT00484289|Secondary|Baseline (BL) and Postbaseline (PBL) Disease Activity Scores (DAS 28)|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, CRP levels, and participant assessment of disease activity measure on a visual analogue scale of 100 mm. The DAS28 has numeric thresholds that define high disease activity (change of > 5.1), low disease activity (change of ≤ 3.2) and remission (< 2.6). Please see outcome 8 for change from BL data.|At BL (week 0), week 24, 48, 96, 144, and 192.|All treated participants who received at least 1 dose of the study drug. n = participants with both BL and PBL measurement at a given time point.||Units on a Scale||Standard Deviation|Mean
138417|NCT00484289|Secondary|Percentage of Participants With ACR 70 Response Over Time|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.||percentage of participants||95% Confidence Interval|Number
138418|NCT00484289|Secondary|Percentage of Participants With ACR 50 Response Over Time|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = Number of participants assessed at given time point.||percentage of participants||95% Confidence Interval|Number
138419|NCT00484289|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response Over Time|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant global assessment of pain, C-reactive protein, and degree of disability in Health Assessment Questionnaire score.|At weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192.|All treated participants who received at least 1 dose of the study drug. n = number of participants assessed at given time point.||percentage of participants||95% Confidence Interval|Number
138420|NCT00484289|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. Both subjective and objective AEs and SAEs are included.|From initiation of the study drug (31 Mar 2008) to data cutoff (27 Dec 2010). The overall mean duration of exposure to the study drug was approximately 3 years (34.3 ± 10.7 months).|All treated participants who received at least 1 dose of the study drug.||participants|||Number
138421|NCT00484185|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who discontinued the study due to AEs was reported.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
138422|NCT00484185|Other Pre-specified|Duration of Adverse Events (AEs)|Total time from onset of adverse event till the event is resolved. Duration of AE per event = AE stop date minus AE start date plus 1.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
138423|NCT00484185|Secondary|Percentage of Participants With Efficacy Evaluation|The efficacy of study drug was rated as ‘very effective’, ‘effective’, ‘slightly ineffective’ and ‘ineffective’.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||percentage of participants|||Number
138424|NCT00484185|Secondary|Total Infusion of Study Medication|Total dose of study drug infused was calculated over the study duration.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once.||IU||Standard Deviation|Mean
138425|NCT00484185|Secondary|Average Infusion Dose of Study Medication|Average of dose per infusion per kilogram (kg) body weight was reported for prophylaxis purpose or on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed)= participants evaluable for this measure and 'n' = participants evaluable for the specified category.||international unit/kilogram (IU/kg)||Standard Deviation|Mean
138426|NCT00484185|Secondary|Mean Number of Breakthrough Bleeds Within 48 Hours of Study Medication|Mean frequency of breakthrough (spontaneous/non-traumatic) bleeds of each participant within 48 hours of a preventive/prophylaxis dose of BeneFIX was calculated from number of irregular bleeding which occurred in each participant. Mean frequency breakthrough bleeds for total participants within 48 hours of a preventive/prophylaxis dose of BeneFIX was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||breakthrough bleeds||Standard Deviation|Mean
138437|NCT00484159|Secondary|Successful Treatment|Greater or equal to 50% pain relief plus procedural satisfaction lasting at least 3 months. What is being measured is the number of participants with a positive outcome.|3-months postprocedure|||participants|||Number
138427|NCT00484185|Secondary|Mean Number of Infusion of Study Medication|Mean frequency of BeneFIX administration of each participant was calculated from number of BeneFIX infusions which each participant received for treatment of each new bleed. Mean frequency of BeneFIX administration for total participants was summarized.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||infusions||Standard Deviation|Mean
138428|NCT00484185|Secondary|Number of Responses to On-demand Treatment With Study Medication|Responses to on-demand treatment were rated by participant/caregiver or physician each time the drug was administered, on 4-point scale. Score 1=excellent (definite pain relief [PR] and improvement [imp] within 8 hours [h] of infusion [inf], no additional inf); score 2=good (definite PR and imp within 8h of inf, at least 1 additional inf for complete resolution [CR] of bleeding or starting after 8h of inf, no additional inf); score 3=moderate (probable or slight imp starting after 8h of inf, at least 1 additional inf for CR of bleeding); score 4=no imp at all, or condition worsens).|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||responses|||Number
138429|NCT00484185|Secondary|Mean Annualized Bleeding Rate (ABR)|An annualized bleeding rate (ABR) was calculated as the number of bleeds requiring administration of BeneFIX (for on-demand therapy and surgery), divided by total period of bleeding multiplied by 365.25. Total period of bleeding is the number of days on treatment for prophylaxis purpose and on-demand therapy and surgery.|Baseline up to 6 months|Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||bleeds per year||Standard Deviation|Mean
138430|NCT00484185|Primary|Number of Participants With Unexpected Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Unexpected AEs were those that were not included in precaution of local product document.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
138431|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) by Relationship|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. All causalities and drug-related AEs reported. Drug-related AEs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
138432|NCT00484185|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed based on response to a question ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no-resolved'.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
138433|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Seriousness|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
138434|NCT00484185|Primary|Number of Participants With Action Taken in Response to Adverse Events (AEs)|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. After an onset of an AE, relevant actions were undertaken on the study drug or the participant. Actions related to study drug included: dosage reduced, dosage increased, stopped temporarily or permanently, no action taken; actions related to participants included: withdrawal from the study, concomitant medication, no action taken or any other as per physician’s discretion.|Baseline up to 6 months|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.|||||
138435|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. Same participant may be represented in more than 1 category.||participants|||Number
138436|NCT00484185|Primary|Number of Participants With Adverse Events (AEs) According to Baseline Characteristics|AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AE assessed by baseline characteristics (chr) included age, gender, pediatric/geriatric status, liver disorder, BeneFIX treatment (previously/newly), factor nine (FIX) gene mutation, prior exposure to plasma-derived FIX products, prior FIX regimen(s) utilized, personal history of FIX inhibitor, family history of hemophilia B, severity of bleeding, medical history, concomitant medication and therapy.|Baseline up to 6 months|Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs.||participants|||Number
138442|NCT00484094|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection Using Banff 09 Diagnostic Categories for Renal Allograft Biopsies|Renal biopsy was required to confirm the diagnosis of acute rejection. However, due to the non-interventional nature of this study, biopsy could not be mandatory. The decision of whether to perform a biopsy was made at the discretion of the investigator and the result was collected if performed.|At 6 months (±1 month) after initiating Rapamune administration or at the time of completion of Rapamune administration, whichever was earlier.|Efficacy Analysis Set: Participants with efficacy data recorded on the case report form (CRF) at 6 months (±1 month) after initiating Rapamune administration or at the time of completing Rapamune administration (whichever was earlier) were included in the Efficacy Analysis Set.||Percentage of participants||95% Confidence Interval|Number
138443|NCT00484094|Primary|Percentage of Participants With Clinically Significent Abnormal Laboratory Test|Laboratory test was not mandatory because this study was a non-interventional study.|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|This analysis was not performed because laboratory data were not collected during the study.|||||
138444|NCT00484094|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|All AEs reported after the start of administration of Rapamune were considered as treatment-emergent AEs and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely”, were considered as AEs whose causal relationship to the study drug could not be excluded and classified as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.|Six months (±1 month) after initiating Rapamune administration or until completion of Rapamune administration, whichever was earlier.|Safety Analysis Set||Percentage of participants|||Number
138445|NCT00483938|Secondary|Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)|End of treatment response (ETR) was defined as “Success” if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as “Success”, if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as “Success”, if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point.|Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)|ITT population||percentage of participants|||Number
138446|NCT00483938|Secondary|Percentage of Participants With SVR (Groups C, D, E, and F)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.|At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)|ITT. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.||percentage of participants|||Number
138447|NCT00483938|Primary|Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)|SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.|At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)|Intent-to-treat (ITT) population included randomized participants who received at least one dose of study medication and who had a baseline HCV-RNA which was at least 15 IU/mL. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.||percentage of participants|||Number
138448|NCT00482729|Other Pre-specified|Number of Patients With A1C < 7.0% at Week 44||Week 44|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.||Participants|||Number
138449|NCT00482729|Other Pre-specified|Change From Baseline in A1C at Week 44|A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.|Baseline and Week 44|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.||Percent||95% Confidence Interval|Least Squares Mean
138450|NCT00482729|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.||mg/dL||95% Confidence Interval|Least Squares Mean
138451|NCT00482729|Secondary|Number of Patients With A1C < 7.0% at Week 18||Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.||Participants|||Number
138452|NCT00482729|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 18|A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.||Percent||95% Confidence Interval|Least Squares Mean
138453|NCT00482703|Other Pre-specified|Number of Participants With Progression-Free Survival (PFS) at Months 0 - 24 (PFS Life Table)|Progressed disease=achieving a CHR and subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose and an increase in white blood cell count (doubling of the count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done at least 2 weeks apart); meeting the criteria of accelerated or blastic phase CML at any time; having an MCyR and subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)||participants|||Number
138454|NCT00482703|Other Pre-specified|Number of Participants With CHR at Months 0 - 24 (Duration of MCyR Life Table)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 7)||participants|||Number
138455|NCT00482703|Other Pre-specified|Number of Participants With Major Cytogenetic Response at Months 0 - 24 (Duration of MCyR Life Table)|MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in BM: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|Months 0, 4, 8, 12, 16, 20, 24|Treated participants. Median duration was not reached at the time of this report (see Outcome Measure 6)||participants|||Number
138456|NCT00482703|Secondary|Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants||percentage of participants||95% Confidence Interval|Number
138457|NCT00482703|Secondary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study|Cytogenetic response (CyR) as reflected in the major cytogenetic response was determined by bone marrow (BM) aspirates and are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each BM sample. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), or Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|All treated participants||percentage of participants||95% Confidence Interval|Number
138458|NCT00482703|Secondary|Mutational Spectrum of BCR-ABL|Number of participants with a particular BCR-ABL mutation at Baseline and End-of-Study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants||participants|||Number
138459|NCT00482703|Secondary|Expression of BCR-ABL Gene Mutations of RNA (mRNA)|Number of participants with positive (>= 2.0 log copies/mg) and negative (<2.0 log copies/mg) expression of mRNA at Baseline and at end of study.|Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.)|Treated participants||participants|||Number
138460|NCT00482703|Secondary|Progression-Free Survival (PFS)|Progressed disease=achieving a CHR & subsequently no longer meeting criteria consistently over a consecutive 2-week period after starting maximum dose; no CHR after receiving maximum dose & increase in white blood cell count (doubling of count from lowest value to >20,000/mm3 or an increase by >50,000/mm3 on 2 assessments done ≥2 weeks apart); meeting the criteria of accelerated or blastic phase chronic myeloid leukemia at any time; having an MCyR & subsequently no longer meeting the criteria for MCyR after starting maximum dose; or having a >=30% absolute increase in number of Ph+ metaphases.|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Median months of progression-free survival was not reached at the time of this report. See corresponding life table in Outcome Measure 16.||months||95% Confidence Interval|Median
138461|NCT00482703|Secondary|Duration of CHR|The duration of CHR were measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death. Subjects who neither progress nor die were censored on the date of their last hematologic assessment.|measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death|Median duration of CHR was not reach at the time of this report. See corresponding life table presented in Outcome Measure 15.||months||95% Confidence Interval|Median
138462|NCT00482703|Secondary|Time to CHR|Time to CHR = time from first dose of Dasatinib until the first day CHR criteria are met (provided subjects achieved a cCHR). CHR=all of the following criteria: white blood cell count ≤ upper limit of normal; platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met|Treated participants - responders||months||95% Confidence Interval|Median
138472|NCT00483756|Secondary|Number of Participants With Clinically Significant Infections|Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator.|Baseline up to Month 12|FAS: all randomized participants who received at least 1 dose of study medication.||participants|||Number
138463|NCT00482703|Secondary|Duration of MCyR|The duration of MCyR will be measured from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death. Subjects who neither progress nor die will be censored on the date of their last cytogenetic assessment.MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Philadelphia-positive (Ph+) Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death|Median duration was not reached at the time of this report; see Outcome Measure 14 for corresponding life table.||months||95% Confidence Interval|Median
138464|NCT00482703|Secondary|Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics|Blood sample collection for pharmacokinetic (PK) analysis that will contribute to PK modeling.|Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.|Blood samples were collected for PK to be included in separate population PK analyses. No study specific PK analyses were planned for this report.||participants|||Number
138465|NCT00482703|Secondary|Time to Major Cytogenetic Response (MCyR)|Time to MCyR is defined as the time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met. MCyR = a complete and a partial cytogenetic response (CyR), based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow sample. Percentage of Ph+ Cells in Metaphase in bone marrow: Complete Cytogenetic Response (CCyR) = 0; Partial Cytogenetic Response (PCyR) 1 - 35|time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met|Treated participants - responders||months||95% Confidence Interval|Median
138466|NCT00482703|Secondary|Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils < 20%; no extramedullary involvement. A confirmed CHR (cCHR) is obtained when all above criteria are maintained for at least 28 days after they are first met. All hematologic responses can begin only 14 days after the dosing start date.|Week 24|All treated participants||percentage of participants||95% Confidence Interval|Number
138467|NCT00482703|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.|All treated participants||participants|||Number
138468|NCT00482703|Primary|Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24|Cytogenetic responses (CyR) are based on the percentage of Philadelphia-positive (Ph+) metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), and Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|Week 24|All treated participants||percentage of participants||95% Confidence Interval|Number
138469|NCT00483756|Secondary|Severity of Dyspepsia Assessment (SODA)|SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia;consists of 3 subscales:Pain Intensity (6-items to assess pain and intensity of abdominal [Ab] discomfort; Range (Ra):2-47, higher score= greater pain and Ab discomfort), Non-Pain Symptoms (7-items to assess severity and impact of non-pain symptoms:burping/belching,heartburn,bloating,flatulence,sour taste,nausea,and bad breath; Ra:7-35,higher scores = increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with Ab discomfort; Ra:2-23,higher scores= more satisfaction).|Baseline, Month 6, 12|Data not analyzed since the SODA instrument was found irrelevant in the treated population.|||||
138470|NCT00483756|Secondary|End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)|ESRD-SCL:43-item disease specific self-administered questionnaire. Participants’ rated question“At the moment,how much do you suffer?”for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0 - 40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.||units on a scale||Standard Deviation|Mean
138471|NCT00483756|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36: standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. Total of 11 variables were analyzed (8 subscales,2 composite subscales and Question(Q) 2 “how would you rate your health in general now?”(range 1=better, 5=worst). The score for a section (except Q2) is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.||units on a scale||Standard Deviation|Mean
138496|NCT00483717|Primary|The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|2 hours after dosing|Modified ITT||participants|||Number
138473|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using abbreviated MDRD equation. GFR by abbreviated MDRD equation= 186 * (serum creatinine)^(-1.154) * (age in years)^(-0.203) * (0.742 if female) * (1.210 if black). A normal GFR is >90 mL/min/1.73 m^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.||mL/min per 1.73 m^2||Standard Deviation|Mean
138474|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine)^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen concentration)^(-0.170) * (serum albumin concentration)^(0.318).A normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.||mL/min/1.73 m^2||Standard Deviation|Mean
138475|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using LOCF.||mL/min||Standard Deviation|Mean
138476|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) by The Nankivell Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated was estimated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 1, 3, 6, 9, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure. Missing data were imputed using Last Observation Carried Forward (LOCF).||mL/min||Standard Deviation|Mean
138477|NCT00483756|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants||||||
138478|NCT00483756|Secondary|Lymphocyte Subset|The absolute cell counts of cluster of differentiation 3 (CD3): T-lymphocytes, cluster of differentiation 19 (CD19): B-lymphocytes, and cluster of differentiation 56 (CD56): assumed natural killer cells, were determined using flow cytometry.|Month 1, 3, 6, 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure; and 'n' signifies those participants who were evaluable at given time point for each group, respectively.||cells per microliter||Standard Deviation|Mean
138479|NCT00483756|Secondary|Number of Participants Who Died||Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
138480|NCT00483756|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of clinical BPAR diagnosed by the central pathologist or graft loss including participant death.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
138481|NCT00483756|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant death, re-transplantation, or return to dialysis for >=6 consecutive weeks.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
138482|NCT00483756|Secondary|Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)|Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: ‘suspicious’ for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who were evaluable at given time point for each group, respectively.||participants|||Number
138483|NCT00483756|Secondary|Number of Participants With Treated Clinical Acute Rejection|Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment.|Month 6, 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed): participants evaluable for this measure; and n: participants who remained at risk at given time point for each group, respectively.||participants|||Number
138484|NCT00483756|Secondary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 mg/dL and >=20% from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hrs of the time of biopsy.|Baseline up to Month 12|FAS with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.||participants|||Number
138485|NCT00483756|Secondary|Number of Participants With Progression of Chronic Allograft Lesions at Month 12|Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy [cg] + interstitial fibrosis [ci] + tubular atrophy [ct] + vascular intimal thickening [cv]).The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 12 Banff-CS greater than the implantation biopsy score indicated progression of lesions.|Month 12|Per protocol (PP) population: all randomized participants who received at least 1 dose of study treatment; excluding participants who had a protocol deviation thought to affect the analyses. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at both baseline and Month 12.||participants|||Number
138486|NCT00483756|Secondary|Glomerular Filtration Rate (GFR) at Month 6|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 6.||mL/min||Standard Deviation|Mean
138487|NCT00483756|Primary|Glomerular Filtration Rate (GFR) at Month 12|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous bolus over 5 minutes immediately after morning dosing of CP-690,550 or CsA on day of GFR evaluation. A normal GFR is greater than (>) 90 milliliter per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<) 15 mL/min indicated kidney failure.|2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12|FAS: all randomized participants who received at least 1 dose of study medication. Here, N (Number of Participants Analyzed) includes only participants with evaluable data for this measure at Month 12.||mL/min||Standard Deviation|Mean
138488|NCT00483756|Primary|Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant|Clinical BPAR was a BPAR (category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification) associated with an increase in serum creatinine of >= 0.3 milligram per deciliter (mg/dL) and >=20 percent (%) from pre-rejection baseline. The increase in serum creatinine was assessed based on the comparison of baseline and the highest serum creatinine recorded within 24 hours (hrs) of the time of biopsy.|Baseline up to Month 6|Full analysis set (FAS) with last dosing risk set: all randomized participants who received at least 1 dose of study medication, including events occurring up to 7 days after last dose. Here, N (Number of Participants Analyzed) signifies participants evaluable for this measure.||participants|||Number
138489|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|48 hours post-dosing|Modified ITT||participants|||Number
138490|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|24 hours post-dosing|Modified ITT||participants|||Number
138491|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|4 hours post-dosing|Modified ITT||participants|||Number
138492|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|3 hours post-dosing|Modified ITT||participants|||Number
138493|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1.5 hours post-dosing|Modified ITT||participants|||Number
138494|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|1 hour post-dosing|Modified ITT||participants|||Number
138495|NCT00483717|Secondary|The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point|Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain|0.5 hours post-dosing|Modified ITT||participants|||Number
138497|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|TMF from 2 to 24 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 24 hours.||Percentage of participants|||Number
138498|NCT00483704|Secondary|Percentage of Participants Reporting Total Migraine Freedom at 2 Hours Post-dose (First Migraine Attack)|TMF 2 hours post-dose, which is defined as TMF at 2 hours post-dose, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache and no reported occurrence of photophobia, phonophobia, nausea, or vomiting during the 2 hours after dosing with the study medication.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants|||Number
138499|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 48 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 48 hours post-dose after study medication administration. SPF from 2 to 48 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 48 hours after dosing with the study medication.|From 2 to 48 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 48 hrs, or a recurrence question.||Percentage of participants|||Number
138500|NCT00483704|Secondary|Percentage of Participants Reporting Sustained Pain Freedom From 2 to 24 Hours Post-dose (First Migraine Attack)|Sustained Pain Freedom (SPF) from 2 to 24 hours after study medication administration. SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication.|From 2 to 24 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population was participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hr. time point. Participants were excluded from this analysis for not having a baseline pain score, post-dose data through 24 hrs, or a recurrence question.||Percentage of participants|||Number
138501|NCT00483704|Primary|Number of Participants Discontinuing Study Medication Due to an AE|Participants discontinuing study medication due to an AE were reported for all migraine attacks.|Up to the 4th dose of study medication (up to 6 months)|The APaT Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication, they were included in that treatment group.||Participants|||Number
138502|NCT00483704|Primary|Number of Participants Experiencing an Adverse Event (AE) Within 48 Hours Post-dose (First Migraine Attack)|AEs were reported following treatment for the first migraine attack using a 48-hour post-dose window. AEs displayed are those reported by at least 4 participants in one or more treatment groups.|Up to 48 hours post-dose for the first migraine attack (up to 6 months)|The All-Patients-as-Treated (APaT) Population consisted of all participants who received at least 1 dose of study medication and were included in the treatment group according to the medication actually received. If a participant took an unassigned study medication for the first migraine attack, they were included in that treatment group.||Participants|||Number
138503|NCT00483704|Primary|Percentage of Participants Reporting Absence of Nausea 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether nausea was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for nausea severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline nausea score or post-dose data through 2 hours.||Percentage of participants|||Number
138504|NCT00483704|Primary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose phonophobia measurement prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline phonophobia score or post-dose data through 2 hours.||Percentage of participants|||Number
138505|NCT00483704|Primary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-dose (First Migraine Attack)|The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose measurement for photophobia severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline photophobia score or post-dose data through 2 hours.||Percentage of participants|||Number
138535|NCT00483379|Secondary|Change From Baseline in Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36) at Week 52|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Baseline, Week 52|Full analysis population of participants >= 14 years old.||units on a scale||Standard Deviation|Mean
138506|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief Consistency at 2 Hours Post-dose|Pain Relief Consistency (PRC) at 2 hours post-dose, defined as having achieved PR at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PR response arising from the administration of the 1 telcagepant treated migraine attack will count as one of the 3 positive PR responses needed to fulfill the criteria for PRC.|2 hours post-dose (up to 6 months)|The MFAS Population was defined as all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.||Percentage of participants|||Number
138507|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom Consistency at 2 Hours Post-dose|Pain Freedom Consistency (PFC) at 2 hours post-dose, defined as having achieved PF at 2 hours post-dose on at least 3 treated migraine attacks. Note that for the control groups, a positive PF response arising from the administration of the 1 talcagepant treated migraine attack will count as one of the 3 positive PF responses needed to fulfill the criteria for PFC.|2 hours post-dose (up to 6 months)|The modified FAS (MFAS) Population consisted of all participants who experienced at least either 2 failures or 3 successes, regardless of whether or not they had data for 4 migraine attacks, and recorded baseline severity for at least 1 of the treated migraine attacks.||Percentage of participants|||Number
138508|NCT00483704|Primary|Percentage of Participants Reporting Pain Relief at 2 Hours Post-dose (First Migraine Attack)|Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The FAS Population included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants|||Number
138509|NCT00483704|Primary|Percentage of Participants Reporting Pain Freedom at 2 Hours Post-dose (First Migraine Attack)|Pain Freedom (PF) at 2 hours post-dose (first migraine attack), with pain freedom defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain.|2 hours post-dose for the first migraine attack (up to 6 months)|The full-analysis set (FAS) included participants treated that migraine attack, and had both a baseline value and at least 1 post-dose efficacy measurement for pain severity prior to, or including, the 2-hour time point. Participants were excluded from this analysis who did not have a baseline pain score or post-dose data through 2 hours.||Percentage of participants|||Number
138510|NCT00483652|Secondary|Change in Lower Extremity Manual Muscle Test [LEMMT]|Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77|||units on a scale||Standard Deviation|Mean
138511|NCT00483652|Primary|Responders Based Upon the Timed 25-Foot Walk [T25FW]|A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)|Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77|Modified Intention-to-Treat [ITT] population||participants|||Number
138512|NCT00483574|Other Pre-specified|Safety Overview After Any Vaccination in Participants Who Received MMR+V||Day 0 to 7 Post-vaccination|Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.||Percentage of participants|||Number
138513|NCT00483574|Primary|Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.|"Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.~Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability"|Day 0 to 7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.||Percentage of participants|||Number
138514|NCT00483548|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Scores at Week 6|Q-LES-Q is a 16-item subject rated scale to measure satisfaction with areas of daily functioning (physical health, social relationships, medication, and overall life satisfaction); rated on a 5-point Likert scale: higher scores indicate greater enjoyment and satisfaction with general life activities. Scores for items 1 to 14 are summed for a total score and converted to 0 to 100 range. Items 15 and 16 measure satisfaction with medication and overall satisfaction and are analyzed separately. Change calculated as a difference between post-baseline observation and baseline Q-LES-Q score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138515|NCT00483548|Other Pre-specified|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Scores|AIMS is a clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe); items 11 to 14 are No or Yes response to dental status and sleep movements and are assessed separately. AIMS total score is sum of first 7 items. Change calculated as a difference between post-baseline observation and baseline AIMS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138516|NCT00483548|Other Pre-specified|Change From Baseline in Barnes Akathisia Rating Scale (BARS or BAS)|BARS is a clinician rated scale to evaluate akathisia associated with use of antipsychotic medications: objective motor restlessness, range 0 to 3; subjective complaints of restlessness and associated distress, range 0 to 3; global clinical assessment of akathisia, range 0 to 5. Higher scores indicate more affected. Change calculated as a difference between post-baseline observation and baseline BARS score values.|Baseline, Week 2, Week 4, Week 6|ITT; Summarized as Global BARS; individual scores not summarized; (n)=number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138517|NCT00483548|Other Pre-specified|Change From Baseline in Simpson Angus Scale (SAS) Score|SAS is a clinician rated 10-item scale to measure extrapyramidal side effects (Parkinsonism or Parkinsonian side effects induced with antipsychotics); rated on a 5-point scale with range 0 (absence of condition) to 4 (presence of condition in extreme form). Global score is sum of all scores divided by the total number of items. Change calculated as a difference between post-baseline observation and baseline SAS score values.|Baseline, Week 2, Week 4, Week 6|ITT; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138518|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 4 and 5)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||days||Standard Deviation|Mean
138519|NCT00483548|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 6 (Items 1 Through 3)|SDS is a 5-item subject rated scale to measure the extent to which work and or school, social life and or leisure activities, and home life and or family responsibilities were impaired by psychiatric illness. Items 1 to 3 rated on 11-point scale ranging 0 (not at all) to 10 (extremely affected). Total score 0 to 30; higher score indicates greater impairment; items 4 and 5 report number of days in the last month (0 to 31) subject missed work or school or was unproductive and are rated separately. Change calculated as a difference between post-baseline observation and baseline SDS score values.|Baseline, Week 6|ITT; ET visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138520|NCT00483548|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Scale at Week 6|GAF is a clinician rated scale to measure the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale (single score of 1 to 100) with 100 indicating a superior level of function. Change calculated as a difference between post-baseline observation and baseline GAF score values.|Baseline, Week 6|ITT; observed cases; Early Termination (ET) visits re-slotted to regular weekly visits according to duration since first dosing date; ET Visit only includes observations from visits that did not meet windowing criteria; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138521|NCT00483548|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138522|NCT00483548|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint.|Baseline, Week 2, Week 4, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138523|NCT00483548|Secondary|CGI-Improvement Score|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6|ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
138524|NCT00483548|Secondary|Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.||scores on scale||Standard Deviation|Mean
138549|NCT00483327|Secondary|Duration of Response|For each patient, assessed every 12 weeks during treatment and every 6 months during follow-up.|up to 4 years||09/2017||||
138525|NCT00483548|Secondary|Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.||scores on scale||Standard Deviation|Mean
138526|NCT00483548|Secondary|Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6|Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected.|Baseline, Week 6|ITT; LOCF||participants|||Number
138527|NCT00483548|Secondary|MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6|Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as ([A-B]/B*100): A=value at observation; B=baseline value.|Week 6|ITT; LOCF||participants|||Number
138528|NCT00483548|Secondary|MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6|Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms).|Week 6|ITT; Last observation carried forward (LOCF)||participants|||Number
138529|NCT00483548|Secondary|Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.|Baseline, Week 6|ITT||scores on scale||Standard Deviation|Mean
138530|NCT00483548|Primary|Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.|Baseline, Week 6|Intent to Treat analysis set (ITT): all randomized subjects who received at least 1 dose of double-blind treatment and had at least 1 post-baseline primary efficacy evaluation.||scores on scale||Standard Deviation|Mean
138531|NCT00483496|Secondary|Adverse Events||all over the study||||||
138532|NCT00483496|Primary|Assessment of the Minimal Urticaria Dose (MUD) on Each Test Site, After Application of the Test Products|"MUD was defined as the minimal dose for occurrence of objective signs of SU (wheal, flare) under exposure to the solar simulator. Results are expressed as photodermatosis protection factor (PPF), calculated by dividing the MUD of protected skin (sessions 2 to 5) by the MUD of the unprotected skin (session 1) in each treatment group.~Procedure: At baseline, 4 grids of 8 adjacent test areas on the patient back were defined. The defined test areas of each grid were applied with the respective test products by the investigating staff at the beginning of each session, according to a predefined randomisation schedule. Grids were sequentially irradiated one by one with 1 MUD (session 2) , 3 MUD (session 3) , 5 MUD (session 4), and 7 MUD (session 5), respectively. After product removal at each session, patients were observed for 30 min for the development of SU lesions. Final reading of all areas was performed at the end of each session, by the investigator masked to product site assignment."|During each one of the 5 sessions, at study day|||Photodermatosis Protection Factor||Full Range|Mean
138533|NCT00483379|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events During the Treatment Period|Overall safety summary of participants experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment.|Day 1 up to Week 52|Safety population comprised of all participants who received intervention.||participants|||Number
138534|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Motor Function Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; motor function decline primarily based on Gross Motor Function Measure 66 and Pompe Pediatric Evaluation of Disability Inventory results is summarized. Participants could gain motor function (improve), had no change (declined stopped), or continued loss (worsened). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in motor function while on standard treatment.||participants|||Number
138550|NCT00483327|Secondary|Toxicity and Tolerability|Patients with adverse events (AEs) which were possibly, probably, or definitely related to the treatment. AEs were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) 3.|up to 36 months|Any patient with at least one dose of treatment.||participants|||Number
138536|NCT00483379|Secondary|Baseline Values for Normative Physical Component Summary of Medical Outcomes Study Short Form Health Survey (SF-36)|Health related quality of life is measured using the Physical Component Summary (PCS) score of the Medical Outcomes Study (MOS) Short Form Health Survey (SF-36) for participants ≥14 years of age. SF-36 normative-based scoring has a mean of 50 and a standard deviation of 10. Higher scores represent better quality of life.|Day 0|Full analysis population of participants >= 14 years old.||units on a scale||Standard Deviation|Mean
138537|NCT00483379|Secondary|Change From Baseline in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at Week 52|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Change from baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near “0” reflecting low capability and scores near “100” reflecting high capability.|Baseline, Week 52|Full analysis population||units on a scale||Standard Deviation|Mean
138538|NCT00483379|Secondary|Baseline Values in Mobility as Measured by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI)|"The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. Baseline results for the mobility domain are reported. Scaled scores are used as an evaluative measure of change in performance over time with acquisition of new skills or new levels of independence. The range of scores is from 0-100 with scores near 0 reflecting low capability and scores near 100 reflecting high capability."|Day 0|Full analysis population||units on a scale||Standard Deviation|Mean
138539|NCT00483379|Secondary|Change From Baseline in Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results at Week 52|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Baseline, Week 52|Full analysis population||units on a scale||Standard Deviation|Mean
138540|NCT00483379|Secondary|Baseline Values of Raw Scores for Gross Motor Function Measure 66 (GMFM-66) Results|The Gross Motor Function Measure 66 contains sixty-six questions with a total raw score range of 0 - 198. Raw scores are derived from the following dimensions: Lying and rolling = 12; Sitting = 45; Crawling and kneeling = 30; Standing = 39; Walking, running and jumping = 72. Higher scores indicate better gross motor functions.|Day 0|Full analysis population||units on a scale||Standard Deviation|Mean
138541|NCT00483379|Secondary|Change From Baseline in Body Strength Measured by the Manual Muscle Testing (MMT) Total Score at Week 52|Body strength is measured by the MMT score on a scale of 0-10 with higher scores representing greater body strength.|Baseline, Week 52|Full analysis population of participants >= 8 years old. Due to the age restriction and small study population, the number of participants analyzed is too small for results to be meaningful.|||||
138542|NCT00483379|Secondary|Change From Baseline in Ventilator Use at Last Assessment (Approximately Week 52)|The change from baseline in ventilator use at the last assessment is summarized as improved (less use of ventilator support), no change, worsened (increased use of ventilator support), and did not use ventilator support.|Baseline, approximately Week 52|Full analysis population. The participant in the worsened category died after week 52.||participants|||Number
138543|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass Index (LVMI) at Week 52|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline and after 12 months of treatment (Week 52). Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Baseline, Week 52|Full analysis population of participants with LVMI data at both timepoints||g/m^2||Full Range|Median
138544|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass Index (LVMI)|Cardiac pathophysiology was assessed by a central cardiologist using left ventricular mass index (LVMI) measured by echocardiogram at Baseline. Left Ventricular Mass is adjusted to the participant's body surface area in the calculation of LVMI.|Day 0|Full analysis population of participants with LVMI data||g/m^2||Full Range|Median
138545|NCT00483379|Secondary|Change From Baseline in Left Ventricular Mass (LVM) Z-Score at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children’s Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Baseline, Week 52|Full analysis population of participants with LVM data at both timepoints||Z-score||Full Range|Median
138546|NCT00483379|Secondary|Baseline Values for Left Ventricular Mass (LVM) Z-Scores|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. Negative values indicate a smaller than mean LVM and values higher than 0 indicate a larger LVM than the mean. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy. The Z-scores for all parameters are calculated with reference to the normative data from the Children’s Hospital, Boston, MA (Colan, 1992, J Am Coll Cardiol) based on the reference population with matched body surface area (BSA). Z-scores for LVM were provided by the central cardiologist.|Day 0|Full analysis population of participants with LVM data||Z-score||Full Range|Median
138547|NCT00483379|Primary|Participants' Efficacy Response During the Treatment Period as Compared to Baseline for Participants With Respiratory Decline on Standard Treatment|Participants were enrolled based on clinical decline or sub-optimal clinical response in cardiac, respiratory and/or motor function parameters pre-study while on standard treatment. Each participant was evaluated at Week 52 for change from baseline in the criteria that declined; respiratory decline as measured by change in ventilator use is summarized in this outcome. Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support). Each participant served as his or her own control.|Baseline, Week 52|All participants who enrolled due to decline in respiratory function while on standard treatment.||participants|||Number
138548|NCT00483327|Secondary|Number of Women Who Became Pregnant||up to 3 years after the treatment for each patient|Only 7 participants in the trial pursued pregnancy.||participants|||Number
138551|NCT00483327|Primary|Best Pathologic Responses|Patients are evaluated every 12 weeks while on treatment. The response is evaluated by endometrial biopsy or dilation and curettage (D&C)/hysteroscopy. Complete response (CR) is defined as endometrial sampling is read as normal or proliferative endometrium. Partial response (PR) is defined as the biopsy sample has changed on the endometrial evaluation scale by at least one level towards normal. Stable disease (SD) is defined as no change in pathology between the index and follow-up sample. Progressive disease (PD) is defined the follow-up sample has changed towards neoplasia on the endometrial evaluation scale by at least one level or imaging is concerning for myometrial invasion or extrauterine disease such that conservative management is no longer medically appropriate.|up to 24 months|Patient who were able to complete at least one full course (12 weeks) of treatment||participants|||Number
138552|NCT00483262|Secondary|Progression-Free Survival|Median time to progression or death|10 months|||month||95% Confidence Interval|Median
138553|NCT00483262|Primary|Best Response to Combination Treatment|Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma|10 months|All patients included in analysis||percentage of patients||90% Confidence Interval|Number
138554|NCT00483262|Primary|Toxicity. Number of Patients With Specific Toxicities Are Reported.|Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.|10 months|Any patient who was treated was included in the analysis.||percentage of patients||95% Confidence Interval|Number
138555|NCT00483184|Secondary|Time to Initial Response, Oral Ulcer Sustained Response, Oral Ulcer Recurrence, Time to Recurrence, Pain Associated With Oral Lesions, General Well-Being, Safety||12 weeks||||||
138556|NCT00483184|Primary|Comparison of Patients Experiencing a Sustained Response for Each Treatment Arm.|A patient with a 75% or greater decrease in total OU for three visits was considered a “sustained responder”.|(0-12 weeks)|||patients with sustained response|||Number
138557|NCT00483119|Secondary|Ability to be Weaned Off Steroids||Measured 6 and 10 weeks after initiation of IVIg treatment|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
138558|NCT00483119|Secondary|Toxicity of Treatment: Measured in Renal Toxicity, Myelosuppression or Hepatic Toxicity||Throughout course of study|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
138559|NCT00483119|Primary|Serum Levels of Pemphigus Antibodies||6-10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
138560|NCT00483119|Primary|Clinical Outcome: Extent and Severity of Disease||6 - 10 weeks after initiation of therapy|Sadly, the trial PI, Dr. Jean-Claude Bystryn, died on August 19, 2010. As a result the study could not be completed and an analysis of the data collected was not performed.|||||
138561|NCT00483041|Secondary|Volume at Distribution (Vz)|Vz of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Milliliter||Geometric Coefficient of Variation|Geometric Mean
138562|NCT00483041|Secondary|Volume at Steady State (Vss)|Vss of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Milliliter||Geometric Coefficient of Variation|Geometric Mean
138563|NCT00483041|Secondary|Terminal Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Day||Geometric Coefficient of Variation|Geometric Mean
138564|NCT00483041|Secondary|Clearance (CL)|CL of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Milliliters per day||Geometric Coefficient of Variation|Geometric Mean
138565|NCT00483041|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Percentage of Total Area||Geometric Coefficient of Variation|Geometric Mean
138566|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
138567|NCT00483041|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
138568|NCT00483041|Secondary|Peak Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
138569|NCT00483041|Secondary|Time to Peak Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 7, 14, 15, 28, 56, 84, and 126|All participants who were randomized (n=11), received MEDI-528 (n=5), and had pharmacokinetic samples for analysis (n=4)||Day||Geometric Coefficient of Variation|Geometric Mean
138570|NCT00483041|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 28, 56, 84, and 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). One subject in the 9 mg/kg group had no sample collected on Day 126.||Participants|||Number
138571|NCT00483041|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).||Participants|||Number
138572|NCT00483041|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).||Participants|||Number
138573|NCT00483041|Primary|Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL)|The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.|Baseline (2 to 4 weeks prior to Day 0) and Day 15|All subjects who were randomized (n=11), received at least one dose of investigational product (MEDI-528 or placebo; n=10), and completed the 2-day BAL and segmental allergen challenge procedures at baseline (2-4 weeks prior to Day 0) and on Days 14 and 15 (n=2; 1 subject in each treatment group).||Picograms per milliliter|||Number
138574|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence for at Least Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|At least Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
138575|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 7 through Week 11|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
138576|NCT00483002|Primary|Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7|Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No).|Week 3 through Week 7|Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
138577|NCT00482911|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16 months|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.||Participants|||Number
138578|NCT00482911|Primary|Response Rate (Complete and Partial Response)|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years|Cohort 2 = 9 patients. Two patients received Dose B-QD in cycle 1 as outlined in participant flow. Seven patients received Dose D-QD in cycle 1 as outlined in participant flow.||Participants|||Number
138579|NCT00482625|Secondary|Number of Participants Reported at Least 1 Adverse Event With a Grade of 3 and Above|The worst grade of pre-listed toxicity will be summarized by participant and by visit for each treatment group. Descriptive statistics (frequencies and percents) will be used to summarize data and hypotheses about group differences will be tested where appropriate.|Up to 20 weeks|||participants|||Number
138580|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-420 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-420)|20 weeks|||ng/g||Standard Deviation|Mean
138581|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-420 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-420)|20 weeks|||ng/mL||Standard Deviation|Mean
138582|NCT00482625|Secondary|Pancreas Calculated Concentration - OSI-774 (ng/g)|Pancreatic tissue concentration levels of Erlotinib (OSI-774)|20 weeks|||ng/g||Standard Deviation|Mean
138583|NCT00482625|Secondary|Plasma Calculated Concentration - OSI-774 (ng/mL)|Plasma concentration levels of Erlotinib (OSI-774)|20 weeks|||ng/mL||Standard Deviation|Mean
138584|NCT00482625|Primary|Reduction in Number of Positive IPMN Celss and Staining Intensity After Treatment|Number of participants showed a reduction in number of positive IPMN cells and staining intensity after treatment|Pre-treatment and post-treatment|||participants|||Number
138585|NCT00482612|Secondary|Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period|The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.||Number of participants|||Number
138586|NCT00482612|Secondary|Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period|The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Day 1 to Day 15|The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.||Number of participants|||Number
138661|NCT00482014|Secondary|Phase 2 - Median Survival||Phase 2 randomization to death as the result of any cause up to 30.0 month|All randomized participants in Study Phase 2.||months||95% Confidence Interval|Median
138587|NCT00482612|Secondary|Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication and had baseline and at least one post-baseline measurement for at least one efficacy assessment.||Minutes||Standard Deviation|Mean
138588|NCT00482612|Primary|Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period|TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.|Day 1 to Day 15|The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication, and had baseline and at least one post-baseline measurement for at least one efficacy assessment.||Minutes||Standard Deviation|Mean
138589|NCT00482547|Other Pre-specified|Number of Subjects With a sUTI Catheterized for >=48 Hours.|sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days or 48 hours after catheter was removed|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.||Participants|||Number
138590|NCT00482547|Other Pre-specified|Number of Subjects With a bUTI Catheterized for >=48 Hours.|bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.||Participants|||Number
138591|NCT00482547|Secondary|Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL|The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI|10 days|Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.||Participants|||Number
138592|NCT00482547|Secondary|Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.||Days||Standard Deviation|Median
138593|NCT00482547|Secondary|Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 24 hours to 10 days|Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.||Days||Standard Deviation|Median
138594|NCT00482547|Secondary|Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours|The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>= 48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.||Days||Standard Deviation|Median
138595|NCT00482547|Primary|Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours|Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.|>=48 hours to 10 days|Efficacy Evaluable (48) population: Intent-to-treat (ITT) subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a bUTI after catheter insertion.||Days||Standard Deviation|Median
138596|NCT00482547|Secondary|Percentage of Participants With a bUTI After Catheterization for >= 48 Hours|The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion.|>=48 hours to 10 days|Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion.||Percentage of Participants with a bUTI|||Number
138597|NCT00482274|Secondary|Time to Death From Any Cause|Due to the limited enrollment, this analysis was not completed.|measured at date of death (no estimate available)|Due to the limited enrollment, this analysis was not completed.||Days||95% Confidence Interval|Median
138598|NCT00482274|Secondary|Time to Androgen Independent State|Due to the limited enrollment, this analysis was not completed.|Measured at date of documented androgen independence (no estimate available)|Due to the limited enrollment, this analysis was not completed.||Days||95% Confidence Interval|Median
138599|NCT00482274|Secondary|Time to Metastatic Disease|Due to the limited enrollment, this analysis was not completed.|Measured at Time of documented metastases (no historical estimate is available)|Due to limited enrollment, this analysis was not completed||Days||95% Confidence Interval|Median
138600|NCT00482274|Secondary|Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)|Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.|Average days to develop recurrence from treatment start date amount applicable participants|Due to the limited enrollment, this analysis was not completed.||Days||Standard Deviation|Mean
138601|NCT00482274|Primary|Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml|Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.|While receiving study treatment (approximately 6 months)|Analysis includes all subjects who completed study regimen of 6 cycles.||participants|||Number
138602|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior experience of systemic or topical treatment for psoriasis were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
138603|NCT00482170|Secondary|Influence of Co-morbidities on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Co-morbidities included current usage of tobacco and alcoholic beverages. Numbers of participants with and without co-morbidities were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
138604|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. The DLQI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Standard Deviation|Mean
138605|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant’s global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. The participant’s assessment of psoriasis score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||mm||Standard Deviation|Mean
138606|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participant's assessment of general health was measured on 100mm line visual analog scale (VAS). 0mm = extremely bad to 100mm = very well. The participant’s assessment of general health score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||mm||Standard Deviation|Mean
138607|NCT00482170|Secondary|Influence of Psoriasis Area Severity Index (PASI) on Participant Perception|Participant perception:assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using multiple correspondence analysis and ascending hierarchical classification. PASI: combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. While assessing, body was divided into 4 sections: head, upper extremities, trunk, lower extremities. PASI score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Standard Deviation|Mean
138608|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. PGA of psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. The PGA score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Full Range|Median
138609|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The duration of psoriasis was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||years||Standard Deviation|Mean
138610|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior self-injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
138611|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Numbers of participants with and without prior injection experience were determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
138612|NCT00482170|Secondary|Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception|Participant perception: assessed with 26 questions of device attribute and participant questionnaire. Based on scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and ascending hierarchical classification. The 13-item short form of PAM survey assessed participants' knowledge, skill, and confidence for self-management; score range 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. PAM score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Standard Deviation|Mean
138613|NCT00482170|Secondary|Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception|Participant perception: assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to 26 questions, participants were divided into 3 clusters (very satisfied, satisfied, less satisfied) using multiple correspondence analysis and an ascending hierarchical classification. Psychological status: assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. HAD score was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||units on a scale||Full Range|Median
138614|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of participants corresponding to each socio-educational level (reading or writing, high school or baccalaureate level, university level) was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
138615|NCT00482170|Secondary|Influence of Gender on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. Number of female and male participants was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||participants|||Number
138616|NCT00482170|Secondary|Influence of Age on Participant Perception|Participant perception was assessed with the 26 questions of the device attribute and participant questionnaire. Based on the scores assigned to the 26 questions, participants were divided into 3 clusters (very satisfied, satisfied and less satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The age was determined for each cluster of participants.|Baseline|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.||years||Standard Deviation|Mean
138662|NCT00482014|Secondary|Phase 2 - Time to Progression|Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Phase 2 randomization to measured disease progression up to 24 months|All randomized participants in Study Phase 2.||months||95% Confidence Interval|Median
138617|NCT00482170|Secondary|Short Form State-Trait Anxiety Inventory (SF STAI) Global Score|SF-STAI is a 6 item short form. Global score = sum of coded answers/number of answered questions multiplied by 6, with answers coded on a 4 point Likert scale, where 1 = least anxious and 4 = most anxious. The global score ranges from 6 to 24, where higher score shows greater anxiety.|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||units on a scale||Standard Deviation|Mean
138618|NCT00482170|Secondary|Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection|"Side effects related to administration were assessed by participant's response to question, Do you experience pain during or immediately after the injection? scored on a 5-point Likert scale (0= none to 4= severe)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138619|NCT00482170|Secondary|Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks|"Device characteristics were assessed by participant's response to question, How much does the device look like something you would feel comfortable to use? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138620|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Feel of Device|"Device characteristics were assessed by participant's response to question, How much do you like the feel of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138621|NCT00482170|Secondary|Device Characteristics Based on Response to Question Concerning Look of Device|"Device characteristics were assessed by participant's response to question, How much do you like the look of the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138622|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection|"Fear of Device was assessed by participant's response to question, Are you emotionally distressed or anxious about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138623|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device|"Fear of Device was assessed by participant's response to question, Do you dislike injecting yourself with this device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138624|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin|"Fear of Device was assessed by participant's response to question, How nervous do you feel about inserting the needle into your skin? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138625|NCT00482170|Secondary|Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections|"Fear of Device was assessed by participant's response to question, How nervous do you feel about your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138626|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection|"Confidence in injection device was assessed by participant's response to question, How confident are you that you injected yourself successfully? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138627|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process|"Confidence in injection device was assessed by participant's response to question, Are you confident that you have good control over the injection process? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138628|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device|"Confidence in injection device was assessed by participant's response to question, How confident are you that you can inject yourself properly with the device? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138629|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time|"Confidence in injection device was assessed by participant's response to question, How confident are you that you inject the right amount of medicine every time? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
139144|NCT00476008|Secondary|Trail Making Test - Part A|A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning.|baseline and 12 months|||seconds||Standard Deviation|Mean
138630|NCT00482170|Secondary|Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections|"Confidence in injection device was assessed by participant's response to question, How confident are you in your management of your injections? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138631|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with travelling on holiday or business or visiting? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138632|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity|"Convenience of injection device was assessed by participant's response to question, Do you think injecting etanercept will interfere with your usual daily activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138633|NCT00482170|Secondary|Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity|"Convenience of injection device was assessed by participant's response to question, How much do you think injecting etanercept will interfere with your ability to enjoy social or leisure activities? scored on a 5-point Likert scale (0= not at all to 4= very much)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation.||participants|||Number
138634|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)|"Ease of Use of Injection Device was assessed by participant's response to question, How long does it take to perform the injection, including any preparation and disposal? where time spent was recorded in minutes and categorized into 5 categories, ranging from 'less than 5 minutes' to 'more than 30 minutes'."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
138635|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting|"Ease of use of injection device was assessed by participant's response to question, Did you feel any hand discomfort whilst using the device? scored on a 5-point Likert scale (0= none to 4= extreme)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
138636|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting|"Ease of use of injection device was assessed by participant's response to question, How easy is it to hold the device whilst injecting? scored on a 5-point Likert scale (0= very easy to 4= very difficult)"|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
138637|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete|"Ease of use of injection device was assessed by participant's response to question, How easy is it to know when the injection is completed? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
138638|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to dispose of the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
138639|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to use the device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
138640|NCT00482170|Secondary|Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device|"Ease of use of injection device was assessed by participant's response to question, How easy was it to perform an injection with this device? scored on a 5-point Likert scale (0= very easy to 4= very difficult)."|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||participants|||Number
139411|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years|Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).|Days 1 to 7|The analysis was performed on the safety population.||Subjects|||Number
138641|NCT00482170|Secondary|Influence of Prior Injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138642|NCT00482170|Secondary|Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of systemic treatment or topical medication for psoriasis. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138643|NCT00482170|Secondary|Influence of Co-morbidities on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Co-morbidities categories were defined based on current usage of tobacco and alcoholic beverages. Participants were divided into categories, yes and no, for both current tobacco usage and current alcohol usage.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138644|NCT00482170|Secondary|Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. Score categories were defined based on quartiles of DLQI scores observed. Participants were divided into quarters: =< 8, > 8 to 13, > 13 to 18, > 18.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138645|NCT00482170|Secondary|Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant’s global assessment of psoriasis was measured using a 100 mm VAS, with 0 = no activity and 100 = extremely active psoriasis. Score categories were defined based on quartiles of participant’s global assessment of psoriasis scores observed. Participants were divided into quarters: =< 63, > 63 to 76, > 76 to 88, > 88.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138646|NCT00482170|Secondary|Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. Participant's assessment of general health was measured on 100 millimeter (mm) line visual analog scale (VAS). 0 mm = extremely bad to 100 mm = very well. Score categories were defined based on quartiles of VAS score observed. Participants were divided into quarters: =< 48, > 48 to 67.25, > 67.25 to 84, > 84.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138647|NCT00482170|Secondary|Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PASI: combined assessment of lesion severity and area affected into single score; range: 0= no disease to 72= maximal disease. Score categories were defined based on quartiles of PASI score observed. Participants were divided into quartiles: =< 11.2, > 11.2 to 16.2, > 16.2 to 21.9, > 21.9.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138648|NCT00482170|Secondary|Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and 'Almost clear' includes all participants who were scored as a 0 or 1. Score categories were defined based on quartiles of PGA scores observed. Participants were divided into: =< 3, > 3 to 4, > 4.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138649|NCT00482170|Secondary|Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. Duration of psoriasis categories were defined based on quartiles of the duration of psoriasis observed. Participants were divided into quarters: =< 11 years, > 11 years to 19 years, > 19 years to 28 years, > 28 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138674|NCT00481845|Primary|Tumor Objective Response by MRI|Determine tumor objective response rate by MRI. (CR): Disappearance of the target lesion (PR): At least a 30% decrease in the longest diameter of the target lesion taking as reference the baseline LD (PD): At least a 20% increase in the LD of target lesion, taking as reference the baseline LD or the appearance of one or more new lesions (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the baseline LD.|1 year|||Participants|||Count of Participants
138650|NCT00482170|Secondary|Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the injection device. The categories were defined based on presence of any prior experience of self-injection. Participants were divided into categories: yes and no.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138651|NCT00482170|Secondary|Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the injection device. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Score categories were defined based on quartiles of PAM scores observed. Participants were divided into quarters: =< 47.4, > 47.4 to 56.4, > 56.4 to 68.5, > 68.5.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138652|NCT00482170|Secondary|Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score = greater satisfaction with injection device. Psychological status was assessed using participant rated questionnaire with 2 subscales for anxiety (HAD-A) and depression (HAD-D). Total score: 0 to 21 for each subscale; higher score = greater severity of symptoms. Score categories were based on quartiles of HAD-A and HAD-D scores observed. Participants were divided into quarters: =< 4, > 4 to 7, > 7 to 10, > 10 for HAD-A and =< 3, > 3 to 5, > 5 to 8, > 8 for HAD-D.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138653|NCT00482170|Secondary|Influence of Socio-educational Status on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Socio-educational status categories were defined as reading or (/) writing capacity, high school /baccalaureate level and university level.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138654|NCT00482170|Secondary|Influence of Gender on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Gender categories were defined as male and female.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. LOCF method was used.||units on a scale||Standard Deviation|Mean
138655|NCT00482170|Secondary|Influence of Age on Participant Satisfaction With Injection Device|Participant satisfaction was scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Age categories were defined based on quartiles (Q) of ages observed. Participants were divided into quarters: less than or equal to (=<) 36 years, greater than (>) 36 years to 45 years, > 45 years to 55 years, > 55 years.|Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Last observation carried forward (LOCF) method was used to impute missing values.||units on a scale||Standard Deviation|Mean
138656|NCT00482170|Secondary|Percentage of Participants Satisfied With Injection Device|Participant satisfaction was assessed by asking the question “Are you satisfied with your injection device? and using a dichotomous response: Yes or No.|Baseline, Week 4 and Week 12|mITT analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.||percentage of participants|||Number
138657|NCT00482170|Primary|Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Per-protocol (PP) analysis population included participants from mITT population who completed the study with no major protocol violations. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
138658|NCT00482170|Primary|Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population|"Participant satisfaction was assessed by asking the question, How satisfied are you with your injection device? using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied."|Week 12|Modified intent-to-treat (mITT) analysis population included all randomized participants who received at least 1 injection of study medication and had at least 1 efficacy evaluation. Here, ‘N’ (number of participants analyzed) is signifying those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
138659|NCT00482014|Primary|Phase 2 - Survival Probability at 2 Years||Phase 2 randomization up to 2 years|All randomized participants in Study Phase 2.||percentage survival||95% Confidence Interval|Mean
138660|NCT00482014|Secondary|Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 2 randomization to the end of the treatment up to 30.0 months|All randomization participants in Study Phase 2.||percentage of participants||95% Confidence Interval|Number
138663|NCT00482014|Secondary|Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events|Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section.|Phase 2 randomization to the end of the study treatment up to 30.0 months|All randomized participants who received at least 1 dose of study drug or 1 dose of radiation therapy (RT) during Study Phase 2.||participants|||Number
138664|NCT00482014|Secondary|Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)|Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Phase 1 enrollment to the end of the study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.||percentage of participants||95% Confidence Interval|Number
138665|NCT00482014|Secondary|Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)|Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death.|Phase 1 enrollment up to Week 11|All participants who were enrolled in Study Phase 1 and received at least 1 dose of study drug and 1 dose of radiation therapy.||participants|||Number
138666|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + cisplatin treatment.||milligrams/meter squared (mg/m²)|||Number
138667|NCT00482014|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin|MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).|Phase 1 enrollment to the end of study treatment up to Week 11|All participants who were enrolled in Study Phase 1 and completed at least 6 weeks of pemetrexed + carboplatin treatment.||milligram/milliliter*minute (mg/mL*min)|||Number
138668|NCT00481988|Secondary|Beck Depression Inventory II|patient self report of depressive symptoms|Two weeks|Data for the secondary outcome measure was incompletely collected and not analyzed.|||||
138669|NCT00481988|Primary|Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression).|The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS < 10 for 2 weeks.|Two weeks|20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed.||participants|||Number
138670|NCT00481871|Secondary|Progression-free Survival (PFS) Time|PFS time was calculated as the number of days from study day 1 to the date of PD or death, regardless of cause (date of PD or death – study day 1 + 1).|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study|||days||95% Confidence Interval|Median
138671|NCT00481871|Secondary|Duration of Response|Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death – date of first objective response assessment + 1)|Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study|||days||Full Range|Median
138672|NCT00481871|Primary|Objective Responses Assessed by International Workshop Criteria (IWC)|Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.|Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I|All patients who completed at least 1 cycle of treatment were included in the efficacy analysis||participants|||Number
138673|NCT00481845|Secondary|Pathologic Complete Response||1 year|CR+PR||Participants|||Count of Participants
138686|NCT00481767|Primary|Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||EL.U/mL||95% Confidence Interval|Geometric Mean
138675|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|Parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.|At Month 12|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.||subjects|||Number
138676|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|Parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.|At Month 12|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.||subjects|||Number
138677|NCT00481767|Secondary|Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|Parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.|At Month 7|The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.||subjects|||Number
138678|NCT00481767|Secondary|Number of Senegalese Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters Assessed|"Parameters assessed were:~Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).~Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title.~For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range."|At Month 7|The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.||subjects|||Number
138679|NCT00481767|Secondary|Number of Subjects With Pregnancies and Their Outcomes|Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.|Up to Month 12|The analysis was performed on the Total Vaccinated cohort on pregnant subjects.||subjects|||Number
138680|NCT00481767|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 7 and up to Month 12|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
138681|NCT00481767|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury|Up to Month 7 and from Month 7 up to Month 12|The analysis was performed on the Total Vaccinated cohort on subjects with available results.||subjects|||Number
138682|NCT00481767|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any= any unsolicited AE regardless of intensity and relationship to vaccination.~Grade 3= an unsolicited AE that prevented normal everyday activity Related= unsolicited AE assessed by the investigator as causally related to the study vaccination."|Within 30 days (Day 0-29) after any vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
138683|NCT00481767|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms were pain and swelling at the injection site. Solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature >= 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.|Within 7 days (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
138684|NCT00481767|Secondary|GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||EL.U/mL||95% Confidence Interval|Geometric Mean
138685|NCT00481767|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers >= 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 2 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||subjects|||Number
138687|NCT00481767|Primary|Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies|"A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers >= 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.~The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years."|At Month 7|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity on subjects with available results.||subjects|||Number
138688|NCT00481676|Secondary|Investigator’s Global Assessment of the Patient’s Chronic Urticaria Symptoms|The investigator made a global assessment of the patient’s chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Participants|||Number
138689|NCT00481676|Secondary|Patient’s Global Assessment of Their Chronic Urticaria Symptoms|Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.|At Baseline and at the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Participants|||Number
138690|NCT00481676|Secondary|Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24)|The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
138691|NCT00481676|Secondary|Change in the Skindex Score From Baseline to the End of the Study (Week 24)|Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients’ quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
138692|NCT00481676|Secondary|Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24)|The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
138693|NCT00481676|Secondary|Use of Concomitant and Rescue Medications|Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.|At Weeks 4, 8, 12, 16, 20, and 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Pills||Standard Deviation|Mean
138694|NCT00481676|Secondary|Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.|Baseline to the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
138695|NCT00481676|Secondary|Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study|Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.|At the end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Participants|||Number
138696|NCT00481676|Primary|Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.|Baseline to end of the study (Week 24)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment of the primary efficacy variable.||Units on a scale||Standard Deviation|Mean
147686|NCT00407537|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHG||95% Confidence Interval|Least Squares Mean
138699|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|Safety analysis set.||Participants|||Number
138700|NCT00480636|Secondary|Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood|Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.|Baseline through Month 6 or EOT (up to Month 6)|The safety analysis set was defined as all participants who received at least 1 dose of study treatment.||Participants|||Number
138701|NCT00480636|Primary|Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg|Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg|Month 6 or End of Treatment (EOT) (up to Month 6)|Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement.||Participants|||Number
138702|NCT00481507|Secondary|Absences From Daycare or School Owing to Illness, Missed Parental Work Owing to the Child Being Ill, Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools.||14 days||||||
138703|NCT00481507|Primary|Rate of Diarrhea by Parental Report|The primary outcome was the rate of diarrhea during the 14-day follow-up period in children receiving antibiotics.|14 days|Prior estimates of the sample size showed that 62 per group would have 80% power for detecting a difference of 20% in the rates of diarrhea. This was based on the placebo group having a 10% (which is consistent with published literature) rate of diarrhea. Analysis performed used the intention to treat and no imputation was required.||events/participants at risk|||Number
138704|NCT00481351|Secondary|High Density Lipoprotein||12 week|||mg/dl||Standard Deviation|Mean
138705|NCT00481351|Secondary|Total Cholesterol||12 week|||mg/dl||Standard Deviation|Mean
138706|NCT00481351|Secondary|CPK||12 week|||mg/dl||Standard Deviation|Mean
138707|NCT00481351|Secondary|Alanine Aminotransferase||12 weeks|||mg/dl||Standard Deviation|Mean
138708|NCT00481351|Primary|Low Density Lipoprotein||12week|||mg/dl||Standard Deviation|Mean
138709|NCT00481351|Secondary|Triglyceride Fractional Clearance Rate||6week||11/2010||||
138710|NCT00481351|Primary|Cholesteryl Ester Fractional Clearance Rate||6 weeks||07/2011||||
138711|NCT00481247|Other Pre-specified|Number of Participants With Grade 3/4 Abnormalities in On-study Laboratory Test Results|ULN=upper limit of normal. Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE. Absolute neutrophil count: Grade 3 <1000-500/mm^3; Grade 4 <500/mm^3. Hemoglobin: Grade 3 <8.0-6.5 g/dL; Grade 4 <6.5 g/dL. Platelets: Grade 3 <50,000-25,000/mm^3; Grade 4 <25,000/mm^3. ALT/AST: Grade 3 >5.0-20*ULN; Grade 4 >20*ULN. Total bilirubin: Grade 3 >3-10*ULN; Grade 4 >10*ULN. Sample normal ranges (may vary by institution): ALT, Female: 7-30 U/L, Male: 10-55 U/L; AST, Female: 9-25 U/L, Male10-40 U/L; Total bilirubin: 0.0-1.0 mg/dL. Creatinine: Grade 3 >3.0–6.0*ULN; Grade 4 >6.0*ULN. Phosphate: Grade 3 <2.0–1.0 mg/dL; Grade 4 <1.0 mg/dL. Calcium: Grade 3 <7.0–6.0 mg/dL; Grade 4 <6.0 mg/dL. Potassium: Grade 3 <3.0–2.5 mmol/L; Grade 4 <2.5 mmol/L.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|Participants with laboratory assessments||Participants|||Number
138712|NCT00481247|Other Pre-specified|Number of Participants With Adverse Events (AEs), Drug-related AEs, Drug-related Serious Adverse Events (SAEs), Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From date of last person, first visit to date of last person, last visit (approximately 8 years)|All treated participants||Participants|||Number
138713|NCT00481247|Secondary|Percentage of Participants With Overall Survival (OS)|OS was defined as the time from randomization to the date of death. If the participant had not died, survival was censored on last date the participant was known to be alive.|Participants were followed-up for at least 5 years|All randomized participants||Percentage of participants|||Number
138714|NCT00481247|Secondary|Percentage of Participants With Progression-free Survival (PFS)|PFS was defined as the time from randomization until progression (any progression/death within 30 days of last dosing date, or between 30-60 days of last dosing prior to start of secondary therapy). Those who did not progress/die or who progressed/died after 60 days of last dose were censored at last on-study hematologic/cytogenetic assessment; those with progression/death 30-60 days of last dosing date and after start date of secondary therapy censored at last on-study hematologic/cytogenetic assessment prior to start of secondary therapy; those who had not received study treatment censored on date randomized.|Participants were followed-up for at least 5 years|All randomized participants||Percentage of participants|||Number
138715|NCT00481247|Secondary|Time to Major Molecular Response (MMR) Overall|The time to MMR for all randomized participants is defined as the time from randomization date until measurement criteria are first met for MMR. The time to MMR analysis censors nonresponders who do not progress at their last molecular assessments and nonresponders who progress at the maximum time of all randomized participants.|Day 1 to 5 years|All participants who received treatment and achieved MMR||Months||95% Confidence Interval|Median
138716|NCT00481247|Secondary|Time to Confirmed Complete Cytogenic Response (cCCyR) Overall|The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants.|Day 1 to 5 years|All randomized participants who achieved cCCyR||Months||95% Confidence Interval|Median
138717|NCT00481247|Secondary|Percentage of Participants With Major Molecular Response (MMR) at Any Time|Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).|Planned total follow-up duration of 5 years|All randomized participants||Percentage of participants|||Number
138718|NCT00481247|Secondary|Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.~Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1."|Years 2, 3, 4 and 5|All randomized participants who achieved cCCyR||percentage of participants||95% Confidence Interval|Number
138719|NCT00481247|Primary|Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.|Pretreatment, every 3 months up to 12 months|All randomized participants||Participants|||Number
138720|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 8|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 8 are presented."|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at week 8||Participants|||Number
138721|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 6|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 6 are presented."|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at Week 6||Participants|||Number
138722|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 4|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 4 are presented."|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with CGI-BP at baseline and at 4 weeks||Participants|||Number
138723|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 3|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 3 are presented."|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and at 3 weeks||Participants|||Number
138724|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 2|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 2 are presented."|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at baseline and week 2||Participants|||Number
138733|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
138725|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Week 1|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 1 are presented."|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed by CGI-BP at Baseline and Week 1||Participants|||Number
138726|NCT00481195|Secondary|The Number of Responders According to the Clinical Global Impression of Change – Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)|"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Endpoint are presented."|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed by CGI-BP at Baseline and at least one observation after Baseline.||Participants|||Number
138727|NCT00481195|Secondary|Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
138728|NCT00481195|Secondary|Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the HAM-A at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
138729|NCT00481195|Secondary|Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline).|baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the HAM-A at baseline and at least once after baseline||Units on a scale||Standard Error|Least Squares Mean
138730|NCT00481195|Secondary|Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who completed questionnaire at baseline and at 8 weeks||Units on a scale||Standard Error|Least Squares Mean
138731|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the questionnaire at baseline and at 4 weeks.||Units on a scale||Standard Error|Least Squares Mean
138732|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the questionnaire at baseline and at any appropriate time point after baseline||Units on a scale||Standard Error|Least Squares Mean
138796|NCT00480324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
138734|NCT00481195|Secondary|Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 6 weeks||Units on a scale||Standard Error|Least Squares Mean
138735|NCT00481195|Secondary|Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
138736|NCT00481195|Secondary|Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at week 3||Units on a scale||Standard Error|Least Squares Mean
138737|NCT00481195|Secondary|Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
138738|NCT00481195|Secondary|Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at 1 week||Units on a scale||Standard Error|Least Squares Mean
138739|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)|The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline).|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who completed the QIDS-SR16 at baseline and at least one observation after baseline.||Units on a scale||Standard Error|Least Squares Mean
138740|NCT00481195|Secondary|Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 8||Units on a scale||Standard Error|Least Squares Mean
138741|NCT00481195|Secondary|Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by MADRS at both baseline and at Week 4||Units on a scale||Standard Error|Least Squares Mean
138758|NCT00481195|Secondary|The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30.|Baseline and 1 week following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at week 1 after start of study drug administration||Units on a scale||Standard Error|Least Squares Mean
138742|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint.|Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)|Full analysis set defined as subjects who had both a baseline observation and at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
138743|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
138744|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at week 4||Units on a scale||Standard Error|Least Squares Mean
138745|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects assessed with IDS-C30 at baseline and at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
138746|NCT00481195|Secondary|Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with IDS-C30 at baseline and at week 8||Units on a scale||Standard Error|Least Squares Mean
138747|NCT00481195|Secondary|Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed by IDS C30 at baseline and Week 4||Units on a scale||Standard Error|Least Squares Mean
138748|NCT00481195|Secondary|Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia.|Baseline and 8 weeks (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline and at least one observation after baseline||Units on a scale||Standard Error|Least Squares Mean
138773|NCT00481065|Primary|Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine|"Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH).~Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
138749|NCT00481195|Secondary|"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained response (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline||Participants|||Number
138750|NCT00481195|Secondary|"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained remission (total score <= 11 that persists over the four week period from Week 4 to Week 8)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline||Participants|||Number
138751|NCT00481195|Secondary|"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"|"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a response (> 50% decrease from baseline in total score)."|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed by IDS-C30 at baseline, and at least one observation after baseline||Participants|||Number
138752|NCT00481195|Secondary|Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11).|Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who had completed IDS-C30 at baseline and at least one observation after baseline||Participants|||Number
138753|NCT00481195|Secondary|The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30.|Baseline and 8 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed at baseline and at 8 weeks with the IDS-C30.||Units on a scale||Standard Error|Least Squares Mean
138754|NCT00481195|Secondary|The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30.|Baseline and 6 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 6 weeks||Units on a scale||Standard Error|Least Squares Mean
138755|NCT00481195|Secondary|The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30.|Baseline and 4 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 4 weeks||Units on a scale||Standard Error|Least Squares Mean
138756|NCT00481195|Secondary|The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30.|Baseline and 3 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 3 weeks||Units on a scale||Standard Error|Least Squares Mean
138757|NCT00481195|Secondary|The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30.|Baseline and 2 weeks following the start of study drug administration|Full analysis set defined as subjects who were assessed with the IDS-C30 at baseline and at 2 weeks||Units on a scale||Standard Error|Least Squares Mean
138759|NCT00481195|Primary|The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)|The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient’s depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.|Baseline and 8 weeks from start of study drug administration (or last observation after baseline)|Full analysis set defined as subjects who were assessed with the IDS-C30 at both baseline and at least one time point after baseline||Units on a scale||Standard Error|Least Squares Mean
138760|NCT00481078|Secondary|Overall Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year|||Months||95% Confidence Interval|Median
138761|NCT00481078|Secondary|Progression-free Survival|Evaluated using the Kaplan-Meier method. Compared between arms using the log-rank test.|Up to 1 year|||Months||95% Confidence Interval|Median
138762|NCT00481078|Primary|Response Rate|"Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).~Patients with confirmed CR or PR according to the RECIST criteria were considered to have responded to treatment."|Assessed every two cycles|||percentage of responding patients||95% Confidence Interval|Number
138763|NCT00481065|Secondary|Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.|21 days after booster vaccination (day 403)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
138764|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
138765|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second and third vaccinations (day 43 and day 403)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
138766|NCT00481065|Secondary|Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine|"Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.~The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382."|21 days after booster vaccination (day 403)|Full analysis set (FAS)||Subjects|||Number
138767|NCT00481065|Primary|Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)|For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.|21 days after second vaccination (day 43)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
138768|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
138769|NCT00481065|Primary|Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)|"seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second and third vaccinations (day 43 and day 403)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
138770|NCT00481065|Primary|Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)|"seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.~Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2."|21 days after second vaccination (day 43)|The analysis was done on the full analysis set (FAS).||Subjects|||Number
138771|NCT00481065|Secondary|Number of Subjects Reporting Local and Systemic Reactions by Vaccination|The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.|21 days after second and third vaccinations (day 43 and day 403)|||Subjects|||Number
138772|NCT00481065|Primary|Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine|Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.|21 days after second and third vaccinations (day 22 and day 43)|Full analysis set (FAS)||Ratio||95% Confidence Interval|Geometric Mean
138793|NCT00480493|Primary|Worry|Parent worry in managing child's care. Higher total scores (11 questions, minimum score is 11, maximum score is 44) indicate more parental worry|12 months|||units on a scale||Standard Deviation|Mean
138794|NCT00480493|Primary|Parent Concern|Parent concern in managing child with type 1 diabetes. Higher total scores (58 questions, minimum score is 58; maximum score is 255) means more worry with managing child's diabetes care.|12 months|||units on a scale||Standard Deviation|Mean
138774|NCT00480987|Primary|Number of Participants With Objective Response|Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/Liters or more and platelet count of 100*10^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100*10^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts >/= 50% and not more than 6-25% abnormal cells in the marrow.|After 2 months|Analysis was per protocol. All participants treated were analyzed.||Participants|||Number
138775|NCT00480857|Secondary|To Determine the Rates of Local Recurrence-free Survival, Distant Metastasis- Free Survival, Disease-specific Survival and Overall Survival|To determine the rates of local recurrence-free survival, distant metastasis-free survival, disease-specific survival and overall survival after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.|4 years||||||
138776|NCT00480857|Secondary|To Determine the Rates of Acute and Late Toxicities|To determine the rates of acute and late toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.|4 years||||||
138777|NCT00480857|Secondary|Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less|To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.|4 years|||patients|||Number
138778|NCT00480857|Primary|Percentage of Patients Alive Without Progression at 4 Years|The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.|4 years|||percentage of patients||95% Confidence Interval|Number
138779|NCT00480779|Secondary|Change in Triglycerides|A secondary outcome for this study will be change in Triglyceride level, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Inter-Quartile Range|Median
138780|NCT00480779|Secondary|Change in Diastolic Blood Pressure|A secondary outcome for this study will be change in diastolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mmHg||Standard Deviation|Mean
138781|NCT00480779|Secondary|Change in Systolic Blood Pressure|A secondary outcome for this study will be change in systolic blood pressure, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mmHg||Standard Deviation|Mean
138782|NCT00480779|Secondary|Change in Hemoglobin A1C|A secondary outcome for this study will be change in HbA1c, measured pre and post intervention. The hemoglobin HbA1c test provides information regarding how well blood glucose (sugar) has been controlled for the previous 8-12 weeks..|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||percentage of glycosylated hemoglobin||Standard Deviation|Mean
138783|NCT00480779|Secondary|Change in Fasting Glucose|A secondary outcome for this study will be change in fasting glucose, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
138784|NCT00480779|Secondary|Change in LDL Cholesterol|A secondary outcome for this study will be change in LDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
138785|NCT00480779|Secondary|Change in HDL Cholesterol|A secondary outcome for this study will be change in HDL cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
138786|NCT00480779|Secondary|Change in Total Cholesterol|A secondary outcome for this study will be change in total cholesterol, measured pre and post intervention.|Baseline and 3 months|Intent to treat. Participants with relevant medication changes between baseline and 3 months were excluded.||mg/dl||Standard Deviation|Mean
138787|NCT00480779|Secondary|Change in Waist Circumference|A secondary outcome for this study will be change in waist circumference, measured pre and post intervention.|Baseline and 3 months|Intent to treat||inches||Standard Deviation|Mean
138788|NCT00480779|Primary|Change in Weight|The primary outcome for this study will be change in weight measured pre and post intervention.|Baseline and 3 months|Intent to treat using Last Observation Carried Forward (LOCF)||pounds||Standard Deviation|Mean
138789|NCT00480740|Primary|Changes in Hemodynamic Variables Recorded During Administration of Sevoflurane + Dexmedetomidine.|"Non-inferiority was shown when differences at steady-state (dexmedetomidine + sevoflurane) compared to baseline (sevoflurane alone) and its associated 95% confidence interval fell completely within the range of plus or minus 20%.The 95% confidence interval was normalized by subtracting the baseline values.~Bispectral Index: monitors electroencephalographic and electromyographic parameters to monitor the depth of anesthesia."|Up to 24 hours following cardiac catheterization|||percentage of change from baseline||95% Confidence Interval|Mean
138790|NCT00480532|Secondary|Subject Compliance|measured by self report of pill intake on daily diary (yes/no), and reported as percentage with no missed pills over entire study|Assessed on day 112 of the study (the end of the study period). The outcome reflects the number of subjects who did not miss pills during the entire 112 day study. It does not represent a change from baseline.|||number of participants with no missed pi|||Number
138791|NCT00480532|Secondary|Subject Satisfaction.|"measured using 100 mm visual analog scale. anchors of not at all satisfied (0mm) extremely satisfied (100mm)"|Assessed on day 112 of the study (the end of the study period). This outcome does not represent a change from baseline. It was assessed at the end of the study period.|||mm||Standard Deviation|Mean
138792|NCT00480532|Primary|Differences in Bleeding Patterns Between Study Groups.|number of days of bleeding and spotting, self reported on calendar|The outcome was also assessed for day 1 to 84|All participants analyzed in the groups to which they were randomized except for 1 subject in prevention placebo group who was erroneously enrolled although she did not meet enrollment entry criteria||days||Standard Error|Mean
138797|NCT00480324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
138798|NCT00480324|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.|During the 8-day follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
138799|NCT00480324|Secondary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.||subjects|||Number
138800|NCT00480324|Secondary|Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration|Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).|2 months after Dose 2|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
138801|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From Dose 1 up to 2 years of age|The analysis was performed on the Total Vaccinated cohort.||subjects|||Number
138802|NCT00480324|Secondary|Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
138803|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
138804|NCT00480324|Secondary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type|"Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.~Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system)."|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
138805|NCT00480324|Secondary|Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
138806|NCT00480324|Primary|Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains|Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.|From 2 weeks after Dose 2 up to 2 years of age|The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.||subjects|||Number
138807|NCT00479882|Secondary|Percentage Change From Baseline in HDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
138808|NCT00479882|Secondary|Percentage Change From Baseline in LDL-C at Week 4|Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.|Baseline (Day1 of Period I) and Week 4|Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
147687|NCT00407537|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Month 4||Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHG||95% Confidence Interval|Least Squares Mean
138809|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Non-serious Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138810|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138811|NCT00479882|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined, where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). Excludes 6 participants who had an AE that began during the placebo run-in.||Percentage of Participants|||Number
138812|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138813|NCT00479882|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138814|NCT00479882|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138815|NCT00479882|Secondary|Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline|Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants with diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138998|NCT00477269|Secondary|Blood Gas Measurement - PaO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
138816|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138817|NCT00479882|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became ‘impaired’ during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who had normal fasting blood glucose levels at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138818|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138819|NCT00479882|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138820|NCT00479882|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138821|NCT00479882|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).||Percentage of Participants|||Number
138822|NCT00479882|Secondary|Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
138823|NCT00479882|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.||Percentage Change||95% Confidence Interval|Least Squares Mean
138824|NCT00479856|Secondary|Number of Participants With the Indicated Serious Adverse Events and Adverse Events|Qualitative and quantitative toxicities associated with the combination of capecitabine, docetaxel, or nab-paclitaxel and lapatinib were measured. Data are presented as serious adverse events (SAEs) and adverse events (AEs). See the SAE/AE section of the results record for data.|Baseline through End of Treatment, or discontinuation of study therapy (approximately 95 weeks); from the first dose of lapatinib until 5 days after the last dose of lapatinib|||participants|||Number
138825|NCT00479856|Secondary|Progression-free Survival|The time from the start of treatment until the earliest date of disease progression or death due to any cause was measured.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks); dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint of overall response rate was evaluated.||weeks||95% Confidence Interval|Median
138826|NCT00479856|Secondary|Time to Response (TTR)|TTR is defined as the time from the start of treatment until the first documented evidence of PR or CR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the TTR was taken to be the first time that the response was observed.|start of treatment until first documented evidence of CR or PR (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.||weeks||95% Confidence Interval|Median
138827|NCT00479856|Secondary|Duration of Response|For the subset of participants with a confirmed CR or PR, duration of response was measured as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|time from first documented evidence of CR or PR until the first documented sign of disease progression or death (approximately 95 weeks)|Due to the low incidence of relapse and hence the difficulty in identifying eligible participants, the study was terminated with only 9 out of the 45 planned participants enrolled. As there were too few participants to derive statistically meaningful conclusions, only the primary endpoint was evaluated.||weeks||95% Confidence Interval|Median
138828|NCT00479856|Secondary|Clinical Benefit (CB)|CB is defined as the percentage of participants (par.) with either a confirmed CR or PR or stable disease (SD) for at least 24 weeks. SD is defined as small changes that do not meet criteria for CR, PR, or Progressive Disease (defined as at least a 20% increase in the sum of the longest diameter of target lesions).|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 weeks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, or other reason)|Due to the low incidence of relapse and hence the difficulty in identifying eligible par., the study was terminated with only 9 out of the 45 planned par. enrolled. As there were too few par. to derive statistically meaningful conclusions, only the primary endpoint was evaluated.||percentage of participants|||Number
138829|NCT00479856|Primary|Overall Tumor Response|Overall tumor response is defined as the percentage of participants with a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as the disappearance of all target lesions. CR could only be declared if all target and non-target lesions had disappeared. Partial response (PR) is defined as a decrease of 30% or greater in the sum of the longest diameter of target lesions.|from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment||percentage of participants|||Number
138830|NCT00479765|Primary|Occurence of Dose-limiting Toxicities (DLTs)|any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)|8 weeks|||dose limiting toxicities|||Number
138831|NCT00479713|Other Pre-specified|Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein|Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Median
138832|NCT00479713|Other Pre-specified|Percent Change From Baseline in Apolipoprotein B|Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
138833|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
138834|NCT00479713|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio|Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
147688|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 12||Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||mmHg||Standard Deviation|Mean
138835|NCT00479713|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)|Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
138836|NCT00479713|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
138837|NCT00479713|Other Pre-specified|Percent Change From Baseline in Triglycerides.|Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Median
138838|NCT00479713|Other Pre-specified|Percent Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
138839|NCT00479713|Secondary|The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment|"The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment.~The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group."|after 6 weeks of treatment|Full Analysis Set (FAS)||Percent of participant population|||Number
138840|NCT00479713|Primary|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment|Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.||percent change from baseline||95% Confidence Interval|Least Squares Mean
138841|NCT00479674|Secondary|to Determine if SPARC Expression in Breast Tumors Predicts Progression-free Survival (PFS)||18 months|Study plan stipulated that tissue samples would not be assessed for quantitatively if no difference in SPARC expression was observed between tumor and non-tumor cells was observed qualitatively.|||||
138842|NCT00479674|Secondary|to Determine if Apolipoprotein Alleles (Apo-E) Correlate With Treatment-related Neuropathy||18 months|Samples were collected, but analysis was not performed as there was inadequate funding to support the testing and analysis of samples.|||||
138843|NCT00479674|Secondary|To Evaluate Sequential Plasma Samples for Presence of Selected Angiogenic Markers||18 months|Analysis of samples was not performed, as there was inadequate funding to support the testing and analysis of the samples.|||||
138844|NCT00479674|Secondary|Median Proportion Progression-free as Estimated by Kaplan-Meier Methods|PFS was defined as time from trial enrollment to disease progression or death, whichever occurred first.|5 years|One subject lost to follow up and not included in analysis.||months||95% Confidence Interval|Median
138845|NCT00479674|Primary|"Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III Triple Negative Metastatic Breast Cancer."|Best clinical response is based on RECIST criteria, the proportion in each response category along with the exact binomial confidence intervals are estimated. Toxicity summaries are also provided.|5 years|2 subjects withdrew and were not assessed for response||percentage of participants||95% Confidence Interval|Number
138846|NCT00479557|Secondary|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)|IgG subtypes were not assessed|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104||||||
138847|NCT00479557|Secondary|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
138848|NCT00479557|Secondary|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.||U/mL||95% Confidence Interval|Geometric Mean
139122|NCT00476645|Primary|PSA Reduction ≥ 50%|Number of subjects with serum PSA reduction ≥ 50% at 3 months|3 months|All subjects (10 males) had castration-resistant prostate cancer. 6 had recieved prior radical prostatectomy as primary therapy. 4 had received prior chemotherapy. The majority had previously received 2 hormonal therapies. 2 had recieved radiation therapy, and 2 had recieved hormonal monotherapy.||participants|||Number
138849|NCT00479557|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.|The safety population included all randomized participants with documented use of at least one dose of study drug.||percentage of participants|||Number
138850|NCT00479466|Secondary|Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
138851|NCT00479466|Secondary|Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
138852|NCT00479466|Primary|Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)||Week 12|All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
138853|NCT00479401|Secondary|Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events||baseline and after 33 weeks of treatment|Treated set (TS)||participants|||Number
138854|NCT00479401|Secondary|Possible Clinically Significant Abnormal Laboratory Parameters|The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.|baseline and after 33 weeks of treatment|Treated Set Labs (TSLabs), all patients in TS with a clinical laboratory measurements at baseline and at the last visit.||participants|||Number
138855|NCT00479401|Secondary|Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)|mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).|from trial start on to any time before final assessment of the patient, up to 33 weeks|Treated Set (TS), all randomized patients, who were dispensed study medication and documented to have taken at least 1 dose of study medication.||patients|||Number
138856|NCT00479401|Secondary|Patients Who Started to Use L-Dopa Rescue Medication|L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population|from trial start on to any time before final assessment of the patient, up to 33 weeks|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||patients|||Number
138857|NCT00479401|Secondary|Change From Baseline in European Quality of Life Visual Analog Scale|European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
138858|NCT00479401|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include:~mobility (e.g. fear of falling when walking): 10 items~activities of daily living (e.g. difficulty cutting food): 6 items~emotional well-being (e.g. feelings of isolation): 6 items~stigma (e.g. social embarrassment): 4 items~social support: 3 items~cognition: 4 items~communication: 3 items~bodily discomfort: 3 items.~A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement."|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
138859|NCT00479401|Secondary|Parkinson's Disease Sleep Scale (PDSS)|PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
138860|NCT00479401|Secondary|Likert Scale for Pain Related to PD|Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
139123|NCT00476593|Primary|Macular Thickness Measured With the OCT; in Relation to Age, Sex, Reproductive Factors and the Use of Anti-inflammatory Eye Drops in Health; in Uncomplicated Anterior Uveitis.|Macular thickness was assessed with the OCT in healthy subjects and in patients with anterior uveitis. Data was analyzed with respect to age, sex, parity, the use of hormonal therapy, after treatment with to types of anti-inflammatory eye drops, and in uncomplicated uveitis.|Macular thickness measured with the OCT|Enrolled healthy subjects and patients with anterior uveitis who volunteered through enrollment period||Macular Thickness in micron||Standard Deviation|Mean
138861|NCT00479401|Secondary|Beck's Depression Inventory Version I A|The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
138862|NCT00479401|Secondary|UPDRS Part III Total Score|UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
138863|NCT00479401|Secondary|UPDRS Part II Total Score|UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Mean
138864|NCT00479401|Secondary|UPDRS Part I Change From Baseline|UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement|baseline and after 33 weeks treatment|Full Analysis Set with (LOCF), all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||Inter-Quartile Range|Median
138865|NCT00479401|Secondary|UPDRS II+III Responder Rate (at Least 20% Improvement)|Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.|after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||percentage of responders|||Number
138866|NCT00479401|Secondary|Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale|Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. Responders are the patients with 'much better' and 'very much better' on the score.|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008||Percentage of Participants|||Number
138867|NCT00479401|Secondary|Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale|Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale|after 18 weeks of treatment compared to baseline|Full Analysis Set 1, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment and completed 18 weeks of treatment or discontinued prematurely at the interim cut off date Apr 2008||Percentage of Participants|||Number
138868|NCT00479401|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score|Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.|baseline and after 33 weeks treatment|Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment||units on a scale||95% Confidence Interval|Least Squares Mean
138869|NCT00479388|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and 12 Weeks|Full Analysis Set With at Least one Post-Titration Visit Measurement||Percent||95% Confidence Interval|Median
138870|NCT00479388|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set||Percent||95% Confidence Interval|Least Squares Mean
138871|NCT00479388|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12||Baseline and 12 Weeks|Full Analysis Set||Percent||95% Confidence Interval|Least Squares Mean
138872|NCT00479336|Secondary|Abdominal Circumference|Change in abdominal circumference from baseline (LOCF)|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF||cm||Standard Deviation|Mean
138873|NCT00479336|Primary|Body Weight (Amount of Change)|Changes in body wight from baseline at the final timepoint (LOCF). A linear regression model using changes in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset.|Baseline, Day 7 or at the discontied of treatment|Full Analysis Set; LOCF||Kg||Standard Deviation|Mean
138874|NCT00479258|Secondary|7 Point Home Glucose||12 months||||||
138875|NCT00479258|Secondary|Hypoglycemic Event Rates;||12 months||||||
138876|NCT00479258|Secondary|Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;||12 months||||||
138877|NCT00479258|Secondary|Change From Baseline in Insulin Antibodies (microU/mL);||12 months||||||
138878|NCT00479258|Secondary|Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c||12 months||||||
138879|NCT00479258|Secondary|Slope for Other PFT Parameters;||12 months||||||
138880|NCT00479258|Secondary|Change From Baseline in FVC||12 months||||||
138881|NCT00479258|Secondary|Treatment Preferences.||12 months||||||
138882|NCT00479258|Secondary|Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;||12 months||||||
138883|NCT00479258|Secondary|Change From Baseline in Other PFT Parameters||12 months||||||
138884|NCT00479258|Primary|To Assess Pulmonary Safety and Glycemic Control of Exubera Over a 12 Month Controlled Period|No subjects were dosed therefore no data collected.|12 months|No subjects were dosed therefore no participants for analysis.||no data|||Number
147689|NCT00407537|Secondary|Mean Systolic and Diastolic Blood Pressure at Month 4||Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||mmHg||Standard Deviation|Mean
138885|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Intermediate-high Risk Myelodysplastic Syndrome (MDS) or Untreated Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with intermediate-high risk MDS or untreated AML who were treated with vorinostat and decitabine either on a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for MDS participants.|Approximately 6 months|||percentage of participants|||Number
138886|NCT00479232|Other Pre-specified|Objective Response Rate in Participants Treated With Vorinostat + Decitabine With Refractory or Relapse Acute Myelogenous Leukemia (AML)|Objective Response Rate was measured in participants with refractory or relapse AML (acute myelogenous leukemia) in combination with Decitabine who were treated with vorinostat and decitabine on either a concurrent or sequential regimen. The Objective response was defined as any confirmed complete remission or any confirmed partial remission for AML participants and complete remission, confirmed partial remission or confirmed hematologic improvement for Myelodysplastic Syndrome (MDS) participants.|Approximately 6 months|||percentage of participants|||Number
138887|NCT00479232|Primary|Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events|Participants who received at least one dose of vorinostat in combination with decitabine intravenous (IV) at a dose of 20 mg/m^2 daily for 5 days along with oral vorinostat 400 mg once daily for 7 to 14 days in a 28-day cycle concurrently or sequentially, were evaluated to determine the maximum tolerable dose (MTD) determined by the number of participants experiencing dose limiting toxicity (DLT) events defined as any Grade 3 or 4 non-hematological toxicity (reported adverse event) and/or myelosuppression lasting >42 days.|Day 1 to 28 of Cycle 1|||participants|||Number
138888|NCT00479154|Primary|Change in Restless Legs Syndrome Rating Scale|Primary outcome measure will be the mean change from baseline in RLS scale at week 2 following placebo/BTX injections. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40).|Week 2 and Week 4 for each intervention (vs. baseline)|||RLS Rating Score||Standard Deviation|Mean
138889|NCT00479089|Secondary|Median Progression Free Survival From Trial Enrollment for Overall Study|Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|From trial enrollment to disease progression or death, up to five years|Analysis by intent to treat population with all participants treated included.||Months||Full Range|Median
138890|NCT00479089|Secondary|Median Overall Survival|Overall survival was summarized using the Kaplan-Meier estimation.|Baseline till participant death or end of follow-up period, assessed every 4 weeks, up to 5 years.|Analysis by intent to treat population with all participants treated included.||Months||Full Range|Median
138891|NCT00479089|Primary|Number of Participants Free From Progression 9 Months From Start of Consolidation Therapy|The proportion of participants’ progression free at 9 months compared between treatments using chi-square. Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.|Assessment at 9 Months of therapy|In order to test the trial hypotheses for the two cohorts progression at nine months, a sample size of 45 participants for each arm was required. Accrual was not met to assess the outcome hypotheses thus no participant analysis available.|||||
138892|NCT00479037|Secondary|Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial|"CTX is a marker of bone resorption, which is a degradation product of bone collagen.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||percent change||Standard Deviation|Mean
138893|NCT00479037|Primary|Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial|"BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||percent change||Standard Deviation|Mean
138894|NCT00479037|Primary|Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial|"P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen.~Bone marker measurements were done by blood analysis."|Baseline and 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||percent change||Standard Deviation|Mean
138895|NCT00478881|Secondary|Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks|The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life. It comprises 33 items (6-point scale for each item). The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms). On each item, participants provide their rating over the past 4 weeks. Missing data were imputed by LOCF.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||scores on a scale||Standard Error|Least Squares Mean
138896|NCT00478881|Secondary|Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older|Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|mITT: Participants who received at least one dose, randomized correctly according to Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. Qmax is based on men predominantly aged 50 years and older but includes a few males who had Qmax collected even if younger than 50 years.||milliliter per second (mL/s)||Standard Error|Least Squares Mean
138897|NCT00478881|Secondary|Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks|The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||involuntary discharges per day||Standard Error|Least Squares Mean
138898|NCT00478881|Secondary|Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks|The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary. Missing data were imputed by last observation carried forward.|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||urgencies per day||Standard Error|Least Squares Mean
138899|NCT00478881|Secondary|Change From Baseline in Volume at First Desire to Void at 6 Weeks|Volume at first desire to void was recorded during urodynamic assessments. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
138900|NCT00478881|Secondary|Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks|Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
138901|NCT00478881|Secondary|Change From Baseline in Volume at First Detectable Leakage at 6 Weeks|First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure. Missing data was imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
138902|NCT00478881|Secondary|Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks|Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks. Missing data were imputed by last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Modified intent-to-treat (mITT) population: participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
138903|NCT00478881|Primary|Change From Baseline in Average Number of Daily Micturitions at 6 Weeks|Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment LOCF|"Intent-to-treat (ITT) population: all randomized participants with at least one study drug medication were to be included provided they had a baseline measurement (if scheduled) and a follow-up measurement in any clinical variable. The number is not identical to participants who completed."||micturitions per day||Standard Error|Least Squares Mean
138904|NCT00478881|Primary|Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks|Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks. Missing data were imputed with last observation carried forward (LOCF).|baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)|"Modified intention-to-treat (mITT): participants included in the safety sample (received at least one dose), randomized correctly according to the Urodynamic Adjudication Board (UDAB), having one valid baseline and one valid (UDAB) on treatment urodynamic measurement. The number is not identical to participants who completed the study."||mL||Standard Error|Least Squares Mean
138905|NCT00478777|Secondary|Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria|Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.|up to 827 days|Values for the free light chain concentrations were determined to be invalid.||Days||Standard Deviation|Mean
138906|NCT00478777|Secondary|Participants With Treatment-emergent Adverse Experiences (TEAEs)|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.~National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 8 months|Safety population||participants|||Number
138907|NCT00478777|Secondary|Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria|"Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD).~CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline."|Up to 827 days|Full analysis set||participants|||Number
138908|NCT00478777|Primary|Kaplan Meier Estimate for Time to Disease Progression|"Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease.~Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 827 days|Full analysis dataset||days||95% Confidence Interval|Median
138909|NCT00478673|Primary|Number of Participants Who Experienced a 12-Month Major Adverse Event (MAE)|12-month major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure (see 30-Day MAE above), and ipsilateral stroke events that occur within 31-365 days post-procedure.|12 Months|ITT Analysis: All enrolled subjects who experienced a 12-mo MAE and/or completed a follow-up evaluation >=335 days post-procedure were evaluable. Subjects who experienced more than one MAE within 12 months were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 12-mo MAE.||Participants|||Number
138910|NCT00478673|Primary|Number of Participants Who Experienced a 30-Day Major Adverse Event (MAE)|30-day major adverse events (MAEs) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.|30 Days|ITT Analysis: All enrolled subjects who experienced a 30-day MAE and/or completed a follow-up evaluation >=23 days post-procedure were evaluable. Subjects who experienced more than one MAE within 30 days were counted in the number of subjects with each applicable event, but were only counted once in the number of subjects with overall 30-day MAE.||Participants|||Number
138911|NCT00478647|Primary|Participants Who Experienced at Least One Adverse Event|"Safety was assessed throughout the study by assessments including adverse events, concomitant medication use, and vital signs. Additional safety assessments, including 12-lead ECGs, physical examinations, clinical laboratory tests and determination of the presence of anti-velaglucerase alfa antibodies.~Refer to Adverse event section for further details."|Week 53|Safety population included subjects who have received at least 1 full or partial dose of study drug.||participants|||Number
138912|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Spleen Volume|Spleen volume has been normalized for percentage (%) of body weight. Spleen size relative to body weight= (Spleen volume [cc]/Body weight [kg])*100|Week 51|ITT population. Four splenectomized participants were excluded.||Percent (%) change||90% Confidence Interval|Mean
138913|NCT00478647|Secondary|Percent Change From Baseline to Week 51 in Normalized Liver Volume|Liver volume has been normalized for percentage (%) of body weight. Liver size relative to body weight= (Liver volume [cc]/Body weight [kg])*100|Week 51|ITT population.||Percent (%) change||90% Confidence Interval|Mean
138914|NCT00478647|Secondary|Percent Change From Baseline to Week 53 in Platelet Count||Week 53|ITT population.||percent (%) change||90% Confidence Interval|Mean
138915|NCT00478647|Secondary|Change From Baseline to Week 53 in Hemoglobin Concentration||Week 53|ITT population.||g/dL||90% Confidence Interval|Mean
138916|NCT00478608|Secondary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|12 months after transplantation|Patients who received at least one dosing of SRL after transplantation.||patients|||Number
138917|NCT00478608|Secondary|Patient and Graft Survival|Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|12 months|Patients who received at least one dosing of SRL after transplantation.||patients|||Number
138918|NCT00478608|Secondary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Baseline, 6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values||mg/dl||Standard Deviation|Mean
138919|NCT00478608|Secondary|Glomerular Filtration Rate (GFR) (Nankivell Method)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.|6 and 12 months|Patients who received at least one dose of SRL after transplantation. Observed values||mL/min||Standard Deviation|Mean
138920|NCT00478608|Primary|Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.|The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).|6 months after transplantation|Patients who received at least one dosing of SRL after transplantation.||patients|||Number
138921|NCT00478569|Secondary|Treatment Compliance by Visit|"A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician’s advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.~Data on compliance were obtained at each visit and relate to the period since the previous recorded visit."|From enrollment to 3, 6, 12, 18, and 24 months|||participants|||Number
138922|NCT00478569|Secondary|Duration of Treatment|Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.|24 months|Participants for whom data were available||months||Full Range|Mean
138923|NCT00478569|Secondary|Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment|A participant was defined as “permanently discontinued” if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as “temporarily discontinued” if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still “ongoing” during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as “missing” or “unknown” if they attended the relevant visit and there was no result or “unknown” was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.|From enrollment to 3, 12, 18, and 24 months|All enrolled participants||participants|||Number
138924|NCT00478569|Primary|Number of Participants Who Discontinued Before 6 Months of Treatment|"A participant was defined as permanently discontinued if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards."|6 months|All enrolled participants||participants|||Number
138925|NCT00478556|Secondary|Bowel Opacification Score|The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.|Collected day of study|per protocol - all patients had usable data||arbitrary score||Standard Deviation|Mean
138926|NCT00478556|Primary|Preferred Contrast Agent|The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.|1 Day|Analysis was per protocol||participants|||Number
138927|NCT00478257|Primary|Fatigue|The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is −24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.|four cycles of chemotherapy|All participants that were randomized and began the protocol were included in analyses.||units on a scale||Standard Error|Mean
138928|NCT00478244|Primary|Number of Patients With Detectable Collagen Type VII|Number of patients with epidermolysis bullosa who had collagen type VII. Type VII collagen defects cause recessive dystrophic epidermolysis bullosa (RDEB), a blistering skin disorder often accompanied by epidermal cancers.|Day 100 Post Transplant|||participants|||Number
138929|NCT00478244|Secondary|Number of Patients With Neutrophil Engraftment|Number of patients with an absolute neutrophil count >5 x 10^8 cells/liter for 3 consecutive days.|Day 42 Post Transplant|||participants|||Number
138930|NCT00478244|Secondary|Number of Patients With Resistance to Blister Formation|Resistance to Blister Formation demonstrated by response to negative pressure.|Month 1 through Month 24 Inclusive|Added blister formation testing later in study; only 2 patients had pre-transplant test.||participants|||Number
138931|NCT00478244|Secondary|Number of Patients With Donor Derived Cells in Skin|Number of patients who had donor skin chimerism - donor cells in the patient's epidermis (a state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease).|Day 90 Post Transplant|||participants|||Number
138932|NCT00478244|Secondary|Overall Survival|Survival is defined as the number of patients that were alive post transplant.|1 year and 2 years Post Transplant|||participants|||Number
138933|NCT00478244|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD)|Number of patients with cGVHD; a severe long-term complication created by infusion of donor cells into a foreign host.|Day 365 Post Transplant|||participants|||Number
138934|NCT00478244|Secondary|Number of Patients With Acute Graft-Versus-Host Disease (GVHD)|Number of patients with GVHD. Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.|Day 100 Post Transplant|||participants|||Number
138935|NCT00478244|Secondary|Number of Patients With Platelet Engraftment|Number of patients with a platelet count >5 x 10^10 cells/liter for 3 consecutive measurements.|Day 180 Post Transplant|||participants|||Number
138936|NCT00478244|Secondary|Number of Patients With Transplant-Related Mortality|Number of patients who died due to complications of the transplant (includes all deaths without previous relapse or progression).|Day 180 Post Transplant|||participants|||Number
138937|NCT00478244|Secondary|Number of Patients With >70% Donor Chimerism|Number of patients with donor chimerism - percentage of donor cells in the patient via the peripheral blood or bone marrow.|Days 21, 100, 180, 365 and 730 Post Transplant|||participants|||Number
138938|NCT00478231|Other Pre-specified|Number of Participants With Genotype Resistance|Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI).|Baseline through Week 96|FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. Here, the 'N = 167' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.||Participants|||Number
138939|NCT00478231|Other Pre-specified|Time to Virologic Failure (VF)|Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification.|Baseline to Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation.||Days||95% Confidence Interval|Median
139048|NCT00477594|Other Pre-specified|Lipoprotein(a) Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
138940|NCT00478231|Other Pre-specified|Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Missing data was imputed using LOCF.||log 10 copies/ml||Standard Deviation|Mean
138941|NCT00478231|Secondary|Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status|Virus tropism was done by the Monogram Biosciences Trofile assay.|Time of virologic failure (VF) and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Participants|||Number
138942|NCT00478231|Secondary|Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percent CD8||Standard Deviation|Mean
138943|NCT00478231|Secondary|Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percent CD4||Standard Deviation|Mean
138944|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||cells/µL||Standard Deviation|Mean
138945|NCT00478231|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS population included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||cells per microliter (cells/µL)||Standard Deviation|Mean
138946|NCT00478231|Secondary|Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification|Below limit of quantification was defined as less than 400 copies/milliliter (mL)|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percentage of participants|||Number
138947|NCT00478231|Secondary|Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT|The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF.||Percentage of participants|||Number
138948|NCT00478231|Secondary|Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)||Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)|The full analysis set (FAS) included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Last Observation Carried Forward (LOCF) method was used.||Percentage of participants|||Number
138949|NCT00478231|Primary|Number of Participants With Laboratory Test Abnormalities|Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
138950|NCT00478231|Primary|Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections|Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
138951|NCT00478231|Primary|Number of Participants With Treatment Emergent Malignancies||Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
139046|NCT00477594|Other Pre-specified|Very-Low-Density Lipoprotein (VLDL) Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
138952|NCT00478231|Primary|Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities|Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or ET|The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.||Participants|||Number
138953|NCT00478231|Primary|Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant’s usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.|Baseline to 30 days post-week 96 or early termination (ET)|The safety analysis set composed of all participants who received at least one dose of study medication.||Participants|||Number
138954|NCT00478218|Secondary|Duration of Response (DOR)|Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Participants who achieved a partial response(PR) or better were evaluable for this analysis.||months||95% Confidence Interval|Median
138955|NCT00478218|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method. > Progression was defined as any one or more of the following: > An increase of 25% from lowest confirmed response in: >~Serum M-component (absolute increase >= 0.5g/dl) >~Urine M-component (absolute increase >= 200mg/24hour >~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl >~Bone marrow plasma cell percentage (absolute increase of >=10%)"|up to 5 years|||months||95% Confidence Interval|Median
138956|NCT00478218|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|||months||95% Confidence Interval|Median
138957|NCT00478218|Primary|Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment|"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Duration of Treatment (up to 5 years)|||participants|||Number
138958|NCT00478205|Primary|Overall Change From Baseline in Modified CIBIC+ to Week 24|The CIBIC+ is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).|Baseline and Week 24|ITT population, LOCF||Scores on a scale||Standard Deviation|Mean
138959|NCT00478205|Secondary|Change From Baseline to Week 24 in MMSE Total Score|The MMSE (Mini-Mental State Examination) is a 30-item test that evaluates 5 domains of cognitive function (orientation to time and place, immediate and delayed recall, attention, calculation, and language). The scores range from 0 (most impaired) to 30 (no impaiment).|Baseline and Week 24|ITT population, LOCF||Scores on a scale||Standard Deviation|Mean
138960|NCT00478205|Secondary|Change From Baseline to Week 24 in ADCS-ADL Total Score|The ADCS-ADL (Alzhemier's Disease Cooperative Study-Activities of Daily Living) is a 19-item assessment scale used to measure a patient's basic functional abilities, such as walking, grooming, and bathing.Scores range from 0 to 54, with a higher score indicating greater functional ability.|Baseline and Week 24|ITT population, LOCF||Scores on a scale||Standard Deviation|Mean
138961|NCT00478205|Primary|Change From Baseline to Week 24 in SIB Total Score|The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.|Baseline and Week 24|Intent-to-treat (ITT) population: All Randomized patients in Safety Population and Severe Impairment Battery (SIB) or Clinician Interview-Based Impression of Severity Plus Caregiver Input (CIBIS+) data available at Baseline and SIB or Clinician Interview-Based Impression of Change Plus caregiver Input (CIBIC+ ) data available post-Baseline; LOCF||Scores on a scale||Standard Error|Least Squares Mean
138962|NCT00478192|Secondary|Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment|"Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.~Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point – Baseline"|Baseline, Hour 24 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mL||Standard Deviation|Mean
139047|NCT00477594|Other Pre-specified|Percent Change From Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol|Very-Low-Density Lipoprotein (VLDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
138963|NCT00478192|Secondary|Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment|"Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.~Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point – Baseline"|Baseline, Hour 12, Hour 24,Hour 36 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mL||Standard Deviation|Mean
138964|NCT00478192|Secondary|Baseline –Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours|"Each individual subject's change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.~t=48 Hours"|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Hour * mEq/L||Standard Deviation|Mean
138965|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >6 mEq/L or two consecutive measurements >135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Patients|||Number
138966|NCT00478192|Secondary|Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours|Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Patients|||Number
138967|NCT00478192|Secondary|Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium|"Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~The endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported."|48 Hours|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.||Hours||Inter-Quartile Range|Median
138968|NCT00478192|Secondary|Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Actual Data for each time point - Baseline"|Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mEq/L||Standard Deviation|Mean
138969|NCT00478192|Primary|Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.|"Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.~Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.~Change is calculated as Hour 48 - Baseline."|Baseline and 48 hours|"Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles."||mEq/L||Standard Deviation|Mean
138970|NCT00478140|Secondary|Overall Survival|Length of time from date of starting treatment that participants are still alive|Up to 3.5 years||||||
138971|NCT00478140|Secondary|Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.|Up to 3 years||||||
138972|NCT00478140|Secondary|Disease Control Rate|Percentage of participants who have achieved complete response, partial response and stable disease|Up to 3.5 years||||||
138973|NCT00478140|Primary|Objective Response (Complete and Partial Response)|Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 63 days or until disease progression|Only those participants who had measurable disease present at baseline, received at least one cycle of therapy, and had disease re-evaluated considered evaluable for response; therefore one participant was inevaluable.||participants|||Number
139044|NCT00477594|Other Pre-specified|Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||ratio||Inter-Quartile Range|Median
138974|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment|"The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.~SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)"|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.||Participants|||Number
138975|NCT00477334|Secondary|The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment|The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.|Baseline, Day 2|304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.||Participants|||Number
138976|NCT00477334|Secondary|Time to Second Recurrence of Genital Herpes|Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.|6 months|Intent to Treat Population: participants who completed the first recurrence.||Days||Inter-Quartile Range|Median
138977|NCT00477334|Secondary|Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period|Number of participants with a second recurrence of genital herpes in the follow-up period.|6 months|Intent to Treat Population: participants who completed the first recurrence.||Participants|||Number
138978|NCT00477334|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.|72 hour after initiation of study medication up to 21 days|Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis.||Days||Inter-Quartile Range|Median
138979|NCT00477334|Secondary|Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions|Kaplan-Meier estimation.|21 days|ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non aborted lesion stages and without a final assessment on aborted lesion status were assumed as having non aborted lesions in this analysis.||Days||Inter-Quartile Range|Median
138980|NCT00477334|Secondary|Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period||21 days|Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences.||Percentage of Participants|||Number
138981|NCT00477334|Primary|Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).|21 days|Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period.||Days||Inter-Quartile Range|Median
138982|NCT00477295|Secondary|Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1|The European Quality of Life Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a preference based generic health related quality of life (HRQoL) instrument which classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels, they are (1) no problems, (2) some problems, (3) extreme problems. The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score.|Week 31 through Week 83|Intent-to-Treat Population. This was measured using Observed Case (OC). The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score (n=174,196).||Percentage of Participants|||Number
138983|NCT00477295|Secondary|Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1|The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
138984|NCT00477295|Secondary|Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1|"The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall~Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales:~10 (Best possible quality of life) - 0 (Worst possible quality of life);~Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
141864|NCT00454181|Secondary|Subject Questionnaire Regarding Global Oral Changes|"Number of subjects reporting change in global oral health from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to end of treatment|||participants|||Number
138985|NCT00477295|Secondary|Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1|"The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line.~Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria."|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
138986|NCT00477295|Secondary|Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1|The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems.|Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication. This was measured using Observed Case (OC).||Scores on a Scale||Standard Deviation|Mean
138987|NCT00477295|Secondary|Time to 12-months Seizure Freedom|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|ITT Population||Days||Standard Deviation|Mean
138988|NCT00477295|Secondary|Time to 6-months Seizure Freedom|A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 83|Intent-to-Treat (ITT) Population - randomized subjects who received at least one dose of study medication.||Days||Standard Deviation|Mean
138989|NCT00477295|Secondary|Analysis of Time to Drop Out Due to Lack of Efficacy|Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy.|Week 1 through Week 109|Per Protocol Population||Median Days||Standard Error|Median
138990|NCT00477295|Secondary|Analysis of Time to Drop Out Due to an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline.|Week 1 through Week 109|Per Protocol Population||Median Days||Standard Error|Median
138991|NCT00477295|Secondary|Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period|A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 5 through Week 109|Per Protocol Population. N=number of subjects with evaluable data.||Percentage of participants|||Number
138992|NCT00477295|Primary|Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase|A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.|Week 31 through Week 109|Per Protocol Population: All randomized subjects who received at least one dose of study medication and who had no major protocol violations.||Percentage of Participants|||Number
138993|NCT00477269|Secondary|Blood Gas Measurement - pH at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||pH scale||Standard Deviation|Mean
138994|NCT00477269|Secondary|Blood Gas Measurement - Venous Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||percentage of saturation||Standard Deviation|Mean
138995|NCT00477269|Secondary|Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||percentage of saturation||Standard Deviation|Mean
138996|NCT00477269|Secondary|Blood Gas Measurement - PvO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
138997|NCT00477269|Secondary|Blood Gas Measurement - PaCO2 at Baseline and Study Completion|The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
138999|NCT00477269|Secondary|Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta – Pright atrium)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||dyn*s/cm^5||Standard Deviation|Mean
139000|NCT00477269|Secondary|Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP – PCWP)/CO|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||dyn*s/cm^5||Standard Deviation|Mean
139001|NCT00477269|Secondary|Mean Cardiac Output (CO) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||L/min||Standard Deviation|Mean
139002|NCT00477269|Secondary|Mean Heart Rate (HR) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
139003|NCT00477269|Secondary|Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
139004|NCT00477269|Secondary|Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
139005|NCT00477269|Secondary|Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion|The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.|Baseline, and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
139006|NCT00477269|Secondary|Borg Score During the Six Minutes Walk Test at Different Time Periods|Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||score on a scale||Standard Deviation|Mean
139007|NCT00477269|Secondary|Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||beats per minute (bpm)||Standard Deviation|Mean
139008|NCT00477269|Secondary|Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
139009|NCT00477269|Secondary|Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||mmHg||Standard Deviation|Mean
139010|NCT00477269|Secondary|Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods|Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||Percentage of Oxygen Saturation||Standard Deviation|Mean
139011|NCT00477269|Secondary|Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity|PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||number of participants|||Number
139012|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||minutes||Standard Deviation|Mean
139013|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||number of stops||Standard Deviation|Mean
139014|NCT00477269|Primary|Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods|The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)|The intention to treat population (ITT) will include all patients who received at least one dose of study medication.||meters||Standard Deviation|Mean
139015|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|72 months|No formal statistical analysis was performed in the extension phase of this study so no analysis data sets were defined. All summaries are based on all patients enrolled.||participants|||Number
139016|NCT00477269|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core|In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.|6 months|Safety Population all participants enrolled was included in this population||participants|||Number
139017|NCT00477230|Primary|Freedom for Symptomatic Episode of Atrial Fibrillation at One Year||One Year|Early study termination before one year.||participants|||Number
139018|NCT00478036|Primary|Interocular Pressure|IOP, measured by Goldmann applanation tonometry|8 weeks|Reported for subjects for whom all IOP values were available for all of the visits.||mmHg||Standard Deviation|Mean
139045|NCT00477594|Other Pre-specified|Percent Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol||Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139019|NCT00478023|Secondary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity|"Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline value to 48 hours after first study drug intake.|Intention to treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.||units on scale||Standard Deviation|Mean
139020|NCT00478023|Primary|Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.|"Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0)."|Baseline to 24 hours after first intake of study drug|Intention to Treat (ITT) and Last Observation Carried Forward (LOCF), i.e. all randomized subjects who received any amount of Investigational Medicinal Product (IMP = study drug) and had a non missing baseline pain assessment.||units on scale||Standard Deviation|Mean
139021|NCT00477971|Post-Hoc|3-Year Progression Free Survival|"Percentage of patients who were progression free at 3 years. The 3-year progression free rate was estimated using the Kaplan Meier method.~Progression is assessed when one of the following occur:~reappearance of monoclonal protein by immunofixation,~Increase in serum monoclonal paraprotein to >25% above the lowest response level,~Increase in urine M-protein to > 25% above the lowest remission value for 24-hour excretion."|3 years|||percentage of participants||95% Confidence Interval|Number
139022|NCT00477971|Secondary|Organ Response to Treatment|"Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid.~Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of >= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by >= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either >= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to < 50% of previous movements/day, or decrease in fecal fat excretion by 50%."|10 years|||percentage of participants||95% Confidence Interval|Number
139023|NCT00477971|Secondary|3 Year Overall Survival|Percentage of patients who were alive at 3 years. The 3-year survival rate was estimated using the Kaplan Meier method.|3 years|||percentage of participants||95% Confidence Interval|Number
139024|NCT00477971|Primary|Hematologic Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment. A hematologic response consisted of a Complete response, Very Good Partial Response or Partial Response.~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response (VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response (PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|10 years|||percentage of participants||95% Confidence Interval|Number
139025|NCT00477750|Secondary|Patients With Grade 3 or Higher Adverse Events|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.|Every cycle during treatment||||||
139026|NCT00477750|Secondary|Duration of Response (DOR)|Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation.|from first response to progression or death (up to 3 years)||||||
139027|NCT00477750|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up.|registration to death (up to 3 years)||||||
139028|NCT00477750|Secondary|Time to Progression (TTP)|TTP was defined as the time from registration to disease progression. Patients who died were considered to have disease progression at time of death unless documented evidence clearly indicates no progression has occurred|registration to progressive disease (up to 3 years)||||||
139029|NCT00477750|Primary|Patients With Overall Confirmed Response|"Response that was confirmed on 2 consecutive evaluations. >~Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow >~Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours >~Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells"|Every cycle during treatment|||participants|||Number
139030|NCT00477685|Primary|Preoperative and Postoperative Intraocular Pressure|The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.|baseline and 90 days|||mm Hg||Standard Deviation|Mean
139031|NCT00477685|Secondary|Number of Participants With Any Complications or Adverse Events.|Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.|180 day|||participants|||Number
139049|NCT00477594|Other Pre-specified|Percent Change From Baseline in Lipoprotein(a)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139032|NCT00477672|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Per Protocol population, which includes subjects in the ITT analysis set, who were free of important protocol deviations, as defined before database lock and unblinding. Subjects were analyzed according to the treatment actually received."||Score on UPDRS-II+III||95% Confidence Interval|Least Squares Mean
139033|NCT00477672|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method."|Each study visit (i.e. Days 1, 8, 15, 29 and 42)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug, and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment."||Score on the SAPS H+D scale||95% Confidence Interval|Least Squares Mean
139034|NCT00477633|Secondary|Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population|"Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain mean median duration of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated."|12 cycles (28 days each), approximately 336 days|MITT Population||Days||Standard Deviation|Mean
139035|NCT00477633|Secondary|Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population||12 cycles (28 days each), approximately 336 days|MITT Population||Days||Standard Deviation|Mean
139036|NCT00477633|Primary|Pearl Index, 18-35 Years, MITT Population|Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment|13 cycles (28 days each), approximately 364 days|MITT Population, Subjects Aged 18-35 years||Pearl Index||95% Confidence Interval|Number
139037|NCT00477607|Secondary|Total Amount of Prescribed Cisplatin Dose Administered|Maximum cumulative dose of cisplatin (mg/m^2) administered during the course of chemotherapy.|cisplatin treatment period between 10 weeks and up to 16 weeks.|Subjects from the original 39 recruited who had sufficient chemotherapy data recorded to measure cumulative dose.||mg/m^2||Standard Deviation|Mean
139038|NCT00477607|Secondary|Malondialdehyde (MDA) Levels|Computed maximum increase relative to baseline for each subject = (max MDA during treatment) - baseline MDA level.|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Non-missing MDA measurements from 23 subjects in primary outcome analysis||uM=micro-moles/liter||Standard Deviation|Mean
139039|NCT00477607|Primary|Ototoxicity Measurement|"Any American Speech and Hearing Association (ASHA)-significant hearing loss in the Sensitive Region for Ototoxicity frequencies between baseline measurement and any follow-up measurement.~ASHA criteria are defined as~20 decibel (dB) increase at any test frequency,~10 dB increase at any two consecutive test frequencies, or loss of response where there was previously a response at any three test frequencies."|Baseline measurement occurred prior to first cisplatin treatment session. Follow-up measurements occurred up to 3 months after last cisplatin treatment.|Intent-to-treat (ITT)||participants|||Number
139040|NCT00477594|Other Pre-specified|High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
139041|NCT00477594|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol|High-Density Lipoprotein (HDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139042|NCT00477594|Other Pre-specified|Apolipoprotein A1 Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
139043|NCT00477594|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139114|NCT00476827|Secondary|To Assess the Quality of Life During Treatment With This Therapeutic Approach|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks||||||
139050|NCT00477594|Other Pre-specified|Triglycerides Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
139051|NCT00477594|Other Pre-specified|Percent Change From Baseline in Triglycerides|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139052|NCT00477594|Secondary|Percent Change From Baseline in Respiratory Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set||percentage of baseline||Standard Deviation|Mean
139053|NCT00477594|Secondary|Percent Change From Baseline in Pulse Rate||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set||percentage of baseline||Standard Deviation|Mean
139054|NCT00477594|Secondary|Percent Change From Baseline in Blood Pressure||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set||percentage of baseline||Standard Deviation|Mean
139055|NCT00477594|Secondary|Percent Change From Baseline in Hematology Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment|Safety set||percentage of baseline||Standard Deviation|Mean
139056|NCT00477594|Secondary|Percent Change From Baseline in Clinical Chemistry Parameters||Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.|Safety set.||percentage of baseline||Standard Deviation|Mean
139057|NCT00477594|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs were considered as related if assessed by the Investigator as possibly, probably or definitely related to study drug. The severity of each event was assessed using the following categories: Mild (symptom(s) barely noticeable to the patient or do not make the patient uncomfortable); Moderate (symptom(s) of a sufficient severity to make the patient uncomfortable, performance of daily activities is influenced) or Severe (symptom(s) of a sufficient severity to cause the patient severe discomfort, may cause cessation of treatment with the study drug). Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|2 years|Safety set||participants|||Number
139058|NCT00477594|Secondary|Non-High-Density Lipoprotein Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
139059|NCT00477594|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139060|NCT00477594|Secondary|Total Cholesterol Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
139061|NCT00477594|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139062|NCT00477594|Secondary|Apolipoprotein B Over Time|For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
139063|NCT00477594|Secondary|Percent Change From Baseline in Apolipoprotein B|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139064|NCT00477594|Primary|Low-density Lipoprotein Cholesterol (LDL-C) Over Time|Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104.|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||mg/dL||Inter-Quartile Range|Median
139065|NCT00477594|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.|Baseline and Weeks 52 and 104|"The Safety Set included all enrolled patients who received at least 1 injection of study drug. N indicates the number of participants with available data at the specified time point."||percentage of baseline||Inter-Quartile Range|Median
139066|NCT00477490|Secondary|Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Week 5 up to Day 169|Part II Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part II.||participants|||Number
139067|NCT00477490|Secondary|Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I|A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.|Day 1 up to Week 4 (end of Part I)|Part I Safety Population includes study participants who received study intervention and had at least one safety assessment during study Part I.||participants|||Number
139068|NCT00477490|Secondary|Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4|The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
139069|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4|The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
139070|NCT00477490|Secondary|Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4|The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
139071|NCT00477490|Secondary|Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4|The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat population of participants who completed the questionnaire at both baseline and end of Part 1.||units on a scale||Standard Deviation|Mean
139072|NCT00477490|Secondary|Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4|Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|ITT population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants with both baseline and Week 4/Day 28/End of Part I data are included.||minutes||Standard Deviation|Mean
139073|NCT00477490|Secondary|Part I: Change From Baseline in Total Reported Sleep Time at Week 4|Total sleep time was recorded by participants in study diaries.|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized subjects who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids) during Part I were included in the ITT analysis dataset. Participants analyzed had baseline and Week 4/Day 28/End of Part 1 measurements.||minutes||Standard Deviation|Mean
139074|NCT00477490|Secondary|Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations. Participants had data representing the visit.||percentage of participants|||Number
139075|NCT00477490|Secondary|Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169|Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.|- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169|Observed Cases (OC) Analysis Set which consisted of participants who had information on mean number of nocturnal voids for both the screening visit and the final visit in Part I (Day 28) and did not have any major protocol deviations.||nocturnal voids||Standard Deviation|Mean
139076|NCT00477490|Primary|Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4|"Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.~This was the second co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset||percentage of participants|||Number
139077|NCT00477490|Primary|Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4|"The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.~This was the first co-primary outcome."|- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)|Intent to treat (ITT) population --All randomized participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., nocturnal voids) during Part I were included in the ITT analysis dataset||nocturnal voids||Standard Deviation|Mean
139078|NCT00477464|Secondary|Trough Concentration of Capecitabine, 5-FU, and FBAL|PK samples were collected at pre-dose on Day 14 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|ITT Population. Evaluable samples were not taken from some participants.||ng/ml||Standard Deviation|Mean
139079|NCT00477464|Secondary|Trough Concentration of Lapatinib|PK samples were collected at pre-dose on Day 14 and Day 21 (minus 2 days). Trough concentration is defined as the minimum serum concentration at steady state after a repeated dose of lapatinib.|Week 2|ITT Population. Evaluable samples were not taken from some participants.||ng/ml||Standard Deviation|Mean
139080|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12) of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 12 hours after dosing (AUC 0-12). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
139081|NCT00477464|Secondary|AUC0-tau of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
139082|NCT00477464|Secondary|t1/2 of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
139083|NCT00477464|Secondary|Tmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of dosing. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
139115|NCT00476827|Primary|Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer|Due to slow accrual study was prematurely closed and endpoint not analysed|trial closure|Due to slow accrual study was prematurely closed and endpoint not analysed|||||
139084|NCT00477464|Secondary|Cmax of Capecitabine, 5'-Fluorouracil (5-FU), and Alpha-fluoro-beta-alanine (FBAL)|PK samples were collected at pre-dose, and at 0.5 (plus or minus 5 minutes), 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, and 10 hr (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of drug. 5-FU and FBAL were evaluated because of the following reasons: (1) capecitabine is an orally administered fluoropyrimidine carbamate selectively activated to fluorouracil (5-FU) in tumors; (2) FBAL is an inactive major metabolite of capecitabine, and metabolites of capecitabine are excreted mainly in urine.|Week 2|PK Population. One participant was excluded due to dose reduction.||ng/ml||95% Confidence Interval|Geometric Mean
139085|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours AUC0-24 of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to 24 hour after dosing (AUC 0-24). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
139086|NCT00477464|Secondary|Area Under the Plasma Concentration-time Curve Within the Dosing Interval AUC0-tau of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. AUC is defined as the area under the concentration-time curve from 0 to last quantifiable concentration (AUC 0-tau). AUC is a measure of exposure.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr*ng/ml||95% Confidence Interval|Geometric Mean
139087|NCT00477464|Secondary|Terminal Elimination Half-life (t1/2) of Lapatinib|Terminal elimination half-life is defined as the duration until observation of half of the maximum concentration. PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
139088|NCT00477464|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lapatinib|PK samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hr (plus or minus 30 minutes) after dosing. Tmax is defined as the time to peak concentration from initiation of lapatinib dosing.|Week 2|PK Population. One participant was excluded due to dose reduction.||hr||95% Confidence Interval|Geometric Mean
139089|NCT00477464|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib|Pharmacokinetic (PK) samples were collected at pre-dose, and at 1, 2, 3, 4 (plus or minus 15 minutes), 6, 8, 10, 12, and 24 hours (hr) (plus or minus 30 minutes) after dosing. Cmax is defined as the maximum concentration of lapatinib.|Week 2|PK Population: consisted of the first six participants who were enrolled into the study and evaluable for the PK parameters of the investigational products. One participant was excluded due to dose reduction.||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
139090|NCT00477464|Secondary|Duration of Response (Independent Reviewer-assessed)|For the subset of participants who showed a complete or partial response, duration of response is defined as the time from the first documented evidence of partial or complete tumor response until the first documented sign of disease progression or death due to breast cancer, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response||weeks||95% Confidence Interval|Median
139091|NCT00477464|Secondary|Time to Response (Independent Reviewer-assessed)|Time to response is defined as the time from the start of treatment until the first documented evidence of complete response or partial response.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|Participants in the ITT Population achieving a partial or complete response||weeks||95% Confidence Interval|Median
139092|NCT00477464|Secondary|Overall Survival (Independent Reviewer-assessed)|Overall survival is defined as the time from the start of treatment until death regardless of cause. For participants who did not die, time to death was censored at the time of last confirmation of survival.|Baseline and then followed every 4 weeks until death (up to Week 157.9) while on treatment. After treatment termination, followed every 12 weeks until death (up to Week 157.9)|ITT Population||weeks||95% Confidence Interval|Median
139093|NCT00477464|Secondary|Objective Response (Independent Reviewer-assessed)|Objective response is defined as the percentage of participants achieving a best overall response classified as a complete or partial (confirmed) tumor response. Complete response is defined as the disappearance of all target or non-target lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Baseline every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population||percentage of participants|||Number
139094|NCT00477464|Secondary|6-Month Progression-free Survival (Independent Reviewer-assessed)|6-Month progression-free survival is defined as the percentage of participants surviving without progressive disease at 6 months (24 weeks) after the start of treatment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Baseline and then every 6 weeks until Month 6 (Week 24)|ITT Population||percentage of participants|||Number
139095|NCT00477464|Secondary|Progression-free Survival (PFS) (Independent Reviewer-assessed)|PFS is defined as the interval between the start of treatment and the earliest date of disease progression or death of any cause, if sooner.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death (up to Week 119)|ITT Population||weeks||95% Confidence Interval|Median
139096|NCT00477464|Secondary|Time to Progression (Independent Reviewer-assessed)|Time to progression is defined as the interval between the start of treatment and the earliest date of disease progression or death due to breast cancer, if sooner. Time to progression was calculated by using the Kaplan Meier estimate.|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression or death due to breast cancer (up to Week 119)|ITT Population||weeks||95% Confidence Interval|Median
139116|NCT00476827|Secondary|Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival.|Due to slow accrual study was prematurely closed and endpoint not analysed|8 to 9 weeks|Due to slow accrual study was prematurely closed and endpoint not analysed|||||
139117|NCT00476827|Primary|Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria.|Primary endpoint has not been analysed secondary to slow and low accrual numbers.|May 2009|Endpoint has not been analysed secondary to slow and low accrual numbers.|||||
139097|NCT00477464|Primary|Clinical Benefit Response (Independent Reviewer-assessed)|"CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A “complete response” is defined as the disappearance of all target or non-target lesions, “partial response” and disease progression as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and “stable disease” as neither “partial response” nor “disease progression.”"|Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)|Intent-to-treat (ITT) Population: participants who had received at least one dose of study medication.||percentage of participants|||Number
139098|NCT00477386|Secondary|Phase II: Progression Free Survival|Progression free survival times will be estimated using the Kaplan-Meier method. If a patient progresses or dies, the time till that event will be used. If a patient does not progress or die on the study, the patient will be censored at the last available visit. Confidence intervals on the median will be constructed.|Baseline until disease progression or last visit|All Patients in Phase II of the study||Months||95% Confidence Interval|Median
139099|NCT00477386|Secondary|Phase II: Percent of Patients With Objective Response, CA125 Response or Stable Disease > 3 Months|The percent of patients having an objective response (Complete Response or Partial Response) or CA125 response (Complete Response or Partial Response) or stable disease > 3 months will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study||percent of patients||95% Confidence Interval|Number
139100|NCT00477386|Primary|Phase II: Percent of Patients With Objective Response|The percent of patients having an objective response (Complete Response or Partial Response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.|screening until end of study (approx 12-18 months)|All Patients in Phase II of the study||percent of participants||95% Confidence Interval|Number
139101|NCT00477386|Primary|Phase I: Maximum Tolerated Dose (MTD) for Use in Phase II|The definition of MTD will follow the standard definition of the phase I 3+3 trial concept. Dose Limiting Toxicities (DLTs) will be scored in the first cycle. Patients will be monitored for 28 days (a cycle) to determine whether a DLT is experienced for the specific dose level.|28 days|All patients assigned to Phase I of the study||mg/m2 IV QD x 5 days|||Number
139102|NCT00477204|Secondary|No Secondary Outcomes|No secondary outcomes were measured as recruitment was insufficient and study was stopped after only 9 subjects completed trial.|6 months||||||
139103|NCT00477204|Primary|Change in LDL-c From Baseline to 6 Months in Subjects With Type 1 Diabetes Taking Vytorin or Zocor.|Change in LDL-c between Zocor and Vytorin treatment in subjects with Type 1 Diabetes measured at baseline to the 6-month study visit.|Baseline to 6 months|Recruitment for this study failed to meet target. Due to the small sample size the analyses of these data were primarily descriptive.||mg/dl||Standard Deviation|Mean
139104|NCT00477191|Secondary|Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.|Analyzing the safety and tolerability of Etanercept which is being measured through the number of adverse events related to Entanercept over a 6-month period.|6 months|||number of events|||Number
139105|NCT00477191|Secondary|Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months|Reactive hyperemia index (RHI) is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post –to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction. The possible range of scores is 1 to 3 and a lower score has a worse outcome.|6 months|||units on a scale||Standard Deviation|Mean
139106|NCT00477191|Secondary|Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.|6 months|||mg/dl||Standard Deviation|Mean
139107|NCT00477191|Primary|Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome|Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome|6 months|||ng/mL||Standard Deviation|Mean
139108|NCT00477152|Secondary|Post-treatment Gorelick Dehydration Score|Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.|At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)||No. moderate/severe symptoms (max = 10)||Standard Deviation|Mean
139109|NCT00477152|Secondary|Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter||At end of placement of SC catheter|ITT (all treated patients)||participants|||Number
139110|NCT00477152|Primary|Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)||participants|||Number
139111|NCT00477152|Primary|HYLENEX-facilitated Subcutaneous (SC) Rehydration Success|Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home|At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)|ITT (all treated patients)||participants|||Number
139112|NCT00476957|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions|Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions|3 years|||participants|||Number
139113|NCT00476957|Primary|To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation|Definite or probable stent thrombosis rate.|3 years|||participants|||Number
139124|NCT00476476|Primary|Response Rate|Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).|Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).|The analysis dataset is comprised of response evaluable patients.||proportion of participants||90% Confidence Interval|Number
139125|NCT00476242|Secondary|Opiate Craving Based on Heroin Craving Scale||measured daily for 12 weeks of study or length of participation||||||
139126|NCT00476242|Primary|Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).||Week 12|||participants|||Number
139127|NCT00476242|Primary|Opiate Use Measured by Urine Toxicology Results|Opiate use was qualified by the number of opiate positive urine results.|3x/week during 12 weeks of the trial or study participation|||Percent of total urine samples||Inter-Quartile Range|Median
139128|NCT00476229|Primary|Composite Success Rate|Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Baseline to Day 100, assessment at Day 100|Analysis was per protocol. One participant was inevaluable.||Percentage of participants|||Number
139129|NCT00476151|Primary|Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.|diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.|baseline and 4 weeks treatment|ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation||units on a scale||95% Confidence Interval|Least Squares Mean
139130|NCT00476086|Secondary|Radiation Therapy Completion Rate|Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease|Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.|The analysis dataset is comprised of all participants who started chemotherapy.||percentage of participants||90% Confidence Interval|Number
139131|NCT00476086|Primary|Chemotherapy Completion Rate|Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.|3 cycles of chemotherapy which approximates 3 months given the 28-day cycle|The analysis dataset is comprised of all participants who started chemotherapy.||percentage of participants||90% Confidence Interval|Number
139132|NCT00476021|Secondary|Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion||6 months|||participants|||Number
139133|NCT00476021|Secondary|Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates||6 months|||participants|||Number
139134|NCT00476021|Secondary|Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography||6 months|The population only includes women who received IUDs at the specified timepoint. Only 50/51 women in the postplacental group had a successful IUD insertion postplacentally. Only 46 of 51 women in the delayed group returned for a delayed IUD insertion.||participants|||Number
139135|NCT00476021|Secondary|Follow-up Rates for Delayed Insertion of LNG-IUD||6 months|||participants|||Number
139136|NCT00476021|Secondary|Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement||6 months|||participants|||Number
139137|NCT00476021|Primary|IUD Usage Rate at 6 Months|Usage rate of the LNG-IUD at 6 months after delivery|6 months after delivery|IUD use at 6 months, lost to follow-up counted as failures||participants|||Number
139138|NCT00476008|Secondary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
139139|NCT00476008|Secondary|Cognitive Dementia Rating Scale|This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
139140|NCT00476008|Secondary|Motor Free Visual Perception Test - Visual Closure Subtest|This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment.|baseline and 12 months|||number incorrect||Standard Deviation|Mean
139141|NCT00476008|Secondary|Useful Field of View|The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
139142|NCT00476008|Secondary|Mini Mental Status Exam|Scores range from 0-30 with lower scores indicating decreased functioning.|baseline and 12 months|||units on a scale||Standard Deviation|Mean
140393|NCT00466167|Secondary|Response in Patient Global Impression (PGI-I)|PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Participants|||Number
139145|NCT00476008|Secondary|Rey Complex Figure Test|This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment|baseline and 12 months|||units on a scale||Standard Deviation|Mean
139146|NCT00476008|Secondary|Fuld Object Memory Evaluation|"Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity.~Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment."|baseline and 12 months|||units on a scale||Standard Deviation|Mean
139147|NCT00476008|Primary|The Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able to Pass the DriveABLE On-Road Test at Month 12 (Endpoint).|The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles.|Baseline and 12 months|One subject in the placebo group could not complete the driving test at 12 months due to his vision being below the legal limit to drive.||participants|||Number
139148|NCT00475904|Primary|Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin|Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline to 28 Days|Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique||units on a scale||95% Confidence Interval|Least Squares Mean
139149|NCT00475904|Primary|Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.|Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.|baseline and 28 days|This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.||units on a scale||95% Confidence Interval|Mean
139150|NCT00475878|Secondary|Depressive Symptoms|Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.|3 months|participants who were fully eligible for the study, completed the enrollment process and began study medication were included in an intent to treat analysis||units on a scale||Standard Error|Mean
139151|NCT00475878|Primary|Percentage of Participants Who Dropped Out of Buprenorphine Treatment|Drop-out is defined as 7 or more days of missed Buprenorphine doses|3 months|Participants who were fully eligible for the study, completed the enrollment process and began study medication were used in an intent to treat analysis.||percentage of participants|||Number
139152|NCT00475865|Secondary|Pharmacokinetic [PK]: Teriflunomide Plasma Concentration|Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.|24 weeks|All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.||micrograms/mililiter (μg/mL)||Standard Deviation|Mean
139153|NCT00475865|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group and region of enrollment as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||relapses per year||95% Confidence Interval|Number
139154|NCT00475865|Secondary|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters per scan|||Number
139155|NCT00475865|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)."|24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||lesions per scan||95% Confidence Interval|Number
139180|NCT00475735|Secondary|>/=1-point Improvement in the CGI-S Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment||||||
139156|NCT00475865|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors)."|baseline (before randomization) and 24 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||mililiters (mL)||Standard Error|Least Squares Mean
139157|NCT00475865|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
139158|NCT00475865|Primary|Overview of AE With Potential Risk of Occurrence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly hair loss and hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
139159|NCT00475865|Primary|Overview of Adverse Events (AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.||participants|||Number
139160|NCT00475852|Other Pre-specified|Number of Patients With Renal Impairment|Renal impairment was defined as a greater than 25% decrease from baseline in the Modification of Diet in Renal Disease calculated glomerular filtration rate.|Study drug initiation to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
139161|NCT00475852|Other Pre-specified|Cardiovascular Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee (CEC) and the cardiovascular deaths were classified by the CEC based on the primary causes.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
139162|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 180|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 180|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
139163|NCT00475852|Other Pre-specified|All-Cause Mortality Through Day 30|All deaths were adjudicated by an independent Clinical Events Committee.|Randomization to Day 30|The safety population consisted of all randomized patients who received any amount of study medication. For all safety analyses, patients were analyzed according to the treatment actually received. 66 and 68 patients in the nesiritide and placebo groups, respectively, were not included in the safety population.||Participants|||Number
139164|NCT00475852|Secondary|Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 162 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
139165|NCT00475852|Secondary|Number of Days Alive and Outside the Hospital||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 182 and 188 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Days||Standard Deviation|Mean
139166|NCT00475852|Secondary|Composite of Persistent or Worsening Heart Failure and All-Cause Mortality|Clinical manifestations of worsening or persistent decompensated heart failure were defined by at least one of the following: new, persistent or worsening: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiologic evidence of worsening heart failure. And was also defined by a new therapy specifically for the treatment of worsening or persistent decompensated heart failure.|Randomization to hospital discharge (up to Day 30)|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 105 and 115 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
139206|NCT00475501|Secondary|Dietary Protein Intake|"Dietary protein intake will be assessed using a 3-day food log and subjects will be counseled to increase protein intake if needed using the guide Healthy Ways to Eat More Protein."|baseline, 3 months, 6 months, 9 months, 12 months|||gm/body weight (kg)||Standard Error|Mean
139167|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 200 and 194 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
139168|NCT00475852|Secondary|Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug|Overall well-being was measured by patient self-assessed Likert scale at 6 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 158 and 147 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
139169|NCT00475852|Primary|Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 24 hours after study drug initiation. The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|24 hours after study drug initiation|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 193 and 179 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
139170|NCT00475852|Primary|Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug|Dyspnea symptoms were measured by patient self-assessed Likert scale at 6 hours after study drug initiation.The Likert scale is a 7-point ordinal categorical scale (the 7 categories are markedly better, moderately better, minimally better, unchanged, minimally worse, moderately worse, and markedly worse.)|6 hours after initiation of study drug|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 148 and 133 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
139171|NCT00475852|Primary|Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality||Randomization to Day 30|The modified intent-to-treat (MITT) population consisted of all randomized patients who received any amount of study medication and was the primary analysis population for all efficacy endpoints. 141 and 164 patients in the nesiritide and placebo groups, respectively, were not MITT population eligible or didn't have outcome measure of interest.||Participants|||Number
139172|NCT00475787|Secondary|Medical Outcome Study Short Form Physical Functioning Subscale|For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12.|baseline and 5 weeks|||percentage of change||95% Confidence Interval|Mean
139173|NCT00475787|Secondary|Performance of the Timed up and go Test|The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair.|baseline and 5 weeks|||percentage of change||95% Confidence Interval|Mean
139174|NCT00475787|Secondary|Oswestry Disability Index (ODI)|Validated measure of disability associated with lower back pain.|baseline and 5 weeks|||percentage of change||95% Confidence Interval|Mean
139175|NCT00475787|Secondary|Medical Outcome Study Short Form 36(SF-36) Bodily Pain|For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12.|baseline and 5 Weeks|||percentage of change||95% Confidence Interval|Mean
139176|NCT00475787|Primary|Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)|"100 mm line with 0 being no pain and 100 mm being the worst pain I can imagine."|Baseline, 5 weeks|||percentage of change from baseline to 5||95% Confidence Interval|Mean
139177|NCT00475735|Secondary|Mean Change From Baseline in the Clinical Global Impressions-severity of Illness Scale(CGI-S) Score|"The Clinical Global Impression - Severity of Illness Scale (CGI-S) is administered by a trained investigator who rates the severity of a patient's illness at the time of assessment, relative to the investigator's past experience with patients who have an ADHD diagnosis. The scores range from 1 to 7. Higher numbers correspond to more severe illness.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment||||||
139178|NCT00475735|Secondary|Mean Change From Baseline in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O:SV) Total ADHD Symptom Score.|"Conners' Adult ADHD Rating Scale – Observer Screening version (CAARS-O: SV) evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. It is a 30-item scale administered by a trained investigator or rater with cue questions. Each item is scored from 0 to 3 with higher scores corresponding to worse symptoms. The total score can range from 0 to 90.~Data not reported due to failure of primary hypothesis and program termination."|4 weeks of treatment||||||
139179|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Hyperactive/Impulsive Subscale Score|"The Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) hyperactive/impulsive subscale score consists of 9 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.~Data not reported due to failure of primary hypothesis and program termination"|4 weeks of treatment||||||
139207|NCT00475501|Secondary|Hematocrit|Hematocrit was assessed as a part of routine blood analysis at the indicated time points.|baseline, 3 months, 6 months, 9 months, 12 months|||% volume||Standard Error|Mean
139181|NCT00475735|Secondary|>/= 30% AISRS Total Score Responder Rate After 4 Weeks of Treatment;|"The AISRS total score consists of 18 items from the original ADHD-RS which were derived based on DSM-IV criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.~Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment||||||
139182|NCT00475735|Other Pre-specified|Baseline AISRS|"Baseline values for all treatment groups are equal because~the constrained longitudinal data analysis (cLDA) model was used~(Liang and Zeger, 2000, Sankhyā: The Indian Journal of Statistics, Series B 62, 134–148)."|Baseline|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.||score on scale||Standard Error|Least Squares Mean
139183|NCT00475735|Secondary|Mean Change From Baseline in the AISRS Inattentive Subscale Score After 4 Weeks of Treatment|"The AISRS inattentive subscale score consists of 9 items from the original ADHD-RS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.~Data not reported due to failure of primary hypothesis and program termination."|after 4 weeks of treatment||||||
139184|NCT00475735|Primary|Mean Change From Baseline in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (AISRS) Total Score After 4 Weeks of Treatment|The AISRS total score consists of 18 items from the original Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) which were derived based on Diagnostic and Statistical Manual-4 (DSM-IV) criteria for ADHD. The ADHD-RS include 9 items that address symptoms of inattention and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.|after 4 weeks of treatment|Full Analysis Set (FAS): The FAS included all randomized patients who received at least one dose of study medication. Patients with at least one assessment (baseline or post-randomization) were included in the FAS. Missing data were handled using the data as observed (DAO) approach.||score on scale||95% Confidence Interval|Least Squares Mean
139185|NCT00475722|Primary|Adherence to Dietary Goals|Percentage of participants who met 70% of diet goals as outlined in the exchange list|6 months|||percentage of participants meeting goals|||Number
139186|NCT00475709|Primary|Characterize the Hemodynamic Performance of the Valve.|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.~Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.~Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.||mm Hg||Standard Deviation|Mean
139187|NCT00475709|Primary|Characterize Patient NYHA Functional Classification Status.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|1 year|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.||percentage of participants|||Number
139188|NCT00475709|Primary|Late Adverse Event Rates|"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.~Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]"|Events occurring greater than or equal to 31 days post-implant.|Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.||percentage of events/late patient years|||Number
139189|NCT00475670|Secondary|Overall Survival|The time, in months, from BL to death due to any cause.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
139190|NCT00475670|Secondary|Overall Survival - Percentage of Participants Who Died|OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.|BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
139191|NCT00475670|Secondary|Percentage of Participants With Clinical Benefit According to RECIST Guidelines|Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants||95% Confidence Interval|Number
139192|NCT00475670|Secondary|Time to Treatment Failure|The time, in months, from BL to treatment failure.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
139193|NCT00475670|Secondary|Percentage of Participants With Treatment Failure|Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
139194|NCT00475670|Secondary|Progression-Free Survival|The time, in months, from BL to PFS event.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
139195|NCT00475670|Secondary|Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease|PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
139196|NCT00475670|Secondary|Duration of Response|The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||months||95% Confidence Interval|Median
139197|NCT00475670|Secondary|Duration of Response - Percentage of Participants With Progressive Disease or Death|Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.|BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS. Duration of response was assessed in participants with a best overall response of CR or PR. Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants|||Number
139198|NCT00475670|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines|CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.|Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited|FAS; Cohort A (trastuzumab monotherapy) was closed prematurely due to enrollment difficulties. Therefore, Cohort A included only 3 participants and none of the data from these 3 participants were analyzed for any of the specified endpoints.||percentage of participants||95% Confidence Interval|Number
139199|NCT00475657|Secondary|Stable Disease Rate|Trial terminated - results not analyzed|baseline to measured progressive disease|||participants|||Number
139200|NCT00475657|Secondary|Duration of Response|Trial terminated - results not analyzed|time of response to progressive disease|||months||Standard Deviation|Mean
139201|NCT00475657|Secondary|Progression Free Survival|Trial terminated - results not analyzed|baseline to measured progressive disease|||participants|||Number
139202|NCT00475657|Secondary|Overall Survival|Trial terminated - results not analyzed|baseline to date of death from any cause|||participants|||Number
139203|NCT00475657|Primary|Overall Response Rate|Trial terminated - results not analyzed|baseline to measured progressive disease|||participants|||Number
139204|NCT00475501|Secondary|Life Satisfaction|Life Satisfaction: is a written test of psychological well-being that will be performed at baseline, after 3, 6, 9 and 12 months of treatment. This is a 20-point scale, with a possible range of scores from 0 to 20. A higher score represents greater life satisfaction.|baseline, 3 months, 6 months, 9 months, 12 months|||points||Standard Error|Mean
139205|NCT00475501|Secondary|Transrectal Ultrasound Sizing of Prostate|Transrectal ultrasound sizing of prostate will be performed using the B&K Diagnostic System 3535, with 7 mega hertz transrectal probe at baseline and after 6 and 12 months of treatment.|baseline, 6 month, 12 months|||cc||Standard Error|Mean
139208|NCT00475501|Secondary|Benton Judgment of Line Orientation Test|"Benton Judgment of Line Orientation Test is a standardized test with 30 items that is specific for visual spatial cognition. Tests will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0, indicating low visual spatial cognition. The maximum score is 30, indicating high visual spatial cognition"|baseline, 3 months, 6 months, 9 months, 12 months|||units on a scale||Standard Error|Mean
139209|NCT00475501|Secondary|Trail-Making Test, Part A|Trail-Making Test, Part A: is a standardized test of cognitive function which specifically assesses working memory, visual processing, visual spatial skills, selective and divided attention, and psychomotor coordination. the test is scored as seconds required to successful completion of the task with a lower score representing better performance. The mean score on test is 30.75 second with a standard deviation of 16.27.|baseline, 3 months, 6 months, 9 months, 12 months|||sec||Standard Error|Mean
139210|NCT00475501|Secondary|30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test|"Rey Osterrieth Complex Figure (ROCF) test is a widely used standardized neuropsychological test for assessing visuospatial constructional functions, visuographic memory, and some aspects of planning.~The drawing is scored by a blinded neuropsychologist on a scale of 0 to 30 with 30 representing a perfect drawing."|baseline, 3 months, 6 months, 9 months, 12 months|||units on a scale||Standard Error|Mean
139211|NCT00475501|Secondary|Geriatric Depression Scale|"Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment.~The minimum score is 0 = no depressive symptoms The maximum score is 15 = a very high level of depressive symptoms"|baseline, 3 months, 6 months, 9 months, 12 months|||units on a scale||Standard Error|Mean
139212|NCT00475501|Secondary|Lumbar Spine L2-L4 Bone Mineral Density|Dual x-ray absorptiometry (DXA): We will assess bone mineral density (BMD) and body composition using a fan-bean densitometer (Lunar Prodigy, General Electric Medical Systems).|baseline, 12 months|||gm/cc||Standard Error|Mean
139213|NCT00475501|Secondary|Grip Strength kg|Grip strength in the dominant arm will be measured by using a dynamometer. Testing will be performed at baseline, after 3, 6, 9 and 12 months of treatment.|baseline, 3 months, 6 months, 9 months, 12 months|||kg||Standard Error|Mean
139214|NCT00475501|Primary|1 Repetition Maximum (1-RM) Strength Testing|1-RM strength testing for 5 exercises will be performed using dynamic resistance exercise machines. Testing will be performed before treatment (baseline), at 3, 6, 9 and 12 months after treatment.|baseline, 3 months, 6 months, 9 months, 12 months|per protocol||kg||Standard Error|Mean
139215|NCT00475423|Secondary|Change From Baseline in CD19 B Cell Count|Actual values of CD19+ mean B cell count assessed at Weeks 3 and 8, and Months 4, 6, 8, 10 and 12, and last day. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day|Safety Analysis Population; n=number of participants assessed for the specified parameter at a given visit.||10^9 cells/L||Standard Deviation|Mean
139216|NCT00475423|Secondary|Cluster of Differentiation 19 (CD19) B Cell Count|Value of mean CD19+ B cell count at baseline. The standard reference range for CD19 is 0.05 to 0.35 x10^9/L.|Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day|Safety Analysis Population; n (number) = number of participants assessed for the specified parameter at a given visit.||10^9 cells/L||Standard Deviation|Mean
139217|NCT00475423|Secondary|Percentage of Participants With a Therapeutic Response|Number of therapeutic responder participants by CR, PR, MR, or no response (NR) measured at Week 26 and Week 52. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR was defined as at least minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population||percentage participants||95% Confidence Interval|Number
139218|NCT00475423|Secondary|Percentage of Therapeutic Responders|Percentage of participants with a therapeutic response, defined as achieving CR, PR, or MR assessed at Week 26 and Week 52 or hematological response, defined as achieving CR, PR, or MR at Week 8. CR was defined as no platelet response or no reduction in the dose intensity of concomitant ITP therapy compared with that at screening. PR response was defined as at least a minor platelet response that enabled a 50% to 99% reduction in the dose intensity of concomitant ITP therapy compared with that at screening. MR was defined as at least a minor platelet response that enabled a 1% to 49% reduction in the dose intensity of concomitant ITP therapy compared with that at screening.|Week 26 and Week 52|ITTR Population||percentage of participants|||Number
139219|NCT00475423|Secondary|Time to Initiation of New ITP Therapy|Median time in days to initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
139220|NCT00475423|Secondary|Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event|Percentage of participants with an event of initiation of new ITP therapy and/or increase in dose of existing ITP therapy, including date on which decision made in relation to splenectomy, from time of first treatment to Week 52.|Week 52|ITTR Population||percentage of participants|||Number
139221|NCT00475423|Secondary|Duration of MR in Participants With Continued MR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of MR, irrespective of change of treatment. MR was defined as participants registered with ITP in relapse with a platelet count of > 30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50% to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population||days||95% Confidence Interval|Median
139222|NCT00475423|Secondary|Duration of PR in Participants With Continued PR From Week 8 Until Week 52|Duration of PR was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of PR, irrespective of change of treatment. PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population||days||95% Confidence Interval|Median
139223|NCT00475423|Secondary|Duration of CR in Participants With Continued CR From Week 8 Until Week 52|Duration of response was assessed in all responders who reached Week 8 and was defined as the time from Week 8 to the end of CR, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.||days||95% Confidence Interval|Median
139224|NCT00475423|Secondary|Percentage of Participants With Continued CR From Week 8 to Week 52|The number of participants with a durable CR assessed in CR responders whose responses were sustained from Week 8 through to the end of the study or withdrawal, irrespective of change of treatment. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 8 to Week 52|ITTR Population; only participants with a CR at Week 8 were included in the analysis.||percentage of participants|||Number
139225|NCT00475423|Secondary|Time to MR|Time to response was defined as the time from the first infusion to the first date on which MR was achieved. MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 percent (%) to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
139226|NCT00475423|Secondary|Percentage of Participants Who Achieved MR|MR was defined as participants registered with chronic ITP with a platelet count of >30x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with a 50 to 100% reduction in the dose intensity of concomitant ITP therapy compared with that at screening, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population||percentage of participants|||Number
139227|NCT00475423|Secondary|Time to PR|Time to response was defined as the time from the first infusion to the first date on which PR was achieved. PR was defined as platelet counts > 50x10^9/L over ≥ 2 consecutive measurements ≥ 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
139228|NCT00475423|Secondary|Percentage of Participants Who Achieved PR|PR was defined as platelet counts >50x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population||percentage of participants|||Number
139229|NCT00475423|Secondary|Time to CR|Time to CR was defined as the time from the first infusion to the first date on which CR was achieved. CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy. Participants without an event were censored at the date of last assessment.|Baseline to Week 52|ITTR Population||days||95% Confidence Interval|Median
139230|NCT00475423|Secondary|Percentage of Participants Who Achieved CR|CR was defined as platelet counts >150x10^9/L over ≥2 consecutive measurements ≥2 weeks apart, but no more than 60 days apart, and with no increase in concomitant ITP therapy or initiation of new ITP therapy.|Week 52|ITTR Population||percentage of participants|||Number
139231|NCT00475423|Secondary|Percentage of Participants With Hematological CR, PR, or Minor Response (MR)|Percentage of participants with CR, PR, and MR at Week 8 as evaluated by platelet count where CR is greater than or equal to (≥)150x10^9/L, PR ≥ 50x10^9/L, MR equals (=) 30x10^9/L over 2 consecutive measurements at least 2 weeks apart but no more than 60 days apart with no increase in concomitant therapy or initiation of new ITP therapy.|Week 8|ITTR Population||percentage of participants||95% Confidence Interval|Number
139232|NCT00475423|Primary|Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR)|Percentage of participants with an overall response at Week 8 achieving a CR or PR as evaluated by platelets, new or increased Idiopathic Thrombocytopenic Purpura (ITP)-related treatments and corticosteroids given for Adverse Events (AEs). CR was defined as a platelet count of greater than (>) 150x10^9/ liters (L) over at least 2 consecutive measurements at least 2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. PR was defined as platelet count of >50x10^9/L over at least 2 consecutive measurements at least <2 weeks apart, but no more than 60 days apart, with no increase in concomitant ITP therapy or initiation of new ITP therapy. Overall response rate (participants who achieved CR or confirmed PR) was evaluated using platelets, new or increased ITP related treatments, and corticosteroids given for AEs.|Week 8|Intent-to-Treat Replaced (ITTR) Population: participants who received at least 1 dose of study medication, excluded those lost to follow-up before completing treatment (reasons other than disease progression/toxicity) and/or those without documented platelet count of less than or equal to (≤)50x10^9/L within 7 days prior to 1st rituximab infusion.||percentage of participants||95% Confidence Interval|Number
139233|NCT00475332|Secondary|The Secondary Endpoint Will be to Assess Response Rates and Patterns of Failure in Patients Treated With Bexxar and External Beam Radiotherapy (EBRT).|Tumor response to treatment is measured using the RECIST criteria: Response Evaluation Criteria in Solid Tumors which defines Complete Response, Partial Response, Progressive Disease, and Stable Disease, by using tumor measurements as seen on CT or MRI|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.||Participants|||Number
139234|NCT00475332|Primary|The Primary Endpoint of the Study Will be to Determine the Feasibility of Combining External Beam Radiotherapy (EBRT) and Bexxar by Assessing the Toxicities Associated With the Treatment.|13 patients will be enrolled initially and followed for 3 months. If less than 10 of these patients reach a grade III or IV toxicity, then 12 more patients will be enrolled and the study will be deemed feasible. If 11 or more of the first group experience grade III/IV toxicity, the trial will stop early.|2 yr 3 mos|Two patients were enrolled and the study was terminated. No analyses were conducted.||Participants|||Number
139293|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|baseline|Participants who were ambulatory at baseline||meters per second||Standard Error|Mean
150390|NCT00385216|Primary|Pain Reported by Patient|Pain reported on the numerical rating scale for pain (NRS) with 0=no pain and 10=worst pain.|1 day|||Numeric Rating Scale (NRS)||Standard Deviation|Mean
139235|NCT00475319|Secondary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctival sac and the conjunctina was divided into 6 ractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-18). 0 is better. The CFB to each study time point was compared between the active-drug groups and the placebo group, and LOCF endpoint scores were used to compare the active-drug groups and the placebo group. In each treatment group, baseline scores and those obtained at each study time point were compared.|Baseline, 4weeks|||LGCS score||Standard Deviation|Mean
139236|NCT00475319|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated(0-15). 0 is better.The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 4weeks|||FCS score||Standard Deviation|Mean
139237|NCT00475306|Secondary|Number of Participants With Akathisia|The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness.|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see participant flow for details||participants|||Number
139238|NCT00475306|Primary|Nausea Scale|Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable|60 minutes|Only patients who received the investigational medication are included in this analysis. Please see the participant flow section for more details.||units on a scale||Inter-Quartile Range|Median
139239|NCT00475241|Secondary|All of Below Measures Are Taken at the Major Assessment Points.- Beck Depression Inventory-II- Depression Anxiety Stress Scale- Posttraumatic Cognitions Inventory- Client Satisfaction Questionnaire||pre, mid, post, 3 and 6 mo FU||||||
139240|NCT00475241|Secondary|HPA Axis Reactivity Will be Assessed With Collection of Salivary Cortisol at Each Major Assessment. Cortisol Response to Awakening, Our Measure of General Stress Reactivity, Will be Calculated.||pre, mid, post, 3 and 6 mo FU||||||
139241|NCT00475241|Secondary|Psychophysiological Reactivity Will be Assessed Using a Biopac MP-100 Physiology Recording System for Measurement of Heart Rate (Electrocardiography, ECG), Skin Conductance, Respiration, and End-tidal pCO2 (Pre, Mid, Posttreatment, 3 and 6 mo FU).||pre, mid, post, 3 and 6 mo FU||||||
139242|NCT00475241|Primary|Clinician Administered PTSD Scale (Pre & Posttreatment)|Clinician Adminstered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.|PostTreatment (Week 12)|Treatment Completers||units on a scale||Standard Deviation|Mean
139243|NCT00475176|Secondary|2-log Decline in HCV RNA by Week 12 (Early Virological Response) and Sustained Eradication of HCV RNA (Sustained Virological Response).|2-log decline in HCV RNA by week 12 (early virological response) and sustained eradication of HCV RNA (sustained virological response).|12 weeks from start of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.||participants|||Number
139244|NCT00475176|Primary|Improvement in Viral Kinetics During the First 2 Weeks of Therapy|Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy|Days 7 to 14 of therapy|Of 24 patients enrolled, 3 patients completed first course only due to adverse effects or personal reason. A fourth patient completed both courses but missed blood draws in both courses, precluding calculation of accurate first- and second-phase kinetic parameters. These 4 patient were excluded from analysis.||participants|||Number
139245|NCT00475150|Secondary|The Number of Patients That Report Adverse Events Possibly, Probably, or Definitely Related to AZD2171.|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All adverse events determined to be possibly, probably, or definately related to AZD2171 are included in this analysis.|Continuously during treatment up to 26 courses|All participants were analyzed for this endpoint.||participants|||Number
139246|NCT00475150|Secondary|Duration of Response|Measured from the time criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Estimated using the method of Kaplan-Meier.|Every 3 courses up to 26 courses|This endpoint was not analyzed due to lack of response.|||||
139247|NCT00475150|Secondary|Progression-free Survival|"Defined as the time from date of registration to date that disease progression was documented, death, or last date that progression-free status was documented, whichever comes first. Estimated using the method of Kaplan-Meier.~Disease progression is defined as one of the following:~A ≥ 50% increase in bone marrow blasts from the best response, or~A 50% or greater decrement from maximum remission/response levels in neutrophils or platelets, or~A reduction in hemoglobin concentration by at least 1.5 g/dl, or~Transfusion dependence (without alternative explanation and sustained for at least 2 weeks)."|Every 3 courses during treatment and then at 3 months and every 6 months for up to 2 years after completion of study treatment|All participants are evaluable for this primary endpoint.||months||95% Confidence Interval|Median
139248|NCT00475150|Secondary|Overall Survival|Defined as the time from date of registration to date of death due to any cause or date last known alive. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Every cycle during treatment and every 6 months for up to 2 years after completion of study treatment|All participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
139294|NCT00474812|Secondary|Median Progression Free Survival (PFS)|Number of months patients were free of disease progression, defined as < 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.|Up to 5 years|Intent to treat||months||95% Confidence Interval|Median
140411|NCT00465972|Secondary|Change in Piper Fatigue Scale at 3 Months|A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
139249|NCT00475150|Primary|The Number of Confirmed Disease Response: Complete Response (CR), Partial Response (PR), and Hematologic Improvement (HI). A Confirmed Response is Defined to be an Objective Status of CR, PR, or HI Noted on 2 Consecutive Evaluations.|"Complete Response (CR) requires a repeat bone marrow with < 5% myeloblasts, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.~Partial Response (PR) requires a bone marrow blast reduction of 50% or more, hemoglobin ≥ 11 g/dl, neutrophils ≥ 1000/mm3, platelets ≥ 100,000/mm3, and no circulating blasts.~Hematologic Improvement (HI) requires one of the following:~RBC transfusion independent participants are required to have >1.5 g/dL increase in hemoglobin,~RBC transfusion-dependent participants are required to be transfusion independent,~A 100% increase, and an absolute increase over 500mm^3 in Absolute Neutrophil Count,~Participants with a pretreatment platelet count over 20,000/mm3 require an absolute increase of 30,000/mm^3 or more,~Participants with platelet count below 20,000/mm3 require an increase over 20,000/mm^3 and by at least 100%."|At the end of cycles 1 and 3 and every 3 cycles thereafter up to 26 cycles|All participants were evaluable for this endpoint.||participants|||Number
139250|NCT00475085|Primary|Home Record: Severity of Delayed Nausea|1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse|average of day 1 afternoon, evening and night, and all of days 2 and 3|||units on a scale||Standard Deviation|Mean
139251|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139252|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139253|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139254|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Systemic Events in the 13vPnC and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep were reported using an electronic diary. Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population; N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139255|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (12 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139256|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (6 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139257|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (4 months of age)|Safety population; N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139258|NCT00475033|Other Pre-specified|Percentage of Subjects Reporting Pre-specified Local Reactions in the 13vPnC and 7vPnC Groups: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category.|Within 4 days after dose (2 months of age)|Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the 13vPnC and 7vPnC groups, respectively.||percentage of subjects|||Number
139259|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1.0 μg/mL for PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1.0 μg/mL along with the corresponding 95% CI for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration (titer) to the given antigen.||percentage of subjects||95% Confidence Interval|Number
139260|NCT00475033|Primary|Geometric Mean Concentration (GMC) of PRP in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of PRP in Hib as measured by µg/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMCs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMC µg/mL||95% Confidence Interval|Geometric Mean
139261|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥0.15 Micrograms Per mL (μg/mL) for Polyribosylribitol Phosphate (PRP) in Hib in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥0.15 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen PRP in Hib are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.||percentage of subjects||95% Confidence Interval|Number
139262|NCT00475033|Primary|Geometric Mean Concentration (GMC) of Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration of pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented. GMC and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence intervals on the ratio of the GMCs for 13vPnC relative to 7vPnC were constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the 3-dose Infant Series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration (titer) to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMC EU/mL||95% Confidence Interval|Geometric Mean
139263|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.||GMC μg/mL||95% Confidence Interval|Geometric Mean
139264|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentage of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.||percentage of subjects||95% Confidence Interval|Number
139265|NCT00475033|Other Pre-specified|Geometric Mean Concentration (GMC) for Pneumococcal IgG Antibody in 13vPnC Group After the 3-dose Infant Series|Antibody geometric mean concentration (GMC) as measured by μg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate antibody concentration for the given serotype for 13vPnC.||GMC μg/mL||95% Confidence Interval|Geometric Mean
139266|NCT00475033|Other Pre-specified|Percentage of Subjects Achieving Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 μg/mL in the 13vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with a determinate IgG antibody concentration to the given serotype for 13vPnC.||percentage of subjects||95% Confidence Interval|Number
139350|NCT00474630|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139267|NCT00475033|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the GMs for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after the toddler dose (13 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMT||95% Confidence Interval|Geometric Mean
139268|NCT00475033|Secondary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C SBA in the 13vPnC Group Relative to 7vPnC Group After the Toddler Dose of NeisVac-C®|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the toddler dose of NeisVac-C® (13 months of age)|The evaluable immunogenicity population was the primary analysis population. N=number of participants analyzed with a determinate post-toddler dose antibody concentration (titer) to the given antigen.||percentage of subjects||95% Confidence Interval|Number
139269|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level to Pertussis Antigens in the 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series|Percentage of subjects achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95 % CI for concomitant antigens pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) and ≥ 2.2 EU/mL fimbrial agglutinogens (FIM) are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after the 3-dose infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; (n)=number of participants with an antibody concentration (titer) ≥ to prespecified level for the given antigen for 13vPnC and 7vPnC, respectively.||percentage of subjects||95% Confidence Interval|Number
139270|NCT00475033|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Antibody geometric mean titer of meningococcal C antigen are presented. GMT and corresponding 2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution. In addition, the 2-sided 95% confidence interval on the ratio of the geometric means for 13vPnC relative to 7vPnC was constructed by back transformation of the Student t distribution for the mean difference of the measures on the logarithmic scale.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|The evaluable immunogenicity population was the primary analysis population; N=number of participants analyzed with a determinate antibody titer to the given antigen. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.||GMT||95% Confidence Interval|Geometric Mean
139271|NCT00475033|Primary|Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Meningococcal C Serum Bactericidal Assay (SBA) in the 13vPnC Group Relative to 7vPnC Group After 2 Doses of NeisVac-C® in the Infant Series|Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95 percent (%) confidence interval (CI) for concomitant antigen meningococcal C SBA are presented. Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups > -10%.|1 month after 2 doses of NeisVac-C® in the infant series (7 months of age)|Evaluable immunogenicity population: had treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants analyzed with a determinate post-infant series antibody concentration to the given antigen.||percentage of subjects||95% Confidence Interval|Number
139272|NCT00474994|Primary|Overall Objective Response|as assessed by RECIST criteria|2 years|||participants|||Number
139273|NCT00474968|Primary|Specimen Adequacy|Number and percentage of samples classified as adequate for diagnosis|At time of cell collection|Includes all cytology specimens||Participants|||Number
139274|NCT00474968|Secondary|Human Papilloma Virus (HPV) Detection Frequency|Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay|At the time of cell collection.|||Participants|||Number
139275|NCT00474968|Primary|Cell Collection Efficacy|True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.|At the time of cell collection.|79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported||Participants|||Number
139276|NCT00474955|Secondary|Mean Change From Baseline in Heart Rate up to Week 72|Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.||Beats per minute (bpm)||Standard Deviation|Mean
139277|NCT00474955|Secondary|Mean Change From Baseline in Blood Pressure up to Week 72|Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|From Baseline (Days -30 to -1) to Week 72|ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by ‘n’.||Millimeter (mm) of Mercury||Standard Deviation|Mean
150413|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
139278|NCT00474955|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks|Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).|Up to Week 72|ITT population included all enrolled participants who received at least one dose of study medication.||Participants|||Number
139279|NCT00474955|Secondary|Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks|Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.|Up to Week 48|ITT population included all enrolled participants who received at least one dose of study medication.||Participants|||Number
139280|NCT00474955|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Week 72|Safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.||Participants|||Number
139281|NCT00474955|Primary|Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline|The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]).|From Baseline (Days -30 to -1) and Week 24|ITT population included all enrolled participants who received at least one dose of study medication.||Percentage of participants|||Number
139282|NCT00474955|Primary|Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48|HCV RNA level less than 50 IU/mL was considered to be undetectable.|At Week 24 and Week 48|ITT population included all enrolled participants who received at least one dose of study medication.||Percentage of participants|||Number
139283|NCT00474955|Primary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion|Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).|At Week 72|ITT population included all enrolled participants who received at least one dose of study medication.||Percentage of participants|||Number
139284|NCT00474929|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date documentation of disease progression or death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
139285|NCT00474929|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration|||months||95% Confidence Interval|Median
139286|NCT00474929|Primary|Proportion of Confirmed Tumor Responses|"A confirmed response is defined to be a CR or PR noted as the objective status for eligible patients during cycles 1-12.~Complete Response (CR):~Multiple Myeloma (MM): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and normalization of free light chain (FLC) ratio.~Lymphoma: Disappearance of all clinical and radiographic evidence of disease, all lymph nodes of normal size (1.5 cm or less), no splenomegaly.~Partial Response (PR):~MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma.~Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline."|Up to 12 cycles of treatment|||percentage of participants|||Number
139287|NCT00474929|Primary|Number of Participants Reporting a Dose Limiting Toxicity (DLT)|"The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). Dose-limiting toxicity (DLT) is defined as an adverse event attributed (definitely, probably, or possibly) in first cycle to the study treatment and meeting the following criteria:~Grade 4 infection~Grade 4 ANC or PLT~Grade 3 or higher non-hematologic adverse event.~NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 will be used to assess adverse events. For this endpoint, the number of patients reporting a DLT event are tabulated."|First cycle (28 days) of study treatment|||participants|||Number
139288|NCT00474903|Secondary|Toxicity|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the interventional agent, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of patients reporting adverse events will be tabulated by grade.|Up to 30 days after completion of study treatment|All 120 patients that took study medication were evaluable for this secondary endpoint.||participants|||Number
139289|NCT00474903|Primary|Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples|The mean tissue PGE2 is reported for each Arm.|Baseline to 30 days after completion of study treatment|||pg/mL||Standard Deviation|Mean
139290|NCT00474851|Secondary|Total Body Bone Mineral Content (BMC)||Baseline to 12 months|||g||Standard Error|Mean
139291|NCT00474851|Primary|Bone Mineral Density|Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial|Baseline to 12 months|||g/cm^2||Standard Error|Mean
139292|NCT00474812|Secondary|Gait Speed|Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.|at 8 weeks|Participants who were ambulatory at 8 weeks||meters per second||Standard Error|Mean
139295|NCT00474812|Secondary|Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee|Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.|Up to 5 years|Patients that reached first scans at 2 months||participants|||Number
139296|NCT00474812|Primary|Median Overall Survival|From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months|assessed up to 24 months|Intent to treat.||months||95% Confidence Interval|Median
139297|NCT00474786|Other Pre-specified|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 24 months|Safety population: all participants who received at least 1 dose of test article.||participants|||Number
139298|NCT00474786|Secondary|Duration of Response (DR)|Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method.|Baseline up to 24 Months|ITT population||months||95% Confidence Interval|Median
139299|NCT00474786|Secondary|Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment|PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7.|Weeks 12, 24, and 36|ITT population||percentage of participants|||Number
139300|NCT00474786|Secondary|Overall Survival (OS)|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death from any cause (up to 24 months)|ITT population||months||95% Confidence Interval|Median
139301|NCT00474786|Secondary|Percentage of Participants With Tumor Response|Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline up to 24 Months|ITT population||percentage of participants||95% Confidence Interval|Number
139302|NCT00474786|Secondary|Progression Free Survival (PFS) by Investigator Assessment|Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first.|Baseline up to 24 Months|ITT population||months||95% Confidence Interval|Median
139303|NCT00474786|Primary|Progression-Free Survival (PFS)|Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.|Baseline up to 24 Months|Intent to Treat Population (ITT): all randomized participants according to their assigned treatment, regardless of whether they were received any study drug.||months||95% Confidence Interval|Median
139304|NCT00474760|Secondary|Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs|Quantification of IGF-IR positive CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment IGF-1R positive CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.|||||
139305|NCT00474760|Secondary|Number of Circulating Tumor Cells (CTCs)|Quantification of CTCs using an automated microscope system|30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort|Pretreatment CTCs were detected in an insufficient number of participants to analyze for any treatment effect on this pharmacodynamic biomarker.|||||
139306|NCT00474760|Secondary|Human Anti-human Antibodies (HAHA) Levels|HAHA were indicators of immunogenicity to figitumumab.|30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)|Per protocol, the presence of HAHA would only be evaluated for those samples with plasma figitumumab concentrations below the limit of quantification (BLQ). Since none of the postdose samples in the study had figitumumab concentrations BLQ, therefore no sample was analyzed for HAHA.|||||
139307|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure||mg*hr/L||Standard Deviation|Mean
139308|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in RP2D ESFT extension cohort. N=number of participants evaluable for the outcome measure||mg*hr/L||Standard Deviation|Mean
139309|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
139351|NCT00474630|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
139310|NCT00474760|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in all cohorts except ESFT extension cohort. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
139311|NCT00474760|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1|Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
139312|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg*hr/L||Standard Deviation|Mean
139313|NCT00474760|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milligram*hour/liter (mg*hr/L)||Standard Deviation|Mean
139314|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/kg||Standard Deviation|Mean
139315|NCT00474760|Secondary|Volume of Distribution at Steady State (Vss) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/kg||Standard Deviation|Mean
139316|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/kg||Standard Deviation|Mean
139317|NCT00474760|Secondary|Volume of Distribution (Vz) in Cycle 1|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milliliter/kilogram (mL/kg)||Standard Deviation|Mean
139318|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg/L||Standard Deviation|Mean
139319|NCT00474760|Secondary|Concentration at End of Infusion (Cendinf) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg/L||Standard Deviation|Mean
139320|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mL/day/kg||Standard Deviation|Mean
139321|NCT00474760|Secondary|Systemic Clearance (CL) in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
139322|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
139323|NCT00474760|Secondary|Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
139324|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
139325|NCT00474760|Secondary|Plasma Decay Half-Life (t1/2) in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
139326|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
139327|NCT00474760|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||hours||Standard Deviation|Mean
139328|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 4||Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the PK parameters of primary interest in extension cohorts. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||mg/L||Standard Deviation|Mean
139329|NCT00474760|Secondary|Maximum Observed Plasma Concentration (Cmax) in Cycle 1||Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest. N=number of participants evaluable for the outcome measure. Summaries for figitumumab 20 mg/kg RP2D, and figitumumab 20 mg/kg RP2D ACC and sarcoma extension cohorts were combined into 1 reporting group: figitumumab 20 mg/kg RP2D every 3 weeks.||milligram/liter (mg/L)||Standard Deviation|Mean
139330|NCT00474760|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 150 days after the last administration of study drug|All enrolled participants who started treatment.||participants|||Number
139331|NCT00474708|Secondary|Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment. A total of 125 (VEN XR=83, SSRI=42) patients had a co-morbid anxiety disorder and 834 (VEN XR=581, SSRI=253) did not.||participants|||Number
139332|NCT00474708|Primary|Number of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.|12 weeks|The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment.||participants|||Number
139333|NCT00474630|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
139334|NCT00474630|Secondary|Change in Food Craving Inventory Sweets Subscale Score|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
139335|NCT00474630|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
139336|NCT00474630|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
139337|NCT00474630|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mm Hg||Standard Error|Least Squares Mean
139338|NCT00474630|Secondary|Change in Fasting LDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
139339|NCT00474630|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
139340|NCT00474630|Secondary|Percent of Subjects Discontinuing Due to Poor Glycemic Control|Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed. Odds ratio not calculated as there were no subjects in the NB32 group that discontinued due to poor glycemic control.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139341|NCT00474630|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
139342|NCT00474630|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
139343|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <6.5% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139344|NCT00474630|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
139345|NCT00474630|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
139346|NCT00474630|Secondary|Percent of Subjects With Dose Increase in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139347|NCT00474630|Secondary|Percent of Subjects With Dose Reduction in Oral Antidiabetes Medications||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139348|NCT00474630|Secondary|Percent of Subjects Requiring Rescue Medications for Diabetes||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139349|NCT00474630|Secondary|HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139354|NCT00474630|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
139355|NCT00474630|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
139356|NCT00474630|Secondary|Change in HbA1c Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent||Standard Error|Least Squares Mean
139357|NCT00474630|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
139358|NCT00474539|Secondary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after toddler dose (at 16 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate IgG antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
139359|NCT00474539|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
139360|NCT00474539|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
139361|NCT00474539|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose||One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
139362|NCT00474539|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose|Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).|One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable 3-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
139363|NCT00474539|Primary|Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose||One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)|The evaluable 2-dose immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
139364|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
139380|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139365|NCT00474539|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
139366|NCT00474539|Primary|Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series|Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.|One month after infant series dose (at 5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component.||percentage of participants||95% Confidence Interval|Number
139367|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
139368|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 15 months of age (one month post 1st or 2nd toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139369|NCT00474526|Secondary|Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
139370|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens|17 months of age (one month post-toddler vaccination)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
139371|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F|13 months of age (one month post-toddler vaccination)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
139372|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination – LA Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol||Concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
139373|NCT00474526|Secondary|Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
139374|NCT00474526|Secondary|Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects|Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.|13 months of age (one month post-toddler vaccination)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
139375|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
139376|NCT00474526|Secondary|Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139377|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139378|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.|13 or 17 Months of Age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139379|NCT00474526|Secondary|Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
139381|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139382|NCT00474526|Secondary|Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects|Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139383|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
139384|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139385|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 or 16 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Percentages of subjects||95% Confidence Interval|Number
139386|NCT00474526|Secondary|Persistence Antibodies Geometric Mean Titers – US Subject|Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.|12 Months of Age (one month pre-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
139387|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"||Percentages of subjects||95% Confidence Interval|Number
139388|NCT00474526|Secondary|Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject|Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.|12 Months of Age (one month pre-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"||Percentages of subjects||95% Confidence Interval|Number
139389|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
139390|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
139391|NCT00474526|Secondary|Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Percentages of subjects||95% Confidence Interval|Number
139392|NCT00474526|Secondary|Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects|Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.|7 months of age (one month post-infant series)|Per Protocol||Titers||95% Confidence Interval|Geometric Mean
139393|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population||Percentages of subjects||95% Confidence Interval|Number
139394|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .|7 months of age (one month post-infant series)|Per protocol population||Percentages of subjects||95% Confidence Interval|Number
139395|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:4 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population||Percentages of subjects||95% Confidence Interval|Number
139396|NCT00474526|Secondary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|Per Protocol Population||Percentages of subjects||95% Confidence Interval|Number
139397|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - LA Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.|7 months of age (one month post-infant series)|Per protocol population||Titer||95% Confidence Interval|Geometric Mean
139398|NCT00474526|Secondary|Geometric Mean hSBA Titers Post-infant Series - US Subjects|Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.|7 months of age (one month post-infant series)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
139399|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination – Infant Series|Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the third dose in the infant series were included in this analysis.||Subjects|||Number
139400|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Infant Series|Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose of the infant series vaccination were included in the analysis.||Subjects|||Number
139401|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Infant Series|Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.|7 days post-vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
139402|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Toddler Series|Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. Only subjects who received the second dose at 15 months were included in this analysis.||Subjects|||Number
139403|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Toddler Series|Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days post vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
139404|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age|Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
139405|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination – Infant Series|Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals.||Subjects|||Number
139406|NCT00474526|Primary|Geometric Mean hSBA Titers – US Subjects|Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.|13 months of age (one month post-toddler vaccination)|The analysis was done on per protocol population||Titers||95% Confidence Interval|Geometric Mean
139407|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination – Infant Series|Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set: The total number of subjects analyzed was less than the safety set due to subject withdrawals. LA1 and LA 2 groups are not included here as they did not receive MenACWY at 4 months of age.||Subjects|||Number
139408|NCT00474526|Secondary|Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination – Infant Series|Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.|7 days after vaccination|The population used in analysis was the safety set Safety population was defined as: all subjects in the exposed population who provided post-baseline safety data. If a subject received an entirely wrong vaccine schedule (e.g., US3 instead of US4), the subject would be analyzed for safety according to the group the subject actually followed.||Subjects|||Number
139409|NCT00474526|Primary|Percentage of Subjects With hSBA Titer >=1:8 - US Subjects|Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age|13 months of age (one month post-toddler vaccination)|"The analysis was done on per protocol population~Per protocol was defined as subjects who:~received all the relevant doses of vaccine correctly~provided evaluable serum samples at the relevant time points~had no major protocol deviation as defined prior to database lock"||Percentages of subjects||95% Confidence Interval|Number
139410|NCT00474487|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years|Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).|Days 1 to 7|The analysis was done on the safety population.||Subjects|||Number
148151|NCT00402740|Secondary|Acute Device Success|Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.|Post-procedure|ITT||percentage of participants||95% Confidence Interval|Number
139412|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
139413|NCT00474487|Secondary|Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population|Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
139414|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).~Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
139415|NCT00474487|Secondary|Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population|"Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).~Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month postvaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Number
139416|NCT00474487|Primary|Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years|Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.|Days 1 to 7|The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.||Subjects|||Number
139417|NCT00474383|Secondary|Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)|The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study.||participants|||Number
139418|NCT00474383|Secondary|Overall Survival|Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.|Baseline until death, or end of study (Week 148)|The ITT population included all the participants who were enrolled into the study.||days||95% Confidence Interval|Median
139419|NCT00474383|Secondary|Progression Free Survival Time|Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.||days||95% Confidence Interval|Median
139420|NCT00474383|Secondary|Duration of PSA Response|Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.||days||95% Confidence Interval|Median
139421|NCT00474383|Secondary|Time to PSA Progression|The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.|Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)|The ITT population included all the participants who were enrolled into the study.||days||95% Confidence Interval|Median
139439|NCT00474175|Secondary|Duration of Effect|Duration of effect was defined as the time difference between onset of effect and its offset. Onset of effect was the first time point at which two consecutive pain scores less severe than at baseline by at least 1 unit (on the DPS) were attained. Offset of effect was the first of the following events to occur after onset: time to drop out if the drop out was due to lack of efficacy, time of rescue medication, or the first time point following onset of effect at which two consecutive pain scores that are at least as severe as at baseline were attained.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
139422|NCT00474383|Secondary|Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)|The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.|Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)|The ITT population included all the participants who were enrolled into the study. Here 'N' (number of participants analyzed) signifies evaluable participants with measurable disease (the presence of at least one measurable lesion) at Baseline.||percentage of participants||95% Confidence Interval|Number
139423|NCT00474383|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline up to Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
139424|NCT00474383|Primary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.|Baseline, Week 12|The Intent-to-treat (ITT) population included all the participants who were enrolled into the study.||percentage of participants||95% Confidence Interval|Number
139425|NCT00474240|Secondary|Percent Change From Baseline of Other Lipids||After 8 weeks of study drug|Intent To Treat||Percent||Standard Deviation|Mean
139426|NCT00474240|Primary|Percent Change From Baseline in LDL-C at 8 Weeks||Atfer 8 weeks on study drug|Intent To Treat||Percent Change||Standard Deviation|Mean
139427|NCT00474201|Primary|Gemfibrozil Area Under the Concentration vs. Time Curve (AUC)|AUC (ng*hr/mL) of gemfibrozil when given as a 600 mg dose by itself compared to gemfibrozil AUC after 14.5 days of lopinavir-ritonavir (400mg/100mg) twice daily.|22 days per subject (approximately 1 year for entire study completion)|Fifteen healthy volunteers were enrolled in this protocol based on an a priori power analysis. All 15 subjects completed the protocol and results reported are those from all 15 participants.||ng*hr/mL||90% Confidence Interval|Geometric Mean
139428|NCT00474188|Secondary|Progression-free Survival|"Time from the start of study drug therapy to the first observation of disease progression or death due to any cause.~Study terminated prematurely. Analysis not conducted."|One year|||Days||95% Confidence Interval|Median
139429|NCT00474188|Secondary|Time to Progression|"Time from the start of study drug therapy to the first documentation of disease progression.~Study terminated prematurely. Analysis not conducted."|One year|||Days||95% Confidence Interval|Median
139430|NCT00474188|Secondary|Duration of Response|"Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma.~Study terminated prematurely. Analysis not conducted."|One year|||Days||95% Confidence Interval|Median
139431|NCT00474188|Secondary|Tumor Control Rate|"Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.~Study terminated prematurely. Analysis not conducted."|One Year|||Participants||95% Confidence Interval|Mean
139432|NCT00474188|Primary|Tumor Response Rate|"Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53).~Study terminated prematurely. Analysis not conducted."|One Year|Study terminated prematurely. Analyses of efficacy not conducted.||Participants||95% Confidence Interval|Mean
139433|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication||Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.||Percentage of participants||95% Confidence Interval|Number
139434|NCT00474175|Other Pre-specified|Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied|Amount of study medication applied was calculated by weighing medication tube prior and post-dosing.|Baseline and 5 minutes|Safety population included all participants who received at least 1 dose of study medication and had follow up data.||Milligram (mg)||Standard Deviation|Mean
139435|NCT00474175|Secondary|Global Satisfaction Assessment|Participants were asked to provide an overall assessment of their satisfaction with the study medication on a categorical scale. Response in this scale was assigned values as 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent).|120 minutes|ITT population included all randomized participants who received study medication.||Units on a scale||Standard Deviation|Mean
139436|NCT00474175|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores|PRID is sum of PID and DPRS scores at each post-dosing time point. The overall possible score range, for PRID is -1 (worst) to 7 (best). PID was calculated as baseline DPS minus DPS score at given time point (DPS range from 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|5 to 120 minutes|ITT population included all randomized participants who received study medication.||Units on a scale||Standard Deviation|Mean
139437|NCT00474175|Secondary|Time to Dropping Out Due to Lack of Efficacy or Rescue Medication|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication (ibuprofen 200-400 mg or acetaminophen 1000 mg), whichever comes first.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
139438|NCT00474175|Secondary|Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores|SPRID is time-weighted sum of pain relief scores combined with pain intensity difference (PRID) scores over 60 and 120 minutes. SPRID score range was 0 (worst) to 7 (best) for SPRID 60 and 0 (worst) to 14 (best) for SPRID 120. PRID is sum of Pain intensity differences (PID) and Dental pain relief scale (DPRS) scores at each post-dosing time point. PID was calculated as baseline DPS minus DPS score at given time point (DPS range: 0 [none] to 3 [severe]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).|60 minutes and 120 minutes|ITT population included all randomized participants who received study medication.||Units on a scale||Standard Deviation|Mean
139440|NCT00474175|Secondary|Time to Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
139441|NCT00474175|Secondary|Time to First Confirmed Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.|0 to 120 minutes|ITT population included all randomized participants who received study medication.||Minutes||95% Confidence Interval|Median
139442|NCT00474175|Primary|Percentage of Participants With a Response|Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).|Baseline, 5, 10, 15 and 20 minutes|Intent to treat (ITT) population included all randomized participants who received study medication.||Percentage of participants|||Number
139443|NCT00474123|Secondary|Endothelial Progenitor Cells|Endothelial progenitor cells were evaluated by flow cytometry. Selected cells were positive for CD31, CD34 and VEGFR receptors.|Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.|||percentage||Standard Deviation|Mean
139444|NCT00474123|Secondary|Triglyceride||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.|||percentage||Standard Deviation|Mean
139445|NCT00474123|Secondary|LDL Cholesterol||Fasting venous blood samples were drawn immediately after randomization and at the conclusions of the six week study period.|||percentage||Standard Deviation|Mean
139446|NCT00474123|Primary|Interleukin-6|A commercial ELISA assay detecting IL-6 (Siemens, USA) was applied.|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.|||percentage||Inter-Quartile Range|Median
139447|NCT00474123|Primary|Soluble CD40 Ligand|A commercial ELISA assay detecting sCD40L (R&D Systems, USA) was applied. Detection limits and intra-assay variability was respectively, as follows: sCD-40L 15.6 pg/mL (intra-assay variability not available).|Fasting venous blood samples were drawn immediately after randomization and after at the conclusions of the six weeks study period.|||percentage||Standard Deviation|Mean
139448|NCT00474123|Primary|Soluble Intercellular Adhesion Molecule (sICAM)-1|serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK)|Change from baseline at 6 weeks|per protocol||percentage||Standard Deviation|Mean
139449|NCT00474123|Primary|Monocyte Chemoattractant Protein (MCP)-1|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting MCP-1/ICAM-1 (R&D Systems, Europe, Abingdon, UK).|Change from baseline at 6 weeks|per protocol||percentage||Standard Deviation|Mean
139450|NCT00474123|Primary|Platelet Function Analyzer [PFA]-100|Samples were collected in 3.8% sodium citrate (buffered, pH 5.5, Vacutainer, Becton Dickinson, Plymouth, UK) for platelet function tests. Platelet function assays were processed within 2 hours of blood collection. The PFA-100 records the closure time (CT), witch means the time in seconds (s) from the start of the test until the platelet plug occludes the aperture.|Change from baseline at 6 weeks|per protocol||Percentage||Standard Deviation|Mean
139451|NCT00474123|Primary|Oxidized Low-Density Lipoprotein Cholesterol|Serum samples were stored at -70°C and were determined simultaneously by ELISA in order to avoid variation of assay conditions. Commercial ELISA assays detecting oxLDL (Mercodia, USA) were applied.|Change from baseline at 6 weeks|per protocol||Percentage||Standard Deviation|Mean
139452|NCT00474123|Primary|C-reactive Protein|Serum was separated by centrifugation from the blood samples. For high-sensitivity C-Reactive Protein measurement, whole venous blood was collected in tubes without anticoagulant and centrifuged at room temperature. Serum C-Reactive Protein was assessed with a high-sensitivity, latex microparticle-enhanced immunoturbidimetric assay (Behring Nephelometer Analyzer System; Behring Diagnostics, Somerville, NJ).|Change from baseline at 6 weeks|per protocol||Percentage||Inter-Quartile Range|Median
139453|NCT00474058|Secondary|Change in Number of Nocturias|Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).||nocturias||Standard Deviation|Mean
139454|NCT00474058|Secondary|Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)|Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS).||units on a scale||Standard Deviation|Mean
139455|NCT00474058|Primary|Change in Parkinson's Disease Sleep Scale (PDSS)|The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
139456|NCT00474058|Primary|Change in Early Morning UPDRS Part III Score|The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.|From baseline to end of maintenance (after 4 weeks maintenance)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
148424|NCT00400712|Primary|Subjective Index of Social Integration (Subscale of SIPSO)|see Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing||points on a scale||Standard Deviation|Mean
139457|NCT00474045|Secondary|Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||ratio||Full Range|Median
139458|NCT00474045|Secondary|Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||ratio||Full Range|Median
139459|NCT00474045|Secondary|Safety - Composite Pregnancy Outcome|Wt. corresponds to weight of live-born infants. Pre-term delivery: delivery before 37 completed GWs including abortions. Early foetal death: death before 22 completed GWs. Perinatal mortality: death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal mortality: post-partum after 7 completed days and before 28 completed days after delivery. Major-malformation: a life threatening structural anomaly or one likely to cause significant impairment of health or functional capacity and needs medical or surgical treatment.|End of Pregnancy|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and pregnant during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became pregnant again).||participants|||Number
139460|NCT00474045|Secondary|Safety - Total Daily Insulin Dose During Pregnancy||Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||U/kg||Standard Deviation|Mean
139461|NCT00474045|Secondary|Pregnancy Outcome at Follow-Up|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Perinatal Death means death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal Death means death between at or after 7 completed days and before 28 completed days after delivery. Death During Follow-Up means death between at or after 28 days after delivery and at or before Follow-Up.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.||participants|||Number
139462|NCT00474045|Secondary|Pregnancy Outcome at Delivery|Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Stillbirth indicates death between at or after 22 GW and at or before delivery.|Delivery Visit|Safety analysis set (pregnant subjects): randomised subjects exposed to at least 1 dose of trial product and preg. during the trial. IDet (N)=152 (152 pregnancies) NPH (N)=158 subjects (160 pregnancies, 2 subjects had spontaneous abortion and became preg. again). Analysed subjects-no. of subjects with a preg. outcome at delivery visit.||participants|||Number
139463|NCT00474045|Secondary|Maternal Safety - Mode of Delivery|Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery.|At Delivery Visit|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. This set in total contains 152 subjects in IDet and 158 subjects in NPH arm. The partcipant analysed for this outcome measure are the number of subjects at delivery visit.||percentage (%) of subjects|||Number
139464|NCT00474045|Secondary|Maternal Safety - Acceleration of Nephropathy|Acceleration of nephropathy was defined as a change from a low U-albumin:U-creatinine ratio ≤33.93 mg/mmol to a high U-albumin:U-creatinine ratio > 33.93 mg/mmol from GW 8-12 (Visit P1) to the follow-up visit.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of nephropathy was summarised by treatment and missing data was imputed using LOCF.||participants|||Number
139465|NCT00474045|Secondary|Maternal Safety - Acceleration of Retinopathy in Any Eye|Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes.|From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Acceleration of retinopathy was summarised by treatment and missing data was imputed using LOCF.||participants|||Number
139466|NCT00474045|Secondary|Maternal Safety - Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' (at Visit 1, 3 weeks before randomisation) to 'Abnormal, clinically significant' (at Follow-Up). 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Follow-Up (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||participants|||Number
139467|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up|Change in the pulse was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||beats/minute||Standard Deviation|Mean
139468|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the diastolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||mmHg||Standard Deviation|Mean
139943|NCT00468728|Secondary|Global Cure|Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.|End of Study|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.||Percentage of Participants|||Number
139469|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit|Change in the systolic blood pressure was summarised by treatment.|Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||mmHg||Standard Deviation|Mean
139470|NCT00474045|Secondary|Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit|Change in the body weight was summarised by treatment.|Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing values were imputed using LOCF.||kg||Standard Deviation|Mean
139471|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood||At Delivery|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. IDet in cord blood was analysed for subjects in the IDet Arm and only for 98 subjects, as for 72 subjects it was reported as below measuring range (<25.00 pmol/L).||pmol/L||Full Range|Median
139472|NCT00474045|Secondary|Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies|Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)|At Delivery (End of Pregnancy) and at Visit P4 (GW 36)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||ratio||Full Range|Median
139473|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
139474|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T)|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
139475|NCT00474045|Secondary|Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood|Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).|At Delivery (End of Pregnancy)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
139476|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies|Change in concentrations values for insulin detemir/aspart cross-reacting antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
139477|NCT00474045|Secondary|Maternal Safety - Change in Insulin Aspart Specific Antibodies|Change in concentrations values for insulin aspart specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
139478|NCT00474045|Secondary|Maternal Safety - Change in Insulin Detemir Specific Antibodies|Change in concentrations of values for insulin detemir specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.|Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||%B/T||Full Range|Median
139479|NCT00474045|Secondary|Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mg/dL||Standard Deviation|Mean
139480|NCT00474045|Secondary|Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mg/mmol||Standard Deviation|Mean
139481|NCT00474045|Secondary|Maternal Safety - Change in Urine Albumin Level (Urinalysis)|This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||g/dL||Standard Deviation|Mean
139482|NCT00474045|Secondary|Maternal Safety - Change in Thrombocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||10^9 cells/L||Standard Deviation|Mean
139483|NCT00474045|Secondary|Maternal Safety - Change in Leukocytes Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||10^9 cells/L||Standard Deviation|Mean
139484|NCT00474045|Secondary|Maternal Safety - Change in Haemoglobin Level (Haematology)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
139485|NCT00474045|Secondary|Maternal Safety - Change in Total Protein Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.Missing data was imputed using LOCF.||g/dL||Standard Deviation|Mean
139486|NCT00474045|Secondary|Maternal Safety - Change in Sodium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
139487|NCT00474045|Secondary|Maternal Safety - Change in Potassium Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mmol/L||Standard Deviation|Mean
139488|NCT00474045|Secondary|Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||U/L||Standard Deviation|Mean
139489|NCT00474045|Secondary|Maternal Safety - Change in Creatinine Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||mcmol/L||Standard Deviation|Mean
139490|NCT00474045|Secondary|Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||U/L||Standard Deviation|Mean
139491|NCT00474045|Secondary|Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||U/L||Standard Deviation|Mean
139492|NCT00474045|Secondary|Maternal Safety - Change in Albumin Serum Level (Biochemistry)|This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery).|Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Missing data was imputed using LOCF.||g/dL||Standard Deviation|Mean
139493|NCT00474045|Secondary|Maternal Safety - Nocturnal Hypoglycaemic Episodes|A nocturnal episode is any episode occurring between 0.01 - 5.59, both including. It includes major, minor and symptoms only episodes. Major: unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||episodes|||Number
139494|NCT00474045|Secondary|Maternal Safety - Hypoglycaemic Episodes|All episodes include major, minor and symptoms only. Major episode : unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. Diurnal: Episode occurring between 06.00 - 00.00, both including.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||episodes|||Number
139495|NCT00474045|Secondary|Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. SAE=any undesirable serious medical event as defined in protocol.|Foetuses/Newborns were followed during the pregnancy period, an average of 9.6 months and Follow-Up period (6 weeks after delivery)|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial. Each pregnant woman analyzed had exactly one Foetus/Newborn that was analyzed for AEs.||Foetus/Newborns (1 per pregnant woman)|||Number
139496|NCT00474045|Secondary|Maternal Safety - Number of Subjects With Adverse Events (AEs)|AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. Serious adverse event (SAE) =any undesirable serious medical event as defined in protocol.|Participants were followed during the pregnancy period, an average of 9.6 months|Safety analysis set (pregnant subjects): all randomised subjects who were exposed to at least one dose of trial product and who were pregnant during the trial.||participants|||Number
139497|NCT00474045|Secondary|8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P4 (GW 36)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.||mmol/L||Standard Deviation|Mean
139498|NCT00474045|Secondary|8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24|8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.|Visit P3 (GW 24)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 & NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the average values.||mmol/L||Standard Deviation|Mean
139499|NCT00474045|Secondary|Fasting Plasma Glucose (FPG)||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.||mmol/L||Standard Deviation|Mean
139500|NCT00474045|Secondary|Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36||At both Visit P3 (GW 24) and Visit P4 (GW 36)|FAS for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using LOCF which was made using pregnancy visits, early termination visit and withdrawal visit. Analysed subjects-subjects with valid HbA1c values at visit P3 and P4.||participants|||Number
139501|NCT00474045|Secondary|Glycosylated Haemoglobin (HbA1c) During Pregnancy||During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
139502|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Per Protocol Analysis Set (pregnant subjects): comprised all subjects from the FAS (pregnant subjects) except subjects who significantly violated the inclusion/exclusion criteria. Gestational age at delivery must be at least 32 completed weeks.||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
139503|NCT00474045|Primary|Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36||At gestational week (GW) 36|Full Analysis Set (FAS) for pregnant subjects-all randomised subjects exposed to at least 1 dose of trial drug and pregnant during trial. IDet (N)=152 and NPH (N)=158. Missing values were imputed using Last observation carried forward (LOCF). For FAS, LOCF was made using the pregnancy visits, the early termination visit and the withdrawal visit.||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
139504|NCT00473889|Secondary|Number of Participants Who Had a Disease Response to Treatment|Response to treatment is defined as a complete response (CR) or partial response (PR) to treatment. Confirmation of response required a second assessment performed at least 4 weeks after the initial assessment. (PR is defined as at least a 30% reduction in sum of the longest diameter of all target lesions and no increase in non-target lesions).|Every 42 days from start of treatment until disease response|"Full analysis set~(FAS) population is defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study. Five (5) didn't take any study medication. Therefore, 248 participants are included in this analysis population."||Participants|||Number
139505|NCT00473889|Secondary|Progression Free Survival|Defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in sum of the longest diameter of all target lesions, the appearance of a new lesion, or an increase in non-target lesions.|Start of treatment to disease progression or death|"Full analysis set~(FAS) population defined as all randomized participants who have received at least one dose of study medication. There are 253 participants randomized in the study 5 didn't take any study medication. Therefore, 248 participants are included in this analysis population."||Months||Full Range|Median
139506|NCT00473889|Primary|Overall Survival|Defined as the time from date of randomization to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.|Start of treatment to death|Intention-to-treat (ITT) population is defined as all randomized participants. Participants are counted in the group to which they are randomized.||Months||Full Range|Median
139507|NCT00473876|Secondary|Possible Mechanisms That Can Explain the Improvement of Exercise Capacity|VE/VCO2 Slope, measurement of the abnormal ventilatory response to exercise identified by an increased slope of ventilation (L/min) vs. CO2 production (VE/VCO2) (L/min) to incremental workload|4 months|39 patients were randomized with 3 dropped out. Therefore, 36 were included in the analysis. There was 1 patient who dropped out in the placebo arm and hence 22 patients were analysed.||Unitless||Standard Deviation|Mean
139508|NCT00473876|Primary|Peak VO2|Peak VO2 after 4 months of intervention with either metformin or placebo. The Mean difference between baseline and after 4 months was analyzed using t-test comparing metformin and placebo.|4 months|.In the metformin group,3 patients were lost to follow up therefore excluded from analysis.5 patients were discontinued on medications due to side effects, however,were included in our intention to treat analysis.In the placebo group,1 patient was lost to follow up and was excluded from analysis||ml/kg/min||Standard Deviation|Mean
139509|NCT00473837|Secondary|Curve of Hb Change Between Day 3 and Day 30 in the Two Placebo Arms; Changes in Markers of Iron Status, Measures of Inflammation, and Hb Response Between Day 3 and Day 30, and Between Day 3 and Day 90||90 days||||||
139510|NCT00473837|Primary|Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms||90 days|||g/L||Standard Deviation|Mean
139511|NCT00473824|Primary|Proportion of Subjects Who Achieve Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)) Post-transplant by ≥ 2 log10 From the Baseline Pre-transplant Value.|Baseline is the pre-transplant HCV viral load as measeured by RT-PCR. Post-transplant HCV viral load is determined at both 1 month and 6 months post-tranplant.|Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.|As the study was terminated early and since no participant in either arm achieved reduction in viral load, it was recorded that zero particpants and zero percent in each arm achieved reduction in viral load.||percentage of participants|||Number
139512|NCT00473746|Secondary|Phase 2: Duration of Objective Response|Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic duration of objective response.||days||95% Confidence Interval|Median
139513|NCT00473746|Secondary|Phase 2: Overall Survival|Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause.|Up to Month 60|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
139514|NCT00473746|Secondary|Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score|ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3=capable of limited self-care, confined to bed or chair >50% of waking hours. 4=completely disabled, not capable of any self-care, totally confined to bed or chair. 5=dead.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||participants|||Number
139515|NCT00473746|Secondary|Phase 2: Duration of PSA Response|Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
139516|NCT00473746|Secondary|Phase 2: Time to PSA Progression|The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
139517|NCT00473746|Secondary|Phase 2: Radiographic Objective Response Rate (RAD-ORR)|The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|Thirteen evaluable participants with measurable disease at baseline were evaluated for radiographic objective response rate.||participants|||Number
139518|NCT00473746|Secondary|Phase 2: PSA Progression Free Survival (PSA-PFS)|PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study.||days||95% Confidence Interval|Median
139519|NCT00473746|Secondary|Phase 2: Radiographic Progression Free Survival (RAD-PFS)|RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 weeks from start of treatment|ITT population included all participants who were enrolled into the study. RAD-PFS was not analyzed because of insufficient data to provide a meaningful estimate of the median and associated confidence interval (CI)||days||Full Range|Median
139550|NCT00473512|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Abiraterone|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hour||Standard Deviation|Mean
139520|NCT00473746|Secondary|Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||Liter (L)||Standard Deviation|Mean
139521|NCT00473746|Secondary|Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||liter per hour (l/hr)||Standard Deviation|Mean
139522|NCT00473746|Secondary|Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hour (hr)||Standard Deviation|Mean
139523|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hr*nmol/L||Standard Deviation|Mean
139524|NCT00473746|Secondary|Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hr*nmol/L||Standard Deviation|Mean
139525|NCT00473746|Secondary|Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose)|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3|ITT population included all participants who were enrolled into the study.||hour (hr)||Standard Deviation|Mean
139526|NCT00473746|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate|Blood samples for pharmacokinetic (PK) measurements was taken on Day –7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day –6 at 24 hour (postdose) and Day –5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose).|At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.|ITT population included all participants who were enrolled into the study.||nanomoles per liter (nmol/L)||Standard Deviation|Mean
139527|NCT00473746|Primary|Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)|Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement.|Up to 12 weeks from start of treatment|Intent-to-treat (ITT) population included all participants who were enrolled into the study.||participants|||Number
139528|NCT00473746|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate|The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects.|Up to Cycle 12|Safety population included all enrolled participants who received any study drug. MTD of abiraterone acetate was not reached because the doses administered appear to be well tolerated with no Dose Limiting Toxicity (DLT) even at 1000 milligram per day (mg/day [recommended maximum dose for phase 1]) and 1000 mg/day was taken as test dose in phase 2.||mg/day|||Number
139529|NCT00473655|Secondary|ApoB Levels|Change in the levels from baseline to end of study|8 weeks|||mg/dl||Standard Deviation|Mean
139530|NCT00473655|Secondary|Adverse Events Reported|Number of participants with AEs and SAEs reported|8 weeks|||Participants|||Number
139531|NCT00473655|Secondary|hsCRP Reduction|Reduction from baseline to end of study|8 weeks|||mg/L||Standard Deviation|Mean
139532|NCT00473655|Secondary|ApoA1 Levels|Change in the levels from baseline to end of study|8 weeks|||mg/dl||Standard Deviation|Mean
139533|NCT00473655|Secondary|HDL-C Increase|Increase from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
139534|NCT00473655|Secondary|Total Cholesterol Reduction|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
139535|NCT00473655|Secondary|LDL-C Reduction|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
139536|NCT00473655|Secondary|Non-HDL-C Reduction|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
139537|NCT00473655|Primary|Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)|Reduction from baseline to end of study|8 weeks|||mg/dL||Standard Deviation|Mean
141865|NCT00454181|Secondary|Subject Questionnaire Regarding Changes in Warts|"Number of subjects reporting change in oral warts from baseline to week 24 as better. Scale was subjective with 3 choices: better, worse, or unchanged."|24 weeks, from baseline to the end of treatment|||participants|||Number
139538|NCT00473642|Primary|Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol|Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study, the number of letters gained over the course of the study. In other words the baseline visual acuity in letters was subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.|12 months|||letters||Standard Deviation|Mean
139539|NCT00473642|Secondary|Time to First Retreatment After Loading Doses, Average Number of Retreatments Over 12 Months, Central Macular Thickness on OCT, the Number of Recurrent CNV, the Number of Patients With Persistent CNV After the Mandatory Loading Doses.||12 months||||||
139540|NCT00473642|Primary|Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months||12 months||||||
139541|NCT00473590|Secondary|Number of Participants With Selected Adverse Events (AEs)|Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All serious adverse events are listed in the Adverse Event Reporting section.|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).|Safety population: all patients who were randomized and received any amount of study treatment. Two patients who randomized to the BORT + P arm received at least 1 dose of bevacizumab and were analyzed as bevacizumab-treated patients. Therefore, the safety analysis included 50 patients in the BORT + P arm and 50 patients in the BORT + BV arm.||Participants|||Number
139542|NCT00473590|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time from randomization to disease progression or death on study from any cause within 30 days of the last response assessment. Disease progression was determined by the investigator using the International Myeloma Working Group's (IMWG) uniform response criteria. Median PFS was estimated using Kaplan-Meier methodology. For patients who were alive at the time of the analysis and whose disease had not yet progressed, PFS was censored at the time of the last response assessment.|From randomization to disease progression or death on study (up to 116 weeks).|Randomized Patients||months||95% Confidence Interval|Median
139543|NCT00473590|Secondary|Overall Survival (OS)|Overall survival was defined as the duration of time from randomization until death from any cause. All deaths were included, whether they occurred on study treatment or following treatment discontinuation. Overall survival was estimated using Kaplan-Meier. For patients who had not died, overall survival was censored at the date that the patient was last known to be alive.|From randomization until death from any cause, up until the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients||Months||95% Confidence Interval|Median
139544|NCT00473590|Secondary|Duration of Response|Duration of response was defined as the time from the initial response to disease progression or death on study. Disease progression was determined by the investigator using the IMWG’s uniform response criteria and defined as an increase of ≥25% from best response in: Serum M-protein and/or Urine M-protein and/or Marrow plasma cells; or new or increased plasmacytomas or bone lesions; or hypercalcemia due to myeloma. Duration of response was estimated using Kaplan-Meier. For patients who had not progressed or died, duration of response was censored at the date of the last response assessment.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients with an overall response||Months||95% Confidence Interval|Median
139545|NCT00473590|Secondary|Percentage of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the IMWG's uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients||Percentage of Participants||95% Confidence Interval|Number
139546|NCT00473590|Secondary|Number of Participants With an Overall Response|Overall response was defined as a stringent complete response, complete response, very good partial response, or partial response (sCR, CR, VGPR, and PR, respectively) determined on two consecutive assessments ≤ 6 weeks apart and before the initiation of any new anti-tumor therapy, as assessed by the investigator using the International Myeloma Working Group’s (IMWG's) uniform response criteria. Patients without a post-baseline response assessment or who died prior to their first scheduled response assessment were considered non-responders.|From randomization to the end of study (clinical cut-off; up to 116 weeks).|Randomized Patients||participants|||Number
139547|NCT00473564|Secondary|Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.|Assessment of patient safety evaluating the number of participants who experienced known complications from the use of the da Vinci® Robotic System during surgery, who experienced a need for conversion to open surgery during the procedure, or who required additional surgery for re-excision of the lesion due to positive margins|3 - 24 months postoperatively|Participants who successfully underwent transoral robotic-assisted surgery using the da Vinci® Robotic System||participants|||Number
139548|NCT00473564|Primary|Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions|Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions|Intraoperatively average of 2 hours|||participants|||Number
139549|NCT00473512|Other Pre-specified|Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone|The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.|||||
139934|NCT00468819|Secondary|Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group|In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality).|Up to 1 hour after Gadobutrol injection|FAS||Participants|||Number
139551|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours*nmol/L||Standard Deviation|Mean
139552|NCT00473512|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone|Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours*nmol/L||Standard Deviation|Mean
139553|NCT00473512|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||hours||Standard Deviation|Mean
139554|NCT00473512|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The Cmax is defined as maximum observed analyte concentration.|Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||nmol/L||Standard Deviation|Mean
139555|NCT00473512|Other Pre-specified|Mean Plasma Concentration of Abiraterone||Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given|Data was not statistically summarized but reported in individual participant listing as per planned analysis.|||||
139556|NCT00473512|Other Pre-specified|Number of Participants With Change From Baseline in Biochemical Bone Markers||Baseline, Cycle 2, 4, 8, 12|Data was reported in individual participant listings but not summarized due to statistical constraints.|||||
139557|NCT00473512|Other Pre-specified|Time to Prostate Cancer Pain Progression|The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method.|Baseline up to 12 cycles|Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.|||||
139558|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone Precursors|Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.||ng/dL||Full Range|Median
139559|NCT00473512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after the last dose of study medication|Included all participants who received any amount of the study medication.||participants|||Number
139560|NCT00473512|Other Pre-specified|Serum Blood Levels of Testosterone|Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).|Baseline, Cycle 2 (within 3 days prior to Day 29)|All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point.||ng/dL||Full Range|Median
139561|NCT00473512|Secondary|Overall Survival|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|Baseline up to end of study (1160 days)|Data was not analyzed due to high number of participants censored for survival.|||||
139562|NCT00473512|Secondary|Time to Disease Progression|Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.|Baseline up to end of study (1160 days)|Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression.|||||
139598|NCT00473330|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
139563|NCT00473512|Secondary|Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up.|||||
139564|NCT00473512|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Days||Full Range|Median
139565|NCT00473512|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|Baseline up to end of study (1160 days)|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
139566|NCT00473512|Primary|Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12|The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response.|Baseline, Week 12|All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Participants|||Number
139567|NCT00473434|Secondary|The Length of Hospitalizations Throughout the Study||52 weeks|Participants who were hospitalized and had evaluable data at each measurement time point||days||Standard Deviation|Mean
139568|NCT00473434|Secondary|The Number of Hospitalizations Throughout the Study|This outcome measure is intended to document all hospitalizations that occurred throughout the study.|52 Weeks|All participants with evaluable data at each measurement time point||events|||Number
139569|NCT00473434|Secondary|The Percentage of Participants Presenting Clinical Deterioration Throughout the Study|This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.|52 Weeks|All participants with evaluable data at each measurement time point||percentage of participants|||Number
139570|NCT00473434|Secondary|The Global Assessment of Functioning (GAF) Throughout the Study|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|52 Weeks|All participants with evaluable data at each measurement time point||scores on a scale||Standard Deviation|Mean
139571|NCT00473434|Secondary|The Clinical Global Impression of Severity (CGI-S) Throughout the Study|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|52 weeks|All participants with evaluable data at each measurement time point||scores on a scale||Standard Deviation|Mean
139572|NCT00473434|Primary|The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population||mg||95% Confidence Interval|Median
139573|NCT00473434|Primary|The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12||Week 0 to Week 12|Intent-To-Treat (ITT) population||mg||Standard Deviation|Mean
139574|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57||mg||95% Confidence Interval|Median
139575|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84||Day 57 to Day 84|Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57||mg||Standard Deviation|Mean
139576|NCT00473434|Primary|The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population||mg||95% Confidence Interval|Median
139577|NCT00473434|Primary|The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84||Day 1 to Day 84|Intent-To-Treat (ITT) population||mg||Standard Deviation|Mean
139578|NCT00473382|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
143639|NCT00439335|Secondary|HAI Geometric Mean Titer (GMT) After Dose 2|HAI geometric mean titer (GMT) against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine.|Approximately Day 56.|||Antibody Titer||95% Confidence Interval|Geometric Mean
139579|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
139580|NCT00473382|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
139581|NCT00473382|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
139582|NCT00473382|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Treatments||Standard Deviation|Mean
139583|NCT00473382|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
139584|NCT00473382|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
139585|NCT00473382|Secondary|Mean Change From Baseline in Central Foveal Thickness at Months 24, 36, and 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
139586|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Letters||Standard Deviation|Mean
139587|NCT00473382|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
139635|NCT00470392|Secondary|Number of Subjects With a 1.5 Fold Increase in mRNA Expression of GRAMD1A and DMXL2|Based upon upregulated mRNA expression of MyxA in 1 out of 7 patients treated with Imiquimod, a list of alternative target genes responsive to Imiquimod was generated. The target mRNAs examined included GRAMD1A, IL2RA, TGHD1, DMXL2. The target gene was consider upregulated if there was a 1.5 fold increase in the mRNA expression of the target gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment|||participants|||Number
139588|NCT00473382|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
139589|NCT00473382|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
139590|NCT00473382|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.||Percentage of patients||95% Confidence Interval|Number
139591|NCT00473330|Secondary|Mean Change From Month 36 in Central Foveal Thickness in the Study Eye at Month 48|Central foveal thickness was assessed in optical coherence tomographic images by the central reading center. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||µm||Standard Deviation|Mean
139592|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score in the Study Eye From Month 36 at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of participants||95% Confidence Interval|Number
139593|NCT00473330|Secondary|Mean Change From Month 36 in Best Corrected Visual Acuity (BCVA) Score in the Study Eye at Month 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 36 to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. The Month 48 data are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
139594|NCT00473330|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 36 and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
139595|NCT00473330|Secondary|Mean Number of Macular Laser Treatments From Baseline Through Months 24 and 36|The need for macular laser treatment was evaluated by the masked (evaluating) physician. Macular laser was administered per protocol-specified objective and subjective criteria starting at Month 3.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Treatments||Standard Deviation|Mean
139596|NCT00473330|Secondary|Percentage of Patients With Resolution of Leakage at Month 24|Resolution of leakage was defined as total area of fluorescein leakage in the central, inner, and outer subfields of the 0 Disc Area. Leakage was assessed in fluorescein angiographic images by the central reading center.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
139597|NCT00473330|Secondary|Percentage of Patients With a ≥ 3-step Worsening From Baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale Score for Eyes at Months 24 and 36|The severity of diabetic retinopathy was graded on a 10-point scale by the central reading center by comparing patient fundus photographic images with a set of standard images. 1=diabetic retinopathy (DR) severity level 10, 12 (DR absent), 2=DR severity level 14A-14C, 14Z, 15, 20 (DR questionable, microaneurysms only), 3=DR severity level 35A-35F (mild non-proliferative [NP]DR), 4=DR severity level 43A, 43B (moderate NPDR), 5=DR severity level 47A-47D (moderately severe NPDR), 6=DR severity level 53A-53E (severe NPDR), 7=DR severity level 60, 61A, 61B (mild proliferative [P]DR), 8=DR severity level 65A-65C (moderate PDR), 9=DR severity level 71A-71D (high-risk PDR), 10=DR severity level 90 (cannot grade). A lower score indicates less severe diabetic retinopathy.|Baseline to Month 36|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Percentage of patients||95% Confidence Interval|Number
139599|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24 and 36 in Patients With Focal Edema at Baseline|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 36|Subgroup of the intent-to-treat population: All randomized patients with focal edema at baseline, whether or not treatment was received. Missing data were imputed using the last observation carried forward method.||Letters||Standard Deviation|Mean
139600|NCT00473330|Secondary|Percentage of Patients Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
139601|NCT00473330|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Months 24, 36, and 48|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Months 24, 36, and 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Percentage of patients||95% Confidence Interval|Number
139602|NCT00473330|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Months 24, 36, and 48|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Baseline to Month 48|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed up to Month 36 using the last observation carried forward method. The Month 48 outcome measures are based on the observed data for patients enrolled in the open-label extension phase; missing data were not imputed.||Letters||Standard Deviation|Mean
139603|NCT00473330|Primary|Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 24|Intent-to-treat population: All randomized patients, whether or not treatment was received. Missing data were imputed using the last observation carried forward.||Percentage of patients||95% Confidence Interval|Number
139604|NCT00473265|Secondary|Mineralizing Surface|Mineralizing surface done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Mineralizing surface measures how much of bone is getting new mineral put on it. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus one year|Only 14 subjects had paird bone biopsies obtained at baseline and after 12 months of PTH(1-84) treatment.||percentage of surface||Standard Deviation|Mean
139605|NCT00473265|Secondary|Cortical Porosity|Cortical porosity done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Cortical Porosity measures how many tiny holes there are in the solid bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.||percentage of porosity||Standard Deviation|Mean
139606|NCT00473265|Secondary|Trabecular Number|trabecular number done on histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular number is the number of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.||mm^-1||Standard Deviation|Mean
139607|NCT00473265|Secondary|Trabecular Width|Trabecular width was obtained from histomorphometric assessment of percutaneous iliac crest bone biopsy. Trabecular width is the thickness of individual pieces of the spongy bone section. The structure and microscopic organization of a small piece of biopsied pelvic bone was analyzed.|baseline versus two years|Only 16 subjects had paired bone biopsies obtained at baseline and after 24 months of PTH(1-84) treatment.||micrometers||Standard Deviation|Mean
139608|NCT00473265|Secondary|Percent Change in BMD From Baseline to 24 Months by DXA|Bone Mineral Density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA).|baseline versus 24 months|Only the first 30 participants who completed 24 months of the study were analyzed||percentage of change to BMD||Standard Deviation|Mean
139609|NCT00473265|Primary|Requirements for Calcium Supplementation|Serum and urinary calcium levels maintained by change in requirements for calcium supplementation|2 years|Only the first 30 participants to complete 24 months in the study were analyzed||grams per day of calcium supplementation||Standard Deviation|Mean
139636|NCT00470392|Secondary|Number of Subjects With Improvement in Lesional Psoriasis Area and Assessment (PASI) Score After Imiquimod and UVB Treatment|The PASI is a disease burden measure that integrates area, erythema, thickness and scale of each target lesion. The severity score for each region is calculated by adding the scores for redness, thickness and scale (each of which are graded from 0 to 4). The maximum severity score is 12. The higher the PASI, the worse the disease. Thus, an improvement in PASI score is a lower score than the pre-treatment PASI.|2 weeks after Imiquimod and UVB|Per protocol.||participants|||Number
140412|NCT00465972|Primary|Response: Change in Insomnia Severity Rating Scale at 3 Months.|Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.|Baseline and 3 months|This is the LOCF population||units on a scale||Standard Deviation|Mean
139610|NCT00472849|Primary|Maximum Total Tolerated Dose (MTD) of Daily Combination Fludarabine 30 mg/m^2 and Cytarabine 500 mg/m^2 Among 3 Dose Levels (Dose Level 1: 2 Days, Dose Level 2: 3 Days or Dose Level 3: 4 Days)|Maximum dose levels for Phase I determined among three possible dose levels of Fludarabine and Cytarabine in combination with fixed doses of Oxaliplatin and Rituximab. Fludarabine and Cytarabine Dose Level 1: Days 2-3 (2 Days); Dose Level 2: Days 2-4 (3 Days); and Dose 3: Days 2-5 (4 Days). MTD is dose level at which less than 2/3 or 2/6 participants experience dose limiting toxicities (DLTs). The number of days of fludarabine and cytarabine administration increased simultaneously. Participants received a subsequent cycle of treatment with 1 additional day of fludarabine and cytarabine treatment no less than 4 weeks from the initiation of the previous cycle if no drug-related grade 3 or 4 non-hematologic life-threatening adverse events, and drug-related non-hematologic toxicity resolved to baseline or < grade 2. A maximum of 6 cycles were administered.|Up to 36 weeks (6 cycles each 4-6 weeks)|||mg/m^2|||Number
139611|NCT00472849|Secondary|Overall Response: Number of Participants With Complete Remission, Nodular Partial Remission, and Partial Remission|Overall Response includes Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) in high-risk, previously untreated participants with Chronic Lymphocytic Leukemia treated with CFAR using National Cancer Institute - Working Group response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy.|Up to 36 weeks (6 cycles each 4-6 weeks)|||participants|||Number
139612|NCT00472797|Other Pre-specified|SF-36 Physical and Mental Component Scores|Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.|Change from Baseline to Each Visit|ITT||Score||Standard Deviation|Mean
139613|NCT00472797|Secondary|Tolerability - Redness at Injection Site|Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.|Baseline to Week 12 (LOCF)|ITT and LOCF||mm||Standard Deviation|Mean
139614|NCT00472797|Secondary|Tolerability in Pain Using Visual Analog Scale (VAS)|The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.|Baseline to Week 12|ITT||Participants|||Number
139615|NCT00472797|Secondary|Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12|The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).|Baseline to Week 12|ITT and LOCF||score on scale||Standard Deviation|Mean
139616|NCT00472797|Secondary|Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 – score at baseline.|Baseline to Week 12|||score on scale||Standard Deviation|Mean
139617|NCT00472797|Secondary|Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).|Baseline and Week 12|Intent to Treat (ITT) and Last Observation Carried Forward (LOCF) Higher scores indicate a more favorable response||score on scale||Standard Deviation|Mean
139618|NCT00472797|Primary|Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)|The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 – score at baseline) / score at baseline.|% change from Baseline to Week 12|Safety: This population includes all subjects who received at least one dose of study drug. To explain difference in number, 1 subject lost to follow-up, 1 subject withdrew consent||percent change||Standard Deviation|Mean
139619|NCT00472732|Primary|Fractional Anisotropy|Measure of white matter integrity in OTCD Patients and Controls in frontal white matter. Fractional anisotropy values fall on a scale of 0 to 1, with 0 meaning that the diffusion of water is isotropic and unrestricted, or equally restricted, in all directions and with 1 meaning that diffusion occurs along only one axis and is fully restricted along all other directions. Scores closer to 1 are associated with intact white matter while scores closer to 0 are associated with white matter damage.|one time measurement at study baseline|Five OTCD Patients and four healthy controls were excluded due to excessive head motion.||units on a scale||Standard Deviation|Mean
139620|NCT00472732|Primary|Functional MRI Activation in N-Back Tast|"Measure of blood oxygen level dependent (BOLD) signal of OTCD patients and healthy controls during an N-Back task comparing 2-back and 1-back conditions. This contrast was created for each participant using SPM and then entered into a group analysis in which we compare percent signal change between groups. Therefore, we never see BOLD signal change at the individual level, which is why we never see scores or numbers at the individual level and we cannot calculate a measure of dispersion for this data."|one time measurement at study baseline|Five OTCD patients and one healthy control were excluded due to excessive head motion.||percent signal change|||Number
139637|NCT00470392|Primary|Number of Subjects With Elevated MyxA|Lesions were treated with either Imiquimod or Clobetasol cream. Lesions were subsequently treated with UVB and biopsied. From the biopsy samples obtained from the Imiquimod arm, quantitative PCR was performed to measure levels of Myx A, an imiquimod response gene.|Biopsy samples for analysis were taken 1 hour post UVB treatment|Per protocol.||participants|||Number
139638|NCT00470301|Primary|Pathologic Complete Response Rate (pCR) Evaluated Using RECIST (Phase II)|An increase in the breast pCR from 15% (anticipated for chemotherapy alone) to 35% would be considered promising.|Up to 5 years|||participants||95% Confidence Interval|Number
139621|NCT00472732|Primary|Concentration of Glutamine and Myoinositol by MRS|"Concentration based on area under curve on 1H MRS and quantitated by LCModel. A metabolite’s tissue concentration is related to the integrated amplitude of the MRS signal it produces. Integrated amplitude is the area under the MRS signal curve. While MRS signals are usually acquired in the time domain as free induction decays or echoes, they are usually viewed and analyzed in the frequency domain. The frequency domain representation is derived from the acquired time domain data by the Fourier Transform. The protocol we use selects 257 averages. This means, 257 free induction decays. The machine summates the data at each time point to generate one value for the area under the curve. Therefore, we don’t have the measurement at each time point.~Furthermore, we measured voxels in two different brain areas containing different kinds of brain matter: one voxel was located in posterior cingulate gray matter (PCGM) and the other in parietal white matter (PWM)."|one time measurement at study baseline|||mM||Standard Deviation|Mean
139622|NCT00472576|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is the primary outcome.|Measured daily for 12 days, where the endpoint is the primary outcome|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.||Score on a scale||Standard Error|Least Squares Mean
139623|NCT00472576|Secondary|Hamilton Depression Rating Scale (HDRS)|The Hamilton Depression Rating Scale (HDRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 17 item version range from 0 to 52. Generally, a score of 18 or greater is used to indicate a substantial depression level. The measure at the end of the study is primary.|Measured daily for 12 days, where the endpoint is primary|The number of participants includes all patients who received at least one rating after taking even a single dose of either active drug or placebo.||Score on a scale||Standard Error|Least Squares Mean
139624|NCT00472446|Secondary|Hospital Stay|time from surgery to Hospital release in days|90 days|||days||Standard Deviation|Mean
139625|NCT00472446|Secondary|Mean Consumption of Post-operative Analgetics|mean pooled dose of post-operative analgetics|5 days after surgery|||gram||Standard Deviation|Mean
139626|NCT00472446|Secondary|Consumption of Post-operative Analgetics|number of participants taking post-operative analgetics|5 days after surgery|||participants|||Number
139627|NCT00472446|Secondary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|24 hours after surgery|||units on a scale||Standard Deviation|Mean
139628|NCT00472446|Primary|Pooled Relative Treatment Effect of VAS|"Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain)~The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1)"|4 days after surgery|||pooled relative treatment effect||95% Confidence Interval|Number
139629|NCT00472446|Primary|Post-operative Pain Measured by Visual Analogue Scale|Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)|6 hours after surgery|||units on a scale||Standard Deviation|Mean
139630|NCT00472420|Secondary|Event Free Survival (EFS)|EFS was defined as the median time, in months, from the date of study entry disease progression, relapse, secondary malignancy, death or last contact. Relapse was defined by: a) appearance of any new lesion or a ≥ 50% increase in size of previously involved sites, or b) ≥ 50% increase in GTD of any previously identified LN >1 cm in short axis or in the SPD of more than one LN. The 95% CI was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population||months||95% Confidence Interval|Median
139631|NCT00472420|Secondary|Progression Free Survival (PFS)|PFS was defined as the median time, in months, from the date of study entry to disease progression, death due to mantle cell lymphoma, or last contact. Progressive disease (PD) was defined by: a) 50% increase from nadir in the SPD of any previously identified abnormal LN, or b) appearance of any new lesion during or at the end of treatment. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.|Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population||months||95% Confidence Interval|Median
139632|NCT00472420|Primary|Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)|CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) > 75% decrease in SPD of LNs > 1.5 cm, and > 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.|Screening, Baseline (BL), every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)|ITT population||participants|||Number
139633|NCT00470418|Secondary|Changes From Baseline in Clinical Measures of Cognition at Terminal Visit|Mini-Mental Status Exam (MMSE) 0(worst)-30(best); ADAS-cog 0 (best cognitive performance across multiple domains) - 70(worst); Activities of Daily Living (ADCS-ADL) 0(least capable of function in daily and instrumental activities)-54(best)|baseline and six weeks|||units on a scale||Standard Deviation|Mean
139634|NCT00470418|Primary|Safety Assessments: Number of Participants With Adverse Events|vital signs, physical exam, Symptom Checklist, complete blood count, serum chemistries, urinalysis, and electrocardiogram|Safety Labs, Physical Exams: 6 times over 7 weeks. Adverse Events assessed 21 times over the course of 7 weeks|||Participants|||Count of Participants
139640|NCT00470275|Primary|Response|Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|the first six cycles of study chemotherapy (126 days)|||participants|||Number
139641|NCT00470262|Secondary|IMCL|Intramyocellular lipid was measured using immunohistochemistry (using oil Red O staining) in muscle biopsy specimens. Oil red O-stained muscle sections were magnified with an Olympus Provis (Tokyo, Japan) light microscope, and images were digitally captured by using a connected charge-coupled device camera (Sony, Tokyo, Japan). Fiber-typed and oil red O-stained fibers were matched. The oil red O staining intensity of either type 1 or 2 muscle fibers was quantified using National Institutes of Health Image program (http://rsb.info.nih.gov/nih-image/). By adjusting a density threshold, the software was set to recognize the presence of one fat droplet only if its highlighted surface was exceeding 0.40 μm2 or larger. Muscle lipid content was calculated by total area of lipid droplets in a given muscle fiber divided by the total area of the same fiber. The mean number of fibers analyzed per sample was 40 for type 1 and 2 muscle fibers|3 months|||% of lipid area stained||Standard Deviation|Mean
139642|NCT00470262|Primary|Insulin Sensitivity|Insulin sensitivity was measure through frequently sampled intravenous glucose tolerance test. Subjects presented to research center fasting. Blood samples were collected at -21, -11, and -1 minutes. At time t=0 initiates the start of the IVGTT and the injection of glucose into the non-sampling arm. The glucose dose was calculated as 11.4g/m2 of body surface area, given as a 50% dextrose solution. This glucose injection was administered over 60 seconds or less. At time t=20 minutes, an insulin dose of 0.04u/kg was administered over 30 seconds. Blood samples were collected at times t=2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140, 160, and 180. If blood sugar did not return to a steady state the test was continued to t= 210 or t= 240.|3 months|||mg*kg^-1*min^-1||Standard Deviation|Mean
139643|NCT00470184|Secondary|Quality of Life Improved Rate||5.5 weeks|evaluable patients||percentage of patients||95% Confidence Interval|Number
139644|NCT00470184|Secondary|Median Time to Progression||5.5 weeks|Evaluable patients||months||95% Confidence Interval|Number
139645|NCT00470184|Secondary|Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1||5.5 weeks|evaluable patients||percentage of patients||95% Confidence Interval|Number
139646|NCT00470184|Primary|Complete Response||5.5 weeks|Evaluable Patients||percentage of patients||95% Confidence Interval|Number
139647|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the maintenance phase. A negative mean change indicates an improvement."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Safety Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.||units on a scale||Standard Deviation|Mean
139648|NCT00472303|Secondary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the titration phase."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Per Protocol Set (Titration Phase), observed. Start of Titration and Endpoint Titration observations.||units on a scale||Standard Deviation|Mean
139649|NCT00472303|Secondary|Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.~The following withdrawal categories are based on the total COWS score:~None: total score below 5;~Mild: total score from 5 to 12;~Moderate: total score 13 to 24;~Moderately Severe: total score 25 to 36;~Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 43 (End of Maintenance Phase)|Safety Analysis Set. Participants that did not discontinue due to adverse event during the first week of the maintenance phase and started opioid after last study medication.||participants|||Number
139668|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.||units on a scale||Standard Deviation|Mean
139650|NCT00472303|Secondary|Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.|"This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.~The following withdrawal categories are based on the total COWS score:~None: total score below 5;~Mild: total score from 5 to 12;~Moderate: total score 13 to 24;~Moderately Severe: total score 25 to 36;~Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication."|Day 14 (End of Titration Phase)|Safety Analysis Set (Titration Phase). Participants that took at least one dose of trial medication in the titration phase, and discontinued trial medication at the end or during the titration phase and did not continue on other opioid medication.||participants|||Number
139651|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of maintenance to the completion of treatment is reported. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|"FAS (Maintenance Phase) Last Observation Carried Forward for participants re-randomized.~Tapentadol: 105 participants responded at the start and 103 participants at the end.~Morphine: 108 participants responded at the start and 107 participants at the end.~Placebo: 110 participants responded at the start and 107 participants at the end."||participants|||Number
139652|NCT00472303|Secondary|Quality of Sleep (Sleep Questionnaire) in the Titration Phase.|"Participants were asked the following question: Please rate the overall quality of your sleep last night? The quality of sleep from the start of the titration phase to the end of the titration phase was measured. The participant could choose one of the following options: Excellent, good, fair and poor."|Day 1 (Start of Titration); Day 14 (end of Titration Phase)|"Full Analysis Set (Titration Phase), observed. Tapentadol: 302 participants dosed gave a response at the start of titration and from 309 participants at the end of titration.~Morphine: 143 participants dosed gave a response at the start of titration and from 142 participants at the end of titration."||participants|||Number
139653|NCT00472303|Secondary|Patient Global Impression of Change|"In the Patient Global Impression of Change (PGIC) the participant is asked Since I began study treatment, my overall status is. The participant is asked to circle one of seven categories. Scores range from very much improved to very much worse. The question was asked at the end of the maintenance phase with reference to the start of the maintenance phase where the participant continued at the dose that was effective at the end of the Titration Phase."|Day 43 (End of Maintenance Phase)|Full Analysis Set, observed.||participants|||Number
139654|NCT00472303|Secondary|Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from Day 15, a negative mean value indicates a worsening of health-related quality of life since the start of the maintenance phase.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.||units on a scale||Standard Deviation|Mean
139655|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).~The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A negative change in the mean indicates a worsening in health status since the beginning of the maintenance phase. A positive change indicates an improvement in health. The minimal important difference in the Health Status Index is 0.074 (range -0.011 to 0.140)."|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations. No morphine treatment analysis was planned.||units on a scale||Standard Deviation|Mean
139656|NCT00472303|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate better health. The values indicated represent the change from Day 1, a positive value indicates an improvement since the start of treatment.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.||units on a scale||Standard Deviation|Mean
139657|NCT00472303|Secondary|Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.|"The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).~The responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A positive change in the mean indicates that during this phase the health status improved. A positive change indicates an improvement in health. The minimal important difference is 0.074 (range -0.011 to 0.140)."|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Phase), observed.||units on a scale||Standard Deviation|Mean
139725|NCT00471718|Secondary|Overall Survival|Number of weeks from the date the patient started study drug to the date of the patient's death.|date on study to date of death from any cause|At the time of this analysis, all 27 patients were deceased due to progressive prostate cancer.||Weeks||95% Confidence Interval|Median
139658|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)|Full analysis set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.||units on a scale||Standard Deviation|Mean
139659|NCT00472303|Secondary|Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.|The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.|Day 1 (Start of Titration); Day 14 (End of Titration Phase)|Full analysis set (Titration Period), observed. Start of Titration and Endpoint Titration observations.||units on a scale||Standard Deviation|Mean
139660|NCT00472303|Secondary|The Average Mean Total Daily Dose of Rescue Medication.|Mean total daily dose of rescue medication morphine sulphate immediate release tablets in milligrams per day (mg/day).|Day 1 (Start of Titration Phase) through Day 43 (End of Maintenance Phase)|Full analysis set for each phase of the trial, observed.||milligrams per day of morphine rescue||Standard Deviation|Mean
139661|NCT00472303|Secondary|Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase|Participants were issued morphine 10 mg immediate release medication. The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the maintenance phase were counted. This use of morphine immediate release was captured in each participant's electronic diary.|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance phase), observed.||participants|||Number
139662|NCT00472303|Secondary|Use of Rescue Medication in the Titration Phase.|"The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the titration phase were counted. This data was captured in an electronic diary.~During the trial, morphine immediate release 10 mg was allowed as required without a maximum dose defined. However, participants were only re-randomized if their mean consumption of rescue medication was less or equal to 2 doses (20 mg) per day during the last 3 days of the titration phase)."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration phase), observed.||participants|||Number
139663|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the 3 days prior to re-randomization or during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 15 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.||units on a scale||Standard Deviation|Mean
139664|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Observed, i.e. participants contributing data via their electronic diary.||units on a scale||Standard Deviation|Mean
139665|NCT00472303|Secondary|Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.|"Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Phase), observed.||units on a scale||Standard Deviation|Mean
139666|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Period). Last observation carried forward.||units on a scale||Standard Deviation|Mean
139667|NCT00472303|Secondary|Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.|"Participants were asked to record their average pain over the last 24 hours pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Day 1 through Day 14 (End of Titration Phase)|Full Analysis Set (Titration Period), observed.||units on a scale||Standard Deviation|Mean
139726|NCT00471718|Secondary|Median Time to Tumor Progression|"Number of weeks from the date the patient started study drug to the date of the patient's tumor progression documented radiographically or by PSA testing.~Tumor progression is measured at baseline and after two 28-day cycles"|date on study to date of progression|Patients who received treatment and who were available for measurement of tumor or who available for PSA testing||Weeks||95% Confidence Interval|Median
139669|NCT00472303|Primary|Number of Participants Scored as Responder in Maintenance Phase.|"A responder is a participant in the study that:~completed 28 days of the maintenance phase~had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.~did not use more than 20 mg of rescue medication per day on average in the 28 day maintenance period (from Day 18 to Day 43).~A participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that failed to meet only 1 of the 3 criteria is not counted as a responder."|Day 18 through Day 43 (End of Maintenance Phase)|Full Analysis Set (Maintenance Phase).||participants|||Number
139670|NCT00472290|Primary|Incidence of Antibody (AB) Formation||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks.|Safety analysis includes subjects who took at least one dose of romiplostim.||Participant|||Number
139671|NCT00472290|Secondary|Duration of Platelet Response|Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Weeks|Participants|Full Range|Median
139672|NCT00472290|Secondary|Time to First Platelet Response|Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Weeks|Participants|95% Confidence Interval|Median
139673|NCT00472290|Secondary|Weeks With Platelet Response Per Year|During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Weeks/Subject-year|Participants|95% Confidence Interval|Mean
139674|NCT00472290|Secondary|Platelet Transfusion Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Events/100 subject-year|Participants|95% Confidence Interval|Mean
139675|NCT00472290|Secondary|Weekly Bleeding Events Per 100 Subject Years|During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day.|During the treatment period. The average duration of romiplostim exposure is 56 weeks.|Safety analysis includes subjects who received at least one dose of romiplostim.||Events/100 subject-year|Participants|95% Confidence Interval|Mean
139676|NCT00472290|Primary|Overall Summary of Adverse Events||During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .|Safety analysis includes subjects who took at least one dose of romiplostim.||Participant|||Number
139677|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||bpm||Standard Deviation|Mean
139678|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Pulse Rate||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||bpm||Standard Deviation|Mean
139679|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
139680|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Diastolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
139681|NCT00472199|Secondary|Baseline, Week 26 Mean Standing Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
139682|NCT00472199|Secondary|Baseline, Week 26 Mean Supine Systolic Blood Pressure||Baseline, Week 26|Treated Set, all patients who were documented to have taken at least one dose of study medication||mm Hg||Standard Deviation|Mean
139683|NCT00472199|Secondary|Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation|"Worsening of RLS symptoms, in comparison to baseline, following abrupt treatment discontinuation (for patients with no added RLS therapy after study drug discontinuation).~Assessment of worsening of RLS was based on the IRLS total score assessed 7 ± 1 days after treatment discontinuation (the end of the study or premature discontinuation) compared with that at baseline. Analysis considered the number of patients experiencing a clinically relevant deterioration of ≥4 points in total IRLS score 7 ± 1 days after discontinuation of trial medication compared with baseline."|after at least 1 week of treatment discontinuation|Treated Set, all patients who were documented to have taken at least one dose of study medication||participants|||Number
139935|NCT00468819|Secondary|Urinary Excretion of Gadolinium as Percent of Administered Dose|Amount of gadolinium* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. *A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging.|up to 6 hours after Gadobutrol injection|Valid for urinary analysis||percentage of administered dose||Full Range|Mean
139684|NCT00472199|Secondary|Diagnosis of Classified Augmentation According to Independent Expert Panel|Augmentation is a worsening of RLS symptoms and may manifest as increased severity and the involvement of other extremities or as a shift of RLS symptoms to a time period that is 2 or more hours earlier than was typical of the time of symptom onset during the initial course of beneficial stable treatment or the state before recently starting treatment.|after at least 4 weeks of treatment|Treated Set and where patients received study medication for at least 4 weeks (Treated Set includes all patients who were documented to have taken at least one dose of of treatment)||participants|||Number
139685|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139686|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139687|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Vitality After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better vitality|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139688|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better social functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139689|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to physical problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139690|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less limitations due to emotional problems|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139691|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better physical functioning|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139692|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better mental health|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139693|NCT00472199|Secondary|Change From Baseline in SF-36 Dimension General Health After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating better health status|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139694|NCT00472199|Secondary|Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks|Score ranging from 0 to 100 with higher scores indicating less bodily pain|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139695|NCT00472199|Secondary|Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks|RLS QoL total score ranging from 0 to 100 with higher values indicating better quality of life|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139696|NCT00472199|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks|The scale measures pain on a continuous 100 mm axis ranging from no pain (0 mm) to unbearable pain (100 mm)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139697|NCT00472199|Secondary|Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks|Mood disturbance associated with RLS symptoms ranging from 0 (none) to 4 (very severe)|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||scores on a scale||Inter-Quartile Range|Median
139698|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Tired or Sleepy During the Day After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
143670|NCT00439218|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area under the plasma concentration versus time curve (AUC)|12 weeks|||µmol/L * hours||Standard Deviation|Mean
139699|NCT00472199|Secondary|"Change From Baseline RLS-6 Score Severity During the Day Engaged in Activities After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139700|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Day When at Rest After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139701|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity During the Night After 26 Weeks"|The question was rated on an 11-point Likert scale, ranging from “none/not at all” (0) to “very severe” (10), to reflect the patient’s condition during the previous week|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139702|NCT00472199|Secondary|"Change From Baseline in RLS-6 Score Severity Falling Asleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|Baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139703|NCT00472199|Secondary|"Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score Satisfaction With Sleep After 26 Weeks"|"The score is an 11-point Likert scale, ranging from “none/not at all” (0) to~“very severe” (10), to reflect the patient’s condition during the previous week"|baseline and 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Inter-Quartile Range|Median
139704|NCT00472199|Secondary|Patient Global Impression (PGI) Responder Rate|PGI scores ranging from '1' (very much better) to '7' (very much worse), PGI responder have scoring 1 or 2 (at least much better)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||participants|||Number
139705|NCT00472199|Secondary|International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate|IRLS response was defined as at least 50% reduction in IRLS total score from baseline. IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe symptoms)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||participants|||Number
139706|NCT00472199|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder Rate|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring 1 or 2 (at least much improved)|after 26 weeks of treatment|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values.||participants|||Number
139707|NCT00472199|Primary|Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks|IRLS total score ranging from 0 (no RLS symptoms) to 40 (very severe RLS symptoms)|Baseline and 26 weeks|Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values||Scores on a scale||Standard Error|Least Squares Mean
139708|NCT00472082|Secondary|Safety, Including Incidence of Post- Transplant Infections, Malignancies, Morbidities, Hypertension, Glucose Intolerance, Serum Cholesterol and Triglycerides Profile Over Time, Development of New Anti-donor Antibodies.||1 year||||||
139709|NCT00472082|Primary|Efficacy Will be Determined by Change in Renal Function as Measured by Cold Iothalamate Glomerular Filtration Rate(GFR)3 Months After Enrollment, and Acute Rejection Episodes Within the First 6 Months Post Enrollment.||6 months from conversion||||||
139710|NCT00472056|Primary|Disease-free Survival (DFS)|DFS defined as time from transplantation to disease relapse, disease progression, death during remission, or last follow-up. Evaluation at 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date.|Up to 5 years from transplant date.|Analysis was per protocol.||months||Full Range|Mean
139711|NCT00472030|Secondary|Change in Histamine Release Assay Following Treatment With Omalizumab.|The histamine release assay measures the release of histamine which occurs upon stimulation of basophilic granulocytes depending upon their sensitivity to an allergen.|Up to 24 weeks|We were unable to complete this assay in our research subjects due to technical difficulties.|||||
139712|NCT00472030|Secondary|Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16||Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||units per milliliter|||Number
139713|NCT00472030|Primary|Median Increase in Prednisone Dosage Measured at Week 4, 8 and 24 in Patients Treated With Omalizumab and in Patients Receiving Standard Therapy.|The total dose of prednisone required to control the bullous pemphigoid at week 4, 8 and 24 weeks was to be calculated in both arms of this study.|Week 4, Week 8 and Week 24|Neither subject required treatment with Prednisone. Since we did not enroll any subject in the Prednisone Standard Therapy Treatment Arm we do not have any measurements for this outcome|||||
139936|NCT00468819|Primary|Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group|Mean residence time of Gadobutrol in plasma expressed in h.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||hours||Inter-Quartile Range|Median
139714|NCT00472030|Primary|Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24.|Measurement of total body surface area affected by bullous pemphigoid active skin disease(active erosions, blisters, and/or lesions) was measured at Day 0 (prior to treatment with Omalizumab) and at 24 weeks (24 weeks is end of study).|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||percentage of active skin disease|||Number
139715|NCT00472030|Secondary|Decrease in Eosinophil Levels Following Treatment With Omalizumab.|The subject's eosinophil count measured at baseline was compared to the eosinophil count at week 8. A normal eosinophil count at the University of Iowa Hospital lab is 0-0.4 cells per microliter|Baseline, 24 weeks.|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||cells/microliter|||Number
139716|NCT00472030|Secondary|Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab.|Anti-BP180 IgG levels were completed using an Elisa assay. Anti-BP180 IgG levels were obtained prior to baseline and at week 16|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||units per milliliter|||Number
139717|NCT00472030|Primary|Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters.|The study subject underwent physical examination and was assessed for cessation of new blister formation via physical examination and photography.|Up to 24 weeks|The population analyzed included one subject who received Omalizumab treatment on Day 1, Week 2,4,6,8,10,12 and 14 and completed assessments through week 24. A second subject enrolled in the study and received one treatment with Omalizumab and was terminated from the study per investigator at Week 4.||weeks|||Number
139718|NCT00471822|Secondary|Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors|Participants for carriage of streptococcus pneumoniae were analyzed with respect to various risk factors which included number of bathrooms, number of siblings in the family (multiple siblings), size of the house in meter square (house area), frequency of hand wash in a day, bed sharing, smoking by family member, child breast feeding (breast milk practice), daycare attendance, vaccination for flu and pneumococcus, history of otitis media and upper respiratory infection (URI), antibiotic use and influenza virus infection.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. 'n' signifies those participants who were evaluated for the respective risk factor.||Percentage of Participants|||Number
139719|NCT00471822|Secondary|Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril|Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains.|Day 1|Evaluable population included all participants who met inclusion and exclusion criteria for the study.||Percentage of Participants|||Number
139720|NCT00471822|Secondary|Antibiotic-Resistant Streptococcus Pneumoniae Strains|Antibiotic resistance is defined as in vitro inhibition of a particular bacterial strain by a concentration of the drug associated with high likelihood of therapeutic failure. Antibiotic resistance for streptococcus pneumoniae was assessed against Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole. The standard breakpoint value (microbial growth inhibition zone) for Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole was not more than 8, 4, 13, 15 and 15 millimeter (mm) respectively. Percentage of participants with antibiotic-resistant streptococcus pneumoniae strains are reported. The same participant may have streptococcus pneumoniae strains which is resistance to more than one antibiotic.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.||Percentage of Carrier Participants|||Number
139721|NCT00471822|Secondary|Serotype Distribution of Streptococcus Pneumoniae Isolates|Streptococcus pneumoniae in swab culture of nasopharynx were serotyped. The assessment included 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F, non-vaccine, non-typable and missing serotypes. Percentage of participants under different vaccine serotypes in identified isolates of streptococcus pneumonia are reported.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, ‘N’ (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx.||Percentage of Carrier Participants|||Number
139722|NCT00471822|Primary|Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx|Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains.|Day 1|Evaluable population included all the participants who met inclusion and exclusion criteria for the study.||Percentage of Participants|||Number
139723|NCT00471718|Primary|Number of Patients Who Demonstrated Treatment Effectiveness Based on Prostate Specific Antigen (PSA) Response in Non-measurable Disease|Patients with a minimum 50% decline in PSA from pre-treatment baseline, confirmed by a second PSA 4 or more weeks later, measured in nanograms per milliliter of blood.|after four weeks|Men with non-measurable disease: all other lesions, bone lesions, leptomeningeal disease, cystic lesions, abdominal masses that are not followed by imaging techniques||participants|||Number
139724|NCT00471718|Secondary|Safety Profile Based on Number of Patients With Worst Grade Toxicities|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening or disabling, grade 5 = death)following NCI Common Toxicity Criteria|at 30 days after final treatment dose|||patients|||Number
144162|NCT00434876|Secondary|Insomnia Severity Index (ISI)|ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity.|Baseline, weeks 1, 3, 5, and 7 of treatment.|||units on a scale||Standard Deviation|Mean
139727|NCT00471718|Secondary|Number of Patients With Objective Response (CR & PR) by RECIST|Number of participants in each best tumor response category, RECIST criteria (v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in sum longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in sum LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of smallest sum of the LD of target lesions.|after four weeks|Participants with measurable disease who completed at least one cycle of treatment with tumor assessment.||participants|||Number
139728|NCT00471718|Primary|Maximum Tolerated Dose (MTD)|MTD is determined by the 3+3 study design, in which patients are enrolled in cohorts of 3. In any dose cohort, if 1 patient of 3 experience dose-limiting toxicity (DLT), three additional patients will be enrolled at the same dose level. Whenever >=2 of 6 subjects experience a DLT, then the maximum tolerated dose (MTD) has been exceeded. The MTD is generally one dose below that at which DLT occurs in >= 2 of 6 subjects in any given cohort.|up to four weeks|Phase I patients who received treatment||mg twice a day|||Number
139729|NCT00471705|Primary|Failure|At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment|Until 3 months posttreatment|||participants|||Number
139730|NCT00471705|Secondary|Recurrence|Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.|Until 6 months post-treatment|||Participants|||Number
139731|NCT00471705|Primary|Complete Clinical Response|"Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment.~Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment."|Until 6 months posttreatment|The efficacy of the treatments was calculated by intention to treat and by protocol.||participants|||Number
139732|NCT00471536|Secondary|Survival Time|The distribution of survival times will be estimated using the Kaplan-Meier method.|Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration|all participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
139733|NCT00471536|Secondary|Time to Disease Progression|The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.|Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration|All participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
139734|NCT00471536|Secondary|Duration of Response|The distribution of response durations will be estimated using the Kaplan-Meier method.|From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year|There were no responses.|||||
139735|NCT00471536|Secondary|Confirmed Tumor Response (CR and PR)|Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.|Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 year|||participants|||Number
139736|NCT00471536|Secondary|Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.|Every 4 weeks during treatment (maximum duration was 44 weeks)|Eighteen of the 19 participants accrued to the study were evaluable for adverse events.||participants|||Number
139737|NCT00471536|Primary|Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])|"Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria:~A Complete Response (CR) requires the disappearance of all target lesions.~A Partial Response (PR) requires >=30% decrease in the sum of the longest diameter of target lesions from baseline measurement.~All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response."|Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment.|All participants meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluated for response.||participants|||Number
139738|NCT00471497|Secondary|Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months||||||
139739|NCT00471497|Secondary|Rate Reduction in BCR-ABL Transcript Levels in Nilotinib Treatment Arms With Imatinib at 12 Months||Baseline, 12 months||||||
139740|NCT00471497|Secondary|Rate of Durable MMR at 24 Months.||Baseline, 24 months||||||
139741|NCT00471497|Primary|Molecular Response Rate (MMR) at 12 Months|Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson protooncogene)|Baseline, 12 months|Patients in the Full Analysis Set (FAS) were analyzed according to the treatment they were randomized to regardless of actual treatment received.||Percentage of participants||95% Confidence Interval|Number
139742|NCT00471445|Primary|Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo|"Cancer survivors who completed chemotherapy at least 1 month prior and had Chemotherapy Induced Peripheral Neuropathy (CIPN) (greater than or equal to 4 out of 10) were enrolled. CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average pain, numbness, or tingling in their hands and feet over the past 24 hours on an 11-point numeric rating scale at baseline and 6 weeks post intervention. CIPN ranges from 0 (no pain) to 10 (worst possible pain)."|Week 6 - Baseline|||units on a scale||95% Confidence Interval|Mean
139743|NCT00471380|Primary|Intra Ocular Pressure (IOP)|Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points|Baseline, end of each period (week 8, week 16, week 24)|||mm Hg (millimeters mercury)*week||Standard Deviation|Mean
139937|NCT00468819|Primary|Terminal Elimination Half Life Estimates of Gadobutrol by Age Group|Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||hours||Inter-Quartile Range|Median
139744|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
139745|NCT00471354|Secondary|CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
139746|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
139747|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
139748|NCT00471354|Secondary|Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores|Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.||units on a scale||Standard Deviation|Mean
139749|NCT00471354|Secondary|Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).||Spearman Correlation Coefficient|||Number
139750|NCT00471354|Primary|Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)|Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.|Baseline, 24 weeks|All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).||Spearman Correlation Coefficient|||Number
139751|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||Percentage of Participants||95% Confidence Interval|Number
139752|NCT00471328|Secondary|Overall Clinical Benefit (Complete Response [CR]/Partial Response [PR] or Stable Disease [SD]) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|The overall clinical benefit includes the best overall responses of CR, PR, or SD. The best overall responses of CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. The best overall response of SD must have at least one SD (or better) at least 6 weeks (or 6 months or 12 months as applicable) after randomization but before progression.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.||Percentage of Participants||95% Confidence Interval|Number
139781|NCT00471276|Primary|Number of Participants With Objective Response|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|Intent to Treat (ITT) population: all enrolled participants||Participants|||Number
150414|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
139753|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Local Investigator's Assessment Based on Treatment Crossover Analysis Set|The best overall response (CR/PR) must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||Participants|||Number
139754|NCT00471328|Secondary|Number of Responders With Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) From Central Radiology Review During Primary Analysis (Data Cut-off: June, 2008)|The best overall response is the best response recorded from randomization until disease progression. The CR/PR must be confirmed by at least two determinations at least 4 weeks apart before progression. Using modified RECIST criteria, a Complete Response is defined as disappearance of all lesions, and a Partial Response is defined as either 1) at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions or progression of non-target lesions or 2) disappearance of all target lesions but persistence of one or more non-target lesion(s).|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.||Participants|||Number
139755|NCT00471328|Primary|Progression-free Survival (PFS) From Local Investigator’s Assessment Based on Treatment Crossover Analysis Set|PFS is defined as the time from the first date of cross-over to nilotinib therapy from the control arm to the date of the first observation of documented disease progression. Tumor assessment was based on the local investigator's measurement using Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||days||95% Confidence Interval|Median
139756|NCT00471328|Secondary|Overall Survival for Treatment Crossover Analysis Set|For patients who crossed-over to nilotinib from the control arm, the overall survival was the time from the first dose date of nilotinib after switching from control arm to the date of death due to any cause. If death was not observed, the OS was censored at the latest date the patient was known to be alive.|Up to 34 months|Treatment Crossover Analysis Set: All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression.||days||95% Confidence Interval|Median
139757|NCT00471328|Secondary|Overall Survival During Core and Extension Phases of the Study|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact. This analysis included both Core and Extension data as well as survival follow up data.|Up to 50 months (including core, extension and follow up period)|Core Full Analysis Set (Core FAS): included all randomized patients included in the Core study. Analyses based on Core FAS does not account for treatment crossover i.e.pooling all data both before and after crossover. This analysis set was used to conduct an overall survival analysis.||days||95% Confidence Interval|Median
139758|NCT00471328|Secondary|Overall Survival Based on Primary Analysis (Data Cut-off:June, 2008)|Overall survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a participant is not known to have died, survival will be censored at the date of last contact.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized participants and was used as the primary efficacy population.||days||95% Confidence Interval|Median
139759|NCT00471328|Primary|Progression-free Survival (PFS) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|Up to 16 months|The intent to treat (ITT) population was defined as all randomized patients and was used as the primary efficacy population.||days||95% Confidence Interval|Median
139760|NCT00471315|Primary|The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.|The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.|3 months|||units on a scale||Standard Deviation|Mean
139761|NCT00471315|Secondary|Toleration of the Medication as Measured by the Duloxetine Compliance Rate|The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.|3 Months|||participants|||Number
139762|NCT00471276|Other Pre-specified|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|Baseline up to 1 year|ITT||Percentage of participants||95% Confidence Interval|Number
139763|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Satisfaction With Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.||Units on a scale||Full Range|Median
139764|NCT00471276|Secondary|Change From Baseline in CTSQ Score: Feelings About Side Effects|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.||Units on a scale||Full Range|Median
139765|NCT00471276|Secondary|Change From Baseline in Cancer Therapy Satisfaction Questionnaire (CTSQ) Score: Expectation of Therapy|CTSQ: included 3 multi-item subscales (Expectation of Therapy [ET], Satisfaction with Therapy [SWT], and Feelings about Side Effects [FSE]). Questions used 5-point scale from 1 'Never' to 5 'Always'. Scores averaged and transformed to 0-100 scale, with higher scores associated with better outcomes. Change from baseline=score for Cycle/Day minus baseline score.|Baseline, Day 15, Week 4 and 8, and every 8 weeks up to Month 36 or early termination|ITT; N=participants with baseline CTSQ data and data on any cycle/day; n=participants with baseline CTSQ data and data at corresponding cycle/day. Cycle 1 Day 15 measurements only for subset of participants with loco-regional superficial disease. Results reported for Cycles 1, 2, 3, 5 and 7 only, because (n) decreased substantially after Cycle 7.||Units on a scale||Full Range|Median
139766|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Upset by Hair Loss|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139767|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Systemic Therapy Side Effects|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139768|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Breast Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139769|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Arm Symptoms|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139770|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Functioning|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139782|NCT00471146|Secondary|Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months||||||
139938|NCT00468819|Primary|Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group|Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||µmol*h/L||Inter-Quartile Range|Median
139771|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Sexual Enjoyment|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139772|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ-BR23 Score: Future Perspective|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139773|NCT00471276|Secondary|Change From Baseline in EORTC-QLQ Companion Breast Cancer Module (EORTC-QLQ-BR23) Score: Body Image|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139774|NCT00471276|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, every 4 weeks up to Month 31 or early termination|ITT; N=participants who completed the scales at both baseline and any cycle; n=number of participants who completed the scales at both baseline and the respective cycle. Results reported for Cycles 1 through 6 only, because (n) decreased substantially after Cycle 6.||Units on a scale||Full Range|Median
139775|NCT00471276|Secondary|Number of Participants With Objective Response for Subgroup of Participants Whom Sunitinib Was at Least a Third Line Therapy|Number of participants with objective response based assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT; N=participants who received at least 2 lines of prior chemotherapy for advanced/metastatic disease and had post baseline tumor assessment||Participants|||Number
139776|NCT00471276|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS (Months)=(death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline until death (up to Month 34)|ITT||Months||95% Confidence Interval|Median
139777|NCT00471276|Secondary|Duration of Response (DR)|Time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or death due to any cause, whichever occurred first. DR calculated as (Weeks)=(end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Baseline up to Month 34 or early termination|ITT; N=participants with objective response||Weeks||Full Range|Median
139778|NCT00471276|Secondary|Progression-Free Survival (PFS)|Time from date of randomization to date of first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months)=(first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 34|ITT||Months||95% Confidence Interval|Median
139779|NCT00471276|Secondary|Number of Participants With Objective Response of Superficial Lesions|Number of participants with objective response based assessment of confirmed CR or PR of superficial lesions according to RECIST. Superficial lesions included skin lesions, chest wall lesions, and breast lesions and lymph nodes if followed up by physical examination.|Baseline, every 4 weeks up to Month 34|ITT; Number of participants analyzed equaled (N =) participants who had superficial lesions with post baseline follow-up assessments of those lesions.||Participants|||Number
139780|NCT00471276|Secondary|Number of Participants With Clinical Benefit|The sum of participants with confirmed CR, PR, and stable disease (SD) greater than (>) 6 months according to RECIST. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference smallest sum of longest dimensions since treatment started.|Baseline, Week 9, and every 8 weeks up to Month 34|ITT||Participants|||Number
139817|NCT00470470|Secondary|Time to Progression|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. Time to progression will be estimated using the Kaplan-Meier method.|Time from the treatment start to the date of disease progression|||weeks||Inter-Quartile Range|Mean
144163|NCT00434876|Primary|Sleep Efficiency (From an In-laboratory Polysomnogram)|The fraction of time spent asleep to the total time in bed (%).|Baseline, and week 8 of treatment.|||percentage||Standard Deviation|Mean
139783|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Millimeter (mm)||Standard Deviation|Mean
139784|NCT00471146|Secondary|Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
139785|NCT00471146|Secondary|Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
139786|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
139787|NCT00471146|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Units on a scale||Standard Deviation|Mean
139788|NCT00471146|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline until death or at least 1 year after the randomization of last participant|DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||Weeks||95% Confidence Interval|Median
139789|NCT00471146|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, every 8 weeks until tumor progression or death|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
139818|NCT00470470|Primary|Objective Response Rate|Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon two-stage minimax design will be employed.|Every 6 weeks for the first 3 courses and then every 12 weeks thereafter|||participants|||Number
139819|NCT00470158|Secondary|Percent Anemic||6 months||||||
139820|NCT00470158|Secondary|Change in Zinc Status||6 months||||||
139821|NCT00470158|Secondary|Change in Hemoglobin||6 months||||||
139790|NCT00471146|Secondary|Progression Free Survival (PFS)|"Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until disease progression or at least 1 year after the randomization of last participant|ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
139791|NCT00471146|Primary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or at least 1 year after the randomization of last participant|Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
139792|NCT00471107|Primary|Verbal Memory|The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled).|24 hours|All subjects in this group for whom data were obtained were analyzed||Words recalled||Standard Deviation|Mean
139793|NCT00471068|Primary|Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment|IOP measured at week 6 minus IOP measured at baseline|At week 0 and week 6|||millimeters mercury (mm Hg)||Standard Deviation|Mean
139794|NCT00470847|Secondary|Overall Survival|Overall average length of participant survival after protocol initiation|Participants were followed for an average of 3.8 years|||Months||Full Range|Median
139795|NCT00470847|Secondary|Percentage of Participants Having Non-Central Nervous System Sites as the Site of First Progression||5 years|||percentage of participants|||Number
139796|NCT00470847|Secondary|Percentage of Participants Having Central Nervous System as the Site of the First Progression||5 years|||percentage of participants|||Number
139797|NCT00470847|Secondary|Objective Response Rate in Central Nervous System Sites|Objective Response Rate was defined using volumetric response as the following: Complete Response (CR) is the disappearance of all target lesions, stable/responsive non-target lesions, and no new lesions. Partial response (PR) is at least a 50% reduction in the sum of the target lesions, stable/responsive non-target lesions, and no new lesions. Stable Disease (SD) is neither CR PR or Progressive Disease (PD). And Progressive Disease (PD) is at least 40% increase in sum of target lesionsor the appearance of any new lesion >=6mm in the longest dimension. If a patient progressed in a non-central nervous system(CNS) site first, died, or withdrew from the study for any reason after the first dose of drug was administered, and before a CR or PR in the central nervous system was determined, she was considered a CNS non-responder.|5 years|28 participants had measurable disease out of the 35 participants enrolled.||percentage of participants||95% Confidence Interval|Number
139798|NCT00470847|Secondary|Progression Free Survival|Progression Free Survival is the time from date of start of treatment to the date of the first documented progression or death due to any cause. If a patient has not progressed or died, progression free survival is censored at the time of last tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years|||months||Full Range|Median
139799|NCT00470847|Primary|The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer.|The maximum tolerated dose is defined as :The highest dose of a drug or treatment that does not cause unacceptable side effects.|5 Years|||milligrams|||Number
139800|NCT00470834|Secondary|Number of Participants With Metastatic Disease|Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.|Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)|ITT Population||participants|||Number
139801|NCT00470834|Secondary|Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42|Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 6, 12, 18, 21, and 42|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.||Nanograms per milliliter (ng/mL)||Full Range|Median
139802|NCT00470834|Secondary|Number of Participants With PSA Response|PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.|Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)|ITT Population||participants|||Number
139822|NCT00470158|Primary|Incidence of Diarrhea|A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days.|6 months|||episodes|||Number
139939|NCT00468819|Primary|Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.|From injection to 8 hours after Gadobutrol injection|Final PK analysis set||L/kg||Inter-Quartile Range|Median
139803|NCT00470834|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)|ITT Population||Days||Standard Deviation|Mean
139804|NCT00470834|Primary|Time to Disease Progression|Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter [ng/mL] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.|Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)|Intent-to-Treat (ITT) Population: all participants randomized to study treatment||Days||Standard Deviation|Mean
139805|NCT00470626|Secondary|Mean Time to Retrieval Attempt|"Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made.~A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made."|up to 12 months|||days||Standard Deviation|Mean
139806|NCT00470626|Secondary|Successful Retrieval|Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).|up to 12 months|129 patients received a filter. Filters were placed as permanent devices in 34 patients and as temporary devices in 95 patients. A decision to retrieve a filter was made by the physician once the patient’s medical condition warranted it (once the fliter was no longer required). Filter retrieval was attempted in 58 of 95 patients.||successful retrievals|||Number
139807|NCT00470626|Primary|Major Adverse Event|Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.|up to 12 months|||participants|||Number
139808|NCT00470600|Secondary|Patient Demand of Narcotic Use (Post-operative Period, From Hour 6 to 28).|Patient demand of narcotic used by patients in each treatment group for analgesia, post-surgery.|Study hour-6 to hour-28|Demand of narcotic use was determined by PCA records or by chart if patient requested and not via PCA.||milligrams||Standard Deviation|Mean
139809|NCT00470600|Secondary|Secondary Endpoint: AUC-VAS at Rest (Post-operative Period, Hours 6-28)|"Measurement of the patient’s self assessment of pain at rest using a visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
139810|NCT00470600|Primary|AUC-VAS With Movement (Post-operative Period, Hour-6-28)|"Measurement of the patient’s self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from No pain (0 mm) to Worst possible pain (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery [variable since every surgery has a unique length of time even if it is the same procedure] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint)."|Study hour-6 through hour-28|Efficacy analyses were performed on the Intent to Treat (ITT) population and the Efficacy Evaluable Population (EEP). All randomized patients who received at least a partial dose of CTM were included in the ITT analyses. All data below represents the ITT analyses.||AUC-VAS pain v. time (mm*hr)||Standard Error|Least Squares Mean
139811|NCT00470535|Secondary|Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade||At Baseline|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
139812|NCT00470535|Secondary|Correlation of Smoking Status With Overall Survival||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
139813|NCT00470535|Secondary|Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy||Every 3 weeks|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
139814|NCT00470535|Secondary|Median Overall Survival||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
139815|NCT00470535|Secondary|Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria||After every cycle|This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.|||||
139816|NCT00470535|Primary|Progression-free Survival||Every cycle|All treated and eligible patients||months||95% Confidence Interval|Median
139823|NCT00470106|Secondary|Mean Test Score From a Test of Functional Capacity (Ability to Perform Daily Activities).|This is a role play demonstration test that measures how well someone handles social communication in daily life. The scores reflect overall effectiveness and are the mean number scored across different social situations with a range of 0-5 with higher being better. There are no norms for this test.|Assessments at endpoint (12 weeks).|||number correct||Standard Deviation|Mean
139824|NCT00470106|Primary|Mean Test Scores for Facial Emotion Identification.|This is a test of social cognition that measures the ability to identify the emotion shown in photos of still faces. The construct of interest is facial affect perception. It is an experimental measure and does not have norms or cut-offs. The range of accuracy scores is 0-56 with higher being better.|Assessments for end point (12 weeks).|||number of correct answers||Standard Deviation|Mean
139825|NCT00470067|Primary|Response (Complete and Partial)|Response Rate|Every 28 days|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
139826|NCT00470054|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|"The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Assessed during treatment|All 44 participants who received treatment were analyzed (including ineligible participants).||participants|||Number
139827|NCT00470054|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death (up to 3 years)|All eligible participants were analyzed.||weeks||95% Confidence Interval|Median
139828|NCT00470054|Secondary|Response to Therapy|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria."|Assessed every 2 cycles (up to 3 years)|All eligible participants were analyzed.||participants|||Number
139829|NCT00470054|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.~Progression is defined as in the primary outcome measure."|Time from registration to progression (up to 3 years)|All eligible participants were analyzed.||weeks||95% Confidence Interval|Median
139830|NCT00470054|Primary|6 Week Progression Free Survival|"Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.~Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions."|6 weeks|All eligible participants were analyzed.||percentage of participants||95% Confidence Interval|Number
139831|NCT00469898|Secondary|Overall Survival||On study date to death|||Months||Full Range|Median
139832|NCT00469898|Secondary|Time to Progression|Time to progression in months|9.9 months (on study date to progression)|Patients who has progression||Months|Participants|Full Range|Median
139833|NCT00469898|Secondary|Number of Patients With Adverse Events|Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event|date off treatment or progression of disease, up to 18 weeks|||participants|||Number
139834|NCT00469898|Primary|Patient Response|"Patient response to treatment:~Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD"|1.66 months (average duration, on treatment date to best response date)|||participants|||Number
139835|NCT00469859|Primary|>80% Inhibition of FLT3 Phosphorylation in a Majority of Post-treatment Trough Time Points|FLT3 inhibition is determined in patients receiving lestaurtinib by measuring FLT3 plasma inhibitory activity (PIA). For PIA predictive modeling, a random effects linear regression model will be used to describe the relationship between PIA and Pharmacokinetic (PK) levels for each of the 5 trough plasma samples collected for each patient|Course 1 day 7, day 14, day 21, and day 28.|||participants|||Number
139836|NCT00469859|Primary|Dose-limiting Toxicity|Number of patients with dose-limiting toxicity (DLT)|28 days|||participants|||Number
139837|NCT00469833|Secondary|HbA1c Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Type 2 diabetic subjects had HbA1c measured before and after 2 months of basal insulin glargine treatment.|2 months|||% glycosylated hemoglobin||Standard Error|Mean
139838|NCT00469833|Primary|Insulin Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes|||pmol/L||Standard Error|Mean
139866|NCT00468208|Secondary|Disease Improvement|"Disease improvement was measured by a reduction in the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG).~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
139839|NCT00469833|Primary|C-peptide Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes|||nmol/L||Standard Error|Mean
139840|NCT00469833|Primary|ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia.|Subjects had glucose clamps for 270 minutes with serial sampling of blood for measurement of insulin and C-peptide. At 90 minutes into the clamp they consumed 75 g of oral glucose solution. Meal-stimulated insulin secretion was summarized as the mean plasma C-peptide from 90-270 minutes. This outcome measure was compared for each subject before treatment and after 2 months of insulin treatment to lower blood glucose. Subjects were started on 20 units of insulin glargine after their first visit and asked to measure their morning blood glucose daily. The dose of insulin was increased in increments of 4-6 units every 3 days targeting an average morning glucose level of less then 120 mg/dl. After 2 months of treatment the primary outcome was repeated with a second glucose clamp / oral glucose tolerance test, identical to the first.|180 minutes|||pmol/min||Standard Error|Mean
139841|NCT00469508|Other Pre-specified|BDI Score|Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.|From baseline to end of treatment period (week 12).|Intention to treat, LOCF||units on a scale||Standard Deviation|Mean
139842|NCT00469508|Other Pre-specified|VAS Score|To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.|baseline and last observation during the 12 week treatment period|Intention to treat, LOCF||units on a scale||Standard Deviation|Mean
139843|NCT00469508|Secondary|Retention|The number of persons who completed the medication phase of the trial (12 weeks of medication).|12 weeks|Intention to treat||participants|||Number
139844|NCT00469508|Primary|Clean Urine Drug Screen|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|From randomization to end of week 12|Intention to treat||Clean urine drug screens|Participants|Standard Deviation|Mean
139845|NCT00469456|Secondary|Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12|The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication.|Baseline to Week 12|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
139846|NCT00469456|Primary|Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12|FLCI is a standardized & validated instrument for evaluating functional communication in pts with moderate-to-severe Alzheimer's that can be used to obtain Baseline information & to track patients' capabilities thereafter. The FLCI evaluates 10 areas: greeting and naming, answering questions, writing, sign comprehension, object-to-picture matching, word reading and comprehension, following commands, pantomime, gesture, and conversation. The FLCI total score ranges from 0 to 87, a higher score denotes better functional communication, and takes approximately 30 minutes to complete.|Baseline to Week 12|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population will consist of all patients in the Safety Population who had at least one post-Baseline assessment of the primary efficacy parameter, FLCI. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
139847|NCT00469391|Primary|Percent Excess Weight Loss (%EWL) at Week 12|Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)|3 months|||Percentage of Excess Weight Loss||Standard Deviation|Mean
139848|NCT00468312|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||liters/minute||Standard Deviation|Least Squares Mean
139891|NCT00468845|Other Pre-specified|Incision Length Correlated With Worst Pain|Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata.|Day 1|mITT||Centimeter (cm)||Standard Error|Least Squares Mean
144238|NCT00434226|Secondary|Incidence of Grade ≥ 3 Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
139849|NCT00468312|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age. The analysis population included subjects who were randomized to treatment, answered the RQL questionnaire both at baseline and post baseline visits and were at least 18 years of age.||Score on a scale||Standard Deviation|Least Squares Mean
139850|NCT00468312|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||Score on a scale||Standard Deviation|Least Squares Mean
139851|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||Score on a scale||Standard Deviation|Least Squares Mean
139852|NCT00468312|Primary|Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Screening through 15 days daily|All randomized participants were to be included in the analysis (intent-to-treat principle). However, participants with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||Score on a scale||Standard Deviation|Least Squares Mean
139853|NCT00468299|Secondary|Complete Abortion at One Week|Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound|3 weeks|Per protocol||participants|||Number
139854|NCT00468299|Primary|Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.||24-48 hrs|||participants|||Number
139855|NCT00468286|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|1 year|||participants|||Number
139856|NCT00468286|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline up to 1 year|||participants|||Number
139857|NCT00468286|Secondary|Serum Levels of Luteinizing Hormone (LH) Over Time||1 year|||IU/L||Full Range|Median
139858|NCT00468286|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) Over Time||1 year|||IU/L||Full Range|Median
139859|NCT00468286|Secondary|Serum Levels of PSA Over Time||1 year|||ng/mL||Full Range|Median
139860|NCT00468286|Secondary|Probability of no PSA Failure|Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).|1 year|||percentage of participants||95% Confidence Interval|Mean
139861|NCT00468286|Secondary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.|1 year|||percentage of participants||95% Confidence Interval|Mean
139862|NCT00468286|Secondary|Serum Levels of Testosterone Over Time||1 year|||ng/mL||Full Range|Median
139863|NCT00468286|Primary|Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.|1 year|||percentage of participants||95% Confidence Interval|Mean
139864|NCT00468208|Secondary|Disease Relapse|"Disease relapse was measured by a rise in the Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) of greater than or equal to 1 after achieving remission.~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
139865|NCT00468208|Secondary|Meeting Common Closing|The number of subjects that reached the common closing date.|Number assessed at the time of common closing, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
139867|NCT00468208|Secondary|Disease Remission|"Disease remission was measured by a Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) of 0.~The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63."|Measured monthly until common closing or early termination,up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
139868|NCT00468208|Primary|Safety of Abatacept - Number of Participants With Adverse Events|"This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following:~Infection~Infusion reactions~Cytopenias~Transaminase elevation~Skin reactions~GI side effects~Malignancy~All adverse events were reportable for this study."|Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months.|This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations.||participants|||Number
139869|NCT00469274|Primary|Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria.|Defined as a positive nasopharyngeal culture or PCR for B. pertussis at any time point, a two-fold rise in the anti-PT IgG titer between acute and convalescent sera, or a single acute or convalescent anti-PT IgG titer of ≥94 EU. Post hoc, a modified definition was devised because of concern that the serologic criteria used in the primary definition might actually represent acquisition of pertussis infection prior to the intervention. The modified definition of pertussis excluded an acute anti-PT IgG titer of ≥94 EU and an acute nasopharyngeal swab that was positive for B. pertussis by PCR.|In the 21 days following exposure identification|||participants|||Number
139870|NCT00469209|Secondary|Time to Toxicity|The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.|Baseline to event occurence (assessed weekly first 30 days)||||||
139871|NCT00469209|Primary|Number of Patients Reaching Complete Response (CR)|Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with <5% plasma cells, <1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.|Baseline through Day 180, with assessments at Day 90 and Day 180|Analysis was per protocol.||participants|||Number
139872|NCT00469092|Secondary|Number of Subjects Reporting Treatment Emergent Adverse Events|Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.|Weeks 0-26|The safety analysis population consists of all subjects exposed to trial products.||participants|||Number
139873|NCT00469092|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.|Weeks 0-26|||events|||Number
139874|NCT00469092|Secondary|Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)|Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||scores on a scale||Standard Error|Mean
139875|NCT00469092|Secondary|Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)|The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||participants|||Number
139876|NCT00469092|Secondary|9-point Self-measured Plasma Glucose Profiles|Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.|After 26 weeks of treatment|Intention to Treat, Last Observation Carried Forward population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||mmol/L||Standard Error|Mean
139877|NCT00469092|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.|After 26 weeks of treatment|Intention to Treat (Last Observation Carried Forward) population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.||percentage of total haemoglobin||Standard Deviation|Least Squares Mean
139933|NCT00468819|Secondary|Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group|In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS||Participants|||Number
139878|NCT00469079|Secondary|Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week.|Changes in craving and withdrawal symptoms were assessed at the time of discontinuation of usual brand cigarettes (i.e., baseline compared to week 1). Assessments were made using the Minnesota Nicotine Withdrawal Scale, which measures abstinence effects from usual brand cigarettes. Total Score: Range of scores is from 0 to 28. All items with the exclusion of craving are summed. Craving Score: Range of score is from 0 to 4. A higher score would indicate more severe withdrawal.|Baseline and 1 week|All subjects completing the intervention||units on a scale||Standard Error|Mean
139879|NCT00469079|Primary|Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention.|This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected at each visit to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the end of treatment and at each of the 2 follow-up visits (week 1 and 11 post-intervention). Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report (i.e., no cigarettes smoked) and confirmed by an exhaled CO of less than 8 ppm. At the follow-up visits, abstinence was also confirmed by both exhaled CO concentrations and urinary cotinine concentration (<35 ng/mL).|12 weeks|Intent to treat model.||participants|||Number
139880|NCT00469079|Primary|Product Use at Week 4 of Intervention|Self-reported daily use of the assigned study product. Range of scores is from 0 to about 20. Higher scores do not represent either a better or a worse outcome. Higher number of product used per day may indicate higher abuse liability of the product but may lead to a greater suppression in usual brand cigarette smoking. Lower number of product use per day may indicate lower abuse liability but may lead to lower suppression of usual brand smoking.|4 weeks|All subjects who completed intervention.||uses per day||Standard Error|Least Squares Mean
139881|NCT00469079|Primary|Toxicant Exposure by Products|Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.|Baseline, 4 weeks|All subjects who continued in the protocol were analyzed. Non-parametric Kruskal-Wallis method of analysis was used.||ng/ml||95% Confidence Interval|Geometric Mean
139882|NCT00468845|Secondary|Total Clinically Meaningful Event (CME) Score|Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139883|NCT00468845|Secondary|Incidence of Chronic Post-operative Pain|Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery.|3 and 6 Months PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed. Participants reported as no chronic pain in the 3 month visit were carried over to the missing data at 6 month visit.||Percentage of participants|||Number
139884|NCT00468845|Other Pre-specified|Neuropathic Pain Symptom Inventory (NPSI)|Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139885|NCT00468845|Secondary|Time to Actual Discharge|Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery.|Day 1 up to Day 7 PS|mITT||Hours||Standard Error|Mean
139886|NCT00468845|Secondary|Time to Meet Hospital Discharge Criteria|Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids.|Day 1 up to Day 7 PS|mITT||Hours||Standard Error|Mean
139887|NCT00468845|Secondary|Quality of Life Using EuroQol (EQ-5D) Health State Profile|"Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, confined to bed). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata."|Discharge (day 3 up to day 7 PS) and day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139888|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139889|NCT00468845|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Discharge (day 3 up to day 7 PS), Day 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139890|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 28 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 28 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139892|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - End of Treatment|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 1 up to Day 28 PS|Safety population||Percentage of participants|||Number
139893|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 14 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 14 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139894|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 7 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 7 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139895|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Discharge|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Discharge (day 3 up to day 7 PS)|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139896|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 5 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 5 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139897|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 4 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 4 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139898|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 3 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 3 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139899|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 2 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 2 PS|mITT; N=number of evaluable participants analyzed;||Percentage of participants|||Number
139900|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Day 1 PS|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1 PS|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139901|NCT00468845|Secondary|Participant Satisfaction With Study Medication - Surgery Day|Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1.|Day 1|mITT; N=number of evaluable participants analyzed||Percentage of participants|||Number
139902|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 28 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 28 PS|Safety population||Percentage of participants|||Number
139903|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 14 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 14 PS|Safety population||Percentage of participants|||Number
139904|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|"m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).~LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139905|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Day 7 PS|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Day 7 PS|Safety population||Percentage of participants|||Number
139906|NCT00468845|Other Pre-specified|Percentage of Participants With Wound Healing Complications - Discharge|Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication.|Discharge (day 3 up to day 7 PS)|Safety population all participants who were administered at least one dose of double blind medication, and for whom at least one post-baseline safety evaluation was obtained were included.||Percentage of participants|||Number
139907|NCT00468845|Secondary|Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139908|NCT00468845|Secondary|Sleep Interference|Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139909|NCT00468845|Secondary|Worst Daily Pain|Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score.|Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Deviation|Mean
139910|NCT00468845|Secondary|Average Daily Pain|Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139911|NCT00468845|Secondary|Timed Up-and-Go (TUG)|Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Seconds||Standard Error|Least Squares Mean
139912|NCT00468845|Secondary|Percent Change From Baseline in Peak Expiratory Flow|Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.||L/min||Standard Error|Least Squares Mean
139913|NCT00468845|Secondary|Non-opioid Rescue Medication - Ibuprofen|The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Grams (g)||Standard Deviation|Mean
139914|NCT00468845|Secondary|Anxiety Before and After Surgery|Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata|Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139915|NCT00468845|Secondary|Non-opioid Rescue Medication - Paracetamol|The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications.|24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Grams (g)||Standard Deviation|Mean
139916|NCT00468845|Secondary|Integrated Analgesic Score|The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|0-24, 24-48, 48-72 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139917|NCT00468845|Secondary|Total Cumulative Dose of Opioids Following Surgery|Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|24, 48 Hours PS, Discharge (day 3 up to day 7 PS)|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||milligram (mg)||Standard Error|Least Squares Mean
139918|NCT00468845|Secondary|Area Under the Curve (AUC) of Pain at Rest During the First Two Days of Hospital Stay|Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139940|NCT00468819|Primary|Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group|Apparent volume of distribution at steady state expressed in L after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set||L||Inter-Quartile Range|Median
139919|NCT00468845|Secondary|Current Pain at Rest|Pain reported by participants at rest (numeric rating scale (NRS) – Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|8, 16, 24, 32, 40, 48 hours PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139920|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test|Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139921|NCT00468845|Secondary|Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting|Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|48 +/- 4 hours PS|mITT; N=number of evaluable participants analyzed||Units on a scale||Standard Error|Least Squares Mean
139922|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test|Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1, up to 7 days PS, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.||Units on a scale||Standard Error|Least Squares Mean
139923|NCT00468845|Secondary|Current Pain - Pain With Movement Caused by Sitting|Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.|Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS|mITT; n = number of evaluable participants analyzed for the given time point; N=number of evaluable participants analyzed; Results presented for only those timepoints PS where at least 4 participants in each treatment arm completed the questionnaire at baseline and respective time point.||Units on a scale||Standard Error|Least Squares Mean
139924|NCT00468845|Primary|Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).~Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata."|Day 2 (24 hours post surgery [PS])|Modified intent-to-treat (mITT) population: participants who received at least 1 dose study drug, had at least 1 post baseline safety and efficacy evaluation, took all pre-surgery medication, had no complications during surgery with discontinuation, no PS infection with additional hospitalization/readmission, had primary efficacy measurement PS||Units on a scale||Standard Error|Least Squares Mean
139925|NCT00468819|Secondary|Number of Participants With Change in Diagnostic Confidence by Age Group|In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened).|up to 1 hour after Gadobutrol injection|FAS||Participants|||Number
139926|NCT00468819|Secondary|Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)|In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
139927|NCT00468819|Secondary|Post-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
139928|NCT00468819|Secondary|Pre-Contrast Lesion Characterization by Age Group|In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
139929|NCT00468819|Secondary|Post-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
139930|NCT00468819|Secondary|Pre-Contrast Delineation of Lesion/Vessel Border by Age Group|In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
139931|NCT00468819|Secondary|Post-Contrast Lesions by Location and by Age Group|Number of lesions on post-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
139932|NCT00468819|Secondary|Pre-Contrast Lesions by Location and by Age Group|Number of lesions on pre-contrast images by organ location and age group.|up to 1 hour after Gadobutrol injection|FAS||Lesions|||Number
139941|NCT00468819|Primary|Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group|Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.|From injection up to 8 hours after Gadobutrol injection|Final PK analysis set||L/h/kg||Inter-Quartile Range|Median
139944|NCT00468728|Secondary|Recurrence|Percentage of subjects with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The analysis population is mITT, for subjects who met the primary endpoint of cure, was analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.||Percentage of Participants|||Number
139945|NCT00468728|Primary|Cure Rate at End of Therapy|Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
139946|NCT00468676|Primary|Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months|"Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 months and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||percent glycated hemoglobin||Standard Deviation|Mean
139947|NCT00468676|Primary|LDL Cholesterol at Baseline and 12 Months|"LDL Cholesterol was measured at Baseline and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline and 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||mg/dL||Standard Deviation|Mean
139948|NCT00468676|Primary|Systolic Blood Pressure at Baseline, 6 Months and 12 Months|"Systolic Blood Pressure was measured at Baseline, 6 months and 12 months~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||mmHg||Standard Deviation|Mean
139949|NCT00468676|Primary|Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months|"SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.~For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes."|Measured at Baseline, 6 Months, 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||scores on a scale||Standard Deviation|Mean
139950|NCT00468676|Secondary|Health Care Costs|Mean total outpatient costs for 2 years post baseline adjusted for age, gender and previous 12 months of outpatient costs|Cumulative outpatient costs over 24 months|||US dollars||Standard Deviation|Least Squares Mean
139951|NCT00468676|Secondary|Functional Impairment|"Disability was measured by the Sheehan Disability scale which measures the extent to which health interferes with social, vocational and familial functioning each on a 0 to 10 Likert scale where 0 is not at all and 10 is extremely. This scale consists of 3 items which are averaged together to create the average disability score, which ranges from 0 to 10."|Measured at Months 6, 12 months|||units on a scale||Standard Deviation|Mean
139952|NCT00468676|Primary|Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c|A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.|Baseline to 12 months|This was an intent to treat analysis of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes||unitless||95% Confidence Interval|Number
139953|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139997|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
139954|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 or 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (hard enough for penetration [but not completely hard]) or 4 (completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3 or 4)/ (number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139955|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
139956|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 4 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 4 (4= completely hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 4)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
139957|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139958|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 3 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 3 (3= hard enough for penetration [but not completely hard]) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 3)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139959|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139960|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 2 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation - Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 2 (2= hard, but not hard enough for penetration) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 2)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||Per-patient percentage||Standard Deviation|Mean
139961|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139998|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Open-label Phase)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
139962|NCT00468650|Secondary|Mean Per-Patient Percentage of Grade 1 Events in Erection Hardness Grading Scale (EHGS) Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of Grade 1 (1=increase in size, but not hard) erection hardness based on occasions: 100*(number of occasions where Erection Hardness Scale Answer 1)/(number of occasions where Erection Hardness Scale was answered)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
139963|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139964|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 (Q3) Based on Attempts With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Q3 based on attempts with sexual stimulation (SS): 100* (number of attempts with SS where SEP Q3 [Did your erection last long enough for you to have successful intercourse?] = Yes)/(number of attempts with SS where SEP Q3 was answered Yes or No)|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139965|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [“Were you satisfied with this sexual encounter?”] = “Yes”) / (number of occasions where SEP Question 5 was answered “Yes” or “No”)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139966|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 5 Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 5 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 5 [“Were you satisfied with this sexual encounter?”] = “Yes”) / (number of occasions where SEP Question 5 was answered “Yes” or “No”)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
139967|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [“Were you satisfied with the hardness of your erection?”] = “Yes”) / (number of occasions where SEP Question 4 was answered “Yes” or “No”).|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139968|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 4 Based on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 4 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 4 [“Were you satisfied with the hardness of your erection?”] = “Yes”) / (number of occasions where SEP Question 4 was answered “Yes” or “No”).|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139969|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
144239|NCT00434226|Secondary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
139970|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 3 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 3 [Did your erection last long enough for you to have successful intercourse?] = Yes) / (number of occasions where SEP Question 3 was answered Yes or No)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||per-patient percentage||Standard Deviation|Mean
139971|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [“Were you able to insert your penis into your partner’s vagina?”] = “Yes”) / (number of occasions where SEP Question 2 was answered “Yes” or “No”).|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139972|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 2 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to SEP Question 2 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 2 [“Were you able to insert your penis into your partner’s vagina?”] = “Yes”) / (number of occasions where SEP Question 2 was answered “Yes” or “No”).|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139973|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 Based on Occasions With Sexual Stimulation- Change From Week 2|Mean change: mean change at each visit minus mean at Week 2. Percent of “Yes” responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139974|NCT00468650|Secondary|Mean Per-Patient Percentage of 'Yes' Responses to Sexual Encounter Profile (SEP) Question 1 on Occasions With Sexual Stimulation- Change From Baseline|Mean change: mean change at each visit minus mean at baseline. Percent of “Yes” responses to Question 1 based on occasions (= sexual stimulation): 100*(number of occasions where SEP Question 1 [Were you able to achieve at least some erection (some enlargement of the penis)?] = Yes) / (number of occasions where Question 1 was answered Yes or No)|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||per-patient percentage||Standard Deviation|Mean
139975|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139976|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Relationship Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Relationship domain was sum of scores for Questions 7, 8 and 9 from the Sex-Q. Score range: 1 to 5; total 3 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139977|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
140066|NCT00468481|Primary|Red Blood Cell (RBC) Folate Level at 24 Weeks|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||95% Confidence Interval|Least Squares Mean
139978|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Satisfaction Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions (q). Sex-Q Satisfaction domain:sum of scores for q 10, 11, 12, 13, 14 and 15 from Sex-Q. Score range:1 to 5; total 6 to 30. Higher score indicates better outcome|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139979|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain- Change From Week 2|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139980|NCT00468650|Secondary|Sexual Experience Questionnaire (Sex-Q): Erection Domain - Change From Baseline|Sexual Experience Questionnaire (Sex-Q) is a self-administered questionnaire designed to assess functional, emotional, and social aspects of sexual experience. Sex-Q includes 15 questions. Sex-Q Erection domain: sum of scores for Questions 1, 2, 3, 4, 5 and 6 from the Sex-Q. Score range: 1 to 5; total 6 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139981|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score- Change From Week 2|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 4 and Week 6|||score on scale||Standard Deviation|Mean
139982|NCT00468650|Secondary|Quality of Erection Questionnaire (QEQ): Total Score - Change From Baseline|QEQ is a self-administered scale used to assess erection hardness and overall quality of erections. The QEQ total score is defined as the sum of the scores from QEQ Questions 1-6. Score range: 1 to 5. Higher score indicates better outcome. Raw QEQ score ranges from 6-30 and is transformed onto a 0-100 scale.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139983|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139984|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Overall Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is overall satisfaction. IIEF Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139985|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139986|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is intercourse satisfaction. IIEF Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. Higher score indicates better outcome.|Week 2, Week 4, and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
140523|NCT00465088|Primary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12|(Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
139987|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139988|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Sexual Desire Domain Score- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one of which is sexual desire. IIEF Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139989|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Week 2|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139990|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Orgasmic Function Domain- Change From Baseline|IIEF is a self-administered scale to assess erectile functioning. IIEF includes 15 questions and addresses the 5 relevant domains of male sexual function, one is orgasmic function. IIEF Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139991|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Week 2|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, the last assessment among those collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2||score on scale||Standard Deviation|Mean
139992|NCT00468650|Secondary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score - Change From Baseline at Weeks 2, 4 and 6|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 2, Week 4 and Week 6|MITT population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. Week 6 Endpoint = last observation recorded after Week 2||score on a scale||Standard Deviation|Mean
139993|NCT00468650|Primary|International Index of Erectile Function (IIEF), Erectile Function (EF) Domain Score- Change From Baseline to Week 6 Last Observation Carried Forward (LOCF)|IIEF is a self-administered scale designed to assess erectile functioning: includes 15 questions on 5 relevant domains of male sexual function; one is erectile function (EF). IIEF-EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. Higher score indicates better outcome.|Week 6 LOCF|Modified intent to treat (MITT) population consists of subjects in the safety population who provided at least 1 post baseline efficacy assessment. The Week 6 Last Observation Carried Forward (LOCF) value is the last post-baseline value, ie, last assessment collected at visits after Visit 1. Week 6 Endpoint = last observation recorded after Week 2.||score on scale||Standard Deviation|Mean
139994|NCT00468585|Primary|Overall Objective Response|This is defined as the percentage of patients who achieve either an objective complete or partial target lesion response that is confirmed based on the RECIST criteria.|2 years|||participants|||Number
139995|NCT00468559|Secondary|Severity of Feeding Difficulties as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|83 patients were analyzed at the screening timepoint, 83 patients were analyzed at week 1 and 78 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
139996|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Open-label Phase Endpoint)|Symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, The score is the mean severity in each 7-day period.|Open Label Phase (Screening plus two weeks)|84 patients were analyzed at the screening timepoint, 84 patients were analyzed at week 1 and 79 patients were analyzed at Week 2 due to discontinuations.||Units on a scale||Standard Deviation|Mean
140563|NCT00464646|Secondary|Recurrence-free Survival||From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry||||||
139999|NCT00468559|Secondary|Improvement in Physician's Global Assessment (PGA) Following Open-label Esomeprazole (Open-label Phase Endpoint)|Number of patients who had an improvement of at least one category in the PGA at the end of open-label treatment with esomeprazole compared to baseline. Improvement in PGA was a pre-requisite for randomization into the randomized treatment withdrawal phase. Only patients with PGA at baseline and end of open-label are analyzed here.|Open-label treatment period (2 weeks)|95 patients received open-label esomeprazole during the open-label phase.||Participants|||Number
140000|NCT00468559|Secondary|Severity of Feeding Difficulties Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
140001|NCT00468559|Secondary|Severity of Supraesophageal/Respiratory Disturbances (Coughing/Wheezing,Labored Breathing) as Reported by Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
140002|NCT00468559|Secondary|Severity of Irritability Crying/Fussing Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
140003|NCT00468559|Secondary|Severity of Vomiting/Regurgitation Symptoms as Reported by the Parent/Guardian (Treatment Withdrawal Phase Endpoint)|Change from baseline in symptom severity (Severity is scored as 0-4 [none, mild moderate, severe]). For each participant, final severity score is the mean severity in the final 7-days, while baseline is the mean severity in the 7-day period up to and including randomization. Changes less than zero indicate improved severity versus baseline. Participants needed baseline measure and one additional post baseline measure to be included in analysis.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study) Change was calculated from baseline to last measure obtained|||Units on a scale||Standard Deviation|Mean
140004|NCT00468559|Secondary|Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)|Percentage of participants with Physician's Global Assessment (PGA) score at the final treatment withdrawal assessment in following categories: None (no symptoms), Mild, Moderate or Severe. The worst post-randomization Physician's Global Assessment (PGA) assessment during double blind phase is taken into account.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|||Percentage of participants|||Number
140005|NCT00468559|Secondary|Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).|"The number of participants reaching the end of the treatment withdrawal phase without discontinuing from the study (for any reason) or showing symptom worsening in the physician global assessment of Gastroesophageal Reflux Disease (GERD) symptoms. Based on the severity of symptoms reported by the parent/guardian in IVRS, the investigator provided the overall clinical impression of the patient’s GERD-related symptoms over the last 7 days as:~None Mild Moderate Severe"|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|||Participants|||Number
140006|NCT00468559|Secondary|Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing due to any reason was identical to the number of participants discontinuing due to symptom worsening (the primary assessment) when no participants discontinued due to reason other than symptom worsening.|Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|Reporting cumulative discontinuations. Results for the analysis of the secondary variable, time to discontinuation due to any cause, were identical to that found for the primary variable, time to discontinuation due to symptom.||Participants|||Number
140007|NCT00468559|Primary|Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)|Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.|Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)|reporting cumulative discontinuations||Participants|||Number
140008|NCT00468546|Secondary|Percentage of Participants Without Erosive Progression|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage and negative change score indicates improvement.|Up to Week 104|ITT population included all randomized participants who received any part of an infusion of study medication. Participants with available data at the time of evaluation were analyzed.||percentage of participants|||Number
140114|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||log CFU/mL||Standard Deviation|Mean
140009|NCT00468546|Secondary|Mean Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score, Genant-modified Sharp Total Score, and Erosion Score|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290. For all the three radiograph assessment, the minimum score is 0. A higher score indicates more damage and a negative change score indicates improvement. The change in score is to be calculated as: Change from Baseline = difference between the score at Weeks 24, 56, or 104 and the score at Baseline.|From Baseline (Day 1) to Weeks (W) 24, 56, and 104|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||units on a scale||Standard Deviation|Mean
140010|NCT00468546|Secondary|Number of Participants With Change From Baseline in the Mental Component Scores of SF-36|The SF-36 determined participants’ overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on mental component were summed and averaged (range = 0 [worst]-100 [best]); increase from baseline indicated improvement. If participants’ had shown change from baseline in mental health score >6.33, it was considered as improved; scores between -6.33 to 6.33 was considered unchanged, and score <-6.33 was considered as worsened. Change from Baseline = difference between the mental component score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.||participants|||Number
140011|NCT00468546|Secondary|Number of Participants With Categorical Change From Baseline in the Physical Component Scores of SF-36|The SF-36 determined participants’ overall quality of life by assessing :1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Scores on physical component were summed and averaged (range 0 [worst] to 100 [best]); If participants’ had shown change from baseline in physical health component score >5.42, it was considered as improved; score between -5.42 to 5.42 was considered as unchanged, and score < -5.42 was considered as worsened. Change from Baseline = difference between the score of physical component at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.||participants|||Number
140012|NCT00468546|Secondary|Mean Change From Baseline of Short Form 36 Total Scores at Week 24|The Short Form (SF)-36 determined participants’ overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual daily activities because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems since last month; 7) limitations in usual work (house hold and outside) due to emotional problems 8) current and 1 year past status of health 9) general mental health. Transforming and standardizing these domains leads to the calculation of the physical component summary and mental component summary measures. Scores on each item were summed and averaged (range 0 [worst] to 100 [best]); increase in score from baseline indicated improvement. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants with available data at the time of evaluation were analyzed.||units on a scale||Standard Deviation|Mean
140013|NCT00468546|Secondary|Percentage Change From Baseline in the ACR Core Set (SJC, TJC, Patient’s and Physician’s Global Assessments, Health Assessment Questionnaire, Pain, C-Reactive Protein, and Erythrocyte Sedimentation Rate) Score|Percentage change in the scores of the following parameters of ACR core set relative to respective baseline scores in both study arms was analyzed : SJC (28 and 66 joints) and TJC (28 and 66 joints), patient’s global assessment and physician’s global assessment based on disease activity (both are expressed by VAS [0 = no disease activity to 100 = maximum disease activity]), HAQ (based on HAQ disability index [HAQDI]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain), CRP concentration, and ESR.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||percent change||Standard Deviation|Mean
140014|NCT00468546|Secondary|Number of Participants With Good, Moderate, or no European League Against Rheumatism Responses at Week 24|European League Against Rheumatism (EULAR) response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. At a given visit, participants with a DAS28 score of < 3.2 are considered good responders if the change from baseline in their DAS28 score is >1.2. Participants with a DAS28 score >= 3.2 to 5.1 are considered moderate responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6. Participants with DAS28 score >5.1 are considered non-responders if the change from baseline in their DAS28 score is <=1.2 to >=0.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
140015|NCT00468546|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission at Week 24|The DAS28 is an evaluation index of RA. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC- 28 joints, 2. SJC- 28 joints, 3. ESR or CRP measurement, 4. Participant’s judgement on his own overall health status (GH) expressed by a visual analogue scale VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10. A participant was categorized as having low disease activity, if participant’s DAS28 score was <= 3.2, and was categorized as having clinical remission if participant’s DAS28 score was < 2.6.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||percentage of participants|||Number
140016|NCT00468546|Secondary|Mean Change From Baseline in Disease Activity Score of 28 Joints at Week 24|The disease activity score (DAS28) is an evaluation index of rheumatoid arthritis. The DAS28 applies a mathematical formula based on the following parameters: 1. TJC-28 joints, 2. SJC -28 joints, 3. ESR or CRP measurement, 4. Participant’s judgement on his own overall health (global health [GH]) status expressed by a VAS (0 [no disease activity] to 100 [maximum disease activity]). The mathematical formula is 0.56 × √28TJC + 0.28 × √28SJC + 0.7 x loge ESR + 0.014 × GH. The DAS28 scale ranges from score of 0 to 10, where lower scores indicate best disease control and higher scores indicate worsening of disease. Change from Baseline = difference between the score at Week 24 and the score at Baseline.|From Baseline (Day 1) to Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||units on a scale||Standard Deviation|Mean
140017|NCT00468546|Secondary|Number of Participants With ACR 70 Response at Week 24|ACR 70 response is defined as a >= 70% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
140018|NCT00468546|Secondary|Number of Participants With an ACR 50 Response at Week 24|ACR 50 response is defined as a >= 50% improvement (reduction) in score compared with baseline for both TJC -68 joints and SJC -66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a VAS ranging from score '0'=no pain to score '100'=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging from score '0'=no disease activity to score '100'=maximum disease activity; HAQ : Health Assessment Questionnaire (HAQ):which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either CRP or ESR.|Week 24|The ITT population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
140019|NCT00468546|Primary|Number of Participants With American College of Rheumatology 20 Response at Week 24|American College of Rheumatology (ACR) 20 response is defined as >= 20% improvement (reduction) in score compared with baseline for both tender joint count (TJC)-68 joints and swollen joint count (SJC)-66 joints, as well as for 3 of the additional 5 ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) ranging from score 0 (no pain) to 100 (unbearable pain); Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS ranging score 0 (no disease activity) to 100 (maximum disease activity); Health Assessment Questionnaire (HAQ):8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do) for a total possible score of 0 (best) to 3 (worst); and acute-phase reactant, either C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|Intent to treat (ITT) population included all randomized participants who received any part of an infusion of study drug. Participants whom treatment allocation was unblinded and who received treatment prior to randomization were excluded.||participants|||Number
140020|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140021|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140022|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140023|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140024|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140025|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140026|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140027|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140028|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140029|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140030|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140031|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140032|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140033|NCT00468481|Post-Hoc|Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140034|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140035|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140036|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140115|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-CABG - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site after surgery minus before surgery (prior to skin prep).|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||log CFU/mL||Standard Deviation|Mean
140037|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140038|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140039|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140040|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140041|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140042|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140043|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140044|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140045|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140046|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140047|NCT00468481|Post-Hoc|Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|at baseline (week 0)|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140048|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 24|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
140049|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 20|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
140050|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 16|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
149728|NCT00390780|Secondary|Treatment Compliance|Number of patients who were 100% compliant with the treatment regimen|Initiation of treatment to Day 14|ITT (all randomized patients who took at least 1 dose of study medication)||participants compliant|||Number
140051|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 12|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
140052|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 8|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||µg/L||Standard Deviation|Mean
140053|NCT00468481|Secondary|Mean Change From Baseline in Plasma Homocysteine Levels at Week 4|Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||µg/L||Standard Deviation|Mean
140054|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 20|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140055|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 16|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140056|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 12|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140057|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 8|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||µg/L||Standard Deviation|Mean
140058|NCT00468481|Secondary|Mean Change From Baseline in Plasma Folate Levels at Week 4|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140059|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 20|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140060|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 16|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140061|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 12|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140062|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 8|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||Standard Deviation|Mean
140063|NCT00468481|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4|RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit|baseline and up to week 4|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24||nmol/L||Standard Deviation|Mean
140064|NCT00468481|Secondary|Mean Neural Tube Defect (NTD) Risk Reduction at Week 24|The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline|Baseline and week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||per 1000 birth||Standard Deviation|Mean
140065|NCT00468481|Primary|Plasma Folate Level at 24 Weeks|Folate concentrations in plasma were determined by an appropriately validated microbiological assay.|Week 24|Analysis was based on Per Protocol Set (PPS) defined as all subjects who had no major protocol deviations and completed 24 weeks of treatment with valid data for one of the co-primary efficacy variables at baseline and week 24.||nmol/L||95% Confidence Interval|Least Squares Mean
140067|NCT00468143|Secondary|Self Report|Self-reported adherence was ascertained via retrospective self-report of daily regimen adherence. Participants were considered adherent for Adderall IR (Methamphetamine salts) if they took the first does in the morning within 30 minutes of waking, and then each subsequent dose in 5-hour intervals (within 30 minutes). For Adderall XR (Methamphetamine salts), participants were considered adherent if they took the single daily dose in the morning within 30 minutes of waking. The number given below represents the total number of self-reported adherent participants divided by the total number of participants per group, times 100 (to obtain percentage).|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of participants adherent|||Number
140068|NCT00468143|Secondary|Pill Count|Study staff counted unused medication at each weekly visit to yield a percentage of prescribed pills that were consumed. For each group, the number given will be the total number of consumed pills divided by total number of pill prescribed.|At clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of pills consumed|||Number
140069|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Time Adherence|Time adherence (MEMSt) is the percentage of doses taken as prescribed within a specified time period. Adherence was measured as ≥ 80% of doses taken at the correct time. The number below is the percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of participants adherent|||Number
140070|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Regimen Adherence|Regimen adherence (MEMSr) is a percentage of the number of days in which the complete dose regimen was taken as prescribed. Adherence was measured as complete dose regimen taken on ≥ 90% of days. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|||percentage of participants adherent|||Number
140071|NCT00468143|Primary|Medication Event Monitoring System (MEMS®) Dosage Adherence|Dosage adherence (MEMSd) is the number of bottle openings divided by number of doses prescribed. Adherence was measured as ≥ 75% of the doses. The number below is the total percentage of subjects who were adherent.|The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)|These is the total of participants who completed the study.||percentage of participants adherent|||Number
140072|NCT00468104|Secondary|Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy|patients were followed for 6 weeks and resolution of sepsis was documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
140073|NCT00468104|Secondary|Number of Participants With Shortness of Breath That Responded to Therapy|patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
140074|NCT00468104|Secondary|Number of Participants With Pleural Effusion/Empyema That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
140075|NCT00468104|Secondary|Number of Participants With Pneumonia That Responded to Therapy|patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia|6 weeks|protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed||participants|||Number
140076|NCT00468104|Primary|No Surgical Intervention|CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.|patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months|intention to treat||participants|||Number
140077|NCT00468052|Secondary|Participants Requiring Morphine Rescue in PACU||arrival in PACU to 2 hours postoperatively|||participants|||Number
140078|NCT00468052|Secondary|Number of Participants With SpO2 < or Equal to 95%||on arrival to PACU and 2 hours postoperatively|||participants|||Number
140079|NCT00468052|Secondary|Time to Extubation|defined as time from end of surgery to tracheal extubation|at end of surgical procedure|per protocol||minutes||Standard Deviation|Mean
140080|NCT00468052|Secondary|Time to Awaken|defined as spontaneous eye opening or on command|at end of surgery|per protocol||minutes||Standard Deviation|Mean
140081|NCT00468052|Secondary|Hemodynamic Stability|Participants whose heart rate per minute was below 60 intraoperatively. Participants whose systolic blood pressure dremonstrated < 30% decrease from baseline and sustained for 5 minutes received rescue as defined by the protocol.|intraoperatively|||participants|||Number
140082|NCT00468052|Primary|Duration of Agitation|Cole EA scale 1=calm , 5=unconsolable|on arrival to PACU and for 2 hours postoperatively|||minutes||Standard Deviation|Mean
140083|NCT00468052|Primary|Emergence Agitation and Pain|"emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated .~Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain"|On arrival to PACU and 2 hours postoperatively|per protocol, OPS, PAED and Cole scale are expressed as median values of the maximum score||units on a scale||Full Range|Median
140084|NCT00467961|Secondary|Secondary Objectives Include Determining the Rate od Standard Transplant Outcome Variables: Toxicity, Relapse, Graft Rejection, Disease Free Survival.||3 years maximum||||||
140097|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of complete doses||Standard Deviation|Mean
140085|NCT00467961|Primary|To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression.|Patients will receive a selectively photodepleted lymphocyte product which will be delivered together with the T cell depleted stem cell product on the day of transplantation. Subjects will receive a conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34-selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized. To determine if selective T cell depletion using the photodepletion procedure can substantially reduce the number of severe acute GVHD (grade III/IV) after transplantation followed by low-dose or no immunosuppression.|Day 90|The study accrued 31 transplant recipents and 30 donors. Of the 31 transplant recipients, there were 24 evaluable recipients. Seven of the 24 recipients did not receive transplantation.||participants|||Number
140086|NCT00467896|Primary|Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)|Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of full doses administered||Standard Deviation|Mean
140087|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)|HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population||beats per minute||Standard Deviation|Mean
140088|NCT00467896|Secondary|Heart Rate (HR) - Iloprost PD-6 (Period I)|HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population||beats per minute||Standard Deviation|Mean
140089|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
140090|NCT00467896|Secondary|Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)|DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
140091|NCT00467896|Secondary|Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)|SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15|Day 1 and Day 7, following the first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
140092|NCT00467896|Secondary|Systolic Blood Pressure - Iloprost PD-6 (Period I)|SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6|Day 1, prior to first dose of iloprost PD-15|safety population||mmHg||Standard Deviation|Mean
140093|NCT00467896|Secondary|Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of daily doses||Standard Deviation|Mean
140094|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-15 (Period II)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of full doses administered||Standard Deviation|Mean
140095|NCT00467896|Secondary|Percentage of Daily Doses Within the 6–9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)|The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of daily doses||Standard Deviation|Mean
140096|NCT00467896|Secondary|Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)|The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of complete doses||Standard Deviation|Mean
149818|NCT00389493|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form|QLESQ ranges from 14-70, with higher scores meaning more enjoyment and satisfaction with quality of life|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
140098|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-15 (Period II)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||minutes||Standard Deviation|Mean
140099|NCT00467896|Secondary|Daily Inhalation Duration - Iloprost PD-6 (Period I)|Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||minutes||Standard Deviation|Mean
140100|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-15 (Period II)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days following first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||inhalations/day||Standard Deviation|Mean
140101|NCT00467896|Secondary|Number of Daily Inhalations - Iloprost PD-6 (Period I)|Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||inhalations/day||Standard Deviation|Mean
140102|NCT00467896|Primary|Inhalation-times Rate - Iloprost PD-6 (Period I)|Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full)|37 days prior to first dose of iloprost PD-15|Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15.||percentage of full doses administered||Standard Deviation|Mean
140103|NCT00467857|Secondary|Number of Patients With Alcohol Use, Tobacco Use, or Obesity With Surgical Site Infection (SSI)|Number of patients with risk factors of alcohol use, tobacco use, or obesity who developed an SSI at the sternal and/or graft site|30 days|Subset of Intention to treat participants with alcohol use, tobacco use, or obesity||Participants|||Number
140104|NCT00467857|Secondary|Number of Patients With SSI at the Sternal Site and/or Graft Site|Number of patients who develop at least one surgical site infection at the sternal or graft site during the 30 day post-op follow-up period|30 days|Intention to treat||Participants|||Number
140105|NCT00467857|Secondary|Post-incision Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol||log CFU/mL||Standard Deviation|Mean
140106|NCT00467857|Secondary|Post-incision Bacterial Count - Sternal Site|Total bacterial counts from samples of skin flora of the sternal incision site taken immediately following the surgical incision|Immediately after surgical incision|Per protocol||log CFU/mL||Standard Deviation|Mean
140107|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Graft Site|Total bacterial counts from samples of skin flora from the graft incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||log CFU/mL||Standard Deviation|Mean
140108|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the graft incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||isolates||Standard Deviation|Mean
140109|NCT00467857|Secondary|Change in Bacterial Count From Pre-skin Preparation to Post-incision - Sternal Site|Total bacterial counts from samples of skin flora from the sternal incision site immediately after incision minus before surgery (prior to skin prep)|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||log CFU/mL||Standard Deviation|Mean
140110|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Graft Site|Number of unique bacterial colony types isolated from samples of skin flora from the graft incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||isolates||Standard Deviation|Mean
140111|NCT00467857|Secondary|Change in the Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-incision - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora from the sternal incision site immediately after the incision minus before surgery (prior to surgical skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and immediately after incision|Per protocol||isolates||Standard Deviation|Mean
140112|NCT00467857|Secondary|Post-CABG Procedure Bacterial Count - Graft Site|Total bacterial counts from samples of skin flora of the graft incision site taken immediately following the CABG procedure.|Post-surgery|Per protocol||log CFU/mL||Standard Deviation|Mean
140116|NCT00467857|Primary|Change in Number of Unique Bacterial Isolates From Pre-skin Preparation to Post-CABG - Sternal Site|Number of unique bacterial colony types isolated from samples of skin flora taken from the sternal incision site after surgery minus before surgery (prior to skin prep). Unique colonies were determined based on Gram stain, colony morphology, catalase, coagulase, or staphylococci latex agglutination and oxidase tests.|Before surgery (prior to skin preparation) and after surgery (after closing fascia)|Per protocol||isolates||Standard Deviation|Mean
140117|NCT00467844|Secondary|To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.|Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=[9.8 m/sec**2]*[weight (kg)]*[height of 12 steps(meters)]/ [time (seconds) up the 12 steps].|Four Months|The subjects were in the MITT population (had a post baseline DEXA) and had a month 4 stair climb assessment (observed cases).||watts||Full Range|Median
140118|NCT00467844|Primary|The Efficacy of GTx-024 on Total Body Lean Mass.|Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.|Baseline to Four Months|The number of participants were those subjects in the modified intent-to-treat population (defined as subjects with at least one post baseline DEXA for LBM) who had baseline and 4 month DEXA results for LBM (observed cases).||kg||Full Range|Median
140119|NCT00467831|Primary|Survival at 2 Years|The number of subjects surviving after 24 months on study.|24 months|||participants|||Number
140120|NCT00467779|Secondary|Stage III: AUC0-inf of Midazolam|AUC0-inf is the AUC from time 0 to infinity and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
140121|NCT00467779|Secondary|Stage III: AUC0-24 of Midazolam|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was calculated both in the presence (Cycle 1 Day 15) and absence (CXycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
140122|NCT00467779|Secondary|Stage III: Cmax of Midazolam|Cmax is the maximum observed plasma concentration and was calculated both in the presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Geometric Mean
140123|NCT00467779|Secondary|Stage III: AUC 0-inf of Dextromethorphan|AUC0-inf is AUC from time 0 to infinity and was calculated both in presence Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
140124|NCT00467779|Secondary|Stage III: AUC 0-24 of Dextromethorphan|AUC0-24 is the area under the plasma drug concentration curve over a 24-hour sampling interval and was determined both in presence (Cycle 1 Day 15) and absence (Cycle 1 Day 1) of cobimetinib.|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n = number of participants analyzed for specified category. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
140125|NCT00467779|Secondary|Stage III: Cmax of Dextromethorphan|Cmax is defined as maximum observed plasma concentration and was determined both in the presence (Cycle 1 Day 15) and absence of cobimetinib (Cycle 1 Day 1).|Stage III: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, and 24 hours after dextromethorphan administration on Days 1 and 15 of Cycle 1|Safety population; Stage 3 participants only. n=number of participants analyzed for specified category.||ng/mL||Standard Deviation|Geometric Mean
140126|NCT00467779|Secondary|Stage 2A: Cmax of Cobimetinib at Steady State|Cmax is the maximum plasma concentration achieved following the Day 20 dose in Stage 2A.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Analysis population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Geometric Mean
140127|NCT00467779|Secondary|Stage 2A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2A in steady state.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140128|NCT00467779|Secondary|Stage 2A: Half-Life of Cobimetinib at Steady State||Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140129|NCT00467779|Secondary|Stage 2A: Apparent Clearance of Cobimetinib at Steady State|Apparent clearance is the plasma clearance of absorbed drug.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||L/hr||Standard Deviation|Mean
140130|NCT00467779|Secondary|Stage 2A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio AUC0-24 is ratio of AUC on Day 20: Day 1.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Mean
140131|NCT00467779|Secondary|Stage 2A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15), and between Cycle 1 Days 26-28|Safety population; Stage 2A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
140132|NCT00467779|Secondary|Stage 2:Half-Life of Cobimetinib at Steady State|T1/2 half-life of cobimetinib measured over the terminal phase by noncompartmental analysis.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140133|NCT00467779|Secondary|Stage 2: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population||L/hr||Standard Deviation|Mean
140134|NCT00467779|Secondary|Stage 2: Accumulation Ratio of Cobimetinib at Steady State|Accumulation ratio is AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Geometric Mean
140135|NCT00467779|Secondary|Stage 2: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
140136|NCT00467779|Secondary|Stage 2: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
140137|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 2 in steady state.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 21, 24 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22), and between Cycle 1 Days 26-28|Safety population; Stage 2 participants only; Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140138|NCT00467779|Secondary|Stage 2: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 2 on Day 1.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140139|NCT00467779|Secondary|Stage 2:AUC 0-24 of Cobimetinib at Cycle 1 Day 1|The area under the AUC0-24 on Day 1 in stage 2 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Geometric Mean
140140|NCT00467779|Secondary|Stage 2: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 2 and was measured in ng/mL.|Stage 2: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 2 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Geometric Mean
140141|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1A and was measured in steady state as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Mean
140142|NCT00467779|Secondary|Stage 1A: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng*hr/mL/mg||Standard Deviation|Mean
140143|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1A was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
140144|NCT00467779|Secondary|Stage 1A: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Mean
140145|NCT00467779|Secondary|Stage 1A: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number pf participants analyzed = participants who were evaluable for this outcome.||L/hr||Standard Deviation|Mean
140146|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140147|NCT00467779|Secondary|Stage 1A: t1/2 of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1A in steady state.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 14, 24, 48, 72 hours post Cycle 1 Day 14 dose (Cycle 1 Day 15, 16, and 17, respectively)|Safety population; Stage 1A participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140148|NCT00467779|Secondary|Stage 1A: AUC 0-24 of Cobimetinib at Cycle 1 Day 1|AUC0-24 for stage 1A was calculated on Day 1 with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.||h*ng/mL||Standard Deviation|Mean
140149|NCT00467779|Secondary|Stage 1A: Cmax of Cobimetinib at Cycle 1 Day 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on on Day 1 in Stage 1A and was measured as ng/mL.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.||ng/mL||Standard Deviation|Mean
140150|NCT00467779|Secondary|Stage 1A: Tmax of Cobimetinib at Cycle 1 Day 1|Tmax is defined as the time to reach Cmax during stage 1A at Day 1.|Stage 1A: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1A participants only.||hours||Full Range|Median
140151|NCT00467779|Secondary|Stage 1: Cmax of Cobimetinib at Steady State|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib in Stage 1 and was measured at steady state in ng/mL.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng/mL||Standard Deviation|Mean
140152|NCT00467779|Secondary|Stage 1: Half-Life (t1/2) of Cobimetinib at Steady State|t1/2 is the half-life of cobimetinib measured over the terminal phase by noncompartmental analysis in stage 1 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140153|NCT00467779|Secondary|Stage 1: Apparent Clearance of Cobimetinib at Steady State|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent clearance was calculated only for participants who had a quantifiable AUC 0-24 in steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||Liters per hour (L/hr)||Standard Deviation|Mean
140154|NCT00467779|Secondary|Stage 1: Accumulation Ratio of Cobimetinib at Steady State|Accumulation Ratio: AUC0-24 at steady state divided by AUC0-24 on Cycle 1 Day 1. It was calculated only for participants who had a quantifiable AUC 0-24 at steady state.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ratio||Standard Deviation|Mean
140155|NCT00467779|Secondary|Stage 1: AUC 0-24/D of Cobimetinib at Steady State|AUC 0-24/D is the dose normalized truncated AUC over a 24-hour sampling interval.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety Population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||ng*hr/mL/mg||Standard Deviation|Mean
140156|NCT00467779|Secondary|Stage 1: AUC 0-24 of Cobimetinib at Steady State|The area under the AUC0-24 for steady state in stage 1 was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samplings.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||h*ng/mL||Standard Deviation|Mean
140157|NCT00467779|Secondary|Stage 1: Tmax of Cobimetinib at Steady State|Tmax is defined as the time to reach Cmax during stage 1 in steady state. Steady state was reached when overall intake of cobimetinib was in dynamic equilibrium with its elimination.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 21, 24, 48, and 72 hours post Cycle 1 Day 21 dose (Cycle 1 Day 22, 23, and 24, respectively)|Safety population; Stage 1 participants only. Number of participants analyzed = participants who were evaluable for this outcome.||hours||Full Range|Median
140158|NCT00467779|Primary|Stage 1: Time to Maximum Concentration (Tmax) of Cobimetinib at Day 1, Cycle 1|Tmax is defined as the time to reach Cmax during stage 1 at Day 1 Cycle 1.|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.||hours||Full Range|Median
140159|NCT00467779|Primary|Stage 1: Area Under the Plasma Cobimetinib Concentration Curve From Time 0 to 24 Hours (AUC 0-24) Day 1, Cycle 1|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration of cobimetinib up to 24 h after administration by the trapezoidal formula. AUC 0-24 is the truncated AUC over a 24-hour sampling interval. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free cobimetinib in the blood samples. AUC is measured as hours times nanograms per milliliter (h*ng/mL).|Stage 1: Pre-dose & 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1, pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.||h*ng/mL||Standard Deviation|Geometric Mean
140160|NCT00467779|Primary|Stage 1: Maximum Observed Concentration (Cmax) of Cobimetinib at Day 1, Cycle 1|Cmax is defined as the maximum plasma concentration achieved after administration of cobimetinib on Day 1, Cycle 1 in Stage 1 and was measured as nanograms per milliliter (ng/mL).|Stage 1: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12-18 hours post-dose on Cycle 1 Day 1 and pre-dose on Cycle 1 Day 2|Safety population; Stage 1 participants only.||ng/mL||Standard Deviation|Geometric Mean
140161|NCT00467779|Primary|Stage 1A: MTD of Cobimetinib in 14/14 Schedule|"AEs were graded according to NCI-CTCAE v3.0. A DLT was the basis for determining MTD in Stage 1A participants. The participants of Stage 1A are dose-escalation cohorts, starting at the MTD of the 21/7 schedule, were treated on a 14/14 schedule to determine the MTD. A DLT was defined as either of the following occurring during the Study Treatment Period:~Occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants to risk of irreversible medical harm; Nonhematologic toxicity: Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment; Hematologic toxicity: Grade 4 thrombocytopenia. Grade 4 neutropenia of more than 4 days’ duration; Grade 4 neutropenia of any duration with fever or documented infection. AEs (Grade 3 or higher) for which a clinical cause unrelated to cobimetinib was evident was not considered DLTs."|Stage 1A: Days 1 to 28 of Cycle 1|Safety population; Stage 1A participants only.||mg|||Number
140162|NCT00467779|Primary|Stage 1: Maximum Tolerated Dose (MTD) of Cobimetinib in 21/7 Schedule|"AEs were graded according to the NCI-CTCAE v3.0. A DLT was determined from clinical findings during the Study Treatment Period (Cycle 1, Days 1). MTD was defined as the dose at which no DLTs were observed. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the CRC, was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity~Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity~Grade 4 thrombocytopenia~Grade 4 neutropenia of greater than or equal to (≥) 4 days’ duration~Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1: Days 1 to 28 of Cycle 1|Safety population; Stage 1 participants only.||milligrams (mg)|||Number
140163|NCT00467779|Primary|Stage 1 and 1A: Number of Participants With Dose Limiting Toxicities (DLTs)|"Adverse events (AE) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0. DLT was defined as either of the following occurring during the Study Treatment Period. The occurrence of a drug-related AE that, in the opinion of the cohort review committee (CRC), was of potential clinical significance such that further dose escalation would expose participants in higher dose cohorts to risk of irreversible medical harm or require medical treatment to avoid irreversible medical harm or non-hematologic toxicity~Grade 3 or 4 events, including Grade 3 nausea and/or vomiting and/or Grade 3 diarrhea, despite prophylaxis and/or treatment Hematologic toxicity~Grade 4 thrombocytopenia~Grade 4 neutropenia of greater than or equal to (≥) 4 days’ duration~Grade 4 neutropenia of any duration with fever or documented infection"|Stage 1 and 1A: Days 1 to 28 of Cycle 1|Safety population; Stages 1 and 1A participants only.||participants|||Number
140164|NCT00467753|Primary|Autism Diagnostic Observation Schedule||Evaluated during Baseline and Termination||||||
140165|NCT00467753|Primary|Clinical Global Impression Improvement Scale||Once a week||||||
140166|NCT00467753|Primary|Aberrant Behavior Checklist||Bi weekly||||||
140167|NCT00467753|Primary|Vineland Adaptive Behavior Scales||Evaluated during Baseline and Termination||||||
140168|NCT00467740|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and 29 days|Treated Set||mmol/L||Inter-Quartile Range|Geometric Mean
140169|NCT00467740|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set||participants|||Number
140170|NCT00467740|Secondary|Total Score in Asthma Control Questionnaire After 4 Weeks|Adequacy of asthma control was assessed using a scale of: 0=totally controlled, to 6=Severely uncontrolled.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||units on a scale||Standard Error|Least Squares Mean
140205|NCT00467649|Secondary|Phase 2: Change in Body Weight at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat||kg||Standard Error|Mean
140171|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||hours||Full Range|Median
140172|NCT00467740|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
140173|NCT00467740|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=24 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
140174|NCT00467740|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=6 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
140175|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3 at steady state.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h), 3h and 6h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
140176|NCT00467740|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||hours||Full Range|Median
140177|NCT00467740|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma.|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
140178|NCT00467740|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma from 0 to time t=3|30 minutes (mins) before drug administration and 5mins, 10mins, 20mins, 40mins, 1 hour (h) and 3h after drug administration|All evaluable patients were included in the pharmacokinetic (PK) analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
140179|NCT00467740|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (prn salbutamol [albuterol]) as assessed by the e-Diary (e-Diary incorporated in AM2+).|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Number of Puffs||Standard Error|Least Squares Mean
140180|NCT00467740|Secondary|PEFR Variability After 4 Weeks|PEFR variability represents the absolute difference between the highest morning PEFR value and the highest evening PEFR value of 1 day, divided by the arithmetic mean of these 2 PEFR values and expressed as a percent, weekly means.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||percentage of PEFR||Standard Error|Least Squares Mean
140181|NCT00467740|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Response was defined as change from baseline. Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
140182|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 6-12 h (AUC 6-12h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior to dose on first day of randomized treatment (baseline) and 1h, 3h, 6h, 9h, 12h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140183|NCT00467740|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140184|NCT00467740|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140185|NCT00467740|Secondary|Peak FVC (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140186|NCT00467740|Secondary|Peak FVC (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140187|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140188|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140189|NCT00467740|Secondary|Peak FEV1 (0-3h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140190|NCT00467740|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140191|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140192|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140193|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140194|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140195|NCT00467740|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140196|NCT00467740|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140197|NCT00467740|Secondary|Trough FVC Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140198|NCT00467740|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140199|NCT00467740|Secondary|Trough FVC Response After 1 Week|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140200|NCT00467740|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140201|NCT00467740|Secondary|Trough FEV1 Response After 1 Week|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140202|NCT00467740|Secondary|Weekly Mean Pre-dose Morning PEFR After 4 Weeks|Response was defined as change from baseline. Baseline peak expiratory flow response (PEFR) was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
140203|NCT00467740|Primary|Trough FEV1 Response After 4 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
140204|NCT00467649|Other Pre-specified|Hypoglycemia Adverse Events|"MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating.~MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion).~SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention."|36 weeks|||participants|||Number
140250|NCT00467285|Secondary|Changes in CTx at Follow up|% change in the levels of CTx at 6 months follow up compared to baseline|6 months|||% change||Standard Deviation|Mean
140251|NCT00467285|Primary|Changes in BMD Total Hip|% change at 6 month follow up compared to baseline|6 months|||% change in BMD||Standard Deviation|Mean
140206|NCT00467649|Secondary|Phase 2: Change in HbA1c at Week 36|Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).|Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2 Intent-to-Treat||Percent||Standard Error|Mean
140207|NCT00467649|Secondary|Fasting Serum Lipids Change From Baseline to Week 24||Baseline, week 24|Phase 1 Intent-to-Treat||mg/dL||Standard Error|Mean
140208|NCT00467649|Secondary|Change in Fasting Plasma Glucose From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat||mg/dL||Standard Error|Mean
140209|NCT00467649|Secondary|Change in Waist Circumference From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||cm||Standard Error|Least Squares Mean
140210|NCT00467649|Secondary|Change in Body Weight From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||kg||Standard Error|Least Squares Mean
140211|NCT00467649|Secondary|Change in HbA1c From Baseline at Week 24|Baseline values are presented in the Baseline Characteristics section|From Baseline to Week 24|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||Percent||Standard Error|Least Squares Mean
140212|NCT00467649|Secondary|Percentage of Patients With a Severe Hypoglycemia Adverse Event|This is a component of the primary endpoint.|24 Weeks|Phase 1 Intent-to-Treat||Percent|||Number
140213|NCT00467649|Secondary|Percentage of Patients With no Weight Gain at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat||Percent|||Number
140214|NCT00467649|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 24|This is a component of the primary endpoint|24 Weeks|Phase 1 Intent-to-Treat||Percent|||Number
140215|NCT00467649|Primary|The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia|A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.|24 Weeks|Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.||Percent|||Number
140216|NCT00467610|Secondary|Hematological Improvement Rate at Week 8 as Defined by the IWG 2000 Criteria for Response Assessment, 2000 Version||At 8 weeks from start of therapy|||participants|||Number
140217|NCT00467610|Primary|Response Rate ( CR+PR) at Week 8, Based on the IWG Criteria for Response Assessment ( 2000 Version)|"Complete response(CR): <5% blasts in the bone marrow,with normal maturation of all cell lines, Hemoglobin >11 g/dL, neutrophils>1500/mm3 platelets>100,000/mm3.~Partial response (PR): >50% decrease in blasts, or less advanced IPSS than pretreatment value, same hematological parameters as in CR.~Stable disease (SD): No evidence of disease progression in bone marrow, stable peripheral blood counts failure: Increase in bone marrow blast percentage, progression to more advanced IPSS than pretreatment and worsening of cytopenias.~(Cheson, 2000)"|After 8 weeks of therapy with panhematin|||Participants|||Number
140218|NCT00467610|Secondary|Number of Patients Demonstrating Hematological Improvement to Panhematin® at Week 4.|"Hematological improvement (HI)~Major:~HI-Erythroid:>2 g/dL rise in hemoglobin, or transfusion independence HI-Neutrophil: Absolute increase of >500/mm3, or >100% increase HI-Platelet: Absolute increase of >30,000, or transfusion independence~Minor:~HI-Erythroid:1 to 2 g/dL increase in hemoglobin or 50% decrease in transfusion dependence.~HI-P: For patients with pretreatment platelet count < 100,000/mm3, ≥ 50% increase with a net increase > 10,000/mm3 but < 30,000/mm3.~HI-N: For patients with pretreatment ANC < 1500/mm3, ≥ 100% increase, but < 500/mm3 increase."|4 weeks after initiation of treatment with Panhematin|||participants|||Number
140219|NCT00467610|Primary|Safety and Tolerability of Panhematin®.|Number of patients with no adverse events.|participants were followed during therapy with panhematin, and up to six months post completion of therapy, average of 8 months.|||participants|||Number
140220|NCT00467597|Primary|Gaitmat Stance Measurements (AUC)|Gaitmat stance measurements were measured every half hour throughout an 8 hour period. Area under the curve was computed using the trapezoidal method for root mean squared velocity in the anterior-posterior direction. Each subject's unique baseline was used by computing the mean of the test-retest period measured at 08:00 am.|Every 1/2 hour during an 8 hour period.|||Root Mean Square of Velocity*Minutes||Standard Deviation|Mean
140221|NCT00467584|Primary|Modified Fatigue Impact Scale Score|The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always) were provided by the study subjects for the prior 4 week period. A total score was tallied from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.|Baseline, 8 weeks|62 patients were randomized; of these, 6 did not receive the intervention and an additional 4 discontinued without providing followup data. Therefore 52 were included in the analysis. The Wk 4 MFIS score was used if the subject withdrew prior to Wk 8. 1 subject each in the High Dose and Placebo groups provided MFIS data at Wk 4 but not Wk 8.||units on a scale||Standard Deviation|Mean
140222|NCT00467558|Primary|Yale Brown Obsessive Compulsive Scale Modified for Compulsive Sexual Behavior (YBOCS)|The YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity).|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
140252|NCT00467285|Secondary|Osteocalcin|% change at 6 month follow up compared to baseline|6 months|||% change||Standard Deviation|Mean
140223|NCT00467558|Secondary|Clinical Global Impression Scale - Severity|The CGI consists of two reliable and valid 7-item Likert scales used to assess severity in clinical symptoms. The scale ranges from 1 = “very much improved” to 7 = “very much worse.” The CGI severity scale was used at each visit and ranges from 1 = “not ill at all” to 7 = “among the most extremely ill.”|Assessed at each visit (every two weeks) until participation in the study was done (Week 8)|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
140224|NCT00467519|Primary|Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis|Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Pre-dose and 30 Days Post-vaccination|Geometric mean titers were assessed in the per-protocol population.||EU/mL||95% Confidence Interval|Geometric Mean
140225|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL.~Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.||Percentage of Participants|||Number
140226|NCT00467519|Other Pre-specified|Number of Participants Reporting at Least 1 Solicited Injection Site or Solicited Systemic Reaction Post-vaccination|Solicited Injection Site Reactions: Pain, erythema/redness, swelling, increased left limb circumference, and increased right limb circumference. Solicited Systemic Reactions: Fever (temperature), headache, malaise, and myalgia.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
140227|NCT00467519|Primary|Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis|"Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL~Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA)."|30 Days post-vaccination|Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.||Percentage of Participants|||Number
140228|NCT00467519|Primary|Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL|"Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL.~Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.||Percentage of Participants|||Number
140229|NCT00467519|Primary|Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level|"Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL.~Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA)."|Pre-dose and 30 days post-vaccination|Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.||Percentage of Participants|||Number
140230|NCT00467389|Secondary|Cocaine Pharmacokinetics|Area-Under-the-Curve for Plasma Concentration|0 to 8 hours|||ng-hr/ml||Standard Error|Mean
140231|NCT00467389|Secondary|Cocaine Subjective Effects|Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).|3 to 30 minutes|||mm||Standard Error|Mean
140232|NCT00467389|Primary|Cocaine Safety in Subjects Receiving Donepezil|Patients evaluated for clinical and laboratory adverse events|Two weeks|All participants included||Participants with an Adverse Event|||Number
140233|NCT00467363|Secondary|Abruption|Partial or complete abruption (ie, premature separation of the placenta)|until delivery|||participants|||Number
140234|NCT00467363|Secondary|Fetal Intolerance of Labor||until delivery|No data were collected for this Outcome Measure.|||||
140235|NCT00467363|Secondary|Abnormal Fetal Testing||8 weeks|No data were collected for this Outcome Measure.|||||
140236|NCT00467363|Secondary|Preterm Birth||until delivery|||infants|||Number
140237|NCT00467363|Secondary|Small for Gestational Age Infant|birthweight|until delivery|||grams||Standard Deviation|Mean
140238|NCT00467363|Secondary|Preeclampsia||until delivery|||participants|||Number
140239|NCT00467363|Secondary|Molar Pregnancy||8 weeks|||pregnancy|||Number
140240|NCT00467363|Secondary|Ectopic Pregnancy||within 6 weeks|||pregnancy|||Number
140241|NCT00467363|Secondary|Stillbirth||40 weeks|||participants|||Number
140242|NCT00467363|Secondary|Fetal Pregnancy Loss||until 40 weeks|||pregnancy|||Number
140243|NCT00467363|Secondary|Pregnancy Losses Occurring Less Than 10 Weeks|Includes preembryonic and embryonic losses (exclusive of implantation failures)|less than 10-weeks|||pregnancy|||Number
140244|NCT00467363|Secondary|Early Pregnancy Loss (EPL)|Implantation failures|8 weeks|||pregnancy|||Number
140245|NCT00467363|Secondary|Clinically Recognized Pregnancy||8-weeks|||pregnancy|||Number
140246|NCT00467363|Secondary|hCG Recognized Pregnancy||within 8-weeks of gestation|||pregnancy|||Number
140247|NCT00467363|Primary|Live Birth|Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .|after delivery|Analyses were based on the intention-to-treat principle (excluding participants lost to follow-up).||livebirths|||Number
140248|NCT00467285|Primary|Changes in BMD 0.33 Radius|% change in BMD at 6 month follow up compared to baseline|6 months|||% change in BMD||Standard Deviation|Mean
140249|NCT00467285|Primary|Changes in BMD AP Spine|% change in BMD at 6 month follow up compared to baseline|6 months|||% change in BMD||Standard Deviation|Mean
140254|NCT00467285|Primary|Changes in BMD at Femoral Neck|% changes in BMD ( BMD at Lumbar spine, femoral neck and 0.33 radius) and bone turn over markers in subjects with diabetes on pioglitazone compared to those who are not on Pioglitazone|6 months|28 subjects on pioglitazone and 64 subjects not on pioglitazone||percentage of change in BMD||Standard Deviation|Mean
140255|NCT00467259|Secondary|Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
140256|NCT00467259|Secondary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
140257|NCT00467259|Primary|Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1|Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies|52 weeks|Subjects with evaluable endometrial biopsies.||# Endometrial Hyperplasia/Evaluable Biop||95% Confidence Interval|Number
140258|NCT00467051|Secondary|Toxicity as Measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) Version 4.0|All patients who experience any grade 2 or higher toxicity at any time during the two treatment cycles or who receive at least all required Ifosfamide therapy after enrollment will be considered evaluable for toxicity. The descriptions and grading scales found in the revised NCI CTCAE version 4 will be used.|During and after completion of study treatment||||||
140259|NCT00467051|Primary|Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria.|At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)|||participants|||Number
140260|NCT00467038|Secondary|Group x Time Interaction Amygdala Activity|0 to 12 month difference scores in group x time interaction amygdala activity|Baseline and 12 months|||bold signal units||Standard Deviation|Mean
140261|NCT00467038|Primary|Self-Report of Difficulties in Emotion Regulation (DERS)|"The present study examines DBT treatment effect on emotion regulation in unmedicated outpatients with BPD as measured by changes in the Difficulties in Emotion Regulation Scale. The DERS is a brief, 36-item, self-report questionnaire.~DERS total score ranges from 36- 180. Higher scores reflect higher difficulties in emotion regulation.~The measure yields a total score as well as scores on six scales derived through factor analysis:~1. Nonacceptance of emotional responses, 2. Difficulties engaging in goal directed behavior, 3. Impulse control difficulties, 4. Lack of emotional awareness, 5. Limited access to emotion regulation strategies, 6. Lack of emotional clarity Responses are on a 5-point scale: 1=almost never, 2=sometimes, 3=about half the time, 4=most of the time, 5=almost always"|12 months|22 age- and gender-matched unmedicated BPD and HC participants (11 in each group).||units on a scale||Standard Deviation|Mean
140262|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset.|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140263|NCT00466947|Secondary|Number of Subjects With Anti-protein D (ANTI-PD) Antibody Concentrations >= 100 Enzyme-linked Immunosorbent Assay Units Per Milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140264|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||EL.U/mL||95% Confidence Interval|Geometric Mean
140265|NCT00466947|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset|ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||EL.U/mL||95% Confidence Interval|Geometric Mean
140266|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140267|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140268|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140269|NCT00466947|Secondary|Number of Subjects With Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140270|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6A and 19A in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
140271|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
140272|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
140273|NCT00466947|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset|The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination,|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Titers||95% Confidence Interval|Geometric Mean
140292|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|"The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum.~The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama."|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
140274|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140275|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140276|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140277|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 Microgram Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140278|NCT00466947|Secondary|Number of Subjects With Pneumococcal Antibody Concentrations Against Cross-reactive Serotypes 6A and 19A Higher >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140279|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140280|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
140281|NCT00466947|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Vaccine Serotypes >= 0.20 Micrograms Per Milliliter (µg/mL), in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||Subjects|||Number
150415|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
140282|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
140283|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)|Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
140284|NCT00466947|Secondary|Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset|Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
140285|NCT00466947|Secondary|Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.|Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|At Month 5, one month after the third dose of primary vaccination|Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available.||µg/mL||95% Confidence Interval|Geometric Mean
140286|NCT00466947|Secondary|Number of Subjects With Any Antibiotic Prescription at Least Once During the Entire Study Period, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
140287|NCT00466947|Secondary|Number of Subjects With Acquisition of New Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset.|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
140288|NCT00466947|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
140289|NCT00466947|Secondary|Number of Subjects With H. Influenzae Strains Identified in Nasopharyngeal Swabs, in the Carriage Subset|Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
140290|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Serotypes Identified in Nasopharyngeal Swabs Other Than the Synflorix Vaccine and Cross-reactive Serotypes, in the Carriage Subset|S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
140291|NCT00466947|Secondary|Number of Subjects With Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes Identified in Nasopharyngeal Swabs, in the Carriage Subset.|Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.|At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25|The analysis was performed on all vaccinated subjects included in the carriage subset.||Subjects|||Number
140293|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Disease (ID) Due to Haemophilus Influenzae|No subject was reported with any case of ID due to Haemophilus influenzae.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25||12/2050||||
149819|NCT00389493|Secondary|Social Adjustment Scale-SR|SAS-SR yields a mean score between 1 and 5; the higher the score, the more severe the social adjustment problems|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
140294|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Pneumococcal Serotypes Other Than Streptococcus (S. pn.) Vaccine and Cross-reactive Serotypes.|The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140295|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Invasive Pneumococcal Disease (IPD) Due to Streptococcus (S. pn.) Cross-reactive Pneumococcal Serotypes.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140296|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Pneumococcal Invasive Disease (Pneumococcal ID)|A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140297|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of a Bacteriologically Confirmed Invasive Pneumococcal Disease (Bact.-Conf. ID).|A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140298|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Vaccine-type Invasive Pneumococcal Disease (VT-IPD).|A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140299|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of CAP With Either Alveolar Consolidation/Pleural Effusion on Chest X-ray (CXR) (C-CAP) or With Non-alveolar Infiltrates (NAI-CAP) But With C Reactive Protein (CRP) >= Cut-off.|CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140300|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP) With C Reactive Protein (CRP) >= Cut-off, Regardless of Chest X-ray (CXR) Reading|A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140301|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal Chest X-ray (CXR)|An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140302|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Suspected Community Acquired Pneumoniae (CAP) (S-CAP)|An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140303|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT).||Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140304|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Any Abnormal CXR With Positive Respiratory Viral Test (RVT)|An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140305|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP) With Positive Respiratory Viral Test (RVT)|A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140306|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other AOM Pathogens, in the Panama Subset|Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140307|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Non-typeable Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140308|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Haemophilus Influenzae (H. Influenzae), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140309|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Other Pneumococcal Serotypes, in the Panama Subset.|Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140358|NCT00466505|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death.|On study date to off study date in this study with median 9.76 months|||patients|||Number
140310|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Cross-reactive Serotypes, in the Panama Subset.|The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140311|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Streptococcus Pneumoniae (S. pn.) Vaccine Serotypes, in the Panama Subset|The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140312|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Bacteriologically Confirmed Acute Otitis Media (AOM) (B-AOM) Due to Any Bacterial Pathogen, in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140313|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Community Acquired Pneumoniae (CAP) With Alveolar Consolidation or Pleural Effusion on the Chest X-ray (CXR) (C-CAP)|CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.|Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140314|NCT00466947|Secondary|Number of Subjects With a First Episode Reported of Clinically Confirmed Acute Otitis Media (AOM) (C-AOM), in the Panama Subset|The Panama Subset contained all subjects enrolled in Panama.|Any time from 2 weeks after Dose 3 to study end at Month 22-25|Analysis was performed on the Final ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of study end.||Subjects|||Number
140315|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.||Subjects|||Number
140316|NCT00466947|Secondary|Number of Subjects With Solicited General Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.||Subjects|||Number
140317|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset, for the Control Group|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration.|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.||Subjects|||Number
140318|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.||Subjects|||Number
140319|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Booster Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination.||Subjects|||Number
150416|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
140320|NCT00466947|Secondary|Number of Subjects With Solicited Local Symptoms Post Primary Vaccination in the Immunogenicity and Tolerability Subset|Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.|Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration|The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course.||Subjects|||Number
140321|NCT00466947|Secondary|Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects included in the Panama subset.||Subjects|||Number
140322|NCT00466947|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study (Month 0 to Month 22-25)|The analysis was performed on all vaccinated subjects whose data were exploited towards analysis of results at the end of the study.||Subjects|||Number
140323|NCT00466947|Primary|Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)|"A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose.~After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome."|Any time from 2 weeks after Dose 3 up to 31 August 2010|Analysis was performed on the Interim ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject’s data as of 31 August 2010.||Subjects|||Number
140324|NCT00466882|Secondary|Document the Occurrence of Any Adverse Events Including Infection and/or Erosion of the LAPBAND and/or Need for Surgical Revision in LAPBAND||Until recovery from transplant||||||
140325|NCT00466882|Primary|Number of Participants With BMI < 35 kg/m^2 Within 18 Months Following Weight Loss Surgery|See if successful weight loss surgery would allow patients to reduce their preoperative Body Mass Index (BMI in kg/m2) to below 35 kg/m2 within the first 18 months after weight loss surgery in order to see if these patients became eligible for kidney transplantation - most facilities require transplant candidates to have a BMI below 35 kg/m2.|18 months|||participants|||Number
140326|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor composite score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam motor composite score were analyzed||units on a scale||Standard Error|Mean
140327|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment.|only subjects that were randomized and had the 24 month Bayleys exam gross motor score were analyzed||units on a scale||Standard Error|Mean
140328|NCT00466817|Secondary|Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine motor scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam fine motor were analyzed||units on a scale||Standard Error|Mean
140329|NCT00466817|Secondary|Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam language composite score were analyzed||units on a scale||Standard Error|Mean
140330|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam expressive communications scaled score were analyzed||units on a scale||Standard Error|Mean
140331|NCT00466817|Secondary|Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores are between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cognitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|24 months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam cognitive composite score were analyzed||units on a scale||Standard Error|Mean
140332|NCT00466817|Secondary|Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|24 Months after enrollment|only subjects that were randomized and had the 24 month Bayleys exam receptive communication scaled were analyzed||units on a scale||Standard Error|Mean
140333|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).|Motor Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor motor skills) and 160 (excellent motor skills), with the average motor skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam motor composite score were analyzed||units on a scale||Standard Error|Mean
140334|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).|Gross Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor gross motor skills) and 19 (excellent gross motor skills), with the average gross motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam gross motor score were analyzed||units on a scale||Standard Error|Mean
140335|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).|Fine Motor Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor fine motor skills) and 19 (excellent fine motor skills), with the average fine motor skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam fine motor score were analyzed||units on a scale||Standard Error|Mean
140336|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).|Language Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor language skills) and 160 (excellent language skills), with the average language skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam language composite score were analyzed||units on a scale||Standard Error|Mean
140337|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).|Expressive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor expressive communication skills) and 19 (excellent expressive communication skills), with the average expressive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam expressinve Communications scaled score were analyzed||units on a scale||Standard Error|Mean
140338|NCT00466817|Secondary|Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).|Receptive Communication Scaled Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Scaled Scores, the range of scores is between 1 (very poor receptive communication skills) and 19 (excellent receptive communication skills), with the average receptive communication skills score for a child (age adjusted) is 10 with standard deviation of 3.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Receptive Communications scorewere analyzed||units on a scale||Standard Error|Mean
140339|NCT00466817|Secondary|Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).|Cognitive Composite Score for infants and toddlers was measured by use of the Bayley Scales of Infant and Toddler Development. For the Bayleys scoring of the Composite Scores, the range of scores is between 40 (very poor cognitive skills) and 160 (excellent cognitive skills), with the average cogonitive skills score for a child (age adjusted) is 100 with standard deviation of 15.|12 Months after enrollment|only subjects that were randomized and had the 12 month Bayleys exam Cognitive Composite Score were analyzed||units on a scale||Standard Error|Mean
140353|NCT00466687|Primary|Number of Patients With Response|Per Response Evaluation Criteria in Solid Tumor (RECIST): Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At 6 months|Patients for whom a response could be determined. Three patients were not available for measurement of response: no data (2) and toxicity (1).||participants|||Number
140354|NCT00466505|Secondary|Serum TGF-alpha: Treatment Cycle 2|Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 2|on-study week 9|||ng/mL||Standard Deviation|Mean
140340|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.||ears|||Number
140341|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods||ears|||Number
140342|NCT00466817|Secondary|Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported||ears|||Number
140343|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods.||ears|||Number
140344|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects that were randomized and had baseline and 12 month hearing exams were analyzed.||ears|||Number
140355|NCT00466505|Secondary|Urinary PGE-M : Treatment Cycle 2|Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 2|on-study week 9|||ng/mL||Standard Deviation|Mean
140345|NCT00466817|Secondary|Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported||ears|||Number
140346|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 24 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 24 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 24 months|Only subjects randomized and subjects that had both baseline and 24 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 24 months). There were 31 placebo subjects and 37 active drug subjects reported results for both time periods||participants|||Number
140347|NCT00466817|Secondary|Change in Best Ear Hearing Assessments at 12 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 12 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 12 months|Only subjects randomized and subjects that had both baseline and 12 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 12 months). There were 40 placebo subjects and 41 active drug subjects reported results for both time periods||participants|||Number
140348|NCT00466817|Secondary|Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.|Adverse events were assessed at each visit through month 7 of the study. No subject discontinued valganciclovir therapy due to permanent discontinuation of valganciclovir therapy or lead to irreversible outcome of any adverse event.|baseline through 7 months|||participants|||Number
140349|NCT00466817|Primary|Change in Best Ear Hearing Assessments at 6 Months.|Hearing assessment was evaluated by an independent audiologist. At baseline, a brainstem evoked response (BSER) assessment and autoacoustic emissions (OAEs) hearing assessments were obtained. At 6 months, BSER and /or Visual reinforcement audiometry (VRA) and OAEs were obtained. A single, independent study audiologist who was blinded to treatment assignment assessed the audiology test battery for each subject and assigned the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications were assigned by ear (one for the left ear and one for the right ear), giving “total ear” classifications. Following this, the study audiologist assigned the “best ear” classification for the subject at that study visit; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the “best ear” classification was mild hearing loss.|Between baseline and 6 months|Only subjects randomized and subjects that had both baseline and 6 month hearing exams were analyzed for the primary endpoint. Some subjects failed to have the one or both of the two hearing exams (baseline and/or 6 months). There were 43 subject in each group (placebo and active) that had both hearing results reported||participants|||Number
140350|NCT00466687|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Number of patients with worst-grade toxicity at each of five grades following National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 28-day cycle for 6 cycles (168 days)|Patients who received the study drug and who experienced a toxicity. Eleven patients did not experience any toxicity and are therefore not included in the analyzed population for this outcome measure.||participants|||Number
140351|NCT00466687|Secondary|Progression-free Survival at 6 Months|Patients with Progression-free survival at 6 months|6 months|Those patients who were progression-free at 6 months from study entry. No date of progression was available for 7 patients||participants|||Number
140352|NCT00466687|Secondary|Time to Disease Progression.|Time from on study date to date of progression in months, if the progression happened in the patient. Disease progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions with reference to the smallest sum LD since treatment began or the appearance of one or more new lesions.|up to one year after off-study date|Patients with disease progression. Six patients were not available for determination to progression: no data (5) and toxicity (1).||Months||Full Range|Median
140361|NCT00466505|Secondary|Patient Response to Treatment|Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|On study date to off study date in this study with median 9.76 months|||participants|||Number
140362|NCT00466505|Primary|Progression-free Survival (PFS)|Number of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions|On study date to off study date in this study with median 9.76 months|||Days||Full Range|Median
140363|NCT00466323|Primary|Family-Clinician Contact (Not Including Notes From FMPO Clinicians)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||Number of Interactions||Standard Deviation|Mean
140364|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales. This sub score is Overcoming Stuckness.The MHRM sub scales range from 0-16, with a higher score indicating better recovery.|Within 6 month of the intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||units on a scale||Standard Deviation|Mean
140365|NCT00466323|Secondary|Consumer's Recovery Rating - MHRM Total Score|We measured recovery attitudes and beliefs with the Mental Health Recovery Measure (MHRM), a 30-item self-report measure that has a total score and eight subscales.The MHRM scales range from 0-120, with a higher score indicating better recovery.|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||Units on a Scale||Standard Deviation|Mean
140366|NCT00466323|Primary|Family-Clinician Contact (Including Contact With FMPO Clinician)|Chart review looking at the any clinician contact with veteran's family members|Within 6 months of intervention|We enrolled (consented and baseline) 238 individuals. Over the course of the study, we withdrew 6 individuals. We only conducted analysis on the 232 remaining individuals.||Number of Interactions||Standard Deviation|Mean
140367|NCT00466310|Primary|Total Plasmalogen Levels in the Lipid Profile|Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.|Baseline|17 of the 31 available controls were age and BMI matched to the schizophrenia subjects.||nmoles/gram||Standard Deviation|Mean
140368|NCT00466206|Primary|Efficacy: Patient Recommendation of Treatment|"Based on patient response to one-year post-explantation QoL statement: I would recommend this treatment for pectus excavatum (sunken chest) to someone else with pectus excavatum. Ratings: 5-strongly agree; 4-agree; 3-unsure; 2-disagree; 1-strongly disagree"|One year post-explanation|Per protocol||Scores on a scale||Standard Deviation|Mean
140369|NCT00466206|Primary|Efficacy: Patient Satisfaction|Based on patient response to one-year post-explantation QoL questionnaire: How satisfied are you with the correction of your chest? Ratings: 5-very satisfied; 4-satisfied; 3-unsure; 2-dissatisfied; 1-very dissatisfied|One year post-explant|Per protocol||Scores on a scale||Standard Deviation|Mean
140370|NCT00466206|Primary|Damage/Discoloration to Skin|Outcome measure is number of patients who experienced permanent skin damage or discoloration due to external brace wear|One-month post-explant|Per protocol||participants|||Number
140371|NCT00466206|Secondary|Patient Compliance|Compliance measured by average number of hours per day external device was worn by patient, as measured by the data sensor and logging device built into external prosthetic|18 months active Rx|Per protocol||avg hours per day brace worn||Full Range|Mean
140372|NCT00466206|Primary|Affect on Cardiac Activity|EKG performed prior to implantation, one month post-implantation, and after explanation to evaluate whether magnetic field near the heart adversely affects cardiac activity. Outcome measure describes number of patients who experienced adverse change in EKG.|One month post-explantation|Per protocol, this is a single-arm, pilot study of ten subjects.||participants|||Number
140373|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.|Weeks 1 to 4|Safety population: participants who took at least one dose of study medication post-randomization.||units on a scale||95% Confidence Interval|Least Squares Mean
140374|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
140375|NCT00466193|Secondary|Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline|Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.|Weeks -1 to 0|Safety population: participants who took at least one dose of study medication post-randomization.||units on a scale||95% Confidence Interval|Least Squares Mean
140376|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
140377|NCT00466193|Secondary|Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline|The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
140378|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
140379|NCT00466193|Secondary|Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.|Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||percentage of participants|||Number
140380|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks 1 to 4|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
140381|NCT00466193|Secondary|Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline|Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
140382|NCT00466193|Primary|Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline|Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?|Weeks -1 to 0|Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value.||minutes||95% Confidence Interval|Least Squares Mean
140383|NCT00466167|Secondary|Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)||baseline and week 18|Treated set (TS 1) population: defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication and were treated for 18 weeks (or had discontinued treatment prior to week 18). Data limited to visit 8 (or V11 in case of premature discontinuation before visit 8).||participants|||Number
140384|NCT00466167|Secondary|Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18|Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for “no pain” to ten for “unbearable pain”.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||units on a scale||Standard Error|Least Squares Mean
140385|NCT00466167|Secondary|Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks|ranging from 0 (worst case) to 100 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
140386|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks|Ranging from 0 (best case) to 156 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
140387|NCT00466167|Secondary|Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks|ranging from 0 (worst case) to 150 (best case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
140388|NCT00466167|Secondary|Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks|ranging from 0 (best case) to 63 (worst case)|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
140389|NCT00466167|Secondary|Change From Baseline in UPDRS IV Score After 18 Weeks|UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
140390|NCT00466167|Secondary|Change From Baseline in UPDRS III Score After 18 Weeks|UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
140391|NCT00466167|Secondary|Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period|UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.|baseline and 18 weeks|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Units on a scale||Standard Error|Least Squares Mean
144303|NCT00433771|Secondary|Time to Stent Occlusion|Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.|Until 6 Months or death|Only 1 subject experienced stent occlusion during the study.||Days|||Number
140394|NCT00466167|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Responder|CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)|after 18 weeks of treatment|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Participants|||Number
140395|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of on-time||Standard Error|Least Squares Mean
140396|NCT00466167|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of on-time||Standard Error|Least Squares Mean
140397|NCT00466167|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of on-time without dyskinesia||Standard Error|Least Squares Mean
140398|NCT00466167|Secondary|Change From Baseline in Percentage Off-time at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).|baseline and week 18|Full analysis set (FAS 1) population with last observation carried forward (LOCF).||Percentage of off-time||Standard Error|Least Squares Mean
140399|NCT00466167|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms|baseline and week 18|Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment||Percentage of change from baseline||Standard Error|Least Squares Mean
140400|NCT00465998|Secondary|Delivery Within 24 Hours|Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis.|Time from induction to delivery|Hazard ratio was reported.||Hazard ratio||95% Confidence Interval|Number
140401|NCT00465998|Primary|Vaginal Delivery in Induced Labors|The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head–perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.|Time from induction of labor to delivery|||percentage of area under the ROC curve||95% Confidence Interval|Number
140402|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III.||48 weeks after study start|Intention to treat (ITT) population.||pg/mL||Standard Deviation|Mean
140403|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II.||32 weeks after study start|Intention to treat (ITT) population.||pg/mL||Standard Deviation|Mean
140404|NCT00465985|Secondary|Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I.||until Week 8|Intention to treat (ITT) population.||pg/mL||Standard Deviation|Mean
140405|NCT00465985|Primary|Number of Participants Who Experienced a Disease Flare in Part II|Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) > 30 mg/L and either a PGA > minimal, or PGA equal to minimal and > minimal SD.|32 weeks after study start|||Participants|||Number
140406|NCT00465985|Secondary|Pharmacokinetics (CLD (L/d))|Assessed serum clearance of ACZ885.|48 weeks after study start|Patients in Part I and Part II who received at least one dose of ACZ885.||L/day||Standard Deviation|Mean
140407|NCT00465985|Secondary|Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.||Week 8 and Week 32|Intention to treat (ITT)population and LOCF.||mg/L||Standard Deviation|Mean
140408|NCT00465985|Secondary|Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)|"A 5-point scale was used for the Physician’s global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items:~skin disease (urticarial skin rash)~arthralgia~myalgia~headache/migraine~conjunctivitis~fatigue/malaise~other symptoms related to autoinflammatory syndrome~other symptoms not related to autoinflammatory syndrome"|32 weeks after study start|||Participants|||Number
140409|NCT00465985|Secondary|Number of Participants With Treatment Response in Part I (After 8 Weeks)|Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by >30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA > 30 mg/L and either PGA > minimal or PGA = minimal and SD > minimal. Non-responders = no PR by Day 8 or no CR by Day 15.|8 weeks after study start|||Participants|||Number
140410|NCT00465985|Primary|Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part)|Determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II.|32 weeks after study start|||percent of participants|||Number
140413|NCT00465894|Secondary|Subjective Patient Improvement in Irritative Urinary Symptoms at 24 and 52 Weeks Post Intervention Initiation|"OAB-q Symptom Bother Score~Health Related Quality of Life (HRQL) portion of the OAB-q~Patient Global Impression of Improvement (PGI-I)~Patient Satisfaction Questionnaire (PSQ)"|After 24 and 52 Weeks of Intervention||01/2017||||
140414|NCT00465894|Secondary|Subjective Patient Improvement in Irritative Urinary Symptoms at 12 Weeks Post Intervention Initiation|"Health Related Quality of Life (HRQL) portion of the OAB-q~Patient Global Impression of Improvement (PGI-I)~Patient Satisfaction Questionnaire (PSQ)~3-Day Voiding Diary"|After 12 Weeks of Intervention||01/2017||||
140415|NCT00465894|Primary|Subjective Patient Improvement in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at 12 Weeks Post Intervention Initiation|OAB-q scoring ranges from a lowest score of 8 to the highest score of 48. The higher score reflects greater severity of symptoms. The derived score is (actual score - lowest raw score) divided by possible raw score range (40) times 100. Hence, the lowest score is 0 and the highest score is 100, with 100 being indicative or greater symptom severity. The mean and the standard deviation is reported for both arms.|After 12 Weeks of Intervention|||units on a scale|Participants|Standard Deviation|Mean
140416|NCT00465816|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
140417|NCT00465816|Secondary|Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits||During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
140418|NCT00465816|Secondary|Number of Subjects Reporting Any Rash|Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
140419|NCT00465816|Secondary|Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses|Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.|During the entire study (up to Month 7)|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
140420|NCT00465816|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to 1 month after each vaccine dose|The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.||Subjects|||Number
140421|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache.|During a 4-day period after any vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet.||Subjects|||Number
140422|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day period after each Twinrix vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Twinrix were assessed.||Subjects|||Number
140423|NCT00465816|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day period after Nimenrix vaccination|The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed.||Subjects|||Number
140424|NCT00465816|Secondary|Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||Subjects|||Number
140425|NCT00465816|Secondary|IgG Anti-HBs Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
140426|NCT00465816|Secondary|Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value|The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||Subjects|||Number
140427|NCT00465816|Secondary|Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations|Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).|Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||milli-Internatinal Units per Milliliter||95% Confidence Interval|Geometric Mean
141327|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Entry|Immunogenicity was assessed for each serogroup by the number of participants with protective antibody levels (titers greater than or equal to 1:128)|At 3.5 years (Step 3 entry)|All participants who had antibody data for Step 3 Week 0||participants|||Number
140428|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||Subjects|||Number
140429|NCT00465816|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|At Month 7|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
140430|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|At Month 7|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
140431|NCT00465816|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7|The rSBA titers were expressed as geometric mean titers.|At Month 7|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Titer||95% Confidence Interval|Geometric Mean
140432|NCT00465816|Secondary|Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value|The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
140433|NCT00465816|Secondary|Anti-Tetanus Toxoid (TT) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||International Units per milliliter||95% Confidence Interval|Geometric Mean
140434|NCT00465816|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values|The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||Subjects|||Number
140435|NCT00465816|Secondary|Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations|Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested for anti-PSA and anti-PSC antibodies by Enzyme-linked Immunosorbent assay (ELISA) while the other half were tested for anti PSW-135 and anti-PSY antibodies by ELISA.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
140436|NCT00465816|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values|The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.|Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
140437|NCT00465816|Secondary|Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135|Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Subjects|||Number
140438|NCT00465816|Primary|Number of Subjects Seroprotected for Hepatitis B|A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.||Subjects|||Number
140439|NCT00465816|Primary|Number of Subjects Seroconverted for Hepatitis A|A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.|At 1 month after the third dose of Twinrix vaccine (Month 7)|The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on initially seronegative subjects in those groups that received the Twinrix vaccine.||Subjects|||Number
140440|NCT00465816|Primary|Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers|The rSBA titers were expressed as geometric mean titers.|At 1 month after vaccination with Nimenrix vaccine (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.||Titer||95% Confidence Interval|Geometric Mean
140441|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140442|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140443|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140444|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140445|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140446|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140447|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140457|NCT00465738|Secondary|Investigator’s Global Assessment of Treatment Response (GATR) - Full Analysis Set|The investigator’s global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||units on a scale||Standard Error|Mean
140448|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140449|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140450|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140451|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140452|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140453|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140454|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140455|NCT00465738|Secondary|Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding|Response is defined as an improvement (increase) of at least one point in the Barthel Index from baseline visit. The Barthel Index was assessed for the items feeding, grooming, toilet use, bathing and dressing. Feeding: 0 = unable; 1 = needs help cutting, spreading butter etc.; 2 = independent; Grooming: 0 = needs help with personal care; 1 = independent face/hair/teeth/shaving; Toilet use: 1 = need some help, but could do something alone; 2 = independent; Bathing: 0 = dependent; 1 = independent; Dressing: 0 = dependent; 1 = needs help but could do about half unaided; 2 = independent.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140456|NCT00465738|Secondary|Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set|The patient’s global assessment of response to treatment were determined with the use of the Global Response Scale using the following scores: -4 = very marked worsening; -3 = marked worsening; -2 = moderate worsening; -1 = mild worsening; 0 = no change; +1 = mild improvement; +2 = moderate improvement; +3 = marked improvement; +4 = very marked improvement.|week 4|Full Analysis Set||units on a scale||Standard Error|Mean
140458|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
140459|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
140460|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
140461|NCT00465738|Secondary|Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension|For the PROM all motions of wrist and elbow were measured from a defined neutral starting point position. The degrees of motion were added in the direction the wrist and elbow moved from the neutral starting position. The neutral starting position was the position of an upright standing/sitting person. The angle of the motion from the neutral starting position was measured in degrees using a goniometer. Angles were measured for the wrist with maximal dorsal extension, neutral position and maximal palmar flexion, and for the elbow with maximal extension, neutral position and maximal flexion.|baseline, week 4, week 12, follow up (between week 12 and week 20)|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||degree||Standard Error|Mean
140462|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140463|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140464|NCT00465738|Secondary|Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140465|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140466|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140467|NCT00465738|Secondary|Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140468|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140469|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140497|NCT00465101|Other Pre-specified|Number of Fibers Used During Procedure||Procedure|Participants who received the study treatment and for whom the outcome is available.||number of fibers used||Standard Deviation|Mean
140470|NCT00465738|Secondary|Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140471|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140472|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140473|NCT00465738|Secondary|Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140474|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140475|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140476|NCT00465738|Secondary|Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set|Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a “catch” when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140477|NCT00465738|Secondary|Responder in FAT at Follow up - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140478|NCT00465738|Secondary|Responder in FAT at Week 12 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140479|NCT00465738|Secondary|Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set|Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5.|Week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140480|NCT00465738|Secondary|Responder in DAS at Follow up - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|follow up visit, between week 12 and week 20|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140481|NCT00465738|Secondary|Responder in DAS at Week 12 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 12|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140482|NCT00465738|Secondary|Responder in DAS at Week 4 - Full Analysis Set|Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit.|week 4|Analysis is based on Full Analysis Set, defined as all randomized subjects who received at least one dose of study drug. Missing values were not imputed.||participants|||Number
140483|NCT00465738|Primary|Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set|The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target.|At week 4|Analysis is based on Per Protocol Set, defined as all randomized subjects who received at least one dose of study drug and who have no major deviation from study protocol. For this set of subjects no missing values can occur for the primary endpoint.||participants|||Number
140484|NCT00465647|Secondary|Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time|"The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = no pain and 10 = most pain, was used by children ≥ 12 years of age."|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).||unit on a scale||Standard Error|Mean
140485|NCT00465647|Secondary|Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time|Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.|Immediately prior to first oral dose with potentially up to 54 hours duration.|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).||units on a scale||Standard Error|Mean
140486|NCT00465647|Secondary|Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]|There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.|Immediately prior to first oral dose, up to 54 hours|The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).||units on a scale||Standard Error|Mean
140487|NCT00465647|Primary|Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)|"Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study.~Efficacy was based on Oral treatment only."|A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.|The full analysis population for Pharmacokinetics/ Pharmacodynamics consisted of subjects who received at least 1 dose of oral hydromorphone HCl, and had at least 1 valid quantifiable PK sample. To be a valid sample, the time of administration of each dose of oral hydromorphone HCl, the dose, and the time of sample collection must be recorded.||L/hour||95% Confidence Interval|Number
140488|NCT00465530|Primary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|3 Weeks to Follow-Up (7 Weeks)|||units on a scale||Standard Deviation|Mean
140489|NCT00465530|Secondary|Change in Overall Quality of Life|Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.|Baseline to 3 Weeks|||units on a scale||Standard Deviation|Mean
140490|NCT00465530|Primary|Change in Computed Tomography (CT) Score After Treatment|Change in CT score reflects the Lund-Mackay staging system. Each sinus is scored separately and scores are determined for the right and the left side. The lowest score of 0 represents no opacification in the sinus. A score of 1 represents a partial opacification. A score of 2 represents complete opacification.|Change from Baseline to 6 Weeks|||units on a scale||Standard Deviation|Mean
140491|NCT00465361|Primary|Presence of Resident Surveillance Behaviors of Specific Aspects of Developmental Status at the Two Month Preventive Care Visit|Residents were observed to determine whether specific aspects of infant developmental status, as part of developmental surveillance, were assessed during the two-month preventive care visit. The components of developmental surveillance observed were: assessment of the infant's ability to follow past midline, assessment of the infant's ability to lift his/her head off of the table in prone, assessment of the infant's ability to hold an object placed in his/her hand, assessment of the infant's ability to coo, and assessment of the infant's ability to demonstrate a social smile.|Residents were observed during each of the eligible preventive care visits. Each visit was an average of 20 minutes in length. Preventive care visits were observed over a 13 month time period.|||Participants|||Number
140492|NCT00465179|Secondary|Median Overall Survival|Overall survival was estimated using the Kaplan-Meier method.|Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.|||months||95% Confidence Interval|Median
140493|NCT00465179|Primary|Median Progression-Free Survival (PFS)|Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.||months||95% Confidence Interval|Median
140494|NCT00465179|Primary|Number of Participants With Response to Treatment|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years|Two participants were not evaluable as one was taken off study due to adverse event and the other due to withdrawal of consent.||participants|||Number
140495|NCT00465101|Secondary|Occurrence of Retrograde Ejaculation|Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.|5 Year Follow Up|Participants who received the study treatment||percentage of subjects with RE||95% Confidence Interval|Number
140496|NCT00465101|Other Pre-specified|Total Joules Used|Total energy applied during the study procedure|Procedure|Participants who received the study treatment and for whom the outcome measure is available.||kilojoules (kJ)||Standard Deviation|Mean
140503|NCT00465101|Secondary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.|5 Years|Participants who received the study treatment and for whom the outcome measure is available.||Percent of subjects w/ treatment success||95% Confidence Interval|Number
140504|NCT00465101|Secondary|Gross Hematuria|Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.|91 days|Participants who received the study treatment||Percentage of subjects|||Number
140505|NCT00465101|Secondary|Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.|"Participant response to the question If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Values range from 0 (Delighted) to 6 (Terrible) with higher values indicating worse outcomes."|5 years|Participants who received the study treatment and for whom the outcome measure is available.||Score on a scale||Standard Deviation|Mean
140506|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.|A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.||percentage of patients improved||95% Confidence Interval|Number
140507|NCT00465101|Secondary|Percentage of Participants With Clinically-significant Improvement in Uroflow.|A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months|6 months post-treatment|Participants who received the study treatment and for whom the outcome measure is available.||percentage of patients improved||95% Confidence Interval|Number
140508|NCT00465101|Secondary|Treatment-related Complication|"Treatment-related events include the following:~Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization~Perforation / injury of adjacent organ(s)~Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal~Hematuria requiring transfusion~Urinary retention requiring corrective intervention~De novo erectile dysfuction (ED)~Transfusion secondary to procedure-related anemia~Post procedure incontinence secondary to damage to the external urinary sphincter~Any other treatment-related injury requiring intervention"|3 months|Participants who received the study treatment.||percentage of subjects with complication||95% Confidence Interval|Number
140509|NCT00465101|Primary|Percentage of Participants With Treatment Success|Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50%|6 months|Participants who received the study treatment and for whom the outcome measure is available.||percentage of participants|||Number
140510|NCT00465088|Secondary|Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12|NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline value for all 3 lipid parameters||Percentage of subjects|||Number
140511|NCT00465088|Secondary|Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12||12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline triglyceride value||Percentage of subjects|||Number
140512|NCT00465088|Secondary|Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12|For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.|12 weeks|All treated subjects not meeting NCEP ATP III goals at baseline with both a baseline and at least 1 postbaseline LDL-C value||Percentage of subjects|||Number
140513|NCT00465088|Secondary|Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12||12 weeks|All treated subjects not meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III goals at baseline with both a baseline and at least 1 postbaseline HDL-C value||Percentage of subjects|||Number
140514|NCT00465088|Secondary|Percent Change in Lipoprotein A From Baseline to Week 12|(Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||Inter-Quartile Range|Median
140515|NCT00465088|Secondary|Percent Change in Total Cholesterol:HDL-C Ratio|(Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
140516|NCT00465088|Secondary|Percent Change in Total Cholesterol From Baseline to Week 12|(Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
140517|NCT00465088|Secondary|Percent Change in LDL-C:HDL-C Ratio|(Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio|From baseline to Week 12|All treated subjects whose Week 12 values were obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
140518|NCT00465088|Secondary|Percent Change in Triglycerides From Baseline to Week 12|(Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||Inter-Quartile Range|Median
140519|NCT00465088|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12|(Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window (between 70 days after first dose and not more than 3 days after last dose)||percent change||95% Confidence Interval|Least Squares Mean
140520|NCT00465088|Secondary|Percent Change in Non-HDL-C From Baseline to Week 12|(Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C|From baseline to Week 12|All treated subjects whose Week 12 value was obtained within the Week 12 visit window||percent change||95% Confidence Interval|Least Squares Mean
140524|NCT00464945|Primary|Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population were participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
140525|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after toddler dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
140526|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants (268) who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
140527|NCT00464945|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
140528|NCT00464945|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
140529|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 50, 33 and 22 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.||score on a scale||Standard Deviation|Mean
140530|NCT00464737|Secondary|Number of Subjects With Presence of Impulse Control Disorders|Impulse control disorders (ICDs) are a set of psychiatric disorders in which a person is unable to control strong and often harmful impulses. They are assessed in this study using the Jay Modified Minnesota Impulsive Disorders Interview (Jay Modified MIDI), which focuses on the five most common ICDs that may be associated with dopamine agonist use: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding (performing repetitive and/or mechanical tasks).|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
140531|NCT00464737|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) Scores to the Last Assessment in the 12-week Treatment Phase|The Beck Depression Inventory-II is a 21-item questionnaire. Each item is scored on a scale of 0 to 3 with a total score ranging from 0 to 63. A higher total score is associated with more severe depressive symptoms.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
140532|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
140533|NCT00464737|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
149820|NCT00389493|Primary|Score on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|Y-BOCS ranges from 0-40, with 0 meaning no symptoms and higher numbers meaning greater symptom severity|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
140534|NCT00464737|Secondary|Rotigotine Plasma Concentration at the End of the Maintenance Phase/Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 73 (Rotigotine 4 mg) and 74 (Rotigotine 8 mg) patients respectively in the Safety Set, a total of 41 and 20 patients respectively at the end of Maintenance Phase/Week 12 have this assessment.||ug/ML||Standard Deviation|Mean
140535|NCT00464737|Secondary|Number of Subjects Using Rescue Medication and Alcohol During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response. Use of alcohol to treat pain in the past 24 hours was recorded with a Yes/No response.|12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
140536|NCT00464737|Secondary|Change From Baseline in Morning and Evening Pain Scores to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
140537|NCT00464737|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 76, 58, and 51 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Patients|||Number
140538|NCT00464737|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
140539|NCT00464737|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
140540|NCT00464737|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Based on the observed outcome for the primary efficacy variable for this study, an abbreviated clinical study report was produced. Summaries were not produced for all pre-planned outcome measures and thus these results are not available. This summary was not produced for the abbreviated clinical study report.|||||
140541|NCT00464737|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 80, 64 and 63 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
140542|NCT00464737|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 82 (Placebo), 74 (Rotigotine 4 mg), and 74 (Rotigotine 8 mg) patients randomized, 81, 70 and 72 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
140543|NCT00464711|Primary|Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores|"The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8.~40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks."|12 weeks|40 patients (21 female) with MDD enrolled in the 12 week study, 25 patients (15 Female) completed. Current analyses are based on completers only.||participants|||Number
140544|NCT00464685|Secondary|Time to Retreatment in the Study Eye|Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.|12 Months|Intent to Treat: all randomized patients||Days||95% Confidence Interval|Median
140545|NCT00464685|Secondary|Change From Baseline in the Focal Leakage Area in the Study Eye|Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 12|Intent to Treat: all randomized patients||Millimeters Squared (mm^2)||Standard Deviation|Mean
140546|NCT00464685|Secondary|Change From Baseline in Central Subfield Retinal Thickness in the Study Eye|Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients||Microns||Standard Deviation|Mean
140547|NCT00464685|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients||Letters Read Correctly||Standard Deviation|Mean
140548|NCT00464685|Primary|Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 12|Intent to Treat: all randomized patients||Percentage of Patients|||Number
140549|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age|Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.|21 days after vaccination|The analysis was done on the per protocol population||Titers||95% Confidence Interval|Geometric Mean
140550|NCT00464672|Secondary|Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.|Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.|7 days after each vaccination|The analysis was performed on the safety population.||Participants|||Number
140551|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age|To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP)population.||Titers||95% Confidence Interval|Geometric Mean
140552|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Mean
140553|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.|50 days after last vaccination|The analysis was performed on the per-protocol (PP) population||Percentage of participants||95% Confidence Interval|Mean
140554|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age|Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.|7 days after vaccination|The analysis was performed on the safety population.||Participants|||Number
140555|NCT00464672|Secondary|Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age|To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population||Titers||95% Confidence Interval|Geometric Mean
140556|NCT00464672|Secondary|Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP)population.||Percentage of participants||95% Confidence Interval|Mean
140557|NCT00464672|Secondary|Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age|To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of subjects||95% Confidence Interval|Mean
140558|NCT00464672|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age|Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.|7 days after vaccination|The analysis was performed on the safety population.||participants|||Number
140559|NCT00464672|Primary|Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age|Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.||Percentage of participants||95% Confidence Interval|Mean
140560|NCT00464672|Primary|Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age|To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.|21 days after vaccination|The analysis was performed on the per-protocol (PP) population.||Percentages of participants||95% Confidence Interval|Mean
140561|NCT00464646|Secondary|Percentage of Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)||2-4 weeks after surgery and at 9 and 12 months from study entry||||||
140562|NCT00464646|Secondary|Overall Survival||From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry||||||
149821|NCT00389467|Secondary|Day 90 Mortality||at day 90|||participants|||Number
140564|NCT00464646|Secondary|Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)||Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry||||||
140565|NCT00464646|Secondary|Clinical Complete Response (cCR)||Determined at baseline, between EC and docetaxel, and following docetaxel (before surgery)||||||
140566|NCT00464646|Secondary|pCR in the Breast (Cohort A)||Assessed at the time of surgery||||||
140567|NCT00464646|Primary|Cardiac Event Rate as Determined by LVEF Assessment||Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.||||||
140568|NCT00464646|Primary|Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)|The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.|Assessed at time of surgery on average at 8 months|73 of the 76 patients in Cohort A were analyzed: 2 patients did not have surgery and 1 patient did not have the nodal status determined.||participants|||Number
140569|NCT00464542|Secondary|Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy|The time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy|30 days after cessation of metronidazole therapy|||Days||Full Range|Median
140570|NCT00464542|Primary|Number of Participants With Bacterial Vaginosis Recurrence|Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.|30 days after cessation of metronidazole therapy|per protocol||Participants|||Number
140571|NCT00464490|Primary|Mechanical Ventilation Time||time from first weaning attempt to successful extubation|||hours||Standard Deviation|Mean
140572|NCT00464464|Primary|Hamilton Depression Rating Scale: Follow-Up Evaluation|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|14 weeks|||units on a scale||Standard Deviation|Mean
140573|NCT00464464|Primary|Hamilton Depression Rating Scale: Endpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|10 weeks|||units on a scale||Standard Deviation|Mean
140574|NCT00464464|Primary|Hamilton Depression Rating Scale: Midpoint|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|5 weeks|||units on a scale||Standard Deviation|Mean
140575|NCT00464464|Primary|Hamilton Depression Rating Scale: Baseline|"This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial.~The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology."|0 weeks|||units on a scale||Standard Deviation|Mean
140576|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7|"Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,~+3=severe)."|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"||Percentage of Patients|||Number
140577|NCT00464438|Secondary|Percentage of Patients With Improvement in Ocular Signs for Lid Erythema|Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Days 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"||Percentage of Patients|||Number
140578|NCT00464438|Secondary|Percentage of Patients With Microbiological Improvement|Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria"||Percentage of Patients|||Number
140624|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization|Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.|up to 48 hours|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Hours||Standard Deviation|Mean
140579|NCT00464438|Primary|Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7|Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).|Day 7|"Modified Intent to Treat; defined as all randomized patients who were culture positive at baseline meaning the culture of the eye grew bacteria."||Percentage of Patients|||Number
140580|NCT00464334|Primary|Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies|The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.|Baseline and Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.||fold change||95% Confidence Interval|Geometric Mean
140581|NCT00464334|Primary|Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7|The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).|Month 7|Population consists of all participants who received three doses of vaccine and had no protocol violations. No participants in the V950 50 mcg/IMX 0 mcg group had data for the Month 7 evaluation.||ng/mL||95% Confidence Interval|Geometric Mean
140582|NCT00464334|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 6 months after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.||participants|||Number
140583|NCT00464334|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to 4 years after first dose of vaccine|Population consists of all participants who received at least one dose of vaccine.||participants|||Number
140584|NCT00464308|Secondary|The Mean Percentage of Participants With 24-hour Heartburn Symptom Free Periods||4 weeks|||percent of participants||95% Confidence Interval|Mean
140585|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Regurgitation Symptoms by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds ‘mild’ (symptoms must be absent, very mild, or mild)assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|4 weeks|||participants|||Number
140586|NCT00464308|Primary|The Number of Patients Achieving Satisfactory Resolution of Heartburn by Week 4|Satisfactory resolution, which is achieved if, on any 7 consecutive days within the 4 week period, the severity of symptoms never exceeds ‘mild’ (symptoms must be absent, very mild, or mild) assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks|Symptom scores 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe||participants|||Number
140587|NCT00464308|Primary|The Number of Patients Achieving Complete Resolution of Regurgitation Symptoms at Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes various symptoms as follows: 0-none, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5-Very Severe.|4 weeks|||participants|||Number
140588|NCT00464308|Secondary|The Median Time to Complete Relief of Regurgitation Symptoms||4 weeks|ITT population||days||95% Confidence Interval|Median
140589|NCT00464308|Secondary|The Median Time to Complete Resolution of Heartburn Symptoms.||week 4 of treatment|ITT population||days||95% Confidence Interval|Median
140590|NCT00464308|Primary|The Number of Patients With Complete Resolution of Heartburn by Week 4|Complete resolution is the absence of symptoms for any 7 consecutive days within the 4 week period assessed by the PAGI-SYM scale. This likert scale describes a series of symptoms as follows: 0-None, 1-Very Mild, 2-Mild, 3-Moderate, 4-Severe, 5 Very Severe.|week 4 of treatment|The intent-to-treat (ITT) population was used for all efficacy analyses. The data were reanalysed using the compliance population (defined as all subjects who consumed at least 80% of study medication and who completed at least 80% of data recording).||participants|||Number
140591|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140625|NCT00464204|Secondary|Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition|Time from start of fluid resuscitation with study drug to start of enteral nutrition.|Until start of enteral nutrition (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Hours||Standard Deviation|Mean
140626|NCT00464204|Secondary|Quantity of Study Drug in 4 Days|Total quantity of study drug infused over four consecutive days in the ICU|4 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Milliliter||Standard Deviation|Mean
140592|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140593|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140594|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140595|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140596|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.|From Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140597|NCT00464269|Secondary|Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit|The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
150887|NCT00380250|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|||Scale score||Standard Deviation|Mean
140598|NCT00464269|Secondary|Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit|Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'|Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
140599|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Depression Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140600|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score|The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140601|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Basline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140602|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140603|NCT00464269|Secondary|Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score|"The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item.~The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||units on a scale||Standard Deviation|Mean
140604|NCT00464269|Secondary|Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period|This Outcome Measure was planned to be analyzed by pooling the present study with the other 2 Phase 3 studies (N01252 and N01254). If applicable, a detailed description of the pooled analysis will be provided in a separate analysis plan and results will be described in a separate report.|Baseline to 12-week Treatment Period||||||
140627|NCT00464204|Secondary|Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization|Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Hours||Standard Deviation|Mean
145082|NCT00427635|Secondary|Change From Baseline in Number of Weakly Acidic Reflux Episodes|Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
140605|NCT00464269|Secondary|Time to Tenth Type I Seizure During the 12-week Treatment Period|The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||days||95% Confidence Interval|Median
140606|NCT00464269|Secondary|Time to Fifth Type I Seizure During the 12-week Treatment Period|The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||days||95% Confidence Interval|Median
140607|NCT00464269|Secondary|Time to First Type I Seizure During the 12-week Treatment Period|The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||days||95% Confidence Interval|Median
140608|NCT00464269|Secondary|Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period|"Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as:~(total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
140609|NCT00464269|Secondary|Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period|"Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %.~Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||percentage of participants|||Number
140610|NCT00464269|Secondary|Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week|"Percent change from Baseline was calculated as percent reduction by:~(weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline).~The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline."|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||Percent reduction in POS frequency||Inter-Quartile Range|Median
140611|NCT00464269|Secondary|All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period|"There are three different types of seizures:~Type I: Partial seizures~Type II: Generalized seizures~Type III: Unclassified epileptic seizures.~All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||seizures per week||Inter-Quartile Range|Median
140612|NCT00464269|Secondary|Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||participants|||Number
140645|NCT00463801|Secondary|Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE||At day 14||||||
140646|NCT00463801|Secondary|Efficacy Assessed by Time of Resolution of Infection|Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature ≤37.5°C).|At day 14||||||
140647|NCT00463801|Secondary|Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous||At day 14||||||
140613|NCT00464269|Primary|Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period|"Partial (Type I) seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to generalized tonic-clonic convulsions.~Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as:~(Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)"|Baseline to 12-week Treatment Period|The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.||seizures per week||Inter-Quartile Range|Median
140614|NCT00464204|Other Pre-specified|Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification|"Risk, Injury, Failure, Loss, End-stage kidney disease (RIFLE) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study.~RIFLE comprises five categories: Risk (R), Injury (I), Failure (F), Loss (L), End-stage kidney disease (E) (worst outcome). R, I and F are based on increase in serum creatinine. L and E are based on administration of renal replacement therapy."|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug||Participants|||Number
140615|NCT00464204|Other Pre-specified|Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification|Acute Kidney Injury Network (AKIN) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. AKIN ranges from stage 1 to stage 3 (worst outcome). Stages differ in serum creatinine increase. Stage 1: Increase ≥ 0.3mg/dL or ≥ 150%-200% from reference; Stage 2: Increase ≥ 200%-300% from reference; Stage 3: Increase >300% from reference with an acute increase of at least 0.5mg/dL or renal replacement therapy.|From screening to end of follow-up|Treated population (TRT) = all randomized patients treated with study drug||Participants|||Number
140616|NCT00464204|Other Pre-specified|Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening|Acute Renal Failure (ARF) was defined as a two fold increase in serum concentration over the value at screening at any time after screening.|From screening to end of follow-up (up to day 90)|Treated population (TRT) = all randomized patients treated with study drug. Patients without ARF were excluded from analysis if they had no creatinine value at Screening or no post-screening creatinine value.||Participants|||Number
140617|NCT00464204|Other Pre-specified|Mortality|Mortality was reported for the time period from Screening until the end of follow-up.|From Screening to end of Follow-up|Treated population (TRT) = all randomized patients treated with study drug. Two patients in the Voluven® arm died due to non-treatment emergent SAEs.||Participants|||Number
140618|NCT00464204|Secondary|Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4|"The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC).~The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome)."|From Screening to Day 4|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||Scores on a scale||Standard Deviation|Mean
140619|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient."||Days||Standard Deviation|Mean
140620|NCT00464204|Secondary|Length of Stay in the Hospital|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from hospital (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient."||Days||Standard Deviation|Mean
140621|NCT00464204|Secondary|Length of Stay in the ICU|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., worst possible value).|Until discharge from ICU (up to Day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Imputed with the longest possible duration for patients who died before end of the study of the individual patient."||Days||Standard Deviation|Mean
140622|NCT00464204|Secondary|Length of Stay in the Intensive Care Unit (ICU)|Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).|Until discharge from ICU (up to day 90)|"Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.~Calculated for patients who did not die before end of study of the individual patient"||Days||Standard Deviation|Mean
140623|NCT00464204|Secondary|Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition|This amount will be calculated from start of enteral nutrition until 7 am of day 8|7 days|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization||kcal||Standard Deviation|Mean
141866|NCT00454181|Secondary|Total Surface Area of the Lips Covered by Warts|Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area|24 weeks, from baseline to the end of treatment|Per protocol - only a sub-set of subjects had lip warts at study entry||participants|||Number
140628|NCT00464204|Primary|Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization|Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.|until hemodynamic stabilization (up to 48 hours)|Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.||Milliliter||Standard Deviation|Mean
140629|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after PCI|||participants|||Number
140630|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after randomization, during PCI|||participants|||Number
140631|NCT00464087|Secondary|Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis|Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis|during index hospitalization|||participants|||Number
140632|NCT00464087|Primary|The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge|Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria)|During hospitalization, after Fondaparinux administration, prior to randomization|||participants|||Number
140633|NCT00463866|Secondary|Mean Cost Per Participant Per Country|Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.|6 months||||||
140634|NCT00463866|Secondary|The Mean Total Daily Dose of Steroids From Symbicort.|The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.|4 weeks|: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group.||μg budesonide per day||Standard Deviation|Mean
140635|NCT00463866|Secondary|Mean Overall Asthma Control Questionnaire (ACQ) Score|The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.|6 months.|Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group.||Scores in a scale||Full Range|Mean
140636|NCT00463866|Secondary|Percent of Participants With a Well Controlled Asthma Week.|The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.|6 months.|Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group.||Percentage of participants||Full Range|Mean
140637|NCT00463866|Secondary|Mean Daily Number of Inhalations of As-needed Medication.|The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.|4 weeks|Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group||Inhalations per day per participant||Full Range|Mean
140638|NCT00463866|Secondary|Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation|Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.|||Days per participant||Standard Deviation|Mean
140639|NCT00463866|Secondary|Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.|A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant|6 months.|||Number of events per participant||Full Range|Mean
140640|NCT00463866|Secondary|Fraction of Participants With Severe Asthma Exacerbation|The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months.|||Fraction of participants with event||95% Confidence Interval|Mean
140641|NCT00463866|Primary|Number of Severe Asthma Exacerbations Per Participant.|Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.|6 months|||Severe exacerbations per participant||Full Range|Mean
140642|NCT00463840|Secondary|Median Overall Survival|This is the time at which 50% of patients are alive from the trial entry .|up to 10 years since the start of the study||||||
140643|NCT00463840|Primary|Resectability After Chemoradiation|This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).|7.5 weeks|Based on intent-to-treat population.||participants|||Number
140644|NCT00463801|Secondary|Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)||at day 14 and follow up day i.e. day 30||||||
140648|NCT00463801|Secondary|Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10|To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|At day 4 and 10||||||
140649|NCT00463801|Secondary|Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria|To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.|At day 4, 7, 10 and 14||||||
140650|NCT00463801|Primary|Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start|Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.|at Day 7 and 14|Intention to treat (ITT) and safety population: all patients who received at least one dose of study medication.||Participants|||Number
140651|NCT00463788|Secondary|Safety- Number of Participants Experiencing Any Adverse Event (AE)|Number of participants experiencing any AE. AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications.|Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010|Safety population included all the participants who received at least 1 dose of study medication (that is cisplatin or cetuximab).||participants|||Number
140652|NCT00463788|Secondary|Time to Response (TTR)|The TTR was determined for participants whose confirmed BOR (based on RECIST) was either a CR or a PR . It was defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR.|Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.||months||95% Confidence Interval|Median
140653|NCT00463788|Secondary|Overall Survival (OS) Time|The OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010|FAS population included all participants who were randomized as described in the pre-assignment details.||months||95% Confidence Interval|Median
140654|NCT00463788|Secondary|Progression-Free Survival (PFS) Time|The PFS was defined as the duration from randomization until radiological progression according to investigator (based on RECIST) or death due to any cause. Only deaths within 85 days of last tumor assessment were considered. Participants without event were censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.||months||95% Confidence Interval|Median
140655|NCT00463788|Primary|Best Overall Response (BOR)|Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009|FAS population included all participants who were randomized as described in the pre-assignment details.||percentage of participants||95% Confidence Interval|Number
140656|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set)|The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140657|NCT00463606|Secondary|Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set)|The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Inter-Quartile Range|Median
140658|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set)|The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140659|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140660|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140661|NCT00463606|Secondary|Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set)|The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140662|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140663|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set)|The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140664|NCT00463606|Primary|Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set)|The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.|Baseline to 12 Weeks|Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.||percent change||Standard Error|Mean
140665|NCT00463580|Secondary|CRP, IL-6, TNF-alpha, TNFR 1 and 2|Investigate the effects of baseline CRP (and IL-6, TNF-alpha, TNFR 1 and 2) on reduction in depressive symptoms in patients in the two treatment groups.|Baseline||||||
140666|NCT00463580|Secondary|Correlation Coefficients Between Changes in HDRS Symptom Score and Changes in Diurnal Slope of Cortisol and ACTH, p.m. Cortisol Plasma Concentrations, Diurnal Plasma Concentrations of Inflammatory Cytokines and Their Receptors and Sleep Efficiency||Measured numerically and as the ratio of change score to baseline score||||||
140667|NCT00463580|Secondary|Between-group Differences (Mean ±SD) in the Change of Cortisol and ACTH Slope, p.m. Cortisol, Diurnal Plasma Cytokine and Cytokine Receptor Concentrations and Sleep Efficiency Between Baseline and Study Week 8.||Between baseline and study week 8.||||||
140668|NCT00463580|Secondary|The Correlation Coefficient Between Changes in HDRS Symptom Score(Measured Numerically and as the Ratio of Change Score to Baseline Score) and Changes in the Plasma Concentrations of TNF-alpha, IL-6 and CRP.||Between baseline and any study point||||||
140669|NCT00463580|Secondary|Between Group Differences in Self-reported Depression Scores Measured by the IDS—SR||At any study point||||||
140670|NCT00463580|Secondary|Between Group Difference in Percentage of Remitted Patients During Treatment (HDRS ≤7 or CGI of 1)||At any study point||||||
140671|NCT00463580|Secondary|Number of Patients With a 50% Reduction in HDRS Scores at Any Study Point||At any study point|||participants|||Number
140672|NCT00463580|Primary|(Study Endpoint): Mean (SD) Hamilton Depression Rating Scale 17-item (HAM-D-17) Scores at Baseline and Each Post Baseline Time Point.|Hamilton Depression Rating Scale-17 item; Minimum score= 0 Maximum score= 54; Higher scores represent greater symptom severity|baseline and treatment weeks 1, 2, 4, 6, 8, 10 and 12|Power calculations were based on standard deviations derived from published literature of HAM-D scores in patients with TRD (60 participants,80% power). An intent-to-treat analysis using mixed-effects model for repeated measures was used to analyze change from baseline of HAM-D scores as a function of treatment, time, and their interaction.||scores on a scale||Standard Deviation|Mean
140685|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the beginning of the study up to the end of the extended 6-month safety follow-up period|||subjects|||Number
140673|NCT00463567|Other Pre-specified|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 14, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for AUC 1h-4h FEV1 at Day 14. Missing data were imputed using last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
140674|NCT00463567|Other Pre-specified|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment|"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates."|Day 15, After 2 Weeks of treatment in Stage 1|Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for Trough FEV1 at Day 15. Missing data were imputed using last observation carried forward (LOCF).||Liters||Standard Error|Least Squares Mean
140675|NCT00463567|Secondary|"The Percentage of Days of Poor Control Reported Over the 26 Week Treatment Period"|"A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of “days of poor control” as well as FEV1 reversibility components as covariates."|up to 26 weeks|Intent to Treat population consisting of all participants in Stage 2 of the study who received at least one dose of study drug. Eligible participants for the analysis were those with ≥7 evaluable diary days in the baseline period and ≥30% evaluable diary days (at least 20 days) in total.||Percentage of days||Standard Error|Least Squares Mean
140676|NCT00463567|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.|after 12 weeks of treatment|Participants from the Intent to Treat Population of Stage 2 of the study who received at least one dose of study drug and for whom data was available for FEV1 at 12 weeks. Imputed with last observation carried forward.||Liters||Standard Error|Least Squares Mean
140677|NCT00463437|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value|Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
140678|NCT00463437|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value|Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
140679|NCT00463437|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value|Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
140680|NCT00463437|Secondary|Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value|Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
140681|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was ≥ 8.~The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
140682|NCT00463437|Secondary|Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).~The cross-reactive pneumococcal serotypes assessed include 6A and 19A."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
140683|NCT00463437|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value|"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8.~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
140684|NCT00463437|Secondary|Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value|"Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL).~The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F."|Before (pre) and one month after (post) the booster administration|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||subjects|||Number
141001|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
140686|NCT00463437|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 31-day (Day 0-30) period after the booster vaccination|||subjects|||Number
140687|NCT00463437|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) period after the booster vaccination|||subjects|||Number
140688|NCT00463437|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.||subjects|||Number
140689|NCT00463437|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day (Day 0-3) period after the booster vaccination|Subjects from the Total Vaccinated cohort for whom data were available.||subjects|||Number
140690|NCT00463437|Primary|Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)|Fever was measured as rectal temperature.|During the 4-day (Day 0-3) period after the booster vaccination|Analysis was performed on the Total vaccinated cohort from Pn-HibC and Pr-HibC Groups on subjects for whom data were available.||subjects|||Number
140691|NCT00463385|Secondary|Number of Participants With Adverse Events (AEs)|"A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above).~The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale:~Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death.~The Investigator determined the relationship between study drug and the occurrence of an AE as “Not Related” or “Related” (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa)."|From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months).|Safety population (all treated patients).||participants|||Number
140692|NCT00463385|Secondary|Percentage of Participants With Clinical Response by Baseline JAK2 Assessment|Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline.|Up to 336 days|Intent-to-treat population with non-missing JAK2 Baseline assessment results. The number of participants analyzed indicates the number of participants with a positive or negative JAK2 result for each treatment group respectively.||percentage of participants|||Number
140693|NCT00463385|Secondary|Change From Baseline in Likert Abdominal Pain Scale|Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable.|Baseline and Cycle 6 (168 days)|Intent-to-treat patients with available data.||units on a scale||Standard Deviation|Mean
140694|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Non-Responders|Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with no clinical response and available hemoglobin values at each time point.||g/dL||Full Range|Median
140695|NCT00463385|Secondary|Change From Baseline in Hemoglobin Concentration for Responders|Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment.|Baseline, Cycle 6 (168 days)|Intent-to-treat participants with a clinical response and available hemoglobin values at each time point.||g/dL||Full Range|Median
140696|NCT00463385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores|"The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.~Physical Well-being consists of 7 questions, the subscale score ranges from 0-28;~Social/Family Well-being consists of 7 questions, the subscale score ranges from 0-28;~Emotion Well-being consists of 6 questions, the subscale score ranges from 0-24;~Functional Well-Being consists of 7 questions, the subscale score ranges from 0-28;~Anemia subscale consists of 20 questions, the subscale score ranges from 0-80;~Total FACT-An score ranges from 0-188."|Baseline and Cycle 6 (168 days).|Intent-to-treat patients with available data.||units on a scale||Standard Deviation|Mean
140697|NCT00463385|Secondary|Duration of First Clinical Response|"For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment.~For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement.~Kaplan-Meier methodology was used."|Up to 40 months|Intent-to-treat population with a clinical response.||months||95% Confidence Interval|Median
140709|NCT00463229|Secondary|Reintegration to Normal Living Index|The RNLI assesses global functional status and measures both the stroke survivors’ perceptions of their own capabilities and objective indicators of physical, social, and psychological performance. The RNLI consists of 11 items which cover the domains of mobility, self-care abilities, daily activities, recreational and social activities, family roles, and personal relationships, presentation of self and general coping skills. Each item is scored as 0 to 2. The individual items sum to provide a total score, with 22 indicating the highest degree of reintegration.|Baseline (pre-randomization) and 12 months||09/2010||||
140698|NCT00463385|Secondary|Time to the First Clinical Response|"The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as:~Start date of the first clinical response – the first study drug date +1.~A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable."|Up to 168 days|Intent-to-treat population with a clinical response||weeks||Full Range|Median
140699|NCT00463385|Secondary|Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment|"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 336 days|Intent-to-treat (ITT), defined as as all patients who were randomized, independent of whether they received study treatment or not.||percentage of participants||95% Confidence Interval|Number
140700|NCT00463385|Primary|Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment|"A clinical responder was defined as either:~A baseline red blood cell (RBC)-transfusion-dependent participant with a ≥ 56 consecutive day RBC transfusion-free period after the first dose of study drug, or~A baseline RBC-transfusion-independent participant with an increase in hemoglobin of 2.0 g/dL or more from baseline for ≥ 56 consecutive days in the absence of RBC transfusions, or~A participant with either a ≥ 50% reduction in palpable splenomegaly of a spleen that was ≥ 10 cm at baseline or a spleen that was palpable at > 5 cm and became not palpable.~Participants who discontinued the study early without achieving clinical response were counted as non-responders."|Up to 168 days|Modified intent-to-treat (MITT), defined as the patients who had a confirmed diagnosis of Myelofibrosis with myeloid metaplasia (MMM), received at least one dose of study drug, and participated in the study for at least 56 days.||percentage of participants||95% Confidence Interval|Number
140701|NCT00463346|Primary|Psychotic Symptoms - Measured Using the PANSS|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms.|12 weeks|||units on a scale||Standard Error|Mean
140702|NCT00463346|Primary|Number of Drinking Days||12 weeks|||days||Standard Deviation|Mean
140703|NCT00463229|Secondary|Kessler - 10|The Kessler-10 assesses level of anxiety and depressive symptoms a person may have experienced in the most recent four-week period. Its main strength is a superior ability to screen for anxiety and affective disorders. Each item is assigned a score ranging from 5 (all of the time) to 1 (none of the time). These 10 items are summed to give scores ranging from 10-50, where 50 indicates high risk of anxiety or depressive disorder. Previous studies have established a cut-off score of 16-29/50 for medium risk, and 30-50/50 as high risk for anxiety and depressive disorders.|Baseline (pre-randomization) and 12 months||09/2010||||
140704|NCT00463229|Secondary|Health and Social Services Utilization Inventory|The costs of use of all types of health services from baseline to 12 months were determined using the Health and Social Services Utilization Inventory (HSSUI), which assesses costs from a societal perspective. The HSSUI consists of questions about the respondent’s use of six categories of direct health care services: (1) primary care; (2) emergency department and specialists; (3) hospital days; (4) seven types of other health and social professionals; (5) medications; and (6) lab services. The product of the number of units of service (quantity) and unit cost (price) is total cost.|Baseline (pre-randomization) and 12 months||09/2010||||
140705|NCT00463229|Secondary|Personal Resource Questionnaire (PRQ85-Part Two)|The PRQ85–Part Two is a 25-item scale that measures perceived social support along five dimensions: provision for attachment/intimacy; social integration; opportunity for nurturing behaviour; reassurance of worth as an individual and in role accomplishments; and the availability of informational, emotional, and material help. The maximum score is 175; a higher score indicates a greater perception of social support.|Baseline (pre-randomization) and 12 months||09/2010||||
140706|NCT00463229|Secondary|Caregiver Reaction Assessment Scale.|The Caregiver Reaction Assessment Scale is a multidimensional, 5-factor measure designed to assess the negative and positive aspects of caregiving. Each item is scored from 1 to 5 from strongly disagree to strongly agree. There are five subscales: (a) esteem, (b) family support, (c) finances, (d) impact on schedule, and (e) impact on health.|Baseline (pre-randomization) and 12 months||09/2010||||
140707|NCT00463229|Secondary|Centre for Epidemiological Studies in Depression Scale (CES-D)|The CES-D scale is a 20-item, self-reported questionnaire that assesses the current frequency of depressive symptoms. Total scores can range from 0 to 60; the higher the score, the more depressed.|10 minutes||11/2009||||
140708|NCT00463229|Secondary|Short Portable Mental Status Questionnaire.|The 10-item Short Portable Mental Status Questionnaire (SPMSQ) is used for the screening, diagnosis and assessment of cognition. The SPMSQ is short, easily administered and has been designed, tested, standardized and validated in a variety of populations, including stroke. The SPMSQ consists of 10 items. The individual items sum to provide a total score; with greater than 4 errors indicating some degree of intellectual impairment.|Baseline (pre-randomization) and 12 months||09/2010||||
141203|NCT00459979|Secondary|Number of Tumors With 30% Reduction in Size|Number of tumors with at least 30% reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol- after at least one cycle of Sunitinib||tumors|Participants||Number
140710|NCT00463229|Secondary|Stroke Impact Scale - 16|The SIS-16 assesses several aspects of health-related quality of life that are important to stroke survivors, caregivers, and healthcare professionals. The SIS-16 consists of 16 items which cover the physical aspects of stroke including: strength, hand function, mobility, and activities of daily living/instrumental activities of daily living. Each item is assigned a score ranging from 1 (could not do at all) to 5 (not difficult at all). The individual items sum to provide a total score, with higher scores indicating higher levels of health-related quality of life and function.|Baseline (pre-randomization) and 12 months||09/2010||||
140711|NCT00463229|Primary|SF-36 Physical Function Score to Measure the Change in Health-related Quality of Life and Function From Baseline (Pre-randomization)to 12 Months.|The primary measure of effect was the change in health-related quality of life and functioning from baseline to 12-months as measured by the SF-36 physical functioning score. The range of possible scores for this subscale is 0-100, with a higher score indicating a more favourable health status.|Baseline (pre-randomization) and 12 months|||Units on a scale||Standard Deviation|Mean
140712|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the Endpoint (time of the last observation during the treatment period)who responded to each option is presented.|Endpoint (End of second double-blind treatment period or last observation after start of treatment period)|Double-blind safety analysis set: 88 subjects who received FBT and 94 subjects who received Oxycodone at any time during the double-blind treatment period who completed the PFTS questionnaire||Participants|||Number
140713|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the second double-blind treatment period (Visit 6) who responded to each option is presented.|At the end of the second double-blind treatment period (Visit 6)|Double-blind safety analysis set: 83 subjects who received FBT and 87 subjects who received Oxycodone in the second double-blind period||Participants|||Number
140714|NCT00463047|Secondary|Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)|The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the first double-blind treatment period (Visit 5) who responded to each option is presented.|The end of the first double-blind treatment period.|Double-blind safety analysis set: 88 subjects who received FBT and 90 subjects who received Oxycodone in the first double-blind period||Participants|||Number
140715|NCT00463047|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients’ preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient’s preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|After completion of both double-blind treatment periods or early termination|Double-blind safety analysis set: 190 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment||Participants|||Number
140716|NCT00463047|Secondary|Medication Performance Assessment 60 Minutes After-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Number of episodes treated|Participants||Number
140717|NCT00463047|Secondary|Medication Performance Assessment 30 Minutes After-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Number of episodes treated|Participants||Number
140762|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment||treatment cycles||Full Range|Median
140718|NCT00463047|Secondary|Standard Rescue Medication Usage|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient’s diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|During the administration of study drug during the double blind treatment periods.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Number of episodes treated|Participants||Number
140719|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 60 minutes was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140720|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 45 minutes was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140721|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140722|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 15 minutes was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140723|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes|The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 10 minutes was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140724|NCT00463047|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes|Time to MPR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment period. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to meaningful pain relief fell into that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
141016|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
140725|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=60 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 60 minutes was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140726|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=45 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 45 minutes was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140727|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=30 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 30 minutes was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140728|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=15 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 15 minutes was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140729|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <=10 Minutes|The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 10 minutes was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140730|NCT00463047|Secondary|Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes|Time to APR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment period. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 5 minutes was compared.|From time was administered to 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.||Number of episodes treated|Participants||Number
140731|NCT00463047|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) times 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Percent change in units on a scale||Standard Deviation|Mean
141069|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.||Week 48|Intent To Treat (ITT), last observation carried forward (LOCF).||cells/mm^3||Full Range|Median
140732|NCT00463047|Secondary|Total Pain Relief (TOTPAR60) at 60 Minutes|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140733|NCT00463047|Secondary|Pain Relief Score (PR) at 60 Minutes|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
140734|NCT00463047|Secondary|Pain Relief Score (PR) at 45 Minutes|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
140735|NCT00463047|Secondary|Pain Relief Score (PR) at 30 Minutes|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
140736|NCT00463047|Secondary|Pain Relief Score (PR) at 15 Minutes|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
140737|NCT00463047|Secondary|Pain Relief Score (PR) at 10 Minutes|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
140738|NCT00463047|Secondary|Pain Relief (PR) Score at 5 Minutes|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient’s diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|Five minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.||Units on a scale||Standard Deviation|Mean
140739|NCT00463047|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140763|NCT00462943|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL||percentage of participants||95% Confidence Interval|Number
140844|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24|ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
140740|NCT00463047|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140741|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 60 minutes divided by the baseline PI score times 100.|Immediately before and 60 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
140742|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 45 minutes divided by the baseline PI score times 100.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on scale||Standard Error|Mean
140743|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100.|Immediately before and 30 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
140744|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100.|Immediately before and 15 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
140745|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percentage change in units on a scale||Standard Error|Mean
140764|NCT00462943|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).~Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed)."|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline||percentage of participants|||Number
140746|NCT00463047|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100.|Immediately before and 5 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Percent change in units on a scale||Standard Error|Mean
140747|NCT00463047|Secondary|Pain Intensity Difference (PID 60) at 60 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 60 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140748|NCT00463047|Secondary|Pain Intensity Difference (PID 45) at 45 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 45 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140749|NCT00463047|Secondary|Pain Intensity Difference (PID 30) at 30 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140750|NCT00463047|Secondary|Pain Intensity Difference (PID 10) at 10 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 10 minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140751|NCT00463047|Secondary|Pain Intensity Difference (PID 5) at 5 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately before and 5 minutes after study drug administration|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140776|NCT00462839|Secondary|Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.||1 hour|||participants|||Number
140777|NCT00462839|Secondary|Level of Training||1 hour|||participants|||Number
140778|NCT00462839|Secondary|Number and Type of Care Providers Assigned to Study Arms.||1 hour|per protocol||participants|||Number
140779|NCT00462839|Primary|Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.|Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.|1 hour|per protocal||milliliters||95% Confidence Interval|Mean
140752|NCT00463047|Primary|Pain Intensity Difference (PID15) At 15 Minutes|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and fifteen minutes after administration of study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.||Units on a scale|Participants|Standard Error|Least Squares Mean
140753|NCT00462982|Primary|Central Nervous System (CNS) Response Rate by RECIST Criteria|Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.|up to a year|||participants|||Number
140754|NCT00462943|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
140755|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
140756|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response||months||Full Range|Median
140757|NCT00462943|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to four years|Intent to treat population of participants who had a response||months||Full Range|Median
140758|NCT00462943|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.~Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 4 years|Intent to treat||participants|||Number
140759|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|Day 1 up to Month 9|Intent to treat population.||months||95% Confidence Interval|Median
140760|NCT00462943|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat population.||months||95% Confidence Interval|Median
140761|NCT00462943|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to Month 9|Intent to treat population of participants who had a cytogenetic response||treatment cycles||Full Range|Median
140780|NCT00462826|Secondary|Duration of Overall Survival||From entry into the study to death or the date of last contact, up to 5 years||||||
140781|NCT00462826|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, up to 5 years||||||
140765|NCT00462943|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)~Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.~Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.~Partial Response - CHR plus one or more of the following:~Persistence of splenomegaly with a reduction of ≥50% from pre-treatment~Platelets > 450*10^9/L~Presence of immature cells in the peripheral blood~5% to 25% blasts in the bone marrow~If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat||percentage of participants|||Number
140766|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
140767|NCT00462943|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
140768|NCT00462943|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:~Complete: 0% Ph+ cells~Partial: >0%-35% Ph+ cells~Minor: >35%-65% Ph+ cells~Minimal: >65%-95% Ph+ cells~No Response: >95% Ph+ cells~Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat||percentage of participants|||Number
140769|NCT00462943|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful. Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 9 months|Intent to treat population||percentage of participants||95% Confidence Interval|Number
140770|NCT00462943|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population||percentage of participants||95% Confidence Interval|Number
140771|NCT00462917|Secondary|Impact of Events Scale (IES)|A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."||units on a scale||Standard Deviation|Mean
140772|NCT00462917|Primary|Beck Anxiety Inventory (BAI)|A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.|6 weeks, 6 months, 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."||units on a scale||Standard Deviation|Mean
140773|NCT00462917|Primary|Center for Epidemiological Studies-Depression Scale (CES-D)|A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.|6 weeks, 6 months, and 12 months post-disclosure|"Number of participants analyzed are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data."||units on a scale||Standard Deviation|Mean
140774|NCT00462865|Secondary|To Monitor the Rate of Recurrent Disease, Either Local This Population.||6 months and again at the end of the study (1 year)||||||
140775|NCT00462865|Primary|Toxicity Issues of Administering 6 Cycles of Gemcitabine, Capecitabine, and Avastin and One Year of Consolidation of Avastin in Women With Breast Cancer Previously Treated With Neoadjuvant Chemotherapy That Lead to Patients Being Taken Off Study.|6 out of 17 patients came off study for toxicity prior to receiving all treatment.|1 year|||participants|||Number
140785|NCT00462748|Primary|Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End|Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end.|6 Weeks|"The Full Analysis Set (FAS) all patients who were:~Randomised~Took at least one dose of double-blind medication~Had a baseline measurement of efficacy~Had a post-baseline measurement of efficacy~Patients were analysed according to the treatment group they were randomised, regardless of the treatment they received"||Percent|||Number
140786|NCT00462722|Secondary|Expression of Selected Proteins and Genes Associated With Muscle Build-up and Breakdown||Baseline and after 9 months of training|Because of the costs associated with gene and protein expression techniques and data reduction, we did not pursue this secondary outcome after learning the results of the primary outcome (change in fat-free mass).|||||
140787|NCT00462722|Secondary|Bone Turnover Markers||Baseline, and after 4.5 & 9 months of training|Because of the costs associated with the assays and data analysis of bone turnover markers, we did not pursue data collection after learning of the primary outcomes (changes in BMD).|||||
140788|NCT00462722|Secondary|Change in Thigh Cross-sectional Muscle Area||Baseline and after 9 months of training|Because of the costs associated with data analysis for this secondary outcome, we did not pursue the analysis after learning the results of the primary outcome (fat-free mass).|||||
140789|NCT00462722|Secondary|Percentage Change From Baseline in Sub-trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise groups had uninterpretable hip scans."||percentage change in BMD||Standard Deviation|Mean
140790|NCT00462722|Secondary|Percentage Change From Baseline in Trochanter Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|||percentage change in BMD||Standard Deviation|Mean
140791|NCT00462722|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable spine scans."||percentage change in BMD||Standard Deviation|Mean
140792|NCT00462722|Primary|Change From Baseline in Fat-free Mass at 9 Months||Baseline and after 9 months of training|||change in kg||Standard Deviation|Mean
140793|NCT00462722|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Placebo pre and post exercise group and two participants in the Ibuprofen pre and placebo post exercise group had uninterpretable hip scans."||percentage change in total hip BMD||Standard Deviation|Mean
140794|NCT00462722|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 9 Months||Baseline and after 9 months of training|"One participant in the Ibuprofen pre and placebo post exercise group had an uninterpretable spine scan."||Percentage change in lumbar spine BMD||Standard Deviation|Mean
140795|NCT00462709|Other Pre-specified|Complement C4 Serum Levels|Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=134).||mg/dL||Standard Deviation|Mean
140796|NCT00462709|Other Pre-specified|Functional C1INH Serum Levels|"Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=132).||percent||Standard Deviation|Mean
140797|NCT00462709|Other Pre-specified|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=137).||mg/dL||Standard Deviation|Mean
140798|NCT00462709|Primary|Frequency of All HAE Attacks|A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.|Duration of the study|Intent-to-treat Efficacy (ITT-E) Population (N=146; the number of subjects who received at least one prophylactic dose of C1INH-nf for the prevention of HAE attacks). HAE attack frequency was reported by 137 subjects at screening (i.e., data were missing for 9 subjects).||attacks per month||Full Range|Median
140799|NCT00462670|Secondary|Body Weight (Percent Change)|Percent change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration|||percentage of body weight (Kg)||Standard Deviation|Mean
140800|NCT00462670|Primary|Body Weight (Amount of Change)|Change in body weight from baseline at the time of final trial drug administration|baseline, Day 7 or at the time of final trial drug administration|||Kg||Standard Deviation|Mean
140801|NCT00462644|Secondary|Number of Deaths|deaths|death in hospital|||participants|||Number
140802|NCT00462644|Primary|Cortisol Level 60 Minutes After Cortisol Stimulating Test (CST)||60 minutes after administration of cotrosyn|||micrograms/dL||Standard Deviation|Mean
140803|NCT00462644|Primary|Change in Baseline Cortisol|change from baseline cortisol (drawn prior to RSI) to 2nd cortisol level (4-6hrs after RSI, but before stim test)|4-6hr after RSI|||micrograms/dL||Standard Deviation|Mean
140804|NCT00462644|Primary|Postintubation Cortisol (Baseline Cortisol Level)|cortisol level after randomization and rapid sequence induction|postintubation (baseline cortisol level)|||micrograms/dL||Standard Deviation|Mean
140805|NCT00462644|Secondary|Ventilator Days||time from intubation to extubation|||days||Standard Deviation|Mean
140806|NCT00462644|Secondary|Intensive Care Unit (ICU) Length of Stay|ICU length of stay in days|time from hospital admission to transfer out of ICU to floor bed|||days||Standard Deviation|Mean
140807|NCT00462644|Secondary|Hospital Length of Stay|days from admission to hospital discharge|time to hospital discharge in days|||days||Standard Deviation|Mean
140808|NCT00462644|Primary|Cortisol Levels Pre and Post Rapid Sequence Induction and Cortisol Stimulation Test||pre RSI, 4-6 hours post RSI, and again 60 mins later following ACTH stimulation test||||||
140809|NCT00462501|Primary|Complete Pathologic Response|This will be assessed on the basis of the surgical pathology report.|3 years|||participants|||Number
140810|NCT00462462|Secondary|Patient Benefit||study end||||||
140811|NCT00462462|Secondary|Change in Volume of Congenital Venous Malformation (CVM) From Screening to Study End (Day 112 Visit).||Screening and study end (Day 112)|||cm3||Standard Deviation|Mean
140813|NCT00462462|Primary|Systemic Exposure to Ethanol With the Two Test Products: Determination of the Maximum Plasma Concentration (Cmax)|Blood samples were performed, just before infusion, then 5 min, 10 min, 20 min, 40 min, 60 min, 90 min, and 120 min after infusion at the first site, then every 60 min onwards until ethanol levels are found under the detection limit. Cmax was estimated directly from experimental data. If all the ethanol concentrations of a patient was below the limit of quantification of the laboratory (LOQ), Cmax was reported as LOQ/2 for this patient.|Baseline visit (just before and during test product infusion procedure)|||g/L||Full Range|Mean
140814|NCT00462449|Secondary|Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)|upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol||units on a scale||95% Confidence Interval|Mean
140815|NCT00462449|Secondary|Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)|Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)|12 weeks|Per protocol.||units on a scale||95% Confidence Interval|Mean
140816|NCT00462449|Primary|Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)|upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.|12 weeks|Per protocol. Number was determined based on the number of participants enrolled and eligible.||units on a scale||95% Confidence Interval|Mean
140817|NCT00462423|Secondary|Safety and Tolerability of This Combination|See adverse events Table|April 2007 through December 2010||||||
140818|NCT00462423|Secondary|Objective Response Rate (RR) in Patients With Measurable Lesions Time to Objective Response|The objective response rate is defined as the percentage of patients showing complete or partial response.|The median duration of follow-up for surviving patients was 41.6 months.|||Percentage of participants||95% Confidence Interval|Number
140819|NCT00462423|Secondary|Overall Survival (OS)|The duration of overall survival was defined as the number of months between the start date of protocol treatment and the date of death (irrespective of cause), and was right-censored at the date of last contact for patients who were alive as of the data cutoff.|April 2007 through December 2010|||months||95% Confidence Interval|Median
140820|NCT00462423|Secondary|Progression-free Survival|Median time of progression-free survival from first treatment according to RECIST 1.0|From start of treatment to disease progressin; median duration of follow-up for surviving patients was 41.6 months.|||Months||95% Confidence Interval|Median
140821|NCT00462423|Primary|Progression-free Survival (PFS) at 4 Months|Progression-free survival at 4 months from first treatment as determined by RECIST 1.0|4 months.|||percentage of patients||95% Confidence Interval|Number
140822|NCT00462384|Secondary|Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.|EEP (Weeks 29 to 36)|ITT population||days||Standard Deviation|Mean
140823|NCT00462384|Secondary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.|EEP (Weeks 29 to 36)|ITT population||percentage of participants|||Number
140824|NCT00462384|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP|EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.|EEP (Weeks 29 to 36)|ITT population||percentage of participants|||Number
140825|NCT00462384|Secondary|Time to Achievement of Response|Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.|Baseline to Week 40|ITT population||days||Standard Deviation|Mean
140826|NCT00462384|Primary|Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)|The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.|Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)|Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available.||grams per deciliter (g/dL)||Standard Deviation|Mean
140827|NCT00462345|Secondary|Modified Sharp Radiographic Joint Space Narrowing Score (JSN)|JSN Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total scores for JSN in the hands was 100 and in the feet was 48, for a maximum overall score of 148. Total JSN was for both hands and feet.|Screening, Weeks 24 and 48|ITT population. 39 participants were analyzed for this outcome measure.||scores on a scale||Standard Deviation|Mean
140828|NCT00462345|Secondary|Modified Sharp Radiographic Erosion Score (ES)|Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Maximum total erosion score in the hands was 100 and in the feet was 42, for a maximum overall score of 142. Total erosion score was for both hands and feet.|Screening, Weeks 24 and 48|ITT population||scores on a scale||Standard Deviation|Mean
140829|NCT00462345|Secondary|Modified Total Sharp-Genant Score (mTSS)|Posterior-anterior (PA) radiograph of each hand and anterior-posterior (AP) radiograph of each foot were taken separately and assessed according to Genant’s method as modified from Sharp’s method. The Sharp-Genant score=total of the erosion score and the joint space narrowing (JSN) score of all the hands and feet. Erosion Score: 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. JSN Score:13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total erosion score in hands=100 and in feet=42; maximum scores for JSN in the hands=100 and in feet=48. Maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. Change in scores was calculated as change=final score minus initial score.|Screening and Weeks 24 and 48|ITT population||scores on a scale||Standard Deviation|Mean
140830|NCT00462345|Secondary|SF-36 Mental Component Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n=number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
140831|NCT00462345|Secondary|Physical Function as Assessed by Short Form 36 (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Screening, Weeks 24 and 48|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.||scores on a scale||Standard Deviation|Mean
140832|NCT00462345|Secondary|HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 24 and 48|ITT population||scores on a scale||Standard Deviation|Mean
140833|NCT00462345|Secondary|Erythrocyte Sedimentation Rate (ESR)|The mean level of ESR (in mm/hr), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population||mm/hr||Standard Deviation|Mean
140834|NCT00462345|Secondary|C-reactive Protein (CRP) Level|The mean level of CRP in milligrams per liter (mg/L), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT population||mg/L||Standard Deviation|Mean
140835|NCT00462345|Secondary|Patient Assessment of Pain (VAS)|The mean score of pain at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100-mm horizontal VAS, where the left endpoint indicated “No pain,” and the right endpoint indicated “Unbearable pain.” A negative change indicated improvement.|Baseline, Weeks 24 and 48|ITT population||mm||Standard Deviation|Mean
140836|NCT00462345|Secondary|Physician Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of RA at Week 0 and the change from Week 0 (baseline) to Weeks 24 and 48 as assessed by investigators using a 100-mm horizontal VAS, where the left endpoint indicated No disease activity” (no symptom, or no symptom of RA), and the right endpoint indicated “Maximum disease activity” (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population||mm||Standard Deviation|Mean
140837|NCT00462345|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The mean score of the symptoms of rheumatoid arthritis (RA) at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100 mm horizontal VAS, where the left endpoint indicated No disease activity” (no symptom, or no symptom of RA), and the right endpoint indicated “Maximum disease activity” (maximum RA activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24 and 48|ITT population||mm||Standard Deviation|Mean
140838|NCT00462345|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examination of 68 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of tender joints was recorded on the joint assessment form at each visit as either tender or not tender.|Baseline, Weeks 24 and 48|ITT population||tender joints||Standard Deviation|Mean
140839|NCT00462345|Secondary|Swollen Join Count (SJC)|Number of swollen joints was determined by examination of 66 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit as swollen or not swollen.|Baseline, Weeks 24 and 48|ITT population||swollen joints||Standard Deviation|Mean
140840|NCT00462345|Secondary|Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24|The percentage of participants categorized as good, moderate, or nonresponders according to the EULAR response criteria at Week 24. Participants were categorized as good responders if the intensity of their symptoms was in the “low disease activity (DAS28 less than [<]3.2)” category after treatment, and their symptoms significantly decreased to >1.2. Participants were categorized as moderate responders if the intensity of their symptoms was in the “moderate or high disease activity (DAS28 >3.2)” category after treatment, and the symptoms significantly decreased to >1.2; or if the intensity of their symptoms was in the “low or moderate disease activity (DAS28 <5.1)” category, and the DAS28 score changed more than 0.6 or 1.2 or less. Participants were categorized as non-responders if they did not fall into the good or moderate categories.|Week 24|ITT population||percentage of participants|||Number
140841|NCT00462345|Secondary|Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity.|Baseline, Week 24|ITT population||percentage of participants|||Number
140842|NCT00462345|Secondary|Disease Activity Score Based on 28-Joint Count (DAS-28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hr]) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT population||scores on a scale||Standard Deviation|Mean
140843|NCT00462345|Secondary|Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24|ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
140963|NCT00461708|Secondary|Number of Participants Who Died During the Study By Rash Grade||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population||participants|||Number
140845|NCT00462345|Primary|Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24|ACR20 response: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|Week 24|ITT population||percentage of participants||95% Confidence Interval|Number
140846|NCT00462332|Secondary|Disease-free Survival||At 2 years from study entry||||||
140847|NCT00462332|Secondary|Event-free Survival||At 2 years from study entry||||||
140848|NCT00462332|Secondary|Length of Survival||At 2 years and a half from study entry|||years||Standard Deviation|Mean
140849|NCT00462332|Secondary|Toxicity|Number of AEs and SAEs|At 2 years from study entry||||||
140850|NCT00462332|Primary|Number of Patients With Complete Response|"Normal clinical or X-ray examination (lymph nodes, liver, spleen)~No symptoms~Lymphocytes higher or equal to 4.0 per 10^9/L~Neutrophils lower or equal to 1.5 per 10^9/L~Platelets >100 per 10^9/L~Hb >11.0 g/dL~Bone marrow lymphs according to age, lymphocytes <30%, no nodules."|At 2 years from study entry|||participants|||Number
140851|NCT00462306|Secondary|Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires|Number of subjects with obstetrician diagnosis of pregnancy induced hypertension (pre-eclampsia) among subjects with a positive compared to a negative Berlin questionnaire. The Berlin Questionnaire consists of three categories. Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a Positive Berlin Questionnaire if 2 or more categories are positive.|1-2minutes|Analysis per protocol||participants|||Number
140852|NCT00462306|Primary|Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing|The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.|1-2 minutes|Pregnant Women presenting to Prentice Women's Hospital or non-pregnant women or childbearing age presenting for ambulatory surgery from 10/2005 to 9/2007 were selected randomly and asked to complete the survey.||participants|||Number
140853|NCT00462280|Secondary|At Least 1 Study-related Adverse Event Reported During the Study|All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.|Baseline up to 26 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm."||participants|||Number
140854|NCT00462280|Secondary|Change in C-reactive Protein (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
140855|NCT00462280|Secondary|Change in CPK (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||U/L||95% Confidence Interval|Mean
140856|NCT00462280|Secondary|Change in SGOT/ALT (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||U/L||95% Confidence Interval|Mean
140857|NCT00462280|Secondary|Change in SGOT/AST (U/L) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||U/L||95% Confidence Interval|Mean
140858|NCT00462280|Secondary|Change in Triglycerides (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
140859|NCT00462280|Secondary|Change in HDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
140860|NCT00462280|Secondary|Change in LDL (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
140861|NCT00462280|Secondary|Change in Cholesterol (mg/dL) From Baseline After Treatment||Baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||mg/dL||95% Confidence Interval|Mean
140862|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140863|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140864|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140865|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140866|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140867|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140868|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140869|NCT00462280|Secondary|Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation|Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140870|NCT00462280|Secondary|Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation|p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140871|NCT00462280|Secondary|Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation|RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140872|NCT00462280|Secondary|Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation|VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
141867|NCT00454181|Primary|Change in Total Oral Mucosal Area Covered by Warts.|Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area|24 weeks, from baseline to the end of treatment|Per protocol||participants|||Number
140873|NCT00462280|Secondary|Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation|(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140874|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.||score||Standard Deviation|Mean
140875|NCT00462280|Secondary|Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation|(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140876|NCT00462280|Secondary|Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation|HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||percentage of cells that are positive||95% Confidence Interval|Mean
140877|NCT00462280|Secondary|Total Nevus Number on Patient’s Back - Combined Three Reviewers' Evaluations|Assessed by photos of subjects’ back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||pairs of photos|||Number
140878|NCT00462280|Secondary|Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations|From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin.|From baseline up to 24 weeks|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. The total number of participants who have complete data are analyzed in this outcome measure."||score||Standard Deviation|Mean
140879|NCT00462280|Primary|Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation|The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.|From baseline up to 24 weeks|Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.||score||Standard Deviation|Mean
140880|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT) Oral Score.|SDMT Oral Score: SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT oral scores.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
140964|NCT00461708|Secondary|OS At 6 Months|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
140881|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Symbol Digit Modality Test (SDMT)Written Score.|SDMT Written Scores. SDMT requires the subject to substitute a number for its corresponding geometric figure. There are nine figures. On the record form, there are a series of rows containing geometric figures in the top half, but the bottom half is left blank. When it is clear that the subject understands the task, he or she is told to fill in the remaining boxes as quickly as possible, completing one box at a time, one row at a time, before proceeding to the next. Skipping from box to box with the same geometric figure is not permitted. Subjects receive one point for each correctly completed box. The total score is the total number of correctly completed boxes in the time allowed. The practice items are not counted in the scoring. The test can be administered by having the subject write out the correct response or by having the subject report the correct answer (i.e., number) aloud. Higher scores are better scores and the range of scores can be from 0 to 110 for SDMT written scores.|baseline, 6 weeks, 12 weeks|All subjects completing the study.||units on a scale||Standard Deviation|Mean
140882|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Delayed Recall Score.|"BVMT-R Delayed recall. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations.~After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.~These scores are for the delayed recall raw score which ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
140883|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Brief VisuoSpatial Memory Test Revised (BVMT-R) Total Recall Score.|"BVMT-R total recall score. Each of the six equivalent, alternate BVMT-R stimulus forms consists of six geometric figures, printed in a 2 x 3 array, on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for 10 seconds, then is asked to draw as many of the figures as possible, in their correct page locations. The total recall score is the sum of the three learning trials.~After a 25-minute delay, which includes primarily verbal activities, the task is repeated. The respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the 6 geometric figures on the original Recall Stimulus page.~These scores are for the total recall raw score which ranges from 0-36 with 36 being the highest and best possible score."|Baseline, 6 weeks, 12 weeks after beginning Namenda or placebo|All subjects who completed the study.||units on a scale||Standard Deviation|Mean
140884|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part B.|Trail Making Test Part B consists of 24 circles on a piece of paper, but rather than all of the circles containing numbers, half of the circles have the numbers 1-12 in them and the other half (12) contain the letters A-L. The person taking the test has the more difficult task of drawing a line from one circle to the next in ascending order; however, he must alternate the circles with numbers in them (1-13) with circles with letters in them (A-L). In other words, he is to connect the circles in order like this: 1-A-2-B-3-C-4-D-5-E and so on. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded.|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||seconds||Standard Deviation|Mean
140885|NCT00462228|Secondary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Trail Making Test Part A.|Trail Making Test Part A consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in the circles. The test taker’s task is to start with number one and draw a line from that circle to the circle with the number two in it to the circle with the three in it, etc. The person continues to connect the circles in numerical order until they reach number 25. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part A. This is a timed test and the number of seconds to complete the task is recorded.|baseline, 6 weeks, 12 weeks|||seconds||Standard Deviation|Mean
140886|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Delayed Recall Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.~The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall raw score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.~These scores are for the delayed recall learning raw score. The HVLT-R delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
140887|NCT00462228|Primary|Improvements From Baseline Scores After 6 and 12 Weeks of Memantine Compared to Placebo on the Hopkins Verbal Learning Test Revised (HVLT-R) Total Recall Learning Scores.|"HVLT-R Learning Scores provide a brief assessment of immediate recall, delayed recall and delayed recognition. It is administered by reading the words aloud, then asking the client to verbally repeat the list of words (immediately; then after a delay), and identify the words from a word list that is presented verbally.~The HVLT-R is easy to administer and score, and is well-tolerated by even significantly-impaired individuals. Tasks include three learning trials, which, when combined produce a total recall score; a delayed recall (25-30 minute delay) trial, and a yes/no delayed recognition trial. Raw scores are derived for Total Recall, Delayed Recall, Retention (percent retained) and a Recognition Discrimination Index.~These results are for the HVLT-R total recall raw learning score. The HVLT-R total recall raw learning score ranges from 0 to 36 with 36 being the highest and best possible score."|Baseline, 6 weeks, and 12 weeks after beginning memantine or placebo|All subjects completing the study.||units on a scale||Standard Deviation|Mean
140888|NCT00462072|Primary|Psoriasis Area and Severity Index (PASI) Delta|The PASI Delta for Ps subjects is a measure used to determine the change in the severity of an individual's disease with a positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 PASI Delta is determined by calculating the average change between the wk 0 and wk 10 PASI.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg||Index Delta||Standard Deviation|Mean
140889|NCT00462072|Primary|Baseline (Wk 10) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 PASI is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks.|Week 10|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg||Index||Standard Deviation|Mean
140890|NCT00462072|Primary|Baseline (Wk 0) Psoriasis Area and Severity Index (PASI)|A PASI score for Ps subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline PASI is an average of the study populations baseline disease activity score prior to the administration of infliximab (remicade). While higher PASI scores indicate more severe psoriasis, it is difficult for subjects or doctors to describe the clinical severity for any specific PASI number.|Baseline (Wk 0)|PASI formula PASI = 0.1 * (erythemahead + indurationhead + desquamationhead) * Area Scorehead + 0.2 * (erythemaarm + indurationarm + desquamationarm) * Area Scorearm + 0.3 * (erythematorso + indurationtorso + desquamationtorso) * Area Scoretorso + 0.4 * (erythemaleg + indurationleg + desquamationleg) * Area Scoreleg||Index||Standard Deviation|Mean
140891|NCT00462072|Primary|Disease Activity Score (DAS28) Delta|The DAS28 Delta for RA and PsA subjects is measure used to determine the change in the severity of an individual's disease with positive delta indicating an improvement in the severity of subject's disease and a negative delta indicating a worsening of a subject's disease. The delta score is used to monitor treatment. The week 10 DAS28 Delta is determined by calculating the average change between the wk 0 and wk 10 DAS28.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]||Score Delta||Standard Deviation|Mean
140892|NCT00462072|Primary|Week 10 Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The week 10 DAS28 is an average of the study population's week 10 disease activity score after taking infliximab (remicade) for 10 weeks. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Week 10|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]||Score||Standard Deviation|Mean
140893|NCT00462072|Primary|Baseline (Wk 0) Disease Activity Score (DAS28)|The DAS28 for RA and PsA subjects is an outcome measure used in determining the severity of an individual's disease. This score is used to assess disease activity and to make and monitor treatment decisions. The baseline DAS28 is an average of the study populations baseline disease activity score prior to the administration of Infliximab (remicade). A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A subject is considered to be in remission if they have a DAS28 lower than 2.6.|Baseline (Wk 0)|Participant data analyzed per protocol using the following DAS28 formula [(=0.56*SQRT(Tender Joint Count)+0.28*SQRT(Swollen Joint Count)+0.36*LN(CRP(mg/L)+1)+0.014*(Visual Analogue Scale+0.96 ]||Score||Standard Deviation|Mean
140894|NCT00462020|Secondary|Length of Stay, Charges, Adverse Events||1 month||||||
140895|NCT00462020|Primary|Abscess After Appendectomy||1 month|||number of patients|||Number
140896|NCT00461981|Primary|Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects|Distribution of IFN-alpha/beta gene signature scores at 7 to 10 days after Dose 1. IFN alpha/beta gene signature scores were calculated as the average fold change in a panel of 21 type 1 IFN-inducible genes. The distribution of IFN alpha/beta gene signature scores ranged from -4 to 4, with -4 representing the lowest level of activity and 4 representing the highest level of activity. The percentage of subjects by IFN-alpha/beta gene signature score for each treatment group were compared.|Post Dose 1 (28 to 42 days post Dose 1)|||Units on a scale|||Number
140897|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 35 days after Dose 2. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 35 days after Dose 2|Post Dose 2 (28 to 35 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and any post-Dose T-cell Elispot results (n=3; n=6)||SPC/2 x 10^5 PBMCs||Full Range|Median
140898|NCT00461981|Primary|Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay Following the First Dose|Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 42 days after Dose 1. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein [FLU]) after adjusting plate background response at 28 to 42 days after Dose 1|Post Dose 1 (28 to 42 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and post-Dose 1 T-cell Elispot results (n=12; n=15)||SPC/2 x 10^5 PBMCs||Full Range|Median
140899|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 2|Post Dose 2 (7 to 10 days post Dose 2)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=10; n=9).||Counts of ASCs per 10^6 PBMCs||Full Range|Median
140900|NCT00461981|Primary|Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay|Counts of antibody secreting cells (ASCs) per 10^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein [FLU] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 1|Post Dose 1 (7 to 10 days post Dose 1)|Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=16; n=17).||Counts of ASCs per 10^6 PBMCs||Full Range|Median
140901|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).||Titer||95% Confidence Interval|Geometric Mean
140902|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).||Titer||95% Confidence Interval|Geometric Mean
140903|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).||Titer||95% Confidence Interval|Geometric Mean
140904|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).||Titer||95% Confidence Interval|Geometric Mean
140905|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).||Titer||95% Confidence Interval|Geometric Mean
140906|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).||Titer||95% Confidence Interval|Geometric Mean
140907|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).||Titer||95% Confidence Interval|Geometric Mean
140908|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).||Titer||95% Confidence Interval|Geometric Mean
140909|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).||Titer||95% Confidence Interval|Geometric Mean
140910|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).||Titer||95% Confidence Interval|Geometric Mean
140911|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).||Titer||95% Confidence Interval|Geometric Mean
140912|NCT00461981|Primary|Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).||Titer||95% Confidence Interval|Geometric Mean
140913|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).||Percentage of Participants|||Number
140914|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).||Percentage of Participants|||Number
140915|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).||Percentage of Participants|||Number
140965|NCT00461708|Secondary|Number of Participants Who Died at 6 Months||Enrollment through Cycle 6 (4-week cycles), up to 6 months.|ITT population||participants|||Number
140966|NCT00461708|Primary|Overall Survival (OS) During the Study|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
140916|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).||Percentage of Participants|||Number
140917|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).||Percentage of Participants|||Number
140918|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).||Percentage of Participants|||Number
140919|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).||Percentage of Participants|||Number
140920|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).||Percentage of Participants|||Number
140921|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).||Percentage of Participants|||Number
140922|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).||Percentage of Participants|||Number
140923|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).||Percentage of Participants|||Number
140967|NCT00461708|Primary|Number of Participants Who Died During the Study||Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population||participants|||Number
140968|NCT00461630|Secondary|Mortality|All-cause mortality|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
140969|NCT00461630|Secondary|Coronary or Non-coronary Revascularisation||During scheduled treatment period (median duration 3.9 years)|||participants|||Number
140970|NCT00461630|Secondary|Stroke|Fatal or non-fatal|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
140924|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).||Percentage of Participants|||Number
140925|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).||Titer||95% Confidence Interval|Geometric Mean
140926|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).||Titer||95% Confidence Interval|Geometric Mean
140927|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).||Titer||95% Confidence Interval|Geometric Mean
140928|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29)||Titer||95% Confidence Interval|Geometric Mean
140929|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).||Titer||95% Confidence Interval|Geometric Mean
140930|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).||Titer||95% Confidence Interval|Geometric Mean
140931|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).||Titer||95% Confidence Interval|Geometric Mean
140971|NCT00461630|Secondary|Major Coronary Events|Non-fatal myocardial infarction (MI) or coronary death|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
140972|NCT00461630|Primary|Major Vascular Event|Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation|During scheduled treatment period (median duration 3.9 years)|||participants|||Number
150888|NCT00380250|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
140932|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).||Titer||95% Confidence Interval|Geometric Mean
140933|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).||Titer||95% Confidence Interval|Geometric Mean
140934|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).||Titer||95% Confidence Interval|Geometric Mean
140935|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2)for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).||Titer||95% Confidence Interval|Geometric Mean
140936|NCT00461981|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).||Titer||95% Confidence Interval|Geometric Mean
140937|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).||Percentage of Participants|||Number
140938|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).||Percentage of Participants|||Number
140939|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).||Percentage of Participants|||Number
140973|NCT00461513|Secondary|Hospitalization and Mortality, Depressive Symptoms, Patients' Self-efficacy in Management of CHF, Adherence to Prescribed Medications, Patient Satisfaction, Proportion of Patients With Guideline-concordant Care, Cost-effectiveness of the Intervention.||12 months||||||
141204|NCT00459979|Secondary|Number of Tumors Which Decreased in Size|Number of tumors with at least some reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - after at lease one cycle of Sunitinib||tumors|Participants||Number
140940|NCT00461981|Primary|Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29).||Percentage of Participants|||Number
140941|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).||Percentage of Participants|||Number
140942|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).||Percentage of Participants|||Number
140943|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).||Percentage of Participants|||Number
140944|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).||Percentage of Participants|||Number
140945|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).||Percentage of Participants|||Number
140946|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).||Percentage of Participants|||Number
140947|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 2 (28 to 35 days post Dose 2)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).||Percentage of Participants|||Number
140974|NCT00461513|Primary|Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.|The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvment in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.|12 months|||units on a scale||Standard Deviation|Mean
140948|NCT00461981|Primary|Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain|The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain|Post Dose 1 (28 to 42 days post Dose 1)|The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).||Percentage of Participants|||Number
140949|NCT00461851|Secondary|To Define the Proportion of Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Bladder That Achieve a Complete or Partial Response to the Combination Therapy With Sorafenib, Gemcitabine, and Carboplatin.||Upon completion of study||12/2016||||
140950|NCT00461851|Secondary|To Determine the Overall Safety and Tolerability of Combination Therapy With Sorafenib, Gemcitabine and Carboplatin||Upon completion of study||12/2016||||
140951|NCT00461851|Primary|To Evaluate the Time to Disease Progression in Patients With Advanced/Metastatic TCC Treated With the Combination of Sorafenib, Gemcitabine, and Carboplatin.||Upon completion of study|||months||95% Confidence Interval|Median
140952|NCT00461786|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause up to 5-year follow-up|||months||Full Range|Median
140953|NCT00461786|Secondary|Progression-Free Survival|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|baseline until documented tumor progression (up to 44 months)|||months||Full Range|Median
140954|NCT00461786|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 44 months)|||months||Full Range|Median
140955|NCT00461786|Secondary|Number of Participants With Adverse Events by Grade|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle up to 5 year follow-up|||participants|||Number
140956|NCT00461786|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 44 months)|||participants|||Number
140957|NCT00460993|Primary|Sleep Efficiency|Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time|6 days|||percentage of sleep||Full Range|Median
140958|NCT00461708|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population||percentage of participants|||Number
140959|NCT00461708|Secondary|Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST|As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population||percentage of participants|||Number
140960|NCT00461708|Secondary|PFS|The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months|ITT population; only participants with an event (death or disease progression) were included in the analysis.||months||95% Confidence Interval|Median
140961|NCT00461708|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.|Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.|ITT population||participants|||Number
140962|NCT00461708|Secondary|OS By Rash Grade|OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.|Enrollment through Cycle 24 (4-week cycles), up to 24 months.|ITT population; only participants who died were included in the analysis.||months||95% Confidence Interval|Median
140975|NCT00461500|Secondary|Change From Baseline in Overall Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|7-point scale where 1=total impairment and 7=no impairment. Questions contain 32 items in four domains. Domains include Activity Limitation (11 items), Symptoms (12 items), Emotional Function (5 items), and Environmental Stimuli (4 items). 32 items produce one overall quality of life score. The 7 points scoring are different and depend on the item : they are the translation in French of the original questionnaire from Juniper. Possible AQLQ scores range from 1 to 7 (the mean of all the questions).|Baseline, Week 12|Intent-to-Treat population.||Score on a scale||Standard Deviation|Mean
140976|NCT00461500|Secondary|ACT Score in Classes at Week 12|Score is ranged from 5 (poor control) to 25 (complete control).|Week 12|Intent-to-Treat population.||Particpants|||Number
140977|NCT00461500|Secondary|Change From Baseline in Asthma Control Test (ACT) Score at Week 12|5 question test with various responses rating frequency of asthma events over 4-week period. Questions include occurrence of asthma affecting work/school; causing shortness of breath; symptoms (wheezing, coughing, shortness of breath, chest tightness, pain) wake you up at night; causing need for rescue medication; asthma control. Scale: 1=all of time, 2=most of time, 3=some of the time, 4=a little of the time, 5=none of the time. Possible ACT scores range from 5 to 25.|Baseline, Week 12|Intent-to-Treat population.||Score on a scale||Standard Deviation|Mean
140978|NCT00461500|Secondary|Number of Participants Who Achieved Total-controlled Asthma During Weeks 5-12|"Totally-controlled asthma is defined as no daily symptoms, no night-time awakenings, no exacerbations, no rescue medication, no emergency visits, no treatment related adverse events resulting in change in asthma therapy, >=80% predicted PEF. The number of subjects who achieved total-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.||Participants|||Number
140979|NCT00461500|Secondary|Median Number of Weeks to First Achieve Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The median number of weeks to first achieve well-controlled asthma during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 - 12|Intent-to-Treat population.||Weeks||Full Range|Median
140980|NCT00461500|Secondary|Number of Participants Who Achieved Well-Controlled Asthma During Weeks 5-12|"Well-controlled asthma is defined as 2 or more of the following: symptoms on no more than 2 days with symptom score of >1; no more than 2 days of rescue meds (maximum of 4 per week); >=80% predicted morning PEF. And no night time awakenings, exacerbations, emergency room visits, and treatment related adverse effects requiring a change to therapy. The number of participants who achieved well-controlled asthma at any time during Week 5-12 of the study period will be summarized by treatment groups. The difference between treatment groups will be assessed using logistic regression."|Weeks 5 -12|Intent-to-Treat population.||Participants|||Number
140981|NCT00461500|Secondary|Number of Participants With at Least One Exacerbation During 12-Week Treatment Period|Subjects will record exacerbations (defined as temporary PEF decrease, increase in salbutamol use) in a Daily Record Card (DRC). The number of events are categorized as those that showed a deterioration in asthma requiring administration of oral corticosteroids and/or a deterioration in asthma requiring emergency room visit and/or hospitalization (hosp.).|12-Week Treatment Period (Week 1 through Week 12)|Intent-to-Treat population.||Participants|||Number
140982|NCT00461500|Secondary|Change From Baseline (BL) in Pre-dose FEF 25-75% (Forced Expiratory Flow) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Forced Expiratory Flow 25-75% (measured by a spirometer) is the average flow (or speed) of air coming out of the lung during the middle portion of the expiration. Age, height, and gender is used to determine what is normal. Change from BL could have been measured at any time during the study (up to Week 12), using the LOCF (for each individual, missing values are replaced by the last observed value of that variable). Change from BL is measured as percentage of predicted value, with height, gender, age, and race as variables (percentage of predicted value at endpoint minus value at BL).|Baseline through Week 12|Intent-to-Treat population.||Percentage of predicted value||Standard Deviation|Mean
140983|NCT00461500|Secondary|Change From Baseline in Pre-dose Forced Expiratory Vital Capacity (FVC) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FVC is the total amount of air that can forcibly be blown out after full inspiration, measured in liters. A spirometer is the device used to measure FVC. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat||Liters||Standard Deviation|Mean
140984|NCT00461500|Secondary|Change From Baseline in FEV1 Reversibility Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Reversibility is calculated as the percentage improvement of FEV1 from baseline. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable. Percent reversibility of FEV1 was calculated as follows: (Post-bronchodilator FEV1 – pre-bronchodilator FEV1)/pre-bronchodilator FEV1 x 100. A negative difference indicates less reversibility.|Baseline through Week 12|Intent-to-Treat population.||Percent change||Standard Deviation|Mean
140985|NCT00461500|Secondary|Change From Baseline in Pre-dose (Percent Predicted) FEV1 Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|Percent predicted is based on tables of normal values that use variables such as age, gender, and weight as a method of standardization. Spirometry results are expressed as a percentage, and are generally considered abnormal if less than 80 percent of the normal predicted value. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.||Percentage predicted of FEV1||Standard Deviation|Mean
141478|NCT00456521|Primary|Co-primary: Body Weight- Mean Percent Change||Baseline, 56 weeks|Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of body weight||Standard Error|Least Squares Mean
140986|NCT00461500|Secondary|Change From Baseline in Pre-dose FEV1 (Forced Expiratory Volume in One Second) Through Week 12 (Using Last Observation Carried Forward [LOCF] Approach)|FEV1 is the amount of air (in liters) you can blow out within one second. A spirometer is the device used to measure FEV1. With normal lungs and airways you can normally blow out most of the air from your lungs within one second. Age, height and gender is used to determine what is normal. Change from baseline could have been measured at any time during the study (up to Week 12), using the LOCF. In the LOCF approach, for each individual, missing values are replaced by the last observed value of that variable.|Baseline through Week 12|Intent-to-Treat population.||Liters||Standard Deviation|Mean
140987|NCT00461500|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Over Weeks 5-12|Mini Wright Peak Flow Meter used to allow patients to monitor their asthma - Peak Flow (or PEF - peak expiratory flow) is a measurement of how fast you can blow out. When someone is well, their PEF is higher - when the airways are narrow (as in asthma), PEF is lower. Readings based on age, height and gender.|Baseline, Weeks 5-12|Intent-to-Treat population are all randomized patients having received one study drug dose and had at least one complete efficacy assessment.||Liters per minute (L/min)||Standard Deviation|Mean
140988|NCT00461331|Secondary|Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place|Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.|Between 48, 72 and 96 hours after the last pump infusion line change|||pg/ml||Standard Deviation|Mean
140989|NCT00461331|Secondary|Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place|Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.|48 to 100 hours after keeping the same pump infusion line in place|||µg/ml||Standard Deviation|Mean
140990|NCT00461331|Primary|Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change|For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL.|24 to 100 hours after last pump infusion line change|The analysis was per protocol, intention to treat. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin.||Participants|||Number
140991|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 13 (364 days) with 28 days per cycle|FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||scores on a scale||Standard Deviation|Mean
140992|NCT00461305|Post-Hoc|Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Baseline and up to Cycle 6 (168 days) with 28 days per cycle|FAS||scores on a scale||Standard Deviation|Mean
140993|NCT00461305|Secondary|Change in Serum CRP From Baseline to Cycle 13|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||mg/dL||Full Range|Mean
140994|NCT00461305|Secondary|Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6|CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)||mg/dL||Full Range|Mean
140995|NCT00461305|Secondary|Change in Serum CA-125 From Baseline to Cycle 13|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||Units/mL||Full Range|Mean
140996|NCT00461305|Secondary|Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6|CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS(Participants with data at Cycle 6)||Units/mL||Full Range|Mean
140997|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||Percentage of participants|||Number
140998|NCT00461305|Secondary|Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||Percentage of participants|||Number
140999|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||Percentage of participants|||Number
141000|NCT00461305|Secondary|Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6|Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||Percentage of participants|||Number
141002|NCT00461305|Secondary|Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6|Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||participants|||Number
141003|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141004|NCT00461305|Secondary|Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||participants|||Number
141005|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||days||Full Range|Mean
141006|NCT00461305|Secondary|Number of Any Bleeding Days From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||days||Full Range|Mean
141007|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 13|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||number of episodes||Full Range|Mean
141008|NCT00461305|Secondary|Number of Any Bleeding Episodes From Cycle 1 to Cycle 6|Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)||number of episodes||Full Range|Mean
141009|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||scores on a scale||Full Range|Mean
141010|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||scores on a scale||Full Range|Mean
141011|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||scores on a scale||Full Range|Mean
141012|NCT00461305|Secondary|Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6|VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||scores on a scale||Full Range|Mean
141013|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141014|NCT00461305|Secondary|Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6|Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
141015|NCT00461305|Secondary|Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13|Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141017|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 13|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141018|NCT00461305|Secondary|Distribution of Severity of Headache During Menstruation at Cycle 6|Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
141019|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 13|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141020|NCT00461305|Secondary|Distribution of Severity of Lumbago During Menstruation at Cycle 6|Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
141021|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141022|NCT00461305|Secondary|Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6|Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
141023|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 13|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141024|NCT00461305|Secondary|Distribution of Total Dysmenorrhea Score at Cycle 6|Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
141025|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 13 (364 days) with 28 days per cycle|FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)||participants|||Number
141026|NCT00461305|Secondary|Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6|Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.|From baseline up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
141027|NCT00461305|Primary|Number of Participants With Intracyclic Bleeding at Cycle 6|Intracyclic bleedings were defined as bleedings while a participant takes active tablets.|Up to Cycle 6 (168 days) with 28 days per cycle|FAS (Participants with data at Cycle 6)||participants|||Number
141028|NCT00461292|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients’ lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Number on a Scale (Score)||Standard Deviation|Mean
141029|NCT00461292|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Centimeters of water (cm H2O)||Standard Deviation|Mean
141030|NCT00461292|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at Week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Milliliters (mL) of urine||Standard Deviation|Mean
142356|NCT00448630|Primary|Metabolic Syndrome Parameter High Density Lipoprotein (HDL)|Iterative measurement of HDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
141031|NCT00461292|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-To-Treat, defined as all patients who started the study (randomized)||Number of Weekly Episodes||Standard Deviation|Mean
141032|NCT00461253|Primary|Breast Cancer Risk|Breast cancer (invasive carcinoma or carcinoma in situ) in women aged <50 years at diagnosis. Cases were excluded if they had died before study start or had a history of malignancy.|retrospective, January 2000 to December 2007|Frequency of breast cancer (in situ and invasive) in LNG-IUD users and Cu-IUD users||participants|||Number
141033|NCT00461175|Other Pre-specified|Contraceptive Failure|Intrauterine contraceptive methods have low Pearl Indices. Nevertheless, there is a lack of comparative data between LNG IUS users and copper IUD users. Women with unintended pregnancies were explicitly aked whether the pregnancy occured despite IUD use. The 29 pregnancies that occured after unrecognized IUD expulsion were considered to have resulted from a failure of the contraceptive method and were therefore included in the analysis.|Within 12 months|||participants|||Number
141034|NCT00461175|Primary|Uterine Perforation Rate|Uterine perforation is a potentially serious complication of intrauterine device (IUD) use. The absolute risk of uterine perforation associated with the LNG IUS in routine medical practice has not hitherto been well defined. It is also unknown whether the perforation rate is higher with this IUD than with copper IUDs.|12 months after insertion|"Intention-to-treat (ITT) population. Number of Participants referring to the initially inserted IUS/IUD or the initial IUD insertion attempt."||participants|||Number
141035|NCT00461123|Secondary|Duration of Surgery|Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.|on the day of surgery, without any further allowable time window|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of duration of surgery; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||minutes||Standard Deviation|Mean
141036|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline documentation of number of incontinence episodes per week; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||urinary incontinence episodes||Standard Deviation|Mean
141037|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of post-void residual (PVR) volume; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||milliliter (mL)||Standard Deviation|Mean
141038|NCT00461123|Secondary|Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst).|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of International Prostate Symptom Score (IPSS) total score; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study."||scores on a scale||Standard Deviation|Mean
141039|NCT00461123|Primary|Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)|Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.|baseline and up to 3 months after surgery|"The intent-to-treat (ITT) population includes participants with baseline and post-baseline measurement of peak urinary flow; imputation technique: last post-baseline observation carried forward (LOCF). The ITT population is not identical to the number of subjects who completed the study, as displayed under Participants Flow."||milliliter per second (mL/s)||Standard Deviation|Mean
141040|NCT00461097|Secondary|Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid|Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment.|4 years (48 months)|||percentage of participants|||Number
141041|NCT00461097|Secondary|Number of Participants With Serious Adverse Events (SAEs)|This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.|Baseline through the 2-year primary endpoint|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||participants|||Number
141070|NCT00460746|Secondary|Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.||percentage of participants|||Number
141042|NCT00461097|Secondary|Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg|For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
141043|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation|On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur.|Initial day of dosing|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
141044|NCT00461097|Secondary|Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid|Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes.|Following the blinded desensitization phase at approximately Week 44|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
141045|NCT00461097|Primary|Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes.|At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.||percentage of participants|||Number
141046|NCT00461032|Secondary|Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.|8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data.||Percentage of Days||95% Confidence Interval|Least Squares Mean
141047|NCT00461032|Secondary|Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants||8 Week treatment period initiated at the beginning of a school year|The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data.||Percentage of Days||95% Confidence Interval|Least Squares Mean
141048|NCT00461032|Secondary|Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)|Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.|8 Week treatment period initiated at the beginning of a school year|The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available.||Participants|||Number
141049|NCT00461032|Primary|Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants|"A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake all night; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization."|8 Week treatment period initiated at the beginning of a school year|The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.||Percentage of Days||95% Confidence Interval|Least Squares Mean
141050|NCT00460811|Secondary|Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period|During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=very severe|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).||units on a scale||Standard Error|Least Squares Mean
141051|NCT00460811|Secondary|Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period|Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 13 patients who dropped out prior to finishing 1 week of the trial have missing data.||units on a scale||Standard Error|Least Squares Mean
141052|NCT00460811|Secondary|Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis.||units on a scale||Standard Error|Least Squares Mean
142357|NCT00448630|Primary|Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)|Iterative measurement of LDL. Mean at time points|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
141053|NCT00460811|Secondary|Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period|Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid).|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency). 15 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis.||units on a scale||Standard Error|Least Squares Mean
141054|NCT00460811|Secondary|Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period|SBMs were measured daily during the treatment period by patient calls to the IVRS.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).||SBMs per week||Standard Error|Least Squares Mean
141055|NCT00460811|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥ 4 days of IVRS questions, 2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from the baseline weekly CSBM rate.|Change from Baseline to Week 12|The ITT Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency).||participants|||Number
141056|NCT00460811|Primary|Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period|"The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period.~The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours."|Change from Baseline to Week 12|The Intent-to-treat (ITT) Population included 419 patients of the Safety Population who also had ≥ 1 post-dose evaluation of the primary efficacy assessment (i.e., CSBM Frequency)||CSBMs per week||Standard Error|Least Squares Mean
141057|NCT00460798|Primary|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores|EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems|Baseline, 3, 6, 9 and 12 Months|FAS. n=number of participants with EORTC scale score data available at each specified time point||Scores on Scale||Standard Deviation|Mean
141058|NCT00460798|Primary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status|Baseline, 3, 6, 9 and 12 Months|FAS. ECOG performance status data was not reported for 24, 32, 96, 174, and 174 participants at baseline, 3, 6, 9, and 12 months, respectively.||Participants|||Number
141059|NCT00460798|Primary|Time to Progression (TTP)|TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.|Start of Treatment up through 12 Months or Early Discontinuation|FAS. Number of participants with progression = 162; Number of participants censored = 190||Months||95% Confidence Interval|Median
141060|NCT00460798|Primary|Number of Participants With Objective Response|Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|12 Months or Early Discontinuation|FAS||Participants|||Number
141061|NCT00460798|Primary|Number of Participants With Categorical Best Overall Response|Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)=≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)=≥20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of ≥1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Start of Treatment up through 12 Months or Early Discontinuation|Full Analysis Set (FAS) = All participants who had taken at least 1 dose of study medication and had a post baseline efficacy measurement||Participants|||Number
141062|NCT00460746|Secondary|Median Change From Baseline in Glucose at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
141063|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.||Week 48|ITT , LOCF.||ratio of TC and HDL||Full Range|Median
141064|NCT00460746|Secondary|Median Change From Baseline in HDL Cholesterol.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
141065|NCT00460746|Secondary|Median Change From Baseline in LDL Cholesterol at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
141066|NCT00460746|Secondary|Median Change From Baseline in Total Cholesterol at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
141067|NCT00460746|Secondary|Median Change From Baseline in Triglycerides at Week 48.||Week 48|ITT , LOCF.||mg/dL||Full Range|Median
141068|NCT00460746|Secondary|CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.||Week 48|ITT , LOCF.||cells/mm^3||Standard Deviation|Mean
141071|NCT00460746|Primary|Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.||48 weeks|ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.||percentage of participants|||Number
141072|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141073|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141074|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141075|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The time (seconds) required to walk 10 meters was measured at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||seconds||Standard Deviation|Mean
141076|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141077|NCT00460655|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to Week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141078|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141079|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141080|NCT00460655|Secondary|Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141081|NCT00460655|Secondary|Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase|The time (seconds) required to walk 10 meters was measured at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||seconds||Standard Deviation|Mean
141082|NCT00460655|Secondary|Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase|The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141083|NCT00460655|Secondary|Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Points on a scale||Standard Deviation|Mean
141084|NCT00460655|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12)|Change from baseline in MAS ankle score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score||Score*week||Standard Deviation|Mean
141085|NCT00460603|Secondary|Change From Baseline in M.D. Anderson Symptom Assessment Inventory - Diarrhea (MDASI-D) Symptom Severity and Interference Subscale Scores at Day 1 of Cycle 2 Through Day 1 Cycle 42 and Follow-up: Phase 2|PROs included assessment of symptom severity and interference which were measured using M.D. Anderson Symptom Assessment Inventory-Diarrhea (MDASI-D), 20-item questionnaire which assesses the severity of 14 symptoms over the past 24 hours, as well as symptoms interference with 6 areas of function (e.g., walking, work, mood), when the symptom was “at its worst”. Each item is scored from 0 to 10, with ‘0’ indicating that the symptom was either not present or did not interfere with their activities, and ‘10’ indicating that the symptom was “as bad as you can imagine” or “interfered completely” with their life. The 2 subscales, symptom severity score and symptom interference score were average of respective items and ranged from 0 to 10, higher score indicating greater severity or interference of symptoms.|Cycle 1 Day 1 (baseline), every 2 weeks for the first 2 months (Cycle 2 Day 1 [C2D1], Cycle 3 Day 1, and Cycle 4 Day 1) then monthly thereafter starting Cycle 6 Day 1, and 28 days after the last dose|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||units on scale||Standard Deviation|Mean
141086|NCT00460603|Secondary|Overall Survival (OS): Phase 2|Time in days from randomization date to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Every 3 months after discontinuation of study treatment until death due to any cause or 1 year after randomization of the last participant|ITT population included all randomized participants , with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||days||95% Confidence Interval|Median
141087|NCT00460603|Secondary|Time to Treatment Failure (TTF): Phase 2|TTF is defined as the time from the randomization to the date of the first documentation of PD, symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||days||95% Confidence Interval|Median
141088|NCT00460603|Secondary|Progression-Free Survival (PFS): Phase 2|"Time in days from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation."|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||days||95% Confidence Interval|Median
141089|NCT00460603|Secondary|Duration of Response (DR): Phase 2|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR: disappearance of all lesions and no appearance of new lesions. PR: >=30% decrease in sum of LD of target lesions taking as reference the baseline sum LD, without progression of nontarget lesions and no appearance of new lesions. Progression: >=20% increase in sum of LD of target lesions taking as references the smallest sum LD recorded since treatment start, unequivocal progression of existing nontarget lesions, or appearance of new lesions, occurrence of pleural effusion/ascites, substantiated by cytologic investigation.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|ITT population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. 'N' (Number of participants analyzed)= those participants who were evaluable for this measure.||days||95% Confidence Interval|Median
141090|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Bevacizumab: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. t1/2 for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
141091|NCT00460603|Secondary|Clearance (CL) For Bevacizumab: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. CL for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
141092|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Bevacizumab: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
141093|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Bevacizumab: Phase 1|PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. Cmax for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
141094|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Bevacizumab: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141095|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Bevacizumab: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of bevacizumab were combined for Cohorts 1, 2, and 3. AUClast for bevacizumab in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. The bevacizumab pharmacokinetic parameters were normalized to 1 mg/kg dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141096|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Irinotecan: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. t1/2 for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
141124|NCT00460577|Secondary|Pharmacoeconomic Analysis|Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.|4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||Cost in US Dollars||Full Range|Mean
141097|NCT00460603|Secondary|Clearance (CL) For Irinotecan: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
141098|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Irinotecan: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
141099|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Irinotecan: Phase 1|Cmax for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
141100|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Irinotecan: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141101|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Irinotecan: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast for irinotecan in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 irinotecan dose.|Predose, 1, 2, 2.5, 4, 6, 8, 24 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141102|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For 5-Fluorouracil: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. t1/2 for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
141103|NCT00460603|Secondary|Clearance (CL) For 5-Fluorouracil: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. CL for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
141104|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For 5-Fluorouracil: Phase 1||Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
141105|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For 5-Fluorouracil: Phase 1|PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. Cmax for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
141106|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For 5-Fluorouracil: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141107|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For 5-Fluorouracil: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of 5-FU were combined for Cohorts 1, 2, and 3. AUClast for 5-FU in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 5-FU dose.|Pre-5-FU bolus, 5 min (post-5-FU bolus), 0.25, 0.5, 0.75, 2, 4, 6, 22, 34-46 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141108|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Oxaliplatin: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. t1/2 for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
141109|NCT00460603|Secondary|Clearance (CL) For Oxaliplatin: Phase 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. CL for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||95% Confidence Interval|Geometric Mean
141110|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Oxaliplatin: Phase 1||Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
141111|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Oxaliplatin: Phase 1|PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. Cmax for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
141112|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Oxaliplatin: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUC (0 - ∞) for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141113|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Oxaliplatin: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). PK parameters of oxaliplatin, assessed by estimating total platinum in plasma ultrafiltrate, were combined for Cohorts 1, 2, and 3. AUClast for oxaliplatin in absence of axitinib was estimated from Cycle 1 Day 1 data and in presence of axitinib was estimated from Cycle 2 Day 1 data. Results were normalized to Cycle 1 Day 1 oxaliplatin dose.|Predose, 1, 2, 2.25, 2.5, 4, 6, 8, 24, 36-48 hours postdose on Cycle 1 Day 1, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141114|NCT00460603|Secondary|Plasma Decay Half-Life (t1/2) For Axitinib: Phase 1|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. t1/2 for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
141125|NCT00460577|Secondary|Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events|Not posted: see comment in Limitations and Caveats.|4 hours||||||
141126|NCT00460577|Primary|Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||Liters/minute||Standard Deviation|Mean
141115|NCT00460603|Secondary|Apparent Oral Clearance (CL/F) For Axitinib: Phase 1|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. CL/F for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
141116|NCT00460603|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) For Axitinib: Phase 1||Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK assessments were done only for cohort 1 to 5, as per planned analysis. Results for Cmin are not reported because Cmin could not be assessed from the data obtained from the study.|||||
141117|NCT00460603|Secondary|Maximum Observed Plasma Concentration (Cmax) For Axitinib: Phase 1|PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3.Cmax for axitinib (AG-013736) in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||95% Confidence Interval|Geometric Mean
141118|NCT00460603|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] For Axitinib: Phase 1|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It was obtained from AUC (0 - t) plus AUC (t - ∞). PK parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUC (t - ∞] for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6, 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||ng*hr/mL||95% Confidence Interval|Geometric Mean
141119|NCT00460603|Secondary|Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Axitinib: Phase 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). Pharmacokinetic (PK) parameters of axitinib (AG-013736) were combined for Cohorts 1, 2, and 3. AUClast for axitinib in absence of bevacizumab + FOLFOX was estimated from Cycle 1 Day 8 data and in presence of bevacizumab + FOLFOX was estimated from Cycle 2 Day 1 data. Results were normalized to axitinib 5 mg dose.|Predose, 1, 2, 2.5, 4, 6 and 8 hours postdose on Cycle 1 Day 8, Cycle 2 Day 1|PK parameter analysis set included all treated participants who had at least 1 estimated PK parameters of primary interest. PK assessments were done only for cohort 1 to 5, as per planned analysis. Here 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.||nanogram hour per milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
141120|NCT00460603|Primary|Percentage of Participants With Objective Response: Phase 2|Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline (Phase 2) until disease progression, assessed every 6 weeks up to Week 148 (Phase 2) or follow-up (every 6 weeks after last dose of study drug until progression or start of alternate therapy)|Intent-to-treat (ITT) population included all randomized participants, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
141121|NCT00460577|Primary|Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||score on a scale||Standard Deviation|Mean
141122|NCT00460577|Primary|Mean Change in Pulse Oxymetry From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.|Baseline, 4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||percentage||Standard Deviation|Mean
141123|NCT00460577|Primary|Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation|Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.|Baseline,4 hours|Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.||Liters||Standard Deviation|Mean
142358|NCT00448630|Primary|Metabolic Syndrome Parameter Total Cholesterol|Iterative measurement of total cholesterol. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
141127|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141128|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141129|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141130|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Limb Posture at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Weeks 12 to 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141131|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Dressing at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141132|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Pain at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141133|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Hygiene at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability; 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141158|NCT00460525|Primary|Number of Subjects Reporting Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence that results in death, is life threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization or is a congenital anomaly/birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above was considered serious.|24 months after initial vaccination|||Participants|||Number
141134|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Principal Measure at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point from baseline (at the start of the double-blind phase) to Week 48.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141135|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Finger Score From at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141136|NCT00460564|Secondary|Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Wrist Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase|The investigator assessed the MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=no increase in muscle tone to 4=affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to week 48. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder ([less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141137|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141138|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141139|NCT00460564|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase|The CGI score of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141140|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase|DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141141|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase|DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141142|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase|DAS score of pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141143|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase|DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141202|NCT00459979|Secondary|Median Size Reduction Among Tumors With Some Shrinkage|The median size reduction in the largest diameter of the primary RCC tumor among the tumors with at least some shrinkage in diameter|1 year from start of treatment|||cm|Participants|Full Range|Median
141144|NCT00460564|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase|DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point in the double-blind phase.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141145|NCT00460564|Secondary|Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed MAS finger score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141146|NCT00460564|Secondary|Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase|The investigator assessed MAS wrist score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The “+1” (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5.|Baseline; Weeks 1, 4, 6, 8, and 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Points on a scale||Standard Deviation|Mean
141147|NCT00460564|Secondary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the Low-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis (HA) and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the area under the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Score*week||Standard Deviation|Mean
141148|NCT00460564|Primary|Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups|Change from baseline in MAS wrist score using a 6-point scale (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.|Baseline, Week 12|Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS wrist score||Score*week||Standard Deviation|Mean
141149|NCT00460551|Primary|Progression Free Survival Verified by Imaging Techniques.|Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16|Until disease progression|Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.||Participants|||Number
141150|NCT00460551|Secondary|Adverse Events|Number of participants reporting at least one adverse event|Up to 3 months|Number of patients reporting at least one adverse event||participants|||Number
141151|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 730.|Day 730 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141152|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 547.|Day 547 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141153|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 364.|Day 364 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141154|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 240.|Day 240 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141155|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 150.|Day 150 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141156|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 90.|Day 90 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141157|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 60, prior to the third vaccination.|Day 60 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141159|NCT00460525|Primary|Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.|Time to first clinical malaria episode is displayed in a life table format to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point.|Occurring between randomization and 6 months after the assigned date of the 3rd immunization.|||Participants|||Number
141160|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after third vaccination|All subjects receiving the vaccination are included.||Adverse Events|||Number
141161|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after second vaccination|All subjects receiving the vaccination are included.||Adverse Events|||Number
141162|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30.|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 30, prior to the second vaccination.|Day 30 after initial vaccination|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141163|NCT00460525|Secondary|Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0|Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 0 prior to the first vaccination.|Day 0|Analyses are ITT. No imputation techniques were used.||Titer||95% Confidence Interval|Geometric Mean
141164|NCT00460525|Secondary|Time to First Clinical Malaria Episode With Parasites With AMA-1 Genotype Homologous to the 3D7 Strain of P. Falciparum With Respect to Entire AMA-1 Sequence and With Respect to Key Amino Acid Residues.||Occurring between randomization and 6 months after the assigned date of the 3rd immunization.||||||
141165|NCT00460525|Secondary|Incidence Density of Clinical Malaria Episode|Clinical malaria episode was defined by significant parasitemia (2500/mm^3) and temperature of greater than or equal to 37.5 degrees C. Event rate was determined by dividing the number of episodes (150 for the Rabies group and 121 for the FMP2.1/ASO2A group) by the number of Person Years at Risk (PYAR) (126.341 for Rabies group and 127.411 for the FMP2.1/ASO2A group).|Between randomization and 6 months after 3rd immunization.|Analyses are ITT.||Events Per PYAR|||Number
141166|NCT00460525|Primary|Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination|Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.|Day 0-29 after first vaccination|All subjects receiving the vaccination are included.||Adverse Events|||Number
141167|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the third vaccination|All subjects receiving the vaccination are included.||Participants|||Number
141168|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after the second vaccination|All subjects receiving the vaccination are included.||Participants|||Number
141169|NCT00460525|Primary|Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination|"Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after each vaccination. Reported Limitation of Arm Motion refers to the parents' report of the symptom while Limitation of Arm Motion refers to the clinicians' assessment of the symptom, collected separately."|0-7 days after first vaccination|All subjects receiving the vaccination are included.||Participants|||Number
141170|NCT00460421|Secondary|Long-Term Follow-Up: Overall Survival|Overall survival was defined as the number of days from the date of first investigational product administration to the date of death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||months||Full Range|Median
141171|NCT00460421|Secondary|Long-Term Follow-Up: Progression Free Survival|Progression free survival (PFS) was defined as the number of days between the date of first investigational product administration and the date when physical or radiological evidence of disease progression is determined or death (regardless of cause)|Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||months||Full Range|Median
141172|NCT00460421|Secondary|Long-Term Follow-Up: Incidence of Secondary Malignancies||Up to 4 years duration (Assessments performed on months 6, 9, 12 (+/- 30 Days) for the first year and then annually)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
141173|NCT00460421|Secondary|Pharmacokinetics of Palifermin, AUCtau After the 3rd IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)~Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||ng*hr/mL||Full Range|Median
141174|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Area Under the Concentration Time Curve From Zero to the End of the Dosing Interval (AUCtau) After the 1st IV Bolus Injection for Multiple Dose Levels|"The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)~Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose."|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||ng*hr/mL||Full Range|Median
141175|NCT00460421|Secondary|Pharmacokinetics of Palifermin, t½,z After the 3rd IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -8|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||hour||Full Range|Median
141176|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Terminal Half-life (t½,z) After the 1st IV Bolus Injection for Multiple Dose Levels|The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||hour||Full Range|Median
141177|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Volume of Distribution at Steady State (Vss) After the 1st IV Bolus Injection for Multiple Dose Levels||Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||mL/kg||Full Range|Median
141178|NCT00460421|Secondary|Pharmacokinetics of Palifermin, Clearence (CL) After the 1st Intravenous (IV) Bolus Injection for Multiple Dose Levels|Clearence was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity where the dose was given in amount palifermin actually administered.|Day -10|Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.||mL/hr/kg||Full Range|Median
141179|NCT00460421|Secondary|Incidence of Laboratory Abnormalities|The percentage of participants with a laboratory value outside the normal ranges during the study.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
141180|NCT00460421|Secondary|Incidence of Severe Adverse Events (AEs)|The percentage of participants with a severe AE during the study was assessed.|Approximately 1 1/2 months duration (Through Day +30/End of Treatment)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
141181|NCT00460421|Secondary|Incidence of Serum Palifermin Antibody Formation|The percentage of participants developing palifermin antibodies during the study was assessed.|Approximately 4 month duration (Through Day + 100 (+/- 40 days))|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
141182|NCT00460421|Primary|Incidence of Dose Limiting Toxicities (DLTs)|"A DLT is appearance of side effects during treatment severe enough to prevent further increase in dosage or strength of treatment agent, or to prevent continuation of treatment at any dosage level.~A DLT was defined as: Grade 3 or 4 AE [based on Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) v3.0] considered by the investigator to be related to palifermin with the exceptions: Grade 3 erythema, pruritus or rash that resolves within 7 days of the last dose of palifermin.~The percentage of particiapnts with a DLT during the study was assessed."|Approximately 1 month duration (Day -10 through Day +16)|Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.||percentage of participants|||Number
141183|NCT00460408|Secondary|Number of Participants With Serious Hypersensitivity Reactions|Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms.|Baseline up to 2 years|Safety Population||participants|||Number
141184|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≥ 75 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
141185|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 65 to 74 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
141186|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants 51 to 64 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
141187|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of participants ≤50 years old||percent per injection|Participants||Number
141188|NCT00460408|Primary|Incidence of POAEs Per Injection Reported by Gender (Females)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of female participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
141189|NCT00460408|Secondary|Incidence of POAEs Per Injection Reported by Gender (Males)|POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population subset of male participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
141190|NCT00460408|Primary|Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection|POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.|Baseline up to 2 years|Safety Population: participants who received at least 1 Macugen (pegaptanib sodium) injection; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group.||percent per injection|Participants||Number
141191|NCT00460265|Secondary|Progression Free Survival|Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.|Every 6 weeks until disease progression or deaths, upto 56 months|ITT||months||95% Confidence Interval|Median
141192|NCT00460265|Secondary|Time to Response|Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.|Every 6 weeks until disease progression, upto 56 months|Included only those subjects with a confirmed complete response or partial response.||months||Inter-Quartile Range|Median
141193|NCT00460265|Secondary|Time to Progression|Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)|Every 6 weeks until disease progression, up to 56 months|ITT||months||95% Confidence Interval|Median
141194|NCT00460265|Secondary|Duration of Response|Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).|Every 6 weeks until disease progression, up to 56 months|Included only those subjects with a confirmed complete or partial response.||months||95% Confidence Interval|Median
141195|NCT00460265|Secondary|Overall Response Rate|An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.|Every 6 weeks until disease progression, up to 56 months|The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H)||subjects|||Number
141196|NCT00460265|Primary|Overall Survival|Time from randomization to death|Upto 56 months|Intention to treat (ITT)||months||95% Confidence Interval|Median
141197|NCT00460031|Secondary|Ratio of Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the ratio of BDCA-2 to BDCA-1 cells|Week 8|All patients who completed the study||ratio||Standard Deviation|Mean
141198|NCT00460031|Secondary|Change in Immune Response From Baseline|The pattern of immune response by assessing T cell and dendritic cell markers, specifically by measuring the levels of CD4+ FoxP3+ Regulatory T cells|Week 8|All patients who completed the study||cells/ul||Standard Deviation|Mean
141199|NCT00460031|Secondary|Number of Patients With Grade 3 and 4 Toxicity as Assessed by NCI CTCAE v3.0|Patients will be evaluated for toxicity every 2 weeks during the first cycle. Thereafter, evaluations will be done every 28 days or more frequently if clinically indicated.|Up to 30 days after discontinuation of treatment|All patients who received at least one treatment in the study||participants|||Number
141200|NCT00460031|Secondary|Time to Progression|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|One year (12 months) after start of treatment|Patients with disease progression||Months||95% Confidence Interval|Median
141201|NCT00460031|Primary|Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease|Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy will continue until criteria for progressive disease are met. Response is based on the RECIST criteria from the National Cancer institute. Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions from baseline; Progressive Disease (PD) >= increase in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD) neither sufficient for partial response nor sufficient increase for progressive disease.|28 days|All patients who completed the study||participants|||Number
151576|NCT00373360|Secondary|Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
141205|NCT00459979|Secondary|Percent Decrease of Diameter of Primary Tumors|Median percent decrease in size in all primary renal cell carcinoma tumors. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib||percentage of tumors diameter decrease|Participants|Full Range|Median
141206|NCT00459979|Secondary|Progression Free Survival|Progression free survival is defined as the amount of time (in months) between the start of treatment and documented RECIST defined progression. RECIST progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition to an absolute increase of at least 5mm.|1 year from start of treatment|||months||Full Range|Median
141207|NCT00459979|Secondary|The Number of Patients With Any Type of Complication or Adverse Event|The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.|1 year from start of treatment|||participants|||Number
141208|NCT00459979|Primary|Response to Sunitinib Therapy|Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason|1 year from start of treatment|per protocol - analysis after at least one cycle of Sunitinib||participants|||Number
141209|NCT00459953|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as a report of nonsmoking (not even a puff) for 7 consecutive days prior to assessment and an expired-air carbon monoxide level below 9 parts per million (ppm)|6 months|||participants|||Number
141210|NCT00459875|Primary|Overall Objective Response Rate as Measured by RECIST||2 years|||participants|||Number
141211|NCT00459862|Secondary|Overall Response Rate|"To evaluate the confirmed response rate of pazopanib in patients with MPM based on the RECIST criteria for MPM. Responses are confirmed by repeat assessments that are be performed no less than 4 weeks after the criteria for response are first met.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Participants will be evaluated every cycle during treatment, up to 2 years|All 34 participants were evaluable for this endpoint.||percentage of patients||95% Confidence Interval|Number
141212|NCT00459862|Secondary|Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.|"Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline LD."|From study enrollment to the first date of disease progression|All 34 participants were evaluable for this endpoint.||participants|||Number
141213|NCT00459862|Secondary|Determine the Clinical Toxicities of This Drug in This Participant Population.|The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.|Participants will be evaluated every cycle during treatment|All 34 participants were evaluable for adverse events.||participants|||Number
141214|NCT00459862|Secondary|Progression-free Survival Assessed by RECIST||From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years|All 34 participants were analyzed for this endpoint.||months||95% Confidence Interval|Median
141215|NCT00459862|Secondary|Overall Survival||From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years|All 34 participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
141216|NCT00459862|Primary|Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)|The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.|6 months|All 34 participants were analyzed for this endpoint.||percentage of participants|||Number
141217|NCT00459810|Secondary|Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response|These correlative analyses were not completed. As there were no PSA responses, it was not possible to correlate serum estradiol, serum cathepsin B, or bone turnover markers with PSA response.|Measured after 4 cycles of combination therapy|||Participants|||Number
141218|NCT00459810|Secondary|Time to Death|Defined as time from Day 1 of study regimen to Date of death from any cause.|Measured at Date of Death from any cause|||Months||95% Confidence Interval|Median
141219|NCT00459810|Secondary|Time to Disease Progression|Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression|At time of progression by PSA or RECIST criteria|||Days||95% Confidence Interval|Median
141220|NCT00459810|Secondary|Measurable Disease Response Rate (Soft Tissue)|Measurable disease response rate by RECIST criteria. Response is defined as at least a 30% decrease in the sum of the longest diameter in measurable lesions (larger than 10mm at baseline).|While receiving study agents (on average, 3 months)|||Participants|||Number
141221|NCT00459810|Primary|Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%|PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.|While receiving study agents (on average, 3 months)|||Participants|||Number
141222|NCT00459732|Secondary|Osteocalcin, a Marker of Bone Formation|Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups|Baseline to 18 months|Intention to treat analysis||ng/mL||Standard Deviation|Mean
141223|NCT00459732|Primary|Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)||Baseline to 18 months|Intention to treat analysis in those who completed the 18 month timepoint (zinc vs. placebo)||Percent change||Standard Deviation|Mean
141224|NCT00459732|Primary|Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)|Change in pa spine bone mineral density by DXA between baseline and 18 months|0 to 18 months|Intention to treat analysis of all subjects who completed the protocol in each arm of the study (zinc vs. placebo).||Percent Change||Standard Deviation|Mean
141372|NCT00458406|Secondary|Change in NOSE Scale Score From Month 1 to Month 3|Change in the total Nasal Obstruction Symptom Evaluation (NOSE) scale score (Score at Month 3 minus Score at Month 1). This scale evaluates the severity of nasal obstructive symptoms. The scale ranges from 0-20, with a higher score indicating more nasal obstruction.|3 months|||units on a scale||Standard Deviation|Mean
141225|NCT00459706|Secondary|Participant Satisfaction at Endpoint Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean participant satisfaction was determined for each cluster of participants. Satisfaction was scored on a 10-point scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
141226|NCT00459706|Secondary|Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 3 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 3 DMARDs who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants receiving only 3 DMARDs who reported themselves as very satisfied, satisfied , or not satisfied for the specified treatment arm.||percentage of participants|||Number
141227|NCT00459706|Secondary|Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 2 DMARDs was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 2 DMARDs, who reported themselves as very satisfied, satisfied, or not satisfied. n=number of participants receiving only 2 DMARDs who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm.||percentage of participants|||Number
141228|NCT00459706|Secondary|Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all participants receiving DMARDs (only 1, only 2, only 3, 4 or more DMARDs) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants receiving only 1 DMARD was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters receiving only 1 DMARD who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.||percentage of participants|||Number
141229|NCT00459706|Secondary|HAQ-DI Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAQ-DI Score, assessing the extent of functional ability, was determined for each cluster of participants. Disability score ranged from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
141230|NCT00459706|Secondary|Physician's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Mean Physician's Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||millimeters on the VAS||Standard Deviation|Mean
141231|NCT00459706|Secondary|Participant's Global Assessment of RA Activity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Participants' mean Global Assessment of RA Activity was determined for each cluster of participants. VAS scores ranged from 0 (inactive) to 100 mm (extremely active).|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||millimeters on the VAS||Standard Deviation|Mean
141250|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q21: How Much Do You Like the Feel of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141232|NCT00459706|Secondary|DAS28 Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean DAS28 Score was determined for each cluster of participants. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
141233|NCT00459706|Secondary|RA Duration Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean RA Duration was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied , or not satisfied for the specified treatment arm and cluster.||years||Standard Deviation|Mean
141234|NCT00459706|Secondary|Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using a multiple correspondence analysis and an ascending hierarchical classification. The percentage of participants with prior self-injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||percentage of participants|||Number
141235|NCT00459706|Secondary|Percentage of Participants With Prior Injection Experience Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants with prior injection experience was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||percentage of participants|||Number
141236|NCT00459706|Secondary|PAM Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean PAM Score was determined for each cluster of participants. Calibrated PAM scale score ranged from 0 to 100.Higher scores indicated more confidence in managing participants' condition and lifestyle.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
141237|NCT00459706|Secondary|HAD Depression Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Depression Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
141238|NCT00459706|Secondary|HAD Anxiety Subscale Score Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean HAD Anxiety Subscale Score was determined for each cluster of participants. Score ranged from 0 to 21. Lower scores indicated better health.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and cluster.||units on a scale||Standard Deviation|Mean
141239|NCT00459706|Secondary|Percentage of Participants at University Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at the university level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.||percentage of participants|||Number
141240|NCT00459706|Secondary|Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants at high school/baccalaureate level was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants at all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.||percentage of participants|||Number
141241|NCT00459706|Secondary|Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants in all 3 social-educational level (only reading/writing capacity, high-school level, university level) were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants with only reading/writing capacity was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 social-educational levels and across all 3 clusters who reported themselves as very satisfied, satisfied, or not satisfied. n=participants across all 3 levels reporting themselves as very satisfied, satisfied, or not satisfied for the specified treatment arm.||percentage of participants|||Number
141242|NCT00459706|Secondary|Percentage of Female Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. Percentage of participants who were female was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants (male+female) across all 3 clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants (male+female) who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm and gender.||percentage of female participants|||Number
141243|NCT00459706|Secondary|Percentage of Male Participants Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, all male and female participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The percentage of participants who were male was determined for each cluster of participants.|Day 84|mITT. n=number of participants (male plus female) who reported themselves as being very satisfied, satisfied, or not for the specified treatment arm.||percentage of male participants|||Number
141244|NCT00459706|Secondary|Age Associated With Participant Perception|Participant perception was assessed with the 26 questions in the Device Attribute and Participant Questionnaire. Based on the scores assigned to the 26 questions, participants were grouped into 3 clusters (Cluster 1=very satisfied, Cluster 2=satisfied, Cluster 3=not satisfied) using multiple correspondence analysis and ascending hierarchical classification. The mean age was determined for each cluster of participants.|Day 84|mITT. Number of participants analyzed (N)=total number of participants across all 3 age clusters who reported themselves as being very satisfied, satisfied, or not satisfied. n=number of participants who reported themselves as being very satisfied, satisfied, or not satisfied for the specified treatment arm.||years||Standard Deviation|Mean
141245|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q26: If Your Doctor Advised You to, How Likely Would You to Be Continue Injecting Regularly With this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very likely.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141246|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q25: Would You Recommend this Device to Someone Else Who Needed to Self Inject? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=yes definitely.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141247|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Likely Is It That You Would Use the Device Again - Q24: To What Extent Would You Consider Alternative Devices If You Were to Continue on Etanercept? Participants specified their responses on a 5-point Likert scale: 0=very little to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141248|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: Side Effects from Using the Device - Q23: Do You Experience Pain During or Immediately After the Injection? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141249|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q22: How Much Does the Device Look Like Something You Would Feel Comfortable to Use? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141251|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: What Characteristics of the Device You Appreciate - Q20: How Much Do You Like the Look of the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141252|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q19: Overall, Are You Emotionally Distressed or Anxious about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141253|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q18: Do You Dislike Injecting Yourself with this Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141254|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q17: Overall, How Nervous Do You Feel about Inserting the Needle into Your Skin? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141255|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How You Feel When Using the Device - Q16: Overall, How Nervous Do You Feel about Your Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141256|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q15: How Confident Are You That You Injected Yourself Successfully? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141257|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q14: Are You Confident That You Have Good Control over the Injection Process? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141258|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q13: How Confident Are You That You Can Inject Yourself Properly with the Device? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141259|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q12: How Confident Are You That You Inject the Right Amount of Medicine Every Time? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141260|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Confident You Feel When Using the Device - Q11: Overall, How Confident Are You in Your Management of Your Weekly Injections? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141261|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q10: How Much Do You Think Injecting Etanercept Will Interfere with Travelling on Holiday/ Business/Visiting? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141262|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q9: Do You Think Injecting Etanercept Will Interfere with Your Usual Daily Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141263|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Convenient You Find the Device Is to Use - Q8: How Much Do You Think Injecting Etanercept Will Interfere with Your Ability to Enjoy Social or Leisure Activities? Participants specified their responses on a 5-point Likert scale: 0=not at all to 4=very much.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141264|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q7: How Long Does It Take to Perform the Injection, Including any Preparation and Disposal? Participants specified their responses on a 5-point Likert scale: 0=<5 minutes to 4=>30 minutes.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141265|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q6: Did You Feel any Hand Discomfort Whilst Using the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141266|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q5: How Easy Is It to Hold the Device Whilst Injecting? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141267|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q4: How Easy Is It to Know When the Injection Is Completed? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141268|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q3: How Easy Is It to Dispose Of the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141269|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q2: How Easy Was It to Learn to Use the Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141270|NCT00459706|Secondary|Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84|Percentage of participants responding to Device Attributes and Subject Perceptions Questionnaire: How Easy You Find the Device Is to Use - Q1: Overall, How Easy Was It to Perform an Injection with this Device? Participants specified their responses on a 5-point Likert scale: 0=very easy to 4=very difficult.|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141271|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?|"Score indicated satisfaction in response to the question How satisfied are you with all the treatments you are currently receiving for your rheumatoid arthritis? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
141272|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?|"Score indicated satisfaction in response to the question How satisfied are you with your health? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
141273|NCT00459706|Secondary|Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?|"Score indicated satisfaction in response to the question Thinking about your own life and personal circumstances, how satisfied are you with your life as a whole? Score ranged from 0=completely dissatisfied to 10=completely satisfied. Higher scores indicated greater satisfaction."|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
141274|NCT00459706|Secondary|Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score|The SF-STAI consisted of 6 questions, each scored from 1 to 4. Total score ranged from 6=less anxiety to 24=more anxiety. Higher score indicated that the participant was more anxious.|Day 84|mITT. N=number of evaluable participants.||units on a scale||Standard Deviation|Mean
141275|NCT00459706|Secondary|Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior injection experience. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. n=evaluable participants in that category.||units on a scale||Standard Deviation|Mean
141276|NCT00459706|Secondary|Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants were categorized into those who received only 1 DMARD, only 2 DMARDs, only 3 DMARDs, and at least 3 DMARDs.|Day 84|mITT; LOCF. N=total evaluable participants. n=total evaluable participants for that category.||units on a scale||Standard Deviation|Mean
141277|NCT00459706|Secondary|Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The 20-item HAQ-DI assessed the extent of participants' functional ability. Calculation yielded a single disability score from 0=normal or no difficulty to 3=unable to do. Lower HAQ-DI scores indicated better health. Results are reported by categories of HAQ-DI scores observed: <=0.9, >0.9-1.4, >1.4-1.9, >1.9.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141278|NCT00459706|Secondary|Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Physicians' global assessment of disease activity was measured on a VAS ranging from 0 (inactive) to 100 mm (extremely active). Results are reported by VAS scores observed for physician's global assessment of RA activity: <=47 mm, >47-61 mm, >61-72 mm, >72 mm.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141279|NCT00459706|Secondary|Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Participants' global assessment of disease activity was measured on a visual analog scale (VAS) ranging from 0 (inactive) to 100 millimeter (mm) (extremely active). Results are reported by VAS scores observed for the participant's global assessment of RA activity: <=50 mm, >50-67 mm, >67-79 mm, >79 mm.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141280|NCT00459706|Secondary|Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. DAS28 includes a 28 tender joint count, a 28 swollen joint count, erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. Score ranged from 0 to 9.4. Interpretation: disease activity is low when score ≤3.2, moderate when 3.2<score≤5.1, or high when score >5.1, remission when score <2.6. Results are reported by categories of DAS28 score: <=4.7, >4.7-5.4, >5.4-6.2, >6.2.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141281|NCT00459706|Secondary|Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. Results are reported by duration of RA: <=3 years, >3-6 years, >6-13 years, >13 years.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141282|NCT00459706|Secondary|Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Participants were grouped into 2 categories: those who did and did not have prior self-injection experience. Higher scores indicated greater satisfaction in the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=evaluable participants for that category.||units on a scale||Standard Deviation|Mean
141283|NCT00459706|Secondary|Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction for the delivery mechanism. The 13-item short form of the PAM survey assessed participants' knowledge, skill, and confidence for self-management; calibrated scale score ranged from 0 to 100. Higher scores indicated more confidence in managing participants' condition and lifestyle. Results reported by PAM score: <=49.9, >49.9-56.4, >56.4-66, >66.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141284|NCT00459706|Secondary|Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, even-numbered questions related to depression. Responses scored on a 4-point scale; each question was graded in a different way. Depression subscale scores ranged from 0 to 21. Lower HAD Depression subscale scores indicated better health. Categories are depression subscale scores.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141285|NCT00459706|Secondary|Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. The HAD scale assessed participants' levels of anxiety and depression over the past week; total 14 questions, odd-numbered questions related to anxiety. Responses scored on a 4-point scale; each question was graded in a different way. Anxiety subscale scores ranged from 0 to 21. Lower HAD Anxiety subscale scores indicated better health. Categories are anxiety subscale scores.|Day 84|mITT; LOCF.||units on a scale||Standard Deviation|Mean
141286|NCT00459706|Secondary|Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Participants were categorized into those having only reading/writing capacity, those at the high-school/baccalaureate level, and those at the university level.|Day 84|mITT; LOCF. N=total participants with evaluable data. n=participants with evaluable data for that category.||units on a scale||Standard Deviation|Mean
141287|NCT00459706|Secondary|Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism.|Day 84|mITT; LOCF. N=total evaluable participants. n=participants evaluable in that category.||units on a scale||Standard Deviation|Mean
141288|NCT00459706|Secondary|Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept|Participant satisfaction scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher scores indicated greater satisfaction with the delivery mechanism. Results are reported by age categories: <=46 years, >46-55 years, >55-65 years, >65 years.|Day 84|mITT; last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
141289|NCT00459706|Secondary|Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 84|mITT. N=participants with evaluable data.||percentage of participants|||Number
141290|NCT00459706|Secondary|Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept|"Percentage of participants answering Yes to the question Are you satisfied with your injection device?"|Day 28|mITT. N=participants with evaluable data.||percentage of participants|||Number
141291|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Per-protocol (PP): mITT participants who completed the study with no major protocol violation. N=participants with evaluable data.||units on a scale||Standard Deviation|Mean
141292|NCT00459706|Primary|Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population|"Participant's response to the question How satisfied are you with your injection device? scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism."|Day 84|Modified Intent-to-Treat (mITT): All randomized participants who received at least 1 injection of test article and had at least 1 available evaluation after the first administration of test article. Number of participants analyzed (N) = participants with evaluable data.||units on a scale||Standard Deviation|Mean
141293|NCT00459667|Secondary|Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values|Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.|309 days|For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).||Percentage of participants|||Number
141294|NCT00459667|Primary|Hematological Abnormalities|"The variable Hematological abnormalities will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.||Percentage of participants|||Number
141295|NCT00459667|Primary|Liver Enzyme Elevations|"The variable Liver enzyme elevations will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.||Percentage of participants|||Number
141296|NCT00459667|Primary|Injection-site Reactions|"The variable Injection-site reactions will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.||Percentage of participants|||Number
141297|NCT00459667|Primary|Flu-like-syndrome|"The variable Flu-like-syndrome will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition."|309 days|The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.||Percentage of participants|||Number
141298|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Per-protocol population (PP) consisted of ITT patients who completed the study without protocol deviations that led to exclusion according to criteria defined before database lock The per-protocol population was used to provide confirmation of efficacy findings from the ITT population. Last Observation Carried Forward (LOCF).||Percentage of participants|||Number
141299|NCT00459537|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE or SAE and death. Additional details can be found in the Adverse Event Section.|Week 52|The Safety population consisted of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
141300|NCT00459537|Secondary|Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)||Percentage of participants|||Number
141301|NCT00459537|Secondary|Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 48 Weeks.|Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.|Week 52|Intent-to-treat population, Last Observation Carried Forward (LOCF)||Percentage of participants|||Number
141302|NCT00459537|Primary|Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks|Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|Week 52|The Intent-to-treat population (ITT) population consisted of all patients who were randomized and dispensed study drug. Last Observation Carried Forward (LOCF)||Percentage of participants|||Number
141303|NCT00459368|Secondary|Patient Medical Care Costs||1 year||||||
141304|NCT00459368|Secondary|Patient-physician Communication (Patient Reported Measure)||survey following intervention period||||||
141305|NCT00459368|Secondary|Readiness to Improve ICS Adherence (Transtheoretical Model)||survey following intervention period||||||
141306|NCT00459368|Secondary|Patient Self-efficacy to ICS Treatment||survey following intervention period||||||
141307|NCT00459368|Secondary|Oral Steroid Use||1 year||||||
141308|NCT00459368|Secondary|Asthma-related Hospitalizations||1 year||||||
141309|NCT00459368|Secondary|Asthma-related Emergency Room Visits||1 year||||||
141310|NCT00459368|Primary|Patient Adherence to Inhaled Corticosteroids (ICS)|Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.|1 year|||Percent of ICS medication taken||Standard Deviation|Mean
141311|NCT00459355|Primary|Caregiver Self-efficacy|Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence. The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.|3 months after baseline|||units on a scale||Standard Deviation|Mean
141312|NCT00459355|Secondary|Care Recipient Risky Behaviors and Accidents|The Risky Behavior Checklist listed common risky behaviors and accidents exhibited by care recipients with dementia based on previous research. Potential scores ranged from 0 - undetermined. The maximum score is undetermined because the measure represents the caregiver count of the number of times an incident occurred. In this study, sum scores ranged from 0 - 180.|3 months after baseline|||number of risky behaviors and accidents||Standard Deviation|Mean
141313|NCT00459355|Primary|Caregiver Strain|Caregiver Strain was measured by the MBRC Caregiver Strain Index; scores ranged from 0 - 15 with higher scores indicating more strain.|3 months after baseline|||units on a scale||Standard Deviation|Mean
141314|NCT00459342|Secondary|Time to Progression|Time in months from baseline assessment to disease progression or death for any reason, up to 5 years.|Up to 5 years||||||
141315|NCT00459342|Secondary|Overall Survival|Number of participants still living, measured from start of treatment to death from any cause, assessed up to 5 years using Kaplan-Meier.|Time from start of treatment to death from any cause, assessed up to 5 years||||||
141316|NCT00459342|Primary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death.|Time from start of treatment to time of progression or death, assessed at 2 months|Four participants were not evaluable for response.||months||95% Confidence Interval|Median
141317|NCT00459342|Primary|Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))|Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.|12 weeks|Of the 34 eligible study participants enrolled, four participants were not evaluable for response.||participants|||Number
141318|NCT00459316|Primary|Number of Participants With Immunogenicity at Step 3 Weeks 4 and 24|Immunogenicity was assessed by the number of participants with protective levels of antibody (titers greater than or equal to 1:128)|At Step 3 Weeks 4 and 24 post-booster vaccine|"Participants with data for Step 3 weeks 4 and 24. The numbers for Group 1 (1-dose), Group 1 (2-dose), and Group 3 respectively are:~Week 4: 73, 71, 37 Week 24: 73, 70, 33"||participants|||Number
141319|NCT00459316|Secondary|Safety, as Assessed by Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Step 3 Dose of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of vaccination at Step 3 entry through 6 weeks post-vaccination|All participants who were vaccinated at Step 3 entry||participants|||Number
141320|NCT00459316|Secondary|Immunologic Memory or Primary Response for Serogroup C by Treatment Arm|"Immunologic Memory defined as:~Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or~Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7.~Primary Response defined as:~A four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; or~A change from titer <1:128 on day 0 to titer ≥1:128on day 28, but not between day 0 and day 7."|At Week 4 post-booster vaccination|Group 1 participants who entered Step 3||participants|||Number
141321|NCT00459316|Secondary|Immunologic Memory for Serogroup C by Treatment Arm (1 vs. 2 Doses)|"Evidence of immunologic memory according to each of the following definitions:~Secondary (anamnestic) response defined as a four-fold rise in Ab titers between day 0 (booster dose) and day 7; or~Seroprotection on day 0 or change from titer <1:128 to titer ≥1:128 (seroprotection) between day 0 and day 7."|At Week 1 post-booster vaccination|Participants in Group 1 who entered Step 3||participants|||Number
141322|NCT00459316|Secondary|Number of Participants With Protective Antibody Titers for Serogroup C at Step 3 Entry|Number of participants with protective antibody titers (rSBA>=1:128) for serogroup C by treatment arm (1 vs. 2 doses) of Group 1 (entry CD4% >= 15) at Step 3 entry|At 3.5 years|Group 1 and 3 participants at entry to Step 3||participants|||Number
141323|NCT00459316|Secondary|Immunogenic Response to Serogroup C in Group 2|Immunogenic response as assessed by number of participants with protective antibody titers (>= 1:128) to serogroup C in Group 2 (entry CD4%<15)|At Weeks 4, 28, and 72|Group 2 participants with response data for weeks 4, 28 and 72||participants|||Number
141324|NCT00459316|Primary|Number of Participants With Primary Response (in Step 3)|Primary response was defined for each serogroup as a four-fold rise in Ab concentration between day 0 and day 28, but not between day 0 and day 7; OR a change from seronegative on day 0 to seropositive on day 28, but not between day 0 and day 7. Note: a primary response can only occur in the absence of any memory response.|Step 3 entry and Week 4 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.||participants|||Number
141325|NCT00459316|Primary|Number of Participants With Seropositive Memory Response (in Step 3)|Seropositive memory response was defined for each serogroup by having protective antibody levels (titer >= 1:128) on Day 0 or change from seronegative to seropositive between booster dose (Day 0) and Day 7.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.||participants|||Number
141326|NCT00459316|Primary|Number of Participants With 4-fold Memory Response in Step 3|Defined for each serogroup as a four-fold rise in antibody titers between booster dose (week 0) and week 1.|Step 3 entry and Week 1 post-booster vaccine|Because response is a combination of memory and primary response, only participants with data for weeks 0, 1 and 4 are included.||participants|||Number
145083|NCT00427635|Secondary|Change From Baseline in Number of Acidic Reflux Episodes|Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
141328|NCT00459316|Primary|Number of Participants With Reactions and Grade 3 or Higher Adverse Events Within 42 Days Following Dose 2 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 2 at week 24 to 6 weeks post-vaccination|All participants who entered Step 2||participants|||Number
141329|NCT00459316|Primary|Number of Participants With Grade 3 or Higher Adverse Events Within 42 Days Following Dose 1 of the Vaccine.|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.|From administration of Dose 1 at week 0 to 42 days post-vaccination|All participants who received Dose 1.||participants|||Number
141330|NCT00459316|Primary|Long-term Immunogenicity, as Assessed by Number of Participants With Protective Levels of Antibody at Week 72|Protective levels of antibody are titers ≥1:128.|Week 72|"Participants with antibody data at Week 72. The number of Participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:~serogroup A are 82, 108, 18, 44 serogroup C are 78, 110, 16, 44 serogroup W-135 are 80, 110, 17, 44 serogroup Y are 82, 110, 18, 44"||participants|||Number
141331|NCT00459316|Primary|Number of Participants With Short-term Immunogenicity, Defined as Number of Seroconverters at Week 4 (Those With at Least a 4-fold Rise in Meningococcal Serum Bactericidal Titers From Baseline)|Serum bactericidal antibody titers were measured at study entry and Week 4 for each of the four serogroups in the MCV-4 vaccine. Response (seroconversion) was defined as a 4-fold or greater increase from entry at Week 4.|At Study entry, Week 4|"This outcome only includes participants who had antibody data from both entry and Week 4.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 respectively are:~serogroup A are 93, 129, 20, 49 serogroup C are 90, 130, 18, 49 serogroup W-135 are 91, 131, 19, 49 serogroup Y are 93, 131, 20, 49"||participants|||Number
141332|NCT00459316|Primary|Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses of MCV-4.|Serum bactericidal antibody titers were measured at study entry and Week 28 for each of the four serogroups in the MCV-4 vaccine. Response was defined as a 4-fold or greater increase from entry at Week 28.|Study entry and Week 28|"This outcome only includes participants who received 2 doses and had antibody data from both entry and Week 28.The number of participants analyzed for Group 1 (15<CD4%<25), Group 1 (CD4%≥25), Group 2, Group 3 are respectively:~serogroup A: 49, 63, 20, 49 serogroup C: 47, 65, 18, 49 serogroup W-135: 47, 66, 19, 49 serogroup Y: 49, 66, 19, 49"||participants|||Number
141333|NCT00459303|Primary|Best Corrected Contrast Sensitivity in Photopic Condition|"Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the EYEVIEW™ Functional Analysis Software into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements.~( physiological range of contrast sensitivity: 1.5 cpd : 25~82.5 ; 3 cpd: 30~150 ; 6 cpd: 65 ~ 200 ; 12 cpd: 20 ~130 ; 18 cpd: 6.5 ~ 65 )"|average data of post-operative 3rd week, 6th week, 12th week measurements|||units on a scale||Standard Deviation|Mean
141334|NCT00459303|Secondary|Total Ocular High-order Aberrations|A Hartmann-Shack aberrometer (Zywave, Bausch & Lomb Inc., Rochester, New York ) was used for measurement of HOAs of the whole eye. The measurements were done under maximal mydriasis with Mydrin-P (phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen). The wavefront errors were described using the RMS of Zernike polynomials for total HOA at pupil diameters of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at the pupil diameter of 6 mm.|average data of post-op 3rd, 6th, 12th week measurements|||μm||Standard Deviation|Mean
141335|NCT00459303|Secondary|Corneal High-order Aberrations|Corneal topography was performed with a TMS-4 corneal tomographer (Tomey, Japan). We used the 31-rings placido-based system that covers 10.9 mm of corneal diameter which is sufficient for the study of aberrations up to the fifth order for 6 mm diameter. Corneal HOAs were described with Zernike polynomials of 3rd- to 5th-order root-mean-square (RMS) of central 6mm diameter using VOLPro 6.89 software (Fa. Sarver and Associates, Carbondale. Ill, USA).|pre-op & averate data of post-op 3rd, 6th, 12th week measurements|||μm||Standard Deviation|Mean
141336|NCT00459303|Primary|Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition|Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.|average data of post-op 3rd, 6th, 12th week measurements|"we obtained data and calculated the probable sample size needed from the following reference papers:~Ophthalmologe 2005 Jan;102(1):51-7.~Acta Ophthalmol Scand 2004;82(6):718-22."||log MAR||Standard Deviation|Mean
141347|NCT00459134|Secondary|Quality of Life|Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.|12 weeks|Participants who filled out the FACT-G at any time||units on a scale||Standard Error|Least Squares Mean
152425|NCT00365846|Secondary|Incidence of Post-transplant Infection|"Event of post-transplant infection (more than one event might have been counted per participant)"|3 years|||event of infection|||Number
141337|NCT00459290|Secondary|Progression-free Survival by Age (y)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
141338|NCT00459290|Secondary|Progression-free Survival by Performance Status||Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
141339|NCT00459290|Secondary|Progression-free Survival by Platinum Sensitivity|Platinum Senstive defined as treatment free interval >6 months on most recent platinum|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants with treatment free interval available||months||95% Confidence Interval|Median
141340|NCT00459290|Secondary|Overall Survival||Five years|Eligible and treated participants||months||95% Confidence Interval|Median
141341|NCT00459290|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||months||95% Confidence Interval|Median
141342|NCT00459290|Primary|Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0||Every cycle, during treatment.||||||
141343|NCT00459290|Primary|Proportion of Patients With Objective Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||percentage of participants||95% Confidence Interval|Number
141344|NCT00459290|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants||percentage of participants||95% Confidence Interval|Number
141345|NCT00459186|Secondary|Response Based on PET Scan|Patients were scanned using Positron Emission Tomography (PET) before and after receiving single agent RAD001. Patients were classified as having partial metabolic response, stable metabolic disease, or progressive metabolic disease based on changes in PET imaging from baseline to post-treatment. A positive FDG-PET for the purposes of this study consisted of a visualized area of abnormal increased FDG uptake that matched the anatomic location of an abnormality seen on bone scan or CT. Metabolic response was assessed for percent change in SUVmax according to the criteria of the European Organization for Research and Treatment of Cancer (EORTC) : partial metabolic response (PMR) ≤ -25%; stable metabolic disease (SMD) -25% + 25%; progressive metabolic disease (PMD) > 25%.|10 to 14 days after study entry|All patients receiving at least one dose of RAD001||percentage of participants||90% Confidence Interval|Number
141346|NCT00459186|Primary|Number of Patients Free of Dose Limiting Toxicity|"A dose limiting toxicity was defined as an adverse event or laboratory abnormality that occurs to patients on the Phase I portion of the trial, during the first 21 days following the first dose of RAD001/docetaxel during cycle 1, judged to be related to RAD001/docetaxel and meeting any of the following criteria:~Hematologic Toxicity:~CTCAE grade 4 neutropenia > 7 days or any Grade 3 or 4 neutropenia with fever Or CTCAE grade 3 or 4 thrombocytopenia > 7 days~Non-hematologic toxicity:~The occurrence of non-hematologic CTCAE grade 3 or 4 adverse events will be considered dose limiting, except for the following:~CTCAE grade 3 nausea or grade 3 or 4 vomiting CTCAE grade 3 or 4 vomiting will only be considered dose limiting if it occurs despite the use of standard anti-emetics.~CTCAE grade 3 or 4 fever identified with a source (i.e. infection, tumor)~CTCAE grade 3 or 4 alkaline phosphatase."|21 days|Patients who received combination treatment with RAD001 + Docetaxel||participants|||Number
141371|NCT00458406|Secondary|Pediatric Quality of Life (PedQL)||3 months||||||
141348|NCT00459134|Primary|Sexual Function|Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.|12 weeks|Participants who filled out the FSFI at any time||units on a scale||Standard Error|Least Squares Mean
141349|NCT00459121|Secondary|Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.|Evaluation of the number of patients who have no evidence of tumor in the resected tumor.|30 days post surgery||||||
141350|NCT00459121|Secondary|Assess the Clinical Response Rate of the Proposed Pre-operative Regimen|Patients will undergo tumor evaluation when all of the three cycles have been completed unless the treating physician has concerns regarding tumor progression. If the patient has undergone tumor evaluation prior to the last cycle the patient will require repeat tumor assessment within 4 weeks of completion of the last cycle of therapy|End of three cycles of treatment||||||
141351|NCT00459121|Secondary|Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy|Serum chemistry includes Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, potassium, total protein, SGOT [AST], SGPT [ALT], sodium, laboratory tests should be done on a weekly basis for the first cycle. After the first cycle laboratory tests should be done within 72 hours of each dose of carboplatin/paclitaxel.|Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel||||||
141352|NCT00459121|Secondary|Post-Operative Mortality Rate||at 30 days||||||
141353|NCT00459121|Primary|Complete Resection (R0) Rate||Following three cycles of pre-operative zactima and carboplatin/paclitaxel|No analysis will be completed.|||||
141354|NCT00459108|Secondary|Safety and Tolerability||Up to 4 years||||||
141355|NCT00459108|Secondary|Overall Survival||Up to 4 years||||||
141356|NCT00459108|Secondary|Median PFS||Up to 4 years||||||
141357|NCT00459108|Primary|Four Month Progression-free Survival (PFS)|Progression-free survival calculated using the method of Kaplan-Meier.|4 months|||participants progression-free after 4 mo|||Number
141358|NCT00459108|Primary|Response Rate (Complete and Partial Response)|Patients with confirmed partial or complete response using the RECIST criteria.|4 months|||percentage of responding patients|||Number
141359|NCT00459056|Primary|Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ)|Reactive hyperemic index is a measure of endothelial function. This is measured by the ratio of post-occlusion blood volume flow versus the baseline blood volume flow. The outcome reported is the change in this ratio after the first intervention phase compared to after the second intervention phase.|Change from three months to seven months|All completers were included in the analysis||Ratio||Standard Deviation|Mean
141360|NCT00459043|Secondary|Overall Survival||3 years|||weeks||95% Confidence Interval|Median
141361|NCT00459043|Secondary|Progression Free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sumof the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions|3 years|||weeks||95% Confidence Interval|Median
141362|NCT00459043|Primary|Partial Response Rate in Both Groups of Patients.|Objective tumor response was evaluated radiogically using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. For target lesions: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diamter of target lesions; Overall Response (OR) = CR+PR|3 years|29 patients were analyzable||percentage of participants||95% Confidence Interval|Number
141363|NCT00458952|Primary|MTD of Ultratrace Iobenguane I 131|Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.|6 weeks post therapy dose|24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in this trial. Of the 24 consenting patients, 21 patients were administered Ultratrace iobenguane I 131. Three patients did not meet all the inclusion and exclusion criteria, and were not allowed into the study.||mCi/kg|||Number
141364|NCT00458822|Primary|Hematologic and Organ Response|patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.|2-3 months post transplant|||participants|||Number
141365|NCT00458705|Primary|Disease Response|The response of myeloma to BDDTD will be assessed by standard electrophoretic and immunofixation tests of blood and urine for a monoclonal protein (M protein), and bone marrow aspirate and biopsy. These tests will be performed at enrollment and at the conclusion of therapy.|2 years|||participants|||Number
141366|NCT00458536|Secondary|to Correlate Immunologic Response Following Vaccination.||5 years||||||
141367|NCT00458536|Secondary|To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and GM-CSF||5 years||||||
141368|NCT00458536|Primary|Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF||5 years|Adverse events potentially related to vaccination were largely restricted to injection site reactions. 12 of the 19 patients experienced vaccine site reactions.||participants|||Number
141369|NCT00458406|Primary|Change in Minutes of Use Per Night From Month 1 to Month 3|minutes of use per night at Month 3 minus minutes of use per night at Month 1|month 1, month 3|||minutes||Standard Deviation|Mean
141370|NCT00458406|Primary|Minutes of Use Per Night at Month 3|The number of minutes of use per night at Month 3.|3 Months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||minutes||Standard Deviation|Mean
141373|NCT00458406|Secondary|Change in ESS From Month 1 to Month 3|Change in the Epworth Sleepiness Scale (ESS) score from Month 1 to Month 3: (Score at Month 3 minus Score at Month 1). The ESS measures daytime sleepiness in certain situations e.g. sitting/reading, watching television, sitting inactive in public, as a passenger in a car for an hour without a break, lying down to rest in the afternoon when circumstances permit, sitting/talking with someone, sitting quietly after lunch, or in a car, while stopped for a few minutes in traffic. The scale ranges from a minimum of zero to 24, with higher scores indicating greater daytime sleepiness.|3 months|||units on a scale||Standard Deviation|Mean
141374|NCT00458406|Secondary|Obstructive Sleep Apnea (OSA) 18 Score||3 months||||||
141375|NCT00458406|Secondary|Change in Apnea Hypopnea Index (AHI; Number of Apneas and Hypopneas Per Hour of Sleep) From Month 1 to Month 3|Change in Apnea Hypopnea Index from Month 1 to Month 3. AHI at Month 3 minus AHI at Month 1.|3 months|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||Apneas and Hypopneas/hr sleep||Full Range|Median
141376|NCT00458406|Secondary|Drop Out Rate|Number of drop-outs included subjects in which investigators were unable to obtain a final download from the device.|3 months|Power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||participants|||Number
141377|NCT00458406|Primary|Minutes of Use Per Night at Month 1|The number of minutes of use per night at month 1.|1 month|The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||minutes||Standard Deviation|Mean
141378|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Social Well-Being Subscale|The FAHI social well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
141379|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Physical Well-Being Subscale|The FAHI physical well-being subscale. Each item is assessing the impact of HIV on physical well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
141380|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Functional and Global Well-Being Subscale|The FAHI functional and global well-being subscale. Each item is assessing the impact of HIV on functional and global well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
141381|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Emotional Well-Being Subscale|The FAHI emotional well-being subscale. Each item is assessing the impact of HIV on emotional well-being on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
141382|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Cognitive Function Subscale|The FAHI cognitive function subscale. Each item is assessing the impact of HIV on cognitive function on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
141383|NCT00458302|Secondary|Change From Baseline in Health-Related Quality of Life - FAHI Questionnaire Total Score|The FAHI is a validated health-related quality of life questionnaire. The questionnaire consist of 44 items and includes 5 functional scales (physical, social, emotional, functional and global well-being and cognitive function). Each item is assessing the impact of HIV on a scale from 0 (not at all) to 5 (very much).|at baseline, week 48, 96 and 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of protocol adherence. A LOCF method was used for calculation.||points on a scale||Standard Error|Mean
141384|NCT00458302|Secondary|Resistance Determinations|Number of patients with resistance mutations at any time point when a patient had a viral load > 50 copies/mL after randomization.|at each visit from baseline to week 144|ITT: all randomised patients who had at least 1 dose of study medication, regardless of their adherence to the protocol.||number of participants|||Number
141385|NCT00458302|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at week 4, 12, 24, 36, 48, 60, 72, 84, 96, 112, 128, 144|ITT: all randomized patients who had at least 1 dose of study medication, regardless of their adherence to the protocol||number of cells/L (x10^6)||Standard Error|Mean
141386|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, <200 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 200 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|week 144|PP population: all randomised patients who took study drug, and who did not deviate from the protocol. This excludes 13 patients with major protocol deviations.||Participants|||Number
141408|NCT00458211|Primary|Positive and Negative Syndrome Scale (PANSS) Measuring Symptoms of Schizophrenia|Minimum score 32 (best) maximum 210 (worst)|Baseline to 8 weeks|The four Rochester subjects were dropped as Rochester could not continue the study.19 Bronx and 17 Buffalo subjects were analyzed separately because they were so different(see baseline characteristics)||score on scale||Standard Deviation|Mean
141387|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT), TLOVR - All Switches Included, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). All switches included means that all data even after any changes of treatment were kept. *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 144 window.|Week 144|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.||participants|||Number
141388|NCT00458302|Secondary|Virological Response [Per Protocol (PP), TLOVR - Switch Equals Failure, < 50 Copies/ml, Week 144]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 144. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 144|Week 144|PP population: all randomised subjects who took study drug, and who did not deviate from the protocol.This excludes 13 subjects with major protocol deviations.||participants|||Number
141389|NCT00458302|Secondary|Virological Response [Intent To Treat (ITT) - TLOVR, < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the ITT population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until start of Week 48 window|Week 48|ITT population: all randomised patients who took study drug, regardless of their compliance with the protocol.||participants|||Number
141390|NCT00458302|Primary|Virological Response [Per Protocol (PP) - Time to Loss of Virologic Response (TLOVR), < 50 Copies/ml, Week 48]|Virological response is defined as the number of patients in the PP population with a plasma viral load < 50 HIV RNA copies/ml at Week 48. Treatment failure was defined as two consecutive HIV RNA levels ≥ 50 copies/mL, or discontinuation of randomised treatment (known as TLOVR). In addition, any switch in background nucleoside reverse transcriptase inhibitors (NRTIs) equaled failure* (referred to as a Switch Equals Failure analysis). *Discontinuations and rechallenge with NRTIs are taken into account until Week 48|Week 48|PP population: all randomised patients who took study drug, and who did not deviate from the protocol.This excludes 10 patients with major protocol deviations.||participants|||Number
141391|NCT00458237|Secondary|Clinical Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall clinical response defined as achieving stable disease (SD), partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response. SD is neither CR/PR or progressive disease (PD). PD is at least a 20% increase in sum LD, takings as reference smallest sum LD since treatment started.|Disease assessments occurred every 9 weeks (3 cycles) on treatment. Treatment continued until disease progression or unacceptable toxicity. Median duration of treatment was 2.4 months.|The analysis dataset is comprised of patients treated at the MTD/dose level 2.||proportion of participants||90% Confidence Interval|Number
141392|NCT00458237|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0):~Any grade 4 hematologic toxicity, excluding anemia.~Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within 24 hours for nausea, vomiting, and diarrhea and within 1 week for hyperlipidemia) to appropriate treatment, and except for cardiac toxicity which will be assessed after 12 weeks of treatment.~Need to hold >1 dose of trastuzumab or > 7 doses of RAD001 within the first 3 weeks because of the presence of toxicity."|Cycle One (first 21 days of treatment)|The analysis dataset for the Phase I study is comprised of the two dose cohorts: Level 1 and 2.||participants with DLT|||Number
141393|NCT00458211|Secondary|Antipsychotic Medication Costs||8 weeks||||||
141394|NCT00458211|Secondary|Insulin Level||8 weeks||||||
141395|NCT00458211|Secondary|HgbA1c||8 weeks||||||
141396|NCT00458211|Secondary|Barnes Akathisia Scale||8 weeks||||||
141397|NCT00458211|Secondary|MOS-COG||8 weeks||||||
141398|NCT00458211|Secondary|PETiT||8 weeks||||||
141399|NCT00458211|Secondary|CDSS||8 weeks||||||
141400|NCT00458211|Secondary|BACS||8 weeks||||||
141401|NCT00458211|Secondary|QTc|Time interval between Q and T waves on EKG corrected for pulse rate. Over 500 msec may be dangerous|8 weeks|||msec||Standard Deviation|Mean
141402|NCT00458211|Secondary|Simpson-Angus Scale Measures Drug Induced Parkinsonism|Measures 10 signs, (not all of which are now considered Parkinsonism), minimum score 0 (no Parkinsonism) maximum 40.|8 weeks|see PANNS above||score on scale||Standard Deviation|Mean
141403|NCT00458211|Secondary|Abnormal Involuntary Movement Scale (AIMS) Measures Tardive Dyskinesia|Scores 0 (none) to 4 (severe) choreo-athetoid and dystonic movements of seven parts of the body with a maximum score 28|8 weeks|17 Buffalo subjects and 19 Bronx subjects||score on scale||Standard Deviation|Mean
141404|NCT00458211|Secondary|Cholesterol||8 weeks|See PANSS above||mg/dL||Standard Deviation|Mean
141405|NCT00458211|Secondary|Fasting Glucose||8 weeks|See PANNS above||mg/dl||Standard Deviation|Mean
141406|NCT00458211|Secondary|Weight||8 weeks|Same as PANNS above||pounds||Standard Deviation|Mean
141407|NCT00458211|Secondary|Clinical Global Impression (CGI) Scores the Evaluator's Overall Impression of Severity (CGI-S) or Change (CGI-I) in Illness.|CGI-S scores from 1 = normal to 7 = most extremely ill|8 weeks|17 Buffalo subjects and 19 Bronx subjects||score on scale||Standard Deviation|Mean
141409|NCT00457977|Secondary|Serotype-specific Immunoglobulin G (IgG) Antibody Levels|Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)|Measured at Baseline, Months 1, 12, and 24|All participants with blood samples were analyzed.||ug/ml||95% Confidence Interval|Geometric Mean
141411|NCT00457951|Primary|Incidence of Treatment Failure|"The primary outcome of the study is Treatment Failure as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital."|Time to hospital discharge and 21 days post-treatment, up to 31 days|Of the 138 subjects randomized, 132 were analyzed in the intent-to-treat population. Of the 6 excluded from the intent-to-treat population, 4 did not receive study drug and 2 lacked information for assessment.||percentage of failures||95% Confidence Interval|Number
141412|NCT00457821|Primary|Number of Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||events|||Number
141413|NCT00457821|Secondary|Change From Baseline in Maximum Sweat Chloride Concentration (Combined Part 1 and Part 2)|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.||millimoles per liter||95% Confidence Interval|Least Squares Mean
141414|NCT00457821|Secondary|Change From Baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score (Part 2 Only)(Respiratory Domain Score)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|14 days and 28 days|Part 2 is a parallel study. Subjects were counted only once for each treatment group.||score on a scale||Standard Deviation|Mean
141415|NCT00457821|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second [FEV1] (Combined Part 1 and Part 2)|"Spirometry is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.~Relative change reflects the percent change from the baseline values [100% * (X-Y)/Y], where X and Y are post-baseline and baseline values, respectively."|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.||percent predicted (%)||95% Confidence Interval|Least Squares Mean
141416|NCT00457821|Secondary|Change From Baseline in Nasal Potential Difference (Combined Part 1 and Part 2)|The transepithelial nasal potential difference (NPD) is a direct measure of transepithelial ion transport. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol was of primary interest.|14 days and 28 days|Due to the crossover design in Part 1, subjects were counted once for each period; therefore, the 4 unique subjects who received placebo were counted as 8 subjects in the analyses for Part 1.||millivolts||95% Confidence Interval|Least Squares Mean
141417|NCT00457821|Primary|Number of Subjects With Adverse Events (Combined Part 1 and Part 2)|Adverse event data were collected up to the follow-up visit (5 to 9 days after last dose of study drug). Serious adverse events that were ongoing at the follow-up visit were followed until the event resolved, returned to baseline, or was determined to be a stable or chronic condition.|Baseline to Follow-up|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).||participants|||Number
141418|NCT00457795|Secondary|Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4|Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
141419|NCT00457795|Secondary|Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4|Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
141420|NCT00457795|Secondary|Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.|Baseline, Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
141421|NCT00457795|Primary|Intraocular Pressure (IOP) for a 24-Hour Period at Week 4|IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.|Week 4|Intent to Treat defined as all patients who started the study (randomized)||Millimeters of mercury (mmHg)||Standard Deviation|Mean
141422|NCT00457743|Secondary|Overall Survival Time|"Overall Survival Time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, Overall Survival Time was censored on the last date when the patient was known to be alive.~Survival was surveyed once a year from the registration day of the first subject, for all the subjects who received the study drug at least once."|From the first dose to death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
141423|NCT00457743|Secondary|Time To Failure (TTF)|Time To Failure (TTF) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer.|From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
141424|NCT00457743|Primary|Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group|Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
141425|NCT00457743|Primary|Accumulation Ratio (Rac) on Cycle 1 Day 28|"Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1.~Rac was the ratio of Day 28 to Day 1."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||ratio||Standard Deviation|Mean
141426|NCT00457743|Primary|SU-011248 Clearance on Cycle 1 Day 28|"SU-011248 Clearance in the subjects enrolled in Phase 1.~Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||L/h||Standard Deviation|Mean
141427|NCT00457743|Secondary|Progression-Free Survival (PFS)|Progression-Free Survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD) or death.|From the first dose to Progressive Disease or Death|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
141428|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||hours||Full Range|Median
141429|NCT00457743|Primary|Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1|"Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.||hours||Full Range|Median
141430|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75-mg dose group discontinued the dose on Cycle1, therefore no data showed."||ng•h/mL||Standard Deviation|Mean
141431|NCT00457743|Primary|Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1|"Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.||ng•h/mL||Standard Deviation|Mean
141432|NCT00457743|Secondary|Time To Tumor Progression (TTP)|Time To tumor Progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of Progressive Disease (PD).|From the first dose to Progressive Disease|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
141433|NCT00457743|Secondary|Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Objective Response is defined as sum of the subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|ITT population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
141434|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 28 of Cycle 1|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~3 subjects in 75mg dose group discontinued before Cycle 1 Day 28, therefore no data presented."||ng/mL||Standard Deviation|Mean
141570|NCT00456625|Secondary|Number of Participants Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to 1 month after the challenge dose.|||participants|||Number
141435|NCT00457743|Secondary|Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group|Number of subjects with Disease Controlled is defined as sum of the subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)>= 10 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
141436|NCT00457743|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires|"The EQ-5D questionnaires evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale(1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index. High score is indicating high health.~Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline"|Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n= Number of subjects with analyzable data."||index scores on a scale||Standard Deviation|Mean
141437|NCT00457743|Secondary|Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires|"Patient-reported outcome: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaires (version 4A).~The questionnaire consists of a 13-item subscale which covers specific fatigue questions. The subject rates the intensity of fatigue and its related symptoms on a five-point scale(0 to 4). High score is indicating low fatigue. The total score of the 13 items was evaluated.~Change from Baseline: Score at each observation minus score at baseline"|Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n= Number of subjects with analyzable data."||scores on a scale||Standard Deviation|Mean
141438|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."||ng/mL||Standard Deviation|Mean
141439|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-012262|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."||ng/mL||Standard Deviation|Mean
141440|NCT00457743|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.~n= Number of subjects with analyzable data."||ng/mL||Standard Deviation|Mean
141441|NCT00457743|Secondary|Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)|Plasma concentrations of potential pharmacodynamic markers; Soluble Stem Cell Factor Receptor (sKIT)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."||pg/mL||Standard Deviation|Mean
141442|NCT00457743|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."||pg/mL||Standard Deviation|Mean
141443|NCT00457743|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Day 1, 14, 28 of Cycles 1-4|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacodynamics analysis.~n= Number of subjects with analyzable data."||pg/mL||Standard Deviation|Mean
141444|NCT00457743|Primary|Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1|"Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1.~The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662)."|Day 1 of Cycle 1|All enrolled subjects who received at least 1 dose of study medication and who had at least 1 blood concentration data for Pharmacokinetic analysis.||ng/mL||Standard Deviation|Mean
141445|NCT00457743|Primary|Number of Subjects With Dose Limiting Toxicities (DLT)|Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.|Cycle 1 (Baseline to Week 6)|DLT analysis population consists of subjects who developed DLT or received 85% of the planned dose. One subject in 75-mg dose group was excluded from DLT analysis population because the subject received less than 85% of the planned dose.||participants|||Number
141446|NCT00457730|Secondary|Global Impression of Change|"global impression: How do you feel about the effects of the medication over the past 7 days? 7 point scale, 7 = delighted, 1= terrible"|Week 6 vs baseline|||units on a scale||Standard Deviation|Mean
141447|NCT00457730|Secondary|Percent Change in Average Pain Score.|Percent change in Weekly mean of 24 hour Average pain Score, Week 6 vs. baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6|||percent reduction on 0-10 analog scale||Standard Deviation|Mean
141448|NCT00457730|Primary|Percent Change in Worst Pain Score|Weekly mean of 24 hour Worst Pain Score, percent change from baseline. Range is 0-10 with 0= no pain and 10= worst possible pain.|at week 6|||percent reduction on 0-10 analog scale||Standard Deviation|Mean
141461|NCT00456521|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
152426|NCT00365846|Secondary|Patient Survival||3 years|||participants|||Number
141449|NCT00457691|Secondary|Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline scores for EQ-VAS were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).||Scores on a scale||95% Confidence Interval|Mean
141450|NCT00457691|Secondary|Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire|"EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state."|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The EQ-5D health state index results were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).||Scores on a scale||95% Confidence Interval|Mean
141451|NCT00457691|Secondary|Change From Baseline in MDASI-GI Symptom Interference Score|Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, 11).||scores on a scale||95% Confidence Interval|Mean
141452|NCT00457691|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score|Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).|Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal|ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, and 11).||Scores on a scale||95% Confidence Interval|Mean
141453|NCT00457691|Secondary|Duration of Response (DR)|DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.|Day 28 of Cycle 1 up to 30 months|ITT Population (participants with a confirmed objective tumor response).||Weeks||95% Confidence Interval|Median
141454|NCT00457691|Secondary|Number of Participants With Overall Confirmed Objective Response|Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 30 months|||Participants|||Number
141455|NCT00457691|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.|Baseline up to 30 months|ITT Population.||Weeks||95% Confidence Interval|Median
141456|NCT00457691|Primary|Progression-free Survival (PFS)|PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.|First dose of study treatment up to 30 months|Intent-to-treat (ITT) population included all participants who were randomized.||Weeks||95% Confidence Interval|Median
141457|NCT00456547|Secondary|Antithrombin III Levels at 2 Hours Post Delivery|Antithrombin III is a glycoprotein and is the major inhibitor of thrombin and other activated clotting factors, including factors IX, X, XI, and XII, the cofactor through which heparin exerts its effect. We hypothesized that women with continued bleed following delivery and require a hysterectomy will demonstrate a greater reduction in antithrombin III that women undergoing cesarean delivery.|2 hours after delivery|||percentage of normal antithrombin III||Standard Deviation|Mean
141458|NCT00456547|Secondary|Plasminogen Levels 2 Hours After Delivery|Plasminogen is converted to plasmin when the coagulation system is activated. We hypothesized that plasminogen should be decrease more in women with continued bleeding following delivery requiring hysterectomy will demonstrated a greater decrease in plasminogen than following cesarean delivery.|2 hours after delivery|||mg/dL||Standard Deviation|Mean
141459|NCT00456547|Secondary|Platelet Counts at 2 Hours After Delivery|Platelets are decreased in subjects with consumptive coagulopathies which is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases. We hypothesized that women who require hysterectomy for postpartum bleeding are more likely to have decreased platelet counts than matched controls that underwent cesarean delivery.|2 hours after delivery|||platelets (*1000 per liter)||Standard Deviation|Mean
141460|NCT00456547|Primary|Fibrinogen Level at 2 Hours After Delivery|Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.|2 hours after delivery|||mg/dL||Standard Deviation|Mean
142644|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||participants|||Number
141462|NCT00456521|Secondary|Change in Food Craving Inventory Carbohydrates Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
141463|NCT00456521|Secondary|Change in Food Craving Inventory Sweets Subscale Scores|The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
141464|NCT00456521|Secondary|Change in IDS-SR Total Scores|IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
141465|NCT00456521|Secondary|Change in Diastolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mmHg||Standard Error|Least Squares Mean
141466|NCT00456521|Secondary|Change in Systolic Blood Pressure||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mmHg||Standard Error|Least Squares Mean
141467|NCT00456521|Secondary|Change in Fasting LDL Cholesterol||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
141468|NCT00456521|Secondary|Change in Fasting Blood Glucose Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
141469|NCT00456521|Secondary|Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
141470|NCT00456521|Secondary|Change in HOMA-IR Levels, Using Log-transformed Data|HOMA-IR= Homeostasis Model Assessment-Insulin Resistance|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
141471|NCT00456521|Secondary|Change in IWQOL-Lite Total Scores|IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment|Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||units on a scale||Standard Error|Least Squares Mean
141472|NCT00456521|Secondary|Change in Fasting HDL Cholesterol Levels||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||mg/dL||Standard Error|Least Squares Mean
141473|NCT00456521|Secondary|Change in Fasting Insulin Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
141474|NCT00456521|Secondary|Change in Fasting Triglycerides Levels, Using Log-transformed Data||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percent change||95% Confidence Interval|Least Squares Mean
141475|NCT00456521|Secondary|Change in Waist Circumference||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||cm||Standard Error|Least Squares Mean
141476|NCT00456521|Secondary|Body Weight- Proportion of Subjects With ≥10% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
141477|NCT00456521|Primary|Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease||Baseline, 56 weeks|Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method.||percentage of participants||95% Confidence Interval|Number
141479|NCT00456508|Secondary|Time to Significant Improvement|"Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of a lot better or resolved in the overall response assessment."|15 min - 4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.||estimated time in minutes||95% Confidence Interval|Median
141480|NCT00456508|Secondary|Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms|The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score.||scores on a scale||Standard Deviation|Mean
141481|NCT00456508|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing|Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|4 hrs post dose after every episode|All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in MSCS score.||scores on a scale||Standard Deviation|Mean
141482|NCT00456495|Secondary|Regression of Blood Vessels|To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate the number of clock hours of corneal neovascularization, from baseline to month 12, and 24. To report on the number of patients with a decrease in corneal neovascularization.|2 years||09/2012||||
141483|NCT00456495|Secondary|Evaluating Tumor Destruction or Reduction|To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.|2 years||09/2012||||
141484|NCT00456495|Primary|Number of Patients Assessed for Safety and Tolerability|To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).|2 years|Analysis was per protocol. Treatment was delivered every 2-4 weeks.||participants|||Number
141485|NCT00457418|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) was defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, whether or not considered related to the use of that product.|Entire study duration (up to 5 years)|||participants|||Number
141486|NCT00457418|Primary|Apparent Clearance(CL/F) of PEG-Intron at 12 Weeks|CL/F was defined apparent clearance - the volume of plasma in the vascular compartment cleared of drug per unit of time and per kilogram of body weight by the processes of metabolism and excretion.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 15 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification but for 5 participants CL/F could not be reported because t1/2 could not be accurately determined).||L/hr/kg||Standard Deviation|Mean
141487|NCT00457418|Primary|Observed Time to Achieve Cmax (Tmax) of PEG-Intron at 12 Weeks|Tmax was defined as time of maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose).||hours||Full Range|Median
141488|NCT00457418|Primary|Minimum Serum Concentration (Cmin) of PEG-Intron at 12 Weeks|Cmin was defined as observed minimum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|There were 19 evaluable participants (20 participants completed the full 12 weeks of treatment without any significant dose modification and there was no concentration data for 1 participant at Week 12).||pg/mL||Standard Deviation|Mean
141489|NCT00457418|Primary|Average Concentration Within the Dosing Interval (Cavg) of PEG-Intron at 12 Weeks|Cavg was defined as average plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)||pg/mL||Standard Deviation|Mean
141490|NCT00457418|Primary|Maximum Serum Concentration (Cmax) of PEG-Intron at 12 Weeks|Cmax was defined as observed maximum plasma concentration.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)||pg/mL||Standard Deviation|Mean
141491|NCT00457418|Primary|Area Under the Curve (AUC) of PEG-Intron at 12 Weeks|AUC was defined as the actual body exposure to drug after administration of a dose of the drug.|Predose, and 24, 48, 72, 96, and 168 hours postdose at 12 weeks|Participants who completed the full 12 weeks of treatment without any significant dose modification (dose reduction or missing dose)||pg*hr/mL||Standard Deviation|Mean
141566|NCT00456807|Primary|Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18|"The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.~An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification."|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||cells per million B-cells||95% Confidence Interval|Geometric Mean
141492|NCT00457392|Secondary|EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state."|Baseline and End of Treatment (EOT) or Withdrawal|Patients Reported Outcome (PRO) Analysis Set included participants from the FA population who had at least one EQ-5D assessment while on treatment. The 'n' signifies those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Deviation|Mean
141493|NCT00457392|Secondary|One-year Survival Probability|The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate.|Baseline until death or until 28 days after last dose for the last participant|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Percent chance of survival||95% Confidence Interval|Number
141494|NCT00457392|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.|Baseline to disease progression or death or discontinuation from study or 28 days after last dose|DR was calculated for the subgroup of participants from the FA set, with a confirmed objective tumor response.||Weeks||95% Confidence Interval|Median
141495|NCT00457392|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline to disease progression or discontinuation from study or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Percentage of participants||95% Confidence Interval|Number
141496|NCT00457392|Secondary|Progression-Free Survival (PFS)|"Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause or 28 days after last dose|The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Weeks||95% Confidence Interval|Median
141497|NCT00457392|Primary|Overall Survival (OS)|Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline to death or 28 days after last dose for the last participant|The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.||Months||95% Confidence Interval|Median
141498|NCT00457301|Primary|EuroQol, EQ-5D.|Generic preference-based measure. EQ-5D consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (“no problem”, “some problems” and “extreme problems”).Using the US scoring function EQ-5D index scores range from -0.11 (all-worst health state, worse than dead), to 0.00 (dead) to 1.00 (perfect health). The EQ-5D is easy to complete, valid and reliable.|At baseline and end of study (6 months).|To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error, two-sided-test and 80% power. ITT was conducted for 213 recruited patients. 47 records were imputed using LOCF.||mean EQ-5D index score||Standard Deviation|Mean
141499|NCT00457301|Primary|Management Composite|Changes in clinical management were recorded in the chart review form. The number of referrals to other healthcare providers, tests ordered (X-rays, blood test, bronchoscopies) and changes in medication (reduction or increase dosage, addition or discontinuation) were summed to produce the management composite.|At baseline and end of study (6 months)|Analysis was conducted using ITT, with 47 observations carried forward.||mean management composite||Standard Deviation|Mean
141500|NCT00457301|Secondary|The Hospital Anxiety and Depression Scale,HADS. Completed at Baseline and End of the Study.|HADS is a self-complete mental health measure. The scale consists of 14 items, seven of which assess anxiety and seven which assess depression. Each item is on a four point scale and the scores are added to give a total ranging from 0 to 21 for anxiety and 0 to 21 for depression. Higher scores indicate more severe anxiety or depression. A cut-point of 8 or 9 indicates mild burden for the two scales; 11 or 12 indicates severe . All the patients completed HADS at baseline and at the end of the study.|Baseline and end of study (6 months)|47 observation were imputed by LOCF and analyzed as ITT.||mean anxiety and depression||Standard Deviation|Mean
141868|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution at Steady State (Vss/F/Dose) on Day 28|Volume of distribution at steady state (Vss/F/Dose) were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment|||mL/mg||Full Range|Median
141501|NCT00457301|Primary|Communication Score|Each clinician-patient encounter was audio tape-recorded. The content of the tape-recordings was examined and results recorded on the communication form by three blinded raters. This form tallies the number of issues discussed. The number of issues is summed to produce a communication score. The issues discussed included health attributes included in the HUI2 and HUI3: ambulation, self-care, anxiety, depression, cognitive problems, pain (type and frequency), vision, hearing speech and dexterity problems.|Baseline and end of study (6 months)|Traditional analysis of covariance, ANCOVA was conducted to explore the difference between control and intervention groups at 6 months adjusting for baseline scores and transplant status. ITT was conducted and missing values were imputed using the LOCF.||Mean number of issues discussed||Standard Deviation|Mean
141502|NCT00457249|Other Pre-specified|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Either ADACEL® or DECAVAC® Vaccine.|Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (Temperature), Headache, Myalgia, and Malaise.|Day 0 up to 14 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.||Participants|||Number
141503|NCT00457249|Primary|Percentage of Participants With Booster Response to Tetanus and Diphtheria Post-vaccination With ADACEL® or DECAVAC® Vaccine.|Booster response was defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times, if pre-vaccination concentration is above the the cutoff value (Tetanus 5.47 IU/mL; Diphtheria 1.28 IU/mL) or at least 4 times it it is at or below the cutoff value.|Day 35 post-vaccination|Booster response was assessed in the per-protocol population.||Percentage of Participants|||Number
141504|NCT00457249|Primary|Percentage of Participants With Post-vaccination Tetanus and Diphtheria Concentrations ≥0.10 IU/mL (Seroprotection) ADACEL® or DECAVAC®.|Seroprotection was defined as a post-vaccination Concentrations of ≥0.10 IU/mL.|Day 35 post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of Participants|||Number
141505|NCT00457249|Primary|Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine||Day 35 post-vaccination|GMTs and their 95% Confidence Intervals were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
141506|NCT00457197|Secondary|Penn Alcohol Craving Scale (PACS)|"The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking~Score:~Minimum: 0 Maximum: 30 Lower score associated with better outcome."|12 weeks|Missing data for 1 participants in placebo group and 5 participants in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
141507|NCT00457197|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).~Score:~Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks|Missing data for 6 participants in placebo group and 1 participant in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
141508|NCT00457197|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.~Score:~Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks|Missing data for 4 participants in placebo group and 2 participants in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
141509|NCT00457197|Secondary|Hamilton Rating Scale for Depression (HRSD)|"The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).~Scale:~Minimum: 0 Maximum: 50 Lower score associated with better outcome"|12 weeks|Missing data for 2 participants in placebo group and 3 participants in the quetiapine group.||units on a scale||Standard Error|Least Squares Mean
141510|NCT00457197|Secondary|Alanine Aminotransferase (ALT)|ALT is a liver enzyme measurement (IU/I).|12 weeks|Missing data for 17 participants in placebo group and 13 participants in the quetiapine group.||IU/I||Standard Error|Least Squares Mean
141511|NCT00457197|Secondary|Aspartate Aminotransferase (AST)|AST is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 19 participants in placebo group and 11 participants in the quetiapine group.||IU/I||Standard Error|Least Squares Mean
141512|NCT00457197|Secondary|Gamma-glutamyltransferase (GGT)|GGT is a liver enzyme measurement (IU/I)|12 weeks|Missing data for 18 participants in placebo group and 11 participants in the quetiapine group.||IU/I||Standard Error|Least Squares Mean
141513|NCT00457197|Secondary|Percent of Heavy Drinking Days||12 weeks|||drinks||Standard Error|Least Squares Mean
141514|NCT00457197|Primary|The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.||12 weeks|||drinks||Standard Error|Least Squares Mean
141515|NCT00457015|Secondary|Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours|"Maintenance of significant improvement was defined as achieving and maintaining a significant improvement in overall response through 24 hours after dosing. Patient response categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse."|24 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.||participants|||Number
141516|NCT00457015|Secondary|Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score|A successful response was defined as improvement in existing laryngeal symptom complex,stabilization of an existing peripheral symptom complex, or a change from baseline in the MSCS score at 4 hours of at least -1.0.|baseline, 4 hours post-dosing|Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.||participants|||Number
141567|NCT00456807|Primary|Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines|The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||cells per million CD4/CD8 T-cells||95% Confidence Interval|Geometric Mean
141517|NCT00457015|Secondary|Patients With Significant Improvement in Overall Response|"Patients were to be asked to perform an overall response assessment at intervals during the first 4 hours post-dose. Assessments were to be made relative to baseline (ie, immediately before initial dosing) using a 5-category scale. Categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse. Significant improvement is the first time that a patient responded to the overall response assessment as a lot better or resolved."|4 hours post-dose|The time to significant improvement is not provided in this display as the estimated median times were not reached by 240 minutes. Instead, the number of patients with significant improvement is provided per treatment arm.||participants|||Number
141518|NCT00457015|Secondary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100; best value]to significant worsening [-100; worst value]). Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose|Patients were excluded from this analysis if they did not have data for the endpoint being analyzed. The reasons for patients being excluded from this analysis are for ecallantide: 1 patient treated for severe upper airway compromise and for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data.||units on a scale||Standard Deviation|Mean
141519|NCT00457015|Primary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose|Patients were excluded from the analysis if they did not have data for the endpoint being analyzed. Reasons for patients being excluded are for ecallantide: 1 patient treated for severe upper airway compromise; for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data. Best score=0.0; worst score=3.0.||units on a scale||Standard Deviation|Mean
141520|NCT00457002|Secondary|Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants|Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug and had available laboratory measurements.||participants|||Number
141521|NCT00457002|Secondary|Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements|Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.|Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)|Participants who received at least one dose of study drug, and had available laboratory results associated with the event and treatment group.||participants|||Number
141522|NCT00457002|Secondary|Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants|Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.|Day 1 to last dose of study drug plus 2 days|MI and thrombocytopenia categories: participants who received at least one dose of study drug. MI or stroke category: treated participants except those who did not have MI and had an inadequate assessment for stroke. Stroke category: treated participants except those with an inadequate assessment for stroke during the treatment period.||Event Rate (%)||95% Confidence Interval|Number
141523|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants|Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
141524|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants|Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
141568|NCT00456755|Secondary|Quality of Life (Difference Between Baseline and Week 4)|SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health).|4 week|ITT||Unit Score||Standard Deviation|Mean
141525|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants|Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
141526|NCT00457002|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants|Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a pre-therapy value, and had a value on the day specified were analyzed.||participants|||Number
141527|NCT00457002|Secondary|Mean Change From Baseline in Heart Rate in Treated Participants|Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.||bpm||Standard Deviation|Mean
141528|NCT00457002|Secondary|Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period|Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.||mmHg||Standard Deviation|Mean
141529|NCT00457002|Secondary|Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period|Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.|Day 1 to last dose of study drug plus 2 days|Participants who received at least one dose of study drug, had a baseline value, and had a value on the day specified were analyzed.||mmHg||Standard Deviation|Mean
141530|NCT00457002|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants|Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.|Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)|Participants who received at least one dose of study drug were analyzed (As Treated population).||participants|||Number
141531|NCT00457002|Secondary|Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period|A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
141532|NCT00457002|Primary|Incidence of All Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of drug to last dose of drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%)||95% Confidence Interval|Number
141571|NCT00456625|Secondary|Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~An AE is considered severe if it prevents normal, everyday activities."|During the 31-day follow-up period after the challenge dose of hepatitis B vaccine.|||participants|||Number
141533|NCT00457002|Primary|Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%)||95% Confidence Interval|Number
141534|NCT00457002|Primary|Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants|Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%):||95% Confidence Interval|Number
141535|NCT00457002|Primary|Incidence of Major Bleeding During the Treatment Period in Treated Participants|Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Day 1, first dose of study drug, to last dose of study drug plus 2 days|Participants who received at least one dose of study drug were analyzed (As Treated population). Participants were categorized to the group to which they were randomized, unless the same incorrect treatment was received throughout the study; in such case, the As Treated were equal to the treatment received.||Event Rate (%)||95% Confidence Interval|Number
141536|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment, were analyzed.||Event Rate (%)||95% Confidence Interval|Number
141537|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period|Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants, except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment period, were analyzed.||Event Rate (%)||95% Confidence Interval|Number
141538|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
141539|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
141540|NCT00457002|Secondary|Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
141541|NCT00457002|Secondary|Incidence of Adjudicated PE With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
141542|NCT00457002|Secondary|Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
141543|NCT00457002|Secondary|Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
141544|NCT00457002|Secondary|Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Randomized participants except those with an inadequate assessment for symptomatic events that are part of the endpoint during the intended treatment were analyzed.||Event Rate (%)||95% Confidence Interval|Number
141545|NCT00457002|Secondary|Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|All Randomized Participants.||Event Rate (%)||95% Confidence Interval|Number
141546|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
141547|NCT00457002|Secondary|Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period|Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
141569|NCT00456755|Primary|Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4|The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.|4 week|||Unit Score||Standard Deviation|Mean
141548|NCT00457002|Secondary|Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period|Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized with adjudicated and evaluable ultrasound at the end of the intended treatment period; for those with a suspected symptomatic event, the adjudication result was not inadequate; includes all those randomized who have an adjudicated event associated with the endpoint during Intended Treatment.||Event Rate (%)||95% Confidence Interval|Number
141549|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Secondary Efficacy Evaluable includes those who have an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event is not inadequate; or those with an adjudicated event that is part of the composite endpoint.||Event Rate (%)||95% Confidence Interval|Number
141550|NCT00457002|Secondary|Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants|Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).|Day 1 to last dose of parenteral study drug plus 1 day|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of parenteral treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had adjudicated and evaluable ultrasound at end of parenteral treatment, or had an adjudicated VTE-related death during the Parenteral Treatment Period.||Event rate (%)||95% Confidence Interval|Number
141551|NCT00457002|Primary|Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population|VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).|Intended Treatment Period|Those randomized (without suspected VTE) who had an adjudicated and evaluable ultrasound at end of intended treatment; or (with suspected VTE) had VTE events adjudicated as non-events and had an adjudicated and evaluable ultrasound at end of intended treatment, or had an adjudicated total VTE-related death.||Event rate (%)||95% Confidence Interval|Number
141552|NCT00456989|Secondary|Response Rate|Data not analyzed, PI left institution|7 years||||||
141553|NCT00456989|Primary|Maximum Tolerated Dose and Toxicity Profile|There is no data to report. Data for this trial was not analyzed, the PI left institution.|2 years||||||
141554|NCT00456846|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 to Day 940|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||participants|||Number
141555|NCT00456846|Secondary|Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Day 1 of study drug to Day 940; data cut off 31 May 2013|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||participants|||Number
141556|NCT00456846|Secondary|Patient Survival|Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive.|Study start until death, or until data cut-off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.||months||95% Confidence Interval|Median
141869|NCT00454142|Secondary|Pharmacokinetic Study: Volume of Distribution (Vd/F/Dose) on Day 1|Volume of distribution (Vd/F/dose) were measured on day 1 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 hrs after first dose.|Day 1 of treatment|||mL/mg||Full Range|Median
141557|NCT00456846|Secondary|Duration of Response Based on Investigator Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants that received at least one dose of study drug.||months||95% Confidence Interval|Median
141558|NCT00456846|Secondary|Duration of Response Based on Independent Reviewer Assessment|Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST).|Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months|Treated Population: The Treated population with a confirmed complete response or partial response.||months||95% Confidence Interval|Median
141559|NCT00456846|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||months||95% Confidence Interval|Median
141560|NCT00456846|Secondary|Percentage of Participants With Disease Control|Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
141561|NCT00456846|Primary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers|Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits|Every 8 weeks from study start until disease progression; Up to 61 months|Treated Population: The Treated population consisted of all enrolled participants who received at least one dose of study drug.||percentage of participants||95% Confidence Interval|Number
141562|NCT00456807|Primary|Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples|Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, only on those subjects from the Cervarix group with CVS sample results available.||correlation coefficient|||Number
141563|NCT00456807|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies|Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.|At Month 12 and Month 18 after first vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. None of the subjects in the Placebo Group had detectable antibodies against HPV-16 at Months 12 and 18 and against HPV-18 at Month 12.||Titer||95% Confidence Interval|Geometric Mean
141564|NCT00456807|Primary|Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies|Titers are presented as Geometric Mean Titers (GMTs).|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||Titer||95% Confidence Interval|Geometric Mean
141565|NCT00456807|Primary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 12 and Month 18 after first vaccination|Analysis was performed on subjects from the Total Vaccinated Cohort with available results.||Subjects|||Number
141870|NCT00454142|Secondary|Pharmacokinetic Study: Area Under Curve (AUC) 0-24h/Dose on Day 28|AUC 0-24h/dose were measured on day 28 for 26 evaluable participants. Blood sampling was done at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after day 28 dose.|Day 28 of treatment|||hr*ng/mL/mg||Full Range|Median
141572|NCT00456625|Primary|Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values|The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.|One month after the hepatitis B vaccine challenge dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (including all evaluable subjects who had received the challenge dose of hepatitis B vaccine and for whom immunogenicity data were available at the post-hepatitis B vaccine challenge dose timepoint).||participants|||Number
141573|NCT00456612|Primary|Progression Free Survival||consent to prgression or death||||||
141574|NCT00456612|Secondary|Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.||1year||||||
141575|NCT00456612|Primary|The Percent Progression -Free Survival at 6 Months Will be Tabulated||6 months||||||
141576|NCT00456599|Secondary|Overall Survival|Percent overall survival was calculated for all evaluable patients.|5 years|Of the 71 eligible patients, 68 were evaluable for overall response (1 patient was removed from study during cycle 1 for noncompliance, and 2 additional patients withdrew for reasons not related to toxicity or progression).||months||95% Confidence Interval|Median
141577|NCT00456599|Secondary|Time to Treatment Failure|Median time for disease recurrence after surgery.|2 years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.||months||Full Range|Median
141578|NCT00456599|Primary|Two-year Disease Free Survival.|The percent of patients alive and disease-free at two years.|two years|43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis.||percentage of patients||95% Confidence Interval|Number
141579|NCT00456261|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||months||95% Confidence Interval|Number
141580|NCT00456261|Secondary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months|||percentage of patients||95% Confidence Interval|Number
141581|NCT00456261|Primary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the date of treatment initiation and the date of progressive disease|18 months|||months||95% Confidence Interval|Median
141582|NCT00455975|Secondary|Overall Tolerability and Toxicity of High-dose Bevacizumab|Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities|18 months|All patients treated with Bevacizumab therapy were assessed for Grade 3/4 toxicities||participants|||Number
141583|NCT00455975|Secondary|Objective Response Rate|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|18 months|||participants|||Number
141584|NCT00455975|Secondary|Overall Survival (OS)|Measured from date of study entry to date of death due to any cause.|18 months|||months||95% Confidence Interval|Median
141585|NCT00455975|Primary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months (expected)|||months||95% Confidence Interval|Median
141586|NCT00455858|Secondary|Occurence of Hypoglycaemic Episodes|Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.|weeks 0-20|For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.||episodes|||Number
141587|NCT00455858|Secondary|Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%|Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%|week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||percentage of participants|||Number
141588|NCT00455858|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20|week 0, week 12, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||mg/dL||Standard Deviation|Mean
141589|NCT00455858|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12|Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline|week 0, week 12|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||percentage change in HbA1c||Standard Deviation|Mean
141590|NCT00455858|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20|Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20|week 0, week 20|The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.||percentage change in HbA1c||Standard Deviation|Mean
141623|NCT00455520|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Percentage of patients who reported very much improved (1) or much improved (2) based on an ordinal measure indicating change from start of double blind treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||percentage of patients|||Number
141591|NCT00455702|Secondary|Treatment Effects on the Positive Syndrome Subscale of the PANSS|The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8 score|One participant from the placebo group was removed from this analysis.||PANSS Positive Subscale Units||Standard Deviation|Mean
141592|NCT00455702|Primary|Main Outcome Measure: The Change From Baseline to Week 8 on the SANS|The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).|Baseline score vs. Week 8|||Units on a scale||Standard Deviation|Mean
141593|NCT00455663|Primary|Number of Patients Surviving Without Relapse/Exacerbation|A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision|9 months of treatment 6 months follow up|Number of participants meeting bprs criteria for at least partial remission.scores on 3 of the 4 BPRS psychosis items had to be 4 or lower indicating moderate symptoms only.||participants|||Number
141594|NCT00455663|Primary|Social and Occupational Functioning Scale Score|Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 endpoint ls means combining 9 months of treatment and 6 months follow up|||units on a scale||Standard Error|Mean
141595|NCT00455663|Primary|Positive Symptoms|Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up|||units on a scale||Standard Error|Least Squares Mean
141596|NCT00455663|Primary|Medication Adherence-pill Count|% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.|1 final score combined for endpoint for 9 months of treatment and 6 months follow up|||percentage of medication taken||Standard Error|Least Squares Mean
141597|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in 20- and 26-Gene Model Subgroups|For each of the 2 biomarker sets (20-gene or 26-gene), a multi-gene model was built using penalized logistic regression on all pharmacogenomic evaluable subjects for each treatment arm separately. Receiver Operating Characteristic (ROC) plots for separate arm using 5 fold cross validation were generated. ROC for separate arms using cross over were also added. Further analysis on the multiple gene models (as mentioned in the SAP) was planned only based on the initial findings from the 2 ROC plots. For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For 20- and 26-gene models, ROC curves generated for each study arm did not indicate that these multi-gene models differentially predicted for pCR between the treatment arms, so further analyses to estimate the optimal cut-off and the pCR rates were not conducted.|||||
141598|NCT00455533|Secondary|Number of Participants With Dose Delay and Reason for Dose Delay for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel||participants|||Number
141599|NCT00455533|Secondary|Number of Participants With Course Delay and Reason for Delay for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC||participants|||Number
141600|NCT00455533|Secondary|Reason for First Dose Reduction of Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of Ixabepilone/Paclitaxel||participants|||Number
141601|NCT00455533|Secondary|Reason for First Dose Reduction of AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants with at least 2 courses of AC||participants|||Number
141602|NCT00455533|Secondary|Number of Participants by Dose for Ixabepilone/Paclitaxel||12 weeks (4 3-week cycles for ixabepilone and 12 weekly doses for paclitaxel)|ixabepilone- and paclitaxel-treated participants||participants|||Number
141603|NCT00455533|Secondary|Number of Participants by Dose for AC||12 weeks (4 3-week cycles)|ixabepilone- and paclitaxel-treated participants||participants|||Number
141604|NCT00455533|Secondary|On-Study Renal Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.||Participants|||Number
141605|NCT00455533|Secondary|On-Study Liver Function: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST). AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded; n=number of participants with specific laboratory evaluation.||Participants|||Number
141606|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR) in Biomarker-Defined Populations|Beta III tubulin positivity determined by cross-validation method. Optimal cutoff: ≥46% tumor cells staining at 2 plus or 3 plus intensity (corresponding Beta III tubulin positivity=39.4%). Pre-specified cutoff of Beta III tubulin positivity: ≥50% 2plus or 3plus cells (corresponding prevalence=38.5%). Optimal cutoffs for TACC3 and CAPG positivity determined by cross-validation method: 6.889 and 6.844 [log2 normalized intensity units], respectively (corresponding to prevalence rates of 43.3% and 44.3%).|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|For all subgroups other than Beta-III positive/negative subgroup based on a pre-determined cutoff, results were estimated using a cross-validation method (a resampling based technique, making individual sample size [N] not applicable).||Percentage of Participants||90% Confidence Interval|Number
141607|NCT00455533|Secondary|On-Study Hematology: Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grade Per Participant in Ixabepilone/Paclitaxel Phase|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy during ixabepilone or paclitaxel treatment phase|Ixabepilone/Paclitaxel treated participants for whom on-study labs were recorded.||Participants|||Number
141608|NCT00455533|Secondary|Severity of Any Drug-Related AEs and Gastrointestinal AEs by System Organ Class|MCT=musculoskeletal and connective tissue, GDASC=general disorders and administration site conditions, RTM=respiratory, thoracic and mediastinal disorders, NBMUCP=neoplasms benign, malignant and unspecified (including cysts and polyps). Drug related adverse events are those events with relationship to study therapy of certain, probable, possible or missing. Subjects may have more than one event within a class. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy|Ixabepilone- and Paclitaxel-treated participants||Participants|||Number
141609|NCT00455533|Secondary|Overall Safety Summary: Deaths, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Drug-Related AEs, and Most Common Treatment-Related Non-Hematologic Adverse Events (TNAEs) Occuring in >=10% of Participants|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. By Worst Common Terminology Criteria of Adverse Events (CTCAE Version 3) Grades|prior to the first study treatment, at the beginning of each subsequent cycle, weekly during the treatment period and a minimum of 4 weeks after the last dose of 12 weeks of study therapy|||Participants|||Number
141610|NCT00455533|Secondary|Prevalence of Biomarker Based on Optimal Threshold (Biomarker Positive Participants)|Percentage of participants having the following optimal biomarker thresholds as computed from the cross-validation method (cutoff of biomarker positive [with 90% confidence interval by Bootstrap method]): Beta 3 Tubulin IHC (45.866 [5, 83.9]); TACC3 mRNA (6.714 [6.312, 7.192]); CAPG mRNA (6.739 [5.728, 7.298]). Optimal thresholds for a 20-gene model and a 26-gene model were also planned; however, these were not determined because preliminary analyses did not indicate that they would not differentiate pCR rates between treatment arm.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy and mRNA samples obtained prior to treatment|Randomized participants with non-missing pCR and biomarker expressions. n=the number of participants with specific biomarker expression.||Percentage of Participants||90% Confidence Interval|Number
141611|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds, Estrogen-Receptor (ER) Negative Participants|Percentage of ER negative participants with pCR and MDR1 immunohistochemistry (IHC) positivity using 2 pre-specified thresholds, stratified by biomarker status. The first pre-specified threshold for MDR1-positivity (Mem)=Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized estrogen negative participants with non-missing pCR and biomarker expression||percentage of participants||90% Confidence Interval|Number
141612|NCT00455533|Secondary|Percentage of Participants With pCR/RCB1 and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-specified Thresholds|Percentage of participants with pCR/RCB1 in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score .|pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR/RCB1 and biomarker expression||percentage of participants||90% Confidence Interval|Number
152427|NCT00365846|Secondary|Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)||3 years|||participants|||Number
141613|NCT00455533|Secondary|Percentage of Participants With pCR and MDR1 Immunohistochemistry (IHC) Positivity Using Two Pre-Specified Thresholds|Percentage of participants with pCR in MDR1 IHC positive and negative groups using 2 pre-specified thresholds,. The first pre-specified threshold for MDR1-positivity (Mem) =Any membrane staining. The second pre-specified threshold for MDR1-positivity (Mem+Cyto)=Any membrane staining or at least 200 Cytoplasmic H-score.|: pCR evaluated at time of surgery (4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|Randomized participants with non-missing pCR and biomarker expression||percentage of participants||90% Confidence Interval|Number
141614|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]) to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR/RCB1|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR/RCB1 as response. Statistical analyses include: 1) likelihood ratio test between the full model (pCR/RCB1~Biomarker:Treatment: ER) & reduced model (pCR/RCB1~Treatment:ER); 2) likelihood ratio test between the full model (pCR/RCB1 Biomarker:Treatment) & reduced model (pCR/RCB1~Biomarker+Treatment); 3) contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model (pCR/RCB1~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (4-6 weeks after the last dose of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|||participants|||Number
141615|NCT00455533|Secondary|Randomized Participants With Non-missing pCR & Biomarker Expression (GENE [Probe Set]), to Explore Whether Gene Expression Patterns for GTSE1, Isoforms of β-tubulin, Kallikreins 5, 6, 10 Are Differentially Predictive of pCR|Relevance of biomarker in differentiation between ixabepilone & paclitaxel evaluated by logistic regression with pCR as response. Statistical analyses include: 1) the likelihood ratio test between the full model (PCR~Biomarker:Treatment:estrogen receptor [ER]) & reduced model (PCR~Treatment:ER); 2) the likelihood ratio test between the full model (PCR~Biomarker:Treatment) & reduced model (PCR~Biomarker+Treatment); 3) the contrast of the interaction between treatment & biomarker expression within ER Negative subjects from the full model(PCR~Biomarker:Treatment:ER). A:B represents A,B & A*B.|pCR evaluated at time of surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy); mandatory tumor tissue biopsy obtained prior to treatment.|||participants|||Number
141616|NCT00455533|Secondary|Percentage of Participants Achieving Combined pCR and Minimal Residual Cancer Burden (RCB) 1|Combined pCR and RCB-1 was defined as participants with no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of DCIS in the breast plus subjects with RCB-1 following the RCB calculation based on data entered by the investigator sites in each arm.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
141617|NCT00455533|Secondary|Percentage of Participants Requiring Breast Conservation Surgery|Number of randomized participants requiring breast conservation surgery following study treatment.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
141618|NCT00455533|Secondary|Percentage of Participants Achieving Clinical Objective Response|Clinical response was defined as the number of participants who achieved modified World Health Organization’s tumor response criteria of clinical complete response (complete disappearance of all clinically palpable detectable malignant disease and/or disappearance of radiological evidence of tumor in the breast and ipsilateral axillary lymph nodes) or clinical partial response (clinical evidence of a reduction in total tumor size of >= 50% in the overall sum of the products of diameters of breast and axillary lesions), divided by the number of randomized participants in that arm.|after the last dose of either ixabepilone or paclitaxel (at 12 weeks) but before surgery (4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
141619|NCT00455533|Primary|Percentage of Participants Achieving Pathologic Complete Response (pCR)|The pCR was defined as no histologic evidence of residual invasive adenocarcinoma in the breast and axillary lymph nodes, with or without the presence of ductal carcinoma in situ (DCIS) in the breast.|at surgery (performed 4-6 weeks after the last dose of 12 weeks of therapy)|All randomized participants||Percentage of Participants||90% Confidence Interval|Number
141620|NCT00455520|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||Scores on a scale||Standard Deviation|Mean
141621|NCT00455520|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time (hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||Hours||Standard Deviation|Mean
141622|NCT00455520|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|12 week endpoint (change from baseline)|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||scores on a scale||Standard Deviation|Mean
141871|NCT00454142|Secondary|Pharmacokinetic Study: AUC0-24h/Dose on Day 1|AUC 0-24h/dose were measured on day 1 for 26 evaluable participants. Blood sampling is done at zero (pre-dose), 0.5 hr, 1, 2, 3, 4, 5, 6 and 8 hrs after the first dose.|Day 1 of treatment|||hr*ng/mL/mg||Full Range|Median
152428|NCT00365846|Primary|Incidence of Allograft Rejection||3 years|||participants|||Number
141624|NCT00455520|Secondary|The Number of Patients Achieving at Least 30% Improvement in Pain Score at Week 12 of the Double-blind Maintenance Period From the Start of the Open Label Period.|The number of patients achieving at least 30% improvement in pain score at Week 12 of the double-blind maintenance period on an 11-point numerical rating scale compared with the start of the open-label period.|Start of Open Label and at 12 weeks of Double Blind|Intent-to-treat analysis set.||participants|||Number
141625|NCT00455520|Primary|Change From Baseline (at Randomization) in Average Pain Intensity on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Double-blind Maintenance Period at Week 12|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent to Treat (ITT) analysis set included all randomized subjects who took at least one dose of study medication during the double blind maintenance period with the exception of 3 subjects who were enrolled in the study twice.||scores on a scale||Standard Deviation|Mean
141626|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
141627|NCT00455455|Primary|Conjunctival Sensitivity|The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
141628|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|day 7|intent to treat analysis including only participants who had completed the study||units on a scale||Standard Deviation|Mean
141629|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|day 7|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
141630|NCT00455455|Secondary|Corneal Staining Grade|A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).|baseline|intent to treat analysis including only participants who had completed the study||units on a scale||Standard Deviation|Mean
141631|NCT00455455|Primary|Corneal Sensitivity|The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.|baseline|intent to treat analysis including only participants who had completed the study||percent CO2||Standard Deviation|Mean
141632|NCT00455429|Secondary|Plasma Concentration of JNJ-26113100|Blood samples for pharmacokinetic (PK) analysis were collected before dosing and at 0.25 to 3 hours after dosing at randomization (Day 1) and Week 3 visit and at 0.25 to 3 hours, 4 to 6 hours, and 7 to 12 hours after dosing at Week 6.|Before dosing on Day 1, Week 3, Week 6; after dosing at 0.25 to 3 hours on Day 1, Week 3, Week 6; after dosing at 4 to 6 hours and 7 to 12 hours on Week 6|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to treatment groups and received at least 1 dose of study drug. LOCF method was used.||nanogram (ng)/milli litre (mL)||Standard Deviation|Mean
141633|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Worsening AD Event|Percentage of Participants who had at least 1 Worsening AD Event That did not Meet Flare Criteria were assessed. Worsening of AD that did not meet flare criteria was documented. Flare was considered to be present if either of the following criteria were met: 1) IGA was=2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141634|NCT00455429|Primary|Number of Flare Occurrences Per Participant|A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0 or 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||participants|||Number
141635|NCT00455429|Primary|Percentage of Participants Who Had at Least 1 Flare|Percentage of participants who had at Least 1 Flare while on treatment was assessed. A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141636|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141654|NCT00455013|Secondary|Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion|Long Term extension was the period from the end of Month 12 to the end of Month 48 post transplantation and the completion of the study 31 July 2012. At any time in the study, participants who were unable to tolerate MMF in the Bela-MMF and Tac-MMF groups could discontinue (DC) MMF and switch to sirolimus and remain in the study and those in the Bela-Siro group who were unable to tolerate sirolimus could DC sirolimus and switch to MMF and remain in the study. Study completion=data base (DB) lock.|End of Month 12 to end of Study (Month 48)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form||participants|||Number
141637|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141638|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst Possible Itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141639|NCT00455429|Primary|Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=25% from the baseline EASI score. An improvement of <25% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141640|NCT00455429|Primary|Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of >=50% from the baseline EASI score. An improvement of <50% is considered a failure.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141641|NCT00455429|Primary|Percentage of Participants Achieving Treatment Response as “Clear” or “Almost Clear “in IGA|Percentage of participants achieving treatment response (decrease) in IGA were assessed. IGA is used to assess AD through a 6-point scale (Range=0-5) where, 0=clear (no inflammatory signs of AD), 1=almost clear (just perceptible erythema & perceptible papulation/infiltration), 2=mild (mild erythema & papulation/infiltration), 3=moderate (moderate erythema & papulation/infiltration), 4=severe (severe erythema & papulation/infiltration) & 5=very severe (severe erythema & papulation/infiltration with oozing/crusting). Success is reduction of IGA to 0 or 1. Failure is reduction of IGA to >=2.|Baseline up to Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||percentage of participants|||Number
141642|NCT00455429|Primary|Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6|VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm=“No itch” on the left side of the line and the words 10 cm=“Worst possible itch” on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between “No itch” and “Worst possible itch” which best describes their itching during the preceding 24 hours.|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||millimeter (mm)||Standard Deviation|Mean
141643|NCT00455429|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6|EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.||units on a scale||Standard Deviation|Mean
141644|NCT00455429|Primary|Investigator's Global Assessment (IGA) Score at Week 6|Participants were reported for IGA. IGA is an overall assessment of Atopic Dermatitis (AD). IGA utilizes a 6-point scale (ranging from 0 to 5): 0=clear (noinflammatory signs of AD), 1=almost clear (just perceptible erythema, and just perceptible papulation/infiltration), 2=mild disease (mild erythema, and mild papulation/infiltration), 3=moderate disease (moderate erythema, and moderate papulation/infiltration), 4=severe disease (severe erythema, and severe papulation/infiltration) and 5=very severe disease (severe erythema, and severe papulation/infiltration with oozing/crusting).|Week 6|Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. Last Observation Carried Forward (LOCF) method was used.||participants|||Number
152429|NCT00365768|Secondary|Number of Participants With Progression of Neuropathy||42 days|||participants|||Number
141645|NCT00455195|Secondary|Change From Baseline in Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and is standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Change is calculated as the value minus the baseline value. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0 , Week 104|Intent-to-treat population of participants who had valid baseline (Week 0) and Week 104 data.||units on a scale||Standard Deviation|Mean
141646|NCT00455195|Secondary|Baseline Values (Week 0) for Quality of Life Related to Physical Component Score (PCS) as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Score reports the four domains of physical functioning, role-physical, bodily pain, and general health and are standardized as Z-scores (scale of 0-100). Higher scores are associated with better quality of life. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population of participants with valid baseline (Week 0) PCS surveys.||units on a scale||Standard Deviation|Mean
141647|NCT00455195|Primary|Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.||percent of predicted FVC||Standard Deviation|Mean
141648|NCT00455195|Primary|Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population||percent of predicted FVC||Standard Deviation|Mean
141649|NCT00455195|Secondary|Change From Baseline (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.||percent of predicted QMT||Standard Deviation|Mean
141650|NCT00455195|Primary|Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600). Change is calculated as the value minus the baseline value.|Week 0, Week 104|Intent-to-treat population of participants who had both baseline (Week 0) and Week 104 data.||meters||Standard Deviation|Mean
141651|NCT00455195|Primary|Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Six-Minute Walk Test (6MWT) measures the distance walked (in meters) in 6 minutes. A longer distance indicates greater endurance. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600).|Week 0|Intent-to-treat population.||meters||Standard Deviation|Mean
141652|NCT00455195|Secondary|Baseline Values (Week 0) for Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and are an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|Week 0|Intent-to-treat population||percent of predicted QMT||Standard Deviation|Mean
141653|NCT00455195|Primary|Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600)|"The numbers of participants who experienced Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment with alglucosidase alfa.~Participants with long-term exposure to alglucosidase alfa (those from the Alglucosidase Alfa/Alglucosidase Alfa treatment group) are included. Time frames are stated from the start of the double-blind study AGLU02704 (NCT00158600)."|Week 0 to 2.5 years|The safety population includes all participants randomized to alglucosidase alfa treatment in AGLU02704 (NCT00158600) who received at least one infusion of alglucosidase alfa.||participants|||Number
141655|NCT00455013|Secondary|Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Participants were considered corticosteroid-free at Months 24, 36, and 48 if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants were considered CNI-free at Months 24, 36, and 48 if they were not receiving CNI during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor.|Months 24, 36, 48|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.||participants|||Number
141656|NCT00455013|Secondary|Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|In the LTE, a participant was considered corticosteroid-free if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively.|End of Month 12 to end of Long Term Extension (Year 4)|N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.||participants|||Number
141657|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension|GFR was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Age in years, Alb = Albumin in g/dL; SCr = in mg/dL; BUN =Blood urea nitrogen in mg/dL. Intent to Treat population is defined as all participants randomized and transplanted.|Months 24, 36 and 48 post transplantation|N=All participants who were randomized, transplanted, in the LTE and had data available at the specific time point.||mL/Min/1.73m^2||Standard Deviation|Mean
141658|NCT00455013|Secondary|Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|End of Month 12 to end of Long Term Extension (Year 4)|N=participants randomized and transplanted and in LTE.||participants|||Number
141659|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|End of Month 12 to end of Month 48 Post Transplantation|All participants who completed the short term (ST) period, were eligible and accepted to enter the LTE by signing a new informed consent form.||participants|||Number
141660|NCT00455013|Secondary|Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population|Participants were said to be CNI-free at Month 6 or 12 if they were not receiving a CNI during Day 141 to Day 196, or Day 337 to Day 392. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. Participants were corticosteroid-free (CS-free) at Month 6 if they were not receiving corticosteroids for > 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Day 1 was day of transplantation. Intent to treat population included all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|Analysis on both CNI-free and CS-free participants based on all followed up at least 151 days for Month 6 or 347 days for Month 12. One participant in the tacrolimus arm was counted as CNI-free since he discontinued tacrolimus on Day 2 of transplant and no data were available regarding immunosuppressive therapy after discontinuation.||participants|||Number
141661|NCT00455013|Secondary|Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population|Participants were said to be corticosteroid-free at Month 6 if they were not receiving corticosteroids for greater than (>) 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Intent to treat population included all randomized and transplanted participants.|Day 1 through Month 12|For 95% CI within each group, normal approximation was used if N greater than, equal to (>=)5. Otherwise, exact method was used. Numbers of participants analyzed at Month 6 in each arm were 33, 26, 30 and numbers of participants analyzed at Month 12 were 32, 26, 30, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.||participants|||Number
141662|NCT00455013|Secondary|Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Blood urea nitrogen (BUN) in mg/dL; Albumin (Alb) in g/dL;Serum creatinine (SCr) in mg/dL; Age in years. Glomerular filtration rate (GFR) was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Intent to Treat (ITT) population is defined as all participants randomized and transplanted.|Months 3, 6 and 12 post transplantation|Month 12 n presented above. Calculated GFR, values >180 mL/min/1.73 m2 (beyond upper limit of biologic plausibility)were truncated at 180 mL/min/1.73 m^2. Based on median (SD) GFR of 83 (50).||mL/min/1.73m^2||Standard Deviation|Mean
141663|NCT00455013|Secondary|Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population|Baseline (BL) was value obtained day prior to transplantation. Lipid values measured in milligrams/deciliter (mg/dL) included: high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), non-HDL cholesterol (non-HDL-C), total cholesterol (TC), triglycerides. Intent to treat population included all participants randomized and transplanted.|Baseline to Month 12|33, 26, 30 participants were included in the ITT population. Number of participants analyzed for HDL-C = 26, 22, 26; non-HDL-C = 26, 22, 26; LDL-C = 20, 14, 21; TC = 26, 22, 26; triglycerides = 20, 14, 21, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.||mg/dL||Standard Deviation|Mean
141664|NCT00455013|Secondary|Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population|Participants using > = 1 antihyperlipidemic medication at Month 12.|Month 12|Analysis based on all participants who were followed up at least 364 days.||participants|||Number
141665|NCT00455013|Secondary|Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population|Systolic, diastolic and mean arterial blood pressures were measured in millimeters of mercury (mm Hg). Baseline was defined as value obtained before transplantation. Intent to treat population included all participants randomized and transplanted.|Baseline and 12 months post transplantation|Number analyzed at baseline presented above. Number analyzed at Month 12: 28, 22, 29 in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF treatment arms,respectively. Measurements obtained immediately after drug infusion were excluded from analysis.||mm Hg||Standard Deviation|Mean
141666|NCT00455013|Secondary|Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population|Baseline was defined as day prior to transplantation. Number of anti-hypertension medications taken were categorized from 1 to 6 and greater than (>)6. Intent to treat population included all participants randomized and transplanted.|Baseline and Month 12|ITT population, 33, 26, 30 for each arm, respectively, was used for each time point (baseline and Month 12). At baseline, 2 participants in each arm were not using at least one medication. 8, 6, and 10 participants in each arm respectively, were not using at least one medication at Month 12.||participants|||Number
141667|NCT00455013|Secondary|Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population|"Baseline defined as day before transplantation. A participant who did not have diabetes prior to randomization and received an antidiabetic medication for a duration of at least 30 days or a participant who meets the following criteria and did not have diabetes prior to randomization: Symptoms of diabetes plus casual plasma glucose (PG) concentration ≥ 200 mg/dL (11.1 mmol/L); or fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L); or 2-hour PG ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test and a confirmatory laboratory test based on measurements of venous PG must have been done on another day in the absence of unequivocal hyperglycemia accompanied by acute metabolic decompensation.~Intent to treat population included all participants randomized and transplanted."|Baseline to Month 12|||participants|||Number
141668|NCT00455013|Secondary|Number of Participants With Delayed Graft Function - Intent to Treat Population|Delayed graft function (DGF) is defined as participant requiring dialysis within the first week (Day 1-8) post transplantation. Participants losing their graft less than 48 hours post transplant and receiving chronic dialysis were not considered as having DGF. Day 1 was day of transplantation. Intent to treat population defined as all participants randomized and transplanted|From Day 1 up to and including Day 8 post transplantation|||participants|||Number
141669|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population|Subjects with graft loss or death prior to Month 12 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 12|||participants|||Number
141670|NCT00455013|Secondary|Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population|Participants with graft loss or death prior to Month 6 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.|Day 1 up to Month 6|Intent to treat population included all randomized and transplanted participants.||participants|||Number
141671|NCT00455013|Secondary|Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.|Day 1 to Month 6 and Month 12 post transplantation|Participants surviving with a functioning graft were 30, 24, 30 in belatacept/MMF, belatacept/sirolimus, tacrolimus/MMF arms, respectively. Participant who died had functioning graft at time of death.||participants|||Number
141672|NCT00455013|Secondary|Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population|AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.|Day 1 to Month 12 post transplantation|For 95% CI within each group, normal approximation was used if N greater than, equal to 5. Otherwise, exact method was used.||participants|||Number
141682|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||µg/mL||95% Confidence Interval|Geometric Mean
141673|NCT00455013|Primary|Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population|AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with >25% of parenchyma affected and moderate tubulitis with >4 mononuclear cells/tubular cross section; IB: >10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells.|Day 1 to Month 6 post-transplantation|Participants with more than one episode of AR were counted once only and the episode with the worst grade was used. For 95% Confidence Interval (CI) within each group, normal approximation was used if N greater than, or equal to (>=) 5. Otherwise, exact method was used. ITT population defined as all randomized and transplanted participants.||participants|||Number
141674|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Within (31-Days) at Year 2|The Total Cohort Year 2 included all vaccinated subjects in the booster study 104056 who came back for the Year 2 follow-up and also all subjects of NoBoost Group who were enrolled and vaccinated at Visit 2 (i.e. 40-43 months of age).||Subjects|||Number
141675|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 48 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)||Subjects|||Number
141676|NCT00454987|Primary|Number of Subjects With SAE(s)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 24 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)||Subjects|||Number
141677|NCT00454987|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|Up to Month 12 (Booster vaccination)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study Hib-MenC-TT- 013 BST:012 (104056)||Subjects|||Number
141678|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||EL.U/mL||95% Confidence Interval|Geometric Mean
141679|NCT00454987|Primary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
141680|NCT00454987|Primary|Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies|Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects||95% Confidence Interval|Number
141681|NCT00454987|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)|The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
142042|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
141683|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
141684|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
141685|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
141686|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjetcs|||Number
141687|NCT00454987|Primary|Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
141688|NCT00454987|Primary|Concentration of Anti-PSC Antibodies|Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||µg/mL||95% Confidence Interval|Geometric Mean
141689|NCT00454987|Primary|Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)|The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
141690|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||µg/mL||95% Confidence Interval|Geometric Mean
141691|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
141692|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
141693|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||µg/mL||95% Confidence Interval|Geometric Mean
141694|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
141893|NCT00453349|Secondary|Number of Subjects Who Received Alternative Medicine|As alternative medicine any systemic antibacterial medication was considered.|Up to 42 days after end of treatment|The number of subjects who received alternative medicine in the PP population was analyzed. The clinical response was graded as alternative medicine (clinical cure, improvement, continued clinical cure) versus no alternative medicine.||participants|||Number
141695|NCT00454987|Primary|Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
141696|NCT00454987|Primary|Concentration of Anti-PRP Antibodies|Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||µg/mL||95% Confidence Interval|Geometric Mean
141697|NCT00454987|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)|The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
141698|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Titre||95% Confidence Interval|Geometric Mean
141699|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
141700|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 4|The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had assay results available for at least one tested antigen at Year 4.||Subjects|||Number
141701|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Titre||95% Confidence Interval|Geometric Mean
141702|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Titre||95% Confidence Interval|Geometric Mean
141703|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
141704|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
141705|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
141706|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 2|The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056 or a 3-dose a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.||Subjects|||Number
141720|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.|The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141707|NCT00454987|Primary|rSBA-MenC Antibody Titers|Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Titre||95% Confidence Interval|Geometric Mean
141708|NCT00454987|Primary|Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
141709|NCT00454987|Primary|Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8|The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.|At Year 1|The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in studies 103974 and 104056, who had available assay results for at least one tested antigen at Year 1.||Subjects|||Number
141710|NCT00454857|Secondary|Number of Participants Requiring Splenectomy|The number of participants who required a splenectomy during the 12-month prospective phase of the study.|12 months|All enrolled participants who completed at least 1 observational study visit during the prospective phase.||Participants|||Number
141711|NCT00454857|Secondary|Duration of Exposure to ITP Medication|Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase. N=number of participants using each medication.||Months||Standard Deviation|Mean
141712|NCT00454857|Secondary|Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase|The number of participants who received drug therapies for the treatment of ITP during the prospective phase of the study. Use of multiple medications by the same participants is possible.|12 months (prospective data collection phase)|All enrolled participants who completed at least 1 observational study visit during the prospective phase.||Participants|||Number
141713|NCT00454857|Secondary|Change From Baseline to Month 12 in Treatment Satisfaction|Participant satisfaction with treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), an 11-item questionnaire providing scores on four scales – side effects, effectiveness, convenience and global satisfaction. TSQM Scale scores range from 0 to 100 with higher scores indicating more satisfaction with treatment.|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.||Units on a scale||Standard Deviation|Mean
141714|NCT00454857|Secondary|Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0).|Baseline to Month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all subjects who completed at least one questionnaire during the prospective observation period.||Units on a scale||Standard Deviation|Mean
141715|NCT00454857|Secondary|Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)|The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. Scores for each scale range from 0 (worst) to 100 (best).|Baseline to month 12 during prospective data collection phase|The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.||Units on a scale||Standard Deviation|Mean
141716|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.|The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141717|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.|The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141718|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.|Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141719|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment|The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141743|NCT00454805|Secondary|Duration of Response|Number of days from date of response (complete/partial based on RECIST) to date of progression|Every 8 weeks until progression or discontinuation|||Days||Full Range|Median
141721|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Third-line Treatment.|The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141722|NCT00454857|Primary|The Number of Participants Utilizing ITP Therapies for Second-line Treatment.|The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141723|NCT00454857|Primary|Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment|The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.|Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).|All enrolled participants||Participants|||Number
141724|NCT00454818|Other Pre-specified|Phase 1 and Phase 2: All Subject Deaths Through 36 Months|"All subject deaths that occurred during the 12-month study or the 24-month follow-up in subjects enrolled in either the Phase 1 or Phase 2 trial. Events occurring after early termination from the trial are listed as occurring during long-term follow-up, but may have been within 12 months. Specifically, two cardiovascular (CV) deaths in placebo subjects occurred following early study termination, but within 12 months of study initiation. These deaths are therefore included under Deaths within 12 months but also listed as Cardiovascular deaths in long-term follow-up. Accordingly, the number of Cardiovascular deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 of the deaths occurred within 12 months but after early termination."|36 months|"Includes all participants enrolled in the Phase 1 or Phase 2 trial. Events occurring after early termination are listed under long-term follow-up. The number of CV deaths in long-term follow-up for the placebo group is greater than the number of Deaths after 12 months, as 2 deaths occurred within 12 months but after early termination."||participants|||Number
141725|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) From Baseline to Month 12|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||mL||Standard Deviation|Mean
141726|NCT00454818|Primary|Phase 2: Change in Absolute Left Ventricular End Systolic Volume (LVESV) Frm Baseline to Month 6|Contrast echocardiography was used to determine LVESV. Decreases in LVESV are associated with reduced mortality. Changes from baseline with positive values indicate a worsening in heart function and changes from baseline with negative values indicate an improvement in symptoms.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||mL||Standard Deviation|Mean
141727|NCT00454818|Primary|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 6|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||Percentage of blood ejected from the LV||Standard Deviation|Mean
141728|NCT00454818|Other Pre-specified|Phase 2: Change in Percentage of Blood Ejected From the Left Ventricle (LV) (i.e., Left Ventricular Ejection Fraction [LVEF]) From Baseline to Month 12|Contrast echocardiography was used to determine LVEF. Increases in LVEF are associated with reduced mortality. Changes from baseline with positive values indicate an improvement in heart function and changes from baseline with negative values indicate a worsening of heart function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||Percentage of blood ejected from the LV||Standard Deviation|Mean
141729|NCT00454818|Post-Hoc|Phase 2: Selected Clinical Outcomes During 12-month Study Period|Incidences of key clinical endpoints as adjudicated by the blinded Clinical Endpoint Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||percentage of participants|||Number
141730|NCT00454818|Other Pre-specified|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 12|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.||pg/mL||Standard Deviation|Mean
141731|NCT00454818|Other Pre-specified|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 12|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. Peak VO2 data were not available for one patient in the placebo group.||mL/kg per minute||Standard Deviation|Mean
141982|NCT00453102|Secondary|Overall Survival (OS) Rate|The time from the date of initiation of study treatment until date of death from any cause for all participants.|End of Study|Median overall survival by Kaplan-Meier method for all patients was not attained.||months|||Number
141732|NCT00454818|Other Pre-specified|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 12|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||meters||Standard Deviation|Mean
141733|NCT00454818|Other Pre-specified|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 12: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).~The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.~For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 12 months|This analysis was performed on the intention to treat population, which included all patients randomized to treatment.||units on a scale||Standard Deviation|Mean
141734|NCT00454818|Other Pre-specified|Phase 2: Length of Cardiovascular-related Hospitalizations at 12 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||days||Standard Deviation|Mean
141735|NCT00454818|Primary|Phase 2: Change in Absolute Levels of N-terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) From Baseline to Month 6|NT-proBNP is a biomarker for heart failure. Increased levels of this biomarker are associated with increased mortality and cardiovascular hospitalization in patients with heart failure.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial. NT-proBNP data were not available for 1 patient in the MYDICAR high dose group.||pg/mL||Standard Deviation|Mean
141736|NCT00454818|Primary|Phase 2: Change in Peak Maximum Oxygen Consumption (VO2) From Baseline to Month 6|Peak VO2 is a measure of maximal oxygen consumption during cardiopulmonary exercise testing; this study used the modified Naughton treadmill protocol. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||mL/kg per minute||Standard Deviation|Mean
141737|NCT00454818|Primary|Phase 2: Change in 6-minute Walk Test (6MWT) From Baseline to Month 6|The 6MWT measures the distance walked in meters during a 6-minute test. Higher values indicate a better functional status. Changes from baseline with negative values indicate a worsening in function and changes from baseline with positive values indicate an improvement in function.|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||meters||Standard Deviation|Mean
141738|NCT00454818|Primary|Phase 2: Change in Symptomatic Efficacy Domains From Baseline to Month 6: New York Heart Association (NYHA) Class and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) Score|"NYHA classification is a symptomatic assessment in which the investigator evaluates subjects on a scale ranging from Class I (subjects with no limitation of activities, no symptoms from ordinary activities) to Class IV (subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).~The MLWHFQ is a patient-reported quality of life (QoL) measure in which patients assess the impact of their heart condition on activities in the past month using a Likert scale ranging from 0 (no effect) to 5 (very much effect). Higher scores thus indicate a lower QoL. The maximum (worst) score is 105 and the minimum (best) score is 0.~For both measures, changes from baseline with positive values indicate a worsening in symptoms and changes from baseline with negative values indicate an improvement in symptoms."|Baseline to 6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||units on a scale||Standard Deviation|Mean
141739|NCT00454818|Primary|Phase 2: Length of Cardiovascular-related Hospitalizations at 6 Months|Mean number of days in the hospital for cardiovascular-related complications. All hospitalizations were evaluated and classified by the blinded Clinical Endpoints Committee.|6 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||days||Standard Deviation|Mean
141740|NCT00454818|Primary|Phase 2: Incidence of Treatment-emergent Adverse Events (TEAE) at 12 Months|"Includes all adverse events that occurred from the time of first infusion of the investigational product or placebo to the 12-month visit. The category of TEAEs related to the investigational product (IP) includes TEAEs considered by the investigator to be possibly, probably, or definitely related to the IP."|12 months|This analysis was performed on the intention to treat population of the Phase 2 period, which included all patients randomized to treatment in the Phase 2 trial.||percentage of participants|||Number
141741|NCT00454805|Secondary|Duration of Clinical Benefit|Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months.|Every 8 weeks until progression or discontinuation|||Days||Standard Deviation|Mean
141742|NCT00454805|Secondary|Clinical Benefit Rate|"Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months.~The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off."|Every 8 weeks until progression or discontinuation|||Ratio|||Number
141744|NCT00454805|Secondary|Objective Response Rate|"Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as:~Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.~Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase.~Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.|||Participants|||Number
141745|NCT00454805|Primary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.|||Days||95% Confidence Interval|Median
141746|NCT00454779|Secondary|Overall Survival (OS) for the Second-line Treatment|Time from the first dose of panitumumab monotherapy to the date of death during the entire study|Until death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Months||95% Confidence Interval|Median
141747|NCT00454779|Secondary|Time to Response (TTR) During the Second-line Treatment Phase|Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Weeks||Standard Deviation|Mean
141748|NCT00454779|Secondary|Duration of Response (DOR) During the Second-line Treatment Phase|Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Months||95% Confidence Interval|Median
141749|NCT00454779|Secondary|Rate of Disease Control (RDC) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Percentage of Participants||95% Confidence Interval|Mean
141750|NCT00454779|Secondary|Overall Response Rate (ORR) During the Second-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Percentage of Participants||95% Confidence Interval|Mean
141751|NCT00454779|Secondary|Progression Free Survival (PFS) During the Second-line Treatment Phase|The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.|Every 6 weeks until disease progression or death, up to 57 months|Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy||Months||95% Confidence Interval|Median
141752|NCT00454779|Secondary|Overall Survival (OS) for the First-line Treatment|Time from the date of randomization to the date of death during the entire study|Until death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)||Months||95% Confidence Interval|Median
141753|NCT00454779|Secondary|Time to Response (TTR) During the First-line Treatment Phase|Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Weeks||Standard Deviation|Mean
141791|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
141754|NCT00454779|Secondary|Duration of Response (DOR) During the First-line Treatment Phase|Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review and objective response||Months||95% Confidence Interval|Median
141755|NCT00454779|Secondary|Rate of Disease Control (RDC) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review||Percentage of Participants||95% Confidence Interval|Mean
141756|NCT00454779|Secondary|Overall Response Rate (ORR) During the First-line Treatment Phase|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.|Every 6 weeks until disease progression or death, up to 67 months|all randomized subjects < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators’ review||Percentage of Participants||95% Confidence Interval|Mean
141757|NCT00454779|Primary|Progression Free Survival (PFS) During the First-line Treatment Phase|The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.|Every 6 weeks until disease progression or death, up to 67 months|All randomized participants < 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab)||Months||95% Confidence Interval|Median
141758|NCT00454649|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline and thereafter every 2 cycles up to disease progression or discontinuation from study or up to 155 weeks|Population included all participants who received at least 1 dose of study medication and had at least 1 target lesion according to RECIST and a baseline assessment of disease.||Percentage of Participants|||Number
141759|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Pemetrexed|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141760|NCT00454649|Secondary|Plasma Clearance (CL) for Pemetrexed|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
141761|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
141762|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pemetrexed||0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
141763|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Pemetrexed|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 10 minutes (end of infusion), 0.5, 1, 1.5, 2, 4, 6, 8 hr after end of infusion on Day 1 of Cycle 2 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
141764|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Cisplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141765|NCT00454649|Secondary|Plasma Clearance (CL) for Cisplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
141766|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
141767|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Cisplatin||Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
141768|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 8 Hours [AUC (0-8)] for Cisplatin|AUC (0-8) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 8 hours (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 7 hr after start of infusion on Day 1 of Cycle 2 for cohort 8 and 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
141769|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Carboplatin|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141770|NCT00454649|Secondary|Plasma Clearance (CL) for Carboplatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
141771|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
141772|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Carboplatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
141773|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Carboplatin|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 5 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
141774|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Gemcitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141775|NCT00454649|Secondary|Plasma Clearance (CL) for Gemcitabine|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
141776|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
141777|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
145084|NCT00427635|Secondary|Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)|Number of reflux episodes based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Mean Number of Episodes||Standard Deviation|Mean
141778|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Gemcitabine|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4 hr after start of infusion on Day 1 of Cycle 2 for cohort 8|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
141779|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Capecitabine|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141780|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Capecitabine|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||Liter/hr||Standard Deviation|Mean
141781|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).||ng/mL||Standard Deviation|Mean
141782|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Capecitabine||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
141783|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Capecitabine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hr post-dose on Day 1 of Cycle 2 for cohort 6 and 7|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
141784|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Docetaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141785|NCT00454649|Secondary|Plasma Clearance (CL) for Docetaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
141786|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|Cmin was analyzed only for orally administered drugs.||ng/mL||Standard Deviation|Mean
141787|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Docetaxel||0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
141788|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Docetaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 5|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
141789|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Paclitaxel|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141790|NCT00454649|Secondary|Plasma Clearance (CL) for Paclitaxel|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the plasma.|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||L/hr||Standard Deviation|Mean
141792|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Paclitaxel||0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
141793|NCT00454649|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Paclitaxel|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 3.25, 3.5, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 1-3; 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 24, 30 hr after start of infusion on Day 1 of Cycle 2 for cohort 4|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
141794|NCT00454649|Secondary|Plasma Decay Half Life (t1/2) for Axitinib (AG-013736)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
141795|NCT00454649|Secondary|Apparent Oral Clearance (CL/F) for Axitinib (AG-013736)|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes and F is the absolute oral bioavailability. Apparent oral clearance(CL/F) is obtained following oral administration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||Liter/hour (L/hr)||Standard Deviation|Mean
141796|NCT00454649|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|Data was not summarized as majority of participants were having plasma concentrations below limit of assay quantification (BLQ).||ng/mL||Standard Deviation|Mean
141797|NCT00454649|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
141798|NCT00454649|Secondary|Area Under the Curve From Time Zero to Time 24 Hours [AUC (0-24)] for Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).|0 (pre-dose), 1, 2, 3, 4, 6, 8 hr post-dose on Day -1 for cohort 1, 2, 3, 5 and 8; on Day 22 of Cycle 1 for cohort 4; on Day 18 of Cycle 1 for cohorts 6 and 7; 0 (pre-dose), 1.2, 2.2, 3.2, 4.2, 6.2, 8.2 hr post-dose on Day -1 for cohort 9|The pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
141799|NCT00454649|Primary|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Chemotherapy|MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 nonhematological toxicities or >=0.5 teaspoon/day hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Baseline to withdrawal from study or Day 21 of Cycle 1 [all cohorts except cohort 4 (Day 28 of Cycle 1)]|Safety analysis population included all enrolled participants who received at least 1 dose of study medication.||mg BID|||Number
141800|NCT00454636|Secondary|Time to Response|Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.||days||Standard Deviation|Mean
141801|NCT00454636|Secondary|Duration of Response|Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication. Only participants who reported either a complete response or a partial response were assessed.||days||Standard Deviation|Mean
152430|NCT00365768|Primary|Incidence of Vincristine-induced Peripheral Neuropathy||Up to 30 weeks from baseline while on Vincristine treatment|||participants|||Number
141803|NCT00454636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
141804|NCT00454636|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.|Approximately 3.25 years|Intent-to-Treat (ITT) population: included all participants who received at least one dose of study medication and had baseline and at least one subsequent tumor assessment.||percentage of participants||95% Confidence Interval|Number
141805|NCT00454636|Primary|Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)||Approximately 3.25 years|Safety population: All participants who received at least one dose of study medication.||percentage of participants|||Number
141806|NCT00454584|Secondary|Difference in Psoriasis Area Severity Index Between Week 12 and That Achieved 12 Weeks After Retreatment (Week R12)|The difference between the PASI score at Week 12 and that achieved after 12 weeks of retreatment. The PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Up to Week 52. Retreatment may occur anytime between Week 16 and Week 40 depending on time of losing PGA response. Hence end of 12 weeks of retreatment would be between Week 28 and Week 52, inclusive.|Participants who were randomized to ustekinumab, had a PGA score less than or equal to 2 at Week 12, and were retreated upon losing PGA response (PGA greater than or equal to 3).||Score on a scale||Standard Error|Mean
141807|NCT00454584|Secondary|Number of Participants Achieving a Greater Than or Equal to 90 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 90) Score at Week 12|Number of participants achieving greater than or equal to 90 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst).|Baseline and Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. A participant is considered a non-responder if the participant has used any pre-specified prohibited medications, discontinued due to lack of efficacy, or had a missing Week 12 PASI score.||Participants|||Number
141808|NCT00454584|Secondary|Number of Participants With Physician's Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0-5) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trial of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All randomly assigned participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had a missing PGA score.||Participants|||Number
141809|NCT00454584|Primary|Number of Participants Achieving a Greater Than or Equal to 75 Percentage Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 12|Number of participants achieving greater than or equal to 75 percentage improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI is the widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) -72 (worst). Baseline visit refers to Week 0.|Baseline and Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participants is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or has missing data at Week 12.||Participants|||Number
141810|NCT00454571|Secondary|Median PSA Progression-free Survival|Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test. The outcome measure is median PSA progression-free survival time.|Time from randomization to PSA progression or death from any cause|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to PSA progression.|||||
141811|NCT00454571|Primary|Median Time to PSA Progression|The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.|Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment|Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to disease progression.|||||
141812|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Independent Radiology Assessment|2 months|||participants|||Number
141813|NCT00454532|Primary|Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)|Best Overall Tumor Response - Investigator Assessment|2 Months|||participants|||Number
141814|NCT00454532|Primary|Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)|Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0|Monthly|||participants|||Number
141815|NCT00454363|Secondary|Change in Tumor Blood Flow Assessed by Functional CT||Baseline and week 12||||||
141816|NCT00454363|Secondary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death.|Baseline to 18 months.|Analysis calculated according to intent to treat.||months||95% Confidence Interval|Median
141817|NCT00454363|Secondary|Plasma Trough Level of GW786034||Baseline and day 28||||||
141818|NCT00454363|Primary|Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 18 months|RECIST best protocol response by intention to treat. Four participants were not evaluable for response.||participants|||Number
141819|NCT00454246|Secondary|Number of Participants Assessed for AEs and SAEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|First dose of medication through 15 days post last dose (up to 8 months)|Safety Population||participants|||Number
141820|NCT00454246|Secondary|Dose Adjustments|Efficacy analyses were not performed.|5 months post-randomization through onset of dialysis, and post-dialysis initiation through study end.|||participants|||Number
141821|NCT00454246|Primary|Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL|Efficacy analyses were not performed.|6-7 months post initiation of dialysis|||percentage of participants|||Number
141822|NCT00454207|Secondary|Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality.|Baseline up to 1.3 years|All subjects who received at least one dose of the study medication and had any evaluable laboratory test data after treatment.||participants|||Number
141823|NCT00454207|Secondary|The Average Plasma Trough Concentration (Ctrough) of Sildenafil|The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanograms/milliliter||Standard Deviation|Mean
141824|NCT00454207|Secondary|The Average Plasma Concentration (Css,av) of Sildenafil at Steady State|The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanograms/milliliter||Standard Deviation|Mean
141825|NCT00454207|Secondary|The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320|The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanogram*hour/milliliter||Standard Deviation|Mean
141826|NCT00454207|Secondary|Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||hours||Standard Deviation|Mean
141827|NCT00454207|Secondary|Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320|Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant|Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing|||nanograms/milliliter||Standard Deviation|Mean
141828|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II|Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||picograms/milliliter||Standard Deviation|Mean
141829|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||scores on a scale||Standard Deviation|Mean
141830|NCT00454207|Secondary|Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||participants|||Number
141831|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||meters||Standard Deviation|Mean
141832|NCT00454207|Secondary|Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline|Baseline, Week 4, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).||picograms/milliliter||Standard Deviation|Mean
141847|NCT00454207|Secondary|Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|"Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3.~Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline."|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141833|NCT00454207|Secondary|Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I|Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.|Baseline, Week 8, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).||scores on a scale||Standard Deviation|Mean
141834|NCT00454207|Secondary|Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I|The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||participants|||Number
141835|NCT00454207|Secondary|Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141836|NCT00454207|Secondary|Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141837|NCT00454207|Secondary|Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||percent saturation||Standard Deviation|Mean
141838|NCT00454207|Secondary|Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||percent saturation||Standard Deviation|Mean
141839|NCT00454207|Secondary|Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.|baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
141840|NCT00454207|Secondary|Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne*second/centimeter^5||Standard Deviation|Mean
141841|NCT00454207|Secondary|Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne*second/centimeter^5/meter^2||Standard Deviation|Mean
141842|NCT00454207|Secondary|Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||beats/minute||Standard Deviation|Mean
141843|NCT00454207|Secondary|Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac index at Week 12 minus cardiac index at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||liter/minute/meter^2||Standard Deviation|Mean
141844|NCT00454207|Secondary|Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141845|NCT00454207|Secondary|Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141846|NCT00454207|Primary|Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Cardiac output at Week 12 minus cardiac output at baseline|Baseline, week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||liter/minute||Standard Deviation|Mean
150889|NCT00380250|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
141848|NCT00454207|Secondary|Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141849|NCT00454207|Secondary|Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141850|NCT00454207|Secondary|Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141851|NCT00454207|Secondary|Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141852|NCT00454207|Secondary|Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I|"Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline.~The 6-minute walk distance:Total distance walked during the 6- minute walk test."|Baseline, Week 8|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline.||meters||Standard Deviation|Mean
141853|NCT00454207|Primary|Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||dyne·second/centimeter^5||Standard Deviation|Mean
141854|NCT00454207|Primary|Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||mmHg||Standard Deviation|Mean
141855|NCT00454207|Primary|Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I|Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.|Baseline, Week 12|Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.||meters||Standard Deviation|Mean
141856|NCT00454194|Secondary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.|Up to 5 years|All participants who met the eligibility criteria and started the treatment.||percentage of participants|||Number
141857|NCT00454194|Secondary|Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.|Up to 3 years|All participants who met the eligibility criteria and started the treatment.||participants|||Number
141858|NCT00454194|Secondary|Duration of Response|Duration of response was defined as the time from the date at which the patient’s earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.||months||95% Confidence Interval|Median
141859|NCT00454194|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from date of randomization to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or other medical problems.|Up to 5 years|All participants who met the eligibility criteria and ended the treatment.||months||95% Confidence Interval|Median
141860|NCT00454194|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.|Time from randomization to death or last follow-up (up to 5 years)|All participants who met the eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
141861|NCT00454194|Primary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from randomization to the disease progression or death (up to 5 years)|All participants who met the eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
141862|NCT00454181|Secondary|Investigator Assessment Regarding Global Oral Changes.|"Number of subjects with improvement from baseline to week 24 in global oral health as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment|||participants|||Number
141863|NCT00454181|Secondary|Investigator Assessment Regarding Changes in Warts|"Number of subjects with improvement in oral warts from baseline to week 24 as rated by the attending investigator. Scale was subjective with 3 choices: improved, worsened, or unchanged."|24 weeks, from baseline to the end of treatment|||participants|||Number
152526|NCT00365105|Secondary|Changes in Pain Control as Measured by Brief Pain Inventory (BPI)||From pre-treatment to 1 year||||||
141872|NCT00454142|Secondary|Pharmacokinetic Study: Percentage of Participants With Trough Concentration at Steady State (Day 28) Above 15 µg/mL|Pazopanib pharmacokinetic parameters were estimated on Day 1 and Day 28 (steady state). Trough concentration of pazopanib was measured on Day 28 with blood sampling at zero (pre dose), 0.5 hr, 1, 2, 3, 4, 5, 6, 8 and 24 hrs after Day 28 dose.|Day 28 of treatment|Patients (total 26) with both Day 1 and Day 28 pharmacokinetic parameters were included.The trough concentration of pazopanib on Day 28 was observed to be above 15ug/ml in approximately 92% of patients at steady state.||percentage of participants|||Number
141873|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow on Day 28|DCE-CT was performed on Day 28 and tumor blood flow was measured. 19 of 33 patients had evaluable DCE-CT data.|28 days post treatment|||ml/100ml/min||Standard Deviation|Mean
141874|NCT00454142|Secondary|Pharmacodynamic Study: Tumor Blood Flow at Baseline|Dynamic-contrast enhanced computed tomography (DCE-CT) was performed at baseline and Day 28, tumor blood flow was measured.19 of 33 patients had evaluable DCE-CT data.|Pretreatment|||ml/100ml/min||Standard Deviation|Mean
141875|NCT00454142|Secondary|Toxicity Profile: Percentage of Participants With Significant (Grade 3/4) Related Adverse Event (AE)|The frequencies of grade 3/4 related toxicities were recorded among all participants, and the percentage of participants who experienced significant AEs were reported.|From the time of first treatment with pazopanib hydrochloride to up to 30days after completion of treatment|||percentage of participants|||Number
141876|NCT00454142|Secondary|Overall Survival||From date of enrollment to the study to the date of death from any cause or to the date when the patient was last known to be alive, up to 3 years.|||months||95% Confidence Interval|Median
141877|NCT00454142|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST ver 1.0) and assessed by CT or MRI. CBR includes 1) Complete response (CR): disappearance of all lesions; 2) partial response (PR): >=30% decrease in the sum of the longest diameter of target lesions and 3) stable disease (SD): non-PR and non progressive disease.|12 weeks of treatment|||percentage of participants||95% Confidence Interval|Number
141878|NCT00454142|Secondary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by RECIST Committee. The sample proportion and associated 95% confidence interval will be reported.|From the date of enrollment to the date of first documented progression or death, whichever occurs first, or to the date when the patient was last known to be alive, up to 3 years.|||months||95% Confidence Interval|Median
141879|NCT00454142|Secondary|Response Rate (PR)|Per response evaluation criteria in solid tumors (RECIST v1.0) and assessed by MRI or CT: Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-PD (PD: progressive disease) of non-target lesions.|12 weeks of treatment|||percentage of participants|||Number
141880|NCT00453362|Secondary|Number of Participants With Adverse Events Due to FLT-PET Imaging|The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.|From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.|Patients with non−small cell lung cancer (NSCLC) who underwent FLT-PET scans.||Participants|||Number
141881|NCT00453362|Primary|Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans of <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib,underwent all FLT-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."||months||Full Range|Median
141882|NCT00453362|Primary|Overall Survival of Groups by FLT Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.||months||Full Range|Median
141883|NCT00453362|Primary|Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|From first erlotinib treatment to death, assessed up to 2 years|"Patients who were treated with erlotinib, underwent all FDG-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."||months||Full Range|Median
141884|NCT00453362|Secondary|FLT Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans <−25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
152527|NCT00365105|Secondary|Changes in Quality of Life as Measured by FACT-G||From pre-treatment to 1 year||||||
141885|NCT00453362|Secondary|FDG Response in Subgroups by CT Response at Day 56|"In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans <−25%.~CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD.~CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions."|Day 56|FDG−Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
141886|NCT00453362|Primary|Overall Survival of Groups by FDG Response at Day 56|"Overall survival (OS) was defined as the time from the date of first erlotinib dose to death.~Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%."|From first erlotinib treatment to death, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.||months||Full Range|Median
141887|NCT00453362|Primary|Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."||weeks||Full Range|Median
141888|NCT00453362|Primary|Progression Free Survival of Groups by FLT Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.||weeks||Full Range|Median
141889|NCT00453362|Secondary|Percentage of Patients With FLT-PET Responses|"In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FLT-PET response was defined as a mSUVmax from FLT-PET scans <−25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FLT−Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
141890|NCT00453362|Primary|PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of <−25% and FDG-PET disease progression; defined as a mSUVmax >+25% or the development of a new lesion with a mSUVmax above background not explained by another cause."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|"FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start."||weeks||Full Range|Median
141891|NCT00453362|Secondary|Percentage of Patients With FDG-PET Responses|"In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment.~FDG-PET response was defined as a mSUVmax from FDG-PET scans <−25%.~CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started."|Day 14 and Day 56|FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.||Percentage of Participants||95% Confidence Interval|Number
141892|NCT00453362|Primary|Progression Free Survival (PFS) of Groups by FDG Response at Day 56|"PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first.~PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib.~Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax <-25%."|Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years|FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.||weeks||Full Range|Median
141894|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures.||participants|||Number
141895|NCT00453349|Secondary|Bacteriological Response at Follow-up Visit Microbiologically Valid|Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.|28 - 42 days after completion of study drug therapy|At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures.||participants|||Number
141896|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Intent To Treat Population|"All successfully treated subjects and subjects evaluated asindeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes."|28 - 42 days after completion of study drug therapy|At the follow-up visit, the clinical response in subjects who were non-failures at the TOC visit were graded as Continued cure, Clinical relapse or Indeterminate.||participants|||Number
141897|NCT00453349|Secondary|Clinical Response at Follow-up Visit on Per Protocol Population|Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.|28 - 42 days after completion of study drug therapy|"All successfully treated subjects and subjects evaluated as indeterminate at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow up visit. Patients with missing or indeterminate outcome were omitted."||participants|||Number
141898|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism|Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.|7 - 14 days at TOC visit|Patients were included in this analysis if a causative organism could be established pre-therapy by culture or PCR, and if the patient was valid for intent-to-treat.||participants|||Number
141899|NCT00453349|Secondary|Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid|The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.|7 - 14 days at TOC visit|All subjects for whom a specific bacterial pathogen was isolated/identified from any pre-treatment culture and which was considered responsible for the infection would be assessed for bacteriological efficacy.||participants|||Number
141900|NCT00453349|Secondary|Clinical Response on Treatment for Intent To Treat Population|Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.|4 - 7 days after start of therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis. For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis.||participants|||Number
141901|NCT00453349|Secondary|Clinical Response on Treatment for Per Protocol Population|At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by >30% with improvement in temperature, clinical failure (reduction in severity score of < or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).|4 - 7 days after start of therapy|Analysis was performed for the per protocol population.||participants|||Number
141902|NCT00453349|Secondary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population|"For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to non-success."|7 - 14 days after completion of study drug therapy|Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis.||participants|||Number
141903|NCT00453349|Primary|Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population|Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.|7 - 14 days after completion of study drug therapy|The number of subjects in the PP population was slightly higher than the planned number of subjects (184 subjects per treatment group). The most common reasons for exclusion from the population valid for efficacy in both the Moxifloxacin and Comparator were essential data missing/invalid, followed by violation of inclusion/exclusion criteria.||participants|||Number
141904|NCT00453336|Primary|Number of Participants Experiencing Adverse Events|Number of participants enrolled experiencing serious adverse events and/or other non-serious events|6 months|||participants|||Number
141905|NCT00453336|Primary|Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment|Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.|6 months|||participants|||Number
141906|NCT00453310|Primary|Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment||2 years|||participants|||Number
141907|NCT00454116|Primary|Number of Patients With an Objective Disease Progression Event|Number of patients with objective disease progression or death (by any cause in the absence of objective progression)|Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days)|||Participants|||Number
141908|NCT00454051|Secondary|Physician's Overall Assessment of Treatment Effectiveness|The Physician's overall assessment of treatment effectiveness was graded 1-5 as 1 = Excellent asthma control (complete control) 2 = Good asthma control (marked improvement) 3 = Moderate asthma control (discernible, but limited improvement) 4 = Poor asthma control (no appreciable change) 5 = Very poor asthma control (worsening)|After 16 weeks of treatment|The ITT population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained. Complete data for 26 of the total 30 participants was recorded.||participants|||Number
141909|NCT00454051|Secondary|Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)|Peak Expiratory Flow (PEF) was measured every morning using a peak flow meter, and was recorded in the patient diary. For this analysis, the mean morning PEF during the 4-week screening period prior to randomizaton is compared with the mean morning PEF during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||liters per minute||Standard Deviation|Mean
141910|NCT00454051|Secondary|Change From Baseline in the Number of Unscheduled Clinic Visits|Participants maintained a diary to record the number of unscheduled clinic visits during the study. For this analysis, the number of unscheduled visits during the 4 week screening period prior to randomization is compared with the number of unscheduled visits during the last 4 weeks on treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||unscheduled visits||Standard Deviation|Mean
141911|NCT00454051|Secondary|Change From Baseline in the Number of Days With Hospitalizations|Participants maintained a diary to record the number of days with hospitalizations during the study. For this analysis, the number of days with hospitalizations during the screening period (4 weeks prior to randomization) was compared with the number of days with hospitalizations during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days||Standard Deviation|Mean
141912|NCT00454051|Secondary|Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms|Participants maintained a diary to record the number of days with absence from school or work due to asthma symptoms. For this analysis, the number of days with absence from school or work in the four weeks prior to randomization (screening period) were compared with the number of absence days during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days||Standard Deviation|Mean
141913|NCT00454051|Secondary|Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week|"Impairment was defined as days with physical activity considered as limited (or not normal) according to patient's assessment and was recorded in a patient daily diary. For this analysis, the mean number of days with impairment per week during the 4 week screening period prior to randomization was compared with the mean number of days with impairment per week during the last 4 weeks on study treatment (Weeks 12 - 16)."|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days per week||Standard Deviation|Mean
141914|NCT00454051|Secondary|Change From Baseline in the Number of Nights With Awakenings Per Week|Participants maintained a diary to record the number of nights with awakenings due to asthma symptoms per week. For this analysis, the mean number of nights with awakenings per week during the 4 week screening period prior to randomization was compared with the mean number of nights with awakenings per week during the last 4 weeks of study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||nights with awakenings per week||Standard Deviation|Mean
141915|NCT00454051|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Week|Participants maintained a diary to record the daytime number of puffs of rescue Short-acting B2 agonist (SABA) used to treat asthma symptoms per week. This analysis compares the mean number of puffs of rescue medication per week during the 4 week screening period prior to randomization to the mean number of puffs per week during the last 4 weeks on study treatment (Weeks 12 - 16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||puffs per week||Standard Deviation|Mean
141916|NCT00454051|Primary|Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.||percent change in fluorescence intensity||Standard Deviation|Mean
152528|NCT00365105|Secondary|Overall Survival||From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome.||||||
141917|NCT00454051|Secondary|Change From Baseline in the Number of Days With Asthma Symptoms Per Week|Participants maintained a diary to record the number of days with daytime asthma symptoms per week. This analysis compares the mean number of days per week with asthma symptoms during the 4-week screening period prior to randomization with the mean number of days per wek with asthma symptoms in the last 4 weeks of study treatment (Weeks 12 -16).|Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16)|The intent-to-treat population included all randomized participants who received at least one dose of study drug and from whom at least one efficacy measurement was obtained.||days per week||Standard Deviation|Mean
141918|NCT00454051|Secondary|Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12, and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.||% change in fluorescence intensity||Standard Deviation|Mean
141919|NCT00454051|Secondary|Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment|Blood was drawn from a sub-group of participants at weeks 4, 8, 12, and 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the specified time point, expressed as a percent of the baseline value.|Baseline, Weeks 4, 8, 12 and 16|A subset of the ITT population analyzable for FcεRI expression at select sites had repeat measurements of FcεRI expression at all time points.||percent change in cells expressing FcεRI||Standard Deviation|Mean
141920|NCT00454051|Primary|Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo|Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.|Baseline and Week 16|The Intent-to-treat (ITT) population analyzable for FcεRI expression was a subset of the ITT population and included the 27 participants with accurate measurements before and after 16 weeks of treatment.||percent change in FcεRI expression||Standard Deviation|Mean
141921|NCT00453999|Secondary|Change in Amount of Influenza Virus in Nose and Throat (Influenza A and B Combined)|Reduction in viral shedding, assessed as the change in quantitative viral titers and defined as the time-weighted change from baseline in TCID50/mL, was summarized for each treatment group.|Baseline, and 12, 24, 36, 48, 72, and 96 hours|Among the 122 subjects with confirmed influenza (intent-to-treat infected [ITTI]) population, a total of 112 subjects had positive virus cultures obtained from baseline nasopharyngeal specimens.||log10 TCID50/mL||Standard Deviation|Mean
141922|NCT00453999|Secondary|Time to Hospital Discharge (Kaplan-Meier Estimate)|Time to discharge from hospital was estimated using the method of Kaplan Meier. Subjects who were not discharged from the hospital were censored at the time of their last assessment.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||hours||95% Confidence Interval|Median
141923|NCT00453999|Secondary|Incidence of Clinical Relapse of Influenza After Treatment (Number of Participants Experiencing Relapse During the Study)|The number of subjects with clinical relapse, defined as changes in 2 or more signs of clinical stability to values outside the range of normalization criteria for a duration of at least 12 consecutive hours after clinical stability had been attained, were summarized by treatment group.|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||participants|||Number
141924|NCT00453999|Secondary|Time to Resumption of Ability to Perform Usual Activities (Kaplan-Meier Estimate)|Changes in each subject’s ability to perform usual activities as determined from the visual analog scale (0 to 10, where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully) were summarized by study visit and treatment group. The time to resumption of a subject’s ability to perform usual activities was estimated using the method of Kaplan Meier. Subjects who did not return to the pre-study level of performance of usual activities were censored at the time of their last assessment. (Note: N is the number of ITTI participants with available data).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||hours||95% Confidence Interval|Median
141925|NCT00453999|Secondary|Change From Baseline in Scores of Symptoms of Influenza|Descriptive statistics for the change from baseline in each of the 7 symptoms of influenza (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue, each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]) were tabulated by treatment group. Missing data were excluded.|Baseline, Days 2, 3, 4, 5, 10, and 14|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||units on a scale||Standard Deviation|Mean
150890|NCT00380250|Secondary|Month 2 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
141926|NCT00453999|Primary|Time to Clinical Stability (Kaplan-Meier Estimate)|Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).|14 days|The intent-to-treat infected (ITTI) population included all subjects who were randomized, received at least 1 dose of study drug, and had confirmed influenza infection by viral culture, PCR, and/or paired acute and convalescent serology specimens that demonstrated at least a 4-fold increase in antibody titer against influenza A or B.||hours||95% Confidence Interval|Median
141927|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141928|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort|An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141929|NCT00453986|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141930|NCT00453986|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141931|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort|AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141932|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141933|NCT00453986|Secondary|Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141934|NCT00453986|Secondary|Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141935|NCT00453986|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141983|NCT00453102|Secondary|5-Year Rate of Progression-Free Survival (5-Year PFS)|Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.|5 Years|||percentage of participants||90% Confidence Interval|Number
141936|NCT00453986|Secondary|Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|From Dose 1 (at Month 0) up to study end (at Month 6)|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141937|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort|Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = > 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141938|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature > 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141939|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.|During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141940|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|During the 4-day (Days 0-3) follow-up period after meningococcal vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141941|NCT00453986|Secondary|Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|During the 4-day (Days 0-3) follow-up period after vaccination|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
141942|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
141943|NCT00453986|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141944|NCT00453986|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
152529|NCT00365105|Secondary|SRE Rate at 1 Year||From randomization to 1 year||||||
141945|NCT00453986|Secondary|Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 & PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141946|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
141947|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort|Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141948|NCT00453986|Secondary|Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
141949|NCT00453986|Secondary|Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||subjects|||Number
141950|NCT00453986|Secondary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer >1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141951|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
141952|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141984|NCT00453102|Secondary|Rate of Progression-Free Survival|The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.|End of study.|||months||Full Range|Median
141985|NCT00453102|Primary|Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.|The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.|12 weeks post-therapy|||percentage of participants||90% Confidence Interval|Number
141953|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
141954|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141955|NCT00453986|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to vaccination (at Month 0).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
141956|NCT00453986|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.|Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141957|NCT00453986|Primary|Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141958|NCT00453986|Primary|Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Fold increase in serum HI GMTs||95% Confidence Interval|Mean
141959|NCT00453986|Primary|Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|"Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer >1:40, or a pre-vaccination titer >1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain.~Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B."|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141960|NCT00453986|Primary|Number of Subjects With Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.|Prior to and one month after vaccination (at Month 0 and Month 1).|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
141961|NCT00453986|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)|Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
142645|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
141962|NCT00453986|Primary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.|Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Subjects|||Number
141963|NCT00453986|Primary|Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.|Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.|One month after vaccination (at Month 1)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.||Titers||95% Confidence Interval|Geometric Mean
141964|NCT00453973|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Final Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change||percentage of participants|||Number
141965|NCT00453206|Secondary|Treatment-related Mortality at 100 Days After Transplantation||100 days||||||
141966|NCT00453206|Secondary|Quality of Life at the Time of Transplantation||baseline||||||
141967|NCT00453206|Secondary|Iron Status at the Time of Transplantation||baseline||||||
141968|NCT00453206|Secondary|Graft-versus-host Disease||monthly||||||
141969|NCT00453206|Secondary|Disease-free Survival||monthly||||||
141970|NCT00453206|Secondary|Overall Survival||monthly||||||
141971|NCT00453206|Secondary|Complete Response||monthly||||||
141972|NCT00453206|Primary|Treatment-related Mortality Within the First 6 Months After Transplantation||6 months|||participants|||Number
141973|NCT00453193|Primary|Number of Participants With Objective Response|Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.|After a maximum of 6 months of therapy maintained for one month.|Analysis was per protocol.||Participants|||Number
141974|NCT00453154|Other Pre-specified|Change in Plasma Levels of PDGF|Correlated with clinical outcome (response and survival).|Baseline to within 7 days of sunitinib/placebo therapy discontinuation||||||
141975|NCT00453154|Other Pre-specified|Change in Plasma Levels of VEGF Prior to, During Single-agent, and Following Treatment With Sunitinib Malate|The frequency of tumor response by the optimally dichotomized VEGF levels will be tabulated and their association will be tested by Fisher’s exact test as well as the maximally selected rank test. The association of the VEGF levels as continuous predictor with tumor response will be tested by Wilcoxon rank sum test. Further assessments of the association of the VEGF levels as > continuous or binary variables and the tumor response will be implemented in a logistic regression while adjusting for other covariates such as performance status, weight loss and age|Baseline to within 7 days of sunitinib/placebo therapy discontinuation||||||
141976|NCT00453154|Secondary|Number of Participants With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs.|Up to 3 years|Participants who were randomized to maintenance were analyzed.||participants|||Number
141977|NCT00453154|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.||months||95% Confidence Interval|Median
141978|NCT00453154|Primary|Progression-free Survival (Phase II)|Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Up to 3 years|Participants who were randomized to maintenance were analyzed.||months||95% Confidence Interval|Median
141979|NCT00453154|Primary|Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)|The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy).|21 days|Due to safety concerns, the study committee discontinued sunitinib from combination chemotherapy to study single agent sunitinib in the maintenance setting.||mg/day|||Number
141980|NCT00453102|Secondary|Number of Participants With Unacceptable Toxicity.|Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.|Up to 12 weeks post-therapy|||participants|||Number
141981|NCT00453102|Secondary|5 Year Rate of Overall Survival (5-Year OS)|Percentage of participants still alive five years after the date of protocol therapy initiation.|5 Years|||percentage of participants||90% Confidence Interval|Number
141986|NCT00453063|Secondary|Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15|Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||liters/minute||Standard Deviation|Least Squares Mean
141987|NCT00453063|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)|The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants.|Baseline and 15 days|The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group.||units on a scale||Standard Deviation|Least Squares Mean
141988|NCT00453063|Secondary|Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15|Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||units on a scale||Standard Deviation|Least Squares Mean
141989|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15|TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||units on a scale||Standard Deviation|Least Squares Mean
141990|NCT00453063|Primary|Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15|TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.|Baseline and 15 days|All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation.||units on a scale||Standard Deviation|Least Squares Mean
141991|NCT00452868|Primary|Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks|Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.|24 weeks|||units on a scale||Standard Deviation|Mean
141992|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the toddler dose(12 months of age)|Safety population: all participants who received toddler dose vaccination (12 months of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
141993|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received dose 3 of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
141994|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received dose 2 of the infant series vaccination (10 weeks of age); n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
141995|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)|Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received at least dose 1 of the infant series vaccination (after 6 weeks. n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
142350|NCT00448682|Secondary|Overall Rate of Survival|Patients will be followed for overall survival from date of enrollment to date of death or last contact. The extent of follow up will be described by the range and median for deceased patients and for those alive at last follow up. We will estimate the 1 year survival rates by the Kaplan-Meier method.|1 year|The study data has not been analyzed.|||||
141996|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the toddler dose (12 months of age)|Safety population: all participants who received toddler dose vaccination(after 12 months). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
141997|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)|Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 3 of the infant series (14 weeks of age)|Safety population: all participants who received all 3 doses of the infant series vaccination (14 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
141998|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 2 of the infant series (10 weeks of age)|Safety population: all participants who received the first 2 doses of the infant series vaccination (10 weeks of age).n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
141999|NCT00452790|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 4 days after the dose 1 of the infant series (6 weeks of age)|Safety population: all participants who received dose 1 of the infant series vaccination (6 weeks of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.||Percentage of participants|||Number
142000|NCT00452790|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.|1 month after toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
142001|NCT00452790|Secondary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||Percentage of participants||95% Confidence Interval|Number
142002|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay [ELISA] units per mL [EU/mL]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.||Percentage of participants||95% Confidence Interval|Number
142003|NCT00452790|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series|Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.|1 month after the 3-dose infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
142043|NCT00452400|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
142351|NCT00448682|Primary|Number of Patients Achieving Clinical Response|Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.|1 year|The study data has not been analyzed.|||||
142004|NCT00452790|Primary|Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.|Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.|1 month after the infant series (18 weeks of age)|Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations. n=number of participants with determinate IgG antibody concentration for the specified serotype.||Percentage of participants||95% Confidence Interval|Number
142005|NCT00452699|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a 20% decrease in AM PEF, a 70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population||attacks per participant per year||95% Confidence Interval|Mean
142006|NCT00452699|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided||Percentage of symptom-free days||Standard Error|Mean
142007|NCT00452699|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values||Liters/minute (L/min)||Standard Error|Mean
142008|NCT00452699|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug||Liters||Standard Error|Mean
142009|NCT00452673|Secondary|Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|CTC, Version 3 used to assess parameters. (ULN)=upper limit of normal: (ALT)= alanine transaminase; (AST)=aspartate aminotransferase; (ALP)=alkaline phosphatase. ALT Grade (Gr)1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10.0*ULN; Gr 4: >10.0*ULN. ALP (U/L) Gr1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Gr 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Gr 3: < 2 g/dL to <2 g/L. Participants with a baseline chemistry lab value of Gr 0 but who had Gr 3 - 4 chemistry value while on-study are presented below.|Day 1 to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.||participants|||Number
142010|NCT00452673|Secondary|Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population|National Cancer Institute Common terminology criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN). CTC criteria: Absolute neutrophil count (ANC). Leukocytes (White blood cells) Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Participants with a baseline hematology lab value of Gr 0 but who had Gr 3 - 4 hematology value while on-study are presented below.|Day 1 up to 30 days post last dose|Safety Population: All participants with at least 1 dose of study drug. N=number of participants with Grade 0 values at baseline in each dosing arm, respectively.||participants|||Number
142011|NCT00452673|Secondary|Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population|Objective response rate was the percentage of participants, (n/N; number with objective response per Number evaluated) whose best response is either a Complete Response (CR) or a Partial Response (PR). Disease control rate was defined as percentage (n/N) of participants with stable disease greater than (>) 6 months, PR, or CR. Efficacy Evaluable Population: All participants with at least one measurable lesion at baseline, who received at least one dose of combination study drug and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stop treatment prior to tumor assessment for reasons unrelated to disease or drug were excluded.|Day 1 up to 30 days post last dose|n=number of participants with ORR: 2, 1, 0, 6 in dosing arms 1, 2, 3, and 4, respectively. n= number of participants with Disease control: 3, 2, 2, 14 in dosing arms 1, 2, 3, and 4, respectively.||percentage of participants||95% Confidence Interval|Number
142026|NCT00452452|Primary|Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
142012|NCT00452673|Secondary|Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population|Complete Response (CR): disappearance of all target and non-target lesions, with confirmation at >=4 weeks interval; Partial Response (PR): >= 30% decrease in sum of longest diameter (LDs) of target lesions, taking as reference the baseline sum LD, with confirmation at >= 4 weeks interval. Progressive Disease (PD): Appearance of new lesion(s), or >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, without unequivocal progression of non-target lesions, after >=6 weeks on study. Radiological tumor assessment by computed tomography (CT) or magnetic resonance imaging (MRI) occurred every 6 weeks. For those patients who were on treatment > 24 weeks, the tumor assessment occurred every 9 weeks.|Day 1 to 30 days post last dose|All participants with at least one measurable lesion at baseline, who received at least one dose of the combination therapy and have at least one on-study tumor assessment or stopped study treatment prior to first assessment, were evaluated. Those who stopped drug prior to tumor assessment for reasons unrelated to disease or drug were excluded.||participants|||Number
142013|NCT00452673|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population|Adverse events (AEs) were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious AE (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Day 1 up to 30 days post last dose|Safety Population: all participants receiving at least one dose of study drug.||participants|||Number
142014|NCT00452673|Primary|Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population|Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.|Day 1 to 30 days post last dose|Safety Population: All participants who received at least one dose of study drug. DLTs: Grade 3 headache, Grade 3 pneumonia, Grade 3 diarrhea in Dosing arms, 1, 2, and 3, respectively. DLTs in dose arm 4: 1 participant with Grade 3 pneumonia and pain and 1 participant with Grade 4 neutropenia and diarrhea plus Grade 3 vomiting and mucositis.||participants|||Number
142015|NCT00452543|Primary|Total Drinks Consumed Per Drinking Day on the TLFB|Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|||Drinks consumed per drinking day||Standard Deviation|Mean
142016|NCT00452543|Primary|Total Drinks Consumed Per Week on the TLFB|Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|||Drinks consumed per week||Standard Deviation|Mean
142017|NCT00452543|Primary|Total Drinking Days on the Alcohol Timeline Followback (TLFB)|The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit.|From Baseline visit to Week 12 (or early discontinuation visit)|Intent to treat sample||Drinking days||Standard Deviation|Mean
142018|NCT00452543|Primary|Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)|Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit.|From baseline visit to Week 12 (or early discontinuation visit)|||Scores on a scale||Standard Deviation|Mean
142019|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)|preRX=pretreatment. Blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; glucose, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; protein, urine: If missing preRx use ≥ 2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; Red blood cells , urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; white blood cells, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements||Participants|||Number
142027|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine.||percentage of participants|||Number
142020|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRx<LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx<LLN use <0.9*preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; bicarbonate (mEq/L): <0.75*LLN or >1.25*ULN, or if preRx < LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or < LLN; potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRx<LLN use <0.9 *preRx or >ULN if preRx>ULN use >1.1*preRx or <LLN; sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRx <LLN use <0.95*preRx or >ULN if preRx>ULN use >1.05*preRx or <LLN; protein, total (g/dL): <0.9*LLN or >1.1*ULN, or if preRx <LLN use 0.9*preRx or >ULN if preRx >ULN use 1.1*preRx or <LLN; CK (U/L): >5*ULN; uric acid (mg/dL): >1.5*ULN, or if preRx >ULN use >2*preRx; glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRx <LLN use <0.8*preRx or >ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements||Participants|||Number
142021|NCT00452530|Other Pre-specified|Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal; abs=absolute. Hemoglobin (g/dL): >2 decrease from preRx value or value <=8; hematocrit (%): <0.75*preRx; platelets: <100*10^9 cells/L; erythrocytes (*10^6 cells/μL): <0.75*preRx; leukocytes: <0.75*LLN or >1.25*ULN, or if preRx <LLN, use <0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; abs basophils: >400/mm^3; abs eosinophils: > 0.750*10^3 cells/µL; abs lymphocytes: <0.750*10*3 cells/ µL or >7.50*10^3 c/ µL; abs monocytes > 2000/mm^3; abs neutrophils: <1.0*10^3 cells/μL; ALP (U/L): >2*ULN; ALT, AST (U/L): >3*ULN; U/L; bilirubin, direct (mg/dL): >1.5*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN.|Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up|All participants who received at least 1 dose of study drug. n=number of participants with available measurements||Participants|||Number
142022|NCT00452530|Secondary|Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Bleeding AEs=all serious or nonserious bleeding-related AEs.|Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
142023|NCT00452530|Primary|Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization.Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug|The primary efficacy data set (all randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, an adjudicated venous thrombolytic event; or died due to any cause.)||Percentage of events/patients evaluated||95% Confidence Interval|Number
142024|NCT00452530|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM|Event rate=Number of events divided by number of patients evaluated. Adjusted difference of event rates takes into consideration type of surgery as a stratification factor. Bleeding Criteria: Major bleeding=an event consisting of clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. CRNM bleeding= clinically overt bleeding; that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event; that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding; or a change in antithrombic treatment.|Days 1 to 12|All participants who received at least 1 dose of study drug||Percentage of events/patients evaluated||95% Confidence Interval|Number
142025|NCT00452530|Secondary|Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Intended treatment period starts on the day of randomization, and for those who received study drug, ends at the later of 2 days after last dose or 14 days after the first dose of study drug; for randomized patients who did not receive study drug, the period ends 14 days after randomization; for randomized patients who did not receive study drug, the period ends 14 days after randomization. Venous thromboembolic event (VTE)=nonfatal pulmonary embolism (PE), symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death=fatal PE or sudden death for which VTE could not be excluded as a cause.|Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period||Percentage of events/patients evaluated||95% Confidence Interval|Number
142028|NCT00452452|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine.||percentage of participants|||Number
142029|NCT00452452|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
142030|NCT00452426|Secondary|Recovery Time (From Sedation)|Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.|"from scope out until first of two consecutive MOAA/S scores of 5"|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||minutes||Standard Deviation|Mean
142031|NCT00452426|Secondary|Clinician Satisfaction|Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|Post procedure|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||Scores on a scale||95% Confidence Interval|Mean
142032|NCT00452426|Secondary|Patient Satisfaction|Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.|24-48 hours post sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||Scores on a scale||95% Confidence Interval|Mean
142033|NCT00452426|Secondary|Duration of Deep Sedation/General Anesthesia|Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.|From first dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||minutes||Standard Deviation|Mean
142034|NCT00452426|Primary|Area Under the Curve for Oxygen Desaturation (AUCDesat)|AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds*percent.|From administration of initial drug dose until subject recovered from effects of sedation|This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.||seconds*percent of oxygen desaturation||95% Confidence Interval|Mean
142035|NCT00452400|Secondary|Laboratory Testing: Average Change From Baseline of Potassium|Laboratory testing: Average change from baseline of potassium measured on test-days. Pre−dose value on test day 1 is the baseline value.|Baseline and day 29|Treated set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||mmol/L||Inter-Quartile Range|Geometric Mean
142036|NCT00452400|Secondary|Clinical Relevant Abnormalities for Vital Signs, ECG and Physical Examination|Clinical relevant abnormalities for vital signs, ECG and physical examination. Any new or clinically relevant worsening of baseline conditions was reported as adverse events.|4 weeks|Treated set including all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.||participants|||Number
142037|NCT00452400|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||hours||Full Range|Median
142038|NCT00452400|Secondary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
142039|NCT00452400|Secondary|Area Under Curve From 0 to 24 Hours at Steady State (AUC0-24,ss)|AUC0-24,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=24 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
142040|NCT00452400|Secondary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=6 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
142041|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours at Steady State (AUC0-3,ss)|AUC0-3,ss represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3 at steady state.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
142044|NCT00452400|Secondary|Area Under Curve From 0 to 3 Hours (AUC0-3)|AUC0-3 represents the area under the concentration curve of olodaterol and olodaterol glucuronide in plasma from 0 to time t=3.|Baseline and 4 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
142045|NCT00452400|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol (albuterol))|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Number of puffs||Standard Error|Least Squares Mean
142046|NCT00452400|Secondary|Weekly Mean Evening PEFR After 4 Weeks|Baseline PEFR was defined as the mean of the evening PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
142047|NCT00452400|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|Baseline PEFR was defined as the mean of the morning PEFR measurements obtained during the week just prior to first dose of randomized treatment.|4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter/minute||Standard Error|Least Squares Mean
142048|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142049|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142050|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 1 Week|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142051|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|baseline and day1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142052|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142053|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 1 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142054|NCT00452400|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.Means are adjusted using a mixed effects model with baseline,treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142081|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 52|Value at Week 52 minus value at baseline.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142055|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 2|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 2|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142056|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Week 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at Week 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142057|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours postdose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h relative to dose at day 1|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142058|NCT00452400|Secondary|Peak FVC (0-3h) Response After 4 Weeks|Peak (0-3h) will be the maximum post-dose value during the first 3 hours. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142059|NCT00452400|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FVC AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142060|NCT00452400|Secondary|Peak FEV1 (0-3h) Response After 4 Weeks|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with baseline, treatment and centre (centre random, all other effects fixed).|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to 30 min, 1 h, 2 h, and 3 h relative to dose after 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142061|NCT00452400|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-6 h (AUC 0-6h) Response at Week 4|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and 30 min, 1h, 2h, 3h, 4h, 5h, 6h relative to dose at Week 4|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142062|NCT00452400|Secondary|Trough FVC Response After 4 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142063|NCT00452400|Secondary|Trough FVC Response After 2 Weeks|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142064|NCT00452400|Secondary|Trough FVC Response After 1 Week|Trough FVC was defined as the mean of the two values obtained at 1 hour and 10 minutes prior to the pulmonary function test maneuver. Response is defined as change from the baseline value. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142065|NCT00452400|Secondary|Trough FEV1 Response After 2 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 2 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142066|NCT00452400|Secondary|Trough FEV1 Response After 1 Week|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 1 week|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142067|NCT00452400|Primary|Trough FEV1 Response After 4 Weeks|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.|Baseline and 4 weeks|Full analysis set (FAS) is defined as all randomized patients who received at least one dose of treatment and had baseline data for at least one endpoint.||Liter||Standard Error|Least Squares Mean
142068|NCT00452387|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Overall survival was measured from day 1 of treatment until the end of treatment and then every 3 months thereafter until death.|||Months||95% Confidence Interval|Median
142069|NCT00452387|Secondary|Quality of Life (QoL)|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The scores for the 6 categories are combined and normalized, and used to describe overall quality of life. Because normalized scores are created using a look-up index, there is no clearly defined maximum value. In practice, the maximum value for the combined scale is 73.5.|The Patient Care Monitor questionnaire was administered on day 1 of every cycle (approximately every 3 weeks) during study treatment.|||units on a scale||Full Range|Mean
142070|NCT00452387|Secondary|Correlation of Biochemical Criteria (PSA, Prostate-specific Antigen) With Objective Imaging|The test of association assesses the null hypothesis that the frequency of PSA response is the same for patients with and without a favorable imaging response. PSA response required a 50% reduction of the baseline PSA result that was confirmed three weeks later. Favorable imaging response is defined as stable disease, partial response, or complete response per RECIST guidelines. The Fisher’s exact test was used to test this hypothesis.|PSA was evaluated on day 1 of every cycle (approximately every 3 weeks) during study treatment. Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.|||Participants|||Number
142071|NCT00452387|Primary|Median Time to Progression (TTP) by Imaging|Time to progression is defined as the time from treatment start until objective tumor progression. The median time to progression is the parameter used to describe TTP.|Radiologic imaging was repeated after every 4 cycles (approximately every 12 weeks) during study treatment.|Survival analysis was performed for 22 patients. However, the upper 95% confidence interval for median TTP could not be calculated and so the number of patients analyzed and the upper 95% confidence interval for median TTP could not be entered into the system.||Months||95% Confidence Interval|Median
142072|NCT00452374|Secondary|Number of Participants With a Complete Response or Partial Response|According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days|||Participants|||Number
142073|NCT00452374|Primary|Maximum Tolerated Dose (MTD) Oxaliplatin|MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale.|From treatment onset to end of each cycle of treatment (every 21 days)|Of the 48 study participants, 19 were enrolled in the Phase I MTD group and included in the MTD analysis.||mg/m^2|||Number
142074|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142075|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52||Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142076|NCT00452361|Secondary|Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24||Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142077|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104||Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142078|NCT00452361|Secondary|Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52||Weeks 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142079|NCT00452361|Secondary|Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104||Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142080|NCT00452361|Secondary|Change From Baseline in Systolic Blood Pressure at Week 104|Value at Week 104 minus value at baseline.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142086|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142087|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142088|NCT00452361|Secondary|Patient and Graft Survival|Patient survival defined as participants living with or without a functioning graft. Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142089|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 104|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142090|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 52|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142091|NCT00452361|Secondary|Change in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|Baseline and Week 24|Insufficient or no data available for efficacy analyses because study was terminated early.|||||
142092|NCT00452361|Primary|Change in Glomerular Filtration Rate (GFR) Change From Baseline|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|104 weeks|No patients completed 104 weeks and therefore no data were available for efficacy analysis.|||||
142093|NCT00452348|Secondary|Rate of Asthma Attacks Per Participant Per Year|The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a >=20% decrease in AM PEF, a >=70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.|Week 1 through Week 52|ITT Population||attacks per participant per year||95% Confidence Interval|Mean
142094|NCT00452348|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52|A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population for which at least 1 week of diary data were provided||Percentage of symptom-free days||Standard Error|Mean
142095|NCT00452348|Secondary|Mean Change From Baseline in AM PEF Over Weeks 1-52|Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Participants in the ITT Population who had a minimum of 1 week PEF values||Liters/minute (L/min)||Standard Error|Mean
142096|NCT00452348|Primary|Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52|Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.|Baseline and Week 1 through Week 52|Intent-to-Treat (ITT) Population: all participants randomized to study drug who had at least one on-treatment FEV1||Liters||Standard Error|Mean
142097|NCT00452335|Secondary|Treatment Effectiveness|Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
142098|NCT00452335|Secondary|Constipation Severity|Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
142099|NCT00452335|Secondary|Pain Associated With SBMs|Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
142100|NCT00452335|Secondary|Abdominal Discomfort|Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
142101|NCT00452335|Secondary|Abdominal Bloating|Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
142102|NCT00452335|Secondary|Stool Consistency of SBMs|Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
142103|NCT00452335|Secondary|Straining Associated With SBMs|Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.|Weekly, up to 4 weeks|ITT Population||units on a scale||Standard Deviation|Mean
142104|NCT00452335|Secondary|Frequency of Fecal Incontinence|As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.|Weekly, up to 4 weeks|ITT Population||episodes of fecal incontinence per day||Standard Deviation|Mean
142105|NCT00452335|Secondary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Weeks 2, 3, and 4|ITT Population||spontaneous bowel movements per week||Standard Deviation|Mean
142106|NCT00452335|Primary|Frequency of Spontaneous Bowel Movements|Gathered as part of the daily electronic diary questions.|Week 1|ITT population||spontaneous bowel movements per week||Standard Deviation|Mean
142107|NCT00452114|Secondary|Peak Expiratory Cough Flow||12 months||||||
142108|NCT00452114|Secondary|Pulmonary Function: FEV1||12 months||||||
142109|NCT00452114|Secondary|Quality of Life (St. George's Respiratory Questionnaire, Cough-Specific Quality of Life Questionnaire)||12 months||||||
142110|NCT00452114|Primary|Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits||12 months||||||
142111|NCT00452114|Primary|Number of Suppurative Exacerbations Per Patient Per Year||12 months|interim analysis indicates statistical futility for primary outcomes|||||
142112|NCT00451958|Secondary|Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||International units/Liter (IU/L)||Full Range|Median
142113|NCT00451958|Secondary|Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||International units/Liter (IU/L)||Full Range|Median
142114|NCT00451958|Secondary|Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||ng/mL||Full Range|Median
142115|NCT00451958|Secondary|Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56||From time of switch to Day 56|All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.||ng/mL||Full Range|Median
142116|NCT00451958|Secondary|Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards|"The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study.~In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study."|Until all participants have received at least 5 years of treatment and at a frequency of every 6 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).||percentage||95% Confidence Interval|Number
142117|NCT00451958|Secondary|Percentage of Participants With no Prostate-specific Antigen (PSA) Progression|PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).|Until all participants have received at least 5 years of treatment and at a frequency of every 3 months|CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).||percentage of participants||95% Confidence Interval|Number
142118|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.||participants|||Number
142119|NCT00451958|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.|Up to 4 years of treatment|The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.||participants|||Number
142120|NCT00451906|Secondary|Number of Participants With Central Nervous System Bleeding|The incidence of central nervous system (CNS) bleeding was reported for participants who developed CNS metastases during the study period and who did not have Computed Tomography (CT) or magnetic resonance imaging (MRI) techniques of the head performed at baseline.|Up to 3 years|The ITT population was used for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. n = number of participants available at the time of assessment who were included in the analysis.||participants|||Number
142352|NCT00448630|Secondary|Metabolic Syndrome Parameter Triglycerides by Treatment Group|Iterative measurement of triglycerides. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl||Standard Deviation|Mean
142121|NCT00451906|Secondary|Time to Disease Progression|Time to disease progression was defined as time between first bevacizumab administration and date of first occurrence of progressive disease. Participants who had not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|Up to 3 years|The ITT population was considered for analysis, which included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.||Months||95% Confidence Interval|Median
142122|NCT00451906|Secondary|Duration of Overall Survival|Overall survival time was defined as time between first bevacizumab administration and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment. Participants available at the time of assessment were included in the analysis.||Months||95% Confidence Interval|Median
142123|NCT00451906|Primary|Number of Participants With Serious Adverse Events Related to Bevacizumab|Participants with serious adverse events (SAEs) related to bevacizumab were reported for the duration of the study.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.||participants|||Number
142124|NCT00451906|Primary|Number of Participants With Adverse Events of Special Interest|Participants with adverse events (AEs) of special interest (hypertension, proteinuria, wound healing complications, gastrointestinal perforation, arterial and venous thromboembolic events, hemoptysis, Central Nervous System (CNS) bleeding, other hemorrhage events and congestive heart failure) were reported.|Up to 3 years|The ITT population included all participants with at least one valid post-baseline (Day -28 to -1) assessment.||participants|||Number
142125|NCT00451698|Secondary|Length of Hospitalization||at hospital discharge|||days||Standard Deviation|Mean
142126|NCT00451698|Secondary|Inotropic Support||24 and 48 hours post operative||||||
142127|NCT00451698|Primary|Echocardiographic Assessment of Heart Function||24 hours postop||||||
142128|NCT00451698|Primary|Biochemical Markers of Neuron Damage||4 postoperative time points||||||
142129|NCT00451698|Primary|Biochemical Markers of Heart Damage|Troponin I levels (ng/ml) measured at 4 time points|4 postoperative time points|||ng/ml||Standard Deviation|Mean
142130|NCT00451451|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution|2 years|The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.||Proportion of Participants|||Number
142131|NCT00451451|Secondary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for MS, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Proportion of subjects,confirmed relapse|||Number
142132|NCT00451451|Secondary|Number of New T1 Hypointense Lesions|The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption||Number of lesions||95% Confidence Interval|Mean
142133|NCT00451451|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.|2 years|Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data & were included in the analysis. Missing data before the use of alternative MS medications & visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption.||Number of lesions||95% Confidence Interval|Mean
142147|NCT00451204|Primary|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|24 months|Included all as intention to treat||relapses per year||95% Confidence Interval|Mean
142134|NCT00451451|Primary|Annualized Relapse Rate|"A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.~The adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus>2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment."|2 years|The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Relapses Per Year||95% Confidence Interval|Mean
142135|NCT00451282|Secondary|Health Service Utilization Over the 6 Months Post-injury|Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.|6 months||||||
142136|NCT00451282|Secondary|Adherence With Medical Discharge Instructions|The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers’ contacts with study participants, including whether psychosocial concerns were identified since the injury.|6 months||||||
142137|NCT00451282|Secondary|Health-related Quality of Life 6 Weeks and 6 Months Post-injury|The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.|6 months||||||
142138|NCT00451282|Secondary|Depression Symptoms in Children 6 Mos Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 week follow-up.||Units on a scale||Standard Deviation|Mean
142139|NCT00451282|Secondary|Depression Symptoms in Children 6 Wks Post-injury|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.||Units on a scale||Standard Deviation|Mean
142140|NCT00451282|Primary|PTSD Symptoms in Children 6 Months Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 months|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 month follow-up.||Units on a scale||Standard Deviation|Mean
142141|NCT00451282|Primary|PTSD Symptoms in Children 6 Weeks Post-injury|The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.|6 weeks|85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.||Units on a scale||Standard Deviation|Mean
142142|NCT00451204|Other Pre-specified|Relapse Event, Annualized Relapse Rate|Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.|12 months|||relapses per year||95% Confidence Interval|Mean
142143|NCT00451204|Other Pre-specified|Confirmed Relapse, Annualized Relapse Rate|A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.|12 months|||relapses per year||95% Confidence Interval|Mean
142144|NCT00451204|Secondary|Relapse Event, Probability of First Relapse Event||24 months|Included all as intention to treat||probability of relapse event at 24 mo||95% Confidence Interval|Mean
142148|NCT00451191|Primary|Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.|The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) >=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection.|12 weeks|By the last 12-month follow-up visit, 15 men (22%) in the 100 U dose arm and 11 (17%) in the 300 U dose arm had withdrawn due to dissatisfaction with treatment results or continued to attend study follow-up but received additional alternate treatment prior to 12 months.||participants|||Number
142149|NCT00451048|Secondary|Frequency and Severity of Observed Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)||Up to 6 years||||||
142150|NCT00451048|Secondary|Time to Progression||At 6 months and 1 year||||||
142151|NCT00451048|Secondary|Progression-free Survival||At 6 months and 1 year||||||
142152|NCT00451048|Secondary|Overall Survival||At 6 months and 1 year||||||
142153|NCT00451048|Secondary|Duration of Response||Up to 6 years||||||
142154|NCT00451048|Primary|Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria||Up to 6 years|||percentage of participants|||Number
142155|NCT00450866|Secondary|Overall Survival|Median time (months) that patients survived during the duration of the study.|48 months from start of study|Intention to treat||months||95% Confidence Interval|Median
142156|NCT00450866|Secondary|Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat||participants|||Number
142157|NCT00450866|Secondary|CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria|Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of >50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a > 25% increase in tumor area (two diameters)|3 months after treatment|Intention to treat||participants|||Number
142158|NCT00450866|Secondary|Toxicity as Measured by NCI CTCAE v3.0|Percent of patients that experience the most common grade 3 and above toxicities possibly related to study drug – to be measured using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|3 months after treatment|Intention to treat||percentage of participants|||Number
142159|NCT00450866|Primary|Central Nervous System (CNS) Progression-free Survival(PFS)|"The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.~PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death."|3 months after treatment|Intention to treat||participants|||Number
142160|NCT00450801|Secondary|Number of Patients Experiencing Adverse Events.|Number of patients experiencing adverse events during the course of protocol therapy.|Up to 5 years|||participants|||Number
142161|NCT00450801|Secondary|Response Rate|Percentage of participants achieving complete response (CR) to protocol therapy according to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL) using the CT imaging method. Patients were classified by best tumor response; CR was defined as normalization of the lactate dehydrogenase (LDH), complete disappearance of disease-related symptoms and lymph nodes, and clearance of lymphoma from involved organs; complete response unconfirmed (CRu) as a residual lymph node greater than 1.5 cm in greatest transverse diameter that had regressed by more than 75% or an indeterminate bone marrow examination; partial response (PR) as greater than 50% reduction in the involved lymph nodes, or disappearance of the involved lymph nodes but persistent bone marrow involvement; relapse/progression as new or increased lymph nodes, organomegaly, or reappearance of bone marrow involvement.|Up to 5 years|Participants who completed at least two cycles of therapy.||percentage of participants||95% Confidence Interval|Number
142162|NCT00450801|Secondary|Overall Survival Rate|Percentage of participants who are alive up to five years after receipt of protocol therapy.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
142163|NCT00450801|Primary|Progression-free Survival Rate|Percentage of participants achieving progression-free survival at 1, 3 and 5 years after the start of protocol therapy, based upon the International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL). Progression is defined as a ≥ 50% increase from nadir in the product of the two largest perpendicular diameters (PPD-size) of any previously identified abnormal node, or appearance of any new lesion.|Up to 5 years|||percentage of participants||95% Confidence Interval|Number
142164|NCT00450749|Secondary|Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue||At 4-7 weeks||||||
142165|NCT00450749|Secondary|Histological Characteristics of Prostatic Surgical Tissue||At 4-7 weeks||||||
142166|NCT00450749|Secondary|Expression of GST-pi in Prostatic Surgical Tissue||At 4-7 weeks||||||
142167|NCT00450749|Secondary|Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay||At baseline and at 4-7 weeks||||||
142168|NCT00450749|Secondary|Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3||At baseline and at 4-7 weeks||||||
142169|NCT00450749|Secondary|Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue||At 4-7 weeks||||||
142170|NCT00450749|Secondary|Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2||Baseline and at 4-7 weeks||||||
142171|NCT00450749|Secondary|Ratio of T:DHT in Prostatic Surgical Tissue||At 4-7 weeks||||||
142172|NCT00450749|Secondary|Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum||Baseline and at 4-7 weeks||||||
142173|NCT00450749|Primary|Change in Serum Lycopene Concentration|The differences in the mean of the 6 week (± 1 week) serum lycopene concentrations after adjusting for baseline serum lycopene concentrations calculated between the three arms, together with 95% confidence intervals.|Baseline and at 4-7 weeks||||||
142174|NCT00450749|Primary|Concentration of Lycopene in Prostatic Surgical Tissue|Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.|At 4-7 weeks|Tissue samples collected from five participants for measurement of lycopene levels, representing only 50% (5 of 10) of the participants’ enrolled on-trial.||ug/dL|||Number
142175|NCT00450723|Primary|Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes||5 years|Of the 39 patients enrolled, 34 had identifiable internal mammary sentinel lymph nodes.||participants|||Number
142176|NCT00450723|Primary|Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes||5 years|||participants|||Number
142177|NCT00450723|Primary|Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy||5 years|||participants|||Number
142178|NCT00450658|Secondary|The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.|The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic exam. Subjects were assigned according to the treatment to which they received.||participants|||Number
142179|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|||participants|||Number
142180|NCT00450658|Secondary|Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit were performed.||participants|||Number
142181|NCT00450658|Primary|Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.|The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination.||participants|||Number
142182|NCT00450619|Secondary|Palliation: Improvement in Baseline Pain|Subjective report of participant pain at baseline. This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|post quadramet (samarium)|||participants|||Number
142183|NCT00450619|Secondary|Palliation: Pain at Baseline|Subjective report of participant pain at baseline.This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.|Baseline|||participants|||Number
142184|NCT00450619|Secondary|Objective Response (Complete Response + Partial Response)|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD.|4 weeks|Not all participants was measureable by RECIST.||participants|||Number
142185|NCT00450619|Secondary|Arm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 786, 374, 345, 402, 821, 815, 5269, 453, 633, 1242 & 0 for PT 2 CD4/CD8 IL2 & 0 for PT 16 TNF are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.||Absolute # CD4 or CD8 producing cytokine|||Number
142186|NCT00450619|Secondary|Arm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatment|PSA T-cell responses were measured by fluorescence activated cell sorting (FACS)-based assay for T-cells expressing type I cytokines interferon (IFN-ϓ), interleukin 2 (IL2), tumor necrosis factor alpha (TNF-a) and/or lysosome-associated membrane protein (CD107a).|Approximately 60 days|(a)Cytokine or CD107a in CD4 or CD8. *Pts displayed pre-existing PSA-specific T-cell responses. Numbers 274, 630, and 1427 are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.||Absolute # CD4 or CD8 producing cytokine|||Number
142187|NCT00450619|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|From date of randomization until death or last follow up, whichever comes first, assessed up to 14 months.|||Months||95% Confidence Interval|Median
142188|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥50%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months|||participants|||Number
142189|NCT00450619|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) ≥ 30%|PSA is defined by the PSA Working Group criteria. A minimum PSA decline of at least 50% must be confirmed by a second PSA value 4 or more weeks later.|4 months|||participants|||Number
142192|NCT00450619|Primary|Number of Patients With Stable Disease at 4 Months.|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable disease is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Partial response (PR) is at least a 30% increase in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions on computed tomography (CT) or two or more lesions on bone scan.|4.7 months|||participants|||Number
142193|NCT00450580|Secondary|Study Endpoints for a Subset of Subjects Receiving Study Drug Beyond 48 Weeks|Adaptive two-stage design study up to 48 weeks. N=200, expanding to 728 if continuation criteria were achieved based on a 24-week interim analysis. The initial 200 participants would continue until the last subject of the expanded cohort reached 48 weeks and would constitute the subset. As continuation criteria were not achieved, the study did not proceed to the second stage, and full analysis was performed on the initial 200 participants only.|Up to 60 weeks||||||
142194|NCT00450580|Secondary|Steady-state Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 4, 12, and 24|Blood samples were drawn at Weeks 4, 12, and 24 to determine plasma concentrations (Ctau) of APV and RTV|Weeks 4, 12, and 24|PK parameter (Ctau) Population – Participants in the ITT-E population who underwent PK sampling and had evaluable APV Ctau or RTV Ctau data||micrograms/mL||95% Confidence Interval|Geometric Mean
142195|NCT00450580|Secondary|Number of Protocol-defined Virological Failures With Genotypic and Phenotypic Resistance Changes|A blood sample was drawn at the time of confirmation of virological failure, and mutations present in the virus were identified and compared to those found in the blood sample at baseline. New mutations were tabulated by drug class. RT, reverse transcriptase. Virological failure could occur anytime from Week 4 to Week 48.|Time to virologic failure; Week 4 up to Week 48|Participants in the ITT-E Population who met the definition of virological failure||Participants|||Number
142196|NCT00450580|Secondary|Change From Baseline in Non-HDL Cholesterol at Week 48|Blood samples were drawn to determine the non-HDL cholesterol levels at Week 48. The mean absolute change in non-HDL cholesterol was defined as the Week 48 levels minus levels at baseline.|Week 48|Safety Population: all participants who received at least one dose of study medication||mmol/L (millimoles/Liter)||Standard Deviation|Mean
142197|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline CD4+ Count, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at week 48 was determined (by analysis of blood draw) and categorised by baseline CD4+ count.|Week 48|ITT-E Population||Participants|||Number
142198|NCT00450580|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL (Primary Endpoint) at Week 48 Categorised by Baseline Viral Load, TLOVR Analysis|The number of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined (by analysis of blood draw) and categorised by baseline viral load (BVL).|Week 48|ITT-E Population||Participants|||Number
142199|NCT00450580|Secondary|Percentage of Participants With HIV-1 RNA <50 and >=50 Copies/mL by Visit Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined by the TLOVR algorithm|Week 48|ITT-E Population||Percentage of participants|||Number
142200|NCT00450580|Primary|Percentage of Participants With HIV-1 RNA <400 and >=400 Copies/mL Over 48 Weeks|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at week 48. The percentage of participants with HIV-1 RNA <400 copies/mL at Week 48 was determined by the Time to Loss Of Virologic Response (TLOVR) algorithm.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: All randomised participants who received at least one dose of study medication||Percentage of participants|||Number
142201|NCT00450437|Primary|Percentage of Seroresponders, Ages 19 to 55 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Number
142202|NCT00450437|Secondary|Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years|Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).|Days 1 to 7|The analysis was performed on the safety set.||Participants|||Number
142203|NCT00450437|Secondary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years|Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).|28 days after vaccination|The analysis set was the per protocol (PP) population.||Titers||95% Confidence Interval|Geometric Mean
142204|NCT00450437|Secondary|Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years|"Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analyses set was performed on the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Number
142232|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with UGI (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|||participants|||Number
142205|NCT00450437|Secondary|Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years|"The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The Analysis set was the per protocol (PP) population.||Percentage of Participants||95% Confidence Interval|Number
142206|NCT00450437|Primary|Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years|"Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.~Note: severe adverse events: unable to perform normal daily activity"|6 days after vaccination|The analysis was performed on the safety set.||Participants|||Number
142207|NCT00450437|Primary|Percentage of Seroresponders, Ages 11 to 18 Years|"Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).~Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days after vaccination|The analysis set was the per protocol (PP) population.||Percentage of participants||95% Confidence Interval|Number
142208|NCT00450437|Primary|Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years|The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)|28 days after vaccination|The analysis was performed on the Per Protocol (PP) Population||Titers||95% Confidence Interval|Geometric Mean
142209|NCT00450424|Secondary|Patient Satisfaction With the Preparation to Make a Decision|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU).|at enrollment and 2 weeks after enrollment||||||
142210|NCT00450424|Secondary|Impact of Demographic Factors, Disease/Family History Characteristics, Family Support, and Cancer-related Distress on Satisfaction With and Completeness of the Informed Consent Process|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Impact of demographic factors, disease/family history characteristics, family support, and cancer-related distress on satisfaction with and completeness of the informed consent process was measured|at enrollment and 2 weeks after enrollment||||||
142211|NCT00450424|Secondary|Differential Impact of CD-ROM on Satisfaction With MSI Test Decision, Difficulty Making Decision & Decisional Conflict; Attitude; General & Cancer-related Distress; Discussions With Family About MSI Test & Familial Colorectal Cancer Risk|Participants completed a baseline survey upon enrollment to the trial. 2 weeks after baseline, they completed a follow-up survey (assessed at both baseline and FU). Differential impact of CD-ROM on satisfaction with MSI test decision, difficulty making decision & decisional conflict; attitude; general & cancer-related distress; discussions with family about MSI test & familial colorectal cancer risk were measured.|at enrollment and 2 weeks after enrollment||||||
142212|NCT00450424|Primary|Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing|"10-item true/false MSI knowledge survey developed by the oncologists on trial. (e.g., Microsatellite Instability is found in every person that has had cancer.; Microsatellite Instability may be caused by a permanent change in a gene that is inherited from a person’s mother or father.). Participants can score anywhere from 0 (no questions answered correctly) to 10 (all questions answered correctly)."|2 weeks after enrollment|||units on a scale||Standard Deviation|Mean
142213|NCT00450372|Secondary|Median Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.||months||95% Confidence Interval|Median
142214|NCT00450372|Secondary|Median Overall Survival|Overall survival will be estimated using the product-limit method of Kaplan & Meier.|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.||months||95% Confidence Interval|Median
142215|NCT00450372|Primary|Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.|Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD|Up to 16 months|Of the 38 subjects enrolled, only 10 were ASS-positive and 17 were ASS-negative. The remaining 11 subjects, who declined pre-treatment biopsies, were not assessed.||participants|||Number
142216|NCT00450333|Secondary|Change From Baseline in Hematocrits at 16 and 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and Weeks 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|||||
142249|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
142217|NCT00450333|Secondary|Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|week 16 and 24|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|||||
142218|NCT00450333|Primary|Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|Baseline and 24 weeks|This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.|||||
142219|NCT00450294|Primary|Left Intraocular Pressure|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure|||mm Hg||Standard Error|Least Squares Mean
142220|NCT00450294|Primary|Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.|Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.|Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure|The analysis was per protocol.||mm Hg||Standard Error|Least Squares Mean
142221|NCT00450255|Secondary|Impact of the VEGF Trap Therapy on Laboratory Correlates||Up to 5 years||||||
142222|NCT00450255|Secondary|Toxicities Assessed Using NCI CTCAE v3.0||Up to 5 years||||||
142223|NCT00450255|Secondary|Overall Survival|Will be estimated by the Kaplan-Meier method.|From the initial date of treatment to the recorded date of death, assessed up to 5 years|||Months||95% Confidence Interval|Median
142224|NCT00450255|Primary|4 Month PFS Rate in Comparison With Historical Data|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~The targeted 4-months PFSR was based on three recently reported (at the time of study design) phase III randomized clinical trials with a median of 2.3 months PFS as a conservative external standard. If this regimen's improved median PFS from 2.3 to 4 months, corresponding to an improvement in the 4-month PFSR from 30% to 50% using a constant hazard model, we concluded that it would warrant further study. The study design yields a 85% power to detect a true 4-month PFS rate of at least 50%."|4 months|||percentage of patients||95% Confidence Interval|Number
142225|NCT00450255|Primary|Objective Response Rate (CR + PR)|"Using the RECIST v1.0 criteria for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR.,"|Start of treatment to disease progression/recurrence, up to 5 years|||percentage of participants||95% Confidence Interval|Number
142226|NCT00450242|Secondary|Modified Gracely Pain Scale|The Modified Gracely Pain Scale consists of two components: 1) three numerical scales scored 0-100 for lowest, average, and highest pain level during during the preceding week, and 2) two word choice scales measuring affective and intensity levels. Each word in the word choice scales has an assigned number. Change scores on each subscale can thus be calculated over time (baseline v. week 8).|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.||units on a scale|||Number
142227|NCT00450242|Secondary|SF-12 Quality of Life Scores|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, and age.|baseline, week 8|The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.||units on a scale|||Number
142228|NCT00450242|Primary|Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8|"Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The mean listed for each group is average week 8 score subtracted from the average baseline score."|baseline, week 8|three lidocaine subjects and one control subject failed to complete the study.||units on a scale||Standard Deviation|Mean
142229|NCT00450242|Primary|Number of Participants Who Report the Ability to Have Intercourse|Participants' response upon inquiry.|baseline, week 8|Three lidocaine subjects and one control subject failed to complete the study.||participants|||Number
142230|NCT00450216|Secondary|The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding)|The secondary efficacy endpoint was the number of participants developing a NSAID-associated serious gastrointestinal complication at any time throughout 24 weeks of treatment. A NSAID-associated serious gastrointestinal complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or gastrointestinal bleeding.|24 weeks|||particpants|||Number
142231|NCT00450216|Secondary|Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.|The secondary efficacy endpoint was the number of participants with duodenal ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|||participants|||Number
142250|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
142233|NCT00450216|Primary|Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers|The primary efficacy endpoint was the number of participants with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A participant is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.|24 weeks|All randomized participants who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination. Participants were assigned according to the treatment to which they were randomized; 2:1 randomization, HZT-501:ibuprofen.||participants|||Number
142234|NCT00450112|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Week 9 to Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||milligrams||Standard Deviation|Mean
142235|NCT00450112|Secondary|Improvement From Baseline in Physician Global Evaluations|Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
142236|NCT00450112|Secondary|Improvement From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
142237|NCT00450112|Secondary|Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||Percentage of Participants|||Number
142238|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Total Score)|Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
142239|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Physical Function Subscore)|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
142240|NCT00450112|Secondary|Improvement From Baseline in WOMAC VAS (Stiffness Subscore)|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
142241|NCT00450112|Secondary|Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)|Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.|Baseline and Week 13|ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||millimeters||Standard Deviation|Mean
142242|NCT00450112|Primary|Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200||13 weeks|||participants|||Number
142243|NCT00450073|Secondary|Parathyroid Hormone, Serum C-telopeptide, Osteocalcin||12 weeks||||||
142244|NCT00450073|Primary|25-hydroxyvitamin D|This is a marker of vitamin D status|12 weeks|||ng/mL||Standard Deviation|Mean
142245|NCT00449956|Secondary|Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks|Percent Change from baseline to 8 weeks in Outflow Pressure Reduction Rate assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the FAS.||Percent Change||95% Confidence Interval|Least Squares Mean
142246|NCT00449956|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks|Percent Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 Weeks|Last observed value during the 8-week treatment period was used in the FAS.||Percent Change||95% Confidence Interval|Least Squares Mean
142247|NCT00449956|Primary|Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks|Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)|8 weeks|Last observed value during the 8-week treatment period was used in the Full Analysis Set (FAS).||mmHg||95% Confidence Interval|Least Squares Mean
142248|NCT00449930|Secondary|Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting||Baseline to Week 24|All randomized patients who received at least 1 dose of the double-blind study therapy.||Participants|||Number
142252|NCT00449930|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The per protocol population required that a patient had measurements both at baseline and at Week 24, and did not have any major protocol violations (e.g. drug compliance <85%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.||Percent||95% Confidence Interval|Least Squares Mean
142253|NCT00449865|Primary|The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson’s Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.|All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).|Change from baseline to 5 YEARS|Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis).||summed-ranks||95% Confidence Interval|Mean
142254|NCT00449787|Secondary|Patient Satisfaction|"At the 48 hour assessment, patients were asked, The next time you go to an emergency room with a headache, do you want to receive the same medication. This outcome tabulates the number of affirmative responses."|48 hours after ER discharge|||participants|||Number
142255|NCT00449787|Secondary|Headache-related Functional Disability|This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment.|Baseline, two hours|Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here.||participants|||Number
142256|NCT00449787|Primary|Numerical Rating Scale|"Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable.~Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief"|Baseline, two hours|After discharge from the emergency room, some patients had headache requiring use of medication and some did not. Only those patients who took the investigational medication were included in the analysis||units on a scale||Standard Deviation|Mean
142257|NCT00449748|Primary|Number of Participants With Objective Response|Efficacy reported as objective response. Objective response defined as change in serum tryptase level or bone marrow mast cell percentage.|Monthly for first 3 months, then every 3 months|Analysis was per protocol.||Participants|||Number
142258|NCT00449696|Secondary|Acetaminophen Consumption|Weekly mean acetaminophen consumption between weeks 9 and 13.|Weeks 9 to 13 (5 weeks)|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||milligrams||Standard Deviation|Mean
142259|NCT00449696|Secondary|Change From Baseline in Physician Global Evaluations|Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule.||scores on a scale||Standard Deviation|Mean
142260|NCT00449696|Secondary|Change From Baseline in Subject Global Evaluations|Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
142261|NCT00449696|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore|Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
142262|NCT00449696|Secondary|Change From Baseline in Short Form - 36 (SF-36)|Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores||Standard Deviation|Mean
142263|NCT00449696|Secondary|Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response|Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).|Weeks 6 to 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||Percentage|||Number
142353|NCT00448630|Secondary|Metabolic Syndrome Parameter Waist Circumference by Treatment Group|Iterative measurement of waist circumference. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||cm (centimeter)||Standard Deviation|Mean
142264|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Total Score|Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
142265|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Physical Function Subscore|Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
142266|NCT00449696|Secondary|Change From Baseline in WOMAC VAS Stiffness Subscore|Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.|Baseline and Week 13|ITT population was used for analysis. 2 patients with Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.||scores on a scale||Standard Deviation|Mean
142267|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 2)|The table below shows the percentage of participants in Stage 2 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 24, Week 72, and Week 120 (Stage 2)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Percentage of Participants|||Number
142268|NCT00449644|Secondary|The Percentage of Participants With Sputum Culture Conversion (Stage 1)|The table below shows the percentage of participants in Stage 1 who were responders to treatment. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders.|Week 8, 24, and 104 (Stage 1)|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Percentage of Participants|||Number
142269|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 72 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 72, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
142270|NCT00449644|Secondary|The Time to Sputum Culture Conversion at Week 24 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
142271|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 24 (Stage 2)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 24, Stage 2|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
142272|NCT00449644|Primary|The Time to Sputum Culture Conversion at Week 8 (Stage 1)|The table below shows the time to sputum culture conversion. Sputum culture conversion is defined as as having 2 consecutive negative cultures at least 25 days apart, not followed by a confirmed positive during the considered time period. Participants who discontinue or die during the considered time period are considered as non-responders and censored at their last assessment.|Week 8, Stage 1|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of study drug and did not have extensively drug resistant tuberculosis (XDR-TB) or non-multi-drug resistant tuberculosis (non-MDR-TB) at the start of the trial and were evaluable for efficacy.||Days||95% Confidence Interval|Median
142354|NCT00448630|Secondary|Metabolic Syndrome Parameter Weight by Treatment Group|Iterative measurement of weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg||Standard Deviation|Mean
142273|NCT00449540|Secondary|Percentage of Participants Who Have Photophobia|Percentage of participants who have symptoms of photophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment|||Percentage of participants|||Number
142274|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms Phonophobia|Percentage of participants who have symptoms of phonophobia two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|2 hours post treatment|||Percentage of Participants|||Number
142275|NCT00449540|Secondary|Percentage of Participants Who Have Symptoms of Nausea|Percentage of participants who have symptoms of nausea two hours post treatment. For each treated aura episode, the subjects rated the severity of photophobia, nausea, and phonophobia as none, mild, moderate, or severe at baseline and recorded the presence or absence of vomiting at baseline (before application of the device) at 30 minutes, and at 1, 2, 24 and 48 hours posttreatment.|two hours post treatment|||percentage of participants|||Number
142276|NCT00449540|Primary|Percentage of Participants Experiencing no Pain at Two Hours Post-treatment|Number of participants experiencing no pain at two hours post-treatment divided by total number of participants treated. For each treated aura episode during the migraine treatment phase, the subjects rated the pain intensity of their headache as none, mild, moderate or severe at baseline (before application of the study device) at 30 minutes, and at 1, 2, 24, and 48 hours posttreatement.|Two hours|Full-analysis set: intention to treat population (201) adjusted for those participants who did not administer treatment during the study period||percentage of participants|||Number
142277|NCT00449176|Secondary|Responder Analysis 50% Improvement|"Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|Intent to Treat Analysis Set||Percentage of participants|||Number
142278|NCT00449176|Secondary|Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline and 12 week endpoint|Intent to Treat Analysis Set, LOCF imputation method. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||scores on a scale||Standard Deviation|Mean
142279|NCT00449176|Secondary|Number of Participants With Treatment Discontinuation Due to Lack of Efficacy|The number of participants who discontinued due to lack of efficacy from baseline to endpoint|Baseline and 12 weeks|Intent to Treat Analysis Set||participants|||Number
142280|NCT00449176|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved)|Baseline and 12 week endpoint|Intent to Treat Analysis (ITT) set, Last Observation Carried Forward (LOCF) imputation method. The ITT analysis set included all randomized subjects who took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||percentage of participants|||Number
142281|NCT00449176|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|Intent to Treat population with LOCF imputation. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||hours||Standard Deviation|Mean
142282|NCT00449176|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.|"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline."|Baseline and 12 week endpoint|Intent to Treat (ITT) analysis set, last observation carried forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. The patients who didi not have any assessment during the treatment period were excluded from the analysis.||scores on a scale||Standard Deviation|Mean
142283|NCT00449176|Primary|Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks|Intent To Treat (ITT) analysis set utilizing Last Observation Carried Forward (LOCF) imputation. The ITT analysis set included all randomized patients that took at least one dose of study medication following randomization. 7 patients (3 tapentadol ER, 3 oxycodone CR, 1 placebo) had no baseline pain scores therefore excluded from the analysis.||scores on a scale||Standard Deviation|Mean
142284|NCT00449163|Secondary|Toxicity||2 years||||||
142285|NCT00449163|Secondary|Median Progression-free Survival in Months|Median number of months subjects achieved progression-free survival|2 years|||months||95% Confidence Interval|Median
142286|NCT00449163|Secondary|Response Rate (Complete Response and Partial Response)|Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0|2 years|||percentage of participants||95% Confidence Interval|Number
142287|NCT00449163|Primary|Overall Survival up to 2 Years|Percentage of patients with overall survival times of up to 2 years|2 years|||percentage of participants||95% Confidence Interval|Number
142289|NCT00449150|Primary|International Prostate Symptoms Score (IPSS)|IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)|Baseline and 52 weeks|The ITT population included all participants for whom at least one post-baseline efficacy assessment was available; imputation per Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
142290|NCT00449072|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|"Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs.~A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life-threatening~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was a medically important event"|From Day 1 to 7 days following end of treatment (Day 360)|All randomized and treated participants, excluding those from GCP noncompliant sites.||participants|||Number
142291|NCT00449072|Secondary|24 Hour Cortisol/Creatinine Ratio|Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. No normal range is available for cortisol/creatinine ratio.|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.||μg/g Creatinine||Standard Deviation|Mean
142292|NCT00449072|Secondary|24 Hour Urinary Free Cortisol Levels|Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours].|Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)|All randomized and treated participants, excluding those from GCP noncompliant sites.||μg/24 hours||Standard Deviation|Mean
142293|NCT00449072|Secondary|Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.~The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study."|double-blind treatment period (Day 1 to Day 360)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||percentage of days||Standard Deviation|Mean
142294|NCT00449072|Secondary|Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study|"Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.~The percentage of participants who used the rescue medication during each of the study periods is reported."|Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420)|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||percentage of participants|||Number
142295|NCT00449072|Secondary|Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the investigator using the following scale:~0 = no relief (symptoms unchanged or worse than before)~1 = slight relief (symptoms were present and only minimally improved)~2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)~3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)~4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||score on a scale||Standard Deviation|Mean
142296|NCT00449072|Secondary|Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period|"Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:~0 = no relief (symptoms unchanged or worse than before)~1 = slight relief (symptoms were present and only minimally improved)~2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)~3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)~4 = complete relief (virtually no symptom present)"|Day 120, Day 240 and Day 360|mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites.||score on a scale||Standard Deviation|Mean
142297|NCT00449072|Secondary|Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:~0 = symptom absent~1 = mild (present but not annoying to self)~2 = moderate (annoying to self but not interfering with sleep or daily living)~3 = severe (interfered with daily living and/or sleep)~Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with available nasal symptom scores: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with available nasal symptom scores, excluding those from GCP noncompliant sites.||score on a scale||Standard Error|Least Squares Mean
142309|NCT00449033|Secondary|Euro Quality of Life - 5D (EQ-5D) Index Scores in the ITT (Non-squamous) Population|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 to 1 when the United Kingdom (UK) weights are applied (0=death, 1=perfect health). Higher index scores represent better health states.|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
142298|NCT00449072|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS)|"PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:~0 = symptom absent~1 = mild (present but not annoying to self)~2 = moderate (annoying to self but not interfering with sleep or daily living)~3 = severe (interfered with daily living and/or sleep)~TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms."|For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)|mITT population with scores available for TNSS: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with scores available for TNSS, excluding those from GCP noncompliant sites.||score on a scale||Standard Error|Least Squares Mean
142299|NCT00449072|Primary|Growth Velocity|"Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time.~Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing."|Day 1 to end of treatment (Day 360)|The modified intent-to-treat (mITT) population included all intent-to-treat participants who had at least 3 postrandomization visits with recorded height measurements during the double-blind treatment period, excluding those from Good Clinical Practice (GCP) noncompliant sites.||cm/year||Standard Error|Least Squares Mean
142300|NCT00449046|Secondary|Number of Participants With Rescue Medication-Free Nights and Days|Rescue free means without the use of other medication.|Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Participants|||Number
142301|NCT00449046|Secondary|Number of Participants With Symptom-Free Nights and Days||Baseline and Week 24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Participants|||Number
142302|NCT00449046|Secondary|Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24|"Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Percent Change||Standard Deviation|Mean
142303|NCT00449046|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24|"The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||L/min||Standard Deviation|Mean
142304|NCT00449046|Secondary|Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24|Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||Percent Change||Standard Deviation|Mean
142305|NCT00449046|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24|"PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 is 147 L/min, whose height is 66 is 454 L/min."|Baseline and during Weeks 1-24|Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.||L/min||Standard Deviation|Mean
142306|NCT00449046|Primary|Serious Adverse Events (SAEs) - On Therapy|"Number of participants considered by the investigator to be related to study medication.~Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)"|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication.||Participants|||Number
142307|NCT00449046|Primary|Most Frequent Adverse Events - On Therapy|Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.|Baseline to Week 24|Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication||Participants|||Number
142308|NCT00449033|Secondary|EQ-5D Visual Analog Scale (VAS) Scores in the ITT (Non-squamous) Population|The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|from randomization of the first patient until 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
142310|NCT00449033|Secondary|Time to Symptomatic Deterioration (TSD) in the ITT (Non-squamous) Population|TSD is defined as the time from randomization to the date of symptomatic deterioration (≥3 point decline in the LCS score that is maintained for at least 2 consecutive cycles) or death if death occurs before these 2 consecutive cycles are completed.|from randomization of the first patient to 38 months later or death whatever occurs first|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||months||95% Confidence Interval|Median
142311|NCT00449033|Secondary|Lung Cancer Subscale (LCS) Scores in the ITT (Non-squamous) Population|LCS is a subscale of FACT-L measuring lung cancer specific symptoms. The LCS scores range from 0 to 28, higher scores represent fewer lung cancer symptoms.|from randomization of the first patient to 38 months later or death whatever occurs first.|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
142312|NCT00449033|Secondary|Functional Assessment of Cancer Treatment-Lung (FACT-L) Scores in the ITT (Non-squamous) Population|The FACT-L measures health related quality of life (HRQOL) and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better HRQOL.|from randomization of the first patient until 38 months|All patients valid for the ITT analysis who have a baseline and at least one post baseline value.||scores on a scale||95% Confidence Interval|Least Squares Mean
142313|NCT00449033|Secondary|Time to Response (TTR) in the ITT (Non-squamous) Population|TTR for patients who achieved a best response (CR or PR) was defined as the time from date of randomization to the earliest date that response was first documented.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of TTR based on ITT (non-squamous) population. No statistical testing performed.||days||95% Confidence Interval|Median
142314|NCT00449033|Secondary|Duration of Stable Disease (SD) in the ITT (Non-squamous) Population|Duration of SD was defined as the time from date of randomization to date that disease progression (radiological or clinical, whichever was earlier) was first documented. Patients without disease progression at the time of analysis or death before progression were censored at the date of their last tumor assessment.(Disease progression: increase in the sum of tumor lesion sizes or new lesions.) Duration of stable disease was only evaluated in patients failing to achieve a best response of CR or PR.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of stable disease based on ITT (non-squamous) population. No statistical testing performed.||days||95% Confidence Interval|Median
142315|NCT00449033|Secondary|Duration of Response in the ITT (Non-squamous) Population|Duration of response was defined as the time from date of first documented objective response of PR or CR, whichever was noted earlier, to date of disease progression or death (if death occurred before progression was documented). Patients without disease progression at the time of analysis or death before progression were censored at the last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of duration of response based on ITT (non-squamous) population. No statistical testing performed.||days||95% Confidence Interval|Median
142316|NCT00449033|Secondary|Disease Control (DC) in the ITT (Non-squamous) Population|DC was defined as the total number of patients whose best response was not PD according to RECIST (version 1.0) by Investigator-assessment (= total number of CR + total number of PR + total number of SD; CR or PR had to be maintained for at least 28 days from the first demonstration of that rating, SD had to be documented at least once more than 6 weeks from baseline). PD: an increase in the sum of tumor lesions sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Disease Control based on ITT (non-squamous) population.||percentage of participants|||Number
142317|NCT00449033|Secondary|Percentage of Participants With Different Tumor Response in the ITT (Non-squamous) Population|Tumor response (= Best Overall Response) of a patient was defined as the best tumor response (confirmed Complete Response (CR: disappearance of tumor lesions), confirmed Partial Response (PR: a decrease of at least 30% in the sum of tumor lesion sizes), Stable Disease (SD: steady state of disease), or Progressive Disease (PD: an increase in the sum of tumor lesions sizes or new lesions)) observed during trial period assessed according to the RECIST criteria (version 1.0) based on Investigator-assessment.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of Tumour Response based on ITT (non-squamous) population.||percentage of participants|||Number
142318|NCT00449033|Secondary|Time to Progression (TTP) in the ITT (Non-squamous) Population|TTP was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using RECIST version 1.0). Patients without progression at the time of analysis or death before progression were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of TTP based on ITT (non-squamous) population. TTP for patients with no tumour assessments after baseline was censored at one day.||days||95% Confidence Interval|Median
142319|NCT00449033|Secondary|Progression-free Survival (PFS) in the ITT (Non-squamous) Population|PFS was defined as the time from date of randomization to disease progression (radiological or clinical, whichever was earlier, based on Investigator-assessment using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0) or death due to any cause, whichever occured first. Patients without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression: increase in the sum of tumor lesion sizes or new lesions.|from randomization of the first patient until 38 months or date of death or progression whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks|Evaluation of PFS based on ITT (non-squamous) population. PFS for patients with no tumour assessments after baseline was censored at one day.||days||95% Confidence Interval|Median
142333|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142320|NCT00449033|Secondary|OS in the ITT (Squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used. No statistical testing performed.||days||95% Confidence Interval|Median
142321|NCT00449033|Secondary|OS in the ITT (Both Squamous and Non-squamous) Population|OS was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (both non-squamous and squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.||days||95% Confidence Interval|Median
142322|NCT00449033|Primary|Overall Survival (OS) in the ITT (Non-squamous) Population|Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Patients still alive at the time of analysis were censored at their last date of last contact.|from randomization of the first patient until 38 months or date of death of any cause whichever came first|Evaluation of OS based on ITT (non-squamous) population. Patients alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, where day was missing, day 15 (the middle of the month) was used.||days||95% Confidence Interval|Median
142323|NCT00448916|Secondary|Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142324|NCT00448916|Secondary|Seizure Frequency.|Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE.|28 Days|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142325|NCT00448916|Secondary|Number of Participants With Abnormalities in Creatine Kinase.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142326|NCT00448916|Secondary|Number of Participants With Abnormalities in Endocrine Panel (Hormones).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142327|NCT00448916|Secondary|Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142328|NCT00448916|Secondary|Number of Participants With Hematotolgical Abnormalities.|Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142329|NCT00448916|Secondary|Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).|"Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated.~Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below."|Week 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142330|NCT00448916|Secondary|Height at Month 12/Early Termination.|Height was recorded in centimeters.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included.||cm||Standard Deviation|Mean
142331|NCT00448916|Secondary|Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.|Weight was recorded in kilograms and weight change from Baseline was reported.|Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.||Kg||Standard Deviation|Mean
142332|NCT00448916|Secondary|Derived Body Mass Index Data (BMI) at Month 12/Early Termination.|BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.|Month 12/Early Termination|Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively.||Kg/m^2||Standard Deviation|Mean
142334|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142335|NCT00448916|Secondary|Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).|Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below.|Visit 1 to 12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142336|NCT00448916|Secondary|Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined.|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142337|NCT00448916|Secondary|Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|"Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as abnormal and no abnormalities in the sites were reported as normal. Any change from the previous physical examination results were noted."|Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142338|NCT00448916|Primary|Number of Participants With Adverse Events (AE).|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.|12 Months|Safety analysis set: All participants who received at least one dose of study medication were included.||Participants|||Number
142339|NCT00448864|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve|Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg*h/L)|1, 2, 4, and 8 hours after end of study drug infusion|All participants who received at least 1 dose of study drug.||mg*h/L||Standard Deviation|Mean
142340|NCT00448864|Secondary|Number of Participants With Treatment-emergent Adverse Events|A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|up to 28 days post admission to ICU|All participants who received at least 1 dose of study drug.||participants|||Number
142341|NCT00448864|Secondary|Cumulative Chest Tube Drainage at 24 Hours Postoperatively|Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 24 hours post admission to ICU|All participants who received at least 1 dose of study drug.||Milliliters||Standard Deviation|Mean
142342|NCT00448864|Primary|Cumulative Chest Tube Drainage During the First 12 Hours Postoperatively|Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.|Up to 12 hours post admission to intensive care unit (ICU)|All participants who received at least 1 dose of study drug.||Milliliters||Standard Deviation|Mean
142343|NCT00448760|Secondary|Overall Survival||24 months|||months||95% Confidence Interval|Median
142344|NCT00448760|Secondary|Median Progression-free Survival (PFS)||24 months|||months||95% Confidence Interval|Median
142345|NCT00448760|Secondary|Clinical Response|"Overall response = Complete response (CR) + Partial Response (PR). Evaluated via endoscopic ultrasounds, PET and CT scans of the chest:~Complete Response (CR) applies to participants complete disappearance of all measurable and evaluable disease. No new lesion. No disease related symptoms. No evidence of non-evaluable disease, including tumor markers and other laboratory values.~Partial Response (PR) applies to participants with at least 50 percent reduction in the sum of the products of bi-dimensional perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions."|8 - 16 weeks|||percentage of participants||90% Confidence Interval|Number
142346|NCT00448760|Primary|Pathologic Complete Response|No evidence of cellular residual cancerous cells as evidenced by tumor tissue samples taken via surgery at the end of neo-adjuvant chemotherapy.|8 - 16 weeks|||percentage of participants||90% Confidence Interval|Number
142347|NCT00448708|Secondary|Adverse Events|adverse events with at least 5% incidence, reported as number of subjects experiencing the event (rather than total number of events). Adverse events were collected via subject querying at each visit and telephone contact, and by medical record review.|1 year|||participants|||Number
142348|NCT00448708|Primary|Time-to-loss of Target Site Primary Patency|"Subjects had primary patency at the target site from graft placement until an intervention on the target site occurred. The duration between graft implantation and graft abandonment due to loss of patency at the target site was the time-to-loss of primary patency. Note: The study was halted early and therefore became underpowered to analyze efficacy as detailed in the protocol."|1 year|||days||95% Confidence Interval|Median
142349|NCT00448682|Secondary|Number of Participants Experiencing Adverse Events|Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.|1 year|The study data has not been analyzed.|||||
142359|NCT00448630|Primary|Metabolic Syndrome Parameter Fasting Blood Sugar|Iterative measurement of fasting blood sugar. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||mg/dl (miligrams per deciliter)||Standard Deviation|Mean
142360|NCT00448630|Primary|Metabolic Syndrome Parameter Waist Circumference|Iterative measurement of waist circumference. Mean at timepoints.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||cm (centimeter)||Standard Deviation|Mean
142361|NCT00448630|Primary|Metabolic Syndrome Parameter Body Weight|Iterative measurement of body weight. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg (kilogram)||Standard Deviation|Mean
142362|NCT00448630|Secondary|Metabolic Syndrome Parameter BMI by Treatment Group|Iterative measurement of BMI. Mean at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg/m*m||Standard Deviation|Mean
142363|NCT00448630|Primary|Metabolic Syndrome Parameter Body Mass Index (BMI)|Iterative mean Body Mass Index at time points.|Baseline, 1 Month, 4 Months|Population : Full Analysis Set. Number of participants analyzed includes subjects with data for each visit.||kg/m*m (kilograms per meter squared)||Standard Deviation|Mean
142364|NCT00448591|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)|Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion|Safety Population||percentage of participants|||Number
142365|NCT00448591|Secondary|Percentage of Participants by Best Overall Response to Treatment|Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||percentage of participants|||Number
142366|NCT00448591|Secondary|Overall Survival|Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.|Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months|ITT Population||months||Full Range|Median
142367|NCT00448591|Secondary|Percentage of Participants With Recorded Death||Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||percentage of participants|||Number
142368|NCT00448591|Secondary|Time to Progression (TTP)|TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||months||Full Range|Median
142369|NCT00448591|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months|ITT Population||percentage of participants|||Number
142370|NCT00448539|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase|"Seizure data was collected via patient diaries. OL refers to open-label."|Baseline, Titration Phase (Days 1 to 18), Maintenance Phase|Intent-to-treat (ITT) population: All subjects who completed titration to open-label medication||Percentage change||Full Range|Median
142371|NCT00448448|Secondary|Psychosocial Measures||Measured every 6 months||||||
142372|NCT00448448|Secondary|Radiographic Measures||Measured every 6 months||||||
142373|NCT00448448|Secondary|Clinical Measures||Measured every 6 months||||||
142374|NCT00448448|Primary|Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome)||Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.|The primary analysis included all patients who had completed the trial by January 2013, including 116 patients from the randomized arm and 126 from the preference arm.||percentage of patient successes|||Number
142375|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of participants|||Number
142376|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment|Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of participants|||Number
142377|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of circadian variation||Standard Deviation|Mean
142410|NCT00448175|Primary|Frequency of Voids at 12 Weeks|To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.|Baseline to 12 weeks|||Voids/day||Standard Deviation|Mean
142378|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.||L/Min||Standard Deviation|Mean
142379|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of personal best value||Standard Deviation|Mean
142380|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).|Extension Period weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||Percentage of predicted value||Standard Deviation|Mean
142381|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period|Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).|Extension Period Weeks 11-30|FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.||L/min||Standard Deviation|Mean
142382|NCT00448435|Secondary|Percentage of Subjects With Rescue Medication-Free Nights and Days|Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment|Crossover Period Weeks 1-4, 7-10|PPS||Percentage of participants|||Number
142383|NCT00448435|Secondary|Percentage of Subjects With Symptom-Free Nights & Days|Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment|Crossover Period Week 1-4, 7-10|PPS||Percent of participants|||Number
142384|NCT00448435|Secondary|Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS||Percentage of circadian variation||Standard Error|Mean
142385|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS||L/min||Standard Error|Mean
142386|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period weeks 1-4, 7-10|PPS||Percentage of personal best value||Standard Error|Mean
142387|NCT00448435|Secondary|Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.|Crossover Period Weeks 1-4, 7-10|PPS||Percentage of predicted value||Standard Error|Mean
142388|NCT00448435|Primary|Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods|Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).|Crossover Period Weeks 1-4, and 7-10|PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.||Liters/minute||Standard Error|Mean
142389|NCT00448344|Secondary|The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up|self-reported 7- day point prevalent abstinence|12-months follow-up|||percentage of participants that quit|||Number
142390|NCT00448344|Primary|The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention|self-reported 7-day point prevalent abstinence|5 months|||percentage of participants that quit|||Number
142391|NCT00448279|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population||percentage of participants||95% Confidence Interval|Number
142420|NCT00448136|Secondary|Duration of OR - Percentage of Participants With Sustained Response at 12 and 24 Months|Duration of OR was determined only for those participants with an overall response of CR or PR and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
142392|NCT00448279|Secondary|Percentage of Participants by Best Overall Response (BOR)|BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|BL and every 8 weeks thereafter|ITT population||percentage of participants|||Number
142393|NCT00448279|Secondary|Overall Survival - Time to Event|The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population||months||95% Confidence Interval|Median
142394|NCT00448279|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.|BL and every 8 weeks thereafter|ITT population||percentage of participants|||Number
142395|NCT00448279|Primary|Progression-Free Survival - Time to Event|The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.|BL and every 8 weeks thereafter|ITT population||months||95% Confidence Interval|Median
142396|NCT00448279|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.|Baseline (BL) and every 8 weeks thereafter|ITT population||percentage of participants|||Number
142397|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel|"Assessed by the study personnel using a 5-point scale after dosing:~Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation~Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose~Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose~Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose~Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.||Participants|||Number
142398|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-6h)|Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||(μg/mL)•h||Standard Deviation|Mean
142399|NCT00448227|Primary|Pharmacokinetics of Single Dose - AUC(0-tlast)|Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||(μg/mL)•h||Standard Deviation|Mean
142400|NCT00448227|Primary|Pharmacokinetics of Single Dose - Cmax|Measured by Cmax - The maximum plasma concentration of study medication|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||μg/mL||Standard Deviation|Mean
142401|NCT00448227|Secondary|Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver|"Assessed by the caregiver using a 5-point scale immediately after dosing:~Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation~Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose~Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose~Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose~Very well accepted: infant appeared eager and ingested most of dose without special coaxing"|Immediately after dosing|Safety population.||Participants|||Number
142402|NCT00448227|Secondary|Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.|"Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:~Significant emesis occurred,~Infant spit out most of the dose ingesting less than half of what was administered,~Infant spit out some of the dose, but ingested at least 50% of what was administered,~Infant was able to ingest and retain the dose administered"|30 minutes after dosing|Safety population.||Participants|||Number
142403|NCT00448227|Secondary|Safety Assessed by Labs|Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.|2 days||||||
142404|NCT00448227|Secondary|Safety Assessed by AEs, SAEs|AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.|38 days||||||
142405|NCT00448227|Primary|Pharmacokinetics of Single Dose - Tmax|Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.|Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.|Analysis population included the intent-to-treat population, with the exception of one patient in the 1 to <3 months age group who did not have PK samples taken due to emesis reported after study medication administration.||hours||Full Range|Median
142406|NCT00448175|Secondary|Known Side Effects Through 12 Weeks||12 weeks||||||
142407|NCT00448175|Secondary|OAB Quality of Life at 12 Weeks||12 weeks||||||
142408|NCT00448175|Secondary|Volume Voided at 12 Weeks||12 weeks||||||
142409|NCT00448175|Secondary|Urge Incontinence Episodes at 12 Weeks||12 weeks||||||
142411|NCT00448136|Secondary|EORTC QLQ-C30 Functional and Symptom Scale Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scale scores a higher level represents a more severe level of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
142412|NCT00448136|Secondary|Percentage of Participants With Change From Baseline in Global Health Status by EORTC QLQ-C30 Improvement Category|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Changes from baseline were categorized as follows: Very much worsening (less than [<]-20); Moderate worsening (greater than or equal to [≥]-20 to <-10); Little worsening (≥-10 to <-5); No change (≥-5 to less than or equal to [≤]5); Little improvement (>5 to ≤10); Moderate improvement (>10 to ≤20); and Very much improved (>20).|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
142413|NCT00448136|Secondary|Global Health Status as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Screening, every 3 months during treatment|ITT population; only participants who completed the questionnaire at baseline and who had at least 1 post-baseline assessment were included in the analysis. Number (n) equals (=) the number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
142414|NCT00448136|Secondary|OS - Percentage of Participants Surviving at 12 and 24 Months|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population.||percentage of participants|||Number
142415|NCT00448136|Secondary|OS - Time to Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit. Median OS was estimated using the Kaplan-Meier method.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population||months||95% Confidence Interval|Median
142416|NCT00448136|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the first treatment administration to death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation. Data for participants who were alive at the end of the study were censored at the date of last visit.|Screening, Day 1 of every cycle during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
142417|NCT00448136|Secondary|Duration of ODC - Percentage of Participants Maintaining Disease Control at 12 and 24 Months|Duration of ODC was determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR, or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.||percentage of participants|||Number
142418|NCT00448136|Secondary|Duration of ODC - Time to Event|Determined only for those participants with overall control disease (CR, PR, or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median time to event was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response (CR, PR, or SD) were included in the analysis.||months||95% Confidence Interval|Median
142419|NCT00448136|Secondary|Duration of Overall Disease Control (ODC) - Percentage of Participants With an Event|Determined only for those participants with overall disease control (CR, PR or SD per RECIST) and was defined as the time interval between the first occurrence of disease control (CR, PR or SD) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
150891|NCT00380250|Secondary|Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 3|ITT with LOCF||SBM/week||Standard Deviation|Mean
142421|NCT00448136|Secondary|Duration of OR - Time to Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression. Median duration of OR was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
142422|NCT00448136|Primary|PFS - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
142423|NCT00448136|Primary|PFS - Time to Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to RECIST using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression. Median PFS was estimated using the Kaplan-Meier method.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||months||95% Confidence Interval|Median
142424|NCT00448136|Secondary|Duration of Overall Response (OR) - Percentage of Participants With an Event|Determined only for those participants with an overall response (CR or PR) and was defined as the time interval between the response (CR or PR) and the date of progression or death from any cause. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of progression or death were censored at the data of last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population; only participants with a response of CR or PR were included in the analysis.||percentage of participants|||Number
142425|NCT00448136|Secondary|Percentage of Participants With a Response by Best Overall Response|Best overall response defined as best response recorded during the study as defined according to RECIST; performed by the investigator and by centralized review. Complete response (CR): complete disappearance of all target lesions and non-target disease. All lesions, both target and non-target, must have decreased to normal (short axis, less than [<]10 millimeters [mm]). No new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter (LD) was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD): not qualifying for CR, PR, or Progressive Disease (PD). PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population. Data were missing from centralized review for 1 participant.||percentage of participants||95% Confidence Interval|Number
142426|NCT00448136|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS is defined as the interval between the date of start of treatment and the date of evaluation by the investigator of progressive disease or death from any cause. The progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) using medical imaging during the treatment period and by the investigators (confirmed by medical imaging) during the follow-up period. Data for participants who were lost to follow-up were censored at the date of last evaluation without progression. Data for participants who completed the study without an event of disease progression or death were censored at the date of the last visit or follow-up without progression.|Screening, every 3 months during treatment, every 6 months during follow-up to 2 years|ITT population||percentage of participants|||Number
142427|NCT00448123|Secondary|High Pain Score by Treatment Group|Severity of Patient Pain at 7 days Post Emergency Department Visit. Patients were asked to describe their pain severity at each followup phone call, using a numerical scale, ranging from 0 (no pain) to 10 (worst possible pain). We report this measure at 7 days.|7 Days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided information at the Day 7 interview.||units on a scale||Full Range|Mean
142428|NCT00448123|Secondary|Amount (Mean Number of Tablets Taken) of Pain Medication Taken by Subjects up to Seven (7) Days Post Emergency Department Discharge||1-7 days|The data table is limited to the information collected at Day 7. Of the 53 subjects in the placebo group only 29 provided information regarding pain medication at the Day 7 interview. For the Tamsulosin group, only 15 out of 47 provided the pain medication information at the Day 7 interview. At Day 7 each group had only 3 non-zero responses.||Pain tablets||Full Range|Mean
142429|NCT00448123|Primary|Stone Passage|Participants were asked during the follow-up phone call to indicate if their stone had passed within seven days. Phone calls were conducted at days 1, 2, 3, 7, 10 and 30 days after the emergency department discharge. Data is reported based on the information obtained up to the 7th day.|1-7 days|In the placebo group, of the 47 subjects 18 (46.2%) passed their stone by Day 7. In the Tamsulosin group, of the 53 subjects 21 (53.9%) passed their stone by Day 7.||participants|||Number
142548|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||ng/mL||Standard Deviation|Mean
142430|NCT00448019|Secondary|Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL|ORR defined as CR and PR response where response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.||percentage of participants|||Number
142431|NCT00448019|Secondary|Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)|Response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).|Response assessed after three 4-week courses and after six courses, up to 24 weeks|Five participants of the 62 treated participants were not evaluable for response.||participants|||Number
142432|NCT00448019|Primary|Progression Free Survival (PFS) Rate|Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Baseline up to 5 years|Five participants of the 62 treated participants were not evaluable for response.||Months||Full Range|Median
142433|NCT00447902|Primary|The Primary Safety Endpoint Was the Occurrence of Dose-limiting Hepatotoxicity During the Study.|Dose-limiting hepatotoxicity was defined as Grade 4 ALT or AST elevation confirmed in 48h or any evocative symptoms or signs of hepatitis, if it not clearly attributable to another cause. Patients who experienced dose-limiting hepatotoxicity stopped TPV/r and were considered treatment failures for the analysis.|From the start of the study through 48 weeks.||||||
142434|NCT00447902|Secondary|Frequency of Patients (%) With Possible Clinically Significant Abnormalities of Laboratory Measurements|Frequency of patients (%) with possible clinically significant abnormalities of laboratory measurements (haematology, differentials (automatic and absolute), coagulation, electrolytes, enzymes, substrates, urinalysis, serology and T-cells)|Baseline through 48 weeks|||percentage of participants|||Number
142435|NCT00447902|Secondary|Post-dose Tipranavir (TPV) and Ritonavir (RTV) Concentrations at Week 4|Post-dose Tipranavir (TPV) and Ritonavir (RTV) plasma concentrations at Week 4|Week 4|The trial has been stopped due to a poor enrollment|||||
142436|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Trough Concentration >120 μM|Patients with TPV trough above 120 μM are at high risk of developing a Grade 3 or 4 ALT or AST elevations. The risk of Grade 3 or greater transaminase elevations appeared to be uniform at TPV trough concentration below 120 μM. Hence, for this study the TPV trough should be maintained below 120 μM.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment|||||
142437|NCT00447902|Secondary|Occurrence of Tipranavir (TPV) Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured|A high inhibitory quotient (IQ), the ratio of trough plasma drug concentration to the protein-adjusted viral IC50, is a useful indicator of the potential efficacy margin of antiretroviral drugs. The IQ for TPV is calculated by the formula IQ = TPV Ctrough / (3.75 x Z x fold change of the patients virus), where Z = wild type control IC50 IIIB.|After 2 weeks of treatment until the end of trial|The trial has been stopped due to a poor enrollment|||||
142438|NCT00447902|Secondary|Patients Adherence With Study Medication Based on Pill Count|number of pills actually taken divided by the planned number of pills the patient should take|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
142439|NCT00447902|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|Tipranavir (TPV) and Ritonavir (RTV) trough concentrations from plasma samples at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
142440|NCT00447902|Secondary|Change in Ratio of CD3+ CD8+ CD38+ HLA DR From Baseline to Week 48.|Change from baseline to Week 48 for the ratio of CD3+ CD8+ CD38+ HLA DR . Samples were obtained for CD3+ CD8+ CD38+ HLA DR as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
142441|NCT00447902|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48|Change from baseline to Week 48 for the ratio of CD38+ to CD8+ cell counts. Samples were obtained for CD38+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
142442|NCT00447902|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline to Week 48|Change from baseline to Week 48 for CD4+ and CD8+ cell counts. Samples were obtained for CD4+ and CD8+ as measurements of viral suppression during antiretroviral therapy.|after 2 weeks of treatment till Week 48|The trial has been stopped due to a poor enrollment|||||
142443|NCT00447902|Secondary|Time to New AIDS or AIDS Related Progression Event or Death|Time to new AIDS or AIDS related progression event or death as defined by AIDS defining and/or AIDS-related illnesses.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
142476|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Total Protein)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||g/dL||Standard Deviation|Mean
142444|NCT00447902|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|After Day 1 of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
142445|NCT00447902|Secondary|Change in Viral Load From Baseline at Each Visit|Change in viral load (measured from a plasma sample) from baseline at each visitPatients with a viral load of less than 400 copies/mL at each visit as .|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
142446|NCT00447902|Secondary|Occurrence of ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48|Occurrence of greater than or equal to 1 log10 drop in viral load from baseline at all visits, including visits at Weeks 24 and 48|Baseline, 24 and 48 weeks|The trial has been stopped due to a poor enrollment|||||
142447|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Each Visit|Patients with a viral load of less than 400 copies/mL at each visit as measured from a plasma sample.|After 4 weeks of treatment until the end of the trial||||||
142448|NCT00447902|Secondary|Occurrence of Viral Load Less Than 400 Copies/mL at Weeks 24 and 48|Patients with a viral load of less than 400 copies/mL at Weeks 24 and 48 as measured from a plasma sample.|24 and 48 weeks|The trial has been stopped due to a poor enrollment|||||
142449|NCT00447902|Secondary|Virologic Response Defined as Viral Load <50 Copies/mL at Each Visit|Virologic response defined as viral load less than 50 copies/mL|After 4 weeks of treatment until the end of the trial|The trial has been stopped due to a poor enrollment|||||
142450|NCT00447902|Primary|Treatment Response at Week 48|Treatment response is a confirmed virologic response, defined as a viral load less than 50 copies/mL at two consecutive measurements at least 5 days apart, without death, permanent discontinuation, or introduction of a new antiretroviral|48 weeks|The trial has been stopped due to a poor enrollment|||||
142451|NCT00447603|Secondary|Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.|||||
142452|NCT00447603|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.|||||
142453|NCT00447603|Primary|Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study||up to 4 weeks|All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.|||||
142454|NCT00447603|Primary|Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period||Baseline and Week 4|Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.|||||
142455|NCT00447590|Secondary|Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire|Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the IWQOL Kids questionnaire through month 60 (year 5).||units on IWQOL Kids scale||95% Confidence Interval|Mean
142456|NCT00447590|Secondary|Change in Quality of Life Using the Beck Depression Inventory II (BDI)|Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years.|Baseline to 5 Years|Participants who completed the BDI II questionnaire through month 60||units on BDI scale||95% Confidence Interval|Mean
142457|NCT00447590|Secondary|Change in Subjects' Comorbid Conditions|The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved.|Baseline to 5 Years|Subjects who had a specific comorbid condition at baseline (Diabetes n=9, Dyslipidemia n=39, Hypertension n=22)||participants whose condition resolved|||Number
142458|NCT00447590|Secondary|Subject Percent Excess BMI Loss|Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60||kg/m2||95% Confidence Interval|Mean
142459|NCT00447590|Secondary|Subject Excess Weight Loss Throughout the Study|Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.|Baseline to 5 Years|Intent to treat (ITT) population with imputation at month 60||%EWL||Standard Deviation|Mean
142460|NCT00447590|Primary|Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.|"Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.~Excess Weight = baseline weight – ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years."|1 year|Intent to treat (ITT) population with imputation at month 12 (ITT population consisted of participants treated with the LAP-BAND).||percentage of participants|||Number
142477|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Sodium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
142461|NCT00447499|Secondary|Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination|Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6.|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26). Fifty-six of patients had data at Week 24.||On a Scale from -6 to 6||Standard Deviation|Mean
142462|NCT00447499|Secondary|Total Symptom Questionnaire Score at Week 24/Termination|Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10.|24 Weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).||On a Scale from -10 to 10||Standard Deviation|Mean
142463|NCT00447499|Secondary|Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.||ng/mL||Standard Deviation|Mean
142464|NCT00447499|Secondary|Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.|Blood samples taken before and 60 and 120 min after glucose load from fasting patient.|24 Weeks|Patients switched directly from octreotide who had GH level measured at the end of study.||Percent of Participants|||Number
142465|NCT00447499|Secondary|Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study|Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.|24 weeks|Patients switched directly from octreotide who had IGF-1 level measured at the end of study.||Percent of Participants|||Number
142466|NCT00447499|Secondary|Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.|Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient.|24 weeks|Patients switched directly from octreotide.||Percent of Participants|||Number
142467|NCT00447499|Primary|The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.|The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').|24 weeks|All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).||Percentage of Participants|||Number
142468|NCT00447421|Secondary|Phase 2: Overall Survival|Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.|baseline to date of death from any cause|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||months||Standard Deviation|Mean
142469|NCT00447421|Secondary|Phase 2: Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||months||Standard Deviation|Mean
142470|NCT00447421|Secondary|Phase 2: Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||months||Standard Deviation|Mean
142471|NCT00447421|Secondary|Phase 2: Complete Response Rate|Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.|baseline to measured response time|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||participants|||Number
142472|NCT00447421|Secondary|Phase 1: Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and was stopped too early to assess best overall response.||participants|||Number
142473|NCT00447421|Primary|Phase 2: Overall Response Rate|Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured progressive disease|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial. No patients were entered into the Phase 2 portion.||participants|||Number
142474|NCT00447421|Primary|Phase 1: Maximum Tolerated Dose||every cycle|This trial was terminated during the Phase 1 portion of this Phase 1/2 trial and it was too early to assess the recommended dose for Phase 2, or to estimate the maximum tolerated dose (MTD).||milligrams per square meter||Standard Deviation|Mean
142475|NCT00447382|Secondary|Adverse Events||Weeks 0-52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||events|||Number
142478|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Potassium)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
142479|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||U/L||Standard Deviation|Mean
142480|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Creatinine)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a postbaseline observation.||Umol/L||Standard Deviation|Mean
142481|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALP = alkaline phosphatase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||U/L||Standard Deviation|Mean
142482|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.~(ALAT = alanine aminotransferase)"|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||U/L||Standard Deviation|Mean
142483|NCT00447382|Secondary|Clinical Laboratory Values (Change in Biochemistry - Albumin)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||g/dL||Standard Deviation|Mean
142484|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Leucocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
142485|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Thrombocytes)|Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||10^9/L||Standard Deviation|Mean
142486|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Neutrophils)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
142487|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Monocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
142488|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Lymphocytes)|"Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
142489|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Haemoglobin)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
142490|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Eosinophils)|Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
142491|NCT00447382|Secondary|Clinical Laboratory Values (Change in Haematology - Basophilis)|"Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.~Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory."|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) of white blood cells||Standard Deviation|Mean
142492|NCT00447382|Secondary|Change From Baseline in Total Antibodies|Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir – human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||ratio||Standard Error|Mean
142493|NCT00447382|Secondary|Change From Baseline in Detemir Specific Antibodies|Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|Week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||ratio||Standard Error|Mean
142494|NCT00447382|Secondary|Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])|"point is Before Breakfast~point is 120 minutes after Breakfast~point is Before Lunch~point is 120 minutes after Lunch~point is Before Dinner~point is 120 minutes after Dinner~point is at Bedtime~point is At 03:00 A.M.~point is Before Breakfast the Following Day"|week 0, 26 and 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Deviation|Mean
142495|NCT00447382|Secondary|Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])||week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||mmol/L||Standard Error|Mean
142496|NCT00447382|Secondary|Glycaemic Control Parameters (Change in HbA1c)|HbA1c (Glycosylated haemoglobin).|week 0, week 52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||Percent (%) glycosylated haemoglobin||Standard Error|Mean
142497|NCT00447382|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.|Weeks 0-52|All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||episodes|||Number
142498|NCT00447382|Primary|Change From Baseline in Insulin Detemir – Human Insulin Cross-reacting Antibodies|Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.|week 0, week 52|FAS (Full Analysis Set) All randomised subjects exposed to at least one dose of trial product with a post-baseline observation.||ratio||Standard Error|Mean
142499|NCT00447330|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years after study start date|All patients who received treatment are included in the analysis population. However, 2 patients who never started treatment before leaving the study were excluded from this analysis of survival time.||survival time in months||90% Confidence Interval|Median
142500|NCT00447330|Secondary|Response Rate|The proportion of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disese) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.|Every 9 weeks for up to 1 year|All eligible patients.||percentage of participants||95% Confidence Interval|Number
142501|NCT00447330|Secondary|To Assess the Safety and Tolerability of the Combination of Bevacizumab, Oxaliplatin and Capecitabine in Patients With Previously Untreated Metastatic Esophagogastric Adenocarcinoma|Number of subjects who experienced an adverse event|Every 21 days|||participants|||Number
142502|NCT00447330|Primary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. PER RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years from study start date|All patients with at least one scheduled restaging who received treatment. However, an additional 3 patients who progressed before treatment are not included in this analysis.||survival time in months||90% Confidence Interval|Median
142503|NCT00447278|Secondary|Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores|Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.|Baseline, 6 months|All randomized participants who received at least one dose of study drug and had non-missing values.||correlation coefficient|||Number
142522|NCT00447226|Secondary|Incidence of ErbB2-positive Participants|The number of ErbB2-positive participants (determined by FISH assay) compared to the total number of participants screened was to be recorded. Over-expression of ErbB2 has been correlated with an overall poor prognosis. Data were not analyzed, due to early study termination.|Screening|All participants who were screened to determine their eligibility to enter into the study||participants per total screened|||Number
142549|NCT00447005|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher, serious adverse events, and adverse events resulted in discontinuation.|Up to 795 days of treatment plus 28-days follow-up|All subjects who received at least 1 dose of the study drug.||participants|||Number
142504|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)|CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of adolescent participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n=27, OEST n=31). Their data at 6 months was taken as baseline for the 12 month change."||T-Scores of units on a scale||Standard Deviation|Mean
142505|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)|CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|"Number of child participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 112, OEST n=124). Their data at 6 months was taken as baseline for the 12 month change."||T-Scores of units on a scale||Standard Deviation|Mean
142506|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||units on a scale||Standard Deviation|Mean
142507|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||units on a scale||Standard Deviation|Mean
142508|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)|The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0=“never or not at all”, 1=”sometimes or somewhat”, 2=”often or much”, 3=“very often or very much”). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst).|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||units on a scale||Standard Deviation|Mean
142509|NCT00447278|Secondary|Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)|CHIP-CE PRF: parent rated assessment of a child’s health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 6 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||T-Scores of units on a scale||Standard Deviation|Mean
142510|NCT00447278|Secondary|Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain|CHIP-CE PRF: parent rated assessment of a child’s health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 4 months, 12 months|Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.||T-Scores of units on a scale||Standard Deviation|Mean
142547|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single Dose||Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||hours||Full Range|Median
142511|NCT00447278|Primary|Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain|CHIP-CE PRF: parent rated assessment of a child’s health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, 6 months|Number of participants who received at least one dose of study drug and did not have a missing value. Results for Last Observation Carried Forward (LOCF) are included.||T-Scores of units on a scale||Standard Deviation|Mean
142512|NCT00447265|Secondary|Participant Medical Outcome Study Short Form 36 (SF-36) Mental Component Score at Baseline and Week 24|"Reported here are the participant SF-36 Mental Component scores at baseline and week 24. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions.[1] The Mental Component score of the SF-36 ranges from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.~[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey. Med Care. 1992; 30:473-483"|Baseline, Week 24|||Score on a scale|||Number
142513|NCT00447265|Secondary|Participant Medical Outcome Study Short-Form 36 (SF-36) Physical Component Score at Baseline and Week 24|"Reported here is the participant baseline and week 24 SF-36 Physical Component scores. The SF-36 measures 8 domains: physical functioning, role limitations due to physical health, body pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions[1]. The Physical Component scores of the SF-36 range from 0 to 100; 0 equals worst health state. Higher numbers reported here indicate more improvement in condition from baseline.~[1]Ref: Ware JE, Sherbourne CD. The MOS36-item short-form health survey Med Care. 1992; 30:473-483."|Baseline, Week 24|||Score on a scale|||Number
142514|NCT00447265|Secondary|Number of Participants With an A to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Renal Score|Reported here is the number of participants with a change in their BILAG Renal Score from A (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum renal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system|Baseline, Week 24|||Participants|||Number
142515|NCT00447265|Secondary|Number of Participants With a B to D Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Musculoskeletal Score|Reported here is the number of participants with a change in their BILAG Musculoskeletal Score from B (at baseline) to D (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0).A maximum musculoskeletal score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24|||Participants|||Number
142516|NCT00447265|Secondary|Number of Participants With a C to B Score Change From Baseline to Week 24 in the British Isles Lupus Assessment Group (BILAG) Mucocutaneous Score|Reported here is the number of participants with a change in their BILAG Mucocutaneous Score from C (at baseline) to B (at week 24). A single alphabetic score (A through E) is used to denote disease severity. The BILAG score is a converted numerical score (A=9, B=3, C=1, D=0, E=0). A maximum mucocutaneous score of 9 signifies higher disease activity and a score of 0 is indicative of inactive systematic lupus erythematosus (SLE) in the specified organ system.|Baseline, Week 24|||Participants|||Number
142517|NCT00447265|Secondary|Participant Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) Score at Baseline and at Early Study Withdrawal Visit|Reported here is the baseline and week 39 Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) scores. The SLEDAI is a concise measure of lupus disease activity with excellent test-retest reliability and high responsiveness to clinically important changes in the disease. The total score is derived from ratings on 24 conditions plus the Physician's Global Assessment; 0 indicates inactive disease and the maximum theoretical score is 105, with higher scores representing increased disease activity.|Baseline, Week 39 (Early Study Withdrawal Visit)|||Points on a scale|||Number
142518|NCT00447265|Secondary|Time to Participant's Renal Response|"Time to when participant achieved a renal response[1]~[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|First 24 Weeks of Study Period|||Weeks|||Number
142519|NCT00447265|Secondary|Percent of Participants Who Achieved a Renal Response at Week 24|"Percent of study participants who achieved a renal response at 24 weeks.[1]~[1]A renal response is defined as: 1) 50% reduction in proteinuria compared to baseline as measured by urinary protein: creatinine ratio; and 2) stable or improving renal function as defined by the Glomerular filtration rate (GFR) calculated based on the Modification of Diet in Renal Disease equation (Levy, AS, Coresh J, Galk E et al, National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med, 139(2): 137-47, 2003)"|Week 24|||Percent of Participants|||Number
142520|NCT00447265|Secondary|Number of Participant Adverse Events (AEs) From Baseline to Early Study Withdrawal Visit|Number of participant AEs during the trial. This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0.|39 Weeks|||Events|||Number
142521|NCT00447265|Primary|Number of Adverse Events (AEs)Grade 3 or Higher Experienced by Participant During Treatment Phase of Study|"Number of adverse events (AEs) or serious adverse events (SAEs) Grade 3 or higher experienced by participant over the duration of the treatment period. [1]~[1] This study graded the severity of AEs experienced by the study participant according to the criteria set forth in the National Cancer Institute’s Common Terminology Criteria for Adverse Events Version 3.0."|24 Weeks|||Events|||Number
142550|NCT00446992|Primary|LDL||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
142523|NCT00447226|Secondary|Incidence of MET Amplification in Gastric Cancer|The number of gastric cancer participants with MET amplification (determined by fluorescence in situ hybridization [FISH] assay) compared to the total number of gastric cancer participants screened was to be recorded. Amplification of the MET gene has been reported to be related to carcinogenesis, progression of gastric cancer, and poor prognosis. Data were not analyzed due to early study termination.|Performed on archived tissue collected at screening.|All participants with gastric cancer who were screened to determine their eligibility to enter into the study||participants per total screened|||Number
142524|NCT00447226|Secondary|Number of Participants With the Indicated Change in Cancer Antigen-125 (CA-125) Levels From Day 1|CA-125 is a “tumor marker”, found in greater concentration in tumor cells than other cells of the body. In particular, CA-125 is present in greater concentration in ovarian cancer cells than in other cells. A decreasing level generally indicates that therapy has been effective, whereas an increasing level indicates tumor recurrence.|Pre-dose and every 6 weeks until withdrawal (up to 84.1 weeks)|Participants with ovarian cancer. The number of participants for whom there are data varies at each time point, depending on how many participants had CA-125 samples.||participants|||Number
142525|NCT00447226|Secondary|Time to Disease Progression (TTP)|"Time to disease progression was calculated as the time from the start of treatment to disease progression or death due to disease progression. For participants who did not progress, the date of last contact was used and for those who died due to other causes, the date of death was used. The word used for such participants was censored. As the median value in the placebo arm was not reached (2 participants were censored and 2 were ongoing), results for the placebo arm are not displayed in the table below."|From start of treatment to disease progression/death (up to 83.3 weeks)|All Treated: all participants who received at least one dose of open-label lapatinib.||weeks||95% Confidence Interval|Median
142526|NCT00447226|Secondary|Progression-free Survival (PFS)|"Progression-free survival was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Data were not analyzed due to early study termination."|From start of treatment to disease progression/death (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.||weeks||95% Confidence Interval|Median
142527|NCT00447226|Secondary|Duration of Response|Duration of response was calculated as the time from first documented partial response (PR; >=30% decrease in the measurements of the largest lesions) or complete response (CR; disappearance of all lesions) until disease progression, the time when the participant began a new anti-cancer therapy, or death. Data were not analyzed due to early study termination.|(assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib)|All treated: all participants who received at least one dose of open-label lapatinib.||weeks||95% Confidence Interval|Median
142528|NCT00447226|Primary|Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization|The percentage of participants who did not show signs of progressive disease 12 weeks after receiving lapatinib or placebo in Stage 2 of the study (participants who maintained SD in Stage 1 were randomized to either lapatinib or placebo) was measured. Formal statistics for treatment comparison were not performed, due to early study termination. The percentage of participants displayed below includes those with CR + PR + SD.|Week 12 after randomization.|Intent-to-Treat Population: all participants randomized to study treatment in Stage 2||percentage of participants|||Number
142529|NCT00447226|Primary|Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose|Per Response Evaluation Criteria In Solid Tumors (RECIST): Complete response (CR), disappearance of all lesions; partial response (PR), >=30% decrease in the measurements of the largest lesions; stable disease (SD), insufficient shrinkage to qualify for PR or insufficient increase to qualify for progressive disease (PD); PD, >=20% increase in measurements of lesions or appearance of new lesions. Data were not fully analyzed due to early study termination.|Week 12|All treated: all participants who received at least one dose of open-label lapatinib.||participants|||Number
142530|NCT00447122|Secondary|Toxicity||1 year||||||
142531|NCT00447122|Primary|Number of Patients Who Survived at 4 Months: Overall Survival||4 months|||participants|||Number
142532|NCT00447057|Secondary|Number of Participants With Adverse Events (AEs)|Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.|Baseline up to 42.2 months|All participants who received at least 1 dose of study drug were analyzed for safety. Nonsquamous and squamous populations are combined.||participants|||Number
142533|NCT00447057|Secondary|Percentage of Participants Surviving at 1 Year|Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.|Baseline to date of death from any cause up to 1 year|"Includes nonsquamous population only.~On the Pemetrexed arm, 17 participants were censored overall and on the Pemetrexed + Erlotinib arm, 28 participants were censored overall."||Percentage participants with OS ≥1 year||95% Confidence Interval|Median
142534|NCT00447057|Secondary|Overall Survival (OS)|OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.|Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.|Pemetrexed arm: 17 (20.5%) participants censored Pemetrexed + Erlotinib arm: 28 (36.8%) participants censored||months||95% Confidence Interval|Median
142535|NCT00447057|Secondary|Time to Treatment Failure (TTTF)|"Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than “protocol complete” or “satisfactory response”. For participants who discontinued due to protocol complete or satisfactory response, or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date."|"Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than protocol complete or satisfactory response. Maximum follow-up was from Baseline to 32.2 months"|Includes nonsquamous population only.||months||95% Confidence Interval|Median
142551|NCT00446992|Primary|HDL||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
142552|NCT00446992|Primary|Cholesterol Total||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
142536|NCT00447057|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)|"CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100."|Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.||percentage of participants||95% Confidence Interval|Number
142537|NCT00447057|Secondary|Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)|"Per RECIST:~CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.~PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100."|Baseline to measured PD. Maximum follow-up was from Baseline to 34 months|Includes nonsquamous population only.||percentage of participants||95% Confidence Interval|Number
142538|NCT00447057|Primary|Progression Free Survival (PFS)|PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.|Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months|"Includes Nonsquamous population only.~In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy.~In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy."||months||95% Confidence Interval|Median
142539|NCT00447005|Secondary|The Numbers of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 795 days|Participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug (Anti-tumor Response Analysis Set).||participants|||Number
142540|NCT00447005|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 2 and 3 (s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT)|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., VEGFR2, s-VEGFR3, s-KIT, and VEGF.|Prior to the initial dose (baseline), Day 1 of Cycle 2 and at the discontinuation|Participants who received at least one study drug and completed pharmacodynamic blood sampling for at least one day (Pharmacodynamic Analysis Set); n= number of participants assessed.||percent change||Full Range|Median
142541|NCT00447005|Secondary|Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau): Multiple Dose|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||ratio||Standard Deviation|Mean
142542|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve Over Dosing Interval Tau (AUCtau): Multiple Dose|Dosing Interval was 12 hours in this study.|Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||ng*h/mL||Standard Deviation|Mean
142543|NCT00447005|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||hours||Full Range|Median
142544|NCT00447005|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple Dose||Multiple dose Cycle 1 Day 1 and 15: predose, 0.5, 1, 2, 4, 8 and 12 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set); n= number of participants assessed.||ng/mL||Standard Deviation|Mean
142545|NCT00447005|Secondary|Terminal Phase Plasma Half-Life (t1/2): Single Dose|t1/2 is the time measured for the plasma concentration to decrease by one half.|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||hours||Standard Deviation|Mean
142546|NCT00447005|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf): Single Dose|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Single dose: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, and 32 hours postdose|Participants who received at least one study drug and completed pharmacokinetic blood sampling for at least one day (Pharmacokinetic Analysis Set). Only the first 6 participants were administered a single dose.||ng*hr/mL||Standard Deviation|Mean
142553|NCT00446992|Primary|Triglycerides||Baseline and 4 week intervals|||mg/dL||Standard Deviation|Mean
142554|NCT00446992|Primary|IL-6||Baseline and 4 week intervals|||pg/mL||Standard Deviation|Mean
142559|NCT00446849|Secondary|Endoscopic Remission of UC During the Maintenance Phase at 12 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|12 Months|MPEP with non-missing data at 12 months.||Participants|||Number
142560|NCT00446849|Secondary|Quiescent UC During the Maintenance Phase at 12 Months|Quiescent UC is defined as scores of 0 for both rectal bleeding and bowel movements. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Bowel movements are assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|12 Months|MPEP with non-missing data at 12 months.||Participants|||Number
142561|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: (Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals) x 100.|12 months|MPEP with non-missing data for clinical recurrence at 12 months.||Percent of participants|||Number
142562|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: [(Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals)] x 100.|6 Months|MPEP with non-missing data for clinical recurrence at 6 months.||Percent of participants|||Number
142563|NCT00446849|Secondary|Clinical Recurrence of UC During the Maintenance Phase at 12 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|12 Months|MPEP||participants|||Number
142564|NCT00446849|Primary|Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months|Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.|6 months|Maintenance phase efficacy population (MPEP) includes all subjects who, during the maintenance phase, took at least 1 dose of study medication and had at least 1 post-dose efficacy assessment.||participants|||Number
142565|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142566|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5G|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5G: Subject response to ‘how, during the past 24 hours, pain has interfered with your enjoyment of life’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142567|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5F|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5F: Subject response to ‘how, during the past 24 hours, pain has interfered with your sleep’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142568|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5E|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5E: Subject response to ‘how, during the past 24 hours, pain has interfered with your relations with other people’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142569|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5D|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5D: Subject response to ‘how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142570|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5C|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5C: Subject response to ‘how, during the past 24 hours, pain has interfered with your walking ability’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142643|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'|Subjects self-assessed presence or absence of symptom|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||participants|||Number
142571|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5B|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5B: Subject response to ‘how, during the past 24 hours, pain has interfered with your mood’. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142572|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) – Pain Interference Question 5A|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q5A: Subject response to ‘how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142573|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142574|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142575|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142576|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142577|NCT00446797|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1|"m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.~Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine"|Days 1, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||scores on a scale||Standard Deviation|Mean
142578|NCT00446797|Secondary|Subject Assessment of Normal Function / Activity|Subject response to question: “How does your ankle injury affect your walking and normal activity?” Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can’t resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation)|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
142579|NCT00446797|Secondary|Pain Relief - MITT Population|"Subject's response to the statement My relief from starting pain is. Scale from 0 = None to 4 = Complete."|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
142580|NCT00446797|Secondary|Physician Global Assessment of Ankle Injury|Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain)|Days 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
142581|NCT00446797|Secondary|Subject's Global Assessment of Ankle Injury|Subject response to question: “Considering all the ways your ankle injury affects you, how are you doing today?” Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment||participants|||Number
142582|NCT00446797|Secondary|Number of Subjects Responding (Improving) - MITT Population|The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale|Days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).||participants|||Number
142601|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
142583|NCT00446797|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population|Assessment of ankle pain by VAS: 100 mm horizontal line, left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline|Baseline and days 2, 3 and 7|Modified intent to treat (MITT) population included subjects who were randomized, received at least one dose of study medication and had at least one follow up pain VAS score assessment (i.e. a subset of treated subjects).||scores on a scale||Standard Deviation|Mean
142584|NCT00446797|Primary|Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population|Assessment of ankle pain by VAS: 100 mm horizontal line with left end being “No Pain” & right end being “Worst Possible Pain”. Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline|Baseline and day 3|Per protocol (PP) population included subjects who were randomized, received full loading dose of study medication on day 1 and took no prohibited medications up to and including day 3, had valid baseline and day 3 VAS scores and had no major protocol violations before or during the study (i.e. a subset of treated subjects).||scores on a scale||Standard Deviation|Mean
142585|NCT00446654|Primary|Change in Baseline to 3 Months in Best Corrected Visual Acuity|"Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read).~The outcome measure presented is the difference in LogMAR between baseline and at three months."|Baseline and 3 months|Analysis was performed on all patients who received at least one treatment.||logMAR||Standard Deviation|Mean
142586|NCT00446654|Secondary|To Evaluate Possible Suppression and/or Regression of Choroidal Neovascularization||3 months||||||
142587|NCT00446654|Secondary|Safety of 2-weekly or 4-weekly Administration of CGC-11047||3 months||||||
142588|NCT00446641|Secondary|Post-treatment ARU|mean of ARU value of individual participants after 4 weeks treatment|after 4 weeks treatment|||ARU||Standard Deviation|Mean
142589|NCT00446641|Secondary|Difference of Post-treatment ARU and Baseline ARU|summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients|baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication|||change of ARU measured||Standard Deviation|Mean
142590|NCT00446641|Secondary|Any Bleeding Complications|any bleeding events causing medical attention|events ocurred during study medication after randomization|||participants|||Number
142591|NCT00446641|Secondary|Fatal or Major Bleeding Complications;|Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|events ocurred during study medication after randomization|||participants|||Number
142592|NCT00446641|Secondary|Bleeding Time (BT)|for evaluation of the extent of the bleeding time prolongation by additional cilostazol|4 weeks after reatment|||seconds||Standard Deviation|Mean
142593|NCT00446641|Secondary|Aspirin Resistance (ARU ≥ 500)|The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values|4 weeks after reatment|||participants|||Number
142594|NCT00446641|Primary|Aspirin Resistance (ARU ≥ 550)|The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients|4 weeks after treatment|||participants|||Number
142595|NCT00446563|Secondary|Percentage of Participants Who Experienced Adverse Events (AEs)|An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.|Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.||Percentage of participants|||Number
142596|NCT00446563|Secondary|Percentage of Participants Achieving Target Blood Pressure at Week 52|Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.|Week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||Percentage of participants|||Number
142597|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.||mg/l||Standard Deviation|Mean
142598|NCT00446563|Secondary|Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)||Baseline to week 52|The safety population consisted of the sample of all randomized patients who applied study medication at least once.||pg/ml||Standard Deviation|Mean
142599|NCT00446563|Secondary|Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||mm||Standard Deviation|Mean
142600|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||cm˄2||Standard Deviation|Mean
142602|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
142603|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
142604|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||ml||Standard Deviation|Mean
142605|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI|Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.|Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||Percentage||Standard Deviation|Mean
142606|NCT00446563|Secondary|Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||mm||Standard Deviation|Mean
142607|NCT00446563|Secondary|Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||mm||Standard Deviation|Mean
142608|NCT00446563|Secondary|Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients from the safety population who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||g/m˄2||Standard Deviation|Mean
142609|NCT00446563|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)||Baseline to week 52|The intention-to-treat (ITT) population consisted of all patients who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.||g/m˄2||Standard Deviation|Mean
142610|NCT00446511|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.||mmHg||Standard Deviation|Mean
142611|NCT00446511|Secondary|Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20|24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.|Core Baseline (Week 0) to Week 20|ABPM population: All ITT patients who received the 24-hour ambulatory blood pressure monitoring (ABPM) measurements at both baseline and Week 20. Patients were excluded if their baseline ABPM was measured after active treatment dose (considered invalid baseline).||mmHg||Standard Deviation|Mean
142612|NCT00446511|Secondary|Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26|Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.|Week 26|The extension ITT population consisted of all extension patients that had both baseline and at least one post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic blood pressure) during the extension. Patients were analyzed according to the treatment they were assigned to at the beginning of their extension.||Percentage of patients|||Number
142625|NCT00446446|Secondary|Duration of Response|"Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method.~PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with an objective response||months||95% Confidence Interval|Median
142613|NCT00446511|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26|After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.|Core Baseline (Week 0) to Week 26|Extension ITT population: All patients that had both baseline and at least 1 post-Week 12 assessment of any efficacy variable (sitting systolic/diastolic BP) during the extension. Baseline is the Week 0 value. Extension endpoint is the Week 26 or last observation after the core endpoint but before Week 26 carried forward value.||mmHg||Standard Deviation|Mean
142614|NCT00446511|Primary|Number of Patients With Adverse Events||Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)|Extension safety population||Participants|||Number
142615|NCT00446459|Secondary|The Number of Transplants With a Negative Crossmatch at Transplant.|The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months.|Number of Transplants with a Negative Crossmatch.|||Participant|||Number
142616|NCT00446459|Secondary|The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL).|The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months.|Enrollment to month 12.|||Participant|||Number
142617|NCT00446459|Secondary|The Number of Kidney Transplant up to 12 Months.|The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|Enrollment to month 8 or month 12 post enrollment.|||Participants|||Number
142618|NCT00446459|Primary|The Number of Subjects With a 10% Decrease in PRA Level at Month 8.||Enrollment to month 8|||Participant|||Number
142619|NCT00446459|Secondary|The Number of Subjects With Significant Infections up to Month 12.|The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study.|From enrollment to month 12.|Forty five subjects were screened, of these 37 received MMF.||Participants|||Number
142620|NCT00446446|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug.|The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months.|Safety analysis set (all enrolled participants who received at least 1 dose of panitumumab)||participants|||Number
142621|NCT00446446|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first).|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set||months||95% Confidence Interval|Median
142622|NCT00446446|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment.~PFS was analyzed using the Kaplan-Meier method."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set||months||95% Confidence Interval|Median
142623|NCT00446446|Secondary|Time to Progression|Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set||months||95% Confidence Interval|Median
142624|NCT00446446|Secondary|Rate of Disease Control|"Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD."|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set with measurable disease at Baseline||percentage of participants||95% Confidence Interval|Number
142626|NCT00446446|Secondary|Time to Response|Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed.|From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)|Full analysis set participants with objective responses||weeks||Inter-Quartile Range|Median
142627|NCT00446446|Primary|Objective Response Rate|Assessments are based on investigator’s review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).|Full analysis set (all enrolled participants who received at least 1 dose of panitumumab) with measurable disease at Baseline||percentage of participants||95% Confidence Interval|Number
142628|NCT00446290|Primary|Number of Participants With DLTs|Dose limiting toxicity (DLTs) was determined during the Wrst two cycles of treat- ment. The definitions of DLTs were as follows: (1) grade 4 neutropenia lasting for more than 5 days, or grade 3/4 neu- tropenia with fever; (2) grade 4 thrombocytopenia; (3) any other grade 3 non-hematological toxicity (excluding alope- cia); or (4) treatment delay of more than 2 weeks following the time of planned treatment. Maximal tolerated dose was defined as that the DLTs were observed in two or more patients from a cohort of two to six patients|2 years|All patients who were initially enrolled in dose escalation scheme.||participants|||Number
142629|NCT00446264|Secondary|Number of Adverse Events|The number of adverse events related to the procedure and to the immunosuppression|1 year|||number events|||Number
142630|NCT00446264|Secondary|Percentage of Time Spent in Hypoglycemia (<0.70 mg/L)|percentage of time spent in hypoglycemia derived from CGMS (Continuous Glucose Monitoring System)|1 year|||percentage of time||Standard Deviation|Mean
142631|NCT00446264|Secondary|HbA1c < 6.5%|The percentage of subjects with HbA1c < 6.5% at 1 year after the first transplant|1 year|||Percentage of participants||Standard Deviation|Mean
142632|NCT00446264|Secondary|Plasma C-peptide|Level of plasma C-peptide at 1 year after the first transplant|1 year|||ng/ml||Standard Deviation|Mean
142633|NCT00446264|Secondary|Hypoglycemic Events|Percentage of subjects free of severe hypoglycemic events from day 0 to day 365 with the day of transplant designated day 0|day 0 to day 365|||Percentage of patients||Standard Deviation|Mean
142634|NCT00446264|Primary|Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year|The percentage of insulin independents subjects with an HbA1c less than 6.5% at one year after last transplant|1 year|||Percentage of patients||Standard Deviation|Mean
142635|NCT00446251|Secondary|The Number of Subjects With a Negative Crossmatch at the Time of Transplant.||Month 12 from start of study|As per protocol each subject was entered with intention to treat.||Participants|||Number
142636|NCT00446251|Secondary|The Number of Subjects Who Experience a Change From Baseline in Their Panel of Reactive Antibody (PRA) Titers at 12 Months Post Rituximab Infusion.||Month 12 from start of study|||Participants|||Number
142637|NCT00446251|Primary|The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion.|the number of subjects who experience a decrease in their Panel of Reactive Antibodies (PRA) at 6 months and 12 months post Rituximab infusion|Month 6 from start of study|12 subjects received the full dose of Rituximab AND continued to month 6 post infusion.||Participants|||Number
142638|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||scores on a scale||Standard Deviation|Mean
142639|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Scores on a scale||Standard Deviation|Mean
142640|NCT00446199|Other Pre-specified|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Standard Deviation|Mean
142641|NCT00446199|Other Pre-specified|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Standard Deviation|Mean
142642|NCT00446199|Secondary|Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'|Subjects self-assessed presence or absence of symptom; and if present recorded average number of times per night: 1; 2 to 4; more than 4.|After 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||participants|||Number
142646|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
142647|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
142648|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
142649|NCT00446199|Secondary|Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'|Subjects self-assessed symptom severity|After 12 weeks of treatment|Full analysis set. Numbers differ from the complete full analysis set due to missing data.||participants|||Number
142650|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal Maturation Value|Calculated as (percentage of superficial cells) + 0.5 * (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||Percentages of cells||Standard Deviation|Mean
142651|NCT00446199|Secondary|Change From Baseline to Week 12 in Vaginal pH|Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.|Baseline until 12 weeks of treatment|Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.||(pH)||Standard Deviation|Mean
142652|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Scorese on a scale||Full Range|Median
142653|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.|Baseline until 12 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Scores on a scale||Full Range|Median
142654|NCT00446199|Primary|Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.|Baseline until 4 weeks of treatment|Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Full Range|Median
142655|NCT00446199|Primary|Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)|Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.|Baseline until 12 weeks of treatment|Full analysis set (Intention to Treat (ITT)) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.||Hot Flushes per week||Full Range|Median
142656|NCT00446147|Secondary|Number of Patients With Hand-foot Syndrome|Number of patients with any grade of hand-foot syndrome|Up to 2 years|||participants|||Number
142657|NCT00446147|Primary|Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome|A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.|Up to 2 years|||miligram per square meter||95% Confidence Interval|Median
142658|NCT00446134|Secondary|Relapsers at Follow-Up Visit 24|Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug.|Follow-Up Week 24|The analysis was performed using patients who had undetectable HVC RNA at their last visit on drug.||Participants|||Number
142659|NCT00446134|Secondary|Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24||Treatment Week Follow-Up 24|This analysis was performed using the Intent-to-Treat Population (ITT); undetectable HCV RNA defined as <100 copies/mL;Patients with a missing value at TW 12, TW 24 were considered Non-responders (detectable); a responder is defined as a patient with undetectable HCV RNA at FW 24 after achieving EVR at TW 12 and undetectable status at TW 24||Participants|||Number
142660|NCT00446134|Secondary|Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24|The primary safety endpoint will be the numbers of patients with hemoglobin <10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed.|Treatment Week Follow-Up 24|The secondary analysis was performed using the Safety Population and 275 patients who received at least one dose of study drug were analyzed for safety.||Participants|||Number
142671|NCT00445939|Secondary|Clinical Remission (CDAI < 150) at Week 2|Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2.|Week 2|Subjects with a clinical remission (CDAI <= 150) in the adalimumab 160 mg (Week 0/80 mg (Week 2) and adalimumab 80 mg (Week 0)/40 mg (Week 2) in full analysis set using Non-responder Imputation.||Participants|||Number
142661|NCT00446134|Primary|Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.|The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as <100 copies/mL serum HCV RNA. A PR is defined as < 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.|Treatment Week 12|The primary efficacy analysis was performed using the Intent-to-Treat (ITT) population and 275 patients who received at least one dose of study drug were analyzed for efficacy.||Participants|||Number
142662|NCT00446095|Secondary|Overall Survival (OS)|OS: Time from date of first study drug administration to the date of death.|Overall survival is measured from the time of first administration of study drug to death. (Maximum duration of treatment 511days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Days||95% Confidence Interval|Median
142663|NCT00446095|Secondary|Progression Free Survival (PFS)|PFS: Time from date of first study drug administration to the date of progressive disease as assessed according to the “Revised Response Criteria for Malignant Lymphoma”(Cheson 2007) or the date of death due to any cause, whichever occurred first.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Phase II only as was not collected in Phase I. Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Days||95% Confidence Interval|Median
142664|NCT00446095|Primary|Clinical Benefit Rate as Assessed According to the “Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).|Proportion of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Participants|||Number
142665|NCT00446095|Primary|Overall Response Rate as Assessed According to the“Revised Response Criteria for Malignant Lymphoma” (Cheson 2007).|Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Primary efficacy is based on Phase II patients only.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 12 weeks thereafter or to confirm response . (Maximum duration of treatment 511 days, Maximum duration of follow-up 812 Days)|Intention to treat (ITT) population is defined as all patients who received at least one dose of fostamatinib.||Participants|||Number
142666|NCT00446030|Secondary|Disease-free Survival (DFS) & Overall Survival (OS) of Participants|"DFS is the time from study registration until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. For participants who are removed from the study follow-up prior to documentation of the tumor recurrence, DFS will be censored at the last date the participant was known to be disease-free.~OS is the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive."|up to 10 years|"Based on a protocol amendment~this study was shortened from 10 years to 2 years~the efficacy endpoints of disease free survival, and overall survival were deleted from the protocol.~Therefore, no analysis was performed for DFS or OS."||Months||95% Confidence Interval|Median
142667|NCT00446030|Primary|Percent of Participants With Grade 3/4 Clinical Congestive Heart Failure (CHF)|The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.|up to 2 years|Safety population - all participants who received at least 1 dose of any study treatment.||Percentage of Participants||95% Confidence Interval|Mean
142668|NCT00445939|Secondary|Clinical Remission (CDAI <150) at Week 6 and Week 8|The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8|Week 6 and Week 8|Subjects who were rated as non-responders (CDAI reduction < 70) in the evaluation of clinical remission (CDAI<150) at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + adalimumab 160/80 mg.||Participants|||Number
142669|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period B|The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8.|Week 6 and Week 8|Full analysis set - subjects rated as non-responders (did not attain CDAI reduction >= 70) in the evaluation of CR-70 and CR-100 at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + 160/80 mg.||Participants|||Number
142670|NCT00445939|Secondary|Clinical Response (CR-70 and CR-100) in Period A|The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4.|Weeks 2 and Week 4|The secondary efficacy analysis was performed using descriptive statistics in randomized subjects who received at least one dose of study drug (full analysis set) in the three treatment groups: Adalimumab 160 mg/80 mg, adalimumab 80mg/40 mg, and placebo.||participants|||Number
142672|NCT00445939|Primary|The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4|CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.|4 Weeks|The primary analysis will be performed on the full analysis set (randomized subjects who received at least one dose of study drug) using the non-responder imputation for missing remission observations.||Particpants|||Number
142673|NCT00443898|Secondary|Number of Participants Assessed With Adverse Events and Serious Adverse Events|"An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.~A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage."|52 weeks|Safety Population was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All except 4 participants who were randomized to the vehicle 24 w group and one participant randomized to the terbinafine 48 w group, were included in the safety population.||Participants|||Number
142674|NCT00443898|Secondary|Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.~Clinical effectiveness was a composite binary variable defined as~Yes” if~Mycological cure (negative KOH and negative culture for dermatophytes) and~= 10% residual involvement of the target toenail~No” if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).||Percentage of Participants|||Number
142675|NCT00443898|Secondary|Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks.|"Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.~Mycological cure was a composite binary variable defined as~Yes”if :~Negative microscopy and~Negative culture for dermatophytes~No” if otherwise."|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).||Percentage of Participants|||Number
142676|NCT00443898|Primary|Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.|"Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.~and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as~Yes” if:~Mycological cure (negative KOH and negative culture for dermatophytes) and~No residual involvement of the target toenail~No” if otherwise"|52 weeks|All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF).||Percentage of Participants|||Number
142677|NCT00443872|Secondary|Mini Mental State Examination (MMSE) Scores for All Subjects|The MMSE is a general measure of cognition (i.e., measures attention, memory, visuospatial construction, etc). It has 30 items, each item representing 1 point. The total score ranges from 0-30 with 30 being a perfect score (no cognitive impairment) and 0 being the lowest score (greatest possible level of impairment). The total score is calculated by adding the scores of each item.|Baseline and 3 months|All||units on a scale||Standard Deviation|Mean
142678|NCT00443872|Secondary|Beck Anxiety Inventory Scores for All Subjects|The Beck Anxiety Inventory is a general measure of anxiety. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (severe - I could barely stand it), all questions are related to the presence of signs or symptoms of anxiety. The total possible score is 63 and a higher score represents greater anxiety. The total score is calculated by adding the responses for each of the 21 items.|Baseline and 3 months|All||units on a scale||Standard Deviation|Mean
142679|NCT00443872|Secondary|Beck Depression Inventory for All Subjects|The Beck Depression Inventory is a general measure of depression. There are 21 questions each with responses ranging from 0 (no issue or problem) to 3 (maximum issue/distress), all questions are related to emotions, mood, feelings, etc. The total possible score is 63 (higher scores represent more depression). The total score is calculated by adding the scores of the 21 items.|Baseline and 3 months|All||units on a scale||Standard Deviation|Mean
142680|NCT00443872|Secondary|PDQ-39 Quality of Life Assessment Total Scores|The PDQ-39 is a measure of quality of life, it has 8 sub scales and a total score. For this study only the total score was examined. There are a total of 39 questions related to the following 8 sub scales: ability/difficulty to perform motor activities, ability to perform daily activities, cognition, emotional well being, stigma, social support, communication, bodily discomfort; each question with 5 responses (0, no/never, 4 always). The total score is calculated by adding the scores for each of the 39 items, dividing by 39 x 4 (maximum score for all 39 items) and then multiplying by 100 to get a percentage score ranging from 0-100 with 100 representing the most disability and greatest impact on quality of life.|Baseline and 3 months|||units on a scale||Standard Deviation|Mean
142681|NCT00443872|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Scores|"The UPDRS activities of daily living sub scale has 14 questions regarding the ability to perform daily activities like dressing, eating, etc. These questions are completed by the patient and each question has 5 responses ranging from 0 (no problems) to 4 (severe disability/cannot do). The total score for this sub scale is the sum of the scores for the 14 questions (higher scores represent greater disability), maximum score is 56.~The motor assessment is completed by the investigator. There are 14 questions evaluating motor function in various body parts, representing 27 individual items (i.e., some questions, such as rigidity, are rated for 5 different body parts, other questions, such as finger tapping, are rated on both the right and left sides, and other questions are rated individually). Each item has 5 responses, 0 being none/no disability and 4 being the most severe disability. The 27 items are summed (higher scores represent greater disability); maximum score is 108."|Baseline and 3 months|All subjects completing the study were included||units on a scale||Standard Deviation|Mean
142682|NCT00443872|Primary|Barratt Impulsiveness Scale Score for Those With Impulsive Behavior|This is a measure of impulsiveness. There are 30 questions regarding the presence of impulsive and non-impulsive behaviors each scored from 1 (rarely/never) to 4 (almost always/always). The total score reflects the sum of the 30 items. A higher score represents more impulsiveness.|Baseline and 3 months|The number with ICDs at baseline||units on a scale||Standard Deviation|Mean
142683|NCT00443872|Primary|Circumference of Lower Leg/Foot at Greatest Point of Swelling for Pedal Edema|The circumference of the lower leg/ankle with the greatest swelling was measured using a standard tape measure at baseline and 12 weeks for both the right and left ankles.|Baseline and 3 months|Presence of pedal edema at baseline||centimeters||Standard Deviation|Mean
142684|NCT00443872|Primary|Neuropsychiatric Inventory (NPI) Hallucinations Scale Score for Those With Hallucinations|Report of hallucinations with insight maintained based on the hallucinations questions of the Neuropsychiatric Inventory (NPI). The participant and their caregiver are asked a series of questions to determine if hallucinations are present. If present they rate the frequency of hallucinations on a scale of 1 (rarely, less than once a week) to 4, very often (once or more daily). They also rate the severity of the hallucinations, as mild (1 - present but harmless and cause little distress), moderate (2 - distressing and disruptive) or severe (3 - very disruptive, major source of behavioral disturbance, may need meds). The frequency and severity scores are multiplied (maximum score 12, with higher scores representing more distress/disability) for the total score.|Baseline and 3 months|Patients who reported hallucinations at baseline||units on a scale||Standard Deviation|Mean
142685|NCT00443872|Primary|Epworth Sleepiness Scale Score for Those With Daytime Sleepiness|This is a measure of daytime sleepiness. The test is a list of eight situations in which one rates their tendency to become sleepy on a scale of 0, no change of dozing to 3, high chance of dozing. The total score ranges fro 0-24, with higher values representing excessive sleepiness. A score of greater than 10 represents clinically significant sleepiness.|Baseline and 3 months|Based only on the number of patients with excessive daytime sleepiness at baseline||units on a scale||Standard Deviation|Mean
142686|NCT00443872|Primary|Percentage of Participants With Reduction in Adverse Events|The primary outcome measure was the reduction of daytime sleepiness, hallucinations, pedal edema, and impulse control disorders after a reduction of dopamine agonist dose with the addition of an monoamine oxidase (MAO)-B inhibitor (orally disintegrating selegiline). Percentages of participants with reduction in individual adverse events as well as reduction in any adverse events are reported.|3 Months|77 patients enrolled in the study and 60 completed. Each patient had to have at least one of the following DA related AEs, excessive daytime sleepiness, hallucinations, pedal edema or impulse control disorder (they could have more than one AE). 60 subjects were selected based on results of previous studies (discontinued patients were replaced).||percentage of participants|||Number
142687|NCT00443820|Secondary|Safety and Tolerability Assessed by the Number of Participants With Adverse Events|Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.|52 weeks|Safety Population||Number of participants|||Number
142688|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks|"Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and <= 10% residual involvement of the target toenail.~Clinical effectiveness was a composite binary variable defined as~Yes” if:~If mycological cure (negative KOH and negative culture for dermatophytes) and~= 10% residual involvement of the target toenail~No” if otherwise"|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)||Percentage of participants|||Number
142689|NCT00443820|Secondary|Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks|Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)||Percentage of participants|||Number
142690|NCT00443820|Primary|Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks|Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.|52 weeks|Intent to treat (ITT) population, Last observation carried forward (LOCF)||Percentage of participants|||Number
142691|NCT00443781|Primary|Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)|For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of >=2 Numerical Rating Scale (NRS) points AND >33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.|Approximately 2 hours per subject|Subjects which underwent Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) consist of 1 population (N=50). Subjects which underwent either PD, F.A.D. or neither diagnostic test consist of a second population (all subjects enrolled, N=62). This is a diagnostic study. No imputation technique was used.||discs|Participants||Number
142692|NCT00443755|Other Pre-specified|Change From Baseline in Fat-Free Mass (FFM)|FFM was measured using dual energy x-ray absorptiometry (DEXA) scans and is reported in kilograms (kg).|Baseline, 3 months|Per-protocol analysis||kilograms||Standard Deviation|Mean
142693|NCT00443755|Other Pre-specified|Change From Baseline in Body Fat|Body fat is reported as a percentage of body weight.|Baseline, 3 months|Per-protocol population||percentage of body weight||Standard Deviation|Mean
142694|NCT00443755|Other Pre-specified|Change From Baseline in Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat.|Baseline, 3 months|Per-protocol population||kg/m^2||Standard Deviation|Mean
142695|NCT00443755|Secondary|Change From Baseline in the Inflammatory Biomarker Adiponectin|Adiponectin is an anti-inflammatory cytokine and is reported in milligrams per milliliter (mg/mL).|Baseline, 3 months|Per-protocol analysis||mg/mL||Standard Deviation|Mean
142699|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Plasminogen Activator Inhibitor-1 (PAI-1)|PAI-1 was measured by enzyme-linked immunosorbent assay (Diagnostica Stago Inc., Parsippany, New Jersey) and reported in nanograms per milliliter (ng/mL).|Baseline, 3 months|Per-protocol analysis||ng/mL||Standard Deviation|Mean
142700|NCT00443755|Secondary|Change From Baseline in the Thrombotic Biomarker Fibrinogen|Fibrinogen was measured by thrombin clotting rate assay (Beckman Coulter, Inc. Brea, California) and reported in milligrams/deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis||mg/dL||Standard Deviation|Mean
142701|NCT00443755|Secondary|Change From Baseline in Lipid Profile|Change in lipids were measured by the change from baseline to 3 months of triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). All were reported in milligrams/deciliter (mg/dL).|Baseline, 3 months|||mg/dL||Standard Deviation|Mean
142702|NCT00443755|Secondary|Change From Baseline in Insulin Levels|Insulin levels in the blood were measured by immunoenzymatic assay and reported in micro International Units per milliliter (mcIU/mL).|Baseline, 3 months|Per-protocol analysis||microIU/mL||Standard Deviation|Mean
142703|NCT00443755|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|HbA1c is a measure of average blood sugar levels over the preceding 3 month period. HbA1c was measured by ion-exchange chromatography and reported as a percentage.|Baseline, 3 months|Per-protocol analysis||percentage||Standard Deviation|Mean
142704|NCT00443755|Secondary|Change From Baseline in Fasting Blood Glucose Level|Glucose (sugar) was measured in the blood and reported in milligrams per deciliter (mg/dL).|Baseline, 3 months|Per-protocol analysis||mg/dL||Standard Deviation|Mean
142705|NCT00443755|Primary|Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR)|Insulin sensitivity was measured the morning after an overnight fast during an in-patient stay in the Clinical Research Unit & was determined by the mean GIR necessary to maintain euglycemia during a hyperinsulinemic (1.5 mcIU/kg of FFM per minute)-euglycemic (85-95 mg/dL) clamp. The clamp is an 8 hour process where a hand vein is catheterized to collect blood samples and intravenous lines are used to infuse glucose, saline, insulin, phenylalanine and amino acid solutions at at pre-specified times/rates. The mean GIR was calculated as the rate per kilograms of fat-free mass (FFM) during 4 hours of steady-state (hours 4-8 of the 8 hour clamp) reported as micromols/kilogram of FFM per minute. The FFM was measured by dual-energy x-ray absorptiometry (DEXA) scan. Insulin was infused with 5% essential amino acid solution (3mL/kg of FFM/hour) to prevent the insulin-dependent decrease of amino acids during insulin infusion.|Baseline, 3 months|Per-protocol analysis||micromols/kg of FFM/minute||Standard Deviation|Mean
142706|NCT00445848|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
142707|NCT00445848|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.||||||
142708|NCT00445848|Secondary|Response Rate (Complete and Partial)|Complete Response (CR): Two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial Response (PR): Two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|Only patients with measurable disease at baseline were included in the analysis. 66 of 85 patients (78%) had measurable disease at baseline.||participants|||Number
142709|NCT00445848|Secondary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|||months||95% Confidence Interval|Median
142710|NCT00445848|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.|||months||95% Confidence Interval|Median
142711|NCT00445770|Other Pre-specified|Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses||Weeks 12, 24, 52|mITT; n = evaluable participants at the specified time point.||nanograms per milliliter (ng/mL)||Standard Error|Mean
142712|NCT00445770|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mm/hr||Standard Deviation|Mean
142713|NCT00445770|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mg/dL||Standard Deviation|Mean
142714|NCT00445770|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
142715|NCT00445770|Secondary|Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|DAS: weighted calculation of joint tenderness score (Ritchie Articular Index[RAI]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
142716|NCT00445770|Secondary|Percentage of Participants With an ACR70 Response|ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Percentage of participants|||Number
142717|NCT00445770|Secondary|Percentage of Participants With an ACR50 Response|ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Percentage of participants|||Number
142718|NCT00445770|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Percentage of participants|||Number
142719|NCT00445770|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
142720|NCT00445770|Secondary|Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|"100mm line (VAS) marked by participant. Participants asked, In general how would you rate your health over the last 2-3 weeks? 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mm||Standard Deviation|Mean
142721|NCT00445770|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||mm||Standard Deviation|Mean
142722|NCT00445770|Secondary|Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Minutes||Standard Deviation|Mean
142723|NCT00445770|Secondary|Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
142724|NCT00445770|Secondary|Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Scores on a scale||Standard Deviation|Mean
142725|NCT00445770|Secondary|Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|mITT; LOCF||Tender Joints||Standard Deviation|Mean
142750|NCT00445484|Primary|6B Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
142726|NCT00445770|Secondary|Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52|Modified ITT (mITT) population: participants who received at least 1 dose of the assigned test article; Last Observation Carried Forward (LOCF)||Swollen Joints||Standard Deviation|Mean
142727|NCT00445770|Secondary|Percentage of Participants With no Progression of Joint Destruction at Week 52|Absence of joint destruction defined by 3 categories (mTSS change <=0.5, <=3.0, and <smallest detectable difference [SDD] where SDDs were scores >3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).|Baseline and Week 52|rITT||Percentage of participants|||Number
142728|NCT00445770|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT||Scores on a scale||Standard Error|Mean
142729|NCT00445770|Secondary|Change From Baseline in Erosion Score at Weeks 24 and 52|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, and Week 52|rITT||Scores on a scale||Standard Error|Mean
142730|NCT00445770|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 24|rITT||Scores on a scale||Standard Error|Mean
142731|NCT00445770|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Week 52|Radiographic intent-to-treat (rITT) population: all participants who received at least 1 dose of the assigned test article and provided radiographic data for baseline and at least 1 post-baseline visit||Scores on a scale||Standard Error|Mean
142732|NCT00445705|Secondary|Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4|PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: “improved”= score of 1-3; “no change”=score of 4; and “worse”=score of 5-7.|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all randomized patients who started study (randomized) and who received the study medication with at least one post-treatment mean daily-average-pain score.||Percentage of Patients|||Number
142733|NCT00445705|Secondary|Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4|Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.||Scores on a Scale||Standard Deviation|Mean
142734|NCT00445705|Secondary|Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4|Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The “average pain” question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.||Scores on a Scale||Standard Deviation|Mean
142735|NCT00445705|Primary|Change From Baseline in Mean Daily-Average-Pain Score at Week 4|Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.||Scores on a Scale||Standard Deviation|Mean
142816|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage of participants|||Number
142736|NCT00445679|Secondary|Covi Anxiety Scale Score Mean Change From Baseline|Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||scores on a scale||95% Confidence Interval|Mean
142737|NCT00445679|Secondary|Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline|HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||scores on a scale||95% Confidence Interval|Mean
142738|NCT00445679|Secondary|Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline|The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject’s assessment of an improvement in pain.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||scores on a scale||95% Confidence Interval|Mean
142739|NCT00445679|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and 8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||units on a scale||95% Confidence Interval|Mean
142740|NCT00445679|Secondary|Clinical Global Impressions Scale–Severity of Illness (CGI-S) Scores|CGI-S is a global rating scale that measures the severity of a subject’s disease. Using a 7-point scale, the clinician rates the severity of the patient’s mental illness at the time of the assessment, relative to the clinician’s experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||subjects|||Number
142741|NCT00445679|Secondary|Clinical Global Impressions Scale–Improvement (CGI-I) Scores|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation. Number of participants analyzed reflects the final on-therapy population.||subjects|||Number
142742|NCT00445679|Primary|Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|8 weeks|The intent-to-treat (ITT) population included all subjects randomly assigned to treatment who had a baseline HAM-D17 evaluation, took at least 1 dose of double-blind test article, and had at least 1 postbaseline HAM-D17 evaluation.||percentage of responders|||Number
142743|NCT00445588|Secondary|6months -Progression-free Survival Rate|defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up|At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up|||percentage of participants||95% Confidence Interval|Number
142744|NCT00445588|Primary|Overall Survival|death. measured by time of first day of treatment until date of death, assessed up to 2 years.|Time of first day of the treatment to death, assessed up to 2 years|||months||95% Confidence Interval|Median
142745|NCT00445549|Secondary|The Number of Participants With Adverse Events|Here are the total # of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|22 months|||Participants|||Number
142746|NCT00445549|Primary|Number of Participants With Clinical Efficacy|Defined as complete response (CR), partial response (PR), or disease stabilization lasting 6 months or longer per RECIST criteria. CR-total disappearance of all evaluable disease. PR->30% reduction in the sum of the longest diameters (LD) of target lesions. Stable disease (SD) is <30% decrease and <20% increase in the sum of the LD of all target lesions. See the protocol Link module for full RECIST criteria.|24 weeks|||participants|||Number
142747|NCT00445484|Primary|23F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
142748|NCT00445484|Primary|19F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
142749|NCT00445484|Primary|14F Antibody Response to Prevnar Vaccine in Peripheral Blood|Serum IgG levels against the PVC serotype were measured by ELISA|basline and 8 weeks after second vaccination|Patients who showed evidence of disease progression while on study were not included in the analysis.||fold change||Standard Error|Mean
142751|NCT00445432|Other Pre-specified|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
142752|NCT00445432|Other Pre-specified|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148|The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
142753|NCT00445432|Other Pre-specified|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 148|"IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms & their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life [e.g., feeling of fatigue all of the time]; 7=good quality [e.g., feeling of fatigue none of the time]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
142754|NCT00445432|Other Pre-specified|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 148|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
142755|NCT00445432|Other Pre-specified|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 148|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||units on a scale||Standard Deviation|Mean
142756|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||participants|||Number
142757|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||participants|||Number
142758|NCT00445432|Other Pre-specified|Number of Participants Who Had Clinical Remission at Week 148|Clinical remission = Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)|Data is reported as observed cases. No imputation technique was used.||participants|||Number
142780|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 8|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
142759|NCT00445432|Secondary|Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
142760|NCT00445432|Secondary|Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health).|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
142761|NCT00445432|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality (e.g., feeling of fatigue none of the time). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life."|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
142762|NCT00445432|Secondary|Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
142763|NCT00445432|Secondary|Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of open-label treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug). Last observation carried forward (LOCF) used for missing data.||Participants|||Number
142764|NCT00445432|Secondary|Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment|modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.||units on a scale||Standard Deviation|Mean
142765|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab (not placebo) during adalimumab induction study and who received >= 1 dose of DB study drug during this study). NRI (CR-100 not achieved) used for missing data for DB treatments; LOCF for OL treatment.||Participants|||Number
142815|NCT00445146|Secondary|CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed.||cells/mm^3||Standard Deviation|Mean
142766|NCT00445432|Secondary|Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment|Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score >= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.|Week 52 of double-blind treatment|OL efficacy set (assigned to OL treatment at Week 0, received >= 1 dose of OL study drug) and mFAS (participants who had received adalimumab [not placebo] during adalimumab induction study and who received >= 1 dose of DB study drug during this study). Nonresponder imputation (NRI) (CR-70 not achieved) used for DB treatments; LOCF for OL treatment.||Participants|||Number
142767|NCT00445432|Primary|Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment|Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) <150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is >= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.|Week 52 of double-blind treatment|Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.||Participants|||Number
142768|NCT00445341|Primary|Response Rate (Complete Response (CR) and Partial Response (PR))|Response was assessed by the Cheson criteria. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.(LDH) definitely assignable to the lymphoma. All lymph nodes must have regressed to normal size (</= 1.5 cm in greatest diameter if > 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to </= 1 cm or by more than 75% in the sum of the products of the greatest diameters (SPD). Spleen, if considered to be enlarged before therapy, must have regressed in size. Partial response is a >/= 50% decrease in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >/= 50% in the SPD. Bone marrow is irrelevant for determination of a PR.|2/16/2007 - 1/20/2011|||Participants|||Number
142769|NCT00445341|Primary|Number of Participants With Adverse Events (e.g. Toxicity)|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|47 months|||Participants|||Number
142770|NCT00445328|Secondary|Thrombocytopenia|Subjects with thrombocytopenia (low platelets).|Day 21|Intent to Treat (ITT)||participants|||Number
142771|NCT00445328|Primary|Composite of Objectively Verified Thromboembolic Events|Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.|Day 21|Intent to treat (ITT)||participants|||Number
142772|NCT00445328|Secondary|Allergic Reactions (Drug-related)|Subjects with drug-related allergic reactions|Day 21|Intent to treat (ITT)||participants|||Number
142773|NCT00445328|Secondary|Bleeding - Major or Minor|Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.|Day 21|Intent to treat (ITT)||participants|||Number
142774|NCT00445328|Secondary|Stroke - Ischemic or Hemorrhagic|Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography|Day 21|Intent to treat (ITT)||participants|||Number
142775|NCT00445328|Secondary|All Cause Mortality|Subjects with death from any cause: end of study.|Day 14, Day 21 (End of Study)|Intent to treat (ITT)||participants|||Number
142776|NCT00445328|Primary|Confirmed Thromboembolic Events|Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.|Day 21|Intent to treat (ITT) set: all subjects who were randomized, received at least 1 dose of study drug and had undergone at least 1 test of primary efficacy assessment.||participants|||Number
142777|NCT00445315|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Variants Resistant to PF-00868554||Screening up to Day 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
142778|NCT00445315|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at Day 8|HCV RNA levels were determined using the Abbott RealTime HCV polymerase chain reaction (PCR) assay (lower limit of detection [LOD] = 12 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening Day 0 and Day 1 pre-dose measurements. The plasma HCV RNA data was log10 transformed, and the change in log10 HCV RNA at Day 8 post-dose from baseline was calculated.|Baseline, Day 8|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.||log10 copies/mL||Standard Deviation|Mean
142779|NCT00445315|Primary|Day 8 to Day 1 Ratio of the 6 Beta-Hydroxyl Cortisol to Cortisol Ratios|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0); 0 to 24 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
142781|NCT00445315|Primary|Ratio of 6 Beta-Hydroxyl Cortisol to Cortisol: Day 1|Urine 6 beta-hydroxyl cortisol and cortisol concentrations were measured using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS).|-24 to 0 hours (pre-dose) on Day 1 (Day 0)|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
142782|NCT00445315|Primary|Renal Clearance (CLr): Day 8|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||mL/minute||Standard Deviation|Geometric Mean
142783|NCT00445315|Primary|Renal Clearance (CLr): Day 1|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||mL/minute||Standard Deviation|Geometric Mean
142784|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 8|Percent of dose recovered unchanged in urine during the dosing interval=100 (cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||percent dose recovered||Standard Deviation|Geometric Mean
142785|NCT00445315|Primary|Percent of Dose Recovered Unchanged in Urine (Ae%): Day 1|Percent of dose recovered unchanged in urine during the dosing interval=100*(cumulative amount of drug recovered unchanged in urine [Ae] divided by dose), where the dosing interval is 12 hours.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||percent dose recovered||Standard Deviation|Geometric Mean
142786|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 8|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||nanogram||Standard Deviation|Geometric Mean
142787|NCT00445315|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine (Ae): Day 1|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|0 to 12 hours, 12 to 24 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Urine collection interval was 12 hours and not 8 hours; therefore, urinary PK parameters were not calculated for three times daily regimens.||nanogram||Standard Deviation|Geometric Mean
142788|NCT00445315|Primary|Observed Accumulation Ratio for Cmax (Rac Cmax)|Rac Cmax was calculated as, maximum observed plasma concentration on Day 8 (Cmax) divided by maximum observed plasma concentration on Day 1(Cmax).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
142789|NCT00445315|Primary|Observed Accumulation Ratio (Rac)|Rac was calculated as, area under the curve from time zero to end of dosing interval on Day 8 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1(AUCtau).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 1; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ratio||Standard Deviation|Geometric Mean
142790|NCT00445315|Primary|Plasma Decay Half-Life (t1/2): Day 8|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. The t1/2 of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hour||Standard Deviation|Mean
142791|NCT00445315|Primary|Minimum Observed Plasma Trough Concentration (Cmin): Day 8|The Cmin of PF-04691502 was assessed following repeated oral dose administration for 8 days (multiple dose PK).|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose on Day 8|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ng/mL||Standard Deviation|Geometric Mean
143116|NCT00442611|Secondary|Change in Pulmonary Function Tests|"FVC (Forced Vital Capacity) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest possible breath.~DLCO (Diffusing capacity of the lung for carbon monoxide) is the extent to which oxygen passes from the lungs to the blood."|6 months|||% Predicted||Standard Deviation|Mean
142792|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 8|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ng*hour/mL||Standard Deviation|Geometric Mean
142793|NCT00445315|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Day 1|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 8 hours for three times daily regimens and 12 hours for the twice daily regimens.|0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||ng*hour/mL||Standard Deviation|Geometric Mean
142794|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||hour||Full Range|Median
142795|NCT00445315|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||hour||Full Range|Median
142796|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 8||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post-dose|PP analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the PK parameters.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
142797|NCT00445315|Primary|Maximum Observed Plasma Concentration (Cmax): Day 1||0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose for twice daily dose; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hours post-dose for three times daily dose|Per Protocol (PP) analysis set included all participants who received PF-00868554 and had sufficient plasma concentration data to enable calculation of the pharmacokinetics (PK) parameters.||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
142798|NCT00445302|Secondary|Number of Participants in Overall Safety Summary of Adverse Events (TEAE)|Number of participants with adverse events (AEs) collected from Day 1 (post plerixafor administration) to Day 3. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|up to Day 3|The safety analyses were performed on the Safety Population which consisted of all subjects who received plerixafor.||participants|||Number
142799|NCT00445302|Primary|Dose-Normalized Area Under the Plerixafor Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24h)|Evaluation of AUC0-24 hour following a single dose of 240 µg/kg plerixafor administered on Day 1. AUC0-24 was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population||hr*ng/mL/ug||Standard Deviation|Mean
142800|NCT00445302|Secondary|Change From Baseline in Absolute White Blood Cell (WBC) Counts at Day 2|Change in absolute white blood cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = absolute white blood cells at 24 hours post dose - absolute white blood cells at Baseline.|Baseline and Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.||cells/mm^3||Standard Deviation|Mean
142801|NCT00445302|Secondary|Change From Baseline in Absolute CD34+ Cell Counts at Day 2|Change in circulating CD34+ cells from baseline to Day 2 (24 hours post-plerixafor) following a single dose of plerixafor. Change from baseline = CD34+ cell count at 24 hours post dose - CD34+ cell count at Baseline.|Baseline, Day 2|An intent-to-treat approach was used to calculate the outcome measure in each arm/group.||cells/mm^3||Standard Deviation|Mean
142802|NCT00445302|Primary|Dose-Normalized Maximum Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered on Day 1. Cmax was normalized by dose.|Pre-dose of plerixafor to 24 hours post-plerixafor|Intent-to-treat population||ng/mL/ug||Standard Deviation|Mean
142803|NCT00445263|Secondary|Troponin Peak. Left Ventricular Ejection Fraction Before Hospital Exit. Length of Stay in USIC and Hospital. Hemorrhagic Complications.||d30||||||
142804|NCT00445263|Secondary|Coronarographic Criteria : TIMI Score at the Beginning and the End of the Procedure; Existence of an Intra-coronary Thrombus||d30||||||
142805|NCT00445263|Secondary|Therapeutic Failure (Well Defined) During the First 6 Hours. Clinical Evolution and Electrocardiography||until the exit from the hospital and at d30.||||||
142806|NCT00445263|Primary|Mortality, Myocardial Infarction and Revascularization in Emergency||d30|||participants|||Number
142807|NCT00445224|Primary|Visual Analog Pain Scale|Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain|8 week|||centimeters||Standard Deviation|Mean
142808|NCT00445224|Secondary|Hip Abduction Strength|Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer|8 week|||(Newton*meters)/(Weight*Height)||Standard Deviation|Mean
142809|NCT00445224|Secondary|Objective Function by Step-down Task for 30 Seconds||Baseline, Mid, and Post-Intervention||||||
142810|NCT00445224|Secondary|Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent||Baseline, Mid and Post-Intervention||||||
142811|NCT00445224|Secondary|Strength by Isometric Dynamometer||Baseline, Mid, and Post-Intervention||||||
142812|NCT00445224|Primary|Subjective Function by Lower Extremity Functional Scale Report Form||Baseline, Mid-Intervention, and Post-Intervention||||||
142813|NCT00445224|Primary|Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)|0 to 10 cm line with 0 representing no pain and 10 representing severe pain|weekly|||centimeter||Standard Deviation|Mean
142814|NCT00445146|Secondary|Incidence of Mortality|The percentage of participants who died was summarized.|Up to Week 408 plus 30 days|Safety Analysis Set||percentage of participants|||Number
142817|NCT00445146|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set with available data were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.||percentage of participants|||Number
142818|NCT00445146|Secondary|HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Efficacy Analysis Set (enrolled participants who received at least 1 dose of EVG and had at least 1 postbaseline HIV-1 RNA or CD4 cell count measurement) with available data were analyzed.||log10 copies/mL||Standard Deviation|Mean
142819|NCT00445146|Secondary|Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||U/L||Standard Deviation|Mean
142820|NCT00445146|Secondary|Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||U/L||Standard Deviation|Mean
142821|NCT00445146|Secondary|Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||U/L||Standard Deviation|Mean
142822|NCT00445146|Secondary|Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||10^3 cells/µL||Standard Deviation|Mean
142823|NCT00445146|Secondary|White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||10^3 cells/μL||Standard Deviation|Mean
142824|NCT00445146|Secondary|Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||10^6 cells/μL||Standard Deviation|Mean
142825|NCT00445146|Secondary|Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Safety Analysis Set with available data were analyzed.||g/dL||Standard Deviation|Mean
142826|NCT00445146|Secondary|Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality|A 'marked abnormality’ was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.||percentage of participants|||Number
142827|NCT00445146|Secondary|Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.|Up to Week 408 plus 30 days|Participants in the Safety Analysis Set with at least 1 postbaseline measurement were analyzed.||percentage of participants|||Number
142828|NCT00445146|Secondary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events|Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to Week 408 plus 30 days|Safety Analysis Set||percentage of participants|||Number
142829|NCT00445146|Primary|Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event||Up to Week 408 plus 30 days|Safety Analysis Set: enrolled participants who received at least 1 dose of EVG||percentage of participants|||Number
142830|NCT00445003|Secondary|Change in Optical Coherence Tomography Retinal Volume|Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively|Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||mm^3||Standard Deviation|Mean
142831|NCT00445003|Secondary|Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema|Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.|14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Eyes|||Number
142832|NCT00445003|Secondary|Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema||14 weeks to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Eyes|||Number
142833|NCT00445003|Secondary|Change in Visual Acuity From Baseline|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 56-weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Letter Score||Standard Deviation|Mean
142900|NCT00444600|Primary|Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis. followed intention to treat principle.||Letters|Participants|Standard Deviation|Mean
142834|NCT00445003|Secondary|Total Optical Coherence Tomography Retinal Volume|Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.|Baseline to 14-weeks|Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants.||mm^3||Standard Deviation|Mean
142835|NCT00445003|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness||Baseline to 14 weeks|Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.||Microns||Inter-Quartile Range|Median
142836|NCT00445003|Secondary|Additional Treatments for Diabetic Macular Edema|Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.|14 weeks to 56-weeks|||Eyes|||Number
142837|NCT00445003|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 14 weeks|Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used.||Letter Score||Standard Deviation|Mean
142838|NCT00444951|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination||Day 0 to Day 7 Post-vaccination|Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)||Participants|||Number
142839|NCT00444951|Secondary|Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination||Baseline (Day 0) and Day 28 After Vaccination|4-Fold rise titers were determined in the per-protocol population.||Percentage of Participants|||Number
142840|NCT00444951|Primary|Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination||Baseline (Day 0) and Day 28 after vaccination|Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).||Titers (1/dil)||95% Confidence Interval|Geometric Mean
142841|NCT00444925|Post-Hoc|Diary Dry Rates|Diary dry rate: number of subjects with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Week 1, Week 4, Week 12|FAS; only subjects with baseline urgency urinary incontinence >0 per 24 hours are included; n=number of subjects in the respective category at observation (Week 1, Week 4, Week 12).||participants|||Number
142842|NCT00444925|Secondary|Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).|HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo, Tolterodine ER, and Fesoterodine, respectively.||score on scale||Standard Error|Least Squares Mean
142843|NCT00444925|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).|Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.|Baseline, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to Week 12 for placebo n=289; Tolterodine ER n=589; Fesoterodine n=571.||score on scale||Standard Error|Least Squares Mean
142844|NCT00444925|Secondary|Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.|Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||participants|||Number
142845|NCT00444925|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC).|Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.|Baseline, Week 1, Week, 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||participants|||Number
142846|NCT00444925|Secondary|Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.|Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||score on scale||Standard Error|Least Squares Mean
142847|NCT00444925|Secondary|Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.|Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||score on scale||Standard Error|Least Squares Mean
142848|NCT00444925|Secondary|Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.|Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
142849|NCT00444925|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.|Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline severe urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||severe urgency episodes per 24 hours||Standard Error|Least Squares Mean
142850|NCT00444925|Secondary|Percent Change From Baseline of Urgency Episodes Per 24 Hours.|Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
142851|NCT00444925|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.|Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline urgency episodes >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||urgency episodes per 24 hours||Standard Error|Least Squares Mean
142852|NCT00444925|Secondary|Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
142853|NCT00444925|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.|Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline nocturnal micturitions >0 per 24 hours, non-missing change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||nocturnal micturitions per 24 hours||Standard Error|Least Squares Mean
142854|NCT00444925|Secondary|Percent Change From Baseline of Micturitions Per 24 Hours.|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100% *(Week 12 or 4 - baseline)/baseline).|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing percent change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
142855|NCT00444925|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours.|The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||number of micturitions per 24 hours||Standard Error|Least Squares Mean
142856|NCT00444925|Secondary|Change From Baseline in Mean Voided Volume Per Micturition.|Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.|Baseline, Week 1, Week 4, Week 12|FAS; (n)=number of subjects with non-missing numerical change from baseline to the respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||voided volume per micturition||Standard Error|Least Squares Mean
142962|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142857|NCT00444925|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours.|UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.|Baseline, Week 1, Week 4, Week 12|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1, Week 4 [LOCF], or Week 12 [LOCF]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||percent change||Full Range|Median
142858|NCT00444925|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.|UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.|Baseline, Week 1, Week 4|FAS; Subjects reporting this symptom at baseline; (n)=number of subjects with baseline UUI>0 per 24 hours, non-missing change from baseline to respective post-baseline value (Week 1 or Week 4 [Last Observation Carried Forward (LOCF)]) for placebo, Tolterodine ER, and Fesoterodine, respectively.||number of episodes per 24 hours||Standard Error|Mean
142859|NCT00444925|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).|UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.|Baseline, Week 12|Full analysis set (FAS): took at least 1 dose of assigned treatment, contributed data to at least 1 baseline or post-baseline efficacy assessment, and excluded 107 subjects from two study sites with significant Good Clinical Practices (GCP) deviations. The decision to exclude that data was made while the study was still blinded.||number of episodes per 24 hours||Standard Error|Mean
142860|NCT00444912|Secondary|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Evaluable population of participants who received a stem cell transplant and had a 12-month assessment.||participants|||Number
142861|NCT00444912|Secondary|The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day||Day 5|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.||percentage of total cells||Full Range|Median
142862|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant||13 months (12 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 12 months post-transplant.||cells / μL||Full Range|Median
142863|NCT00444912|Secondary|Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant||Approximately 7 months (6 months post-transplant)|Evaluable population of participants who received a stem cell transplant and had assessment performed 6 months post-transplant.||cells / μL||Full Range|Median
142864|NCT00444912|Secondary|Median Number of Days to Lymphocyte Engraftment|Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5*10^8/L. Time to engraftment corresponded to the first day that criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had lymphocyte engraftment.||days||Full Range|Median
142865|NCT00444912|Secondary|Median Number of Days to Platelet (PLT) Engraftment|Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20*10^9/L without transfusion for the preceding 7 days or platelet counts ≥50*10^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PLT engraftment.||days||Full Range|Median
142866|NCT00444912|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days from transplantation to PMN engraftment which was defined as PMN counts ≥0.5*10^9/L for 3 consecutive days or ≥1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Days post transplantation (approximately Day 40)|Evaluable population of participants who received a stem cell transplant and had PMN engraftment||days||Full Range|Median
142867|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to reach the target of 5*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥5*10^cells/kg collected during apheresis.||days||Full Range|Median
142868|NCT00444912|Secondary|Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg|Median number of apheresis days in each treatment arm to collect a minimum of 3*10^6 CD34+ cells/kg.|Days 5-8|Evaluable population of participants who achieved ≥3*10^cells/kg collected during apheresis.||days||Full Range|Median
142869|NCT00444912|Secondary|Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration|Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).|Days 4-5|Evaluable population of participants with peripheral blood CD34+ measurements on Days 4 and 5.||fold increase||Full Range|Median
142870|NCT00444912|Secondary|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis.|Days 5-8|Full Analysis Set (FAS) includes all participants who received at least 1 dose of plerixafor.||CD34+ cells (*10^6 / kg)||Full Range|Median
142871|NCT00444912|Primary|Summary of Adverse Events (AEs)|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.|Day 1 and up to Day 59 (maximum time before start of chemotherapy)|Safety Population: all participants who received at least 1 dose of study drug (G-CSF, plerixafor, or rituximab)||participants|||Number
142963|NCT00443729|Primary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142872|NCT00444795|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST)|The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of study treatment, average of 23.2 weeks.|Intent-to-treat Analysis Set: Participants who administered Sutene at least once.||Percentage of Participants||95% Confidence Interval|Number
142873|NCT00444795|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs|An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely” or “no” (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.|Safety Analysis Set||Percentage of Participants||95% Confidence Interval|Number
142874|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period|"Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|weeks 36 up to 47 weeks|Safety Population for repeat treatment.||Participants|||Number
142875|NCT00444626|Secondary|Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period|"Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure.~If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive."|Weeks 1-36|Number of patients randomized to initial treatment phase. Safety Population.||Participants|||Number
142876|NCT00444626|Secondary|Participant Product Preference at Week 36|Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Participants|||Number
142877|NCT00444626|Secondary|Participant Product Preference at Week 24|Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Participants|||Number
142878|NCT00444626|Secondary|Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator’s Assessment of Wrinkle Severity at Week 24|Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Participants|||Number
142879|NCT00444626|Secondary|Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36|"Mean change between Baseline and the Week 36 score (Baseline minus week 36 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 36|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Units on a scale|Participants|Standard Deviation|Mean
142880|NCT00444626|Secondary|Participant’s Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)|The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain).|Day 1|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Units on a scale||Standard Deviation|Mean
142964|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142881|NCT00444626|Primary|Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24|"This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.~Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds."|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.||Units on a scale|Participants|Standard Deviation|Mean
142882|NCT00444600|Other Pre-specified|Major Ocular Adverse Events During First Year of Follow-Up||1 Year|||Eyes|Participants||Number
142883|NCT00444600|Secondary|Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year||from baseline to 1 Year|||mm^3|Participants|Standard Deviation|Mean
142884|NCT00444600|Secondary|Mean Optical Coherence Tomography Retinal Volume at 1 Year||1 Year|||mm^3|Participants|Standard Deviation|Mean
142885|NCT00444600|Other Pre-specified|Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year|Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause.|1 Year|Study participants with 2 study eyes are assigned to the non-sham group. Multiple events within a study participant are only counted once per event.||Participants|||Number
142886|NCT00444600|Secondary|Percentage of Eyes Receiving Laser at the 48 Week Visit (%)||1 Year|||Eyes|Participants||Number
142887|NCT00444600|Other Pre-specified|Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year|Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing.|from baseline to 1 Year|||Eyes|Participants||Number
142888|NCT00444600|Other Pre-specified|Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year|113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833|from baseline to 1 Year|||Eyes|Participants||Number
142889|NCT00444600|Other Pre-specified|Eyes With Alternative Treatments Prior to the 1-year Visit|Each combination of treatment only counted once.|1 Year|||Eyes|Participants||Number
142890|NCT00444600|Secondary|Number of Laser Treatments Received Prior to the 1 Year Visit|One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment.|1 Year|Number who completed the 1-year visit.||Eyes|Participants||Number
142891|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
142892|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
142893|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness|Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
142894|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|from baseline to 1 Year|||Letters||Standard Deviation|Mean
142895|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema||from baseline to 1 Year|||Letters||Standard Deviation|Mean
142896|NCT00444600|Primary|Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline||from baseline to 1 Year|||Letters|Participants|Standard Deviation|Mean
142897|NCT00444600|Other Pre-specified|Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening|Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.|1 Year|||Eyes|Participants||Number
142898|NCT00444600|Other Pre-specified|Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year||1 Year|||Eyes|Participants||Number
142899|NCT00444600|Primary|Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|from baseline to 1 Year|For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis.||Eyes|Participants||Number
142901|NCT00444600|Secondary|Number of Injections in First Year|Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections.|from baseline to 1 year|Sham+prompt laser group listed median excludes 56 eyes among 163 participants with 2 study eyes that were unmasked at baseline because the participant's other eye was in the ranibizumab+deferred laser group, precluding sham injections for the study eye assigned to sham+prompt laser.||Injections|Participants|Inter-Quartile Range|Median
142902|NCT00444600|Secondary|Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year|Negative change denotes an improvement.|from baseline to 1 year|||microns|Participants|Standard Deviation|Mean
142903|NCT00444587|Secondary|Mean Left Ventricular Ejection Fraction|Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat. It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||percent of blood pumped from LV chamber]||Standard Deviation|Mean
142904|NCT00444587|Secondary|Hematology Safety Laboratory Parameter: Mean Platelets Counts|Participants in the study were evaluated for the platelets at Visit 1 and final study assessments. Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Number of cells x 10^9/L||Standard Deviation|Mean
142905|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts|"Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments.~Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice."|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||percent of differential||Standard Deviation|Mean
142906|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts|Participants in the study were evaluated for the total leukocytes up to 5 years. Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||10^9 leukocytes/L||Standard Deviation|Mean
142907|NCT00444587|Secondary|Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels|Participants in the study were evaluated for the Hemoglobin up to 5 years. Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||grams per deciliter||Standard Deviation|Mean
142908|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels|Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium. Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Millimole per liter||Standard Deviation|Mean
142909|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Albumin Levels|Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments. Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||gram per liter||Standard Deviation|Mean
142910|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels|Participants in the study were evaluated for the total bilirubin and serum creatinine. Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Micromole/liter||Standard Deviation|Mean
142965|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142966|NCT00443729|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142911|NCT00444587|Secondary|Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels|Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years). Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)|The Safety Population included all participants who entered the trial and received at least one dose of trial medication. n = the number of participants analyzed at a given time point.||Units per liter||Standard Deviation|Mean
142912|NCT00444587|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 5 years|The Safety Population included all participants who entered the trial and received at least one dose of trial medication.||Number of participants|||Number
142913|NCT00444587|Secondary|Overall Survival|Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause. Overall survival was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants with data available were analyzed.||Days||95% Confidence Interval|Median
142914|NCT00444587|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death. Median time to treatment failure was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. Only those participants who experienced treatment failure were analyzed.||Days||95% Confidence Interval|Median
142915|NCT00444587|Secondary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments. CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : >=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease. It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator. CBR was also assessed by computer. Clinical benefit rate was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR, PR and SD. Study design was changed to single arm study because herceptin use after progression herceptin-based therapy become widespread.||Percentage of participants||95% Confidence Interval|Number
142916|NCT00444587|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount. It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0. Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions. Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter. Objective response rate was not assessed for ‘Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set participants with measurable disease with CR or PR||Percentage of participants||95% Confidence Interval|Number
142917|NCT00444587|Primary|Median Time to Disease Progression|Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy’ group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.|Up to 5 years|The Full-Analysis-Set included all participants who were enrolled and had at least one valid primary efficacy variable on active treatment. n = Numbers of participants included in this analysis.||Days||95% Confidence Interval|Median
142918|NCT00444535|Secondary|Progression-free Survival|Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population||weeks||95% Confidence Interval|Median
142967|NCT00443729|Other Pre-specified|Number of Patients With Drug-related LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142968|NCT00443729|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
143117|NCT00442611|Secondary|Change in Oral Aperture and Hand Extension||6 months||||||
142919|NCT00444535|Secondary|Clinical Benefit|Clinical benefit is defined as defined as the percentage of participants with evidence of a confirmed CR (complete resolution of lesions observed at baseline) or PR (30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) at any time or stable disease (insufficient response to qualify for CR or PR, and insufficient increase in tumor burden to qualify for progressive disease [20% increase in sum of longest diameters, new lesions, or symptomatic progression]) for at least 24 weeks per RECIST.|Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population||Percentage of participants|||Number
142920|NCT00444535|Secondary|Overall Response|The percentage of participants with measurable disease with a best response of partial response (PR, 30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) or complete response (CR, complete resolution of lesions observed at baseline) per RECIST was measured. The first assessment of overall response was at Week6; however, the participants were assessed for response until treatment ended.|Week 6 through End of Study (until end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)|ITT Population. Analysis was done on 45 of 52 participants, as 7 participants had withdrawn before Week 6.||Percentage of participants|||Number
142921|NCT00444535|Primary|Percentage of Participants Reaching Week 12 Without Disease Progression|The progression-free survival rate was evaluated by the investigator after 12 weeks of treatment and was defined as the number of participants with no evidence of disease progression (20% increase in sum of longest diameters, new lesions, or symptomatic progression) per Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause for a minimum of 84 days (12 weeks).|Week 12|Intent-to-Treat (ITT) Population: all enrolled participants, regardless of whether or not they received any study medication||Percentage of participants|||Number
142922|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.||percentage of participants|||Number
142923|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
142924|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
142925|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
142926|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (12 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.||percentage of participants|||Number
142927|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (6 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
142969|NCT00443729|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142970|NCT00443729|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142928|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (4 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
142929|NCT00444457|Other Pre-specified|Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after dose (2 months of age)|Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.||percentage of participants|||Number
142930|NCT00444457|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
142931|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||observed percentage of participants||95% Confidence Interval|Number
142932|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.||observed percentage of participants||95% Confidence Interval|Number
142933|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||observed percentage of participants||95% Confidence Interval|Number
142934|NCT00444457|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.||observed percentage of participants||95% Confidence Interval|Number
142935|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.||observed percentage of participants||95% Confidence Interval|Number
142971|NCT00443729|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142936|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of participants with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.||observed percentage of participants||95% Confidence Interval|Number
142937|NCT00444457|Primary|Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.|1 month after the infant series (7 months of age)|Evaluable immunogenicity population. Combined 13vPnC group includes participants who received pilot lot 1, pilot lot 2, or manufacturing lot; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.||observed percentage of participants||95% Confidence Interval|Number
142938|NCT00444457|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (7 Months of age)|Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations; (n)=number of participants with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.||GMC mcg/mL||95% Confidence Interval|Geometric Mean
142939|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)|May be used to define the success of treatment. Not done|Week 4|The results of exploratory analyses are not available.|||||
142940|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|"May be used to offer patients a strategy of treatment during the initial phase and in the long term.~Not done"|Day 0|The results of exploratory analyses are not available.|||||
142941|NCT00444275|Secondary|Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire|May be used to evaluate the severity of symptoms during the initial visit. Not done|Day 0|The results of exploratory analyses are not available.|||||
142942|NCT00444275|Secondary|Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study|Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.|12 weeks - maintenance treatment phase|||Participants|||Number
142943|NCT00444275|Secondary|Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment|Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression)|16 weeks|||Percent of participants with failure|||Number
142944|NCT00444275|Secondary|Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)|Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)|4 to 16 weeks|871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data)||Scores on scale||Standard Deviation|Mean
142945|NCT00444275|Secondary|Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase|No possibility to describe as only 2 patients took ASA|4 weeks|Outcome measure not possible to describe as only 2 patients took Aspirin.|||||
142946|NCT00444275|Secondary|Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).|"Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator.~The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From Never for the Lowest Frequency to Every Day for the Highest, 6 Others Assess the Severity of Symptoms From Not at All to Strong. The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item."|4 weeks|||Percentage of participants|||Number
142947|NCT00444275|Primary|Efficacy of Three Strategies of Long-term Treatment|Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?|16 weeks|||Percentage of participants with failure|||Number
142972|NCT00443729|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
145110|NCT00426751|Secondary|Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI|The number of participants who died and/or experienced re-MI within 6 month after PCI was measured.|until 6 Month (Day 180) after index-MI|Safety Population||participants|||Number
142948|NCT00444106|Secondary|Efficacy of Polymerase Chain Reaction (PCR) Adjusted Malaria Cure Rates of the Three Treatment Regimens at Days 14, 28 and 42|Percentage of patients with clearance of asexual parasitemia (observed by optical microscopy) within 7 days of initiation of trial treatment without recrudescence within 14, 28 and 42 days respectively after initiation of treatment. Patients with recurrent parasitemia and paired PCR results were classified as either a new infection (different paired genotypes) or a recrudescence (matching paired genotypes). Patients without paired PCR results or ambiguous results were classified as treatment failures.|Days 14, 28 and 42|Full Analysis Set defined as all randomized patients with confirmed malaria at baseline, who had at least one dose of study drug and had at least one relevant post-baseline efficacy assessment.||Percentage of Participants||95% Confidence Interval|Number
142949|NCT00444106|Secondary|Relationship Between Changes in Auditory Function and Treatment Groups|ABR Wave III latency (ms) changes from baseline to Day 7 in the three drug exposure groups.|From Baseline to Day 7|||ms||95% Confidence Interval|Mean
142950|NCT00444106|Secondary|Auditory Changes Following 3 Days of Treatment at Days 3, 7, 28, and 42 Days as Assessed by Pure Tone Thresholds Assessments (a Type of Hearing Test)|Audiometric measurements such as pure-tone threshold (air conduction tested at 250 to 8000 HZ) day 3, 7, 28 and 42 following initiation of treatment, including changes from baseline. Pure-tone average (PTA) calculated for each ear by averaging the pure-tone threshold values at 500, 1000, 2000 and 3000 HZ.|Baseline (Day 1), 3, 7, 28 and Day 42|Safety per protocol patients who had a valid ABR at baseline and on the specified day were included.||dB||95% Confidence Interval|Mean
142951|NCT00444106|Primary|Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)|"To demonstrate the safety of artemether-lumefantrine after 3 days of treatment in patients with acute, uncomplicated falciparum malaria by testing the null hypothesis that the rate of auditory abnormalities is ≥ 15% in the population treated with artemether-lumefantrine as assessed by ABR at Day 7 following initiation of treatment compared with their baseline values. An auditory nerve abnormality is here defined as a greater than 0.30 ms change in Wave III latency from baseline to Day 7. Exact Pearson-Clopper two-sided 95% confidence limits were constructed for all three treatment groups."|7 days|Safety per protocol set defined as all the randomized patients who took at least 80% of the entire recommended dose and had a valid baseline and Day 7 ABR Wave III latency evaluation and did not use any meds having an ototoxic effect.||Percentage of Participants||95% Confidence Interval|Number
142952|NCT00444067|Other Pre-specified|Incidence of Post-Operative Surgical Site Infections (SSIs)|"•Percentage of participants who incur an SSI within 90 days post-procedure determined by clinical diagnosis~SSIs were diagnosed and classified in accordance with the Centers for Disease Control (CDC) criteria for evaluation and diagnosis of nosocomial surgical site infections and were classified as one of the following (Superficial, Deep or Organ/Space)."|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with SSIs between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.||percentage of participants||95% Confidence Interval|Number
142953|NCT00444067|Other Pre-specified|Incidence of Post-Operative CSF Leaks|"Percentage of participants with CSF leaks within 90 days post-operatively as determined from clinical diagnosis by one of the following methods:~CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 90 days post-procedure; or~CSF leak confirmation by diagnostic testing within 90 days post-procedure; or~CSF leak confirmation by clinical evaluation within 90 days post-procedure"|90 Days|Fisher’s Exact Test was used to test for a difference in the proportions of subjects with CSF leaks between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.||percentage of participants||95% Confidence Interval|Number
142954|NCT00444067|Primary|Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)|"Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as:~A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds."|Intra-operative|The primary analysis for the primary efficacy endpoint was performed using a two-sided Fisher’s Exact Test to test for a difference in the true success rates in obtaining a watertight closure between treatments.||percentage of participants||95% Confidence Interval|Number
142955|NCT00443729|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
142956|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142957|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142958|NCT00443729|Secondary|Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142959|NCT00443729|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142960|NCT00443729|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
142961|NCT00443729|Primary|Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142973|NCT00443729|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142974|NCT00443729|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142975|NCT00443729|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||24 Weeks|Full analysis set; one patient was excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.||Participants|||Number
142976|NCT00443703|Secondary|Median Percent Change From Baseline in Serum Triglyceride at Week 24|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
142977|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142978|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142979|NCT00443703|Secondary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142980|NCT00443703|Secondary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24||Baseline and Week 24|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142981|NCT00443703|Primary|Median Percent Change From Baseline in Serum Triglyceride at Week 12|Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.|Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Median
142982|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142983|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142984|NCT00443703|Primary|Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142985|NCT00443703|Primary|Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12||Baseline and Week 12|Patients who had both baseline and at least one post-baseline measurement were included in the analysis||Percent Change||Standard Deviation|Mean
142986|NCT00443703|Other Pre-specified|Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks|Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142987|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to LAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142988|NCT00443703|Other Pre-specified|Number of Patients With Serious LAEs Through 24 Weeks|Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142989|NCT00443703|Other Pre-specified|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142990|NCT00443703|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142991|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142992|NCT00443703|Other Pre-specified|Number of Patients That Discontinued Due to CAEs Through 24 Weeks||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142993|NCT00443703|Other Pre-specified|Number of Patients That Died by 24 Week Last Patient Last Visit||24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
143036|NCT00443430|Secondary|Clinical Remission on Medication|6 months of clinical inactive disease|12 months or end of study|all participants receiving study medications||participants|||Number
143037|NCT00443430|Secondary|Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events||Over 12 months maximum study participation per subject|all participants that received study medications||events|||Number
142994|NCT00443703|Other Pre-specified|Number of Patients With Serious Drug-related CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142995|NCT00443703|Other Pre-specified|Number of Patients With Drug-related CAEs Through 24 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142996|NCT00443703|Other Pre-specified|Number of Patients With Serious CAEs Through 24 Weeks|Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose|24 Week last patient last visit|All patients who took study medication were included in the analysis||participants|||Number
142997|NCT00443703|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product|24 Week last patient last visit|All patients who took study medication were included in the analysis||Participants|||Number
142998|NCT00443703|Primary|Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24||Week 24|Full analysis set; two patients were excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.||Participants|||Number
142999|NCT00443651|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Change From Baseline at Weeks 24 and 48|The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Units on a scale||Standard Deviation|Mean
143000|NCT00443651|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Good and Moderate Responses at Weeks 24 and 48|Improvement in the post-baseline DAS 28-ESR score from baseline was used to determine the EULAR responses of moderate response and good response. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. For a post-baseline score ≤ 3.2, an improvement > 0.6 to ≤ 1.2 was a moderate response and ≥ 1.2 a good response. For a post-baseline score > 3.2 to ≤ 5.1, an improvement > 0.6 was a moderate response. For a post-baseline score > 5.1, an improvement ≥ 1.2 was a moderate response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
143001|NCT00443651|Secondary|Percentage of Patients Achieving Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS 28-ESR) Remission and DAS 28-ESR Low Disease Activity Scores at Weeks 24 and 48|DAS 28-ESR was calculated using counts of tender and swollen joints (28 joints, 28TJC and 28SJC), a patient assessment (PA) of disease activity (DA) in previous 24 hours on a visual analog scale (no DA to maximum DA), and ESR at the current visit, using the following formula: 0.56 × 28TJC + 0.28 × 28SJC + 0.70 × ln(ESR) + 0.014 × PADA. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. DAS28-ESR Remission was defined as a DAS 28-ESR score of < 2.6. DAS28-ESR Low Disease Activity was defined as a DAS28-ESR score of ≤ 3.2.|Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab). There were 401 patients in the rituximab 1000 mg and 176 patients in the 500 mg safety populations. n = number of patients with non-missing DAS28-ESR last observation carried forward scores at Weeks 24 and 48 in the safety populations.||Percentage of participants|||Number
143002|NCT00443651|Secondary|Percentage of Patients With an Improvement of 20%, 50%, and 70% in American College of Rheumatology (ACR) Scores (ACR20/50/70) From Baseline at Weeks 24 and 48|Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Baseline to Week 24 and Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
143003|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the Second Course (Optional Retreatment) of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From start of the second course of rituximab treatment through Week 48|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
143038|NCT00443430|Primary|Proportion of Participants Who Attain Inactive Disease by 6 Months||6 months after initiation of study intervention|all participants receiving study medications||participants|||Number
152549|NCT00364949|Primary|17-hydroxyprogesterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/dl||Standard Deviation|Mean
143004|NCT00443651|Secondary|Percentage of Patients Who Developed a Serious Adverse Event (SAE) During or Within 24 Hours of Rituximab Infusions|The percentage of patients developing a SAE during or within 24 hours of a rituximab infusion is reported separately for each of the 2 infusions in the first course of treatment (Days 1 and 15) and the second course of treatment (optional retreatment during Weeks 24 to 40). See the Primary Outcome Measure for a definition of a SAE.|From start of rituximab treatment through 24 hours|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
143005|NCT00443651|Primary|Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment|An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.|From first treatment with rituximab (Day 1) through Week 24|Safety population: All patients who were enrolled in the study and received any study drug (rituximab).||Percentage of participants|||Number
143006|NCT00443599|Secondary|Neurodevelopmental Evaluation||1 and 3 years of age||||||
143007|NCT00443599|Secondary|Nutritional Status||Measured during participant's ICU stay||||||
143008|NCT00443599|Secondary|Endocrine Function||Measured during participant's ICU stay||||||
143009|NCT00443599|Secondary|Immune Function||Measured during participant's ICU stay||||||
143010|NCT00443599|Secondary|Cardiac Function||Measured during participant's ICU stay||||||
143011|NCT00443599|Secondary|Mortality||Measured during participant's hospital stay and at 30-day and 1-year follow-ups||||||
143012|NCT00443599|Secondary|Duration of Endotracheal Intubation||Measured during participant's ICU stay||||||
143013|NCT00443599|Secondary|Duration of Hospital Stay||Measured at the end of participant's hospital stay||||||
143014|NCT00443599|Secondary|Duration of ICU Stay||Measured at the end of participant's ICU stay||||||
143015|NCT00443599|Primary|Cardiac Index (CI)||Measured 24 hours after cardiopulmonary bypass surgery||||||
143016|NCT00443599|Primary|Incidence of Nosocomial Infections in the Cardiac ICU|Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria.|Measured during participant's ICU stay, a median duration of 3 days.|||infections / 1000 pt days|||Number
143017|NCT00443560|Secondary|Duration of Labor Analgesia|Time in minutes from initiation of labor analgesia until delivery of the infant|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis was per protocal||minutes||Inter-Quartile Range|Median
143018|NCT00443560|Secondary|Number of Participants With Breakthrough Pain in the First Stage of Labor|Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced.|Supplemental analgesia in first stage of labor (<24 hours)|Analysis was per protocol||participants|||Number
143019|NCT00443560|Primary|Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor|At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued.|Second stage of labor up to 3 hours|Analysis was per protocal||participants|||Number
143020|NCT00443534|Other Pre-specified|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.|||||
143021|NCT00443534|Other Pre-specified|Progression-Free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.|||||
143022|NCT00443534|Other Pre-specified|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, every 2 months until death or up to 2 years after the last dose of study treatment|Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.|||||
143023|NCT00443534|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 after last dose of study treatment|Intent to treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.||participants|||Number
143083|NCT00442962|Secondary|Time to Initial Virological Failure|Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.|Throughout study|All participants enrolled are included.||weeks||95% Confidence Interval|Number
143024|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||participants|||Number
143025|NCT00443456|Other Pre-specified|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||participants|||Number
143026|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||participants|||Number
143027|NCT00443456|Primary|Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value|Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg|8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||participants|||Number
143028|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
143029|NCT00443456|Other Pre-specified|Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
143030|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
143031|NCT00443456|Other Pre-specified|Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Observed Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.||mmHg||Standard Deviation|Mean
143032|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
143033|NCT00443456|Primary|Change in Diastolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
143034|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of This Long-term Study|Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)|Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
143035|NCT00443456|Primary|Change in Systolic Blood Pressure From Baseline of the Preceding Study|Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)|Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks|Full Analysis Set, Last Observation Carried Forward||mmHg||Standard Deviation|Mean
143039|NCT00443352|Primary|Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).|Number of participants for analysis was modified intention to treat - anyone who took at least one dose of duloxetine||days||Standard Deviation|Mean
143040|NCT00443209|Secondary|Percentage of Participant Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from mild, moderate or severe migraine headache (Grade 1, 2, or 3) at baseline to no pain (Grade 0) 2 hours post-dose.|2 hours post-dose (Up to 18 months)|The Full Analysis Set (FAS) population consisted of all participants who were randomized and reported at least one treated migraine attack with at least one post-treatment efficacy evaluation.||Percentage of Migraine Attacks||Standard Deviation|Mean
143041|NCT00443209|Primary|Percentage of Participants With At Least One Vital Sign Measurement Outside Predefined Limits of Change|Predefined limits of change were established for vital sign measurements: Systolic Blood Pressure (>=180 mm Hg and 20 mm Hg increase OR <=90 mm Hg and 20 mm Hg decrease), Diastolic Blood Pressure (>=105 mm Hg and 15 mm Hg increase OR <=50 mm Hg and 15 mm Hg decrease), Pulse (>=120 beats per minute [bpm] and 15 bpm increase OR <=50 bpm and 15 bpm decrease), Body Temperature (>38º C [oral equivalent]) and Respiratory Rate (>25 or increase of 10 OR <5 or decrease of 10 [per minute]). Participants were monitored for vital sign measurements outside predefined limits of change for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
143042|NCT00443209|Primary|Percentage of Participants With At Least One Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants were monitored for laboratory AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
143043|NCT00443209|Primary|Percentage of Participants With At Least One Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. Participants were monitored for clinical AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The APAT population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
143044|NCT00443209|Primary|Percentage of Participants With At Least One Triptan-Related Adverse Experience (AE)|Triptan-related AEs are defined as: chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia. Participants were monitored for triptan-related AEs for 14 days after any dose of study drug.|Within 14 days of any dose of study drug (Up to 18.5 months)|The All-Patients-As-Treated (APAT) population consisted of all participants who received at least one dose of study drug.||Percentage of Participants|||Number
143045|NCT00443118|Secondary|• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks||1 day of life and 30 days after birth||||||
143046|NCT00443118|Secondary|Days on CPAP||after birth and during hospitalization up to four weeks|||days||Standard Deviation|Mean
143047|NCT00443118|Secondary|Days on Mechanical Ventilation||after delivery and before four weeks|||days||Standard Deviation|Mean
143048|NCT00443118|Secondary|• Need for Mechanical Ventilation or CPAP||during hospitalization|||participants|||Number
143049|NCT00443118|Secondary|Days on Oxygen||after birth and during hospitalization up to four weeks|||days||Standard Deviation|Mean
143050|NCT00443118|Secondary|• Use of Oxygen Treatment Beyond the Delivery Room||during hospitalization|||participants/|||Number
143051|NCT00443118|Secondary|• Incidence of Air Leaks|included pneumothorax and Pneumomediastinum|after birth and during hospitalization up to four weeks|||participants|||Number
143052|NCT00443118|Secondary|• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)||first week of life|||participants|||Number
143053|NCT00443118|Secondary|Apgar Scores at 1 and 5 Minutes|categorized Apgar score 1 min <=3 and categorized Apgar score 5 min <=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.|1-5 minutes of life|||participants|||Number
143054|NCT00443118|Secondary|• Need for Chest Compression and/or Medications||after 2 minutes of life|||participants|||Number
143055|NCT00443118|Secondary|• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.||after 2 minutes of life|||percentage of participants|||Number
143056|NCT00443118|Secondary|• SpO2 Value at 2 Minutes of Life.||2 minutes of life|the pulse-oximeter was reliable at 2 minutes in 69% of the cases in both groups.||percentage of oxygen saturation||Standard Deviation|Mean
143057|NCT00443118|Secondary|Time the Newborn Takes to Reach a HR > 100 Bpm||2 minutes of life|||minutes||Inter-Quartile Range|Mean
143058|NCT00443118|Primary|Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.||2 minutes of life|The analysis was performed by intention to treat||percentage of participants|||Number
143084|NCT00442962|Secondary|Time to Initial Virologic Response|Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.|Throughout study|All enrolled participants included.||weeks||95% Confidence Interval|Number
150892|NCT00380250|Secondary|Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline|Any bowel movement not associated with rescue medication use|Change from baseline for month 2|ITT with LOCF||SBM/week||Standard Deviation|Mean
143059|NCT00443053|Secondary|Number of Any Adjudicated Bleeding Events at Days 47 and 77|The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population||events|||Number
143060|NCT00443053|Secondary|Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77|Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population||events|||Number
143061|NCT00443053|Secondary|Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77|Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated “On-Treatment,” defined as from randomization up to the last injection +4 days.|Days 47 (or last dose plus 4 days) and 77|As-Treated Population: randomized participants who received at least one dose of study treatment, as actually received||events|||Number
143062|NCT00443053|Secondary|Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77|The number of participants requiring surgery was measured.|Days 47 and 77|ITT Population||participants|||Number
143063|NCT00443053|Secondary|Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77|VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.|Days 47 and 77|ITT Population||participants|||Number
143064|NCT00443053|Secondary|Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 77|ITT Population||participants|||Number
143065|NCT00443053|Primary|Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47|VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.|Baseline to Day 47|Intent-to-Treat (ITT) Population: all randomized participants||participants|||Number
143066|NCT00443040|Secondary|Laboratory Values|Changes in laboratory values.|Daily for 38 days||||||
143067|NCT00443040|Secondary|Adverse Events|Adverse events grouped by body system|Daily for 38 days||||||
143068|NCT00443040|Secondary|Post-operative Analgesic Use||Daily for 38 days||||||
143069|NCT00443040|Secondary|Nasogastric Tube Re-insertion|Proportion of subjects with nasogastric tube re-insertion|Daily for 38 days||||||
143070|NCT00443040|Primary|Time to Return of Upper and Lower GI Function|The time to first bowel movement or the time to tolerating solid food, whichever occurs later.|Daily for 38 days|As the study was terminated early due to poor enrollment (31 of a planned 114 subjects were randomized and evaluable), no formal efficacy analyses were conducted.||hours||Standard Deviation|Mean
143071|NCT00443040|Secondary|Pain Score||Daily for 38 days||||||
143072|NCT00443040|Secondary|Vomiting Score||Daily for 38 days||||||
143073|NCT00443040|Secondary|Nausea Score||Daily for 38 days||||||
143074|NCT00443040|Secondary|Time to Writing of Hospital Discharge Order||Daily for 38 days||||||
143075|NCT00443040|Secondary|Time to First Bowel Movement||Daily for 38 days||||||
143076|NCT00443040|Secondary|Time to First Passage of Flatus||Daily for 38 days||||||
143077|NCT00443040|Secondary|Time to Tolerating Solid Food|Time to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal|4 hours of ingesting a meal||||||
143078|NCT00442962|Secondary|Late Change in CD4 Count From Baseline|Change in CD4+ lymphocyte counts between week 48 study visit and baseline.|At week 48|Participants with a CD4+ lymphocyte cell count result from the week 48 study visit.||cells/mm^3||Standard Deviation|Mean
143079|NCT00442962|Secondary|Time to First Dose Modification|Time from starting study treatment to first dose/drug modification.|Throughout study|All enrolled participants who started study treatment.||weeks||95% Confidence Interval|Number
143080|NCT00442962|Secondary|Percentage of Participants With Late Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Week 48|Participants with ultra-sensitive (detectable to 50 copies/mL) plasma HIV-1 RNA result available from week 48 visit.||percentage||95% Confidence Interval|Number
143081|NCT00442962|Secondary|Early Changes in CD4 Count From Baseline|Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.|At weeks 0(baseline), 4, 8, 16, 24|Intent to treat (study treatment status and history ignored); missing measurements ignored.||cells/mm^3||Standard Deviation|Mean
143082|NCT00442962|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)||Throughout study|All enrolled participants included.||weeks||95% Confidence Interval|Number
143086|NCT00442962|Secondary|Percentage of Participants With Early Virologic Suppression|Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml|At Weeks 24|ITT (ignoring current study treatment status and history); missing values ignored and closest value to week 24 used if multiple results available. 2 fewer results available compared to primary outcome b/c testing by ultrasensitive assay may have been retrospective.||percentage of participants||95% Confidence Interval|Number
143087|NCT00442962|Secondary|Time to First Safety Event|Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study|All enrolled participants who started study treatment (which in this case, matches the number of participants enrolled.)||weeks||95% Confidence Interval|Number
143088|NCT00442962|Primary|Percentage of Participants With Early Virologic Response|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml|At Week 24|Intention to treat (ignoring current study treatment status or history); closest measurement to week 24 used; missing measurements ignored. Exact binomial confidence interval calculated using method of Blyth-Still-Casella.||percentage of participants||95% Confidence Interval|Number
143089|NCT00442936|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants who took both active and placebo study drug were counted in the active group.|Up to 48 hours after first dose of study drug|The populaton consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.||Participants|||Number
143090|NCT00442936|Primary|Number of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 14 days after last dose study drug. Participants who took both active and placebo study drug were counted in the active group.|Up to 14 days after last dose of study drug|The population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken at the time of the AE.||Participants|||Number
143091|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 to 24 Hours Post-Dose|TMF at 2 to 24 hours post-dose is defined as TMF at 2 hours post-dose with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose, no return of mild/moderate/severe headache within 24 hours and no presence of phonophobia, photophobia, nausea or vomiting within 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 to 24 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 to 24 hours post-dose.||Participants|||Number
143092|NCT00442936|Secondary|Number of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post-dose is defined as PF at 2 hours post-dose without any of the following migraine-related symptoms: phonophobia, photophobia, nausea or vomiting at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one assessment for phonophobia, photophobia, nausea and vomiting within 2 hours post-dose.||Participants|||Number
143093|NCT00442936|Secondary|Number of Participants With Sustained Pain Freedom (SPF) From 2 to 24 Hours Post-Dose|SPF is defined as PF at 2 hours post-dose with no return of mild/moderate/severe headache through 24 hours post-dose, and with no administration of either the optional second dose of study drug or any rescue medication between 2 and 24 hours post-dose.|2 to 24 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, had at least one pain score measurement within 2 hours post-dose, and had at least one pain score measurement at between 2 and 24 hours post-dose.||Participants|||Number
143094|NCT00442936|Primary|Number of Participants With Absence of Nausea at 2 Hours Post-Dose|Participants were asked if they experienced any nausea. The number of participants who experienced no nausea at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline nausea assessment, and had at least one nausea assessment within 2 hours post-dose.||Participants|||Number
143095|NCT00442936|Primary|Number of Participants With Absence of Phonophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to sound. The number of participants who experienced no phonophobia (sensitivity to sound) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline phonophobia assessment, and had at least one phonophobia assessment within 2 hours post-dose.||Participants|||Number
143096|NCT00442936|Primary|Number of Participants With Absence of Photophobia at 2 Hours Post-Dose|Participants were asked if they experienced any sensitivity to light. The number of participants who experienced no photophobia (sensitivity to light) at 2 hours post-dose was determined.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline photophobia assessment, and had at least one photophobia assessment within 2 hours post-dose.||Participants|||Number
143097|NCT00442936|Primary|Number of Participants With Pain Relief (PR) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PR at 2 hours post-dose is defined as a shift from a moderate or severe migraine headache (Grade 2 or 3) at baseline to mild or no pain (Grade 1 or 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.||Participants|||Number
143173|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT||mg||Standard Error|Least Squares Mean
143098|NCT00442936|Primary|Number of Participants With Pain Freedom (PF) at 2 Hours Post-Dose|Participants were asked to rate their migraine headache severity with ratings of 0=No pain, 1=Mild pain, 2=Moderate pain, and 3=Severe pain. PF at 2 hours post-dose is defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0) at 2 hours post-dose.|2 hours post-dose|The population consisted of all participants who were randomized, took at least one dose of study drug, recorded a baseline pain score, and had at least one pain score measurement within 2 hours post-dose.||Participants|||Number
143099|NCT00442897|Secondary|Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment|If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.|After 12 weeks of the treatment|All patient treated (APT) approach||Participants|||Number
143100|NCT00442897|Primary|Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment|Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)|After 6 weeks of treatment|The analysis used all patient treated (APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.||Participants|||Number
143101|NCT00442702|Secondary|Participants With Adverse Events|Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.|Randomization to Month 10 (final visit)|Safety population||participants|||Number
143102|NCT00442702|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions|Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.|From randomization to Month 9|Safety population included all randomized patients who received at least one dose of trial medication and a safety follow-up, according to the treatment received.||participants|||Number
143103|NCT00442702|Secondary|Change in Hemoglobin Concentration From Baseline Over Time||From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.|"Intent-to-treat population, including all randomized patients. n refers to the number of patients for whom data was available at each time point."||g/dL||Standard Deviation|Mean
143104|NCT00442702|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period|A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.|Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).|Per Protocol population consisted of all randomized patients who had received at least one dose of trial medication and who have no major protocol violation. Data missing at the end of the evaluation period were handled using the last observation carried forward method (LOCF).||g/dL||Standard Deviation|Mean
143105|NCT00442689|Primary|Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period|Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)|6 months|||L/min||Standard Deviation|Mean
143106|NCT00442689|Primary|Change in Resting Energy Expenditure (REE) Over the Study Period|Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)|6 months|||Kcal/day||Standard Deviation|Mean
143107|NCT00442689|Primary|Change in Disposition Index|Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)|6 months|||min^-1||Standard Deviation|Mean
143108|NCT00442689|Primary|Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period|Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)|6 months|||percentage of body mass||Standard Deviation|Mean
143109|NCT00442689|Primary|Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI|Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)|6 months|||L||Standard Deviation|Mean
143110|NCT00442689|Primary|Change in High-density Lipoprotein (HDL) Levels During Study Period|Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)|6 months|||mg/dL||Standard Deviation|Mean
143111|NCT00442689|Primary|Change in Low-density Lipoprotein (LDL) Levels Over the Study Period|Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)|6 months|||mg/dL||Standard Deviation|Mean
143112|NCT00442611|Secondary|Change in Serum Cytokine Profile||6 months||||||
143113|NCT00442611|Secondary|Change in Serum Autoantibody Profile||6 months||||||
143114|NCT00442611|Secondary|Change in Scleroderma Health Assessment Questionnaire|"The HAQ-DI includes 20 items in 8 functional domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) assessing the patient’s usual abilities in the past seven days. Each item is scored on a 0-3 scale (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=unable to do). The use of assistive devices for any domain increases the domain score by 1 point to a maximum of 3. The overall score is calculated by summing the highest item score in each of the domains and dividing the sum by 8, with an overall score of 0 indicating no disability, and a score of 3 indicating severe disability.~The time points compared were 6 months to baseline (6 months minus baseline)."|6 months|||HAQ-DI score||Standard Deviation|Mean
143115|NCT00442611|Secondary|Change in Digital Ulcerations||6 months||||||
143118|NCT00442611|Primary|Change in Modified Rodnan Skin Score|Modified Rodnan Skin Score measures skin thickness and is the sum of scores from 17 surface anatomic areas rated on a 0–3 scale (0=normal skin; 1=mild thickness; 2=moderate thickness; 3=severe thickness with inability to pinch the skin into a fold). Total modified Rodnan Skin Score ranges from 0 (best possible outcome) to 51 (worst possible outcome).|6 months|||MRSS score||Standard Deviation|Mean
143119|NCT00442598|Secondary|Overall Survival|Time from initiation of study drug to death.|Median measured in months, until death or censorship at analysis.|||months||Full Range|Median
143120|NCT00442598|Secondary|Progression-free Survival|Time from initiation of study drug to disease progression or death on study|Median measured in months|||months||Full Range|Median
143121|NCT00442598|Secondary|Objective Response Rate|Objective response rate measured by RECIST v1.0|Duration of study, up to 18 weeks.|||participants|||Number
143122|NCT00442598|Primary|CA 125 Response Rate|Reduction in blood levels of CA 125 of >50% from baseline, confirmed at the next study cycle.|Duration of study, up to 18 weeks.|||participants|||Number
143123|NCT00442572|Secondary|Mean Change From Baseline in Triiodothyronine and Thyroxine|The Triiodothyronine (T3) and thyroxine (T4) values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||picomole/liter||Standard Deviation|Mean
143124|NCT00442572|Secondary|Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)|The TSH was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||milli-international units/liter||Standard Deviation|Mean
143125|NCT00442572|Secondary|Mean Change From Baseline in Blood Glucose|The blood glucose was measured for change from baseline. All blood glucose values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||millimoles/ liter||Standard Deviation|Mean
143126|NCT00442572|Secondary|Mean Change From Baseline in Creatinine and Uric Acid|The creatinine and uric acid values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||micromole/liter||Standard Deviation|Mean
143127|NCT00442572|Secondary|Mean Change From Baseline in Blood Urea|The blood urea was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||millimoles/liter||Standard Deviation|Mean
143128|NCT00442572|Secondary|Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct|The laboratory parameters included bilirubin indirect and bilirubin direct. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||milligrams/deciliter||Standard Deviation|Mean
143129|NCT00442572|Secondary|Mean Change From Baseline in Protein and Indirect Albumin|The clinical chemistry parameters included indirect protein and albumin. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and no intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Gram/deciliter||Standard Deviation|Mean
143130|NCT00442572|Secondary|Mean Change From Baseline in Clinical Chemistry|The clinical chemistry parameters included alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP). All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Units/Litre||Standard Deviation|Mean
143131|NCT00442572|Secondary|Mean Change From Baseline in Hematology|The hematology parameters included erythrocytes, leucocytes, basophils, eosinophils, lymphocytes, monocytes, thrombocytes. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||10^9/L||Standard Deviation|Mean
143132|NCT00442572|Secondary|Mean Change From Baseline in Hemoglobin|The hemoglobin values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Gram/deciliter||Standard Deviation|Mean
143133|NCT00442572|Secondary|Mean Change From Baseline in HBsAg Levels|An early decrease in HBsAg from baseline to Weeks 12 or 24 has been identified as further on-treatment predictor for sustained HBsAg clearance and virological response in HBeAg negative participants.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis.||copies/mL||95% Confidence Interval|Mean
143145|NCT00442546|Secondary|Overall Pain Relief Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
143146|NCT00442546|Secondary|Overall Satisfaction Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, and Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
143134|NCT00442572|Secondary|Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis|Fibrosis-4 (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) are non-invasive scoring systems, which are calculated on the basis of laboratory tests that indicates the level of liver fibrosis. The APRI scores are calculated based on Aspartate Aminotransferase (AST) levels and platelet counts whereas FIB-4 scores are calculated based on platelets, ALT, AST and age. For APRI, the scores are interpreted as ≤ 0.5 is 81% sensitive and 50% specific for a diagnosis of significant fibrosis in chronic hepatitis C (CHC), where as a cut-off > 1.5 is 35% sensitive and 91% specific for the diagnosis of significant fibrosis. The majority of biomarker panels will produce inconclusive results for a proportion of participants falling within the indeterminate range (between 0.5 and 1.5) for a specific fibrosis end-point. For FIB-4, the scores are interpreted as FIB-4 score of < 1.45: absence of cirrhosis, FIB-4 score of 1.45 to 3.25: inconclusive, FIB-4 score > 3.25: cirrhosis.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Units on a scale||Full Range|Median
143135|NCT00442572|Secondary|Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity|HBV DNA level, or viral load, is an indicator of viral replication. Higher HBV DNA levels are usually associated with an increased risk of liver disease and hepatocellular carcinoma. HBV DNA level typically falls in response to effective antiviral treatment.|Up to Week 108|Safety population included all randomized participants who passed during at least one treatment period and had at least one efficacy and safety evaluation. HBV DNA levels below lower limit for significant quantity were not studied for no intervention arm participants.||Percentage of Participants||95% Confidence Interval|Number
143136|NCT00442572|Secondary|Percentage of Participants With HBsAg Seroconversion|The development of antibodies against HBsAg is known as HBsAg seroconversion. It signifies clearance of HBsAg and resolution of the chronic infection. НBsAg seroconversion is the final goal of anti-hepatitis B virus treatment and it is closest to the definition of “cure” but in practice it is very rare in HBeAg-negative chronic hepatitis B (CHB).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis. Only participants with HBsAg clearance were analyzed.||Percentage of Participants|||Number
143137|NCT00442572|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Percentage of Participants||95% Confidence Interval|Number
143138|NCT00442572|Secondary|Percentage of Participants With Stable Virological and Biochemical Response|All participants who achieved virological response (serum HBV DNA < 20 000 copies/ml) and biochemical response (stable normalization of their alanine transaminase [ALT]) during the treatment cycle (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Percentage of Participants||95% Confidence Interval|Number
143139|NCT00442572|Primary|Percentage of Participants With Stable Virological Response|Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) <20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).|Up to Week 108|Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.||Percentage of Participants||95% Confidence Interval|Number
143140|NCT00442559|Secondary|Change From Baseline for Daily Allergic Rhinitis Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included.||Units on scale||Standard Deviation|Mean
143141|NCT00442559|Primary|Change From Baseline for Daytime Asthma Symptom Score|The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.|Baseline and Week 12|The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.||Units on scale||Standard Deviation|Mean
143142|NCT00442546|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Month 3, Month 6 (phone call)|MITT||scores on a scale||Standard Deviation|Mean
143143|NCT00442546|Secondary|Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)|"The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a no. Any positive score (1-10) of VRS was consider as yes."|Month 3, Month 6 (phone call)|MITT||participants|||Number
143144|NCT00442546|Secondary|Number of Subjects With Global Evaluation of Study Medication Scores|The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject’s overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent).|Discharge, Week 2, Week 4, and Week 6/ET|MITT||participants|||Number
143189|NCT00442468|Secondary|Number of Participants With the Indicated Experience With Tobacco Smoking||Day 1 of 1-day study|All participant respondents to the questions||participants|||Number
143147|NCT00442546|Secondary|Satisfaction With Medication Efficacy Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
143148|NCT00442546|Secondary|Satisfaction With Medication Characteristics Measured by the PTSS|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
143149|NCT00442546|Secondary|Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)|Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
143150|NCT00442546|Secondary|Time From End of Surgery to Actual Discharge|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT||hours||Standard Error|Mean
143151|NCT00442546|Secondary|Time From End of Surgery to Meet Hospital Discharge Criteria|The analysis was performed by Kaplan-Meier method with log-rank test.|time from end of surgery up to 192 hours post surgery|MITT||hours||Standard Error|Mean
143152|NCT00442546|Secondary|ROM Assessment of the Passive Flexion of the Surgical Knee|The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||degrees||Standard Error|Least Squares Mean
143153|NCT00442546|Secondary|Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee|The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer.|24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||degrees||Standard Error|Least Squares Mean
143154|NCT00442546|Secondary|Timed Up-and-Go (TUG)|TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 120 (Pregabalin 300 mg only), 144, 168, and 192 hours to calculate least squares mean values.||seconds||Standard Error|Least Squares Mean
143155|NCT00442546|Secondary|Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery|VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety.|Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery|MITT. There were not enough subjects with data at 6 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
143156|NCT00442546|Secondary|Pain-Related Sleep Interference Post Surgery|The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge.|24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
143157|NCT00442546|Secondary|Current Pain During the Hospital Stay Assessed by the Pain NRS|"Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question How much pain do you have right now? Scores range from 0 (no pain) to 10 (most possible pain)."|4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay|MITT. There were not enough subjects with data at 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
143158|NCT00442546|Secondary|Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS|Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
143159|NCT00442546|Secondary|Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)|Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge.|12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at 144, 168, and 192 hours to calculate least squares mean values.||scores on a scale||Standard Error|Least Squares Mean
143160|NCT00442546|Secondary|Pain Interference With Sleep as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to ‘how, during the past 24 hours, pain has interfered with your sleep’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143161|NCT00442546|Secondary|Pain Interference With Normal Work as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to ‘how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143162|NCT00442546|Secondary|Pain Interference With Walking Ability as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to ‘how, during the past 24 hours, pain has interfered with your walking ability’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143163|NCT00442546|Secondary|Pain Interference With Mood as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to ‘how, during the past 24 hours, pain has interfered with your mood’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143164|NCT00442546|Secondary|Pain Interference With General Activity as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to ‘how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143165|NCT00442546|Secondary|Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to ‘how, during the past 24 hours, pain has interfered with your enjoyment of life’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143166|NCT00442546|Secondary|Pain Interference With Relations With People as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to ‘how, during the past 24 hours, pain has interfered with your relations with other people’. Scale: 0 = does not interfere to 10 = completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143167|NCT00442546|Secondary|Pain Interference Index Score as Measured by the m-BPI-sf|m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes.|Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6|MITT||scores on a scale||Standard Error|Least Squares Mean
143168|NCT00442546|Secondary|Total Clinically Meaningful Event (CME) Score|CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
143169|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score|The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
143170|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score|The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
143171|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score|The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT||scores on a scale||Standard Error|Least Squares Mean
143172|NCT00442546|Secondary|The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score|The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent).|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET|MITT.||scores on a scale||Standard Error|Least Squares Mean
143190|NCT00442468|Secondary|Number of Participants Who Completed the Highest Indicated Education Level or Grade||Day 1 of 1-day study|All participant respondents to the questions||participants|||Number
143174|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET|Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 6/ET|MITT||mg||Standard Error|Least Squares Mean
143175|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|||mg||Standard Error|Least Squares Mean
143176|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4|Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 4|MITT||mg||Full Range|Median
143177|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 for Ibuprofen to calculate least squares mean values.||mg||Standard Error|Least Squares Mean
143178|NCT00442546|Secondary|Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT. There were not enough subjects with data at Week 2 and Week 4 for Ibuprofen to calculate least squares mean values.||mg||Standard Error|Least Squares Mean
143179|NCT00442546|Secondary|Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]|Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.|Week 2, Week 4, Week 6/ET|MITT.||mg||Standard Error|Least Squares Mean
143180|NCT00442546|Secondary|Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)|Total dose for in-hospital visits was the total dose for the day.|24 hours, 48 hours, 72 hours|MITT. There were not enough subjects with data to calculate least squares mean values at 24 and 48 hours for Acetylalicyclic Acid and 72 hours for Ketorolac.||mg||Standard Error|Least Squares Mean
143181|NCT00442546|Secondary|Opioids Used Post Discharge|The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid.|Week 2, Week 4, Week 6/Early Termination (ET)|MITT||mg of oral morphine equivalent||Standard Error|Least Squares Mean
143182|NCT00442546|Secondary|Cumulative Total Amount of Opioids Used During the Entire Hospital Stay|Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative.|24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours|MITT. There were not enough subjects with data at 168, 192, and 216 hours to calculate least squares mean values.||mg of oral morphine equivalent||Standard Error|Least Squares Mean
143183|NCT00442546|Primary|Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)|"The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an X in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block."|48 hours after surgery|Modified Intent-to-Treat (MITT) Population=all ITT subjects who took 12 and 2 hours pre-surgery study medications, had no surgical or anesthetic complications during total knee replacement surgery and had at least 1 post surgery primary efficacy measurement.||scores on a scale||Standard Error|Least Squares Mean
143184|NCT00442507|Secondary|Incidence and Severity of Toxicities|Grade 3 and higher toxicities using CTCAE Version 3.0.|Median follow-up time for toxicities 72 days (72 days-156 days)|Details of all SAEs and AEs are listed in the Serious Adverse Events and Other Adverse Events modules.||participants|||Number
143185|NCT00442507|Secondary|Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR)|"CR = disappearance of all target lesions~PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD."|Median follow-up for response 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.||participants|||Number
143186|NCT00442507|Secondary|Overall Survival Rate (OS)|OS is defined as the time from initiation of treatment to the date of death for any reason.|Median followup time from completion of treatment 325.5 days (44-401 days)|||months||95% Confidence Interval|Median
143187|NCT00442507|Primary|Time to Progression (TTP)|"TTP is defined as the time from initiation of treatment to the date of documented progression.~The median of TTP with 95% confidence interval will be presented.~Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.~Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions."|Median follow-up for TTP 6 weeks (6-18 weeks)|1 participant was not analyzed because the participant was removed from study during the first cycle due to an adverse event and was considered not evaluable for this outcome.||months||95% Confidence Interval|Median
143188|NCT00442468|Secondary|"Number of Participants Who Responded Yes When Asked Indicated Questions Regarding Medical History"|IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.|Day 1 of 1-day study|All participant respondents to the questions||participants|||Number
143193|NCT00442468|Secondary|Post-bronchodilator Reversibility Measures|To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases.|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry||participants|||Number
143194|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures|"Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre- and post-bronchodilator spirometry||percentage||Standard Deviation|Mean
143195|NCT00442468|Secondary|FEV1 and FVC, Post-bronchodilator Spirometry Measures|Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day visit|All participants who completed post-bronchodilator spirometry||Liters||Standard Deviation|Mean
143196|NCT00442468|Secondary|FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures|"Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight)."|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry||percentage||Standard Deviation|Mean
143197|NCT00442468|Secondary|FEV1 and FVC, Pre-bronchodilator Spirometry Measures|Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).|Day 1 of a 1-day study|All participants who completed pre-bronchodilator spirometry||Liters (L)||Standard Deviation|Mean
143198|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143199|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143200|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143201|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143202|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of to What Degree Does Pain Interfere With Normal Work, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143241|NCT00442013|Secondary|Asthma Symptom Utility Index (ASUI)|ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24|||score||95% Confidence Interval|Mean
143545|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Edema|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included||participants|||Number
143203|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143204|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143205|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143206|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143207|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143208|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143209|NCT00442468|Secondary|Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey|The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.|Day 1 of a 1-day study|All participant respondents to the question||participants|||Number
143210|NCT00442468|Secondary|Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire|The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).|Day 1 of 1-day study|All study participants who completed the questionnaire||participants|||Number
143211|NCT00442468|Secondary|Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale|The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing.|Day 1 of a 1-day study|All enrolled participants who completed the questionnaire||participants|||Number
143242|NCT00442013|Secondary|Rate of Episodes of Poor Asthma Control (EPAC)|"Episodes of poor asthma control are defined as any one of the following:~2 consecutive days with peak flow at less than 70% of baseline~prescription of oral corticosteroids for asthma~seeking urgent medical care for asthma symptoms~EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks"|Measured daily for 24 weeks by diary|The number of episodes of poor asthma control that occurred in each group over the 24-week follow-up period. Some participants experienced more than one EPAC over the course of follow-up||number of episodes of poor asthma contrl|||Number
143212|NCT00442468|Primary|Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%|Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC <=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD).|Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)|All enrolled participants who completed pre- and post-bronchodilator spirometry||participants|||Number
143213|NCT00442416|Secondary|Number of Participants With Any AEs, Any Serious Adverse Events and Death|An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.|Up to 9 months|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Participants|||Number
143214|NCT00442416|Secondary|Number of Participants With Anti-RO0503821 Antibody in Human Serum|RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were “BLQ” at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Participants|||Number
143215|NCT00442416|Secondary|Number of Participants With Anti-erythropoietin Antibody in Human Serum|Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were “below the limit of quantification (BLQ)” at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Participants|||Number
143216|NCT00442416|Secondary|Mean Change From Baseline in Weight||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||kilogram||Standard Deviation|Mean
143217|NCT00442416|Secondary|Mean Change From Baseline in Pulse Rate||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||Beats per minute||Standard Deviation|Mean
143218|NCT00442416|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||millimeter of mercury||Standard Deviation|Mean
143219|NCT00442416|Secondary|Mean Change From Baseline in Temperature||From Baseline (D 0) to D1 and D15 of M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||Degree Celsius||Standard Deviation|Mean
143220|NCT00442416|Secondary|Mean Change From Baseline in Total Iron-binding Capacity|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||mg per dL||Standard Deviation|Mean
143221|NCT00442416|Secondary|Mean Change From Baseline in Serum Transferrin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||milligram (mg) per dL||Standard Deviation|Mean
143222|NCT00442416|Secondary|Mean Change From Baseline in Transferrin Saturation|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||Percentage of Transferrin Saturation||Standard Deviation|Mean
143223|NCT00442416|Secondary|Mean Change From Baseline in Ferritin|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.|From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||microgram per litre||Standard Deviation|Mean
143224|NCT00442416|Secondary|Mean Change From Baseline in Iron|Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.|From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as 'n'.||micromole per litre||Standard Deviation|Mean
143225|NCT00442416|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment. Participants with available data at the time of evaluation were denoted as ‘n’.||Participants|||Number
143226|NCT00442416|Secondary|Percentage of Participants With Safety-Related Hb Measures|Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.|Up to Month 9|Safety population included all participants who received at least one dose of the study drug and had at least one post-baseline safety assessment.||Percentage of participants|||Number
143227|NCT00442416|Primary|Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period|Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.|From Baseline (D 0) to 9 months|Per-protocol population included all randomized participants who received at least one dose of the study drug and met all study entry criteria with no major protocol violations. Participants with available data at the time of evaluation were analyzed.||g/dL||Standard Deviation|Mean
143228|NCT00442364|Primary|Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects||28 day followup|||participants|||Number
143229|NCT00442351|Primary|Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements.|The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.|Twelve (12) weeks||||||
143230|NCT00442338|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration|The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.|Baseline and 60 minutes after study drug administration|Per Protocol Set (PPS): subset of participants who comply with the protocol sufficiently to ensure that these data will likely exhibit effects of treatment, according to the underlying scientific model. Aminophylline 250 mg - 1 participant with no FEV1 data at 60 minutes was excluded from the analysis.||Liter||95% Confidence Interval|Least Squares Mean
143231|NCT00442169|Primary|Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination.||Days 0 to 28 post-vaccination|Safety analysis was on all enrolled and vaccinated participants according to the vaccine actually received, safety population.||Participants|||Number
143232|NCT00442169|Primary|Number of Viremic Participants Post-vaccination|Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL|Day 21 post-vaccination|Viremia was assessed in all participants in the safety population according to the vaccine actually received.||Participants|||Number
143233|NCT00442169|Other Pre-specified|Number of Participants With Positive Immunoglobulin M (IgM) Response Post-vaccination in the As Treat Per-Protocol Population||Days 14 and 28 post-vaccination|Immunoglobulin M (IgM) response was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population||Participants|||Number
143234|NCT00442169|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination.||Days 0, 14, and 28 post-vaccination|Geometric mean titers were assessed according to the vaccine actually received, in the As treat per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
143235|NCT00442169|Primary|Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion).|Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples|Day 28 post-vaccination|Seroconversion was assessed in all participants in the safety population according to the vaccine actually received, As Treat Per-Protocol Population||Participants|||Number
143236|NCT00442117|Secondary|Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.|The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information. Two participants in the MF-DPI group and three participants in the BUD-DPI group were excluded from the analysis.||Percent Change of AM PEFR||Standard Deviation|Mean
143237|NCT00442117|Secondary|Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.|The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.||Percent Change of FEF||Standard Deviation|Mean
143238|NCT00442117|Secondary|Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.|The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.||Percent Change of FVC||Standard Deviation|Mean
143239|NCT00442117|Primary|Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.|FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.|Baseline and Week 12|Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.||Percent Change of FEV1||Standard Deviation|Mean
143240|NCT00442013|Secondary|Airways Reactivity (Assessed by Methacholine PC20)|Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds|Measured at Weeks 0 and 24|||mg/mL||95% Confidence Interval|Mean
143243|NCT00442013|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24|||Liters||95% Confidence Interval|Mean
143244|NCT00442013|Secondary|Asthma-specific Quality of Life|Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 16, 20, 24|||score||95% Confidence Interval|Mean
143245|NCT00442013|Primary|Change in Juniper Asthma Control Score (ACS)|Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points|Measured at Weeks 0, 4, 8, 12, 24|||score||95% Confidence Interval|Mean
143246|NCT00441974|Secondary|Number of Participants With ADV-associated Resistance at Week 48|Week 48 serum samples from participants, who reached a HBV DNA breakthrough or have HBV DNA≥5 log copies/mL at Weeks 24 and 48 were assessed for the development of ADV (Adefovir dipivoxil) mutation (N236T and A181V) in the HBV polymerase. Virologic breakthrough was defined as an increase in the level of HBV DNA 1 log10 copy/mL from Week 24 to Week 48. ADV-associated resistance was defined as participants with both virologic breakthrough and ADV mutation.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
143247|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Week 48|HBeAg loss and HBeAg seroconversion (HBeAg loss and HBeAb detected) were assessed in participants who were HBeAg positive at Weeks 0 and 48. Confirmed HBeAg loss was defined as undetectable HBeAg.|Week 48|Intent-to-Treat (ITT) Population: all HBeAg positive participants who actually received the study medication at least once||participants|||Number
143248|NCT00441974|Secondary|Number of Participants Achieving ALT (Alanine Aminotransferase) Normalization at Week 48|Elevated serum ALT levels are defined as serum ALT levels greater than the upper limit of the normal range (ULN), as determined using local laboratory ranges. ALT normalization was defined as ALT measurements at or below the ULN after a baseline value above the ULN.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
143249|NCT00441974|Secondary|Change From Screening in Median Serum HBV DNA at Weeks 24 and 48|The HBV DNA level was tested in blood serum by real-time Polymerase Chain Reaction with the LLD (lower limit of detection) as 300 copies/milliliter (cp/mL) at screening, week 24, and week 48 in a central laboratory. The change in HBV DNA from screening to week 24 and week 48 was conducted.|Weeks 24 and 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||log10 copies/milliliter||Full Range|Median
143250|NCT00441974|Secondary|Ranked Assessment of Liver Histology in HBeAg Positive Participants From Baseline to Week 48|A ranked assessment with the Knodell/HAI scoring system that represents the sum of scores for periportal bridging necrosis (0–10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0–4: none=0, marked=4); portal inflammation (0–4: none=0, marked=4) and fibrosis (0–4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two pathologists in the HBeAg positive participants who underwent liver biopsy at baseline and Week 48/withdrawal.|Baseline to Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48||points on a scale||Standard Deviation|Mean
143251|NCT00441974|Secondary|Number of HBeAg Positive Participants Achieving Histological Improvement at Week 48|Histological improvement (defined as a ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was accessed by two pathologists in HBeAg-positive participants undergoing liver biopsy at baseline and week 48/withdrawal. Knodell/Histological Activity Index (HAI) score = combined scores for necrosis, inflammation, and fibrosis and is the sum of scores for periportal bridging necrosis (0–10: none=0, multilobular necrosis=10), intralobular degeneration and focal necrosis and portal inflammation (0–4: none=0, marked=4), and fibrosis (0–4: none=0, cirrhosis=4).|Week 48|HBeAg positive chronic hepatitis B participants who underwent liver biopsy at Week 48||participants|||Number
143252|NCT00441974|Primary|Number of Participants Achieving HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) <1000 Copies/Milliliter at Week 48|HBV (Hepatitis B Virus) DNA level was tested by real-time Polymerase Chain Reaction at Week 48.|Week 48|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
143253|NCT00441792|Primary|Length of Stay|The primary outcome of the study was hospital length of stay.|time in days of hospitalization|All patients entering into the study were analyzed on an intent to treat basis.||days||Inter-Quartile Range|Median
143254|NCT00441792|Secondary|Mortality|In-hospital mortality.|Duration of hospitalization.|All patients entering into the study were analyzed on an intent to treat basis.||percentage of patients dying||95% Confidence Interval|Number
143255|NCT00441766|Secondary|Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)|Change from baseline in the frequency of bowel movements per day using the BSS. The BSS categorizes stool based on the patient's description of its consistency. Patients are classified into 3 IBS subtypes according to their predominant stool patterns (C=constipation; D=diarrhea; M=mixed). A positive change from baseline in the IBS-C indicates improvement and a negative change from baseline in the IBS-D and IBS-M indicates improvement.|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Bowel Movements (Stools) Per Day||Standard Deviation|Mean
143296|NCT00441480|Primary|LDL-C|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||md/dl||Standard Deviation|Mean
143256|NCT00441766|Secondary|Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4|"Percentage of patients who experienced AR-IBS at week 4. The AR-IBS is a self-evaluation by the patient of their perception of adequate relief of IBS pain over the last 7 days following treatment as compared to IBS pain before receiving treatment. Patients respond with either a Yes or No, where Yes indicated adequate relief of pain and No indicated no relief from pain."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Percentage of Patients|||Number
143257|NCT00441766|Secondary|Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4|"Percentage of patients who rated their condition as improved on the SGIC at week 4. The SGIC score was assessed using a 7-point scale (score of 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). Patients self-evaluated their overall change in symptoms (relief from symptoms of abdominal discomfort, pain, and altered bowel habits). An improved condition was defined as a score of 1, 2, or 3."|Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Percentage of Patients|||Number
143258|NCT00441766|Primary|Change From Baseline in Mean Highest-Average-Pain Score at Week 4|Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).|Baseline, Week 4|Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized), who received the study medication and had at least one post-baseline mean highest-average-pain score.||Scores on a Scale||Standard Deviation|Mean
143259|NCT00441727|Secondary|Number of Participants With Gastric and/or Duodenal Erosions.||The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|Patients randomized who had endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.||participants|||Number
143260|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.||participants|||Number
143261|NCT00441727|Secondary|Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.|RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.|RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.|Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.||participants|||Number
143262|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.|The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks|||percentage of participants|||Number
143263|NCT00441727|Secondary|Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.|The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks|||percentage of participants|||Number
143264|NCT00441727|Primary|Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).|The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.|During 26 weeks|||percentage of participants|||Number
143265|NCT00441701|Secondary|Part 2: Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Individual/Total Domains|SGRQ consists of 76 items aggregated into 3 domain scores: Symptoms (frequency/severity), Activity (cause or limited by breathlessness), Impact (social functioning, psychological disturbances from airway disease), and total score. Participants were to assess their symptoms, activity and impact at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for SGRQ. Part 2 of this study was not conducted under this protocol.|||||
143266|NCT00441701|Secondary|Part 2: Change From Baseline in Individual Symptom Scores|Participants were to be assessed for individual symptom scores at Baseline and Week 12 using the following scales: Sputum Production (0=none, unaware of any sputum production to 4=severe, an almost constant problem), Cough (0=none, unaware of coughing to 4=severe, never free of cough or need to cough), and Dyspnea (0=none, unaware of any difficulty to 4=severe, almost constant: present even when resting).|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 efficacy assessment for individual symptom scores. Part 2 of this study was not conducted under this protocol.|||||
143445|NCT00440947|Secondary|Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase|The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.|Baseline of Randomized Phase|ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase||years||Standard Deviation|Mean
143267|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Percent Neutrophil Count|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Part 2 of this study was not conducted under this protocol.|||||
143268|NCT00441701|Secondary|Part 2: Change From Baseline in Induced Sputum Absolute Neutrophil Count|Participants were to be assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count. Part 2 of this study was not conducted under this protocol.|||||
143269|NCT00441701|Secondary|Part 2: Change From Baseline in Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute via peak flow meter, is the maximum speed of expiration. Participants were to measure their PEF in triplicate every morning before taking study drug and again every evening.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for PEF. Part 2 of this study was not conducted under this protocol.|||||
143270|NCT00441701|Secondary|Part 2: Number of Participants Who Experience a COPD Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration of systemic corticosteroids, antibiotics, an emergency room visit or a hospitalization. The number of participants who experienced a COPD exacerbation was to be summarized.|Up to Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a at least one post-Baseline assessment for presence of COPD exacerbation. Part 2 of this study was not conducted under this protocol.|||||
143271|NCT00441701|Secondary|Part 2: Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters via body plethysmography, is the volume of air present in the lungs, specifically the parenchyma tissues, at the end of passive expiration. Participants were to be assessed for FRC at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FRC. Part 2 of this study was not conducted under this protocol.|||||
143272|NCT00441701|Secondary|Part 2: Change From Baseline in FVC|FVC, as measured in liters via spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for FVC. Part 2 of this study was not conducted under this protocol.|||||
143273|NCT00441701|Secondary|Part 2: Change From Baseline in Forced Expiratory Flow During Middle Half of Forced Vital Capacity (FVC) (FEF25%-75%)|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute via spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. Participants were to be assessed for FEF25%-75% at Baseline and Week 12.|Baseline and Week 12|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for FEF25%-75%. Part 2 of this study was not conducted under this protocol.|||||
143274|NCT00441701|Secondary|Part 2: Change From Baseline in Post-Bronchodilator FEV1|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after dosing with bronchodilator (albuterol sulfate or equivalent) (reversibility test) at Baseline and Week 12. Post-bronchodilator data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 efficacy assessment for post-bronchodilator FEV1. Part 2 of this study was not conducted under this protocol.|||||
143275|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Percent Neutrophil Count (Induced Sputum)|Sputum neutrophils were to be measured as percent of total white blood cells. Participants were to be assessed for induced sputum percent neutrophil counts via the nebulized method at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least 1 dose of study drug, and had a Baseline and Week 12 assessment for sputum percent neutrophil count. Since sufficient data for analysis were collected for absolute sputum neutrophil count, percent sputum neutrophil count was not assessed.|||||
143276|NCT00441701|Secondary|Part 1: Change From Baseline in Sputum Absolute Neutrophil Count (Induced Sputum)|Participants were assessed for induced sputum absolute neutrophil counts via the nebulized method at Baseline and at Week 12. The reported SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and Week 12 assessment for induced sputum absolute neutrophil count.||10^9 cells/L||Standard Deviation|Mean
143277|NCT00441701|Secondary|Part 1: Change From Baseline in Percent PBN Count|Participants were to be assessed for percent PBN counts at Baseline and at Week 12.|Baseline and Week 12|The population was to consist of all Part 1 participants who were randomized, received at least one dose of study drug, and had a Baseline and a Week 12 assessment for percent PBN count. Since sufficient data for analysis were collected for absolute PBN count, percent PBN count was not assessed.|||||
143278|NCT00441701|Primary|Part 2: Change From Baseline in Daily Morning/Nighttime Sputum Production, Cough, and Dyspnea (SCDS) Score|Participants were to assess their morning (AM) and nighttime (PM) COPD symptoms (sputum production, cough, and dyspnea) on a daily basis in their e-Diaries. Baseline SCDS was defined as the average of AM and PM values over the week prior to and including Day 1 (AM) prior to the first dose of study drug. SCDS data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for AM/PM SCDS scores. Part 2 of this study was not conducted under this protocol.|||||
143279|NCT00441701|Primary|Part 2: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1, as measured in liters via spirometry, is a measure of the amount of air expired in 1 second. Participants were to be assessed for pre-bronchodilator FEV1 immediately before dosing with bronchodilator (albuterol sulfate or equivalent) at Baseline and at Week 12. Pre-bronchodilator FEV1 data were to be averaged weekly over the 12-week treatment period for analysis.|Baseline and the Average over 12 weeks|The population was to consist of all Part 2 participants who were randomized, received at least one dose of study drug, and had a Baseline and at least one post-Baseline assessment for FEV1. Part 2 of this study was not conducted under this protocol.|||||
143280|NCT00441701|Primary|Part 1: Change From Baseline in Absolute Peripheral Blood Neutrophil (PBN) Count|Participants were assessed for absolute PBN counts at Baseline and Week 12. The reported standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline and Week 12|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug and had a Baseline and a Week 12 assessment for absolute PBN count.||10^9 cells/L||Standard Deviation|Mean
143281|NCT00441701|Primary|Part 1: Number of Participants Who Discontinue Study Drug Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.||Participants|||Number
143282|NCT00441701|Primary|Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to 12 weeks|The population consisted of all Part 1 participants who were randomized and received at least one dose of study drug.||Participants|||Number
143283|NCT00441584|Primary|Number of Subjects Who Have Achieved Sustained Virological Response (SVR) at 24 Weeks Post End of Treatment|Sustained virologic response is defined as a plasma HCV RNA level below Lower Level of Quantitation at 24 weeks post-treatment, which is < 30 IU/mL in this study.|Up to 48 weeks of treatment plus 24 weeks follow up|The All Treated population included all subjects who took at least one dose of study medication.||Participants|||Number
143284|NCT00441558|Primary|The Frequency of Adverse Events (Side Effects).|This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder|52 weeks|||participants with any adverse event|||Number
143285|NCT00441545|Secondary|Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks|Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)|4 weeks|||Percentage of Participants|||Number
143286|NCT00441545|Secondary|Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks||Baseline and 4 weeks|ITT||pg/mL||Standard Error|Mean
143287|NCT00441545|Secondary|Change From Baseline in Serum Calcium Levels at 4 Weeks||4 weeks|ITT||mg/dL||Standard Error|Least Squares Mean
143288|NCT00441545|Primary|Change From Baseline in Serum Phosphorus Levels at 4 Weeks||4 weeks|ITT population defined as subjects who were randomized, received at least one dose of investigational product, and had at least one post-dose assessment of the primary efficacy variable.||mg/dL||Standard Error|Least Squares Mean
143289|NCT00441480|Secondary|Apolipoprotein A|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143290|NCT00441480|Secondary|Apolipoprotein A|Blood test on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143291|NCT00441480|Secondary|Apolipoprotein B100|Blood test results follwing 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143292|NCT00441480|Secondary|Apolipoprotein B100|Blood test results on day 0|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143293|NCT00441480|Secondary|CRP|Blood test results following 12 weeks of intervention of High sensetivity C reactive protein|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/l||Standard Deviation|Mean
143294|NCT00441480|Secondary|CRP|Blood test results on day 0 of High sensitivity C Reactive Protein|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/l||Standard Deviation|Mean
143295|NCT00441480|Secondary|HDL-cholestrol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143297|NCT00441480|Secondary|HDL Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143298|NCT00441480|Secondary|Total Cholesterol|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143299|NCT00441480|Secondary|Total Cholesterol|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143300|NCT00441480|Secondary|Triglycerides|Blood test results following 12 weeks of intervention|12 weeks|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143301|NCT00441480|Secondary|Triglycerides|Average of blood test results at -10 and 0 weeks (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143302|NCT00441480|Primary|LDL Cholesterol|Average of blood test results at -10 and 0 days (before and after run-in period)|at baseline|Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points||mg/dl||Standard Deviation|Mean
143303|NCT00441467|Secondary|Overall Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.|||months||95% Confidence Interval|Median
143304|NCT00441467|Secondary|Progression-free Survival||All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.|||months||95% Confidence Interval|Median
143305|NCT00441467|Primary|Objective Response Rate|The event rate was the response rate (complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). The associated 95% exact binomial confidence intervals were calculated.|Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.|Patients receiving glufosfamide with a post treatment imaging assessment||participants|||Number
143306|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline: Week 12 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value,nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population||ratio|||Number
143307|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanomoles per 24 hr (nmoles/24 hr)||Full Range|Geometric Mean
143308|NCT00441441|Post-Hoc|Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nmol/24 hrs. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs) .|Baseline and Week 12|Cortisol Population||ratio|||Number
143309|NCT00441441|Post-Hoc|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|A post-hoc analysis excluding participants with urine cortisol baseline values of >200 nanomoles/24 hours. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanamoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
143310|NCT00441441|Secondary|Percent of Albuterol-free Days|Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.||Percentage of days||Standard Error|Mean
143311|NCT00441441|Secondary|Albuterol Use|Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 168 and 174 at baseline; 166 and 172 at Weeks 1-12; and 157 and 165 for the last 7 days on treatment.||Number of puffs per 24 hours||Standard Error|Mean
143513|NCT00440232|Secondary|Time to Development of Headache of Any Intensity|Time to development of headache of any intensity in the 2 treatment arms|20 hours|||hours||95% Confidence Interval|Mean
143312|NCT00441441|Secondary|Percentage of Symptom Free Days|Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent .|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.||Percentage of days||Standard Error|Mean
143313|NCT00441441|Secondary|Asthma Symptom Scores|Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent.|Baseline and 12-Week Treatment Period|Participants from the ITT population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 172 and 174 at Weeks 1-12; and 167 and 170 for the last 7 days on treatment.||Score in scale||Standard Error|Mean
143314|NCT00441441|Secondary|AM Peak Expiratory Flow|The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded.|Baseline and 12-Week Treatment Period|Participants from the ITT Population (not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 173 and 175 at baseline; 173 and 174 at Weeks 1-12; and 171 and 173 for the last 7 days on treatment.||Liters/minute (L/min)||Standard Error|Mean
143315|NCT00441441|Secondary|Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years|"FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining best effort from 3 to 8 measurements. Week 12 is the measure taken at Week 12."|Baseline and week 12|Subset of ITT Population: Participants who were 6-11 years of age (population not necessarily selected to show efficacy differences). Total numbers of participants analyzed for the Fluticasone propionate (FP)/salmeterol HFA and FP groups, respectively, were 137 and 136 at baseline; 126 and 124 at Week 12, and 6 and 7 at premature discontinuation.||Liters per second (L/sec)||Standard Error|Mean
143316|NCT00441441|Primary|Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population||ratio|||Number
143317|NCT00441441|Primary|Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12|AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
143318|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use|"AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and Week 12|Cortisol Population||participants|||Number
143319|NCT00441441|Primary|Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion|Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).|Baseline and Week 12|Cortisol Population||ratio|||Number
143320|NCT00441441|Primary|Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12|Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.|Baseline and Week 12|Cortisol Population||Nanomoles per 24 hours (nmol/24 hrs)||Full Range|Geometric Mean
143321|NCT00441441|Primary|Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion|"Abnormal high cortisol excretion and Abnormal low cortisol excretion are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory."|Baseline and week 12|Cortisol Population - all participants not excluded due to the following reasons: missing data, use of protocol-specified corticosteroids (prior to screening), collection time outside of 24 ± 2 hours, use of inhaled cortical steroid (ICS) during treatment, and who stopped study medication >1 day prior to start of post-baseline urine collection.||participants|||Number
143363|NCT00441272|Primary|Hepatic Steatosis|Evaluation of the safety and potential benefits of pioglitazone therapy on hepatic steatosis in HIV-infected men and women.|96 weeks|A total of 11 subjects enrolled into the study. 10 were determined to be ineligible during the screening as the Computerized tomography scan revealed a liver-to-spleen ratio > 1 and one was determined ineligible due to concomitant medication use.||Hounsfeld units||Standard Deviation|Mean
143514|NCT00440232|Primary|Incidence of Fasting-induced Headache of Any Intensity|Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting|20 hours|||participants|||Number
143322|NCT00441441|Primary|Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols|The Primary Investigator determined the severity of the exacerbation based on the participant’s clinical presentation and the investigator’s understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful.|Treatment period (weeks 1-12)|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
143323|NCT00441441|Primary|Cardiovascular Adverse Events Reported During the Post-Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.|5 Days after Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
143324|NCT00441441|Primary|Cardiovascular Adverse Events Reported During Treatment Period|Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.|12-Week Treatment Period|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
143325|NCT00441441|Primary|ECG Measures - QT Interval|Fridericia’s formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett’s formula QTc=QT/squared root of the R-R interval.|Baseline and Week 12|ITT Population - All participants who were randomized and received at least one dose of double-blind study treatment.||milliseconds||Full Range|Mean
143326|NCT00441441|Primary|ECG Measures – Heart Rate|The range of heart rates for this study was between 49-144 beats per minute|Baseline and Week 12|ITT Population - All subjects who were randomized and received at least one dose of double-blind study treatment.||beats per minute||Full Range|Mean
143327|NCT00441441|Primary|Clinically Significant Unfavorable ECGs at Week 12|Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator.|Baseline, Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The numbers of participants at Week 12 were 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.||participants|||Number
143328|NCT00441441|Primary|Investigator Evaluations of Electrocardiogram (ECG) Results|ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants’ history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation.|Baseline and Week 12|ITT Population. The number of participants at baseline was 173 and 177, respectively, for the Fluticasone propionate/salmeterol HFA and Fluticasone Propionate (FP) HFA groups. The number of participants at Week 12 was 162 and 160, respectively. Data for 6 participants in the FP treatment arm were either not obtained or not evaluable.||participants|||Number
143329|NCT00441441|Primary|Possible Drug-Related Adverse Events|Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.|Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)|Intent-to-Treat (IITT) Population - All participants who were randomized and received at least one dose of double-blind study treatment.||participants|||Number
143330|NCT00441363|Secondary|Number of Serious Adverse Events Experienced by the Subjects||up to 24 weeks|Report of Serious adverse events that occurred in the trial.||serious adverse events|||Number
143331|NCT00441363|Secondary|Fasting Plasma Glucose and Lipids||up to 24 weeks||||||
143332|NCT00441363|Primary|Change in Baseline to End of Study in HbA1c|Too few subjects were enrolled to assess outcome to pre-specified statistical power.|up to 24 weeks|||% HbA1c||Standard Deviation|Mean
143333|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBPs on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
143546|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included||participants|||Number
143334|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
143335|NCT00441337|Secondary|Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean SBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
143336|NCT00441337|Secondary|Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population|Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 minutes post infusion, and at 1, 2, 3, 4, 6, 8 hours post infusion. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. Mean DBP on Day 1 for first dose (cycle 1) are presented below.|Baseline, Day 1|All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.||mmHg||Standard Deviation|Mean
143337|NCT00441337|Secondary|Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population|12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).|Baseline, Day 2, Day 85, Day 113|All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.||msec||Standard Deviation|Mean
143338|NCT00441337|Secondary|Mean Change From Baseline in PSA Relative Velocity at Days 29, 57, and 85 With Cycle 1 in PSA Evaluable Population|PSA relative velocity (PSA RV) was defined as = (d[PSA]/dt)/ [PSA], where [PSA] =concentration of PSA, and t= time, and in the limit reflects the instantaneous change in PSA levels as a fraction of total PSA level. Decreases in PSA RV may occur while measured [PSA] is still rising, and may indicate that continued therapy may lead to a treatment benefit, particularly in the setting of immunotherapy, where expansion of an effective immune response is likely to require weeks to mature. Baseline PSA RV was based on the velocity of last PSA measurement before the first infusion of study drug and the screening PSA measurement.|Day 29, Day 57, Day 85|The PSA evaluable population includes all participants in the study who received complete dose(s) of nivolumab and has a baseline PSA assessment and at least 1 post-baseline PSA assessment.||percentage of total PSA level||Full Range|Median
143339|NCT00441337|Secondary|Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population|Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method.|Day 1 to 2 Years|The PSA evaluable population include all participants in the study who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least 1 post-baseline PSA assessment.||days||95% Confidence Interval|Median
143340|NCT00441337|Secondary|Time to Tumor Progression and Tumor Progression Free Survival|Time to tumor progression (TTP) was measured in days from date of the first dose to the date of the first PD or the date of death if due to PD. For those who died without PD it was censored at the date of death. TTP was censored at the last tumor assessment by the end of study if a participant did not have PD or death. Tumor progression free survival (PFS) was measured in days from the date of first dose to the date of the first disease progression or to the date of death. PFS was censored at the last tumor assessment date by the end of study if a participant did not have PD or death.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||days||95% Confidence Interval|Median
143341|NCT00441337|Secondary|Median Time to Tumor Response and Duration of Tumor Response|Time to tumor response: from the date of first dose to the first date of tumor response (CR or PR confirmed at least 4 weeks later); for nonresponders, it was censored at the date of the maximum tumor assessment time in the dose cohort by the end of study. Duration of tumor response was calculated from the first date of response of CR or PR to the date of the first PD or the date of death if a participant died due to disease progression (whichever occurred first). Duration of response was censored at the last tumor assessment date by the end of study if a responder did not have PD or death. Nonresponders had the duration of response as an event of 0 days.|Day 1 to 2 Years|All participants who received at least 1 dose or any partial dose of nivolumab and were tumor responders were analyze.||days||95% Confidence Interval|Median
143342|NCT00441337|Secondary|Percentage of Participants With Disease Control and Major Durable Disease Control|Disease control rate was defined as number of participants whose Best Overall Response (BOR) was complete response (CR), partial response (PR), or stable disease (SD) divided by the total number of participants. Major durable disease control rate was defined as the total number of participants whose BOR was CR, PR, or SD ≥24 weeks, divided by the total number of participants. Per RECIST v 1.0, BOR for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter since treatment; SD=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for PD. PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. 95% CIs were computed using the Clopper and Pearson method.|Day 1 to 2 Years|Safety Population was analyzed: All participants who received at least 1 dose or any partial dose of nivolumab.||percentage of participants||95% Confidence Interval|Number
143343|NCT00441337|Secondary|Number of Participants With Best Overall Response (BOR) by Category in Safety Population|Measurable and non-measurable disease/target lesions were evaluated according to National Cancer Institute standardized RECIST.Complete Response (CR)=disappearance of all target and non-target lesions and no new lesions; Partial Response=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; Stable disease (SD)=neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since treatment; PD=at least a 20% increase in the sum of the longest diameter recorded since screening, or the appearance of one or more new lesions. BOR was recorded between the first tumor assessment and last tumor assessment. CR and PR had to be confirmed by repeat assessment no less than 4 weeks after the criteria were first met. SD assessment must have met the criteria at least once at or after Week 12.|Day 1 to Day 85|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||participants|||Number
143344|NCT00441337|Primary|Percent of Participants With Prostate-Specific Antigen (PSA) Response After the First Dose by Day 85 In Participants With Hormone-Refractory Prostate Adenocarcinoma (HRPC)|The PSA response rate was defined as the number of participants who had at least a 50% decrease of the PSA value from the PSA reference value divided by the total number of participants evaluated (percent of participants). PSA reference value was the PSA concentration measured immediately prior to dosing on Day 1. PSA response was assessed using the Recommendations from the National Cancer Institute Prostate-Specific Antigen Working Group. A PSA response had to be confirmed at least 4 weeks after first response. 95% exact CIs were computed using the Clopper and Pearson method.|Day 1 to Day 85|The PSA evaluable population was analyzed and included all HRPC participants who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least one post baseline PSA assessment. A PSA evaluable participant could not have any major inclusion/exclusion violation, dosing violation, or protocol conduct violation.||percentage of participants||95% Confidence Interval|Number
143345|NCT00441337|Primary|Percent of Participants With Best Overall Response Rate in Safety Population and in Tumor Evaluable Population|The Best Overall Response Rate (BORR) was defined as the number of participants who had a confirmed complete response (CR) or partial response (PR) during the study divided by the total number of participants evaluated. Response was based on tumor assessment for both target and non-target lesions using: Clinical examination; Chest X-ray; Computed Tomography and Magnetic Resonance Imaging; Bone scan; Ultrasound. Per National Cancer Institute Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, best overall response (BOR) for tumors was confirmed CR or PR. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. Confidence intervals (CIs) were computed using the Clopper and Pearson method.|Day 1 up to 2 Years.|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed. Tumor Evaluable Population: all participants who received complete dose(s) of nivolumab and had completed a major tumor assessment (a baseline and at least 1 post-baseline tumor assessment for either target and/or non-target assessments.||percentage of participants||95% Confidence Interval|Number
143346|NCT00441337|Primary|Mean Volume of Distribution (Vz) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Vz was measured in milliliters per kilogram of body weight (mL/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||mL/kg||Standard Deviation|Mean
143347|NCT00441337|Primary|Geometric Mean Total Body Clearance of Drug From Serum (CLT) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of CLT was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
143348|NCT00441337|Primary|Mean Elimination Half-life (T-HALF) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of T-HALF was measured in days.|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||days||Standard Deviation|Mean
152550|NCT00364949|Primary|Testosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/dl||Standard Deviation|Mean
143349|NCT00441337|Primary|Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose|AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms*hours per milliliter (µg*h/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
143350|NCT00441337|Primary|Median Time at Which the Maximum Serum Concentration Occurred (Tmax) Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameter of Tmax was measured in hours (h).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||h||Full Range|Median
143351|NCT00441337|Primary|Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose|Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|Day 1 to Day 85|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
143352|NCT00441337|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Drug-Related AEs, Deaths, Discontinuation of Study Drug Due to AE, Dose-Limiting Toxicity (DLT) AE and Immune-related AEs (irAEs) in Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Severe=All Grade 3 or 4 events. Death=during the study and up to 28 days past study discontinuation. AEs graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. irAEs=unknown etiology, associated with study drug and consistent with an immune phenomenon. DLT: ≥Gr 3 AE(s) or lab abnormality without alternative explanation other than drug.|Day 1 to 70 days post last dose of study drug; 28 days past study discontinuation|Safety Population: All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.||participants|||Number
143353|NCT00441285|Secondary|Phase III Trial - Seizure Frequency|Seizure frequency by treatment group|Day 1 - 540|Final population numbers for this analysis not yet defined|||||
143354|NCT00441285|Primary|Phase III Trial - Proportion of Patients Without Remaining Live Cysts|Proportion of patients whose 6 month MR does not show viable parasites anymore|Day 180|Some patients did not reach the analysis time point.||participants|||Number
143355|NCT00441285|Secondary|Phase III Trial - Proportion of Cysts Which Resolved|Proportion of Viable Brain Parasites which Are not Alive Anymore at 6 Months MRI|Day 180|Final population numbers for this analysis not yet defined|||||
143356|NCT00441285|Secondary|PK Substudy - Safety of Combined Albendazole Plus Praziquantel Therapy|- Describe if some Serious Adverse Event was associated to combined Albendazole plus Praziquantel therapy.|90 days post tx|||Events|||Number
143357|NCT00441285|Primary|PK Substudy - Maximum Concentration of Albendazole|Highest serum level of Albendazole measured from all level assessments in the curve.|Treatment day 1 and Treatment days 10-11|||ng/mL||Standard Deviation|Mean
143358|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Days 10 and 11|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on treatment days 10-11|||ng*h/ml||95% Confidence Interval|Mean
143359|NCT00441285|Secondary|PK Substudy - Area Under the Curve of Praziquantel by Antiepileptic Drug in Treatment Day 1|- To evaluate the kinetic disposition of Praziquantel by antiepileptic drug after the last praziquantel dose, we calculated the Area Under the Curve of Praziquantel with Carbamazepine or Phenytoin|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose in treatment day 1|Carbamazepine and Phenytoin were not assigned by the study.||ng*h / mL||Standard Deviation|Mean
143360|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment Days 10 and 11|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0.5, 1, 1.5, 2, 3, 4, 8, 10, 12, 24 and 36 hours post dose on Treatment days 10-11|||ng*h/ml||95% Confidence Interval|Mean
143361|NCT00441285|Primary|PK Substudy - Area Under the Curve of Albendazole in Treatment in Day 1|- To evaluate kinetic disposition of Albendazole we calculated the Area under the curve of the active metabolite of Albendazole (Albendazole Sulphoxide) with Praziquantel or Placebo (of Praziquantel).|0, 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 12 hours post dose on Treatment day 1|||ng*h/mL||95% Confidence Interval|Mean
143362|NCT00441272|Secondary|Insulin Resistance||48 weeks||||||
152551|NCT00364949|Primary|Androstenedione Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/dl||Standard Deviation|Mean
143364|NCT00441259|Secondary|Geometric Mean Titers (GMTs) Using Neutralizing Antibody to Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post-vaccination|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
143365|NCT00441259|Secondary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post Dose 1|Seroprotection was assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.||Participants|||Number
143366|NCT00441259|Primary|Geometric Mean Titers (GMTs) of Japanese Encephalitis Viruses After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type).|Day 42 Post Dose 1|Geometric Mean Titers were assessed in participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination blood samples (Day 42) for antibody analysis, per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
143367|NCT00441259|Primary|Number of Participants With Seroconversion After Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine|Antibodies to Japanese encephalitis (JE) virus were measured with 50% plaque reduction neutralization tests (PRNT50) using JE CV virus, JE virus Nakayama strain, and JE virus strain 826309 (Indian wild-type). Seroconversion was defined as a titer ≥10 1/dil for participants who were seronegative at baseline and ≥ 4 fold rise for participants who were seropositive at baseline (titer ≥ 10 1/dil).|Day 42 Post-vaccination|Seroconversion was assessed all participants who received all doses of the investigational product in the Treatment Period, had Baseline and post-vaccination samples (Day 42) for antibody analysis, per-protocol population.||Participants|||Number
143368|NCT00441259|Primary|Number of Participants With Treatment-Related Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed all enrolled and vaccinated participants, intent-to-treat (safety) population.||Participants|||Number
143369|NCT00441259|Primary|Number of Participants With Treatment Emergent Adverse Events Following Vaccination With Either ChimeriVax™ JE or JE Inactivated Mouse Brain Derived Vaccine||Day 14 up to Day 42 Post-vaccination|Adverse events were assessed in all enrolled participants, intent-to-treat (safety) population.||Participants|||Number
143370|NCT00441168|Secondary|Duration of Response (DOR)|DOR was defined as the duration from the date of the best confirmed response for subjects who achieved CR or PR to the date of first documented evidence of PD (or relapse for subjects who experienced CR) over the duration of the study. DOR = ([Date of PD or date of censoring – Date of best response]+1)/30.44.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.There was insufficient data to perform Kaplan Meier analysis (data available for 5 subjects in the VAD group and 6 subjects in the PAD group).||months|||Number
143371|NCT00441168|Primary|Best Reported Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the EBMT criteria as assessed by the investigator. The ordering of the responses was: CR, PR, MR, NC and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.||participants|||Number
143372|NCT00441168|Primary|Best Confirmed Disease Response|The primary efficacy analysis was based on the best response obtained during the treatment period according to the European Group for Blood and Marrow Transplantation (EBMT) criteria as assessed by the investigator. The best confirmed response was defined as 2 separate and consecutive evaluations of response, at least 6 weeks apart (for progressive disease [PD], 1 to 3 weeks apart). The ordering of the responses was: complete response (CR), partial response (PR), minimal response (MR), no change (NC) and PD. CR was the best response and the poorest response was PD.|every 28 days during treatment period for up to 6 to 8 cycles|Subjects in the ITT population (all subjects who received at least one dose of study drug and who had at least one post baseline efficacy parameter) were included.||participants|||Number
143373|NCT00441142|Secondary|PHASE I: To Define the Safety of ZD6474 (Vandetanib) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in This Population.||2 years||||||
143374|NCT00441142|Secondary|PHASE II: To Further Evaluate the Safety Profile of ZD6474 (Vandetanib) in Combination With Radiation Therapy and Temozolomide in This Patient Population.||3 years||||||
143375|NCT00441142|Secondary|Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free|A secondary outcome of Phase II of this trial is the median progression-free survival (PFS), as calculated by the # of months patients remain progression-free|3 years|||months||95% Confidence Interval|Median
143376|NCT00441142|Primary|Median Overall Survival (OS) of Phase II Patients|The primary outcome of Phase II of this trial was to determine the efficacy of ZD6474 (Vandetanib) in combination with radiation therapy and concomitant and adjuvant temozolomide in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival and median survival.|3 years|This measure was only assessed in Participants in Phase II part of the study, who had available data for analysis||months||95% Confidence Interval|Median
143547|NCT00439946|Secondary|Change From Baseline at Week 8 in Symptoms of PAH- Fatigue|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
143377|NCT00441142|Primary|Number of Participants That Experienced a Dose-limiting Toxicity (DLT)|The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.|2 years|This measure was only assessed in Participants enrolled into the Phase I part of the study who had available data for analysis.||Participants|||Number
143378|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143379|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143380|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143381|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143382|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143383|NCT00441116|Secondary|Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive|"In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, No Problem shift to No Problem indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively."|Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143384|NCT00441116|Secondary|Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143385|NCT00441116|Secondary|Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143386|NCT00441116|Secondary|Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143387|NCT00441116|Secondary|Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Baseline|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143388|NCT00441116|Secondary|Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation|In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?|Screening|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143389|NCT00441116|Secondary|Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.|Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)|Baseline and Month 6|Intent to Treat(ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||mg/dL||Standard Deviation|Mean
143936|NCT00436644|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression, with patients who are progression free being censored on the date of their last evaluation.|Time from registration to progression (up to 2 years)|||months||95% Confidence Interval|Median
143390|NCT00441116|Secondary|Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.|sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||IU/L||Standard Deviation|Mean
143391|NCT00441116|Secondary|Laboratory Values: Hematology Assessed at Baseline and 6 Months.|Comparing Lab values and differences from Baseline to month 6|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||thousands/microliter||Standard Deviation|Mean
143392|NCT00441116|Secondary|Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.|Sodium, Potassium (mEq/L), and Bicarbonate|Baseline and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||mmol/L||Standard Deviation|Mean
143393|NCT00441116|Secondary|Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10.|Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L.|Baseline to Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. LH was only assessed at baseline.||Participants|||Number
143394|NCT00441116|Secondary|The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10|Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.|Month 3, Month 6, and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Percent change||Standard Deviation|Mean
143395|NCT00441116|Secondary|The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10|Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.|Month 3, Month 6 and Month 10|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Percent change||Standard Deviation|Mean
143396|NCT00441116|Secondary|Panel Assessment of Improvement Distribution From Screening|"Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count.~Score Range -3=greatly decreased to +3=greatly increased. 0=No change."|Baseline to Month 3 and Baseline to Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143397|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvements From Baseline Score|Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.|Month 3 and Month 6|Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator.||units on a scale||Standard Deviation|Mean
143398|NCT00441116|Secondary|Investigator's Photographic Assessment of Improvement Distribution From Baseline|Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143399|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143400|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143401|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143402|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?|GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143433|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 144|Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a viral load result obtained during that visit period.||log10 c/ml||Standard Deviation|Mean
143403|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143404|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.||Participants|||Number
143405|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143406|NCT00441116|Secondary|Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?|GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.|Month 3 and Month 6|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||Participants|||Number
143407|NCT00441116|Secondary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and Month 3|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||hair count per centimeters squared||Standard Deviation|Mean
143408|NCT00441116|Primary|Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.|The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.|Baseline and 6 months|Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.||hair count per centimeters squared||Standard Deviation|Mean
143409|NCT00441103|Secondary|Number of CU Active MRI Lesions|CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting).|Up to Week 40|ITT population included all randomized participants who received at least one dose of study drug.||lesions||Standard Deviation|Mean
143410|NCT00441103|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. AEs were categorized based upon the treatment period during which they occurred, that is, double-blind period (up to Week 16) and rater-blind period (Week 17 up to Week 40).|Baseline up to Week 40|Safety population included all randomized participants who received at least one dose of study drug. Here, 'n' signifies those participants who were evaluable for the specified category.||participants|||Number
143411|NCT00441103|Secondary|Mean Number of CU Lesions Per Scan Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Participants, Originally Randomized to Placebo.|"CU active lesions were defined as a unique newly active or persistently active lesion on the PD/T2 scan or the gadolinium enhanced T1 scan (with a method to avoid double counting). Only Placebo Followed by RNF arm was evaluable for this outcome measure."|Day 1 up to Week 16 and Week 17 up to Week 40|"ITT population included all randomized participants who received at least one dose of study drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."||lesions||Standard Deviation|Mean
143412|NCT00441103|Primary|Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16|CU active lesions were defined as a unique newly active or persistently active lesion on the protocol density/time constant 2 (PD/T2) scan or the gadolinium (Gd-) enhanced time constant 1 (T1) scan (with a method to avoid double counting).|16 Weeks|ITT population included all randomized participants who received at least one dose of study drug.||lesions||Standard Deviation|Mean
143413|NCT00441064|Secondary|Percentage of Responders Defined as MASBP <130 mm Hg or a Decrease From Baseline in MASBP of ≥20 mm Hg in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the percentage of responders defined as MASBP < 130 mm Hg or a decrease in MASBP from baseline of ≥20 mm Hg in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and Week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets||Percentage of responders|||Number
143632|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 at 7 Months After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 7 months after receipt of the first dose of vaccine.|Approximately Day 208|||Participants|||Number
143414|NCT00441064|Secondary|Mean 24 Hour Ambulatory Diastolic Blood Pressure (MADBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|To evaluate the mean 24 hour ambulatory diastolic blood pressure (MADBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets||mm Hg||Standard Deviation|Mean
143415|NCT00441064|Primary|Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet|The primary objective of the study was to assess mean 24 hour ambulatory systolic blood pressure (MASBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]|Week 4 and week 8 (4 weeks after crossover)|Completers Population: Included all patients who completed both diet periods - high and low sodium diets||mm Hg||Standard Deviation|Mean
143416|NCT00441012|Secondary|The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||µg /mL||95% Confidence Interval|Geometric Mean
143417|NCT00441012|Secondary|The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.|"The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after~the third dose)"|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
143418|NCT00441012|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)|0-11 months (recorded from first dose until the participant completes or discontinues)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
143419|NCT00441012|Primary|The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.|Geometric Mean Titer (GMT) – This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
143420|NCT00441012|Primary|The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)|11 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
143421|NCT00440947|Secondary|Mean Percent Compliance at Week 144|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 144|ITT-Extension Population, Extension Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.||percent compliance||Standard Deviation|Mean
143422|NCT00440947|Secondary|Mean Percent Compliance at Week 84|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 84|ITT-E Population, Randomized Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.||percent compliance||Standard Deviation|Mean
143423|NCT00440947|Secondary|Mean Percent Compliance at Week 36|Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.|Week 36|ITT-E Population, Induction Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.||percent compliance||Standard Deviation|Mean
143424|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations||participants|||Number
143425|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Randomization at Week 36 through Week 84|Participants in the ITT-E population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
143426|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
143427|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Week 84 through Week 144|Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.||participants|||Number
143428|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Randomization at Week 36 through Week 84|Participants in the ITT-E Population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
143429|NCT00440947|Secondary|Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline through Week 36|Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.||participants|||Number
143430|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 144|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 144|ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a cell count obtained during that visit period.||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
143431|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 84|A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a cell count obtained during that visit period.||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
143432|NCT00440947|Secondary|Change From Baseline in CD4+ Cell Count at Week 36|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 36 visit and had a cell count obtained during that visit period.||cells/millimeters cubed (mm^3)||Standard Deviation|Mean
143633|NCT00439335|Secondary|HAI GMT at 7 Months After Dose 1|HAI GMT against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208|||Antibody Titer||95% Confidence Interval|Geometric Mean
143434|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 84|Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 84|ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a viral load result obtained during that visit period.||log10 c/ml||Standard Deviation|Mean
143435|NCT00440947|Secondary|Change From Baseline in HIV-1 RNA at Week 36|Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 36|ITT-E Population, Induction Phase. Observed Population. Participants could only be included in the analysis if they had completed a Week 36 visit and had a viral load result obtained during that visit period.||log10 c/ml||Standard Deviation|Mean
143436|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 144|The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 144|ITT-Extension Population, Extension Phase. TLOVR.||participants|||Number
143437|NCT00440947|Secondary|Number of Participants Who Met the PDVF Criteria at Week 84|The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 84|ITT-Exposed Population, Randomized Phase. TLOVR. One participant met PDVF criteria at Week 36 and was included in the Week 36 PDVF but had been randomized; this participant is therefore also included in this PDVF tabulation.||participants|||Number
143438|NCT00440947|Secondary|Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36|The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA <400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound >=400 c/ml after achieving HIV-1 <400 c/ml.|Week 36|ITT-E Population, Induction Phase||participants|||Number
143439|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase||percentage of participants|||Number
143440|NCT00440947|Secondary|Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit|Percentage of PAR with HIV-1 RNA <400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA <400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 84|ITT-E Population, Randomized Phase||percentage of participants|||Number
143441|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA <400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to >=400 c/ml, or had an unconfirmed HIV RNA >=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 36|ITT-E Population, Induction Phase||percentage of participants|||Number
143442|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit|Percentage of PAR with HIV-1 RNA <50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (<100,000 and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA <50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.|Week 144|ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study||percentage of participants|||Number
143443|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit|A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA <50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.|Week 84|ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.||percentage of participants|||Number
143444|NCT00440947|Secondary|Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to >=50 c/ml, or had an unconfirmed HIV RNA >=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.|Week 36|ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study||percentage of participants|||Number
143446|NCT00440947|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit|The percentage of PAR with HIV-1 RNA virus <50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 c/ml and >=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.|Week 84|Intent-to-Treat (ITT)-Exposed Population, Randomized Phase: all PAR exposed to at least one dose of study medication during the Randomized Phase of the study. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of PAR with HIV-1 RNA <50 c/ml at Week 84 in the Simplification arm and Continuation arms||percentage of participants|||Number
143447|NCT00440830|Primary|Postoperative Pain Score Five Days After Surgery|Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|5 days|||Numeric Rating Scale (NRS)||Standard Deviation|Mean
143448|NCT00440830|Secondary|Heart Rate|Heart rate reported in Beats per minute (BPM)|1 hour after surgery||||||
143449|NCT00440830|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery||||||
143450|NCT00440830|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery||||||
143451|NCT00440830|Secondary|Pain Medication Used|Pain medication used after surgery in morphine equivalents|5 days||||||
143452|NCT00440830|Secondary|Sedation|Observer's Assessment of Alertness/Sedation Scale was used to report sedation.|1 hour after surgery||||||
143453|NCT00440830|Secondary|Nausea Assessment by Patient|Nausea scale range: 0=none and 10=the worst, ordinal.|1 hour after surgery||||||
143454|NCT00440830|Primary|Postoperative Pain Score One Hour After Surgery|Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.|1 hour after surgery|||Numeric Rating Scale (NRS)||Standard Deviation|Mean
143455|NCT00440700|Secondary|Urinary Cortisol|Stress was measured by the biomarker urinary cortisol. 24-hour urine collections were obtained from eligible participants who were not receiving steroids or other medications known to affect cortisol and who had intact renal function. 24-hour urinary cortisol results were used as an integrative measure of stress (mg/day).|Daily up to 30 days|All participants with functioning kidneys who were not receiving steroids or other medications known to affect cortisol and who had two or more 24-hour urine collections were included in the analysis.||total milligrams per day||Full Range|Median
143456|NCT00440700|Secondary|Length of Mechanical Ventilatory Support|Length of mechanical ventilatory support was defined as the number of days from initial intubation and placement on mechanical ventilation to the day of extubation or death for participants in each group.|From initial intubation date to extubation or death, whichever came first, assessed up to 30 days.|Includes all subjects enrolled regardless of length of protocol participation. Mean number of days mechanically ventilated was calculated for the subjects randomized to each group/arm.||days||Standard Error|Mean
143457|NCT00440700|Secondary|Length of ICU Stay|Length of ICU stay was measured in days from the first day participant was admitted to the unit until discharged, transferred, or died in the ICU. This was the total time that any participant was in the intensive care unit which could have been longer than the 30 study protocol .|From date of ICU admission to extubation or discharge or date of death from any cause, whichever came first assessed up to 60 days|The number of participants includes all of those patients who were enrolled into the study protocol, regardless of their length of study participation.||days||Standard Error|Mean
143458|NCT00440700|Primary|State Anxiety|"Participants reported their current level of anxiety each day enrolled in the study in response to the question how are you feeling today/ The Visual analog scale-anxiety was used to evaluate the self-report of anxiety. Scores range from 0 = not anxious at all to 100 = the most anxious ever. Higher numbers indicate greater anxiety. Daily anxiety scores from all subjects were combined and analyzed for each group resulting in an overall mean anxiety score at the end of the study protocol of 30 days."|Daily up to 30 days|Participants with 3 or more visual analog scale-anxiety ratings were included in the analysis.||units on a scale||Standard Deviation|Mean
143459|NCT00440700|Primary|Sedative Exposure|Sedative exposure was measured by: 1) the number (dose frequency) of sedative medication doses administered in a 4-hour time period each day and 2) by an aggregate dose intensity of sedative medications administered in a 4-hour time period each day based on all subjects receiving sedative medications on any individual study day yielding a sedation intensity score. A sedation intensity score was calculated for each study group each study protocol day, up to 30 days. Higher sedation intensity scores indicate more sedative exposure. If a subject did not receive any sedation, the sedative exposure score is zero for that respective day.|Daily up to 30 days|Participants with 2 or more days of study enrollment data were included in the analysis for this aim.||exposures/4-hours per day||Full Range|Median
143460|NCT00440557|Secondary|Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.|From baseline to Week 9|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization Hb concentration measurement.||participants|||Number
143461|NCT00440557|Post-Hoc|Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment|Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||g/dL/2 weeks||Standard Deviation|Mean
143634|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers 7 Months After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group seven months after receipt of the first dose of vaccine.|Approximately Day 208|||Participants|||Number
143462|NCT00440557|Other Pre-specified|Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||participants|||Number
143463|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||participants|||Number
143464|NCT00440557|Other Pre-specified|Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment|Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all subjects who received at least 1 injection of study drug.||participants|||Number
143465|NCT00440557|Other Pre-specified|Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||g/dL||Standard Deviation|Mean
143466|NCT00440557|Other Pre-specified|Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.|From baseline to Week 22|Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.||participants|||Number
143467|NCT00440557|Primary|Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22|The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.|From baseline through Week 22|Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization hemoglobin concentration measurement.||g/dL||Standard Deviation|Mean
143468|NCT00440531|Secondary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences||During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
143469|NCT00440531|Secondary|The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C||Day 1-5 After Vaccination|Safety Analysis Set - defined as all participants who received at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
143470|NCT00440531|Secondary|The Total Number of Participants With One or More Injection-site Adverse Experiences||Days 1-5 After Any Vaccination|Safety Analysis Set – defined as all participants who received at least one injection of vaccine and who had a safety follow-up.||Participants|||Number
143471|NCT00440531|Secondary|The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
143472|NCT00440531|Primary|The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)|The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).|7 months (1 month after third vaccination)|Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
143473|NCT00440518|Secondary|Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)|Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person’s ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject’s quality of life.|Baseline, last visit in the 17-week Trial Period|Of the 71 (Placebo), 70 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects in the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value), 64, 66, and 66 subjects respectively are included in this summary.||Scores on a scale||Standard Deviation|Mean
143474|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Participants|||Number
143475|NCT00440518|Secondary|Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Participants|||Number
143476|NCT00440518|Secondary|Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period||Baseline, last 4 weeks of the 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Number of migraine headaches||Standard Deviation|Mean
143477|NCT00440518|Primary|Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period||Baseline, Entire 14-week Maintenance Period|Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.||Number of migraine headaches||Standard Deviation|Mean
143478|NCT00440505|Secondary|Nausea|Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.||Units on a scale||Standard Deviation|Mean
143479|NCT00440505|Secondary|Number of Participants Who Reported an Increase in Daily Pain Medication Regime|Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.|1 day|This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.||Participants|||Number
143480|NCT00440505|Secondary|Patient Self-assessment of Psychological Distress|Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.||Units on a scale||Standard Deviation|Mean
143481|NCT00440505|Primary|Pain Score|Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.|1 day|This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.||Units on a scale||Standard Deviation|Mean
143482|NCT00440466|Other Pre-specified|Number of Participants Who Died||36 weeks of treatment|||Participants|||Number
143483|NCT00440466|Other Pre-specified|Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||g/dL/2 weeks||Standard Deviation|Mean
143484|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||Participants|||Number
143485|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|||Participants|||Number
143486|NCT00440466|Other Pre-specified|Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||Particpants|||Number
143487|NCT00440466|Other Pre-specified|Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||g/dL||Standard Deviation|Mean
143488|NCT00440466|Other Pre-specified|Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)||36 weeks of treatment|Safety population defined as all participants who received at least 1 injection of study drug||Participants|||Number
143489|NCT00440466|Secondary|Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)||Weeks 13-37|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.||Proportion||Full Range|Median
143490|NCT00440466|Primary|Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment||from baseline (Week 1) to the last 12 weeks of treatment|Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.||g/dL||Standard Deviation|Mean
143491|NCT00440401|Secondary|Proportion of Subjects Achieving Haemostasis at 6 Minutes.|Six minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|6 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."||Proportion of Subjects||95% Confidence Interval|Number
143492|NCT00440401|Primary|Proportion of Subjects Achieving Haemostasis at 3 Minutes|Three minutes after application of trial treatment (TachoSil® or standard fleece material) the investigator evaluated if haemostasis in the target area was achieved.|3 minutes|"Three subjects were randomised to standard treatment but incorrectly received TachoSil® instead. All other subjects received the trial treatment to which they were randomised. The intention to treat (ITT) population was defined as randomised and the Safety population (= basis for Adverse Events analyses) was defined as treated."||Proportion of Subjects||95% Confidence Interval|Number
143493|NCT00440310|Primary|Overall Survival|Time from randomization to death|Up to 184 weeks|ITT (All patient randomized/enrolled)||Days||Inter-Quartile Range|Median
150893|NCT00380250|Secondary|Month 3 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
143494|NCT00440297|Primary|The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences|Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).|0-9 months (recorded from first dose until the participant completes or discontinues the study)|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up||Participants|||Number
143495|NCT00440297|Primary|The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C||Days 1-5 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up||Participants|||Number
143496|NCT00440297|Primary|The Total Number of Participants With One or More Injection-Site Adverse Experiences||Days 1-15 After Any Vaccination|Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up||Participants|||Number
143497|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9|"The number of participants as measured by the~seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose)."|9 months (1 month after the fourth dose)|"Per-Protocol Population: The Per-~Protocol Population is defined as the participants that were able to complete the study as defined by the~protocol."||Participants|||Number
143498|NCT00440297|Primary|The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7|"The number of participants as measured by the~seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose)."|7 months (1 month after the third dose)|Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.||Participants|||Number
143499|NCT00440271|Secondary|Post-dose TPV and RTV Concentrations at Week 4||Week 4||||||
143500|NCT00440271|Secondary|Occurrence of TPV Trough Concentration >120 μM||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143501|NCT00440271|Secondary|Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143502|NCT00440271|Secondary|Patients Adherence With Study Medication Based on Pill Count||after 4 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143503|NCT00440271|Secondary|Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143504|NCT00440271|Secondary|Change in Ratio of CD38+/CD8+ From Baseline to Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143505|NCT00440271|Secondary|Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48||after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143506|NCT00440271|Secondary|Time to New AIDS or AIDS Related Progression Event or Death||after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143507|NCT00440271|Secondary|Time to Treatment Failure|For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.|after Day 1 of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143508|NCT00440271|Secondary|Change in Viral Load From Baseline at Each Visit||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143509|NCT00440271|Secondary|Percentage of Participants Whose ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143510|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143511|NCT00440271|Secondary|Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48||after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143512|NCT00440271|Primary|Treatment Response at Week 48|percentage of participants whose viral load <50 copies/mL at Week 48|after 48 weeks of treatment|The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.|||||
143515|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding, cardiovascular death, myocardial infarctions, stroke, or non CNS systemic embolism. Major bleeding was associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography ( PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143516|NCT00440193|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death, cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events confirmed by independent committee blinded to treatment, based on compression ultrasound, venography, spiral CT scan, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy, results/films/images of confirmatory testing and/or case summaries|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143517|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143518|NCT00440193|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143519|NCT00440193|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143520|NCT00440193|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143528|NCT00440193|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143521|NCT00440193|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143522|NCT00440193|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143523|NCT00440193|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
143524|NCT00440193|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
143525|NCT00440193|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
143526|NCT00440193|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143527|NCT00440193|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143543|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Dizziness|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
143544|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Orthopnea|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included||participants|||Number
143529|NCT00440193|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143530|NCT00440180|Primary|Pregnancy Rate|Partner pregnancy rate during study participation|4 months|||participants partner|||Number
143531|NCT00440050|Secondary|Neuropsychiatric Inventory (NPI)|The Neuropsychiatric Inventory quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.|18 months|||Units on a scale||Standard Deviation|Mean
143532|NCT00440050|Secondary|ADCS-ADL|ADCS-ADL = Alzheimer's Disease Cooperative Study Activities of Daily Living Score. This is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 6 with lower numbers indicating greater impairment.|18 months|||Units on a scale||Standard Deviation|Mean
143533|NCT00440050|Primary|Rate of Change on CDR-SOB|CDR-SOB = Clinical Dementia Rating, Sum of Boxes. This is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|18 months|||Units on a scale||Standard Deviation|Mean
143534|NCT00440050|Primary|Rate of Change on the ADAS-Cog 11.|ADAS-cog 11 = Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year. This is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|Baseline, 6, 12, 18 months|||ADAS points per year||Standard Deviation|Mean
143535|NCT00440011|Secondary|Tolerability - Conjunctival Hyperemia|Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)|Month 3|||participants|||Number
143536|NCT00440011|Primary|Intraocular Pressure (IOP)|Intraocular Pressure|Month 3|||mm Hg||Standard Deviation|Mean
143537|NCT00439946|Secondary|Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)|A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.|Week 8|||participants|||Number
143538|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)|The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua (e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Baseline and Week 8|All 8 participants are included.||units on a scale||Standard Deviation|Mean
143539|NCT00439946|Secondary|Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL. The CAMPHOR was completed at Baseline and at Week 8. The CAMPHOR consists of 3 scales: 1. A 25-item overall symptoms scale scored 0–25, with a higher score indicating the presence of more symptoms. 2. A 15 item Activity/Functioning scale scored 0–30, where a low score indicates good functioning. 3. A 25-item QoL scale scored 0–25, with a high score indicating poor QoL. Additionally, a total score was recorded by adding up the the scores from the 3 above scales. The Symptom and QoL scales have dichotomous (‘True’/‘Not true’) response options while the Activity/Functioning scale has three-point (‘Able to do on own without difficulty’/‘Able to do on own with difficulty’/‘Unable to do on own’) response options. Reduction in score denotes improved heath status.|Baseline and Week 8|One subject was missing a questionnaire page of the CAMPHOR; Therefore, the component score of||units on a scale||Standard Deviation|Mean
143540|NCT00439946|Secondary|Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol|A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g. diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin.|Week 8|||minutes||Standard Deviation|Mean
143541|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Chest Pain|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
143542|NCT00439946|Secondary|Change From Baseline at Week 8 in PAH Symptoms- Syncope|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
143548|NCT00439946|Secondary|Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification|WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living. The scale ranges from class I to class IV. In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class.|Week 8|All Subjects transitioned from IV epoprostenol to IV treprostinil were included.||participants|||Number
143549|NCT00439946|Secondary|Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Week 8|Two subjects did not have Baseline Borg scores and were excluded from this analysis.||units on a scale||Standard Deviation|Mean
143550|NCT00439946|Primary|Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)|The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002].|Week 8|Two subjects did not have Baseline 6MWTs and were excluded from this analysis.||meters||Standard Deviation|Mean
143551|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143552|NCT00439777|Post-Hoc|Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment|Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143553|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143554|NCT00439777|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143555|NCT00439777|Other Pre-specified|Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143635|NCT00439335|Secondary|Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose of vaccine.|Approximately Day 28|||Participants|||Number
143556|NCT00439777|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143557|NCT00439777|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|Up to 30 days after the last intake of study medication|Participants entering the observational period were participants for whom the investigator indicated on the eCRF (electronic case report form) that the participant entered the observational period or had a confirmed event more than one day and up to 30 days after the last dose as a component of the respective composite outcome.||Percentage of participants|||Number
143558|NCT00439777|Other Pre-specified|Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143559|NCT00439777|Secondary|Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)|All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
143560|NCT00439777|Secondary|Percentage of Participants With All Deaths|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
143561|NCT00439777|Secondary|Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|3-, 6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of anticoagulant study treatment after randomization (i.e. enoxaparin, warfarin, acenocoumarol, rivaroxaban). Participants were analyzed according to the treatment they actually received.||Percentage of participants|||Number
143562|NCT00439777|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143563|NCT00439777|Secondary|Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143636|NCT00439335|Secondary|HAI GMT After Dose 1|HAI GMT against influenza A/H5N1 virus one month after receipt of the first dose of vaccine.|Approximately Day 28|||Antibody titer||95% Confidence Interval|Geometric Mean
143564|NCT00439777|Secondary|Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment|Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143565|NCT00439777|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143566|NCT00439777|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.|3-, 6-, or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143567|NCT00439738|Secondary|Change From Baseline in Postprandial Non-esterified Fatty Acids|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis||mg/dL||Standard Deviation|Mean
143568|NCT00439738|Secondary|Change From Baseline in Postprandial Insulin|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis||mg/dL||Standard Deviation|Mean
143569|NCT00439738|Secondary|Change From Baseline in Postprandial Glucose|After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test|Week 16|Only those patients who completed the study through week 16 were included in this analysis.||mg/dL||Standard Deviation|Mean
143570|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg|Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)||participants|||Number
143571|NCT00439738|Secondary|Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)|Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg|Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)|Intent to Treat (ITT)||participants|||Number
143572|NCT00439738|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline to Weeks 4, 8, 12 and 16|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
143573|NCT00439738|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP)||Baseline to Week 8|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
143574|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent DVT During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound or venography, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143575|NCT00439725|Other Pre-specified|Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143576|NCT00439725|Other Pre-specified|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period|Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units, occurring in a critical site or contributing to death.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143577|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143578|NCT00439725|Other Pre-specified|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143579|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143580|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries.|30 days observational period after last intake of study medication|Intention-to-treat (ITT) population entering observational period. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143581|NCT00439725|Other Pre-specified|Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143582|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143583|NCT00439725|Other Pre-specified|Percentage of Participants With Death (PE) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143584|NCT00439725|Secondary|Percentage of Participants With Other Vascular Events|All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
143585|NCT00439725|Secondary|Percentage of Participants With All Death|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
150894|NCT00380250|Secondary|Month 2 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
143586|NCT00439725|Secondary|Percentage of Participants With Clinically Relevant Bleeding|All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication [‘time window: 2 days’]) and all events post randomization were reported|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
143587|NCT00439725|Secondary|Percentage of Participants With Major Bleeding|All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported.|6- or 12-month study treatment period|The valid-for-safety analysis population consisted of all participants who were randomized with valid informed consent and received at least one dose of study treatment. For this population, participants were analyzed according to the treatment they received.||Percentage of participants|||Number
143588|NCT00439725|Secondary|Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143589|NCT00439725|Secondary|Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143590|NCT00439725|Secondary|Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143591|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143592|NCT00439725|Secondary|Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), or lung scintigraphy (for PE), and/or case summaries.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143593|NCT00439725|Primary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of DVT/PE, kindly refer to the link in the Protocol section.|6- or 12-month study treatment period|The intention-to-treat (ITT) population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||Percentage of participants|||Number
143594|NCT00439647|Secondary|Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits||Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24|The ITT, Intent to Treat population, includes all participants who received a single a dose of treatment and had data available for analysis. n = the number of subjects with evaluable measurements at visit, as determined by the efficacy window.||ng/mL||Standard Error|Mean
143595|NCT00439647|Secondary|Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.||Percent change in BMD||Standard Error|Least Squares Mean
143596|NCT00439647|Secondary|Percentage Change From Baseline in Total Hip BMD (g/CM^2)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.||Percent change in BMD||Standard Error|Least Squares Mean
143597|NCT00439647|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)|Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)|Month 6, Month 12, Month 24|Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.||Percent change in BMD||Standard Error|Least Squares Mean
143598|NCT00439647|Secondary|Number of Participants With First Non-vertebral Fracture|Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.||Participants|||Number
143599|NCT00439647|Secondary|Number of Participants With First Clinical Fracture|Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.||Participants|||Number
143600|NCT00439647|Secondary|Number of Participants With First Clinical Vertebral Fracture|Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.|24 months|The ITT (intent to treat) population consisted of all subjects as randomized.||Participants|||Number
143601|NCT00439647|Secondary|Mean Change in Height From Baseline|Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis|from Baseline to 12 months and 24 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||mm||Standard Error|Mean
143602|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, Month 24|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.||Percentage of Participants|||Number
143603|NCT00439647|Secondary|Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months|Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)|Baseline, 12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of Participants|||Number
143604|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of participants|||Number
143637|NCT00439335|Secondary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.|Number of participants achieving a 4-fold or greater increase in HAI antibody titers against influenza A/H5N1 virus in each vaccine group one month after receipt of the first dose.|Approximately Day 28|||Participants|||Number
151577|NCT00373360|Secondary|Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
143605|NCT00439647|Secondary|Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months|Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.|12 months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of participants|||Number
143606|NCT00439647|Secondary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|12 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.||Percentage of participants|||Number
143607|NCT00439647|Primary|Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months|Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height|24 Months|Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. In this analysis, missing Month 24 fractures were imputed using LOCF.||Percentage of Participants|||Number
143608|NCT00439608|Secondary|Measure of Safety and Tolerability According to CTC Version 3.0||30 days||||||
143609|NCT00439608|Primary|Reponse Rate at Time of Surgery by Tissue|pathologic complete response rate at surgery|within 30 days of last treatment|||participants|||Number
143610|NCT00439569|Secondary|Overall Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 Weeks|Four of the nine subjects enrolled were less than 80% compliant. The study was closed prematurely due to poor compliance with study drug administration.||Participants|||Number
143611|NCT00439569|Secondary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Area Under the Plasma Concentration versus Time curve (AUC)|12 weeks|||µmol/L * hours||Standard Deviation|Mean
143612|NCT00439569|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Change in SMN Protein level||Standard Deviation|Mean
143613|NCT00439569|Secondary|Pharmacokinetic Parameters (Time to Maximum Concentration)|Time to Maximum Concentration (Tmax)|12 weeks|||Hours||Standard Deviation|Mean
143614|NCT00439569|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks|||µM||Standard Deviation|Mean
143615|NCT00439569|Secondary|Drug Safety|Adverse event(AE)monitoring|14 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the study monitoring committee (SMC).||Adverse Events|||Number
143616|NCT00439569|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to poor compliance with study drug administration. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Change in mRNA level||Standard Error|Mean
143617|NCT00439569|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade (GR)3 or higher adverse event(AE),GR 1 or higher cardiac arrhythmia;GR 2 or higher vomiting;GR 2 or higher liver dysfunction/failure (clinical);GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis.The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor:decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT,bilirubin;abnormality of Na, K, Cl, Ca, HCO3, glucose, BUN or creatinine.|29 Days|The study was closed prematurely due to poor compliance with study drug administration. The MTD could not be determined as it was less than the lowest dosage studied (500 mg/kg/day).||DLT(s)|||Number
143618|NCT00439517|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Safety population||participants|||Number
143619|NCT00439517|Secondary|Treatment Impact on Social Daily Living and Health Care Resource Utilization|Non-protocol medical care visits and consultations|From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009|ITT population||visits or consultations|||Number
143638|NCT00439335|Secondary|Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2|Number of participants achieving a serum HAI titer of greater than or equal to 40 against influenza A/H5N1 virus in each vaccine group 28 days after receipt of the second dose of vaccine|Approximately Day 56|||Participants|||Number
143620|NCT00439517|Secondary|QOL Therapy Preference Questionnaire (TPQ)|TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|"Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population.~The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles"||percentage of participants|||Number
143621|NCT00439517|Secondary|QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire|The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.|at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.||scores on a scale||Standard Error|Least Squares Mean
143622|NCT00439517|Secondary|Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)|All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0=”Not at all” to 4=”Very much”. For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL.|At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays|Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population||scores on a scale||Standard Error|Least Squares Mean
143623|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011|ITT population i.e. all randomized subjects.||months||95% Confidence Interval|Median
143624|NCT00439517|Secondary|Overall Survival (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.||months||95% Confidence Interval|Median
143625|NCT00439517|Secondary|Best Overall Response (BOR)|"BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as Disappearance of all target lesions plus disappearance of all non-target lesions & without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later"|Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|ITT population i.e. all randomized subjects.||percentage of participants||95% Confidence Interval|Number
143626|NCT00439517|Primary|Progression-free Survival (PFS)|Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria|Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009|Intention-to-treat (ITT) population i.e. all randomized subjects .||months||95% Confidence Interval|Median
143627|NCT00439413|Secondary|Abstinence|The proportion is determined by dividing the number who achieved abstinence at the end of treatment as defined for the primary outcome measure and are still abstinent by self report and separately by self report with confirmation by exhaled CO by the total number randomized to the treatment group.|week 14|||participants|||Number
143628|NCT00439413|Primary|Quit Rate|The number of subjects in each treatment group who ceased smoking as measured by four weeks of self-reported abstinence confirmed by at least two exhales - carbon monoxide (CO) measurements during the last four weeks of treatment (study weeks 6 through 9).|Study weeks 6 through 9|||participants|||Number
143629|NCT00439335|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting pain, tenderness, itching, induration, erythema, and pigmentation. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination|||Participants|||Number
143630|NCT00439335|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.|The number of participants reporting fever, feverishness, malaise, myalgia, headache and nausea. Participants are counted only once for each symptom but may have experienced symptoms on multiple occasions.|7 days after each vaccination|||Participants|||Number
143631|NCT00439335|Primary|Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 28 days of vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Through approximately Day 56|||Participants|||Number
143640|NCT00439335|Primary|Number of Participants Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|Through Day 208.|||Participants|||Number
143641|NCT00439335|Primary|Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2|Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine|Approximately Day 56.|||Participants|||Number
143642|NCT00439309|Secondary|Time to Wound Closure|Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.|From initial clamp removal at the last anastomotic site until skin closure|||Minutes||95% Confidence Interval|Median
143643|NCT00439309|Secondary|Time to Hemostasis|Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.|Within 10 minutes post restoration of blood flow|||Minutes||95% Confidence Interval|Median
143644|NCT00439309|Secondary|Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.|Within 10 minutes post restoration of blood flow|||percentage of anastomitic sites|Participants||Number
143645|NCT00439309|Secondary|Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)|A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow|60 seconds post restoration of blood flow|||percentage of anastomotic sites|Participants||Number
143646|NCT00439309|Primary|Sealing Success|The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.|Within 10 minutes following restoration of blood flow|The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.||percentage of participants||95% Confidence Interval|Number
143647|NCT00439270|Secondary|Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests|ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (*10^9/L), Grade 3, <1.0-0.5; Grade 4, <0.5. Hemoglobin (mmol/L), Grade 3, <4.9-4.0; Grade 4, <4.0. Platelets (*10^9/L), Grade 3, <50.0-25.0; Grade 4, <25.0. Leukocytes (*10^9/L) Grade 3, <2.0-1.0; Grade 4, <1.0. ALP, ALT, and AST (*ULN), Grade 3, >5.0-20.0; Grade 4, >20.0. Total bilirubin (*ULN), Grade 3, >3.0-10.0; Grade 4, >10.0. Creatinine (*ULN), Grade 3, >3.0-6.0; Grade 4, >6.0. Hypercalcemia (mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. Prothrombin time (seconds), Grade 3, >2.0; Grade 4, not defined.|From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)|All participants who received at least 1 dose of study drug||Participants|||Number
143648|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel||Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose|All patients who received at least 1 dose of dasatinib||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
143649|NCT00439270|Secondary|Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel||Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable||ng/mL||Geometric Coefficient of Variation|Geometric Mean
143650|NCT00439270|Secondary|Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel||Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose|All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
143651|NCT00439270|Secondary|Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Participants|||Number
143671|NCT00439218|Secondary|Pharmacokinetic Parameters (Time to Maximum Plasma Concentration)|Time to maximum plasma concentration (Tmax)|12 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Hours||Standard Deviation|Mean
143672|NCT00439218|Secondary|Pharmacokinetic Parameters (Maximum Plasma Concentration)|Maximum Plasma Concentration (Cmax)|12 weeks|||µM||Standard Deviation|Mean
143652|NCT00439270|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.|From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)|All participants who received at least 1 dose of dasatinib||Participants|||Number
143653|NCT00439270|Secondary|Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6|The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.|At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle.||Units on a scale||Full Range|Median
143654|NCT00439270|Secondary|Percentage of Participants With Improvement on Bone Scan|Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Percentage of participants||95% Confidence Interval|Number
143655|NCT00439270|Secondary|Number of Participants by Best On-study Bone Scan Assessment From Baseline|Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.|From Day 1 of therapy to last bone scan assessment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Participants|||Number
143656|NCT00439270|Primary|Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2|Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m^2) was based on the docetaxel package insert.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1||mg|||Number
143657|NCT00439270|Secondary|Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR.~PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present.~To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change."|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Participants|||Number
143658|NCT00439270|Secondary|Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.|Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Percentage of participants||95% Confidence Interval|Number
143659|NCT00439270|Secondary|Number of Months of Progression-free Survival (PFS)|"PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following:~tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status."|Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Months||95% Confidence Interval|Median
143660|NCT00439270|Secondary|Duration of Prostate Specific Antigen (PSA) Response|Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5*baseline or nadir PSA).|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment|All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m^2 and who had a PSA response||Months||95% Confidence Interval|Median
143661|NCT00439270|Primary|Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel|MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for >14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.|From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)|All patients who received at least 1 dose of dasatinib in Phase 1||mg|||Number
143662|NCT00439270|Secondary|Percentage of Participants With a Prostate Specific Antigen (PSA) Response|PSA response rate is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements|At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)|All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2||Percentage of participants||95% Confidence Interval|Number
143663|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)|Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window||ng/mL||Standard Deviation|Mean
143664|NCT00439244|Secondary|Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)|Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory.|At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. n = ITT patients with a measurement at each visit, as determined by the efficacy visit window||ng/mL||Standard Deviation|Mean
143665|NCT00439244|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52|BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13, Week 26 and Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.||Percent Change||Standard Error|Least Squares Mean
143666|NCT00439244|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 13 and Week 26|The intent-to-treat (ITT) population consisted of all randomized patients with available data. ITT patients with evaluable measurements at both baseline and post-baseline within each efficacy visit window were analyzed.||Percent Change||Standard Error|Least Squares Mean
143667|NCT00439244|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.|Baseline through Week 52|The intent-to-treat (ITT) population consisted of all randomized patients with available data.||Percent change||Standard Error|Least Squares Mean
143668|NCT00439231|Primary|To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen|To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen|24 weeks of lenalidomide therapy|||participants|||Number
143669|NCT00439218|Secondary|Overall Study Drug Compliance|Subjects receiveing 80% or more of the prescribed doses within each study visit interval were considered compliant.|12 weeks|A total of 5 participants were enrolled in the study. Four enrolled in Cohort 1.||Participants|||Number
143673|NCT00439218|Primary|Survival Motor Neuron (SMN) Protein|The change of level in blood SMN protein from baseline to assess time course and dose response.|Baseline - 12 Weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||SMN/beta tubulin||Standard Deviation|Mean
143674|NCT00439218|Secondary|Drug Safety|Adverse event (AE) monitoring|14 weeks|The study was closed prematurely due to slow accrual. These data have not yet been analyzed. Their interpretability will be limited because of the small number of subjects enrolled. There were no safety concerns reported by the SMC.||Adverse Events|||Number
143675|NCT00439218|Primary|Survival Motor Neuron (SMN) Messenger Ribonucleic Acid (mRNA)|The change of level in blood SMN mRNA from baseline to assess time course and dose response.|Baseline - 12 weeks|The study was closed prematurely due to slow accrual. These data are exploratory and have not yet been analyzed. Their interpretability will be limited because of the small number of specimens collected.||Cycle Threshold (Ct)||Standard Error|Mean
143676|NCT00439218|Primary|Dose Limiting Toxicities (DLT)|Number of DLTs to determine the maximum tolerated dosage. A DLT is defined as any Grade(GR)3 or higher adverse event, GR 1 or higher cardiac arrhythmia; GR 2 or higher vomiting; GR 2 or higher liver dysfunction/failure (clinical); GR 2 elevation of amylase or lipase accompanied by clinical symptoms of pancreatitis. The following GR 2 events are classified as DLTs if evaluated to be clinically significant by the principal investigator or medical safety monitor: decrease of hemoglobin, WBCs, platelets; elevation of AST, ALT, bilirubin; abnormlity of Na, K, Cl, CA, HCO3, glucose, BUN, creatinine.|29 days|The study was closed prematurely due to slow accrual. The MTD could not be determined due to the small number of subjects enrolled.||DLT(s)|||Number
143677|NCT00439179|Secondary|Number of Patients Who Experienced a Partial Response|To assess clinical activity of GW572016 with gemcitabine and with the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers.|every two months until progression|||participants|||Number
143678|NCT00439179|Primary|Toxicity (Number of Patients Who Experiened DLTs)|To determine the safety and tolerability of GW572016 when administered with gemcitabine and the combination of gemcitabine and oxaliplatin in patients with advanced pancreaticobiliary cancers. Numbers below are DLTs|until death, approximately 2 years|||participants|||Number
143679|NCT00439140|Other Pre-specified|Number of Participants With at Least a 20% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.||Participants|||Number
143680|NCT00439140|Other Pre-specified|Number of Participants With at Least a 15% Decrease From Baseline in FVC|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.|Baseline, Weeks 2, 6 and 12|Safety population included all randomized participants who received treatment.||Participants|||Number
143681|NCT00439140|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).|Baseline, Week 6|Intent-to-treat population included all randomized participants.||mL||Standard Deviation|Mean
143682|NCT00439140|Secondary|Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)|MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).|Baseline, Week 6|Intent-to-treat population included all randomized participants.||cm H2O||Standard Deviation|Mean
143683|NCT00439140|Secondary|Change From Baseline in the Number of Urinary Incontinence Episodes|The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).|Baseline, Week 6|Participants from the Intent-to-treat population (all randomized participants) using observed data for analysis.||Episodes||Standard Deviation|Mean
143684|NCT00439140|Primary|Change From Baseline in FEV1/FVC Ratio|The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.||Ratio||Standard Deviation|Mean
143685|NCT00439140|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety population included all randomized participants who received treatment.||Liters||Standard Deviation|Mean
143686|NCT00439140|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.|Baseline, Week 6|Safety Population included all randomized participants who received treatment.||Liters||Standard Deviation|Mean
143687|NCT00438971|Other Pre-specified|Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of psychosocial functioning in work, interpersonal relations, satisfaction, and recreation. Scores on the LIFE-RIFT can range from 4, indicating very good functioning (no impairment) in all of the 4 component areas, to 20, indicating very poor functioning (severe impairment) in all of the 4 areas.|8 weeks|||units on a scale||Standard Deviation|Mean
143688|NCT00438971|Other Pre-specified|Sheehan Disability Scale (SDS)|The SDS is a 3-item measure with each item rated on a 10-point scale. The SDS measures the extent to which work/school, social life, and home life or family responsibilities are impaired by symptoms. Total scores range from 0 to 30, with higher scores reflecting greater impairment.|8 weeks|||units on a scale||Standard Deviation|Mean
143689|NCT00438971|Other Pre-specified|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Q-LES-Q is a self-report measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Only the first 14 items are included in scoring, which ranges from 14 to 70, with higher scores reflecting greater enjoyment and satisfaction. The last two items are not included in the total score but are standalone items.|8 weeks|||units on a scale||Standard Deviation|Mean
143690|NCT00438971|Other Pre-specified|Beck Anxiety Inventory (BAI)|The BAI is a 21-item self-report measure of anxiety with a focus on somatic symptoms. Total scores range from 0 to 63, with higher scores reflecting greater symptom severity.|8 weeks|||units on a scale||Standard Deviation|Mean
143691|NCT00438971|Other Pre-specified|Montgomery Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item clinician rating of depressive symptoms. Scores range from 0 to 60, with higher scores reflecting greater symptom severity.|8 weeks|||units on a scale||Standard Deviation|Mean
143692|NCT00438971|Secondary|Panic Attack Scale (PAS)|The PAS is a measure that assesses participants' total number of panic attacks (situational and unexpected with full and limited symptoms), as well as anticipatory anxiety, since last visit. There is no total score.|8 weeks|||units on a scale||Standard Deviation|Mean
143693|NCT00438971|Secondary|Clinical Global Impression of Severity Scale (CGI-S)|The CGI-S is a clinician-rated instrument used to assess global severity of symptoms. The CGI-S ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Remission was defined strictly as a CGI-S score of 1 or 2 (not at all ill or borderline ill) and zero panic attacks at endpoint.|8 weeks|||units on a scale||Standard Deviation|Mean
143694|NCT00438971|Primary|Panic Disorder Severity Scale (PDSS)|The PDSS contains seven items assessing multiple dimensions of panic disorder severity, including (a) frequency of panic attacks, (b) distress during panic attacks, (c) anticipatory anxiety, (d) agoraphobic fear and avoidance, (e) interoceptive fear and avoidance, (f) impairment of work functioning, and (g) impairment of social functioning. The PDSS ranges from 0 to 28, with higher ratings reflecting greater degrees of symptom severity.|8 weeks|||units on a scale||Standard Deviation|Mean
143695|NCT00438932|Secondary|24-hour Urinary Phosphate|from 24-hr urine collections|2 weeks|||mg||Standard Error|Mean
143696|NCT00438932|Primary|Fibroblast Growth Factor 23 (FGF-23)|Plasma FGF-23 was measured using c-terminal FGF23 assay.|2 weeks|||RU/ml||Standard Error|Mean
143697|NCT00438880|Secondary|Duration of Response|Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond.|Up to 1 year from treatment start date|The duration of response was not analyzed due to a lack of more than one response.|||||
143698|NCT00438880|Secondary|Progression-free Survival|The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.|Up to 1 year from treatment start date|Only participants accrued to the Phase II portion of the study were evaluated for this endpoint.||months||95% Confidence Interval|Median
143699|NCT00438880|Primary|Tumor Response|"Complete Response (CR):~No measurable or nonmeasurable disease.~No symptoms of Lymphoma.~Non-palpable spleen, if palpable at baseline.~Histologically negative bone marrow, if positive at baseline.~All nodes <1.5 cm in transverse diameter.~Partial Response (PR):~greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions.~No new lesions~We are reporting the number of participants that attained a status of CR or PR."|Evaluations occur every three months up to a year|Participants accrued to the Phase I portion of this study were not used to analyze the Phase II primary endpoint.||participants|||Number
143700|NCT00438880|Primary|Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level|"Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following:~Absolute neutrophil counts or platelet counts below 10*10^9/L for 14 days~Absolute neutrophil counts greater than 0.5 or less than 1*10^9/L~Platelet counts greater than 10 or less than 50*10^9/L for 28 days.~Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.~We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity."|at least 10 weeks post treatment up to 3 months.|Only participants accrued to the Phase I portion of this study were used to determine the maximum tolerated dose.||participants|||Number
143701|NCT00438854|Secondary|and to Correlate LYN Kinase Activity With Response in Study Subjects.||2 years||||||
143702|NCT00438854|Secondary|to Define the Spectrum of Toxicities of This Treatment in This Patient Population||2 years||||||
143703|NCT00438854|Secondary|to Determine the Progression-free Survival and Overall Survival||TBD||||||
143704|NCT00438854|Secondary|Duration of Overall Response for All Patients||TBD||||||
143705|NCT00438854|Secondary|The Complete Response Rate Will Also be Evaluated||TBD||||||
143706|NCT00438854|Primary|Overall Objective Response Rate in Terms of Complete Response, Nodular Partial Response, and Partial Response to Treatment With Dasatinib for Patients With CLL/SLL (Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma).||2 years|||participants who responded|||Number
143707|NCT00438815|Primary|Percent of HAE Attacks With Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. The conservative analysis defined substantial relief as 3 consecutive assessments of improvement of the defining symptom; any attack that did not have 3 consecutive documented reports of improvement was considered a treatment failure. In the less conservative analysis, attacks also were considered to have responded if clinical improvement of the defining symptom occurred but data were incomplete due to cessation of symptom assessments.|Within 4 hours after initial treatment|ITT-E Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).||percent of attacks|||Number
143708|NCT00438815|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=74).||mg/dL||Standard Deviation|Mean
143709|NCT00438815|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=82).||percent of functional C1INH||Standard Deviation|Mean
143710|NCT00438815|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour after the initial dose of study drug.|Pre-infusion to 1 hour post-infusion|ITT-E subjects with data at both sampling time points (N=84).||mg/dL||Standard Deviation|Mean
143711|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom for Subjects Who Received Multiple Treatments|For attack number 1, the number of censored observations precluded estimation of the 95% confidence interval (CI) upper bound for median time to event (subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations). Entry of 4.0 hours indicates that data were not estimable (NE); as non-numeric data are not supported by the 95% CI field, entry of the actual result (ie, NE or >4.0) was not possible.|Within 4 hours after initial treatment|ITT-E subjects with at least 10 HAE attacks during the study (N=15).||hours||95% Confidence Interval|Median
143712|NCT00438815|Secondary|Time to Beginning of Substantial Relief of the Defining Symptom|Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-E Population.||hours||95% Confidence Interval|Median
143713|NCT00438815|Primary|Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf||Duration of the study (2.5 years)|Intent-to-treat Efficacy (ITT-E) Population (N=101; the number of subjects who received at least one dose of C1INH-nf for the treatment of an acute HAE attack).||attacks|||Number
143714|NCT00438750|Secondary|Grip Strength|Measured with use of a grip meter as the average of three attempts.|6 months|||Pounds (lbs)||Standard Deviation|Mean
143715|NCT00438750|Secondary|Mayo Wrist Score|A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.|6 months|||units on a scale||Standard Deviation|Mean
143716|NCT00438750|Secondary|Gartland and Werley Score|An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.|6 months|||units on a scale||Standard Deviation|Mean
143717|NCT00438750|Secondary|Pinch Strength|"Pinch strength measured with the B&L pinch gauge.~B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym)."|6 months|||Pounds (lbs)||Standard Deviation|Mean
143718|NCT00438750|Secondary|10-point Ordinal Pain Scale|A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.|6 months|||units on a scale||Standard Deviation|Mean
143719|NCT00438750|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.~Mean and standard deviations are identical for both arms."|6 months|||units on a scale||Standard Deviation|Mean
143720|NCT00438750|Primary|Range of Motion in Degrees of the Wrists|"Mean arc of wrist flexion and extension six months after surgery.~Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees."|6 months|||Degrees||Standard Deviation|Mean
143721|NCT00438672|Primary|Visual Analog Scale for Pain|Pain is measured on a 10 cm long line that starts at 0 on the left and ends with 10 on the right. A score of 0 represents no pain at all, and a score of 10 represents the worst pain ever. The individual score is measured using a measuring rod, measuring the distance from the left border in centimeters.|6 months|||units on a scale||Standard Deviation|Mean
143722|NCT00438672|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|6 months|||units on a scale||Standard Deviation|Mean
143723|NCT00438659|Secondary|Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).|Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)|During Radiation Treatment, up to a maximum of 11 weeks.|||units on a scale||Standard Deviation|Mean
143724|NCT00438659|Secondary|Adverse Events Assessed Clinically by NCI CTCAE v3.0||During Radiation Treatment, up to a maximum of 9 weeks.|||participants|||Number
143725|NCT00438659|Secondary|QOL Domains as Measured by LASA|Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.||units on a scale||Standard Deviation|Mean
143726|NCT00438659|Secondary|Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)|Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).|During Radiation Treatment, up to a maximum of 11 weeks.|Patients who completed at least 1 assessment were evaluable for this secondary end point.||units on a scale||Standard Deviation|Mean
143727|NCT00438659|Secondary|Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.|To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.|During Radiation Treatment, up to a maximum of 9 weeks.|This analysis was not completed due to too little incidence of the dermatitis.|||||
143728|NCT00438659|Secondary|Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).|Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).|During Radiation Treatment, up to a maximum of 11 weeks.|||score on a 0-6 scale||Standard Deviation|Mean
143729|NCT00438659|Secondary|Skin Toxicity as Measured by the Skin Toxicity Assessment Tool|Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.|During Radiation Treatment, up to a maximum of 9 weeks.|||Score on a 0 to 5 scale||Standard Deviation|Mean
143730|NCT00438659|Secondary|Incidence of Severe ( Grade >=3) Radiation Dermatitis|To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.|During Radiation Treatment, up to a maximum of 9 weeks.|||Paticipants|||Number
143731|NCT00438659|Primary|Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.|Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).|During Radiation Treatment, up to a maximum of 9 weeks.|||Grade||Full Range|Mean
143732|NCT00436748|Secondary|Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age|Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).|Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose|Due to the low number of participants <6 years of age summary concentration analyses were not performed.|||||
143733|NCT00436748|Secondary|Number of Participants Who Developed Anti-erythropoiesis Antibodies|Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen’s Surface Plasmon Resonance Immunoassay (SPRIA) method.|25 weeks|Safety analysis set with both pre and postdose immunoassay antibody results||participants|||Number
143734|NCT00436748|Secondary|Change From Baseline in Diastolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."||mmHg||Standard Deviation|Mean
143735|NCT00436748|Secondary|Change From Baseline in Systolic Blood Pressure Over Time||Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."||mmHg||Standard Deviation|Mean
143736|NCT00436748|Secondary|Maximum Increase in Hemoglobin Over Any 2 Week Period|The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.|25 weeks|Safety analysis set||g/dL/2 weeks||Standard Deviation|Mean
143737|NCT00436748|Secondary|Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study||25 weeks|Safety analysis set||participants|||Number
143738|NCT00436748|Secondary|Hemoglobin Serial Rate of Change (ROC) Over Time|Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Safety analyis set with available data at each time point (indicated by n)."||g/dL/week||Full Range|Median
143739|NCT00436748|Secondary|Number of Participants With Treatment-emergent Adverse Events|A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies.|25 weeks|Safety analysis set including all participants who received ≥ 1 dose of investigational product.||participants|||Number
143740|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL child self-reported questionnaire was used in children > 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item’s score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set aged > 5 years and with available data for each score at each time point (indicated by n)."||units on a scale||Standard Error|Mean
143741|NCT00436748|Secondary|Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores|The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children ≥ 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents’ perceptions of their child’s HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item’s score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).|Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)|"Efficacy analysis set with available data for each score at each time point (indicated by n)."||units on a scale||Standard Error|Mean
143985|NCT00436345|Secondary|Duration of Weaning|Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.|up to 38 days (912 hours)|ITT Population. Only participants for which data are available were analyzed.||hours||Standard Deviation|Mean
143742|NCT00436748|Secondary|Darbepoetin Alfa Weight-Adjusted Dose Over Time|Arithmetic means are provided; Withheld doses are counted as 0 μg.|Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n). Numbers > 0 on non-darbepoetin alfa dosing weeks for the Q2W group reflect participants who did not receive the assigned placebo dose (eg, dose withheld per investigator decision based on hemoglobin value or missed visit)."||μg/kg||Standard Deviation|Mean
143743|NCT00436748|Secondary|Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL|The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level ≥ 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL) for whom dosing data were available.||μg/kg||Standard Deviation|Mean
143744|NCT00436748|Secondary|Hemoglobin Concentration Over Time||Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.|"Efficacy analyis set with available data at each time point (indicated by n)."||g/dL||Standard Deviation|Mean
143745|NCT00436748|Secondary|Time to First Hemoglobin Value ≥ 10.0 g/dL|The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL.|24 weeks|Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL)||days||Inter-Quartile Range|Median
143746|NCT00436748|Primary|Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL|The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.|24 weeks|Efficacy analysis set||proportion of participants||95% Confidence Interval|Number
143747|NCT00438490|Secondary|Reproductive Hormones-LH, FSH, Estradiol||7 days||||||
143748|NCT00438490|Secondary|Menstrual Cycle Length||28 days||||||
143749|NCT00438490|Secondary|Bone Turnover-deoxypyridinoline, N-telopeptide, Bone Specific Alkaline Phosphatase||7 days||||||
143750|NCT00438490|Primary|Galactorrhea|Galactorrhea is breast milk production.|7 days|||percentage of participants|||Number
143751|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Within Placebo Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Full Range|Median
143752|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Full Range|Median
143753|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Placebo Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 94 enrolled participants in the Placebo Arm, 68 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
143754|NCT00438464|Secondary|Comparison of Biomarkers Between Gleason Grades GG3 & GG4: Percentage of Tumor Cells Exhibiting Detectable Staining Within Finasteride Treatment Arm for Biomarker Subgroups (Mean)|Molecular marker expression compared between tumor foci, characteristics of blood biomarkers using pretreatment and posttreatment values. VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period|Of total 89 enrolled participants in the Finasteride Arm, 62 participants had either a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
143764|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor Volume (Cubic Centimeter)|Characteristics of tumor considering total zone cancer volume, and cancer volume using zonal foci categorized as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||cubic centimeter||Full Range|Median
143765|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Upgrade Between Biopsy and Prostatectomy|Change in Gleason Score from biopsy to prostatectomy where an upgrade refers to a higher Gleason Score signifying worsening of tumor. Gleason scoring (GS) to based on microscopic appearance using 2005 International Society of Urological Pathologists recommendation.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||participants|||Number
143755|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Molecular marker expression compared between tumor foci using biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
143756|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression compared between tumor foci using Biomarkers pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C.|At prostatectomy following maximum 6 week treatment period.|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Standard Deviation|Mean
143757|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 4 (GG4) Biomarker Subgroup at Prostatectomy|Biomarkers using pretreatment and posttreatment values. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: VEGF denotes vascular epithelial growth factor, ERβ estrogen receptor beta, AR androgen receptor, SRD5A2, 3-oxo-5α-steroid 4-dehydrogenase 2, UBE2C, ubiquitin-conjugating enzyme E2C. P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage of tumor cell involvement||Full Range|Median
143758|NCT00438464|Primary|Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at Prostatectomy|Molecular marker expression based on tissue microarray (TMA) derived from dominant tumor focus. Staining microarrays for high-throughput assessment of candidate gene expression and data modeling constructed with a tissue microarray apparatus and 0.6-mm biopsy cores, representative of tumor grades and scores (Gleason Grades 3 (GG3) and Gleason Grade 4 (GG4)). The percentage of tumor cells exhibiting detectable staining, scored as 0 to 10 where higher score designates more involvement, as applicable for: vascular epithelial growth factor (VEFG), estrogen receptor beta (ERβ), androgen receptor (AR), 3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), ubiquitin-conjugating enzyme E2C (UBE2C), and Cleaved Caspase 3 (Caspase). P values are based on non-parametric Wilcoxon rank-sum test.|At prostatectomy following maximum 6 week treatment period|Of total 183 enrolled participants in both arms, 62 Finasteride and 68 Placebo participants respectively had a qualifying tumor specimen with GG3 or GG4. Differences in number (N) of tissue specimens (tumor foci) is based on feasibility of subgroup participants' radical prostatectomy samples analyzed.||Percentage tumor cell involvement||Full Range|Median
143759|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estradiol (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
143760|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Estrone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood test used to measure Estrone (E1), one of the three estrogens, which also includes estriol and estradiol.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
143761|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Dihydrotestosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Dihydrotestosterone (DHT) blood test measures serum concentrations of dihydrotestosterone and is closely related to those of testosterone.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
143762|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Testosterone (ng/dL) Percentage Change|Characteristics of blood biomarkers using pretreatment and posttreatment values. Blood tests used for measuring the amount of testosterone in the blood.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
143763|NCT00438464|Secondary|Characteristics of Blood Biomarkers: Prostate-specific Antigen (ng/mL) Percentage Change (%)|Characteristics of blood biomarkers using pretreatment and posttreatment values. Prostate-specific antigen (PSA) blood test measuring protein produced by prostate cells.|Baseline biopsy to prostatectomy following maximum 6 week treatment period|Analysis includes all evaluable participants.||percentage of change||Full Range|Median
143766|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin -- Dominant Tumor Focus|Dominant tumor focus, distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone. Dominant tumor focus is the largest, index lesion, single high risk focus of the prostate cancer.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
143767|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Zonal Origin of Tumor Foci Per Radical Prostatectomy Specimen (RPS)|Tumor distribution within zones of the prostate using radical prostatectomy specimen (RPS) where number of foci categorized by zone defined as: PZ, peripheral zone; TZ, transition zone; CZ, central zone.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
143768|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Cancer Foci|Diagnosis of a small focus of prostatic adenocarcinoma on a prostate needle biopsy from pathologist's identification of an architecturally abnormal focus of epithelial structures at rather low magnification.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
143769|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Lymph Node Status|Status of cancer spread to lymph nodes; PN0 Cancer that has not spread to the lymph nodes. Cancer that has not spread to the lymph nodes. The N category describes whether the cancer has spread into nearby lymph nodes. NX means the nearby lymph nodes cannot be evaluated. N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
143770|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Margin of Resection (MOR)|Edge or border of tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants.||participants|||Number
143771|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Tumor, Node, Metastasis (TNM) Stage|American Joint Committee on Cancer (AJCC) system 6th edition (2002) describing amount and spread of cancer body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Numbers after the T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues where T3a reflects tumor has spread through the capsule on one or both sides; and T3b reflects tumor has invaded one or both seminal vesicles.|Assessment following maximum 6 week treatment period and prostatectomy|All evaluable participants.||participants|||Number
143772|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Secondary)|Frequency of Grade 3, Grade 4 and Grade 5 tumors in two treatment groups: Participants will consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.||participants|||Number
143773|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Grade -- Specimen (Primary)|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of the prostate, clinical stage T1c or T2, with a Gleason score of 6 or 7 and a PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.||participants|||Number
143774|NCT00438464|Secondary|Pathologic Characteristics of Radical Prostatectomy Specimens After Treatment: Gleason Score|Frequency of Grade 3 and Grade 4 tumors in two treatment groups: Participants consist of men with adenocarcinoma of prostate, clinical stage T1c or T2, with Gleason score of 6 or 7 and PSA level < 10 ng/mL, who are scheduled to undergo prostatectomy. 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) used to grade tumors based upon its microscopic appearance: a primary grade is assigned to most common tumor pattern, and a second grade to next most common tumor pattern. Gleason score (GS) is sum of the two Gleason grades, based on scale of 2-10 with lowest numbers indicating slow-growing tumor unlikely to spread and highest numbers indicating an aggressive tumor. Gleason grade = 1-5; Gleason score = 2-10; 5 and 10 indicate worst prognosis. American Joint Committee on Cancer (AJCC) staging describes extent of disease progression utilizing TNM scoring system: Tumor size, Lymph Nodes affected, Metastases. Higher stage cancers are more advanced.|Assessment following maximum 6 week treatment period and prostatectomy|Analysis includes all evaluable participants. One participant in each arm was excluded due to hormonal therapy effect resulting in lack of assignment of Gleason Grade.||participants|||Number
143775|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)|"Evaluation of Changes~Changes in the EpiTrack® Score were categorized as follows:~≥5 score points: Improved;~-3 to 4 score points: Unchanged;~≤-4 score points: Worsened"|week 58|Patients of ITT population with data at V6 and V0||participants|||Number
143776|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6|"Evaluation of current testing at V6:~≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;~≤25 score points: Impaired"|58 weeks|Patients of ITT population with data at V6||participants|||Number
143986|NCT00436345|Secondary|Duration of Extubation|Duration of extubation was measured.|up to 38 days (912 hours)|ITT Population. Only participants with available extubation data were analyzed.||hours||Standard Deviation|Mean
143777|NCT00438451|Secondary|Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6|EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45.|week 58|Patients of ITT population who had data at V6||units on a scale||Standard Deviation|Mean
143778|NCT00438451|Secondary|Portland Neurotoxicity Scale (PNS) at V6|"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.~Lower values indicate better quality of life."|at week 58|Patients of ITT population who filled out PNS at V6||units on a scale||Standard Deviation|Mean
143779|NCT00438451|Secondary|QOLIE-31 (Quality Of Life In Epilepsy) Results at V6|The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100.|58 weeks, final visit|Patients of ITT population who filled out QOLIE-31 at V6||units on a scale||Standard Deviation|Mean
143780|NCT00438451|Secondary|Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase||52 weeks|Patients of ITT population who reached the maintenance phase||proportion of seizure-free days|||Number
143781|NCT00438451|Secondary|The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)|"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.~The absolute seizure frequency during the maintenance phase was defined as the sum of those entries."|over 52 weeks|"Completer population:~The completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment)."||number of seizures|||Number
143782|NCT00438451|Secondary|The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)||over the whole duration of 58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||days||95% Confidence Interval|Median
143783|NCT00438451|Secondary|Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)|Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58.|week 58|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||percentage of participants|||Number
143784|NCT00438451|Secondary|Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)|Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30.|Week 30|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||percentage of participants|||Number
143785|NCT00438451|Secondary|Time to Drop Out|number of days between randomization and premature discontinuation of the study|58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||days||95% Confidence Interval|Median
143786|NCT00438451|Primary|58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment||58 weeks|"ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements."||proportion of participants||95% Confidence Interval|Mean
143787|NCT00438399|Primary|Percentage of Subjects Preffering Clobetasol Propionate Shampoo Better Than Comparator|"Subjects’ Overall preference at the end of Period II. The purpose was to demonstrate a superiority of Clobetasol propionate shampoo 0.05% therapy compared to any of three other topical comparators, in terms of subject's overall preference: C. propionate shampoo a lot better than the comparator,C. propionate shampoo a lillte bit better than the comparator, Comparator a lot better than C. propionate shampoo, Comparator a lillte bit better than C. propionate shampoo. This was to be shown using a non parametric two-sided Wilcoxon rank Signed test, on Intention to Treat (ITT) population."|End of period II (up to 16 weeks)|Intent to Treat population (ITT).||Percentage of participants|||Number
143788|NCT00438360|Secondary|Safety / Tolerability Assessed by Adverse Events||24weeks||||||
143789|NCT00438360|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline and week 24|Intent to treat (ITT) population. Patients with a value of VAS at baseline and 24 weeks were included in this analysis.||Units on a scale||Standard Deviation|Mean
143790|NCT00438360|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( [Height(in) x Weight(lbs) ]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed|Baseline and week 24|Intent to Treat (ITT) population. Patients with a value of BSA at baseline and 24 weeks were included in this analysis.||BSA (m^2)||Standard Deviation|Mean
143983|NCT00436345|Secondary|Duration of Propofol Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Propofol were analyzed.||hours||Standard Deviation|Mean
143791|NCT00438360|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree.|baseline and week 24|Intention to treat (ITT) population. Patients with a value of PASI at baseline and 24 weeks were included in this analysis.||Units on a scale||Standard Deviation|Mean
143792|NCT00438360|Secondary|Proportion of Participants With Clinical Relapse|Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) >75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.|24 weeks|Intent to treat population.||proportion of participants|||Number
143793|NCT00438360|Primary|Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score|PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score >75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was >= 75%. In all the other cases the patient was considered as success (no relapse).|24 weeks|Intent to treat population.||Participants|||Number
143794|NCT00438204|Secondary|Overall Survival||Every 8 weeks, for up to 54 months||||||
143795|NCT00438204|Secondary|Time to Treatment Failure||Every 8 weeks, for up to 54 months||||||
143796|NCT00438204|Secondary|Toxicity||Every two weeks, for up to 54 months||||||
143797|NCT00438204|Secondary|Response Rate||Every 8 weeks, for up to 54 months||||||
143798|NCT00438204|Primary|Progression-free Survival (PFS)|RECIST criteria for tumor progression of at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|Up to 12 months|||months||90% Confidence Interval|Median
143799|NCT00438100|Secondary|Survival Rate||The follow up period will be two years after the last dose has been administered.||||||
143800|NCT00438100|Secondary|Time to Treatment Failure||The follow up period will be two years after the last dose has been administered.||||||
143801|NCT00438100|Secondary|Antitumor Effects||The follow up period will be two years after the last dose has been administered.||||||
143802|NCT00438100|Secondary|Adverse Events||The follow up period will be two years after the last dose has been administered.||||||
143803|NCT00438100|Primary|Progression Free Survival||The follow up period will be two years after the last dose has been administered.|||years||95% Confidence Interval|Median
143804|NCT00437983|Secondary|Change From Baseline in Rey Osterrieth Complex Figure Test|A widely used neuropsychological tool for the evaluation of visuospatial constructional ability and visual memory. Both the time to complete the task (copy time)and the accuracy (immediate and delayed recall) were used as measures for the analysis. Accuracy range score is 0-36 points (0 is worse, 36 is best). Copy time is expressed in seconds (less time to copy indicates better performance).|baseline, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).||Units on a scale||Standard Error|Mean
143805|NCT00437983|Secondary|Clinical Global Impression of Change (CGI-C)Scale|The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician’s global impression of change. Global improvement score ranges from 1 = “Very much improved”, through 4 = “No change”, to 7 = “Very much worse”. Participants who experienced an improvement (scores 1, 2 or 3) in at least one of the two visits (following 7 or 15 weeks of treatment) were classified as improved over the treatment period (with the exception of participants reporting improvement following 7 weeks and deterioration at endpoint, who were NOT rated as improved)|7 weeks, 15 weeks|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn't meet the compliance criteria (≥ 65%).||Participants who experienced improvement|||Number
143806|NCT00437983|Secondary|Computerized Cognitive Assessment Tool||baseline, 15 weeks||||||
143807|NCT00437983|Secondary|Trail Making Test||Baseline, 15 weeks||||||
143808|NCT00437983|Secondary|Blood Work||baseline,15 wk||||||
143809|NCT00437983|Primary|Change From Baseline in Rey Auditory Verbal Learning Test|A widely used, brief, easy to understand scale to evaluate verbal learning and memory. The score is presented as the number of words correctly recalled (0 is worse, 15 is best).The total learning task score ranges from 0 to 45 words(0 is worse, 45 is best).|baseline, 15 wk|Analysis of per-protocol (PP) cohort. Out of the 131 participants who completed the study, nine were excluded from the PP analysis (5 from the placebo group and 4 from the PS-omega3 group), one due to short interval between visits and the rest didn’t meet the compliance criteria (≥ 65%).||number of words correctly recalled||Standard Error|Mean
143810|NCT00437645|Secondary|Percentage of Patients Achieving a Systolic Response at Weeks 4, 8, and 12|Systolic response was defined as msSBP < 130 mmHg or at least a 20 mmHg reduction from baseline in msSBP at Weeks 4, 8, and 12. Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||Percentage of patients|||Number
151578|NCT00373360|Secondary|Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
143811|NCT00437645|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP, msDBP) From Baseline to Weeks 4, 8, and 12|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Weeks 4, 8, and 12|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||mmHg||Standard Error|Least Squares Mean
143812|NCT00437645|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||mmHg||Standard Error|Least Squares Mean
143813|NCT00437645|Primary|Percentage of Patients With Peripheral Edema From Baseline to Week 8|Only occurrences of peripheral edema quantified as a reported adverse event coded as peripheral edema were included in the analysis. If a patient experienced more than one occurrence of peripheral edema between Day 1 and Week 8, it was only counted once in the analysis.|Baseline to Week 8|Safety population: All randomized patients.||Percentage of patients|||Number
143814|NCT00437645|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0. 5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who had a baseline and at least one post-baseline efficacy assessment. For patients who discontinued prior to Week 8, the last post-baseline msSBP measurement collected was used for the analysis (last observation carried forward [LOCF]).||mmHg||Standard Error|Least Squares Mean
143815|NCT00437489|Secondary|Hypoglycemia Event Rate Per Month|Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).|up to week 4 or 16|FAS Population||event rate per month||Standard Deviation|Mean
143816|NCT00437489|Secondary|Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia|Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.|week 16|FAS Population - Descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.||participants|||Number
143817|NCT00437489|Primary|Change in HbA1c From Baseline|Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16|From baseline to week 16|Full analysis set (FAS) population - descriptive statistics were produced using last observation carried forward (LOCF) for Week 16, therefore all subjects are included in the Week 16 data.||Percent||Standard Deviation|Mean
143818|NCT00437489|Secondary|Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)|Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.|From baseline to week 16|FAS - descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data.||mmol/l||Standard Deviation|Mean
143819|NCT00437398|Secondary|Mean Glycated Hemoglobin (HbA1c) Since Transplant|HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well the subject is controlling his/her diabetes.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.|||||
143820|NCT00437398|Primary|Mean Number of Hypoglycemic Events After Transplant|Hypoglycemia is an abnormally diminished content of glucose in the blood.|3, 6, 9, and 12 months since islet transplantation|The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.|||||
143821|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Day 8 up to 28 days after open-label dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.||adverse events|||Number
143822|NCT00437281|Secondary|Renal Clearance (CLr): Single-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are only reported for pregabalin 15 mg/kg/day, 7 to 11 years and pregabalin 5 mg/kg/day, 12 to 16 years because none of the participant had PK parameter available in rest of the groups.||mL/min||Geometric Coefficient of Variation|Geometric Mean
143823|NCT00437281|Secondary|Renal Clearance (CLr): Multiple-Dose Analysis|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for some of the groups since none of the participant had PK parameter available in these groups.||mL/min||Geometric Coefficient of Variation|Geometric Mean
143824|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Single-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||mL/min||Geometric Coefficient of Variation|Geometric Mean
143825|NCT00437281|Secondary|Apparent Oral Clearance (CL/F): Multiple-Dose Analysis|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
143826|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Single-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||hours||Standard Deviation|Mean
143827|NCT00437281|Secondary|Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Standard Deviation|Mean
143828|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis|Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||hours||Full Range|Median
143829|NCT00437281|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis|Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hours||Full Range|Median
143830|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis|Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
143831|NCT00437281|Secondary|Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis|Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||(microgram/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
143832|NCT00437281|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8|PK parameter analysis population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Results are not reported for pregabalin 10 and 15 mg/kg/day for 12 to 16 age cohort since none of the participant had PK parameter available in these groups.||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
143833|NCT00437281|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis|Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose.|Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period (double-blind or open label treatment). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||(microgram*hour/milliliter)/(mg/kg)||Geometric Coefficient of Variation|Geometric Mean
143834|NCT00437281|Secondary|28-Day Seizure Frequency Rate|Seizure frequency was reported by participant's parent or guardian from randomization to 7 days post-last dose of study medication. 28-day seizure frequency rate = (number of seizures in observation period/number of days in observation period)*28.|Baseline up to 7 days post-last dose of study medication|Results are not reported since the data was reported in individual participant listings but not summarized for analysis.|||||
143835|NCT00437281|Primary|Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment|Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE.|Baseline to Day 7|Safety analysis set included all participants who received at least 1 dose of study medication.||adverse events|||Number
143836|NCT00437281|Secondary|Number of Participants With Clinically Significant Change in Physical and Neurological Findings|Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator.|Baseline up to 7 days post-last dose of study medication|Safety analysis set included all participants who received at least 1 dose of study medication.||participants|||Number
143837|NCT00437203|Secondary|Metabolite Profile of PF-00477736 in Plasma and Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||percentage of recovered metabolite|||Number
143838|NCT00437203|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||hr||Standard Deviation|Mean
143839|NCT00437203|Secondary|Concentration of PF-00477736 in Urine||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng/mL||Standard Deviation|Geometric Mean
143840|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng*hr/mL||Standard Deviation|Geometric Mean
143841|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]|AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).|0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng*hr/mL||Standard Deviation|Geometric Mean
143842|NCT00437203|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0|Data was not analyzed, as study was terminated due to business reasons.||ng*hr/mL||Standard Deviation|Geometric Mean
143843|NCT00437203|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||hr||Full Range|Median
149268|NCT00394771|Secondary|Days With Bleeding During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||days||Full Range|Median
143844|NCT00437203|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng/mL||Standard Deviation|Geometric Mean
143845|NCT00437203|Secondary|Maximum Observed Plasma Concentration (Cmax)||0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10|Data was not analyzed, as study was terminated due to business reasons.||ng/mL||Standard Deviation|Geometric Mean
143846|NCT00437203|Secondary|Number of Participants With Objective Response (OR)|OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.|Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62|FAS included all enrolled participants who received at least 1 dose of study medication.||participants|||Number
143847|NCT00437203|Primary|Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine||Up to Day 21 Cycle 1|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study medication.||mg|||Number
143848|NCT00437125|Secondary|Number of Participants Who Reached Remission by 12 Weeks|Remission was defined as reaching a 17-item Hamilton Depression Rating Scale (HAMD) total score <=7. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||participants|||Number
143849|NCT00437125|Secondary|Number of Participants Who Responded to Treatment by 12 Weeks|Response was defined as a >= 50% reduction in 17-item Hamilton Depression rating scale (HAMD) scores. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||participants|||Number
143850|NCT00437125|Secondary|Laboratory Analytes|Laboratory analytes were collected to assess adverse events which are listed in the reported adverse events section.|baseline through 12 weeks|All enrolled participants for whom both baseline data and post-baseline data were available were included in the analyses.||participants|||Number
143851|NCT00437125|Secondary|Number of Participants With Abnormal Electrocardiograms (ECG) During the 12 Week Study|Included were participants with normal ECG at baseline who developed abnormal ECGs during the study.|baseline through 12 weeks|All treated participants were included in the analysis population. 54 participants were excluded from calculation of change as they had abnormal ECG at baseline, no baseline measure, or no post-baseline measure.||participants|||Number
143852|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Heart Rate|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 6 participants were excluded from calculation of change as they had either no baseline or post-baseline measure.||beats per minute||95% Confidence Interval|Mean
143853|NCT00437125|Secondary|Average Change From Baseline to 12 Weeks in Blood Pressure|For each participant, changes across individual visits were averaged to obtain 1 measurement per participant.|baseline through 12 weeks|All treated participants were included in the analysis population. 5 participants for standing measurement and 6 participants for supine measurements were excluded from calculation of change as they had either no baseline or no post-baseline measure.||millimeter mercury||95% Confidence Interval|Mean
143854|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Parkinson Disease Questionnaire - 39 Item Version (PDQ-39) Total Score|The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale.|baseline, 12 weeks|All treated participants with both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with no baseline measure and 29 participants with no post baseline measure.||units on a scale||Standard Deviation|Mean
143855|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Visual Analog Scale (VAS)|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Here, the line was only 93 mm long due to an error on the clinical research form and scores were adjusted to 0 to 93.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least 1 efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. Excluded were 2 participants with only post-baseline data and 1 participant with only baseline data.||units on a scale||Standard Deviation|Mean
143876|NCT00437034|Secondary|Circulating Endothelial Progenitors|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year||||||
143856|NCT00437125|Secondary|Change From Baseline to 12 Weeks in Beck Depression Inventory (BDI) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis. 27 participants had no post baseline measure.||units on a scale||Standard Deviation|Mean
143857|NCT00437125|Secondary|Patient's Global Impression-Improvement at Week 12|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. Scoring: 1=very much better; 2=much better; 3=low better; 4=no change; 5=low worse; 6=much worse; 7=very much worse.|12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses.||participants|||Number
143858|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Clinical Global Impression-Severity Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||units on a scale||Standard Deviation|Mean
143859|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline, 12 weeks|All treated participants for whom both baseline data and post-baseline data for at least 1 visit for at least one efficacy variable were available (Full analysis set population) were included in the analyses. Last observation carried forward analysis.||units on a scale||Standard Deviation|Mean
143860|NCT00437125|Secondary|Change From Baseline on the Pittsburgh Sleep Quality Index (PSQI)|Self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The subject self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The total score is the sum of the 7 component scores (total score range: 0-21).|baseline, 4 weeks, 8 weeks, 12 weeks|All treated participants with baseline and post-baseline data for >= 1 visit for >= 1 efficacy variable were included in the analyses (Full Analysis Set population). Last observation carried forward analysis. Excluded 2 participants (no baseline measure of PSQI) and 13 participants from calculation of change (absence of any post-baseline measure).||units on a scale||Standard Deviation|Mean
143861|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale|Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales: psychic (score range:0-30), neurological (score range:0-24), autonomic (score range:0-33), other (score range:0-75), global assesment by subject (score range:0-3), and global assessment by doctor (score range:0-3). Higher ratings indicate greater impairment.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. One participant was excluded as no data for UKU were available and other participants were excluded as relevant due to absence of either baseline or post-baseline measure.||units on a scale||Standard Deviation|Mean
143862|NCT00437125|Secondary|Change From Baseline to 12 Weeks on the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Rating tool to follow the longitudinal course of Parkinson's Disease. It is composed of Section I: Mentation, Behavior, and Mood; Section II: Activities of Daily Living; Section III: Motor Examination; Section IV: Complications of therapy. These are evaluated by interview. Some sections require that multiple grades be assigned to each extremity. Only Sections II and III were rated in this study. A total of 160 points are possible (52 in Section II and 108 in Section III), where 0 represents no disability and 160 indicates maximal grade of disability.|baseline, 12 weeks|All treated participants were included in the analysis population. Last observation carried forward analysis. Two participants were excluded from calculation of change as they had no post-baseline measure.||units on a scale||Standard Deviation|Mean
143863|NCT00437125|Primary|Number of Participants Reporting Serious Adverse Events or Other Adverse Events Leading Either to Discontinuation or to Death|The results reported are the number of participants who discontinued the study as a result of an adverse event (serious or other) or death.|baseline through 12 weeks|All treated participants.||participants|||Number
143864|NCT00437073|Secondary|Percentage of Participants With a >=20% Volumetric Reduction in CNS Lesions|The percentage of participants with a >=20% volumetric reduction in CNS lesions was defined as the percentage of treated participants achieving at least a 20% volumetric reduction in CNS lesions relative to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|Baseline; from the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143865|NCT00437073|Secondary|Percentage of Participants With Disease Stabilization for 6 Months or More|The percentage participants with disease stabiliztion for 6 months or more were defined as those treated participants with a best CNS objective response of SD whose disease stabilization lasted 6 months or more from the start of treatment. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143866|NCT00437073|Secondary|Percentage of Participants With Baseline Tumor-related (TR) Neurological Signs and Symptoms (NSS), Who Experienced Improvement in NSS as Measured by the Neurological Examination Worksheet (NEW)|TR NSS was to be recorded by the Investigator on the NEW, using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE V3.0). Improvement was to be defined as a decrease of 1 or more CTCAE grades from baseline of any TR NSS. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143867|NCT00437073|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143868|NCT00437073|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment until the first documented sign of disease progression at any site or death due to any cause, if sooner. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143869|NCT00437073|Secondary|Number of Participants With the Indicated Site of Initial Disease Progression|The site of initial disease will be determined by taking the earliest date of known progression and assigning the appropriate category (CNS or non-CNS) based on the source of the earliest date. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143870|NCT00437073|Secondary|Time to CNS Objective Response (Defined as the Time From the Start of Treatment Until the First Documented Evidence of Partial or Complete Tumor Response [Whichever Status is Recorded First])|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143871|NCT00437073|Secondary|Percentage of Participants (Par.) With Objective Response by RECIST in Non-CNS Disease|Non-CNS disease (for par. with measurable baseline non-CNS disease) OR is defined as the number of par. with either a CR or PR as assessed by computed tomography (CT) or MRI scan and RECIST. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough par. enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143872|NCT00437073|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR (complete resolution of all evaluable and non-evaluable brain metastases), PR (=>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline), or stable disease (disease that does not meet CR, PR, or CNS progression criteria) for at least 6 months. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143873|NCT00437073|Secondary|Duration of CNS Objective Response (Defined as the Time From the First Documented Evidence of CNS PR or CR Until the First Documented Sign of Disease Progression or Death, if Sooner)|CNS OR is defined as the number of participants with either a CR or PR as assessed by volumetric analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline. This study was closed before full enrollment was achieved; thus, predefined secondary efficacy endpoints were not assessed because there were not enough participants enrolled in the study to provide statistically valid analyses.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population|||||
143874|NCT00437073|Primary|Number of Participants With the Indicated CNS Responses|"CNS responses were assessed by volumetric (V) analysis of brain MRI and RECIST. CR: complete resolution of all evaluable and non-evaluable brain metastases (BMs). PR: =>50% reduction in the V sum of all evaluable BMs compared to baseline. A response of Other was used for participants who discontinued the study prior to the first efficacy assessment. Stable Disease (SD): disease that does not meet CR, PR, or CNS progression criteria. Progressive disease (PD): a requirement for a new steroid or an increasing steroid dose for the treatment of worsening neurological signs/symptoms due to BMs."|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|mITT Population||participants|||Number
143875|NCT00437073|Primary|Number of Participants With the Indicated Central Nervous System (CNS) Objective Response (OR)|CNS OR is defined as the number of participants with either a complete response (CR) or partial response (PR) as assessed by volumetric analysis of brain magnetic resonance imaging (MRI) and Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline.|From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88|Modified Intent-to-Treat (mITT) Population: all participants who had at least one evaluable CNS target lesion at baseline and who had received at least two doses of lapatinib medication||participants|||Number
143877|NCT00437034|Secondary|Proangiogenic Factors Such as VEGF|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline, before every course for 3 months, and then every 3 months during treatment for the first year||||||
143878|NCT00437034|Secondary|The Apoptotic State of Tumor Neovasculature|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)||||||
143879|NCT00437034|Secondary|Tissue Expression Patterns of VEGFR Subtypes|The change in the prevalence/expression of these markers between pre-and-post treatment samples will be analyzed by McNemar’s test. Ninety-five percent confidence intervals will be calculated to assess the precision of the obtained estimates for all laboratory correlates.|At baseline and post-treatment (1 week after 2nd dose and end of study)||||||
143880|NCT00437034|Secondary|Toxicities|Toxicities will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0 terminology. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.|During treatment and follow up||||||
143881|NCT00437034|Secondary|Overall Survival (OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until death, assesseduUp to 6 months||||||
143882|NCT00437034|Secondary|Progression-free Survival (PFS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until objective or symptomatic progression, assessed up to 6 months||||||
143883|NCT00437034|Primary|Overall Response Rate (Complete [CR] and Partial Response [PR])|"A 95% confidence interval was intended to be estimated via binomial proportions, but was not computed due to small sample size.~Criteria for Response from EBMT, IBMTR, ABMTR: Complete Response:Complete absence of monoclonal protein by immunofixation for a minimum of 6 weeks; Near Complete Response:Absence of serum paraprotein by standard serum/urine protein electrophoresis without disappearance of monoclonal spike by immunofixation; Partial Response:Sustained decrease in production rate of monoclonal serum protein to 50% or less of pretreatment value; Stable Disease: No significant change from baseline; Progression of Disease:Patients with a > or = 25% rise in production rate, new/increased size of lytic lesions/plasmacytomas/progressive marrow plasmacytosis; Symptomatic Deterioration:Patients with deterioration of health requiring discontinuation of treatment w/out objective evidence of disease progression."|At baseline and every 4 weeks during study treatment until treatment discontinuation due to disease progression, unacceptable toxicities and/or patient withdrawal.|||participants|||Number
143884|NCT00436982|Secondary|The Objective is to Investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric Behaviour and Patient Outcome in a Prospective Randomized Clinical Trial.|"Plain radiographs for disease class. Clinical assessment AKSS and KOOS score. Post operative FU all plain radiographs for assessment of the component position.~Yearly radiographic FU to assess wear, radiolucent zones and stress resorption and patella sky view projection."|3 months, 1, 2, 5, 7 and 10 years||||||
143885|NCT00436982|Primary|Roentgen Stereophotogrammetric Analysis (RSA)|To compare the maximum total point motion of the Triathlon and Duracon tibial components after two years assessed by means of RSA.|2 years|||mm||Standard Deviation|Mean
143886|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143887|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
143888|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143935|NCT00436644|Secondary|Adverse Event Profile|Number of patients that experienced adverse events (grade 3 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 4 weeks|||participants|||Number
143889|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Mental score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
143890|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143891|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
143892|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143893|NCT00436969|Secondary|12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in 12-Item Short Form Survey (SF-12) Physical score calculated as visit score - baseline score.~The SF-12 is a generic measure and does not target a specific age or disease group. It has been developed to provide a shorter, yet valid alternative to the SF-36, which has been seen by many health researchers as too long to administer to studies with large samples. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health.~Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
143894|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143895|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
143896|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (As Treated)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The As Treated analysis population included all subjects that received treatment and had outcome data.||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
143897|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143898|NCT00436969|Secondary|Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in Shoulder Pain and Disability Index (SPADI) Total Disability score calculated as visit score - baseline score.~The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain, where: 0 = no pain and 10 = the worst pain imaginable. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use, where: 0 = no difficulty and 10 = so difficult it requires help.~Scoring instructions: The scores from both dimensions are averaged to derive a total score."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
143899|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143900|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||units on a scale||Standard Error|Least Squares Mean
143901|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||units on a scale||Standard Error|Least Squares Mean
143902|NCT00436969|Secondary|American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)|"The difference in American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient score calculated as visit score - baseline score.~The ASES was designed to provide a standard method for evaluation of the shoulder through assessment of pain and activities of daily living (ie, function). The ASES is derived from an equation that incorporates a visual analog pain scale and functional ability questions. Both components have a maximum score of 50. Pain is calculated by subtracting the visual analog score from 10 and then multiplying by 5 for a total of 50 points. The function component is calculated by adding the points and multiplying by five thirds for a maximum of 50 points. The subscores for pain and function are then added for the total score. The maximum possible total score is 100, representing less pain and greater function."|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||units on a scale||Standard Error|Least Squares Mean
143903|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~The difference in pain was calculated as visit score - baseline score."|Baseline and 12 weeks|The As Treated analysis population included all subjects that received treatment and had outcome data.||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
143904|NCT00436969|Secondary|Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)|The difference in pain was calculated as visit score - baseline score. Scores are measured on a 100 mm visual analogy scale.|Baseline and 12 weeks|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation. Subjects were allowed to have missing interim visits (i.e. 12 weeks).||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
143905|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The As Treated analysis population included all subjects that received treatment and had outcome data.||Percentage of Participants||95% Confidence Interval|Number
143906|NCT00436969|Secondary|Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)|"Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.~A responder was defined as a 20 mm or greater reduction in VAS pain score from baseline to 6 months."|Baseline and 6 months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||Percentage of Participants||95% Confidence Interval|Number
143907|NCT00436969|Primary|Visual Analog Scale (VAS) Pain Score (Per Protocol)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|6 Months|The Per Protocol analysis population was defined as all subjects that received treatment and completed 6 months of follow-up without a major protocol deviation.||mm on a 100 mm VAS scale||Standard Error|Least Squares Mean
143908|NCT00436956|Secondary|Number of Grade 3 Toxicities|Here is the number of Grade 3 (severe) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.||toxicities|||Number
143909|NCT00436956|Secondary|Number of Grade 2 Toxicities|Here is the number of Grade 2 (moderate) toxicities.|61.5 months|Only 58 participants were evaluable for toxicity.||toxicities|||Number
143910|NCT00436956|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|61.5 months|||participants|||Number
143911|NCT00436956|Primary|Percentage of Participants With 6-month Progression-free Survival (PFS)|PFS is the proportion of subjects who progress or die by 6 months after the start of the combined therapy. PFS is determined by prostatic specific antigen (PSA) consensus criteria and the Response Evaluation Criteria in Solid Tumors (RECIST). PSA consensus criteria is defined as PSA decline of >/= 50% or PSA progression. RECIST is defined as the following: Complete response (CR) is disappearance of all target lesions; partial response (PR) is at least a 30% decline in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease ((PD) at least a 20% increase in the sum of the LD of target lesions, or the appearance of one or more lesions), taking as reference the smallest sum LD since the treatment started.|6 months|One participant was not evaluable owing to the development of a cord compression on day 2 of therapy and was subsequently removed from the trial. Since the prednisone was added to relieve toxicity & outcome data is based on response, the cohorts were analyzed together in terms of response. No suggestion prednisone significantly altered outcomes.||percentage of participants|||Number
143912|NCT00436917|Secondary|Time to Disease Progression||5 yr||||||
143913|NCT00436917|Secondary|Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0||5 yr||||||
143914|NCT00436917|Secondary|Femoral Neck BMD as Measured by DXA at Baseline and at 12, 24, 36, 48, and 60 Months||5 yr||||||
143915|NCT00436917|Secondary|Total Lumbar Spine BMD as Measured by DXA at Baseline and at 24, 36, 48, and 60 > Months||5 yr||||||
143916|NCT00436917|Primary|Average Intra-patient Change in Total Lumbar Spine (L1 to L4) Bone Mineral Density (BMD)|Change: BMD values at twelve months post study entry minus BMD values at baseline, expressed as a percentage of the baseline value.|Baseline and 1 year|The primary analysis is performed on data where participants had the same baseline and 1 year BMD Lumbar Spine measurement location (L1-L4, L2-L4 or ‘other Lumbar Spine’)||Percentage of the baseline value||95% Confidence Interval|Mean
143917|NCT00436904|Secondary|Time to Disease Progression|Calculated from date of registration to date of disease progression. In patients that have not progressed, time to disease progression will be censored at the patient's last evaluation date.|Time from registration to progression (up to 5 years)|||Months||95% Confidence Interval|Median
143918|NCT00436904|Secondary|Survival|Survival is calculated from the date of registration to the date of death due to any cause. In patients who are still alive, survival will be censored at the last date when the patient was known to be alive.|Death or last follow-up (up to 5 years)|At analysis time, only 1 out of 30 patients had died. Thus, median survival was not attainable.||Months||95% Confidence Interval|Median
143919|NCT00436904|Secondary|Duration of Response|Duration of response is calculated from the date of documented response until the date of progression in the subset of patients who respond to treatment. In patients who have not yet progressed, duration of response will be censored at the patient's last evaluation date.|Up to 5 years|Patients that responded were included in the analysis.||Months||95% Confidence Interval|Median
143920|NCT00436904|Secondary|Time to Response|Calculated from the date of registration until the first date at which the patient's objective status was classified as a response. In patients who do not achieve a response, time to response will be censored at the patient's last evaluation date. Response is defined the same way as in the response primary outcome measure.|Registration to first response (up to 5 years)|||Days||95% Confidence Interval|Median
143921|NCT00436904|Primary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. >~> Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration|||participants|||Number
143922|NCT00436904|Primary|Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months|Confirmed response is defined as a > 50% decrease in clinical symptoms from baseline and recovery from blood counts.|Up to 6 months|Number of patients with a confirmed response out of total patients evaluable for response.||participants||95% Confidence Interval|Number
143923|NCT00436852|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Toxicity will be tabulated by grade (overall and by course).|yearsFrom enrollment until 30 days after the end of protocol therapy||||||
143924|NCT00436852|Secondary|Quality of Life Measured by PedsQL™ Generic Core Scale Version 4.0|For each of the items within a Dimension, the QOL score will be reverse linearly transformed to a 0-100 percentage point scale (0=100, 1=75, 2=50, 3=25, 4=0), and the average of all items within a Dimension will be calculated. This results in 4 definitive scores at each timepoint. The average of all 23 items will be the Total Score at a given timepoint; and, 2) the repeated measures of performance status (Karnofsky score for patients > 16 years of age and Lansky score for patients ≤ 16 years of age).|3 weeks||||||
143925|NCT00436852|Secondary|Objective Response Rate|The proportion of patients who are responders will be tabulated, including a 95% confidence interval on the proportion.|Duration of protocol therapy||||||
143926|NCT00436852|Primary|1-year Progression-free Survival|PFS probabilities calculated using the Kaplan-Meier method, along 95% confidence intervals, separately for each stratum.|From the day of enrollment to the date of disease progression/recurrence , or the date of death (all causes of mortality) if disease progression/recurrence is not reached, assessed up to 1 yr. Pts were to be followed for 5 yrs after completion of therapy|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).||percent probability||95% Confidence Interval|Number
143927|NCT00436852|Primary|Median Time to Progression as Assessed by Response Evaluation Criteria in Solid Tumors|Median time to progression observed on ABT-751, along with 95% confidence intervals.|From time to enrollment to death due to any cause, assessed up to 5.1 years|The protocol-specified definition of evaluability was applied. This was not an intention-to-treat analysis because patients who did not receive study drug were excluded (inevaluable).||days||95% Confidence Interval|Median
143928|NCT00436826|Secondary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement. The annualized relapse rate for each treatment group was the mean of the annualized relapse rates for all the participants in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.||relapses per year||95% Confidence Interval|Number
143929|NCT00436826|Secondary|Number of Combined Unique Active (CUA) Lesions, Active Time Constant 2 (T2) Lesions, and Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, active T2 lesions, and T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans|Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.||Lesions||Standard Deviation|Mean
143930|NCT00436826|Secondary|Number of Qualifying Relapses|A qualifying relapse was defined as a 2-grade increase in at least one, or a 1-grade increase in at least two, Kurtzke Functional Systems excluding bowel/bladder or cognition changes, in the absence of fever lasting more than or equal to 24 hours, and preceded by more than or equal to 30 days of clinical stability or improvement.|Baseline up to Week 96|ITT population included all randomized participants who had received at least one dose of study medication in the DB period.||Relapses||Standard Deviation|Mean
143931|NCT00436826|Primary|Percentage of Participants With Adverse Events in Infections and Infestations System Organ Class (SOC)|Adverse Events were entered in infections and infestations SOC as per medical dictionary for regulatory activities (MedDRA) version 11.0|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.||Percentage of participants|||Number
143932|NCT00436826|Primary|Percentage of Participants With Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE]) Hematological or Liver Toxicity|Percentage of participants with Grade 3 or 4 CTCAE toxicity on the following hematology and liver function parameters were reported: lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT) and Aspartate transaminase (AST). According to CTCAE: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.||Percentage of participants|||Number
143933|NCT00436826|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline up to Week 96|Safety population included all randomized participants who received at least one dose of study medication in the DB period and had follow-up safety data.||Participants|||Number
143934|NCT00436644|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from Registration to Death or last follow-up (up to 3 years)|||months||95% Confidence Interval|Median
143937|NCT00436644|Primary|Response Rate (Complete Response (CR) or Partial Response (PR))|"Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter >= 2cm with conventional techniques or >=1cm with spiral CT~Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.~Non-measurable disease patients:~Decrement in CA125 by > 50%~Improvement in other evaluable disease"|Two consecutive evaluations at least 4 weeks apart|||participants|||Number
143938|NCT00436618|Secondary|Time to Progression|The time to progression is defined as the time from registration to the time of progression. The distribution of time to progression was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||years||95% Confidence Interval|Median
143939|NCT00436618|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from registration to the time of progression or death due to any cause. Progression-free survival was estimated using the method of Kaplan-Meier.~Progression is defined as the following:~CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): >=50% increase in nodes from nadir or >=50% increase in liver/spleen size from nadir.~Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% lymph node increase in SPD of > 1 node or new nodes, or >50% liver/spleen size increase, or > 25% IgM (by SPEP) increase, or lymphocyte morphology transformation to a more aggressive histology.~All Others: New lesions or >=50% lymph nodes."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||years||95% Confidence Interval|Median
143940|NCT00436618|Secondary|Overall Survival|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival was estimated using the method of Kaplan-Meier.|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||years||95% Confidence Interval|Median
143941|NCT00436618|Primary|Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.|"CLL (subset of patients in the Relapsed Indolent Non-Hodgkin Lymphoma group): 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions.~Waldenstrom (subset of patients in the Uncommon Lymphomas group): >50% reduction in serum immunoglobulin M(IgM) levels (by serum protein electrophoresis (SPEP)) during any point while in this study, and no appearance of new lesions.~All others: at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease."|5 years|276 out of 277 were analyzed for response. One patient was excluded because of patient refusal before starting treatment.||percentage of patients in group||95% Confidence Interval|Number
143942|NCT00436605|Primary|Progression-free Survival|Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. A Simon’s optimum two-stage design will be used|Time from start treatment to time of progression, assessed up to 6 months|||weeks||Full Range|Mean
143943|NCT00436605|Primary|Number of Subjects With Objective Response(Partial Response and Complete Response) as Measured by RECIST Criteria|Only those patients who have measurable disease present at baseline, have received at least one course of therapy, and have had their disease re-evaluated will be considered evaluable for response. A Simon’s optimum two-stage design will be used.|After every 8 weeks (or 2 courses), assessed up to 4 weeks after completion of treatment|||participants|||Number
143944|NCT00436566|Secondary|Incidence of Pulmonary Events|Pulmonary events to be included were grade 3 and higher pulmonary adverse events at least possibly related to study treatment, which occur at any time after post-AC treatment is begun, but prior to documentation of a breast cancer recurrence, contralateral breast cancer, secondary primary cancer, non-pulmonary death, or pulmonary death not related to study treatment.|5 years||||||
143945|NCT00436566|Secondary|Quality-of-life||5 years||||||
143946|NCT00436566|Secondary|Comparison of Selected Quality-of-life Questionnaires||5 years||||||
143947|NCT00436566|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years||||||
143948|NCT00436566|Secondary|Disease-free Survival (DFS)|DFS was defined as the time from registration to the earliest date of documentation of any local, regional, or distant recurrence of breast cancer (BC); the development of a contralateral BC or second primary other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast; or death from any cause without the documentation of one of these events. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|5 years||||||
143949|NCT00436566|Secondary|Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF) Between Two Time Points||5 years||||||
143950|NCT00436566|Secondary|Cumulative Incidence (CI) of Cardiac Events|"Evaluable patients included those completed the AC phase of their treatment regimen; with post AC cardiac evaluation indicates they are eligible to begin treatment with PTL; and those have begun their post-AC therapy.~Cardiac events: symptomatic congestive heart failure (CHF), cardiac death and other cardiac events (NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3)"|5 years||||||
143951|NCT00436566|Secondary|Adverse Event Profile as Measured by NCI CTCAE v 3.0|Maximum grade for each type of adverse event will be recorded for each patient.|5 years||||||
143952|NCT00436566|Primary|Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment||6 months|||participants|||Number
143984|NCT00436345|Secondary|Duration of Remifentanil Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days (240 hours)|ITT Population. Only participants infused with Remifentanil were analyzed.||Hours||Standard Deviation|Mean
143953|NCT00436553|Primary|Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 up to Month 11|Full analysis set (FAS) - Only the combination groups were analyzed. The percent of subjects with a ranibizumab treatment-free interval of at least 3 months duration following the Month 2 ranibizumab treatment was calculated using the subjects still in the study at Month 5.||Percent of participants|||Number
143954|NCT00436553|Secondary|Change From Baseline in Central Retinal Thickness at Month 12|Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.|Baseline and Month 12|Full analysis set (FAS), observed data.||micrometer||Standard Deviation|Mean
143955|NCT00436553|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|Full analysis set (FAS), observed data.||Percentage of participants|||Number
143956|NCT00436553|Secondary|Change From Baseline in Total Area of Leakage of the Study Eye at Month 12|Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Baseline and Month 12|Full analysis set (FAS), observed data.||mm^2||Standard Deviation|Mean
143957|NCT00436553|Primary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|The Full analysis set (FAS) consisting of all randomized patients that received at least one application of study drug and had at least one post-baseline assessment for BCVA in the study eye. Last observation carried forward (LOCF) was utilized.||Letters||Standard Deviation|Mean
143958|NCT00436501|Primary|Median Progression-Free Survival (PFS) (Phase II)|Progression-Free Survival was calculated from study entry until documented disease, death or date of last contact.|Time from start of treatment to time of progression, assessed up to 6 years.|||months||95% Confidence Interval|Median
143959|NCT00436501|Secondary|Proportion of Patients With PFS (Phase II)|Progression-free survival (PFS) defined as number of participants out of total in arm that had no disease progression as measured at 6 months. Standard RECIST criteria used to evaluate response and progression. All documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after initial documentation of response. In the absence of new symptoms, response assessment was consistently done after two additional cycles of therapy.|6 months||||||
143960|NCT00436501|Secondary|Frequency and Severity of Adverse Effects of Treatment as Assessed by NCI CTCAE v3.0 (Phase II)||Up to 6 years||||||
143961|NCT00436501|Secondary|Overall Median Duration of Response (Phase II)|Duration of the response from time response is achieved until disease progression is detected. Response assessed following treatment (every 3 weeks) for disease progression. Study duration January 2007 to May 2013, approximately six and half years.|Response assessed following treatment (every 3 weeks), up to 6 years. Study duration January 2007 to May 2013.|Number analyzed represents those Phase II participants with response as documented in Outcome Measure 2.||months||Full Range|Median
143962|NCT00436501|Primary|Overall Objective Response Rate According to RECIST (Phase II)|The percentage of participants in the Phase II arm with an objective response defined as a measurable response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Standard RECIST criteria were followed to evaluate response and progression. All documented responses were required to undergo confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, this response assessment was consistently done after two additional cycles of therapy.|Up to 6 months|||percentage of participants|||Number
143963|NCT00436501|Primary|Median Overall Survival (OS) (Phase II)|Overall survival was defined from the date of study entry until death or date of last contact. Median survival time points calculated in the method of Kaplan-Meier. Standard RECIST criteria followed to evaluate response and progression, and all documented responses required confirmation by imaging, examination, or both, no sooner than 4 weeks after the initial documentation of response. In the absence of new symptoms, response assessment consistently done after two additional cycles of therapy.|Time from start of treatment to time of progression, assessed up to 6 years.|||months||Full Range|Median
143964|NCT00436501|Primary|Number of Participants With Clinical Response (Partial Response or Complete Response) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Frequency of clinical response (partial response or complete response) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance all target lesions; Partial Response (PR): >/= 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >/= 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1+ new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.|Up to 6 months|||participants|||Number
143965|NCT00436501|Primary|Maximum Tolerated Dose of VEGF Trap (Phase I)|Escalating dose levels of VEGF Trap were administered intravenously over three dose levels (2, 4, or 6 mg/kg; one dose every 21 days) to identify the maximum tolerated dose (MTD). The MTD is defined as the highest dose level below which 2 or more patients encounter a dose limiting toxicity (DLT), graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. MTD established on absence of observed DLT(s) in either cycle 0 (single agent) or cycle 1 (combination therapy) of any given dose level.|21 day cycle, up to 3 cycles|||mg/kg|||Number
143966|NCT00436345|Secondary|Pain Intensity From Day 8 to Day 10|“Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Days 8, 9, and 10|mITT Population. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.||points on a scale||Standard Deviation|Mean
151579|NCT00373360|Secondary|Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||minutes||Standard Deviation|Mean
143967|NCT00436345|Secondary|Pain Intensity (PI)|“Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Up to 38 days|ITT Population, according to the participants' status. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.||Points on a scale||Standard Deviation|Mean
143968|NCT00436345|Secondary|Bispectral Index (BIS) for Extubation Period and Post-Extubation Period|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|up to 38 days|mITT Population. The BIS value was recorded only for 2 participants, in the extubation and post-extubation periods.||points on a scale||Standard Deviation|Mean
143969|NCT00436345|Secondary|Bispectral Index (BIS) for Day 5|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Day 5|mITT Population. At Day 5, only one participant remained in the study; the others were already extubated.||points on a scale||Standard Deviation|Mean
143970|NCT00436345|Secondary|Bispectral Index (BIS)|The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Screening through End of Study, up to 38 days|mITT Population. Due to the nonmandatory nature of BIS measure in the clinical practice, some participants did not have all the measures for all days in which they were in the study.||Points on a scale||Standard Deviation|Mean
143971|NCT00436345|Secondary|Number of Participants Analyzed for BIS (Bispectral Index Scale)|Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.|Up to 38 days|mITT Population||participants|||Number
143972|NCT00436345|Secondary|Sedation-Agitation From Day 8 to Day 10|“Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.|Days 8, 9, and 10|mITT Population according to the participants’ status||points on a scale||Standard Deviation|Mean
143973|NCT00436345|Secondary|Sedation-Agitation for Day 7|“Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.|Day 7|mITT Population according to the participants’ status||points on a scale||Standard Deviation|Mean
143974|NCT00436345|Secondary|Sedation-Agitation From Screening Through the End of Study|"Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable."|Up to 38 days|mITT Population, according to the participants’ status||Points on a scale||Standard Deviation|Mean
143975|NCT00436345|Secondary|Number of Participants Analyzed for Sedation – Agitation Scale (SAS) and Pain Intensity (PI) Scale|Data from participants in the study for which the Sedation–Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. “Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. “Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.|Up to 38 Days|mITT Population||participants|||Number
143976|NCT00436345|Secondary|Total Dose of Fentanil Administered - Bolus|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Fentanil were analyzed.||ug/kg||Standard Deviation|Mean
143977|NCT00436345|Secondary|Total Dose of Propofol Administered - Bolus|Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.||mg/kg||Standard Deviation|Mean
143978|NCT00436345|Secondary|Dose of Morphine Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Morphine were analyzed.||mg/kg/h||Standard Deviation|Mean
143979|NCT00436345|Secondary|Dose of Propofol Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Propofol were analyzed.||mg/kg/h (milligrams per kilogram per hr)||Standard Deviation|Mean
143980|NCT00436345|Secondary|Doses of Sufentanil and Fentanil Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.||ug/kg/h||Standard Deviation|Mean
143981|NCT00436345|Secondary|Dose of Remifentanil Administered – Continuous Infusion|Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|Up to 10 days|ITT Population. Only participants dosed with Remifentanil were analyzed.||ug/kg/h (micrograms per kilogram per hr)||Standard Deviation|Mean
143982|NCT00436345|Secondary|Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)|Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.|up to 10 days (240 hours)|ITT Population. Only participants infused with Sufentanil, Fentanil, and Morphine were analyzed.||hours||Standard Deviation|Mean
151818|NCT00371397|Primary|Immune Function: Interleukin-6 (IL-6)|Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions|Day 1 8:30, 11:35, 13:10. Day 2 7:30||||||
143987|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Per-Protocol Population)|Time from start of mechanical ventilation until actual extubation|Up to 38 days (912 hours)|Per-Protocol (PP) Population: all participants from the MITT population without any major protocol violation||Hours||Standard Error|Mean
143988|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation.|Up to 38 days (912 hours)|Modified-Intent-to-Treat (mITT) Population: all randomised participants who had taken at least one dose of study medication and who had efficacy measurements||Hours||Standard Error|Mean
143989|NCT00436345|Secondary|Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator’s Decision)|Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.|Up to 38 days (912 hours)|ITT Population. Only participants with available ICU data were analyzed.||Hours||Standard Deviation|Mean
143990|NCT00436345|Primary|Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)|Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).|Up to 38 days (912 hours)|Intent-to-Treat (ITT) Population: all randomised participants who had taken at least one dose of study medication||Hours (hr)||Standard Error|Mean
143991|NCT00436332|Secondary|Toxicity||From date of registration to maximum of 3 years||||||
143992|NCT00436332|Secondary|Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease|Images for response assessed by the central computer-assisted image-analysis system were never collected.|From date of registration to maximum of 3 years|||Participants|||Count of Participants
143993|NCT00436332|Secondary|Progression-free Survival||From date of registration to maximum of 3 years|||months||95% Confidence Interval|Median
143994|NCT00436332|Primary|Overall Survival||From date of registration to maximum of 3 years|||months||95% Confidence Interval|Median
143995|NCT00436215|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 28 months|||participants|||Number
143996|NCT00436215|Secondary|Progression-free Survival|Progression free survival is defined by the number of weeks between the first day of treatment and the date of cancer progression.|up to 28 months|||Weeks||Standard Deviation|Mean
143997|NCT00436215|Primary|Clinical Response Rate.|Clinical response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started lasting at least 6 months.|patients were followed for a median of 18 weeks (range 1-116 weeks)|Seven patients were not evaluable for response assessment.||percentage of participants|||Number
143998|NCT00436163|Secondary|Percentage of Anti-HBe Positive Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.||percentage of participants|||Number
143999|NCT00436163|Secondary|Percentage of HBeAg Negative Participants|HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.||percentage of participants|||Number
144000|NCT00436163|Secondary|Mean Alanine Aminotransferase (ALT) Concentrations||Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.||international units per liter (IU/L)||Standard Deviation|Mean
144001|NCT00436163|Secondary|Percentage of Anti-HBs Positive Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome and n= participants with available data at specified time points.||percentage of participants|||Number
144002|NCT00436163|Secondary|Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants|HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.|Week 48 and Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.||percentage of participants|||Number
144003|NCT00436163|Secondary|Number of Participants With HBV-DNA < 400 Copies/mL||Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants evaluable for this outcome measure.||participants|||Number
144004|NCT00436163|Primary|Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline.||participants|||Number
151879|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|6 month follow-up|||units on a scale||Standard Deviation|Mean
144005|NCT00436163|Primary|Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)|HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.|Week 72|All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline.||participants|||Number
144006|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization|||Participants|||Number
144007|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 28 days after immunization, relative to pre-immunization levels.|28 days after immunization|||Participants|||Number
144008|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 28 Days After Intranasal Immunization|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 28 after immunization, relative to pre-immunization levels.|28 days after immunization.|||Participants|||Number
144009|NCT00436046|Other Pre-specified|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza B at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization|||Participants|||Number
144010|NCT00436046|Secondary|Unsolicited Adverse Events After Intranasal Immunization|Number of subjects (frequency) with spontaneous reports of Adverse Events of any severity and severe or higher severity, during the 28 days after vaccination regardless of relatedness. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Non-serious AEs are collected through 28 days after vaccination. Serious AEs are collected through 180 days after vaccination.|A reporting threshold of 5.6% was selected after reviewing adverse event rates in healthy adult volunteers in similar studies sponsored by NIAID. We determined 5.6% to be the upper bound of the confidence interval to exclude reporting events that occur in 75% of healthy adults.||Participants|||Number
144011|NCT00436046|Secondary|Serum Antibody Responses (Hemagglutination Inhibition (HAI) and Neutralization) to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at 14 days after immunization, relative to pre-immunization levels.|14 days after immunization.|||Participants|||Number
144012|NCT00436046|Secondary|Local and/or Systemic Solicited Symptoms After Intranasal Immunization.|Number of participants (frequency) reporting solicited (systematically collected on a Memory Aid) reactogenicity events of any severity and number reporting severe occurrences.|0-7 days following immunization|||Participants|||Number
144013|NCT00436046|Primary|Antibody Responses in Nasal Secretions to Influenza A/H1N1 and A/H3N2 at 14 Days After Intranasal Immunization.|Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels|14 days after immunization.|||Participants|||Number
144014|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
144015|NCT00436007|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 30-day (Days 0-29) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
144016|NCT00436007|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever [axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.|During the 7-day (Days 0-6) follow-up period after any vaccination|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.||subjects|||Number
144017|NCT00436007|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately.|During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.|The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.||subjects|||Number
144018|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
144019|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
144020|NCT00436007|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
144021|NCT00436007|Secondary|Titers for Anti-yellow Fever Antibodies.|"Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.~The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups."|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||titers||95% Confidence Interval|Geometric Mean
144022|NCT00436007|Secondary|Concentrations of Anti-measles Antibodies.|Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.|At Months 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
144023|NCT00436007|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.|Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
144024|NCT00436007|Secondary|Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).|Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||titers||95% Confidence Interval|Geometric Mean
144025|NCT00436007|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.|Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||µg/mL||95% Confidence Interval|Geometric Mean
144026|NCT00436007|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 8 to Month 19|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
144027|NCT00436007|Secondary|Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.|At Month 3|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||IU/mL||95% Confidence Interval|Geometric Mean
144028|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
144085|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|Baseline|||units on a scale||Standard Deviation|Mean
144029|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 2 Group.|At Months 0, 3, 7 and 8.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
144030|NCT00436007|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).|Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.|At Months 0, 1, 3 and 7.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.||mIU/mL||95% Confidence Interval|Geometric Mean
144031|NCT00436007|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
144032|NCT00435994|Primary|Endothelial Growth Factor (VEGF)|Analysis for VEGF level by ELISA|During nasal wash|Due to limited samples and the length of time that has passed since they were obtained, we are unable to separate Bronchiolitis from RSV.||pg/dl||Standard Deviation|Mean
144033|NCT00435994|Primary|Lung Function|Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.|Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)|All participants who had baseline, post bronchodilator and post epinephrine measurements were included. Participants in the Bronchiolitis arm did not have infant pulmonary functions obtained.||Z score||Standard Deviation|Mean
144034|NCT00435929|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings included are high and low Heart Rate (HRT), high and low PQ/PR interval (PQ/PR), high and low QRS interval (QRS), high and low QT interval (QT), high and low QTCB interval (QTcB), high and low QTcF interval (QTcF), high and low RR interval (RR), high and low T Wave, high and low U Wave, high and low ECG. The 12 Lead ECG was recorded after participants were in a semi-supine position for at least 5 minutes. Only participants with abnormal ECG findings are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.||participants|||Number
144035|NCT00435929|Secondary|Number Participants With Abnormal Vital Signs|Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.||participants|||Number
144036|NCT00435929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters|Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below.|Up to Day 35|Safety population: All participants who received at least 1 dose of study medication (whether or not they were withdrawn prematurely) and had safety follow-up data were included in safety analysis.||participants|||Number
144037|NCT00435929|Secondary|Cluster of Differentiation 4 (CD4 ) Count|The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group.|Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35)|PD analysis population: All participants who received at least 1 dose of the study medication and had at least 1 pharmacodynamic (PD) measure were included in the PD analysis population.||cells/cubic millimeter||Standard Deviation|Mean
144038|NCT00435929|Secondary|Volume of Distribution (Vd) of SQV and RTV|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||Litres||Standard Deviation|Mean
144039|NCT00435929|Secondary|Plasma Clearance After Oral Administration (CL/F) of SQV and RTV|The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||L/hr||Standard Deviation|Mean
144086|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|12 month|||participants|||Number
144087|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|3 month|||participants|||Number
144040|NCT00435929|Secondary|Minimum Observed Plasma Concentration (Cmin) of SQV and RTV|Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||ng/mL||Standard Deviation|Mean
144041|NCT00435929|Secondary|Terminal Half-life (T1/2) of SQV and RTV|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||hour||Standard Deviation|Mean
144042|NCT00435929|Secondary|Time of Maximum Plasma Concentration (Tmax) of SQV and RTV|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||hour||Standard Deviation|Mean
144043|NCT00435929|Primary|Maximum Observed Plasma Concentration (Cmax) of SQV and RTV|The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||ng/mL||Standard Deviation|Mean
144044|NCT00435929|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.|Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14|Pharmacokinetic (PK) analysis population: All participants who adhered to the study protocol and had evaluable concentration data and PK parameters on Day 14.||ng*hr/mL||Standard Deviation|Mean
144045|NCT00435825|Secondary|Quantitative HBV-DNA 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.||IU/mL Log10||95% Confidence Interval|Mean
144046|NCT00435825|Secondary|Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.||U/L||95% Confidence Interval|Mean
144047|NCT00435825|Secondary|Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment|Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA <2,000 IU/ml (Less than 10,000 copies/mL).|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144048|NCT00435825|Secondary|Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment|Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144049|NCT00435825|Secondary|Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of < 2,000 IU/mL (Less than 10,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144050|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment|Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of < 20,000 IU/mL (Less than 100,000 copies/mL) is reported.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144051|NCT00435825|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT)|Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144052|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment|Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144053|NCT00435825|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144054|NCT00435825|Secondary|Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment|Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144055|NCT00435825|Secondary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.|Week 72|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144056|NCT00435825|Primary|Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment|Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.|24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)|Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.||Percentage of participants||95% Confidence Interval|Number
144057|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 6 mEq/L increase from baseline or confirmed normal serum sodium level exceeding 135 mEq/L.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."||Participants|||Number
144058|NCT00435591|Secondary|Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours|"Patients with confirmed serum sodium level exceeding 4 mEq/L increase from baseline.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|0-24.5 hours, 0-48.5 hours and 0-96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."||Participants|||Number
144088|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|Baseline|||participants|||Number
144089|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|12 month|||times per week||Standard Deviation|Mean
144090|NCT00435188|Primary|Rapid Gait Speed||12-month|||meters/second||Standard Deviation|Mean
144059|NCT00435591|Secondary|Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period|"The upper limits of the interquartile range were not estimable in three of the treatment arms. Only the “placebo loading dose + YM087 premix continuous infusion” arm will be reported.~Time is number of hours to reach an increase of exceeding 4 mEq/L from baseline serum sodium.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|48.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."||Hours||Inter-Quartile Range|Median
144060|NCT00435591|Secondary|Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours|"AUCna t is calculated as the baseline-adjusted area under serum sodium levels for a duration of time 0 to time t.~Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period."|24.5 hours, 48.5 hours and 96.5 hours|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants per arm is consistent for all categories of the data table."||hr * mEq/L||Standard Deviation|Mean
144061|NCT00435591|Secondary|Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period|"Baseline serum sodium value is the average of 2 serum sodium values taken at least 4 hours apart on Day-1 and within 24 hours of Hour 0 in the Treatment Period.~Change from Baseline is calculated as Time point minus Baseline."|Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment|"Population is Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study drug and who had both baseline and postbaseline serum sodium data.~The number of participants analyzed per arm represents Full Analysis Set. The numbers of participants for each time point are noted in the category titles."||mmol/L||Standard Deviation|Mean
144062|NCT00435591|Primary|Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2|"Infusion Site Reaction (ISR) was any local event other than isolated pain, bleeding, or bruising at the site of infusion.~One ISRMS has been reported for each participant & represents the most severe state of ISR for that participant.~ISR scale is a health care provider assessment of ISRs using the following modified 5 point reporting scale: 0= No new reaction; 1+=Infusion site erythema, infusion site pain, infusion site warmth; 2+= Infusion site edema; 3+=Phlebitis, venous induration; 4+=Thrombophlebitis, venous thrombosis, infusion site infection, infusion site cellulitis"|48 hours|"Population is Safety Analysis Set (SAF): All randomized patients who received at least 1 dose of study drug.~The number of participants per arm is consistent for all categories of the data table."||Participants|||Number
144063|NCT00435539|Primary|Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.||Day 14|Intention to Treat (ITT)||percentage of participants|||Number
144064|NCT00435539|Secondary|Resolution of Vitreomacular Traction (Investigator's Assessment)|Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.|Day 28|Intention to Treat (ITT)||Percentage of participants|||Number
144065|NCT00435487|Secondary|Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria|Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%.|End of hospitalization, Day 30|Evaluable population||participants|||Number
144066|NCT00435487|Secondary|Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization|Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically.|End of hospitalization, Day 30|Evaluable population||participants|||Number
144067|NCT00435487|Secondary|Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase – myocardial band (CPK-MB) levels and the qualitative troponin-T test.|End of hospitalization, Day 30|Evaluable population||participants|||Number
144068|NCT00435487|Secondary|Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization|Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization.|End of hospitalization, Day 30|Evaluable population||participants|||Number
144069|NCT00435487|Secondary|Number of Subjects With Stroke|Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma).|End of hospitalization, Day 30|Evaluable population||participants|||Number
144070|NCT00435487|Primary|Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30|Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase – myocardial band (CPK-MB) levels and the qualitative troponin-T test.|Baseline to Day 30|Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint.||participants|||Number
144071|NCT00435409|Secondary|Change From Baseline in EuroQol Group’s EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.||Score on a scale||95% Confidence Interval|Mean
144072|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of each treatment cycle (up to 3 years or end of treatment)|PRO assessments were not analyzed because the study did not meet its primary endpoint.||Score on a scale||Standard Deviation|Mean
144073|NCT00435409|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer’s Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms|Day 1 of each treatment cycle (up to 3 years or end of treatment)|Patient Reported Outcomes (PRO) assessments were not analyzed because the study did not meet its primary endpoint.||score on a scale||Standard Deviation|Mean
144074|NCT00435409|Secondary|Percent Chance of Participant Survival|Probability of survival 2 years and 3 years after the first dose of study treatment.|Year 1, Year 2, Year 3|ITT population||probability of survival||95% Confidence Interval|Number
144075|NCT00435409|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.|Baseline until death or up to 3 years from first dose|ITT population||months||95% Confidence Interval|Median
144076|NCT00435409|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.|Baseline until response or disease progression (up to 3 years from first dose)|ITT subgroup of participants with a confirmed objective tumor response.||months||95% Confidence Interval|Median
144077|NCT00435409|Secondary|Percentage of Participants With Objective Response (OR)|Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population||percentage of participants||95% Confidence Interval|Number
144078|NCT00435409|Primary|Progression Free Survival (PFS)|Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.|Baseline until disease progression (up to 3 years from first dose)|Intent to treat (ITT) population: defined as all participants who were randomized||months||95% Confidence Interval|Median
144079|NCT00435370|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains|"The following 8 scales are combined into a single index that is normalized with a mean score of 100 and a standard deviation of 10. Higher scores are considered better cognitive performance. No subscales scores are reported and a final standardized score is reported as the average of the standardized scores on each of these scales. Here is the listing of component scales that were translated into Chinese and used for this study:~Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding Trail Making Test: Part A Attention/Vigilance Continuous Performance Test—Identical Pairs (CPT-IP)* Wechsler Memory Scale®—3rd Ed. (WMS®-III): Spatial Span + Letter-Number Span Hopkins Verbal Learning Test—Revised™ (HVLT-R™) Brief Visuospatial Memory Test—Revised (BVMT-R™) Neuropsychological Assessment Battery® (NAB®): Mazes~Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™):"|end of 12 wk treatment|||units on a scale||Standard Deviation|Mean
144080|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|12 month|||meters||Standard Deviation|Mean
144081|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|3 month|||meters||Standard Deviation|Mean
144082|NCT00435188|Secondary|2 Minute Walk|Distance walked in two minutes in meters|Baseline|||meters||Standard Deviation|Mean
144083|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|12 month|||units on a scale||Standard Deviation|Mean
144084|NCT00435188|Secondary|Sf-36 Physical Function Subscale|This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.|3 month|||units on a scale||Standard Deviation|Mean
144095|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|3 month|||times per week||Standard Deviation|Mean
144096|NCT00435188|Secondary|Physical Activity Frequency (CHAMPS Questionnaire)|Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities|Baseline|||times per week||Standard Deviation|Mean
144097|NCT00435188|Primary|Usual Gait Speed|Best of two trials over 8-foot walk|Baseline|||meters/second||Standard Deviation|Mean
144098|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
144099|NCT00435162|Secondary|Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)||week 6 and week 8|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
144100|NCT00435162|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
144101|NCT00435162|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)||baseline and week 6|Analysis: Intention to Treat Imputation Technique: Last Observation Carried Forward (LOCF)||mm Hg||Standard Deviation|Mean
144102|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 16 During 40 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 16|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144103|NCT00435045|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol From Baseline to Week 12 During 20 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 12|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144104|NCT00435045|Secondary|Percent Change in Total Adiponectin From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Adiponectin is a protein hormone that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144105|NCT00435045|Secondary|Percent Change in Remnant-like Particle Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Remnant-like particle cholesterol within the plasma has been identified as a cardiovascular risk factor.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144106|NCT00435045|Secondary|Percent Change in Intermediate Density Lipoprotein Particle Concentration From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Intermediate Density Lipoprotein, or IDLs, transport cholesterol and triglycerides through the body. IDLs are a type of cholesterol that are a product of VLDL degradation and result in LDL cholesterol when broken down.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144107|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144108|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins and Chylomicron Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Very low density lipoproteins are plasma lipoproteins with a high lipid content, associated with atherosclerosis. Chylomicrons are One of the microscopic particles of emulsified fat found in the blood and lymph and formed during the digestion of fats.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144120|NCT00435045|Secondary|Percent Change in Apolipoprotein-A-1 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein A1 - major protein component of high density lipoprotein (HDL) in plasma. The protein promotes cholesterol efflux from tissues to the liver for excretion.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144109|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144110|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL) Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|High Density Lipoprotein partical size suggests the bigger the better. HDL is a complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144111|NCT00435045|Secondary|Percent Change in Lipoprotein-Phosphoslipase A2 From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Lipoprotein Phosphoslipase A2 - modified form of LDL.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144112|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Size From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease. Researchers have linked LDL particle size to the subsequent development of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144113|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein Particle Concentration Total From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Low-density lipoproteins - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144114|NCT00435045|Secondary|Percent Change in Eicosapentaenoic Acid (EPA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Eicosapentaenoic acid (EPA) is one of several omega-3 fatty acids used by the body. It is found in cold water fatty fish and in fish oil supplements, along with docosahexaenoic acid (DHA). Omega-3 fatty acids are part of a healthy diet that helps lower risk of heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144115|NCT00435045|Secondary|Percent Change in Docosahexaenoic Acid (DHA) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Docosahexaenoic Acid is an omega-3 essential fatty acid.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144116|NCT00435045|Secondary|Percent Change in Triglycerides/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period||Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144117|NCT00435045|Secondary|Percent Change in Total Cholesterol/High Density Lipoprotein Cholesterol Ratio From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total cholesterol/High density lipoprotein cholesterol|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144118|NCT00435045|Secondary|Percent Change in Apolipoprotein C-III From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Apolipoprotein C-III (APOC3) is a very low density lipoprotein (VLDL) protein. APOC3 inhibits lipoprotein lipase and hepatic lipase; it is thought to delay catabolism of triglyceride-rich particles.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144119|NCT00435045|Post-Hoc|Percent Change in Apolipoprotein-B From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"Apolipoprotein B is the primary apolipoprotein of low density lipoproteins (LDL or bad cholesterol), which is responsible for carrying cholesterol to tissues."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144121|NCT00435045|Secondary|Percent Change in Very Low Density Lipoproteins (VLDL) Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|VLDL - very-low-density lipoprotein: a plasma lipoprotein with a high lipid content, associated with atherosclerosis.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144122|NCT00435045|Secondary|Percent Change in Triglycerides From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Triglycerides - A naturally occurring ester of three fatty acids and glycerol that is the chief constituent of fats and oils.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144123|NCT00435045|Secondary|Percent Change in Low Density Lipoprotein (LDL) Cholesterol (Beta-quantification) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|LDL - A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. High levels are associated with an increased risk of atherosclerosis and coronary heart disease.|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Please note: processing errors, inadequate sample volume, sample and shipment storage issues etc., resulted in some MITT subjects without data.||percent change||Inter-Quartile Range|Median
144124|NCT00435045|Secondary|Percent Change in High Density Lipoprotein (HDL)Cholesterol From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|"HDL - A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. High levels are associated with a decreased risk of atherosclerosis and coronary heart disease.~High density lipoprotein cholesterol is the Total Cholesterol minus the sum of the LDL, VLDL and IDL."|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144125|NCT00435045|Secondary|Percent Change in Total Cholesterol (TC) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Total Cholesterol is the sum of the High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), Very Low Density Lipoproteins (VLDL), and Intermediate Density Lipoproteins (IDL).|Baseline and Week 8|Modified Intent To Treat Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144126|NCT00435045|Primary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period|Non-high density lipoprotein cholesterol is the Total Cholesterol minus the HDL(high density lipoproteins or the sum of the LDL, VLDL and IDL. That is, Low Density Lipoproteins, Very Low Density Lipoproteins and Intermediate Density Lipoproteins.|Baseline and Week 8|Modified Intent To Treat (MITT) Population - all randomized subjects who took at least 1 dose of study medication and provided at least 1 post-randomization efficacy data point. Only subjects with non-missing baseline and endpoint values are included.||percent change||Inter-Quartile Range|Median
144127|NCT00435019|Secondary|Observed Insulin Antibody Values|Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.|at 0 and 52 weeks|Safety analysis set (SAS): All randomised subjects exposed to at least one dose of trial product, classified according to actual treatment. In some cases, antibody samples were taken earlier than required. These results were not included. A shipment of antibody samples was lost during transportation, and thus these antibody data were missing.||Percent bound of total||Standard Deviation|Mean
144128|NCT00435019|Secondary|Number of Subjects Reporting Adverse Events|"Number of subjects reporting adverse events during the trial (from week -2 to week 52).~For details, please refer to the adverse events section."|from week -2 to week 52|Safety analysis set (SAS): all randomised subjects exposed to at least one dose of trial product, classified according to actual treatment.||participants|||Number
144129|NCT00435019|Primary|Glycosylated Haemoglobin A1c (HbA1c)|Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.|after 52 weeks of treatment|Full Analysis Set (FAS) is defined as all randomised subjects exposed to at least one dose of trial product with a postbaseline observation, classified according to randomised treatment.||Percent (%) glycosylated haemoglobin||Standard Error|Mean
144130|NCT00434993|Secondary|Plasma Levels of IL-6 and IL-8 on Study Day 3|Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon’s test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes.|Measured at baseline and 3 days after randomization|Not all subjects had available data for secondary analyses and therefor the numbers will be less than the 152 (active) and 130 (placebo) arms.||pg/ml||Standard Deviation|Log Mean
144131|NCT00434993|Secondary|Hospital Mortality up to Day 60 in Subjects With Baseline Shock|Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 60 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.||percentage of participants who died|||Number
144132|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure<60 or the need for vasopressors (except dopamine <6 ug/kg/min).|Determined 28 days after a subject entered the study|Patients with protocol defined shock (mean arterial pressure<60 or need for vasopressors except dopamine < 6ug/kg/min) at the time of study entry.||days||Standard Error|Mean
144133|NCT00434993|Secondary|Hospital Mortality to Day 60 in the Subset of Participants With ARDS|Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.|Determined 60 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.||percentage of participants who died|||Number
144134|NCT00434993|Secondary|Ventilator Free Days to Day 28 in the Subset of Participants With ARDS|Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.|Determined 28 days after a subject entered the study|Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.||days||Standard Error|Mean
144135|NCT00434993|Secondary|Number of Organ Failure-free Days at Day 28 Following Randomization|Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.|Daily from baseline to study day 28|Intent to treat.||days||Standard Error|Mean
144136|NCT00434993|Secondary|Number of ICU-free Days at 28 Days After Randomization|ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.|Determined 28 days after a subject entered the study|Intent to treat.||days||Standard Error|Mean
144137|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90|Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived.|Determined 90 days after a subject entered the study|Intent to treat.||percentage of participants who died|||Number
144138|NCT00434993|Secondary|Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60|Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived.|Determined 60 days after a subject entered the study|Intent to treat population.||percentage of participants who died|||Number
144139|NCT00434993|Primary|Number of Ventilator Free Days (VFD)|Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.|Determined 28 days after a subject entered the study|All the intent to treat patients were analyzed. Data was available on all subjects for the primary analysis only.||days||Standard Error|Mean
144140|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks||||||
144141|NCT00434967|Secondary|To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study).||Baseline to 8 weeks||||||
144142|NCT00434967|Secondary|To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP.||Baseline to 8 weeks||||||
144143|NCT00434967|Secondary|To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings.||Baseline to 8 weeks||||||
144144|NCT00434967|Secondary|Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP).||Baseline to 8 weeks||||||
144145|NCT00434967|Secondary|The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study|Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study|8 weeks|||participants|||Number
144146|NCT00434967|Primary|Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)|Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.|8 weeks|||mm Hg||Standard Error|Least Squares Mean
144147|NCT00434967|Primary|Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).|Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.|8 weeks|||mm Hg||Standard Error|Least Squares Mean
144148|NCT00434954|Secondary|Patient Reported Outcomes: Quality of Life (SF-12)|SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||scores on SF-12 scale||Standard Deviation|Mean
144149|NCT00434954|Secondary|Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)|Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||scores on DTSQ scale||Standard Deviation|Mean
144150|NCT00434954|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward||kg/m^2||Standard Error|Least Squares Mean
144151|NCT00434954|Secondary|Change in Body Weight|Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward||kg||Standard Error|Least Squares Mean
144152|NCT00434954|Primary|Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)|Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)||Percentage of participants|||Number
144153|NCT00434954|Secondary|Blood Lipid Levels|Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||mmol/L||Standard Deviation|Mean
144154|NCT00434954|Secondary|7 Point Self-monitored Blood Glucose (SMBG) Profiles|7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||mg/dL||Standard Deviation|Mean
144155|NCT00434954|Secondary|Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)|Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)||Percentage of participants|||Number
144156|NCT00434954|Secondary|Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)|Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%]|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)||Percentage of participants|||Number
144157|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 7.0%|Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||Percentage of participants|||Number
144158|NCT00434954|Secondary|Percentage of Subjects Achieving HbA1c Target of < 6.5%|Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%].|26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward||Percentage of participants|||Number
144159|NCT00434954|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)|Baseline and 26 weeks|All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
144160|NCT00434876|Secondary|Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.|The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes).|Baseline, and week 8|||minutes||Standard Deviation|Mean
144161|NCT00434876|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"PSQI total score (range 0-21). A PSQI total score > 5 indicates insomnia, with higher scores denoting a decrease in sleep quality.~The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9."|Baseline, weeks 4, and 9.|||units on a scale||Standard Deviation|Mean
144164|NCT00434759|Primary|Change From Baseline in Liebowitz Social Anxiety Scale (LSAS)|The scale measures social anxiety and avoidance on a 4-point-scale (range of scores is 0-3). Blinded raters assessed social anxiety and avoidance behaviour relating to 24 social situations. Minimum for all 24 situations is 0, maximum for all 24 situations including the assessments for anxiety and avoidance is 144). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
144165|NCT00434759|Primary|Change From Baseline in Social Phobia Scale (SPS)|The scale measures social anxiety on a 5-point scale (range of score is 0-4) ; the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
144166|NCT00434759|Secondary|Change on Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)|The scale measures depressive symptoms on 20 items on a 4-point scale (range of scores is 0-3; minimum for all 20 items is 0, maximum 60). Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
144167|NCT00434759|Secondary|Change From Baseline in Brief Symptom Inventory (BSI)|The scale measures general psychopathology on 53 items on a 5-point scale (range of scores is 0-4). Minimum for all 53 items is 0, maximum is 212. Lower scores consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
144168|NCT00434759|Primary|Change From Baseline in Social Interaction Anxiety Scale (SIAS)|This scale measures interaction anxiety on a 5-point scale (range of scores is 0-4); the number of items is 20; the total minimum for all 20 items is 0 and the total maximum is 80; lower values consider better outcome.|baseline to post-treatment (on average 24 weeks)|Intention-to-Treat||units on a scale||Standard Deviation|Mean
144169|NCT00434642|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event||From randomization through July 19, 2013 (up to 6 years, 3 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.||Percentage of participants|||Number
144170|NCT00434642|Secondary|Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)|A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Safety population: All patients who received at least 1 dose of protocol treatment. Due to errors in drug administration, the safety population included 247 patients in the carboplatin and gemcitabine + bevacizumab group and 233 patients in the carboplatin and gemcitabine + placebo group.||Percentage of participants|||Number
144171|NCT00434642|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|From randomization through July 19, 2013 (up to 6 years, 3 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).||Months||95% Confidence Interval|Median
144172|NCT00434642|Secondary|Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|Duration of OR was analyzed in the subset of patients who achieved an OR. The duration of OR was defined as the time from the initial CR or PR until documented PD or death. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Subset of the intent-to-treat population: All patients randomized to treatment who achieved an objective response.||Months||95% Confidence Interval|Median
144173|NCT00434642|Secondary|Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|An objective response was the occurrence of either a partial response (PR) or complete response (CR). PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR: The disappearance of all target and non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).||Percentage of participants|||Number
144174|NCT00434642|Primary|Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)|PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause. PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions. Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.|From randomization through September 17, 2010 (up to 3 years, 5 months)|Intent-to-treat population: All patients randomized to treatment (242 patients in each treatment group).||Months||95% Confidence Interval|Median
144175|NCT00434590|Secondary|Chronic Rejection as Confirmed by Renal Biopsy at 12 Months||12 months||||||
144176|NCT00434590|Secondary|Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months||12 months||||||
144177|NCT00434590|Secondary|Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months||12 months||||||
144178|NCT00434590|Secondary|Serum Creatinine at 12 Months||12 months||||||
144179|NCT00434590|Secondary|Creatinine Clearance at 12 Months||12 months||||||
144180|NCT00434590|Primary|Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months|The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.|12 months|Study was terminated without analysis (small sample size).||mL/min||Standard Deviation|Mean
144181|NCT00434434|Secondary|Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.|From baseline to Week 16|Modified ITT population||ratio of FEV1||Full Range|Median
144182|NCT00434434|Primary|Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)|The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.|From baseline to Week 16|Modified intent-to-treat (ITT) population||concentration change||Full Range|Median
144183|NCT00434421|Primary|Proportion of Participants Who Discontinue Study|Proportion of participants who discontinued study for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment)|Initial placebo dose to end of 2-week treatment course (maximum study dose)|Safety Population: All study participants who were initiated onto the initial placebo study||Percentage of Participants|||Number
144184|NCT00434356|Secondary|Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients||participants|||Number
144185|NCT00434356|Secondary|Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients||participants|||Number
144186|NCT00434356|Secondary|Adverse Events Leading to Death|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|30 days following the last administration of study treatment|Treated patients||participants|||Number
144187|NCT00434356|Secondary|Grade ≥ 3 Adverse Events (AEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Grading: 1=Mild AE; 2=Moderate AE; 3=Severe AE; 4=Life-threatening or disabling AE; 5=Death related to AE|30 days following the last administration of study treatment|Treated patients||participants|||Number
144188|NCT00434356|Secondary|Serious Adverse Events (SAEs)|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|30 days following the last administration of study treatment|Treated patients||participants|||Number
144189|NCT00434356|Primary|Best Response|The best overall response is the best response, per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence (by patient)|Randomized patients with at least one scan available at baseline and post-baseline||participants|||Number
144190|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 9.5 g/dL to 13.0 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population||percentage of participants|||Number
144191|NCT00434330|Other Pre-specified|Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 10 g/dL to 12.5 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population||percentage of participants|||Number
144192|NCT00434330|Other Pre-specified|Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29)|Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within 1 g/dL below to 1.5 g/dL above baseline) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.|Weeks 2 to 29|mITT population||percentage of participants|||Number
144193|NCT00434330|Primary|Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.|The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.|Baseline and Weeks 2-29|Modified intent-to-treat (mITT) population||g/dL||Standard Deviation|Mean
144194|NCT00434304|Secondary|Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||beats per minute (bpm)||Standard Deviation|Mean
144195|NCT00434304|Secondary|Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52|Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||millimeters of mercury (mmHg)||Standard Deviation|Mean
144196|NCT00434304|Secondary|Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52|Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.|Baseline (Screening) and Weeks 16 and 52|Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||participants|||Number
144197|NCT00434304|Secondary|Urinalysis Data|The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.|Screening, Week 16, and Week 52|Safety Population: Screening Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants||participants|||Number
144198|NCT00434304|Secondary|Change From Baseline in Red Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||tera per Liter (TI/L)||Standard Deviation|Mean
144199|NCT00434304|Secondary|Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||giga per Liter (GI/L)||Standard Deviation|Mean
144200|NCT00434304|Secondary|Change From Baseline in Hematocrit at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||proportion of 1 (SI)||Standard Deviation|Mean
144201|NCT00434304|Secondary|Change From Baseline in Prolactin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||micrograms per Liter (MCG/L)||Standard Deviation|Mean
144202|NCT00434304|Secondary|Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||millimoles per Liter (MMOL/L)||Standard Deviation|Mean
144203|NCT00434304|Secondary|Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||micromoles per Liter (UMOL/L)||Standard Deviation|Mean
144204|NCT00434304|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||international units per Liter (IU/L)||Standard Deviation|Mean
144205|NCT00434304|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52|Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.|Baseline (Screening) and Weeks 16 and 52|Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward [LOCF]) = 62 participants; Week 52 (Observed case [OC]) = 44 participants||grams per Liter (G/L)||Standard Deviation|Mean
144206|NCT00434304|Secondary|Percentage of Participants Who Remained in the Study on the Indicated Days|The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.|Days 0-364|FAS. Participants dropped out of the study each week.||percentage of participants|||Number
144207|NCT00434304|Secondary|Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale|"CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as very much improved or much improved."|Weeks 1-52|FAS. Participants dropped out of the study each week.||participants|||Number
144208|NCT00434304|Secondary|Summary of the Modified Hoehn & Yahr Criteria Stages|Hoehn & Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).|Screening-Week 52|FAS. Participants dropped out of the study each week.||points on a scale|||Number
144209|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
144210|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144211|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part IV|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Baseline (Week 0) and Weeks 0-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144212|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
144213|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144214|NCT00434304|Primary|Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites|Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.|Weeks 1-16|PK Population. Blood sampling was performed in all participants in the Fixed titration phase and Maintenance dose phase to measure trough concentration. The maintenance dose differs for individual participants.||pg/mL||Standard Deviation|Mean
144215|NCT00434304|Primary|Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.|Weeks 5-16|PK Population||hours||90% Confidence Interval|Median
144216|NCT00434304|Primary|Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.|Weeks 5-16|PK Population||hours*pg/mL||95% Confidence Interval|Geometric Mean
144217|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part II|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144218|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
144219|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part I|The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144220|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part I|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144221|NCT00434304|Secondary|Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III|A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percentage of responders|||Number
144222|NCT00434304|Secondary|Percent Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||percent change||Standard Deviation|Mean
144223|NCT00434304|Secondary|Change From Baseline in the Japanese UPDRS Part III|The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Baseline (Week 0) and Weeks 1-52|FAS. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144224|NCT00434304|Secondary|Total Score in the Japanese UPDRS Part III|The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0-52|Full Analysis Set (FAS): all participants who progressed to the treatment phase, excluding those who did not fulfill major registration criteria, those who had not received at least one dose of the investigational drug, and those whose measured data were not available after treatment initiation. Participants dropped out of the study each week.||points on a scale||Standard Deviation|Mean
144237|NCT00434226|Secondary|Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
144225|NCT00434304|Primary|Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites|The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.|Weeks 5-16|Pharmacokinetic (PK) Population: participants who underwent blood sampling for PK research, excluding those who did not fulfill inclusion criteria and those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.||picograms/milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
144226|NCT00434278|Secondary|Change in Pulmonary Function as Measured by FEV1 and FVC|FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) were recorded at Day 0 (baseline) and Day 14. Change in FEV1 and FVC from baseline to Day 14 was reported as a percentage of values predicted for age, height, and race.|From baseline to Day 14|Randomized patients. Patients not included in this analysis did not meet ATS reproducibility criteria. Two patients in the placebo arm whose screening visit values did not meet ATS reproducibility criteria were randomized in error and completed the study.||Percentage of predicted value||Standard Deviation|Mean
144227|NCT00434278|Primary|Change in Distance Walked in the 6-minute Walk Test|Change in distance walked was defined as (distance walked in 6 minutes at baseline [Day 0]) − (distance walked in 6 minutes at Day 14) in meters.|From baseline to Day 14|Randomized patients. For placebo arm: 2 placebo patients who were randomized did not complete the study and therefore had no values to calculate change from baseline computation.||Meters||Standard Deviation|Mean
144228|NCT00434252|Secondary|Number of Participants With Select Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. Select adverse events included arterial thromboembolic events (any grade), bleeding other than pulmonary or central nervous system (CNS) bleeding (Grade >= 3), CNS bleeding (any grade), febrile neutropenia (any grade), hypertension (Grade >= 3), neutropenia (Grade >= 3), pulmonary bleeding (any grade) and wound dehiscence (Grade >= 3).~*All serious adverse events are listed in the Adverse Event Reporting section."|Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.|The Safety-evaluable population consisted of all patients who received at least one full or partial dose of any component of study treatment.||participants|||Number
144229|NCT00434252|Secondary|Twenty−Four Week Landmark Stable Disease|"As assessed by the investigator using RECIST and defined as the absence of disease progression for 24 weeks from the time of randomization.~The percentage of patients who did not experience disease progression or death at 24 weeks following randomization was estimated using Kaplan-Meier methodology. If no tumor assessments were performed after the baseline visit, the patient will be censored at the date of randomization plus 1 day."|24 weeks|Intent-to-treat (randomized) patients||percentage of participants||95% Confidence Interval|Number
144230|NCT00434252|Secondary|Six-month Landmark Survival Rate|Six-month Landmark Survival Rate was defined as the percentage of participants surviving at 6 months following randomization. Overall Survival was estimated using the Kaplan−Meier method.|6 months|Intent-to-treat (randomized) population||percentage of participants||95% Confidence Interval|Number
144231|NCT00434252|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial objective response to documented disease progression or death, whichever occurred first, assessed by the investigator using RECIST. Progressive disease was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Duration of response was estimated using the Kaplan-Meier method.|Up to 102 weeks|Intent-to-treat (randomized) population. Only patients with measurable disease who achieved a response (either partial or complete) were included in the analysis of duration of response||months||95% Confidence Interval|Median
144232|NCT00434252|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response according to RECIST criteria as assessed by the investigator on two consecutive assessments conducted at least 4 weeks apart.~The 95% Confidence Interval (CI) was calculated using the normal approximation to the binomial distribution."|Up to 102 weeks|Randomized Patients with Measurable Disease at Baseline||percentage of participants||95% Confidence Interval|Number
144233|NCT00434252|Secondary|Number of Participants With Objective Response|Objective response was assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and was inclusive of complete and partial response determined on two consecutive investigator assessments conducted ≥ 4 weeks apart.|Up to 102 weeks|Intent-to-treat (randomized) population.||participants|||Number
144234|NCT00434252|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. Median OS was estimated using the Kaplan−Meier method. For patients without documentation of death, overall survival will be censored at the time of the last known contact.|Up to 102 weeks|Intent-to-treat (randomized) population||months||95% Confidence Interval|Median
144235|NCT00434252|Primary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan−Meier method.|From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.|Intent-to-treat (randomized) population. For patients without documentation of disease progression or death on study, PFS was censored at the time of the last tumor assessment.||months||95% Confidence Interval|Median
144236|NCT00434226|Secondary|Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0|60 days following the last administration of study treatment|Treated patients||participants|||Number
152562|NCT00364845|Secondary|Mean Hemoglobin During the Evaluation Period||Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data||g/L||95% Confidence Interval|Mean
144240|NCT00434226|Primary|Best Response|The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.|From randomization until disease progression/recurrence|Randomized patients with at least one scan available at baseline and post-baseline||participants|||Number
144241|NCT00434213|Secondary|Contact Sensitization to Methylphenidate|Contact sensitization to methylphenidate through skin patch testing.|7 weeks|Safety population||Participants|||Number
144242|NCT00434213|Primary|Dermal Reactions|Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.|7 weeks|Safety population||Participants|||Number
144243|NCT00434161|Secondary|Incidence of Second Primary Malignancies or Other Malignancies|All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit – yes, no, no assessment –, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.|During long-term follow up phase (maximum of 10 years)|total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.||participants|||Number
144244|NCT00434161|Secondary|Time Death or Disease Progression|For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.||months||Inter-Quartile Range|Median
144245|NCT00434161|Secondary|Progression Free Survival|Progression-free survival (PFS) is the length of time during and after the treatment during which the disease being treated does not get worse. In this study the event for Progression-free survival was death from all causes or disease progression. Time to each event was defined as the time elapsed between the date of the first dose of investigational product, and the date of the given event.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.||Months||Inter-Quartile Range|Median
144246|NCT00434161|Primary|Incidence of Cataract Development or Progression at Month 12.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|12 months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group.||Participants|||Number
144247|NCT00434161|Secondary|Overall Survival|Overall survival (OS) is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse.|During long-term follow up phase (maximum of 10 years)|A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47||Months||Inter-Quartile Range|Median
144248|NCT00434161|Secondary|Incidence of Adverse Events and Laboratory Abnormalities|Incidence of Adverse Events CTCAE grade 3 or higher reported|at Day 32|||Participants|||Number
144249|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 12.|To study if the treatment has effected on the visual acuity from baseline to months 12, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Month 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||participants|||Number
144304|NCT00433771|Secondary|Stent Patency at 6 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).|6 Months|23 patients reached the Month 6 follow up point and were evaluated for stent patency.||Participants|||Number
144250|NCT00434161|Secondary|Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 6|To study if the treatment has effected on the visual acuity from baseline to months 6, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||participants|||Number
144251|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 12.|"To study the change in cataract from baseline visit to months 12, regarding the three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 12|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||units on a scale||Standard Deviation|Mean
144252|NCT00434161|Secondary|Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 6.|"To study the change in cataract from baseline visit to months 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale.~To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in theLOCS III score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each."|Months 6|All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.||units on a scale||Standard Deviation|Mean
144253|NCT00434161|Secondary|Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 12|"To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior (P), Cortical Cataract (C) and Nuclear Opalescence (NO).~For Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference."|at Month 6 and Month 12|281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 [77.3%] in the placebo, 52/79 [65.8%] in the palifermin. Month 12: 66 completed (14/22 [63.6%] in the placebo, 52/79 [65.8%] in the palifermin group.||participants|||Number
144254|NCT00434161|Secondary|Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.|Number of participants from the primary cataract subset showing an increase from baseline of >= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).|6 Months|Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.||participants|||Number
144255|NCT00434161|Secondary|The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.|"The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=no findings or erythema only, 1=soreness present with or without erythema, 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32."|at Day 32|||units on a scale * days||Standard Deviation|Mean
144256|NCT00434161|Secondary|Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The duration of ulcerative mucositis measured the number of days the participants had different WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally. Patients that did not have any ulcerative mucositis were given a value of 0 days."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.||Days||Full Range|Mean
144257|NCT00434161|Secondary|Incidence Ulcerative Mucositis (WHO Grades 2, 3, and 4)|"The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:~2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.||participants|||Number
144258|NCT00434161|Primary|Maximum Severity of Oral Mucositis (World Health Organization (WHO) Grades 0/1, 2, 3, or 4)|"For the primary efficacy endpoint maximum severity of Oral Mucositis (OM) was assessed, the number of participants who had the different severity. To assess severity of OM, a 5-grade WHO scale (0, 1, 2, 3, or 4) was used.~0 = no findings or erythema only, 1= soreness present with or without erythema, 2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally."|at Day 32|Full analysis set that includes all randomized subjects, and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.||Participants|||Number
144259|NCT00434148|Secondary|Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score|A Cushing's syndrome health related quality of life (HRQL) questionnaire was completed. The Cushing’s Syndrome HRQL questionnaire contains 12 sentences with 5 possible answers each. The answers are based on Likert scales, with 5 response categories: Always, Often, Sometimes, Rarely and Never; or Very much, Quite a bit, Somewhat, Very little, and Not at all. The answers to each of the items are rated on a scale of 1 to 5. “1” corresponds to the response category “Always” or “Very much” and “5” corresponds to the category “Never” or “Not at all”. The score is the sum of all item responses and can range from 12 to 60 points. The lower the score, the greater the Cushing's Syndrome impacts on HRQoL. A positive change from baseline indicates improvement.|baseline, 3 months, 6 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage change in HRQL score||Standard Deviation|Mean
144260|NCT00434148|Secondary|Change From Baseline in Tumor Volume|Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement.|baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||cm^3||Standard Deviation|Mean
144261|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition|Body composition as in percentage of body fat by region was assessed by total body scan. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||Percentage of body fat||Standard Deviation|Mean
144262|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)|BMD was measured using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L1-L4), proximal femur (total hip) and proximal femur (femur neck). A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||mg/cm^3||Standard Deviation|Mean
144263|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score|The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score >= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|||score on a scale||Standard Deviation|Mean
144264|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score|"The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows:~0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement."|baseline, month 3, month 6, month 12, month 18, month 24|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||score on a scale||Standard Deviation|Mean
144265|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides|Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||mmol/L||Standard Deviation|Mean
144266|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference|Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||cm||Standard Deviation|Mean
144267|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)|BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||kg/m^2||Standard Deviation|Mean
144268|NCT00434148|Secondary|Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)|Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement.|baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||mmHg||Standard Deviation|Mean
144269|NCT00434148|Secondary|Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)|Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||percent change||Standard Deviation|Mean
144270|NCT00434148|Secondary|Percent Change From Baseline in Serum Cortisol|Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.|baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||Percent change||Standard Deviation|Mean
144271|NCT00434148|Secondary|Time to First UFC Response|Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.|12 months|Full Analysis Set (FAS): The full analysis set included all randomized participants who received at least one dose of study drug.||months||Inter-Quartile Range|Median
144272|NCT00434148|Secondary|Change From Baseline in mUFC|Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.|baseline, 3 months, 12 months|Only participants from the full analysis set, who had measurements at baseline and the post baseline time point, were included in the analysis for that post baseline time point. The full analysis set included all randomized participants who received at least one dose of study drug.||nmol/24h||Standard Deviation|Mean
144273|NCT00434148|Primary|Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group|A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.|6 months|The full analysis set (FAS) was the primary population for efficacy and consisted of all 162 randomized patients who received at least one dose of paseriotide.||Responders||95% Confidence Interval|Number
144274|NCT00434122|Secondary|Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)|An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day.|7 days after hCG injection|Subjects with evaluable endometrial biopsies 7 days after injection with hCG.||Participants|||Number
144275|NCT00434122|Primary|Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)|"Explanation of the term coefficient of variation: The coefficient of variation is a normalized measure of dispersion of a probability distribution."|Stimulation Day 1|||Percentage||Standard Deviation|Mean
144276|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at 4 Years|Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|48 months|All Participants||percentage of participants||95% Confidence Interval|Number
144277|NCT00434109|Secondary|Number of Participants Requiring Dose Reduction|Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.|12 months|All participants||participants|||Number
144278|NCT00434109|Secondary|Number of Participants With Biochemical Response|Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.|12 months|All Participants||participants|||Number
144279|NCT00434109|Secondary|Number of Participants With Partial Radiographic Response|Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD.|12 months|All Participants||participants|||Number
144280|NCT00434109|Secondary|Percentage of Participants With Overall Survival (OS) at One Year|Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.|12 months|All participants||percentage of participants||95% Confidence Interval|Number
144893|NCT00429364|Secondary|Annual Rate of Change in Weight-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose weight-for-age z-scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
144281|NCT00434109|Primary|Percentage of Participants With Progression Free Survival (PFS) at 12 Months|Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started.|12 months|All participants||percentage of participants||95% Confidence Interval|Number
144282|NCT00434057|Secondary|Exploratory Analyses||Within 365 days of Data Lock||02/2010||||
144283|NCT00434057|Secondary|Biopsy Ratio|Number of lesions bioopsied to melanomas detected|Within 120 days of Data Lock||12/2009||||
144284|NCT00434057|Primary|Sensitivity and Specificity|Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.|Within 120 days of Data Lock|All participants with eligible and evaluable lesions were used in analysis of primary outcome measures||Ratio * 100||95% Confidence Interval|Mean
144285|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Economic Self-Sufficiency Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Economic Self-Sufficiency subscale measures the ability to sustain customary socio-economic activity and independence.|long term (1 year)|||units on a scale||Standard Deviation|Mean
144286|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Social Integration Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Social Integration Subscale measures the ability to participate in and maintain customary social relationships.|long term (1 year)|||units on a scale||Standard Deviation|Mean
144287|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Occupation Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Occupation Subscale measures the ability to occupy time in the manner customary to that person's sex, age, and culture.|long term (1 year)|||units on a scale||Standard Deviation|Mean
144288|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Mobility Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Mobility Subscale measures the ability to move about effectively in his/her surroundings.|long term (1 year)|||units on a scale||Standard Deviation|Mean
144289|NCT00434018|Secondary|Craig Handicap Assessment and Reporting Technique (CHART): Physical Independence Subscale|Use as a measure of handicap that captures the interaction of the person and the environment, and of community reintegration and participation. The CHART quantifies handicap by evaluating five domains: physical independence, mobility, occupation, social integration, and economic self-sufficiency. The CHART is made up of 27 questions with responses that are countable or in a yes/no format. Each of the five subscales has a maximum score of 100, and they may be summed to form a total score. High scores indicate lesser handicap. The CHART was developed as a specific instrument to measure handicap, is the only measure of that concept validated specifically for persons with SCI, and is currently the most widely used measure related to community reintegration in SCI. The Physical Independence subscale measures the ability to sustain a customarily effective independent existence.|long term (1 year)|||units on a scale||Standard Deviation|Mean
144290|NCT00434018|Primary|Wheelchair Skills Test (WST)|The WST is a standardized evaluation method that permits a set of representative wheelchair skills to be objectively, simply and inexpensively documented. The WST is an instrument for the objective evaluation of wheelchair skills. The WST consists of a series of commonly used wheelchair skills spanning the spectrum from those as basic as applying brakes to those as difficult as climbing curbs and performing wheelies. The WSC encompasses 57 skills (in Version 4.1) which result in a total score. The WST provide a pass-fail score for each skill. Refusal to attempt a skill (e.g. because of fear) constitutes a failing grade. The numerator is the Total Raw Score (i.e., the number of individual skills awarded a passing score) and the denominator is the number of applicable skills (i.e., the total number of skills minus those awarded NP scores). 100% is the maximum possible percentage score.|long term (1 year)|||units on a scale||Standard Deviation|Mean
144291|NCT00433914|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data.||Number of subjects|||Number
144292|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Percentage of subjects||95% Confidence Interval|Number
144293|NCT00433914|Secondary|Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||µg/mL||95% Confidence Interval|Geometric Mean
144294|NCT00433914|Secondary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Geometric mean titers||95% Confidence Interval|Geometric Mean
144295|NCT00433914|Secondary|Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|One month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Percentage of subjects||95% Confidence Interval|Number
144296|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set.||Percentage of subjects||95% Confidence Interval|Number
144297|NCT00433914|Primary|Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ|Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).|Baseline and one month after second and third vaccination|Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.||Percentage of subjects||95% Confidence Interval|Number
144298|NCT00433836|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients|The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients.|Baseline and Week 8|A subset of approximately 100 - 150 patients from selected centers was expected to undergo Ambulatory Blood Pressure Monitoring at baseline (Week 0) and at Week 8; however, only 56 patients chose to participate in this aspect of the study.||mm Hg||Standard Deviation|Mean
144299|NCT00433836|Secondary|Decrease in MSSBP to < 95th Percentile for Age, Gender and Height|The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.|at week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.||Percentage of participants|||Number
144300|NCT00433836|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.||mm Hg||Standard Error|Least Squares Mean
144301|NCT00433836|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.|Baseline and Week 12|Intent-to-treat. Only patients who had both baseline and endpoint values are included.||mm Hg||Standard Error|Least Squares Mean
144302|NCT00433771|Secondary|Number of Device-Related Adverse Events|Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.|Until 6 months or death|The intent-to-treat cohort of 58 patients was used for this analysis. Of all the events reported for this population, only 6 events were reported as device-related.||Events|||Number
144305|NCT00433771|Secondary|Stent Patency at 3 Months|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).|3 Months|34 patients reached the Month 3 follow up point and were evaluated for stent patency.||Participants|||Number
144306|NCT00433771|Secondary|Stent Patency at 1 Month|Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.|1 month|45 out of 55 evaluable patients had both bilirubin and obstructive symptom assessment at Month 1.||Participants|||Number
144307|NCT00433771|Secondary|Bilirubin Level Reduction|Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.|1 month|45 out of 55 evaluable patients reported a baseline and a Month 1 total bilirubin level and were therefore analyzed for bilirubin levels reduction.||Participants|||Number
144308|NCT00433771|Secondary|Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.|6 months|23 out of 55 evaluable subjects reached the 6-Month follow up visit and were assessed for reduction of biliary obstructive symptoms compared to baseline.||Participants|||Number
144309|NCT00433771|Secondary|Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.|3 months|34 out of 55 evaluable subjects reached the 3-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms compared to baseline.||Participants|||Number
144310|NCT00433771|Secondary|Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms|Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.|1 Month|49 out of 55 evaluable subjects reached the 1-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms.||Participants|||Number
144311|NCT00433771|Secondary|Re-interventions|Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.|Until 6 months or death|The re-intervention rate was assessed in the evaluable cohort of 55 patients.||Participant|||Number
144312|NCT00433771|Secondary|Ability to Successfully Remove a Stent Upon Removal Attempt|The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.|6 months|2 patients of the evaluable cohort (n=55) were assessed for success of stent removal without any complications/technical difficulties.||Participants|||Number
144313|NCT00433771|Secondary|Technical Success|Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.|At treatment|Device Safety and Technical Success were evaluated for the 58 intent-to-treat patients||participants|||Number
144314|NCT00433771|Primary|Adequate Clinical Palliation of the Biliary Obstruction|Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.|6 months|Per protocol, assessment of the primary endpoint was performed on the evaluable cohort, defined as group of patients who signed the Informed Consent Form, met eligibility criteria, received a stent and had at least one week of follow up.||participants|||Number
144315|NCT00433745|Secondary|Disease Response|Clinical response of underlying malignancy to the vaccination|7 weeks after last dose of vaccine|||participants|||Number
144316|NCT00433745|Primary|Cellular Immune Response|Minimum criterion for a cellular immune response was defined as the emergence of detectable T cell frequency against Willm's tumor 1 (WT1) when the pre-study analysis found no response, or a twofold increase in T cell frequency at any post vaccination time point|7 weeks after last dose of vaccine|||participants|||Number
144317|NCT00433654|Secondary|Ventricular Sensed Amplitude|Average ventricular sensed amplitude.|3 or 4 months post-implant|||millivolt (mV)||Standard Deviation|Mean
144318|NCT00433654|Secondary|Atrial Sensed Amplitude|Average atrial sensed amplitude.|3 or 4 months post-implant|||millivolt (mV)||Standard Deviation|Mean
144319|NCT00433654|Secondary|Ventricular Pacing Capture Threshold|Average ventricular pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant|||Volts||Standard Deviation|Mean
144320|NCT00433654|Secondary|Atrial Pacing Capture Threshold|Average atrial pacing capture threshold. Pacing capture threshold is the energy needed to pace the heart.|3 or 4 months post-implant|Includes all subjects with data.||Volts||Standard Deviation|Mean
144813|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percentage of subjects|||Number
144321|NCT00433654|Secondary|Ventricular Lead Handling Rating|Physicians' rated ventricular lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included||Units on a scale||Standard Deviation|Mean
144322|NCT00433654|Secondary|Atrial Lead Handling Rating|Physicians' rated atrial lead handling during the implant on a scale of -3 to +3 where: -3 = well below expectations; -2 = moderately below expectations; -1 = slightly below expectations; 0 = met expectations; +1 = slightly above expectations; +2 = moderately above expectations; and +3 = well above expectations.|During implant|All surveys completed are included||Units on a scale||Standard Deviation|Mean
144323|NCT00433654|Secondary|Ventricular Lead Impedance Change|Subjects' ventricular lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included||ohms||Standard Deviation|Mean
144324|NCT00433654|Secondary|Atrial Lead Impedance Change|Subjects' atrial lead impedance (a measure of electrical resistance) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Both measurements were conducted by the pacemaker. The difference between the two is reported.|9-12 week visit and 4-month visit|Subjects with non-missing data are included||ohms||Standard Deviation|Mean
144325|NCT00433654|Secondary|Occurrence of Arrhythmias|Number of participants with sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan that were considered attributable to the MRI scan|During the MRI scan|Arrhythmia was defined as heart rate > 150 beats per minute for > 30 seconds. Asystole was defined as standstill 6 seconds in electrical activity of the heart. Episodes were assessed via pulse oximetry monitoring during MRI scans.||participants|||Number
144326|NCT00433654|Secondary|System Related Adverse Device Effects Due to Labeling Instructions|Number of participants with adverse device effects (ADEs) that resulted from insufficiencies or inadequacies in the instructions for use or deployment of the device, or from user error. ADE's were investigator-reported.|Implant through 18 months post-implant|Includes all subjects undergoing an MRI using the instructions in the protocol.||participants|||Number
144327|NCT00433654|Secondary|Subjects With System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to 4 Months|All implanted subjects with either a 4-month follow-up or a system-related complication within the first 4 months post-implant are included.||participants|||Number
144328|NCT00433654|Primary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude (the minimum energy produced by the heart's ventricle that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 5.0 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week ventricular sensed amplitude was less than 5.0 mV.||participants|||Number
144329|NCT00433654|Primary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude (the minimum energy produced by the heart's atrium that the pacemaker can sense) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their sensed amplitude did not decrease by more than 50% and remained above 1.5 millivolts (mV).|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial sensed amplitude measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol; or if their 9-12 week atrial sensed amplitude was less than 1.5 mV.||participants|||Number
144330|NCT00433654|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold (the energy sent from the pacemaker needed to make the heart's ventricle beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have ventricular pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.||participants|||Number
144331|NCT00433654|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold (the energy sent from the pacemaker needed to make the heart's atrium beat) was measured at the 9-12 week visit (before the MRI scan was performed for those in the MRI group) and at the 4-month visit (one month post-MRI). Subjects were considered successful if their pacing capture threshold did not increase by 1.0 volt (V) or more.|9-12 week visit to 4-month visit|Subjects were excluded from this analysis if: they did not have atrial pacing capture threshold measurements at 9-12 weeks or 4 months; or (for the MRI group) their MRI scan was not done according to protocol.||participants|||Number
144332|NCT00433654|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|Subjects with a complication related to the MRI scan. All adverse events in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee. The committee determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the MRI scan.|MRI scan to one-month post-MRI scan|Subjects who underwent an MRI scan following study protocol-specified instructions are included. Of the 243 subjects who completed a one-month post-MRI (4-month) visit, 32 did not complete the MRI scan according to the protocol instructions, and are not included.||participants|||Number
144894|NCT00429364|Secondary|Annual Rate of Change in Weight||Up to 3 years following randomization.|||kg/year||Standard Error|Least Squares Mean
144333|NCT00433537|Secondary|3-year Overall Survival (OS)|OS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to death. Patients alive at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT||probability||95% Confidence Interval|Number
144334|NCT00433537|Secondary|2-year Progression-free Survival (PFS)|PFS for patients who received maintenance rituximab or ASCT after VcR-CVAD induction is defined as time from start of maintenance rituximab or ASCT to earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 6 months for 5 years, and then yearly thereafter.|Eligible and treated patients who received maintenance rituximab or ASCT||probability||95% Confidence Interval|Number
144335|NCT00433537|Primary|Complete Response (CR) Rate|Number of eligible, treated participants who achieve complete response. Response criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.|Assessed after VcR-CVAD cycles 2, 4, and 6.|Eligible and treated patients||proportion||95% Confidence Interval|Number
144336|NCT00433446|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 14 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
144337|NCT00433446|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Response) Among Those Patients With Measurable Disease|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. PSA = .2 ng/ml. Partial Response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.|Assessed every 3 cycles (1 cycle= 14 days) of treatment until progression|All eligible patients with measurable disease who started treatment were included in the analysis||participants|||Number
144338|NCT00433446|Secondary|Overall Survival (OS)|Measured from date of registration to date of death due to any cause or last contact|0-3 yeas after registration|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
144339|NCT00433446|Primary|Confirmed Prostate-Specific Antigen (PSA) Response|PSA response is defined as a 50% reduction in accordance with the recommendations of the orginal PSA Working Group. Confirmed PSA response is defined as PSA response at two or more time points at least 4 weeks apart, without objective disease progression or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
144340|NCT00433446|Secondary|Progression-free Survival (PFS)|PFS is defined as tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, PSA progression by PSA Working Group criteria, or symptomatic deterioration.|Assessed every 3 cycles (1 cycle = 14 days) until progression|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
144341|NCT00433381|Secondary|Predictive Value of CBV and Lac/NAA in Assessing 6-month Progression-free Survival||From randomization to six months.||||||
144342|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to Patient Response||From randomization to two weeks following initiation of bevacizumab.||||||
144343|NCT00433381|Secondary|Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to N-acetylaspartate (NAA) (Lac/NAA) Ratio||From registration to two weeks following initiation of bevacizumab.||||||
144344|NCT00433381|Secondary|Accuracy of Local Interpretation on the 6-month Progression-free Survival Using Central Review as the Reference Standard||From randomization to six months.||||||
144345|NCT00433381|Secondary|Agreement Between Local Interpretation and Central Interpretation of the Standard MRI on the 6-month Progression-free Survival|Assessed using a McNemar’s test. The sensitivity and specificity of the local interpretation of the 6-month progression-free survival will be estimated using the central review as the reference standard. In particular, for patients progressed at 6 months according to central review, the sensitivity of the local interpretation will be estimated and the exact confidence interval will be calculated. The specificity and the associated exact confidence interval of the local interpretation will be calculated in a similar way.|From randomization to six months.||||||
144346|NCT00433381|Secondary|Best Objective Response Rate (Complete Response, Partial Response, Stable Disease, Progression) in Both Arms|Only patients who have measurable disease present at baseline will be considered evaluable for response except those who are removed from the study before the end of cycle 1 for reasons other than clinical progression (such as toxicity). Tumor size will be measured in millimeters and is the largest crosssectional area using perpendicular measurements of contrast enhancing abnormality. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off corticosteroids, and neurologically stable or improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive MRI scans at least 1 month apart, corticosteroids stable or reduced, and neurologically stable or improved. Stable disease (SD): Does not qualify for CR, PR, or PD. Progression: ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased.|From randomization to progression, death, or last follow-up.||||||
144347|NCT00433381|Secondary|Six-month Progression-free Survival (Bevacizumab and Temozolomide Arm)||From randomization to six months.||||||
144348|NCT00433381|Primary|Rate of Treatment Discontinuation Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm)|If 6 or fewer of 29 patients stop treatment due to medical conditions, then null hypothesis of rate = 0.35 will be rejected, type I and type II error of 0.10. Alternative hypothesis rate of 0.15.|From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor).|The first 29 eligible patients who received protocol treatment were to be evaluated for treatment tolerability.||participants|||Number
144349|NCT00433381|Primary|Six-month Progression-free Survival (PFS) for Bevacizumab and Irinotecan Hydrochloride Arm|Progression-free survival is defined as time from randomization to date of progression or date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without progression are considered to be censored at the date of last contact.|From randomization to six months.|Eligible patients who were not removed from the study before the end of cycle 1 for reasons other than clinical progression (such as toxicity).||percentage of participants||95% Confidence Interval|Number
144350|NCT00433329|Primary|Number of Patients Reaching a 6-Minute Walk Test (6MWT) Distance ≥ 380 Meters|The 6MWT is a non encouraged test, which measures the walking distance covered over a 6 minute period|at 16 weeks and at 28 weeks of a stepped approach to therapy|Intention to treat population||participants||95% Confidence Interval|Number
144351|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation in Nonresponders|Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.|over 13 Weeks|Number of randomized participants who were nonresponders at Visit 4 (7 weeks).||participants|||Number
144352|NCT00433290|Secondary|Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint|Response was defined as a >=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a <30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.|13 Weeks|Number of randomized participants who were non-responders at Visit 4 (7 weeks) and with non-missing response values.||participants|||Number
144353|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders|"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).~Non-Responders were defined as patients with a <30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score."|Baseline and 13 Weeks|Number of participants who did not respond to treatment after 6 weeks of treatment.||units on a scale||Standard Deviation|Mean
144354|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||kilograms||Standard Deviation|Mean
144355|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||mm Hg||Standard Deviation|Mean
144356|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||beats per minute||Standard Deviation|Mean
144357|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride||Baseline and 13 Week Endpoint|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||millimole per Liter||Standard Deviation|Mean
144358|NCT00433290|Secondary|Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes||Baseline and 13 Weeks|Number of participants with a baseline and at least one non-missing post-baseline value.||Units/Liter||Standard Deviation|Mean
144359|NCT00433290|Secondary|Adverse Events Reported as Reason for Discontinuation||over 13 weeks|All randomized participants.||participants|||Number
144360|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144361|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144362|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144363|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144364|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144365|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144366|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144367|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity|A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144368|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|The number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144369|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144370|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144371|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144372|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)|A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144373|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|All randomized participants. Intent-to-treat analysis.||units on a scale||Standard Deviation|Mean
144374|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire – 5 Dimension (EQ-5D)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144375|NCT00433290|Secondary|Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores|MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30.|Baseline and 13 Weeks|Number of randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144376|NCT00433290|Secondary|Number of Participants Who Responded to Treatment at 13 Week Endpoint|Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|13 Weeks|Number of randomized participants with non-missing response values.||participants|||Number
144377|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144378|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores|This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144379|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144380|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|All randomized participants with baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144381|NCT00433290|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|All randomized participants with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144382|NCT00433290|Secondary|Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|All randomized participants with at least one non-missing post-baseline value.||units on a scale||Standard Deviation|Mean
144383|NCT00433290|Primary|Change in Brief Pain Inventory (BPI) 24-hour Average Rating|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.|Baseline, Week 4, Week 7, Week 13|All randomized participants. Intent-to-treat analysis.||units on a scale||Standard Error|Least Squares Mean
144384|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose.|2 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
144385|NCT00432237|Secondary|Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose|Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)||Participants|||Number
144386|NCT00432237|Primary|Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
144387|NCT00432237|Primary|Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
144388|NCT00432237|Primary|Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose|Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
144389|NCT00432237|Primary|Number of Patients Reporting Pain Relief at 2 Hours Post Dose|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose.~Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
144390|NCT00432237|Secondary|Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose|Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.|2 to 24 hours postdose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours and who either 1) did not have pain freedom at any time between 2 and 24 hours postdose, 2) used rescue medication between 2 and 24 hours postdose or 3) answered the 24 hour recurrence question (a question that ascertains recurrence of migraine pain)||Participants|||Number
144391|NCT00432237|Primary|Number of Patients Reporting Pain Freedom at 2 Hours Postdose|"Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose.~Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain."|2 hours post dose|All randomized, treated patients who have at least one post-dose measurement at or prior to 2 hours.||Participants|||Number
144392|NCT00431184|Secondary|Young Mania Rating Scale (YMRS)|The YMRS is used to assess manic symptoms. There are 11 questions which ask the patient to rate the severity of symptoms. Scores range from 0 to a maximum of 60. All questions are rated based on severity, with a higher score signifying increased severity. Questions 1-4, 7, and 10 are rated on a 0-4 scale. Questions 5, 6, 8, and 9 are rated on a 0-8 scale.|at the time of administration of intervention and 5 hours following administration of intervention|||units on a scale||95% Confidence Interval|Mean
144393|NCT00431184|Primary|Mania Acute Rating Scale (MACS)|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment administration were averaged. The number below represents the average mean change.|On Day 1 and Day 2, at the time of administration of intervention and 5 hours following administration of intervention|||units on a scale||95% Confidence Interval|Mean
144394|NCT00431132|Secondary|Transvaginal Ultrasound: Endometrial Thickness|Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.|Week 0, week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.||mm||Standard Deviation|Mean
149292|NCT00394654|Secondary|Time to Observed Maximum Nasal Lavage Concentration (Tmax)|Tmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
144395|NCT00431132|Primary|Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies|The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.|Week 52|Safety analyses using LOCF (last observation carried forward) were performed on the safety population, which was comprised of 336 (100%) subjects who received 52 weeks of treatment with Vagifem® 10 mcg of trial drug.||percentage of participants|||Number
144396|NCT00431067|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|From first OR to time of progression or death|TS - patients with OR only.||days||Standard Deviation|Mean
144397|NCT00431067|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|From first dose of study medication to time when OR measurement was taken.|TS. There were only 4 patients who responded.||days||95% Confidence Interval|Median
144398|NCT00431067|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.|From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month|TS (14 patients died)||days||95% Confidence Interval|Median
144399|NCT00431067|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month|TS||days||95% Confidence Interval|Median
144400|NCT00431067|Primary|Objective Response (OR)|Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .|From first dose of study medication to response measurement, up to 34 month|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.||Participants|||Number
144401|NCT00431041|Secondary|Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline."|Baseline and 8 weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study||urgency episodes per day||Standard Deviation|Mean
144402|NCT00431041|Secondary|Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary|"Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.~The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline."|Baseline and 8 Weeks|Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study||Micturitions per day||Standard Deviation|Mean
144403|NCT00431041|Primary|The Severity of Dry Mouth Reported as an Adverse Event|"The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).~Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water)"|8 weeks|Data represents ITT Population: all randomized subjects||participants|||Number
144404|NCT00431041|Primary|The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event|The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit|8 weeks|Data represents ITT Population: all randomized subjects||participants|||Number
144405|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.|The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 364|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364.||Percentage of subjects||95% Confidence Interval|Number
144406|NCT00433199|Secondary|Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.|The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.|Day 266|The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266.||Percentage of subjects||95% Confidence Interval|Number
144407|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.|Day 182|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182.||Percentage of subjects||95% Confidence Interval|Number
144408|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results|Day 56|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56.||Percentage of subjects||95% Confidence Interval|Number
146440|NCT00418015|Primary|Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention|Visual analog pain scale (0 to 100) at 1st request for supplemental analgesia|VAS at analgesia request|Analysis population per protocol.||Units on a scale||Inter-Quartile Range|Median
144409|NCT00433199|Secondary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14|Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results|Day 14|The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14.||Percentage of subjects||95% Confidence Interval|Number
144410|NCT00433199|Primary|Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112|Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results|Day 112|The analysis was done on the Full analysis sample defined as the subjects who were included in the Safety Sample and who had data for at least one post-Baseline assessment of any efficacy measurement up to and including Day 182 (double-blind period). The number correspond to the number of subjects having a measurement at Day 112;||Percentage of subjects||95% Confidence Interval|Number
144411|NCT00433160|Secondary|Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks|Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement.||participants|||Number
144412|NCT00433160|Secondary|Fractures by Investigators Assessment During Entire Study Period of 104 Weeks|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline Through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||number of fractures|||Number
144413|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks|Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least on post-treatment measurement. The n's are the number of participants with fractures.||number of fractures|||Number
144414|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in CTX||Standard Deviation|Mean
144415|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in BAP||Standard Deviation|Mean
144416|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in PINP||Standard Deviation|Mean
144417|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144418|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144419|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144420|NCT00433160|Secondary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline, 76 Weeks, 104 Weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144421|NCT00433160|Secondary|Back Pain Severity|Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).|Baseline, Weeks 12, 24, 36, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||participants|||Number
144422|NCT00433160|Secondary|Fractures by Investigators Assessment|"Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be fragility if they occurred without trauma."|Baseline through 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||number of fractures|||Number
144423|NCT00433160|Secondary|Vertebral Fractures by Central X-ray Assessment|Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.|Baseline through 52 weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement. The n's are the number of participants with fractures.||number of fractures|||Number
144424|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism – Serum Type I Collagen Crosslinked C-telopeptide (CTX)|Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in CTX||Standard Deviation|Mean
144425|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)|Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in BAP||Standard Deviation|Mean
144426|NCT00433160|Secondary|Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)|Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.|Baseline to Weeks 4, 12, 24, and 52|Number of randomized participants with at least one dose of study drug and with at least one post-treatment measurement.||percent change in PINP||Standard Deviation|Mean
144427|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Femoral Neck|Percent change in bone mineral density at femoral neck from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144428|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Total Hip|Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144429|NCT00433160|Secondary|Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)|Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.|Baseline to 52 Weeks|Number of randomized participants who received at least one dose of study drug and with at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144430|NCT00433160|Primary|Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)|Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.|Baseline to 52 weeks|Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.||percent change in BMD||Standard Deviation|Mean
144431|NCT00433017|Secondary|Mean Change in Central Retinal Thickness of the Study Eye at Month 12|Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.|Baseline and Month 12|Full analysis set, LOCF||μm||Standard Deviation|Mean
144432|NCT00433017|Secondary|Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12|Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.|Baseline and Month 12|Full analysis set based on observed data.||mm^2||Standard Deviation|Mean
144433|NCT00433017|Secondary|Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12|The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).|Month 12|The Full Analysis Set (FAS) based on observed data.||Percentage of participants|||Number
144434|NCT00433017|Primary|Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit|The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.|Month 2 to Month 11|Full analysis set. Includes number of participants in the treatment group with at least one visit assessment of re-treatment.||Percentage of Participants|||Number
144435|NCT00433017|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.|Baseline and Month 12|Performed on the Full analysis set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. FAS consisted of all patients as randomized that received at least one application of study drug and had at least one post-baseline assessment for best corrected visual acuity in the study eye.||Letters||Standard Deviation|Mean
144436|NCT00432835|Primary|Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis|Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.|Study Day 0 (Baseline), Day 4, Day 8|||percentage of radiolabeled meal in stoma||Standard Error|Mean
144437|NCT00432835|Primary|Symptom of Nausea Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7|||Patient Self-reported Symptom Score||Standard Error|Mean
144438|NCT00432835|Primary|Symptom of Vomiting Associated With Gastroparesis|Likert Scale 0-4 (low-high) using a patient reported outcomes tool|Study Day 0 (Baseline), Day 3, Day 7|||Patient Self-reported Symptom Score||Standard Error|Mean
144453|NCT00432809|Secondary|Body Mass Index (BMI)|Body Mass Index (BMI) at 12 months measured as kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg/m2||Standard Deviation|Mean
144439|NCT00432809|Secondary|Cardiovascular Medications - Anticoagulants|Number of participants taking anticoagulants at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144440|NCT00432809|Secondary|Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)|Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144441|NCT00432809|Secondary|Cardiovascular Medications - Beta Blocker|Number of participants taking Beta Blockers at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144442|NCT00432809|Secondary|Cardiovascular Medications - Lipid Lowering Agents|Number of participants taking Lipid lowering agents at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144443|NCT00432809|Secondary|Diabetes Medication - Use of Secretagogue|Number of participants taking Secretagogues at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144444|NCT00432809|Secondary|Diabetes Medication - Use of Incretin Mimetics|Number of participants taking Incretin Mimetics|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144445|NCT00432809|Secondary|Diabetes Medication - Use of Thiazolidinedione|Number of participants using thiazolidinedione at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144446|NCT00432809|Secondary|Diabetes Medication - Use of Biguanides|Number of participants taking Biguanides at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144447|NCT00432809|Secondary|Diabetes Medication - Use of Insulin|Number of participants taking insulin at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144448|NCT00432809|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)|Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/L||Inter-Quartile Range|Median
144449|NCT00432809|Secondary|Change in Triglycerides|Median percent change in triglycerides at 12 months from baseline measure|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/dL||Inter-Quartile Range|Median
144450|NCT00432809|Secondary|Change in High-density Lipoprotein (HDL)|Percent change in high-density lipoprotein (HDL) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/dL||Standard Deviation|Mean
144451|NCT00432809|Secondary|Change in Systolic Blood Pressure (SBP)|Change in Systolic Blood Pressure (SBP) at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mm Hg||Standard Deviation|Mean
144452|NCT00432809|Secondary|Change in Body Mass Index (BMI)|Change in Body Mass Index (BMI) at 12 months, measured in kg/m2|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg/m2||Standard Deviation|Mean
144814|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.||percentage of subjects|||Number
144454|NCT00432809|Secondary|Change in Body Weight From Baseline|Mean change in body weight from baseline measured in kilograms (kg)|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg||Standard Deviation|Mean
144455|NCT00432809|Secondary|Body Weight|Body weight in kilograms (kg) measured at 12 months|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||kg||Standard Deviation|Mean
144456|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications|The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144457|NCT00432809|Secondary|Glycated Hemoglobin (HbA1c)|Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||percentage points of glycated hemoglobin||Standard Deviation|Mean
144458|NCT00432809|Secondary|Fasting Plasma Glucose|Fasting Plasma Glucose measured in mg/dL.|1 year|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||mg/dL||Inter-Quartile Range|Median
144459|NCT00432809|Secondary|Change in Glycated Hemoglobin (HbA1c)|Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change|1 year - baseline|Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||percentage points of glycated hemoglobin||Standard Deviation|Mean
144460|NCT00432809|Secondary|The Cost-effectiveness of Each Program and the Side Effects and /or Complications.||1, 2, and 5 years.||||||
144461|NCT00432809|Secondary|Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.||1, 2, and 5 years||||||
144462|NCT00432809|Secondary|Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).||1, 2, and 5 years||||||
144463|NCT00432809|Primary|Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.|The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).|1 year|Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.||participants|||Number
144464|NCT00432744|Primary|Non-parametric Hotelling T-square Bivariate Analysis of GMGF 88 and OPeds QOL.|This is a multivariate analysis of the first two outcomes: Period 2 minus Period 1 GMFM88 and Peds Quality of Life, analyzed as follows: First, to be in the analysis, subjects must contribute at least one of these endpoints. Second, if the subject became totally disabled during period 1, the difference was defined as + infinity, (highest possible evidence favoring period 2), and if the subject became totally disabled in period 2, the subject was scored as - infinity (highest possible evidence favoring period 1). Period 2 minus period 1 differences were ranked form low to high with missing values scores at the mid-rank. The Hotelling T-square was computed on these ranks and the P-value was obtained from 100,000 rerandomizations as the fraction of rerandomizations with T-sq at least as large as that observed.|end of 12 month minus end of 6 month difference.|Subjects contributes at least one difference (either GMFM or Peds QOL). Thirteen contributed both and one each was missing GMFM or Peds QOL.||participants|||Number
144465|NCT00432744|Primary|Pediatric Quality of Life Scale|"The Pediatric Quality of Life Scale is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. Goggle pedsQL and Mapi to browse the copyrighted manual. A link to the instrument is included."|At 6 and 12 Months|7 subjects in each group were evaluable for this endpoint. The two subjects who became disabled are evaluable. One subject did not have period 2 Quality of Life data and is excluded.||units on a scale||Inter-Quartile Range|Median
144474|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144466|NCT00432744|Primary|McMaster Gross Motor Function (GMFM 88)|The McMaster Gross Motor Function is a validated scale ranging from 0 to 100 (the higher the better). Since there was the possibility of a subject becoming totally disabled our FDA peer reviewed design called for its use as follows: If the subject completed both periods, the score was calculated as the difference in scores between the end of Period 2 (at 12 months) minus that at the end of Period 1 (6 months). If a subject became totally disabled, this difference was considered as plus infinity if it occurred in period 1 (Penalizes period 1), and minus infinity if it occurred in Period 2 (Penalizes period 2). The two treatments were compared via the Wilcoxon test, and the effect size was estimated using Kendall's Tau-B. This is interpreted in a similar manner to correlation with positive values favoring COQenzyme10 and negative values favoring placebo. One of the links in this report is to the the GMFM scale and how it is scored. A link to the instrument is included.|Taken at 6 and 12 Months|||units on a scale||Inter-Quartile Range|Median
144467|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144468|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144469|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Applying a Splint on the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144470|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144471|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144472|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144473|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144485|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144853|NCT00429793|Primary|Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)||Up to 5 years||||||
144475|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Armpit of the Affected Arm"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144476|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144477|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144478|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cutting the Fingernails of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144479|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144480|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144481|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Carer Burden Scale for Domain Cleaning the Palm of the Affected Hand"|The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by baseline value, i.e. zero change||Participants|||Number
144482|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144483|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144484|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144612|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
144486|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Pain"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144487|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144488|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144489|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144490|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144491|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Limb Position"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144492|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144493|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144494|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144495|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144496|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Dressing"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144497|NCT00432666|Secondary|"Change From Baseline to Final Visit in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144498|NCT00432666|Secondary|"Change From Baseline to Week 12 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144499|NCT00432666|Secondary|"Change From Baseline to Week 8 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144500|NCT00432666|Secondary|"Change From Baseline to Week 4 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144501|NCT00432666|Secondary|"Change From Baseline to Week 2 in the Disability Assessment Scale for Domain Hygiene"|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144502|NCT00432666|Secondary|Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144503|NCT00432666|Secondary|Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144504|NCT00432666|Secondary|Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144505|NCT00432666|Secondary|Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144506|NCT00432666|Secondary|Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144507|NCT00432666|Secondary|Carer's Global Assessment of Efficacy|The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144508|NCT00432666|Secondary|Patient's Global Assessment of Efficacy|The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144509|NCT00432666|Secondary|Investigator's Global Assessment of Efficacy|The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.|Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144510|NCT00432666|Other Pre-specified|Onset of Treatment Effect [Classified]|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.~For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at baseline injection of the Main Period up to onset of treatment effect|"These results are a different presentation of the results of the secondary outcome measure Time to Onset of Treatment Effect. For subjects without any treatment effect the time to onset of effect was censored at the last visit."||Participants|||Number
144511|NCT00432666|Secondary|Duration of Treatment Effect|The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.|Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator|||Days||95% Confidence Interval|Median
144512|NCT00432666|Secondary|Time to Waning of Treatment Effect|Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was “no”. If the patient answered with “yes” he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero.|Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect|||Weeks||95% Confidence Interval|Median
144513|NCT00432666|Secondary|Time to Onset of Treatment Effect|"Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if yes: when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was yes or until the final visit of the Main Period was performed.~For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period."|Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect|"Results for placebo patients were not displayed because the upper limit of the confidence interval was not estimable (this can not be entered because a numeric entry is expected). The results of this analysis are therefore given as Onset of Treatment Effect [classified] under Other Pre-specified Outcome."||Days||95% Confidence Interval|Median
144514|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144515|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144516|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144517|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144518|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144519|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144520|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144521|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144522|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144523|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144609|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
144524|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144525|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144526|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144527|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144528|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144529|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144530|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144531|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144532|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144533|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144610|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
144534|NCT00432666|Secondary|Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144535|NCT00432666|Secondary|Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 12|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144536|NCT00432666|Secondary|Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 8|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144537|NCT00432666|Secondary|Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144538|NCT00432666|Secondary|Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2|Intention to treat (ITT) as defined as all randomized subjects||Participants|||Number
144539|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
144540|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
144541|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
144542|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
144543|NCT00432666|Secondary|Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
144544|NCT00432666|Secondary|Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were imputed by worst case, i.e. zero change||Participants|||Number
144545|NCT00432666|Primary|Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors|The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.|Baseline, Week 4|Intention to treat (ITT) as defined as all randomized subjects; missing values were not imputed||Participants|||Number
144546|NCT00432601|Primary|Knowledge|Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer.|Results visit (Time 2 - approximately 7-10 days after Time 1)|||percentage correct on a 12 item scale||Standard Error|Mean
144547|NCT00432562|Primary|Mean Residence Time (MRTinf)|MRT = (AUMCinf)/(AUCinf)|0-144 hours post-dose|||hours||Standard Deviation|Mean
144548|NCT00432562|Primary|Last Quantifiable Drug Concentration (Clast)||0-144 hours post-dose|||ng/mL||Standard Deviation|Mean
144549|NCT00432562|Primary|Time of Last Measurable Concentration (Tlast)||0-144 hours post-dose|||hours||Standard Deviation|Mean
144550|NCT00432562|Primary|Observed Terminal Elimination Half-Life (t1/2)|t1/2 = [ln(2)/λ z]|0-144 hours post-dose|||hours||Standard Deviation|Mean
144551|NCT00432562|Primary|Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)|Estimated via linear regression of the time versus log concentration|0-144 hours post-dose|||hr-1||Standard Deviation|Mean
144552|NCT00432562|Primary|Percentage of AUCinf Based on Extrapolation (AUCextrap)||0-144 hours post-dose|||% of participants||Standard Deviation|Mean
144553|NCT00432562|Primary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)|AUCinf = AUClast + (Clast/lamda z)|0-144 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
144554|NCT00432562|Primary|Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)|Determined Using the Linear Trapezoidal Rule|0-144 hours post-dose|||hr*ng/mL||Standard Deviation|Mean
144555|NCT00432562|Primary|Maximum Observed Plasma Concentration (Cmax)||0-144 hours post-dose|||ng/mL||Standard Deviation|Mean
144556|NCT00432562|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0-144 hours post dose|||hours||Standard Deviation|Mean
144557|NCT00432458|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|During treatment (up to 5 years)|||participants|||Number
144558|NCT00432458|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the time from randomization to the date at which the patient was removed from (protocol) treatment due to disease progression, unacceptable toxicity, participant refusal or death. The median TTF with 95% CI was estimated using the Kaplan Meier method|time from randomization to treatment failure (up to 5 years)|||months||95% Confidence Interval|Median
144559|NCT00432458|Secondary|Time to Subsequent Treatment|Time to subsequent treatment (TTS) was defined as time from end of active (protocol) treatment to the start of subsequent treatment for participants with progressive disease. The median TTS with 95% CI was estimated using the Kaplan Meier method|time from end of treatment to subsequent treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently across all participants.||years||95% Confidence Interval|Median
144560|NCT00432458|Secondary|Duration of Response (Complete Response, Partial Response, and Very Good Partial Response)|Duration of response (DOR) is defined as the time from first documentation of response (CR, VGPR or PR) to disease progression. The median DOR with 95% CI was estimated using the Kaplan Meier method|time from start of response to progression (up to 5 years)|Participants who achieved a confirmed response (CR, VGPR, or PR) as described above were analyzed.||years||95% Confidence Interval|Median
144561|NCT00432458|Secondary|Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment|"Response is defined as follows:~CR: Complete disappearance of M-protein from serum & urine on immunofixation, <5% plasma cells in bone marrow (BM)~VGPR: >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~PR: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|12 months|||participants|||Number
144562|NCT00432458|Secondary|12-month Progression-free Survival (PFS)|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of randomization.|12 months|||participants|||Number
144563|NCT00432458|Primary|Time to Disease Progression (TTP)|Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.|randomization to progression (up to 5 years)|Time to disease progression was analyzed on all randomized participants on an intent to treat basis.||years||95% Confidence Interval|Median
144564|NCT00432445|Primary|Rate of Local Control in the Globe at 12 Months|Where proton beam radiation therapy used as an alternative to external photon beam irradiation in children with retinoblastoma as a means of local tumor control and ocular retention, local tumor control measured for participants with a globe as tumor regression with ocular retention, and for post enucleation measured as lack of orbital tumor recurrence.|12 months|No analysis performed. Study did not meet anticipated enrollment.|||||
144565|NCT00432341|Secondary|Patient Assessment of Need for Retreatment at Week 4|"Patients were queried regarding their need for another injection of botulinum toxin type A for cervical dystonia. Patients were required to answer How would you rate your need for another injection of botulinum toxin type A for cervical dystonia using the following scale?. The response options included 'absolutely requires injection', 'very much requires injection', 'somewhat requires injection', and 'does not require injection'."|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at the time points are included.||Number of Responses|||Number
144566|NCT00432341|Secondary|Patient Visual Analog Assessment of Pain at Week 4|Patients were required to assess their pain using a Visual Analog Scale in reference to their current perception of pain at that visit. This scale consisted of a line measuring 100 mm, and patients were instructed to put a mark on the line at the point that best described 'How much pain you are having right now'. Higher scores denoted higher pain intensity: 0 indicated 'No pain' and 100 indicated 'Worst possible pain'.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
144567|NCT00432341|Secondary|Patient Comparison of Benefit to Previous Injections at Week 20|"Patients assessed the improvement in cervical dystonia after receiving the study treatment compared to previous treatment(s). Patients were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.||Number of Responses|||Number
144568|NCT00432341|Secondary|Physician Comparison of Benefit to Previous Injections at Week 20|"Physicians assessed the improvement in cervical dystonia after the study treatment compared to previous treatment(s) for each patient. Physicians were required to answer How would you rate the benefit of the current treatment of cervical dystonia with botulinum toxin type A compared to the previous treatment using the following scale?. The response options were 'much worse', 'worse', 'somewhat worse', 'same as previous', 'somewhat better', 'better', and 'much better'."|Week 20|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure. Only completed assessments at this time point are included.||Number of Responses|||Number
144569|NCT00432341|Secondary|Physician Assessment of Cervical Dystonia Severity at Week 4|Physician assessment of cervical dystonia severity. The rating was assessed on a scale of 0 to 10, with higher scores denoting greater severity: 0 represented 'No evidence of dystonia' and 10 represented 'Worst cervical dystonia ever'|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided as least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
144570|NCT00432341|Secondary|Global Assessment of Benefit by Physician at Week 4|Physician evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
144571|NCT00432341|Secondary|Global Assessment of Benefit by Patient at Week 4|Patient evaluation of benefit from botulinum toxin type A treatment for cervical dystonia. Ratings were on a scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (about 100% improvement)', 0 represented 'Unchanged', and -4 represented 'Very marked worsening (about 100% worse or greater)'.|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Units on a Scale||Full Range|Median
144572|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4|The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|Baseline, Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Scores on a Scale||Full Range|Median
144573|NCT00432341|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) at Week 4|The TDTS was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score representing a loss of 80% of the treatment benefit at Week 4. The TDTS is calculated from the TWSTRS score and ranges from 0 (least symptoms) to 68 (worst symptoms). The TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms).|Week 4|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Scores on a Scale||Full Range|Median
146441|NCT00418015|Secondary|Subjects With Pruritus at 24 Hours Post Morphine|Subjects reporting pruritus in the first 24 hours post cesarean delivery|24 hours post cesarean delivery|||participants|||Number
144574|NCT00432341|Primary|Duration of Treatment Benefit|Duration of treatment benefit was measured as the time (days) from Baseline until patients had a loss of therapeutic benefit, as defined by the achievement of their Toronto Western Spasmodic Torticollis Rating Scale Duration Target Score (TDTS) [loss of 80% of benefit].|20 Weeks|Modified Intent to Treat: included all patients who were randomized to treatment, received treatment at Visit 1, and provided at least 1 post-dose assessment measure.||Days||95% Confidence Interval|Median
144575|NCT00432276|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
144576|NCT00432276|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μmol/L||Standard Error|Least Squares Mean
144577|NCT00432276|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
144578|NCT00432276|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
144579|NCT00432276|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline IDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
144580|NCT00432276|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
144581|NCT00432276|Secondary|Change From Baseline in VLDL Particles|The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL particles as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
144582|NCT00432276|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron triglycerides as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144583|NCT00432276|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12, 26, 42 and 52.~Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline VLDL/chylomicron particles as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
144584|NCT00432276|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline NMR triglycerides as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144585|NCT00432276|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
144586|NCT00432276|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/L||Standard Error|Least Squares Mean
144587|NCT00432276|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/ml||Standard Error|Least Squares Mean
144588|NCT00432276|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in Apolipoprotein C-III was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144589|NCT00432276|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in Apolipoprotein B was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.|Baseline and Weeks 12, 26, 42 and 52.|Full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144590|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144591|NCT00432276|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144592|NCT00432276|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acids as covariates.|Baseline and Weeks 12, 26, 42, and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
144593|NCT00432276|Secondary|Change From Baseline in Triglycerides|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144594|NCT00432276|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144595|NCT00432276|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144596|NCT00432276|Secondary|Change From Baseline in Total Cholesterol|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144597|NCT00432276|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 4, 8, 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.|Baseline and Weeks 4, 8, 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||kg||Standard Error|Least Squares Mean
144611|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
144598|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
144599|NCT00432276|Secondary|Change From Baseline in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12, 26, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates."|Baseline and Weeks 12, 26, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
144600|NCT00432276|Secondary|Change From Baseline in C-peptide|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least squares means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
144601|NCT00432276|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin/insulin ratio as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ratio||Standard Error|Least Squares Mean
144602|NCT00432276|Secondary|Change From Baseline in Fasting Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting insulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μIU/mL||Standard Error|Least Squares Mean
144603|NCT00432276|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting proinsulin as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
144604|NCT00432276|Secondary|Percentage of Participants Meeting Hyperglycemic Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 7 days after the first sample and analyzed by the central laboratory:~After more than 2 weeks of treatment but prior to the Week 4 Visit: A single fasting plasma glucose (FPG) ≥275 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: A single FPG ≥250 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: A single FPG ≥225 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% AND ≤0.5% reduction in HbA1c as compared with the baseline HbA1c."|Baseline to Week 52|Full Analysis Set including patients with a postbaseline visit.||percentage of participants|||Number
144605|NCT00432276|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|Baseline to Week 52|Full Analysis Set including patients with at least one non-missing fasting plasma glucose result in each treatment group.||percentage of participants|||Number
144606|NCT00432276|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52. Least Squares Means were from an ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline FPG as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 34, 42 and 52.|The full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug and where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
144607|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
144608|NCT00432276|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
144887|NCT00429364|Secondary|Annual Rate of Change in Arm Span to Height Ratio||Up to 3 years following randomization.|All randomized participants whose arm span to height ratios were measured at baseline and at any of the follow-up visits.||1/year||Standard Error|Least Squares Mean
144613|NCT00432276|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Weeks 26 and 52 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Weeks 26 and 52.|The full analysis set. Patients who did not complete the scheduled Week 26 or Week 52 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
144614|NCT00432276|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 34 and 42.|Per-protocol set. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
144615|NCT00432276|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 and Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Weeks 26 and 52.|Per-protocol set included all randomized patients who received at least 1 dose of double-blind study medication and who had no major protocol violations. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
144616|NCT00432159|Secondary|Average Radiographic Disc Height (mm) - Change From Post-op||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||mm||Standard Deviation|Mean
144617|NCT00432159|Secondary|Global Cervical Range of Motion - Change From Baseline||24 months|As Treated. The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||degrees||Standard Deviation|Mean
144618|NCT00432159|Secondary|Subject Satisfaction|Subject Satisfaction (Would you have this procedure again?)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants|||Number
144619|NCT00432159|Secondary|Activity|Clinical Assessment of Activity|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants|||Number
144620|NCT00432159|Secondary|Return to Work|Estimated Proportion of Subjects Returning to Work|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||% of subjects who returned to work|||Number
144621|NCT00432159|Secondary|Work Status Assessment||24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants|||Number
144622|NCT00432159|Secondary|SF-36 - Mental Composite Scores (MCS) - Change From Baseline|Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
144623|NCT00432159|Secondary|SF-36 - Physical Composite Scores (PCS) - Change From Baseline|Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
144624|NCT00432159|Secondary|Dysphagia Disability Index - Change From Baseline|Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as “always” 4, “sometimes” 2, or “never” 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
144625|NCT00432159|Secondary|Average Shoulder Pain VAS - Change From Baseline|Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
146442|NCT00418015|Secondary|Severity of Pruritus Following Fentanyl|Severity of pruritus during labor analgesia|Labor analgesia|||participants|||Number
144626|NCT00432159|Secondary|Maximum Shoulder Pain VAS - Change From Baseline|Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
144627|NCT00432159|Secondary|Average Arm Pain VAS - Change From Baseline|Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
144628|NCT00432159|Secondary|Maximum Arm Pain VAS - Change From Baseline|Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Deviation|Mean
144629|NCT00432159|Secondary|Neck Pain VAS Scores - Change From Baseline|Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||Units on a scale||Standard Error|Mean
144630|NCT00432159|Secondary|NDI - Change From Baseline|Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||NDI Score||Standard Deviation|Mean
144631|NCT00432159|Secondary|Device-Related SAE Component of Success|no device related serious adverse events|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
144632|NCT00432159|Secondary|Subsequent Secondary Surgery Component of Success|no subsequent secondary surgical intervention at the index level|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
144633|NCT00432159|Secondary|Neurological Component of Success|no new clinically significant permanent abnormalities in neurological function|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
144634|NCT00432159|Secondary|NDI Success|15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.|24 months|Intent to Treat (As Randomized). The difference between the number of treated patients and the number of participants analyzed is due to: death of one randomized ACDF patient, patients who experienced a Device Failure before the 24 month visit, and patients with no data collected for this secondary outcome (missing data).||participants who are successes|||Number
144635|NCT00432159|Primary|Overall Success|Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.|24 months|The primary outcome was analyzed with an Intent to Treat (As Randomized) analysis. The difference between the number of treated patients and the number of participants analyzed for each group at the 24 month visit is due to: death of one randomized ACDF patient and patients with no data for NDI and Neurological function (missing data).||participants who are successes|||Number
144636|NCT00431964|Primary|Change in FEV1 From Baseline to End of Treatment at Day 168||change from baseline to day 168|Modified intent to treat (randomized and at least one dose of study drug).||liters||Standard Deviation|Mean
144637|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).||mg||Standard Deviation|Mean
144638|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)|Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||mg||Standard Deviation|Mean
144639|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).||ng*hr/mL||Standard Deviation|Mean
144640|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)||ng*hr/mL||Standard Deviation|Mean
144641|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||ng*hr/mL||Standard Deviation|Mean
144642|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 21|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group).||hours||Standard Deviation|Mean
144643|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)||hours||Standard Deviation|Mean
144644|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)||hours||Standard Deviation|Mean
144645|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||hours||Standard Deviation|Mean
144646|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 21|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. Between Days 6 and 21, there were 4 (out of 7 total) withdrawals due to inability to follow procedure (2; 250mg and placebo groups), lost to follow-up (1; 400mg group), and adverse event (1; 800mg group)||ng/mL||Standard Deviation|Mean
144647|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 6|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each and one placebo group with 6 subjects. By Day 6 there were 3 (out of 7 total) withdrawals from the study due to inability to follow procedure (2; 800mg and placebo groups), and requested due to concomitant medication (1; 400mg group)||ng/mL||Standard Deviation|Mean
144648|NCT00431951|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1|Post-screening, 30 healthy subjects were randomized on Day 1 into three active drug groups with 8 subjects each and one placebo group with 6 subjects||ng/mL||Standard Deviation|Mean
144649|NCT00431951|Primary|Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table|"Evaluated safety parameters included:~physical examination/vital signs~electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)~laboratory safety tests (hematology, chemistry, urinalysis)~adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in DAIDS AE Table)and ST-246-related, they were considered severe and significant, respectively."|Days 1, 6, 14-16, 21-24, 28-31, and 51-53|Post-screening, 30 healthy subjects were randomized into three active drug groups with 8 subjects each, and one placebo group with 6 subjects. A total of 7 withdrawals during the entire study were due to inability to follow procedure (4), lost to follow-up (1), requested due to concomitant medication (1), and an adverse event (1)||Participants|||Number
144650|NCT00431834|Primary|Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|30 days post procedure or hospital discharge|Entire study population.||Percentage of subjects||95% Confidence Interval|Number
144651|NCT00431834|Secondary|Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure|Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.|6 months|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.||percentage of subjects|||Number
144652|NCT00431834|Secondary|Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months||6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.||percentage of subjects|||Number
144653|NCT00431834|Primary|Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.|Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.|6 months|75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.||percentage of participants||95% Confidence Interval|Number
144654|NCT00431626|Primary|Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index|AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)|one year|||units on a scale||Standard Deviation|Mean
144655|NCT00431496|Secondary|Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL|The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
144656|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L|The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
144657|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L|The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
144658|NCT00431496|Secondary|Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)|The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
144659|NCT00431496|Secondary|Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL|Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
144660|NCT00431496|Primary|Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2|The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase.|Weeks 17 to 23|All participants who received cinacalcet||Participants|||Number
144661|NCT00431444|Secondary|Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens|At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: “once a year i.v. infusion,” “once daily pill,” or “both are equal.”|At 6 month visit|Intention-to-treat (ITT) population.||Participants|||Number
144662|NCT00431444|Secondary|Overall Patient Satisfaction Assessed by Satisfaction Questionnaire|Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.||Participants|||Number
144663|NCT00431444|Secondary|Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire|The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient’s i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.||Participants|||Number
144664|NCT00431444|Secondary|Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire|The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient’s i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: “not at all,” “a little,” “somewhat,” “quite,” or “completely.”|Immediately after infusion procedure|Intention-to-treat (ITT) population.||Participants|||Number
144665|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months||Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||U/L||Standard Deviation|Mean
144666|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months||Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||U/L||Standard Deviation|Mean
144667|NCT00431444|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months||Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||U/L||Standard Deviation|Mean
144668|NCT00431444|Secondary|Change From Baseline in Urine NTx at 4 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 4 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||nM BCE/mM Cr||Standard Deviation|Mean
144669|NCT00431444|Secondary|Change From Baseline in Urine NTx at 2 Months|The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 2 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||nM BCE/mM Cr||Standard Deviation|Mean
144670|NCT00431444|Primary|Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)|The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.|Baseline and 6 months|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.||nM BCE/mM Cr||Standard Deviation|Mean
144671|NCT00430950|Secondary|Number of Participants Achieving Blood Pressure Goal.||8 weeks|||participants|||Number
144672|NCT00430950|Secondary|Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.|Change = Week 16 - Week 8 (baseline).|8 weeks|Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP.||mm Hg||Standard Deviation|Mean
144673|NCT00430950|Secondary|Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.|4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).|8 weeks|||mm Hg||Standard Deviation|Mean
144674|NCT00430950|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12|Change = Week 12 - Week 8 (baseline).|4 weeks|||mm Hg||Standard Deviation|Mean
144675|NCT00430950|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure|"change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.~Change = Week 16 - Week 8 (baseline)."|8 weeks|The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres.||mm Hg||Standard Deviation|Mean
144676|NCT00430937|Secondary|Microbiological Efficacy Measured by the Number of Participants Achieving Bacteriological Eradication of Gram-positive Baseline Pathogens at the TOC Visit.|"Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated at the TOC evaluation and a superinfecting pathogen was not isolated either prior to or at the TOC evaluation.~Microbiological Failure: Persistence of one or more infecting Gram-positive pathogens or isolation of a superinfecting pathogen prior to or at the TOC evaluation."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|Population analyzed consisted of patients from the clinically evaluable population who had microbiological assessments.||Participants|||Number
144677|NCT00430937|Primary|"Clinical Success as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in the Clinically Evaluable Population."|"Success: Total resolution of clinically significant signs and symptoms of the infection site (cure) or improvement to such a level that no further antibacterial therapy was required (improvement).~Failure: Persistence or progression of signs and symptoms after at least 3 days of study therapy, or development of new signs and symptoms at the infection site, or concomitant or additional antibacterial therapy with documented activity against isolated organisms, or a treatment duration greater than 14 days, or requirement of a major surgical procedure as adjunct or follow-up therapy."|Baseline to TOC Visit (7-14 days after end of treatment) up to 4 weeks|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for cSSTI as listed in the Protocol, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.||Participants|||Number
144678|NCT00430781|Primary|Progression-free Survival (PFS) in Final Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||Weeks||90% Confidence Interval|Median
144679|NCT00430781|Secondary|Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib|Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data.|From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)|Safety Population: all participants who received at least one dose of study drug||participants|||Number
144691|NCT00430716|Secondary|Change From Baseline in Pro-BNP at Week 12|Pro- BNP which is a precursor of BNP, is a non-invasive biomarker and an indicator of progression of PAH / RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||pg/mL||95% Confidence Interval|Mean
144680|NCT00430781|Secondary|Duration of Response|For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population. The median for lapatinib was not reached at the time of data cut-off. No formal analysis of this endpoint was conducted for this group due to a very small number of responding participants.||weeks||90% Confidence Interval|Mean
144681|NCT00430781|Secondary|Time to Response|For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||weeks||90% Confidence Interval|Mean
144682|NCT00430781|Secondary|Response|Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||participants|||Number
144683|NCT00430781|Secondary|Clinical Benefit Response|Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments.|From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)|ITT Population||participants|||Number
144684|NCT00430781|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)|ITT Population||Weeks||90% Confidence Interval|Median
144685|NCT00430781|Primary|Progression-free Survival (PFS) in Interim Analysis|PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.|From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)|Intent to Treat (ITT) Population: all randomized participants||Weeks||90% Confidence Interval|Median
144686|NCT00430768|Secondary|hAAT Expression in Blood Measured Using M-specific Allele ELISA|4 subjects received prior AAT augmentation therapy; 2 subjects from Group 1 having only washed out for only 28 days complicated the measurement of M-specific levels 2 subjects from group 1 and the other subject did not have an appreciable change in M-specific AAT levels. Thus reporting only Cohorts 2 and 3. After day 90 patients were able to resume AAT protein therapy and thus levels were not collected following commencement of therapy on 201 and 303. 202, Day 365 blood hemolyzed; level not determinable.|Baseline, Days 14, 30, 45, 60, 90, (180, 270, and 365 if not on protein replacement therapy)|AAT Levels of each subject at various time points Baseline and Days following administration. 202 Day 365 blood hemolyzed; not determinable, 201 and 303 went back on AAT protein augmentation therapy after day 90, unable to collect M-specific levels on day 180, 270 and 303.||nM|||Number
144687|NCT00430768|Primary|Adverse Events Possibly, Probably or Definitely Related to Study Drug|"Adverse events considered possibly, probably or definitely related to study drug/study drug procedure Criteria to evaluate severity according to Attachment 2 of the Protocol~Mild toxicity, usually transient, requiring no special treatment and generally not interfering with usual daily activities~Moderate toxicity which may be ameliorated by simple therapeutic maneuvers, and impairs usual activities~Severe toxicity which requires therapeutic intervention and interrupts usual activities. Hospitalization may or may not be required~Life-threatening toxicity which requires hospitalization"|During 1 year after study agent administration|subjects in the group reporting the event||participants|||Number
144688|NCT00430755|Primary|Detection of Medical Problems (by Number of Problems Reported by Computer Assisted History, That Were Not Reported by Physician Taken History)|Data were extracted from hospital charts by to experienced physicians.; data from the computer histories were extracted by a senior physician, who tabulated comparisons between the 2 sets of records. We used the number of problems reported by Computer Assisted History that were not reported by Physician. Nurses at Robert Bosch Krankenhaus do not take medical histories in regard to allergies or adverse drug reactions. Pharmacists make no entries into charts and have no separate records of drug allergies or history of adverse drug reactions. Data on these issues either are obtained only by physician interview of the patient.|participants were followed for the duration of hospital stay, an average of 8 days|The rest did not end the history tool||medical problems|||Number
144689|NCT00430716|Secondary|Change From Baseline in BORG Dyspnoea Score at Week 12|BORG dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||Units on a scale||95% Confidence Interval|Mean
144690|NCT00430716|Secondary|Change From Baseline in TAPSE Measurement at Week 12|TAPSE was measured as the total displacement of the tricuspid annulus in cm from end diastole to end systole.TAPSE is an indicator of progression of PAH / RV dysfunction.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||cm||95% Confidence Interval|Mean
144692|NCT00430716|Secondary|Change From Baseline in BNP at Week 12|BNP is a non-invasive biomarker and an indicator of progression of PAH/ RV dysfunction in participants with PAH.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||pg/mL||95% Confidence Interval|Mean
144693|NCT00430716|Secondary|Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12|PAH Criteria for WHO Class: Class I (Participants without resulting limitation of physical activity);Class II (Participants with slight limitation of physical activity though comfortable at rest);Class III (Participants with marked limitation of physical activity,though comfortable at rest);Class IV(Participants with inability to carry out any physical activity without symptoms,manifest signs of right heart failure; dyspnoea and/or fatigue may even be present at rest; and discomfort is increased by any physical activity).|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||Participants|||Number
144694|NCT00430716|Secondary|Time to Clinical Worsening|Clinical worsening was defined as death; or lung transplantation; or hospitalization due to pulmonary hypertension; or initiation of prostacyclin therapy; or initiation of endothelin receptor antagonist therapy.|Baseline through Week 12|Due to very low number of events of clinical worsening reported, the statistical analysis was not conducted and hence data not reported.||Days||Standard Error|Mean
144695|NCT00430716|Secondary|Change From Baseline in mPAP at Week 12|mPAP was measured using a pressure transducer positioned at the mid-axillary line.|Baseline and Week 12|ITT population included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, LOCF method of imputation was used.||mmHg||95% Confidence Interval|Mean
144696|NCT00430716|Primary|Change From Baseline in the Total Distance Walked During 6MWT at Week 12|6 MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Baseline and Week 12|Intention to Treat (ITT population) included all participants who were randomized to study treatment and received at least 1 dose of study medication. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.||Meters||95% Confidence Interval|Mean
144697|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4.|From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
144698|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN if preRX>ULN, use >1.05*preRX or <LLN. Potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN. Chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRX<LLN, use <0.75*preRX or >ULN if preRX>ULN, use >1.25*preRX or <LLN. Glucose, serum (mg/dL): <65 mg/dL, or >220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX <LLN, use <0.8*preRX or >ULN if preRX>ULN, use >2.0*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX <LLN, use <0.75*preRX. Cholesterol, total (mg/dL): >2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
144699|NCT00430677|Secondary|Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX <LLN, use <0.5*preRX and <100,000/mm^3. Leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8* preRX or >ULN; if preRX>ULN, use >1.2*preRX or <LLN. Neutrophils + Bands (absolute) (*10^3 c/uL): If value <1.0*10^3 or if value >7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX.|From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
144700|NCT00430677|Secondary|Number of Participants Achieving Renal Response|Renal response=serum creatinine level ≤25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol.|At Day 365 (end of short-term period) and Day 645|All randomized participants who received treatment.||participants|||Number
144701|NCT00430677|Secondary|Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period|Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids|Day 365 to end of long-term extension period|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available.||Participants|||Number
144702|NCT00430677|Secondary|Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From start of study drug in long-term period (Day 365) to up to 56 days after the last dose of the long-term extension (LTE). Deaths in LTE reported to >56 days post last dose.|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
144703|NCT00430677|Secondary|Mean Change From Baseline in SLICC/ACR Damage Index|SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly.|Day 365 to termination of the long-term extension phase|All randomized participants who received treatment. Treated participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e, Change from baseline greater than or equal to 0). 99, 99 and 100 participants were treated respectively. Refer to outcome measure 11 for baseline values||Units on a scale||Standard Error|Mean
144704|NCT00430677|Secondary|Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis|Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or ≤25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria.|At Day 365 (end of Short-term Period) and Day 645|All participants who entered and received at least 1 dose of study medication during the long-term extension period||Participants|||Number
144705|NCT00430677|Secondary|Number of Participants Achieving Complete Response by ACCESS Definition|The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine ≤upper limit of normal as defined by the central laboratory or ≤125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day.|End of short-term period (Day 365) to termination of the long-term extension period|All participants who entered and received at least 1 dose of study medication during the long-term extension period||participants|||Number
144706|NCT00430677|Secondary|Change in Quantitative Immunoglobulin From Baseline During Short-term Period|"A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.~Please refer to Outcome 31 for the respective baseline values"|Day 365|All randomized participants who received treatment. n=Participants with both postbaseline and baseline measurements||mg/dL||Standard Deviation|Mean
144707|NCT00430677|Secondary|Baseline Quantitative Immunoglobulins During the Short-term Period|A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing.|Baseline (Day 1)|||mg/dL||Standard Error|Mean
144708|NCT00430677|Secondary|Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period|A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the ‘Ig and/or Junction (Jn) Region’ and (2) ‘CLTA4 and possibly Ig’. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T.|Day 169, Day 365|Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available. n= number of participants who are evaluated||Participants|||Number
144709|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Temperature||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||degree celcius||Standard Deviation|Mean
144710|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Heart Rate||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||beats per minute||Standard Deviation|Mean
144711|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||mm Hg||Standard Deviation|Mean
144712|NCT00430677|Secondary|Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)||0 - 12 Months|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.||mmHg||Standard Deviation|Mean
144888|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index for Age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose body mass index for age z-scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
144713|NCT00430677|Secondary|Participants With Marked Abnormalities Urinalysis During the Short-term Period|PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4).|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
144714|NCT00430677|Secondary|Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period|"ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.~Alkaline Phosphatase:>2x ULN; ↑Aspartate Aminotransferase: >3x ULN; ↑Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ↑Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ↑Blood Urea Nitrogen >2x PTV; ↑Creatinine >1.5x PTV."|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
144715|NCT00430677|Secondary|Participants With Marked Laboratory Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ↑Serum Sodium:>1.05x ULN;↓Serum Potassium:<0.9x LLN;↑Serum Potassium:>1.1x ULN;↓Total Calcium:<0.8X LLN;↑Total Calcium:>1.2x ULN; ↓Serum Glucose(SG):<65 mg/dL;↑SG:>220 mg/dL;↓Fasting SG:<0.8x LLN;↑Fasting SG:>1.5x ULN;↓Total Protein:<0.9x LLN;↓Albumin:<0.9x LLN;↑Total Cholesterol:>2x PTV;↑Triglycerides:>=2.5x ULN;↑Fasting Triglycerides:>=2x ULN|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
144716|NCT00430677|Secondary|Participants With Marked Hematology Abnormalities During the Short-term Period|LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(↓)Hemoglobin:>3g/dL decrease from PTV; ↓Hematocrit:<0.75xPTV;↓Erythrocyte count:<0.75xPTV; high(↑)Platelet count:>1.5xULN;↓Platelet count:<0.67xLLN;↓Leukocyte count:<0.75X LLN;↑Leukocyte count:>1.25xULN;↓Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;↑AB Lymphocyte count:>7.50x10^3 c/uL; ↓AB lymphocyte count:<0.750x10^3 c/uL;↑AB monocyte count:>2000/mm^3;↑AB basophil count:>400/mm^3;↑AB eosinophil count:>0.750x10^3 c/uL.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements||Participants|||Number
144717|NCT00430677|Secondary|Participants With AEs of Special Interest During the Short-term Period|AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.||Participants|||Number
144718|NCT00430677|Secondary|Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.|From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.|All participants who received at least one dose of double-blind study medication were included in the safety population.||Participants|||Number
144719|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population (all randomized and treated subjects). To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Least Squares Mean
144720|NCT00430677|Secondary|Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period|The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
144796|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV6 at Week 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
144721|NCT00430677|Secondary|Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period|"A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.~The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue."|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Mean
144722|NCT00430677|Secondary|Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period|A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
144723|NCT00430677|Secondary|Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward (LOCF), participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Mean
144724|NCT00430677|Secondary|Baseline Mental Component Summary of the Short SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
144725|NCT00430677|Secondary|Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.||Units on a scale||Standard Error|Mean
144726|NCT00430677|Secondary|Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), Days 85, 169, 253, and 365|n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||Units on a scale||Standard Deviation|Mean
144727|NCT00430677|Secondary|Change in SLICC/ACR Damage Index From Baseline During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value.|Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)|All randomized participants who received treatment and who had postbaseline and baseline measurements showing nonreversible changes (change from baseline >=0) in the SLICC-ACR Damage Index||Units on a scale||Standard Error|Mean
144810|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.|Baseline and Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.||percent change from baseline||Standard Deviation|Mean
144728|NCT00430677|Secondary|Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period|RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5.|Month 12|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants||95% Confidence Interval|Number
144729|NCT00430677|Other Pre-specified|Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period|"PR is either CRR, Partial Renal Response(PRR),or no Response(NR).~CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR."|Month 12|All randomized participants who received treatment.||Participants|||Number
144730|NCT00430677|Secondary|Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)|n=Participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e., Change from Baseline greater than or equal to 0).||Units on a scale||Standard Deviation|Mean
144731|NCT00430677|Secondary|Change in Renal Function From Baseline Over Time During Short-term Period|Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|ITT population (all randomized and treated subjects). n= Number of participants with both baseline and post-baseline measurements for that time point.||milliliters per minute (mL/min)/1.73 m^2||Standard Error|Mean
144732|NCT00430677|Secondary|Baseline Renal Function Over Time During Short-term Period|Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening.|Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|n= Number of participants with measurements for that time point. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.||milliliters per minute (mL/min)/1.73 m^2||Standard Deviation|Mean
144733|NCT00430677|Secondary|Number of Months CRR Was Maintained During Short-term Period|Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR.|Day 1 (randomization) to 12 Months|All randomized participants who received participants.||Months||Full Range|Median
144734|NCT00430677|Secondary|Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period|CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants||95% Confidence Interval|Number
144735|NCT00430677|Secondary|Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)|RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation||Days||95% Confidence Interval|Median
144811|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit|The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.||percentage of subjects|||Number
144736|NCT00430677|Secondary|Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|At Month 12 from Day 1|All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.||Participants|||Number
144737|NCT00430677|Secondary|Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 to 12 months|All randomized participants who received treatment. Participants who discontinued early without meeting the confirmed CRR criteria were imputed as nonresponders.||Participants|||Number
144738|NCT00430677|Primary|Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period|Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.|Day 1 (randomization) to 12 months.|All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation.||days|||Number
144739|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives||Baseline to 12 months|146 Stage 2 hypertensive participants from both the olmesartan and placebo groups||mm Hg||Standard Deviation|Least Squares Mean
144740|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives||Baseline to 12 weeks|130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.||mm Hg||Standard Deviation|Least Squares Mean
144741|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants.||Baseline to 12 weeks|221 non-Black participants from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
144742|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants.||Baseline to week 12|55 Black participants from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
144743|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old.||Baseline to 12 weeks|44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
144744|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old.||Baseline to 12 weeks|232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
144745|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females.|The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|145 female participants from both the olmesartan and placebo groups were analyzed.||mm Hg||Standard Deviation|Least Squares Mean
144746|NCT00430638|Secondary|The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males.|The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.|Baseline to week 12|131 male participants||mm Hg||Standard Error|Least Squares Mean
144747|NCT00430638|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed.||mm Hg||Standard Error|Least Squares Mean
144889|NCT00429364|Secondary|Annual Rate of Change in Body Mass Index||Up to 3 years following randomization.|All randomized participants whose body mass indexes were measured at baseline and at any of the follow-up visits.||kg/m^2 per year||Standard Error|Least Squares Mean
144748|NCT00430638|Primary|Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.|The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.|baseline to 12 weeks|The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.||mm Hg||Standard Error|Least Squares Mean
144749|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Chemokine (C-C Motif) Ligand 18 (CCL18)||Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed.||Percent|||Number
144750|NCT00430625|Secondary|Percent Change From Baseline to 12 Months in Plasma Chitotriosidase for Each Treatment Group|Percent Change from Baseline to Weeks 53 by Randomized velaglucerase alfa Treatment Group - Subset of intent to treat (ITT) Population who were wild type homozygous for chitotriosidase.|Week 53|2 patients in the 60 U/kg group and 7 patients in the 45 U/kg group who were wild type for the chitotriosidase mutation were analyzed; remaining patients were deficient in chitotriosidase activity.||Percent|||Number
144751|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Spleen Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI))|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population. Spleen Volume has been normalized for percent of body weight for each treatment arm. Spleen size relative to body weight = (Spleen volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||Percent body weight||95% Confidence Interval|Mean
144752|NCT00430625|Secondary|Change From Baseline to 12 Months in Normalized Liver Volume (Percent Body Weight) for Each Treatment Group (Measured by Magnetic Resonance Imaging (MRI)|Liver Volume has been normalized for percentage of body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cc]/Body weight [kg])*100|Week 51|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||Percent body weight||95% Confidence Interval|Mean
144753|NCT00430625|Secondary|Change From Baseline to 12 Months in Platelet Counts for Each Treatment Group.|intent to treat (ITT) Population|Week 53|12 patients in the 60 U/kg group and 13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||x10^9/L||95% Confidence Interval|Mean
144754|NCT00430625|Secondary|Change From Baseline to 12 Months in Hemoglobin Concentration in 45 U/kg Treatment Group||Week 53|13 patients in the 45 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||(g/dL)||95% Confidence Interval|Mean
144755|NCT00430625|Primary|Change From Baseline to 12 Months in Hemoglobin Concentration for the 60 U/kg Treatment Group.|Efficacy endpoint|Week 53|12 patients in the 60 U/kg group were analyzed for efficacy in the intent to treat (ITT) population.||g/dL||95% Confidence Interval|Mean
144756|NCT00430508|Secondary|Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases||mm Hg||Standard Deviation|Mean
144757|NCT00430508|Secondary|Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases||mm Hg||Standard Deviation|Mean
144758|NCT00430508|Secondary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Observed Cases||mm Hg||Standard Deviation|Mean
144759|NCT00430508|Secondary|Number of Patients Achieving Target Blood Pressure at Week 16|Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics|8 weeks|Full Analysis Set-Last Observation Carried Forward||participants|||Number
144760|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward||mm Hg||Standard Deviation|Mean
144761|NCT00430508|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.||mm Hg||Standard Deviation|Mean
144762|NCT00430508|Secondary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.|Change = Week 12 - Week 8 (baseline).|4 weeks, change = week 12 - week 8|Full Analysis Set-Last Observation Carried Forward||mm Hg||Standard Deviation|Mean
144763|NCT00430508|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16|Change = Week 16 - Week 8 (baseline).|8 weeks, change = week 16 - week 8|Full Analysis Set-Last Observation Carried Forward.||mm Hg||Standard Deviation|Mean
144764|NCT00430495|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 38|Safety population included all randomized participants who received at least 1 treatment dose and had safety data following their first dose.||participants|||Number
144765|NCT00430495|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26|"The EULAR response criteria evaluate change in DAS28 scores represented as good response, moderate response, or no response considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have good or moderate EULAR response if at the time of assessment, their DAS28 score was <=5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2."|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
144766|NCT00430495|Secondary|Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Percentage of participants achieving improvement in HAQ-DI of at least 0.3 from baseline at Week 26 was reported.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||percentage of participants|||Number
144767|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
144768|NCT00430495|Secondary|Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26|DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100-millimeter (mm) visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
144769|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26|ACR70-CRP response is defined as >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
144770|NCT00430495|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26|ACR50-CRP response is defined as >=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
144771|NCT00430495|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26|ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP).|Week 26|ITT population included all randomized participants who received at least 1 treatment dose.||percentage of participants|||Number
144772|NCT00430352|Secondary|Percentage of Participants With PR Who Converted to CRu|Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants with PR to most recent treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
144773|NCT00430352|Secondary|Percentage of Participants With Response by Best Response to Study Treatment|Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population; only participants who received any study treatment were included in the analysis.||percentage of participants|||Number
144774|NCT00430352|Secondary|Time to NLT - Time to Event|TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||months||95% Confidence Interval|Median
144812|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percentage of subjects|||Number
149293|NCT00394654|Secondary|Time to Observed Maximum Sputum Concentration (Tmax)|Tmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
144775|NCT00430352|Secondary|Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event|As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
144776|NCT00430352|Secondary|Overall Survival (OS) - Time to Event|OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants||95% Confidence Interval|Median
144777|NCT00430352|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
144778|NCT00430352|Secondary|Event-Free Survival (EFS) - Time to Event|EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||months||95% Confidence Interval|Median
144779|NCT00430352|Secondary|Event-Free Survival (EFS) - Percentage of Participants With an Event|The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
144780|NCT00430352|Secondary|Progression-Free Survival - Time to Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||months||95% Confidence Interval|Median
144781|NCT00430352|Secondary|Progression-Free Survival - Percentage of Participants With an Event|PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.|Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose|ITT population||percentage of participants|||Number
144782|NCT00430352|Primary|Percentage of Participants With an Adverse Event (AE) - Overall Summary|Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.|24 months|Safety Population: any participant who received at least 1 dose of study treatment.||percentage of participants|||Number
144783|NCT00430300|Other Pre-specified|Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6|Data for this pre-specified endpoint was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
144784|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||bpm||Standard Deviation|Mean
144785|NCT00430300|Other Pre-specified|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8|Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia’s formula (QTcF=QT divided by cube root of RR Int) and Bazett’s formula (QTcB=QT divided by square root of RR Int).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||milliseconds (msec)||Standard Deviation|Mean
144786|NCT00430300|Other Pre-specified|Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
144787|NCT00430300|Other Pre-specified|Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6|Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).|Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.||bpm||Standard Deviation|Mean
144788|NCT00430300|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
144789|NCT00430300|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)|CGI-C: clinician’s global impression of a participant’s clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||participants|||Number
144790|NCT00430300|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant’s daily values were averaged over each week.|Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter per minute||Standard Deviation|Mean
144791|NCT00430300|Secondary|Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8|Participants were issued with rescue medication (Salbutamol MDI [100 mcg/actuation]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant’s daily use (puffs/day) was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||puffs/day||Standard Deviation|Mean
144792|NCT00430300|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8|COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant’s daily score for each symptom was averaged over each week.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||units on a scale||Standard Deviation|Mean
144793|NCT00430300|Secondary|Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6|BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.|Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||units on a scale||Standard Deviation|Mean
144794|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator IC at Week 6|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
144795|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FVC at Week 6|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
144797|NCT00430300|Secondary|Change From Baseline in Post-Bronchodilator FEV1 at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.|15 to 30 minutes post-bronchodilator administration at Baseline, Week 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘N’(number of participants analyzed) signifies participants who were evaluable for this measure.||liter||Standard Deviation|Mean
144798|NCT00430300|Secondary|Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6|IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
144799|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
144800|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.|||||
144801|NCT00430300|Secondary|Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.|15 to 30 minutes post-dose at Baseline, Week 2, 4, 6|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
144802|NCT00430300|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8|IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
144803|NCT00430300|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
144804|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 6, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
144805|NCT00430300|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 2, 4, 8|FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
144806|NCT00430300|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Pre-dose at Baseline, Week 6|Full analysis set (FAS): all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Missing data were imputed using Last Observation Carried Forward (LOCF). Here ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.||liter||Standard Deviation|Mean
144807|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.|The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.||percent change from baseline||Standard Deviation|Mean
144808|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percent change from baseline||Standard Deviation|Mean
144809|NCT00430248|Secondary|Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit|Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.|Baseline and Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percent change from baseline||Standard Deviation|Mean
144815|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with a post-baseline serum urate value.||percentage of subjects|||Number
144816|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percentage of subjects|||Number
144817|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percentage of subjects|||Number
144818|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit||percentage of subjects|||Number
144819|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Analysis was performed on the ITT subjects with a serum urate value at Month 6 visit.||percentage of participants|||Number
144820|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.|Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.|Month 4|Analysis was performed on the ITT subjects with a serum urate value at Month 4 visit.||percentage of subjects|||Number
144821|NCT00430248|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.|Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.|Month 2|Analysis was performed on the ITT subjects with a serum urate value at Month 2 visit.||percentage of subjects|||Number
144822|NCT00430248|Secondary|Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl|The percentage of subjects with mild-to-moderate renal impairment whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on the ITT subjects with mild-to-moderate renal impairment (estimated creatinine clearance of 30 mL/min to 89 mL/min), with a post-baseline serum urate level.||percentage of subjects|||Number
144823|NCT00430248|Primary|Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.|The percentage of subjects whose serum urate level was <6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 6 months)|Analysis was performed on intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. A subject's baseline value was used in the primary analysis if no postbaseline serum urate level was obtained.||percentage of subjects|||Number
144824|NCT00430092|Primary|Anterior Chamber Cell Grade of “0” on Day 8 (Difluprednate QID vs Placebo).|Measured on a 0 to 4 scale: “0” is ≤ 1 cell; “1” is 2-10 cells; “2” is 11-20 cells; “3” is 21-50 cells; “4” is > 50 cells.|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.||participants|||Number
144825|NCT00430027|Primary|Overall Toxicity|The primary objective of this pilot study was to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab is feasible with acceptable toxicity profile.|Up to 4 weeks|The study was terminated, study end points were not reached.|||||
144826|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Relapsed Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)|||days||95% Confidence Interval|Median
144827|NCT00429949|Secondary|Event-free Survival (EFS) for Participants With Plateau Phase Disease|EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.|Completion of treatment (median duration of therapy was 51 days)|||days||95% Confidence Interval|Median
144828|NCT00429949|Secondary|Duration of Response|Duration of response is measured from the first date that criteria are met for complete response or partial response until the first date that criteria for relapse or progressive disease are met.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.||cycles|||Number
144829|NCT00429949|Secondary|Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)|Toxicities were graded using the NCI Common Toxicity Criteria v3.0.|Up to 30 days following end of treatment (median duration of therapy was 51 days)|||participants|||Number
144830|NCT00429949|Secondary|Time to Response|Time to response is measured from the start of treatment until the first date that criteria are met for complete response or partial response.|Completion of treatment (median duration of therapy was 51 days)|Only one patient achieved a partial response.||cycles|||Number
144831|NCT00429949|Primary|Response Rate [Complete Response (CR) and Partial Response (PR)]|"CR requires all of the following:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR.~< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow.~No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response).~Disappearance of soft tissue plasmacytoma~PR requires all of the following:~50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks.~-Reduction in 24 hr urinary light chain excretion by either > 90% or to < 200 mg, maintained for a minimum of 6 weeks.~50% reduction in the size of soft tissue plas"|Completion of treatment (median duration of therapy was 51 days)|||participants|||Number
144832|NCT00429923|Primary|"Anterior Chamber Cell Grade of 0 on Day 8 (Difluprednate QID vs Placebo)."|Measured on a 0 to 4 scale: “0” is ≤ 1 cell; “1” is 2-10 cells; “2” is 11-20 cells; “3” is 21-50 cells; “4” is > 50 cells.|Day 8 (QID)|The ITT population was defined as all randomized subjects who received at least 1 administration of the study drug. Analysis of the ITT population, with LOCF for missing data, was conducted for all primary and secondary endpoints at Days 3, 8, 15, and 29.||participants|||Number
144833|NCT00428844|Secondary|Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.||µg•hr/mL||Full Range|Median
144834|NCT00428844|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)|The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.|Day 4 (steady state)|Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.||µg/mL||Full Range|Median
144835|NCT00428844|Secondary|Microbiological Response|Sponsor’s assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent to Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.||Participants|||Number
144836|NCT00428844|Secondary|Overall Clinical Outcome|The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.|Approximately 6 weeks post last dose (approximately week 12)|Modified Intent-to-Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.||Participants|||Number
144837|NCT00428844|Secondary|Safety - Notable Laboratory Abnormalities|Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.|From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)|Safety Population||Participants|||Number
144838|NCT00428844|Primary|Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)|Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.|From the 3rd day of therapy to 1 week post last dose (approximately week 7)|Safety Population||Participants|||Number
144839|NCT00428792|Secondary|Clinical Global Impression (CGI-I) Scale Score – Physician Rating of Improvement (Change in State)|The CGI-I is a scale to assess improvement (change in state) of illness. The rating is based on the investigator answering one question: “Compared to the patient’s condition prior to medication, this patient’s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.” The investigator compares the patient’s overall clinical condition to the 1 week period just prior to the initiation of medication.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Units on a scale||Standard Deviation|Mean
144840|NCT00428792|Secondary|Clinical Global Impression Severity (CGI-S) Scale Score – Physician Rating of Severity|The CGI-S is a scale to assess the global severity of illness. The rating is determined by the investigator answering one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Ratings are on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The rating is based upon the average observed and reported symptoms, behavior, and function in the past 7 days.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
144890|NCT00429364|Secondary|Annual Rate of Change in Height-for-age Z-score||Up to 3 years following randomization.|All randomized participants who were between 0-20 years of age and whose heights were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
144891|NCT00429364|Secondary|Annual Rate of Change in Height||Up to 3 years following randomization.|All randomized participants whose heights were measured at baseline and at any of the follow-up visits.||cm/year||Standard Error|Least Squares Mean
144841|NCT00428792|Secondary|10-Minute Math Test – Problems Solved|The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Problems solved||Standard Deviation|Mean
144842|NCT00428792|Secondary|10-Minute Math Test – Problems Attempted|The 10-Minute Math Test is a paper and pencil test consisting of several pages of math problems requiring addition, subtraction, multiplication and division calculations presented in ascending order of difficulty during a 10-minute period. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted is an objective measure related to “academic productivity”. The math test was carried out on the Saturday visit at the end of each of the 2 treatment weeks under supervision of a teacher who had been trained on this test.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population includes all randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.||Problems attempted||Standard Deviation|Mean
144843|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Per protocol (PP) population: All patients in the ITT population who (a) met the inclusion/exclusion criteria liable to affect the efficacy assessment and (b) did not violate the protocol in a manner liable to affect the efficacy assessment.||Units on a scale||Standard Deviation|Mean
144844|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Saturday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
144845|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (4 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 4) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
144846|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating|Teacher rating of the hyperactivity subscale (7 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 7) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
144847|NCT00428792|Secondary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating|Teacher rating of the attention deficit subscale (9 items), one of 3 subscales in the FBB-ADHS. Each item is rated on a scale of 0 = not at all up to 3 = very much. The rating was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 9) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
144848|NCT00428792|Primary|Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population|The FBB-ADHS is a 20-item rating scale. Each item describes a typical ADHD symptom. The 20 items are divided into 3 subscales: Attention deficits (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item is rated on a scale of 0 = not at all up to 3 = very much. The FBB-ADHS was completed by teachers on Friday afternoon of each week of the study. A total score (sum of all items divided by 20) was calculated. The total score can range from 0 to 3. A lower score indicates more ADHD.|Friday of each of the 2 treatment weeks|Intent to treat (ITT) population: All randomized patients with at least one post-baseline measurement of the primary endpoint in both study periods.||Units on a scale||Standard Deviation|Mean
144849|NCT00429793|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry|Study entry up to 2 years|||participants|||Number
144850|NCT00429793|Other Pre-specified|Reason Off Study Therapy||from study entry until end of study treatment|||participants|||Number
144851|NCT00429793|Secondary|Duration of Overall Survival|Characterized with Kaplan-Meier plots and estimates of the median time until death or progression.|Up to 5 years||||||
144852|NCT00429793|Secondary|Duration of PFS|Characterized with Kaplan-Meier plots and estimates of the median time until death or progression.|Up to 6 months||||||
144854|NCT00429793|Primary|Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.|Up to 5 years|||participants|||Number
144855|NCT00429793|Primary|6 Month Progression-free Survival (PFS)|Number of participants who survived progression-free for more than 6 months.|6 months|||participants|||Number
144856|NCT00429702|Secondary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis After Completion of the First Course of Emetogenic Chemotherapy|CINV will be determined based on the number of rescue medications used during the 3 days following completion of chemotherapy cycle. Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy – it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient’s symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|3 days of following completion of first chemotherapy cycle|||participants|||Number
144857|NCT00429702|Primary|Proportion of Patients Requiring Rescue Medication for Breakthrough Nausea or Emesis During Inpatient Chemotherapy|Rescue medication is any medication administered by the treating team to control breakthrough nausea or emesis. Rescue medications were used to treat any patient who has enough symptoms requiring additional therapy. All patients were instructed to first use the push button on the pump. On-demand administration of study agent via the patient-controlled infusion pump will not be considered rescue therapy – it is part of the antiemetic treatment regimen. If on-demand administration is not successful in controlling the patient’s symptoms, then as-needed rescue medications are to be administered. The treating staff will administer additional (as needed) doses of intravenous antiemetics, depending on the institutional preference.|during in-patient cycle of chemotherapy, up to 4 days|||participants|||Number
144858|NCT00429663|Secondary|Valgus of Over 5 Degrees||12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered the flow.||participants|||Number
144859|NCT00429663|Primary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered the flow.||units on a scale||Standard Deviation|Mean
144860|NCT00429663|Primary|EQ Index|EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered the flow.||units on a scale||Standard Deviation|Mean
144861|NCT00429663|Primary|Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered the flow.||units on a scale||Standard Deviation|Mean
144862|NCT00429663|Primary|EQ-5D|EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.|3 months, 6 months, 12 months|160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered the flow.||units on a scale||Standard Deviation|Mean
144863|NCT00429572|Primary|Number of Participants With Acute or Chronic GVHD And Response to Therapy|"Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from Consensus conference on acute GVHD grading, Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy."|Transplant to 1 year post transplant|As treated: Eighteen received the allogeneic transplantation.||participants|||Number
144864|NCT00429572|Primary|Grade II-IV Toxicity|Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe).|Up to one year.|As treated: Eighteen received the allogeneic transplantation.||Participants|||Number
144865|NCT00429572|Primary|Time to Progressive Disease|Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first.|Transplant to Progression.|||Days||Full Range|Median
144866|NCT00429572|Primary|Overall Survival|Survival duration was calculated from time of transplantation by number of days.|Transplant until death.|As treated: Eighteen received the allogeneic transplantation.||Days||Full Range|Median
144892|NCT00429364|Secondary|Annual Rate of Change in Weight-for-height Z-score||Up to 3 years following randomization.|All randomized participants who were <120 cm in heights and whose weight-for-height z-scores were measured at baseline or at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
144867|NCT00429572|Primary|Number of Participants With Tumor Response|Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.|Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.|As treated: Eighteen received the allogeneic transplantation.||participants|||Number
144868|NCT00429507|Primary|Time to Progression|Time to progression is measured as the time from study entry to the development of disease progression.|7.5 Years, Study period was March 2007 to November 2014.|||Days||Full Range|Median
144869|NCT00429494|Primary|Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide|Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.|6 months|Of the 59 patients who underwent HSCT, nine patients refused the second dose of leuprolide and were subsequently taken off study. Six patients died of either disease progression or transplantation-related complications before their ovarian function status was evaluated.||participants|||Number
144870|NCT00429416|Secondary|Number of Patients Who Achieve a CD4 Count > 200/Micro-liters|Determine the number of patients who achieve a CD4 count > 200/micro-liters by 60 days after transplant.|Through 60 Days Post Transplant|||participants|||Number
144871|NCT00429416|Secondary|Rate of Serious Infectious Complications|"Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy.~CD4 counts will be measured monthly for the first 3 months after transplant."|Through 3 months post-transplant|||participants|||Number
144872|NCT00429416|Secondary|Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)|Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit.|Through 24 months post-treatment|||participants|||Number
144873|NCT00429416|Secondary|Rate of Engraftment of Non-Myeloablative Transplants|Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products.|Through 30 days post-transplant|||participants|||Number
144874|NCT00429416|Primary|Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality|"Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events.~This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included."|Through 100 days post-transplant or death|||participants|||Number
144875|NCT00429403|Primary|Number of Patients With Response (FSH Level + Vaginal Bleeding)|Outcome characterized in terms of two variables, each measured repeatedly over time: Follicle-stimulating hormone (FSH) level and whether vaginal bleeding occurs, each to be measured from the end of chemotherapy. For treatment comparison, “response” defined as a composite event: both [FSH < 15] and vaginal bleeding observed within 12 months after the end of chemotherapy, with both FSH and vaginal bleeding baseline observed before start of chemotherapy.|Baseline prior to chemotherapy then every 3 months after chemotherapy for 1 year|Analysis was per protocol. Limited analysis due to low recruitment and early termination.||participants|||Number
144876|NCT00429364|Secondary|Adverse Drug Reactions Reported During Routine Follow-up Surveillance||From 6 months to 3 years following randomization.|All subjects who had any of the follow-up visits after 6 months post-randomization.||participants|||Number
144877|NCT00429364|Secondary|Adverse Drug Reactions Reported at the Baseline Visit||At baseline|All randomized participants.||participants|||Number
144878|NCT00429364|Secondary|Event Rate of the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.|Percentage of participants who had aortic dissection, aortic-root surgery or death over a 3-year period following randomization|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
144879|NCT00429364|Secondary|Number of Participants With the Composite Adverse Clinical Outcomes, Including Aortic Dissection, Aortic-root Surgery and Death.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
144880|NCT00429364|Secondary|Event Rate of Death|Percentage of participants who died over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
144881|NCT00429364|Secondary|Number of Death.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
144882|NCT00429364|Secondary|Event Rate of Aortic-Root Surgery|Percentage of participants who had aortic-root surgery over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
144883|NCT00429364|Secondary|Number of Participants With Aortic-root Surgery.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
144884|NCT00429364|Secondary|Event Rate of Aortic Dissection.|Percentage of participants who had aortic dissection over a 3-year period following randomization.|Up to 3 years following randomization.|All randomized participants who received the treatment||Percentage of participants||95% Confidence Interval|Number
144885|NCT00429364|Secondary|Number of Participants With Aortic Dissection.||Up to 3 years following randomization.|All randomized participants who received the treatment||participants|||Number
144886|NCT00429364|Secondary|Annual Rate of Change in Upper to Lower Segment Ratio||Up to 3 years following randomization.|All randomized participants whose upper to lower segment ratios were measured at baseline and at any of the follow-up visits.||1/year||Standard Error|Least Squares Mean
144895|NCT00429364|Secondary|Annual Rate of Change in Total Aortic Proximal Regurgitant Jet Area Indexed to Body-surface-area||Up to 3 years following randomization.|All randomized participants whose total aortic proximal regurgitant jet area indexes were measured at baseline or at any of the follow-up visits.||(mm^2/m^2)/year||Standard Error|Least Squares Mean
144896|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Aortic Annulus||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the aortic annulus were measured at baseline and at any of the follow-up visits.||cm/year||Standard Error|Least Squares Mean
144897|NCT00429364|Secondary|Annual Rate of Change in Aortic-annulus-diameter Z Score, Adjusted by Body-surface Area||Up to 3 years following randomization.|All randomized participants whose aortic-annulus-diameter z scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
144898|NCT00429364|Secondary|Annual Rate of Change in the Absolute Diameter of the Ascending Aorta||Up to 3 years following randomization.|All randomized participants whose absolute dimensions of the ascending aorta were measured at baseline and at any of the follow-up visits.||cm/year||Standard Error|Least Squares Mean
144899|NCT00429364|Secondary|Annual Rate of Change in Ascending-aorta-diameter Z Score, Adjusted by Body-surface-area.||Up to 3 years following randomization.|All randomized participants whose ascending-aorta-diameter z scores were measured at baseline and at any of the follow-up visits.||z-score/year||Standard Error|Least Squares Mean
144900|NCT00429364|Secondary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Absolute Dimension|The rate of change in the absolute dimension of the aortic root over a 3-year period following randomization|Up to 3 years following randomization.|||cm/year||Standard Error|Least Squares Mean
144901|NCT00429364|Primary|Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score|The rate of aortic root enlargement, expressed as the annual change in the maximum aortic-root-diameter z score indexed to body-surface area over a 3-year period following randomization|Up to 3 years following randomization.|||z-score/year||Standard Error|Least Squares Mean
144902|NCT00429299|Secondary|Number of Variations/Somatic Mutation in PI3KCA at Baseline|Analysis of mutations in the PI3KCA gene was performed from RNA extracted from frozen tumor tissue samples (sections). A gene is either a wild-type (no mutation) or mutated (presence of a mutation). Exons 9 and 20 of the PI3KCA gene were accessed (high frequency mutation at these two spots).|Baseline|ITT Population. Only those participants for which high-quality tumor tissue samples were available were analyzed.||Variations/Somatic mutations|||Number
144903|NCT00429299|Secondary|Number of Participants With Any Adverse Event (AE), Including Serious Adverse Events (SAEs), Occurring in >=5% of Participants|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment had been exercised in deciding whether reporting was appropriate in other situations.|From the first dose of randomized therapy to 30 days after the last dose of randomized therapy (assessed up to Study Week 29)|Safety Population: all randomized participants||Participants|||Number
144904|NCT00429299|Secondary|Percentage of Inhibition of Biomarkers Ki67, pAKT, pMAPK, Tunel Test, PTEN, and pEGFR After Treatment|The percentage of inhibition of intermediate (EGFR, HER2, pMAPK, pAKT, PTEN, and PI3KCA) and final (TUNEL and Ki67) biomarkers of the proliferation and apoptosis pathways was calculated as the difference between the staining scores before (Baseline [biopsy]) and after treatment (withdrawal).|At Baseline and Withdrawal (assessed up to Study Week 29)|ITT Population. Only those participants contributing data to the indicated time points were analyzed.||Percentage of inhibition||Full Range|Median
144905|NCT00429299|Secondary|Number of Participants With Treatment Failure|Treatment failure is defined as the occurrence of local tumor progression (including ipsilateral and controlateral breast), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional arm), or death due to any cause.|From randomization up to 29 weeks|ITT Population||Participants|||Number
144906|NCT00429299|Secondary|Time to Treatment Failure From the Start of Primary Therapy|Time to treatment failure (TTF) is defined as the interval of time between the date of randomization and the earliest date of disease progression, premature treatment discontinuation and death due to any cause. The overall disease progression date is the earlier of the two disease progression dates from ultrasonography and mammography assessments. For ultrasonography, disease progression is defined as at least 20% increase in the longest diameter of the primary lesion at pre-surgery comparing to Baseline. For mammography, disease progression is defined as at least 20% increase in the larger nodule dimension at pre-surgery comparing to Baseline. For participants who has neither progressed, pre-maturely withdrawn or died, time to treatment failure will be censored at the latest date of ultrasonography and mammography tumor assessments.|From randomization up to Study Week 307|ITT Population: all participants who were randomized||Months||95% Confidence Interval|Median
144907|NCT00429299|Secondary|Percentage of Participants Who Had Breast-conserving Surgery (BCS), Mastectomy, and Conversion From Mastectomy to BCS|The percentage of participants who had BCS and mastectomy and who were initiallycandidates for mastectomy and who actually had BCS was measured. At Baseline, the surgeon stated, within 4 weeks before starting the primary treatment, which type of surgical treatment he would perform in the absence of primary therapy and in the case of primary therapy (if the tumor size was reduced by the primary treatment to less than 3 centimeters), and the reasons for these choices. The rules for choosing the type of surgical treatment are reported in the Consensus Conference on Primary Treatment of Early Breast Cancer. The surgeon was to have re-evaluated the participant after primary treatment. In cases in which the type of surgical procedure was different from that originally programmed, the reason for this chance was to have been reported.|At Baseline and at surgery (up to Study Week 29)|Efficacy Analysis Population||Percentage of participants|||Number
144922|NCT00429104|Primary|Number of Participants With Tumor Response (Stable Disease)|Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.|2 months|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.||participants|||Number
149294|NCT00394654|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
144908|NCT00429299|Secondary|Percentage of Participants With the Indicated Clinical Objective Response (Complete Response and Partial Response), Stable Disease, and Progressive Disease, as Assessed by Ultrasonography|The clinical response was evaluated by comparing the tumor size (largest tumor diameter) before (at Baseline [biopsy]) and after treatment (before surgery), as assessed by ultrasonography examination. The clinical response was scored by Response Evaluation Criteria in Solid Tumors (RECIST) as follows: complete clinical response: the nodule is not detectable and all the ultrasound abnormality detected at diagnosis disappeared (margins circumscribed, round oval shape, parallel orientation, isoechoic echo pattern, no posterior acoustic features, echogenic lesion boundary, and tumor vascularity not present); partial clinical response: the longest diameter of the tumor has been reduced by >50%, and the ultrasound characteristics of the tumor persist; no response (stable disease): the longest diameter of the tumor has been reduced by <50% or has increased by no more than 20% from the starting value; progressive disease: tumor longest diameter has increased >20% from the starting value.|At Baseline and after primary treatment (within 2 weeks before surgery; up to Study Week 27)|Efficacy Analysis Population||Percentage of participants|||Number
144909|NCT00429299|Primary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and in the Lymph Nodes|Pathological Complete Response (pCR) is defined by the complete absence of infiltrating tumor cells in the breast and in the lymph nodes. The pathological response in the breast was evaluated according to the criteria of Miller and Payne as follows: Grade 1, no change or some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, a minor loss in tumor cells (up to 30%); Grade 3, between an estimated 30% and 90% reduction in tumor cells; Grade 4, marked disappearance of tumor cells, with only a small cluster or a dispersed cell remaining (more than 90% loss); Grade 5, no identifiable malignant cells. Ductal carcinoma in situ (DCIS) may be present. Grades were interpreted as follows: Grade 1-2=no response; Grade 3-4=partial response; Grade 5=complete response. pCR was defined by comparing specimens obtained at Baseline (biopsy) to those obtained upon surgery.|At Baseline and surgery (within 5 weeks after the last chemotherapy administration) (assessed up to Study Week 29)|Efficacy Analysis Population: all participants in the Intent-to-Treat Population (all participants who were randomized), except for the 2 participants who were excluded because of withdraw of consent and major protocol deviation||Percentage of participants|||Number
144910|NCT00429182|Secondary|Median Progression Free Survival (PFS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.|Overall study (baseline to disease progression)|Six participants were not evaluable for outcome assessment.||months||Full Range|Median
144911|NCT00429182|Primary|Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products|Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.|Baseline to 1 month post AHST|Twenty-one participants provided blood samples for the enumeration of CTCs, before apheresis (baseline) and at one month after AHST.||participants|||Number
144912|NCT00429169|Secondary|Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.|Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion.|Baseline and Week 8.||||||
144913|NCT00429169|Primary|Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment|Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.|Measured at Month 6|These were the number of subjects with analyzable data.||Events|||Number
144914|NCT00429169|Primary|Scale for Suicidal Ideation|The clinician-rated Beck Scale for Suicidal Ideation (SSI) (Beck et al 1979)was used weekly for 8 weeks. It has 19 items scaled 0 (least severe) to 2 (most severe) and total score is the sum, ranging 0 to 38 (Beck et al 1979). Items measure frequency, intensity, and attitudes toward suicidal thoughts, feelings of control over them, and suicide plans. Mean score in 90 inpatients hospitalized for suicidal ideation was 9.4±8.4, versus 4.4±5.8 in outpatients as cited in the study by Beck et al, 1979.|Baseline and Week 8|The study was powered for N=50 subjects per group based on naturalistic pilot data from our clinic. An interim data analysis showed an interaction of treatment with baseline suicidal ideation severity on follow-up ideation. After consulting with clinical colleagues, statisticians and the IRB, a decision was made to stop enrollment.||Points on Scale for Suicidal Ideation||Standard Deviation|Mean
144915|NCT00429169|Primary|Go-No go Test|Change in neuropsychological measure of impulsivity. Computer-based task involving induction of a dominant response tendency and testing of the subject's ability to withhold responding to less frequent non-target stimuli.|Measured at Baseline and Week 8|These were the number with analyzable data||Commission errors||Standard Deviation|Mean
144916|NCT00429143|Secondary|Incidence of Grades III-IV GVHD|"To determine the incidence and severity of GVHD in these patients using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.'~Severity was graded using CTCAE 3.0 (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death)"|6 months|Two patients died prior to expected engraftment. Two patients who rejected were retransplanted and were evaluable for GVHD.||participants|||Number
144917|NCT00429143|Secondary|Lymphoid Recovery|To assess the pace of lymphoid recovery in this patient population.|6 months|Two patients did not engraft, two patients died prior to expected day of engraftment||participants|||Number
144918|NCT00429143|Secondary|Engraftment Rates|To assess hematopoietic engraftment rates.|6 months|Two patients died prior to expected engraftment day||participants|||Number
144919|NCT00429143|Primary|Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD|"To determine the optimal dose of CD3+ donor lymphocytes required for consistent engraftment without the development of grade III/IV GVHD.~Measured as CD3+ donor lymphocytes given as n x 10^8/kg.~n was found to be 2 and was found to be the optimal dose and was the only dose given."|6 months|Two patients died prior to expected day of engraftment||lymphocytes x 10^8/kg|||Number
144920|NCT00429143|Primary|Overall Survival of Participants|To determine overall survival at 6 months post-transplant.|6 months|27 Patients undergoing haploidentical transplant at Thomas Jefferson University||participants|||Number
144921|NCT00429104|Secondary|Duration of Stable Disease|Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met.|6 Years|Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.||weeks||Full Range|Median
144923|NCT00429026|Primary|Survival Rate|Number of participants surviving at 4 years compared to total participants, to compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. Evaulation after 1, 2, 3, 6, 9, & 12 months, then every 4 months for 4 years.|Up to 4 years|Primary outcome measure was not assessed due to early study termination, e.g. patients did not receive assigned treatment.|||||
144924|NCT00428974|Secondary|Relationship Between Peripheral Blood Mononuclear Cell Adenosine A3 Receptor (A3AR) Expression Level at Baseline and Response to Therapy.|A3AR is measured biochemically and the expression level on cells from patients with disease is compared to that from healthy volunteer levels and expressed as a ratio|12 weeks||||||
144925|NCT00428974|Secondary|Individual PASI Components Redness, Thickness, and Scale|Each component is scored as 0 (clear, no disease) to 24 (most severe score); lower scores indicate improvement|12 weeks||||||
144926|NCT00428974|Secondary|"The Number of Patients Who Achieve a Score of Almost Clear or Clear by Physician's Global Assessment (PGA)"|PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome|12 weeks|||Number of treated patients|||Number
144927|NCT00428974|Primary|Frequency and Nature of Adverse Events||12 weeks||||||
144928|NCT00428974|Primary|Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score|PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement|12 weeks minus baseline|||Scores on a scale||Standard Deviation|Mean
144929|NCT00428922|Secondary|Changes in CECs as Predictors of PFS and Clinical Benefit|Circulating endothelial cells (CECs) are to be collected day 1 prior to treatment and day 22 prior to treatment. These samples are to be collected at the PI‘s discretion based upon the availability of the cell processing laboratory, the patients will be informed when consented if the samples will collected or not.|Day 1 and Day 22|CEC data was not collected and available for analysis|||||
144930|NCT00428922|Secondary|Overall Clinical Benefit Rate (CR+PR+SD)|Defined as best response of CR or PR or stable disease for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|at least 24 weeks|||percent of patients||95% Confidence Interval|Number
144931|NCT00428922|Secondary|Changes in CTCs as Predictors of PFS and Clinical Benefit|Circulating tumor cells (CTCs) evaluated at baseline (day 1 of treatment) and after 1 treatment cycle (day 22 prior to cycle 2 treatment).|Day 1 and Day 22|Due to sample size, could not perform any statistical analysis to correlate the baseline CTCs with PFS and response rate. Samples only available for 50% of the patients.||patients with detected CTCs|||Number
144932|NCT00428922|Primary|Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.|The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.|up to 3 years|||months||95% Confidence Interval|Median
144933|NCT00428597|Secondary|EORTC QLQ-C30 - Pain Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144934|NCT00428597|Secondary|EORTC QLQ-C30 - Nausea and Vomiting Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144935|NCT00428597|Secondary|EORTC QLQ-C30 - Insomnia Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144956|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection||Pre-injection and 10 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||Millimeters||Full Range|Mean
144936|NCT00428597|Secondary|EORTC QLQ-C30 - Financial Difficulties Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144937|NCT00428597|Secondary|EORTC QLQ-C30 - Fatigue Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144938|NCT00428597|Secondary|EORTC QLQ-C30 - Dyspnea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144939|NCT00428597|Secondary|EORTC QLQ-C30 - Diarrhea Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144940|NCT00428597|Secondary|EORTC QLQ-C30 - Constipation Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144941|NCT00428597|Secondary|EORTC QLQ-C30 - Appetite Loss Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144942|NCT00428597|Secondary|EORTC QLQ-C30 - Social Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144943|NCT00428597|Secondary|EORTC QLQ-C30 - Role Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144957|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-injection and immediately after injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||millimeters||Full Range|Mean
144944|NCT00428597|Secondary|EORTC QLQ-C30 - Physical Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144945|NCT00428597|Secondary|EORTC QLQ-C30 - Emotional Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144946|NCT00428597|Secondary|EORTC QLQ-C30 - Cognitive Functioning Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|PRO population. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles with less than 10 subjects are not reported due to lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144947|NCT00428597|Secondary|European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal|Patient Reported Outcome (PRO) population=subjects from the ITT population who had completed at least 1 EORTC QLQ-C30 assessment while on treatment. n=number of subjects with EORTC QLQ-C30 score at each specified time point. Data in cycles beyond Cycle 10 are not reported due to few subjects and lack of statistical reliability.||scores on a scale||Standard Deviation|Mean
144948|NCT00428597|Secondary|Overall Survival (OS)|Time in months from time of randomization to date of death due to any cause. The median number of months is provided; however, the study was terminated early. OS data was not mature by the time of analysis. Median OS time cannot be accurately estimated by Kaplan-Meier method for either treatment arm.|From start of study treatment up to 22 months|ITT. The median OS in months could not be calculated for placebo.||months||95% Confidence Interval|Median
144949|NCT00428597|Secondary|Time-to-Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. TTR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for TTR; no placebo subjects reported CR or PR.||Months||Full Range|Median
144950|NCT00428597|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 8 sunitinib subjects reported CR or PR response and were analyzed for DR; no placebo subjects reported CR or PR.||Months||Full Range|Median
144951|NCT00428597|Secondary|Number of Subjects With Objective Response|Objective response = subjects with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) for at least 4 weeks, confirmed by repeat tumor assessments. A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter|ITT. No placebo subjects had objective response.||participants|||Number
144952|NCT00428597|Primary|Progression Free Survival (PFS)|Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.|From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death|Intent-to-treat (ITT) population = all subjects who were randomized.||Months||95% Confidence Interval|Median
144953|NCT00428584|Other Pre-specified|Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection||Pre-injection and 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||Millimeters||Full Range|Mean
144954|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Diameter in Injection Site Redness||1 to 72 hours post injection|3 subjects discontinued and withdrew consent from the Betaseron to Rebif New Formulation Group in the Extension Phase||Millimeters||Standard Deviation|Mean
144955|NCT00428584|Other Pre-specified|Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection||Pain free patients at 30 minutes post injection|3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase||Participants|||Number
144958|NCT00428584|Secondary|Diameter of Injection Site Redness|Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection|1-72 hours post injection over the first 12 weeks including the titration period|One subject from the new formulation of rebif group discontinued due to pregnancy||mm||Standard Deviation|Mean
144959|NCT00428584|Secondary|Number of Pain Free Patients at 30 Minutes Post-injection|"A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used.~Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population."|30 minutes post injection|One subject from the new formulation of rebif group discontinued due to pregnancy||Participants|||Number
144960|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection.|Pre-injection to 10 minutes post-injection|One subject from the new formulation of Rebif group discontinued due to pregnancy||Millimeters||Full Range|Mean
144961|NCT00428584|Secondary|Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints|A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.|Pre-Injection to Immediately after Injection|One subject from the new formulation of rebif group discontinued due to pregnancy||millimeters||Full Range|Mean
144962|NCT00428584|Primary|Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints|Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection|From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron|One subject from the new formulation of rebif group discontinued due to pregnancy therefore, data for the Full Dose Calculation 30min Mean Change was not calculated||mm||Full Range|Mean
144963|NCT00428441|Secondary|Mortality||3 months||||||
144964|NCT00428441|Secondary|Incidence of Major Bleeding in Patients Who Resumed Oral Anticoagulant Therapy||3 months||||||
144965|NCT00428441|Secondary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients Who Resumed Oral Anticoagulant Therapy||3 months||||||
144966|NCT00428441|Primary|Rate of Patients With Altered D-dimer Levels and Temporal Distribution of Alterations||3 months||||||
144967|NCT00428441|Primary|Recurrent Deep Vein Thrombosis or Pulmonary Embolism in Patients With Persistently Negative D-dimer Levels|Objectively documented deep vein thrombosis, pulmonary embolism, superficial vein thrombosis|1 year|||participants|||Number
144968|NCT00428389|Secondary|Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study|The ADCS-ADL scale is composed of 23 items to assess the basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions. Responses for each item are obtained through a caregiver interview. The total score is the sum of all items and sub-questions. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at the end of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
144969|NCT00428389|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.|The NPI-10 assesses a wide range of behavior problems encountered in dementia patients. The 10 behavioral domains comprising the NPI-10 are evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 10 domains yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement.|Baseline, Week 25 (end of the extension phase) and at End of Study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
144970|NCT00428389|Secondary|Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study|The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement.|Baseline and Week 25 (end of the extension phase) and at the end of study|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
144971|NCT00428389|Secondary|Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25|The CGIC is an assessment tool used by a skilled clinician to make a judgment of the severity or a change of a patient’s condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) “very much improved” to (4) “no change” to (7) “very much worse”.|Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase)|The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC).||Scores on a scale||Standard Deviation|Mean
144972|NCT00428389|Secondary|Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to any reason during extension phases of the study.|From week 5 through the end of extension phase (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.||Participants|||Number
144973|NCT00428389|Secondary|Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study|A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer’s disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study.|Baseline through the end of study (25 weeks)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.||Participants|||Number
144974|NCT00428389|Primary|Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study|The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer’s disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase.|Baseline through the end of the core phase of the study (Week 5)|The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received.||Participants|||Number
144975|NCT00428246|Secondary|Effect of Paricalcitol on Kidney Function||6 weeks||||||
144976|NCT00428246|Secondary|Effect of Paricalcitol on Hypertension||6 weeks||||||
144977|NCT00428246|Primary|Endothelial Protectant Effects of Paricalcitol||6 weeks||||||
144978|NCT00428246|Primary|Anti-Inflammatory Effects of Paricalcitol|change in hsCRP level from baseline to 4 weeks|6 weeks|||micrograms||95% Confidence Interval|Mean
144979|NCT00428220|Other Pre-specified|Summary of Duration of Clinical Benefit|Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.|From the first day of treatment in parent study until last day of treatment in A6181114 study.|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.||Weeks||Standard Deviation|Mean
144980|NCT00428220|Primary|Number of Participants With Treatment-emergent AEs (Treatment-Related)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.||participants|||Number
144981|NCT00428220|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)|Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.|From first day of treatment on the current study up to 28 days post the last dose of study treatment|The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.||participants|||Number
144982|NCT00428116|Secondary|Morbidity|severe adverse events including death, pneumonia, diarrhea, and other adverse events|18 months post-randomization|||participants|||Number
144983|NCT00428116|Primary|Growth at 18 Months Post-randomization|Weight and height will be transformed to the weight-for-age Z-score (i.e., WAZ) and height-for-age Z-score (i.e., HAZ) using World Health Organization Child Growth Standards, taking into account the infant's age and gender.|18 months of post-randomization follow-up|||z-score||Inter-Quartile Range|Median
144984|NCT00428077|Secondary|Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.||Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.||||||
144985|NCT00428077|Primary|Correlation of Response With Specific HLA Types||12-24 Months||||||
144986|NCT00428077|Primary|Immunologic Response Over 1 Year||12 months||||||
144987|NCT00428077|Primary|Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions||12-24 Months||||||
144988|NCT00428077|Primary|Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts||12-24 Months||||||
144989|NCT00428077|Primary|Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.|One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.|Every 3 months for the duration of the 1-year treatment period. .|Per protocol.||Participants|||Number
144990|NCT00427999|Secondary|Quality of Life Assessed With EORTC-30|Health-related quality of life was assessed with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-30) questionnaire and was presented descriptively. The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.|baseline and Final Visit (week 24)|Intent to Treat (ITT) includes the 61 patients treated||scores on a scale||Standard Deviation|Mean
144991|NCT00427999|Secondary|Overall Survival Rate|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. The median time to overall survival rate was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||days||95% Confidence Interval|Median
144992|NCT00427999|Secondary|Time to Progression-free Survival|Progression-free survival, defined as the time from first administration of study drugs to the first PSA value of a PSA non-responder. Responders will be censored with date of PSA response for the analysis. The median time to PSA progression free survival was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||days||95% Confidence Interval|Median
144993|NCT00427999|Secondary|Time to PSA Response|Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved|every 4 weeks up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||days||95% Confidence Interval|Median
144994|NCT00427999|Primary|PSA Response Rate|To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for > 5 ng/ml.|up to 24 weeks|Intent to Treat (ITT) includes the 61 patients treated.||participants|||Number
144995|NCT00427973|Post-Hoc|Discontinued Treatment Due to SAE|Participants that discontinued treatment due to a Serious Adverse Event (SAE)|May 2009 through January 2010|||Participants|||Number
144996|NCT00427973|Secondary|Overall Survival|Overall survival will be calculated using the Kaplan-Meier method, and confidence limits for survival estimates will be calculated using the Greenwood formula.|The time from study entry until death from any cause, assessed up to 1 year|||months||95% Confidence Interval|Median
144997|NCT00427973|Secondary|Response Rate|"Number of patients who achieve either complete or partial response based on RECIST Criteria for target lesions assessed by MRI.~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|Up to 1 year|Patients receiving AZD2171 (cediranib maleate)||participants with confirmed response|||Number
144998|NCT00427973|Primary|Progression-free Survival|"Progression is defined as a 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions by conventional RECIST based criteria, or death, which ever comes first.~This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%."|3 months|The number of patients who were progression free at 3 months was determined. 13 of 17 patients (77%) were progression free at 3 months.||percentage of participants||95% Confidence Interval|Number
144999|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category.|"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
145000|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in ApoB/ApoA1 Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in ApoB/ApoA1 Ratio|||Number
145001|NCT00427960|Secondary|The Percentage Change From Baseline(Week 6) in Non-HDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in Non-HDL-C/HDL-C Ratio|||Number
145002|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in TC/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in TC/HDL-C Ratio|||Number
145003|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in LDL-C/HDL-C Ratio|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in LDL-C/HDL-C Ratio|||Number
145004|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-A1 (ApoA1)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in ApoA1|||Number
145005|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in Apolipoprotein-B (ApoB)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in ApoB|||Number
145006|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6)in Non-HDL-C|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in Non-HDL-C|||Number
145007|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies Guideline (JBS 2) Target of TC <4 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
145008|NCT00427960|Secondary|The Percentage Change From Baseline (Week 6) in High-density Lipoprotein Cholesterol (HDL-C)|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in HDL-C|||Number
145009|NCT00427960|Secondary|The Percentage Change From Baseline(week6) in TC|Derived according to the following formula: 100*[Lipid at week 12 - Lipid at week 6]/Lipid at week 6|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in TC|||Number
145010|NCT00427960|Secondary|The Percentage of Participants Reaching the European (EAS) Targets of LDL-C<2.5 or 3.00 mmol/L, Depending on Risk Category, and the Combined LDL-C and TC Target of LDL-C<2.5 or 3.0 mmol/L and TC<4.5 or 5.0 mmol/L, Both Depending on Risk Category.|"Risk categories are:~Symptomatic Asymptomatic, total risk <5% Asymptomatic, total risk ≥5%, baseline LDL-C<3 mmol/L and baseline TC<5 mmol/L Asymptomatic, total risk ≥5%, baseline LDL-C ≥3 mmol/L or baseline TC ≥5 mmol/L~Patients are defined as symptomatic if they meet at least 1 of the following criteria:~History of cardiovascular disease Type II diabetes or diabetes of unknown type Baseline TC ≥8 mmol/l Baseline LDL-C ≥6 mmol/l Baseline systolic BP ≥180 mmHg Baseline diastolic BP ≥110 mmHg~Total risk is derived from age, sex, TC, systolic BP and smoking status."|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
145011|NCT00427960|Secondary|The Percentage of Participants Reaching the Joint British Societies’ Guideline (JBS 2) Targets of TC <4 mmol/L and LDL-C <2 mmol/L||6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
145012|NCT00427960|Secondary|The Percentage of Participants Reaching the General Medical Services (GMS) Contract Target of Total Cholesterol (TC) <5 mmol/L||6 weeks (Baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percentage of Participants|||Number
145013|NCT00427960|Primary|Percentage Change in Low Density Lipoprotein - Cholesterol (LDL-C)|Calculated as LDL-C at Week 6 - LDL-C at Week 12] * 100|6 weeks (baseline) and 12 weeks|Intention to treat (ITT) population (all randomized patients).||Percent Change in LDL-C|||Number
145014|NCT00427934|Secondary|Time for Cmax (Tmax) for MTX at Screening and Week 1 and Maraviroc at Week 1|PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.||hr||Full Range|Median
145015|NCT00427934|Secondary|Maximum Observed Concentration (Cmax) During the Dosing Interval for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of Cmax of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.||ng/mL||Standard Deviation|Geometric Mean
145016|NCT00427934|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Four Hours Postdose (AUC 0-4) for MTX at Screening and Week 1 and Maraviroc at Week 1|Effect of maraviroc on the PK of MTX (comparison of AUC0-4 of MTX at screening versus at Week 1 after coadministration with 150 mg or 300 mg of maraviroc). PK was assessed at screening (MTX) and at Week 1 (maraviroc and MTX).|Screening (1, 2, 3, and 4 hours post-dose), Week 1 (0.5, 1, 2, 3, and 4 hours post-dose)|All available PK data from the Safety/PK Component were included.||ng.hr/mL||Standard Deviation|Geometric Mean
145017|NCT00427934|Secondary|Survival Analysis of Time to Withdrawal: Proportion of Subjects Who Did Not Withdraw From the Study Due to Lack of Efficacy.|Withdrawal due to lack of efficacy was collected based on the investigator’s judgement. Time to withdrawal was measured by the probability that a subject did not withdraw due to lack of efficacy by a particular visit. This was a statistical estimate (Kaplan-Meier Survival Analysis) of the probability that a participant would not withdraw due to lack of efficacy.|Weeks 1 to 12|FAS||proportion|||Number
145018|NCT00427934|Secondary|Number of Subjects With Withdrawal From Study Due to Lack of Efficacy|Withdrawal is the total number of withdrawals from the study. Withdrawal due to lack of efficacy was collected based on the investigator’s judgement.|16 weeks|FAS||participants|||Number
145019|NCT00427934|Secondary|Change From Baseline in SF-36 Mental Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) [12] is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (mental component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS||scores on a scale||Standard Error|Least Squares Mean
145020|NCT00427934|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary at Weeks 4 and 12|The SF-36 v.2 (Acute version) is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept (physical component score) are scored to yield values between 0 (worst) and 100 (best). Change from baseline at Weeks 4 and 12 were analyzed for SF-36. Due to the termination of the study, SF-36 results for the PK component group were not analyzed.|Baseline, Weeks 4 and 12|FAS||scores on a scale||Standard Error|Least Squares Mean
145021|NCT00427934|Secondary|Number of Subjects With Categorical Absolute ECG Parameters and ECG Changes Compared to Baseline|Maximum QTcB, QTcF, and QTc intervals were defined as 450 to < 480 msec, 480 to < 500 msec, or > = 500 msec.|Baseline, 16 weeks|FAS||Participants|||Number
145022|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used.|Baseline, 16 weeks|FAS||bpm||Standard Deviation|Mean
145023|NCT00427934|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (RR Interval, PR Interval, QRS Complex, QT Interval, Corrected QT [QTc] Interval, QTcB Interval [Bazett's Correction], QTcF Interval [Fridericia's Correction]).|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were used. QTc interval was not measured for the PK populations.|Baseline, 16 weeks|FAS||msec||Standard Deviation|Mean
145024|NCT00427934|Secondary|Number of Subjects With Categorical Absolute Vital Signs and Vital Sign Changes Compared to Baseline|Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Maximum increase from baseline in supine and standing systolic BP was > = 30 mmHg, and maximum increase from baseline in supine and standing diastolic BP was > = 20 mmHg.|Baseline, 16 weeks|FAS||Participants|||Number
145025|NCT00427934|Secondary|Change From Baseline in Mean Heart Rate|Heart rate = standing and supine at the same time the orthostatic BP measurements were obtained. Baseline was defined to be the latest non-missing value from a range of pre-treatment visits. Means of replicate values were not used.|Baseline, 16 weeks|FAS||beats per minute (bpm)||Standard Deviation|Mean
145026|NCT00427934|Primary|American College of Rheumatology (ACR) 20% Responders at Week 12|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain (Visual Analogue Scale [VAS]), Patient’s Global Assessment of Arthritis (VAS), Physician’s Global Assessment of Arthritis (Categorical), Health Assessment Questionnaire – Disability Index (HAQ-DI), and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) was defined as an intent-to-treat analysis set that included all subjects randomized to treatment who had taken at least 1 dose of study medication. Missing values were imputed by the method of last observation carried forward (LOCF).||Participants|||Number
145027|NCT00427934|Secondary|Change From Baseline in Mean Orthostatic Blood Pressure (BP)|Supine BP was recorded after 5 minutes lying down; subjects then sat for 2 minutes then stood for 2 minutes and standing BP was recorded. Orthostatic BP = either a systolic BP drop > 20 mmHg, or diastolic BP drop > 10 mmHg and/or drop in systolic BP < 90 mmHg. If a subject met the orthostatic criteria, they were required to complete 2 additional readings to provide a triplicate reading. The means of replicate BP values were used in the analysis. Baseline = the latest non-missing value from a range of pre-treatment visits. Change from baseline to Week 16 was analyzed for orthostatic BP.|Baseline, 16 weeks|FAS||mmHg||Standard Deviation|Mean
145028|NCT00427934|Secondary|Change From Baseline in Disease Activity Score Using CRP (DAS28-4[CRP]) at Weeks 1, 2, 4, 8, and 12|"DAS28-4 (CRP) was calculated using the following formula:~DAS28- 4(CRP) = 0.56 √28 Tender Joint Count + 0.28 √28 Swollen Joint Count + 0.36*natural logarithm(CRP + 1) + 0.014*Patient Global Assessment + 0.96. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at each visit was analyzed for DAS28-4 (CRP). The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 DAS28-4 (CRP) data were collected, but not analyzed."|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||mg/L||Standard Error|Least Squares Mean
145029|NCT00427934|Secondary|Change From Baseline in CRP at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit were analyzed for CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 CRP data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||mg/L||Standard Error|Least Squares Mean
145030|NCT00427934|Secondary|Change From Baseline in HAQ-DI at Weeks 1, 2, 4, 8, and 12|HAQ-DI assesses degree of difficulty experienced in daily activity categories (dressing/grooming, arising, eating, walking, hygiene, reach, grip and other activities) over the past week. There are 20 questions and difficulty is scored from 0 (none), 1 (some), 2 (much) and 3 (unable to do). Scores were then averaged to give the disability index (scale of 0 to 3). Change from baseline at each visit was analyzed. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 HAQ-DI data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS.||scores on scale||Standard Error|Least Squares Mean
145031|NCT00427934|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|Physician's evaluation based on subject’s disease signs, functional capacity and physical exam. Response recorded using 5-point scale: 1=Very Good, 2=Good, 3=Fair, 4=Poor and 5=Very Poor. Change from baseline at each visit was analyzed for Physician’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy thus Week 16 Physician's Global Assessment of Arthritis Pain data were collected but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||scores on scale||Standard Error|Least Squares Mean
145032|NCT00427934|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|Subjects answered: “Considering all the ways your arthritis affects you, how are you feeling today?” Subjects responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. Change from baseline at each visit was analyzed for Patient’s Global Assessment. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Global Assessment of Arthritis Pain data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||scores on scale||Standard Error|Least Squares Mean
145033|NCT00427934|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, and 12|The severity of arthritis was scored by the subject between 0 (no pain) and 100 (most severe pain) on a 100 mm VAS. Change from baseline at each visit was analyzed for Patient’s Assessment of Arthritis Pain. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 Patient's Assessment of Arthritis Pain data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||scores on scale||Standard Error|Least Squares Mean
145034|NCT00427934|Secondary|Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for swollen joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, MCP joints, PIP joints, and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 swollen joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||joint count||Standard Error|Least Squares Mean
145035|NCT00427934|Secondary|Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, and 12|Change from baseline at each visit was analyzed for tender/painful joint count. Twenty-eight tender and swollen joint scores included the same joints: shoulders, elbows, wrists, metacarpophalangeal joints (MCP), proximal interphalangeal joints (PIP), and the knees. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 tender/painful joint count data were collected, but not analyzed.|Baseline, Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||joint count||Standard Error|Least Squares Mean
145036|NCT00427934|Secondary|ACR 70% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 70 responder if: the counts for both tender and swollen joints had reduced by 70% or more from baseline; and 3 out of the following 5 assessments showed reduction of 70% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 70% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||Participants|||Number
145037|NCT00427934|Secondary|ACR 50% Responders at Weeks 1, 2, 4, 8, and 12|A subject was an ACR 50 responder if: the counts for both tender and swollen joints had reduced by 50% or more from baseline; and 3 out of the following 5 assessments showed reduction of 50% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 50% data were collected, but not analyzed.|Weeks 1, 2, 4, 8, and 12|FAS. Missing values were imputed by the method of LOCF.||Participants|||Number
145038|NCT00427934|Secondary|ACR 20% Responders at Weeks 1, 2, 4, and 8|A subject was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline assessment: Patient’s Assessment of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s Global Assessment of Arthritis, HAQ-DI, and CRP. The Week 16 visit (follow-up) was designed for safety rather than efficacy, thus Week 16 ACR 20% data were collected, but not analyzed.|Weeks 1, 2, 4, and 8|FAS. Missing values were imputed by the method of LOCF.||Participants|||Number
145039|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Units on scale||Standard Deviation|Mean
145040|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Presenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the ITT population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Units on scale||Standard Deviation|Mean
145041|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Absenteeism|The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.|Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||units on a scale||Standard Deviation|Mean
145042|NCT00427921|Secondary|Urinalysis - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks|||number||Standard Deviation|Mean
145043|NCT00427921|Secondary|Clinical Chemistry - Change From Baseline to Final Visit|Changes from the Group mean at Baseline are compared to the final visit Group mean value|Up to 24 weeks|||number||Standard Deviation|Mean
145044|NCT00427921|Secondary|Hematology - Change From Baseline to Final Visit|Changes from the Group mean at baseline are compared to the final visit Group mean value|Up to 24 weeks|||number||Standard Deviation|Mean
145045|NCT00427921|Secondary|Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment|"Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity).~Minimal clinically important difference = 7 points. Measure is Mean percent change."|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Units on scale||Standard Deviation|Mean
145046|NCT00427921|Secondary|50% Improvement in Draining Fistula Count and Fistula Healing|"Decrease in draining fistula is beneficial. 50 percent improvement refers to a reduction in the number of baseline fistula by 50 percent."|Week 12, Week 24, Last Assessment Value (last nonmissing value)|Intent To Treat||participants|||Number
145047|NCT00427921|Secondary|Employment Status: Number of Subjects Employed|Summary of employment status of those employed.|Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||participants|||Number
145048|NCT00427921|Secondary|Overall Health Care Resource Utilization|"From the Overall Health Care Resource Utilization Questionnaire: Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization."|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||number of visits||Standard Deviation|Mean
145049|NCT00427921|Post-Hoc|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline|Quality of life questionnaire for patients with IBD consisting of 4 domains: systemic, social, emotional, and bowel. This is a 10-item questionnaire, and all items are reported with a 7-point scale (ranging from 1 = poor HRQOL, to 7 = optimum HRQOL). Total SIBDQ score ranges from 10 (quality of life has been negatively affected tremendously by IBD) to 70 (quality of life is barely impacted by IBD). A change greater than 9 points was the minimal clinically important difference (MCID).|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||units on a scale||Standard Deviation|Mean
145076|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH<4.0|Percentage time with pH<4 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)|||Percentage||Standard Deviation|Mean
145050|NCT00427921|Primary|Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.|Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||Percentage of injections||Standard Deviation|Mean
145051|NCT00427921|Primary|Total Number of Injections of Adalimumab|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||injections||Standard Deviation|Mean
145052|NCT00427921|Secondary|Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).|Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.|Week 12, Week 24, and Last Assessment Value (last nonmissing value)|||number of fistulas||Standard Deviation|Mean
145053|NCT00427921|Post-Hoc|Harvey-Bradshaw Index (HBI) Mean Change From Baseline|HBI score (range 0-30) sum subtotal of 5 parameters of subject's CD activity: a)Well being 0=very well-4=terrible b) Abdominal pain 0=none- 3=severe c) Number liquid stools per day d) Abdominal mass 0=none-3=tender e) Complications: 1 point each. Decrease indicates improvement. Absolute decrease of 3 units on scale is clinically important.|Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)|Intent to Treat - subjects who received at least one dose of study drug.||Units on scale||95% Confidence Interval|Mean
145054|NCT00427921|Primary|Mean Extent of Exposure - Duration in Days|Extent of exposure for all adalimumab treated subjects|Up to 24 weeks|In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.||days||Standard Deviation|Mean
145055|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Systemic events reported using an electronic diary. Systemic events are any fever >=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
145056|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 38 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever >40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
145057|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
145058|NCT00427895|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation [lim] present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.||Percentage of participants||95% Confidence Interval|Number
145059|NCT00427895|Secondary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination|Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.||mcg/mL||95% Confidence Interval|Geometric Mean
145077|NCT00427635|Secondary|Change From Baseline in Mean Acid Clearance Time|Based on 24-hour impedance monitoring data|Baseline and end of treatment (10-14 days)|||Seconds||Standard Deviation|Mean
145060|NCT00427895|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.||Fold Rise||95% Confidence Interval|Geometric Mean
145061|NCT00427895|Secondary|Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||Percentage of participants||95% Confidence Interval|Number
145062|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group|Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1 and One month after vaccination 2/Year 3 to 4|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titers||95% Confidence Interval|Geometric Mean
145063|NCT00427895|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination 1|Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.||percentage of participants||95% Confidence Interval|Number
145064|NCT00427895|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1|Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination 1|Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.||titer||95% Confidence Interval|Geometric Mean
145065|NCT00427804|Primary|Fractional Absorption of Calcium|Fractional absorption of calcium (see citation for complete details)|7 week|||Percentage of absorption|||Number
145066|NCT00427804|Primary|Intestinal Absorption of Calcium||12 Weeks||||||
145067|NCT00427791|Secondary|Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days|Number of participants with incidence of acute graft versus host disease (aGVHD) during first 100 days following transplant.|During the first 100 days following transplant|Analysis was by protocol.||participants|||Number
145068|NCT00427791|Primary|Progression-free Survival (PFS)|Time from randomization to first progression or death, whichever comes first, measured in months.|2 Years post transplant or until disease progression or death|Analysis was by protocol. Participants were randomized between Etoposide + Total body irradiation and Etoposide + Total body irradiation + Rituximab using a Bayesian adaptive algorithm.||Months||Standard Deviation|Median
145069|NCT00427765|Primary|Average Overall Survival Time|Average number of years for survival post transplant where overall survival time is measured from date of transplant to disease progression or death for any reason.|Baseline(transplantation) to disease progression or death for any reason, up to 6 years.|Analysis by protocol||years||Full Range|Mean
145070|NCT00427700|Secondary|Serum Levels of Progesterone|The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation.|8-10 days after ovulation|Intention to treat.Cases that were lost to follow-up observation, dropped out of the study, failed to collect progesterone on days 22 to 24, and lacked menses after medroxyprogesterone acetate treatment were considered as failures according to the intention-to-treat analysis.||ng/mL||95% Confidence Interval|Mean
145071|NCT00427700|Primary|Percentage of Participants With Ovulation Detected by Ultrasound|Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.|cycle day 14-20|intention to treat.||percentage of participants||95% Confidence Interval|Number
145072|NCT00427661|Secondary|Incidence of Grade 2-4 Acute GVHD.||100 days|||participants with grade 2-4 AGVHD|||Number
145073|NCT00427661|Primary|Engraftment at 1 Year Post BMT.|Measurement of total PBMC chimerism|1 year|||participants|||Number
145074|NCT00427661|Primary|Development of GVHD Within 1 Year of BMT|GVHD is assessed by physical exam, bloodwork and biopsy.|1 year|||participants|||Number
145075|NCT00427635|Secondary|Change From Baseline in Percentage Time With pH Within 4.0-6.9|Percentage time with pH 4.0-6.9 during 24-hour pH monitoring|Baseline and end of treatment (10-14 days)|||Percentage||Standard Deviation|Mean
145085|NCT00427635|Secondary|Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux|Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)|||Mean Number of Events||Standard Deviation|Mean
145086|NCT00427635|Primary|Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring|The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.|Baseline and end of treatment (10-14 days)|||Mean Number of Events||Standard Deviation|Mean
145087|NCT00427557|Primary|Number of Participants With Engraftment|Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment.|Baseline to 100 days post-engraftment|Analysis per protocol.||participants|||Number
145088|NCT00427349|Secondary|Objective Response Rate|Tumor response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by the total number of analyzable patients. CR is defined as complete disappearance of all tumor lesions, and partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|assessed every 8 weeks while on treatment, and frequency of tumor measurements during follow-up were determined by the treating physician, assessed up to 5 years|||percentage of participants||90% Confidence Interval|Number
145089|NCT00427349|Secondary|Overall Survival|Overall survival (OS) is defined as the time from registration until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method , with 95% confidence intervals calculated using Greenwood’s formula|assessed every 3 months if patient is < 2 years from study entry, then every 6 months up to 5 years|All eligible and treated patients||months||95% Confidence Interval|Median
145090|NCT00427349|Primary|Four-month Progression-free Survival Rate|Four-month progression-free survival (PFS) rate is defined as number of patients who are still progression free at 4 months after study entry divided by number of eligible and treated patients enrolled to the study. Progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s), or unequivocal progression of existing non-target lesions.|assessed every 4 weeks while on treatment and at three months post-treatment for participants treated for one cycle, up to month four|The analysis population includes all 44 eligible and treated patients. But 2 patients did not have disease assessment after study entry and are excluded from the analysis.||percentage of participants||90% Confidence Interval|Number
145091|NCT00427336|Primary|Number of Patients With Engraftment Response|Engraftment defined as (1) the first of three consecutive days of an Absolute neutrophil count (ANC) >500/mL (b) the first of seven consecutive days of an unsupported platelet count 20,000. Patient needs to survive at least 28 days to be evaluable for engraftment. Chimerism studies need to demonstrate donor-derived hematopoiesis (>90%)|First 100 days post transplant.|||Participants|||Number
145092|NCT00427037|Primary|25-hydroxyvitamin D|25-hydroxyvitamin D measured in serum by ELISA|3 months|||ng/mL||95% Confidence Interval|Mean
145093|NCT00427037|Secondary|Bone Turnover Marker-CTX|Blood levels of C-telopeptide|12 weeks|||pg/mL||95% Confidence Interval|Geometric Mean
145094|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|The UPDRS is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||scores on a scale||Standard Deviation|Mean
145095|NCT00427011|Secondary|Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study|Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||scores on a scale||Standard Deviation|Mean
145096|NCT00427011|Secondary|Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||hours||Standard Deviation|Mean
145097|NCT00427011|Primary|Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 12, Week 20, Week 32, Week 44, Week 56|Safety population.||hours||Standard Deviation|Mean
145098|NCT00426855|Primary|Optimal Bendamustine Dosage for Further Studies||Three weeks after treatment termination|||mg/m^2|||Number
145099|NCT00426842|Primary|Systolic Blood Pressure|brachial artery systolic blood pressure (mmHg)|The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position.|||mmHg||Standard Deviation|Mean
145321|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||10^9 cells/L||Standard Deviation|Mean
145100|NCT00426764|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG scale is as follows:~Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.~Data reported is the shift from Baseline ECOG score to best on-study assessment score."|From Baseline to 31 March 2010 (up to 33.4 months).|Safety population.||participants|||Number
145101|NCT00426764|Secondary|Time to Disease Progression|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.||Days||95% Confidence Interval|Median
145102|NCT00426764|Secondary|Duration of Complete Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population with a complete response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.||days||95% Confidence Interval|Median
145103|NCT00426764|Secondary|Duration of Objective Disease Response|Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histopathologically-Confirmed Population with an objective response. Censoring for patients who did not have a date of progression was conducted based on last assessment reported for the patient.||days||95% Confidence Interval|Median
145104|NCT00426764|Secondary|Percentage of Participants With Objective Disease Response|Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses & extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histologically Confirmed Population. Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.||percentage of participants||95% Confidence Interval|Number
145105|NCT00426764|Primary|Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee|Complete Response (CR): >75% decrease in size aggregate of nodal index lesions (large and small), complete disappearance of extranodal and non-index lesions; total disappearance of clinical disease including skin involvement; disease-related signs and symptoms, normalization of biochemical abnormalities and reduction in size of spleen or liver so no longer palpable. Unconfirmed CR: all above criteria except all nodal index lesions must have regressed >75% in the sum of the product diameters (SPD) from baseline. Individual nodes previously confluent must have regressed by >75% in their SPD.|Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days).|Histologically Confirmed Population, comprised all enrolled patients who received at least 1 dose of study treatment and who had histopathologically confirmed peripheral T-cell lymphoma(s). Patients who discontinued prior to any response evaluation or who had no post-baseline assessment of response were classified as non-responders.||percentage of participants||95% Confidence Interval|Number
145106|NCT00426751|Secondary|Mean Duration of Stay in the Ward|Costs were measured as the duration of stay in the ward (outpatient, normal ward, and intensive care unit) within the specified timeframe was measured.|until 6 months after index-MI|ITT Population||days||Standard Deviation|Mean
145107|NCT00426751|Secondary|Number of Participants With Minor Bleedings (TIMI Classification)|The number of participants with minor bleedings (according to TIMI classification: clinically overt bleeding [e.g., gross haematuria or haematemesis) associated with a drop in haematocrit of ≥ 9% or a drop in haemoglobin of ≥ 3 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
145108|NCT00426751|Secondary|Number of Participants With Major Bleedings (TIMI Classification)|Number of participants with major bleedings (according to TIMI classification: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
145109|NCT00426751|Secondary|Number of Participants With Heart Failure Until 6 Months After PCI|The number of participants with heart failure within 6 month after PCI was measured.|until 6 Months (Day 180) after index-MI|Safety Population||participants|||Number
145111|NCT00426751|Secondary|Number of Participants Who Experienced Stroke or Major Bleeding Complications|Number of participants who experienced stroke (hemorrhagic, non-hemorrhagic) or major bleedings (TIMI class: intracranial haemorrhage, spontaneous bleeding, bleeding at any instrumented site, retroperitoneal bleeding, or clinically significant overt haemorrhage associated with a drop in haematocrit of ≥ 15% or a drop in haemoglobin of ≥ 5 g/dL).|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
145112|NCT00426751|Secondary|Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)|The number of participants who died, and/or experienced re-MI or UTVR (individually counted) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population||participants|||Number
145113|NCT00426751|Secondary|Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)|The number of participants who died, experienced re-MI, or experienced UTVR (necessity of re-PCI of the target vessel or coronary artery bypass graft [CABG] because of recurrent ischaemic angina within 30 days after PCI) within the specified timeframe was measured.|Day 7 or hospital discharge; Day 30 after index-MI|Safety Population: All participants who received at least one dose of study medication.||participants|||Number
145114|NCT00426751|Secondary|Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI|The number of participants with the indicated myocardial blush grade (TMPG), used to assess the myocardial reperfusion in the infarcted myocardium following PCI (as assessed by the core angiography laboratory), was measured. Blush grades: 0 = failure of dye to enter the microvasculature; 1 = dye slowly enters but fails to exit the microvasculature; 2 = delayed entry and exit of dye from the microvasculature; 3: normal entry and exit of dye from the microvasculature. Blush that is of only mild intensity throughout the washout phase but fades minimally is also classified as grade 3.|after PCI|ITT Population||participants|||Number
145115|NCT00426751|Secondary|Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI|cTIMI frame counts (number of cineframes needed for dye to reach standardized distal landmarks in a coronary vessel; objective index of coronary blood flow) following PCI, as assessed by core angiography lab.|after PCI|ITT Population. Participants with un-evaluable angiographies were excluded from analysis.||number of frame counts||Standard Deviation|Mean
145116|NCT00426751|Secondary|Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI|The number of participants with TIMI grade 3 (complete perfusion) patency of the infarcted vessels following PCI, as assessed by core angiography lab, was measured.|after PCI|ITT Population||participants|||Number
145117|NCT00426751|Secondary|Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI|Number of participants with the respective patency of the infarcted vessels was evaluated by TIMI (Thrombolysis In Myocardial Infarction) flow grades (Grade 0 = No perfusion, Grade 1 = Penetration with minimal perfusion, Grade 2 = Partial perfusion, Grade 3 = Complete perfusion), as assessed by core angiography lab.|immediately before PCI|ITT Population||participants|||Number
145118|NCT00426751|Secondary|Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI|Max STE is measured similarly to single-lead STR, but was not compared with the ST deviation on the baseline ECG I. It was the existing ST deviation on the single ECG lead of maximum ST deviation present at 60 minutes after the PCI (ECG III).|60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.||millimeters (mm)||Standard Deviation|Mean
145119|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI|Mean sum STR was calculated as the difference between baseline (ECGI) and ECG II: the mean of the sum of ST elevation resolution from all ECG leads associated with infarct location. ST resolution was expressed as a percentage from baseline.|Baseline (ECG I) and immediately prior to PCI (ECG II)|ITT Population. Participants who did not have an ECG II immediately before PCI were excluded from analysis.||percent change||Standard Deviation|Mean
145120|NCT00426751|Secondary|Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1 -V4), whichever lead showed the largest deviation either at baseline or at follow-up, respectively. STR was expressed as a percentage from baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Participants with unevaluable ECGs were excluded from analysis.||percent change||Standard Deviation|Mean
145121|NCT00426751|Secondary|Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline.|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population. Some participants were un-evaluable with regard to the primary endpoint and were counted as failures. These participants were excluded from this analysis.||percent change||Standard Deviation|Mean
145122|NCT00426751|Secondary|Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI|Single lead STR is calculated as the difference (as a percentage) between baseline (ECG I) and ECG III of either the ST elevation on one of the leads (II, III, aVF, V5, and V6) or the ST depression of one of the precordial leads (V1- V4), whichever lead showed the largest deviation either at baseline or at ECG III, respectively (Complete: ≥ 70%; Partial: ≥ 30% and <70%).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population||participants|||Number
145123|NCT00426751|Secondary|Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI|Sum STR was calculated as the difference between baseline (ECGI) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline (Complete: ≥ 70% resolution; Partial: ≥ 30% and < 70% resolution; None: < 30% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|ITT Population||participants|||Number
145135|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL|Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
145124|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.||participants|||Number
145125|NCT00426751|Primary|Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)|Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).|Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)|Per Protocol (PP) Population: All randomized participants who received at least one dose of study drug, who had data that were fully evaluable for the primary endpoint, and who did not show any major protocol violation.||participants|||Number
145126|NCT00426660|Secondary|Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)|Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre-­treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV-­1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for genotypic changes in the V3 Loop of glycoprotein 120 (gp 120)."||participants|||Number
145127|NCT00426660|Secondary|Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau|Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on-­treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.|Baseline up to Week 144|"Safety analysis set. Here, number of participants analyzed signifies those participants who were assessed for maraviroc susceptibility."||participants|||Number
145128|NCT00426660|Secondary|Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure|Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Screening up to Week 144|Safety analysis set; N = participants with virologic failure (VF). Abbreviations: Scr = screening, R5 = CCR5 tropic HIV-1, X4=CXCR4 tropic HIV-1, DM = dual mixed, NR = non-reportable, Missing = participants with VF who did not have tropism result within specified screening period (Scr missing: -42 days to Day 0) or at the time of VF.||percentage of participants|||Number
145129|NCT00426660|Secondary|Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure|Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.|Baseline up to Week 144|Safety analysis set; N = number of participants with virologic failure.||percentage of participants|||Number
145130|NCT00426660|Secondary|Median Time to Virologic Failure|Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.|Day 1 up to Week 144|Safety analysis set. N = number of participants with virologic failure. For the calculation of the time to virologic failure, any visits with no data were excluded. Participants who were not virologic failures were censored at the last available observation.||days||Inter-Quartile Range|Median
145131|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count Percent|Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of lymphocytes||Standard Deviation|Mean
145132|NCT00426660|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||cells/uL||Standard Deviation|Mean
145133|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count Percent|Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of lymphocytes||Standard Deviation|Mean
145134|NCT00426660|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||cells/uL||Standard Deviation|Mean
145136|NCT00426660|Secondary|Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL|Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
145137|NCT00426660|Secondary|Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA|Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
145138|NCT00426660|Secondary|Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)|"Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.~Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference."|Baseline up to Week 144|Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.||percentage of participants|||Number
145139|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status|Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events. Abbreviations: HBV = hepatitis B virus, HBC = hepatitis C virus.||percentage of participants|||Number
145140|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age|Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.||percentage of participants|||Number
145141|NCT00426660|Primary|Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race|Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.||percentage of participants|||Number
145142|NCT00426660|Primary|Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender|Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.|Baseline up to Week 144|Safety analysis set; n = number of participants evaluable for adverse events.||percentage of participants|||Number
145143|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study by time on therapy were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.|||||
145144|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline/nadir CD4 cell counts were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.|||||
145145|NCT00426660|Primary|Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load||Baseline up to Week 144|Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline viral load were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.|||||
145146|NCT00426660|Primary|Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses|Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.|Baseline up to Week 144|Safety analysis set.||percentage of participants|||Number
145147|NCT00426660|Primary|Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.||percentage of participants|||Number
145148|NCT00426660|Primary|Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities|Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.|Baseline up to Week 144|Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.||percentage of participants|||Number
145149|NCT00426660|Primary|Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)|AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.|Baseline up to Week 144|Safety analysis set: all participants who were randomized and received at least one dose of study medication.||percentage of participants|||Number
149295|NCT00394654|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 27, 55, 84, and 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
145150|NCT00426556|Secondary|Phase II: Overall Survival (OS)|Overall survival (OS) is defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.|every 3 months until death|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Months||95% Confidence Interval|Median
145151|NCT00426556|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Months||95% Confidence Interval|Median
145152|NCT00426556|Secondary|Phase I: Best Overall Response (BOR)|BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR or SD >= 24 weeks).CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for partial disease (PD). PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Percentage of Participants|||Number
145153|NCT00426556|Primary|Phase II: Overall Response Rate|The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR). Only patients with measurable disease (the presence of at least one measurable lesion) at baseline were included in the study. CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|every 8 - 9 weeks until disease progression or a new lesion is identified|The Full Analysis Set (FAS) consisted of all patients who received a least one dose of any one compound of the study treatment. Patients were analyzed according to the everolimus dose level to which they enrolled.||Percentage of Participants|||Number
145154|NCT00426361|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).||Subjects|||Number
145155|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)|Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).||Subjects|||Number
145156|NCT00426361|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|During the 30-day period (Day 0-29) following vaccination|||Subjects|||Number
145157|NCT00426361|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria."|During the 7-day period (Day 0-6) following each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
145158|NCT00426361|Secondary|Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)|"Booster response to PT, FHA and PRN were defined as:~For initially seronegative subjects [pre-vaccination titer below cut-off value of 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)]: antibody titers at least 4 times the cut-off,~For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,~For initially seropositive subjects with pre-vaccination titer above 20 EL.U/mL: an increase in antibody titers of at least 2 times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
145191|NCT00425386|Primary|Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.|The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.|Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years|||milligrams|||Number
145159|NCT00426361|Secondary|Number of Subjects With Booster Response to Diphtheria and Tetanus|"Booster responses to diphtheria and tetanus were defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off value of 0.1 International Units per Milliliter): antibody titers at least four times the cut-off (post-vaccination titer greater than or equal to 0.4 IU/mL), and~For initially seropositive subjects (pre-vaccination titer greater than or equal to 0.1 IU/mL): an increase in antibody titers of at least four times the pre-vaccination titer."|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
145160|NCT00426361|Secondary|Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are given as Geometric Mean Titers (GMTs). The titer is a serum dilution giving 50 percent reduction of signal compared to control without serum.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||titer||95% Confidence Interval|Geometric Mean
145161|NCT00426361|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)|Anti-diphtheria and anti-tetanus antibodies cut-off value assessed include 1.0 IU/mL.|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
145162|NCT00426361|Secondary|Titers of Anti-diphtheria and Anti-tetanus Antibodies|Titers are given as Geometric Mean Titers (GMTs) and expressed as IU/mL.|One month after vaccination with Boostrix-Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||IU/mL||95% Confidence Interval|Geometric Mean
145163|NCT00426361|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month post Cervarix Dose 3 (Month 7/8)]|||EL.U/mL||95% Confidence Interval|Geometric Mean
145164|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Dose 1|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on subjects from the Cervarix and Cervarix + Boostrix Polio groups with available results for the defined antibody.||Subjects|||Number
145165|NCT00426361|Secondary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month post Cervarix Dose 3 (Month 7/8)|Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.||Subjects|||Number
145166|NCT00426361|Primary|Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3|Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio and with available results for the defined antigen.||Subjects|||Number
145167|NCT00426361|Primary|Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||EL.U/mL||95% Confidence Interval|Geometric Mean
145168|NCT00426361|Primary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).|One month after vaccination with Boostrix Polio|Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.||Subjects|||Number
145169|NCT00426283|Secondary|To Investigate the Change in Subject Symptoms and Response to FP.||3 months||||||
145170|NCT00426283|Secondary|To Investigate Subject Compliance and Response to FP.||3 months||||||
145171|NCT00426283|Secondary|To Investigate the Relationship Between Gene Expression, Blood Levels (CBC, Serum IL-5, Eotaxin-3 and IgE) Eosinophil Phenotype, (Via Flow Cytometry and Functional Responses) and Response to FP.||3 months||||||
145172|NCT00426283|Secondary|To Investigate the Relationship Between Subject Age, Height, Weight, Allergic Status and Response to FP.||3 months||||||
145173|NCT00426283|Secondary|To Investigate the Safety of 1760mcg FP in the Treatment of EE Using Measurement of Serial Salivary Cortisol Levels and Adverse Reaction Data.||3 months||||||
145174|NCT00426283|Primary|The Percentage of Participants Who Attained Remission.|Remission is considered achieved when the highest eosinophil count per high power field (hpf) in all esophageal biopsies is </= 1 eosinophil/hpf after 3 months of therapy.|3 months|||percentage of participants||95% Confidence Interval|Number
145209|NCT00425308|Secondary|Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12||From Baseline to Month 3, 6, and 12|Intent to Treat Population||µmol/L||Standard Deviation|Mean
145322|NCT00425061|Secondary|Blood Eosinophils Levels - Stage 1||Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||10^9 cells per liter (cells/L)||Standard Deviation|Mean
145175|NCT00426270|Secondary|Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7|The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention).|Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.||Percentage of participants|||Number
145176|NCT00426270|Secondary|Duration of the Clinical Response|The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.||Days||Standard Deviation|Mean
145177|NCT00426270|Secondary|Maximum Platelet Count|Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.|Day 2 to the end of the study (Day 63)|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.||*10^9/L||Standard Deviation|Mean
145178|NCT00426270|Secondary|Time to Achieve a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count. Only participants with a clinical response were included in the analysis.||Days||Standard Deviation|Mean
145179|NCT00426270|Primary|Percentage of Participants With a Clinical Response|A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.|Day 2 to Day 7|Full analysis set: All participants who received at least 1 dose of study medication, satisfied all major entry criteria, and had at least 1 post-baseline measurement of platelet count.||Percentage of participants|||Number
145180|NCT00426231|Secondary|Self-reported Medication Adherence|Only individuals with 6-month follow-up data were included in this analysis|6 months|||participants|||Number
145181|NCT00426231|Primary|Achievement of LDL-cholesterol Goals|Achieving the goal of an LDL cholesterol level of < 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.|6 months|||participants|||Number
145182|NCT00426153|Secondary|Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 12 months|||units on a scale||Standard Deviation|Mean
145183|NCT00426153|Secondary|Percent Change in Glomerular Filtration Rate (GFR)|Percent change from baseline in renal function/GFR, measured by clearance of iothalamate with monitoring of bladder emptying using ultrasound|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.||percent change||Standard Deviation|Mean
145184|NCT00426153|Secondary|Percent Change in Renal Volume|Percent change from baseline in renal volume, measured in milliliters by MRI or CT scans|Baseline, 12 months|13 subjects were excluded from the analysis of the kidney data: 4 subjects had renal transplant before enrollment (3 in octreotide and 1 in placebo groups), 8 subjects had a diagnosis of ADPLD (4 in each group), 1 placebo subject has missing kidney data due to incomplete image coverage.||percent change||Standard Deviation|Mean
145185|NCT00426153|Primary|Percent Change in Liver Volume|Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans|Baseline, 12 months|||percent change||Standard Deviation|Mean
145186|NCT00425386|Secondary|Maximum Percent Change in Tumor Measurement|The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD.|Baseline through end of study, up to 7 years|||percent change in size||Full Range|Mean
145187|NCT00425386|Secondary|Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease||From the start of treatment until the criteria for response is met.|||percentage of participants|||Number
145188|NCT00425386|Secondary|Median Time to Progression|The Kaplan-Meier method will be used to estimate the median time to progression.|For the duration of the study, up to 7 years|||months||95% Confidence Interval|Median
145189|NCT00425386|Secondary|To Determine the Safety of Sunitinib in Combination With Erlotinib||For the duration of the study, up to 7 years|||participants|||Number
145190|NCT00425386|Primary|Progression-free Survival at 8 Months|Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum).|8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney|||percentage of participants||95% Confidence Interval|Number
145192|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||Percentage of patients|||Number
145193|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||Percentage of patients|||Number
145194|NCT00425373|Secondary|Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||Percentage of patients|||Number
145195|NCT00425373|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
145196|NCT00425373|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)|At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.|Baseline to end of study (Week 8)|Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.||mm Hg||Standard Error|Least Squares Mean
145197|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).|Blood chemistry - C-reactive Protein (CRP) (mg/L)|From Baseline to Month 3, 6, and 12|Safety population||mg/L||Standard Deviation|Mean
145198|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.||From Baseline to Month 1, 3, 6, 9, and 12|Safety population||mmol/L||Standard Deviation|Mean
145199|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.||From Baseline to Month 3, 6, and 12|Safety population||mmol/L||Standard Deviation|Mean
145200|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.|Blood chemistry - total cholesterol (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population||mmol/L||Standard Deviation|Mean
145201|NCT00425308|Secondary|Assessing Cardiovascular Risk Factors Based on Fasting Glucose.|Blood chemistry - fasting glycemia (mmol/L)|From Baseline to Month 1, 3, 6, 9, and 12|Safety population||mmol/L||Standard Deviation|Mean
145202|NCT00425308|Secondary|Change in Renal Function Assessed by Microalbuminuria Month 3, Month 6 and Month 12||From Baseline to Month 3, 6, and 12||12/2010||||
145203|NCT00425308|Secondary|Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12|Change in proteinuria (g/24h) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population||g/24h||Standard Deviation|Mean
145204|NCT00425308|Secondary|Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12|Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12|From Baseline to Month 3, 6, and 12|Intent to Treat Population||mL/min/1.73m²||Standard Deviation|Mean
145205|NCT00425308|Secondary|Safety Assessed by Adverse Events and Serious Adverse Events||12 months||11/2010||||
145206|NCT00425308|Secondary|Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.||Month 12|Intent to Treat (ITT) Population||participants|||Number
145207|NCT00425308|Primary|Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. (Completed Patients)|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: completed patients||(mL/min)||Standard Error|Least Squares Mean
145208|NCT00425308|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.||Month 6 and 12|Intent to Treat Population||participants|||Number
145210|NCT00425308|Primary|Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.|Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)|From Baseline to Month 12|Intent to Treat (ITT) Population: all patients with a baseline value||(mL/min)||Standard Error|Least Squares Mean
145211|NCT00425945|Secondary|AST/SGOT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||u/L||Standard Deviation|Mean
145212|NCT00425945|Secondary|ALT/SGPT|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||u/L||Standard Deviation|Mean
145213|NCT00425945|Secondary|Hemoglobin A1c|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.||mg/dL||Standard Deviation|Mean
145214|NCT00425945|Secondary|Fasting Insulin|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||mg/dL||Standard Deviation|Mean
145215|NCT00425945|Secondary|Fasting Blood Glucose|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||mg/dL||Standard Deviation|Mean
145216|NCT00425945|Secondary|Weight|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||lb||Standard Deviation|Mean
145217|NCT00425945|Secondary|Body Mass Index|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||kg/m^2||Standard Deviation|Mean
145218|NCT00425945|Secondary|C-reactive Protein|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.||nmol/L||Standard Deviation|Mean
145219|NCT00425945|Secondary|Lipoprotein A|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)|three months|||nmol/L||Standard Deviation|Mean
145220|NCT00425945|Secondary|HDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||nm||Standard Deviation|Mean
145221|NCT00425945|Secondary|LDL Particle Size|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||nm||Standard Deviation|Mean
145222|NCT00425945|Secondary|Triglycerides|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|three months|||mg/dL||Standard Deviation|Mean
145223|NCT00425945|Secondary|HDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||mg/dL||Standard Deviation|Mean
145224|NCT00425945|Secondary|LDL|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||mg/dL||Standard Deviation|Mean
145225|NCT00425945|Secondary|Total Cholesterol|Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).|3 months|||mg/dL||Standard Deviation|Mean
145226|NCT00425945|Primary|Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.|Mean at Week 12 observation minus mean at Baseline observation.|three months|The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.||mm Hg||95% Confidence Interval|Mean
145227|NCT00425854|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)|Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.|day 29|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
145228|NCT00425854|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).|baseline till end of treatment|||participants|||Number
145229|NCT00425854|Secondary|Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)|LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.|Baseline and last assessment|TS||Participants|||Number
145230|NCT00425854|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death.|From randomisation to end of follow-up.|TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A.||days||95% Confidence Interval|Median
145231|NCT00425854|Primary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort B as CB was primary endpoint only for Cohort A.||Participants|||Number
145232|NCT00425854|Primary|Objective Response (OR)|OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B.||Participants with OR|||Number
145233|NCT00425854|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS||days||95% Confidence Interval|Median
145234|NCT00425854|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median duration of OR was not calcuable as there was no OR observed.|||||
145235|NCT00425854|Secondary|Time to OR|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. Median time to OR was not calcuable as there was no OR observed.|||||
145236|NCT00425854|Secondary|Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS. No data for Cohort A as CB was secondary endpoint only for Cohort B.||Participants with CB|||Number
145237|NCT00425750|Secondary|Progression-free Survival|Median duration of survival without disease progression, calculated as on-study date to date of progression or date of death (censored) or off-study date (censored)|7.55 months (average duration, on study to off study)|||Month||95% Confidence Interval|Median
145238|NCT00425750|Secondary|Overall Survival|Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)|7.55 months (average duration, on study to off study)|||Month||95% Confidence Interval|Median
145239|NCT00425750|Primary|Patient Response to Treatment|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|7.55 months (average duration, on study to off study)|||participants|||Number
145240|NCT00425698|Secondary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|6 month after transplantation||||||
145241|NCT00425698|Primary|Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation|42 days after transplantation|||ml/min||Standard Deviation|Mean
145242|NCT00425503|Primary|The Purpose of the Present Study is to Assess the Safety of PS-341 as a Pretreatment in Patients Who Are to Undergo a Radical Prostatectomy. Poor Wound Healing and Excessive Bleeding, With Historical Rates of <1% and 10% Respectively Will be Measured.|Pour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.|Poor wound healing (dehiscence of fascia during the first postoperative week) and bleeding 24 hours after surgery|||Events|||Number
145243|NCT00425438|Primary|Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event|CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
145244|NCT00425438|Secondary|Time to Treatment Failure|Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
145245|NCT00425438|Secondary|Percentage of Participants Terminating Treatment||Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
145246|NCT00425438|Secondary|Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR)|GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
145247|NCT00425438|Secondary|Percentage of Participants With Treatment Response Event by End of Treatment|Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
145248|NCT00425438|Secondary|Complete Response|The median time, in months, to CR was defined as the time from randomization to CR event.|Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48|Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.|||||
145249|NCT00425269|Secondary|Intake of Fish, Post Test||post-test, after completion of all six group sessions|||portions/week||Inter-Quartile Range|Mean
145250|NCT00425269|Secondary|Intake of Poultry, Post-test||post-test, after completion of all six group sessions|||portions/week||Inter-Quartile Range|Mean
145251|NCT00425269|Secondary|Intake of Red Meat, Post-test||post-test, after completion of all six group sessions|||portions/week||Inter-Quartile Range|Mean
145252|NCT00425269|Secondary|Intake of Soft Drinks With Added Sugar, Post-test||post-test, after completion of all six group sessions|||dl/week||Inter-Quartile Range|Mean
145253|NCT00425269|Secondary|Intake of Vegetables, Fruit and Fruit Juice, Post-test||post-test, after completion of all six group sessions|||grams per day||Inter-Quartile Range|Mean
145286|NCT00425113|Primary|Changes in TB Lesion Sizes Using High Resolution Computed Tomography (HRCT).|Lesions were defined as nodules (<2 mm, 2-<4 mm, and 4-10 mm), consolidations, collapse, cavities, fibrosis, bronchial thickening, tree-in-bud opacities, and ground glass opacities. Each CT was divided into six zones (upper, middle, and lower zones of the right and left lungs) and independently scored for the above lesions by three separate radiologists blinded to treatment arm. A fourth radiologist adjudicated any scores that were widely discrepant among the initial three radiologists. The HRCT score was determined by visually estimating the extent of the above lesions in each lung zone as follows: 0=0% involvement; 1= 1-25% involvement; 2=26-50% involvement; 3=51-75% involvement; and 4=76-100% involvement. A composite score for each lesion was calculated by adding the score for each specific abnormality in the 6 lung zones and dividing by 6, with the change in composite score measured at 2 and 6 months compared to baseline. Composite sums of all 10 composite scores are reported.|6 months.|||reader score||Standard Error|Mean
145287|NCT00425100|Secondary|Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)|Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.|Week 12|Subjects in safety set included subjects who took at least one dose of study drug. Missing responses to the Treatment Satisfaction Question at Week 12 were imputed as not satisfied for calculating the most conservative treatment satisfaction.||participants|||Number
145288|NCT00425100|Secondary|Sum Rating on the Urinary Sensation Scale|The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 “no feeling of urgency” to 5 “unable to hold; leak urine.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145289|NCT00425100|Secondary|"Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)"|Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically & results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.|Week 12|Population included subjects in FAS (described above) with non-missing values on OAB-S at Week 12, referred to in table below as All Subjects. Summary was presented for All Subjects and 2 subgroups, based on categorization for treatment satisfaction question used in primary endpoint assessing satisfaction.||scores on a scale||Standard Deviation|Mean
145290|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale|Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145291|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145292|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145293|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145294|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145295|NCT00425100|Secondary|Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain|Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145296|NCT00425100|Secondary|Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)|Improvement: positive score change; No improvement: zero or negative score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||participants|||Number
145297|NCT00425100|Secondary|Urgency Perception Scale (UPS)|UPS scores range from 0 (“I am usually not able to hold urine”) to 2 (“I am usually able to finish what I am doing before going to the toilet [without leaking]”).|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145298|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)|Improvement: negative score change; No change: score change=0; Deterioration: positive score change|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||participants|||Number
145299|NCT00425100|Secondary|Patient Perception of Bladder Condition (PPBC) Score|The PPBC score ranges from 1 “no problems at all” to 6 “many severe problems.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145300|NCT00425100|Secondary|Mean Rating on the Urinary Sensation Scale|The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 “no feeling of urgency” to 5 “unable to hold; leak urine.”|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||scores on a scale||Standard Deviation|Mean
145301|NCT00425100|Secondary|Severe Urgency Episodes Per 24 Hours|Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with baseline severe urgency episodes >0 and non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of episodes||Standard Deviation|Mean
145302|NCT00425100|Secondary|Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions (synonymous with the term “nighttime micturitions”) were those recorded in the bedtime section of the bladder diary.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (LOCF). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of nocturnal micturitions||Standard Deviation|Mean
145303|NCT00425100|Primary|Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment|Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.|Week 12|Subjects in the Full Analysis Set (FAS) with non-missing value at Week 12. The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||participants|||Number
145304|NCT00425100|Primary|Mean Number of Urgency Episodes Per 24 Hours|The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) >= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)).The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of episodes||Standard Deviation|Mean
145305|NCT00425100|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment. Restricted to subjects with UUI at baseline >0.||number of episodes||Standard Deviation|Mean
145306|NCT00425100|Primary|Mean Number of Micturition Episodes Per 24 Hours|The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline and Week 12|Subjects in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward (LOCF)). The FAS included all subjects who took at least 1 dose of assigned study drug and contributed data to at least 1 baseline or post-baseline efficacy assessment.||number of episodes||Standard Deviation|Mean
145307|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 2/3|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: ALT, AST, alkaline phosphatase, total bilirubin, GGT, total LDH; renal function tests: BUN, creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||participants|||Number
145853|NCT00422383|Secondary|Peripheral CD19+CD27+ B Cell Count in Cells/µL|Simultaneous surface expression of CD19 and CD27 was assessed by FACS analysis as a marker of memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145308|NCT00425061|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities of Potential Clinical Importance - Stage 1|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils); hepatobiliary biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin, gamma glutamyl transferase (GGT), total lactate dehydrogenase (LDH); renal function tests: blood urea nitrogen (BUN), creatinine, creatinine kinase, uric acid, albumin; electrolytes: sodium, potassium, calcium, magnesium, phosphorus; coagulation: prothrombin time and partial thromboplastin time; glucose: fasting, non-fasting; lipid profile: total cholesterol, triglycerides.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
145309|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
145310|NCT00425061|Other Pre-specified|Number of Participants With Injection Site Reaction - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
145311|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 2/3|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 msec change from baseline and >=220 msec: QRS interval: >=120 msec: QTc interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
145312|NCT00425061|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern - Stage 1|Clinically significant ECG findings included - heart rate: >15 bpm increase from baseline and >=120 bpm, PR interval: >=20 millisecond (msec) change from baseline and >=220 msec: QRS interval: >=120 msec: corrected QT (QTc) interval: >450 msec for males and >470 msec for females.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
145313|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 2/3|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
145314|NCT00425061|Other Pre-specified|Number of Participants With Clinically Important Changes in Physical Findings - Stage 1|Physical examination included examination of general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts, abdomen, external genitalia, extremities, neurological exam, back/spine and lymph nodes.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
145315|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance - Stage 2/3|Criteria for PCI vital sign abnormalities- heart rate: >15 bpm increase from baseline and >=120 bpm, >15 bpm decrease from baseline and <=45 bpm: SBP: >=20 mmHg increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: DBP: of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3.||participants|||Number
145316|NCT00425061|Other Pre-specified|Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance Stage 1|Criteria for potentially clinically important (PCI) vital sign abnormalities- heart rate: greater than (>) 15 beats per minute (bpm) increase from baseline and greater than or equal to (>=) 120 bpm, >15 bpm decrease from baseline and less than or equal to (<=) 45 bpm: systolic blood pressure (SBP): >=20 millimeter of mercury (mmHg) increase from baseline and >=160 mmHg, >=20 mmHg decrease from baseline and <=90 mmHg: diastolic blood pressure (DBP): of >=15 mmHg increase from baseline and >=100 mmHg, >=15 mmHg decrease from baseline and <=50 mmHg, oral temperature <35 or >38.3 degrees centigrade: respiratory rate: <10 or >25 breaths/minute: body weight: >=7% increase or decrease from baseline.|Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1.||participants|||Number
145317|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 2/3||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145318|NCT00425061|Secondary|Serum Interleukin-13 (IL-13) Level - Stage 1||Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145319|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies participants evaluated for this measure at the specified time point for each arm."||log-10 IU/mL||Standard Deviation|Mean
145320|NCT00425061|Secondary|Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1|Log 10-transformed serum total IgE levels were expressed in Log-10 International units/milliliter (IU/mL).|Baseline, Day 28, 56, 84, 112|"mITT population (Stage 1) included all randomized participants who received at least 1 dose of test article in Stage 1. LOCF method was used to impute missing values.'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.n signifies participants evaluated for this measure at the specified time point for each arm."||log-10 IU/mL||Standard Deviation|Mean
145323|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145324|NCT00425061|Secondary|Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1|FEF25-75 is the average expiratory flow over the middle half of the FVC. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145325|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 2/3|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145326|NCT00425061|Secondary|Forced Vital Capacity (FVC) - Stage 1|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 8, 28, 56, 84, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145327|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 2/3|The rescue medication taken for needed symptoms was a SABA inhaler. Albuterol, 90 mcg/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145328|NCT00425061|Secondary|Mean Number of Puffs of Rescue Medication Used - Stage 1|The rescue medication taken for needed symptoms was a short acting beta agonist (SABA) inhaler. Albuterol, 90 microgram (mcg)/puff, was recommended for use.|Day 8, 28, 56, 84, 89, 91, 94, 98, 112|Data for this outcome measure was not analyzed as the study was stopped early and sponsor’s decision to analyze only safety and key efficacy outcomes.|||||
145329|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3||Baseline up to Day 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||percentage of participant|||Number
145330|NCT00425061|Secondary|Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1||Baseline up to Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||percentage of participants|||Number
145331|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of =< 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
145332|NCT00425061|Secondary|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1|ACQ-5 was a 5-item participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing). Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of less than or equal to (=<) 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score greater than or equal to (>=) 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||units on a scale||Standard Deviation|Mean
145333|NCT00425061|Secondary|Change From Baseline in Airway Hyper-reactivity at Day 28 and 112|Airway hyper-reactivity was assessed using provocative concentration 20 (PC20). PC20 was the concentration of methacholine at which participants had 20 percent (%) decrease in FEV1. Results for PC20 were summarized together for all participants who received any dose of IMA-638 and for all participants who received placebo during any stage of the study as per investigator's discretion.|Baseline, Day 28, 112|mITT population included all randomized participants who received at least 1 dose administration of the test article. LOCF method was used to impute missing values. 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||milligram per milliliter (mg/mL)||Standard Deviation|Geometric Mean
145334|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values.||liter||Standard Deviation|Mean
145361|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.||mcg*hr/mL||Full Range|Median
145335|NCT00425061|Secondary|Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Participants performed the test in triplicate at each visit and the best of the 3 values was selected.|Baseline, Day 8, 28, 56, 84, 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. LOCF method was used to impute missing values.||liter||Standard Deviation|Mean
145336|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|"mITT population (Stage 2 and 3) included all randomized participants who received at least 1 dose administration of the test article in Stage 2 and 3. LOCF method was used to impute missing values. n signifies those participants who were evaluated for this measure at the specified time point for each arm."||L/min||Standard Deviation|Mean
145337|NCT00425061|Primary|Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1|The PEFR is a participant’s maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.|Baseline, Day 112|mITT population (Stage 1) included all randomized participants who received at least 1 dose administration of the test article in Stage 1. Last observation carried forward (LOCF) method was used to impute missing values.||liter per minute (L/min)||Standard Deviation|Mean
145338|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 5|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.||µM||Full Range|Mean
145339|NCT00424775|Secondary|Maximum Concentration (Cmax) at Day 4|Maximum Concentration (Cmax) = the maximum plasma concentration of the drug|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.||µM||Full Range|Mean
145340|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 5|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 5|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 5.||µM hr||Full Range|Mean
145341|NCT00424775|Secondary|Area Under the Curve (AUC(0-24 hr)) at Day 4|Area Under the Curve (AUC (0-24 hr)) = Area under the plasma concentration versus time curve (AUC) from time zero to 24 hour.|Day 4|Participants who received vorinostat 300 mg once daily and had Pharmacokinetics Data on Day 4.||µM hr||Full Range|Mean
145342|NCT00424775|Primary|Number of Participants With a Dose Limited Toxicity at First Cycle|Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.|25 Days (first cycle)|All participants who received vorinostat 300 mg once daily.||Participants|||Number
145343|NCT00424762|Secondary|Percentage of Patients Developing New or Worsening Peripheral Edema|clinical evaluation of peripheral edema by physical exam at each study visit by a cardiologist using standard clinical severity scale 0-4, with new/worsening edema defined as any edema in patients with none at baseline, OR increase in severity by 2 or more points in patients with edema at baseline|6 months|||percentage of patients|||Number
145344|NCT00424762|Primary|Peak Oxygen Uptake (VO2)|measurement of peak oxygen uptake (VO2peak) during treadmill exercise, in units of milliliters of oxygen per kilogram of fat-free mass per minute|6 months|completed baseline and end-of-study cardiopulmonary exercise test||ml O2 uptake/kg fat-free mass/minute||Standard Deviation|Mean
145345|NCT00424762|Secondary|Intra-myocardial Triglyceride Content Using in Vivo Magnetic Resonance Spectroscopy at 6 Months|proton magnetic resonance spectroscopy determination of intra-myocardial triglyceride content at baseline and after 6 months, with triglyceride quantified analyzing fat and water signals assuming monoexponential signal decay and expressed as a percentage of fat-to-water (%)|6 months|analysis limited to those with interpretable imaging data at baseline and end of study||percentage of fat-to-water; %||Standard Deviation|Mean
145346|NCT00424749|Primary|Participants With Remission of Renal Disease Activity at 3 Months|Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)|3 months after beginning of remission induction regimen|||participants|||Number
145347|NCT00424749|Secondary|Participants With Normalization of Eosinophil Count at 6 Months|Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.|6 months after beginning of remission induction regimen|||participants|||Number
145348|NCT00424645|Primary|Patient Response Rate (Percentage)|Response rate defined as proportion of patients that clear methotrexate (MTX) at 15 min and 24-hour post infusion of study drug, Glucarpidase (Voraxaze) to total patient number. Serum MTX levels (standard methods and mass spectrometry) at 15 minutes, 24 hours, or daily until MTX clearance defined as serum MTX level <0.1 µmol/L.|Study period 2 years|Analysis was to be per protocol, low accrual and early termination led too few responses for evaluation.|||||
145349|NCT00424632|Secondary|Aurora Gene Somatic Mutations/Amplification and Pathway Genes in Tumor Tissue|Percentage of aurora gene somatic mutations/amplification and pathway genes in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.||percentage of cells|||Number
145362|NCT00424632|Secondary|Time for Maximum Observed Serum Concentration (Tmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set||hours||Full Range|Median
145350|NCT00424632|Secondary|Germ Line Polymorphism of Candidate Genes Targeted by PF-03814735|Percentage of germ line polymorphism cell expression in relation to clinical response. Responses include CR: disappearance of all target lesions; PR: ≥30% decrease in sum of LD of target lesions referencing baseline sum LD; Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of ≥1 new lesions; Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10 (each cycle=21 days)|Data was not summarized as the development of the compound was discontinued.||percentage of cells|||Number
145351|NCT00424632|Secondary|Duration of Response|Duration of responses based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.||months|||Number
145352|NCT00424632|Secondary|Time to Progression|Time to Progression defined as the time from the date of enrollment to the date progressive disease first reported. If tumor progression data included more than 1 date, the first date was to be used. TTP = (first date of tumor progression – date of enrollment + 1). Progressive disease: ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.||months|||Number
145353|NCT00424632|Secondary|Number of Participants With Objective Tumor Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (each cycle=21 days) until disease progression or participant discontinuation; maximum follow-up was from baseline up to 12 cycles|Data was not summarized as the development of the compound was discontinued.||participants|||Number
145354|NCT00424632|Secondary|Target Modulation by Phosphohistone H3 (pH3) Expression in Tumor Tissue (IHC)|pH3 expression is a method to enable the quantification of the proliferative potential of tumor cells. Post-dose tumor tissue sampling occurred after FDG-PET. Biopsies were not to be taken from lesions which were used for PET analysis and were to be taken between 1 and 6 hours after study drug administration. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Schedule A Cycle 1 or Cycle 2 /Day 4 or Day 5, Schedule B Cycle 1/Day 9 or Day 10|Data was not summarized as the development of the compound was discontinued.||percentage of cells||Standard Deviation|Mean
145355|NCT00424632|Secondary|Summary of Tumor Metabolism Assessed by Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)|FTD-PET measured as standardized uptake volume (SUV) values corrected for lean body mass. Change from baseline categorized according to European Organization for Research and Treatment for Cancer (EORTC) criteria: Partial Metabolic Response (PMR): SUV value during treatment <75 percent (%) of baseline value; Progressive Metabolic Disease (PMD): SUV value during treatment >125% of baseline value; Stable Metabolic Disease (SMD): change in SUV value between PMR and PMD. Collected in the expanded MTD cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups).|Baseline (Schedule A or Schedule B Day -7) and Schedule A Cycle 1/Day 3 or Day 4, Schedule B Cycle 1/Day 8 or 9|Data was not summarized as the development of the compound was discontinued.||percent change||Standard Deviation|Mean
145356|NCT00424632|Secondary|Urine Pharmacokinetics|Urine PK for quantification of unchanged PF-03814375 and any identified metabolites. 24-hour urine collection at 8-hour intervals after the morning dose (Schedule [Sch] A Day 4, Sch B Day 9; last sample collected just prior to the morning dose on Sch A Day 5 or Sch B Day 10 in the expanded maximum tolerated dose (MTD) cohort only (≥ 10 participants in Sch A 80 mg and Sch B 50 mg groups). The lower limit of quantification (LLOQ) was 1 nanogram per milliliter (ng/mL). Clinical specimens with concentrations below the LLOQ were to be reported as below the limited of quantification (BLQ) 1 ng/mL.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Data was not summarized as the development of the compound was discontinued.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
145357|NCT00424632|Secondary|Terminal Half-life (t 1/2)|Terminal half-life (serum decay half-life) is the time measured for the serum concentration to decrease by one half.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Half-life (t ½) was not reported for multiple-dose data since the 24-hour sampling period was not long enough to adequately characterize t ½.||hours||Standard Deviation|Mean
145358|NCT00424632|Secondary|Observed Serum Accumulation Ratio (Rac)|Rac was the ratio of Schedule B Cycle 1/Day 9 to Day -5 (Day 9 AUCτ to Day -5 AUCτ).|Schedule B Day-5: pre-dose, 0.5, 1, 2, 4, 6, 10, 24, 32, 48, and 72 hours post-dose, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set. N=number of participants in the indicated population contributing to the mean.||ratio||Geometric Coefficient of Variation|Geometric Mean
145359|NCT00424632|Secondary|Minimum Observed Serum Trough Concentration (Cmin)|Cmin defined as the lowest serum concentration observed during the dosing interval.|Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
145360|NCT00424632|Secondary|Area Under the Serum Concentration Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 24 Hours (AUCτ).||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|PK parameter analysis set||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
145854|NCT00422383|Secondary|Peripheral CD22+ B Cell Count in Cells/µL|Surface expression of CD22 was assessed by FACS analysis as a marker of mature lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145363|NCT00424632|Secondary|Maximum Observed Serum Concentration (Cmax)||Schedule A Cycle 1/Day 4, Schedule B Cycle 1/Day 9: pre-dose, 0.5, 1, 2, 4, 6, 10, and 24 hours post-dose|Pharmacokinetic (PK) parameter analysis set: Enrolled participants who received at least 1 dose of study treatment who had at least 1 of the PK parameters of interest estimated in at least 1 treatment period.||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
145364|NCT00424632|Primary|Number of Participants With First Cycle Dose Limiting Toxicities (DLTs) Graded According to Common Terminology Criteria Adverse Events (CTCAE), Version 3|DLT defined as any of the following during the first cycle of treatment and attributable to PF-03814735: Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or febrile neutropenia (ANC <1000/mm^3, fever ≥38 degrees Celsius; neutropenic infection (ANC <1000/mm^3); Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); ≥Gr 3 nausea, vomiting, or diarrhea, despite optimal antiemetic, anti-diarrheal support; ≥20% decrease in left ventricular ejection fraction compared to baseline; other non-hematological toxicity; any Gr ≥3 adverse event; or failure to recover.|Day 1 up to Day 21 of first cycle|Safety population: Same as the As-treated population, defined as all patients enrolled in the study that received at least 1 dose of the study medication.||participants|||Number
145365|NCT00424619|Secondary|Functional Assessment Using the Two Minute Walk Test (2MWT)After 3 Months|The 2MWT was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended rehabilitation, it was abstracted from their charts. The 2MWT test was given in a carpeted corridor and the subject was instructed to wear regular footwear and to use their customary walking aid. The distance the participant could comfortably walk in two-minutes (without physical assistance) was measured in metres.|3 months|The number of participants who completed the 2WT is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional 2WT test at this time point.||meters||Full Range|Mean
145366|NCT00424619|Primary|Creatinine|Baseline blood samples were drawn in-hospital. In additional creatinine was accessed at baseline.|Baseline|||µmol/L||Standard Deviation|Mean
145367|NCT00424619|Primary|Hemoglobin|Baseline blood samples were drawn in-hospital. In additional hemoglobin was accessed at baseline.|Baseline|||g/L||Standard Deviation|Mean
145368|NCT00424619|Primary|Alkaline Phosphatase|Baseline blood samples were drawn in-hospital. In additional Alkaline Phosphatase was accessed at baseline.|Baseline|||U/L||Standard Deviation|Mean
145369|NCT00424619|Primary|Phosphate|Baseline blood samples were drawn in-hospital. In additional phosphate was accessed at baseline.|Baseline|||mmol/L||Standard Deviation|Mean
145370|NCT00424619|Primary|Calcium|Baseline blood samples were drawn in-hospital. In additional Calcium was accessed at baseline and approximately 4 weeks.|Baseline, 4 weeks|||mmol/L||Standard Deviation|Mean
145371|NCT00424619|Primary|Parathyroid Hormone (PTH)|Baseline blood samples were drawn in-hospital. In additional PTH was accessed at baseline.|Baseline|||pmol/L||Standard Deviation|Mean
145372|NCT00424619|Primary|25-hydroxyvitamin D3 (25-OHD)|Serum 25-hydroxyvitamin D3 (25-OHD) was measured at baseline, at discharge from hospital (approximately 4-weeks), and at a follow-up study visit at approximately 3-months.Baseline and 4-week blood samples were drawn in-hospital; venipunctures performed at 3-months were either in-hospital (if patient remained in acute care or rehabilitation) or at the out-patient clinic visit.Serum 25-OHD was analyzed with the DiaSorin, 25-hydroxyvitamin D radioimmunoassay (Stillwater, Minnesota 55082-0285, U.S.A) at the central laboratory with the exception of 3 patients (data analyzed at other laboratories).|Baseline, 4 weeks and 3 months|Baseline data (n=59) was missing for two participants, and four outliers with 25-OHD taken at 6, 10 or 12 days were not included. 4-week data (n=50) was missing for 13 participants, and two outliers with 25-OHD taken at <13 days were not included. 3-month data (n=47) was missing for 18 participants.||nmol/L||95% Confidence Interval|Mean
145373|NCT00424619|Secondary|Functional Assessment Using the Timed Up and Go (TUG) Test After 3 Months|The Timed Up and Go (TUG) was collected for patients who attended the 3-month clinic appointment by study coordinators or for patients who attended the rehabilitation unit this is routinely collected and was abstracted from chart. The TUG was conducted using a standard armchair and a line marked 3-metres from the chair. Participants were given the following instructions (no physical assistance was given): “Rise from the chair, walk to the line on the floor, turn, return to the chair and sit down again”. Scores are measured as time in seconds to complete the task.|3 months|The number of participants who completed the TUG test is lower than the number of participants who completed the primary outcome at this time point. Not everyone chose to complete the functional TUG test at this time point.||seconds||Full Range|Mean
145374|NCT00424593|Other Pre-specified|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase|Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 through Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.||participant|||Number
145375|NCT00424593|Other Pre-specified|Serious Adverse Events During the Dose-Blind Extension Phase|Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.|Week 13 though Week 54|Number of randomized participants who entered the extension phase. Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported for all patients who entered extension phase regardless of their original randomization group.||participants|||Number
145376|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||kilograms (kg)||Standard Deviation|Mean
145377|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||mm Hg||Standard Deviation|Mean
145378|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate||Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||beats per minute (bpm)||Standard Deviation|Mean
145379|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits only. Last observation carried forward.||micromole per Liter (μmol/L)||Standard Deviation|Mean
145380|NCT00424593|Secondary|Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate||Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value, based on the first values at scheduled visits only. Last observation carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
145381|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145382|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
145383|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.~Absenteeism=(Q2/(Q2+Q4))*100~Presenteeism=(Q5/10)*100~Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100~Activity Impairment=(Q6/10)*100"|Baseline, Week 13, Week 54|"Number of participants currently being paid to work who had a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
145384|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145385|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, Week 13|Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145386|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
145387|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria|Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.||participants|||Number
145388|NCT00424593|Secondary|Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria|Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.|Week 13|Number of randomized participants with non-missing response values.||participants|||Number
145404|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week|Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol.|2 weeks|||Days per week||95% Confidence Interval|Mean
145389|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
145390|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
145391|NCT00424593|Secondary|Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale|24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.|Baseline, Week 13|Number of randomized participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145392|NCT00424593|Secondary|Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13, Week 54|"Number of participants with a baseline and at least one non-missing post-baseline value. Last observation carried forward.~Note: Week 54 was the end of the extension phase and all patients received duloxetine - data are reported per the original randomized group."||units on a scale||Standard Deviation|Mean
145393|NCT00424593|Secondary|Patient's Global Impression of Improvement (PGI-I)|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 13|Number of participants with at least one non-missing post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145394|NCT00424593|Primary|Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of participants with baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
145395|NCT00424554|Secondary|MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days||||||
145396|NCT00424554|Secondary|Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor|No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.|14 days||||||
145397|NCT00424554|Secondary|Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)|An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE.|12 months|||participants|||Number
145398|NCT00424554|Secondary|Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities|"Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).~Grade 4 was defined as life-threatening per CTCAE."|12 months|||participants|||Number
145399|NCT00424554|Primary|MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery|An experimental assay was developed to measure MGMT levels.|14 days|"All participants for which a MGMT activity assay could be~performed"||fmol/mg of proteins||Standard Deviation|Mean
145400|NCT00424528|Secondary|Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Percentage of participants|||Number
145401|NCT00424528|Secondary|Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score|A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Participants|||Number
145402|NCT00424528|Secondary|Transition Dyspnea Index (TDI) Focal Score|TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Units on a scale||Standard Deviation|Mean
145403|NCT00424528|Secondary|Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day|Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period.|2 weeks|||Actuations per day||95% Confidence Interval|Mean
145406|NCT00424528|Secondary|Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing|Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC.|2 weeks|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
145407|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.||Hours||Full Range|Median
145408|NCT00424528|Secondary|Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks|Analyzed from end of dosing to 12 hours.|2 weeks|Total number of subjects in each arm: 76, 80, 78.||Hours||Full Range|Median
145409|NCT00424528|Secondary|Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline|12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.|2 weeks|||Liters||95% Confidence Interval|Mean
145410|NCT00424528|Secondary|Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.|2 weeks|||Percent of predicted FEV1||Standard Deviation|Mean
145411|NCT00424528|Secondary|Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication|Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.|2 weeks|||Liters||Standard Deviation|Mean
145412|NCT00424528|Secondary|Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)|Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.|Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
145413|NCT00424528|Secondary|Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)||Following 2 weeks of dosing|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
145414|NCT00424528|Secondary|Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)||0-12 hours following two weeks of dosing|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
145415|NCT00424528|Primary|Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)||24 hours following two weeks of dosing.|Total number of subjects in each arm: 76, 80, 78||Liters||95% Confidence Interval|Mean
145416|NCT00424515|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1).|The analysis dataset is comprised of treated patients.||months||95% Confidence Interval|Median
145417|NCT00424515|Secondary|Time to Progression|Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.||months||95% Confidence Interval|Median
145418|NCT00424515|Primary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).|The analysis dataset is comprised of treated patients.||participants|||Number
145419|NCT00424502|Secondary|C-Reactive Protein (CRP)|CRP was measured in milligrams per liter (mg/L).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.||mg/L||Standard Deviation|Mean
145420|NCT00424502|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR was measured in mm/hr.|Day 0 and Week 24|All participants who received at least 1 dose of study drug.||mm/hr||Standard Deviation|Mean
145421|NCT00424502|Secondary|Vascular Endothelial Growth Factor (VEGF)|VEGF was measured as picograms per milliliter (pg/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug.||pg/mL||Standard Deviation|Mean
145422|NCT00424502|Secondary|Anti-cyclic Citrullinated Peptide (Anti-CCP)|Anti-CCP measured as absorbance units per milliliter (AU/mL).|Day 0 and Week 24|All participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.||AU/mL||Standard Deviation|Mean
145423|NCT00424502|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Day 0 and Week 24|All enrolled participants. n (number) = number of participants assessed for the specified parameter at a given visit.||units on a scale||Standard Deviation|Mean
154569|NCT00345176|Other Pre-specified|Cognition as Measured by a Telephone Battery|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin, zinc, and beta-carotene on cognitive function|5 years of follow-up||||||
145424|NCT00424502|Primary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 0 and Week 24|All enrolled participants who received at least one dose of study treatment.||units on a scale||Standard Deviation|Mean
145425|NCT00424476|Other Pre-specified|Adverse Events (AE) Overview|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 56 Weeks|||Percentage of participants|||Number
145426|NCT00424476|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40 through 52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day||Percentage of participants|||Number
145427|NCT00424476|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a scale||Standard Error|Mean
145428|NCT00424476|Secondary|Mean Change in Physician's Global Assessment (PGA) at Wk 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a 3-point scale||Standard Error|Mean
145429|NCT00424476|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.||Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Percentage of participants|||Number
145430|NCT00424476|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.||Percentage of participants|||Number
145431|NCT00424398|Secondary|Total Nasal Symptom|Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145432|NCT00424398|Secondary|Eyelid Swelling|Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145433|NCT00424398|Secondary|Ocular Mucus Discharge|Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with OMD Present|||Number
145434|NCT00424398|Secondary|Tearing|Percent of Eyes with Tearing. Scored as absent or present|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Percent of Eyes with Tearing Present|||Number
145435|NCT00424398|Secondary|Nasal Congestion|Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145436|NCT00424398|Secondary|Ear or Palate Pruritus (Itchy Ear or Palate)|Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145437|NCT00424398|Secondary|Nasal Pruritus (Itchy Nose)|Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145438|NCT00424398|Secondary|Rhinorrhea (Runny Nose)|Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
154570|NCT00345176|Other Pre-specified|Incident Cardiovascular Disease|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on cardiovascular disease|5 years of follow-up||||||
145439|NCT00424398|Secondary|Chemosis|Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva|15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145440|NCT00424398|Secondary|Episcleral Redness|Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145441|NCT00424398|Secondary|Ciliary Redness|Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145442|NCT00424398|Primary|Conjunctival Redness|Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145443|NCT00424398|Primary|Ocular Itching|Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub|15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model|||Units on a scale||Standard Deviation|Mean
145444|NCT00424385|Secondary|Time to Disease Progression (TTP)|Medium TTP is 2 months (range 1-5). 10 patients were evaluable for disease progression for these patients occurred between 1-5 months after starting the study. The TTP was calculated per protocol. For radiographic assessment Response Evaluation Criteria in Solid Tumors (RECIST) was used. Complete response = disappearance of all lesions. Partial response (PR)=30% or greater decrease in sum of longest diameter of measureable lesions SD. Lesions have no sufficient decrease for progressive disease and no sufficient increase to meet Progressive Disease (PD). PD more than 20% increase in sum of longest diameter of measurable lesions or 2 or more new bone mets. prostate-specific antigen (PSA) assessment for patients with measurable disease, PSA progression in the absence of measurable disease progression will not be considered progressive disease.|up to 5 cycles, an average of 20 weeks, from the day of first treatment until the date of the last dose of study drug|||months||Full Range|Median
145445|NCT00424385|Secondary|Overall Clinical Benefit|Overall Clinical Benefit was measured as the sum of complete response (CR), partial response (PR), and stable disease (SD).|up to 20 weeks|There were 17 patients enrolled. 10 were evaluable for assessment of overall clinical benefit. 7 were not evaluable due to having received <1 cycle of drug.||percentage of evaluable participants|||Number
145446|NCT00424385|Primary|Number of Patients Experiencing Dose Limiting Toxicities (DLT's)|Eligible patients were enrolled in one of 4 cohorts, where each cohort allowed 3 evaluable patients to be on study, patients withdrawn from treatment for reasons other than toxicity were not considered evaluable. If one of the three evaluable patients experienced a dose limiting toxicity (DLT) the cohort was expanded to 6 evaluable patients. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. If 2 out of six evaluable patients experience a dose limiting toxicity this would show that the Maximum Tolerated Dose (MTD) was the dose from the prior cohort.|up to 20 weeks|Cohort 0: 6 evaluable patients were enrolled. Patients who withdrew for reasons other than toxicity were not considered evaluable for MTD. 1 out of 6 patients had a DLT, therefore Cohort 1 was started. Cohort 1: 2 DLTs were demonstrated from 5 evaluable patients. By definition the Maximum tolerated dose was the dosing schedule used in cohort 0.||participants|||Number
145447|NCT00424372|Primary|Summary of Adverse Events|Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.|52 weeks|Safety population: all subjects who took at least 1 dose of study medication.||subjects|||Number
145448|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale|Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||mm||Standard Deviation|Mean
145449|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity|Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
145450|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score|Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
145451|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score|Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
145452|NCT00424372|Secondary|Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score|Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.|52 weeks|Full Analysis Set, N = Number of subjects assessed||score on scale||Standard Deviation|Mean
145453|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate During the Extension Study|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 24, 36, 48, 60, 72 and 88.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||mm/hr||Standard Deviation|Mean
145454|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels During the Extension Study|HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||mg/L||Standard Deviation|Mean
145455|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score During the Extension Study|The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
145456|NCT00424346|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Extension Study|The physician's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient's global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
145457|NCT00424346|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity During the Extension Study|"The patient's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
145458|NCT00424346|Secondary|Change From Baseline in Patient's Pain Intensity During the Extension Study|The patient's assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
145459|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||tender joints||Standard Deviation|Mean
145460|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count During the Extension Study|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.|The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||swollen joints||Standard Deviation|Mean
145467|NCT00424346|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Deviation|Mean
145461|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at the End of the Extension Study|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, patients were categorized as follows:~Did not attain an ACR20 response;~Attained a 20% but not a 50% response;~Attained a 50% but not a 70% response;~Attained a 70% or greater response.~A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and End of Study (up to 124 weeks)|Extension Study ITT population.||participants|||Number
145462|NCT00424346|Primary|Change From Baseline in Disease Activity Score (DAS) 28 During the Extension Phase|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) in mg/L;~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6"|Baseline and Weeks 24, 72 and 112|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).||scores on a scale||Standard Deviation|Mean
145463|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders During the Extension Phase|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR70 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR70 evaluation data available.||percentage of participants|||Number
145464|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders During the Extension Phase|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR50 evaluation data available.||percentage of participants|||Number
145465|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders During the Extension Phase|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR20 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124|The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR20 evaluation data available.||percentage of participants|||Number
145466|NCT00424346|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F)|"The fatigue subscale of the FACIT is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants respond to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline FACIT-F value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Error|Least Squares Mean
145468|NCT00424346|Secondary|Change From Baseline in Rheumatoid Factor Concentration|Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) that is an indicator of inflammation and rheumatoid arthritis.|Baseline and Weeks 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||kIU/L||Standard Deviation|Mean
145469|NCT00424346|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||mm/hr||Standard Deviation|Mean
145470|NCT00424346|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) in mg/L;~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline DAS28 value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Error|Least Squares Mean
145471|NCT00424346|Secondary|Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels|"HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||mg/L||Standard Error|Least Squares Mean
145472|NCT00424346|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score|"The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from ‘without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by N. Last observation carried forward was utilized."||scores on a scale||Standard Error|Least Squares Mean
145473|NCT00424346|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity|"The physician’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient’s global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by||scores on a scale||Standard Error|Least Squares Mean
145474|NCT00424346|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity|"The patient’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing”. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by||scores on a scale||Standard Error|Least Squares Mean
145475|NCT00424346|Secondary|Change From Baseline in Patient’s Pain Intensity|"The patient’s assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by||scores on a scale||Standard Error|Least Squares Mean
145476|NCT00424346|Secondary|Change From Baseline in Tender 28-joint Count|"The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."||tender joints||Standard Error|Least Squares Mean
145545|NCT00424177|Primary|Number of Participants Who Responded (Platelet Count >=50 Gi/L and >=2x Baseline) to Eltrombopag Treatment in Cycle 2 or Cycle 3 Given Participants Responded in Cycle 1|Complete blood count, platelet count by blood draw|Day 42 of each cycle|Primary Analysis Population: All participants who entered the study, received at least 1 dose of eltrombopag, and responded in Cycle 1||participants|||Number
145477|NCT00424346|Secondary|Change From Baseline in Swollen 28-joint Count|"The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).~Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate."|Baseline and Weeks 2, 4, 8 and 12|"ITT Population, the number of patients included in the analysis at each time point is indicated by N. Last observation carried forward was utilized."||swollen joints||Standard Error|Least Squares Mean
145478|NCT00424346|Secondary|Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at Week 12|"To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, participants were categorized as follows:~Did not attain an ACR20 response;~Attained a 20% but not a 50% response;~Attained a 50% but not a 70% response;~Attained a 70% or greater response.~A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (100 mm visual analog scale [VAS]);~Patient’s global assessment of disease activity (VAS 100 mm);~Physician’s global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP])."|Baseline and Week 12|The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR evaluation. Last observation carried forward was applied for all the component variables.||participants|||Number
145479|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 70 Criteria Responders|"Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered ACR70 non-responders if they failed the ACR70 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR70 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."||percentage of participants|||Number
145480|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|"Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered ACR20 non-responders if they failed the ACR20 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders."|Baseline and Weeks 2, 4, 8 and 12|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR20 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."||percentage of participants|||Number
145481|NCT00424346|Secondary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Weeks 2, 4 and 8|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (VAS 100 mm);~Physician's global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Weeks 2, 4 and 8|"The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables. N indicates the number of patients included at each time point."||percentage of participants|||Number
145482|NCT00424346|Primary|Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Week 12|"Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:~Patient’s pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient’s global assessment of disease activity (VAS 100 mm);~Physician’s global assessment of disease activity (VAS 100 mm);~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);~Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).~Details on each of these components are provided in Outcome Measures 10-16. Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders."|Baseline and Week 12|The intent-to-treat (ITT) population consisted of all patients as randomized that received at least one dose of study drug and had at least one post-baseline efficacy assessment. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables.||percentage of participants|||Number
145483|NCT00424294|Other Pre-specified|Number of Participants With Categorical Vital Signs Data|Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.|Baseline, Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Detailed categorical data was not estimated since summarized continuous data of the vital signs were considered sufficient for the analysis as per investigator’s discretion.||participants|||Number
146691|NCT00414440|Secondary|Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP), at baseline and then months 12 and 24|Baseline, Months 12 and 24|ITT, observed cases||mmHG|Participants|Standard Deviation|Mean
145484|NCT00424294|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett’s Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia’s Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.|Baseline up to Week 12|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
145485|NCT00424294|Other Pre-specified|Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91||Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.||beats per minute||Standard Deviation|Mean
145486|NCT00424294|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.|Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Here, “n” signifies those participants who were evaluable at specified time point for each arm, respectively.||millimeter of mercury (mmHg)||Standard Deviation|Mean
145487|NCT00424294|Secondary|Number of Participants With Clinical Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).|Baseline up to Week 13|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
145488|NCT00424294|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild – AEs does not interfere with participant’s usual function b) moderate – AEs interferes to some extent with participant’s usual function c) severe – AEs interferes significantly with participant’s usual function.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||adverse events|||Number
145489|NCT00424294|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety analysis set is same as FAS. FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
145490|NCT00424294|Secondary|Time to Withdrawal Due to Lack of Efficacy||Baseline up to Week 12|Median time and corresponding confidence interval (CI) were not estimable because only less than half of the participants withdrew from study due to lack of efficacy and hence, were insufficient for the analysis.|||||
145491|NCT00424294|Secondary|Number of Participants Who Withdrew From Study Due to Lack of Efficacy||Baseline up to Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.||participants|||Number
145492|NCT00424294|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12|Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||hour||Standard Deviation|Mean
145493|NCT00424294|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
145794|NCT00422734|Secondary|"Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response"|"Percent of Partners with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable||percentage of partners answering Yes|||Number
145494|NCT00424294|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
145495|NCT00424294|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
145496|NCT00424294|Secondary|Change From Baseline in Physician’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
145497|NCT00424294|Secondary|Change From Baseline in Patient’s Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12|Patient’s global assessment of arthritic condition assessed all the ways participants’ illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||units on a scale||Standard Deviation|Mean
145498|NCT00424294|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12|Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||mm||Standard Deviation|Mean
145499|NCT00424294|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||swollen joints||Standard Deviation|Mean
145500|NCT00424294|Secondary|Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12|Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.|Baseline, Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug.Here,“n” signifies those participants who were evaluable at specified time point for each arm,respectively. For descriptive data,observed cases were reported and for statistical data,LOCF imputation method was used.||tender/painful joints||Standard Deviation|Mean
145501|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.||percentage of participants|||Number
145731|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Mental Function Impairment Scale (MENFIS)|MENFIS was used to assess patient cognitive and psychiatric function, and evaluates core symptoms of dementia including cognitive, motivational and emotional aspects. The total score ranges from 0 to 78. The higher the score, the greater the functional deficit. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
145502|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8, 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.||percentage of participants|||Number
145503|NCT00424294|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 1, 2, 4, 8|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using LOCF method.||percentage of participants|||Number
145504|NCT00424294|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|FAS was an intent-to-treat analysis set including all participants randomized to treatment who had taken at least 1 dose of study drug. Missing values were imputed using last observation carried forward (LOCF) method.||percentage of participants|||Number
145505|NCT00424268|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
145506|NCT00424268|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
145507|NCT00424268|Secondary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|24 weeks treatment period|ITT analysis||exacerbations per patient per year||95% Confidence Interval|Mean
145508|NCT00424268|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
145509|NCT00424268|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
145510|NCT00424255|Secondary|Number of Participants With the Indicated Worst-case On-therapy Left Ventricular Ejection Fraction (LVEF) Change From Baseline|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart with each contraction. LVEF was assessed using echocardiogram (ECHO: a test of the action of the heart using ultrasound waves to produce a visual display, for the diagnosis or monitoring of heart disease ) and multigated acqusition scans (MUGA scan: a noninvasive diagnostic test used to evaluate the pumping function of the ventricles). Data from the ECHO and MUGA scans were combined, and the absolute change from Baseline (Abs) data are presented according to the following categories: No change or any increase, 0-<10% decrease, 10-19% decrease, >=20% decrease, >=10% decrease and >=the Lower Limit of Normal (LLN), >=10% decrease and below LLN, >=20% decrease and >=LLN, or >=20% decrease and below LLN. The relative percent change from Baseline (Rel) data are presented according to the following categories: >=20% decrease and >=LLN and >=20% decrease and below LLN.|From the end of the CRT until the last follow-up visit (average of 141 study weeks)|Safety Population. Only those participants available at the specified time points were analyzed.||Participants|||Number
145511|NCT00424255|Secondary|Number of Participants With the Indicated Biomarker Expression Status|Biomarkers (which influence clinical response) assessed from tumor tissues included P16, Human Papilloma virus (HPV), and Epidermal Growth Factor Receptor (EGFR)/Epidermal Growth Factor Receptor 1 (ErbB1). Biomarker expression is presented as positive, negative, or unknown. Participants in the ErbB1-positive category include those with results of positive or strongly positive.|Baseline (BL; within 8 weeks prior to randomization [Day 1]) (up to Study Week 1)|ITT Population||Participants|||Number
146166|NCT00420290|Secondary|Serum Prealbumin|Prealbumin is a sensitive laboratory assay for serum levels of prealbumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||mg/dl||Standard Deviation|Mean
145512|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|Change from Baseline in quality of life status was assessed using the EQ-5D scale, a 5-item health status measure and a visual analog rating scale. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The EQ-5D is a generic measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. The EQ-5D covers health status in 5 domains (3 questions each): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each item is scored as follows: 1, no problems; 2, some moderate problems; 3, extreme problems. The possible EQ-5D index utility values range from 0.594 to 1, and the thermometer score ranges from 0 to 100. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
145513|NCT00424255|Secondary|Change From Baseline in Quality of Life Status as Assessed by the Functional Assessement of Cancer Therapy-Head and Neck (FACT-H&N) Questionnaire|Change from Baseline in quality of life status was assessed using the FACT-H&N questionnaire, which is designed to measure multidimensional quality of life in participants with head and neck cancer. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The FACT-H&N questionnaire contains 39 items (27 general questions and 12 head and neck cancer-specific items) covering 4 dimensions and 1 subscale: physical well-being, social/family well-being, emotional well-being, functional well-being, and a head and neck cancer subscale. Possible subscale scores range from 0 to 36. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.|From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)|Safety Population. Only those participants who had a Baseline and post-Baseline score at the specified time points were analyzed.||scores on a scale||Standard Error|Least Squares Mean
145514|NCT00424255|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used by doctors and researchers to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Baseline (BL; within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population||Participants|||Number
145515|NCT00424255|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded at Baseline, at the end of the CRT, at Maintenance Week 56, at withdrawal from IP, and at anytime post-baseline. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. The study investigator determined if an abnormal ECG finding was CS or NCS.|Baseline (BL; within 8 weeks prior to randomization [Day 1]), End of CRT, Maintenance Week 56, Withdrawal from IP, and at any time Post-Baseline (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
145516|NCT00424255|Secondary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Kilograms||Standard Deviation|Mean
145517|NCT00424255|Secondary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Degrees Centigrade||Standard Deviation|Mean
145518|NCT00424255|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate (HR) was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Beats per minute||Standard Deviation|Mean
145855|NCT00422383|Secondary|Peripheral CD20+ B Cell Count in Cells/µL|Surface expression of CD20 was assessed by FACS analysis as a marker of mature and memory B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|The safety analysis population (SAP) = ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145519|NCT00424255|Secondary|Change From Baseline in Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from investigational product (IP; up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Millimeters of mercury (mmHg)||Standard Deviation|Mean
145520|NCT00424255|Secondary|Number of Participants With On-therapy and Follow-up Late Radiation Morbidity Events|Late radiation morbidity event data are summarized as the number of participants with late radiation morbidity events per system organ class (SOC). Late radiation effects are defined as those that first occur 90 days or more after the initiation of radiation therapy.|From 180 days after completion of radiation until the last follow-up/withdrawal visit (average of 64 study weeks)|Safety Population||Participants|||Number
145521|NCT00424255|Secondary|Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the NCI CTC version 3.0 toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated hematological parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. Hematology parameter included: hemoglobin, total neutrophils (TN), platelet count (PC), and White Blood Cell (WBC) count.|From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
145522|NCT00424255|Secondary|Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit|Data are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI CTC version 3.0) toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated chemistry parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: albumin, alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transeferase (AST), total bilirubin (TB), calcium, carbon dioxide content/bicarbonate (CO2/HCO3), creatinine, glucose, potassium, and sodium. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit.|From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
145523|NCT00424255|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of non-serious AEs occurring at a frequency threshold of 5% and SAEs.|From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks)|Safety Population||Participants|||Number
145524|NCT00424255|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment administered during the study. The mean duration of treatment is calculated as the number of days between the start of treatment and the end of treatment inclusive (i.e., treatment stop date minus treatment start date + 1). Participants were counted in a treatment phase (monotherapy, chemoradiotherapy, and maintenance) if they had received any dose in that phase. Participants randomized to placebo who received >=1 dose of lapatinib in error were included in the lapatinib arm.|From randomization until end of 1year maintenance treatment (average of 63 study weeks)|Safety Population (SP): all participants (par.) who were randomized and took >=1 dose of study medication. Only par. available at the specified time points were analyzed (represented by n=X, X in the category titles). Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.||Weeks||Standard Deviation|Mean
145525|NCT00424255|Secondary|Number of Participants With a Second Primary Tumor|Participants who developed a second primary tumor at the time of the first recurrence or within 28 days of the first recurrence were measured. The criteria for a second primary tumor are as follows: a distinct lesion separated from the primary tumor site by >2 centimeters of normal epithelium; or a new cancer with different histology; or any cancer, regardless of site, occurring >=3 years after initial treatment. Participants with baseline disease were included in the denominator when calculating the percentage.|From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks)|ITT Population||Participants|||Number
145526|NCT00424255|Secondary|Time to Distant Relapse (TTDR)|TTDR is defined as the time from randomization until the first occurrence that distant relapse is documented. Distant relapse is defined as clear evidence of distant metastases (lung, bone, brain, etc.). Metastasis is defined as the spread of a cancer from one organ or part to another non-adjacent organ or part. All other events prior to a distant relapse were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks)|ITT Population||Months||95% Confidence Interval|Median
145527|NCT00424255|Secondary|Time to Locoregional Recurrence (TTLR)|TTLR is defined as the time from randomization until the first occurrence that local and/or regional recurrence is documented or the date of censor. Local relapse is defined as recurrent cancer in the primary tumor bed not clearly attributable to a second primary neoplasm. Regional relapse is defined as recurrent cancer in the neck not clearly attributable to a second primary neoplasm. All other events prior to locoregional recurrence were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.|From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks)|ITT Population||Months||95% Confidence Interval|Median
145528|NCT00424255|Secondary|Disease Specific Survival (DSS)|DSS is defined as the time from randomization until death due to head and neck cancer. Participants whose death was not related to the disease under study were treated as competing risks at the time death occured. Participants who were alive were censored at the time of their last visit.|From randomization until death due to head and neck cancer (average of 131 study weeks)|ITT Population||Months||95% Confidence Interval|Median
145529|NCT00424255|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. For participants who did not die, the time to death was censored at the time of last visit/contact.|From randomization until death due to any cause (average of 131 study weeks)|ITT Population||Months||95% Confidence Interval|Median
145530|NCT00424255|Primary|Disease Free Survival (DFS)|DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation. For participants whose disease did not recur or who did not die, DFS was censored at the time of the last independently assessed radiological scan (where initiation of alternative anti-cancer therapy had not commenced). Participants who missed two or more consecutive disease assessments were censored at the last assessment prior to the missed assessments. Participants considered to have malignant disease at Baseline were censored at the time of randomization.|From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, irrespective of whether they actually received study medication||Months||95% Confidence Interval|Median
145531|NCT00424190|Secondary|Assess Safety|Comparisons of the number of participants with Adverse Events|First dose of study drug through TOC visit||||||
145532|NCT00424190|Secondary|Microbiological Reinfection or Recurrence at the LFU Visit||21 to 35 days after the last dose of study drug||||||
145533|NCT00424190|Secondary|Clinical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug||||||
145534|NCT00424190|Secondary|Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug||||||
145535|NCT00424190|Secondary|Clinical Response at the End of Therapy (EOT) Visit||Last day of study drug administration||||||
145536|NCT00424190|Secondary|Microbiological Success Rate at the TOC Visit||8-15 days after last dose of study drug||||||
145537|NCT00424190|Primary|Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population||8-15 days after last dose of study drug||||||
145538|NCT00424190|Primary|Clinical Cure Rate at Test of Cure (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting AE; requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome"|8-15 days after the end of treatment|MITT (Modified Intent to Treat) - Any randomized subjects that received any amount of study drug||participants|||Number
145539|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the ITP Bleeding Score|ITP Bleeding Score: Grade 0 = no bleeding, Grade 1 = mild bleeding, Grade 2 = severe bleeding|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1||participants|||Number
145540|NCT00424177|Secondary|Number of Participants With the Indicated Bleeding Signs and Symptoms Using the World Health Organization Bleeding Scale|World health Organization (WHO) Bleeding Scale Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross blood loss, Grade 4 = debilitating blood loss.|Baseline, on-treatment visits (Weeks 1-6), off-treatment visits (Weeks 1-4)|Participants who responded in Cycle 1||participants|||Number
145541|NCT00424177|Secondary|Change in Participants Anti-platelet Antibody Levels From Baseline Through Follow-up|Change in participants' anti-platelet antibody levels was measured as the number of samples positive for at least 1 glycoprotein from baseline to follow-up. Serum glycoprotein-specific antigens: GPIIb/IIIa, Ib/IX, and Ia/IIa|Up to 1 year|Safety Population: any participant who received at least 1 dose of study medication||participants|||Number
145542|NCT00424177|Secondary|Number of Participants Who Required Rescue Medication|New idiopathic thrombocytopenic purpura (ITP) medication, increase dose of a concomitant ITP medication from baseline, platelet transfusion, and/or splenectomy|Up to 3 cycles of treatment including follow-up visits following last dose of eltrombopag|ITT Population||participants|||Number
145543|NCT00424177|Secondary|Changes in Participants' Platelet Counts During 3 Cycles of Treatment|Changes from baseline, during on-therapy periods of a cycle, during off-therapy periods of a cycle, and within 4 weeks of permanent discontinuation of eltrombopag treatment.|Up to 1 year|Intent-to-Treat (ITT) Population: All participants who were dispensed study medication||Gi/L||Full Range|Median
145544|NCT00424177|Secondary|Number of Participants Who Responded (Platelet Count Greater Than or Equal to 50 Gi/L and at Least 2x Baseline) for at Least 80 Percent of Their On-therapy Assessments During Weeks 2-6.|CBC, platelet counts|Up to 42 days of dosing|Cycle 1 responders||participants|||Number
145546|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 Mar 2008; up to 51 months|Intent to Treat population includes all participants who were randomized to study drug.||weeks||95% Confidence Interval|Median
145547|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 02 March 2008; up to 51 months|Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.||weeks||95% Confidence Interval|Median
145548|NCT00424047|Secondary|Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale|The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.|Randomization to cut off date of 03 August 2005; up to 24 months|Intent to Treat includes all participants who were randomized to study drug; a total of six ECOG scores were missing at the time of the Aug 2005 cut-off.||weeks||95% Confidence Interval|Median
145549|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 02 March 2008; up to 51 months|Intent to treat included all participants who were randomized.||weeks||95% Confidence Interval|Median
145550|NCT00424047|Post-Hoc|Kaplan-Meier Estimate of Duration of Response|Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.|Up to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized to study drug.||weeks||95% Confidence Interval|Median
145551|NCT00424047|Secondary|Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)|Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).|Up to unblinding data cut off of 03 August 2005; up to 24 months|Analysis not performed due to an insufficient number of participants with SRE||participants|||Number
145552|NCT00424047|Secondary|Number of Participants With Adverse Events (AE)|"An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.~The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death."|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months|The safety population includes all participants who received at least one dose of study drug regimen||participants|||Number
145553|NCT00424047|Secondary|Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to data cut-off of 02 Mar 2008; up to 51 months|Intent to Treat Population includes all participants who were randomized||percentage of participants|||Number
145564|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
149296|NCT00394654|Secondary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
145554|NCT00424047|Secondary|Summary of Myeloma Response Rates Based on Best Response Assessment|Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.|Randomization to 03 August 2005; up to 24 months|Intent to Treat Population includes all participants who were randomized||percentage of participants|||Number
145555|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 02 March 2008; up to 51 months|Intent to Treat population includes all participants who were randomized.||weeks||95% Confidence Interval|Median
145556|NCT00424047|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|Randomization to data cut off of 03 August 2005; up to 24 months|Intent to Treat population includes all participants who were randomized.||weeks||95% Confidence Interval|Median
145557|NCT00424047|Primary|Kaplan-Meier Estimate of Time to Tumor Progression (TTP)|Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.|From randomization up to cut-off date of 03 August 2005; up to 24 months|Intent to treat included all participants who were randomized.||weeks||95% Confidence Interval|Median
145558|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.||Participants|||Number
145559|NCT00424021|Primary|Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.||Participants|||Number
145560|NCT00424021|Secondary|Long-term Survival|Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.|Week 24 (AMB-220-E baseline) to Week 329.3|The AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study) was evaluated during the AMB-220-E study period.||Probability (%)|||Number
145561|NCT00424021|Secondary|Failure-free Treatment Status|Failure-free treatment status was defined as the time from initiation of active treatment to the first occurrence of death, lung transplantation, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the NCT00046319 study) was evaluated during the NCT00046319 and AMB-220-E study periods.||Probability (%)|||Number
145562|NCT00424021|Secondary|Time to Clinical Worsening of PAH|Clinical worsening of PAH was defined as death, lung transplantation, hospitalization for PAH, atrial septostomy, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Sildenafil, a type 5 phosphodiesterase (PDE-5) inhibitor, had not received regulatory approval for the treatment of PAH until late in the conduct of AMB 220 and AMB 220-E, and did not count toward clinical worsening. Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.|Week 0 (NCT00046319 baseline) to Week 360|The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the AMB-220 study) was evaluated during the NCT00046319 and AMB-220-E study periods.||Probability (%)|||Number
145563|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
151880|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|3 month follow-up|||units on a scale||Standard Deviation|Mean
145565|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
145566|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
145567|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])|The SGA was determined using a visual-analog scale. Subjects were asked the question, “How are you feeling today?” and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented “very poor” and 100 represented “excellent.”|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).||Units on a Scale||Standard Deviation|Mean
145568|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|180 weeks (Week 24 of NCT00046319 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
145569|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|132 weeks (Week 24 of NCT00046319 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
145570|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|84 weeks (Week 24 of NCT00046319 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
145571|NCT00424021|Secondary|Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E|Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|24 weeks (Week 24 [baseline of AMB-220-E] to Week 48)|||Participants|||Number
145572|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Participants|||Number
145573|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
145574|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
145575|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
145576|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
145577|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])|Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Units on a Scale||Standard Deviation|Mean
145578|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|180 weeks (Week 24 to Week 204)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
145579|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|132 weeks (Week 24 to Week 156)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
145580|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|84 weeks (Week 24 to Week 108)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
145581|NCT00424021|Secondary|Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48)|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|24 weeks (Week 24 to Week 48)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
145582|NCT00424021|Secondary|Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])|The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).|Week 24 (AMB-220-E baseline)|Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.||Meters||Standard Deviation|Mean
145610|NCT00423878|Secondary|Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)||Measured at Month 6|2 participants who never took assigned study medication were excluded.||participants|||Number
145583|NCT00424021|Primary|Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure|The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.|Week 24 (AMB-220-E baseline) to Week 334|The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.||Participants|||Number
145584|NCT00424008|Secondary|The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period.|For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline proportion of symptom-free days/nights as a covariate."||Proportion of symptom-free days/nights||Standard Deviation|Least Squares Mean
145585|NCT00424008|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint|The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period.|Baseline to Week 12|"Efficacy analyses were based on randomized subjects with Baseline and any postbaseline data (intent-to-treat principle).~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline ACQ score as a covariate."||Scores on a scale||Standard Deviation|Least Squares Mean
145586|NCT00424008|Secondary|Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1|PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval.|Baseline to 5 minutes post-dose on Day 1|"Participants with data at Day One 5 minutes post-dose.~The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate."||Liters||Standard Deviation|Least Squares Mean
145587|NCT00424008|Primary|The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1)||Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle). The standard deviation is pooled. Least Squares Mean scores are obtained from an analysis of covariance model correcting for treatment, site effects, and the Baseline FEV1 (liters) as a covariate.||Liter x hour||Standard Deviation|Least Squares Mean
145588|NCT00423891|Secondary|Number of Participants With Electrolyte Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO) for chloride. Milliequivalents per liter (mEq/L); Grade (Gr). Chloride high (mEq/L): Gr1: 113-<117; Gr2: 117-<121; Gr3: 121-125; Gr4: >125. Potassium low (mEq/L): Gr1: 3.0-3.4; Gr2: 2.5-2.9; Gr3:2.0-<2.4; Gr4: <2.0. Potassium high: Gr1; 5.6- <6.0; Gr2: 6.1-<6.5; Gr3: 6.6-7.0; Gr4: >7.0. Sodium high (mEq/L): Gr1; 146-<150; Gr2: 151-<154; Gr3: 155-<159; Gr4: >=160.|Day 1 Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).||participants|||Number
145589|NCT00423891|Secondary|Number of Participants With Chemistry Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: DAIDS Version 1.0 and modified World Health Organization (WHO). Grade (Gr). ALT: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0 *ULN; Gr3: 5.1-10.0*ULN; Gr4:>10.0*ULN. Aspartate aminotransferase (AST): Gr1: 1.25-<2.5*ULN; Gr2:2.6-<5.0*ULN; Gr 3: 5.1-10.0*ULN; Gr4>10.0*ULN. Alkaline phosphatase: Gr1:1.25-<2.5*ULN; Gr2: 2.6-<5.0*ULN; Gr3: 5.1-10.0*ULN; Gr4: >10.0*ULN. Lipase: Gr1:1.1-<1.5*ULN;Gr2:1.6-<3.0*ULN; Gr3: 3.1-5.0*ULN; Gr4: >5.0*ULN. Creatinine: Gr1: 1.1-1.3*ULN; Gr2: 1.4-<1.8*ULN; Gr3: 1.9 - <3.4*ULN; Gr4: >=3.5*ULN. Glucose mg/dL (high): Gr1:110-<125 (Fasting)/116-<160;Gr2:126-<250 (F)/161-<250; Gr3: 251-500; Gr4: >500.Glucose (low): Gr1: 55-64; Gr2: 40 - <54; Gr3: 30-39; Gr4: <30 mg/dL.|Day 1 to Week 120|Participants who received at least one dose of study drug, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).||participants|||Number
145590|NCT00423891|Secondary|Number of Participants With Hematology Laboratory Abnormalities (Grades 1 - 4) - On Treatment - Treated Participants|Toxicity Scale: Division of AIDs (DAIDS) grades Version 1.0. Upper limit of normal (ULN); lower limit of normal (LLN); Cells per Liter (c/L); cells per microliter (c/µL); grams per deciliter (g/dL); milliequivalents per liter (mEq/L); cells per microliter (c/µL): Grade (Gr). Hemoglobin g/dL: Gr1:10.0-10.9;Gr2: 9.0-9.9; Gr3:7.0-8.9; Gr4: <7.0. International normalization ratio (INR): Gr1:1.1-<1.5*ULN; Gr2: 1.6-<2.0*ULN; Gr3: 2.1-3.0*ULN;Gr4: >3.0*ULN. Neutrophils/bands c/µL: Gr1;1.0-1.3*10^3; Gr2: 0.75-0.99*10^3; Gr 3: 0.50-0.749*10^3; Gr4: <0.5*10^3.|Day 1 to Week 120|Participants who received at least 1 dose of study therapy, and had a measurement during the on-treatment period (i.e., after the first day of study therapy through 5 days after the last dose of study therapy).||participants|||Number
145591|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Without HBeAg Seroconversion, Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HBeAb. The method used for the detection of HBeAg/Ab serologies was the DiaSorin enzyme immunoassay kit.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145592|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL, Plus HBeAg Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN. HBe seroconversion was determination of presence of HBeAb and loss of HBeAg. The method used for the detection of HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145593|NCT00423891|Secondary|Number of Participants With a Combination of ALT Normalization and HBV DNA Less Than 50 IU/mL Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy. Normalization in ALT= ALT ≤ 1.0*ULN.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145594|NCT00423891|Secondary|Number of Participants With HBV DNA by PCR Categories (Non-Completer=Failure) at Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline, Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145595|NCT00423891|Secondary|Alanine Aminotransferase (ALT) Normalization From Baseline Through Week 48 (Non-Completer=Failure) in Treated Participants|Normalization in ALT= ALT ≤ 1.0*upper limit of normal (ULN). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145596|NCT00423891|Secondary|Mean Log10 Change From Baseline in HBV DNA Using Roche COBAS TaqMan - HPS Through Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. HBV DNA log10 changes from baseline were summarized over time.|Baseline to Week 48|Participants who received at least one dose of study drug, and had a measurement at baseline and at the specific analysis week.||IU/mL||Standard Error|Mean
145597|NCT00423891|Secondary|Number of Participants Who Had a Protocol Defined Response (PDR) Through Week 48 (Non-Completer=Failure) in Treated Participants|PDR was defined as confirmed HBV DNA < 50 IU/mL plus confirmed HBeAg seroconversion on 2 sequential measurements at least 14 days apart. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145598|NCT00423891|Secondary|Number of Participants With HB s Antigen (HBsAg) Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants|HB s Ag seroconversion: loss of HBsAg (HBsAg negative) and presence of HB s antibodies (HBsAb). The method used for the detection of HBsAg seroconversion was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145599|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Quantification (LLQ) for the Roche COBAS TaqMan - HPS Assay (Non-Completer=Failure) Through Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLQ = 29 IU/mL. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145600|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than Lower Limit of Detection (LLD) for the Roche COBAS TaqMan - HPS Assay (Non-Completer=Failure) at Week 48 in Treated Participants|Hepatitis B virus DNA by PCR was measured using the Roche COBAS TaqMan - HPS assay and was reported in IU/mL. LLD = 6 IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145636|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at FW 12|"Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
145601|NCT00423891|Primary|Number of Participants With Serious Adverse Events (SAE) and Discontinuations Due to Adverse Events (AEs) - On Treatment|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 was used.|Day 1 to Week 120|All participants who received at least one dose of study drug. On-treatment period began on the first day of study therapy and ended 5 days after the last dose of study therapy.||participants|||Number
145602|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen Seroconversion Through Week 48 (Non-Completer=Failure) in Treated Participants|HBe seroconversion: loss of HBeAg (HBeAg negative) with positive HB e antibodies (HBeAb), ie both the presence of HBeAb and the absence of HBeAg. The method used for the detection HBeAg seroconversion was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline through Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145603|NCT00423891|Secondary|Number of Participants With Hepatitis B s Antigen (HBsAg) Loss Through Week 48 (Non-Completer=Failure) in Treated Participants|HBsAg loss: HBsAg negative. The method used for detection of HBsAg was the ADVIA Centaur iImmunoassay system. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145604|NCT00423891|Secondary|Number of Participants With Hepatitis B e Antigen (HBeAg) Loss Through Week 48 (Non-Completer=Failure) in Treated Participants|HBeAg loss: HBeAg negative. The method used for the detection of HBe Ag was the DiaSorin - Anti HBe enzyme immunoassay kit. Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145605|NCT00423891|Secondary|Number of Participants With HBV DNA Less Than 50 IU/mL Through Week 48 (Non-Completer=Failure) in Treated Participants|Hepatitis B virus DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS TaqMan - high pure system (HPS) assay and was reported in international units per milliliter (IU/mL). Baseline was the last value measured prior to or on the date of the first dose of study therapy.|Baseline to Week 48|The intent-to-treat method of Non-Completer = Failure was used in which the number of participants analyzed was all treated participants, and participants who had missing data at the analysis week were considered failures.||participants|||Number
145606|NCT00423891|Primary|Mean Apparent Total Body Clearance (CLT/F) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|CLT/F was calculated by dividing the dose of ETV by AUC(TAU) of ETV and was measured in liters per hour (L/h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|At 2 weeks|Participants in Groups A and B who received study drug and had PK assessment.||L/h||Standard Deviation|Mean
145607|NCT00423891|Primary|Mean Area Under the Concentration-Time Curve in One Dosing Interval [AUC(TAU)] of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Area under the Curve (AUC) was derived from plasma concentration of ETV versus time. AUC(TAU) was calculated by log- and linear trapezoidal summations, TAU = 24 hours, and was measured in nanograms*hours per milliliter (ng*h/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
145608|NCT00423891|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) in LVD-naive and LVD-experienced Participants, by Age Cohort|Tmax was derived from plasma concentration of ETV versus time and measured in hours (h). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Age categories presented below: participants age as of first day of dosing. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.||h||Full Range|Median
145609|NCT00423891|Primary|Mean Maximum Observed Plasma Concentration (Cmax) and Mean Trough Observed Plasma Concentration (Cmin) of Entecavir in LVD-naive and LVD-experienced Participants, by Age Cohort|Cmax and Cmin were derived from plasma concentration of ETV versus time and measured in nanograms per milliliters (ng/mL). Blood samples were obtained before study drug administration and at 0.5, 1, 2, 4, 8, and 24 hours after study drug administration on Day 14 (+/- 4 days) for the PK assessment. Plasma samples were analyzed for ETV with a validated method using liquid chromatography-tandem mass spectrometry detection. Note: PK parameters were summarized for only Groups A and B. PK assessment was optional for Group C participants (NA-experienced participants who were included with the September 2011 country-specific protocol amendment). No Group C participants chose to participate in the PK assessment.|Day 14|Participants in Groups A and B who received study drug and had PK assessment.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
145611|NCT00423878|Primary|Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks|Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.|24 weeks|The primary efficacy analysis was conducted on the efficacy evaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one post-baseline efficacy assessment.||mg/dL non-HDL cholesterol||Standard Error|Least Squares Mean
145612|NCT00423852|Primary|Maximum Tolerated Dose of Ifosfamide||4 years|||mg/m2|||Number
145613|NCT00423852|Primary|Response|"Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary)~Complete Response (CR): A complete response is defined as one of the following:~Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy).~Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks.~Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks."|2 year|||participants|||Number
145614|NCT00423813|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14|||Percentage of Participants|||Number
145615|NCT00423800|Secondary|Number of Participants With a Virological Relapse|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).~Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment."|24 weeks following completion of 24 or 48 weeks of therapy|ITT population that completed the study.||Participants|||Number
145616|NCT00423800|Primary|Number of Participants With a Sustained Virologic Response|"Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.~Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder."|24 weeks following completion of 24 or 48 weeks of therapy|||Participants|||Number
145617|NCT00423735|Secondary|PFS Distribution|The Kaplan-Meier method will be used.|6 months||||||
145618|NCT00423735|Secondary|Objective Response Rates [Complete Response (CR), Partial Response (PR), Stable Disease, Progression]||6 months||||||
145619|NCT00423735|Secondary|Rates of Treatment Adverse Events||6 months||||||
145620|NCT00423735|Secondary|Overall Survival Distribution|The Kaplan-Meier method will be used.|6 months||||||
145621|NCT00423735|Secondary|Number of Patients Achieving Objective Response (Partial or Complete Response) OR 6-month Progression-free Survival (6mPFS)|Study design and efficacy determination uses the hybrid endpoint of 6mPFS or complete/partial response of any duration prior to or at 6 months. Null hypothesis = 11%; alternative hypothesis = 25%. Simon’s minmax 2-stage design was used with type I and type II error both set at 10%. Stage 1 and 1B: If 2 or fewer patients were alive and progression-free at 6 months or achieved complete/partial response, then there would be no further accrual and the alternative hypothesis would be rejected. Otherwise accrual would continue to a total of 50 analyzable patients to address the primary endpoint.|6 months|Eligible patients who started protocol treatment.||participants|||Number
145622|NCT00423735|Primary|Number of Patients Achieving 6-month Progression-free Survival (6mPFS)|This study utilized a two-stage phase II design (Stage 1B and 2). The primary endpoint of 6-month progression-free survival (6mPFS) would be assessed based on the patients combined from 1B and 2 if the study continued to Stage 2. Null hypothesis = 11%; alternative hypothesis = 25%. Simon's minmax 2-stage design was used with type I and type II error both set at 10%. If the first stage met its criteria (see secondary outcome measure), then accrual would continue, otherwise there would be no further accrual and the alternative hypothesis would be rejected. Following Stage 2 accrual completion and 6 months of follow-up, if 9 or more patients were alive without progression by 6 months, the null hypothesis would be rejected in favor of the alternative.|6 months|Eligible patients who started protocol treatment.||participants|||Number
145623|NCT00423722|Secondary|Change in Dehydration as Measured by Dehydration Assessment Scale|Dehydration was assessed by using the Dehydration Assessment Scale on the basis of three physical findings, moisture on the mucous membranes of the mouth (0=moist, 1=somewhat dry, 2=dry), axillary moisture (0=moist, 1=dry) and sunkenness of the eyes (0=normal, 1=slight sunken, 2=sunken). These signs are selected due to their significant correlations with biological dehydration, as previously confirmed by elderly patients. The dehydration score (range 0-7) is calculated as the total of these 3 scores, a higher score indicates a higher level of dehydration. The reported value was the mean of average change in patients' scores per group.|Baseline to Day 7|||units on a scale||Standard Deviation|Mean
145652|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145624|NCT00423722|Secondary|Reduced Symptom Burden (From Baseline to 7 Days Post Infusion)|Secondary outcomes included delirium, quality of life, and overall survival. The Nursing delirium screening scale (NuDESC) was used to assess delirium. NuDESC is a validated observational instrument conducted by research staff based on input from family caregivers. Five symptoms (disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation) are each given a score from 0 to 2, for a possible total score of 10. A higher NuDESC score indicates increased symptoms of delirium. It was observed a trend for lesser decline (delirium) in the hydration group, and significant worsening of night-time NuDESC scores in the placebo group.|Baseline to Day 7 (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)|||units on a scale||Inter-Quartile Range|Mean
145625|NCT00423722|Secondary|Change in Quality of Life and Fatigue as Measured by FACIT-F and FACT-G From Baseline to Day 7|"Change between Day 7 to Baseline in FACIT-F (Functional Assessment of Chronic illness Therapy-Fatigue) & FACT-G (Functional Assessment of Cancer Therapy-General) scores. Participants rate quality of life using FACT-G consisting of 33 questions with 5 domains assessing physical and social, emotional & functional well being & relationship with physician, remaining 5 assess extent to which each domain affects overall quality of life on 5-point scale from 0 (not at all) to 4 (very much); total score obtained by summing individual subscale scores (0-132). FACIT-F consists of 13 items where participants rate intensity of fatigue & its related symptoms on a scale of 0-4 from 0 not at all to 4 very much. The responses to FACIT fatigue questionnaire are each measured on 4‐point Likert scale with total score ranges from 0 to 52. High scores represent less fatigue. Reported is the mean change of the summed value of all reported scores for the FACT-G or the FACIT-F from baseline to Day 7."|Baseline to Day 7|||units on a scale||Standard Deviation|Mean
145626|NCT00423722|Secondary|Reduced Symptom Burden as Measured by RASS, MDAS and UMRS|"Participants rated delirium, quality of life, and overall survival using Richmond agitation sedition scale (RASS) where +4 is Combative to -5 is Unarousable; Memorial delirium assessment scale (MDAS), a ten-item, clinician-rated scale from 0 (none) to 3 (severe) for severity of delirium, for a total range of 0-30; and Unified Myoclonus Rating Scale (UMRS) 5-functional scores rated 0 to 4, for a total range of 0-20 where higher scores indicate more severe involuntary movements. Higher scores indicate worse outcomes for each scale, i.e. RASS more agitation, MDAS more delirium and UMRS more severe involuntary movements. The mean represents change in combined participant daily scores for each scale between Baseline and Day 4 assessments then separately Day 7 assessments. Reported value is mean of average change in patients' scores per group. Reported values reflect changes from baseline, either median decreases (less than 0), no change (0) or increases (greater than 0)."|Baseline to Day 7|||units on a scale||Inter-Quartile Range|Median
145627|NCT00423722|Primary|Participant Reduced Symptom Burden|Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.|From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion)|||units on a scale||Standard Deviation|Mean
145628|NCT00423683|Secondary|Resolution of PE||3 years or until death|33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites||percentage of PE sites|Participants||Number
145629|NCT00423683|Secondary|Resolution of DVT||3 years or until death|33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites||percentage of DVT sites|Participants||Number
145630|NCT00423683|Secondary|Overall Survival||3 years or until death|||days||95% Confidence Interval|Median
145631|NCT00423683|Primary|Adverse Outcomes|Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs|3 years or until death|||percentage of participants|||Number
145632|NCT00423670|Secondary|Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR|"Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL."|At FW 24 up to EOF and at 72 weeks post randomization|Participants who achieved SVR.||Participants|||Number
145633|NCT00423670|Secondary|Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR|"Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At FW 12 and FW 24 up to EOF|Participants with undetectable HCV-RNA at FW 12.||Participants|||Number
145634|NCT00423670|Secondary|Number of Participants With an Early Virologic Response (EVR) That Achieved SVR|"Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~if he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|At TW 12, and at FW 24 up to EOF|Participants with an early virologic response (EVR).||Participants|||Number
145635|NCT00423670|Secondary|Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization|"Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|72 weeks post randomization|||Participants|||Number
145959|NCT00421889|Secondary|Duration of Response|Defined as interval from the time criteria for CR or PR are met, until the first date that recurrent or progressive disease is objectively documented.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.||days||Full Range|Median
145637|NCT00423670|Secondary|Number of Participants With SVR Based on Duration of Boceprevir Treatment|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
145638|NCT00423670|Secondary|Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin|"Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL."|From FW 24 up to EOF|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
145639|NCT00423670|Primary|Number of Participants With Sustained Virologic Response (SVR)|"Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.~Participants missing data at FW 24 were considered to achieve SVR if~he/she had undetectable HCV-RNA at FW 12 or later~he/she returned later to the study center and had undetectable HCV-RNA.~HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).~A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR."|From follow-up week (FW) 24 up to end of follow-up (EOF)|Intent-to-Treat (ITT) population: All randomized participants who received at least one dose of any study medication (PegIntron, ribavirin, or boceprevir).||Participants|||Number
145640|NCT00423657|Secondary|To Evaluate Safety||first study drug dose through TOC||||||
145641|NCT00423657|Secondary|To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit||21-35 days after last dose of study drug||||||
145642|NCT00423657|Secondary|To Evaluate Clnical Relapse at the Late Follow Up (LFU) Visit||21 to 35 days after the last dose of study drug||||||
145643|NCT00423657|Secondary|To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit||8-15 days after last dose of study drug||||||
145644|NCT00423657|Secondary|To Evaluate the Clinical Response at the End of Therapy (EOT) Visit||last day of study drug administration||||||
145645|NCT00423657|Secondary|To Evaluate the Microbiological Success Rate at the TOC Visit||8-15 days after the last dose of study drug||||||
145646|NCT00423657|Primary|The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the CE Populations.||8-15 days after last dose of study drug||||||
145647|NCT00423657|Primary|Clinical Cure Rate at Test of Cure (TOC) (MITT Population)|"Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.~Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting AE; requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.~Indeterminate: Inability to determine an outcome"|8-15 days after last dose of study drug administration|MITT (Modified Intent to Treat) - all subjects that received any amount of study drug||participants|||Number
145648|NCT00423605|Primary|Number of Subjects Reporting Adverse Events|Number of subjects reporting adverse events.|Treatment Period (38 weeks)|||Participants|||Number
145649|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145650|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145651|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145795|NCT00422734|Secondary|"Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response"|"Percent of subjects with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)"|12 weeks|all randomized participants having post-baseline data measurement on this variable||percentage of subjects answering Yes|||Number
145653|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145654|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145655|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145656|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145657|NCT00423592|Secondary|Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145658|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145659|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class|Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Participants|||Number
145660|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise|Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||Units on a scale||Standard Deviation|Mean
145661|NCT00423592|Secondary|A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD)|The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline to Week 12|The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.||meters||Standard Deviation|Mean
145831|NCT00422383|Secondary|Percentage of Participants With Positive Recall Antigen Antibody Titers|A positive titer result to recall antigens was defined as a serum antibody level equal to or above the following protective levels: tetanus toxoid ≥ 0.1 IU/mL, influenza A > 12 U/mL, influenza B > 12 U/mL, and streptococcus (S.) pneumococcus ≥ 1.0 mg/L.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
145662|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.||participants|||Number
145663|NCT00423592|Secondary|The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.||participants|||Number
145664|NCT00423592|Primary|The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug.|The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.|Week 12|The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.||Participants|||Number
145665|NCT00423579|Primary|Change in Low-density-lipoprotein Cholesterol (LDL-C) at 6 Weeks|Percentage change in LDL C from baseline to endpoint after 6 weeks of treatment.|Baseline and 6 weeks|Intent-to-treat population only.||percentage change||Standard Deviation|Mean
145666|NCT00423488|Primary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint, After 6 Weeks of Treatment||6 weeks of treatment (from Baseline to Endpoint)|Intent-to-treat population only.||percentage change||Standard Deviation|Mean
145667|NCT00423449|Primary|Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease|"Maximum tolerated dose (MTD) was defined as the highest dose level in which fewer than 2 patients among the first 6 enrolled experience a DLT (as defined in Outcome Measure 1) during the first cycle of treatment.~The MTD was 400 mg for up to 10 days in 21-day cycles."|every 21 days (every cycle), up to 126 days (6 cycles)|||mg|||Number
145668|NCT00423449|Secondary|Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability)|"An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)|||Participants|||Number
145669|NCT00423449|Secondary|Number of Participants With Clinical Adverse Experiences (Safety and Tolerability)|"An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.~The AEs could have been any grade from 1 to 5 in severity (mild, moderate, severe, life-threatening, death, respectively)."|every 21 days (every cycle), up to 126 days (6 cycles)|||Participants|||Number
145670|NCT00423449|Primary|Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin|DLT = any Common Terminology Criteria for Adverse Events Grade 3/4 drug related non-hematologic toxicity EXCEPT Grade 3 nausea/vomiting responsive to therapy, Grade 3 Fatigue responsive to management, transient electrolyte disorders that were corrected, any Grade 4 drug related hematologic toxicity EXCEPT lymphopenia/neutropenia, unless the neutropenia was febrile and/or was an infection requiring treatment, OR Any Grade 4 neutropenia lasting >=7 days, failure of absolute neutrophil count or platelets to recover, or any drug-related AE that led to a dose reduction of >=1 study drugs.|every 21 days (every cycle), up to 126 days (6 cycles)|||Participants|||Number
145671|NCT00423436|Primary|Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments|Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.|Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)|Analysis was per protocol. Due to attrition, data from 61 participants were analyzed at end of first chemotherapy cycle and from 27 participants at the end of the study.||Ratio of alerts/number of assessments|Participants||Number
145672|NCT00423358|Secondary|Short Form 36 Survey|12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function|1 Year|Intent to treat analysis||units from 0 (worst) to 100 (best)||95% Confidence Interval|Mean
145673|NCT00423358|Secondary|Bone Mineral Density|one year change in mean total hip BMD|1 Year|Intent to treat analysis||g/cm2||Standard Deviation|Mean
145674|NCT00423358|Primary|Parathyroid Hormone Level|Serum parathyroid hormone level|1 Year|Subject data were analyzed using the intent to treat approach.||pg/mL||Standard Deviation|Mean
145675|NCT00423332|Secondary|Best Objective Tumour Response|Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).|Baseline, Week 12 and every 8 weeks thereafter or until progression.|For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a ‘best response’ summary.||Participants|||Number
145676|NCT00423332|Secondary|Objective Tumour Response at 12 Weeks|Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.|Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.|||Participants|||Number
145677|NCT00423332|Secondary|Progression Free Survival|Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Treatment period up to 2nd data cut-off of 8th March 2009.|Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised to placebo. All patients irrespective of whether they had a 12 week scan are included in this analysis. At week 12 placebo patients were able to switch to cediranib.||Months||Full Range|Median
145678|NCT00423332|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period up to 2nd data cut-off of 8th March 2009|"For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)).~13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off."||Months||Inter-Quartile Range|Median
145679|NCT00423332|Secondary|Best Percentage Change From Baseline in Tumour Size During the Study|Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions|Treatment period up to Week 12 visit date for last patient in (LPI)|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data.||Percentage change from baseline||Standard Deviation|Mean
145680|NCT00423332|Primary|Percentage Change From Baseline in Tumour Size at 12 Weeks|Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100|Baseline to Week 12|For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data||Percentage change from baseline||Standard Deviation|Mean
145681|NCT00423319|Secondary|Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. All suspected events were reported by investigator. Acute MI=the presence of a clinical situation (eg, abnormal history, physical examination, new electrocardiogram changes) suggestive of an MI and at least 1 of the following: elevated creatine kinase (CK)-MB or troponin T or troponin I ≥2*upper limit of normal (ULN); if CK-MB or troponin values not available, total CK ≥2*ULN; or new significant (≥0.04 sec) Q waves in ≥2 contiguous leads. Stroke=a new focal neurologic deficit of sudden onset lasting at least 24 hours that was not due to a readily identifiable nonvascular cause. Adjudication classified each reported stroke as primary hemorrhagic, nonhemorrhagic, infarction with hemorrhagic conversion, or unknown type. Thrombocytopenia=after 3 days as drop in platelet count to <100,000/mm^3 for patients with a baseline value >150,000/mm^3 or a >50% decline, if the baseline value was ≤150,000/mm^3.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants who received at least 1 dose of study drug||Percent of events/patients evaluated||95% Confidence Interval|Number
145682|NCT00423319|Secondary|Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period|Treatment guidelines were provided for jaundice and elevated results of liver function tests.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145683|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Glucose, fasting (mg/dL): <.8*LLN or >1.5*ULN, or if preRx <LLN use <.8*preRx or >ULN if preRx >ULN use >2*preRx or <LLN; protein, total (g/L): If missing preRx use ≥2, or if value ≥4 or preRx =0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; creatine kinase (U/L): >5*ULN; uric acid (mg/dL): >.5* ULN, or if preRx >ULN use >2*preRx; blood, urine: If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx=1 use ≥3, or if preRx =2 or 3 use ≥4; glucose, urine : If missing preRx use ≥2, or if value ≥4, or if preRx=0 or .5 use ≥2, or if preRx=1 use ≥3, or if preRx=2 or 3 use ≥4; RBC, urine (hpf): If missing preRx use ≥2, or if value ≥4, or if preRx=0 or 0.5 use ≥2, or if preRx dose= 1 use ≥3, or if preRx=2 or 3 use ≥4; WBC, urine (h): If missing preRx use ≥2, or if value ≥4, or if preRx =0 or .5 use ≥2, or if preRx =1 use ≥3, or if preRx=2 or 3 use ≥4.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145684|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. Alanine aminotransferase (ALT) (U/L): >3 *ULN: alkaline phosphatase (ALP) (U/L): >2* ULN; aspartate aminotransferase (ASP) (U/L): >3 *ULN; bilirubin, direct (mg/dL): >2*ULN; bilirubin, total (mg/dL): >2*ULN; BUN (mg/dL): >2*ULN; creatinine (mg/dL): >1.5*ULN; calcium (mg/dL): < 0.8*LLN or >1.2 *ULN, or if preRx <LLN use <0.75* preRx or >ULN if preRx >ULN use > 1.25*preRx or <LLN; chloride (mEq/L): <0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or <LLN; bicarbonate (mEq/L): < 0.75* LLN or >1.25*ULN, or if preRx <LLN use <0.75*preRx or >ULN if preRx >ULN use >1.25*preRx or <LLN; potassium (mEq/L): < 0.9*LLN or >1.1*ULN, or if preRx <LLN use <0.9*preRx or >ULN if preRx >ULN use >1.1* preRx or < LLN; sodium (mEq/L): <0.95* LLN or >1.05×ULN, or if preRx <LLN use <0.95* predose or >ULN if preRx >ULN use >1.05 *preRx or < LLN.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145685|NCT00423319|Secondary|Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period|preRx=predose; LLN=lower limit of normal; ULN=upper limit of normal. MA criteria: Hemoglobin: >2 g/dL decrease from preRx or value ≤ 8 g/dL; hematocrit (%): <0.75*preRx; platelet count (*10^9 cells/L): <100,000/mm^3; erythrocytes (*10^6 cells/μL): <0.75*preRx level; leukocytes (*10^3 cells/μL): < 0.75*LLN or >1.25*ULN, or if preRx LLN use < 0.8*preRx or >ULN if preRx >ULN use >1.2*preRx or <LLN; basophils (*10^3 cells/μL): >400/mm^3; eosinophils (*10^3 cells/μL): > 0.75*10^3 cells/μL; lymphocytes (*10^3 cells/μL): >0.75*10^3 cells/μL; monocytes (*10^3 cells/μL): >2000/mm^3; neutrophils (*10^3 cells/μL): <1.0;|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145686|NCT00423319|Secondary|Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period|Neurologic events were based on Medical Dictionary for Regulatory Activities search categories.For new or worsening events that were not related to the site of surgery, additional information was collected on a specific form. In addition, neurology consultation was to be obtained for these patients.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145687|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145688|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145689|NCT00423319|Secondary|Number of Participants With a Bleeding-related Adverse Event During the Treatment Period|All suspected bleeding events were to be reported by the investigator as either an adverse event or serious adverse event or and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood. All acute clinically overt bleeding events were adjudicated by the ICAC as a major bleeding event or a clinically relevant nonmajor bleeding event; suspected minor bleeding events were not sent for adjudication.|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
145690|NCT00423319|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All suspected bleeding events were to be reported by the investigator as either an AE or SAE and adjudicated by the Independent Central Adjudication Committee (ICAC). Definitions of bleeding outcomes: Acute clinically overt bleeding =new onset, visible bleeding, or signs or symptoms suggestive of bleeding with confirmatory imaging techniques that could detect the presence of blood.|First dose of study drug (presurgery) through 30 days after the last dose of study drug|All participants who received at least 1 dose of study medication||Participants|||Number
145704|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.~Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months|||Participants|||Number
145850|NCT00422383|Secondary|Change From BL in Peripheral CD3+ T Cell Count|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145691|NCT00423319|Secondary|Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Major bleeding event defined as a bleeding event that was 1) Acute clinically overt bleeding accompanied by at least 1 of the following: decrease in hemoglobin of ≥ 2 g/dL over a 24-hour period, transfusion of ≥2 units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intra-spinal, intraocular, pericardial, an operated joint and requires reoperation or intervention, intramuscular with compartment syndrome, or retroperitoneal; 2) Fatal. CRNM was defined as acute clinically overt bleeding that did not satisfy the criteria for a major bleeding event and met at least 1 of the following: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, or hemoptysis. Minor bleeding was defined as an acute clinically overt bleeding event that did not meet the criteria for major bleeding or a CRNM. Fatal bleeding event was defined as bleeding that was the primary|First dose of study drug (presurgery) through 2 days after the last dose of study drug|All participants who received at least 1 dose of study drug||Percentage of events/patients evaluted||95% Confidence Interval|Number
145692|NCT00423319|Secondary|Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period|VTE=venous thromboembolic event; VTE-related death=combination of fatal or nonfatal PE and symptomatic or asymptomatic DVT. Event rate=Number of events divided by the number of patients evaluated.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All participants randomized to treatment||Percentage of events/patients evaluated|||Number
145693|NCT00423319|Secondary|Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. Each patient was categorized as having no proximal DVT, having proximal DVT, being nonevaluable for proximal DVT, having no distal DVT, having distal DVT, or being nonevaluable for distal DVT. Adjudication criteria were: Normal=All deep veins were visualized, and there was no intraluminal filling defect (ILFD). ILFD=An area of reduced, or absent filling, at least partially surrounded with contrast medium in ≥ 2 projections or a lack of filling in a vessel in which there was a cut-off that had the configuration of a thrombus. Indeterminate=A lack of filling of a region of the deep vein system, proximal or distal, without the presence of an ILFD elsewhere in the same region. Not Done=A venography was not performed. Proximal DVT was found if any of the proximal veins had an ILFD. Pulmonary embolism was radiographically (angiography, V/Q scan, computed tomography) determined.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|Randomized participants with either an adjudicated event or an adjudicated evaluable bilateral venogram||Percentage of events/patients evaluated||95% Confidence Interval|Number
145694|NCT00423319|Primary|Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period|Event rate=Number of events divided by the number of patients evaluated. A mandatory bilateral ascending contrast venogram was to be obtained on Day 35 (± 3). Patients with confirmed symptomatic DVT at any time, or asymptomatic DVT upon venography, were to receive treatment for DVT according to the investigator’s standard of care. Signs and symptoms suggestive of VTE included, but were not limited to: 1) lower extremity DVT: erythema, warmth, pain, swelling, tenderness; and 2) PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended Treatment Period started on day of randomization and, for patients who received treatment, ended at the later of 2 days after last dose of study drug or 38 days after the first dose (presurgery) of study drug. For randomized patients who did not receive study drug, the period ended 38 days after randomization.|Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose|All randomized participants who, during the Intended Treatment Period, had an adjudicated and evaluable bilateral venogram, had an adjudicated venous thromboembolic event, or died of any cause.||Percentage of events/patients evaluated||95% Confidence Interval|Number
145695|NCT00423293|Secondary|Efficacy of Treatment, in Terms of Locoregional Failure, Disease-free Survival, Time to Colostomy, Colostomy-free Survival, and Overall Survival||From registration to date of failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
145696|NCT00423293|Secondary|Radiotherapy Treatment Time||From start to end of radiation therapy||||||
145697|NCT00423293|Secondary|Clinical Complete Response Rate||From registration to 8 and 12 weeks after treatment completion||||||
145698|NCT00423293|Secondary|Adverse Event Rates as Defined by CTCAE v 3.0 Within 90 Days From the Start of Study Treatment||From the start of treatment to 90 days||||||
145699|NCT00423293|Secondary|Reproducibility of the Intensity-modulated Radiation Therapy Technique||IMRT planning and dosing data is centrally reviewed for quality assurance||||||
145700|NCT00423293|Primary|Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) ≥ Grade 2 as Defined by CTCAE v3.0 (Common Terminology Criteria for Adverse Events)||From the start of treatment to 90 days|Eligible patients with adverse event information.||percentage of participants||95% Confidence Interval|Number
145701|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B||12 months|||Participants|||Number
145702|NCT00423267|Secondary|Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A||12 months|||Participants|||Number
145703|NCT00423267|Secondary|Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months|||Participants|||Number
145851|NCT00422383|Secondary|Peripheral CD3+ T Cell Count in Cells/µL|Surface expression of CD3 was assessed by FACS analysis as a marker of absolute T lymphocyte count. The normal range of CD3+ T cells was defined as 723-2737 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145705|NCT00423267|Secondary|Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A|Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.|12 months|||Participants|||Number
145706|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months|||Participants|||Number
145707|NCT00423267|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A|Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.|12 months|||Participants|||Number
145708|NCT00423267|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A|"Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.~Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication."|12 months|||Participants|||Number
145709|NCT00423189|Secondary|Safety of Combination Therapy With Verteporfin PDT and ITV Ranibizumab|Safety of combination therapy with verteporfin PDT and ITV ranibizumab was not determined due to lack of efficacy.|1 Year||||||
145710|NCT00423189|Secondary|Choroidal Perfusion as Assessed by ICG Angiography at 1, 2, 3, 6, and 12 Months|Choroidal perfusion as assessed by ICG angiography at 1, 2, 3, 6, and 12 months was not determined due to lack of efficacy|1 Year||||||
145711|NCT00423189|Secondary|OCT 3 Macular Thickness Improvement (Baseline-1month, 2months, 3months, 6months &12 Months)|OCT 3 macular thickness improvement at Baseline-1month, 2months, 3months, 6months &12 months was not determined due to lack of efficacy.|1 Year||||||
145712|NCT00423189|Secondary|Number of Intravitreal Injections With Ranibizumab Needed by Patients at 12 Months|Number of intravitreal injections with ranibizumab needed by patients at 12 months was not determined due to lack of efficacy.|1 Year|not determined due to lack of efficacy|||||
145713|NCT00423189|Primary|Best-corrected ETDRS Visual Acuity at 6 Months and 12 Months Only Time Points (Gain or Loss of >15 Letters at 12 Months)|Visual Acuity was measured by ETDRS by certified refractionists in certified lanes at 12 months. Visual Acuity was not measured by ETDRS at 6 months.|1 Year|As per subjects participated||participants|||Number
145714|NCT00423176|Primary|Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline|A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.||Percentage of opacification||Standard Deviation|Mean
145715|NCT00423176|Primary|Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.|The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.|29-day Treatment Period and 2-week no-treatment Follow-up Period.|Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.||Units on a scale||Standard Deviation|Mean
145716|NCT00423150|Primary|Tumor Responses (Complete and Partial Response)|"Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first|"Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants).~Complete response is defined as disappearance of all target lesions.~Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."||Participants|||Number
145717|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)|BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician's intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) populationincluded all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.||Units on a scale||Standard Deviation|Mean
145730|NCT00423085|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
145718|NCT00423098|Secondary|Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)|SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.|From Baseline to week 4, week 12 and week 24|Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.||Units on a scale||Standard Deviation|Mean
145719|NCT00423098|Secondary|Number of Patients With Treatment Failure|Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.|12 Weeks and 24 Weeks|Safety Population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||participants|||Number
145720|NCT00423098|Secondary|Number of Patients With Adverse Events and Infections|Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||participants|||Number
145721|NCT00423098|Secondary|Duration of Exposure to Study Medication|The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.|24 weeks|Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||days||Standard Deviation|Mean
145722|NCT00423098|Secondary|Number of Patients With Moderate to Severe Flares|A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)|12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||participants|||Number
145723|NCT00423098|Secondary|Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)|Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.|12 Weeks and 24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||mg/kg||Standard Deviation|Mean
145724|NCT00423098|Secondary|Number of Patients With Partial Remission|Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.|Baseline to 12 and 24 weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||Participants|||Number
145725|NCT00423098|Secondary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.|12 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||participants|||Number
145726|NCT00423098|Primary|Number of Patients With Complete Remission|Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.|24 Weeks|Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.||Participants|||Number
145727|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Modified Crichton Scale|The Modified Crichton Scale includes a total of seven items evaluated in eight grades that assess basic activities of daily living, communication functions, psychiatric symptoms and quality of life; the total score can range from 0 to 56, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.||units on a scale||Standard Deviation|Mean
145728|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living. The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in activities of daily living while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward.||units on a scale||Standard Deviation|Mean
145729|NCT00423085|Secondary|Extension Phase: Change From Extension Phase Baseline to End of Extension in Mini-Mental State Examination (MMSE)|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. This outcome measured the change in MMSE from the beginning of the open-label extension phase through to Week 52 of the extension phase.|Extension Phase Baseline and Week 52 of extension phase|Intent-to-treat population utilizing last observation carried forward. This population includes all patients who received at least one dose of open-label study medication and had at least one efficacy assessment on treatment in the open-label extension Phase.||units on a scale||Standard Deviation|Mean
154604|NCT00344305|Secondary|Number of Subjects Reporting Serious Adverse Events and Significant New Medical Conditions Through 180 Days Post Vaccination||Days 0-180 after vaccination|Safety population||participants|||Number
145732|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|BEHAVE-AD was used to assess patient behavior and psychiatric symptoms. It covers symptoms in seven categories: paranoid and delusional ideation, hallucinations, activity disturbances, diurnal rhythm disturbances, aggressiveness, affective disorders and anxieties, and phobias. Caregivers rate behavioral symptoms on a 0–3 scale. The total score can range from 0 to 66, with a lower score indicating better function. A negative change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
145733|NCT00423085|Secondary|Change From Baseline in CIBIC Plus-J Score Disability Assessment for Dementia (DAD)|The Disability Assessment for Dementia (DAD) was used to assess levels of difficulty in activities of daily living (ADL). The DAD is administered through an interview with the caregiver. A total score is obtained by adding the rating for each question and converting this to a total score out of 100 (%). Higher scores represent less disability in ADL while lower scores indicate more dysfunction. A positive change score indicates an improvement from baseline.|Baseline and Week 24|Intent-to-treat population. Only patients with a valid baseline and post-baseline score were included.||units on a scale||Standard Deviation|Mean
145734|NCT00423085|Primary|Overall Clinical Rating of Change From Baseline to Week 24 Measured by the Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"The overall clinical rating of change from baseline to week 24 measured by the 7-point CIBIC plus-J scale. The Clinician's Interview-Based Impression of Change plus Caregiver Input consists of 3 subscales: Disability Assessment of Dementia Scale, Behavioral Pathology in Alzheimer's Disease Rating Scale and Mental Function Impairment Scale, as well as the Clinician's Global Impression of Change (CGIC). Participants are scored according to the following:~Markedly improved~Moderately improved~Minimally improved~Unchanged~Minimally worse~Moderately worse~Markedly worse"|Baseline and Week 24|Intent-to-treat population utilizing LOCF.||Participants|||Number
145735|NCT00423085|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline and Week 24|The Intent-to-treat population: This population includes all randomized patients who received at least one dose of study drug and had at least a baseline and any post-baseline assessment on treatment (i.e. not more than 2 days after the last known date of study drug) for one of the primary efficacy variables. LOCF was utilized.||units on a scale||Standard Deviation|Mean
145736|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAE(s) was not assessed.~Note: SAEs were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
145737|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
145738|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145739|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145740|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145741|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjetcs|||Number
145960|NCT00421889|Secondary|Time to Response|Time to response (RECIST) was assessed as the interval between the first dates of treatment until the first notation of response.|Throughout study|Includes patients with response, i.e. 15 patients in Part B, 0 patients in Part C, and 4 patients in Part D. Not done for Part A.||days||Full Range|Median
145742|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. Intensity of SAEs was not assessed.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145743|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|"NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.~Note: NOCD and MSC cases were unblinded at the Month 60 analysis."|Up to Month 60|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
145744|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
145745|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 36|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145746|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 24|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145747|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 18|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145748|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up To Month 12|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145749|NCT00423046|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 7|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||Subjects|||Number
145750|NCT00423046|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 3 AE = AE that prevented normal activity. Related AE = AE assessed by the investigator as causally related to the study vaccination.|During the 30-day period (Day 0-29) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
145852|NCT00422383|Secondary|Peripheral CD19+CD27 Negative (-) B Cell Count in Cells/µL|Surface expression of CD19 in the absence of CD27 expression was assessed by FACS analysis as a marker of naive B lymphocyte count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145751|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
145752|NCT00423046|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. All solicited local symptoms were assessed as related to study vaccination.|During the 7-day period (Day 0-6) following vaccination|Analyses were performed on subjects with available data within the Total Vaccinated cohort, which included subjects with at least one vaccine administration.||subjects|||Number
145753|NCT00423046|Secondary|Number of Subjects Completing the 3-dose Vaccination Schedule||Up to Month 7|The number of subjects completing the 3-dose vaccination schedule was defined as the number of subjects who received the 3 active doses (placebo administrations are not reflected).||subjects|||Number
145754|NCT00423046|Secondary|Titers of HPV-16 IgG and HPV-18 IgG (by ELISA) in Cervico-vaginal Secretions (CVS)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 7, 12, 18, 24, 36 and 48|Analyses were done on those subjects from the ATP cohort for immunogenicity for whom CVS samples with less than 200 erythrocytes per microliter were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
145755|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific B-cells Per Million B Cells|HPV-16 and HPV-18 Specific Memory B Cells were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay and expressed as geometric mean, minimum and maximum values of specific B-cells per million of cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group in subjects with detectable B-cells (>0) at defined time points, who were HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific B-cell negative at baseline from a subset of the ATP cohort for immunogenicity.||cells per million B-cells||Full Range|Geometric Mean
145756|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD8 Cells Producing at Least 2 Different Cytokines Per Million of CD8 T Cells|"Data were expressed as geometric mean, minimum and maximum values of specific CD8 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD8 T-cells.~Analyses for further time points were not performed, as there was no response at these time points."|At Month 7, 12 and 18|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 200 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.||cells per million CD8 T-cells||Full Range|Geometric Mean
145757|NCT00423046|Secondary|Number of HPV-16 and HVP-18 Specific CD4 Cells Producing at Least 2 Different Cytokines Per Million of CD4 T Cells|Number of cells were expressed as geometric mean, minimum and maximum values of specific CD4 cells producing at least 2 cytokines (CD40 Ligand, Interleukin-2, Tumor Necrosis Factor Alpha or Interferon-gamma) per million of CD4 T-cells.|At Month 7, 12, 18, 24, 36 and 48|Results are presented by age group for subjects HPV-16/18 seronegative (by PSV neutralizing assay), DNA negative and HPV-16/18 specific T-cell negative (i.e., with < 500 cells/million cells at baseline) from a subset of the ATP cohort for immunogenicity.||cells per million CD4 T-cells||Full Range|Geometric Mean
145758|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
145759|NCT00423046|Secondary|Number of Subjects With Antibody Titers to Other Oncogenic HPV Types Greater Than or Equal to a Cut-off Value, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Other oncogenic types include HPV-31 and HPV-45. Cut-off values assessed were greater than or equal 59 EL.U/mL in the sera of subjects seronegative before vaccination.|At Month 6, 7, 12, 18, 24, 36 and 48|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||subjects|||Number
145760|NCT00423046|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||EL.U/mL||95% Confidence Interval|Geometric Mean
145761|NCT00423046|Secondary|Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibody Titers Above Cut-off Values, Measured by Enzyme-linked Immunosorbent Assay (ELISA)|Cut-off values assessed were greater than or equal to 8 ELISA units per milliliter (EL.U/mL) for HPV-16 and greater than or equal to 7 EL.U/mL for HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the ATP cohort for immunogenicity who were seronegative (by ELISA) and DNA negative for the corresponding type at baseline.||subjects|||Number
145762|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Human Papilloma Virus 16 (Anti-HPV-16) and Human Papilloma Virus 18 (Anti-HPV-18) Greater Than or Equal to the Cut-off Value|The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both HPV-16 and HPV-18.|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||subjects|||Number
145763|NCT00423046|Secondary|Titers of Antibodies to Other Oncogenic HPV Types Measured by Neutralization Assay|Other Oncogenic Types include HPV-31 and HPV-45. Titers were measured by neutralization assay and are given as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity with titer greater than or equal to 40 ED50 and who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||titer||95% Confidence Interval|Geometric Mean
145764|NCT00423046|Secondary|Number of Subjects With Antibody Titers (Neutralizing Assay) Against Other Oncongenic HPV Types Greater Than or Equal to the Cut-off Value|Other oncogenic HPV types include HPV-31 and HPV-45. The titer value (=serum dilution giving a 50 percent reduction of the signal compared to a control without serum) used as the cut-off for seroconversion was 40 for both other oncogenic types HPV-31 and HPV-45.|At Month 7|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||subjects|||Number
145765|NCT00423046|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|"Titers are given as Geometric Mean Titers (GMTs). Titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.~Data for Month 7 on subjects aged 18 to 26 years are given in the outcome above as a primary outcome measure."|At Month 6, 7, 12, 18, 24, 36, 48 and 60|Analysis was performed by age group on subjects from the According-to-Protocol (ATP) cohort for immunogenicity who were seronegative by Pseudovirion neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||Titer||95% Confidence Interval|Geometric Mean
145766|NCT00423046|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibodies|Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.|At Month 7|Analysis was performed on subjects from the According-to-Protocol (ATP) cohort for immunogenicity aged 18 to 26 years and who were seronegative by Pseudovirion (PSV) neutralizing assay and deoxyribonucleic acid (DNA) negative for the corresponding type at baseline.||titer||95% Confidence Interval|Geometric Mean
145767|NCT00422942|Primary|Change From Baseline in Absolute B Cell CD19+ Counts in Peripheral Blood|The change from baseline in absolute B cell (CD19+) count at each visit calculated as (B cell count at visit minus B cell count at baseline) for peripheral blood.|Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145768|NCT00422942|Secondary|Change From Baseline in Joint Space Narrowing (JSN) Score|Changes from baseline in modified Sharp radiographic JSN score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145769|NCT00422942|Secondary|Change From Baseline in Erosion Score|Changes from baseline in modified Sharp radiographic erosion score from baseline to Weeks 24 and 48. The change in score at week X (where X=Week 24 or Week 48, as appropriate) calculated as: Change = week X score minus screening score.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145770|NCT00422942|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Weeks 24 and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145771|NCT00422942|Secondary|Change From Baseline in ACR Core Set|The changes from baseline in the ACR core set parameters at Week 48. Change from baseline to Week 48 over time in ACR core set: SJC, TJC, physician's global assessment of disease activity, patient's global assessment of disease activity, patient's assessment of pain, HAQ, ESR, and CRP. ACR20/50/70 response: ≥20%/50%/70% improvement in SJC; ≥20%/50%/70% improvement in TJC; and ≥20%/50%/70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; physician's global assessment of disease activity, participant's assessment of disease activity, participant assessment of functional disability via a HAQ, and CRP at each visit.|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145781|NCT00422903|Secondary|Time to Treatment Failure From the Start of the Primary Therapy|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death for any cause.|From Baseline (Day 1) up to study withdrawal (approx. 66 months)|ITT Population. Only those participants contributing data were analyzed.||Months||95% Confidence Interval|Median
149297|NCT00394654|Secondary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 126|All subjects who received at least one dose of investigational product (MEDI-528 or placebo)||Participants|||Number
145772|NCT00422942|Secondary|Percentage of Participants Achieving Response by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤ 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤ 1.2 with DAS28 ≤ 5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤ 1.2 with DAS28 >5.1.|Weeks 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145773|NCT00422942|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) Score|The change in DAS28-ESR at Weeks 12, 24, 36, and 48, relative to baseline. DAS28-ESR was calculated from SJC and TJC using 28-joint count, ESR (millimeters per hour [mm/hour]) and patient global assessment of disease activity (participant-rated arthritis activity assessment). Total score range: 0-9.4, higher score equals (=) more disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR <2.6 = remission.|Weeks 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145774|NCT00422942|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (20%) 50%, and 70% (ACR20/50/70) Response|ACR20/50/70 response is greater than or equal to (≥) 20%, 50%, or 70% improvement, respectively, in tender joint count (TJC) and swollen joint count (SJC); and improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145775|NCT00422942|Secondary|Change From Baseline in Myelocytomatosis Oncogene (C-myc) and BCL2-associated X Protein (BAX) in Peripheral Blood|The change in ribonucleic acid (RNA) expression of markers of apoptosis (C-myc and BAX) in peripheral blood at Days 15 and 183, relative to baseline.|Days 15 and 183|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145776|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in Synovial Tissues|The change in levels of key cytokines in (IL-1β, TNF-α, IL-6, and IL-10) in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145777|NCT00422942|Secondary|Change From Baseline in Levels of Key Cytokines (Interleukin [IL]-1beta [β], Tumor Necrosis Factor [TNF]-Alpha [α], IL-4, IL-6, IL-10, and IL-13) in Blood (Serum)|The change in levels of key cytokines (IL-1β, TNF-α, IL-4, IL-6, IL-10, and IL-13) in blood (serum) on Days 15 and 183 and at Weeks 4, 12, 24, 36, and 48, relative to baseline.|Days 15 and 183 and Weeks 4, 12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145778|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Peripheral Blood|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in peripheral blood at Weeks 4,12, 24, 36, and 48, relative to baseline.|Weeks 4,12, 24, 36, and 48|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145779|NCT00422942|Secondary|Change From Baseline in Absolute Counts of Cells Expressing CD20+ and CD22+ in Absolute B Cell (CD19+) Counts in Synovial Tissues|The change in absolute counts of cells expressing the key B cell markers (CD20+ and CD22+) in absolute B cell (CD19+) counts in synovial tissues at Weeks 12, 24, and 36, relative to baseline.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145780|NCT00422942|Primary|Change From Baseline in Absolute B Cell Cluster Differential 19 Positive (CD19+) Counts in Synovial Tissues|The change from baseline in absolute B cell (CD19+) counts at each visit calculated as (B cell count at visit minus B cell count at baseline) for synovial tissues.|Weeks 12, 24, and 36|No participant data were analyzed. Study was terminated after enrollment of 3 participants as it was decided that it would not be appropriate to expose further participants to study drug since the objectives and data sought from this study had been published from other, independent sources and given the recruitment difficulties encountered.|||||
145782|NCT00422903|Secondary|Mean Left Ventricular Ejection Fraction (LVEF)|Cardiac safety was evaluated as any signs or symptoms of deterioration in LVEF. LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. LVEF was evaluated using NCI CTCAE.|Baseline (Day 1), after 12 weeks, and after 24 weeks|ITT Population. Only those participants contributing data were analyzed.||Percent volume||Full Range|Mean
145783|NCT00422903|Secondary|Number of Participants With the Indicated Adverse Events With a Classification of >=Grade 2|Toxicity was measured in grades (severity of the AE) as per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening/disabling; Grade 5, death related to the AE. Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, and hypertension is high blood pressure.|From Baseline (Day 1) up to 6 months (until definitive surgery)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
145784|NCT00422903|Secondary|Percentage of Participants With Conversion From Planned Mastectomy at Baseline to BCS at Surgery|The percentage of participants who were planned to undergo a mastectomy at baseline but later underwent BCS was measured.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.||percentage of participants|||Number
145785|NCT00422903|Secondary|Number of Participants With the Indicated Type of Surgery|Mastectomy is the medical term for the surgical removal of one or both breasts. Breast-conserving surgery (BCS) involves removing only the affected part of the breast tissue during surgery, as opposed to removal of the entire breast.|At the point of definitive surgery (up to 6 months after Baseline 1)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
145786|NCT00422903|Secondary|Number of Participants With the Indicated Nodal Status at Surgery|The nodal status of cancer indicates the involvement of lymph nodes in the participant with cancer. N0 indicates no involvement of lymph nodes, and N+ indicates involvement of lymph nodes.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
145787|NCT00422903|Secondary|Number of Participants With Breast Tumors Per Pathological Stage at Surgery|Tumors were categorized as follows: T0, no evidence of primary tumor, but carcinoma of the milk ducts, accumulation of abnormal cells in the breast lobules, or Paget disease (cancer condition that appears like a skin disease involving the breast nipple) with no associated tumor mass; T1, tumor was <=2 centimeters (cm) across; T2, tumor was >2 cm but <5 cm across; T3, tumor was >5 cm across; T4, tumor of any size growing into the chest wall or skin, including inflammatory breast cancer.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population. Only those participants contributing data were analyzed.||participants|||Number
145788|NCT00422903|Secondary|Percentage of Participants With Pathological Complete Response (pCR) in the Breast and Axillary Nodes, Evaluated Using Miller and Payne Criteria|pCR is defined as the complete absence of infiltrating tumor cells (TCs) in the breast and lymph nodes. Miller and Payne criteria: Grade 1, no change/some alteration to individual malignant cells, but no reduction in overall cellularity; Grade 2, up to a 30% loss in TCs; Grade 3, between an estimated 30% and 90% reduction in TCs; Grade 4, more than a 90% reduction in TCs, only small cluster/dispersed cells remaining; Grade 5, no malignant identifiable cells; carcinoma in the milk ducts may be present. Grades 1 and 2 = No response; Grades 3 and 4= PR; Grade 5 = CR.|At the point of definitive surgery (up to 6 months after Baseline)|ITT Population||Percentage of participants||95% Confidence Interval|Number
145789|NCT00422903|Primary|Percentage of Participants With Various Responses in the Breast, Evaluated Using Per Protocol Criteria|Complete clinical response=nodule not detectable; all ultrasound abnormalities detected at diagnosis have disappeared. Partial clinical response=the tumor's longest diameter (LD) is reduced by 50% or more; ultrasound characteristics of the tumor persist. Minimal response=the tumor's LD is reduced by 25%-49%. Stable disease=the tumor's LD is decreased by less than 25% and is increased by no more than 25% from the starting value. Progressive disease=the tumor's LD is increased by more than 25% from the starting value. Participants who were not evaluable did not have data available.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|ITT Population. Three participants withdrew consent and were not included in the efficacy analysis.||percentage of participants|||Number
145790|NCT00422903|Primary|Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee|cOR is defined as the documented evidence of complete response (CR) and partial response (PR) as assessed by ultrasound examination using Response Evaluation Criteria In Solid Tumors (RECIST). CR is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). PR for TLs is defined as a >=30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs, it is defined as the persistence of >=1 non-TL and no new TLs or non-TLs.|From Baseline (Day 1) up to 6 months, evaluated every 12 weeks|Intent-to-Treat (ITT) Population: all participants who entered the study and received at least one dose of letrozole. Three participants withdrew consent and were not included in the efficacy analysis.||percentage of participants|||Number
145791|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales|Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9–12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
145792|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
145793|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response"|The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
145796|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response|The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
145797|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response"|The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of “yes” responses to the question during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
145798|NCT00422734|Secondary|"Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response"|The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
145799|NCT00422734|Primary|"Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3)."|The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.|Baseline and 12 weeks|all randomized participants having both baseline and at least one post-baseline data measurement||percent||Standard Error|Least Squares Mean
145800|NCT00422734|Secondary|Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain|The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).|12 weeks|all randomized participants having post-baseline data measurement on this variable||units on a scale||Standard Error|Least Squares Mean
145801|NCT00422734|Secondary|Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
145802|NCT00422734|Secondary|Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
145803|NCT00422734|Primary|Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)|The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
145804|NCT00422734|Primary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|Baseline and 12 weeks|last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement||units on a scale||Standard Error|Least Squares Mean
145805|NCT00422669|Secondary|Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up|Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
145806|NCT00422669|Secondary|Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up|Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
145807|NCT00422669|Secondary|The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up|LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
145808|NCT00422669|Secondary|The Change in Six-minute Hall Walk Distance|The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
145809|NCT00422669|Secondary|The Change in LVEF From Two Week Visit to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
145810|NCT00422669|Primary|The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up|Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.|Baseline and 24 months|Data required for the analysis were not collected due to early study termination. Analysis will not be done.|||||
145811|NCT00422656|Secondary|to Assess PFS and Duration of Response.||5 years||||||
145812|NCT00422656|Secondary|to Obtain Correlative Data in Patients With WM Treated With Perifosine||5 years||||||
145813|NCT00422656|Secondary|to Evaluate the Time to Progression in Patients With WM||5 years||||||
145814|NCT00422656|Secondary|To Evaluate the Toxicity of Perifosine in Patients With WM||1 year||||||
145815|NCT00422656|Primary|Response Rate Defined as Minimal, Partial or Complete Response in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Receiving Daily Perifosine at 150mg Orally.|Participants will be formally evaluated for response after the second cycle and at each subsequent cycle using the criteria from the Second International Workshop on Waldenstrom's Macroglobulinemia. Response was determined through review of routine blood tests, serum protein electrophoresis with quantitative M-spike, quantitative IgM level, and serum free light chain as well as tumor measurements by CT scan and bone marrow aspirate/biopsy.|participants were followed for response for the duration of the study, approximately 2 years|Included all patients who received any treatment.||participants|||Number
145816|NCT00422513|Secondary|The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants|A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.|Baseline, Month 1 to Month 7|Safety Population||number of participants|||Number
145817|NCT00422513|Secondary|Number of Participants Assessed for AEs|The adverse events are captured in the adverse event and serious adverse event section of this database.|Month 1 to 15 day follow up post month 7|Safety Population||number of participants|||Number
145818|NCT00422513|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Baseline, Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.||g/dL|||Number
145819|NCT00422513|Primary|Time Spent on Anemia Treatment Over Evaluation Period|Efficacy and pharmacoeconomics analyses were not performed.|Months 5-7|The safety population was the anticipated population analyzed. Efficacy and pharmacoeconomics analyses were not performed.||months|||Number
145820|NCT00422448|Secondary|Frequency of NRAS Mutations Among Nevi|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.|30 months|All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.||NRAS mutations|Participants||Number
145821|NCT00422448|Primary|Frequency of BRAF Mutations Among Nevi|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.|up to 30 months|All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.||BRAF mutations|Participants||Number
145822|NCT00422422|Secondary|Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period||Baseline to the end of the 3-week evaluation period|Although 99 subjects were in the Safety Set and confirmed to have taken at least one dose of BRV, details on study drug intake were not able to be collected for 2 subjects. Therefore compliance could only be calculated for 97 subjects.||participants|||Number
145823|NCT00422422|Secondary|Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period|||participants|||Number
145824|NCT00422422|Secondary|Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period||Baseline to end of the 3-week evaluation period|||participants|||Number
145825|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥12 to <16 Years||Day 21|||ug/mL||Full Range|Mean
145826|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥2 to <12 Years||Day 21|||ug/mL||Full Range|Mean
145827|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years||Day 21|||ug/mL||Full Range|Mean
145828|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years||Day 21|||ug/mL||Standard Deviation|Mean
145829|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years||Day 21|||ug/mL||Standard Deviation|Mean
145830|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years||Day 21|||ug/mL||Standard Deviation|Mean
145832|NCT00422383|Secondary|Percentage of Participants With a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers|ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive ≥ 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
145833|NCT00422383|Secondary|Percentage of Participants With Positive Human Anti-Chimeric Antibody (HACA) Titers|A participant was defined as being HACA positive if the HACA serum level was ≥ 5 relative units (RU) per mL and the physician comment read that participant was “immunodepletable with rituximab”.|BL, Weeks 24 and 48|SAP, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
145834|NCT00422383|Secondary|Change From BL in Activated Complement Component 4a (C4a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
145835|NCT00422383|Secondary|Change From BL in Complement C4 Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
145836|NCT00422383|Secondary|Percentage of Participants With Complement Component 4 (C4) Protein Level ≤ LLN|The LLN of C4 protein was defined as < 0.1 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||percentage of participants|||Number
145837|NCT00422383|Secondary|Change From BL in Activated Complement Component 3a (C3a) Protein Level in g/L||BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
145838|NCT00422383|Secondary|Change From BL in Complement C3 Protein Level in g/L|The LLN of C3 protein was defined as <0.9 g/L.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||g/L||Standard Deviation|Mean
145839|NCT00422383|Secondary|Percentage of Participants With Complement Component 3 (C3) Protein Level ≤ LLN|The LLN for C3 protein was defined as <0.9 grams per liter (g/L).|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint||percentage of participants|||Number
145840|NCT00422383|Secondary|Change From BL in Anti-CCP Antibody Titers in U/mL||Weeks 8, 24, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||U/mL||Standard Deviation|Mean
145841|NCT00422383|Secondary|Anti-Cyclic Citrullinated Peptide (CCP) Antibody Titers at BL in Units Per mL (U/mL)||BL|SAP. 3, 3, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, and High Dose, groups, respectively.||U/mL||Standard Deviation|Mean
145842|NCT00422383|Secondary|Percentage of Participants Who Were Rheumatoid Factor (RF) - Seronegative|Percentage of participants who were RF seropositive at BL who became RF seronegative over the course of the study. RF seropositive status was defined as RF ≥ 20 international units (IU) per mL. RF seronegative status was defined as RF < 20 IU/mL.|BL, Weeks 8, 24, and 48|RF seropositive participants from the ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
145843|NCT00422383|Secondary|Percentage of Participants With Total Immunoglobin (Ig), IgA, IgG, and IgM Results Below the LLN|The LLNs for total Ig, IgA, IgG, and IgM were defined as 6.75 grams per liter (g/L), 0.70 g/L, 65 g/L, and 0.40 g/L, respectively.|BL, Weeks 24 and 48|ITT-M2 population, n=number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
145844|NCT00422383|Secondary|Change From BL in Peripheral CD16+56+ Cell Count|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145845|NCT00422383|Secondary|Peripheral CD16+56+ Natural Killer (NK) Cell Count in Cells/µL|Simultaneous surface expression of CD16 and CD56 was assessed by FACS analysis as a marker of NK cell count.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145846|NCT00422383|Secondary|Change From BL in Peripheral CD8+ Cell Count|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145847|NCT00422383|Secondary|Peripheral CD8+ T Cell Count in Cells/µL|Surface expression of CD8 was assessed by FACS analysis as a marker of cytotoxic T lymphocyte count. The normal range of CD8+ T cells was defined as 220-1129 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145848|NCT00422383|Secondary|Change From BL in Peripheral CD4+ T Cell Count|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145849|NCT00422383|Secondary|Peripheral CD4+ T Cell Count in Cells/µL|Surface expression of CD4 was assessed by FACS analysis as a marker of T helper cell count. The normal range of CD4+ T cells was defined as 404-1612 cells/µL.|BL, Day 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|SAP, n = number of participants assessed for the given parameter at the specified timepoint.||cells/µL||Standard Deviation|Mean
145856|NCT00422383|Secondary|Percentage of Participants With Peripheral CD19+ B Cell Counts Above BL or the Lower Limit of Normal (LLN)|Surface expression of CD19 was assessed by FACS analysis as a marker of absolute B lymphocyte count. The LLN was defined as < 80 cells/µL.|BL, Days 1 and 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||percentage of participants|||Number
145857|NCT00422383|Secondary|Peripheral Cluster of Differentiation (CD) 19 Positive (+) B Cell Count at BL in Cells Per Microliter (Cells/µL)|Surface expression of CD19 was assessed by fluorescence-activated cell sorting (FACS) analysis as a marker of absolute B lymphocyte count.|BL|ITT-M2 population. 7, 8, 3, 1, and 2 participants were not analyzed for this outcome measure from the Low Dose, Escalated Dose, High Dose, Placebo, and Decreased Dose groups, respectively.||cells/µL||Standard Deviation|Mean
145858|NCT00422383|Secondary|Terminal Elimination Half-Life (t1/2) in the 1st and 2nd Courses of Treatment in Days|t1/2 values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||days||Standard Deviation|Mean
145859|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 2nd Infusion of Rituximab (Csecond) in the 1st and 2nd Courses of Treatment in µg/mL|Csecond values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.||µg/mL||Standard Deviation|Mean
145860|NCT00422383|Secondary|Maximum Observed Serum Concentrations Following the 1st Infusion of Rituximab (Cfirst) in the 1st and 2nd Courses of Treatment in Micrograms Per mL (µg/mL)|Cfirst values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.|Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.||µg/mL||Standard Deviation|Mean
145861|NCT00422383|Secondary|Change in SF-36 Score From BL|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Weeks 24 and 48|ITT-M2 population, n = number of participants analyzed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
145862|NCT00422383|Secondary|Short-Form 36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36 item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores.|BL, Week (Wk) 24 and 48|ITT-M2 population, n (number) = number of participants analyzed for the given parameter at the specified timepoint.||score on a scale||Standard Deviation|Mean
145863|NCT00422383|Secondary|Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score From BL at Week 48|"FACIT-F scores were obtained from a 13 question self-administered participant questionnaire designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants responded to the questions using a value between 0 and 4, where 0 indicated not at all and 4 indicated very much. 11 of the 13 questions were negatively stated; indicating the higher the score of the participant's response, the greater their fatigue. These questions were calculated as 4 minus the participants' response, so that a higher score indicated an improvement in health. The scores for the 2 positively stated questions were not changed. The participants' responses were summed to result in an overall score, which are scored 0 to 52 (52 = highest level of functioning). A positive change from BL indicated improvement."|BL, Week 48|ITT-M2 population. 9, 4, 2, and 1 participants were not evaluated for this outcome measure from the Low Dose, Escalated Dose, High Dose, and Decreased Dose groups, respectively.||score on a scale||Standard Deviation|Mean
145864|NCT00422383|Secondary|Percentage of Participants With a Response at Week 48 by European League Against Rheumatism (EULAR) Category|EULAR responses were categorized according to DAS28-ESR score. DAS28-ESR ≤ 3.2 at Week 48 and a change from BL to Week 48 < -1.2 = good response, DAS28-ESR ≤ 3.2 or greater than (>) 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 = moderate response, DAS28-ESR > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -1.2 = moderate response, DAS28-ESR ≤ 3.2 or > 3.2 and ≤ 5.1 at Week 48 and a change from BL to Week 48 ≥ -0.6 = no response, DAS28-ESR > 5.1 at Week 48 and a change from BL to Week 48 < -0.6 and ≥ -1.2 or ≥ -0.6 = no response.|Week 48|ITT-M2 population||percentage of participants|||Number
145865|NCT00422383|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR): Adjusted Mean Change From BL at Week 48|DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * participant's global assessment of disease activity (GH)]. DAS28-ESR ≥ 5.1 = high disease activity, DAS28-ESR less than or equal to (≤) 3.2 = low disease activity, DAS28-ESR less than (<) 2.6 = remission.|BL, Week 48|ITT-M2 population. Two participants from the Low Dose group and 1 participant from the Escalated Dose group were not evaluated for this outcome measure.||score on a scale||95% Confidence Interval|Mean
149349|NCT00394095|Secondary|Tolerability of Topiramate|To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.|12 weeks||||||
145866|NCT00422383|Secondary|Percentage of Participants With a ACR 70% Improvement Criteria (ACR70) Response at Week 48|ACR70 was defined as an overall score of 70 in the ACRn calculation. The Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR70 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population||percentage of participants|||Number
145867|NCT00422383|Secondary|Percentage of Participants With ACR 50% Improvement Criteria (ACR50) Response at Week 48|ACR50 was defined as an overall score of 50 in the ACRn calculation. Overall score defined as lowest percent improvement from BL of following 3 measures: TJC (68 joints), SJC (66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (VAS), HAQ, and CRP. If CRP missing, ESR was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. LOCF for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR50 set to Non-Responder if ACRn missing.|Week 48|ITT-M2 population||percentage of participants|||Number
145868|NCT00422383|Primary|Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20)|ACR20 defined as overall score of ≥20 in ACR number (ACRn) calculation. Overall score defined as lowest percent improvement from baseline (BL) of following 3 measures: tender joint count (TJC; 68 joints), swollen joint count (SJC: 66 joints), and the 3rd lowest improvement achieved by at least 3 of 5 remaining ACR core parameters: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant's assessment of pain (visual analog assessment [VAS]), Health Assessment Questionnaire (HAQ), and C-Reactive Protein (CRP). If CRP missing, erythrocyte sedimentation rate (ESR) was used. In order for improvements in the ACRn score to be expressed as a positive result, rather than the negative changes that improvements represent, the final ACRn results were multiplied by negative 1. Last observation carried forward (LOCF) for TJC/SJC, HAQ, CRP/ESR, VAS. If change in CRP incalculable, change in ESR used. ACR20 set to Non-Responder if ACRn missing|Week 48|ITT-M2 population||percentage of participants||95% Confidence Interval|Number
145869|NCT00422292|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age||Days 0 to 7 after vaccination|Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.||Percentage of Participants|||Number
145870|NCT00422292|Other Pre-specified|Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age|"Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.~Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability."|Days 0 to 7 after vaccination|||Percentage of Participants|||Number
145871|NCT00422292|Other Pre-specified|Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4||Day 30 after 12-month vaccination|||Percentage of Participants|||Number
145872|NCT00422292|Primary|Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4||Day 30 after the 12-month vaccination|Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.||Titers||95% Confidence Interval|Geometric Mean
145873|NCT00422292|Primary|Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)|Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.|Day 30 after the 12-month vaccination|Antibody responses were evaluated in the per-protocol population.||Percentage of Participants|||Number
145874|NCT00422279|Primary|Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading|The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench|Implant insertion, 3 months, 6 months|Implant stability was measured using a torque wrench, Resonance frequency analysis was conducted, radiographs were analyzed and computed tomography was performed||implants|Participants||Number
145875|NCT00422279|Secondary|Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)|"The secondary endpoint of the study was to assess the minimum dose of rhBMP2 eliciting bone growth.The secondary endpoint was assessed by measuring using a probe the quantity of any newly formed bone 1.in the group where implants were placed in the supra alveolar position the treatment is successful if the bone exceeds 1.5 mm above the initial alveolar bone level in all measured points 1. in the group where implants were placed in extraction sockets the treatment is successful if the gap between the implant body and the extraction socket is filled with Bone.~Safety dose used:- In the dog model; seroma formation was extensive with higher rhBMP-2 concentrations (3.0 and 4.0 mg/mL.Seromas was also significant in the dog model for the 0.75 and 1.5 mg/mL rhBMP-2 concentrations, hence a minimum dose of 15 and 30 µg per implants was chosen)"|3 months|1.When implants were placed in the supraalveolar position the treatment was not successful 2. in the group where implants were placed in extraction sockets the treatment was not successful||Number of participants with bone grow|||Number
145876|NCT00422227|Secondary|Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales|VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, “in general how would you rate your heath over the last 2-3 weeks”, 0mm equals very well and 100mm equals extremely bad. Pain VAS: “indicate the amount of pain experienced during the last 2-3 days”, 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: “how fatigued or tired have you been over the last week”, range =No Fatigue - Extremely Fatigued.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
145877|NCT00422227|Secondary|Percent Change From Baseline in Duration (Minutes) of Morning Stiffness|The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
145878|NCT00422227|Secondary|Percent Change From Baseline in Physician And Subject Global Assessments|The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
145879|NCT00422227|Secondary|Percent Change From Baseline in Painful and Swollen Joint Counts|Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen.|Week 2, 4, 8, 12, 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
145880|NCT00422227|Secondary|Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
145881|NCT00422227|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response|EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
145882|NCT00422227|Secondary|Percent Change From Baseline in DAS28 at Week 16|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percent change|||Number
145883|NCT00422227|Secondary|Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)|Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0–10 mm).|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
145884|NCT00422227|Secondary|Percentage of Participants Achieving ACR 20, 50, and 70 Responses|Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.|Week 16|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Percentage of Participants|||Number
145898|NCT00422162|Secondary|Clinical Global Impression of Improvement (CGI-I) at Each Visit|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145885|NCT00422227|Primary|Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks|"ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening.~The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks."|16 weeks|The mITT population, defined as all randomly assigned subjects who received at least 1 dose of ETN or MTX in the ETN group or 1 dose of usual DMARD therapy medication or MTX in the usual DMARD therapy group and had at least 1 postbaseline assessment.||Units on a scale||Standard Error|Mean
145886|NCT00422201|Secondary|Features of Cushing's Syndrome||8 weeks at steady dose||||||
145887|NCT00422201|Primary|Glycemic Disorders Improved or Normalized|"Criteria for improvement or normalization of glycemic disorders:~A. For diabetic patients (known or diagnosed at pre-inclusion visit)~Decrease in HbA1c > 0.3% B. For patients with IGT~Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL) D. For patients with IFG~If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion:~- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT < 7.8 mmol/L (140 mg/dL)~If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0):~- Normalization of fasting plasma glucose (fasting plasma glucose < 5.5 mmol/L (100 mg/dL)"|8 weeks at steady dose|18 patients were recruited. 7 completed the study but only 3 according to the last protocol version (in which primary efficacy criteria were changed), so only these 3 patients were to be analysed||participants|||Number
145888|NCT00422162|Secondary|Change From Baseline to Week 4 and Week 8 in Weight|Change in weight = Post-baseline visit minus baseline.|Baseline to Weeks 4 and 8|All randomized participants with at least one dose of study drug and a baseline and at least one post-baseline value. Last observation carried forward.||kilograms||Standard Deviation|Mean
145889|NCT00422162|Secondary|Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study|Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline.|over 8 weeks|All randomized participants with at least one dose of study drug.||participants|||Number
145890|NCT00422162|Secondary|Discontinuations Due to Adverse Events (AE)|Listing of adverse events (AE) that led to treatment discontinuation (DC).|over 8 weeks|All randomized participants with at least one dose of study drug.||participants|||Number
145891|NCT00422162|Secondary|Number of Patients With Potentially Clinically Significant Laboratory Findings|Laboratory results that were potentially clinically significant.|over 8 weeks|All randomized participants with at least one dose of study drug.||participants|||Number
145892|NCT00422162|Secondary|Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication|Number of participants using medication for anxiety and sleep disturbances.|over 8 weeks|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward. The total number of patients with hypnotics and anxiolytics concomitant therapies was 125 (Duloxetine 60mg) and 123 (Duloxetine 120mg).||participants|||Number
145893|NCT00422162|Secondary|Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8|"The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is not at all important and 6 is extremely important. The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6."|Baseline and Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
145894|NCT00422162|Secondary|Patients Reaching Remission|Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.|Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||participants|||Number
145895|NCT00422162|Secondary|Percentage of Responders|Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks.|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||percentage of participants|||Number
145896|NCT00422162|Secondary|Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline and Weeks 4 and 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145897|NCT00422162|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Each Visit|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145920|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 104|Calculated as mean blood pressure at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmHg||Standard Deviation|Mean
145899|NCT00422162|Secondary|Clinical Global Impression of Severity (CGI-S) Scores at Each Visit|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145900|NCT00422162|Secondary|Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)|"Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe)."|4 to 8 weeks|All randomized participants who received at least one dose of study drug and had a Week 4 and at least one following value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
145901|NCT00422162|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
145902|NCT00422162|Secondary|Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline|"The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe)."|Baseline to Weeks 1, 2, 3, 4, 6, 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value. Last observation carried forward. Participants were assigned their responder status at Week 4 and the data were retrospectively divided into these groups.||units on a scale||Standard Deviation|Mean
145903|NCT00422162|Primary|Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 4|All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.||units on a scale||Standard Deviation|Mean
145904|NCT00422097|Secondary|Number of Participants With Abnormal (CTC Grade 3 or Greater) Serum Chemistry Levels|Upper limit of normal (ULN)=upper level of normal among all laboratory ranges. Alkaline phosphatase(U/L): Gr 3: >5.0-20.0*ULN; Gr 4: >20.0*ULN. Sodium (mEq/L): Gr 3: 120-<130 or >155-160; Gr 4 <120. Potassium (mEq/L): Gr 3: 2.5-<3.0 or >6.0-7.0; Gr 4: <2.5 or >7.0. Calcium (mg/dL): Gr 3: 6.0-<7.0 or >12.5-13.5; Gr 4: <6.0 or >13.5. Inorganic phosphorus (mg/dL): Gr 3: 1.0-<2.0; Gr 4: <1.0. Albumin (g/dL): Gr 3: <2.0.|At screening and predose Day 1, Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.||Participants|||Number
145905|NCT00422097|Secondary|Number of Participants With Significant Findings on Physical Examination or Electrocardiogram (ECG)|Physical examination evaluated height, weight, Eastern Cooperative Oncology Group performance status, adverse events, and abnormal laboratory findings and included a neurologic examination to evaluate deep tendon reflexes, sensory modalities, and motor strength. Participants also underwent a 12-lead ECG screening. Physical examination findings and ECG findings were considered clinically significant at the investigator's discretion.|At screening and predose Day 1, Cycle 1 (21 days)|Although physical examinations and ECGs were performed, the findings were not summarized.||Participants|||Number
145906|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given alone once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.||ng*h/mL||Standard Deviation|Mean
145907|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.||ng/mL||Full Range|Median
145919|NCT00422097|Secondary|Number of Participants With Death as Outcome, Treatment-related Adverse Events (AEs), and AEs Leading to Discontinuation|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21 (Cycle 1), continuously|All Treated Subjects: All subjects who received at least 1 dose of ixabepilone.||Participants|||Number
154690|NCT00343083|Secondary|Pathological Response to Cetuximab|Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing|2 years|||participants|||Number
145908|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone With and Without Famotidine in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they receive famotidine, 40 mg. Prior to dosing on Day 1 of Cycle 2, famotidine administered in an oral dose 2 hours before ixabepilone 25-mg dose.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|Participants who received ixabepilone, at the MTD of 25 mg, alone in Cycle 1 and had adequate concentration profiles. Participants then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine,40 mg, on Day 1 of Cycle 2.||ng/mL||Standard Deviation|Mean
145909|NCT00422097|Secondary|Area Under the Curve in 1 Dosing Interval (AUC[TAU]) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).||ng*h/mL||Standard Deviation|Mean
145910|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax)of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the ixabepilone MTD (25 mg) has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg).||ng/mL||Full Range|Median
145911|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Oral Ixabepilone at MTD in Fasted and Fed Participants in Crossover Cohorts|After the MTD has been defined, participants who completed Cycle 1 (ixabepilone, 25 mg, given once daily orally on Days 1 through 5 of 21-day cycle, with participants fasting at least 4 hours before and 4 hours after treatment on all dosing days) then cross over to Cycle 2, during which they consume a standard lowfat meal starting 30 minutes prior to ixabepilone, 25 mg, administration on Day 1 of Cycle 2 only. Meal is consumed within a 30-minute period. Administration of the total oral dose should not exceed more than 10 minutes from start to finish.|Up to 24 hours postdose Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (21 days)|All participants who received ixabepilone and who had adequate concentration profiles. Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine (Cycle 2).||ng/mL||Standard Deviation|Mean
145912|NCT00422097|Secondary|Plasma Half-life (T-Half) of Ixabepilone||Day 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles||Hours||Standard Deviation|Mean
145913|NCT00422097|Secondary|Area Under the Concentration-time Curve in 1 Dosing Interval (AUC[TAU])of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles.||ng*h/mL||Standard Deviation|Mean
145914|NCT00422097|Secondary|Time of Maximum Plasma Concentration (Tmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles||Hour||Full Range|Median
145915|NCT00422097|Secondary|Maximum Plasma Concentration (Cmax) of Ixabepilone||Days 1 and 5 of Cycle 1|All participants who received ixabepilone and who had adequate concentration profiles||ng/mL||Standard Deviation|Mean
145916|NCT00422097|Primary|Number of Participants With DLTs by Worst Common Terminology Criteria (CTC) Grade|Adverse events (AEs) graded by CTC version 3. Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=life threatening; Gr 5=Death related to AE. DLT is defined as an event related to ixabepilone that occurs during the first course of treatment. Includes neutropenia; thrombocytopenia; Gr 3 or 4 nausea, vomiting, or diarrhea despite adequate medical intervention and prophylaxis; Gr 3 fatigue or asthenia; transient arthralgia or myalgia unresponsive to medical intervention; any Gr 3 nonhematologic toxicity; and prolonged recovery from a toxicity.|Days 1 through 21 (Cycle 1), continuously|All Treated Participants: All participants who received at least one dose of ixabepilone were included.||Participants|||Number
145917|NCT00422097|Secondary|Number of Participants With Abnormal Laboratory Values by Worst CTC Grade|Lower limit of normal (LLN)=lowest level of normal among all laboratory ranges. Hemoglobin (g/dL): Gr 1: 10.0-<LLN; Gr 2: 8.0-<10.0; Gr 3:6.5-<8.0; Gr 4: 6.5. Leukocytes (c/uL): Gr 1: 3.0-<LLN; Gr 2: 2.0-<3.0; Gr 3: 1.0-<2.0; Gr 4: <1.0. Lymphocytes (c/uL): Gr 1: 0.8-<1.5; Gr 2: 0.5-<0.8; Gr 3: 0.2-<0.5; Gr 4: <0.2. Neutrophils (Absolute)(c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Neutrophils + Bands (c/uL): Gr 1: 1.5-<2.0; Gr 2: 1.0-<1.5; Gr 3: 0.5-<1.0; Gr 4: <0.5. Platelet Count (c/uL):Gr 1: 75.0-<LLN; Gr 2: 50.0-<75.0; Gr 3: 25.0-<50.0; Gr 4: <25.0.|Baseline and Days 1, 8, and 15 of Cycle 1 (21 days)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.||Participants|||Number
145918|NCT00422097|Primary|Maximum Tolerated Dose (MTD) of Ixabepilone|MTD is based on Cycle 1 data only and defined as the maximum dose that can be administered to 6 participants with no more than 1 experiencing a dose-limiting toxicity (DLT) (or fewer than one third of participants if more than 6 receive treatment) with at least 2 participants experiencing a DLT at the next higher dose level. DLT=an event, such as neutropenia; thrombocytopenia; Gr 3 or 4 nausea or diarrhea; Gr 3 fatigue or asthenia; transient arthralgia or recalcitrant myalgia; and prolonged recovery from a toxicity, that occurs during the first course of treatment.|Days 1 through 21 (Cycle 1)|All Treated Subjects: All subjects who received at least one dose of ixabepilone were included.||mg/d|||Number
145958|NCT00421889|Secondary|Belinostat Cmax||Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 41 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.||ng/mL||Standard Deviation|Mean
145921|NCT00422058|Secondary|Change From Baseline in Blood Pressure at Week 20|Calculated as mean blood pressure at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmHg||Standard Deviation|Mean
145922|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 104|Calculated as mean waist circumference at week 104-baseline.|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||cm||Standard Deviation|Mean
145923|NCT00422058|Secondary|Change From Baseline in Waist Circumference at Week 20|Calculated as mean waist circumference at week 20-baseline.|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||cm||Standard Deviation|Mean
145924|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 104|Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mcg/mL||Standard Deviation|Mean
145925|NCT00422058|Secondary|Change From Baseline in Adiponectin at Week 20|Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mcg/mL||Standard Deviation|Mean
145926|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 104|Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||g/L||Standard Deviation|Mean
145927|NCT00422058|Secondary|Change From Baseline in Fibrinogen at Week 20|Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||g/L||Standard Deviation|Mean
145928|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||U/mL||Standard Deviation|Mean
145929|NCT00422058|Secondary|Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20|Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||U/mL||Standard Deviation|Mean
145930|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mg/L||Standard Deviation|Mean
145931|NCT00422058|Secondary|Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20|Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||mg/L||Standard Deviation|Mean
145932|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||percentage (%) of total haemoglobin||Standard Deviation|Mean
145933|NCT00422058|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20|Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||percentage (%) of total haemoglobin||Standard Deviation|Mean
145934|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 104|Calculated as mean fasting insulin at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||pmol/L||Standard Deviation|Mean
145935|NCT00422058|Secondary|Change From Baseline in Fasting Insulin at Week 20|Calculated as mean fasting insulin at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).||pmol/L||Standard Deviation|Mean
145936|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 104|Calculated as mean fasting plasma glucose at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmol/L||Standard Deviation|Mean
145937|NCT00422058|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 20|Calculated as mean fasting plasma glucose at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product||mmol/L||Standard Deviation|Mean
145938|NCT00422058|Secondary|Mean Change From Baseline in Body Weight at Week 104|Calculated as mean body weight at week 104 - baseline|Week 0, week 104|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.||kg||Standard Deviation|Mean
145939|NCT00422058|Primary|Mean Change From Baseline in Body Weight at Week 20|Calculated as mean body weight at week 20 - baseline|Week 0, week 20|ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.||kg||Standard Deviation|Mean
154691|NCT00343083|Secondary|Overall Survival and Disease-free Survival||3 years (overall) 2 years disease-free|||percentage of participants|||Number
145940|NCT00422032|Primary|Number of Participants With Response for Two Dose Schedules of Clofarabine|Response defined as Complete Remission (CR): Normalization of blood counts with neutrophils >/= 1 * 10^9/L and platelet counts >/= 100 * 10^9/L, and marrow blasts </=5%; Partial Remission: as above except for presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment; or Hematologic Improvement (HI): Complete Response (CR) with the exception of a lack of platelet recovery to >/= 100 * 10^9/L. Repeat bone marrow samples collected every 1-3 cycles (4-8 week cycle).|4 weeks (minimum 1 cycle) up to 24 weeks (maximum 3 cycles of 8 weeks)|||Participants|||Number
145941|NCT00421993|Secondary|Percent Change in Total Lesion Counts|Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF||Percent change||Standard Deviation|Mean
145942|NCT00421993|Secondary|Percent Change in Noniflammatory Lesion Counts|Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF||Percent change||Standard Deviation|Mean
145943|NCT00421993|Secondary|Percent Change in Inflammatory Lesion Counts|Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100|at week 12|ITT, LOCF||Percent change||Standard Deviation|Mean
145944|NCT00421993|Primary|Changes in Noninflammatory Lesion Counts|Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count|from Baseline to week 12|ITT, LOCF||Lesion count||Full Range|Median
145945|NCT00421993|Primary|Changes in Inflammatory Lesion Counts|Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts|from Baseline to week 12|ITT, LOCF||Lesion count||Full Range|Median
145946|NCT00421993|Primary|Success Rate on the Investigator's Global Assessment|Percentage of subjects rated “Clear” and “Almost Clear” on 5-point scale (0=clear; 4=severe)|at week 12|Intention to treat (ITT), last observation carried forward (LOCF).||Percentage of participants|||Number
145947|NCT00421954|Primary|Weight Gain and Other Side Effects||couple of months|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.|||||
145948|NCT00421928|Secondary|Change From Baseline in Responder Analysis 50% Improvement to Week 12|"Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and Week 12|ITT. Subjects who discontinued from the study were considered non-responders.||Percentage of participants|||Number
145949|NCT00421928|Secondary|Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12|"Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead"|Baseline and 12 week endpoint|ITT||scores on a scale||Standard Deviation|Mean
145950|NCT00421928|Secondary|Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy|The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint|Baseline to 12 weeks|ITT: The results for median and interquartile ranges were not estimable because insufficient number of subjects discontinued due to lack of efficacy to estimate the values.||median time|||Number
145951|NCT00421928|Secondary|Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12|Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)|Baseline and 12 week endpoint|ITT||percentage of participants|||Number
145952|NCT00421928|Secondary|Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.|"A Sleep Questionniare addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement."|Baseline and 12 week endpoint|ITT||Hours||Standard Deviation|Mean
145953|NCT00421928|Secondary|Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12|Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability|Baseline and 12 week endpoint|Intent To Treat (ITT), observed cases analysis conducted, no imputation performed.||Scores on a scale||Standard Deviation|Mean
145954|NCT00421928|Primary|Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.|"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation||Scores on a scale||Standard Deviation|Mean
145955|NCT00421889|Primary|Dose Limiting Toxicities (DLT), Part A|To determine the number of participants experiencing dose limiting toxicities of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin and paclitaxel or both.|Cycle 1|||participants|||Number
145956|NCT00421889|Secondary|Belinostat AUC (0-infinity)||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters.||ng*h/mL||Standard Deviation|Mean
145957|NCT00421889|Secondary|Belinostat Mean t½||Cycle 1 Day 1: Cycle 1 day 1: Pre-Infusion, 0 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 3 h 15 min, 3 h 30 min, 4 h, 5 h, 6 h, 6 h 15 min, 6 h 30 min, 7h, 8h, 9h, 24h|The Pharmacokinetic Analysis Subset consisted of 39 patients who enrolled in the study and provided a complete or partial set of pharmacokinetic parameters||hours||Standard Deviation|Mean
145961|NCT00421889|Secondary|Time to Progression|Time to progression, defined as the interval between the first dates of treatment until the first notation of disease progression. RECIST criteria|Throughout study|Per protocol Population, includes all patients who have received at least two cycles (complete treatment days, dose reductions per protocol allowed) of study treatment and who have also had at least one post-baseline tumor assessment. Not done for Part A.||days||95% Confidence Interval|Median
145962|NCT00421889|Secondary|To Determine the Pharmacodynamic Effects of Belinostat (in the Combination) on Histone Acetylation in Peripheral Blood Mononuclear Cells (Selected Sites)||Throughout the study|Histone acetylase analysis was planned, but not successful due to technical issues with the method.|||||
145963|NCT00421889|Secondary|Best Overall Response (CR or PR)|Best overall responses were assessed by RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Clinical tumor evaluation will take place after each cycle. Formal radiological evaluation after every 2 cycles. If a response is noted, a follow-up radiographic assessment must be performed 4 weeks (+ 1 week) after the response is noted|Throughout study until PD (progressive disease) or lost to follow up|Primary efficacy analysis population, includes all patients who have been enrolled into the study and received at least one dose of study medication.||participants|||Number
145964|NCT00421889|Primary|Maximum Tolerable Dose (MTD) Belinostat, Part A,|To determine the maximum tolerated dose of belinostat (PXD101) in doses up to 1000 mg/m²/day administered in combination with standard doses of carboplatin (AUC of 5) and paclitaxel (175 mg/m2).|Cycle 1|||mg/m2|||Number
145965|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.|Change is mean change in picograms of iPTH per milliliter of serum.|Baseline (screening period) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline and a last on-treatment measurement were excluded from the analyses.||picogram/milliliter||Standard Deviation|Mean
145966|NCT00421733|Secondary|Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.|The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.||log milligrams of albumin per 24 hours||Standard Deviation|Mean
145967|NCT00421733|Secondary|Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.|Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.||Participants|||Number
145968|NCT00421733|Primary|Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).|UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.|Baseline (within 1 week prior to first treatment) through 24 weeks of treatment|Intent-to-treat population, which was all randomized participants who received at least 1 dose of study drug. Subjects without both a baseline and last on-treatment measurement were excluded from the primary efficacy analysis. As such, sample size was N=88 for placebo, N=92 for 1 mcg and for 2 mcg paricalcitol, and N=184 for combined paricalcitol.||log milligram/gram creatinine||Standard Deviation|Mean
145969|NCT00421603|Primary|Pattern of Cocaine Use as Measured by the TimeLine Followback||recorded daily for the 14 weeks of the trial or length of participation||||||
145970|NCT00421603|Primary|Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report|Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.|3 weeks of abstinence during 14 weeks of trial or for length of participation|||participants|||Number
145971|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at 18 Months|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 18 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.||mg/cm^3||Standard Error|Least Squares Mean
145972|NCT00421408|Primary|Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) at Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at 0 months|All participants were analyzed using the mixed models method. For the Quantitative Computed Tomography (QCT) test only half of the participants were randomized to receive it.||mg/cm^3||Standard Error|Least Squares Mean
145973|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 18 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 18 months|All participants were analyzed using the mixed models method.||g/cm^2||Standard Error|Least Squares Mean
145974|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at 9 Months|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 9 months|All participants were analyzed using the mixed models method.||g/cm^2||Standard Error|Least Squares Mean
145975|NCT00421408|Primary|Anterior-posterior Spine Bone Mineral Density Measured by Dual Energy X-ray Absorptiometry (DXA) at Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at 0 months|All participants were analyzed using the mixed models method.||g/cm^2||Standard Error|Least Squares Mean
145976|NCT00421408|Primary|Change in Spine Bone Mineral Density Measured by Quantitative Computed Tomography (QCT) Compared to Baseline|There is no normative data for quantitative computed tomography it is based on local experience.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis. Only half of the study partipants were randomized to receive Quantitative Computed Tomography testing.||percent change||Standard Error|Mean
145977|NCT00421408|Primary|Change in Anterior-posterior Spine Bone Mass Density Measured by Dual Energy X-ray Absorptiometry (DXA) Compared to Baseline|There is no absolute normative range for bone mineral density. Population norms have been established for specific races and men and women for the hip based on data collected by National Health Examination Nutrition Surveys (NHANES) and for the spine based largely on data collected by individual manufacturers. Values within 1 standard deviation of the population mean are generally considered normal. Values below 1 standard deviation from the population mean are generally considered to reflect reduced bone mass.|Measured at baseline and 18 months|Only participants with data at the baseline and 18 month timeframe were used in the analysis.||percentage change||Standard Error|Mean
145978|NCT00421343|Secondary|Reasons for Non-willingness to Particiapte and Non-adherence With Intervention|We asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.|6 months||||||
145979|NCT00421343|Primary|Number Adherent With the Intervention||6 months|||participants|||Number
145980|NCT00421174|Secondary|Pro-inflammatory Markers of Pulmonary Disease, in Both BAL Fluid and Plasma||Day 28|No data collected|||||
145981|NCT00421174|Secondary|Dermatologic Reaction||Day 28|No data collected|||||
145982|NCT00421174|Secondary|Overall Mortality||Year 2|||participants|||Number
145983|NCT00421174|Secondary|Incidence of Relapse|Percentage of patients who experience relapse. Deaths without relapse are considered as a competing risk.|Year 1|||percentage of participants|||Number
145984|NCT00421174|Secondary|Incidence of Graft-vs-Host-Disease (GVHD)||Year 1|||percentage of participants||95% Confidence Interval|Number
145985|NCT00421174|Secondary|Incidence of Toxicity||Day 56|||Toxcities|Total number of toxicities||Number
145986|NCT00421174|Secondary|Incidence of Infection||Day 56|||Infections|Total number of infections||Number
145987|NCT00421174|Secondary|Overall Survival|Percentage of patients that survived after one year|Year 1|||percentage of participants||95% Confidence Interval|Number
145988|NCT00421174|Secondary|Corticosteroid Dose|Patients were treated with systemic corticosteroids with methylprednisolone at 2 mg/kg/day on day 0, with taper allowed after day 7.|Day 14 and 28|||mg/kg/day||Full Range|Median
145989|NCT00421174|Secondary|Discontinuation of Supplemental Oxygen|The “time required to discontinue supplemental oxygen” will be measured in the number of days from study entry.|Day 56|||days||Full Range|Median
145990|NCT00421174|Secondary|Response to Therapy|Response will be defined as the ability to survive to Day 56 of study, plus the ability to completely discontinue all supplemental oxygen support for > 72 consecutive hours during this time period.|Day 56|||percentage of participants||95% Confidence Interval|Number
145991|NCT00421174|Primary|Response Rate|Response will be defined as survival to Day 28 of study, plus discontinuation of all supplemental oxygen support for more than 72 consecutive hours by Day 28.|Day 28|||percentage of participants||95% Confidence Interval|Number
145992|NCT00420992|Primary|Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)|Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.|randomization to 12 weeks following randomization|intent to treat (ITT)||units on scale||Standard Deviation|Mean
145993|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (severe joint damage). The Disease Activity Score (DAS28) ranges from 0.49 to 9.07, with scores less than 2.6 indicating clinical remission.|Week 78|||Participants|||Number
145994|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), a score of 0-1 represents mild to moderate, 1-2 moderate to severe, 2-3 severe to very severe disability. The modified Total Sharp score (mTSS) ranges from 0 (no joint damage) to 448 (worst joint damage). American College of Rheumatology 70% (ACR70) response indicates at least 70% improvement in tender and swollen joint counts and at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; HAQ-DI; and C-reactive protein.|Week 78|||Participants|||Number
154692|NCT00343083|Secondary|Local Regional Control at 2 Years||2 years|||percentage of participants|||Number
145995|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78|In the Health Assessment Questionnaire Disability Index (HAQ-DI), participants rated their ability to perform daily tasks on a scale of 0 (without any difficulty) to 3 (unable to do). A mean score of 0-1 represents mild to moderate functional disability, 1-2 represents moderate to severe, 2-3 severe to very severe disability. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|||Participants|||Number
145996|NCT00420927|Secondary|Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78|Synovitis was assessed using high-field magnetic resonance imaging (MRI) of the hand and wrist. Images were read and scored according to the Outcomes Measures in Rheumatology Clinical Trials' Rheumatoid Arthritis MRI Scoring System (OMERACT RAMRIS). Synovitis in the wrist and finger joints in the most affected hand was scored from 0 (normal) to 3 (severe), for a maximum total score of 21.|Baseline to Week 78|The analysis is based on the Primary Analysis Set, a subset of the ITT Analysis Set that includes subjects who participated in the 78-week HF MRI substudy and whose Baseline HF MRI data were collected on or before the first study drug dose. Observed scores are used in the analysis.||Scores on a scale||Standard Deviation|Mean
145997|NCT00420927|Secondary|Change From Baseline in SDAI Score at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Baseline to Week 78|||Scores on a scale||Standard Deviation|Mean
145998|NCT00420927|Secondary|Change From Baseline in CDAI Score at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Baseline to Week 78|||Scores on a scale||Standard Deviation|Mean
145999|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
146000|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
146001|NCT00420927|Secondary|Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78|The SDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, physician's global assessment of disease activity, and acute phase reactant (C-reactive protein). Scores range from 0.1 to 86.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
146002|NCT00420927|Secondary|Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78|The CDAI is calculated using number of swollen joints (28 joints assessed), number of tender joints (28 joints assessed), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76.0, with a higher score reflecting worsening disease.|Week 78|||Participants|||Number
146003|NCT00420927|Secondary|Change From Baseline in DAS28 Score at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Baseline to Week 78|||Scores on a scale||Standard Deviation|Mean
146004|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 70% improvement in tender joint count; greater than or equal to 70% improvement in swollen joint count; and greater than or equal to 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation||Participants|||Number
146005|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78|Subjects were responders if they had: greater than or equal to 50% improvement in tender joint count; greater than or equal to 50% improvement in swollen joint count; and greater than or equal to 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation||Participants|||Number
146006|NCT00420927|Secondary|Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78|Subjects were responders if they had greater than or equal to 20% improvement in tender joint count; greater than or equal to 20% improvement in swollen joint count; and greater than or equal to 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (C-reactive protein).|Week 78|ITT Population, nonresponder imputation||Participants|||Number
146007|NCT00420927|Secondary|Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78|For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Week 78|ITT Population, nonresponder imputation||Participants|||Number
146008|NCT00420927|Secondary|Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, nonresponder imputation||Participants|||Number
146009|NCT00420927|Secondary|Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07. A DAS28 less than 2.6 indicates clinical remission, DAS28 2.6 to 3.2 indicates low disease activity, DAS28 3.2 to less than 5.1 indicates moderate disease activity, and DAS28 of 5.1 or greater indicates high disease activity.|Week 78|ITT Population, Nonresponder imputation||Participants|||Number
146010|NCT00420927|Secondary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|||Participants|||Number
146011|NCT00420927|Primary|Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4|The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.|Week 78|The analysis was performed on the ITT Population comprised of all subjects who entered Period 2 and received at least 1 dose of study drug (blinded or open-label) during Period 2. Nonresponder imputation was used for missing data.||Participants|||Number
146012|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146013|NCT00418834|Other Pre-specified|Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146014|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146015|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146016|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146017|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146018|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146019|NCT00418834|Other Pre-specified|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146020|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146021|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC): High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146022|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146023|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146024|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146025|NCT00418834|Other Pre-specified|Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146026|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146027|NCT00418834|Other Pre-specified|Percent Change From Baseline in Triglycerides (TG) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146028|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146029|NCT00418834|Other Pre-specified|Percent Change From Baseline in Total Cholesterol (TC) at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis."||Percent Change||95% Confidence Interval|Least Squares Mean
146030|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseine and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146031|NCT00418834|Other Pre-specified|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146032|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146150|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 124 mmHg||mmHg||Standard Deviation|Mean
146033|NCT00418834|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
146034|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12||Week 12|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Participants|||Number
146035|NCT00418834|Secondary|Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6||Week 6|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Participants|||Number
146036|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12||Week 12|"Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis."||Participants|||Number
146037|NCT00418834|Secondary|Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||Week 6|"Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis."||Participants|||Number
146038|NCT00418834|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|"Full Analysis Set (FAS): The FAS~population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL)~value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind~study medication were included in the analysis."||Percent Change||95% Confidence Interval|Least Squares Mean
146039|NCT00418834|Primary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|"Full Analysis Set (FAS): The FAS population~includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at~least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication~were included in the analysis."||Percent Change||95% Confidence Interval|Least Squares Mean
146040|NCT00418717|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. In this analysis, the AUC is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12). Blood samples were taken on day 0 of PK analysis and collected every day after for 7 days for weeks 4 and 12.|7 days after week 4 and 7 days after week 12|The analysis population was the Pharmacokinetic (PK) subset, which included all patients who completed the 25 mg BW dose treatment period, received at least 1 dose of 50 mg QW and elected to participate in the PK assessment. Data on observed cases: 18 patients from ETN 25 mg BW (week 4) and 17 patients from ETN 50 mg QW (week 12).||ug*Day/mL||Standard Deviation|Mean
146041|NCT00418717|Primary|Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.|DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).|weeks 4 and 12|The analysis population was modified intent to treat (mITT), which included all patients who completed the 25 mg BW dose treatment period and received at least 1 dose of 50 mg OW. Data on observed cases: 41 patients from ENT 25 mg BW (week 4) and 39 patients from ETN 50 mg OW (week 12).||units on scale||Standard Deviation|Mean
146042|NCT00418691|Primary|Patient Cognitive Test Scores at End of Treatment Period|For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).|Baseline to end of Week 4 treatment period||||||
146043|NCT00418691|Primary|Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score|'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow “trail” made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).|Baseline to 4-5 weeks on study medication|Analysis were per protocol. The z-score reflects how many standard deviations above or below the population mean a raw score is for each participant.||z-scores||Standard Deviation|Mean
146044|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146045|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146046|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146047|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146048|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146049|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146050|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146051|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146052|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146053|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146054|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
156481|NCT00323479|Secondary|Percentage of Participant With Therapeutic Maintenance Under Anastrozole|Treatment compliance. results based on 109 patients due to missing values|12 months|||percentage of participants|||Number
146055|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146056|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146057|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146058|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146059|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146060|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146061|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146062|NCT00420849|Secondary|Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Week 24|Full analysis set of participants who completed the questionnaire at baseline and week 24.||units on a scale||Standard Deviation|Mean
146063|NCT00420849|Secondary|Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population||weeks||Standard Deviation|Mean
146064|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Venous Thromboembolic Events|Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population||participants|||Number
146065|NCT00420849|Secondary|Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)|Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.|up to 124 weeks|Safety population||weeks||Standard Deviation|Mean
149392|NCT00393705|Secondary|Total Daily Insulin Dose at 4 Weeks and 12 Weeks||4 weeks and 12 weeks|Number of patients who received at least one dose of study drug and had a post-baseline insulin measurement at week 4 and week 12.||International Units (IU)||Standard Deviation|Mean
146066|NCT00420849|Secondary|Participants With Adverse Events of Special Interest: Peripheral Neuropathy|Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.|up to 124 weeks|Safety population||participants|||Number
146067|NCT00420849|Primary|Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment|"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.~National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death."|up to 123 weeks|Safety population||participants|||Number
146068|NCT00420784|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Week 2, 4, 8, 12, 16, 24|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
146069|NCT00420784|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
146070|NCT00420784|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to 2 weeks after last dose of study drug (up to Week 50)|Full Analysis Set = subjects who received at least 1 dose of study drug.||participants|||Number
146071|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA|"Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week and at 48 weeks after last dose of study drug for treatment groups Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL)."|Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)|Full Analysis Set = subjects who received at least 1 dose of study drug.||percentage of participants|||Number
146072|NCT00420784|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|Full Analysis Set = subjects who received at least 1 dose of study drug.||percentage of participants|||Number
146073|NCT00420784|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|Full Analysis Set = subjects who received at least 1 dose of study drug||percentage of participants|||Number
146074|NCT00420745|Secondary|Serum Anti–Rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals, calculated on all subjects.|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort. The anti-rotavirus IgA antibody GMC for Placebo Group was below the assay cut-off (<20 U/mL), so could not be computed.||U/mL||95% Confidence Interval|Geometric Mean
146075|NCT00420745|Secondary|Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Number of subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL).|At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the According-to-Protocol immunogenicity cohort that included all subjects with at least one study vaccine or placebo administered, for whom immunogenicity data were collected and available and who complied with the inclusion criteria defined in the protocol.||subjects|||Number
146076|NCT00420745|Secondary|Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.|Gastroenteritis (GE): diarrhoea with or without vomiting. Rotavirus (RV) GE: A GE episode was a RV GE if a stool sample taken during or not later than 7 days after the episode was RV positive by Enzyme Linked Immunosorbent Assay.|From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.||subjects|||Number
146077|NCT00420745|Secondary|Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.|Solicited symptoms included Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5 degrees Celsius (°C)), Irritability, Loss of appetite, and Vomiting|Within 15 days after each Rotarix vaccine/Placebo dose.|The analyses were performed on the Total vaccinated cohort for the safety and the immunogenicity subset that included all subjects with at least one study vaccine or placebo administered and for whom solicited symptoms were collected.||subjects|||Number
146078|NCT00420745|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any Rotarix vaccine/Placebo dose.|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.||subjects|||Number
146079|NCT00420745|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo|The analyses were performed on the Total Vaccinated Cohort that included all the subjects with at least one study vaccine or placebo administration documented.||subjects|||Number
146080|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 3|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 3 (day 15)|Efficacy sample - Study eye||Units on a scale 0-4||Standard Deviation|Mean
146081|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 2|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 2 (day 8)|Efficacy population - Study eye||Units on a scale 0-4||Standard Deviation|Mean
146082|NCT00420628|Secondary|Assessment of Ocular Signs in the Study Eye - Visit 1|Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.|Visit 1 (day 1)|Efficacy sample, non-missing data||Units on a scale 0-4||Standard Deviation|Mean
146083|NCT00420628|Primary|Treatment Emergent Adverse Events|Study eye - Safety Population, At all visits 1,2,3|day 1, day 8, day 15|Safety population, Study eye||participants|||Number
146084|NCT00420628|Secondary|Investigators Global Assessment of the Clinical Condition|The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.|Visit 3, day 8|Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)||Participants|||Number
146085|NCT00420511|Secondary|Proportion of Patients Achieving Sustained Normoglycemia Off Medication at 1-week Post-insulin Therapy||1 year||||||
146086|NCT00420511|Secondary|Time to Loss of Glycemic Control||1 year||||||
146087|NCT00420511|Secondary|Area-under-the-glucose-curve (AUCglucose) on Meal Test at 1 Year||1 year||||||
146088|NCT00420511|Secondary|Fasting Blood Glucose at 48 Weeks||48 weeks|||mmol/l||Inter-Quartile Range|Median
146089|NCT00420511|Secondary|Insulinogenic Index Divided by HOMA-IR at 48 Weeks|Insulinogenic index was calculated as the incremental change in insulin from 0 to 30 minutes divided by the incremental change in glucose over the same period of time. Insulinogenic index divided by HOMA-IR provides an additional measure of beta-cell function. A higher value indicates better beta-cell function|48 weeks|||index of beta-cell function||Inter-Quartile Range|Median
146090|NCT00420511|Primary|Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR|Area-under-the-C-peptide-curve (AUCCpep) and area-under-the-glucose-curve (AUCgluc) from 0 to 240 minutes during meal tests were calculated using the trapezoidal rule. Insulin resistance was assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). Beta-cell function was assessed using the ratio of total AUCCpep to AUCgluc divided by HOMA-IR (AUCCpep/gluc/HOMA-IR), a measure of insulin secretion in the context of ambient insulin sensitivity, analogous to the disposition index and adaptation index. Higher AUCCpep/gluc/HOMA-IR is indicative of better beta-cell function.|48 weeks|||index of beta-cell function||Inter-Quartile Range|Median
146091|NCT00418665|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions during the treatment period|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
146092|NCT00418665|Secondary|Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period and post-treatment follow-up (up to 21 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
146093|NCT00418665|Secondary|Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia|Treatment period (up to 16 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
146094|NCT00418665|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.|Treatment period through interim follow-up visit (up to 16 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
146095|NCT00418574|Secondary|Time Course of Immunoresponse|Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).|at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)|Participants who received abagovomab (evaluable population)and have baseline serum sample: 576 at baseline; 538 at week 10 after first dose intake; 449 at the final study visit||ng/ml||Full Range|Median
146136|NCT00418522|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 26|Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting plasma glucose at Baseline and Week 26: inhaled human insulin n=202, insulin glargine n=189.||mg/dL||Standard Deviation|Mean
146096|NCT00418574|Secondary|Safety|"Safety was analyzed in all patients who received at least 1 dose administration.~Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed."|Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose|Safety population (i.e. All randomized patients who received at least one dose treatment administration)||participants|||Number
146097|NCT00418574|Secondary|Overall Survival|2 years survival rate|2 years|intention to treat (ITT) population (i.e. all randomized patients)||Percentage of participants|||Number
146098|NCT00418574|Primary|Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)|The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.|Every 12 weeks up to recurrence or up to 3 months after last administered dose|intention to treat (ITT) population (i.e. all randomized patients)||days||95% Confidence Interval|Median
146099|NCT00418561|Other Pre-specified|Physical Examination Results|Physical examination included general appearance, skin, head, ears, eyes, nose and throat, lymph nodes, heart, lungs, abdomen, extremities/joints, hip, neurological, mental status and, if appropriate, breasts, external genitalia, pelvic and rectal, and in addition weight, height and head circumference were recorded.|Baseline up to Week 26|Physical examination results were not summarized since data were collected in participant’s listing only as planned.|||||
146100|NCT00418561|Primary|Arylsulfatase A (ASA) Activity in Leukocytes||Pre-dose and post-dose at 24 hours on Day 0 and at Weeks 8 and 26|Data were not available to report as ASA activity in leukocytes was presented graphically, as per planned analysis.|||||
146101|NCT00418561|Primary|Maximum Plasma Drug Concentration (Cmax) of Recombinant Human Arylsulphatase A (rhASA)||Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours on Day 0, 40 minutes post-dose at Week 4, Pre-dose and post-dose at 20, 40, 90 minutes, 3, 6 and 8 hours at Week 8|Due to quick disappearance of rhASA from plasma, rhASA levels were not possible to report.|||||
146102|NCT00418561|Other Pre-specified|Change From Baseline in Amplitude at Week 26|Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; APB=abductor pollicis brevis; EDB=extensor digitorum brevis.|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||millivolts||Standard Deviation|Mean
146103|NCT00418561|Other Pre-specified|Change From Baseline in Neurofilament Proteins (NFP), Glial Fibrillary Acidic Protein (GFAP) and Tauprotein in Cerebrospinal Fluid (CSF) at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||nanogram/milliliter||Standard Deviation|Mean
146104|NCT00418561|Other Pre-specified|Change From Baseline in Chitotriosidase at Week 26||Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||nanomole/hour/milliliter||Standard Deviation|Mean
146105|NCT00418561|Other Pre-specified|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings|Abnormal ECG findings were considered as clinically significant at the discretion of investigator.|Baseline up to Week 26|ITT||participants|||Number
146106|NCT00418561|Other Pre-specified|Number of Participants With Abnormal Findings in Urine Analysis|The parameters analyzed in urine were albumin/protein, glucose, leucocytes, acetoacetate/ketones, nitrite and pH. Urine analysis findings were considered abnormal as judged by the investigator.|Baseline up to Week 26|ITT||participants|||Number
146107|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Hematology|"Number of participants with at least 1 shift from baseline to Week 26 are reported.~Abbreviations: Abs=Absolute count; ERCS=Erythrocytes; MCHC=Mean corpuscular hemoglobin concentration; MCH=Mean cell hemoglobin."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."||participants|||Number
146108|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Genotyping|"Number of participants with at least 1 shift from baseline to Week 26 are reported.~Abbreviations: CSF=Cerebrospinal fluid; NFP=Neurofilament proteins."|Baseline up to Week 26|"ITT. The number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome. Here, N signifies the number of participants who were evaluable for the respective category."||participants|||Number
146109|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Coagulation|Number of participants with at least 1 shift from baseline to Week 26 are reported. The shift reported below for Cohort 1 was from low level at baseline to low level at Week 26.|Baseline up to Week 26|ITT. Data for Cohorts 2 and 3 were not reported since there were no participants with shift from baseline to Week 26 in coagulation evaluations.||participants|||Number
146110|NCT00418561|Other Pre-specified|Number of Participants With Shift From Baseline to Week 26 in Clinical Laboratory Evaluations: Biochemistry|"Number of participants with at least 1 shift from baseline to Week 26, are reported.~Abbreviations: ALT=Alanine transaminase; CK=Creatine kinase; AP=Amyloid P component; LDH=Lactate dehydrogenase."|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.||participants|||Number
146111|NCT00418561|Secondary|Change From Baseline in Paediatric Evaluation of Disability Inventory (PEDI) Scores at Week 26|PEDI is used for the clinical evaluation of functional capabilities, performance and changes in functional skills in children with disabilities. It consisted of 20 items scored on a scale from 0 (total assistance) to 5 (independent). Total score ranged from 0-100 with higher scores indicating better functioning. None, child, rehab, extensive are items in 3 domains (self-care, mobility and social functioning).|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||units on a scale||Standard Deviation|Mean
146137|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26|Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 8.0% at Week 26: inhaled human insulin n=162, insulin glargine n=158.||percentage of participants|||Number
146112|NCT00418561|Secondary|Number of Participants With Shift From Baseline to Week 26 in Magnetic Resonance Imaging (MRI)-Loes Scores|Loes scoring system is used to grade the demyelinating abnormalities on brain MRI. A total of 17 locations of the brain were scored from 0 (normal appearance) to 2 (dense appearance). The total score ranged from 0 to 34 with a score of 14 or greater being considered severe. Number of participants with any shift of score between 0 to 2 for each of the 17 locations (Parieto Occipital [PO]-Periventricular [P], Central [C], Subcortical [Sc]; Anterior Temporal [AT]-P, C, Sc; Frontal [F]-P, C, Sc; Corpus Callosum [CC]-Splenium [S], Genus [G]; Projection Fibers [PF]-Capsular interna [CI] ant, CI post, Brainstem [B]; Cerebellum [Cb]-Cortex, Atrophy; Basal Ganglia [BG]-BG, Thalamus [T]; Cerebral Atrophy [CA]-CA), are only reported.|Baseline up to Week 26|ITT. Here, number of participants analyzed in the Cohort 2 are the participants evaluable for this outcome.||participants|||Number
146113|NCT00418561|Secondary|Number of Participants Who Had Undergone Nerve Biopsy and Had a Normal Nerve at Both Baseline and Week 26||Baseline, Week 26|ITT.||participants|||Number
146114|NCT00418561|Secondary|Change From Baseline in Nerve Conduction Velocity at Week 26|"An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction and units are expressed in meters per second.~Abbreviations: MN=Median Nerve; PN=Peroneal Nerve; SN=Sural Nerve; Dig.=Digit; FH=fibular hemimelia; L LM=left lateral medial; R LM=right lateral medial; MC=medial collateral."|Baseline, Week 26|"ITT. Here, N signifies the number of participants who were evaluable for the respective category."||meters per second||Standard Deviation|Mean
146115|NCT00418561|Primary|Change From Baseline in Mullen’s Scales of Early Learning at Week 26|Mullen's Scales of Early Learning is used to assess performance and learning ability in young children. The scale consisted of 144 items that had specific scoring criteria for each item. The scores were converted to T-scores with a decrease in score indicating worsening of disease. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT||percent (%) change||95% Confidence Interval|Mean
146116|NCT00418561|Primary|Number of Participants With Shift From Baseline to Week 26 in Sulfatide Levels in Urine|Number of participants with shifts between negative (value=0) and positive (value=1) values in urine sulfatide levels from baseline at Week 26 is reported.|Baseline up to Week 26|ITT. Here, the number of participants analyzed are the participants evaluable for this outcome.||participants|||Number
146117|NCT00418561|Primary|Change From Baseline in Cerebrospinal Fluid (CSF) Sulfatide at Week 26|Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT||percent (%) change||95% Confidence Interval|Mean
146118|NCT00418561|Primary|Change From Baseline in Gross Motor Function Measure (GMFM) at Week 26|GMFM was measured using GMFM-88 item scores and summed to calculate a total GMFM-88 score. For each GMFM-88 item, the score was between 0 (minimal) to 3 (maximum). The total GMFM-88 score was between 0 (minimal) and 264 (maximum). The decrease in GMFM score over time indicates worsening of disease over time. Relative change from baseline at Week 26 was calculated as percentage change from baseline divided by the age-difference in months between first and last visit. Adjusted mean and 95 percent (%) confidence intervals were reported.|Baseline, Week 26|ITT||percent (%) change||95% Confidence Interval|Mean
146119|NCT00418561|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship. TEAEs were AEs occurred after study drug administration that were absent before treatment or that worsened relative to pre-treatment state, up to Week 28 until evaluation (when last cohort had 26-week evaluation and data management performed within 4 weeks) completed.|From study drug administration up to Week 28|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.||participants|||Number
146120|NCT00418522|Other Pre-specified|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Using the FAS yielded supplemental analyses for the primary efficacy endpoint.||percent||Standard Deviation|Mean
146121|NCT00418522|Secondary|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire|Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.|Baseline, Week 26||||||
146122|NCT00418522|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 26|BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with BMI measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.||kg/m2||Standard Deviation|Mean
146123|NCT00418522|Secondary|Change From Baseline in Body Weight at Week 26|Body weight value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with body weight measurements at Baseline and Week 26: inhaled human insulin n=192, insulin glargine n=183.||kg||Standard Deviation|Mean
146124|NCT00418522|Secondary|Number of Nocturnal Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug.||events|||Number
149393|NCT00393705|Secondary|Change From Baseline in Weight at 16 Week Endpoint||Baseline, 16 weeks|Number of patients who received at least one dose of study drug and had at least one post-baseline weight value at week 16.||kilograms (kg)||Standard Deviation|Mean
146125|NCT00418522|Secondary|Crude Hypoglycemic Event Rate|crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||events / subject-months|||Number
146126|NCT00418522|Secondary|Number of Total Subject Months of Treatment|Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||subject months|||Number
146127|NCT00418522|Secondary|Number of Total Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||events|||Number
146128|NCT00418522|Secondary|Number of Subjects With Hypoglycemic Events|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.|Months 1 to 7|Safety population=all subjects who took at least 1 dose of study drug. Number of subjects with at least 1 hypoglycemic event during the course of the study that were evaluable at the specified month: n=inhaled human insulin, insulin glargine.||participants|||Number
146129|NCT00418522|Secondary|Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26|SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.||mg/dL||Standard Deviation|Mean
146130|NCT00418522|Secondary|Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26|24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS-CGMS=all subjects with at least 1 study drug dose, at least 1 post-baseline measurement, and who participated in a 24-hour CGMS substudy. LOCF imputed missing data with any post-baseline visit. Number of subjects who participated in the substudy with 24-hour CGMS values at Baseline and Week 26: inhaled human insulin n=2, insulin glargine n=8.||mg/dL||Standard Deviation|Mean
146131|NCT00418522|Secondary|Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26|CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (adiponectin and ApoB) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/mL||Standard Deviation|Mean
146132|NCT00418522|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26|CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with CV biomarker data (hs-CRP, leptin, and spot urine microalbumin) at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/L||Standard Deviation|Mean
146133|NCT00418522|Secondary|Change From Baseline in Lipids at Week 26|Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with lipids data at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/dL||Standard Deviation|Mean
146134|NCT00418522|Secondary|Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26|Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS = all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with postprandial blood glucose measurements as measured by 8-point profiles at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/dL||Standard Deviation|Mean
146135|NCT00418522|Secondary|Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26|Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with fasting and postprandial blood glucose measurements determined by standardized meal tolerance tests at Baseline and Week 26: n=inhaled human insulin, insulin glargine.||mg/dL||Standard Deviation|Mean
149406|NCT00393510|Secondary|Time of Ulcer Healing|Time taken for maturation of granulation to enable skin grafting.|24 week|||Weeks||Standard Deviation|Mean
146138|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 7.0% at Week 26: inhaled human insulin n=127, insulin glargine n=90.||percentage of participants|||Number
146139|NCT00418522|Secondary|Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26|Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.|Week 26|FAS=all subjects who took at least 1 dose of study drug and had at least 1 post-baseline measurement. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c < 6.5% at Week 26: inhaled human insulin n=72, insulin glargine n=42.||percentage of participants|||Number
146140|NCT00418522|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population|HbA1c lab value: Change = value at Week 26 minus value at Baseline.|Baseline, Week 26|Per protocol (PP)=Full Analysis Set (FAS) subjects (i.e., had >=1 study drug dose and >=1 post-baseline measurement) with >=12 weeks treatment and no major protocol violation. LOCF imputed missing data with any post-baseline visit. Number of subjects with HbA1c values at Baseline and Week 26: inhaled human insulin n=154, insulin glargine n=157.||percent||Standard Deviation|Mean
146141|NCT00420420|Other Pre-specified|Baseline: Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Deviation|Mean
146142|NCT00420420|Other Pre-specified|Baseline: ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Deviation|Mean
146143|NCT00420420|Other Pre-specified|Baseline: Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Deviation|Mean
146144|NCT00420420|Primary|Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score|The ADAS-Cog, scored as the total score of 11 tasks including mazes was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the ADAS-Cog total score. The ADAS-Cog total score ranges from 0 to 70, with higher total scores indicating more impairment. Lower scores (and negative changes from Baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Error|Mean
146145|NCT00420420|Secondary|Week 4 Change From Baseline in Cognition Summary Score (CSS)|The CSS was used to evaluate cognitive function as measured by the mean change from Baseline to Week 4 in the CSS total score. The CSS was derived from the correct sequence percentage from the Route Test and 6 of the CNTB scores (the CSS was scored as the mean of the 7 scores). CSS scores can range from 0 to 100, higher scores (and positive changes from baseline) indicate better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Error|Mean
146146|NCT00420420|Primary|Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.|The CNTB was used to evaluate cognitive function, as measured by the mean change from Baseline to Week 4 in the short CNTB summary score. The short CNTB summary score was scored as the mean score across 5 modules: Word List Learning-Selective Reminding, Word List Learning-Delayed Recall, Simple Reaction Time, Choice Reaction Time, and Visual Memory subtests. The short CNTB summary score ranges from 0 to 100, with higher scores (and positive changes from baseline) indicating better performance.|Baseline and Week 4|Full Analysis Set: All patients who were randomized, took at least one dose of study medication, and had at least one efficacy measurement at either Baseline, Week 2 or Week 4. Patients were counted in the treatment group to which they were randomized.||units on a scale||Standard Error|Mean
146147|NCT00420407|Secondary|Secondary Objective is to Better Understand the Efficacy of Novel Endpoints of Resuscitation in the Management of Shock and the Ability of These Monitors to Predict Outcome After Trauma.||28 days||||||
146148|NCT00420407|Primary|The Primary Endpoint of This Study Will be Day 30 Mortality.||30 days|||Participants|||Number
146149|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 130 mmHg||mmHg||Standard Deviation|Mean
147034|NCT00412113|Secondary|Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)|Mean change at observation minus mean baseline.|Week 6, baseline|Full analysis set: all randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mmHg||Standard Deviation|Mean
146151|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 120 mmHg||mmHg||Standard Deviation|Mean
146152|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 116 mmHg||mmHg||Standard Deviation|Mean
146153|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)|Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.|Baseline to Week 8|FAS population, for patients with baseline 24-hour ABPM means > 112 mmHg||mmHg||Standard Deviation|Mean
146154|NCT00420342|Secondary|Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8|Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported.|8 weeks plus 3 days|FAS subjects from the one site which performed the sodium sensitivity analysis||participants|||Number
146155|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements|Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values||mmHg||Standard Error|Median
146156|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements|Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline; number of subjects analyzed was 27 in the 0.5mg DRSP group for nighttime values||mmHg||Standard Error|Mean
146157|NCT00420342|Secondary|Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough|Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline||mmHg||Standard Error|Mean
146158|NCT00420342|Secondary|Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements|The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.|Baseline to Week 8|Primary analysis used FAS; no imputation methods used; patients with missing data had no BP values after baseline||mmHg||Standard Error|Mean
146159|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis was Per Protocol Population (PP); no imputation methods used; patients with missing data had no BP values after baseline.||mmHg||Standard Error|Mean
146160|NCT00420342|Primary|Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population|The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.|Baseline to Week 8|Primary analysis used Full Analysis Set (FAS), which follows ITT principles; no imputation methods used; patients with missing data had no Blood Pressure (BP) values after baseline||mmHg||Standard Error|Mean
146161|NCT00420303|Primary|Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12|The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Baseline and 12 weeks|All randomized patients who received at least 1 dose of test article.||units on scale||Standard Deviation|Mean
146162|NCT00420303|Secondary|Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity|A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad.|12 weeks|All randomized patients who received at least 1 dose of test article.||patients|||Number
146163|NCT00420303|Primary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12|PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).|12 weeks|All randomized patients who received at least 1 dose of test article. Last observation carried forward (LOCF)||mm||Standard Deviation|Mean
146164|NCT00420290|Secondary|Lean Body Mass (LBM)|LBM is a measurement of body composition in terms of lean body mass as determined using Dual Energy X-ray Absorptiometry (DEXA) performed 1 to 2 hours after dialysis.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||kg||Standard Deviation|Mean
146165|NCT00420290|Secondary|Serum Albumin|Albumin is a sensitive laboratory assay for serum levels of albumin, which is a biomarker of nutrition.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||g/dl||Standard Deviation|Mean
146167|NCT00420290|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interlukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||pg/ml||Standard Deviation|Mean
146168|NCT00420290|Primary|High Sensitivity C-reactive Protein (hsCRP)|hsCRP is a sensitive laboratory assay for serum levels of C-reactive protein, which is a biomarker of inflammation.|month 1|The number of participants for analysis was based on those subjects who completed the 4-week study. The analysis was per protocol.||mg/dl||Standard Deviation|Mean
146169|NCT00420238|Secondary|Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.||percent of participants|||Number
146170|NCT00420238|Secondary|Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12|Subjects were asked how their pain had been during the last 48 hours compared to baseline. Those subjects that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviation: Mod = moderately.||percent of participants|||Number
146171|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 14, Week 18, Week 24|Open-label population. In the case of missing data, no replacement or imputation method was performed.||percent of participants|||Number
146172|NCT00420238|Secondary|Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12|"Percent of subjects reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, subjects who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||percent of participants|||Number
146173|NCT00420238|Secondary|Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24|Percent of participants with normal (<6 milligrams per liter) and abnormal (>= 6 milligrams per liter) C-Reactive Protein.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of participants|||Number
146174|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24|Change from baseline in C-reactive Protein (CRP).|Week 14, Week 18, Week 24|Open-label population; LOCF.||milligrams per liter||95% Confidence Interval|Mean
146175|NCT00420238|Secondary|Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12|CRP is a marker of inflammation. A higher level is consistent with inflammation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. LOCF.||milligrams per liter||95% Confidence Interval|Least Squares Mean
146176|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the C-reactive Protein curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||milligrams per liter||95% Confidence Interval|Least Squares Mean
146177|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 14, Week 18, Week 24|Open-label population; LOCF.||millimeters per hour||95% Confidence Interval|Mean
146178|NCT00420238|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||millimeters per hour||95% Confidence Interval|Least Squares Mean
146179|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Erythrocyte Sedimentation Rate curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters per hour||95% Confidence Interval|Least Squares Mean
146180|NCT00420238|Secondary|Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) due to AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146181|NCT00420238|Secondary|Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12|Subject evaluation of level of difficulty to perform daily physical activities and/or kinesitherapy for ankylosing spondylitis (AS) because of AS using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=easy to 100=impossible. Subgroup of subjects who responded that they were able to perform daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = subgroup of subjects who reported performing daily physical activities and/or kinesitherapy for their ankylosing spondylitis at each visit (Week 2 through Week 12).||units on scale||95% Confidence Interval|Least Squares Mean
146182|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters (cm).|Week 14, Week 18, Week 24|Open-label population; LOCF.||centimeters||95% Confidence Interval|Mean
146183|NCT00420238|Secondary|Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12|Measurement and remeasurement of standing maximal inspiration; chest circumference at nipple line or at 4th intercostal space in centimeters.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||centimeters||95% Confidence Interval|Least Squares Mean
146184|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12|Normalized net incremental area under the curve (AUC) = area between baseline and the Chest Expansion Test curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||centimeters||95% Confidence Interval|Least Squares Mean
146185|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146186|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of the distance between the medial malleoli when subject is lying supine with knees and feet straight up with legs separated as far as possible. Measurement of two attempts. Mean of ordinal scores from 0: >= 120 cm, to 9: 30 to 39.9 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146187|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146188|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters of the distance between marks originally placed while the subject was standing erect 10 centimeters (cm) above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was remeasured with subject maximally bend forward, knees fully extended, with spine in full flexion. Measurement of two attempts. Mean of ordinal scores from 1: 5.7 to 6.3 cm, to 10: <=0.7 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146189|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146190|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12|Measurement in centimters (cm) of distance between subject's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attemting to keep shoulders in same place (flexion position). Measurement of two attempts on each side (right and left). Mean of ordinal scores from 0: >=20 cm to 10: <=1.2 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146191|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two tries on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146216|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
146192|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12|Measurement in centimeters (cm) of distance between the tragus and wall from right and left side while subject is standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in neutral position. Measurement of two attempts on right and left sides. Mean of ordinal scores from 0: <= 10 cm to 10: >= 37 cm.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||centimeters||95% Confidence Interval|Mean
146193|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24|Cervical rotation: measurement in degree to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed.||units on scale||95% Confidence Interval|Mean
146194|NCT00420238|Secondary|Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12|Cervical rotation: measurement of degrees to which the subjects could turn their heads as far as possible to the right and then to the left. Mean of ordinal scores from 0: >= 85 degrees to 10: <= 8.5 degrees.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. In the case of missing data, no replacement or imputation method was performed.||units on scale||95% Confidence Interval|Mean
146195|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober’s test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146196|NCT00420238|Secondary|Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Higher score = greater reduction in spinal mobility.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
146197|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12|BASMI was composed of 5 measures; each measure scored 0-2 (0=normal mobility, 2=severe reduction); final score range: 0 to 10. Normalized net incremental area under the curve (AUC) = area between baseline and the BASMI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||millimeters||95% Confidence Interval|Least Squares Mean
146198|NCT00420238|Secondary|Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)||Baseline, Week 12|mITT; N=number of subjects with evaluable data. In the case of missing data, no replacement or imputation method was performed.||percent||95% Confidence Interval|Least Squares Mean
146199|NCT00420238|Secondary|Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)||Baseline, Week 12|mITT. In the case of missing data, no replacement or imputation method was performed.||liters||95% Confidence Interval|Least Squares Mean
146200|NCT00420238|Secondary|Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12|Subject evaluation of the effect of their disease on well-being over the last week using a using a 100 millimeter Visual Anaog Scale; range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Mean
146201|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very important.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146202|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12|Subject assessment of the effect of their disease on well-being over last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=very important.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||units on scale||95% Confidence Interval|Least Squares Mean
146203|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12|BAS-G was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0=none to 100=very important. Normalized net incremental area under the curve (AUC) = area between baseline and the BAS-G curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
146204|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24|BASDAI subject rated components over last 48 hours using a 100 millimeter Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3)Overall level of pain/swelling in joints other than neck,back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening.|Week 14, Week 18, Week 24|Open-label population; in case of missing data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.||units on scale||95% Confidence Interval|Mean
146205|NCT00420238|Secondary|Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12|BASDAI subject rated components over last 48 hours using 100 mm Visual Analog Scale; components 1-5: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3) Overall level of pain/swelling in joints other than neck, back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening, and morning stiffness subscale.|Week 2, Week 4, Week 8, Week 12|mITT; in case of mising data, no replacement or imputation method was performed. Abbreviations: C=component, AS=Ankylosing Spondylitis.||units on scale||95% Confidence Interval|Mean
146206|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis (AS) in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146207|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12|BASDAI is a validated self assessment tool used to determine disease activity in patients with ankylosing spondylitis in the last 48 hours. Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on a scale||95% Confidence Interval|Least Squares Mean
146208|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24|Subject rating of last 48 hours, 100 mm Visual Analog Scale; range 0=easy to 100=impossible: 1) Putting on socks/tights without (w/o) help; 2) Bending forward from waist to pickup pen from floor w/o aid; 3) Reaching to high shelf w/o aid; 4) Getting out of armless dining room chair w/o using hands/other help; 5) Getting up off floor w/o help from lying on back; 6) Standing unsupported 10 minutes w/o discomfort; 7) Climbing 12-15 steps w/o handrail or walking aid; 8) Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Week 14, Week 18, Week 24|Open-label population; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C=component (number), Act=Activities.||units on a scale||95% Confidence Interval|Mean
146209|NCT00420238|Secondary|Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12|Subject rating of last 48 hours, 100 millimeter Visual Analog Scale; range 0=easy to 100=impossible: 1)Putting on socks/tights without (w/o) help; 2)Bending forward from waist to pickup pen from floor w/o aid; 3)Reaching to high shelf w/o aid; 4)Getting out of armless dining room chair w/o using hands/other help; 5)Getting up off floor w/o help from lying on back; 6)Standing unsupported 10 minutes w/o discomfort; 7)Climbing 12-15 steps w/o handrail or walking aid; 8)Looking over shoulder w/o turning body; 9) Doing physically demanding activities; 10) Doing full days activities (home or work).|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; in the case of missing data, no replacement or imputation method was performed. Abbreviations: C = component (number), Act = Activities.||units on a scale||95% Confidence Interval|Mean
146210|NCT00420238|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12|BASFI is a validated self assessment tool that determines the degree of functional limitation in ankylosing spondylitis (AS) patients using a 100 millimeter (mm) Visual Analog Scale (VAS) measuring level of ability with activities in the last 48 hours; range: 0=easy to 100=impossible. Higher score = greater limitation.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||units on scale||95% Confidence Interval|Least Squares Mean
146211|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12|BASFI was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = easy to 100 = impossible. Normalized net incremental area under the curve (AUC) = area between baseline and the BASFI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
146212|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 14, 18, 24|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146213|NCT00420238|Secondary|Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12|Subject assessment of total back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
146214|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12|Total back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Total Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
146215|NCT00420238|Secondary|Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24|Subject assessment of nocturnal back pain due to ankylosing spondylitis during the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=none to 100=extreme.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146217|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12|Nocturnal back pain was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0 = none to 100 = extreme. Normalized net incremental area under the curve (AUC) = area between baseline and the Nocturnal Back Pain curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N=number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
146218|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146219|NCT00420238|Secondary|Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12|Physician global assessment of all the ways ankylosing spondylitis has affected patient during the last 48 hours. 100 millimeter (mm) Visual Analog Scale (VAS); range: 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||units on scale||95% Confidence Interval|Least Squares Mean
146220|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC) = area between baseline and the Physician Global Assessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N= number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
146221|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Week 14, Week 18, Week 24|Open-label population; LOCF.||units on scale||95% Confidence Interval|Mean
146222|NCT00420238|Secondary|Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12|Patient global assessment of all the ways ankylosing spondylitis affected them in the last 48 hours using a 100 millimeter (mm) Visual Analog Scale (VAS); range 0=very good to 100=very bad.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||units on scale||95% Confidence Interval|Least Squares Mean
146223|NCT00420238|Secondary|Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12|PGA was measured using a 100 millimeter Visual Analog Scale (VAS) ranging from 0 = very good to 100 = very bad. Normalized net incremental area under the curve (AUC)=area between baseline and the Patient Global Asessment curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all area below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF. N = number of subjects with evaluable data.||millimeters||95% Confidence Interval|Least Squares Mean
146224|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of participants|||Number
146225|NCT00420238|Secondary|Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12|Partial remission defined as a score of <20 millimeters (mm) on a scale of 0 to 100 mm in each of 4 domains: Visual Analog Scale (VAS) patient global assessment, VAS pain score (Total Back Pain), Bath Ankylosing Spondylitis Functional Index (BASFI) score, and Bath Ankylosing Spondylitis Disease Activities Index (BASDAI)-mean of two morning stiffness-related VAS scores. A negative score indicates an improvement in disease activity and a positive score indicates worsening.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
146226|NCT00420238|Secondary|Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of participants|||Number
146227|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
146228|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population; LOCF.||percent of particpants|||Number
149407|NCT00393510|Secondary|Tumour Necrosis Factor-alpha Levels in Serum|The state of inflammation at baseline and at 4 weeks after treatment. TNF-alpha are in value of serum level.|Baseline and 4 week|||pg/mL||Standard Deviation|Mean
146229|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (versus baseline) and an absolute (net) change ≥ 20 units on a 0-100 scale (high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
146230|NCT00420238|Secondary|Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function, and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 units (millimeters) on a 0-100 scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >=10 mm) in remaining domain.|Week 14, Week 18, Week 24|Open-label population: all subjects who received at least 1 dose of open test article (Etanercept). LOCF.||percent of participants|||Number
146231|NCT00420238|Secondary|Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients; 4 domains: patient global assessment of disease activity, pain, function,and inflammation. ASAS 20 = 20% improvement (versus baseline) and an absolute change (net improvement) ≥ 10 millimeters (mm) on a 0-100 mm scale (100=high disease activity) for ≥ 3 domains, and no worsening (absence of deterioration by >=20% and by >= 10 mm) in remaining domain.|Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
146232|NCT00420238|Secondary|Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|BASDAI subject assessment of discomfort, pain and fatigue was measured using a 100 millimeter Visual Analog Scale (VAS); range: 0=none to 100=very severe. BASDAI 50 response defined as at least a 50 percent (%) improvement (decrease) from baseline to observation (last observation carried forward) in the BASDAI. Baseline score minus score at observation divided by Baseline score * 100 = >=50%.|Baseline, Week 2, Week 4, Week 8, Week 12|mITT; LOCF.||percent of participants|||Number
146233|NCT00420238|Primary|Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12|BASDAI subject asessment of discomfort, pain and fatigue measured using a 100 millimeter Visual Analog Scale; range: 0=none to 100=very severe. Normalized net incremental area under the curve (AUC) = area between baseline and the BASDAI curve as a function of time (randomization to Week 12); computed using the linear trapezoidal method. All areas above baseline and under the curve are positive and all areas below baseline and above the curve are negative. Net incremental AUC = sum of these areas; this result was then divided by the study duration of the patients; negative value = improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|Modified Intent-To-Treat (mITT) population: includes all randomized subjects who received at least 1 dose of blinded study drug. Last observation carried forward (LOCF).||millimeters||95% Confidence Interval|Least Squares Mean
146234|NCT00420212|Secondary|Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)|The EDSS is based on a standardized neurological examination and focuses on symptoms that commonly occur in MS. EDSS scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or a ≥1.5 point increase in subjects with a baseline EDSS = 0, and required that the increase from baseline was confirmed ≥12 weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution.|2 years|The analysis population consisted of the ITT population (all subjects who were randomized and received at least 1 dose of study medication) who had a baseline EDSS assessment. Analysis were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.||Proportion of participants|||Number
146235|NCT00420212|Secondary|Annualized Relapse Rate|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The adjusted annualized relapse rate was calculated from a negative binomial regression model, adjusted for baseline EDSS (≤ 2.0 vs. >2.0), age (<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.|2 years|The ITT population was defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Relapses per year||95% Confidence Interval|Mean
146236|NCT00420212|Secondary|Number of Subjects With Gadolinium (Gd)-Enhancing Lesions|"Note: This outcome measure represents the categorical analysis for the previously listed secondary outcome measure Number of Gadolinium-enhancing T1-weighted lesions"|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption||Number of subjects|||Number
146237|NCT00420212|Secondary|Number of Gadolinium-enhancing T1-weighted Lesions|The number of Gd-enhancing lesions was assessed using brain MRI scans following administration of gadolinium, a contrast agent. The mean number of Gd-enhancing lesions at 2 years was the average of the number of lesions at 2 years in a treatment group.|2 years|Of the 540 subjects included in the MRI cohort, 469 (165 placebo,152 BG00012 BID,152 BG00012 TID) had post-baseline Gd-enhancing lesion data & were included in the analysis. Missing data before the use of alternative MS medications & visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption||Number of lesions||Standard Deviation|Mean
146305|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic ventricular (VE) beats – number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.||Participants|||Number
149408|NCT00393510|Primary|Number of Participants With Limb Salvage|The number of successful limb rescued (without amputation).|24 weeks|||Participants|||Number
146238|NCT00420212|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 lesion count were calculated from a negative binomial regression model adjusted for region and baselineT2 lesion volume|2 years|Of the 540 subjects included in the MRI cohort, 469 subjects (165 placebo, 152 BG00012 BID, 152 BG00012 TID) had post-baseline T2 data and were included in the analysis. Missing data before the use of alternative MS medications and visits after patients switched to alternative MS medications were imputed with the use of a constant rate assumption.||Number of lesions||95% Confidence Interval|Mean
146239|NCT00420212|Primary|Proportion of Subjects Relapsed|A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.|2 years|The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study medication. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.||Proportion of subjects,confirmed relapse|||Number
146240|NCT00420199|Secondary|Double-blind Period: Number of Participants With Positive Antibodies to Abatacept by Electrochemiluminescence (ECL) Assay|On-Rx=on treatment; post-Rx=post treatment. ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1.|Day 1 to Day 113|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146241|NCT00420199|Secondary|Double-blind Period:Number of Participants With Significantly Abnormal Changes in Vital Signs|Vital signs, which included blood pressure, heart rate, respiration, and temperature, were monitored predose and 1 hour after start of infusion. Changes in vital signs were determined to be significantly abnormal at the discretion of the investigator but were generally those that either exceeded, or failed to reach, normal parameters. Normal vital sign parameter ranges varied by site.|Days 1, 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146242|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis score=Follow-up synovitis score-baseline synovitis score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and who had wrist synovitis assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
146243|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Other Chemistries and Urinalysis Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL-baseline. Marked abnormality c: serum glucose:<65 mg/dL/>220 mg/dL; fasting serum glucose: <0.8* LLN/>1.5* ULN, or if BL<LLN, use 0.8*BL or >ULN, or if BL>ULN, use >2.0*BL or <LLN; total protein: <0.9*LLN/>1.1* ULN; albumin: <0.9*LLN,or if BL<LLN, use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN, use >2*BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, red blood cells, white blood cells):Use ≥2 when BL value missing or value ≥4,or when predose=0 or 0.5. Use ≥3 when predose=1. Use ≥4 when predose=2 or 3|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146244|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Electrolytes Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Marked abnormality: Sodium: <0.95*LLN/>1.05*ULN,or if BL<LLN, use 0.95*BL or >ULN,or if BL>ULN, use>1.05*BL or <LLN. Potassium: <0.9*LLN/>1.1* ULN,or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Chloride: <0.9*LLN/>1.1*ULN, or if BL<LLN, use 0.9*BL or >ULN, or if BL>ULN, use>1.1*BL or <LLN. Calcium: <0.8*LLN/>1.2*ULN, or if BL<LLN, use 0.75*BL or >ULN, or if BL>ULN, use>1.25*BL or <LLN. Phosphorous: <0.75*LLN/>1.25*ULN, or if BL<LLN, use 0.67*BL or >ULN, or if BL>ULN, use>1.33*BL or <LLN.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146245|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results for Liver and Kidney Function Meeting Criteria for Marked Abnormality|ULN=upper limit of normal; BL=baseline. Marked abnormality criteria: Alkaline phosphatase: >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase: >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase: >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase: >2*ULN, or if BL>ULN, use >3*BL; Bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen: >2*BL; creatinine: >1.5*BL.|From Day 1 to Day 113, and including up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146246|NCT00420199|Secondary|Double-blind Period: Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality|BL=baseline; LLN=lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL. Hematocrit: <0.75*BL. Erythrocytes: <0.75*BL. Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3. Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN. Neutrophils+bands: <1.0*10^3 c/uL. Eosinophils: >0.750*10^3 c/uL. Basophils: > 400 mm^3. Monocytes: >2000 mm^3. Lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146247|NCT00420199|Secondary|Double-blind Period: Number of Participants With Peri-infusional AEs of Special Interest|Peri-infusional AEs are AEs occurring during the first 24 hours after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events, Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146248|NCT00420199|Secondary|Double-blind Period: Number of Participants With Acute Infusional AEs of Special Interest|Acute infusional AEs are AEs with onset during the first hour after the start of study drug infusion. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs considered possibly, probably, or certainly related to study treatment were graded according to Common Terminology Criteria for Adverse Events ,Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146249|NCT00420199|Secondary|Double-blind Period: Number of Participants With Infections/Infestations of Special Interest|Infections/Infestations of Special Interest are AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146250|NCT00420199|Secondary|Double-blind Period: Number of Participants With AEs of Special Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including serious, opportunistic, and all other infections; autoimmune disorders; neoplasms; acute infusional AEs (prespecified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (prespecified AEs occurring within 24 hours of start of infusion).|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146251|NCT00420199|Secondary|Double-blind Period: Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|From Day 1 to Day 113, and up to 56 days post last dose of double-blind period, or start of first dose of open-label period|All randomized participants who received at least 1 dose of study medication.||participants|||Number
146252|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Marker of Synovial Tissue Metabolism (Creatinine-corrected Urinary Glucosyl-Galactosyl-Pyridinoline [UGGPC])|Glucosyl-galactosyl-pyridinoline (Glc-Gal-PYD) is a specific biochemical marker reflecting the degradation of the synovial tissue membrane. It is a glycosylated derivative of the collagen crosslink pyridinoline, and it is present in significant amounts only in the synovial membrane; it is absent from bone and present in minutes amounts in cartilage and other soft tissues. Increased urinary levels of Glc-Gal-PYD have been found in early and long-standing rheumatoid arthritis, high levels being associated with rapid destruction.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
146253|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in a Systemic Marker of Cartilage Degradation (Creatinine-corrected Urinary Carboxyterminal Crosslinking Telopeptide of Type II Collagen [UCTX2C])|Urinary CTX-II is a biochemical marker of type II collagen breakdown. In participants with early rheumatoid arthritis, increased levels of CTX-II can be predictive of rapid radiographic progression over periods of 1 to 5 years. These markers of cartilage destruction can predict progression of joint damage, independent of clinical and biologic indices of disease activity and baseline joint damage.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
146254|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Destruction (Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen [CTX-I] and Serum Pyridinoline Cross-linked Telopeptide Domain of Type I Collagen [ICTP])|CTX-I and ICTP are biochemical markers of bone resorption or bone degradation|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
146255|NCT00420199|Secondary|Double-blind Period: Median Percent Change From Baseline in Systemic Markers of Bone Formation: Osteocalcin and Serum Intact N-terminal Propeptide of Type I Procollagen (PINP)|PINP and osteocalcin are markers of bone formation. Osteocalcin is synthesized by osteoblasts and is associated with osteoblast synthetic activity. Osteoblasts secrete type 1 procollagen, and cleavage of large fragments from the carboxy and amino terminal ends result in formation of mature type 1 collagen and production of PINP fragments.|Baseline to Days 15, 29, 57, 85, and 113|All randomized participants who received at least 1 dose of study medication.||percent change||Inter-Quartile Range|Median
146708|NCT00413959|Primary|Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.|Percentage of complete responders plus percentage of partial responders equals overall response rate.|4 years|1 pt withdrew before completing two cycles and was not evaluable for OS.||percentage of patients|||Number
146256|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in RAMRIS Scores|RAMRIS Score=sum of core components: Synovitis (S), Osteitis (O), and Erosion (E) Scores. S scored 0 (none) to 9 (maximum distension of synovial cavity); O scored 0 (none) to 69 (maximum articular bone involvement); E scored 0 (none) to 230 (maximum erosion of articular bone). RAMRIS=S+O+E Scores. RAMRIS minimum score=0 (normal), maximum=308 (severe structural damage). Adjusted change from baseline in RAMRIS=mean RAMRIS at Day 113-mean RAMRIS at baseline. Adjustment based on ANCOVA model: treatment=factor, baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
146257|NCT00420199|Secondary|Double-blind Period: Baseline Mean RAMRIS Scores|RAMRIS score is the sum of its core components: Synovitis Score, Osteitis Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Osteitis scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Osteitis Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Osteitis Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Baseline|All randomized participants who received at least 1 dose of study medication and had RAMRIS assessments available at baseline.||units on a scale||Standard Deviation|Mean
146258|NCT00420199|Secondary|Double-blind Period: Number of Participants With Newly Involved Joints in Bone Erosion, Edema/Osteitis, and Synovitis|Bone erosion and osteitis were assessed at a total of 23 anatomic locations according to erosion (for bone erosion) or involvement (for osteitis) of the original articular bone. Synovitis assessed as above-normal post-gadolinium enhancement in 3 wrist regions: distal radioulnar joint, radiocarpal joint, and intercarpal and carpometacarpal joints.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion, edema, and synovitis assessments available at baseline and Day 113.||participants|||Number
146259|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Osteitis OMERACT 6 Scores|Osteitis assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached. Each site scored in 1.0 increments, indicating involvement of original articular bone (0=none to 3=severe). Total score for hands/wrists is sum of scores for each location. Maximum score per hand/wrist is 23 (total anatomic locations)*3 (maximum score per joint)=69. Minimum score=0(normal). Increasing score=greater severity. Adjusted mean change from baseline in osteitis score=mean score at Day 113-mean score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
146260|NCT00420199|Secondary|Double-blind Period: Baseline Mean Osteitis OMERACT 6 Scores|Osteitis assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had osteitis OMERACT 6 assessments available at baseline.||units on a scale||Standard Deviation|Mean
146261|NCT00420199|Primary|Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis=Follow-up synovitis score-baseline score.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had wrist synovitis assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
146262|NCT00420199|Secondary|Double-blind Period: Adjusted Mean Change From Baseline in Erosion OMERACT 6 Scores|Bone erosion assessed at 23 anatomic locations: 15 in 1 wrist and 8 in attached hand. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. Total erosion score for hands/wrists is sum of the individual scores for each location. Thus the maximum score per hand/wrist is 230. Increasing score=greater severity. Adjusted change from baseline in erosion score=mean score at Day 113-mean erosion score at baseline. Adjustment based on ANCOVA model with treatment=factor and baseline value=covariate.|Baseline to Day 113|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline and Day 113.||units on a scale||Standard Deviation|Mean
146263|NCT00420199|Secondary|Double-blind Period: Baseline Mean Erosion OMERACT 6 Scores|Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.|At baseline|All randomized participants who received at least 1 dose of study medication and had erosion OMERACT 6 assessments available at baseline.||units on a scale||Standard Deviation|Mean
146264|NCT00420199|Primary|Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS)|Wrist synovitis was assessed by postgadolinium MRI enhancement according to OMERACT 6 RAMRIS in 3 wrist regions: distal radioulnar, radiocarpal, and intercarpal and carpometacarpal joints. For each wrist region, possible score ranges from 0–3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. Change in synovitis = Follow-up synovitis score - baseline score.|At baseline|All randomized participants who received at least 1 dose of study medication and had synovitis assessments available at baseline.||units on a scale||Standard Deviation|Mean
146265|NCT00420095|Secondary|Hypoglycemia Rate Per Participant Per 30 Days|Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.|over 12 weeks of each treatment period|Includes all randomized patients who had at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||events/30 days||95% Confidence Interval|Mean
146266|NCT00420095|Secondary|Number of Participants With Laboratory Parameters Significantly Different From Baseline|Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients receiving at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||participants|||Number
146267|NCT00420095|Secondary|Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%|Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.|12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||participants|||Number
146268|NCT00420095|Secondary|Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment|Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.||units of insulin||95% Confidence Interval|Mean
146269|NCT00420095|Secondary|Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment|Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.||millimoles/Liter||95% Confidence Interval|Mean
146270|NCT00420095|Secondary|Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment|Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.|Baseline and at 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
146271|NCT00420095|Primary|Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint|Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.|Baseline and 12 weeks of each treatment|Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.||percent of glycosylated hemoglobin||95% Confidence Interval|Mean
146272|NCT00420056|Secondary|Correlation Coefficient Between Plasma PD 0332991 Concentration and Change From Baseline in Biomarkers and SUVmax at Cycle 1 Day 21|Plasma PD 0332991 concentration at Cycle 1 Day 21 was analyzed. Change from baseline in biomarkers (Ki-67 composite score, Cyclin D1 composite score, phospho-Rb positive cells) and SUVmax (FLT-PET SUVmax, FDG-PET SUVmax) at Cycle 1 Day 21 were analyzed. Correlation between PD 0332991 concentration and change in biomarkers (concentration versus Ki-67, concentration versus Cyclin, and concentration versus phospho-Rb) and SUVmax (concentration versus FLT-PET SUVmax, concentration versus FDG-PET SUVmax) was then assessed. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|PD 0332991 concentration was analyzed using pharmacokinetic analysis set (participants in FAS who had also completed pharmacokinetic blood sampling for at least 1 day); SUVmax and biomarkers were analyzed using imaging analysis set and tumor analysis set respectively. n= participants evaluable for this measure for specified comparisons.||correlation coefficient|||Number
146273|NCT00420056|Secondary|Time to Tumor Progression (TTP)|Time in months from date of first dose of study medication to first documentation of objective tumor progression (PD). TTP= (last known progression-free date minus date of first dose of study medication plus 1) divided by 30.44. PD was defined as greater than 50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.||months||95% Confidence Interval|Median
146281|NCT00420056|Primary|Cyclin D1 Composite Score at Baseline|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
146274|NCT00420056|Secondary|Duration of Response (DR)|Time in months from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to objective tumor progression (PD) or death due to any cause. DR= (date of first documentation of PD or death, minus the date of first CR or PR plus 1) divided by 30.44. CR= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before start of therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration. PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease. PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|For duration of response, the number of participants experiencing objective response was less than 50%, and therefore, it was not feasible to calculate duration of response using Kaplan-Meier method. Hence, no participant was analyzed for this outcome measure.|||||
146275|NCT00420056|Secondary|Percentage of Participants With Objective Response|OR is defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR). Confirmed responses are those that persist on repeat imaging study 4 weeks after initial documentation of response. Complete response (CR)= disappearance of all detectable clinical/radiographic evidence of disease, disease related symptoms present before therapy and biochemical abnormalities attributable to disease, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeated bone marrow aspiration; Partial response (PR)= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions in organs (spleen/liver) regressed by >50% in SPD, no new sites of disease.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.||percentage of participants||95% Confidence Interval|Number
146276|NCT00420056|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease. PFS= (first event date minus the first dose date plus 1) divided by 30.44.|Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks)|Response analysis set included all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed.||months||95% Confidence Interval|Median
146277|NCT00420056|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The events which were considered treatment-related by sponsor and/or investigator were reported.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
146278|NCT00420056|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity|AE = any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. Severity was assessed as: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe) = unacceptable or intolerable events, significantly interrupting usual daily activity, and requiring systemic medication therapy/other treatment; Grade 4 (Life-threatening) = events causing participant to be in imminent danger of death; Grade 5 (Death) = death related to an AE. Treatment-emergent events = between first dose of study medication and up to 28 days after last dose, that were absent before treatment or that worsened relative to pre-treatment state. A participant may be represented in more than 1 category.|Day 1 up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
146279|NCT00420056|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory test abnormality: Hematology (Hemoglobin [<0.8*lower limit of normal {LLN}], Platelets [<0.5*LLN/ >1.75*upper limit of normal {ULN}], White blood cells [<0.6*LLN/ >1.5*ULN], Lymphocytes, Neutrophils [<0.8*LLN/ >1.2*ULN], Basophils, Eosinophils, Monocytes [>1.2*ULN]); Liver Function (Total bilirubin [>1.5*ULN], Aspartate aminotransferase, Alanine aminotransferase, Lactate dehydrogenase, Alkaline phosphatase [>0.3*ULN], Total protein, Albumin [<0.8*LLN/ >1.2*ULN]); Renal Function (Blood urea nitrogen, Creatinine [>1.3*ULN], Uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/ >1.05*ULN], potassium, chloride, calcium, magnesium [<0.9*LLN/ >1.1*ULN], phosphate [<0.8*LLN/ >1.2*ULN]); Other (Glucose [<0.6*LLN/ >1.5*ULN]).|Baseline up to 28 days after last dose of study medication|Safety analysis set included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
146280|NCT00420056|Primary|Cyclin D1 Composite Score at Cycle 1 Day 21|Percentage of Cyclin D1 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
146304|NCT00419952|Secondary|Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment|Total ectopic supraventricular (VE) beats – number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients||Participants|||Number
146282|NCT00420056|Primary|Ki-67 Composite Score at Cycle 1 Day 21|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
146283|NCT00420056|Primary|Ki-67 Composite Score at Baseline|Percentage of Ki-67 positive cells was determined by Immunohistochemical staining technique. Composite score = (sum of each intensity category multiplied by percent of cells in that category). Intensity categories of staining (0 = no staining; 1 = weak staining; 2 = moderate staining; 3 = strong staining). Composite score ranges from 0 (no staining) to 300 (100% of cells with 3 staining intensity).|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||units on a scale||Standard Deviation|Mean
146284|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Cycle 1 Day 21|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||percentage of tumor cells||Standard Deviation|Mean
146285|NCT00420056|Primary|Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Baseline|Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique.|Baseline|Tumor analysis set include all participants in FAS who completed tumor biomarker assessments at baseline and Day 21. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.||percentage of tumor cells||Standard Deviation|Mean
146286|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Objective Response (OR)|OR: CR= disappearance of all clinical/radiographic evidence of disease, disease related symptoms and biochemical abnormalities, nodal masses regressed to normal size, if spleen and bone marrow were involved, spleen regressed to normal size and not palpable and clear infiltrate on repeat bone marrow aspiration; PR= dominant nodes decreased by >50% in sum of products of diameters (SPD), no increase in size of other nodes/liver/spleen, lesions regressed by >50% in SPD, no new sites of disease; SD= response <PR and no PD, documented >=1 time after start of therapy, no new sites of disease; PD= >50% increase in SPD of dominant nodes and other nodes or appearance of new sites of disease. PET response: CR= mean SUVmax same as background; PR= mean SUVmax <75% of baseline; PD= mean SUVmax >125% of baseline; SD= mean SUVmax >=75% of baseline but <=125% of baseline. Correlation was reported as conjoint number of participants with PET response at Cycle 1 Day 21 and OR at end of study.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for OR|PET response was analyzed using Imaging analysis set and OR was analyzed using response analysis set (all participants enrolled in the study who received at least 1 dose of study medication in cycle 1 and for whom a post-treatment response assessment was completed).||participants|||Number
146287|NCT00420056|Primary|Correlation Between Positron Emission Tomography (PET) Response and Progression-Free Survival (PFS)|PET response was defined as complete response (CR) = mean SUVmax same as of background; partial response (PR) = mean SUVmax less than (<) 75 percent (%) of baseline; progressive disease (PD) = mean SUVmax greater than (>) 125% of baseline; stable disease (SD) = mean SUVmax greater than or equal to (>=) 75% of baseline and mean SUVmax less than or equal to (<=) 125% of baseline. PFS was defined as the time from first dose of study medication to the first documentation of objective tumor progression, or to death due to any cause, whichever occurred first. Tumor progression was defined as >50% increase in sum of products of diameters, of dominant nodes and documented non-nodal sites or appearance of new sites of disease.|Baseline, Cycle 1 Day 21 for PET response; Screening until tumor progression or death, assessed on Day 1 of every alternate cycle starting from Cycle 1 up to end of treatment (Day 609) or early withdrawal (if not completed during last 6 weeks) for PFS|Analysis for this outcome measure was not run as there were so few responders.|||||
146288|NCT00420056|Primary|Change From Baseline in Maximum Standard Uptake Value (SUVmax) at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Change from baseline in SUVmax was assessed using [(18)F]-FLT-PET and [(18)F]-FDG-PET techniques.|Baseline, Cycle 1 Day 21|Imaging analysis set included participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment (Day 21) PET.||standard uptake value (SUV)||Standard Deviation|Mean
146289|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FDG-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-FDG-PET and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).||correlation coefficient|||Number
146709|NCT00413920|Secondary|Number of Participants Requiring Steroids in Non-steroid Treatment Group||Months 3 and 6|||Number of participants|||Number
146290|NCT00420056|Primary|Correlation Coefficient Between Change From Baseline in Fluoro-L-thymidine Positron Emission Tomography (FLT-PET) Maximum Standard Uptake Value (SUVmax) and in Phosphorylated Retinoblastoma (Phospho-Rb) Percent Positive Cells at Cycle 1 Day 21|Maximum standard uptake value (SUVmax) was defined as the maximum value attained for the ratio of tissue radioactivity concentration at any time and the injected radioactivity concentration divided by the body weight (in kilogram [kg]). Phosphorylation of retinoblastoma (Rb) protein in the tumor cells, expressed as phospho-Rb percent positive cells, was assessed using Immunohistochemical staining technique. Change from baseline in [(18)F]-FLT-PET SUVmax at Cycle 1 Day 21 and change from baseline in Phospho-Rb percent positive cells at Cycle 1 Day 21 were analyzed. The change values of FLT-PET SUVmax and Phospho-Rb percent positive cells were then correlated. Here, ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Cycle 1 Day 21|SUVmax was analyzed using imaging analysis set (participants in FAS who completed baseline [(18)F]-fluorodeoxyglucose PET [FDG-PET] and [(18)F]-FLT-PET, and at least 1 on-treatment [Day 21] PET) and phospho-Rb was analyzed using tumor analysis set (participants in FAS who completed tumor biomarker assessments at baseline and Day 21).||correlation coefficient|||Number
146291|NCT00420017|Secondary|Number of Participants With Adverse Effects|Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)|7 days|Per protocol||patients|||Number
146292|NCT00420017|Secondary|Length of Post-surgical Intensive Care Unit Stay||7 days|||hours||Inter-Quartile Range|Median
146293|NCT00420017|Secondary|Length of Post-surgical Hospital Stay||Duration of hospitalization|||days||Inter-Quartile Range|Median
146294|NCT00420017|Primary|Incidence of Atrial Fibrillation||7 days|Analysis was per protocol||participants|||Number
146295|NCT00419952|Secondary|Asthma Treatment Satisfaction Measure (ATSM)|Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||units on a scale||95% Confidence Interval|Least Squares Mean
146296|NCT00419952|Secondary|Forced Expiratory Volume in One Second (FEV1)|Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Litres||95% Confidence Interval|Least Squares Mean
146297|NCT00419952|Secondary|Peak Expiratory Flow (PEF) in Morning|Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Liters/minute||95% Confidence Interval|Least Squares Mean
146298|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|Number of participants with positive response to Item 5 in questionnaire “During the past week, you were satisfied with how quickly you felt your study medication begin to work.” The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of “strongly agree” or “somewhat agree”|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Participants|||Number
146299|NCT00419952|Secondary|Onset of Effect Questionnaire (OEQ)|Number of participants with positive response to Item 2 in questionnaire “During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of “strongly agree” or “somewhat agree”|1 week|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Participants|||Number
146300|NCT00419952|Secondary|Diary Assessments - Asthma-control Day|Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered “no” to having symptoms and “0” to the use of rescue medication that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||percentage of Asthma-control day||95% Confidence Interval|Least Squares Mean
146301|NCT00419952|Secondary|Diary Assessments - Symptom-free Day|Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered “no” to having symptoms that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||percentage of Symptom-free day||95% Confidence Interval|Least Squares Mean
146302|NCT00419952|Secondary|Diary Assessments - Rescue-free Day|Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered “no” to having used rescue medication that day|baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Percentage of Rescue Free Day||95% Confidence Interval|Least Squares Mean
146303|NCT00419952|Secondary|Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment|Total ventricular runs – number of participants with shift normal (<1) to high (≥1) from baseline to week 2.|Baseline and 2 weeks (visit 4)|Data were available for a subset of patients.||Participants|||Number
146771|NCT00413634|Secondary|Heart Rate|Heart rates in patients with ET receiving Agrylin|over 1 day|Safety population||beats/min||Standard Deviation|Mean
146306|NCT00419952|Secondary|QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)|QT interval corrected using the Fridericia formula [QTc (Frid)] – Change from baseline to end of treatment|Baseline and 52 weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||msec||95% Confidence Interval|Least Squares Mean
146307|NCT00419952|Secondary|Asthma Exacerbations|Number of participants with at least 1 exacerbation|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Participants|||Number
146308|NCT00419952|Primary|Total Number of Asthma Exacerbations|An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.|52 Weeks|The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.||Exacerbations|||Number
146309|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Per Protocol (PP) population.||number of participants|||Number
146310|NCT00419926|Secondary|Renal Function Assessed by Serum Creatinine at Each Visits||at 21 days, 84 days and 180 days||||||
146311|NCT00419926|Secondary|Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit|The Modification of Diet in Renal Disease (MDRD) formula was used to calculate the GFR. Serum creatinine levels, age, sex and race were used to estimate the GFR levels in mL/min/1.73m^2.|at 21 days, 84 days and 180 days|Intention to treat (ITT) population.||(mL/min/1.73m^2)||Standard Deviation|Mean
146312|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Per Protocol (PP) population.||number of participants|||Number
146313|NCT00419926|Secondary|Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death|The overall treatment differences of the number of participants with at least one occurrence of the composite event BPAR, GFL or death at study days 21 and 84 post-transplantation. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|21 and 84 days|Intention to treat (ITT) population.||number of participants|||Number
146314|NCT00419926|Primary|Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death|To evaluate therapeutic benefit by comparing the efficacy defined as the number of participants with treatment failure (biopsy-proven acute rejection [BPAR], graft loss [GFL] or death) at 6 months post-transplant. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III using Banff 2000 classification. A graft core biopsy was performed within 24 hours of initiation of anti-rejection therapy. GFL was defined as the day the allograft was presumed lost (the day the patient started dialysis, the day of nephrectomy or the day of irreversible graft loss demonstrated by imaging techniques.)|6 months|Intention to treat (ITT) population.||number of participants|||Number
146315|NCT00419770|Primary|Total Adverse Events||30 Days After End of Therapy|||Events|||Number
146316|NCT00419770|Secondary|Survival, Radiographic Improvement, Clinical Response, Time to Survival, Deferasirox vs. Free Iron Level Correlation||Up to 90 days||||||
146317|NCT00419770|Secondary|Deferasirox Pharmacokinetic and Pharmacodynamic Parameters||7 days||||||
146318|NCT00419770|Primary|Global Response Rate (Composite of Clinical and Radiographic Response) at End of Study Drug Administration, as Determined by a Blinded Adjudication Committee||14 days||||||
146319|NCT00419770|Primary|Safety and Tolerability of Adjunctive Deferasirox Therapy in Patients Being Treated With LAmB for Mucormycosis||14 days||||||
146320|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications|Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
146321|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication|Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
146443|NCT00418015|Primary|Duration of Intrathecal Analgesia Following Cesarean Delivery|Time until request for supplemental analgesia following intrathecal morphine/fentanyl for cesarean delivery|0 to 72 hours following cesarean delivery|Subjects that received fentanyl and morphine for postpartum analgesia after planned cesarean delivery were analyzed per protocol.||Hours||Inter-Quartile Range|Median
146322|NCT00419757|Secondary|Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index|Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.|Week 12|Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
146323|NCT00419757|Secondary|Physician Global Assessment|"The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as “Yes” and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Perscentage of Participants|||Number
146324|NCT00419757|Secondary|Subject Global Assessment|"The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as “Yes” and points 3, 4, 5 as No. Percent of Participants that gave positive responses."|Baseline and week 12|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percent of Participants|||Number
146325|NCT00419757|Secondary|Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of days||Standard Error|Least Squares Mean
146326|NCT00419757|Secondary|Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment|Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of days||Standard Error|Least Squares Mean
146327|NCT00419757|Secondary|Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment|Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||puffs/day||Standard Error|Least Squares Mean
146328|NCT00419757|Secondary|Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks|Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of nights||Standard Error|Least Squares Mean
146329|NCT00419757|Secondary|Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.~Daily scale:~0 = No symptoms~1 = Mild symptoms~2 = Moderate symptoms~3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
146330|NCT00419757|Secondary|Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks|"Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.~Daily scale:~0 = No symptoms~1 = Mild symptoms~2 = Moderate symptoms~3 = Severe symptoms"|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Units on a scale||Standard Error|Least Squares Mean
146331|NCT00419757|Secondary|Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Liters/minutes||Standard Error|Least Squares Mean
146332|NCT00419757|Secondary|Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.|Baseline, 2, 6 and 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Liters||Standard Error|Least Squares Mean
146333|NCT00419757|Secondary|"Percentage of Participants With Withdrawals Due to Pre-defined Asthma Events"|"Percentage of participants with Withdrawals Due to Pre-defined Asthma Events as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated."|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of Participants|||Number
146334|NCT00419757|Secondary|Percentage of Participants With Pre-defined Asthma Events|Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication|12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Percentage of Participants|||Number
146335|NCT00419757|Primary|Morning Peak Expiratory Flow (AM PEF)|Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.|Baseline (run-in) and throughout 12 weeks|Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.||Liters/minutes||Standard Error|Least Squares Mean
146336|NCT00419744|Primary|Rate of Exacerbations Per Subject-year|Rate of exacerbations per subject-year|12 months|||Rate|||Number
146337|NCT00419744|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.|12 months|||Scores on a scale||Standard Deviation|Mean
146338|NCT00419744|Secondary|Use of Rescue Medication|Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.|12 months|||Number of inhalations||Standard Deviation|Mean
146339|NCT00419744|Secondary|Dyspnea Symptom Scores|Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.|12 months|||Scores on a scale||Standard Deviation|Mean
146340|NCT00419744|Secondary|Evening PEF|Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.|12 months|||L/min||Standard Deviation|Mean
146341|NCT00419744|Secondary|Morning Peak Expiratory Flow (PEF)|Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.|12 months|||L/min||Standard Deviation|Mean
146342|NCT00419744|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.|12 months|||Liters (L)||Standard Deviation|Mean
146343|NCT00419744|Primary|Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year|Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.|12 months|||Exacerbations|||Number
146344|NCT00418379|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.~Participants assessed daily, during the Year 3 pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 33.8 days) of Year 3|Full Analysis Set Year 3 (FASY3). FASY3 included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score (AdSS) during the pollen period while on treatment during the Year 3.||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
146345|NCT00419445|Primary|To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid).|The proportion of subjects with Treatment Emergent Adverse Events.|Baseline to study completion|||% of subjects|||Number
146346|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months.|Study entry through 12 months|Of the 190 subjects beginning the study, 49 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 12 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.||percentage of subjects|||Number
146347|NCT00419393|Secondary|Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months|Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months.|Study entry through 6 months|Of the 190 subjects beginning the study, 139 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 6 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure.||percentage of subjects|||Number
146348|NCT00419393|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.||number of subjects|||Number
146349|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.||number of subjects|||Number
146350|NCT00419393|Primary|Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.|Duration of the Treatment Period (6 months-2 years)|Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here.||number of subjects|||Number
146351|NCT00419380|Secondary|Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.|Outcome measure data table represents the absence of drainage at day- 14|14 days|||Ear|||Number
146352|NCT00419380|Primary|Patency of the Tympanostomy Tube at the Day-14 Visit.||14 days|Analysis performed on ear level. Some participants received drops in both ears and thus both ears were included in analysis.||Ear|||Number
146353|NCT00419341|Other Pre-specified|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.||local reactions per infusion|Participants||Number
146354|NCT00419341|Other Pre-specified|Rate of All AEs by Relatedness and Seriousness|The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 15 months|The ITT population included all subjects who were treated with IgPro20 during any study period.||AEs per infusion|Participants||Number
146355|NCT00419341|Other Pre-specified|Minimum Concentration (Cmin) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||g/L||Standard Deviation|Mean
146356|NCT00419341|Secondary|Tmax at Steady State|Timepoint of maximum concentration (Cmax)|Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||days||Full Range|Median
146357|NCT00419341|Secondary|Maximum Concentration (Cmax) of Total Serum IgG at Steady State||Week 28 ± 1 week of the treatment period|The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||g/L||Standard Deviation|Mean
146358|NCT00419341|Secondary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Every 4 weeks, throughout the 12-month efficacy period|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||g/L||Standard Deviation|Mean
146359|NCT00419341|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days per subject year|Participants||Number
146360|NCT00419341|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days|||Number
146361|NCT00419341|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days per subject year|Participants||Number
146362|NCT00419341|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||days|||Number
146363|NCT00419341|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.||days per subject year|Participants||Number
146364|NCT00419341|Secondary|Number of Infection Episodes (Serious and Non-serious)|Total number of infections for the specified analysis population|Efficacy period: up to 12 months (week 13 to the completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study.||infections|||Number
146365|NCT00419341|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Efficacy period: up to 12 months (week 13 to completion visit)|The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.||infection episodes per subject year|Participants|95% Confidence Interval|Number
146366|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (PPE Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The Per Protocol Efficacy (PPE) population included all subjects who completed the 12-month efficacy period according to the protocol-defined requirements.||SBIs per subject year|Participants||Number
146367|NCT00419341|Secondary|Annualized Rate of Clinically Documented SBIs (ITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the study for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|For the duration of the study, up to 15 months|The Intention To Treat (ITT) population included all subjects who were treated with IgPro20 during any study period.||SBIs per subject year|Participants||Number
146368|NCT00419341|Primary|Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG)|Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03_002CR [NCT00168025] or ZLB05_006CR [NCT00322556]).|Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment|The Per Protocol Pharmacokinetic (PPK) population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study.||days*g/L||Standard Deviation|Mean
146369|NCT00419341|Primary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population)|"The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs."|Efficacy period: up to 12 months (week 13 to the completion visit)|The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study.||SBIs per subject year|Participants||Number
146370|NCT00419315|Secondary|Percent Days of Heavy Alcohol Use|This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).|6 months|||percentage of heavy drinking days||Standard Deviation|Mean
146371|NCT00419315|Primary|Treatment Engagement|This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.|6 months|||percentage of participants engaged|||Number
146372|NCT00419263|Secondary|Change From Baseline to Day 9 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 192 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
146373|NCT00419263|Secondary|Change From Baseline to Day 5 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 96 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
146385|NCT00419120|Secondary|Overall Safety Profile - Number of Participants Experiencing an Adverse Event|clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information.|periodically within first 12 months as well as during long term follow up out to 5 years|||participants|||Number
146374|NCT00419263|Secondary|Change From Baseline to Day 3 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 48 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
146375|NCT00419263|Secondary|Change From Baseline to Day 2 in Influenza Virus Titer|The change in viral titers was defined as the time-weighted change from baseline in log_10 tissue culture infective dose_50 (TCID_50/mL) and was summarized for each treatment group. The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior. Specimens for virologic culture and determination of influenza virus TCID_50/mL were obtained on Day 2 (approximately 24 hours after treatment), on Day 3 (approximately 48 hours after treatment), on Day 5 (approximately 96 hours after treatment), and on Day 9 (approximately 192 hours after treatment).|Baseline and approximately 24 hours after treatment|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||log10(TCID50/mL)||Full Range|Median
146376|NCT00419263|Secondary|Time to Resumption of Ability to Perform Usual Activities|The time to resumption of a subject’s self-assessed ability to perform his or her usual activities was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who were not able to resume performance of usual activities were censored at the time of the last assessment.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||Days||95% Confidence Interval|Median
146377|NCT00419263|Secondary|Time to Resolution of Fever|The time to resolution of fever (defined as the number of hours from initiation of study drug until temperature is less than 37.2 degrees C [99.0 degrees F] and no antipyretic medications had been taken in the previous 12 hours) was estimated using the method of Kaplan-Meier. Differences between the treatment groups were assessed using the log rank statistic controlling for current smoking behavior. Subjects who did not have resolution of fever were censored at the time of the last assessment. No adjustment for multiple comparisons was performed.|Up to 14 days|The ITTI population included all subjects who were randomized, received study drug, and had proven influenza by any one of the following: culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Subjects were analyzed according to the treatment to which they were randomized.||Hours||95% Confidence Interval|Median
146378|NCT00419263|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with placebo was performed.|Up to 14 days|The intent-to-treat infected (ITTI) population included all randomized subjects who received study drug and had proven influenza by culture, PCR, or paired serology showing ≥ 4-fold increase in antibody to influenza A or B. Of the 318 subjects in the ITTI population, one subject had insufficient data to determine Time to Alleviation of Symptoms.||Hours||95% Confidence Interval|Median
146379|NCT00419159|Primary|The Number of Participants With Best Overall Response: Complete Response (CR, No Lesions), Partial Response (PR, 30% Decrease in Lesions), and Stable Disease (SD, None of the Above) According to Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments."|Imaging every 8 weeks|Full Analysis Set||Participants|||Number
146380|NCT00419159|Secondary|Biomarkers Predictive of Clinical Benefit on Everolimus (RAD001)||Screening and Day 1 of cycles 2, 3, 4 and end of treatment||||||
146381|NCT00419159|Secondary|Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAEv3.0). On treatment death defined as deaths occurring no more than 28 days after the discontinuation of study treatment.|From the first day of treatment until 28 days after discontinuation of study treatment|Safety set analysis||Participants|||Number
146382|NCT00419159|Secondary|Overall Survival (OS)|Overall survival defined as the time from date of first study treatment to the date of death due to any cause.|Every 3 months|Overall Survival [OS] was analyzed in Full Analysis Set [FAS].||Months||95% Confidence Interval|Median
146383|NCT00419159|Secondary|Progression-free Survival (PFS)|Duration in months from the date of first study treatment to the date of the first documented disease progression or death due to any cause.|Imaging every 8 weeks|Progression- Free Survival (PFS) was analyzed in Full Analysis Set [FAS].||Months||95% Confidence Interval|Median
146384|NCT00419159|Primary|Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|"RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments.~Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response)."|Imaging every 8 weeks|Per Protocol Set||Percentage of participants||95% Confidence Interval|Number
146386|NCT00419120|Primary|Number of Responders as Assessed by Compliance|Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders|12 months|The analysis population of the primary outcome measure is the all implanted population (Intent to Treat - ITT). There was no imputation of analysis measures.||participants|||Number
146387|NCT00419094|Secondary|The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Keppra XR 1000 mg arm was not intended for inferential analysis (planned 3 to 1 randomization, Keppra XR 2000 mg: 1000 mg). The Exit Rate was based on the duration between the start date of previous AED tapering to the earliest date an exit crterion was met. Subjects who prematurely discontinued for reasons unrelated to exit criteria were censored as of the last dose of study medication. Subjects who completed the study without meeting an exit criterion were censored as of Day 112.|112 days|Of the 57 (Keppra 1000 mg) subjects randomized, 54 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population.||proportion of subjects||95% Confidence Interval|Number
146388|NCT00419094|Secondary|The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.||proportion of subjects||95% Confidence Interval|Number
146389|NCT00419094|Secondary|The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase|The cumulative exit event rate at Day 112 was calculated using Kaplan Meier methods. The exit event rate estimate was based on the duration between the start date of previous AED tapering to the earliest date an exit event occured. Subjects who prematurely discontinued for reasons unrelated to exit criteria, adverse event, or lack of efficacy were censored as of the last dose of study medication. Subjects who completed the study without having an exit event were censored as of Day 112.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Evaluated for Keppra XR 2000 mg/day only.||proportion of subjects||95% Confidence Interval|Number
146390|NCT00419094|Primary|The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase|Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.|112 days|Of the 171 (Keppra 2000 mg) subjects randomized, 158 subjects entered the Previous Antiepileptic Drug Tapering Phase and were included in the Efficacy Population. Primary Efficacy analysis was conducted for the Keppra XR 2000 mg/day group only.||proportion of subjects||95% Confidence Interval|Number
146391|NCT00419003|Secondary|Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects|Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups|24, 48, or 72-hrs||||||
146392|NCT00419003|Primary|Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression. The primary outcome for the initial phase of the trial was the 24-h MADRS score, which included all 10 MADRS items.|24 Hours|||scores on a scale||95% Confidence Interval|Mean
146393|NCT00418977|Primary|Body Mass Index (BMI) Z-score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator|up to 1 year|||z-score||Standard Deviation|Mean
146394|NCT00418977|Secondary|BMI Percentile|Body Mass Index (BMI) percentile. This is not a primary outcome variable.|up to 1 year|||percentile||Standard Deviation|Mean
146395|NCT00418977|Secondary|BMI|body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year|||kg/m^2||Standard Deviation|Mean
146396|NCT00418977|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year|||pounds||Standard Deviation|Mean
146397|NCT00418977|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z-score.|up to 1 year|||inches||Standard Deviation|Mean
146398|NCT00418964|Secondary|Percentage Distal Femoral Bone Mineral Density (BMD)Decrease|% BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery|1 year||||||
146399|NCT00418964|Primary|International Knee Documentation Committee (IKDC)Knee Form 2000 Score|It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function.|1 year|||Score on a scale||Standard Deviation|Mean
146400|NCT00418951|Primary|Number of Participants With Invasive Fungal Infection|Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.|35 days from the start of therapy for induction participants and 42 days for salvage participants.|Outcome evaluability required at least two doses of study drug.||participants|||Number
146401|NCT00418938|Secondary|Duration of Response|Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||months||95% Confidence Interval|Median
146402|NCT00418938|Secondary|Disease Control|Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||% of participants||95% Confidence Interval|Number
146403|NCT00418938|Secondary|Time to Progression|Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.||months||95% Confidence Interval|Median
146404|NCT00418938|Secondary|Time to Response|Time to response is defined as time from the date of randomization to the date of first confirmed objective response|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||months||Inter-Quartile Range|Median
146405|NCT00418938|Secondary|Objective Response Rate|Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy, who had at least one baseline uni-dimensionally measurable target lesion based on central (and investigator, respectively) assessment using a modified RECIST criteria version 1.0, and who had evaluable KRAS status.||% of patients||95% Confidence Interval|Number
146406|NCT00418938|Secondary|Overall Survival|Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date.|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.||months||95% Confidence Interval|Median
146407|NCT00418938|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).|From randomization up to 65 months.|Analysis population include all enrolled subjects who received at least one dose of study therapy and do not include subjects with unevaluable KRAS status.||months||95% Confidence Interval|Median
146408|NCT00418886|Secondary|Longitudinal Analysis of Average Symptom Burden Index (ASBI) Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. ASBI is an average of the six symptom visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)."|ASBI is a score taken from the Lung Cancer Symptom Scale (LCSS) questionnaires administered every 3 weeks after randomisation|||mms on a visual analogue scale||Standard Error|Least Squares Mean
146409|NCT00418886|Secondary|Longitudinal Analysis of Lung Cancer Symptom Scale (LCSS) Total Score|"The longitudinal data analysis will include all non-missing visit scores and the model will include only the first 12 weeks of data. LCSS total score is an average of all nine visual analogue patient scales from none (0 mm) to as much as it could be (100 mm)"|LCSS questionnaires are to be administered every 3 weeks after randomisation|||mms on a visual analogue scale||Standard Error|Least Squares Mean
146410|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Average Symptom Burden Index (ASBI) Score|Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days. The ASBI is derived from 6 of LCSS’s 9 items|ASBI is a score taken from the LCSS questionnaires which are to be administered every 3 weeks after randomisation|||weeks||95% Confidence Interval|Median
146411|NCT00418886|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Lung Cancer Symptom Scale (LCSS) Total Score|TDS is the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A deterioration in symptoms is defined as a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days. The LCSS scale measures changes in symptoms associated with lung cancer.|LCSS questionnaires are to be administered every 3 weeks after randomisation|||weeks||95% Confidence Interval|Median
146412|NCT00418886|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||weeks||95% Confidence Interval|Median
146413|NCT00418886|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||Percentage of Participants|||Number
146439|NCT00418093|Primary|Partial Response Rate|Precentage of women who responded to the treatment regimen Response was determined by RECIST criteria|Outcome was assessed every 2 cycles (every 8 weeks) for the duration on study, an average of 4.5 cycles (18 weeks)|||percentage of patients on study|||Number
146414|NCT00418886|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 6 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||Percentage of Participants|||Number
146415|NCT00418886|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||months||95% Confidence Interval|Median
146416|NCT00418886|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||weeks||95% Confidence Interval|Median
146417|NCT00418886|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 6 weeks (+/- 3 days) from randomisation until objective progression|||weeks||95% Confidence Interval|Median
146418|NCT00418314|Secondary|All Cause, Cardiovascular and Heart Failure Hospitalization||12 months|||participants|||Number
146419|NCT00418314|Secondary|All-cause, Cardiovascular and Heart Failure Mortality;||12 months|Per protocol||participants|||Number
146420|NCT00418314|Primary|Heart Failure Clinical Composite Score|The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.|12 months|||participants|||Number
146421|NCT00418184|Secondary|Lipid Profile (Cholesterol, HDL, Triglycerides)||on weeks 0,15||||||
146422|NCT00418184|Secondary|Biochemical Parameters in Blood - Liver Functions (SGPT, SGOT, Total Bilirubin), Kidney Functions (BUN, Creatinine), Na, K, Cl, Ca||on weeks 0,15||||||
146423|NCT00418184|Secondary|Complete Blood Counts||on weeks 0,15||||||
146424|NCT00418184|Secondary|Barkley Side Effects Rating Scale (SERS)||on weeks 0,15||||||
146425|NCT00418184|Secondary|Essential Fatty Acid (EFA)-Deficiency Symptoms||on weeks 0,15||||||
146426|NCT00418184|Secondary|Vital Signs||on weeks 0,15||||||
146427|NCT00418184|Secondary|Blood Monoamines Metabolism||on week 0, 15||||||
146428|NCT00418184|Secondary|Plasma and Red Blood Cells Fatty Acid Profile||on weeks 0,15||||||
146429|NCT00418184|Secondary|Child Health Questionnaire (CHQ)- Parent-completed Form 50||on weeks 0,15||||||
146430|NCT00418184|Secondary|Test of Variables of Attention (TOVA)||on weeks 0,15||||||
146431|NCT00418184|Secondary|Clinical Global Impression of Improvement||on weeks 0,15||||||
146432|NCT00418184|Secondary|Strength and Difficulties Questionnaires - Home Version||on weeks 0,15||||||
146433|NCT00418184|Secondary|Strength and Difficulties Questionnaires - School Version||on weeks 0,15||||||
146434|NCT00418184|Secondary|Conners Rating Scale - Home Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on the childs home behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.||Scores on a scale||Standard Error|Mean
146435|NCT00418184|Primary|Conners Rating Scale - School Version|A questionnaire that assesses symptoms of ADHD in children and adolescents according to the DSM-IV guidelines. It consists of questions on classroom behavior. Based on the questionnaire results, subscales and global indexes are calculated, including restless-impulsive index, emotional lability index and hyperactive/impulsive subscale. The lowest scale score is 40 (best)and the highest is 90 (worse). Usually, a score below 62 is considered normal and a score above 62 is considered abnormal.|change from baseline in conners raiting scale at 15 weeks|The analysis includes per-protocol (PP) population. Out of the 162 children who completed the study, 15 children were excluded from PP analysis due to low compliance or protocol violation.||Scores on a scale||Standard Error|Mean
146436|NCT00418093|Secondary|Determine the Nature and Degree of Toxicities Following Treatment With Oxaliplatin, Gemcitabine, and Bevacizumab in This Patient Population.|The nature and toxicities of treatment were graded per the National Cancer Institute Common Terminology Criteria of Adverse Events version 3.0 Patients with grade 2 or higher toxicity were reported|Toxicities were assessed every cycle and for up to 30 days after being removed from the trial|All patients enrolled||percentage of participants|||Number
146437|NCT00418093|Secondary|Overall Survival|Duration of time participants are alive after enrolling on the study. Assessed by clinical records|Assessed every 3 months until death from disease, other causes, or loss to follow up at a median follow up of 24 months|All patients enrolled||weeks||95% Confidence Interval|Median
146438|NCT00418093|Secondary|Progression Free Survival|Time participant remains free of progression of her disease. Evaluated by RECIST criteria|Assessed every 2 cycles (every 8 weeks) of chemotherapy until progression of disease is documented with a median duration of follow up of 24 months|19||weeks||95% Confidence Interval|Median
146444|NCT00418015|Primary|Duration of Intrathecal Fentanyl Analgesia|Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery|Time (0-1440 minutes) to first analgesia request|Laboring parturients that received intrathecal fentanyl (25 micrograms) for initiation of labor analgesia were evaluated for this outcome per protocol.||Minutes||95% Confidence Interval|Median
146445|NCT00417989|Secondary|Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy|Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks|||participants||Standard Deviation|Mean
146446|NCT00417989|Secondary|Quality of Life - Short Form-36 (SF-36v2™), General Health|Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 Weeks|Adult population (18 and older) only||Participants||Standard Deviation|Mean
146447|NCT00417989|Secondary|Health Economic Outcomes (MRU)||Baseline and 52 weeks||07/2017||||
146448|NCT00417989|Secondary|Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score|Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.|Baseline and 52 weeks|Adult population (18 and older) only||participants||Standard Deviation|Mean
146449|NCT00417989|Secondary|Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks|||mmol/dl*min||Standard Deviation|Mean
146450|NCT00417989|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 52.|Baseline and 52 weeks|||mmol/dl*min||Standard Deviation|Mean
146451|NCT00417989|Secondary|Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.|Baseline and 52 weeks|||participants|||Number
146452|NCT00417989|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;|Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.|Baseline and 52 weeks|||number of events|||Number
146453|NCT00417989|Primary|Change in A1c From Baseline to 52 Weeks|Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 52 weeks|||Percent glycated hemoglobin||Standard Deviation|Mean
146454|NCT00417976|Secondary|Response Rates Defined by RECIST 1.0|The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients|6 months|||patients|||Number
146455|NCT00417976|Primary|Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy||6 months|||percent of patients|||Number
146456|NCT00417963|Secondary|Number of Participants Experiencing Restenosis|Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.|12 months after implantation|Number of participants experiencing restenosis through 12 months from implantation.||number of participants|||Number
146457|NCT00417963|Secondary|Number of Participants Experiencing Lesion Success|number of participants experiencing achievement of <50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.|at time of implantation|number of participants with lesion success defined as <50% residual stenosis.||number of participants|||Number
146458|NCT00417963|Secondary|Number of Participants Experiencing Device Success|Number of participants with successful delivery and deployment of device with <50% residual stenosis.|at time of implantation|Number of participants with successful delivery and deployment of device with <50% residual stenosis.||number of participants|||Number
146459|NCT00417963|Secondary|Number of Participants Experiencing Stroke Related Neurologic Deficit|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.|30 days from implantation|Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to index procedure.||number of participants|||Number
146460|NCT00417963|Secondary|Number of Patients Experiencing Access Site Complications|Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.|30 days following implantation|Number of participants experiencing access site complications requiring blood transfusion (>1 unit) or open repair.||Number of participants|||Number
146461|NCT00417963|Secondary|Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)|Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation|12 months from implantation|Number of participants experiencing target lesion revascularization up to 12 months from implantation||Number of participants|||Number
146462|NCT00417963|Primary|Percentage of Patients Experiencing Major Adverse Events (MAE)|A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.|365 days from implantation|All patients who were enrolled in the pivotal cohort were analyzed as an intention to treat population.||percentage of participants||95% Confidence Interval|Mean
146463|NCT00417885|Secondary|Clinical Benefit Rate (CBR)|The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.||rate|||Number
146464|NCT00417885|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks)|ITT. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
146465|NCT00417885|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7.|From start of study treatment until death|ITT. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
146466|NCT00417885|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer|Analyses on DR were to be performed for overall responders only. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
146467|NCT00417885|Secondary|Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)|OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 1 of every other cycle (8 weeks)|Analyses on OR were performed for subjects who received at least 1 dose of study medication.||participants|||Number
146468|NCT00417885|Primary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date – the date of enrollment +1)/7.|From start of treatment until Day 1 of every other cycle (8 weeks) or death|Intent-To-Treat (ITT) = all subjects who were enrolled in the trial. Data were not analyzed due to early termination.||weeks||Standard Deviation|Mean
146469|NCT00417612|Primary|Reduction of Parathyroid Hormone Area Under the Curve (PTHauc) of 20% or Greater|Clinically significant reduction of Mean PTHauc (% decrease >/= 20) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12|||percentage of participants|||Number
146470|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTH; Percentage Decrease)|Mean PTHauc (% decrease) for Paricalcitol (Active Drug) and Placebo from Baseline to Month 12.|Measured at baseline and Month 12|||participants|||Number
146471|NCT00417612|Secondary|Serum 1,25 (OH)2D||Measured at baseline and Month 12|||pg/ml||Standard Deviation|Mean
146472|NCT00417612|Secondary|Serum Intact Fibroblast Growth Factor 23 (FGF23)||Measured at baseline and Month 12|||pg/ml||95% Confidence Interval|Mean
146473|NCT00417612|Secondary|Percent Change in Urinary Calcium Excretion From Baseline to 1 Year|Percent change in daily urinary calcium excretion, which is calculated the measurements of the calcium in the subject's 24-hr urine collections done at baseline and at the 1 year timepoints|Measured at baseline and Month 12|||percent change||Standard Deviation|Mean
146474|NCT00417612|Secondary|Bone Scan Severity Score|"99-Tc-methylenediphosphonate bone scans were completed and analyzed using the following scale*: Bone scan severity scale with minimum score of 0 and maximum score of 4 (0 is no disease and 4 is greatest severity of disease).~Appearance of lumbar spine and the sacroiliac region were used as internal references to which all suspected lesions were compared, and scored as follows:~grade 0, normal scan without suspicious lesions grade 1, lesion(s) less intense than normal lumbar spine grade 2, lesion(s) similar in intensity to normal lumbar spine grade 3, lesions more intense than normal lumbar spine but similar to the normal sacroiliac region grade 4, lesions more intense than the normal sacroiliac region.~*devised by nuclear medicine radiologist at Yale New Haven Hospital"|Measured at baseline and Month 12|||units on a scale||Standard Deviation|Mean
146475|NCT00417612|Secondary|Serum Calcium||Measured at baseline and Month 12|||mg/dl||Standard Deviation|Mean
146476|NCT00417612|Secondary|Static Parameters of Serum Alkaline Phosphatase at Baseline and 1 Year for Paricalcitol and Placebo Arms.||Measured at baseline and Month 12|Alkaline phosphatase activity was analyzed separately for children (less than 18 years of age) and adults as values varied considerably between these two groups. In other outcome measure modules the paricalcitol group is comprised of 19 participants analyzed which includes adults and children. In this module, the children (2) are their own arm.||mg/dl||Standard Deviation|Mean
146477|NCT00417612|Primary|Area Under the Curve for Parathyroid Hormone (PTHauc) Measurement|Mean area under the curve for parathyroid hormone levels (PTHauc) sampled during a 26 hour study period, for Paricalcitol (Active Drug) and Placebo groups at Baseline and Month 12 .|Measured at baseline and Month 12|||nlEq*26hr/ml||Standard Deviation|Mean
146478|NCT00417482|Secondary|Weight|For each subject, the change in weight in pounds between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in weight over time.|Phase B, weeks 1-16 (study weeks 16-32)|Available data from all randomized subject (N=110) was used in this analysis. Weight measurements were unavailable at one or more time points for 3 subjects in the placebo group and for 6 subjects in the risperidone group.||pounds||Standard Deviation|Mean
146550|NCT00416455|Primary|Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen||Before surgery (DCT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients.||percentage of patients||95% Confidence Interval|Number
146479|NCT00417482|Secondary|Physical Self-Maintenance Scale (PSMS)|Physical Self-Maintenance Scale, which ranges from 1 to 30, with higher scores indicating WORSE functioning. For each subject, the change in PSMS between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in PSMS (worse functioning) over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis, with the exception of one placebo subject for whom PSMS data was not available at one time point||units on a scale||Standard Deviation|Mean
146480|NCT00417482|Secondary|AIMS|The Abnormal Involuntary Movement Scale (AIMS) assesses signs of tardive dyskinesia, a movement disorder that can occur with prolonged use of antipsychotic medication. The AIMS score ranges from 0 to 35, with higher scores indicating more severe symptoms. For each subject, the change in AIMS score between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in AIMS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110).||units on a scale||Standard Deviation|Mean
146481|NCT00417482|Secondary|Extrapyramidal Signs (EPS)|Extrapyramidal signs, also known as Parkinsonian signs, refer to signs of tremor, rigidity, and bradykinesia (slowed movement) that are seen in Parkinson's disease. Assessment of extrapyramidal signs (EPS) were made with the use of the Simpson-Angus scale (which ranges from 1-40) with higher scores indicating more extrapyramidal signs. For each subject, the change in EPS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in EPS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in the analysis (N=110).||units on a scale||Standard Deviation|Mean
146482|NCT00417482|Secondary|Treatment Emergent Symptoms Scale (TESS)|The Treatment Emergent Symptom Scale (TESS) assesses 26 somatic symptoms. Total scores range from 0-26, with a score of 0 or 1 for each item. Higher scores indicate more somatic symptoms. For each subject, the change in TESS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in TESS over time.|Phase B, weeks 1-16 (study weeks 16-32)|All randomized subjects were included in this analysis (N=110)||units on a scale||Standard Deviation|Mean
146483|NCT00417482|Secondary|Mini Mental State Exam (MMSE)|The MMSE assesses cognition. Scores range from 0-30, with higher scores indicating better cognition. For each subject, the change in MMSE between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in MMSE over time.|Phase B, weeks 1-16 (study weeks 16-32)|MMSE data were missing for 2 subjects in the placebo group and 1 subject in the risperidone group, so the number of subjects in this analysis were 38 (placebo) and 69 (risperidone), for a total of 107.||units on a scale||Standard Deviation|Mean
146484|NCT00417482|Secondary|Relapse by Study Week 48|Same definition and criteria as the primary outcome|16-32 weeks in Phase B (32-48 weeks in study)|Randomized subjects in each Arm who had not relapsed or terminated the study by the end of the first 16 weeks of Phase B were analyzed in the second 16 weeks of Phase B using intent to treat (ITT) principles.||participants|||Number
146485|NCT00417482|Primary|Relapse by Study Week 32|"A relapse occurred in Phase B (post-randomization) if both of the following criteria were met:~Increase in the Neuropsychiatric Inventory (NPI) core score of 30% or more OR a 5-point increase from the baseline NPI score at the end of Phase A~A score of 6 (much worse) or 7 (very much worse) on the Clinical Global Impression-Change (CGI-C) at any visit."|0-16 weeks in Phase B (16-32 weeks in study)|Analysis was performed as per intention to treat (ITT) principles.||participants|||Number
146486|NCT00417417|Other Pre-specified|Brachial Artery Flow-mediated Dilation|Brachial artery flow-mediated dilation in respone to 5 minutes of forearm ischemia|Two weeks following final administration of drug|Per protocol||percent change||Standard Deviation|Mean
146487|NCT00417417|Primary|C-Reactive Protein (CRP)|C-reactive protein levels in subjects randomized to rilonacept versus placebo injections.|2 wks following last drug administration|per protocol||mg/L||Standard Deviation|Mean
146488|NCT00417274|Primary|Efficacy of Quinacrine, Based on Prostate Specific Antigen (PSA) Response in Patients With Androgen-independent Metastatic Prostate Cancer|Patients who achieved a complete response (CR) or a partial response (PR) to therapy were allowed to continue to receive treatment until disease progression or unacceptable toxicity occurred, until the patient discontinued treatment for another reason, or for a total of 6 months. Patients who continued to show a CR or PR or who maintained stable disease (SD) after 6 months of therapy were to be allowed to continue therapy at the investigator’s discretion.|End of treatment|Based on clinical judgment||Participants|||Number
146489|NCT00417248|Secondary|Overall Survival||18 months|Data for this outcome measure was not collected or analyzed due to the early termination of the study.|||||
146490|NCT00417248|Primary|Time to Disease Progression (TTP)||18 months|The primary objective for this study was not analyzed due to termination of the study. No participants were on-study for a sufficient period of time to collect or analyze the time to disease progression data.|||||
146491|NCT00417170|Secondary|Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment|Arterial Compliance is determined by Pulse Wave Analysis measured by a detector placed at the carotid artery while taking ECG and tonometry at the same time. Procedure is repeated for the femoral artery. Pulse Wave data are calculated by dividing distance between 2 arteries by the difference between the rise delay of the distal pulse wave and the R wave of the QRS complex and the rise delay of the proximal pulse wave to the QRS complex. Data analysis used an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.||mmHg||Standard Error|Least Squares Mean
146500|NCT00417079|Secondary|Time to Tumor Progression|Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
146772|NCT00413634|Secondary|Platelet Count|Platelet counts in patients with ET receiving Agrylin|over 1 day|Safety population (defined as all patients who received study treatment)||x 1,000,000,000/L||Standard Deviation|Mean
146492|NCT00417170|Secondary|Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment|C-peptide level is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|Baseline and after 12 weeks of treatment|The PD analysis set included all subjects with available PD data and no major protocol deviations with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.||ng/mL||Standard Error|Least Squares Mean
146493|NCT00417170|Secondary|Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment|Insulin Concentration is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set included all participants with available PD data and no major protocol deviation with impact on PD data. During different time points, participants with observations at that time point were included in the analysis.||mU/L||Standard Error|Least Squares Mean
146494|NCT00417170|Secondary|Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment.|Insulin sensitivity is measured by the hyperglycemic euglycemic clamp procedure where a supine patient has 2 IV lines inserted for sampling blood. Regular human insulin (60mU/m^2 surface area/min) is infused for 120 minutes. Dextrose (20% w/v) is infused to maintain glycemia at < 100 mg/dL and is adjusted based on plasma glucose levels obtained every 5 minutes. Blood for glucose and insulin is taken at specified time intervals. Change from baseline data is analyzed by analysis of variance model including treatment and week as fixed factors, and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.||mg/kg/min||Standard Error|Least Squares Mean
146495|NCT00417170|Primary|Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment|MBF is measured by Positron Emission Tomography (PET) first at rest, then 45 minutes later, during cold pressor testing (CPT). The patient is placed in the PET scanner and injected with N-13 ammonia as a tracer. PET images are taken to assess myocardial blood flow at rest. After 40 minutes, the patient immerses one hand in ice water and PET images are taken to assess myocardial blood flow at sympathetic activation. Change from baseline data is analyzed by an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor.|At baseline and after 12 weeks of treatment|The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis.||mL/g/min||Standard Error|Least Squares Mean
146496|NCT00417079|Secondary|Pain Response|Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.|from baseline up to 104 weeks (study cut-off)|Pain Response (applies only to patients, in the Intention-To-Treat (ITT) population, with median PPI ≥2 on McGill-Melzack scale and/or mean Analgesic Score ≥10 points at baseline)||Percentage of participants||95% Confidence Interval|Number
146497|NCT00417079|Secondary|Time to Pain Progression|"Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score & noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy.~Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)"|from baseline up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. Data from 265 and 279 patients in the cabazitaxel and mitoxantrone groups, respectively, were censored as a results of > 2 PPI and/or AS assessments being missed during the same week (unless a complete evaluation of ≥5 values showed pain progression).||Months||95% Confidence Interval|Median
146498|NCT00417079|Secondary|PSA (Prostate-Specific Antigen) Response|PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.|from baseline up to 104 weeks (study cut-off)|Prostate Specific Antigen (PSA) response was evaluated only in patients, in the Intention-To-Treat population, with a baseline PSA >20ng/mL.||Percentage of participants||95% Confidence Interval|Number
146499|NCT00417079|Secondary|Time to Prostatic Specific Antigen (PSA) Progression|"In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later.~In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later."|at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
146547|NCT00416455|Secondary|Percentage of Patients With Locoregionally Advanced Cervical Cancer or High-risk Endometrial Cancer Who Have Biopsy-proven Disease Outside the Abdominal or Pelvic Lymph Nodes Detected by PET/CT Scanning||Up to 5 years||||||
146501|NCT00417079|Secondary|Overall Tumor Response|"Tumor Overall Response Rate (ORR) (only in patients with measurable disease):~Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria.~Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD.~Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response."|From the date of randomization up to 104 weeks (study cut-off)|Tumor response rate was evaluated only for patients, in the Intention-To-Treat (ITT) population, with measurable disease by Response Evaluation Criteria in Solid Tumor (RECIST).||percentage of participants||95% Confidence Interval|Number
146502|NCT00417079|Secondary|Time to Progression Free Survival (PFS)|Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
146503|NCT00417079|Primary|Overall Survival|"Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause.~In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first."|From the date of randomization up to 104 weeks (study cut-off)|Analysis was performed on the intention To Treat (ITT) population. The ITT population is composed of all randomized patients (i.e. patients assigned to a treatment group by the randomization, regardless of whether patients received any study drug or received a different study drug from which they were randomized).||Months||95% Confidence Interval|Median
146504|NCT00417027|Secondary|Overall Satisfaction Scores. Higher Scores Represent Greater Satisfaction With Analgesia During Labor and Delivery.|Patient satisfaction with analgesia management during labor and delivery. Scores are 0 to 100 with 0 complete dissatisfaction and 100 complete satisfaction with labor analgesia.|24 hours following labor analgesia|per protocal||Scores on a scale (0 toi 100)||Inter-Quartile Range|Median
146505|NCT00417027|Secondary|Highest Thoracic Dermatome Sensory Level to Ice. Higher Levels Are Given by Lower Thoracic Vertebral Number.|Highest level of sensory loss to ice 3 hours after initiation of epidural analgesia. Thoracic dermatomes specify the level at which the nerves exit the spinal column. Higher thoracic spread of analgesia suggests greater dispersion of the epidural solution and may correlate with better analgesia. Higher levels are given by lower thoracic vertebral number. For example dermatome 4 has greater spread than dermatome 5.|3 hours after initiation of labor analgesia|||participants|||Number
146506|NCT00417027|Secondary|Manual Bolus Doses Administered||Duration of labor analgesia|||participants|||Number
146507|NCT00417027|Secondary|Number of Patient Controlled Bolus Doses of Bupivacaine/Fentanyl Administered|Patient controlled bolus of analgesic solution could be requested by activating a button. Bolus were 5ml of the epidural solution (bupivacaine 6.25mg/ml and fentanyl 1.96mgml). Patient requested administrations were allowed every 10 minutes to a maximum of 30 ml of epidural solution per hour.|Duration of labor analgesia|per protocal||participants||Inter-Quartile Range|Mean
146508|NCT00417027|Secondary|Patient Controlled Bolus Attempts|The number of attempted self administered bolus doses of epidural analgesia solution for control of pain.|Duration of labor analgesia|per protocal||number of bolus attempts||Inter-Quartile Range|Mean
146509|NCT00417027|Secondary|Area Under the Visual Analog Pain Scores (0 to 100mm) Per Hour of Labor Analgesia Curve|The pain burden calculated as the area under the visual analog pain scale (0 to 100 mm) patient self reported assessment of pain. Pain assessment were made at regular intervals during labor and the area under the pain score per time curve was calculated as the pain burden during labor. Greater pain would be indicated by a larger area. Possible range would be 0 for no pain to 100 for severe pain.|Duration of labor analgesia|per protocal||0 to 100 mm per hour||Inter-Quartile Range|Median
146510|NCT00417027|Primary|Total Bupivicaine in Milligrams Administered Per Hour of Labor for Analgesia.|Total bupivacaine from epidural solution administered for labor analgesia normalized per hour of labor.|From initiation of labor analgesia until delivery less than 24 hours|per protocal||mg bupivacaine per hour||Inter-Quartile Range|Median
146511|NCT00416884|Primary|Number of Participants With Treatment-related Mortality|Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding|lifetime followup, up to 100 years.|||Participants|||Number
146512|NCT00416793|Secondary|Overall Response Rate|Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.|Evaluated at end of every second 3 week cycle for response||||||
146513|NCT00416793|Primary|Overall Survival Rate at 6 Months|Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.|up to 6 months|Analysis was per protocol; Limited analysis due to study early termination.||Proportion of participants|||Number
146514|NCT00416624|Secondary|Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
146548|NCT00416455|Secondary|Comparison of the Diagnostic Sensitivity and Specificity of Ferumoxtran-10 MRI vs MRI Alone, in Terms of Size Criteria in the Abdomen and Pelvis||Up to 5 years||||||
146515|NCT00416624|Secondary|Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
146516|NCT00416624|Secondary|Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
146517|NCT00416624|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale were calculated.|Weeks 4, 7, 10, 13 and 16|All patients that were evaluable per protocol with QOL data.||units on a scale||Standard Deviation|Mean
146518|NCT00416624|Secondary|The Percentage of Participants Reported Grade 3 or 4 Adverse Events|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|16 weeks|All patients that were evaluable per protocol and reported at least one value after baseline.||percentage of participants|||Number
146519|NCT00416624|Secondary|The Percentage of Participants With Dose Omitted Due to Hematologic Reason|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 Weeks|All patients that were evaluable per protocol.||percentage of Participants|||Number
146520|NCT00416624|Secondary|The Total RBC Transfusion Needed|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.||g/dL||Standard Deviation|Mean
146521|NCT00416624|Secondary|The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had RBC transfusions data.||percentage of participants|||Number
146522|NCT00416624|Secondary|Mean Hemoglobin Change From Week 1 to Week 16|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule. The positive numbers represent hemoglobin increases and negative numbers represent hemoglobin decreases.|Week 1 and Week 16|All patients that were evaluable per protocol and had hemoglobin data.||g/dL||Standard Deviation|Mean
146523|NCT00416624|Secondary|Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL|To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule|16 weeks|All patients that were evaluable per protocol and had hemoglobin levels data.||days||95% Confidence Interval|Median
146524|NCT00416624|Secondary|Weekly Change in Hemoglobin Levels|To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa schedule|Baseline and Week 4, 7, 10, 13, 16|All patients that were evaluable per protocol and had hemoglobin data at baseline, week 4, 7, 10, 13 or 16.||g/dL||Standard Deviation|Mean
146525|NCT00416624|Primary|The Percentage of Participants Who Exhibit a Hematopoietic Response|A hematopoietic response was defined as Hb rise >2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period|20 weeks|All patients that were evaluable per protocol.||Percentage of participants|||Number
146526|NCT00416598|Secondary|Relationship Between Busulfan Pharmacokinetics (Area Under the Curve) and Relapsed Disease|Results from busulfan pharmacokinetics will be pooled with those from CALGB 19808.|At baseline, after 2, 4, and 6 hours after the start of busulfan infusion||||||
146527|NCT00416598|Primary|Disease-free Survival (DFS) Rate at 1 Year|"For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL)."|At 1 year|||percentage of participants|||Number
146528|NCT00416598|Primary|Number of Participants Who Completed Maintenance Decitabine.|To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol.|Up to 5 years|||participants|||Number
146529|NCT00416572|Primary|Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).|Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.||units on a scale||Standard Deviation|Mean
146549|NCT00416455|Secondary|Comparison of the Diagnostic Sensitivity and Specificity of PET/CT Scan vs PET Scanning Alone in Identifying Metastases to Pelvic, Abdominal, and Combined (All Regions) Lymph Nodes||Up to 5 years||||||
146530|NCT00416572|Primary|Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).|Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.||units on a scale||Standard Deviation|Mean
146531|NCT00416572|Primary|Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.|Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).|All women who agreed to random assignment and completed all three assessments were retained in the analysis regardless of their level of group attendance.||units on a scale||Standard Deviation|Mean
146532|NCT00416520|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.|week12 minus week0|ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.||mg / dL||Standard Deviation|Mean
146533|NCT00416520|Primary|Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.|week16 minus week12|ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.||mg / dL||Standard Deviation|Mean
146534|NCT00416494|Other Pre-specified|Effect on Wound Angiogenesis||After study completion||||||
146535|NCT00416494|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion||||||
146536|NCT00416494|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.|||participants with adverse event|||Number
146537|NCT00416494|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.|||months||95% Confidence Interval|Median
146538|NCT00416494|Secondary|Disease Free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.|||months||95% Confidence Interval|Median
146539|NCT00416494|Secondary|Time to Progression|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From time of treatment until documented progression, assesed up to 60 months.|||months||95% Confidence Interval|Median
146540|NCT00416494|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who had restaging scans were included in the analysis.||percentage of participants with response||95% Confidence Interval|Number
146541|NCT00416455|Primary|Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis||Before surgery (DCT) and after surgery (pathology)|Abdominal positive and negative patients. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients.||percentage of patients||95% Confidence Interval|Number
146542|NCT00416455|Primary|Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis||Before surgery (FDG-PET-CT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients||percentage of patients||95% Confidence Interval|Number
146543|NCT00416455|Secondary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
146544|NCT00416455|Secondary|Cause(s) of Delay in the Initiation of Radiotherapy or Interruption in Radiotherapy in Patients With Locoregionally Advanced Cervical Cancer||Up to 5 years||||||
146545|NCT00416455|Secondary|Complications Associated With Extraperitoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy in Patients With Locoregionally Advanced Cervical Cancer||Up to 5 years||||||
146546|NCT00416455|Secondary|Accuracy of MRI in Determining the Depth of Myometrial Invasion and Involvement of Cervix in Patients With High-risk Endometrial Cancer||Up to 5 years||||||
146551|NCT00416455|Primary|Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen||Before surgery (FDG-PET-CT) and after surgery (pathology)|Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients||percentage of patients||95% Confidence Interval|Number
146552|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Activity|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of activity. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.~Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set||Units on a scale||Standard Error|Least Squares Mean
146553|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Bother|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of bother. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set||Units on a scale||Standard Error|Least Squares Mean
146554|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Fatigue|Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of fatigue. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.|Baseline and 52 weeks|Full analysis set.||Units on a scale||Standard Error|Least Squares Mean
146555|NCT00415532|Secondary|Change in ITP-PAQ Physical Health Domain of Symptoms|"Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of symptoms. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life.~Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates."|Baseline and 52 weeks|Full analysis set||Units on a scale||Standard Error|Least Squares Mean
146556|NCT00415532|Secondary|Percentage of Participants With Platelet Response|Platelet response was defined as platelet counts > 50 x 10^9/L, measured at each study visit (excluding those within 8 weeks of prior rescue medication use) up to the time of splenectomy or the end of initial treatment period, whichever occurred first.|Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|"Full analysis set. N indicates the number of participants with available data at each time point."||percentage of participants|||Number
146557|NCT00415532|Secondary|Time to Splenectomy|Time to splenectomy in days calculated from date of randomization to date of splenectomy, or censored at date of end of treatment visit if no splenectomy was done during treatment period.|52 weeks|Full analysis set||days||95% Confidence Interval|Median
146558|NCT00415532|Primary|Number of Participants With Treatment Failure During 52-Week Treatment Period|Treatment failure was defined by platelet counts ≤ 20 x 10^9/L for 4 consecutive weeks at the highest recommended dose and schedule, a major bleeding event, or change in therapy due to an intolerable side effect or bleeding symptom.|52 weeks|Full analysis set. Participants who discontinued study during treatment period prior to experiencing treatment failure were considered as having had treatment failure.||Participants|||Number
146559|NCT00415532|Primary|Number of Participants With Splenectomy During 52-Week Treatment Period|Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.|52 weeks|The Full Analysis set includes all randomized patients.||Participants|||Number
146560|NCT00415506|Primary|Improved Control of Inflammation|"For patients with scleritis, disease activity as measured by a modified grading system first described by McCluskey et al. (McCluskey and Wakefield 1987; McCluskey and Wakefield 1991). Improvement in scleritis activity will be defined as a reduction in this grading score of 2 or more, or an overall score of 4 or less by 24 weeks.~For patients with orbital inflammation, disease activity as measured by a modified grading system first devised by Werner (Werner 1977). Improvement in orbital inflammation will be defined as a reduction in this grading score of 2 or more, or an overall score of 3 or less."|24 weeks|||participants|||Number
146561|NCT00415506|Primary|Reduction of Medications|Reduction (decrease in dosage) of systemic corticosteroids or immunosuppressive therapy by at least 50% by 24 weeks.|24 Weeks|Only patients currently on systemic corticosteroids were analyzed for this outcome point.||participants|||Number
146562|NCT00415493|Primary|Net Proportional Change in Nasal Airway Resistance|Net proportional change in nasal airway resistance, pre- to post-exposure, cold air minus warm air day, calculated as a time-weighted average over the 1.0 h post-exposure. At each time point (pre-exposure, immediately post-exposure, and at 15-, 30-, 45- and 60 minutes post-exposure), nasal airway resistance (in Pa/L/sec) was measured in triplicate. The average of each of these measures was taken for each time point. The time-weighted average of these averages was then calculated for the post-exposure time points and compared with the baseline average for that individual on that testing day. The proportional change from baseline on that day was then calculated (unit-less measure). The difference between the pre-to-post change on the cold air day minus the pre-to-post change on the warm air day was then calculated (unit-less measure). The net proportional change corrects for both inter- and intra-individual variability, which in the case of nasal airway resistance is considerable.|One hour|||proportional change (unit-less)||Standard Error|Mean
146563|NCT00416195|Secondary|Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF||Baseline, Day 85 through Day 112|ITT population (LOCF)||Percent change||Full Range|Median
146706|NCT00413972|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Endpoint After 8 Weeks of Treatment||Baseline, 8 weeks|The number of participants for analysis included those from the ITT data set. 392 subjects were randomized in the study, but 3 of the randomized subjects were not treated and were excluded from the ITT data set. Therefore, only 389 subjects were included in the ITT data set.||percent change of LDL-C||Standard Error|Mean
146564|NCT00416195|Primary|Percentage of Responders During the Maintenance Phase|A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase.|Day 85 through Day 112|ITT population- all subjects in the Safety Population (all randomized subjects who took at least 1 dose of study drug) who had at least 2 weeks of baseline seizure frequency data and at least 1 week of seizure frequency data after baseline (LOCF - last observation carried forward)||Percentage of Participants|||Number
146565|NCT00416182|Secondary|Pulmonary Function|prior to surgery and end of study spirometry as measured by forced expiratory volume in 1 second (FEV1) percent predicted. The change over the course of the study (1 year minus baseline) is reported. A higher value indicates a better outcome.|baseline and 1 year|||percentage of predicted FEV1||Full Range|Mean
146566|NCT00416182|Secondary|Chronic Sinusitis Survey Score|pre-surgery and end of trial (12 months) Reduction in scores (baseline minus 1 year) are recorded The chronic sinusitis survey consists of 6 questions, ranges from 0-24, a lower score indicates the best possible outcome.|baseline and 1 year|||units on a scale||95% Confidence Interval|Mean
146567|NCT00416182|Primary|Improvement in Appearance of Nasal Passages/Sinuses|"periodic endoscopic photos of sinuses by ear-nose-throat (ENT) surgeon. The scale for scoring severity of disease ranges from 0 (best possible outcome) to 2 (worst possible outcome).~independent blinded scoring by 2 surgeons difference in scores pre and post are reported (1 year minus baseline)"|baseline and 1 year|||units||95% Confidence Interval|Mean
146568|NCT00416182|Primary|Computed Tomography Evidence of Less Sinus Disease|compare sinus CT pre-op (baseline) to one year after initiation of study drug Difference in pre and post scores by Lund-McKay scoring system are reported (1 year minus baseline) The Lund-Mackay scoring system was used to evaluate the extent and severity of sinusitis. The scale ranges from 0 (best possible outcome with complete lucency of all sinuses) to 24 (worst possible outcome with complete opacification of all sinuses)|baseline and 1 year|||units on a scale||95% Confidence Interval|Mean
146569|NCT00416078|Other Pre-specified|Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline|Frequency count of individuals placed in assisted living or nursing homes|baseline to end-of-follow-up (12 months from baseline)|Numbers vary; patients only at risk for out-of-home placement if alive and with data during follow-up periods||participants|||Number
146570|NCT00416078|Primary|Change in Caregiver Depression From Baseline|Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
146571|NCT00416078|Primary|Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline|Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver’s level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
146572|NCT00416078|Primary|Change in Frequency of Patient Problematic Behavioral Patterns From Baseline|Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.|baseline to end of treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
146573|NCT00416078|Primary|Change in Caregiver Burden From Baseline|Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.|baseline to end-of-treatment (6 months)|Data available for analyses vary due to missing data (lost to follow-up and deaths at different points in the protocol; incomplete forms)||units on a scale||Standard Error|Least Squares Mean
146574|NCT00416078|Secondary|Change in Caregiver Report of Patient Medication Adherence From Baseline|Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.|baseline to end-of-treatment (6 months)|measure was added to study while in process||units on a 1-5 scale||Standard Error|Least Squares Mean
146575|NCT00415909|Primary|Response Rate (Major and Complete Cytogenetic Response)|Rate is defined as number of participants with response of Major and Complete cytogenetic response out of total study participants. Response evaluated at one and 3 months from start of therapy, then every 3 months in patients with response, for one year, then every 6-12 months. Responses classified according to suppression of Philadelphia (Ph) chromosome by cytogenetic analysis: a) Complete cytogenetic response - Not Ph positive; b) Major cytogenetic response - Ph positive 1-34% of pretreatment value; c) Minor cytogenetic response - Ph positive 35-65% of pretreatment value; d) Minimal cytogenetic response - Ph positive 65-99% of pretreatment value; e) No cytogenetic response - Ph positive 100% of pretreatment value.|Evaluated at baseline (pretreatment) up to 12 months|All three patients received the planned 9 administrations of TALL-104.||percentage of participants|||Number
146576|NCT00415870|Secondary|to Assess Satisfaction With mDIET. Satisfaction Will be Measured by Subjective Ratings of Intervention Components and Ease of Use, and Objective Measures of Frequency of Use.||4 months||||||
146577|NCT00415870|Secondary|to Assess Compliance With Food Monitoring Activities (e.g, Type of Food, Amount) Via the Cell Phone. Compliance Will be Measured as a Percentage of Monitoring Logs Completed and Submitted Via Phone||4 months||||||
146578|NCT00415870|Primary|The Primary Outcome Will be the Effect of the mDIET System in Comparison to a Control Group on BMI Among Overweight Men and Women.||4 months|||kg||Standard Deviation|Mean
146707|NCT00413959|Secondary|Overall Survival|The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.|4 years|||percentage of participants|||Number
146579|NCT00415857|Secondary|Number of Participants With Immunologic Response|Immunologic Response (immune response) is defined as an increase of ≥ 0.5 PR1-HLA-A2 [human leukocyte antigen-A2 (HLA-A2)] tetramer cells / μl at the time of either the 3rd or 4th vaccination compared to the pre study absolute PR1-HLA-A2 tetramer cells / μl. Participants receive a total of 4 vaccinations over a period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). Participants assessed after 3rd and 4th vaccination for immunologic response.|Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18).|||participants|||Number
146580|NCT00415857|Primary|Molecular Response Rate|Molecular response rate is number of respondents compared to total participants. Molecular Response is defined as a greater than a one-log reduction of Breakpoint Cluster Region-Abelson Murine Leukemia (BCR-ABL) transcript levels by quantitative polymerase chain reaction (PCR) from the baseline level at the time vaccination was initiated, or a disappearance of BCR-ABL transcripts, as measured by reverse transcription polymerase chain reaction (RT-PCR), occurring within 6 months from the last vaccination. Participants receive a series of 4 vaccinations administered at 3-week intervals and the fourth (final) vaccination administered 3 months after the third vaccination with blood draw to test PCR following every 3 months to test the level of leukemia in the blood and to see if disease is responding to the vaccine.|Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period.|||percentage of participants|||Number
146581|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg||Baseline, Week 4, and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.||ng/mL||95% Confidence Interval|Geometric Mean
146582|NCT00415623|Secondary|Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg||Baseline, Week 4 and Week 8|Plasma concentration obtained after temporarily dosing discontinuation or not matched with the following conditions were excluded from the analysis; Steady-state condition: at least 80% drug compliance from the previous visit to the day of sampling; Trough condition: samples taken within ±10% of 24 hours from last dosing.||ng/mL||95% Confidence Interval|Geometric Mean
146583|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
146584|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
146585|NCT00415623|Secondary|Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
146586|NCT00415623|Secondary|Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8|Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old|Week 8|Full Analysis Set, Last Observation Carried Forward||participants|||Number
146587|NCT00415623|Secondary|Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)|Arithmetic mean of Week 6 & Week 8 by patient for “Change from baseline in DBP at Week 6” and “Change from baseline in DBP at Week 8”|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
146588|NCT00415623|Secondary|Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)|Arithmetic mean of Week 6 & Week 8 by patient for “Change from baseline in SBP at Week 6” and “Change from baseline in SBP at Week 8”|Baseline to Week 6 and Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
146589|NCT00415623|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8|Mean change in the trough DBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
146590|NCT00415623|Primary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 8|Mean change in the trough SBP|Baseline to Week 8|Full Analysis Set, Last Observation Carried Forward||mmHg||95% Confidence Interval|Least Squares Mean
146591|NCT00415610|Secondary|Tolerability, the Ability of Subjects to Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals|The ability to maintain the Specified Systolic Blood Pressure Range for the 18-24 Hour Period without Neurological Deterioration or Side Effects|3 months|All subjects were analyzed by treatment arm for the presence of SAEs, neurological deterioration, symptomatic or asymptomatic hematoma expansion, and mortality in-hospital or within 3 months. Pre-specified safety stopping rules were used. The nature and relatedness of events was examined and overseen by an external Data safety and Monitoring Board.||participants|||Number
146601|NCT00415194|Secondary|Progression-free Survival (PFS)|Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.|baseline to measured progressive disease up to 33 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||months||95% Confidence Interval|Median
146592|NCT00415610|Primary|Safety, Acute, as Determined by the Amount of Neurological Deteriorations During the 24 Hour Treatment Period, Plus the Number of Serious Adverse Events.|Safety outcomes were defined as the rate of neurological deterioration during treatment, and the rate of serious adverse events related to nicardipine. Safety stopping rules were pre-specified and were overseen by an external DSMB. Because SBP reduction may progress variably, additional analyses were also done to examine the relationship between SBP reduction and safety events more closely. The average SBP change at 2 hours after treatment initiation was compared among subjects who did or did not have neurological deterioration within 24 hours to evaluate the relationship between early SBP reduction and safety events. For each subject who experienced neurological deterioration (ND) within 24 hours, a graph of average hourly SBP and nicardipine dose was examined with timing of the ND noted. Therefore safety was evaluated according to assigned treatment group and also according to actual treatment magnitude within a clinically meaningful timeline for all subjects enrolled.|within the first 72 hours of treatment initiation|All subjects entered in the trial were followed and their data analyzed for safety measures. Not all subjects entered in the trial survived or remained in the trial to assess final outcomes at 1 or 3 months. Because safety stopping rules could not have triggered after 18 initial subjects, recruitment was adjusted to weight the intensive tier.||participants|||Number
146593|NCT00415610|Primary|Feasibility, the Ability to Achieve and Maintain the Systolic Blood Pressure Goals for Each Treatment Tier.|Feasibility of treatment was assessed by whether SBP reduction and maintenance within the respective target range was achieved (treatment success) or not (treatment failure), and secondarily by whether a significant difference between treatment arms was achieved. Treatment failure was defined based on the observed hourly hourly minimum SBP remaining greater than the upper limit of the target range for 2 consecutive hours after initiation of nicardipine infusion. Spontaneous decline of SBP below the lower limit of the specific tier was not considered treatment failure as all such declines were asymptomatic.The lower number in the more intensive treatment groups reflects in part the greater challenge of rapidly lowering systolic blood pressure to a more intensive (lower) range, as a higher number of treatment failures as pre-defined by meeting the SBP range goal within 3 hours of symptom onset in this group predictably occurred.|Within 3 hours of symptom onset and sustained through 18-24 hours.|All subjects were evaluated for achievement of the treatment goals.||participants|||Number
146594|NCT00415597|Secondary|Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|52 weeks|Patients with data at Week 52||Percent change||Standard Deviation|Mean
146595|NCT00415597|Secondary|Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain|Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.|12 weeks|Patients with data at Week 12||Percent change||Standard Deviation|Mean
146596|NCT00415597|Primary|Subjects With Treatment Emergent Adverse Events|Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).|up to 12 months|Patients treated with study drug||participants|||Number
146597|NCT00415194|Secondary|Correlation Between Biomarkers and Treatment Effect|"Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.~0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data."|Baseline|Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis.||correlation coefficient|||Number
146598|NCT00415194|Secondary|Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score|FACT-H&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant’s baseline score, or date of death from any cause. The MID for FACT H&N Total score was a decrease of 12 points.|Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months|Intention to treat (ITT) population with at least Baseline data.||Months||95% Confidence Interval|Median
146599|NCT00415194|Secondary|Duration of Response (DoR)|DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.|time of response to progressive disease up to 24 months|ITT population with a confirmed best response of complete response (CR) or partial response (PR).||Months||95% Confidence Interval|Median
146600|NCT00415194|Secondary|Percent of Participants With a Tumor Response (Response Rate)|Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100|Baseline to progressive disease or discontinuation of study treatment up to 11 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||Percentage of participants|||Number
146617|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visits.||percentage change in osteocalcin||Inter-Quartile Range|Median
146602|NCT00415194|Primary|Overall Survival (OS)|OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant’s last contact prior to that cut-off date.|Baseline to date of death from any cause up to 36 months|Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||Months||95% Confidence Interval|Median
146603|NCT00415168|Secondary|Number of Participants Who Died During the Study||During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||participants|||Number
146604|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) non-laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||participants|||Number
146605|NCT00415168|Secondary|Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy|Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death).|Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||participants|||Number
146606|NCT00415168|Secondary|Overall Survival|Defined as the time from baseline to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow up.|Baseline to date of death from any cause up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||months||95% Confidence Interval|Median
146607|NCT00415168|Secondary|Progression Free Survival (PFS)|Defined as time from baseline to the date of disease progression or death on study, whichever occurs first. The PFS 1 definition from the United States Food and Drug Administration (FDA) draft guidance on clinical endpoints was used (FDA 2005).|Baseline to measured progressive disease or death up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||months||95% Confidence Interval|Median
146608|NCT00415168|Secondary|Duration of Response|Measured from the time of first documentation of CR or PR (whichever status is first recorded) until the date of time to disease progression.|Time of response to progressive disease up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months|Full Analysis Set: This analysis set includes all data from all patients receiving at least one dose of the study drug.||months||95% Confidence Interval|Median
146609|NCT00415168|Primary|Percentage of Participants With Objective Response (Objective Response Rate)|Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria.|Baseline to time of response up to six or eight 21-day cycles of treatment|All patients enrolled in the study with a histologically confirmed diagnosis of adenocarcinoma of the gastric, disease status of measurable disease with presence of at least 1 measurable lesion, with no concurrent administration of any other tumor therapy or known or suspected brain metastasis who received at least 1 dose of study therapy.||percentage of responders||95% Confidence Interval|Number
146610|NCT00415051|Secondary|Genetic Stability - Characterize Viral Isolate (Plasma) Frequency|In vitro systems will be used to evaluate genetic stability (examining viremia levels in plasma by direct plaque assay techniques or by blind passage of plasma on Vero cells and sequencing the ribonucleic acid (RNA) and comparing these findings with those from the vaccine virus inoculum).|up to year|||Participants|||Count of Participants
146611|NCT00415051|Secondary|Immunogenicity Data (PRNT50) for RVP MP-12 Vaccine|Immune response will be assessed by measuring PRNT50 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12|||Days||Standard Deviation|Mean
146612|NCT00415051|Secondary|Immunogenicity Data (PRNT80) for RVP MP-12 Vaccine|Immune response will be assessed by measuring PRNT80 antibodies to RVF virus|Days 0, 1, 2, 3, 7, 10, 14 and 28, Months 3, 6 and 12|||Days||Standard Deviation|Mean
146613|NCT00415051|Primary|Safety Data for an Intramuscular (IM) Injection of RVF MP-12 Vaccine (SAE's/AE's)|AE's will be assessed through study completion. Safety will be evaluated by recording the frequency and severity of clinical reactions to the vaccine and by measuring complete blood counts and selected serum biochemistry (enzyme) values, rates of hospitalizations, and rates of lost duty/work time overall and by gender.|up to 1 year|||AE Events|||Number
146614|NCT00414973|Secondary|Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men|Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.|Baseline to 12 weeks and 24 weeks|Number of Intention to Treat patients with measurements at respective visit.||percentage change in osteocalcin||Inter-Quartile Range|Median
146615|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.||percentage change in total hip BMD||Standard Error|Least Squares Mean
146616|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
146618|NCT00414973|Secondary|Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women|Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward.||percentage change in total hip BMD||Standard Error|Least Squares Mean
146619|NCT00414973|Primary|Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women|Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.|Baseline to 24 weeks|Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward.||percentage change in lumbar spine BMD||Standard Error|Least Squares Mean
146620|NCT00414908|Other Pre-specified|"Change of Stool Frequency Between Original Baseline and End of Open-label Period (OL)"|Stool frequency is the average of the daily number of stools recorded during the OL period. Lower values indicate a better response. Change was calculated as (OL stool frequency - Baseline stool frequency).|27 weeks|This analysis is done on the Open-Label period of 6 months.||Number||Standard Deviation|Mean
146621|NCT00414908|Secondary|Flatulence at the End of Double-blind Period|4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Participants|||Number
146622|NCT00414908|Secondary|Stool Consistency at the End of the Double-blind Period|4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Participants|||Number
146623|NCT00414908|Secondary|Abdominal Pain at the End of the Double-blind Period.|4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Participants|||Number
146624|NCT00414908|Secondary|Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period|Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Number||Standard Error|Least Squares Mean
146625|NCT00414908|Secondary|Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).|End of double-period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Grammes||Standard Error|Least Squares Mean
146626|NCT00414908|Secondary|Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.|Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Grammes||Standard Error|Least Squares Mean
146627|NCT00414908|Secondary|Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.|The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Percentage||Standard Deviation|Mean
146628|NCT00414908|Primary|Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.|"The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.~Change is calculated as (DB CFA-Baseline CFA)."|End of double-blind period (5-7 days)|The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement.||Percentage||Standard Deviation|Mean
146629|NCT00414817|Secondary|Rate of Acute Health Care Visits for Asthma|annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.|Measured over 19 months of follow-up|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.||number of events per year||Standard Deviation|Mean
146630|NCT00414817|Secondary|Juniper Asthma Quality of Life Questionnaire (Global Score)|Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.|Measured at 19 months|We assessed this outcome on a random sample of study participants that over-sampled intervention participants. All were existing users of ICS at the outset of the study who qualified for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.||unitless scale ranging from 1-7||Standard Deviation|Mean
146669|NCT00414596|Secondary|Recurrence for Significant (VRS Greater Than or Equal to 4) LBP Following Completion of 6 Weeks of DRX9000 Treatment.|The number of Subjects reporting VRS greater than or equal to 4 for LBP following completion of 6 weeks of DRX9000 treatment will be recorded.|Six weeks|||participants|||Number
146631|NCT00414817|Primary|Modified Medication Possession Ratio|We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days’ supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days’ supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.|Measured over 19 months|Study participants who were existing users of ICS at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.||fraction of days with medication||Standard Deviation|Mean
146632|NCT00414726|Primary|Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|4 hours after starting treatment|||0-4 hour change in NIHSS score||95% Confidence Interval|Mean
146633|NCT00414726|Primary|Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups.|The NIHSS score ranges from 0 (best score) to 42 (worst score).|24 hours|||0-24 hour change in NIHSS score||95% Confidence Interval|Mean
146634|NCT00414700|Post-Hoc|Number of Treatment Failures at 60 Months Post-surgery|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 60 months.~The index lesion is the lesion that was initially treated in the study."|60 months|||participants|||Number
146635|NCT00414700|Post-Hoc|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 60 Months|Patient-administered instrument to assess the patients opinion about their knee and associated problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.|60 months|FAS population with imputation for treatment failures by LOCF||units on a scale||Standard Error|Mean
146636|NCT00414700|Secondary|Safety: Adverse Events|Side effects are recorded as the number of patients with adverse events. These events are coded according to the Medical Dictionary for Regulatory Affairs (MedDRA terms).|continuous up to 60 months|||participants|||Number
146637|NCT00414700|Secondary|Number of Treatment Failures at 36 Months|"Participants with failed treatment - defined as the number of patients who underwent a reintervention of the index lesion - at 36 months.~The index lesion is the lesion that was initially treated in the study."|Continuous|||Participants|||Number
146638|NCT00414700|Secondary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 36 Months|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains: Activities of Daily Living, Quality of Life, Symptoms and Stiffness Pain; Sports not included) at 36 months (change from baseline). Best = 100; worst = 0.|Change from baseline in Overall KOOS at 36 months post-surgery|||Units on a scale||Standard Error|Mean
146639|NCT00414700|Primary|Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12-18 Months (Average)|Overall Knee injury and Osteoarthritis Outcome score (average of 4 KOOS subdomains, Sports not included) at the average of 12-18 months (calculated by averaging change from baseline measurements at 12 and 18 months). Best score = 100; worst score = 0. The analysis was the average of the change from baseline at the 12 and 18 months timepoints.|Average change from baseline in Overall KOOS at 12-18 months post-surgery|FAS (with LOCF for treatment failures)||points on a scale (0-100)||Standard Error|Least Squares Mean
146640|NCT00414700|Primary|Overall Histology Assessment on First Subscale of ICRS II Score|Overall histology assessment of cartilage repair, first subscale of International Cartilage Repair Society II (ICRS II) score by two blinded independant histopathologists on a visual analogue scale (VAS 0-100mm) from worst (0) to best (100)|12 months post-surgery|FAS||Points on a scale||Standard Error|Least Squares Mean
146641|NCT00414700|Primary|Histomorphometry Safranin-O + Anti-Collagen II Antibody Staining|Histomorphometry on end point biopsies at 12 months post-surgery. Safranin-O (ratio 0-1)+ anti-Collagen II antibody (ratio 0-1) stain signal expressed as a ratio of the total cartilage surface area (Saf O + anti Coll II divided by total surface = ratio 0-2). Safranin-O stains proteoglycans and anti-Collagen II antibody reflects the presence of Collagen II.|12 months post-surgery|Full Analysis Set (FAS)||Ratio||Standard Error|Least Squares Mean
146642|NCT00414661|Other Pre-specified|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, 12, 18, 24|Safety analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for the measure and 'n' signifies participants evaluable at each time point for each arm respectively.||units on a scale||Standard Deviation|Mean
146643|NCT00414661|Primary|Incidence of Important Infections|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.||Infections per 100 person-years||95% Confidence Interval|Number
146670|NCT00414596|Primary|Post-treatment Numerical Pain Intensity Rating Scale (VRS), Which is a Scale From 0-10 (0=no Pain, 10= Worst Pain)|The numerical results of the post-treatment verbal numerical pain intensity rating scale (VRS) following completion of a standard six week series of 20 DRX9000 treatments.|Six weeks|||units on a scale||Inter-Quartile Range|Median
146644|NCT00414661|Primary|Incidence of Lymphoma|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.||Lymphoma per 100 person-years||95% Confidence Interval|Number
146645|NCT00414661|Primary|Incidence of Lymphoproliferative Disorders (LPD)|Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.|Up to Month 24|Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.||LPD per 100 person-years||95% Confidence Interval|Number
146646|NCT00414635|Secondary|Deviation From FOTO Schedule by One Extra Dose|Percentage of FOTO participants who took a dose during weekend planned interuption period|4, 12, 24 weeks|||Percentage of Participants|||Number
146647|NCT00414635|Secondary|Self-reported Adherence Summary in Both Arms|Percentage of participants who missed one or more doses in weekly regimen.|4, 12 and 24 weeks|||percentage of participants|||Number
146648|NCT00414635|Secondary|Trough Blood Levels of Efavirenz in Both Arms|blood levels of efavirenz measured at 60 hours post last dose in FOTO arm and 12 hours post last dose in daily arm (control)|12 or 60 hours|||Percentage of Participants|||Number
146649|NCT00414635|Secondary|"Absolute Number of Virological Blip Events Occurring Over 24 Weeks"|"Total number of blip events in each arm. Blips are defined as HIV RNA > 50 and < 200 cps/ml"|Baseline to week 24|||blip events|||Number
146650|NCT00414635|Secondary|Quality of Life|"Participant preference of antiretroviral (ART) regimen determined on a scale ranging from 0 to 10. O was defined as I Perfer taking HIV medications 7 days/week and 10 was defined as I perfer 5 days on and 2 days off. We present results of a single question on quality of life experienced while on their study ART regimen."|4 weeks|The questionnaire was only applicable to FOTO arm||Units on a Scale||Inter-Quartile Range|Median
146651|NCT00414635|Secondary|Mean CD4+ T-cell Count Increases From Baseline to Week 24.||Baseline to Week 24|||cells/ml||95% Confidence Interval|Mean
146652|NCT00414635|Primary|Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)|Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)|24 weeks|Per protocol||Percentage of Participants|||Number
146653|NCT00414609|Secondary|Extension Study: Percentage of Participants With Specified Criteria in Selected Labs by Laboratory Parameter|"Fasting blood samples were collected throughout the study and were analyzed at a central laboratory. Percentage of participants with the following clinically significant laboratory values are reported:~Potassium <3.5 mmol/L; Low value (Normal reference range: 3.5- 5.3)~Potassium >5.5 mmol/L and Potassium >6.0 mmol/L; High values (Normal reference range: 3.5-5.3)~Creatinine >176.8 μmol/L; High value (Normal reference range= Male: 62- 106 and Female 44- 80)~Blood Urea Nitrogen (BUN) >14.28; High value (Normal reference range: 2.1- 8.9)"|24 Months|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."||Percentage of participants|||Number
146654|NCT00414609|Secondary|Extension Study: Percentage of Participants With Orthostatic Blood Pressure Change|Orthostatic blood pressure change is defined as a decrease of at least 20 mmHg in systolic blood pressure or a decrease of at least 10 mmHg in diastolic blood pressure when a patient moves from a sitting position to a standing position. A patient could show orthostatic blood pressure change at more than one visit. End of study is Month 24 or early discontinuation.|Baseline (Day 0 Extension study), Week 2, Months 1, 3, 6, 9,16, 20, 24|"Extension population (considered as Safety population) consisted of all enrolled patients who received at least one dose of study medication in the extension study. n in each of the categories is the number of participants with data available at the given time-point."||Percentage of Participants|||Number
146655|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 12|Change from baseline to Month 12 in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.||percent of blood pumped from LV chamber||Standard Deviation|Mean
146656|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 12|Change from baseline to Month 12 in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. LVEDV is a measurement of the volume of blood in the heart’s left ventricular chamber at the beginning of the chamber’s filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal.|Baseline (extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.||Milliliter (mL)||Standard Deviation|Mean
146657|NCT00414609|Secondary|Extension Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 12|Change from baseline to Month 12 in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart’s left ventricular chamber at the end of the heart’s contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal.|Baseline(extension study), Month 12 (extension study)|Echocardiogram Analysis Set consisting of all patients in the extension population who had acceptable ECHO measurements at extension baseline and Month 12.||Milliliter (mL)||Standard Deviation|Mean
146671|NCT00414544|Secondary|Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months||3, 9 and 12 months||||||
146672|NCT00414544|Primary|Adverse Event Reporting||6 months||||||
146658|NCT00414609|Primary|Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Extension study (24 weeks)|Extension Population (considered as Safety population) consisting of all enrolled patients who received at least one dose of study medication in the extension study.||Percentage of participants|||Number
146659|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Wall Motion Score (WMS) as Measured by Echocardiography|Change from baseline to end of study in Wall Motion Score (WMS) as measured by echocardiography. WMS was obtained by examining multiple segments of the left ventricle and assigning each segment a score based on myocardial thickening: 1 for normal, 2 for hypokinetic; 3 for akinetic; and 4 for dyskinetic. The WMS was obtained as the average score for the segments visualized and was calculated by the echocardiography lab. Possible values range from 1 to 5. Higher scores are considered worse. Baseline WMS was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||Scores on a scale||Standard Error|Least Squares Mean
146660|NCT00414609|Secondary|Core Study: Change From Baseline to End of Study in Infarction Segment Length (ISL) as Measured by Echocardiography|Change from baseline to end of study in infarction segment length (ISL) (%) as measured by echocardiography. This is the length of the myocardial infarction segment as a percentage of the total cavity perimeter length as calculated by the echocardiography lab. Baseline ISL was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||percent of total cavity perimeter length||Standard Error|Least Squares Mean
146661|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|Change from baseline to end of study in left ventricular ejection fraction (LVEF) (%) as measured by echocardiography. LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. This measurement was made by the echocardiography lab. Ejection fraction percentages > 55% are considered normal. Baseline LVEF was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment )|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||percent of blood pumped from LV chamber||Standard Error|Least Squares Mean
146662|NCT00414609|Secondary|Core Study: Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)|Change from baseline to end of study in left ventricular end diastolic volume (LVEDV) as measured by echocardiography. (LVEDV) is a measurement of the volume of blood in the heart’s left ventricular chamber at the beginning of the chamber’s filling with blood. This measurement was made by the echocardiography lab. LVEDV values between 67 to 155 mL for men and 56 to 104 mL for women are considered normal. Baseline LVEDV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set: Patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment.||mL||Standard Error|Least Squares Mean
146663|NCT00414609|Secondary|Core Study: Time to First Occurrence for the Composite Endpoints of Echocardiogram and Adjudicated Outcomes|Composite outcome 1 included: Cardiovascular (CV) Death, hospitalization for heart failure (HF), or absolute reduction in Left Ventricular Ejection Fraction (LVEF) greater than 6%. Composite outcome 2 included: CV Death, hospitalization for HF, recurrent Myocardial Infarction, Stroke, or Resuscitated Sudden Death. LVEF was measured at baseline and final visit. All other events were adjudicated by a blinded external committee. Each composite endpoint analysis was based on (a) the percent of patients with that endpoint and (b) days in study to 1st event (or last exposure if no event occurred).|LVEF was measured at baseline and at final visit (after 26 to 36 weeks of treatment). Other endpoint components were assessed from randomization until the end of the study (week 36).|Full Analysis Set (FAS) – All randomized patients who either (a) received study drug or (b) did not receive study drug but were not disqualified from randomization.||Percentage of participants|||Number
146664|NCT00414609|Primary|Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study.|Change from baseline to end of study in left ventricular end systolic volume (LVESV) as measured by echocardiography. LVESV is a measurement of the volume of blood in the heart’s left ventricular chamber at the end of the heart’s contraction. This measurement was made by the echocardiography lab. LVESV values between 22 to 58 mL for men and 19-49 mL for women are considered normal. Baseline LVESV was a covariate.|Baseline and final visit (after 26 to 36 weeks of treatment)|Echocardiogram evaluable set (patients who had acceptable echocardiogram measurements both at baseline and at post-baseline after receiving at least 26 weeks of treatment)||mL||Standard Error|Least Squares Mean
146665|NCT00414596|Secondary|Number of Patients Who Withdraw From Study.|Total number of patients who withdrew during the 6 weeks of treatment.|6 weeks|||participants|||Number
146666|NCT00414596|Secondary|Number of Adverse Events Following 6 Weeks of DRX9000 Treatment.|Total number of adverse events reported following 6 weeks of DRX9000 treatment.|Six weeks|All subjects enrolled were included in the analysis. No adverse events related to study device were reported.||Number of Adverse Events|||Number
146667|NCT00414596|Secondary|Patient's Satisfaction With Treatment Procedures Following 6 Weeks of DRX9000 Treatment.|Patient's satisfaction with treatment procedures following 6 weeks of DRX9000 treatment was measured on a scale from 0-10 (0= very unsatisfied, 10=very satisfied).|Six weeks|||units on a scale||Inter-Quartile Range|Mean
146668|NCT00414596|Secondary|Change in Functional Capacity From Baseline to Six Weeks (The Revised Oswestry Pain Questionaire)|Subject functional capacity following 6 weeks of DRX9000 treatment will be measured as a numerical score by the Revised Oswestry Pain Questionaire (scale 0-50, 0=pain without effects). Functional capacity was assessed at Baseline, 3 Weeks and 6 Weeks.|Six weeks|||Change in units of scale||Inter-Quartile Range|Median
146673|NCT00414544|Primary|Change in Wrinkle Severity Rating Scale|To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.|baseline and 6 months|Analysis was intention to treat (ITT) and each subject received both CosmetaLife and Control (Restylane) injections into contralateral nasolabial folds, respectively. WSRS units (change from baseline analyzed)||units on scale||Standard Deviation|Mean
146674|NCT00414518|Primary|Viral Set Point|set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus|Throughout study|||Log 10 copies virus/ml||Standard Deviation|Mean
146675|NCT00414518|Primary|Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome||At Week 24|||participants|||Number
146676|NCT00414518|Primary|Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms||At Week 24|||Log 10 copies of virus/ml||Standard Deviation|Mean
146677|NCT00414466|Primary|Number of Participants With Treatment-emergent Adverse Events|Evaluation of adverse event profiles between placebo and active treatment groups.|Randomization to Post-randomization Day 29 (includes dose reduction)|All randomized subjects were included as per protocol.||Participants|||Number
146678|NCT00414466|Secondary|Responder Analysis Between Active Treatment and Placebo Groups.|Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.|Baseline to Post-randomization Day 22|All 170 randomized subjects were included as per protocol. Subjects experiencing an intolerable adverse event, discontinuing due to an adverse event or lack of efficacy, or not providing data were considered non-responders.||Participants|||Number
146679|NCT00414466|Primary|Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.|Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.|Baseline and Post-randomization Day 22|Primary efficacy analysis was performed on the 167 randomized subjects that completed at least 4 days of the electronic pain diary during the last 7 days prior to the Day 22 or Early Termination Visit as per protocol. No imputation methods were used.||Scores on a scale||Standard Deviation|Mean
146680|NCT00414453|Secondary|Kurtzke Expanded Disability Status Scale|Subject completes questionaire on functional status|Occurs at Visit 1|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146681|NCT00414453|Secondary|Patient Global Impression of Change Scale|Subject completes patient global impression questionaire of change scale|Occurs Visit 3, 4, 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146682|NCT00414453|Secondary|Short-Form McGill Pain Questionnaire|Subject completes short form McGill Pain questionaire|Occurs Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146683|NCT00414453|Secondary|Short-form Health Survey 36 (SF-36)|Subject completes short form health survey 36 questionaire|Occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146684|NCT00414453|Secondary|Beck Depression Inventory|Subject completes Beck questionaire|occurs at Visit 1, 3, 4 and 5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146685|NCT00414453|Secondary|Daily Diary Sleep Interference Ratings|Subject identifies degree of sleep interference on a daily basis|daily|Data was not analyzed because we did not reach our enrollment goal and the study was terminated.. Data was not analyzed because we the data is locked and is not available.|||||
146686|NCT00414453|Secondary|Brief Pain Inventory Interference Items|subject completes the brief pain questionaire|occurs Visit 1, 3,4,5|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146687|NCT00414453|Secondary|Safety (i.e., Number of Serious Adverse Events)|Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales|rating and review of any adverse events occurs at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146688|NCT00414453|Secondary|Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)|subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries|rating of adverse events occur at each visit|Data was not analyzed because we did not reach our enrollment goal and the study was terminated. Data was not analyzed because we the data is locked and is not available.|||||
146689|NCT00414453|Primary|Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period|subject identifies daily pain rating during final week of each treatment period using a numeric rating scale|Daily|Data was not analyzed because we the data is locked and is not available.|||||
146690|NCT00414440|Secondary|Calculated GFR (mL/Min/1.73 m^2), Change From Baseline by Visit|Change in renal function was assessed by the Glomerular Filtration Rate (GFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 3, 6, 9, 12, 18 and 24|ITT set, observed cases||mL/min/1.73m^2|Participants|Standard Deviation|Mean
146692|NCT00414440|Secondary|Calculated GFR, Change From Baseline at Month 60 by Baseline cGFR|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.|Months 24, 36, 48 and 60|ITT||mL/min/1.73 m^2||Standard Deviation|Mean
146693|NCT00414440|Secondary|Course of Calculated GFR (mL/Min/1.73 m^2) From Month 24 to Month 60|Course of calculated GFR (mL/min/1.73 m^2) at Months 24, 36, 48 and 60|Months 24, 36, 48 and 60|ITT||mL/min/1.73 m^2||Standard Deviation|Mean
146694|NCT00414440|Primary|Primary Efficacy Analysis of Total Kidney Volume (mITT Set, Multiple Imputation)|Everolimus (RAD001) compared to placebo with respect to the change from baseline in total kidney volume at Month 24.|Baseline, Month 24|mITT set||mL||95% Confidence Interval|Mean
146695|NCT00414388|Secondary|PSA -Biochemical Response|PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.|1-10 months|||percentage of participants|||Number
146696|NCT00414388|Secondary|Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).|Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.|3-10 months|||percentage of patients|||Number
146697|NCT00414388|Primary|Percentage of Patients Needing a Dose Reduction.|The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%|participants were followed for an average of 25 months|15 patients required dose reductions.||percentage of participants|||Number
146698|NCT00414310|Secondary|Participant Response Durations/Length of Survival|The following scoring system used for patient outcomes: For a patient who died, his/her score is the actual number of weeks he/she survived since the beginning of treatment. For a patient who is still alive, his/her score is the number of weeks he/she has survived since the beginning of treatment plus a number which depends on his/her current status. Based on the median survival weeks in historical data, these numbers will be 40 for those patients who go off-study (resistant), 60 for patients without response but on study, 75 for patients with CRi or PR, and 110 for patients who have achieved CR.|1 Year or to disease progression||||||
146699|NCT00414310|Primary|Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML|Complete Remission (CR): CR defined as normalization of peripheral blood and bone marrow with < 5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 10^9/ L, and a platelet count > 100 x 10^9/L). CRi or complete remission with incomplete platelet recovery is defined as above, but platelets <100 x 109/L. Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. Clinical Benefit: In MDS/CMML, as per International Working Group (IWG) criteria, platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10^9/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 10^9/L. In addition to IWG criteria, in AML, a decrease in bone marrow blasts to <5% also considered clinical benefit.|1 Year|One enrolled participant was not treated.||Percentage of Participants|||Number
146700|NCT00414206|Primary|Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.||Baseline to Week 48|A modified MITT population was used, which was prospectively defined as all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy (visual acuity) assessment.||Percent of subjects|||Number
146701|NCT00414167|Secondary|Percent BMI Loss|Percent loss in Body Mass Index|8 weeks (baseline and 8 weeks)|Baseline values imputed forward for missing data.||Percent loss||Standard Deviation|Mean
146702|NCT00414167|Primary|Frequency of Binge Eating Episodes||One week (at post treatment)|Baseline forward imputation for missing data.||episodes/week||Standard Deviation|Mean
146703|NCT00414050|Secondary|Induced (Effected) Geometric Mean Titer for Modified Process Vaccine (5 µg and 10 µg), RECOMBIVAX Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®|Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.|7 months|Per protocol. Fewer participants were analyzed than planned as noted in the previous text and table.||mIU/mL||95% Confidence Interval|Geometric Mean
146704|NCT00414050|Primary|The Number of Seroresponders to the Modified Process Hepatitis B Vaccine (5µg and 10 µg Dose), RECOMBIVAX-HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®|The number of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10mIU/mL.|7 months|The Per-protocol Population is defined as the participants able to complete the study as defined by the protocol. Fewer participants were analyzed than planned. A total of 1609 participants were included in the per protocol analysis. A total of 1687 participants completed the three doses of vaccine.||participants|||Number
146705|NCT00414011|Primary|Corneal Epithelial Healing Time|patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)|3 to 4 days after surgery|||days to complete epithelial healing|Participants|Full Range|Median
146710|NCT00413920|Secondary|Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status|"The number of participants with treatment failure defined as a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up at 3 months by graft recovery status.~Delayed graft function is defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.~Slow graft function is defined as a serum creatinine value > 250 µmol/L at day 5."|Month 3|Intent-to-treat population. N in the categories is the number of participants from the total population that fit into that category for each arm/group. For example: in the Delayed Graft Function category there were 25 participants in the Without steroid group and 24 participants in the With Steroid Group.||Number of participants|||Number
146711|NCT00413920|Secondary|Number of Participants With Subclinical Histological Rejections|The number of participants with subclinical histological rejections was determined by renal biopsy screening at 3 months in 125 patients, providing adequate samples for 112 biopsies.|Month 3|Intent-to-treat population on whom biopsies were performed at 3 months.||Number of participants|||Number
146712|NCT00413920|Secondary|Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months|A treatment failure is a Biopsy Proven Acute Rejection (BPAR), a graft loss, a death, or a loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: The allograft will be presumed lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|Month 3|Intent-to-treat population||Number of participants|||Number
146713|NCT00413920|Secondary|The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months|If a participant experienced several BPAR, only the rejection with highest grade is taken into account. Only events that occurred before study treatment discontinuation are taken into account. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection.|Month 6|Intent-to-treat population||Number of participants|||Number
146714|NCT00413920|Primary|Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation|Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.|6 months post transplantation|Intent-to-treat population||Number of participants|||Number
146715|NCT00413894|Secondary|Percentage of Participants Requiring Erythrocyte Transfusions||Visits 1 to 10 (Months -2 to 8)|Safety Population (SAF): All participants who received at least one dose of study medication independent from whether they completed the study or not were included into the safety analysis.||percentage of participants|||Number
146716|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Screening Phase|Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.|Visits 1 to 2 (Months -2 to -1)|ITT Population||percentage of participants|||Number
146717|NCT00413894|Secondary|Percentage of Participants With Hb Fluctuations Within Evaluation Phase|Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.|Visits 8 to 10 (Months 6 to 8)|ITT population||percentage of participants|||Number
146718|NCT00413894|Secondary|Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels|"Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.~Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted."|Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8)|ITT Population;||percentage of participants|||Number
146719|NCT00413894|Secondary|Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category||percentage of participants|||Number
146720|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 1 to 2 (Months -2 to -1)|ITT Population; n = number of participants in the specified category||percentage of participants|||Number
146721|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population||percentage of participants|||Number
146773|NCT00413634|Primary|Maximum Plasma Concentration (Cmax) of Agrylin||over 1 day|PK population (defined as all patients with post-dose drug concentration data)||ng/ml||Standard Deviation|Geometric Mean
146722|NCT00413894|Secondary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase||Visits 1 to 2 (Months -2 to -1)|ITT Population: All participants having received at least one dose of study medication and having at least one Hb value measurement under C.E.R.A. were included.||percentage of participants|||Number
146723|NCT00413894|Primary|Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; n = number of participants in the specified category||percentage of participants|||Number
146724|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase|Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.|Visits 8 to 10 (Months 6 to 8)|CP; number (n) equals (=) number of participants in the specified category||percentage of participants|||Number
146725|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|CP||percentage of participants|||Number
146726|NCT00413894|Primary|Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase||Visits 8 to 10 (Months 6 to 8)|Completer Population (CP) included only participants who completed the study until Visit 10 (Month 8).||percentage of participants|||Number
146727|NCT00413660|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET|FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146728|NCT00413660|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146729|NCT00413660|Secondary|Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146730|NCT00413660|Secondary|Medical Outcome Study- Sleep Scale (MOS-SS)|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 2, 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146731|NCT00413660|Secondary|Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146774|NCT00413582|Secondary|Time in the Operating Room||1 week|||hours||Standard Deviation|Mean
146775|NCT00413582|Primary|Length of Hospitalization||1 week|||days||Standard Deviation|Mean
146732|NCT00413660|Secondary|Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146733|NCT00413660|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146734|NCT00413660|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 12, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146735|NCT00413660|Secondary|Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)|DAS28-3 (CRP) defined remission was classified as a score of <2.6.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||percentage of participants|||Number
146736|NCT00413660|Secondary|Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||percentage of participants|||Number
146737|NCT00413660|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146738|NCT00413660|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146739|NCT00413660|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mg/dL||Standard Deviation|Mean
146740|NCT00413660|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mg/dL||Standard Deviation|Mean
146790|NCT00413400|Secondary|Glucose Tolerance|Fasting glucose (mg/dL) at 6mo|6 months|||mg/dL||Standard Error|Mean
146741|NCT00413660|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146742|NCT00413660|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||units on a scale||Standard Deviation|Mean
146743|NCT00413660|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
146744|NCT00413660|Secondary|Physician Global Assessment of Arthritis|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
146745|NCT00413660|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
146746|NCT00413660|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
146747|NCT00413660|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
146748|NCT00413660|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||mm||Standard Deviation|Mean
146749|NCT00413660|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||swollen joints||Standard Deviation|Mean
146750|NCT00413660|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||swollen joints||Standard Deviation|Mean
146791|NCT00413400|Primary|Adiponectin|The ratio of circulating high molecular weight (HMW) adiponectin to total adiponectin ratio (HMW:total Adiponectin) at 6 months is reported.|6 months|||(ratio)||Standard Error|Mean
146792|NCT00413400|Primary|Interleukin-6 (IL-6)|6 month value of IL-6 (pg/mL)|6 months|||pg/mL||Standard Error|Mean
146751|NCT00413660|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||tender joints||Standard Deviation|Mean
146752|NCT00413660|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET|"FAS included all randomized participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants evaluable for this measure and “n” signifies participants evaluable at specific time points for each arm group, respectively."||tender joints||Standard Deviation|Mean
146753|NCT00413660|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Last Observation Carried Forward (LOCF).||units on a scale||Standard Deviation|Mean
146754|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
146755|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 12, 16, 20, 24/ET|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
146756|NCT00413660|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)|FAS included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using BOCF. Here “n” is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
146757|NCT00413660|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment. Missing values were imputed using Baseline Observation Carried Forward (BOCF).||percentage of participants|||Number
146758|NCT00413634|Secondary|Diastolic Blood Pressure|Diastolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population||mmHg||Standard Deviation|Mean
146759|NCT00413634|Secondary|Systolic Blood Pressure|Systolic blood pressures in patients with ET receiving Agrylin|over 1 day|Safety population||mmHg||Standard Deviation|Mean
146760|NCT00413634|Primary|Vz/F of Active Metabolite||over 1 day|PK population||L||Standard Deviation|Geometric Mean
146761|NCT00413634|Primary|CL/F of Active Metabolite||over 1 day|PK population||L/h||Standard Deviation|Geometric Mean
146762|NCT00413634|Primary|T 1/2 of Active Metabolite||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
146763|NCT00413634|Primary|AUC of Active Metabolite||over 1 day|PK population||ng.h/ml||Standard Deviation|Geometric Mean
146764|NCT00413634|Primary|Tmax of Active Metabolite||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
146765|NCT00413634|Primary|Cmax of Active Metabolite|An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.|over 1 day|PK population||ng/ml||Standard Deviation|Geometric Mean
146766|NCT00413634|Primary|Volume of Distribution (Vz/F) of Agrylin||over 1 day|PK population||L||Standard Deviation|Geometric Mean
146767|NCT00413634|Primary|Total Clearance (CL/F) of Agrylin||over 1 day|PK population||L/h||Standard Deviation|Geometric Mean
146768|NCT00413634|Primary|Terminal Half-life (T 1/2) of Agrylin||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
146769|NCT00413634|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin||over 1 day|PK population||ng.h/ml||Standard Deviation|Geometric Mean
146770|NCT00413634|Primary|Time of Maximum Plasma Concentration (Tmax) of Agrylin||over 1 day|PK population||hours||Standard Deviation|Geometric Mean
146776|NCT00413478|Primary|Tumor Response Rate (Complete, Partial) of Azacytidine|Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count > 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be > 11g/dl without transfusions. Lymphocyte count <4000/micL. On bone marrow aspirate lymphocyte % should be <30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils > 1500/ micL or >50 % improvement from baseline, platelet count >100,000/micL or >50 % improvement from baseline. Hemoglobin >11g/dl or >50% improvement from baseline. A reduction of >50% in Leukocyte count or <30 % lymphocytes with residual disease on biopsy for nodular PR.|3 to 8 weeks treatment cycles, continuation up to 1 year|||percentage of participants|||Number
146777|NCT00413413|Secondary|Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)|Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
146778|NCT00413413|Secondary|Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)|Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|End of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
146779|NCT00413413|Secondary|Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)|A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
146780|NCT00413413|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
146781|NCT00413413|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
146782|NCT00413400|Secondary|Adipocyte Messenger Ribonucleic Acid (mRNA) Levels of Adipocytokines Including Tumor Necrosis Factor (TNF) -Alpha|fold-change in subcutaneous adipose tissue expression of TNF-alpha (mRNA) after 6 months|6 months|||fold-change||Standard Error|Mean
146783|NCT00413400|Secondary|Lipid Levels|total cholesterol (mg/dL) at 6 months|6 months|||mg/dL||Standard Error|Mean
146784|NCT00413400|Secondary|Other Adipocytokines|circulating resistin at 6 months|6 months|||ng/mL||Standard Error|Mean
146785|NCT00413400|Secondary|Tumor Necrosis Factor (TNF) Receptor|Circulating concentrations of Tumor necrosis factor receptor 2 (TNFR2) at 6 months|6 months|||pg/mL||Standard Error|Mean
146786|NCT00413400|Secondary|Body Composition|6 month visceral adipose tissue (cm^2) - cross-sectional area of the visceral adipose tissue at the level of the 4th lumbar vertebrae was measured using single-slice abdominal computed tomography (CT) scan|6 months|||cm^2||Standard Error|Mean
146787|NCT00413400|Secondary|Cardiac Echo Ejection Fraction (EF)|change in EF (6mo - baseline). Please note that the value given is the absolute change in EF (which has units of percent), not the percent change in the variable.|Baseline to 6 months|||percent||Standard Error|Mean
146788|NCT00413400|Secondary|White Blood Cell (WBC) Count|Change in WBC during study (WBC at six months minus WBC at baseline)|Baseline to 6 months|||th/cumm||Standard Error|Mean
146789|NCT00413400|Secondary|Endothelial Function|Reactive Hyperemia Index (RHI) using peripheral artery tonometry (using Endo-PAT 2000). Peripheral artery tonometry measures blood flow in the tip of the index finger at baseline and in response to vaso-occlusion (inflated blood pressure cuff). The reactive hyperemia index is an index of vasodilation after occlusion compared to baseline. A higher value indicates better vasoreactivity. As this is a relatively new test, there are no thoroughly validated clinically utilized norms.|6 months|||(index)||Standard Error|Mean
146795|NCT00413374|Primary|Recurrent VTE|Major clotting complication (recurrent VTE) as defined as recurrent acute pulmonary embolism confirmed on chest CT or recurrent deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy.|30 Days|||participants|||Number
146796|NCT00413374|Primary|Major Bleeding Complication|Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.|30 Days|||participants|||Number
146797|NCT00413335|Primary|Mean Percent Change From Baseline in Hepatic Fat Fraction (HFF)|It refers to the percent changes of hepatic fat content.|4 months|||percentage of change from baseline||Standard Deviation|Mean
146798|NCT00413335|Secondary|Mean Percent Change From Baseline in Adiponectin|This refers to the changes of adiponectin levels.|4 months|||percentage of change from baseline||Standard Deviation|Mean
146799|NCT00413335|Primary|Percentage of Subjects Who Converted Impaired Glucose Tolerance (IGT) to Normal Glucose Tolerance (NGT)|This refers to the number of subjects that converted from IGT to NGT. NGT is defined as fasting glucose lower than 100 mg/dl and 2 hours glucose lower than 140 mg/dl. IGT is defined as 2 hours glucose higher than 140 mg/dl.|4 months|||percentage of participants|||Number
146800|NCT00413335|Primary|Mean Percent Change in Visceral-to-subcutaneous Abdominal Fat|This describes the percent changes of the ratio between visceral and subcutaneous abdominal fat.|4 months|||percentage of change from baseline||Standard Deviation|Mean
146801|NCT00413335|Primary|Mean Percent Change From Baseline in Whole-body Insulin Sensitivity|This describes the percent changes in insulin sensitivity. Insulin sensitivity was expressed as whole body insulin sensitivity index (WBISI) which is based on the values of insulin (microunits per milliliter) and glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values.The formula is: WBISI=10.000/square root of (fasting glucose x fasting insulin)x(mean glucose x mean insulin).|4 months|||percentage of change from baseline||Standard Deviation|Mean
146802|NCT00413283|Secondary|Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle|Number of participants who required a gemcitabine dose reduction on Day 8 of the first on study chemotherapy cycle.|8 days|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.||Participants|||Number
146803|NCT00413283|Secondary|Platelet Count on Day 22|Platelet count on Day 22 of the first on study chemotherapy treatment cycle (planned Day 1 of next cycle) by treatment group|Day 22|Efficacy Analysis Set, composed of all randomized participants except those who were replaced||10^9/L||Standard Deviation|Mean
146804|NCT00413283|Secondary|Number of Participants With Platelet Transfusions|Number of participants who were administered platelet transfusions during first on study treatment cycle.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.||Participants|||Number
146805|NCT00413283|Secondary|Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.|The number of participants in each treatment group with grade 3 or 4 thrombocytopenia during the first on study treatment cycle. Per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0, participants with a platelet count < 50 x 10^9/L, but ≥ 25 x 10^9/L are considered to have Grade 3 thrombocytopenia and participants with a platelet count < 25 x 10^9/L are considered to have Grade 4 thrombocytopenia. Additionally, participants with a platelet transfusion during the first on-study treatment cycle were classified as having Grade 3/4 thrombocytopenia.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced.||Participants|||Number
146806|NCT00413283|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|The duration of grade 3 or 4 thrombocytopenia (defined as platelet count <50 x 10^9/L) experienced during the first on study chemotherapy cycle by treatment group.|3 weeks|Efficacy Analysis Set, composed of all randomized participants except those who were replaced (participants who discontinued prior to the completion of at least 1 romiplostim treatment cycle for non-platelet-related reasons).||days||Standard Deviation|Mean
146807|NCT00413283|Primary|Number of Participants With Adverse Events|This summary includes all treatment-emergent adverse events recorded from the start of investigational product on this study, or any worsening of adverse events initially experienced before initiation of this study.|4 months|Safety Analysis Set, composed of all randomized participants who received at least one dose of study medication.||Participants|||Number
146808|NCT00413244|Secondary|IIEF-V: Over-all Satisfaction|Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
146809|NCT00413244|Secondary|IIEF-IV: Intercourse Satisfaction|Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
146810|NCT00413244|Secondary|IIEF -III: Sexual Desire|Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
146811|NCT00413244|Secondary|IIEF-II Orgasmic Function|Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
146812|NCT00413244|Secondary|International Index of Erectile Function (IIEF)|Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction).|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
146813|NCT00413244|Secondary|Aging Male Symptoms (AMS)|The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)|At baseline, 1 month, 3 months, and 6 months|||units on a scale||Standard Deviation|Mean
146814|NCT00413244|Secondary|Metabolic Equivalents of Task (METS)|The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg−1·min−1 or equivalently|6 months|Subjects analyzed were only those subjects with ST depression at baseline||METS units||Standard Deviation|Mean
156482|NCT00323479|Secondary|Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole|X ray assessment on hands and wrists based on 99 patients due to missing values|12 months|||millimeter||Standard Deviation|Median
146815|NCT00413244|Secondary|International Prostate Symptom Score (IPSS)|"IPSS has 7 questions related to symptoms, each item scored 1-5. Total score can range from 0 to 35 (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 (delighted to terrible.) Data not collected."|6 months||||||
146816|NCT00413244|Secondary|Reactive Hyperemia Index|The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes.|6 months|Subjects analyzed were only those subjects with ST depression at baseline||mls||Standard Deviation|Mean
146817|NCT00413244|Secondary|Seattle Angina Questionnaire (SAQ)|"A cardiac disease-related quality-of-life measure. The SAQ is a self-report instrument with 19 items that, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important.~Data not collected."|up to 6 months||||||
146818|NCT00413244|Primary|Cardiac Stress Testing: Exercise Capacity|Exercise capacity was measured using exercise time.|At 1 month, 3 months, and 6 months|Subjects analyzed were only those subjects with ST depression at baseline||seconds||Standard Deviation|Mean
146819|NCT00413244|Primary|Cardiac Stress Test: Time to ST Depression|Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.|at 6 months|Subjects analyzed were only those subjects with ST depression at baseline||seconds||Standard Deviation|Mean
146820|NCT00413231|Secondary|Percentage of Participants That Experienced Loss of Stent Graft Patency|Percentage of subjects that experienced loss of stent graft patency within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146821|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)|Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146822|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures|Percentage of subjects that experienced secondary endovascular procedures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146823|NCT00413231|Secondary|Percentage of Participants That Experienced Type IV Endoleaks|Percentage of subjects that experienced type IV endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146824|NCT00413231|Secondary|Percentage of Participants That Experienced Type III Endoleaks|Percentage of subjects that experienced type III endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146825|NCT00413231|Secondary|Percentage of Participants That Experienced Type I Endoleaks|Percentage of subjects that experienced type I endoleaks within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146826|NCT00413231|Secondary|Percentage of Participants That Experienced Conversions to Open Surgical Repair|Percentage of subjects that experienced conversions to open surgical repair within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146827|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm Ruptures|Percentage of subjects that experienced aneurysm ruptures within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146828|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related within five years post implant|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146829|NCT00413231|Secondary|Percentage of Participants That Died (All-cause Mortality)|Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants|||Number
146830|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months||Percentage of participants||95% Confidence Interval|Number
146831|NCT00413231|Secondary|Percentage of Participants That Experience Loss of Stent Graft Patency|Percentage of subjects that experience loss of stent graft patency within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging||Percentage of participants||95% Confidence Interval|Number
146832|NCT00413231|Secondary|Percentage of Participants That Experienced Stent Graft Migration|Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging||Percentage of participants||95% Confidence Interval|Number
146851|NCT00413153|Secondary|Body Composition - Visceral Adipose Tissue|6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).|6 months|Data from participants with 0 & 6 month data analyzed.||square centimeters||Standard Deviation|Mean
146833|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak|Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months|Between 30 days and 12 months|Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame)||Percentage of participants||95% Confidence Interval|Number
146834|NCT00413231|Secondary|Percentage of Participants That Experienced Endoleak(s)|Percentage of subjects that experienced endoleak(s) of any type at 12 months|At 12 months|Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks||Percentage of participants||95% Confidence Interval|Number
146835|NCT00413231|Secondary|Percentage of Participants That Experienced Conversion to Open Surgical Repair|Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects exited before 12 months||Percentage of participants||95% Confidence Interval|Number
146836|NCT00413231|Secondary|Percentage of Participants That Experience Aneurysm Rupture|Percentage of subjects that experience aneurysm rupture within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months||Percentage of participants||95% Confidence Interval|Number
146837|NCT00413231|Secondary|Percentage of Participants That Experienced Aneurysm-related Mortality|Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment|Within 12 months post treatment|Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures||Percentage of participants||95% Confidence Interval|Number
146838|NCT00413231|Secondary|Percentage of Participants That Experienced One or More Major Adverse Events|Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
146839|NCT00413231|Secondary|Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge|Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
146840|NCT00413231|Secondary|Percentage of Participants That Experienced Paraparesis|Percentage of subjects that experienced paraparesis within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
146841|NCT00413231|Primary|Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >|"The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated.~>~> Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks."|Within 12-months post treatment|Subjects treated or intended to treat with the test device||Percentage of Participants||95% Confidence Interval|Number
146842|NCT00413231|Primary|Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)|"Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b.~Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device.~Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak)."|At 12-month post procedure|Subjects treated or intended to treat with the test device||Percentage of Participants||95% Confidence Interval|Number
146843|NCT00413231|Secondary|Percentage of Participants That Experienced Paraplegia|Percentage of subjects that experienced paraplegia within 30 days post treatment|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
146844|NCT00413231|Secondary|Percentage of Participants That Experienced Perioperative Mortality|Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.|Within 30 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
146845|NCT00413231|Secondary|Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant|Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.|At implant|Subjects treated or intended to treat with the test device||Percentage of participants||95% Confidence Interval|Number
146846|NCT00413231|Primary|Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)|Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.|0 through 1825 days post treatment|Subjects treated or intended to treat with the test device||Percentage of participants||90% Confidence Interval|Number
146847|NCT00413153|Secondary|Total Bilirubin|6 month mean and standard deviation for total bilirubin.|6 months|Repeated measures analysis using all available data points for each participant||mg/dL||Standard Deviation|Mean
146848|NCT00413153|Secondary|Liver Enzymes -- Alanine Aminotransferase (ALT)|6 month mean and standard deviation for ALT.|6 months|Repeated measures analysis using all available data points for each participant||U/L||Standard Deviation|Mean
146849|NCT00413153|Secondary|Liver Enzymes -- Aspartate Aminotransferase (AST)|6 month mean and standard deviation for AST.|6 months|Repeated measures analysis using all available data points for each participant||U/L||Standard Deviation|Mean
146850|NCT00413153|Secondary|Immune Parameters -- CD4 Count|6 month mean and standard deviation for CD4+ count.|6 months|Repeated measures analysis using all available data points for each participant||cells/microL||Standard Deviation|Mean
146854|NCT00413153|Secondary|Insulin Sensitivity|6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.|6 months|Repeated measures analysis using all available data points for each participant||umol/kg/min per uU/mL insulin||Standard Deviation|Mean
146855|NCT00413153|Primary|Glucose Trafficking|"6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or trafficked to) muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity."|6 months|Only data from subjects with 0 and 6 month Positron Emission Tomography (PET) scans were analyzed.||umol/kg/min||Standard Deviation|Mean
146856|NCT00413062|Secondary|Average Number of Withdrawal Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had withdrawal bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
146857|NCT00413062|Secondary|Average Number of Breakthrough Bleeding/Spotting Days|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants who had breakthrough bleeding/spotting for the respective cycle."||days||Standard Deviation|Mean
146858|NCT00413062|Secondary|Number of Participants With an Occurrence of Continued Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the expected non-bleeding period of the next cycle.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 12 cycles|The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.||participants|||Number
146859|NCT00413062|Secondary|Number of Participants With an Occurrence of Early Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current expected bleeding period.~Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||participants|||Number
146860|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||participants|||Number
146861|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the expected non-bleeding period that was neither part of an early nor continued withdrawal bleeding.~Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||participants|||Number
151881|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Post Intervention|||units on a scale||Standard Deviation|Mean
146862|NCT00413062|Secondary|Number of Participants With an Occurrence of Absence of Withdrawal Bleeding|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the expected bleeding period. Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||participants|||Number
146863|NCT00413062|Primary|Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
146864|NCT00413062|Secondary|Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle."|Every 28-day cycle for 13 cycles (one year total)|"The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n= number of participants with evaluable cycles."||participants|||Number
146865|NCT00413062|Primary|Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)|In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.|1 year (13 cycles)|"The restricted ITT set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data)."||Pregnancies per 100 woman years|Participants|95% Confidence Interval|Number
146866|NCT00413049|Secondary|Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)|Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|||mmHg||Standard Deviation|Mean
146867|NCT00413049|Secondary|Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)|A patient achieved overall control if the msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
146868|NCT00413049|Secondary|Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)|A patient achieved diastolic control if their msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
146878|NCT00413010|Secondary|Clinical Global Impression of Severity (CGI-S) Score|CGI-S is a clinician-rated instrument measuring the severity of a subject’s symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
146869|NCT00413049|Secondary|Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)|A patient achieved a diastolic response if their msDBP < 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||Percentage of patients|||Number
146870|NCT00413049|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
146871|NCT00413049|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.|Baseline to end of study (Week 8)|Intent-to-Treat (ITT): All randomized patients who had baseline and at least one post-baseline efficacy measurement, ie, any post-baseline measurement of primary or secondary efficacy variables. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.||mmHg||Standard Error|Least Squares Mean
146872|NCT00413036|Secondary|Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.~Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.~Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.~Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.~Stable Disease(SD): Less than PR, but not progressive disease."|Up to 1459 days|Tumor Control Rate or Proportion of Participants Who Experienced Stable Disease or Better (SD+PR+CRu+CR) was not analyzed. Overall Response Rate (PR+CRu+CR) is presented as the primary endpoint, and because it is a more widely accepted/used efficacy endpoint than tumor control rate, a decision was made not to analyze tumor control rate.|||||
146873|NCT00413036|Secondary|Progression-free Survival as Determined by Central Review|"Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population||Months||95% Confidence Interval|Median
146874|NCT00413036|Secondary|Time to Progression as Determined by Central Review|"Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.~Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population||Months||95% Confidence Interval|Median
146875|NCT00413036|Secondary|Duration of Response as Determined by Central Review|"Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.~For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting."|Up to 1459 days|Intent-to-treat population||Months||95% Confidence Interval|Median
146876|NCT00413036|Primary|Participants Categorized by Best Response as Determined by Central Review|"Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.~Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.~Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.~Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.~Stable Disease(SD): Less than PR, but not progressive disease.~Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD."|Up to 1459 days|Intent-to-treat population||Participants|||Number
146877|NCT00413010|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Total Score|Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||score on scale||Standard Error|Least Squares Mean
146879|NCT00413010|Secondary|Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score|Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
146880|NCT00413010|Secondary|Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement|Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.|Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment. CI for placebo patients was not estimable.||days||95% Confidence Interval|Median
146881|NCT00413010|Secondary|Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score|Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.|Week 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
146882|NCT00413010|Secondary|Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)|Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.||participants|||Number
146883|NCT00413010|Secondary|Change in HAM-A Total Score at Weekly Visits|Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, Weeks 1 through Week 8|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.||score on scale||Standard Error|Least Squares Mean
146884|NCT00413010|Primary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks|Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.||score on scale||Standard Error|Least Squares Mean
146885|NCT00412984|Other Pre-specified|Rate of Net-Clinical Benefit During Treatment Period|Rate=number of events of net-clinical benefit per 100 patient years. Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||Number of events per 100 patient years|||Number
146886|NCT00412984|Other Pre-specified|Number of Participants With Net-Clinical Benefit During Treatment Period|Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
146887|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period|Rate=number of adjudicated TIMI bleeding events per 100 patient years. TIMI Bleeding Criteria: Major bleeding=Intracranial bleeding and/or clinically overt bleeding associated with ≥5 gm/dL fall in Hgb or 15% fall in hematocrit (Hct) from baseline, accounting for transfusions. Minor bleeding=Clinically overt bleeding associated with ≥3 gm/dL fall in Hgb or a ≥10% fall in Hct from baseline, accounting for transfusions.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.||Number of events per 100 patient years|||Number
146894|NCT00412984|Secondary|Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period||"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date, last contact date, or the efficacy cut-off date (30-Jan-2011).||Number of events per 100 patient years|||Number
146888|NCT00412984|Other Pre-specified|Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period|Rate=number of adjudicated GUSTO bleeding events per 100 patient years. GUSTO Bleeding Criteria: GUSTO severe (or life-threatening) bleeding: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. GUSTO moderate bleeding: bleeding that requires blood transfusion but does not result in hemodynamic compromise.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study. n=number of participants experiencing events.||Number of events per 100 patient years|||Number
146889|NCT00412984|Secondary|Rate of All Bleeding Events During Treatment Period|"Rate=number of all bleeding events per 100 patient years. All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death."|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||number of events per 100 patient years|||Number
146890|NCT00412984|Secondary|Number of Participants With All Bleeding Events During Treatment Period|All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
146891|NCT00412984|Secondary|Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period|Rate=number of major or CRNM bleed events per 100 patient years. Major=clinically overt and either 1) resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, or 2) led to a transfusion of 2 or more units of packed red blood cells, or 3) occurred in a critical site, or 4) led to death. CRNM bleeding=clinically overt, but satisfied no additional criteria required to be adjudicated as a major bleeding event, and led to either 1) hospital admission for bleeding or 2) physician guided medical or surgical treatment for bleeding or 3) a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||number of events / 100 patient years|||Number
146892|NCT00412984|Secondary|Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period|Major bleeding=bleeding that is clinically overt and that either resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, led to a transfusion of 2 or more units of packed red blood cells, occurred in a critical site, or led to death. CRNM bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
146893|NCT00412984|Other Pre-specified|Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period|AE: all SAEs or AEs with onset from first dose through 2 days (AEs) or 30 days (SAEs) after the last dose of blinded study drug (BSD). SAE: all SAEs with onset from first dose through 30 days after the last dose of BSD. Bleeding AE: all serious or non-serious bleeding-related AEs with onset from first dose through 2 days after the last dose of BSD. Discontinuations due to AE: all SAEs or AEs with onset from first dose of BSD and with action taken=drug discontinued. Deaths: all deaths occurring from first dose through 30 days after the last dose of BSD.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
146930|NCT00412867|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months|The number of patients with an mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months after onset|||participants|||Number
146895|NCT00412984|Secondary|Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period|For descriptions of Stroke and SE, see Outcome Measure 1. For description of Major bleeding, see Outcome Measure 3.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants who were Warfarin/Vitamin K Antagonist (VKA) naïve (a stratification variable, defined as receiving ≤30 consecutive days of prior warfarin/VKA treatment). Participants not experiencing efficacy endpoint event were censored at earlier of death, last contact, or efficacy cut-off date (30-Jan-2011).||participants|||Number
146896|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of CK-MB or Troponin T or I ≥ 2 × the ULN, or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. For description of ACD, see Outcome Measure 5.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who didn't experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n= number of participants experiencing stated combination of events.||Number of events per 100 patient years|||Number
146897|NCT00412984|Secondary|Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period|Diagnosis for an acute or evolving MI=elevation of creatine kinase-MB isoenzyme (CK-MB) or Troponin T or I ≥ 2 × the upper limit of normal (ULN), or if no CK-MB or troponin values are available, a total CK ≥ 2×ULN, or new, significant (≥0.04 s) Q waves in ≥2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date, or the efficacy cut-off date (30-Jan-2011). n=number of participants experiencing stated event.||Number of events per 100 patient years|||Number
146898|NCT00412984|Secondary|Rate of Adjudicated All-Cause Death During the Intended Treatment Period|All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, MI, sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||Number of events per 100 patient years|||Number
146899|NCT00412984|Secondary|Number of Participants With Events of All-Cause Death During the Intended Treatment Period|Death was defined as all-cause mortality. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, myocardial infarction (MI), sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||participants|||Number
146900|NCT00412984|Primary|Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period|Rate=number of adjudicated major (ISTH) bleed events per 100 patient years. ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||Number of events per 100 patient years|||Number
146931|NCT00412867|Primary|Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)|"Recanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in <50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory.~The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization."|within 6 hours, from 24 to 36 hours after onset|||participants|||Number
146901|NCT00412984|Primary|Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period|ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more over a 24-hour period and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.|"Treatment Period started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group."|Treated participants. Participants who did not experience a bleeding endpoint were censored at the earlier of 2 days after discontinuation of study drug, or death date, or last-contact date (for participants who withdrew consent to be followed up or were lost to follow-up) at the end of the study.||participants|||Number
146902|NCT00412984|Primary|Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period|Rate=Number of adjudicated stroke or SE events per 100 patient years. Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Intended Treatment Period started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||Number of events per 100 patient years|||Number
146903|NCT00412984|Primary|Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period|All suspected efficacy events were adjudicated by the Central Events Committee (CEC). Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.|"Time to first event in Intended Treatment Period: started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding)."|Intention to treat analysis, randomized participants. Participants who did not experience an efficacy endpoint event were censored at the earlier of their death date (when death is not part of the endpoint), last contact date (for subjects who withdrew consent to be followed up or were lost to follow-up) or the efficacy cut-off date (30-Jan-2011).||participants|||Number
146904|NCT00412971|Secondary|False Positive Detection Rate Patient Level||12 months|||percent of patients|||Number
146905|NCT00412971|Secondary|Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.||At day 0|ITT||percentage of participants||95% Confidence Interval|Number
146906|NCT00412971|Primary|Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.|To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.|1 year|PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients.||precentage of participants||95% Confidence Interval|Number
146907|NCT00412958|Primary|Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect|The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.|Day 7|Intent-To-Treat (ITT). Full Analysis Set.||percentage of participants|||Number
146908|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||participants|||Number
146909|NCT00412932|Secondary|Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||participants|||Number
146944|NCT00412841|Secondary|To Determine if Atorvastatin is Effective in Lowering Serum Lipid Levels Chol, TG, HDL, & LDL in SLE Patients||6 years||||||
146910|NCT00412932|Secondary|Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||participants|||Number
146911|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had baseline and week 12 ABPM measurements.||mm Hg||Standard Error|Mean
146912|NCT00412932|Secondary|Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
146913|NCT00412932|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
146914|NCT00412932|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment|All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements.|baseline to 12 weeks|178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
146915|NCT00412893|Secondary|Number of Participants With Adverse Events, Reported by System Organ Class||From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.|The safety analysis set consists of all randomized patients who received at least one dose of study drug according to the study drug that the participant actually received as the first dose. One participant was randomized to isavuconazole but received voriconazole treatment for the first 7 days and is included in the voriconazole arm for safety.||participants|||Number
146916|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the Investigator|"Radiological assessments were performed by the investigator. Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Failure is defined as a < 25% improvement at any time or results not available. Participants with no signs on radiological images at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."||percentage of participants|||Number
146917|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the Investigator|"Mycological assessments of the participant’s invasive fungal disease status were performed by the investigator using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline, or no mycological follow-up results available or indeterminate results were classified as Not Applicable.~End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."||percentage of participants|||Number
146918|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the Investigator|"Assessment of clinical symptoms and physical findings of invasive fungal disease were performed by the investigator.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening, or if results were unavailable or the participant was unevaluable. Participants with no attributable signs and symptoms present at Baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Missing data for any participant at any visit was included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."||percentage of participants|||Number
146919|NCT00412893|Secondary|Percentage of Participants With a Radiological Response Assessed by the DRC|"Independent reviews of radiology assessments were completed by radiology experts which were provided to the independent, blinded DRC. Blinded radiological assessments were performed by the DRC.~Radiological response is defined as a ≥ 50% improvement from Baseline, or improvement of at least 25% from Baseline for the Day 42 analysis or if end of treatment occurred before Day 42. Participants without any radiology at Baseline were considered Not Applicable. End of Treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. A participant with no post-baseline radiology data with evidence of radiologic disease at Baseline was considered a failure. Participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point is indicated by n."||percentage of participants|||Number
146920|NCT00412893|Secondary|Percentage of Participants With a Mycological Response Assessed by the DRC|"Blinded mycological assessments of the participant’s invasive fungal disease status were performed by the independent DRC using the results from fungal culture and isolation and/or histology/cytology of biopsy or biological fluid samples from the infected site.~Mycological response is defined as eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline. Failure was defined as persistence or presumed persistence. Participants with no mycological evidence available at Baseline were classified as Not Applicable.~End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded.||percentage of participants|||Number
146921|NCT00412893|Secondary|Percentage of Participants With a Clinical Response Assessed by the DRC|"Blinded assessments of clinical symptoms and physical findings of invasive fungal disease were performed by the independent DRC.~Clinical response is defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings. Failure is defined as no resolution of any attributable clinical symptoms and physical findings and/or worsening. Participants with no attributable signs and symptoms present at Baseline and no symptoms attributable to invasive fungal disease (IFD) developed post-baseline were classified as Not Applicable. End of treatment is the last day of study drug administration."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|"Modified intent-to-treat population. Any visits the DRC assessed as not done were considered as missing and included as a failure; participants with a Not Applicable assessment were excluded. The number of participants included in the analysis at each time point in indicated by n."||percentage of participants|||Number
146922|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator|Overall response based on investigators’ assessments was not derived as it was not deemed necessary because participants overall response status was determined by the DRC. All investigators' assessments of clinical, mycological and radiological responses are analyzed separately (see Outcome Measures 8-10).|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.||||||
146923|NCT00412893|Secondary|All-cause Mortality Through Day 84|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 84 from any cause. Participants with unknown survival status through Day 84 were included as deaths in the calculation.|Through Day 84|Intent-to-treat population||percentage of participants|||Number
146924|NCT00412893|Secondary|Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)|"The DRC was an independent, blinded committee consisting of experts in the field of infectious disease who assessed patients' outcomes. The overall response was based on the DRC-assessed clinical, mycological and radiological responses.~Success was defined as the resolution or partial resolution of all attributable clinical symptoms and physical findings, the eradication or presumed eradication of the original causative organism cultured or identified by histology/cytology at Baseline and a > 50% improvement in radiological response from Baseline (or improvement of at least 25% from Baseline for the Day 42 analysis or End of Treatment if it occurred prior to Day 42).~End of treatment (EOT) is the last day of study drug administration. For the Day 42 and Day 84 analyses, any visits that the DRC assessed as Not Done were considered a failure for that visit. A death before Day 42 was also considered a failure, even if the DRC assessed the participant to be a success prior to death."|Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.|Modified Intent-to-treat (mITT) population consisted of ITT participants who had proven or probable IFD as determined by the DRC.||percentage of participants|||Number
146925|NCT00412893|Primary|All-cause Mortality Through Day 42|All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.|Through Day 42|Intent-to-treat population||percentage of participants|||Number
146926|NCT00412867|Secondary|Safety||3 months||||||
146927|NCT00412867|Secondary|Barthel Index (BI)||the day of discharge within 3 months after onset, and 3 months after onset||||||
146928|NCT00412867|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score||within 6 hours, from 24 to 36 hours, 3 months after onset, etc.||||||
146929|NCT00412867|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours after starting treatment|||participants|||Number
146932|NCT00412854|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From receipt of first dose of study vaccine (Day 0) to study end (Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.||Subjects|||Number
146933|NCT00412854|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.||Subjects|||Number
146934|NCT00412854|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.||Subjects|||Number
146935|NCT00412854|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.||Subjects|||Number
146936|NCT00412854|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
146937|NCT00412854|Secondary|Concentrations for Anti-PRP Antibodies|Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
146938|NCT00412854|Secondary|Concentrations for Anti-D and Anti-T Antibodies|Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
146939|NCT00412854|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL|The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
146940|NCT00412854|Primary|Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies|"The vaccine response was defined as it follows:~for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination;~for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points."|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
146941|NCT00412854|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)|A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
146942|NCT00412854|Primary|Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Subjects|||Number
146943|NCT00412841|Secondary|To Determine if Atorvastatin Has an Anti-inflammatory Effect in Active SLE That Reduces Biological Markers of the Inflammatory Process (ESR, Hs-CRP) and Reduces Disease Activity Assessed by Serology (C3, C4, Anti-dsDNA) or Clinical Instrument (SLEDAI)||6 years||||||
146947|NCT00412750|Primary|Percentage of Participants With HBV DNA Non-detectability and Alanine Aminotransferase (ALT) Normalization at Week 12 and Week 24 in Participants With HBeAg-positive Chronic Hepatitis B (CHB)|The percentage of participants who achieved HBV DNA non-detectability using the COBAS Amplicor HBV Monitor assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL) and Alanine aminotransferase (ALT) normalization defined as ALT within normal limits on two successive visits for a patient with an elevated ALT (>1.0 x upper limit normal) at baseline summarized at Weeks 12 and 24.|Weeks 12 and 24|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week."||Percentage of participants|||Number
146948|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Telbivudine Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.||percentage of participants|||Number
146949|NCT00412750|Secondary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Telbivudine Monotherapy Versus Peginterferon Alpha-2a Monotherapy|Antiviral efficacy was assessed by percentage of patients achieving HBV DNA non-detectability assay utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|Week 52|The analysis was planned on intent to treat (ITT) population. Due to premature study termination, the analysis was not performed.||Percentage of participants|||Number
146950|NCT00412750|Secondary|Percentage of Participants With Hepatitis B 'e' Antigen (HBeAg) Loss and HBeAg Seroconversion|HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B ‘e’ antibody (HBeAb). The efficacy was assessed for 18 weeks, 24 weeks, 48 weeks, 52 weeks and on treatment completion (TC).|Weeks 18, 24, 48, 52 and Treatment completion (TC)|"Intent to Treat (ITT) population. The study was terminated and some participants did not complete all visits. n in each of the categories represents the number of participants in each arm with non-missing efficacy endpoint observations for the respective week and on treatment completion (TC)."||Percentage of participants|||Number
146951|NCT00412750|Secondary|Percentage of Participants Who Experienced Virologic Breakthrough at Weeks 48 and 52|The percentage of participants with Virologic breakthrough at Week 48 and 52 by treatment. For the subgroup of patients on treatment who achieve HBV DNA >= 1 log10 copies/mL reduction from baseline on 2 consecutive visits, Virologic Breakthrough is defined as HBV DNA >= 1 log10 copies/mL from nadir on two consecutive visits.|Weeks 48 and 52|Intent to treat (ITT) population. As most patients did not reach Week 48 and Week 52, the LOCF was used.||Percentage of participants|||Number
146952|NCT00412750|Secondary|Change From Baseline in HBV DNA Concentration|The change from baseline in HBV DNA concentration at Weeks 12 and 24 was analyzed using an analysis of covariance (ANCOVA) model with baseline HBV DNA concentration (log10 copies/ml) as a covariate, treatment and country as factors.|Weeks 12 and 24|Intent to Treat (ITT) population. n= the number of patients who have both baseline and post baseline observation for the respective week||log 10 copies/ml||Standard Error|Least Squares Mean
146953|NCT00412750|Primary|Percentage of Participants Who Achieved HBV DNA Non-detectability With Peginterferon Alpha-2a Plus Telbivudine Combination Therapy Versus Peginterferon Alpha-2a Monotherapy|The original primary efficacy variable was the percentage of patients achieving HBV DNA non-detectability utilizing polymerase chain reaction (PCR) (threshold for detection 300 copies/mL); however, this analysis was not performed due to premature study termination.|At week 52|The analysis was planned on intention to treat (ITT) population. Due to premature study termination, the analysis was not performed.||Percentage of participants|||Number
146954|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITTNAB Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.||participants|||Number
146955|NCT00412737|Secondary|Number of Participants With RT-PCR, or Serology/Viral Culture Confirmed Clinical Influenza, ITT Population|RT-PCR, or serology/viral culture confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR or culture within 2 days of symptoms/ last dose and/or positive serology result from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.||participants|||Number
146956|NCT00412737|Secondary|Number of Participants With RT-PCR Confirmed Clinical Influenza, ITTNAB Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population.||participants|||Number
146957|NCT00412737|Secondary|Number of Participants With Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Confirmed Clinical Influenza, ITT Population|RT-PCR confirmed clinical influenza was defined as a confirmation of influenza by positive RT-PCR result within 2 days of symptoms/last dose from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population.||participants|||Number
146958|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Intent-to-treat Virus Negative at Baseline (ITTNAB) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITTNAB population was defined as the subset of the ITT population who were culture negative at baseline.||participants|||Number
146959|NCT00412737|Secondary|Number of Participants With Laboratory Confirmed Clinical Influenza, Per Protocol (PP) Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than 37.2 °C) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum HAI titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|Per-Protocol (PP) population was defined as the subset of the ITT population who did not have any major protocol violations which would impact the assessment of efficacy.||participants|||Number
146960|NCT00412737|Primary|Number of Participants With Laboratory-Confirmed Clinical Influenza, ITT Population|Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than [>] 37.2 degrees Celsius [°C]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater increase in serum hemagglutination inhibition (HAI) titers measured from baseline to any point during the study.|From baseline up to 28 days after the last dose of study drug (maximum up to 112 days)|ITT population included all randomized participants who received at least 1 dose of study drug and had at least 1 post baseline efficacy assessment. Participants were analyzed as per initial randomization.||participants|||Number
146961|NCT00412607|Secondary|Change in Left Ventricular Ejection Fraction at 6 Month From Baseline|Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 6 month follow up. LVEF is a measure of the percentage of blood leaving heart each time it contracts. Baseline LVEF data were collected at pre ablation procedure, at hospital discharge, and at the 6-month follow-up visit.|6-month follow up|Efficacy analysis cohort subjects with LVEF data available. The statistics for Baseline and 6-month were based on data available from 219 and 166 subjects respectively; the mean change was based on 163 subjects with data at both Baseline and 6-month. Hence the mean change is not the simple subtraction between Baseline and 6-month.||percentage of blood leaving the heart||Standard Deviation|Mean
146962|NCT00412607|Secondary|Number of Subjects Achieved Long-term Efficacy Success|Long-term success is defined as patient-reported non-recurrence of Ventricular Tachycardia (VT) at the12-month, second year, and third year phone follow-ups.|3-year follow up|Subjects in the efficacy analysis cohort who completed 12-month, 2-year, or 3-year follow-up and had available long-term efficacy outcomes at the corresponding time points were included.||participants|||Number
146963|NCT00412607|Secondary|Percentage of Subjects Who Achieved Chronic Effectiveness|Chronic effectiveness is defined as subjects without recurrence of sustained monomorphic ventricular tachycardia (SMVT) at 6 month follow-up. For subjects with Implantable Cardioverter Defibrillator (ICD), recurrences of SMVT were defined as appropriate ICD shock therapies. For subjects without ICDs, recurrences of SMVT were recorded in the follow-up visits form. Besides SMVT, recurrence of incessant VT was also captured in this study. Recurrence of incessant VT was recorded up to 6 month post ablation procedure but not beyond.|6-month follow up|Subjects in the Efficacy analysis cohort who had available chronic effectiveness outcomes were included||Percentage of participants|||Number
146964|NCT00412607|Primary|The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.|The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.|Seven days post ablation procedure|Safety Analysis Cohort - defined as subjects who underwent insertion of the study catheter.||percentage of Adverse Event||95% Confidence Interval|Number
146965|NCT00412607|Secondary|Percentage of Subjects Achieved Acute Success|Acute success was defined as the subjects receiving successful ablation of all targeted Ventricular Tachycardia (VT) and no recurrence prior to hospital discharge.|Duration from post-procedure to hospital discharge, up to 2 days|Subjects in the efficacy analysis cohort who had targeted ventricular tachycardia ablated were included. Efficacy Analysis Cohort includes subjects who are enrolled and treated with the study catheter in compliance with the protocol and treated specifically for the study-related arrhythmia.||Percentage of participants|||Number
146966|NCT00412607|Primary|The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.|The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.|12-month post ablation|Safety analysis population - subjects who underwent insertion of the study catheter.||percentage of mortality||95% Confidence Interval|Number
146967|NCT00412542|Primary|Number of Participants Progression Free at 6 Months With Malignant Gliomas|Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.|6 Months|7 participants enrolled were not evaluated as they were evaluable for toxicity only (not having completed the first cycle/clinical decline/etc.).||participants|||Number
146968|NCT00412529|Secondary|Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative|PCR negative was considered <300 copies/mL. PCR positive was considered =>300 copies/mL.|At Week 12|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||Participants|||Number
146969|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production|Viral kinetic parameters were estimated with a bi-phasic mathematical model of HBV DNA by using compartments of free virus, infected cells, and uninfected target cells. The model parameter of interest was the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε). Blocking efficiency was within the range between 0 and 1.|Baseline to 12 weeks|Intent to Treat (ITT) population.||percentage of blocking efficiency||Standard Deviation|Mean
146984|NCT00412464|Primary|Number of Abnormal Lab Results Resulting in Adverse Events.|The primary outcome measure was assessment of safety by reporting the number of abnormal lab results resulting in adverse events. Safety laboratory assessments are as follows: Liver and kidney toxicity will be determined by serial measurements of AST, ALT, total bilirubin, BUN and creatinine. Hematologic toxicity will be assessed by serial CBCs.|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
146970|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:~V(t) = (1-ε)pI(t) – cV(t)~I(t) = (1- η)TV(t) – δI(t)~V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population. The value for the rate of infected cell loss for 1 patient in telbivudine arm was not used in calculation of summary statistics for this variable as this patient showed a deviation from the biphasic pattern in viral kinetic modeling.||infected cell loss per day||Standard Deviation|Mean
146971|NCT00412529|Secondary|Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance|"Viral kinetic parameters were estimated with a bi-phasic mathematical model:~V(t) = (1-ε)pI(t) – cV(t)~I(t) = (1- η)TV(t) – δI(t)~V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data."|Baseline to 12 weeks|Intent to Treat (ITT) population.||clearance per day||Standard Deviation|Mean
146972|NCT00412529|Secondary|Change in Alanine Aminotransferase (ALT) Levels||From Baseline to Week 12|Intention to treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||IU/L||Standard Deviation|Mean
146973|NCT00412529|Secondary|The Area Under the Curve (AUC) of HBV DNA Change.|In AUC efficacy analyses, all the visits from baseline to Week 12 visit (including the planned and the repeated) with a non-missing HBV DNA level were included.|From Baseline to Week 12|Intention-to-treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||(log10 copies/mL) * days||Standard Deviation|Mean
146974|NCT00412529|Secondary|Change in Mean HBV DNA Level|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.HBV DNA reductions, considered as the repeated measures, from baseline to Weeks 2, 4, 8.|Baseline (day 1) to Weeks 2, 4, 8|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||log10 copies/mL||Standard Deviation|Mean
146975|NCT00412529|Primary|Change in Mean Hepatitis B Virus (HBV) DNA Levels|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.|Baseline (day 1) to Week 12 (day 85)|Intent to Treat (ITT) population included all patients who received at least one dose of study drug and had at least one post-baseline assessment of serum HBV DNA. The randomized treatment was used in the analyses of this population.||log10 copies/mL||Standard Deviation|Mean
146976|NCT00412516|Secondary|Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|Neutralizing antibody titer determined using a 50% plaque-reduction neutralizing assay (PRNT-50) for JE virus|12, 24, 36 months post-JE vaccination|||GMT||95% Confidence Interval|Mean
146977|NCT00412516|Secondary|Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.|“Seropositive” defined as a person with neutralizing antibody against JE virus at a titer ≥ 1:10 in a 50% plaque-reduction neutralizing assay (PRNT-50)|12 months, 24 months, and 36 months post vaccination|||percentage of subjects seropositive||95% Confidence Interval|Number
146978|NCT00412516|Secondary|Measles Seropositivity at 12 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|12 months post vaccination|||percentage of subjects seropositive||95% Confidence Interval|Number
146979|NCT00412516|Primary|Measles Seropositivity at 24 and 36 Months|Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA|24, 36 months post vaccination|||percentage of participants seropositive||95% Confidence Interval|Number
146980|NCT00412464|Primary|Thrombocytopenic Events|Patient’s platelet counts should be kept above 50 x 10^9/L while on study with platelet transfusions as needed with the exception of patients enrolled under the HIT/ suspicion of HIT inclusion (platelet transfusions are contraindicated in HIT). With regards to study patients who experience progressive decreases in platelet count to below 50 x 10^9/L while receiving fondaparinux (excluding patients being treated for HIT or suspicion of HIT), fondaparinux will be discontinued.|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
146981|NCT00412464|Primary|Adverse Events|Adverse events will be defined as any untoward or unexpected event which can be a symptom, physical exam sign or laboratory abnormality. Adverse events will be classified as serious if they lead to prolonged hospitalization, re-hospitalization, transfer to an intensive care unit, or death. Adverse events will be categorized in terms of their likely association with fondaparinux as probably related, possibly related, unrelated, or unknown, and will be recorded according to standard adverse reporting guidelines for clinical trials.|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
146982|NCT00412464|Primary|Bleeding Events|Bleeding assessment Patients will be monitored for bleeding symptoms by physician and nursing assessment. Major bleeding will be defined as bleeding which is in a critical space (intracranial, retroperitoneal, or visceral) or leads to the need for blood transfusion. Minor bleeding will be all other bleeding and will be classified as clinically significant (i.e. If the physician has to take action to treat the minor bleed) or clinically insignificant (i.e. if the physician does not need to intervene to treat the minor bleed).|Study period which was up to 21 days of fondaparinux|||Adverse Events|||Number
146983|NCT00412464|Primary|Therapeutic Plasma Concentration of Fondaparinux at 21 Days|Subjects all had detailed pharmacokinetic measurements done which were subsequently analyzed in a population pharmacokinetic model. This model then informed the dosing recommendations that were published as a result of the study.|21 days|||mg/dL||Standard Deviation|Mean
146985|NCT00412451|Primary|PVD Induction|The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)|Day 14 post-injection|Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF)||percentage of participants|||Number
146986|NCT00412425|Primary|Cumulative Participants Response to Palonosetron|Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.|7 days|Analysis was per protocol.||episodes of nausea/vomiting|||Number
146987|NCT00412373|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146988|NCT00412373|Other Pre-specified|Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146989|NCT00412373|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146990|NCT00412373|Other Pre-specified|Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146991|NCT00412373|Secondary|Participants With Response|Response is defined as a 30% or more reduction from baseline PANSS total score and CGI-C score of <= 2 (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder).|Week 6 LOCF End Point|Intent-to-Treat||participants|||Number
146992|NCT00412373|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|"The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to No change. Ratings of <4 are equivalent to improvement and ratings of > 4 are equivalent to worsening. Higher scores indicate worsening."|Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146993|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146994|NCT00412373|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill subjects. Higher scores indicate worsening."|Baseline|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146995|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146996|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
147014|NCT00412360|Secondary|Neutrophil Engraftment|Neutrophil engraftment is defined as achieving an ANC ≥ 500/mm3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment.|Day 180|||percentage of participants||95% Confidence Interval|Number
147015|NCT00412360|Secondary|Disease-free Survival|Disease-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.|Year 1|||percentage of participants||95% Confidence Interval|Number
146997|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146998|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
146999|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
147000|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
147001|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
147002|NCT00412373|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment|Intent-to-Treat||points on a scale||Standard Deviation|Mean
147003|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.||points on a scale||Standard Deviation|Mean
147004|NCT00412373|Primary|Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.||points on a scale||Standard Deviation|Mean
147005|NCT00412360|Secondary|Immune Reconstitution||100 days, 6 months, 1 and 2 years||||||
147006|NCT00412360|Secondary|Chimerism||28, 42, 60, 180, 365 days||||||
147007|NCT00412360|Secondary|Engraftment Syndrome||Day 100|||participants|||Number
147008|NCT00412360|Secondary|Platelet Engraftment|Platelet engraftment to 50,000/mL|Day 180|||percentage of participants||95% Confidence Interval|Number
147009|NCT00412360|Secondary|Relapse|Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features.|Year 1|||percentage of participants||95% Confidence Interval|Number
147010|NCT00412360|Secondary|Infections||Year 2|||participants|Participants||Number
147011|NCT00412360|Secondary|Treatment-related Mortality||Year 1|||percentage of participants||95% Confidence Interval|Number
147012|NCT00412360|Secondary|Chronic GVHD|Incidences of chronic GVHD will be scored according to the BMT CTN MOP.|Year 1|||percentage of participants||95% Confidence Interval|Number
147013|NCT00412360|Secondary|Acute Graft-versus-host Disease (GVHD)|Incidences of grade II – IV and III – IV acute GVHD at Day 100 will be graded according to the BMT CTN Manual of Procedures (MOP).|Day 100|||participants|||Number
147017|NCT00412243|Primary|Maximum Tolerated Dose for Cyclophosphamide (MTD)|MTD is dose at which there are no dose limiting toxicity (DLT) defined as any =/> grade 3 drug-related non-hematologic toxicity that occurs within the first 14 days after start of treatment. Evaluation using continual reassessment method; 3-5 Day Cycle|First 14 days of each cycle|MTD calculated with first 8 study participants.||mg/m^2|||Number
147018|NCT00412217|Secondary|Overall Survival (OS)|OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.||months||95% Confidence Interval|Median
147019|NCT00412217|Secondary|Number of Participants Who Died|The number of participants who died from any cause was reported.|From inclusion in the study until death from any cause (maximum up to 3 years overall)|ITT Population.||participants|||Number
147020|NCT00412217|Primary|Time to Progression (TTP)|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.|From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)|ITT Population.||months||95% Confidence Interval|Median
147021|NCT00412217|Primary|Number of Participants With Disease Progression|Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.|From inclusion in the study until disease progression (maximum up to 3 years overall)|ITT Population.||participants|||Number
147022|NCT00412113|Primary|Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk|Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.|Week 6, baseline|The full analysis set of all randomized subjects who took at least one dose of study drug and had any post-baseline efficacy assessment||score on scale||Standard Deviation|Least Squares Mean
147023|NCT00412113|Secondary|Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.|Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||score on scale||Standard Deviation|Least Squares Mean
147024|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) at Week 6.|Mean change at observation minus mean baseline.|Week 6 , baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
147025|NCT00412113|Secondary|Change From Baseline in Total Cholesterol (TC) to Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mg/dL||Standard Deviation|Mean
147026|NCT00412113|Secondary|Change From Baseline in HDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
147027|NCT00412113|Secondary|Change From Baseline in LDL at Week 6.|Mean change at observation minus baseline.|Week 6, baseline|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
147028|NCT00412113|Secondary|Change From Baseline in Triglycerides (TG) to Week 4.|Mean change at observation minus baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
147029|NCT00412113|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mg/dL||Standard Deviation|Mean
147030|NCT00412113|Secondary|Change From Baseline in High Density Lipoprotein (HDL) at Week 4.|Mean change at observation minus baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mg/dL||Standard Deviation|Mean
147031|NCT00412113|Secondary|Change From Baseline in LDL at Week 4.|Change: mean of observation minus mean at baseline.|Week 4, baseline|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||mg/dL||Standard Deviation|Mean
147032|NCT00412113|Secondary|Change From Baseline to Week 6 in Pulse Rate|Mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||bpm||Standard Deviation|Mean
147033|NCT00412113|Secondary|Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)|Change from mean at observation minus mean at baseline|Week 6, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mmHg||Standard Deviation|Median
147035|NCT00412113|Secondary|Change From Baseline to Week 4 in Pulse Rate|Mean at observation minus mean at baseline measured in beats per minute (bpm).|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||bpm||Standard Deviation|Mean
147036|NCT00412113|Secondary|Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mmHg||Standard Deviation|Mean
147037|NCT00412113|Secondary|Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).|Mean at observation minus mean at baseline|Week 4, baseline|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||mmHg||Standard Deviation|Mean
147038|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 6|Subjects achieving BP goal of <140/90 mmHg at week 6|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||participants|||Number
147039|NCT00412113|Secondary|Subjects With BP < 140/90 mmHg at Week 4|Subjects achieving BP goal of <140/90 mmHg at week 4|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS||participants|||Number
147040|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 6|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.|Week 6|Full analysis set (FAS) All randomized subjects who take at least one dose of study drug and have any post-baseline efficacy assessments.||participants|||Number
147041|NCT00412113|Secondary|Subjects With LDL-C < 100 mg/dL at Week 4|Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||participants|||Number
147042|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6.|Week 6|Full analysis set (FAS).||participants|||Number
147043|NCT00412113|Secondary|Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.|Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4.|Week 4|Full analysis set (FAS). All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||participants|||Number
147044|NCT00412113|Secondary|Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4|Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.|Week 4|Full analysis set. All randomized subjects who took study drug and had at least one post-baseline efficacy assessment comprised the FAS.||participants|||Number
147045|NCT00412113|Primary|Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6|Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)|Week 6|Full analysis set (FAS) is all randomized subjects who take at least one dose of study drug and and have any post-baseline efficacy assessments.||participants|||Number
147046|NCT00412087|Secondary|Parathyroid Hormone at Visit 7|Intact parathyroid hormone at Visit 7, one month prior to delivery|7 months|There was 1 subject in the 2000 IU group and 3 subjects in the 4000 IU group missing PTH measurements.||pg/mL||Standard Deviation|Mean
147047|NCT00412087|Primary|25-hydroxyvitamin D at Visit 7|25-hydroxyvitamin D at Visit 7, one month prior to delivery|7 months|||ng/mL||Standard Deviation|Mean
147048|NCT00412074|Secondary|Infant Health Status - Vitamin D Deficiency|Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months of age|The number of infants analyzed in each group was fewer than the number of subjects analyzed for the maternal outcomes - though blood draws were attempted for all infants at Visit 7, we were unable to obtain blood from 14 infants in the 400 IU arm, 7 infants in the 2400 IU arm, and 14 infants in the 6400 IU arm.||percentage|||Number
147049|NCT00412074|Secondary|Maternal Health Status - Vitamin D Deficiency|Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7|to 7 months postpartum|||percentage|||Number
147050|NCT00412074|Primary|25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery||to 7 months postpartum|||ng/mL||Standard Deviation|Mean
147051|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)|"Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be ‘Elevated’; otherwise considered as Non-elevated."|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.||Months||95% Confidence Interval|Median
147052|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.||Patients|||Number
147105|NCT00411411|Primary|the Relative Increase in Meal-induced Total GLP-1 Secretion|Patients will be followed for 12 weeks with three meal test examinations; before treatment, after 1 week of treatment and after 12 weeks of treatment. Primary outcome is AUC GLP-1 (pM x 120 as stated).|12 weeks|||pM x 120 min||Standard Deviation|Mean
147053|NCT00412061|Secondary|Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From first day of treatment up to 28 days after last day of treatment in double blind|The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.||Patients|||Number
147054|NCT00412061|Secondary|Overall Survival Using Kaplan-Meier Methodology|Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.|Months 12, 24, 36, 48|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.||Percentage of Participants||95% Confidence Interval|Number
147055|NCT00412061|Secondary|Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level|5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as ‘High’ if they exceeded the median value, and ‘Low’ if they were lower than or equal to the median.|If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.||Months||95% Confidence Interval|Median
147056|NCT00412061|Secondary|Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)|The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.||Percentage of patients||95% Confidence Interval|Number
147057|NCT00412061|Primary|Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review|Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.|Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010|The Full Analysis Set (FAS) consisted of all randomized patients.||Months||95% Confidence Interval|Median
147058|NCT00411788|Secondary|To Evaluate the Use of FDG-PET as an Early Predictor of Response to the Combination of Rapamycin and Trastuzumab, be Assessing Changes in Glucose Metabolism and Cell Viability Between Pre- and Post-treatment||Upon completion of study|This outcome measure was not collected nor analyzed due to study closure and low sample size.|||||
147059|NCT00411788|Secondary|To Determine if Currently Available RNA Expression Profiles Associated With Response to Herceptin Will be Predictably Altered in Tumors Treated With Trastuzumab and Rapamycin, and Will Further Elucidate the Mechanism of Synergy of These Two Agents||study completion|This outcome measure was not collected nor analyzed due to study closure and low sample size.|||||
147060|NCT00411788|Secondary|To Determine Pre and Post Therapy Changes in the Levels, Phosphorylation Status and/or Subcellular Localization of the Affected Signal Transduction Molecules HER2, Akt, S6K and 4EBP1 in Blood and Tumor Tissues|These data were not collected and analyzed as described here in the initial protocol submission.|Upon completion of study||||||
147061|NCT00411788|Secondary|Incidence of Cardiac Dysfunction|"This safety measure was used to determine the number of patients treated with the combination of trastuzumab and rapamycin with cardiac dysfunction.~This secondary outcome measure was reworded from its original version when results were entered."|study completion up to 58 weeks|Safety population consisting of 9 of 11 patients that received treatment following first dose.||participants|||Number
147062|NCT00411788|Secondary|Objective Response Rate (ORR)|"ORR was determined according to RECIST criteria, duration of response, and time to progression in patients with HER2 overexpressing advanced breast cancer receiving trastuzumab and rapamycin. The objective response rate (ORR) by response evaluation criteria (RECIST) 1.0, duration of response, safety, and pharmacodynamic endpoints.~This secondary outcome measure was reworded from its original submission when results were entered."|study completion up to 58 weeks|||participants|||Number
147063|NCT00411788|Primary|Proportion of Patients Who Are Progression-free (CR, PR and Stable Disease)|"To determine the clinical activity of oral daily rapamycin administered in combination with weekly intravenous trastuzumab in patients with HER2 overexpressing advanced breast cancer, the primary outcome is to determine the proportion of patients who are progression-free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD).who are progression free at 16 weeks, defined by complete response (CR), partial response (PR), or stable disease (SD). Response objectives assessed using response evaluation criteria (RECIST) 1.0~This primary outcome was reworded from its original format when results were entered."|16 weeks|Nine patients were evaluable for response assessment. Two patients withdrew from study before first response assessment (one for noncompliance and the other for toxicity).||participants|||Number
147064|NCT00411762|Secondary|Median Overall Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response||weeks||Full Range|Median
147106|NCT00411398|Primary|Hamilton Anxiety Scale|Standard Clinical Depression Rating Scale. Clinician administered. Scale units are points/numbers. Possible range is 0 to 44 with the latter signifying more severe anxiety|10 wk|LOCF if at least one post baseline visit completed||units on a scale||Standard Deviation|Mean
147065|NCT00411762|Primary|Median Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 100 weeks|20 subjects received 2 cycles or more and were evaluated for response||weeks||Full Range|Median
147066|NCT00411749|Secondary|HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series|Month 30 HPV cLIA Geometric Mean Titers by vaccine group.|24 month after completed vaccination series (Month 30)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
147067|NCT00411749|Primary|Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
147068|NCT00411749|Primary|Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
147069|NCT00411749|Primary|Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
147070|NCT00411749|Primary|Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group.~The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.||Geometric Mean Titers (mMU/mL)||95% Confidence Interval|Geometric Mean
147071|NCT00411671|Secondary|Tumor Response Measured Every 8-weeks|Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|At baseline and then every 8 weeks until treatment discontinuation.|Of the enrolled participants, only 98 were evaluable for the outcome.||participants|||Number
147072|NCT00411671|Secondary|Progression-Free Survival|The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.|From date of randomization until PD or death respectively, up to 3 years|Of the enrolled participants, only 98 were evaluable for the outcome.||months||Full Range|Median
147073|NCT00411671|Primary|8-Week Disease Control Rate|The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 8 weeks|Of the enrolled participants, 98 were evaluable for the outcome.||percentage of participants|||Number
147074|NCT00411645|Secondary|Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of VP 44469, a metabolite of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The PK population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
147095|NCT00411450|Primary|Overall Survival|Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
158186|NCT00307489|Secondary|HBsAg Loss at Week 48|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure||participants|||Number
147075|NCT00411645|Secondary|Plasma Concentration of Maribavir During Treatment|Pharmacokinetic (PK) profile sampling was performed to evaluate plasma concentrations of Maribavir. During the study drug administration period, blood samples for this purpose were collected on Day 7 (Week 1) and at Week 4. Every effort was made to ensure that doses were administered 12 hours apart on the day before and on the day of PK sampling. Permissible assessment windows for PK profile sampling purposes were +/- 3 days and +/- 5 days for the 1- and 4- week samples, respectively. Samples were analyzed by a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) method. The validated lower limit of quantitation (LLOQ) in plasma was 0.2 μg/mL.|12 hours post-dose after 1 and 4 weeks of treatment|The pharmacokinetic (PK) population, defined as those participants in the ITT population from whom plasma samples were drawn, tested for maribavir concentrations, and complete, evaluable PK data were available.||μg/mL||Standard Deviation|Mean
147076|NCT00411645|Secondary|Number of Participants Who Died Within 12 Months Post-Transplantation||Through 12 months post-transplant (Days 1 to 100, 6 months, and 12 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.||participants|||Number
147077|NCT00411645|Secondary|Percent of Participants With Chronic Graft-Versus-Host Disease (GVHD)|Analysis of chronic GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for chronic GVHD. The percentage reported is for the occurrence of any grade of chronic GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT-S population, defined as participants in the ITT population who received at least one dose of study drug.||percentage of participants|||Number
147078|NCT00411645|Secondary|Percent of Participants With Acute Graft-Versus-Host Disease (GVHD)|Analysis of acute GVHD was based on reported adverse events that mapped to the relevant MedDRA dictionary terms for acute GVHD. The percentage reported is for the occurrence of any grade of acute GVHD.|Through 6 months post-transplant (Days 1 to 100 and 6 months post-transplant)|The ITT Safety (ITT-S) population, defined as participants in the ITT population who received at least one dose of study drug.||percentage of participants|||Number
147079|NCT00411645|Secondary|Number of Participants With EC-confirmed CMV Disease Within 12 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|12 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
147080|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|100 days post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
147081|NCT00411645|Secondary|Number of Participants With Investigator-determined CMV Disease|CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|Through 12 months post-transplant (Day 1 to 100 days, 6 months, and 12 months post-transplant)|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
147082|NCT00411645|Secondary|Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post- Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease) were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay or (2) CMV DNA polymerase chain reaction (PCR). CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||days||Inter-Quartile Range|Median
147083|NCT00411645|Secondary|Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-transplant|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The ITT population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
147084|NCT00411645|Primary|Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation|All investigator-determined cases of CMV disease (i.e., CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. CMV infection was assessed by (1) pp65 antigenemia assay; (2) CMV DNA polymerase chain reaction (PCR); (3) either assay (pp65 antigenemia or CMV DNA PCR); or (4) initiation of anti-CMV therapy. CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA PCR assay in plasma) and fever >/=38 °C on >/=2 occasions >/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell [WBC] count <3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was >4000/mm3) >/=24 hours apart, atypical lymphocytosis >/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.|6 months post-transplant|The Intent-to-Treat (ITT) population, defined as all participants who were randomized to one of the therapy groups, regardless of whether the participant received study drug or had any post-baseline evaluations.||participants|||Number
147085|NCT00411619|Secondary|Overall Reduction in SEGA Tumor Volume.||During the entire study|||participants|||Number
147086|NCT00411619|Primary|Number With Observed Adverse Side Effects||During the entire study|||participants|||Number
147087|NCT00411554|Secondary|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
147088|NCT00411554|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.||mg/dL||95% Confidence Interval|Least Squares Mean
147089|NCT00411554|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations.||Percent||95% Confidence Interval|Least Squares Mean
147090|NCT00411450|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies). When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.|Prior to first dose and 28 days after the last dose of second-line treatment|Safety Analysis Set with baseline anti-panitumumab antibody testing sample available||participants|||Number
147091|NCT00411450|Secondary|Number of Participants With Grade 4 Laboratory Toxicities|Laboratory toxicities were graded according to CTCAE version 3.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety Analysis Set||participants|||Number
147092|NCT00411450|Primary|Time to Response|Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders in the Tumor Response Analysis Set||weeks||Full Range|Median
147093|NCT00411450|Primary|Time to Progression|Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
147094|NCT00411450|Primary|Time to Treatment Failure|Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
149550|NCT00391989|Primary|Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).||End of the study, up to day 85|||Patients|||Number
147096|NCT00411450|Primary|Duration of Response|Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Responders of Tumor Response Analysis Set||weeks||95% Confidence Interval|Median
147097|NCT00411450|Primary|Disease Control Rate at Weeks 17 and 25|The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.|Week 17 and Week 25|Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
147098|NCT00411450|Primary|Progression-free Survival Time|Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.|From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.|Primary Analysis Set||weeks||95% Confidence Interval|Median
147099|NCT00411450|Primary|Progression-free Survival Rate at Weeks 17 and 25|"The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria.~PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment."|Week 17 and Week 25|Primary Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, and who had valid KRAS mutation status data available)||percent probability||95% Confidence Interval|Number
147100|NCT00411450|Primary|Best Response During Second-Line Treatment|"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders.~CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions."|Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.|Tumor Response Analysis Set||percentage of participants||95% Confidence Interval|Number
147101|NCT00411450|Secondary|Number of Participants With Adverse Events|The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator. A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.|From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.|Safety analysis set (all participants who provided informed consent prior to the initiation of any study specific procedure and who received at least 1 dose of panitumumab)||participants|||Number
147102|NCT00411450|Primary|Objective Response Rate at Weeks 17 and 25|Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|Week 17 and Week 25|Tumor Response Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, who had valid KRAS mutation status data available and with at least 1 uni-dimensionally measurable lesion per the local investigator)||percentage of participants||95% Confidence Interval|Number
147103|NCT00411411|Secondary|Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)|Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose). Patients will be followed for 12 weeks with three examinations; before, during and after the treatment|12 weeks||||||
147104|NCT00411411|Primary|Restoration of the Insulinotropic Effect of GIP|Restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose. Patients will be followed for 12 weeks with examinations after 1 and after 12 weeks of treatment.|12 weeks|||pM x 120 min||Standard Error|Mean
147107|NCT00411216|Secondary|Eye Movements: Scleral Search Coil|eye movements are measured by having the participant sit within an electromagnetic field while wearing a scleral coil (like a contact lens but only in contact with the sclea, not the cornea); te coil moves with eye movement and distorts the electrimagnetic field|pre- and post-treatment||||||
147108|NCT00411216|Secondary|Fall Risk (Dynamic Gait Index)|performance test|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
147109|NCT00411216|Secondary|Balance and Gait|gait speed|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
147110|NCT00411216|Secondary|Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium|visual analoque scales|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
147111|NCT00411216|Secondary|Activities Specific Balance Confidence Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
147112|NCT00411216|Secondary|Disability Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
147113|NCT00411216|Primary|Subjective Complaints: (All Pre- and Post-intervention):|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge||||||
147114|NCT00411216|Primary|Change in Visual Acuity During Head Movement From Baseline to Discharge|"visual acuity is measured using a computerized system first with the head stationary and then with the head moving in yaw plane. Head velocity is measured using a rate sensor and optotype is displayed only when head velocity is between 120 and 180 degrees per second.~The change in visual acuity was calculated from subtracting the discharge measurement from the baseline measurement (pre-intervention)."|pre-intervention and at discharge|||LogMAR||Standard Deviation|Mean
147115|NCT00411151|Secondary|Safety and Tolerability: Adverse Events in ≥10% of Patients||one year|Safety population comprises all patients registered.||Participants|||Number
147116|NCT00411151|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|one year|Safety population comprises all patients registered.||Participants|||Number
147117|NCT00411151|Secondary|Adverse Events|The number of participants with at least one adverse event was measured.|one year|Safety population comprises all patients registered.||Participants|||Number
147118|NCT00411151|Secondary|One-Year Survival|One-year survival is defined as the percentage of participants surviving for at least one year after first dose of trial medication.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Participants (%)||95% Confidence Interval|Number
147119|NCT00411151|Secondary|Overall Survival (OS)|OS is defined as the time from the first dose of trial medication to date of death due to any cause.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Days||95% Confidence Interval|Median
147120|NCT00411151|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from first dose of trial medication to first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Days||95% Confidence Interval|Median
147121|NCT00411151|Primary|Objective Response Rate (ORR)|The primary endpoint is the ORR within the first 6 treatment cycles, defined as the percentage of participants with a confirmed reduction in tumor size fulfilling the criteria for complete or partial response (CR or PR) according to RECIST. CR=disappearance of all target lesions, PR=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions|one year|Intention-to-treat (ITT) population comprises all patients registered, except one patient whose tumor diagnosis was not confirmed.||Participants (%)||95% Confidence Interval|Number
147122|NCT00410904|Secondary|Overall Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.|The time from start of treatment to time of death, assessed up to 4 years||||||
147123|NCT00410904|Secondary|Progression-free Survival|Estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.|The duration of time from start of treatment to time of progression, assessed up to 4 years||||||
147124|NCT00410904|Primary|Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT:~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)"|Up to 4 years|||participants|||Number
147125|NCT00410891|Primary|Positive Culture||2|||percentage of patients|||Number
147126|NCT00410891|Primary|Conjunctival Bacterial Flora|number of bacteria on the conjunctiva|3 days||||||
147127|NCT00410826|Secondary|Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 3 months for up to 5 years|||participants|||Number
147128|NCT00410826|Secondary|Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm||30 days after the completion of therapy||||||
147129|NCT00410826|Primary|Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm|Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).|12 weeks after the completion of therapy|||percentage of participants|||Number
147156|NCT00410488|Primary|Palonosetron Response Rate in the 10 Day Study Cycle|Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.|10 days|||percentage of participants|||Number
147130|NCT00410761|Secondary|Time to Worsening of Pain (TWP)|TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.|During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.|||Weeks|||Number
147131|NCT00410761|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.|Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up|||Participants|||Number
147132|NCT00410761|Secondary|Biochemical Response Calcitonin (CTN)|Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.|Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up|||Participants|||Number
147133|NCT00410761|Secondary|Overall Survival (OS)|As data was immature at data cut off, number of death events is quoted|Number of deaths since randomisation|||Participants|||Number
147134|NCT00410761|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment). Values are estimated as the medians weren't met|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent|DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median||Months||95% Confidence Interval|Median
147135|NCT00410761|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent|||Participants|||Number
147136|NCT00410761|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.|||Participants|||Number
147137|NCT00410761|Primary|Progression-Free Survival(PFS)|Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.|RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.|||Months||95% Confidence Interval|Median
147138|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score|"Participants were asked to rate how much their urinary symptoms interfered overall with their everyday life on a scale from 0 (not at all) to 10 (a great deal).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147139|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score|"Quality of life was assessed by the ICIQ-LUTSqol questionnaire which consists of 19 questions each on a 1-4 scale (larger scores correspond to less quality of life). The total symptom score ranges from 19 - 76.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147140|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score|"The degree to which urinary symptoms bothered participants was assessed by the ICIQ MaleLUTS questionnaire which consists of 13 symptom bother questions each on a 0-10 scale (larger scores correspond to worse outcomes). The total bother score ranges from 0 to 130.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147141|NCT00410514|Secondary|Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score|"Male lower urinary tract symptoms were assessed by the ICIQ MaleLUTS questionnaire which consists of 13 questions each on a 0-4 scale (larger scores correspond to worse conditions). The total symptom score ranges from 0 to 52.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147142|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition|"The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||mL||Standard Error|Least Squares Mean
147143|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|"The mean number of incontinence episodes (the involuntary leakage of urine) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. The analysis only includes patients with >0 incontinence episodes at baseline. End of treatment (EOT) includes patients who didn't complete Week 12.||Incontinence episodes||Standard Error|Least Squares Mean
147144|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours|"For each micturition and/or incontinence episode in the 3 days preceding the clinic visit, participants rated the degree of associated urgency (the sudden compelling desire to pass urine, which is difficult to defer) according to the following scale: 0: No Urgency, felt no need to empty my bladder but did so for another reason; 1: Mild Urgency, could postpone passing water for as long as necessary; 2: Moderate Urgency, could postpone passing water for a short while; 3: Severe Urgency, could not postpone passing water; 4: Urge Incontinence, leaked before reaching the toilet.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||Urgency episodes||Standard Error|Least Squares Mean
147145|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours|"A micturition is any voluntary urination, excluding episodes of incontinence only. The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||micturitions||Standard Error|Least Squares Mean
147146|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)|"The patient perception of bladder condition (PPBC) asks participants to assess their bladder condition using a 6-point validated Likert scale which ranges from 1 (does not cause me any problems at all) to 6 (causes me many severe problems).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147147|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 questions relating to storage symptoms (frequency, urgency and nocturia) and ranges from 0 to 15 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147249|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147148|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 questions relating to urination (incomplete emptying, intermittency, weak stream and straining) and ranges from 0 to 20 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147149|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score|"The IPSS is a validated global questionnaire used to assess the degree of “bother” from benign prostatic hyperplasia symptoms and is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at baseline & 1 or both at any postbaseline on-treatment visit. End of treatment (EOT) includes the last on-treatment assessment for patients who didn't complete Week 12; N is the number of patients included.||scores on a scale||Standard Error|Least Squares Mean
147150|NCT00410514|Secondary|Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests|Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).|The Safety Analysis set included all participants who received at least one dose of study drug.||participants|||Number
147151|NCT00410514|Secondary|Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)|"Healthy micturitions (urinations) result in complete emptying of the bladder. Post Void Residual (PVR) is the volume of urine retained after voiding and was assessed using abdominal ultrasound. An increasing PVR over time is an indicator of abnormal bladder function or detrusor decompensation.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Weeks 1, 4, 8 and 12|The Safety Analysis set included all participants who received at least one dose of study drug. End of treatment (EOT) analysis includes the last assessment for patients who did not complete the Week 12 visit; N indicates the number of patients included at each time point.||mL||Standard Error|Least Squares Mean
147152|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)|"Bladder Voiding Efficiency (BVE) is a product of bladder contractility against the urethral resistance and is measured according to the degree of bladder emptying. BVE is expressed as a percentage and is calculated using the formula:~Bladder Voiding efficiency = (Voided volume x 100)/maximum cystometric capacity.~A higher number indicates a higher voiding efficiency. Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||Percent voiding efficiency||Standard Error|Least Squares Mean
147153|NCT00410514|Primary|Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)|"Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||cmH2O||Standard Error|Least Squares Mean
147154|NCT00410514|Secondary|Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)|"The Bladder Contractile Index (BCI) is a value used to measure the degree of contractility. BCI was calculated using the following formula:~BCI = pdetQmax + 5Qmax.~Strong contractility is a BCI > 150, normal contractility is a BCI of 100-150 and weak contractility is a BCI of < 100.~Least squares means were derived from an ANCOVA model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||Scores on a scale||Standard Error|Least Squares Mean
147155|NCT00410514|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|"Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.~Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate."|Baseline and Week 12|The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug & had both Qmax & PdetQmax measurements at Baseline & 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.||mL/sec||Standard Error|Least Squares Mean
147157|NCT00410410|Secondary|OL; Number of Participants Using Corticosteroids During OL|Participants taking oral corticosteroids (equivalent of ≤ 30 mg prednisone daily) must have met minimum treatment duration at entry into IP and had stable dose for ≥2 weeks prior to entry into the IP.|Day OL-1 through Day OL-729|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of corticosteroid use was not conducted for the OL as planned.|||||
147158|NCT00410410|Secondary|OL; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."||participants|||Number
147159|NCT00410410|Secondary|OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Clinical remission = Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Change from Baseline= post-Baseline - Baseline value.|Last Study Visit (Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical efficacy upon retreatment with abatacept among participants who received study drug during the IP or MP was not conducted for the OL as planned.|||||
147160|NCT00410410|Secondary|OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) During OL|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Open-Label Period (Day OL-1 through Day OL-729)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing was not conducted for the OL as planned.||participants|||Number
147161|NCT00410410|Primary|OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147162|NCT00410410|Primary|OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147163|NCT00410410|Primary|OL; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day OL-1 through Day OL-729|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147164|NCT00410410|Secondary|OL; Number of Participants With Clinical Remission Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.||participants|||Number
147165|NCT00410410|Secondary|OL; Number of Participants With Clinical Response Over Time|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the efficacy analyses of the OL. Number of Participants Analyzed=all participants in OL; n=number of evaluable participants.||participants|||Number
149593|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population||12 cycles, 28 days each (336 days)|MITT Population||Days||Standard Deviation|Median
147166|NCT00410410|Primary|OL; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day OL-1 through Day OL-729|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.|||||
147167|NCT00410410|Secondary|MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147168|NCT00410410|Secondary|MP; Number of Participants With Marked Hematology Laboratory Abnormalities|High=greater than ULN, Low=lower than LLN. LLN/ULN= HGB: >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; PLT: <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; GGT: >2 x ULN; Bilirubin: >2 x ULN; BUN: >2 x BL; Na: <0.95 x LLN/ >1.05 x ULN; K: <0.9 x LLN/ >1.1 x ULN; Ca: <0.8 x LLN/>1.2 x ULN|Day IP-85 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147169|NCT00410410|Secondary|MP; Number of Participants With Physical Examination Findings|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-85 through Day MP-365|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.|||||
147170|NCT00410410|Secondary|MP; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147171|NCT00410410|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day MP-1 through Day MP-365|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147172|NCT00410410|Secondary|MP; Number of Participants With Abatacept-Induced Antibodies|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements starting after Day MP-1 (including follow-up visits). For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1).|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."||participants|||Number
147173|NCT00410410|Secondary|MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of mucosal healing in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||||
147543|NCT00408681|Secondary|Mucosal Anatomic Recovery|Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response.|2 to 3 weeks after starting treatment with the study product|||Participants|||Count of Participants
147174|NCT00410410|Secondary|MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance =inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical remission in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||||
147175|NCT00410410|Secondary|MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary subgroup analyses of clinical response in subjects who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.|||||
147176|NCT00410410|Secondary|MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with PGA subscores indicating mild disease (≤1) was not conducted for the MP as planned.|||||
147177|NCT00410410|Secondary|MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with stool frequency subscores indicating mild disease (≤1) was not conducted for the MP as planned.|||||
147178|NCT00410410|Secondary|MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants with rectal subscores indicating mild disease (≤1) was not conducted for the MP as planned.|||||
147179|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.|||||
147180|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36)|The SF-36 is a validated instrument to measure health-related quality of life across multiple disease states. Individual subscale scores and 2 summary scores are calculated: (1) physical component summary (PCS) which includes physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS) which includes vitality, social functioning, role-emotional, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight, with values ranging from worse health (0) to best health (100).|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.|||||
147181|NCT00410410|Secondary|MP; Mean Change From Baseline to Month 12 in IBDQ|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Day MP-365|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.|||||
147544|NCT00408681|Secondary|Duration of Treatment With the Study Product||Up to 6 months|||days||Full Range|Median
149594|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Days||Standard Deviation|Median
147182|NCT00410410|Secondary|MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12|Baseline corticosteroids equivalent of ≤30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Day MP-365 (Month 12)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.|||||
147183|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 6 (Day MP-169), Month 12 (Day MP-365)|Due to the early termination of the study after preliminary IP1C results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis to determine the percentage of participants in clinical remission at both Month 6 and Month 12 was not conducted for the MP as planned.|||||
147184|NCT00410410|Secondary|MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147185|NCT00410410|Secondary|MP; Number of Participants in Clinical Remission at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147186|NCT00410410|Secondary|IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|"All subjects with at least one post-baseline immunogenicity measurement during the study period were included in the immunogenicity data set. Positive was defined as positive post-baseline IP-1 and with a titer value greater than the baseline titer value. Participants with missing baseline titer were assumed negative at baseline."||participants|||Number
147187|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147188|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN;|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147189|NCT00410410|Secondary|IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use ≥2 when BL value missing or value ≥4, or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147190|NCT00410410|Secondary|IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147191|NCT00410410|Secondary|IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147192|NCT00410410|Secondary|IP; Number of Participants With Physical Examination Findings: IP1C + IP2C|Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).|Day IP-1 through Day IP-85|As the results of this study were presented in a synoptic report, physical examination evaluations were not summarized. Laboratory abnormalities and vital signs were collected and summarized.|||||
147193|NCT00410410|Secondary|IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147194|NCT00410410|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||participants|||Number
147195|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
147196|NCT00410410|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day OL-1 through Day OL-729|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.||participants|||Number
147197|NCT00410410|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day OL-1 through the end of the OL|All participants who received at least 1 infusion of open-label study medication at any time were included in the safety analyses of the Open-Label Extension phase.||participants|||Number
147198|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|"The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance~=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks."|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
147305|NCT00410072|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||Percentage of participants|||Number
147199|NCT00410410|Primary|Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Month 12 (Day MP-365)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147200|NCT00410410|Secondary|IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
147201|NCT00410410|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for ≥8 weeks.|Week 12 (Day IP-85)|All participants in ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing. Prior inadequate response/intolerance was to an approved anti-TNF agent at an approved labeled dose for ≥8 weeks.||participants|||Number
147202|NCT00410410|Secondary|IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147203|NCT00410410|Secondary|IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147204|NCT00410410|Secondary|IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of ≤1 point was indicative of mild disease.|Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147205|NCT00410410|Secondary|IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline (Day IP-1), Day IP-85 (Week 12)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||units on a scale||Standard Error|Mean
147206|NCT00410410|Secondary|IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C|The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||units on a scale||Standard Deviation|Mean
147250|NCT00410202|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147207|NCT00410410|Secondary|IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147208|NCT00410410|Secondary|IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore ≤ 1 point|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147209|NCT00410410|Secondary|IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point.|Week 12 (Day IP-85)|All participants in the ITT Population were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147210|NCT00410410|Secondary|IP; Baseline Mayo Score: IP1C|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Baseline|The As Treated analysis population was used for all safety summaries and was defined to include all participants who received at least one infusion of study medication.||units on a scale||Standard Deviation|Mean
147211|NCT00410410|Primary|Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C)|The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician’s Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.|Week 12 (Day IP-85)|All participants who were randomized and received at least one infusion of study medication (Intent To Treat Population, ITT) were included in the efficacy analyses. Participants with missing Mayo score were defined as not having achieved clinical response, remission, or mucosal healing.||participants|||Number
147212|NCT00410384|Other Pre-specified|Adverse Event (AE) Overview|SEE ALSO ADVERSE EVENT RESULTS SECTION|Up to 80 Weeks|||Percentage of participants|||Number
147213|NCT00410384|Secondary|Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52||Baseline, Weeks 40-52|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose > 7.5 mg/day.||Percentage of participants|||Number
147214|NCT00410384|Secondary|Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.|The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient’s response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a scale||Standard Error|Mean
147215|NCT00410384|Secondary|Mean Change in Physician's Global Assessment (PGA) at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Scores on a 3-point scale||Standard Error|Mean
147216|NCT00410384|Secondary|Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.||Baseline, 52 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent.||Percentage of participants|||Number
147217|NCT00410384|Secondary|SRI Response Rate at Week 76|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 76 Weeks|Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 76 data.||Percentage of participants|||Number
147545|NCT00408681|Primary|Functional Recovery|Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease.|at 28 days after starting treatment with the study product|||Participants|||Count of Participants
147218|NCT00410384|Primary|SLE Responder Index (SRI) Response Rate at Week 52|"Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E)."|Baseline, 52 Weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data.||Percentage of participants|||Number
147219|NCT00410280|Secondary|Number of Participants With Antibodies to IMA-638||Baseline up to Day 168|ITT population included all randomized participants who received at least 1 dose administration of the test article.||participants|||Number
147220|NCT00410280|Secondary|Serum Decay Half-Life (t1/2) for IMA-638|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||days||Standard Deviation|Mean
147221|NCT00410280|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||mcg*hr/mL||Standard Deviation|Mean
147222|NCT00410280|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638|Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t).|Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
147223|NCT00410280|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||days||Standard Deviation|Mean
147224|NCT00410280|Secondary|Maximum Observed Serum Concentration (Cmax) for IMA-638||Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.||microgram/milliliter(mcg/mL)||Standard Deviation|Mean
147225|NCT00410280|Secondary|Protein Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure w as not analyzed because the study w as stopped early after interim analysis and only safety and key efficacy analyses w ere performed.|||||
147226|NCT00410280|Secondary|Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood|Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.|Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||||
147227|NCT00410280|Secondary|Blood Levels of Interleukin-13 (IL-13)||Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168|Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||||
147228|NCT00410280|Secondary|Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34).|Baseline, Day 8, 13, 21, 34, 56, 84, 168|"ITT population included all randomized participants who received at least 1 dose administration of the test article. Here, n signifies participants evaluated for this measure at the specified time point for each arm."||10^9 cells/Liter||Standard Error|Mean
147229|NCT00410280|Secondary|Total Blood Eosinophil Counts at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on day 13 and 34).|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article.||10^9 cells/Liter||Standard Deviation|Mean
147230|NCT00410280|Secondary|Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34). Results are reported for total IgE count.|Baseline, Day 13, 34, 56, 112, 168|"ITT population. Here, n signifies participants evaluated for this measure at the specified time point for each arm. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed."||kU/L||Standard Error|Mean
147231|NCT00410280|Secondary|Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline|The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge within a given challenge triad (planned on day 13 and 34). The challenge triad included pre-allergen methacholine inhalation challenge, allergen inhalation challenge, and post-allergen methacholine inhalation challenge. Results are reported for total IgE count.|Baseline|ITT population included all randomized participants who received at least 1 dose administration of the test article. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.||kilo unit/liter (kU/L)||Standard Deviation|Mean
147424|NCT00409240|Primary|Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study|Hemoglobin A1C target was < 7% LDL cholesterol goal of < 100mg/dl or <70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of <130mm Hg|6 months|||participants|||Number
147232|NCT00410280|Secondary|Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35|The collected sputum was planned to be analyzed for epithelial cells, eosinophils, lymphocytes, neutrophils, metachromatic cells, or macrophages counts. Sputum induction was to be performed after each methacholine challenge and at 7 hours after each allergen inhalation challenge.|Baseline, Day 14, 35|Data was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.|||||
147233|NCT00410280|Secondary|Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge|Methacholine inhalation test was performed to determine airway hyper-reactivity using provocative concentration 20 (PC20). PC20 was the lowest concentration of methacholine at which participant had 20% decrease from baseline in FEV1. Pre-allergen challenge methacholine inhalation test was performed 1 day prior to the allergen challenge and post-allergen challenge methacholine inhalation test was performed 1 day after to the allergen challenge (that is, pre- and post-allergen methacholine inhalation test was conducted on Day -15 and -13 for Screening allergen challenge, Day 13 and 15 for Day 14 allergen challenge and Day 34 and 36 for Day 35 allergen challenge, respectively). For each methacholine inhalation test, baseline FEV1 was defined as the lowest value among the triplicate readings taken after administration of the diluent (saline administration). Difference between post-allergen challenge and pre-allergen challenge was expressed as log2 (post-allergen PC20 – pre-allergen PC20).|Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge|ITT population included all randomized participants who received at least 1 dose administration of the test article.||Log2 milligram/milliliter (log2 mg/mL)||Standard Deviation|Mean
147234|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 0 to 3 hours at each visit was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop*hour||Standard Deviation|Mean
147235|NCT00410280|Secondary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 >=20% at 0 to 3 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 0 to 3 hours was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
147236|NCT00410280|Secondary|Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of >=15% at 3 to 7 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 3 to 7 hours was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||Percent drop*hour||Standard Deviation|Mean
147237|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
147238|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
147251|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 96|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147239|NCT00410280|Primary|Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening|Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.|Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)|ITT population included all randomized participants who received at least 1 dose administration of the test article.||percent drop||Standard Deviation|Mean
147240|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Serum Chemistry|ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:>1.25*ULN, AST:>1.25*ULN, ALP:>1.25*ULN, Total Bilirubin:>1.1*ULN, Serum Lipase:>1.10*ULN, Creatinine:>1.1*ULN, Blood Urea Nitrogen:1.25*ULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L; ALT flare: on treatment (OT), >2*Baseline and >10*ULN; off treatment (OF), 2*end of dosing value and >10*ULN|On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks|All treated participants. n = number of participants in the OF period.||participants|||Number
147241|NCT00410202|Secondary|Number of Participants With Laboratory Abnormalities: Hematology|Criteria for hematology abnormalities were: Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|From start of study through Week 100 + 5 days|All treated participants.||participants|||Number
147242|NCT00410202|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death.|From start of study therapy through Week 100 + 5 days|All treated participants.||participants|||Number
147243|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 2|"Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 2|Treated participants who were tested for resistance were analyzed, ie. They met the following selection criteria: 1) participants with HBV DNA ≥ 50 IU/mL at Week 96 or at the last on-treatment visit and 2) who developed VBT. n=participants||percentage of participants|||Number
147244|NCT00410202|Secondary|Cumulative Probability of Emergent Genotypic Resistance at Year 1|"yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)."|Year 1|Treated participants who were tested for resistance, ie. met the following selection criteria. 1) participants with HBV DNA ≥ 50 IU/mL at Week 48 or at the last on-treatment visit and 2) who developed VBT . n=participants||percentage of participants|||Number
147245|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147246|NCT00410202|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147247|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 96|Participants who received at least 1 dose of study therapy were analyzed. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147248|NCT00410202|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147252|NCT00410202|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Participants who received at least 1 dose of study therapy and were HBeAG positive. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147253|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1) were analyzed. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147254|NCT00410202|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L.|Week 48|Participants who received at least 1 dose of study therapy and had ALT > 1 x ULN at baseline (day 1). Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147255|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 96|HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load.|Baseline, Week 96|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values were analyzed. n= participants with baseline and Week 96 values.||participants||Standard Error|Mean
147256|NCT00410202|Secondary|Change in Mean log10 From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction.|Baseline, Week 48|Participants who received at least 1 dose of study therapy and had both baseline and post-baseline values. n=participants with baseline and Week 48 values.||log10 (IU/mL||Standard Error|Mean
147257|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay.|Week 96|Participants who received at least 1 dose of study therapy were analyzed.||percentage of participants|||Number
147258|NCT00410202|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay.|Week 48|Participants who received at least 1 dose of study therapy.||percentage of participants|||Number
147259|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147260|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147261|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||Percentage of participants|||Number
147262|NCT00410202|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147263|NCT00410202|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96|HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 96|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||Percentage of participants|||Number
147264|NCT00410202|Primary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed.|Week 48|Participants who received at least 1 dose of study therapy. Participants with missing efficacy assessments were considered as a failure.||percentage of participants|||Number
147501|NCT00408876|Primary|Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 7|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147265|NCT00410189|Primary|8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)|The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|Baseline to 8 Weeks|||percentage of participants|||Number
147266|NCT00410189|Secondary|8 Week Progression-Free Survival|Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.|Every 8 weeks till disease progression.|||months||Full Range|Median
147267|NCT00410163|Secondary|Number of Participants With Progression or Death|Disease progression is characterized by at least one of the following, per the Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia: a >=50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations 2 weeks apart (at least one node must be >=2 centimeters); or the appearance of new palpable lymph nodes; or a >=50% increase in liver and/or spleen size (measurement below the costal margin); or the appearance of palpable hepatomegaly or splenomegaly not previously present; or a >=50% increase in the numbers of circulating lymphocytes to at least 5.0 * 10^9/Liter; or transformation to a more aggressive histology (e.g., Richter’s syndrome or prolymphocytic leukemia with >55% prolymphocytes). For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS||Participants|||Number
147268|NCT00410163|Secondary|Vss After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||liters||Geometric Coefficient of Variation|Geometric Mean
147269|NCT00410163|Secondary|CL After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
147270|NCT00410163|Secondary|t1/2 After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
147271|NCT00410163|Secondary|AUC(0-inf) and AUC(0-672) After the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-672) is AUC from start of infusion to 672 hours after start of infusion; AUC(0-inf) is AUC from start of infusion extrapolated to infinity.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
147272|NCT00410163|Secondary|Ctrough and Cmax at the First Infusion (Visit 2, Week 0) and Sixth Infusion (Visit 29, Week 20)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]). No drug is present before the first infusion; therefore, there are no Ctrough results for the first infusion.|Visit 2 (Week 0; up to 4 weeks after dose) and Visit 29 (Week 20; up to 9 months after dose)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
147273|NCT00410163|Secondary|Number of Participants Classified as Responders Having CR Who Tested Negative for Minimal Residual Disease (MRD)|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment when the participant has achieved CR. For all participants who achieved CR, the follow-up bone marrow sample was tested for malignant B cells (CD5+CD19+) to determine if there was any MRD.|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to course 6 or Week 32)|FAS. Only participants with CR at Visit 34 were analyzed.||participants|||Number
147274|NCT00410163|Primary|Number of Participants (Par.) Who Were Classified as Responders and Non-responders|Par. were evaluated by an IRC in accordance with NCI-WG 1996 guideline. Responders: CR, Nodular Partial Remission (nPR, same as CR, but persistent bone marrow nodules), and Partial Remission (PR, >=50% decrease in lymphocytes from pretreatment baseline (BL) value, >=50% reduction in lymphadenopathy, >=50% reduction of liver/spleen and neutrophils >= 1.5*10^9/L or platelets >100*10^9/L or hemoglobin >11 g/dL (or 50% improvement over BL for neutrophils, platelets, hemoglobin); non-responders: Stable Disease (SD, did not achieve CR/PR, and no PD), Progressive Disease (PD), or Not Evaluable (NE).|From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|FAS||participants|||Number
147275|NCT00410163|Secondary|Percent Change From Screening (Visit 1) in Complement (CH50) Levels at Visit 9 (Week 4)|Blood samples were drawn from participants at Visits 1 and 9 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 9 minus value at Visit 1 divided by value at Visit 1) * 100.|Visit 1 (Week -2) and Visit 9 (Week 4)|FAS. Data were provided for the number of participants attending Visit 9. Participants withdrawn during the study were not analyzed.||Percent change in complement levels||Full Range|Median
149595|NCT00391807|Secondary|Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Days||Standard Deviation|Median
147276|NCT00410163|Secondary|Number of Participants Who Reported Myelosuppression (Anemia, Leukopenia, Neutropenia, and Thrombocytopenia)|Myelosuppression is one of the expected AEs for FC treatment and is defined as the decrease in the ability of the bone marrow to produce blood cells. The number of participants with myelosuppression was assessed from laboratory measurements with Grades 3(severe)-4 (life-threatening/disabling) (1, mild; 2, moderate; 5, death) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. The CTCAE is issued by the National Cancer Institute (NCI) and is the standard classification used for the severity grading scale for AEs in cancer therapy clinical studies.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS||participants|||Number
147277|NCT00410163|Secondary|Number of Participants With Positive Human Anti-human Anti Bodies (HAHA) at Visits 1, 21, 35, and 39|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 21, 35, and 39 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening, Visit -2), 21 (Week 12), 35 (Month 6), and 39 (Month 18)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||participants|||Number
147278|NCT00410163|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 43 (Month 60)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) up to Visit 43 (Month 60)|FAS||participants|||Number
147279|NCT00410163|Secondary|Median Percent Change in CD5+CD19+ and CD5+CD20+ Cells in Peripheral Blood From Onset of Course 3 Throughout Follow-up (FU) Compared to Screening|Malignant B cells (CD5+CD19+ and CD5+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Screening (Visit 1, Week -2) = (value at indicated visits minus value at Visit 1 divided by value at Visit 1) * 100. Visits 33 and 34 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 15 (Wk 8), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in cells||Full Range|Median
147280|NCT00410163|Secondary|Median Percent Change in Tumor Size From Baseline (Visit 2, Wk 0) at Visits 9, 21, 25, 29, 33, 34, 35, and 37|Tumor size was measured by physical examination of palpable abnormal lymph nodes. Percent change from Baseline (Visit 2, Week 0) = (value at indicated visits minus value at Visit 2 divided by value at Visit 2) * 100. Visits 33, 34, 35, 36, and 37 are measured in the number of months from the start of the last infusion. The start of the last infusion could have occurred up to Week 20.|Baseline Visit 2 (Week [Wk] 0); Visits 9 (Wk 4), 21 (Wk 12), 25 (Wk 16), 29 (Wk 20), 33 (Month [M] 1 after start of last infusion [LI]), 34 (M 3 after start of LI), 35 (M 6 after start of LI), 36 (M 9 after start of LI), and 37 (M 12 after start of L|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in tumor size||Full Range|Median
147281|NCT00410163|Secondary|Time to Next Anti-chronic Lymphocytic Leukemia (CLL) Therapy or Death|Time to next anti-CLL (anti-lymphoma) therapy was defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab or death. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From time of randomization to first administration of next anti-CLL therapy other than ofatumumab or death, assessed over 5 years|FAS||months||95% Confidence Interval|Median
147282|NCT00410163|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From time of randomization to first documented evidence of disease progression or death due to any cause, whichever came first, assessed over 2 years|FAS||months||95% Confidence Interval|Median
147283|NCT00410163|Secondary|Duration of Response|The duration of response was defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed.|From time of initial response to disease progression or death, whichever came first, assessed over 2 years|FAS. Only those participants classified as responders were analyzed.||months||95% Confidence Interval|Median
147284|NCT00410163|Primary|Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion|"Par. were evaluated for response by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute-sponsored Working Group (NCI-WG) 1996 guideline. Par. with Complete Remission (CR) were classified as complete responders. As per NCI-WG, CR requires all of the following criteria for a period of >=2 months: absence of lymphadenopathy (all lymph nodes <1.0 centimeters), no hepatomegaly/splenomegaly, absence of constitutional symptoms, lymphocytes <=4.0*10^9/liter (L), neutrophil leukocytes >=1.5*10^9/L, platelets >100*10^9/L, and hemoglobin >11 grams/deciliter."|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment||participants|||Number
147285|NCT00410150|Primary|Length of Stay|Time to discharge eligibility (hours)|Hospital discharge|||hours||Standard Error|Mean
147286|NCT00410124|Secondary|Pharmacokinetics of RAD001: Normalized to Body Surface Area (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||L/hour/m^2||Standard Deviation|Mean
149596|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population||Percentage of Participants|||Number
147287|NCT00410124|Secondary|Pharmacokinetics of RAD001: Apparent Systemic Clearance From Blood Following Extravascular Administration (CL/F)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.Apparent oral clearance of RAD001 (CL/F) was calculated using AUC in a dosing interval of 24 hours (AUC0-24hours) value on Day 15 as: CL/F = dose/ AUC0-τ|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||L/hour||Standard Deviation|Mean
147288|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time of the Last Quantifiable Concentration in a Dosing Interval - (Tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||hour||Full Range|Median
147289|NCT00410124|Secondary|Pharmacokinetics of RAD001: Area Under Curve (AUC) in a Dosing Interval From Time-zero to Time of the Last Quantifiable Concentration. (AUC 0-tlast)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||ng.h/mL||Standard Deviation|Mean
147290|NCT00410124|Secondary|Pharmacokinetics of RAD001: Time at Which C-Max Occurs (t-Max)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose of From Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||h||Full Range|Median
147291|NCT00410124|Secondary|Pharmacokinetics of RAD001:Peak Concentration in a Dosing Interval (C-max); Pre-dose Concentration at 24-h Time Point in Dosing Interval (C-min) and Average Concentration in a Dosing Interval =(C-avg)|Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol. C-avg= Area under curve (AUC) in a dosing interval from time-zero to time of the last quantifiable concentration (AUC0-tlast)/ time of the last quantifiable concentration in a dosing interval (tlast)|At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day1, Cycle 1 Day 15 and at pre-dose from Cycle 2(day1) and all subsequent treatment cycles up until data cut-off 28 Feb 2008.|The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.||ng/mL||Standard Deviation|Mean
147292|NCT00410124|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale (PF)Score of the EORTC QLQ-C30 Questionnaire by at Least 10 Percent Using Kaplan_Meier Method, by Treatment.|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Physical Functioning (PF) sub-scale, consisting of 5 questions each scored from 1 (not at all) to 4 (very much), and with possible values ranging from 5 to 20. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
147293|NCT00410124|Secondary|Time to Definitive Deterioration of the FKS-DRS Risk Score by at Least 2 Score Units Using Kaplan-Meier Method, by Treatment.|"The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. There were 4 response categories (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much), sum of item responses can range from 0 to 36. 0= severely symptomatic patient and the highest score is an asymptomatic patient. Definitive deterioration of the FKSI-DRS score was defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen."|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
147304|NCT00410072|Secondary|Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96|Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.|At Weeks 48 and 96|All treated participants.||Percentage of participants|||Number
147967|NCT00405509|Secondary|Severity of Symptom Scores - COUGH|Cough symptoms were rated by the participant each day for 6 days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30|||units on a scale||Standard Deviation|Mean
147294|NCT00410124|Secondary|Analysis of Time to Definitive Deterioration of the Global Health Status/QoL Scale(QL) Scores of the EORTC QLQ-30 Questionnaire by at Least 10 Percent Using Kaplan Meier Method, by Treatment.|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. Global health status / QoL scale (QL), consisting of 2 questions each scored from 1 (very poor) to 7 (excellent), and with possible scores ranging from 2 to 14. Higher score indicates better functioning. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the patient. Time to definitive deterioration is the number of days between the date of randomization and date of assessment at which definitive deterioration is seen.|"Baseline and every 28 days under treatment and at discontinuation from RAD001 until 28Feb2008 cutoff date"|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
147295|NCT00410124|Secondary|Duration of Response in Patients Who Receive RAD001 Plus BSC Versus Placebo Plus BSC|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR). The start date is the date of first documented response (CR or PR) and the end date is the date of event defined as the first documented progression or death. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||months||95% Confidence Interval|Median
147296|NCT00410124|Secondary|Best Overall Response Rate in Patients Who Receive RAD001 Plus BSC Versus Matching Placebo Plus BSC|The Best Overall Response rate (BOR) is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported, between date of first patient randomized until 28Feb2008 cutoff date|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.||Percentage of Participants||95% Confidence Interval|Number
147297|NCT00410124|Secondary|Overall Survival (OS) Assessed by the Monthly Overall Survival Assessments|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group|Assessed every month up to 2 years after the last patient was randomized into the study from the date of randomization to the time of death. (Data cutoff was 15Nov2009)|Full analysis set was performed on the intent-to-treat population which consisted of all randomized patients.||Months||95% Confidence Interval|Median
147298|NCT00410124|Primary|Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC|Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.|Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.|Full Analysis Set was performed on the intent-to-treat population which consisted of all randomized patients.||Months||95% Confidence Interval|Median
147299|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir|Week 96|Participants with confirmed >= 1 log10 increase in HBV DNA from moving nadir||Participants|||Number
147300|NCT00410072|Secondary|Number of Participants With Virologic Breakthrough at Week 48|ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir|Week 48|Participants with confirmed >=1 log10 increase in HBV DNA from the on-treatment nadir||Participants|||Number
147301|NCT00410072|Secondary|Number of Participants With HBV Resistance at Week 96|ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 96|Participants who received study drug and with HBV DNA levels >=50 IU/mL.||Participants|||Number
147302|NCT00410072|Secondary|Number of Participants With HBV Resistance Through Week 48|ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used.|Week 48|All participants who received study drug and with HBV DNA levels >=50 IU/mL||Participants|||Number
147303|NCT00410072|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 100 + 24-week follow-up|All treated participants.||Participants|||Number
147968|NCT00405509|Secondary|Nasal Secretion Weights|Nasal secretions were collected in pre-weighed tissues and then weighed upon return for nasal secretion weight|each day for 5 days|||grams||Standard Deviation|Mean
147306|NCT00410072|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96|HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||Percent of participants|||Number
147307|NCT00410072|Secondary|Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication.|At Weeks 48 and 96|Treated HBeAg-positive participants. A participant missing the efficacy assessments for a visit was considered a failure and was counted as evaluable.||Percentage of participants|||Number
147308|NCT00410072|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96|HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||Percentage of participants|||Number
147309|NCT00410072|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96|ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and counted as evaluable.||Percentage of participants|||Number
147310|NCT00410072|Secondary|Mean Log 10 HBV DNA at Weeks 48 and 96|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load.|Baseline, Weeks 48 and 96|Evaluable participants at given time point. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||log10 copies/mL||Standard Error|Mean
147311|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96|LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.||Percentage of participants|||Number
147312|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96|LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.||Percentage of participants|||Number
147313|NCT00410072|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Weeks 48 and 96|Evaluable participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||Percentage of participants|||Number
147314|NCT00410072|Primary|Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96|HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.|At Week 96|Evaluable participants. A participant missing the efficacy assessments for a visit is considered a failure and is counted as evaluable.||Percentage of participants|||Number
147315|NCT00410046|Secondary|Change From Baseline Haywood Quality of Life Score From Baseline to Week 38|Haywood quality of life instrument was utilized in the United Kingdom as the ASQoL measure. The ASQoL is an AS-specific measure of QoL, scores range from 0 (good QoL) to 80 (poor QoL). ASQoL is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patient's 0881A3-402 baseline score was used in the analysis. Change=baseline-week 38.|Baseline and 38 weeks|All patients from United Kingdom sites who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug had at least 1 post-baseline assessment and completed 38 weeks.||units on scale||Standard Deviation|Mean
149597|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Percentage of Participants|||Number
147316|NCT00410046|Secondary|Change in Baseline Ankylosing Spondylitis Quality of Life (ASQoL) Score From Baseline to Week 38|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the patient as a ‘Yes’ (scored as 1) or ‘No’ (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). The 0881A3-402 baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug, had at least 1 post-baseline assessment, and completed 38 weeks.||units on scale||Standard Deviation|Mean
147317|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score for Fatigue From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The fatigue-specific score is presented here. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
147318|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score From Baseline to Weeks 38|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
147319|NCT00410046|Primary|Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
147320|NCT00410046|Primary|Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks preceding enrollment in study 0881A3-402 (NCT00247962) and during the 48 weeks of treatment in this extension study (0881A3-405).|96 weeks|All patients who took ETN and completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
147321|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to Week 38|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
147322|NCT00410046|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) Score From Baseline to Week 38|BASFI is a validated self assessment tool that determines the degree of functional limitation in Ankylosing Spodylitis (AS) patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions, with a maximum score of 100 mm. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
147323|NCT00410046|Secondary|Change in Total Back Pain Score From Baseline to Week 38|Total Back Pain was measured on a 0 to 100 mm VAS, with 0 mm indicating no pain. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||units on scale||Standard Deviation|Mean
147324|NCT00410046|Secondary|Change in Patient Global Assessment of Disease Activity From Baseline to Week 38|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity. The 0881A3-402 (NCT00247962) baseline score was used as the baseline for this analysis. Change = baseline - week 38.|Baseline and 38 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment||units on scale||Standard Deviation|Mean
147325|NCT00410046|Secondary|Number of Sick Days Per Patient During the 48 Weeks of Treatment|Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days. The mean number of days is based on those patients who had sick leave during the treatment period.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||Sick days per patient||Full Range|Mean
147326|NCT00410046|Secondary|Number of Patients With Sick Leave During 48 Weeks Treatment|The impact of treatment on work productivity was assessed by sick leave. Patients were asked whether or not they had taken sick leave during the 48 weeks of treatment, and if so, how many days.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
147327|NCT00410046|Secondary|Number of Times Healthcare Resources Were Used Per Patient During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking all patients whether or not they had used the healthcare resource during the 48 weeks of treatment, and if so, how many times the resource was used. The mean number of times is based on those patients who responded to the questionnaire stating they had utilized healthcare resources (see outcome measure 3).|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into study 0881A3-405, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||# of times utilized per patient||Full Range|Mean
147328|NCT00410046|Secondary|Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment|Healthcare resources were defined as hospital admissions, therapeutic warm baths, physiotherapist visits, and outpatient physician visits. Healthcare resource utilization was evaluated using a questionnaire asking patients whether or not they had used the healthcare resource during the 48 weeks of treatment.|48 weeks|All patients who completed study 0881A3-402 (NCT00247962), continued into this study, received at least 1 dose of study drug and had at least 1 post-baseline assessment.||patients|||Number
147329|NCT00409838|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.||mm/h||Standard Error|Mean
147330|NCT00409838|Secondary|Change From Baseline in Levels of C-reactive Protein (CRP)||Days 169 to 1569|Participants who completed the Short-term Period. n=Number of evaluable participants.||mg/dL||Standard Error|Mean
147331|NCT00409838|Secondary|Percentage of Participants With Low Disease Activity Score (LDAS) or Who Are in Remission|LDAS is defined as a Disease Activity Score C-reactive protein (DAS28-CRP) level <=3.2. Remission is defined as a DAS28-CRP level <2.6.|At Days 169, 337, 729, 1149, and 1485|All participants who finished the Short-term period. n=Number of evaluable participants||Percentage of participants||95% Confidence Interval|Number
147332|NCT00409838|Secondary|Changes From Baseline in the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) Scores|The SDAI is the sum of 5 parameters: Tender joint (TJC) and swollen joint(SJC)counts, based on a 28-joint assessment; patient global (PtGA)and physician global assessments (PGA), assessed on 0-10 cm visual analog scale (VAS), on which higher scores=greater affection due to disease activity DA); and C-reactive protein level. SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low DA, >11 to 26=moderate DA, and >26=high DA. SJC is assessed at each visit, with no swelling=0, swelling=1. TJC is assessed through identification of joints painful under pressure or to passive motion at each visit, with no tenderness=0, tenderness=1. Higher score=greater affection due to DA. CDAI is sum of 4 parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score=0-76. CDAI <=2.8 indicates disease remission, >2.8 to 10=low DA, >10 to 22=moderate DA, and >22=high DA.|At Days 169 and 1569|All participants who received study drug and who were evaluable||Units on a scale||95% Confidence Interval|Mean
147333|NCT00409838|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and With EULAR-defined Remission|EULAR defines LDAS as a disease activity score as measured by c-reactive protein (DAS28-CRP) ≤3.2 and remission as DAS28-CRP <2.6|At Days 169 and 1485|All participants who received study drug and who were evaluable||Percentage of participants|||Number
147334|NCT00409838|Secondary|Changes From Baseline in Short-Form 36 (SF-36) Physical and Mental Health Summaries|The SF-36 is a 36-item questionnaire used to measure Quality of Life over 8 physically and emotionally based areas: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Answers to each question correspond to a precoded numeric value. An aggregate percentage score is reached for each of the 8 sections and is based on answers to questions. The mean average is worked out for each section. Scores range from 0% (lowest level of functioning) to 100% (highest level of functioning, with higher score indicated increasing levels of functioning.|At Day 1485|All participants who received study drug and who were evaluable||Units on a scale||Standard Error|Mean
147335|NCT00409838|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|Day 1485|All participants who received study drug and who were evaluable||Units on a scale||Standard Error|Mean
147336|NCT00409838|Secondary|Percentage of Participants With Physical Function Response as Assessed Using the Health Assessment Questionnaire Disability Index (HAQ-DI)|Improvement is measured by an improved response of at least 0.3 units from baseline on the HAQ-DI score. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|At Day 1485|All participants who received study drug and who were evaluable||Percentage of participants|||Number
147337|NCT00409838|Secondary|Percentage of Participants Achieving ACR20, ACR50, and ACR70 Over Time|The ACR 20, ACR50, and ACR70 are based on 20%, 50% and 70% improvement, respectively, (compared with baseline values) in tender and swollen joint counts and on 20%, 50% and 70%, respectively, improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|Days 15 through 1569|All participants who completed the ST period and received at least 1 infusion of abatacept during the LTE period. n=evaluable participants at that timepoint for that measure.||Percentage of participants||95% Confidence Interval|Number
147338|NCT00409838|Secondary|LTE Period: Overall Number of Participants With Positive Results of Immunogenicity Samples|Positive antibody titers were identified by validated enzyme-linked immunosorbent assay results. On-treatment samples were obtained during the LTE period, and posttreatment samples were following the last infusion of study medication.|Days 169, at 6-month intervals on-treatment, and at Days 28, 56, and 85 after the last infusion of study medication in the LTE period|All participants who during the LTE period, received at least 1 infusion of abatacept and had at least 1 immunogenicity sample collected.||Participants|||Number
147339|NCT00409838|Primary|Long-term Extension (LTE) (Open-Label) Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuatons Due to SAEs, Adverse Events (AEs), Related AEs, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Day 169 to up to 56 days post the last dose (Day 1485) in the LTE period|All participants who completed the short-term period and received at least 1 infusion of abatacept during the LTE period||Participants|||Number
147340|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Rheumatoid Factor (RF) at Day 169|Mean change in RF. A surrogate marker is an indirect measurement of effectiveness. Mean change from Baseline = postbaseline - baseline value.|Baseline, Day 169|All Randomized and Treated Participants. The summary was based on the last observation carried forward (LOCF) procedure. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.||IU/mL||Standard Error|Mean
147341|NCT00409838|Secondary|Change From Baseline in Surrogate Marker Erythrocyte Sedimentation Rate (ESR) at Day 169|Mean change in surrogate marker mean ESR. A surrogate marker is an indirect measurement of effectiveness. Change from Baseline = postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug. Participants with baseline and post-baseline measurements were included, not the participants who had only baseline measurements.||mm/h||Standard Error|Mean
147342|NCT00409838|Secondary|Immunogenicity of Abatacept- Number of Participants With Reactivity Toward CTLA4-IG and CTLA4-T at Day 169|Immunogenicity was determined by measuring adult subject sera for reactivity against the whole Abatacept molecule (CTLA4Ig) and CTLA4-T (CTLA4 without the Ig regions).|Day 169|All participants who received study drug (abatacept)||participants|||Number
147343|NCT00409838|Secondary|Summary Statistics of Minimum Observed Serum Concentration (Cmin) for Abatacept|Minimum concentration (Cmin) of Abatacept 500 mg and 750 mg at given time points|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85|Participants with measurement at timepoint||μg/mL||Standard Deviation|Mean
147344|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Volume at Steady State (VSS)|The volume of distribution of drug at steady state (VSS). Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level||L/kg||Standard Deviation|Mean
147345|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Total Body Clearance (CLT)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Clearance is a pharmacokinetic parameter that describes how quickly drugs are eliminated, metabolized or distributed throughout the body.|Day 29, every 28 days until Day 141|Participants with measurement at stated dose level||mL/h/kg||Standard Deviation|Mean
147346|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Area Under the Curve (AUC)|Area Under the Plasma Concentration-Time Curve (AUC), a measure of drug absorption, in a dosing interval of 28 days from Day 85 to Day 113. Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg.|At the end of infusion, 2 to 4 hours after the start of infusion on Day 85, anytime between Day 92 and 96, and predose on Day 113|Participants with measurement at stated dose level||μg.h/mL||Standard Deviation|Mean
147347|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters - Maximum Concentration (Cmax)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Maximum Concentration (Cmax)= the maximum plasma concentration of the drug.|At the end of infusion and 2 to 4 hours after the start of the infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level||μg/mL||Standard Deviation|Mean
147348|NCT00409838|Secondary|Abatacept Pharmacokinetic (PK) Parameters: Time to Maximum Concentration (Tmax) and Half-Life of Elimination (T-Half)|Steady-state PK parameters following administration of body-weight tiered doses approximating 10 mg/kg. Tmax = the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. T-Half = the biological half-life or elimination half life of a substance is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.|At the end of infusion and 2 to 4 hours after the start of infusion on Day 85, at anytime between Day 92 and 96, and pre-dose on Day 113|Participants with measurement at stated dose level||Hours||Standard Deviation|Mean
147349|NCT00409838|Secondary|Percentage of Participants Experiencing Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), Related SAEs and AEs, and Discontinuations Due to SAEs and AEs During the Double-Blind Period|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout double-blind study period (up to Day 169); table includes data up to 56 days past double-blind period or start of the open-label period, whichever occurred first.|All randomized participants who received study drug.||Percentage of participants|||Number
147350|NCT00409838|Secondary|Change From Baseline to Day 169 in Analysis of Short-Form 36 (SF-36) Health Survey Questionnaire Domains|Adjusted mean change from baseline. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life and comprised of 8 domains( including 4 physical and 4 mental subscales) used to derive the physical and mental component summary scores. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Change from baseline=postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug and were evaluable.||Units on a scale||Standard Error|Mean
147351|NCT00409838|Secondary|Change From Baseline to Day 169 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|Adjusted mean change from baseline. The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning. Patients respond on a scale from 0 (no disability) to 3 (completely disabled); total possible score=24. Higher score indicates greater disability. Change from baseline= postbaseline - baseline value.|From Baseline to Day 169|All randomized participants who received study drug||Units on a scale||Standard Error|Mean
147352|NCT00409838|Secondary|Change From Baseline in Disease Activity Scores (DAS) Based on C-reactive Protein (DAS 28 [CRP]) Levels or Erythrocyte Sedimentation Rate (DAS 28[ESR])|Adjusted mean change from baseline. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission). CRP or ESR give estimations of DAS28 values on a group level. Change from Baseline=Postbaseline - Baseline value.|From Baseline to Days 169 and 1485|All randomized participants who received study drug and who were evaluable.||Units on a scale||Standard Error|Mean
147353|NCT00409838|Secondary|Percentage of Participants With at Least 20%, 50%, or 70% Improvement From Baseline in American College of Rheumatology (ACR) Core Components|The ACR defines improvement in core components as 20%, 50%, or 70% improvement in tender and swollen joint counts and 3 of the remaining core components: patient global assessment of disease activity, physician global assessment of disease activity, patient assessment of pain, patient self-assessed disability (Health Assessment Questionnaire Disability Index [HAQ-DI]), and levels of 1 acute phase reactant (C-reactive protein levels or erythrocyte sedimentation rate.) The HAQ-DI assesses a patient's level of functional ability via 20 questions in 8 categories of functioning; scale=0 (no disability) to 3 (completely disabled); total possible score=24. The higher the score, the greater the disability.|From Baseline to Day 169|All randomized participants who received study drug and who were evaluable.||Percentage of participants|||Number
147354|NCT00409838|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 and ACR70 Response at Day 169|The ACR defines ACR 50 and ACR70 response as a 50% or 70% improvement (compared with baseline values) in tender and swollen joint counts and 50% or 70% improvement in 3 of the remaining 5 core set measures (patient global assessment of pain, patient global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and 1 acute phase reactant value (C-reactive protein).|At Day 169|All randomized participants who received study drug.||Percentage of participants|||Number
147355|NCT00409838|Primary|Percentage of Participants Meeting the Criteria of the American College of Rheumatology for 20% Improvement (ACR20)|The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.|At Day 169|All randomized participants who received study drug.||percentage of participants|||Number
147356|NCT00409825|Primary|Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.|"Change in the area under the concentration vs. time curve in the second and third trimesters of pregnancy.~We compared AUC at each PK study visit. Measurements were obtained at 0, 1, 2, 3, 4, 5, 6, 7 days."|Second and third trimesters of pregnancy|||ng/ML/day||Standard Deviation|Mean
147357|NCT00409786|Secondary|Physical Activity||1 year||||||
147358|NCT00409786|Secondary|Health Related Quality of Life||1 year||||||
147359|NCT00409786|Secondary|Fat Consumption||1 year||||||
147360|NCT00409786|Secondary|A1C (if Applicable)||1 year||||||
147361|NCT00409786|Secondary|Lipid||1 year||||||
147362|NCT00409786|Secondary|Blood Pressure||1 year||||||
147363|NCT00409786|Primary|Change in Weight||Baseline and 1 year|Of the original 50 participants, 12 month data was collected for 45 (90%) of them. Analysis was conducted on those participants with 12 month data.||kg||95% Confidence Interval|Mean
147364|NCT00409773|Secondary|Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Median
147365|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147366|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147367|NCT00409773|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147368|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6||Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
149598|NCT00391807|Secondary|Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Percentage of Participants|||Number
147369|NCT00409773|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147370|NCT00409773|Secondary|Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147371|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147372|NCT00409773|Secondary|Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147373|NCT00409773|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147374|NCT00409773|Secondary|Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147375|NCT00409773|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147376|NCT00409773|Secondary|Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Median
147377|NCT00409773|Secondary|Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147378|NCT00409773|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6||Baseline and 6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
147379|NCT00409747|Secondary|Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985)|This instrument has two scales – Severity (CGI-S). The CGI-S is a seven point scale with a minimum score of 1 and a maximum score as 7 as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline and 6 months|All children completing 6 months of drug and participating in final evaluation||mean scores on global impression scale||Standard Deviation|Mean
147380|NCT00409747|Primary|z Score|"The Mann–Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects.~Pre and post treatment measurements of csf analytes: TNF alpha, Il-6, CCL-2(MCP-1), CCL3 (MIP-1alpha), CCL5(RANTES), CXCL(IL-8), BDNF, CD40L, GDNF, HGF, Leptin"|Pre and post treatment with minocyline at 6 months for 10 subjects|10 subjects completed six months of minocycline and have pre-/post-minocycline CSF samples for analysis.||Z-score|||Number
147381|NCT00409708|Primary|The Number of Micronuclei Per 1000 Binucleated Cells Endpoints at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of micronuclei per 1000 binucleated cells was measured at Baseline ( n=34 , n=29 ) and at the end of treatment, Week 12 (n =34, n= 29), in blood cultured for 48 hours using a standard protocol.|baseline and at end of treatment (Week 12)|||number of micronuclei per 1000 binucleat||Standard Deviation|Mean
147425|NCT00409188|Secondary|Number of Participants With Treatment Emergent Adverse Events and Injection Site Reactions|Treatment -emergent adverse events were defined as those with onset or worsening occurring at or after the first dosing day of study medication and up to 42 days after the last administration of any study drug or the clinical cut-off date. Injection site reactions were reported as assessed by the Investigator.|From first dose up to 42 days after the last dose of the trial treatment|Safety analysis set included all participants who received at least 1 dose of trial treatment (cyclophosphamide, tecemotide, saline, or placebo). Participants were reported based on the actual treatment received (as-treated).||participants|||Number
147382|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Severity of Illness Rating of the Clinical Global Impression Scale (CGI-S)|The Clinical Global Impression scale (CGI-S) is a clinician-rated instrument designed to assess the severity of illness. The CGI-S rating indicates illness severity at each time-point on a scale as follows: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. CGI-S assessments are relative to the patient’s status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||Units on a rating scale||Standard Deviation|Mean
147383|NCT00409708|Secondary|Change From Baseline to the End of Treatment (Week 12) on the Global Improvement Rating of the Clinical Global Impression Scale (CGI-I)|The Clinical Global Impression scale (CGI-I) is a clinician-rated instrument designed to assess the overall change of illness relative to baseline. The CGI-I consists of 7 ratings as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I assessments are relative to the patient’s status at the Baseline visit.|From baseline to the end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||Units on a rating scale||Standard Deviation|Mean
147384|NCT00409708|Secondary|Change From Baseline to End of Treatment (Week 12) on the Conners' ADHD/DSM-IV Scale for Parents (CADS-P)|"Parents completed the Conners' ADHD/DSM-IV Scale for Parents (CADS-P) consisting of the ADHD Index (12 items) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)( 18 items). Parents rated their child's behavior of the previous week from a list of common problems. When asked How much of a problem has this been in the last week?” parents selected 0 = none, not at all, seldom, or very infrequently; 3 = very much true, or it occurs very often or frequently; or 1 or 2 for ratings in between. A score of 50 is considered normal and more than 70 markedly atypical."|Baseline to end of treatment (Week 12)|Per-Protocol-2 (PP2) Population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||Units on a rating scale||Standard Deviation|Mean
147385|NCT00409708|Secondary|Pharmacokinetic/Pharmacodynamic Relationship of Methylphenidate Blood Levels and Cytogenetic Changes|Since no cytogenetic effects were observed, blood samples were not analyzed for pharmacokinetics/pharmacodynamics.|End of treatment (Week 12)|||Number|||Number
147386|NCT00409708|Secondary|Number of Sister Chromatoid Exchanges Per Cell|Blood collected at baseline (n=20, n=14) and at the end of treatment, Week 12, (n= 20, n= 14) was cultured for 48 hours using a standard protocol. Giemsa staining and/or fluorescent in situ hybridization (FISH) chromosome painting was done on the cells in metaphase and the number of chromatoid exchanges per cell was recorded by blinded raters.|baseline and at end of treatment (Week 12)|Per-Protocol-2 population: The PP2 population consisted of all subjects who were randomized and provided at least one post-baseline efficacy assessment.||number of sister chromatoid exchanges||Standard Deviation|Mean
147387|NCT00409708|Primary|The Number of Chromosomal Aberrations Per 100 Cells Excluding Gaps at Baseline and at the End of Treatment i.e Day 84 (Week 12)|The number of chromosomal aberrations per 100 cells excluding gaps at Baseline (n=33, n=32) and at Week 12 (n=33, n=32) was counted in blood samples cultured for 48 hours using a standard protocol. The types of abnormalities included translocations (reciprocal and non-reciprocal), insertions, dicentrics, fragments, inversions, chromatid exchanges (quadriradials and triradials), breaks, and other unusual observations, eg, aneuploidy, tetraploidy or endoreduplication.|baseline and at end of treatment (Week 12)|Per-Protocol-1 (PP1) population: The PP1 population consisted of all patients who were randomized and provided cytogenetic data for at least one of the primary endpoints at baseline and at the Week 12 evaluation.||number of abnormalities||Standard Deviation|Mean
147388|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 52 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 52|Intent-to-treat (ITT) population for observed case (OC).||Scores on a scale||Standard Deviation|Mean
147389|NCT00409682|Secondary|Change From Baseline IMPACT III Scores at Week 26 (Observed Case)|The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease [CD] or ulcerative colitis). In this study, subjects greater than or equal 10 years old who had CD at baseline completed an IMPACT III questionnaire at Baseline, Week 26, and Week 52. Subjects marked an option from 1 to 5 for each item left to right with numbers 5 (good 'quality of life' condition) through 1 (bad 'quality of life' condition). The total scores, range from 35 to 175 with higher scores representing a better quality of life.|Baseline and Week 26|Intent-to-treat (ITT) population for observed case (OC).||Scores on a scale||Standard Deviation|Mean
147390|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 52|Intent-to-treat population using non-responder imputation (NRI) method.||percent of participants|||Number
147426|NCT00409188|Secondary|One-, Two- and Three-year Survival Rate|The percentages of participants who were alive at 1, 2, and 3 years were calculated as a cumulative percentage by Kaplan-Meier survival analysis approach.|Years 1, 2, and 3|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.||percentage of participants|||Number
147391|NCT00409682|Secondary|Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical response was defined as a decrease from Baseline in the PCDAI score of at least 15 points. The comparison was High-Dose adalimumab versus Low-Dose in the ITT population.|Week 26|Intent-to-treat population using non-responder imputation (NRI) method.||percent of participants|||Number
147392|NCT00409682|Secondary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 52|"Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100 with higher scores indicating more active disease. Clinical remission was defined as PCDAI score of ≤ 10.~The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to treat population."|Week 52|Intent-to-treat population using non-responder imputation method.||percent of participants|||Number
147393|NCT00409682|Primary|Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤ 10 at Week 26|Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.|Week 26|Comparison of adalimumab High-Dose versus Low-Dose with respect to the primary efficacy endpoint in the intent-to-treat analysis set as all randomized subjects who received at least one dose of double-blind study medication.||percent of participants|||Number
147394|NCT00409617|Secondary|Mean Change in Activity Impairment Score From Baseline to Week 20|Daily activity is one component of the Work Productivity and Activity Impairment Questionnaire. 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used. Data for 902 participants were available for calculating change from Baseline at Week 20 of treatment. Missing values were imputed by LOCF.||Percent activity impairment||Standard Deviation|Mean
147395|NCT00409617|Secondary|Mean Change in Overall Work Productivity and Activity Impairment Score From Baseline to Week 20|6-items that assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID).|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 346 participants for the calculation of mean change in Overall Impairment from Baseline to Week 20. Data were imputed using LOCF.||Percent total impairment||Standard Deviation|Mean
147396|NCT00409617|Secondary|Mean Change in Percent Impairment While Working From Baseline to Week 20 of Treatment|Percent impairment while working is a component of the Work Productivity and Activity Impairment measure. A score of 0% = no impairment. A decrease in mean score indicates lessening of impairment.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. Data were available for 382 participants for the calculation of mean change in Percent Impairment While Working from Baseline to Week 20. Data were imputed using LOCF.||Percent impairment at work||Standard Deviation|Mean
147397|NCT00409617|Secondary|Mean Change in Percent Work Time Missed Due to Crohn's Disease From Baseline to Week 20 of Treatment|Percent Work Time Missed (Absenteeism) due to CD is one component of the Work Productivity and Activity Impairment (WPAI) Questionnaire. Score of 0% = no impairment. A decrease in the mean indicates improvement.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 369 participants had data available for calculating change in Percent Work Time Missed. Missing values were imputed using LOCF.||Percent of work time missed||Standard Deviation|Mean
147398|NCT00409617|Secondary|Mean Change in Total Score of Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline to Week 20|10-item assessment of health-related quality of life (QoL) in patients with inflammatory bowel disease. Participant marks an option from 1 to 7 for each item. For some items, 1=None of the time; for other items, 1=All of the time. Value for all items are summed. Total score=10 to 70; a high score=good quality of life (QoL). An increase in score indicates improvement. An absolute change in the SIBDQ score of 9 is considered a minimum clinically important difference (MCID) for a patient.|Week 20 of treatment|The ITT population, defined as participants who received at least 1 injection of adalimumab, was used in the analysis. 907 participants had data available for calculating change in total score of SIBDQ. Missing values were imputed using LOCF.||Change in total score||Standard Deviation|Mean
147399|NCT00409617|Secondary|Number of Participants Who Had Extra-intestinal Manifestations (EIM) at Baseline and Resolution by Week 20.|Number of participants who had EIM at baseline and had resolution of those manifestations at Week 20. EIM were skin lesions, eye lesions, joint complaints, CD-related hepatic disease, thrombosis, and nephrolithiasis. EIMs were determined by physical examination.|Week 20 of treatment|"497 participants who received at least 1 injection of adalimumab (ITT population) had baseline EIM data. Missing data were imputed using non-responder imputation; participants who discontinued the study before Week 20 and participants with missing value at Week 20 were counted as no for resolution."||Participants|||Number
147502|NCT00408876|Primary|Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 6|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147400|NCT00409617|Secondary|Number of Participants Who Had a Reduction in Number of Draining Fistulas of at Least 50% From Baseline to Week 20|A count of the number of cutaneous fistulas draining was performed during each physical examination. Among participants who had draining fistulas at Baseline, the number of participants who had a reduction in the number of draining fistulas of at least 50% from Baseline to Week 20 of treatment was determined. Fistulas were classified as abdominal or perianal.|Week 20 of treatment|171 participants in the ITT population (participants who received at least 1 injection of adalimumab) had draining fistulas at baseline. Data were available for 148 of the 171 participants at Week 20 of treatment. Missing values were not imputed.||Participants|||Number
147401|NCT00409617|Secondary|Number of Participants Who Were Responders at Week 20 of Treatment. A Responder Was Defined as a Participant Who Had a Decrease of 3 or More on the HBI.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Participants who had a decrease from Baseline of at least 3 points in HBI total score were considered responders. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"ITT Population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for response."||Participants|||Number
147402|NCT00409617|Primary|Number of Participants in Clinical Remission at Treatment Week 20. Clinical Remission Defined as Harvey Bradshaw Index (HBI) Score Less Than 5.|5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).|Week 20 of treatment|"Intent-to-treat (ITT) population, defined as all participants who received at least 1 injection of adalimumab. Missing data were imputed using non-responder imputation; participants who discontinued the study prior to Week 20 and participants with no score on the Harvey-Bradshaw Index (missing value) at Week 20 were counted as no for remission."||Participants|||Number
147403|NCT00409578|Secondary|Percentage of Patients With a Composite Clinical-biochemical Event|A composite clinical-biochemical event was defined as at least one of the following events: cardiovascular death confirmed by adjudication, recurrent MI confirmed by adjudication, hospitalization for CHF confirmed by adjudication, and/or NT-proBNP => 200 pg/mL.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||Percentage of patients|||Number
147404|NCT00409578|Secondary|Percentage of Patients With a Cardiac Event|A cardiac event was defined as at least one of the following events: Cardiovascular death, recurrent myocardial infarction (MI), or hospitalization for congestive heart failure (CHF), all to be confirmed by adjudication.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||Percentage of patients|||Number
147405|NCT00409578|Secondary|Change From Baseline in B-type Natriuretic Peptide (BNP) at Week 8|Blood samples for the measurement of BNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||pg/mL||95% Confidence Interval|Geometric Mean
147406|NCT00409578|Primary|Change From Baseline in N-terminal proB-type Natriuretic Peptide (NT-proBNP) at Week 8|Blood samples for the measurement of NT-proBNP were collected, processed, and shipped to the TIMI Biomarker Core Laboratory, Boston MA for storage and analysis. The change from baseline to Week 8 was expressed as the geometric mean of the ratio: Week 8/Baseline.|Baseline to Week 8|Full analysis set: All patients who were correctly randomized. Missing baseline values were not imputed. The last post-baseline biomarker measurement collected was used for analysis. In the aliskiren treated group, 4 patients never received study drug but were included in the full analysis set but were not included in any efficacy analyses.||pg/mL||95% Confidence Interval|Geometric Mean
147407|NCT00409565|Secondary|To Determine the Progression-free Survival and Overall Survival of Patients With Recurrent or Metastatic Head and Neck Cancer Treated With Cetuximab Plus Bevacizumab.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Duration of overall response: measured from the time measurement criteria are met for CR or PR until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since treatment started.|5 years|All patients included in study are assessed for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.||Months||95% Confidence Interval|Median
147538|NCT00408681|Secondary|Recurrent or Progressive Malignancy||2 years after enrollment|||Participants|||Count of Participants
147539|NCT00408681|Secondary|Mucosal Anatomic Response|See prior description.|9 to 11 weeks after starting treatment with the study product|||Participants|||Count of Participants
147408|NCT00409565|Primary|To Determine the Objective Response Rate (Primary Endpoint) With the Combination of Cetuximab Plus Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|5 years|Assess all patients included in this study for response to treatment, per protocol. Of 46 eligible patients, 45 were evaluable for response.||percentage of participants||95% Confidence Interval|Number
147409|NCT00409539|Secondary|To Assess the Safety and Tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d) Following 8-weeks of Treatment in Patients With Over Active Bladder Syndrome|Treatment emergent adverse event summary|8 Weeks|||participants|||Number
147410|NCT00409539|Primary|Change From Baseline to Week 8 in the Number of Voids/24 Hours||8 Weeks|||voids/24 hrs.||Standard Error|Least Squares Mean
147411|NCT00409409|Primary|Average Rhinoconjunctivitis Total Symptom Score (ARTSS)|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.~Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 38.6 days)|The Intent-to-treat (ITT) population included all patients who received at least one dose of the investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
147412|NCT00409344|Primary|Intensive Care Unit Length of Stay|The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.|1/1/2008|||Days|||Number
147413|NCT00409344|Secondary|Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed|Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.|1/1/2008|||participants|||Number
147414|NCT00409344|Secondary|Pharmaco-economics|Did not achieve this outcome due to no enrollment of participants|1/1/2008|||participants|||Number
147415|NCT00409344|Secondary|Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability|Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome|1/1/2008|||participants|||Number
147416|NCT00409344|Secondary|Time to Extubation|Did not achieve this outcome due to no enrollment of participants|1/1/2008|||hours|||Number
147417|NCT00409344|Secondary|Secondary Endpoints Include:Amount of Sedative and Opiates Given|Did not achieve this outcome due to no enrollment of participants|1/1/2008|||milligram of sedative an opiate|||Number
147418|NCT00409344|Primary|Time to a Successful Spontaneous Breathing Trial.|Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.|1/1/2008|||hours|||Number
147419|NCT00409331|Primary|12-month Clinically Relevant Salivary Flow (CRSF)|Primary endpoint is bilateral, 12-month Clinically Relevant Salivary Flow (CRSF) by the submandibular and sublingual salivary glands, collectively. Saliva production will be quantified using selective quantitative submandibular sialometry (total collection time of 5 minutes). A CRSF is equivalent to production of 0.05 mL of saliva post-radiation in a 5-minute collection period.|12 months|No analysis performed; study terminated early due to change in sponsor.|||||
147420|NCT00409292|Secondary|to Assess Overall Survival Associated With RAD001 in This Patient Population.|Overall survival was defined as the time from study entry until death from any cause.|2 years|||months||Full Range|Median
147421|NCT00409292|Secondary|to Assess Response Rate Associated With RAD001 in This Patient Population.|The secondary objectives of the study were to assess tumor response rate and overall survival. Patients were required to have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST, for target lesions assessed by CT: Complete Response (CR) is Disappearance of all target lesions; Partial Response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) equals CR + PR.|2 years|Of the 33 patients enrolled, 29 reached restaging. Three patients who did not reach restaging were removed from study because of withdrawal of consent. One patient was removed from study after 8 days of treatment because of worsening of a preexisting perirectal fistula, requiring surgical intervention.||participants|||Number
147422|NCT00409292|Secondary|To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. The number of patients with treatment-related adverse events are reported.|Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001.|A total of 33 eligible patients received at least 1 week of study drug and are included in our toxicity analyses.||participants|||Number
147423|NCT00409292|Primary|To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.|"The Outcome Measure is reporting the number of participants experiencing Progression-free Survival at 2 months after treatment.~The study was designed with a primary end point of progression-free survival (PFS), defined as the time from study entry to documentation of progressive disease or death from any cause. On the basis of prior studies of second-line treatment in metastatic pancreatic cancer, we estimated that such treatment has been associated with a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population."|two months|On the basis of prior studies of 2nd line treatment in metastatic pancreatic cancer, we estimated a median PFS of 2 months. Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this population.||participants|||Number
147427|NCT00409188|Secondary|Time To Progression (TTP)|Time from randomization to disease progression. Disease progression was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 [RECIST v1.0]) as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions.|Up to 66 months|Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.||months||95% Confidence Interval|Median
147428|NCT00409188|Secondary|Time To Symptom Progression (TTSP) as Measured by the Lung Cancer Symptom Scale (LCSS)|Time to symptom progression (TTSP) was measured by LCSS. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale – ranging from 0 to 100 where higher score indicates worst outcome). Worsening was defined as a 10% increase in the scale breadth from the baseline score. TTSP is defined as the time from randomization to worsening in ASBI. Participants without event are censored at the date of the last LCSS assessment.|Up to 66 months|"Primary analysis set (modified ITT population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold. N signifies the number of participants who were evaluable for this outcome measure."||months||95% Confidence Interval|Median
147429|NCT00409188|Primary|Overall Survival|Overall survival time was defined as the time from randomization to death. Participants without events were censored at the last date they were known to be alive or the clinical cut-off date, whatever was earlier.|Up to 66 months|Primary analysis set (modified intention-to-treat [ITT] population) was based on the ITT population but prospectively excluded all participants (274 participants) that were randomized during the 6 months (22 Sep 2009 to 22 Mar 2010) prior to the effective date of clinical hold.||months||95% Confidence Interval|Median
147430|NCT00409175|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Week 8, Month 6, 12, 18|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||percentage of participants||95% Confidence Interval|Number
147431|NCT00409175|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6, 12 and 18|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation associated with malnutrition. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
147432|NCT00409175|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6, 12 and 18|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
147433|NCT00409175|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6, 12 and 18|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
147434|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6, 12 and 18|Norfolk QOL-DN:35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptom present, 0=symptom absent. Item 8-35: scored on 5-point Likert scale: 0=no problem, 4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment, for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. ‘n’ = those participants who were evaluable for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
147443|NCT00409006|Secondary|Number of Participants With Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.|Baseline to measured response or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy.||Participants|||Number
147435|NCT00409175|Secondary|Change From Baseline in Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
147436|NCT00409175|Secondary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6 and 12|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to <2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0 (normal) to 4 (paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 6, 12|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. LOCF method was used; participant who discontinued due to death/LT was set non-responder.||percentage of participants||95% Confidence Interval|Number
147437|NCT00409175|Secondary|Change From Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) Score at Month 6, 12 and 18|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12, 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death/LT. ‘n’ = those participants who were evaluable for this measure at given time point for each group respectively.||units on a scale||Standard Deviation|Mean
147438|NCT00409175|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 18|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptom was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 18|ITT population included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment for NIS-LL and Norfolk QOL-DN or discontinued study due to death or LT. LOCF method was used.||units on a scale||Standard Deviation|Mean
147439|NCT00409175|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18|Response to treatment was indicated by either improvement (decrease from baseline) or stabilization (change from baseline of 0 to less than[<] 2) in NIS-LL score, based on mean of 2 scores in 1 week period. NIS-LL: assessed muscle weakness, reflexes, sensation. Each item scored separately for left, right limbs. Components of muscle weakness scored on 0(normal) to 4(paralysis) scale, higher score=greater weakness. Components of reflexes, sensation scored 0=normal, 1=decreased, or 2=absent. Total NIS-LL score range 0-88, higher score=greater impairment.|Month 18|ITTset:randomized participants received atleast(>=)1 dose of study drug, had >=1 post-baseline efficacy assessment for NIS-LL,Norfolk Quality of Life-Diabetic Neuropathy(QOL-DN) or discontinued study due to death/liver transplant(LT).Last-observation-carried-forward(LOCF) used;participant who discontinued due to death/LT was set non-responder.||percentage of participants||95% Confidence Interval|Number
147440|NCT00409006|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.|Baseline to date of death from any cause, 12 weeks up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). Median overall survival could not be estimated as most participants were living at the end of the study.||Months||95% Confidence Interval|Median
147441|NCT00409006|Post-Hoc|Percentage of Participants Who Died During the Study|This outcome measure takes the place of the outcome measure for Overall Survival, which could not be reported since the median value could not be calculated.|Baseline up to 31 months|Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). 25 participants from each treatment group were censored.||Percentage of Participants|||Number
147442|NCT00409006|Secondary|Duration of Response for Responders|The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.|Time of response to progressive disease or death, 12 weeks up to 31 months|Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy. Patients were censored for this analysis (2 pemetrexed/cisplatin/gefitinib and 2 pemetrexed/cisplatin).||Months||95% Confidence Interval|Median
147444|NCT00409006|Primary|Progression-Free Survival (PFS)|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|Baseline to first observation of disease progression or death, 12 weeks up to 31 months|Randomized and treated (RT) population includes all randomized patients. Patients are analyzed according to the treatment they actually received (intent-to-treat [ITT] analysis). Patients were censored from this analysis (8 pemetrexed/cisplatin/gefitinib and 11 pemetrexed/cisplatin).||Months||95% Confidence Interval|Median
147445|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid|Significantly different laboratory values between the two groups in baseline to endpoint changes|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.||micromole/Liter||Standard Deviation|Mean
147446|NCT00408993|Secondary|Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides|Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value, based on first values at scheduled visits.||millimole/Liter||Standard Deviation|Mean
147447|NCT00408993|Secondary|Vital Signs - Blood Pressure|Change from baseline to endpoint in systolic and diastolic blood pressure.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||mm Hg||Standard Error|Least Squares Mean
147448|NCT00408993|Secondary|Vital Signs - Pulse Rate|Change from baseline to endpoint in pulse rate.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||beats per minute||Standard Error|Least Squares Mean
147449|NCT00408993|Secondary|Vital Signs - Weight|Change from baseline to endpoint in body weight.|Baseline and 12 weeks|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||kilograms||Standard Error|Least Squares Mean
147450|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147451|NCT00408993|Secondary|Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)|Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.|over 12 weeks|Number of randomized patients in each treatment arm for each dosing group||participants|||Number
147452|NCT00408993|Secondary|Number of Participants Discontinuing Due to Adverse Events||over 12 weeks|Intention to Treat Analysis. All randomized patients.||participants|||Number
147453|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire – 5 Dimensions (EQ-5D) (US Based Index Score)|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147454|NCT00408993|Secondary|Time Course of Change in Patient Global Impression - Improvement Scale|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|baseline, over 12 weeks|Intention to Treat analysis. Number of randomized patients with at least one non-missing post-baseline data.||units on a scale||Standard Error|Least Squares Mean
147455|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147456|NCT00408993|Secondary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores|Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147457|NCT00408993|Primary|Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 12 weeks|Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147458|NCT00408928|Secondary|Number of Toxicities Related to Bortezomib (VELCADE®)|Observe the toxicities of VELCADE® when administered to recipients of allogeneic hematopoietic stem cell transplant in the setting of steroid refractory or steroid dependent acute graft-versus-host disease.|Through 30 days post-traeatment|||toxicities|||Number
147478|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147459|NCT00408928|Primary|Response to Bortezomib (VELCADE®)|"Response is the primary endpoint of this study and will be scored on day 21 (3 weeks after the first dose of VELCADE) and every 3 weeks subsequently. Patients who progress or expire before the end of the study will be considered non-responders.~Patients are evaluated for response in an organ if they have AGVHD in that organ at the start of treatment with VELCADE or if AGVHD develops after the start of VELCADE, but before the time period of evaluation. Complete response in an organ is defined as no evidence clinical or biochemical signs of AGVHD. For the overall assessment, it is defined as complete resolution of rash, abnormal LFTs, and absence of diarrhea attributed to AGVHD.~Partial response is defined as a one stage decrease in any organ system without worsening in other organ systems."|Through 30 days post-treatment|||participants|||Number
147460|NCT00408902|Secondary|Progression-free Survival|Estimated time to progression using the method of Kaplan and Meier.|Up to 4 weeks after completion of study treatment|Intent to treat||months||Full Range|Median
147461|NCT00408902|Secondary|Overall Survival|Estimated using the method of Kaplan and Meier.|Up to 4 weeks after completion of study treatment||||||
147462|NCT00408902|Primary|Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden)|The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Up to 4 weeks after completion of study treatment|Intent to treat||participants|||Number
147463|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Weight||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||kilograms||Standard Error|Least Squares Mean
147464|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
147465|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||mm Hg||Standard Error|Least Squares Mean
147466|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||beats per minute||Standard Error|Least Squares Mean
147467|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
147468|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
147469|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
147470|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
147471|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
147472|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
147473|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||micromole/Liter||Standard Deviation|Mean
147474|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||millimole/Liter||Standard Deviation|Mean
147475|NCT00408876|Secondary|Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||Units/Liter||Standard Deviation|Mean
147476|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||Units/Liter||Standard Deviation|Mean
147477|NCT00408876|Secondary|Adverse Events Reported as Reason for Discontinuation||Baseline to Week 13|Number of all randomized patients.||participants|||Number
147540|NCT00408681|Secondary|Mucosal Anatomic Response|See prior description|6 to 7 weeks after starting treatment with the study product|||Participants|||Count of Participants
147479|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147480|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147481|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Vitality scores range from 4-24 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147482|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Social functioning scores range from 2-10 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147483|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-physical scores range from 4-8 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147484|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-emotional scores range from 3-6 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147485|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Physical functioning scores range from 10-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147486|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Mental health scores range from 5-30 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147487|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). General health scores range from 5-25(higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147541|NCT00408681|Secondary|Mucosal Anatomic Response|See prior description.|5 weeks after starting treatment with the study product|||Participants|||Count of Participants
147542|NCT00408681|Secondary|Mucosal Anatomic Response|See prior definition|4 weeks after starting treatment with the study product|||Participants|||Count of Participants
147488|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Bodily pain scores range from 2-11 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147489|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147490|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147491|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale|Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147492|NCT00408876|Secondary|Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||participants|||Number
147493|NCT00408876|Secondary|Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward||Baseline to Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||participants|||Number
147494|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147495|NCT00408876|Primary|Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147496|NCT00408876|Primary|Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 12|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147497|NCT00408876|Primary|Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 11|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147498|NCT00408876|Primary|Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 10|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147499|NCT00408876|Primary|Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 9|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147500|NCT00408876|Primary|Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 8|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147969|NCT00405509|Primary|Local Leukotriene Levels|nasal secretions were collected once a day for the first six days of the respiratory infection and on day 30 then measured for leukotriene levels|once a day for 6 days and on day 30|||pg/ml||Standard Deviation|Mean
147503|NCT00408876|Primary|Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 5|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147504|NCT00408876|Primary|Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 4|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147505|NCT00408876|Primary|Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 3|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147506|NCT00408876|Primary|Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 2|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147507|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147508|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147509|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147510|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147511|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147512|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147513|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147514|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147515|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score||Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147516|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147517|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147518|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147519|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score|The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147520|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score|The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147521|NCT00408876|Secondary|Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score|Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147522|NCT00408876|Secondary|Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint|"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from~1 (very much better) to 7 (very much worse)."|Week 13|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Endpoint is the last non-missing measure from Week 4 to Week 13. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
147523|NCT00408876|Primary|Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1|Number of randomized patients with a baseline and at least one non-missing post-baseline value.||units on a scale||Standard Error|Least Squares Mean
147524|NCT00408694|Secondary|One- and Two-year Overall Survival Rates|Estimated using the Kaplan-Meier method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
147525|NCT00408694|Secondary|One- and Two-year Progression-free Survival Rates|Estimated using the Kaplan-Meier method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
147526|NCT00408694|Secondary|One- and Two-year Loco-regional Progression-free Rates|Estimated using the cumulative incidence method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
147527|NCT00408694|Secondary|One- and Two-year Distant Metastases-free Rates|Estimated using the cumulative incidence method. Estimated along with their associated 95% confidence intervals.|From registration to two years.||||||
147528|NCT00408694|Secondary|Death During or Within 30 Days of Discontinuation of Protocol Treatment.||From discontinuation of protocol treatment to 30 days after.||||||
147529|NCT00408694|Secondary|Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen|Estimated using a binomial distribution along with their associated 95% confidence intervals. Evaluated in terms of protocol treatment delivery. Measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with RT and RT scored by the study chair as no variation or minor variation. Tolerability for the adjuvant component will be measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase.|109 From start of treatment to end of treatment (approximately day 109).||||||
147530|NCT00408694|Secondary|Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year.|Estimated using a binomial distribution along with their associated 95% confidence intervals. Graded using the CTCAE version 3.0.|From day 366 to end of follow-up.||||||
147531|NCT00408694|Primary|Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.|Estimated using a binomial distribution along with their associated 95% confidence intervals. Graded using the CTCAE version 3.0.|From start of treatment to one year.|Eligible patients who started study treatment.||participants|||Number
147532|NCT00408681|Other Pre-specified|Agents Added to Treat GVHD More Than 3 Days After Enrollment||Up to 100 days after enrollment|||Participants|||Count of Participants
147533|NCT00408681|Secondary|Causes of Death||up to 6 years after enrollment|||Participants|||Count of Participants
147534|NCT00408681|Secondary|Survival||2 years after enrollment|||Participants|||Count of Participants
147535|NCT00408681|Secondary|Survival||1 year after enrollment|||Participants|||Count of Participants
147536|NCT00408681|Secondary|Survival||6 months after enrollment|||Participants|||Count of Participants
147537|NCT00408681|Secondary|Non-relapse Mortality||2 years after enrollment|||Participants|||Count of Participants
147546|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147547|NCT00408629|Secondary|Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least a 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to questions within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147548|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 32, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147549|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147550|NCT00408629|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"RBS ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147551|NCT00408629|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"SFS ranges from 0-3 as follows:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. The participant served as his/her own control."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147552|NCT00408629|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8|"The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147553|NCT00408629|Secondary|Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Baseline to Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147554|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147555|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 52|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147970|NCT00405288|Post-Hoc|Other Neonatal Health Concerns||neonatal period|||participants|||Number
147556|NCT00408629|Secondary|Proportion of Participants Who Achieved Mucosal Healing at Week 8|"Mucosal healing is defined as an Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease(spontaneous bleeding, ulceration)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147557|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147558|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147559|NCT00408629|Secondary|Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8|"Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147560|NCT00408629|Secondary|Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8, Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission.||Percentage of Participants|||Number
147561|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to OL treatment were considered to be non-remission.||Percentage of Participants|||Number
147562|NCT00408629|Primary|Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|Intent-to-treat (ITT) analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label (OL) treatment were considered to be non-remission.||Percentage of Participants|||Number
147563|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Weight||Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||kilograms||Standard Deviation|Mean
147564|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic|Systolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||mm Hg||Standard Deviation|Mean
147565|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic|Diastolic blood pressure measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||mm Hg||Standard Deviation|Mean
147566|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate|Pulse rate (heart rate) measured in the sitting position.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||beats per minute||Standard Deviation|Mean
147971|NCT00405288|Post-Hoc|Skin Conditions in Neonatal Period||neonatal period|||participants|||Number
147567|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid|Change from baseline to endpoint in uric acid using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||micromole/Liter||Standard Deviation|Mean
147568|NCT00408421|Secondary|Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase|Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||Units/Liter||Standard Deviation|Mean
147569|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147570|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147571|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score|The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147572|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147573|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary|A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147574|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.|Over 13 Weeks|Number of re-randomized patients with non-missing response values.||participants who responded|||Number
147575|NCT00408421|Secondary|Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings|Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||participants who responded|||Number
147576|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147577|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147578|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147579|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147580|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147581|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147582|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147583|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147584|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147585|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147586|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147587|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147972|NCT00405288|Post-Hoc|Neonatal Health Concerns-infections|Infections occuring in the neonatal period|neonatal period|||participants|||Number
147588|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147589|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis in the re-randomized patients. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147590|NCT00408421|Secondary|Weekly Change From Baseline in the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
147591|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147592|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147593|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147594|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147595|NCT00408421|Secondary|Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).|Baseline and 13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Deviation|Mean
147596|NCT00408421|Secondary|Patient Global Impression of Improvement at 13 Week Endpoint|A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).|13 Weeks|Analysis was conducted on an intent-to-treat basis. Missing data were imputed using a Last Observation Carried Forward approach. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific for the specific outcome measure were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
147597|NCT00408421|Primary|Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary|This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).|Over 13 Weeks|Analyses were conducted on an intent-to-treat basis. All randomized patients with a baseline and at least one non-missing post-baseline value for the specific outcome measure were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
147613|NCT00407797|Secondary|Treatment Satisfaction: Patient General Impression to Change (PGIC)|Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.||percent of participants|||Number
147973|NCT00405288|Post-Hoc|Respiratory Neonatal Health Concerns||neonatal period|||participants|||Number
147598|NCT00408317|Other Pre-specified|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft or watery stool. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency on Day 4 for the first treatment period and second treatment period period for total participants was summarized.|Day 4 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||percentage of stools||Standard Deviation|Mean
147599|NCT00408317|Other Pre-specified|Number of Bowel Movements|Number of bowel movements of each participant was calculated from frequency of stools by the participant per day. Mean daily number of bowel movements on Day 3 for the first treatment period and second treatment period was summarized.|Day 3 on first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||bowel movements||Standard Deviation|Mean
147600|NCT00408317|Secondary|Percent Coefficient of Nitrogen Absorption (CNA)|Percent (%) CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Nitrogen intake was calculated as protein intake/6.25. Mean percent CNA was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||Percent CNA||Standard Deviation|Mean
147601|NCT00408317|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent (%) CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.|Day 3 to Day 7 in first intervention period and second intervention period|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluated for this outcome measure.||Percent CFA||Standard Deviation|Mean
147602|NCT00408200|Secondary|Freedom From Atrial Arrhythmia at 6 Months Post Procedure.||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.||participants|||Number
147603|NCT00408200|Primary|Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug||6 weeks|Assuming an incidence of the composite primary end point of 40% in the control group and a 50% reduction in the composite primary end point in the drug treatment group, we calculated that 160 patients would have to be included in the study in order to obtain a power of 80% and with a 2-tailed error of 0.05.||participants|||Number
147604|NCT00408070|Secondary|Determine Tolerability to 12 Months (q 3 Weeks) of Bevacizumab Maintenance Therapy||12 months||||||
147605|NCT00408070|Secondary|To Determine the Degree and Type of Toxicity of This Combined Regimen||weekly||||||
147606|NCT00408070|Secondary|Rate of Decline of CA-125||not assessed; study terminated early||||||
147607|NCT00408070|Secondary|Response to Treatment (Clinical/Pathological)||not assessed; study terminated early||||||
147608|NCT00408070|Primary|Progression Free Survival Rate at 9 Months|This Outcome is measuring the number of particpants who have survived.|9 months|||participants|||Number
147609|NCT00407966|Primary|Complete Response|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an Absolute Neutrophil Count of at least 1000/mililiter and a platelet count of 100,000 mililiter, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A complete remission must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the complete remission.|6 months|Total number of participants entered between December 2006 and June 2008||participants|||Number
147610|NCT00407797|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.||scores on scale||Standard Deviation|Mean
147611|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale|Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b.|Week 21, LOCF|FAS. LOCF=Last Observation Carried Forward.||scores on scale||Standard Deviation|Mean
147612|NCT00407797|Secondary|Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)|Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.|Week 21, LOCF|FAS. LOCF = Last Observation Carried Forward.||scores on scale||Standard Deviation|Mean
147614|NCT00407797|Secondary|Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
147615|NCT00407797|Secondary|Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period||Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
147616|NCT00407797|Secondary|Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period|Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).|Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
147617|NCT00407797|Secondary|Percent of Seizure- Free Participants During the Treatment Observation Period|Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).|Week 9 to Week 21 or Early Termination (end of treatment)|FAS. N=number of subjects with evaluable data.||percent of participants|||Number
147618|NCT00407797|Secondary|Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period|Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.||percent change||Standard Deviation|Mean
147619|NCT00407797|Secondary|Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21|Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.|Week 21 or End of Treatment (early termination)|FAS.||percent change||Standard Deviation|Mean
147620|NCT00407797|Secondary|Response Ratio (RR)|Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.|Week 9 to Week 21 or End of Treatment (early termination)|FAS. N=number of subjects with evaluable data.||ratio||Standard Deviation|Mean
147621|NCT00407797|Primary|Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase|28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.|Week 9 to Week 21 or End of Treatment (early termination)|Full Analysis Set (FAS): all subjects who received at least 1 dose of assigned treatment, had valid baseline seizure data, and had at least 1 subsequent rating of seizure frequency (modified intent to treat population). N=number of subjects with evaluable data.||percent change||Standard Deviation|Mean
147622|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147623|NCT00407745|Secondary|Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147624|NCT00407745|Secondary|Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
147625|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147648|NCT00407745|Other Pre-specified|Change From Baseline in Weekly Mean Sleep Interference Score by Week|Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 1 through 16|ITT; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147974|NCT00405288|Post-Hoc|Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth|Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth|neonatal period|||participants|||Number
147626|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147627|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147628|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147629|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147630|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147631|NCT00407745|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index|Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147632|NCT00407745|Secondary|Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)|NPSI – Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
147633|NCT00407745|Secondary|Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)|NPSI – Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline.|Baseline, Week 16|MITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
147634|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147635|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147636|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147637|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147638|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147639|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF;(n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147640|NCT00407745|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score|Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147641|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales|Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147642|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147643|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli|Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147644|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia|Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147645|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147646|NCT00407745|Secondary|Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia|Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147647|NCT00407745|Secondary|Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score|The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from “does not interfere” (0) to “completely interferes” (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale.|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147649|NCT00407745|Secondary|Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
147650|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score by Week|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 1 through16|ITT population: defined as all randomized participants who took at least one dose of study medication. (This population included the 8 participants who were randomized before the protocol amendment 2). (n) = number of participants with data for analysis.||score on scale||Standard Deviation|Mean
147651|NCT00407745|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]).|Baseline, Week 16|mITT; LOCF; (n) = number of participants with data available for analysis||score on scale||Standard Deviation|Mean
147652|NCT00407745|Secondary|Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)|The PGIC is a participant-rated instrument measuring change in the participant’s overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline, Week 16|mITT; LOCF; (N) = number of participants with data available for analysis||participants|||Number
147653|NCT00407745|Secondary|Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; LOCF: LOCF Endpoint corresponded to the last 7 days of diary data up to and including Week 16 and applied if the Week 16 assessment was missing; (N) = number of participants that can be analyzed for the endpoint.||participants|||Number
147654|NCT00407745|Secondary|Change From Baseline in Weekly Mean Pain Score|Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Baseline, Week 16|mITT; modified baseline observation carried forward (mBOCF) imputation: mBOCF mean pain score was defined as the baseline mean pain score for participants who discontinued double-blind treatment due to adverse event or who had no postbaseline observations and as the last observation carried forward (LOCF) mean pain score for all other participants.||score on scale||Standard Deviation|Mean
147655|NCT00407745|Primary|Duration Adjusted Average Change (DAAC) of Mean Pain Score|DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.|Baseline, Week 16|mITT: all randomized participants who received at least one dose of study medication except the 8 participants who were randomized before protocol amendment 2.||score on scale||Standard Error|Least Squares Mean
147656|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-treated Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;~Stable disease for atleast 16 weeks"|Up to 6 years|||participants|||Number
147657|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used (Bevacizumab-treated Group)|12 months|||months||95% Confidence Interval|Median
147658|NCT00407654|Secondary|Overall Survival (Bevacizumab-treated Group)|Kaplan-Meier method will be used. (Bevacizumab-treated Group)|6 months|||months||95% Confidence Interval|Median
147659|NCT00407654|Primary|Progression-free Survival (Bevacizumab-treated Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~Kaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)"|4 months|||months||95% Confidence Interval|Median
147660|NCT00407654|Secondary|Number of Participants With Response (Bevacizumab-naïve Group)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD;~Stable disease for atleast 16 weeks"|Up to 6 years|||participants|||Number
147661|NCT00407654|Secondary|Objective Stable Disease Rate||Up to 6 years||||||
147662|NCT00407654|Secondary|Time to Progression|Kaplan-Meier method will be used.|12 months||||||
147663|NCT00407654|Secondary|Overall Survival (Prior Bevacizumab Treated Group)|Kaplan-Meier method will be used (Bevacizumab-naïve Group)|12 months|||months||95% Confidence Interval|Median
147664|NCT00407654|Secondary|Overall Survival (Bevacizumab-naïve Group)|Kaplan-Meier method will be used. (Bevacizumab- naïve Group)|12 months|||months||95% Confidence Interval|Median
147665|NCT00407654|Primary|Progression-free Survival (Bevacizumab- naïve Group)|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions~Kaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)"|4 months|||months||95% Confidence Interval|Median
147666|NCT00407654|Primary|Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 6 years|||participants|||Number
147683|NCT00407537|Secondary|Mean Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||Standard Deviation|Mean
147667|NCT00407563|Secondary|Best Overall Response at Six Months|The outcome measure assessed the percentage of participants who had achieved either a Partial or Complete Response over 6 months of treatment. Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Assessed over 6 months of study treatment|The 2 tailed, 95% confidence interval of the estimated response rate was calculated using the normal approximation to the binomial distribution.||percentage of patients||95% Confidence Interval|Number
147668|NCT00407563|Secondary|Progression-free Survival (PFS)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed every 12 weeks) or death, whichever came first, assessed up to 30 months.|Participants who had not experienced either disease progression or death during or after stopping treatment were censored in the analysis.||Months||95% Confidence Interval|Median
147669|NCT00407563|Secondary|Overall Survival||Overall survival is defined as the time from treatment start until death from any cause, assessed up to 40 months.|Participants who had not experienced death during or after stopping treatment were censored in the analysis.||Months||95% Confidence Interval|Median
147670|NCT00407563|Secondary|Best Overall Response|Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR+PR.|Radiologic imaging was repeated after every 3 cycles (about every 12 weeks) during study treatment, up to 31 months.|||Participants|||Number
147671|NCT00407563|Primary|6-month Progression-Free Rate|Progression-free rate is defined as the percentage of participants with no progression event at 6 months after starting study treatment. An event for this endpoint was defined as a progression-free survival event occurring earlier than six months, or discontinuation of treatment earlier than six months for any other reason. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|6 months after initiation of study treatment|||percentage of patients||95% Confidence Interval|Number
147672|NCT00407550|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 4 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years)||||||
147673|NCT00407550|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Death or last follow-up (up to 2 years)||||||
147674|NCT00407550|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 2 years)||||||
147675|NCT00407550|Primary|Number of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~>~> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart (up to 2 years)|||participants|||Number
147676|NCT00407537|Secondary|Number of Participants With Increase of Treatment Dosages After 4 Months.|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||Participants|||Number
147677|NCT00407537|Secondary|Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months|Treatments indicative of prescribed medications other than study provided Caduet.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||participants|||Number
147678|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months|Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||Percentage of participants|||Number
147679|NCT00407537|Secondary|Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months|Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.|Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||percentage of participants|||Number
147680|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||95% Confidence Interval|Least Squares Mean
147681|NCT00407537|Secondary|Change From Baseline in Lipid Parameters at Month 4|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||95% Confidence Interval|Least Squares Mean
147682|NCT00407537|Secondary|Mean Lipid Parameters at Month 12|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.|Month 12|FAS. Number of participants analyzed refers to number of participants contributing data.||mg/dL||Standard Deviation|Mean
147690|NCT00407537|Secondary|Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||95% Confidence Interval|Least Squares Mean
147691|NCT00407537|Secondary|Change From Baseline in Framingham 10-year Risk of Developing Total CHD|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.|Baseline, Month 4, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||95% Confidence Interval|Least Squares Mean
147692|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 4|Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
147693|NCT00407537|Secondary|Framingham 10-year Risk of Stroke at Month 12|Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific “calibration factor” for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
147694|NCT00407537|Secondary|European SCORE 10-year Risk of Fatal CVD at Month 4|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 4 months of study treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
147695|NCT00407537|Secondary|European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12|European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).|Baseline, Month 12|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
147696|NCT00407537|Secondary|Framingham 10-year Risk of Total CHD at Month 4|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).|Baseline, Month 4|FAS. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
147697|NCT00407537|Primary|Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12|Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).|Baseline, Month 12|Full Analysis Set (FAS) included all subjects, in either treatment group, who had blood pressure and lipid data from at least 1 follow-up visit. Number of participants analyzed refers to number of participants contributing to data.||percent risk||Standard Deviation|Mean
147698|NCT00407511|Secondary|Clinical Global Impression of Change (CGIC)|7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)||participants|||Number
147699|NCT00407511|Secondary|Patient Global Impression of Change (PGIC)|7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)|End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)|Full Analysis Set (FAS)||participants|||Number
147700|NCT00407511|Secondary|Change From Baseline in Mean Daily Sleep Interference Score (DSIS)|Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
147701|NCT00407511|Secondary|Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)|100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
147702|NCT00407511|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)|100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
147910|NCT00405938|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval, in months, from the date of first treatment to the date of disease progression or death, whichever occurred first.|18 months|||months||95% Confidence Interval|Median
147703|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.||scores on scale||Standard Deviation|Mean
147704|NCT00407511|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.||scores on scale||Standard Deviation|Mean
147705|NCT00407511|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores|Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.|Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
147706|NCT00407511|Secondary|Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.|Baseline, Week 8, Week 12, EOT/LOCF|Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.||scores on scale||Standard Deviation|Mean
147707|NCT00407511|Secondary|Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.|Week 4, Week 8, Week 12|Full Analysis Set (FAS).||scores on scale||Standard Deviation|Mean
147708|NCT00407511|Primary|Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)|11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.|Baseline, End of Treatment|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).||scores on scale||Standard Deviation|Mean
147709|NCT00407485|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions PFS using the product-limit method of Kaplan and Meier.|From start of treatment to time of progression, assessed up to 4 months|||Months||95% Confidence Interval|Median
147710|NCT00407485|Primary|Tumor Response Rate|"Response rate (RR) and progression free survival (PFS) were assessed in a 2-stage accrual design (22+18). A maximum of 40 patients were to be accrued to rule out a null hypothesized RR of 4% and PFS of 3 months versus alternative of 15% RR and 5.4 months PFS (corresponding to 4 month PFS of 40% vs 60%) with α=0.12 and β=0.19. If no more than 1 objective response (no more than 4.5%), and no more than 10 instances of 4-month PFS (no more than 45%), were observed among the initial 22 patients, the study would be terminated early and declared negative. Tumor response was evaluated by CT or MRI using RECIST v1.0 criteria.~Responders were confirmed partial or complete responses to treatment."|From the start of the treatment until disease progression or recurrence, assessed up to 4 years|||percentage of responders||95% Confidence Interval|Number
147711|NCT00407355|Primary|Retinal Thickness Change From Baseline at All Visits||continuous through 72 mos|||microns||Standard Deviation|Mean
147712|NCT00407355|Primary|Best Corrected Visual Acuity Change From Baseline at All Visits||continuous through 72 mos|||ETDRS letters||Standard Deviation|Mean
147713|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Error|Least Squares Mean
147724|NCT00406848|Secondary|Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count|The number of participants with abnormal laboratory values at any time during the study period. Results are reported for laboratory analytes that exhibited statistically significantly different proportions of participants who had abnormal values between treatment groups. Statistical significance was considered at the 0.05 level. The lower limit of normal for leukocyte count is 3.8 Billion/Liter. Participants who had a value below that number were considered to have abnormally low leukocyte count.|baseline (Week 1) through Week 13|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.||participants|||Number
147714|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Error|Least Squares Mean
147715|NCT00407030|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to 20 weeks after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect"||points on a scale||Standard Deviation|Mean
147716|NCT00407030|Secondary|Change From Baseline in the TWSTRS Pain Subscore|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
147717|NCT00407030|Secondary|Change From Baseline in the TWSTRS Severity Subscore|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
147718|NCT00407030|Secondary|Change From Baseline in the TWSTRS Disability Subscore|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
147719|NCT00407030|Secondary|Change From Baseline in the TWSTRS-Total Score|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)|Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Deviation|Mean
147720|NCT00407030|Primary|Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 4|Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value||points on a scale||Standard Error|Least Squares Mean
147721|NCT00406848|Secondary|Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores|The cognitive assessment battery is composed of four tests: Verbal Learning (score 0-15)and Delayed Recall(score 0-15) test, SDST(Score 0-133),2DCT(score 0-40),Trail Making(Part B)(score 0-180).They are designed to challenge the patient's abilities in the following areas: verbal learning and memory; attention to visually presented material; and working memory and executive function. Composite Cognitive score(0-51)is derived from normalized individual test scores. For Trail Making Test,lower number indicates better cognition. For all other test scores,higher number indicates better cognition.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147722|NCT00406848|Secondary|Number of Participants With Successful Treatment Outcome|Successful treatment outcome defined as: Participant completed the study and being in remission (HAMD-17 Total score ≤7 and ≤10) at least for the last two visits (4 weeks)of the study. The HAMD-17 is used to assess the severity of depression. The total score ranges from 0 (not at all depressed) to 52 (severely depressed).|Baseline (Week 1) through Week 25|All participants randomized under protocol amendment c,d,e, and that have non-missing successful treatment values.||participants|||Number
147723|NCT00406848|Secondary|Change From Baseline in Electrocardiograms|The Electrocardiogram measures include the following time intervals: QT interval, QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF), QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB), PR interval and QRS interval.|baseline (Week 1), Week 25|Participants with a baseline and at least one non-missing post baseline value.||millisecond (msec)||Standard Error|Least Squares Mean
147725|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Chloride and Fasting Glucose|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||millimole/liter||Standard Deviation|Mean
147726|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC)|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||Micromole/liter (Fe)||Standard Deviation|Mean
147727|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Erythrocyte Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||Trillion/Liter||Standard Deviation|Mean
147728|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Uric Acid|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||micromole/liter||Standard Deviation|Mean
147729|NCT00406848|Secondary|Change From Baseline in Laboratory Values - Platelet Count|Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.|baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one post-baseline value in each treatment group.||billions per liter (bill/L)||Standard Deviation|Mean
147730|NCT00406848|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation|Adverse Events and Serious Adverse Events leading to study discontinuation.|baseline (Week 1) through Week 25|All randomized patients.||participants|||Number
147731|NCT00406848|Secondary|Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH)|Sustained Hypertension is defined as supine systolic BP >= 140 (or diastolic BP >= 90) mm Hg and increase from baseline (highest value in baseline visit interval) >= 10 mm Hg for 3 or more consecutive visits in postbaseline visit interval. Orthostatic Hypotension is defined as standing diastolic BP at least 10 mm Hg less than the supine diastolic BP or the standing systolic BP at least 20 mm Hg less than the supine systolic BP at any time in postbaseline visit interval and a patient does not meet this criterion at any visit in baseline interval.|baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.||Participants|||Number
147732|NCT00406848|Secondary|Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study|"A patient has a treatment-emergent elevated supine systolic blood pressure if the value is ≥140 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine diastolic blood pressure if the value is ≥90 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine pulse if the value is ≥100 with an increase ≥10 from baseline.~A patient has abnormal weight change if the gain or loss is ≥7% compared to baseline."|Baseline (Week 1) through Week 25|All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.||Participants|||Number
147733|NCT00406848|Secondary|Change From Baseline in Weight||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.||kilograms (kg)||Standard Error|Least Squares Mean
147734|NCT00406848|Secondary|Change From Baseline in Pulse Rate||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.||beats per minute (bpm)||Standard Error|Least Squares Mean
147735|NCT00406848|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||baseline (Week 1), Week 13, Week 25|All randomized patients with a baseline and at least one non-missing post-baseline value.||mmHg||Standard Error|Least Squares Mean
147736|NCT00406848|Secondary|Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3|Patients are considered to have met onset (visitwise binary outcome, yes/no) criteria at a particular visit if they had at least 20% reduction from baseline in the HAMD-17 Maier subscale at that visit and at all subsequent visits in the acute phase. Maier subscale measures core symptoms of depression and scores range from 0 (normal) to 24 (severe). The visitwise probability of patients meeting onset criteria was analyzed using a categorical, pseudo-likelihood-based repeated measures approach.|Week 3|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||Probability of onset||Standard Error|Least Squares Mean
147737|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G)|Remission defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. Total score ranges: 0 (normal) to 52 (severe depression). Visitwise probability of patients achieving remission was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. CIRS-G evaluates 14 organ-specific categories using a rating strategy of 0=no problems; 1=current mild problem/past significant problem; 2=moderate disability/morbidity; 3=severe/constant significant disability; and 4=extremely severe/immediate treatment required/end organ failure. Total score ranges: 0 to 56.|Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.||probability of remission||Standard Error|Least Squares Mean
147738|NCT00406848|Secondary|Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score|Response (visitwise binary outcome, yes/no) is defined as ≥ 50% reduction from baseline in the HAMD-17 total score. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for response was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||probability of response||Standard Error|Least Squares Mean
147975|NCT00405288|Secondary|Neonatal Health|Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth|at birth|||participants|||Number
147739|NCT00406848|Secondary|Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10|Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||probability of remission||Standard Error|Least Squares Mean
147740|NCT00406848|Secondary|Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147741|NCT00406848|Secondary|Change From Baseline in the Mini-Mental State Exam (MMSE)|Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia.|baseline (Week 1), Week 9, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147742|NCT00406848|Secondary|Change From Baseline in the Clinical Global Impression-Severity (CGI-S)|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147743|NCT00406848|Secondary|Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks|The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “very much improved,” a score of 4 indicates that the patient has experienced “no change,” and a score of 7 indicates that the patient is “very much worse.”|Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147744|NCT00406848|Secondary|Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores|Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147745|NCT00406848|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores|The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147746|NCT00406848|Secondary|Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items|Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms.|baseline (Week 1), Week 13, Week 25|Randomized patients with non-missing data at baseline and post-baseline visit.||units on a scale||Standard Error|Least Squares Mean
147747|NCT00406848|Secondary|Change From Baseline on the 30-item Geriatric Depression Scale (GDS)|The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression).|baseline (Week 1), Week 13, Week 25|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147748|NCT00406848|Primary|Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).|baseline (Week 1), Week 13|All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.||units on a scale||Standard Error|Least Squares Mean
147749|NCT00406783|Other Pre-specified|Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|Baseline|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.||scores on a scale||Standard Error|Least Squares Mean
147750|NCT00406783|Other Pre-specified|Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|Baseline|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.||scores on a scale||Standard Error|Least Squares Mean
147751|NCT00406783|Secondary|Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit|The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.|15 days|Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects >=18 years of age and where available in the local language.||scores on a scale||Standard Error|Least Squares Mean
147752|NCT00406783|Primary|The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15|AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).|15 days|Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.||scores on a scale||Standard Error|Least Squares Mean
147753|NCT00406718|Secondary|Schizophrenia Symptoms|Brief Psychiatric Rating Scale (BPRS) expanded version psychosis subscale, mean of items for unusual thought content, auspiciousness, conceptual disorganization, and hallucinations. Higher scores mean greater level of symptomatology. Scores vary from 1 = absent to 7 = severe|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All subjects with a baseline and at least one follow up rating||units on a scale||Standard Deviation|Mean
147754|NCT00406718|Primary|Social and Occupational Functioning Assessment Scale (SOFAS) Scores|Scale from 1-100 rating global social and occupational functioning. Higher scores indicate better functional outcomes|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|Patients with baseline and at least one follow up rating||Units on a scale||Standard Deviation|Mean
147755|NCT00406718|Primary|Adherence|Adherence derived from electronic monitoring. Percentage of medication taken during each preceding 3 month period, averaged across treatment period.|Measured at Months 4, 7, and 10 months averaged across the treatment period which began 1 month after study baseline and ended at month 10 (total 9 mos of treatment)|All individuals randomized who had a baseline and at least one follow-up rating||Percentage of medication taken||Standard Deviation|Mean
147756|NCT00406692|Secondary|Symbol Digit Modalities Test (DSMT)|Number of correct digit substitutions on the DSMT per session with the possible maximum score being 188. The value shown is for difference between mean scores obtained for baseline and week 12 sessions.|Baseline, Week 12|ITT||Units on a scale||Standard Error|Mean
147757|NCT00406692|Primary|Difference in Mean Words for the Phonetic Portion of the Controlled Word Association Test (COWAT).|Subjects were asked to generate as many words as possible starting with a particular letter over a 60 second period. Three letters were used for each sessions. Values shown are the differences between values obtained for the baseline and week 12 test session.|Week 0- Baseline and Week 12|ITT||Number of Words||Standard Error|Mean
147758|NCT00406692|Primary|The Weekly Mean Number of Standard Drinks Consumed Per Day at Baseline and Treatment Phase|The mean daily standard alcoholic drinks were determined for the baseline period and each treatment week as a measure of alcohol intake. One standard drink=14g of alcohol. Mean value is the difference between mean standard drinks for the baseline period and week 12 of the study.|Baseline and Week 12|ITT||Standard Drinks||Standard Error|Mean
147759|NCT00406653|Secondary|OL; Number of Participants With Pharmacogenomic Marker Activity|Changes in the expression of individual ribonucleic acid (RNA) transcripts were to be evaluated from whole blood using both microarray transcriptional profiling and quantitative polymerase chain reaction (PCR) methods. Peripheral RNA transcriptional profiling was to be used only to identify individual RNA transcripts that differ in expression with respect to time, treatment and outcome.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of pharmacogenomic marker activity in participants was not conducted for the OL as planned.||participants|||Number
147760|NCT00406653|Secondary|OL; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.||participants|||Number
147761|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.||participants|||Number
147762|NCT00406653|Secondary|OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day OL-169|All Randomized and Treated (receiving ≥1 infusion) Participants in Open-Label Extension Period.||participants|||Number
147763|NCT00406653|Secondary|OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy|Background corticosteroid therapy included prednisone or budesonide.|Between Day OL-1 and Day OL-617|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis of corticosteroid use in participants was not conducted for the OL as planned.||participants|||Number
147764|NCT00406653|Secondary|MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical remission in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||participants|||Number
147765|NCT00406653|Secondary|MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint subgroup analysis of clinical response in participants who have had an inadequate response and/or intolerance to anti-TNF therapy was not conducted for the MP as planned.||participants|||Number
147766|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among Participants Who Received Baseline Corticosteroid Therapy and Who Achieved CDAI-Defined Clinical Remission|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score is based partly on entries from participant’s Diary (7 days before evaluation) which is kept while on study. CDAI scores range from 0 to ~600. Clinical response=CDAI reduction ≥100 or absolute CDAI <150. Clinical remission=CDAI <150. Moderate to severe disease=CDAI ≥220 and ≤450.|Day MP-365|On/after Day MP-1, a defined tapering of corticosteroids was planned if the participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned.||participants|||Number
147767|NCT00406653|Secondary|MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy|Participants who received corticosteroid therapy (e.g. prednisone or budesonide) were to maintain a stable dose until Day MP-1. On or after Day MP-1, a recommended tapering regimen of corticosteroid therapy was planned if the participant was in remission (i.e., CDAI score < 150), or if the participant’s condition had satisfactorily improved according to investigators clinical assessment. Other CD therapy was to remain at a stable dose throughout the Maintenance Period, with the exception of decreases due to drug-related toxicities.|Day MP-365|On/after Day MP-1, a recommended tapering of corticosteroids was planned if participant was in remission/had improved. Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analyses for corticosteroid sparing were not conducted for the MP as planned||participants|||Number
147768|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in IBDQ responses were not conducted for the MP as planned.||units on a scale||Standard Deviation|Mean
147798|NCT00406640|Secondary|Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||Percentage of patients|||Number
147769|NCT00406653|Secondary|MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day MP-365|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for changes from baseline in SF-36 responses were not conducted for the MP as planned.||units on a scale||Standard Deviation|Mean
147770|NCT00406653|Secondary|MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-169|Due to the early termination of the study after the IP results were reviewed and the primary efficacy endpoint was not achieved, the secondary endpoint analysis for the cohort of participants with clinical remission at both Day MP-169 and Day MP-365 was not conducted for the MP as planned.||participants|||Number
147771|NCT00406653|Primary|OL; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population)||participants|||Number
147772|NCT00406653|Secondary|MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
147773|NCT00406653|Secondary|MP; Number of Participants With Positive Antibody Response to Abatacept|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants not entering OL: All measurements after Day MP-1 (including follow-up visits); For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population. The placebo group was constituted by participants who received abatacept in the IP and underwent drug withdrawal in the MP.||participants|||Number
147774|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs) of Special Interest:|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the MP, based on a participant’s received treatment (As Treated Analysis Population)||participants|||Number
147775|NCT00406653|Secondary|MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day IP-85 and Day MP-365|All participants who received at least 1 infusion of study medication during the Maintenance Period, based on a participant’s received treatment (As Treated Analysis Population)||Participants|||Number
147799|NCT00406640|Secondary|Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||percentage of patients|||Number
147776|NCT00406653|Secondary|IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
147777|NCT00406653|Secondary|IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
147778|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|Participants in the All Randomized and Treated (receiving ≥1 infusion) Population who in the past had an inadequate response to, or who were intolerant to, an approved anti-TNF agent at an approved labeled dose for at least 8 weeks. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
147779|NCT00406653|Secondary|IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)|A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition identified specific anti-ABA reactivity. Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig) category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85); For participants treated in OL directly after IP: Day IP-1 to Day OL-1; For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)|All participants who received abatacept and for whom baseline and at least 1 additional measurement were available were included in the Immunogenicity Analysis Population.||participants|||Number
147780|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs) of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the IP, based on a participant’s received treatment (As Treated Analysis Population)||participants|||Number
147781|NCT00406653|Secondary|IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day IP-1 through Day IP-85|All participants who received at least 1 infusion of study medication during the Induction Period, based on a participant’s received treatment (As Treated Analysis Population)||Participants|||Number
147782|NCT00406653|Secondary|IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)|The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-Baseline - Baseline value.|Baseline, Day IP-85|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period with both Baseline and post-Baseline measurements.||units on a scale||Standard Deviation|Mean
147783|NCT00406653|Secondary|IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period||participants|||Number
147784|NCT00406653|Secondary|IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period||participants|||Number
147785|NCT00406653|Primary|Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Between Day OL-1 and Day OL-617|All participants who received at least 1 infusion of open-label study medication at any time, based on a participant’s received treatment (As Treated Analysis Population). The OL was not sized based on power considerations.||participants|||Number
147786|NCT00406653|Primary|Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|Day MP-365 (12 months) of maintenance therapy|All Randomized and Treated (receiving ≥1 infusion) Participants in Maintenance Period. The Maintenance Period was not sized based on power considerations, and thus, no formal statistical hypothesis testing was performed.||participants|||Number
147787|NCT00406653|Primary|Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85|CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI ≥220 and ≤450 points.|At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).|All Randomized and Treated (receiving ≥1 infusion) Participants in Induction Period. Due to site non-compliance with the study protocol, 1 randomized and treated participant from Site 166 was excluded.||participants|||Number
147788|NCT00406640|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper.|6 months|Safety population: Randomized patients who took ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with < 4 wks therapy. Patients analyzed varied by time (DVS SR, ESC): End of Therapy (n=264, 267); Taper week 1 (n=217, 227); Taper week 2 (n=222, 223); Post-taper (n=219, 223).||units on scale||Standard Deviation|Mean
147789|NCT00406640|Secondary|Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase|Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.||Percentage of Non-Responders|||Number
147800|NCT00406640|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17.|Baseline and 8 weeks|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
147790|NCT00406640|Secondary|Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase|Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients who took at least 1 dose of study drug, who did not achieve a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8), entered into the open label extension phase and had baseline and at least 1 post-baseline HAM-D17 evaluation in the acute and open label phase.||Percentage of Non-Responders|||Number
147791|NCT00406640|Secondary|Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase|Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with baseline HAM-D17 score ≥18, who took ≥1 dose study drug, had ≥1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) but not remission (HAM-D17 score ≤ 7) at the end of the acute phase and continued treatment in the 6-month DB continuation phase.||percentage of responders|||Number
147792|NCT00406640|Secondary|Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.||percentage of responders|||Number
147793|NCT00406640|Secondary|Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)|Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50.|6 months|All randomized patients with a baseline HAM-D17 score ≥18, who took at least 1 dose of study drug, had at least 1 post-baseline HAM-D17 evaluation, achieved a response to treatment (≥50% reduction of HAM-D17 total score from baseline) at the end of the acute phase (week 8) and continued treatment in the double blind continuation phase.||percentage of responders|||Number
147794|NCT00406640|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline and week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
147795|NCT00406640|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score.|Baseline and Week 8|Acute Double-blind phase; all randomized patients with a baseline HAM-D17 score ≥ 18, who took at least 1 dose of study drug and had at least 1 post-baseline HAM-D17 evaluation.||units on scale||Standard Deviation|Mean
147796|NCT00406640|Secondary|Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week|CGI-S is a global rating scale that measures the severity of a patient’s disease. Using a 7-point scale, the clinician rates the severity of the patient’s mental illness at the time of the assessment, relative to the clinician’s experience with patients who have the same diagnosis (1= normal; 7= extremely ill).|Baseline and 8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
147797|NCT00406640|Secondary|Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Acute double-blind phase; all randomized patients with a baseline HAM-D17 score ≥18, took at least1 dose of study drug and had at least1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
147801|NCT00406393|Secondary|Time to Discharge After Transplant||Measured at Year 2|Insufficient data to report on this outcome measure|||||
147802|NCT00406393|Secondary|Infections||Measured at Year 2|Insufficient data to report on this outcome measure|||||
147803|NCT00406393|Secondary|Overall Survival||Measured at Year 2|||percentage of participants||95% Confidence Interval|Number
147804|NCT00406393|Secondary|Malignant Disease Relapse|Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, MDS or CMML consistent with pre-transplant features.|Measured at Year 2|||percentage of participants||95% Confidence Interval|Number
147805|NCT00406393|Secondary|Treatment-related Mortality||Measured at Day 100 and Year 2|||percentage of participants||95% Confidence Interval|Number
147806|NCT00406393|Secondary|Reactivation of Cytomegalovirus (CMV) Infection||Measured at Year 2|||percentage of participants||95% Confidence Interval|Number
147807|NCT00406393|Secondary|Thrombotic Microangiopathy (TMA) Infection|The occurrence of TMA within the first 100 days after stem cell transplantation will be recorded. The first day of onset will be used for reporting purposes.|Measured through Day 100|||percentage of participants||95% Confidence Interval|Number
147808|NCT00406393|Secondary|Rate of Veno-occlusive Disease (VOD)|VOD will be defined as the occurrence of VOD (based on the Baltimore Criteria for the diagnosis of VOD) in conjunction with other end-organ dysfunction.|Measured through Day 100|||percentage of participants||95% Confidence Interval|Number
147809|NCT00406393|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 represents severe mucosa.|Measured at Day 21|||units on a scale||Standard Deviation|Mean
147810|NCT00406393|Secondary|Time to Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an Absolute Neutrophil Count (ANC) > 500/mcL for three consecutive measurements on different days. Platelet engraftment is defined as a platelet count > 20,000/mcL for three consecutive measurements over three or more days.|Measured through Day 100|||days||Full Range|Median
147811|NCT00406393|Secondary|Incidence of Acute GVHD|Cumulative incidence of acute GVHD (grade II-IV) occurring 100 days from transplantation.|Measured at Day 100|||percentage of participants||95% Confidence Interval|Number
147812|NCT00406393|Primary|Rate of Grades II-IV Acute GVHD-free Survival|The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.|Day 114|||percentage of participants||95% Confidence Interval|Number
147813|NCT00406367|Secondary|Patient Evaluation of Global Response (PEGR) at Final Visit|"The PEGR is a descriptive subjective 9-point response scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4)."|Final visit (up to week 20 after injection of the Main Period)|"Intention to treat population with missing values imputed by no effect."||Points on a scale||Standard Deviation|Mean
147814|NCT00406367|Secondary|Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection|The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values||Points on a scale||Standard Deviation|Mean
147815|NCT00406367|Secondary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:~JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)~JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values||Points on a scale||Standard Deviation|Mean
147816|NCT00406367|Primary|Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater)|"The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale:~JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity)~JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, week 6|Intention to treat population: all participants randomized were included in the primary efficacy analysis; Last Observation Carried Forward (LOCF) imputation technique used for missing values||Points on a scale||Standard Error|Least Squares Mean
147817|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|9 weeks|All randomized participants who received at least one dose of study drug.||participants|||Number
147818|NCT00406354|Secondary|Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment|Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event.|3 weeks|All randomized participants who received at least one dose of study drug.||participants|||Number
147819|NCT00406354|Secondary|Number of Participants Discontinuing Treatment|Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here.|9 weeks|All participants randomized and receiving at least one dose of study drug.||participants|||Number
147820|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147821|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147822|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147823|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147824|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147825|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147826|NCT00406354|Secondary|German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score|"KINDL-R (Revidierter KINDer Lebensqualitatsfragebogen, revised version), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147827|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores|The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147828|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ODD Score|The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147829|NCT00406354|Secondary|Clinical Global Impressions - Severity (CGI-S): ADHD Score|The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147853|NCT00406315|Primary|Change From Baseline in Weight at Week 16|Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.|Baseline, Week 16, Week 16 LOCF|Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||kilogram||Standard Deviation|Mean
147830|NCT00406354|Secondary|Impact on Family Scale (FaBel), Total Impact Score|Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147831|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147832|NCT00406354|Secondary|Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score|ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147833|NCT00406354|Secondary|Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity|"FBB-SSV (Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147834|NCT00406354|Secondary|Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity|"FBB-HKS (Fremdbeurteilungsbogen fur Hyperkinetische Storungen), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms."|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147835|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score|The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147836|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score|The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147837|NCT00406354|Secondary|Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score|The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147838|NCT00406354|Primary|Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score|The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.|9 weeks|All participants randomized and receiving at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
147839|NCT00406315|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16|The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
147854|NCT00406276|Primary|Time to Progression:Time Period (in Months) From Study Entry Until Disease Progression, Death, or Last Date of Contact.|"Period from study entry until disease progression, death, or last date of contact.~Progressive Disease: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|6 months|||Months||Full Range|Median
149599|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population|MITT Population|13 cycles, 28 days each (1 year)|MITT Population||Bleeding/Spotting Days||Standard Deviation|Mean
147840|NCT00406315|Secondary|Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16|GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
147841|NCT00406315|Secondary|Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16|The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
147842|NCT00406315|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16|The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
147843|NCT00406315|Secondary|Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16|The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject’s clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).|Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
147844|NCT00406315|Secondary|Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16|The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject’s overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
147845|NCT00406315|Secondary|Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16|PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.|Baseline, Week 16, Week 16 LOCF|Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.||scores on a scale||Standard Deviation|Mean
147846|NCT00406315|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16|AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.|Baseline, Week 16|Safety population.||scores on a scale||Standard Deviation|Mean
147847|NCT00406315|Secondary|Change From Baseline in Waist and Hip Circumference at Week 16|Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||centimeter||Standard Deviation|Mean
147848|NCT00406315|Secondary|Change From Baseline in Fasting Insulin at Week 16|Fasting insulin value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||microinternational (mciu)/milliliter(mL)||Standard Deviation|Mean
147849|NCT00406315|Secondary|Change From Baseline in Fasting Glucose at Week 16|Fasting glucose value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||mg/dL||Standard Deviation|Mean
147850|NCT00406315|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16|HbAlc value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||percent||Standard Deviation|Mean
147851|NCT00406315|Secondary|Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16|HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||mg/dL||Standard Deviation|Mean
147852|NCT00406315|Secondary|Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16|Total cholesterol value: Change = value at Week 16 minus value at Baseline.|Baseline, Week 16|Safety population.||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
149600|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population|MITT Population|6 cycles, 28 days each (168 days)|MITT Population||Bleeding/Spotting Days||Standard Deviation|Mean
147855|NCT00406276|Primary|Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.|"Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started."|6 weeks|24 patients received at least 2 cycles of therapy and underwent imaging studies to assess response.||participants|||Number
147856|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147857|NCT00406133|Other Pre-specified|Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147858|NCT00406133|Other Pre-specified|Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)|Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147859|NCT00406133|Post-Hoc|26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)|A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147860|NCT00406133|Other Pre-specified|26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)|A 26-week A1c level <7.0% was evaluated in logistic-regresssion models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147861|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase by in A1c level >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147862|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease A1c level by >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147863|NCT00406133|Secondary|Cost-effectiveness of CGM||26 weeks||12/2009||||
147864|NCT00406133|Secondary|Quality of Life||26 weeks||12/2009||||
147865|NCT00406133|Secondary|Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||mg/dl/min||Inter-Quartile Range|Median
147866|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
147867|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
147868|NCT00406133|Other Pre-specified|Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative increase in A1c level by >=10% was evaluated in logistic-regresssion models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147869|NCT00406133|Other Pre-specified|Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)|A relative decrease in A1c level >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||participants|||Number
147870|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
147871|NCT00406133|Secondary|Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
147911|NCT00405912|Primary|Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco|"Point prevalence tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question Have you used any type of tobacco,even a puff, in the past 7 days? and (b) Expired Carbon Monoxide equal or less then 8 parts per million."|12 weeks following start of medication|||participants|||Number
147872|NCT00406133|Secondary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort)|The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c <7.0% cohort), as determined by a central laboratory.|Baseline and 26 weeks|Analysis was performed according to Intention to Treat principle. Results based on non-missing data were reported. Imputation for missing data using Rubin's method did not alter the results (data not shown).||Percent||Standard Deviation|Mean
147873|NCT00406133|Secondary|Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)|Glucose variability was assessed by computing the absolute rate of change.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||Mean mg/dl/minute||Standard Deviation|Mean
147874|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
147875|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)|Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL)|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
147876|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort|Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
147877|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
147878|NCT00406133|Secondary|Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Standard Deviation|Mean
147879|NCT00406133|Secondary|Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)|Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c >=7.0% cohort|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||subjects with event|||Number
147880|NCT00406133|Primary|Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)|The primary outcome was the change in the time per day with glucose values <=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||minutes/day||Inter-Quartile Range|Median
147881|NCT00406133|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)|The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c >=7.0% cohort).|Baseline and 26 weeks|All analyses were performed according to the intention-to-treat principle.||Percent||Standard Deviation|Mean
147882|NCT00406107|Secondary|Change in Macular Volume on OCT From Baseline to Week 54||54 Weeks|||mm cubed||Standard Deviation|Mean
147883|NCT00406107|Secondary|Change in Central Subfield Thickness on OCT From Baseline to Week 54||54 Weeks|||microns||Standard Deviation|Mean
147884|NCT00406107|Secondary|Safety Parameters|Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug.|54 Weeks|||percentage of participants|||Number
147885|NCT00406107|Secondary|Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield||54 Weeks|Fifteen patients were enrolled in the pegaptanib 0.3 mg dose group and 5 patients were enrolled in the 1.0 mg dose group.||microns||Standard Deviation|Mean
147886|NCT00406107|Primary|Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks||54 Weeks|||ETDRS letters||Standard Deviation|Mean
147887|NCT00406029|Secondary|Change From Baseline in UPDRS Part 4|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 4 subscale assesses complications of therapy over the past week for a total of eleven question items. The first three questions and question 8 are rated from 0 (best) to 4 (worst), and the remaining seven questions are simple no (0) / yes (1) questions. The total subscale score ranges from 0 to 23. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline date (UPDRS Part 4) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
147912|NCT00405912|Secondary|Number of Subjects With Prolonged Abstinence From Tobacco|tobacco abstience during the 12-week course of SJW in two different oral doses of 300-mg three times a day or 600-mg three times a day compared to placebo at six months.|24 weeks after the start of medication|||participants|||Number
147913|NCT00405821|Secondary|Virologic and Immunologic Responses to ART in Those Who Progress to CD+4 Less Than 250cells/mL||6 months and 12 moths post ART initiation||||||
147888|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (2 Hours Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled standard deviation were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
147889|NCT00406029|Secondary|Change From Baseline in UPDRS Part 3 (1 Hour Post-dose)|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. The Part 3 subscale assesses motor function across 14 categories for 27 items. Scores for each item range from 0 (best) to 4 (worst) with a total range of 0-108. Assessments were obtained at baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 1 hour postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 3) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
147890|NCT00406029|Secondary|Change From Baseline in UPDRS Part 2|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 2 assesses daily living (13 items scored from 0 [best] to 4 [worst]; total range 0-52). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 2) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
147891|NCT00406029|Secondary|Change From Baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) Part 1|The UPDRS is a frequently used multi-item 4-part questionnaire designed to assess various aspects of Parkinson's disease severity. A total of 42 items are assessed divided across Parts 1 to 4. Part 1 assesses mentation (4 items scored from 0 [best] to 4 [worst]; total range 0-16). Assessments were obtained at baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, and 12. For endpoint, the last postbaseline visit while on study medication was used. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. Negative change from baseline indicates a decrease in severity.|Baseline (predose Day 1) and 2 hours postdose at Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (UPDRS Part 1) for the assessment week was used for analysis.||Units on a Scale||Standard Deviation|Least Squares Mean
147892|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 12|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 12) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 12 would be reported as BL >2 to WK12 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 12|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
147893|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 10|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 10) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 10 would be reported as BL >2 to WK10 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 10|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
147894|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 8|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 8) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 8 would be reported as BL >2 to WK8 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 8|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
147914|NCT00405821|Secondary|Adherence to Acyclovir||2 years||||||
147915|NCT00405821|Secondary|Toxicity of Acyclovir||2 years||||||
147895|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 6|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 6) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 6 would be reported as BL >2 to WK6 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 6|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
147896|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 4|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 4) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 4 would be reported as BL >2 to WK4 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 4|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
147897|NCT00406029|Secondary|Change From Baseline in Frequency of Sleep Attacks at Week 2|Sleep attacks are uncontrollable episodes of sleep that occur during the daytime lasting a few seconds to several minutes. A questionnaire to determine sleep attacks over the prior 2 week period was administered at baseline and at 2-week intervals during the treatment period. Frequency of sleep attacks over the two-week treatment period intervals were tabulated in relation to the baseline assessment. Results are presented as participants showing the respective change in frequency of sleep attacks at baseline to the week of assessment (Week 2) (as reported by the participant). For example, someone who had >2 sleep attacks at BL who had a decrease of 1-2 by Week 2 would be reported as BL >2 to WK2 1-2. BL = baseline. WK = week.|Baseline (predose Day 1) and 2 hours postdose at Week 2|The Efficacy Population consisting of all treated participants who had post-baseline data (sleep attacks) for the assessment week was used for analysis.||Participants|||Number
147898|NCT00406029|Secondary|Change From Baseline in Total Sleep Time|Hours spent in the sleep state were recorded using a daily diary at least 3 full days before scheduled visit. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A positive change from baseline means more time asleep and a negative change means less time asleep.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|The Efficacy Population consisting of all treated participants who had post-baseline data (total sleep time) for the assessment week was used for analysis.||hours/day||Standard Deviation|Least Squares Mean
147899|NCT00406029|Secondary|Change From Baseline in Absolute Duration of Dyskinesias|Dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination (that occur in the ON time). Hours spent with dyskinesias (troublesome and not troublesome) were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A negative change from baseline signifies less time spent with dyskinesia.|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome and not troblesome dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
147900|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (Without Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maint. therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state without troubles. dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (without troubles. dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state without troublesome dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
147908|NCT00405964|Primary|Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment|AM/PM PRIOR (the participant’s status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-29|All randomized participants||units on a scale||Standard Error|Least Squares Mean
147909|NCT00405938|Secondary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months||||||
147901|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (With Troublesome Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Troublesome dyskinesias refers to maintenance therapy side effects of chorea, dystonia, or in combination that impair function. Hours spent in the on state with troublesome dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained using ANCOVA with treatment effect & baseline covariate. A (+) change from baseline signifies more time spent in the on state (troublesome dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with troublesome dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
147902|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State (no Dyskinesias)"|"On time refers to periods of adequate control of Parkinson disease symptoms (better/absent). Dyskinesias refers to maintenance therapy (e.g., L-dopa) side effects of chorea, dystonia, or in combination. Hours spent in the on state with no dyskinesias during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means & pooled SD were obtained from an ANCOVA model with effect for treatment & baseline covariate. A (+) change from baseline signifies more time spent in the on state (no dyskinesias)."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state with no dyskinesias) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
147903|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the on State"|"On time refers to periods of adequate control of Parkinson disease symptoms (symptoms better or absent). Hours spent in the on state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with effect for treatment and baseline covariate. A positive (+) change from baseline signifies more time spent in the on state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the on state) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
147904|NCT00406029|Secondary|"Change From Baseline in Awake Time Per Day Spent in the Off State at Each Visit"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). Hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For treatment period visits, the 24-hour average was derived for the final 3 consecutive days with data available for the particular visit. Change from baseline in LS means and pooled SD were obtained from an ANCOVA model with treatment effect and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and Weeks 2, 4, 6, 8, 10, 12|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) for the assessment week was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
147905|NCT00406029|Primary|"Change From Baseline to Endpoint of 12 Weeks in the 3-day Average of Awake Time Per Day Spent in the Off State"|"Off time refers to periods of inadequate control of Parkinson disease symptoms (worsening or presence of symptoms). For baseline and the 12 weeks treatment period, hours spent in the off state during awake time were recorded in half-hour time intervals using a daily diary at least 3 full days before scheduled visits. For baseline, the 24-hour average over 3 consecutive days was derived for Week -1. For endpoint, the 24-hour average was derived for the last available 3 consecutive days with postbaseline data available during the treatment period. Change from baseline in least squares (LS) means and pooled standard deviation (SD) were obtained from an analysis of covariance (ANCOVA) model with effect for treatment and baseline covariate. A negative change from baseline signifies less time spent in the off state."|Baseline (Week -1) and up to 12 weeks|"The Efficacy Population consisting of all treated participants who had post-baseline data (awake time per day in the off state) was used for analysis."||hours/day||Standard Deviation|Least Squares Mean
147906|NCT00405964|Secondary|Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment|AM/PM PRIOR (the participant’s status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Days 1-85|All randomized participants||units on a scale||Standard Error|Least Squares Mean
147907|NCT00405964|Secondary|Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment|The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.|Baseline and Day 29|All randomized participants||units on a scale||Standard Error|Least Squares Mean
147916|NCT00405821|Secondary|HIV-1 Viral Load Difference Between Arms|We measured mean annual rate of change in log10 viral load (copies/mL) for each group. We assessed difference in annual rate of change in log10 viral load (copies/mL) between groups.|baseline, 6 months, 12 months, 18 months, 24 months|We measured viral load at baseline and at 6 monthly follow-up visits during 24 months of follow-up for all subjects randomized on this study.||log10 (copies/mL)||95% Confidence Interval|Mean
147917|NCT00405821|Secondary|Difference in Number of Episodes of Genital Ulcer Disease Between Arms|We calculated incidence rate for each treatment arm for episodes of genital ulcer disease, and incidence rate ratio.|2 years|We conducted monthly clinical assessment for GUD on all randomized subjects during their entire follow-up period on this trial. The number of episodes of GUD is shown below.||episodes|||Number
147918|NCT00405821|Primary|Progression to AIDS (CD4+ Less Than 250 Cells/Microliter or World Health Org Stage IV dx, Excluding Esophageal Candidiasis)|Evaluate the effect of acyclovir prophylaxis vs placebo among HIV-1/HSV-2 co-infected individuals on the progression to AIDS (CD4+ less than 250 cells/microliter or World Health Org stage IV disease, excluding esophageal candidiasis)|2 years|Intention to treat analysis of all subjects randomized on the trial meeting the primary endpoint||participants|||Number
147919|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147920|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147921|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147922|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147923|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147924|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147925|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147926|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147947|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen||2 years|The analysis population is restricted to the 38 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 69 subjects in the placebo group who had a recurrent UTI with an organism for which sensitivity to TMP-SMZ was assessed.||participants|||Number
147927|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147928|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147929|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147930|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147931|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147932|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147933|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147934|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147935|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147936|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale|Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147948|NCT00405704|Secondary|Recurrent Febrile or Symptomatic UTI With Resistant E. Coli||2 years|The analysis population is restricted to the 30 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 57 subjects in the placebo group who had a recurrent UTI with E. coli for which sensitivity to TMP-SMZ was assessed.||participants|||Number
147937|NCT00405756|Secondary|Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale|Data as of 11 May 2010 cutoff. EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.|Baseline (Day 0), Months 4, 7, 10, 13, 16|Intent to treat population||units on a scale||Standard Deviation|Mean
147938|NCT00405756|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period|Data as of 11 May 2010 cutoff. Participant counts in different categories of TEAEs during the double-blind treatment period. A TEAE is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. Dose reduction includes reduction with or without interruption.|Up to 169 weeks (Double-blind therapy period plus 4 weeks)|Safety population||participants|||Number
147939|NCT00405756|Secondary|Kaplan Meier Estimates for Time to Next Antimyeloma Therapy|Data as of 11 May 2010 cutoff. Time to the next antimyeloma therapy was defined as time from randomization to the start of another non-protocol antimyeloma therapy. Participants who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.|Up to 168 weeks|Intent to treat population||weeks||95% Confidence Interval|Median
147940|NCT00405756|Secondary|Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. Duration of myeloma response was defined as the time from the initial response date to the earlier of progressive disease (PD) as determined by the CAC or death on study. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Up to 149 weeks|Population: Participants who achieved a partial response (PR) or complete response (CR).||weeks||95% Confidence Interval|Median
147941|NCT00405756|Secondary|Time to First Response|Data as of 11 May 2010 cutoff. Time to first response was defined as the time from start of treatment until first response as assessed by the Central Assessment Committee (CMC) based on European Group for Blood and Marrow Transplantation (EBMT) criteria.|Up to 66 weeks|Participants who had a partial response (PR) or complete response (CR)||weeks||Standard Deviation|Mean
147942|NCT00405756|Secondary|Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period|Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).|Up to 165 weeks|Intent to treat population||participants|||Number
147943|NCT00405756|Secondary|Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. TTP was the time between randomization and disease progression as determined by the CAC. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent to treat population||weeks||95% Confidence Interval|Median
147944|NCT00405756|Secondary|Kaplan Meier Estimates of Overall Survival (OS)|Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier.|up to 177 weeks|Intent to treat population||weeks||95% Confidence Interval|Median
147945|NCT00405756|Secondary|Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS calculated from the start of the Maintenance period to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause.~PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|Approximately week 37 (start of cycle 10) to week 165|Intent to treat (ITT) population of participants in Arms MPR+R and MPR+p who entered maintenance within the Double-blind Treatment Period||weeks||95% Confidence Interval|Median
147946|NCT00405756|Primary|Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)|"Data as of 11 May 2010 cutoff. PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD) as determined by the CAC, or death on study due to any cause. PD was based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria.~PD criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia."|up to 165 weeks|Intent-to-treat population||weeks||95% Confidence Interval|Median
147949|NCT00405704|Secondary|Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)||2 years|The analysis population excluded 99 subjects in the trimethoprim-sulfamethoxazole group and 95 subjects in the placebo group who did not have stool analyzed at the outcome visit.||participants|||Number
147950|NCT00405704|Secondary|Treatment Failure Composite|Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.|2 years|||participants|||Number
147951|NCT00405704|Secondary|New Renal Scarring on Outcome Scan|New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 82 subjects in the trimethoprim-sulfamethoxazole group and 78 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.||participants|||Number
147952|NCT00405704|Secondary|Severe Renal Scarring on Outcome Scan|Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.||participants|||Number
147953|NCT00405704|Secondary|Outcome Renal Scarring|Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.|2 years|The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.||participants|||Number
147954|NCT00405704|Primary|Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up||2 years|||participants|||Number
147955|NCT00405652|Secondary|The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes|The number of participants with subclinical rejection episodes as defined by a steroid-sensitive, clinically relevant increase of AST, ALT, gamma-GT, AP or bilirubin (i.e., elevation of one or more of these enzymes that was considered clinically relevant and showed resolution upon treatment with a slight increase of steroid dosage).|12-20 weeks|Intent to Treat||Participants|||Number
147956|NCT00405652|Primary|Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life|Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.|Baseline, End of Study (6-8 weeks)|Intent to Treat Population (No last Observation Carried Forward). The number of participants completing the GSRS at Baseline = 31 and at the End of Study= 29.||Scores on a Scale||Standard Deviation|Mean
147957|NCT00405639|Primary|Change in Urinary Sodium Excretion in Response to Saline Load||baseline, 12 weeks|||mEq/min||Standard Deviation|Mean
147958|NCT00405639|Secondary|Change in Left Ventricular Mass Index|Left ventricular mass index (LVMI) is a surrogate of left ventricular hypertrophy and a predictor of cardiac morbidity and mortality in adults with hypertension. LVMI was measured with echocardiography, indexed to body surface area estimated by left ventricular (LV) cavity dimension and wall thickness at end-diastole.|baseline, 12 weeks|||g/m^2||Standard Deviation|Mean
147959|NCT00405639|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|baseline, 12 weeks|||ml/min/1.73 m^2||Standard Deviation|Mean
147960|NCT00405639|Secondary|Change in Urine Flow in Response to Saline Load||baseline, 12 weeks|||ml/min||Standard Deviation|Mean
147961|NCT00405548|Secondary|Left Ventricular (LV) Filling Pressure|LV diastolic function as measured by Doppler echocardiography. E/e' is the ratio of the mitral inflow velocity (E) to the mitral annulus tissue Doppler velocity (e'). A decrease in the ratio indicates a lower filling pressure and improved LV diastolic function.|Baseline, 12 weeks|||E/e'||Standard Deviation|Mean
147962|NCT00405548|Primary|Change in Urinary Sodium Excretion in Response to Saline Load|Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).|Baseline, 12 weeks|||mEq/minute||Standard Deviation|Mean
147963|NCT00405548|Secondary|Change in Glomerular Filtration Rate (GFR) in Response to Saline Load|Renal or kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/ml/1.73 m^2 of body surface area is considered to be impaired kidney function.|Baseline, 12 weeks|||ml/min/1.73 m^2 body surface area||Standard Deviation|Mean
147964|NCT00405548|Secondary|Change in Urinary Flow in Response to Saline Load|Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute.|Baseline, 12 weeks|||ml/minute||Standard Deviation|Mean
147965|NCT00405509|Secondary|Severity of Symptom Score - SNEEZING|Sneezing symptoms were rated by participants once a day for six days and on Day 30, symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on Day 30|||units on a scale||Standard Deviation|Mean
147966|NCT00405509|Secondary|Severity of Symptom Score - NASAL CONGESTION|nasal congestion symptoms were rated by the participant once a day for six days and on day 30. Symptoms were rated from 0 - 3 corresponding to none, mild, moderate and severe, respectively.|once a day for six days and on day 30|||units on a scale||Standard Deviation|Mean
151882|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Post intervention|||units on a scale||Standard Deviation|Mean
147976|NCT00405288|Secondary|Low Birth Weight at Birth|Low birth weight (birth weights <2500 grams)|at birth|Per protocol, the estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight (primary outcome) for a power of 80% and alpha of 5% was used.||participants|||Number
147977|NCT00405288|Secondary|Fetal Distress|Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid|at birth|||participants|||Number
147978|NCT00405288|Secondary|Prematurity|birth at <37 gestational weeks|at birth|||participants|||Number
147979|NCT00405288|Secondary|Mode of Delivery|Method of delivery for both groups: vaginal or caesarean section|at birth|||participants|||Number
147980|NCT00405288|Secondary|Gestational Age at Delivery|Fetal gestational age at delivery|until delivery|||gestational weeks||Standard Deviation|Mean
147981|NCT00405288|Primary|Birth-weight|Weight of the baby measured in grams at time of birth.|until delivery|Estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight at a power of 80% and alpha of 5%. Seven pairs of twin pregnancies were excluded from the comparison of birth weight.||grams||Standard Deviation|Mean
147982|NCT00405275|Primary|Mean 48-week Change in DAS28|"Average difference between 48-week and Baseline DAS28.~The Disease Activity Score for 28 Joints (DAS28) is a well-validated composite outcome measure ranging from 2-10 (higher scores indicating more disease) that incorporates a tender and swollen joint count of 28 joints, a laboratory measure of systemic inflammation (ESR) and a patient-reported general assessment of health on a visual analog scale (ranging from 0-10cm) all into one measure.~Low disease activity is defined as DAS28 ≤ 3.2 units."|48 weeks after baseline assessment|Intention to treat analysis was performed on participants with Week 48 DAS28 data.||units on a scale||Standard Deviation|Mean
147983|NCT00405067|Secondary|Percent Change in Body Weight at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147984|NCT00405067|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147985|NCT00405067|Secondary|Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147986|NCT00405067|Secondary|Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline||baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147987|NCT00405067|Secondary|Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147988|NCT00405067|Secondary|Percent Change in HDL-C at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147989|NCT00405067|Secondary|Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147990|NCT00405067|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147991|NCT00405067|Secondary|Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147992|NCT00405067|Primary|Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments||Baseline and 12 weeks of treatment|||Percent Change||Standard Deviation|Mean
147993|NCT00404924|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF)|Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||weeks||Inter-Quartile Range|Median
147994|NCT00404924|Primary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||95% Confidence Interval|Median
147995|NCT00404924|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression|||Weeks||95% Confidence Interval|Median
147996|NCT00404924|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression|||Participants|||Number
147997|NCT00404924|Secondary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 8 weeks, progressive disease (PD) or NE."|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression.|||Participants|||Number
147998|NCT00404924|Secondary|Progression-Free Survival (PFS)|Median time (in months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment|RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression|||month||95% Confidence Interval|Median
147999|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Per Protocol population: All intent-to-treat patients who did not show major deviations from the protocol procedures that may have had an impact on the study outcome.||ng/ml||Standard Deviation|Mean
148000|NCT00404820|Secondary|Therapy Preference at End of Study (Month 12)|Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.|Month 12|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||Participants|||Number
148001|NCT00404820|Secondary|Change in Body Height From Baseline to Month 12|Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||cm||Standard Deviation|Mean
148002|NCT00404820|Secondary|Number of Patients With a Clinical Fracture From Baseline to Month 12|A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||Participants|||Number
148003|NCT00404820|Secondary|Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12|The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.|Baseline to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||Units on a scale||Standard Deviation|Mean
148004|NCT00404820|Secondary|Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12|The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||ng/ml||Standard Deviation|Mean
148005|NCT00404820|Primary|Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population|The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.|Screening to end of study (Month 12)|Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.||ng/ml||Standard Deviation|Mean
148006|NCT00404651|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability|Day 0 (pre-each vaccination) up to 7 days post-each dose|Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome||Participants|||Number
148007|NCT00404651|Secondary|Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).|Day 150 (one month post-dose 3)|Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
148008|NCT00404651|Primary|Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).|Day 150 (one month post-dose 3)|Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
148009|NCT00404651|Primary|Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.|Day 150 (one month post-dose 3)|Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
148010|NCT00404651|Primary|Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine|Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.|Day 150 (one month post-dose 3)|Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.||Participants|||Number
148011|NCT00404547|Secondary|Assessment of Patient Treatment Satisfaction||12 weeks||||||
148012|NCT00404547|Secondary|Assessment of Patient Compliance During the Study||12 weeks||||||
148013|NCT00404547|Secondary|Change in Patient Assessment of Asthma Control|"Patient assessment of asthma control was assessed at baseline and at week 12 using the question How would you rate the control of your asthma symptoms?. The change in this assessment was categorized in Improvement and Non-Improvement."|At baseline and at week 12|Basis is the ITT population||participants|||Number
148014|NCT00404547|Primary|Change in Mean of Total Score of Asthma Control Questionnaire (ACQ)|The score of the change from baseline ranges from –6 (=best possible outcome) to 6 (=worst possible outcome).|At the middle and end of the 12 week treatment period|Basis is the ITT population||points on a scale||Standard Deviation|Mean
148015|NCT00404495|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). Investigator's assessment.|Baseline to Date of Death (Up to 1 Year After Treatment)|All participants. One participant in the Temozolomide + Irinotecan for Medulloblastoma cohort did not have recurrent or refractory medulloblastoma and 3 participants in the Temozolomide + Irinotecan for High-Grade Glioma cohort did not have high-grade glioma, and were not considered evaluable for survival.||months||95% Confidence Interval|Median
148016|NCT00404495|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7 multiplied by 4.33. Tumor progression was determined from oncologic assessment data (where data met the criteria for PD). Investigator's assessment.|Baseline to Date of Progression (Up to 1 Year)|Evaluable local population||months||95% Confidence Interval|Median
148017|NCT00404495|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD), the date of treatment discontinuation except completion of treatment, or date of death due to cancer. Investigator's assessment.|Baseline to Date of Treatment Failure (Up to 1 Year)|Evaluable local population||months||95% Confidence Interval|Median
148018|NCT00404495|Secondary|Duration of Response|Median duration (50%) of tumor response for participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR was defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurred first. DR (calculated in Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7. Investigator's assessment.|Baseline to Date of Tumor Response (Up to 1 Year)|Evaluable local population. Number of participants analyzed=number of participants who responded.||weeks||Full Range|Median
148019|NCT00404495|Secondary|Percentage of Participants With Objective Response of Complete Response or Partial Response, Investigator's Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR. CR persisted on repeat imaging study ≥4 weeks after initial documentation of response. PR, in case of bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response could be recorded any time while the participant was receiving treatment. Investigator's assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Evaluable local population: Participants received at least 1 dose of study medication, had measurable disease under study, at least 1 on-study objective tumor assessment, completed at least 2 cycles of study treatment or progressed. Based on investigator's assessment.||percentage of participants||95% Confidence Interval|Number
148020|NCT00404495|Primary|Percentage of Participants With Objective Response of Complete Response or Partial Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR persisted on repeat imaging study at least (≥) 4 weeks after initial documentation of response. PR, for bidimensionally measurable disease, was a decrease by ≥50% of the sum of the products of the largest perpendicular diameters of all measurable lesions as determined by 2 observations not less than 4 weeks apart. Best overall response recorded any time while the participant was receiving treatment. External Response Review Committee (ERRC) assessment.|Baseline to 1 Year (medulloblastoma), Baseline to 6 Weeks (high-grade glioma)|Primary Evaluable Population: subset of evaluable population predetermined by 2-stage Optimum Simon design. Medulloblastoma cohort: n=consecutive evaluable participants up to 46 if 6 responses obtained in first 15 evaluable participants. Glioma cohort: n=consecutive evaluable participants up to 29 if 1 response in first 10 evaluable participants.||percentage of participants||95% Confidence Interval|Number
148021|NCT00404352|Secondary|Change From Baseline in Expanded Disability Status Score (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS at Month 36 was calculated as EDSS at Month 36 minus EDSS at baseline.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||unit on a scale||Standard Deviation|Mean
148022|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 36 months|Open label (OL) ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.||days||95% Confidence Interval|Median
148023|NCT00404352|Secondary|Change From Baseline in Time Constant 2 (T2) Lesion Volume , Time Constant 1 (T1) Hypointense Lesion Volume and Gadolinium Enhanced (Gd+) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T2 lesions, T1 hypointense lesions and (Gd+) lesions.|Baseline, Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||cubic millimeter (mm^3)||Standard Deviation|Mean
148024|NCT00404352|Secondary|Mean Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Hypointense Lesions Per Participant Per Scan|Number of CUA lesions, new T2 lesions, Gd+ lesions and new T1 hypointense lesions were measured by using MRI scans.|Month 24 up to Month 36|"OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."||lesions||Standard Deviation|Mean
148025|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 36 months in participants who presented with FCDE accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 36 months|OL ITT population included all participants who were randomized at baseline in core REFLEX trial and entered the 12 months OLE period.||days||95% Confidence Interval|Median
148026|NCT00404352|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a 3-Month Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score|CDMS was defined by the occurrence of a second exacerbation or relapse over 24 months in participants who presented with first clinical demyelinating event (FCDE) accompanied by an abnormal MRI scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Various time points from randomization up to 24 months|ITT population included all participants who were randomized to the assigned study treatment.||days||95% Confidence Interval|Median
148027|NCT00404352|Primary|Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005)|The McDonald criteria use dissemination in time and space established by magnetic resonance image (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Various time points from randomization up to 24 months|Intent-to-treat (ITT) population included all participants who were randomized to the assigned study treatment.||days||95% Confidence Interval|Median
148028|NCT00404248|Secondary|Survival|Survival measured from first day of treatment to date of death|time to death - up to 12 months|3 pts still alive at time of analysis||months||Standard Deviation|Median
148029|NCT00404248|Secondary|Efficacy - Best Overall Response|Response Criteria: Complete Response (CR): complete disappearance of all tumor, off all steroids, stable or improving neuro exam for min of 4wks; Partial Response (PR): Greater than 50% reduction in tumor size, bi-dimensional MRI/CT, stable steroids, stable or improving neuro for min of 4 wks; Progressive Disease (PD): Progressive neurologic abnormalities not explanined by causes unrelated to tumor progression, or 25% increase in size of tumor by MRI/CT scan, or if new lesion appears; Stable Disease (SD): patient whose clinical status and MRI/CT measurements do not meet the criteria for CR, PR or PD.|About 2 years|3 pt did not have proper scans to be evaluable for analysis||participants|||Number
148030|NCT00404248|Secondary|Pharmacokinetics - Terminal Phase Half-life|effect of hepatic enzyme-inducing drugs on PKs|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs for Arm 3 (All EIASD) were collected. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis||Hour||Standard Deviation|Mean
148031|NCT00404248|Secondary|Pharmacokinetics - Steady-State Apparent Volume Distribution|"effect of hepatic enzyme-inducing drugs on PKs~Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.~Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|no PKs were collected for Arm 3. Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis||Liters||Standard Deviation|Mean
148032|NCT00404248|Secondary|Pharmacokinetics - Total Body Clearance|"effect of hepatic enzyme-inducing drugs on PKs~Cycle 1 Day 1 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.~Cycle Day 5 of treatment: Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs."|Cycle 1 Day 1- Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs. and Cycle 1 Day 5 Predose: 1hour(hr) prior, 15minutes(min) prior; postdose: 1 hr15 min; 1.5hr, 2, 3,4, 6, 24 hrs.|No PKs were collected for the three patients who were treated on Arm 3 (all EIASD). Due to incomplete collection of PKs on Cycle 1 Day 5 only the PKs from Cycle 1 Day 1 were used in the analysis||Liters/hour||Standard Deviation|Mean
148033|NCT00404248|Primary|Maximum Tolerated Dose (Phase I) - Dose Limiting Toxicity (DLT)|Dose limiting Toxicity defined as: Treatment related events; absolute neutrophil count </=500 /mm3; platelets count </=25,000/mm3; febrile neutropenia; any grade 3 or 4 non-hematologic toxicity; any delay in starting subsequent course of treatment for >14 days because of incomplete recovery from treatment|First 30 days|"+EIASD on hepatic enzyme-inducing drugs; -EIASE not on hepatic enzyme-induzing drug or drugs that significantly induce the hepatic enzyme.~IV Formulations: +PEG; 10mg/mL solution of PEG 300, hydroxypropyl-B-cyclodextrin & water ; -PEG; 6mg/mL, hydroxypropyl-B-cyclodextrin & water - NEW TC6 formulation"||Dose Limiting Toxicities (DLT)|||Number
148034|NCT00404248|Primary|Maximum Tolerated Dose (Phase I)|Using the PEG formulation pts both with and without enzyme inducing antiseizure drugs (EIASD) were treated at Doses 750, 1100, 1700, 2200 mg/day for five days = 28pts Using the PEG free formulation pts with and without EIASD) were treated at 1700 and 2200 mg/day X 5 days = 8pgs|first 30 days of treatment|||mg/day x 5 days|||Number
148035|NCT00404092|Primary|Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis|Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.|End of caspofungin treatment, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)|||events|||Number
148036|NCT00404092|Secondary|Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.|"Numbers of patients in each dose cohort according to invasive aspergillosis (IA) outcome at end of protocol treatment (EOT), 4 weeks follow-up (4w FU) and 12 weeks follow-up (12w FU), respectively. 12w FU was only required for patients with a CR or PR at the 4w FU.~Definitions:~CR: resolution of all attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.~PR: clinically meaningful improvement in attributable symptoms, signs, and radiographic (min. 50% decrease) or bronchoscopic abnormalities.~Stable disease (SD): no improvement in attributable symptoms, signs, and radiographic or bronchoscopic abnormalities.~Failure: deterioration in attributable clinical or radiographic abnormalities necessitating alternative antifungal therapy or resulting in death.~Relapse: reemergence of IA after EOT following CR, PR or SD or early withdrawal."|End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up|All 46 recruited patients were included in the analysis. 2 (EOT), 16 (4w FU) and 23 (12w FU) outcomes out of 46 were not recorded.||participants|||Number
148037|NCT00404079|Secondary|EuroQol-5D||1 year||||||
148038|NCT00404079|Secondary|Visual Analogue Scale||1 year||||||
148039|NCT00404079|Primary|Roland Morris Disability Questionnaire|The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.|1 year|The number of participants for analysis followed the intention to treat principle. Imputation was performed with mulitple imputation.||units on a scale (0-24)||Standard Deviation|Mean
148040|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.||Liters||Standard Error|Least Squares Mean
148041|NCT00403845|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, 4, 8, and 12 hours on Day 1 and 22, 23, and 24 hours on Day 2. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 12 hours post-dose on Day 1 and from 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||90% Confidence Interval|Least Squares Mean
148042|NCT00403845|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 5, 15, and 30 minutes and 1, 2, and 4 hours post-dose on Day 1. The analysis included baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
148081|NCT00403403|Secondary|Number of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.~Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):~Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)|||number of participants|||Number
148043|NCT00403845|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made in each treatment period at 22, 23, and 24 hours post-dose on Day 2. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included patient, period, and treatment group as fixed effects and baseline FEV1 prior to drug administration in the treatment period as a covariate.|From 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were included in the analysis if they had at least 1 FEV1 value at 22, 23, or 24 hours post-dose, and the data were not collected within 6 hours after the use of rescue medication.||Liters||Standard Error|Least Squares Mean
148044|NCT00403767|Secondary|All-cause Mortality|The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148045|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death|The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148046|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction|The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148047|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism|The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148048|NCT00403767|Secondary|The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke|The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148049|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148050|NCT00403767|Secondary|The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death|The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148051|NCT00403767|Primary|The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety|The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.||Patients|||Number
148052|NCT00403767|Primary|The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The safety population consisted of all randomized unique patients who took at least 1 dose of study medication after randomization during the double-blind treatment period. Site 042012 with GCP violation was excluded.||Patients|||Number
148053|NCT00403767|Primary|The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)|The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.|Up to 4 years|The per-protocol (PP) population consisted of all randomized unique patients excluding those who had specific pre-defined major protocol deviations that occurred by the time of enrollment into the study or during the trial. Site 042012 with GCP violation was excluded.||Patients|||Number
148082|NCT00403403|Secondary|Percentage of Participants With an Objective Response|"Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.~Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST):~Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR"|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population||Percentage of participants|||Number
148054|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes Post-dose on Day 1 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC0-24h) of FEV1 values taken at pre-dose to 24 hours post dose was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 12 hours post-dose on Day 1; and 22 to 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
148055|NCT00403754|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) From 5 Minutes to 4 Hours Post-dose on Day 1|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 minutes to 4 hours post-dose on Day 1|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
148056|NCT00403754|Secondary|Forced Expiratory Volume in 1 Second (FEV1) by Time Point From 5 Minutes to 12 Hours Post-dose on Day 1 and From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. FEV1 by time point was calculated using a mixed model with (period) baseline, defined as the value measured prior to the first study drug intake in the period, as a covariate.|5, 15, and 30 minutes; and 1, 2, 4, 8, and 12 hours post-dose on Day 1; and 22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||90% Confidence Interval|Least Squares Mean
148057|NCT00403754|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 22 to 24 Hours Post-dose on Day 2|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC22-24h) of FEV1 values taken at 22, 23 and 24 hours post dose, was calculated based on the trapezoidal rule. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|22, 23, and 24 hours post-dose on Day 2|Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug.||Liters||Standard Error|Least Squares Mean
148058|NCT00403585|Secondary|Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event|The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.|Treatment Phase (Weeks 53-156)|ITT Population||participants|||Number
148059|NCT00403585|Secondary|Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156|Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody [HBeAb] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody [HBsAb] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively.|Week 104 and 156|All participants achieving viological response, defined as an HBV DNA level ≤ 300. Some participants were not tested at various weeks.||Participants|||Number
148060|NCT00403585|Secondary|HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156|Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156|Study ADF103814 ITT Population. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed. Some participants were not tested at various weeks.||log 10 copies/mL||Standard Deviation|Mean
148061|NCT00403585|Secondary|Number of Participants Achieving Virological Response at Week 104 & 156|Virological response is defined as HBV DNA level<300 copies/ml|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.||Participants|||Number
148062|NCT00403585|Secondary|Number of Participants Achieving ALT Normalization at Week 104 & 156|Alanine aminotransferase (ALT) normalization is defined as a value <= upper limit of normal (ULN) range based on the set of subjects with ALT>ULN at baseline. The normal range for ALT is 0-40 Units/Liter.|Week 104, Week 156|ITT Population: some participants were not tested at Weeks 104 or 156.||Participants|||Number
148063|NCT00403585|Primary|Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.|Baseline, Week 156|Study ADF103814 Intent-to-Treat (ITT) Population: All subjects regardless of whether or not the subject completed the planned duration of the study will be analyzed with no data exclusion. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed.||log10 copies/mL||Standard Deviation|Mean
148064|NCT00403481|Secondary|Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
148083|NCT00403403|Secondary|Overall Survival|Duration of overall survival from randomization until death or loss to follow-up|Randomization until death or lost of follow-up (up to 27 months)|Intent-to-treat population||Months||95% Confidence Interval|Median
148084|NCT00403403|Primary|Progression-free Survival (PFS)|Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.|Randomization until progression or lost to follow-up (up to 2 years)|Intent-to-treat population||Months||95% Confidence Interval|Median
148065|NCT00403481|Secondary|Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 Weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 participants, only 169 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
148066|NCT00403481|Secondary|Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
148067|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
148068|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements||mm Hg||Standard Error|Mean
148069|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
148070|NCT00403481|Secondary|Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 169 had the required measurements for this outcome analysis.||mm Hg||Standard Error|Mean
148071|NCT00403481|Secondary|Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
148072|NCT00403481|Primary|Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.|Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.|baseline and 12 weeks|A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.||mm Hg||Standard Error|Mean
148073|NCT00403455|Secondary|(Short Form -36 Health Care Quality of Life Scale).||12 weeks||||||
148074|NCT00403455|Secondary|DTS||12 weeks||||||
148075|NCT00403455|Secondary|Q-LES-Q||12 weeks||||||
148076|NCT00403455|Secondary|Ham-D||12 weeks||||||
148077|NCT00403455|Secondary|CGI-I||12 weeks||||||
148078|NCT00403455|Secondary|CGI-S||12 weeks||||||
148079|NCT00403455|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS assessment is used to determine the severity of an individuals PTSD. The assessment examines Re-experiencing, Avoidance and Numbing, and Hyperarousal symptoms which total score in each of these categories are added together to achieve a total CAPS score. Scores on this assessment can range from 0-136 with 0 not having any PTSD symptoms and 136 having the most symptoms possible. The study uses this assessment at the baseline and at the end of treatment to determine the decrease in this score over the course of the study.|12 weeks|All participants analyzed had a CAPS score of >45 and were DSM-IV positive for PTSD. Both males and females with backgrounds in all ethnic groups were aloud to participate in the study.||Change in units on a scale||Full Range|Mean
148080|NCT00403403|Secondary|Duration of Objective Response|Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.|Randomization until progression or lost to follow-up (up to 2 years)|Randomized patients with measurable disease at baseline.||Months||95% Confidence Interval|Median
148085|NCT00403273|Secondary|McGill Sensory Pain Score|McGill Sensory pain score on 0-33 at 2-month FU visit (higher score is worse)|2-month|patients providing data||units on a scale||Standard Deviation|Mean
149730|NCT00390780|Secondary|Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet|Number of patients with detectable plasma concentration at Visit 3 (day 7)|7 days|ITT (all randomized patients who took at least 1 dose of study medication)||participants|||Number
148086|NCT00403273|Secondary|Correlation of Change in Joint Fluid Cytokine Levels With Improvement in Pain|Change in pain on WOMAC pain subscale score (range 0-100; higher number is worse); sensitivity analyses change in numeric rating scale (NRS) pain score (range 0-100; higher number is worse)|Baseline to 2-months||06/2017||||
148087|NCT00403273|Secondary|Correlation of Baseline Joint Fluid Cytokine Levels With Baseline Pain|Baseline pain on the WOMAC pain subscale score (range 0-100; higher number is worse)|Baseline values||06/2017||||
148088|NCT00403273|Secondary|McGill Affective Dimension|McGill Affective Dimension Score on 0-12 scale at 2-months (higher number is worse)|2-month|patients providing data||units on a scale||Standard Deviation|Mean
148089|NCT00403273|Secondary|Manual Muscle Strength Testing of Knee Flexion and Extension|Occurence of decrease in strength of knee flexion or extension at any of the follow-up visits, as measured by the Manual muscle strength testing (MMT) with scores ranging 0-5; 0 indicates None: No visible or palpable contraction; 1 indicates Trace: Visible or palpable contraction with no motion; 2 indicates Poor: Full range of motion (ROM) gravity eliminated; 3 indicates Fair: Full ROM against gravity; 4 indicates Good: Full ROM against gravity, moderate resistance; and 5 indicates Normal: Full ROM against gravity, maximal resistance|Upto 6-months|patients providing the data||participants|||Number
148090|NCT00403273|Secondary|Number of Participants With Occurrence of Joint Erythema, Warmth, Swelling or Tenderness|Occurence of any of the above clinical features (erythema, warmth, swelling or tenderness) as a new finding compared to the absence of the same feature at baseline|Upto 6 months|patients providing data||participants|||Number
148091|NCT00403273|Secondary|QOL: SF-36 Score Physical Functioning Scale, a Generic Health Status Measure|Short Form (SF)-36 physical functioning subscale on 0-100, at 2-month FU visit, as a generic health status measure, with a score ranging from 0 (worst physical functioning) to 100 (best physical functioning), with higher score indicating better physical functioning (higher number is better)|2-month|patients providing data||units on a scale||Standard Deviation|Mean
148092|NCT00403273|Secondary|Timed Up-and-go (TUG) Test|Time to get up from a chair, walk 3 meters turn back and sit in the chair in seconds at the 2-month visit (higher number is worse, i.e., taking a longer time to complete the task is worse)|2-month|patients providing data||seconds||Standard Deviation|Mean
148093|NCT00403273|Secondary|WOMAC Stiffness (0-100)|WOMAC stiffness subscale score on 0-100 scale at 2-month follow-up visit with scores ranging 0 (no joint stiffness) to 100 (worst joint stiffness), with higher score indicating worse joint stiffness|2-months|patients providing the data||units on a scale||Standard Deviation|Mean
148094|NCT00403273|Secondary|Physical Function Subscale of the WOMAC at 2-months|Physical Function subscale score of the WOMAC at 2-months on a 0 (best physical function) to 100 (worst physical function), with higher score indicating worse physical function|2-month|people providing data at 2-months||units on a scale||Standard Deviation|Mean
148095|NCT00403273|Secondary|Physician Global Assessment of Response to Treatment|Physician global assessed on an ordinal scale with very much improved category as the outcome of interest (compared to all other categories of global assessment as reference category)|2-month (primary end-point)|2 patients did not have the outcome assessment; 1 lost to FU||participants|||Number
148096|NCT00403273|Secondary|Mean Pain VAS (0-10)|VAS pain score at 2-month post-injection; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain) with higher score indicating worse pain|2-months post-injection|patients providing pain VAS data at 2-month FU visit||units on pain VAS scale||Standard Deviation|Mean
148097|NCT00403273|Primary|Participants With Clinically Meaningful Improvement in Pain Severity (0-10 cm; Higher Score on Pain Scale is Worse)|2-point reduction in pain Visual Analog Scale (VAS) from baseline to the 2-month follow-up visit, which is considered clinically meaningful Change in Pain Severity; Pain Severity on VAS ranges from 0 (no pain) to 10 (maximum pain)|2-month post-injection|all with follow-up data, allowing only single TKA per participant||participants|||Number
148098|NCT00403234|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.|From signed informed consent to 7 days after end of study (approx. 35 days)|The Safety Population consisted of subjects who were randomized, received at least 1 dose of double-blind study drug and had at least 1 safety assessment during double-blind treatment.||participants|||Number
148099|NCT00402987|Other Pre-specified|No Perceptible Relief|Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population~Number of subjects at each time point (in hour) is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"||subjects|||Number
148100|NCT00402987|Other Pre-specified|First Perceptible Relief|Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief).|up to 24 hours|"MITT population~Number of subjects assessed at each hour is: N = Celecoxib 50mg/50mg, Celecoxib 100mg/Placebo, Celecoxib 100mg/50mg, Placebo"||subjects|||Number
148101|NCT00402987|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM vII)|11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment.|24 hours or immediately prior to taking rescue medication|MITT population||scores on a scale||Standard Deviation|Mean
148102|NCT00402987|Other Pre-specified|Subjects Taking Rescue Medication|Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug.|Within 24 hours Post-First Dose|MITT population||subjects|||Number
148103|NCT00402987|Other Pre-specified|Treatment Failures on STRRS Questionnaire|Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief.|24 hours Post-First Dose|MITT population||subjects|||Number
148104|NCT00402987|Other Pre-specified|Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief.|24 Hours|Number of subjects who achieved Meaningful Relief within 6 hours||hours||Full Range|Median
148105|NCT00402987|Other Pre-specified|Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose|Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study.|24 Hours|Number of subjects who achieved meaningful relief within 6 hours||hours||Full Range|Median
148106|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose|At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0|12 and 24 hours Post-First Dose|MITT population||subjects|||Number
148107|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour|At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0.|Within 6 hours Post-First Dose|MITT population||subjects|||Number
148108|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|12 hours Post-First Dose|MITT population||subjects|||Number
148109|NCT00402987|Other Pre-specified|Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose|Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.|2 and 6 hours Post-First Dose|MITT population||subjects|||Number
148110|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline.|12 hours Post-First Dose|MITT population||subjects|||Number
148111|NCT00402987|Other Pre-specified|Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose|>= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline.|2 and 6 hours Post-First Dose|MITT population||subjects|||Number
148112|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population Comparison Celecoxib 100mg/50mg - Placebo: the NNT value was non-estimable||subjects|||Number
148113|NCT00402987|Other Pre-specified|Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population||subjects|||Number
148114|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|12 hours Post-First Dose|MITT population||subjects|||Number
148115|NCT00402987|Other Pre-specified|Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.|6 hours Post-First Dose|MITT population||subjects|||Number
148116|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|12 and 24 hours Post-First Dose|"Subjects evaluated at 24 hours: 84 for 50mg/50mg; 43 for 100mg/Placebo; 44 for 100mg/50mg; 81 for Placebo.~MITT population"||scores on a scale||Standard Error|Least Squares Mean
148117|NCT00402987|Other Pre-specified|Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose|TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).|2 and 6 hours Post-First Dose|"Subjects evaluated at 6 hours: 85 for 50mg/50mg; 87 for 100mg (pooled); 85 for Placebo.~MITT population"||scores on a scale||Standard Error|Least Squares Mean
148118|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline.|At 12 Hours|MITT population||subjects|||Number
148150|NCT00402740|Secondary|Procedural Success|Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.|30 Days|ITT||percentage of participants||95% Confidence Interval|Number
148119|NCT00402987|Other Pre-specified|Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose|Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline.|At 6 hours|MITT population||subjects|||Number
148120|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
148121|NCT00402987|Other Pre-specified|Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
148122|NCT00402987|Other Pre-specified|Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline.|Over 2 hour Period Post-First Dose|MITT population||units on a scale * hours||Standard Error|Least Squares Mean
148123|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"||units on a scale||Standard Error|Least Squares Mean
148124|NCT00402987|Other Pre-specified|Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose|The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"||units on a scale||Standard Error|Least Squares Mean
148125|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|7 to 24 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
148126|NCT00402987|Other Pre-specified|Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose|The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.|Within 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population~At 15min the SE was <0.01 for all 3 groups"||units on a scale * hours||Standard Error|Least Squares Mean
148127|NCT00402987|Other Pre-specified|Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose|SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline.|2 hour period Post-First Dose|MITT population||units on a scale * hours||Standard Error|Least Squares Mean
148128|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours post-first dose|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"||scores on a scale||Standard Error|Least Squares Mean
148129|NCT00402987|Other Pre-specified|Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose|The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.|Within first 6 hours post-first dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"||scores on a scale||Standard Error|Least Squares Mean
148130|NCT00402987|Secondary|Patient’s Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|12 and 24 hours Post-First Dose|"Subjects analyzed at 24 hours were different for 2 groups: Celecoxib 100mg/Placebo=45 and Placebo=87.~MITT population"||subjects|||Number
148131|NCT00402987|Secondary|Patient’s Global Evaluation of Study Medication at 6 Hours Post-First Dose|Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)|6 Hours Post-First Dose|MITT population||subjects|||Number
148132|NCT00402987|Secondary|Time to Onset of Analgesia|Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.~The median time to onset of analgesia, including all subjects, was >2 hours in each group (time was censored at 2 hours).~Median time and CI were not estimable."||subjects|||Number
148133|NCT00402987|Secondary|Time to Meaningful Pain Relief|The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported|Within 2 Hours Post-First Dose|"MITT population.~The median time to meaningful pain relief, including all subjects, was >2 hours in each group (time was censored at 2 hours)~Median time and CI were not estimable"||subjects|||Number
148134|NCT00402987|Secondary|Time to Perceptible Pain Relief|Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug|Within 2 Hours Post-First Dose|"MITT population.~Number of Subjects achieving perceptible pain relief: 77 for celecoxib 50mg/50mg; 67 for celecoxib 100mg (pooled); 46 for placebo~Upper 95% CI for placebo group was >120"||minutes||95% Confidence Interval|Median
148135|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 12 Hours Post-First Dose|Subjects Achieving at Least ‘Moderate Relief’ as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|12 hours|MITT population||subjects|||Number
148136|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) - ‘Moderate Relief’ at 6 Hours Post-First Dose|Subjects Achieving at Least ‘Moderate Relief’ as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).|at 6 hours|MITT population||subjects|||Number
148137|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"||scores on a scale||Standard Error|Least Squares Mean
148138|NCT00402987|Secondary|Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose|STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.|within the first 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"||scores on a scale||Standard Error|Least Squares Mean
148139|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
148140|NCT00402987|Secondary|Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose|The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.|up to 6 hours|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"||units on a scale * hours||Standard Error|Least Squares Mean
148141|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.|7 to 24 hours|"Subjects evaluated at each timepoint varied from: 85-80 for 50mg/50mg; 43-39 for 100mg/Placebo; 44-43 for 100mg/50mg; 82-73 for Placebo.~MITT population"||units on a scale||Standard Error|Least Squares Mean
148142|NCT00402987|Secondary|Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose|Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Within First 6 hours Post-First Dose|"Subjects evaluated at each timepoint varied from: 90-85 for 50mg/50mg; 90-87 for 100mg (pooled); 89-85 for Placebo.~MITT population"||units on a scale||Standard Error|Least Squares Mean
148143|NCT00402987|Primary|Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose|Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.|2 hours Post-First Dose|Modified intent-to-treat (MITT) population, defined as all subjects randomized to treatment who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. The celecoxib 100mg (pooled) treatment group and placebo were compared for the primary endpoint. Celecoxib 50mg/50mg group was not in this analysis.||units on a scale * hours||Standard Error|Least Squares Mean
148144|NCT00402896|Primary|Median Time to Pleurodesis|Time to pleurodesis from initiation of treatment to catheter removal as measure of pleural effusion Improvement (amount of pleural fluid drainage) where objective was to examine whether ZD6474 would help participants to improve the condition of pleural effusion, and thus remove the catheter earlier. Cox model analysis applied to examine the effect of covariates on the time to catheter removal.|Time from initiation of treatment and catheter insertion up to a maximum of 10 weeks|Twenty eligible participants were analyzed for the primary outcome in the trial, eleven completed 10 weeks of treatment. All twenty participants completed the study.||Days||95% Confidence Interval|Median
148145|NCT00402883|Secondary|Overall Survival||18 months||||||
148146|NCT00402883|Secondary|To Evaluate the Objective Response Rates||18 months||||||
148147|NCT00402883|Primary|Time to Progression||18 months|No patients were analyzed due to the fact that the study ended early because of the formation of tracheoesophageal fistulas.|||||
148148|NCT00402740|Secondary|Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.||3 years|ITT||Event-free percentage|||Number
148149|NCT00402740|Secondary|Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax|Includes only each subject's first occurrence of each event.|≤30 days|ITT||percentage of participants||95% Confidence Interval|Number
148152|NCT00402740|Primary|Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.|Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.|3 years|Intent to Treat (ITT)||Event-free percentage|||Number
148153|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.||percentage of participants|||Number
148154|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms|BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.|14 - 28 days after last dose of study medication|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.||percentage of participants|||Number
148155|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.||percentage of participants|||Number
148156|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the ITT Population With Causative Organisms|Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.|after 7 - 21 days of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.||percentage of participants|||Number
148157|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from “indeterminate”.||percentage of participants|||Number
148158|NCT00402727|Secondary|Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms|Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.|3 - 5 days after start of treatment|The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.||percentage of participants|||Number
148159|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population|Clinical response was evaluated by the investigator and graded as “resolution”, or “failure to respond,” or “indeterminate” at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|after 7 - 21 days of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.||percentage of participants|||Number
148160|NCT00402727|Secondary|Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population|Clinical response was evaluated by the investigator and graded as “resolution,” or “failure to respond,” or “indeterminate” at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|after 7 - 21 days of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.||percentage of participants|||Number
148177|NCT00402649|Secondary|Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers|Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants||Titer||95% Confidence Interval|Geometric Mean
148178|NCT00402649|Secondary|Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater|Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants||Participants|||Number
148161|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population|Clinical response was evaluated by the investigator and graded as “improvement in signs and symptoms,” or “failure to respond,” or “indeterminate” at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs|3 - 5 days after start of treatment|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.||percentage of participants|||Number
148162|NCT00402727|Secondary|Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population|Clinical response was evaluated by the investigator and graded as “improvement in signs and symptoms,” or “failure to respond,” or “indeterminate” at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|3 - 5 days after start of treatment|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.||percentage of participants|||Number
148163|NCT00402727|Secondary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population|Clinical response was evaluated by the DRC and graded as “cure”, “failure” or “indeterminate” at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|14 - 28 days after last dose of study medication|The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as all randomized subject that received at least one dose of study medication and had at least one observation after intake of study drug.||percentage of participants|||Number
148164|NCT00402727|Primary|Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population|Clinical response was evaluated by the DRC and graded as “cure”, “failure” or “indeterminate” at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.|14 - 28 days after last dose of study medication|The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.||percentage of participants|||Number
148165|NCT00402714|Secondary|Overall Survival||2 years following stem cell transplant|||participants|||Number
148166|NCT00402714|Primary|Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis||Day +100 following allogeneic stem cell transplant|||participants|||Number
148167|NCT00402688|Secondary|Total NIH-CPSI Score|National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life).|Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)|Modified Intent to Treat (mITT)||Score on a scale||Full Range|Mean
148168|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone Contact at 6 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)||Participants|||Number
148169|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 3 Months|Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)||Participants|||Number
148170|NCT00402688|Secondary|Clinical Success (Non-Relapse) or Failure (Relapse)|Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit|Poststudy Telephone contact at 6 weeks|Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit)||participants|||Number
148171|NCT00402688|Secondary|Symptom Relief (Resolved)|Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)||Participants|||Number
148172|NCT00402688|Primary|Clinical Success|Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.|Posttherapy Visit (Study Day 33-36)|Modified Intent to Treat (mITT)||Participants|||Number
148173|NCT00402649|Primary|Occurrence of Serious Adverse Events|Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.|6 months after the first vaccination|||Participants|||Number
148174|NCT00402649|Primary|Occurrence of Unsolicited Adverse Events|Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.|Through Day 28 after second vaccination|||Participants|||Number
148175|NCT00402649|Primary|Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10|Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.|Days 0-7 post each vaccination|Solicited symptom of Body Aches was collected from subjects age 6-10 only||Participants|||Number
148176|NCT00402649|Secondary|Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers|Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine.|Day 28 after second vaccination|Blood draw was optional - blood collected from 16 participants post vaccination, but missing baseline assessment for 3 of 16 subjects||Participants|||Number
158538|NCT00303862|Secondary|KDR|Kinase insert domain-containing vascular endothelial growth factor receptor|Day 28 after initiation of therapy|Because trial was closed due to poor accrual, assays were not performed.|||||
148179|NCT00402649|Primary|Occurrence of Solicited Adverse Events Among All Subjects|Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.|Days 0-7 post each vaccination|||Participants|||Number
148180|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.||Patients|||Number
148181|NCT00402597|Secondary|The Number of Deaths (All Cause)|The number of patients who died due to any cause from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.||Patients|||Number
148182|NCT00402597|Secondary|The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke|The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment regardless of study drug intake.||Patients|||Number
148183|NCT00402597|Secondary|The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke|The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The ITT population consisted of all patients who were randomized to treatment, regardliess of study drug intake.||Patients|||Number
148184|NCT00402597|Primary|The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)|The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.|Day 1 to Day 210|The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake.||Patients|||Number
148185|NCT00402597|Primary|Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)|The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.|Day 1 to Day 210|The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.||Patients|||Number
148186|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.||recurrences||Inter-Quartile Range|Median
148187|NCT00402363|Secondary|Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period|Values were annualized by counting the number of episodes of symptomatic AF/flutter recurrences (maximum of one per day), dividing by the number of days on treatment, then multiplying this number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants with an event.||recurrences||Inter-Quartile Range|Median
148188|NCT00402363|Secondary|Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period|Rescue was defined as any pharmacological/electrical/surgical intervention for the termination/prevention of AF/flutter with a maximum of one rescue episode counted per day. Note: all annualized values were calculated by counting the number of rescue episodes, dividing by the number of days on treatment, then multiplying that number by 365.25.|From first dose of study drug (Day 1) to the last dose of study drug (up to Week 24)|MITT Population. The number analyzed represents those participants who had a rescue episode.||rescue episodes||Inter-Quartile Range|Median
148189|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
148190|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
148191|NCT00402363|Secondary|Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
148192|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF/flutter."|From completion of Day 7 of study drug to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population. Participants with events that occurred in the first 7 days were excluded from analysis.||participants|||Number
148193|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
148194|NCT00402363|Secondary|Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)|"A documented episode of symptomatic or asymptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF were recorded by TTM during routine bi-weekly transmissions. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
148195|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population||participants|||Number
148196|NCT00402363|Secondary|Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter|"A documented episode of symptomatic or asymptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Asymptomatic episodes of AF or flutter were recorded by TTM during routine bi-weekly transmissions. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. Censored in the table below refers to participants who did not have a documented episode of symptomatic or asymptomatic AF/flutter."|From first dose of study drug (Day 1) to the first symptomatic or asymptomatic recurrence of AF/flutter (up to Week 24)|MITT Population||participants|||Number
148197|NCT00402363|Secondary|Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
148198|NCT00402363|Secondary|Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)|"A documented episode of symptomatic AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF (up to Week 24)|MITT Population||participants|||Number
148199|NCT00402363|Secondary|Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter|"A documented episode of symptomatic AF/flutter was defined as AF/flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|MITT Population||participants|||Number
148200|NCT00402363|Primary|Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter|"A documented episode of symptomatic AF /Flutter was defined as AF/Flutter documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF. Atrial flutter, a closely related rhythm disorder, was distinguished from AF by the presence of distinctive flutter p-waves at regluar intervals. The occurrence of symptomatic atrial flutter was treated as an occurrence of symptomatic AF for this outcome measure. Censored in the table below refers to participants who did not have a documented episode of symptomatic AF or flutter."|From first dose of study drug (Day 1) to the first symptomatic recurrence of AF/flutter (up to Week 24)|Modified Intent-to-Treat (MITT) Population: all randomized participants who provided at least one post-randomization TTM ECG data transfer or equivalent||participants|||Number
148214|NCT00402324|Secondary|Number of Patients Hospitalized Due to Relapse of Mania or Depression.|Number of participants hospitalized as a result of relapse of mania or depression.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients.||participants|||Number
148201|NCT00402337|Secondary|Change From Baseline in Straining Score for the Treatment Period|Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis."||units on a scale||Standard Error|Least Squares Mean
148202|NCT00402337|Secondary|Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period|Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid.|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis."||units on a scale||Standard Error|Least Squares Mean
148203|NCT00402337|Secondary|Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period|CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."||CSBMs per week||Standard Error|Least Squares Mean
148204|NCT00402337|Secondary|CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks.~For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."||participants|||Number
148205|NCT00402337|Secondary|SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)|"A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks.~For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate."|Change from Baseline to Week 4|"307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population."||participants|||Number
148206|NCT00402337|Primary|Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency|Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.|Change from Baseline to Week 4|307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 “How many bowel movements did you have today or yesterday since your last call?” were included in the intent-to-treat (ITT) Population.||SBMs per week||Standard Error|Least Squares Mean
148207|NCT00402324|Secondary|Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)|Percentages of participants in each group who experienced an increase in weight of at least 7% from baseline to endpoint.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||percentage of participants|||Number
148208|NCT00402324|Secondary|Clinically Significant Vital Signs - Weight Change From Baseline|Change from baseline to endpoint: Value of weight measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||kilograms||Standard Error|Least Squares Mean
148209|NCT00402324|Secondary|Clinically Significant Vital Signs - Body Mass Index Change From Baseline|Change from baseline to endpoint in body mass index (an estimate of body fat derived by dividing body weight by height squared): Value of body mass index measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||kilograms per square meters||Standard Error|Least Squares Mean
148210|NCT00402324|Secondary|Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline|Change from baseline to endpoint in bilirubin total: Value of bilirubin total measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
148211|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline|Change from baseline to endpoint in fasting blood glucose: Value of fasting blood glucose measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||milligrams per deciliter||Standard Deviation|Mean
148212|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline|Change from baseline to endpoint in triglycerides: Value of triglyceride measure at endpoint minus value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||milligrams per deciliter||Standard Deviation|Mean
148213|NCT00402324|Secondary|Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline|Change from Baseline to endpoint in cholesterol: value of cholesterol measure at endpoint minus the value at baseline.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and at least one post-baseline measure. Intention to Treat analysis.||milligrams per deciliter||Standard Deviation|Mean
148215|NCT00402324|Secondary|Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint|CGI-BP Severity is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (6 weeks)|Intent to Treat analysis. Number of randomized patients with baseline and at least one nonmissing postbaseline value. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
148216|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Response|The original outcome measure was Time to Mixed Response(at least a 50% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||participants|||Number
148217|NCT00402324|Secondary|Number of Participants Meeting the Criteria for Mixed Onset of Action|The original outcome measure was Time to Mixed Onset of Action (at least a 25% reduction on HAMD and YMRS total scores from baseline); however since upper limit of measure of dispersion could not be computed by observed data, which is not allowed on this system, number of patients with event are presented instead.|Baseline to endpoint (6 weeks)|All randomized participants with both baseline and post-baseline measures. Intention to Treat analysis.||participants|||Number
148218|NCT00402324|Primary|Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.|The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.||units on a scale||Standard Error|Least Squares Mean
148219|NCT00402324|Primary|Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline to endpoint (6 weeks)|Intent to Treat analysis. All randomized patients with baseline & at least one post-baseline measure.||units on a scale||Standard Error|Least Squares Mean
148220|NCT00402285|Primary|Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2|Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.|baseline through 3 month|1 ppt randomized to fish oil had un-evaluable COX-2 at 3 months.||fold change||Standard Deviation|Mean
148221|NCT00402246|Secondary|In-office Follow-up Burden: Hours Absent From Work Due to Visit|Subjects were asked at their one month visit to indicate on a survey how many hours of work they were missing to attend that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.||Hours||Standard Deviation|Mean
148222|NCT00402246|Secondary|In-office Follow-up Burden: Patient Expenses|On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.|1 month|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.||Dollars||Standard Deviation|Mean
148223|NCT00402246|Secondary|In-office Follow-up Burden: Distance Traveled|Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.|1 month visit|All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.||Miles||Standard Deviation|Mean
148224|NCT00402246|Secondary|Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).|Following the completion of enrollment in the study, participating clinicians were asked to complete a survey assessing their overall satisfaction with the wireless telemetry feature. Clinicians' rating (1=strongly disagree, 5=strongly agree) of the overall satisfaction with the wireless telemetry feature of the device|After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject|All surveys in which clinician completed at least a subset of the questions were included.||Units on a scale||Standard Deviation|Mean
148225|NCT00402246|Secondary|Trait-Anxiety Scale|The Trait-Anxiety scales for each subject were obtained at multiple time points. The Trait-Anxiety scale was derived by summing the 20 scores in the Trait section of the STAI questionnaire. The Trait-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.||Scores on a scale||Standard Deviation|Mean
148226|NCT00402246|Secondary|State-Anxiety Scale|The State-Anxiety scales for each subject were obtained at multiple time points. The State-Anxiety scale was derived by summing the 20 scores in the State section of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).|1, 3, 6, 9, 12, and 15 month visit|All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.||Scores on a scale||Standard Deviation|Mean
148227|NCT00402246|Secondary|Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)|"LV Capture Threshold is the required energy(volts) necessary to cause the left ventricule to contract. It is important that a device which paces the left ventricule be set to a threshold such that current conducted through the left ventricular lead will induce contraction in the left ventricle. However, these thresholds may vary over time.~The standard deviation and range (maximum LVCM threshold - minimum LVCM threshold) of the most recent 14 days of LVCM results prior to each follow-up visit were determined for each subject and used to assess within-patient variability in LV thresholds."|1, 3, 6, 9, 12, and 15 months visits|All enrolled subjects who were implanted with a Concerto CRT-D (Cardiac Resynchronization Therapy with Defibrillation)device, met inclusion/exclusion criteria, and had daily LVCM measurement for at least one of the 6 scheduled visits/transmissions were included in the analysis.||Volts||Standard Deviation|Mean
148228|NCT00402246|Secondary|CareLink Transmission Compliance|The CareLink Transmission Compliance Rate for a particular visit (e.g. 3 month visit) is the proportion (ranging from 0 to 1) of subjects with device interrogation data remotely transmitted via the CareLink system on the date it was scheduled to be sent for that visit. The proportion is a fraction in which the denominator is the number of subjects in the Remote Arm who were not exited from the trial prior to the visit of interest, and the numberator is the number of Remote Arm subjects who successfully transmitted device data via the CareLink system on the date it was scheduled to be sent.|3, 6, 9, 12 months visits|9 of 1014 remote arm subjects did not meet the inclusion/exclusion criteria and were excluded from the analysis. The remaining 1005 remote arm subjects were included in the analysis.||Proportion of subjects||95% Confidence Interval|Mean
148229|NCT00402246|Other Pre-specified|Length of Hospital Stay (LOS)|LOS per cardiovascular hospitalization|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis.||Days||Standard Error|Mean
148230|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations|Days from device detection of a clinical event or a symptom-driven device interrogation event onset to a clinical decision, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event is an event as defined in the primary objective. A symptom-driven device interrogation event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|From event onset to clinical decision|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.||Days||Standard Deviation|Mean
148231|NCT00402246|Secondary|Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations|Days from a symptom-driven device interrogation event onset to a clinical decision being made in response to the event as reported by the clinician. An event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.||Days||Standard Deviation|Mean
148232|NCT00402246|Secondary|AT/AF Alert Treatment|Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who had at least one AT/AF alert were included in the analysis.||Alerts|Participants||Number
148233|NCT00402246|Secondary|Symptomatic AT/AF Alerts|AT/AF represents atrial tachycardia or atrial fibrillation which are arrhythmias involving rapid beating of the atrial chambers of the heart. The devices in this study store how many hours each day that a patient experiences AT/AF. The patient may not be aware they are experiencing these atrial arrhythmias, but if the AT/AF is accompanied by symptoms, the AT/AF is said to be symptomatic AT/AF. Devices in this study have an alert that fires if the patient experiences at least a programmed amount of AT/AF in a day. Measure is count of symptomatic AT/AF alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote patients who experienced at least one AT/AF alert were included in the analysis. AT/AF alerts there were not classified by the clinician as symptomatic or asymptomatic were excluded from the analysis.||Alerts|Participants||Number
148234|NCT00402246|Secondary|Clinically Meaningful Alerts|Count of clinically meaningful alerts as classified by the clinician|Enrollment to last visit (up to 15 month post-implant)|All enrolled remote subjects who experienced at least one alert were included in the analysis. Alerts that were not classified by the clinician as clinically meaningful or not were excluded from the analysis.||Alerts|Participants||Number
148235|NCT00402246|Secondary|Actions Taken for HCU Visits|Count of HCU visits that involved specific actions taken|Enrollment to last visit (up to 15 month post-implant)|||Visits|||Number
148236|NCT00402246|Secondary|Health Care Utilization: TEEs|Count of Transesophageal echocardiograms (TEEs) performed|Enrollment to last visit (up to 15 months post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.||Procedures|||Number
148237|NCT00402246|Secondary|Health Care Utilization (HCU)|Count of HCU visits for each HCU type (cardiovascular (CV) hospitalizations, cardiovascular (CV) emergency department (ED), and cardiovascular (CV) unscheduled clinic office/urgent care visits)|Enrollment to last visit (up to 15 month post-implant)|9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.||Visits|||Number
148238|NCT00402246|Primary|Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues|Days from device detection of a clinical event to a decision being made in response to the event, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event could be any of the following that satisfied pre-specified thresholds: arrhythmias (e.g. at least 12 hours of atrial tachycard/atrial fibrillation in a day), cardiovascular disease progression (e.g. multiple device shocks delivered to terminate a single episode), or device issues (e.g. low battery).|Enrollment to last visit (up to 15 month post-implant)|All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. An intention to treat analysis was performed for this objective.||days||Inter-Quartile Range|Median
148239|NCT00402233|Secondary|Beck Depression Inventory II|Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
148240|NCT00402233|Secondary|Epworth Sleepiness Scale|Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
148241|NCT00402233|Secondary|Modified Hoehn and Yahr Stage|Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
148242|NCT00402233|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)|From baseline to week 12|Treated set||units on a scale||Standard Deviation|Mean
148243|NCT00402194|Primary|Insulin-stimulated Leg Glucose Uptake||3 months|||mmol/min||Standard Deviation|Mean
148244|NCT00402194|Primary|Leg Blood Flow Response to Insulin||3 months|||Liters/minute||Standard Deviation|Mean
148245|NCT00402168|Secondary|Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Day of Switch = the first belatacept infusion day.|Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized.||participants|||Number
148246|NCT00402168|Secondary|Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch|Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Day of Switch = the first belatacept infusion day.|Day of Switch (first belatacept dose) to Week 96 Post Switch|All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized. n=number of participants with data available at specific time point||mL/min/1.73 m^2||Standard Deviation|Mean
148247|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in mmHg. Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||mmHg||Standard Deviation|Mean
148248|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure|Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was value at screening. Only those participants who entered long term period were evaluated.|Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||mmHg||Standard Deviation|Mean
148249|NCT00402168|Secondary|Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period|Upper limits of normal (ULN). Hemoglobin: < 8 g/dL; Platelet count: < 50*10^9 c/L; Leukocytes: < 2.0*10^3 c/µL; Lymphocytes (absolute): < 0.5*10^3 c/µL; Neutrophils: < 1.0*10^3 c/µL; Alanine Aminotransferase (ALT): > 5.0*ULN Units per liter (U/L); bilirubin: > 3.0*ULN mg/dL; Creatinine: > 3.0*ULN mg/dL; Calcium: < 7 mg/dL; Bicarbonate: > 12.5 mg/dL; Potassium: < 3.0 meq/L or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL.|Baseline (Screening), up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||participants|||Number
148250|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period|Baseline was value at screening. Serum creatinine was measured in mg/dL. Only participants who entered into Long Term Period were included in the analysis.|Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.||mg/dL||Standard Deviation|Mean
148251|NCT00402168|Secondary|Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections, Thrombolic/embolic events, Autoimmune Disease, Malignancy, Peri-infusional reactions (only belatacept treatment group was IV) , Acute Peri-infusional events occurring within 24 hours of injection, Pulmonary Edema and Congestive Heart Failure. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
148268|NCT00402168|Secondary|Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization|Graft loss was defined as either functional loss or physical loss. Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation.|At 6 and 12 months post randomization|All participants who were randomized were summarized.||percentage of participants|||Number
148252|NCT00402168|Secondary|Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study|All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
148253|NCT00402168|Secondary|Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Baseline (screening) up to Month 36 post randomization|Participants without pre-randomization diabetes, who were randomized and entered LT Period.||percentage of participants||95% Confidence Interval|Number
148254|NCT00402168|Secondary|Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period|Graft loss = either pure graft loss (participant survived to the end of the study period after graft loss) or death with functioning graft. Pure graft loss = either functional loss or physical loss. Functional loss = a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation. The table was designed with built-in redundancy to capture all possible combinations of death and/or graft loss, but not all lines can be summed to reach the total number surviving and the total number who die and/or lose grafts. If a participant experiences pure graft loss and dies at a later date independent of the graft loss event, they are counted only once in the cumulative tabulation of death or graft loss. Only the first event experienced by the participant counted toward the cumulative total.|Post Months 24, 36, 48, up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
148255|NCT00402168|Secondary|Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period|AR was defined: if either a or b was satisfied: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 working classification of kidney transplant pathology was used to categorize the severity of the AR.|Post Month 12 up to Year 6 of the Study|Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||participants|||Number
148256|NCT00402168|Secondary|Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period|ITT=participants randomized to their original treatment arm and who entered the LT period are presented. Baseline=value at screening. Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value of 0 was imputed and carried forward after death or graft loss up to the end of the analysis period. Sponsor discontinued the CNI treatment arm in Year 3, and participants treated with CNI could elect to switch to belatacept. If a participant did not switch to belatacept, they were required to discontinue from the study. Therefore, efficacy results from Month 36 through Month 54 are difficult to interpret. No formal comparisons were planned between the belatacept and CNI treatment groups post Month 36, and the data up to the final database lock should be interpreted with caution.|Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54|Participants randomized to their original treatment arm who entered the LT Period (ITT - LT) and had data at baseline and at specific timepoints . Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).||mL/min/1.73 m^2||Standard Deviation|Mean
148257|NCT00402168|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants|Upper limits of normal (ULL). Leukocytes: < 2.0*10^3 cells per microliter (c/µL); Lymphocytes (absolute): < 0.5*10^3 c/µL; bilirubin: > 3.0*ULN milligrams per deciliter (mg/dL); Potassium: < 3.0 milliequivalents per liter (meq/L) or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL. Baseline = value at screening.|Baseline up to Month 12|All randomized participants who received at least one dose of study drug and had a laboratory value available post randomization. N= number of participants analyzed in all categories||participants|||Number
148266|NCT00402168|Primary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.|Baseline to 12 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.||mL/min/1.73 m^2||Standard Deviation|Mean
148258|NCT00402168|Secondary|Ridit Score at Month 12 - All Randomized Participants|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at 12 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Month 12|All randomized participants with MTSOSD-59R data were analyzed.||Ridit score|||Number
148259|NCT00402168|Secondary|Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants|"SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 8 domains of physical and mental component summaries: physical function, role limitations due to physical problems, pain, general health perception, and vitality, social function, role limitations due to emotional problems, and mental health.~All domains were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life."|Baseline (screening) to Month 12|Randomized participants with available questionnaires were analyzed.||units on a scale||Standard Error|Mean
148260|NCT00402168|Secondary|Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire. The subscale in the mental component (MCS) part of the instrument ranged from 1 to 6 with 1=all of the time and 6= none of the time. The subscale for physical component (PCS) ranged from 1 to 3 with 1=Yes, limited a lot and 3=No, not limited at all. The subscale for the extent that physical health or emotional problems interfered with normal activities ranged from 1 to 5 with 1=not at all and 5= extremely. Baseline was at randomization or prior to first dose. Baseline = value at screening. The subscale scores were transformed using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.|Baseline, Month 12|All randomized participants who completed the questionnaire at baseline and at Month 12.||units on a scale||Standard Error|Mean
148261|NCT00402168|Secondary|Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|First Dose (Day 1) to Month 12|All randomized participants who received at least 1 dose of study drug were summarized.||participants|||Number
148262|NCT00402168|Secondary|Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants|Baseline was value at screening or prior to first dose of study drug. Serum creatinine was measured in milligrams per deciliter (mg/dL). Baseline = value at screening.|Baseline to Month 6 and Month 12 Post Randomization|All randomized participants with baseline and laboratory value at specific time point were summarized.||mg/dL||Standard Deviation|Mean
148263|NCT00402168|Secondary|Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies|Samples were obtained at Day 1 (first dose), Week 24, and Week 52 (or end of therapy). This was a cumulative summary in that once a participant was positive, that participant remained positive for later time points. Evaluation of anti-donor HLA antibodies was performed by an external laboratory (Emory University, Atlanta, Georgia).|Month 6 and Month 12 Post Randomization|Participants who had at least one test result or finding were summarized. n=number of participants analyzed at each specific time point.||participants|||Number
148264|NCT00402168|Secondary|Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants|A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.|Month 12 post randomization|Participants without pre-randomization diabetes.||percentage of participants||95% Confidence Interval|Number
148265|NCT00402168|Secondary|Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12|Percentage=number with composite divided by number randomized. Graft loss was functional loss or physical loss. Functional loss = sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that participant undergoes re-transplantation. AR: if either a or b: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy-proven AR (grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy-proven AR, and the participant was treated for it.|12 Months post randomization|All participants who were randomized were analyzed.||percentage of participants||95% Confidence Interval|Number
148267|NCT00402168|Secondary|Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants|Reasons for study drug dose modification included categories of decline in renal function (as determined by the investigator), treatment of acute rejection, and other reasons. More than 1 reason could be given for dose alteration.|Month 12|Participants who were randomized and received at least one dose of any study drug.||participants|||Number
148269|NCT00402168|Secondary|Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants|AR defined: if either a or b was satisfied: a: the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification Grade IA or higher as assessed by the blinded central pathologist); b: the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection.|At 6 and 12 months post randomization|ITT population: All randomized participants were summarized. N=number analyzed for Months 6 and 12||participants|||Number
148270|NCT00402168|Secondary|Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)|Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening.|Baseline to 6 months post randomization|Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.||mL/min/1.73 m^2||Standard Deviation|Mean
148271|NCT00402103|Secondary|Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.||Percentage of patients|||Number
148272|NCT00402103|Secondary|Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg||Baseline, Week 2, Week 10, Week 28 and Week 54|Treated Population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.||Percentage of patients|||Number
148273|NCT00402103|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points||Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54|Treated population, Last observation carried forward (LOCF). Total combined treated patients are 556 out of which 470 patients are treated with Aliskiren and Amlodipine combination only and 86 patients are treated with Ali/Amlo/HCTZ combination.||mm Hg||Standard Deviation|Mean
148274|NCT00402103|Primary|Overall Percentage of Patients With Adverse Events||52 weeks|Treated Population||Percentage of Participants|||Number
148275|NCT00402051|Secondary|Pharmacology Toxicities|Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.|Every 21-day cycle for up to 6 cycles|Full Analysis Set: All patients randomized who received at least one dose of study drug||participants|||Number
148276|NCT00402051|Secondary|Time to Treatment Failure (TTF)|Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first|Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug||months||95% Confidence Interval|Median
148277|NCT00402051|Secondary|Number of Participants With Tumor Response (as Basis for Response Rate)|"Best overall response was evaluated using RECIST Criteria which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage."|Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression|Full Analysis Set: All patients randomized who received at least one dose of study drug||participants|||Number
148278|NCT00402051|Secondary|Overall Survival|Defined as the time from randomization to the date of death from any cause.|Randomization to date of death from any cause (up to 1 year)|Full Analysis Set: All patients randomized who received at least one dose of study drug||months||95% Confidence Interval|Median
148279|NCT00402051|Primary|Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)|For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 * exp(-6 λ) * (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln[ r / ∑ti ] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.|Randomization to Month 6|Full Analysis Set: All patients randomized who received at least one dose of study drug||percentage|||Number
148280|NCT00402025|Secondary|Change From Baseline in Pain Intensity|Pain was assessed by the participant using a validated Visual Analog Scale (VAS) pain assessment instrument. A single 10-cm line was used with the leftmost end (0 cm) representing “no pain” and the rightmost end (10 cm) representing “worst pain”. The distance was measured from the leftmost part of the scale to the mark made by the participant indicating pain level.|Baseline and Weeks 3 and 6|ITT population with available VAS data; this assessment was added in the third protocol amendment and change from baseline could only be assessed for participants in cohort 3.||cm||Standard Deviation|Mean
148281|NCT00402025|Primary|Number of Participants Positive for Anti-herpes Simplex Virus-1 (HSV-1) Antibodies|Anti-HSV-1 antibodies were detected using an enzyme-linked immunosorbent assay (ELISA).|Week 0 (Day 1, predose) and Week 3|ITT population with available antibody results (indicated by N)||participants|||Number
148282|NCT00402025|Primary|Number of Participants With Talimogene Laherparepvec Detected in Blood and Urine|Samples of blood and urine collected before and up to 24 hours after dosing were tested for the presence of talimogene laherparepvec deoxyribonucleic acid (DNA) using a validated quantitative polymerase chain reaction (qPCR) assay.|Treatment Day 1 predose and 2, 6, 12 and 24 hours postdose, and Week 3 and 6 at (predose and 2 hours postdose.|ITT population||participants|||Number
148283|NCT00402025|Secondary|Number of Participants With Overall Objective Response|"Tumor response was assessed via CT scan by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 guidelines. Objective response is defined as a complete response (CR) or partial response (PR).~CR: Disappearance of all target and non-target lesions, normalization of tumor marker level and no new lesions and with confirmation no less than 4 weeks after the criteria for CR is first met.~PR: At least a 30% decrease in the sum of longest diameters of target lesions taking as reference the baseline sum of the longest diameters, absence of non-target lesion progression, and no new lesions. These criteria must be confirmed no less than 4 weeks after they are first met."|Every 6 weeks until 12 weeks after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population||participants|||Number
148284|NCT00402025|Secondary|Change From Baseline in Sum of Longest Diameters of Injected Tumors|Spiral computed tomography (CT) scans were performed to assess tumors at screening and at Weeks 6, 12 and 18 after the initial dose.|Baseline and Week 6, 12 and 18|"ITT population with available data at each time point (indicated by N)."||mm||Standard Deviation|Mean
148285|NCT00402025|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important and significant medical event that, based upon appropriate medical judgment, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.|From first dose of talimogene laherparepvec until 30 days after the last dose; the median duration of treatment was 44.0 days, 22.0 days, and 11.5 days in each group respectively.|ITT population||participants|||Number
148286|NCT00401973|Secondary|Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks|To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.|Baseline to endpoint (22 weeks)|N=Pairs of Observations for the combined treatment groups.||correlation|||Number
148287|NCT00401973|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.||units on a scale||Standard Deviation|Mean
148288|NCT00401973|Secondary|Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.||units on a scale||Standard Deviation|Mean
148289|NCT00401973|Secondary|Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.|Baseline to endpoint (22 weeks)|Number of participants with a baseline and at least one post baseline measurement. Last post-baseline measurement carried forward.||units on a scale||Standard Deviation|Mean
148290|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Hemoglobin A1c||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||percent hemoglobin A1c||Standard Deviation|Mean
148291|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Glucose||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
148292|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
148293|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol||Baseline to endpoint (22 weeks)|Number of randomized participants with a baseline and at least one post-baseline measurement. Last post-baseline measurement carried forward.||millimole per liter (mmol/L)||Standard Deviation|Mean
148294|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Total Cholesterol||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimole per Liter (mmol/L)||Standard Deviation|Mean
148295|NCT00401973|Secondary|Mean Change From Baseline to Endpoint in Fasting Triglycerides||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement. Last post-baseline measurement carried forward.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
148296|NCT00401973|Primary|Change From Baseline to Endpoint in Weight||Baseline to endpoint (22 weeks)|All randomized participants with baseline and at least one postbaseline measurement.||kilograms||Standard Error|Least Squares Mean
148297|NCT00401843|Primary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|up to 5 years|The safety population included all participants who received at least 1 dose of study treatment in Part 1 or Part 2. Participants were analyzed as per actual treatment received.||participants|||Number
148298|NCT00401843|Secondary|Overall Survival|Overall survival was defined as the interval between the first administration of study agent or randomization (Part 2) and the participant’s death from any cause. For participants with unknown survival status as of the data cut-off date, overall survival was censored at the last date known to be alive.|up to 5 years|ITT population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.||days||95% Confidence Interval|Median
148299|NCT00401843|Secondary|Percentage of Participants With Confirmed Complete Response (CR Rate)|CR rate was defined as the percentage of participants who achieved a confirmed CR before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.||percentage of participants|||Number
148300|NCT00401843|Secondary|Percentage of Participants With Best Confirmed Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate)|Overall response rate was defined as best response (CR/PR confirmed) for a participant recorded from first administration of study agent or randomization (Part 2) until disease progression/recurrence and before dexamethasone was added. CR: Absence of original M-protein in serum/urine by immunofixation,maintained for minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR; Less than 5 percent (%) plasma cells in bone marrow aspirate and also on trephine bone biopsy if biopsy is performed; No increase in size/number of lytic bone lesions; Disappearance of soft tissue plasmacytomas. PR: Greater than or equal to (>=) 50% reduction in level of serum M-protein, maintained for minimum of 6 weeks. Reduction in 24 hour urinary light chain excretion either by >= 90% or to < 200 mg, maintained for minimum of 6 weeks; >= 50% reduction in size of soft tissue plasmacytomas; No increase in size/number of lytic bone lesions.|Randomization until disease progression (maximum up to 5 years)|Response-evaluable population:all participants in Part 2 with confirmed diagnosis of multiple myeloma and measurable,secretory disease:either serum M-protein 1 >= gram per deciliter(g/dL)/urine M-protein >200 mg per 24 hours,at study entry;had at least 1 study agent administration;at least 1 post-baseline disease assessment before dexamethasone.||percentage of participants|||Number
148301|NCT00401843|Primary|Progression-free Survival|Progression-free survival was defined as the time interval between randomization and the first documented sign of disease progression (including relapse from complete response [CR]) by the European Bone Marrow Transplant (EBMT) criteria or death, whichever occurred first. Relapse from CR requires at least 1 of the following: Reappearance of serum or urinary M-protein on immunofixation or routine electrophoresis, confirmed by at least 1 further investigation and excluding oligoclonal immune reconstitution; Greater than or equal to (>=) 5 percent (%) plasma cells either in a bone marrow aspirate or on trephine bone biopsy; Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression); Development of hypercalcemia not attributable to any other cause.|Randomization until disease progression or death, which ever occured first (maximum up to 5 years)|Intent-to-treat (ITT) population included all participants randomized in Part 2. Participants were analyzed as per initial randomization.||days||95% Confidence Interval|Median
148302|NCT00401830|Secondary|Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12||End of the Maintenance Phase/Week 12|The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.||ug/ML||Standard Deviation|Mean
148303|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase|All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
148304|NCT00401830|Secondary|Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase|Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.||Percentage of patients|||Number
148305|NCT00401830|Secondary|Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase|Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.|12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.||Percentage of patients|||Number
148320|NCT00401778|Primary|Clinical Response as Assessed Metabolically by Changes in Positron Emission Tomography (PET) Scan Between Baseline and Immediately Prior to Surgery.|All patients had baseline imaging in a fasted state with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18FDG)-PET scan and a repeat scan at 3 to 4 weeks later using routine clinical protocol for patient preparation, radiotracer administration and data acquisition. The repeat imaging occurred no longer than 24 hours before surgical resection.|Day 21|||percentage of patients|||Number
148306|NCT00401830|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase|The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.||Score on a scale||Standard Deviation|Mean
148307|NCT00401830|Secondary|Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase|The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.||Patients|||Number
148308|NCT00401830|Secondary|Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
148309|NCT00401830|Secondary|Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase|An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12 week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
148310|NCT00401830|Secondary|Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase|General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
148311|NCT00401830|Secondary|Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase|Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
148312|NCT00401830|Secondary|Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase|Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
148313|NCT00401830|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase|The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia|Baseline, Last assessment in the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.||Score on a scale||Standard Deviation|Mean
148314|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.||Score on a scale||Standard Deviation|Mean
148315|NCT00401830|Primary|Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)|The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|Baseline, Last 2 weeks of the 12-week Treatment Phase|Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.||Score on a scale||Standard Deviation|Mean
148316|NCT00401778|Secondary|Duration of Hospital Stay Following Surgery.||6 months|||days||Full Range|Median
148317|NCT00401778|Secondary|Safety and Tolerability of RAD001 as Pre-operative Therapy.||6 months||||||
148318|NCT00401778|Primary|Inhibition of Proliferation (Ki67) and Induction of Apoptosis (TUNEL Assay) in Tumor Specimens and Buccal Mucosa.||6 months||||||
148319|NCT00401778|Primary|Effects of RAD001 on the Regulation of Key Proteins Involved With the Mammalian Target of Rapamycin (mTOR) Axis in Tumor Specimens and Buccal Mucosa in Patients With Operable Non-small Cell Lung Cancer (NSCLC).|Changes in the expression of key signaling proteins in the mTOR/phosphatidylinositol 3-kinase (PI3K) pathway were determined by immunohistochemistry using previously published protocols and manufacturers’ recommendations for antigen retrieval and antibody dilution along with positive and negative controls. Two investigators assessed protein expression jointly by light microscopy. The degree of expression was assessed by intensity (0, 1+, 2+, 3+) and percentage of cell staining in line with published algorithm. A derivative score (immunoscore) ranging between 0 and 300 was calculated as the product of intensity and percent cell staining.|6 months|||% change in immunoscore||Standard Deviation|Mean
151883|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|Pre Intervention|||units on a scale||Standard Deviation|Mean
148321|NCT00401752|Secondary|The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.|4 & 8 weeks|||Percentage of participants|||Number
148322|NCT00401752|Secondary|The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.|4 and 8 week|||Percentage of participants|||Number
148323|NCT00401752|Secondary|Percentage of Participants With the Occurance of Any Adverse Event.|Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.|8 weeks|Patients included in safety population||Percentage of participants|||Number
148324|NCT00401752|Secondary|The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8.|week 4 and week 8|||Percentage of participants|||Number
148325|NCT00401752|Secondary|The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.|Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.|8 weeks|||Percentage of participants|||Number
148326|NCT00401752|Primary|The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.|"Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.~(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent)."|4 weeks|||Percentage of participants|||Number
148327|NCT00401726|Secondary|Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse).|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward. Data not available for one participant.||patients|||Number
148328|NCT00401726|Secondary|Change in Sheehan Disability Scale Score From Baseline to 16 Weeks|The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
148329|NCT00401726|Secondary|Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks|IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
148330|NCT00401726|Secondary|Number of Patients Compliant With Therapy|Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of “Never miss” or “Sometimes miss”.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||participants|||Number
148331|NCT00401726|Secondary|Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks|WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
148332|NCT00401726|Secondary|Patient Global Impression of Improvement (PGI-I) Score|PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
148344|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.||Participants|||Number
148333|NCT00401726|Secondary|Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline.|Baseline and 112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||units on scale||Standard Error|Mean
148334|NCT00401726|Primary|Number of Patients Responding “Very Satisfied” on Satisfaction With Depression Care Scale (SDCS)|Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). “Very satisfied” was defined as a score of greater than or equal to 8.|112 days|The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.||participants|||Number
148335|NCT00401622|Primary|To Assess the Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.||From baseline to 52 wks|The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups||Percentage||Standard Error|Least Squares Mean
148336|NCT00401622|Secondary|To Assess the Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.||52 wks|||mg/dL||Standard Deviation|Mean
148337|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.||Units on a scale||Standard Deviation|Mean
148338|NCT00401544|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose|Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.|Baseline and Week 16|Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.||Units on a scale||Standard Deviation|Mean
148339|NCT00401544|Secondary|Time to Hematopoietic Response, by IV Iron Usage|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Weeks||95% Confidence Interval|Median
148340|NCT00401544|Secondary|Time to Hematopoietic Response, by Darbepoetin Alfa Dose|The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Weeks||95% Confidence Interval|Median
148341|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by IV Iron Usage|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Participants|||Number
148342|NCT00401544|Secondary|Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose|Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.||Participants|||Number
148343|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study|Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 5 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5.||Participants|||Number
148410|NCT00400803|Primary|Time to Progression|Time to progression (progression free survival)is defined as the time from the start of treatment until first documented sign of disease progression or death due to any cause. For subjects who do not progress, time to progression will be censored at the time of last tumor assessment.|From Enrollment Through 2 Years|||Months||Standard Error|Mean
148345|NCT00401544|Secondary|Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose|The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.|From Week 1 to Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.||Participants|||Number
148346|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by IV Iron Usage|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.||g/dL||Standard Deviation|Mean
148347|NCT00401544|Secondary|Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose|Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).|Baseline and Week 16|Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.||g/dL||Standard Deviation|Mean
148348|NCT00401544|Secondary|Time to Achieve the Target Hemoglobin Level, by IV Iron Usage|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Weeks||95% Confidence Interval|Median
148349|NCT00401544|Secondary|Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose|The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Weeks||95% Confidence Interval|Median
148350|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Participants|||Number
148351|NCT00401544|Primary|Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose|Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.|From Week 1 to Week 16|Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values < 11.0 g/dL.||Participants|||Number
148352|NCT00401531|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|"Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.~Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population.||Participants|||Number
148353|NCT00401531|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.|Day 150 post-dose 1|Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
148354|NCT00401531|Secondary|Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.|Day 150 post-dose 1|Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population.||Participants|||Number
148355|NCT00401531|Secondary|Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil|Day 150 post-dose 1|Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.||Participants|||Number
148356|NCT00401531|Secondary|Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population.||Participants|||Number
148357|NCT00401531|Primary|Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™|Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.|Day 150 post-dose 1|Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.||Participants|||Number
148358|NCT00401414|Secondary|Proportion of Patients With Serious Adverse Clinical Events.|Defined as an INR>4.0, use of vitamin K, major bleeding events (as defined by the Thrombolysis in Myocardial Infarction [TIMI] criteria), thromboembolic events, stroke (all cause), myocardial infarction, and death (all cause).|90 Days|||participants|||Number
148359|NCT00401414|Secondary|Time to Stable Anticoagulation (in Days).|Defined as two consecutive INRs within the therapeutic range >7 days apart and with no dose change during this time.|90 Days|||Days||Standard Deviation|Mean
148360|NCT00401414|Secondary|Per-patient Percentage of INRs Out of the Therapeutic Range|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days|||percentage of INRs out of range||Standard Deviation|Mean
148361|NCT00401414|Secondary|Time to the First Therapeutic INR.|The INR (international normalized ratio) is a derived measure of the prothrombin time. In this trial, a therapeutic INR was considered 1.8 to 3.2|90 Days|||Days||Standard Deviation|Mean
148362|NCT00401414|Primary|Mean Percentage of Time That INR Within Therapeutic Range Using Linear Interpolation (Rosendaal et al).|"Primary end point: mean percentage of time INR is within therapeutic range. Though target INR was 2.0-3.0, therapeutic INR is considered 1.8-3.2 (allows for INR measurement error and avoids problems inherent in overcorrection).~The international normalized ratio (INR) is one way of presenting prothrombin time test results for people taking the blood-thinning medication warfarin. The INR formula adjusts for variation in laboratory testing methods so that test results can be comparable."|90 Days|||percentage of time||Standard Deviation|Mean
148363|NCT00401401|Secondary|Best Overall Tumor Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|||Participants|||Number
148364|NCT00401401|Secondary|Time to Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|Number of months between date of first infusion and date of best response||months||Full Range|Median
148365|NCT00401401|Secondary|Overall Response|Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|Up to 3 years|||Participants|||Number
148366|NCT00401401|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.|Overall Study|||participants|||Number
148367|NCT00401258|Secondary|Sheehan Disability Scale||At each visit||||||
148368|NCT00401258|Secondary|Irritable Bowel Syndrome-Quality of Life Scale||At each visit||||||
148369|NCT00401258|Secondary|Hamilton Anxiety Rating Scale||At visits 2, 5, 7, and 9||||||
148370|NCT00401258|Secondary|Hamilton Depression Rating Scale||At first visit only||||||
148371|NCT00401258|Secondary|Clinical Global Impression Scale||At each visit||||||
148372|NCT00401258|Secondary|Short Form McGill Pain Questionnaire||At each visit||||||
148373|NCT00401258|Secondary|Brief Pain Inventory||At each visit||||||
148374|NCT00401258|Primary|Abdominal Pain, as Determined by Daily Pain Diaries (Patterned After Item 3 From the Brief Pain Inventory; Cleeland and Ryan, 1994).|Subjects rated abdominal pain daily on a scale of 0-10 (0 being no pain and 10 being worst pain). The pain score at each visit represented the mean score from all days since the previous visit.|baseline and week 12|||Units on a scale||95% Confidence Interval|Mean
148375|NCT00401245|Other Pre-specified|Gender of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Participants|||Number
148376|NCT00401245|Other Pre-specified|Mean Age of the Participants in Tapering Phase|Participants were re-randomized to tapering phase after OL phase.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Years||Standard Deviation|Mean
148377|NCT00401245|Secondary|Change From Baseline in Menopause-specific Quality of Life Questionnaire (MenQOL) Score at Week 4, Week 8, Week 12 and Week 16|MenQOL questionnaire assessed how bothered participants were with 31 symptoms. It contains domains: vasomotor (items 1-3); psychosocial (items 4-10); physical (items 11-26); sexual (items 27-29); in addition to nausea and indigestion. 31 individual symptoms are rated on a scale of 0 (not at all bothered) to 6 (extremely bothered). Total possible score ranged from 0 to 186. MenQOL summary score was calculated as mean of four domain scores (Physical function, Psychosocial function, Sexual function and Vasomotor function) ranging from 1 to 8, with higher scores indicating worse quality of life.|Baseline, Week 4, Week 8, Week 12 and Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Units on a scale||Standard Deviation|Mean
148411|NCT00400764|Primary|Mean Serum Concentration of Dulanermin|The dulanermin serum concentration was measured using enzyme linked immunosorbent assay (ELISA).|Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1.|Safety-evaluable population||µg/ml||Standard Deviation|Mean
148378|NCT00401245|Secondary|Menopause Symptoms-treatment Satisfaction Questionnaire (MS-TSQ) Score|MS-TSQ is a questionnaire assessing participants’ degree of satisfaction with regard to the test article which was administered to the participants via an IVRS/IWRS. The questionnaire comprised 8 questions and each was rated on a scale from 0 (extremely dissatisfied) to 4 (extremely satisfied).|Week 16|The OL population included all participants who had taken at least 1 dose of open label test article. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Units on a scale||Standard Deviation|Mean
148379|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability at the End of Tapering|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an IVRS/IWRS and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Participants|||Number
148380|NCT00401245|Secondary|Number of Participants Showing Satisfaction With Tolerability During the First Two Weeks of Treatment|Satisfaction with tolerability (lack of bothersomeness) was assessed using a questionnaire via an interactive voice response system (IVRS)/interactive web based response system (IWRS), and evaluated based on participants’ response of extremely satisfied, satisfied, neutral, dissatisfied or extremely dissatisfied with the study medication.|Week 1 and Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.||Participants|||Number
148381|NCT00401245|Secondary|Number of Participants With Each DESS One Week After End of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Participants|||Number
148382|NCT00401245|Secondary|Number of Participants With Each DESS at the End of Second Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Participants|||Number
148383|NCT00401245|Secondary|Number of Participants With Each DESS at the End of First Week of Tapering|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article.|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Participants|||Number
148384|NCT00401245|Secondary|Percentage of Participants Discontinuing Treatment Due to AEs in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.||Percentage of participants|||Number
148385|NCT00401245|Secondary|Number of Participants With Other Spontaneously Reported Adverse Events (AEs) in First 2 Weeks of Treatment|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.||Participants|||Number
148386|NCT00401245|Primary|DESS Total Score at 1 Week After the End of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 19|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Units on a scale||Standard Deviation|Mean
148387|NCT00401245|Primary|DESS Total Score at End of Second Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 18|Tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure at the specified time point for each group respectively.||Units on a scale||Standard Deviation|Mean
148388|NCT00401245|Primary|Discontinuation Emergent Signs and Symptoms (DESS) Total Score at the End of First Week of Tapering|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms (1) and 0 for old and unchanged symptom, absent, or old symptom but improved for a total possible range of 0 to 43. A higher score indicates more symptoms."|Week 17|The tapering population included all participants who had completed at least 6 weeks of treatment and taken at least 1 dose of double-blind test article during the tapering phase.||Units on a scale||Standard Deviation|Mean
148389|NCT00401245|Primary|Number of Participants With Nausea During the First 2 Weeks of Treatment|Nausea by spontaneous reports to the investigators was counted if it was reported during first 2 weeks of treatment, and it was not seen before the first dose of treatment, or if it was seen before the first dose and the symptoms got worse. If multiple incidences occurred on the same participant during the 2 weeks, only 1 incidence was counted.|Baseline up to Week 2|The titration population included all randomly assigned participants who had taken at least 1 dose of double-blind test article during the double-blind titration period.||Participants|||Number
148390|NCT00401193|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Baseline over 3 mentrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||percentage of participants|||Number
148391|NCT00401193|Secondary|Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
148392|NCT00401193|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Baseline scores over 3 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
148393|NCT00401193|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 3 menstrual cycles|modified intent to treat population||mL||Standard Deviation|Least Squares Mean
148394|NCT00401102|Secondary|Multidimensional Anxiety Scale for Children||recently||||||
148395|NCT00401102|Secondary|Beck Depression Inventory||2 weeks||||||
148396|NCT00401102|Primary|Self-injury Monitoring Card||1 month||||||
148397|NCT00401102|Primary|Self-Injurious Thoughts and Behaviors Interview||8 weeks|Data for all subjects who completed the study was examined - however because this was a small pilot study and only 5 subjects completed treatment, no statistical tests were completed.||episodes of self-injury past month||Standard Deviation|Mean
148398|NCT00401102|Primary|CDRS||1 week||||||
148399|NCT00401102|Primary|C-GAS||1 month||||||
148400|NCT00401102|Primary|CGI||1 week||||||
148401|NCT00400881|Secondary|Duration of Mechanical Ventilation|Duration in days from day of intubation to day of extubation.|days|Analysis per protocol. All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.||days||Standard Deviation|Mean
148402|NCT00400881|Primary|Duration of Weaning Time|Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.|days|All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.||days||Standard Deviation|Mean
148403|NCT00400829|Secondary|Progression Free Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to the time of documented progression, assessed up to 5 years|||Months||95% Confidence Interval|Median
148404|NCT00400829|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From start of treatment to death from any cause, assessed up to 5 years|||Months||95% Confidence Interval|Median
148405|NCT00400829|Primary|Objective Response Rate (CR or PR) According to RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Tumor measurements repeated every 6 weeks|||percentage of patients responding|||Number
148406|NCT00400803|Secondary|Time to Best Response|Time to best response is defined as the time from the start of treatment until first documented evidence of tumor response (30% decrease or complete disappearance of tumor). For subjects who do not show a tumor response, the time will be censored at the time of last contact.|From Enrollment to First Tumor Response|||Days||Full Range|Median
148407|NCT00400803|Secondary|Overall Survival Time|Overall survival is defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|Baseline to Death|||Months||Standard Error|Mean
148408|NCT00400803|Secondary|Duration of Response|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response(30% decrease or complete disappearance of tumor) until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment.|From Enrollment through Date of First Documented Disease Progression or Date of Death From Any Cause, Whichever Came First, Up to 100 Months|||Days||Full Range|Median
148409|NCT00400803|Secondary|Best Overall Response by Cycle|Number of patients and their best response recorded from the state of treatment until disease progression. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response-disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|After Cycle 4, Cycle 6 and Cycle 7 of Therapy|For subjects who show a response, duration of response is defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment. 5 patients = missing data.||Participants|||Number
148423|NCT00400712|Primary|Subjective Index of Physical Integration (Subscale of SIPSO)|see 'Subjective Index of Physical and Social Outcome (SIPSO) above|baseline and one year|those who completed 1 year testing||points on a scale||Standard Deviation|Mean
148412|NCT00400764|Primary|Number of Participants With a Clinically Significant Laboratory Abnormality|Laboratory Parameters were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). A clinically significant abnormality was defined as a Grade 3 (severe) or Grade 4 (very severe, life threatening, or disabling) laboratory toxicity according to the NCI CTCAE v3.0.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms).|Safety Evaluable population consisting of all randomized patients who received at least one dose of study drug.||participants|||Number
148413|NCT00400764|Primary|Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit|Body temperature was measured at baseline and throughout the study. Change from baseline was calculated using the patients last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||degrees Celsius||Standard Deviation|Mean
148414|NCT00400764|Secondary|Phase II: Duration of Response as Assessed by the Investigator|"An event was defined as documented disease progression or death on study, whichever occurred first. Duration of objective response was defined only for patients with an objective response as determined by the investigator and was the time from the initial response to disease progression or death on study.~Kaplan−Meier methods were used to estimate median, percentiles, and range of duration of response."|From Baseline through Study Termination (up to approximately 33 months)|Safety-evaluable patients with an objective response determined by the Investigator.||months||95% Confidence Interval|Median
148415|NCT00400764|Secondary|Phase II: Objective Response as Assessed by the Investigator|Objective response was defined as a confirmed or unconfirmed complete response(CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. Patients without a post-baseline tumor assessment were considered non-responders.|From Baseline through Study Termination (up to approximately 33 months)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||participants|||Number
148416|NCT00400764|Secondary|Phase II: Overall Survival|Median overall survival could not be estimated because of the low number of deaths at the time of study termination.|From Baseline through Study Termination (up to approximately 33 months)|||months||95% Confidence Interval|Median
148417|NCT00400764|Secondary|Phase II: Progression Free Survival|Progression free survival (PFS) was defined as the time from randomization to documented disease progression or death, whichever occurred first and was based on the investigator's assessment using the modified IWG criteria. Kaplan−Meier methods were used to estimate median time to PFS. Data for patients without disease progression or death on study were censored at the time of the last tumor assessment.|From Baseline through Study Termination (up to approximately 33 months)|Safety-Evaluable population consisting of all randomized patients who received at least one dose of study treatment||months||95% Confidence Interval|Median
148418|NCT00400764|Primary|Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit|Heart rate was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||beats/minute||Standard Deviation|Mean
148419|NCT00400764|Primary|Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit|Blood pressure was measured at baseline and throughout the study. Change from baseline was calculated using the patient's last recorded measurement at the completion of treatment visit - baseline measurement.|Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||mmHg||Standard Deviation|Mean
148420|NCT00400764|Primary|Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)|"Objective response was defined as a confirmed or unconfirmed complete response (CR, CRu) or partial response (PR) assessed on the basis of clinical, radiographic (computed tomography (CT) scans of the neck, chest, abdomen, pelvis and inguinal region), and pathologic (i.e., bone marrow) criteria and according to the modified International Working Group (IWG) criteria. All radiographic and clinical data for the evaluation of objective response were submitted to an IRF for blinded and impartial assessment.~Patients without a post-baseline tumor assessment were considered non-responders."|From Baseline through Study Termination (up to approximately 33 months)|The phase II Efficacy-Evaluable population consisted of all randomized patients who received at least one dose of study treatment and had measurable disease at baseline, as assessed by the IRF.||participants|||Number
148421|NCT00400764|Primary|Number of Participants With Treatment-Emergent Adverse Events by Severity Grade|Safety was assessed through summaries of treatment-emergent adverse events (AEs); AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, according to the following guidelines: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Life-threatening or disabling) and Grade 5 (Death related to AE).|From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II)|Safety Evaluable population, consisting of all randomized patients who received at least one dose of treatment.||participants|||Number
148422|NCT00400764|Primary|Phase Ib: Number of Participants With a Dose-limiting Toxicity|A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).|The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).|The DLT-evaluable population consisted of all patients enrolled in the Phase Ib who received at least two complete cycles of dulanermin and four doses of rituximab and complete study assessments through the DLT Assessment Window without a DLT (usually through Day 28) or experienced a DLT and withdrew from the study within the DLT Assessment Window.||participants|||Number
148425|NCT00400712|Secondary|Health-related Quality of Life - Mental|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.|baseline and one year|those enrolled at 1 year (primary endpoint)||points||Standard Deviation|Mean
148426|NCT00400712|Secondary|Health-related Quality of Life - Physical|The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.|baseline and one year|those enrolled at primary endpoint (one year)||points||Standard Deviation|Mean
148427|NCT00400712|Secondary|Physical Capacity|6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.|baseline and 12 months|all those enrolled at primary endpoint - 1 year||meters||Standard Deviation|Mean
148428|NCT00400712|Secondary|Mobility Function|Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)|baseline and 1 year|those still enrolled at primary endpoint (one year)||seconds||Standard Deviation|Mean
148429|NCT00400712|Primary|Subjective Index of Physical and Social Outcome (SIPSO)|The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration.|baseline and 1 year|those who completed 1 year testing||scores on a scale||Standard Deviation|Mean
148430|NCT00400686|Primary|Number of Patients With an at Least 2gm/dL Increase in Hgb||Baseline to Day 28|||participants|||Number
148431|NCT00400686|Primary|Number of Patients With an at Least 1gm/dL Increase in Hgb||Baseline to Day 28|||participants|||Number
148432|NCT00400686|Primary|Change From Baseline in Hemoglobin at Day 28|Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.|Baseline to Day 28|||g/dL||Full Range|Median
148433|NCT00400634|Other Pre-specified|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 18 Month Visit|Subjects who completed the 12-month double-blind posttreatment period of the study continued to undergo double-blind assessments every 3 months until the last subject had completed the end-of-study visit at month 12. The LOCF method was used to impute data at month 18 for the subjects who had blinded data through month 15.||units on a scale||Standard Error|Least Squares Mean
148434|NCT00400634|Primary|UPDRS Part III OFF|"The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically defined off condition, 12 hours or more after the last administration of medication."|Change from Baseline to 12 Month Visit|Subjects who completed the end-of-study visit at month 12 and had no important protocol deviations that potentially could have affected the efficacy assessment of the study drug.||units on a scale||95% Confidence Interval|Least Squares Mean
148435|NCT00400569|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.|4 years, 7 months|All Participants||participants|||Number
148436|NCT00400569|Secondary|Participants' Overall Survival (OS)|The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.|From On Treatment to Off Study - average of 6 months|All participants who completed the study||months||95% Confidence Interval|Median
148437|NCT00400569|Secondary|Participants' Progression Free Survival (PFS)|Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants who completed the study||months||95% Confidence Interval|Median
148438|NCT00400569|Primary|Number of Participants With Overall Response (OR)|Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).|From On Treatment to Off Study - average of 6 months|All participants assessable for response||participants|||Number
148439|NCT00400400|Secondary|Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores|The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction.|Baseline, Day 30|"Participants from the Intention-to-treat (ITT) population consisting of all randomized participants who received at least one dose of study drug for whom data was available for analysis. n in each of the categories is the number of participants with data available."||Score on a scale||Standard Deviation|Mean
148440|NCT00400400|Secondary|Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment|The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales.|Baseline to Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.||Score on a scale||Standard Deviation|Mean
148441|NCT00400400|Secondary|Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score|This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.||change in score on a scale||Standard Deviation|Mean
148442|NCT00400400|Secondary|Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment|The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia).|30 days|Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
148443|NCT00400400|Secondary|Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score|The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms.|Baseline, Day 30|"Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. n in each of the categories is the number of participants with data."||Score on a scale||Standard Deviation|Mean
148444|NCT00400400|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)|"TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy.~BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria."|30 days|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
148445|NCT00400400|Primary|The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy|Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.|Baseline, Day 30|Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.||Participants|||Number
148446|NCT00400205|Secondary|Measure the Acetylated Tubulin Expression and Correlate With Clinical Outcome.|IHC analysis of AT expression was performed in formalin-fixed, paraffin-embedded tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining.|at baseline||||||
148447|NCT00400205|Primary|Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)|Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].|every 3 months|||participants|||Number
148448|NCT00400179|Primary|Median Survival|Survival was defined as the time from the date of randomization to the time of death (from any cause) for each patient.|The cutoff date for survival analysis was 07 March 2008 (12 months after last patient randomized).|||Months||95% Confidence Interval|Median
148449|NCT00400179|Secondary|Time to Treatment Failure (TTF)|The time from randomization to date of permanent discontinuation of S-1 or 5-FU, first documented PD, or death, whichever occurred first.|From date of randomization until date of permanent discontinuation of S-1 or 5-FU, first documented PD, death, or data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.|||Months||95% Confidence Interval|Median
148450|NCT00400179|Secondary|Progression-free Survival (PFS)|The time from randomization to date of first documented PD or date of death, whichever occurred first.|From date of randomization until date of first documented PD, date of death, or until data cutoff on 07 March 2008 (12 months after last patient randomized), whichever came first.|||Months||95% Confidence Interval|Median
148451|NCT00400179|Secondary|Duration of Response (DR)|Duration of response was defined as the time from date of first confirmed response (CR or PR) to date of first progressive disease (PD) or death. Per the RECIST criteria, definitions were as follows: CR was the disappearance of all target lesions for at least 4 weeks, PR was at least a 30% decrease in the sum of the longest diameter of target lesions, and PD was at least a 20% increase in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient was randomized).|||Months||95% Confidence Interval|Median
148487|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148452|NCT00400179|Secondary|Overall Response Rate (ORR)|The proportion of patients with objective evidence of complete response (CR) or partial response (PR) based on tumor response assessments. Per the Response Evaluation Criteria in Solid tumors (RECIST), CR was defined as the disappearance of all target lesions for at least 4 weeks, and PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions.|Data cutoff was 07 March 2008 (12 months after last patient randomized).|||Percentage of patients in each group||95% Confidence Interval|Number
148453|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−6, ss|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
148454|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0−6,ss|Before drug administration to 6 hours after drug administration on Day 26|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
148455|NCT00400153|Secondary|Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−2,ss.|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
148456|NCT00400153|Secondary|Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours|Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss|Before drug administration to 2 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||μg||Geometric Coefficient of Variation|Geometric Mean
148457|NCT00400153|Secondary|Noncompartmental Parameters of Albuterol at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
148458|NCT00400153|Secondary|Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State|Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).|Before drug administration to 6 hours after drug administration on Day 29|All patients in FAS who were from U.S. study sites and whose blood and/or urine samples were collected at Visit 3 according to the protocol.||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
148459|NCT00400153|Secondary|Rating of Action of Turning Clear Base of Respimat|Frequency of patients due to rating of action of turning clear base of Respimat|12 weeks|Treated set (US patients)||participants|||Number
148460|NCT00400153|Secondary|Device Preference (Respimat or MDI)|Frequency of patients due to device preference|12 weeks|Treated set (US patients)||participants|||Number
148461|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148462|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148463|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148464|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148465|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148466|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148467|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148468|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148565|NCT00399542|Secondary|Month 3 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148469|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148470|NCT00400153|Secondary|Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine|"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied."|12 weeks|Treated set (US patients)||units on a scale||Standard Error|Mean
148471|NCT00400153|Secondary|Frequency Distribution of Satisfaction Rating With Inhaler Attributes||12 weeks|Treated set (US patients)||participants|||Number
148472|NCT00400153|Secondary|COPD Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set||Percentage of patients|||Number
148473|NCT00400153|Secondary|COPD Exacerbation Rate During the On-treatment Period|Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set||Proportion of patients|||Number
148474|NCT00400153|Secondary|Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period|COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.|During the 12-week on-treatment period|Treated Set||Percentage of patients|||Number
148475|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 85|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 85|Treated Set||units on a scale||Standard Error|Least Squares Mean
148476|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 57|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 57|Treated Set||units on a scale||Standard Error|Least Squares Mean
148477|NCT00400153|Secondary|Physician's Global Evaluation Score on Pulmonary Function Testing Day 29|"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent."|Prior to pulmonary function test on Day 29|Treated Set||units on a scale||Standard Error|Least Squares Mean
148478|NCT00400153|Secondary|Trough Peak Expiratory Flow Rate (PEFR)|The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication|Full Analysis Set for Diary Data||liters/min||Standard Error|Least Squares Mean
148479|NCT00400153|Secondary|Daytime Symptom Score|"The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).~Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||units on a scale||Standard Error|Least Squares Mean
148480|NCT00400153|Secondary|Night-time Symptom Score|"The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).~Night−time COPD symptoms: 0=none 1=some − slept well 2=woke once 3=woke several times 4=woke most of night"|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||units on a scale||Standard Error|Least Squares Mean
148481|NCT00400153|Secondary|Daytime Rescue Medication Use|The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||puffs||Standard Error|Least Squares Mean
148482|NCT00400153|Secondary|Night-time Rescue Medication Use|The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)|During the 2-week baseline washout period and the 12-week treatment period|Full Analysis Set for Diary Data||puffs||Standard Error|Least Squares Mean
148483|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 85|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85|During the 6-hour pulmonary function testing after drug administration on Day 85|Treated Set||patients|||Number
148484|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 57|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57|During the 6-hour pulmonary function testing after drug administration on Day 57|Treated Set||patients|||Number
148485|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 29|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29|During the 6-hour pulmonary function testing after drug administration on Day 29|Treated Set||patients|||Number
148486|NCT00400153|Secondary|Rescue Medication Use on Pulmonary Test Day 1|Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1|During the 6-hour pulmonary function testing after drug administration on Day 1|Treated Set||patients|||Number
148566|NCT00399542|Secondary|Month 2 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148488|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148489|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148490|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148491|NCT00400153|Secondary|Peak FVC Response at Day 85|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148492|NCT00400153|Secondary|Peak FVC Response at Day 57|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148493|NCT00400153|Secondary|Peak FVC Response at Day 29|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148494|NCT00400153|Secondary|Peak FVC Response at Day 1|Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148495|NCT00400153|Secondary|FVC AUC4-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148496|NCT00400153|Secondary|FVC AUC4-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148497|NCT00400153|Secondary|FVC AUC4-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148498|NCT00400153|Secondary|FVC AUC4-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148499|NCT00400153|Secondary|FVC AUC0-4 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148500|NCT00400153|Secondary|FVC AUC0-4 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148501|NCT00400153|Secondary|FVC AUC0-4 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148502|NCT00400153|Secondary|FVC AUC0-4 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148503|NCT00400153|Secondary|FVC AUC0-6 at Day 85|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148504|NCT00400153|Secondary|FVC AUC0-6 at Day 57|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148505|NCT00400153|Secondary|FVC AUC0-6 at Day 29|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148506|NCT00400153|Secondary|FVC AUC0-6 at Day 1|Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148507|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 85|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85|Within the 6-hour post-treatment observation period at Day 85|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148508|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 57|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57|Within the 6-hour post-treatment observation period at Day 57|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148509|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 29|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29|Within the 6-hour post-treatment observation period at Day 29|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148510|NCT00400153|Secondary|Time to Peak FEV1 Response at Day 1|The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1|Within the 6-hour post-treatment observation period at Day 1|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148511|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 85|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85|During the 6-hour observation period after drug administration at Day 85|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148512|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 57|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57|During the 6-hour observation period after drug administration at Day 57|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148513|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 29|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29|During the 6-hour observation period after drug administration at Day 29|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148514|NCT00400153|Secondary|Duration of Therapeutic FEV1 Response at Day 1|The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1|During the 6-hour observation period after drug administration at Day 1|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148515|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 85|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85|Within the first 2-hour post-treatment interval at Day 85|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148516|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 57|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57|Within the first 2-hour post-treatment interval at Day 57|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148517|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 29|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29|Within the first 2-hour post-treatment interval at Day 29|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148518|NCT00400153|Secondary|Time to Onset of Therapeutic FEV1 Response at Day 1|Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1|Within the first 2-hour post-treatment interval at Day 1|Full Analysis Set for Pulmonary Function Test Data||Minutes||Inter-Quartile Range|Median
148519|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148520|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148521|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148522|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148523|NCT00400153|Secondary|Peak FEV1 Response at Day 85|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85|Within the first 2-hour post-treatment interval on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148524|NCT00400153|Secondary|Peak FEV1 Response at Day 57|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57|Within the first 2-hour post-treatment interval on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148525|NCT00400153|Secondary|Peak FEV1 Response at Day 29|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29|Within the first 2-hour post-treatment interval on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148526|NCT00400153|Secondary|Peak FEV1 Response at Day 1|Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1|Within the first 2-hour post-treatment interval on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148527|NCT00400153|Secondary|FEV1 AUC4-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57|Between 4 hours and 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148528|NCT00400153|Secondary|FEV1 AUC4-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29|Between 4 hours and 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148529|NCT00400153|Secondary|FEV1 AUC4-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1|Between 4 hours and 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148530|NCT00400153|Secondary|FEV1 AUC0-4 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57|Before drug administration to 4 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148531|NCT00400153|Secondary|FEV1 AUC0-4 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29|Before drug administration to 4 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148532|NCT00400153|Secondary|FEV1 AUC0-4 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1|Before drug administration to 4 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148533|NCT00400153|Secondary|FEV1 AUC0-6 at Day 57|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57|Before drug administration to 6 hours after drug administration on Day 57|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148534|NCT00400153|Secondary|FEV1 AUC0-6 at Day 29|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29|Before drug administration to 6 hours after drug administration on Day 29|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148535|NCT00400153|Secondary|FEV1 AUC0-6 at Day 1|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1|Before drug administration to 6 hours after drug administration on Day 1|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148536|NCT00400153|Primary|FEV1 AUC4-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85|Between 4 hours and 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data 4-6 hours||liters||Standard Error|Least Squares Mean
148537|NCT00400153|Primary|FEV1 AUC0-4 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85|Before drug administration to 4 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148538|NCT00400153|Primary|FEV1 AUC0-6 at Day 85|Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85|Before drug administration to 6 hours after drug administration on Day 85|Full Analysis Set for Pulmonary Function Test Data||liters||Standard Error|Least Squares Mean
148539|NCT00399893|Primary|Number of Participants With Improved Peptide YY (PYY) Regulation From Baseline to 6 Months|Number of participants with improved Peptide YY (PYY) regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis||participants|||Number
148540|NCT00399893|Primary|Number of Participants With Improved Leptin Regulation From Baseline to 6 Months|Number of participants with improved Leptin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|||participants|||Number
148541|NCT00399893|Primary|Number of Participants With Improved Adiponectin Regulation From Baseline to 6 Months|Number of participants with improved Adiponectin regulation from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but data was used for analysis||participants|||Number
148542|NCT00399893|Primary|Number of Participants With Improved Insulin Regulation From Baseline to 6 Months|Number of participants with improved Insulin regulation from baseline to 6 months of Octreotide or Placebo therapy. Insulin regulation was measured by immunochemiluminescent assay.|6 months|Participant withdrew but was used in the data analysis||participants|||Number
148543|NCT00399893|Secondary|Number of Participants With Decreased Body-composition From Baseline to 6 Months by DEXA|Number of participants with decreased body-composition as Measured by Dual Energy X-ray Absorptiometry (DEXA) scan from baseline to 6 months of Octreotide or Placebo therapy|6 months|Data for this outcome was not analyzed||participants|||Number
148544|NCT00399893|Primary|Number of Participants With Decrease in Hunger and Food Intake|Measured by hunger and hyperphagia by questionnaires and parent-reported 72-hour food recall from baseline to 6 months. Multiple questionnaires consisting of a battery of free text answer questions and food diaries are combined in order to make a behavioral assessment of the participants food state of hunger and food intake. There is no defined scale for this assessment. Each participants responses and parent responses are combined.|6 months|For this outcome measure, data from questionnaires and forms was not completed. Data for all questionnaires is not available to report.|||||
148545|NCT00399893|Primary|Number of Participants With Decreased Skin-fold Measurements From Baseline to 6 Months|Number of participants with decreased skin-fold measurements from baseline to 6 months of Octreotide or Placebo therapy|6 months|The skin fold measurements were performed; however, the data was not completed in a manner that could be analyzed; therefore we could not analyze the data. Completed data is not available to complete this outcome.|||||
148546|NCT00399893|Primary|Number of Participants With Decreased BMI Z-score From Baseline to 6 Months|Number of participants with decreased BMI z-score from baseline to 6 months of Octreotide or Placebo therapy|6 months|A participant withdrew but was included in analysis||participants|||Number
148547|NCT00399893|Primary|Number of Participants With Decrease in Weight From Baseline to 6 Months|Number of participants who had a decrease in weight from baseline to 6 months of Octreotide or placebo therapy|6 months|||participants|||Number
148567|NCT00399542|Secondary|Month 3 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148548|NCT00399893|Secondary|Number of Participants With Decreased Body Composition From Baseline to 6 Months by BOD POD®|Number of participants with decreased body-composition as Measured by BOD POD® body composition tracking system from baseline to 6 months of Octreotide or Placebo therapy|6 months|Participant withdrew but data was used for analysis||participants|||Number
148549|NCT00399893|Primary|Number of Participants With Decrease in Fasting Total Ghrelin|Number of participants showing a decrease in Fasting total ghrelin from baseline to 6 months of treatment with Octreotide or placebo|6 months|"Descriptive statistics or percent of change from the baseline for the 5 patients was used.~A patient withdrew but included in analysis."||Participants|||Number
148550|NCT00399763|Secondary|Side Effect Form for Children and Adolescents (SEFCA)|The SEFCA is a clinician-administered instrument that systematically assesses 52 possible side effects and rates them on a scale of 0 (not present) to 3 (severe). The instrument relies on confidential, self-report of the adolescent.The number of serious adverse events was recorded by intervention assignment.|weekly from randomization to 12 weeks post-randomization|||Number of serious adverse events|||Number
148551|NCT00399763|Secondary|Time Line Followback Interview (TLFB)|The TLFB assesses the number of days in which a substance was used in the past 28 days. The TLFB is administered by the clinician and uses a 28-day calendar with anchor points to record this information. This instrument relies on confidential self-report of the adolescent participant. The result is reported as mean change in the number of days used substances in the past 28 days from baseline to the end of treatment using linear mixed models in an intent-to-treat analysis.|12 weeks|||days||95% Confidence Interval|Mean
148552|NCT00399763|Primary|Change in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Attention-deficit/Hyperactivity Disorder (ADHD) Checklist|All 18 ADHD symptoms are rated on a scale of 0 (none) to 3 (severe) since the previous study visit. The scores are summed to create a total ADHD severity scale score ranging from 0 (none) to 54 (most severe). A single value of mean change in ADHD severity for each group (placebo and atomoxetine) was calculated using linear mixed models in an intent-to-treat an analysis.|baseline and weekly through week 12 post randomization|||units on a scale||95% Confidence Interval|Mean
148553|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.|"Number of subjects who reported SAEs during the study.~A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:~Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event"|32 days following first dose of study medication.|||Subjects|||Number
148554|NCT00399568|Primary|Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-4800 mm for 48 hours."|Baseline (just prior to the first dose) through 48 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.||units on a scale (in millimeters)||Standard Deviation|Mean
148555|NCT00399568|Secondary|Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)|Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0)|First dose through 7 day follow up|All analyses of safety were conducted on the Safety population, which included those subjects who received any portion of a dose of study medication.||Subjects|||Number
148556|NCT00399568|Primary|Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.|"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-2400 mm for 24 hours."|Baseline (just prior to the first dose) through 24 hours|All efficacy analyses were conducted using the mITT population, defined as those subjects who received a complete dose of study medication prior to a request for rescue medication.||units on a scale (in millimeters)||Standard Deviation|Mean
148557|NCT00399542|Secondary|Month 3 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF||BMs/week||Standard Deviation|Mean
148558|NCT00399542|Secondary|Month 2 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF||BMs/week||Standard Deviation|Mean
148559|NCT00399542|Secondary|Month 1 Bowel Movement Rates Change From Baseline||28 days|ITT, with LOCF||bowel movements (BMs)/week||Standard Deviation|Mean
148560|NCT00399542|Secondary|Month 3 Quality of Life Change From Baseline|IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|12 weeks|ITT without LOCF||units on a scale||Standard Deviation|Mean
148561|NCT00399542|Secondary|Month 3 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148562|NCT00399542|Secondary|Month 2 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148563|NCT00399542|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148564|NCT00399542|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148577|NCT00399542|Secondary|Month 3 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF||percentage of participants|||Number
148578|NCT00399542|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF||percentage of participants|||Number
148579|NCT00399542|Secondary|Month 1 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|28 days|ITT without LOCF||percentage of participants|||Number
148580|NCT00399542|Secondary|Month 1 Symptom Relief|"3 = Significantly worse, -2 = Moderately worse,~1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved"|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148581|NCT00399542|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148582|NCT00399542|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148583|NCT00399542|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|28 days|ITT with LOCF||units on a scale||Standard Deviation|Mean
148584|NCT00399542|Secondary|Month 1 Spontaneous Bowel Movement Rates Change From Baseline|Any bowel movement not associated with rescue medication use|28 days|ITT with LOCF||spontaneous bowel movements (SBMs)/week||Standard Deviation|Mean
148585|NCT00399542|Primary|Overall Responder Status|"Overall responder: monthly responder for at least 2 out of 3 months~Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|12 weeks|Intention to treat (ITT), without Last Observational Carried Forward (LOCF).||percentage of participants|||Number
148586|NCT00399516|Primary|Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)|"Pain severity as measured by NRS quantifies pain, where 0 is no pain and 10 is worst pain imaginable"|Within 6 months post-implantation|||Percent Change in Pain Rating||Standard Deviation|Mean
148587|NCT00399360|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) of the tibialis anterior was determined using 1H-magnetic resonance spectroscopy (Siemens, Munich, Germany). The change in the intramyocellular lipid measurement between baseline and 12 months is reported.|baseline and 12 months|||mmol/kg||Standard Error|Mean
148588|NCT00399360|Secondary|Cardiorespiratory Fitness|A submaximal exercise stress test was conducted on a cycle ergometer to measure endurance. Subjects cycled between 50-60 revolutions per minute and the workload was progressively increased in increments of 50 watts in stages lasting 3 minutes. Once subjects became fatigued or reached their submaximal heart rate (220-age x 85), the test was stopped and separate readings of heart rate and blood pressure were measured at 1, 3, and 5 min of recovery. Weight-adjusted maximum oxygen consumption (VO2max; ml/kg per minute) was determined. The change in cardiorespiratory fitness between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||ml/kg/min||Standard Error|Mean
148589|NCT00399360|Secondary|Abdominal Visceral Adiposity|Abdominal visceral adipose area was assess by magnetic resonance imaging at the lvel of the L4 pedicle. The change in abdominal visceral adiposity between baseline and 12 months is reported.|baseline and 12 months|||cm2||Standard Error|Mean
148590|NCT00399360|Secondary|C-reactive Protein|High sensitivity C-reactive protein was determined by R&D Systems (Minneapolis, MN) kit. The change in C-reactive protein between baseline and 12 months is reported.|baseline and 12 months|||mg/l||Standard Error|Mean
148591|NCT00399360|Primary|Coronary Artery Calcium Score|Computed tomography (CT) imaging was performed using a SOMATOM Sensation (Siemens Medical Solutions, Forcheim, Germany) 64-slice CT scanner. Agatston calcium score was calculated using CT images. The total Agatston score is calculated by summing up the scores of the individual calcifications in all slices of the CT scan. An absolute Agatston score of less than 10 indicates minimal overall atherosclerosis (plaques) in the coronary arteries. The change in the coronary artery calcium score between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||Agatston score||Standard Error|Mean
148592|NCT00399360|Primary|Systolic Blood Pressure|Systolic blood pressure was measured after 5 minutes rest. The in systolic blood pressure between baseline and 12 months is reported.|baseline and 12 months|||mm Hg||Standard Error|Mean
148593|NCT00399360|Primary|Glucose|Glucose level was determined after an overnight fast. The change in glucose between baseline and 12 months is reported.|baseline and 12 months|||mg/dL||Standard Error|Mean
148594|NCT00399360|Primary|High Density Lipoprotein (HDL)|High density lipoprotein (HDL) was determined after an overnight fast. The change in HDL between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||mg/dL||Standard Error|Mean
148626|NCT00398320|Primary|Toxicity by CTCAE Version 3.0|Participants were monitored every 3 weeks while on study. Toxicity and attributions were as per CTCAE version 3.0 guidelines. Analysis population below is patient who experienced related Grade 3 or higher AE; denominator is 40 total patients enrolled.|Assessed at every visit (approx every 3 wks)|||participants|||Number
148595|NCT00399360|Primary|Waist Circumference|Iliac waist circumference measurements were obtained using an inelastic tape measure. All measurements were obtained in triplicate, with the patient undressed, and then averaged. The change of the waist circumference measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||cm||Standard Error|Mean
148596|NCT00399360|Primary|Carotid Intima Media Thickness|Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.|baseline and 12 months|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.||mm||Standard Error|Mean
148597|NCT00399308|Secondary|Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).|The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.|24 weeks|Intent-to-Treat population||participants|||Number
148598|NCT00399308|Secondary|Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.|The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.|Variable - minimum of 12 weeks of follow-up.|Intent-to-treat population achieving primary outcome||participants|||Number
148599|NCT00399308|Secondary|Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.|Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.|12 Weeks|Intent-to-Treat population||participants|||Number
148600|NCT00399308|Primary|Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator’s Direct Observation.|The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)|12 weeks|Intent-to-Treat population (i.e. all subjects randomized to treatment)||participants|||Number
148601|NCT00399035|Secondary|Time to Wound Healing Complications|Number of days from post-randomisation surgery until wound healing complications|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Days||Full Range|Median
148602|NCT00399035|Secondary|Rate of Resection of Liver Metastases|Number of patients undergoing liver resection, based on patients with liver disease at baseline|Post-randomisation until end of study|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Participants|||Number
148603|NCT00399035|Secondary|Duration of Response|Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.|Treatment period from initial response up until data cut-off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
148604|NCT00399035|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Percentage [change in tumour size (mm) ]||Standard Deviation|Mean
148605|NCT00399035|Secondary|Overall Response Rate|Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Participants|||Number
148606|NCT00399035|Primary|Overall Survival|Number of months from randomisation to the date of death from any cause|Baseline through to date of death upto and including data cut off date of 21/03/10|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
148627|NCT00398320|Primary|12-month Progression Free Survival (PFS)|PFS is defined as the time from enrollment until documented disease progression or death (whichever occurred first).|assessed every 3 months by RECIST|||percentage of participants|||Number
148607|NCT00399035|Primary|Progression-free Survival|RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.|RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
148608|NCT00398983|Primary|Number of Participants With Relapse-Free Response at 1 Year|Relapse free response defined an absence of relapse at one year of follow up.|Baseline to 1 year|||participants|||Number
148609|NCT00398918|Secondary|Score Digit Symbol Modalities Test|Difference score between zonisamide and placebo treatment conditions for the Digit Symbol Modalities Test scores obtained 40 minutes after ingestion of a priming dose of ethanol.This test involves transcribing form a key in which numbers appear below a series of symbols to boxes below symbols matched to those in the key. This task must be completed in 90 nseconds. This test measures visuomotor speed and aspects of attention. Scoring is the total number of correctly transcribed numbers. The maximum score on this test 110 points.|40 minutes post alcohol ingestion|ITT||Numeric Score||Standard Error|Mean
148610|NCT00398918|Primary|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions|Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions|1 day|This was a laboratory based study. An ITT analysis was used.||Grams||Standard Error|Mean
148611|NCT00398632|Secondary|Inventory of Depressive Symptomology||baseline and last visit||||||
148612|NCT00398632|Primary|Global Clinical Impressions Improvement Score re Sexual Functioning|The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction.|baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)|Four subjects completed the study; two withdrew at end of week six. CGI-I ratings for two subjects were done at end of week 6 and this last observation was carried forward in the analysis. CGI-I ratings for the 4 completing subjects were done at end of week 12.||participants|||Number
148613|NCT00398411|Secondary|Overall Survival||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)||participants|||Number
148614|NCT00398411|Secondary|Type of Infection||follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)|intention to treat (ITT)||participants|||Number
148615|NCT00398411|Secondary|Reason for Discontinuation of Treatment|Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||participants|||Number
148616|NCT00398411|Secondary|Time to Occurrence of Fever >= 38°C||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||days||Standard Deviation|Mean
148617|NCT00398411|Secondary|Type of Isolates and Infections||end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||participants|||Number
148618|NCT00398411|Primary|Incidence of Clinically Significant Bacteremia|"Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.~With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant."|end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)|intention to treat (ITT)||participants|||Number
148619|NCT00398398|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of XELOX plus Cetuximab|1 years|||participants|||Number
148620|NCT00398398|Secondary|Overall Survival||1 year|||months||95% Confidence Interval|Median
148621|NCT00398398|Secondary|Progression-free Survival||1 year|||months||95% Confidence Interval|Median
148622|NCT00398398|Primary|Overall Response Rate|Tumor response was evaluated every two cycles by CT scans and other indicated methods, and the patients with complete or partial response required a confirmatory response evaluation at least 4 weeks later. Patients without confirmatory evaluation were not regarded as responders.|6 months|||participants|||Number
148623|NCT00398320|Secondary|Biochemical Markers||Assessed every 3 weeks while on treatment|18 of 40 patients had elevated baseline hormone markers, including Chromogranin A, Gastrin, Glucagon, Pancreatic Polypeptide, VIP, Urine 5HIAA||participants|||Number
148624|NCT00398320|Secondary|Overall Survival|OS is defined as time from enrollment until death from any cause.|Continuous|||months||Full Range|Median
148625|NCT00398320|Secondary|Response Rates|Response rate is defined as percent of patients with complete response (CR) and partial response (PR) as their best response as defined by RECIST criteria (version 1).|Response rates by RECIST criteria assessed every 3 months|||percentage of participants|||Number
148628|NCT00398216|Secondary|Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events|adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose|10 days after first dose|safety analysis dataset||percentage of subjects with bleed events||95% Confidence Interval|Number
148629|NCT00398216|Secondary|Change in Activated Partial Thromboplastin Time (aPTT) From Baseline|change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set||seconds||Standard Deviation|Mean
148630|NCT00398216|Secondary|Change in Prothrombin Time (PT) From Baseline|change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery|end of treatment|perp protocol analysis set||seconds||Standard Deviation|Mean
148631|NCT00398216|Primary|Adjudicated Incidence of VTE|"Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery.~A subject was judged to have a VTE if one or more of the following criteria were met:~Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit~Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit~Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery."|end of treatment|per protocol analysis set||percentage of participants with VTE||95% Confidence Interval|Number
148632|NCT00398138|Primary|Immune Response|Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.|2 years|||participants|||Number
148633|NCT00398138|Primary|Safety|Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).|2 years|||participants|||Number
148634|NCT00398112|Secondary|Duration of Response|Duration of response was calculated from the documentation (date) of first response (CR or PR) until the date of progression or last follow-up in the subset of patients who responded. The median duration of response with 95%CI was estimated using the Kaplan Meier method|Duration on study (up 2 years)|No participants had a confirmed response, there for this analysis cannot be completed.|||||
148635|NCT00398112|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from registration to progression or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)|||months||95% Confidence Interval|Median
148636|NCT00398112|Secondary|Survival Time|Survival time was defined as the time from registration to death due to any cause. The distribution of survival time was estimated using the Kaplan-Meier method.|Duration of study (up to 2 years)|||Months||95% Confidence Interval|Median
148637|NCT00398112|Secondary|Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia|Complete response is described in the primary outcome|Duration of Treatment (up to 12 cycles)|No participants had a confirmed response, there for this analysis cannot be completed.|||||
148638|NCT00398112|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response. >~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy >~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Duration of Treatment (up to 12 cycles)|||participants|||Number
148639|NCT00398086|Secondary|Maximal Degree of Anemia|The maximal degree of anemia (and myelosuppression) was assessed by the overall (any time after first dose of study drug) nadir of hemoglobin levels based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data||g/L||Standard Deviation|Mean
148640|NCT00398086|Secondary|Maximal Degree of Myelosuppression|The maximal degree of myelosuppression was assessed by the overall nadir of absolute neutrophil count (ANC), white blood cell count and platelet count based on clinical laboratory measurements.|During the treatment phase, up to a maximum of 24 months.|Treated patients with available data||x10^9/L||Standard Deviation|Mean
148641|NCT00398086|Secondary|Overall Survival|Overall survival was defined as the time from the date of first dose of study drug to the date of patient death from all causes. Participants who did not die were censored at the last known time the patient was alive. Patient survival was summarized using Kaplan-Meier methods.|Up to approximately 4 years|Treated patients||months||95% Confidence Interval|Median
148642|NCT00398086|Secondary|Duration of Response|Duration of response was assessed by progression-free survival for participants who achieved a confirmed Complete Response or Partial Response, assessed by an Independent Radiological Reviewer.|Up to approximately 4 years|Treated patients with an overall confirmed Complete Response or Partial Response.||months||95% Confidence Interval|Median
148643|NCT00398086|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first, assessed by an Independent Radiological Reviewer. Participants who do not have disease progression or have not died were censored at the last known time that the participant was progression free. Progression-free survival was summarized using Kaplan-Meier methods.~Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients||months||95% Confidence Interval|Median
148680|NCT00397878|Primary|Median Progression Free Survival (PFS)|Proportion of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.|Time from start of treatment to time of progression, up to 4 months|||weeks||Full Range|Median
148644|NCT00398086|Secondary|Percentage of Participants With Disease Control|"Disease control is defined as participants with Stable Disease for at least 16 weeks, or confirmed complete or partial overall response, based on RECIST guidelines and assessed by an Independent Radiological Reviewer.~Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease, and no new non-target lesions or unequivocal progression of existing non-target lesions. Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to approximately 4 years|Treated patients||percentage of participants||95% Confidence Interval|Number
148645|NCT00398086|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response|"Overall Response is defined as the percent of participants who achieve an objective confirmed complete (CR) or partial response (PR). Response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, assessed by an Independent Radiological Reviewer.~CR: The disappearance of all known disease and no new sites or disease-related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers.~PR: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation and no new non-target lesions and/or unequivocal progression of existing non-target lesions. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing."|Up to approximately 4 years|Treated patients||percentage of participants||95% Confidence Interval|Number
148646|NCT00398086|Secondary|Number of Participants With Adverse Events (AE)|"An AE was any untoward medical occurrence, not necessarily having a causal relationship with the patient’s treatment, that began or worsened in grade after the start of study drug through 30 days after the last dose.~A serious AE (SAE) is any untoward medical occurrence that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~Treatment-related AEs (TRAEs) include those assessed by the Investigator as possibly, probably, or definitely related to study treatment.~Severity was graded according to the NCI CTCAE based on the following: Grade 1- Mild; Grade 2 -Moderate; Grade 3 - Severe; Grade 4 - Life-threatening or disabling; Grade 5 - Death related to AE."|Up to 25 months|Treated patients: all enrolled patients who received at least one dose of study drug.||participants|||Number
148647|NCT00398086|Primary|Number of Participants With Dose-limiting Toxicities|"A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3:~Grade 4 neutropenia lasting >3 days in the absence of growth factor support;~Grade 4 neutropenia associated with fever >38.5°C;~Any other Grade 4 hematological toxicity;~Grade 3 thrombocytopenia with hemorrhage;~Grade 3 or 4 nausea, vomiting or diarrhea despite prophylaxis or treatment with an optimal anti-emetic or anti-diarrhea regimen;~Any other Grade 3 or higher non-hematological toxicity attributable to the study drug, excluding alopecia and fatigue."|Cycle 1 (Days 1-28)|Phase 1 treated population||participants|||Number
148648|NCT00398047|Secondary|Expression of p53 and p21||Approximately 12 months|Because no patients completed therapy, no analysis was possible||Participants|||Number
148649|NCT00398047|Secondary|Change in Bone Marrow Apoptosis||Baseline and approximately 12 months|Because no patients completed therapy, no analysis was done||Participants|||Number
148650|NCT00398047|Secondary|Overall Survival||Approximately 12 months|Because no patients completed therapy, and the protocol was closed early, analysis was not performed||Participants|||Number
148651|NCT00398047|Secondary|Time to Progression to Acute Myeloid Leukemia (Blast ≥ 20%) or Death|Death during treatment or disease progression characterized by worsening of cytopenias, increase in the percentage of the blasts, reduction of hemoglobin concentration by at least 2 g/dl or transfusion dependence in the absence of another explanation, such as acute infection, gastrointestinal bleeding, hemolysis.|Approximately 12 months|Because no patients completed therapy, no analysis was possible||Months|||Number
148652|NCT00398047|Secondary|Minor Hematological Improvements|For patients with pretreatment platelet count less than 100,000/mm3, a 50% or more increase in platelet count with a net increase greater than 10,000/mm3 but less than 30,000/mm3|Approximately 112 days|Because no patients completed therapy, no analysis was possible||Participants|||Number
148653|NCT00398047|Primary|Rate of Major Hematological Improvement|For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for red cell transfusion-dependent patients, transfusion independence.|Approximately 112 days|Because no patients completed therapy, no analysis was possible||Participants|||Number
148654|NCT00398047|Primary|Number of Participants With Complete Response|Complete response is normalization of abnormal blood counts, and disappearance of signs of morphological changes in the bone marrow. If the previously present cytogenetic abnormalities are absent then it is referred also as a cytogenetic complete remission.|Approximately 112 days|There were a total of 3 patients accrued on this trial. All were eligible and evaluable for response and evaluable for toxicity, as per protocol.||Participants|||Number
148655|NCT00397930|Primary|Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)|"Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.~PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms."|2-24 months after surgery, chemotherapy, and/or radiation therapy|||units on a scale||Standard Error|Mean
148656|NCT00397904|Primary|Complete and Partial Response Rate||2 years|||participants|||Number
148657|NCT00397891|Secondary|Plasma Amyloid-beta (x-40) Concentrations|Amyloid-beta (A-beta) is a peptide fragment of the amyloid precursor protein which is one of the characteristic hallmarks of Alzheimer's disease (AD). Total plasma amyloid-beta (x-40) was determined using a validated ELISA method.|0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.||picogram per milliliter (pg/mL)||Standard Deviation|Mean
148658|NCT00397891|Secondary|Number of Participants With Positive Serum Anti-Bapineuzumab Antibody|Serum anti-bapineuzumab antibody concentration was determined by using a validated ELISA method.|Baseline (Day 1) up to Week 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||participants|||Number
148659|NCT00397891|Secondary|Serum Bapineuzumab Concentrations|Serum bapineuzumab concentration was determined by using a validated enzyme-linked immunosorbent assay (ELISA) method. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration. Here ‘n’ signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
148660|NCT00397891|Secondary|Serum Decay Half-Life (t1/2) of Bapineuzumab|Serum decay half-life is the time measured for the serum concentration to decrease by one half. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||days||Standard Deviation|Mean
148661|NCT00397891|Secondary|Mean Residence Time of Bapineuzumab|MRT is average time for which the drug molecules resides in the body, after administration. It is calculated as area under the serum concentration versus time first moment curve from time zero (pre-dose) to extrapolated infinite time (AUMC [0 - ∞]) divided by area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (AUC[0 - ∞]). AUMC (0-∞) is calculated as AUMC(0-inf)= AUMCt + [(t x Ct) / kel] + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method, Ct is the concentration at time t and kel is the terminal phase rate constant. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||days||Standard Deviation|Mean
148662|NCT00397891|Secondary|Volume of Distribution at Steady State (Vss) of Bapineuzumab|Volume of distribution is defined as the theoretical blood volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mL||Standard Deviation|Mean
148663|NCT00397891|Secondary|Systemic Clearance (CL) of Bapineuzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mL/hour||Standard Deviation|Mean
148664|NCT00397891|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0 - ∞) is area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mcg*hour/mL||Standard Deviation|Mean
148665|NCT00397891|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab|AUC is a measure of the serum concentration of the drug over time. AUC (0-t) is area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||mcg*hour/mL||Standard Deviation|Mean
148666|NCT00397891|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|PK data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||hours||Full Range|Median
148667|NCT00397891|Secondary|Maximum Observed Serum Concentration (Cmax) of Bapineuzumab|Participants who received bapineuzumab were reported.|0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52|Pharmacokinetic (PK) data set included all randomized participants who had at least 1 available data of serum bapineuzumab, serum anti-bapineuzumab antibody or plasma amyloid beta concentration.||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
151884|NCT00371176|Primary|Clinician Administered PTSD Scale-IV|A 17-item, semi-structured interview of PTSD symptoms. The range of scores is 0-136, with a higher value representing a worse outcome.|Pre Intervention|||units on a scale||Standard Deviation|Mean
148668|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
148669|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||units on a scale||Standard Deviation|Mean
148670|NCT00397891|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6|MMSE measures general cognitive functioning: orientation to time (range: 0 to 5) and orientation to place (range: 0 to 5), registration of 3 words (range: 0 to 3), attention and calculation (range: 0 to 5), recall of 3 words (range: 0 to 3), naming (range: 0 to 2), repetition (range: 0 to 1), comprehension (range: 0 to 3), reading (range: 0 to 1), writing (range: 0 to 1) and drawing (range: 0 to 1). Total score is the sum of sub-scores; total score ranges from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 6|Safety data set included all randomized participants who received at least 1 dose of study medication.||units on a scale||Standard Deviation|Mean
148671|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Neurological Examinations|Neurological examination included the assessment of mental status, cranial nerves, visual fields, sensory, motor, gait, primitive reflexes and tendon reflexes.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
148672|NCT00397891|Primary|Number of Participants With Laboratory Test Results of Potential Clinical Importance|Criteria for PCI laboratory results: hematology (hematocrit [decrease >=5%], hemoglobin [decrease >=20gram/liter {g/L}] from baseline, white blood cells [<3], neutrophils [<1.5], platelet [<100], eosinophils [>0.5] *10^9/L); blood chemistry (sodium [>5], potassium [>0.5], fasting glucose [>0.83], phosphorous [>0.162] millimole/L [mmol/L] above upper limit of normal [ULN] and below lower limit of normal [LLN], non-fasting glucose >5 mmol/L above ULN, >0.56 mmol/L below LLN, creatinine >1.36*ULN, blood urea nitrogen >1.5*ULN, calcium [change of >=0.25 mmol/L], total protein [change of >=20g/L], albumin [change of >=10g/L], uric acid [change of >0.119mmol/L] from baseline and outside normal limits); Liver function tests (alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT] and aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] >2*ULN, total bilirubin >2*ULN, alkaline phosphatase >1.5*ULN, gamma-glutamyl-transpeptidase [GGT] >3*ULN).|Week 1 up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
148673|NCT00397891|Primary|Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance|Criteria for determining PCI ECG result was described as: heart rate (>=120 bpm or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), PR interval (>=220 millisecond (msec) and change of >=20 msec compared to baseline value), QRS interval (>=120 msec), corrected QT (QTc) interval for men (>450 msec), QTc interval for women (>470 msec).|Screening up to Week 16|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
148674|NCT00397891|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Criteria for determining potentially clinically important (PCI) vital signs was described as: supine blood pressure (BP)- systolic (greater than or equal to [>=]160 millimeter mercury [mm Hg] or less than or equal to [<=]90 mm Hg and increase or decrease of >=20 mm Hg compared to baseline value), supine diastolic BP (>=100 mm Hg or <= 50 mm Hg and increase or decrease of >=15 mm Hg compared to baseline value), supine pulse rate (>=120 beats per minute (bpm) or <=45 bpm and increase or decrease of >15 bpm compared to baseline value), body temperature (>38.3 degree Celsius and <35 degree Celsius).|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
148675|NCT00397891|Primary|Number of Participants With Clinically Significant Changes in Physical Examinations|Physical examination included the assessment of abdomen, back/spinal, breasts, external genitalia, extremities, general appearance, head, eyes, ears, nose, throat (HEENT), heart, lungs, lymph nodes and skin.|Screening up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
148676|NCT00397891|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between dose of study medication and up to 52 weeks after the dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to Week 52|Safety data set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
148677|NCT00397878|Secondary|Pre- and Post-treatment Expression Values for Each Biological Correlate|Statistical significance of the associations assessed using a nonparametric Sign Test performed on the difference of the post-treatment and pre-treatment values. A two-sided .05 significance level to be used.|Up to 2 weeks||||||
148678|NCT00397878|Secondary|Time to Progression|Length of time from the start of treatment until disease progression using Kaplan-Meier estimates.|Up to 5 years||||||
148679|NCT00397878|Secondary|Overall Survival|Length of time from start of treatment that participants are still alive using Kaplan-Meier estimates.|Up to 5 years||||||
148681|NCT00397839|Secondary|Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months|Responders are defined as participants who have BMD values >= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.|12 months|Intent-to-treat population||participants|||Number
148682|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.||percent||Standard Error|Least Squares Mean
148683|NCT00397839|Secondary|Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 12.||percent||Standard Error|Least Squares Mean
148684|NCT00397839|Secondary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|6 months|Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.||percent||Standard Error|Least Squares Mean
148685|NCT00397839|Primary|Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12|BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.|12 months|Intent-to-treat population. Includes participants with measurements at Baseline and Month 12.||percent||Standard Error|Least Squares Mean
148686|NCT00397631|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
148687|NCT00397631|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
148688|NCT00397631|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 24 weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
148689|NCT00397540|Secondary|1,3,5-year Overall Survival||1,3,5-year||05/2018||||
148690|NCT00397540|Primary|1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)|The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.|1,3,5 year|ITT analysis||participants|||Number
148691|NCT00397514|Secondary|Cardio-pulmonary Bypass Time||Baseline and after 20 minutes|||min.||Full Range|Median
148692|NCT00397514|Secondary|QRS Duration||Baseline and after 20 minutes of pacing|||ms||Full Range|Median
148693|NCT00397514|Secondary|Ventilatory Support||Unspecified||||||
148694|NCT00397514|Secondary|Inotropic Support||Unspecified||||||
148695|NCT00397514|Secondary|TDI Indices (Tissue Velocities, Tissue Tracking, Regional Strain, and Regional Strain Rates)||Unspecified||||||
148696|NCT00397514|Secondary|Incidence of Low Output Syndrome||Unspecified||||||
148697|NCT00397514|Secondary|Systolic Blood Pressure||Unspecified||||||
148698|NCT00397514|Primary|Cardiac Index||Baseline and after 20 minutes of pacing|||L/min/m2||Full Range|Median
148699|NCT00397488|Primary|Overall Objective Response|Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria|2 years|||participants|||Number
148700|NCT00397462|Secondary|Proximal Tibia Bone Density|Proximal tibia bone mineral density by dual energy x-ray absorptiometry (DXA)|One year|||percent change in bone density||Standard Error|Mean
148701|NCT00397462|Primary|Bone Density of Proximal Femur|Proximal femur bone mineral density by dual energy x-ray absorptiometry (DXA)|One year|||percent change in bone density||Standard Error|Mean
148702|NCT00397254|Secondary|Adverse Experiences|Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Participants|||Number
148703|NCT00397254|Secondary|Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose|Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Percentage of attacks|||Number
148704|NCT00397254|Secondary|Percentage of Attacks With Symptom Elimination at 2 Hours|Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Percentage of attacks|||Number
148705|NCT00397254|Secondary|Headache Severity of All Attacks|4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Units on a scale||Full Range|Median
148706|NCT00397254|Secondary|Average Attack Duration||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Hours||Standard Deviation|Mean
148707|NCT00397254|Secondary|Percentage of Responders|Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group|6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Percentage of Participants|||Number
148708|NCT00397254|Secondary|Number of Migraine Attacks||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Migraine attacks||Standard Deviation|Mean
148709|NCT00397254|Primary|Number of Days With Migraine||6 months|197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).||Days||Standard Deviation|Mean
148710|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
148711|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
148712|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
148713|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148714|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
153038|NCT00360334|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
148715|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148716|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148717|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148718|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148719|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Fold||95% Confidence Interval|Geometric Mean
148720|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Fold||95% Confidence Interval|Geometric Mean
148721|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Fold||95% Confidence Interval|Geometric Mean
148722|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148723|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148724|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Subjects|||Number
148725|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
148726|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titer||95% Confidence Interval|Geometric Mean
148727|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Titers||95% Confidence Interval|Geometric Mean
148728|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.||Subjects|||Number
148729|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Day 180|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Cells||Standard Deviation|Geometric Mean
148730|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], interferon gamma [INF-g] and tumor necrosis factor-alpha [TNF-α].|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Cells||Standard Deviation|Geometric Mean
148731|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (HEM), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents NEU, PLA, RBC, URE and WBC results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
148732|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 24|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available||Cells||Standard Deviation|Geometric Mean
148733|NCT00397215|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.|The geometric mean was calculated for cluster of differentiation (CD) 4/CD 8 T-cells (per million) producing at least one cytokine beside either of the following: CD40 ligand [CD40L], interleukin-2 [IL-2], tumor necrosis factor-alpha [TNF-α] or interferon-gamma [IFN-γ].|At Month 12|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol procedures during the entire study period and for whom assay results for antibodies against at least one study vaccine antigen component were available.||Cells||Standard Deviation|Geometric Mean
148734|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents EOS, HEM, LDE, LYM and MON results.|At Days 0, 2, 21 and 23.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
148735|NCT00397215|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after first vaccination and during the 30-day (Days 0-29) follow-up period after second vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
148736|NCT00397215|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Note: The study period was divided into 4 consecutive periods (Days 0-51, Days 52-180 [Month 6], Months 6-12 and Months 12-24), for which SAEs were collected."|During the entire study period (Day 0 to Month 24).|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
148737|NCT00397215|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one documented dose, for whom data were available.||Subjects|||Number
148738|NCT00397215|Secondary|Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.|Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), creatinine phosphokinase (CRPH), creatinine (CREA), eosinophils (EOS), haemoglobin (HEM), lactate dehydrogenase (LDE), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), urea (URE) and white blood cells (WBC). Per parameter and range, it was assessed whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT, AST, BAS, CREA and CRPH.|At Days 0, 2, 21 and 23|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
148739|NCT00397215|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|"An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.~Note: No AESIs were reported during the entire study period."|During the entire study period (Day 0 to Month 24)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, on a subset of subjects enrolled for this study in Belgium.|||||
148740|NCT00397215|Primary|Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). This outcome only covers results from the adjuvanted groups.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subjects|||Number
148741|NCT00397215|Primary|Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subjects|||Number
148742|NCT00397215|Primary|Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:28. This outcome only covers results from the adjuvanted groups.|At Days 0 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
148743|NCT00397215|Primary|Number of Seroprotected Subjects Against 2 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Subjects|||Number
148744|NCT00397215|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1).|At Days 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Fold||95% Confidence Interval|Geometric Mean
148745|NCT00397215|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1). The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||Titer||95% Confidence Interval|Geometric Mean
148746|NCT00397189|Secondary|The Change From Baseline in Subjective Sleep Maintenance.||3 weeks||||||
148747|NCT00397189|Primary|The Change From Baseline in Subjective Sleep Latency.|Sleep latency (SL) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary. The patients reported subjectively of their SL. The Sleep Diary question 3 (SL) was summarised at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used.|Baseline and 3 weeks|Pre-planned analysis on ITT population age 65-80||minutes||Standard Deviation|Mean
148748|NCT00397150|Primary|Exclusive Breastfeeding Rates in South Africa|The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT||participants|||Number
148749|NCT00397150|Primary|Exclusive Breastfeeding Rates in Uganda|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT||participants|||Number
148750|NCT00397150|Secondary|Per Protocol Analysis of Infant Morbidity||at 3 months of age||||||
148751|NCT00397150|Secondary|Per Protocol Analysis of EBF Rates||at 3 months of age||||||
148752|NCT00397150|Secondary|Growth||(up to 6 months of age)||||||
148753|NCT00397150|Primary|Infant Morbidity, 2 Week Diarrhoea Prevalence||at 3 months of age|||participants|||Number
148754|NCT00397150|Primary|Exclusive Breastfeeding Rates in Burkina Faso|The EBF prevalences (24-h recall) at 12 weeks in the intervention and control clusters.|at 3 months of age|ITT||participants|||Number
148755|NCT00397033|Other Pre-specified|Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject’s report of his or her condition and clinician’s behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline YMRS total score of >= 16.||points on scale||Standard Deviation|Mean
148756|NCT00397033|Other Pre-specified|Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16|11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject’s report of his or her condition and clinician’s behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.|Baseline|Intent-to-Treat population with a baseline YMRS total score of >= 16.||points on a scale||Standard Deviation|Mean
148757|NCT00397033|Secondary|Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder|The CGI-C rating scale is a 7 point global assessment that measures the clinician’s impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to “No change”. Ratings of <4 are equivalent to “improvement” and ratings of > 4 are equivalent to “worsening”.|Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.||points on a scale||Standard Deviation|Mean
148758|NCT00397033|Primary|The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point|Intent-to-Treat population||points on scale||Standard Deviation|Mean
148759|NCT00397033|Secondary|Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder|The CGI-S rating scale is a 7 point global assessment that measures the clinician’s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to “Normal, not at all ill” and a rating of 7 is equivalent to “Among the most extremely ill subjects”.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.||points on scale||Standard Deviation|Mean
148760|NCT00397033|Secondary|Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline|The CGI-S rating scale is a 7 point global assessment that measures the clinician’s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to “Normal, not at all ill” and a rating of 7 is equivalent to “Among the most extremely ill subjects”.|Baseline|Intent-to-Treat population.||points on a scale||Standard Deviation|Mean
148761|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score|Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
148762|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score|Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
148763|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score|Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
148764|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score|Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
148765|NCT00397033|Other Pre-specified|Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.||points on scale||Standard Deviation|Mean
148766|NCT00397033|Other Pre-specified|Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16|Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.|Baseline|Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16.||points on a scale||Standard Deviation|Mean
148767|NCT00397033|Secondary|Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score|Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.||points on a subscale||Standard Deviation|Mean
148768|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
148769|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population||points on a subscale||Standard Deviation|Mean
148770|NCT00397033|Secondary|Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population.||points on subscale||Standard Deviation|Mean
148771|NCT00397033|Secondary|Number of Participants With Response|Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of <= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject.|Baseline to Week 6 LOCF End Point|Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.||count of participants|||Number
148772|NCT00397033|Primary|Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.||points on a scale||Standard Deviation|Mean
148773|NCT00396981|Secondary|Target Aneurysm Recurrence||5 years|||participants|||Number
148774|NCT00396981|Secondary|Target Aneurysm Recurrence||3 years|||participants|||Number
148775|NCT00396981|Secondary|Target Aneurysm Recurrence||2 years|||participants|||Number
148776|NCT00396981|Secondary|Technical Procedure Success||Post-procedure|||percentage of participants|||Number
148777|NCT00396981|Secondary|Neurological Assessments|"The changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects same or better."|12 months|||percentage of participants|||Number
148778|NCT00396981|Secondary|Angiographic Assessments|"Number of participants with angiographic assessment of complete obliteration."|Reintervention or 12 months|||participants|||Number
148980|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum Plasma Drug Concentration (Cmax), given sampling scheme|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/ml||Full Range|Median
148779|NCT00396981|Primary|Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.||12 months|A totoal of 630 subjects were planned for the study. All enrolled MAPS trial subjects' data is included in the ITT anaylsis except for four subjects who were excluded due to the following reasons: one subject did not have an aneurysm and three subjects', a the request of the IRB, due to non GCP compliance in obtaining the inofrmed consent.||participants|||Number
148780|NCT00396877|Secondary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology. Participants who had multiple bleedings could be counted several times.|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the same population as previously (i.e. exposed population).||participants|||Number
148781|NCT00396877|Secondary|Number of Participants With Bleeding Events|"Bleeding events spanning from signature of the Informed Consent Form up to the last visit were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from randomization up until 28 days after treatment discontinuation or final follow-up visit, whichever came first, and participants who experienced bleeding events during that period were counted."|From randomization up to 28 days after treatment discontinuation or final follow-up visit, whichever comes first|The analysis was performed on the exposed population (i.e. all randomized participants who received at least one dose of study drug regardless of the amount of treatment received). Participants were included in the treatment group according to the treatment received.||participants|||Number
148782|NCT00396877|Primary|Number of Participants Reaching Primary Endpoint Criteria (First Occurrence of Death / Shunt Thrombosis / Cardiac Procedure < 120 Days Considered of Thrombotic Nature)|"The primary endpoint was the first occurence of any of the following events: Death (including heart transplant); Shunt thrombosis requiring intervention; Hospitalization for bi-directional Glenn procedure or any cardiac related intervention prior to 120 days of age following an event or a shunt narrowing considered to be of thrombotic nature by the blinded adjudication committee.~Only the first event was counted."|Median follow-up of 5.8 months (up to a maximum of 12 months after randomization)|The analysis was performed on the intent-to-treat (ITT) population (i.e. all randomized participants irrespective of whether or not the participant actually received study drug or the participant's compliance with the study protocol). Participants were included in the treatment group to which they were originally allocated.||participants|||Number
148783|NCT00396812|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 48|ESR is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm/hr||Standard Deviation|Mean
148784|NCT00396812|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 48|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker or wheelchair, or help is received from another person in the daily living activities. If an aid or device is used or help is received then a category score of 0 or 1 increases to a category score of 2. A category score of 3 remains a 3 regardless of aids, devices, or help. Scores from each of the 8 categories are totaled. The total score can range from 0 to 24. Change from baseline is computed as the total score at Week 48 minus the baseline total score. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
148785|NCT00396812|Primary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
148786|NCT00396812|Primary|Change From Baseline in Physician’s Global Assessment of Patient’s Disease Activity- Visual Analog Scale (PhGADA-VAS) at Week 48|Change from Baseline in PhGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm||Standard Deviation|Mean
148787|NCT00396812|Primary|Change From Baseline in Patient’s Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS) at Week 48|Change from Baseline in PtGADA-VAS (0 to 100 millimeters visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm||Standard Deviation|Mean
148788|NCT00396812|Primary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 48|Change from Baseline in PAAP-VAS (0 to 100 millimeters visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 48 minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||mm||Standard Deviation|Mean
148996|NCT00396032|Secondary|Change in BFR From Baseline to the End of HD at Visit 1|BFR is measured in mL/minute.|Visit 1 of HD treatment|MITT population||percentage of participants|||Number
148789|NCT00396812|Primary|Change From Baseline in Swollen Joint Count at Week 48|Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
148790|NCT00396812|Primary|Change From Baseline in Tender Joint Count Score at Week 48|Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 48 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Units on a scale||Standard Deviation|Mean
148791|NCT00396812|Primary|Change From Baseline in the Disease Activity Score- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28-ESR is a score on a scale (0 to 10) that is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR (mm/hour). Lower score indicates less disease activity. Flares in disease activity are defined as an increase in this score of greater than 1.2 and remission is defined as achieving a DAS28-ESR score of less than 2.6.|Baseline (Day 0), Week 48|All subjects who receive at least one dose of study treatment and attended Day 0 and Week 48 visits||Score on a scale||Standard Deviation|Mean
148792|NCT00396656|Secondary|Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. Pulse wave velocity is the speed of the forward traveling wave and can be used as a measure of arterial stiffness since the more rigid the wall of the artery, the faster the wave moves.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Meters per second||Standard Deviation|Mean
148793|NCT00396656|Secondary|Arterial Pressure Waveform Augmentation Index at the End of Treatment|Using applanation tonometry, the arterial pulse form measured at the wrist was analyzed using computerized pulse wave analysis. The arterial pressure waveform has two components; the first is the forward traveling wave when the left ventricle contracts and the second is the reflected wave returning from the periphery. The augmentation index is the ratio of the first and second systolic peaks and is used as a surrogate measure of arterial stiffness.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Ratio||Standard Deviation|Mean
148794|NCT00396656|Secondary|Mean Post-treatment Microcirculation at NaCl Injected Sites|10 µl of NaCl was injected intra-dermally at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
148795|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites|10 µl of sodium nitroprusside at a concentration of 10-7 M was injected intra-dermally at 1 site on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. A mean for the 2 NaCl sites was calculated and compared to the sodium nitroprusside mean. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
148796|NCT00396656|Secondary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) plus 10 µl L-NMMA (10-6 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
148797|NCT00396656|Primary|Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites|10 µl of acetylcholine (ACH) at 3 concentrations (10-7, 10-8, 10-9 M) was injected intra-dermally at 3 sites on the forearms. NaCl was injected at 2 sites on the forearms. Microcirculation was measured using laser doppler velocimetry before and 12 times in the 30 minutes following injection. The mean difference of the 12 post-injection measurements to the pre-injection measurement was calculated. Means for the 3 ACH and the 2 NaCl sites were calculated and compared. Microcirculation was measured in perfusion units which is an arbitrary measure specific to each laser doppler scanner.|At end of each treatment period (Week 21 and Week 43)|Intent-to-treat (ITT) population: All randomized patients with at least one valid post-baseline primary efficacy measurement in both treatment periods.||Perfusion units||Standard Deviation|Mean
148838|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
148798|NCT00396630|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Up to Visit 4.|The analyses were performed on the Total Vaccinated Cohort||subjects|||Number
148799|NCT00396630|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days after any doses.|The analyses were performed on the Total Vaccinated Cohort||subjects|||Number
148800|NCT00396630|Secondary|Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.|"GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting.~RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA)."|Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.|The analyses were performed on the Total Vaccinated Cohort||subjects|||Number
148801|NCT00396630|Secondary|Anti-rotavirus IgA Antibody Concentration.|Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.||U/mL||95% Confidence Interval|Geometric Mean
148802|NCT00396630|Secondary|Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.|Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.|At Visit 3 (Week 13).|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
148803|NCT00396630|Secondary|Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.||During the entire study period.||||||
148804|NCT00396630|Secondary|Analysis by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.||During the entire study period.||||||
148805|NCT00396630|Secondary|Duration of Human Rotavirus (HRV) Shedding Per Study Group.|Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.|From Day 0 up to Week 13|The analysis was performed on the According To Protocol analysis for immunogenicity, on the twins whose placebo recipient had at least one stool sample positive for the rotavirus strain.||Number of days||Inter-Quartile Range|Median
148806|NCT00396630|Primary|Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.|Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.|On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity.||subjects|||Number
148807|NCT00396591|Secondary|Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60 days after last dose of treatment (approximately 2 years), or until TEAE was resolved or stabilized|All participants who received at least part of 1 dose of the study treatment.||participants|||Number
148808|NCT00396591|Secondary|Number of Participants With a Positive Anti-drug Antibody Response|"Anti-drug antibodies in participant's serum were measured using 2 different methods~an Enzyme Linked Immunosorbent Assay (ELISA) in which the lower limit of detection (LLOD) was 238.4 ng/mL; and~an Electrochemiluminescence-based, Bridging Assay in which the validated LLOD was about 5.4 ng/mL in the absence of aflibercept and about 25.2 ng/mL in the presence of 20 μg/mL of aflibercept.~Participants with detectable anti-drug antibodies by either method were considered to have a positive anti-drug antibody response."|up to 60 days after the last dose of treatment|Participants who received at least part of 1 dose of aflibercept and had evaluable blood samples||participants|||Number
148809|NCT00396591|Secondary|Overall Survival (OS) Time|OS time was the time interval between the date of registration to the date of death from any cause. Median OS was estimated from Kaplan-Meier curves. Participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.|up to 6 months post-registration|All participants were analyzed. 5 participants who died after efficacy data cutoff date (6 months postregistration) were censored at the data cutoff date.||days|Participants|95% Confidence Interval|Median
148810|NCT00396591|Secondary|Progression-free Survival (PFS) Time|"According to the Response Evaluation Criteria in Solid Tumors [RECIST], progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.~PFS time was interval from the date of registration to the date of tumor progression or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~If participants were alive and progression-free at 6 months postregistration, they were censored for PFS."|up to 6 months post-registration|Participants with a PFS event (tumor progression or death) were analyzed.||days||95% Confidence Interval|Median
148811|NCT00396591|Secondary|60-day Frequency of Paracentesis (FOP)|FOP was the total number of paracenteses performed within the first 60 days postregistration. For participants who had withdrawn after registration but prior to the 60-day cutoff date, the withdrawal would have been regarded as a paracentesis event and the 60-day FOP normalized and calculated as the nearest integer of the value corresponding to 60 × number of paracenteses / x, where x represents the number of days on study.|up to 60 days post-registration|||paracenteses||Standard Deviation|Mean
148822|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after third dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
148812|NCT00396591|Secondary|Time to Repeat Paracentesis (TRP)|TRP is the number of days between the date of registration and the date of the first postregistration paracentesis. Median TRP was estimated from Kaplan-Meier curves. For participants who did not undergo a postregistration paracentesis while on study, TRP was censored at the end of the treatment period (last dose + 1 cycle), at the last visit known without repeat paracentesis, at 6 months postregistration, or at death, whichever was earlier.|up to 6 months from registration|All participants were analyzed. 8 had one or more paracentesis events. Participants with no paracentesis events were censored at the end of the treatment period (last dose + 1 cycle).||days|Participants|95% Confidence Interval|Median
148813|NCT00396591|Primary|Percentage of Participants With a Repeat Paracentesis Response (RPR)|"RPR was defined as at least a two-fold increase in the time to repeat paracentesis (TRP) as compared to the average duration of the 2 intervals between the 3 most recent paracenteses prior to study registration (ie, the baseline interval of paracentesis).~Percentage of participants with a repeat paracentesis response were the number of participants with RPR / number of total participants * 100."|up to 2 years post-registration|||percentage of participants||95% Confidence Interval|Number
148814|NCT00396565|Secondary|Change From Baseline in Clinical Global Impression Scale (CGI-S)|The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 – Not ill, 2 – Very Mild, 3 – Mild, 4 – Moderate, 5 – Marked, 6 – Severe, and 7 – Extremely Severe.|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Error|Mean
148815|NCT00396565|Secondary|Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])|Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||Percentage of participants|||Number
148816|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
148817|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
148818|NCT00396565|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine(OLZ) group was set as an active drug group to examine clinical position of paliperidone(PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
148819|NCT00396565|Primary|Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and 6 weeks|Full Analysis Set excludes subjects who didn’t receive test drug or didn't have post-treatment efficacy data. The Olanzapine (OLZ) group was set as an active drug group to examine clinical position of paliperidone (PAL) ER, and the superiority or non-inferiority of PAL ER 6mg to OLZ 10mg wasn't verified. LOCF imputation method was applied.||scores on a scale||Standard Deviation|Mean
148820|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period||Percentage of patients||95% Confidence Interval|Number
148821|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
148997|NCT00396032|Primary|Incidence of Targeted Adverse Events (AEs) From Initial Study Drug Administration Through the Start of Visit 2|Targeted AEs were intracranial hemorrhages (ICHs), major bleeding, embolic events, thrombosis, catheter-related bloodstream infections (CRBSIs), and catheter related complications|Visits 1 and 2 of consecutive HD treatments|MITT population||percentage of participants|||Number
148823|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after third dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
148824|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after third dose|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
148825|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
148826|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population||Percentage of patients||95% Confidence Interval|Number
148827|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
148828|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population||Percentage of patients|||Number
148829|NCT00395876|Secondary|Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148830|NCT00395876|Primary|Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug|Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148831|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 3|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[percent]|Participants|Standard Deviation|Mean
148832|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 2|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[percent]|Participants|Standard Deviation|Mean
148833|NCT00395863|Secondary|Percentage of Contrast Enhancement of the Lesion - Reader 1|Quantitative parameter derived from signal intensity (SI) measurements. LCE ([SI of lesion (postdose)-SI of lesion (predose)]/Standard SI of lesion (predose)]|Postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[percent]|Participants|Standard Deviation|Mean
148834|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
148835|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
148836|NCT00395863|Secondary|Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1|Change from predose to postdose in contrast-to-noise ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
148837|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
148839|NCT00395863|Secondary|Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1|Change from predose to postdose in lesion-to-brain ratio computed. Comparison of the differences in change were analyzed.|Predose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants. Lesion-level analysis.||[ratio]|Participants|Standard Deviation|Mean
148840|NCT00395863|Secondary|Lesion Contrast Enhancement Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.||Contrast-enhanced Images|Participants||Number
148841|NCT00395863|Secondary|Lesion Border Delineation|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.||Contrast-enhanced Images|Participants||Number
148842|NCT00395863|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferreed, both contrast agents were equal, or the image with Magnevist was preferred.|Postdose Images for MultiHance Exam and for Magnevist Exam Compared|Include all ITT population. The number of units analyzed is the total number of technically adequate postdose images assessed by the reader from the total number of participants with both MultiHance- and Magnevist-enhanced images. Patient-level analysis.||Contrast-enhanced Images|Participants||Number
148843|NCT00395850|Secondary|Retention||14 weeks|those who were entered the disulfiram phase,e tc.||Weeks||Standard Deviation|Mean
148844|NCT00395850|Primary|Cocaine Use Over Time|Urine toxicology results (dichotomous: positive or negative) for the presence of cocaine/cocaine metabolite during the disulfiram phase of the study. The change in the probability of a cocaine positive urine sample per day was assessed for each dose compared with placebo and slopes for each dose condition were calculated from Repeated Measures Genearlized Linear Models on a Binomial distribution (thus a Repeated Measures Logistic Regression)|thrice weekly for 12 weeks|number is based on those who participated long enough to have assessments completed at two time points during the disulfiram phase||slope (change in prob of coc-pos utox/d)|||Number
148845|NCT00395746|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.||number of events per year of exposure|||Number
148846|NCT00395746|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
148847|NCT00395746|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
148848|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
148849|NCT00395746|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
148850|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
148851|NCT00395746|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
148852|NCT00395746|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
148853|NCT00395746|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
148854|NCT00395746|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
148855|NCT00395746|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
148856|NCT00395746|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
148857|NCT00395746|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
148858|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 3|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Vessels|||Number
148859|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 2|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Vessels|||Number
148860|NCT00395733|Secondary|MRA Diagnosis by Blinded Reader 1|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Vessels|||Number
148861|NCT00395733|Secondary|MRA Diagnosis by Investigators|The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.||Vessels|||Number
148862|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3|Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Participants|||Number
148863|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2|Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Participants|||Number
148864|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1|Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||Participants|||Number
148865|NCT00395733|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator|The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.|immediately before and 20-30 seconds after injection (precontrast and postcontrast)|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.||Participants|||Number
148866|NCT00395733|Primary|Number of Vessel Segments Visualized With Diagnostic Quality|Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.|20-30 seconds after injection|Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.||vessel segments||Standard Deviation|Mean
148867|NCT00395694|Secondary|Percentage of Participants With Monocyte Values Outside the Normal Range (Shifted High) at Weeks 4 and 8|Monocytes are a type of white blood cell (WBC; typically comprising 2%-8% of total WBCs) and are a part of the immune system. The normal range for adults is 0.2 to 0.95 * 10^3 cells per microliter (µL); the normal range for adolescents is 0 to 0.8 * 10^3 cells per µL. The monocyte count may increase during chronic inflammation, stress response, immune-mediated disease, viral fever, etc. The percentage of participants (par.) with monocyte values outside the normal range was calculated as 100 * (number of par. with monocyte values outside the normal range) divided by the total number of par.|Week 4 and Week 8|Safety Population||percentage of participants|||Number
148868|NCT00395694|Secondary|Number of Rash Events (Including SJS and Any Other Serious Drug Eruption) Adjudicated by the Rash Adjudication Committee in Participants Taking VPA|The rash adjudication committee reviewed all rash events from a dermatologic standpoint based on the nature, onset site, affected area, time to onset, outcome, and the investigator's comments to adjudicate whether or not the reported event was a drug eruption. A drug eruption is an eruption or a solitary lesion caused by a drug taken internally, often a result of allergic sensitization.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||adjudicated rash events|Participants||Number
148869|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
148870|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||participants|||Number
148871|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
148872|NCT00395694|Secondary|Number of Participants With Any Rash Event (Including SJS and Any Other Serious Drug Eruption) up to the End of the Maintenance Phase|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|Up to Week 8 of the Maintenance Phase (Study Week 14)|Safety Population||participants|||Number
148873|NCT00395694|Secondary|Percent Change in Seizure Frequency of the Indicated Types of Seizures|Percent change in seizure frequency was calculated as 100 * (pre-treatment seizures minus MP seizures)/pre-treatment seizures. Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types, mental retardation or regression, and abnormal findings on an ECG.|Pre-treatment (Day 0) and Week 8 of the Maintenance Phase (Study Week 14)|FAS Population||percent change||95% Confidence Interval|Median
148884|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains (symptoms, emotions, exposure to environmental stimuli and activity limitation). Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The overall AQLQ score is the mean response to all 32 questions (low=1, high=7). Higher values represent better quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
148874|NCT00395694|Secondary|Percentage of Participants With at Least a 50 Percent Reduction in Seizure Frequency for the Indicated Types of Seizures|Partial seizures are seizures that affect only a part of the brain at onset. Tonic-clonic seizures (grand mal seizures) affect the entire brain and are characterized by a generalized involuntary muscular contraction and cessation of respiration followed by tonic and clonic spasms of the muscles. Lennox-Gastaut syndrome (LGS) is a pediatric epilepsy syndrome characterized by multiple seizure types; mental retardation or regression; and abnormal findings on an electroencephalogram (EEG), with paroxysms of fast activity and generalized slow spike-and-wave discharges.|8 weeks|Full Analysis Set (FAS) Population: all enrolled participants except those who had no assessments of the main efficacy variable (percent reduction in seizure frequency).||percentage of participants|||Number
148875|NCT00395694|Secondary|Number of Drug-related and Not Related Rash Events (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"The adverse event of rash was considered to be drug-related when the Investigator answered Yes to the following question: Is there a reasonable possibility that the adverse event may have been caused by the investigational product?."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
148876|NCT00395694|Secondary|Number of Participants With the Indicated Intensity of Rash (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|The rash events (including SJS and any other serious drug eruption) were classified into severe (rash prevents participant from leading a normal life), moderate (participant's discomfort due to rash interferes with daily life), and mild (no interference with participant's daily life due to rash), based on the intesity of the event.|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.||participants|||Number
148877|NCT00395694|Secondary|Number of Rash Events Experienced (Including SJS and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population. Only those participants who had experienced any rash event were evaluated.||rash events|||Number
148878|NCT00395694|Primary|Number of Participants With Any Rash Event (Including Stevens–Johnson Syndrome [SJS] and Any Other Serious Drug Eruption) During the Initial 8 Weeks of Study Treatment|"Any rash event (including SJS or any other serious drug eruption) includes: all event terms containing rash; drug eruption; SJS; toxic epidermal necrolysis; rash generalized; and events grouped into the Skin and Subcutaneous Tissue Disorders system organ class per the Medical Dictionary for Regulatory Activities (MedDRA), including the above-mentioned events that the GSK medical advisors judged to be included as any rash event. SJS, also called as erythema multiforme, is a skin disorder resulting from an allergic reaction or infection."|8 weeks|Safety Population: all participants enrolled in the study who received at least one dose of study medication||participants|||Number
148879|NCT00396409|Secondary|Lung Function as Assessed by Peak Expiratory Flow (PEF)|The spirometric parameter Peak Expiratory Flow (PEF) was measured during grass pollen season before each injection of Depigoid. PEF was collected in the patient diary at seven days after visit 22, 23 and 24 as well as 35, 36 and 37. For analyzing purposes these data were averaged after the respective visits. Missing PEF-values from the patient diary were not replaced.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)||liters per minute (L/min)||Standard Deviation|Mean
148880|NCT00396409|Secondary|Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1)|The spirometric parameter Forced Expiratory Volume in One Second (FEV1) was measured during grass pollen season before each injection of Depigoid.|Assist during 2007 and 2008 pollen season|Intent-to-Treat (ITT)||milliliters (mL)||Standard Deviation|Mean
148881|NCT00396409|Secondary|Work Productivity and Activity Impairment|The Work Productivity and Activity Impairment questionnaire measures time missed from work, impairment of work and regular activities. It consists of 6 items. The outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The minimum value is 0 (0 %), the maximum value is 1 (100%). The recall time is 1 week. For this study WPAI-AA was used defining the specific health problem as allergic asthma, which has been validated by the instrument owner.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
148882|NCT00396409|Secondary|Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline|Both the AQLQ and RQLQ clinical differences were categorized as important, moderate, or meaningful improvement; no clinical change; meaningful, moderate, or important impairment. Clinically important differences in scores between any two assessments have been determined by the authors of the AQLQ and RQLQ. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline of core study and 52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||participants|||Number
148883|NCT00396409|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinoconjunctivitis. It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions). Patients recall their experiences during the previous week and to score each item on a 7-point scale. The overall RQLQ score is the mean response to all 28 questions (low=1, high=7). Higher values represent worse quality of life.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
148885|NCT00396409|Secondary|Asthma Control Questionnaire (ACQ)|The Asthma Control Questionnaire (ACQ) was developed and validated for assessing asthma symptom control in patients in clinical trials as well as for individuals in clinical practice. It is a simple questionnaire consisting of seven questions assessing symptoms, airway caliber and rescue β2-agonist use. It uses a 7-point scale. The possible minimum value is 1, the possible maximum value is 7. Higher values represent worse asthma control and quality of life, respectively.|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
148886|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient|The patient's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1=’excellent’, 2=’good’, 3=’moderate’, 4=’poor’, 5=’worsening’ and (.)=’missing’).|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||percentage of participants|||Number
148887|NCT00396409|Secondary|Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator|The investigator's assessment of the global evaluation of treatment effectiveness (GETE) using a five point scale, which evaluates change in asthma control/symptoms. GETE is scored as 1=’excellent’, 2=’good’, 3=’moderate’, 4=’poor’, 5=’worsening’ and (.)=’missing’).|52 Weeks (2007) and 104 Weeks (2008) after completion of core study|Intent-to-Treat (ITT)||percentage of participants|||Number
148888|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Rescue Medication Score|Asthma/Rhinoconjunctivitis rescue medication score is a component of symptom load. Patients were advised that between visits they could take short acting β-2 agonist rescue medication as initial rescue medication for symptoms of intercurrent bronchospasm. Patients were advised that between visits they could take rescue medication (systemic antihistamines) on an as-needed basis for symptoms of grass pollen allergic rhinoconjunctivitis. The symptom load and all its components were based on the patient’s entries in their diaries.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
148889|NCT00396409|Secondary|Asthma/Rhinoconjunctivitis Symptom Severity Score|The symptom severity score was defined as the mean of the daily symptom severity scores (asthma symptoms during the day, asthma symptoms at night, rhinitis symptoms, and conjunctivitis symptoms) during the pollen season. The daily symptom severity scores were evaluated daily by the patient using a 4-point scale (0 = none (no symptom), 1 = mild, 2 = moderate, 3 = severe) and were recorded in a patient diary. The possible minimum value for the Asthma/Rhinoconjunctivitis Symptom Severity Score is 0, and the possible maximum value is 3. Higher values represent a worse outcome.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT)||units on a scale||Standard Deviation|Mean
148890|NCT00396409|Primary|Daily Symptom Load|The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the patient using a 4-point scale (0=no symptom, 1=mild, 2=moderate, 3=severe). Point values were assigned by specific rescue medication usage. The daily scores were averaged over pollen days by site.|Recorded daily during the 2007 and 2008 pollen season|Intent-to-Treat (ITT). The complete analysis population who consisted of all patients that received at least one dose of study drug was used for all efficacy and safety evaluations in this extension period.||units on a scale||Standard Deviation|Mean
148891|NCT00396383|Post-Hoc|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg|Number of participants achieving ≥ 2*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Total was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor||participants|||Number
148892|NCT00396383|Secondary|Number of Participants With a Durable Graft at 12 Months Post Transplantation|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.|Approximately month 13|Intent to treat population includes participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant.||participants|||Number
148893|NCT00396383|Secondary|Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment|Platelet (PLT) engraftment was defined as a PLT count of ≥ 20*10^9/L for 7 days without transfusion. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants. One participant did not have PLT samples collected (included as 'unknown' in data table).||transplantations|Participants||Number
148894|NCT00396383|Secondary|Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment|Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1*10^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.|Approximately 2 months|Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants.||transplantations|Participants||Number
148895|NCT00396383|Primary|Participant Counts of Summarized Adverse Events (AE) During Treatment|Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).|1 month|All participants who received plerixafor||participants|||Number
148896|NCT00396383|Primary|Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg|Number of participants achieving a target of ≥ 4*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.|Day 1 up to day 4|All participants who received plerixafor||participants|||Number
148897|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 7|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 7-8 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng*h/mL||Standard Deviation|Mean
149195|NCT00394901|Primary|Mean Pain Scores at Week 8|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 8|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
148898|NCT00396331|Secondary|Area Under the Steady-state Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUC0-last) on Day 4|Area under the steady-state plasma concentration time curve from time zero to the last quantifiable sample after each plerixafor daily dose of 240 µg/kg, determined using the linear trapezoidal rule.|Days 4 -5 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng*h/mL||Standard Deviation|Mean
148899|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 7|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||Hours||Full Range|Median
148900|NCT00396331|Secondary|Time to Maximum Plasma Concentration (Tmax) on Day 4|Time to maximum plasma concentration (Tmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||Hours||Full Range|Median
148901|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 7 (following fourth plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng/mL||Standard Deviation|Mean
148902|NCT00396331|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 4|Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.|Day 4 (following first plerixafor administration)|Participants who provided blood samples for pharmacokinetic (PK) analysis.||ng/mL||Standard Deviation|Mean
148903|NCT00396331|Secondary|Number of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 5*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.||Participants|||Number
148904|NCT00396331|Secondary|Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Collected During Both Courses of Treatment With Plerixafor and G-CSF|Number of participants who had at least 2*10^6 CD34+ cells/kg collected by apheresis during both the first and the second courses of treatment together.|Day 5 up to Month 6 (up to 7 aphereses in each course of treatment)|Participants who received one course or two courses of plerixafor. Four NHL participants and 3 HD participants had two courses of plerixafor and the sum of CD34+ cells/kg collected in both courses is included.||Participants|||Number
148905|NCT00396331|Secondary|Number of Participants With Non-Hodgkin's Lymphoma (NHL) Who Had Evidence of Tumor Cell Mobilization After G-CSF or Plerixafor Administration|The number of participants with Bcl2 translocation in post-treatment samples.|Up to Day 7|"NHL participants with known follicular or transformed (follicular to diffuse large cell) lymphoma who provided samples for tumor cell mobilization analysis.~Outcome is not reported because there were insufficient samples for analysis."|||||
148906|NCT00396331|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 5*10^6 CD34+ cells/kg collected during up to 7 apheresis.|Day 5 to Day 11 (up to 7 aphereses)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had two courses of apheresis.||Proportion of Participants|||Number
148907|NCT00396331|Secondary|Number of Participants With Durable Engraftment 12 Months After Autologous Transplantation|The number of participants maintaining a durable graft 12 months after transplantation. A durable graft was defined as maintenance of normal blood counts: PLT >50*10^9/L without transfusion for at least 2 weeks prior to the visit; hemoglobin level >= 10 g/dL with no erythropoietin or transfusions for at least 1 month prior to the visit; and absolute neutrophil count (ANC) > 1,000 (1*10^9/L) with no G-CSF for at least 1 week prior to the visit.|Approximately 13 months (12 months post transplant )|Participants who received autologous stem cell transplantation and were evaluable 12 months post transplant. The 3 participants who did not have durable grafts included 2 participants whose PLT level never recovered to >50*10^9/L and 1 who had low hemoglobin at the 12-month visit.||Participants|||Number
148908|NCT00396331|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The number of days from transplantation to successful engraftment as measured by platelet value of >=20*10^9/L for 7 days without transfusion.|Approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PLT engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Four transplants (2 in participants with NHL and 2 in participants with MM) did not result in PLT engraftment and are therefore not included in the analysis.||Days|Participants|Full Range|Median
148909|NCT00396331|Secondary|Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|The number of days from transplantation to successful engraftment as measured by PMN >=0.5*10^9 /L for 3 days or >=1.0*10^9 /L for 1 day.|approximately 2 months (1 month post transplant)|Participants who received a transplant and had a successful PMN engraftment. Seven participants (4 with HD, 2 with MM, and 1 with testicular cancer) received a second transplant. Two transplants (1 in a participant with NHL and 1 in a participant with MM) did not result in PMN engraftment and are therefore not included in the analysis.||Days|Participants|Full Range|Median
148910|NCT00396331|Primary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|Proportion of participants who reached the target of at least 2*10^6 CD34+ cells/kg collected during up to 7 aphereses.|Day 5 to Day 11 (up to 7 apheresis)|Full analysis set of participants who received at least 1 dose of plerixafor. These results do not include results from the second course of plerixafor treatment and second course of apheresis for the 7 participants who had 2 courses of apheresis.||Proportion of Participants|||Number
148960|NCT00396201|Primary|Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to Day 9|Intent to treat population which included all participants who received plerixafor.||proportion of participants|||Number
148911|NCT00396331|Primary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period|Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately day 38|Safety population of all participants who received at least 1 dose of plerixafor.||Participants|||Number
148912|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 7 days post-treatment|Number of patients (from MITT population) with restored CVC function during the treatment period||percentage of participants|||Number
148913|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|Up to 120 minutes post-treatment (Dose 1 or Dose 2)|Modified intent to treat (MITT) population||percentage of participants|||Number
148914|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148915|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148916|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after second dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148917|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|30 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148918|NCT00396318|Secondary|Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|15 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148919|NCT00396318|Primary|Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase|Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg.|120 minutes after first dose|Modified intent to treat (MITT) population||percentage of participants|||Number
148920|NCT00396292|Primary|Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin||anytime between baseline and the end of study or time to intervention|Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being <11.0 g/dL||participants|||Number
148921|NCT00396279|Secondary|Number of Participants With Anti-Denosumab Antibodies|Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.|From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.|Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.||participants|||Number
148922|NCT00396279|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug.|From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months|All participants who received at least 1 dose of denosumab.||participants|||Number
148961|NCT00396162|Secondary|Mean Number of Days of Steroid Spray Use for Each Group||8 weeks|||days||Standard Deviation|Mean
148923|NCT00396279|Secondary|Serum Denosumab Trough Concentrations|Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.|The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point.||ng/mL||Standard Deviation|Mean
148924|NCT00396279|Secondary|Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)|Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).||percent change||Inter-Quartile Range|Median
148925|NCT00396279|Secondary|Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine|Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time.|Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81|Efficacy Analysis Set with available data at each time point (n).||percent change||Inter-Quartile Range|Median
148926|NCT00396279|Primary|Percentage of Participants With Giant Cell Tumor Response|A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent < 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis.|From enrollment until 25 weeks|The efficacy analysis set included participants with a Baseline histology assessment and at least 1 postdose histology assessment from weeks 5-25; or a Baseline radiology assessment and at least 1 postdose radiology assessment from weeks 5-25. Evaluable participants had to be on study for at least 28 days after administration of the first dose.||percentage of participants||95% Confidence Interval|Number
148927|NCT00396266|Secondary|Maximum Fold Increase in Peripheral Blood CD34+ Cells From Baseline Following Initial Administration of Plerixafor|A pharmacodynamic evaluation to determine the maximum fold increase in peripheral blood CD34+ cells following the initial administration of plerixafor by measuring the fold increase at time points up to 10 hours post plerixafor relative to baseline (immediately prior to plerixafor).|Day 4 (10 hours post first plerixafor dose)|Pharmacodynamic analysis was performed on a subgroup of participants from both treatment arms (1 NHL and 3 MM). The maximum fold increase was observed at 10 hours for all participants.||ratio||Full Range|Median
148928|NCT00396266|Secondary|Single-dose Apparent Volume of Distribution of Plerixafor (Vz/F) in NHL and MM Patients|Evaluation of Vz/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Vz/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||mL||Standard Deviation|Mean
148929|NCT00396266|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.||participants|||Number
148930|NCT00396266|Secondary|Single-dose Apparent Clearance of Plerixafor (CL/F)|Evaluation of Cl/F following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cl/F was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||mL/hour||Standard Deviation|Mean
148931|NCT00396266|Secondary|Single-dose Area Under the Concentration-time Curve of Plerixafor From Time 0 to 10 Hours Post-dose (AUC0-10)|Evaluation of AUC0-10 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. AUC0-10 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||ng•h/mL||Standard Deviation|Mean
148932|NCT00396266|Secondary|Single-dose Half-life of Plerixafor (T1/2)|Evaluation of T1/2 following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. T1/2 was determined from non-compartmental analysis.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||hours||Standard Deviation|Mean
148933|NCT00396266|Secondary|Single-dose Time to Maximum Concentration of Plerixafor (Tmax)|Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||hours||Full Range|Median
148934|NCT00396266|Secondary|Single-dose Maximum Observed Concentration of Plerixafor (Cmax)|Evaluation of Cmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Cmax was determined from direct observation of the data.|Day 5 - 0 to 10 hours post-first plerixafor dose.|Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).||ng/mL||Standard Deviation|Mean
148935|NCT00396266|Secondary|Tumor Cell Mobilization in Non-Hodgkin's Lymphoma (NHL) Participants Following Plerixafor Treatment|In a subpopulation of NHL participants, the mobilization of NHL cells was to be evaluated. None of the samples were analyzed due to sample degradation.|Prior to the first (Day 4) and last dose of plerixafor, immediately prior to each apheresis, and 24 hours after the last apheresis.|This analysis was not performed due to sample degradation.|||||
148962|NCT00396162|Secondary|Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks)|Mean number of days that antibiotics were used in the subgroup (placebo vs Probiotic arm)|At 8 weeks after baseline measures|||days||Standard Deviation|Mean
148936|NCT00396266|Secondary|Number of Transplants Resulting In Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post-Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population of participants who had transplants. One participant received a tandem transplant.||number of transplants|Participants||Number
148937|NCT00396266|Secondary|Number of Participants Who Had a ≥ 2-fold Increase in Circulating CD34+ Cells|To determine if NHL and MM patients mobilized with G-CSF (10 µg/kg QD) plus plerixafor will have a ≥2-fold increase in circulating CD34+ cells from time 0 to 11 hours after a dose of plerixafor.|Time 0 to 11 hours after the first dose of plerixafor|"The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).~One participant excluded from the analysis because data was missing."||participants|||Number
148938|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of HD at Visit 2|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 2 – BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1).|Subjects in the MITT Population Treated with Extended-Dwell Tenecteplase at Visit 1||mL/minute||Standard Deviation|Mean
148939|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With a Urea Reduction Ratio ≥ 65% at Visits 2 and 3|"Patients who experienced treatment failure at the end of Visit 1 and were eligible for and treated with extended-dwell tenecteplase at Visit 1 were assessed for Urea Reduction Ratio (URR) at Visits 2 and 3. URR was calculated from blood urea nitrogen (BUN) measurements according to the following:~(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|Blood urea nitrogen measurements were taken prior to HD and at the end of HD at Visits 2 (2nd HD session, within 72 hours after visit 1) and 3 (3rd HD session, within 72 hours of Visit 2)|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.||percentage of participants||95% Confidence Interval|Number
148940|NCT00396253|Secondary|Percentage of Participants Who Failed Treatment at Visit 1 With Treatment Success at Visit 2|Patients who failed treatment at Visit 1 and were treated with extended-dwell tenecteplase were analyzed for Treatment Success at Visit 2. Treatment success at Visit 2 was defined as a BFR ≥ 300 mL/min, without line reversal, and increase of ≥ 25 mL/min from baseline BFR, at an associated target arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of HD and at the end of HD.|BFR was measured 30 minutes before the end of HD and at the end of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1). Baseline BFR was measured at the beginning of HD at Visit 1.|Subjects in the MITT Population who were Treated with Extended-Dwell Tenecteplase at Visit 1.||percentage of participants||95% Confidence Interval|Number
148941|NCT00396253|Secondary|Change in Blood Flow Rate From Baseline to the End of Hemodialysis at Visit 1|Change in Blood flow rate (BFR) is the BFR at the end of HD for Visit 1 – BFR at Baseline.|Baseline (beginning of HD at Visit 1) to the end of HD at Visit 1.|Modified intent to treat (MITT) population||mL/min||Standard Deviation|Mean
148942|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 2|"The urea reduction ratio (URR) at Visit 2 was calculated for those participants who did not receive extended-dwell tenecteplase at Visit 1 from measurements of blood urea nitrogen (BUN) as follows:~(Pre-HD BUN) − (Post-HD BUN) * 100% / (Pre-HD BUN)"|At Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) samples for blood urea nitrogen measurements were taken prior to HD and after HD was completed.|Modified intent to treat (MITT) population who did not receive extended-dwell tenecteplase at Visit 1.||percentage of participants||95% Confidence Interval|Number
148943|NCT00396253|Secondary|Percentage of Participants With Urea Reduction Ratio ≥ 65% at Visit 1|"The urea reduction ratio (URR) was calculated from measurements of blood urea nitrogen (BUN) as follows:~(Pre-treatment BUN) − (Post-HD BUN) * 100% / (Pre-treatment BUN)~Pre-treatment URR was assessed within 30–60 minutes after the initiation of HD and does not represent a true baseline value."|At Visit 1 (first hemodialysis session in which treatment was administered) samples for blood urea nitrogen measurements were taken at the beginning of HD (prior to treatment administration) and after HD was completed.|Modified intent to treat (MITT) population||percentage of participants||95% Confidence Interval|Number
148944|NCT00396253|Secondary|Percentage of Participants Who Maintained Catheter Function at Visits 2 and 3|For patients with treatment success at Visit 1 or Visit 2, maintenance of catheter function at subsequent visits was defined as a BFR ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated target arterial pressure in the range of 0 to -280 mmHg at the beginning of that HD session (within the first 30 minutes).|Maintenance BFR measurements were taken at the beginning of HD at Visit 2 (2nd consecutive HD session, within 72 hours of Visit 1) and Visit 3 (3rd consecutive HD session, within 72 hours of Visit 2).|Modified intent to treat (MITT) population, who had treatment success at Visit 1. The n equals the number of subjects who had treatment success at Visit 1 and had assessment of catheter function for the given visit or who had a missing assessment due to starting the Retreatment course.||percentage of participants||95% Confidence Interval|Number
148945|NCT00396253|Primary|Targeted Adverse Events From the Initial Study Drug Administration Through the Start of Visit 2 or Until Instillation of Extended-Dwell Tenecteplase|The primary outcome measure was the number of targeted adverse events, occurring from initial study drug administration through the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for subjects who did not receive open-label, extended-dwell tenecteplase, from initial study administration through the start of Visit 2. Targeted adverse events were defined as intracranial hemorrhage, major bleeding and embolic events, thrombosis, Catheter-related blood stream infection (CRBSIs), and catheter-related complications.|From initial study drug administration to the end of Visit 1 (prior to administration of open-label, extended-dwell tenecteplase) or, for patients who did not receive extended-dwell tenecteplase, from initial study administration to the start of Visit 2.|Modified intent to treat (MITT) population||Events|||Number
148963|NCT00396162|Secondary|Side Effect Summary|Totals of all side effects for placebo group and treatment group over the course of the eight week trial (including patients who dropped from the study after baseline measurement). Individual categories of side-effects are listed in Adverse events section.|8 weeks|The sample size on the placebo side is reduced due to some study participants not reporting their 8 week survey||participants|||Number
148946|NCT00396253|Primary|Percentage of Participants Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as Blood Flow Rate (BFR) ≥ 300 mL/min and an increase of ≥ 25 mL/min from baseline BFR (without reversal of lines), at an associated arterial pressure in the range of 0 to −280 mmHg, 30 (± 10) minutes prior to the end of hemodialysis and at the end of hemodialysis.|Visit 1 (the first hemodialysis session in which treatment was administered). BFR was measured at the beginning of hemodialysis (Baseline measurement) and at 30 minutes prior to the end of hemodialysis and at the end of hemodialysis.|Modified intent to treat (MITT) population, consisting of all enrolled patients who received at least one dose of study drug (tenecteplase).||Percentage of participants|||Number
148947|NCT00396201|Secondary|Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor|The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||mL||Standard Deviation|Mean
148948|NCT00396201|Secondary|Apparent Clearance (CL/F) of Single-dose Plerixafor|Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).|Day 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||mL/hr||Standard Deviation|Mean
148949|NCT00396201|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor|Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.|Days 4-5|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||ng*hr/mL||Standard Deviation|Mean
148950|NCT00396201|Secondary|Half-life (T1/2) Following a Single Dose of Plerixafor|Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||hours||Standard Deviation|Mean
148951|NCT00396201|Secondary|Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor|Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||hours||Standard Deviation|Mean
148952|NCT00396201|Secondary|Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor|Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.|Day 4|The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.||ng/mL||Standard Deviation|Mean
148953|NCT00396201|Secondary|Number of Participants With a Durable Graft at 12 Months|Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.|13 months|Intent to treat population which included all participants who received plerixafor and had a transplant.||participants|||Number
148954|NCT00396201|Secondary|Number of Days Post Transplantation to Platelet (PLT) Engraftment|Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant. One participant's time to engraftment was unknown due to missing lab values.||days||Full Range|Median
148955|NCT00396201|Secondary|Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment|Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13 (up to 12 months post transplant)|Intent to treat population which included all participants who received plerixafor and had a transplant.||days||Full Range|Median
148956|NCT00396201|Secondary|Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg|Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor and achieved a target of ≥5*10^6 CD34+cells/kg||participants|||Number
148957|NCT00396201|Secondary|Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population which included all participants who received plerixafor and had pre- and post-plerixafor CD34+ cell counts available; 3 participants had missing results data and were not included.||ratio||Standard Deviation|Mean
148958|NCT00396201|Secondary|Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF|The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories.|Day 5 up to day 9|Intent to treat population which included all participants who received plerixafor.||proportion of participants|||Number
148959|NCT00396201|Secondary|Overall Participant Counts of Adverse Events During the Treatment Period|"Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant.~See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious."|Day 0 - approximately day 38|Safety population consisting of all participants who received G-CSF and/or plerixafor.||participants|||Number
148964|NCT00396162|Primary|Mean Reduction in SNOT-20 Scores|Mean reduction (and Standard deviation) in SNOT-20 scores, from baseline to 8 week measurements. SinoNasal Outcome Test measures symptom severity. It is a summary score, ranging from 0 to 100 with 100 indicating worse symptoms. Since 100 represents more severe symptoms, the changes represented here are reductions in SNOT-scores, even though they are not expressed as negative numbers.|8 weeks|||units on a scale||Standard Deviation|Mean
148965|NCT00396136|Primary|Safety of the COROX OTW Steroid LV Pacing Lead|Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.|3 years post implant|All study participants.||participants|||Number
148966|NCT00396136|Primary|Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing|Evaluate threshold voltage of the COROX OTW Unipolar Lead.|All follow-ups for 3 years post implant|All study participants.||Threshold Voltage|Participants|Standard Deviation|Mean
148967|NCT00396097|Secondary|Change From Baseline in Height SDS at 48 Months.|Change in height SDS was measured at 48 months.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||Standard Deviation Score (SDS)||Standard Deviation|Mean
148968|NCT00396097|Secondary|Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months|The estimated cost of long-term height gain until FAH was calculated.|4 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||mg/cm||Standard Deviation|Mean
148969|NCT00396097|Secondary|Computed Cost of Height Gain at 48 Months|The computed cost of height gain was defined as the amount of drug used relative to the observed height-gain, in terms of mg/cm, this was calculated at Month 48.|4 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||mg/cm||Standard Deviation|Mean
148970|NCT00396097|Secondary|Time Cost (Months Until >= -2 SDS)|Time cost was defined as the number of months needed until height SDS was within the normal limit (ie, >= -2SDS).|2 years|Full analysis set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available.||Months||95% Confidence Interval|Median
148971|NCT00396097|Secondary|Variability of Height SDS at 24 Months|The continuous endpoint of variability of height SDS at 24 months was defined as the SD of the 24 month height SDS.|2 years|FAS included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. LOCF rule was applied to impute Month 24 missing height SDS data.||Standard Deviation Score (SDS)||Standard Deviation|Mean
148972|NCT00396097|Primary|Absolute On-target Difference (AOTD) at 24 Months|This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or –1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).|2 years|The Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline height SDS value available. Last observation carried forward (LOCF) rule was applied to impute Month 24 missing height SDS data.||Standard Deviation Score (SDS)||Standard Deviation|Mean
148973|NCT00396084|Secondary|Percent Dosing Interval Above Minimum Inhibitory Concentration (MIC)|Determined by linear extrapolation of concentration-versus-time curve to intersection with MIC.|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||Percentage||Inter-Quartile Range|Mean
148974|NCT00396084|Secondary|Area Under the Curve (AUC) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC)|Area Under the Curve 0-12 (AUC 0-12) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC) and AUC 0-24/MIC|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/h/ml||Inter-Quartile Range|Median
148975|NCT00396084|Secondary|Area Under the Curve (AUC) During First 12 and 24 Hours Adjusted for Free Drug Concentrations|Median pharmacodynamic parameters (range) adjusted for free drug concentrations. AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/h/ml||Inter-Quartile Range|Median
148976|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC) Adjusted for Free Drug Concentrations||Day 5 (7 time points)|Twenty-nine patients underwent pharmacodynamic sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/ml||Inter-Quartile Range|Median
148977|NCT00396084|Secondary|Maximum Plasma Drug Concentrations (Cmax), Adjusted for Free Drug Concentration|Cmax adjusted for free drug concentrations after 5 days of monotherapy with study drugs|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/ml||Full Range|Median
148978|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve During First 12 and 24 Hours|Median pharmacokinetic parameters (range). AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively|Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||ug/h/ml||Full Range|Median
148979|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||hours||Full Range|Median
148981|NCT00396084|Secondary|Area Under the Curve During First 12 or 24 Hours / Minimum Inhibitory Concentration (AUC/MIC)|Area Under the Curve (AUC) During First 12 or 24 Hours /Minimum Inhibitory Concentration. AUC reflects total drug (bound and unbound). MIC values were determined using protein-containing media.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling||ug/ml||Inter-Quartile Range|Median
148982|NCT00396084|Secondary|Pharmacokinetic Parameters: Area Under the Curve (AUC) During First 12 and 24 Hours|Area under the curve (AUC), from time 0-12 hours for INH or 0-24 hours for gatifloxacin, levofloxacin, and moxifloxacin.|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||ug/h/ml||Full Range|Median
148983|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Linezolid Once Daily/Linezolid Twice Daily/INH Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|One patient in the INH arm discontinued the study drug after 5 days. Days 3 and 7 cultures for another patient in the INH arm were contaminated and cfu data are not available for this patient. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||log10 cfu/ml||Standard Deviation|Mean
148984|NCT00396084|Secondary|Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC)||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||ug/ml||Inter-Quartile Range|Median
148985|NCT00396084|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) and Half-life||Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||hours||Full Range|Median
148986|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Linezolid Once Daily/Linezolid Twice Daily/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum cfu (expressed in log10 units) during the first 2 days of monotherapy. Mean values for the 3 treatment groups were compared.|Day 0 to Day 2 Monotherapy|EBA 0-2 comparisons across groups were done for 29 patients. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.||log10 cfu/ml/day||Standard Deviation|Mean
148987|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming unit (cfu) for each day on treatment was calculated for patients in the INH arm and those in the Linezolid once daily and Linezolid twice daily arms. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 29 patients. One patient in the linezolid twice daily arm withdrew after randomization before receiving any doses of study drug.||Percentage||Standard Deviation|Mean
148988|NCT00396084|Primary|Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Fluoroquinolones/Isoniazid (INH) Comparison|The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.|Day 2 to Day 7 Monotherapy|A total of 38 patients were analyzed for Early Bactericidal Activity (EBA) Days 2-7. One patient in the moxifloxacin arm discontinued the study drug after 4 days. One patient in the INH arm discontinued the study drug after 6 days.||log10 cfu/ml/day||Standard Deviation|Mean
148989|NCT00396084|Primary|Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Fluoroquinolones/Isoniazid (INH) Comparison|Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum colony forming units (cfu) (expressed in log10 units) during the first 2 days of monotherapy.|Day 0 to Day 2 Monotherapy|Early bactericidal activity (EBA 0-2) was calculated for 10 subjects per treatment arm (n=40).||log10 cfu/ml/day||Standard Deviation|Mean
148990|NCT00396084|Secondary|Maximum Plasma Drug Concentration (Cmax)|Maximum plasma concentration, given sampling scheme|Day 5 (7 time points)|Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.||ug/ml||Full Range|Median
148991|NCT00396084|Secondary|Sputum Cytokine Proteins - Results Are Pending.||Study drug administration duration||||||
148992|NCT00396084|Secondary|Sputum mRNA Clearance Rate - Results Are Pending.||Study drug administration duration||||||
148993|NCT00396084|Primary|Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)|The adjusted area under the curve (aAUC) for sputum colony forming units (cfu) for each day on treatment was calculated. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.|Study drug administration duration - 7 days monotherapy|The aAUC was calculated for 10 subjects per treatment arm (n=40).||Percentage||Standard Deviation|Mean
148994|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Open-label Tenecteplase at Visit 2)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with open-label tenecteplase at Visit 2||percentage of success|||Number
148995|NCT00396032|Secondary|Percentage of Subjects Who Had Treatment Success With Respect to BFR at Visit 2 (MITT Population With Extended Dwell Tenecteplase at Visit 1)|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 2 of consecutive HD treatments|MITT population with extended-dwell tenecteplase at Visit 1||percentage of success|||Number
148998|NCT00396032|Primary|Percentage of Subjects Who Had Treatment Success With Respect to Blood Flow Rate (BFR) at Visit 1|Treatment success is defined as BFR of ≥300 mL/min and an increase from baseline BFR of ≥25 mL/min at an associated target arterial pressure in the range of 0 to -280 mmHg 30 (±10) minutes prior to the end of HD and at the end of HD.|Visit 1 of HD treatment|Modified intent to treat (MITT) population||percentage of success|||Number
148999|NCT00396006|Secondary|Clinically Significant Changes in Vital Signs From Pre- to Post-Infusion|"Clinically significant changes in vital signs from pre- to post-infusion are:~Heart rate: 25% increase above pre-infusion value~Blood pressure: ≥ 30 mm Hg change from pre-infusion blood pressure (systolic or diastolic)~Temperature: an increase in body temperature to >38°C (>100.4°F). If the pre-infusion body temperature was already >38°C (>100.4°F), then any further increase in body temperature by 1.1°C (1.98°F) or more was considered clinically significant.~Respiratory rate: 25% increase above pre-infusion value"|During 8 consecutive weeks of infusion|Intention to treat||# Clinically significant events|||Number
149000|NCT00396006|Primary|Number of Changes in the Rate of Infusion|Number of decreases in the rate or discontinuations of infusion at 0.2 mL/kg/min|During 8 consecutive weeks of treatment|||infusions|||Number
149001|NCT00396006|Other Pre-specified|Change in the BAL ELF Tumor Necrosis Factor-alpha (TNF-α) From Baseline to Post-treatment|Median change in the BAL ELF TNF-α from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures|||||
149002|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Interleukin 8 (IL-8) Level|Median ratio of post- to pre-treatment BAL ELF IL-8 Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||pg/mL||Full Range|Median
149003|NCT00396006|Other Pre-specified|Ratio of Post- to Pre-treatment BAL ELF Total Neutrophil Elastase Level|Median ratio of post- to pre-treatment BAL ELF Total Neutrophil Elastase Level|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||nM||Full Range|Median
149004|NCT00396006|Other Pre-specified|Change in the BAL ELF Free Neutrophil Elastase Level|Median change in the BAL ELF Free Neutrophil Elastase Level from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol population with both pre- and post-treatment analytes available from BAL procedures||nM||Full Range|Median
149005|NCT00396006|Secondary|Change in the Plasma Antineutrophil Elastase Capacity (ANEC) Level|Mean change in the plasma ANEC level from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol||μM||Standard Deviation|Mean
149006|NCT00396006|Secondary|Change in the α1-PI Plasma Level|Mean change in the plasma level of α1-PI from baseline to post-treatment|Blood samples were collected at baseline and after 8 consecutive weeks of treatment|Per protocol||μM||Standard Deviation|Mean
149007|NCT00396006|Secondary|Change in in the Ratio of BAL ELF α1-PI to Human Neutrophil Elastase (HNE) Complex Concentration|Median change in the ratio of BAL ELF α1-PI to HNE complex concentration from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|No per protocol subject had both pre- and post-treatment analytes available, therefore no analysis could be performed on this outcome measure|||||
149008|NCT00396006|Secondary|Ratio of Post- to Pre-treatment BAL ELF Antineutrophil Elastase Capacity (ANEC) Levels|Median ratio of post- to pre-treatment BAL ELF ANEC levels|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||μM||Full Range|Median
149009|NCT00396006|Primary|The Number of Adverse Events (AEs) Related to the Infusion of ARALAST Fr. IV 1 Administered at a Rate of 0.2 mL/kg/Min||During 8 consecutive weeks of treatment|Intent to treat||adverse events|||Number
149010|NCT00396006|Primary|Change in Bronchoalveolar Lavage (BAL) Epithelial Lining Fluid (ELF) Alpha1-Proteinase Inhibitor (α1-PI) Level|Median change BAL ELF antigenic α1-PI level the from baseline to post-treatment|BAL procedures were performed at baseline and after 8 consecutive weeks of treatment (minimum of 12 weeks)|Per protocol||μM||Full Range|Median
149011|NCT00395993|Primary|Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL||Any time between baseline and the end of study or time to intervention|Modified Intent-to-Treat Population defined as subjects from the Safety Population who received at least 1 dose of study medication, had average baseline hemoglobin, TSAT, and ferritin levels, had heavy uterine bleeding, and had at least 1 post-baseline hemoglobin assessment.||participants|||Number
149012|NCT00395967|Secondary|Graft Durability at 12 Months After Transplantation|"Participants with durable grafts. Graft durability was assessed by complete blood count (CBC) and differential analysis at 12 months post-transplantation.~This study was terminated early and analysis was not done."|13 months|This study was terminated early and analysis was not done.|||||
149013|NCT00395967|Secondary|Number of Days to Platelet (PLT) Engraftment|"The median number of days to platelet (PLT) engraftment criteria was ≥ 20*10^9/L platelets without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that criteria were met.~This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.|||||
149014|NCT00395967|Secondary|Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment|"The median number of days to PMN engraftment criteria was PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that criteria were met.~This study was terminated early and analysis was not done."|2 months|This study was terminated early and analysis was not done.|||||
149015|NCT00395967|Secondary|The Fold Increase in Peripheral Blood CD34+ Cells Following the First Dose of Plerixafor|"The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and expressed as a ratio. Fold increase = pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).~This study was terminated early and analysis was not done."|Days 5-6|This study was terminated early and analysis was not done.|||||
149054|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
149016|NCT00395967|Secondary|Overall Participants Counts of Adverse Events|Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|up to 13 months|Safety Population defined as all participants who received G-CSF and/or plerixafor.||participants|||Number
149017|NCT00395967|Primary|Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days|The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.|approximately days 6-9|All patients who received plerixafor.||participants|||Number
149018|NCT00395642|Primary|Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted.|Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.|6 months|All Enrolled Participants||Percent of days|||Number
149019|NCT00395629|Secondary|Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)|A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.|4, 8, 12, 16, 20, and 24 weeks|Per-protocol population included all participants of the safety population; who received at least one dose of study drug within the core study and had at least one safety assessment, and who did not have any major protocol deviation. n in each of the Categories is the number of participants in each arm/group who had data for that time point.||µmol/L||Standard Deviation|Mean
149020|NCT00395629|Primary|Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)|Mean absolute change in serum ferritin from baseline to the end of the extension study.|0 to 48 weeks|Extension Per-protocol population including all participants of the per protocol population who also were part of the extension safety population.||µg/L||Standard Deviation|Mean
149021|NCT00395512|Secondary|Change From Baseline in Mean HDL Particle Size|Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
149022|NCT00395512|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||µmol/L||Standard Error|Least Squares Mean
149023|NCT00395512|Secondary|Change From Baseline in Mean LDL Particle Size|Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
149024|NCT00395512|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
149025|NCT00395512|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles|"The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
149026|NCT00395512|Secondary|Change From Baseline in Mean VLDL Particle Size|Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nm||Standard Error|Least Squares Mean
149027|NCT00395512|Secondary|Change From Baseline in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
149055|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
149028|NCT00395512|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149029|NCT00395512|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
149030|NCT00395512|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides|Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149031|NCT00395512|Secondary|Change From Baseline in Apolipoprotein C-III|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149032|NCT00395512|Secondary|Change From Baseline in Apolipoprotein B|Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149033|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A2|Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149034|NCT00395512|Secondary|Change From Baseline in Apolipoprotein A1|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149035|NCT00395512|Secondary|Change From Baseline in Adiponectin|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
149036|NCT00395512|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein|Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/L||Standard Error|Least Squares Mean
149037|NCT00395512|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1|Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
149038|NCT00395512|Secondary|Change From Baseline in Free Fatty Acids|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
149039|NCT00395512|Secondary|Change From Baseline in Triglyceride Levels|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149040|NCT00395512|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149196|NCT00394901|Primary|Mean Pain Scores at Week 7|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 7|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149041|NCT00395512|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149042|NCT00395512|Secondary|Change From Baseline in Total Cholesterol Level|Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149043|NCT00395512|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.|Baseline and Weeks 8, 12, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||kg||Standard Error|Least Squares Mean
149044|NCT00395512|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5~The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
149045|NCT00395512|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5~A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate."|Baseline and Weeks 12 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
149046|NCT00395512|Secondary|Change From Baseline in C-peptide Levels|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
149047|NCT00395512|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||ratio||Standard Error|Least Squares Mean
149048|NCT00395512|Secondary|Change From Baseline in Insulin|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||μIU/mL||Standard Error|Least Squares Mean
149049|NCT00395512|Secondary|Change From Baseline in Fasting Proinsulin|Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
149050|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
149051|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
149052|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
149053|NCT00395512|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%.|Baseline and Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
149056|NCT00395512|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%.|Week 26|Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
149057|NCT00395512|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:~After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L);~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L);~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c."|Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with visits during or after the specified interval in each treatment group.||percentage of participants|||Number
149058|NCT00395512|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.|Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set including patients with at least one non-missing fasting plasma glucose result in the specified interval in each treatment group.||percentage of participants|||Number
149059|NCT00395512|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
149060|NCT00395512|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|Baseline and Weeks 4, 8, 12, 16 and 20.|The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
149061|NCT00395512|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|The Full analysis Set (all randomized patients who took at least 1 dose of double-blind study drug) where a Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
149062|NCT00395486|Secondary|Percentage Change of Apolipoprotein B (ApoB)|Calculate the percentage change of apolipoprotein B|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
149063|NCT00395486|Secondary|Percentage Change of Apolipoprotein A1 (ApoA1)|Calculate the percentage change of Apolipoprotein A1|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
149064|NCT00395486|Secondary|Percentage Change of Triglycerides (TG)|Calculate the percentage change of Triglycerides.|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
149065|NCT00395486|Secondary|Percentage Change of High-Density Lipoprotein-C (HDL-C)|Calculate the percentage change of HDL-C level|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
149066|NCT00395486|Secondary|Percentage Change of Total Cholesterol (TC)|Calculate the percentage change of total cholesterol level|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
149067|NCT00395486|Secondary|Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)|Calculate the percentage reduction of LDL-C|Baseline and 6 weeks|||percentage reduction||Standard Deviation|Mean
149068|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using QUICKI|QUICKI was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: QUICKI = 1/[log(insulin) + log(glucose)].|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
149069|NCT00395486|Secondary|Percentage Change of Insulin Resistance Using HOMA-R|HOMA-R was calculated using insulin and glucose levels derived by laboratory test. The formula is as following: HOMA-R = insulin* glucose/22.5|Baseline and 6 weeks|||percentage change||Standard Deviation|Mean
149070|NCT00395486|Secondary|Percentage Change of Glucose Level|Using laboratory test, mean change of glucose level was investigated.|Baseline and 6 weeks|||Percentage change||Standard Deviation|Mean
149071|NCT00395486|Secondary|Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C & non HDL-C target goal.|Baseline and 6 weeks|||percentage of participants|||Number
149072|NCT00395486|Secondary|Percentage of Subjects Reaching Their LDL-C Target Goal|Based on NCEP ATP III guideline, calculate the percentage of subjects reaching their LDL-C target goal. LDL-C target goals are <70mg/dl, <100mg/dl and <130mg/dl according to their baseline conditions (presence of Coronary heart disease and risk factors and grade of Framingham 10-Year risk).|Baseline and 6 weeks|||percentage of participants|||Number
149073|NCT00395486|Primary|Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6|Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.|Baseline and 6 weeks|||percent change||Standard Deviation|Mean
149074|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with CNS lesions other than primary malignant brain tumor(s) / brain metastases||Lesions||Standard Deviation|Mean
149075|NCT00395460|Other Pre-specified|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Subgroup: participants with primary malignant brain tumor(s) / brain metastases||Lesions||Standard Deviation|Mean
149076|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion – SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with CNS lesions other than primary malignant brain tumor(s) / brain metastases. 1 (Gadavist) and 2 participants (Magnevist) had missing values for signal intensity for CNS lesions pre- and post-contrast and could not be considered for evaluation.||Contrast to Noise ratio||Standard Deviation|Mean
149077|NCT00395460|Other Pre-specified|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases|CNR = (SI lesion – SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All valid case participants who received contrast injection. Subgroup: those with primary malignant brain tumor(s) / brain metastases. One participant in the Gadavist group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.||Contrast to Noise ratio||Standard Deviation|Mean
149078|NCT00395460|Secondary|Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions|Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.||Lesion delineation score||Standard Deviation|Mean
149079|NCT00395460|Secondary|Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI|The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Lesion contrast enhancement of 1 participant in the Gadavist group was assessed by the investigator (but not the blinded readers) as 'not applicable'.||Contrast enhancement score||Standard Deviation|Mean
149080|NCT00395460|Secondary|Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment|The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as “improved”, “unchanged” or “worsened” for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases.||Participants|||Number
149081|NCT00395460|Secondary|Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan|The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases||Lesions||Standard Deviation|Mean
149082|NCT00395460|Primary|Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions|CNR = (signal intensity [SI] lesion – SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.|Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)|Per Protocol Set (PPS): All patients who have received contrast injection and are not invalid cases. Two participants in each treatment group had missing values for signal intensity for central nervous system lesions at pre- and post-contrast and could thus not be considered for evaluation.||Contrast to Noise ratio||Standard Deviation|Mean
149124|NCT00395161|Primary|The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.||48 hours after admission until 5 days after discharged from the PICU|Intention to treat analysis of all randomized patients.||Days||95% Confidence Interval|Median
149125|NCT00395135|Secondary|Year 2: Percent Change in Body Weight From Week 52 to Week 104|Year 2: The % change in body weight (kg) from week 52 to week 104.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
149083|NCT00395447|Primary|Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With a Planned Lead Revision or Addition (Planned System Modification)|The percentage of subjects experiencing one of the pre-defined complications is presented. The percentage of subjects experincing a complication is presented separately for subjects with a straight-forward device replacment (generator replacement procedure plan did not include a lead addition or revision) and subjects with a planned system modification (generator replacement procedure plan did include a lead addition or revision).|6 months|||Percentage of participants (%)||95% Confidence Interval|Mean
149084|NCT00395343|Other Pre-specified|Change From Baseline in A1C at Week 24|"A1C in subset of patients on long-acting or intermediate-acting insulin.~A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included the subset of patients on long-acting or intermediate-acting insulin with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
149085|NCT00395343|Secondary|Percent of Patients With A1C < 6.5% at Week 24||Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent|||Number
149086|NCT00395343|Secondary|Percent of Patients With A1C < 7.0% at Week 24||24 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent|||Number
149087|NCT00395343|Secondary|Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24|Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.)|Baseline and Week 24|The Full Analysis Set (FAS) included all patients who participated in the 10-point meal tolerance test and had a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
149088|NCT00395343|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
149089|NCT00395343|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
149090|NCT00395343|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
149091|NCT00395304|Secondary|Adverse Events||Measured during each 16-week treatment period||||||
149092|NCT00395304|Secondary|Time Until First Asthma Exacerbation||Measured during the last 12 weeks of each 16-week treatment period||||||
149093|NCT00395304|Secondary|Asthma Quality of Life||Measured during the last 12 weeks of each 16-week treatment period||||||
149094|NCT00395304|Secondary|Asthma Control Test||Measured during the last 12 weeks of each 16-week treatment period||||||
149095|NCT00395304|Secondary|Exhaled Nitric Oxide||Measured during the last 12 weeks of each 16-week treatment period||||||
149096|NCT00395304|Secondary|Methacholine PC20||Measured during the last 12 weeks of each 16-week treatment period||||||
149097|NCT00395304|Secondary|Impulse Oscillometry||Measured during the last 12 weeks of each 16-week treatment period||||||
149098|NCT00395304|Secondary|PEFR Variability||Measured during the last 12 weeks of each 16-week treatment period||||||
149099|NCT00395304|Secondary|Evening PEFR||Measured during the last 12 weeks of each 16-week treatment period||||||
149100|NCT00395304|Secondary|Morning Peak Expiratory Flow Rate (PEFR)||Measured during the last 12 weeks of each 16-week treatment period||||||
149101|NCT00395304|Secondary|FEV1/FVC||Measured during the last 12 weeks of each 16-week treatment period||||||
149102|NCT00395304|Secondary|Forced Vital Capacity (FVC)||Measured during the last 12 weeks of each 16-week treatment period||||||
149103|NCT00395304|Secondary|Post-bronchodilator Forced FEV1||Measured during the last 12 weeks of each 16-week treatment period||||||
149104|NCT00395304|Secondary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)||Measured during the last 12 weeks of each 16-week treatment period||||||
149126|NCT00395135|Secondary|Year 1: Percent Change in Body Weight From Baseline to Week 52|Year 1: The % change in body weight (kg) from baseline to week 52.|52 weeks|MITT with LOCF||% change from baseline: body wt (kg)||Standard Error|Least Squares Mean
149127|NCT00395135|Primary|Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104|The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.|104 weeks|MITT with LOCF||percentage of participants|||Number
149197|NCT00394901|Primary|Mean Pain Scores at Week 6|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 6|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149105|NCT00395304|Primary|The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.|One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.|Measured during the last 12 weeks of each 16-week treatment period|ITT. Although only 157 participants completed all three treatment periods, there was sufficient data on 8 additional participants to include them in the analysis of the primary outcome.||Participants|||Number
149106|NCT00395291|Secondary|Change in Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and lab results were available for all 22.||pg/ml||Standard Deviation|Mean
149107|NCT00395291|Secondary|Change in Adiponectin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Adiponectin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||ng/ml||Standard Deviation|Mean
149108|NCT00395291|Secondary|Change in Esterase After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Esterase levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions and results were available.||units/ml||Standard Deviation|Mean
149109|NCT00395291|Secondary|Change in IL-10 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-10 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/ml||Standard Deviation|Mean
149110|NCT00395291|Secondary|Changes in the Following Level: IL-6|Change in IL-6 after 30 days of intervention.|After the subject has comleted their last visit|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/mL||Standard Deviation|Mean
149111|NCT00395291|Secondary|Change in IL-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IL-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/ml||Standard Deviation|Mean
149112|NCT00395291|Secondary|Change in CRPs After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the CRPs levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.||mg/ml||Standard Deviation|Mean
149113|NCT00395291|Secondary|Change in TNF-alpha After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the TNF-alpha levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects had samples available for the MK-0677 intervention, and 21 samples were available for the placebo intervention.||pg/ml||Standard Deviation|Mean
149114|NCT00395291|Secondary|Change in Des-Acyl Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Des-Acyl Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions.||pg/ml||Standard Deviation|Mean
149115|NCT00395291|Secondary|Change in Insulin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Insulin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.||uIU/ml||Standard Deviation|Mean
149116|NCT00395291|Secondary|Change in Leptin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Leptin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 subjects completed both interventions.||ng/ml||Standard Deviation|Mean
149117|NCT00395291|Secondary|Change in Acyl-Ghrelin After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the Acyl-Ghrelin levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention.|22 subjects completed both interventions.||pg/ml||Standard Deviation|Mean
149118|NCT00395291|Primary|Change in IGF-1 After 30 Days of Intervention Compared to Baseline Level.|Looking for a change in the IGF-1 levels after the subject has been on intervention for 30 days compared to baseline levels.|Baseline and after 30 days of intervention|22 Subjects completed both interventions and lab results were available.||ng/ml||Standard Deviation|Mean
149119|NCT00395226|Primary|Severity of Facial Rosacea After 90 Days of Treatment|Modified Rosacea Severity Scoring System evaluating four signs of rosacea, flushing (transient erythema or redness), erythema (redness), papules and pustules and telangiectasia (spider-veins) ranges from 0 (best, absent) to 12 (worst, severe on all items)|90 days|||units on scale 0 to 12||95% Confidence Interval|Mean
149120|NCT00395161|Secondary|All-cause 28-day Mortality Rate.||28 days after admission to the PICU|This safety outcome was analyzed by treatment received, among a total of 284 children who received treatment and had known 28-day status.||participants|||Number
149121|NCT00395161|Secondary|Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)|What is reported is the number of participants with counts qualifying as lymphopenia.|from time of PICU admission till discharge from PICU|All randomized patients (intention to treat analysis)||participants|||Number
149122|NCT00395161|Secondary|Antibiotic-free Days||48 hours after admission until PICU discharge|All randomized patients per intention to treat analysis||Days||Inter-Quartile Range|Median
149123|NCT00395161|Secondary|Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days||48 hours after PICU admission till discharge from PICU|All randomized patients analyzed by intention to treat||Mean number of events per 100 study days||95% Confidence Interval|Mean
149128|NCT00395135|Primary|Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52|"The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1.~Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1."|52 weeks|MITT with LOCF||percentage of participants|||Number
149129|NCT00395083|Secondary|Time to All-Cause Death||From randomization until death, assessed up to 26 months|||years||95% Confidence Interval|Median
149130|NCT00395083|Secondary|Hazard Ratio for All-Cause Mortality||26 months|||participants|||Number
149131|NCT00395083|Primary|Hazard Ratio for First COPD Hospitalization||26 months|||participants|||Number
149132|NCT00395083|Primary|Hospitalization-free Survival - Time to Event||From randomization until date of first hospitalization for COPD, assessed up to 26 months|||years||95% Confidence Interval|Median
149133|NCT00395057|Secondary|Time to Treatment With Standard of Care at Month 6|Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.|Month 6|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).||Number of Days||95% Confidence Interval|Median
149134|NCT00395057|Secondary|Visual Functioning Questionnaire (VFQ) at Month 3|Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). Data for this outcome measure were not analyzed as the study was terminated early.|||||
149135|NCT00395057|Secondary|Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3|Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).||Microns||Standard Deviation|Mean
149136|NCT00395057|Secondary|Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3|Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.|Month 3|Intent-To-Treat. The ITT population included all patients who started the study (randomized).||Millimeters squared (mm^2)||Standard Deviation|Mean
149137|NCT00395057|Primary|Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3|Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Month 3|Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).||Percentage of Patients|||Number
149138|NCT00395044|Secondary|Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4|The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning.|Week 0 and Week 4|Cognitive testing was done in a subset of participants enrolled in the study, beginning with randomized subject #21 and continuing until the 50th subject was randomized. The number analyzed is the total number available for analysis that completed both the Baseline and Week 4 assessment.||scores on a scale||Standard Deviation|Mean
149139|NCT00395044|Secondary|Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12|The MPS is an instrument to assess the incidence of physical, psychological, social, and functioning problems that can result from cannabis dependence. The Total score ranges from 0-38 where 0=best outcome and 38=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
149140|NCT00395044|Secondary|Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12|The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
149141|NCT00395044|Secondary|Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12|The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
149142|NCT00395044|Secondary|Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12|The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
149143|NCT00395044|Secondary|Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12|The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score).|Week 0 and Week 12|||units on a scale||Standard Deviation|Mean
149190|NCT00394901|Primary|Mean Pain Scores at Week 13|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 13|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149144|NCT00395044|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use.|Week 0 and Week 12|||ng/ml||Standard Deviation|Mean
149145|NCT00395018|Primary|Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At baseline (day 1), week 12, 24, 36, 48, 60, and 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Non-Completer = Missing (NC = M) approach was used where participants who discontinued early or were missing the measurement were excluded from the specific analysis.||participants||95% Confidence Interval|Number
149146|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)|Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:>1.25xULN;AST:>1.25xULN;ALP:>1.25xULN;Total Bilirubin:>1.1xULN;Serum Lipase:>1.10xULN;Creatinine:>1.1xULN;Blood Urea Nitrogen:>1.25xULN;Hyperglycemia:>116mg/dL;Hypoglycemia:<64mg/dL;Hyponatremia:<132meq/L;Hypernatremia:>148meq/L;Hypokalemia:<3.4meq/L;hyperkalemia:>5.6meq/L;Hypochloremia:<93meq/L;Hyperchloremia:>113meq/L;Albumin: Decrease >= 1g/dL from baseline and < 3 g/dL. HYPER=value>ULN(upper limit of normal). HYPO=value<LLN (lower limit of normal).|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.||participants|||Number
149147|NCT00395018|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)|Criteria for hematology abnormalities were: Hemoglobin : <11.0 g/dL; White Blood Cells : <4000/mm^3; Neutrophils : <1500/mm^3; Platelets : < 99,000/mm^3; International Normalized Ratio (INR) : increase >= 0.5 from baseline.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: All subjects who received atleast 1 dose of study drug.||participants|||Number
149148|NCT00395018|Secondary|Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up.|OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up|Treated population: Participants who received atleast 1 dose of study drug.||participants|||Number
149149|NCT00395018|Secondary|Number of Participants With Re-transplantation Through Week 72||Through week 72|Treated population: Participants who received atleast 1 dose of study drug.||participants|||Number
149150|NCT00395018|Secondary|Number of Participants With Liver Rejection Through Week 72||Through week 72|Treated participants: Participants who received atleast 1 dose of study drug.||participants|||Number
149151|NCT00395018|Secondary|Prothrombin Time (PT) at Week 72|Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: > 1.01 x ULN.|At week 72|Treated participants with measures available at week 72.||seconds||Standard Error|Mean
149152|NCT00395018|Secondary|Total Bilirubin at Week 72|Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : => 1.1 x ULN mg/dL.|At week 72|Treated participants with measures available at week 72.||mg/dL||Standard Error|Mean
149153|NCT00395018|Secondary|Percentage of Participants With HBsAg Recurrence At Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
149154|NCT00395018|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
149155|NCT00395018|Secondary|Percentage of Participants With HBsAg Loss at Week 72|HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|At week 72|Evaluable participants: Treated participants who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
149156|NCT00395018|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|At week 72|HBeAg-positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
149191|NCT00394901|Primary|Mean Pain Scores at Week 12|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 12|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149157|NCT00395018|Secondary|Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week.|At week 72|HBeAg positive participants at baseline who received at least 1 month of ETV therapy. LOCF approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
149158|NCT00395018|Secondary|Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up|HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL.|At 72 weeks + 24 weeks follow-up|This analysis was planned if > 10% of treated participants had HBV DNA measurements during the off-treatment follow-up period.||percentage of participants|||Number
149159|NCT00395018|Secondary|Distribution of ALT Levels Through 72 Weeks: Overall|ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = >1.25 x ULN (upper limit of normal).|On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72|Evaluable population: Treated participants who received at least 1 month of ETV therapy.||U/L||Standard Error|Mean
149160|NCT00395018|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72|HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA => 50 IU/mL = approximately => 300 copies/mL.|At 72 weeks|Evaluable population: Treated participants who received at least 1 month of ETV therapy. Last observation carried forward (LOCF) approach was used for participants with no measurement in the specified visit window.||percentage of participants||95% Confidence Interval|Number
149161|NCT00394953|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.|From screening to Week 56|The Safety Population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Among the 14 deaths in Darbepoetin alfa group, 3 participants died after withdrawal from the study and within 30 days after last dose of study drug.||Participants|||Number
149162|NCT00394953|Secondary|Mean Pulse Rate Over Time|Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|The Safety population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.||beats per minute||Standard Deviation|Mean
149163|NCT00394953|Secondary|Median Blood Pressure Over Time|Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.|Baseline (Week -4 to Week -1), Week 28, and Week 52|Safety Population included all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.||millimeter of mercury||Full Range|Median
149164|NCT00394953|Secondary|Number of Participants With Marked Laboratory Abnormality Over Time|Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.||participants|||Number
149165|NCT00394953|Secondary|Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time|All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.|Week 27 to Month 12|ITT population included all randomized participants. Data is presented for the participants available at the time of assessment.||percent change||Standard Deviation|Mean
149166|NCT00394953|Primary|Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period|Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb >= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.|Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)|ITT population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
149192|NCT00394901|Primary|Mean Pain Scores at Week 11|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 11|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149167|NCT00394914|Secondary|LS Mean Change From Baseline in Asthma-Related Sleep Interference|Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some sleep follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
149168|NCT00394914|Secondary|LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage|SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some SABA follow-up information.||number of puffs of SABA||Standard Deviation|Least Squares Mean
149169|NCT00394914|Secondary|LS Mean Change From Baseline in Total Asthma Symptom Score|Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some asthma symptom score follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
149170|NCT00394914|Secondary|LS Mean Change From Baseline in Total Cold Symptom Score|Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some cold symptom score follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
149171|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.||L/min||Standard Deviation|Least Squares Mean
149172|NCT00394914|Secondary|LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM|PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.||L/min||Standard Deviation|Least Squares Mean
149173|NCT00394914|Secondary|LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some FEV1 follow-up information.||liters||Standard Deviation|Least Squares Mean
149174|NCT00394914|Secondary|LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)|The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.|Baseline through the Final Visit (Day 21)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some ACQ follow-up information.||units on a scale||Standard Deviation|Least Squares Mean
149193|NCT00394901|Primary|Mean Pain Scores at Week 10|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 10|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149194|NCT00394901|Primary|Mean Pain Scores at Week 9|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 9|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149175|NCT00394914|Primary|Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR|"Asthma exacerbation was defined as a participant having one of the following:~0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ.~Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization.~PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization."|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine exacerbation.||percentage of participants|||Number
149176|NCT00394914|Primary|Percentage of Participants With Rhinovirus PCR-Positive Colds|The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.|From time of exposure to index case to end of Follow-up Period (21 days)|Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine rhinovirus cold.||percentage of participants|||Number
149177|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 13|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 13|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149178|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 12|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 12|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149179|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 11|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 11|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149180|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 10|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 10|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149181|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 9|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 9|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149182|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 8|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 8|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149183|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 7|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 7|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149184|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 6|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 6|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149185|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 5|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 5|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149186|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 4|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 4|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149187|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 3|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 3|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149188|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 2|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 2|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149189|NCT00394901|Secondary|Mean Sleep Interference Scores at Week 1|Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.|week 1|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149198|NCT00394901|Primary|Mean Pain Scores at Week 5|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 5|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149199|NCT00394901|Primary|Mean Pain Scores at Week 4|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week4|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149200|NCT00394901|Secondary|Number of Patients Not Reporting Hyperalgesia|Participants not reporting hyperalgesia.|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
149201|NCT00394901|Secondary|Number of Patients Not Reporting Allodynia|Participants not reporting allodynia.|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
149202|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Mental Health|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149203|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Vitality|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149204|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149205|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149206|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149207|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149208|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149209|NCT00394901|Secondary|Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning|Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149210|NCT00394901|Secondary|Endpoint Clinical Global Impression Change|Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
149211|NCT00394901|Secondary|Endpoint Patient Global Impression Change|Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Deviation|Mean
149212|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep|Number of participants who reported Optimal Sleep|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
149213|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index|Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149214|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence|Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149215|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy|Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149216|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep|Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149217|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache|Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149218|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring|Score range for snoring is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149219|NCT00394901|Secondary|Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance|Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149220|NCT00394901|Secondary|Mean Sleep Interference Scores at Endpoint|Scores range from 0-10. Higher scores indicate more severe interference with sleep.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149221|NCT00394901|Secondary|Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire|Present pain intensity score range from 0-5. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149222|NCT00394901|Secondary|Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire|Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||mm||Standard Error|Least Squares Mean
149223|NCT00394901|Secondary|Endpoint Total Scores of the Short-Form McGill Pain Questionnaire|Total score range from 0-45. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward||score on scale||Standard Error|Least Squares Mean
149224|NCT00394901|Secondary|Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire|Affective score range from 0-12. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149225|NCT00394901|Secondary|Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire|Sensory score range from 0-33. Higher scores indicate more severe pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149226|NCT00394901|Primary|Mean Pain Scores at Week 3|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 3|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149227|NCT00394901|Primary|Mean Pain Scores at Week 2|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 2|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149228|NCT00394901|Primary|Mean Pain Scores at Week 1|Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.|Week 1|Full analysis set. Observed case.||score on scale||Standard Error|Least Squares Mean
149229|NCT00394901|Primary|Number of Responders|A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.|Week13/discontinuation|Full analysis set. Last observation carried forward.||participants|||Number
149230|NCT00394901|Primary|Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149231|NCT00394901|Primary|Mean Pain Scores at Endpoint|Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.|Week13/discontinuation|Full analysis set. Last observation carried forward.||score on scale||Standard Error|Least Squares Mean
149232|NCT00394888|Primary|Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound|The number of participants with multiple (greater than or equal to 5) cutaneous infantile hemangiomas who were found to have hepatic hemangiomas via the us abdominal ultrasound.|2 years|Subjects enrolled in the hepatic hemangioma arm (n= 151) were analyzed for this outcome measure.||Participants|||Number
149233|NCT00394888|Primary|Cardiac Abnormalities Detected Via Clinical Examination|The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.||Participants|||Number
149234|NCT00394888|Primary|Cerebrovascular and Structural Brain Abnormalities|The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.|2 years|Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.||Participants|||Number
149235|NCT00394888|Primary|Spinal Abnormalities|The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.|2 years|Subjects enrolled in the lumbrosacral hemangioma arm (n= 48) were analyzed for this outcome measure||Participants|||Number
149236|NCT00394888|Primary|Clinical Diagnosis of PHACE Syndrome|For subjects in the large facial hemangioma arm of the study, a clinical assessment by trained physicians was conducted to determine whether or not each subject met diagnostic criteria for PHACE syndrome.|2 years|Subjects enrolled in the large facial hemangioma arm (n= 108) were analyzed for this outcome measure.||Participants|||Number
149237|NCT00394888|Primary|MRI/MRA of Head/Neck/Chest.||2 years|||participants|||Number
149238|NCT00394836|Secondary|Vss After the Eighth Infusion (Visit 9, Week 7)|Vss is the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7; to up 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data of 28 April 2009.||mL||Geometric Coefficient of Variation|Geometric Mean
149239|NCT00394836|Secondary|CL After the Eighth Infusion (Visit 9, Week 7)|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
149240|NCT00394836|Secondary|t1/2 After the Eighth Infusion (Visit 9, Week 7)|t1/2 is defined as terminal half-life, which is the time required for the amount of the drug in the body to decrease by half.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||hours||Geometric Coefficient of Variation|Geometric Mean
149241|NCT00394836|Secondary|AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||Milligrams * hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
149242|NCT00394836|Secondary|Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7)|Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before the start of the next infusion]).|Visit 9 (Week 7; up to 10 months after dose)|FAS. Data were provided for the number of participants who had a value. Cmax was not reported for one participant due to missing data. Participants withdrawn during the study were not analyzed. Interim results; data as of 28 April 2009.||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
149243|NCT00394836|Secondary|Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.)|FcR poly. affect the affinity with which FcRs interact with immunoglobulin molecules and are prognostic factors that are indicative of altered responsiveness to treatment and/or survival. A blood sample was drawn at Visit 1 for analysis (done in batches of several samples) of FcR poly. (Fcgamma RIIIa Valine/Phenylalanine genotypes [TT=thymidine/thymidine, TG=thymidine/guanine, GG=guanine/guanine] and Fcgamma RIIa Arginine/Histidine genotypes [AA=adenine/adenine, AG=adenine/guanine, GG=guanine/guanine]). Responders must have met the criteria for CR, CRu, or PR at either Month 3 or Month 6. Fc receptor polymorphisms and C1qA-276 results are not included in this results summary.|From first treatment (Visit 2) until Visit 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||participants|||Number
149244|NCT00394836|Secondary|Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2|Blood samples were drawn from participants at Visits 1 and 2 for analysis of complement (CH50) levels. Analysis of CH50 was done in batches, and CH50 levels were measured two hours after the end of study medication infusion. Percent change from Screening (Visit 1, Week -2) = (value at Visit 2 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2) and 2 (Week 0)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Units per milliliter (U/mL)||Full Range|Median
149245|NCT00394836|Secondary|Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14|HAHA are indicators of immunogenicity to ofatumumab. Blood samples were withdrawn from participants at Visits 1, 12, 13, and 18 for analysis of HAHA. Analysis of HAHA was done in batches.|Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||participants|||Number
149246|NCT00394836|Secondary|Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A list of AEs experienced in the study at a frequency threshold of 5% can be found in the AE section.|From first treatment (Visit 2) until Visit 18 (Month 24)|FAS||participants|||Number
149247|NCT00394836|Secondary|Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood|"B-cell lymphoma 2 (BCL2) is the second member of a range of proteins initially described in chromosomal translocations involving chromosomes 14 and 18 in follicular lymphomas. BCL2 mitochondrial ribonucleic acid (mRNA) was measured by polymerase chain reaction (PCR) from peripheral blood. Participants who had no post-screening data were categorized as Missing."|Screening (Visit 1) until Month 24 (Visit 18)|FAS. Only those participants who were BCL2 positive at Screening were analyzed.||participants|||Number
149248|NCT00394836|Secondary|Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12|CD19 and CD20 are proteins found on the cell surface of B cells, and they can be detected in peripheral blood by flow cytometry. Flow cytometry of peripheral blood was performed for immediate analysis of cells with cluster of differentiation 19 (CD19+) and CD20+. The analysis will be done until a value is reached that is in the normal range. Percent change from Baseline (Visit 2) = (value at Visits 11 and 12 minus the value at Visit 2 divided by the value at Visit 2) * 100.|Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in cells||95% Confidence Interval|Median
149249|NCT00394836|Secondary|Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24|Tumor size was measured by computed tomography (CT) scan and was computed as the sum of product of diameters (SPD) for the indicator lesions. CT scans with contrast of the neck, thorax, abdomen, and pelvis were performed at Screening and during the follow-up period (Month 3, 6, 9, 12, 18, and 24). The change in tumor size from Screening (Visit 1) was presented per Radiologist 1 (R1) and Radiologist 2 (R2). Percent change from Screening (Visit 1, Week -2) = (value at Visits 11, 12, 13, 14, 16, and 18 minus the value at Visit 1 divided by the value at Visit 1) * 100.|Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||percent change in tumor size||Full Range|Median
149250|NCT00394836|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. For participants who are lost to follow-up, overall survival will be censored at the date of the last attended visit at which the endpoint was assessed.|First dose (Week 0) until 5 years|FAS. As of the time of data cut-off, data for Overall Survival was not estimable because too few deaths have occurred at the time of study completion.||Months||95% Confidence Interval|Median
149251|NCT00394836|Secondary|Time to Next Follicular Lymphoma (FL) Therapy|Time to next FL (anti-lymphoma) therapy is defined as the time from randomization until the time of first administration of the next anti-lymphoma therapy other than ofatumumab. For participants who were lost to follow-up, the time was censored at the date of the last attended visit at which the endpoint was assessed.|From start of treatment (Week 0) until Month 24|FAS||Months||95% Confidence Interval|Median
149252|NCT00394836|Secondary|Progression-Free Survival|Progression-free survival (PFS) is defined as the time from randomization until the first radiologically or clinically documented evidence of progression or death due to any cause, if sooner. For participants who were lost to follow-up, PFS was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate PFS.|From start of treatment (Week 0) until Month 24|FAS||Months||95% Confidence Interval|Median
149253|NCT00394836|Secondary|Duration of Response|The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death. For participants who were lost to follow-up, duration of response was censored at the date of the last attended visit at which the endpoint was assessed. The Kaplan-Meier method was used to estimate duration of response.|From start of treatment (Week 0) until Month 24|FAS. Only those participants classified as responders were analyzed.||months||95% Confidence Interval|Median
149254|NCT00394836|Primary|Number of Participants Classified as Responders and Non-responders for Objective Response (OR)|Based on OR over a 6-month period from start of treatment, participants were classified as responders/non-responders as follows: participants with CR, CRu, or PR were classified as responders, whereas participants with Stable Disease (SD; achieving less than PR but not consistent with PD), Progressive Disease (PD; 50% increase from nadir in the products of the greatest perpendicular diameters of any previously identified node or appearance of any new node >1 cm), or Not Evaluable (NE) participants were classified as non-responders.|6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).|FAS||participants|||Number
149255|NCT00394836|Primary|Number of Participants With Objective Response (OR)|OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass >1.5 centimeters [cm] in its longest transverse diameter that regressed >75% compared to baseline), or Partial Response (PR; >=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.|Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)|Full Analysis Set (FAS): all participants who were exposed to study drug irrespective of their compliance to the planned course of treatment||participants|||Number
149256|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||days||Full Range|Median
149257|NCT00394771|Other Pre-specified|Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||days||Full Range|Median
149258|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||participants|||Number
149259|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||participants|||Number
149260|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||participants|||Number
149261|NCT00394771|Secondary|Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)|Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||participants|||Number
149262|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.|Day 177-183|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||participants|||Number
149263|NCT00394771|Secondary|Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)|Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.|Day 85-91|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||participants|||Number
149264|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||days||Full Range|Median
149265|NCT00394771|Secondary|Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)|"Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.~Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.~See pre-specified analyses for Number of Moderate to Heavy Bleeding Days."|Day 1-84|ITT population. However data was not summarized due to limitations in the diary data.|||||
149266|NCT00394771|Secondary|Time to First Bleeding Day|"Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.~Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding."|Day 1-84|ITT population. However this data was not summarized due to limitations in the diary data.|||||
149267|NCT00394771|Secondary|Days With Bleeding During Active Cycle 2 (Day 92-176)|Bleeding is defined as a flow heavy enough to require sanitary protection.|Day 92-176|Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.||days||Full Range|Median
149269|NCT00394771|Primary|Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)|Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.|Day 1-84|Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.||days||Full Range|Median
149270|NCT00394706|Secondary|Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months||6 months post hospital discharge||||||
149271|NCT00394706|Secondary|Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months||6 months post hospital discharge||||||
149272|NCT00394706|Secondary|Modified Rankin Score at 6 Months After Hospital Discharge|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).|6 months post hospital discharge||||||
149273|NCT00394706|Secondary|Survival to Hospital Discharge||Survival to hospital discharge or death before discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.||participants|||Number
149274|NCT00394706|Primary|Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).|The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.|Hospital discharge or death prior to discharge|Analyses of both interventions excluded subjects who suffered arrest secondary to drowning, strangulation, or electrocution; or for whom the primary outcome was unknown. Additionally, the ITD vs. Sham analysis excluded subjects who did not have the device applied, had study exclusions, or who had a response time of more than 15 minutes.||participants|||Number
149275|NCT00394654|Secondary|Terminal Phase Volume of Distribution (Vz)|Vz of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Liter||Geometric Coefficient of Variation|Geometric Mean
149276|NCT00394654|Secondary|Total Body Clearance (CL)|CL of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Liter per day||Geometric Coefficient of Variation|Geometric Mean
149277|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained||Day||Geometric Coefficient of Variation|Geometric Mean
149278|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained||Day||Geometric Coefficient of Variation|Geometric Mean
149279|NCT00394654|Secondary|Terminal Phase Half-Life (T1/2)|T1/2 of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Day||Geometric Coefficient of Variation|Geometric Mean
149280|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained||Percent||Geometric Coefficient of Variation|Geometric Mean
149281|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained||Percent||Geometric Coefficient of Variation|Geometric Mean
149282|NCT00394654|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Percent||Geometric Coefficient of Variation|Geometric Mean
149283|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
149284|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized, received any MEDI-528, and had sputum samples obtained||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
149285|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
149286|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
149287|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528||Nanogram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
149288|NCT00394654|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Microgram times day per milliliter||Geometric Coefficient of Variation|Geometric Mean
149289|NCT00394654|Secondary|Observed Maximum Nasal Lavage Concentration (Cmax)|Cmax of MEDI-528 in nasal lavage|Days -6 to -1, 8, 29, and 57|All participants who were randomized and received any MEDI-528||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
149290|NCT00394654|Secondary|Observed Maximum Sputum Concentration (Cmax)|Cmax of MEDI-528 in sputum|Days -21 to -7, 7, 28, and 56|All participants who were randomized and received any MEDI-528||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
149291|NCT00394654|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528 in serum|Days 0, 6, 7, 27, 55, 84, and 126|All participants who were randomized and received any MEDI-528||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
149298|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
149299|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
149300|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
149301|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 56|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
149302|NCT00394654|Primary|Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28|Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 28|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
149303|NCT00394654|Primary|Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7|Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.|Day 7|All participants who were randomized into the study and completed the second allergen challenge on Day 7.||Percent||Standard Deviation|Mean
149304|NCT00394589|Primary|Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.|Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).|Between Screening (Week <=1) and Week 24|Intent-to-treat population; subjects with available data at both Baseline and Week 24||Score on a Scale||Standard Deviation|Mean
149305|NCT00394524|Secondary|Mean Hospital Length of Stay in Days|mean number of days in the hospital|during the entire hospitalization|||days||Standard Deviation|Mean
149306|NCT00394524|Secondary|Length of Intensive Care Unit (ICU) Stay|average number of days in the intensive care unit|mean number of days in the ICU during the hospital stay|||days||Standard Deviation|Mean
149307|NCT00394524|Secondary|Differences Between Treatment Groups in Hypoglycemia||daily||||||
149308|NCT00394524|Primary|Mean Glucose|glucose in mg/dl assessed with inpatient calibrated glucometers|daily mean blood glucose during the insulin infusion|||mg/dl||Standard Deviation|Mean
149309|NCT00394472|Secondary|Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule||An interval of one to two hours after the first intake of AZD3355 65 mg capsule|||μmol/L||Standard Deviation|Mean
149310|NCT00394472|Primary|Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms ‘a Burning Feeling Behind the Breastbone’ and ‘Unpleasant Movement of Material Upwards From the Stomach’ During the Last Seven Days of Treatment|Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary|Twice daily during the last seven days on treatment|||Participants|||Number
149311|NCT00394433|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all enrolled patients.||months||95% Confidence Interval|Median
149312|NCT00394433|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.|Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).|The analysis dataset is comprised of all enrolled patients.||months||95% Confidence Interval|Median
149313|NCT00394433|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).|The analysis dataset is comprised of all treated and evaluable patients.||participants|||Number
149852|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness Leading to Death|Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.|From baseline to Week 144|FAS||Patients|||Number
149314|NCT00394433|Primary|10-month Progression-Free Survival Rate|10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions or Equivocal progression of non-target lesions also qualifies as PD.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.|The analysis dataset is comprised of all enrolled patients.||probability||95% Confidence Interval|Number
149315|NCT00394355|Secondary|Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).|Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward)|Baseline and up to ~ one year of treatment|||percentage of FEV1||Standard Deviation|Mean
149316|NCT00394355|Secondary|Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants||percentage of BMD||Standard Deviation|Mean
149317|NCT00394355|Secondary|Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants||percentage of BMD||Standard Deviation|Mean
149318|NCT00394355|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point|The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward.|Baseline and up to ~ one year of treatment|All randomized participants||percentage of BMD||Standard Deviation|Mean
149319|NCT00394329|Secondary|Adverse Events||Measured during the 44-week treatment period||||||
149320|NCT00394329|Secondary|Asthma Control Test||Measured during the 44-week treatment period||||||
149321|NCT00394329|Secondary|Asthma-specific Quality of Life Assessment||Measured during the 44-week treatment period||||||
149322|NCT00394329|Secondary|Exhaled Nitric Oxide||Measured during the 44-week treatment period||||||
149323|NCT00394329|Secondary|Methacholine Provocative Concentration at 20% (PC20)||Measured during the 44-week treatment period||||||
149324|NCT00394329|Secondary|Impulse Oscillometry||Measured during the 44-week treatment period||||||
149325|NCT00394329|Secondary|Peak Expiratory Flow Rate Variability||Measured during the 44-week treatment period||||||
149326|NCT00394329|Secondary|Morning (AM) and Evening (PM) Peak Expiratory Flow Rate||Measured during the 44-week treatment period||||||
149327|NCT00394329|Secondary|Spirometry, Pre- and Post-bronchodilator||Measured during the 44-week treatment period||||||
149328|NCT00394329|Secondary|Albuterol Use||Measured during the 44-week treatment period||||||
149329|NCT00394329|Secondary|Asthma Control Days||Measured during the 44-week treatment period||||||
149330|NCT00394329|Primary|Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy||Measured during the 44-week treatment period|All randomized participants were included in the time-to-event analysis||participants||95% Confidence Interval|Number
149331|NCT00394277|Secondary|SVR-12 (Actual Treatment Period)|SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
149332|NCT00394277|Secondary|SVR-12 (Scheduled Treatment Period)|SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).|12 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
149333|NCT00394277|Secondary|SVR-24 (Actual Treatment Period)|SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.|24 weeks after end of treatment|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
149334|NCT00394277|Primary|Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)|SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).|Week 72|Intent-to-treat population (all patients treated with at least one dose of either study medication)||Percentage of patients|||Number
149350|NCT00394095|Primary|Change in Body Mass Index (BMI)|For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.|12 weeks|The analysis was per protocol based on change in BMI over 12 weeks in the Experimental sample (N=16) compared to the Placebo group (N=14).||kg/m2||95% Confidence Interval|Mean
149351|NCT00394082|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to patient death from any cause. Patients that did not die were censored at the last known time the patient was alive.|up to 39 months|Treated population||months||95% Confidence Interval|Median
149375|NCT00393861|Primary|Twelve Month Disease-free Survival Rate|The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.|12 month post completion of treatment|All patients enrolled and received treatment.||percentage of participants||90% Confidence Interval|Number
149335|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 6 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 6 months after chemotherapy (month 10).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 6 months after chemotherapy (month 10)."|Month 10|Participants in the Treated Population for whom safety data was available 6 months post-chemotherapy||participants|||Number
149336|NCT00394251|Secondary|Summary of Participants’ Most Severe Grade for Liver and Renal Function Laboratory Adverse Experiences During Study (All Treatment Cycles)|"Summary of the most severe grades using the National Cancer Institute’s Common Terminology Criteria for Adverse Events v3.0 (CTCAE) for the following liver and renal function tests.~Grade 0 = within normal range for all measurements.~Alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST):~Grade 1 = > upper limit of normal (ULN) – 2.5*ULN~Grade 2= >2.5-5.0*ULN~Grade 3= >5.0-20.0*ULN~Grade 4= >20.0*ULN~Bilirubin:~Grade 1= >ULN – 1.5*ULN~Grade 3= >3.0 – 10.0*ULN~Creatinine:~- Grade 1= >ULN – 1.5*ULN"|Week 1 up to week 50|Treated population with at least one post-treatment laboratory measure.||participants|||Number
149337|NCT00394251|Secondary|Change From Baseline in Percent Left Ventricular Ejection Fraction (% LVEF) at the Final Evaluation|Decreased left ventricular ejection fraction (LVEF) is an indication of cardiotoxicity. Change from baseline measurements to the final evaluation are summarized.|up to week 46|Participants in the treated population who had both baseline and one treatment measurement for %LVEF||percentage of healthy LVEF||Full Range|Median
149338|NCT00394251|Secondary|Myelosuppression During Taxane Dosing Cycles|"Myelosuppression represented by neutropenia (low absolute neutrophil counts (ANC)) with severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).~Grade 1 = <lower limit of normal (LLN)-1.5*10^9/L~Grade 2 = <1.5 - 1.0*10^9/L~Grade 3 = <1.0 - 0.5*10^9/L~Grade 4 = <0.5*10^9/L~Values are reported across all severity grades without assessment of relationship to taxane treatment, and also by relation to taxane treatment as reported by investigators."|Weeks 9-16|Participants in the treated population who received at least 1 dose of taxane and had laboratory values.||participants|||Number
149339|NCT00394251|Secondary|Summary of Participant Treatment Exposure, Dose Interruptions, Dose Reductions, and Dose Delays|"Counts of participants who~completed the protocol-defined treatment cycles,~had a dose interruption~had a dose reduction~had a dose delay. A dose delay refers to the delay of all interventions in the cycle.~Dose modifications are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.~Use of pegfilgrastim is included in the summary."|up to Week 46|Treated population||participants|||Number
149340|NCT00394251|Secondary|Percent of Protocol Taxane Dose|Percent of the protocol-defined taxane (ABI-007 or Taxol) dose that was actually taken by study participants.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.||percentage of protocol-defined taxane||Standard Deviation|Mean
149341|NCT00394251|Primary|Participants With Treatment-Emergent Toxicities With a Frequency >=20% at 3 Months Post Chemotherapy|"Toxicities are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) terms. Participants with treatment-emergent toxicities with a frequency of >=20% in any treatment arm, and participants with at least one toxicity are reported.~Taxane subsets (ABI-007 subset and Taxol subset treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of taxane treatment (cycle 5, week 9) through 30 days after the last dose of taxane (week 20) and were ongoing 3 months after chemotherapy (month 7).~Entire regiments (AC --> ABI-007 and AC --> Taxol treatment arms) summarize participants with treatment-emergent toxicities defined as any AEs that begin or worsen in severity grade after the start of chemotherapy (cycle 1, week 1) through 30 days after the last dose of chemotherapy (week 20) and were ongoing 3 months after chemotherapy (month 7)."|Month 7|Participants in the Treated Population for whom safety data was available 3 months post-chemotherapy||participants|||Number
149342|NCT00394251|Secondary|Mean Taxane Dose Intensity Per Week|Cumulative taxane (ABI-007 or Taxol) dose divided by the number of weeks on taxane treatment.|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.||mg/m^2/week||Standard Deviation|Mean
149343|NCT00394251|Secondary|The Cumulative Dose of Taxane Delivered During Study|The cumulative dose of taxane (Taxol or ABI-007) taken during the study (cycles 4-8 which is approximately weeks 9-16).|approximately week 9-16|Participants in the treated population who received at least 1 dose of taxane.||mg/m^2||Standard Deviation|Mean
149344|NCT00394212|Secondary|Subjects Achieving 20% Excess Weight Loss at 6 Months|%Excess Weight Loss (%EWL) is computed as: [(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100|6 months|ITT, Last Observation Carried Forward||percentage of participants|||Number
149345|NCT00394212|Secondary|Subjects Achieving Weight Stabilization at 6 Months|Weight is stabilized if 6 month weight is +/- 2% from baseline weight.|6 months|ITT, Last Observation Carried Forward||percentage of participants|||Number
149346|NCT00394212|Secondary|Subjects Achieving 15% Excess Weight Loss (EWL)|%Excess Weight Loss (%EWL) is computed as:[(Weight at Baseline - Weight at 6 months)/(Weight at Baseline - Ideal Weight at BMI of 25)]*100.|6 months|ITT, Last Observation Carried Forward||percentage of participants|||Number
149347|NCT00394212|Primary|Weight Loss (%)|Percent Weight Loss is computed as [(Baseline weight - 6 mo. weight) / Baseline weight] * 100|6 months|ITT using Last Observation Carried Forward (LOCF)||percentage of weight lost||Standard Deviation|Mean
149348|NCT00394095|Primary|Change in Body Weight|For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.|12 weeks|Bipolar youth (ages 12-17) who were taking olanzapine (10-20 mg/day) for a manic episode, were given topiramate (300-400mg/day) or comparable dose placebo for 12 weeks. Analysis was per protocol.||kg||95% Confidence Interval|Mean
149376|NCT00393848|Secondary|Change in Maximal Voluntary Contraction||Baseline and 6 weeks post surgery|Measure not performed in Experiment 2||kg/kg leg lean mass||Standard Error|Mean
149352|NCT00394082|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease is defined in outcome #2. Complete response (CR) and partial response (PR) are defined in outcome #3."|up to 39 months|Treated population of participants who had a response.||months||95% Confidence Interval|Median
149353|NCT00394082|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). RECIST defines SD as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease and no new lesions. Definitions for CR and PR can be found in outcome #3.|up to 39 months|Treated population||percentage of participants||95% Confidence Interval|Number
149354|NCT00394082|Secondary|Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response is complete response (CR) + partial response (PR). RECIST defines overall response of CR as the disappearance of all target and non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. Overall response of PR is defined as >= 30% decrease from baseline in the sum of the longest diameters of target lesions and no progression of non-target lesions and no appearance of new lesions, confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing and no appearance of new lesions. The objective response is determined by combining the response of target and non-target lesions and the appearance of new lesion(s) or not together.|up to 39 months|Treated population.||percentage of participants||95% Confidence Interval|Number
149355|NCT00394082|Primary|Kaplan-Meier Estimates for Progression-free Survival|"Progression-free survival is defined as the time from first dose of study drug to the start of disease progression or patient death, whichever occurs first. Patients who do not have disease progression or have not died at the end of follow-up were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Response Evaluation Criteria in Solid Tumors (RECIST) defines progressive disease (PD) as a >= 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to 39 months|Treated population.||months||95% Confidence Interval|Median
149356|NCT00394082|Primary|Participants With At Least One Treatment-Emergent Adverse Event (TEAE)|Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug.|up to 25 months|Safety population||participants|||Number
149357|NCT00393939|Secondary|Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score|EQ-5D: standardized, participant-administered 2 part measure of health outcome. Part 1: descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), used 3 levels (no, some, extreme problems) and a single index value characterized current health status using formula that weighted the dimensions. Part 2: overall rating of participant's current health used Visual Analog Scale with endpoints labeled ‘best imaginable health state’ and ‘worst imaginable health state’. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.||units on a scale||95% Confidence Interval|Mean
149358|NCT00393939|Secondary|Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score|EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning, sexual enjoyment, and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.||units on a scale||95% Confidence Interval|Mean
149359|NCT00393939|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score|EORTC QLQ-C30 measured 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. For functional domains and global health status, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. Change from baseline = score for Cycle/Day minus baseline score.|Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)|ITT population; data not analyzed because study failed its primary endpoint.||units on a scale||95% Confidence Interval|Mean
149360|NCT00393939|Secondary|Overall Survival (OS)|Time from randomization to date of death due to any cause. OS calculated as (Months) = (death date minus date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored at last contact.|Baseline to date of death from any cause (up to Month 33)|ITT population||months||95% Confidence Interval|Median
149361|NCT00393939|Secondary|Duration of Response (DR)|DR defined as time from first objective documentation of complete or partial response that was subsequently confirmed to first documentation of disease progression or to death due to any cause, whichever occurred first. DR calculated (Months) = (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.|Baseline up to Month 33|ITT population. Number of participants analyzed = number of participants with confirmed objective tumor response.||months||95% Confidence Interval|Median
149362|NCT00393939|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all tumor lesions (target and non-target). PR defined as greater than or equal to 30 percent (≥30%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions with a non-progressive disease status of the non-target lesions.|Baseline up to Month 33|ITT population||percentage of participants|||Number
149363|NCT00393939|Primary|Progression-Free Survival (PFS)|PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.|Baseline up to Month 33|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
149364|NCT00393913|Primary|Vigilance|Vigilance is measured using the psychomotor vigilance task which is a portable reaction time test that is contained in a small, programmable, portable electronic box that requires only a single switch to start. The task consists of responding to a small bright red light stimulus by pressing a response button as soon as the stimulus appears. This stops the stimulus counter and displays the reaction time (RT) in milliseconds for a 2-second period and the task duration is 20 minutes. The subject is instructed to press the button as soon as each stimulus appears in order to keep the reaction time as low as possible. The PVT yields highly informative metrics on the capacity for sustained attention including the frequency of lapses (reaction time > 500 milliseconds). The higher the number of lapses the greater the impairment. Well rested (non-sleepy) subjects have almost no lapses(<2) during the 20min test.|Baseline, CPAP (4-6 weeks), CPAP withdrawal (2 nights)|Per protocol||Lapses||Standard Deviation|Mean
149365|NCT00393913|Primary|Objective Sleepiness|Multiple Sleep Latency Test (MSLT) measures the latency to sleep onset in minutes. The shorter the latency to sleep the more sleepy the subject.|Measured at baseline, on CPAP (4-6 weeks), CPAP withdrawal (2 nights)|||minutes||Standard Deviation|Mean
149366|NCT00393913|Primary|Subjective Sleepiness|Measured using the Epworth sleepiness scale (ESS). The Epworth sleepiness scale is used in the assessment of daytime sleepiness and measures the general level of sleepiness.The ESS presents the subject with eight situations and asks how likely they are to fall asleep (0= never, 1 =slight chance of dozing, 2= moderate chance of dozing and 3 =high chance of dozing) in these situations. The sum of the 8 answers is used as the score and ranges from 0 (not sleepy) to 24 (extremely sleepy), and a score of greater than 10 is an indication that a person may be excessively sleepy.|Baseline, CPAP( 4 -6 weeks), Off CPAP ( 2 nights)|||units on a scale||Standard Deviation|Mean
149367|NCT00393887|Primary|Number of Patients With Inguinal Hernia Recurrence||1 year|||participants|||Number
149368|NCT00393874|Primary|PSQI|"Self-report sleep quality measure. Scores range between 0 and 21, with higher scores reflecting poor sleep quality.~A score of < or = to 5 reflects good sleep quality."|Baseline, post, 4 months post-treatment|For the medication arm, 18 participants completed PSQI at screening, 14 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.||units on a scale||Standard Deviation|Mean
149369|NCT00393874|Primary|PSG Composite Measure|"Sleep Efficiency (SE) is the ratio of total time spent asleep over total time spent in bed.~For PSG studies, (SE) typically vary between 50% and 95%. Greater values indicated more consolidated sleep."|Baseline sleep study and post sleep study|For the medication arm, 18 participants completed a PSG study at baseline and 13 completed a PSG post treatment. For the Behavioral arm, 17 participants completed a PSG at baseline and 12 completed a PSG post-treatment. For the placebo arm, 15 participants completed a PSG at baseline and 12 completed a PSG post-treatment.||percentage of time asleep vs time in bed||Standard Deviation|Mean
149370|NCT00393874|Primary|Sleep Diary Measures|"Sleep diary SE, nightmare frequency Sleep diary sleep efficiency can range from 0 to 100%, and typically varies between 50% and 95%. Higher % values reflect greater sleep consolidation, i.e., greater ratio of time asleep/time in bed.~Nightmare frequency varies between 0 and no upper limit is provided. Greater frequency of nightmares reflects greater nightmare severity."|baseline and post|For the medication arm, 15 participants completed the sleep diary (SD) at baseline and 13 returned a SD post treatment. For the Behavioral arm, 15 participants completed the SD at baseline, and 12 returned it at follow-up. For the placebo arm, 12 participants completed the diary at baseline and 10 returned one at follow-up.||units on a scale||Standard Deviation|Mean
149371|NCT00393874|Primary|Insomnia Severity Index|Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score < 8 is considered to reflect no significant insomnia.|Screening, Post, and Follow-up|For the medication arm, 18 participants completed ISI at screening, 15 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.||units on a scale||Standard Deviation|Mean
149372|NCT00393861|Secondary|Overall Survival|Will be examined using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
149373|NCT00393861|Secondary|Duration of Remission (CR + PR)|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|completion of study, up to 5 years|All patients enrolled and received treatment.||months||95% Confidence Interval|Median
149374|NCT00393861|Secondary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|completion of study, up to 5 years|All patients enrolled and received treatment.||percentage of participants||90% Confidence Interval|Number
149377|NCT00393848|Primary|Muscle Protein Synthesis||Perioperative and discharge|||%/d||Standard Error|Mean
149378|NCT00393796|Primary|Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo|"The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.~Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 Months Post Treatment|||percentage of participants||95% Confidence Interval|Number
149379|NCT00393718|Secondary|Hypoglycaemic Episodes|Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|over 52 weeks of treatment|Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.||number of events per year of exposure|||Number
149380|NCT00393718|Secondary|Body Weight After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
149381|NCT00393718|Secondary|Body Weight After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||kg||Standard Error|Least Squares Mean
149382|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
149383|NCT00393718|Secondary|Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
149384|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment|Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
149385|NCT00393718|Secondary|Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment|Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
149386|NCT00393718|Secondary|Postprandial Glucose AUC After 52 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment|after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
149387|NCT00393718|Secondary|Postprandial Glucose AUC After 24 Weeks of Treatment|Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment|after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL *h||Standard Error|Least Squares Mean
149388|NCT00393718|Secondary|Fasting Plasma Glucose After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
149389|NCT00393718|Secondary|Fasting Plasma Glucose After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||mg/dL||Standard Error|Least Squares Mean
149390|NCT00393718|Secondary|Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment||after 52 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
149391|NCT00393718|Primary|Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment||after 24 weeks of treatment|Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.||percentage of total haemoglobin||Standard Error|Least Squares Mean
149394|NCT00393705|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.||number of events per 30 days||Standard Deviation|Mean
149395|NCT00393705|Secondary|Number of Patients With Self-reported Hypoglycemic Episodes|Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.|Baseline through 16 weeks|Number of patients who received at least one dose of study drug and had at least one assessment after randomization.||participants|||Number
149396|NCT00393705|Secondary|Mean Daily Blood Glucose Values at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline blood glucose reading at week 16 for the respective variable.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
149397|NCT00393705|Secondary|Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial blood glucose reading after the midday meal at week 16.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
149398|NCT00393705|Secondary|2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint|Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16.|16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial plasma glucose reading after the midday meal at week 16.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
149399|NCT00393705|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint||Baseline, 16 Weeks|Number of patients who received at least one dose of study drug and a post-baseline HbA1c value at endpoint.||percent HbA1c||Standard Deviation|Mean
149400|NCT00393705|Secondary|Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had a post-baseline HbA1c value at endpoint.||percentage of participants|||Number
149401|NCT00393705|Primary|Hemoglobin A1c (HbA1c) at 16 Week Endpoint||16 weeks|Number of patients who received at least one dose of study drug and had an HbA1c measure at endpoint.||percent HbA1c||Standard Deviation|Mean
149402|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
149403|NCT00393523|Other Pre-specified|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
149404|NCT00393523|Secondary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy|Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||Participants|||Number
149405|NCT00393523|Primary|Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy|Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.|4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B|Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.||Participants|||Number
149409|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until Week 96|Randomized participants who received at least 1 dose of study drug and who were evaluable.||Participants|||Number
149410|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Start of dosing (Day 1) until end of treatment (Week 240) + 5 days|Participants who were randomized and received at least 1 dose of study drug||Participants|||Number
149411|NCT00393484|Secondary|Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96|Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement).|At 96 weeks|All participants who received study drug and who had samples of measureable HBV DNA values||Participants|||Number
149412|NCT00393484|Secondary|Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240|Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay|At Weeks 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug||Percetage of participants|||Number
149413|NCT00393484|Secondary|Number of Participants With Virologic Rebound at Week 24|Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement).|At Week 24|||Participants|||Number
149414|NCT00393484|Secondary|Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24|Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug||Participants|||Number
149415|NCT00393484|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24|ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period|Randomized participants who received at least 1 dose of study drug||Participants|||Number
149416|NCT00393484|Secondary|Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24|ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period|Randomized participants who received at least 1 dose of study drug||Participants|||Number
149417|NCT00393484|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status.|Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period|Treated cohort: includes participants who are randomized and received at least 1 dose of study drug (ETV or LVD).||Participants|||Number
149418|NCT00393484|Secondary|Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96|Normalization of serum ALT= ≤*institutional upper limit of normal.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug||Participants|||Number
149419|NCT00393484|Secondary|Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24|Mean ALT values from baseline by laboratory test. .|At Week 24|Randomized participants who received at least 1 dose of study drug||U/L||Standard Deviation|Mean
149420|NCT00393484|Secondary|Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240|Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay.|At Weeks 24, 48, 96, 144, 192, and 240|Randomized participants who received at least 1 dose of study drug||log10 copies/mL||Standard Deviation|Mean
149421|NCT00393484|Secondary|Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96|The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint.|At Weeks 24, 48, and 96|Randomized participants who received at least 1 dose of study drug||Participants|||Number
149422|NCT00393484|Primary|Percentage of Participants Who Achieved a Virologic Response at Week 24|Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.|At Week 24|Randomized participants who received at least 1 dose of study drug||Percentage of participants|||Number
149853|NCT00389207|Secondary|Treatment-emergent AIDS-defining Illness|Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment|From baseline to Week 144|FAS||Patients|||Number
149423|NCT00393458|Secondary|Percentage of Days of Poor Control During 52 Weeks of Treatment|Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Baseline to end of study (Week 52)|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.||Percentage of days||Standard Error|Least Squares Mean
149424|NCT00393458|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|Week 12 + 1 day, Day 85|Modified intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug, excluding patients from a number of centers.||Liters||Standard Error|Least Squares Mean
149425|NCT00393380|Secondary|Disease-free Survival|Disease-free survival|Measured at 1 year|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
149426|NCT00393380|Secondary|Overall Survival|Overall Survival|Measured at 2 years|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
149427|NCT00393380|Secondary|Cumulative Incidence of Relapse|Cumulative Incidence of Relapse|Measured at 2 years|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
149428|NCT00393380|Secondary|100-day Transplant-related Mortality|100-day transplant-related mortality|Measured at Day 100|13 patients were transplanted||participants|||Number
149429|NCT00393380|Secondary|Platelet Engraftment (Greater Than 20,000)|Platelet engraftment (greater than 20,000)|Measured at Day 180|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
149430|NCT00393380|Secondary|Cumulative Incidence of Chronic GVHD|Cumulative Incidence of Chronic GVHD|Measured at 2 years|13 patients were transplanted.||percentage of participants||95% Confidence Interval|Number
149431|NCT00393380|Secondary|Cumulative Incidence of Acute GVHD Grades II-IV at Day 100|Cumulative Incidence of Acute GVHD Grades II-IV at day 100|Measured at Day 100|13 patients were transplanted||percentage of participants||95% Confidence Interval|Number
149432|NCT00393380|Primary|Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)|Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)|Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.|13 patients received the transplant.||days||Full Range|Median
149433|NCT00393367|Secondary|Serious Adverse Events|Serious Adverse Events|0-5 days|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.||participants|||Number
149434|NCT00393367|Secondary|Number of Participants With Adverse Events (Non-serious).||within 30 days of the ED visit|Of the 180 patients randomized, 91 were to BIS, 89 were to placebo. Two patients were lost to follow-up in the BIS group and 4 in the placebo group.||Participants|||Number
149435|NCT00393367|Primary|Mean Change in Asthma Score at 2 Hours|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).||Units on a scale||95% Confidence Interval|Mean
149436|NCT00393367|Secondary|Relapse / Readmission Numbers.|Participants admitted to the hospital within 5 days of the ED visit|within 5 days of ED visit|89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.||Participants|||Number
149437|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Mild Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.||Participants|||Number
149438|NCT00393367|Secondary|Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.||Participants|||Number
149439|NCT00393367|Secondary|Number of Subjects Remaining in the Severe Asthma Category|Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.|From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|Number of patients who presented in the severe asthma category (Asthma Score 12-15) who remained in that category 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.||Participants|||Number
149440|NCT00393367|Secondary|Oxygen Saturation.|Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.|2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator|||Percent Hemoglobin Saturation||95% Confidence Interval|Mean
149441|NCT00393367|Secondary|Mean Change in Respiratory Rate.|Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.|Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator|||Breaths per minute||95% Confidence Interval|Mean
149442|NCT00393367|Secondary|Change in Mean Heart Rate|Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol|From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator|||Beats per minute||95% Confidence Interval|Mean
149443|NCT00393367|Secondary|Number of Patients Hospitalized|The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.|within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo|||Participants|||Number
149444|NCT00393367|Primary|Median Change in Asthma Score 2 Hours After Intervention|The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.|Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator|88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).||Units on a scale||Full Range|Median
149445|NCT00393094|Primary|Radiographic Response Rate (Glioblastoma Multiforme Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|||Percent of participants|||Number
149446|NCT00393094|Primary|Radiographic Response Rate (Anaplastic Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.||Percent of participants|||Number
149447|NCT00393094|Primary|Number of Participants With Toxicity as Measured by The National Cancer Institute (NCI) Common Toxicity Criteria v. 3.0.|Here is the number of participants with any toxicity, defined as any adverse events possibly, probably or definitely related to the investigational drugs. For the detailed list of investigational new drug (IND)-related toxicities and other serious adverse events, see the adverse event module.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.||Participants|||Number
149448|NCT00393094|Primary|Radiographic Response Rate (Malignant Glioma Participants)|Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline.|23 months (date of first enrollment to 1 month after last progression)|Analysis is per protocol (N=30), excluding the 1 patient who progressed and withdrew consent prior to any treatment but after enrollment.||Percent of participants|||Number
149449|NCT00393068|Secondary|Overall Survival||32 months||||||
149450|NCT00393068|Secondary|Progression-Free Survival||32 months||||||
149451|NCT00393068|Primary|Pathologic Complete Response (pCR) Rate||18 months|||participants|||Number
149452|NCT00393029|Secondary|In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants|Survival of TCR gene-engineered cells is defined as >10% murine TCR positive cells.|3-12 months|||participants|||Number
149453|NCT00393029|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. Adverse events were described using the Common Terminology Criteria for Adverse Events (CTCAE) version 3. For the detailed list of adverse events see the adverse event module.|events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.|||participants|||Number
149454|NCT00393029|Primary|Clinical Tumor Regression|"Response Evaluation Criteria In Solid Tumors (RECIST).~See the protocol Link module for full criteria if desired."|1-11 months|||Participants|||Number
149601|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population||13 Cycles, 28 days each (1 year)|MITT Population, All Subjects 18-45 years old, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population||Pregnancy Rate|Participants||Number
149455|NCT00392925|Secondary|Number of Participants With Treatment-emergent Anti-Leptin Antibodies by Week 4, Week 8, Week 12, Week 16 - Intent to Treat Population|Serum titer determinations for antibodies to leptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to leptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline. All participants were evaluated (including those who did not receive metreleptin as their randomized study drug). Baseline was Day 1 (randomization).|Baseline up to Week 16|The Intent-To-Treat (ITT) Population includes all randomized participants who received at least 1 injection of any component of the randomized study medication; n=number with non-missing data at visit in each treatment group.||participants|||Number
149456|NCT00392925|Secondary|Number of Participants With Clinically Significant Abnormal ECG at Weeks 16, 20, or Early Termination - Randomized Population|A 12-Lead electrocardiogram (ECG) was obtained at Week -4, Day 1, Week 16, Week 20 or early termination and the overall interpretation of the ECG was made by the investigator as normal, abnormal (not clinically significant) and abnormal (clinically significant). The ECG consisted of the PR interval = time from beginning of the P wave to the beginning of the QRS complex; (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS (time from the beginning to the end of the QRS complex) interval; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). .|Weeks 16, 20, early termination|All participants who were enrolled and randomized and had ECGs performed at Weeks 16, 20, or early termination. n=number of participants with ECGs at visit by treatment group.||participants|||Number
149457|NCT00392925|Secondary|Number of Hematology and Urinalysis Values of Potential Clinical Importance - Enrolled Population|Number of laboratory values of potential clinical importance (not participants) observed. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Time frame of evaluation differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing vital signs data at Week -4. n=number with non-missing data in each treatment group||participants|||Number
149458|NCT00392925|Secondary|Number of Chemistry Values of Potential Clinical Importance - Enrolled Population|Number of values (not participants). Greater than (>), Less than (<), high (H), low (L). Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin H > 2 mg/dL; glucose fasting or non-fasting H >200 mg/dL, L <60 mg/dL; Albumin L <2.5 g/dL; Creatine Phosphokinase (CPK) H >3*Upper limit of Normal (ULN); Sodium L<130 milliequivalents per liter (mEq/L), H >150 mEq/L; potassium L<3.0 mEq/L, H>5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8 mg/dL, H>11 mg/dL; triglycerides H>500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H >3*ULN; Gamma-glutamyltransferase (GGT) H>3*ULN; creatinine males >1.6 mg/dL, females >1.4 mg/dL; alanine aminotransferase (ALT) H >3*ULN; aspartate aminotransferase (AST) H >3*ULN; urea nitrogen H >45 mg/dL; uric acid males >10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L <1.0 mg/dL H >6.0 mg/dL. Time frame differs depending on randomization status.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|The Enrolled Population includes all enrolled participants who received at least 1 dose of pramlintide during the 4-week lead-in period or who had nonmissing data at Week -4. n=number with non-missing data in each treatment group who were in the analysis.||laboratory values|||Number
149459|NCT00392925|Secondary|Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Heart Rate - Enrolled Population|Enrollment was Visit 2 (Week -4). Heart rate was measured after the participant rested for 5 minutes and was sitting. Heart Rate was measured in beats per minute (bpm). Vital signs were taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT: those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.||beats/min||Standard Deviation|Mean
149460|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week -2, Week 16 and Week 20 in Systolic and Diastolic Blood Pressure - Enrolled Population|Enrollment was Visit 2 (Week -4). Blood pressure (BP) was measured after 5 minutes of quiet rest with the participant in a sitting position and was measured in millimeters of mercury (mm Hg). Blood pressure was taken at each visit (screening, Week -4, Week -2, Day 1, Weeks 4, 8, 12, 16, 20 (or early termination). After the Lead-In Period, participants were either randomized to one of the 3 arms of the study or they were dropped from the study so the time frame for evaluation of all participants in the study was either: enrollment up to Week 20 for Randomized participants or enrollment up to, but not including Day 1 for Non-Randomized participants who participated only in the Lead-In Period.|Enrollment up to Week 20(Randomized Group) or Enrollment up to, not including Day 1(Non-Randomized Group)|ITT:those randomized, received at least 1 injection of any component of the randomized medication. Enrolled not randomized: those who received at least 1 dose of pramlintide in 4-week lead-in period. n=number with non-missing data at visit in each treatment group.||mm Hg||Standard Deviation|Mean
149500|NCT00392782|Secondary|Incidence of Chronic Graft-versus-host Disease (GVHD)|"Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD."|1 Year|||Participants|||Number
149461|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Hospital Anxiety and Depression Scale (HADS) - Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. The lower the score the more improvement a participant shows.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number with non-missing data in each treatment group were analyzed (n).||units on a scale||Standard Error|Least Squares Mean
149462|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcomes (PRO) for Eating Behavior - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO for eating behavior: Binge Eating Scale (BES) Total Score (16-item questionnaire assessed the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Minimum and maximum scores were 0 and 55, respectively); Susceptibility to Eating Questionnaire (SEQ) Total Score (measure of appetite, satiety, and perceived control over portion size using 10 VAS items with each response measured on a 100 mm visual analogue scale [ranges vary from Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong]. Responses to these items rated over the past 7 days;|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.||units on a scale||Standard Error|Least Squares Mean
149463|NCT00392925|Secondary|LS Mean Absolute Change From Enrollment to Week 16 in Patient Reported Outcome (PRO) Instruments Measuring Quality of Life and Mood - Evaluable Population|Enrollment was Visit 2 (Week -4). PRO: Total Score in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite), 31-item instrument used to assess the effect of weight on physical function, self-esteem, sexual life, public distress, and work. Individual items range from 1 to 5 with 5=always true and 1= never true. Total score measured on scale from 0 (worst) to 100 (best). Higher scores indicate improvement; Profile of Mood States (POMS), 65 mood adjectives that assess participants' mood over the past seven days. The POMS-B is an authorized, 30-item brief version of the POMS consisting of five items for each: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scores range from 0= Not at All to 4=Extremely. Factor scores added for total score. Lower score indicates improvement. 0=best outcome; 120=worst outcome.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group. (POMS)n=19, 38, 36; (IWQOL-Lite)n=19, 38, 36||units on a scale||Standard Error|Least Squares Mean
149464|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Insulin - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Total insulin was measured in micro international units per milliliter (µIU/mL)|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.||µIU/mL||Standard Deviation|Mean
149465|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline and Week 16 in Fasting Total Amylin -Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting total plasma amylin (peptide produced by beta cells in the pancreas) concentration was measured in picomolar (pM) and samples were obtained at screening, enrollment, baseline, Week 4 and Week 16.|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number analyzed with non-missing data at visit.||pM||Standard Deviation|Mean
149466|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Baseline, Weeks 4 and 16 in Fasting Total Leptin Concentration - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Leptin was measured in nanograms per milliliter (ng/mL). Plasma total leptin (including endogenous leptin and exogenous metreleptin) concentrations were measured using a validated sandwich-type immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. This assay is not specific for metreleptin and detects both endogenous leptin and exogenous recombinant-methionyl human leptin [metreleptin]).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data at visit in each treatment group.||ng/mL||Standard Deviation|Mean
149467|NCT00392925|Secondary|Mean Absolute Change From Enrollment to Week 16 in Fasting Glucose and Lipids - Evaluable Population|Enrollment was Visit 2 (Week -4). Baseline refers to Visit 4 (Day 1 of randomization period). Fasting Lipids included: total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and Triglycerides. Fasting Glucose and Lipids were measured in milligrams per deciliter (mg/dL).|Enrollment to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing data for lipids and glucose in each treatment group.||mg/dL||Standard Deviation|Mean
149501|NCT00392782|Secondary|Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)|"Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening."|Day 100|||Participants|||Number
149502|NCT00392782|Secondary|Incidence of Disease Relapse|Number of patients with disease at 1 year.|1 Year|||Participants|||Number
149468|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 20 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were obese at enrollment were still obese at Week 20 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 20 to see if the same number who were overweight at enrollment were still overweight at Week 20 or if they had changed to normal (or obese).|Enrollment up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 20 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 20.||participants|||Number
149469|NCT00392925|Secondary|Number of Participants With BMI Change From Enrollment to Week 16 - Evaluable Population|BMI was measured as kilogram per meter of height squared (kg/m^2). Enrollment was Visit 2 (Week -4). Participants who were obese (BMI of 30 kg/m^2 to <35 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were obese at enrollment were still obese at Week 16 or if they had changed to an BMI of overweight (BMI of 25 kg/m^2 to <30 kg/m^2) or a BMI of normal (BMI of <25 kg/m^2) or a greater obesity (BMI >35 kg/m^2). Participants who were overweight (BMI of 25 kg/m^2 to <30 kg/m^2) at enrollment were evaluated at Week 16 to see if the same number who were overweight at enrollment were still overweight at Week 16 or if they had changed to normal (or obese).|Enrollment up to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. Number analyzed were those participants with non-missing BMI data at enrollment and Week 16.||participants|||Number
149470|NCT00392925|Secondary|LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population|Screening (Week -5 or -6) was the first visit for a participant. This first visit determined participant eligibility and occurred prior to enrollment (Week -4). Hip circumference was measured in centimeters (cm).|Screening up to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Those excluded from the Evaluable Population were identified prior to the unblinding process. Number with non-missing anthropometric data in each treatment group were analyzed.||cm||Standard Error|Least Squares Mean
149471|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Baseline was Visit 4 (Day 1 of randomization period). Waist circumference was measured in centimeters (cm).|Baseline to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.||cm||Standard Error|Least Squares Mean
149472|NCT00392925|Secondary|LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population|Waist circumference was measured in centimeters (cm). Least Squares mean = LS mean. Enrollment was Visit 2 (Week -4) which was the start of the 4 week Lead-In Period. At Day 1, the participant was randomized to one of the 3 study arms and the participant was treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol (per sponsor). Those excluded from Evaluable were identified prior to unblinding. n=number with non-missing anthropometric data at visit in each treatment group.||cm||Standard Error|Least Squares Mean
149473|NCT00392925|Secondary|LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population|Excess body weight: the difference between a participant’s actual body weight and the weight a participant of his/her height would have if his/her BMI were 24.9 kg/m2. Excess body weight at a given visit was calculated as body weight in kilograms (kg) at that visit minus 24.9 × height in meters (m)^2 or 0, whichever was greater. If a participant achieved a normal BMI (24.9 kg/m^2), that subject was considered to have no excess weight. Additional weight loss that occurred after a normal BMI was achieved was not included in the calculation of excess weight loss. Enrollment was Visit 2 (Week -4), the start of the Lead-In Period. Baseline was Day 1 of the randomization to a study arm.|Enrollment to Baseline|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. Number with non-missing body weight data at Day 1 of Randomization were analyzed.||percentage of change||Standard Error|Least Squares Mean
149474|NCT00392925|Secondary|Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population|Baseline refers to Visit 4 (Day 1 of randomization period). Number of participants with 5% or more and 10% or more change in weight from baseline at each visit. Number of participants with 5% or more change in weight that was sustained through Week 16. Number of participants with 10% or more change in weight that was sustained through Week 20.|Baseline to Weeks 16 and Weeks 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||participants|||Number
149475|NCT00392925|Secondary|Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population|Initial (Day 1 through Week 12), late (Week 12 through Week 20), and overall (Day 1 through Week 20) rates of Least squares (LS) mean absolute change in body weight were defined by the slopes of the regression lines fitted to the observed body weights during the periods from Baseline (Day 1) through each visit to Week 20. Initial, late and overall absolute change was measured in kilograms of body weight per week (kg/week). Baseline refers to Visit 4 (Day 1 of randomization period).|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process.||kg/week||Standard Error|Least Squares Mean
149503|NCT00392782|Primary|Incidence of Disease-free Survival|Number of patients alive and without disease at 1 year after transplant.|1 Year|||Participants|||Number
149476|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change is percentage that body weight changed over time at each visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and treated up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||percentage of change||Standard Error|Least Squares Mean
149477|NCT00392925|Secondary|LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean change in body weight as measured in kilograms (kg) from enrollment to each study visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and the participant was treated as per that arm up to Week 20.|Enrollment to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||kg||Standard Error|Least Squares Mean
149478|NCT00392925|Secondary|LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population|Least Squares (LS) mean absolute change in body weight as measured in kilograms (kg) from baseline to Weeks 4, 8, 12, 20. Baseline defined as Day 1 of randomized treatment|Baseline to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||kg||Standard Error|Least Squares Mean
149479|NCT00392925|Secondary|LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population|Least Squares (LS) mean percent change in body weight from baseline to Weeks 4 through 20. Baseline defined as Day 1 of randomized treatment.|Baseline up to Week 20|Evaluable: randomized with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with protocol (per sponsor). Those excluded were identified prior to the unblinding process. n=number with non-missing body weight data (at visit) in each treatment group.||percentage of change||Standard Error|Least Squares Mean
149480|NCT00392925|Primary|Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population|Absolute change in body weight as measured in kilograms (kg) from baseline to Week 16. Baseline defined as Day 1 of randomized treatment.|Baseline to Week 16|Evaluable: randomized participants with at least 1 dose of any treatment; completed Week 16 procedures and adequately complied with the protocol as per the sponsor. Participants excluded from the Evaluable Population were identified prior to the unblinding process. n=number with non-missing body weight data at Week 16 in each treatment group.||kg||Standard Error|Least Squares Mean
149481|NCT00392860|Primary|Change in Functional Status Score|The Functional Status Scale, which measures hand and wrist symptoms.|Baseline, 4 Months|Zero participants were analyzed because only 4 participants were enrolled in this trial. Analyzing the results would not result in any meaningful information. The manufacturer of the PalmRim decided not to pursue the design and development of the product. As a result, the PalmRim experiment arm did not enroll any participants.|||||
149482|NCT00392834|Secondary|Correlation of EBV Load Measurements With OS, FFS, and EFS||baseline through 2 years post-treatment||||||
149483|NCT00392834|Secondary|Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS||baseline through 2 years post-treatment||||||
149484|NCT00392834|Secondary|Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results||baseline||||||
149485|NCT00392834|Secondary|Utility of Flow Cytometry in Detecting Leptomeningeal Disease||baseline and 6-8 weeks post-treatment||||||
149486|NCT00392834|Secondary|Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS||baseline through 2 years post-treatment||||||
149487|NCT00392834|Secondary|Incidence of Infection-related Deaths||baseline through 2 years post-treatment||||||
149488|NCT00392834|Secondary|Toxicity||baseline through 2 years post-treatment||||||
149489|NCT00392834|Secondary|Event-free Survival (EFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years||||||
149490|NCT00392834|Secondary|Failure-free Survival (FFS)||6-8 weeks post treatment, every 4 months post-treatment for 2 years||||||
149491|NCT00392834|Secondary|Complete Response Rate||6-8 weeks post treatment, every 4 months post-treatment for 2 years||||||
149492|NCT00392834|Primary|Overall Survival (OS) at 1 Year||1 year post treatment|||Cumulative proportion surviving at 1 yr||95% Confidence Interval|Number
149493|NCT00392821|Secondary|Progression-Free Survival.|Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions.|18 months|||Months||95% Confidence Interval|Median
149494|NCT00392821|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment||18 months|||percentage of evaluable patients||95% Confidence Interval|Number
149495|NCT00392808|Primary|Serum Antibody Titers Against Haemophilus Influenzae Type b.||One year|||GMCs||95% Confidence Interval|Geometric Mean
149496|NCT00392808|Primary|Serum Bactericidal Activity Against MenC||One month after booster dose|||GMTs||95% Confidence Interval|Geometric Mean
149497|NCT00392782|Secondary|Overall Survival|Number of patients who were deceased at 1 year post transplant.|1 Year|||Participants|||Number
149498|NCT00392782|Secondary|Transplant-related Mortality|Number of patients with treatment related death at 1 year post transplant.|1 Year|||Participants|||Number
149499|NCT00392782|Secondary|Incidence of Graft Failure|Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.|Day 100|||Participants|||Number
149548|NCT00391989|Secondary|The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study||||||
149549|NCT00391989|Secondary|The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;||End of study||||||
149504|NCT00392769|Primary|Overall Disease Control Rate|Overall disease control rate also called the Clinical Benefit Response (CBR) is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment, using Bayesian design.|Overall disease control rate (CR + PR + SD) evaluated within 8 weeks (CR or PR) and 12 weeks (SD) of initial treatment.|There were ten inevaluable participants (completing less than 1 cycle).||percentage of participants|||Number
149505|NCT00392704|Secondary|Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment|24 Months|||percentage of patients|||Number
149506|NCT00392704|Primary|Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment|The percentage of patients estimated to be alive 2 years after beginning protocol treatment|24 months|All participants in this study were assessed and included in the progression free survival analysis||percentage of participants|||Number
149507|NCT00392678|Secondary|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in C-peptide from Baseline to Week 14 is in the data table below|Baseline, week 14|||C-peptide in nmol/l||95% Confidence Interval|Mean
149508|NCT00392678|Secondary|Safety and Tolerability of Salsalate Compared to Placebo as Assessed by Adverse Events.|See adverse event module for details.|14 weeks|||participants|||Number
149509|NCT00392678|Secondary|Response Rates for a Reduction in HbA1c for Obese vs Non-obese Participants|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14-26 week||||||
149510|NCT00392678|Secondary|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14-26 week||||||
149511|NCT00392678|Secondary|Need for Discontinuation of Study Medication|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14 week||||||
149512|NCT00392678|Secondary|Need for Rescue Therapy|This aim was proposed for the TINSAL-T2D stage 2 trial and is separately reported.|14 weeks||||||
149513|NCT00392678|Secondary|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups|Please see adverse events module for hyperglycemia.|14 week||||||
149514|NCT00392678|Secondary|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index|HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in insulin from Baseline to Week 14 in data table below.|Baseline, week 14|||pmol/l||Inter-Quartile Range|Median
149515|NCT00392678|Secondary|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)|LDL-C/HDL-C ratio not calculated|14 week|||mg/dl||95% Confidence Interval|Mean
149516|NCT00392678|Secondary|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%|This was an aim proposed for the longer duration study and is reported under TINSAL-T2D stage 2.|14-26 week||||||
149517|NCT00392678|Secondary|Change From Baseline and Trends in Fasting Glucose Over Time||14 week|||mg/dl||95% Confidence Interval|Mean
149518|NCT00392678|Secondary|Change From Baseline to Either 14 or 26 Weeks, or Last HbA1c Measurement Prior to Rescue Therapy|see primary outcome|14 week|||% HbA1c||95% Confidence Interval|Mean
149519|NCT00392678|Primary|The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 14 (Stage 1) in the Intent-to-treat (ITT) Population With Last Observation Carried Forward.||14 week|||% (units of HbA1c)||95% Confidence Interval|Mean
149520|NCT00392496|Primary|Objective Tumor Response|It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin’s lymphoma and reviewed independently|Up to 3 years|patients evaluable for response||participants|||Number
149521|NCT00392444|Primary|Objective Response (Partial and Complete) Per RECIST|Number of patients who had objective responses after radiology review|Up to 3 years|1 cancelled patient and 4 ineligible patients were excluded from analysis.||participants|||Number
149522|NCT00392392|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery|Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).|18 months|Two patients refused surgery after completing six cycles of pre-operative (neoadjuvant) therapy.||percentage of participants|||Number
149523|NCT00392379|Secondary|Prolonged Smokeless Tobacco Abstinence at 6 Months|Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).|6 months|||Participants|||Number
149524|NCT00392379|Secondary|Self-reported Point Prevalence All Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.|3 months|||Participants|||Number
149525|NCT00392379|Primary|Prolonged Smokeless Tobacco Abstinence at 3 Months|Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.|3 months|ITT||Participants|||Number
149526|NCT00392288|Secondary|Change From Baseline in Use of Albuterol/Salbutamol at Week 12.|Change in albuterol/salbutamol use from baseline to week 12|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.||Puffs per day||Standard Error|Least Squares Mean
149527|NCT00392288|Secondary|Change From Baseline in Total Daily Asthma Symptom Score at Week 12.|Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement.||Scores on a scale||Standard Error|Least Squares Mean
149602|NCT00391807|Secondary|Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population|MITT Population|2 Cycles, 28 days each (56 days)|MITT Population||Bleeding/Spotting Days||Standard Deviation|Mean
149528|NCT00392288|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.|Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.|Baseline and Week 12|Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. The primary analysis was restricted to an age range between 6 and <12 years.||Percent of predicted FEV1||Standard Error|Least Squares Mean
149529|NCT00392236|Secondary|Quality of Life Interview (Short Version)||Measured at Month 6||||||
149530|NCT00392236|Secondary|Self Appraisal of Illness Questionnaire||Measured at Month 6||||||
149531|NCT00392236|Secondary|Brief Psychiatric Rating Scale (BPRS) and Modified Scale for the Assessment of Negative Symptoms (SANS)||Measured at Month 6||||||
149532|NCT00392236|Secondary|Drug Attitude Inventory||Measured at Month 6||||||
149533|NCT00392236|Secondary|Multidimensional Scale of Independent Functioning||Measured at Month 6||||||
149534|NCT00392236|Primary|Percent of Prescribed Doses Taken as Assessed by the Medication Event Monitoring System (MEMS)|Estimated percent of doses taken during month 6 of the study was calculated using all available data sources (MEMS supplemented by subject interview and pill counts).|Measured at Month 6|||percentage of medication doses taken at||Standard Deviation|Mean
149535|NCT00392223|Secondary|Change From Baseline in Acne Graded by Leeds Technique|Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).||score on scale||95% Confidence Interval|Mean
149536|NCT00392223|Primary|Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 EOT|Per Protocol population||score on scale||95% Confidence Interval|Least Squares Mean
149537|NCT00392223|Secondary|Improvement of Global Acne Grading System (GAGS) Score|Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 – 75%; Moderate improvement : reduction score > 25 – 50%; Light improvement : reduction score > 0 – 25%; No change = reduction score = 0%; Worsening = increase score > 0 %.|Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.||participants|||Number
149538|NCT00392223|Post-Hoc|Number of Subjects With Mild, Moderate, and Severe Acne|Global Acne Grading System score used to assess 6 locations on face/chest/upper back; factor for each based on area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on sum of local scores and se verity: 0=no acne, 1-18=mild, 19-30=moderate, 31-38=severe, >39=very severe.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used.||participants|||Number
149539|NCT00392223|Secondary|Change From Baseline in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.|Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT|Full Analysis Set. Where noted: LOCF = Last Observation Carried Forward technique was used. Number of subjects with analyzable data: n=azithromycin, minocycline (respectively).||score on scale||95% Confidence Interval|Mean
149540|NCT00392223|Primary|Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score|GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.|Baseline, Week 8 End of Treatment (EOT)|Full Analysis Set, Last Observation Carried Forward (LOCF)||score on scale||95% Confidence Interval|Least Squares Mean
149541|NCT00392197|Secondary|HbA1c|The number of subjects with an HbA1c value of 6.5% or higher were calculated. In addition, for 5.8% and above, the number of subjects were also calculated, in the same way|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation|||participants|||Number
149542|NCT00392197|Primary|Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)|The number of subjects whose FBS level reached or exceeded 126 mg/dL (200 mg/dL, non-FBS level) at least once during the test product administration period as well as the incidence were determined. Also, for 110 mg/dL and above (140 mg/dL, non-FBS level), the number of subjects were determined in the same way.|Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation|Subjects who were treated with at least 1 tablet of the test product, and whose blood glucose level was measured at least once after test product administration were included in the glucose metabolism analysis set. However, subjects who violated inclusion criteria and exclusion criteria were excluded.||participants|||Number
149543|NCT00392171|Primary|Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.|Progression-free survival as determined by Kaplan-Meier method.|6 months|"Participants who received allocated intervention.~The percentage of participants reported is based on the number of participants within each category (not total number of all categories combined)."||Percentage of Participants|||Number
149544|NCT00391989|Secondary|OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.||End of study||||||
149545|NCT00391989|Secondary|the Cumulative Incidence of Relapse;||End of study||||||
149546|NCT00391989|Secondary|DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;||End of study||||||
149547|NCT00391989|Secondary|the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;||End of study||||||
149551|NCT00391976|Secondary|Number of Participants Hospitalized for Pulmonary Exacerbations|Core study defined as from Baseline through to one month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group). Follow-up phase began at the end of the core study through to the end of the study (Month 27).|From Baseline to end of study (27 months)|All patients who were randomized and received at least one dose of study medication. Non-randomized patients were not included in the analysis.||Participants|||Number
149552|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Having an Increased, Decreased, or Unchanged Tobramycin Minimum Inhibitory Concentration (MIC) Value at the Final Visit Compared to Baseline|The percentage of patients with changes in tobramycin MIC values from Baseline to the final visit could not be compared as there was insufficient data.|From Baseline to the final visit (end of the study, Month 27)|Safety population: All patients who were enrolled in the study and received at least 1 dose of study medication.||Percentage of participants|||Number
149553|NCT00391976|Secondary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (New or Same Genotype) in Sputum or Deep Throat Cough Swab Based on Confirmatory Assessment by the Central Laboratory|Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.||Months||95% Confidence Interval|Median
149554|NCT00391976|Secondary|Percentage of Patients With Pseudomonas (P.) Aeruginosa Eradicated From Deep Throat Cough Swab or Sputum|One month after the end of treatment was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group.|From 1 month after the end of treatment until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.||Percentage of participants|||Number
149555|NCT00391976|Primary|Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab|Microbiological samples were obtained from sputum or by deep throat cough swab technique. Time to recurrence was defined as the time between the visit at 1 month after the end of treatment (when eradication was confirmed) and the time of the first positive culture with any genotype of P. aeruginosa. Time zero was Day 56 (Month 2) for the 28-day treatment group and Month 3 for the 56-day treatment group. Kaplan-Meier estimates were used.|From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27)|Efficacy evaluable population: All randomized patients who had microbiological assessments 1 month after their last dose of study drug, except for patients with no eradication 1 month after the last dose of study drug, low compliance (> 50% of capsules returned unused), or violation of protocol procedure in relation to the efficacy analysis.||Months||95% Confidence Interval|Median
149556|NCT00391898|Secondary|Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3|The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Positive answers||Standard Deviation|Mean
149557|NCT00391898|Secondary|Patient and Investigator Global Evaluation of the Patient|Both the patient and the investigator made an evaluation of the change in the patient’s condition by rating the condition of the patient at the end of the study compared to patient’s condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
149558|NCT00391898|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3|The PDQ-39 is an instrument used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognitions, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 195. A lower score indicates better quality of life. A positive change score indicates an improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
149559|NCT00391898|Secondary|Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3|Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
149560|NCT00391898|Secondary|Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient’s motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
149603|NCT00391807|Primary|Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population,||13 cycles, 28 days each (1 year)|Modified Intent to Treat Population (MITT), Women Aged 18-35, 27 women had no cycles evaluable for pregnancy because they used alternative contraceptive methods in all cycles - 1555 subjects evaluable in MITT population. Number of pregnancies per 100 women-years of treatment in MITT Population||Pregnancy Rate|Participants||Number
149561|NCT00391898|Secondary|Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient’s mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with LOCF||Units on a scale||Standard Deviation|Mean
149562|NCT00391898|Primary|Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3|The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.|Baseline to end of study (Month 3)|Per Protocol set with the last observation carried forward (LOCF)||Units on a scale||Standard Deviation|Mean
149563|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by TIMI cardiologists.|1-week period following randomization|Patients who were monitored for one week following randomization (and for one week one month later).||Participants|||Number
149564|NCT00391872|Secondary|Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization|Number of participants who were observed to have at least 1 ventricular pause of at least 3 seconds. Population is all patients who were observed over 2 week-long periods. Pauses were flagged algorithmically and confirmed by Thrombolysis in Myocardial Infarction (TIMI) group cardiologists.|1-week period following randomization|Participants with Holter data in the week after Randomization||Participants|||Number
149565|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding|Number of participants with a major fatal/life-threatening CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.||Participants|||Number
149566|NCT00391872|Secondary|Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding|Participants with a major CABG-related bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. All CABG surgeries were submitted for adjudication by an endpoint committee as potential bleeds.|First dosing up to 12 months|Population is all patients who underwent CABG surgery within 7 days of last dose of active study medication.||Participants|||Number
149567|NCT00391872|Secondary|Participants With Non-procedural Major Bleeding|Participants with non-procedural major bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
149568|NCT00391872|Secondary|Participants With Major or Minor Bleeding|Participants with major (fatal/life-threatening or other) or minor bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
149569|NCT00391872|Secondary|Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding|Participants with non CABG related major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
149570|NCT00391872|Secondary|Participants With Death From Any Cause|Participants with death from any cause. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
149571|NCT00391872|Secondary|Participants With Stroke|Participants with stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
149572|NCT00391872|Secondary|Participants With Death From Vascular Causes|Participants with death from vascular causes. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
149573|NCT00391872|Secondary|Participants With MI Event|Participants with MI event. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT (intention to treat) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
149574|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.|Participants with death from vascular causes, MI, stroke, recurrent ischemia, or other thrombotic events. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
149575|NCT00391872|Secondary|Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke|Participants with death from any cause, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal of consent or date of scheduled withdrawal from therapy. ITT analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
149576|NCT00391872|Secondary|Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The subgroup of patients with intent for invasive management at randomization||Participants|||Number
149577|NCT00391872|Primary|Participants With Any Major Bleeding Event|Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.|First dosing up to 12 months|The population was the safety analysis set, which included all randomized patients who took at least one dose of study drug||Participants|||Number
149578|NCT00391872|Primary|Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke|Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.|Randomization up to 12 months|The population was the full analysis set, which included all randomized patients||Participants|||Number
149579|NCT00391846|Secondary|Discontinuations|Number of patients discontinued due to adverse events’|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Participants|||Number
149580|NCT00391846|Secondary|Total Number of Titration Steps in Prescribed Heart Failure Treatment|Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Titration steps|||Number
149581|NCT00391846|Secondary|Changes in Health-related Quality of Life|Change range –100 to 100. The higher the better.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||KCCQ overall score||Standard Error|Mean
149582|NCT00391846|Secondary|Changes in NT-proBNP Values Over Time in All Patients|The 95% confidential interval (CI) is given as measure of dispersion|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||ng/L||95% Confidence Interval|Geometric Mean
149583|NCT00391846|Secondary|Changes in Heart Failure Symptoms|Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.|9 months and baseline|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Categorial scale||Standard Deviation|Mean
149584|NCT00391846|Secondary|Number of Days in Hospital for CV Reason|Each overnight stay is counted as one day. The lower the better|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Days in hospital||Standard Deviation|Mean
149585|NCT00391846|Secondary|Number of CV Deaths|Number of deaths|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Participants|||Number
149586|NCT00391846|Primary|Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)|The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented|9 months|In the above analysis regarding The number of participants analyzed the ‘last observation carried forward’ principle is used, as pre-specified in the protocol.||Scores on a scale||Standard Deviation|Mean
149587|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population||Percentage of Participants|||Number
149588|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Percentage of Participants|||Number
149589|NCT00391807|Secondary|Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Percentage of Participants|||Number
149590|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population||13 cycles, 28 days each (1 year)|MITT Population||Days||Standard Deviation|Mean
149591|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population||6 cycles, 28 days each (168 days)|MITT Population||Days||Standard Deviation|Mean
149592|NCT00391807|Secondary|Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population||2 cycles, 28 days each (56 days)|MITT Population||Days||Standard Deviation|Mean
149604|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Polymerase Chain Reaction (PCR) to Pharmacokinetic Parameters by Cohort.|The Spearman coefficient and the p-values were computed between the clearance of viral RNA and oseltamivir carboxylate Area Under the Curve from 0 to 12 hours (AUC 0-12)|From date of enrollment until the date of first documented absence of viral load by culture, assessed up to 10 days after enrollment.|Subjects included in this analysis are those who had viral loads at baseline (day 0) and had a non-detectable viral load on one of the following study visit days: day 3, day 5, or day 10. Virus was obtained from a nasal swab. Subjects also would have had evaluable PK samples on study day 3.||correlation measure|||Number
149605|NCT00391768|Secondary|Correlation of Clearance of Viral RNA by Culture With Pharmacokinetic Parameters by Cohort|The Spearman coefficient and the p-values were computed between the clearance of Viral RNA and Oseltamivir Carboxylate Area under the curve from 0 to 12 hours (AUC0-12)|Day to negative viral load for subjects positive at baseline|Subjects included in this analysis are those who had positive culture at baseline (day 0) and had a negative culture on one of the following study visit days: Day 3, Day 5 or Day 10. Culture was obtained from a a nasal swab. Subjects also would have had evaluable PK samples on study day 3.||Spearman coefficient|||Number
149606|NCT00391768|Secondary|Incidence of All Serious Adverse Events by Cohort and System Organ Class (SOC)|Serious Adverse Event (SAE) were classified by MedDRA System Organ Class (SOC). An SAE was reported if it met the following criteria and occurred after the first dose of study medication through the end of the study: death throughout study participation; life threatening; requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance; results in congenital anomaly or birth defect; results in a persistent or significant disability; and an event considered serious by the PI.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days|||Participants|||Number
149607|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort Leading to Discontinuation of Study Medication|Study drug was administered for 5 days; any event that occurred prior to the last dose of study medication that was considered related to an AE and that caused the subject to stop taking study drug.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 5 plus or minus 1 day|||events|||Number
149608|NCT00391768|Secondary|Incidence of Treatment Emergent AEs and Drug Related AEs by Cohort and Toxicity Grade|Any event considered to be related to the study drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately. The Division of AIDS Toxicity Tables (DIAIDS) were used to grade the events.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days|Intention to treat (ITT)||Participants|||Number
149609|NCT00391768|Secondary|Number and Characteristics of Adverse Events (AEs) Described as Neurological Events.|Any neurological event that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)||participants|||Number
149610|NCT00391768|Secondary|Overall Reported Adverse Events (AEs) Thought to be Associated With Study Therapy.|Any event considered associated with drug that occurred post first dose of drug administration that was not present at baseline was considered an AE. Expected flu symptoms were not reported as AEs but were collected separately.|Duration of study, from receipt of the first dose of study drug and continuing through study visit Day 30 plus or minus 3 days.|Intention to treat (ITT)||participants|||Number
149611|NCT00391768|Primary|Oseltamivir Carboxylate AUC12 (Area Under the Curve).|The oseltamivir carboxylate AUC12 was derived from a series of five blood draws over 10 to 12 hours.|Day 3 of drug administration|Subjects that received 3 days study drug administration and had successful PK draws on study day 3.||participants|||Number
149612|NCT00391716|Secondary|Craving|Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.|12-week|||units on a scale||Standard Error|Mean
149613|NCT00391716|Secondary|Sleep|The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.|12-week|||units on a scale||Standard Error|Mean
149614|NCT00391716|Secondary|Mood|Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.|12-week|||units on a scale||Standard Error|Mean
149615|NCT00391716|Primary|Drinking|Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).|12-week|All randomized subjects included in denominator for rate determination.||participants|||Number
149616|NCT00391625|Secondary|Percent Change From Baseline in Spleen Size||Baseline, Month 24, then every 9 or 12 months|ITT (One patient was excluded due to an intravascular metallic device that prevented accurate spleen evaluation.)||Percent Change from Baseline||Standard Error|Mean
149617|NCT00391625|Secondary|Percent Change From Baseline in Liver Volume||Baseline, Month 24, then every 9 or 12 months|ITT||Percent Change from Baseline||Standard Error|Mean
149618|NCT00391625|Secondary|Percent Change From Baseline in Platelet Counts||Baseline, then every 12 months|ITT patient population||Percent Change from Baseline||Standard Error|Mean
149619|NCT00391625|Secondary|Percent Change From Baseline in Hemoglobin Concentration||Baseline, then every 12 months|Intent to treat (ITT) patient population||Percent Change from Baseline||Standard Error|Mean
149620|NCT00391625|Primary|Evaluation of Long Term Safety|Overall Summary of Treatment-emergent Adverse Events-Safety Population|Up to 84 months|ITT patient population||Participants|||Number
149624|NCT00391586|Primary|Toxicity Profile|Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.|28 days after last on-study treatment|||participants|||Number
149625|NCT00391586|Primary|Progression-free Survival (PFS)||5 years|This study was terminated early; no results are available. The number of patients who completed treatment and therefore the number of evaluable patients was too low to accurately calculate endpoints.|||||
149626|NCT00391469|Secondary|Neurologic Status at Discharge-full Recovery||at time of discharge|||participants|||Number
149627|NCT00391469|Primary|Number Alive at Hospital Discharge||at hospital discharge|||participants|||Number
149628|NCT00391443|Secondary|Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|12 months|ITT population||percentage of participants with event||95% Confidence Interval|Number
149629|NCT00391443|Primary|Time to Occurrence of Disease Worsening or Death up to End of Study.|Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).|36 months|The primary analysis was performed on the Intent To Treat (ITT) population.||participants with event|||Number
149630|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds|Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.||Participants|||Number
149631|NCT00391391|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.|Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety parameters were determined post-vaccination in the safety, intend-to-treat population.||Participants|||Number
149632|NCT00391391|Secondary|Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.|Day 28 post-vaccination|Seroconversion to vaccine antigens were determined in the per-protocol population||Percentage of Participants|||Number
149633|NCT00391391|Secondary|Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|"Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.~Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique."|Day 28 post-vaccination|Seroprotection to vaccine antigens were determined in the per-protocol population||Percentage of Participants|||Number
149634|NCT00391391|Secondary|Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 28 post-vaccination|4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population||Percentage of Participants|||Number
149635|NCT00391391|Primary|Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine|Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were determined in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
149636|NCT00391365|Secondary|Bodily Pain Section of Short Form-36 (SF-36)|"Patient reported bodily pain data from the SF-36, a thirty-six item survey evolved from the RAND 36.~Number shows change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 bodily pain data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.||units on a scale||Standard Error|Mean
149637|NCT00391365|Secondary|Physical Function Section of Short Form-36 (SF-36)|"Patient reported physical function data from the SF-36, a thirty-six item survey evolved from the RAND 36.~Change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.)"|Over the course of 3 years.|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 physical function data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.||units on a scale||Standard Error|Mean
149638|NCT00391365|Primary|Musculoskeletal Functional Assessment (MFA)|"Patient reported data using the MFA, a general functional assessment intended as a tool for evaluation of patients' perceptions of their physical, psychological, and social well-being that asks patients to assess their function on 100 items.~Number shows change in outcome from pre-op to 3 years by surgery type, with a lower score implying an improved outcome (scale range 0 -100.)"|Over the course of 3 years|The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the MFA data collected from 99 arthrodesis subjects, and 165 arthroplasty subjects.||units on a scale||Standard Error|Mean
149681|NCT00391027|Secondary|Number of Subjects With Hypoglycemic Events by Severity|Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.|Week 26|FAS||participants|||Number
149639|NCT00391274|Post-Hoc|Number of Patients With Disease Progression|Number of patients who have died or have had progression of disease. This outcome substitutes for the outcome on Duration of Response.|time of response to progressive disease (up to 12 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Patients censored: pemetrexed=6, docetaxel=3.||participants|||Number
149640|NCT00391274|Primary|Overall Survival|Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.|baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)|Intent to treat population. Number of patients censored (up to 24 months): pemetrexed = 51, docetaxel = 55. Number of participants censored (up to 30 months): pemetrexed = 30, docetaxel = 32.||months||95% Confidence Interval|Median
149641|NCT00391274|Secondary|Pharmacology Toxicity|Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.|first dose of study drug up to 24 months|Patients who received at least one dose of study drug.||participants|||Number
149642|NCT00391274|Secondary|Duration of Response|"Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as Number of Patients with Disease Progression."|time of response to progressive disease (up to 24 months)|Patients who qualified for response (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease). Results not presented because median was not calculable for the docetaxel arm.||months||95% Confidence Interval|Median
149643|NCT00391274|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.|baseline to measured progressive disease (up to 24 months after study enrollment)|"Intent to treat population. Patient censored:~pemetrexed=25, docetaxel=39."||months||95% Confidence Interval|Median
149644|NCT00391274|Secondary|Overall Tumor Response|"Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria."|baseline to measured tumor response (up to 24 months after study enrollment)|Patients who received at least one dose of study drug and qualified for tumor response analysis (met following criteria: histologic or cytologic diagnosis of NSCLC that was not amenable to curative therapy; no concurrent systemic chemotherapy; presence of measurable or evaluable disease).||participants|||Number
149645|NCT00391222|Secondary|Time to Recurrence of a Mood Episode (Exploratory/Olanzapine)|Recurrence was defined as for the risperidone LAI and placebo arms (meeting any of 5 criteria). Since the study was designed to compare the efficacy of risperidone LAI versus placebo, this olanzapine analysis was exploratory in nature.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 1 patient in the olanzapine arm (discontinued the study due to non-compliance to the study medication).||days||Standard Error|Mean
149646|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS)|The MADRS was assessed by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. The scale consists of 10 items that cover all of the core depressive symptoms. Each item is scored from 0 to 6 and a total score is calculated by adding the scores of all 10 items. For each individual item as well as for the total score, a higher score represents a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||units on a scale||Standard Error|Mean
149647|NCT00391222|Secondary|Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS)|The 11-item YMRS was administered by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. A severity rating was assigned to each of the items, based on the patient's subjective report of his or her condition over the previous 7 days or since the last visit (whichever was shorter) and the clinician’s behavioral observations during the interview, with emphasis on the latter. The total YMRS score included the score of all 11 items ranging from 0 to 60, a higher score indicating a more severe condition.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||units on a scale||Standard Error|Mean
153039|NCT00360334|Secondary|Change in Fasting Serum Total Cholesterol (TC)|Change in TC from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
149648|NCT00391222|Secondary|Time to Early Study Discontinuation for Any Reason|The robustness of the primary outcome analysis was tested by means of a sensitivity analysis: patients who discontinued the study during Period III for any reason were analyzed as having a recurrence of a mood episode at the time of their study discontinuation. The same survival analysis method as for the primary outcome was applied.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
149649|NCT00391222|Secondary|Time to Recurrence of a Depressive Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of a depressive episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
149650|NCT00391222|Secondary|Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode|Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of an elevated mood episode was estimated by means of the same survival analysis method as for the primary outcome.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
149651|NCT00391222|Primary|Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)|Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) >12 or Montgomery-Åsberg Depression Rating Scale (MADRS) >12 combined with Clinical Global Impression – Severity (CGI-S) >=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.|Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)|ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).||days||Standard Error|Mean
149652|NCT00391092|Secondary|Change From Baseline for FACT-G and FACT-B|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.||units on a scale||Standard Deviation|Mean
149653|NCT00391092|Secondary|Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.|Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])|ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.||units on a scale||Standard Deviation|Mean
149654|NCT00391092|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population||months||95% Confidence Interval|Median
150417|NCT00385138|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|mITT population; (composite incidence)|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
149655|NCT00391092|Secondary|Duration of Response (DR)|DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population: only participants with a best OR of CR or PR were included in the analysis.||months||95% Confidence Interval|Median
149656|NCT00391092|Secondary|Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline|Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population; only participants with measurable disease at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
149657|NCT00391092|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population||months||95% Confidence Interval|Median
149658|NCT00391092|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators’ assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.|Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)|ITT Population||months||95% Confidence Interval|Median
149659|NCT00391079|Secondary|Change in Sleep Disruption NRS|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|14 weeks; Baseline to end of treatment (last 7 days)|||points on a scale||Standard Deviation|Mean
149660|NCT00391079|Secondary|Change in Subject Global Impression of Change (SGIC)|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At baseline subjects wrote a brief description of their pain caused by multiple sclerosis which was used at Week 14 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Week 14|All subjects who completed the question were included in the analysis. Two subjects from the Sativex group and six subjects from the placebo group did not complete the question.||percentage of subjects|||Number
149661|NCT00391079|Secondary|Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|14 weeks: Baseline to end of treatment (last 7 days of treatment)|All subjects who completed the BPI-short form were included in the analysis. Four subjects from the sativex group and three subjects from the placebo group did not complete the form.||Points on a scale||Standard Deviation|Mean
149662|NCT00391079|Secondary|Change From Baseline to End of Treatment in Break-through Analgesia Usage|Use of break through medication was recorded daily during the 14 weeks of the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|14 weeks: baseline - end of treatment (last 7 days)|||tablets||Standard Deviation|Mean
149663|NCT00391079|Secondary|Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|14 weeks: Baseline - End of treatment (Week 14)|||Points on a scale||Standard Deviation|Mean
149664|NCT00391079|Primary|Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. The pain NRS was completed at the same time each day, i.e. bedtime in the evening."|14 weeks: Baseline - end of treatment (last 7 days)|||participants|||Number
149665|NCT00391079|Primary|Change in Mean Pain Due to MS NRS Score|"The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. A negative value indicates an improvement in pain score from baseline."|14 weeks: Baseline - End of Treatment (last 7 days of treatment)|Change in mean daily NRS score||units on a scale||Standard Deviation|Mean
149666|NCT00391053|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination|The occurrence, time to onset, number of days of occurrence, and severity of solicited injection site reactions: Injection Site Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia were collected.|Day 0 to Day 7 Post-vaccination|The safety analysis was performed on the Full Analysis Set according to the participants who actually received a vaccine, whether or not the subject received the assigned vaccine. A total of 3,833 participants were included in the analysis set for the evaluation of all safety.||Percentage of Participants|||Number
149667|NCT00391053|Secondary|Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroprotection was defined as a Hemagglutination Inhibition Titers of at least 40 (≥ 1:40) for each of the Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) pre- or post-vaccination with Fluzone® High-Dose or Standard Fluzone® vaccines.|Day 0 and Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.||Percentage of Participants|||Number
149668|NCT00391053|Primary|Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.|Seroconversion was defined as a Hemagglutination Inhibition Antibody Titers of Titer ≥40 (1/dil) on Day 28 if pre-vaccination (Day 0) titer <10 (1/dil); or a four-fold increase of titer on Day 28, if pre-vaccination (Day 0) titer is ≥10 (1/dil) for each of the three Influenza vaccine antigens (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia).|Day 28 Post-vaccination|The immunogenicity analysis was performed on the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.||Percentage of Participants|||Number
149669|NCT00391053|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.|Antibodies against each of three Influenza antigens (virus) in Fluzone® High-Dose and Standard Fluzone® vaccines (A/H1N1 New-Caledonia; A/H3N2 Wisconsin; and B Malaysia) were determined by the Hemagglutination inhibition assay method.|Day 0 and Day 28 Post-vaccination|The geometric mean titers was assessed in the Full Analysis Set according to the vaccine the subjects were randomized to receive. A total of 3851 participants were included in this analysis.||Titers||95% Confidence Interval|Geometric Mean
149670|NCT00391027|Secondary|Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects|Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.|Baseline, Week 26||||||
149671|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)|Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.|Baseline, Week 26|FAS; LOCF.||pg/ml||Standard Deviation|Mean
149672|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)|Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.|Baseline, Week 26|FAS; LOCF.||ng/ml||Standard Deviation|Mean
149673|NCT00391027|Secondary|Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)|Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.|Baseline, Week 26|FAS; LOCF.||pg/ml||Standard Deviation|Mean
149674|NCT00391027|Secondary|Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)|Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.|Baseline, Week 26|FAS; LOCF.||mg/dl||Standard Deviation|Mean
149675|NCT00391027|Secondary|Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients|The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.|Baseline, Week 26|FAS; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively. Revised table rectifies a programming code error that was determined post-Clinical study report (CSR) approval.||mg/dl||Standard Deviation|Mean
149676|NCT00391027|Secondary|Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health|Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.|Week 26||||||
149677|NCT00391027|Secondary|Number of Subjects Discontinued Due to Insufficient Clinical Response|Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.|Week 26|Safety population: all subjects who received at least 1 dose of study medication.||participants|||Number
149678|NCT00391027|Secondary|Change From Baseline in Body Mass Index (BMI)|BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.|Baseline, Week 26|FAS; LOCF.||kg/m2||Standard Deviation|Mean
149679|NCT00391027|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as body weight at observation minus body weight at baseline.|Baseline, Week 26|FAS; LOCF.||kilograms (kg)||Standard Deviation|Mean
149680|NCT00391027|Secondary|Number of Events of Nocturnal Hypoglycemia|Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.|Week 26|FAS||events|||Number
153040|NCT00360334|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set||mmHg||Standard Error|Least Squares Mean
149682|NCT00391027|Secondary|Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)|Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.|Baseline, Week 26|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.||mg/dl||Standard Deviation|Mean
149683|NCT00391027|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level|FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.|Baseline, Week 26|FAS; LOCF.||mg/dl||Standard Deviation|Mean
149684|NCT00391027|Secondary|Number of Subjects With HbA1c < 8.0 %|Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.|Week 26|FAS||participants|||Number
149685|NCT00391027|Secondary|Number of Subjects With HbA1c < 7.0 %|Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.|Week 26|FAS||participants|||Number
149686|NCT00391027|Secondary|Number of Subjects With HbA1c < 6.5 %|Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.|Week 26|FAS||participants|||Number
149687|NCT00391027|Secondary|Change From Baseline in HbA1c Prior to Week 26|Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18|FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.||percent||Standard Deviation|Mean
149688|NCT00391027|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.|Baseline, Week 26|Full analysis set (FAS) all randomized subjects with at least 1 dose of study medication, baseline and post-baseline HbA1c measurement. Last observation carried forward (LOCF).||percent||Standard Deviation|Mean
149689|NCT00390884|Other Pre-specified|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®|Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination|Days 0-7 Post-vaccination|The safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
149690|NCT00390884|Secondary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|The Geometric Mean Titers were analyzed in the per-protocol immunogenicity population||Titers||95% Confidence Interval|Geometric Mean
149691|NCT00390884|Primary|Percentage of Seroprotected Participants Post-vaccination With Fluzone®|Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Fluzone® vaccine antigens were assessed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
149692|NCT00390858|Primary|Change in Liver Iron Concentration (LIC)|Change in Liver Iron Concentration [LIC] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw)|Baseline of Core Study to End of Extension Study, up to 5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.||mg Fe/g dw||Standard Deviation|Mean
149693|NCT00390858|Secondary|Relative Change in Serum Transferrin Level|Serum Levels were drawn at Baseline of the Core Study and up to 18 months in the Extension Study. Serum was analyzed for transferrin levels measured as grams per Liter. Relative change (%) in serum transferrin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in transferrin level from Baseline/Baseline level) x 100.|Baseline of Core Study to Extension Study 18 months , up to 2.5 years|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.||percent change||Standard Deviation|Mean
149694|NCT00390858|Secondary|Relative Change in Serum Ferritin Level|Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Levels were analyzed for serum ferritin measured in micrograms per Liter. Relative change (%) in serum ferritin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline of Core Study to Extension 18 months, up to 2.5 years.|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.||percent change||Standard Deviation|Mean
149695|NCT00390858|Secondary|Total Body Iron Elimination (TBIE) Rate (mg/kg/Day)|Total Iron Body Elimination (TBIE) Rate [mg/kg/Day] was calculated for each patient based on SQUID ( Superconducting Quantum Interference Device) results.|Baseline of Core Study to End of Extension Study, up to 5 years|The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study.||mg/kg/Day||Standard Deviation|Mean
149696|NCT00390858|Primary|Participants With Adverse Events by Primary System Organ Class (SOC)|Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product.|4 year extension + core 1 year|The safety set comprising of all the 40 patients who received at least one dose of deferasirox during the core or extension study was used in all analyses.||participants|||Number
150219|NCT00385944|Secondary|P2Y12 Reaction Units (PRU)|P2Y12 Reaction Units (PRU) assessed by Accumetrics Verify NowTM P2Y12. PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition.|14 days after maintenance dose (MD)|||PRU||Standard Deviation|Mean
149697|NCT00390806|Secondary|Number of Participants Who Died or Progressed|Disease-related events were measured as the number of participants who died or progressed. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. Data were analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before an event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|mITT Population||participants|||Number
149698|NCT00390806|Secondary|Brain Symptoms|"Brain symptoms were assessed as the number of participants with neurological signs and symptoms. For brain symptom data, see the outcome measures entitled Number of participants with the indicated investigator assessment for the neurological sign and symptom of X at Baseline, Month 1, and Month 3."|Baseline, Month 1, and Month 3||||||
149699|NCT00390806|Secondary|Lesion Assessment and Measurement|"Lesions were assessed per WHO criteria. For lesion assessment data, see the outcome measure entitled Number of participants with a complete response (CR) or a partial response (PR) (central nervous system [CNS]-radiologic)."|From the time of Randomization until the time of CR or PR (up to 75 weeks)||||||
149700|NCT00390806|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range|"The worst-case change from Baseline in chemistry parameters was measured as decrease to low (DTL), change to normal or no change (CTN/NC), or increase to high (ITH). The worst-case change value could have been measured at any point during the on-therapy period. Participants are counted twice if the participant Decreased to Low and Increased to High during the on-therapy period."|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|"Modified ITT Population. Only those participants with available laboratory values (indicated by the n in the category titles) were analyzed. Different participants may have been analyzed for different parameters; therefore, the overall number of participants analyzed reflects everyone in the Modified ITT Population."||participants|||Number
149701|NCT00390806|Secondary|Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect. For a list of all SAEs and AEs, see the SAE/AE module of this results summary.|From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)|Modified ITT Population: all randomized participants who received at least one dose of randomized therapy. Participants were analyzed by the actual treatment received, even if this differed from the treatment to which they were randomized.||participants|||Number
149702|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (balance) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149703|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (gait) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149704|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (left upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149705|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of ataxia (right upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
150652|NCT00382863|Secondary|Heart Failure Death|Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure|12 months|Population is intent to treat.||participants|||Number
149706|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3|The investigator assessed participants' status of sensation and assigned each participant to one of the following categories: normal; loss of deep tendon reflexes or paresthesia, but not interfering with function (not interfering with function); objective sensory loss or paresthesia interfering with function, but not interfering with ADLs (interfering with function); sensory loss or paresthesia interfering with ADLs (intefering with ADLs); permanent sensory loss that interferes with function (permanent sensory loss).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149707|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149708|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149709|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (left upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149710|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of strength (right upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149711|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3|The investigator assessed participants' status of language (dysphasia or aphasia) and assigned each participant to one of the following categories: absent; awareness of receptive or expressive aphasia, not impairing ability to communicate (not impaired); receptive or expressive dysphasia, impairing ability to communicate (impaired); inability to communicate (unable).|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149712|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3|The investigator assessed participants' status of cranial nerves II-XII and assigned each participant to one of the following categories: normal; present, not interfering with ADLs; present, interfering with ADLs; life threatening, disabling.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149713|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for other neurological symptoms and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
149729|NCT00390780|Secondary|Susceptibility of Candida Species by Microdilution Test|minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit|Initiation of treatment to Day 17 to 22|ITT (all randomized patients who took at least 1 dose of study medication), nonresponders (participants with progression to a higher visible lesion extent score or no reduction in oral lesion extent score at the test of cure [Day 17 to 22] visit)||mcg/ml||Standard Deviation|Mean
149714|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for seizure and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
149715|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for visual problem and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
149716|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for nausea/vomiting and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
149717|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for vertigo and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
149718|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3|The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
149725|NCT00390806|Secondary|Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)|The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the time of CR or PR (up to 75 weeks)|ITT Population||participants|||Number
149719|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3|The investigator (per Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular grade at a particular time point, then no participants had an event of that grade at that time point.||participants|||Number
149720|NCT00390806|Secondary|Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3|The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma.|Baseline, Month 1, and Month 3|ITT Population. Only those participants who were assessed at the indicated time point were analyzed. If no data are presented for a particular status at a particular time point, then no participants had that status at that time point.||participants|||Number
149721|NCT00390806|Secondary|Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3|Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG).|Months 1 and 3|ITT Population. Only those participants who were assessed for the indicated sign and symptom at the indicated time point were analyzed.||participants|||Number
149722|NCT00390806|Secondary|Time to Progression (TTP) (All Sites of Disease-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population||weeks||95% Confidence Interval|Median
149723|NCT00390806|Secondary|Time to Progression (TTP) (CNS-radiologic)|TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.|From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)|ITT Population||weeks||95% Confidence Interval|Median
149724|NCT00390806|Secondary|Time to Response (TTR) (CNS-radiologic)|TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.|From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)|ITT Population. Only those participants with a CR, PR, or a missing response were assessed. TTR was analyzed with censoring for extended loss to follow-up to account for two or more missed response assessments before a TTR event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.||weeks||95% Confidence Interval|Median
149726|NCT00390806|Secondary|Six-month Survival|Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|Month 6|ITT Population||percentage of participants|||Number
149727|NCT00390806|Primary|Overall Survival|Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.|From the time of Randomization until the date of death due to any cause (up to 195 weeks)|Intent-to-Treat (ITT) Population: all randomized participants. Participants were analyzed by the treatment to which they were randomized, even if this differed from the treatment they actually received.||months||95% Confidence Interval|Median
149731|NCT00390780|Secondary|Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet|The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour|14 days|ITT (all randomized patients who took at least 1 dose of study medication)||hours||Full Range|Mean
149732|NCT00390780|Secondary|General and Local Tolerability and Oral Discomfort|Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14.|14 days|Safety Population (same as ITT population, includes all randomized patients who took at least one dose of the study medication)||participants|||Number
149733|NCT00390780|Secondary|Oral Discomfort Using Visual Analog Scale (VAS)|Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort)|14 days|Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)||units on a scale||Full Range|Mean
149734|NCT00390780|Secondary|Relapse at the Late Post-Therapy Visit (Day 35-38)|"Number of patients represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., clinical success) on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a clinical success at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under Not Analyzed-ITT."|35 to 38 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
149735|NCT00390780|Secondary|Mycological Cure at the Test of Cure Visit (Day 17-22)|"Mycological cure was defined as a patient who had no yeast isolated when oral specimens were cultured for fungi."|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
149736|NCT00390780|Secondary|Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
149737|NCT00390780|Secondary|Clinical Success at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
149738|NCT00390780|Secondary|Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
149739|NCT00390780|Secondary|Clinical Cure at Day 7 (Using Murray Scoring Scale)|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|7 days|"ITT (all randomized patients who took at least 1 dose of study medication)~PP (all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
149780|NCT00390234|Secondary|Survival (Carcinosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years|||months||95% Confidence Interval|Median
149740|NCT00390780|Primary|Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale|Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.|17 to 22 days|"Intent-to-Treat (ITT, all randomized patients who took at least 1 dose of study medication)~Per Protocol (PP, all patients in ITT without major protocol deviation, with positive fungal culture, completed at least 10 days of treatment, had main efficacy criteria at test of cure, compliant within 71.4% to 120%, and no forbidden medications taken)"||participants|||Number
149741|NCT00390689|Secondary|Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period|Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
149742|NCT00390689|Secondary|Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
149743|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
149744|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 52 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Deviation|Mean
149745|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 52 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Deviation|Mean
149746|NCT00390689|Secondary|IRLS Responder for Open-label Period|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 52|Full Analysis Set (FAS).||Percentage of patients|||Number
149747|NCT00390689|Secondary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe).|Week 52 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Deviation|Mean
149748|NCT00390689|Secondary|Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.||baseline to 6 weeks|||participants|||Number
149749|NCT00390689|Secondary|Patient Global Impression (PGI) Responder|PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.|baseline to week 6|Full Analysis Set (FAS).||Percentage of patients|||Number
149750|NCT00390689|Secondary|Clinical Global Impression Global Improvement (CGI-I) Responder|CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.|baseline to week 6|Full Analysis Set (FAS).||Percentage of patients|||Number
149751|NCT00390689|Secondary|Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks|ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)|Week 6 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Error|Least Squares Mean
149781|NCT00390234|Primary|Incidence of Disease Stabilization, as Measured by Progression-free Survival at 6 Months (Carcinosarcoma Group)||6 months|||months||95% Confidence Interval|Median
149752|NCT00390689|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks|PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).|Week 6 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Error|Least Squares Mean
149753|NCT00390689|Secondary|IRLS Responder|The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)|baseline to week 6|Full Analysis Set (FAS).||Percentage of patients|||Number
149754|NCT00390689|Primary|Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks|The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.|Week 6 - change from baseline|Full Analysis Set (FAS).||Points on a scale||Standard Error|Least Squares Mean
149755|NCT00390611|Secondary|Toxicity of Paclitaxel/Carboplatin vs. Paclitaxel/Carboplatin/Sorafenib|Number of patients experiencing treatment-related adverse events|18 months|||participants|||Number
149756|NCT00390611|Secondary|Overall Survival (OS)|Overall survival was measured from the date of study entry until the date of death|18 months|||months||95% Confidence Interval|Median
149757|NCT00390611|Secondary|Overall Response Rate (ORR)|Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease) or determined by CA-125 levels (for patients without measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions, and normalization of CA-125 for at least 4 weeks. In patients who have only elevated CA-125, the CA-125 must normalize (< 23U/mL) for more than 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. For patients with elevated CA-125 only, partial response will be defined as a > 50% decrease in the serum CA-125 level.|18 months|||participants|||Number
149758|NCT00390611|Primary|2-year Progression-free Survival|The proportion of patients with progression-free survival at 2 years. Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years|||percentage of participants|||Number
149759|NCT00390572|Primary|Sleep Quality|Changes in overall sleep quality were evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rating scale that yields a quantitative index of general sleep quality/disturbances. The PSQI is composed of 4 open-ended questions and 19 self-rated items (0-3 scale) assessing sleep quality and disturbances over a 1-month interval. The PSQI yields a global score of sleep quality ranging from 0 to 21. A score of <= 5 on the PSQI is considered normal sleep quality.|10 Months|Data from all participants were included in analyses.||units on a scale||Standard Deviation|Mean
149760|NCT00390572|Primary|Sleep Efficiency|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 Months after Baseline|Data from all participants was included.||percentage of time in bed spent sleeping||Standard Deviation|Mean
149761|NCT00390572|Secondary|Sleepiness|Changes in subjectively assessed daytime sleep propensity were measured using the Epworth Sleepiness Scale (ESS), a commonly employed in both sleep research and clinical applications. The ESS items inquire about the chance of dozing off in each 8 different situations. Responses are rated on a 4 point scale reflecting the respondents perceived likelihood of falling asleep. To quanitfy this outcome, the percentage of participants achieving normal sleep (less than 10 on ESS) was compared across arms at 10 months.|10 months|||percentage of participants|||Number
149762|NCT00390572|Primary|Diary Sleep: Total Wake Time and Total Sleep Time|Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.|10 months|||minutes||Standard Deviation|Mean
149763|NCT00390572|Primary|Provider Adherence to Sleep Specialist Recommendations|Provider outcomes included the provider’s number of participant sleep lab referrals, referrals to other specialty clinics for evaluation/treatment participant sleep problems, and presence of newly initiated sleep-focused therapies for participants. Information about these outcomes was obtained via review of provider orders and information included in notes entered into the VA’s computerized medical record system (CPRS). To quantify this outcome, the number of participants referred by providers for sleep-focused diagnostic tests and interventions was compared across arms.|10 months after baseline|Data was included for all participants.||participants|||Number
149782|NCT00390234|Secondary|Survival (Leiomyosarcoma Group)|Survival statistics will be estimated using the Kaplan-Meier method. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest where possible.|Up to 3 years|||months||95% Confidence Interval|Median
149764|NCT00390559|Primary|Subjective Effects|"The full scale name is the Urge to smoke visual analog scale (VAS). It measures self-reported urge to smoke. As with any VAS a word or phrase (in this case, Urge to Smoke is centered over a horizontal line anchored on the left by “not at all” and on the right by “extremely.” In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 (“not at all”) and the maximum score was 100 (“extremely”)."|6 hours|"Those who completed all four arms of the crossover study."||units on a scale||Standard Deviation|Mean
149765|NCT00390546|Secondary|Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin|In relation to the study drugs|12 months|||participants|||Number
149766|NCT00390546|Secondary|Number of Treated Patients Experiencing First SVT Recurrence|Infants treated with propranolol or digoxin|up to 110 days of treatment|||participants|||Number
149767|NCT00390546|Primary|Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.||6 months or until study endpoints were reached|||percentage of participants|||Number
149768|NCT00390468|Primary|8-week Freedom-From-Progression (FFP)|Simon 2 stage design for freedom from progression at 8 weeks where time-to-progression defined as time of initiation of therapy to first determination of progression of disease by clinical, radiological or serological criteria: Frequency of p-PDGFR (phosphorylated platelet-derived growth factor receptor) expression in bone marrow biopsy specimens, prostate-specific antigen (PSA) declines by 50% sustained for 4 weeks, measurable disease outcomes by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, and quantitative/qualitative toxicities assessed.|8 weeks; repeat assessments performed every 8 weeks after criteria for response first met.|Analysis was per protocol; Of 18 participants, only 15 were evaluable for efficacy.||participants|||Number
149769|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-positive Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 positive disease were analyzed.||percentage of participants||95% Confidence Interval|Number
149770|NCT00390455|Other Pre-specified|Objective Tumor Response Rate for Participants With HER2-negative Tumors|Response was defined by the RECIST. A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy, had measurable disease and HER-2 negative disease were analyzed.||percentage of participants||95% Confidence Interval|Number
149771|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-positive Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, whichever occurred first.|Up to 5 years|Participants who started protocol therapy and had HER2-positive disease were analyzed.||months||95% Confidence Interval|Median
149772|NCT00390455|Other Pre-specified|Progression-free Survival for Participants With HER2-negative Tumors|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first.|Up to 5 years|Participants who began protocol therapy with HER-2 negative tumors were analyzed.||months||95% Confidence Interval|Median
149773|NCT00390455|Secondary|Overall Survival (OS)|Overall survival was measured as the interval from study entry until death, from any cause, or last contact.|Study entry to death or last follow-up, up to 5 years|4 participants who never started protocol therapy were excluded.||months||95% Confidence Interval|Median
149774|NCT00390455|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.|Up to 5 years|Participants who started protocol therapy and had measurable disease were evaluated.||percentage of participants||95% Confidence Interval|Number
149775|NCT00390455|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).|Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years|4 participants who never received protocol therapy were excluded.||months||95% Confidence Interval|Median
149776|NCT00390416|Primary|1-year Survival||1 year|||months||95% Confidence Interval|Median
149777|NCT00390416|Secondary|Patients With Measurable Disease the Confirmed Response Rate||up to 2 years|||percentage of participants||95% Confidence Interval|Number
149778|NCT00390416|Primary|6 Month Progression Free Survival|as measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies).|6 months|||percentage of participants||95% Confidence Interval|Number
149779|NCT00390364|Primary|Response Rate: The Total Number of Participants With Progression of Disease|"To determine response rate and time to tumor progression of patients with colorectal cancer and mutations in the PI3KCA gene who are treated with RAD001. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by CT (or MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesion. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion.~The outcome measure will be the total number of subjects who show progression of disease."|1 month|||participants with progression of disease|||Number
149785|NCT00390221|Secondary|Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52|The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Responses use a 5 point Likert scale range from 1 to 5. All questions are to be answered. The total score is the sum of points for all 29 questions, with a minimum score of 29, and a maximum score of 145. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a subject's functioning.|Baseline and Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing).||units on a scale||Standard Deviation|Mean
149786|NCT00390221|Secondary|Proportion of Participants Who Relapsed at Week 52|Estimated cumulative proportion of participants relapsed at Week 52, based on the Kaplan-Meier product limit method. Only relapses confirmed by the Independent Neurology Evaluation Committee were included in the analysis.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrawal from study were censored.||proportion of participants|||Number
149787|NCT00390221|Secondary|Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss.|Week 52|Intent to treat population: all randomized subjects who received at least 1 dose of study medication (excluding 21 subjects from a single site due to a protocol violation in dosing) with a non-missing value at baseline.||lesions||95% Confidence Interval|Mean
149788|NCT00390221|Secondary|Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24|Gd-enhancing lesions are detected when Gd leaks into a perivascular space due to local breakdown of the blood-brain barrier, indicating the presence of active inflammation. For participants with missing data the last valid nonbaseline measurement was carried forward if the participant was missing only 1 or 2 consecutive postbaseline scans. Otherwise the mean based on treatment group and visit was used as the imputed value. Estimated from a negative binomial model adjusted for the baseline number of Gd-enhancing lesions.|Week 8 through Week 24|Magnetic Resonance Imaging (MRI) Intensive Population: a protocol-defined subset of participants consisting of the first 307 participants enrolled in the study with non-missing baseline values.||lesions||95% Confidence Interval|Mean
149789|NCT00390221|Primary|Adjusted Annualized Relapse Rate Between Baseline and Week 52|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.|Baseline through Week 52|Intent to treat population: all randomized participants who received at least 1 dose of study medication (excluding 21 participants from a single site due to a protocol violation in dosing).||relapses per person-years||95% Confidence Interval|Number
149790|NCT00390182|Other Pre-specified|Time of Advanced/Recurrent Disease Without Distant Metastases.|Locally advanced/recurrent disease without distant metastases.|Participants were followed for an average of 8 years|||months||95% Confidence Interval|Median
149791|NCT00390182|Other Pre-specified|Percentage of Participants With Distant Mestastases - Liver|Patients with distant mestastases to the liver|Participants were followed for an average of 8 years|||percentage of participants||95% Confidence Interval|Number
149792|NCT00390182|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 weeks|||participants|||Number
149793|NCT00389974|Primary|Objective Response Rate (PR or CR)|It is defined as per the Response Evaluation Criteria In Solid Tumors criteria for at least 4 weeks. The 95% confidence interval for response rate will be calculated.|Up to 2 years|All patients evaluable for response||percentage of evalubale patients||95% Confidence Interval|Number
149794|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.|"Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).~Note: Influenza vaccine-primed group did not receive vaccination 2"|0 to 3 days post-vaccination 2|"Safety analysis was on all enrolled and vaccinated participants, intend to treat population.~Influenza vaccine-primed group did not received vaccination 2"||Participants|||Number
149795|NCT00389857|Other Pre-specified|Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.|Solicited injection site reactions: Erythema, swelling, tenderness for infants/toddlers, and pain for children Solicited systemic reactions: For infants/toddler: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, vomiting; For children: fever (temperature), headache, malaise, myalgia).|0 to 3 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population||Participants|||Number
149796|NCT00389857|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination|"GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation.~Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)"|14 days post-vaccination|Geometric mean titers were evaluated in the per-protocol population.||Titer||95% Confidence Interval|Geometric Mean
149797|NCT00389831|Primary|Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.|The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements would result in a score of 0 PLM per hour. Outcome is the average movements per hour in the 4 hour post-dose period per subject.|4 hours post-treatment period at each treatment day|Full Analysis Set||PLM per hour||Standard Deviation|Mean
149798|NCT00389831|Primary|Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo|Subjects rate the severity of the RLS symptoms at the start of each pre dose and post dose Suggested Immobilization Test (SIT-0 to SIT-6) and every 5min during each SIT, using a numeric symptoms severity scale, where 0=not severe and 10=very severe.|4 hours post-treatment period at each treatment day|Full Analysis Set||score on a scale||Standard Deviation|Mean
149799|NCT00389818|Secondary|Event-free Survival at 1 Year||1 year post-treatment||||||
149800|NCT00389818|Secondary|Mortality and Cause of Death||At any time through the third year after treatment discontinuation||||||
149801|NCT00389818|Secondary|Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
149802|NCT00389818|Secondary|Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue||Baseline, after cycles 4 and 6, 1 month after treatment discontinuation||||||
149803|NCT00389818|Secondary|Relationship Between MDR-1 Expression and Response to Treatment||Baseline||||||
149804|NCT00389818|Primary|Rate of Bacterial, Fungal, and Opportunistic Infections||After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
149805|NCT00389818|Primary|Median Survival Time||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
149806|NCT00389818|Primary|Duration of Response||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation||||||
149807|NCT00389818|Primary|Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .||After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation|||proportion of patients||95% Confidence Interval|Number
149808|NCT00389597|Primary|Composite Definition of Study Success|"An individual subject in either treatment group was considered a success if the following criteria were met at 24 months:~Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of >= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of <30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities.~No study failures due to secondary surgical interventions at the index level~Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC"|2 Years|includes study failures, per protocol, that are carried forward for overall success||percentage of subjects analyzed|||Number
149809|NCT00389532|Primary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination|GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.|21 days post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population||Titer||95% Confidence Interval|Geometric Mean
149810|NCT00389532|Primary|Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination|Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)|0-3 days post-vaccination|Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.||Percentage of Participants|||Number
149811|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)|Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF||mL/min per 1.73 m2||Standard Deviation|Mean
149812|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Potassium|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF||mg/dL||Standard Deviation|Mean
149813|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Serum Creatinine|Value at end of treatment (up to 4 weeks) minus value at baseline|Baseline up to 4 weeks|Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF||mg/dL||Standard Deviation|Mean
149814|NCT00389519|Secondary|Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)||mm Hg||Standard Deviation|Mean
149815|NCT00389519|Primary|Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure|Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo|Baseline to 4 weeks|Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)||mm Hg||Standard Deviation|Mean
149816|NCT00389493|Secondary|Brown Assessment of Beliefs (BABS)|"Scale ranges from 0 to 24 where 0 is beliefs are false and 24 is convinced beliefs = reality"|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
149817|NCT00389493|Secondary|Hamilton Depression Rating Scale (Ham-D)|Ham-D ranges from 0=no symptoms to 52 with higher numbers indicating more severe depression|Week 0 and Week 8|||units on a scale||Standard Deviation|Mean
149822|NCT00389467|Secondary|Symptomatic Hemorrhagic Transformation|"Symptomatic intracranial hemorrhage is defined as 4 point neurologic worsening on the National Institutes of Health Stroke Scale (NIHSS) score associated with parenchymal hematoma type 2 (PH-2*), remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage on imaging. The NIHSS is a scale measuring specific neurologic deficits caused by a stroke with scores ranging from 0 to 42, and higher scores indicating more severe neurologic deficits.~*from the modified European Cooperative Acute Stroke Study (ECASS) II criteria"|from baseline to day 7|||participants|||Number
149823|NCT00389467|Primary|The Modified Rankin Scale Score|"Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death.~0 - No symptoms.~1 - No significant disability. Able to carry out all usual activities, despite some symptoms.~2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~3 - Moderate disability. Requires some help, but able to walk unassisted.~4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~6 - Dead."|at 90 days post-stroke|||units on a scale||95% Confidence Interval|Mean
149824|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life). Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.||units on a scale||Standard Deviation|Mean
149825|NCT00389441|Secondary|Change From Baseline in MD Anderson Symptom Assessment Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|Baseline, Cycle 1 Day 15 (C1D15), C2D1, C2D15, thereafter D1 of each cycle up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point.||units on a scale||Standard Deviation|Mean
149826|NCT00389441|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline to death due to any cause or at least 2 year after the first dose for the last participant|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.||weeks||95% Confidence Interval|Median
149827|NCT00389441|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||weeks||95% Confidence Interval|Median
149828|NCT00389441|Secondary|Progression Free Survival (PFS)|PFS: Time in weeks from the start of study treatment to first documentation of objective disease progression or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study treatment plus 1) divided by 7. Progression is defined using RECIST, as >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since start of study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|ITT population included all participants who were enrolled in the study and received at least 1 dose of study treatment.||weeks||95% Confidence Interval|Median
149829|NCT00389441|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST). CR: disappearance of all target/non-target lesions and no appearance of new lesions. PR: at least (>=)30 percent(%) decrease in sum of the longest dimensions (LDs) of the target lesions (taking as a reference the baseline sum), without progression of non-target lesions and no appearance of new lesions. Confirmed responses: those persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline until disease progression or initiation of antitumor therapy or death due to any cause, assessed every 8 weeks up to 28 days after last dose (follow-up)|Intent-to-Treat (ITT) population included all participants who were enrolled in the study and received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
149830|NCT00389324|Primary|Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)|Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).|IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 days|A total of 32 subjects in the IV phase and 26 subjects in the SC phase had sufficient plasma concentration of total IgG vs. time profiles (AUC) for assessment of steady-state PK parameters.||mg*hr/ml||Standard Deviation|Least Squares Mean
149831|NCT00389207|Secondary|Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144|Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||ratio||Standard Deviation|Mean
149832|NCT00389207|Secondary|Change of Total Triglycerides From Baseline to Week 48, 96, 144|Change of total triglycerides from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||mg/dL||Standard Deviation|Mean
149833|NCT00389207|Secondary|Change of hsCRP From Baseline to Week 48, 96, 144|Change of hsCRP from baseline to week 48, 96, 144|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||mg/L||Standard Deviation|Mean
149834|NCT00389207|Secondary|Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144|Changes frombaseline apolipoprotein A1 & B|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||g/L||Standard Deviation|Mean
149835|NCT00389207|Secondary|Change of Cholesterol Values From Baseline to Week 48, 96, 144|Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL|baseline to week 48, 96, 144|FAS, where only patients with corresponding laboratory values for the considered time point are considered||mg/dL||Standard Deviation|Mean
149836|NCT00389207|Secondary|Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity|Proportion of Patients reporting CNS (central nervous system) side effects of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
149837|NCT00389207|Secondary|Proportion of Patients Reporting Hepatic Events of Any Severity|Proportion of Patients reporting hepatic events of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
149838|NCT00389207|Secondary|Proportion of Patients Reporting Rash of Any Severity|Proportion of Patients reporting rash of any severity|week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
149839|NCT00389207|Secondary|Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities||week 148|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
149840|NCT00389207|Secondary|Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144|Calculations based on the MDRD algorithm.|From baseline to Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||mL/min/1.73 m^2||Standard Deviation|Mean
149841|NCT00389207|Secondary|Time to Treatment Failure|Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||weeks||Inter-Quartile Range|Median
149842|NCT00389207|Secondary|Time to Loss of Virologic Response (Rebound)|Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.|Baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||weeks||Inter-Quartile Range|Median
149843|NCT00389207|Secondary|Time to Treatment Response (First Confirmed VL<50 Copies/mL)|Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response|baseline to week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||weeks||Inter-Quartile Range|Median
149844|NCT00389207|Secondary|Proportion of Patients With Virologic Failure at Week 48, 96, 144||at Week 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||participants|||Number
149845|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
149846|NCT00389207|Secondary|Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144|The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)|at Week 24, 48, 96, 144|Full Analysis Set (FAS) defined as all randomized and treated patients.||participants|||Number
149847|NCT00389207|Secondary|Treatment Response at Week 144|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.|From baseline to Week 144|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories.||participants|||Number
149848|NCT00389207|Secondary|Treatment Response at Week 96|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.|From baseline to Week 96|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||participants|||Number
149849|NCT00389207|Secondary|Glycaemic Abnormalities|Number of patients with AE elevated serum glucose|From baseline to Week 144|FAS||Patients|||Number
149850|NCT00389207|Secondary|Serum Lipid Abnormalities|Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)|From baseline to Week 144|FAS||patients|||Number
149851|NCT00389207|Secondary|Lipodystrophy|Number of patients with AE lipodystrophy|From baseline to Week 144|FAS||Patients|||Number
153041|NCT00360334|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure from baseline to endpoint|26 weeks|Full Analysis Set||mmHg||Standard Error|Least Squares Mean
149854|NCT00389207|Secondary|Genotypic Resistance Associated With Virologic Failure|Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.|From baseline to Week 48|All patients with virologic failure assessed for genotypic resistance||Number of substitutions|||Number
149855|NCT00389207|Secondary|Non-scheduled Physician Visits|Cost effectiveness assessment by number of patients with non-scheduled physician visits|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing||patients|||Number
149856|NCT00389207|Secondary|Number of Patients Hospitalized|Cost effectiveness assessment by number of patients hospitalized|From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT|FAS with varying numbers missing||Patients|||Number
149857|NCT00389207|Secondary|Change in Physical Health Summary (PHS) Score From Baseline|QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing||Units on a scale||Standard Deviation|Mean
149858|NCT00389207|Secondary|Change in Mental Health Summary (MHS) Score From Baseline|Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing||Units on a scale||Standard Deviation|Mean
149859|NCT00389207|Secondary|Change in Framingham Score From Baseline|Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.|From baseline to Weeks 48, 96 and 144/EOT|FAS with varying numbers missing||Units on a scale||Standard Deviation|Mean
149860|NCT00389207|Secondary|Change in CD4+ Count From Baseline|Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit||cells/mm^3||Standard Deviation|Mean
149861|NCT00389207|Secondary|Proportion of Patients With VL < 400 Copies/ml|VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit||Proportion of patients|||Number
149862|NCT00389207|Secondary|Proportion of Patients With VL < 50 Copies/ml|VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient|From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT|FAS with varying numbers missing or not on treatment per visit||Proportion of patients|||Number
149863|NCT00389207|Secondary|Treatment Response at Week 48 (TLOVR Algorithm)|Treatment response is defined as a VL <50 copies/mL measured at two consecutive visits up to Week 48 and without subsequent rebound or change of ARV therapy up to Week 48, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.|From baseline to Week 48|FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories||Patients|||Number
149864|NCT00389207|Primary|Treatment Response at Week 48|Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.|From baseline to Week 48|Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories||Patients|||Number
149865|NCT00389168|Secondary|Effects on Carotid Artery Wall Thickness|Changes in common carotid artery intima-media thickness, assessed by ultrasonography.|Baseline to 48 weeks|||mm||Standard Deviation|Mean
149866|NCT00389168|Secondary|Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System|Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability.|Baseline to 48 weeks|||pmol/L||95% Confidence Interval|Mean
149867|NCT00389168|Secondary|Blood Pressure|Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks|Baseline to 48 weeks|||mm Hg||95% Confidence Interval|Mean
149868|NCT00389168|Secondary|Left Ventricular Diastolic Function Assessed by the E/A Ratio|Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points.|Baseline to 48 weeks|||ratio||Standard Deviation|Mean
149869|NCT00389168|Primary|Changes in Left Ventricular Mass Index|Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m^2).|Baseline and 48 weeks|Data on echocardiography is not always available at all time points and for all participants. This is reflected by the number of observations, which sometimes are less than the number of participants.||g/m^2||95% Confidence Interval|Mean
149870|NCT00389168|Secondary|Number of Participants With Serious Adverse Events|Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication.|Treatment period was baseline to 48 weeks|||Participants|||Number
149871|NCT00389064|Secondary|Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)|Number of patients have adverse events associated with EPS|From start of the study teatment to last dose plus 30 days|Safety population||Patients|||Number
149872|NCT00389064|Secondary|Safety and Well Tolerated as Measured in Adverse Event|Number of patients have at least one adverse event|From the start of treatment to last dose plus 30 days|Safety population||Participants|||Number
149873|NCT00389064|Secondary|Change in the Visual Analogue Scale (VAS) Measuring Pain|Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.||mm||Standard Deviation|Least Squares Mean
149874|NCT00389064|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization|Randomization to week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
149875|NCT00389064|Secondary|Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission|"HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:~If HAM-A total score≤7, THEN indicator=1~If HAM-A total score >7, THEN indicator=0"|Week 9|Modified Intent to Treat (MITT) population.||Number of participants.|||Number
149876|NCT00389064|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Response.|HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.|Week 9|||Number of participants.|||Number
149877|NCT00389064|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
149878|NCT00389064|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
149879|NCT00389064|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
149880|NCT00389064|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.~Change : percentage at week 9 minus percentage at randomization"|Randomization to Week 9|In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo).||Percentage of Maximum Total Score||Standard Deviation|Least Squares Mean
149881|NCT00389064|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization|Randomization to Week 9|Modified Intent to Treat (MITT) population.||units on scale||Standard Deviation|Least Squares Mean
149882|NCT00388973|Secondary|Tolerability as Measured by Adverse Event Withdrawals During Treatment||Baseline to Week 9|All Randomized patients.||Participants|||Number
149883|NCT00388973|Secondary|Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)|The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Full Range|Median
149884|NCT00388973|Secondary|Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10|The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Full Range|Median
149885|NCT00388973|Secondary|Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Standard Deviation|Least Squares Mean
149886|NCT00388973|Secondary|Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)|Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on a scale||Standard Deviation|Least Squares Mean
149903|NCT00388583|Primary|Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40|Day 28 post-vaccination|Immunogenicity determination was in all per protocol population||Participants|||Number
154835|NCT00338104|Primary|Percentage of Blood Glucose Values Between 80 - 140|Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL|First 24 hours after conversion|||percentage of blood glucose values|||Number
149887|NCT00388973|Secondary|Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)|Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study. Patients not on medication at baseline would have left the item blank and therefore no change from baseline could be calculated||units on scale||Full Range|Median
149888|NCT00388973|Secondary|Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)|Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||Percentage of Improvement||Standard Deviation|Least Squares Mean
149889|NCT00388973|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.|MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.|Baseline to Week 9|All randomized patients who took at least one dose of study medication and had at least one post baseline assessment, with last observation carried forward to week 9 for patients who did not complete the study.||units on scale||Standard Deviation|Least Squares Mean
149890|NCT00388947|Secondary|Prolapse Efficacy Success Rate|Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used.|24 months|Patients returning for a visit between 19-24 months post-procedure.||percentage of participants||95% Confidence Interval|Number
149891|NCT00388947|Primary|Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device||up to 2-years post-implant|All patients that met the inclusion/exclusion criteria.||participants|||Number
149892|NCT00388804|Primary|Prostate Specific Antigen (PSA) Failures|Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.|3 months up to 2 years|One person was not treated and therefore excluded from the analysis.||participants|||Number
149893|NCT00388037|Primary|Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Partial response is defined as a 30% decrease in the sum of the longest diameters of the target lesion maintained for at least 4 weeks; complete response is defined as complete disappearance of disease and cancer related symptoms maintained for at least 4 weeks. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.|Up to 3 years|All response evaluable patients||percentage of evalubale patients||95% Confidence Interval|Number
149894|NCT00387153|Secondary|Antiproliferative Activity|Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.|Every 42 days||||||
149895|NCT00387153|Primary|Pharmacokinetics|Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.|First 5 days of treatment (Cycle 1)||||||
149896|NCT00387153|Primary|Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4.|"Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia.~An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation."|First 21 days on treatment (Cycle 1)|A total of 8 subjects were enrolled in the study. Statistical analyses were intended to be descriptive since the goal for the study was to determine the maximum tolerated dose and general safety and tolerability of MPC-2130.||Participants|||Number
149897|NCT00388726|Secondary|Safety Parameters: Adverse Events (AEs), Laboratory Parameters, Concomitant Medication, Electrocardiograms (ECGs), and Study Drug Exposure.||AEs and conmeds – until study termination; lab tests – Day 1 and weekly until study termination; ECGs - Day 1 and at study termination.||||||
149898|NCT00388726|Secondary|Duration of Response.|As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.|From first documented CR or PR until disease progression or death.|Response Evaluable Population||Days||Full Range|Median
149899|NCT00388726|Secondary|Best Overall Response|Measured by RECIST criteria and defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.|Response Evaluable Population||Percent of Participants|||Number
149900|NCT00388726|Secondary|Progression-Free Survival.|Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.|Until disease progression or death.|Intent to Treat||Days||Full Range|Median
149901|NCT00388726|Primary|Overall Survival|Defined as the time from the date of randomization until the date of death from any cause.|From date of randomization until death from any cause|Intent to Treat||Days||Full Range|Median
149902|NCT00388583|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus.~Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia."|Day 0 up to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population||Participants|||Number
149904|NCT00388583|Secondary|Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.|The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre- and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population||Titers||95% Confidence Interval|Geometric Mean
149905|NCT00388583|Primary|Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.|The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.|Pre-vaccination and Day 28 post-vaccination|Immunogenicity determination was in all per protocol population||Participants|||Number
149906|NCT00388505|Secondary|Hospitalization Due to Respiratory Events During the Study|The average number of days patients were hospitalized due to respiratory events during the course of the study.|25 Weeks|Patients in the intent-to-treat population who were hospitalized due to respiratory events.||days||Standard Deviation|Mean
149907|NCT00388505|Secondary|Antipseudomonal Antibiotic Usage During the Study|The average number of days patients required antipseudomonal antibiotics during the course of the study.|25 Weeks|Patients in the intent-to-treat population who required antipseudomonal antibiotics.||days||Standard Deviation|Mean
149908|NCT00388505|Secondary|Change From Baseline in Tobramycin Minimum Inhibitory Concentration|The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.||μg/mL||Standard Deviation|Mean
149909|NCT00388505|Secondary|Change From Baseline in Pseudomonas Aeruginosa Sputum Density|Three Pseudomonas aeruginosa biotypes were assessed in patient’s sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.||log10 Colony forming units/g||Standard Deviation|Mean
149910|NCT00388505|Secondary|Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication|Patient’s self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain.|Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).|Intent-to-treat population for whom data were available.||Scores on a scale||Standard Deviation|Mean
149911|NCT00388505|Secondary|Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1)|"Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.~Relative change = 100 * ((Day 28 of Cycle 3 value – Baseline value)/ Baseline value)."|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)|Intent to treat population for patients with available data. For Final Visit, the last available post-baseline measurement is reported.||percent of predicted||Standard Deviation|Mean
149912|NCT00388505|Secondary|Percentage of Participants With a Decrease From Baseline in Auditory Acuity|Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.|Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)|Audiology subpopulation||percentage of participants|||Number
149913|NCT00388505|Secondary|Serum Tobramycin Concentrations|Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).|Weeks 1, 5, 17 and 21|Pharmacokinetic subpopulation||μg/mL||Standard Deviation|Mean
149914|NCT00388505|Primary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.|25 weeks|All Randomized Safety population.||participants|||Number
149915|NCT00388154|Primary|Overall Objective Response Rate (CR + PR)|Objective response (OR) defined as percentage of participants with RECIST Complete Response (CR) and Partial Response (PR), defined as CR: Disappearance all target and non-target lesions, no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Normalization of CA-125, if elevated at baseline, is required; PR: 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD, no unequivocal progression of non-target lesions; no new lesions documented by 2 disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical examination, which is not radiographically measurable, a 50% decrease in the LD is required. 21-day cycle assessments or until either disease progression or adverse effects prohibit further treatment.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.||percentage of participants|||Number
150698|NCT00382109|Secondary|Estimated Transplant Related Mortality Percentage|Death in a patient who had not relapsed after transplant is defined as transplant-related mortality event.|100 days|2 ineligible patients on experimental arm excluded from analysis.||percentage of participants||95% Confidence Interval|Number
149916|NCT00388154|Primary|Participant Responses|Response Evaluation Criteria In Solid Tumors (RECIST): Complete Response (CR): disappearance all target & nontarget lesions, absence new lesions, documented by 2 disease assessments 4 weeks apart; Partial response (PR): 30% decrease in sum longest diameter (LD) all measurable target lesions (baseline sum LDs as reference) & absence of progression of nontarget lesions or development of new, documented by 2 disease assessments 4 weeks apart. When only target lesion solitary pelvic mass measurable by physical examination but not radiography, a 50% decrease in LD required to be PR; Progressive disease (PD): 20% increase in sum LDs of target lesions (reference smallest sum of LDs at any assessment) or appearance of new lesions within 9 weeks of study entry, and unequivocal progression of existing nontarget lesions, other than pleural effusions without cytological proof of neoplastic origin within 9 weeks of enrollment; Stable disease (SD): any condition not meeting above CR, PR, or PD.|Responses required confirmation by imaging after 4-week+ interval following 3 week (21 day) therapy course.|Participants who received one or more course(s) of chemotherapy and survived at least 4 weeks were considered evaluable for response; One participant was not evaluable.||participants|||Number
149917|NCT00387959|Primary|Survival at 1 Year After Transplantation|The number of patients survival status 1 year after transplantation|1 Year after transplant|||participants|||Number
149918|NCT00387894|Secondary|Duration of Progress-free Survival (PFS)|Patients with stable or responding disease will continue treatment until tumor progression is determined|Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)|||participants|||Number
149919|NCT00387894|Primary|Disease Response Measured Objectively by MRI of Brain|Lack of disease progression indicates response to treatment|Every 8 weeks or as indicated|5 participants evaluable while receiving study treatment||participants|||Number
149920|NCT00387881|Secondary|Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score|Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.|0 - 24 hours after treatment|ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188||Score in scale||Standard Error|Mean
149921|NCT00387881|Secondary|Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment|Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)|2 and 4 hours after treatment|ITT Population||Participants|||Number
149922|NCT00387881|Secondary|Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours|Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)|1-2 and 2-4 hours after treatment|ITT Population||Participants|||Number
149923|NCT00387881|Secondary|Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment|Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)|1-2, and 2- 4 hours after treatment|ITT Population||Participants|||Number
149924|NCT00387881|Secondary|Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment|Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.|0 - 24 hours after treatment|ITT Population||Participants|||Number
149925|NCT00387881|Secondary|Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment|Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.|0.5, 1, 2, and 4 hours after treatment|ITT Population||Participants|||Number
149926|NCT00387881|Secondary|Sustained Headache Relief 2-24 Hours After Treatment|Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.|2-24 hours after treatment|ITT Population||Participants|||Number
149927|NCT00387881|Secondary|Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment|Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.|0.5, 1, and 4 hours after Treatment|ITT Population||Participants|||Number
149928|NCT00387881|Primary|Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.|Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.|2 hours through 24 hours after Treatment|The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.||Participants|||Number
149929|NCT00387829|Secondary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|12 months|Data reported for patients evaluable at 12 months.||Outcome scores||Standard Error|Least Squares Mean
150074|NCT00386360|Primary|Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Primary Efficacy Population - all patients in ITT population who had no major protocol violations and had an evaluable distal radius BV/TV (trabecular bone volume to tissue volume) at baseline and Month 12.||Percent Change||95% Confidence Interval|Least Squares Mean
149930|NCT00387829|Primary|Radiological, Pain, and Functional Outcome Assessments|"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject’s pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100."|6 months|Data reported for patients evaluable at 6 months.||Outcome scores||Standard Error|Least Squares Mean
149931|NCT00387790|Secondary|Occurrence of Serious Toxicity|Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.|Up to 1 year after enrollment||||||
149932|NCT00387790|Secondary|One Year Overall Survival||Time to death from any cause, assessed up to 1 year after enrollment||||||
149933|NCT00387790|Primary|One Year Event-free Survival (EFS)||Time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, assessed up to 1 year after enrollment.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome. The 2 patients who are ineligible were excluded from the Outcome Measure analysis.||participants|||Number
149934|NCT00387764|Secondary|Percentage of Participants Who Survived Until Month 12|For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to Month 12|ATS Population||Percentage of participants|||Number
149935|NCT00387764|Secondary|Overall Survival (OS)|OS is defined as the interval between the date of the first dose of study medication to the date of death due to any cause. For participants who did not die, time to death was censored at the time of last contact. The last date of contact was defined as the maximum date of any visit date or the survival follow-up date.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population||months||95% Confidence Interval|Median
149936|NCT00387764|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of the first dose of study medication and the date of disease progression as defined by the investigator or death due to any cause. RECIST was used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Participants who did not have disease progression or did not die were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to 3.460 years)|ATS Population||months||95% Confidence Interval|Median
149937|NCT00387764|Secondary|Number of Participants With the Indicated Best Overall Response|The best overall response is defined as the best response recorded from the start of the treatment until disease progression (PD)/recurrence. Per RECIST: CR, the disappearance of all target and non-target lesions; PR, at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; SD, neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s); PD, at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum of the LD recorded since the treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Unknown/not evaluable is used for those participants who cannot be classified as achieving CR, PR, SD, or PD.|From the Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population||participants|||Number
149938|NCT00387764|Secondary|Number of Participants With a Response of Confirmed CR+PR+6-month Stable Disease (SD)|The number of participants who achieved either a CR, a PR, or a best response of SD that occurred at least 6 months after screening per RECIST criteria was assessed. CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD; and SD is defined as neither sufficient shrinkage in target lesions to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and the persistence of one or more non-target lesion(s), as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response. A confirmed response of SD required that the SD assessment occurred no earlier than 12 weeks after the screening scans.|From the Baseline to Week 24/investigational product discontinuation (up to 1.65 years)|ATS Population. An analysis was performed on 71 participants.||participants|||Number
149939|NCT00387764|Secondary|Number of Participants With a Complete Response (CR) or Partial Response (PR)|Overall tumor response is defined as the number of participants achieving either a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). RECIST guidelines were used to evaluate the measurability of tumor lesions, to determine target and non-target lesions at Baseline, and to evaluate tumor response or disease progression after study start. CR is defined as the disappearance of all target and non-target lesions, and PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as a reference the Baseline sum LD, as assessed by the investigator. Confirmation of a CR/PR required a subsequent assessment of the same response or better at least 28 days after the original response.|From Baseline to Week 24/investigational product discontinuation (up to 3.460 years)|ATS Population||participants|||Number
150174|NCT00386100|Secondary|Number of Participants at Final Dose Level||Baseline to Week 80 or withdrawal|Safety population. This population consisted of all participants who were randomized and received at least one dose of the study medication.||participants|||Number
149940|NCT00387764|Primary|Number of Participants With a Change From Baseline to the Indicated Worst-case Post-Baseline Bazett's Heart Rate-corrected QT Interval (QTc) Value|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. A lengthened QT interval can be a biomarker for ventricular tachyarrhythmias. The QT interval corrected for heart rate using Bazett’s formula (QTcB) was calculated; the faster the heart rate, the shorter the QT interval. Electrocardiogram values (Bazett’s QTc value) were summarized using the following reference ranges: <450, 450 to 479, 480 to 499, 500 to 549, and >550 milliseconds.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed; 3 participants did not have post-Baseline results.||participants|||Number
149941|NCT00387764|Primary|Number of Participants With the Indicated Shift in Heart Rate From Baseline at Any Time Post-Baseline|Heart rate is the measure of heart beats per minute (bpm). The number of participants with a post-Baseline shift from Baseline in heart rate of <44 bpm, 44 to 100 bpm, 101 to 120 bpm, and >120 bpm was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed.||participants|||Number
149942|NCT00387764|Primary|Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline|Blood pressure measurements included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). The number of participants with a post-Baseline shift from Baseline in blood pressure (<90 mmHg, 90 to 139 mmHg, 140 to 169 mmHg, >=170 mmHg) was assessed.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population||participants|||Number
149943|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Grade Increase From Baseline for the Indicated Hematology Parameters at Any Time Post-Baseline|Hematology parameters were summarized according to NIH CTCAE, version 4.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Hematology parameters included: hemoglobin (anemia), lymphocytes (lymphocytopenia), neutrophils (neutropenia), platelets (thrombocytopenia), white blood cells (WBC [leukopenia]), and prothrombin time international normalized ratio (PT [INR]). Participants with missing Baseline grades are assumed to have a Baseline grade of 0.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.||participants|||Number
149944|NCT00387764|Primary|Number of Participants With the Indicated Worst-case Toxicity Grade Increase From Baseline for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline|Clinical chemistry parameters were summarized according to NCI CTCAE, version 4.0: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for only those parameters for which an increase from Baseline occurred. Clinical chemistry parameters included: alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin (TB), calcium (hypercalcemia and hypocalcemia), creatinine, glucose (hyperglycemia and hypoglycemia), potassium (hyperkalemia and hypokalemia), magnesium (hypermagnesemia and hypomagnesemia), sodium (hypernatremia and hyponatremia), and phosphate.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ATS Population.||participants|||Number
149945|NCT00387764|Primary|Median Time on Investigational Product|The time on investigational product (including dose interruptions) is defined as the difference between the date of the last dose of investigational product and the date of the first dose of investigational product plus one.|From Baseline to investigational product discontinuation (up to 6.230 years)|ATS Population||Months||Inter-Quartile Range|Median
149946|NCT00387764|Primary|Number of Participants With Adverse Events Related to Investigational Product|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The investigator assessed relatedness between the AE and the investigational product.|From Baseline to Follow-up (up to 6.230 years)|ATS Population||participants|||Number
149947|NCT00387764|Primary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Severity, Per National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the NCI CTCAE, version 3.0: Grade 1, mild; Grade 2, moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling; Grade 5, death.|From Baseline to Follow-up (up to 6.230 years)|ATP Population||participants|||Number
149948|NCT00387764|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations.|From Baseline to Follow-up (up to 6.230 years)|All Treated Participants (ATP) Population: all enrolled participants who received at least one dose of open-label investigational product||participants|||Number
149949|NCT00387751|Secondary|Survival|Determined by time to progression, progression-free suvival, and overall survival.|6 months||||||
149950|NCT00387751|Secondary|Safety and Tolerability|Safety and tolerability of treatment, in terms of toxicity profile and incidence and rating of toxicity, according to NCI CTCAE v3.0 criteria.|6 months||||||
149951|NCT00387751|Primary|Response|"Clinical biologic activity of treatment, defined as the sum of complete response, partial response, and prolonged stable disease for ≥ 16 weeks, upon treatment with the combination of sorafenib and bevacizumab, in patients with advanced metastatic melanoma previously treated with immunotherapy or in previously untreated patients who are not appropriate candidates to receive IL-2-based treatment.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started of the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|4 months|||participants|||Number
149952|NCT00387725|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Dose 1 up to 1 month after Dose 3|||percentage of participants|||Number
149953|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3||1 month after Dose 3|||percentage of participants|||Number
149954|NCT00387725|Primary|Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2||1 month after Dose 2|||percentage of participants|||Number
149955|NCT00387647|Secondary|Number of Participants With Adverse Events|Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0|48 months|All participants||participants|||Number
149956|NCT00387647|Secondary|Overall Survival (OS)|The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.|48 months|All participants||months||95% Confidence Interval|Median
149957|NCT00387647|Primary|Rate of Disease Free Survival at One Year|The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with >5% blasts or the presence of Auer rods.|1 year|All participants||percentage of participants|||Number
149958|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||pmol/min||Standard Deviation|Mean
149959|NCT00387621|Primary|Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV)|Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||uEq/min||Standard Deviation|Mean
149960|NCT00387621|Primary|Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||pmol/min||Standard Deviation|Mean
149961|NCT00387621|Primary|Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV)|Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.|Baseline, 30 min, 60 min|||uEq/min||Standard Deviation|Mean
149962|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 60 min on nesiritide treatment minus value of cGMP at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes|||pmol/min||Standard Error|Mean
149963|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of cGMP at 30 min on nesiritide treatment minus value of cGMP at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)||pmol/min||Standard Error|Mean
149964|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 60 min on nesiritide treatment minus value of natriuresis at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|60 minutes|intention to treat (ITT)||mEq/min||Standard Error|Mean
149965|NCT00387621|Secondary|Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment|Value of natriuresis at 30 min on nesiritide treatment minus value of natriuresis at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.|30 minutes|intention to treat (ITT)||mEq/min||Standard Error|Mean
149966|NCT00387621|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline|baseline and 60 minutes|intention to treat (ITT)||pmol/min||Standard Error|Mean
149967|NCT00387621|Primary|Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment|Value at 60 minutes minus value at baseline.|baseline and 60 minutes|per protocol||mEq/min||Standard Error|Mean
150006|NCT00387088|Secondary|Time to First Hospitalisation for COPD Exacerbation|Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||Days||95% Confidence Interval|Median
149968|NCT00387426|Primary|Number of Participants With Objective Clinical Response to Sunitinib Therapy|Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).|After two 6-week treatment courses (12 weeks)|All participants assessed for response.||participants|||Number
149969|NCT00387348|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|Participants who had at least 1 follow up HAM-D assessment were included. Two participants died, one without a follow up assessment and one with a HAM-D at 2 weeks. For the participant who had the HAM-D at 2 weeks and then died, the last endpoint was carried forward.||Change in HAM-D scores||Standard Deviation|Mean
149970|NCT00387348|Secondary|Side Effect Burden|Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.|4 weeks|Participants who completed the 4 week assessment were analyzed||units on a scale||Standard Deviation|Mean
149971|NCT00387348|Primary|Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder|Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.|4 weeks|The efficacy analysis was intent to treat and all randomized participants were analyzed||number of participants with response|||Number
149972|NCT00387335|Secondary|Overall Survival|Time from start of treatment until death from any cause.|Up to two years|||weeks||Full Range|Median
149973|NCT00387335|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|||weeks||Full Range|Median
149974|NCT00387335|Primary|Feasibility of Treatment|Ability to remain on treatment without dose reduction|While patient remains on treatment, up to 30 weeks|||percentage of participants||95% Confidence Interval|Number
149975|NCT00387335|Primary|Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|While patient remains on treatment, up to 30 weeks|||percentage of participants||95% Confidence Interval|Number
149976|NCT00387127|Other Pre-specified|Number of Participants Classified as Responders, as Per Volumetric Tumor Response|No analysis was not performed.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population. A formal analysis of this outcome measure was never performed; thus data are not available and cannot be reported.|||||
149977|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissues: Sensitivity Analysis - 0, 1, 2 Versus 3|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.||Participants|||Number
149978|NCT00387127|Secondary|Number of Participants Positive and Negative for Biomarker HER1/ErbB1 Categorized in the Indicated Independent Review Panel-assessed Tumor Responses by Expression of Biomarkers From Tumor Tissue: Sensitivity Analysis - 0 Versus (1, 2, 3)|Tumor tissue (fresh or archived) was sent to a central laboratory for biomarker HER1/ErbB1 and tumor genetics analysis up to 1 week after randomization. Per RECIST: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. 0=negative; 1, 2, 3=positive (increasing level of biomarker expression).|From the date of randomization until 6 months post chemoradiation treatment, assessed for up to 24 weeks|ITT Population. Participants assessed for HER1/ ErbB1 expression were analyzed.||Participants|||Number
149979|NCT00387127|Secondary|Number of Participants Negative and Positive for Human Papilloma Virus (HPV) Infection, as Determined From Tumor Samples|"Analysis was performed for HPV infection analysis from the tumor biopsy samples obtained during the Screening period. p16 was used as a marker for HPV; thus, negative participants did not have the p16 marker."|Up to 28 days prior to the first dose of lapatinib/placebo|ITT Population||Participants|||Number
149980|NCT00387127|Secondary|Analysis of Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) From Tumor Samples|No analysis was performed for tumor sample RNA/DNA.|Screening|ITT Population. DNA/RNA from tumors has not been analyzed (tested); therefore, data are not available. No suitable analyses of DNA/RNA have been proposed for this small sample size of tumor samples.|||||
150004|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||hospitalisations for COPD exacerbations||Full Range|Median
149981|NCT00387127|Secondary|Plasma Proteome Analysis|Proteomic analyses of blood plasma samples were to be conducted to identify any changes in the proteome profile that could be related to the treatment response. Examination of pre-dosing (screening) plasma protein profiles could uncover novel blood-borne protein candidate biomarkers/profiles, which could be used to predict drug response.|From up to 28 days prior to the first dose of lapatinib/placebo start to 8 weeks after the first dose|ITT Population. Plasma proteome data have not been analyzed (tested); thus, data are not available to disclose. Based on the negative outcome of Study EGF102988 (NCT00424255), no suitable analyses have been proposed for this small sample size.|||||
149982|NCT00387127|Secondary|Number of Participants Positive and Negative for the Expression of Biomarkers in Tumor Tissue: Human Epidermal Growth Factor Receptor (HER)-1, HER2, HER3, HER4, P16, and Transforming Growth Factor (TGF-alpha)|Paraffin-embedded tissue block (or sections) from archived tumor tissue sample, if available (from time of original diagnosis) or fresh tumor tissue, was sent for testing to determine intra-tumoral biomarker expression by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay. Stained tumor slides or tissue micro arrays (TMAs) were scored by a pathologist from 0 (no expression) to 3+ (high expression). An expression level of >=2+ was considered positive.|Up to 28 days prior to the date of the first dose of lapatinib/placebo start|ITT Population. Only those participants who had sufficient tumor sample for testing were analyzed.||Participants|||Number
149983|NCT00387127|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Participants with OR were those who achieved either a CR or partial response (PR) from the assessment of overall tumor response at 6 months (24 weeks) following completion of CRT (data cut-off 30-Sep-2010). Per RECIST, CR is defined as the disappearance of all target and non-target lesions; PR is defined as at least a 30% decrease in the sum of the long diameter (LD) of target lesions, taking as a reference, the baseline sum LD. Data are based on Week 24 scans from participants receiving study treatment at that time point.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median of 13 months|ITT Population||Participants|||Number
149984|NCT00387127|Secondary|Distant Relapse|Distant relapse is defined as the time from the date of randomization until the first occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ of part). Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population. If a participant had a distant metastasis and then died, then the participant was counted as having had an event of interest.||Months||Inter-Quartile Range|Median
149985|NCT00387127|Secondary|Number of Participants With Distant Recurrence of Initial Disease|Participants were analyzed for the occurrence of distant metastasis (spread of a disease from one organ or part to another non-adjacent organ or part) after randomization in the study until data cut-off date 1-Aug-2014. Participants who died or had recurrence of disease in the T or N sites or secondary primary malignancies in the head and neck region outside of the original T and N site were not counted as an event and were instead treated as competing risks.|From the date of randomization until the first occurrence of distant metastasis, assessed after a median of 30.9 months|ITT Population||Participants|||Number
149986|NCT00387127|Secondary|Loco-regional Control|Loco-regional control is defined as the time from the date of randomization until progression in the T or N site. Participants who died or had secondary primary malignancies in the head and neck region outside of the T and N site or distant metastasis were not counted as an event and were instead treated as competing risks. Per the TNM staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. Due to the minimal events reported (data cut-off 30-Sep-2010), valid analysis could not be performed for loco-regional control rate.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population|||||
149987|NCT00387127|Secondary|Number of Participants With Loco-regional Recurrence of Initial Disease|Participants with loco-regional recurrence were those who had progression of disease in the T and N sites. Per the Tumor, Node, and Metastases (TNM) staging of tumors: T describes the size of the tumor and whether it has invaded nearby tissue, and N describes regional lymph nodes that are involved. If a participant had progression in the T or N sites, then the participant was counted as having had an event of interest.|From the date of randomization until progression in the T or N site or death due to any cause, assessed after a median of 30.9 months|ITT Population||Participants|||Number
149988|NCT00387127|Secondary|Disease-specific Survival|Disease-specific survival is defined as the time from randomization until death due to head and neck cancer.|From the date of randomization until the date of death due to disease, assessed after a median of 13 months of follow-up|ITT Population. For participants who did not die, time to death was censored at the time of last contact.||Months||Inter-Quartile Range|Median
149989|NCT00387127|Secondary|Number of Participants Who Died Due to Progressive Disease|The number of participants who died due to progressive disease (a >=20% increase in the sum of the longest diameter of target lesions, or the appearance of >=1 new lesion, symptomatic progression and/or unequivocal progression of existing non-target lesions), or died due to head and neck cancer without evidence of disease progression, after randomization in the study is presented, using a data cut of 1 August 2014.|From the date of randomization until the date of death due to disease under study, assessed after a median of 30.9 months|ITT Population||Participants|||Number
149990|NCT00387127|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Time to death (data cut-off 1-Aug-2014) was censored at the time of last contact for participants who did not die.|From the date of randomization until the date of death due to any cause, assessed after a median of 30.9 months|ITT Population||Months||95% Confidence Interval|Median
150005|NCT00387088|Secondary|Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted|Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||hospitalisations for COPD exacerbations||Full Range|Median
149991|NCT00387127|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS=the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Per RECIST, progressive disease=a >=20% increase in the sum of the longest diameter of target lesions (TLs), or the appearance of >=1 new L, symptomatic progression and/or unequivocal progression of existing non-TLs. For participants who did not progress or die at the time of reporting (data cut-off 1-Aug-2014), PFS data were censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy.|From the date of randomization until the date of disease progression or death due to any cause, assessed after a median of 22 months of follow-up|ITT Population||Months||95% Confidence Interval|Median
149992|NCT00387127|Secondary|Number of Participants With CR, as Assessed by the Investigator|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the CRT, as determined by the investigator. Tumor response was assessed using modified RECIST criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed after a median time of 13 months of follow-up|ITT Population||Participants|||Number
149993|NCT00387127|Primary|Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review|Participants with CR are defined as those who achieved a complete tumor response at 6 months after the completion of the chemoradiation treatment (CRT), as assessed by independent radiological review. Tumor response was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per RECIST, CR is defined as the disappearance of all target and non-target lesions. Data are based on Week 24 scans from participants receiving study treatment at that time and on those in follow-up.|From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, regardless of whether they actually received study medication||Participants|||Number
149994|NCT00387088|Secondary|Clinically Relevant Findings in Physical Examination and ECG|Clinically relevant findings in Physical Examination and ECG at end of treatment|End of treatment|Treated set||participants|||Number
149995|NCT00387088|Secondary|Marked Changes From Baseline in Vital Signs at End of Treatment|"Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.~SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.~DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.~PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm."|Baseline and end of treatment|Treated set||participants|||Number
149996|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.||Litres||Standard Error|Least Squares Mean
149997|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FVC data.||Litres||Standard Error|Least Squares Mean
149998|NCT00387088|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29|Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FVC data.||Litres||Standard Error|Least Squares Mean
149999|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
150000|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337|The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. Up to 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
150001|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
150002|NCT00387088|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337|The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 534 participants from the FAS were excluded due to insufficient SGRQ data.||Units on a scale||Standard Error|Least Squares Mean
150003|NCT00387088|Secondary|Number of Patients With at Least One Hospitalisation for a COPD Exacerbation|Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||participants|||Number
150007|NCT00387088|Secondary|Number of Patients With at Least One COPD Exacerbation|Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||participants|||Number
150008|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - naïve Estimate|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||COPD exacerbations||Full Range|Median
150009|NCT00387088|Secondary|Number of COPD Exacerbations Per Patient - Exposure Adjusted|Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||COPD exacerbations per year||Full Range|Median
150010|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 169|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.||Litres||Standard Error|Least Squares Mean
150011|NCT00387088|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29|Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.|Baseline and Day 29|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data.||Litres||Standard Error|Least Squares Mean
150012|NCT00387088|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.|During actual study treatment period (planned Day 1 to Day 337)|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.||Days||95% Confidence Interval|Median
150013|NCT00387088|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337|Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).|Baseline and Day 337|The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data.||Litres||Standard Error|Least Squares Mean
150014|NCT00387036|Secondary|Exercise Endurance Time|Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.|2 Weeks|Intention to treat analysis. All patients were included.||Minutes||Standard Deviation|Mean
150015|NCT00387036|Primary|Standardized Dyspnea Score at Isotime During Exercise|"Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.~Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 [Best] - 10 [Worst] )."|2 Weeks|Intention to treat analysis. All patients were included.||Units on a Scale||Standard Deviation|Mean
150016|NCT00387023|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.|3 months|||participants|||Number
150017|NCT00387010|Secondary|Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)|During the dose titration period, participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg if needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated. This outcome summarizes the successful dose levels identified during the titration period.|up to 10 days|Safety analysis set||participants|||Number
150018|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's enjoyment of life.|approximately week 5|Full analysis set||participants|||Number
150019|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's relationship with others.|approximately week 5|Full analysis set||participants|||Number
150217|NCT00385944|Secondary|Change in MPA to 20 μM ADP From Baseline to 6-18 Hrs Post Loading Dose (LD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|Baseline to 6-18 hrs post loading dose (LD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage aggregation||Standard Deviation|Mean
150020|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's ability to work and perform activities of daily living.|approximately week 5|Full analysis set||participants|||Number
150021|NCT00387010|Secondary|Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's walking ability.|approximately week 5|Full analysis set. One participant was not assessed by the investigator.||participants|||Number
150022|NCT00387010|Secondary|Clinical Assessment of Patient Function - General Activities - at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) investigators completed the Clinical Assessment of Patient Function Scale which asks 5 questions about the effect of study treatment on the patient's ability to function. This question asks about the patient's general activities.|approximately week 5|Full analysis set||participants|||Number
150023|NCT00387010|Secondary|Patient Assessment of Ability to Enjoy Life at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to enjoy life.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
150024|NCT00387010|Secondary|Patient Assessment of Ability to Have Sex at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to have sex.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
150025|NCT00387010|Secondary|Patient Assessment of Ability to Participate in Social Events at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to participate in social events.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
150026|NCT00387010|Secondary|Patient Assessment of Ability to Exercise at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to exercise.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
150027|NCT00387010|Secondary|Patient Assessment of Ability to Walk at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to walk.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
150028|NCT00387010|Secondary|Patient Assessment of Ability to Perform at Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to perform at work and includes both work outside the home and housework.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
150029|NCT00387010|Secondary|Patient Assessment of Ability to Go to Work at Approximately Week 5|At the endpoint of the study (week 4 of Treatment period or last post baseline visit) participants completed the Patient Assessment of Function Scale which asks 7 questions about the effect of study treatment on the patient's ability to function. This question asks about the ability to go to work.|approximately week 5|Full analysis set of participants who answered the question||participants|||Number
150030|NCT00387010|Secondary|Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5|The summary question from the Pain Flare Treatment Satisfaction Questionnaire asked participants which medication they preferred to use for their break-through pain. Options were 1) Prior medication 2) Study medication 3) no preference|approximately week 5|Full analysis set of participants who answered the questions.||participants|||Number
150031|NCT00387010|Secondary|Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Multidimensional Pain Inventory Subscales. Answers to questions in the MPI are captured on a 7-point scale, with 0=most positive answer and 6= least positive answer. Twenty questions focus on pain, fourteen on a significant other's response when participant is in pain, and eighteen questions about daily activities. There are a total of 13 subscales with variable ranges. Subscales and corresponding ranges are listed in the results table. The General Activity category combines the Household Chores, Outdoor Work, Activities Away from Home, and Social Activities categories.|Day 0 (baseline), approximately week 5|Full analysis set||units on a scale||Standard Deviation|Mean
150032|NCT00387010|Secondary|Change From Baseline in the Beck Depression Inventory at Approximately Week 5|Change from baseline to endpoint (week 4 of Treatment period or last post baseline visit) in the Beck Depression Inventory (BDI). The BDI is a self-reporting instrument that asks 21 questions regarding how the participant felt in the past few days. Answers are in sentence form, and offer a scale where the first answer (worth 0 points) indicates no depression and the fourth answer (worth 3 points) indicates significant depression. Totals (0-63) are grouped so that totals of 1-10 are interpreted as 'These ups and downs are considered normal' and scores >40 indicate extreme depression.|Day 0 (baseline), approximately week 5|Full analysis set of participants who answered the questions.||units on a scale||Standard Deviation|Mean
154836|NCT00338039|Primary|Median Overall Survival|Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.|Baseline to disease progression or death, up to 4 years|||Months||95% Confidence Interval|Median
150033|NCT00387010|Secondary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5|The change from baseline to approximately week 5 in the PASS subscale scores. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. Those 40 questions are organized into four subscales: fear, cognitive anxiety, somatic anxiety, and escape/avoidance. Each subscale score is obtained by summing the answers to the ten items in the subscore resulting in a range of 0-50.|Day 0 (baseline), approximately week 5|Full analysis set||units on a scale||Standard Deviation|Mean
150034|NCT00387010|Primary|Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5|The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.|Day 0 (baseline), approximately week 5|Full analysis set||units on a scale||Standard Deviation|Mean
150035|NCT00386880|Primary|Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine|Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.|Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia.|||participants|||Number
150036|NCT00386776|Secondary|Completeness of Patients' Problem Lists|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
150037|NCT00386776|Secondary|Number of Telephone Calls and E-mail Messages Between Patients and Physicians|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
150038|NCT00386776|Secondary|Time Per Visit|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
150039|NCT00386776|Secondary|Number of Office Visits by Patients|The experimental design was revised from a two arm experimental and control study to a one arm experimental study. Therefore this secondary measure no longer applied.|||||||
150040|NCT00386776|Primary|Physician Post Visit Questionnaire|"The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the physician at the time of the patient visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the questions “How helpful was it for your patient to have taken the computer interview before seeing you?~” and the question To what extent do you think the computer summary helped you to provide better care to your patient? We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the physician responses to the post-visit questionnaires when physicians filled out the questionnaire but their patients did not."|One day after the patient visit|We analyzed post visit physician questionnaire responses for the patients who completed the medical history and who showed up for their appointment.||units on a scale||Full Range|Mean
150041|NCT00386776|Primary|Patient Post Visit Questionnaire|The questionnaire consisted of 6 Likert scales questions assessing helpfulness of the computer-based history for the patient at the time of the visit. The Likert scale ranged from 1 for 'Not at all helpful' to 10 for 'Very helpful'. We computed the mean of the responses to the question “How helpful was it for you to have taken the computer interview before seeing your doctor?” We also calculated a total score by averaging the mean scores of the 6 questions. In addition we calculated the combined mean of the responses of three of the patients whose doctors did not complete their post-visit questionnaire.|One day after the visit with the physician|We analyzed post medical history questionnaire responses for the 23 patients who completed the medical history patients.||units on a scale||Full Range|Mean
150042|NCT00386776|Primary|Patient Post Medical History Assessment Questionnaire|"The questionnaire consisted of 10 Likert scales questions assessing the computer-based history. The Likert scale ranged from 1 for 'Not at all' to 10 for 'Very'.~We computed the mean of the responses to the question “How helpful were the questions when thinking about your health? We also calculated a total score by averaging the mean scores of the 10 questions."|Immediately after taking the medical history|We analyzed post medical history questionnaire responses for the 32 patients who completed the medical history patients.||units on a scale||Full Range|Mean
150043|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment||Month 18|Treated population||Percentage of patients|||Number
150044|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure||Baseline and Month 18|Treated population||mmHg||Standard Deviation|Mean
150045|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events|adverse event data obtained from both the core study and the 6 month extension study.|Month 18|||percentage of patients|||Number
150046|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure||Baseline and Month 18|Treated population||mmHg||Standard Deviation|Mean
150047|NCT00386607|Secondary|Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg||.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population||Percentage of patients|||Number
150048|NCT00386607|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54|Treated population||mmHg||Standard Deviation|Mean
150049|NCT00386607|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure.||Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54|Treated population||mmHg||Standard Deviation|Mean
150050|NCT00386607|Primary|Overall Percentage of Patients With Adverse Events||Month 12|Treated population: All patients who received at least one dose of Aliskiren/Valsartan||percentage of patients|||Number
150051|NCT00386477|Primary|Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.|Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.|1 month|Randomization||participants|||Number
150052|NCT00386425|Post-Hoc|Mortality for Moderate Protein C Deficiency by Infusion Duration||28 Days|ITT Population - ITT Switch-No Population, ITT patients who did not answer yes to the switch question.||percent participants deceased|||Number
150053|NCT00386425|Other Pre-specified|Mortality for Severe Protein C Deficiency|Twenty-eight day mortality is the patient's mortality status at the predefined timepoint of 672 hours from the start of study drug infusion. Hospital mortality is the patient's survival status at the end of the hospital stay or study day 90 (if the patient remains in the hospital).|28 Days, up to 90 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy. ITT patients with severe protein C deficiency. Severe deficiency is defined by the 24-hour local laboratory protein C value reported to the Interactive voice response system (IVRS).||Percentage of participants|||Number
150054|NCT00386425|Secondary|Mortality by Protein C Normalized Versus Not-normalized|Normalization was defined as having 2 consecutive protein C measurements above the lower limit of normal through Study Day 7.|28 days|ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy||Percentage of participants|||Number
150055|NCT00386425|Secondary|Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period|Serious bleeding events (SBE): intracranial hemorrhage, life-threatening or fatal bleed, or bleeding event assessed as an SAE. Patients may have multiple events with onset in different time periods. SAEs include SBEs. The 3 SBEs in Alternative-Moderate Deficiency arm (days 5-8) occurred after completion of study drug infusion. One event (pleural haemorrhage) occurred same day of completion of infusion and 2 events (cerebral haemorrhage, shock haemorrhagic) occurred day after completion.|Day 0 through Day 28|Randomized participants who received randomized therapy (intention to treat population).||number of patients with at least 1 event|||Number
150056|NCT00386425|Secondary|28-Day Time Averaged Sequential Organ Failure (SOFA) Score|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction). SOFA scores were time-averaged.|Day 0, Day 28|ITT population||Units on a scale||Standard Deviation|Mean
150057|NCT00386425|Secondary|Hospital Mortality (up to Day 90)||Day 0 to hospital discharge or Day 90|ITT population||Percentage of participants|||Number
150058|NCT00386425|Secondary|Day 28 All-Cause Mortality||Day 0 through Day 28|ITT population||percentage of participants|||Number
150059|NCT00386425|Secondary|Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency|"Moderate Protein C Deficiency: A protein C level greater than half the lower limit of normal.~Severe Protein C Deficiency: A protein C level less than or equal to half the lower limit of normal."|Day 1, Day 7|ITT moderately deficient population, ITT severely deficient population||Percent Protein C Activity||Standard Deviation|Mean
150060|NCT00386425|Primary|Mean Change in Protein C Levels From Day 1 to Day 7|Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.|Day 1, Day 7|Intent to Treat (ITT) Last Observation Carried Forward (LOCF) population.||Percent Protein C Activity||Standard Deviation|Mean
150061|NCT00386360|Secondary|Height, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150062|NCT00386360|Secondary|Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12|Electrochemiluminescence assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150063|NCT00386360|Secondary|Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12|ELISA / enzyme-linked immunosorbent assay method by central lab|Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150064|NCT00386360|Secondary|Greater Trochanter BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150065|NCT00386360|Secondary|Femoral Neck BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150066|NCT00386360|Secondary|Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150067|NCT00386360|Secondary|Lumbar Spine BMD, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150068|NCT00386360|Secondary|Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150069|NCT00386360|Secondary|Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150070|NCT00386360|Secondary|Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150071|NCT00386360|Secondary|Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150072|NCT00386360|Secondary|Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|PP - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
150073|NCT00386360|Secondary|Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12||Baseline and Month 12|Per Protocol (PP) Population - all patients in ITT population who had no major protocol violations.||Percent Change||95% Confidence Interval|Least Squares Mean
155345|NCT00330382|Secondary|Number of Participants Report at Least 1 Adverse Event During the Study|The onset of adverse event is between the randomizaiton date and off-study date|Randomized date to Off-study date, up to 21 months|||participants|||Number
150075|NCT00386334|Secondary|Mean Sheehan Disability Total Scores|Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).|Weeks 0,6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150076|NCT00386334|Secondary|Mean Change From Baseline in the Sheehan Disability Scale Total Score.|Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150077|NCT00386334|Secondary|Mean Mental Component Summary of the Short Form-36 Scale Scores|This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150078|NCT00386334|Secondary|Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores|Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150079|NCT00386334|Secondary|Mean Physical Component Summary of the Short Form-36 Scale Scores.|This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).|Weeks 0,6,12,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150080|NCT00386334|Secondary|Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale|Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.|Baseline (week 0), Weeks 6, 12, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150081|NCT00386334|Secondary|Mean Insomnia Severity Index Total Scores at Various Study Time Points|The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150082|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150083|NCT00386334|Secondary|Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
150084|NCT00386334|Secondary|Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points|The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Median
150085|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points|Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Mean
150086|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.|Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||percentage of total asleep time||Standard Deviation|Mean
150087|NCT00386334|Secondary|Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.|The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150088|NCT00386334|Secondary|Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150089|NCT00386334|Secondary|Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
150090|NCT00386334|Secondary|Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Week 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
150091|NCT00386334|Secondary|Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
150092|NCT00386334|Secondary|Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||number of naps||Standard Deviation|Mean
150093|NCT00386334|Secondary|Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
150094|NCT00386334|Secondary|Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
150095|NCT00386334|Secondary|Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||number of awakenings||Standard Deviation|Mean
150096|NCT00386334|Secondary|Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).|weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150097|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150098|NCT00386334|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
150099|NCT00386334|Secondary|Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.|Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) & average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150100|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points|Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150101|NCT00386334|Secondary|Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period|Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
150102|NCT00386334|Secondary|Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points|Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).|Weeks 0,1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150103|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points|Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.|Baseline (week 0), Weeks 1,4,7,12,13,15|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150218|NCT00385944|Secondary|Poor Responder of MPA to 20 μM ADP Following Maintenance Dose (MD)|Poor responder is defined as MPA to 20 μM ADP >75th percentile of the value at 6-18 hours post-clopidogrel LD.|14 days after maintenance dose (MD)|||Participants|||Number
150104|NCT00386334|Secondary|Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period|Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.||minutes||Standard Deviation|Mean
150105|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Median
150106|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||percentage of total asleep time||Standard Deviation|Mean
150107|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||percentage of total asleep time||Standard Deviation|Mean
150108|NCT00386334|Secondary|Mean Subject-Reported Total Nap Time at Various Study Time Points|The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150109|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150110|NCT00386334|Secondary|Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
150111|NCT00386334|Secondary|Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.|The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
150112|NCT00386334|Secondary|Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.||number of naps||Standard Deviation|Mean
150113|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period|Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose)- week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||number of naps||Standard Deviation|Mean
150114|NCT00386334|Secondary|Mean Subject-reported Physical Well-Being at Various Study Time Points|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150115|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150116|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period|Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
150117|NCT00386334|Secondary|Mean Subject-reported Ability to Concentrate at Various Study Time Points|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150118|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150119|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.|Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseliine (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
150120|NCT00386334|Secondary|Mean Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150121|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150122|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period|Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
150123|NCT00386334|Secondary|Mean Subject-reported Daytime Alertness at Various Study Time Points.|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150124|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150125|NCT00386334|Secondary|Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period|Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
150126|NCT00386334|Secondary|Mean Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150127|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150128|NCT00386334|Secondary|Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.|Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - week 12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
150129|NCT00386334|Secondary|Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150130|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.|Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
150131|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period|Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||units on a scale||Standard Deviation|Mean
150132|NCT00386334|Secondary|Mean Number of Awakenings (Subject-reported) at Various Study Time Points|Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
150133|NCT00386334|Secondary|Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.|The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||number of awakenings||Standard Deviation|Mean
150134|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.|The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||number of awakenings||Standard Deviation|Mean
150135|NCT00386334|Secondary|Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150136|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.|Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150137|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.|Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) -week 12|Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
150138|NCT00386334|Secondary|Mean Subject-reported Sleep Latency Reported at Various Study Time Points.|Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).|Weeks 0,3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150139|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points|Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.|Baseline (week 0), Weeks 3,6,9,12,14,16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150140|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.|Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose) - Week12|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
150141|NCT00386334|Secondary|Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.|The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.||minutes||Standard Deviation|Mean
150142|NCT00386334|Secondary|Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.|The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.|Weeks 0, 3, 6, 9, 12, 14, 16|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.||minutes||Standard Deviation|Mean
150143|NCT00386334|Primary|Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.|The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.|Baseline (week 0), Day 1 (post first dose)-12 weeks|Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.||minutes||Standard Deviation|Mean
150144|NCT00386308|Primary|Mean Reduction From Baseline in Menstrual Blood Loss (MBL)|reduction of menstrual blood loss in mL|Baseline MBL over 6 menstrual cycles|modified intent to treat population||mL||Standard Deviation|Least Squares Mean
150145|NCT00386308|Secondary|Responder Analysis - Reduction in Large Stains|Percentage of subjects who experienced a reduction from baseline in the frequency of large stains|Reduction from Baseline over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||percentage of subjects|||Number
150146|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
150147|NCT00386308|Secondary|Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding|A positive unit change mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited|Change from Baseline scores over 6 menstrual cycles|modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)||units on a scale||Standard Deviation|Least Squares Mean
150148|NCT00386256|Primary|HB/Phone Adherence|An 11-week text messaging or phone adherence rate was calculated by dividing the number of response days via the HB or phone divided by 77 days and multiplied by 100. This first calculation estimated the text messaging or phone adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|Monthly over 3 months|||percentage of days adhered||Standard Deviation|Mean
150149|NCT00386256|Primary|Exercise Adherence|An 11-week exercise adherence rate was calculated by dividing the total number of days that the participant reported exercising by 77 days and multiplying by 100. This first calculation estimated the exercise adherence rate for the full intervention period regardless of participant dropout. Eleven weeks rather than 12 weeks was used in the denominator because subjects received their HB units some time during the first week of study enrollment and may have missed some days during this first week.|at monthly intervals, for 3-months|||percentage of days adhered||Standard Deviation|Mean
150150|NCT00386243|Primary|Brief Pain Inventory (Interference)|"This is an 7-item measure that provides scores for pain-related functional impairment. The seven (7) pain interference items are rated on a simple numeric rating scale from 0-10. On the scale 0 represents no interference and 10 is completely interferes. The pain interference score is achieved by taking the total of all seven (7) scores and dividing it by the number of items (7)."|Baseline and 9 months|||units on a scale||Standard Deviation|Mean
150151|NCT00386243|Secondary|Pain Self-efficacy (Arthritis Self-efficacy Scale)||at baseline, 3, 6, and 9 months||||||
150152|NCT00386243|Secondary|Generic HRQL (SF-12)||at baseline, 3, 6, and 9 months||||||
150153|NCT00386243|Secondary|Work Function (Work and Health Interview)||at baseline, 3, 6, and 9 months||||||
150154|NCT00386243|Secondary|Clinical Response (Global Rating of Change)||at baseline, 3, 6, and 9 months||||||
150155|NCT00386243|Secondary|Psychological Distress (PHQ-9, MCS Score of SF-12, PRIME-MD Anxiety, PTSD Checklist (PCL-17))||at baseline, 3, 6, and 9 months||||||
150156|NCT00386243|Primary|Roland-Morris Disability Questionnaire|This is a 24-item pain specific disability questionnaire consisting of 24 questions which are related specifically to physical functions that are likely to be affected by back pain. The questionnaire is scored by adding up the number of items checked by the subject (0-24 range). Greater levels of disability are reflected by higher numbers.|at baseline and 9 months|||scores on a scale||Standard Deviation|Mean
150157|NCT00386152|Secondary|Number of Patients (Hb >= 11 g/dL) During Study.||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit||participants|||Number
150158|NCT00386152|Secondary|Time to Achieve Hb >= 11 g/dL During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit||days||95% Confidence Interval|Median
150159|NCT00386152|Primary|Hemoglobin (Hb) Change From Baseline to Study Week 7|Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication|Baseline (Week 1) and Week 7|per-protocol (PP) population that includes a subset of the modified intent-to-treat (mITT) population with subjects who were randomized and received at least one dose of study medication, had transfusion-unrelated Hb values obtained at both baseline and Week 7, met inclusion and exclusion criteria, and had no major protocol violations up to Week 7||g/dL||Standard Deviation|Mean
150160|NCT00386152|Secondary|Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study||up to 16 weeks|modified intention-to-treat (mITT) population that includes the subjects who were randomized, received at least one dose of study medication, and had transfusion-unrelated Hb values obtained at baseline and at least one post baseline visit||participants|||Number
150161|NCT00386100|Secondary|Percent Change From Baseline in Bone Alkaline Phosphatase (BSAP) at Weeks 20, 56, and 80|Blood was taken for measurement of BSAP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BSAP measurements at Week 20 or later were included.||percent change|||Number
150162|NCT00386100|Secondary|Percent Change From Baseline in Procollagen Type-1 N-propeptide (P1NP) at Weeks 20, 56, and 80|Blood was taken for measurement of P1NP. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with P1NP measurements at Week 20 or later were included.||percent change|||Number
150163|NCT00386100|Secondary|Percent Change From Baseline in C-terminal Telopeptide (CTX) at Weeks 20, 56, and 80|Blood was taken for measurement of CTX. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with CTX measurements at Week 20 or later were included.||percent change|||Number
150187|NCT00386100|Secondary|Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80|Blood was taken for serum Hb1AC measurements. Hb1AC responders were described as participants having achieved Hb1AC <=6% and <7% at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||participants|||Number
150164|NCT00386100|Secondary|Percent Change From Baseline in Estradiol at Weeks 20, 56, and 80|Blood was taken for measurement of estradiol. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of female participants in the bone study only. n is the number of evaluable participants, which is the number of female participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with estradiol measurements at Week 20 or later were included.||percent change|||Number
150165|NCT00386100|Secondary|Percent Change From Baseline in 25-hydroxy Vitamin D at Week 80|Blood was taken for measurement of 25-hydroxy vitamin D. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with 25-hydroxy vitamin D measurements at Week 20 or later were included.||percent change|||Number
150166|NCT00386100|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone at Week 80|Blood was taken for measurement of intact parathyroid hormone. Percent change from baseline was based on log transformed data. Standard error, SE; Wk, Week; %, percent. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with intact parathyroid hormone measurements at Week 20 or later were included.||percent change|||Number
150167|NCT00386100|Secondary|Percent Change From Baseline in Serum Calcium at Weeks 12, 32, 56, and 80|Blood was taken for measurement of serum calcium. Percent change from baseline was based on log transformed data. Geometric mean, GM; standard error, SE. This outcome measure was analyzed for a subset of participants in the bone study only. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Weeks 12, 32, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with serum calcium measurements at Week 20 or later were included.||percent change|||Number
150168|NCT00386100|Secondary|Percent Change From Baseline in Total Body BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
150169|NCT00386100|Secondary|Percent Change From Baseline in Distal Radius BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
150170|NCT00386100|Secondary|Percent Change From Baseline in Femoral Neck BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
150171|NCT00386100|Secondary|Percent Change From Baseline in Trochanter BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
150172|NCT00386100|Secondary|Percent Change From Baseline in Total Hip BMD at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
150173|NCT00386100|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mass Density (BMD) at Weeks 20, 56, and 80 (Bone Sub-study Subset of Participants)|BMD was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD at a given timepoint was defined at the participant level by the following formula: percent change = (BMD at given week minus BMD at baseline)/BMD at baseline x 100%. This outcome measure was analyzed for a subset of participants in the bone study only.|Baseline and Weeks 20, 56, and 80|Week 20 Evaluable for the Bone Sub-study Population. This is a subset of the bone sub-study with LOCF from Week 20. Only participants with BMD assessment(s) at Week 20 or later were included.||percent change||Standard Error|Mean
150175|NCT00386100|Secondary|Slope of Delta-cell Function as Estimated by the Ratio deltaI/deltaG|The ratio Delta I/Delta G is calculated based on the oral glucose tolerance test (OGTT), where Delta I = (30 minute immunoreactive insulin minus 0 minute immunoreactive insulin) and Delta G = (30 minute plasma glucose minus 0 minute plasma glucose). The 0 minute values are fasting insulin and glucose; the 30 minute values are taken 30 minutes after the oral glucose challenge. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants from US and Mexico sites with a value at baseline and at the specified visit, were analyzed.||ratio||Standard Error|Mean
150176|NCT00386100|Secondary|Percent Change From Baseline in in HOMA-S and HOMA-B to Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of homeostasis model assessment for insulin sensitivity (HOMA-S) and beta-cell function (HOMA-B). Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only. GM, geometric mean; SE, standard error.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
150177|NCT00386100|Secondary|Change in C-peptide From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for C-peptide measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||mmol/l||Standard Error|Mean
150178|NCT00386100|Secondary|Change in Fasting Insulin From Baseline at Week 80 (US and Mexico Subset of Participants)|Blood was taken for fasting insulin measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||picomoles per Liter (pmol/l)||Standard Error|Mean
150179|NCT00386100|Secondary|Percent Change in Free Fatty Acids (FFA) From Baseline at Week 80 (US and Mexico Subset of Participants).|Blood was taken for measurement of FFA. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
150180|NCT00386100|Secondary|Percent Change From Baseline in C-reactive Protein (CRP) at Week 80 (US and Mexico Subset of Participants)|Blood was taken for measurement of CRP. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
150181|NCT00386100|Secondary|Percent Change From Baseline in Adiponectin at Week 80 (United States [US] and Mexico Subset of Participants )|Blood was taken for measurement of adiponectin. Percent change from baseline at Week 80 was based on log transformed data. This outcome measure was analyzed for a subset of participants in the US and Mexico only.|Baseline and Week 80|Week 32 Evaluable Population with LOCF for US and Mexico subset. Only evaluable participants, defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change|||Number
150182|NCT00386100|Secondary|Percent Change From Baseline in Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Triglycerides at Week 80|Blood was taken for measurement of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Percent change from baseline at Week 80 was based on log transformed data. Geometric mean, GM; standard error, SE. n is the number of evaluable participants, which is the number of participants with a value at baseline and at the specified visit for the parameter of interest.|Baseline and Week 80|Week 32 evaluable population with LOCF from Week 32. n is the number of evaluable participants, which is defined as the number of participants with a value at baseline and at the specified visit for the parameter of interest.||percent change|||Number
150183|NCT00386100|Secondary|Number of Participants Achieving Treatment Failure|Treatment failure was defined as an HbA1c level >= 7% after Week 32 or withdrawal due to insufficient therapeutic effect (ITE) at any time.|Randomization to treatment failure (up to Week 80)|ITT Population. Only evaluable participants, defined as the number of subjects with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis||participants|||Number
150184|NCT00386100|Secondary|Number of Participants Achieving FPG <=6 mmol/L (110 mg/dL) and <=7 mmol/L (126 mg/dL) at Week 80|Blood was taken for serum FPG measurements. FPG responders were described as participants having achieved FPG <=6 mmol/L (110 mg/dL) and <7 mmol/L (126 mg/dL) Hb1AC at Week 80 with LOCF from Week 32.|Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||participants|||Number
150185|NCT00386100|Secondary|Change From Baseline in FPG at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||mmol/l||Standard Deviation|Mean
150186|NCT00386100|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline at Week 80|Blood was taken for serum FPG measurements. Change from baseline was calculated as the Week 80 value minus the baseline value.|Baseline and Week 80|ITT Population. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed. Last observation carried forward (LOCF) was not used for this analysis.||millimoles per Liter (mmol/l)||Standard Error|Mean
150188|NCT00386100|Primary|Change From Baseline in HbA1c at Week 80|Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis.|Baseline and Week 80|Intent-to-Treat (ITT) Population: all participants who were randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value. Only evaluable participants, defined as the number of participants with a baseline and at least one post baseline assessment, were analyzed.||percent change||Standard Error|Mean
150189|NCT00386100|Secondary|Mean Change From Baseline in HbA1c at Week 80|Blood was taken for serum Hb1AC measurements. Change from baseline was calculated as the Week 80 value minus the baseline value, with LOCF from Week 32 for withdrawn participants or missing values.|Baseline and Week 80|Week 32 Evaluable Population with LOCF: a subset of the ITT Population with LOCF starting at Week 32. Only participants with assessment(s) at Week 32 or later were included in this population. Only evaluable participants, defined as participants with a value at baseline and at the specified visit for the parameter of interest, were analyzed.||percent change||Standard Deviation|Mean
150190|NCT00386009|Secondary|Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests|Laboratory tests that were statistically significant and clinically adverse would be reported for safety.|Baseline and 12 weeks|All randomized participants.||significant and clinically adverse labs|||Number
150191|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score|The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||units on a scale||Standard Deviation|Mean
150192|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction|Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.|Baseline and 12 weeks|Number of participants in the Primary Analysis Population with involuntary detrusor contractions during bladder filling at both baseline and endpoint.||milliliters||Standard Deviation|Mean
150193|NCT00386009|Secondary|Presence of Involuntary Detrusor Contractions During Bladder Filling||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||participants|||Number
150194|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies|BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||units on a nomogram||Standard Deviation|Mean
150195|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies|BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||units on a nomogram||Standard Deviation|Mean
150196|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies|Max Pdet was defined as the maximum detrusor pressure observed during voiding.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||centimeters of water (cm H20)||Standard Deviation|Mean
150197|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies|Vcomp was defined as the volume of voided urine measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
150198|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies|Qave was measured during pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters per second||Standard Deviation|Mean
150199|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies|Qmax was measured duirng pressure-flow tests.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters per second||Standard Deviation|Mean
150200|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies|Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
150201|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies|Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
150202|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies|PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
150203|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters||Standard Deviation|Mean
150204|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies|Qave was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||millilters per second||Standard Deviation|Mean
150205|NCT00386009|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies|Qmax was measured during free-flow tests using a standard calibrated flow meter.|Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||milliliters per second||Standard Deviation|Mean
150206|NCT00386009|Primary|Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)||Baseline and 12 weeks|Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment.||centimeters of water (cm H20)||Standard Deviation|Mean
150207|NCT00385996|Primary|Safety of Tarceva in the Neoadjuvant Setting|Safety will be evaluated by describing the incidence of AEs, including SAEs and discontinuation of study drug due to AEs, and incidence of abnormal clinical laboratory values from day 1 of treatment.|From the onset of the AE until 30 days after the last study drug dose, until recovery is noted, or until the Investigator determines the patient's condition is stable.|Per protocol||Participants|||Number
150208|NCT00385996|Secondary|Safety||Day 1 of treatment to 2 years.||||||
150209|NCT00385996|Secondary|Time-to-progression and Disease-free Survival.||Every 3 months for the first 6 months, then yearly for 2 years.||||||
150210|NCT00385996|Primary|Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.|High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.|High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.|Per protocol||Percentage of participants|||Number
150211|NCT00385944|Secondary|Correlation of MPA to 20 μM ADP and PRU|Pearson-correlation estimated between MPA to 20 μM ADP and Accumetrics VerifyNowTM P2Y12 PRU|Baseline through 29 days of treatment|||Correlation coefficient|||Number
150212|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)|Bleeding events will be classified according to the GUSTO definitions as follows: Severe or Life-Threatening Bleeding: any ICH OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Moderate Bleeding: any bleeding event resulting in the need for transfusion. Minor bleeding: any other bleeding event that does not require transfusion or cause hemodynamic compromise.|14 days after maintenance dose (MD)|||Participants|||Number
150213|NCT00385944|Secondary|Number of Participants With Bleeding Events According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events will be classified as Major Bleeding, Minor Bleeding, or Insignificant Bleeding according to the TIMI criteria. Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 grams/deciliter (gm/dL) but <5 gm/dL from baseline. Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.|14 days after maintenance dose (MD)|||Participants|||Number
150214|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the Second Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the second maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at Day 29.||Percentage aggregation||Standard Deviation|Mean
150215|NCT00385944|Secondary|MPA to 20 μM ADP at 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|14 days after the first maintenance dose (MD)|Subjects providing evaluable MPA to 20 μM ADP at 14 days after the first maintenance dose (MD)||Percentage aggregation||Standard Deviation|Mean
150216|NCT00385944|Secondary|Change in MPA to 20 μM ADP From 6-18 Hrs Post Loading Dose (LD) to 14 Days After the First Maintenance Dose (MD)|Maximum platelet aggregation to 20 μM ADP was assessed by LTA.|6-18 hrs post loading dose (LD) to 14 days after the first maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
150720|NCT00381849|Primary|24 Hour Urinary Cystine Excretion||baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Cystine excretion was not applicable to the Calcium Stone subjects.||mcmol/24 hours||Standard Deviation|Mean
150220|NCT00385944|Secondary|Platelet Reactivity Index (PRI)|"Platelet Reactivity Index percentage was assessed by Vasodilator-stimulated phosphoprotein (VASP). PRI percent (%) was calculated using the median fluorescence intensity (MFI) of samples included with prostaglandin E1 (PGE1) and ADP, according to the following formula:~PRI%=[(MFI(PGE1)-MFI(PGE1 + ADP)/MFI(PGE1)]x100~Lower PRI% values indicate greater P2Y12 receptor blockade."|14 days after maintenance dose (MD)|||Percentage PRI||Standard Deviation|Mean
150221|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 5 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline – RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
150222|NCT00385944|Secondary|Inhibition of Residual Platelet Aggregation (IRPA) to 20 μM ADP|"IRPA is calculated as a percent decrease of RPA from baseline using the following formula:~([RPA at baseline – RPA at time of postbaseline] / RPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
150223|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 5 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline – MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
150224|NCT00385944|Secondary|Inhibition Platelet Aggregation (IPA) to 20 μM ADP|"IPA is calculated as a percent decrease of MPA from baseline using the following formula:~([MPA at baseline – MPA at time of postbaseline] / MPA at baseline) x 100%"|14 days after maintenance dose (MD)|Note: This was calculated only for subjects with a true clopidogrel-free measure at baseline (Visit 1)||Percentage inhibition||Standard Deviation|Mean
150225|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 5 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
150226|NCT00385944|Secondary|Mean Residual Platelet Aggregation (RPA) to 20 µM ADP|Residual platelet aggregation is the percentage (%) aggregation value as measured by LTA at 6 minutes after the addition of ADP.|14 days after maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
150227|NCT00385944|Secondary|MPA to 5 μM ADP|Maximum platelet aggregation to 5 μM ADP was assessed by LTA.|14 days after maintenance dose (MD)|||Percentage aggregation||Standard Deviation|Mean
150228|NCT00385944|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP)|Maximum platelet aggregation (MPA) to 20 μM adenosine diphosphate (ADP) was assessed by light transmission aggregometry (LTA).|14 days after maintenance dose (MD)|The primary analysis was performed on the intent-to-treat (ITT) population, that is, all randomized subjects with a maintenance dose MPA measured for at least one of the treatments.||Percentage aggregation||Standard Deviation|Mean
150229|NCT00385918|Secondary|Step Activity Monitor|"The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment.~This measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months|||steps||Standard Deviation|Mean
150230|NCT00385918|Secondary|10-meter Walk|"A functional capacity test to measure speed.~This measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching.~Note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months|||seconds||Standard Deviation|Mean
150231|NCT00385918|Secondary|Six Minute Walk|"A functional capacity test to evaluate walking distance during a 6-minute time frame.~This measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured Baseline (Time point 0) and 3 months|||meters||Standard Deviation|Mean
150232|NCT00385918|Secondary|Bone Mineral Content|"DXA assessment of bone mineral content.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months|||kg||Standard Deviation|Mean
150233|NCT00385918|Secondary|Lean Muscle Mass|"DXA measurement of total lean muscle mass.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0) and 3 months|||kg||Standard Deviation|Mean
150234|NCT00385918|Primary|Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.|"Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months|||ml/kg/min||Standard Deviation|Mean
150235|NCT00385918|Secondary|Percent Body Fat|"An assessment of percent body fat as determined by DXA analysis.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months|||percent of total mass||Standard Deviation|Mean
150236|NCT00385918|Secondary|Body Mass|"DXA assessment of total body mass.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|Measured at Baseline (Time point 0), 3, and 6 months|||kg||Standard Deviation|Mean
150237|NCT00385918|Primary|Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments|"Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness.~Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues."|0, 1.5 and 3, 4.5, and 6 months|A single outlier point in the baseline data in one control subject was noted. Laboratory journal notes for this subject indicated that this individual had far more episodes of robotic treadmill stops during his baseline testing due to a high degree of spasticity. Given this, we felt justified in excluding this outlier from further data analysis.||ml/kg/min||Standard Deviation|Mean
150238|NCT00385840|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||fold increase||95% Confidence Interval|Mean
150239|NCT00385840|Secondary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||subjects|||Number
150240|NCT00385840|Secondary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||subjects|||Number
150241|NCT00385840|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom results were available for antibodies against at least one study vaccine antigen component.||titers||95% Confidence Interval|Geometric Mean
150242|NCT00385840|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
150243|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
150253|NCT00385736|Secondary|Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 52|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150244|NCT00385840|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature > 39.0°C. Related = Symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
150245|NCT00385840|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all vaccinated subjects with the vaccine administration documented and symptom sheet completed.||subjects|||Number
150246|NCT00385827|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date.|Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.||days||95% Confidence Interval|Median
150247|NCT00385827|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
150248|NCT00385827|Secondary|Number of Participants With Palliative Response|Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years|Data for this outcome measure was not analyzed because minimal efficacy analysis (primary and key secondary endpoints) was done due to early termination of study.|||||
150249|NCT00385827|Secondary|Time to Clinical Deterioration (TtCD)|The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier.|Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years|Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.||days||95% Confidence Interval|Median
150250|NCT00385827|Primary|Part 2: Progression Free Survival (PFS)|The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.|Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years|Intent-to-treat (ITT) population in Part 2 included all randomized participants.||days||95% Confidence Interval|Median
150251|NCT00385827|Primary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.|Baseline up to 12 weeks after last dose administration|Safety population in Part 1 included all participants who received at least one dose of study drug.||participants|||Number
150252|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 Among Participants Who Were Systemic Corticosteroid-free at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants enrolled under any version of the protocol who took systemic corticosteroids (CS) at Baseline, received at least 1 dose of study drug, and were systemic CS-free at Week 52 were included. Nonresponder imputation was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders post-escalation.||Proportion of participants|||Number
150343|NCT00385580|Secondary|Number of Participants With BAP Response|BAP is a measure of bone metabolism. A BAP response is calculated for participants with a baseline BAP value > ULN. It is defined as on-study BAP values within normal limits.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline BAP value > ULN and at least 1 on-study value.||participants|||Number
150254|NCT00385736|Secondary|Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 52|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150255|NCT00385736|Secondary|Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 52|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150256|NCT00385736|Secondary|Proportion of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150257|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Partial Mayo Score at Week 52|"Clinical response per partial Mayo score is defined as a decrease in partial Mayo score of >= 2 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The partial Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; subjects who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150258|NCT00385736|Secondary|Proportion of Participants With Clinical Response Per Mayo Score at Week 52|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150259|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Partial Mayo Score at Week 52|"Clinical remission per partial Mayo score is defined as a partial Mayo score <= 2 and no individual subscore > 1.~The partial Mayo score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150260|NCT00385736|Secondary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 52|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 52|All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.||Proportion of participants|||Number
150261|NCT00385736|Secondary|Ranked Secondary Endpoint #12: Proportion of IBDQ Responders at Week 8 (Adalimumab 80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150344|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value > ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value >ULN and at least 1 on-study value.||participants|||Number
150262|NCT00385736|Secondary|Ranked Secondary Endpoint #11: Proportion of IBDQ Responders at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150263|NCT00385736|Secondary|Ranked Secondary Endpoint #10: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Stool Frequency Subscore ranges from 0-3 as follows:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150264|NCT00385736|Secondary|Ranked Secondary Endpoint #9: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150265|NCT00385736|Secondary|Ranked Secondary Endpoint #8: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150266|NCT00385736|Secondary|Ranked Secondary Endpoint #7: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 80/40 Versus Placebo).|"Mucosal healing defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150267|NCT00385736|Secondary|Ranked Secondary Endpoint #6: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150268|NCT00385736|Secondary|Ranked Secondary Endpoint #5: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150269|NCT00385736|Secondary|Ranked Secondary Endpoint #4: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150270|NCT00385736|Secondary|Ranked Secondary Endpoint #3: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Rectal Bleeding Subscore ranges from 0-3 as follows:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150271|NCT00385736|Secondary|Ranked Secondary Endpoint #2: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)"|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150272|NCT00385736|Secondary|Ranked Secondary Endpoint #1: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 160/80/40 Versus Placebo).|"Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150273|NCT00385736|Primary|Proportion of Participants With Clinical Remission Per Mayo Score at Week 8|"Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 1.~The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease)."|Week 8|All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.||Proportion of participants|||Number
150274|NCT00385723|Primary|ln(CES-D)|"log-transformed Center for Epidemiologic Studies Depression Scale (CES-D) score The CES-D is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.~Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms."|Baseline & 4 months|intention to treat||scores on a scale||Standard Error|Least Squares Mean
150275|NCT00385723|Primary|Serum ln(IL-6)|log-transformed serum Interleukin-6 (IL-6)|Baseline & 4 months|intention to treat||pg/ml (raw IL-6)||Standard Error|Least Squares Mean
150276|NCT00385723|Primary|Serum ln(TNF-a)|log-transformed serum Tumor Necrosis Factor-alpha (TNF-alpha)|Baseline & 4 months|intention to treat||pg/ml (raw TNF-a)||Standard Error|Least Squares Mean
150277|NCT00385684|Secondary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort.|6 weeks|||units on a scale||Standard Deviation|Mean
150278|NCT00385684|Primary|Pain Assessment in Advanced Dementia (PAINAD)|Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10.|Two (2) weeks|||units on a scale||Standard Deviation|Mean
150279|NCT00385671|Secondary|Number of Patients With Treatment-Emergent Elevated Laboratory Analytes|Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): >34, male (m): >36. Alanine Aminotransferase (ALT): f:<69 years (yr) >34, ≥69yr >32; m: <69yr >43, ≥69yr >35. Total Bilirubin (TBili): >21. Gamma Glutamyl Transferase (GGT): f: <59yr >49, ≥59yr >50; m: <59yr >61, ≥59yr >50. Fasting Plasma Glucose (FPG): <59yr >6.4, ≥59yr >6.7. Hemoglobin A1C (HbA1C) >6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr >106, 50-70yr >123, 70-80yr >164, ≥80yr >221; m: 18-50yr >129, 50-70yr >131, 70-80yr >156, ≥80yr >187|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
150280|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hemoglobin A1C||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||percent||Standard Deviation|Mean
150281|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||millimole/liter||Standard Deviation|Mean
150282|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Total Bilirubin||baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||micromole/liter||Standard Deviation|Mean
150283|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels|Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units/liter||Standard Deviation|Mean
150284|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Changes in Body Weight|"Treatment-emergent high body weight: weight at last visit >=107% of baseline weight.~Treatment-emergent low body weight: weight at last visit <=93% of baseline weight."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
150285|NCT00385671|Secondary|Number of Participants With Treatment-Emergent Elevated Heart Rate|Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
156153|NCT00325468|Primary|Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||95% Confidence Interval|Least Squares Mean
150286|NCT00385671|Secondary|Number of Participants With Treatment-emergent Elevated Blood Pressure|"Elevated systolic blood pressure: >=130 millimeter mercury (mm Hg) + an increase of >=10 mm Hg if baseline <130 mm Hg.~Elevated diastolic blood pressure: >=85 mm Hg + an increase of >=10 mm Hg if baseline <85 mm Hg."|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
150287|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Body Weight|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||kilogram||Standard Error|Least Squares Mean
150288|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Heart Rate|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||beats per minute||Standard Error|Least Squares Mean
150289|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Blood Pressure|Least-squares means represent adjustment due to baseline severity and investigative site.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||millimeter mercury||Standard Error|Least Squares Mean
150290|NCT00385671|Secondary|Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure|Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs.|baseline through 12 weeks|All randomized patients.||participants|||Number
150291|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for <56 contiguous days prior to randomization. Prior use: use of gabapentin for >=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks|Analyzed were all participants with a baseline and at least 1 non-missing post-baseline value. Last observation carried forward analysis.||units on a scale||Standard Error|Least Squares Mean
150292|NCT00385671|Secondary|Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)|Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site.|baseline, 12 weeks|The per-protocol sub-population of all randomized participants with a baseline value and >= 1 non-missing post-baseline value (modified intent-to-treat population) was included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150293|NCT00385671|Secondary|Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)|"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.~It was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible."|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150294|NCT00385671|Secondary|Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
150295|NCT00385671|Secondary|Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
150296|NCT00385671|Secondary|Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
150297|NCT00385671|Secondary|Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score|This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||days||95% Confidence Interval|Median
150298|NCT00385671|Secondary|Summary of Number of Participants Who Discontinued|Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
150299|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale|The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
150300|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150301|NCT00385671|Secondary|Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms|Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects.|baseline through 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||coefficient|||Number
150302|NCT00385671|Secondary|Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
150303|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores|The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150304|NCT00385671|Secondary|Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.||participants|||Number
150305|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores|14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150306|NCT00385671|Secondary|Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation||baseline through 12 weeks|All participants who were enrolled in the study.||participants|||Number
151819|NCT00371397|Primary|Immune Function: LPS-stimulated Production of TNF-α|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30||||||
150307|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150308|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)|The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150309|NCT00385671|Secondary|Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
150310|NCT00385671|Secondary|Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
150311|NCT00385671|Secondary|Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||participants|||Number
150312|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score|The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150313|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150314|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150315|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150316|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150317|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150318|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150319|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150320|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150321|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150322|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 Weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150323|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150324|NCT00385671|Secondary|Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Deviation|Mean
150325|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150326|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150327|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150345|NCT00385580|Secondary|Number of Participants With a Baseline BAP Value <= ULN, With a Decrease, Increase or no Change in BAP|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline BAP value <=ULN and at least 1 on-study value.||participants|||Number
150328|NCT00385671|Secondary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150329|NCT00385671|Primary|Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine|This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.|baseline, 12 weeks|All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.||units on a scale||Standard Error|Least Squares Mean
150330|NCT00385593|Secondary|Peak Expiratory Flow (PEF)|Peak expiratory flow (PEF)|6 months (end of the study)|||L/min||Full Range|Mean
150331|NCT00385593|Secondary|Change in the Asthma Control Questionnaire(ACQ) Score|The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)|Daily 14 days prior to each of visit 2-4|||Scores on a scale||Full Range|Mean
150332|NCT00385593|Secondary|Use of Inhaled Steroids|Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)|Baseline up to 6 months|||micrograms||Full Range|Mean
150333|NCT00385593|Secondary|Mean Use of as Needed Medication|Mean use of as needed medication during the treatment period|Baseline up to 6 months|||Inhalations||Full Range|Mean
150334|NCT00385593|Secondary|Total Number of Severe Exacerbations|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.|Baseline up to 6 months|||Exacerbations|||Number
150335|NCT00385593|Primary|Time to First Severe Asthma Exacerbation|Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.|Baseline up to 6 months|||Days||Standard Deviation|Mean
150336|NCT00385580|Secondary|Mean Plasma Concentration at Dose 50 mg (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
150337|NCT00385580|Secondary|Mean Plasma Concentration at 50 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
150338|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. In treatment group (100 mg, QD), no participant received a 70 mg at PK collection day.||ng/mL||Standard Deviation|Mean
150339|NCT00385580|Secondary|Mean Plasma Concentration at 70 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
150340|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 6)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
150341|NCT00385580|Secondary|Mean Plasma Concentration at 100 mg Dasatinib Dose (Week 2)|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose, 1 hour, 3 hours, 6 hours and at 12 hours after any dose for BID and QD group.|All available concentration-time data from participants who received at least 1 dose of dasatinib. The 'n' is signifying those who were evaluated for this measure at timepoint for each group respectively. Data are split by actual dose administered. If there was dose modification, participant was grouped according to dose given on PK collection day.||ng/mL||Standard Deviation|Mean
150342|NCT00385580|Secondary|Median Number of Months of BAP Response|The median number of months of the BAP response was calculated for participants with baseline BAP <= ULN, from first dose of dasatinib to the first time BAP is above ULN. For participants with baseline BAP > ULN, it was the time from BAP response to the first time BAP was above ULN. For participants with baseline BAP =< ULN or BAP, and no BAP above ULN, last BAP assessment date was used. The median number of months of response was not defined for participants with baseline value > ULN, that never achieved BAP response.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a BAP response||months||95% Confidence Interval|Median
150346|NCT00385580|Secondary|Median Number of Months of uNTx Response|uNTx is a measure of bone metabolism.The median number of months of uNTx response was calculated for participants with baseline uNTx =< ULN and uNTx progression during treatment, from first dose of dasatinib to uNTx progression.For participant with baseline uNTx above ULN, it was time from uNTx response to uNTx progression.For participants with baseline uNTx equal to or below ULN or uNTx response and no uNTx progression, the date of last uNTx assessment was used. Duration of uNTx response was not defined for participants with baseline value greater than ULN who never achieved uNTx responses.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants who demonstrated a uNTx response.||months||95% Confidence Interval|Median
150347|NCT00385580|Secondary|Number of Participants With a uNTx Response|uNTx is a measure of bone metabolism. uNTx response is defined for participants with baseline uNTx above ULN. It is defined as either on-study uNTx values decreasing to within normal limits or 35% or more decrease in uNTx from baseline, whichever happens first.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a baseline uNTx value > ULN and at least 1 on-study value.||participants|||Number
150348|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value >ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value >ULN and at least 1 on-study value.||participants|||Number
150349|NCT00385580|Secondary|Number of Participants With a Baseline uNTx Value <=ULN, With a Decrease, Increase or no Change in uNTx|uNTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All treated participants who had a baseline uNTx value <=ULN and at least 1 on-study value.||participants|||Number
150350|NCT00385580|Secondary|Number of Participants With QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heart rate. A prolonged QT interval is a risk factor for ventricular tachyarrhythmias and sudden death.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
150351|NCT00385580|Secondary|Number of Participants With Positive Urinalysis|Participants' urine samples were tested for the presence of blood, glucose and protein. If these substances were present in a participant’s urine, the results were given as “positive”.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
150352|NCT00385580|Secondary|Number of Participants With Abnormal Lactate Dehydrogenase (LD)|LDH is a laboratory safety parameter. Normal ranges for LD vary with both age and disease status, and another reason for variation in upper limit of normal (ULN) and lower limit of normal (LLN) is that LD was measured via a local (versus a standardized) laboratory. It is therefore not possible to provide one ULN and LLN for the population.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12, every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
150353|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Creatinine, Potassium, Sodium and Phosphorous|Abnormalities were graded per the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; sodium: Grade 3: 120-<130 or >155-160mEq/L, Grade 4: <120 or >160 mEq/L; creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; potassium: Grade 3: 2.5 -<3.0 or >6.0 -7.0 mEq/L, Grade 4: < 2.5 or >7.0 mEq/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
150354|NCT00385580|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin and Calcium|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
150355|NCT00385580|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the NCI CTC, version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L. Leukocytes: Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|Data was collected prior treatment with the study drug, Week 2, Week 4, Week 8, Week 12 , every 4 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
150356|NCT00385580|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy. Drug-related AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death. Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
150357|NCT00385580|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
150358|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 36|FAPSI-8:index of symptoms/concerns when assessing value of treatment for advanced prostate cancer.Participants respond to each item on 5-point Likert-type scale:0 (not at all) to 4 (very much).GP1:I have lack of energy,GP4:I have pain,GE6:I worry that my condition will get worse,C2:I am losing weight,P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do,P7:I have difficulty urinating,P8:My problems with urinating limit my activities. The number of participants for whom these data are available is too small for analysis.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants. The number of participants for whom this data are available is too small for analysis.|||||
150359|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 24|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.||Units on a scale||Full Range|Median
150360|NCT00385580|Secondary|Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36|The FAPSI-8 is a symptom index comprised of the most important clinician-rated symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. It includes 8 items developed to measure symptoms/concerns specific to prostate cancer such as fatigue, pain (3-items), weight loss, difficulty with urination (2-items) and concerns about the condition becoming worse. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much).|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.||Units on a scale||Full Range|Median
150361|NCT00385580|Secondary|Median Change From Baseline in Individual FAPSI Scores at Week 12|FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All treated participants.||Units on a scale||Full Range|Median
150362|NCT00385580|Secondary|Median Number of Months to Disease Progression|Measured from date of first dose to date of first 3 consecutive measurements that confirm PSA progression, date of disease progression,or death date.Disease progression:progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI),loss of PSA response or Investigator-defined clinical progression based on physical examination,history,symptoms,and ECOG-PS.For participants who did not progress or die,date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.||months||95% Confidence Interval|Median
150363|NCT00385580|Secondary|Number of Participants With Disease Progression|Disease progression: progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI), not as evaluated by bone scan (non-measurable lesions included visceral and bone lesions), loss of PSA response (only for participants who achieved a PSA response) or Investigator-defined clinical progression based on physical examination, history, symptoms, and ECOG-PS. For participants who did not progress or die, date of last PSA measurement or tumor assessment was used, whichever occurred first.|Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment.|All treated participants.||participants|||Number
150364|NCT00385580|Secondary|Percentage of Participants With Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|Participants with confirmed improved bone scan.||Percentage of Participants|||Number
150365|NCT00385580|Secondary|Number of Participants With a Confirmed Improved Bone Scan|An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.||participants|||Number
150366|NCT00385580|Secondary|Number of Participants With CR, PR or SD|Disease control rate is defined as the number of participants whose best response was CR, PR or SD, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD; SD: neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; PD: defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.||participants|||Number
150367|NCT00385580|Secondary|Number of Participants With CR or PR|Tumor response was defined as the number of participants whose best response was CR or PR, per RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD|Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment.|All response-evaluable participants.||participants|||Number
150384|NCT00385268|Primary|Cocaine Use as Measured by Self Report on the Time-Line Follow Back and Confirmed With Urine Drug Screen.||8 weeks||||||
150368|NCT00385580|Secondary|Number of Participants With Increase in PSA Doubling Time|PSA is a marker of prostate cancer. PSA doubling time is defined as log 2 divided by the slope of the log PSA line. An increase in PSA doubling time indicates improvement in anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements.||participants|||Number
150369|NCT00385580|Secondary|Number of Participants With Decrease in PSA Log Slope|PSA is a marker of prostate cancer. A decrease in PSA value is an early indicator of potential anti-tumor activity. Log (PSA) is assumed to have a linear relationship with time. The PSA log slope is defined as the slope of the log PSA line.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.||participants|||Number
150370|NCT00385580|Secondary|Number of Participants With Decrease in PSA Velocity|PSA is a marker of prostate cancer. PSA velocity measures the rate of change of PSA values. A decrease in PSA values and hence PSA velocity is an early indicator of potential anti-tumor activity.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements.||participants|||Number
150371|NCT00385580|Secondary|Number of Months of Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|Participants with a decrease in PSA by at least 50% from baseline||months|||Number
150372|NCT00385580|Secondary|Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.||Percentage of Participants|||Number
150373|NCT00385580|Secondary|Number of Participants With a Decrease in PSA by at Least 50% From Baseline|PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline, for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements.|Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter.|All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements.||participants|||Number
150374|NCT00385580|Primary|Percentage of Participants With a Response|Response = confirmed PSA response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD [=>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on RECIST.|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.||Percentage of Participants||95% Confidence Interval|Number
150375|NCT00385580|Primary|Number of Participants With a Response|Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =>30% in sum of longest diameter [LD] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease [PD: =>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors [RECIST].|Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.|All treated participants.||participants|||Number
150376|NCT00385541|Secondary|Mean Score on the Ramsey Scale of Sedation|The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).|1 hour after surgery, 8 hours after surgery|||score on scale||Standard Deviation|Mean
150377|NCT00385541|Secondary|The Number of Patients Who Vomited||1 hour after surgery, 8 hours after surgery|||participants|||Number
150378|NCT00385541|Secondary|Pain Assessment by Patient|Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery|||Units on a scale||Standard Deviation|Mean
150379|NCT00385541|Secondary|Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale|The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).|1 hour after surgery, 8 hours after surgery|||Units on a scale||Standard Deviation|Mean
150380|NCT00385541|Primary|Nausea Assessment by Patient|Nausea scale range: (0 = none, 10 = the worst), ordinal.|1 hour after surgery, 8 hours after surgery|Intention to treat (ITT)||Units on a scale||Standard Deviation|Mean
150381|NCT00385515|Secondary|Number of Participants With Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis.|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle|||Participants|||Number
150382|NCT00385515|Primary|Duration of Ulcerative Oral Mucositis|All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis|At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle|Analysis only includes subjects randomized to the 30mg dose of SNX-1012||Days||Standard Deviation|Mean
150383|NCT00385268|Primary|Urine Benzoylecgonine Tests (UBT)|The primary outcome measure for this trial was qualitative urine benzoylecgonine tests (UBT) obtained twice weekly. Urine collection was monitored by temperature checks. Samples less than 90 degrees, or greater than 100 degrees Fahrenheit were considered invalid and were not accepted. Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive.|8 weeks|||% of negative UBT|||Number
150391|NCT00385203|Secondary|Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 16 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 16|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||cm3||95% Confidence Interval|Mean
150392|NCT00385203|Secondary|Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.|Central review of CT images taking the total lesion volume at week 8 minus the total lesion volume at baseline.|CT assessments at Baseline and Week 8|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||cm3||95% Confidence Interval|Mean
150393|NCT00385203|Secondary|Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 16 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 16.|As per the protocol formal statistical analysis was performed for the GIST group only, STS patients were summarised. For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||mm||95% Confidence Interval|Mean
150394|NCT00385203|Secondary|-Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.|Central review of CT images taking the longest diameter measured in millimetres at week 8 [major axis (axial plane)] minus the longest diameter measured in millimetres at baseline.|CT assessments at Baseline and Week 8|As per the protocol the formal statistical analysis was performed for the GIST grouppatients only, STS patients were summarised (not STS patients). For patients to be included in the analysis they had to have CT scans at both timepoints (baseline and week 8).||mm||95% Confidence Interval|Mean
150395|NCT00385203|Secondary|Objective Tumour Response, Investigator Review|Number of patients with complete (CR) /partial response (PR) (based on RECIST) as assessed by the Investigator. CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.|RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.|||Participants|||Number
150396|NCT00385203|Primary|Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.|SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients|FDG-PET assessment at Baseline and 29 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 29).||g/mL||95% Confidence Interval|Mean
150397|NCT00385203|Primary|Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.|[F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.|Baseline and 8 days after dosing.|As per the protocol the analysis was for GIST patients only (not STS patients). For patients to be included in the analysis they had to have scans with readable results at both timepoints (baseline and Day 8).||g/mL||95% Confidence Interval|Mean
150398|NCT00385138|Secondary|Incidence of Stroke|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
150399|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
150400|NCT00385138|Secondary|Incidence of IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
150401|NCT00385138|Secondary|Incidence of MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
150402|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
150403|NCT00385138|Secondary|Incidence of All-cause Mortality or MI|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
150404|NCT00385138|Secondary|Incidence of All-cause Mortality, MI, or IDR|mITT population|randomization through 30 days post randomization|mITT population, based on available data||participants|||Number
150405|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm|Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm.|randomization through 48 hours post randomization|Safety population||participants|||Number
150406|NCT00385138|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population||participants|||Number
150407|NCT00385138|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population||participants|||Number
150408|NCT00385138|Secondary|Incidence of GUSTO Severe / Life-threatening|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours post randomization|Safety population||participants|||Number
150409|NCT00385138|Secondary|Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]|mITT population A patient could have multiple procedural events.|During index PCI|mITT population, based on available data||participants|||Number
150410|NCT00385138|Secondary|Incidence of All-cause Mortality|mITT population|randomization through 1 year post randomization|mITT population, based on available data||participants|||Number
150411|NCT00385138|Secondary|Incidence of Stroke|mITT|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
150412|NCT00385138|Secondary|Incidence of Stent Thrombosis|mITT population|randomization through 48 hours post randomization|mITT population, based on available data||participants|||Number
150418|NCT00384956|Post-Hoc|Progression-free Survival (PFS)|"PFS is defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.~Disease progression~for patients w/ <5% blasts; a ≥50% increase in blasts to >5% blasts~for patients w/ 5% to 10% blasts; a ≥50 increase to >10% blasts~for patients w/ 10% to 20% blasts; a ≥50% increase to >20% blasts~for patients w/ 20% to 30% blasts; a ≥50% increase to >30% blasts~One or more of the following ≥50% decrement from maximum remission/response levels in granulocytes or platelets, reduction in hemoglobin concentration by ≥2 g/dL or transfusion dependence"|2 years after first dose of study drug or until participant is lost to follow-up or dies|||days||Full Range|Median
150419|NCT00384956|Post-Hoc|Duration of Response (DOR)||2 years after first dose of study drug or until participant is lost to follow-up or dies|||days||Full Range|Median
150420|NCT00384956|Secondary|Rate of Relapse After Hematopoietic Stem Cell Transplant in Individuals Treated With 5-azacitidine Prior to Transplant.||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.|||||
150421|NCT00384956|Secondary|Rate of Overall Survival|Overall survival is defined as the date of first dose of study drug to the date of death from any cause.|2 years after first dose of study drug or until participant is lost to follow-up or dies|||days||Full Range|Median
150422|NCT00384956|Secondary|Rate of Cytogenetic Response||2 years after first dose of study drug or until participant is lost to follow-up or dies|This secondary outcome was not analyzed.|||||
150423|NCT00384956|Post-Hoc|Time to Best Response||4 weeks following last dose of azacitidine [median number of cycles 4.5 (1-20)]|||days||Full Range|Median
150424|NCT00384956|Secondary|Rate of Transfusion Independence||4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]|Only participants with baseline transfusion dependence were assessed for this outcome measure.||participants|||Number
150425|NCT00384956|Secondary|Rate of Hematologic Improvement|International Working Group (IWG) for Myelodysplasia (MDS).|4 weeks following last azacitidine dose [median number of cycles 4.5 (1-20)]|||participants|||Number
150426|NCT00384956|Primary|Rate of Complete Remission (CR) and Partial Remission (PR)|"Defined according to the modified International Working Group (IWG) (2006) response criteria for myelodysplasia:~CR=bone marrow with <5% myeloblasts and 0% peripheral blasts, hemoglobin ≥11g/dL, platelets ≥ 100 x 10^9/L, and neutrophils ≥1.0 x 10^9/L. Residual dysplasia was allowed.~PR= All of the CR criteria if abnormal before treatment except: bone marrow blasts decreased by ≥50% over pretreatment but still >5%."|After 4 cycles of therapy (up to 112 days after start of treatment)|||participants|||Number
150427|NCT00384930|Primary|Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Error|Least Squares Mean
150428|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain|Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
150429|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Peak Urinary Flow|Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||milliliter per second||Standard Deviation|Mean
150430|NCT00384930|Secondary|"Number of Participants Who Answer Yes to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)"|LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||participants|||Number
150431|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)|Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
150432|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
150433|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)|Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
150535|NCT00383721|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population||Liters||Standard Deviation|Least Squares Mean
150434|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
150435|NCT00384930|Secondary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore|Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|baseline and 12 weeks|Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
150436|NCT00384930|Primary|Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis|Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.|Baseline and 12 weeks|Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
150437|NCT00384813|Secondary|Brief Symptom Inventory (BSI)||4 months, 10 months||||||
150438|NCT00384813|Secondary|Parenting Stress Index - SF (PSI-SF)||4 months, 10 months||||||
150439|NCT00384813|Primary|Asthma Morbidity, as Determined by Number of Asthma Symptom Days, Number of School Days Missed Due to Asthma, and Number of Emergency Department Visits for Acute Asthma||4 months, 10 months||||||
150440|NCT00384813|Primary|Metered Dose Inhaler Checklist (MDIC)|Observational rating scale assessing MDI/spacer technique|4 months, 10 months||||||
150441|NCT00384813|Primary|Mean Score on the Family Asthma Management System Scale (FAMSS)|Family Asthma Management System Scale is semi-structured clinical interview that includes open-ended questions assessing family management of pediatric asthma. The interview is recorded and rated using a standard manual on seven core subscales and two optional subscales.The interview is recorded and rated on seven to nine 9-point subscales that tap the various domains of asthma management, with higher scores indicating better management (1 being the worse asthma management and 9 being the best asthma management). Mean of all of the subscales used to compute a total score.|4 months from baseline|||units on a scale||Standard Error|Mean
150442|NCT00384748|Primary|Physical Function as Measured by Telephone Version of FIM|The FONEFIM was developed as a telephonic alternative and yields good concordance to the in-person, performance based FIM.12 The motor subscale of the FONEFIM (Motor FONEFIM) consists of 13 items encompassing four categories: 1) self-care; 2) sphincter control; 3) transfers; and 4) locomotion. Each item is scored on an ordinal scale from 1= total dependence to 7 = total independence. Possible scores range from 13 to 91, with higher scores indicating greater independence. The scoring considers the use of adaptive equipment and/or the extent of personal assistance or supervision required to complete the task.|6-month|||units on a scale||Standard Deviation|Mean
150443|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After Second Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the second dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255|||Number of solicited general symptoms|||Number
150444|NCT00384670|Secondary|Number of Solicited Symptoms 7 Days (0-6) After First Dose of Japanese Encephalitis (JE) Vaccine.|Number of solicited general symptoms within the 7-day follow-up after the first dose of Japanese encephalitis (JE) vaccine doses (total vaccinated cohort)|Approximately Day 225 and Day 255|||adverse events|||Number
150445|NCT00384670|Secondary|Neutralizing Antibody (GMT) to JE and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Geometric mean titers (GMT) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to JE vaccine antibody titers.|Approximately Day 225 and Day 255|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.||titer||95% Confidence Interval|Geometric Mean
150446|NCT00384670|Secondary|Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.|Percentage of individuals with ≥ 10 dilution (DIL) for neutralizing (N) Ig to DEN-1, N Ig to DEN-2, N Ig to DEN-3, N Ig to DEN-4, and N Ig to Japanese encephalitis (JE) vaccine antibody titers.|30 days after the second dose of JE vaccine|1 subjects experience an asymptomatic, sub-clinical, DEN-2 virus infection prior to dengue vaccine dose 1 and was eliminated from the according to protocol (ATP) analysis of immunogenicity.||percentage of participants||95% Confidence Interval|Number
150447|NCT00384670|Secondary|Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine|Number of solicited general symptoms within the 21-day follow-up of dengue dose 2 vaccine dose (total vaccinated cohort)|21 Days (0-20) After the Second Dose of Dengue Vaccine|||adverse events|||Number
150448|NCT00384670|Secondary|Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine|Number of subjects with unsolicited symptoms classified by MedDRA Primary System Organ Class and Preferred Term, within 30 days after dengue vaccine (total vaccinated cohort)|30 days|||adverse events|||Number
150449|NCT00384670|Primary|Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine.|Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).|21 days|||adverse events|||Number
150536|NCT00383435|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.|Endpoint (26 weeks)|ITT population||Participants|||Number
150450|NCT00384397|Secondary|Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination|Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.|0-7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Percentage of Participants|||Number
150451|NCT00384397|Other Pre-specified|Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.||30 days post-Visit 2 Menactra®|Geometric mean titers and their 95% Confidence Intervals, measured by SBA-HC, were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
150452|NCT00384397|Other Pre-specified|Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-Visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
150453|NCT00384397|Primary|Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)||30 days post-visit 2 Menactra®|Antibody titers were assessed in the per-protocol population.||Percentage of Participants|||Number
150454|NCT00384293|Secondary|Change in Lipid Profile||after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed|||||
150455|NCT00384293|Primary|Change in Mean Carotid Intima Media Thickness|change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.|after 96 weeks of postrandomization treatment|study prematurely terminated, no efficacy analyses were performed|||||
150456|NCT00383565|Secondary|Median Overall Survival|Survival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.|5 Years|||months||Full Range|Median
150457|NCT00383565|Secondary|Median Progression Free-survival (PFS)|Time to disease progression is defined as the time from registration to documentation of disease progression.|2 Years|||months||Full Range|Median
150458|NCT00383565|Primary|Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment|International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.|24 weeks (6 courses of 4 week cycles)|||participants|||Number
150459|NCT00383552|Primary|Number of Participants With at Least One Severe Asthma Exacerbation at Week 26|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Week 26|||participants|||Number
150460|NCT00383552|Secondary|AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. BMI is a number calculated from a person's weight and height. The higher the number, the higher the amount of fat. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||liters * hours||Standard Deviation|Least Squares Mean
150461|NCT00383552|Secondary|Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12|Trough FEV1 is a measure of the end-of-dosing interval. The comparison was for MF/F vs F. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||liters||Standard Deviation|Least Squares Mean
150462|NCT00383552|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA)|Baseline is the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Endpoint|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||Proportion of Nights||Standard Deviation|Least Squares Mean
150463|NCT00383552|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||units on a scale||Standard Deviation|Least Squares Mean
150464|NCT00383552|Primary|Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period|Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.|Across the 26 week treatment period|Medians for time-to-event outcomes are estimated for those who had events.||Days||Inter-Quartile Range|Median
150465|NCT00383552|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The comparison was for MF/F vs placebo. Standard deviation was pooled.|Baseline to Week 26|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||units on a scale||Standard Deviation|Least Squares Mean
152049|NCT00369746|Secondary|Timeline Follow Back (TLFB) Drinking Days Per 30 Days|This variable reports drinking days in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol||days||Standard Deviation|Mean
150466|NCT00383552|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).||liters * hours||Standard Deviation|Least Squares Mean
150467|NCT00384241|Secondary|The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure|Stress induced systolic blood pressure (SBP) data generated from two previous studies was collected. In the previous studies, systolic blood pressures were measured before and after completing a video game challenge. Stress induced SBP is defined as delta SBP = stress SBP - baseline SBP.|baseline and 4 hours|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.||mmHg||Standard Deviation|Mean
150468|NCT00384241|Primary|Change in Urinary Sodium Excretion (UNaV)|The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.|Baseline and 4 hour|All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.||pg/ml||Standard Deviation|Mean
150469|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall|PACQLQ assesses the impact of the child’s asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
150470|NCT00384189|Secondary|Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score|PAQLQS is a disease specific instrument to assess the impact of asthma on the patient’s quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||score on a scale||Standard Error|Least Squares Mean
150471|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||percentage of days||Full Range|Median
150472|NCT00384189|Secondary|Change in Use of Rescue Medications|The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.||puffs/day||Standard Deviation|Mean
150473|NCT00384189|Secondary|Change in Asthma Symptom Total Score|Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.||score on a scale||Standard Deviation|Mean
150474|NCT00384189|Secondary|Change From Baseline in Diurnal PEF Fluctuations|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||percent change||Standard Deviation|Mean
150475|NCT00384189|Secondary|Change From Baseline in Evening PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last observation carried forward.||liters/minute||Standard Error|Least Squares Mean
150476|NCT00384189|Secondary|Change From Baseline in Morning PEF From Diary|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.|Baseline and Weeks 1 thru 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||liters/minute||Standard Error|Least Squares Mean
150477|NCT00384189|Secondary|Change From Baseline in Lung Function Variable PEF by Spirometry|Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis. Last Observation carried forward.||liters/minute||Standard Error|Least Squares Mean
150478|NCT00384189|Secondary|Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)|Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||liters||Standard Error|Least Squares Mean
150479|NCT00384189|Secondary|Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation|Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented.|28 days prior to last visit (Up to 12 Weeks)|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||percentage of days||Full Range|Median
150480|NCT00384189|Secondary|Time to First Event of Lack of Efficacy (LOE) by Week 12|Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period.|12 weeks|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||Percent|||Number
150481|NCT00384189|Primary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug based on the study drug they were randomized to receive, with data available for analysis.||liters/minute||Standard Error|Least Squares Mean
150482|NCT00384176|Secondary|Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)|Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.|Baseline through to data cut-off|||Days||Inter-Quartile Range|Median
150483|NCT00384176|Secondary|Percentage Change in Tumour Size|Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100|Baseline to Week 8|No statistical analyses were performed on the 30mg group. Patients had to have both a baseline and post-baseline (week 8) value to be included in the analysis. If patients did not have a week 8 assessment they were not included.||Percentage change in tumour size||Standard Deviation|Mean
150484|NCT00384176|Secondary|Duration of Response|Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.|Up until data cut-off date of 15/11/2007|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
150485|NCT00384176|Secondary|Objective Response Rate|"Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:~CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs."|Up until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Participants|||Number
150486|NCT00384176|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation until data cut-off|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
150487|NCT00384176|Primary|Progression Free Survival|Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression|Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.||Months||Inter-Quartile Range|Median
150488|NCT00384085|Secondary|Adjusted Hypoglycemic Event Rates (Event/Patient-year)|"Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study.~An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug)."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.||event per patient year||Standard Error|Mean
150489|NCT00384085|Secondary|Adjusted Incidence Rate of Hypoglycemia|"Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia.~A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event.~A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion.~Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock.~An event is included if the HE start date is within the treatment period."|Week 60|The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site.||estimated percentage per patient||Standard Error|Mean
150490|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl|"Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration.~A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms."|At week 60|Analysis was performed on the mITT population. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3, 9 from Lantus/Apidra-1 & 7 from Novolog Mix arms) were excluded from this analysis.||percentage of participants|||Number
150491|NCT00384085|Secondary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)|Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders.|At week 60|Analysis was performed on the modified intent-to-treat population which consisted of all patients who were randomized & for whom there was a baseline observation & at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (9 for Lantus/Apidra-1 & 7 for Novolog Mix arms) were excluded from this analysis.||percentage of participants|||Number
150492|NCT00384085|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)|Absolute Change in HbA1c from Baseline to Week 60.|From baseline to week 60|Analysis was performed on the modified ITT (mITT) population which consisted of all patients who were randomized, and for whom there was a baseline observation and at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3 & 7 from Novolog Mix arms) were excluded from this analysis.||percent HbA1c||Standard Error|Least Squares Mean
150493|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on the Intent To Treat (ITT) population which consisted of all patients who were randomized, and for whom there was any post-baseline follow-up information. Patients from non-GCP compliant sites were included in this analysis. This analysis was performed to ensure that study results were not compromised.||percentage of participants|||Number
150494|NCT00384085|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population|Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol.|At week 60|Analysis was performed on the Per Protocol (PP) population which included randomized patients who had no major protocol violation and who had HbA1c recorded for both Baseline & Week 60. Patients from non-GCP compliant sites were, by population definition, excluded from this analysis.||percent HbA1c||Standard Error|Least Squares Mean
150495|NCT00384085|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)|Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.|At week 60|Analysis was performed on Intent-To-Treat population which consisted of all patients who were randomized and for whom there was any post-baseline follow-up information. Patients from nonGCP compliant sites were excluded from this analysis. Additional analysis including those patients were completed to ensure that study results were not compromised.||percentage of participants|||Number
150496|NCT00384059|Secondary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N)= number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||titer||95% Confidence Interval|Geometric Mean
150497|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.|During the 4-day period after each dose|Safety population included all participants who received at least 1 dose of vaccine; (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
150498|NCT00384059|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)= number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
150499|NCT00384059|Primary|Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.|Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI.|one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
150500|NCT00384059|Primary|Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate igG antibody concentration to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
150501|NCT00384059|Secondary|Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate antibody concentration/titer to the specific concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
150502|NCT00384059|Primary|Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||EU/mL||95% Confidence Interval|Geometric Mean
150503|NCT00384059|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
150504|NCT00384059|Primary|Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series||one month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||titer||95% Confidence Interval|Geometric Mean
150505|NCT00384059|Secondary|Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.||one month after toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.||Percentage of Participants||95% Confidence Interval|Number
150506|NCT00384059|Secondary|Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.||one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.||Percentage of Participants||95% Confidence Interval|Number
150557|NCT00383240|Primary|Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F|This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)|26-week Treatment Period|All Randomized Subjects||days||Inter-Quartile Range|Median
150507|NCT00384059|Primary|Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.|Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.|One month after infant series dose 2 (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.||Percentage of participants||95% Confidence Interval|Number
150508|NCT00384033|Secondary|Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation|VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||mm||Standard Error|Mean
150509|NCT00384033|Secondary|Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation|COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
150510|NCT00384033|Secondary|Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation|HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
150511|NCT00384033|Secondary|Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
150512|NCT00384033|Secondary|Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation|Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
150513|NCT00384033|Secondary|Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
150514|NCT00384033|Secondary|Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Baseline and Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
150515|NCT00384033|Secondary|Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.|Week 8 or FOT|ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Participants|||Number
150537|NCT00383435|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or~treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population||Participants|||Number
150516|NCT00384033|Primary|Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.|Baseline and Week 8 or FOT|Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.||Units on a Scale||Standard Error|Mean
150517|NCT00383786|Secondary|Able to Identify Biological Markers That Predict Response to Treatment.||10 weeks||||||
150518|NCT00383786|Primary|Changes in CAPS Scores.|"The Clinician-Administered PTSD Scale (CAPS) is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. This is a 17-item core symptom scale, measuring both frequency and intensity of symptoms, with the most frequently used scoring rule is to count a symptom as present if it has a frequency of 1 or more and an intensity of 2 or more. A PTSD diagnosis is made if there is at least 1 B symptom, 3 C symptoms, and 2 D symptoms as well as meeting the other diagnostic criteria. Scores range from 0-136 0 (best possible outcome) to 136 (worst possible outcome). The relevant time-points for reporting change were at baseline and 8 weeks."|Baseline, 8 weeks|20 patients randomized to drug were included in the primary analysis as 2 our of the 22 randomized were excluded because they did not receive a week 1 assessment. 19/25 randomized to placebo were included in the analysis after 6 were excluded due to not receiving week 1 assessments.||scores on a scale||Standard Deviation|Mean
150519|NCT00383760|Secondary|Objective Stable Disease Rate|Objective stable disease rate Using RECIST|Upto 3 years|Data was not collected|||||
150520|NCT00383760|Secondary|Toxicity|Types of Gr 3 or greater adverse events that are atleast possibly related to study drug|All patients will be evaluable for toxicity from the time of their first treatment with E7389.|||Types of adverse event|||Number
150521|NCT00383760|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years|Data were not collected|||||
150522|NCT00383760|Secondary|Time to Progression|Estimated using the Kaplan-Meier method.|At 1 year|Time to progression at 1 year not analyzed|||||
150523|NCT00383760|Secondary|Time to Progression|"Estimated using the Kaplan-Meier method.~Median time to progression"|At 6 months|||months||95% Confidence Interval|Median
150524|NCT00383760|Secondary|Median Time to Disease Progression|Estimated using the Kaplan-Meier method.|Duration of time from start of treatment until the criteria for progression are met, assessed up to 3 years|||months||95% Confidence Interval|Median
150525|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 1 year|||participants|||Number
150526|NCT00383760|Secondary|Overall Survival|Estimated using the Kaplan-Meier method.|At 6 months|||percentage of participants||95% Confidence Interval|Number
150527|NCT00383760|Secondary|Median Survival Time|Estimated using the Kaplan-Meier method.|Up to 3 years|||months||95% Confidence Interval|Median
150528|NCT00383760|Secondary|Stable Disease Rate, Evaluated Using RECIST Criteria|Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years|||percentage of participants||95% Confidence Interval|Number
150529|NCT00383760|Primary|Objective Response (Complete and Partial) Evaluated Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|Up to 3 years|||participants|||Number
150530|NCT00383721|Secondary|Number of Participants With Mild, Moderate, or Severe COPD Exacerbations|"Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more~nebulized treatments/day of inhaled rescue medication. Moderate = treatment with~antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event."|Endpoint (26 weeks)|ITT population||Participants|||Number
150531|NCT00383721|Secondary|Number of Participants With Partly Stable COPD|"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly~average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or treatment-related adverse event as determined by the investigator."|Endpoint (26 weeks)|ITT population||Participants|||Number
150532|NCT00383721|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
150533|NCT00383721|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|"SGRQ consisted of 76 items aggregated into 3 component scores: symptoms~(frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score ranged from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint was the last post-baseline non-missing result through the 26 week evaluation carried forward."|Baseline to Endpoint (26 weeks)|ITT population||Score on a scale||Standard Deviation|Least Squares Mean
150534|NCT00383721|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|ITT population||Liters||Standard Deviation|Least Squares Mean
150538|NCT00383435|Secondary|Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)|Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.|Baseline to Endpoint (26 weeks)|ITT population.||Proportion of symptom-free nights||Standard Deviation|Least Squares Mean
150539|NCT00383435|Secondary|Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score|SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward.|Baseline to Endpoint (26 weeks)|ITT population||Score on a scale||Standard Deviation|Least Squares Mean
150540|NCT00383435|Primary|Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1|"Endpoint was the last post-baseline non-missing result through Week 13 carried~forward."|Baseline to Endpoint (13 weeks)|ITT population||Liters||Standard Deviation|Least Squares Mean
150541|NCT00383435|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.|Baseline to Endpoint (13 weeks)|Intent-to-treat (ITT) population||Liters||Standard Deviation|Least Squares Mean
150542|NCT00383331|Secondary|Overall Survival|Survival time is defined as the time from date of randomization to death due to any cause.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
150543|NCT00383331|Secondary|Time to Treatment Failure|Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
150544|NCT00383331|Secondary|Duration of Response|Duration of response was not analyzed because the trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
150545|NCT00383331|Secondary|Time to Progressive Disease|Time to progressive disease not analyzed because trial was stopped early due to low enrollment.|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
150546|NCT00383331|Secondary|Progression Free Survival|baseline to measured progressive disease|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||months||95% Confidence Interval|Median
150547|NCT00383331|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up|||participants|||Number
150548|NCT00383266|Secondary|Overall Survival (OS)|OS is defined as the time from initiation of treatment to the date of any reason death while those living subjects will be censored at the last assessment date.|Until patient's death (median follow-up 293 days -- range (63-632 days))|||months||95% Confidence Interval|Median
150549|NCT00383266|Secondary|Overall Survival Rate||2 years|||percentage of participants|||Number
150550|NCT00383266|Secondary|Toxicities||30 days following completion of treatment (maximum number of cycles = 6)|||participants|||Number
150551|NCT00383266|Secondary|Overall Survival Rate||1 year|||percentage of participants|||Number
150552|NCT00383266|Secondary|Time to Disease Progression|-Progressive disease=at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|Until patient progresses (median follow-up 293 days -- range (63-632 days)|||months||95% Confidence Interval|Median
150553|NCT00383266|Primary|Overall Response Rate (ORR)|"Overall response rate = complete response (CR) + partial response (PR) using RECIST.~CR=disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level~PR=at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Until patient progresses or dies (median follow-up 293 days -- range (63-632 days)|||percentage of participants|||Number
150554|NCT00383240|Other Pre-specified|Number of Participants With at Least One Severe Asthma Exacerbation|"A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period:~A decrease in FEV1 below the Treatment Period stability limit at any visit,~A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days,~An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication."|Baseline to Week 26|All Randomized Subjects||participants|||Number
150555|NCT00383240|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)|Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.|Baseline to Endpoint|ITT population from the entire 26-week treatment period||Ratio||Standard Deviation|Least Squares Mean
150556|NCT00383240|Secondary|Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).|Baseline to week 26|ITT population with non-missing post-baseline ACQ result||units on a scale||Standard Deviation|Least Squares Mean
150792|NCT00381303|Secondary|Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|ETR Subgroup- Intention to Treat population (ITT)||participants|||Number
150558|NCT00383240|Secondary|Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.|Baseline to Week 26|ITT population with non-missing post-baseline AQLQ result||units on a scale||Standard Deviation|Least Squares Mean
150559|NCT00383240|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF||Baseline to Endpoint (12 weeks)|Intent to Treat (ITT) population||liters x hours||Standard Deviation|Least Squares Mean
150560|NCT00383162|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose. Placebo-23 subjects and Sumatriptan/Naproxen Sodium 54 subjects||Participants|||Number
150561|NCT00383162|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment.“Complete pain/symptom-free” was defined as migraine-free, neck pain-free, and sinus pain free.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150562|NCT00383162|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150563|NCT00383162|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150564|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150565|NCT00383162|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150566|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150567|NCT00383162|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150568|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150569|NCT00383162|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150570|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150571|NCT00383162|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150572|NCT00383162|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150573|NCT00383162|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150614|NCT00383019|Secondary|Number of Subjects With an IOP of <=17 mmHg at Week 8|Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
150574|NCT00383162|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150575|NCT00383162|Secondary|Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|1/2, 1, 4, and 8 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150576|NCT00383162|Secondary|Rescue Medication Used up to 24 Hours Post-dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|Dosing to 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150577|NCT00383162|Secondary|Pain-Free Assessment at 2 Hours Post-dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150578|NCT00383162|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 hours post-dose|Intent-to-Treat (ITT) population included subjects in the Safety Population who provided an evaluation of their Investigational Product (IP) for at least one treated attack.||Participants|||Number
150579|NCT00383149|Secondary|Change From Baseline in FHSI-8 Total Score by Time-point|The FHSI-8 includes eight items representing pancreatic-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. Scoring of the FHSI-8 was to be conducted according to the Functional Assessment of Chronic Illness Therapy (FACIT) manual. The symptom assessment was to include treated participants who had baseline measurement and at least one on-study measurement of FHSI-8 questionnaire.|Baseline, Week 3, Week 6, Week 9, Week 12, Week 12, Week 18, Week 24 and every 3 weeks through end of study (participant death/withdrawal from study)|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, FHSI-8 score data were collected but not summarized.|||||
150580|NCT00383149|Secondary|Percentage of Participants With Baseline Epidermal Growth Factor Receptor (EGFR) Tumor Expression|EGFR expression was evaluated by means of an immunohistochemical assay using tumor tissue collected prior to receiving first dose.|Baseline|Tissue was available for a small proportion of patients and only 1 out of 11 was EGFR positive, hence EFGR expression analysis was not performed.|||||
150581|NCT00383149|Secondary|Number of Participants With Dose Reduction, Dose Delay, or Dose Interruption|Dose reduction of ixabepilone and/or cetuximab due to toxicity was permitted for participants deriving benefit from therapy. Each drug could be dose modified independently of the others. Participants unable to start a cycle due to unacceptable toxicity related to ixabepilone or cetuximab could have therapy delayed for up to 4 weeks. If toxicities prevented the administration of ixabepilone or cetuximab therapy, participants continued receiving the other therapy as scheduled. A dose interruption for ixabepilone or cetuximab was defined as any interruption during the infusion period.|From the first dosing date of Cycle 1 until the last dosing date of the last cycle. Last dosing cycle for a participant was Cycle 21.|Since the combination of ixabepilone and cetuximab tested in this trial failed to meet the primary objective of sufficiently improving 6-month survival rate relative to historical control in participants with metastatic pancreatic cancer, dose modification data were collected but not summarized.|||||
150582|NCT00383149|Secondary|Number of Participants With Hematology, Liver Function, and Renal Laboratory Abnormalities By CTC v3 Grade (Gr)|Laboratory results were graded according to CTC v 3.0. Hematology laboratory evaluations included absolute neutrophil count (ANC), white blood cell count (WBC), platelets (PLT), and hemoglobin (HGB). Liver function laboratory evaluations included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Renal function laboratory evaluation included creatinine.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. n= number of participants with laboratory data available||participants|||Number
150583|NCT00383149|Secondary|Number of Participants With Most Common Treatment-related Nonhematologic AE (>25%) By CTC v3 Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. Acneform rash and peripheral neuropathy were captured by multiple MedDRA preferred terms. Acneform rash included rash, rash pustular, and rash pruritic preferred terms. Peripheral neuropathy included neuromuscular toxicity, peripheral motor neuropathy, and peripheral sensorimotor neuropathy preferred terms.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab.||participants|||Number
150612|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
150793|NCT00381303|Secondary|Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race|Intention to Treat population (ITT)|Week 48|ITT||participants|||Number
150584|NCT00383149|Secondary|Number of Participants With Death Within 30 Days of Last Dose, Any Serious Adverse Event (SAE), Any Adverse Event (AE) Leading to Discontinuation (DC), or Any Treatment-related AEs By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition not necessarily having a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.|From the time of first dose of study drug to ≤30 days after the end of the last dose of study drug or until resolution of study drug-related toxicity.|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. The 53 participants reporting treatment-related AEs included 1 additional participant who also developed Grade 5 viscous intestinal perforation, which was also captured under death within 30 days of last dose category.||participants|||Number
150585|NCT00383149|Secondary|Median Time to Response|Time to response was defined as the number of weeks from first dose of study therapy (ixabepilone or cetuximab) until measurement criteria were first met for PR or CR, whichever status was recorded first. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|Time from first dose of study therapy until first date of PR or CR. Maximum time to response was 19 months.|Response-evaluable participants whose best response was PR or CR.||weeks||Full Range|Median
150586|NCT00383149|Secondary|Median Duration of Response|Duration of response was defined as the number of months from when measurement criteria were first met for CR or PR (whichever was recorded first) until the first date of disease progression or death. Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD.|From first date recorded for CR or PR until the first date of disease progression or death (last participant with tumor response progressed 6.5 months after documented response).|Response-evaluable participants whose best response was PR or CR. Participants without disease progression or death were censored at the last tumor assessment date.||months||95% Confidence Interval|Median
150587|NCT00383149|Secondary|Median Overall Survival Time|Overall survival time was defined as the time in months from the first dosing date to the date of death.|From the first dosing date until death (last reported death was 21 months after first dose).|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without a reported date of death were censored at the last known alive date.||months||95% Confidence Interval|Median
150588|NCT00383149|Secondary|Median Progression Free Survival Time|Progression-Free Survival (PFS) time was defined as the time, in months, from the first dosing date until the date of disease progression or death from any cause.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants without disease progression or death were censored at the last tumor assessment.||months||95% Confidence Interval|Median
150589|NCT00383149|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.||percentage of participants||95% Confidence Interval|Number
150590|NCT00383149|Secondary|Best Overall Tumor Response|Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)= disappearance of all non-target lesions, Partial Response (PR)= at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; Stable Disease (SD)= neither PR nor progressive disease (PD) criteria were met; PD = at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.|From time of first dose of study until 16.49 months (longest period for participant between first dose and documented disease progression)|Response-evaluable participants; all participants with measurable disease who received at least one dose of ixabepilone or cetuximab and who had at least one on-treatment tumor assessment.||participants|||Number
150591|NCT00383149|Primary|Percentage of Participants Surviving at 6 Months|The percentage of participants surviving at 6 months was defined as the number of treated participants who had not died prior to 6 months from the date of their first dose divided by the total number of treated participants.|From time of first dose of study drug through 6 months|Treated participants; all participants who received at least one dose of ixabepilone or cetuximab. Participants who did not die prior to 6 months but dropped out of the study were not included in the numerator.||percentage of participants||95% Confidence Interval|Number
150592|NCT00383123|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)|"SAE: any untoward medical occurrence that~resulted in death,~was life-threatening,~required hospitalization or prolongation of existing hospitalization,~resulted in disability/incapacity, or~was a congenital anomaly/birth defect in the offspring of a study subject.~Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders."|Up to 6 months after vaccination|||subjects|||Number
150593|NCT00383123|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination."|Within 28 days following vaccination|||subjects|||Number
150840|NCT00380861|Secondary|Effect of Subject Demographics and Anthropometrics on ROM||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150594|NCT00383123|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.~Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination."|During a 4-day follow-up period after each vaccination|"Analysis was performed on vaccinated subjects with available data.~Pain, redness, swelling and fever were assessed in all age cohorts.~Drowsiness, irritability and loss of appetite were assessed in the 6 months to < 5 years cohort only.~Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to < 18 years cohort only."||subjects|||Number
150595|NCT00383123|Secondary|Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer|Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to < 5 years and with a baseline titre < 1:40 were analysed for this Outcome Measure.||subjects|||Number
150596|NCT00383123|Secondary|Number of Seroprotected Subjects|Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.|Before (PRE) and 21 or 28 days after (POST) the last vaccine dose|As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom results were available.||subjects|||Number
150597|NCT00383123|Primary|Number of Subjects Reporting Rare Serious Events|"Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:~resulted in death,~was life-threatening,~required hospitalization or prolongation of existing hospitalization,~resulted in disability/incapacity, or~was a congenital anomaly/birth defect in the offspring of a study subject."|Up to 6 months after vaccination|||subjects|||Number
150598|NCT00383123|Primary|Number of Seroconverted Subjects|"Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.~Data are presented for all 3 viral strains comprised in the vaccine."|21 or 28 days after last vaccine dose|As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to < 5 years for whom post-vaccination results were available.||subjects|||Number
150599|NCT00383123|Primary|Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies|GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.|21 or 28 days after last vaccine dose|Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to < 5 years).||Titer||95% Confidence Interval|Geometric Mean
150600|NCT00383110|Secondary|LDL-cholesterol||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||mg/dL||Standard Deviation|Mean
150601|NCT00383110|Secondary|Diastolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||mmHg||Standard Deviation|Mean
150602|NCT00383110|Secondary|Systolic Blood Pressure||12-months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||mmHg||Standard Deviation|Mean
150603|NCT00383110|Primary|Health Care System Distrust Scale|Health Care System Distrust Scale is a valid and reliable 10-item measure of distrust of the health care system, measuring honesty confidentiality and confidence. All questions are measured on a Likert scale, with scores ranging from a minimum of 10 to a maximum of 50. Higher scores indicate more distrust in the health care system.|12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.||units on a scale||Standard Deviation|Mean
150604|NCT00383110|Secondary|Hemoglobin A1c||12 months after enrollment|Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.||% HbA1c||Standard Deviation|Mean
150605|NCT00383110|Primary|General Trust in Physicians Scale (GTIPS)|The GTIPS is a valid and reliable 11-item measure of general trust in physicians in the domains of dependability, confidence, and confidentiality of information. All items are fashioned in a 5-point Likert format with a minimum score of 11 and maximum of 55. Higher scores indicate more trust in physicians.|12 months following enrollment|Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.||units on a scale||Standard Deviation|Mean
150606|NCT00383084|Secondary|Functional Capacity (Higher Scores Indicative of Poorer Functioning)|Fibromyalgia Impact Questionnaire (a higher total score indicates poorer functioning). The range of possible scores is 0 to 100|Baseline and after 12-weeks|||units on a scale||Standard Deviation|Mean
150607|NCT00383084|Secondary|Number of Tender Points on the Body|Number of tender points on physical examination (maximum number is 18)|Baseline and after 12-weeks|||tender points||Standard Deviation|Mean
150608|NCT00383084|Primary|Ambulatory Fatigue, Higher Values Indicate Greater Fatigue|0-100 fatigue ratings, higher scores indicative of greater levels of fatigue|Baseline and after 12-weeks|||units on a scale||Standard Deviation|Mean
150609|NCT00383084|Primary|Ambulatory Pain (Higher Values Indicate Greater Pain)|0 to 100 pain rating, higher numbers indicate greater pain|Baseline and after 12-weeks|||units on a scale||Standard Deviation|Mean
150610|NCT00383071|Primary|Safety of H5N1 Vaccine as Measured by Adverse Events|The number of subjects experiencing adverse events after receiving H5N1 vaccine|Day 28, 56, 84|Primary outcome measure was safety, so below listed numbers are safety population used in AE list.||participants|||Number
150611|NCT00383019|Secondary|Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8|Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
150613|NCT00383019|Secondary|Number of Subjects With an IOP of <=18 mmHg at Week 8|Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
150615|NCT00383019|Secondary|Number of Subjects With an IOP of <=16 mmHg at Week 8|Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
150616|NCT00383019|Secondary|Number of Subjects With an IOP of <=15 mmHg at Week 8|Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8|Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||participants|||Number
150617|NCT00383019|Secondary|Percent Change of IOP From Baseline to Week 8|Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100|Baseline to Week 8|The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4.||percent change||95% Confidence Interval|Least Squares Mean
150618|NCT00383019|Secondary|Change of IOP From Baseline to Week 4|Value at Week 4 minus value at baseline|Baseline to Week 4|ITT||mmHg||95% Confidence Interval|Least Squares Mean
150619|NCT00383019|Primary|Change of Intraocular Pressure (IOP) From Baseline to Week 8|Value at Week 8 minus value at baseline|Baseline to Week 8|The primary efficacy analysis population was the Intent-to-treat population (ITT) which consisted of all subjects treated with the study drug as randomized. If there were any missing IOP values at Week 8, the data were supplemented by LOCF (Last Observation Carried Forward) using data at Week 4.||mmHg||95% Confidence Interval|Least Squares Mean
150620|NCT00382993|Secondary|Recurrence of Any Migraine Headache Pain|Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.|24 hours and 48 hours|Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose.||Participants|||Number
150621|NCT00382993|Secondary|Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. “Complete pain/symptom-free” was defined as migraine-free, neck pain-free, and sinus pain free.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150622|NCT00382993|Secondary|Sustained Complete Pain/Symptom-Free|Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.|2 - 24 hours post-dose|||Participants|||Number
150623|NCT00382993|Secondary|Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.|Baseline, 2, 4, and 8 hours|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150624|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Nausea|Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
150625|NCT00382993|Secondary|Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150626|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Phonophobia|Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
150627|NCT00382993|Secondary|Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had photophobia (sensitivity to light) at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150628|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Photophobia|Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
150629|NCT00382993|Secondary|Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of Participants with neck pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150630|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Neck Pain|Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
150631|NCT00382993|Secondary|Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose|Number of participants who had sinus pain at the time of assessment.|Baseline, 2, 4, and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150632|NCT00382993|Secondary|Sustained Freedom From Migraine-Associated Sinus Pain|Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.|2 - 24 hours post-dose|||Participants|||Number
150633|NCT00382993|Secondary|Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.|2, 4 , and 8 hours post-dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150634|NCT00382993|Secondary|Sustained Freedom From Migraine|Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.|2 - 24 hours post-dose|||Participants|||Number
150841|NCT00380861|Secondary|Single Leg Passive Flexion at All Scheduled Follow-up Visits: 2 Weeks, 6 Weeks, 6 Months and 12 Months.||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150635|NCT00382993|Secondary|Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|0.5, 1, 4, and 8 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150636|NCT00382993|Secondary|Rescue Medication Use During 0 - 24 Hours Post-Dose|A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).|0-24 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150637|NCT00382993|Secondary|Migraine Headache Pain Free at 2 Hours Post-Dose|Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.|2 Hours Post-Dose|ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150638|NCT00382993|Primary|Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose|Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.|2 - 24 Hours Post-Dose|ITT (Intent-to-Treat) Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.||Participants|||Number
150639|NCT00382967|Secondary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.|The numbers represent the number of changes in decisions that the Doctor made in the clinical management of the patient with Clinically Uncertain Parkinsonism||Number of changes in clinical management|||Number
150640|NCT00382967|Primary|Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.|The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.|Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)|||Number of changes in clinical management|||Number
150641|NCT00382928|Secondary|Cerebral Performance at Discharge|"Cerebral Performance Categories/CPC scale:~CPC 1: Good cerebral performance – conscious, alert, able to work, might have mild neurologic or psychological deficit.~CPC 2: Moderate cerebral disability – conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.~CPC 3: Severe cerebral disability – conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.~CPC 4: Coma or vegetative state – any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness.~CPC 5: Brain death – apnea, areflexia, electroencephalogram (EEG) silence, etc."|At discharge|Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.||units on a scale: CPC 1|||Number
150642|NCT00382928|Secondary|Survival to Discharge||At discharge|||participants|||Number
150643|NCT00382928|Secondary|Frequency of Abnormal Rhythms Monitored by the AECD||During the duration of hospital admission on the telemetry ward.|Only the AECD+Standard of Care Group was monitored in this portion of the study.||participants|||Number
150644|NCT00382928|Primary|Number of Participants Without Defibrillation|Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.|10 minutes|"There was only one patient in the Intervention group who received defibrillation.~No patients had CPR or defibrillation in the standard of care group."||participants|||Number
150645|NCT00382863|Secondary|Days Alive Out of Hospital|Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.||days||Full Range|Median
150646|NCT00382863|Secondary|Serious Adverse Events - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events|12 months|Population is intent to treat.||participants|||Number
150647|NCT00382863|Secondary|Participants Experiencing Serious Adverse Events|Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.||participants|||Number
150648|NCT00382863|Secondary|All-Cause Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations|12 months|Population is intent to treat.||participants|||Number
150649|NCT00382863|Secondary|All-Cause Hospitalization|Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.|12 months|Population is intent to treat.||participants|||Number
150650|NCT00382863|Secondary|Heart Failure Hospitalization|Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.|12 months|Population is intent to treat.||participants|||Number
150651|NCT00382863|Secondary|Heart Failure Death - Actuarial Analysis|Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure|12 months|Population is intent to treat.||participants|||Number
150653|NCT00382863|Secondary|Technical Success (Number of Treatment Arm Participants Successfully Implanted)|"Technical success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis."|1 day|Population is as treated, treatment only.||participants|||Number
150654|NCT00382863|Secondary|Change in Left Ventricular End Systolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||centimeters||Full Range|Median
150655|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Diameter|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||centimeters||Full Range|Median
150656|NCT00382863|Secondary|Change in Ejection Fraction|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat.||percent||Full Range|Median
150657|NCT00382863|Secondary|Change in Left Ventricular End Systolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||milliliters||Full Range|Median
150658|NCT00382863|Secondary|Change in Left Ventricular End Diastolic Volume|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||milliliters||Full Range|Median
150659|NCT00382863|Secondary|Heart Failure Hospitalization - Actuarial Analysis|Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment|12 months|Population is intent to treat.||participants|||Number
150660|NCT00382863|Secondary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 12 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 12 months|Population is intent to treat.||participants|||Number
150661|NCT00382863|Secondary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 12 months was at least 45 meters more than at baseline."|baseline to 12 Months|Population is intent to treat||participants|||Number
150662|NCT00382863|Secondary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 12 months as compared to baseline."|baseline to 12 months|Population is intent to treat.||participants|||Number
150663|NCT00382863|Secondary|Change in Left Ventricular Mass|The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.|baseline to 6 months|Population is intent to treat.||grams||Full Range|Median
150664|NCT00382863|Secondary|Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.|baseline to 6 months|Population is intent to treat||score on a scale||Standard Deviation|Mean
150665|NCT00382863|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remained the same as baseline. Improved means the participant's functional class improved (became lower in number) by at least one class. Worsened means the participant's functional class deteriorated (became higher in number) by at least one class."|baseline to 6 months|Population is intent to treat.||participants|||Number
150666|NCT00382863|Primary|Number of Participant Deaths|Total number of participants who died within 12 months of enrollment into the trial.|12 months|The population is intent to treat.||participants|||Number
150667|NCT00382863|Primary|Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score|"A participant was considered a responder if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score."|baseline to 6 months|The population is intent to treat.||participants|||Number
150668|NCT00382863|Primary|Responder Analysis - Six (6) Minute Walk (6MW) Distance|"A participant was considered a responder if 6MW distance at 6 months was at least 45 meters more than at baseline."|Baseline to 6 months|The population is intent to treat.||participants|||Number
150669|NCT00382863|Primary|Responder Analysis - Peak Oxygen Uptake (Peak VO2)|"A participant was considered a responder if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline."|Baseline to 6 months|The population is intent to treat.||participants|||Number
152261|NCT00367835|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 8 weeks|FAS||Participants|||Number
150670|NCT00382785|Primary|Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).|The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.|16 weeks|||Scores on a scale||Standard Error|Mean
150671|NCT00382785|Primary|Scores on the CES-D Scale|The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha >.85) of depression|16 weeks|Same as number of participants analyzed||Scores on a scale||Standard Error|Mean
150672|NCT00382785|Primary|Scores on the Personal Resource Questionnaire 85.|The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at >.90|16 weeks|||Scores on a scale||Standard Error|Mean
150673|NCT00382733|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of disease progression. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Best overall response was assessed after every 8 weeks of treatment and at the end of treatment or time of disease progression, up to 1 year.|All enrolled subjects were analyzed for this outcome.||participants|||Number
150674|NCT00382733|Secondary|Dose Limiting Toxicities (DLT)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. This measure reports the number of subjects who experienced DLT at each dose level during the dose finding portion of the study.|DLTs were assessed during the first cycle of treatment (days 1-28).|Number of participants analyzed refers to those for whom DLT information was available during the dose finding portion of the study.||participants|||Number
150675|NCT00382733|Primary|Maximum Tolerated Dose (MTD) of Single Agent Metronomic Oral Topotecan|The MTD of metronomic oral topotecan was determined using a standard 3+3 dose escalation cohort design. The total sample and the number of subjects who receive each dose in this design depends on the frequency of dose limiting toxicities (DLTs)at each dose level. If 0 out of 3 subjects experience a DLT at a given dose level, 3 subjects will be enrolled at the next higher dose level. If greater than or equal to 2 subjects experience a DLT at a given dose level, dose escalation will be stopped. If 1 out of 3 subjects experience a DLT at a given dose level, 3 subjects are enrolled at the same dose level.|MTD was assessed during the first cycle of treatment (days 1-28).|DLT information was available for 3 subjects who received a topotecan dose of 0.25 mg/day, 3 subjects who received a topotecan dose of 0.50 mg/day, 3 subjects who received a topotecan dose of 0.75 mg/day, 3 subjects who received a topotecan dose of 1.0 mg/day, and 2 subjects who received a topotecan dose of 1.25 mg/day.||mg/day|||Number
150676|NCT00382720|Secondary|Overall Survival (OS)|The number of months measured from the date of randomization to the date of death due to any cause.|up to a maximum of 36 months|248 participants in the full analysis population (FAP).||months||95% Confidence Interval|Median
150677|NCT00382720|Secondary|Best Overall Response Rate (ORR)|"Percentage of partial and complete responses, according to WHO criteria:~Complete Response: Disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.~Partial Response: Decrease by at least 50% of the diameters of all measurable lesions, determined by 2 observations not less than 4 weeks apart."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).||percentage of participants||95% Confidence Interval|Number
150678|NCT00382720|Primary|Time to Progression|"The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause.~WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion."|every 8 weeks up to a maximum of 36 months|248 participants in the full analysis population (FAP).||Months||95% Confidence Interval|Median
150679|NCT00382590|Primary|Number of Participants With Response|Patient response defined by: Death, Resistant to Therapy [no major hematologic improvement using International Myelodysplastic Syndromes (MDS) Working Group (Cheson B, Bennett J, Kantarjian H et al, Blood 2006) criteria after a maximum of 4 courses], or Relapse.|Evaluated every 3 weeks, following 4 courses (16/24 weeks ) and till study end|The analysis was per intention to treat. One participant was inevaluable for response.||Participants|||Number
150680|NCT00382408|Secondary|Number of ADV Type-7 Booster Participants With Increase in Titer|ADV-7 booster effect: is defined as the development of ADV Type-7 neutralizing antibody at Week 4 (Day 26) that represents at least a fourfold increase in titer from baseline (Visit 0) in a subject whose baseline Type-7 titer is ≥1:4.|Baseline to end of Week 8|Subjects undergoing military basic training and randomly assigned to the intent-to-treat (ITT) booster cohort||participants||95% Confidence Interval|Number
150681|NCT00382408|Secondary|Number of ADV Type-4 Booster Participants With Increase in Titer|ADV-4 booster effect: is defined as the development of ADV Type-4 neutralizing antibody at Week 4 (Day 26) that represents at least a fourfold increase in titer from baseline (Visit 0) in a subject whose baseline Type-4 titer is ≥1:4.|Baseline to end of Week 8|Subjects undergoing military basic training and randomly assigned to the intent-to-treat (ITT) booster cohort||participants||95% Confidence Interval|Number
150682|NCT00382408|Primary|Number of Participants With Throat Culture Positive for Wild Type-7 Adenovirus (ADV) Infection|For the oral Type-7 vaccine, seroconversion rates observed at Week 4 (Day 26) for the oral Type-7 ADV vaccine and placebo groups will be calculated. For the purpose of inference, evaluation of reduction in ADV-4 febrile ARD attack rate will be tested first. If the criterion for success is met, then evaluation of ADV-7 seroconversion will proceed.|At Week 4|Subjects undergoing military basic training and randomly assigned to the intent-to-treat (ITT) cohort||participants||95% Confidence Interval|Number
150683|NCT00382408|Primary|Number of Participants With Throat Culture Positive for Wild Type-4 Adenovirus (ADV) Infection|For the oral Type-4 vaccine, the attack rate of the febrile Type-4 ADV-associated ARD cases observed among subjects in the vaccine group and placebo group from the day of study medication administration (Day 0) to the final study visit (Day 56) will be calculated.|At Week 4|Subjects undergoing military basic training and randomly assigned to the intent-to-treat (ITT) cohort||participants||95% Confidence Interval|Number
150684|NCT00382291|Primary|Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score|The CY-BOCS (Scahill et al., 1997) is a semi-structured, clinician rated instrument to measure OCD symptom severity in youth. The CY-BOCS contains a symptom checklist and a severity scale. Through the symptom checklist the clinician assesses current and past experiences of over 60 potential obsessions and compulsions. The Total Score represents the sum of obsession severity and compulsion severity which each consist of five clinician ratings on a Likert scale (range from 0 (none) to 4 (extreme), for time spent, interference, distress, resistance and control over symptoms). Summing of obsession and compulsion severity (range 0-20 on each) produces the Total CY-BOCS score (range 0-40, with 0 representing the best and 40 the worst outcome). Studies have documented good psychometric properties of the CY-BOCS (Gallant et al., 2008; Scahill et al., 1997; Storch et al., 2004).|Measured at Week 18 or End of Study|||units on a scale||Standard Deviation|Mean
150685|NCT00382291|Primary|Clinical Global Impression – Severity of Activation (CGI-SA)|The CGI-SA was adapted from the Clinical Global Impressions – Severity of Illness (CGI-SI) rating (Guy, 1976). The CGI-SI is commonly used in clinical studies of children and adults and has been extensively validated (Zaider et al., 2003). On the CGI-SA clinicians rate the severity of activation symptoms on a range from 0 (no activation) to 7 (extremely severe symptoms, functionally highly impaired and/or extreme distress). We report values representing Median+/-Std Dev for the maximum CGI-SA obtained over the course of study.|Measured at screening, baseline and weekly until end of week 8 after baseline, then monthly for two months and finally at end of study|Per protocol, Intent to treat||units on a scale||Standard Deviation|Median
150686|NCT00382174|Secondary|Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days|Incidence of wound healing at the end of the study, Day 84|Up to 84 days|Analysis was per protocol,ITT, and using LOCF||Number of healed participants|||Number
150687|NCT00382174|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days|All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population|Up to 84 days|||participants|||Number
150688|NCT00382148|Secondary|Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.|Through Week 52|safety-evaluable population||participants|||Number
150689|NCT00382148|Secondary|Food-allergic Reactions As Assessed by the Ewan Scale|"The Ewan scale has five ascending grades of severity from Grade 1 to Grade 5 (as well, there is a possible value of Not Applicable). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator"|Through Week 52|safety-evaluable population||participants|||Number
150690|NCT00382148|Secondary|Food Allergen Exposure, Assessed on Patient-reported Questionnaire|"Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify) and Did you have a reaction? (Yes/No)."|Every 4 weeks through Week 52|||participants|||Number
150691|NCT00382148|Primary|Serious Adverse Events|All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator|Through Week 52|Safety-analysis population||participants|||Number
150692|NCT00382109|Secondary|Chimerism|Evaluate the relative contribution of resistance by ALL blasts to the donor immune response as a cause of relapse post transplantation.|Up to 12 months|We are not able to perform this analysis given the low numbers of blast samples available.|||||
150693|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Pre-Transplantation (MRD)|An event is defined as relapse; relapse risk is reported. Not able to be performed given the low numbers of blast samples available.|At 2 months|The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol. However, we are not able to perform this analysis given the low numbers of blast samples available.|||||
150694|NCT00382109|Secondary|Relative Contribution of ALL Blasts to the Donor Immune Response as a Cause of Relapse Post Transplantation (Correlating Development of aGVHD With Relapse)|An event is defined as relapse; estimated probability of relapse.|At 1 year|Number at risk among no aGVHD and number at risk among aGVHD at 1 year. The two treatment regimens were intended to be analyzed together (combined data), as pre-specified in the study protocol, therefore results are not reported for each Arm of study.||percentage of participants|||Number
150695|NCT00382109|Secondary|Relative Contribution of Resistance by Acute Lymphoblastic Leukemia (ALL) Blasts to Cytolytic Therapy (e.g., Chemotherapy/Irradiation) as a Cause of Relapse Post-transplantation|An event is defined as relapse or transplant-related mortality.|Up to 1 year|We made a large number of xenograft models but were not able to correlate resistance to rapamycin in mice with outcome on the trial with the numbers that we had. For this reason, no specific publications addressing this aim were put forward.|||||
150696|NCT00382109|Secondary|Estimated Rate of Overall Chronic Graft VS Host Disease|Chronic graft vs host disease is defined in APPENDIX III of study protocol.|At 2 years|2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.||percentage of participants||95% Confidence Interval|Number
150697|NCT00382109|Secondary|Estimated Rate of Acute Graft VS Host Disease (GVHD)|Any grade acute graft vs host disease (defined in APPENDIX II study protocol).|At 200 days|2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.||percentage of participants||95% Confidence Interval|Number
150699|NCT00382109|Secondary|Rate of Relapses|An event is defined as relapse.|At 2 years|2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.||percentage of participants||95% Confidence Interval|Number
150700|NCT00382109|Primary|Estimated Percentage of Participants With Event Free Survival|An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.|at 2 years|Two ineligible patients on experimental arm excluded from analysis.||percentage of participants||95% Confidence Interval|Number
150701|NCT00382031|Secondary|Progression Free Survival (PFS)|PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.|From randomization until disease progression or death, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||weeks||95% Confidence Interval|Median
150702|NCT00382031|Secondary|Duration of Response|Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.|Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||month||95% Confidence Interval|Median
150703|NCT00382031|Secondary|Objective Tumor Response|Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|From date of randomization until the date of death from any cause, assessed up to 41 months.|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||participants|||Number
150704|NCT00382031|Primary|Overall Survival|A patient’s overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.|From randomization until death|The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.||months||95% Confidence Interval|Median
150705|NCT00381940|Secondary|Biological Markers|Assessing baseline NF-kB protein levels in tumor tissue|Before, during, and after treatment||||||
150706|NCT00381940|Secondary|Rate of Successful PBSC Harvest|Success is defined as the ability to harvest 2x10^6 CD34+ cells/kg within 5 collection days.|After 2 cycles||||||
150707|NCT00381940|Secondary|Induction Success Rate|Induction success is defined as achieving CR or PR without a targeted primary toxicity.|After 2 cycles and 4 cycles||||||
150708|NCT00381940|Secondary|Overall Response Rate|Overall response includes complete response and partial response.|After 2 cycles and 4 cycles||||||
150709|NCT00381940|Secondary|Toxicity||4 weeks following completion of therapy||||||
150710|NCT00381940|Primary|Complete Response (CR)|CR is defined as at least 80% reduction in the sum of the products of the perpendicular diameters of each of the nodal masses or return to normal size, along with negative nuclear medicine imaging.|After 2 cycles of treatment|Analysis population includes all patients evaluable for tumor response. Three enrolled patients are excluded: 1 ineligible, 1 who was removed from treatment after 1 dose of bortezomib, and 1 who received only 1/3 dose of bortezomib in cycle 1 and part of cycle 2 due to pharmacy error.||participants|||Number
150711|NCT00381888|Secondary|Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.|This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.|Week 4|These patients completed the study and are considered evaluable for this outcome measure.||Participants|||Number
150712|NCT00381888|Primary|Number of Patients With Venous Thromboembolism at Week 4|Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.|Week 4 (Days 28-35)|The number includes those patients who completed the study and are evaluable for this outcome measure.||Participants|||Number
150713|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy||within 5 days of chemotherapy||||||
150714|NCT00381862|Secondary|To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy.||Duration of time patient is on study||||||
150715|NCT00381862|Secondary|Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.||Duration of time the patient is on study||||||
150716|NCT00381862|Secondary|Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy||Duration of time that the patient is on study||||||
150717|NCT00381862|Primary|Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.||Up to 24 weeks|||Participants|||Number
150718|NCT00381849|Primary|Volume of Kidney Stones as Measured on Computerized Tomography|Measurement of kidney stone volume in cubic millimeters.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study.||mm^3||Standard Deviation|Mean
150719|NCT00381849|Primary|Stone Density as Measured by Agatston Score Via Computerized Tomography|Agatston results are a measure of calcium typically used for measuring coronary artery calcification.|Baseline, approximately 52 weeks after baseline|One subject was excluded from CT analysis because of bilateral stone removal surgery during the study||Agatston Score||Standard Deviation|Mean
150721|NCT00381849|Secondary|Change in Stone Burden as Assessed by Radiologist at One Year|Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.|Baseline, approximately 52 weeks after baseline|One subject in the Calcium group was excluded from the CT analysis because of bilateral stone removal surgery during the study.||Kidneys|||Number
150722|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Hydroxyapatite was not analyzed for the Cystine Stone subjects.||KJoules/mol||Standard Deviation|Mean
150723|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|Brushite was not analyzed for the Cystine Stone subjects.||KJoules/mol||Standard Deviation|Mean
150724|NCT00381849|Primary|24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)|Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.|baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment|CaOx was not analyzed for the Cystine Stone subjects.||KJoules/mol||Standard Deviation|Mean
150725|NCT00381810|Primary|Percentage of Participants With at Least 1 Serious Adverse Event|A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.|Baseline to the end of the study (up to 52 weeks)|||Percentage of participants|||Number
150726|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-R2 Expression|The association of VEGF-R2 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-R2 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study||||||
150727|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by VEGF-A Expression|The association of VEGF-A expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with VEGF-A measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study||||||
150728|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Carbonic Anhydrase 9 (CA9) Expression|The association of CA9 expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with CA9 measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study||||||
150729|NCT00381797|Secondary|Progression-free Survival Hazard Ratio by Hypoxia Inducible Factor-2alpha Expression|The association of hypoxia inducible factor-2alpha expression with progression-free survival will be investigated for those strata that have a sufficient number of participants with hypoxia inducible factor-2alpha measurements.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study||||||
150730|NCT00381797|Secondary|Number of Patients With High VEGF-R2 Expression at Baseline|Reported separately for each stratum.|Baseline||||||
150731|NCT00381797|Secondary|Number of Patients With High VEGF-A Expression at Baseline|Reported separately for each stratum.|Baseline||||||
150732|NCT00381797|Secondary|Number of Patients With High Carbonic Anhydrase 9 Expression at Baseline|Reported separately for each stratum.|Baseline||||||
150733|NCT00381797|Secondary|Number of Patients With High Hypoxia Inducible Factor-2alpha Expression at Baseline|Reported separately for each stratum.|Baseline||||||
150734|NCT00381797|Secondary|Correlation of the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline With the Change in Perfusion From Magnetic Resonance Imaging|Spearman correlation coefficient is used to measure the correlation of the changes in VEGF-R2 with the changes in perfusion ratios. The changes are calculated by values at Day 15 minus values at baseline for VEGF-2 in Section 17 above and perfusion in Section 18 above, respectively. The correlation coefficients are reported in each stratum separately.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.||Correlation Coefficient|||Number
150735|NCT00381797|Secondary|Descriptive Statistics for the Change of Perfusion in Magnetic Resonance Imaging Concurrently Measured With the Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC)|The change of perfusion in magnetic resonance imaging is calculated by taking the difference between the Day-15 measurements and the Baseline measurements for patients who had the changes of VEGF-R2. The purpose of reporting the descriptive statistics is to provide the information for the correlation coefficients reported in the next section, Section 19. MR perfusion ratio is the ratio of the perfusion measurements in the tumor and the perfusion measurerement in comparative frontal while matter, which is the comparative healthy part of the brain.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.||Ratio||Standard Error|Mean
150736|NCT00381797|Secondary|Descriptive Statistics for the Changes in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) Concurrently Measured With the Changes in Perfusion From Magnetic Resonance Imaging|The changes in VEGF-R2 are calculated by values at Day 15 minus values at baseline for the patients who had the changes in perfusion from magnetic resonance perfusion imaging. The purpose of reporting descriptive statistics of changes of VEGF-R2 is to provide the information for the correlation coefficients in Section 19.|Baseline and Day 15 (after 2 doses of Bevacizumab) of course 1|The analyses are performed for the patients who had the changes in both VEGF-R2 and perfusion.||Ratio||Standard Error|Mean
150737|NCT00381797|Secondary|Change in Vascular Endothelial Growth Factor Receptor-2 (VEGF-R2) Expression in Peripheral Blood Mononuclear Cells (PBMC) From Baseline to Day-15|The change in VEGF-R2 was calculated from baseline to the time of the 2nd dose (values of 24-48 hours after the 2nd dose at Day 15 - values of pre-dose 1 Day1, i.e., baseline). VEGF-R2 is measured in the relative phosphorylation score which is generated as a ratio of normalized phosphorylated VEGF-R2 versus normalized total VEGF-R2 protein.|Baseline and 24-48 hours after the 2nd dose of Bevacizumab in course 1|||Ratio||Full Range|Median
150738|NCT00381797|Secondary|Terminal Half-life|Blood specimens will be collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens will be analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data will be analyzed to provide an estimate of the terminal half-life. Estimates of the terminal half-life will be reported separately for each stratum.|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1||||||
150739|NCT00381797|Secondary|Systemic Clearance|Blood specimens will be collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens will be analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data will be analyzed to provide an estimate of the systemic clearance. Estimates of the systemic clearance will be reported separately for each stratum.|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1||||||
150740|NCT00381797|Secondary|Volume of Distribution|Blood specimens will be collected on the days listed for pharmacokinetic studies for Bevacizumab. These specimens will be analyzed to produce steady-state plasma Bevacizumab concentration-time data in study participants. The concentration-time data will be analyzed to provide an estimate of the volume of distribution. Estimates of the volume of distribution will be reported separately for each stratum.|Baseline, Course 1 Day 1, Course 1 Day 15, Course 2 Day 1, Course 3 Day 1, Course 4 Day 1, and Course 5 Day 1||||||
150741|NCT00381797|Secondary|Association of Log-transformed Tumor Perfusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor perfusion ratio with progression-free survival will be investigated. Magnetic resonance (MR) perfusion imaging is performed to investigate surrogate markers of tumor growth. Tumor perfusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume perfusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|The analyses cannot be performed with the Cox proportional hazard model since there are no sufficient measurements of perfusion ratio and events.|||||
150742|NCT00381797|Secondary|Association of Log-transformed Tumor Diffusion Ratio With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of tumor diffusion ratios with progression-free survival will be investigated. Magnetic resonance (MR) diffusion imaging is performed to investigate surrogate markers of tumor growth. Tumor diffusion ratios were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. And we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor diffusion ratio. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study|Patients had diffusion ratio at pre-treatment scans and at least one on treatment scans.||Hazard Ratio||95% Confidence Interval|Mean
150743|NCT00381797|Secondary|Association of Log-transformed Volume of Cystic Necrosis With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional Hazards Models, the association of cystic necrosis with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Volumes of cystic necrosis were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on cystic necrosis. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had volume of cystic necrosis at Pre-treatment and at least one on treatment.||Hazard Ratio||95% Confidence Interval|Mean
150788|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)||x10^6 cells/L||Standard Error|Mean
150789|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values|Observed obsevations have no imputation methods applied.|Baseline, Week 48|ITT||x10^6 cells/L||Standard Error|Mean
150744|NCT00381797|Secondary|Association of Log-transformed Tumor Enhancing Volume With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox Proportional hazards Models, the association of Log-transformed tumor enhancing volume with progression-free survival will be investigated. Volumetric magnetic resonance (MR) imaging is performed to investigate surrogate markers of tumor growth. Tumor enhancing volumes were longitudinal. As we are not comparing the strata or study arms, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section and we consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor enhancing volume. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study, OR up to 2 years|Patients had tumor enhancing volume at Pre-treatment and at least one on treatment.||Hazard Ratio||95% Confidence Interval|Mean
150745|NCT00381797|Secondary|Association of Log-transformed Tumor Volume Based on FLAIR With Progression-free Survival (PFS) Using Hazard Ratio Estimates|Using Cox proportional hazards models, the association of tumor volume based on FLAIR images with PFS will be investigated for those strata that have a sufficient number of participants with volume FLAIR measurements. Volumetric magnetic resonance imaging is performed to investigate surrogate markers of tumor growth. Volume FLAIR measurements were longitudinal. As we are not comparing the strata, analyses will be done in each stratum separately, and thus we cannot report the Cox model results in the Statistical Analysis section. We consider these estimates 'descriptive' within each stratum. In this analysis, the hazard ratio is a relative measure of likelihood that a study participant experiences the event of interest compared to another participant who has a one-unit lower Log-transformed tumor volume based on FLAIR. The Cox survival model provides the mean hazard ratio along with its 95% confidence interval, which we report below.|From start of treatment until the earliest of progressive disease, death, second malignancy or off study OR up to 2 years|Patients had Flair volume at Pre-treatment and at least one on treatment.||Hazard Ratio||95% Confidence Interval|Mean
150746|NCT00381797|Secondary|Change in Diffusion Ratio Between the Baseline and Day 15 Brain Image|Diffusion ratio obtained from magnetic resonance (MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the diffusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from diffusion ratio at Baseline to diffusion ratio at Day 15 (values of diffusion ratio at Day 15 -values of diffusion ration at baseline). The higher of diffusion ratio is better. MR diffusion ratio is the diffusion solid part of tumor divided by the diffusion frontal white matter. There is no a unit available.|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm.||Ratio||Full Range|Median
150747|NCT00381797|Secondary|Change in Perfusion Ratio Between the Baseline and Day 15 Brain Imaging|"Perfusion ratio obtained from magnetic resonance(MR) diffusion imaging may explain changes in the tumor after therapy. Changes in the perfusion ratio will be reported for those strata that have a sufficient number of participants with MR diffusion imaging. The change was calculated from perfusion ratio at Baseline to perfusion ratio at Day 15(values of perfusion ratio at Day 15 - values of perfusion ratio at baseline). The higher of perfusion ratio is worse.~MR perfusion ratio is perfusion solid part of tumor from CBV divided by perfusion frontal while matter. There is no a unit available."|Baseline and day 15|There are no sufficient data for the analyses in the Medulloblastoma arm and Ependymoma arm.||Ratio||Full Range|Median
150748|NCT00381797|Secondary|Progression-free Survival|Progression-Free survival is the interval of time between of protocol treatment and minimum date of documentation of progressive Disease,second malignancy,death due to any cause, or date of last follow-up. Progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression,OR the appearance of new tumor OR a > 25% increase in the sum of the products of two longest perpendicular diameters of all measurable tumors. K-M method was used to estimate progression-free survival.|From start of treatment up to 2 years|The patients were treated with any dose treatment.||Months||95% Confidence Interval|Median
150749|NCT00381797|Secondary|Cumulative Incidence of Sustained Objective Responses|Cumulative incidence of sustained objective response provides a percentage of participants experiencing the event of interest at a given follow-up time point (for example, 6-months, 1-year, etc.) in the presence of competing events such as progressive disease or death, and it is estimated using the event data for both the event of interest and the competing events experienced by the study participants. In this sense, it is different than the incidence rates estimated in epidemiological studies in terms of 'incidences per 1000 person years. 6-month Cumulative incidence of sustained objective responses will be reported separately for each stratum.|From the first imaging after treatment up to 2 years|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.||Percentage of Participants|||Number
150750|NCT00381797|Secondary|Number of Study Participants With Grade 3 or 4 Treatment-related Toxicity|Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events. The grade 1 = mild, grade 2=moderate, grade 3 =severe, grade 4=life threatening/disabling, grade 5=death.|From day 1 of treatment until off study|The patients were treated with any dose treatment.||participants|||Number
150751|NCT00381797|Primary|Sustained Disease Stabilization Rate Associated With Bevacizumab and Irinotecan in Patients With Recurrent or Progressive Low-grade Glioma (Stratum E)|Disease stabilization is defined as a complete response(CR) or partial response(PR) observed during the first four courses and sustained for 8 weeks; or stable disease (SD) sustained for 6 courses characterized by SD at the end of course 2, at the end of course 4 and at the end of course 6. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. SD is at least stable and maintenance corticosteroid dose not increased in neurologic examination.|From day 1 of treatment up to 24 weeks|Patients with recurrent or progressive low grade glioma were treated with any courses.||participants||95% Confidence Interval|Number
150790|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA|"The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)~TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards."|Week 48|Etravirine-TMC125 (ETR) Subgroup [TLOVR Non-virologic Failure (VF) Censored]||participants|||Number
150752|NCT00381797|Primary|Objective Response Rate Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response observed during the first four courses of treatment and sustained for 8 weeks. The objective response rate will be reported separately for patients with recurrent/progressive malignant glioma(Stratum A), recurrent/progressive instrinsic brain stem tumors(Stratum B), recurrent/progressive medulloblastoma(Stratum C), and recurrent/progressive ependymoma(Stratum D). CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size. This outcome measures is not defined for the Stratum E in the protocol.|From day 1 of treatment up to 24 weeks|Two patients in the Stratum A,one patient in the Stratum C, and one patient in the Stratum D were inevaluable for this outcome measure.||participants|||Number
150753|NCT00381693|Secondary|Number of Participants With Treatment Related Adverse Events|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.~Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE"|Every 4 weeks during treatment|||Participants|||Number
150754|NCT00381693|Secondary|Time to Progression|Time to progression was defined as the time from registration to progression of disease. Those who die without documentation of disease progression will be considered to have had disease progression at the time of their death unless documented evidence clearly indicates no progression has occured.|up to 3 years|Only 2 out of 10 patients had disease progression. One patient progressed at 0.5 months after registration and one patient progressed at 2.8 months after registration. Thus, median of time to progression and upper limit of 95% confidence interval are not attainable.||months||95% Confidence Interval|Median
150755|NCT00381693|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death due to any cause or time from registration to 3 years after registration if patient is still alive.|From date of registration until death or 3 years after registration if patient is still alive|||months||95% Confidence Interval|Median
150756|NCT00381693|Primary|Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment|"Response Definitions:~Completion Remission (CR):complete resolution of disease-related symptoms, ultrasound-documented resolution of hepastosplenomegaly, normalization of the peripheral blood count, white cell differential, and smear, normalization of bone marrow histology including disappearance of fibrosis and osteosclerosis. Residual cytogenetic abnormalities are allowed.~Partial Remission (PR): a major response in any baseline applicable criteria (except constitutional symptoms) without progression in any other category."|4 months|||participants|||Number
150757|NCT00381628|Primary|The Number of Participants With Blood and Sputum Samples Collected|Blood and sputum samples for general science research collaborators|Baseline|These samples were to be distributed to research collaborators and were not part of a clinical trial. These samples were not analyzed for a specific outcome.||Participants|||Count of Participants
150758|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population.|At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age.|||Percentages of Subjects||95% Confidence Interval|Number
150759|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age|Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age.|At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination.|||Percentages of Subjects||95% Confidence Interval|Number
150760|NCT00381615|Secondary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age|Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age.|1 month after first vaccination|||Ratio||95% Confidence Interval|Geometric Mean
150761|NCT00381615|Primary|Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization.|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination|||Ratio||95% Confidence Interval|Geometric Mean
150762|NCT00381615|Primary|Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ.|Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers.|30 days after the third vaccination|Analysis was performed on the Per Protocol Set (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentage of Subjects||95% Confidence Interval|Number
150791|NCT00381303|Secondary|Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR Non-virologic Failure(VF) Censored||participants|||Number
152901|NCT00361257|Secondary|Changes in Cluster of Differentiation 8 (CD8) Cell Counts (24 Weeks)|The outcome was the 24 week change of CD8 cell counts (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||cells/mm^3||Standard Deviation|Mean
150763|NCT00381615|Primary|Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study|Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
150764|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
150765|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
150766|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set.||Number of subjects|||Number
150767|NCT00381615|Primary|Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups).|Day 1 through day 7 after each vaccination|Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
150768|NCT00381615|Secondary|Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set after booster vaccination.||Percentage of subjects||95% Confidence Interval|Number
150769|NCT00381615|Secondary|Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination|Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age.|30 days after the second vaccination and 1 month after fourth (booster) vaccination|Analysis was performed on the PP set.||ratios||95% Confidence Interval|Geometric Mean
150770|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ|Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population.|pre-first vaccination and 1 month after first vaccination|Analysis was performed on the PP set.||titers||95% Confidence Interval|Geometric Mean
150771|NCT00381615|Secondary|Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age|Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination.|prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination|Analysis was performed on the PP set.||titers||95% Confidence Interval|Geometric Mean
150772|NCT00381615|Primary|Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination of rMenB Vaccine With and Without OMV-NZ|The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the PP set.||titers||95% Confidence Interval|Geometric Mean
150773|NCT00381615|Secondary|Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination|Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination.|1 month after first vaccination|Analysis was performed on the PP set.||Percentage of subjects||95% Confidence Interval|Number
150774|NCT00381615|Primary|Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization|Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age.|Baseline and one month after third-dose of infants series|Analysis was performed on the per protocol (PP) set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis.||Percentage of subjects||95% Confidence Interval|Number
150775|NCT00381550|Primary|Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0||Up to 4 years|||participants|||Number
150776|NCT00381550|Primary|Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation|Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count >500/mm3 and platelets >20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.).|Up to 4 years|||participants|||Number
150777|NCT00381485|Secondary|Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)|Baseline was the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0 = no awakenings to 1 = awakenings every night. The comparison was for MF/F versus placebo. Standard deviation was pooled.|12-week Treatment Period|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Proportion of nights||Standard Deviation|Least Squares Mean
150778|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score|AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The AQLQ(S) Total score was the mean of the individual 32 questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Units on a Scale||Standard Deviation|Least Squares Mean
150779|NCT00381485|Secondary|Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score|ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The ACQ Total score was the mean of the individual seven questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Units on a Scale||Standard Deviation|Least Squares Mean
150780|NCT00381485|Primary|Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)|The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.|Baseline to Week 12|Efficacy analyses were based on randomized subjects with Baseline and any post-baseline data (intent-to-treat principle).||Liter x hour||Standard Deviation|Least Squares Mean
150781|NCT00381381|Primary|CERAD-K|CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.|26 weeks|||Second||Standard Deviation|Mean
150782|NCT00381381|Secondary|GDS-K (Geriatric Depression Scale-Korean) Score After Treatment|GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.|26 weeks|||Units on Scale||Standard Deviation|Mean
150783|NCT00381381|Secondary|Neuropsychiatry Inventory (NPI)|NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.|26 weeks|||Units on Scale||Standard Deviation|Mean
150784|NCT00381381|Primary|CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer’s Disease)|CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).|26 weeks|||Units on Scale||Standard Deviation|Mean
150785|NCT00381303|Secondary|Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF|The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.|Week 48|Etravirine-TMC125 (ETR Subgroup) Intention to Treat population (ITT)||x10^6 Cells/L||Standard Error|Mean
150786|NCT00381303|Primary|Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex|TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.|Week 48|TLOVR non-virologic failure (VF) censored||participants|||Number
150787|NCT00381303|Secondary|Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)|Last Observation Carried Forward (LOCF) imputation method applied.|Week 48|ITT LOCF||x10^6 cells/L||Standard Error|Mean
150794|NCT00381303|Primary|Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex|TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability|Week 48|Intention to Treat (ITT)||participants|||Number
150795|NCT00381095|Secondary|Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28|ECOG - assessed disease progression and how disease affected the daily living abilities of the participant and determined appropriate treatment and prognosis. Graded 0 (fully active able to carry on all pre-disease performance without restrictions) to 5 (dead). Change was day 28 minus baseline.|Baseline, Day 28 or ET|Data not analyzed due to early study termination.||Scores on a scale||Standard Deviation|Mean
150796|NCT00381095|Secondary|Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28|OR-SDS included OR-SDS individual items by dimension of frequency (rarely to almost constantly), severity (slight to very severe), and degree of bother (not at all to very much), number of episodes of retching/vomiting, OR-SDS dimension composite and overall composite scores. Change was scores at occurance minus score at baseline.|Baseline, Day 14, Day 28 or ET|Data not analyzed due to early study termination.||Units on a scale||Standard Deviation|Mean
150797|NCT00381095|Secondary|Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Weeks 2 and 4 or ET|ITT; LOCF; n=number of evaluable participants analyzed at each time point; N= the number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
150798|NCT00381095|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4|HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed; individual symptoms not analyzed||Units on a scale||Standard Deviation|Mean
150799|NCT00381095|Secondary|Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28|IR and SR formulations separately and combined. Change was day x minus baseline.|Baseline, Day 0 through Day 28 or ET|Data not analyzed due to early study termination.||mg/day||Standard Deviation|Mean
150800|NCT00381095|Secondary|Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28|Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.|Baseline, Day 0 through Day 28 or ET|Data no analyzed due to early study termination.||milligrams/day (mg/day)||Standard Deviation|Mean
150801|NCT00381095|Secondary|Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4|Change from baseline in daily average pain score NRS 0 (no pain) to 10 (pain as bad as you can imagine) for pain intensity over past 24 hours recorded every evening before bedtime. Change was week x average minus baseline average.|Baseline, Weeks 1, 2, 3 and 4 or ET|Data not analyzed due to early study termination.||Units on a scale||Standard Deviation|Mean
150802|NCT00381095|Secondary|Change From Baseline in mBPI-sf Interference Index Score at Week 4|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score.|Baseline, Week 4 or ET|ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
150803|NCT00381095|Secondary|Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline.|Baseline, Week 4 or ET|ITT; LOCF= Last observation carried forward; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
150804|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET|ITT; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
150805|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Day 1 to End of Dose Adjustment or ET|ITT; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
150806|NCT00381095|Secondary|DAAC From Baseline in Daily Worst Pain, Days 1 Through 28|DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant’s daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.|Baseline, Days 1 through 28 or ET|ITT; N= number of participants with evaluable data analyzed||Units on a scale||Standard Deviation|Mean
150807|NCT00381095|Primary|Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28|DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.|Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)|Intent-To-Treat population (ITT): all randomized participants for whom at least one post-baseline efficacy evaluation was obtained; N= the number of participants with evaluable data analyzed; n= number of participants with evaluable data at the specific time point.||Units on a scale||Standard Deviation|Mean
150808|NCT00381043|Secondary|% Compliant With Medication|% of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries.|12 weeks|||percentage of participants|||Number
150809|NCT00381043|Secondary|Clinical Global Impression Scale|Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill|12 weeks|||units on a scale||Standard Deviation|Mean
150810|NCT00381043|Secondary|% Heavy Drinking Days During Trial|% of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial.|12 weeks|||percentage of heavy drinking days||Standard Deviation|Mean
150811|NCT00381043|Secondary|Percent With Complete Abstinence|% of subjects with no drinking during the 12 week treatment trial|12 weeks|||percentage of participants|||Number
150812|NCT00381043|Primary|Percent Days Abstinent|%Days without any alcohol consumption over the treatment period|12 weeks|||perecentage||Standard Deviation|Mean
150813|NCT00381043|Primary|% Dropout|Percentage of participants who dropped out of study by drug condition|12 weeks|||percentage of participants|||Number
150814|NCT00381043|Secondary|Retention|Number of individuals retained in the trial by acamprosate vs placebo group|12 weeks|||participants|||Number
150815|NCT00381004|Primary|Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months|||Participants|||Number
150816|NCT00381004|Secondary|Number of Participants Progression-free|Participants progression free as measured at six months following start of treatment. Criteria for Progressive Disease (PD): Peripheral blood: 50% increase in ALC with a level > 10 x 109/L on at least 2 occasions 2 weeks apart. Tumor: An increase of a lesion by 50% over the size present at entry on study or for patients who respond, the size at the time of maximum regression and/or the appearance of new areas of malignant disease. Reappearance of bone marrow disease. A deterioration in performance status or increasing symptoms do not constitute disease progression.|6 months or until disease progression if earlier|||participants|||Number
150817|NCT00381004|Primary|Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.|Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)</=4x10^9/L, Hb>11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC</=4x109/L + Hb>11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease.|Baseline to 6 Months|||Percentage of Participants|||Number
150818|NCT00380978|Secondary|Vomiting|Vomiting during labor analgesia|Vomiting at second analgesia request|||participants|||Number
150819|NCT00380978|Secondary|Neonatal Outcome (APGAR Score < 7 at 5 Minutes)|Infant's Apgar scores measured at 5 minutes of life and were assigned by nurses and pediatricians responsible for neonatal assessment. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing the five values. The categories are skin color, pulse, reflex to stimulation, muscle tome, and breathing. The test was done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 3 and below are generally regarded as critically low, 4 to 6 fairly low, and 7 to 10 generally normal.|APGAR score at 5 minutes|||participants|||Number
150820|NCT00380978|Secondary|Nausea|Participants were asked to rate their nausea (as none, mild, moderate, or severe) and report the presence or absence of vomiting.|At second analgesia request|||participants|||Number
150821|NCT00380978|Secondary|Analgesia Efficacy|Patients were asked to rate their average pain score using an 11-point verbal rating score (VRS)for pain (0 - 10: 0= no pain, 10= worst pain imaginable) between 1st and 2nd analgesia request.|At first and second analgesia requests|||Scores on a scale||Inter-Quartile Range|Median
150822|NCT00380978|Secondary|Indication for Cesarean Delivery|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Number of cesarean deliveries||participants|||Number
150863|NCT00380692|Secondary|Children's Social Behavior Questionnaire (CSBQ) Total Score|CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.||units on a scale||Standard Deviation|Mean
150823|NCT00380978|Secondary|Duration of Labor|Labor was induced by initiating an oxytocin infusion or by infusing extra-amniotic saline followed by oxytocin. All participants had continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol.|Initiation of induction of labor to time of delivery|Per protocol||minutes||Inter-Quartile Range|Median
150824|NCT00380978|Secondary|Instrumented Vaginal Delivery|The decision to proceed to assisted/instrumental delivery was made by the obstetric team for maternal or fetal indications.|At time of decision for delivery|Per protocol - subjects that delivered vaginally||participants|||Number
150825|NCT00380978|Primary|Delivered by Cesarean Section|The decision to proceed to operative delivery was made by the obstetric team for maternal or fetal indications.|Time form initiation of labor analgesia to delivery (up to 24 hours)|Analysis per protocol. 10 did not receive intervention in combined spinal epidural group and 2 in the systemic analgesia group||participants|||Number
150826|NCT00380874|Primary|Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).|Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained; Last Observation Carried Forward (LOCF): last recorded cycle. Primary analysis timeframe: 10 days of paresthesia scores from the onset of chemotherapy to the last cycle of chemotherapy (LOCF).||score on scale||Standard Error|Least Squares Mean
150827|NCT00380874|Secondary|Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms|Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.|Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint|ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||participants|||Number
150828|NCT00380874|Secondary|Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.|Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
150829|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
150830|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9, LOCF cycle endpoint|ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
150831|NCT00380874|Secondary|Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)|Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4–6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).|Baseline to Cycle 9|Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained.||score on scale||Standard Error|Least Squares Mean
150832|NCT00380861|Secondary|Single Leg Active Flexion at 2 Weeks, 6 Weeks, 6 Months and 12 Months.||2 weeks, 6 weeks, 6 months and 12 months||||||
150833|NCT00380861|Primary|Knee Society Passive Flexion at 6 Months|The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.|6 months|||Degrees of passive flexion||Standard Deviation|Mean
150834|NCT00380861|Secondary|Subject Satisfaction||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150835|NCT00380861|Secondary|Crepitus||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150836|NCT00380861|Secondary|Ability to Perform Activities||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150837|NCT00380861|Secondary|Knee Pain||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150838|NCT00380861|Secondary|KOOS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150839|NCT00380861|Secondary|AKS Score||Pre-operative, 2 and 6 weeks and 6 and 12 months follow up||||||
150842|NCT00380718|Secondary|Time to Tumor Progression|Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.||months||95% Confidence Interval|Median
150843|NCT00380718|Secondary|Time to Treatment Failure|Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. One patient was censored as he/she was alive at time of analysis.||months||95% Confidence Interval|Median
150844|NCT00380718|Secondary|Duration of Response|Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Participants who received study drug and who had either a complete or partial response to treatment. Three participants were censored as they were alive at the time of analysis.||months||Full Range|Median
150845|NCT00380718|Secondary|Progression-Free Survival (PFS)|Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.|baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.||months||95% Confidence Interval|Median
150846|NCT00380718|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.|baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment)|Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.||months||Full Range|Median
150847|NCT00380718|Secondary|Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])|DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."||proportion of participants||95% Confidence Interval|Mean
150848|NCT00380718|Primary|Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])|"The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)|"Number of participants who received at least one dose of study drug. Participants who were classified as Unknown were considered nonresponders rather than missing."||proportion of responders||95% Confidence Interval|Mean
150849|NCT00380692|Secondary|Cytochrome P450 2D6 Genotype|Genotype characterization was used to determine participants' metabolic status.|baseline|All randomized participants.||participants|||Number
150850|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times|Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
150864|NCT00380692|Secondary|Aberrant Behavior Checklist (ABC)|The ABC is a 58-item informant-based scale comprised of five subscales (Irritability [15 items], Lethargy [16], Stereotypic Behaviors [7], Hyperactivity [16], Inappropriate Speech [4]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12).|Baseline, 8 weeks, 28 weeks|Randomized participants with values at timepoint.||units on a scale||Standard Deviation|Mean
150851|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates|Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively.|Baseline, 8 weeks|Number of participants with baseline and one non-missing postbaseline value at visit.||error rate (percentages)||Standard Deviation|Mean
150852|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates|Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||error rate (percentage)||Standard Deviation|Mean
150853|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement|A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.||millimeters||Standard Deviation|Mean
150854|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy|A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target.|Baseline, 8 weeks|Number of participants with baseline and non-missing postbaseline value at visit.||millimeters||Standard Deviation|Mean
150855|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #14. Standard deviations of reaction times (RT) assess intraindividual variability in RT referring to the two conditions creating hits and correct rejections as mentioned in Outcome Measure #14.|Baseline, 8 weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
150856|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections|Memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to remember (one animal). A “yes” is required whenever the target is part of displayed set of 4 animals. Load 2 has 2 animals. A “yes” is required whenever one of the animals appears in successively displayed sets of 4 animals. Targets are present in 50% of the trials. Reaction time (RT) for hits is mean RT of correct “yes” responses to targets. RT correct rejections are mean RTs of correct “no” responses when target was missing.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
150857|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates|The memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to identify (e.g., an animal). A “yes” is required whenever the target is part of the displayed set of four stimuli (all animals). Load 2 has 2 targets. Whenever 1 of the targets appears in the successively displayed sets of four animals, a “yes” is required. Targets are present in 50% of trials. Error rates are the percentages of errors made in each task condition, based on the number of errors/total number of trials X 100.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||error rate (percentage)||Standard Deviation|Mean
150858|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
150859|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections|Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||milliseconds||Standard Deviation|Mean
150860|NCT00380692|Secondary|Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates|Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses “yes” when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses “no” when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100.|Baseline, 8 Weeks|Number of participants with baseline and a non-missing postbaseline value at visit.||error rate (percentage)||Standard Deviation|Mean
150861|NCT00380692|Secondary|Nijmeegse Ouderlijke Stress Index (NOSI) Total Score|The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.||units on a scale||Standard Deviation|Mean
150862|NCT00380692|Secondary|General Health Questionnaire (GHQ) Total Score|Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress.|Baseline, 8 weeks, 28 weeks|Randomized participants with value at timepoint.||units on a scale||Standard Deviation|Mean
150865|NCT00380692|Secondary|Sleep Measure Scale|10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 [0-15 minutes] to 5 [>1 hour]); Total hours (numbers associated with hours of sleep).|Baseline, 8 weeks, 28 weeks|Randomized participants with a value at timepoint.||units on a scale||Standard Deviation|Mean
150866|NCT00380692|Secondary|ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|28 weeks|Randomized participants with a value at timepoint.||units on a scale||Standard Deviation|Mean
150867|NCT00380692|Secondary|Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 8 weeks, 28 weeks|Number of randomized participants who had a value at timepoint.||units on a scale||Standard Deviation|Mean
150868|NCT00380692|Secondary|Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|8 weeks, 28 weeks|Number of randomized participants with values at timepoint.||units on a scale||Standard Deviation|Mean
150869|NCT00380692|Primary|ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline and 8 weeks|Number of randomized participants with a value at baseline and 8 week endpoint. Last Observation Carried Forward analysis.||units on a scale||Standard Deviation|Mean
150870|NCT00380588|Other Pre-specified|Survival Time|Data of patients lost to follow-up were censored at the last date of confirmation of their survival.|baseline to date of death due to any cause (up to 2 years)|||months||95% Confidence Interval|Median
150871|NCT00380588|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.||months||95% Confidence Interval|Median
150872|NCT00380588|Secondary|Tumor Response|"Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years)|Number of patients who received at least one dose of study drug.||participants|||Number
150873|NCT00380588|Primary|Percentage of Patients Alive at 1 Year (1-Year Survival Rate)|Percentage of patients alive at 1 year.|1 year|Number of patients who received at least one dose of study drug.||percentage of participants|||Number
150874|NCT00380367|Primary|Percentage of Subjects Who Serologically Convert to Each of Human Papilloma Virus (HPV) 6, 11, 16, 18 at Week 4 Postdose 3 (Month 7)|Month 7 HPV cLIA seroconversion rates among subjects who received Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) L 1 VLP vaccine (per‐protocol immunogenicity population ).|7 months|The number of subjects contributing to the analysis includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant Human Papilloma Virus (HPV) type(s), and had a Month 7 serum sample collected within an acceptable day range.||Percentage of subjects||95% Confidence Interval|Mean
150875|NCT00380367|Secondary|Injection Site Adverse Experiences (AE), and Any Adverse Experiences (AE) That Occur Throughout the Study||7 months|Only the subjects who had safety follow‐up data were included in the safety summaries.||Subjects|||Number
150876|NCT00380250|Secondary|Month 3 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|||Scale Score||Standard Deviation|Mean
150877|NCT00380250|Secondary|Month 2 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|||Scale Score||Standard Deviation|Mean
150878|NCT00380250|Secondary|Month 1 Abdominal Pain Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|||Scale Score||Standard Deviation|Mean
150879|NCT00380250|Secondary|Month 3 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 3|ITT, with LOCF||BM/week||Standard Deviation|Mean
150880|NCT00380250|Secondary|Month 2 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 2|ITT, with LOCF||BM/week||Standard Deviation|Mean
150881|NCT00380250|Secondary|Month 1 Bowel Movement Frequency Rates Change From Baseline||Change from baseline for month 1|ITT, with LOCF||BM/week||Standard Deviation|Mean
150882|NCT00380250|Secondary|Month 1 Abdominal Bloating Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
150883|NCT00380250|Secondary|Month 3 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
150884|NCT00380250|Secondary|Month 2 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
150885|NCT00380250|Secondary|Month 3 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 3|ITT with LOCF||Scale score||Standard Deviation|Mean
150886|NCT00380250|Secondary|Month 2 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 2|ITT with LOCF||Scale score||Standard Deviation|Mean
150895|NCT00380250|Secondary|Month 1 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse."|month 1 (28 days)|ITT without LOCF||percent of participants|||Number
150896|NCT00380250|Secondary|Month 3 Responder Rate|"Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND:~Rescue medication use does not increase during the month as compared to baseline;~No discontinuation during the month due to lack of efficacy;AND~No ratings during the month of Moderately worse or Significantly worse."|month 3 (28 days)|ITT without LOCF||percent of participants|||Number
150897|NCT00380250|Secondary|Month 2 Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month."|month 2 (28 days)|ITT without LOCF||percent of participants|||Number
150898|NCT00380250|Primary|Overall Responder Rate|"Monthly responder: >=Moderately relieved symptoms 4 weeks/month or Significantly relieved >= 2 weeks/month IF:~Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.~Overall responder: responder for at least 2/3 months"|12 weeks|Intent-to-treat (ITT) without Last Observation Carried Forward (LOCF)||percentage of participants|||Number
150899|NCT00380250|Secondary|Quality of Life Change From Baseline|Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase|Change from baseline at 12 weeks|ITT without LOCF||Scale score||Standard Deviation|Mean
150900|NCT00380250|Secondary|Month 1 Symptom Relief|Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
150901|NCT00380250|Secondary|Month 1 Constipation Severity Change From Baseline|0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline at 28 days|ITT with LOCF||Scale score||Standard Deviation|Mean
150902|NCT00380250|Secondary|Month 1 Bowel Straining Change From Baseline|0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
150903|NCT00380250|Secondary|Month 1 Stool Consistency Change From Baseline|0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)|Change from baseline for month 1|ITT with LOCF||Scale score||Standard Deviation|Mean
150904|NCT00380250|Secondary|Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline|SBMs are any bowel movement not associated with rescue medication use.|Change from baseline for month 1|ITT with LOCF||SBM/week||Standard Deviation|Mean
150905|NCT00380081|Post-Hoc|Subjective Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as documented by the participant for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population||number of awakenings||95% Confidence Interval|Least Squares Mean
150906|NCT00380081|Secondary|Polysomnography Number of Awakenings After Middle-of-the-Night Awakening|Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||number of awakenings||95% Confidence Interval|Least Squares Mean
150907|NCT00380081|Secondary|Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
150908|NCT00380081|Secondary|Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening|Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
150909|NCT00380081|Secondary|Subjective Sleep Onset Latency After Middle-of-the-Night Awakening|Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
150910|NCT00380081|Secondary|Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening|Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent to treat population||percentage of time asleep||95% Confidence Interval|Least Squares Mean
150911|NCT00380081|Secondary|Subjective Ability to Function|Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population||percentage of participants|||Number
150912|NCT00380081|Secondary|Subjective Level of Refreshed Sleep|Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population||percentage of participants|||Number
150913|NCT00380081|Secondary|Subjective Sleep Quality Rating|Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.|Days 1 and 2 for each treatment|Intent to treat population||percentage of participants|||Number
150914|NCT00380081|Other Pre-specified|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
150915|NCT00380081|Secondary|Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening|The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
150916|NCT00380081|Other Pre-specified|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.|Days 1 and 2 for each treatment|Intent to treat population||minutes||95% Confidence Interval|Least Squares Mean
150917|NCT00380081|Secondary|Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography|Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population.||minutes||95% Confidence Interval|Least Squares Mean
150918|NCT00380081|Secondary|Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.|Days 1 and 2 for each treatment|Intent to treat population||participants|||Number
150919|NCT00380081|Primary|Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography|Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.|Days 1 and 2 for each treatment|Intent-to-treat population||minutes||95% Confidence Interval|Least Squares Mean
150920|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
150921|NCT00380068|Secondary|Long-term Survival|Defined as not dying during study participation|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
150922|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 48|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.||Percentage of participants|||Number
150923|NCT00380068|Secondary|Monotherapy Treatment Status|Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment|Baseline to Week 24|Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline.||Percentage of participants|||Number
150924|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 48|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
150925|NCT00380068|Secondary|Failure-free Treatment Status|Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents|Baseline to Week 24|Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
150926|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of PH at Week 48|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 48|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
150927|NCT00380068|Secondary|Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24|Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents|Baseline to Week 24|Full analysis set. Participants who were lost to follow-up were censored at the date of last contact.||Percentage of participants|||Number
150928|NCT00380068|Secondary|Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10.|Baseline to Week 48|Full Analysis Set. Last Observation Carried forward. 25 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.||Units on a scale||Standard Deviation|Mean
150944|NCT00379899|Secondary|Change From Baseline of the Progression of AVC.|Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Units on a scale||Standard Error|Mean
156154|NCT00325468|Primary|Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||95% Confidence Interval|Least Squares Mean
150929|NCT00380068|Secondary|Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale|Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 26 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data.||Units on a scale||Standard Deviation|Mean
150930|NCT00380068|Secondary|Change From Baseline to Week 48 in WHO Functional Class|Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 48|Full Analysis Set. Observed Data. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.||Percentage of participants|||Number
150931|NCT00380068|Secondary|Change From Baseline to Week 24 in WHO Functional Class|Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.|Baseline to Week 24|Full Analysis Set. Last Observation Carried Forward. 3 participants were not analyzed due to lack of post-baseline WHO functional class data.||Percentage of participants|||Number
150932|NCT00380068|Secondary|Percent Change From Baseline to Week 48 in BNP||Baseline to Week 48|Full Analysis Set. Observed data. 111 participants were excluded from the analysis due to lack of baseline or Week 48 BNP data.||Percent change in BNP||95% Confidence Interval|Geometric Mean
150933|NCT00380068|Secondary|Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 10 participants were excluded from the analysis due to lack of baseline or post-baseline BNP data.||Percent change in BNP||95% Confidence Interval|Geometric Mean
150934|NCT00380068|Secondary|Change From Baseline to Week 48 in Borg Dyspnea Index|Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 48|Full Analysis Set. Observed data. 114 participants were excluded from the analysis due to lack of Week 48 Borg Dyspnea Index data.||Units on a scale||Standard Deviation|Mean
150935|NCT00380068|Secondary|Change From Baseline to Week 24 in Borg Dyspnea Index|Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.|Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline Borg Dyspnea Index data.||Units on a scale||Standard Deviation|Mean
150936|NCT00380068|Primary|Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)||Baseline to Week 24|Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline 6MWD data.||meters||Standard Deviation|Mean
150937|NCT00379899|Secondary|Percent Change in Ca x P|Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
150938|NCT00379899|Secondary|Absolute Change in Ca x P|Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||(mg/dL)2||Standard Error|Mean
150939|NCT00379899|Secondary|Percent Change in Phosphorus|Percent change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
150940|NCT00379899|Secondary|Absolute Change in Phosphorus|Absolute change from baseline in serum phosphorus to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||mg/dL||Standard Error|Mean
150941|NCT00379899|Secondary|Percent Change in Calcium|Percent change from baseline in corrected serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
150942|NCT00379899|Secondary|Absolute Change in Calcium|Absolute change from baseline in serum calcium to weeks 44 through 52|Baseline and Weeks 44 through 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||mg/dL||Standard Error|Mean
150943|NCT00379899|Secondary|Percent Change in PTH|Percent change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Percentage||Standard Error|Mean
150945|NCT00379899|Secondary|Change From Baseline in AC Score|Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Units on a scale||Standard Error|Mean
150946|NCT00379899|Secondary|Absolute Change in PTH|Absolute change from baseline in intact Parathyroid Hormone (iPTH)|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||pg/mL||Standard Error|Mean
150947|NCT00379899|Secondary|Number of Participants Achieving > 15% Progression of CAC.|Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52|52 weeks|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Participants|||Number
150948|NCT00379899|Primary|Percent Change From Baseline in CAC Score|Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.|Baseline and Week 52|Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score||Units on a scale||Standard Error|Mean
150949|NCT00379834|Primary|Diurnal Intraocular Pressure Control|Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)|12 months|Selected by level funding available||millimeters of mercury||Standard Deviation|Mean
150950|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Maximum Concentration (Cmax)|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Cmax in nanograms per milliliter (ng/mL).|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.||ng/mL chloroquine||95% Confidence Interval|Median
150951|NCT00379821|Secondary|Pharmacokinetics of Chloroquine Represented by Time of Maximal Concentration (Tmax) and Chloroquine Half-life|1727 non-zero concentration measurements from 479 participants were pooled and used for population pharmacokinetic modeling in Monolix413s. Compartmental population pharmacokinetic modeling was used due to highly sparse data. The model was parameterized in terms of absorption rate constant for chloroquine (Ka), apparent clearance for chloroquine (CL/F, with F as the unknown oral bioavailability), apparent volume of distribution of the central and peripheral compartments for chloroquine (Vd/F), and the inter-compartmental clearance for chloroquine (Q/F). Only these primary population pharmacokinetic parameters could be estimated using the type of data collected. The best-fit population PK model was then used to estimate individual parameter estimates to derive Tmax and half-life.|Day 0 - Day 28|All participants with non-zero concentration measures suitable for pharmacokinetic analysis were included.||Hours||95% Confidence Interval|Median
150952|NCT00379821|Secondary|Nearest Neighbor Index as a Measure of Spatial Pattern of the Distribution of Malaria Cases in Ndirande|The Global Positioning System (GPS) was used to establish the coordinates of participants' homes. The distribution of these coordinates was analyzed for evidence of clustering, or occurring closer together than would be expected on the basis of chance. Nearest Neighbor Index is a ratio of the observed mean distance over the expected mean distance. If the index is less than 1, the pattern exhibits clustering. If the index is greater than 1, the trend is toward dispersion.|1 year|The analysis included all participants for whom the GPS coordinates of the home were established.||Index|||Number
150953|NCT00379821|Secondary|Time to First Malaria Episode in Participants Who Travelled and Slept Outside the City Versus Those Who Did Not Travel and Sleep Outside the City.|The cumulative hazard of having a malaria attack within one year for those participants who travelled and slept in rural areas (outside the city) versus those who did not was calculated and is presented as a life table to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point. Participants are right-censored at the time of first malaria episode. Participants who did not develop malaria during follow-up or were lost to follow-up were censored at the time of their last visit.|Days 0 - 420|||participants|||Number
150954|NCT00379821|Secondary|Number of Participants With New and Recrudescent Infections After Subsequent New Episodes|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, participants who subsequently suffered new malaria episodes were monitored for the additional occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|Day 28 to 1 year|The analysis population is limited to participants who had new episodes of malaria during the follow-up period after treatment.||participants|||Number
150955|NCT00379821|Secondary|Number of Participants With New and Recrudescent Malaria Infections After Initial Treatment|Participants were enrolled at the time of initial malaria episode and treated. Subsequent to treatment, subjects were monitored for the occurrence of new and recrudescent malaria infections, which were distinguished by analysis of the infecting parasites using merozoite surface protein-2 polymorphic gene length variation.|28 days to 1 year|All subjects completing the initial treatment were included in the analysis population.||participants|||Number
150956|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T at Recrudescent Episodes of Malaria|Participants were enrolled in the study at the time of the initial episode of malaria. If the participant presented with a subsequent episode of malaria at any time during the one year of follow-up, the presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Recrudescent episodes of malaria within one year of enrollment|The analysis population is limited to participants who presented with subsequent episodes of malaria from whom samples were successfully collected and DNA successfully amplified.||participants|||Number
150957|NCT00379821|Secondary|Number of Participants Infected With Parasites With the Mutation Pfcrt 76T on Day 0 of the Initial Episode of Malaria|The presence of parasites with the mutation pfCRT 76T was measured with filter paper specimens collected at the time of enrollment and with successful parasite DNA amplification using pyrosequencing.|Day 0 of initial episode of malaria|All participants from whom samples were successfully collected and DNA successfully amplified were included.||participants|||Number
150958|NCT00379821|Secondary|Number of Participants in Each Treatment Arm Who Change From “Normal” to “Abnormal” on Any Questions of the Neurological Examination|"A basic age-appropriate neurological examination was conducted on Day 28 of each malaria illness episode and also at Days 112 and 224, and at 1 year. Subjects were were counted as a change from 'normal' to 'abnormal'  if they had the 'normal' (or not-applicable) response for the initial day 28 exam and an 'abnormal' response at their last exam. If a subject did not have an exam at 1 year then the last available exam that was not associated with an illness episode (either Day 112 or 224) was used."|1 Year|Subjects who did not have an initial exam, or who did not have a subsequent exam at a routine visit are excluded.||Participants|||Number
150959|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150960|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150961|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150962|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150963|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150964|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150965|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150966|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150967|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150968|NCT00379821|Secondary|Mean Alanine Transaminase (ALT) in Each Treatment Arm (Hepatic Function)|ALT values were assessed from blood draws at Day 0 and Day 14 of each malaria episode.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||International Units/Liter||95% Confidence Interval|Mean
150969|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150970|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of fourth subsequent malaria episode (Episode 4)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150971|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150972|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of third subsequent malaria episode (Episode 3)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150973|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150974|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of second subsequent malaria episode (Episode 2)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150975|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150976|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of first subsequent malaria episode (Episode 1)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150977|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 14 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150978|NCT00379821|Secondary|Mean Creatinine in Each Treatment Arm (Renal Function)|Creatine values were assessed from blood draws at Day 0 and Day 14 of each malaria episode. Samples that were below the limit of detection were reported as 44.2 micromoles/liter, equivalent to the lower limit of detection.|Day 0 of initial malaria episode (Episode 0)|The safety population includes all participants who have laboratory results reported at the time point for the episode.||Micromole/Liter||95% Confidence Interval|Mean
150979|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants Greater Than 3 Years to 5 Years of Age.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.||Grams/Deciliter||95% Confidence Interval|Mean
150980|NCT00379821|Secondary|Mean Hemoglobin at the Last Study Visit in Each Treatment Arm for the Age Group of Participants 3 Years of Age or Younger.|Hemoglobin values were assessed from blood collected at the last study visit at one year after enrollment. Group means are stratified by participants 3 years of age and under, and over 3 to 5 years of age.|1 year|The safety population includes all participants. The number of participants is limited to those who attended the final 1-year visit.||Grams/Deciliter||95% Confidence Interval|Mean
150981|NCT00379821|Secondary|Number of Cases of Severe Malaria in Each Treatment Arm|A case of severe malaria included one or more of the following: Hemoglobin ≤5 g/dL; prostration; respiratory distress; bleeding; recent seizures, coma or obtundation (Blantyre coma score < 5); inability to drink, or persistent vomiting. All cases were then adjudicated by a panel of investigators prior to analysis.|1 Year|The safety cohort includes all participants.||Cases of severe malaria|||Number
150982|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of fourth subsequent malaria episode (Episode 4)|This analysis was per protocol, which includes participants who had 4 subsequent malaria episodes, but excludes participants if the fourth episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the fourth episode.||Participants|||Number
150983|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of third subsequent malaria episode (Episode 3)|This analysis was per protocol, which includes participants who had at least 3 subsequent malaria episodes, but excludes participants if the third episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the third episode.||Participants|||Number
150984|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of second subsequent malaria episode (Episode 2)|This analysis was per protocol, which which includes participants who had at least 2 subsequent malaria episodes, but excludes participants if the second episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the second episode.||Participants|||Number
150985|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of first subsequent malaria episode (Episode 1)|This analysis was per protocol, which includes participants who had at least 1 subsequent malaria episode, but excludes participants who did if that episode was not caused by p. falciparum or if the participant did not receive all 3 doses of treatment for the first subsequent episode.||Participants|||Number
150986|NCT00379821|Secondary|Number of Participants With Day 28 Adequate Clinical and Parasitologic Response in Each Treatment Arm|Adequate clinical and parasitologic response (ACPR) was defined as the absence of parasitemia at Day 28 and without previously meeting any of the criteria of early treatment or late clinical failure.|Day 28 of initial malaria episode (Episode 0)|This analysis was per protocol, which excludes participants who did not have p. falciparum or who did not receive all 3 doses of treatment.||Participants|||Number
150987|NCT00379821|Primary|Number of Clinical Malaria Episodes Per Year of Follow-up|Clinical malaria episode was defined as at least one symptom of malaria and a positive malaria smear. The number of clinical malaria episodes (not including the initial malaria episode) reported by participants during follow up is presented as the number per Person Years at Risk (PYAR).|1 year|The intention to treat (ITT) population was used for the primary outcome.||Episodes per PYAR|||Number
150988|NCT00379808|Other Pre-specified|Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)|biomarker determined by enzyme-linked immunosorbant assay.|1 month|those completing the entire study||pg/ml||Inter-Quartile Range|Median
150989|NCT00379808|Other Pre-specified|Interleukin 1 Receptor Antagonist (IL1ra)|IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)|1 month|all participants who completed the entire study||pg/ml||Inter-Quartile Range|Median
150990|NCT00379808|Other Pre-specified|Monocyte Chemotactic Protein-1 (MCP-1)|biomarker was measured by enzyme-linked immunosorbant assay (ELISA)|1 month|those who completed the entire study||pg/ml||Inter-Quartile Range|Median
150991|NCT00379808|Other Pre-specified|Triglycerides|measured by a clinical laboratory; Quest Laboratories|1 month|those completing the entire study||mg/dl||Inter-Quartile Range|Median
150992|NCT00379808|Secondary|High Density Lipoprotein (HDL)-Cholesterol|Lipid levels were determined at a clinical laboratory (Quest Diagnostics)|1 month|those completing entire study||mg/dl||Inter-Quartile Range|Median
150993|NCT00379808|Primary|High-sensitivity C-reactive Protein|measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)|1 month|based on patients who completed the entire study||mg/dl||Inter-Quartile Range|Median
150994|NCT00379795|Primary|Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24|Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.|Month 12 and 24|"Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by n"||participants|||Number
150995|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 12 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||letters||Standard Deviation|Mean
150996|NCT00379795|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters|Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.|Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24|"Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."||letters||Standard Deviation|Mean
150997|NCT00379795|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.~Additional information about adverse events can be found in the adverse events section."|36 months|Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.||participants|||Number
150998|NCT00379795|Primary|Number of Participants With Ocular Adverse Events|"Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|36 months|All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.||participants|||Number
150999|NCT00379769|Secondary|Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151000|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||bone fracture events|||Number
151001|NCT00379769|Secondary|Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||bone fracture events|||Number
151002|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up|"The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included Unknown as a category. Fracture events with missing outcome data were reported as Data unavailable."|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151003|NCT00379769|Secondary|Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151004|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151005|NCT00379769|Secondary|Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151045|NCT00379769|Secondary|Number of Participants With Addition of Third Oral Agent/Switch to Insulin|The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151006|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151007|NCT00379769|Secondary|Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151008|NCT00379769|Secondary|Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151009|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151010|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined|The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151011|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event – Overall and by Gender: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151115|NCT00378378|Secondary|Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine|The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).|Baseline to Endpoint|||mcg/hour||Standard Deviation|Least Squares Mean
151012|NCT00379769|Secondary|Number of Participants With a Bone Fracture Event – Overall and by Gender: Main Study and Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151013|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151014|NCT00379769|Secondary|Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151015|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151016|NCT00379769|Secondary|Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined|The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151033|NCT00379769|Secondary|Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||U/L (Units/Liter)||95% Confidence Interval|Mean
152902|NCT00361257|Secondary|Changes in Cluster of Differentiation 4 (CD4) Cell Counts (24 Weeks)|The outcome was the 24 week change in CD4 cell count (week 24-baseline).|At baseline and weeks 24|The analysis was based on observed data.||cells/mm^3||Standard Deviation|Mean
151017|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)|Observational Follow-up Population: all participants from the ITT Population of the RECORD study who provided data during the observational follow-up. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151018|NCT00379769|Secondary|Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined|The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.|From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)|ITT Population. Analyses were performed by the original randomized treatment in the main RECORD study (referred to as Combined RSG and Combined MET/SU).||participants|||Number
151019|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151020|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151021|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151022|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions|The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme >= 2x the ULN or CK > 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151023|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions|The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151034|NCT00379769|Secondary|Model Adjusted Change From Baseline in Body Weight at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||kilograms||Standard Error|Mean
151024|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions|"The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as unknown deaths, but were counted as CV deaths for the analysis of this endpoint."|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151025|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions|Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151026|NCT00379769|Primary|Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions|IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151027|NCT00379769|Primary|Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause|All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151028|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151029|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151030|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151031|NCT00379769|Secondary|Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||mmHg (millimeters of mercury)||Standard Error|Mean
151032|NCT00379769|Secondary|Model Adjusted Change From Baseline in Waist Circumference at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||cm (centimeters)||Standard Error|Mean
151132|NCT00378079|Primary|Heroin Use|opioid urine test results-percent of participants who were opioid-positive|results at one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due-excludes those assessed later or reincarcerated||% participants opioid positive|||Number
151035|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151036|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151037|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151038|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151039|NCT00379769|Secondary|Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60|The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).|Baseline to Month 60 of the randomised dual therapy treatment phase|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||percent change||95% Confidence Interval|Geometric Mean
151040|NCT00379769|Secondary|Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60|Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151041|NCT00379769|Secondary|Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||picamoles/liter (pmol/L)||Standard Error|Mean
151042|NCT00379769|Secondary|Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.|Baseline to Month 60 of the randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||mmol/L (millimoles/Liter)||Standard Error|Mean
151043|NCT00379769|Secondary|Model Adjusted Change From Baseline in HbA1c at Month 60|Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.|Baseline and Month 60 of randomised dual therapy treatment period|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||Percent||Standard Error|Mean
151044|NCT00379769|Secondary|The Number of Participants Starting Insulin at Any Time During the Study|The number of participants starting insulin at any time during the study was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151133|NCT00378079|Primary|Treatment Retention in the Community|days in community treatment|one year post prison release|||Days in community treatment||Standard Deviation|Mean
151046|NCT00379769|Secondary|Number of Participants With Glycaemic Failure Events|Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.|Baseline through to end of randomised dual therapy|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151047|NCT00379769|Secondary|Number of Participants With CV/Microvascular Events|The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151048|NCT00379769|Secondary|Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum|Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||partcipants|||Number
151049|NCT00379769|Secondary|Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths|The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||Number of events|||Number
151050|NCT00379769|Secondary|Number of Participants With Cardiovascular Events and All-cause Deaths|Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151051|NCT00379769|Primary|Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events|The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.|Baseline through End of Study (up to 7.5 years)|Intent-to-Treat (ITT) Population: all randomized participants who were treated with at least one dose of study medication||participants|||Number
151052|NCT00379639|Primary|Best Overall Response|"Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:~Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).|The Efficacy Evaluable (EE) population consisted of all patients who completed at least 2 consecutive cycles of treatment, had at least 1 post-Baseline efficacy assessment performed, and did not have any major protocol violations.||participants|||Number
151053|NCT00379639|Primary|Number of Participants With Adverse Events (AEs)|"AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.~A serious AE is associated with events that pose a threat to a patient’s life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes."|From the date of first dose to 30 days after last dose (up to 236 days).|Safety population.||participants|||Number
151054|NCT00379639|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|"Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:~Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1."|28 days|Safety population - all participants who received at least one dose of study drug.||participants|||Number
151055|NCT00379587|Secondary|Incidence of Adverse Hematological Events|White blood cell decrease, neutrophil cell count decrease, or platelet cell decrease considered possibly or probably related to therapy with rituximab.|by 18 months after peripheral blood stem (PBSC) infusion|||participants|||Number
151056|NCT00379587|Secondary|Incidence of Relapse or Progression of Disease|Percentage of participants with relapsed disease by year 4 post transplant.|by 4 years after peripheral blood stem cell (PBSC) infusion|||percentage of participants|||Number
151057|NCT00379587|Secondary|Incidence of Grade 3 or Higher Infectious Complications||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion|||percentage of participants|||Number
151058|NCT00379587|Primary|Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years||by 1 and 2 years after peripheral blood stem cell (PBSC) infusion|||percentage of participants|||Number
151059|NCT00379574|Secondary|Number of Patients Who Experienced Adverse Events||6 months|||participants|||Number
151060|NCT00379574|Primary|Number of Patients Who Achieved Complete Response|All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.|14 weeks|||participants|||Number
151582|NCT00373360|Secondary|Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8|Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse.|Baseline and Week 8|||participants|||Number
151061|NCT00379353|Secondary|Change in Serum Cytokines and Receptors|Cytokines Levels of IL-1β and its receptor IL RA, IL-6 its receptor IL-6R, and TNF-α and its receptors (i.e. tumor necrosis factor receptor (TNFR)) of TNFR1, TNFR2, IL-10, IL-8(serum) measured at baseline, Days 15 and 29. Multiplex bead Immunoassay used to measure serum/plasma levels of IL-1, IL-6, TNF-α, IL-10, IL-8 and their receptors where assay sensitivity for the cytokines was 3-6 pg/mL. Serum IL-10, IL-1β, IL-1RA, IL-6R, sTNF-RI, sTNF-R2 were also analyzed using an enzyme-linked immunosorbent assay device. Lowering cytokine levels can decrease fatigue, increase appetite and decrease anxiety and depression.|Baseline to Day 15|||pg/mL||Inter-Quartile Range|Median
151062|NCT00379353|Secondary|Change in Body Composition as Measured by Body Mass Index (BMI)|BMI, commonly used to measure overweight and obesity, is a measure of body fat based on a person's weight and height.|Baseline to Day 29|||kg/m^2||Full Range|Median
151063|NCT00379353|Primary|Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS)|ESAS assessment of appetite (symptom) where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. Evaluated at baseline [± 3 days], 2 weeks[± 3 days] and 4 weeks [± 3 days]|Baseline to Day 29|||units on a scale||Full Range|Median
151064|NCT00379353|Secondary|Pittsburgh Sleep Quality Index (PSQI)|PSQI measures the quality and patterns of sleep. It differentiates poor from good sleep by measuring subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A participant indicates how frequently each item was experienced on a scale from 0 to 3. The 7 component scores are then summed to obtain a global sleep score that can range from 0 to 21. A score of >/= 5 indicates poor sleepers.|Baseline to Day 29|||units on a scale||Full Range|Median
151065|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0–3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0–21). The higher the score, the more likely the patient is showing signs of depression and as a result may benefit from a counseling/supportive session.|Baseline to Day 29|||units on a scale||Full Range|Median
151066|NCT00379353|Secondary|Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety)|The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0–3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0–21). The higher the score The higher the score, the more likely the patient is showing signs of anxiety and as a result may benefit from a counseling/supportive session.|Baseline to Day 29|||units on a scale||Full Range|Median
151067|NCT00379353|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|The FACIT-F consists of 27 general quality of life questions divided into 4 domains (physical, social, emotional and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0-4 (0= not at all, 4= very much) where the 13-item fatigue subscore totals are combined for a total of 0 to 52, with the higher number representing greater fatigue.|Baseline to Day 29|||units on a scale||Full Range|Median
151068|NCT00379353|Secondary|Functional Assessment of Anorexia/Cachexia Therapy (FAACT)|12-item symptom-specific subscale of the FACT-G designed to measure participants' additional concerns about their anorexia/cachexia during the previous 7 days. Participant rates concerns from 0 to 4 (0= not at all, 4= very much), combined are the 12 items subscales for a total of 0 to 48 where the higher number would represent greater concern.|Baseline to Day 29|||units on a scale||Full Range|Median
151069|NCT00379288|Primary|The Number of All Randomized Subjects Reporting Adverse Events (AEs).|AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.|1 year|||participants|||Number
151070|NCT00379236|Secondary|Change From Baseline (Extension Study Week 26) in Use of Rescue Medication at Week 52.|The change in the number of tablets of study-specific acetaminophen taken per week as a rescue medication from knee pain.|Extension baseline (week 26 pre-dose), week 52|Intent to treat population||tablets per week||Standard Deviation|Mean
151071|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 52|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer:YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 52 (Extension Study)|Intent to treat population.||participants|||Number
151072|NCT00379236|Secondary|Mean Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Extension Study|The mean difference in participant pain as measured by participants during a walk of 50 feet in length between the baseline (week 26 pre-dose) and week 52 scores. Scores are measured on a visual analog scale of 100 millimeters, with a score of 0 millimeters meaning there was no pain observed; a score of 100 millimeters meaning extreme pain was observed.|Extension baseline (week 26), week 52|Intent to treat population. No imputation for missing values.||units on a scale||Standard Deviation|Mean
151073|NCT00379236|Secondary|Observed Pain Scores on the 50-foot Walk Test During the Extension Study|Participant pain during a walk of 50 feet in length was evaluated by participants on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Baseline (week 26), week 52|Intent to treat population. No imputation for missing values.||units on a scale||Standard Deviation|Mean
151074|NCT00379236|Secondary|Number of Participants With 20 Millimeter or Greater Improvement in Pain Scores on the 50-foot Walk Test|Yes represents the number of participants whose pain during a walk of 50 feet in length was improved at week 26 over baseline by at least 20 millimeters. Pain was evaluated on a 100 millimeter visual analog scale by participants. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0 and 26|Intent to treat population||participants|||Number
156155|NCT00325468|Secondary|Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||Inter-Quartile Range|Median
151075|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. The questionnaire is completed by participants. This table summarizes the change from baseline in participants' physical health.|Weeks 0, 26|Intent to treat population||units on a scale||Standard Deviation|Mean
151076|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) General Health(GH) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' general health scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population||units on a scale||Standard Deviation|Mean
151077|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Bodily Pain(BP) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' bodily pain scores. The questionnaire is completed by participants.|weeks 0 and 26|Intent to treat population||units on a scale||Standard Deviation|Mean
151078|NCT00379236|Secondary|Mean Change From Baseline in Short Form 36 Questionnaire (SF-36) Physical Function (PF) Score at Week 26|The SF-36 questionnaire yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. This table summarizes the change from baseline in participants' physical function. The questionnaire is completed by participants.|Weeks 0, 26|Intent to treat population||units on a scale||Standard Deviation|Mean
151079|NCT00379236|Secondary|Change From Baseline in the Number of Tablets of Rescue Medication Used at Week 26.|The change in the number of tablets of 500 milligram acetaminophen used in a week as rescue medication is compared at weeks 0 and weeks 26.|Weeks 0 and 26|Intent to treat population||tablets per week||Standard Deviation|Mean
151080|NCT00379236|Secondary|Change From Baseline in Patient Global Assessment of Knee Pain at Week 26|Participant assessment of knee pain evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain.|Weeks 0 and 26|Intent to treat population||units on a scale||Standard Deviation|Mean
151081|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Redness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Redness of the knee was subjectively rated as Yes (knee was red) and No (knee was not red).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
151082|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Local Warmth at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Local warmth of the target knee was recorded as Yes (warmth present) or No (knee was not warmer than expected).|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
151083|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Ratings of Knee Tenderness at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Tenderness of the knee was subjectively rated by participants as none, mild, moderate or severe.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
151084|NCT00379236|Primary|Shifts From Extension Study Baseline (Week 26) in Range of Motion Findings at Week 52|Number of participants in various categories of target knee joint examination findings from baseline (week 26 pre-injection) to week 52. Range of motion indicates the flexibility of the knee, and is measured by the number of degrees between when the knee is hyper-extended and when the knee is flexed.|weeks 26 and 52|Safety population which includes all participants who received at least one injection during the extension phase of the study.||participants|||Number
151085|NCT00379236|Primary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the baseline (week 0) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters meaning no pain was observed; a score of 100 millimeters meaning extreme pain was observed.|Weeks 0 and 26|Intent to treat population.||percent change from baseline value||Standard Deviation|Mean
151086|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 26|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|week 26|Intent to treat population||participants|||Number
151087|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Western Ontario McMaster University Osteoarthritis Index (WOMAC A) Pain Scale at Week 12|Responders are identified based on a calculation of three scales: WOMAC (A) pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population||participants|||Number
151134|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|Month 12 to Month 59 post-baseline|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.||Number of participants|||Number
151088|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 26|Intent to treat population||participants|||Number
151089|NCT00379236|Secondary|Number of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the 50-Foot Walk Test at Week 12|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function and global assessment scales. Each of the individual scales was completed by the participant. A participant was a responder (answer: YES) if there was high improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter.|Week 12|Intent to treat population||participants|||Number
151090|NCT00379236|Secondary|Percent Change From Baseline in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study for a Subpopulation of Participants With More Severe Knee Pain|Percent difference in participant pain during a walk of 50 feet in length between the mean screening (week -1) and baseline(week 0) scores, and week 26 scores. Scores are recorded by participants and measured on a visual analog scale of 100 millimeters, with 0 millimeters meaning there was no pain observed; 100 millimeters meaning extreme pain was observed.|weeks -1, 0, and 26|Intent to treat population. A subpopulation of patients with more severe knee pain, as measured by having a greater than or equal to 41 millimeter screening score on the 50-foot walk test.||percentage change from baseline score||Standard Deviation|Mean
151091|NCT00379236|Secondary|Percent Change From Screening in Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The percent difference in participant pain recorded by the participant during a walk of 50 feet in length between the screening (week -1) and week 26 scores. Scores are measured on a visual analog scale of 100 millimeters; a score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|weeks -1 and 26|Intent to treat population||percent change from screening value||Standard Deviation|Mean
151092|NCT00379236|Primary|Observed Pain Scores on 50-foot Walk Test During the Double-blind Study|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were evaluated on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain observed; a score of 100 millimeters means extreme pain was observed.|Weeks 0, 26|Intent to treat (ITT) population.||units on a scale||Standard Deviation|Mean
151093|NCT00379210|Primary|Reaction Times on the Sustained Attention to Response Task.|Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.|9 weeks|||milliseconds||Standard Deviation|Mean
151094|NCT00378703|Secondary|Objective Response Rate|Response was assessed using Solid Tumor Response Criteria (RECIST). Patients with complete responses or partial responses are considered having an objective response.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Proportion of patients||95% Confidence Interval|Number
151095|NCT00378703|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death. Patients alive at last contact were censored on the date of last contact.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Months||90% Confidence Interval|Median
151096|NCT00378703|Secondary|Proportion of Patients With Stable Disease at 6 Months|Patients whose date of progression was after 6 months or who were disease-free at last follow-up beyond 6 months were considered to be stable at 6 months and all other patients were not.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Proportion of patients||95% Confidence Interval|Number
151097|NCT00378703|Primary|Progression-free Survival (PFS)|Progression-free survival is defined as time from randomization to clinical evidence of disease progression or death from any cause without progression. Patients alive without progression were censored at the date of last disease assessment.|Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years|Eligible, treated patients||Months||90% Confidence Interval|Median
151098|NCT00378599|Primary|A Sustained Virologic Response (SVR), Defined as a Plasma HCV RNA Level Below the Lower Level of Quantitation (LLQ) at 24 Weeks Post-treatment|Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.|24 weeks after completion of up to 48 weeks of therapy|Intent to Treat (ITT) Data Set: All enrolled subjects who received at least one dose of any study medication (PEG-Intron or Rebetol (RBV)). Analysis of all primary and secondary efficacy endpoints and safety variables was based on the ITT population.||Participants|||Number
151099|NCT00378573|Secondary|Overall Survival|Survival is defined as the time from the date of registration to the study to the date of death.|2 years post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.||Month|||Number
151114|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]~For presentation, the C-peptide data were converted to the AUC as pmol/ml. This is adjusted for baseline."|At month 12 post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||pmol/ml||95% Confidence Interval|Least Squares Mean
156156|NCT00325468|Primary|Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||95% Confidence Interval|Least Squares Mean
151100|NCT00378573|Secondary|Objective Response Rate (Complete Response [CR] Plus Partial Response [PR]) Using Response Evaluation Criteria in Solid Tumors (RECIST)|"Complete response is defined as disappearance of all target and nontarget lesions identified and reported at baseline (at or within 4 weeks before the beginning of treatment) by image-based evaluations such as computerized tomography (CT) or magnetic resonance imaging (MRI).~Partial response is defined as persistence of one or more nontarget lesions and at least 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters."|1 year from start of treatment|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.||Participants|||Number
151101|NCT00378573|Primary|Progression Free Survival for Subjects With Locally Advanced or Metastatic (Stage IIIB or Stage IV) Non-Small Cell Lung Cancer (NSCLC) After Systemic Treatment With Gemcitabine, Docetaxel, and Bevacizumab as First Line Therapy||1 year post-registration|Due to early termination of the study only 17/90 subjects enrolled. Efficacy analysis of Progression Free Survival and Overall Survival were not performed. Efficacy results limited to a descriptive summary of best overall response for each subject.||Days||95% Confidence Interval|Median
151102|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
151103|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
151104|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)|"Month 7 HPV cLIA Geometric Mean Titers by vaccine group.~The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
151105|NCT00378560|Secondary|Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)|"Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.~The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0."|At one month after completed vaccination series (Month 7)|Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
151106|NCT00378560|Primary|Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype|Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.|Over 30 months|Includes participants who were not general protocol violators, received all 3 vaccinations, and were seronegative at Day 1 and PCR negative through Month 7 for the relevant HPV type||Incidence per 100 person-years|||Number
151107|NCT00378534|Secondary|Standard Transplant Outcome Variables Such as Non-hematologic Toxicity, Incidence and Severity of Acute and Chronic GVHD and Relapse of Disease.||3 years maximum||||||
151108|NCT00378534|Primary|Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200.|Day 200|||participants|||Number
151109|NCT00378508|Secondary|Baseline Hemoglobin A1c||At baseline (before treatment)|||percentage of hemoglobin A1c||95% Confidence Interval|Least Squares Mean
151110|NCT00378508|Secondary|Baseline Insulin Use||At baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||U/kg/d||95% Confidence Interval|Least Squares Mean
151111|NCT00378508|Primary|C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline|"C-peptide secretory response was calculated as ln[(Area Under the Curve of the C-peptide from the 240 minute MMTT/240 +1]~For presentation, the C-peptide data were converted to the AUC as pmol/ml. This baseline data was used to adjust for the C-peptide AUC primary endpoint measure at 12 months."|At Baseline (before treatment)|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||pmol/ml||95% Confidence Interval|Least Squares Mean
151112|NCT00378508|Secondary|Average Insulin Use Over 12 Months||After 12 months post-treatment|This endpoint was compared in the modified intent to treat population which included all subjects with at least one post-randomization mixed meal tolerance test (MMTT)||U/kg/d||95% Confidence Interval|Least Squares Mean
151113|NCT00378508|Secondary|Hemoglobin A1c||At 12 months post-treatment|||percentage of hemogloblin A1c||95% Confidence Interval|Least Squares Mean
151116|NCT00378378|Primary|Change From Baseline 24-hour Urinary Free Cortisol Level|The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject’s 24-hour urinary free cortisol level.|Baseline to Endpoint|Not all participants that were randomized had both a baseline and an endpoint urine sample. Only participants with both were included in the participants analyzed.||mcg/hour||Standard Deviation|Least Squares Mean
151117|NCT00378326|Primary|Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus|Survival in patients with paraneoplastic disease who are treated with Tacrolimus, from time of tacrolimus treatment|through study completion, median 3 years of follow up|||months||95% Confidence Interval|Median
151118|NCT00378326|Secondary|Cerebrospinal Fluid (CSF) Pleocytosis||White blood cell count in CSF was measured at two time points, pre- and post-treatment|"19 treatment events in 16 patients at which both pre- and post-treatment CSF samples available.~The data are reported below, separately for pre-treatment samples and post-treatment samples."||cells/mm^3|Participants|Full Range|Median
151119|NCT00378209|Secondary|Overall Survival|defined as time from treatment initiation to death, or last known to be alive for those who had not died|assesed at a median follow-up of 44 months|||month||95% Confidence Interval|Median
151120|NCT00378209|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died.|aassesed at a median follow-up of 44 months|||months||95% Confidence Interval|Median
151121|NCT00378209|Secondary|Duration of Response|Duration of response will be measured as the time from initiation of a response to first documentation of disease progression or death, or date last known progression-free and alive for those who have not progressed or died.|Assessed at a median follow-up of 44 months|||months||95% Confidence Interval|Median
151122|NCT00378209|Secondary|Objective Response Rate|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).~Objective response was defined by the achievement of at least Partial Response (PR) or better (CR-complete response, nCR-near complete response, and VGPR-very good partial response)."|Assessed every cycle for up to 8 cycles and best response was reported|||percentage of treated patients||90% Confidence Interval|Number
151123|NCT00378209|Primary|The Proportion of Patients Alive and Without Progressive Disease (PD) for ≥6 Months|"Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG).~Progressive disease (PD) required one or more of the following:~>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation) >25% increased in plasma cells in a bone marrow aspirate or on trephine biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.~Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).~Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|6 months after therapy|||percentage of treated patients||90% Confidence Interval|Number
151124|NCT00378105|Secondary|Estimated 18-month Overall Survival Rate|Overall survival was measured from treatment initiation to death, censored at the date patients were last known to be alive for those who had not died.|Survival rate at 18 months|||Percentage of participants||95% Confidence Interval|Number
151125|NCT00378105|Secondary|Percentage of Patients Who Remained in Response for More Than 18 Months|Duration of response was measured from first response to progression or death, censored at the date patients were last known to be alive and disease free for patients who had not progressed or died.|Response rate at 18 months|||Percentage of participants||95% Confidence Interval|Number
151126|NCT00378105|Secondary|Estimated 18-month Progression Free Survival (PFS) Rate|"PD from European Bone Marrow Transplant (EBMT) Response Criteria Required one or more:~>25% increased in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, or >25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24 h and confirmed on a repeat investigation), or >25% increased in plasma cells in a bone marrow aspirate or biopsy (must also be an absolute increase of at least 10%) Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas.~Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture).~Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).~PFS was measured from treatment initiation to progression or death, censored at the date patients were last known to be alive and disease free"|PFS rate at 18 months|This numbers excluded 2 patients who went off study prior to start of therapy.||Percentage of participants||95% Confidence Interval|Number
151127|NCT00378105|Primary|Objective Response Rate of the Drug Combination in This Patient Populations.|Overall Response (OR) was defined as partial response (PR) or better. Response was assessed according to European Group for Blood and Marrow Transplant criteria, modified to include nCR and VGPR, from the International Uniform Response Criteria.|Full response assessment was conducted at the end of cycle 8 (average of168 days) and after cycle 4 (84 days) for patients proceeding to transplant.|The numbers excluded 2 patients who went off study prior to start of therapy||percentage of participants||90% Confidence Interval|Number
151128|NCT00378079|Secondary|Employment|number of days employed, past 30 days-self report, assessed one year post-prison release|one year|||number of days employed, past 30||Standard Deviation|Mean
151129|NCT00378079|Primary|Criminal Activity|self reported days of criminal activity|one year post prison release|||number of days||Standard Deviation|Mean
151130|NCT00378079|Primary|HIV-risk Behaviors||one year||||||
151131|NCT00378079|Primary|Cocaine Use|cocaine urine test results-percent of participants testing positive for cocaine|one year post prison release|Includes participants who provided urine samples at the time their 1-year post-prison release assessment was due, excludes those assessed later or reincarcerated||percent cocaine positive participants|||Number
153641|NCT00356148|Primary|Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group).||1 month|Analysis was intent-to-treat||participants|||Number
151135|NCT00378014|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|From randomization to Month 11|Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.||Number of participants|||Number
151136|NCT00378014|Secondary|Hepatitis C Virus (HCV) Replication in HCV-positive Patients|HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).|Baseline, Month 5|ITT||Percentage of participants|||Number
151137|NCT00378014|Secondary|Patient and Graft Survival|Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.|Month 11|ITT||Percentage of Participants|||Number
151138|NCT00378014|Secondary|Incidence of Treated BPAR|The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).|Month 11|ITT||Percentage of Participants|||Number
151139|NCT00378014|Secondary|Renal Function (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 5|ITT||mL/min||Standard Deviation|Mean
151140|NCT00378014|Secondary|Incidence of Renal Deterioration|Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.|Baseline, Month 11||||||
151141|NCT00378014|Secondary|Incidence of the Need for a Change in the Immunosuppressive Regimen|The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).|Month 11|ITT||Percentage of participants|||Number
151142|NCT00378014|Secondary|Incidence of Efficacy Failure|Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).|Month 11|ITT||Percentage of participants|||Number
151143|NCT00378014|Primary|Calculated Glomerular Filtration Rate (cGFR)|This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.|Month 11|ITT||mL/min||Standard Deviation|Mean
151144|NCT00377962|Secondary|Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Participants|||Number
151145|NCT00377962|Secondary|Mean Days of Hospitalization From Baseline to End of Study (Month 24)||Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Days||Standard Deviation|Mean
151146|NCT00377962|Secondary|Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||%||Standard Deviation|Mean
151147|NCT00377962|Secondary|Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup|Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function.|Baseline to end of study (Month 24)|Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||cm||Standard Deviation|Mean
151148|NCT00377962|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Liters||Standard Deviation|Mean
151149|NCT00377962|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup|Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function.|Baseline to end of study (Month 24)|Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Liters||Standard Deviation|Mean
151150|NCT00377962|Secondary|Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)||Month 12 to end of study (Month 24)|The intent-to-treat (ITT) population consisted of all patients as randomized, who were given at least one dose of study drug and had at least one post-baseline assessment. (Extension study)||Participants|||Number
151151|NCT00377962|Secondary|Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)|Number of patients not alive and number of patients with loss of their graft.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Participants|||Number
151152|NCT00377962|Secondary|Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)|Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart & Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy.|Month 12 to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||Participants|||Number
151153|NCT00377962|Secondary|Change in Serum Creatinine From Baseline to End of Study (Month 24)|Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||μmol/L||Standard Deviation|Mean
151154|NCT00377962|Secondary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||mL/min||Standard Deviation|Mean
151155|NCT00377962|Primary|Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12|Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.|Baseline to Month 12|Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.||mL/min||Standard Deviation|Mean
151156|NCT00377858|Secondary|Change From Baseline in Absolute Body Weight at 36 Week Endpoint|Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.|Baseline, 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||kilograms||Standard Error|Least Squares Mean
151157|NCT00377858|Secondary|Number of Insulin Injections Per Day||Weeks 12, 24, 30, 36|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||insulin injections||Standard Error|Least Squares Mean
151158|NCT00377858|Secondary|Endpoint Insulin Dose; Total, Basal, and Prandial|Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||U/day||Standard Error|Least Squares Mean
151159|NCT00377858|Secondary|Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial|Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.|36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||U/kg/day||Standard Error|Least Squares Mean
151160|NCT00377858|Secondary|Number of Patients With at Least One Severe Hypoglycemia Episode|Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.||participants|||Number
151161|NCT00377858|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.||hypoglycemic event per 30 days||Standard Deviation|Mean
151180|NCT00377741|Secondary|Apparent Elimination Rate (Kelim) of Ganciclovir|The apparent elimination rate is equal to the magnitude of the slope from the log-linear regression of plasma concentration versus time over the interval t to 24, where t is the first time-point used for this regression. Kelim was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||1/h||Standard Deviation|Mean
151394|NCT00375492|Secondary|Change From Baseline in Total Cholesterol at Week 24|Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0). Total cholesterol measured in mmol/L.|baseline, week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
151162|NCT00377858|Secondary|Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia|Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.|Baseline to 36 Weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.||participants|||Number
151163|NCT00377858|Secondary|Glycemic Variability|Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
151164|NCT00377858|Secondary|7-point Self-monitored Blood Glucose Profiles|Actual daily mean blood glucose levels at specified time points.|Baseline, 12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
151165|NCT00377858|Secondary|Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint||12-24-36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).||percentage of participants|||Number
151166|NCT00377858|Secondary|Hemoglobin A1c (HbA1c) at Interval Visits|Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.|12, 24, and 36 weeks|Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.||percent HbA1c||Standard Error|Least Squares Mean
151167|NCT00377858|Primary|Hemoglobin A1c (HbA1c) at 36 Week Endpoint|Level of hemoglobin A1c at endpoint.|36 weeks|Number of participants in the per-protocol population. Last observation carried forward.||percent HbA1c||Standard Error|Least Squares Mean
151168|NCT00377832|Secondary|Rate of Neonatal Sepsis|the number of participants who developed neonatal sepsis|7 days|||participants|||Number
151169|NCT00377832|Secondary|Rate of Diagnosis of Clinical Chorioamnionitis|Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.|Labor--up to 24 hours|||participants|||Number
151170|NCT00377832|Secondary|Rate of Subsequent Development of Maternal Fever|Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.|Labor--up to 24 hours|||participants|||Number
151171|NCT00377832|Secondary|Rate of Determination of Non-reassuring Fetal Status|Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.|Labor--up to 24 hours|||participants|||Number
151172|NCT00377832|Secondary|Rate of Cesarean Delivery|Rate of cesarean delivery|Labor--up to 24 hours|||participants|||Number
151173|NCT00377832|Secondary|Temperature Difference Before and After Treatment|Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade|90 minutes|||degrees Centigrade||Inter-Quartile Range|Median
151174|NCT00377832|Primary|Baseline Fetal Heart Rate (FHR) After Treatment||90 minutes|||beats per minute||Standard Deviation|Mean
151175|NCT00377832|Primary|Maternal Body Temperature 90 Minutes After Randomization|Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.|90 minutes|||degrees centigrade||Inter-Quartile Range|Median
151176|NCT00377819|Secondary|Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)|Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.|Baseline, 3 months|Participants with non-missing baseline evaluation and non-missing post-baseline evaluation at month 3.||Percent Change||Inter-Quartile Range|Median
151177|NCT00377819|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.||Percent Change||95% Confidence Interval|Least Squares Mean
151178|NCT00377819|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.|Baseline, 12 months|Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.||Percent Change||95% Confidence Interval|Least Squares Mean
151179|NCT00377741|Secondary|Plasma Half-Life (T1/2) of Ganciclovir|Plasma half-life is the time measured for the plasma concentration to decrease by one half. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1. T1/2 was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||h||Standard Deviation|Mean
153653|NCT00356057|Secondary|Rate of CHF Hospitalizations and Total Mortality||at six months post-procedure||||||
153654|NCT00356057|Secondary|Changes in NYHA Classification||at six months post-procedure||||||
151181|NCT00377741|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir|The Tmax is defined as time to reach maximum observed Ganciclovir concentration. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||h||Full Range|Median
151182|NCT00377741|Primary|Maximum Observed Plasma Concentration (Cmax) of Ganciclovir|The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||μg/mL||Standard Deviation|Mean
151183|NCT00377741|Primary|Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)|The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC [0-tau]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post–dose|The Pharmacokinetic (PK) analysis population included all participants who received study medication and had at least one PK sample.||h*mcg/mL||Standard Deviation|Mean
151184|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 for Subjects With a Baseline HbA1c of ≥ 7.5% Who Were Taking at Least One Oral Hypoglycemia Agent (OHA) at Baseline.|The difference between Cycloset and placebo in the change in HbA1c from baseline to Week 24 was analyzed for subjects with a baseline HbA1c of ≥ 7.5% who were taking at least one oral hypoglycemia agent (OHA) at baseline. The primary analysis was based on subjects from the evaluable per protocol efficacy (EPPE) analysis set with a secondary analysis using subjects from the intent to treat efficacy (ITTE) analysis set for subjects completing 24 weeks of treatment. Change is reported as the absolute difference in % HbA1c.|Baseline to week 24|randomized subjects with a baseline HbA1c of >= 7.5 taking one or two oral diabetes agents (not insulin)||percent||Standard Deviation|Least Squares Mean
151185|NCT00377676|Secondary|Change in HbA1c From Baseline to Week 24 in Subjects Failing Treatment With Metformin Plus a Sulfonylurea|"Change in HbA1c from baseline to week 24 in subjects failing treatment with metformin plus a sulfonylurea with failure defined as having a baseline HbA1c value of ≥ 7.5%. Change was measured at week 24 after randomization in subjects having no major protocol violations.~Change is reported as the absolute difference in % HbA1c."|Baseline to week 24|subjects with baseline HbA1c of >= 7.5 and taking both metformin/sulfonylurea but not insulin. Analysis was conducted for those completing 24 weeks of treatment and on the ITT using the LOCF for those not completing 24 weeks of treatment.||percent||Standard Deviation|Least Squares Mean
151186|NCT00377676|Secondary|Number of Subjects Experiencing Serious Cardiovascular Adverse Events|The secondary safety endpoint is number subjects with occurrences of first cardiovascular SAE (myocardial infarction, stroke, in-patient hospitalization for heart failure, angina or revascularization surgery).|Baseline to week 52.|intent to treat||Subjects|||Number
151187|NCT00377676|Primary|Subjects Experiencing Serious Adverse Events|Number of subjects reporting all-cause Serious Adverse Events (SAEs) for usual drug therapy plus Cycloset vs. that for usual drug therapy (UDT) plus placebo from baseline to week 52.|From baseline to week 52.|||participants|||Number
151188|NCT00377637|Secondary|Maintenance Phase: Participants With Major Extra-renal Flare|A major extra-renal flare is defined as a British Isles Lupus Assessment Group (BILAG) Score category A in one extrarenal organ or three organs with concurrent category B scores. BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.||participants|||Number
151189|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy|The primary efficacy parameter was the time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), defined as any of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to rescue treatment for each patient. The data presented are the percentage of participants who were rescue treatment free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||Percentage of participants|||Number
151190|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval|A proteinuric flare is defined as a doubling of the urine protein:creatinine ratio, and proteinuria ≥1 g/24 h in patients with urine protein ≤0.5 g/24 h at the end of the induction phase, or proteinuria ≥2 g/24 h if urine protein was >0.5 g/24 h at the end of the induction phase. A nephritic flare is defined as a 25% increase in serum creatinine accompanied by 1 or more of the following: (a) simultaneous doubling of the proteinuria reaching a minimum of 2 g/24 h (b) new/increased hematuria or (c) the appearance of cellular casts. All flares were adjudicated by a clinical endpoints committee.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||Percentage of participants|||Number
151278|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the end-of-therapy visit.||participants|||Number
151191|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine|Sustained doubling of serum creatinine concentration is defined as the first serum creatinine value that is twice the mean of the lowest 2 values from screening to end of induction, as confirmed by a second serum creatinine value obtained at least 4 weeks after the initial doubling.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||participants|||Number
151192|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)|Time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), was defined as any 1 the following: death, ESRD, sustained doubling of serum creatinine, renal flare (proteinuric or nephritic), or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. ESRD is defined as progression to chronic hemodialysis or renal transplant.|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population. The analysis includes all event data, regardless of whether or not the event was the earliest Clinical Endpoints Committee-adjudicated reason for treatment failure.||participants|||Number
151193|NCT00377637|Secondary|Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths|Treatment Failure was adjudicated by a clinical endpoints committee (CEC) and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis (LN).|From the start of the Maintenance Phase to Month 36|Maintenance Phase intent to treat population.||Deaths|||Number
151194|NCT00377637|Secondary|Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores|The SF-36 is a 36 item quality of life questionnaire. The short-form version has eleven questions that permit the participant to rate how they feel that particular day. The SF-36 consists of eight scaled scores and two component scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score with the higher scores indicating better quality of life.|Baseline and 24 weeks|"This analysis population is intention to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||Scores on a scale||Standard Deviation|Mean
151195|NCT00377637|Secondary|Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score|"BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. The BILAG individual system summaries were calculated by a program supplied by ADS-Limathon (Sheffield, UK).~The score at baseline was compared to the score at the 24 week endpoint for each treatment group, reported here for the renal system."|Baseline, 24 weeks|Analysis population was intent to treat. The endpoint was defined using the last observation carried forward approach. If no post-Baseline value was available, endpoint was considered missing.||Percentage of participants|||Number
151196|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Albumin||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||g/L||Standard Deviation|Mean
151197|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein|24-hour urine protein was measured at Baseline and Week 24.|Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||mg/day||Standard Deviation|Mean
151198|NCT00377637|Secondary|Induction Phase: Change From Baseline to Week 24 in Serum Creatinine||Baseline, Week 24|"Analysis population was intent to treat. The analysis included only those patients for whom data was available at both time points, as indicated by n."||µmol/L||Standard Deviation|Mean
151199|NCT00377637|Secondary|Induction Phase: Number of Participants Achieving Complete Remission|Number of participants achieving complete remission as defined by return to normal serum creatinine, proteinuria ≤500 mg/24 hours and an inactive urinary sediment (absence of red blood cells, white blood cells or cellular or granular casts) after 24 weeks.|24 weeks|Analysis population was intent to treat.||participants|||Number
151200|NCT00377637|Primary|Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval|Treatment Failure was adjudicated by a clinical endpoints committee and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to treatment failure for each patient. The data presented are the percentage of participants who were treatment-failure free at each time interval as estimated by Kaplan-Meier.|From the start of the Maintenance Phase to Month 36|Intent to treat analysis population which consisted of all subjects who were randomized to the maintenance phase of the study and had at least 1 maintenance efficacy assessment.||Percentage of participants|||Number
151201|NCT00377637|Primary|Induction Phase: Number of Patients Showing Treatment Response|Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to <3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria <3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week 24 or who withdrew earlier than Week 24 were considered non-responders.|24 weeks|Analysis population was intent to treat which comprised all subjects who were randomized into the study and had at least one post-baseline efficacy assessment.||participants|||Number
151287|NCT00377234|Secondary|Intensity of Upper Gastrointestinal (GI) Symptoms|Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.|within 3 months|Safety analysis set||percentage of participants|||Number
153655|NCT00356057|Secondary|Cardiac Remodeling Assessments by Echocardiography||at six months post-procedure||||||
153656|NCT00356057|Secondary|Improvement in QOL Score||at six months post-procedure||||||
151202|NCT00377572|Secondary|Paediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall Score|"Asthma-specific quality of life (QOL) validated tool designed for children 7 to 17 years of age. PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). Actual scores ranged from 2.1 to 7.~PAQLQ scores were available for 338 of 419 (81%) of study participants, 170 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm."|Week 60|Intent-to-treat||units on a scale||Standard Deviation|Mean
151203|NCT00377572|Secondary|Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall Score|"Asthma-Specific Quality of Life (QOL) Measure . The PACQLQ is a validated tool that measures limitations and anxieties faced by primary caregivers of children with asthma. Scores are calculated as the mean score within two domains of questions (re: activity limitation and emotional function) and overall scores represent the mean across all questions. The use of the PACQLQ is valid for use in the caretakers of children ages 7 to 17 years of age. Higher scores indicate better quality of life. Minimum possible score is 1 (maximum impairment); maximum possible score is 7 (no impairment). The range of actual scores were a minimum of 2.4 and a maximum of 7.~Method: Caretaker self-report. PACQLQ scores were available for 320 of 419 (76%) of study participant caretakers (159 in the Omalizumab (Xolair) + Conventional Therapy arm)."|Week 60|Intent-to-treat||units on a scale||Standard Deviation|Mean
151204|NCT00377572|Secondary|Percent Prevalence: Asthma Exacerbations|Percent participants with >=1 exacerbations. An exacerbation was defined as a prednisone burst (a minimum of 20 mg per day of prednisone, or the equivalent, taken for any 3 of 5 consecutive days) or hospitalization. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||percent prevalence|||Number
151205|NCT00377572|Secondary|Percent Prevalence: Asthma-Related Medical Care Resource Utilization - Hospitalizations|Percent participants with >=1 hospitalizations. A hospitalization is defined as an asthma-related, overnight hospitalization. . Results values are model predicted numbers,(e.g., odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||percent prevalence|||Number
151206|NCT00377572|Secondary|Percent Prevalence: Prescribed Rescue Beta 2 Agonists|Percent of participants prescribed long-acting beta 2 agonists to maintain asthma control. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant. Results values are model predicted numbers, (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||percent prevalence|||Number
151207|NCT00377572|Secondary|Dose Inhaled Corticosteroids (Glucocorticoids)|Prescribed dose (mcg/day) of inhaled glucocorticoids to maintain asthma control. The dose of inhaled glucocorticoids was converted to the budesonide-equivalent dose. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||mcg/day||Standard Error|Least Squares Mean
151208|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 4 Through 6 (Severe Asthma)|Steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone–salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at least one value was available in this period and at baseline for a participant. Results values are model predicted numbers,(e.g, odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat||percent prevalence|||Number
151209|NCT00377572|Secondary|Percent Prevalence: Treatment Step Level 1 or 2 (Mild Asthma)|Treatment steps were established, per the National Asthma Education and Prevention Program Expert Panel Report 3 guidelines. Steps 1-2 apply to mild asthma, 3 to moderate asthma, and 4-6 to severe asthma. At Step 0, the recommendation is for no asthma-control medication or albuterol as needed; at 1, budesonide 180 mcg once a day; at 2, budesonide 180 mcg twice a day; at 3, budesonide 360 mcg twice a day; at 4, fluticasone–salmeterol (Advair, GlaxoSmithKline) 250 mcg fluticasone and 50 mcg salmeterol twice a day; at 5, Advair 250 mcg and 50 mcg twice a day plus montelukast once a day; and at 6, Advair 500 mcg and 50 mcg twice a day plus montelukast once a day. (The doses for montelukast are 5 mg per day for those <=14 years old and 10 mg per day for those >=15 years.) Data represent an average of those in the time period, where at >/= 1 value was available in this period and at baseline for a participant; results are model predicted numbers (e.g.,odds ratios converted to percentages).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat||percent prevalence|||Number
151210|NCT00377572|Secondary|Percent Adherence to Asthma Medication|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration every 3 months. Adherence data as an outcome were available in 384 of the 419 participants, 193 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment|Intent-to-treat||percentage of expected dose taken||Standard Error|Least Squares Mean
151305|NCT00376935|Secondary|Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to week 24|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||participants|||Number
151211|NCT00377572|Secondary|Exhaled Nitric Oxide|Exhaled nitric oxide is a biomarker of airway inflammation. Measurement (in parts per billion,ppb) of exhaled nitric oxide (eNO) prior to spirometry, employing a technique modified after Silkoff et al (1997) and following American Thoracic Society guidelines for eNO assessment (American Thoracic Society, 1999). Nitric oxide concentrations were measured using a rapid-response chemiluminescent analyzer (NIOX™ System, Aerocrine, Sweden) which has a response time of < 700 ms for 10-90% full scale. The Food and Drug Administration has approved this device for clinical application in asthma management. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||ppb||Standard Error|Least Squares Mean
151212|NCT00377572|Secondary|FEV1/FVC Ratio|"The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.~FEV1/FVC ratio data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant."|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Ratio (x100)||Standard Error|Least Squares Mean
151213|NCT00377572|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|FEV1 is air volume exhaled in 1 second during spirometry. For the trial, mild asthma is defined as pre-bronchodilator FEV1 ≥80% predicted, requiring no/low-moderate dose of inhaled glucocorticoids; moderate asthma and severe asthma, respectively, as pre-bronchodilator FEV1 <80% predicted requiring the same glucocorticoids as mild asthma and FEV1 <80% predicted requiring high-dose inhaled glucocorticoids (with/without continuous oral glucocorticoids) or uncontrolled despite treatment. FEV1 % of predicted is FEV1 converted to a percentage of normal, based on height, weight, and race. FEV1 percent predicted data as an outcome measure were available in 363 of the 419 participants, 190 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Percent||Standard Error|Least Squares Mean
151214|NCT00377572|Secondary|Asthma Control Test (ACT) Score|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients >= 12 years of age. It is a questionnaire comprised of 5 questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores were added together to calculate a total score. Total scores can range from 5 to 25. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference for ACT is 3 points. ACT scores as an outcome measure were available in 150 of the 419 participants, 77 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||ACT score||Standard Error|Least Squares Mean
151215|NCT00377572|Secondary|Child Asthma Control Test (C-ACT) Score|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined. C-ACT scores were available as an outcome measure in 236 of the 419 participants, 118 of whom were in the Omalizumab (Xolair) + Conventional Therapy arm. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of treatment.|Intent-to-treat||C-ACT score||Standard Error|Least Squares Mean
151216|NCT00377572|Secondary|Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma|The number of work days missed by the caretaker due to the study participant’s asthma was available for 138 of 419 (33%) study participant caretakers. Source of data: caretaker self-report. Data represent an average of those collected in the time period (weeks 12-60).|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Days||Standard Error|Least Squares Mean
151217|NCT00377572|Secondary|Economic Outcome: Comparison of Number of Missed School Days Due to Asthma|The number of school days missed was available for 307 of the 419 (73%) study participants, of which 152 were in the Omalizumab (Xolair) + Conventional Therapy arm. Source of data: caretaker/participant self-report. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Days||Standard Error|Least Squares Mean
151218|NCT00377572|Primary|Maximum Number of Asthma Symptom Days|Maximum symptom days was calculated as the largest of the following variables: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per a 2-week look-back period. A higher score reflected a greater number of asthma symptoms. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.|Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.|Intent-to-treat||Days||Standard Error|Least Squares Mean
151219|NCT00377520|Secondary|Number of Participants With Adverse Events by Grade (Measures of Toxicity)|Adverse events were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). The worst grade event per cycle is reported.|every 21-day cycle (up to 24 months)|||participants|||Number
151306|NCT00376935|Secondary|Qualitative Hepatitis C Virus RNA||At study entry|||participants|||Number
153657|NCT00356057|Secondary|Improvement in 6-minute Walk Test||at six months post-procedure||||||
151220|NCT00377520|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions; Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 24 months)|||participants|||Number
151221|NCT00377455|Secondary|Quality of Life (QOL)|QOL is measured using the Short Form 36 Health Survey (SF-36, which measures health on eight dimensions: general health perception, physical and social functioning, role limitations by physical or emotional problems, mental health, vitality, and bodily pain. For each dimension items are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).|16 weeks||||||
151222|NCT00377455|Secondary|Endothelin-1(ET-1) Level|From saved serum|16 weeks||||||
151223|NCT00377455|Secondary|Brain Natriuretic Peptide (BNP) Level|Serum BNP level|16 weeks||||||
151224|NCT00377455|Secondary|6-minute Walk Distance|The distance walked during a 6-minute walk test.|16 weeks||||||
151225|NCT00377455|Primary|Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol.||This will be determined after 16 weeks on the study medication.||||||
151226|NCT00377429|Secondary|Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||3 months|Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.||participants|||Number
151227|NCT00377429|Secondary|Number of Participants Who Survived (Post-study at 24 Month Visit)|Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die|2 years|Post study full analysis set||participants|||Number
151228|NCT00377429|Secondary|Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)||2 years|Post study full analysis set||weeks||Full Range|Median
151229|NCT00377429|Secondary|Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)||Baseline|2nd look laparoscopy/laparotomy||Participants|||Number
151230|NCT00377429|Secondary|Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy|Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.|2 months|Full analysis population||Participants|||Number
151231|NCT00377429|Primary|Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days||21 days|Treated population||Participants|||Number
151232|NCT00377403|Primary|SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3|The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact).|4 days|We analysed all participants for whom we had data at Day 3. We were unable to complete the telephone interview with 11 subjects.||Units on a scale||Standard Deviation|Mean
151233|NCT00377364|Secondary|Asthma Control Questionnaire|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
151234|NCT00377364|Secondary|Asthma Control Questionnaire (ACQ)|This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).|Baseline|||units on a scale||Standard Deviation|Mean
151235|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
151236|NCT00377364|Primary|Young Mania Rating Scale (YMRS)|This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).|Baseline|||units on a scale||Standard Deviation|Mean
151237|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
151318|NCT00376675|Secondary|AUC of Vitality as Measured by the Short Form-36 Vitality Subscale at Baseline and at Weeks 1-4|The SF-36 is a 36-item short form to measure health status in various populations. The vitality subscale is comprised of 4 items and is a measure of energy level as well as fatigue. The AUC for the vitality subscale at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline Vitality subscale score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
151238|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||units on a scale||Standard Deviation|Mean
151239|NCT00377364|Secondary|Internal State Scale - Activation (ISS-ACT)|Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.|Baseline|||units on a scale||Standard Deviation|Mean
151240|NCT00377364|Primary|Hamilton Rating Scale for Depression (HRSD-17)|The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).|Baseline|||units on a scale||Standard Deviation|Mean
151241|NCT00377364|Primary|Rey Auditory Verbal Learning Task (RAVLT)|This is a measure of declarative memory (associated with the hippocampus), using the mean number of words (0-75) recalled from Trials I-V of the RAVLT ± the standard deviation. The assessement was conducted using the same procedures as at baseline. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Exit (Day 3 or Day 7)|ITT defined as any post baseline visit. Last Observation Carried Forward.||words||Standard Deviation|Mean
151242|NCT00377364|Primary|Rey Auditory Verbal Learning Test (RAVLT)|This is a measure of declarative memory (associated with the hippocampus). The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.|Baseline|||words||Standard Deviation|Mean
151243|NCT00377312|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
151244|NCT00377312|Secondary|Amino-terminal Peptides of Procollagen- 1(P1NP)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
151245|NCT00377312|Secondary|Serum Carboxy-terminal of Collagen- 1(sCTX)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
151246|NCT00377312|Secondary|Serum Amino-terminal of Collagen- (sNTX)|% change from baseline|baseline, daily, one week follow-up|||% change from baseline||Standard Error|Mean
151247|NCT00377312|Secondary|Tubular Maximum for Phosphorous|mg/dl|baseline and daily|||mg/dl||Standard Error|Mean
151248|NCT00377312|Secondary|24 Hour Urine Calcium|mg/gm creatinine|24 hours period from Day 7 to Day 8|||mg/gm creatinine||Standard Error|Mean
151249|NCT00377312|Secondary|Fractional Excretion of Calcium|% = (S Creatinine X U Calcium)/(S Calcium X U Creatinine)|baseline and daily|||% of excretion||Standard Error|Mean
151250|NCT00377312|Secondary|Parathyroid Hormone (1-84)|pg/ml|baseline, daily up to Day 8 and follow-up|||pg/ml||Standard Error|Mean
151251|NCT00377312|Secondary|1,25 Vitamin D|pg/ml|baseline, daily up to Day 8 and follow-up|||pg/ml||Standard Error|Mean
151252|NCT00377312|Primary|Serum Phosphorous|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
151253|NCT00377312|Primary|Ionized Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
151254|NCT00377312|Primary|Total Serum Calcium|mg/dl|12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete|||mg/dl||Standard Error|Mean
151255|NCT00377312|Primary|Participants With Dose Limiting Toxicity|DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall >30 mm/hg), tachycardia (pulse > 120), hypertension (systolic BP >160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous < 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.|12 hours after the infusion was started then q 8 hours for 7 days|||participants|||Number
151256|NCT00377299|Secondary|Stroop Color Word Test|The Stroop Color Word Test measures the individual's ability to separate the word and color naming stimuli thus the ability to sort information from the environment and selectively react to this information. The scoring is a measure of time to complete 100 items and the numbers of items that can be completed. THe scores are converted into T-scores which have a mean of 50 and a standard deviation of 10.|12 weeks|||T score||Standard Error|Mean
153658|NCT00356057|Primary|System-related Complication-free Rate||at six months post-procedure||||||
151257|NCT00377299|Secondary|Hopkins Auditory Verbal Learning Test (HVLT)|The Hopkins Auditory Verbal Learning Test (HVLT) is a measure of cognition (memory/recall). Raw scores are derived for Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index. Raw scores are calculated into T-scores. T-scores are standardized scores on each dimension for each type. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.||T score||Standard Error|Mean
151258|NCT00377299|Secondary|Amphetamine Use|Participant reported days per 7-day week of methamphetamine use.|12 weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.||days per week||Standard Error|Mean
151259|NCT00377299|Secondary|Amphetamine Craving|Visual Analog Scale (VAS) assessing Methamphetamine craving with a 1-100 scale.Higher values on the VAS scale indicate a higher Methamphetamine craving(worse outcome).|12 Weeks|ITT includes those returning for at least one post baseline visit. LOCF used for end point data.||scores on a scale||Standard Error|Mean
151260|NCT00377299|Primary|Depression Symptoms|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C), (a clinician-administered depression scale) is used to assess the severity of depressive symptoms.Scores can range from 0 to 84. The higher the score, the worse the depressive symptoms(worse outcome).|12 weeks|The intent to treat (ITT) group includes all who returned for at least one post baseline visit. Analysis uses Last Observation Carried Forward (LOCF) method.||scores on a scale||Standard Error|Mean
151261|NCT00377260|Primary|The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment|The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on diaries completed at home by the child's parent.||AOM-SOS score||Standard Error|Mean
151262|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the follow-up visit.||parental satisfaction score||Standard Deviation|Mean
151263|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the end-of-therapy visit.||parental satisfaction score||Standard Deviation|Mean
151264|NCT00377260|Secondary|The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment|Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children whose parent reported a satisfaction score at the on-therapy visit.||parental satisfaction score||Standard Deviation|Mean
151265|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits|||Number
151266|NCT00377260|Secondary|The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment|At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits|||Number
151267|NCT00377260|Secondary|The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment|This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up.||antibiotic prescriptions||Standard Deviation|Mean
151364|NCT00375752|Secondary|Number of Patients With Breast-conserving Surgery||Every 6 months|The intent-to-treat (ITT) population included all patients of the safety population for whom at least one post-baseline assessment of tumor response according to the modified RECIST (local or central assessment) was available. During different time points, participants with observations at that timepoint were included in the analysis.||Participants|||Number
151268|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches <= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) & recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 & 3, & once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy|||participants|||Number
151269|NCT00377260|Primary|The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment|Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score >=3 was required to be enrolled in the study.|The first 7 days on therapy|The analysis was ITT. The number of participants is equal to the number of children randomized.||participants|||Number
151270|NCT00377260|Secondary|The Mean Number of Emergency Room Visits According to Treatment Assignment|At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits to ER||Standard Deviation|Mean
151271|NCT00377260|Secondary|The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment|At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed.|This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.|The analysis was ITT. The participants for analysis were the children with follow-up assessment visits.||visits to PCP||Standard Deviation|Mean
151272|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.||probability of effusion||Standard Deviation|Mean
151273|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the end-of-therapy visit.||probability of effusion||Standard Deviation|Mean
151274|NCT00377260|Secondary|The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment|For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the on-therapy visit.||probability of effusion||Standard Deviation|Mean
151275|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit||Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the follow-up visit.||participants|||Number
151276|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment|AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit.|Follow-up visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children with NP culture results at the follow-up visit.||participant|||Number
151277|NCT00377260|Secondary|The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment||End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children with NP culture results and results regarding penicillin susceptibility at the end-of-therapy visit.||participants|||Number
151379|NCT00375505|Secondary|Change in Estradiol (E2) From Baseline to Month 24|Change in Estradiol from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/L||Standard Deviation|Mean
151279|NCT00377260|Secondary|The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment|Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media.|We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.|The analysis was ITT. The number of participants equals the number of children randomized.||participants|||Number
151280|NCT00377260|Secondary|The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment|The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered.|The first 10 days of follow-up|The analysis was ITT. The participants for analysis were the children with follow-up.||times analgesic was administered||Standard Deviation|Mean
151281|NCT00377260|Secondary|The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased).|Before receiving 72 hours of study medication|The analysis was ITT. The number of participants equals the number of children with follow-up whose parent(s) recorded AM and/or PM symptom scores in the first 3 days of treatment.||Participants|||Number
151282|NCT00377260|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment|The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0.|During the first 7 days of therapy|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score post-enrollment in the first 7 days of therapy. The score was based on AM and PM diaries completed at home by the child's parent.||AOM-SOS score||Standard Deviation|Mean
151283|NCT00377260|Secondary|The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment|Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion.|End-of-therapy visit. The mean day for this visit was 11.6.|The analysis was ITT. The number of participants equals the number of children evaluated post therapy plus the number of children who met the criteria for clinical failure prior to the end of therapy.||participants|||Number
151284|NCT00377260|Secondary|The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment|Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both.|On-therapy visit. The mean day for this visit was 5.0.|The analysis was ITT. The number of participants equals the number of children followed at least 72 hours after the initial dose of study medication plus the number of children meeting the criteria for clinical failure less than 72 hours after the initial dose of study medication.||participants|||Number
151285|NCT00377234|Secondary|Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.|||||
151286|NCT00377234|Secondary|Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)|During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.|3 months|Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported.|||||
151598|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity|Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.||participants|||Number
151288|NCT00377234|Secondary|Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|within 6 months|mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment||percentage of participants|||Number
151289|NCT00377234|Primary|Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing|Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.|at 6 months|Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment||percentage of participants|||Number
151290|NCT00376961|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
151291|NCT00376961|Secondary|2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of death due to any cause or last contact|0-2 years|All eligible patients who started treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
151292|NCT00376961|Primary|2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)|Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
151293|NCT00376961|Secondary|Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment|All eligible patients who started treatment were included in the analysis.||participants|||Number
151294|NCT00376948|Secondary|pAKT (Pichia Anomala Killer Toxin) and NF (Nuclear Factor)-kappaB Activation|Tumor tissue collected from paraffin|At start of study||||||
151295|NCT00376948|Secondary|Toxicity|Toxicity evaluation using NCI-CTC (Common Terminology Criteria) v.3 criteria; CBC (complete blood count) with differential white cell and platelet counts; Serum sodium, potassium, chloride, bicarbonate, AST, ALT, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, and albumin; Serum CA 19-9|First day of each cycle||||||
151296|NCT00376948|Secondary|Response Duration, Time to Treatment Failure, and Time to Progression|Imaging tests (CT scan, CXR, MRI or imaging studies as clinically indicated|Every 8 weeks||||||
151297|NCT00376948|Secondary|Overall Objective Response Rate (Complete and Partial Response)|Imaging tests (CT scan, CXR [Chest X-Ray], MRI or imaging studies as clinically indicated|Every 8 weeks||||||
151298|NCT00376948|Primary|Median Overall Survival Estimate||at the conclusion of the study|||months||90% Confidence Interval|Median
151299|NCT00376948|Primary|Patients Alive||at 6 months|||participants|||Number
151300|NCT00376935|Secondary|Number of Death From Randomization to Week 24|Number of subjects died.|From randomization to week 24|||participants|||Number
151301|NCT00376935|Secondary|Grade 3 or 4 Lab Toxicities From Randomization to Week 24|Number of subjects had a grade 3 or 4 toxicity for laboratory abnormalities. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.|From randomization to study week 24|||participants|||Number
151302|NCT00376935|Secondary|Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.||cells/mm^3||Inter-Quartile Range|Median
151303|NCT00376935|Secondary|Change in CT Thymic Index From Randomization|CT thymic index was evaluated at randomization and study week 12, ranging from 0 to 5 whereby 0 means lack of thymic tissue and an organ entirely replaced by fat, 1 means barely recognizable thymic tissue, 2 means minimal soft tissue, 3 means obvious thymic tissue, 4 means moderate thymic tissue, 5 means thymic mass of possible concern for thymoma. Change in CT thymic index from randomization to study week 12 was calculated for participants with both evaluations. The number of participants in each change group was reported by treatment arm.|randomization, study week 12|Participants who had CT thymus evaluations at both randomization and study week 12.||participants|||Number
151304|NCT00376935|Secondary|Change in Naive CD4+ Cell Counts From Randomization||randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24|This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.||cells/mm^3||Inter-Quartile Range|Median
151307|NCT00376935|Primary|Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)|Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.|Pre-entry, entry, study week 12|Numbers presented use the intent-to-treat.||cells/mm^3||Inter-Quartile Range|Median
151308|NCT00376805|Secondary|Overall Median Number of Days Patients Alive After Treatment|Calculated median number of days of survival (patients alive days after treatment).|First Day of Treatment Until Death|||Days||95% Confidence Interval|Median
151309|NCT00376805|Secondary|Number of Patients Who Died While on Study|Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.|Within 100 days, After 100 days|||Participants|||Number
151310|NCT00376805|Secondary|Number of Patients by Disease Response|"Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:~Complete Response (CR: Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions of appearance of one or more new lesions~of clinical benefit (CB; stable disease for greater than 6 months."|6 Months, 1 Year|||Participants|||Number
151311|NCT00376805|Primary|Number of Patients Who Had Expansion of Natural Killer Cells|Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of >100 cells/ul of whole blood 14 days after infusion with <5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).|Day 14|||Participants|||Number
151312|NCT00376688|Primary|Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)|"Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.~Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;~Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits"|Up to 24 months|||percentage of participants|||Number
151313|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Emotional State Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."||Units on scale||Standard Deviation|Mean
151314|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Physical Condition Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."||Units on scale||Standard Deviation|Mean
151315|NCT00376675|Secondary|Anchor-based Minimally Important Difference in SGIC Overall Quality of Life Based on Mean Changes From Baseline to Week 4 on BFI Usual Fatigue|"Perceived treatment efficacy was measured by the Subject Global Impression of Change (SGIC). The SGIC is a 3-point item in which the patient rates the change in the overall status since beginning the study drug (ranging from very much better, moderately better, a little better, about the same, a little worse, moderately worse, to very much worse). The average change in patient fatigue scores for those participants who express a perceived change of a little better via the SGIC scores were calculated. BFI usual fatigue item score was translated into 0 to 100 point scale for the analysis, with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms)."|Baseline and Week 4|"All participants who have provided a baseline and week 4 BFI usual fatigue scores and a perceived change of a little better via SGIC scores."||units on a scale||Standard Deviation|Mean
151316|NCT00376675|Secondary|AUC of Other Fatigue Scores as Measured by Items of the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|Area under the curve (AUC) for the other fatigue items of the BFI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline BFI score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
151317|NCT00376675|Secondary|AUC of Overall Quality of Life (QOL) and QOL Domains as Measured by the Linear Analogue Self Assessment at Baseline and at Weeks 1-4|Linear Analogue Self Assessment (LASA) consists of 6 single-item numeric analogue scales. The AUC for the six-items at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline LASA score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
151319|NCT00376675|Secondary|AUC of Sleep Quality as Measured by the Pittsburgh Sleep Quality Index at Baseline and at Weeks 1-4|Pittsburgh Sleep Quality Index (PSQI) consists of 19 items and 7 scales. The AUC for the overall PSQI at baseline and at weeks 1-4 after being translated onto a 0 to 100 point scale was calculated. Higher scores are better.|Baseline to Week 4|All participants who have provided a baseline and one post-baseline PSQI score were evaluable for this analysis.||units on a scale * weeks||Standard Deviation|Mean
151320|NCT00376675|Secondary|Severity of Adverse Events as Measured by the Symptom Experience Diary Based on Mean Changes From Baseline to Week 4|The Symptom Experience Diary (SED) consists of 12 items. All scores were translated onto a 0-100 point scale, with 0 represent poor quality of life (QOL) or bad symptom and 100 is best QOL or no symptoms.The change in severity of adverse events was calculated as subtracting the item scores at baseline from the scores at week 4.|Baseline and Week 4|All participants who have provided a baseline and week 4 SED scores were evaluable for this analysis.||units on a scale||Standard Deviation|Mean
151321|NCT00376675|Primary|Prorated AUC of Total Fatigue as Measured by the Brief Fatigue Inventory (BFI) at Baseline and at Weeks 1-4|"The prorated area under the curve (AUC) for the usual fatigue question of the BFI at baseline and at weeks 1-4 after being translated onto a 0 (poor quality of life (QOL) or bad symptoms) to 100 (best QOL or no symptoms) point scale was calculated as the following:~For those completed 4 weeks item: AUC/4;~For those completed up to week 3 item: (AUC * 4) / 3;~For those completed up to week 2 item: AUC * 2;~For those completed up to week 1 item: AUC * 4;~The prorated AUC scores were then transformed onto 0 to 100 point scale with 0 (poor QOL or bad symptoms) and 100 (best QOL or no symptoms) for analysis."|Baseline to week 4|All participants meeting the eligibility criteria who have signed a consent form, started treatment, and provided a baseline and one post-baseline usual fatigue score were evaluable for this analysis.||units on a scale||Standard Deviation|Mean
151322|NCT00376558|Secondary|Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use|measurement of abstinence, measured as vouchers earned and clinical appointments attended using CRA|2x/week for 24 weeks|The number of subjects was determined from previous studies using CM/CRA||dollars||Standard Deviation|Mean
151323|NCT00376558|Primary|Change From Baseline in the Binding Potential of [11C]Raclopride|The relationship between Methylphenidate-induced Dopamine Release in the Striatum (Measured by Displacement of [11C]-Raclopride by Oral Methylphenidate) and Treatment Response (Measured Using Community Reinforcement Approach and Contingency Management) was studied. Dopamine Function was assessed by evaluation of endogenous Dopamine release over the course of treatment (i.e., at 3 months as compared to baseline). Endogenous Dopamine release is inversely related to the change in binding potential (delta BPND) of [11C]raclopride, in that a negative delta BPND, or increased displacement of [11C]raclopride, reflects an increase in the release of endogenous dopamine over the course of treatment.|baseline and 3 months|Analysis for change in binding potential (binding potential difference; at baseline versus stimulant induced binding potential) was done with 24 cocaine users since one of the subjects only underwent baseline scanning. However, treatment data for all 25 cocaine users was used.||ratio||Standard Deviation|Mean
151324|NCT00376532|Primary|MMP-9|Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment|||pg/ml||Standard Deviation|Mean
151325|NCT00376532|Primary|MMP-2|Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.|At time of enrollment|||pg/ml||Standard Deviation|Mean
151326|NCT00376506|Secondary|Quality of Life Patient Questionnaire|The SWAL-QOL (Swallowing Quality of Life) questionnaire was administered at baseline and every 3 months during the first year. The SWAL-QOL is a 44 item tool that measure 10 quality of life domains, i.e., food selection, burden, mental health, social functioning, fear, eating duration, eating desire, communication, sleep, and fatigue. Scores range from 0 to 100. A lower score indicates greater impairment.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
151327|NCT00376506|Secondary|Functional Oral Intake Scale (FOIS) for Dysphagia|The FOIS was administered at baseline and every 3 months post-treatment during the first year. The FOIS is a 7 point ordinal scale reflecting the functional oral intake of patients. A score of 1 indicates no oral nutrition; a score of 7 indicates all nutrition is taken orally.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
151328|NCT00376506|Primary|Swallowing Safety for 5 ml of Pudding|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|intention to treat||Units on a scale||Standard Deviation|Mean
151329|NCT00376506|Secondary|Penetration-Aspiration Scale for 5 ml Pudding|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 5 ml pudding, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
151330|NCT00376506|Secondary|Penetration-Aspiration Scale for 10 ml Thin Liquid|Every 3 months swallowing was measured using the Penetration-Aspiration (P/A) Scale. The P/A scale is an 8-point interval scale measuring the depth to which material passes into the airway and the patients cough response. A score of 0 indicates no penetration or aspiration. A score of 8 indicates the presence of aspiration with no cough response. A higher score indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The P/A Scale was scored by speech pathologists blinded to the identity of the patient, group, and time post training, from videotaped swallows.|Baseline and 12-months post-treatment|intention to treat||units on a scale||Standard Deviation|Mean
151331|NCT00376506|Primary|Swallowing Safety for 10 ml of Thin Liquid|Every 3 months swallowing safety was measured using the Swallowing Safety Scale (SSS). The SSS measures 11 swallowing variables including: the presence of residue in the valleculae, laryngeal vestibule, and/or pyriform sinuses, the presence of penetration arising from the oropharynx and/or the hypopharynx, the number of aspiration events arising from the oropharynx and/or the hypopharynx, response to aspiration, degree of esophageal entry, presence of regurgitation, and the presence of >1 swallow per bolus. Scores range from 0 (safe swallowing) to >5 (severely impaired swallowing safety). The maximum score is infinite as the number of occurrences of aspiration is counted in the total score. A higher score on the SSS indicates reduced swallowing safety. Swallows of 10 ml thin liquid, were captured during videofluoroscopy. The SSS was scored from videotaped swallows, by speech pathologists. The raters were blinded to the identity of the patient, group, and time post training.|Baseline and 12-months post-treatment|Intention to treat||units on a scale||Standard Deviation|Mean
151332|NCT00376363|Secondary|Visual Acuity|Snellen chart converted to logMAR (smaller logMAR values indicate better visual acuity logMar of 0 is Snellen 20/20; logMAR of 20/200 is 1.0)|5 years|"The failure rate is based on Kaplan Meier analysis of all patients enrolled (n=276).~The five-year intraocular pressure and visual acuity outcomes are based on those patients who received a five-year visit (n=174 for IOP; n=173 for visual acuity, 1 patient had missing data)"||logMAR||Standard Deviation|Mean
151333|NCT00376363|Primary|Failure Rate|5-year failure rate measured by Kaplan-Meier, defined as IOP>21 mm Hg or less than a 20% reduction below baseline on 2 consecutive study visits after 3 months, reoperation for glaucoma, loss of light perception, or removal of implant|5 years|Kaplan-Meier survival analysis||percent fail|||Number
151334|NCT00376363|Primary|Intraocular Pressure|intraocular pressure mmHg at 5 years|5 years|||mm Hg||Standard Deviation|Mean
151335|NCT00376259|Secondary|Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough|The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.|Week 96|||Proportion of Participants|||Number
151336|NCT00376259|Secondary|Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria|Undetectable HBV DNA = HBV DNA <300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.|12 week, 24 week, 48 week and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation for that timepoint.||Percentage of participants|||Number
151337|NCT00376259|Secondary|Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration|Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.|Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks|Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation.||Log10 Copies/mL||Standard Deviation|Mean
151338|NCT00376259|Primary|The Proportion of Participants Who Experienced Virologic Breakthrough|Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.|96 Weeks|This study was terminated early and no patients received 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.||Proportion of participants|||Number
151339|NCT00376168|Other Pre-specified|Change in Chitotriosidase|Change in Chitotriosidase from Baseline to Month 9|Baseline and Month 9|Intent to treat||nmol/ml/hr||Standard Deviation|Mean
151340|NCT00376168|Secondary|Change in Platelet Count|Change in Platelet count from Baseline to Month 9|Baseline and Month 9|Intent to treat||count/mm^3||Standard Deviation|Mean
151341|NCT00376168|Secondary|Change in Hemoglobin|Absolute change in Hemoglobin concentration from Baseline to Month 9|Baseline and Month 9|Intent to treat||g/dL||Standard Deviation|Mean
151342|NCT00376168|Secondary|Change From Baseline in Liver Volume|Calculated as percent change in liver volume from Baseline to 9 months|Baseline and 9 months|Intent to treat||percentage of change from baseline||Standard Deviation|Mean
151343|NCT00376168|Primary|Change From Baseline in Spleen Volume Measured by MRI.|Calculated as percent change in spleen volume from Baseline to 9 months|Baseline and 9 months|Intent to treat||percentage of change||Standard Deviation|Mean
151344|NCT00375999|Primary|Overall Survival||One year|||month||95% Confidence Interval|Median
151345|NCT00375973|Secondary|Number of Participants Who Discontinued Use of Treatment Due to Adverse Events|Paticipants who dropped out of the study because of intolerable adverse events.|Any time after randomization up to 12 weeks.|One patient in the duloxetine group did not have post-baseline data.||participants|||Number
151346|NCT00375973|Secondary|Number of Participants Who Discontinued the Study for Any Reason|Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance.|Any time after randomization up to 12 weeks.|||participants|||Number
151347|NCT00375973|Secondary|Patient Global Impression of Improvement (PGI-I)|Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.|baseline to endpoint at 12 weeks.|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
151348|NCT00375973|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S)|Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
151349|NCT00375973|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale|The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement.|baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
151350|NCT00375973|Secondary|Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score|The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 [no pain] to 10 [pain as bad a you can imagine] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity).|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
151351|NCT00375973|Primary|Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score|"The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.~The general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit."|Baseline to endpoint at 12 weeks|For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.||units on a scale||Standard Deviation|Mean
151352|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge.|Day 3|||participants|||Number
151353|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2|||participants|||Number
151354|NCT00375934|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1|||participants|||Number
151355|NCT00375934|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7).||minutes||95% Confidence Interval|Median
151356|NCT00375934|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|||participants|||Number
151357|NCT00375934|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hourse post single dose|||units on a scale||Standard Deviation|Mean
151358|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4).~Number of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results)."||minutes||95% Confidence Interval|Median
151359|NCT00375934|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
151360|NCT00375934|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2).||minutes||95% Confidence Interval|Median
151361|NCT00375934|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
151362|NCT00375934|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy|||units on a scale||Standard Deviation|Mean
151363|NCT00375752|Secondary|Change From Baseline in Tumor Size (Longest Diameter) at Month 6|Tumor size (sum of longest diameter)was analyzed based on the diameters values provided with the central review.|Baseline, Month 6|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.||cm||Standard Deviation|Mean
151393|NCT00375492|Secondary|Ratio of Triglycerides at Week 24 to Triglycerides at Baseline|Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0). Triglycerides measured in mmol/L.|baseline, Week 24|Intent to Treat population||Ratio||Standard Error|Geometric Mean
151365|NCT00375752|Secondary|Best RECIST Response Based on Central Review|Best response is defined as the best response the patients has reached during the 6 months of treatment. Response Evaluation Criteria in Solid Tumors (RECIST) has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet criteria.|6 Months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.||Participants|||Number
151366|NCT00375752|Primary|Tumor Response Rate (Complete Response (CR) or Partial Response (PR)) Based on MRI- or Mammography and/or Sonography According to Modified RECIST Criteria at Month 6|Sum of longest diameter for all target lesions was reported as baseline sum LD. Baseline sum LD was used as reference to characterize objective tumor response. Response Evaluation Criteria in Solid Tumors has 4 response categories. CR (complete response) = disappearance of all target lesions, PR (partial response)= 30% decrease in sum of longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD(stable disease)=small changes that do not meet criteria. Analysis was underpowered due to insufficient recruitment rate.|6 months|The modified intent-to-treat (mITT) population included all patients of the ITT population for whom at least one post-baseline assessment of tumor response according to modified RECIST made by central review was available.||percentage of participants||95% Confidence Interval|Number
151367|NCT00375713|Secondary|Global Improvement at Endpoint During the 14 Day Treatment Period|Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified ITT except 1 patient in levocetirizine group and 3 patients in cetirizine group who have missing values.||Participants|||Number
151368|NCT00375713|Secondary|Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period|Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.|At endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.||Units on a scale||Standard Error|Mean
151369|NCT00375713|Secondary|Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period|The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.|Baseline and at endpoint during the 14 day treatment period|All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.||Units on a scale||Standard Error|Mean
151370|NCT00375713|Primary|Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).|A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.|Day 7 and 14|The modified ITT population is defined as all randomized patients who received the study drug, except the patients who did not meet the entry criteria, took prohibited medication during the study period, did not have any available data for efficacy evaluation and who were enrolled with packing errors.||Participants|||Number
151371|NCT00375518|Primary|Determine the Postoperative Complications Found in Each Group|To determine whether one week of preventive therapy with atorvastatin prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.|one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery|||participants|||Number
151372|NCT00375505|Secondary|Change in Inhibin A and Inhibin B From Baseline to Month 24|Change in Inhibin A and Inhibin B from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||pg/ml||Standard Deviation|Mean
151373|NCT00375505|Secondary|Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24|Change in anti-Mueller hormone (AMH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
151374|NCT00375505|Secondary|Change in Vitamine D From Baseline to Month 24|Change in Vitamine D from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
151375|NCT00375505|Secondary|Change in Parathyroid Hormone (PTH) From Baseline to Month 24|Change in Parathyroid Hormone (PTH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||pg/ml||Standard Deviation|Mean
151376|NCT00375505|Secondary|Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24|Change in Sex Hormone binding globulin (SHGB) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||nmol/l||Standard Deviation|Mean
151377|NCT00375505|Secondary|Change in Testosterone From Baseline to Month 24|Change in Testosterone from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
151378|NCT00375505|Secondary|Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24|Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||mIU/ml||Standard Deviation|Mean
151380|NCT00375505|Secondary|Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24|Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/ml||Standard Deviation|Mean
151381|NCT00375505|Secondary|Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24|CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||ng/mL||Standard Deviation|Mean
151382|NCT00375505|Secondary|Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)|Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||m/s||Standard Deviation|Mean
151383|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||dB/MHz||Standard Deviation|Mean
151384|NCT00375505|Secondary|Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)|Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||m/s||Standard Deviation|Mean
151385|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||percentage change||Standard Deviation|Mean
151386|NCT00375505|Secondary|Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24|Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||Percentage Change||Standard Deviation|Mean
151387|NCT00375505|Primary|Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4)|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||percentage change||Standard Deviation|Mean
151388|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score|Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||Z-score||Standard Deviation|Mean
151389|NCT00375505|Primary|Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score|Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||T-score||Standard Deviation|Mean
151390|NCT00375505|Primary|Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24|Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.|baseline, month 24|ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.||Z-score||Standard Deviation|Mean
151391|NCT00375492|Secondary|Rate of Hypoglycemic Events|Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).|24 weeks|Intent to Treat population||events per patient per year||Standard Error|Least Squares Mean
151392|NCT00375492|Secondary|Number of Participants With Hypoglycemic Events During the Study|Number of participants experiencing one or more events of hypoglycemia at any point in the study|Baseline to 24 weeks|Intent to Treat population||participants|||Number
151820|NCT00371397|Primary|Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)|Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).|Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30||||||
151395|NCT00375492|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24|Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0). LDL cholesterol measured in mmol/L|baseline, Week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
151396|NCT00375492|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24|Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0). HDL measured as mmol/L.|baseline, Week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
151397|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline|Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity. HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia. HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population||Ratio||Standard Error|Geometric Mean
151398|NCT00375492|Secondary|Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline|Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0). HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency. HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia. HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation). The higher the percent the better for the participant.|baseline, Week 24|Intent to Treat population||Ratio||Standard Error|Geometric Mean
151399|NCT00375492|Secondary|Change From Baseline in Waist Circumference at Week 24|Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0). Waist measured in centimeters (cm).|baseline, Week 24|Intent to Treat population||cm||Standard Error|Least Squares Mean
151400|NCT00375492|Secondary|Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24|Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0). Fasting Glucose measured in millimoles per liter (mmol/L).|baseline, Week 24|Intent to Treat population||mmol/L||Standard Error|Least Squares Mean
151401|NCT00375492|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0). HbA1c is measured as percent (%) of hemoglobin.|baseline, Week 24|Intent to Treat population||percent hemoglobin||Standard Error|Least Squares Mean
151402|NCT00375492|Primary|Change From Baseline in Body Weight|Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0). Body weight measured in kilograms (k).|Baseline, Week 24|Intent to Treat population||kg||Standard Error|Least Squares Mean
151403|NCT00375427|Secondary|Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score|ECOG Performance Score has 4 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. Outcome is given as median score for participants at Baseline and 3, 6 , 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.||score on a scale||Full Range|Median
151404|NCT00375427|Secondary|Use Of Analgesic Medications According to the Analgesic Score Scale|"The analgesic score used for this study is modified from the Radiation Therapy Oncology Group (RTOG) analgesic score scale. The scale represents type of medication administered from 0 to 4 where:~0 = None~= Minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.)~= Tranquilisers, antidepressants, muscle relaxants, and steroids~= Mild narcotics (oxycodone, meperidine, codeine, etc.)~= Strong narcotics (morphine, hydromorphone, etc.) The outcome is given a the median score for the participants at Baseline and 3, 6, 9 and 12 months of treatment"|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.||score on a scale||Full Range|Median
151405|NCT00375427|Secondary|Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value|Pain intensity at rest and on movement is rated by the patient by means of a validated 6-point Verbal Rating Scale (VRS) and refers to the pain which occurred during the last week before the assessment. Median score value is the median of all the observed scores (none=0, very mild=1, mild=2, moderate=3, severe=5 and very severe=6) at each time point.|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients.||score on a scale||Full Range|Median
151406|NCT00375427|Secondary|Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire|Bone pain was assessed by means of a pain score obtained using the Brief Pain Inventory (BPI) questionnaire. The BPI can produce three pain scores: worst pain, a composite pain score, and a pain interference score. The composite pain score, which is the average of questions 3, 4, 5 and 6 of the questionnaire was used in this study. Pain was rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The outcome is given as the median score for participants at baseline, and 3, 6, 9 and 12 months of treatment|At Baseline, Month 3, Month 6, Month 9 and Month 12|Intent-to-treat (ITT) population will include all randomized patients. All ITT patients with BPI questionnaire filled up at baseline were included.||score on a scale||Standard Deviation|Mean
151407|NCT00375427|Secondary|Percentage of Participants Skeletal Related Event (SRE) Free|"Percentage of participants SRE free is defined as the Kaplan-Meier estimate of participants free of any Skeletal Related Events(SRE) at each time point.~Skeletal Related Events (SREs) are:~pathologic bone fracture; non-vertebral and vertebral~spinal cord compression identified by X-rays~surgery to bone both curative and prophylactic~radiation therapy to bone (palliative, therapeutic or prophylactic)~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level which is symptomatic and requires treatment other than rehydration."|12 months|Intent-to-treat (ITT) population will include all randomized patients.||Percentage of participants||95% Confidence Interval|Number
151408|NCT00375427|Secondary|Median Time to First Skeletal Related Event(s) (SRE)|Median Time to first skeletal related event (SRE) is defined as the time from randomization to the date of first occurrence of any SRE which includes at least one of the following: radiation therapy to bone, pathologic bone fracture, spinal cord compression, surgery to bone, and hypercalcemia of malignancy (HCM). Due to the few numbers of SRE, Kaplan-Meier estimate never reaches a failure probability >=25%; so median time, 25th and 75th percentiles are not determined.For this reason only the estimated percentage of patient SRE free are reported at each time point.|12 month|||Day|||Number
151409|NCT00375427|Secondary|Annual Incidence of Any Skeletal Related Events (SREs)|"Skeletal Related Events (SREs) are defined as a:~pathologic bone fracture such as non-vertebral and vertebral~spinal cord compression identified by X-rays evidence~surgery to bone both curative and prophylactic~radiation therapy to bone including palliative, therapeutic or prophylactic~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration. Annual incidence for each SRE was computed in the same way as annual overall SMR."|12 months|Intent-to-treat (ITT) population will include all randomized patients.||Number of SRE per Year||Standard Deviation|Mean
151410|NCT00375427|Secondary|Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)|"Skeletal Related Events (SREs) are defined as a:~pathologic bone fracture such as non-vertebral and vertebral compression fractures~spinal cord compression identified by positive diagnosis documented by X-ray evidence~surgery to bone both curative and prophylactic~radiation therapy to bone including palliative, therapeutic or prophylactic~hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration."|12 month|Intent-to-treat (ITT) population will include all randomized patients.||Percentage of Participants|||Number
151411|NCT00375427|Primary|Annual Overall Skeletal Morbidity Rate (SMR)|"The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio “days of observation period / 365.25”, for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.~SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit."|12 months|Intent-to-treat (ITT) population will include all randomized patients.||Number of Skeletal Events per Year||Standard Deviation|Mean
151412|NCT00375219|Secondary|Kaplan-Meier Estimates for Overall Survival|Overall survival is defined as the time from the initiation of treatment until death from any cause or the last day of participant contact or evaluation for participants that were lost to follow-up. Participants were censored t the last recorded contract or evaluation when a participant was alive at time of analysis. A quarterly phone survey was conducted to collect survival data for participants who discontinued from the study.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
151413|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Disease Progression|Time to disease progression is defined as the time from the initiation of treatment until the onset date of death, the development of CML accelerated phase or blast phase, or the loss of complete hematologic response or major cytogenetic response, whichever came first. Participants were censored only if they did not have progression or if they discontinued treatment for reasons other than AE, progression or death.|up to 4 years|Intent to treat||months||95% Confidence Interval|Median
151414|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Cytogenetic Response|Duration of response is defined as the time from first reported date of cytogenetic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response||months||Full Range|Median
151415|NCT00375219|Secondary|Kaplan-Meier Estimates for Duration of Best Hematologic Response|Duration of response is defined as the time from first reported date of hematologic response until the earliest date of objective evidence of disease progression, relapse or death. Data was censored at the last examination date for participants with ongoing response or participants who discontinued treatment for reasons other than adverse event, disease progression or death.|up to 4 years|Intent to treat population of participants who had a response||months||Full Range|Median
151416|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Cytogenetic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.~Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells."|up to 3 years|Intent to treat||months||95% Confidence Interval|Median
151417|NCT00375219|Secondary|Kaplan-Meier Estimates for Time to Onset of Best Hematologic Response|"Time to onset was analyzed using Kaplan-Meier estimates. Participants who did not achieve a response are censored at their last visit day.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful."|Day 1 up to Month 6|Intent to treat||months||95% Confidence Interval|Median
151418|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Cytogenetic Response||Day 1 up to 22 months|Intent to treat population of participants who had a cytogenetic response||treatment cycles||Full Range|Median
151419|NCT00375219|Secondary|Number of Treatment Cycles Needed to Achieve Best Hematologic Response|Induction therapy was administered for 14 consecutive days for each 28 days cycle, for up to 6 cycles. All treatment arms were given omacetaxine mepesuccinate via subcutaneous (SC) administration at 1.25 mg/m^2 twice a day (BID) for the 14 consecutive days.|Day 1 up to Month 6|Intent to treat population of participants who had a response to treatment||treatment cycles||Full Range|Median
151821|NCT00371397|Primary|Immune Function: Tumor Necrosis Factor-alpha (TNF-α)|Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30||||||
151420|NCT00375219|Secondary|Percentage of Participants With the Largest Percentage Reduction From Baseline of T315I Mutated BCR-ABL|Summarization is based on the best of the individual response assessments. Not assessable indicates that the participant either had no baseline assessment or the % mutation could not be determined in the post-baseline assessment(s).|Day 1 up to Month 9|Intent to treat population of participants with post-baseline assessment of T315I mutated BCR ABL||percentage of participants||95% Confidence Interval|Number
151421|NCT00375219|Secondary|Percentage of Participants With Extramedullary Disease (EMD) at Baseline Achieving a Clinical Response|"Clinical response was defined by disease phase and based on evaluations by the independent Data Monitoring Committee (DMC).~Chronic Phase subgroup: achieving a complete hematologic response and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~Accelerated Phase and Blast Phase subgroups: achieving complete hematologic response, no evidence of leukemia, return to chronic phase, and/or major cytogenetic response (complete cytogenetic response or partial cytogenetic response, confirmed or unconfirmed).~The percentage of participants achieving response with extramedullary disease at Baseline was to be summarized, if the sample size was sufficient. This analysis was not done as the sample was ultimately insufficient"|Day 1 up to Month 9|Intent to treat population of study participants who had extramedullary disease at baseline. Analysis not performed due to insufficient sample size.|||||
151422|NCT00375219|Secondary|Percentage of Participants in Each Hematologic Response Category|"Complete Response (CHR)~Chronic phase must last at least 8 weeks: WBC <10*10^9/liter, platelets <450*10^9/liter, myelocytes + metamyelocytes <5% in blood, no blasts or promyelocytes in blood, <20% basophils in peripheral blood, no extramedullary involvement.~Accelerated and Blast phase must last at least 4 weeks: absolute neutrophil count 1.5*10^9/liter, platelets 100*10^9/liter, no blood blasts, bone marrow blasts <5%, no extramedullary disease.~Partial Response - CHR plus one or more of the following:~Persistence of splenomegaly with a reduction of ≥50% from pre-treatment~Platelets > 450*10^9/L~Presence of immature cells in the peripheral blood~5% to 25% blasts in the bone marrow~If extra-medullary disease pre-treatment, reduction by ≥50% Hematologic Improvement - CHR, except allowing persistent thrombocytopenia (<100*10^9/L), and a few immature cells No evidence of leukemia: Morphologic leukemia-free state, defined as <5% bone marrow blasts."|Day 1 up to Month 6|Intent to treat||percentage of participants|||Number
151423|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene ABL|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene ABL. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
151424|NCT00375219|Secondary|Percentage of Participants With Major Molecular Response (MMR) Representing the Degree of Suppression of BCR-ABL Transcript Levels Using the Housekeeping Gene GUS|MMR is defined as a ratio of BCR-ABL/standard gene of less than 0.1% according to the international scale. BCR-ABL is a fusion gene of the breakpoint cluster region [BCR] gene and Abelson proto-oncogene [ABL] genes). This analysis used the standard gene GUS. Analysis was performed by quantitative reverse transcription polymerase chain reaction (qRT-PCR) of peripheral blood.|Day 1 up to Month 6|Intent to treat population of participants who had evaluable samples. Participants with no data for these analyses either had degraded samples or the samples were missing.||percentage of participants||95% Confidence Interval|Number
151425|NCT00375219|Secondary|Percentage of Participants in Each Cytogenetic Response Category Representing the Degree of Suppression of the Philadelphia Chromosome (Ph+)|"Cytogenetic response categories:~Complete: 0% Ph+ cells~Partial: >0%-35% Ph+ cells~Minor: >35%-65% Ph+ cells~Minimal: >65%-95% Ph+ cells~No Response: >95% Ph+ cells~Unevaluable: <20 metaphases were examined and/or response could not be assigned"|Day 1 up to Month 9|Intent to treat||percentage of participants|||Number
151426|NCT00375219|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Subpopulation and Total|"TEAE are any untoward events that were newly occurring or worsening from Baseline.~Treatment related toxicity was considered by the investigator to be unrelated, possibly, probably or unknown related to study drug.~Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death.~A serious adverse event (SAE) is any untoward medical occurrence that is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.~A participant is only counted once in each category (at worst severity or strongest relationship)."|up to 3 years|Intent to treat||participants|||Number
151427|NCT00375219|Primary|Percentage of Participants Achieving a Major Cytogenetic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Major cytogenetic response includes complete or partial response. Both confirmed and unconfirmed major cytogenetic response is considered meaningful.~Unconfirmed response is based on a single bone marrow cytogenetic evaluation for participants where a confirmatory evaluation is not available.~Complete response shows 0% Philadelphia chromosome positive (Ph+) cells. A partial response shows >0% - 35% Ph+ cells.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
151580|NCT00373360|Secondary|Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied.|Baseline and Week 8|||participants|||Number
151428|NCT00375219|Primary|Percentage of Participants Achieving an Overall Hematologic Response by Subpopulation and Total Population|"Subpopulations reflect chronic myeloid leukemia (CML) phases at the time of enrollment: chronic, accelerated, and blast phase. Primary endpoints as adjudicated by the Data Monitoring Committee were used for the primary analyses.~Overall hematologic response for chronic phase participants includes confirmed complete hematologic response (CHR). Overall hematologic response for accelerated or blast phase participants includes confirmed complete hematologic response (CHR), no evidence of leukemia (NEL), or return to chronic phase (RCP). Hematologic response must last >= 8 weeks to be considered meaningful.~Response rates by disease phase were examined relative to an a priori value of 2.5% using a one-sided lower 95% exact binomial confidence limit. If the lower limit from the one-sided lower 95% confidence limit exceeds 2.5%, the observed response rate will have exceeded the minimum threshold required to demonstrate efficacy."|Day 1 up to 6 months|Intent to treat population||percentage of participants||95% Confidence Interval|Number
151429|NCT00374907|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|116 weeks|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.||participants|||Number
151430|NCT00374907|Other Pre-specified|Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|116 weeks|Treated participants||participants|||Number
151431|NCT00374907|Secondary|Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized Participants with both a baseline and post-baseline value (up to Week 12).||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
151432|NCT00374907|Primary|Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12|Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.|Baseline, Week 12|Randomized participants with both a baseline and post-baseline value (up to Week 12).||Percent Change (Percentage of Baseline)||95% Confidence Interval|Geometric Mean
151433|NCT00374868|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 620 days)|20 patients were censored.||days||Standard Error|Mean
151434|NCT00374868|Secondary|Progression-Free Survival|Defined as the time from study enrollment until disease progression or death from any cause.|baseline to measured progressive disease (up to 620 days)|11 patients were censored||days||95% Confidence Interval|Median
151435|NCT00374868|Secondary|Time to Treatment Failure (TTF)|Time from study enrollment to first observation of disease progression, death from any cause, or early discontinuation of treatment (including toxicity or if patient had stable disease after 4 cycles). TTF was censored at date of last follow-up visit for patients who did not discontinue early, who were still alive, and who had not progressed.|baseline to stopping treatment (up to 620 days)|1 patient was censored||days||95% Confidence Interval|Median
151436|NCT00374868|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|baseline to measured progressive disease (up to 620 days)|19 patients were censored||days||Standard Error|Mean
151437|NCT00374868|Secondary|Duration of Stable Disease|Defined as time from study enrollment to the first progression of disease, complete response, partial response, or death from any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.|time of no response or progression (up to 620 days)|1 patient was censored.||days||95% Confidence Interval|Median
151438|NCT00374868|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|time of response to progressive disease (up to 620 days)|10 patients were censored.||days||Standard Error|Mean
151439|NCT00374868|Secondary|Time to Response|Defined as time from study enrollment to the first Complete Response or Partial Response (using RECIST criteria). Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.|baseline to response (up to 620 days)|16 patients were censored.||days||Standard Error|Mean
151581|NCT00373360|Secondary|Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8|Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more.|Baseline and Week 8|||participants|||Number
151440|NCT00374868|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 620 days)|||participants|||Number
151441|NCT00374842|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.|From study start to study end, from Day 0 to Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
151442|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.|Within the 30-day follow-up period (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
151443|NCT00374842|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
151444|NCT00374842|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.|Within the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
151445|NCT00374842|Primary|Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Fold increase||95% Confidence Interval|Geometric Mean
151446|NCT00374842|Primary|Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.|At Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subject|||Number
151447|NCT00374842|Primary|Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.|A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||Subject|||Number
151489|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|Endpoint (12 weeks)|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
151448|NCT00374842|Primary|Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.|Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.|At Day 0 and at Day 21.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.||HIU||95% Confidence Interval|Geometric Mean
151449|NCT00374803|Secondary|GI Toxicities|Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)|12 months|||participants|||Number
151450|NCT00374803|Secondary|Incidence of Post Transplant Infections|Incidence of post transplant infections that resulted in hospitalization|12 months|||participants|||Number
151451|NCT00374803|Secondary|Renal Function at 12 Months|Renal function measured by serum creatinine (SCr) at 12 months post-transplant|12 months|||mg/dL||Standard Deviation|Mean
151452|NCT00374803|Secondary|Patient and Allograft Survival 12 Months|Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.|12 months|||participants|||Number
151453|NCT00374803|Primary|Incidence of All Biopsy Proven Acute Rejection.|Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine|12 months|||Participants|||Number
151454|NCT00374543|Primary|Hamilton Anxiety Rating Scale (HAM-A)|"The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.~Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks|Zero participants were analyzed because recruitment was very low. Due to this, we felt any analysis done would not be usable for accurate analyses.|||||
151455|NCT00374543|Secondary|Clinical Global Impression of Improvement (CGI-I)|"A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement.~Due to study termination, there are not results for primary and secondary outcome measures."|8 weeks||||||
151456|NCT00374335|Primary|Presence of Hepatic Hemangiomas on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years||||||
151457|NCT00374335|Secondary|Risk Factors Associated With the Development of Hepatic Hemangiomas|Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound|2 years|||participants|||Number
151458|NCT00374335|Primary|Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound|The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound|2 years|||participants|||Number
151459|NCT00374322|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings|12-lead ECG measurements were taken at Screening and at study conclusion/withdrawal. The number of participants with normal, abnormal clinically significant (CS), and abnormal not clinically significant (NCS) ECG findings, as classified by the investigator, were summarized. Participants with missing values were categorized as missing. Data for the primary analysis (conducted in 2011) are reported.|Screening and Month 12/Early Withdrawal Visit|SP. Only those participants (par.) available at the specified time points were analyzed. Two par. were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm.||Participants|||Number
151460|NCT00374322|Secondary|Number of Participants Experiencing Primary or Secondary Cardiac Events|A cardiac event is classified as a primary cardiac endpoint (PCE) or a secondary cardiac endpoint (SCE). PCE is defined as: cardiac death (cardiac death due to heart failure, myocardial infarction, or arrhythmia;or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event); severe symptomatic congestive heart failure (CHF) (as per New York Heart Association [NYHA] Class III or IV and an absolute decrease in left ventricular ejection fraction [LVEF] of more than 10 percentage points from Baseline and to a left ventricular ejection fraction [LVEF] value below 50%). SCE is defined as asymptomatic or mildly symptomatic cardiac events (NYHA Class I or II) and a significant decrease in LVEF, defined as an absolute decrease in LVEF of more than 10 percentage points from Baseline and to an LVEF value below 50%.|From the date of randomization up to 12 months|Safety Population (SP). Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.||Participants|||Number
151461|NCT00374322|Secondary|Number of Participants With Non-laboratory Toxicities of the Indicated Toxicity Grades|"Non-laboratory toxicities are defined as adverse events (AEs). The number of partcipants with any treatment-emergent AE of the indicated toxicity grade are summarized. Toxicity grading was according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 as follows: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life threatening; Grade 5=death. The events that were not given a toxicity grade are categorized as Not Applicable."|From the first dose of study treatment up to 12 months|Safety Population. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported.||Participants|||Number
151822|NCT00371397|Primary|Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)|Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.|Day 1 8:30, 11:35, 13:10. Day 2 7:30||||||
151462|NCT00374322|Secondary|Number of Participants With Clinical Chemistry Values Outside the Reference Range for the Indicated Parameters|"The clinical chemistry parameters assessed were: alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), aspartate amino transferase (AST), bicarbonate, blood urea nitrogen (BUN), bone alkaline phosphatase (Bone ALP), calcium, chloride, creatinine, creatinine clearance (Cr. Clearance), creatinine clearance estimated (Cr. Clrnc. est.), glucose, potassium, sodium, total bilirubin (Total Bln), total protein, urea, and uric acid. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) was presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm."|At Baseline and every 6 weeks thereafter up to Month 12/Early Withdrawal Visit|Safety Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.||Participants|||Number
151463|NCT00374322|Secondary|Number of Participants With Hematology Values Outside the Reference Range for the Indicated Parameters|"The hematology parameters assessed were: basophils (Bs) in giga (10^9) per liter (GI/L) and in percentage (%), eosinophils (Eo) in GI/L and %, hematocrit, hemoglobin, lymphocytes (Lmph) in GI/L and %, monocytes (Mono) in GI/L and %, platelet count, Red Blood Cell (RBC) count, total neutrophil count (TNC) in GI/L and %, and White Blood Cell (WBC) count. The Baseline (BL) value is the last available pre-treatment result recorded. Any post-Baseline value was based on results recorded at any scheduled or unscheduled post-Baseline visits. The prevalence of values lying outside the reference (ref.) range (high or low) is presented for BL and any post-Baseline (APBL) visit. Two participants were randomized to placebo but received lapatinib; therefore, they are included in the lapatinib treatment arm. Data for the primary analysis (conducted in 2011) are reported."|At Baseline and every 3 months thereafter up to Month 12/Early Withdrawal Visit|Safety Population (SP): all randomized participants (par.) who received >=1 dose of randomized treatment. Only those par. available (n=X, X in the category titles) at the specified time points were analyzed. Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP.||Participants|||Number
151464|NCT00374322|Secondary|Change From Baseline in the SF-36 v2 Domain Scores for Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) perceptions, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain is scored from 0 (poorer health) to 100 (better health); higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
151465|NCT00374322|Secondary|Change From Baseline in SF-36 v2 Scores for the Mental Component Summary (MCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The MCS score is a summary score representing overall mental health, which is derived from the 8 domain scores. As with each domain score, the MCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the LOCF method. The scores were analyzed using an ANCOVA model adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
151466|NCT00374322|Secondary|Change From Baseline in Short Form-36 Version 2 (SF-36 v2) Scores for the Physical Component Summary (PCS)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The PCS score is a summary score representing overall physical health, which is derived from the 8 domain scores. As with each domain score, the PCS score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Missing post-Baseline data were imputed using the last observation carried forward (LOCF) method. The scores were analyzed using an analysis of covariance (ANCOVA) model, adjusting for Baseline sub-scale score, treatment, and country. Positive changes from Baseline indicate improvement.|Baseline, Month 6, Month 12, and every 6 months after discontinuation of study treatment for 24 months (up to a maximum of 3 study years)|ITT Population (primary analysis [conducted in 2011]). Only those participants available (represented as n=X, X in the category titles) at the specified time points were analyzed.||Scores on a scale||Standard Error|Least Squares Mean
151520|NCT00373685|Other Pre-specified|Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization|PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists [H2RA], misoprostol, sucralfate, and others such as antacids) utilization.|Baseline through week 24 or ET|ITT; any randomized participant who received at least one dose of study medication; N= number of evaluable participants analyzed||Percentage of participants|||Number
151467|NCT00374322|Secondary|Number of Participants With Any Recurrence of the Initial Disease, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence and contralateral breast cancer, including ductal carcinoma in situ; or death from any cause without a prior event. Participants who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Participants who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.||Participants|||Number
151468|NCT00374322|Secondary|Modified Disease-free Survival (MDFS)|Modified disease recurrence=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause. The date of the event=the earliest date of the occurrence of any of the following events: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including DCIS; death from any cause without a prior event. MDFS was not calculated; data are presented as the number of participants with any recurrence of the initial disease, contralateral breast cancer, or death (disease-free survival) in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of an objective disease recurrence, contralateral breast cancer, or death from any cause (assessed up to 6 years)||||||
151469|NCT00374322|Secondary|Number of Participants With CNS Recurrence|The number of participants experiencing a CNS recurrence was summarized.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])|ITT Population. Data for the end-of-study analysis (conducted in 2013) are reported.||Participants|||Number
151470|NCT00374322|Secondary|Time to Central Nervous System (CNS) Recurrence|Time to CNS recurrence is defined as the interval between the date of randomization and the date of the occurrence of a CNS recurrence if noted as part of the participant's first recurrence. Time to CNS recurrence was not calculated; data are presented as the number of participants with CNS recurrence in the subsequent outcome measure table.|From the date of randomization until the date of the first occurrence of a CNS recurrence (assessed up to 6 years [1 year of treatment and 5 years of follow-up; median of 5.3 years for final analysis])||||||
151471|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Distant Recurrence-free Survival (Time to Distant Recurrence)|Distant recurrence (metastatic disease) is defined as a tumor in any area of the body not including those defined as local or regional recurrence. Sites of distant recurrence include: skin, subcutaneous tissue, and lymph nodes (excluding those described for local and regional recurrence); bone marrow; skeletal; lungs and pleural; ascites and pleural effusions; liver and other viscera; and central nervous system (CNS). Time to distant recurrence is defined as the interval between the date of randomization and the date of the first occurrence of a distant recurrence.|From the date of randomization until the date of the first occurrence of a distant recurrence (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.||Percentage of participants|||Number
151472|NCT00374322|Secondary|Percentage of Participants With the Indicated Period of Recurrence-free Survival (Time to First Recurrence)|Recurrence is defined as experiencing a recurrence of initial disease or contralateral breast cancer after randomization. Time to first recurrence is defined as the interval between the date of randomization and the date of the first occurrence of an objective disease recurrence or contralateral breast cancer. Time to first recurrence included the first occurrence at one of the following sites as an event: local recurrence following mastectomy; local recurrence in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ (DCIS).|From the date of randomization until the date of the first occurrence of an objective disease recurrence or contralateral breast cancer (assessed up to 6 years; 1 year of treatment and 5.3 years of follow-up [median of 5 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.||Percentage of participants|||Number
151473|NCT00374322|Secondary|Number of Participants Who Died (Overall Survival)|Overall Survival (OS) is defined as the time from randomization until death from any cause. Data are presented as the number of participants who died. For participants who did not die, time to death was censored at the last date the participant was known to be alive.|From the date of randomization until death from any cause (assessed up to 6 years; 1 year of treatment and 5 years of follow-up [median of 5.3 years for final analysis])|ITT Population. Data for the primary analysis (conducted in 2011) are reported.||Participants|||Number
151474|NCT00374322|Primary|Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS])|DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast); death from any cause without a prior event. Par. who started additional anti-cancer adjuvant therapy prior to the recurrence of their disease were to be censored. Par. who did not withdraw from the study and did not experience a specified event or death were to be censored (follow-up ongoing) at the last visit date available at which progression was assessed.|From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis])|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of randomized treatment (lapatinib or placebo). Data for the end-of-study analysis (conducted in 2013) are reported.||Participants|||Number
151475|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis||seconds||Standard Deviation|Mean
151476|NCT00374244|Secondary|Trail Making Test: Trail B|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Baseline|Intent to Treat Analysis||seconds||Standard Deviation|Mean
151477|NCT00374244|Secondary|Trail Making Test: Trail A|"The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. ( Arnett, James A.; Seth S. Labovitz (1995). Effect of physical layout in performance of the Trail Making Test. Psychological Assessment 7 (2): 220–221. doi:10.1037/1040-3590.7.2.220. Retrieved 2012-02-22.)~Part A is used primarily to examine cognitive processing speed. Part B, in which the subject alternates between numbers and letters, is used to examine executive functioning. (Tombaugh, T.N.T.N (2004). Trail Making test A and B: Normative Data Stratified by Age and Education. Archives of Clinical Neuropsychology : The Official Journal of the National Academy of Neuropsychologists 19 (2): 203–214. doi:10.1016/s0887-6177(03)00039-8. Retrieved 2012-01-10.)"|Endpoint (12 weeks)|Intent to Treat Analysis||seconds||Standard Deviation|Mean
151478|NCT00374244|Secondary|Trail Making Test: Trail A|Working memory by Digit Span and Letter Number Sequencing, and attention/executive functions were measured by the Trail Making Test (Parts A and B). This is an assessment of attention/executive function, it does not have an interpret-able range of scores like a traditional scale. Subjects makes trails on paper against time.|Baseline|Intent to Treat Analysis||seconds||Standard Deviation|Mean
151479|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis||words||Standard Deviation|Mean
151480|NCT00374244|Secondary|Verbal Learning and Memory: List B|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List B: Single Trial. This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis||words||Standard Deviation|Mean
151481|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Endpoint (12 weeks)|Intent to Treat Analysis||words||Standard Deviation|Mean
151482|NCT00374244|Secondary|Verbal Learning and Memory: List A|Verbal learning and memory were assessed by the Rey Auditory Verbal Learning Test (RAVLT) List A: Total Trials (1-5). This assessment consists of a list of words that the subject repeats back, it does not have an interpret-able range of scores like a traditional scale. Scores are based on number of words repeated back.|Baseline|Intent to Treat Analysis||words||Standard Deviation|Mean
151483|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Endpoint (12 weeks)|Intent to Treat Analysis||units on a scale||Standard Deviation|Mean
151484|NCT00374244|Secondary|Processing Speed|Processing speed was assessed using using Digit Symbol Coding from the Wechsler Adult Intelligence Scale, Revised (WAIS-R). The tool is used for the assessment of processing speed. The range of scores is 0 to 100- with the higher number indicating greater performance.|Baseline|Intent to Treat Analysis||units on a scale||Standard Deviation|Mean
151485|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Endpoint (12 weeks)|Intention to Treat||ms||Standard Deviation|Mean
151486|NCT00374244|Secondary|QTc|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms.|Baseline|Intention to Treat||ms||Standard Deviation|Mean
151487|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Endpoint (12 weeks)|Intent to Treat Analysis||words||Standard Deviation|Mean
151488|NCT00374244|Secondary|Verbal Fluency|Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance.|Baseline|Intent to Treat Analysis||words||Standard Deviation|Mean
151490|NCT00374244|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0‐5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.|baseline|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
151491|NCT00374244|Secondary|CGI Improvement Scale (CGI‐I)|"CGI Improvement Scale (CGI‐I) higher rating correlates with worsening of condition (vs. improvement with lower rating). The CGI-I is scored from 1 to 7 where 1 = 'very much improved' and 7 = 'very much worse'. Clinicians are asked to rate total improvement in the following manner: ...in your judgement, it is due entirely to drug treatment. Compared to his condition at admission to the project, how much has he changed?"|Endpoint (12 weeks)|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
151492|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|Endpoint (12 weeks)|Analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
151493|NCT00374244|Secondary|CGI Severity of Illness Scale (CGI‐S)|CGI Severity of Illness Scale (CGI‐S) assesses severity of illness on 1‐7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill.|baseline|Analyzes intent to treat.||units on a scale||Standard Error|Least Squares Mean
151494|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Endpoint (12 weeks)|Subjects were analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
151495|NCT00374244|Primary|Brief Psychiatric Rating Scale (BPRS) Total Score|The Brief Psychiatric Rating Scale (BPRS) is an 18‐item instrument. The items are anchored on a 7‐point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.|Baseline|Subjects were analyzed intent to treat.||units on a scale||Standard Error|Least Squares Mean
151496|NCT00374231|Other Pre-specified|Time Post Transplant Corticosteroid Withdrawal|The mean days from post transplant corticosteroid withdrawal.|12 months|||days||Standard Deviation|Mean
151497|NCT00374231|Secondary|Patient Survival.||12 months|||participants|||Number
151498|NCT00374231|Primary|Incidence of Biopsy Confirmed Acute Rejection at 12 Months.||12 months|||participants|||Number
151499|NCT00374140|Secondary|To Determine Overall Survival, Progression-free Survival, Objective Response Rate, and Toxicities.||Followed until progression and death||||||
151500|NCT00374140|Primary|Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.||Two cycles of treatment with RAD001 (~6 weeks)|||percentage of participants||95% Confidence Interval|Number
151501|NCT00374088|Post-Hoc|Urine Output|Total urine output over the first 24 hours postoperative|24 hours|||mL||Standard Deviation|Mean
151502|NCT00374088|Post-Hoc|Max Creatinine|Maximum serum creatinine over first 3 days postoperative.|72 hours|||mg/dL||Standard Deviation|Mean
151503|NCT00374088|Primary|Maximum Decline in Measured Cardiac Output|Serial cardiac output was measured by thermodilution. The outcome of maximum decline in indexed cardiac output from 1 hour postoperative to lowest output within 24 hours postoperative was then calculated and compared between NAC and placebo groups.|24 hours|Patients in which the surgeon was technically able to place a 4 French thermodilution catheter into the pulmonary artery at the time of surgery had cardiac output measured.||L/min/m2||Standard Deviation|Mean
151504|NCT00373958|Secondary|Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose|Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series and the toddler dose|Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
151505|NCT00373958|Secondary|Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series and one month after toddler dose|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate postinfant series OPA antibody titer to the given serotype.||percentage of participants||95% Confidence Interval|Number
151521|NCT00373685|Other Pre-specified|Percentage of Participants With Positive Blood Fecal Occult|Positive blood fecal occult; blood in feces that is not visibly apparent|Week 24 or ET|ITT||Percentage of participants|||Number
151506|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.||Percentage of participants|||Number
151507|NCT00373958|Primary|Percentage of Participants Reporting Pre-specified Systemic Events|Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after each dose|Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.||Percentage of participants|||Number
151508|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.||IU/mL||95% Confidence Interval|Geometric Mean
151509|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|"Normalization was performed for unit of measure index value as Index Value of 1.00 = 10 mIU/mL."|one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.||index value||95% Confidence Interval|Geometric Mean
151510|NCT00373958|Secondary|Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose||one month after the toddler dose|The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.||µg/mL||95% Confidence Interval|Geometric Mean
151511|NCT00373958|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)||One month after toddler dose (13 to 16 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.(n)=number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.||percentage of participants||95% Confidence Interval|Number
151512|NCT00373958|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).|One Month After the Infant Series (7 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.||Percentage of participants||95% Confidence Interval|Number
151513|NCT00373958|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|1 Month After the Toddler Dose|Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
151514|NCT00373958|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-dose infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
151515|NCT00373698|Secondary|SF-36 Physical Component||3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
151516|NCT00373698|Secondary|SF-36 Mental Component||3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
151517|NCT00373698|Secondary|Depression|Measure using the Hopkins Symptom Checklist-20|3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
151518|NCT00373698|Primary|PTSD Symptom Severity|PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)|3 and 6 months after initial assessment|||units on a scale||Standard Deviation|Mean
151519|NCT00373685|Other Pre-specified|Percentage of Participants With Non-study Medication Utilization|Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.|Baseline through week 24 or ET|ITT; N= number of evaluable participants analyzed||Percentage of participants|||Number
157110|NCT00318591|Secondary|Patient or Caregiver's Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|ITT population||scores on a scale||Standard Deviation|Mean
151522|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
151523|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
151524|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief|Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n= number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
151525|NCT00373685|Secondary|Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall|Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at specific time point; LOCF||Percentage of participants|||Number
151526|NCT00373685|Secondary|Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline|Clinically significant decrease in Hct (greater than or equal to 10 percent [≥10%]) and/or decrease in Hb (≥ 2 g/dL).|Baseline, Weeks 8, 16, 24 or ET|ITT; N=number of evaluable participants analyzed; n=number of evaluable participants analyzed at the specific time point; LOCF||Percentage of participants|||Number
151527|NCT00373685|Secondary|Change From Baseline Hct at Week 24||Week 24 or ET|ITT; N= number of evaluable participants analyzed; LOCF||Percent||Standard Error|Least Squares Mean
151528|NCT00373685|Secondary|Hematocrit (Hct) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed||Percent||Standard Deviation|Mean
151529|NCT00373685|Secondary|Change From Baseline Hb at Week 24||Baseline and Week 24 or ET|ITT; N=number of evaluable participants analyzed; Last observation carried forward (LOCF)||g/dL||Standard Error|Least Squares Mean
151530|NCT00373685|Secondary|Hemoglobin (Hb) at Baseline||Baseline|ITT; N= number of evaluable participants analyzed||gram per deciliter (g/dL)||Standard Deviation|Mean
151531|NCT00373685|Secondary|Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)|GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions|Baseline through week 24 or ET|ITT||Percentage of participants|||Number
151532|NCT00373685|Secondary|Percentage of Participants With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to “Gastrointestinal Signs and Symptoms; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants’ usual function and severe indicated the GI AE interfered significantly with participants’ usual function."|Baseline through week 24 or ET|ITT;||Percentage of participants|||Number
151533|NCT00373685|Primary|Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.|Baseline through week 24 or Early Termination (ET)|Intent-to-Treat (ITT) Population: randomized participants||Percentage of participants|||Number
151534|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a scale||Standard Deviation|Mean
151535|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm|"EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a scale||Standard Deviation|Mean
151536|NCT00372567|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm|EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a Scale||Standard Deviation|Mean
151574|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||number of times per day||Standard Deviation|Mean
151537|NCT00372567|Secondary|Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state."|Days 1 and 28 of each cycle|ITT; Number of participants analyzed: participants who completed the scale; n: participants who completed the scale at the respective cycle.||Scores on a scale||Standard Deviation|Mean
151538|NCT00372567|Secondary|Number of Participants With Pain Progression|Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.||Participants|||Number
151539|NCT00372567|Secondary|Number of Participants With Pain Relief Response|Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline.||Participants|||Number
151540|NCT00372567|Secondary|Time to Pain Progression (TTPP)|TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an event.||Days||95% Confidence Interval|Median
151541|NCT00372567|Secondary|Duration of Response (DR)|"Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.~Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions."|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study.||Weeks||Full Range|Median
151542|NCT00372567|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT||Weeks||95% Confidence Interval|Median
151543|NCT00372567|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 up to 26|ITT||Participants|||Number
151544|NCT00372567|Secondary|Time to Treatment Failure (TTF)|TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.|Day 28 of Cycle 1 up to 26|ITT; Number of participants analyzed: participants with treatment failure.||Months||95% Confidence Interval|Median
151545|NCT00372567|Secondary|Time to Pain Relief Response (TTPR)|Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.|Day 28 of Cycle 1 up to 26|ITT||Days||95% Confidence Interval|Median
151546|NCT00372567|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.|Baseline up to 2 years|ITT||Months||95% Confidence Interval|Median
151547|NCT00372567|Primary|Progression-Free Survival (PFS)|Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.|Baseline, Week 5, and every 8 weeks until Year 2|Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death).||Months||95% Confidence Interval|Median
151548|NCT00372528|Secondary|Mean Number of Seizures|Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.|Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)|SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit.||Seizures||Standard Deviation|Mean
151575|NCT00373360|Secondary|Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||number of times per day||Standard Deviation|Mean
151549|NCT00372528|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Year 5 and follow-up (30 days after last dose)|Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.||Participants|||Number
151550|NCT00373529|Other Pre-specified|Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors|The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.|approximately Month 2|Full analysis set (FAS) of participants who achieved remission and had baseline prognostic factor||participants|||Number
151551|NCT00373529|Secondary|Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)|Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.|up to Day 30|Full analysis set||percentage of participants|||Number
151552|NCT00373529|Secondary|Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods|"Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline.~NCI Common Terminology Criteria for Severity:~Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE"|Up to 2 years|Full analysis set||participants|||Number
151553|NCT00373529|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.|Up to 2 years|Full analysis set||weeks||95% Confidence Interval|Median
151554|NCT00373529|Secondary|Kaplan Meier Estimate for Disease-free Survival (DFS)|DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.||weeks||95% Confidence Interval|Median
151555|NCT00373529|Secondary|Kaplan Meier Estimate for Duration of Remission (DOR)|DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day. Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.|Up to 2 years|Full analysis set (FAS) of participants who achieved remission.||weeks||95% Confidence Interval|Median
151556|NCT00373529|Primary|Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)|Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.|approximately Month 2|Full analysis set (FAS)||percentage of participants|||Number
151557|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 21 (400 mg)||Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.||μM||Standard Deviation|Geometric Mean
151558|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 3 (600 mg)||Day 3 (600 mg)|||μM||Standard Deviation|Geometric Mean
151559|NCT00373490|Secondary|Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)||Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.||μM||Standard Deviation|Geometric Mean
151560|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 24) plus AUC (24 - ∞)|Day 21 (400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, four (4) participants had missing Pharmacokinetics Data on Day 21 because they did not receive study drug on day 21.||μM·hr||Standard Deviation|Geometric Mean
151561|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to 24 ｈours. It is obtained from AUC (0 - 12) plus AUC (12 - ∞)|Day 3 (600 mg)|||μM·hr||Standard Deviation|Geometric Mean
151562|NCT00373490|Secondary|Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)|Area Under Curve (AUC(0-infinity))=Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (o- ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). At 600 mg, t=12 hours and at 400 mg, t=24 hours.|Day 1 (600 mg and 400 mg)|Six (6) participants received vorinostat at 400 mg once daily. Of these, one (1) participant had missing Pharmacokinetics Data on Day 1 because the participant vomited after administration on Day 1.||μM·hr||Standard Deviation|Geometric Mean
151563|NCT00373490|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment|21 Days (first cycle)|Six (6) participants received vorinostat at 400 mg once daily. Of these, 2 participants did not complete the first cycle resulting in the drug compliance falling below 75%, and thus these participants were excluded from the DLT assessment.||Participants|||Number
151564|NCT00373425|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.~An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.~A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.|Randomized Cohort, safety analysis set: all randomized participants who received at least one dose of study drug. One participant in the Randomized Cohort assigned to the erlotinib arm received placebo instead due to a dispensing error and is included in the placebo group for safety analyses.||participants|||Number
151565|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)|Randomized cohort full analysis participants who were EGFR mutation positive||months||95% Confidence Interval|Median
151566|NCT00373425|Secondary|Overall Survival in Participants With EGFR Mutation - Positive Tumors|"Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.~Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected."|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)|Randomized cohort full analysis participants who were EGFR mutation positive||months||95% Confidence Interval|Median
151567|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set (all randomized participants).||months||95% Confidence Interval|Median
151568|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set participants who are EGFR mutation positive||months||95% Confidence Interval|Median
151569|NCT00373425|Secondary|Disease-free Survival in Participants With EGFR Mutation - Positive Tumors|Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set participants who are EGFR mutation positive||months||95% Confidence Interval|Median
151570|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).|Randomized cohort full analysis set||months||95% Confidence Interval|Median
151571|NCT00373425|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set||months||95% Confidence Interval|Median
151572|NCT00373425|Primary|Disease Free Survival (DFS)|DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.|Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).|Randomized cohort full analysis set (all randomized participants).||months||95% Confidence Interval|Median
151573|NCT00373360|Secondary|Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol||Baseline and Week 8|||number of times per day||Standard Deviation|Mean
151583|NCT00373360|Secondary|Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
151584|NCT00373360|Secondary|Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
151585|NCT00373360|Secondary|Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
151586|NCT00373360|Secondary|Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
151587|NCT00373360|Secondary|Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment.|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
151588|NCT00373360|Secondary|Change in Symptoms of Chest Pain From Baseline to Week 8|The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
151589|NCT00373360|Secondary|Change in Symptoms of Syncope From Baseline to Week 8|The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
151590|NCT00373360|Secondary|Change in Symptoms of Fatigue From Baseline to Week 8|The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
151591|NCT00373360|Secondary|Change in Symptoms of Dizziness From Baseline to Week 8|The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
151592|NCT00373360|Secondary|Change in Symptoms of Orthopnea From Baseline to Week 8|The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
151593|NCT00373360|Secondary|Change in Symptoms of Edema From Baseline to Week 8|The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.|Baseline to Week 8|||percentage of participants|||Number
151594|NCT00373360|Secondary|Change in Symptoms of Dyspnea From Baseline to Week 8|The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.|Baseline and Week 8|||percentage of participants|||Number
151595|NCT00373360|Secondary|Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 8|||percentage of participants|||Number
151596|NCT00373360|Secondary|Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 8|||units on a scale||Standard Deviation|Mean
151597|NCT00373360|Primary|Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.||Baseline and Week 8|"As this was a small open label study, the statistics applied to the results were descriptive. For all efficacy endpoints, data obtained from study assessments during the treatment phase were compared to Baseline.~assessments"||meters||Standard Deviation|Mean
151599|NCT00373334|Secondary|Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief|Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.|8 weeks|The analysis population includes all patients that took drug and reached the 8 week study timepoint.||participants|||Number
151600|NCT00373334|Primary|Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success|The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.|8 weeks|The analysis population includes all patients that took drug and had any efficacy data reported. 5 patients that were lost to follow up (1 nizatidine 2.5 group, 1 nizatidine 5.0 group, 3 placebo group) were not included because they had no efficacy data and had not reported any adverse events.||participants|||Number
151601|NCT00373269|Secondary|TF-PCA|TF-PCA levels compared between normoglycemic and hyperglycemic subjects.|Baseline|||U/ml||Standard Deviation|Mean
151602|NCT00373269|Primary|FVIIa|FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.|Baseline|||mU/ml||Standard Deviation|Mean
151603|NCT00373256|Secondary|Biomarkers|Concentrations of plasma proteins (eg, soluble Vascular Endothelial Growth Factor Receptor 2 [VEGFR2] and VEGFR3, VEGF-A, placental growth factor [PlGF], soluble KIT, and possibly soluble PDGFRβ and PDGF) that may be associated with angiogenesis and tumor proliferation.|Day 1 of Cycles 1 through 3 and 5, Day 8 of Cycle 1, and Day 15 of Cycle 1|ITT. Biomarker data were collected, but since the study was stopped early and there were too few events of OS, PFS, etc, data were not analyzed.|||||
151604|NCT00373256|Secondary|EQ - Visual Analog Scale (EQ-VAS)|EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-VAS evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.|||||
151605|NCT00373256|Secondary|Euro Quality of Life-5 Dimension (EQ-5D)|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the subject.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EQ-5D evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.|||||
151606|NCT00373256|Secondary|EORTC QLQ Breast Cancer Module (BR23)|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. BR23 evaluations were not analyzed since enrollment in this study was terminated early for futility at the first interim analysis.|||||
151607|NCT00373256|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1 of Cycles 1 through 7 and then odd-numbered cycles thereafter until 18 months|ITT. EORTC QLQ-C30 evaluations were not analyzed since enrollment in this study was terminated early for futility.|||||
151608|NCT00373256|Secondary|Percentage of Participants Surviving at 1 and 2 Years|Percentage of those surviving at the end of one year or end of 2 years from the first dose of study treatment.|Year 1, Year 2|ITT.||percentage of participants|||Number
151609|NCT00373256|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. OS (in months) was calculated as (date of death minus randomization date +1) divided by 30.4.|From date of randomization up to 5 years. Survival follow-up changed to 28-days after treatment discontinuation when study was discontinued.|ITT. The median OS for bevacizumab + paclitaxel at the time of data cut off was not reached; therefore, it could not be calculated.||Months||95% Confidence Interval|Median
151610|NCT00373256|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. DR was calculated as [the date response ended (ie, date of progressive disease or death) minus first CR or PR date that was subsequently confirmed +1)] divided by 30.4.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death due to any cause|ITT. DR was calculated for the subgroup of subjects with objective response. 78 subjects reported CR or PR response and were analyzed for DR in each treatment group.||Months||95% Confidence Interval|Median
151611|NCT00373256|Secondary|Number of Participants With Objective Response|Objective response = participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months|ITT||participants|||Number
151612|NCT00373256|Primary|Progression-Free Survival (PFS)|Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4|From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death|The intent-to-treat (ITT) population included all patients who were randomized.||Months||95% Confidence Interval|Median
151613|NCT00373113|Secondary|EORTC QLQ Breast Cancer Module (BR23)|"BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.~Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ Cancer Module (BR23) analysis was not performed.||scores on a scale||Standard Deviation|Mean
151614|NCT00373113|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|"EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).~Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms."|From Day 1 of Cycle 1, then odd numbered cycles thereafter|The study was stopped early for futility and EORTC QLQ-C30 analysis was not performed.||scores on a scale||Standard Deviation|Mean
151615|NCT00373113|Secondary|Overall Survival (OS)|Average time from randomization to first documentation of death due to any cause.|From time of randomization until death|ITT population||Months||95% Confidence Interval|Median
151616|NCT00373113|Secondary|Time to Tumor Response (TTR)|Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|The study was stopped early for futility and TTR analysis was not performed.||Months||95% Confidence Interval|Median
151617|NCT00373113|Secondary|Duration of Response (DR)|Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months or death|ITT population. DR was calculated for the subgroup of participants with objective response. 27 participants in the sunitinib arm and 40 participants in the capecitabine arm reported CR or PR response and were analyzed for DR.||Months||95% Confidence Interval|Median
151618|NCT00373113|Secondary|Number of Participants With Overall Response (OR)|OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population||Participants|||Number
151619|NCT00373113|Secondary|Time to Tumor Progression (TTP)|Time from randomization to first documentation of objective tumor progression.|From time of randomization to every 6 weeks thereafter through 22 months|ITT population||Months||95% Confidence Interval|Median
151620|NCT00373113|Primary|Progression-Free Survival (PFS)|Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.|From time of randomization to every 6 weeks thereafter through 22 months or until death|Intent-to-treat (ITT) population: included all participants who were randomized.||Months||95% Confidence Interval|Median
151621|NCT00372996|Secondary|EORTC QLQ Breast Cancer Module (BR23) Scores|EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 â€˜Not at Allâ€™ to 4 â€˜Very Muchâ€™). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.|Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
151622|NCT00372996|Secondary|European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months|The study was terminated early secondary to strategic reasons and the questionnaires were discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
151623|NCT00372996|Secondary|Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway||Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
151624|NCT00372996|Secondary|Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)||Predose on Day 1 of Cycle 1|The study was terminated early due to strategic reasons and biomarker sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
158793|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Maintenance|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
151625|NCT00372996|Secondary|Number of Participants With Negative Human Anti-Human Antibodies (HAHAs)|Negative human anti-human antibodies were defined as <6.64|Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion|All randomized participants who started treatment and who had at least 1 sample submitted for the biomarker; collection of samples for this analysis was stopped after Amendment 6. All samples were negative to HAHA.||participants|Participants||Number
151626|NCT00372996|Secondary|Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
151627|NCT00372996|Secondary|Minimum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and PK sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
151628|NCT00372996|Secondary|Maximum Plasma Concentration of CP-751,871||Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871|The study was terminated early due to strategic reasons and pharmacokinetic (PK) sampling was discontinued by Protocol Amendment 6. Therefore, the analysis was not performed and an incomplete data set was not reported because it would potentially skew the data, and is not statistically relevant, thus could be misleading.|||||
151629|NCT00372996|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months|Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS||percentage of participants||95% Confidence Interval|Number
151630|NCT00372996|Primary|PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|FAS; only participants with baseline HbA1c <5.7% were included in the analysis.||months||95% Confidence Interval|Median
151631|NCT00372996|Primary|Progression-Free Survival (PFS)|PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent [%] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors [RECIST]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.|Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months|Full Analysis Set (FAS): all enrolled participants; grouped by randomized arm, where the first 10 participants enrolled but not randomly assigned to treatment were not included.||months||95% Confidence Interval|Median
151632|NCT00372970|Primary|Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.|"Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI).~The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be >=27. In a previous study internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores."|1 month|All patients had gastroparesis and underwent EGD. Injection double blinded.||units on a scale||Standard Deviation|Mean
151633|NCT00372775|Secondary|PFS in Subgroups Defined by RNA Expression Profiles of Tumors|PFS defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was to be determined in subgroups defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT3, KIT, and RET) level (low/high relative to expression of Glyceraldehyde-3-Phosphate Dehydrogenase [GAPDH] reference gene). PFS calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.||weeks||90% Confidence Interval|Median
158794|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Firmness|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
151634|NCT00372775|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Tumor samples were not anonymized. RNA expression profile was to include colony-stimulating factor 1 receptor (CSF-1R), platelet-derived growth factor receptor alpha and beta (PDGFRalpha and PDGFRbeta), vascular endothelial growth factor (VEGF), VEGF-C, VEGF receptor 1, 2, and 3 (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor (FGF), FMS-like tyrosine kinase 3 (FLT3), KIT (stem cell factor receptor), and RET (rearranged during transfection).|Day 1 of Week 1 and every 4 weeks up to 1 year|ITT. Only 4 RNA samples were collected and no statistical analyses performed.||Percentage of participants|||Number
151635|NCT00372775|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts|A blood sample (6mL) collected before treatment with Sunitinib and used to isolate deoxyribonucleic acid (DNA). These samples were not anonymized.|Day 1 prior to dosing|ITT. c-Kit, Flt-3 and c-Fms with blood count samples collected; however, no statistical analyses performed since power was insufficient.||picograms per milliliter (pg/mL)|||Number
151636|NCT00372775|Secondary|Ctrough of Sunitinib Metabolite (SU012662)|A single blood sample (4 mL) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.||ng/mL||Standard Deviation|Mean
151637|NCT00372775|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|A single blood sample (4 milliliters [mL]) collected pre-dose on Day 1 of Cycles 2, 3, and 4 to determine Ctrough of Sunitinib and its metabolite SU12662. Each cycle = 28 days. Ctrough defined as plasma concentration prior to study drug administration. Trough plasma concentrations were dose-corrected.|Day 1 of Week 5, 9, and 13|ITT participants who had pharmacokinetic results for at least 1 day. Ctrough only calculated for subgroup of participants with observations (non-missing concentrations). n = number of participants with evaluable data.||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
151638|NCT00372775|Secondary|Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score|Change from baseline in FBrSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 60. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data||Scores on a scale||95% Confidence Interval|Mean
151639|NCT00372775|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score|Change from baseline in FLSI Score was calculated Day 1 of Cycle 2 to 13. Each cycle = 28 days. Scores ranged from 0 to 24. Higher scores indicated better outcomes.|Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)|ITT population of participants with post baseline patient-reported outcome data||Scores on a scale||95% Confidence Interval|Mean
151640|NCT00372775|Secondary|Number of Deaths Due to Intracranial Versus Systemic Progression|Number of deaths determined to be intracranial versus systemic progression, according to investigators’assessment.|Baseline until death (up to 1 year)|ITT||Participants|||Number
151641|NCT00372775|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of those surviving at end of 1 year from the first dose of study treatment.|Year 1|ITT||Percentage of participants|||Number
151642|NCT00372775|Secondary|Overall Survival (OS)|OS calculated as: (date of death minus date of first dose plus 1)divided by 30.4.|Baseline until death (up to 1 year)|ITT. In the absence of confirmation of death, survival time was censored to last date of known contact.||Months||95% Confidence Interval|Median
151643|NCT00372775|Secondary|Duration of Response (DR)|DR defined as difference in weeks between first date criteria for progression occurred, or participant died due to any cause and first date that criteria for a PR or CR were met and subsequently confirmed ≥4 weeks later. Since day criteria for PR or CR were met and first day criteria for progression occurred (or participant died) were each counted as a full day, 1 day was added to each calculation. DR (in weeks) calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|Day 7 of Week 4 and every 4 weeks up to 1 year|ITT. DR only calculated for the subgroup of participants with an objective tumor response.||Weeks|||Number
151644|NCT00372775|Secondary|Number of Participants With Intracranial Objective Disease Response|Intracranial objective disease response defined as participants with confirmed CR or PR, according to WHO criteria. CR defined as disappearance of all enhancing tumor. PR defined as a ≥50% reduction from baseline in sum of the products of all enhancing tumors.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable intracranial disease at baseline.||Participants|||Number
151645|NCT00372775|Secondary|Time to Objective Intracranial Progression|Time in weeks from start of study treatment to first documentation of objective intracranial tumor progression. Intracranial tumor progression defined as ≥25% increase from smallest size in sum of products of all enhancing tumors or appearance of any new tumor, according to World Health Organization (WHO) criteria. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day added to each calculation. Time to Objective Intracranial Progression = (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)|ITT||Weeks||95% Confidence Interval|Median
151646|NCT00372775|Secondary|Number of Participants With Objective Disease Response|Objective disease response defined as participants with confirmed complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49|ITT with measurable disease at baseline.||Participants|||Number
151647|NCT00372775|Secondary|Time to Neurological Progression (TNP)|Time in weeks between first date criteria for focal neurological deficit were met and date of first dose of medication. Criteria for focal neurological deficit included speech or language difficulties, vision changes, loss of coordination or fine motor control, and seizures. Since day of first dose of medication and day criteria for focal neurological deficit were met were each counted as a full day, 1 day was added to each calculation. TNP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 28 to focal neurological deficit (up to 1 year)|ITT||Weeks||Full Range|Median
151648|NCT00372775|Secondary|Time to Tumor Progression (TTP)|Time from start of study treatment to first documentation of objective tumor progression. Tumor progression defined as greater than or equal to 20 percent (≥20%) increase in sum of longest dimensions of target lesions using as reference smallest sum of longest dimensions recorded since treatment started, or unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST). TTP = (first event date minus date of first dose of study medication plus 1) divided by 7.02.|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)|ITT||Weeks||95% Confidence Interval|Median
151649|NCT00372775|Primary|Progression-Free Survival (PFS)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)|Intent-to-treat (ITT): all participants enrolled in the study who received at least 1 dose of study medication.||Weeks||90% Confidence Interval|Median
151650|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Psychological Scale Score at End of Study (Week 24)|The AcroQoL contains 14 items on Psychological aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the psychological scale ranges from 14-70. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.||Percent of maximum score||Standard Deviation|Mean
151651|NCT00372697|Secondary|Acromegaly Quality of Life (AcroQoL) Questionnaire Physical Scale Score at End of Study (Week 24)|The AcroQoL contains 8 items on Physical aspects. Participants were asked to rate each item on a 1-5 Likert scale measuring either the frequency of occurrence (always, most of the time, sometimes, rarely, or never) or the degree of agreement (completely agree, moderately agree, neither agree nor disagree, moderately disagree, completely disagree). The score on the physical scale can range from 8-40. A higher score indicates better Quality of Life.|End of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.||Percent of maximum score||Standard Deviation|Mean
151652|NCT00372697|Secondary|Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)|The investigator asked the participant to score the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0=absent; 1=mild; 2=moderate; 3=severe, but not disabling; 4=severe and disabling). The percentage of asymptomatic participants, ie, with a score of 0 for all symptoms, was calculated.|Week 12 and end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication.||Percentage of participants|||Number
151653|NCT00372697|Secondary|Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.||Percentage of participants|||Number
151654|NCT00372697|Secondary|Change in Tumor Volume From Screening to End of Study (Week 24)|A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm^3) was calculated from measurements obtained in 3 axes from the MRI images.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of assigned study medication and who had data for this outcome measure.||mm^3||Standard Deviation|Mean
151655|NCT00372697|Primary|Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)|Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.||µg/L||Standard Deviation|Mean
151656|NCT00372697|Primary|Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)|Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.|Screening to end of study (Week 24)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and who had at least one post-baseline evaluation of the primary variable.||µg/L||Standard Deviation|Mean
151657|NCT00372619|Secondary|Correlate the Expression of Apoptosis Specific Genes|Correlate the expression of apoptosis specific genes with chemoresistance and determine whether therapy with clofarabine is able to overcome blocks in apoptosis through modulation of gene expression. Gene expression analysis will be performed on specimens obtained during therapy. Apoptosis specific microarray data will be analyzed using GeneTraffic software (Iobion Informatics, La Jolla CA).|End of therapy||||||
151658|NCT00372619|Secondary|Safety and Tolerability as Measured by CTCAE v3.0||End of therapy||||||
151685|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
151659|NCT00372619|Primary|Overall Response (CR for ALL Patients), (CR + CRp for AML Patients)|"Overall response for ALL patients: CR - complete remission (attainment of an M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil count (ANC) > 750/μL and platelet count > 75,000/μL).~Overall response for AML patients: (CR + CRp), defined as:~CR - complete remission (attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (absolute neutrophil count (ANC) > 1000/uL and platelet count > 100,000/uL)) or CRp - remission without platelet recovery (Attainment of an M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of absolute neutrophil count (ANC) > 1000/uL and platelet transfusion independence (defined as: no platelet transfusions x 1 week))."|2 cycles or up to 84 days|||participants|||Number
151660|NCT00372593|Secondary|Toxicities, Including Infectious Complications||From the time therapy is initiated, assessed up to 10 years||||||
151661|NCT00372593|Secondary|Time to Marrow Recovery||At 25 days after treatment with Induction I, Induction II, and Intensification I||||||
151662|NCT00372593|Secondary|Mortality||During the first three courses of therapy||||||
151663|NCT00372593|Secondary|Disease-free Survival|The Kaplan-Meier method will be used to calculate estimates disease free survival (DFS). Analysis of DFS of Down syndrome patients will be performed separately.|Time from the end of course 3 (Intensification I) to death or relapse; assessed for up to 10 years||||||
151664|NCT00372593|Secondary|Remission Induction Rate After 2 Courses of Induction Therapy|Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.|After 2 courses of induction (I and II) therapy, assessed for up to 10 years||||||
151665|NCT00372593|Primary|Overall Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.||percentage of participants||95% Confidence Interval|Number
151666|NCT00372593|Primary|Event-free Survival at 3 Years|The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt^2 (truncated at 3 standard deviations) and 2.5% type I error.|Time from study entry to time of induction failure, relapse, or death, assessed at 3 years|Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.||percentage of participants||95% Confidence Interval|Number
151667|NCT00372489|Primary|Proportion of Participants With Mean Hemoglobin in the Target Range of 10.0-12.0 Grams Per Deciliter (g/dL) After Dosing Guideline Change||Up to 54 months|Full Analysis - Number of participants with hemoglobin assessed after dosing guideline change||percentage of participants|||Number
151668|NCT00372424|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Paclitaxel||End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|Data not analyzed since paclitaxel was not administered in the study.|||||
151669|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of Trastuzumab|Ctrough = the concentration prior to study medication administration.|Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6|Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.|||||
151670|NCT00372424|Secondary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel|Concentration values below the lower limit of quantification were taken as zero.|End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6|PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.||ng/mL||Standard Deviation|Mean
151671|NCT00372424|Secondary|Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)|Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.|Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1|Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
151672|NCT00372424|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).||weeks||95% Confidence Interval|Median
151673|NCT00372424|Secondary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Study population included all participants who received at least 1 dose of study medication.||weeks||95% Confidence Interval|Median
151674|NCT00372424|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)|Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.||percentage of participants||95% Confidence Interval|Number
151675|NCT00372424|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From screening until 28 days post last dose of study drug|Safety population included all participants enrolled in the study who received at least 1 dose of study medication.||participants|||Number
151676|NCT00372411|Secondary|Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline|The Modified Ashworth Scale for spasticity is a measurement of spasticity across 9 muscle groups. Each muscle group is scored on a 0 to 5 scale with higher scores indicating worse functioning. The total score is the average score from the 9 muscle groups and ranges from 0 to 5 with higher scores indicating worse functioning.|12 weeks minus baseline|||units on a scale||Standard Error|Least Squares Mean
151677|NCT00372411|Secondary|Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline|The Numeric Rating Scale (NRS) for pain is a self report scale ranging from 0 (no Pain) to 10 (pain as bad as you can imagine).|12 weeks minus baseline|||units on a scale||Standard Error|Least Squares Mean
151678|NCT00372411|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is a functionally-based test designed to provide an objective measure of both proximal (during tasks such as lifting the hand from table to box top) and distal control (grasping pencil, bringing soda can to mouth) of the paretic arm for patients after stroke or traumatic brain injury. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds, with higher scores indicating worse functioning. Outcome measure is the change in the Wolf score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|||Seconds||Standard Error|Least Squares Mean
151679|NCT00372411|Secondary|Stroke Impact Scale|The Stroke Impact Scale (SIS) is stroke specific, self-reported measure that evaluates function and quality of life in eight clinically relevant domains. The domains of hand function, activities of daily living, instrumental activities of daily living, mobility, and social participation were used; total score ranges from 0 to 100 with higher values indicating better functioning. Outcome is change at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|||units on a scale||Standard Error|Least Squares Mean
151680|NCT00372411|Primary|Fugl-Meyer Assessment for Motor Recovery (FM) Scale|Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.|6, 12, 24 and 36 weeks minus baseline|All participants with baseline and follow-up measures were included by intention-to-treat||units on a scale||Standard Error|Least Squares Mean
151681|NCT00372385|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
151682|NCT00372385|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
151683|NCT00372385|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||participants|||Number
151684|NCT00372385|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|Completion of study drug dosing (up to Week 48)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
151686|NCT00372385|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
151687|NCT00372060|Other Pre-specified|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52|Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.|Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group.|The Completers Population (CP) includes all randomized patients who took at least 1 dose of sitagliptin and had [1] a baseline (Sitagliptin/Sitagliptin group) or Week 12 (Placebo/Sitagliptin group) value and [2] a value at Week 52.||Percent||95% Confidence Interval|Mean
151688|NCT00372060|Other Pre-specified|Change From Baseline in 2 Hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 weeks|Analysis in the Full Analysis Set without Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline values.).||mg/dL||95% Confidence Interval|Least Squares Mean
151689|NCT00372060|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)||mg/dL||95% Confidence Interval|Least Squares Mean
151690|NCT00372060|Primary|Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12|Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.|12 Weeks|Analysis in the Full Analysis Set with Last Observation Carried Forward (The Full Analysis Set population includes all randomized patients who took at least 1 dose of study medication and had both a baseline and at least one post-baseline value.)||Percent||95% Confidence Interval|Least Squares Mean
151691|NCT00371865|Secondary|Pain Anxiety Symptom Scale - 20|This questionnaire measures pain-related anxiety. Scores range from 0 to 100, with higher scores indicating higher levels of anxiety.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
151692|NCT00371865|Secondary|Beck Depression Inventory|This questionnaire measures depressive symptoms. Scores range from 0 to 63, with higher scores indicating higher levels of depressive symptoms.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
151693|NCT00371865|Secondary|SF-12|This questionnaire measures quality of life. Scores range from 0 to 100, with higher scores indicating better quality of life.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
151694|NCT00371865|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|This questionnaire measures levels of activity that can be affected by pain. Full measure has a range of 0-6, with higher scores indicating higher levels of activity.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
151695|NCT00371865|Primary|Brief Pain Inventory|This questionnaire measures pain severity and interference. Scores range from 0-10, with higher scores indicating more pain.|12 weeks (post treatment)|||units on a scale||Standard Deviation|Mean
151696|NCT00371839|Primary|Ability to Understand Speech in Noise Background|Measure speech perception for sentences in background noise|one year|||Percent correct of 100 presented words||Standard Deviation|Mean
151697|NCT00371826|Secondary|Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)|Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.|Week 2, Month 24|Safety population extension (SAF-EX): All patients who entered the extension period, who were treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with week 2 and month 24 assessment for this analysis were included.||g/cm^2||Standard Deviation|Mean
151698|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
151699|NCT00371826|Secondary|Number of Patient Survival and Graft Survival (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151700|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication||Participants|||Number
151721|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on Proteinuria were included in this analysis.||mg/mg||Standard Deviation|Mean
151701|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)|The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151702|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)||At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
151703|NCT00371826|Secondary|Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151704|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall Post Baseline up to month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with serum lipid assessment anytime post baseline up to 36 month were included .||Participants|||Number
151705|NCT00371826|Secondary|Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L~Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L"|Overall post baseline up to month 12|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with serum lipid assessment anytime post baseline up to 12 month were included in this analysis.||Participants|||Number
151706|NCT00371826|Secondary|Number of Participants With Any Wound Problems (36 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.||Participants|||Number
151707|NCT00371826|Secondary|Number of Participants With Wound Problems(12 Months Analysis)|Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151708|NCT00371826|Secondary|Number of Participants With Employment Status (36 Months Analysis)|"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other"|At screening (at day 0 +/- 7 days ), At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
151709|NCT00371826|Secondary|Number of Participants With Employment Status (12 Months Analysis)|"The various employment status reported are:~Employed/self employed full time~Employed part time~Unemployed~Homemaker~Volunteer~Permanently disabled~Non-permanently disable~Retired~Other"|At screening (at day 0 +/- 7 days ), At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151710|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.||Participants|||Number
151711|NCT00371826|Secondary|Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)|This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151761|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
151712|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 24|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug. Patients with completed SF-36 assessment were included in this analysis.||units on a scale||Standard Deviation|Mean
151713|NCT00371826|Secondary|Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)|"SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).~Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Only those patients who had completed the QoL assessment for Month 12 were included in this analysis.||units on a scale||Standard Deviation|Mean
151714|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (36 Months Analysis)||Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.||participants|||Number
151715|NCT00371826|Secondary|Number of Participants With Erythropoietin Usage (12 Months Analysis)||Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||participants|||Number
151716|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post baseline up to Month 36|Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with baseline and overall post baseline up to month 36 assessment were included.||Participants|||Number
151717|NCT00371826|Secondary|Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)|"Notable abnormal systolic blood pressure is defined as :~Either an increase of >=30 that results in >=180 or >200 (mm/Hg)~OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline~Notable abnormal diastolic blood pressure is defined as :~Either an increase of >=20 that results in >=105 or >115 (mm/Hg)~OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline"|Baseline, Overall post-baseline up to 12 month|Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with baseline and overall post baseline up to 12 month assessment for this analysis were included.||Participants|||Number
151718|NCT00371826|Secondary|Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)|"The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL~Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.||Participants|||Number
151719|NCT00371826|Secondary|Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)|"The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:~Patients receiving glucose lowering treatment~Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions~Hemoglobin subtype A1c (HbA1c) > 6.5%~Diabetes reported as treatment emergent AE with end date > Day 15"|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on PTDM were included in this analysis.||Participants|||Number
151720|NCT00371826|Secondary|Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)|Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.|At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment in extension period. This also includes all patients who were randomized but were not treated with study medication. Patients with ACR data at particular time point were included for analysis.||mg/mmol||Standard Deviation|Mean
151848|NCT00371267|Secondary|Beck Depression Inventory (BDI)-2 Total Score|Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
151722|NCT00371826|Secondary|Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine clearance were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.||mL/min||Standard Deviation|Mean
151723|NCT00371826|Secondary|Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)|"Creatinine clearance were calculated according to the Cockcroft-Gault formula:~CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].~The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on creatinine clearance were included in this analysis.||mL/min||Standard Deviation|Mean
151724|NCT00371826|Secondary|Mean Serum Creatinine (36 Months Analysis)||At Month 12, 18, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine serum creatinine were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.||umol/L||Standard Deviation|Mean
151725|NCT00371826|Secondary|Mean Serum Creatinine (12 Months Analysis)||At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on serum creatinine were included in this analysis.||umol/L||Standard Deviation|Mean
151726|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with transmural arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.||Participants|||Number
151727|NCT00371826|Secondary|Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)|"Based on Banff 97 criteria, sub clinical acute rejection can be:~GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).~GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).~GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).~GRADE III - Cases with “transmural” arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).~Borderline category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section)."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.||Participants|||Number
151728|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)|"Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data available at month 36 were included in this analysis.||Participants|||Number
151729|NCT00371826|Secondary|Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)|"A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.~Data summarized by 3 categories. Yes - Patients with histological evidence of CAN ; No - Patients with histological evidence of CAN and Not Done - Central protocol defined kidney allograft biopsies were not done."|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.||Participants|||Number
151849|NCT00371267|Primary|Short Form-12 Physical Health|Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
151730|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
151731|NCT00371826|Secondary|Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)|"Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.~The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss."|Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151732|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12, 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.||Participants|||Number
151733|NCT00371826|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)|A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.|At Month 12|Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.||Participants|||Number
151734|NCT00371826|Secondary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 24 and 36|Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Missing values were imputed by last observation carried forward (LOCF) using values beyond Month 6||mL/min per 1.73 m^2||Standard Error|Mean
151735|NCT00371826|Primary|Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)|The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.|At Month 12|Modified intent-to-treat (mITT)-Add population: All ITT patients who had a calculated GFR value recorded at Month 12 post-randomization including those collected after discontinuation of study medication and retrospectively collected creatinine and urea data||mL/min per 1.73 m^2||Standard Deviation|Mean
151736|NCT00371787|Primary|Neovascularization|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|9 month|||mm||Standard Deviation|Mean
151737|NCT00371787|Primary|Neovascularisation|length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.|baseline|||mm||Standard Deviation|Mean
151738|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|9 month|||logMAR||Standard Deviation|Mean
151739|NCT00371787|Primary|Visual Acuity|level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.|baseline|Per Protocol. Only the data from participants who completed all study visits were analyzed.||logMAR||Standard Deviation|Mean
151740|NCT00371761|Primary|Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response|"Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive.~Virological response was defined as having < 10^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction).~Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L."|At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks]|||Participants|||Number
151741|NCT00371683|Secondary|Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose < LLN then use < 0.8*predose; or > ULN if pre-dose > ULN then use > 2.0*predose or <LLN. Total Protein: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9*predose or > ULN if pre-dose > ULN then use 1.1*predose or < LLN. Uric Acid: > 1.5*ULN, or if pre-dose > ULN then use > 2*predose. Creatine Kinase (CK): > 5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
151850|NCT00371254|Secondary|Number of Participants With Abnormal Vital Signs Measurements|Vital signs included systolic and diastolic blood pressure and heart rate. The investigator used his or her judgement to decide whether or not the values were abnormal.|At each study visit (Week 3, 5, 7, 9, 13, 17 and 25) and end of treatment (up to 17 weeks)|All treated participants||participants|||Number
151742|NCT00371683|Secondary|Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period|Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Calcium: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN If pre-dose > ULN then use > 1.25*predose or < LLN. Chloride: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*predose or > ULN if pre-dose > ULN then use > 1.1*predose or < LLN. Sodium: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*predose or >ULN if pre-dose > ULN then use > 1.05*predose or < LLN. Bicarbonate: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*predose or > ULN if pre-dose > ULN then use > 1.25*predose or < LLN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
151743|NCT00371683|Secondary|Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: > 1.5*ULN. Total bilirubin: : > 2*ULN, Alanine Aminotransferase (ALT) high: > 3*ULN. Alkaline Phosphatase (ALP): > 2*ULN. Aspartate Aminotransferase (AST): > 3*ULN. Creatinine: > 1.5*ULN.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
151744|NCT00371683|Secondary|Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: < 100,000/mm^3 (or < 100*109 cells/L). Erythrocytes low: < 0.75 *pre-dose. Hemoglobin low: > 2 g/dL decrease compared to pre-dose or Value ≤ 8 g/dL. Hematocrit low: < 0.75*pre-dose . Leukocytes: < 0.75*LLN or > 1.25* ULN, or if pre-dose < LLN then use < 0.8*predose or > ULN if pre-dose > ULN then use > 1.2*predose or < LLN. Lymphocytes (absolute): < 0.750*10^3 cells/µL or > 7.50*10^3 cells/ µL. Eosinophils (absolute) high: > 0.750*10^3 cells/µL. Basophils(absolute) high: > 400/mm^3 (or > 0.4*103 cells/µL). Monocytes (absolute) high: > 2000/mm^3 (or > 2*103 cells/µL). Neutrophils(absolute) high: < 1.0*103 cells/µL.|First dose to last dose of study drug (12 days), plus 2 days|All participants who received at least one dose of study drug and had available laboratory results for that analyte and treatment group.||participants|||Number
151745|NCT00371683|Secondary|Mean Change From Baseline in Heart Rate During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had heart rate measurements at baseline were summarized.||bpm||Standard Error|Mean
151746|NCT00371683|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg).|Baseline to last dose of study drug, plus 2 days|All participants who received at least one dose of study drug and had blood pressure measurements at baseline were summarized.||mmHg||Standard Error|Mean
151747|NCT00371683|Secondary|Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)|All participants who received at least 1 dose of study drug during the Treatment Period.||participants|||Number
151748|NCT00371683|Secondary|Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period|A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients.|Post last dose of study drug to Day 72 (60 days)|Participants who received at least one dose of study drug and entered the Follow-Up period||percentage of participants||95% Confidence Interval|Number
151749|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72.|Last dose of study drug to Day 72 (60 days)|All participants who received at least 1 dose of study drug during the Treatment Period and entered the Follow-Up Period.||percentage of participants||95% Confidence Interval|Number
151863|NCT00371254|Secondary|Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline|VEGFR2 is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of VEGFR2 were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.||percentage of baseline||90% Confidence Interval|Geometric Mean
151750|NCT00371683|Primary|Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population|ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days.|First dose of study drug to last dose, plus 2 days post last dose|All participants who received at least one dose of study drug (Treated population).||percentage of participants||95% Confidence Interval|Number
151751|NCT00371683|Secondary|Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period|ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From first dose to last dose, plus 2 days (12 days, plus 2)|All participants who received at least one dose of study drug were analyzed (Treated Population).||percentage of participants||95% Confidence Interval|Number
151752|NCT00371683|Secondary|Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period|ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal (or distal, as appropriate) venogram or an adjudicated event associated with the endpoint. n= number analyzed||percentage of participants||95% Confidence Interval|Number
151753|NCT00371683|Secondary|Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period|An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants: PE, Symptomatic DVT, Symptomatic Proximal DVT, Symptomatic Distal DVT. Randomized with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint: All DVT, Asymptomatic DVT. n=number analyzed in each category||percentage of participants||95% Confidence Interval|Number
151754|NCT00371683|Secondary|Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
151755|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
151756|NCT00371683|Secondary|Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
151757|NCT00371683|Secondary|Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
151758|NCT00371683|Secondary|Event Rate for Participants With All-Cause Death During the Intended Treatment Period|Event rate was number of participants with all-cause death divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|All Randomized participants were analyzed.||percentage of participants||95% Confidence Interval|Number
151759|NCT00371683|Secondary|Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
151760|NCT00371683|Secondary|Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period|ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
151864|NCT00371254|Secondary|Mean Change in Concentration of Collagen Type IV From Baseline|Collagen Type IV is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of Collagen Type IV were obtained and analyzed by enzyme-linked immunosorbent assay.|Baseline, Week 3 and Week 5|Participants who were evaluable for pharmacodynamic analysis.||percentage of baseline||90% Confidence Interval|Geometric Mean
151762|NCT00371683|Secondary|Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period|VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant’s analyzed (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with an adjudicated and evaluable bilateral venogram or an adjudicated event associated with the endpoint, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
151763|NCT00371683|Secondary|Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period|A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%).|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Randomized participants with either an adjudicated and evaluable bilateral proximal venogram or an adjudicated non-fatal PE or death, during the Intended Treatment Period, were analyzed.||percentage of participants||95% Confidence Interval|Number
151764|NCT00371683|Primary|Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects|An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization.|From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization|Primary Population=All randomized participants who: have an adjudicated and evaluable bilateral venogram performed during the Intended Treatment Period; or have an adjudicated VTE during the Intended Treatment Period; or die due to any cause during the Intended Treatment Period.||percentage of participants||95% Confidence Interval|Number
151765|NCT00371644|Primary|PTSD Checklist (PCL)|The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.|Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment|Numbers differ from enrollment due to participants excluded from data analysis for poor psychotherapeutic fidelity.||units on a scale||Standard Error|Mean
151766|NCT00371631|Secondary|The Rate of Symptomatic UTI While Colonized|Symptomatic UTI was defined as significant bacteriuria (≥105 cfu/ml) and pyuria (>10 WBC/hpf) plus ≥1 of the following signs and symptoms for which no other etiology could be identified: fever (oral temperature >100°F), suprapubic or flank discomfort, bladder spasm, change in voiding habits, increased spasticity, or worsening dysreflexia. The rate of UTI (number) was calculated by dividing the total number of patient days by the total number of UTIs.|3 years|||UTI/per subject year|||Number
151767|NCT00371631|Primary|Bladder Colonization|Bladder colonization was defined when (≥102 cfu/ml) of E. coli 83972 was detected in urine cultures for > 3 days after catheter removal.|> 3 days, up to 197 days|||percentage of participants|||Number
151768|NCT00371566|Secondary|Relative Change From Baseline of Kep Median (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151769|NCT00371566|Secondary|Relative Change From Baseline of Whole IAUC(90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151786|NCT00371566|Secondary|Comparison of Overall Response During Follow up Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|weeks 19 - 25|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151770|NCT00371566|Secondary|Relative Change From Baseline of Perfused IAUC (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151771|NCT00371566|Secondary|Relative Change From Baseline of IAUC Mean (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151772|NCT00371566|Secondary|Relative Change From Baseline of IAUC Median (90) After 2 - 4 Weeks of Treatment|Dynamic Contrast - enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an intravascularly administered contrast agent from intravascular into the extravascular tissue over time. Initial area under the contrast (IAUC), tracks the concentration versus time curve 90 seconds after contrast injection (IAUC90). By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor microenvironment (e.g., tissue perfusion, vessel permeability, vascular surface area, and extracellular-extra vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151773|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Whole (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151774|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Perfused (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151775|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Mean (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151776|NCT00371566|Secondary|Relative Change From Baseline of Kep Whole (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151812|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Negative|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart||||||
151777|NCT00371566|Secondary|Relative Change From Baseline of Kep Perfused (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151778|NCT00371566|Secondary|Relative Change From Baseline of Kep Mean (1/Min) After 2 - 4 Weeks of Treatment|DCE-MRI tracks the diffusion of an intravascularly administered contrast agent into the extravascular tissue over time. Over a period of time, the contrast agent diffuses back into the vasculature (described by the rate constant or Kep). The lower the Kep, the longer the contrast remains in the extravascular space and is more prolonged. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g., vessel permeability, etc.) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151779|NCT00371566|Secondary|Relative Change From Baseline of Ktrans Median (1/Min) After 2 - 4 Weeks of Treatment|Dynamic Contrast enhanced Magnetic Resonance Imaging (DCE-MRI) tracks the diffusion of an administered contrast agent from -intra into the extravascular tissue over time. Ktrans estimates blood flow and relates to the ease of exchange into extravascular spaces. A volume transfer (i.e, 1/min) constant of contrast agent is used to determine vascular permeability. By plugging DCE-MRI results into an appropriate pharmacokinetic model, physiological parameters of the tumor (e.g.,tissue perfusion, vessel permeability, vascular surface area, and extracellular/vascular volume fraction) are determined.|Baseline, and Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. DCE-MRI population||Percent change||Standard Deviation|Mean
151780|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 5 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 5 are death related to Adverse Event."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
151781|NCT00371566|Secondary|Adverse Events (AEs) by Maximum Toxicity Grade 4 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 4 are life-threatening or disabling Adverse Event (complicated by acute, life-threatening metabolic or cardiovascular complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
151782|NCT00371566|Secondary|Adverse Events by Maximum Toxicity Grade 3 During or After Chemoradiotherapy Phase|"Events which started during or after Chemoradiotherapy Phase. Grade 3 are severe and undesirable Adverse Event (significant symptoms requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation)."|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
151783|NCT00371566|Secondary|Summary of Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
151784|NCT00371566|Secondary|Summary of Fatal/Serious Adverse Events During or After Chemoradiotherapy Phase|Events which started during or After the Chemoradiotherapy Phase. Definition of a serious adverse event is any untoward medicinal occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other.|Week 10 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
151785|NCT00371566|Secondary|Summary of Adverse Events Experienced by 15% or More Subjects in Either Treatment Group|Definition of an adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 1 through 25|Safety population consisted of all randomized subjects who took at least one dose of study medication. This population was based on the actual treatment received, if different to the randomized treatment allocation.||Participants|||Number
151813|NCT00371397|Secondary|Mood: Positive and Negative Affect Schedule (PANAS)Positive|The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.|7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart||||||
151787|NCT00371566|Secondary|Comparison of Overall Response During Treatment Phase Using CT/MRI and PET Information|Position Emission Tomography (PET) scans 3-D images are read alongside CT or magnetic resonance imaging (MRI) scans, the combination gives both anatomic and metabolic information. CT = Computerized axial tomography; a type of x-ray for dense areas of the body. MRI = Magnetic Resonance Imaging which captures a picture using Magnets. Better = improvement in response, Worse = response was downgraded.|Week 2 - 4|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151788|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade (Grade 3 or Higher) Started During or After the Chemoradiotherapy Phase|Toxicity Grading scale 0=none, 1= transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 10 through 25|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
151789|NCT00371566|Secondary|Summary of Adverse Events by Maximum Toxicity Grade Started During Treatment Phase|Toxicity Grading scale 0=none, 1=transient symptom, 2=mild symptom that does not interfere with activities of daily living (ADL's) 3=mild but interfers with ADL's w/o hospitalization. 4=requires hopitalization 5=Death.|Week 1 through Week 6|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
151790|NCT00371566|Secondary|Number of Biomarkers Including Tumor Protein 53 and HPV During Treatment Phase|"Tumor Suppressor p53 is welcomed and described as the guardian angel gene, it conserves stability by preventing genome mutation. Human Papillomavirus (HPV) biomarker is un-welcomed and is found to be an important precursor cancers of the head and neck. HPV biomarkers have the ability to bind to and inactivate the Tumor Suppressor p53 biomarker."|Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151791|NCT00371566|Secondary|Number of Biomarkers Including ErbB1, ErbB2, pErbB1, and pErb2 at Baseline and During Treatment Phase|Estrogen Receptor (ER) variants, ERB-B2 and ERB B-5 consist of the major proportion of ER expression both in normal and cancer tissues. The exact role of these markers are unknown. Acronyms defined: ICH (immunohistochemical) and FISH (fluorescence in situ hybridization).|Baseline and Week 2|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151792|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Chemoradiotherapy Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after chemoradiotherapy numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Chemoradiotherapy (week 10 - 13)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151793|NCT00371566|Secondary|Number of Participants With Circulating Tumor Cells After Treatment Phase in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's) after treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|End of Treatment (week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151794|NCT00371566|Secondary|Number of Circulating Tumor Cells at Baseline in mITT Population|This measures the participants with Circulating Tumor Cells (CTC's)Pre-Treatment numbers of 0 to >= 4. CTC's are tumor cells that escape from the primary tumor into the bloodstream and travel through the circulation to distant sites where they develop into secondary tumors.|Baseline|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis. mITT FOLLOW-UP Population of Circulation Tumor Cells||Participants|||Number
151795|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in ITT Population|Over all: Complete Response (CR) – absence of lesions. Partial Response (PR) - CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)– no PD or Response. Progressive Disease (PD)– PD or new lesions. Not Evaluable(NE)– no other definitions.|Baseline and End of Follow-up (week 19 - 25)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
151796|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in ITT Population|Over all: Complete Response (CR)–absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)–no PD or Response. Progressive Disease (PD)–PD or new lesions. Not Evaluable(NE)– no other definitions.|Baseline and End of Treatment (Week 2 - 6)|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Participants|||Number
151814|NCT00371397|Secondary|Blood Pressure||7:55 at each of the three visits, scheduled at least 2 weeks apart||||||
151815|NCT00371397|Secondary|Heart Rate||Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15||||||
151816|NCT00371397|Primary|Catecholamine Production: Norepinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05||||||
151817|NCT00371397|Primary|Catecholamine Production: Epinephrine|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart||||||
151797|NCT00371566|Secondary|Overall Radiological Response After Follow-up Phase in mITT Population|Over all: Complete Response(CR)–absence of lesions. Partial Response(PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD)in other lesions with no new lesions or progressive disease (PD). Stable Disease(SD)–no PD or Response. Progressive Disease(PD)–PD or new lesions. Not Evaluable(NE)– no other definitions. Number of subjects included those who were considered evaluable if they completed a full course of chemoradiotherapy and were able to provide a baseline and follow-up scan following the completion of chemoradiation.|Baseline and End of Follow-up (Week 19 - 25)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151798|NCT00371566|Secondary|Overall Radiological Response After Treatment Phase in mITT Population|Over all: Complete Response (CR)– absence of lesions. Partial Response (PR)- CR or PR of target lesions and incomplete response (IC) or stable disease (SD) in other lesions with no new lesions or progressive disease (PD). Stable Disease (SD)–no PD or Response. Progressive Disease (PD)–PD or new lesions. Not Evaluable(NE)– no other definitions. Number of subjects included those who had a scan immediately post lapatanib/placebo monotherapy.|Baseline and End of Treatment (Week 2 - 6)|The mITT population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumour biopsy sample for the primary endpoint analysis.||Participants|||Number
151799|NCT00371566|Secondary|Change From Baseline of Cell Proliferation Rate of the Ki-67 Proliferative Index in Tumour Biopsy Samples During Treatment Phase|The Ki-67 protein is expressed in all phases of the cell cycle except G0 (low level phase) and serves as a good marker for cell proliferation. Scoring is assessed by point counting 500 to 1000 cells, and is reported as percent positive cells. 20% positive cells to define “positive” (i.e. high risk)|Baseline and Week 2|The mITT (modified Intent-to-Treat) population consisted of all subjects who were randomised to study treatment, did not miss lapatinib/placebo treatment for more than 7 consecutive days and had provided sufficient tumor biopsy sample for the primary endpoint analysis.||Percent of positive cells||Standard Deviation|Mean
151800|NCT00371566|Primary|Change From Baseline of the Apoptotic Index During Treatment Phase|Apoptotic Index-TUNEL Assay is a method which counts a total of at least 1000 neoplastic nuclei(Cells with morphological changes defining cell death) subdivided in 10 fields chosen randomly at 400x magnification. A ‘responder’ was defined as having 20% cell death.|Baseline and Week 2|The Intent-to-treat (ITT) population comprised of all subjects who were randomised to study treatment, regardless of whether they actually received study medication.||Percentage of positive cells||Standard Deviation|Mean
151801|NCT00371540|Secondary|Death||12 months|||participants|||Number
151802|NCT00371540|Primary|Lost to Follow-up|Number of Subjects Lost to follow-up|12 months|||participants|||Number
151803|NCT00371540|Secondary|Viral Load|Detectable VL at 12 months|12 months|||participants|||Number
151804|NCT00371462|Primary|Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I)|Study was terminated by VA. No VA outcome data to report.|baseline, 3, 6, 9, and 12 months|No data were analyzed due to termination of the study.|||||
151805|NCT00371449|Secondary|Speech Spatial and Qualities of Hearing Scale (SSQ)|The SSQ measures hearing abilities related to speech, spatial perception, and quality of sound using a 1-10 scale. Items are averaged across the test. Higher scores indicate better outcomes.|aided (after wearing hearing aids for at least 3 months)|||units on a scale (points)||Standard Deviation|Mean
151806|NCT00371449|Secondary|Satisfaction With Amplification in Daily Life (SADL)|Measures how satisfied listeners are with their current hearing aids. Total scale scores are computed by averaging the subscale (positive effect, negative features, personal image, and service & delivery) scores that range from 1 (no satisfaction) to 7 (high satisfaction).|aided (after wearing hearing aids for at least 3 months)|||units on a scale (points)||Standard Deviation|Mean
151807|NCT00371449|Secondary|Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)|Measures hearing-aid self-efficacy over four subscales (basic handling, advanced handling, adjustment, and aided listening). Subscale scores are averaged to produce a total self-efficacy scores that can range from 0 (low self-efficacy) to 100 (high self-efficacy).|aided (after wearing hearing aids for at least 3 months)|||% level of self-efficacy||Standard Deviation|Mean
151808|NCT00371449|Secondary|International Outcomes Inventory for Hearing Aids (IOI-HA)|Overall/general hearing-aid outcome measure. Range in scores are 7-35 with higher scores representing better outcomes.|aided (after wearing hearing aids for at least 3 months)|||units on a scale (points)||Standard Deviation|Mean
151809|NCT00371449|Secondary|Acceptable Noise Level Test|"The ANL consists of a speech signal and a competing noise signal. The speech signal is a continuous monologue (Arizona Travelogue) by a male talker and the competing noise signal is the 12-talker babble from the Speech in Noise (SPIN) test (Kalikow et al, 1977). The speech and babble stimuli are recorded on separate channels on a compact disc (CD; Cosmos, Inc.). The task of the listener was to adjust the level of the travelogue to the most comfortable level (MCL) and then to adjust the level of the babble to the level the listener is willing to put up with and still follow the travelogue, or to the background noise level (BNL). The ANL (in dB) is the difference between the MCL and BNL."|aided (after wearing hearing aids for at least 3 months)|||dB||Standard Deviation|Mean
151810|NCT00371449|Primary|Words-in-noise Test|The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.|aided (after wearing hearing aids for at least 3 months)|||dB S/N||Standard Deviation|Mean
151811|NCT00371436|Primary|THI (Tinnitus Handicap Inventory)|The THI (Tinnitus Handicap Inventory) is a statistically validated tinnitus questionnaire that provides an index score, ranging from 0 to 100, with higher scores reflecting greater self-perceived tinnitus handicap.|Baseline, 6 months|The THI was completed by 58 of the 92 PATM patients at both baseline and 6 months. The THI was completed by 68 of the 89 Usual Care patients at both baseline and 6 months.||scores on a scale||Standard Deviation|Mean
151823|NCT00371397|Primary|Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)|Cellophane tape stripping, a common dermatological paradigm for studying restoration of the skin barrier, was used to examine whether the time necessary for recovery from minor physical insults varied by condition or yoga expertise. Measurement of the rate of transepidermal water loss (TEWL) through human skin provides a noninvasive method to monitor changes in the skin’s barrier function. TEWL was measured twice during the session using a computerized evaporimetry instrument, the DermaLab® (CyberDERM, Media, PA), and barrier recovery was calculated.|11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart||||||
151824|NCT00371397|Primary|Cortisol|All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.|Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30||||||
151825|NCT00371397|Primary|Number of Participants With Detectable C-Reactive Protein (CRP)|High sensitivity C-reactive protein (hsCRP) assessed once at baseline, at each of the three visits. The hsCRP assay was performed using chemiluminescence methodology with the Immulite 1000 (Siemens Medical Solutions, Los Angeles, Ca.) The lowest level of detection is .3 mg/dL. 43% of the values were below this lower bound, thus hsCRP was dichotomized as undetectable/detectable.|8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart|||participants with CRP above 0.3|||Number
151826|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 5 of treatment|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
151827|NCT00371345|Primary|Best Overall Response|Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||participants|||Number
151828|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR|VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
151829|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|Week 5|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
151830|NCT00371345|Secondary|Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR|Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.|At Baseline and Week 3 of treatment (Day 15 ±4 days)|Number of Participants Analyzed=All Treated Participants with samples for PD analysis, n=number of participants at specified time point with samples for PD analysis||percent change||90% Confidence Interval|Mean
151831|NCT00371345|Secondary|PK: Plasma Concentration of Dasatinib at Week 7 or Week 9|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis||ng/ml||Standard Deviation|Mean
151832|NCT00371345|Secondary|Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3|Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.|PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).|Number of Participants Analyzed=All Treated Participants with samples for PK analysis, n=number of participants at specified time point with samples for PK analysis||ng/ml||Standard Deviation|Mean
151833|NCT00371345|Secondary|Number Of Participants With Notable Drug-related AEs|Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
151834|NCT00371345|Secondary|Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
151835|NCT00371345|Secondary|Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities|Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
151836|NCT00371345|Secondary|Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug|All-Treated participants: All participants who received at least one dose of dasatinib.||participants|||Number
151837|NCT00371345|Secondary|Duration Of Objective Response|Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment.|the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed|Of 69 response-evaluable participants, three had an objective response of PR.||weeks|||Number
151838|NCT00371345|Secondary|Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25|PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed.|At Weeks 9, 17, and 25|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||percentage of participants|||Number
151839|NCT00371345|Secondary|Median Progression Free Survival (PFS)|PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.||weeks||95% Confidence Interval|Median
151840|NCT00371345|Secondary|Number of Participants Who Progressed|PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed.|From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)|All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks.||participants|||Number
151841|NCT00371345|Secondary|Percentage of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||percentage of participants||95% Confidence Interval|Mean
151842|NCT00371345|Secondary|Number of Response-evaluable Participants With Disease Control (DCR)|Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||participants|||Number
151843|NCT00371345|Primary|Percentage of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|From day of first treatment through Week 25 or at time of discontinuation from study treatment|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).||percentage of participants||95% Confidence Interval|Number
151844|NCT00371345|Primary|Number of Participants With Objective Response|Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.|From day of first treatment through Week 25 or at time of discontinuation from study treatment.|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment. One participant was not evaluable (no on-study tumor assessment for other reason).||participants|||Number
151845|NCT00371267|Secondary|Pain Intensity Rating|Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
151846|NCT00371267|Secondary|Pain Behavior Checklist Total Score|Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
151847|NCT00371267|Primary|Short Form-12 Mental Health|Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores|46 weeks|Veterans with chronic pain||units on a scale||Standard Deviation|Mean
151851|NCT00371254|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECGs were performed and all recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed. The following ECG variables were collected: heart rate, PR interval, QRS width, and QT interval. Abnormalities in ECGs were defined by reference to institutional reports.|Baseline, Weeks 3, 9, 17 and 25, then every 8 weeks until the end of study treatment (up to 17 weeks).|All treated participants||participants|||Number
151852|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Creatinine, Bicarbonate, Inorganic Phosphorous and Bilirubin (Total).|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Creatinine: Grade 3-4 : > 3.0 -6.0 ULN (upper limit of normal),Bicarbonate: Grade 3-4: <16 -<22 mEq/L, Phosphorous: Grade 3-4 : <1.0 - <2.0 mg/dL, Bilirubin, total: Grade 3-4: >3.0 - >10.0 ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
151853|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Calcium, Potassium, Magnesium and Sodium|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: Calcium: Grade 3-4 : <6.0 – <7.0 or >12.5 – >13.5 mg/dL, Potassium: Grade 3-4 : <2.5 – <3.0 or >6.0 – >7.0 mEq/L, Magnesium: Grade 3-4 : <0.6 - <0.8 or >2.46 - >6.6 mEq/L, Sodium:< 120– 130 or >155 – >160 mEq/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
151854|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Serum Chemistry Abnormalities in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grade 3 and 4 criteria are defined as follows: ALT, AST and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
151855|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT)|PTT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants.||Participants|||Number
151856|NCT00371254|Secondary|Number of Participants With Abnormalities (Grade 1 or 2) in Prothrombin Time (PT)|PT is a measure of the clotting ability of the blood. Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening and 5=death.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
151857|NCT00371254|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Hematology Measurements|Abnormalities were graded according to the NCI CTC, version 3.0: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. Grades 3 and 4 criteria are defined as follows: Granulocytes: Grade 3 <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Hemoglobin: Grade 3, <8.0 - 6.5 g/dL; Grade 4, <6.5 g/dL. Platelets: Grade 3, <50.0 - 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Leukocytes: Grade 3, <2.0 - 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L.|Throughout study, from start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
151858|NCT00371254|Secondary|Most Frequent Drug-related Adverse Events (AEs)|Most frequent drug-related AEs are those AEs with frequency >=25% in either group. Drug-related AEs are those events with relationship to study therapy of certain, probable or possible.|From start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
151859|NCT00371254|Secondary|Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3 AEs and Discontinuations Due to Drug-related AEs|AE=any new untoward medical occurrence/worsening of pre-existing medical condition.SAE=AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event. Drug-related SAEs or AEs are those events with relationship to study therapy of certain, probable or possible.AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), v3: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death.Participants who discontinued the study due to any drug-related AEs were also recorded.|From start of study drug therapy up to 30 days after the last dose.|All treated participants||participants|||Number
151860|NCT00371254|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose.|All treated participants.||participants|||Number
151861|NCT00371254|Secondary|Profiling of Messenger-ribonucleic Acid (mRNA) Expression: mRNA Signal Intensity|Pharmacogenomic analysis included the assessment of the relationship between clinical benefit and mRNA expression levels and between clinical benefit and protein phosphorylation. Tumor mRNA expression was analyzed in all available tissues. mRNA was extracted from 96 formalin-fixed paraffin-embedded tissue (FFPET) samples, amplified, and fluorescently labeled. Gene expression profiling was conducted using Affymetrix Human Genome U133A 2.0 DNA microarrays. mRNA expression is reported as quantile normalized RMA values.|Baseline|All treated participants who were evaluable for the analysis. These data for pharmacogenomic analyses were integrated with those from other studies and are not reportable for this study alone.||log2 scale (unitless)|||Number
151862|NCT00371254|Secondary|Percentage Change in Tumor Biomarkers|Tumor markers are indicators of tumor activity which may be used to predict clinical benefit and circulating biomarkers may reveal key mechanisms of action. Tissue staining was performed for caveolin, phospho-caveolin, EphA2 and insulin-like growth factor binding protein 2 (IGFBP2) markers using immunohistochemistry assays.|Baseline|All treated participants who were evaluable for the analysis. These data for tumor markers were integrated with those from other studies and are not reportable for this study alone.||percentage||Inter-Quartile Range|Median
151865|NCT00371254|Secondary|Mean Plasma Concentration at Week 7|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."||nanograms (ng)/mL||Standard Deviation|Mean
151866|NCT00371254|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug were included in this dataset.||percentage of participants||95% Confidence Interval|Number
151867|NCT00371254|Secondary|Mean Plasma Concentration at Week 3|Mean plasma concentration was obtained directly from the concentration-time data.|At pre-dose and 1, 3, 6 and 12 hours after each dose administration|"Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point."||nanograms (ng)/mL||Standard Deviation|Mean
151868|NCT00371254|Secondary|Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)|Mean number of weeks of CR/PR (time from first date of CR/PR until first date PD observed. Tumor response defined per RECIST: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in sum of LDs of target lesions relative to baseline sum LD; PD: appearance of new lesion or >=20% increase in sum of LD of target lesions relative to smallest sum LD or unequivocal progression of existing non-target lesions. Participants who died without reported PD were considered to have PD on date of death. For participants who neither progressed nor died, date of last tumor assessment used.|Baseline to end of study drug therapy (up to 53.86 weeks)|Response-evaluable participants who achieved a complete response (CR) or partial response (PR)||weeks||Full Range|Mean
151869|NCT00371254|Secondary|Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25|PFS:time from first dose until the date that progressive disease (PD) or clinical PD (cPD) observed,per RECIST criteria.PD:appearance of new lesion/s,or >=20% increase in the sum of the LD of target lesions,relative to smallest sum LD recorded since treatment start,or unequivocal progression of existing non-target lesions;cPD:deterioration related to disease requiring treatment discontinuation,but without radiographic PD.Participants who died without PD were considered to have PD on the date of death.For participants who neither progressed nor died,date of the last tumor assessment was used.|Weeks 9, 17, and 25|All treated participants||Proportion of Participants|||Number
151870|NCT00371254|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The percentage of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.||percentage of participants||95% Confidence Interval|Number
151871|NCT00371254|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study|The number of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: >=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.|Baseline to 16 weeks.|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.||Participants|||Number
151872|NCT00371254|Primary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.|Baseline to end of study drug therapy (up to 65 weeks).|All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug.||participants|||Number
151873|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|6 month follow-up|||units on a scale||Standard Deviation|Mean
151874|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|3 month follow-up|||units on a scale||Standard Deviation|Mean
151875|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Post intervention|||units on a scale||Standard Deviation|Mean
151876|NCT00371176|Secondary|Beck Depression Inventory|A 21-item, self-report measure of depression symptoms. The range of scores is 0-63, with a higher value representing a worse outcome.|Pre intervention|||units on a scale||Standard Deviation|Mean
151877|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|6 month follow-up|||units on a scale||Standard Deviation|Mean
151878|NCT00371176|Secondary|PTSD Checklist|A 17-item, self-report measure of PTSD symptoms. The range of scores is 17-85, with a higher value representing a worse outcome.|3 month follow-up|||units on a scale||Standard Deviation|Mean
151885|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry|The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:>1.25xULN, Aspartate aminotransferase:>1.25xULN, Alkaline Phosphatase:>1.25xULN, Total Bilirubin:>1.1xULN, Serum Lipase:>1.10xULN, Creatinine:>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.||participants|||Number
151886|NCT00371150|Primary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA < 50 IU/mL = approximately <300 copies/mL.|Week 48 of ETV treatment|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants||95% Confidence Interval|Number
151887|NCT00371150|Secondary|Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology|Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.|OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up|All treated participants. n = number of participants in the OF period.||participants|||Number
151888|NCT00371150|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From enrollment through Week 52 + 5 days|All treated participants.||participants|||Number
151889|NCT00371150|Secondary|Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis||Week 48|Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed.||percentage of participants|||Number
151890|NCT00371150|Secondary|Mean log10 Reduction From Baseline in HBV DNA at Week 48|HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.|baseline, Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.||log10 IU/mL||Standard Error|Mean
151891|NCT00371150|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
151892|NCT00371150|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.|Week 48|All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
151893|NCT00371150|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
151894|NCT00371150|Secondary|Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)|HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week|Week 48|Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.||percentage of participants|||Number
151895|NCT00371150|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants|||Number
151896|NCT00371150|Secondary|Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV|Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant’s nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)|through Week 48|All treated participants. The participants who discontinued prior to Week 48 were counted as failure.||percentage of participants|||Number
151897|NCT00371150|Secondary|Percentage of Participants With HBV DNA by PCR Category at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants|||Number
151898|NCT00371150|Secondary|Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48|HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.|Week 48|All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.||percentage of participants||95% Confidence Interval|Number
152050|NCT00369746|Secondary|Quantitative Substance Use Inventory ((SUI)|"Quantitative Substance Use Inventory ((SUI) Measure substance use~Administered at either week 12 or 14: Any Illicit Drug Using in last 30 days"|30 days|All participants who met entry criteria for alcohol abuse or dependence per protocol.||Days||Standard Deviation|Mean
151899|NCT00371137|Primary|Pain VAS (Visual Analog Scale) Response. Percentage of Subjects With a Greater Than or Equal to 30% Reduction in Pain VAS From Baseline (BOCF).|Percentage of pain VAS responders. Subjects with a >= 30% reduction in pain VAS from baseline to endpoint (week 14) were considered responders; all other subjects were considered non-responders. Missing data were handled using BOCF (Baseline Observation Carried Forward). The pain VAS ranges from 0 (no pain) to 100 (worst imaginable pain). The pain VAS was collected morning, afternoon and evening. Baseline is the average value recorded for the measure during the week prior to the end-of-baseline visit. Endpoint is the average value recorded for the measure during the week prior to week 14.|Baseline to Week 14|||Percentage of Participants|||Number
151900|NCT00370994|Secondary|Functional Status|Oswestry Disability Index (ODI) – ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.|3, 6, 12, 18 and 24 months post treatment.|||units on a scale||Standard Deviation|Mean
151901|NCT00370994|Primary|Numeric Pain Rating Score|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable|3, 6, 12, 18 and 24 months post treatment.|Sample size is calculated based on reduction of NRS. A 25% clinical difference change of 1.15.||units on a scale||Standard Deviation|Mean
151902|NCT00370838|Primary|Total Tic Score|The TTS is a portion of the YGTSS [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). A score of 0 represent no tics present, a score of 50 represents the most severe tics in each category listed.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
151903|NCT00370838|Secondary|Modified Pittsburgh Side Effect Scale|"Side effects will be assessed by an expanded (modified) Pittsburgh Side Effect Scale modified to include side effects of levetiracetam and clonidine. Significant adverse events will be reported to the UCB, JCCI, and FDA within 24 hours. Positive responses are tallied as number of side effects for the responding period."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||Number of Side Effects||Standard Deviation|Mean
151904|NCT00370838|Secondary|Multidimensional Anxiety Scale for Children (MASC):|"The child's anxiety will be followed using the multidimensional Anxiety Scale for Children (MASC) (Stallings and March, 1995) and is now considered the preferred instrument for rating childhood anxiety. It is a 39-item questionnaire, ranking each item as Never, Rarely, Sometimes, or Often (0, 1, 2, 3). The sum of all responses yeilds a score (maximum MASC score is 117). A score of 0 represents no anxiety, and a score of 117 represents severe anxiety."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
151905|NCT00370838|Secondary|DuPaul Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale:|The presence of Attention Deficit Hyperactivity Disorder (ADHD) symptoms are assessed using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) version of the DuPaul ADHD rating scale, which incorporates the symptom items for ADHD from the DSM into a rating scale format that quantifies symptom severity. Each item is rated as not at all, just a little, pretty much, and very much (0, 1, 2, and 3). There are 18 items in total are summed, with a minimum score of 0 (meaning no inattention or hyperactivity) with a maximum score of 54 (severe inattention and hyperactivity).|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
151906|NCT00370838|Secondary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS):|The severity of obsessive-compulsive disorder (OCD) is evaluated using the CY-BOCS [Scahill et al 1997]. Obsessions and compulsions are rated on 5 separate scales yielding three summary scores: Obsessions (0-20), Compulsions (0-20) and Total score (0-40). The CY-BOCS is the most widely used instrument to assess the severity of OCD symptoms in research studies. It includes checklist of specific obsessions and compulsions followed by examiner ratings of time spent, interference, distress, resistance and control over the obsessions and compulsions.0=no obsessions or compulsions; 40=most severe OC|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
151907|NCT00370838|Secondary|Clinical Global Impression-Improvement (CGI-I):|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to very much improved; 2 equals much improved; 3 denotes minimal change; and 4 represents no change. Scores above 4 are used to indicate deterioration, i.e., 5 equals minimally worse; 6 is much worse; and 7 is very much worse."|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
151908|NCT00370838|Primary|Yale Global Tic Severity Scale (YGTSS):|The YGTSS is a semi-structured clinical interview designed to measure current tic severity [Leckman et al., 1989], and consists of separate rating of motor (0-25) and vocal (0-25) tics. Ratings are made along 5 discriminant dimensions, scaled 0-5 for each including number, frequency, intensity, complexity, and interference. Total of these scores (0-50) is a Total Tic Score (TTS). The YGTSS contains an impairment ranking, 0-50 points, based on the impact of the tic disorder on areas such as self esteem, family life, social acceptance, and school. 0=no tics present; 100=most severe tics.|Baseline (Day 8 or Day 64), Final (6 weeks later: Day 50 or Day 106)|||scores on a scale||Standard Deviation|Mean
151909|NCT00370552|Secondary|Number of Participants With Abnormalities in Renal Function by Worst CTC Grade|Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.||Participants|||Number
151910|NCT00370552|Secondary|Number of Participants With Abnormalities in Liver Function by Worst CTC Grade|ULN=Upper limit of normal.ALT Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; AST Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; ALP Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Total bilirubin Gr 1: >ULN to 1.5*ULN, Gr 2: >1.5 to 3.0*ULN, Gr 3: >3.0 to 10.0*ULN, Gr 4: >10.0*ULN.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug and had samples available.||Participants|||Number
151911|NCT00370552|Secondary|Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade|CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L; Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.|At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle|All randomized participants who received any study drug.||Participants|||Number
151912|NCT00370552|Primary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants||Participants|||Number
151913|NCT00370552|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug|All randomized participants who received any study drug.||Participants|||Number
151914|NCT00370552|Secondary|Percentage of Participants Surviving at 1 Year|One year survival rates were computed using Kaplan-Meier estimates.|Date first participant enrolled to 1 year|All randomized participants.||Percentage of participants||95% Confidence Interval|Number
151915|NCT00370552|Secondary|Median Duration of Response|Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.||Months||95% Confidence Interval|Median
151916|NCT00370552|Secondary|Median Time to Response|Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR.|Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)|Participants whose best response was CR or PR, as assessed by the investigator.||Weeks||Full Range|Median
151917|NCT00370552|Secondary|Median Progression-free Survival (PFS)|PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment.|Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)|All randomized participants.||Months||95% Confidence Interval|Median
151918|NCT00370552|Secondary|Percentage of Participants With Progression-free Survival at Week 24|Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months.|Date of randomization to Week 24|All randomized participants||Percentage of participants||95% Confidence Interval|Number
151919|NCT00370552|Primary|Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study|CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.|Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression|All randomized participants||Percentage of participants||95% Confidence Interval|Number
151920|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the MEI-SF Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Scores could range from 0 (worst possible) to 72 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-72)||Standard Deviation|Mean
151921|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores for the FACT-Th Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Scores could range from 0 (worst possible) to 24 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-24)||Standard Deviation|Mean
151922|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the FACIT-F Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of chronic illness therapy fatigue (FACIT-F) questionnaire. Scores could range from 0 (worst possible) to 52 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-52)||Standard Deviation|Mean
152123|NCT00369278|Secondary|Time to “Event” for the Composite Endpoint as Well as All Individual Components of That Endpoint “Treatment Failure” Including Clinical Rejections|Due to a small number of events, median time to <event> was not reached.|6 months||||||
151923|NCT00370331|Secondary|HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment|Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).|Baseline, Week 6, Week 14, and Week 26/Early Withdrawal|ITT Population||Points on a scale (0-100)||Standard Deviation|Mean
151924|NCT00370331|Secondary|WHO Bleeding Scale|Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding|Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits|ITT Population||Percentage of participants|||Number
151925|NCT00370331|Secondary|Percentage of Participants With a Reduction in Use of Baseline ITP Medication|Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use|From Day 1 through Week 26 on-treatment|ITT Population||Percentage of participants|||Number
151926|NCT00370331|Secondary|Maximum and Total Weeks of Platelet Response|Response is defined as a platelet count between 50,000 and 400,000 platelets per microliter.|Day 1 through Week 26 on-treatment|ITT Population||Weeks||Full Range|Median
151927|NCT00370331|Secondary|Percentage of Participants Initiating Rescue Treatment On-therapy|Percentage of participants initiating new ITP medication, an increased dose of concomitant ITP medication from baseline, platelet transfusion, or splenectomy.|Anytime from Day 1 to Week 26|All participants randomized to receive placebo or eltrombopag treatment||Percentage of participants|||Number
151928|NCT00370331|Secondary|Summary of Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Day 8 through Week 26 on-treatment; and 1, 2, 4 week follow-up visits|ITT Population||platelets/microliter (ul)||Full Range|Median
151929|NCT00370331|Primary|Percentage of Responders|The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment|Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment|Intent-to-Treat (ITT) Population: all randomized participants||Percentage of participants|||Number
151930|NCT00370292|Primary|Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|Number of participants who received at least one dose of study drug.||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
151931|NCT00370292|Secondary|Best Objective Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured response (every 14 days for 6 cycles)|Number of participants who received at least one dose of study drug.||participants|||Number
151932|NCT00370292|Primary|Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3|dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).|pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)|All participants who received at least one dose of study drug.||mRNA relative values (ratio with GAPDH)||Standard Deviation|Mean
151933|NCT00370149|Secondary|Death|Patient Death during hospitalization.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.||participants|||Number
151934|NCT00370149|Secondary|Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter|A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.|Participants were followed for the duration of hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.||participants|||Number
151935|NCT00370149|Primary|Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days|Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.|Participants were followed for the duration of the hospital stay, an average of 6 days.|The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.||participants|||Number
151936|NCT00370071|Secondary|Percentage of Subjects Without EDSS Progression|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability.The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability. An EDSS progression was defined as increase in EDSS greater than or equal to (>=) 1.0 points (in the treatment period as compared to baseline).|Baseline up to Week 24|FAS||percentage of subjects|||Number
151937|NCT00370071|Secondary|Expanded Disability Status Scale (EDSS)|The EDSS is a scale based on the standardized neurological examination which comprised of optic, brain stem/cranial nerves, pyramidal, cerebellar, sensory, vegetative, and cerebral functions, as well as walking ability. The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability.|Pre-treatment on Day 1, Week 24|FAS subjects with EDSS assessments at the end of the study (Week 24)||Scores on a scale||Standard Deviation|Mean
151938|NCT00370071|Secondary|Assessment of Relapses: Relapse Severity|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. A major relapse was defined based on changes on EDSS with the following additional criteria to be met: objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS score or increase of the total EDSS score. Relapses which did not meet the criteria of major relapses were considered as non-major.|Baseline up to Week 24|FAS with all subjects who had reported relapses||relapses|||Number
151939|NCT00370071|Secondary|Assessment of Relapses: Percentage of Relapse-free Subjects After 24 Weeks|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment.|After 24 weeks|FAS||percentage of subjects|||Number
151940|NCT00370071|Secondary|Assessment of Relapses: Number of Relapses|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature >37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints, and same subjects were counted more than once under each category.|3 and 6 months|FAS with all subjects who had reported relapses||relapses|||Number
151941|NCT00370071|Secondary|Assessment of Relapses: Relapse Rate|A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical event. The abnormality must be present for at least 24 hours and occur in the absence of fever (axillary temperature more than (>) 37.5 degree celsius / 99.5 degree fahrenheit) or known infection. A relapse must be confirmed by a documented report from a physician or by objective assessment. The relapse rate was calculated on an annualized basis. Annualized relapse rate is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all subjects in the group divided by the sum of the number of days on study of all subjects in the group and multiplied by 365.25.|Baseline up to Week 24|Full analysis set (FAS)||relapses per year|||Number
151942|NCT00370071|Secondary|Number of T2 Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS||Lesions||Standard Deviation|Mean
151943|NCT00370071|Secondary|Number of New Gadolinium (T1)-Enhancing Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS||Lesions||Standard Deviation|Mean
151944|NCT00370071|Secondary|Volume of Gadolinium-enhancing Lesions at Baseline, Weeks 12 and 24|In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.|Baseline, Weeks 12 and 24|MRS||cubic millimeter (mm^3)||Standard Deviation|Mean
151945|NCT00370071|Secondary|Difference Between the Number of New or Enlarging T2 Lesions Per 3 Months During the 6-month Treatment Period and the Number of New or Enlarging T2 Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new or enlarging T2 lesions during the 3-month pre-treatment period from the cumulative number of new or enlarging T2 lesions during the 6-month treatment period divided by 2 (number of new T2 lesions per three months) based on non-enhancing lesions on T1 weighted scans|after 6 months of treatment as compared to the 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.||lesions||Full Range|Median
151946|NCT00370071|Secondary|Difference Between the Number of New Gadolinium (Gd)-Enhancing Lesions Per 3 Months During the 6-month Treatment Period and the Number of New Gd-enhancing Lesions During 3-month Pre-treatment|This secondary endpoint (component of the primary endpoint) was calculated by subtracting the number of new Gd-enhancing lesions during the 3-month pre-treatment period from the cumulative number of new Gd-enhancing lesions during the 6-month treatment period divided by 2 (number of new Gd-enhancing lesions per three months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.||lesions||Full Range|Median
151947|NCT00370071|Primary|Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment|The primary efficacy variable was calculated by subtracting the number of newly active lesions during the 3-month pre-treatment period from the cumulative number of newly active lesions during the 6-month treatment period divided by 2 (number of newly active lesions per three months, new lesion frequency per 3 months)|after 6 months of treatment as compared to 3-month pre-treatment|The primary analysis set included all MRS (MRI set) patients who had at least one dose of study drug and at least one evaluable post-baseline MRI scan. The primary endpoint data was missing for one patient.||lesions||Full Range|Median
151948|NCT00370032|Secondary|Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Population: modified per protocol to include placebo information only.||ml per minute per 100 grams of tissue||Standard Deviation|Mean
151949|NCT00370032|Secondary|Rectal Mucosal Blood Flow (MBF)|On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|||ml per minute per 100 grams of tissue||Standard Deviation|Mean
151950|NCT00370032|Primary|Left Colon Mucosal Blood Flow (MBF)|On Day 6 of each treatment period; 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There were no pre-treatment LDF procedure, MBF was compared between the Healthy volunteers and D-irritable bowel syndrome (IBS) cohorts using the flow rates from the placebo treatment period.|Day 6 after each treatment period|Per Protocol Population - the population used for the primary and secondary outcome analyses. The population consisted of all randomized subjects who completed the study with MBF measurements for both treatment periods.||ml per minute per 100 grams of tissue||Standard Deviation|Mean
151951|NCT00369967|Secondary|Patient Satisfaction|Rating of patient satisfaction with method|3, 6, and 12 months|None of the participants returned their satisfaction survey|||||
151952|NCT00369967|Secondary|Bleeding Profile||3, 6, and 12 months|None of the participants returned their menstrual calendars to assess this outcome|||||
151953|NCT00369967|Secondary|Pregnancy|Number of pregnancies reported|3,6, and 12 mo|There were no reported pregnancies during the study period||participants|||Number
151954|NCT00369967|Primary|Method Continuation at 12 Months|Participants reporting continuation with method at 12 months|12 months|Participants enrolled||participants|||Number
151955|NCT00369967|Primary|Method Continuation at 6 Months|Participants reporting continuation of method at 6 months|6 months|Participants enrolled||participants|||Number
151956|NCT00369967|Primary|Continuation With the Contraceptive Method|Participants reporting continuation with contraceptive method at 3 months|3 months|Number using method at 3 months||participants|||Number
151957|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151958|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151959|NCT00369941|Secondary|Number of Participants Discontinued With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151960|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151961|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151962|NCT00369941|Secondary|Number of Participants Discontinued With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151963|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151974|NCT00369941|Secondary|Number of Participants With LAEs at Week 96|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151964|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151965|NCT00369941|Secondary|Number of Participants With Serious Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151966|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151967|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151968|NCT00369941|Secondary|Number of Participants With Serious LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151969|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 240|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151970|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 156|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151971|NCT00369941|Secondary|Number of Participants With Drug-related LAEs at Week 96|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151972|NCT00369941|Secondary|Number of Participants With LAEs at Week 240|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151973|NCT00369941|Secondary|Number of Participants With LAEs at Week 156|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151989|NCT00369941|Secondary|Number of Participants That Died by Week 96|All participant deaths in the span of 96 weeks on study were recorded.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151975|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151976|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151977|NCT00369941|Secondary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151978|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151979|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151980|NCT00369941|Secondary|Number of Participants That Discontinued With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151981|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151982|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151983|NCT00369941|Secondary|Number of Participants That Discontinued With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151984|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151985|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151986|NCT00369941|Secondary|Number of Participants That Discontinued With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151987|NCT00369941|Secondary|Number of Participants That Died by Week 240|All participant deaths in the span of 240 weeks on study were recorded.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151988|NCT00369941|Secondary|Number of Participants That Died by Week 156|All participant deaths in the span of 156 weeks on study were recorded.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152124|NCT00369278|Secondary|Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180|Due to a small number of events, median time to <event> was not reached.|6 months||||||
151990|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 240|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151991|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 156|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151992|NCT00369941|Secondary|Number of Participants With Serious Drug-related CAEs at Week 96|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151993|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 240|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151994|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 156|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
151995|NCT00369941|Primary|Number of Participants Discontinued With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse events (AEs) in this study were defined as drug-related if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151996|NCT00369941|Primary|Number of Participants Discontinued With LAEs at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151997|NCT00369941|Primary|Number of Participants With Serious Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151998|NCT00369941|Primary|Number of Participants With Drug-related LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
151999|NCT00369941|Primary|Number of Participants With Serious LAEs at Week 48|"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose."|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
152000|NCT00369941|Primary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48|A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
152001|NCT00369941|Primary|Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152002|NCT00369941|Primary|Number of Participants That Discontinued With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152003|NCT00369941|Primary|Number of Participants That Discontinued With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152004|NCT00369941|Primary|Number of Participants That Discontinued With CAEs at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152005|NCT00369941|Primary|Number of Participants That Died by Week 48|All participant deaths in the span of 48 weeks on study were recorded.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152006|NCT00369941|Primary|Number of Participants With Serious Drug-related CAEs at Week 48|"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152007|NCT00369941|Primary|Number of Participants With Drug-related CAEs at Week 48|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152008|NCT00369941|Primary|Number of Participants With Serious CAEs at Week 48|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152009|NCT00369941|Primary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|48 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152010|NCT00369941|Secondary|Number of Participants With Drug-related CAEs at Week 96|"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment."|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152011|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 240|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152012|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 156|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152013|NCT00369941|Secondary|Number of Participants With Serious CAEs at Week 96|Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152014|NCT00369941|Secondary|Number of Participants With CAEs at Week 240|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|240 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152015|NCT00369941|Secondary|Number of Participants With CAEs at Week 156|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|156 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152016|NCT00369941|Secondary|Number of Participants With CAEs at Week 96|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|96 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152017|NCT00369941|Secondary|Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8|Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression|8 Weeks|All participants who took study medication were included in the analysis.||Participants|||Number
152018|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 240|Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)|Baseline and Week 240|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
152019|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
152020|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.|240 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
152021|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 156|Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)|Baseline and Week 156|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
152022|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
152023|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.|156 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
152024|NCT00369941|Secondary|Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)|Baseline and Week 96|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
152025|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
152026|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.|96 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
152027|NCT00369941|Secondary|Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)|Baseline and Week 48|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
152028|NCT00369941|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in this analysis.||Participants|||Number
152029|NCT00369941|Primary|Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.|48 Weeks|All participants who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
152030|NCT00369928|Primary|Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks|percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks|12 weeks|||percent meeting ACR 20||95% Confidence Interval|Number
152031|NCT00369915|Secondary|Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale (HARS) has a range of scores from 0 to 56 where the highest values indicate the most anxiety.|Each of 12 sessions.|Only study completers were analyzed.||units on a scale||Standard Deviation|Mean
152032|NCT00369915|Primary|Change in Depression Severity|The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression.|Outcome measures obtained at each of 12 sessions|Only participants who completed the trial were included in the analysis.||units on a scale||Standard Deviation|Mean
152033|NCT00369824|Secondary|Number of Subjects Reporting Medically Significant Adverse Events (AEs)|Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)|||subjects|||Number
152034|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)|||subjects|||Number
152035|NCT00369824|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)|||subjects|||Number
152036|NCT00369824|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 30-day period following each vaccination|||subjects|||Number
152037|NCT00369824|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least||subjects|||Number
152038|NCT00369824|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 7-day period following each vaccination|Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least||subjects|||Number
152039|NCT00369824|Secondary|Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response|"Vaccine responses for anti-A, C, Y and W-135 defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)~For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer"|One month after vaccination with Menactra|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups||subjects|||Number
152040|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN|"Booster responses defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,~For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,~For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix + Cervarix groups.||subjects|||Number
152041|NCT00369824|Secondary|Number of Subjects With Booster Response for Anti-D and Anti-T|"Booster responses for anti-D and anti-T defined as:~For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)~For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer"|One month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||subjects|||Number
152042|NCT00369824|Secondary|Concentration of Anti-D and Anti-T Antibodies|Concentrations given as Geometric Mean Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||International Unit per Milliliter||95% Confidence Interval|Geometric Mean
152043|NCT00369824|Secondary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups||subjects|||Number
152044|NCT00369824|Secondary|Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values|Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.|Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity at Month 12/13||subjects|||Number
152045|NCT00369824|Primary|Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies|Titers given as Geometric Mean Titers (GMTs)|Before and one month after vaccination with Menactra|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month1 and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups.||Titer||95% Confidence Interval|Geometric Mean
152046|NCT00369824|Primary|Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies|Concentrations given as Geometric Means Concentrations (GMCs)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
152047|NCT00369824|Primary|Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)|Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)|Before and one month after vaccination with Boostrix|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, Month 1 and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.||subjects|||Number
152048|NCT00369746|Secondary|Timeline Follow Back (TLFB) Maximum Drinks Per Drinking Day|This variable reports maximum drinks per drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol||drinks||Standard Deviation|Mean
152051|NCT00369746|Secondary|Timeline Follow Back (TLFB) Average Drinks Per Drinking Day|This variable reports average drinks/drinking day in a pre-defined time frame.|30 days|Subjects who met entering criteria for alcohol abuse or alcohol dependence per protocol||drinks per drinking day||Standard Deviation|Mean
152052|NCT00369746|Primary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range:~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total scoring ranges (0-48):~0-5, No Depression Likely 6-10, Possibly Mildly Depressed 11-15, Moderate Depression 16-20, Severe Depression 21 or Over, Very Severe Depression"|study exit visit, at Week 12|All participants who met entry criteria for alcohol abuse or dependence per protocol.||units on a scale||Standard Deviation|Mean
152053|NCT00369681|Secondary|Addition of Information to Fludeoxyglucose F 18 Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers||5 years||||||
152054|NCT00369681|Secondary|Event-free Survival|Percentage of participants who did not experience death, relapse, or progression (worsening) of their lymphoma.|3 years|All evaluable participants.||percentage of participants||95% Confidence Interval|Number
152055|NCT00369681|Primary|Relationship Between Marker Detection and Clinical Outcome|Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.|3 years|Only 21 participants had a detectable CD27(+) ALDH(+) clone prior to study intervention. The remaining participants either did not have such a clone or did not have a sample tested to look for a clone.||relapses|||Number
152056|NCT00369681|Primary|Impact of Rituximab on Plasma DNA Biomarkers||5 years||||||
152057|NCT00369668|Primary|Fractionated Reaction Time|Premotor reaction times in milliseconds were recorded for the impaired arm of each participant in the three intervention (arm) groups. Premotor reaction time represents central processes. Lower times are faster reaction times, indicating less time to initiate a movement.|Baseline/pretest; posttest given between days 17-22 (posttest days 3-8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Premotor reaction data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.||milliseconds||Standard Error|Median
152058|NCT00369668|Primary|Fugl-Meyer Upper Extremity Motor Test|FM motor test assesses functional impairments post stroke as participants attempt various movements from daily activities. Minimum score = 0; maximum score = 66; lower scores indicate more impairments and higher scores indicate less impairments.|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.||units on a scale||Standard Deviation|Mean
152059|NCT00369668|Primary|Box and Block Test; Data Collected = Number of Blocks Moved|"A 60 second timed hand/arm manipulation test in which participants reach, grasp, lift, and release a 1 x 1 block of wood. They must lift a block from one side of a box, carry it over a low barrier and release the block into the other side of the box."|Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)|All participants who completed the bilateral training protocols were submitted to statistical analysis. Data for all participants were collected twice: (a) baseline/pretest: before treatment and (b) posttest: after treatment.||Blocks||Standard Deviation|Mean
152060|NCT00369655|Secondary|Number of Participant With Previous Treatment of Anti-HER2 With Cardiac Events||Up to 5 years|All participants who have received previous treatment with anti-HER2.||Participants|||Number
152061|NCT00369655|Secondary|Median Duration of Response|Duration of response was defined as for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.|Up to 5 years|Analysis population included only patients who have achieved a confirmed tumor response. The duration of response of 4.6 months is reported from one patient.||Months||95% Confidence Interval|Median
152062|NCT00369655|Secondary|Overall Survival|Overall survival time was defined as the number of months from registration to the date of death or last follow-up|Time from registration to death or last follow up (up to 5 years)|||Months||95% Confidence Interval|Median
152063|NCT00369655|Secondary|Progression Free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who died without documentation of progression being considered to have progressed on the date of their death.|Time from registration to disease progression or death (up to 5 years)|||Months||95% Confidence Interval|Median
152064|NCT00369655|Primary|Proportion of Patients Receiving Vascular Endothelial Growth Factor (VEGF) Trap With 6-month Progression-free Survival|The 6-month progression free survival rate was defined as the proportion of efficacy-evaluable patients on study treatment and progression-free 6 months from registration. Patients who died without documentation of progression will be considered to have progressed on the date of their death.|6 months|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.||Participants|||Number
152065|NCT00369655|Primary|Proportion of Patients With Confirmed Tumor Response|Confirmed tumor response was defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria on 2 consecutive evaluations at least 8 weeks apart.|Up to 5 years|All participants who have met the eligibility criteria, who have signed a consent form and have begun treatment were evaluable for response.||Participants|||Number
152066|NCT00369590|Secondary|Overall Survival|all patients alive as of the last contact were censored for survival on the basis of that contact date|3 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis||weeks||Full Range|Median
152125|NCT00369278|Secondary|Number of Participants With Single Treatment Failures|"Rates for all individual components of the primary endpoint ‘treatment failure’ until day 180:~Acute rejection diagnosed by biopsy (BPAR)~graft loss~death~loss to follow up~discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity)~conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)"|6 months|Intent-to-treat population||Participants|||Number
152067|NCT00369590|Secondary|Progression Free Survival (PFS) Rate for Subjects With Radiographic Response|"pts with confirmed radiographic response and their rate of progression (PFS).~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|up to 3 years|"Arm1 had total of 7 pts with response however, 2 pts stopped treatment early and were censored at 6 and 10 weeks.~Arm 2 had total to 7 pts with response however 1 pt stopped treatment after 2 weeks but had a 4 week scan showing PR. - pt was censored."||weeks||95% Confidence Interval|Median
152068|NCT00369590|Primary|Safety Profile - Events That Discontinued Treatment|number of patients who experienced toxicity that led to being taken off treatment|Approximately 1 year (start of treatment - end of treatment)|||participants|||Number
152069|NCT00369590|Primary|Safety Profile - Toxicities|number of cycles patient was able to have before developing a toxicity that required removing the patient from treatment. Treatment: Aflibercept 4mg/kg intravenously on day 1 of every 14-day cycle - 2 week cycle.|Start to End of treatment 39 cycles or 1yr 7.5months (78 weeks)|||cycles||Full Range|Median
152070|NCT00369590|Secondary|Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response|"pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression. All responders were centrally reviewed for confirmation~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|Up to 2 years|The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis||participants|||Number
152071|NCT00369590|Primary|Progression-free Survival (PFS) at 6 Months|"This design yields 85% power to detect a true 30% 6-month PFS rate, while maintaining .91 probability of rejecting for a true 15% 6-month PFS rate.~pts had MRIs at screening and at the 3rd and 5th cycles then every 8 weeks until progression.~Response determined by modified MacDonald Criteria Complete Response (CR): Complete disappearance of all measurable and evaluable disease, no new lesions. no steroids Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable lesions. no new lesions. steroid dose no > than maximum dose used in first 8 weeks of treatment.~Stable: Does not qualify for CR, PR, or progression steroid dose no > than maximum dose used in first 8 weeks of treatment.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no increase) Clear clinical worsening."|6 months|"pts not known to be progression free at time of the 6-month scan (24weeks) were considered to experienced treatment failure. If at least 10pts (24%) are progression-frree at 6months (GBM) the agent will be considered promising for futher study.~The 3 pts in Arm 2 were treated at 2nd recurrence and were excluded from final efficacy analysis"||percentage of participants|||Number
152072|NCT00369564|Secondary|Ability to Receive All Scheduled Doses of Vincristine|We will determine if a greater proportion of patients receiving l-glutamic acid hydrochloride are able to receive 100% of their scheduled doses of vincristine as compared to those in the placebo control group|10 weeks||||||
152073|NCT00369564|Secondary|Frequency and Types of Neurotoxicity Observed|Frequency and types of neurotoxicity observed among those children treated with l-glutamic acid hydrochloride as compared to those who are in the placebo control group|10 weeks||||||
152074|NCT00369564|Primary|Neurotoxicity as Measured by a Scored Neurologic Examination at Baseline, 5 Weeks, and 10 Weeks (if Applicable)|A neurological exam will be completed at baseline and at study week 5 for both strata. An additional exam at week 10 will be done for patients in Stratum 1. Additional exams will be done at any time if the treating oncologist deems it clinically necessary . Neurotoxicity will be scored using a standardized neurological exam form developed for the study that is based on the Modified “Balis” Pediatric Scale of Peripheral Neuropathies. Treatment groups will be compared with respect to the proportion experiencing a grade 2 or higher toxicity from the following list of neurologic toxicities captured on the Neurologic Exam Form including sensory neuropathy, motor neuropathy, laryngeal nerve, constipation/neuro-constipation, jaw pain, or other specified abnormalities noted by the attending physician. Percentage of patients with one or more Grade 2 or higher noted neurotoxicity symptoms on any item in the Balis scale will compared between arms.|10 weeks|Patients reporting baseline and post-baseline observation||percentage of participants||95% Confidence Interval|Number
152075|NCT00369512|Primary|Number of Patients With Recurrence at 2 Years|Rate of recurrence at 2 years.|2 years|||participants|||Number
152076|NCT00369512|Primary|Median Time to Cancer Recurrence|Median time to cancer recurrence|2 years|Per protocol, patients were followed every 3 months for recurrent disease by physical exam and imaging (MRI/CT). Recurrence, in most cases, is detected during routine history/physical exam. If disease was detected during follow-up, every attempt was made to obtain pathological confirmation of recurrence. Range 1-14 months, median time 10.5 months.||months||Full Range|Median
152077|NCT00369512|Primary|Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments.|Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events|2 years|||number of adverse events|||Number
152126|NCT00369278|Primary|Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment|Median time to first occurrence of treatment failure was not reached in this study.|6 months||||||
152189|NCT00368550|Secondary|Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.|12-week treatment period|||days||Standard Deviation|Mean
152078|NCT00369486|Secondary|Central Subfield Thickness <250 Microns From Baseline Through 34 Weeks|Primary criterion for retreatment is central subfield thickness >=250 microns. Central subfield thickness of <250 microns indicates no need for retreatment. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit||eyes|||Number
152079|NCT00369486|Secondary|Reduction of ≥ 50% in Retinal Thickening in the Central Subfield From Baseline Through 34 Weeks|Number of eyes that had a reduction in central subfield retinal thickness by ≥ 50% at each follow-up. Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology.|4, 8, 17, 34 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit||eyes|Participants||Number
152080|NCT00369486|Primary|Mean Visual Acuity Letter Score at Each Follow-up Visit|Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) mean visual acuity letter score: best value = 97; letter score worst value = 0|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.||letter score|Participants|Standard Deviation|Mean
152081|NCT00369486|Primary|Change in Visual Acuity Letter Score From Baseline Through 34 Weeks|Change in visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant. Negative changes represent a worsening in visual acuity.|4, 8, 17, and 34 weeks|The primary analysis included all randomized eyes and followed the intent-to-treat analysis. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.||letter score|Participants|Standard Deviation|Mean
152082|NCT00369486|Secondary|Persistence/Recurrence of Diabetic Macular Edema (DME) Either Retreated or Meeting Criteria for Retreatment at 17 Weeks|Number of eyes that were retreated at 17 weeks. According to the protocol, primary criterion for retreatment was central subfield thickness >=250 microns or macular edema was still present according to the investigator's judgment.|17 weeks|The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit||eyes|Participants||Number
152083|NCT00369486|Primary|Change in Central Subfield Thickening From Baseline Through 34 Weeks|Change in Central Subfield Thickening from Baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. Negative changes represent a decrease in retinal thickening.|4, 8, 17, 34 weeks|Last Observation Carried Forward was used. The correlation between eyes of patients who have two study eyes (one eye in the laser group and one eye in either of the Triamcinolone groups) was accounted for in the primary analysis. Primary analyses excluded patients who missed the visit.||microns|Participants|Standard Deviation|Mean
152084|NCT00369382|Secondary|Number of Participants in Sirolimus Treatment Group Requiring Conversion Back to CNI Therapy||Baseline up to Week 52|Safety population.||Participants|||Number
152085|NCT00369382|Secondary|Number of Participants Requiring Antibody Use in Treatment of Acute Rejection|Number of participants requiring antilymphocyte antibody therapy with suspected or biopsy-proven, steroid-resistant, acute rejection with or without hemodynamic compromise. Acute rejection based on ISHLT 1990 criteria: all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; N=participants who had biopsy-confirmed acute rejection.||Participants|||Number
152086|NCT00369382|Secondary|Time to First Acute Rejection|Time from baseline to first biopsy-confirmed acute rejection defined as any of the following (based on ISHLT 1990 criteria): all rejections Grade 3A or higher, any rejection accompanied by hemodynamic compromise, or any rejection requiring treatment. ISHLT Grade 3A or higher included: Multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis.|Baseline to Week 52|Safety population; not analyzed because actual start date of rejection was unknown for those diagnosed by site protocol (SOC) biopsy and protocol-required biopsy.||Weeks|||Number
152087|NCT00369382|Secondary|Number of Participants With Biopsy-confirmed Acute Rejection by Severity|Severity of acute rejection summarized using revised 2005 ISHLT criteria. Grade 0R: no rejection, Grade 1R: Focal (perivascular or interstitial) infiltrate without necrosis, diffuse but sparse infiltrate without necrosis, or one focus only with aggressive infiltration and/or focal myocyte damage, Grade 2R:Multifocal aggressive infiltrates and/or myocyte damage, and Grade 3R:Diffuse inflammatory process with necrosis, or diffuse aggressive polymorphous with necrosis, increased infiltrate, changes in edema, hemorrhage and vasculitis.|Baseline to Week 52|Safety population||Participants|||Number
152088|NCT00369382|Secondary|Number of Participants With Acute Rejection|Based on International Society for Heart and Lung Transplantation [ISHLT] 1990 criteria: rejections Grade 3A or higher, rejection accompanied by hemodynamic compromise or requiring treatment. Grade 3A or higher included: multifocal aggressive infiltrates and/or myocyte damage, diffuse inflammatory process with necrosis, diffuse aggressive polymorphus with necrosis, increased infiltrates, and changes in edema, hemorrhage, or vasculitis. Biopsies performed for clinically suspected rejection (for cause), site’s standard of care (site protocol biopsy), or protocol mandated.|Baseline to Week 52|Safety population; n=number of participants analyzed for the specified type of biopsy.||Participants|||Number
152089|NCT00369382|Secondary|Overall Survival (OS)|Survival time from the start of study treatment to date of death due to any cause, censored at the last visit if no death. Death was determined from the Death report. The distribution of time to death was to be estimated using Kaplan-Meier method and compared between treatment groups with a proportional hazard model. The number and percent of survival at 6 and 12 months were to be reported.|Baseline until death (up to Week 56)|Safety population: all randomized participants who received at least 1 dose of study medication; not analyzed by Kaplan-Meier because number of events limited to 2 deaths in the sirolimus group.||Weeks|||Number
152090|NCT00369382|Secondary|Annual Change in Calculated Creatinine Clearance (Cockcroft-Gault Equation)|The change in creatinine clearance over time assessed using the random coefficient slope of the regression line with creatinine clearance as the dependent variable and study day as the independent variable. Time points calculated as study days, relative to time of randomization of study medication. Observed data multiplied by a scale factor of 365 to express an annual change.|Baseline to discontinuation (up to Week 52)|ITT; N=participants with all measurements required for calculated creatinine clearance. All observed data up to the point of discontinuation of the study were used.||mL/min/1.73m^2||95% Confidence Interval|Number
152091|NCT00369382|Secondary|Serum Creatinine Level at Baseline|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine.|Baseline|ITT.||mcmol/L||Standard Deviation|Mean
152092|NCT00369382|Secondary|Change From Baseline in Serum Creatinine Level at 4, 16, 24, 32, 40, and 52 Weeks Post-randomization|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week x minus baseline level where higher scores represented decreased kidney function. Least squares mean adjusted for treatment group and center.|Baseline and Weeks 4, 16, 24, 32, 40, and 52|ITT, All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.||mcmol/L||Standard Error|Least Squares Mean
152093|NCT00369382|Secondary|Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at Baseline|Creatinine clearance calculated using MDRD equation. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT.||mL/min/1.73m^2||Standard Deviation|Mean
152094|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Modification of Diet in Renal Disease [MDRD] Equation) at 4, 16, 24, 32, 40 and 52 Weeks Post-randomization|Creatinine clearance calculated using MDRD equation. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function. Least squares mean adjusted for baseline calculated creatinine clearance (MDRD) and center.|Baseline and Weeks 4, 16, 24, 32, 40 and 52|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study.||mL/min/1.73m^2||Standard Error|Least Squares Mean
152095|NCT00369382|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 4, 16, 24, 32, and 40 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Weeks 4, 16, 24, 32, and 40|ITT; All available data (on-therapy and off-therapy) were included; LOCF for data points missing due to skipped visits or participant withdrawal from study; N=participants with all measurements required for calculated creatinine clearance.||mL/min/1.73m^2||Standard Error|Least Squares Mean
152096|NCT00369382|Primary|Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline|Creatinine clearance at baseline calculated using Cockcroft-Gault equation and adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is ≥ 90 mL/min/1.73m^2.|Baseline|ITT; N=participants with all measurements required for calculated creatinine clearance.||mL/min/1.73m^2||Standard Deviation|Mean
152097|NCT00369382|Primary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization|Creatinine Clearance (CC) calculated using Cockcroft-Gault equation, adjusted for body surface area. Calculated CC: method to approximate kidney function. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (≥) 90 milliliters per minute per 1.73 meters squared (mL/min/1.73m^2). Change from baseline=CC at Week 52 minus CC at baseline where higher scores represented improved renal function; Least squares mean adjusted for baseline calculated creatinine clearance and center.|Baseline and Week 52|Intent-to-Treat (ITT) Population: all randomized participants; all available data (on-therapy and off-therapy) included; Last observation carried forward (LOCF) for data missing due to skipped visits or participant withdrawal from study. Number of participants analyzed (N)=those with all measurements required for calculated creatinine clearance.||mL/min/1.73m^2||Standard Error|Least Squares Mean
152098|NCT00369343|Secondary|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of “new symptoms” and “old (but worse) symptoms” (1) and 0 for “old and unchanged symptom,” “absent,” or “old symptom but improved” for a total possible range of 0 to 43. A higher score indicates more symptoms.|6 months|Open-label (OL) safety population: Patients completed double-blind and continued in OL with ≥1 dose study drug. Excluded patients lost to follow-up and discontinued with <4 wks therapy. Patients analyzed varied by time (0mg, 100mg, 200mg): Early Termination (n=9,98,207); Taper week 1 (n=4,76,193); Taper week 2 (n=5,75,195); Post-taper (n=5,71,192)||units on scale||Standard Deviation|Mean
152099|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Open Label Baseline to 6 Months|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||units on scale||Standard Deviation|Mean
152100|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Open Label Baseline to 6 Months|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= Final Evaluation mean HAM-A score minus baseline mean score.|open label baseline to 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||units on scale||Standard Deviation|Mean
152101|NCT00369343|Secondary|Percentage of Patients Achieving a Response to Treatment|A responder is defined as a patient with ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression - 17-item (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||percentage of patients responding|||Number
152102|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50.|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||percentage of patients|||Number
152103|NCT00369343|Secondary|Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse)|6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase.||units on scale||Standard Deviation|Mean
152104|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Open Label Baseline to 6 Months|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total s core of 50. Change= Final Evaluation mean HAM-D17 minus baseline mean HAM-D17.|open label baseline and 6 months|Open-label phase safety population: All patients who completed the double-blind phase, elected to continue treatment in the open-label phase, and received at least 1 dose of study drug in the open-label phase. One patient did not have a baseline and at least 1 on therapy assessment.||units on scale||Standard Deviation|Mean
152105|NCT00369343|Secondary|Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8|EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation.||units on scale||Standard Error|Mean
152106|NCT00369343|Secondary|Change in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A) Score From Baseline to Week 8|The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A score minus baseline adjusted mean score.|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.||units on scale||Standard Error|Mean
152107|NCT00369343|Secondary|Percentage of Patients Achieving Response to Treatment|A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).||percentage of patients|||Number
152108|NCT00369343|Secondary|Percentage of Patients Achieving Remission|Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50.|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).||percentage of patients|||Number
152109|NCT00369343|Secondary|Percentage of Patients With Each Clinical Global Impression Improvement (CGI-I) Score|CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient’s illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).|8 weeks|Double-blind phase, modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Missing data handled by last observation carried forward (LOCF).||percentage of patients|||Number
152110|NCT00369343|Primary|Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8.|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2-4 scale (0=none/absent and 4=most severe) with a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17|Baseline to 8 weeks|Double-blind phase; modified intent to treat population, which included all randomized patients with a baseline HAM-D17 score ≥18, who took ≥1 dose of study drug and had ≥1 post-baseline HAM-D17 evaluation. Mixed model repeated measures (MMRM) modeling included all available observed data for each patient and no missing values were imputed.||units on scale||Standard Error|Mean
152111|NCT00369317|Secondary|Gene Expression Profiles by Microarrays|A hierarchical clustering algorithm is used to assemble the genes into a dendrogram or tree structure with branches containing genes with similar patterns of expression. This ordered representation can be graphically displayed with colors that reflect the qualitative and quantitative relationships of the expressed genes.|At baseline and at the time of relapse (if available)||||||
152112|NCT00369317|Secondary|Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program.|Descriptive statistics will be used to summarize pharmacokinetic parameters, such as peak plasma concentration, area under the concentration time curve, and half-life of elimination|Days 1, 2, 8, and 9 of induction II||||||
152113|NCT00369317|Secondary|Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry|Differences in the cumulative incidence of relapse for those with and without MRD will be tested using Gray’s test.|After completion of induction therapy (I, IV) and after completion of intensification therapy||||||
152114|NCT00369317|Secondary|Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis|The prevalence of GATA1 mutations will be estimated as the proportion of patients with phenotype data available determined to have the GATA1 mutations.|At baseline and at the end of therapy (intensification) or disease relapse||||||
152115|NCT00369317|Secondary|Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry|The prevalence of megakaryoblastic subtype (AMkL) phenotype will be estimated as the proportion of patients with phenotype data available determined to have the AMkL phenotype. EFS will be estimated for those with and without AMkL using the approach of Kaplan and Meier. Differences in these estimates will be tested for significance using the log-rank statistic test.|At baseline and at the end of therapy (intensification) or disease relapse||||||
152116|NCT00369317|Secondary|Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||From the beginning of induction therapy to the end of intensification therapy||||||
152117|NCT00369317|Secondary|Induction Remission Rate||End of induction therapy||||||
152118|NCT00369317|Primary|Overall Survival (OS) at 3 Years||Time from study entry to death, assessed at 3 years.|Ineligible patients are excluded from analyses of overall survival and event free survival.||percentage||95% Confidence Interval|Number
152119|NCT00369317|Primary|Event-free Survival (EFS) at 3 Years||Time from study entry to induction failure, relapse, or death assessed at 3 years.|Ineligible patients are excluded from analyses of event free survival and overall survival.||percentage||95% Confidence Interval|Number
152120|NCT00369278|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR)|"The Glomerular Filtration Rate (GFR) was calculated using the following formulas:~Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels.~MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels."|6 months|Intent-to-treat population for whom data was available. End of Study data was imputed using Last Observation Carried Forward (LOCF).||ml/min||Standard Deviation|Mean
152121|NCT00369278|Primary|Number of Participants With Any Treatment Failure|Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.|6 months|||Participants|||Number
152122|NCT00369278|Secondary|Renal Function as Measured by Serum Creatinine||6 months|||mg/dL||Standard Deviation|Mean
152127|NCT00369278|Primary|Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L|Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.|Assessed on day 3, 10, 21, 42, 56 and 84|Pharmacokinetic profiles were performed only in patients involved in Phase I of the study. The pharmacokinetic population consisted of 42 participants.||Days||95% Confidence Interval|Median
152128|NCT00369265|Primary|Percentage of Participants With Improvement or Resolution of Arytenoid Erythema|Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks|6 weeks|No results to report; Study was terminated|||||
152129|NCT00369226|Secondary|Overall Survival and Progression-free Survival.|Progression is defined as disease relapse or disease progression since transplant.|by 1 year after PBSC infusion|||percentage of participants||95% Confidence Interval|Number
152130|NCT00369226|Secondary|Incidence of Chronic Graft Versus Host Disease (Chronic GVHD).|Number of participants with chronic GVHD at 1 year post transplant.|by 1 year after PBSC infusion|||percentage of participants||95% Confidence Interval|Number
152131|NCT00369226|Secondary|Sustained Engraftment Following Transplant.|As measured by median total donor chimerism at day 100.|by day 100 post transplant|Several subjects experienced failure to graft, relapse or death prior to assessment and were removed from analysis.||percentage of participants|||Number
152132|NCT00369226|Primary|Incidence of Grade II-IV Acute Graft Versus Host Disease (GVHD) by Day 100.||by day 100 after peripheral blood stem cell (PBSC) infusion|||percentage of participants||95% Confidence Interval|Number
152133|NCT00369226|Primary|Successful Initial Engraftment by Day 45 Post Peripheral Blood Stem Cell (PBSC) Infusion and Administration of Bortezomib (Velcade), Tacrolimus and Methotrexate|Percentage of participants who did not experience failure to engraft or relapse or death before assessment.|by day 45 post PBSC infusion|||percentage of participants|||Number
152134|NCT00369226|Primary|The Maximally Tolerated Dose (MTD) of Bortezomib (Velcade) That Can be Administered With Tacrolimus and Methotrexate After Mismatched Allogeneic Non-myeloablative Peripheral Blood Stem Cell (PBSC) Transplantation|"The MTD of bortezomib was evaluated at 3 dose levels:~Dose level 1: 1.0 mg/m^2 Dose level 2: 1.3 mg/m^2 Dose level 3: 1.5 mg/m^2 Cohorts of 3-5 pts were enrolled at each dose level. At any dose level, if no DLT in the first 3, 4, or 5 pts, then dose escalation would occur.~If 3 evaluable pts in cohort, and 1 of 3 experiences DLT then 2 additional pts treated at the same dose level. If >=1 of 2 additional pts experience DLT then previous dose level will be MTD. If no DLT in additional 2 pts then dose escalation will occur. If 4 evaluable pts in cohort, and 1 of the 4 experiences DLT then 1 additional pt treated at same dose level. If this additional pt experiences DLT then the previous dose will be declared to be the MTD. If additional pt does not experience DLT, then dose escalation will take place. If 5 evaluable pts in cohort, and 1 experiences DLT, then dose escalation will take place. If >=2 of first 3, 4, or 5 pts experience DLT then the previous dose will be declared MTD."|by day 45 post PBSC infusion|||mg/m^2|||Number
152135|NCT00369161|Secondary|Percentage of Participants With Efficacy Failure|Efficacy failure was a composite of BPAR, graft loss, death or lost to follow-up. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy. An allograft was presumed to be lost on the day a patient started dialysis and was unable to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss.|Month 12|Intention to treat (ITT) population.||percentage of participants|||Number
152136|NCT00369161|Secondary|Number of Participants With Incidence of Biopsy-proven Acute Rejection (BPAR)|Biopsy-proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy (performed by the local pathologist). For all clinically suspected rejection episodes a graft core biopsy must have been performed before or within a 24 hour period from the initiation of anti-rejection therapy.|from Month 4 through to Month 12|Intention to treat (ITT) population.||participants|||Number
152137|NCT00369161|Primary|Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR)|"Renal function was assessed by calculated glomerular filtration rate (cGFR) using Modification of Diet in Renal Disease (MDRD)formula.~GFR [mL/min/1.73m^2] = 186.3*(C-1.154)*(A-0.203)*G*R, where:~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|12 months post -transplant|Modified Intent-to-treat (ITT) population i.e patients with an available cGFR at month 12.||mL/min/1.73m^2||Standard Deviation|Mean
152138|NCT00369122|Secondary|Overall Survival (Failure: Death Due to Any Cause)|Estimated using the Kaplan-Meier method.|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for two years.||||||
152139|NCT00369122|Secondary|Disease-free Survival (Failure: Local, Regional or Distant Failure, or Death Due to Any Cause)|Estimated using the Kaplan-Meier method.|From registration to date of failure (any tumor recurrence, development of distant metastases, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
152140|NCT00369122|Secondary|Treatment-related SAEs and AEs as Assessed by CTCAE v. 3.0 Criteria at Any Time.||From start of treatment to end of follow-up||||||
152141|NCT00369122|Primary|Subjects With Treatment-related Serious Adverse Events (SAEs) and Adverse Events (AEs) as Assessed by CTCAE v. 3.0 Criteria Within the First 90 Days From Treatment Start.|Treatment-related SAEs defined as Grade (Gr) >= 4 vaginal bleeding, Gr >=4 thrombotic event, Gr >=3 arterial event, gastrointestinal (GI) bleeding , or bowel/bladder perforation, and any Gr 5 treatment-related AE. Treatment-related AEs defined as all SAEs, Gr 3-4 nausea, vomiting, or diarrhea persisting for >2 weeks depsite medical intervention, Gr 4 neutropenia or leukopenia persisiting for >7 days, febrile neutropenia defined as a temperature >38.5 degree Celsius and granulocytes < 1000/mm3, Grade 3-4 hematologic toxicity with the exception of neutropenia and leukopenia, and Grade 3-4 GI, renal, cardiac, pulmonary, hepatic, or neurologic AEs. Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate >=20% and AE rate >=55% excessive. If there were >=6 pts with SAES or >=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.|From start of treatment to 90 days.|Eligible patients who began study treatment.||participants|||Number
152142|NCT00368992|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses per RECIST in the subset of patients with at least one target lesion assessed by CT or MRI. A complete response (CR) was defined as disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a >= 30% decrease in the sum of the longest diameters of all target lesions. A CR or PR was confirmed if documented a second time at least 4 weeks after the first documentation.|Every 6 weeks while on protocol treatment, up to 3 years.|Eligible patients who received protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
152143|NCT00368992|Secondary|Overall Survival|From date of enrollment to date of death due to any cause. Patients last known to be alive were censored at date of last contact.|Once a week, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.||months||95% Confidence Interval|Median
152144|NCT00368992|Secondary|Progression-Free Survival|From data of registration to date of disease progression (as defined by RECIST, i.e. a 20% increase in the sum of the longest diameters of target lesions, or unequivocal progression ina non-target lesion in the opinion of the treating investigator, or the appearance of new lesions), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|Every 6 weeks until disease progression. After 9 months, every 12 weeks until disease progression, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.||Months||95% Confidence Interval|Median
152145|NCT00368992|Primary|The Percentage of Patients With Grade 4 (i.e. Life-threatening) Hemorrhage Toxicities Related to Protocol Treatment.|All patients who received protocol treatment were assessed for adverse events per the NCI Common Terminology Criteria for Adverse Events, Version 3.0. We counted the number of patients who reported at least one Grade 4 (i.e. life-threatening) hemorrhage adverse event that was possibly, probably, or definitely related to the study treatment.|Every week until removed from protocol therapy, up to 3 years.|Eligible patients who received protocol treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
152146|NCT00368979|Secondary|Number of Participants With Qmax Improvement From Baseline at Week 52|Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||participants|||Number
152147|NCT00368979|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52|Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||milliliters per second (mL/sec)||Standard Deviation|Mean
152148|NCT00368979|Secondary|Number of Participants With IPSS Improvement From Baseline at Week 52|Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||participants|||Number
152149|NCT00368979|Secondary|Percent Change From Baseline in Prostate Volume at Week 52|Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||cubic centimeters (cc)||Standard Deviation|Mean
152150|NCT00368979|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52|The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.|Baseline and Week 52|The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.||score on a scale||Standard Deviation|Mean
152151|NCT00368966|Primary|Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
152152|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
152190|NCT00368550|Primary|Number of Days on Which Subjects Drank|Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.|12-week treatment period|All randomized subjects with missing days imputed as drinking days.||days||Standard Deviation|Mean
152153|NCT00368966|Primary|Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
152154|NCT00368966|Primary|Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose||One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
152155|NCT00368966|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose|Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.|One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
152156|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||μg/mL||95% Confidence Interval|Geometric Mean
152157|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
152158|NCT00368966|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
152159|NCT00368966|Primary|Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
152160|NCT00368966|Primary|Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series||One month after 2-doses of the infant series (5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
152161|NCT00368966|Primary|Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series|Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.|One month after 2-doses of the infant series (5 months of age)|Evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
152162|NCT00368927|Secondary|Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention|The number of dysplastic lesions was recorded pre-intervention and post-intervention for each participant in each group. Change in the number of lesions was compared between the two intervention groups.|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post- intervention bronchoscopy.||Percent change in number of DL||Full Range|Median
152175|NCT00368745|Secondary|Time to First Use of Rescue Medication|The 25th percentile estimate of time until first use of rescue medication is based on Kaplan-Meier estimates. Event day is the study day when the subject first used rescue medication. Rescue medication: packet with 2 doses alprazolam to take only in the event subject experiences severe symptoms of benzodiazepine withdrawal or rebound anxiety.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF||days|||Number
152163|NCT00368927|Primary|Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment|Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease|Baseline and 6 months|The population used for the analysis is patients completing both the pre- and post-intervention bronchoscopy.||percentage of participants|||Number
152164|NCT00368875|Secondary|Overall Survival(OS)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|Time from first treatment day until death, assessed up to 12 months|54 patients in the phase I and phase II portion were evaluated||months||95% Confidence Interval|Median
152165|NCT00368875|Secondary|Time to Treatment Failure (TTF)|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae. Time to treatment failure was not reported for this study.|Time from the first treatment day until disease progression or discontinuation of treatment due to toxicity, assessed up to 12 months|Zero participants analyzed because time to treatment failure was not assessed.|||||
152166|NCT00368875|Secondary|Progression-free Survival (PFS),|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood’s formulae.|From first treatment day until objective or symptomatic progression, assessed up to 12 months|53 patients in the phase I and phase II portions were evaluated||months||95% Confidence Interval|Median
152167|NCT00368875|Primary|Objective Response Rate (CR + PR)|Estimated and a 95% confidence interval will be estimated via binomial proportions. Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions and assessed by CT scan: Complete response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 12 months|53 patients in the phase I and phase II portions were evaluated. One patient was not eligible to be evaluated for objective response rate.||percentage of participants||95% Confidence Interval|Number
152168|NCT00368875|Primary|Recommended Phase II Dose as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I)|Dose-limiting toxcities (DLT) were defined as grade 3-4 febrile neutropenia, thrombocytopenia and non-hemtological toxicity attributed to therapy (nausea, vomiting and diarrhea would be considered dose limiting only if not adequately controlled with therapy). Any toxicity occurring during cycle 1 that resulted in dose reduction of vorinostat or paclitaxel or failure to complete all protocol specificed doses in the first cycle was also considered a DLT|28 days|Three patients were treated at the first vorinostat dose level of 200 mg BID and three additional patients were treated at the second dose level of 300 mg BID||mg|||Number
152169|NCT00368849|Secondary|Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score|Although changes in motor symptoms were not hypothesized, the Unified Huntington Disease Rating Scale motor examination was administered at every visit. An experienced motor rater completes a motor examination and rates the participant on several motor tasks. Total score ranges from 0 - 124, with higher scores indicating a worse outcome. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||units on a scale||Standard Error|Mean
152170|NCT00368849|Secondary|Symptom Checklist-90-Revised (SCL-90-R)|Psychiatric symptoms were evaluated with the Symptom Checklist-90-Revised, a self report measure of psychiatric symptoms. The measure produces raw scores and normed scores (T scores Mean = 50), with higher values representing greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||units on a scale||Standard Error|Mean
152171|NCT00368849|Primary|Executive Composite Score|The executive composite comprises performance on Trail Making Test Part B, Stroop Color and Word Test, and the Controlled Oral Word Association Test (i.e., Verbal Fluency). The composite score is the average combined z score for each test. Positive values indicate better than average performance and negative values worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||units on a scale||Standard Error|Mean
152172|NCT00368849|Primary|Attention Composite Score|The attention composite comprises performance on Wechsler Adult Intelligence Scale III Symbol-Digit and Letter Number Sequencing Subtests, Trail Making Test Part A, computerized simple-choice reaction time, and computerized working memory (i.e., 2-Back). The composite score is the average combined z score for each test. Higher, positive values indicate better than average performance and negative and lower values indicate worse than average. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers.||Units on a scale||Standard Error|Mean
152173|NCT00368849|Primary|Conners' Adult Attention Rating Scale (CAARS)|The Conners' Adult Attention Rating Scale (CAARS) is one of the most frequently used self-rating measures for adult Attention Deficit Hyperactivity Disorder (ADHD) and was given as a self-report measure of attention. It has 66 items with each item ranging from 0 to 3 points. Higher total scores represent greater impairment. The outcome reported was change in score from baseline for each treatment arm.|There are two time points for this measure: baseline and after 4 weeks of treatment|Analysis was based on number of completers||units on a scale||Standard Error|Mean
152174|NCT00368745|Secondary|Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6)|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine toxicology assay (each visit Alprazolam Free phase), negative urine alcohol assay (Alprazolam Free Week 6 = endpoint or LOCF). Relapse: > = 2 intakes rescue medication, positive urine and /or alcohol assays, unable to tolerate alprazolam taper, or discontinuation.|Alprazolam Free Week 6|ITT; endpoint = AF Week 6 or LOCF.||participants|||Number
152176|NCT00368745|Secondary|Time to Discontinuation|The 25th percentile estimate of time until discontinuation is based on Kaplan-Meier estimates. Event day is the study day when the subject discontinued from study.|Baseline, Week 13 (Final Visit/Early Termination)|ITT; Week 13 (Final Visit/Early Termination) or LOCF.||days|||Number
152177|NCT00368745|Secondary|Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores|DSST: subject-rated; evaluates aspects of cognition (includes attending to directions, processing speed, sustained attention, visual-motor integration, learning and psychomotor speed). Subject matches symbol (1 to 9) with corresponding number key (1 to 9); number of correct symbol-number pairs completed by subject over a 90-second test period determines DSST score. Change: mean at observation minus mean at baseline. Data summarized as change from baseline to endpoint.|Baseline, Endpoint (AF Week 6 )|ITT; subject has baseline and endpoint (final visit) measurement; endpoint = AF Week 6 or LOCF.||scores on scale||Standard Error|Least Squares Mean
152178|NCT00368745|Secondary|Mean Scores for Patient Global Impression-Improvement (PGI-I)|PGI-I: subject rated 7-point scale measures change in overall status; range 1 (very much improved) to 7 (very much worse).|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
152179|NCT00368745|Secondary|Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I: 7-point scale to assess global change in subject condition compared to baseline; range 1 (very much improved) to 7 (very much worse); higher score = more affected.|Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
152180|NCT00368745|Secondary|Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores.|CGI-S: 7-point scale to assess global change in subject condition compared to baseline; range 1 (no evidence of illness) to 7 (among the most severely ill); higher score = more affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )|ITT; subject has a baseline and at least 1 post-baseline endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
152181|NCT00368745|Secondary|Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores.||scores on scale||Standard Deviation|Mean
152182|NCT00368745|Post-Hoc|Mean Scores Physician's Withdrawal Checklist (PWC)|Mean scores at each visit for PWC: 20-item physician-rated interview measures presence of anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception, and cognition); range 0 (not present) to 3 (severe). Total score: 0 to 60; higher score = more affected. Mean scores entered as post-hoc analysis as Mean change from baseline in PWS scores not analyzed: PWS not measured at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6 )|ITT; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. Endpoint = AF Week 6 or LOCF. Refer to measure Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores.||scores on scale||Standard Error|Least Squares Mean
152183|NCT00368745|Secondary|Number of Subjects With > = 5 New PWC Symptoms|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.||particpants|||Number
152184|NCT00368745|Secondary|Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores|PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline.|Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)|ITT; data not analyzed: PWC not measured at baseline.||particpants|||Number
152185|NCT00368745|Secondary|Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); lower score indicates less affected. Change from baseline: mean at observation minus mean at baseline.|Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6)|ITT; subject has a baseline and at least 1 post-baseline measurement before week 13; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
152186|NCT00368745|Primary|Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free|Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine benzodiazepine psychoactive toxicology assay (each visit Alprazolam Free phase); negative serum benzodiazepine alcohol assay (endpoint or LOCF).|Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1)|Intent to Treat (ITT) population: received at least 1 dose pregabalin or placebo. Primary outcome ITT = all treated subjects in alprazolam free phase. Endpoint = Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1.||participants|||Number
152187|NCT00368641|Primary|All-cause Hospitalization (Unadjusted)|All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.|6 to 24 months|intent to treat population||hospitalizations per year||95% Confidence Interval|Mean
152188|NCT00368550|Secondary|Change in the Level of Alcohol-related Problems|Measured using the SIP (Short Inventory of Problems), which was administered at pretreatment and at the end of treatment. The range of scores on the SIP is 0 (no alcohol-related problems) to 45 (most severe alcohol-related problems) and the time frame for reporting is the preceding 3 months. The data presented here represent a difference score of treatment minus baseline.|12-week treatment period compared with baseline value|||Units on a scale||Standard Deviation|Mean
152191|NCT00368537|Secondary|Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients|Healthcare resource utilization assessment included intensive care unit (ICU) and non-ICU inpatient hospitalization. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study article.||participants|||Number
152192|NCT00368537|Secondary|Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate|In vitro activity of the study drugs against a range of pathogenic bacteria that cause complicated skin and skin structure infection (cSSSI) were analyzed using MIC. MIC 50 and MIC 90 are the lowest concentrations of a drug that inhibit the growth of 50% and 90% of a microorganism, respectively. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|"m-mITT: Patients with ≥1 dose of study drug, had cSSSI and baseline isolate from infection site / blood. MIC reported for isolates present in ≥10 m-mITT patients. In the categories below n is the actual number of isolates used to caluculate the MIC 50 and MIC 90."||mcg/mL|||Number
152193|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at patient level. Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for patients with a clinical response of failure; Superinfection=culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|up to 6 weeks|Microbiologically Evaluable patients:CE patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). TOC performed 8-50 days after last dose of study drug.||participants|||Number
152194|NCT00368537|Secondary|Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. ME population were subjects who were CE and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. TOC performed 8-50 days after last dose of study drug.|up to 6 weeks|Microbiologically Evaluable patients:Clinically Evaluable (CE) patients who had baseline culture with ≥1 identified pathogen susceptible to both study drugs (ie, the pathogen is susceptible to tigecycline and comparator). Excludes indeterminates.||participants|||Number
152195|NCT00368537|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit|Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.|up to 6 weeks|Clinically Evaluable (CE): Patients with cSSSI, no Pseudomonas aeruginosa as sole baseline isolate, met major inclusion/exclusion criteria, ≤24 hrs antibiotics pre-baseline, had ≥4 days of study drug, compliant with therapy. Excludes indeterminates.||participants|||Number
152196|NCT00368472|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.|Baseline up to week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.||Percent responders|||Number
152197|NCT00368472|Secondary|Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.|Baseline up to Week 221|The analysis was based on the Full Intent to Treat (ITT) Analysis Set, defined as participants who received at least 1 dose of open-label perampanel and had valid seizure data during the OLE study.||Percent Change||Full Range|Median
152217|NCT00368277|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12||Baseline and Week 12|Intent to treat (ITT), Last Observation Carried forward (LOCF)||mm Hg||Standard Error|Least Squares Mean
152218|NCT00368251|Secondary|Global Evaluation Score (Investigator) at the End of Treatment Period|The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).|End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.||percentage of participants|||Number
152229|NCT00368069|Secondary|50% Response in Weekly POS Frequency|A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period.|Treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period)||Participants|||Number
152198|NCT00368472|Primary|Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years|Safety Analysis Set was defined as participants who received at least 1 dose of open-label perampanel and had at least 1 safety assessment after the first dose of perampanel in the OLE study.||Participants|||Number
152199|NCT00368459|Secondary|Cognition (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 6 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
152200|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 6 months, compared between groups. Range 0-120. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
152201|NCT00368459|Secondary|Function, Activities of Daily Living|Change from baseline at 6 months, compared between groups. Range 0-78. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
152202|NCT00368459|Secondary|Clinical Dementia Rating, Sum of Boxes|Change from baseline at 6 months, compared between groups. Range 0-5. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
152203|NCT00368459|Secondary|ADAS-cog|Change from baseline at 6 months, compared between groups. Error score range 0-70. For results below, positive change represents improvement/ better performance.|6 months|||units on a scale||Standard Deviation|Mean
152204|NCT00368459|Secondary|Cognitive (Neuropsychological)|Global composite calculated as a weighted average of standardized scores of neuropsychological tests (weighted by the inverse intertest correlation matrix), change from baseline at 12 months. There is no theoretical maximum or minimum for this cognitive composite, with a score of 0 standardized units representing no change. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
152205|NCT00368459|Secondary|Behavior|Neuropsychiatric Inventory, change from baseline at 12 months. Range 0-120. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
152206|NCT00368459|Secondary|Function, Activities of Daily Living (ADL)|ADL scale from the Alzheimer's Disease Cooperative Study, change from baseline at 12 months. Range 0-78. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
152207|NCT00368459|Secondary|Global Rating, Clinical Dementia Rating (CDR) Sum of Boxes|Global rating of dementia severity, change from baseline at 12 months. Range 0-5. For results below, positive change represents improvement/ better performance.|12 months|||units on a scale||Standard Deviation|Mean
152208|NCT00368459|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)|"ADAS-cog, change from baseline at 12 months, compared between treatment arms. The ADAS-cog is a neuropsychological battery commonly used in trials of AD patients. Error score range 0-70. For results below, positive change represents improvement/ better performance.~For the primary outcome, as well as for secondary outcomes, the reported p-values reflect the calculated p-values."|12 months|Intent-to-treat||units on a scale||Standard Deviation|Mean
152209|NCT00368316|Secondary|Percentage of Efficacy|Percent efficacy is defined as ((disease rate of controls minus disease rate of vaccinees) divided by disease rate of controls) times 100|During 2 years post vaccination|||Percent efficacy||95% Confidence Interval|Mean
152210|NCT00368316|Secondary|Geometric Mean Immunoglobulin G (IgG) Anti-Lipopolysaccharide (LPS) Levels|Age-related homologous IgG anti-LPS levels|Injections were administered 6 weeks apart and IgG anti-LPS levels determined >2 weeks after second vaccine dose. Each of the 15 sites also took a sample/week randomly chosen, for 2 years of follow up and blood samples from patients with disease|||ELISA units||95% Confidence Interval|Geometric Mean
152211|NCT00368316|Primary|Number of Participants With Adverse Events|Number of participants with events per vaccine type and dose occuring in >=5% of participants|Monitored for 7 days per participant following each injection for initial group of 500, 2 days for extended study of up to 5500 additional children|||participants|||Number
152212|NCT00368290|Primary|Cocaine Use as Measured by Urine Drug Screen|The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.|8 weeks|||Percentage of Participants|||Number
152213|NCT00368290|Primary|Percent of Participants Reporting no Cocaine Craving|Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.|8 weeks|||Percent of participants|||Number
152214|NCT00368277|Secondary|Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36||Baseline and week 36|Intent to treat (ITT), Last Observation Carried forward (LOCF)||mm Hg||Standard Error|Least Squares Mean
152215|NCT00368277|Secondary|Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints|Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg|Weeks 12 and 36|intent to treat (ITT), last observation carried forward (LOCF)||Percentage of participants|||Number
152216|NCT00368277|Secondary|Percentage of Patients With Cough||Weeks 12 and 36|Safety population||Percentage of Participants|||Number
152219|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)|The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.||Percent change||Full Range|Median
152220|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)|The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.||Percent change||Full Range|Median
152221|NCT00368251|Secondary|Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)|The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.||Percent change||Full Range|Median
152222|NCT00368251|Primary|Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)|The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.|From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)|The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.||Percent change||Full Range|Median
152223|NCT00368108|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population||Hours||95% Confidence Interval|Least Squares Mean
152224|NCT00368108|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population||Scores on a Scale||95% Confidence Interval|Least Squares Mean
152225|NCT00368108|Secondary|Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)|Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 20|ITT Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
152226|NCT00368108|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)|"Patients described themselves in home diaries as OFF, ON without dyskinesias, ON with non troublesome dyskinesias, ON with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor."|Baseline and Week 20|The Intent-to-treat (ITT) Population for diary data consisted of all subjects who were randomized to either perampanel or placebo, had taken at least 1 dose, had a valid, nonmissing Baseline diary measurement and at least 1 valid, non-missing, postbaseline diary measurement at Last Observation Carried Forward (LOCF).||Hours||95% Confidence Interval|Least Squares Mean
152227|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population|Number of POS over the treatment period standardized to 1 week period|Treatment Period (12 weeks)|Per Protocol (PP) Population (Analyses were performed on subjects from the PP Population with non-missing information during both baseline and treatment period)||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
152228|NCT00368069|Secondary|Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks|The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration.|over the treatment period (12 weeks)|ITT Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the periods (baseline or treatment period).||Participants|||Number
152230|NCT00368069|Secondary|All (Type I+II+III) Seizures Frequency Per Week|Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures)|Treatment period (12 weeks)|ITT (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
152231|NCT00368069|Secondary|POS Seizure Frequency Per Week Over Baseline and Treatment Period||Baseline Period (8 weeks) - Treatment Period (12 weeks)|ITT Population - no imputation techniques used for missing data (number of subjects with non-missing data for Baseline = ITT Population and for Treatment period = 75 patients for Levetiractam and 78 patients for PBO) Clusters of type I count are included in the count of Type I seizures||seizures per week||Inter-Quartile Range|Median
152232|NCT00368069|Primary|Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population|Number of POS over the treatment period standardized to 1 week period.|Treatment period (12 weeks)|Intention-to-treat (ITT) (Analyses were performed on subjects from the ITT with non-missing information during baseline and treatment period.)||seizures per week (log-transformed data)||Standard Error|Least Squares Mean
152233|NCT00367991|Secondary|Circulating Endothelial Progenitor Cells||Day 3 and Day 10||||||
152234|NCT00367991|Secondary|Serum Markers of Myocyte Damage and Apoptosis||Day 1 and Day 10||||||
152235|NCT00367991|Secondary|Left Ventricular Ejection Fraction||Day 1 and Day 10||||||
152236|NCT00367991|Primary|Platelet Function Assay Closure Time||Day 3 and Day 10||||||
152237|NCT00367991|Primary|Bleeding Time|An integrated measure of in vivo platelet function and tissue hemostasis|Day 3 and Day 10|ITT||seconds||Inter-Quartile Range|Median
152238|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|One month after the 3-Dose Infant Series (at 5 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
152239|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
152240|NCT00366678|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
152241|NCT00366678|Primary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the 3-Dose Infant Series (at 5 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Geometric Mean
152242|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||EU/mL||95% Confidence Interval|Number
152243|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Number
152244|NCT00366678|Primary|Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Number
152245|NCT00366678|Primary|Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group||One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||IU/mL||95% Confidence Interval|Geometric Mean
152246|NCT00366678|Secondary|Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose|GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||titer||95% Confidence Interval|Geometric Mean
152247|NCT00366678|Secondary|Percentage of Participants Achieving Antibody Titer ≥1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
152248|NCT00366678|Secondary|Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
152249|NCT00366678|Secondary|Percentage of Participants Achieving a Pneumococcal Antibody Level ≥0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups|Percentages of participants achieving World health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (at 13 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||percentage of participants||95% Confidence Interval|Number
152250|NCT00366678|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group|Percentage of participants achieving predefined antibody threshold levels ≥0.1 IU/mL for diphtheria, ≥0.1 IU/mL for tetanus, ≥ 0.15 μg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer ≥1:8 for polio and ≥5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.|One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)|The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
152251|NCT00366626|Primary|Limited Access Alcohol Consumption Paradigm; Total Number of Drinks Consumed|Subjects were allowed to drink up to 8 alcohol drinks during 2 hours observation period being in bar/laboratory settings vs to get $2 per each not consumed drink.|On day 7 of treatment during limited access alcohol consuption in the bar/laboratory|All subjects who were randomized.||Total number of drinks consumed||Standard Deviation|Mean
152252|NCT00366626|Primary|"Natural Alcohol Consumption Period; Average Number of Drinks Per Day Consumed During the 5 Day Natural (Usual Environment) Drinking Observation Period"||treatment days 1 - 5|All subjects who were randomized.||Drinks per day||Standard Deviation|Mean
152253|NCT00367835|Secondary|Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population||mmHg||Standard Deviation|Mean
152254|NCT00367835|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population||mmHg||Standard Deviation|Mean
152255|NCT00367835|Secondary|Change From Baseline in Pulse Rate at Up to 8 Weeks||Baseline and up to 8 weeks|Safety population||beats/min||Standard Deviation|Mean
152256|NCT00367835|Secondary|Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Baseline and up to 8 weeks|Safety population defined as all randomized subjects who received at least one dose of any investigational product during this study.||msec||Standard Deviation|Mean
152257|NCT00367835|Secondary|Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)|"The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of strongly agree or agree."|up to 8 weeks|FAS||Participants|||Number
152258|NCT00367835|Secondary|Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks|The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
152259|NCT00367835|Secondary|Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks|Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.|Baseline and up to 8 weeks|FAS||units on a scale||Standard Deviation|Mean
152260|NCT00367835|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS||Participants|||Number
152262|NCT00367835|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|FAS||Units on a scale||Standard Deviation|Mean
152263|NCT00367835|Primary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of any investigational product during this study and with a baseline and at least one post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
152264|NCT00367770|Primary|Number of Participants With a Change in WHO Functional Class|"Number of participants with a change in WHO functional class from baseline to week 24.~A change from a higher to a lower functional class (i.e. III to II, III to I or II to I) is considered as an improvement."|from baseline to week 24|The analysis was done in the safety set.||participants|||Number
152265|NCT00367770|Primary|Change in Borg Dyspnea Index|Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.|from baseline to week 24|The analysis was done in the safety set.||units on a scale||Standard Deviation|Mean
152266|NCT00367770|Primary|Change in 6-minute Walk Distance||from baseline to week 24|The analysis was done in the safety set.||m||Standard Deviation|Mean
152267|NCT00367744|Secondary|the Change in the Carotid IMT of the Common Carotid Artery|Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was available||mm||Inter-Quartile Range|Median
152268|NCT00367744|Primary|Change in Limb Fat at 48 Weeks|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|48 weeks|Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble.||grams||Inter-Quartile Range|Median
152269|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Proteins|Baseline and post-therapy plasma samples were obtained from participants. Immunohistochemistry analyses were carried out using a BioPlex 200 machine (Bio-Rad) or by enzyme-linked immunoassays to evaluate levels of angiogenesis-related proteins and other relevant proteins. Post- and pre-treatment changes in cytokines and angiogenic factors in response to pazopanib were analyzed. A negative value indicates that the post-treatment level of the particular target protein was less than the pre-treatment level.|Baseline to at least two weeks and at most 6 weeks|Safety population: all participants who received at least one dose of pazopanib. Only 33 of 35 subjects had plasma samples from both pre- and post-treatment available for analysis.||ratio||Inter-Quartile Range|Median
152270|NCT00367679|Secondary|Semiquantitative Levels of Staining in Pre-treatment Tumor Biopsies (e.g. VEGF, VEGFR-1,VEGFR-2).|Analysis not performed as part of study. Appropriate material was not available for analysis.|Entire study interval|Safety Population: all participants who received at least one dose of pazopanib||Relative luminescence units||Standard Deviation|Mean
152271|NCT00367679|Secondary|Genetic Variations in Germline DNA|Plasma samples were collected from each consenting participant, generally at baseline, to permit evaluation of the presence or absence of genetic variations in select candidate genes in germline DNA. Analyses that could have been done might have examined the relationship between genetic variants and the safety or tolerability or the efficacy of pazopanib. Analyses have not yet been conducted, but a need to do so may yet be identified. The clinical study report indicated that results, if any, would be reported separately.|Baseline|Safety Population: all participants who received at least one dose of pazopanib||Sum of changes in gene (DNA) sequences||Standard Deviation|Mean
152272|NCT00367679|Secondary|Plasma Levels of Lactate Dehydrogenase-5 (LDH5)|LDH5 has been shown to be associated with activation of angiogenesis in lung cancer. Circulating levels of LDH5 were to have been measured at each scheduled visit through the post-treatment visit to determine if a correlation with drug effect existed. Levels of LDH5 were measured, but the team determined that greater value was to be derived from transcriptional and plasma biomarker analyses; thus, no analyses were conducted to examine the correlation of LDH5 levels with effects of pazopanib.|Baseline to at least three weeks and at most 8 weeks|Safety Population: all participants who received at least one dose of pazopanib||Units/Liter||Standard Deviation|Mean
152273|NCT00367679|Secondary|Intratumoral Levels of Specific Biomarkers|A pre-treatment tumor biopsy from each participant was to have been analyzed by Western blotting to semi-quantitate levels of various proteins related to angiogenesis and/or to the mechanism of action of pazopanib. These assays were not carried out due to insufficient quantity of tissue present in the pre-treatment biopsy (fine needle aspirate). The clinical study report indicates that results were to have been reported separately.|Baseline tumor biopsy|Safety Population: all participants who received at least one dose of pazopanib||nanograms/milliliter||Standard Deviation|Mean
152274|NCT00367679|Secondary|Gene Mutations in Pre- or Post-treatment Tumor Biopsies|Specific genes (KRAS, MYC, TP53, and others) were to have been analyzed for the presence or absence of amplifications or deletions and for the presence, absence, and sequence of point mutations in pre- or post-treatment tumor biopsies. These analyses were not conducted because the potential results were considered to provide overlapping information with those obtained in the transcriptional and proteomic profiling assays that were conducted. The clinical study report indicates that genetic measures were to have been reported separately.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Safety Population: all participants who received at least one dose of pazopanib||Number of DNA sequence changes||Standard Deviation|Mean
152311|NCT00367133|Secondary|Central Subfield Thickness < 250 Microns at 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.||Percentage of Eyes|||Number
152275|NCT00367679|Secondary|Ratio of Post- to Pretreatment Expression Levels for Each of the Indicated Pazopanib Target Genes|Gene expression data analysis was performed with GeneSpring GX 7.3.1 (Agilent Technologies). Data were preprocessed using the RMA algorithm. The Benjamini and Hochberg false discovery rate was used for multiple testing corrections. Data below are log-transformed ratios of the post-treatment to pre-treatment expression intensity, indicating the fold increase/decrease in expression of genes. PDGF, platelet-derived growth factor; VEGFR, vascular endothelial growth factor receptor; c-KIT, a protein tyrosine kinase that is a receptor for stem cell factor or “kit” ligand.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tumor tissue from Safety Population: all participants who received at least one dose of pazopanib. Only 26 of 35 subjects had sufficient tissue in both pre- and post-treatment samples for analysis.||ratio||Standard Deviation|Median
152276|NCT00367679|Secondary|Number of Cells Exhibiting Apoptosis in Participant Samples|Tumor cells from pre-treatment and post-operative biopsies were to have been analyzed to determine the number of cells that were exhibiting apoptosis. Due to the limited quantity of tissue in pre- and post-treatment biopsy samples, these assays were not performed.|Baseline to at least three weeks and at most 8 weeks (surgery date)|Tissue from Safety Population: all participants who received at least one dose of pazopanib||number of cells||Standard Deviation|Mean
152277|NCT00367679|Secondary|Number of Participants With the Indicated Change From Baseline in Systolic and Diastolic Blood Pressure|Increases in systolic or diastolic blood pressure values at any point in the study following baseline were summarized. mmHg = millimeters of mercury. Baseline blood pressure values as well as the change from baseline experienced are given in the category titles.|Baseline to at least three weeks and at most 8 weeks|Safety Population||participants|||Number
152278|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Chemistry Values|Shifts in chemistry values by grade were summarized based on the NIH Common Terminology Criteria for Adverse Events (Version 3.0 – definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here. ULN = upper limit of normal; Gr = grade; mg = milligrams; dL = deciliter; mmol = millimoles.|Baseline to at least three weeks and at most 8 weeks|Safety Population||participants|||Number
152279|NCT00367679|Secondary|Number of Participants With Shifts From Baseline to Grade 2 or Greater in Hematology Values|Shifts in hematology values by grade were summarized based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (Version 3.0 – definitions provided with each parameter below). Shifts to Grade 2 or greater at any point in the study following baseline are reported here.|Baseline to at least three weeks and at most 8 weeks|Safety Population||participants|||Number
152280|NCT00367679|Secondary|Number of Participants Achieving a >=60% Reduction in Tumor Metabolic Activity Determined as Standard Uptake Value (SUV)|Response is the number of participants whose tumor demonstrated a 60% or greater reduction in metabolic activity (SUV) as measured by positron emission tomography (PET) or PET/computed tomography (PET/CT) at the end of treatment visit relative to baseline. This analysis was not conducted because insufficient data were collected: only three participants had PET/CT data.|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib||participants|||Number
152281|NCT00367679|Secondary|Number of Participants Achieving a Clinical Response Based on RECIST|Response is the number of participants achieving either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes not meeting previously given criteria. Confirmation requires at least 2 assessments (conducted by a central reviewer) of CR/PR with at least 4 weeks between the assessments.|Baseline to at least two weeks or at most six weeks|Safety population: all participants who received at least one dose of pazopanib||participants|||Number
152282|NCT00367679|Primary|Number of Participants Achieving Tumor Shrinkage Based on Change in Tumor Volume|"Tumor shrinkage was assessed as the change in tumor volume using high-resolution computed tomography scans of the thorax following treatment with pazopanib. Response is defined as the number of participants achieving at least 50% tumor volume reduction following pazopanib treatment. Responder is a participant whose tumor volume reduced at least 50% following pazopanib treatment. Non-responder is a participant whose tumor volume did not reduce at least 50% following treatment. Tumor assessments were conducted by a central reviewer."|Baseline to at least two weeks or at most six weeks|Safety Population: all participants who received at least one dose of pazopanib||participants|||Number
152283|NCT00367640|Primary|Average Rhinoconjunctivitis Total Symptom Score|"Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment.~Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome."|Pollen period (average of 32 days in the ITT set)|The intent-to-treat (ITT) population included all patients who received at least one dose of investigational product and had a Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS) and at least one Rhinoconjunctivitis Total Symptom Score (RTSS) in the pollen period while on treatment.||Units on a scale (range: 0 to 18)||Standard Deviation|Mean
152284|NCT00367601|Secondary|Overall Survival||12 months|||months||95% Confidence Interval|Median
152285|NCT00367601|Secondary|Time to Progression||12 months|||months||95% Confidence Interval|Median
152286|NCT00367601|Primary|To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician||4 months|||percentage of participants|||Number
152287|NCT00367484|Primary|Number of Participants Testing Positive for Neutralising Antibody (NAb)|Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.|48 Weeks|Intent To Treat (ITT) population, Last Observation Carried Forward (LOCF)||NAb+ participants|||Number
152372|NCT00366301|Primary|Percentage Reduction in C-reactive Protein (CRP)||14 weeks|As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. Any subject having either or both 6 week and 14 week measures was included.||Percent CRP Reduction||95% Confidence Interval|Mean
152288|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B):~[ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Other types of Seizures are all seizures except Partial Seizures (Type 1)."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Other Types of Seizures.||Percent Reduction||Inter-Quartile Range|Median
152289|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A):~[ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple and Complex Partial Seizures.||Percent Reduction||Inter-Quartile Range|Median
152290|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in secondary generalized seizure frequency is given as a percent reduction computed as:~[ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100.~Positive values in reduction means the value decreased from Baseline during the first 16-week Period.~Secondary generalized seizures belong to one of the 3 groups:~Simple partial sz evolving to gen sz~Complex partial sz evolving to gen sz~Simple partial sz evolving to Complex partial sz evolving to gen sz"|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Secondary Generalized Seizures.||Percent Reduction||Inter-Quartile Range|Median
152291|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in complex partial seizure frequency is given as a percent reduction computed as:~[ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Complex Partial Seizures.||Percent Reduction||Inter-Quartile Range|Median
152292|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study|"Change in simple partial seizure frequency is given as a percent reduction computed as:~[ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Subset of the FAS population excluding subjects with seizure counts equal to zero during Baseline and Evaluation Period for Simple Partial Seizures.||Percent Reduction||Inter-Quartile Range|Median
152293|NCT00367432|Secondary|Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)|"The percent reduction from Baseline was computed as:~[ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100.~Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).||Participants|||Number
152294|NCT00367432|Secondary|Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)|Full Analysis Set (FAS).||Seizures Per Week||Inter-Quartile Range|Median
152295|NCT00367432|Secondary|Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study|"The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as:~[ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100.~Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period.~Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures."|Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study|Full Analysis Set (FAS).||Percent Reduction||Inter-Quartile Range|Median
152296|NCT00367432|Primary|Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)|"An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product.~Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE."|During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted|Safety Set includes all subjects from N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once.||participants|||Number
152297|NCT00367380|Primary|Infection for P. Vivax|Thick blood smear was performed to patients daily on days 7 to 23, and every other day until day 29. Any prove of P. vivax infection was considered positive and confirmed later by real time polymerase chain reaction (rPCR).|Twenty eight days|||days||Standard Deviation|Mean
152298|NCT00367341|Secondary|Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks|Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score|Measured at week 12.|completers||participants|||Number
152299|NCT00367341|Primary|Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks|# of study participants with Hamilton Depression-17-item score less than or equal to 7.|Measured at week 12|completed study participants in 12-week-trial||participants|||Number
152300|NCT00367237|Secondary|Adverse Events|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16||||||
152301|NCT00367237|Secondary|Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16||||||
152302|NCT00367237|Secondary|Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|between baseline and week 16||||||
152303|NCT00367237|Primary|Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16|>=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.|between baseline and week 16|Number of subjects from Intent-to-Treat population in each arm at Week 16||participants|||Number
152304|NCT00367133|Secondary|Percentage of Eyes With a Change in Central Subfield Thickness on OCT <250 Microns From Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Percentage of Eyes|||Number
152305|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Microns||Inter-Quartile Range|Median
152306|NCT00367133|Secondary|Change in Central Subfield Thickness on OCT Baseline to 3 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Microns||Standard Deviation|Mean
152307|NCT00367133|Secondary|Central Subfield Thickness on Optical Coherence Tomography (OCT) at Three Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Microns||Inter-Quartile Range|Median
152308|NCT00367133|Secondary|Distribution of Visual Acuity Change Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale=97, worst=0|Baseline to 3 years|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Percentage of Eyes|||Number
152309|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best Value on the scale=97, Worst Value=0|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Letter Score||Inter-Quartile Range|Median
152310|NCT00367133|Secondary|Change in Visual Acuity From Baseline to 3 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 3 year|The study discontinued early. Only subjects with 3 years data are included in 3 year analysis.||Letter Score||Standard Deviation|Mean
152312|NCT00367133|Secondary|Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|Baseline to 2 Years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.||Percentage of Eyes|||Number
152313|NCT00367133|Secondary|Median Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes an improvement.|Baseline to 2 Years|Only subjects with an available OCT's at baseline and 2 years are included in the OCT analysis.||Microns||Inter-Quartile Range|Median
152314|NCT00367133|Secondary|Mean Change in Central Subfield Thickness Baseline to 2 Years|Overall central subfield change from baseline. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. The average of 2 baseline central subfield thickness measurements was used for analysis.If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield. Negative change denotes and improvement.|Baseline to 2 years|Only subjects with available OCTs at baseline and 2 years are included in the OCT analysis.||Microns||Standard Deviation|Mean
152315|NCT00367133|Primary|Distribution of Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|baseline to 2 years|The primary analysis included all randomized eyes and followed the intent-to-treat principle||Percentage of Eyes|||Number
152316|NCT00367133|Primary|Median Change in Visual Acuity Baseline to 2 Years|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.||Letter score||Inter-Quartile Range|Median
152317|NCT00367133|Secondary|Central Subfield Thickness at 2 Years|Median central subfield thickness at two-years. Optical coherence Tomography (OCT) images were obtained by a certified operator using the Zeiss Stratus OCT machine. If the automated thickness measurements were judged by the reading center to be inaccurate, center point thickness was measured manually, and this value was used to impute a value for the central subfield.|2 Years|Only subjects with an available Optical coherence tomography (OCT) at baseline and 2 years are included in the OCT analysis.||Microns||Inter-Quartile Range|Median
152318|NCT00367133|Primary|Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.|Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 2 Years|The primary analysis included all randomized eyes and followed the intent-to-treat principle.||Letter score||Standard Deviation|Mean
152319|NCT00367055|Secondary|Mean Change From Baseline in Insulin Sensitivity Index at Months 18 and 36|Change from baseline was calculated as the Month 18 and 36 values minus the baseline value. Insulin sensitivity is measured as the quantity of glucose metabolized per unit of plasma insulin concentration.|Baseline and Months 18 and 36|ITT Population||micromoles (umol)/kilogram/min/pmol/L||Standard Deviation|Mean
152320|NCT00367055|Secondary|Mean Change From Baseline in CPP Concentration Peak and Incremental Concentration Peak T0-T30 After a 36-month Treatment||Baseline and Month 36||||||
152321|NCT00367055|Secondary|Mean Change From Baseline in CPP Total and Incremental AUC T0-T30 After a 36-month Treatment||Baseline and Month 36||||||
152322|NCT00367055|Secondary|Median Change From Baseline in Beta Cell Function Index (HOMA-beta) After a 36-month Treatment||Baseline and Month 36||||||
152323|NCT00367055|Secondary|Median Change From Baseline in Insulin Resistance Index (HOMA-IR) After a 36-month Treatment||Baseline and Month 36||||||
152324|NCT00367055|Secondary|Mean Change From Baseline in FBG at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. FBG levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.||millimoles per Liter (mmol/L)||Standard Deviation|Mean
152325|NCT00367055|Secondary|Mean Change From Baseline in HbA1c at Month 36|Change from baseline was calculated as the Month 36 value minus the baseline value. HbA1c levels were measured by blood draw.|Baseline and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug and had an available efficacy evaluation (hyperglycaemic clamp at M18 or M36). This measurement was conducted on participants in the ITT Population who had baseline and M18 and M36 clamp test data available.||percent change||Standard Deviation|Mean
152326|NCT00367055|Secondary|Median Change From Baseline in the Insulin Secretion Capacity After an 18-month Treatment|Change from baseline was calculated as the Month 18 value minus the baseline value. Insulin secretion capacity is measured in blood (blood level of insulin) and is a response of the pancreatic beta-cells to hyperglycemia induced by a glucose IV bolus, then infusion. Hyperglycemic clamp (HC) is a reference technique to evaluate the initial and the secondary phases of insulin secretion.|Baseline and Month 18|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."||pmol/L*min||Full Range|Median
152327|NCT00367055|Secondary|Median Change From Baseline in the Ratio M/I After a 36-month Treatment||Baseline and Month 36||||||
152328|NCT00367055|Primary|Median Change From Baseline in the Insulin Secretory Capacity After a 36-month Treatment|Change from baseline in the insulin secretory capacity was measured by the assesment of blood insulin concentrations (conc.) using the hyperglycaemic clamp (HC) technique, per intravenous glucose perfusion by a catheter. Change from baseline for insulin conc peaks (highest conc level) was calculated as the Month 36 value minus the baseline value. Insulin secretion was assessed by calculating AUC during the first 10 minutes of HC (incremental and total AUC0-10 min) and the AUC after the first 10 minutes of the HC (10-180min).|Baseline and Month 36|"Intent-to-Treat (ITT) Population: participants receiving at least one dose of study drug with an available efficacy evaluation (HC at M18 or M36). The measurement was conducted on participants who had baseline and M18 and M36 HC test data available. Each HC was validated at both Baseline and Month 36, resulting in different ns for each category."||picomoles/L per minute (pmol/L*min)||Full Range|Median
152329|NCT00366899|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
152330|NCT00366899|Secondary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose|Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the toddler dose (12 months of age)|Evaluable pneumococcal immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
152331|NCT00366899|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
152332|NCT00366899|Primary|Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose|Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)|The evaluable pneumococcal immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||percentage of participants||95% Confidence Interval|Number
152333|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Polio as measured using a polio in vitro plaque neutralization.|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||Titers||95% Confidence Interval|Geometric Mean
152334|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.||IU/mL||95% Confidence Interval|Geometric Mean
152335|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
152336|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose|GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.|One month after the infant series (6 months of age) and the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.||mIU/mL||95% Confidence Interval|Number
152337|NCT00366899|Other Pre-specified|Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after infant series dose 2 and after the toddler dose|OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group||Titers||95% Confidence Interval|Geometric Mean
152338|NCT00366899|Other Pre-specified|Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose|Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).|one month after infant series dose 2 and after the toddler dose|OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group||% Achieving OPA Titer ≥1:8||95% Confidence Interval|Geometric Mean
152339|NCT00366899|Primary|Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose|GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)|one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||EU/mL||95% Confidence Interval|Geometric Mean
152340|NCT00366899|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose|Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.|One month after the infant series (6 months of age) and after the toddler dose (12 months of age)|Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant antibody concentration/titer for the given concomitant antigen.||percentage of participants||95% Confidence Interval|Number
152341|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
152342|NCT00366899|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|During the 4-day period after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
152343|NCT00366548|Secondary|Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
152344|NCT00366548|Primary|Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series|GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
152345|NCT00366548|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
152346|NCT00366548|Other Pre-specified|Percent of Participants Reporting Pre-Specified Local Reactions|Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 4-days after each dose|The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.||Percentage of Participants|||Number
152373|NCT00366275|Primary|Progression-free Survival|"PFS is calculated according to the Kaplan-Meier estimator. The observation time of each subject is defined as the time from entry into the study until lymphoma progression or death as a result of any cause whichever occurs first.~The 5-year PFS is the estimated cumulative probability of surviving at least 5 years without progression."|every 3 months for the first year after autotransplant and every 6 months after the first year of follow up|||percent chance of PFS at 5 years||95% Confidence Interval|Number
152347|NCT00366548|Secondary|Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the toddler dose (at 13 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
152348|NCT00366548|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series|Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (at 5 months of age)|Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
152349|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 3|Day 3 data reflect the use of rescue medication only up to the time of discharge|Day 3|||participants|||Number
152350|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 2||Day 2|||participants|||Number
152351|NCT00366444|Secondary|Number of Patients Who Required Rescue Medication on Day 1||Day 1|||participants|||Number
152352|NCT00366444|Secondary|Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|"Number of participants analyzed includes only the number of participants with at least a 30% reduction in pain intensity after the 1st dose (see previous outcome measure, #7).~Number of placebo patients is intentionally blank as the data (eg., upper CI) was not calculable."||minutes||95% Confidence Interval|Median
152353|NCT00366444|Secondary|Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug||8 hours post single dose|||participants|||Number
152354|NCT00366444|Secondary|Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug|Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.|8 hours post single dose|||units on a scale||Standard Deviation|Mean
152355|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1||8 hours post single dose|"Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure, #4).~Number of patients in the placebo group is intentionally blank as the data was not calculable since less than 50% of the patients reported meaningful relief (ie, median cannot be calculated)."||minutes||95% Confidence Interval|Median
152356|NCT00366444|Secondary|Number of Patients With Meaningful Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
152357|NCT00366444|Secondary|Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1||8 hours post single dose|Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous Outcome Measure #2)||minutes||95% Confidence Interval|Median
152358|NCT00366444|Secondary|Number of Patients With Perceptible Pain Relief on Day 1|Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.|8 hours post single dose|||participants|||Number
152359|NCT00366444|Primary|Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy|Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain|Over 48 hours after bunionectomy|||units on a scale||Standard Deviation|Mean
152360|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
152361|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, participants who received given dose; (n)= number of participants reporting yes for at least 1 day or no for all days.||percentage of participants|||Number
152362|NCT00366340|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Day 1 through 4 after each dose|Safety population, included participants who received given dose; (n) = number of participants reporting the specific characteristic.||percentage of participants|||Number
152374|NCT00366249|Secondary|Number of Patients With Microbiologic Response of Eradication.|Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Microbiologically evaluable population without osteomyelitis.||patients|||Number
154254|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
152363|NCT00366340|Primary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 months of age) and one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
152364|NCT00366340|Primary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||mIU/mL||95% Confidence Interval|Geometric Mean
152365|NCT00366340|Primary|Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||IU/mL||95% Confidence Interval|Geometric Mean
152366|NCT00366340|Primary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose||One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant antigen.||μg/mL||95% Confidence Interval|Geometric Mean
152367|NCT00366340|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose|Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).|One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a antibody concentration ≥ the prespecified level for the given concomitant antigen.||Percentage of Participants||95% Confidence Interval|Number
152368|NCT00366340|Primary|Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
152369|NCT00366340|Primary|Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.|Percentage of Participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series OPA antibody titer to the given serotype.||Percentage of Participants||95% Confidence Interval|Number
152370|NCT00366340|Primary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||μg/mL||95% Confidence Interval|Geometric Mean
152371|NCT00366340|Primary|Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|One month after 3-dose infant series (5 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.||Percentage of Participants||95% Confidence Interval|Number
152424|NCT00365846|Secondary|Incidence of Malignancies|Number of Participants Experiencing Malignancies|3 years|||participants|||Number
152375|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinical modified intent to treat population with osteomyelitis.||patients|||Number
152376|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinical modified intent to treat population without osteomyelitis.||patients|||Number
152377|NCT00366249|Secondary|Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.|Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose|Clinically evaluable population with osteomyelitis.||patients|||Number
152378|NCT00366249|Primary|Number of Patients With Clinical Response of Cure Vs. Failure.|Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.|Test of cure visit (TOC): Assessed at least 12 days post last dose|Clinically evaluable population without osteomyelitis.||patients|||Number
152379|NCT00366106|Secondary|Relative Dose Intensity of Bortezomib|Relative dose intensity is defined as actual dose/scheduled dose. Bortezomib is administered on Days 1, 4, 15, and 18 every 28 days.|Each dose of bortezomib (days 1, 4, 15, and 18 every 28 days)|Note that the sample sized varied at each dose and ranged from 32 patients to 1 patient.||Relative dose intensity||Standard Deviation|Mean
152380|NCT00366106|Secondary|Number of Participants With Treatment Response|Complete Response (CR), Partial Response (PR), and Minor Response (MR) each required stable bone disease and normal calcium levels. CR also required 100% serum protein electrophoresis (SPEP) reduction, negative immunofixation (IF), 100% urine protein electrophoresis (UPEP)reduction, and <5% plasma cells in bone marrow. PR also required >=50% SPEP reduction, >=90% UPEP reduction, and >=50% reduction in plasma cells in bone marrow. MR also required >=25% SPEP reduction, >=50% UPEP reduction, and > 25% reduction in plasma cells.|Every 8 weeks from start of treatment until end of treatment|||Participants|||Number
152381|NCT00366106|Secondary|Time to Progression (TTP)||TTP was measured from day 1 of treatment until time of progression, assessed up to 40 months|||Months||Standard Deviation|Mean
152382|NCT00366106|Primary|Incidence of Treatment-emergent Peripheral Neuropathy||Every 4 weeks from start of treatment until end of treatment|||Participants|||Number
152383|NCT00366028|Primary|Effect Size of Improvement in Hand Hygiene Compliance|The effect size of improvement in hand-hygiene compliance was calculated by comparing the baseline three-month periods to the last three-month periods of the study. To evaluate the statistical significance of changes in proportion adherence over time, we ran a weighted least squares regression model with time (i.e. month) as the independent variable and adherence proportion as the dependent variable. The sample size in each data collection period was used as the weight. Our interest is in the statistical significance of the coefficient associated with time. To evaluate the practical significance of the change pre and post intervention, we examined the effect size associated with the change in proportion adherence in the first 3-month period of data collection and the last 3-month period. Effect size was calculated as 2*arcsin(sqr(p2)) - 2*arcsin(sqr(p1)). Using Cohen's criteria, an effect size of .2 is interpreted as small, .5 as medium and .8 as large.|3 months pre and post study intervention|This outcome measure was only assessed at the site (facility) level.||effect size|Participants||Number
152384|NCT00366028|Primary|Fidelity to the Organizational Model|"Final fidelity to the Organizational Model was assessed by averaging scores for each component of the model. Scores ranged from 0 (no evidence of that factor present) to 4 (factor fully present and used as intended). The 3 main components of the model included 1) active leadership commitment to quality, 2) robust clinical process redesign to incorporate evidence-based practices into routine operations, and 3) use of management structures and processes to support and align redesign. Scores for each component of the model were measured by the study team using structured rating instruments based on data collected during interviews.~Sites with an overall fidelity score above 3.0 were considered to have high fidelity to the organizational model."|Fidelity was assessed at the end of the 3 year study.|This outcome measure was only assessed at the site (facility) level.||units on a scale|Participants||Number
152385|NCT00365976|Secondary|State-Trait Anxiety Inventory (STAI)|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)|Baseline, week 1, week 2, week 4|Data not collected.|||||
152386|NCT00365976|Secondary|Short Form 36 Health Survey Questionnaire (SF-36)|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Baseline, week 1, week 2, week 4|Data not collected.|||||
152387|NCT00365976|Secondary|Hamilton Depression Rating Scale (HAM-D-24)|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4|||units on a scale||Standard Deviation|Mean
152388|NCT00365976|Secondary|Roland Morris Low Back Pain Inventory (RMLBPI)|"The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 “yes-no” items assessing potential disabilities.~Scores range from 0 (no disability) to 24 (severe disability)."|prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4|||units on a scale||Standard Deviation|Mean
152389|NCT00365976|Secondary|Patient Global Impression of Pain Ratings|Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)|postnaprosyn Baseline, Week 1, Week 2 week 4|||units on a scale||Standard Deviation|Mean
152390|NCT00365976|Secondary|Insomnia Severity Index (ISI)|The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0–28: 0–7 (no clinical insomnia), 8–14 (subthreshold insomnia), 15–21 (insomnia of moderate severity), and 22–28 (severe insomnia).|Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4|||units on a scale||Standard Deviation|Mean
152391|NCT00365976|Secondary|Sleep Quality Ratings|Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep|Postnaprosyn Baseline, Week 1, Week 2 week 4|||units on a scale||Standard Deviation|Mean
152392|NCT00365976|Secondary|Number of Awakenings||Postnaprosyn Baseline, Week 1, Week 2 week 4|||awakenings||Standard Deviation|Mean
152393|NCT00365976|Secondary|Wake Time After Sleep Onset||Postnaprosyn Baseline, Week 1, Week 2 week 4|||minutes||Standard Deviation|Mean
152394|NCT00365976|Secondary|Mean Sleep Onset Latency (SOL)||Postnaprosyn Baseline, Week 1, Week 2 week 4|||minutes||Standard Deviation|Mean
152395|NCT00365976|Secondary|Visual Analog Scale Pain Ratings (VAS)|Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain|Postnaprosyn baseline, Week 1, Week 2, Week 4|||units on a scale||Standard Deviation|Mean
152396|NCT00365976|Primary|Mean Subjective Sleep Diary Derived Total Sleep Time (TST)|Nightly total sleep time was averaged from diary entries.|Postnaprosyn baseline, Week 1, week 2, week 4|||Minutes||Standard Deviation|Mean
152397|NCT00365872|Other Pre-specified|Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort|To identify the nodes to be excised, an injection with Indium 111 (radio active dye) labeled dendritic cells (of vaccine #4) was performed 1 to 3 days prior to surgery. Patients were evenly divided to be assigned to one of three cohorts: Cohort 1, 1 day before surgery; Cohort 2, 2 days before surgery; Cohort 3, 3 days before surgery. Vaccine #4 was labeled in order to evaluate how long dendritic cells need to travel to regional draining lymphatics. Tumor resection was not delayed by this.|Up to 3 years|Participants evaluable for this measure||participants|||Number
152398|NCT00365872|Secondary|Participants With No Evidence of Disease at Follow-up|Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years.|3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
152399|NCT00365872|Secondary|Occurrence of Postoperative Wound Complications|Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC).|Up to 3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
152400|NCT00365872|Secondary|Occurrence of Significant (>/= Grade 2) Toxicity|Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
152401|NCT00365872|Primary|Overall Response Rate (ORR)|Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment.|Up to 3 years|All evaluable participants available for follow-up at time of analysis.||participants|||Number
152402|NCT00365859|Secondary|Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Score at Week 52 (Endpoint, LOCF)|CY-BOCS is a 10-item, clinician-rated scale designed to measure the severity of obsessive-compulsive symptoms in patients below the age of 18. The scale contains 5 items pertaining to obsessions (which were not used in this trial) and 5 items pertaining to compulsions, which rated each symptom domain in terms of time spent, interference with functioning, distress, resistance, and control. Each item was rated on a 5-point scale, from 0 (no symptoms or minimum severity) to 4 (extreme symptoms or maximum severity). CY-BOCS Score is from 0 to 20. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 96 patients did not have post-baseline evaluations for CY-BOCS, and were excluded from the efficacy analyses.||units on a scale||Standard Deviation|Mean
152403|NCT00365859|Secondary|Mean Change From Baseline in ABC Inappropriate Speech Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Inappropriate Speech Subscale score is from 1 to 12. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF||units on a scale||Standard Deviation|Mean
152404|NCT00365859|Secondary|Mean Change From Baseline in ABC Social Withdrawal Scale At Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Social Withdrawal Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
152405|NCT00365859|Secondary|Change From Baseline in ABC Stereotypy Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Stereotypy Subscale Score is from 0 to 21. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
152406|NCT00365859|Secondary|Mean Change From Baseline in ABC Hyperactivity Subscale Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Hyperactivity Subscale Score is from 0 to 48. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF.The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
152407|NCT00365859|Secondary|Mean Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Score at Week 52 (Endpoint, LOCF)|The ABC is an informant-based symptom checklist for assessing and classifying problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0 = not at all a problem to 3 = the problem is severe in degree), and resolve into 5 subscales: (1) irritability and agitation; (2) lethargy and social withdrawal; (3) stereotypic behavior; (4) hyperactivity and noncompliance, and (5) inappropriate speech. ABC Irritability Subscale Score is from 0 to 45. A negative change signifies improvement|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations. Of those, 8 patients had baseline ABC (all subscales) evaluations but no post-baseline.||units on a scale||Standard Deviation|Mean
152408|NCT00365859|Secondary|CGI-Improvement Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Improvement (CGI-I) is a clinician rated assessment that evaluates improvement relative to symptoms at baseline on a a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). CGI-I Score is from 1 to 7. A lower score signifies larger improvement.|Week 52 (Endpoint, LOCF)|Efficacy Sample. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.||units on a scale||Standard Deviation|Mean
152409|NCT00365859|Secondary|Mean Change From Baseline in Clinical Global Impression (CGI)-Severity Score at Week 52 (Endpoint, LOCF)|CGI scale is a global evaluation of improvement over time. CGI-Severity (CGI-S) is a clinician-rated assessment that evaluates the severity of a patient's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe symptoms). CGI-Severity score is from 1 to 7. A negative change score signifies improvement.|Week 0 (Baseline), Week 52 (Endpoint, LOCF)|Efficacy Sample, LOCF. The Efficacy Sample includes all patients that had a baseline and at least one post-baseline measurement of the same scale. A total of 322 patients met this criterion based on CGI-S evaluations.||units on a scale||Standard Deviation|Mean
152410|NCT00365859|Primary|Mean Change From Baseline By Time Period in BMI Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The BMI z-scores are designed to take into account the BMI that would be expected due to normal growth in children and adolescents. The BMI z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual BMI measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.||Standard Deviations away from Population||Standard Deviation|Mean
152411|NCT00365859|Primary|Mean Change From Baseline in Patient Body Mass Index (BMI)|The body mass index (BMI) is a statistical measurement which compares a person's weight and height. Though it does not actually measure the percentage of body fat, it is used to estimate a healthy body weight based on subject height.|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample: Endpoint - Last Observation Carried Forward (LOCF)||kg/m2||Standard Deviation|Mean
152412|NCT00365859|Primary|Mean Change From Baseline by Time Period in Body Weight Z-Score|The Z-Score indicates how many standard deviations a person is from the population norm values. The body weight z-scores are designed to take into account the amount of weight gain that would be expected due to normal growth in children and adolescents. The body weight z-scores are by age and gender standardized values (corresponding to a normal distribution with mean 0 and a standard deviation of 1) of the actual weight measurements, based on the Growth Charts provided by the Centers for Disease Control (CDC; see Links section of this record).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample. Subjects included in the period evaluation had a baseline and at least 1 measurement within the time period that was assessed. Patients are only counted once in each time period but can appear in multiple time periods. For those with multiple records in 1 time period, only the last record in that period is included in calculations.||Standard Deviations away from Population||Standard Deviation|Mean
152413|NCT00365859|Primary|Mean Change From Baseline in Patient Weight||At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||kg||Standard Deviation|Mean
152414|NCT00365859|Primary|Number of Potentially Clinically Relevant Vital Sign Abnormalities|Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 & ages 15+; blood pressure cohorts: ages 6-12 & ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg & ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg & ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg & ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg & ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm).|At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint)|Safety Sample||Participants|||Number
152415|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities|"These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = to"|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
152416|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities|Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin >ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
152417|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities|Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males & females) ≤33%; hemoglobin (ages 6-17, males & females) <11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males & females) >17%; neutrophils <15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
152418|NCT00365859|Primary|Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities|Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males)|At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52|Safety Sample||Participants|||Number
152419|NCT00365859|Primary|Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
152420|NCT00365859|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
152421|NCT00365859|Primary|Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Week 8, Week 26, Week 52|Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF)||units on a scale||Standard Deviation|Mean
152422|NCT00365859|Primary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs|Safety Population||Participants|||Number
152423|NCT00365846|Secondary|Kidney Allograft Survival||3 years|||participants|||Number
152431|NCT00365716|Secondary|Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)||Through 36 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at Day 1 and PCR negative through Month 7 to the relevant HPV type, and must provide follow-up data after Month 7||Incidence per 100 person-years|||Number
152432|NCT00365716|Primary|Number of Subjects With Injection Site Adverse Experiences||Days 1-5 following any vaccination visit|All vaccinated subjects with adverse experience follow-up.||Participants|||Number
152433|NCT00365599|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|4 years, 7 months|All participants||participants|||Number
152434|NCT00365599|Secondary|Time to Progression (TTP)|The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 30 months|All participants||months||Full Range|Median
152435|NCT00365599|Primary|Number of Participants With Objective Response (OR)|The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.|24 weeks|All participants||participants|||Number
152436|NCT00365547|Secondary|Median Overall Survival|Defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.|From Day 1 Until Death Occurred|Maximum number of days was 1349.||Days||95% Confidence Interval|Median
152437|NCT00365547|Secondary|Median Duration of Response|Defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to progressive disease. For subjects who do not progress or die, duration of response will be censored at the time of last contact.|Day of 1st Response Until Disease Progression of Death/Last Contact|Maximum number of days was 1277.||Days||95% Confidence Interval|Median
152438|NCT00365547|Secondary|Median Time to Response|Defined as the time from the start of treatment until first documented evidence of at least a partial tumor response.|From Day 1 Until Tumor Response|Maximum number of days for analysis was 104.||Days||95% Confidence Interval|Median
152439|NCT00365547|Secondary|Number of Tumor Responders|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).|From Day 1 Until Disease Progression or Date of Death (Whichever Occurred First), Up to 1 Year|||Participants|||Number
152440|NCT00365547|Primary|Median Time to Disease Progression|Assessed by Response Evaluation Criteria In Solid Tumor (RECIST criteria). Progression is defined as a measureable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions since baseline.|From Day 1 Until First Documented Disease Progression or Date of Death (Whichever Occurred First)|All intent-to-treat patients enrolled were analyzed. Maximum number of days was 1349.||Days||95% Confidence Interval|Mean
152441|NCT00365508|Secondary|Rate of Compliance During the First 2 Weeks|Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence|2 weeks|Intent to treat||participants|||Number
152442|NCT00365508|Primary|24-hour Point Prevalence Abstinence at the 6-month Follow up||6-months|Intent to treat analysis (lost to follow-up = smoker)||participants|||Number
152443|NCT00365456|Primary|Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.|BMD was measured by Dual X-ray Absorptiometry (DXA).|12 months|All randomized patients made the Full Analysis Set which was used for the primary and secondary analyses according to intention-to-treat principles. One participant excluded due to missing baseline data at trial period III entry, thus no data could be carried forward for this patient. Missing values imputed by Last Observation Carried Forward.||Percentage Change||Standard Error|Least Squares Mean
152444|NCT00365417|Secondary|Percentage of Surgical Complications Defined as Wound Dehiscence, Infection, Seroma, Hematoma||Two (2) years||||||
152445|NCT00365417|Secondary|Overall Survival|Time from the first dose of study therapy until date of death|From the first dose of study therapy until the date of death or for a maximum of 24 months from study entry||||||
152446|NCT00365417|Secondary|Progression-free Survival|Time from the first dose of study therapy to disease progression|From the first dose of study therapy until the date of disease progression or for a maximum of 24 months from study entry||||||
152447|NCT00365417|Secondary|Cardiac Events|Events: Congestive Heart Failure; Cardiac Death|Assessments throughout; up to 18 months following study entry||||||
152448|NCT00365417|Secondary|Reported Adverse Events||Assessments throughout; final adverse event assessment is 30 days after the last dose of bevacizumab|||events|||Number
152449|NCT00365417|Secondary|Clinical Response Rate (cRR) of the Sequential Regimen|Measured by physical exam of the breast and axilla|Assessments at baseline, between the two chemotherapy regimens and following the last cycle of chemotherapy (before surgery)||||||
152450|NCT00365417|Secondary|pCR in the Breast and Nodes|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel nodes|Assessed at the time of surgery|||participants|||Number
152451|NCT00365417|Primary|Pathologic Complete Response (pCR) in the Breast|Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen|Assessed at the time of surgery|||participants|||Number
152452|NCT00365391|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal.|All 27 patients were used in this analysis.||months||95% Confidence Interval|Median
154255|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
152453|NCT00365391|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented.|The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|No patients were analyzed for this secondary outcome due to insufficient data.|||||
152454|NCT00365391|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, up to 3 years after treatment.|All 27 patients were included in the analysis.||months||95% Confidence Interval|Median
152455|NCT00365391|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, patients are followed up to 3 years after treatment|All 27 patients were analyzed.||months||95% Confidence Interval|Median
152456|NCT00365391|Primary|Number of Patients With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR).|Responses to erlotinib and bevacizumab treatment were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters.|Patients were able to continue treatment indefinitely and were evaluated every cycle until discontinued treatment.|Four patients were inevaluable because they were off the study prior to first radiologic evaluation for objective response.||participants|||Number
152457|NCT00365378|Primary|Serum Anti-HPV 16 Geometric Mean Titers|"The limit of detection of the assay was 6 mMU/ml. Samples with titer below the limit of detection were assigned a value of 3 for calculation of GMT and confidence interval. GMTs and confidence limits below the limit of detection are shown as 6.0."|Month 7|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide serology data at Month 7||milliMerck units/ml (mMU/ml)||95% Confidence Interval|Geometric Mean
152458|NCT00365378|Primary|Incidence of HPV 16-related CIN1, CIN2 or C1N3|Cases of HPV 16-related CIN1, CIN2 or CIN3 are those with detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1, CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR negative to HPV 16 through Month 7, and must provide follow-up data after Month 7||Incidence per 100 person-years|||Number
152459|NCT00365378|Primary|Incidence of Persistent HPV 16 Infection|Cases of persistent infection were those with detection of HPV 16 by PCR (Polymerase chain reaction) on at least 2 consecutive visits at least 4 months apart; or detection of HPV 16 in a cervical biopsy specimen showing pathologic evidence of CIN1 (Cervical intraepithelial neoplasia), CIN2 or CIN3 together with HPV 16 detected at the visit immediately before or after the biopsy; or detection of HPV 16 on a subject's last visit.|Through Month 48|Per-protocol population: subjects must have no major protocol violations, must be seronegative to HPV 16 at Day 1 and PCR (Polymerase chain reaction) negative to HPV 16 through Month 7, and must provide follow-up data after Month 7||Incidence per 100 person-years|||Number
152460|NCT00365365|Secondary|Disease-free Survival (DFS) Rate|"DFS was defined as the time from the administration of the first-dose of study medication until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. DFS rate was the probability of being disease free and alive at a particular time. DFS rates were estimated using Kaplan-Meier Method, and 95% confidence intervals were computed using the method of Kalbfleisch and Prentice.~For participants who did have objective recurrence of tumor and who were still on study at the time of an analysis, or who were given antitumor treatment other than the study treatment, or who were removed from study follow-up prior to documentation of the tumor recurrence, DFS was censored at the last date the participant was known to be disease-free."|from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months|Intent-to-treat population - All randomized participants||percentage of participants|Participants|95% Confidence Interval|Number
152461|NCT00365365|Secondary|Safety - Number of Participants With Adverse Events (AE)|"An adverse event was any untoward medical occurrence in a participant of the clinical investigation, regardless of the relationship to study treatment.~A serious adverse event (SAE) was an AE that at any dose (including overdose) resulted in death, was life-threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect, and/or was medically important.~Treatment-emergent adverse events (TEAE) were defined as AEs that developed or worsened in severity during the on-treatment period."|from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.|Safety population - participants who received at least one dose of study medication||participants|||Number
152462|NCT00365365|Primary|Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)|"Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy.~Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF."|from the first dose of study medication up to the end of follow-up (up to 3 yrs)|Safety population - participants who received at least one dose of study medication||participants|||Number
152463|NCT00365352|Secondary|Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)|The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom.|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||hours||95% Confidence Interval|Median
152464|NCT00365352|Secondary|Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)|RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM. A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day.|Week 12|MITT Population. The number analyzed represents participants within the MITT Population who reported no RLS symptoms at the end of Week 12.||participants|||Number
152465|NCT00365352|Secondary|Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF|The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants. The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale. It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination).|Baseline and Week 12|MITT Population: The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152466|NCT00365352|Secondary|Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep quantity domain were measured in time (number of hours of sleep each night). The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||hours||Standard Deviation|Mean
152467|NCT00365352|Secondary|Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Basline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152468|NCT00365352|Secondary|Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152469|NCT00365352|Secondary|Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF|"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)."|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152470|NCT00365352|Secondary|Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF|The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated. The possible ratings range from “0” (Not all all) to “4” (Extremely). The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains. Higher scores indicate a more negative mood disturbance. The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination).|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152471|NCT00365352|Secondary|Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF|The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood. Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse). The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination).|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
152472|NCT00365352|Secondary|Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF|"The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week. Participants were asked to rate overall sleep quality (as either Excellent, Reasonable, or Poor), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week."|End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
152473|NCT00365352|Secondary|Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)|The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant’s overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as “Responders.”|Week 1 and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
152474|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF|The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152475|NCT00365352|Secondary|Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF|"The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits A Responder is a participant with a score of much improved or very much improved on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF)."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
152476|NCT00365352|Secondary|Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF|The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined study visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value.|Baseline and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152477|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF|Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Popultion. The number of participants assessed varies due to incomplete/missing data.||minutes||Standard Deviation|Mean
152478|NCT00365352|Secondary|Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF|Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time – lights out time) – time to fall asleep – time awake during the night] in hours. The change was calculated as the end of treatment (Week 12) value minus the Baseline value.|Baseline to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||hours||Standard Deviation|Mean
152479|NCT00365352|Secondary|Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.||responders|||Number
152480|NCT00365352|Secondary|Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Basline and Week 12|Participants included in the MITT Population with a known RLS treatment history||participants|||Number
152481|NCT00365352|Secondary|Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and the End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152482|NCT00365352|Secondary|Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152483|NCT00365352|Secondary|Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152484|NCT00365352|Secondary|The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I|The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method.|Baseline (Day 1) to End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||weeks||95% Confidence Interval|Median
152485|NCT00365352|Secondary|Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of “much improved” or “very much improved.”|End of Week 1|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
152486|NCT00365352|Secondary|Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF|"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders."|Week 12|MITT Population. The number of participants assessed varies due to incomplete/missing data.||participants|||Number
152487|NCT00365352|Secondary|Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF|The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day 1) and End of Treatment (Week 12)|MITT Population. The number of participants assessed varies due to incomplete/missing data.||scores on a scale||Standard Deviation|Mean
152488|NCT00365352|Primary|"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"|"The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being “very much improved,” a score of 2 being much improved, a score of 3 being minimally improved, a score of 4 being no change, a score of 5 being minimally improved,a score of 6 being much worse, and a score of 7 being “very much worse. Participants with a response of much improved or very much improved were classified as responders."|Week 12|MITT Population||participants|||Number
152489|NCT00365352|Primary|Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)|The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline and Week 12|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who also satisfied all of the following conditions: (1) completed the IRLS Rating Scale at Baseline; and (2) completed at least one on-treatment IRLS Rating Scale score during the treatment period||scores on a scale||Standard Deviation|Mean
152490|NCT00365300|Primary|Number of Patients Withdrawn From Study Due to Lack of Efficacy.|Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician’s judgment.|4 weeks double-blind|The analysis population was the Modified Intent to Treat, which included all GERD patients who completed the 4 week open-label treatment phase, were randomized into the 4 week double-blind phase, and took at least one dose of double-blind treatment.||patients|||Number
152491|NCT00365274|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Up to 5 years|||percentage of participants|||Number
152492|NCT00365261|Secondary|Opiate Dosing From Patient Controlled Analgesia|Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.|2 days post dosing|||mg||Inter-Quartile Range|Median
152493|NCT00365261|Primary|Patient Self-report Data on Fatigue|Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue–Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).|2 days post treatment|||scores on a scale||Standard Error|Mean
152494|NCT00365261|Primary|Pain|Pain was assessed with a 10-cm visual analog scale (0 = “no pain at all”; 10 = “severe, uncontrolled pain”).|post dosing|||scores on a scale||Standard Error|Mean
152495|NCT00365209|Secondary|Number of Participants at Each Adverse Event Grade Level||Baseline to 30 days|These participants completed the study. The data is from the final dataset which was available in 2013 following the publication.||participants|||Number
152496|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Plasma Concentrations|Post-treatment curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
152497|NCT00365209|Secondary|Baseline Curcumin Conjugates Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 19 participants in the 4g arm; therefore, 19 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
152498|NCT00365209|Secondary|Post-treatment Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcumin group and 18 participatns from 4g curcumin group). In 2g group, a total of 13 samples with detectable levels were analyzed. In 4g group, a total of 12 samples with detectable levels were analyzed.||µg/g protein|Participants|Standard Deviation|Mean
152499|NCT00365209|Secondary|Baseline Curcumin Conjugates Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 19 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin conjugates in rectal mucosa were found in 0 participants in the 2g arm and 1 participant on the 4g arm. Therefore, 0 samples from the 2g arm and 1 sample from the 4g arm are reported here.||µg/g protein|Participants|Standard Deviation|Mean
152500|NCT00365209|Secondary|Post-treatment Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|At 30 day|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 2 participants in the 4g arm; therefore, 2 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
152501|NCT00365209|Secondary|Baseline Curcumin Plasma Concentrations|Baseline curcumin conjugate concentrations will be measured directly from the subject’s plasma and then the change in concentrations after the last dose of study drug will be measured. Concentrations will be measured and statistically evaluated by paired t-test or Wilcoxon matched-pairs signed-ranks test, as appropriate.|Baseline|Samples from 19 participants in the 4g curcumin arm were assayed. Detectable levels of curcumin in plasma were found in 4 participants in the 4g arm; therefore, 4 samples are reported here. Samples from participants in the 2g curcumin arm were not collected due to a delayed decision resulting with protocol modification and resource restrictions.||µg/mL|Participants|Standard Deviation|Mean
152502|NCT00365209|Secondary|Post-treatment Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|At 30 day|The analysis is based on 39 participants (21 participants from 2g curcmin, and 18 participants from 4 g curcumin). In 2g group, a total of 5 samples with detectable levels were analyzed. In 4g group, a total of 3 samples with detectable levels were analyzed.||µg/g protein|Participants|Standard Deviation|Mean
152503|NCT00365209|Secondary|Baseline Curcumin Concentration in Rectal Mucosa|If detectable in the rectal mucosa, it is predicted that curcumin concentrations and potentially curcumin conjugate concentrations will be associated with reduction in PGE2 and 5-HETE measured from colorectal mucosal biopsies. Pearson correlation coefficients between changes in baseline levels in these 2 parameters and curcumin concentration in rectal mucosa will be calculated. Endpoints may be log transformed as appropriate prior to analysis.|Baseline|Samples from 21 participants in the 2g curcumin arm and 18 participants in the 4g curcumin arm were sent to be assayed. Detectable levels of curcumin in rectal mucosa were found in 1 participant in the 2g arm and none in participants on the 4g arm. Therefore, only 1 sample from the 2g arm and 0 samples from the 4g arm are reported here.||µg/g protein|Participants|Standard Deviation|Mean
152504|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||percentage of labeled cells||Standard Deviation|Mean
152505|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Distal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)||percentage of labeled cells||Standard Deviation|Mean
152506|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||percentage of labeled cells||Standard Deviation|Mean
152507|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Middle Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin : (N = 17 participants).||percentage of labeled cells||Standard Deviation|Mean
152508|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g crucumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||percentage of labeled cells||Standard Deviation|Mean
152509|NCT00365209|Primary|Post-treatment in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Post-treatment prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152510|NCT00365209|Secondary|Proliferation by Ki-67 Immunohistochemical Assay (IHC) in Normal Mucosa - Proximal Third||Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 17 participants)||percentage of labeled cells||Standard Deviation|Mean
152511|NCT00365209|Secondary|Changes in Total Aberrant Crypt Foci (ACF) Number|Changes in total aberrant crypt foci (ACF) number = Number of ACF at pre-treatment - Number of ACF at post-treatment|Baseline to 30 days|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 22 participants), Stage2 4 g curcumin: (N = 19 participants)||Number of ACF||Full Range|Median
152512|NCT00365209|Secondary|Change in Cyclooxygenases (COX-1, COX-2), and Lipoxygenase (5-LOX) Protein Abundance|The protein levels for each enzyme will be expressed as an absolute change from baseline and graphed against % change of its enzyme product in the same individual. The degree of correlation between these parameters will be assessed by either Pearson’s correlation coefficient or Spearman’s rank order correlation coefficient.|Baseline to 30 days|There is not enough tissue for the analysis, so no data is provided.|||||
152513|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152514|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Level in Normal Mucosa|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152515|NCT00365209|Secondary|Post-treatment in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Post-treatment prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|At 30 day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152516|NCT00365209|Secondary|Baseline in Prostaglandin E2 (PGE2) Level in Normal Mucosa|Baseline prostaglandin E2 (PGE2) values found in normal mucosa rectal tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152517|NCT00365209|Secondary|Post-treatment in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Post-treatment 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|At 30 Day|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152518|NCT00365209|Secondary|Baseline in 5-hydroxy-eicosatetraenoic Acid (5-HETE) Within Aberrant Crypt Foci (ACF)|Baseline 5-hydroxy-eicosatetraenoic acid (5-HETE) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants), Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152519|NCT00365209|Primary|Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF)|Baseline prostaglandin E2 (PGE2) values found in rectal aberrant crypt foci (ACF) tissue|Baseline|The analysis is based on participants whose data are evaluable and available. Stage1 2 g curcumin: (N = 21 participants) and Stage2 4 g curcumin: (N = 19 participants)||µg/g protein||Standard Deviation|Mean
152520|NCT00365144|Secondary|Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker||21 weeks||12/2013||||
152521|NCT00365144|Secondary|Time to Tumor Progression|Time to tumor progression (TTP) was defined as the time from initial therapy to the first objective documentation of tumor progression (for patients with measurable disease) or to the data of death, if death was ascribed to progression of disease. Patients initially without measurable disease were included in the analysis based either on the appearance of new measurable lesions or on strongly suggestive radiographic evidence of progression of non-measurable disease). Participants were followed for tumor progression; the longest duration without progression was 132 days.|132 days||12/2013||||
152522|NCT00365144|Secondary|Objective Response as Measured by RECIST Criteria|Participants experiencing objecting response, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|21 weeks|||participants|||Number
152523|NCT00365144|Primary|Safety and Toxicity|Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks)|21 weeks|||participants|||Number
152524|NCT00365144|Primary|Overall Survival Rate at 6 Months|Number of participants alive at 6 months|6 months|All participants were followed for survival||participants|||Number
152525|NCT00365105|Secondary|Utility and Cost Effectiveness of the Use of Radiopharmaceuticals and Bisphosphonates as Measured by the EuroQol-5 Dimension (EQ-5D)||From pre-treatment to 1 year||||||
152530|NCT00365105|Primary|Time to Development of a Malignant Skeletal-related Events (SRE)|Median Time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.|From randomization to date of SRE development|All eligible patients who started study treatment.||months||95% Confidence Interval|Median
152531|NCT00365053|Secondary|Histone Acetylation by IHC and Western Blotting|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline and at 4 hours after last dose of PXD101 on day 5||||||
152532|NCT00365053|Secondary|Apoptosis by TUNEL Assay|Summarized with contingency tables or scatterplots, and with quantitative measures of agreement.|At baseline||||||
152533|NCT00365053|Secondary|Toxicity Profile as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity. Toxicity will be monitored on an ongoing basis according to guidelines based on the sequential probability ratio test.|Up to 3 years||||||
152534|NCT00365053|Secondary|Time to Progression|Estimated using the product-limit method of Kaplan and Meier.|Up to 3 years|||Months||95% Confidence Interval|Mean
152535|NCT00365053|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 3 years|||Months||95% Confidence Interval|Median
152536|NCT00365053|Primary|Objective Tumor Response Rate According to the Response Evaluation Criteria in Solid Tumors (RECIST) Committee|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 3 years|||percentage of participants|||Number
152537|NCT00364286|Primary|Participants With Objective Response|Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: > 50% decrease; Liver/Spleen CR: Not palpable; PR: > 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: >1,500/μl, PR: > 1,500/μl or >50% improvement from baseline; Platelets for CR: >100,000/μl, PR: >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused) for CR: >11,0 g/dl; PR: >11.0 g/dl or >50% improvement from baseline; Lymphocytes for CR: <4,000/μl and PR: >50% decrease; Bone Marrow aspirate for CR: <30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: < 30% lymphocytes with residual disease on biopsy for nodular PR.|4 week treatment cycle|Three participants were not evaluable for response due to early discontinuation of treatment (0-3 days).||Participants|||Number
152538|NCT00364182|Secondary|36-Item Short-Form Health Survey (SF-36): Physical Functioning Domain|SF-36: standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The physical functioning domain score was an average of the individual physical functioning question scores across all time points, which was scaled 0-100 (100=highest level of functioning).|Weeks 16, 32, and 56|ITT; N=number of participants with evaluable data.||units on a scale||Standard Deviation|Mean
152539|NCT00364182|Secondary|HRPQ Score: Hours Lost From Work or School at 48 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|48 hours post-bleed|ITT||hours||Standard Deviation|Mean
152540|NCT00364182|Secondary|Health-Related Productivity Questionnaire (HRPQ) Score: Hours Lost From Work or School at 24 Hours Post-bleed|HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.|24 hours post-bleed|ITT||hours||Standard Deviation|Mean
152541|NCT00364182|Secondary|Acute Pain After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night and included a Brief Pain Inventory (BPI): self-reported scale that measured severity of pain experienced over the past 24 hours. Questions included How much pain right now? 0 (no pain) to 10 (pain as severe as you can imagine).|24 and 48 hours post-bleed|ITT||units on a scale||Standard Deviation|Mean
152542|NCT00364182|Secondary|Quality of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How would you describe the quality of your sleep last night? 1=Very Good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor. Reported as quality of sleep during study.|24 and 48 hours post-bleed|ITT||Units on a scale||Standard Deviation|Mean
152543|NCT00364182|Secondary|Amount of Sleep Measured by Sleep Diary After Hemarthrosis|For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How long do you think you slept last night? Reported as average duration of sleep during study.|24 and 48 hours post-bleed|ITT||hours||Standard Deviation|Mean
152544|NCT00364182|Primary|Annualized Number of Bleeding Episodes|Annualized bleed rate (ABR) or number of bleeds per year derived for each participant for each treatment regimen by using the following formula: ABR = number of bleeds / (days on treatment regimen / 365.25)|Baseline up to Week 56|Intention-to-treat (ITT) population: all enrolled participants||episodes||95% Confidence Interval|Least Squares Mean
152545|NCT00364156|Primary|Biochemically Verified 7-day Point Prevalence Abstinence|To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.|End of Treatment (week 24)|Intention to Treat analysis (ITT)||Participants|||Number
152546|NCT00364949|Primary|Infant Birth Weight (Male and Female)||birth|Birth weight of the male and female infants.||gram||Standard Deviation|Mean
152547|NCT00364949|Primary|Dehydroepiandrosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||ng/ml||Standard Deviation|Mean
152548|NCT00364949|Primary|Dihydrotestosterone Level in Female Offspring||cord blood|The number of participants analyzed only included the levels of the female offspring.||pg/ml||Standard Deviation|Mean
152552|NCT00364949|Primary|Estradiol Level in Female Offspring|The blood that were analyzed were taken from cord blood and not from the offspring.|One time sampling from the cord blood|The number of the participants analyzed only included the levels for the female offspring.||pg/ml||Standard Deviation|Mean
152553|NCT00364923|Secondary|Overall Survival Per Independent Central Review|Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.|Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.|Analysis was per protocol, based on the number of patients (pts) who had an event (death or censoring) at the time of data cut-off.||Months||Full Range|Median
152554|NCT00364923|Secondary|Progression-free Survival Per Independent Central Review|Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status & survival. Pts who did not have response assessments after baseline were censored at treatment day 1.|Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored. Pts were censored for lack of PD, receipt of other anti-cancer therapy before PD, termination of study/follow-up for response, and transplant.||Days||Full Range|Median
152555|NCT00364923|Secondary|Duration of Response Per Independent Central Review|Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence & reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.|Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol. Based on the number of responding pts (n=32) in the evaluable population (n=109), as assessed by independent central review protocol.||Days||Full Range|Median
152556|NCT00364923|Primary|Response Rate Per Independent Central Review|Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.|Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose|Analysis was per protocol and was based on number of patients (pts) who responded in the evaluable population. The evaluable population consisted of all pts who received at least one dose of pralatrexate and had an eligible peripheral T-cell lymphoma (PTCL) histopathological subtype confirmed by central pathology review.||of Patients who Responded|||Number
152557|NCT00364858|Secondary|Mean Change From Baseline in Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation|The mean composite scores (0 being worst and 100 being best) for both treatment groups approximated those of the general population at baseline. Composite score - The overall composite scores were comprised of a standardized physical and mental component score.|Baseline and Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.||Units on a scale||Standard Deviation|Mean
152558|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Month 24/Discontinuation.|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Month 24/Discontinuation. The mean composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Month 24 (or at time of discontinuation)|Quality of life was evaluated and measured by the SF-36 questionnaire.||Units on a scale||Standard Deviation|Mean
152559|NCT00364858|Secondary|Mean Composite Scores of the SF-36 Health Survey at Baseline|The mean composite scores (0 being worst and 100 being best) for both treatment groups at Baseline. Composite scores for both treatment groups approximated those of the general population at baseline and at Month 24.|Baseline|Quality of life was evaluated and measured by the SF-36 questionnaire.||Units on a scale||Standard Deviation|Mean
152560|NCT00364858|Primary|Number of Participants With Clinical Success at Month 24/Discontinuation|Patients are considered to be a clinical success if ALL of the following are met: The patient’s hemoglobin does not fall more than 1.25g/dL for women or 1.5 g/dL for men below the patient’s baseline value, platelet count does not fall more than 25% below the patient’s baseline value or does not fall below 80,000 mm3, liver and spleen volumes are not greater than 20% above the patient’s baseline value, no evidence of bone disease progression, including no incidence of pathologic fractures, medullary infarctions, lytic lesions or avascular necrosis and has had no bone crises during the study.|Month 24 (or at time of discontinuation)|Intent-to-Treat (ITT) Population. All patients who enrolled in the study and received AT LEAST ONE infusion were included in the ITT population.||patients|||Number
152561|NCT00364845|Secondary|Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data||Units on a scale||95% Confidence Interval|Mean
152563|NCT00364845|Secondary|Number of Participants With Hemoglobin (Hb) ≥ 110 g/L|Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.|Evaluation Period (Weeks 22-36)|Subset of Full Analysis Set, composed of all randomized participants with available data||Participants|||Number
152564|NCT00364845|Primary|Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).|Week 24|Subset of Full Analysis Set, composed of all randomized participants with available data.||Units on a scale||Standard Error|Mean
152565|NCT00364832|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
152566|NCT00364832|Secondary|Number of Participants With Marked Laboratory Abnormalities|Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
152567|NCT00364832|Secondary|Mean Change in Pulse Rate|Mean change in pulse rate was reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug. Participants with available data at the time of evaluation were analyzed.||Beats per minute||Standard Deviation|Mean
152568|NCT00364832|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks –2 and –1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Millimeters of Mercury||Standard Deviation|Mean
152569|NCT00364832|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.||Percentage of Hct||Inter-Quartile Range|Median
152570|NCT00364832|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and –1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21)|The ITT population was considered for analysis which included all randomized participants.||gram per deciliter||Inter-Quartile Range|Median
152571|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.||percentage of CD4 cells||Inter-Quartile Range|Median
152572|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.||cells/mm^3||Inter-Quartile Range|Median
152573|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Weeks 60, 72, 84, and 96|Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.||log10 c/mL||Inter-Quartile Range|Median
152574|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 50 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.||participants|||Number
152575|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants|Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 400 c/mL; denominator was all who remained on treatment through the specific week.|Weeks 60, 72, 84, and 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.||participants|||Number
152576|NCT00364793|Secondary|Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||h||Standard Deviation|Mean
152577|NCT00364793|Secondary|CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
152578|NCT00364793|Secondary|CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
152579|NCT00364793|Secondary|AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms*time per milliliter (ng•h/mL).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
152580|NCT00364793|Secondary|Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were <LLOQ in all age groups except >=6 months to < 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were <LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
152850|NCT00361972|Primary|Change in Lymphocyte Count|Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups.|Baseline and 6 weeks|||Lymphocytes per square millimeter||Standard Deviation|Mean
152581|NCT00364793|Secondary|Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population|PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC<110 μM*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: > 3.3* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).|Baseline to Week 48|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles at Week 2 were analyzed. n=number of participants with AUC<110 µM•h and number of participants with AUC>=110 µM•h.||participants|||Number
152582|NCT00364793|Secondary|Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound|At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: > 3.1* the 50% inhibitory concentration (IC50) of the control strain; EFV: > 3.3* IC50 ; ddI: > 2.6*IC50. Virologic failure: <1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA > 10,000 c/mL with prior value < 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.|Baseline to Week 48|Participants who met the definition of virologic failure per protocol (PP): n=6 ; in addition, those who rebounded on treatment with plasma HIV RNA > 10,000 c/mL but samples were not obtained within specified 35 day limit were included (not PP): n=5; participants with virologic failure and with samples available for analysis of virus changes:n=11.||participants|||Number
152583|NCT00364793|Secondary|Number of Participants With Hematologic Abnormalities - Treated Participants|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: <6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999*10^9/L; Gr 2: 50.000-99.999*10^9/L; Gr 3: 25.000-49.999*10^9/L; Gr 4: <25.000*10^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500*10^9/L; Gr 2: 1.500-1.999*10^9/L; Gr 3: 1.000-1.499*10^9/L; Gr 4: <1.000*10^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
152584|NCT00364793|Secondary|Number of Participants With Serum Chemistry Abnormalities - Treated Participants|Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - < LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: <8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: >13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: <6.1 mg/dL; creatinine Gr1: 1.1-1.3*ULN; Gr 2: 1.4-1.8*ULN; Gr 3: 1.9-3.4*ULN; Gr 4: >=3.5*ULN; lipase Gr 1: 1.1-1.5*ULN; Gr 2: 1.6-3.0*ULN; Gr 3: 3.1-5.0*ULN; Gr 4: >5.0*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: >7.0 (<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: >=160 (<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: >15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
152585|NCT00364793|Secondary|Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants|Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 >300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 >=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: >1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: >500 (> 500) mg/dL. Glucose, serum, low, >=1 month of age (<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: <30 (<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
152593|NCT00364793|Secondary|Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants|HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline through Week 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.||log10 c/mL||Inter-Quartile Range|Median
153163|NCT00359788|Secondary|FVC at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
152586|NCT00364793|Secondary|Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population|Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. AST Gr 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. Total bilirubin Gr 1: 1.25 to 1.5*ULN; Gr 2: 1.6 to 2.5*ULN; Gr 3: 2.6 to 5.0*ULN; Gr 4: >5.0*ULN. ALP (U/L) Gr 1: 1.25 to 2.5*ULN, Gr 2: 2.6 to 5.0*ULN, Gr 3: 5.1 to 10.0*ULN, Gr 4: >10.0*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to <LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: < 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Week 96|Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).||participants|||Number
152587|NCT00364793|Secondary|Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events|Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).|Baseline to Week 96|All categories except one analyzed treated participants, who received at least 1 dose of study drug (EFV). One category analyzed enrolled participants who were not treated and cannot be assigned to a group.||participants|||Number
152588|NCT00364793|Primary|Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
152589|NCT00364793|Primary|Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||L/h||Geometric Coefficient of Variation|Geometric Mean
152590|NCT00364793|Primary|Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population|Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars*time (µM•h).|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||µM•h||Geometric Coefficient of Variation|Geometric Mean
152591|NCT00364793|Secondary|Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.||percentage of CD4 cells||Inter-Quartile Range|Median
152592|NCT00364793|Secondary|CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants|A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).|Baseline to Weeks 24 and 48|Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.||cells/mm^3||Inter-Quartile Range|Median
152594|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
152595|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 24.|Week 24|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
152596|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
152597|NCT00364793|Secondary|The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants|Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.|Week 48|Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.||participants|||Number
152598|NCT00364793|Primary|Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population|Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.|Week 2|All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
152599|NCT00364611|Secondary|Number of Participants With Adverse Events (AE)|"An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs).~An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important."|From treatment initiation to 30 days after the last dose of study treatment|Safety population: all participants who received at least one dose of study medication||participants|||Number
152600|NCT00364611|Secondary|Overall Survival (OS) Time|"OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.~OS time was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.||days|Participants|Inter-Quartile Range|Median
152750|NCT00362466|Secondary|Best MMR Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.|throughout study|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
152601|NCT00364611|Secondary|Duration of Response (DR)|"DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression.~Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy.~DR was estimated from Kaplan-Meier Plots."|From treatment initiation to June 2011|Participants with a documented response of CR or PR.||days|Participants|95% Confidence Interval|Median
152602|NCT00364611|Secondary|Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria|"Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD).~According to RECIST~CR was the disappearance of all tumor lesions~PR was a pre-defined decrease in the size of tumor lesions~SD was neither sufficient decrease in tumor size to qualify for PR or sufficient increase to qualify for PD.~Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD)."|From treatment initiation to June 2011|Intent-to-treat: all registered participants.||participants|||Number
152603|NCT00364611|Secondary|Confirmed Overall Response (OR) Based on RECIST Criteria|"Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST~CR was the disappearance of all tumor lesions~PR was a pre-defined decrease in the size of tumor lesions.~To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required."|From treatment initiation to June 2011|Intent-to-treat population: all registered participants.||participants|||Number
152604|NCT00364611|Primary|Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest of the following documented dates:~PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance)~symptomatic deterioration~death.~Time to PFS was estimated from Kaplan-Meier Plots."|From treatment initiation to PFS event (up to June 2011)|Intent-to-treat population: all registered participants||days|Participants|95% Confidence Interval|Median
152605|NCT00364611|Primary|Progression-free Survival (PFS) Rate: Percentage of Participants With PFS|"PFS was the time from registration to first documentation of~progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance~symptomatic deterioration~death due to any cause (in absence of PD).~The Percentage of participants with PFS is reported.~For the analysis, participants were censored~on the last available tumor assessment date on study treatment if they~had no PFS event~were on anticancer therapy not related to study treatment~on the registration date if they~did not receive study drug~had no post baseline tumor assessment"|Up to 6 months and 12 months after treatment initiation|Intent to treat population: all registered participants||percentage of participants||95% Confidence Interval|Number
152606|NCT00364533|Secondary|The SPID at 12, 24, and 72 Hours Relative to First Dose.|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|3 days|Due to termination of trial, results were not analyzed.|||||
152607|NCT00364533|Secondary|Time to First Rescue Pain Medication.||3 days|Due to termination of trial, results were not analyzed.|||||
152608|NCT00364533|Primary|Sum of Pain Intensity Difference Over 48 Hours (SPID48)|The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.|48 hours|Because the Sponsor terminated the study, the planned sample size was not reached in any treatment group, therefore, only a brief summary of an exploratory analysis of the primary efficacy variable (SPID48) is presented.||score on a scale||Standard Deviation|Mean
152609|NCT00364377|Primary|Lowering of Fasting Glucose|fasting glucose taken as the mean of blood glucose measured at -30, -20, -10 and 0 minutes prior to each inpatient meal study|8 weeks|Analysis was per protocol - all participants completed the intervention||mmol/l||Standard Error|Mean
152610|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough|"Cough was assessed using Question 1 (How much did you cough) of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||Weeks||Inter-Quartile Range|Median
152611|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea|"Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 (Were you short of breath) and Question 3 of the QLQ-C30 (Were you short of breath when you rested), Questions 4 (Were you short of breath when you walked) and 5 (Were you short of breath when you climbed stairs) of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||Weeks||Inter-Quartile Range|Median
152779|NCT00362414|Secondary|Fugl-Meyer Leg Scale|"Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered normal."|3 mo.|||Units on a scale||Full Range|Median
152612|NCT00364351|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain|"Pain was assessed as the average score of two items: Question 9 (Have you had pain) and 19 (Did pain interfere with your daily activities) of the QLQ-C30.~Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 28 days."|Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit|||Weeks||Inter-Quartile Range|Median
152613|NCT00364351|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.|RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression|||Participants|||Number
152614|NCT00364351|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months|||Participants|||Number
152615|NCT00364351|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||Full Range|Median
152616|NCT00364351|Primary|Progression-Free Survival (PFS)|"Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment.~Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions."|progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.|||Weeks||Full Range|Median
152617|NCT00364130|Secondary|Change in QCT Tibia Trabecular Volumetric BMD at 12 Months|We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT)|12 months|||cm^3||Standard Deviation|Mean
152618|NCT00364130|Secondary|Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months|We calculated the mean change in whole body bone mineral content Z-score, as measured by DXA, between baseline and 12 months|12 months|||Z-score||Standard Deviation|Mean
152619|NCT00364130|Secondary|Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in femoral neck areal bmd Z-score between baseline and 12 months as measured by DXA|12 months|||Z-score||Standard Deviation|Mean
152620|NCT00364130|Secondary|Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months|We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months|12months|||Z-score||Standard Deviation|Mean
152621|NCT00364130|Secondary|Change in Posteroanterior Lumbar Spine Areal BMD Z-score|We calculated the mean change in posterior anterior lumbar spine areal BMD Z-score between baseline and 12 months as measured by DXA|12 months|||Z-score||Standard Deviation|Mean
152622|NCT00364130|Primary|Change in Spine Volumetric BMD Z-score at 12 Months|We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.||Z-score||Standard Deviation|Mean
152623|NCT00364130|Primary|Change in Tibia Cortical Area Z-score 12 Months|We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.||Z-score||Standard Deviation|Mean
152624|NCT00364130|Primary|Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months|"We calculated the mean change in tibia trabecular volumetric BMD Z-score between baseline and 12 months, as measured by peripheral quantitative computed tomography (pQCT).~The Z-score, or Standard Deviation Score, is a measure of the number of standard deviations that an individual is above or below the median value in a healthy child or adolescent of the same age, sex and race. For example, a Z-score of 0 means that an individual's result is equivalent to the 50th percentile in a healthy population. A Z-score of -1.0 means that an individual's result is equovalent to the 16th percentile in a healthy population."|12 months|The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat.||Z-score||Standard Deviation|Mean
152638|NCT00363805|Primary|Change in Urinary 8-F2-isoprostanes Levels|the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identity of the analyte was confirmed in the sample.||ng/mg creatinine||Standard Deviation|Mean
152625|NCT00364013|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: “Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.|Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX’, but received ‘FOLFOX Alone’ so is counted in that group.||participants|||Number
152626|NCT00364013|Secondary|Duration of Response|Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set: Responders||months||95% Confidence Interval|Median
152627|NCT00364013|Secondary|Time to Progression|Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria.|From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
152628|NCT00364013|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.|KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review).||percentage of participants||95% Confidence Interval|Number
152629|NCT00364013|Secondary|Overall Survival|The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date.|From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
152630|NCT00364013|Primary|Progression-free Survival|Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.|From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)||months||95% Confidence Interval|Median
152631|NCT00363896|Primary|Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks|Week 12|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
152632|NCT00363896|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Percentage of Patients|||Number
152633|NCT00363896|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|"Time to first moderate or severe exacerbation:~Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation."|Week 52|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Days||95% Confidence Interval|Median
152634|NCT00363896|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks|Week 28|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
152635|NCT00363883|Secondary|Progression-free Survial|Will be estimated using the product-limit method of Kaplan and Meier. Progression defined using RECIST v1.0 criteria, at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions.|assessed up to 26 weeks|||months||95% Confidence Interval|Median
152636|NCT00363883|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|Up to 26 weeks|||months||95% Confidence Interval|Median
152637|NCT00363883|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Response assessed after every 2 cycles (6 weeks) up to 26 weeks|||percentage of patients|||Number
152639|NCT00363805|Primary|Change in Urinary 8-hydroxydeoxyguanosine Levels|the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels|Baseline and 6 months|The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identify of the analyte was confirmed in the sample.||ng/mg creatinine||Standard Deviation|Least Squares Mean
152640|NCT00363779|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 months|||Participants|||Number
152641|NCT00363779|Primary|Changes in Gene Expression Patterns|The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.|Baseline and 12 weeks|This outcome measure was not performed because there were insufficient data points to provide any statistical power.|||||
152642|NCT00363675|Primary|Moberg Pickup Test|The child picks up 12 small objects such as a coin, safety pin and paper clip one at a time and puts them in a container. The time in seconds to complete the task is the score.|Seconds to pick up all 12 objects|A convenience sample was planned for this study.||Seconds||Full Range|Median
152643|NCT00363675|Primary|Grip Strength|This is a measure of grip strength in pounds using a dynamometer. The subject squeezes the dynamometer as hard as possible for three trials separated by a short rest. The mean of the three trials is the score.|Baseline|Convenience sample was planned for this study.||Pounds||Full Range|Median
152644|NCT00363675|Primary|Range of Motion, Total Active Motion (TAM)|Subjects' degrees of hand motion are measured by a trained therapist and recorded. Total Active Motion is a measure of finger range of motion that can be used to predict functional movement of the hand. The TAM is the sum of the degrees of active motion of each of the three joints of the fingers, and two joints of the thumb. For this study we also included wrist motion. Full TAM is 1,455 degrees of motion.|Baseline|Convenience sample was planned for ths study.||Degrees||Full Range|Median
152645|NCT00363675|Primary|Blocks & Box (Standardized Test).|Children are asked to move as many blocks as possible from one box to another in one minute. The number of blocks moved is the score.|Baseline|Convenience sample was planned for this study.||Blocks||Full Range|Median
152646|NCT00363467|Secondary|1 Year Overall Survival|Number of participants alive at 1 year posttransplant|1 year post transplant|||participants|||Number
152647|NCT00363467|Secondary|1 Year Event-free Survival|Number of participants alive and without disease relapse at 1 year posttransplant|1 year post transplant|||participants|||Number
152648|NCT00363467|Secondary|Severe Regimen-related Toxicity|Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4.|up to 100 days post translant|||participants|||Number
152649|NCT00363467|Secondary|Successful Autologous Stem Cell Collection|Number of subjects who were able to collect at least 2 million CD34+ cells/kg|At time of stem cell collection|per protocol||participants|||Number
152650|NCT00363467|Primary|100-day Non-relapse Mortality|100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease|100 days post transplant|"Analysis was per protocol"||participants|||Number
152651|NCT00363415|Post-Hoc|Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes|Number of participants with Low Density Lipoprotein <=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes).|baseline to date of death due to any cause (up to 19.6 months)|Number of randomized participants.||participants|||Number
152652|NCT00363415|Secondary|Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)|The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.|baseline to date of death due to any cause (up to 19.6 months)|The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup.||months||95% Confidence Interval|Median
152653|NCT00363415|Secondary|Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy – Lung (FACT-L)|FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.|baseline and 6 cycles (21-day cycles)|Number of randomized participants with baseline and non-missing value at respective cycle.||units on a scale||Standard Deviation|Mean
152654|NCT00363415|Secondary|Progression Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline to measured progressive disease (up to 14.7 months)|All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin.||months||95% Confidence Interval|Median
152655|NCT00363415|Secondary|Overall Survival (Subgroups)|The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.|baseline to date of death from any cause (up to 19.6 months)|Number of randomized participants.||months||95% Confidence Interval|Median
152656|NCT00363415|Primary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 19.6 months)|Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored.||months||95% Confidence Interval|Median
152657|NCT00363311|Secondary|Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)|"The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I feel close to my friends., I get emotional support from my family., I get support from my friends., My family has accepted my illness., I am satisfied with family communication about my illness., I feel close to my partner (or the person who is my main support)., I am satisfied with my sex life. The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152658|NCT00363311|Secondary|Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)|"The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; I have a lack of energy., I have nausea., Because of my physical condition, I have trouble meeting the needs of my family., I have pain., I am bothered by side effects of treatment., I feel ill., I am forced to spend time in bed. The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life."|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152659|NCT00363311|Secondary|Percent Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152660|NCT00363311|Secondary|Change From Baseline in Total FACT-P Score (LOCF)|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.|Baseline and Months 18 and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152661|NCT00363311|Secondary|Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score|The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.|Baseline and Months 18 and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152662|NCT00363311|Secondary|Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152663|NCT00363311|Secondary|Total MAX-PC Fear of Recurrence Subscale Score|"The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; Because cancer is unpredictable, I feel I cannot plan for the future., My fear of having my cancer getting worse gets in the way of my enjoying life., I am afraid of my cancer getting worse., I am more nervous since I was diagnosed with prostate cancer. A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152664|NCT00363311|Secondary|Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152674|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
152665|NCT00363311|Secondary|Total MAX-PC Anxiety Subscale Score Related to PSA Testing|"The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; I have been so anxious about my PSA test that I have thought about delaying it., I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test., I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate. A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9."|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152666|NCT00363311|Secondary|Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Months 3, 6, 12, 18, and 36|ITT Population. Only participants with both available baseline and post-baseline values were analyzed at the indicated time points. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152667|NCT00363311|Secondary|Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)|The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.|Baseline and Month 3, 6, 12, 18, and 36|ITT Population. As the study progressed, participants dropped out of the study or did not complete the questionnaire.||points on a scale||Standard Deviation|Mean
152668|NCT00363311|Secondary|Percent Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.||percent change||Standard Deviation|Mean
152669|NCT00363311|Secondary|Change From Baseline in Prostate Volume at Years 1.5 and 3|"Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study.||cc||Standard Deviation|Mean
152670|NCT00363311|Secondary|Prostate Volume (PV) LOCF|"Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:~π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements."|Baseline and Years 1.5 and 3|ITT Population. As the study progressed, participants dropped out of the study. Last observation carried forward (LOCF) was used.||cubic centimeters (cc)||Standard Deviation|Mean
152671|NCT00363311|Secondary|Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage|"All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as No Worsening."|Months 0-18|ITT Population. As the study progressed, participants dropped out of the study.||biopsies|||Number
152672|NCT00363311|Secondary|Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.|Baseline|ITT Population||biopsies|||Number
152673|NCT00363311|Secondary|Number of Participants With the Indicated Total Gleason Score|All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.|Years 0-3 (Final Biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
152685|NCT00363311|Secondary|Number of Participants With Therapeutic Progression|Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.|Year 1.5 and Overall (Years 0-3)|ITT Population||participants|||Number
152780|NCT00362414|Secondary|Fugl-Meyer Arm Scale|"Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered normal with no impairments."|3 mo|||Units on a scale||Full Range|Median
152675|NCT00363311|Secondary|Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5|The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).|Year 1.5|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
152676|NCT00363311|Secondary|Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||millimeters||Standard Deviation|Mean
152677|NCT00363311|Secondary|Cumulative Length of Cancer Tumor Core|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||millimeters||Standard Deviation|Mean
152678|NCT00363311|Secondary|Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||percentage of cores||Standard Deviation|Mean
152679|NCT00363311|Secondary|Mean Percentage of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||percentage of cores||Standard Deviation|Mean
152680|NCT00363311|Secondary|Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||cores||Standard Deviation|Mean
152681|NCT00363311|Secondary|Number of Cancer-positive Cores in a 12-core Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)|ITT Population. As the study progressed, participants dropped out of the study.||cores||Standard Deviation|Mean
152682|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy|All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.|Years 0-3|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
152683|NCT00363311|Secondary|Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis|All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.|Baseline to Month 18|ITT Population. As the study progressed, participants dropped out of the study.||participants|||Number
152684|NCT00363311|Secondary|Number of Participants With Pathologic Progression|Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population. As the study progressed, participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.||participants|||Number
152686|NCT00363311|Primary|Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression|PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.|Year 1.5 and Overall (Years 0-3)|ITT Population: all participants randomized to study treatment. Some participants dropped out of the study prior to meeting the primary endpoint for reasons other than disease progression or refused to have a biopsy performed.||participants|||Number
152687|NCT00363246|Primary|Wheelchair-related Falls|Wheelchair-related falls in 1 year follow-up period.|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility.||participants|||Number
152688|NCT00363246|Secondary|Injuries From Wheelchair-related Falls|Wheelchair-related falls that resulted in an injury in the one year follow up period|one year follow-up period|Older veterans who use a wheelchair for their primary means of mobility. Analyzed for wheelchair-related fall injury during 1-year follow-up period.||participants|||Number
152689|NCT00363168|Secondary|Number of Subjects Experiencing Complications Related to Drug or Its Administration|"Potential complications included:~Deterioration of best-corrected visual acuity by 3 or more lines~Development of intraocular inflammation~Development of elevated intraocular pressure~Development of other ocular or systemic adverse effects.~Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function."|12 months after last injection|||participants|||Number
152690|NCT00363168|Secondary|Fluorescein Leakage on Fluorescein Angiography||12 months||||||
152691|NCT00363168|Secondary|Retinal Thickness Measured by Optical Coherence Tomography (OCT)||12 months||||||
152692|NCT00363168|Secondary|Retinal Changes on Funduscopy||12 months||||||
152693|NCT00363168|Primary|Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.|Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.|12 months|||participants|||Number
152694|NCT00363142|Secondary|Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24|Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented.|Weeks 12 and 24|PK Parameter (Ctau) Population - Participants in the ITT-E Population who underwent PK sampling and had evaluable APV or RTV Ctau data.||micrograms/mL||95% Confidence Interval|Geometric Mean
152695|NCT00363142|Secondary|Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class.|Baseline through Week 24|Participants in the ITT-E Population who met the virologic failure definition||Participants|||Number
152696|NCT00363142|Secondary|Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24|A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population||Percent change||Full Range|Median
152697|NCT00363142|Secondary|Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24|A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.|Baseline and Week 24|Safety Population||Percent change||Full Range|Median
152698|NCT00363142|Secondary|Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24|The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.|Baseline through Week 24|Safety Population||participants|||Number
152699|NCT00363142|Secondary|Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline through Week 24|Safety Population: all randomized subjects who consumed at least one dose of study drug and was analyzed according to the treatment received.||participants|||Number
152700|NCT00363142|Secondary|Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis|A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24||cells/mm3||Full Range|Median
152701|NCT00363142|Secondary|Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline.|Baseline and Week 24|ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24||log10 copies/mL||Standard Deviation|Mean
152702|NCT00363142|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA <50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population||Percentage of participants|||Number
152703|NCT00363142|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis|A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA <400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.|Week 24|ITT-E Population||Percentage of participants|||Number
152704|NCT00363142|Primary|Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24|Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.|Week 24|Intent-to-Treat Exposed (ITT-E) Population. Subjects who received at least one dose of investigational product.||Percentage of participants|||Number
152705|NCT00363129|Secondary|Duration of Sensory Peripheral Neuropathy ≥ Grade 2|Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.|6 months post completion of chemotherapy treatment|||days||95% Confidence Interval|Median
152706|NCT00363129|Secondary|Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2|Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.|6 months post completion of chemotherapy treatment|||days||95% Confidence Interval|Median
152707|NCT00363129|Secondary|Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment|||percentage of participants|||Number
152708|NCT00363129|Secondary|Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy||6 months post completion of chemotherapy treatment|||percentage of patients|||Number
152709|NCT00363129|Primary|Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2|The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.|6 months post completion of chemotherapy treatment|Participants who received at least one dose of assigned therapy.||percentage of participants|||Number
152710|NCT00363077|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE considered by the investigator to have a causal relationship to study vaccination.|During the entire study period (from Day 0 to Day 29)|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
152711|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
152712|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
152713|NCT00363077|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.||subjects|||Number
152748|NCT00362609|Secondary|Area Under the Concentration-time Curve (AUC)|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.|Baseline to 24 hours post dose on Day 1|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.||ng*hr/mL||Standard Deviation|Mean
152714|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
152715|NCT00363077|Secondary|Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||cytokine-positive cells/million cells||Standard Deviation|Geometric Mean
152716|NCT00363077|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||fold increase||95% Confidence Interval|Geometric Mean
152717|NCT00363077|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 0 and Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||subjects|||Number
152718|NCT00363077|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.|At Day 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||subjects|||Number
152719|NCT00363077|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.|At Days 0 and 21|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.||titers||95% Confidence Interval|Geometric Mean
152720|NCT00363051|Secondary|Effect of Octreotide Depot on the Trough Concentrations of Everolimus|The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.|Cycle 1 Day 1, Cycle 2 Day 1|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with Octreotide Depot pharmacokinetic samples, with nonzero concentration, at Cycle 1 Day 1 or Cycle 2 Day 1 were included.||ng/ml||Standard Deviation|Mean
152721|NCT00363051|Secondary|Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)|For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.|Cycle 1 Day 15|Full Analysis Set (FAS) is consisted of all patients who received at least one dose of everolimus. Patients with everolimus pharmacokinteic samples, with nonzero concentration, at Cycle 1 Day 15 were included||ng/ml||Standard Deviation|Mean
152722|NCT00363051|Secondary|Time to Overall Survival (OS) (Stratum 2)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.~If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.||months||95% Confidence Interval|Median
152723|NCT00363051|Secondary|Time to Overall Survival (OS)(Stratum 1)|"Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause.~If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed."|from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012|The full analysis set consisted of all patients who received at least one dose of everolimus.||months||95% Confidence Interval|Median
153026|NCT00360360|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|||months||95% Confidence Interval|Median
152724|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.~Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.||Months||95% Confidence Interval|Median
152725|NCT00363051|Secondary|Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)|"Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed.~Median PFS was obtained and displayed along with 95% confidence intervals."|from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.||Months||95% Confidence Interval|Median
152726|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.||Participants|||Number
152727|NCT00363051|Secondary|Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month|The safety population consists of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment.||Participants|||Number
152728|NCT00363051|Secondary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)|Full Analysis Set (FAS) was consisted of all patients who received at least one dose of everolimus.||percentage of participants||95% Confidence Interval|Number
152729|NCT00363051|Secondary|Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):~Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.~Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.~Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Very low number of patients demonstrated a partial response, the median duration of response as per central review has not been calculated.|||||
152730|NCT00363051|Secondary|Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review|"Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR):~Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression.~Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.~Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions"|from date of first documented confirmed response to time to progression, at least 3 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus. Only those patients whose best overall response was complete response (CR) or partial response (PR) were included in this analysis.||Months||95% Confidence Interval|Median
152749|NCT00362609|Primary|Variance of Oral Bioavailability|Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2.|1 day|Single dose PK Valid-For Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and taken the test article on the date the PK samples were taken). 2 poor metabolizers were excluded from this analysis.||ratio|||Number
152731|NCT00363051|Primary|Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.|from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)|The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.||percentage of participants||95% Confidence Interval|Number
152732|NCT00363038|Primary|Average Bruise Change|Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).|Baseline and 2 weeks|||Units on a Scale||Standard Deviation|Mean
152733|NCT00362882|Secondary|Progression-free Survival||6 months||||||
152734|NCT00362882|Secondary|Disease Control Rate|Disease control rate was defined as the rate of partial response (PR) plus stable disease (SD; for at least 2 cycles).|Up to 4 years|||percentage of participants|||Number
152735|NCT00362882|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier.|From first day of treatment to time of death due to any cause, up to 4 years|||Months||95% Confidence Interval|Median
152736|NCT00362882|Primary|Overall Response Rate for PS-341 and Docetaxel Given in Two Sequences and to Decide Whether This Combination Warrants Further Study|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 years|||percentage of participants|||Number
152737|NCT00362817|Secondary|Quality of Life Assessment|To determine the impact of treatment on quality of life.|up to 2 years|Quality of Life Assessment was not done.|||||
152738|NCT00362817|Secondary|The Incidence and Severity of Centeral Nervous System (CNS) Toxicities|To determine the incidence and severity of CNS toxicity in patients treated with intra-arterial carboplatin and oral temozolomide.|up to 24 weeks|||patients|||Number
152739|NCT00362817|Secondary|Determine the Cause of Death of Patients After Treatment|To determine the cause of death (i.e., CNS tumor versus systemic disease progression) in patients after treatment.|up to 1 year|||patients|||Number
152740|NCT00362817|Secondary|Determine the Overall Survival of Patients|From the time of protocol initiation|up to 64 weeks|||weeks||Full Range|Mean
152741|NCT00362817|Secondary|Analyze Patients Time to Progression|"Responses to treatment was determined by comparing new enhanced MRI scans with those obtained at the previous evaluation (i.e., 2 treatment cycles ago) or with the pre-IA chemotherapy baseline scan, if it is the first follow-up MRI scan during treatment.~MRI is the neuro-imaging modality of choice, since it is more accurate than CT for small tumors, multiple tumors, and tumors in the posterior fossa.58 The methodology used (techniques and equipment) must be identical for all scans. Lesions should be measured as the largest diameter seen on scan and the largest diameter perpendicular to that dimension."|up to 60 weeks|||weeks||Full Range|Mean
152742|NCT00362817|Primary|Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide|Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a >50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progressive disease occurs when there is a >25% increase in size of enhancing tumor on consecutive MRI scans. Stable disease occurs in all remaining situations.|up to 1 year|||percentage of patients with response|||Number
152743|NCT00362648|Secondary|Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population||Subjects|||Number
152744|NCT00362648|Secondary|Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]|Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)|14 days following the 3rd vaccination|"Per Protocol Population~*N analyzed for Serotype P1A[8] is 188"||Subjects|||Number
152745|NCT00362648|Primary|Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose||At least 14 days following the third vaccination|Per Protocol Population||Subjects|||Number
152746|NCT00362609|Secondary|Half Life|Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.||hours||Standard Deviation|Mean
152747|NCT00362609|Secondary|Apparent Oral Clearance (Cl/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling.|1 day|Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.||L/hr/kg||Standard Deviation|Mean
152751|NCT00362466|Secondary|Duration of CCyR and MMR|Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.|Throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.||months|||Number
152752|NCT00362466|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.|All treated participants||events|||Number
152753|NCT00362466|Secondary|Progression Free Survival (PFS)|PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.|at 36 months|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
152754|NCT00362466|Secondary|Estimate Time to MMR and CCyR|Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.|throughout the study|This analysis was not done. This study was terminated due to insufficient enrollment.||months|||Number
152755|NCT00362466|Secondary|CCyR Rates|CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 3, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.||Participants|||Number
152756|NCT00362466|Secondary|Major Molecular Response (MMR) Rates|MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.|Month 3, Month 6, Month 12, Month 24 and Month 36|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
152757|NCT00362466|Primary|Complete Cytogenetic Response (CCyR) Rate at Month 6|Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.|Month 6|This analysis was not done. This study was terminated due to insufficient enrollment.||participants|||Number
152758|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Mental Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline to 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
152759|NCT00362453|Secondary|Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.|Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Physical Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.|baseline, 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
152760|NCT00362453|Secondary|Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.|"Self-efficacy is important for individuals to adopt and maintain a program of regular physical activity. The patient rates his/her confidence of being physically active in different types of situations on a 5-item scale with responses ranging from not at all confident to extremely confident. The total score is coputed by calculating the average of all 5 questions. A higher score indicates greater self-efficacy. Higher numbers reported here indicate more improvement from baseline."|baseline to 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
152761|NCT00362453|Secondary|Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.|The CES-D was used to assess depressive symptoms. It included a 20-item Likert-type scale with scores ranging from 0 to 60. Higher scores indicated greater dysphoria. Negative numbers reported here indicate improvement in condition from baseline. (So -1 indicates a 1-point improvement from baseline.)|baseline to 12, 24, 48 weeks|||units on a scale||95% Confidence Interval|Mean
152762|NCT00362453|Secondary|Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.|The standing balance test included tandem, semi-tandem, side-by-side, and one-legged stands. Patients were asked to maintain each position for 30 seconds. For each task, the research staff first demonstrated the task, asked the patient if they felt comfortable and ready and then supported the patient while positioning themselves. One point was given if they exceeded 30 seconds and none if they could not or did not attempt the test. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 19 patients in Attention Control group was analyzed for 48-week timepoint due to availability of data.||units on a scale||95% Confidence Interval|Mean
152834|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152763|NCT00362453|Secondary|Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.|The 6 minute walk test is a reliable measure of functional exercise capacity. Patients were asked to walk as fast and as far as possible within the 6-minute period and were accompanied by the research staff using a wheel measure that measured distance covered in inches and convereted to yards; higher scores indicated improved state. Higher numbers reported here indicate more improvement from baseline.|baseline to 12, 24, 48 weeks|Note: Data for only 18 patients from Tai chi group was analyzed for 12 week timepoint. Data for 19 patients from the Attention Control group was analyzed at 48 week timepoint.||yards||95% Confidence Interval|Mean
152764|NCT00362453|Secondary|Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.|Timed stand tests measure the time taken to complete ten full stands from a sitting position. Patients began the chair stand seated with their arms folded across their chests, then rose to a standing position and sat back down with their back against the back rest of the chair. The test was completed when the patient stood for the tenth repetition. Chair stand time was measured in seconds, with lower scores indicating improved state. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-second improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 18 participants in the Attention Control group was analyzed for the 48-week timepoint to do availability of data.||seconds||95% Confidence Interval|Mean
152765|NCT00362453|Secondary|Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.|The study physician who was blinded to group assignment completed a global knee pain assessment VAS with scores ranging from 0 to 10cm; 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks|Note: Data for only 19 participants in the Attention Control group was analyzed at 48 Weeks due to lack of available data.||cm||95% Confidence Interval|Mean
152766|NCT00362453|Secondary|Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)|Participants completed a self-reported knee-specific global pain VAS with scores ranging from 0 to 10 centimeters (cm); 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)|baseline to 12, 24, 48 weeks|||cm||95% Confidence Interval|Mean
152767|NCT00362453|Secondary|Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The WOMAC was administered to the participants at baseline, 12, 24 and 48 weeks. The pain subscale score range was 0-500mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|baseline to 24, 48 weeks|The 12-Week WOMAC scores are listed under Primary Outcome. The 24-Week and 48-Week scores are listed as Secondary Outcomes.||mm||95% Confidence Interval|Mean
152768|NCT00362453|Secondary|Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The stiffness subscale has a score range 0-200mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|baseline to 12, 24, 48 weeks|||mm||95% Confidence Interval|Mean
152769|NCT00362453|Secondary|Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.|The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The function subscale had a score range 0-1700mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)|from baseline to 12, 24, 48 weeks|||mm||95% Confidence Interval|Mean
152770|NCT00362453|Primary|Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks|WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)|between baseline and 12 weeks.|We analyzed the data on an intent-to-treat basis.||mm||95% Confidence Interval|Mean
152771|NCT00362414|Secondary|Trail Making B Test|Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo.|||correct connections||Full Range|Median
152772|NCT00362414|Secondary|Trail Making A Test|Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.|3 mo|||correct connections||Full Range|Median
152773|NCT00362414|Secondary|Infarct Volume Using Anatomical MRI|Measurement of infarct volume and percent change from baseline to Day 90.|3 mo|||percent change||Standard Error|Mean
152774|NCT00362414|Secondary|Barthel Index|Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence.|3 mo|||Units on a scale||Full Range|Median
152775|NCT00362414|Secondary|Geriatric Depression Scale Short Form|Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression.|3 mo|||Units on a scale||Full Range|Median
152776|NCT00362414|Secondary|NIH Stroke Scale|Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke.|3 mo|||Units on a scale||Full Range|Median
152777|NCT00362414|Secondary|Line Cancellation Test|Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect.|3 mo|||ratio of canceled lines on each side||Full Range|Median
152778|NCT00362414|Secondary|Boston Naming Test|Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture.|3 mo|||Units on a scale||Full Range|Median
152781|NCT00362414|Secondary|Action Research Arm Test|"The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered normal."|3 mo|This number (9) is the total # subjects who could complete the test at all study time points; some subjects were unable to complete this test at one of the time points, especially the acute stroke assessment.||Units on a scale||Full Range|Median
152782|NCT00362414|Primary|Mortality|attributable to experimental intervention|3 mo|||participants|||Number
152783|NCT00362414|Primary|Morbidity|attributable to experimental intervention|3 mo|||participants|||Number
152784|NCT00362414|Primary|Safety|Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.|3 mo|||participants|||Number
152785|NCT00362401|Primary|Intensity (Highness) of the Sound From Mechanical Heart Valves|The measurements took place in a Bioacoustic laboratory. The total background noise was 9 dB(A). The valve closing sounds were recorded by a microphone placed 5 cm above the patient’s chest. This sound was pre-amplified, amplified, filtered and stored on an instrumentation recorder for later off-line analysis.|10.06.2007|Patients with a mechanical heart valve prosthesis recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.||dB (decibel)||Standard Deviation|Mean
152786|NCT00362375|Secondary|Knowledge of HIV Test||current||||||
152787|NCT00362375|Secondary|Condom Use Self-efficacy||current||||||
152788|NCT00362375|Secondary|HIV Knowledge||current||||||
152789|NCT00362375|Secondary|HIV Testing and Receipt of Results|Percentage of women who reported testing for HIV infection and received their test results during the past 3 months|Past 3 months|Based on the number of women who provided data at the 3-month follow-up||Percent|||Number
152790|NCT00362375|Other Pre-specified|Number of Male Sex Partners|The number of male sex partners during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up||Number of sex partners||Standard Deviation|Mean
152791|NCT00362375|Other Pre-specified|Unprotected Vaginal Sex With Any Male Partner|The percentage of women who engaged in unprotected vaginal sex (i.e., did not use a condom) with any male partner during the past 3 months|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up||Percent|||Number
152792|NCT00362375|Other Pre-specified|Sexual Abstinence|The percentage of women who did not engage in vaginal, oral or anal sexual intercourse with male partners|Past 3 months|Based on the number of women who provided valid data at the 3-month follow-up||Percent|||Number
152793|NCT00362375|Primary|Condom Use During Vaginal Sex With Any Male Partner|Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months|Past 3 months|Women who were sexually active at 3-month follow-up and who provided data on outcome measure||Percent|||Number
152794|NCT00362336|Secondary|Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post-booster vaccination|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received (Safety Analysis Population).||Participants|||Number
152795|NCT00362336|Secondary|Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.|Day 0 up to Day 7 post each dose|Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received - Safety Analysis Population.||Participants|||Number
152796|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 540 pre-booster and Day 570, post-booster|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
152808|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
152797|NCT00362336|Secondary|Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.|Day 540 pre-booster and Day 570 post-booster|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
152798|NCT00362336|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.|Day 42 before Dose 1 and 1 month post-Dose 3|GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Titers||95% Confidence Interval|Geometric Mean
152799|NCT00362336|Secondary|Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
152800|NCT00362336|Primary|Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)|Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).|1 month post-Dose 3|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).||Participants|||Number
152801|NCT00362297|Secondary|Number of Herpes Recurrences, Defined Clinically as >=1 Successive Day on Which Genital Lesions Are Present, in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks||||||
152802|NCT00362297|Secondary|Frequency of Lesional Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per Day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks||||||
152803|NCT00362297|Secondary|Frequency of Subclinical Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.||15 weeks||||||
152804|NCT00362297|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.|Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression.|15 weeks|Participants who did not collect at least one swab on each arm of the cross-over were excluded from analysis.||percentage of swabs with HSV detected|||Number
152805|NCT00362232|Secondary|Treatment-emergent Major Bleedings Per Safety Population.|Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)|from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).|The safety population comprised those subjects who received at least 1 dose of study drug.||percentage of participants|||Number
152806|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
152807|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
152809|NCT00362232|Secondary|Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
152810|NCT00362232|Secondary|The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions|Up to 47 days after surgery|The net clinical benefit population comprised all subjects either valid for MITT analysis of major VTE or who showed treatment-emergent major bleeding.||percentage of participants|||Number
152811|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
152812|NCT00362232|Secondary|Incidence of Symptomatic VTE During Follow-up Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 47 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
152813|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
152814|NCT00362232|Secondary|Incidence of DVT (Proximal, Distal) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
152815|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
152816|NCT00362232|Secondary|Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations||percentage of participants|||Number
152817|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||percentage of participants|||Number
152818|NCT00362232|Secondary|Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.||percentage of participants|||Number
153027|NCT00360360|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||months||95% Confidence Interval|Median
152819|NCT00362232|Primary|Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism||Percentage of participants|||Number
152820|NCT00362232|Primary|Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population|Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography|Up to 16 days after surgery|The primary efficacy analysis was based on the per protocol (PP) population and included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.||Percentage of participants|||Number
152821|NCT00362180|Secondary|Percent Change in Total Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.||percent change||Inter-Quartile Range|Median
152822|NCT00362180|Secondary|Baseline Total Cholesterol|Samples were taken following an overnight fast.|Baseline|Full analysis set||mg/wk||Inter-Quartile Range|Median
152823|NCT00362180|Secondary|Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.||percent change||Inter-Quartile Range|Median
152824|NCT00362180|Secondary|Baseline Low-Density Lipoprotein Cholesterol|Samples were taken following overnight fast.|Baseline|Full analysis set||mg/wk||Inter-Quartile Range|Median
152825|NCT00362180|Secondary|Percent Change in Apolipoprotein B From Baseline to Day 99|Samples were taken following an overnight fast.|Day 26 and Day 99|Full analysis set with last observation carried forward.||percent change||Inter-Quartile Range|Median
152826|NCT00362180|Secondary|Baseline Apolipoprotein B|Samples were taken following an overnight fast.|Baseline|Full analysis set||mg/wk||Inter-Quartile Range|Median
152827|NCT00362180|Primary|Change From Baseline in Liver Triglyceride (TG) Content As Measured by Magnetic Resonance Spectroscopy (MRS)|Localized proton MRS was used to quantify liver TG concentration. All MRS imaging of the liver was performed using the same 1.5T scanner. The instructions were to cover the entire liver (from just above the dome to just below the inferior tip) using a qualified imaging technique (Yokoo, 2009, Radiology). Liver fat quantification was performed by determining the liver fat fraction (%) derived from MRS using selected Regions of Interest (ROI). The analyst typically looked for the branching of the right portal vein and mapped slices from one scan to the next. There were typically 2 ROIs in the right lobe and 1 in the left lobe. Magnetic resonance spectroscopy imaging ROIs between different scans were selected using anatomical landmarks for both time points.|Baseline, Day 26, Day 99|Full analysis set. In Cohort E: Placebo, Day 99 N=11 instead of 10 because participant did not have a post treatment MRS by Day 26.||percentage of total liver content||Full Range|Median
152828|NCT00362128|Primary|Number of Participants With Cardiovascular Risk Factors||4 years|||participants|||Number
152829|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean diastolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152830|NCT00362115|Secondary|Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 34-36-hour mean systolic blood pressure measured at week 8 relative to the 10-12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 34 to 36 hours after dosing; the 10-12-hour mean is the average from these 2 hours after dosing.|Baseline and Week 8|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152831|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean diastolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152832|NCT00362115|Secondary|Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-36-hour mean systolic blood pressure measured at week 8 relative to the 12-hour mean measured at baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-36-hour mean is the average of all measurements recorded from 24 to 36 hours after dosing; the 12-hour mean is the average of the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152833|NCT00362115|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
153028|NCT00360334|Secondary|Severe Hypoglycemic Rate Per 30 Days|Number of severe hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set||Number of episodes per 30 days||Full Range|Median
152835|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152836|NCT00362115|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152837|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152838|NCT00362115|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152839|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152840|NCT00362115|Secondary|Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 10 to 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 10-12-hour mean is the average of all measurements recorded after dosing during these 2 hours.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152841|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152842|NCT00362115|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152843|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152844|NCT00362115|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full Analysis Set.||mmHg||Standard Error|Least Squares Mean
152845|NCT00362115|Secondary|Change From Baseline in Standing Clinic Diastolic Blood Pressure.|The change in standing clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough standing diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
152846|NCT00362115|Secondary|Change From Baseline in Standing Clinic Systolic Blood Pressure.|The change in standing clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough standing systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
152847|NCT00362115|Secondary|Change From Baseline in Sitting Clinic Systolic Blood Pressure.|The change in sitting clinic systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
152848|NCT00362115|Primary|Change From Baseline in Sitting Clinic Diastolic Blood Pressure.|The change in sitting clinic diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set with last observation carried forward.||mmHg||Standard Error|Least Squares Mean
152849|NCT00361972|Secondary|Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement|Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention.|Baseline and 6 weeks|||log (pg/mL)||Inter-Quartile Range|Median
152851|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 85|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 85 and from Day -28 to Day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
152852|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 57|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 57 and from Day -28 to Day 1|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
152853|NCT00361634|Secondary|Difference Between Percent Change in IAUC From Days -28 to 1 and Days 1 to 29|Difference in percent change between the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from Day 1 to Day 29 and from Day -28 to Day 1|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
152854|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 85|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 85 and from study day -28 to study day 1|Day -28 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
152855|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 57|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 57 and from study day -28 to study day 1.|Day -28 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
152856|NCT00361634|Secondary|Difference Between Percent Change in Ktrans From Days -28 to 1 and Days 1 to 29|Difference in percent change between synovial transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from study day 1 to study day 29 and from study day -28 to study day 1.|Day -28 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||percent change||Standard Deviation|Mean
152857|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-85|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
152858|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-57|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
152859|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Time Curve (IAUC) From Days 1-85|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 85. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
152860|NCT00361634|Primary|Percent Change in the Synovial Initial Area Under the Contrast-Tme Curve (IAUC) From Days 1-57|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 57. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
152861|NCT00361634|Primary|Percent Change in Synovial Initial Area Under the (Contrast-time) Curve (IAUC) From Days 1-29|Percent change in the synovial initial area under the contrast-time curve (IAUC) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
153029|NCT00360334|Secondary|Nocturnal Hypoglycemic Rate Per 30 Days|Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set||Number of episodes per 30 days||Inter-Quartile Range|Median
152862|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-85|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 85. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, increases in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 85|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
152863|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-57|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 57. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 57|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
152864|NCT00361634|Secondary|Percent Change in Synovial Volume From Days 1-29|Percent change in the synovial volume for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from Day 1 to Day 29. Synovial volume was evaluated by image subtraction from the T1-weighted images pre-and post-administration of the contrast agent.|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available data are included in the analysis.||Percent change||Standard Deviation|Mean
152865|NCT00361634|Primary|Percent Change in Synovial Transfer Constant (Ktrans) From Days 1-29|Percent change in transfer constant (Ktrans) for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) of the wrist from study day 1 to study day 29. Ktrans reflects contrast delivery (capillary blood flow) and transport across the vascular endothelium (capillary permeability-surface area product), with the dominant factor depending on whether delivery is flow or permeability limited. A Ktrans value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Day 1 to Day 29|Full Analysis Set, composed of all participants who had a baseline and at least one post-baseline measurement. Only participants with available Day 29 data are included in the analysis.||Percent change||Standard Deviation|Mean
152866|NCT00361595|Secondary|Change in Serum N-propeptide Type 1 Collagen (P1NP) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum n-propeptide type 1 collagen (P1NP) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months|||mcg/ml||Standard Deviation|Mean
152867|NCT00361595|Secondary|Change in Serum C-telopeptide Type 1 Collagen (CTX) (at Day 10 and Months 2, 6, 9 and 12)|Change in serum c-telopeptide type 1 collagen (CTX) (at day 10 and months 2, 6, 9 and 12. 12 month values reported based on 12 month duraton of zolendronic acid effect.|12 months|||ng/ml||Standard Deviation|Mean
152868|NCT00361595|Secondary|Change in Bone Density (Grams/cm^2) at the Total Hip at 6 and 12 Months|Change in bone density (grams/cm^2) at the total hip at 6 and 12 months. 12 month reported based on usual interval for bone density follow-up in clinical practice.|6 months and 12 months|||grams/cm^2||Standard Deviation|Mean
152869|NCT00361595|Primary|Change in Lumbar Spine BMD (Bone Mineral Density) in g/cm^2 From Baseline to Month 12 Relative to Baseline as Measured by DXA (Dual-energy X-ray Absorptiometry)||Baseline and 12 months|||grams/cm^2||Standard Deviation|Mean
152870|NCT00361569|Secondary|Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)|Any adverse event reported from the beginning of the 28-day screening through the subject's last report.|Up to Week 12|All randomized subjects who received at least one dose of study medication||Participants|||Number
152871|NCT00361569|Primary|Mean Change in Maturation Index|Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints||Index||Standard Error|Least Squares Mean
152872|NCT00361569|Primary|Mean Change in Vaginal pH|Change= Week 12 vaginal pH - Baseline vaginal pH|Baseline to Week 12|Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints||pH||Standard Error|Least Squares Mean
152873|NCT00361569|Primary|Mean Change in the Symptom Identified by the Patient to be Most Bothersome|Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.|Baseline to Week 12|Modifed Intent-to-Treat: All subjects meeting study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, randomized to treatment, received at least 1 dose of study drug, and had a baseline assessment and at least 1 post-randomization assessment of vulvovaginal atrophy consisting of all 3 co-primary efficacy endpoints||Scores on a scale||Standard Error|Least Squares Mean
152899|NCT00361257|Secondary|Change of HIV Plasma RiboNucleic Acid (RNA) Viral Load|The original scale of HIV RNA viral load is between 30 copies/mL to infinitive. The minimum score of 30 is the lowest detectable value. The summary table categorized this continuous value to a dichotomous variable (<30 copies/mL and >= 30 copies/mL).|At baseline and week 24|The summary statistics were based on observed data. No statistical analysis was conducted.||participants|||Number
152874|NCT00361504|Secondary|Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)|"The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52."|Baseline, Week 52|intent-to-treat||Scores on a Scale||Standard Deviation|Mean
152875|NCT00361504|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|52 weeks|Safety analysis set (All randomized participants who took at least one dose of study medication).||Participants|||Number
152876|NCT00361439|Secondary|Change From Baseline in Percentage of Eosinophils at 2 Weeks|"A decrease between visits signifies a reduction in inflammation.~Calculated from cytology specimens obtained by lavage."|baseline and 2 weeks|||percentage of eosinophils||Full Range|Median
152877|NCT00361439|Secondary|Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks|An increase between visits indicates improved nasal airflow.|baseline and 2 weeks|||liters per minute||Full Range|Median
152878|NCT00361439|Secondary|Change From Baseline in Total Nasal Symptom Score at 2 Weeks|A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.|baseline and 2 weeks|||units on a scale||Full Range|Median
152879|NCT00361439|Primary|Histological Findings|Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported|2 weeks|||eosinophils per HPF||Full Range|Median
152880|NCT00361374|Primary|Score on a Depression Severity Rating Scale Over Eight Weeks|Change in score on 17-item Hamilton D depression severity rating scale over 8 weeks of treatment. Scores were obtained every 2 weeks for 8 weeks. The total sum score of the 17 items is used to assess depressive severity. Possible total scores range from 0-52, with a higher score indicating greater depressive severity. Scores of 7 or less are indicative of full remission (i.e. no depression). Scores of 8-15 indicate mild depression; scores of 16-25 indicate moderate depression; scores of 25 or greater indicate severe depression. Mixed model repeated measures analysis (MMRM) was used to examine treatment group effect on changes from baseline to week 8 in Hamilton D scores. Models included subjects as a random effect, and treatment group and study week as fixed effects. An auto-regressive covariance structure was used because it provided the best fit to the data. Site and baseline score were included as covariates in all models.|8 weeks|We randomized 196 of 389 screened patients. Nineteen subjects dropped out before completing at least one post-baseline visit, leaving 177 evaluable subjects||units on a scale||Standard Error|Mean
152881|NCT00361335|Secondary|Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14|The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.|Weeks 0 to Week 14|Intent to treat (ITT). Missing components were imputed by the median component value of all patients in the same Stratum at baseline, and last observation carried forward (LOCF) at Week 14||Units on a scale||Standard Deviation|Mean
152882|NCT00361335|Secondary|Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient’s assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A “Moderate” response is defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >1.2 or a DAS28 score of <= 5.1 and improvement from baseline in DAS28 score of >0.6 to 1.2"|Week 0 to Week 14|Intent to treat. Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing components were imputed by the median component value of all patients in the same stratum unless all components are missing in which case considered non-responders.||Participants|||Number
152883|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
152884|NCT00361335|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).|Week 0 to Week 24|||Participants|||Number
152900|NCT00361257|Secondary|Number of Participants With Grade 2 or Higher Toxicity and/or Signs and Symptoms|Grade or higher means that adverse events were moderate, severe, or life-threatening, or death. Grade 2 or higher adverse events are lised in the Adverse Event section.|Throughout study up to week 48|The analysis includes all randomized participants. A total of 37 minocycline and 38 placebo participants reported Grade 2 or higher toxicity and/or signs and symptoms during 48 weeks.||participants with an event|||Number
152885|NCT00361335|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14|An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 0 to Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
152886|NCT00361283|Primary|Mean Change in Level: Week 16-baseline in Ena-78|We take difference week 16 minus week 0 for ENA-78 and use a one sample t comparison.|16 weeks after baseline|Power calculation||pg/ml||Standard Deviation|Mean
152887|NCT00361270|Secondary|Change From Pre Treatment to 1-week Post Treatment on Pittsburgh Sleep Quality Index (PSQI)|The change score is the difference between pre-treatment scores on the Pittsburgh Sleep Quality Index (PSQI) and the 1-week post-treatment scores. Positive values indicate a reduction in sleep problems. The PSQI was scored on 19 items with 7 component scores ranging from 0 no difficulty falling asleep to 3 severe difficulty, then component scores added to create global score ranging from 0 no difficulty falling asleep to 21 severe difficulty falling asleep.|Subjects change on this scale from Pre-treatment to 1-week post treatment|||units on a scale||Standard Deviation|Mean
152888|NCT00361270|Secondary|Change From Pre-treatment to 1- Week Post Treatment on Brief Pain Inventory-Interference Scale|The change score measures the difference between pre-treatment scores on the Brief Pain Inventory-Interference Scale (NRS: 0 no interference - 10 complete interference) and 1- week post treatment scores for the 10 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1-week post treatment|||units on a scale||Standard Deviation|Mean
152889|NCT00361270|Primary|Change From Pre-Treatment to 1-week Post Treatment on Brief Pain Inventory-Pain Intensity Scale|The change score measures the difference between Pre-Treatment Brief Pain Inventory Pain Intensity Scale scores (Numerical Rating Scale (NRS): 0 no pain - 10 worst pain) and the 1-week Post--Treatment Brief Pain Inventory-Pain Intensity Scale scores for 4 items. Change is calculated as pre-treatment minus post treatment.|Subjects change on this scale from Pre-Treatment to 1 week post treatment|||units on a scale||Standard Deviation|Mean
152890|NCT00361257|Secondary|Changes in Alternate Frontal Systems Z-Score|The alternate frontal systems was defined as a mean of age and education adjusted z score of Interference task, and age, sex, education, and African-American ethnicity adjusted z score of Trail Making Part B. The outcome was the 24 week change in alternate frontal systems z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
152891|NCT00361257|Secondary|Changes in Alternate Verbal Memory Z-Score|The alternate verbal memory was defined as a mean of age and education adjusted z score of trials 1 to 3 and delayed recall tests. The outcome is the 24 week change in alternate verbal memory z-score (week 24-baseline).|At baseline and week 24|The analysis is based on observed data.||z-score||Standard Deviation|Mean
152892|NCT00361257|Secondary|Changes in Alternate Psychomotor Function Z-Score|The alternate psychomotor function is defined as the mean of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA), and age and education adjusted z score of Symbol Digit (SYD). The outcome is the 24 week change in alternate psychomotor function z-score (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.||z-score||Standard Deviation|Mean
152893|NCT00361257|Secondary|Changes in Neurotransmitter Levels (Unit = uM Only)|Neurotransmitter levels (Glutamate, Tryptophan, Anthranilic Acid, Quinolinic Acid, Kynurenin, and 3-Hydroxykynurenine). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||uM||Inter-Quartile Range|Median
152894|NCT00361257|Secondary|Changes in Markers of Oxidative Stress (Unit = Pixels/mm2 Only)|Protein marker of oxidative stress (Neurofilament heavy polypeptide). The outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||Pixels/mm^2||Inter-Quartile Range|Median
152895|NCT00361257|Secondary|Changes in Markers of Oxidative Stress and Immune Activation (Unit=pg/mL Only)|Protein markers of oxidative stress (Protein carbonyls) and markers of immune activation (TNF-a, IL-6,CXCL8, Hepatocyte growth factor, Osteopontin, sFAS, sFAS ligand, and CXCL12). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||pg/mL||Inter-Quartile Range|Median
152896|NCT00361257|Secondary|Changes in Protein Markers of Oxidative Stress (Unit = Counts Per Second Only)|Protein marker of oxidative stress (Ceramides, Monohexosylceramides, Dihydro Glycosyl Galceramides, and Dihexosylceramides). For all markers, the outcome is the 24 week change (week 24-baseline).|At pre-entry and Week 24|Participants who were willing to receive the lumber punctures at week 0 and 24.||counts per second||Inter-Quartile Range|Median
152897|NCT00361257|Secondary|Changes in Medication Management Test (Modified)|The medication management test (modified) is designed to assess participants' medication management ability and their own medications and management. It’s the number of how many times participants correctly answered 16 questions. The score ranges between 0 and 16, and higher score indicates better medication management.|At baseline and weeks 24|The analysis was based on observed data.||scores on a scale||Standard Deviation|Mean
152898|NCT00361257|Secondary|Changes in Instrumental Activities of Daily Living Questionnaire|The Instrumental Activities of Daily Living (IADL) questionnaire is designed to learn more about how subjects are able to perform common tasks. There are 16 common tasks. For each task, if the score at the time of evaluation is worse than the best in the past, an indicator of 1 is given. Otherwise, the indicator is 0. The overall IADL score is a sum of 16 indicators divided by 16; therefore, the range is between 0 and 1 and the lower score is better. The 24-week change of IADL score was changed into a categorical variable (no change/worse vs. better) at week 24 compare to baseline.|At baseline and week 24|The analysis was based on observed data.||participants|||Number
152903|NCT00361257|Secondary|Change in Karnofsky Performance Score|"The original Karnofsky performance score is 11 level score which ranges between 0 to 100. The score 100 means normal and 0 means death; therefore, higher score means higher ability to perform daily tasks.~For the analysis, a new dichotomous variable (no change/worse vs. better at 24 weeks compared to baseline) was created."|At baseline and week 24|The analysis was based on observed data.||participants|||Number
152904|NCT00361257|Secondary|Change in Frontal Systems Function Domain Z-Score|The frontal systems function domain score is the average of age and education adjusted z scores of Stroop Color Interference Test (CTP) and interference task (STP). The outcome is the 24 week change of frontal systems function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
152905|NCT00361257|Secondary|Change in Verbal Memory Domain Z-Score|The verbal memory domain score is the average of age and education adjusted z scores of Hopkins Verbal Learning Test- Revised, Learning and Delayed Recall. The outcome is the 24 week change of verbal memory domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
152906|NCT00361257|Secondary|Change in Information Processing Function Domain Z-Score|The information processing function domain score is the average of age and education adjusted z scores of simple and sequential reaction time - CalCAP. The outcome is the 24 week change of information processing function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
152907|NCT00361257|Secondary|Change in Fine Motor/Nonverbal Function Domain Z-Score|The fine motor/nonverbal function domain score is a age and education adjusted z score of Symbol Digit Test (SYD) The outcome is the 24 change of fine motor/nonverbal function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
152908|NCT00361257|Secondary|Change in Psychomotor Function Domain Z-Score|The psychomotor function domain score us the average of age, sex, education, and African-American ethnicity adjusted z scores of Trail Making Part A (TMA) and Trail Making Part B (TMB). The outcome is the 24 week change of psychomotor function domain z-scores (week24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
152909|NCT00361257|Secondary|Change in Fine Motor Function Domain Z-Score|The fine motor function domain score is an average of age, sex, education, and African-American ethnicity adjusted z scores of Grooved Pegboard Dominant Hand (GPD) and Grooved Pegboard Non-dominant hand (GPN). The outcome is a 24 week change of the fine motor function domain z-score (week 24-baseline).|At baseline and week 24|The analysis was based on observed data.||z-score||Standard Deviation|Mean
152910|NCT00361257|Secondary|Change in Cognitive Gross Motor Function Domain Z-Score|The cognitive gross motor function is a age and education adjusted z score of Timed Gait (TIG). The outcome is the 24 week change of cognitive gross motor function domain z-scores (week 24-baseline).|At baseline and week 24|The analysis was based on the observed data.||z-score||Standard Deviation|Mean
152911|NCT00361257|Secondary|Change in Investigator's Clinical Global Impression Score (ICGIS)|"Clinicians were asked to rate their overall impression about the clinical improvement or worsening of his/her study participants. They can choose from the following 7 levels: (0) No Change, (1) Mild Improvement, (2) Moderate Improvement, (3) Marked Improvement, (4) Mild Worsening, (5) Moderate Worsening, and (6) Marked Worsening.~For the analysis, we simplified the outcome into the following 3 levels: (0) worsened, (1) No Change, and (2) Improved."|At week 24|The analysis was based on observed data.||participants|||Number
152912|NCT00361257|Secondary|Change in Global Deficit Z-Score (GDS)|GDS on the test battery is the simple average of all 14 individual deficit scores in the test battery, including Time Gait, Grooved Pegboard Test for the dominant and non-dominant hands, Trail Making Test parts A and B, Symbol Digit Test, simple and sequential reaction time - CalCAP, Hopkins Verbal Learning Test (Revised)- Learning, Delayed Recall and Recognition trials, and Stroop Color Interference Test-color, word, and interference tasks. The outcome is the 24 week change of GDS Z-score (24 week-baseline).|At baseline and week 24|The analysis was based on the observed data.||z-score||Standard Deviation|Mean
152913|NCT00361257|Primary|Change in Cognitive Performance Compared to Baseline|"Th cognitive performance is measured by NPZ-8. NPZ-8 is defined as the average of age and education adjusted z-scores of eight neuropsychological tests subcomponents in the neuropsychological test battery. These eight tests are:~Grooved Pegboard Dominant Hand (GPD)~Grooved Pegboard Non-dominant hand (GPN)~Choice Reaction Time (CRT)~Sequential Reaction Time (QRT)~Timed Gait (TIG)~Trail Making Part A (TMA)~Trail Making Part B (TMB)~Symbol Digit (SYD) The primary outcome is NPZ-8 score at week24 - NPZ-8 score at baseline."|At baseline and week 24|The descriptive statistics above were based on the observed data; however, the statistical analysis was conducted by the ITT analysis and the missing outcomes at week 24 were imputed based on multiple regression imputations.||z-score||Standard Deviation|Mean
152914|NCT00361231|Secondary|Overall Response Rate|To assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|||percentage of participants|||Number
152915|NCT00361231|Primary|Median Progression Free Survival|To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.|2 years|||months||95% Confidence Interval|Median
152916|NCT00361218|Primary|Serum Brain-derived Neurotrophic Factor (BDNF) Levels||8 weeks|||pg/mL||Standard Deviation|Mean
152917|NCT00361218|Primary|Quantitative Electroencephalogram Measurements||8 weeks||||||
152918|NCT00361140|Primary|Non-relapse Mortality|The number of subjects dead due to causes unrelated to relapse within the first 100 days post transplant|100 days|Intent to treat||participants|||Number
153030|NCT00360334|Secondary|Hypoglycemic Rate Per 30 Days|Number of hypoglycemic episodes per patient adjusted per 30 days|26 weeks|Full Analysis Set||Number of episodes per 30 days||Inter-Quartile Range|Median
153031|NCT00360334|Secondary|Incidence of Severe Hypoglycemic Episodes|Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study|26 weeks|Full Analysis Set||percent|||Number
152919|NCT00361140|Secondary|Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)|"The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald GB, Hinds MS, Fisher LD, et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation:~a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant"|100 days|Intent to treat||participants|||Number
152920|NCT00360971|Secondary|Time to Second Primary Tumor|Second primary tumors other than basal cell will be considered.|From registration to 10 years.||||||
152921|NCT00360971|Secondary|Progression-free Survival||From registration to 10 years.||||||
152922|NCT00360971|Secondary|Overall Survival||From registration to 10 years.||||||
152923|NCT00360971|Secondary|Time to Onset of Mucositis as Measured by the World Heath Organization (WHO) Scale||From the start of treatment to 15 weeks||||||
152924|NCT00360971|Secondary|Incidence of Mucositis as Measured by the World Heath Organization (WHO) Scale||From the start of treatment to 15 weeks||||||
152925|NCT00360971|Primary|Duration of Oral Mucositis as Measured in Terms of Days|"Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days [15 weeks] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0.~This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05.~Statistical testing was not done due to the small sample size."|From the start of treatment to 15 weeks|All eligible patients.||Days||Standard Deviation|Mean
152926|NCT00360828|Secondary|Overall Survival at 12 Months|Patients surviving 12 months after last dose of drug|12 months post treatment end|All participants who received at least one dose of drug||participants|||Number
152927|NCT00360828|Secondary|Frequency and Severity of Toxicity|Toxicities assessed through 3 months|3 months|The low accrual rate prevented us from completing the planned analysis.||participants|||Number
152928|NCT00360828|Secondary|Progression Free Survival|Patients surviving at one year post treatment end|1 year post treatment end|The low accrual rate prevented us from completing the planned analysis.||participants|||Number
152929|NCT00360828|Secondary|Overall Survival at 6 Months|Patients surviving 6 months after treatment end|6 months post treatment end|All participants who received at least one dose of drug||participants|||Number
152930|NCT00360828|Primary|Number of Participants With Objective Response After 3 Cycles of Treatment|The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.|3 cycles (21 day cycles)|All participants having stable disease||participants|||Number
152931|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information"|Baseline|subjects for whom post-baseline data were available||points on rating scale||Standard Deviation|Mean
152932|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|Baseline|subjects for whom post-baseline data was available||Scores on a scale||Standard Deviation|Mean
152933|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression"|Baseline|subjects for whom data post baseline were available||Scores on a scale||Standard Deviation|Mean
152934|NCT00360724|Secondary|Magnetic Resonance Spectroscopic Imaging (MRSI)|Magnetic resonance spectroscopic imaging. We expect to find decreased levels of N-Acetyl-Aspartate (NAA) in frontal cortex (dorsal prefrontal, subgenual prefrontal cortex, and orbitofrontal cortex gray matter), as well as in hippocampus, amygdala, caudate, and putamen.|10 weeks||12/2016||||
152935|NCT00360724|Secondary|Magnetic Resonance Imaging, Functional (fMRI)|"Functional brain imaging tests, including measures of cognitive conflict (Simon Task) and affective activation (Affective circumplex task) fMRI~a. Simon Task: i. We expect reduced frontal cortex activation in depressed subjects, and ii. normalization of frontal cortex activation following treatment. b. Affective Circumplex Task: i. Reduced amygdala and hippocampal activation in depressed subjects, ii. normalization of activation in these areas following treatment."|10 weeks||12/2016||||
152936|NCT00360724|Secondary|Clinical Global Impressions Improvement(CGI-I)|"The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline.~0 = Not assessed~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse Higher score=greatest worsening"|10 weeks|subjects for whom post-baseline data was available||Scores on a scale||Standard Deviation|Mean
153032|NCT00360334|Secondary|Incidence of Nocturnal Hypoglycemic Episodes|Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set||percent|||Number
152937|NCT00360724|Secondary|Magnetic Resonance Imaging, Anatomical|"Chronic depression vs. normal differences: we expect to find abnormal brain region volumes in several regions compared to norms. Specifically: Frontal Cortex: decreased dorsal prefrontal volume, and reduced grey matter in subgenual prefrontal cortex; reduced orbitofrontal cortex gray matter volume; decreased hippocampal volume; decreased amygdala volume; decreased caudate volume; decreased putamen volume~treatment vs. placebo differences: following active treatment, we hypothesize that volumes will change in the direction of normal in the hippocampus, prefrontal cortex, subgenual cortex, and amygdala~responder vs. non-responder differences: greater changes in the areas found in hypothesis 2 are expected in treatment responders compared to non-responders"|10 weeks, 22 weeks||||||
152938|NCT00360724|Secondary|Beck Depression Inventory (BDI)|"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.~When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[7]~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|Week 10|subjects fro whom post-baseline data was available||Scores on a scale||Standard Deviation|Mean
152939|NCT00360724|Secondary|Global Assessment of Functioning Scale (GAF)|"A commonly used rating scale for global social function.~Range from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).~61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others~1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.~0 Inadequate information"|Week 10|subjects for whom post-baseline data were available||points on rating scale||Standard Deviation|Mean
152940|NCT00360724|Secondary|Cornell Dysthymia Rating Scale (CDRS)|"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).~Scores from 0 to 82 with higher score indicating worse depression"|Week 10|subjects for whom data post baseline were available||scores on a scale||Standard Deviation|Mean
152941|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Baseline|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.||Scores on a scale||Standard Deviation|Mean
152942|NCT00360724|Primary|Hamilton Depression Rating Scale (HDRS) - 24 Total Score|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Week 10|Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.||Scores on a scale||Standard Deviation|Mean
152943|NCT00360698|Secondary|Rate of Severe Symptomatic Hypoglycemia||during treatment period (12 weeks)|Safety population||Number of hypoglycemia per patient-year||Standard Deviation|Mean
152944|NCT00360698|Secondary|Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population||Number of hypoglycemia per patient-year||Standard Deviation|Mean
152945|NCT00360698|Secondary|Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL||during treatment period (12 weeks)|Safety population||Number of hypoglycemia per patient-year||Standard Deviation|Mean
152946|NCT00360698|Secondary|Daily Dose of Insulin Glulisine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF||units of insulin glulisine per day||Standard Deviation|Mean
152947|NCT00360698|Secondary|Daily Dose of Insulin Glargine|Mean of 3 daily doses reported during the week prior to the final visit|at the end of treatment (week 24)|Modified ITT population, LOCF||units of insulin glargine per day||Standard Deviation|Mean
152948|NCT00360698|Secondary|Change in Weight||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF||kg||Standard Error|Least Squares Mean
152949|NCT00360698|Secondary|Change in Daily Mean Plasma Glucose||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF||mg/dL||Standard Error|Least Squares Mean
152950|NCT00360698|Secondary|Daily Mean Plasma Glucose||at the end of treatment (week 24)|Modified ITT population, LOCF||mg/dL||Standard Deviation|Mean
152951|NCT00360698|Secondary|Change in Glycosylated Haemoglobin (HbA1c) Value||from baseline to the end of treatment (week 24)|Modified ITT population, LOCF||percent||Standard Error|Least Squares Mean
152952|NCT00360698|Secondary|Glycosylated Haemoglobin (HbA1c) Value||at the end of treatment (week 24)|Modified ITT population, LOCF||percent||Standard Deviation|Mean
152953|NCT00360698|Primary|Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%|Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%|at the end of treatment (week 24)|Modified Intent to treat (ITT) population, LOCF (Last Observation Carried Forward)||percentage of participants|||Number
152954|NCT00360685|Secondary|Overall Survival|number of participants alive at one year|1 year|intent to treat||participants|||Number
152955|NCT00360685|Secondary|Incidence of Acute Graft-vs-host Disease (aGVHD)|incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation|100 days post transplant|intent to treat||participants|||Number
152956|NCT00360685|Primary|Incidence of Severe Mucositis|Mucositis was assessed prospectively daily while the patient was hospitalized and graded retrospectively based on nurse and clinician assessments according to the clinical criteria set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0). Severe mucositis as defined as grade 3 or grade 4.|2 year|Intent to treat||participants|||Number
152957|NCT00360672|Primary|Number of Participants With a Response (Complete Remissions (CR), Complete Remissions With Incomplete Platelet Recovery [CRp] and Partial Responses)|Response for Acute Myeloid Leukemia (AML) according to 2003 International Working Group (IWG) criteria: CR required absolute neutrophil count (ANC) >1 * 10^9/L, platelet count ≥100 * 10^9/L, < 5% of blast cells in bone marrow. CRp: as above except platelet count <100 * 10^9/L. Partial remission: as CR except for presence of 5-25% marrow blasts and with a decrease of marrow blast at least 50%. Response for Myelodysplastic Syndrome (MDS) was defined based on the 2006 IWG criteria. All participants with MDS who achieved hematological CR, Partial Response (PR), marrow CR, and hematological improvement considered responders.|Following three 28-day cycles evaluated for response|||participants|||Number
152958|NCT00360568|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (Month 12 months or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152959|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0–100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152960|NCT00360568|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152961|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152962|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152963|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152964|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
153033|NCT00360334|Secondary|Incidence of Hypoglycemic Episodes|Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study|26 weeks|Full Analysis Set||percent|||Number
152965|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152966|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152967|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152968|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152969|NCT00360568|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152970|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152971|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152972|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152973|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152974|NCT00360568|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
152975|NCT00360568|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment; n=number of participants with assessment at timepoint.||units on a scale||Standard Deviation|Mean
152976|NCT00360568|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Month 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. “On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Deviation|Mean
152977|NCT00360568|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Deviation|Mean
152978|NCT00360568|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Full Analysis Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Deviation|Mean
152979|NCT00360568|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include medications started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
152980|NCT00360568|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS) Findings|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187-3-3003 LCIG infusion with a C-SSRS assessment during the study.||participants|||Number
153013|NCT00360490|Secondary|Percent Change From Baseline MBL to End of Study MBL (Cycle 6)|The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||Percent change||Standard Deviation|Mean
153034|NCT00360334|Secondary|Change in Apolipoprotein-B|Change in apolipoprotein-B from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||g/L||Standard Error|Least Squares Mean
152981|NCT00360568|Primary|Number of Participants With Clinically Significant Neurological Examination Findings|"The neurologic examination was to be done during On time. The neurological examination assessed: cranial nerves – assessment of cranial nerves II – XII, excluding fundoscopic examination; motor system – assessment of tone, strength, and abnormal movements; sensory system – including light touch, pinprick, joint position, and vibratory sense; reflexes – assessment of deep tendon reflexes and plantar responses (Babinski sign); coordination – assessment of upper and lower extremities; gait – assessment of base and tandem gait; station – assessment of posture and stability."|up to 12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had a neurological examination.||participants|||Number
152982|NCT00360568|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination/end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|up to Month 12|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
152983|NCT00360568|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions concerning problems with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.||units on a scale||Standard Deviation|Mean
152984|NCT00360568|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire-setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, Post-baseline (up to Month 12)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment at timepoint.||participants|||Number
152985|NCT00360568|Primary|Number of Participants With Sleep Attacks at Baseline and Endpoint|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness.|Baseline, Endpoint (Month 12 or last post-baseline visit)|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
152986|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
152987|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with assessment.||participants|||Number
152988|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion; n=number of participants with an assessment.||participants|||Number
152989|NCT00360568|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f) and males (m).|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion and had an assessment.||participants|||Number
152990|NCT00360568|Primary|Number of Participants With Device Complications|Complications of the infusion device were collected. Pump, intestinal tube, PEG, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and device site reaction.|12 months|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
152991|NCT00360568|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.|Safety Data Set: all enrolled participants who received at least one study S187.3.003 LCIG infusion.||participants|||Number
152992|NCT00360555|Primary|Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit.” Potential responses included no, “low,” “moderate,” or “strong” and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:~0 = No desire~= Low desire~= Moderate desire~= Strong desire"|baseline to 24 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.||units on a scale||Standard Error|Least Squares Mean
152993|NCT00360555|Primary|Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.|"For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms.~For satisfying sexual events:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)"|baseline to 28 weeks|Participants who received at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). Efficacy endpoints were analyzed primarily using the FAS.||SSEs per 28 days||Standard Deviation|Mean
152994|NCT00360529|Secondary|Patient Benefit Evaluation|The Patient Benefit Evaluation is a single question asking the patient whether or not she experienced a meaningful benefit from the study medication during the trial. This question (“Overall, do you believe that you have experienced a meaningful benefit from the study medication?”) was asked upon treatment discontinuation.|Week 24|This question was asked at Week 24 only, so did not include participants who had discontinued the trial prior to that time (e.g., analysis population includes treatment completers only).||participants|||Number
152995|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit|The FSFI© is a self-administered questionnaire to assess FSD, which consists of 19 questions that are scored from ‘0’ to ‘5.’ The scale contains six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate higher levels of the domain assessed. The total score is a weighted average of the six domains, each contributing a maximum of 6 points to the total, so the minimum score is 2, while the maximum score of FSFI© is 36.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
152996|NCT00360529|Secondary|Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit|Female Sexual Function Inventory (FSFI) Desire Domain assesses sexual desire or interest with 2 questions ranging from 1 (very low) to 5 (very high). The domain total score is multiplied by 0.6 yielding scores ranging from 1.2 to 6 (higher scores = higher level of desire or interest).|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
152997|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit|Change from baseline in the FSDS-R Question 13 (Bothered by low sexual desire). The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The scoring for item 13 is from 0-4, with 4 indicating the highest level of sexual distress.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
152998|NCT00360529|Secondary|Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit|"Change from baseline in the Female Sexual Distress Scale - revised (FSDS-R) Total Score with a seven day recall period.~The FSDS is a measure of female personal distress associated with sexual dysfunction. Reliability and validity of the FSDS (12-item version) has been evaluated in different samples of sexually functional and dysfunctional women. An additional question (Question 13) was added to the validated FSDS© in order to capture distress related to specifically sexual desire so that this domain could be appropriately captured. FSDS plus Question 13 comprises FSDS-R, thus making the FSDS-R a self-administered 13 item questionnaire. The maximum total score of the FSDS-R is ‘52’ (score of minimum of 0 and maximum of 4 for each item) and indicates the maximum level of sexual distress (the higher the score, the higher the level of reported sexual desire)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||score on a scale||Standard Error|Least Squares Mean
153014|NCT00360490|Primary|Percentage of Patients With Successful Treatment|End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.|At 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||Percentage of participants|||Number
153035|NCT00360334|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
153036|NCT00360334|Secondary|Change in Fasting Serum Triglycerides|Change in fasting serum triglycerides from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
152999|NCT00360529|Primary|Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit|"Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours/since your last visit.” Potential responses included no, “low,” “moderate,” or “strong, scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire):~0 = No desire~= Low desire~= Moderate desire~= Strong desire~Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses)."|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Least Squares Mean
153000|NCT00360529|Primary|Satisfying Sexual Event Monthly Change From Baseline at Final Visit|Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.|Baseline, Week 24|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||number of events||Standard Deviation|Mean
153001|NCT00360490|Secondary|Percentage of Patients With Improvement in the Patients Overall Assessment Scale|“Improved” is classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” is classified as ‘no change’, ‘worse’, ‘much worse’, or ‘very much worse’.|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.||percentage|||Number
153002|NCT00360490|Secondary|Percentage of Patients With Improvement in the Investigator Global Assessment Scale|“Improved” is classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” is classified as ‘no change’, ‘worse’, ‘much worse’, or ‘very much worse’|Up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (78 for LNG IUS and 82 for MPA) were available for the analysis.||percentage|||Number
153003|NCT00360490|Secondary|Percent Change in Serum Ferritin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 148 subjects (75 for LNG IUS and 73 for MPA) were available for the analysis.||percent change||Full Range|Median
153004|NCT00360490|Secondary|Percent Change in Hematocrit||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.||percent change||Full Range|Median
153005|NCT00360490|Secondary|Percent Change in Hemoglobin||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 150 subjects (75 for LNG IUS and 75 for MPA) were available for the analysis.||percent change||Full Range|Median
153006|NCT00360490|Secondary|Total Number of Bleeding Episodes|A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||number of bleeding episodes||Standard Deviation|Mean
153007|NCT00360490|Secondary|Total Number of Spotting Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||days||Standard Deviation|Mean
153008|NCT00360490|Secondary|Total Number of Spotting and Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||days||Standard Deviation|Mean
153009|NCT00360490|Secondary|Total Number of Bleeding Days|In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 163 subjects (81 for LNG IUS and 82 for MPA) were available for the analysis.||days||Standard Deviation|Mean
153010|NCT00360490|Secondary|Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group||Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis.||percentage of participants|||Number
153011|NCT00360490|Secondary|Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)|The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||Percent change||Standard Deviation|Mean
153012|NCT00360490|Secondary|Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.|Baseline and up to 3 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||milliliter (mL)||Full Range|Median
153037|NCT00360334|Secondary|Change in TC to HDL Cholesterol Ratio|Change in TC to HDL cholesterol ratio from baseline to endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward||Ratio||Standard Error|Least Squares Mean
153015|NCT00360490|Primary|The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)|The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.|Baseline and up to 6 months|Among of the 165 Full Analysis Set (FAS) subjects, a total of 160 subjects (79 for LNG IUS and 81 for MPA) were available for the analysis. One subject in LNG IUS, and two subjects in MPA group were not available due to the missing of diary data, and 2 subjects in LNG IUS group were not available due to the invalid baseline data.||milliliter (mL)||Full Range|Median
153016|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population||Scores on a scale||Standard Deviation|Mean
153017|NCT00360412|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study|Unified Parkinson’s Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson’s Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population||Scores on a scale||Standard Deviation|Mean
153018|NCT00360412|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population||Hours||Standard Deviation|Mean
153019|NCT00360412|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68|Safety Population- all subjects entering the open-label extension study who took at least 1 dose of perampanel||Hours||Standard Deviation|Mean
153020|NCT00360399|Secondary|Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy|The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks|Measured after 12 weeks of combined treatment|Participants who did not achieve remission during monotherapy were offered 12 weeks of combination therapy. This sample consists of those participants who consented for the combination therapy part of the trial and who completed the 12 weeks of treatment.||participants|||Number
153021|NCT00360399|Secondary|Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment|The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive.|Measured at 6, 9, 12, 15, 18, 21, and 24 months|This population is comprised of participants who completed 12 weeks of treatment, achieved remission, and participated in a follow-up phase that lasted for up to 21 months or until recurrence occurred.||participants|||Number
153022|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7"|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.||participants|||Number
153023|NCT00360399|Secondary|Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample|"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7"|Up to 12 Weeks|The population is defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment.||participants|||Number
153024|NCT00360399|Primary|Remission From Major Depressive Episode Among Participants Who Completed the Intervention|The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression.|Measured at Weeks 10 and 12|This population includes participants who completed the trial, per study protocol.||percentage of participants|||Number
153025|NCT00360399|Primary|Remission From Major Depressive Episode in Intent to Treat Sample|The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression.|Up to 12 Weeks|This population consists of all participants who were randomized and returned for at least one study visit. This population was used for the intent to treat analyses and not all of these individuals completed the study.||percentage of participants|||Number
153042|NCT00360334|Secondary|Percent of Patients Achieving 10% Weight Loss|Percent of patients who lost at least 10% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.||Percentage of participants|||Number
153043|NCT00360334|Secondary|Percent of Patients Achieving 5% Weight Loss|Percent of patients who lost at least 5% of baseline body weight at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.||Percentage of participants|||Number
153044|NCT00360334|Secondary|Percent Change in Body Weight|Percent change in baseline body weight at endpoint|26 Weeks|Full Analysis Set||Percentage||Standard Error|Least Squares Mean
153045|NCT00360334|Secondary|Change in Body Weight|Change in body weight from baseline to endpoint|26 weeks|Full Analysis Set||kg||Standard Error|Least Squares Mean
153046|NCT00360334|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio from baseline to endpoint|26 weeks|Full Analysis Set||Ratio||Standard Error|Least Squares Mean
153047|NCT00360334|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to endpoint|26 Weeks|Full Analysis Set||cm||Standard Error|Least Squares Mean
153048|NCT00360334|Secondary|Change in Body Mass Index (BMI)|Change in BMI from baseline to endpoint|26 weeks|Full Analysis Set||kg/m^2||Standard Error|Least Squares Mean
153049|NCT00360334|Secondary|Change in 7 Point Self Monitored Blood Glucose Profile|Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Deviation|Mean
153050|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 6.5%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.||Percentage of participants|||Number
153051|NCT00360334|Secondary|Percent of Patients Achieving HbA1c < 7%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.||Percentage of participants|||Number
153052|NCT00360334|Secondary|Percent of Patients Achieving HbA1c ≤ 7.4%|Percent of patients achieving specified HbA1c target at endpoint|26 weeks|Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.||Percentage of participants|||Number
153053|NCT00360334|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)|26 weeks|Full Analysis Set, Last Observation Carried Forward||mmol/L||Standard Error|Least Squares Mean
153054|NCT00360334|Secondary|Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.||Percentage of participants|||Number
153055|NCT00360334|Primary|Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)|Composite endpoint evaluating effect of treatment on glycemic control and weight|26 weeks|Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.||percentage of participants|||Number
153056|NCT00360308|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population||Hours||95% Confidence Interval|Least Squares Mean
153057|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
153058|NCT00360308|Secondary|Mean Change From Baseline in UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|ITT Population||Scores on a scale||95% Confidence Interval|Least Squares Mean
153059|NCT00360308|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 18 (Including LOCF Data)|Efficacy assessments were recorded by subjects using a home diary card. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.|Baseline and Week 18|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.||Hours||95% Confidence Interval|Least Squares Mean
153080|NCT00359983|Secondary|Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
153060|NCT00360282|Secondary|Change From Baseline in Subjective Units of Distress to Post Vestibular Stimulus|Subjective report of distress ranging from 0 to 10 based on the method of Wolpe. Zero indicates no distress and 10 indicates severe distress. Measures used in this analysis match the times used in the analysis for Outcome 1.|Pre and Post Stimulus (6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.||units on a scale||Inter-Quartile Range|Median
153061|NCT00360282|Primary|Change From Baseline in Motion Sickness to Post Vestibular Stimulus|Scores are based on a scale developed by Graybiel which rates seven subjective and objective signs of motion sickness. The total scores ranged from from 0 to 25. Zero indicating no motion sickness. Greater than 16 indicates severe motion sickness. Trials were stopped if scores were 16 or greater. Scores were taken before and after each rotation.|Pre and Post Stimulus (about 6 minutes apart)|Ten of the 25 subjects who completed both experimental visits developed negligible motion sickness induced by the stimulus following pre-medication with placebo. These data were not analyzed. It was posited that the presence/absence of vertigo would not impact the analysis of this outcome. The groups were combined for the analysis.||units on a scale||Inter-Quartile Range|Median
153062|NCT00360269|Secondary|Clinical Global Impression, Improvement Scale|The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|12 weeks|||Units on a scale||Standard Deviation|Mean
153063|NCT00360269|Secondary|Wender-Reimherr Adult Attention Deficit Disorder Scale|The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0–2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF).|Baseline and Week 12|||Units on a scale||Standard Deviation|Mean
153064|NCT00360269|Secondary|Urine Drug Screens|Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.|12 weeks|||Percentage of positive UDS|||Number
153065|NCT00360269|Primary|Estimated Week 12 Self-reported Use|Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.|One week (study week 12)|||Times per day||Standard Error|Mean
153066|NCT00360269|Secondary|Self-reported Longitudinal Use|Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back.|12 weeks|||Percentage of days used||Standard Deviation|Mean
153067|NCT00360243|Primary|Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.|"Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (total score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read Indicate your most intense level of sexual desire in the last 24 hours / since your last visit.” Potential responses included no, “low,” “moderate,” or “strong” and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:~0 = No desire~= Low desire~= Moderate desire~= Strong desire"|baseline to 24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||units on a scale||Standard Error|Least Squares Mean
153068|NCT00360243|Primary|Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.|A small personal handheld electronic device (eDiary) was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The FAS was analyzed for efficacy.||SSEs per week||Standard Deviation|Mean
153069|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tired State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153070|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Tense State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153164|NCT00359788|Secondary|FVC at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153071|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Sad State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153072|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Happy State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153073|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Energetic State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153074|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Confused State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153075|NCT00360009|Primary|Change in Visual Analogue Mood Scales (VAMS) Afraid State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153076|NCT00360009|Secondary|Change in Letter Fluency Tasks (LFT)|LFT assess frontal lobe function. Performance measure is number of words beginning with a specific letter generated in 1 min. Although no range of possible scores,the more words named in allotted time,the higher the predicted frontal lobe function. Raw score is converted to T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-2.6) signifies a reduction in task performance from pre to post-DBS while a positive T-score difference(0.7) denotes an increase in task performance. The larger the absolute T-score value,the greater the mean change in performance.|Pre-surgery baseline to 6 months of DBS stimulation|||T-score||Standard Deviation|Mean
153077|NCT00360009|Secondary|Change in Beck Depression Inventory (BDI)|BDI is a questionnaire used to measure depression. There is a four-point scale for each of the 21-items of the questionnaire with scores ranging from 0 to 3. Total raw scores range from 0 to 63. The higher the score the greater the severity of depression. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-3.7) indicates a reduction in depression from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in depression. The larger the absolute T-score value,the greater the mean change in depression.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.||T-score||Standard Deviation|Mean
153078|NCT00360009|Secondary|Change in Spielberger State-Trait Anxiety Inventory (STAI)|STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-1.4) indicates a reduction in anxiety from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in anxiety. The larger the absolute T-score value,the greater the mean change in anxiety.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.||T-score||Standard Deviation|Mean
153079|NCT00360009|Primary|Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State|VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.|Pre-surgery baseline to 6 months of DBS stimulation|Control Group data not reported for this outcome measure because the purpose of the Control Group was just to test effects of fatigue.||T-score||Standard Deviation|Mean
153120|NCT00359788|Secondary|Evening PEFR at Week 2|Weekly means for evening PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153081|NCT00359983|Secondary|hSBA-MenY Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Titer||95% Confidence Interval|Geometric Mean
153082|NCT00359983|Secondary|Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
153083|NCT00359983|Secondary|hSBA-MenC Geometric Mean Titers (GMTs)|"Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Titer||95% Confidence Interval|Geometric Mean
153084|NCT00359983|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
153085|NCT00359983|Secondary|Anti-PRP Geometric Mean Concentrations (GMCs)|"Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL).~Results up to 5 years after the fourth dose are presented."|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||µg/mL||95% Confidence Interval|Geometric Mean
153086|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
153087|NCT00359983|Primary|Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
153088|NCT00359983|Primary|Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter|Results up to 5 years after the fourth dose are presented.|One year, three years, and five years after the fourth dose vaccination.|Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.||Subjects|||Number
153089|NCT00359944|Secondary|Disability Assessment for Dementia (DAD)|"Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.~The DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction."|Baseline to 16 Weeks|||units on a scale||Standard Deviation|Mean
153090|NCT00359944|Secondary|Clinicians Interview Based Impression of Change (CIBIC)-Plus|"Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.~CIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end."|Baseline to 16 weeks|||units on a scale||Standard Deviation|Mean
153091|NCT00359944|Primary|Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)|Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.|Baseline to 16 weeks|||units on a scale||Standard Deviation|Mean
153092|NCT00359801|Primary|Time to Persistent Decline in FEV1 Exceeding 20% From Baseline|Elapsed time, in days, from the start of subject’s participation in the study to the first reading of FEV1 that is: 20% or more below the subject’s latest pre-study measurement, subsequently confirmed as a >20% decline [(baseline observed value minus visit observed value)/by baseline observed value *100], and assessed as persistent as defined by protocol process. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to latest valid FEV1 measurement for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
153093|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c taken as the latest determination prior to beginning study participation. Change = on-study value (for measurements falling within the time window associated with a given analysis set) minus the baseline value. Linear model with terms for treatment, baseline HbA1c, time on study, and subject within treatment.|Baseline to 5 years|FAS. Due to early study termination, the originally planned inferential analysis (linear model) for change from baseline was not done.||percent|||Number
153094|NCT00359801|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline|Baseline HbA1c: the latest determination prior to beginning study participation. Change from Baseline: HbA1c at observation (falling within the time window associated with a given analysis set) minus the baseline value.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.||percent||Standard Deviation|Mean
153095|NCT00359801|Secondary|Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for allergic response. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
153096|NCT00359801|Secondary|Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite or possible: anaphylaxis, angioedema/urticaria, bronchospasm or possible allergic reaction not otherwise specified (NOS); Insufficient: insufficient data.|Baseline through End of Study|FAS||events|||Number
153097|NCT00359801|Secondary|Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for cardiovascular SAE composite. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
153098|NCT00359801|Secondary|Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|Endpoint committee adjudicated based on review of medical/hospital records; results classified using standard criteria. Definite: definite MI or stroke; Possible: possible MI or stroke; Other (non-MI, non-stroke): other cardiovascular event (non-MI, non-stroke); Definite or possible: either definite or possible or both; Insufficient: insufficient data; Death from cardiovascular or cerebrovascular: cardiovascular or cerebrovascular event; Definite or possible or death from cardiovascular or cerebrovascular: either definite or possible or both or cardiovascular or cerebrovascular event.|Baseline through End of Study|FAS||events|||Number
153099|NCT00359801|Primary|Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects|Confirmed FEV1 decline: any two consecutive declines that are >= 14 days apart. The pulmonary function test that established persistence occured >= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|FAS||participants|||Number
153100|NCT00359801|Secondary|Time to Event: All-cause Mortality|Time to all-cause mortality: elapsed time, in days, from the start of a subject’s participation in the study to the date of the event subsequently confirmed (according to protocol definition) as meeting the criteria for all-cause mortality. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
153101|NCT00359801|Secondary|All-cause Mortality: Number of Deaths|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria (confirmation of deaths by blinded adjudicator(s) through medical records or death certificates). Patients meeting the endpoint All Cause Mortality after adjudication by the endpoint committee.|Baseline through End of Study|FAS||participants|||Number
153102|NCT00359801|Secondary|Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Elapsed time, in days, from the start of a subject’s participation in the study to the date of the first report of an event subsequently confirmed (according to protocol definition) as meeting the criteria for pulmonary SAE composite. Censoring time: elapsed time, in days, from the start of a subject’s participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.|Baseline to 5 years|FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.||days|||Number
153103|NCT00359801|Secondary|Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis|Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite: definite pneumonia, definite COPD, or definite asthma; possible: possible pneumonia, possible COPD, possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis; definite or possible: either definite or possible; insufficient: insufficient data.|Baseline through End of Study|FAS||events|||Number
153104|NCT00359801|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value. Index Visit: date subject had final scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Week 26, Week 52, Week 104, Index Visit|FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.||liters||Standard Deviation|Mean
153105|NCT00359801|Primary|Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline|Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.|Baseline, Month 6, Year 1, Year 2, Index Visit|Full Analysis Set: all randomized subjects.||participants|||Number
153106|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
153107|NCT00359788|Secondary|Physician Global Evaluation|The Physician Global Evaluation reflected the physician's opinion of the patients overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
153108|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to COPD. The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8).|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
153109|NCT00359788|Secondary|Patient Global Evaluation|The Patient Global Evaluation reflected the patient's opinion of their overall condition with respect to chronic obstructive pulmonary disease (COPD). The scale responses were: Poor (1,2). Fair (3,4), Good (5,6) and Excellent (7,8)|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Units on a scale||Standard Error|Least Squares Mean
153110|NCT00359788|Secondary|Evening PEFR at Week 12|Weekly means for evening PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153111|NCT00359788|Secondary|Evening PEFR at Week 11|Weekly means for evening PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153112|NCT00359788|Secondary|Evening PEFR at Week 10|Weekly means for evening PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153113|NCT00359788|Secondary|Evening PEFR at Week 9|Weekly means for evening PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153114|NCT00359788|Secondary|Evening PEFR at Week 8|Weekly means for evening PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153115|NCT00359788|Secondary|Evening PEFR at Week 7|Weekly means for evening PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153116|NCT00359788|Secondary|Evening PEFR at Week 6|Weekly means for evening PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153117|NCT00359788|Secondary|Evening PEFR at Week 5|Weekly means for evening PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153118|NCT00359788|Secondary|Evening PEFR at Week 4|Weekly means for evening PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153119|NCT00359788|Secondary|Evening PEFR at Week 3|Weekly means for evening PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153121|NCT00359788|Secondary|Evening PEFR at Week 1|Weekly means for evening PEFR|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153122|NCT00359788|Secondary|Morning PEFR at Week 12|Weekly means for morning PEFR|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153123|NCT00359788|Secondary|Morning PEFR at Week 11|Weekly means for morning PEFR|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153124|NCT00359788|Secondary|Morning PEFR at Week 10|Weekly means for morning PEFR|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153125|NCT00359788|Secondary|Morning PEFR at Week 9|Weekly means for morning PEFR|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153126|NCT00359788|Secondary|Morning PEFR at Week 8|Weekly means for morning PEFR|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153127|NCT00359788|Secondary|Morning PEFR at Week 7|Weekly means for morning PEFR|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153128|NCT00359788|Secondary|Morning PEFR at Week 6|Weekly means for morning PEFR|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153129|NCT00359788|Secondary|Morning PEFR at Week 5|Weekly means for morning PEFR|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153130|NCT00359788|Secondary|Morning PEFR at Week 4|Weekly means for morning PEFR|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153131|NCT00359788|Secondary|Morning PEFR at Week 3|Weekly means for morning PEFR|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153132|NCT00359788|Secondary|Morning PEFR at Week 2|Weekly means for morning PEFR|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153133|NCT00359788|Secondary|Morning Peak Expiratory Flow Rate (PEFR) at Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters/minute||Standard Error|Least Squares Mean
153134|NCT00359788|Secondary|Night Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the night in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153135|NCT00359788|Secondary|Night Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the night in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153136|NCT00359788|Secondary|Night Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the night in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153137|NCT00359788|Secondary|Night Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the night in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153138|NCT00359788|Secondary|Night Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the night in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153139|NCT00359788|Secondary|Night Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the night in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153140|NCT00359788|Secondary|Night Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the night in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153141|NCT00359788|Secondary|Night Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the night in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153142|NCT00359788|Secondary|Night Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the night in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153143|NCT00359788|Secondary|Night Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the night in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153144|NCT00359788|Secondary|Night Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the night in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153145|NCT00359788|Secondary|Night Time Albuterol Use During Week 1||Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per night||Standard Error|Least Squares Mean
153146|NCT00359788|Secondary|Day Time Albuterol Use During Week 12|Puffs of rescue albuterol used during the day in week 12|Week 12|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153147|NCT00359788|Secondary|Day Time Albuterol Use During Week 11|Puffs of rescue albuterol used during the day in week 11|Week 11|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153148|NCT00359788|Secondary|Day Time Albuterol Use During Week 10|Puffs of rescue albuterol used during the day in week 10|Week 10|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153149|NCT00359788|Secondary|Day Time Albuterol Use During Week 9|Puffs of rescue albuterol used during the day in week 9|Week 9|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153150|NCT00359788|Secondary|Day Time Albuterol Use During Week 8|Puffs of rescue albuterol used during the day in week 8|Week 8|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153151|NCT00359788|Secondary|Day Time Albuterol Use During Week 7|Puffs of rescue albuterol used during the day in week 7|Week 7|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153152|NCT00359788|Secondary|Day Time Albuterol Use During Week 6|Puffs of rescue albuterol used during the day in week 6|Week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153153|NCT00359788|Secondary|Day Time Albuterol Use During Week 5|Puffs of rescue albuterol used during the day in week 5|Week 5|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153154|NCT00359788|Secondary|Day Time Albuterol Use During Week 4|Puffs of rescue albuterol used during the day in week 4|Week 4|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153155|NCT00359788|Secondary|Day Time Albuterol Use During Week 3|Puffs of rescue albuterol used during the day in week 3|Week 3|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153156|NCT00359788|Secondary|Day Time Albuterol Use During Week 2|Puffs of rescue albuterol used during the day in week 2|Week 2|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153157|NCT00359788|Secondary|Day Time Albuterol Use During Week 1|Puffs of rescue albuterol used during the day in week 1|Week 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Puffs per day||Standard Error|Least Squares Mean
153158|NCT00359788|Secondary|FVC at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153159|NCT00359788|Secondary|FVC at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153160|NCT00359788|Secondary|FVC at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153161|NCT00359788|Secondary|FVC at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153162|NCT00359788|Secondary|FVC at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153165|NCT00359788|Secondary|FVC at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153166|NCT00359788|Secondary|FVC at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153167|NCT00359788|Secondary|FVC at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153168|NCT00359788|Secondary|FVC at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153169|NCT00359788|Secondary|FVC at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153170|NCT00359788|Secondary|FVC at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153171|NCT00359788|Secondary|FVC at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153172|NCT00359788|Secondary|FVC at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153173|NCT00359788|Secondary|FVC at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153174|NCT00359788|Secondary|FVC at 6 Hours on Day 1||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153175|NCT00359788|Secondary|FVC at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153176|NCT00359788|Secondary|FVC at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153177|NCT00359788|Secondary|FVC at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153178|NCT00359788|Secondary|FVC at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153179|NCT00359788|Secondary|FVC at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153180|NCT00359788|Secondary|FVC at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153181|NCT00359788|Secondary|FEV1 at 6 Hours at Week 12||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153182|NCT00359788|Secondary|FEV1 at 4 Hours at Week 12||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153183|NCT00359788|Secondary|FEV1 at 3 Hours at Week 12||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153184|NCT00359788|Secondary|FEV1 at 2 Hours at Week 12||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153185|NCT00359788|Secondary|FEV1 at 1 Hour at Week 12||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153186|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 12||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153187|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 12||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153188|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 12||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153189|NCT00359788|Secondary|FEV1 at 6 Hours at Week 6||6 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153190|NCT00359788|Secondary|FEV1 at 4 Hours at Week 6||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153191|NCT00359788|Secondary|FEV1 at 3 Hours at Week 6||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153192|NCT00359788|Secondary|FEV1 at 2 Hours at Week 6||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153193|NCT00359788|Secondary|FEV1 at 1 Hour at Week 6||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153194|NCT00359788|Secondary|FEV1 at 30 Minutes at Week 6||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153195|NCT00359788|Secondary|FEV1 at 15 Minutes at Week 6||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153196|NCT00359788|Secondary|FEV1 at -10 Minutes at Week 6||10 minutes before dosing|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153197|NCT00359788|Secondary|FEV1 at 6 Hours on Day 1||6 hours|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153198|NCT00359788|Secondary|FEV1 at 4 Hours on Day 1||4 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153199|NCT00359788|Secondary|FEV1 at 3 Hours on Day 1||3 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153200|NCT00359788|Secondary|FEV1 at 2 Hours on Day 1||2 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Least Squares Mean||Standard Error|Least Squares Mean
153201|NCT00359788|Secondary|FEV1 at 1 Hour on Day 1||1 hour|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153202|NCT00359788|Secondary|FEV1 at 30 Minutes on Day 1||30 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153203|NCT00359788|Secondary|FEV1 at 15 Minutes on Day 1||15 minutes|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153204|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 12|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153205|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) at Week 6|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|baseline and 6 Weeks (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153206|NCT00359788|Secondary|Change From Baseline in Peak FVC (Forced Vital Capacity) on Day 1|Peak FVC is defined as the maximum FVC observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153207|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 6 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153208|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FVC AUC0-6 minus baseline FVC|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153209|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 6 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153210|NCT00359788|Secondary|Change From Baseline in Average Hourly FVC AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FVC AUC0-6 minus baseline FVC|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153211|NCT00359788|Secondary|Change From Baseline in Trough FVC (Forced Vital Capacity) at 12 Weeks|Trough FVC is measured 10 minutes before drug administration|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153212|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 12|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 12 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153213|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) at Week 6|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Baseline and 6 weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153214|NCT00359788|Secondary|Change From Baseline in Peak FEV1 (Forced Expiratory Volume in 1 Second) on Day 1|Peak FEV1 is defined as the maximum FEV1 observed in the first three hours after dose of study medication|Day 1|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153215|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at Week 6|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and week 6|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153216|NCT00359788|Secondary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) on Day 1|Average hourly FEV1 AUC0-6 minus baseline FEV1|Day 1 (after first dose)|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153217|NCT00359788|Secondary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 6 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 6 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153218|NCT00359788|Primary|Change From Baseline in Average Hourly FEV1 AUC0-6 (Area Under the Curve From Zero to Six Hours) at 12 Weeks|Average hourly FEV1 AUC0-6 minus baseline FEV1|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153219|NCT00359788|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second) at 12 Weeks|Trough FEV1 is measured 10 minutes before drug administration|Baseline and 12 Weeks|Participants analyzed belonged to the Full Analysis Set (FAS) and included all patients randomized, treated with study medication and had baseline FEV1 and at least one post-dose trough FEV1.||Liters||Standard Error|Least Squares Mean
153220|NCT00359762|Secondary|Hypoglycemia Rate Per Year in Period III|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Start of Period III to end of study|Extension ITT Safety Population: Extension enrolled patients receiving at least one dose of study medication in Study Period III.||events per subject-year||Standard Deviation|Mean
153221|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy population. The analysis included patients not randomized at entry in study period III. Missing data at Year 2 was not imputed.||percentage of total hemoglobin||Standard Deviation|Mean
153222|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III|Change in HbA1c from baseline to Year 2.|Baseline in Period III, Year 2 in Period III|Extension ITT Efficacy Population: Extension enrolled patients with at least one post-baseline measurement of HbA1c in Study Period III. The analysis included patients randomized at entry in study period III. Missing data at Year 2 was not imputed.||percentage of total hemoglobin||Standard Error|Least Squares Mean
153223|NCT00359762|Secondary|Hypoglycemia Rate Per Year|All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination.|Baseline to end of Period II (up to 4.5 years)|ITT Safety Population.||events per subject-year||Standard Error|Least Squares Mean
153224|NCT00359762|Secondary|High-density Lipoprotein (HDL) Cholesterol at Year 3|HDL Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
154256|NCT00350207|Secondary|Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3|Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
153225|NCT00359762|Secondary|Total Cholesterol at Year 3|Total Cholesterol at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
153226|NCT00359762|Secondary|Triglycerides at Year 3|Triglycerides at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
153227|NCT00359762|Secondary|Heart Rate at Year 3|Heart rate at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||beats per minute||Standard Error|Least Squares Mean
153228|NCT00359762|Secondary|Diastolic Blood Pressure at Year 3|Diastolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmHg||Standard Error|Least Squares Mean
153229|NCT00359762|Secondary|Systolic Blood Pressure at Year 3|Systolic Blood pressure at Year 3.|Year 3 in Period II|ITT Safety Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmHg||Standard Error|Least Squares Mean
153230|NCT00359762|Secondary|Change in Body Weight From Baseline to Year 3|Change in Body weight from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Safety Population: Enrolled patients receiving at least one dose of study medication in Study Period II with patients analyzed according to treatment actually received. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||kg||Standard Error|Least Squares Mean
153231|NCT00359762|Secondary|Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint|Change from baseline in postprandial (2 hours) plasma glucose to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||mmol/L||Standard Error|Least Squares Mean
153232|NCT00359762|Secondary|Postprandial (2 Hours) Plasma Glucose at Year 3|Postprandial (2 hours) plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
153233|NCT00359762|Secondary|Change in Fasting Plasma Glucose From Baseline to Endpoint|Change in fasting plasma glucose from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||mmol/L||Standard Error|Least Squares Mean
153234|NCT00359762|Secondary|Fasting Plasma Glucose at Year 3|Fasting plasma glucose at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||mmol/L||Standard Error|Least Squares Mean
153235|NCT00359762|Secondary|Change in HbA1c From Baseline to Endpoint|Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study).|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population.||percentage of total hemoglobin||Standard Error|Least Squares Mean
153236|NCT00359762|Secondary|Change in HbA1c From Baseline to Year 3|Change in HbA1c from baseline to Year 3.|Baseline, Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||percentage of total hemoglobin||Standard Error|Least Squares Mean
153237|NCT00359762|Secondary|Change in Disposition Index From Baseline to Endpoint|Change in disposition index from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
153238|NCT00359762|Secondary|Disposition Index at Year 3|Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
153239|NCT00359762|Secondary|Change in DI30/DG30 Ratio From Baseline to Endpoint|Change in DI30/DG30 ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
153240|NCT00359762|Secondary|Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3|DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
153241|NCT00359762|Secondary|Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.|Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using LOCF approach.||ratio||Standard Error|Least Squares Mean
153242|NCT00359762|Secondary|Fasting Proinsulin/Insulin Ratio at Year 3|Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3.|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
153243|NCT00359762|Secondary|Change in HOMA-B From Baseline to Endpoint|Change in HOMA-B from baseline to endpoint.|Baseline, end of Period II (up to 4.5 years)|ITT Efficacy Population. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.||ratio||Standard Error|Least Squares Mean
153244|NCT00359762|Secondary|Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3|HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175).|Year 3 in Period II|ITT Efficacy Population. The analysis included only time points up to that week where at least 25% of the originally enrolled population was still in the study. Missing data at Year 3 was not imputed.||ratio||Standard Error|Least Squares Mean
153245|NCT00359762|Primary|Time to Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population.||week||95% Confidence Interval|Median
153246|NCT00359762|Primary|Number of Patients With Treatment Failure|Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents.|Baseline to end of Period II (up to 4.5 years)|ITT Efficacy Population: Enrolled patients with a baseline and at least one post-baseline measurement of HbA1c in Study Period II (including only Study Period II); patients analyzed according to treatment as randomized.||number of patients|||Number
153247|NCT00359736|Primary|Change in 6-minute Walk Test|Distance in meters -- Distance (meters) walked in 6 minutes|0 - 6 months|||meters||Standard Deviation|Mean
153248|NCT00359736|Secondary|Dyspnea Score (Borg Scale)|"The Dyspnea score or Borg Rating of Perceived Exertion (RPE) Scale score is a subjective rating of perceived exertion. In medicine this is used to document the patient's effort and exertion, breathlessness and fatigue during a physical test.~The Dyspnea score ranges from 0 (No breathlessness at all) to 10 (Maximum or extremely strong breathlessness).~IN this study the Specific Objective 2 was to assess and compare changes from baseline in pre- and post-exercise dyspnea in the sildenafil and placebo control groups."|0 - 6 months|||units on a scale||Standard Deviation|Mean
153249|NCT00359632|Secondary|Percentage of Participants by Clinical Outcome of Infection at End of Study|Clinical response was evaluated at the End of Study visit (30 days after last dose) as Cure, Improvement, Failure, Unknown or Other. Clinical response was based primarily on the global assessment of the clinical presentation of the subject made by the investigator at that evaluation timepoint. The clinical response classifications were defined as follows. Cure: Resolution of the clinical signs and symptoms of infection, when compared to Baseline. No additional antimicrobial treatment is required for the disease under study. Improvement: Improvement in 2 or more, but not all, of the clinical signs and symptoms of infection, when compared with Baseline. No additional antimicrobial treatment is required for the disease under study. Failure: Persistence or progression of Baseline clinical signs and symptoms of infection, or development of new clinical findings consistent with active infection. Unknown: Inability to assess clinical response.|At End of Study visit|||Percentage of Participants|||Number
153250|NCT00359632|Primary|Percentage of Participants With an Adverse Event||Through and including 28 calendar days after the last administration of the investigational product|||Percentage of Participants|||Number
153251|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.|From Month 0 to Month 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
153252|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.|From Month 0 to Month 36|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
153253|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.|From Month 0 to Month 24|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
153254|NCT00359619|Secondary|Number of Subjects With Pregnancy Outcomes.|Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
153255|NCT00359619|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
153256|NCT00359619|Secondary|Number of Subjects With at Least One Medically Significant Condition (MAEs).|MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
154837|NCT00338039|Primary|Overall Survival Rate|1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.|1 to 4 years|||percentage of participants|||Number
153257|NCT00359619|Secondary|Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)|From Month 0 to Months 18, 24, 36 and 48|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.||subjects|||Number
153258|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
153259|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
153260|NCT00359619|Secondary|Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL.||95% Confidence Interval|Geometric Mean
153261|NCT00359619|Secondary|Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
153262|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
153263|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
153264|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
153265|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||Titers||95% Confidence Interval|Geometric Mean
153266|NCT00359619|Primary|Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.|Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||EL.U/mL||95% Confidence Interval|Geometric Mean
153267|NCT00359619|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).|At Months 18, 24, 36 and 48.|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
153276|NCT00359424|Secondary|Asymptomatic Intracranial Hemorrhage|Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site.|within 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.||participants|||Number
153268|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|360 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <330 days or >390 days post-randomization are assigned an unfavorable outcome (mRS>2).||participants|||Number
153269|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|270 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <240 days or >300 days post-randomization are assigned an unfavorable outcome (mRS>2).||participants|||Number
153270|NCT00359424|Secondary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 180 days|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <150 days or >210 days post-randomization are assigned an unfavorable outcome (mRS>2).||participants|||Number
153271|NCT00359424|Secondary|Trail Making Test Part B Time|The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a “trail” made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.|at 90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part B.||seconds||Standard Deviation|Mean
153272|NCT00359424|Secondary|Trail Making Test Part A Time|The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a “trail” made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.|90 days post randomization|Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part A.||seconds||Standard Deviation|Mean
153273|NCT00359424|Secondary|Barthel Index (BI) Dichotomized 0-90 Versus 95-100|The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing BI and BI measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (BI 0-90).||participants|||Number
153274|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.|The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit.|at 90 days post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (NIHSS score>1).||participants|||Number
153275|NCT00359424|Secondary|National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.|"The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher~>> scores indicating greater severity of deficit."|at 24 hours post randomization|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <18 hours or >30 hours post-randomization are assigned an unfavorable outcome (NIHSS score>1).||participants|||Number
153277|NCT00359424|Secondary|Incidence of Parenchymal Type II (PH2) Hematomas|a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans.|within 30 hours post IV rt-PA|Subjects were excluded if a post-baseline CT scan was not obtained within 30 hours of randomization (i.e., participants who died, had care withdrawn at the request of the family, or underwent imaging after the 30-hour window).||participants|||Number
153278|NCT00359424|Primary|Symptomatic Intracranial Hemorrhage|Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site|within the first 30 hours post IV rt-PA|The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.||participants|||Number
153279|NCT00359424|Primary|Death Due to Any Cause||within 90 days post randomization|The intent-to-treat analysis includes all subjects who were randomized, and each subject analyzed according to the treatment group to which they were randomly assigned. Subjects who ended the study prior to 90 days post- randomization for a reason other than death (LTFU etc) (n=8 in group two; n=2 in group one) are assumed to be alive||participants|||Number
153280|NCT00359424|Primary|Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.|The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent.|at 90 days post randomization|The primary analysis was conducted according to intention to treat. All subjects were analyzed in the treatment group to which they were randomized. Subjects with missing mRS (n=9 in group two; n=4 in group one) or mRS assessed <60 days or >120 days post-randomization (n=10 in group two; n=4 in group one) are assigned an unfavorable outcome(mRS >2)||participants|||Number
153281|NCT00359281|Primary|AUC0-t Nicotinuric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153282|NCT00359281|Primary|AUC0-t Nicotinic Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153283|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153284|NCT00359281|Primary|AUC0-t Atorvastatin Acid (Lomitapide 60 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153285|NCT00359281|Primary|AUC0-t Fenofibric Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153286|NCT00359281|Primary|AUC0-t Rosuvastatin (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153287|NCT00359281|Primary|AUC0-t Total Ezetimibe|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153288|NCT00359281|Primary|AUC0-t Simvastatin Acid|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153289|NCT00359281|Primary|AUC0-t Simvastatin|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin|0 to 24 hours|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153290|NCT00359281|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline to Day 8|Intention To Treat||Percent Change||Standard Deviation|Mean
153291|NCT00359281|Primary|Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)|Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)|0 to 24 hour|Pharmacokinetic||Ratio||90% Confidence Interval|Geometric Mean
153292|NCT00359216|Primary|Apnea-Hypopnea Index|Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.|change from baseline (screening) at the end of 28 days of treatment|Diary data over interval of days was derived using the mean of non-missing entries. No imputation was applied to any other missing data||apnea-hypopnea episodes per hour||Standard Deviation|Mean
153293|NCT00359203|Primary|Syncope Recurrence Rate|Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement|2 years|77 patients implanted with dual chamber pacemaker: 39 patients randomized to pacemaker OFF and 38 patients randomized to pacemaker ON||percentage of participants||95% Confidence Interval|Number
153294|NCT00359138|Primary|Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment|The number of days after treatment discontinuation until a measurable wheal and flare response.|Starting at Day 8|||Days||Standard Error|Mean
153295|NCT00359021|Secondary|Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)|In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).|Baseline, Week 24, Week 48, and Week 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.||log10 copies/mL||95% Confidence Interval|Mean
153296|NCT00359021|Secondary|The Percentage of Participants With Virologic Outcomes Over Time|The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).|Weeks 24, 48, and 96|The intent-to-treat (ITT) population was used as the primary analysis population for the efficacy analysis and included all participants who took at least one dose of etravirine (ETR) (also known as TMC125) in the TMC125-C217 study.||Percentage of Participants|||Number
153297|NCT00359021|Primary|The Number of Participants Experiencing Adverse Events|The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.|1 week to 180 weeks, with a median of 62 weeks|The safety analysis was carried out on the ITT population, which included all participants who received at least one dose of investigational medication.||Participants|||Number
153298|NCT00358956|Secondary|Biochemical Response Carcinoembryonic Antigen CEA)|A patient’s best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for Partial Response (PR) or Complete Response (CR) were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation|||Participants|||Number
153299|NCT00358956|Secondary|Biochemical Response Calcitonin (CTN )|A patient’s best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met.|Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters)|||Participants|||Number
153300|NCT00358956|Secondary|Symptomatic Response|Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level.|Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment.|||Participants|||Number
153301|NCT00358956|Secondary|World Heath Organization (WHO) Performance Status|Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy – 5 dead) based on their physical capabilities|WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment.|||Participants|||Number
153302|NCT00358956|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 24 weeks|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.|||Participants|||Number
153303|NCT00358956|Secondary|Progression-Free Survival (PFS)|Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.|||Months||95% Confidence Interval|Median
153304|NCT00358956|Primary|Objective Response Rate (ORR)|"The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.~The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE."|RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.|||Participants|||Number
153305|NCT00358917|Secondary|Percentage of Participants With New Primary Protease Mutations at Week 48|Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).|Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and had post baseline genotypic resistance assay results.||Percentage of Participants|||Number
153306|NCT00358917|Secondary|Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir|Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.|Week 48 (End of Study)|Dropouts-as-censored: participants were responders if they had HIV-1 RNA <50 copies/mL at Week 48. Participants who discontinued (d/c'd) while suppressed or w/o post baseline (BL) levels were excluded. Those d/c'd <Day 85 were excluded unless they had >=1 post BL level & didn't achieve a decrease >=1.0 log10 copies/mL, then they were nonresponders.||Percentage of Participants|||Number
153307|NCT00358917|Secondary|Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts||Week 48 (End of Study)|All randomized participants who received at least 1 dose of study drug and who had CD4+ T cell counts at both the Baseline Visit and Week 48.||cells/microliter||Standard Error|Mean
153308|NCT00358917|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48||Week 48 (End of Study)|Observed data analysis using all available Week 48 data from all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
153309|NCT00358917|Primary|Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.|Week 48 (End of Study)|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.||Percentage of Participants|||Number
153310|NCT00358826|Other Pre-specified|Change From Baseline in Percent Stenosis||Baseline and 24 weeks|Evaluable Population||Percentage||95% Confidence Interval|Least Squares Mean
153311|NCT00358826|Other Pre-specified|Change From Baseline in Mean Plaque Density|Plaque density is expressed in Hounsfield Units (HU)|Baseline and 24 weeks|Evaluable Population||HU||95% Confidence Interval|Least Squares Mean
153312|NCT00358826|Other Pre-specified|Change From Baseline in Noncalcified Plaque Volume||Baseline and 24 weeks|Evaluable Population||mm^3||95% Confidence Interval|Least Squares Mean
153313|NCT00358826|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy||Baseline and 24 weeks|Evaluable Population of the MDCT substudy||mg/L||Inter-Quartile Range|Median
153314|NCT00358826|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study||Baseline and 12 weeks|Evaluable Population||mg/L||Inter-Quartile Range|Median
153315|NCT00358826|Secondary|Change From Baseline in Leukotriene E4 (LTE4)|Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate|Baseline and 12 weeks|Core Study Evaluable Population||pg/mg Cr||95% Confidence Interval|Least Squares Mean
153316|NCT00358826|Primary|Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood||Baseline and 12 weeks|Core Study Evaluable Population||pg/mL||95% Confidence Interval|Least Squares Mean
153317|NCT00358735|Secondary|In-Patients’ Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.~The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of treatment at hospital (for the entire arm/group).~The compliance is expressed as percentages."|Surgery till discharge|||percentage of usage time|||Number
153318|NCT00358735|Secondary|Serious Adverse Events|"Serious Adverse Events (SAE) is any event that prolongs hospitalization or requires re-hospitalization, that requires intervention to prevent permanent impairment or damage, that causes permanent disability, or that is life threatening.~SAE did not include Venous thrombolembolism (VTE) events (DVT and PE) and Major bleeding complications as these are outcome measures"|SAE data were collected Up to 3 months post-op|||events|||Number
153319|NCT00358735|Post-Hoc|Composite Outcome of Major Bleeding + VTE|Major bleeding + DVT events + PE Events|Day of surgery and up to 3 months|||Events|||Number
153320|NCT00358735|Post-Hoc|Changes in Hemoglobin Levels|Changes in Hemoglobin levels|After surgery untill discharge|||mean change (g/l)||Standard Deviation|Mean
153321|NCT00358735|Post-Hoc|Bleeding Index ≥ 2|Bleeding index was defined as the number of units of whole blood or packed red blood cells transfused plus the difference between the first hemoglobin value after surgery and the value prior to discharge|Surgery till discharge|||units on a scale||Standard Deviation|Mean
153322|NCT00358735|Post-Hoc|Autologous Blood Transfusion Units|Autologous blood transfusion per patient in specific treatment Group|Up to 30 days|||Avg. Unit per patient in arm||Standard Deviation|Mean
153323|NCT00358735|Post-Hoc|Allogeneic Blood Transfusion Units|Allogeneic blood transfusion per patient in specific treatment Group|Up to 30 days|||Avg. Unit per patient in arm||Standard Deviation|Mean
153324|NCT00358735|Post-Hoc|Total Number of Blood Transfusion Units|Number of blood units used (Autologous units and allogeneic units) (blood units during surgery not included)|Between the immediate postoperative measurement and discharge|||Units|Participants||Number
153325|NCT00358735|Post-Hoc|Events of Clinical Sign and Symptoms of VTE (DVT and/or PE)|Events of clinical Sign and symptoms of VTE (DVT and/or PE), confirmed by standard objective diagnostic methods|Day of surgery and up to 3 months|||Events|Participants||Number
153326|NCT00358735|Secondary|OutPatient Patients’ Compliance|"Total usage time with the pneumatic device (patient's compliance) was recorded using the ActiveCare+SFT device internal timer.~The compliance was calculate as total actual operation time (for the entire arm/group) divided by the total time passes since the initiation of home treatment (for the entire arm/group).~The compliance is expressed as percentages."|10-12 days post-op|||percentage of usage time|||Number
153327|NCT00358735|Secondary|Major Bleeding Complication|Major bleeding is defined as bleeding that requires rehospitalization or prolonged hospitalization, requires any intervention such as surgery or hematoma aspiration to prevent permanent impairment or damage, endangered critical organs, is life threatening or causes death. Data collected included bleeding index, a decrease in hemoglobin greater than/equal to 20 g/L, and number of units of blood transfused.|Up to 30 days|||Events|Participants||Number
153328|NCT00358735|Primary|Clinical PE (Pulmonary Embolism) Events|Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT|Day of surgery and up to 3 months|||Events|Participants||Number
153329|NCT00358735|Primary|Events of Deep Vein Thrombosis (DVT)|"10-12 days post-op: All of the patients underwent Routine bilateral compression Doppler.~Day of surgery and up to 3 months post-op: Suspected clinical signs and symptoms DVT events were confirmed by standard diagnostic objective methods"|10-12 days post-op; and from day of surgery and up to 3 months if symptomatic|||Events|Participants||Number
153330|NCT00358670|Secondary|PASI 12-month AUC (Time Adjusted Total PASI Score Over the 12 Month Period)|The PASI 12-month AUC is a time adjusted total PASI score over the 12 month (360 days) period. The AUC is a continuous measurement (not a score on a scale); and a lower value is considered better. The weighted average PASI score over 12 months (using all available PASI scores during a 12 month period [from Day 0 to 360 days]) is is obtained by using PASI 12-month AUC /360 days.|Day 0 to 360 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 330 days or more from Study P04563 randomization).||12-month PASI AUC||Standard Error|Mean
153346|NCT00358501|Primary|Complete Response by Day+100 Post Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat||percentage of participants||95.1% Confidence Interval|Number
153331|NCT00358670|Secondary|PASI 6-month Area Under the Curve (AUC); (Time Adjusted Total PASI Score Over the 6 Month Period)|The PASI 6-month AUC is a time adjusted total PASI score over the 6 month (180 days) period. The AUC is a continuous measurement (not a score on a scale); a lower value is considered better and a higher value is considered worse. The weighted average PASI score over 6 months (using all available PASI scores during a 6 month period [from Day 0 to 180 days]) is obtained by using PASI 6-month AUC /180 days.|Day 0 to 180 days|Participants with at least two post Study P04563 randomization PASI scores (at least one is 150 days or more from Study P04563 randomization).||6-month PASI AUC||Standard Error|Mean
153332|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 100|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|100 Weeks|Descriptive summary of all randomized subjects who completed 100 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 100.||Participants|||Number
153333|NCT00358670|Secondary|Number of Participants Who Achieved PASI75 Response at Week 52|PASI75 defined as the number of participants who achieved a >=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)|52 weeks|Descriptive summary of all randomized subjects who completed 52 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 52.||Participants|||Number
153334|NCT00358670|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI75) Response at Week 128|PASI75 defined as the number of participants who achieved a >=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).|128 weeks|Due to the early termination of the study, no subjects completed 128 weeks of therapy.|||||
153335|NCT00358644|Primary|Complete Response = Morphologic Complete Remission (mCR)||1 year|Intent-to-Treat (ITT)||Participants|||Number
153336|NCT00358579|Secondary|Survival to Admission.|Survival to admission is defined as the presence of pulse on admission to hospital (discharged from Emergency Department and admitted to Intensive Care Units /wards). This measures the number of participants with pulse and who were admitted to hospital.|No specific time frame. Survival to admission refers to sustained return of spontaneous circulation until admission and transfer of care to Intensive Care Units /wards|||Participants|||Number
153337|NCT00358579|Secondary|Return of Spontaneous Circulation.|Return of spontaneous circulation is defined as the presence of any palpable pulse detected by manual palpation of a major artery. This is measured as number of participants who had return of spontaneous circulation during resuscitation.|during resuscitation|||Participants|||Number
153338|NCT00358579|Secondary|Neurological Status at 1 Year.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC): 1 and 2. CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 1 year post arrest|||Participants|||Number
153339|NCT00358579|Secondary|Neurological Status on Discharge or at 30 Days Post Arrest, if Not Discharged.|Neurological status is assessed by the Glasgow-Pittsburgh outcome categories, to evaluate quality of life after successful resuscitation. Good neurological status is defined as cerebral performance categories(CPC)/overall performance categories(OPC):1 and 2.CPC/OPC 1 indicates good cerebral & overall performance. CPC/OPC 2 indicates moderate cerebral & overall disability. CPC/OPC 3 indicates severe cerebral & overall disability. CPC/OPC 4 indicates coma, vegetative state. CPC/OPC 5 indicates brain dead/death.|at 30 days post arrest|||Participants|||Number
153340|NCT00358579|Primary|Survival to Hospital Discharge.|Survival to hospital discharge is defined as the patient leaving the hospital alive or survival to 30 days post cardiac arrest,whichever came first. This therefore measures the number of participants who was discharged alive or survived to 30 days post cardiac arrest, whichever came first.|at 30 days post arrest|||Participants|||Number
153341|NCT00358527|Primary|Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.|"Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time.~NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|29 days|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.||Units on a scale||Standard Error|Least Squares Mean
153342|NCT00358527|Primary|Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.|"The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12.~NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate."|Average of the last 7 days of treatment|Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.||Units on a scale||Standard Error|Least Squares Mean
153343|NCT00358501|Other Pre-specified|Historical Control Group Adverse Event Information|Historical Control group was not assessed for severity|Through 30 days from the last dose of Defibrotide|||Number of patients|||Number
153344|NCT00358501|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events||Through 30 days from the last dose of Defibrotide|Safety population||percentage of participants|||Number
153345|NCT00358501|Secondary|Survival at Day+180 Post Hematopoietic Stem Cell Transplantation|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|180 days post hematopoietic stem cell transplant|Intent-to-Treat||percentage of participants||95.1% Confidence Interval|Number
153347|NCT00358501|Primary|Survival at Day+100 Following Hematopoietic Stem Cell Transplant|The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.|Day+100 post hematopoietic stem cell transplant|Intent-to-Treat||percentage of participants||95.1% Confidence Interval|Number
153348|NCT00358462|Primary|mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit|Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit|3 weeks (allowable window 2-5)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for U. urealyticum at baseline||participants|||Number
153349|NCT00358462|Secondary|Clinical Cure as Measured by the Absence of Recurrent or Persistent Signs and/or Symptoms of Urethral Infection Among Case Subjects Who Were Positive for M. Genitalium or Ureaplasmas at the Initial Study Visit||approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)||||||
153350|NCT00358462|Secondary|Minimum Inhibitory Concentrations (MIC) of All Cultivable Strains of M. Genitalium and Ureaplasmas||on-going||||||
153351|NCT00358462|Primary|mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit|Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)|approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)|mITT population (defined as urethral symptoms or visible discharge plus >=5PMNs/HPF at baseline) who tested positive for M. genitalium at baseline||participants|||Number
153352|NCT00358449|Secondary|Plasma Concentration of Mepolizumab|Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 to estimate the plasma concentration of mepolizumab. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.||Microgram per milliliter (µg/mL)||Standard Deviation|Mean
153353|NCT00358449|Secondary|Absolute Blood Eosinophils Count at the Indicated Time Points|Blood samples were obtained at Screening, pre-infusion and 24h and 72-96h post-infusion at Day 1, Weeks 4 and 8; and at Week 2, 6, 10, 12, 16, 20, 24 and 34 visits or Early Withdrawal Visit to estimate blood eosinophil count.|Screening, Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Giga cells per liter (GI/L)||Standard Deviation|Mean
153354|NCT00358449|Secondary|Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an EGD with biopsies at Screening and at Weeks 12 and 24. Mean esophageal eosinophils were calculated as the mean number across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Cells/HPF||Standard Error|Mean
153355|NCT00358449|Secondary|Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24|Participants underwent an esophagogastroduodenoscopy (EGD) with biopsies at Screening and at Weeks 12 and 24. Peak esophageal eosinophils were calculated as the maximum count across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Weeks 12 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Cells/HPF||Standard Error|Mean
153356|NCT00358449|Secondary|Number of Participants With Maintenance of Response|Participants who achieved a response of <5 esophageal eosinophils/HPF at Week 12 by worst case analysis, were evaluated for maintenance of response of <20 cells/HPF at Week 24. Response categories were defined as: non-responder (did not respond at Week 12 or Week 24); delayed responder (did not respond at Week 12 but responded at Week 24); relapsed (responded at Week 12 but not at Week 24); maintained (responded at Week 12 and Week 24). The following assumptions were made for worst case: if a Participant dropped out of the study due to lack of efficacy or an adverse event and had a missing response, their response was imputed as not achieved (i.e. failure). However for Participants withdrawn for other reasons (e.g. lost to follow-up) with a missing response (i.e. did not have the biopsy) the response was made as missing and not imputed.|Week 12 and Week 24|ITT Population. Only those participants were responders at Week 12 were analyzed.||Participants|||Number
153357|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years)|The percentage of days with feeling of something stuck in throat during each analysis period (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
153370|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Stomach|The percentage of days with the symptom of pain in stomach during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
153358|NCT00358449|Secondary|Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only)|Par. and/or parent/guardian recorded daily symptoms of the feeling like something is stuck in throat on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom of feeling of something stuck was not experienced. On days that feeling of something stuck in the throat was experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. Average bothersome score was calculated as the sum of the respective scores for that interval divided by the number of days. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a Scale||95% Confidence Interval|Least Squares Mean
153359|NCT00358449|Secondary|Change From Baseline in the Percentage of Days Participants Ate Solid Foods|The percentage of days with the symptom of difficulty and pain when eating solid foods during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
153360|NCT00358449|Secondary|Change in Baseline in Pain With Eating Solid Foods Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned for that symptom when Par. did not eat. The severity of pain was assessed when Par. eats food as: 1=didn’t hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
153361|NCT00358449|Secondary|Change From Baseline in Difficulty With Eating Solid Foods|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP and FP. A score of 6 was assigned for that symptom when Par. did not eat solid foods. When Par.eat solid foods, the amount of difficulty was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interactions.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
153362|NCT00358449|Secondary|Change From Baseline in Percentage of Days on Which the Participant Drank|The percentage of days with the symptom of difficulty and pain when participant drank during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
153363|NCT00358449|Secondary|Change From Baseline in Pain With Drinking Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned the day participant did not drink. The severity of pain was assessed as: 1=didn’t hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average difficulty and pain severity scores was calculated as the sum of the respective scores for that interval divided by the number of days in the interval. . Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
153811|NCT00354159|Secondary|Freedom From All Cause Death or Heart Failure Hospitalization|Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period|12 months post-implant|All randomized subjects||Number of subjects meeting endpoint|||Number
153364|NCT00358449|Secondary|Change From Baseline in Daily Degree of Difficulty With Drinking|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned days the participant did not drink. The amount of difficulty with drinking was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average difficulty for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the drinking difficulty scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a Scale||95% Confidence Interval|Least Squares Mean
153365|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Vomiting|The percentage of days with the symptom of vomiting during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
153366|NCT00358449|Secondary|Change From Baseline in Frequency of Vomiting|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A participant vomiting any time was counted as one episode of vomiting, irrespective of how close they are to each other. The daily frequency of vomiting was calculated as the total number of times the participant vomited during the interval divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Occurrences of vomiting per day||95% Confidence Interval|Least Squares Mean
153367|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores|The percentage of days with the symptom of pain in regurgitation bothersome during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
153368|NCT00358449|Secondary|Change From Baseline in Regurgitation Bothersome Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom regurgitation was not experienced. The days regurgitation experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for Baseline score, treatment group, age group interactions|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
153369|NCT00358449|Secondary|Change From Baseline in Percentage of Days With Pain in Chest/Throat|The percentage of days with the symptom of pain in chest/throat during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Percentage of days||95% Confidence Interval|Least Squares Mean
153379|NCT00358449|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP measurements were obtained at the following time points: screening, pre-infusion, 10 minutes (m), 30m, 1 hour (h), 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Millimeters of mercury (mmHg)||Standard Deviation|Mean
153371|NCT00358449|Secondary|Change From Baseline in Pain in Chest/Throat Severity Scores|Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in chest/throat was not experienced. If pain in chest/throat was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
153372|NCT00358449|Secondary|Change From Baseline in Pain in Stomach Severity Scores|Par.and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in stomach was not experienced. If pain in stomach was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric Analysis of Covariance (ANCOVA) models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction|Screening, Weeks 9-12 and Weeks 21-24|ITT Population. The observed case (OC) datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Scores on a scale||95% Confidence Interval|Least Squares Mean
153373|NCT00358449|Primary|Plasma Clearance (CL) of Mepolizumab|Clearance is defined as the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate plasma clearance of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population||Liters per Day (L/day)||95% Confidence Interval|Geometric Mean
153374|NCT00358449|Primary|Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Central volume of distribution is a hypothetical volume into which a drug initially distributes upon administration. Peripheral volume of distribution is the sum of all tissue spaces outside the central compartment. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate central (V1) and periperial (V2) and Steady State (Vss) volume of distribution of mepolizumab.|Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34|Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.||Liters||95% Confidence Interval|Geometric Mean
153375|NCT00358449|Primary|Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12|A responder was defined as a participant achieving a reduction in esophageal eosinophils to <5 cells per HPF as the highest count of eosinophils per HPF in all the esophageal sites biopsied at Week 12, confirmed by biopsy at Week 12 or at an early withdrawal visit prior to Week 12. A worst case (WC) approach was considered, if a particiapant withdrew prematurely : If a particiapnt dropped out of the study without having a biopsy taken, due to lack of efficacy or an adverse event, their response was imputed as not achieved. Participants who withdrew, without a biopsy, for other reasons (e.g. lost to follow-up) were considered non-evaluable for the primary analysis. For participants who withdrew early from the study and had a biopsy, the biopsy was used to determine their response.|Week 12|ITT Population-WC||Participants|||Number
153376|NCT00358449|Primary|Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit.|Blood samples for testing anti-mepolizumab antibodies were collected on Day 1, Week 4 and 8 Infusion Visit (before the IV infusion) and at Week 12, 24 and 34 Week follow-up visits. The presence of anti-human mepolizumab antibodies was assessed using an immunoelectrochemiluminescent (ECL) assay. To address transient positive results, an assessment of repeated results were made. For any visit category: results were considered as positive if it was positive at any visit during the study, and results were considered as negative if it were negative at all visits during the study. For repeat visit category: results were considered as postive if the result was positive at >1 visit, and results were considered as negative if the result was negative at all visits or was positive at only one visit.|Day 1, Weeks 4, 8, 12, 24, and 34|ITT Population||Participants|||Number
153377|NCT00358449|Primary|Change From Baseline in Temperature at the Indicated Time Points|Temperature measurements were obtained at the following time points: Screening, Day 1, and Weeks 4, 8, 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Degree Celsius (°C)||Standard Deviation|Mean
153378|NCT00358449|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate measurements were obtained at the following time points: Screening, pre-infusion, 10m, 30m, 1h, 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Beats per minutes||Standard Deviation|Mean
153380|NCT00358449|Primary|Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline|12-lead ECG assessments were obtained at the following time points: screening, and Weeks 4, 8 and 12.. Overall ECG findings were summarized using the worst case findings without regard to visits ie. “any time post Baseline”. Change from Baseline in ECG findings were categorized as clinically significant change from Baseline; no clinically significant change from Baseline and not applicable.|Screening, Weeks 4, 8 and 12|ITT Population||Participants|||Number
153381|NCT00358449|Primary|Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period.|Blood samples were collected pre-infusion at Day 1, Week 4 and Week 8; and 24h and 72h post-infusion at Day 1, Week 4 and Week 8 time points and at Weeks 2, 6, 10, 12, 16, 20, 24, and 34 to estimate the following hematology parameters: basophils (Bas), percentage of basophils (% Bas), lymphocytes (Lym), percentage of Lym (% Lym), monocytes (Mon), percentage of Mon (% Mon), platelet count (PC), total neutrophils (TN), percentage of TN (% TN), white blood cell count (WBC), hematocrit (He), hemoglobin (Hg), and red blood cell count (RBC). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)|ITT Population. Only those participants available at specified time points are analyzed.||Participants|||Number
153382|NCT00358449|Primary|Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period.|Blood samples were collected at Day 1, Weeks 4, 8, 12, 16, 20 and 24 to estimate the following biochemistry parameters: alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (Ab), total protein (ToP), creatinine (Cr), total bilirubin (TB), calcium (Ca), bicarbonate (Bi), chloride (Cl), glucose (Glu), potassium (Pot), and sodium (Sod). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).||Participants|||Number
153383|NCT00358449|Primary|Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE’s were considered to have a reasonable possibility of being related to treatment by the investigator. AE, SAE and drug-related AEs are summarized by TP and FP.|From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)|Intention-to-Treat (ITT) Population: all participants who gave informed consent, were randomized and received at least one dose of medication.||Participants|||Number
153384|NCT00358436|Primary|Trough FEV1 (L) at 12 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks|12 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
153385|NCT00358436|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment|Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Percentage of Patients|||Number
153386|NCT00358436|Secondary|Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment|Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.|52 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Days||95% Confidence Interval|Median
153387|NCT00358436|Primary|Trough FEV1 (L) at 28 Weeks on Treatment|Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks|28 weeks|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.||Liters||Standard Error|Least Squares Mean
153388|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 364 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
153389|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 272 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
153390|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 180 +/- 14 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
153391|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 90 +/- 10 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
153392|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 60 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
153393|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 30 +/- 7 days|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
153394|NCT00358332|Primary|Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.||Participants|||Number
153395|NCT00358332|Secondary|Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0|This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.|Day 0|Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.||log anti-FMP2.1 titer||95% Confidence Interval|Mean
153396|NCT00358332|Primary|Number of Subjects Spontaneously Reporting Any Serious Adverse Event.|Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.|1 year after the last vaccination.|This outcome includes all enrolled subjects.||Participants|||Number
153397|NCT00358332|Primary|Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.|The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.|Day of vaccination and 30 subsequent days.|This outcome includes all enrolled subjects.||Participants|||Number
153398|NCT00358332|Primary|Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.|The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.|7 Days following any vaccination|This outcome includes all enrolled subjects.||Participants|||Number
153399|NCT00358215|Secondary|Change From Baseline to Month 6 in KCCQ Symptom Frequency Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.||units on a scale||Standard Error|Least Squares Mean
153400|NCT00358215|Secondary|Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|Baseline and Month 6|Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score.||units on a scale||Standard Error|Least Squares Mean
153401|NCT00358215|Secondary|Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure|Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat||days||Inter-Quartile Range|Median
153402|NCT00358215|Secondary|Time to Death From Any Cause|Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat||days||Inter-Quartile Range|Median
153403|NCT00358215|Primary|Time to All Cause Death or First Hospitalization for Worsening Heart Failure|Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.|From randomization to the end of study; maximum time on study was 73 months|Intent-to-treat (ITT) analysis set, defined as all randomized participants||days||Inter-Quartile Range|Median
153835|NCT00353652|Primary|Sympathetic Nerve Activity||Measured at 6 months|||bursts/min||Standard Deviation|Mean
153404|NCT00358150|Secondary|Lumbar Spine and Femur Z-Scores for BMD at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||Z-Score||Standard Deviation|Mean
153405|NCT00358150|Secondary|Lumbar Spine and Femur T-Scores for Bone Mineral Density (BMD) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Images of the lumbar spine and femur were obtained by dual energy X-ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-scores compares participant's bone density with that of healthy young participant of same gender. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||T-Score||Standard Deviation|Mean
153406|NCT00358150|Secondary|Bone Marrow Infiltration: Number of Participants With Improvement From Baseline in Dark Marrow at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (EOS)|Bone marrow infiltration assessments were designed to evaluate improvements in dark marrow using MRI. Each MRI assessment was performed for both femurs and consisted of reviewing 6 different zones (the femoral head, greater trochanter, intertrochanteric region, shaft, distal metaphysis, and condyles). MRI images recorded dark marrow for each zone as either present or not present at baseline. In this outcome, number of participants (for whom dark marrow was present at baseline) with improvement from baseline in dark marrow at each specified time point were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and at End of Study (up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ’n’ signifies number of participants who were presented with dark marrow at baseline and had data available at specified time points.||Participants|||Count of Participants
153407|NCT00358150|Secondary|Number of Participants With No Bone Crisis at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with 0= no bone crises levels at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||participants|||Number
153408|NCT00358150|Secondary|Number of Participants With Mobility Status (MS) at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Mobillity, i.e. ability to walk was assessed as a part of Gaucher disease assessment in participants.In this outcome, number of participants with their different mobility status (unrestricted mobility, walks with difficulty) at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||participants|||Number
153409|NCT00358150|Secondary|Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain and moderate bone pain. In this outcome, number of participants with different levels of bone pain at specified time points were reported.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||participants|||Number
153410|NCT00358150|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|The FSS is an instrument consisting of 9 self-administered questions that measures the impact of severity of fatigue symptoms on everyday functioning, based on the recall over the past week. Score range for each question ranges from 1 (minimum) to 7 (maximum), where higher score indicates greater severity. FSS total score was calculated by averaging the results of all questions. Total FSS score ranges from 9 (minimum) to 63 (maximum), where higher scores indicates greater severity.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||units on a scale||Standard Deviation|Mean
153422|NCT00358007|Primary|Average Interfraction Shift of Patients Undergoing Radiotherapy|"Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan.~Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken."|Daily prior to radiation|||millimeters||Standard Deviation|Mean
153559|NCT00356863|Other Pre-specified|Biochemical Markers|glucose, total cholesterol, triglycerides, low density lipoprotein (LDL) cholesterol. Data regarding these biochemical markers was collected from medical available documents at the homes of the patients. In many cases this data was unavailable. Reported values are only available for a subpopulation.|1 year|||mg/dl||95% Confidence Interval|Mean
153411|NCT00358150|Secondary|Change From Baseline in 36-Item Short Form (SF-36) Health Survey Scores at Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8 and Year 9 at End of Study|The SF-36 questionnaire, version 2, investigates the participant’s health-related quality of life (HRQL). It is a 36-item questionnaire measuring 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life. Two summary scale scores were computed from the 8 domain scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranges from 0 (worst) to 100 (best), with higher scores reflecting best health-related quality of life.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||units on a scale||Standard Deviation|Mean
153412|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Chitotriosidase) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
153413|NCT00358150|Secondary|Percent Change From Baseline in Biomarker Chemokine Ligand 18 (CCL18) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
153414|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Tartrate-Resistant Acid Phosphatase [TRAP]) Level at Year 1 and Year 2||Baseline, Year 1, Year 2|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points. As per the change in planned analysis, TRAP was not assessed after Year 2.||percent change||Standard Deviation|Mean
153415|NCT00358150|Secondary|Percent Change From Baseline in Biomarker (Angiotensin Converting Enzyme) Level at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study||Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time point.||percent change||Standard Deviation|Mean
153416|NCT00358150|Secondary|Percent Change From Baseline in Platelet Count at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in platelet count = ([platelet count at specified time points minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
153417|NCT00358150|Secondary|Absolute Change From Baseline in Hemoglobin at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Absolute change = hemoglobin level at specified time points minus hemoglobin level at baseline.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||g/dL||Standard Deviation|Mean
153418|NCT00358150|Secondary|Percent Change From Baseline in Liver Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in liver volume = ([liver volume at specified time points minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here ‘n’ signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
153419|NCT00358150|Secondary|Percent Change From Baseline in Spleen Volume at Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study|Percent change in spleen volume = ([spleen volume at specified time points minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and at End of Study (Up to Year 9)|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat. Here 'n' signifies number of participants with available data at specified time points.||percent change||Standard Deviation|Mean
153420|NCT00358150|Primary|Percentage of Participants Demonstrating A Meaningful Clinical Response|A meaningful clinical response was defined as an improvement in at least 2 of the 3 main efficacy parameters: a) an increase in hemoglobin of greater than or equal to (>=) 0.5 gram/deciliter from baseline, b) an increase in platelets of >=15 percent (%) from baseline, c) reduction in total spleen volume of >= 15% from baseline. As hemoglobin, platelets, total spleen volume were abnormal at baseline, within each participant, only those parameters were used in the evaluation of meaningful clinical response which were abnormal at baseline.|Baseline, Year 1|Full analysis set consists of all participants who signed informed consent and received at least one dose of eliglustat.||percentage of participants|||Number
153421|NCT00358007|Primary|Average Residual Error Motion of Patients Undergoing Radiotherapy|To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms|Daily after each radiotherapy treatment|||millimeters||Standard Deviation|Mean
153892|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method|||||
153423|NCT00357994|Secondary|Employment Impairment (EMP) II Status at Week 12|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument.|Week 12 (or early termination)|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
153424|NCT00357994|Secondary|Employment Impairment (EMP) I Status at Baseline|The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?).|Baseline|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. Missing data was not imputed.||participants|||Number
153425|NCT00357994|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0–100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153426|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153427|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. Questions 32, 33, and 34 on UPDRS Part IV were totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
153428|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0–4) or a 2-point scale (0 or 1). The Part IV score ranges from 0–23 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153429|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment. No missing data was imputed.||units on a scale||Standard Error|Least Squares Mean
153430|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153431|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153439|NCT00357994|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153432|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153433|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153434|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153435|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153436|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153437|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153438|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153462|NCT00357968|Secondary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100.|2 hours after loading dose|Includes all patients who received a loading dose of study drug, did not receive a GP IIb/IIIa antagonist and had evaluable pretreatment and 2 hour MPA measurements. Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing.||percent inhibition||Standard Deviation|Mean
153440|NCT00357994|Secondary|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153441|NCT00357994|Secondary|Change From Baseline in UPDRS Part III Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153442|NCT00357994|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153443|NCT00357994|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Deviation|Mean
153444|NCT00357994|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||units on a scale||Standard Error|Least Squares Mean
153445|NCT00357994|Secondary|"Change From Baseline in Average Daily Normalized On Time Without Troublesome Dyskinesia at Week 12"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
153446|NCT00357994|Primary|"Change From Baseline to Week 12 in Average Daily Normalized Off Time"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Week 12|Full Analysis Set: randomized participants who had the study device implanted and had data for baseline and at least 1 post-baseline assessment.||hours||Standard Error|Least Squares Mean
153447|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose|Mean troponin level at 18 to 24 hours after the loading dose. Troponin is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.||ng/ml||Standard Deviation|Mean
153448|NCT00357968|Secondary|Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose|Mean troponin level at 6 hours after the loading dose. Troponin is a biomarker for myonecrosis.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable troponin measure.||ng/ml||Standard Deviation|Mean
153449|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose|Mean CK-MB at 18-24 hours after loading dose. CK-MB is a biomarker for myonecrosis.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.||IU/L||Standard Deviation|Median
153450|NCT00357968|Secondary|Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose|Mean CK-MB at 6 hours after loading dose. CK-MB is a biomarker for myonecrosis|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had an evaluable CK-MB measure.||IU/L||Standard Deviation|Mean
153451|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|after 14 days of maintenance dosing|Includes patients who received a loading dose and PCI, regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)||percent (%) platelet reactivity index||Standard Deviation|Mean
153452|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index. A lower PRI indicates greater antiplatelet effect.|18 to 24 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements.||percent (%) platelet reactivity index||Standard Deviation|Mean
153453|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|6 hours after loading dose|Includes patients who received a loading dose, underwent PCI, and had evaluable VASP measurements, and did not receive a GP IIb/IIIa antagonist. Patients had received a single loading dose but had not yet received any maintenance treatment.||percent (%) platelet reactivity index||Standard Deviation|Mean
153454|NCT00357968|Secondary|Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose|VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI). PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index. A lower PRI indicates greater antiplatelet effect.|2 hours after loading dose|Includes patients who received a loading dose, underwent PCI, did not receive a GP IIb/IIIa antagonist, and had evaluable VASP measurements. Patients had received a single loading dose but had not yet received any maintenance treatment.||percent (%) platelet reactivity index||Standard Deviation|Mean
153455|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|14 days after cross-over|Includes patients who received a single loading dose and had evaluable MPA measures,regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients received 14 days of maintenance treatment and then crossed-over to the alternate maintenance treatment for 14 days.||participants|||Number
153456|NCT00357968|Secondary|Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|From loading dose to day 15|Includes patients who received a single loading dose and had evaluable MPA measures, regardless of glycoprotein (GP) IIb/IIIa antagonist use. Patients had received 14 days of maintenance treatment but had not crossed-over to the alternate maintenance treatment.||participants|||Number
153457|NCT00357968|Secondary|Number of Hyporesponsive Participants at 6 Hours After the Loading Dose|Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%|6 hours after loading dose|"Includes patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist and had evaluable pre-treatment, and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."||participants|||Number
153458|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|14 days after cross-over|Includes all patients who received a loading dose and underwent PCI, received a maintenance dose for 14 days, and then crossed-over to the alternate therapy for an additional 14 days of maintenance dosing.||participants|||Number
153459|NCT00357968|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase|Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization|after 14 days of treatment (before cross-over)|Includes all patients who received a loading dose. Patients who underwent PCI also received 14 days of maintenance treatment. Patients had not yet crossed-over to the alternate maintenance treatment.||participants|||Number
153460|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|14 days after cross-over|All patients who received a loading dose of study drug, received maintenance therapy for 14 days and then switched to the alternate maintenance therapy.||participants|||Number
153461|NCT00357968|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase|"Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL.~Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL."|after 14 days of treatment (before cross-over)|Patients received a single loading dose and 14 days of maintenance therapy. Patients had not yet crossed-over to the alternate maintenance dose.||participants|||Number
153484|NCT00357903|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps|Up to 10 years|All participants who received at least one dose of etanercept||Participant-years|||Number
153463|NCT00357968|Primary|Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment|"Measures IPA during maintenance dosing before and after cross-over for each therapy.~IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100."|after 14 days of maintenance dosing|Includes patients who received a loading dose and underwent percutaneous coronary intervention (PCI) regardless of GP IIb/IIIa antagonist use (this includes subjects who received prasugrel and clopidogrel, in either order, during crossover)||percent inhibition||Standard Deviation|Mean
153464|NCT00357968|Primary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose|IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.|6 hours after loading dose|"Consists of all patients who received a loading dose of the study drug, did not receive a glycoprotein (GP) IIb/IIIa antagonist, and had evaluable pre-treatment and 6 hour MPA measurements.~Patients had received a single loading dose of either 60-mg prasugrel or 600-mg clopidogrel but had not yet received any maintenance dosing."||percent inhibition||Standard Deviation|Mean
153465|NCT00357955|Primary|Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg|The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L).|4 months|||percentage|||Number
153466|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 10 years|All participants who received at least one dose of etanercept||Events per 100 participant-years|||Number
153467|NCT00357903|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system.|up to 10 years|All participants who received at least one dose of etanercept||Observed count / expected count|||Number
153468|NCT00357903|Secondary|JRA DOI 30 at Month 3 in Juveniles|Juvenile Rheumatoid Arthritis Definition of Improvement 30 (JRA DOI 30), defined as a 30% improvement from baseline in 3 of 6 items (including Childhood Health Assessment Questionnaire, disease severity, overall well-being, and erythrocyte sedimentation rate) and a worsening of >30% in at most one of the remaining items.|Baseline and month 3|All participants who received at least one dose of etanercept and were evaluable for this endpoint at 3 months||Participants|||Number
153469|NCT00357903|Secondary|ACR20 at Month 3 in Adults|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 3|All participants who received at least one dose of etanercept and had available data at both baseline and month 3||Participants|||Number
153470|NCT00357903|Secondary|C-Reactive Protein|C-reactive protein at month 12|Month 12|All participants who received at least one dose of etanercept and had available data||mg/dL||Standard Deviation|Mean
153471|NCT00357903|Secondary|Childhood Health Assessment Questionnaire|Childhood Health Assessment Questionnaire (CHAQ) disability index, having a range of 0 (no difficulty) to 3 (unable to do).|Month 12|All participants who received at least one dose of etanercept and had available data||Units on a scale||Standard Deviation|Mean
153472|NCT00357903|Secondary|Health Assessment Questionnaire Disability Index|Health Assessment Questionnaire Disability Index (HAQ DI). This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).|Month 12|All participants who received at least one dose of etanercept and had available data||Units on a scale||Standard Deviation|Mean
153473|NCT00357903|Secondary|Swollen Joint Count|Number of swollen joints|Month 12|All participants who received at least one dose of etanercept and had available data||Joints||Standard Deviation|Mean
153474|NCT00357903|Secondary|Tender Joint Count|Number of tender joints, as assessed by the investigator using criteria based on pressure and joint manipulation|Month 12|All participants who received at least one dose of etanercept and had available data||Joints||Standard Deviation|Mean
153475|NCT00357903|Primary|Death|Occurrence of death on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
153476|NCT00357903|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
153477|NCT00357903|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
153478|NCT00357903|Primary|Malignancy|Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Participants|||Number
153479|NCT00357903|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Lymphomas per 100 participant-years|||Number
153480|NCT00357903|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Events per 100 participant-years|||Number
153481|NCT00357903|Primary|Total Exposure Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Deaths per 100 participant-years|||Number
153482|NCT00357903|Primary|Total Exposure Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 10 years|All participants who received at least one dose of etanercept||Malignancies per 100 participant-years|||Number
153483|NCT00357903|Secondary|Dosing Period|Duration of etanercept dosing|Up to 10 years|All participants who received at least one dose of etanercept||Days||Standard Deviation|Mean
153485|NCT00357734|Primary|Number of Other Adverse Events (AEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||number of other AEs related to ZD1839|||Number
153486|NCT00357734|Primary|Number of Other Adverse Events (AEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||number of other AEs|||Number
153487|NCT00357734|Primary|Number of Serious Adverse Events (SAEs) Related to ZD1839|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease.|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||Number of SAEs related to ZD1839|||Number
153488|NCT00357734|Primary|Number of Serious Adverse Events (SAEs)|Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator’s opinion, the condition is unlikely to resolve because of the patient’s underlying disease|Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)|||number of SAEs|||Number
153489|NCT00357734|Secondary|Overall Survival (OS)||From randomization until death (up to 120 months)|||Months||95% Confidence Interval|Median
153490|NCT00357734|Secondary|Progression-free Survival (PFS)|Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From randomization until progression or death (up to 120 months)|||Months||95% Confidence Interval|Median
153491|NCT00357552|Secondary|Change in CD4+ Cell Counts From Study Entry to Week 104||Study entry and week 104|All participants enrolled.||cells/mm^3||Inter-Quartile Range|Median
153492|NCT00357552|Secondary|Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104||At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104|All participants enrolled.||proportion of participants|||Number
153493|NCT00357552|Secondary|HIV-1 Viral Sequence as Ascertained From Paired DBS and Plasma||At study entry and virologic failure||06/2016||||
153494|NCT00357552|Secondary|Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma||At study entry and weeks 24 and 48||06/2016||||
153495|NCT00357552|Secondary|Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification|25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From LPV/r intensification to week 104|All participants enrolled.||weeks||95% Confidence Interval|Number
153496|NCT00357552|Secondary|Percentage of Subjects Reporting Not Skipping Medications in the Last Month.|The percentage of subjects reporting never missing medications in the last month.|Study entry and weeks 2, 4, 8, 12, 16, 20, and 24|All participants enrolled.||percentage of subjects with data|||Number
153497|NCT00357552|Secondary|Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.|Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm.|At time of virologic failure|16 subjects met the criteria for endpoint failure; 15 subjects were virologic failures and 1 subject intensified prior to virologic failure. Of the 15 subjects with virologic failure, 11 had sequence data, and sequencing failed for 4.||participants|||Number
153498|NCT00357552|Secondary|Number of Participants With Study-targeted Diagnoses and Clinical Events|Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair.|Study entry to week 104|All participants enrolled.||participants|||Number
153499|NCT00357552|Secondary|Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.|25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy.|Study entry to Week 104|All participants enrolled.||weeks||95% Confidence Interval|Number
153500|NCT00357552|Secondary|Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.|Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm.|Screening|All screened individuals.||number of screened subjects|||Number
153541|NCT00357006|Secondary|Cognitive Performance (RBANS Scores)||baseline and week 8||||||
153501|NCT00357552|Primary|Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.|Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to week 24|All enrolled individuals.||cumulative probability of grade 3 or 4||95% Confidence Interval|Number
153502|NCT00357552|Primary|Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy|Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL.|From study entry to week 24|All enrolled individuals.||percentage of enrolled subjects||90% Confidence Interval|Number
153503|NCT00357500|Secondary|Best Response|As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); >/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); <50% decrease and <25% increase in product of diameters, stable disease (SD); and >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.|||participants|||Number
153504|NCT00357500|Secondary|27-Week Overall Survival|27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.||Probability||95% Confidence Interval|Number
153505|NCT00357500|Secondary|27-Week Progression-Free Survival|27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.|The analysis dataset is comprised of all treated patients.||Probability||95% Confidence Interval|Number
153506|NCT00357500|Primary|Therapy Completion Rate|Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as >/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as >/=25% or >/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.|27 weeks|The analysis dataset is comprised of all treated patients.||proportion of patients||90% Confidence Interval|Number
153507|NCT00357396|Primary|Overall Objective Response||2 years|||participants|||Number
153508|NCT00357162|Secondary|Toxicity of Belinostat in Patients With Myelodysplastic Syndrome|Graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Reporting events deemed at least possibly related to study treatment.|Prior to each course (every 21 days), and every 3 months for up to 3 years after completion of study treatment|||participants|||Number
153509|NCT00357162|Secondary|Duration of Response|Estimated using the method of Kaplan-Meier.|From the date of documented response until the date of progression or last follow-up, assessed up to 3 years|One participant had a confirmed Hematologica Improvement. For patient confidentiality, we are not reporting response data.|||||
153510|NCT00357162|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From date of registration to the date of last follow-up or death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
153511|NCT00357162|Secondary|Time to Progression|Estimated using the method of Kaplan-Meier.|Time from registration to the date of progression or last follow-up, assessed up to 3 years|||months||95% Confidence Interval|Median
153512|NCT00357162|Primary|Number of Confirmed Responses (Complete Response, Partial Response, or Hematologic Improvement) Noted on 2 Consecutive Evaluations at Least 4 Weeks Apart|"Complete Response (CR)~A CR is defined as a participant with bone marrow showing less than 5% myeloblasts with no evidence of dysplasia and with adequate peripheral blood counts for at least 2 months (hemoglobin > 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3) and with no blasts in the peripheral.~Partial Response (PR)~All the CR criteria except bone marrow blasts decreased by ≥ 50% over pretreatment, or a less advanced WHO classification than pretreatment.~Hematologic Improvement (HI)~A 2g/dl increase in hemoglobin for participants with <11g/dl hemoglobin at pretreatment, or an increase of >30,000/mm^3 platelets for participants with <100,000/mm^3 at pretreatment, or a 100% increase in neutrophil counts for participants with <1500/mm^3 at pretreatment"|12 weeks|||participants|||Number
153513|NCT00357110|Primary|Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)|Number of patients event-free|12 month period following randomisation|||Participants|||Number
153514|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Quantity” (Hours) of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks||Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
153558|NCT00356863|Other Pre-specified|Medical Service Utilization|Visits to the emergency department during the year following CABG surgery|1 year|||ER visits|||Number
153515|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
153516|NCT00357097|Secondary|Change From Average Baseline Scores of Subscale “Sleep Disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
153517|NCT00357097|Secondary|Change From Average Baseline Score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks|Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.|Baseline and after Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
153518|NCT00357097|Secondary|Percentage of Participants With “Much Improved” or “Very Much Improved” on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score range: 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5- minimally worse, 6-much worse, to 7-very much worse.|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Percentage of Participants|||Number
153519|NCT00357097|Secondary|Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Percentage of Participants|||Number
153520|NCT00357097|Secondary|Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks|International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points|Baseline, Week 1, Week 4, Week 12|Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)||Score on a Scale||Standard Deviation|Mean
153521|NCT00357097|Secondary|Change in Average BDI Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 91 and Placebo 34. High/Low BDI scores for this population were 46/2.||Score on a Scale||Standard Deviation|Mean
153522|NCT00357097|Secondary|Change in Average HAM-D Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 90 and Placebo 31.||Score on a Scale||Standard Deviation|Mean
153523|NCT00357097|Secondary|Change in Average MADRS Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 93 and Placebo 34||Score on a Scale||Standard Deviation|Mean
153524|NCT00357097|Secondary|Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline in Subjects With Signs of at Least Moderate Depression at Baseline (MADRS Score >= 18)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29||Percentage of Participants|||Number
153893|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153525|NCT00357097|Secondary|Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5).||Percentage of Participants|||Number
153526|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15.||Percentage of Participants|||Number
153527|NCT00357097|Secondary|Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12).||Percentage of Participants|||Number
153528|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Mild-moderate Depression (BDI >= 21) at Baseline|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with BDI scores>=21: Ropinirole 75 and Placebo 28. High/Low BDI scores for this population were 46/2.||Score on a Scale||Standard Deviation|Mean
153529|NCT00357097|Secondary|Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). High/Low BDI scores for this population were 46/2.||Score on a Scale||Standard Deviation|Mean
153530|NCT00357097|Secondary|Average Change of the HAM-D Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Moderate Depression (HAM-D Score >= 15) at Baseline|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54(severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores>=15: Ropinirole 93 and Placebo 33||Score on a Scale||Standard Deviation|Mean
153531|NCT00357097|Secondary|Average Change of the HAM-D (Hamilton Depression Rating Scale, 17-item-Version) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low HAM-D scores for this population were 27/5.||Score on a Scale||Standard Deviation|Mean
153532|NCT00357097|Secondary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of at Least Moderate Depression (MADRS Score: >=18)|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores>=18: Ropinirole 91 and Placebo 29. The high/Low scores for the mITT population were 32/11.||Score on a Scale||Standard Deviation|Mean
153533|NCT00357097|Primary|Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment|Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.|Baseline and Week 12|Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low scores for this population were 32/11.||Score on a Scale||Standard Deviation|Mean
153534|NCT00357032|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to 1 year||||||
153535|NCT00357032|Secondary|Duration of Response||Up to 1 year||||||
153536|NCT00357032|Secondary|Overall Survival|Survival endpoints will be summarized by the method of Kaplan-Meier|Up to 1 year|||Months||95% Confidence Interval|Median
153537|NCT00357032|Primary|Complete Response Rate|Clinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles.|Up to 1 year|||percentage of subjects|||Number
153538|NCT00357006|Secondary|Change in Hormone Levels Over Trial Duration||Baseline and weeks 1, 4 and 8.||||||
153539|NCT00357006|Secondary|Scores on Adverse Symptom Checklist at Trial Completion||Baseline and weeks 1, 2, 4, 6, 8||||||
153540|NCT00357006|Secondary|Scores on MADRS at Trial Completion||Baseline and week 8||||||
153542|NCT00357006|Primary|Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.|Baseline and week 8|||units on a scale||Standard Deviation|Mean
153543|NCT00356915|Secondary|Clinical Improvement Compared to Placebo|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.~The Investigator's Global Assessment(IGA)assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.~0 = Clinical Cure: No evidence of onychomycosis.~1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months|Intent to treat (ITT)||percentage of participants|||Number
153544|NCT00356915|Secondary|Clinical Improvement of the Target Toenail|"Clinical Improvement consisted of a mycological cure and an Investigator's Global Assessment (IGA) score less than or equal to 1 at week 52.~The Investigator’s Global Assessment (IGA) assesses the overall severity of onychomycosis on the target toenail and takes into consideration, onycholysis, hyperkeratosis and percent nail involvement.~0 = Clinical Cure: No evidence of onychomycosis.~1 = Clinical Improvement: Minimal evidence of onychomycosis. 2 = Mild: ≤25% dystrophy and/or onycholysis. 3 = Moderate: ≤50% dystrophy with onycholysis. 4 = Severe: >50% dystrophy with onycholysis."|12 months|||percentage of participants|||Number
153545|NCT00356915|Primary|Complete Cure - Itraconazole Tablets Compared to Itraconazole Capsules|The primary efficacy endpoint was Compete Cure (consisting of a Clinical Cure and a Mycological Cure) at week 52. In this study, Clinical Cure was defined as an Investigator’s Global Assessment (IGA) score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) examination and a negative culture outcome for dermatophytes of the target toenail. The efficacy analyses were conducted to demonstrate the non-inferiority of 1 itraconazole 200-mg tablet to 2 itraconazole 100-mg capsule.|12 months|Intent to treat (ITT).||Percentage of participants|||Number
153546|NCT00356915|Primary|Clinical and Mycological Cure of Target Toenail|"This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets.~Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail."|1 year|Intent to treat (ITT).||Percentage of participants|||Number
153547|NCT00356889|Secondary|Duration of Response|Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987).|From the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years|There were 6 patients with a confirmed Partial Response.||months||95% Confidence Interval|Median
153548|NCT00356889|Secondary|Time to Disease Progression|Estimated using the method of Kaplan-Meier (1958).|From registration to documentation of disease progression, assessed up to 3 years|||months||95% Confidence Interval|Median
153549|NCT00356889|Secondary|Survival Time|Estimated using the method of Kaplan-Meier (1958).|From registration to death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
153550|NCT00356889|Primary|Number of Confirmed Tumor Responses.|"Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions.~A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint."|After 6 courses of treatment. Each course lasts 28 days.|||participants|||Number
153551|NCT00356863|Other Pre-specified|Blood Pressure|The pooled mean of 3 blood pressure measurements taken during the interview|1 year follow up|||mm Hg||95% Confidence Interval|Mean
153552|NCT00356863|Secondary|MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.|MacNew questionnaire (MACNEW). A self-administered heart disease-specific health-related quality of life (HRQL) instrument. The MacNew is a modification of the original interviewer-administered Quality of Life after Myocardial Infarction [QLMI] instrument. It addresses three major HRQL domains, the Emotional, Physical, and Social domains which can be combined to give a Global HRQL score. The MacNew consists of 27 items. The total mean score ranges between 1 and 7, where higher score means better HRQL.|1 year|The N for this outcome is the number of patients for whom there are follow-up data after one year.||Scores on a scale||Standard Deviation|Mean
153553|NCT00356863|Other Pre-specified|Physical Activity|"Self-reported physical activity using a physical activity questionnaire validated in Hebrew. Details of the study validating the instrument: Development of a Hebrew questionnaire to be used in epidemiological studies to assess physical fitness--validation against sub maximal stress test and predicted VO2max. Ken-Dror G, Lerman Y, Segev S, Dankner R. Harefuah. 2004 Aug;143(8):566-72, 623. Hebrew. PMID: 15523807 VO2max=maximal oxygen uptake"|1 year|All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire||patients|||Number
153554|NCT00356863|Other Pre-specified|Depression & Anxiety|Score in the HADS (hospital Anxiety and Depression Scale) screening for anxiety and depression. This is a 14 item scale, 7 items for anxiety and 7 items for depression. Each item can score 0-3 (0=good, 3=bad) and the total score for each scale varies between 0 (no depression/anxiety) to 21 (clinical depression/anxiety requiring medical intervention)|1 year|All patients who completed the Hospital Anxiety and Depression Scale (HADS)||HADS score||Standard Deviation|Mean
153555|NCT00356863|Other Pre-specified|Employment Status|Number of patients fully employed in each arm|1 year|||patients|||Number
153556|NCT00356863|Other Pre-specified|Lifestyle Habits (i.e. Smoking)||1 year|||patients|||Number
153557|NCT00356863|Other Pre-specified|Anthropometric Measures|Measurements of body mass index (BMI)|1 year|||kg/m^2||95% Confidence Interval|Mean
153560|NCT00356863|Other Pre-specified|Cardiovascular Morbidity|All hospitalizations which occured during the 1 year follow-up and were due to acute myocardial infarction (International Classification of Disease 9th version (ICD-9) codes 410.), angina pectoris (ICD-9 codes 413.9), stroke/ transient ischemic attack (TIA) (ICD-9 codes 436.), and all surgical procedures which occured during the 1 year follow-up: CABG or coronary catheterizations (ICD-9 codes 36.), endarterectomies (ICD-9 codes 38.0 and 39.0).|1 year|All patients who were exposed to the educational intervention at baseline and who were contacted a year later and gave information regarding participation in cardiac rehabilitation during the follow up year.||events|Participants||Number
153561|NCT00356863|Primary|Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups|The number of cardiac patients who participated in cardiac rehabilitation programs during the year following coronary artery bypass grafting surgery in the control and the intervention groups.|1 year|All patients alive at 1-year follow up who gave information on participation in cardiac rehabilitation programs (CRPs) at any time during the year following surgery (and before follow up assessment). This information was obtained via a face-to-face interview or by telephone interview.||participants|||Number
153562|NCT00356811|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the start of study medication until 28 days after the last dose (up to Study Week 381)|ITT Population||Participants|||Number
153563|NCT00356811|Secondary|Overall Survival|Overall survival is defined as the interval between the date of treatment start and the date of death due to any cause. For participants who did not die, follow-up was censored as the date of last contact. For participants who did not die, follow-up was censored at the date of last contact.|From the date of the first dose until the date of death due to any cause (up to Week 86)|ITT Population||weeks||95% Confidence Interval|Median
153564|NCT00356811|Secondary|Progression-free Survival, as Assessed by the IRC and the Investigator|Progression-free survival is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to any cause, whichever occurs first. Participants who did not progress in their disease were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or death due to any cause, whichever occurs first (up to Week 86)|ITT Population||weeks||95% Confidence Interval|Median
153565|NCT00356811|Secondary|Time to Progression, as Assessed by the IRC and the Investigator|Time to progression is defined as the interval between the start date of treatment and the date of radiological disease progression or death due to breast cancer, whichever occurs first. Participents who did not progress or die were censored on the date of their last radiological assessment preceding the start of any additional anti-cancer therapy. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at a subsequent assessment made no less than 28 days after the original response.|From the start date of treatment until the date of radiological disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population||weeks||95% Confidence Interval|Median
153566|NCT00356811|Secondary|Time to Response, as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||Weeks||95% Confidence Interval|Median
153567|NCT00356811|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From randomization until the first documented evidence of a PR or CR (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||weeks||95% Confidence Interval|Median
153577|NCT00356590|Secondary|Percent Improvement in C-Reactive Protein From Baseline to Month 12|Percent improvement in C-reactive protein from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153894|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153568|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||Weeks||95% Confidence Interval|Median
153569|NCT00356811|Secondary|Duration of Response (DoR), as Assessed by the IRC|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Week 86)|ITT Population. Only those participants with CR or PR were analyzed.||weeks||95% Confidence Interval|Median
153570|NCT00356811|Secondary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per RECIST. The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the Investigator. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|ITT Population||Participants|||Number
153571|NCT00356811|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a CR or PR, per Response Evaulation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the first dose of study medication to the first documented evidence of a confirmed CR or PR (up to Week 86)|Intent-to-Treat (ITT) Population: all participants who received study medication.||Participants|||Number
153572|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale|Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2||Units on a scale||Full Range|Mean
153573|NCT00356590|Secondary|Change From Baseline to Year 2 in Sharp Score Erosion Subscale|Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2||Units on a scale||Full Range|Mean
153574|NCT00356590|Secondary|Change From Baseline to Year 2 in Total Sharp Score|Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Year 2|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2||Units on a scale||Full Range|Mean
153575|NCT00356590|Primary|Death|Death of the participant on study up to 30 days after the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
153576|NCT00356590|Secondary|Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12|Percent improvement in the duration of morning stiffness from baseline to month 12|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153626|NCT00356304|Secondary|Treatment Retention||Measured at Month 5||||||
153895|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153578|NCT00356590|Secondary|Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12|Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153579|NCT00356590|Secondary|Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12|Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153580|NCT00356590|Secondary|Percent Improvement in HAQ DI From Baseline to Month 12|Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153581|NCT00356590|Secondary|Percent Improvement in Swollen Joint Count From Baseline to Month 12|Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153582|NCT00356590|Secondary|Percent Improvement in Tender Joint Count From Baseline to Month 12|Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153583|NCT00356590|Secondary|Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12|"Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from no pain (0 cm) to severe pain (10 cm)."|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153584|NCT00356590|Secondary|Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and Month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153585|NCT00356590|Secondary|Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12|Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12||Percent change||Standard Deviation|Mean
153586|NCT00356590|Secondary|Standardized Incidence Rate for All SEER Cancers|Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.|Up to 8 years|All participants who received at least one dose of etanercept||Standardized incidence rate||95% Confidence Interval|Mean
153587|NCT00356590|Secondary|ACR70 Response at Month 12|American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12||Participants|||Number
153588|NCT00356590|Secondary|ACR50 Response at Month 12|American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12||Participants|||Number
153589|NCT00356590|Secondary|ACR20 Response at Month 12|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults|Baseline and month 12|All enrolled participants who received at least one dose of etanercept and had available data at month 12||Participants|||Number
153590|NCT00356590|Secondary|Dosing Period|Duration of etanercept dosing|Up to 8 years|All participants who received at least one dose of etanercept||Days||Standard Deviation|Mean
153591|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Adverse Events|Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Events per 100 patient-years|||Number
153592|NCT00356590|Primary|Serious Infectious Event|Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
153593|NCT00356590|Primary|Lymphoma|Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
153594|NCT00356590|Primary|Malignancy|Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participants|||Number
153595|NCT00356590|Primary|Total Exposure Adjusted Rate of Lymphomas|Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Lymphomas per 100 participant-years|||Number
153896|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153596|NCT00356590|Primary|Total Exposure Adjusted Rate of Serious Infectious Events|Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Events per 100 participant-years|||Number
153597|NCT00356590|Primary|Total Exposure-Adjusted Rate of Deaths|Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Deaths per 100 participant-years|||Number
153598|NCT00356590|Primary|Total Exposure-Adjusted Rate of Malignancies|Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Malignancies per 100 participant-years|||Number
153599|NCT00356590|Secondary|ACR20 Response at Month 3|American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)|Baseline and month 3|All enrolled participants who received at least one dose of etanercept and had available data at month 3||Participants|||Number
153600|NCT00356590|Primary|Total Exposure to Etanercept With Gaps|Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.|Up to 8 years|All enrolled participants who received at least one dose of etanercept||Participant-years|||Number
153601|NCT00356525|Secondary|Time to Treatment Failure||baseline to stopping treatment (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.||months||Standard Deviation|Mean
153602|NCT00356525|Secondary|Duration of Response||time of response to progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.||months||Standard Deviation|Mean
153603|NCT00356525|Secondary|Time to Progressive Disease||baseline to measured progressive disease (up to 17.5 months)|Outcome measure was not analyzed due to insufficient data.||months||Standard Deviation|Mean
153604|NCT00356525|Secondary|Overall Survival|Overall survival is the number of participants who were alive when the trial was terminated.|baseline to trial termination (17.5 months)|Number of randomized participants in each category.||participants alive|||Number
153605|NCT00356525|Primary|Objective Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to time of response (up to 17.5 months)|Number of randomized participants in each category.||participants|||Number
153606|NCT00356421|Other Pre-specified|Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||scores on scale|||Number
153607|NCT00356421|Secondary|Change in Fasting Lipids From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl||Standard Deviation|Mean
153608|NCT00356421|Other Pre-specified|Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 6, 24, and 52 or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||scores on scale|||Number
153609|NCT00356421|Secondary|Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl|||Number
153610|NCT00356421|Secondary|Change From Baseline in Prandial Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||IU||Standard Deviation|Mean
153611|NCT00356421|Secondary|Change From Baseline in Basal Insulin Doses|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||International Units (IU)||Standard Deviation|Mean
153640|NCT00356148|Secondary|Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).||1 month|||Monetary unit in Turkish Liras||Standard Error|Mean
153612|NCT00356421|Secondary|Change From Baseline in Body Mass Index|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||kilograms per meter squared (kg/m2)||Standard Deviation|Mean
153613|NCT00356421|Secondary|Change From Baseline in Body Weight|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||kg||Standard Deviation|Mean
153614|NCT00356421|Secondary|Change From Baseline in Insulin Antibody Levels|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 24 and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||ml||Standard Deviation|Mean
153615|NCT00356421|Secondary|Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl||Standard Deviation|Mean
153616|NCT00356421|Secondary|Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|To 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||mg/dl||Standard Deviation|Mean
153617|NCT00356421|Secondary|Change From Baseline in FPG|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks or last observation|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||milligrams per deciliter (mg/dl)||Standard Deviation|Mean
153618|NCT00356421|Secondary|Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
153619|NCT00356421|Secondary|Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
153620|NCT00356421|Secondary|Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
153621|NCT00356421|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)|As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.|At 52 weeks|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.||percent|||Number
153622|NCT00356408|Secondary|Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.|Crohn’s disease activity index (CDAI) is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.|Week 34 in this study|All subjects in the the Intent to Treat (ITT) population are included in this analysis.||percentage of subjects|||Number
153623|NCT00356408|Primary|Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)|Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.|During this study (maximum 122 weeks)|All subjects in the the Intent to Treat (ITT) population are included in this analysis.||subjects|||Number
153624|NCT00356304|Secondary|Medication Attitudes||Measured at Month 5||||||
153625|NCT00356304|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.~0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression. Higher total scores indicate more severe depressive symptoms."|Measured at Month 5|||units on a scale||Standard Error|Mean
153627|NCT00356304|Primary|Medication Adherence, as Measured by Electronic Pill Container|Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.|Measured immediately post-treatment and at Months 2 and 5 months follow-ups|We used an ITT with LOCF. These figures represent outcomes at 5 months.||Percentage of Days||Standard Error|Mean
153628|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153629|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153630|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153631|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153632|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 12|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153633|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 6|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153634|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Month 3|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153635|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Posttreatment, 8 weeks|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153636|NCT00356278|Secondary|PTSD Symptom Scale Self-Report|PTSD Symptom Scale – Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153637|NCT00356278|Primary|Clinician-Administered PTSD Scale (CAPS)|Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.|Baseline|Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data||units on a scale||95% Confidence Interval|Mean
153638|NCT00356200|Primary|Change in Target Lesion Score at Week 4 Compared to Baseline|Change in score from 0-14 of target lesion disease activity based on scaling, erythema, and induration as determined by a physician assessor at week 4 compared to baseline (with 0 being no disease activity and 14 being maximum disease activity).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4||units on a scale||Standard Deviation|Mean
153639|NCT00356200|Secondary|Change in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 4 Compared to Baseline.|Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 4 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).|Baseline to week 4|all 5 patients per cohort completed the visit at week 4||mm||Standard Deviation|Mean
153642|NCT00356135|Secondary|Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria|Bleeding events were classified as Major Bleeding, Minor Bleeding, or Insignificant according to TIMI criteria. Major Bleeding: any intracranial hemorrhage OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 gm/dL from baseline. Minor Bleeding: any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Insignificant Bleeding: any bleeding event that does not meet criteria for a Major or Minor Bleed.|End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug|Safety Population - all randomized participants.||Participants|||Number
153643|NCT00356135|Secondary|Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week|Correlation Coefficient comparing the Accumetrics VerifyNow™ P2Y12 device with light transmittance aggregometry (LTA) for monitoring platelet aggregation.|1 week after randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||correlation coefficient|||Number
153644|NCT00356135|Secondary|Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Residual platelet aggregation after the addition 5 and 20 micromolar ADP as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||percent residual platelet aggregation||Standard Deviation|Mean
153645|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event|Data provided are the MPA to 20 micromolar ADP while taking clopidogrel (measurement taken at end of the 14 day open label phase) grouped by subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event.|End of 14 day open label|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA. Grouped according to clopidogrel use at time of ACS event and no clopidogrel use at time of ACS event.||percent maximum platelet aggregation (%)||Standard Deviation|Mean
153646|NCT00356135|Secondary|Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks|Maximum platelet aggregation (MPA) to 5 and 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug|Pharmacodynamic Population, which included all randomized participants who had blood draws for MPA, who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||percent maximum platelet aggregation (%)||Standard Deviation|Mean
153647|NCT00356135|Primary|Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)|Maximum platelet aggregation (MPA) to 20 micromolar adenosine diphosphase (ADP) as measured with light transmittance aggregometry (LTA).|1 week after first dose of randomized study drug|The primary analysis population was the pharmacodynamic (PD) population which included all randomized participants who had blood draws for MPA at 1 week after randomization who met compliance criteria, and who had last dose of study drug the day prior to the blood draw for MPA.||percent maximum platelet aggregation (%)||Standard Error|Least Squares Mean
153648|NCT00356122|Secondary|Number of Participants With Treatment-related Toxicities|"Treatment-related toxicities were serious and non-serious adverse events (AE) considered related to study treatment by the investigator.~AEs were any unfavorable and unintended signs, symptoms, syndromes, or illnesses that developed or worsened during the observation period, and included abnormal results from diagnostic procedures. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, appeared as a congenital anomaly or were considered medically important by the investigator."|From baseline up to 30 days after treatment discontinuation|All participants who received at least one dose of study treatment||Participants|||Number
153649|NCT00356122|Secondary|Overall Survival (OS)|OS was measured from the date of registration to the date of death due to any cause, or to the date of last contact (for censored observations). OS was assessed by the Kaplan-Meier method and the estimates of median survival time with 95% CI are reported.|Baseline to OS (up to 24 months after the first treatment)|All participants registered to receive study treatment||Months||95% Confidence Interval|Median
153650|NCT00356122|Secondary|Time-to-treatment Failure (TTF)|"Treatment failure was defined as an event which lead to the participant’s withdrawal from the study treatment due to lack of efficacy, disease progression, adverse events, or due to a participant's request as recorded in the Case Report Form (CRF), death, or use of other anticancer therapy.~TTF was assessed using Kaplan-Meier method, and the median TTF with 95% CIs was computed using the Brookmeyer and Crowley method."|Baseline to treatment failure (up to 24 months after the first treatment)|All participants registered to receive study treatment||Months||95% Confidence Interval|Median
153651|NCT00356122|Secondary|Objective Response Rate|"Objective response rate is the percentage of participants with an objective response. Improvements in tumor measurements from baseline values were assigned a status of Complete Response (CR) or Partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST). Overall objective response was the sum of CR and PR.~CR referred to the disappearance of all target lesions, and PR was at least 30% decrease in the sum of the longest diameter (LD) of target lesions, compared to the baseline sum LD. Responses were confirmed by repeat assessments within 4 to 6 weeks."|Baseline to CR or PR (up to 24 months after the first treatment)|All participants registered to receive study treatment||Percentage of participants||95% Confidence Interval|Mean
153652|NCT00356122|Primary|Progression-free Survival (PFS)|"PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first.~Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline to PFS (up to 24 months after the first treatment)|All participants registered to receive study treatment||Months||95% Confidence Interval|Median
153659|NCT00356057|Primary|Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months|Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))|Change from baseline to six months post-procedure|Patients included in this analysis are those patients with complete six minute walk test and Quality of Life data at both baseline and the six-month follow-up.||Percent Change||Standard Error|Mean
153660|NCT00355914|Primary|Oswestry Disability Index|Oswestry Disability Index 2.0 (ODI): ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).|Baseline, 3, 6, 12, 18, and 24 months post-treatment.|An intent-to-treat-analysis was performed on all patients utilizing the last follow-up data. Initial data were utilized in the patients who dropped out of the study without further follow-up after the first treatment.||units on a scale||Standard Deviation|Mean
153661|NCT00355914|Primary|Average Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|Baseline, 3, 6, 12, 18, and 24 months post-treatment|||units on a scale||Standard Error|Mean
153662|NCT00355797|Primary|Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)|Patients completing the orthostatic test in all three pacing modes and that had at least 80% pacing during the test in the CLS and R pacing modes are included in the analysis. The mean pulse pressure is provided.|within 45 days of enrollment|||mmHg||Standard Deviation|Mean
153663|NCT00355797|Secondary|Change in 6-minute Walk Test Distance|Change in number of 10 foot repetitions between baseline and 12-month visit were examined.|baseline and 12 months|Subjects completing the 6 minute walk at both enrollment and at the 12-month visit were included in intention to treat analysis.||repetitions||Standard Deviation|Mean
153664|NCT00355797|Secondary|Change in New York Heart Association (NYHA) Class|Number of subjects with improved, no change, or worsened NYHA classification at the 12-month visit, as compared to baseline. NYHA classifications (I to IV) are used to assess the various stages of heart failure, with Class I relating to mild heart failure and Class IV relating to severe heart failure.|baseline and 12 months|Subjects with NYHA classifications at both enrollment and at the 12-month visit were analyzed using intention to treat.||participants|||Number
153665|NCT00355797|Secondary|Cardiac Symptoms|Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.|12 months|All subjects answering questions about current cardiac symptoms at the 12-month visit were included in this intention to treat analysis.||participants|||Number
153666|NCT00355797|Secondary|Atrial Fibrillation (AF) Burden|AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.|12 months|Percentage of atrial burden was collected for subjects utilizing dual chamber pacing that completing a 12-month follow-up visit.||percentage of atrial beats||Standard Deviation|Mean
153667|NCT00355797|Secondary|Mode Reprogramming|Number of subjects with device reprogramming from dual (atrial and ventricular pacing) to single chamber (ventricular pacing only) or from single (ventricular pacing only) to dual chamber (atrial and ventricular pacing) during the 12 month follow-up.|12 months|Subjects completing at least one follow-up visit were analyzed using intention to treat.||participants|||Number
153668|NCT00355797|Secondary|Change in Quality of Life|Change in Quality of life (QOL) score was determined from baseline to the 12 month follow-up visit. The QOL utilized the physical functioning scale of the SF-36 v2, in which a higher score indicates a better health perception. Best possible score was 57.03 while the worst possible score was 14.94.|baseline and 12 months|Subjects completing a QOL at both baseline and 12 month follow-up were included in an intention to treat analysis.||score||Standard Deviation|Mean
153669|NCT00355797|Primary|Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)|Six-minute walk test and sweep test results for subjects completing tests in all three pacing modes and requiring at least 80% pacing during both tests in the CLS and R pacing modes. The mean composite of repetitions (six minute walk plus sweep) are presented.|within 45 days of enrollment|Patients requiring at least 80% pacing during both tests in the CLS and accelerometer pacing modes are included.||repetitions||Standard Deviation|Mean
153670|NCT00355784|Primary|Changes in Fat-free Mass||2 weeks|||kg||Standard Error|Mean
153671|NCT00355784|Primary|Changes in Fat Mass||2 weeks|||kg||Standard Error|Mean
153672|NCT00355784|Primary|2 Week Skeletal Muscle Protein Synthesis|after an overnight fast|2 weeks|per protocol||skeletal muscle protein%/hour||Standard Error|Mean
153673|NCT00355784|Primary|Whole Body Protein Turnover After 2 Week Intervention|whole body proteolytic rate (leucine Ra)|2 weeks|per protocol||µmol/kg fat free mass/min||Standard Error|Mean
153674|NCT00355784|Primary|Lipolytic Rate||2 weeks|per protocol||µmol/min||Standard Error|Mean
153675|NCT00355784|Primary|Baseline Skeletal Muscle Protein Synthesis|after an overnight fast|baseline|per protocol||skeletal muscle protein%/hour||Standard Error|Mean
153676|NCT00355784|Primary|Baseline Whole Body Protein Turnover|Whole body proteolytic rate (Leucine Ra)|baseline|per protocol||μmol/kg fat free mass/min)||Standard Error|Mean
153677|NCT00355784|Primary|Changes in Body Weight||2 weeks|per protocol||kg||Standard Error|Mean
153678|NCT00355784|Primary|24 Hour Average Plasma Growth Hormone Concentration||2 weeks|per protocol||ng/mL||Standard Error|Mean
153679|NCT00355706|Primary|Oswestry Disability Index|Oswestry Disability Index (ODI) – ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 (these patients are either bed-bound or exaggerating their symptoms).|24 months|||units on a scale||Standard Deviation|Mean
153680|NCT00355706|Other Pre-specified|Opioid Intake|Opioid intake(morphine equivalence mg)|24 months|||mg/day||Standard Deviation|Mean
153681|NCT00355706|Primary|Numeric Rating Scale|Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.|2 years|||units on a scale||Standard Deviation|Mean
153897|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153682|NCT00355615|Secondary|Percent Change in Non-HDL-C/HDL-C|Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
153683|NCT00355615|Secondary|Percent Change in TC/HDL-C|Percent change in the ratio of TC/HDL-C after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
153684|NCT00355615|Secondary|Percent Change in LDL-C/HDL-C|Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment|After 12 week of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
153685|NCT00355615|Secondary|Percent Change in ApoB/ApoA-1|Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
153686|NCT00355615|Secondary|Percent Change in Apolipoprotein B (ApoB)|Percent change in ApoB after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
153687|NCT00355615|Secondary|Percent Change in Apolipoprotein A-1 (ApoA-1)|Percent change in ApoA-1 after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||mean percent change||Standard Deviation|Mean
153688|NCT00355615|Secondary|Percent Change in Total Cholesterol (TC)|Percent change from baseline in total cholesteral after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
153689|NCT00355615|Secondary|Percent Change in Triglycerides (TG)|Percent change in tryglycerides (TG) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
153690|NCT00355615|Secondary|Percent Change in Non-HDL-C at 12 Weeks|Percent change in non-HDL-C at 12 weeks|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
153691|NCT00355615|Secondary|Percent Change in HDL-C|Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment|After 12 weeks of treatment|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percent change||Standard Deviation|Mean
153692|NCT00355615|Secondary|Percent Control Rate Based on Achievement of LDL-C Target of <110 mg/dL During Double-blind Dose Treatment|Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||Percent of Participants|||Number
153693|NCT00355615|Secondary|Percent Change in LDL-C and Other Lipid Parameters From Baseline to Week 6, and at End of Double-blind Dose Treatment Phase (Week 12)|Percent change from baseline in LDL-C after six week of treatment|6 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percentage||Standard Deviation|Mean
153694|NCT00355615|Primary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline (Day 0) to the End of the 12-week Double-blind Treatment Phase|Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100|12 weeks|Intention-to-treat (ITT) analysis set included all randomized patients who took study medication and had both a baseline reading and at least 1 post-baseline reading for the variable being analyzed. Analyses were performed using the last-observation-carried-forward (LOCF) method on the ITT analysis set for all efficacy outcome variables.||percentage||Standard Deviation|Mean
153898|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
153695|NCT00355472|Secondary|Time to Progression (TTP)|TTP was defined as the period from the day starting the first KW-0761 dosing to the day of PD identification (or the day of death if the subject died before PD was documented). Subjects were to be censored at the time of starting post-treatment, if it was started before PD identification.|Baseline to response|||days||Full Range|Median
153696|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).|t1/2||hours||Standard Deviation|Mean
153697|NCT00355472|Primary|Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)|The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.|0-7 days post final dose|AUC0-7 days||ng·h/mL||Standard Deviation|Mean
153698|NCT00355472|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.|0-7 days post final dose|||ng/mL||Standard Deviation|Mean
153699|NCT00355472|Secondary|Antitumor Effect|The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).|50 days|||participants|||Number
153700|NCT00355472|Primary|Maximum Tolerated Dose (MTD)|The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.|28 days|||mg/kg|||Number
153701|NCT00355472|Primary|Incidence of Dose-Limiting Toxicities (DLTs)|Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.|28 days|||participants|||Number
153702|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours|||NRS Score||Standard Deviation|Mean
153703|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours|||NRS Score||Standard Deviation|Median
153704|NCT00355394|Secondary|Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hours|All participants included.||NRS Score||Standard Deviation|Mean
153705|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at 24 Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|24 hours|||participants|||Number
153706|NCT00355394|Secondary|The Number of Subjects With a NRS Score of Zero at One Hour.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|1 hour|All participants included.||participants|||Number
153707|NCT00355394|Primary|The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.|The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.|2 hours|All participants included.||participants|||Number
153708|NCT00355368|Secondary|Number of Participants With an Failed First Intubation Attempts|defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt|within the first 90 sec following the start of induction|||participants|||Number
153709|NCT00355368|Secondary|Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.|"The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.~Units: measure on a scale"|during laryngoscopy and the first minute after completion of intubation|||score points||Standard Deviation|Mean
153710|NCT00355368|Secondary|Time to Completion of Intubation|time interval between the injection of the induction agent and the first appearance of endtidal CO2|time interval between the injection of the induction agent and the first appearance of endtidal CO2|||seconds||Standard Deviation|Mean
153711|NCT00355368|Secondary|Haemodynamic Sequelae of Intubation|any new haemodynamic alteration requiring immediate intervention|between start of induction sequence and 5 min after completion of intubation||||||
153712|NCT00355368|Primary|Number of Participants Exhibiting Desaturation >5%|decrease of >5% in oxygen saturation measured continuously using pulse oxymetry|at any time between the start of the intubation sequence and 2min after the completion of intubation|ITT||participants|||Number
153713|NCT00355147|Secondary|Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)~Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%."|Baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.||participants|||Number
153733|NCT00355121|Secondary|Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination|Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.||Titers||95% Confidence Interval|Geometric Mean
153714|NCT00355147|Secondary|Medication (Statins) for Secondary Stroke Prevention Risk Factor Management|"Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).~Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%."|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.||participants|||Number
153715|NCT00355147|Secondary|Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment|"Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data~Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)~Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%"|baseline, 6 months|We hypothesized the intervention group would report significantly greater medication compliance than the control group. The level of significance was set to 0.05. The number of participants were set per protocol and we used intention to treat in our protocol and analyses.||participants|||Number
153716|NCT00355147|Primary|Self-Efficacy to Manage Stroke Symptoms|Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.|6 months|We hypothesized the intervention group would report significantly greater self-efficacy to manage stroke symptoms than the control group. Level of significance was set to .05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, & time.||units on a scale||Standard Deviation|Mean
153717|NCT00355147|Primary|Stroke Specific Health Related Quality of Life|"Stroke Specifc, Health Related Quality of Life (SSQoL)~Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369.~Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores.~We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05."|6 months for (SSQoL) and 3 months for Perceived Energy Subdomain|We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05. Number of participants were set per protocol and we used intention to treat in our protocol and analyses. We adjusted the analyses for group, TIA/Stroke, site, and time.||units on a scale||Standard Deviation|Mean
153718|NCT00355134|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with non-missing data at each time point."||units on a scale||Standard Deviation|Mean
153719|NCT00355134|Secondary|Percentage of Participants Relapse-free up to End of Study|Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|From Baseline until the end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||percentage of participants||95% Confidence Interval|Number
153720|NCT00355134|Secondary|Percentage of Participants Relapse-free up to Month 24|Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.|24 months|Full analysis set||percentage of participants||95% Confidence Interval|Number
153721|NCT00355134|Secondary|Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||percentage of participants||95% Confidence Interval|Number
153734|NCT00355121|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1|Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).|Day 30 post-vaccination 1|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)||EU/mL||95% Confidence Interval|Geometric Mean
153722|NCT00355134|Secondary|Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study|Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan–Meier method.|24 months and end of study (up to approximately 54 months)|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||percentage of participants||95% Confidence Interval|Number
153723|NCT00355134|Secondary|Change From Baseline in Lesion Volume at Month 24 (Core Phase)|Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.|Baseline and Month 24|Full analysis set for whom data were available. N=the number of patients with non-missing baseline and post-baseline values.||mm^3||Standard Deviation|Mean
153724|NCT00355134|Secondary|Number of Gadolinium-enhanced T1 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. N indicates the number of participants with evaluable MRI data for the specified time point."||lesions||Standard Deviation|Mean
153725|NCT00355134|Secondary|Number of New or Newly Enlarged T2 Lesions|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.|From Baseline until Month 48|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with MRI data available for the specified time period."||lesions||Standard Deviation|Mean
153726|NCT00355134|Secondary|Percent Change From Baseline in Brain Volume|Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.|Baseline, Month 24 and end of study (up to approximately 54 months)|"Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. N indicates the number of participants with data available for the specified time period."||percent change||Standard Deviation|Mean
153727|NCT00355134|Secondary|Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.~A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).~ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|From Baseline until end of study (up to approximately 54 months).|Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.||relapses per year||95% Confidence Interval|Number
153728|NCT00355134|Primary|Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24|"ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.~A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).~ARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS)."|24 months|Full analysis set, including all patients who were randomized and took at least one dose of study drug.||relapses per year||95% Confidence Interval|Number
153729|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
153730|NCT00355121|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1|Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.||Participants|||Number
153731|NCT00355121|Other Pre-specified|Geometric Mean Titers Against Poliovirus After IPOL Vaccination.|Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.|Day 30 post-vaccination|Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2||Titers||95% Confidence Interval|Geometric Mean
153732|NCT00355121|Secondary|Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine|Fever was defined as a maximum oral temperature of ≥ 100.4ºF.|Day 0 through Day 7 post-vaccination at Visit 1|Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
156100|NCT00326183|Primary|Participants With 1 or More Serious Vaccine-Related Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.||participants|||Number
153735|NCT00355121|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.|Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)||Titers||95% Confidence Interval|Geometric Mean
153736|NCT00355121|Primary|Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination|Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.|Day 30 post-vaccination (Visit 1)|Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)||Participants|||Number
153737|NCT00355082|Secondary|The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)|Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.|Baseline and entire Continuation phase (24 Weeks)|All participants who entered the Continuation Phase||participants|||Number
153738|NCT00355082|Secondary|Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase|Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.|Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase|All participants who began the Continuation Phase||percent change in seizures||Full Range|Median
153739|NCT00355082|Secondary|Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase|The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn|The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators||participants|||Number
153740|NCT00355082|Secondary|Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)|Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.|Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators||percent change in seizures||Full Range|Median
153741|NCT00355082|Secondary|Percentage of Participants Meeting Escape Criteria in the Treatment Phase|The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.|Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators||percentage of participants|||Number
153742|NCT00355082|Secondary|Time to Discontinuation in the Treatment Phase|Time (days) until the participant discontinued the study|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug||Days||Standard Deviation|Mean
153743|NCT00355082|Secondary|The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)|All randomized participants in the 250 mg/day dose group who began withdrawal of background AED (Visit 5) minus any major protocol violators||percentage of participants|||Number
153744|NCT00355082|Primary|The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)|The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.|From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)|All randomized participants in the 300 mg/day dose group who began withdrawal of background antiepileptic drug (AED) (Visit 5) minus any major protocol violators||percentage of participants|||Number
153745|NCT00355030|Secondary|Bone Age|Bone age measured using the X-Ray of left hand and wrist.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.||years||Standard Deviation|Mean
153746|NCT00355030|Secondary|Percentage of Children With Normal Adult Height SDS|Percentage of children with normal adult height SDS (greater than -2 SDS and less than +2 SDS)|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.||percentage of participants|||Number
153777|NCT00354341|Secondary|Fractional Myocardial Shortening (FS)|FS was calculated as: ([LVEDD – LVESD] divided by LVEDV) multiplied by 100; where LVEDD = left ventricular end diastolic diameter (in centimeters [cm]), LVESD = left ventricular end systolic diameter (in cm), LVEDV = left ventricular end diastolic volume (in mL). FS is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here “n”= participants who were evaluable for each category, for respective arm groups.||percentage of LVEDV||Standard Deviation|Mean
153747|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline height for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.||standard deviation score||Standard Deviation|Mean
153748|NCT00355030|Secondary|Difference Between Adult Height SDS and Baseline Predicted Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of baseline predicted height [calculated using the Bayley-Pinneau method based on height and bone age] for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End up Study (up to 9 years)|All participants who received who reached final height.||standard deviation score||Standard Deviation|Mean
153749|NCT00355030|Secondary|Difference Between Adult Height SDS and Target Height SDS|"This is the difference between the gender, age and country matched standard deviation score of adult height and standard deviation score of target height [calculated as (mother’s height (SDS) + father’s height (SDS))/2] for particular participant.~The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height."|Baseline through End of Study (up to 9 years)|All participants who received who reached final height.||standard deviation score||Standard Deviation|Mean
153750|NCT00355030|Secondary|Height SDS|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual’s height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.||standard deviation score||Standard Deviation|Mean
153751|NCT00355030|Secondary|Height Velocity|Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit. The safety follow up participants did not reach final height at end of Period 1 unless final height is noted for participants that reached final height at the end of Period 1.||centimeter per year||Standard Deviation|Mean
153752|NCT00355030|Primary|Adult Height Standard Deviation Score (SDS)|The height of the participants were measured barefoot using a standard wall-mounted Harpenden stadiometer. SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug with at least one follow up visit.||standard deviation score||Standard Deviation|Mean
153753|NCT00355030|Primary|Number of Participants With One or More Drug-related Adverse Events|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline through End of Study (up to 9 years)|All participants who received at least one dose of study drug in Period 1 and all participants who entered Period 2 (safety population).||participants|||Number
153754|NCT00354978|Primary|Median Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.|From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months|Analysis per protocol.||Months||95% Confidence Interval|Median
153755|NCT00354913|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response). Per modified Macdonald criteria and assessed by MRI, complete response (CR) was the disappearance of all target lesions and partial response (PR) was a ≥50% decrease in the sum of the longest diameter of target lesions. Objective response = CR+PR.|69 Months|Intent-to-treat||percentage of participants|||Number
153756|NCT00354913|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of death from any cause, assessed up to 69 months.|Intent-to-treat||months||95% Confidence Interval|Median
153757|NCT00354913|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months.|Intent-to-treat||months||95% Confidence Interval|Median
153778|NCT00354341|Secondary|Left Ventricular End Diastolic Volume Index (LVEDVI)|LVEDVI was calculated by dividing left ventricular end diastolic volume (LVEDV) (in mL) BSA (in m^2). LVEDVI was presented in mL/m^2.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||mL/m^2||Standard Deviation|Mean
153758|NCT00354913|Primary|Progression-free Survival at 6 Months|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause.|From the date of study treatment initiation to the date of the first documented progression or death from any cause, whichever came first, assessed up to 69 months. For each participant, PFS was assessed at 6 months after treatment initiation.|Intent-to-treat||percentage of participants||95% Confidence Interval|Number
153759|NCT00354887|Primary|Number of Participants With Overall Response|Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.|Every 9 weeks from treatment initiation and confirmatory images 6 weeks or more after initial responses|Analysis was intent-to-treat; One patient developed an acute flare of Crohn’s disease after one cycle of study treatment and was removed from study without undergoing restaging scans.||participants|||Number
153760|NCT00354770|Primary|Massachusetts General Hospital Hairpulling Scale|There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data.|Baseline and final visit after 12 weeks|||units on a scale||Standard Deviation|Mean
153761|NCT00354744|Secondary|Toxicity|Assess immediate- and short-term toxicities of concurrent irinotecan hydrochloride and radiotherapy in these patients|2 years||||||
153762|NCT00354744|Secondary|Feasibility|Determine the feasibility of concurrent irinotecan hydrochloride and radiotherapy in these patients.|2 years||||||
153763|NCT00354744|Secondary|Early Disease Control|Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression therapy (comprising vincristine, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin) that permits maximal early exposure to known effective agents.|2 years||||||
153764|NCT00354744|Primary|Estimate of the Percent of Patients Event Free at 4 Years Following Study Entry|Event-free survival: Time to recurrence or death as a first event estimated from a Kaplan Meier curve.|4 years|All eligible patients||percent of participants||95% Confidence Interval|Number
153765|NCT00354744|Primary|Tumor Response Rate|Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the “measurable” mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as “non-measurable.” Complete Response (CR): Complete disappearance of the tumor confirmed at >4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning.|Protocol week 6 evaluation|All eligible patients with protocol week tumor assessment (N=102)||percent of participants|||Number
153766|NCT00354679|Primary|Evaluation of Safety and Toxicity|All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.|2 years|||participants|||Number
153767|NCT00354640|Secondary|Change in Serum Estradiol Levels|The change in serum concentrations of estradiol at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.||pmol/l||Full Range|Median
153768|NCT00354640|Primary|Change in Blood Concentrations|The change in blood concentrations of anastrozole at baseline and 14 days was measured.|Baseline and 14 days|Participants with blood samples for trough concentrations were included.||ng/ml||Full Range|Median
153769|NCT00354601|Primary|Objective Tumor Response|The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines|8 weeks|unable to measure due to failure to complete|||||
153770|NCT00354601|Secondary|Quality of Life|comparison of treatment end to pre entry and day 1 of each treatment cycle.|Pre-entry, day 1, treatment end|neither patient completed study|||||
153771|NCT00354601|Secondary|Number of Participants With Grade 3 or Higher Toxicity|summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)|tracked during incomplete treatment period||participants|||Number
153772|NCT00354601|Secondary|Time to Progression|Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter|Evaluated every 8 weeks during treatment|unable to analyze due to failure to complete treatment or study|||||
153773|NCT00354484|Primary|Reported Adverse Events||anytime between baseline and end of study or time to intervention||||||
153774|NCT00354484|Primary|Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL||anytime between baseline and end of study or time to intervention|||participants|||Number
153775|NCT00354341|Secondary|Percentage of Participants With Stable Hb Levels Between 13 to 15 g/dL||Week 26 up to Week 64|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||percentage of participants||95% Confidence Interval|Number
153776|NCT00354341|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was calculated as ([LVEDV - LVESV], divided by LVEDV) multiplied by 100; where LVEDV = left ventricular end diastolic volume (in mL), LVESV = left ventricular end systolic volume (in mL). LVEF is expressed in percentage of LVEDV.|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||percentage of LVEDV||Standard Deviation|Mean
153779|NCT00354341|Secondary|Left Ventricular End Systolic Volume Index (LVESVI)|LVESVI was calculated by dividing left ventricular end systolic volume (LVESV) (in milliliters [mL]) with body surface area (BSA) (in meter square [m^2]). LVESVI is presented in milliliter per meter square (mL/m^2).|Baseline, Months 6 and 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.||mL/m^2||Standard Deviation|Mean
153780|NCT00354341|Primary|Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15|LVMI (in g/m^2) = (0.8 [1.04 {(LVEDD + IVS + PWT)^3 – (LVEDD)^3}] + 0.6) divided by BSA. Here, LVEDD = left ventricular end diastolic diameter (in centimeters [cm]); PWT = left ventricular posterior wall thickness in diastole (in cm); IVS = interventricular septal wall thickness in diastole (in cm). Echocardiogram was performed at baseline and Month 15 to interpret LVMI which was expressed in grams per meter square (g/m^2).|Baseline, Month 15|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.||g/m^2||Standard Deviation|Mean
153781|NCT00354172|Secondary|Chimerism After Double Umbilical Cord Blood Transplant (UCBT)|Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient).|Day 21, Day 100, 6 Months|1 Year and 2 Year Post Transplant data was not applicable; no patients reached this timeframe to evaluate.||Percentage of Engrafted Cells||Full Range|Median
153782|NCT00354172|Secondary|Number of Participants (Patients) With Successful Natural Killer Cell Expansion|Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population|10-13 Days Post Infusion|||Participants|||Number
153783|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 24 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|2 Years Post transplant|||Participants|||Number
153784|NCT00354172|Secondary|Number of Participants (Patients) Who Experienced Relapse by 12 Months|Number of patients who experienced recurrence or progression of disease from the time of transplant.|1 Year Post Transplant|||Participants|||Number
153785|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 24 Months|Number of patients who died after receiving treatment within 24 months post transplant.|2 years post-transplant|||Participants|||Number
153786|NCT00354172|Secondary|Number of Participants (Patients) Who Died by 12 Months|Number of patients who died after receiving treatment within 12 months post transplant.|1 year Post Transplant|||Participants|||Number
153787|NCT00354172|Secondary|Number of Participants (Patients) With Chronic Graft-Versus-Host Disease|The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival.|Day 100 through 1 Year Post Transplant|||Participants|||Number
153788|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 post transplant|||Participants|||Number
153789|NCT00354172|Secondary|Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV|Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.|Day 100 Post Transplant|||Participants|||Number
153790|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Platelet Engraftment|Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days.|1 Year Post Transplant|||Participants|||Number
153791|NCT00354172|Secondary|Number of Participants (Patients) Who Attained Neutrophil Engraftment|"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)."|Day 42 Post Transplant|||Participants|||Number
153792|NCT00354172|Secondary|Number of Participants (Patients) Who Died Due to Transplant.|Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.|6 Months Post Transplant|||Participants|||Number
153793|NCT00354172|Secondary|Number of Patients Who Were Disease-free and Alive at 24 Months|Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.|24 Months Post transplant|||Participants|||Number
153794|NCT00354172|Secondary|Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months|Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.|12 Months Post transplant|||Participants|||Number
153795|NCT00354172|Primary|Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months|Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.|6 Months Post Transplant|One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.||Participants|||Number
153796|NCT00354159|Secondary|Characterize Arrhythmic Events|The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm|12 months post implant|All 399 subjects successfully implanted with the Chronicle ICD were included in the analysis.||VT/VF episodes per subject month||95% Confidence Interval|Number
153797|NCT00354159|Secondary|Characterize Quality of Life at Baseline and 12-month Visit|The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.|baseline to 12 months post implant|Subjects were required to respond to the baseline and 12-month follow-up visit to be included in the analysis.||scores on a scale||Standard Deviation|Mean
153798|NCT00354159|Secondary|Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)|The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin|Implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing.||percentage of subjects||95% Confidence Interval|Number
153799|NCT00354159|Secondary|Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)|Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.|implant|Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing as part of their ICD implant procedure.||Percentage of subjects with waveforms||95% Confidence Interval|Number
153800|NCT00354159|Secondary|Characterize Renal Function at the Baseline and 12-month Visit|Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.|baseline to 12 months post implant|Subjects were required to have creatinine values available at the baseline and 12-month visit to be included in the analysis of this objective.||mL/min/1.73 m^2||Standard Deviation|Mean
153801|NCT00354159|Secondary|Characterize Distance Walked in Six Minutes|The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.|baseline to 12 months post implant|Subjects were required to complete the 6-minute hall walk test at both the baseline and 12-month visit to be included in the analysis of this objective.||distance walked in 6-minutes (meters)||Standard Deviation|Mean
153802|NCT00354159|Secondary|Characterize NYHA Functional Class|The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.|baseline to 12 months post implant|Subjects were required to have an NYHA functional class assessment at the baseline and 12-month follow-up visit to be included in this analysis.||percentage of subjects|||Number
153803|NCT00354159|Secondary|Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.|12 months post implant|All Control Arm subjects with at least 90 days of pressure data available during the 12-month randomized follow-up period.||ePAD mm Hg||Standard Deviation|Mean
153804|NCT00354159|Secondary|Characterize Intracardiac Pressure|The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.|12 months post implant|At least 90 days of ePAD data were required for each subject during the 12-month randomized period to be included in the analysis.||ePAD mm Hg||Standard Deviation|Mean
153805|NCT00354159|Secondary|Characterize Medication Usage|The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.|12 months post implant|All randomized subjects.||Medication changes per subject month|||Number
153806|NCT00354159|Secondary|Characterize Subject Survival|Death from any cause during the 12-month randomization period|12 months post implant|All randomized subjects.||number of deaths|||Number
153807|NCT00354159|Secondary|Characterize Randomized Days Alive Out of Hospital|Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.|12 months post implant|All randomized subjects.||Days||Standard Deviation|Mean
153808|NCT00354159|Secondary|Characterize Health Resource Utilization|Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.|12 months post implant|All randomized subjects.||percentage of randomized days||Full Range|Mean
153809|NCT00354159|Secondary|Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.|"The definitions of worsened, improved, and unchanged are as follows:~Worsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF.~Improved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score.~Unchanged: Subject is neither worsened nor improved."|12 months post implant|All randomized follow-up from all randomized subjects were included.||Percent of Subjects|||Number
153810|NCT00354159|Secondary|Relative Risk of All-cause Events|All-cause events were defined as hospitalizations, hospitalizations <24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.|12 months post-implant|All randomized follow-up from all randomized subjects||All cause event rate per year||95% Confidence Interval|Mean
153812|NCT00354159|Secondary|Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group|The rate of CV-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized follow-up for all randomized subjects.||Cardiovascular related events per year||95% Confidence Interval|Mean
153813|NCT00354159|Secondary|Cumulative Days in the Hospital for Heart Failure|The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.|12 months post-implant|All follow-up from all randomized subjects were included in this analysis.||Percent days in hospital||Full Range|Median
153814|NCT00354159|Primary|Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group|The rate of HF-related events (hospitalizations >24h, hospitalizations <24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.|12 months post-implant|All randomized subjects||Heart failure related events per year||95% Confidence Interval|Mean
153815|NCT00354159|Primary|Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant|A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.|6 months post implant|All subjects with an attempted implant of the Chronicle IHM system were included in this analysis. At the time the study stopped, there was only one subject with an attempted Chronicle IHM implant. Thus this objective was not analyzed.||Percent of Chronicle IHM subjects||Full Range|Mean
153816|NCT00354159|Primary|Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.|A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.|Within 6 months post-implant|All 406 subjects with an attempted implant of the Chronicle ICD system.||Percentage of Chronicle ICD Subjects||95% Confidence Interval|Number
153817|NCT00354107|Secondary|Minimal Residual Disease by Using Southern Blotting or by Real-time Polymerase Chain Reaction (PCR)|NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|At baseline and weeks 5 and 11||||||
153818|NCT00354107|Secondary|Development of Human Antichimeric Antibodies by Using ELISA Method|Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.|Change from baseline to week 11||||||
153819|NCT00354107|Secondary|CD30 Concentrations Levels as Assessed by ELISA|Summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals. Although the limited sample size precludes formal hypothesis testing, exploratory analysis of the association between soluble CD30 levels and PK parameters and response will be performed.|At baseline||||||
153820|NCT00354107|Secondary|Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods||At baseline, at weeks 1, 2, 5, 6, and 11||||||
153821|NCT00354107|Primary|Response|Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive.|Week 4|||percent|||Number
153822|NCT00354029|Primary|NRS Pain = Numeric Rating Scale (0-10)|The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.|24 hours|||Units on a scale||Standard Deviation|Mean
153823|NCT00353977|Primary|Cellular Immune Response in Vaccine Recipients|Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating cytomegalovirus (CMV)-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors.|Day 45|11 subjects were CMV seropositive and 3 subjects were seronegative.||participants|||Number
153824|NCT00353795|Primary|Mean Coronary Wall Thickness|Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI).|n/a (cross sectional analysis)|||mm||Standard Deviation|Mean
153825|NCT00353704|Secondary|Morphine (Opioid) Consumption Cumulated|"Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as  cumulated opioid consumption (milligram)"|240 minutes|||mg||Standard Deviation|Mean
153826|NCT00353704|Primary|Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)|The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.|120 minutes after surgery|||Units on a scale||Standard Deviation|Mean
153827|NCT00353652|Secondary|Body Weight||Measured at 6 months||||||
153828|NCT00353652|Secondary|Electrolytes||Measured at 6 months||||||
153829|NCT00353652|Primary|Inflammatory Cytokines||Measured at 6 months||||||
153830|NCT00353652|Primary|C-reactive Protein||Measured at 6 months||||||
153831|NCT00353652|Primary|Baroreflex Sensitivity||Measured at 6 months||||||
153832|NCT00353652|Primary|Forearm Blood Flow||Measured at 6 months||||||
153833|NCT00353652|Primary|Insulin Sensitivity||Measured at 6 months||||||
153834|NCT00353652|Primary|24-hour Ambulatory Blood Pressure||Measured at 6 months||||||
153836|NCT00353496|Secondary|Percentage of Patients Still Alive Based on Available Overall Survival Data|Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study.|Randomisation to death or last visit, up to 321 weeks|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.||percentage of participants|||Number
153837|NCT00353496|Secondary|Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels||Week 12 to Week 96 (last visit)|Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis.||percentage of participants|||Number
153838|NCT00353496|Secondary|Change in the Global Health Status Quality of Life Assessment|Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life.|Week 12 to Week 96 (last visit)|Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid assessment.||score on a scale||Standard Error|Least Squares Mean
153839|NCT00353496|Secondary|Pharmacokinetic Profile of Lanreotide|Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints|Week 4, 12, 24, 36, 48, 72, 96|Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide||ng/mL||Standard Deviation|Mean
153840|NCT00353496|Secondary|Percentage of Patients Alive & Without Disease Progression|Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.|Week 48 & 96|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.||Percentage of participants|||Number
153841|NCT00353496|Primary|Progression-Free Survival (PFS)|Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0|From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year|Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects.||Weeks||95% Confidence Interval|Median
153842|NCT00353431|Secondary|Frequency of Hypokalaemia|Number of participants with hypokalaemia (potassium < 3.6 mmol/l, safety endpoint, expected to be similar in the two groups)|during observation of 48 hours|||participants|||Number
153843|NCT00353431|Secondary|Frequency of Severe Hypoglycaemia|Number of participants with severe hypoglycaemia (plasma glucose < 2.5 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours|||participants|||Number
153844|NCT00353431|Secondary|Frequency of Hypoglycemia|absolute number of participants with hypoglycemia (plasma glucose < 3.8 mmol/l) (safety endpoint, expected to be similar in the two groups)|during observation of 48 hours|||participants|||Number
153845|NCT00353431|Secondary|Time to Reach the Target Range|Hours needed to reach 5.5.-7.0 mmol/l (expected to be shorter in the intensive insulin group).|24 h|Intension to treat||hours||Standard Deviation|Mean
153846|NCT00353431|Primary|Time in the Glycaemic Target Range (5.5-7.0 mmol/l) During the Period of Observation of 48 Hours|Hours in which the plasma glucose was between 5.5 and 7.0 mmol/l (expected to be longer in the intensive insulin group)|48 h|Intension to treat||hours||Standard Deviation|Mean
153847|NCT00353418|Primary|Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia|Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.|Up to Week 72|The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.||Percentage of participants|||Number
153848|NCT00353418|Secondary|Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12|EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.|Week 12|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
153849|NCT00353418|Secondary|Rapid Virological Response (RVR) by Week 4|RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.|Week 4|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
153850|NCT00353418|Secondary|Relapse of Virological Response|Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.|Weeks 48 and 72|Within the All Patients Treated population, patients with a response at end of treatment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 37 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 83 patients.||Percentage of participants|||Number
153851|NCT00353418|Secondary|Virological Response at Weeks 4, 12 and 24|Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.|Weeks 4, 12 and 24|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
153852|NCT00353418|Secondary|Virological Response at End of Treatment Period|Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.|Week 48|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
153853|NCT00353418|Primary|Sustained Virological Response (SVR)|SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.|Week 72|The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.||Percentage of participants|||Number
153854|NCT00353366|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that : results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Throughout the study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Participants|||Number
153855|NCT00353366|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited Adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During 31 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Subjects|||Number
153856|NCT00353366|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhea, fever, irritability, loss of appetite and vomiting.|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort , which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Subjects|||Number
153857|NCT00353366|Primary|Number of Subjects Reporting Grade 2 or 3. Grade 2 : An AE Which Was Sufficiently Discomforting to Interfere With Normal Everyday Activities. Grade 3: an Unsolicited AE That Prevented Normal Everyday Activity.|Grade 2 or 3 assessed include fever, vomiting and diarrhea|During 15 days after each vaccine dose|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.||Subjects|||Number
153858|NCT00353301|Secondary|Overall Survival|For all subjects who had not died at the time of statistical analysis, duration of survival will was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the magnitude of the treatment effect as described for progression-free survival.|Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.||Weeks||95% Confidence Interval|Median
153859|NCT00353301|Primary|Progression-free Survival|Time to progression was defined as the time from beginning of therapy until disease progression or death. For subjects who had not progressed at the time of statistical analysis, progression-free survival was censored at the date of their last tumor assessment. Kaplan-Meier method was used to estimate median progression-free survival. Progression was defined as radiographic progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (year 2000 version), non-compliance in obtaining scans, unequivocal clinical progression or the initiation of another medication for the treatment of renal cell carcinoma.|Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks.|Per protocol analysis was used and 25 participants that were enrolled in the study were included in the analysis.||Weeks||95% Confidence Interval|Median
153860|NCT00353275|Secondary|Hypoglycemia||Duration of hospital stay||||||
153861|NCT00353275|Secondary|Organ Failure||Duration of hospital stay||||||
153862|NCT00353275|Primary|Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)||Duration of hospital stay||||||
153863|NCT00353275|Primary|Infectious Morbidity||Duration of hospital stay, an average of 2 weeks|The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.|||||
153864|NCT00353262|Secondary|Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities (hematology, coagulation, liver function, renal function, protein, electrolytes, miscellaneous).|Up to 28 days after last chemotherapy administration|All 36 participants who received at least one dose of capecitabine.||Participants|||Number
153865|NCT00353262|Secondary|Number Of Participants With Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. This includes any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during the study were also to be reported as AEs.|Approximately 3 Years (up to 28 days after the last intake of study medication)|All 36 participants who received at least one dose of capecitabine.||Participants|||Number
153899|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
153900|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Week 336|ITT Analysis Set, missing = excluded method|||||
153866|NCT00353262|Secondary|Clearance of Total And Free Platinum|CL is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (hour).|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||mL/Hr||Geometric Coefficient of Variation|Geometric Mean
153867|NCT00353262|Secondary|Volume of Distribution at Steady State (VSS) of Total And Free Platinum|VSS is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||mL||Geometric Coefficient of Variation|Geometric Mean
153868|NCT00353262|Secondary|T1/2 Beta of Total And Free Platinum|T1/2 beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of total and free platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||hour||Geometric Coefficient of Variation|Geometric Mean
153869|NCT00353262|Secondary|Cmax of Total And Free Platinum|Cmax is defined as maximum observed analyte concentration of Total And Free Platinum.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
153870|NCT00353262|Secondary|AUC0-last of Total And Free Platinum|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of Total And Free Platinum.|pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
153871|NCT00353262|Secondary|AUC0-infinity for Total Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (total platinum) in plasma over the time interval from 0 extrapolated to infinity.|Pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the two hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL* hr||Geometric Coefficient of Variation|Geometric Mean
153872|NCT00353262|Secondary|Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5’-DFUR , 5’-DFCR, 5 FU, and FBAL)|t1/2 Beta is the time measured for the plasma concentration to decrease by 1 half to its original concentration of capecitabine and its metabolites (5’-DFUR , 5’-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||hour||Geometric Coefficient of Variation|Geometric Mean
153873|NCT00353262|Secondary|Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Cmax is defined as maximum observed analyte concentration of capecitabine and its metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
153874|NCT00353262|Secondary|AUC0-last of Capecitabine and Its Metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL)|Area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration time point of capecitabine and its metabolites (5’-DFUR, 5’-DFCR, 5 FU, and FBAL).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
153875|NCT00353262|Secondary|AUC (0-infinity) of Capecitabine and Its Metabolites (5’-DFCR, 5-FU, and FBAL)|AUC0-infinity represents the area under the concentration-time curve of the analytes (5’-DFCR, 5-FU, and FBAL) in plasma over the time interval from 0 extrapolated to infinity. After oral administration, capecitabine is first metabolized in the liver to 5’-deoxy-5-fluorocytidine (5’-DFCR), which is then converted to 5’-DFUR, and then catalytically activated to 5-FU.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
153901|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288||Week 288|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153902|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240||Week 240|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153903|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192||Week 192|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153876|NCT00353262|Primary|AUC0-inf for Free Platinum|AUC0-infinity represents the area under the concentration-time curve of the analyte (free platinum) in plasma over the time interval from 0 extrapolated to infinity. AUC0-inf for free platinum was calculated for each participant from the concentration-data obtained on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3. Free platinum is not bound to plasma proteins and is considered to be the most clinically significant measure of pharmacological and toxicological activity.|Predose , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours from the beginning of the 2 hour oxaliplatin infusion on Days 2 to 5 of Cycle 1, and Days 1 to 4 for Cycle 2 and 3.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL * hr||Geometric Coefficient of Variation|Geometric Mean
153877|NCT00353262|Primary|Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0–Inf) of 5’-Deoxy-5-fluorouridine 5’-(DFUR)|AUC0-infinity represents the area under the concentration-time curve of the analyte (5’-DFUR) in plasma over the time interval from 0 extrapolated to infinity. The analyte 5’-DFUR, the direct precursor of 5-fluorouracil (5-FU), is considered to be the most important metabolite of capecitabine in plasma. The unit of measure was nanograms per millilitre per hour (ng/mL * hr).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post the dose.|All patients for whom observations contributing to the relevant assessments were available, who did not experience dose reductions, and for whom dosing was as required by the protocol were included in the corresponding analysis.||ng/mL*hr||Geometric Coefficient of Variation|Geometric Mean
153878|NCT00352118|Secondary|Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
153879|NCT00352118|Secondary|Swallowing Ability - Quality of Life Scores|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).|Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
153880|NCT00352118|Secondary|Time to Treatment Failure|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.|Number of Days from Complete or Partial Response to First Date of Recurrence or Progression|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
153881|NCT00352118|Secondary|Number of Days With Disease Free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.|From Date of Registration to Date of First Treatment Failure or Death|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
153882|NCT00352118|Secondary|Number of Days - Overall Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of death.|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
153883|NCT00352118|Secondary|Number of Days With Progression-free Survival|All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.|Between date of registration to date of first treatment failure or death.|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
153884|NCT00352118|Primary|Number of Patients With Feeding Tube Dependency|All patients were non-evaluable and study was terminated early. There is no measure of outcome.|at 12 months|All patients were non-evaluable - did not receive radiation dose per protocol.|||||
153885|NCT00352105|Primary|Number of Participants With No Distant Metastatic Disease at 1 Year|1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.|1 year|5 early deaths were not evaluable||participants|||Number
153886|NCT00352105|Secondary|Number of Participants Who Completed 2 Years of Therapy||at 2 years after start of treatment|||participants|||Number
153887|NCT00352105|Secondary|Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.|Complete response rate per RECIST Criteria (CTC V3)|3 years|5 early deaths were not evaluable||participants|||Number
153888|NCT00352105|Secondary|Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity|Any toxicity greater than or equal to Grade 1= mild|at 1 year after start of treatment|||participants|||Number
153889|NCT00352105|Secondary|Number of Participants With No Local Disease at 1 Year|Number of Participants with No Local Disease at 1 Year. Local disease means that the cancer came back in the same site.|at 1 year after start of treatment|5 early deaths not evaluable||participants|||Number
153890|NCT00352105|Primary|Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival|To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival|at 1 year after start of treatment|||participants|||Number
153891|NCT00352053|Secondary|Percentage of Participants With Virologic Failure Through Week 48|"Virologic failure was defined as either nonresponse or viral rebound.~Nonresponse (failure to achieve response). Response was defined as either~A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or~HIV-1 RNA < 400 copies/mL at 2 consecutive visits.~Viral rebound was defined as either~Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or~Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.~The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase."|Up to 48 weeks|ITT Analysis Set. 1 participant without time to respond [6 days of treatment]) was excluded. Nonresponders were counted as failures at time 0. Rebounders were counted as failures on study day of the first of 2 assessments meeting criteria. Otherwise, they were censored at last double-blind HIV measurement.||Kaplan-Meier percentage|||Number
153906|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48||Week 48|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
153907|NCT00352053|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24||Week 24|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
153908|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 336|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
153909|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153910|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153911|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153912|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153913|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||Percentage of participants|||Number
153914|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
153915|NCT00352053|Secondary|Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.||Percentage of participants|||Number
153916|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Percentage|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
153917|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
153918|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
153919|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
153920|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
153921|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
153922|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 48 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
153923|NCT00352053|Secondary|Change From Baseline to Week 24 in CD4 Percentage|CD4 percentage is the percentage of total lymphocytes that are CD4 cells.|Baseline to 24 weeks|ITT Analysis Set, missing = excluded method||Percentage of CD4 lymphocytes||Inter-Quartile Range|Median
153924|NCT00352053|Secondary|Change From Baseline to Week 336 in CD4 Count|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
153925|NCT00352053|Secondary|Change From Baseline to Week 288 in CD4 Count||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
153926|NCT00352053|Secondary|Change From Baseline to Week 240 in CD4 Count||Baseline to 240 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
153927|NCT00352053|Secondary|Change From Baseline to Week 192 in CD4 Count||Baseline to 192 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
153928|NCT00352053|Secondary|Change From Baseline to Week 144 in CD4 Count||Baseline to 144 weeks|ITT Analysis Set, missing = excluded method||cells/mm^3||Inter-Quartile Range|Median
153929|NCT00352053|Secondary|Change From Baseline to Week 96 in CD4 Count||Baseline to 96 weeks|ITT Analysis Set, missing = excluded method||cells/mm3||Inter-Quartile Range|Median
153930|NCT00352053|Secondary|Change From Baseline to Week 48 in CD4 Count||Baseline to 48 weeks|ITT Analysis Set, missing = excluded method||cells/mm3||Inter-Quartile Range|Median
153931|NCT00352053|Secondary|Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count||Baseline to 24 weeks|ITT Analysis Set, missing = excluded method||cells/mm3||Inter-Quartile Range|Median
153932|NCT00352053|Secondary|Change From Baseline to Week 336 in HIV-1 RNA|No analysis was performed because the last study participant discontinued after Week 294 and the study was closed.|Baseline to 336 weeks|ITT Analysis Set, missing = excluded method|||||
153933|NCT00352053|Secondary|Change From Baseline to Week 288 in HIV-1 RNA||Baseline to 288 weeks|ITT Analysis Set, missing = excluded method||log10 copies/mL||Inter-Quartile Range|Median
153938|NCT00352053|Secondary|Change From Baseline to Week 48 in HIV-1 RNA||Baseline to 48 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the LOCF method. The Placebo/TDF groups were analyzed using the missing = excluded method.||log10 copies/mL||Inter-Quartile Range|Median
153939|NCT00352053|Secondary|Change From Baseline to Week 24 in HIV-1 RNA||Baseline to 24 weeks|ITT Analysis Set. The Tenofovir DF and Placebo groups were analyzed using the last observation carried forward (LOCF) method (includes the participant’s last available postbaseline value for missing data). The Placebo/TDF groups were analyzed using the missing = excluded method (participants with missing data were excluded from the analysis).||log10 copies/mL||Inter-Quartile Range|Median
153940|NCT00352053|Secondary|Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA|"DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed)."|Baseline to 48 weeks|ITT Analysis Set||log10 copies/mL||Inter-Quartile Range|Median
153941|NCT00352053|Primary|Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA|"DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed)."|Baseline to 24 Weeks|Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least 1 dose of study drug, with baseline HIV-1 RNA ≥ 1000 copies/mL and who had no major eligibility criteria violations.||log10 copies/mL||Inter-Quartile Range|Median
153942|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Stage|Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage <III showed a better outcome but was not statistically significant.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up|||events|||Number
153943|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Histology|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up|||events|||Number
153944|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Gender|Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance.|3 years follow-up|||events|||Number
153945|NCT00352027|Secondary|Toxicities With Grade >1|Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years|Toxicities reported below for the current study (HOD05) include all reported toxicities from a participant's on-study date through 2/17/2016. Toxicities reported below for the HOD99 study include all those reported from a participant's on-study date through their off-study date.||adverse events|||Number
153946|NCT00352027|Secondary|3-year Local Failure-free Survival Probability|Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years|||probability||95% Confidence Interval|Number
153947|NCT00352027|Secondary|3-year Overall Survival (OS) Probability|Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3-years|||probability||95% Confidence Interval|Number
153948|NCT00352027|Secondary|3-year Event-free Survival (EFS) Probability|Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99.|3 years|||probability||95% Confidence Interval|Number
153949|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153989|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153950|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153951|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153952|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153953|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153954|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153955|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153956|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
154024|NCT00352885|Secondary|Immune System Functioning||Measured over 5 months of IL-2 treatment||||||
154025|NCT00352885|Secondary|Neuroendocrine System Functioning and Stress Hormone Levels||Measured over 5 months of IL-2 treatment||||||
154026|NCT00352885|Primary|Number of IL-2 Treatments Tolerated||Measured over 5 months of treatment|||one IL-2 injection of 720,000 units/kg||Standard Deviation|Mean
153957|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score|"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153958|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153959|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153960|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153961|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153962|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153963|NCT00352027|Secondary|Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score|"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|6 months after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant completed the QoL and symptom distress questions.||beta coefficient||95% Confidence Interval|Number
153978|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153964|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153965|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153966|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153967|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153968|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153969|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153970|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154033|NCT00352755|Secondary|Progression Rate|-Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Median follow-up was 32 months|||percentage of participants|||Number
153971|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153972|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153973|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153974|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153975|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153976|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153977|NCT00352027|Secondary|Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning|"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153979|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153980|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153981|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153982|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153983|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153984|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153985|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153986|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153987|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153988|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154034|NCT00352755|Primary|Safety and Tolerability of the Planned Treatment Regimen as Measured by Number of Participants With Grade 3 or Higher Adverse Events||30 days after end of treatment|||participants|||Number
154035|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Pneumonitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0.||participants|||Number
153990|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153991|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153992|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153993|NCT00352027|Secondary|Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score|Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153994|NCT00352027|Secondary|Patient Quality of Life (QoL), Symptom Distress Scale|"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153995|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Communication|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153996|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153997|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
153998|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Worry|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154027|NCT00352846|Primary|Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months|The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score >= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores <= -2.5 indicate osteoporosis.|From baseline to 12 Months|BMD data available on 53 evaluable participants upon treatment completion.||Percentage Change of BMD||Standard Deviation|Mean
153999|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154000|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154001|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Nausea|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154002|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154003|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.3.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100."|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Pre-therapy data for PedsQL v.3.0 (symptoms) was not collected, because participants had not started chemotherapy. Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154004|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154005|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154006|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154007|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154028|NCT00352781|Secondary|Smoking Cessation|7-day point prevalence of abstinence|12 months after end of treatment|Number of participants who completed the 12m follow-up||percentage of participants abstinent|||Number
154029|NCT00352781|Primary|Smoking Cessation|7-day point prevalence of abstinence|6 months after end of treatment|Number of participants that completed the 6m follow-up (i.e. per protocol)||percentage of participants abstinent|||Number
154030|NCT00352755|Secondary|Overall Survival||Median follow-up was 32 months|||months||Full Range|Median
154008|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154009|NCT00352027|Secondary|Patient Quality of Life (QoL), PedsQL v.4.0: Total Score|"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100."|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy|Each institution made the decision whether to complete the QoL objective. For each time point, a participant and parent proxy completed the QoL questions. Adult participants of majority age did not have a parent proxy.||units on a scale||Standard Deviation|Mean
154010|NCT00352027|Secondary|Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy||1, 2, 5, and 10 years post therapy||||||
154011|NCT00352027|Secondary|Prognostic Factors for Treatment Failure: Age|Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance.|5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up|||events|||Number
154012|NCT00352027|Secondary|Local and Distant Failure for Children Treated With Tailored-field Radiation|The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field.|from first enrollment date up to 3 years follow-up|||probability that the event occurs||95% Confidence Interval|Number
154013|NCT00352027|Secondary|Disease Failure Rate Within Radiation Fields|Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).|3 years|||proportion of participants||95% Confidence Interval|Number
154014|NCT00352027|Primary|3-year Event-Free Survival Probability|The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame.|3 years|||probability||95% Confidence Interval|Number
154015|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Percentage change||Standard Deviation|Mean
154016|NCT00353119|Secondary|Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI)|"Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|24 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Percentage change||Standard Deviation|Mean
154017|NCT00353119|Secondary|Number of Adverse Events|Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment.|28 weeks|Patients that crossed over from placebo to etanercept are included in the Etanercept group. The placebo group only included adverse events from the first 12 weeks prior to the crossover. The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Adverse Events|||Number
154018|NCT00353119|Primary|Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover|"Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 12 weeks in patients treated with placebo or etanercept~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).~Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible)."|12 weeks|The intent to treat (ITT) population is the same as the per protocol (PP) population. There was no imputation technique necessary.||Percentage change||Standard Deviation|Mean
154019|NCT00352911|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 56|Mean log change in HIV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.|Baseline (Day 1) to Day 56|||copies/mL on log scale||Standard Deviation|Log Mean
154020|NCT00352885|Secondary|Genetic Polymorphisms||Measured before and after IL-2 treatment||||||
154021|NCT00352885|Secondary|Cognitive Functioning, as Assessed by Computerized Neuropsychological Testing||Measured on Day 2 of each IL-2 cycle||||||
154022|NCT00352885|Secondary|Serotonin Metabolism||Measured over 5 months of IL-2 treatment||||||
154023|NCT00352885|Secondary|Serotonin Metabolism||Measured over 5 months of IL-2 treatment||||||
154036|NCT00352690|Primary|Overall Survival (OS)|OS = time from patient registration to death of all causes|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown expiration dates were censored at the date of last clinical contact.||months||95% Confidence Interval|Median
154037|NCT00352690|Secondary|Incidence and Severity of Radiation-induced Esophagitis||30 days following completion of treatment (approximately 114 days)|Using CTCAE Version 3.0||participants|||Number
154038|NCT00352690|Secondary|Response Rates|Overall best response using RECIST 1.0|4 years|||participants|||Number
154039|NCT00352690|Secondary|Failure-free Survival (FFS)|The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)|Completion of follow-up (follow-up ranged from 3 months to 6 years)|Participants with unknown event dates were censored at the date of last clinical contact.||months||95% Confidence Interval|Median
154040|NCT00352690|Secondary|Failure-free Survival (FFS) Rate|"The time between patient registration and a failure event (progression, relapse, or death of all cause, whichever is first)~Estimated using Kaplan Meier"|6 months|Participants with unknown event dates were censored at the date of last clinical contact.||percentage of participants|||Number
154041|NCT00352690|Primary|Overall Survival (OS) Rate|"OS = time from patient registration to death of all causes~Estimated using Kaplan Meier"|6 months|Participants with unknown expiration dates were censored at the date of last clinical contact.||percentage of participants|||Number
154042|NCT00352664|Primary|Sedation Mean Scores at 1-Week|Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing “not drowsy” and 10 representing “worst possible drowsiness.”|Baseline and Day 7|Analysis was intention to treat (ITT), and population analyzed was that treated. Study closed early due to low patient accrual and insufficient supply of drug. No patients were randomized to Placebo Arm.||Scores on a Scale||Standard Deviation|Mean
154043|NCT00352612|Primary|Clinical Improvement at the 48-72 Hour Clinical Follow-up|Clinical improvement was defined as improvement in at least one of the following four measures without regression in any: (1) erythema (2) pain (3) induration (4) patient or families self report of improvement.|48-72 hour clinical follow-up|||participants|||Number
154044|NCT00352417|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)||Baseline and 12 weeks|Evaluable population with both baseline and visit 8 results||mg/L||95% Confidence Interval|Least Squares Mean
154045|NCT00352417|Secondary|Change From Baseline in Urine Leukotriene E4 Adjusted for Creatinine||Baseline and 12 Weeks|Evaluable Population||Percent Change||95% Confidence Interval|Geometric Mean
154046|NCT00352417|Secondary|Change From Baseline in Whole Blood Leukotriene B4 Production||Baseline and 12 weeks|Evaluable Population||pg/ml||95% Confidence Interval|Least Squares Mean
154047|NCT00352417|Secondary|Percent Cross-sectional Area of Anti-5-Lipoxygenase Staining in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of anti-5-Lipoxygenase staining in plaque tissue|12 weeks|Evaluable Population with histological sections available||Percent Area||95% Confidence Interval|Mean
154048|NCT00352417|Primary|Percent Cross-sectional Area of Macrophages in Plaque Tissue|Effect of VIA-2291 100-mg relative to placebo after 12 weeks of daily dosing on the percent cross-sectional area of macrophages in plaque tissue using an anti-CD68 antibody|12 weeks|Evaluable Population with histological sections available||Percent Area||95% Confidence Interval|Mean
154049|NCT00352365|Primary|Complete Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl.|Up to 5 years|Eligible patients who began protocol therapy||percentage of participants||95% Confidence Interval|Number
154050|NCT00352365|Secondary|Total Response|Morphologic complete remission (CR): ANC >=1,000/mcl, platelet count >=100,000/mcl, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Partial remission (PR): ANC >1,000/mcl, platelet count >100,000/mcl, and at least 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts <5% with persistent Auer rods.|Up to 5 years|Eligible patients who began protocol therapy||percentage of participants||95% Confidence Interval|Number
154051|NCT00352365|Secondary|Cytogenetic Abnormalities|Number of baseline cytogenetic abnormalities by responders (CR, CRi, and PR) and nonresponders.|Up to 5 years|||Number of abnormalities||Full Range|Median
154052|NCT00352365|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
154053|NCT00351936|Primary|Change From Baseline in Triglycerides|Evaluating change in triglyceride levels between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
154054|NCT00351936|Primary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Evaluating change in high-density lipoprotein cholesterol (HDL-C) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
154055|NCT00351936|Primary|Change From Baseline in Low-density Lipoprotein (LDL)|Evaluating change in low-density lipoprotein (LDL) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
154056|NCT00351936|Primary|Change From Baseline in Fasting Total Cholesterol|Evaluating change in fasting total cholesterol between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||mg/dL||Standard Deviation|Mean
154057|NCT00351936|Primary|Change From Baseline in Waist-hip Ratio (WHR)|Evaluating change in waist-hip ratio (WHR) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||cm||Standard Deviation|Mean
154058|NCT00351936|Primary|Change From Baseline in Body Mass Index (BMI)|Evaluating change in Body Mass Index (BMI) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||kg/m^2||Standard Deviation|Mean
154059|NCT00351936|Primary|Change From Baseline in Weight (Lbs)|Evaluating change in weight (lbs) between Baseline and Week 4, comparing subjects treated with aripiprazole for 4 weeks to subjects treated with placebo for 4 weeks.|baseline, week 4|||lbs||Standard Deviation|Mean
154060|NCT00351741|Secondary|Ventilator Associated Tracheobronchitis (VATB)|Defined as carinal or mainstem airway friability and sloughing with associated bleeding. Only diagnosed after the patient had spent at least 7 days on the assigned ventilator mode and had not been diagnosed with inhalation injury on admission|checked daily|||Participants|||Number
154061|NCT00351741|Secondary|Barotrauma|Defined as a new pneumothorax, pneumomediastinum, subcutaneous emphysema, interstitial emphysema, or pneumatocele >2 cm in diameter not associated with a vascular procedure, lung biopsy, or thoracentesis.|28 days|||Participants|||Number
154062|NCT00351741|Secondary|Need for Rescue Ventilator|Subjects who did not meet predetermined oxygenation and ventilation goals on the study mode despite ventilator- specific optimization were switched to a rescue mode of ventilation.|28 days|||Participants|||Number
154063|NCT00351741|Secondary|Ventilator Associated Pneumonia|Those who develop both clinical and microscopic evidence of pulmonary infection while on the ventilator.|28 days|||Participants|||Number
154064|NCT00351741|Secondary|Death|In-hospital death.|during hospitalization|||Participants|||Number
154065|NCT00351741|Secondary|Days Free From Nonpulmonary Organ Failure|days free from nonpulmonary organ failure as adapted from the ARDSnet study in the first 28 days.|28|||Days||Standard Deviation|Mean
154066|NCT00351741|Primary|Ventilator-free Days During the First 28 Days|The primary end point was ventilator-free days in the first 28 days, defined as the number of days after randomization from day 0 to day 28 alive without ventilator assistance for at least 48 consecutive hrs.|28 days|||Days||Standard Deviation|Mean
154067|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154068|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154069|NCT00351533|Secondary|Change in Plasma Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154070|NCT00351533|Secondary|Change in Plasma Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154071|NCT00351533|Secondary|Change in Plasma Interleukin-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154072|NCT00351533|Secondary|Change in BALF Neutrophil Count|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||# of cells/mm^3||Inter-Quartile Range|Median
154073|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154074|NCT00351533|Secondary|Change in BALF Interleukin-6|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154075|NCT00351533|Secondary|Change in BALF Leukotriene B4|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154076|NCT00351533|Secondary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 9|||pg/mL||Inter-Quartile Range|Median
154077|NCT00351533|Secondary|60-day Mortality||60 days from day of enrollment into study|||Participants|||Number
154078|NCT00351533|Secondary|Hospital Mortality||At end of hospitalization|||Participants|||Number
154079|NCT00351533|Secondary|Hospital Length of Stay||At end of hospital admission|||Days||Standard Deviation|Mean
154080|NCT00351533|Secondary|ICU-free Days During First 28 Days After Study Enrollment|ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.|28 days|||Days||Standard Deviation|Mean
154081|NCT00351533|Secondary|Ventilator-free Days During First 28 Days After Study Enrollment|Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.|28 days|||Days||Standard Deviation|Mean
154082|NCT00351533|Secondary|Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment|"Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients.~Minimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs."|Throughout hospital stay|||Scores on a scale||Standard Deviation|Mean
154083|NCT00351533|Secondary|Change in Plasma vonWillebrand Factor|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154084|NCT00351533|Secondary|Change in Plasma Surfactant Protein D|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154085|NCT00351533|Secondary|Change in Plasma Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154086|NCT00351533|Secondary|Change in Plasma Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154087|NCT00351533|Secondary|Change in Plasma Interleukin-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154088|NCT00351533|Secondary|Oxygenation|PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5|||PaO2/FiO2||Standard Deviation|Mean
154089|NCT00351533|Secondary|Static Lung Compliance|30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.|Day 5|||L/cm H20||Standard Deviation|Mean
154090|NCT00351533|Secondary|Change in BALF Neutrophil Count|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||# of cells/mm^3||Inter-Quartile Range|Median
154091|NCT00351533|Secondary|Change in BALF Monocyte Chemotactic Protein-1|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154092|NCT00351533|Secondary|Change in BALF Interleukin-6|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154093|NCT00351533|Secondary|Change in BALF Leukotriene B4|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|||pg/mL||Inter-Quartile Range|Median
154094|NCT00351533|Primary|Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8|30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.|Days 1 and 5|The primary outcome was >=50% reduction in BALF IL-8, measured as the change from baseline to day 5. With α=0.05 and β=0.2, we calculated that 26 patients per group were needed if participants underwent two BALs. Analysis was intention to treat (ITT).||pg/mL||Inter-Quartile Range|Median
154095|NCT00351377|Secondary|Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient|"Assessed using the Overall Treatment Effects for health-related quality of life questionnaire. Possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.||Participants|||Number
154096|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Patient|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the patient."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.||Participants|||Number
154097|NCT00351377|Secondary|Overall Treatment Effects for GI Symptoms Assessed by the Physician|"Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms. The possible answers were: Improved, about the same, or worse. The questionnaire was completed by the physician."|6-8 week|Intention to treat population consisting of all enrolled participants who received study medication.||Participants|||Number
154098|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The change from baseline to the 6-8 week visit for each of the six subscores (each ranging from 0-5) of the PGWB were analyzed individually. Each of the subscores was transformed to fit a range from 0-100. Lower scores indicate more unfavorable conditions, so an increase in score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
154099|NCT00351377|Secondary|Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium|The PGWB consists of 22 single items (each ranging from 0-5) with 7 dimensions (including the total score) to be calculated. Lower scores indicate more unfavorable conditions. The total raw score is calculated by summing up all of the single items and thus has a hypothetical range from 0-110 score points. This raw score is further transformed using the formula: (raw score / 110) x 100 to fit a range from 0-100.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
154100|NCT00351377|Secondary|Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium|The 5 different subscales of the GI-related Quality of Life (GIQLI) were analyzed separately by calculating the average value of the items that were included in the respective subscore. Thus, the theoretical range for each of the subscores was the same as for the single items, i.e. 0-4 score points. An increase in the subscale score indicates an improvement in symptoms.|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
154101|NCT00351377|Secondary|Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium|Assessed by changes in the Gastrointestinal Quality of Life Index (GIQLI) from Baseline visit to the 6-8 week visit. The GIQLI is a 36-item questionnaire and consists of 5 different subscales. The total score was calculated as the sum of the 36 single items which each ranged from 0-4, leading to a hypothetical range from 0-144 score points (lower scores indicate more unfavorable conditions). The mean change was calculated as (6-8 week visit value) minus (Baseline value).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
154102|NCT00351377|Secondary|Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium|Changes in GI symptom severity was measured by changes in the total scores of 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit to the visit at 6-8 weeks. The GSRS is a 15-item instrument with a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).|Baseline and 6-8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
154103|NCT00351377|Primary|Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)|Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.|Baseline and 6 - 8 weeks|Intention to treat (ITT) population consisting of all enrolled participants who received study medication.||Scores on a scale||Standard Deviation|Mean
154104|NCT00351351|Primary|Kidney Stone Clearance Rate|stone clearance rate calculated in mm^2/min per protocol specification|6 months|Sample size calculations were performed using a two-sided Student’s t-test with a power of 90% and a significance level of  = 0.05.||mm^2/min||Full Range|Mean
154105|NCT00351273|Secondary|Number of Patients With a Complete Response (Resolution of All Symptoms)||Months 1, 3, 6 and 9||||||
154106|NCT00351273|Secondary|Health Assessment Questionnaire (HAQ)||Months 6 and 9||||||
154107|NCT00351273|Secondary|Enthesitis (Presence or Absence of Plantar Fasciitis or Achilles Tendonitis)||Months 6 and 9||||||
154108|NCT00351273|Secondary|Dactylitis||Months 6 and 9||||||
154109|NCT00351273|Secondary|Disease Activity Score 44 (DAS44): Ritchie Articular Index (Tender Joint Count), Swollen Joint Count (Out of 44 Joints), ESR, Patient Global Assessment (Visual Analog Scale)||Months 6 and 9||||||
154110|NCT00351273|Secondary|Psoriatic Arthritis Response Criteria (PsARC): Swollen Joint Count, Tender Joint Count, Physician and Patient Global Assessment||Months 6 and 9||||||
154111|NCT00351273|Secondary|Comparison of Erythrocyte Sedimentation Rate (ESR) and C-reactive Protein (CRP)||Month 6||||||
154112|NCT00351273|Secondary|"Individual Comparison of 6 Responder Criteria in the Combination Antimicrobial Groups Versus the Placebo Group"||Months 6 and 9||||||
154113|NCT00351273|Primary|Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment.|The outcome measure was a composite endpoint. Participants had to meet 4/6 clinical criteria. 17/24 subjects randomized to combination antibiotics did respond to treatment when compared to 3/10 randomized to placebo.|Month 6|Efficacy and safety analyses were performed on an intent to treat(ITT) basis. Subjects who prematurely withdrew or who were lose to follow up for any reason were included in the ITT population and were considered nonresponders.||participants|||Number
154114|NCT00351039|Secondary|Overall Survival (Median Survival [MS])|Secondary Objective: Determine the Overall Survival (median survival[MS]) in patients with advanced NSCLC treated with this regimen. Patients were to be followed until death and survival curves were to be generated.|26 Months|Had the study been completed as planned we would have measured Overall Survival described as Median Survival. This study was closed early due to poor accrual.||Months||95% Confidence Interval|Median
154115|NCT00351039|Primary|Progression Free Survival (PFS)|The primary objective was to determine the progression free survival (PFS), in newly diagnosed patients with advanced Non Small Cell Lung Cancer (NSCLC) who are treated with a regimen consisting of Bevacizumab(B), pemetrexed(A), and erlotnib(T). This was a Phase I/II study. This trial was halted after the Phase I component was completed. The Phase II component was never initiated.|26 months|No patients proceeded to Phase II for evaluation.||Months||95% Confidence Interval|Median
154116|NCT00351039|Secondary|Number of Participants With Grade 3 and Grade 4 Adverse Events|By Safety, the intent was to capture, tabulate, list all of the grade 3 and 4 adverse effects seen by this protocol. For each toxicity, we followed the Common Toxicity Criteria(NCI CTC)Version 2.0 Toxicity scale guidelines.|26 Months|This study was initially intended to be a Phase I/II study with a brief Phase I Run-in. After the brief Phase I Run-in the study was closed without initiating the Phase II component.||Participants|||Number
154377|NCT00348790|Secondary|To Correlate the Response Rates With Expression of Certain Types of Genes|Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes|At the end of study treatment||||||
154117|NCT00351039|Secondary|Quality of Life (QOL)|"The Scales we were intending to use were:~Instrumental Activities of Daily Living (IADL): Range of Scale 0 (Best) to 8 (Worst).~Cumulative Illness Rating Scale-Geriatric (CIRS-G): Range of Scores 1(Best) to 18 (Worst).~Functional Assessment of Cancer Therapy-Lung (FACT-L): Range of Scores 0 (Best) to 48 (Worst).~Fatigue Symptom Inventory (FSI): Range of Scores 0(Best) to 121 (Worst).~Each scale would have been evaluated independently. Since the study was not completed and closed early due to poor accrual, none of the QOL parameters were analyzed."|26 Months|Since no patients were accrued to the Phase II component of the trial, 0 patients were analyzed for these scales.||Units on a scale||95% Confidence Interval|Median
154118|NCT00351039|Secondary|Number of Patients Who Responded to Treatment|"Phase I:~Response Evaluation Criteria In Solid Tumors (RECIST)Criteria was used for Response. Partial Response (PR) is defined as at least a 30% decrease in the sum of Longest Dimention (LD) of target lesions taking as reference the baseline sum LD."|26 Months|8 patients were accrued to the Phase I component of the trial. No patients were accrued to the Phase II component of the trial.||Participants|||Number
154119|NCT00351039|Secondary|One-year Survival(1-year S)|Secondary Objective: One-year survival(1-year S) in patients with advanced NSCLC treated with this regimen.|26 Months|Had the study been completed as planned we would have measured the One-year Survival. This study was closed early due to poor accrual.||Participants|||Number
154120|NCT00351000|Primary|Change From Baseline on Fasting Insulin|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6|||microIU/L||Standard Deviation|Mean
154121|NCT00351000|Primary|Change From Baseline in Fasting Glucose|Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)|baseline, week 6|||mg/dL||Standard Deviation|Mean
154122|NCT00350870|Primary|Change in Cocaine Use by Urine Toxicology Results|We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.|12 weeks|||percentage of negative urines||Standard Deviation|Mean
154123|NCT00350870|Primary|Change in Cocaine Use by Self Report|Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.|12 weeks|||percentage of days abstinent||Standard Deviation|Mean
154124|NCT00350844|Secondary|Compliance|Secondary outcome measures included compliance; laboratory measures of therapy-related toxicity; laboratory biomarkers for hemolysis, oxidative stress and endothelial injury; and quality of life measures by Child Health Questionnaire (CHQ).|Throughout study||||||
154125|NCT00350844|Primary|Tricuspid Regurgitant Jet Velocity|Primary outcome measure was tricuspid regurgitant jet velocity (TRJV) by echocardiogram after 6 and 12 months of hydroxyurea therapy.|6 and 12 months after HU therapy begins|Study was terminated and 0 participants were analyzed.|||||
154126|NCT00350792|Secondary|Estimated Probability of One Year Progression-free Survival|Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.|baseline to measured progressive disease or death, 1 year|Six patients were censored as they had not experienced a qualifying event (death or first disease progression) at the time of data cut-off.||percentage of patients||95% Confidence Interval|Median
154127|NCT00350792|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 14.5 months)|Twenty patients were censored as they were still alive at the time of the data cut-off.||months||95% Confidence Interval|Median
154128|NCT00350792|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.||weeks||95% Confidence Interval|Median
154129|NCT00350792|Other Pre-specified|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to six 21-day cycles)|All treated patients. 29 patients were censored.||weeks||Standard Error|Mean
154130|NCT00350792|Primary|Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)|Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.|baseline to measured objective tumor response (up to six 21-day cycles)|Patients qualified for tumor response analysis: treated patients, with measurable advanced non-small cell lung cancer (NSCLC) disease and at least one tumor assessment after the patient received at least a first cycle of chemotherapy (unless early progression occurs, including early clinical progressions confirmed by the assessment committee).||percentage of participants|||Number
154131|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
154170|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||grams per liter (g/L)||Standard Deviation|Mean
154132|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
154133|NCT00350779|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 54, the last non-baseline observed measurement was carried forward to Week 54.||Percent||95% Confidence Interval|Least Squares Mean
154134|NCT00350779|Secondary|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and Week 18|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.||mg/dL||95% Confidence Interval|Least Squares Mean
154135|NCT00350779|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.||mg/dL||95% Confidence Interval|Least Squares Mean
154136|NCT00350779|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 18 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 18, the last non-baseline observed measurement was carried forward to Week 18.||Percent||95% Confidence Interval|Least Squares Mean
154137|NCT00350727|Primary|Progression-free Survival at 6 Months|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used. The participants who are still alive and whose follow-up extends to at least 6 months are considered At Risk.|Date of the first dose of study drug to 6 months|All-treated Population for Phase II||participants|||Number
154138|NCT00350727|Primary|Overall Response (OR) in Phase II Based on an Independent Radiologist's Review|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment||participants|||Number
154139|NCT00350727|Secondary|Time to Disease Progression or Death Due to Any Cause||Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II||days||95% Confidence Interval|Median
154140|NCT00350727|Secondary|Progression-free Survival|Progression-free survival (PFS) analysis was performed on all participants. PFS is presented as the number of participants experiencing disease progression or death due to any cause. Participants who are alive and have not progressed at the time of analysis are considered censored, and the date associated with the last visit with disease assessment will be used.|Date of the first dose of study drug to the date of documented and confirmed progression by Mac Donald criteria, or to date of death due to any cause (up to Day 878)|All-treated Population for Phase II||participants|||Number
154141|NCT00350727|Primary|Overall Response (OR) in Phase II Based on the Investigator-assigned Response|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population for Phase II who also had a response assessment.||participants|||Number
154142|NCT00350727|Primary|Overall Response (OR) in Phase II Based GlaxoSmithKline's Evaluation|OR is the number of participants whose response was classified as a complete response or partial response (disappearance of enhancing tumor (ET) or reduction of ET by >=50%, respectively, on consecutive scans [CS] >=1 month (m) apart, off steroids, and neurologically stable/improved), progressive disease (increase of ET of >=25% on CS >=1 m apart or neurologically worse, and steroids stable/increased), or stable disease (all other situations) per MacDonald criteria. Participants were evaluated with magnetic resonance imaging. Baseline and the 4- and 8-w assessments are categorized as <8 w.|Date of first dose of study drug to date of documented and confirmed progression, or to date of death due to any cause (assessed at baseline, 4 and 8 weeks, and every 8 weeks thereafter until study withdrawal; up to Day 878)|All-treated Population in Phase II who also had a response assessment||participants|||Number
154379|NCT00348790|Secondary|Determine Efficacy (Radiographic and Clinical Improvement)|Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment|At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment||||||
154143|NCT00350727|Primary|Number of Participants Experiencing a Dose-limiting Toxicity at the Indicated Dose|A dose-limiting toxicity (DLT) is defined as predefined adverse events or events that prevented participants from receiving 75% of their scheduled doses or from starting their next treatment period. The dose at which no more than 1 out of 6 participants experiences a DLT is defined as the optimally tolerated regimen. The OTR is important because it determines the highest dose combination that can be given without significant toxicity.|Cycle 1 in Phase I (up to Day 28)|All-treated Population for Phase I||participants|||Number
154144|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||seconds (sec)||Standard Deviation|Mean
154145|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phases I and II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||ratio||Standard Deviation|Mean
154146|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
154147|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||percent||Standard Deviation|Mean
154148|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||grams per Liter (g/L)||Standard Deviation|Mean
154149|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.||nanomoles per liter (nmol/l)||Standard Deviation|Mean
154150|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||milliunits per liter (mU/L)||Standard Deviation|Mean
154151|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline. For some arms, data were not collected for either baseline or post-baseline assessments.||picomoles per liter (pmol/l)||Standard Deviation|Mean
154152|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Thyroxine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||picomoles per liter (pmol/l)||Standard Deviation|Mean
154153|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||millimoles per liter (mmol/l)||Standard Deviation|Mean
154154|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||micromoles per liter (µmol/l)||Standard Deviation|Mean
154155|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||Units per liter (U/L)||Standard Deviation|Mean
154214|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) < 7.0%, < 6.5% and < 6.0% at Week 24|Number of subjects acheiving glycemic control: HbA1c target levels of <7.0%, <6.5%, and <6.0% at Week 24.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||participants|||Number
154156|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||International Units per Liter (IU/L)||Standard Deviation|Mean
154157|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase I of the Study for Albumin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 844 days for Phase I)|All-treated Population for Phase I. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||grams per liter (g/L)||Standard Deviation|Mean
154158|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Partial Thromboplastin Time and Prothrombin Time|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Partial thromboplastin time is a performance indicator detecting abnormalities in blood clotting.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||seconds (sec)||Standard Deviation|Mean
154159|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for International Normalized Ratio (Prothrombin Time)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. Prothrombin time is a measure of the extrinsic pathway of coagulation that is used to determine the clotting tendency of blood. The International Normalized Ratio is the ratio of a patient's prothrombin time to a normal (control) sample.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||ratio||Standard Deviation|Mean
154160|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
154161|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hematocrit|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline. The hematocrit is the proportion of blood volume that is occupied by red blood cells.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||percent||Standard Deviation|Mean
154162|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Hemoglobin|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided hematology measurements at both baseline and post-baseline.||grams per liter (g/L)||Standard Deviation|Mean
154163|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total T3|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||nanomoles per liter (nmol/l)||Standard Deviation|Mean
154164|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroid Stimulating Hormone|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||milliunits per liter (mU/L)||Standard Deviation|Mean
154165|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Thyroxine and Free T3 (Triiodothyronine)|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||picomoles per liter (pmol/l)||Standard Deviation|Mean
154166|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Calcium, Glucose, Potassium, Magnesium, Inorganic Phosphorus, Sodium, and Urea|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||millimoles per liter (mmol/l)||Standard Deviation|Mean
154167|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Total Bilirubin and Creatinine|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||micromoles per liter (µmol/l)||Standard Deviation|Mean
154168|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Amylase and Lipase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||Units per liter (U/L)||Standard Deviation|Mean
154169|NCT00350727|Primary|Mean Change From Baseline to Maximum Value in Phase II of the Study for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the maximum changed value in the study minus the value at Baseline.|Baseline to study completion (up to 878 days for Phase II)|All-treated Population for Phase II. Data are presented for only those participants who provided chemistry measurements at both baseline and post-baseline.||International Units per Liter (IU/L)||Standard Deviation|Mean
154171|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Heart Rate|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. bpm, beats per minute.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.||participants|||Number
154172|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Diastolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.||participants|||Number
154173|NCT00350727|Primary|Number of Participants With the Indicated Change From Baseline to Study Completion in Systolic Blood Pressure|Each on-study and follow-up laboratory parameter and vital sign was compared to the participant's baseline (BL) values to investigate what changes occurred. mmHg, millimeters of mercury.|Baseline to study completion (up to 844 days for Phase I, up to 878 days for Phase II)|All-treated Population (all participants who were given any dose of study medication) for Phases I and II. One participant withdrew in Phase I due to death; change from baseline was not calculated for this participant.||participants|||Number
154174|NCT00350727|Secondary|Phase II: Plasma Concentrations of the Circulating Biomarkers VEGF, sVEGFR-1, and sVEGFR-2.||Completed during first cycle of treatment.||||||
154175|NCT00350727|Secondary|Phase II: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, Tmax, and C24 of Pazopanib and Lapatinib, as Appropriate, When Administered Together in Combination With Non-EIAC.||Completed during first cycle of treatment.||||||
154176|NCT00350727|Secondary|Phase I: Pharmacokinetic Parameters Including AUC(0-24), [AUC(0-12) for Patients on Twice Daily Administration], Cmax, the Time to Maximum Observed Concentration (Tmax) and C24 of Pazopanib and Lapatinib When Administered in Combination With EIAC.||Completed during first cycle of treatment.||||||
154177|NCT00350636|Secondary|Change From Baseline in Average Urine Void Volume|Change from baseline to Week 12 in average urine void volume|Change from Baseline to Week 12|||mL||Standard Deviation|Mean
154178|NCT00350636|Secondary|Baseline Average Urine Void Volume|Baseline average urine void volume|Baseline|||mL||Standard Deviation|Mean
154179|NCT00350636|Primary|Change From Baseline in Average Daily Number of Incontinence Episodes|Change from Baseline to Week 12 in average daily number of incontinence episodes|Baseline to Week 12|||Number of episodes||Standard Deviation|Mean
154180|NCT00350636|Secondary|Change From Baseline in Average Daily Urinary Frequency|Change from baseline in average daily urinary frequency|Baseline to 12 weeks|||Number of urinary episodes||Standard Deviation|Mean
154181|NCT00350636|Secondary|Baseline Average Daily Urinary Frequency|Number of daily urinary voids|Baseline|||Number of urinary episodes||Standard Deviation|Mean
154182|NCT00350636|Primary|Baseline Average Number of Daily Incontinence Episodes|Average number of daily incontinence episodes at baseline|Baseline|||Number of episodes||Standard Deviation|Mean
154183|NCT00350623|Primary|Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks||30 weeks|No data analysis was performed.|||||
154184|NCT00350532|Primary|Acetylcholine Concentration in Cerebrospinal Fluid|Acetylcholine levels in CSF after administration of intrathecal clonidine measured by High-performance liquid chromatography (HPLC).|60 minutes|There was no difference noted in acetylcholine levels in healthy subjects compared to subjects with chronic pain||picograms per milliliter (pg/ml)||Full Range|Mean
154185|NCT00350519|Secondary|Hospital Length of Stay||Surgery to hospital discharge|ITT, No formal analysis was conducted due to early termination and small sample size||days||Standard Deviation|Mean
154186|NCT00350519|Secondary|Number of pRBC Units Transfused During Study||Baseline (Day -10) to end of study (Day 32)|ITT, No formal analysis was conducted due to early termination and small sample size||units||Standard Deviation|Mean
154187|NCT00350519|Secondary|Hemoglobin Change From Baseline to End of Study|End of Study Hemoglobin minus baseline Hemoglobin|Baseline (Day-10) to end of study (Day 32)|All Subjects, No formal analysis was conducted due to early termination and small sample size||g/dL||Standard Deviation|Mean
154188|NCT00350519|Primary|Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions||Day of surgery until hospital discharge|ITT(intention to treat), No formal analysis was conducted due to early termination and small sample size||participants|||Number
154189|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [On Dopamine Medication]|Outcome is entropy change from baseline to immediate completion of 4 week intervention when participants remained on their normal dosage of dopamine medication. Entropy is quantitative index of facial movement that is computed from changes in pixel intensity as the face moves. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity. Greater expressivity is desired outcome.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Based on individuals who completed baseline and post-treatment assessment following 4 weeks of intervention. One individual from each treatment group dropped out during the first week of intervention and were not included in analyses.||Units on a scale||Standard Deviation|Mean
154190|NCT00350402|Other Pre-specified|Change From Baseline in Maximal Inspiratory Pressure (MIP)|The dependent variable is the change in maximal inspiratory pressure (MIP) from baseline to immediate completion of 4-week intervention. MIP refers to how much air pressure force an individual creates by inhaling through the mouth as hard as possible. This was measured over 5-7 trials by placement of lips around a mouthpiece attached to a calibrated fluke digital pressure gauge. From these trials, an average maximum inspiratory pressure (MIP) was computed. This was done at baseline and post-treatment. Greater MIP changes correspond to greater treatment-related effects of exercise.|Baseline and 4 weeks (i.e., immediate after 4-week intervention)|Included participants who underwent baseline, intervention, and post-treatment assessment. Two individuals dropped out during the first week of intervention, one from each intervention group. Additionally, there was faulty data, due to equipment failure for one individual in the sham group, thereby reducing N in this group to 19.||units of pressure (cmH20)||Standard Deviation|Mean
156124|NCT00325897|Secondary|Number of Hospital Admissions as a Result of Acute Exacerbations||Measured monthly for 12 months|||Hospitalizations|||Number
154191|NCT00350402|Secondary|Change in Parkinson Disease Quality of Life-39 Scale (PDQ-39)|The PDQ-39 is a widely used quality of life measure that is specific to Parkinson disease. Total raw score on the PDQ-39 ranges from 0 to 156. Higher scores reflect worse quality of life rating. Total score on PDQ-39 was used to compute pre-post treatment changes.|Baseline and 4 weeks (i.e., immediate post-intervention)|Participants who completed baseline,intervention, and post-intervention testing. Two individuals, one from each group, dropped out of the study during the first week of intervention.||units on a scale||Standard Deviation|Mean
154192|NCT00350402|Primary|Change in Facial Entropy Score From Baseline [Off Dopamine Medication]|"Primary outcome is change in entropy score from baseline to immediate completion of 4 week intervention. Entropy is a computer derived index of facial movement that is computed by quantifying changes in pixel intensity as the face moves over a series of video frames. Entropy values range from 0 up to 100. Higher scores reflect greater movement and expressivity (desired). In this condition (off dopamine), entropy scores were obtained when participants were tested off their normal dopamine medications. Off-dopamine testing occurred after a 12-hour overnight washout period."|Baseline and 4 weeks (i.e., immediate after 4-week treatment)|All participants who completed baseline, intervention, and post-testing. Two participants, one from each group, dropped out during first week of intervention.||units on a scale||Standard Deviation|Mean
154193|NCT00350363|Primary|Number of Participant With Positive Culture||2 weeks|||participants|||Number
154194|NCT00350272|Primary|The Safety Profile of Elvucitabine.|Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events and the frequency of Grade 3 and Grade 4 laboratory abnormalities.|12 Weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug.||participants|||Number
154195|NCT00350272|Primary|The Proportion of Subjects With Virologic Response for 10 mg/Day Elvucitabine in HIV-1-infected Subjects by 12 Weeks Compared With the Proportion of Subjects With Lamivudine 300 mg/Day.|Proportion of subjects having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected subjects over 12 weeks compared with the proportion of subjects having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment.|12 Weeks|This primary outcome measure used the intent-to-treat population, defined as all randomized subjects who took at least 1 dose of study drug and had both a baseline HIV-1 RNA result and at least 1 HIV-1 RNA result after baseline assessment. For this analysis, all subjects who discontinued from the study before Week 12 were considered as NC=F.||percentage of participants|||Number
154196|NCT00348374|Secondary|Change From Baseline in Standard Deviation of 24-hour Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean change in standard deviation of all blood glucose values within 24-hour period. Change = mean at observation minus mean at Baseline.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
154197|NCT00348374|Secondary|Change From Baseline in 24-hour Mean Glucose Values Measured by Continuous Glucose Monitoring System (CGMS)|Mean of 24-hour Continuous Glucose Monitoring (CGMS) glucose values. Change from Baseline = mean at observation minus mean Baseline value.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
154198|NCT00348374|Secondary|Change in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire) From Week 4 to Week 24|"Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction.~Change = difference in mean Patient Satisfaction with Insulin Treatment (PSIT) score from Week 4 to Week 24."|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.||scores on scale||Standard Deviation|Mean
154199|NCT00348374|Secondary|Change From Baseline in Patient Treatment Satisfaction (as Assessed by Patient Satisfaction With Insulin Treatment [PSIT] Questionnaire)|Patient Satisfaction with insulin treatment Questionnaire (PSIT): 15-item self administered questionnaire that measures global satisfaction and two domains (subscales): convenience/ease of use and social comfort in people with type 1 and type 2 diabetes. 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The scoring of responses to each item is analyzed so that a higher item score indicates more satisfaction. Change = mean Patient Satisfaction of Insulin Treatment (PSIT) score at observation minus mean score at Baseline.|Week 4, Week 24|Due to cancellation of the EXUBERA program descriptive statistics for the Patient Satisfaction of Insulin Treatment (PSIT) Questionnaire were not provided.||scores on scale||Standard Deviation|Mean
154200|NCT00348374|Secondary|Crude Hypoglycemic Event Rate|Crude event rate = (number of events)/(subject months); severe hypoglycemic events: crude event rate = (number of events)/(100 subject months). Severe = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or unmeasured but clinical manifestestation reversed by oral carbohydrates or glucose. Non-severe events = mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||events per subject months|||Number
154213|NCT00348374|Secondary|Subjects That Attained Glycosylated Hemoglobin A1c (HbA1c) Target Levels of <7%, < 6.5%, and < 6.0% Without an Episode of Severe Hypoglycemia at Week 24|Number of subjects that attained HbA1c target levels of <7%, < 6.5%,and <6.0% at Week 24 without an episode of severe hypoglycemia.|Week 24|FAS; N=number of subjects with evaluable data at Baseline; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||participants|||Number
154238|NCT00350207|Secondary|Mean PEF Variability at Week 4|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 4 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
154201|NCT00348374|Secondary|Treatment Exposure for Hypoglycemic Subjects at Each Interval of the Study: Number of Subject Months of Treatment|Subject months of treatment = number of days from start of treatment to last day of active treatment + 1 day lag (total number of subjects treated * days treated), including off-drug time)/30.44. Severity: severe = subject unable to treat self, had at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams/deciliter; or not measured but clinical manifestations were reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||subject months of treatment|||Number
154202|NCT00348374|Secondary|Number of Total Hypoglycemic Events|Total number and severity of hypoglycemic events. Severe events = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable or irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild or moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||events|||Number
154203|NCT00348374|Secondary|Number of Subjects With Hypoglycemic Events|Severe event = subject unable to treat self, at least 1 neurological symptom (memory loss, confusion, uncontrollable/irrational behavior, difficulty awakening, suspected seizure, loss of consciousness), and blood glucose <= 49 milligrams per deciliter (mg/dL) or not measured but clinical manifestations reversed by oral carbohydrates or glucose. Non-severe events = events that were mild-moderate.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||participants|||Number
154204|NCT00348374|Secondary|Baseline Prandial Insulin Dose (at Each Meal) at Each Visit|Dose of inhaled insulin prior to each meal at each visit.|Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||mg||Standard Deviation|Mean
154205|NCT00348374|Secondary|Change From Baseline in Insulin Glargine Dose at Each Visit (Office and/or Phone)|Change from Baseline in insulin glargine at each visit. Change = mean at observation minus mean Baseline observation. Basal dose = injection of basal insulin (IU) (insulin glargine).|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Safety population: all subjects who received at least one dose of study medication; Lispro international units (IU) were converted to milligrams (mg) equivalent; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||IU||Standard Deviation|Mean
154206|NCT00348374|Secondary|Change From Baseline in Fasting Plasma Lipids|Change from baseline in fasting plasma lipids at Week 12 and Week 24. Change = observation mean minus Baseline mean.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
154207|NCT00348374|Secondary|Change From Baseline Weight at Each Visit|Change = mean body weight at observation minus mean body weight at Baseline.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF (all visits except Baseline); N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||kilograms||Standard Deviation|Mean
154208|NCT00348374|Secondary|Number of Subjects With Change From Baseline in Fasting and Postprandial Markers of Cardiovascular (CV) Risk as Determined by Standardized Meal Tolerance Tests|Cardiovascular risk markers included serum high-sensitivity C-reactive protein (hs-CRP)[mg/L], leptin (ng/mL), adiponectin (ug/mL), and spot urine microalbumin. Change = observation of mean fasting and postprandial markers of cardiovascular risk at Week 12 and Week 24 minus mean Baseline observation.|Week 12, Week 24|Due to cancellation of the EXUBERA program, too few patients participated to explore the markers of cardiovascular (CV) risks so these markers were not summarized.||participants|||Number
154209|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Lipids as Determined by Standard Meal Tolerance Tests|Change from Baseline in fasting and postprandial lipids at Week 12 and Week 24 as determined by standard meal tolerance tests. Change = value at observation minus value at Baseline. Postprandial = 120 mins after meal.|Baseline, Week 12, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
154210|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 24|Change from Baseline in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 24 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
154211|NCT00348374|Secondary|Change From Baseline in Fasting and Postprandial Plasma Glucose as Determined by Standardized Meal Tolerance Tests at Week 12|Change from Baseine in fasting and postprandial plasma glucose as determined by standardized meal tolerance tests (MTT). Change = mean value at Week 12 minus mean value at Baseline. Time 0 results are for MTT (time 0) and non MTT (implied time 0) subjects.|Baseline, Week 12|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
154212|NCT00348374|Secondary|Change From Baseline in Fasting and 2-hour Postprandial Glucose as Determined by 8-point Self-monitored Blood Glucose Profiles|Mean change from Baseline in fasting and 2-hour postprandial glucose at each visit in 8-point self-monitored blood glucose (SMBG) profiles: includes values prior to each meal (breakfast, lunch and dinner), 2 hours after each meal, at bedtime, and at 2:00 ante meridiem (a.m.) Change=observation value minus Baseline value.|Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||mg/dL||Standard Deviation|Mean
154215|NCT00348374|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Each Visit|Change in mean glycosylated hemoglobin A1c (HbA1c %) from Baseline to each visit through Week 24. Change = mean value at observation minus mean value at Baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|FAS; LOCF; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation: Exubera, Lispro, respectively.||percent||Standard Deviation|Mean
154216|NCT00348374|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at End of Treatment|Change from Baseline in glycosylated hemoglobin A1c (HbA1c %) at Week 24. Change = mean value at Week 24 minus mean value at Baseline.|Baseline, Week 24 (End of Treatment)|Full analysis set (FAS): subjects who received at least one dose of study medication, had a baseline glycosylated hemoglobin A1c (HbA1c%) measurement, and had a post-baseline HbA1C measurement; last (post-baseline) observation carried forward (LOCF). Number of subjects with HbA1c values at Baseline and Week 24: Exubera® n=81, Lispro n=90.||percent||Standard Deviation|Mean
154217|NCT00348348|Secondary|Microbial Eradication|Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
154218|NCT00348348|Secondary|Clinical Resolution|Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated|Day 8 or Day 9|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
154219|NCT00348348|Primary|Microbial Eradication|eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated|Day 5 (+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
154220|NCT00348348|Primary|Clinical Resolution|Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)|Day 5(+/- 1 day)|modified intent to treat (mITT), culture confirmed, as treated||Participants|||Number
154221|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Both Week 12 and Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Weeks 12 and 52|ITT set. NRI method was used to impute the missing values.||Subjects|||Number
154222|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Both Week 12 and Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at both Week 12 and Week 52.|Weeks 12 and 52|Analysis was on ITT subjects who completed the Double Blind period and had Week 52 evaluations while in the Double Blind period. NRI method was used to impute the missing values.||Subjects|||Number
154223|NCT00348283|Secondary|Number of Subjects With Clinical Remission (CDAI < 150) at Week 52|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 52|ITT set. NRI method was used to impute the missing values.||Subjects|||Number
154224|NCT00348283|Secondary|Number of Subjects Without Mucosal Ulceration at Week 52|The number of subjects receiving blinded study drug in each treatment group who were without mucosal ulceration at Week 52.|Week 52|The secondary efficacy analysis included the ITT subjects who had mucosal ulceration at screening. NRI method was used to impute the missing values.||Subjects|||Number
154225|NCT00348283|Secondary|Number of Subjects With Clinical Remission Crohn's Disease Activity Index (CDAI) < 150 at Week 12|Clinical remission is defined as a CDAI less than 150. A lower score correlates with less severe Crohn's disease activity. The CDAI range for this study was 0 to 961.|Week 12|ITT set. NRI method was used to impute the missing values.||Subjects|||Number
154226|NCT00348283|Primary|Number of Subjects Without Mucosal Ulceration at Week 12|Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.|Week 12|Analysis was on ITT subjects with mucosal ulceration at Screening. Subjects who did not have endoscopy at Week 12 were considered to have mucosal ulceration at Week 12 (NRI). If subjects had endoscopy at Week 8, the endoscopy results from Week 8 were carried forward to Week 12 for the primary efficacy analysis.||Subjects|||Number
154227|NCT00350220|Primary|Peak Arterial Lactate Level|Peak arterial lactate level for the 48 hour post-op study period.|48 hours|||mmol/l||Standard Deviation|Mean
154228|NCT00350220|Secondary|Mortality Before Hospital Discharge||30 days||||||
154229|NCT00350220|Secondary|Volume of Blood Transfused||3 days||||||
154230|NCT00350220|Secondary|Length of Vasoactive Agent Administration||3 days||||||
154231|NCT00350220|Secondary|Length of Oxygen Use||3 days||||||
154232|NCT00350220|Secondary|Length of Mechanical Ventilation||3 days||||||
154233|NCT00350220|Secondary|Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.||3 days||||||
154234|NCT00350220|Primary|Mean Arterial Lactate Level|Mean arterial lactate for the first 48 hours post-op.|48 hours|||mmol/L||Standard Deviation|Mean
154235|NCT00350207|Secondary|Mean PEF Variability at Week 16|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 16 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
154236|NCT00350207|Secondary|Mean PEF Variability at Week 12|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 12 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
154237|NCT00350207|Secondary|Mean PEF Variability at Week 8|PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%|After 8 weeks of treatment|FAS||ratio expressed in percent||Standard Error|Least Squares Mean
154239|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 5|Pulse rate collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||bpm||Standard Deviation|Mean
154240|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 4|Pulse rate collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||bpm||Standard Deviation|Mean
154241|NCT00350207|Secondary|Pulse Rate in Conjunction With Spirometry at Visit 3|Pulse rate collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||bpm||Standard Deviation|Mean
154242|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5|Diastolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
154243|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4|Diastolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
154244|NCT00350207|Secondary|Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3|Diastolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
154245|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 5|Systolic blood pressure collected in conjunction with spirometry at 16 weeks|After 16 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
154246|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 4|Systolic blood pressure collected in conjunction with spirometry at 12 weeks|After 12 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
154247|NCT00350207|Secondary|Systolic Blood Pressure in Conjunction With Spirometry at Visit 3|Systolic blood pressure collected in conjunction with spirometry at 6 weeks|After 6 weeks of treatment|Treated set. Some patients discontinued the trial between Visits. Thus these patients are in the efficacy analysis for the respective period (are added in the participant flow) but they have no safety blood pressure/pulse rate measurements, because blood pressure and pulse rate were measured at Visits||mmHg||Standard Deviation|Mean
154248|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 5|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154249|NCT00350207|Secondary|Mini-AQLQ Overall Score at Visit 4|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154250|NCT00350207|Secondary|Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3|Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value|After 6 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154251|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5|Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154252|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4|Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154253|NCT00350207|Secondary|Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3|Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment|After 6 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154257|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 16"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154258|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 12"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154259|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 8"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154260|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Experience Wheeze or Cough During the Day at Week 4"|Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154261|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 16"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154262|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 12"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154263|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 8"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154264|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Much Shortness of Breath Did You Experience During the Day at Week 4"|Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154265|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 16"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154266|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 12"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154267|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 8"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154268|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Limited Were You in Your Activities Today Because of Your Asthma at Week 4"|Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154269|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154270|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154271|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154272|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms During the Day at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154273|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 16"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154274|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 12"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154275|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms This Morning at Week 8"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154276|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question How Were Your Asthma Symptoms in the Morning at Week 4"|Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154277|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 16"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 16 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154278|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 12"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 12 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154279|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 8"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 8 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154280|NCT00350207|Secondary|"Mean Weekly Score for Asthma Control Diary Question Did You Wake up During the Night Due to Asthma at Week 4"|Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value|After 4 weeks of treatment|FAS||Unit on a scale||Standard Error|Least Squares Mean
154281|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16|Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154282|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12|Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154283|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8|Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154284|NCT00350207|Secondary|Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4|Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154285|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16|Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose|After 16 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154286|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12|Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose|After 12 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154287|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8|Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose|After 8 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154288|NCT00350207|Secondary|Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4|Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose|After 4 weeks of treatment|FAS||L||Standard Error|Least Squares Mean
154289|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 16|Mean weekly evening peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154290|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 12|Mean weekly evening peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154291|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 8|Mean weekly evening peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154292|NCT00350207|Secondary|Mean Weekly Evening Peak Expiratory Flow at Week 4|Mean weekly evening peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154293|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 16|Mean weekly morning peak expiratory flow at week 16, pre-dose|After 16 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154294|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 12|Mean weekly morning peak expiratory flow at week 12, pre-dose|After 12 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154295|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 8|Mean weekly morning peak expiratory flow at week 8, pre-dose|After 8 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154296|NCT00350207|Secondary|Mean Weekly Morning Peak Expiratory Flow at Week 4|Mean weekly morning peak expiratory flow at week 4, pre-dose|After 4 weeks of treatment|FAS||L/min||Standard Error|Least Squares Mean
154297|NCT00350207|Primary|Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial|Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit|baseline and after 16 weeks of treatment|The Full analysis set (FAS) included patients who received at least one dose of randomised study medication and who had at least four patient diary records for at least one efficacy endpoint in any week after the first administration of the randomised treatment and baseline data for the corresponding efficacy endpoint.||L/min||Standard Error|Least Squares Mean
154298|NCT00350142|Secondary|Median Overall Survival Time|The survival time for each patient is measured as the number of months from randomization until the time of death from any cause. The median survival time is computed using Kaplan Meier curves.|up to 3 years|||months||Full Range|Median
154299|NCT00350142|Primary|Rate of Local Control|"The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site.~Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression."|up to 3 years|||participants|||Number
156125|NCT00325897|Secondary|Number of Emergency Department Visits as a Result of Acute Exacerbations||Measured monthly for 12 months|||Visits|||Number
154300|NCT00349921|Primary|Number Meeting Success Criterion|Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection|baseline and 2 hours|The primary outcome measure will be % change in pain report 2 hr following injection, using a response criterion of 30% reduction in ongoing pain.||participants meeting success criterion|||Number
154301|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (Post Procedure)|Percent Stenosis assessed immediately post procedure from pre procedure|Post Procedure|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.||Percentage Change from PreProcedure||Standard Deviation|Mean
154302|NCT00349908|Primary|Technical Feasibility- Percent Stenosis (6 mo Post Procedure)|Percent Stenosis assessed 6 mo Post Procedure from pre-procedure|6 mo|Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.||Percentage change from PreProcedure||Standard Deviation|Mean
154303|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)|Successful stent/coil placement assessed at 6 mo post|6 mo|||Percentage of stable stent/coil placemen|||Number
154304|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)|6 Months post|6 mo|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.||percent occlusion||Full Range|Mean
154305|NCT00349908|Primary|Technical Feasibility- Percent Occlusion (Post Procedure)|Occlusion evaluated immediately post procedure|post procedure|Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.||percent occlusion||Full Range|Mean
154306|NCT00349908|Secondary|The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.|An adverse event was defined as any untoward medical occurrence in a subject.|6 months|Group 1 and Group 2 were analyzed separately. In group 1 Atherosclerosis, 25 unique adverse events were reported in 8 of the 10 eligible subjects. In group 2 aneurysm, 28 unique adverse events were reported in 9 of the 10 eligible subjects.||Number of adverse events|||Number
154307|NCT00349908|Primary|Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)|Successful placement of the product assessed immediately post procedure|post procedure|||percentage of stable placement|||Number
154308|NCT00349752|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab Pegol 400 mg) subjects randomized, 23 and 26 subjects respectively had available values at Baseline and Week 38 and are included in the summary based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
154309|NCT00349752|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38|The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 23 and 27 subjects respectively had available values at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
154310|NCT00349752|Secondary|Change From Baseline in CDAI Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0, Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively had available values at Baseline and at Week 38 and are included in the summary based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
154311|NCT00349752|Secondary|Crohn's Disease Activity Index (CDAI) Score at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 38|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 22 and 27 subjects respectively are included in the summary of the Week 38, based on the intention-to-treat (ITT) population.||score on a scale||Standard Deviation|Mean
154312|NCT00349752|Secondary|Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.|6-week run-in period, 38-week double-blind treatment period|Of the 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 86 in each group had available values at the 6-week run-in period and over the 38-week double-blind treatment period.||mg per week||Standard Deviation|Mean
154313|NCT00349752|Secondary|Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period|The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.|Over the 48-week study period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.||mg||Standard Deviation|Mean
154314|NCT00349752|Secondary|Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period|The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.|Over the 38-week double-blind treatment period|87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized are included in the summary based on the intention-to-treat (ITT) population. Of the 87 subjects in the placebo group, 1 subject taking a daily dose of 3g with a rectal route has been excluded from the analysis.||mg per week||Standard Deviation|Mean
154315|NCT00349752|Secondary|Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|During the 38-week double-blind treatment period|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0||days||Standard Deviation|Mean
154316|NCT00349752|Secondary|Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38|A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]|Week 38|Of 87 (Placebo) and 87 (Certolizumab pegol 400 mg) subjects randomized, 85 and 87 subjects respectively are included in summary of Week 38, based on conditional intention-to-treat population, consisting of all randomized subjects who received at least one injection of study medication, excluding those who were not in remission (CDAI>150) at Week 0||percentage of subjects|||Number
154317|NCT00349752|Secondary|Percentage of Subjects With Continuous Remission Off Steroids at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.||percentage of subjects|||Number
154318|NCT00349752|Primary|Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38|The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.|Week 38|Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.||percentage of subjects|||Number
154319|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.~HHD analysis was performed using Percent Change from Baseline. Each subject’s baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||Percent change per 12 weeks||Standard Error|Mean
154320|NCT00349622|Secondary|Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year|"The ALS-Specific Quality of Life Scale (ALSQOL). was developed, tested, and validated in subjects with ALS, and is not a health-related quality of life scale. The scale consists of 59 questions that ask about severity of the symptoms of ALS, mood and affect, intimacy, and social issues. Each question for the ALSQOL is scored from 0-10. With 59 questions, total score ranges from 0-590 with scores simply added, with 590 representing highest quality of life. However since 10 is maximally weighted towards negative values on some questions and positive values on others, the following questions must have results transposed (Simply reverse the scale, for instance 10=0 and 0=10) prior to analysis: 1-10, 11, 16, 19, 24, 26, 28, 32, 35, 36, 38, and 41. Optional items are 50, 53, 56, and 59. These questions are not included on any scale or in any quantitative analyses.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||units on a scale per 12 weeks||Standard Error|Mean
154321|NCT00349622|Secondary|Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year|"Hand-held Dynamometry (HHD) is used to evaluate muscle strength. Six proximal muscle groups were examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension). In addition, wrist extension, first dorsal interosseous contraction and ankle dorsiflexion were measured bilaterally.~HHD analysis was performed using Percent Change from Baseline. Each subject’s baseline strength value for each muscle group is considered 100%. During successive visits strength for each muscle group was measured using HHD and was calculated as a percentage of the initial baseline value recorded. Upper extremity and lower extremity values were calculated as the sum of all tests for that extremity to create one megascore for upper and one megascore for lower extremity muscles.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||Percent change per 12 weeks||Standard Error|Mean
154322|NCT00349622|Secondary|Change in % Vital Capacity From Screening to One Year|"Vital Capacity is measured as the percent predicted per subject based on age, gender, and height, and is performed as a Slow Vital Capacity.~This outcome measure calculation is based on measurements every 12 weeks from the Baseline Visit up until one year."|Every 12 weeks for one Year|||percent change in VC per 12 weeks||Standard Error|Mean
154378|NCT00348790|Secondary|To Describe the Response Rate and Overall Survival in This Patient Population|Response rate and overall survival will be assessed by MRI scan every 2 months while on study treatment and follow-up will be done at regularly scheduled office visits up to 1 year after discontinuation of study treatment.|Every 2 months for up to 1 year after study treatment||||||
154323|NCT00349622|Primary|Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year|"Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised (ALSFRS-R) is a quickly administered (five minute) ordinal rating scale used to determine patients' assessment of their capability and independence in 12 functional activities/questions. The 12 functional activities/questions are rated on a scale of 0 to 4 for a total scoring range of 0-48, with 48 representing optimal function. All 12 activities are relevant in ALS.~This outcome measure calculation is based on measurements every 8 weeks from the Baseline Visit up until one year."|Every 8 weeks for one year|||units on a scale per 8 weeks||Standard Error|Mean
154324|NCT00349622|Primary|Survival|Survival is presented as median day of survival for each group. Survival is defined as time to death, tracheostomy or the initiation of permanent assisted ventilation (PAV).|From date of randomization until date of death, tracheostomy, or the initiation of permanent assisted ventilation (PAV). This was assessed at time of each participant's drug discontinuation and every 2 months thereafter for the life of the study (6 yrs)|||days||95% Confidence Interval|Median
154325|NCT00349466|Secondary|Use of Artificial Tears|daily use of REFRESH TEARS® Lubricant Eye Drops artificial tears supplied to each patient was recorded in diaries provided to patients|12 weeks||||||
154326|NCT00349466|Secondary|Tear Meniscus (TM) Height|Indicator of tear volume. TM was recorded on a scale from 0-3, with 0=none, 1=trace, 2=normal, and 3=high.|12 weeks||||||
154327|NCT00349466|Secondary|Dry Eye Symptom Score|consists of 12 questions designed to assess the symptoms of ocular irritations, covering three areas: ocular symptoms, environmental triggers and visionrelated function|12 weeks||||||
154328|NCT00349466|Secondary|Proportion of Clinical Success|improvement of ≥25% over baseline at Week 12 in BUT, superficial punctate keratitis as assessed by FS, or ST|12 weeks||||||
154329|NCT00349466|Primary|Fluorescein Staining of the Cornea|Severity of corneal epithelial loss as graded by Fluorescein Staining of the cornea, assessed on a 0-4+ scale with 0 = none and 4+ = severe de-epithelialization, expressed as number of participants with >25% improvement at Week 12 relative to baseline|Baseline and 12 weeks|Per protocol, observed values||Participants|||Number
154330|NCT00349466|Primary|Tear Break-Up Time|time elapsed between a complete blink and the development of the first random dry spot on the tear film|12 weeks||||||
154331|NCT00349466|Primary|Schirmer Test (ST)|involved placing a standardized paper tear strip inside the lower eyelid for 5 minutes. The tear strip was then removed and the length of the strip that was wet from tears was measured in millimeters|12 weeks||||||
154332|NCT00349388|Secondary|Improved Medication Compliance.|unable to measure since no one enrolled in second arm. Therefore, no comparisons can be made.|overall study||||||
154333|NCT00349388|Primary|Once Daily Dosing Works as Well a Multiple Dosing a Day.|subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported|overall study|cannot analysze primary outcome because no subjects were enrolled in the once a day dose arm. Study was terminated due to lack of enrollment|||||
154334|NCT00349349|Secondary|Volume of Distribution at Steady State (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Vss is defined as the volume of distribution at steady state of ofatumumab.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
154335|NCT00349349|Secondary|Clearance (CL) After Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
154336|NCT00349349|Secondary|Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)|Half-life ( t1/2) is defined as the terminal half-life and is the time required for the amount of drug in the body to decrease by half.|Visit 9 (Week 7) and Visit14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||hours||Geometric Coefficient of Variation|Geometric Mean
154337|NCT00349349|Secondary|AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)|AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinity. AUC(0-tau) is AUC from the start of infusion over the dosing interval.|Visit 9 (Week 7) and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit for whom the parameter could be calculated. Participants withdrawn during the study were not analyzed.||Milligrams x hour per liter (mg.h/L)||Geometric Coefficient of Variation|Geometric Mean
154338|NCT00349349|Secondary|Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)|Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the trough serum concentration (measured concentration at the end of a dosing interval [taken directly before the next administration]). No drug was present before the first infusion; therefore, there are no Ctrough results for Dose 1|Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24)|FAS. Data were provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.||Milligrams per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
154339|NCT00349349|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up)|FAS||participants|||Number
154362|NCT00349336|Secondary|Maximum Serum Concentration of Bevacizumab at Steady State|Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||ug/mL||Standard Deviation|Mean
154340|NCT00349349|Secondary|Number of Participants With Complete Resolution of Splenomegaly|Participants with complete resolution of enlarged spleen (splenomegaly) were defined as those with an enlarged palpable spleen at baseline followed by the absence of splenomegaly post-baseline (i.e., the spleen was of normal size). Spleen size was assessed by physical examination and documented as “centimeters” under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines).|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with splenomegaly at baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline splenomegaly and a post-baseline assessment are included.||participants|||Number
154341|NCT00349349|Secondary|Number of Participants With Improvement in Neutropenia|Low levels of neutrophils (neutropenia) may increase the risk of developing serious infections and may be considered an adverse condition and evaluated on the NCI CTC with a grade. Improvement in neutropenia is defined as a decrease from Visit 2 (baseline) by at least one NCI CTC grade. Improvement is defined as a decrease from Visit 2 by at least one NCI CTC grade.|Baseline (Visit 2) to Week 28|FAS. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.||participants|||Number
154342|NCT00349349|Secondary|Number of Participants With Complete Resolution of Hepatomegaly|Participants with complete resolution of enlarged liver (hepatomegaly) were defined as those with an enlarged palpable liver at baseline followed by the absence of hepatomegaly post- baseline (i.e., the liver was of normal size). Liver size was assessed by physical examination and documented as “centimeters” under the costal margin with relative changes in spleen size in 1 dimension calculated based on palpated numeric measurements (as per the 1996 NCIWG guidelines).|Baseline (Visit 2) until Week 24|FAS. Data were provided for the number of participants with hepatomegaly from baseline attending each visit. Participants withdrawn during the study were not analyzed. Only participants with baseline hepatomegaly and a post-baseline assessment are included.||participants|||Number
154343|NCT00349349|Secondary|Number of Participants With Improvement in Thrombocytopenia (Thromb.)|Improvement in thromb. is defined as a decrease from Visit 2 by >=1 National Cancer Institute Common Terminology Criteria (NCI CTC) grade. Thromb. is defined as low platelet counts resulting from refractory CLL, damage from prior treatment, advanced age, or reduced bone marrow function and can be considered as an adverse condition. Adverse events (AEs) such as thromb. in a cancer indication are graded on a scale determined by the NCI called the NCI CTC: lowest, grade 1; highest, grade 5 (death). Changes in this grading can assess improvements or declines in the severity of the AE.|Baseline (Visit 2) to Week 28|FAS. Only those participants remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.||participants|||Number
154344|NCT00349349|Secondary|Number of Participants With Improvement in Hemoglobin|The number of participants (par.) who had improvement in hemoglobin levels >=11 grams (g)/deciliter (dl) (6.8 millimoles/liter) or 50% improvement over baseline was measured.|Baseline (Visit 2) to Week 28|FAS. Par. were excluded from analysis if they received treatment of red blood cells (RBCs), received transfusions or a RBC growth factor (erythropoietin), died, withdrew from the trial, or began next CLL treatment. Only those par. remaining in the study at Week 28 were analyzed. No par. in the “Other” treatment arm met the criteria for analysis.||participants|||Number
154345|NCT00349349|Secondary|Number of Participants Who Were Positive, Negative, or Had Missing Data for the Indicated Fluorescence in Situ Hybridization (FISH) Prognostic Factors at Screening|The number of participants (par.) who were positive, negative, or had missing data for the following prognostic factors indicative of altered responsiveness to treatment and/or survival was measured: 17p-, 11q-, +12q, 6q-, 13q-. Par. were assessed by FISH for these chromosomal abnormalities known tobe prognostic for time to treatment and survival when detected at diagnosis. Par. were categorized by the chromosomal abnormality detected: 17 p deletion, 11q deletion (but not 17 p deletion), 12 q trisomy (but not 17 p or 111q deletion), 13q deletion only, and no chromosomal abnormalities found.|Screening (Visit 1, <=14 days prior to Visit 2)|FAS. Par. were categorized hierarchically (by severity of abnormality): par. with a 17 p deletion (D); par. with an 11q D, but not a 17 p D; par. with 12q trisomy, but not a 17p or 11q D; par. with no aberrations found; par. with a 13q D as the sole aberration; and par. with 6q D (and not any of the above categories). Some par. had missing data.||participants|||Number
154346|NCT00349349|Secondary|Number of Participants With Improvement on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at Week 24|ECOG performance status is a measure of the participant’s ability to carry out activities of daily living on 6-point scale (0=fully active, 1=restricted in physically activity, ambulatory, 2=ambulatory [>50% of waking hours], 3=capable of only limited self care, 4=completely disabled, 5=Dead). Improvement in ECOG performance status is defined as a decrease from baseline by at least one score on the ECOG scale.|Baseline (Visit 2) and Week 24|FAS. Data were provided for participants (par.) with an ECOG score >0 at baseline attending each visit. Par. withdrawn from the study were not analyzed. (55 par. had an ECOG performance status of 0 at baseline and therefore did not have the opportunity to improve. No par. with an ECOG score of 0 at baseline worsened during the trial.)||participants|||Number
154347|NCT00349349|Secondary|Number of Participants With Complete Resolution of Lymphadenopathy|Participants with complete resolution of lymphadenopathy (disease involving the lymph nodes) were defined as those in whom all observed lymph nodes were of normal size (all nodes <1 centimeters) as determined by physical examination assessed by the investigator. All palpable lymph node sizes were recorded.|Baseline (Visit 2) to end of study (up to Week 24)|FAS. Data were provided for the number of participants with lymphadenopathy at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline lymphadenopathy remained free of lymphadenopathy during the trial.)||participants|||Number
154348|NCT00349349|Secondary|Number of Participants With Complete Resolution of Constitutional Symptoms at Week 24|Participants with complete resolution of constitutional symptoms were those in whom no constitutional symptoms, such as night sweats, weight loss, and fever or extreme fatigue, were observed.|Baseline (Visit 2) and Week 24|FAS. Data were provided for the number of participants with constitutional symptoms at baseline attending each visit. Participants withdrawn during the study were not analyzed. (Participants without baseline constitutional symptoms did not experience new constitutional symptoms during the trial period.)||participants|||Number
154349|NCT00349349|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) to Week 24 (Visit 14)|Tumor size and change in tumor size will be measured by the absolute value of and the percent change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24 (Visit 14). Percent change from Visit 2 (Baseline, Week 0) = (value at Week 24 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 24 (Visit 14)|FAS||percent change in tumor size||Full Range|Median
154350|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD20+ Cell Counts|The peripheral blood for each participant was collected and analyzed for CD5+CD20+ cell counts. CD is “cluster of differentiation,” is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 7 (Visit 9)|FAS||percent change in cell counts||Full Range|Median
154351|NCT00349349|Secondary|Percent Change From Baseline to Week 7 in Peripheral CD5+CD19+ Cell Counts|The peripheral blood for each participant was collected and analyzed for CD5+CD19+ cell counts. CD is “cluster of differentiation,” is a cell surface marker for immunophenotyping, and, in this case, is a surrogate for B cell malignancy (indicates malignant B cells). Percent change from Visit 2 (Week 0, Baseline) = (value at Week 7 minus value at Week 0 divided by value at Week 0) x 100.|Baseline (Visit 2) until Week 7 (Visit 9)|FAS||percent change in cell counts||Full Range|Median
154352|NCT00349349|Secondary|Overall Survival|OS is defined as the time from allocation to death. OS will also be subgrouped for responders and non-responders.|Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks)|FAS||months||95% Confidence Interval|Median
154353|NCT00349349|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months])|FAS||months||95% Confidence Interval|Median
154354|NCT00349349|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression/death. Per the IRC, if the participant had progression between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity/other reason, new anti-cancer treatment, and death/progression after 2 or more missed visits in a row, the endpoint was censored. Clinical progression is not considered as progression endpoint.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS||months||95% Confidence Interval|Median
154355|NCT00349349|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|Start of treatment (Week 0 of Visit 2) until Week 24|FAS||months||95% Confidence Interval|Median
154356|NCT00349349|Primary|Number of Participants (Par.) Classified as Responders and Non-responders for Objective Response as Assessed by an Independent Endpoint Review Committee (IRC) in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) were classified as responders, while those with stable disease (SD) and progressive disease (PD) were classified as non-responders. Per the NCIWG guideline (1996): CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, bone marrow sample as normocellular for age, <30% lymphocytes (LC), no lymphoid nodule; PR: a >=50% decrease in LC/lymphadenopathy; nPR: persistent nodules in bone marrow; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0 of Visit 2) until Week 24|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Participants not evaluable (NE) were due to patient withdraw, refusal, non-trial drug related AEs, and death||participants|||Number
154357|NCT00349336|Secondary|Terminal Half-life of Bevacizumab|Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||hr||Standard Deviation|Mean
154358|NCT00349336|Secondary|Volume of Distribution of Bevacizumab at Steady State|Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||L||Standard Deviation|Mean
154359|NCT00349336|Secondary|Time of Maximum Serum Concentration of Bevacizumab|Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||hr||Standard Deviation|Mean
154360|NCT00349336|Secondary|Serum Clearance of Bevacizumab|Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||L/day||Standard Deviation|Mean
154361|NCT00349336|Secondary|Minimum Serum Concentration of Bevacizumab at Steady State|Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||ug/ml||Standard Deviation|Mean
154363|NCT00349336|Secondary|Steady-state Exposure of Bevacizumab From Time Zero to Tau|Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||day*ug/mL||Standard Deviation|Mean
154364|NCT00349336|Primary|Weekly Steady-state Exposure of Bevacizumab|Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||day*ug/mL||Standard Deviation|Mean
154365|NCT00349336|Secondary|Time Zero to Last Measurable Plasma Concentration of Bevacizumab|Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.|Up to 48 weeks|42 patients participated in pharmacokinetic (PK) assessments and of those, 37 were included in the PK analysis. Two patients receiving XELOX+BV were not included in the PK analysis due to protocol violations.||day*ug/mL||Standard Deviation|Mean
154366|NCT00348933|Secondary|Change in RBC Folate||Baseline, 1 year|Analysis per protocol||ng/mL||Standard Deviation|Mean
154367|NCT00348933|Secondary|Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine.||Baseline, 1 year|analysis per protocol||mmol/L||Standard Deviation|Mean
154368|NCT00348933|Primary|Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills|"Primary:~Bayley Scales of Infant Development measures Mental Developmental Index standard scores 0 (least skilled) - 100 (most skilled) Psychomotor Developmental Index standard scores 0 (least skilled - 10 (most skilled) Vineland Adaptive Behavior Scales (VABS), Communication standard scores 0 (least skilled) - 100 (most skilled) Daily Living Skills standard scores 0 (least skilled) - 100 (most skilled) Socialization standard scores 0 (least skilled) - 100 (most skilled) Motor Skills standard scores 0 (least skilled) - 100 (most skilled) Preschool Language Scale (PLS), Auditory Comprehension 0 (least skilled) - 100 (most skilled) Expressive Communication 0 (least skilled) - 100 (most skilled)"|Baseline, 1 year|Analysis per protocol||units on a scale||Standard Deviation|Mean
154369|NCT00348881|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.~Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 to Day 7 after vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received.||Participants|||Number
154370|NCT00348881|Primary|Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.|Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.|Day 0 to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.||Participants|||Number
154371|NCT00348881|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.|1 month post third vaccination|GMTs were assessed in a subset of the participants available for the endpoint, the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
154372|NCT00348881|Primary|Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.~Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.||Participants|||Number
154373|NCT00348790|Secondary|Number of Months Patients Survive After Being Treatment on the Study.||From the date the first patient began treatment until the date the last patient became deceased.|||months||95% Confidence Interval|Median
154374|NCT00348790|Secondary|To Determine the Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas|Safety of vatalanib will be assessed by labs being done weekly|Every week while on study treatment||||||
154375|NCT00348790|Other Pre-specified|To Use the FACT BR Questionnaire to Measure Quality of Life|FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment|At baseline and then every time an MRI is performed while on study treatment.||||||
154376|NCT00348790|Other Pre-specified|Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels|Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment|MRI with MR Perfusion will be done before treatment and then every 2 months while on study treatment||||||
154380|NCT00348790|Primary|Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.|Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.|From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment|||participants|||Number
154381|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 91 patients are available for analysis||percent change||Full Range|Median
154382|NCT00348686|Secondary|Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only|Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only 201 patients are available for analysis.||percent change||Full Range|Median
154383|NCT00348686|Secondary|Change of Diastolic Blood Pressure (DBP)|"Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.~Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data."|At Baseline and 24 weeks|Last Observational carried forward||mmHg||Full Range|Median
154384|NCT00348686|Secondary|Change of Systolic Blood Pressure (SBP)|Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.|At Baseline and 24 weeks|Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.||mmHg||Full Range|Median
154385|NCT00348686|Secondary|LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index|Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.|At Baseline and 24 weeks|Only 245 patients who have reliable Echocardiac data were analyzed.||g/m^2||Full Range|Median
154386|NCT00348686|Primary|Percent Change of B Type Natriuretic Peptides (BNP) Level|Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.|At Baseline and 24 weeks|Followed Intent-to-treat analysis||Percent Change||Full Range|Median
154387|NCT00348673|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.||hrs||Full Range|Median
154388|NCT00348673|Other Pre-specified|Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.||ng/mL||Standard Deviation|Geometric Mean
154389|NCT00348673|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss)|AUCtau = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), the dosing interval was 12 hours for twice daily regimen and 24 hours for once daily regimen.|0 (pre-dose), 1, 2, 3, 4, 6, 12 hours post-dose; additional 24 hours post-dose for once daily regimen on Day 8|Per protocol pharmacokinetic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose pharmacokinetic concentration.||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
154390|NCT00348673|Secondary|Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load|Time to rebound of viral load was defined as time from the last dose (Day 8) to the time of the first occasion at which the viral load was greater than baseline value. Number of participants with rebound of viral load at specified number of days after last dose (day 8) was reported.|Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose])|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.||participants|||Number
154391|NCT00348673|Primary|Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8|Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid[HIV-1 RNA]) levels(log10 copies/milliliter[copies/mL])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.|Baseline, Day 8|Per protocol pharmacodynamic analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose viral load measurement.||log10 copies/mL||Standard Deviation|Mean
154392|NCT00348556|Secondary|Change in Urinary Sodium Excretion at 24 Hours||baseline, 24 hours after start of infusion||||||
154393|NCT00348556|Primary|Change in Glomerular Filtration Rate (GFR) at 24 Hours||baseline, 24 hours after start of infusion||||||
154394|NCT00347958|Other Pre-specified|Percentage of Participants With Tetanus and Diptheria Antibody Titers ≥ 0.1 Pre- and Post-Vaccination With Adacel®|Seroprotection: Tetanus or diphtheria titer ≥ 0.1 after Adacel® vaccination. Tetanus titers determined by enzyme-linked immunosorbent assay; diphtheria titers determined by toxin neutralization assay.|Day 28 post-vaccination|Tetanus and diphtheria antibody analyses were in all enrolled and vaccinated participants in the per-protocol population. Diphtheria antibody titers were analyzed separately for participants without and with an intervening Menactra vaccination between the previous study and Study Td518.||Percentage of Participants|||Number
154395|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Pertussis Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for Pertussis were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
154396|NCT00347958|Other Pre-specified|Geometric Mean Titers (GMTs) of Tetanus and Diphtheria Antibodies Pre- and Post-Vaccination.|Pre- and post-vaccination GMTs and their 95% confidence intervals for diphtheria were determined by toxin neutralization testing; the other antibody levels were determined by enzyme-linked immunosorbent assay testing.|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
154397|NCT00347958|Primary|Percentage of Participants With at Least 1 Solicited Injection Site and Systemic Reactions Post-Vaccination|Solicited Injection Site Reactions: Pain, Erythema/Redness, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Myalgia, Malaise.|0-14 days post-vaccination|"Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.~The solicited systemic reaction, malaise was not collected in the previous studies."||Percentage of Participants|||Number
154398|NCT00347932|Secondary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized.||Participants|||Number
154399|NCT00347932|Secondary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 8 or 9|Modified intent to treat population, culture confirmed, as randomized||Participants|||Number
154400|NCT00347932|Primary|Microbial Eradication of Baseline Bacterial Infection|Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.|Day 5 +/- 1 day|Modified Intent to treat population, culture confirmed, as randomized.||Participants|||Number
154401|NCT00347932|Primary|Clinical Resolution of Baseline Bacterial Conjunctivitis|The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection|Day 5 +/- 1 day|Modified intent to treat population, culture confirmed, as randomized||Participants|||Number
154402|NCT00347919|Secondary|Percentage of Participants With Progressive Disease at Week 12|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Participants were classified as having PD if their response at Week 12 was unknown or missing. Per Response Evaluation Criteria In Solid Tumors (RECIST), PD is defined as a >=20% increase in target lesions. IRC, independent review committee.|Week 12|Cohort 2 MITT Population||percentage of participants|||Number
154403|NCT00347919|Secondary|Time to Response (Complete or Partial Response) in Cohort 1 and Cohort 2|Time to response is defined as the time from randomization to the time of first documented evidence of a complete (CR) or partial response (PR). The time to response will depend on when the response is counted as starting. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the target dimensions of the target lesions taking as a reference the baseline sum.|The time from randomization to the time of first documented evidence of complete or partial response (up to 81.14 weeks for Cohort 1 and 44.29 weeks for Cohort 2)|MITT Population||weeks||95% Confidence Interval|Median
154404|NCT00347919|Secondary|Duration of Response in Cohort 1|Duration of response is defined as the length of time from the time from the first observation of response until progression of disease or death. Duration of response depends on two things: (1) when response is counted as starting; (2) when response is counted as ending.There were insufficient data to adequately assess duration of response for Cohort 2. IRC, independent review committee. For participants who do not progress or die, duration of response was censored at the date of last adequate assessment.|Time from first documented evidence of complete or partial response until the first documented sign of disease progression or death due to any cause (up to 106.71 weeks)|MITT Population||weeks||Inter-Quartile Range|Median
154405|NCT00347919|Secondary|Response at Week 12 for Cohort 1 and Cohort 2|The percentage of participants achieving either a complete (CR) or partial (PR) tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) is presented. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee. Participants with an unknown or missing response were treated as non-responders.|Week 12|MITT Population||percentage of participants|||Number
154406|NCT00347919|Secondary|Overall Survival for Cohort 1|Overall survival (OS) is defined as the time from randomization until death due to any cause. Participants who are alive as of the date of last contact are censored. There was insufficient follow-up to adequately assess OS for Cohort 2. Median OS cannot be presented for the lapatinib arm because the upper bound of the 95% confidence interval is undefined due to insufficient follow-up.|Randomization until death due to any cause (up to 106.43 weeks)|MITT Population||weeks||95% Confidence Interval|Median
154407|NCT00347919|Primary|Percentage of Participants With Progressive Disease at Week 12 in Cohort 1|The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.|Week 12|Cohort 1: Modified Intent-to-Treat (ITT) Population (all randomized, centrally confirmed, ErbB2 FISH-positive participants).||percentage of participants|||Number
154408|NCT00347438|Primary|Complete Pathologic Response Rate (cPR)|Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||percentage of participants|||Number
154451|NCT00345631|Secondary|Time to Device Deployment, up to 5 Minutes|Time to device deployment is defined as from the time device inserted to the time sheath removed|From device inserted to introducer sheath removal|Intent to Treat population with non-missing time data, excluding MC patients. Patients in the MC arm didn't deploy the device.||Hour||Standard Deviation|Mean
154409|NCT00347438|Primary|Complete Clinical Response Rate (CCR)|Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||percentage of participants|||Number
154410|NCT00347438|Primary|Partial Clinical Response Rate (PR)|Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||participants|||Number
154411|NCT00347438|Primary|Overall Clinical Response Rate (OCR)|Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.|After the first three cycles of therapy, an average of 9 weeks|This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.||percentage of participants|||Number
154412|NCT00347360|Secondary|Diastolic Responders, Defined as ≥ 10 mmHg Sitting (s)DBP Reduction From Baseline or a sDBP of <90 / 80 Millimeters (mm) of Mercury (Hg) for Non Diabetic / Diabetic Subjects Respectively (Based on Cuff Trough Measures)||Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.||participants|||Number
154413|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean Trough Sitting SBP and Sitting DBP by Cuff Assessment|Analysis of Change from Baseline to Week 6 in Mean sSBP and sDBP by Cuff Assessments at Drug Trough (20-24 hr) at End of Treatment Titration|Baseline, Week 6|ITTE with LOCF. Intent to Treat Efficacy population is defined as all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment.||mmHg||Standard Deviation|Mean
154414|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night by 24hr ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the night. The night-time assessment period started at the time of the first reading at or after 6 pm and ended immediately before 6 am on the following day.|Night BP, Baseline, Week 6|: ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
154415|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon by 24hr ABPM|Mean changes from Baseline to Week 6 in SBP and DBP measured by 24hr ABPM at the end of up-titration recorded in the afternoon. The afternoon assessment period started at or after 12 noon and ended immediately before 6 pm.|Afternoon BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
154416|NCT00347360|Secondary|Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning by 24 Hour ABPM|Mean changes from Baseline to Week 6 in DBP and SBP measured by 24hr ABPM at the end of up-titration recorded in the morning. The morning assessment period started at or after 6 am and ended immediately before 12 noon.|Morning BP, Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
154417|NCT00347360|Secondary|Overall Description of Safety in Each Treatment Group Using Adverse Events, Laboratory Evaluations, ECG Changes, Vital Sign Changes, and Withdrawal Rates.|Refer to Adverse Event section for safety information.|Weeks 1 through 48||||||
154418|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough to Peak Ratios of DBP by 24 Hour ABPM (Ambulatory Blood Pressure Monitoring)|Trough (20-24 hr) to peak (3-7 hr) ratios of DBP were examined in order to evaluate the extent to which once-daily criteria were met (ie trough:peak > 50%). Trough to peak ratios were calculated from change trough mean/change peak mean x 100.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||trough:peak ratio x 100%|||Number
154419|NCT00347360|Secondary|Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP by ABPM (Ambulatory Blood Pressure Monitoring)|Evaluation of the dose-response relationship between incremental doses of carvedilol CR and lisinopril and mean 24-hr ABPM DBP.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Error|Mean
154420|NCT00347360|Secondary|Change From Baseline to Week 6 in Trough Systolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
154452|NCT00345631|Secondary|Time to Hospital Discharge|Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge|From introducer sheath removal to patient discharge|Intent to Treat population with non-missing time data||Hour||Standard Deviation|Mean
154453|NCT00345631|Secondary|Time to Eligibility for Hospital Discharge|Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient’s physician.|From introducer sheath removal to hospital discharge, up to 284 hours|Intent to treat population with non-missing time data||Hour||Standard Deviation|Mean
154421|NCT00347360|Secondary|Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean systolic blood pressure (SBP).|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
154422|NCT00347360|Primary|Change From Baseline to Week 6 in Trough Diastolic Blood Pressure|Trough ABPM was the average across 20-24 hr after dosing for each subject.|Baseline, Week 6|ABPM Population with LOCF: This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population||mmHg||Standard Deviation|Mean
154423|NCT00347360|Primary|Change From Baseline to Week 6 in 24 Hour (hr) Mean Diastolic Blood Pressure|Ambulatory blood pressure monitoring (ABPM) was completed at Baseline and at the end of treatment/Week 6 or early withdrawal by standard electronic ABPM equipment worn by the subject for 24-hr of ambulatory activity. The 24 hr assessment period started at the time of the first reading and ended exactly 24 hr later on the following day. Data collected included mean diastolic blood pressure (DBP).|Baseline, Week 6.|ABPM Population with Last Observation Carried Forward (LOCF): This comprised all randomized subjects with efficacy (vital signs) data after a minimum of 2 weeks on treatment with valid Baseline and on-therapy ABPM measures. All efficacy data derived from ABPM assessments were summarized by this population.||mmHg||Standard Deviation|Mean
154424|NCT00347308|Primary|Eyebrow Position|Position of eyebrow at the medial canthus relative to orbital rim|At time of evaluation|||mm||Standard Deviation|Mean
154425|NCT00347022|Primary|Creatinine Clearance|The variation of creatinine clearance before and after the product injection was measured|between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration|||percent change||Standard Deviation|Mean
154426|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Per Protocol Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Per Protocol (PP) Population: all participants in the ITT Population with interpretable liver biopsies at baseline and at the 36-month follow-up visit and without major violations of the protocol||participants|||Number
154427|NCT00347009|Secondary|Number of Participants Who Were HBsAg Positive at Baseline, With HBsAg Seroconversion at Months 12, 24, and 36|HBsAg seroconversion was defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb).|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
154428|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Surface Antigen (HBsAg) Positive at Baseline and Developed Undetectable Levels of HBsAg at Months 12, 24, and 36|HBsAg positive was defined as the presence of a detectable level of HBsAg.|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
154429|NCT00347009|Secondary|Number of Participants Who Were HBeAg Positive at Baseline, With HBeAg Seroconversion at Months 12, 24, and 36|HBeAg seroconversion was defined as a decrease in HBeAg to undetectable levels and a gain of detectable levels of Hepatitis B envelope antibody (HBeAb).|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
154430|NCT00347009|Secondary|Number of Participants Who Were Hepatitis B Envelope Antigen (HBeAg) Positive at Baseline and Developed Undetectable Levels of HBeAg at Months 12, 24, and 36|HBeAg positive was defined as the presence of a detectable level of HBeAg.|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
154431|NCT00347009|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Months 12, 24, and 36|ALT levels were measured as part of the liver function tests. Participants with ALT normalization at each visit were defined as those with a value below the upper limit of the normal (ULN) range for ALT provided by that site at the respective visit.|Months 12, 24, and 36|ITT Population||participants|||Number
154432|NCT00347009|Secondary|Number of Participants With Virological Breakthrough at Months 12, 24, and 36|Virological breakthrough was defined as an increase in serum HBV DNA levels by more than 1 log10 copies/ml from treatment nadir, i.e., the lowest HBV DNA value during the study.|Months 12, 24, and 36|ITT Population||participants|||Number
154433|NCT00347009|Secondary|Number of Participants With Undetectable HBV DNA at Months 12, 24, and 36|Undetectable HBV DNA was defined as an HBV DNA level below the lower limit of detection (LLOD) of 300 copies/ml.|Months 12, 24, and 36|ITT Population||participants|||Number
154434|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^4 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^4 copies/ml.|Months 12, 24, and 36|ITT Population||participants|||Number
154435|NCT00347009|Secondary|Number of Participants Achieving Virological Response (HBV DNA Level <= 10^3 Copies/ml) at Months 12, 24, and 36|Virological response was defined as an HBV DNA level <= 10^3 copies/ml.|Months 12, 24, and 36|ITT Population||participants|||Number
154436|NCT00347009|Secondary|Change From Baseline in Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level at Months 12, 24, and 36|The levels of HBV DNA in serum were measured using the Amplicor Cobas assay by Roche Diagnostics (detection limit 300 copies/milliliter [ml]). Changes from baseline in the serum HBV DNA level at Months 12, 24 and 36 were calculated as Month 12 minus baseline, Month 24 minus baseline, and Month 36 minus baseline respectively. Change is reported in log10 units.|Baseline and Months 12, 24, and 36|ITT Population||log10 copies/ml||Standard Deviation|Mean
154478|NCT00346697|Secondary|Change in Total Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|||mg/dl||Inter-Quartile Range|Median
154479|NCT00346697|Primary|Change in Triglyceride Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|||mg/dl||Inter-Quartile Range|Median
154437|NCT00347009|Secondary|Number of Participants With a Reduction From Screening of at Least 2 Points in the Knodell Necroinflammation Score at Month 36|The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) periportal and/or bridging necrosis (scores from 0 to 10); (II) intralobular degeneration and focal necrosis (scores from 0 to 4); (III) portal inflammation (scores from 0 to 4); (IV) fibrosis (scores from 0 to 4). The Knodell necroinflammation score is the sum of scores from Parts I-III, hence a range of 0 to 18, and measures the degree of acute necroinflammatory activity in the liver.|Screening and Month 36|ITT Population||participants|||Number
154438|NCT00347009|Secondary|Number of Participants With a Reduction From Baseline in the Child-Pugh Score by 2 Points or More at Months 12, 24, and 36|The Child-Pugh score (modified version for scoring prothrombin time against reference range) was used in the study to assess the prognosis of chronic liver disease, mainly cirrhosis. The score employs five clinical measures of liver disease: encephalopathy, ascites, albumin, prothrombin time, and bilirubin. Each measure is scored on a scale of 1-3, with 1 being normal and 3 indicating most severe derangement. The total score for the Child-Pugh assessment was calculated as the sum of the 5 contributing scores, with a score range of 5 (best prognosis) to 15 (worst prognosis).|Baseline and Months 12, 24, and 36|ITT Population||participants|||Number
154439|NCT00347009|Primary|Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population)|The Ishak fibrosis score is a scoring system (ranging from 0 to 6) that measures the degree of fibrosis (scarring) of the liver, which is caused by chronic necroinflammation (an inflammatory process in the liver including or leading to death of liver cells). A score of 0 represents no fibrosis, and a score of 6 represents established cirrhosis. Participants were classified as improved if the Ishak fibrosis score at Month 36 was 1 or more points less from the Screening score.|Screening and Month 36|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication, regardless of whether the participants completed the planned duration of the study||participants|||Number
154440|NCT00345683|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154441|NCT00345683|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154442|NCT00345683|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154443|NCT00345683|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154444|NCT00345683|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits||From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154445|NCT00345683|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154446|NCT00345683|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154447|NCT00345683|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)|The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.||Subjects|||Number
154448|NCT00345631|Secondary|Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events|Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma >= 6cm; Access Site-Related Bleeding Requiring > 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse|From end of vessel closure procedure to 30 days post-procedure|Intent to treat population||Percentage of participants|||Number
154449|NCT00345631|Secondary|Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure|Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint’s closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.|From catheterization procedure to 30 day post-procedure follow up|Intent to Treat Population||Percentage of participants|||Number
154450|NCT00345631|Secondary|Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure|Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.|Within 5 minutes post-procedure|Intent to treat population (ITT) excluding the Manual Compression (MC) patients since MC Patients didn't deploy the device.||Percentage of participants|||Number
154454|NCT00345631|Primary|Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure|Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (> 30 days) access site-related nerve injury.|From post-procedure to 30 days follow up|Intent to treat population||Percentage of participants|||Number
154455|NCT00345631|Primary|Time to Ambulation (TTA)|Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.|From when the introducer sheath was removed to 30 days post-procedure|Intent to Treat (ITT)Population with non-missing time to ambulation data.||Hours||Standard Deviation|Mean
154456|NCT00345631|Primary|Time to Hemostasis (TTH)|Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.|From when the introducer sheath was removed to the time hemostasis was first observed|Intent to treat population (ITT) with non-missing time to hemostasis data. ITT population consists of all randomized (VCD and MC) patients where a femoral artery closure procedure is attempted post-randomization.||Minutes||Standard Deviation|Mean
154457|NCT00345605|Primary|Measures of Liver Function: INR|The result (in seconds) for a prothrombin time performed on a normal individual will vary according to the type of analytical system employed. This is due to the variations between different batches of manufacturer's tissue factor used in the reagent to perform the test. The INR was devised to standardize the results. Each manufacturer assigns an ISI value (International Sensitivity Index) for any tissue factor they manufacture. The ISI value indicates how a particular batch of tissue factor compares to an international reference tissue factor. The ISI is usually between 1.0 and 2.0. The INR is the ratio of a patient's prothrombin time to a normal (control) sample, raised to the power of the ISI value for the analytical system being used.|Measured after each 1-week treatment period|||seconds||Inter-Quartile Range|Mean
154458|NCT00345605|Primary|Measures of Liver Function: Coagulation Factors|Plasma levels of coagulation factors I and IX were used as measures of hepatic synthetic function since the treatment duration was short.|Measured after each 1-week treatment period|||mg/dL||Standard Deviation|Mean
154459|NCT00345605|Primary|Measures of Liver Function: PT and PTT|Prothrombin time (PT) and partial thromboplastin time (PTT) were measured PT measures factors I (fibrinogen), II (prothrombin), V, VII, and X, while PTT is a performance indicator of the efficacy of the common coagulation pathways.|Measured after each 1-week treatment period|||seconds||Inter-Quartile Range|Mean
154460|NCT00345605|Secondary|Urea Production Rate||Measured after each 1-week treatment period|||micromoles/kg/hr||Standard Deviation|Mean
154461|NCT00345605|Secondary|Arginine Levels||Measured after each 1-week treatment period|||micromoles/L||Inter-Quartile Range|Median
154462|NCT00345605|Secondary|Argininosuccinic Acid Levels||Measured after each 1-week treatment period|||micromole/l||Inter-Quartile Range|Median
154463|NCT00345605|Primary|Measures of Liver Function: AST and ALT|Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were measured.|Measured after each 1-week treatment period|||IU/L||Standard Error|Mean
154464|NCT00345592|Primary|Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation||3 years from randomization (39 months total)|||participants|||Number
154465|NCT00346697|Secondary|Change in Collagen Epinephrine From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||seconds||Inter-Quartile Range|Median
154466|NCT00346697|Secondary|Change in Collagen ADP From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||seconds||Inter-Quartile Range|Median
154467|NCT00346697|Secondary|Change in P1NP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||mcg/L||Inter-Quartile Range|Median
154468|NCT00346697|Secondary|Change in CTX Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||ng/mL||Inter-Quartile Range|Median
154469|NCT00346697|Secondary|Change in sTNFR2 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
154470|NCT00346697|Secondary|Change in sTNFR1 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
154471|NCT00346697|Secondary|Change in TNF-a Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
154472|NCT00346697|Secondary|Change in IL-6 Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||pg/mL||Inter-Quartile Range|Median
154473|NCT00346697|Secondary|Change in hsCRP Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group.||8 weeks|Analysis done on all participants with available data||ng/ml||Inter-Quartile Range|Median
154474|NCT00346697|Secondary|Change in CD4+ T-cell Counts From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data||cells/cc||Inter-Quartile Range|Median
154475|NCT00346697|Secondary|Change in HOMA-IR From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|Analysis done on all participants with available data||units on a scale||Inter-Quartile Range|Median
154476|NCT00346697|Secondary|Change in HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|||mg/dl||Inter-Quartile Range|Median
154477|NCT00346697|Secondary|Change in Non-HDL Cholesterol Concentrations From Baseline in the LOVAZA Group Compared to the Placebo Group||8 weeks|||mg/dl||Inter-Quartile Range|Median
154480|NCT00346632|Secondary|Disease Response|"Disease response (i.e., complete or partial remission) based on standard criteria:~Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649.~Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674.~VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) [updated March 2002; cited 2005 Nov 16]. Available from: http://www.pbm.va.gov/archive/imatinibcriteria.pdf"|Day 14 (Arm A) or Day 28 (Arm B) for all cycles|||number of responders|||Number
154481|NCT00346632|Secondary|Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)||Day 1 and either Day 14 or Day 28 of Cycle 1|||Ratio of hr*ng/mL||Standard Deviation|Mean
154482|NCT00346632|Secondary|Terminal Half Life (t 1/2)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||hours||Standard Deviation|Mean
154483|NCT00346632|Secondary|Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||hr*ng/mL||Standard Deviation|Mean
154484|NCT00346632|Secondary|Time to Peak Plasma Concentration (Tmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||hours||Standard Deviation|Mean
154485|NCT00346632|Secondary|Observed Peak Plasma Concentration (Cmax)||Days 1 and 14 (and Day 28 for Arm B) of Cycle 1|||ng/mL||Standard Deviation|Mean
154486|NCT00346632|Primary|Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0|In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.|Baseline up to Cycle 2, Day 1|||participants|||Number
154487|NCT00346476|Primary|Number of Participants With HIV Infection||At Year 5|||participants|||Number
154488|NCT00346476|Secondary|Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants||At Year 5||||||
154489|NCT00346476|Secondary|Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants||Year 1 to Year 5||||||
154490|NCT00346476|Secondary|Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART||Year 1 to Year 5||||||
154491|NCT00346476|Secondary|Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants||Year 1 to Year 5||||||
154492|NCT00346476|Primary|Number of Participants With Microbiologically Confirmed Tuberculosis Infection||At Year 5|||participants|||Number
154493|NCT00346398|Secondary|Time to First Onset of Asthma|Time to first onset of asthma is the time from the day a participant is randomized and initiates study treatment to the diagnosis of the first of three episodes of asthma. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze.|From Treatment Initiation to Month 36 Status Post Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial||Months||Standard Error|Mean
154494|NCT00346398|Secondary|Number of Participants With Current Asthma at Month 36 Status Post Treatment Completion|Participants who currently have asthma three years after end of treatment. Asthma is defined as three distinct episodes of wheeze after the first year of life, each of which lasts 3 or more consecutive days and occurs in a clinical setting where asthma is likely and other likely conditions have been excluded. Episodes must be separated by at least 7 days without wheeze. Current asthma is defined as a diagnosis of asthma and at least one episode of wheeze lasting 3 or more consecutive days in the past 12 months.|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial||participants|||Number
154495|NCT00346398|Primary|Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion|"Allergic sensitization is defined as a positive serum allergen specific Immunoglobulin E (IgE) CAP test[1] or a positive allergy skin prick test[2]. Not experiencing allergic sensitization is the better outcome for this measure.~A positive serum allergen specific IgE CAP (ImmunoCAP) test result is defined by a result >= 0.35 kU/L. Higher scores indicate greater allergic sensitization.~A positive skin prick test is defined as a wheal diameter that is 3 mm larger than that produced by a negative control. Higher wheal sizes indicate greater allergic reaction or sensitization."|Three years (36 months) after Treatment Completion|Intent-to-treat minus one participant in placebo group who had a sibling in trial||participants|||Number
154496|NCT00346333|Secondary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity|Annual change in number of letters read.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis and included all reliable, non-missing values. The unit of analysis was the eye.Each patient contributed 2,1, or 0 eyes with non-missing data.||Change in letters read per year||Standard Error|Mean
154497|NCT00346333|Secondary|Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.|Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;analyses of 30 Hz ERG data included those who had an initial amplitude of 0.68 microvolts or greater in at least 1 eye and data were censored when values declined to less than 0.34 microvolts. The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.||ln (microvolts)/year||Standard Error|Mean
154512|NCT00346268|Secondary|Time to Last Administration of Morphine|Time from last surgical stitch after prostatectomy to last administration of morphine (PCA and/or bolus).|baseline (end of surgery) to 48 hours post surgery|FAS; Number of participants analyzed (N)=participants with evaluable data||hours||Full Range|Median
154513|NCT00346268|Secondary|Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 48 hours after the application of the last surgical stitch after prostatectomy.|48 hours post surgery|FAS||mL||Standard Deviation|Mean
154498|NCT00346333|Secondary|Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target obtained with the 30-2 and 60-4 programs of the Humphrey Field Analyzer combined for those patients on whom both measures were available.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis. A total field was calculated for each eye using the 30-2 and 60-4 conditions after applying the eligibility criteria for each component. Total field for a given eye was not calculated if either was missing. The unit of analysis was the eye.Each patient contributed 2, 1, or 0 eyes with non-missing data.||annual change in dB vf sensitivity||Standard Error|Mean
154499|NCT00346333|Secondary|Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.|Sum of visual field sensitivity readings in dB to a size V target from the 30 degree meridian to the 60 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|This was an intention to treat analysis;lower sample sizes for this endpoint reflect instances where test results were not available for this outcome variable.The ability to perform this test was not a criterion for study entry.Eyes with an initial score ≥ 10 were included. Values were set to zero for all visits after an initial value of zero.||annual change in dB vf sensitivity||Standard Error|Mean
154500|NCT00346333|Primary|Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).|Sum of visual field sensitivity readings in decibel(dB) to a size V target out to the 30 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.|assessed at each of 4 annual visits after baseline|Intention to treat analysis;sample of 215 patients with all 4 years of followup and reliable, non missing data at all 4 years was analyzed. Eyes with an initial 30-2 total point score >= 250 dB were included.The eye was the unit of analysis. Each patient contributed 2,1, or 0 eyes with non-missing data.||annual change in db vf sensitivity||Standard Error|Mean
154501|NCT00346268|Other Pre-specified|Total Amount of Postoperative Drainage Fluid|After removal of the prostate and placement of the urine catheter, at least one easy-flow drainage was placed in the perivesical space. Drainage fluid (a mixture with a variable combination of blood and urine) was measured.|24 hours post surgery|Data not analyzed due to study termination.||mL|||Number
154502|NCT00346268|Other Pre-specified|Hemoglobin Concentration||24 hours post surgery|Data not analyzed due to study termination.||g/dL|||Number
154503|NCT00346268|Other Pre-specified|Overall Analgesic Benefit Score (OABS)|Participants' rating of global assessment of analgesic experience. OABS comprised of scores for symptoms (vomiting, itching, sweating, freezing, and dizziness) and patient satisfaction; Participants asked how much did symptoms distress and bother them during the last 24 hours; Participants asked how satisfied they have been with treatment of pain during last 24 hours. Each symptom and satisfaction question scored from 0 (not at all) to 4 (very much so). Total possible score=0 to 24.|24 and 48 hours post surgery|Data not analyzed due to study termination.||scores on a scale|||Number
154504|NCT00346268|Other Pre-specified|Number of Participants With Health Care Resource Utilization (HCRU)|"Supervising physician or nurse answered question in the presence of participant, In the last 24 hours, did the participant receive any unscheduled consultation from any of the following specialist: anesthesiologist, surgeon, nurse or other specialist."|24 and 48 hours post surgery|Data not analyzed due to study termination.||participants|||Number
154505|NCT00346268|Other Pre-specified|Number of Participants With Rating of Global Evaluation of Study Medication|"Participants asked, “How would you rate the study medication you received for pain since your surgery? choices included: Poor, Fair, Good, and Excellent."|48 hours post surgery|FAS; N=participants with evaluable data.||participants|||Number
154506|NCT00346268|Secondary|Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score|Participant-rated scale assessed 10 common opiate related symptoms by 3 ordinal measures: frequency (1 to 4 scale: rarely to almost constantly), severity (1 to 4 scale: slight to very severe) and bothersomeness (1 to 5 scale: not at all to very much). Frequency and severity items assigned numeric scores 1 to 4. Bothersomeness items scaled in order to assign numeric scores 0.8 to 4.0 (not at all scored=0.8, a little bit=1.6, somewhat=2.4, quite a bit=3.2, and very much=4.0). Overall composite score=mean of each 10 individual mean symptoms’ OR-SDS scores; ranged from 1 to 4.|24 and 48 hours post surgery|FAS; N=participants with evaluable data.||scores on scale||Standard Deviation|Mean
154507|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, coughing, deep breathing, and concentration) in past 24 hours.|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable data for specified category; for analyses, missing values imputed using LOCF method.||scores on a scale||Standard Deviation|Mean
154508|NCT00346268|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score|mBPI-sf: participant-rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Pain severity index=the mean of item scores 2 to 5 (pain at its worst in past 24 hours, pain at its least in past 24 hours, average pain level, and pain right now).|24 and 48 hours post surgery|FAS; N=participants with evaluable data; n=participants with evaluable for specified category; for analyses, missing values imputed using Last-Observation-Carried-Forward (LOCF) method.||scores on a scale||Standard Deviation|Mean
154509|NCT00346268|Secondary|Pain Intensity Score|"Pain intensity assessed immediately prior and 30 minutes after administration (admin) of study medication, participants categorized their pain intensity at rest and at movement on 0-4 numeric rating scale (NRS):0 (minimum intensity) to 4 (maximum intensity).~Movement defined as sitting up from a lying into a sitting position in bed."|12, 24, 36, and 48 hours post surgery|FAS; N=participants with evaluable data||scores on a scale||Standard Deviation|Mean
154510|NCT00346268|Secondary|Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units||48 hours post surgery|FAS||participants|||Number
154511|NCT00346268|Secondary|Amount of Blood Loss|Calculated as: ([Hb g/dL]pra + RBCUduring48)-[Hb g/dL]at 48, where [Hb g/dL]pra=blood hemoglobin concentration preoperatively in grams per deciliter (g/dL), [Hb g/dL]at 48=blood hemoglobin concentration 48 hours after skin closure, and RBCUduring48=number of red blood cell units (RBCU) substituted during and after prostatectomy until 48 hours after skin closure.|48 hours post surgery|FAS||g/dL||Standard Deviation|Mean
154514|NCT00346268|Primary|Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery|Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.|24 hours post surgery|Full Analysis Set Population (FAS): participants who were randomized to treatment||mL||Standard Deviation|Mean
154515|NCT00346151|Secondary|Proportion of Participants With Post-transplant Diabetes Mellitus||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
154516|NCT00346151|Secondary|Proportion of Participants With Delayed Graft Function||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
154517|NCT00346151|Secondary|Proportion of Participants With Chronic Allograft Nephropathy||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
154518|NCT00346151|Secondary|Proportion of Participants With a Sirolimus Associated Adverse Event||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
154519|NCT00346151|Secondary|Proportion of Participants With Malignancies||Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
154520|NCT00346151|Secondary|Proportion of Participants With Wound Complications||Start of study to end of study|Intent to Treat Sample||Participants|||Number
154521|NCT00346151|Secondary|Proportion of Participants With Post-transplant Infections|Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
154522|NCT00346151|Secondary|Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection|"Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|Participants followed from transplantation until completion of study (up to four years post-transplantation)|Intent to Treat Sample||Participants|||Number
154523|NCT00346151|Secondary|Time From Transplant to Acute Rejection|"Time (days) from transplant to occurrence of acute rejection[1]~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|Transplantation until rejection occurs (participants followed up to four years post-transplantation)|Intent to treat sample participants with rejection||Days||Full Range|Median
154524|NCT00346151|Secondary|Graft Survival at 12 Months Post-transplant||12 months post-transplant|Intent to treat sample participants not terminating prior to 12 months||Participants|||Number
154525|NCT00346151|Secondary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks|"GFR utilizing clearance of iothalamate.~GFR is an index of level of kidney function. A higher value means better kidney function."|24 weeks post-transplant|Intent to Treat Sample||mL/min/1.73m^2||Standard Deviation|Mean
154526|NCT00346151|Secondary|Tolerance Induction|Time from transplantation to initiation of sirolimus withdrawal.|48 months|Intent to treat sample that initiated sirolimus withdrawal||Days|||Number
154527|NCT00346151|Secondary|Acute Rejection at 12-Months|"Incidence of acute rejection[1] at 12 months post-transplant~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|12 months post-transplant|Intent to Treat Sample||Participants|||Number
154528|NCT00346151|Secondary|Participant Survival at 12 Months Post-Transplant||12 months post-transplant|Intent to Treat Sample participants not terminating prior to 12 months.||Participants|||Number
154529|NCT00346151|Primary|Acute Rejection at 6-Months|"Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads~Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999"|6 months post-transplant|Intent to Treat||Participants|||Number
154530|NCT00346034|Primary|Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score|Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 “no pain” to 100 “worst possible pain”. Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.|Week 12 (end of treatment)|This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.||mm||Standard Deviation|Mean
154531|NCT00346034|Primary|Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score|Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 “no pain” to 100 “worst possible pain”. Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.|Week 4|This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.||mm||Standard Deviation|Mean
154566|NCT00345176|Other Pre-specified|Genetics for the Progression of AMD and Cataract||5 years of follow-up||||||
154532|NCT00345878|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)|||Subjects|||Number
154533|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|"NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes, allergies,...~Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or SAEs that are not related to common diseases."|Throughout the study period (up to Month 7)|||Subjects|||Number
154534|NCT00345878|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days after any vaccination|||Subjects|||Number
154535|NCT00345878|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days after each vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
154536|NCT00345878|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Month 0 and Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
154537|NCT00345878|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
154538|NCT00345839|Secondary|Time to Parathyroidectomy|Time to Parathyroidectomy. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154539|NCT00345839|Secondary|Time to Bone Fracture|Time to Bone Fracture. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154540|NCT00345839|Secondary|Time to Stroke|Time to Stroke. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154541|NCT00345839|Secondary|Time to Cardiovascular Mortality|Time to Cardiovascular Mortality. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154542|NCT00345839|Secondary|Time to Peripheral Vascular Event|Time to Peripheral Vascular Event. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154543|NCT00345839|Secondary|Time to Heart Failure|Time to Heart Failure. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154544|NCT00345839|Secondary|Time to Hospitalization for Unstable Angina|Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154545|NCT00345839|Secondary|Time to Myocardial Infarction|Time to Myocardial Infarction. Stratified by history of diabetes and country.|From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154546|NCT00345839|Secondary|Time to All-cause Mortality|Time to All-cause Mortality. Stratified by history of diabetes and country.|From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154567|NCT00345176|Other Pre-specified|Genetics for the Association of AMD and Cataract||5 years of follow-up||||||
154568|NCT00345176|Other Pre-specified|Prevalence of Peripheral Changes as Measured Using OPTOS Imaging|Effects of oral supplementation of omega-3 fatty acids, lutein/zeaxanthin on the peripheral retina|5 years of follow-up||||||
154547|NCT00345839|Primary|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)|Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.|From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years|Utilizes the Efficacy Analysis Set which includes all randomized participants. Participants were analyzed in the treatment group as randomized using the Intent-to-treat (ITT) method.||Months||Inter-Quartile Range|Median
154548|NCT00345579|Primary|Number of Subjects With Adverse Events Resulting in Emergency Room (ER)||From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154549|NCT00345579|Primary|Number of Subjects With Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154550|NCT00345579|Primary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154551|NCT00345579|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154552|NCT00345579|Primary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)||From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154553|NCT00345579|Primary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154554|NCT00345579|Primary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154555|NCT00345579|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)|The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.||Subjects|||Number
154556|NCT00345540|Secondary|Progression Free Survival (PFS)||From time of treatment start to time of disease progression|||Weeks||Full Range|Mean
154557|NCT00345540|Secondary|Safety of NOV-002 and Carboplatin||Duration of trial and through 30-day follow-up period after final treatment|||Adverse Events|||Number
154558|NCT00345540|Primary|Response Rate||At treatment completion (8 weeks) and monthly until disease progression|||Participants|||Number
154559|NCT00345397|Primary|Change in Bowel QoL|"Spinal Cord Injury (SCI) -Specific, 20-Question QoL Instrument used a Visual Analog Scale (VAS) for each item.~These were scored by measurement and recording 1-10 along the scale (1 being best, 10 being worst) An average of the scores for the 20-items was calculated for each subject before and after Percutaneous Endoscopic Colostomy (PEC) Tube placement.~A Global SCI-QoL Score was also recorded using the same VAS. The difference between these Intake and Exit scores was used to define change in SCI-Specific Quality of Life."|Exit data collected 1 year(+/- 6 mo) after Intake data collection / PEC placement|Subjects completing both Intake and Exit assessments||units on a scale||Standard Deviation|Mean
154560|NCT00345384|Secondary|Measure the Amount of Respiratory Depression in Each Groups|Respiratory depression and deep levels of sedation can occur when morphine patient-controlled analgesia is prescribed for postoperative patients. In this secondary outcome measure, it was hypothesized that the addition of a dexmedetomidine infusion to the postoperative pain management protocol would reduce the amount of morphine delivered by a PCA pump while providing adequate analgesia. Data are reported for the time period 6 to 16 hours. However, the subjects were on the study for an average of 24 hours, up to 30 hours.|Hours 6 to 16|||mmHg||Standard Deviation|Mean
154561|NCT00345384|Primary|Measure Any Reduction in the Amount of Opioid Administered to Patients in the Dexmedetomidine Study Arm.|To measure the amount of opioid use requested by patients enrolled in the dexmedetomidine study arm during the observation period of 24 hours, up to 30 hours per patient.|An average of 24 hours, up to 30 hours per patient|Participants completing the study were analyzed as per protocol||IV morphine equivalency in mg||95% Confidence Interval|Number
154562|NCT00345293|Secondary|Clinical Response||Post treatment|This data was not collected due to differences in immunogenicity based on different dendritic cell preparations. This data was no longer relevant.|||||
154563|NCT00345293|Secondary|Immunogenicity|The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).|pre and post treatment|One other participant in DC/PC3 vaccine-Selected group not analyzed due to failed controls in assay.||counts per minute||Full Range|Median
154564|NCT00345293|Primary|Toxicity|adverse events|through week 29|||events|||Number
154565|NCT00345254|Primary|Umbilical Artery pH||immediately after delivery|||units on a scale||Standard Deviation|Mean
154571|NCT00345176|Secondary|Progression to Cataract Surgery|The study examined the effects of lutein/zeaxanthin on progression to cataract surgery with data collected during regular telephone contacts and the annual study visits.|5 years of follow-up|Includes participants who were phakic in at least 1 eye at baseline||Eyes|Participants||Number
154572|NCT00345176|Secondary|Adverse Events|Safety outcomes included serious adverse events and mortality.|5 years of follow-up|Number of deaths in 5 years||Participants|||Number
154573|NCT00345176|Secondary|Progression to Moderate Vision Loss|Loss defined as >/= 3 lines of letters from baseline or treatment for choroidal neovascularization|5 years of follow-up|||Eyes|Participants||Number
154574|NCT00345176|Primary|Development of Advanced AMD in People at Moderate to High Risk for Progression.|Defined as central geographic atrophy or retinal features of choroidal neovascularization detected on central grading of the stereoscopic fundus photographs or a history of treatment for advanced AMD after study enrollment.|5 years of follow-up|Intention to Treat. Participants lost to follow-up during the course of the study were censored at the time of last contact.||Eyes|Participants||Number
154575|NCT00345046|Primary|Percent Change in Flare at Resolution||2 months|||Percent change in flare||Standard Deviation|Mean
154576|NCT00345033|Primary|Change in Insulin Resistance|A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)||HOMA score||Standard Deviation|Mean
154577|NCT00345033|Primary|Change in Triglycerides||Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30)||mg/dL||Standard Deviation|Mean
154578|NCT00345033|Primary|Change in Glucose Metabolism|A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).||min^-1||Standard Deviation|Mean
154579|NCT00345033|Primary|Change in Body Mass Index (BMI)|A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).||kg/m^2||Standard Deviation|Mean
154580|NCT00345033|Primary|Change in Weight|A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N=30).||kg||Standard Deviation|Mean
154581|NCT00345033|Primary|Change in Total Cholesterol|A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.|Measured at Baseline and Week 8|The number of participants for analysis (intent to treat) were those that completed the study (N = 30).||mg/dL||Standard Deviation|Mean
154582|NCT00344968|Secondary|Retinal Thickness|Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.|36 months|||microns||Standard Deviation|Mean
154583|NCT00344968|Primary|Visual Acuity|The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).|36 months|Three subjects were randomized but did not receive treatment. These subjects were not included in the safety analysis, which accounts for the discrepancy in the overall number of participants.||percentage of subjects|||Number
154584|NCT00344773|Secondary|Safety Profile: Participants With Adverse Events|Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.|baseline to end of study||||||
154585|NCT00344773|Secondary|Overall Survival (OS)|Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.|baseline to 12 months|||Percent of Participants|||Number
154586|NCT00344773|Secondary|Progression Free Survival (PFS)|Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.|baseline to 4 months|||Percent of Participants|||Number
154587|NCT00344773|Primary|Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|"Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.~RECIST criteria:~CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria"|baseline to 12 months|||Percent of Participants|||Number
154588|NCT00344682|Secondary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6 on 10 items. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in response rate and remission rate were assessed for secondary measures.|baseline and week 8|Secondary outcome examines a change in response rates,when 50% change from baseline, & remission rates, when MADRS scores of 12 or less were observed.Fischer exact tests assessed efficiency in each treatment group. Intent-to-treat rates at baseline minus week 8 through last observed data carried forward (LOCF) were used;no data values were imputed||units on a scale||Standard Deviation|Mean
154589|NCT00344682|Secondary|Hamilton Anxiety Rating Scale (HARS)|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Scores > 30 indicate severe anxiety.|baseline & week 8|Secondary outcome examines a change in mean HARS scores observed at baseline & week 8 through last observed data carried forward (LOCF);no values were imputed for missing assessments.Efficacy data analysis used intent-to-treat measures & computes final study score minus baseline averaged among participants to evaluate treatment group differences||units on a scale||Standard Deviation|Mean
154693|NCT00343083|Primary|The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy.|The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.|3 months|||participants|||Number
154590|NCT00344682|Secondary|Modified Quick Inventory of Depressive Symptoms Self Report Scale (QIDS-SR)|The 16 item Quick Inventory of Depressive Symptomatology (QIDS-SR16) (Rush et al. 2003) is designed to assess the severity of depressive symptoms, with higher scores representing more severe forms of depression. When complete, the QIDS are scored by summing responses to obtain a total score ranging from 0 to 27. Either appetite increase or decrease, but not both, are used to calculate the total score. Weight increase or decrease, but not both, are used to calculate the total score. Scores 0-5 indicate no severity of depression; 6-10 is mild; 11-15 is moderate; 16-20 is severe; 21-27 is very severe levels of depression. Participants were evaluated at baseline and at weeks 1, 2, 3, 4, 6 & 8.|baseline & week 8|The secondary outcome examines a change over in mean QID-SR scores at baseline & week 8 through last observed data carried forward (LOCF); no values were imputed for missing assessments. Data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.||units on a scale||Standard Deviation|Mean
154591|NCT00344682|Primary|Montgomery-Asberg Depression Rating Score (MADRS)|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Scores 0 to 6 indicate symptoms absent; 7 to 19 indicates mild depression; 30 to 34 defines moderate; 35 to 60 indicates severe depression. Changes in MADRS score was a primary measure.|Baseline & week 8|The primary outcome examines a mean change in MADRS scores at baseline & week 8 through last observation carried forward (LOCF); no values were imputed for missing assessments. The primary data analysis used intent-to-treat measures and computes final study score minus baseline averaged among participants to evaluate treatment group differences.||units on a scale||Standard Deviation|Mean
154592|NCT00344500|Primary|Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis|Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months|||Body Fat Percentage Change|||Number
154593|NCT00344500|Primary|Change in Predicted Trajectory of Mean BMI Per GLMM Analysis|General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.|12 months|||kg/m^2|||Number
154594|NCT00344500|Primary|Mean Weight|Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.|Weekly/Monthly, up to 1 year|All subjects who enrolled in this research program. Subjects were assessed weekly, when able. Since some were not able to do every weekly assessment, N varies weekly, and the weekly assessments below are the means of the number of subjects out of the total in the group who were assessed at that point.||Pounds||Standard Deviation|Mean
154595|NCT00344487|Primary|Changes in the Slope of CD4 as Assessed 6 Months Prior to the Lopinavir/Ritonavir Switch (Baseline), Compared to 6-12 Month Intervals Post Initiation of Lopinavir/Ritonavir (Slope 1-6 Months, 1-12 Months)||6 and 12 months||||||
154596|NCT00344487|Primary|Baseline Will be Defined as the Mean of 2 Values Obtained Prior to the Medication Switch (for Analysis Purposes, the CD4 Cell Counts at 6 and 12 Months Will be Defined by the Mean of the CD4 Cell Counts Obtained at Months 3, 6 or 9, 12, Respectively).||3, 6, 0r 9, 12 months respectively||||||
154597|NCT00344487|Primary|Changes From Baseline in CD4 Cell Count at 6 and 12 Months||6 and 12 months||||||
154598|NCT00344487|Primary|Changes From Baseline in CD4 Cell Percentage at 6 and 12 Months||Baseline, 6 and 12 months|||Percentage of Cells||Standard Deviation|Mean
154599|NCT00344487|Primary|Absolute Change in CD4 Cell Count From Baseline, and at 6 and 12 Months||6 and 12 months||||||
154600|NCT00344448|Primary|Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks|"Patient will be considered a responder if (s)he demonstrates improvement in 2 / 3 disease activity measures without worsening of the third one.~Salivary flow: 0.45 ml / 15 min improvement in unstimulated whole salivary flow from baseline value obtained at the study entry.~Salivary gland biopsy:~at least 2 points improvement in the focus score on MSG biopsy~Tear flow:~at least 30% improvement in ophthalmic Oxford grading scheme or normalization of the scale as defined by score of 0 or 2mm improvement in Schirmer test as compared with the baseline in either eye."|3 months|||participant|||Number
154601|NCT00344370|Secondary|Percent Change From Baseline in LDL-C|Percent change from baseline in LDL-C at 44 weeks|Basseline to 44 weeks|||percent change||Standard Deviation|Mean
154602|NCT00344370|Primary|NCEP LDL-C Target Attainment|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study.|44 weeks|The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment||Participants|||Number
154603|NCT00344305|Secondary|Number of Subjects Reporting REs in Relation to Any Vaccine Virus Shedding|The REs for this study included: fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain, muscle ache, chills, decreased activity level, decreased appetite, and irritability.|Days 0-28 after study vaccination|Subjects who had REs and were in the shedding population.||participants|||Number
154694|NCT00343044|Secondary|Number or Participants With Toxicity||measured at each treatment cycle|||participants|||Number
154605|NCT00344305|Secondary|Number of Subjects Reporting Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination|Reactogenicity events were predifined solicited events that could potentially occure after vaccination. The REs for this study included: fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain, muscle ache, chills, decreased activity level, decreased appetite, and irritability.|Days 0-28 after vaccination|Safety population||participants|||Number
154606|NCT00344305|Secondary|Genotypic and Phenotypic Stability of B Shed Vaccine Virus|Laboratory phenotypic and genotypic data were summarized by treatment and age group for subjects who shed vaccine virus.|Days 1-28 after study vaccination|The shedding population included subjects who received a full dose of investigational product and who had valid assay results from nasal specimens obtained at any post-dosing time point were evaluable for shedding.||samples|Participants||Number
154607|NCT00344305|Secondary|Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus|Laboratory phenotypic and genotypic data were summarized by treatment and age group for subjects who shed vaccine virus.|Days 1-28 after study vaccination|The shedding population included subjects who received a full dose of investigational product and who had valid assay results from nasal specimens obtained at any post-dosing time point were evaluable for shedding.||samples|Participants||Number
154608|NCT00344305|Secondary|Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus|Laboratory phenotypic and genotypic data were summarized by treatment and age group for subjects who shed vaccine virus.|Days 1-28 after study vaccination|The shedding population included subjects who received a full dose of investigational product and who had valid assay results from nasal specimens obtained at any post-dosing time point were evaluable for shedding.||samples|Participants||Number
154609|NCT00344305|Secondary|Quantitation of Confirmed B Shed Vaccine Virus on Any Day|This was evaluated using log (TCID50) for each virus strain and summarized for all subjects who shed vaccine virus and by age group.|Days 1-28 after study vaccination|Shedding population of subjects who actually shed a confirmed strain. In addition, one subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||log (TCID50) per mL||Standard Deviation|Mean
154610|NCT00344305|Secondary|Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day|This was evaluated using log (TCID50) for each virus strain and summarized for all subjects who shed vaccine virus and by age group.|Days 1-28 after study vaccination|Shedding population of subjects who actually shed a confirmed strain. In addition, one subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||log (TCID50) per mL||Standard Deviation|Mean
154611|NCT00344305|Secondary|Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day|This was evaluated using log transformed mean tissue culture infective dose (TCID50) for each virus strain (maximum viral quantification per strain per subject) and summarized for all subjects who shed vaccine virus and by age group.|Days 1-28 after study vaccination|Shedding population of subjects who actually shed a confirmed strain. In addition, one subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||log (TCID50) per mL||Standard Deviation|Mean
154612|NCT00344305|Secondary|Duration of Confirmed Vaccine B Virus Shedding|The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.|Days 1-28 after study vaccination|Shedding population of subjects who actually shed a confirmed strain. In addition, one subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||Number of days||Standard Deviation|Mean
154613|NCT00344305|Secondary|Duration of Confirmed Vaccine A/H3N2 Virus Shedding|The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.|Days 1-28 after study vaccination|Shedding population of subjects who actually shed a confirmed strain. In addition, one subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||Number of days||Standard Deviation|Mean
154614|NCT00344305|Secondary|Duration of Confirmed Vaccine A/H1N1 Virus Shedding|The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.|Days 1-28 after study vaccination|Shedding population of subjects who actually shed a confirmed strain. In addition, one subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||Number of days||Standard Deviation|Mean
154615|NCT00344305|Secondary|Duration of Any Vaccine Virus Shedding|The number of days of shedding was summarized for all subjects who shed vaccine virus and by age group.|Days 1-28 after study vaccination|Shedding population of subjects who actually shed any vaccine virus. In addition, one subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||Number of days||Standard Deviation|Mean
154616|NCT00344305|Primary|Number of Subjects Who Shed Vaccine Virus (Virus in the Nose of the Recipient That Was Recovered and Cultured From Respiratory Secretions Following Vaccination)|Subjects were evaluated for viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 [B/Shanghai/361/2002-like]) by collection of nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Subjects whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.|Day 1-28 after study vaccination|Shedding population. One subject was excluded because of receipt of HBV vaccination 3 days prior to study entry.||participants|||Number
154617|NCT00344175|Secondary|Percent Change From Baseline in LDL-C||Baseline to 44 weeks|||percent change||Standard Deviation|Mean
154618|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 44|Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.|44 Weeks|||Participants|||Number
154619|NCT00344175|Primary|Number of Patients Attaining NCEP LDL-C Target at Week 16|Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.|16 weeks|All patients who received at least 1 dose of study drug and who had at least 1 on-treatment (post Visit 1) lipid assessment.||particpants|||Number
154620|NCT00344032|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events assessed include medical occurrences that results in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 7)|||Subjects|||Number
154695|NCT00343044|Secondary|Objective Response Rate|RECIST criteria|Response|||participants|||Number
154621|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.|Throughout the study period (up to Month 7)|||Subjects|||Number
154622|NCT00344032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 30 days (Days 0 - 29) after each vaccination|||Subjects|||Number
154623|NCT00344032|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.|During the 7 days (Days 0 - 6) after each vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
154624|NCT00344032|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0 and 7|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||EL.U/mL||95% Confidence Interval|Geometric Mean
154625|NCT00344032|Primary|Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|At Month 7|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity.||Subjects|||Number
154626|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|At Month 30, Month 42, Month 54 & Month 66|LT total cohort included all subjects who were included in the total cohort in the primary study and returned at the considered follow-up time point.||Participants|||Number
154627|NCT00343915|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Month 0 to Month 66)|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group.||Subjects|||Number
154628|NCT00343915|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-30) follow-up period after each vaccination and overall|Total Cohort included all enrolled (i.e. randomized or vaccinated) subjects who received at least one vaccine dose and for whom data were available. No information regarding AEs was available for 1 subject in each group||Subjects|||Number
154629|NCT00343915|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.||Subjects|||Number
154630|NCT00343915|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0-3) follow-up period after each vaccination and overall|The ATP cohort for safety included all evaluable subjects, who received at least one dose of study vaccine according to their random assignment, with sufficient data to perform safety analysis, who did not receive a vaccine not specified or forbidden in the protocol.||Subjects|||Number
154631|NCT00343915|Secondary|Number of Subjects Seroprotected for Anti-HBs Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Months 1, 2 and 6|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||Subjects|||Number
154632|NCT00343915|Secondary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Months 1, 2, 6 and 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||mIU/mL||95% Confidence Interval|Geometric Mean
154633|NCT00343915|Primary|Antibody Titers Against Hepatitis-B Virus.|Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.||mIU/mL||95% Confidence Interval|Geometric Mean
154634|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 30, Month 42, Month 54 and Month 66|Long Term According-to-Protocol cohort for immunogenicity, including all subjects who returned at the considered follow-up time point and who complied with the protocol.||Subjects|||Number
154635|NCT00343915|Primary|Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 7|The ATP cohort for immunogenicity included all evaluable subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.||Subjects|||Number
154636|NCT00343889|Secondary|Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.~Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable."|Day 0 up to Day 7 after each vaccination|Safety was assessed on the safety analysis (intent-to-treat) population.||Participants|||Number
154637|NCT00343889|Secondary|Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA).~Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination."|1 month post third vaccination|Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population.||Participants|||Number
154638|NCT00343889|Secondary|Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies.~Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.||Participants|||Number
154639|NCT00343889|Secondary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV|Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).|1 month post third vaccination|Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.||Titers||95% Confidence Interval|Geometric Mean
154640|NCT00343889|Primary|Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.~Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Seroprotection to hepatitis H Antigen was assessed in the per-protocol population.||Participants|||Number
154641|NCT00343889|Secondary|Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV|"Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies.~Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination."|1 month post third vaccination|Anti-Hepatitis B Responses was assessed in the per-protocol population.||Participants|||Number
154642|NCT00343564|Secondary|Phase 1: Pharmacokinetics of SB-743921 Administered on a Days 1 and 15 of a 28 Day Cycle.||28 days||||||
154643|NCT00343564|Primary|Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.|Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).|28 days|Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations.||mg/m2|||Number
154644|NCT00343512|Secondary|Tumor Response as Measured by Ultrasound|Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|At screening, 8 weeks and at surgery (within 14-21 days)|||participants|||Number
154645|NCT00343512|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria|Through 30 days after completion of treatment|||participants|||Number
154646|NCT00343512|Primary|Number Participants to Achieve Pathologic Complete Response|whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)|3 month|||participants|||Number
154647|NCT00343460|Secondary|Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1|Subject who were very satisfied on Day 1|0- 24 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
154648|NCT00343460|Secondary|Quality of Life and the Impact of Nausea and Vomiting on Day 5|Functional Living Index|5 days|Cycle 1 - Modified Intent-to-Treat Population (All Languages Except Punjabi)||participants|||Number
154649|NCT00343460|Secondary|Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses|"Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles~Complete Response is defined as no emetic episodes and no use of rescue medications"|0-120 Hours|Number of subjects in the Modified Intent-to-Treat Population with overall CR (0-120 hrs) in all cycles||participants with overall CR|||Number
154650|NCT00343460|Secondary|Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)|Maximum severity of nausea, days 1-5|0-120 Hours|Severity of Nausea - Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
154651|NCT00343460|Secondary|First and Overall Use of Rescue Medication||0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
154652|NCT00343460|Secondary|Time to First Treatment Failure|Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration|0-120 Hours|Proportions of subjects event free in Cycle 1 - Modified Intent-to-Treat Population||Proportion of subjects event free|||Number
154653|NCT00343460|Secondary|Number of Emetic Episodes|Number of Emetic Episodes - days 1-5|Days 1-5|Cycle 1 - Modified Intent-to-Treat Population||Number of Emetic Episodes||Standard Deviation|Mean
154654|NCT00343460|Secondary|Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1|"TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.~TR during delayed-onset phase is defined as Complete Response with no nausea during >24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1."|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
154655|NCT00343460|Secondary|Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1|Complete control is defined as complete response with no more than mild nausea.|0-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
154656|NCT00343460|Primary|Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|24-120 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
154657|NCT00343460|Primary|Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1|Complete Response is defined as no emetic episodes and no use of rescue medications|0-24 Hours|Cycle 1 - Modified Intent-to-Treat Population||participants|||Number
154658|NCT00343382|Secondary|Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.|Baseline and Week 6|Includes all participants who completed both baseline and week 6 assessments.||units on a scale||Standard Deviation|Mean
154659|NCT00343382|Secondary|Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living|The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).||units on a scale||Standard Deviation|Mean
154660|NCT00343382|Secondary|Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|End of 6 weeks|||participants|||Number
154661|NCT00343382|Primary|Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics|Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.|Baseline to Week 6|Includes all participants that reported a baseline value and at least one value after baseline (i.e. week 3, 4, 5 or 6).||units on a scale||Standard Deviation|Mean
154662|NCT00343291|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rate)|Functional Assessment of Cancer Therapy for Patients With Lung Cancer (FACT-L) measures domains of health-related quality of life (HR-QL): physical wellbeing (WB), social/family WB, emotional WB, functional WB, and additional lung cancer concerns. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item Lung cancer subscale (LCS) score maintained for 2 consecutive assessments. Scores range from 0-28 with higher scores indicating fewer symptoms. Patients with a score of >26 were not evaluable for symptom response, since a score of 28 is the maximum possible.|From date of partial response until progression of disease up to 31.8 months|Included all enrolled, randomized participants with a score of ≤26 at baseline. All participants were analyzed as part of the treatment group to which they were randomized.||percentage of participants||95% Confidence Interval|Number
154696|NCT00343044|Secondary|Evaluation of Overall Survival|Overall survival was defined as the number of months after commencing study treatment to death.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|The planned enrollment of 40 participants was determined using a median PFS of 9 months (based on a median PFS of 7.2 months in a previous trial).||months||95% Confidence Interval|Median
154663|NCT00343291|Secondary|Duration of Overall Response|The duration of response, in participants with best overall response of CR or PR, is measured from the date criteria are met for CR/PR (whichever is first recorded), until the first date that the criteria for PD is met or death. CR, PR, and PD, as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions; PD≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Time of first response to the first date of PD or death due to any cause up to 31.8 months|Included all enrolled, randomized participants with a best overall response of CR or PR (responders). All participants were analyzed as part of the treatment group to which they were randomized.||months||95% Confidence Interval|Median
154664|NCT00343291|Secondary|Percentage of Participants Achieving an Objective Overall Response (Overall Response Rate)|The best objective overall response rate (ORR) is the percentage of randomized participants with a best overall response of complete response (CR) or partial response (PR), as classified by the investigator according to the RECIST guidelines. CR=disappearance of all target lesions; PR≥30% decrease in sum of longest diameter of target lesions. ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated in that arm, multiplied by 100. Participants with no post-baseline evaluation will be considered as a non-responder.|Randomization to measured progressive disease up to 31.8 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.||percentage of participants||95% Confidence Interval|Number
154665|NCT00343291|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death. Participants who are alive will be censored on the last known alive date.|Randomization to the date of death from any cause up to 42.7 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.||months||95% Confidence Interval|Median
154666|NCT00343291|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD ≥20% increase in sum of longest diameter of target lesions. Participants who are alive and without PD will be censored at the date of their last tumor assessment.|Randomization to PD or date of death from any cause up to 33.1 months|Included all enrolled, randomized participants. All participants were analyzed as part of the treatment group to which they were randomized.||months||95% Confidence Interval|Median
154667|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.||units on a scale||Standard Error|Least Squares Mean
154668|NCT00343252|Secondary|Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.|Baseline, 18 Months|Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.||units on a scale||Standard Error|Least Squares Mean
154669|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Baseline through 18 Months|Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.||participants|||Number
154670|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Baseline through 18 Months|Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.||participants|||Number
154671|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.||participants|||Number
154721|NCT00340704|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
154672|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.|18 Months|Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.||participants|||Number
154673|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 18 Months|Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 18 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.||participants|||Number
154674|NCT00343252|Secondary|Number of Participants With Adverse Events (Safety) During 12 Months|Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.|Baseline through 12 Months|Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.||participants|||Number
154675|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
154676|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
154677|NCT00343252|Secondary|Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
154678|NCT00343252|Secondary|Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
154679|NCT00343252|Secondary|Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.|Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).|Baseline, 3 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||units on a scale||Standard Error|Least Squares Mean
154680|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.||participants|||Number
154723|NCT00340704|Secondary|Cmax, 1 ,DW ,Norm|Dose- and weight-normalized Cmax,1 (Cmax,1,DW,norm). Weight normalization of Cmax,1 was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
154681|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months|Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.||participants|||Number
154682|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.||participants|||Number
154683|NCT00343252|Secondary|Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months|Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.|Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.||participants|||Number
154684|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
154685|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint|24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
154686|NCT00343252|Secondary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.|12 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
154687|NCT00343252|Primary|Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint|24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.|6 Months|Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.||participants|||Number
154688|NCT00343083|Secondary|Clinical Complete Response Rate of This Regimen in the Population|What is the the complete response (CR) rate at the completion of therapy.|3 months|||percentage of participants|||Number
154689|NCT00343083|Secondary|Percentage of Participants With Grade 3 Toxicities of Cetuximab|"One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible.~Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity."|9 weeks|||percentage of participants|||Number
154697|NCT00343044|Primary|Progression Free Survival|Progression free survival(PFS)was measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with measurable disease. For patients with nonmeasurable disease, cancer antigen (CA-125) levels were used to determine response according to Rustin criteria. Progression-free survival was defined as number of months after beginning study treatment until progressive disease or death, respectively.|PFS and OS were defined as the number of months after commencing study treatment until progressive disease or death.|This was determined assuming a median progression free survival of 9 months and an analysis calculating the sample size at which the narrowing of its 95% confidence interval became greater than .20 for every 2 patients added. Progression free survival and overall survival were estimated by using the Kaplan Meier method.||months||95% Confidence Interval|Median
154698|NCT00342628|Secondary|Antibody Responses to Hib CP|IgG anti-Hib CP was measured by ELISA in sera of 30 randomly chosen infants per group|Cord sera and infant sera at 7, 12, and 13 months|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.||mcg/ml||Inter-Quartile Range|Geometric Mean
154699|NCT00342628|Secondary|Antibody Responses to Tetanus Toxoid, Diphtheria Toxoid, and Pertussis Toxin|IgG anti-diphtheria toxoid (DT), -tetanus toxoid (TT) and -pertussis toxin (PT) were measured by ELISA in sera of 30 randomly chosen infants per group.|Cord sera, and infants' sera at 7, 12 and 13 months of age|Randomly chosen 30 participants in each group. Four in Comparison group 2 were excluded from analyses due to classification error.||U/ml||Inter-Quartile Range|Geometric Mean
154700|NCT00342628|Secondary|IgG Anti-Vi Levels|IgG anti-Vi was measured by ELISA and expressed as ELISA units (EU)in all sera.|cord sera, infants' sera at 7, 12 and 13 months|Only participants with available cord sera are included in the analyses||ELISA units||Inter-Quartile Range|Geometric Mean
154701|NCT00342628|Primary|Number of Infants With Adverse Reactions After Vaccination|Number of infants with Fever>=38.0 C, Induration>=2.5cm at DTP site, Induration>=2.5cm,Vi-rEPA/Hib-TT site, Erythema>=2.5cm, at DTP site, Erythema>=2.5cm, Vi-rEPA/Hib-TT site, Inconsolable crying<4hr, Inconsolable crying>=4hr per injection with Vi conjugate vaccine given in conjunction with DTP in infants.|at 2, 4, 6 and 12 months|The number of infants injected in each group for each injection was used to determine the rate of adverse reactions.||participants|||Number
154702|NCT00342355|Primary|Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.|Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.|January 2004 until March 31 2008|||participants|||Number
154703|NCT00342355|Secondary|Serious Adverse Events|Safety outcomes in four different randomly assigned regimens|January 2004 until March 31, 2008|||participant|||Number
154704|NCT00340834|Secondary|Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||Percentage of participants||95% Confidence Interval|Number
154705|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Month 12 to end of study (up to approximately 3.5 years)|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||T2 lesions||Standard Deviation|Mean
154706|NCT00340834|Secondary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Month 0 to end of study (up to approximately 4.5 years)|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.||Estimated relapses per year||95% Confidence Interval|Number
154707|NCT00340834|Secondary|Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study|The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||Percentage of participants||95% Confidence Interval|Number
154722|NCT00340704|Secondary|Cpre,ss|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose, Cpre,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS): This set includes subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
154708|NCT00340834|Secondary|Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study|The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to Month 12|Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.||T2 lesions||Standard Deviation|Mean
154709|NCT00340834|Primary|Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.|Baseline to Month 12|Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.||Estimate relapses per year||95% Confidence Interval|Number
154710|NCT00340704|Secondary|RA,Cmax|The accumulation ratio was calculated from the patients who were randomised to the low dose group and for whom both parameters at first dose and steady state dose were available. Accumulation ratios of tamsulosin HCl in plasma at steady state after multiple dose administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose. The accumulation ratio RA,Cmax was calculated as: Cmax,ss/Cmax,1. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results from this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||Ratio||Geometric Coefficient of Variation|Geometric Mean
154711|NCT00340704|Secondary|Vz/F,ss,W,Norm|Weight-normalized Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration), Vz/F,ss,W,norm. Weight-normalized VzF,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||L/kg||Geometric Coefficient of Variation|Geometric Mean
154712|NCT00340704|Secondary|CL/F,ss,W,Norm|Weight-normalized CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration), CL/F,ss,W,norm. Weight-normalized CL/F,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
154713|NCT00340704|Secondary|MRTpo,ss|Mean residence time of the analyte in the body at steady state after oral administration,MRTpo,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||hours||Geometric Coefficient of Variation|Geometric Mean
154714|NCT00340704|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state, t1/2,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||hours||Geometric Coefficient of Variation|Geometric Mean
154715|NCT00340704|Secondary|λz,ss|Terminal rate constant of the analyte in plasma at steady state, λz,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||1/hours||Geometric Coefficient of Variation|Geometric Mean
154716|NCT00340704|Secondary|AUCτ ,ss ,DW ,Norm|Dose- and weight-normalized of AUCτ ,ss ( AUCτ ,ss ,DW ,norm). Weight normalization of AUCτ,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng*h/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
154717|NCT00340704|Secondary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ , AUCτ,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
154718|NCT00340704|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ, tmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||hours||Full Range|Median
154719|NCT00340704|Secondary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmin,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng/mL||Geometric Coefficient of Variation|Geometric Mean
154720|NCT00340704|Secondary|Cmax,ss, DW, Norm|Dose- and weight-normalized for Cmax,ss, Cmax,ss, DW, norm. Weight normalization of Cmax,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.|Pharmacokinetics steady state set (PK-SS)||ng/mL/mg*kg||Geometric Coefficient of Variation|Geometric Mean
154724|NCT00340704|Secondary|Tmax, 1|Time from dosing to maximum measured concentration of the analyte in plasma after administration of the first dose, tmax, 1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD)||hours||Full Range|Median
154725|NCT00340704|Secondary|Cmax,1|Maximum measured concentration of the analyte in plasma following the first dose, Cmax,1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.|−0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.|Pharmacokinetics single dose set (PK-SD): This set includes subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK at Visit 2.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
154726|NCT00340704|Secondary|Vision Testing for Group D-527.51 Rollover|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 52|Treated Set (TS)||Participants|||Number
154727|NCT00340704|Secondary|Vision Testing for Group D-Denovo|Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-Denovo subjects, so results of this group is provided.|Baseline, Week 26 and Week 52.|Treated Set (TS)||Participants|||Number
154728|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Subjects who experienced orthostatic hypotension during orthostatic testing were reported as adverse events. This Outcome Measure was only pre-specified for Group D-Denovo, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 450 days|Treated Set (TS)||Participants|||Number
154729|NCT00340704|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover|Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Below mentioned result are the number of subjects who had the clinical relevant abnormalities for the preferred term 'Hepatic enzyme increased'. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|From first drug administration until 28 days after last study drug administration, upto 395 days|Treated Set (TS)||Participants|||Number
154730|NCT00340704|Secondary|LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover|Response rates of LPP responders (2 LPP values < 40 cm H2O) at any time during the trial by treatment group. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Week 1 to Week 52 (described study wise in the Description).|Full analysis set (FAS-LPP)||participants|||Number
154731|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydronephrosis in the Group D-527.51 Rollover. Hydronephrosis response is defined as an improvement or stabilization based upon ultrasound grading at the end of the study. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL). This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.||Participants|||Number
154741|NCT00340379|Primary|Clinical Global Impression Improvement Scale|A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).|12 weeks|||units on a Clinical Impressions Scale||Standard Deviation|Mean
154742|NCT00340379|Primary|21 Item Hamilton Depression Rating Scale|The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).|12 week|Number of participants was ITT and imputed by LOCF||Units on Hamilton Depression Scale||Standard Deviation|Mean
154732|NCT00340704|Secondary|Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover|Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydroureter in the Group D-527.51 Rollover. Hydroureter response is defined as improvement or stabilization based upon the presence or absence of hydroureter at end of treatment compared to baseline. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.|Full analysis set (FAS-RENAL): Includes all patients in the Treated set who received one dose of treatment and had one on treatment renal measurement.||Participants|||Number
154733|NCT00340704|Secondary|Percent Change From Baseline in LPP for Group D-527.51 Rollover|Percent change from baseline in actual detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and Week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and Week 1|Full analysis set (FAS-LPP)||percent change||Standard Deviation|Median
154734|NCT00340704|Secondary|Change From Baseline in LPP for Group D-527.51 Rollover|Median change from baseline in detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Baseline and week 1|Full analysis set (FAS-LPP)||cm H2O||Standard Deviation|Median
154735|NCT00340704|Secondary|Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover|Early responders who maintained their detrusor leak point pressure (LPP) below 40 cm H2O during the study. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2,3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, However this endpoint was not analysed for Group D-527.51 Rollover as very limited data were collected due to early termination of the study & no alternative endpoint was defined in the Group D-527.51 rollover, so only the results for Group D-Denovo is provided.|Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).|Full analysis set (FAS-LPP)||Participants|||Number
154736|NCT00340704|Primary|Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.|Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low Dose, MD: Medium Dose and HD: High Dose This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.|Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.|Full analysis set (FAS-LPP)||Participants|||Number
154737|NCT00340704|Primary|Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover|Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure <40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique, a cystometrogram. Descriptive statistics were used to assess this endpoint. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.|Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.|Full analysis set (FAS-LPP): This subject set includes all subjects in the Treated set who received one dose of treatment and had one on treatment LPP measurement.||percentage of responders|||Number
154738|NCT00340678|Secondary|Glomerular Volume||6 years after first treatment|Intention-to-treat||*10^6 cubic microns||Standard Deviation|Mean
154739|NCT00340678|Primary|Number of Participants With Decline in GFR|Participants were monitored for up to 6 years. This is the number of participants who had a decline in GFR to less than or equal to 60 ml/min or to half the baseline value in subjects that enter the study with a GFR of less than 120 ml/min during the time of observation.|Up to 6 years|Intention-to-treat||participants|||Number
154740|NCT00340379|Primary|Brief Psychiatric Rating Scale at 12 Weeks|A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.|12 weeks|||units on a Psychiatric Rating scale||Standard Deviation|Mean
154745|NCT00339183|Secondary|Number of Participants With Adverse Events (AEs)|"A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: “Is there a reasonable possibility that the event may have been caused by the study treatment?"|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.|Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.||participants|||Number
154746|NCT00339183|Secondary|Duration of Response|"Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Central Tumor Response Analysis Set: Responders||months||95% Confidence Interval|Median
154747|NCT00339183|Secondary|Time to Disease Progression|"Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
154748|NCT00339183|Secondary|Percentage of Participants With an Objective Response|Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.|Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.|KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.||percentage of participants||95% Confidence Interval|Number
154749|NCT00339183|Primary|Overall Survival|Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.|From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months|KRAS Efficacy Analysis Set||months||95% Confidence Interval|Median
154750|NCT00339183|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.~Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions."|From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.|KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)||months||95% Confidence Interval|Median
154751|NCT00339144|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all target/non-target lesions; PR: >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Within 4 weeks of first study drug administration, thereafter recorded every 4 or 8 weeks.|All treated participants with measurable disease at baseline and received at least one dose of the study drug (efficacy population).||participants|||Number
154752|NCT00339144|Secondary|Number of Participants With Sarcoma (Src) and Phosphorylated Src (pSRc) Protein Expression in Peripheral Blood Mononuclear Cells (PBMC)|Src and pSrc protein expression was planned to be evaluated in PBMC for establishing PK/PD relationship between Src/pSrc protein expression in PBMC and exposure of BMS-354825.|Plasma samples were collected on baseline (Day -1), 0 hour (pre-dose), 1 and 4 hours (post-dose) on Days 1, 14 and 28|All treated participants with adequate pharmacodynamic profiles. Participants could not be evaluated as the test was discontinued due to difficulty in appropriate measurements.||participants|||Number
154753|NCT00339144|Secondary|Mean Serum Concentration of Bone Alkaline Phosphatase (BAP) Biological Marker|BAP is a measure of bone metabolism. A decrease in BAP relative to the baseline indicates decrease in bone metabolism. Serum BAP was quantified with ELISA.|Serum samples were assessed on baseline (Day -1), and pre-dose on Days 14, 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||U/L||Standard Deviation|Mean
154754|NCT00339144|Secondary|Mean Serum Concentration of Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP-5b) Biological Marker|TRACP-5b is a measure of bone metabolism. A decrease in TRACP-5b relative to the baseline indicates decrease in bone metabolism. Serum TRACP-5b was quantified with enzyme-linked-immunosorbent serologic assay (ELISA).|Serum samples were assessed at baseline (Day -1) and on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||U/L||Standard Deviation|Mean
154755|NCT00339144|Secondary|Mean Urine Concentration of Deoxypyridinoline (Dpyr) Biological Marker|Urine levels of DPyr is a measure of bone resorption. A decrease in Dpyr relative to the baseline indicates decrease in bone metabolism. Mean urine concentration of Dpyr biological marker was determined using ELISA.|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6 12 and 24 hours post dose on Days 14 and 28|All treated participants with adequate PD profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||nanomol (nmol)/mL||Standard Deviation|Mean
154756|NCT00339144|Secondary|Mean Urine Concentration of Urinary N-telopeptide Type 1 Collagen (NTx) Biological Marker|Urine NTx is a measure of bone metabolism. A decrease in the marker relative to baseline indicates a decrease in bone metabolism. Mean urine concentration of NTx biological marker was determined using enzyme linked immuno-sorbent assay (ELISA).|Urine samples were collected at baseline (Day -1) and 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28.|All treated participants with adequate pharmacodynamic (PD) profiles (PD population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||nmol*bone collagen equivalent (BCE)/mmol||Standard Deviation|Mean
154757|NCT00339144|Secondary|Tmax of the Metabolite BMS-582691|Tmax of the metabolite was obtained using plasma concentration versus time data of metabolite BMS-582691.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||hours||Full Range|Median
154758|NCT00339144|Secondary|AUC (0-t) of Metabolite BMS-582691|AUC (0-t) was calculated using plasma concentration values of metabolite at time 0 to the time of the last measurable concentration (t).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ng*hr/mL||Full Range|Geometric Mean
154759|NCT00339144|Secondary|Cmax of Metabolite BMS-582691|Maximum plasma concentration was obtained from plasma concentration versus time data of metabolite (BMS-582691).|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ng/ml||Full Range|Geometric Mean
154760|NCT00339144|Secondary|Mean Apparent Volume of Distribution (Vz/F) of Dasatinib|Apparent volume of distribution after oral dosing was obtained from plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||L||Full Range|Geometric Mean
154761|NCT00339144|Secondary|Mean Apparent Oral Clearance (CLo) of Dasatinib|Apparent oral clearance was obtained from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||L/hour||Full Range|Geometric Mean
154762|NCT00339144|Secondary|Accumulation Index (AI) of Dasatinib|AI of Dasatinib was calculated as ratio of geometric mean of AUC(TAU) (area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration) on Day 14 or Day 28 on Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ratio||Full Range|Geometric Mean
154763|NCT00339144|Secondary|Terminal Elimination Half-life (T-half) of Dasatinib|T-half of dasatinib was calculated using plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||hours||Standard Deviation|Mean
154764|NCT00339144|Secondary|Time to Reach Maximum Observed Plasma Concentration of Dasatinib (Tmax)|Tmax, time to reach maximum observed plasma concentration of dasatinib was obtained directly from the plasma concentration versus time data.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||hours||Full Range|Median
154765|NCT00339144|Secondary|AUC[TAU] of Dasatinib|Area under the plasma concentration-time curve within the dosing interval was determined. AUC(TAU), from time 0 to the time of the last measurable concentration (24 hours) was calculated for Day 1, 14, 28 respectively.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate PK profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||ng*hours/ml||Full Range|Geometric Mean
154766|NCT00339144|Secondary|Area Under the Plasma-concentration-time Curve [AUC (INF)] of Dasatinib on Day 1|AUC(INF), area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration within the dosing interval was calculated for Day 1.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Day 1|All treated participants with adequate PK profiles (PK population).||ng*hours/ml||Full Range|Geometric Mean
154767|NCT00339144|Secondary|Maximum Plasma Concentration (Cmax) of Dasatinib|Cmax was obtained from the plasma concentration versus time data after oral administration of dasatinib.|Blood samples were collected at 0 hour (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 12 and 24 hours (post dose) on Days 1, 14 and 28|All treated participants with adequate pharmacokinetic (PK)profiles (PK population). The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).||nanograms (ng)/ml||Full Range|Geometric Mean
154768|NCT00339144|Secondary|Number of Participants With Clinically Significant Change in QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial ECGs.|Baseline, Day 1, Day 14 and Day 28|All participants who received at least one dose of the study drug (safety population).||participants|||Number
154769|NCT00339144|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Standard 12-lead ECG was used to record selected ECG parameters like RR interval (the time between the two R waves in ECG), PR interval (interval measured from the beginning of the P wave to the beginning of the QRS complex; QRS complex is the name for some of the deflections seen on a typical ECG)), QRS duration, QT interval (time between onset of ventricular depolarization and end of ventricular repolarization), QT interval corrected for heart rate using Bazett's (QTcB) and Fridericia's (QTcF) formulas.|From screening Day -1, and at pre-dose, 1 and 4 hours (post-dose) on Days 1, 14 and 28 in first treatment course, at pre-dose, 1 and 4 hours (post-dose) during the second and fourth week in subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).||participants|||Number
154770|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Vital Signs|Vital signs measurements (including blood pressure, body temperature and pulse rate) were recorded. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs were clinically significant.|From screening, Day 1 , 8, 15 and 22 in the 1st treatment course, Day 8 and 22 in the second and subsequent courses and at the end of study|All participants who received at least one dose of the study drug (safety population).||participants|||Number
154771|NCT00339144|Secondary|Number of Participants With Clinically Meaningful Physical Examination Measures|Interim and final physical examinations were performed. The investigator used his/her clinical judgment to decide whether or not physical examination findings were clinically significant.|From screening, Day 1 in each treatment course and at the end of study|All participants who received at least one dose of the study drug (safety population). Analysis for significant physical examination findings was not done.||participants|||Number
154772|NCT00339144|Secondary|Most Frequent Serum Chemistry Laboratory Abnormalities Occurring in >=10% Participants: High Magnesium|Abnormalities were graded according to the NCI-CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent (>=10%) serum laboratory abnormalities were recorded. The following definitions specify the NCI-CTC AE criteria for serum laboratory abnormalities in the data presented: magnesium: Grade 3: >3.0 - 8.0 mg/dL or >1.23 - 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).||participants|||Number
154773|NCT00339144|Secondary|Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=10% Participants: Low Lymphocyte Count|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Most frequent hematology Grade 3 and 4 abnormalities occurring in >=10% participants were recorded. Grade 3 and 4 criteria are as follows: lymphocyte count: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All treated participants who received at least one dose of the study drug.||participants|||Number
154774|NCT00339144|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded according to the NCI CTC, version 3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: phosphorous: Grade 3: 1.0-<2.0 mg/dL, Grade 4: <1.0 mg/dL; calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; magnesium: Grade 3: >3.0 – 8.0 mg/dL or >1.23 – 3.30 mmol/L, Grade 4: >8.0 mg/dL or >3.30 mmol/L; albumin: Grade 3: <2 g/dL or <20 g/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.||participants|||Number
154775|NCT00339144|Secondary|Number of Participants With Grade 3 or 4 Hematology Abnormalities|Hematology abnormalities were graded per the National Cancer Institute (NCI) Common. Terminology Criteria (CTC) version 3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L; lymphocytes: Grade 3: 0.2 - <0.5*10^9/L, Grade 4: <0.2*10^9/L.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug.||participants|||Number
154776|NCT00339144|Secondary|Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs (SAEs), Drug Related AEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs: events with a relationship to the study therapy of certain; probable; possible; not likely or unrelated.|From start of study drug therapy up to 30 days after the last dose.|All participants who received at least one dose of the study drug (safety population).||participants|||Number
154777|NCT00339144|Primary|Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment|MAD: highest dose level at which >=1 DLTs were reported, MTD: dose one step lower than MAD. DLT: any of the following considered related to dasatinib during course 1:Grade 3(dose reduction by 1 dose level)/Grade 4:recurring nausea, vomiting or diarrhea; any other Grade >=3 non-hematologic toxicity except alopecia or fatigue;any grade toxicity requiring two dose reductions or participant's discontinuation; Grade 4 neutropenia <500 cells/mm^3 for >=5 consecutive days or febrile neutropenia; Grade 4 thrombocytopenia <25,000 cells/mm^3 or Grade 3 bleeding requiring platelet transfusion.|From start of the treatment i.e.Day 1 to end of Cycle 1 i.e. Day 30 (4 weeks)|All treated participants who received at least one dose of the study drug and were evaluable for DLT.||participants|||Number
154778|NCT00339040|Secondary|HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing HIV-1 viral load.||Log10(copies/mL)||95% Confidence Interval|Log Mean
154779|NCT00339040|Secondary|CD4 Percent Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4%.||percentage of total lymphocytes||95% Confidence Interval|Mean
154780|NCT00339040|Secondary|CD4 Count Over Time||Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.|Any participant who received at least one study vaccine/placebo and with non-missing CD4 counts.||cells/µL||95% Confidence Interval|Mean
154781|NCT00339040|Primary|Serum Anti-HPV Antibody Titers (cLIA)|Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)|Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline as well as any participants with any missing values at any time points.||milli-Merck units [mMU]/mL||95% Confidence Interval|Geometric Mean
154782|NCT00339040|Primary|Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion|Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.|At week 28 after beginning the vaccination series|The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.||percent of participants||95% Confidence Interval|Number
154783|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, Treatment related, Non-treatment related, Baseline, Possibly treatment related."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis||percent of participants||95% Confidence Interval|Number
154784|NCT00339040|Primary|Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)|"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. All grade 3 and higher signs, symptoms, and laboratory toxicities were included."|Within 14 days of first three doses of vaccination|Any participant who received at least one study vaccine/placebo were included in the safety analysis.||percent of participants||95% Confidence Interval|Number
154785|NCT00338988|Primary|Number of Participants With Objective Response|Objective Response = Complete Response + Partial Response. Response evaluated using modification of new international criteria proposed by RECIST [changes in only largest diameter (unidimensional measurement) of tumor lesions used in the RECIST criteria]. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline with restaging every 3 cycles (cycle=21 days)|Analysis was per protocol. One participant was found ineligible and received no treatment.||participants|||Number
154786|NCT00338962|Primary|Mean Number of Side Effects|Differences in mean number of side effects reported for each group. Side effects and common adverse symptoms were evaluated by the research staff weekly, using a modified version of the ystematic Assessment for Treatment Emergent Events. The symptoms that are known to be associated with treatment with desipramine, paroxetine, and naltrexone were specifically screened or on a weekly basis. The symptoms were then clustered into the following categories: gastrointestinal, emotional, cold and flu symptoms, skin, sexual, neurological, and cardiac.|12 weeks|||side effects||Standard Error|Mean
154787|NCT00338962|Primary|Hamilton Depression Rating Scale (HAM-D)|The HAM-D ranges from 0 (Normal) to >23 (Very Severe Depression)|beginning of treatment (week 1), and end of treatment (13 weeks)|||units on a scale||Standard Error|Mean
154788|NCT00338962|Primary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to:~Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD"|beginning of treatment (week 1), and end of treatment (13 weeks)|||units on a scale||Standard Error|Mean
154789|NCT00338962|Primary|Mean Self-report Weekly Craving Via Obsessive Compulsive Drinking Scale (OCDS)|The OCDS is a 14-item (rated 0-4), self-administered questionnaire for characterizing and quantifying the obsessive and compulsive cognitive aspects of craving and heavy (alcoholic) drinking, such as drinking-related thought, urges to drink, and the ability to resist those thoughts and urges. A higher total score indicates higher craving and ranges from 0-48.|beginning of treatment (week 1), and end of treatment (13 weeks)|||units on a scale||Standard Error|Mean
154790|NCT00338884|Secondary|Cancer Related Symptoms, Well-Being, and Concerns|FACT-Advanced Kidney Cancer Symptom Index (FKSI) Questionnaire: subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions. Each question was answered on a 5-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns). End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.||scores on a scale||Standard Deviation|Mean
154838|NCT00337987|Primary|Number of Patients That Achieved a Complete Response (CR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years|||participants|||Number
154791|NCT00338884|Secondary|Patient-Assessed Fatigue|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Total FACIT-Fatigue score = sum score of the 13 question scores; total range: 0 - 52; higher total score represents less fatigue. End of treatment assessment was for subjects who completed the study only.|Baseline (Day 1, Week 1), Day 1 of Weeks 3, 5, 7, 9, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, Week 53 (End of Treatment)|Safety population. Number of Participants analyzed = number of subjects evaluable for the FACIT-Fatigue analysis. n=number of subjects with scores at each time point.||scores on a scale||Standard Deviation|Mean
154792|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
154793|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
154794|NCT00338884|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.||ratio||Standard Deviation|Mean
154795|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
154796|NCT00338884|Secondary|sVEGFR2 at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of sVEGFR2 at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
154797|NCT00338884|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.||pg/mL||Standard Deviation|Mean
154798|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 12 weeks] versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
154799|NCT00338884|Secondary|VEGF Ratio to Baseline Stratified by Tumor Response (CR or PR Versus PD)|Median VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR versus PD).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data and tumor response. n=number of subjects with evaluable data and tumor response at each specified time point. No subjects had PD following Week 33.||ratio||Full Range|Median
154800|NCT00338884|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Day 1 of Weeks 3 through 53|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline. n=number of subjects with evaluable data at each specified time point.||ratio||Standard Deviation|Mean
154801|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR or SD versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
154802|NCT00338884|Secondary|VEGF at Baseline Stratified by Tumor Response (CR or PR Versus PD)|Summary statistics of VEGF at baseline by group (CR or PR versus PD) are presented.|Baseline (Cycle 1, Day 1)|Safety population. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL||Full Range|Median
154803|NCT00338884|Secondary|Vascular Endothelial Growth Factor (VEGF) Concentration at Baseline||Baseline|Safety population. Number of Participants analyzed = number of subjects with evaluable data at baseline.||picograms (pg)/mL||Standard Deviation|Mean
154804|NCT00338884|Secondary|Ctrough Correlated With Serious Adverse Events (SAEs)|Serious adverse event defined as any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Ctrough correlation analyses with SAEs were not performed due to low frequency of individual SAEs.|||||
154805|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
154890|NCT00337467|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24||Baseline, Week 24|n=number of participants with CD4 cell count at baseline and at Week 24||cells /mm3||Standard Deviation|Mean
154806|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for Total Drug (Sunitinib + SU012662)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
154807|NCT00338884|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.||ng/mL||Standard Deviation|Mean
154808|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [SD > = 12 Weeks] Versus PD) for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
154809|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus PD for SU-012662 (Sunitinib's Metabolite)|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
154810|NCT00338884|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.||ng/mL||Standard Deviation|Mean
154811|NCT00338884|Secondary|Ctrough Stratified by Tumor Response (CR or PR or [Stable Disease (SD) > = 12 Weeks] Versus PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR or SD versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
154812|NCT00338884|Secondary|Ctrough Stratified by CR or PR Versus Progressive Disease (PD) for Sunitinib|Summary statistics of ctrough at each time point by group (CR or PR versus PD) are presented.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|PK. Number of Participants analyzed = number of subjects with evaluable PK data and tumor response at baseline. n=number of subjects with evaluable PK data and tumor response at each specified time point. No subjects had PD following Week 33.||ng/mL||Full Range|Median
154813|NCT00338884|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Predose on Day 1 of Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53|Pharmacokinetic (PK) population = treated and had least 1 PK sample taken. Number of Participants analyzed = number of subjects evaluable for PK analysis. n=number of subjects evaluable at each time point.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
154814|NCT00338884|Secondary|1-Year Survival|One year survival rate defined as the probability that a subject was alive 1 year after the date of first study treatment.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter up until 1 year|Safety population. Number of participants analyzed = number of subjects evaluable for 1 year survival analysis.||percent chance of survival||95% Confidence Interval|Median
154815|NCT00338884|Secondary|Progression-Free Survival (PFS)|Time from start of study medication to first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date minus first dose date +1)/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death|Safety population. Number of participants analyzed = number of subjects evaluable for PFS analysis.||months||95% Confidence Interval|Median
154816|NCT00338884|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to first documentation of objective tumor progression. The 50% quartile point estimate is provided. The criteria for tumor progression was according to RECIST.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety population. 64 subjects were censored. Number of participants analyzed = number of subjects evaluable for tumor progression analysis.||months||95% Confidence Interval|Median
154817|NCT00338884|Secondary|Duration of Response (DR)|Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter or death due to any cause|Safety population subgroup of subjects with a confirmed objective tumor response. DR was only calculated for the subgroup of subjects with a confirmed objective response.||months||95% Confidence Interval|Mean
154818|NCT00338884|Primary|Number of Subjects With Overall Confirmed Objective Response (OR)|OR = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) persisting > = 4 weeks after initial documentation of response. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter|Safety Population=all enrolled subjects who received at least 1 dose of sunitinib. For OR rate analysis, subjects who did not have a baseline assessment of disease were excluded from the analysis. Number of participants analyzed = number of subjects evaluable for OR analysis.||participants|||Number
155207|NCT00333437|Secondary|Mean Change in Bronchoalveolar Lavage (BAL) Components (Neutrophils, Eosinophils)|BAL samples were colleected from the affected lobe (as determined by lung CT scans) before beginning and after completing study therapy.|Baseline, 12 months|||Cells/uL||Standard Deviation|Mean
154819|NCT00337779|Secondary|The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).|"The Frequent MRI Cohort was a subset of subjects consisting of 234 subjects, for whom MRI scans were performed at months 0 (baseline), 1, 2, 3, 6, 9 and 12. Analysis of the endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression with an offset variable employing the log of the porportion of the number of available post-baseline scans to adjust for missing MRI scans (if any) and including the number of T1 Gd-enhancing lesions at baseline and (pooled) center as covariates."|12 months|Frequent MRI cohort||T1 Enhancing Lesions||Standard Deviation|Log Mean
154820|NCT00337779|Secondary|The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan.|The analysis of this endpoint was based on the outcome of a contrast derived from a baseline-adjusted Negative Binomial Regression including the number of T1 Gd-enhancing lesions at baseline, the volume of T2 lesions at baseline and (pooled) center as covariates.|12 months|||T2 Lesions||Standard Deviation|Mean
154821|NCT00337779|Primary|The Rate of Confirmed Relapses During the Double-blind Phase (12 Months).|A confirmed relapse is defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities. This change in clinical state must last at least 48 hours and be immediately preceded by an improving neurological state of at least thirty (30) days from onset of previous relapse.|12 months|ITT||Number of relapses per patient||Standard Deviation|Mean
154822|NCT00338741|Secondary|Fetal Death/Stillbirth|Fetal death/stillbirth|Up to 10 months|||Participants|||Number
154823|NCT00338741|Primary|Spontaneous Abortion|Number of participants having spontaneous abortion|Up to 9 months|Population includes all subjects for whom data is available||Participants|||Number
154824|NCT00338455|Secondary|Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
154825|NCT00338455|Secondary|All Cause Mortality||Day 30 and Months 2 and 6|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
154826|NCT00338455|Secondary|Changes in Pulmonary Capillary Wedge Pressure (PCWP)||28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
154827|NCT00338455|Primary|Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment)|Number of calendar days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (termination of treatment or early discontinuation of treatment, whichever occurred first). The endpoint was not normalized for time on study.|28 days|Early termination of the study due to enrollment difficulties; efficacy not analyzed.|||||
154828|NCT00338286|Secondary|Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs)|Suspected TVEs were identified by investigators and relevant clinical information was collected.|up to 8.4 years|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Percentage of participants|||Number
154829|NCT00338286|Secondary|Overall Response Rate (ORR)|Overall response was RECIST criteria. Complete response (CR) is appearance of all target and non-target lesions. Partial response (PR):a) 30% decrease in sum of lactate dehydrogenase(LD) of target lesions from baseline OR b) complete disappearance of target lesions, with persistence of one or more non-target measurable lesion or one or more non-measurable, evaluable lesions. Progressive disease(PD):a) 20% increase in sum of LDs of target lesions, taking as reference smallest sum LD recorded since treatment started; OR b) appearance of one or more new lesions or a clear worsening of measurable non-target lesions or evaluable disease with stable measurable lesions. Stable disease (SD):a) sufficient shrinkage to qualify for PR;b) sufficient increase to qualify for PD. Non evaluable(NE) lesion: all other lesions, including small lesions (longest diameter <20 millimeter (mm) with conventional techniques or <10 mm with spiral CT scan) and truly non-measurable lesions.|every 8 weeks for 1 year and then every 12 weeks until PD or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Percentage of participants|||Number
154830|NCT00338286|Secondary|Time to Tumor Progression|The Time to tumor progression (TTP) was defined as the time from the date of starting treatment until the date of first documented evidence of progression of tumor. TTP was measured from the date of randomization to the date of the first documented PD (including death due to PD without prior PD).|From date of randomization to the date of the first documented PD (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Months||95% Confidence Interval|Median
154831|NCT00338286|Secondary|Overall Survival|Overall survival (OS) was defined as the interval between the date of randomization to the date of death from any cause. For participants who were lost to follow-up or withdrew before the clinical cutoff, OS was censored at the last date the participants was known to be alive. For participants who were still alive and on study at the time of the clinical cutoff, OS was censored at the date of clinical cutoff.|From randomization up to death from any cause (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Months||95% Confidence Interval|Median
154832|NCT00338286|Primary|Progression Free Survival|Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cutoff were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.|From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)|The intent to treat (ITT) population included all participants who were randomized in either Standard of Care (SOC) or Epoetin alfa group.||Months||95% Confidence Interval|Median
154833|NCT00338104|Secondary|Percentage of Glucose Levels > 180 mg/dL|Percentage of blood glucose levels > 180 mg/dL|First 24 hours after conversion|||percentage of blood glucose values|||Number
154834|NCT00338104|Secondary|Percentage of Glucose Values < 50 mg/dL|Percentage of blood glucose values < 50 mg/dL|First 24 hours after conversion|||percentage of blood glucose values|||Number
154839|NCT00337987|Primary|Number of Patients That Achieved a Complete Response or a Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 4 years|||participants|||Number
154840|NCT00337935|Secondary|Time to Hemoglobin Response|Time to hemoglobin reponse was defined as the time between individual treatment start date and the first of 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL. Note: Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.||Days||95% Confidence Interval|Median
154841|NCT00337935|Secondary|The Number of Patients Achieved a Hemoglobin Response.|Hemoglobin reponse was defined as 2 consecutive hemoglobin measurements at least 1.0 g/dL above baseline or 2 consecutive hemoglobin measurements at least 11.0 g/dL|Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.||participants|||Number
154842|NCT00337935|Primary|Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)||Week 0 to Week 26|Modified intent to treat (mITT) - all subjects with at least 1 hemoglobin measurement after baseline. Four subjects did not have hemoglobin measurement post baseline.||g/dL||Standard Deviation|Mean
154843|NCT00337818|Secondary|Number of Subjects Reporting SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort of each time point.||Subjects|||Number
154844|NCT00337818|Secondary|Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.|Throughout the study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.||Subjects|||Number
154845|NCT00337818|Secondary|Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 24, 36 and 48|Analysis was performed on the Total Vaccinated Cohort, on subjects with cervicovaginal secretion sample results available and with cervicovaginal secretion samples having less than 200 erythrocytes per milliliter and with results available for the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
154846|NCT00337818|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At months 24, 36, and 48|Analysis was performed on the ATP cohort for analysis of immunogenicity, in post-menarcheal subjects who volunteered for cervicovaginal sampling collection and with cervicovaginal secretion samples having less than 80 erythrocytes per milliliter and with results available for the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
154847|NCT00337818|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|"Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).~*Data for Month 18 outcome variables were incorporated into the Month 24 analyses."|At months 18*, 24, 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
154848|NCT00337727|Secondary|Number of Patients Who Reported Complete Response|The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.|Overall phase (0-120 hours post initiation of MEC) in Cycle 1|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received MEC, (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.||Participants|||Number
154849|NCT00337727|Primary|Number of Patients Who Reported No Vomiting|"The number of patients who reported No Vomiting in the overall phase in Cycle~1"|Overall phase (0-120 hours post initiation of MEC) in Cycle 1.|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderately Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment.||Participants|||Number
154850|NCT00337675|Secondary|Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes|Each day during an asthma episode, the patient’s legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.|1 Year|Patients with at least one episode culminating in an attack were included; therefore, 1120 patients were included in the analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
154851|NCT00337675|Secondary|Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode|Each day during an asthma episode, the patient’s legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.|1 Year|Only patients who experienced an asthma attack within an episode and did not start their intermittent study medication on the day of the attack could be included. Therefore, a total of 452 patients were included in this analysis.||Units on a Scale||95% Confidence Interval|Least Squares Mean
154852|NCT00337675|Primary|Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period|The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient’s legal guardian recorded all the HRU that was required specifically for breathing problems.|1-year treatment period|Full Analysis Set (FAS): all randomized patients who took at least one dose of blinded study drug. Of 1771 patients randomized, 5 never took study drug and 9 were not included due to Good Clinical Practice compliance concerns. Therefore, 1757 patients were included in the FAS population.||Asthma attacks within episodes per year||95% Confidence Interval|Mean
154853|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight|Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||kilograms||Standard Deviation|Mean
154854|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure|Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||mm Hg||Standard Deviation|Mean
154855|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate|Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||beats per minute||Standard Deviation|Mean
154856|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure|Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||mm Hg||Standard Deviation|Mean
154857|NCT00337662|Secondary|Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure|Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5- visit 9) visits.||mm Hg||Standard Deviation|Mean
154858|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate|Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.|Week 2 and Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||beats per minute||Standard Deviation|Mean
154859|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score|A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||units on a scale||Standard Deviation|Mean
154860|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score|Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||units on a scale||Standard Deviation|Mean
154861|NCT00337662|Secondary|Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale|Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||units on a scale||Standard Deviation|Mean
154862|NCT00337662|Secondary|Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants|Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.|Week 2 to Week 12|Total number of patients with the lab test at baseline and post-baseline.||participants|||Number
154863|NCT00337662|Secondary|Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||kilogram per square meter||Standard Deviation|Mean
154864|NCT00337662|Secondary|Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups|Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
154931|NCT00337194|Other Pre-specified|Fc Gamma Receptor Polymorphisms|Fisher’s exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a|Baseline|Fc gamma receptor polymorphisms were assessed in 28 participants.||participants|||Number
154865|NCT00337662|Secondary|Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 2 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 3 - visit 4) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
154866|NCT00337662|Secondary|Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission|'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
154867|NCT00337662|Secondary|The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
154868|NCT00337662|Secondary|The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score|The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.|Week 0 to Week 12|Total number of patients having nonmissing values at both baseline (last of visit 1 - visit 2) and post baseline (last of visit 5 - visit 9) visits.||participants|||Number
154869|NCT00337662|Secondary|Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).|Weeks 2, 3, 4, 6, 8, 12|Intention to treat patients with both baseline and postbaseline assessment||units on a scale||Standard Error|Least Squares Mean
154870|NCT00337662|Primary|Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients|Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).|Weeks 0, 3, 4, 6, 8, 12|Intention to treat for patients with both baseline and any postbaseline assessment||units on a scale||Standard Error|Least Squares Mean
154871|NCT00337610|Secondary|Change From Baseline in A1C at Week 30|A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.|Baseline and Week 30|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.||Percent||95% Confidence Interval|Least Squares Mean
154872|NCT00337610|Secondary|Change From Baseline in 2 Hr-PMG at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.||mg/dL||95% Confidence Interval|Least Squares Mean
154873|NCT00337610|Secondary|Change From Baseline in FPG at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the LOCF method.||mg/dL||95% Confidence Interval|Least Squares Mean
154874|NCT00337610|Primary|Change From Baseline in A1C at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 postbaseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward (LOCF) method.||Percent||95% Confidence Interval|Least Squares Mean
154875|NCT00337571|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 3 patients in the placebo group (1 no longer met study criteria, 2 did not have measurement at baseline and Week 8), and 1 participant in the 5-mg group who withdrew consent. Data set is LOCF.||kilograms||Standard Error|Mean
154876|NCT00337571|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuously throughout the study|Safety population=all randomized participants minus 1 patients in the placebo group (no longer met study criteria), and 1 participant in the 5-mg group who withdrew consent.||participants|||Number
154932|NCT00337194|Other Pre-specified|sCD30 Levels|A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups.|Up to day 21 of course 6|Nine participants submitted pretreatment sCD30 samples.||U/ml||Full Range|Median
154877|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient’s improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
154878|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
154879|NCT00337571|Secondary|Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
154880|NCT00337571|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||Participants|||Number
154881|NCT00337571|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
154882|NCT00337571|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF.||units on a scale||Standard Error|Mean
154883|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 96|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.||participants|||Number
154884|NCT00337467|Secondary|Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48|International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.|Week 48|Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.||participants|||Number
154885|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 96|n=number of treated participants with baseline measure and measure at Week 96||percent change||Standard Deviation|Mean
154886|NCT00337467|Secondary|Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48|Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.|Baseline, Week 48|n= number of treated participants with baseline measure and measure at Week 48||percent change||Standard Deviation|Mean
154887|NCT00337467|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).|From Baseline through Week 96|Treated Participants||percentage of participants|||Number
154888|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|n=number of participants with CD4 cell count at baseline and at Week 96.||cells /mm3||Standard Deviation|Mean
154889|NCT00337467|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|n=number of participants with CD4 cell count at baseline and at Week 48.||cells /mm3||Standard Deviation|Mean
154891|NCT00337467|Secondary|Proportion of Participants With Virologic Rebound Through Week 96|Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.|Through Week 96|This analysis was not done; however, percentage of participants with virologic rebound through Weeks 48 and 96 are reported in Secondary Outcome Measures 3 and 4. Time to reatment failure (defined as the earlier of virologic rebound or treatment discontinuation) is reported in Secondary Outcome Measure 5.||proportion of participants|||Number
154892|NCT00337467|Secondary|Cumulative Proportion of Participants Without Treatment Failure Through Week 100|This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).|Through Week 100|treated participants; n= the number at risk entering interval||proportion of participants|||Number
154893|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 96|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.||percentage of participants|||Number
154894|NCT00337467|Secondary|Percentage of Participants With Virological Rebound Through Week 48|Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.|Week 48|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.||percentage of participants|||Number
154895|NCT00337467|Secondary|Percentage of Participants With Treatment Failure Through Week 96|Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL.|Week 96|Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.||percentage of participants|||Number
154896|NCT00337467|Primary|Percentage of Participants With Treatment Failure Through Week 48|Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy.|Week 48|Treated participants||Percentage of Participants|||Number
154897|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
154898|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
154899|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
154900|NCT00337428|Primary|Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™|Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||ELISA units/mL||95% Confidence Interval|Mean
154933|NCT00337194|Other Pre-specified|Peak Serum Level of Monoclonal Antibody SGN-30|Record the highest serum level of monoclonal antibody SGN-30 achieved.|Up to day 21 of course 6|Data was only available on 10 participants from Arm 1. (No participants from Arm II were evaluable for this endpoint as they did not receive SGN-30 per protocol.)||mg/ml||Full Range|Median
154901|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
154902|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
154903|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™|Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
154904|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
154905|NCT00337428|Primary|Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™|Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 1 Month (1 Month Postdose 1)|Per-protocol population: participants must have no major protocol violations and must have post-vaccination data.||participants|||Number
154906|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
154907|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
154934|NCT00337194|Secondary|Overall Survival (OS) At 1 Year|Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method.|1 year|||percentage of participants||95% Confidence Interval|Median
154908|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
154909|NCT00337428|Primary|Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3)|Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||participants|||Number
154910|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
154911|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
154912|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
154913|NCT00337428|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3)|Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction.|Up to 7 Months (4 Weeks Postdose 3)|Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||milliMerck units/mL||95% Confidence Interval|Mean
154914|NCT00337350|Primary|Change From Baseline in Acute Insulin Response to Glucose (AIRG)|Acute insulin response to glucose (AIRG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. AIRG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. AIRG measures the acute(0–10 min) beta\ cell response to a glucose load calculated by the areas under the curve higher than basal insulin values. The AIRG was assessed as the incremental area under the curve (calculated by the trapezoid rule) from 0 to 10 min of the FSIVGTT.|baseline, week 8|||Units/mL per 10 minutes||Standard Deviation|Mean
154915|NCT00337350|Primary|Change From Baseline on Glucose Utilization (SG)|Glucose utilization (SG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. SG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SG represents the net fractional glucose clearance rate because of the increase in glucose independent of any increase in circulating insulin concentrations above baseline.|baseline, week 8|||min^-1||Standard Deviation|Mean
155208|NCT00333437|Primary|Mean Change From Baseline in Forced Vital Capacity (FVC)|compare pre- and post-therapy FVC (post- minus pre-). Forced vital capacity (FVC) is the volume of air (liters) that can forcibly be blown out after full inspiration.|Baseline, 12 months|||Liters||Standard Deviation|Mean
154916|NCT00337350|Primary|Change From Baseline in Insulin Sensitivity|Insulin Sensitivity (IS) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in IS between Baseline and week 8. SI was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SI represents the increase in net fractional glucose clearance rate per unit change in serum insulin concentration after the intravenous glucose load (microUnits/mL).|baseline, week 8|||microUnits/mL||Standard Deviation|Mean
154917|NCT00337285|Secondary|Change in PSQI Total Score From Baseline at Up to One Year|Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.|up to 1 year|Safety population (Defined as all subjects who were enrolled and who received at least one dose of the investigational product.)||Units on a scale||Standard Deviation|Mean
154918|NCT00337285|Secondary|Number of Participants With Improvement on CGI-I|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.|Up to 1 year|ITT||Participants|||Number
154919|NCT00337285|Primary|Change in ADHD-RS-IV Total Score From Baseline at Up to One Year|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|up to one year|Intent-to-treat (ITT). Defined as all subjects who were treated and had both the baseline and at least one post-baseline primary efficacy measurement (i.e., ADHD-RS-IV total score)||Units on a scale||Standard Deviation|Mean
154920|NCT00337272|Secondary|Daytime Function - Distress|The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 4 questions are combined and normalized, and used to describe distress.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
154921|NCT00337272|Secondary|Daytime Function - Despair|The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible. The scores of these 7 questions are combined and normalized, and used to describe despair.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 11 patients with 6 treated with Placebo and 5 with Ramelteon. Treatment period: 9 patients with 4 treated with Placebo and 5 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
154922|NCT00337272|Secondary|Daytime Function - Fatigue|The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.|Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments|Screening period: 12 patients with 6 treated with Placebo and 6 with Ramelteon. Treatment period: 11 patients with 4 treated with Placebo and 7 with Ramelteon. Withdrawal period: 8 patients with 4 treated with Placebo and 4 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
154923|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Quality of Sleep|The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Units on a Scale||Standard Deviation|Mean
154924|NCT00337272|Secondary|Qualitative Evaluation of Sleep - Global Sleep Impression|"The Patient Global Impression is a 7-point scale which asks How much has your sleep improved? with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement."|Once during the withdrawal period|||Participants|||Number
154925|NCT00337272|Secondary|Quantitative Sleep Parameters - Number of Awakenings|The subject reports how many times she woke up during the night.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Awakenings||Standard Deviation|Mean
154926|NCT00337272|Secondary|Quantitative Sleep Parameters - Total Sleep Time|The subject reports how many hours of sleep she got.|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Hours||Standard Deviation|Mean
154927|NCT00337272|Primary|Sleep Efficiency|Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed).|Every morning during the screening, treatment, and withdrawal periods|Screening period: 14 patients with 6 treated with Placebo and 8 with Ramelteon. Treatment period: 13 patients with 5 treated with Placebo and 8 with Ramelteon. Withdrawal period: 10 patients with 4 treated with Placebo and 6 with Ramelteon.||Percent sleep efficiency||Standard Deviation|Mean
154928|NCT00337207|Primary|Tumoral Blood Flow Changes||Before and after treatment||||||
154929|NCT00337207|Primary|Progression-free Survival at 6 Months|The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.|After all patients have surpassed the 6 month post-treatment timepoint|1 patient became deceased due to toxicity prior to the 6 month time point and thus, was not evaluable for the 6 month progression free survival endpoint.||Participants|||Number
154930|NCT00337207|Primary|Safety of Treatment||Throughout treatment and up to 30 days post-treatment||||||
154935|NCT00337194|Secondary|Event Free Survival (EFS)|Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Up to 10 years|||months||95% Confidence Interval|Median
154936|NCT00337194|Primary|Number of Participants With Overall Response (OR)|The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions.|Up to 10 years|||participants|||Number
154937|NCT00337168|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assess for adverse events after each induction cycle (up to two cycles) and after the one consolidation cycle|Eligible patients who started therapy||Participants with a given type of AE|||Number
154938|NCT00337168|Secondary|Number of Patients With Very Poor Risk Cytogenetics||On average, 2 weeks before treatment started|Eligible patients with acceptable centrally reviewed cytogenetics||participants|||Number
154939|NCT00337168|Secondary|Expression of Nucleoside Transporters|Expression was examined in paraffin-embedded tissue by immunohistochemistry. Intensities were scored on a 0-2+ scale. High expression was a score of 2+.|On average, two weeks before treatment started|Eligible patients who submitted paraffin-embedded tissue||participants|||Number
154940|NCT00337168|Primary|Number of Patients With Complete Remission|Complete remission is defined as: less than 5% bone marrow blasts, neutrophils greater or equal to 1,000 per microliter, platelets greater than 100,000 per microliter, no blasts in the peripheral blood, and no extramedullary disease|Between day 28 and day 35 inclusive|Eligible patients who started therapy||participants|||Number
154941|NCT00337129|Secondary|Participants With a Given Type of AE|The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.|Every 3 weeks while on protocol therapy, up to 3 years.|All eligible patients who started protocol treatment are included in analysis of toxicity||participants|||Number
154942|NCT00337129|Secondary|Overall Survival|Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.|Only eligible patients were included in the analysis.||months||95% Confidence Interval|Median
154943|NCT00337129|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration.|||months||95% Confidence Interval|Median
154944|NCT00337129|Primary|Response Probability (Confirmed Complete and Partial Responses)|Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.|Every 6 weeks until progression of disease up to a maximum of 3 years after registration|Only eligible patients were included in the analysis||participants|||Number
154945|NCT00337103|Primary|Progression Free Survival (PFS)|PFS was defined as the time (in days) from the date of randomization to the date of the first sign of disease progression based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (v 1.1) or date of death, regardless of cause. Disease progression was measured by computed tomography (CT) and magnetic resonance imaging (MRI) performed on lesions targeted at baseline for tumor assessment. Disease progression (as assessed by independent review of the imaging scans) per RECIST v 1.1 was defined as at least a 20% increase in the sum of the diameters of the target lesions (taking as reference the smallest sum on study, including the baseline sum if that is the smallest), and an absolute increase of at least 5 mm. Note that the appearance of one or more new lesions was also considered as PD.|From date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date 12 Mar 2012 or up to approximately 6 years|Data was analyzed using Safety Population defined as all subjects who received at least one dose of study treatment.||Days||Full Range|Median
154946|NCT00337103|Primary|Overall Survival (OS)|OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant died during the study, the date of death was considered the end date, 2) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 3) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.|From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years|Data was analyzed using the Intent-to-Treat Population defined as all participants who were randomized.||Days||Full Range|Median
154947|NCT00337077|Secondary|Proportion of Patients With Measurable Disease Response|Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.|Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years from study entry|Eligible and treated patients with measurable disease at baseline are included in this analysis.||Proportion of participants||90% Confidence Interval|Number
154948|NCT00337077|Primary|Proportion of Patients With PSA Response|PSA response is defined as a PSA decline from baseline value by >=50%, or normalization of PSA (<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.|Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years|Eligible and treated patients are included in this analysis.||Proportion of participants||90% Confidence Interval|Number
154949|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)||percentage|||Number
154950|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0) or Almost Clear (1)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)||percentage|||Number
154951|NCT00336973|Secondary|Proportion of Subjects With a PGA Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 168|Intent-to-treat (ITT)||percentage|||Number
154952|NCT00336973|Primary|Proportion of Subjects With a Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2)|The PGA scale used in this study was: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe|Day 84|Intent-to-treat (ITT)||percentage|||Number
154953|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)|"The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21.~Higher values represent more severe discomfort."|12 weeks|||units on a scale||Standard Deviation|Mean
154954|NCT00336895|Primary|Number of Participants With Cytomegalovirus Infection or Disease||12 weeks|||participants|||Number
154955|NCT00336895|Primary|Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)|"The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.~The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)~The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)"|screening, 2, 6 and 12 weeks|||units on a scale||Standard Deviation|Mean
154956|NCT00336856|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 30 months|||months||95% Confidence Interval|Median
154957|NCT00336856|Secondary|Time to Progression|time from start of protocol therapy until objective tumor progression|Up to 30 months|||months||95% Confidence Interval|Median
154958|NCT00336856|Primary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|every 6 - 8 weeks, up to 30 months|||percentage of participants||95% Confidence Interval|Number
154959|NCT00336700|Secondary|KRAS Mutational Status|KRAS mutation status in resected tumor specimens.|Up to 60 months|||percentage of participants|||Number
154960|NCT00336700|Secondary|Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)|Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).|Up to 60 months|||percentage of participants|||Number
154961|NCT00336700|Secondary|Estimated 1&2 Year Overall Survival (OS)|Time from from date of first study therapy to to death from any cause.|Up to 60 months|||percentage of participants||95% Confidence Interval|Number
154962|NCT00336700|Primary|2-year Recurrence Free Survival (RFS)||Up to 60 months|||percentage of participants||95% Confidence Interval|Number
154963|NCT00336700|Primary|1-year Recurrence Free Survival (RFS)||Up to 60 months|||percentage of participants||95% Confidence Interval|Number
154964|NCT00336700|Primary|Recurrence Free Survival (RFS)|The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.|Up to 60 months|||months||95% Confidence Interval|Median
154965|NCT00336583|Secondary|Worst Toxicity Grade by Patient|graded by National Cancer Institute Common Toxicity Criteria of Adeverse Event version 3.0|up to 24 weeks|||participants|||Number
154966|NCT00336583|Primary|Overall Response Rate|The Overall Response Rate is measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response will be evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.|up to 24 weeks|25 patients who had complete at least 3 cycles of ESHAOx study treatment were analyzed. 2 patients who did not completed 3 cylces of study treatment were excluded from the response analysis.||pariticipants|||Number
154967|NCT00336544|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
154977|NCT00336479|Secondary|Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir|Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.|Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85|Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
154968|NCT00336544|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations||Participants|||Number
154969|NCT00336544|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
154970|NCT00336544|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.||Participants|||Number
154971|NCT00336505|Secondary|Bacteriologic Cures in the Per Protocol Clinically Evaluable Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
154972|NCT00336505|Primary|Clinical Cures in the Per Protocol Clinically Evaluable Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug|The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations||Participants|||Number
154973|NCT00336505|Secondary|Bacteriologic Cures in the Intent to Treat Population|All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.||Participants|||Number
154974|NCT00336505|Primary|Clinical Cures in the Intent to Treat Population|Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.|Test of Cure Visit, defined as 14-22 days after the first dose of study drug.|The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.||Participants|||Number
154975|NCT00336492|Secondary|The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54|Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score <10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI.|Week 54|PUCAI remission at Week 54 analysis was based on all participants randomized at Week 8 who were evaluable for PUCAI. Fifteen participants discontinued Infliximab treatment.||Participants|||Number
154976|NCT00336492|Primary|The Number of Participants With Clinical Response at Week 8|Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by >=30% and >= 3 points, with a decrease in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient.|Week 8|The primary efficacy endpoint analysis was based on all treated participants.||Participants|||Number
154978|NCT00336479|Secondary|Number of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|After last dose of study drug up to antiviral follow-up (up to Week 72)|Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).||participants|||Number
154979|NCT00336479|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from the subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. “Study drug” includes all investigational agents (including placebo, if applicable) administered during the course of the study.|Baseline up to Week 48|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||participants|||Number
154980|NCT00336479|Secondary|Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|12 weeks after the completion of study drug dosing (up to Week 60)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants|||Number
154981|NCT00336479|Primary|Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).|24 weeks after the completion of study drug dosing (up to Week 72)|The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.||percentage of participants|||Number
154982|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
154983|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
154984|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
154985|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Increase in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
154986|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had Within ±11% Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
154987|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Bevacizumab at 6 Weeks and Had a >11% Decrease in Change of Central Subfield Thickness From 6 Weeks to 9 Weeks|The 1.25mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 9 weeks|||participants|||Number
155019|NCT00335959|Primary|Pathologic Complete Response|Pathologic complete response rates (pCR) of primary gastric adenocarcinoma when treated with oxaliplatin and capecitabine followed by capecitabine and radiation pre-operatively. On review of the resected gastric specimen and accompanying lymph nodes, pCR is no cancer recognized by the pathologist. Margins are free of tumor.|17-19 weeks|Eligible patients who completed pre-operative therapy were assessed for response.||participants|||Number
154988|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|There were no participants with a change in central subfield thickness from 3 to 6 weeks in this treatment group that had a >11% increase in change of central subfield thickness from baseline to 3 weeks.|||||
154989|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had Within a ±11% Change in Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||participants|||Number
154990|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 2.5mg Bevacizumab and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 2.5mg bevacizumab treatment group received an injection at both baseline and at 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The 2.5mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||Participants|||Number
154991|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Increase in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||Participants|||Number
154992|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had Within a ±11% Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in another Diabetic Retinopathy Clinical Research Network study 16. The pooled 1.25mg bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|3 to 6 Weeks|||participants|||Number
154993|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness From 3 to 6 Weeks Among Eyes That Received 1.25mg Injection Only and Had a >11% Decrease in Change of Central Subfield Thickness From Baseline to 3 Weeks|The 1.25mg Bevacizumab groups include the following treatment groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only. Duration of effect of Bevacizumab was based on additional improvement versus maintained improvement versus worsening within 3 to 6 weeks. Change in central subfield thickness was categorized according to whether it exceeded 11%, the reliability limit for real change determined in the DRCR.net paper, Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema.Ophthalmology 2007;114:1520-25.|3 to 6 Weeks|||Participants|||Number
154994|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
154995|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
154996|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
155036|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup||30 days|The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study.||participants|||Number
155346|NCT00330382|Secondary|Relative Percent Change in Protease Activity (Delta RFU/Min/µg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||95% Confidence Interval|Median
154997|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
154998|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
154999|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
155000|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Visual Acuity at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
155001|NCT00336323|Other Pre-specified|Change in Visual Acuity (Letters) in Bevacizumab Groups From Baseline to 3 Weeks According to Central Subfield Thickness at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure. Positive values represent an improvement in letter score.|baseline to 3 Weeks|||letters||Inter-Quartile Range|Median
155002|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Subretinal Fluid Presence at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155003|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Clinical Diabetic Macular Edema Characterization at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155004|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Retinopathy Severity at Baseline|Pooled Bevacizumab group includes treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks + laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. Retinopathy severity based on investigator discretion on clinical examination.|baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155005|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to History of Treatment for Diabetic Macular Edema at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155006|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Gender|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155007|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Age at Baseline|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155008|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Visual Acuity Letter Score|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155009|NCT00336323|Other Pre-specified|Change in Central Subfield Thickness in Bevacizumab Groups From Baseline to 3 Weeks According to Baseline Central Subfield Thickness|Pooled Bevacizumab groups include the following treatment groups: 1.25mg at baseline and at 6 weeks, 2.5mg at baseline and at 6 weeks, 1.25mg at baseline only, and 1.25mg at baseline and 6 weeks plus laser at 3 weeks. Negative values represent a reduction in central subfield thickness. The 4 bevacizumab groups (N=87) were pooled to compare differences in response at 3 weeks among subgroups of interest. The pooled Bevacizumab treatment group will be the only group/arm that has values, all other treatment groups/arms will have a null value for this outcome measure.|Baseline to 3 Weeks|||microns||Inter-Quartile Range|Median
155010|NCT00336323|Secondary|Distribution of Change in Visual Acuity Over All Study Visits|Visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; an increase in a letter score by 10 is considered clinically significant.|Baseline to 3,6,9, and 12 weeks|||participants|||Number
155011|NCT00336323|Primary|Percentage of Participants With <250 Microns or ≥ 50% Reduction in Retinal Thickening From Baseline Over All Study Visits|Central subfield retinal thickness measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading.|Baseline to 3,6,9, and 12 Weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.||percentage of participants|||Number
155012|NCT00336323|Secondary|Change in Visual Acuity Letter Score From Baseline Over All All Study Visits|Change in visual acuity letter score as measured using an electronic visual acuity testing machine based on the electronic Early Treatment for Diabetic Retinopathy Study(E-ETDRS) technique. At baseline and at each follow up visit, best corrected visual acuity was measured at 3 meters by a certified tester using an electronic procedure based on the E-ETDRS method. Letter score best value = 97 and worst value = 0; positive change represents an improvement in letter score.|Baseline to 3,6,9, and 12 weeks|||letters||Inter-Quartile Range|Median
155013|NCT00336323|Primary|Change in Central Subfield Retinal Thickness From Baseline Over All Study Visits|Change in central subfield retinal thickness from baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center for grading. Negative changes represent a decrease in retinal thickening.|Baseline to 3,6,9, and 12 weeks|The primary analysis included per protocol and intent to treat analysis. The intent to treat analysis included all randomized eyes. The last observation carried forward method was used to impute missing data. The per-protocol analysis was performed including only patients who receive treatment as per the protocol and complete the 9-week exam.||microns||Inter-Quartile Range|Median
155014|NCT00336284|Secondary|Patient Initiated Follow-up|Percentage of total patient initiated inqueries that result in ER or office follow-up visits.|12 months|Only participants with at least one follow-up are included in the analyses||percent of patient initiated follow-ups|||Number
155015|NCT00336284|Secondary|Early Detection of Cardiac Events|Detection time relative to onset of cardiac events (atrial fibrillation, ventricular tachycardia, ventricular fibrillation).|12 months|Only participants with at least one follow-up are included in the analyses.||Days||Full Range|Mean
155016|NCT00336284|Primary|Percent of Participants Experiencing Death, Incidence of Stroke, or Event Requiring Surgical Intervention.|Percentage of participants experiencing death, incidence of stroke, or event(s) requiring surgical intervention. Outcome measure time frame is 12 months.|12 months|Safety Event Rate includes events occuring within 12 months of enrollment for participants with at least 1 follow-up.||Percentage of participants|||Number
155017|NCT00336284|Primary|Home Monitoring Effectiveness|Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.|12 months|Only participants who completed at least one follow-up visit are included in the analyses.||In-office ICD follow-up per patient year||Full Range|Mean
155018|NCT00336232|Primary|Plasma Phylloquinone|Plasma phylloquinone in response to phylloquinone depletion and repletion|2 months|||nmol/L||Standard Deviation|Mean
155347|NCT00330382|Secondary|Relative Percent Change in Serum Neu Protein (ng/ml)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||95% Confidence Interval|Median
155020|NCT00335959|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal.|Patients were assessed for adverse events after pre-operative chemotherapy, after pre-operative chemoradiation and within 14 days of surgery.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
155021|NCT00335777|Primary|Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.|"Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). Pain free is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe)."|2 hours post treatment with study medication|Per protocol population was used in the efficacy analyses. 22 subjects were included, since they treated a migraine early and another migraine late, as defined in the protocol, with study medication.(Cross-over design)||participants|||Number
155022|NCT00335777|Secondary|Use of Rescue Therapy for Each Attack Treated Per Subject||number subjects using rescue used between 2 and 24 hrs after study drug||||||
155023|NCT00335777|Secondary|Subjects Historical Response to Triptan Therapy and Ergot Therapies||baseline||||||
155024|NCT00335777|Secondary|Pain and Associated Symptoms Assessments as Measured at Pre-dose, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose||baseline, 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr. 8 hr, 24 hr||||||
155025|NCT00335777|Secondary|Allodynia Assessments as Performed at Pre-dosing, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose Has Been Adminis||baseline, 15 minutes, 30 min., 1 hr., 1.5 hr, 2 hr, 4 hr, 8 hr, 24 hr||||||
155026|NCT00335725|Secondary|Clinical Pregnancy Rate|clinical pregnancy rate defined as the presence of gestation sac and heart beat.|6 weeks after treatment start|patients who started the FSH treatment||percentage of treated patients|||Number
155027|NCT00335725|Primary|Total Number of Oocytes Retrieved|Total number of oocytes retrieved|10 days after stimulation start|patients who started the stimulation with FSH||oocytes||Standard Deviation|Mean
155028|NCT00335517|Primary|Number of Patients Enrolled and Recieving Injection||0-48 hours postoperatively|||participants|||Number
155029|NCT00335504|Secondary|Adverse Events.|Defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with participation in a study, whether or not related to that participation. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 3.0. Number of adverse events per grade level.|Up to 30 days after completion of study treatment|||adverse events|||Number
155030|NCT00335504|Secondary|Effects on Apoptosis (Caspase-3 Expression).|Tissue is examined by immunohistochemistry for cleaved caspase-3. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.||Percent change of caspase-3||Standard Deviation|Mean
155031|NCT00335504|Secondary|Effects on Proliferation (Ki67 Expression).|Tissue is examined by immunohistochemistry for Ki67. Measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment. Wilcoxon will be used to assess significant differences between the intervention arms.|Up to 6 months|Patients with assay data from baseline and post-intervention biopsy samples of normal-appearing rectal mucosa.||Percent change||Standard Deviation|Mean
155032|NCT00335504|Primary|Percent Change in Number of Rectal Aberrant Cryptic Foci (ACF) as Measured by Magnification Chromoendoscopy|At the Pre-Intervention Evaluation, rectal ACF will be classified with respect to ACF number, crypt number, crypt size, tissue plane, staining intensity, and (optional) lumen shape for each subject. At the Post- Intervention Evaluation, these same parameters will be recorded and incident vs prevalent rectal ACF status will also be recorded. Compare each non-placebo arms versus the placebo arm to screen the three active study agents for possible phase III testing.|6 months|The population used for the analysis is patients having at least 5 rectal ACF and completing both the pre- and post-intervention MCE assessments and using intention to treat principles.||percent change in number of ACF||Standard Deviation|Mean
155033|NCT00335478|Primary|Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.|"If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued.~Complete Response: Resolution of fever and clinical signs/symptoms of infection.~Partial Response: Resolution of fever without resolution of clinical signs of infection."|Within 72 hours of starting daptomycin|||participants|||Number
155034|NCT00335452|Post-Hoc|Occurrence of Stent Thrombosis - Clopidogrel Treatment Regimen Comparison|This includes definite stent thrombosis (confirmed by angiography or evidence of recent thrombus determined at autopsy or by examination of tissue retrieved following thrombectomy) and probable stent thrombosis (unexplained death having occurred after intracoronary stenting or, MI related to acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any obvious cause) after validation by the EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
155035|NCT00335452|Secondary|Occurrence of Major Bleeding - ASA Dose Level Comparison||30 days|The analysis is on the treated patient population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.||participants|||Number
155037|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level||30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
155038|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison||30 days|The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.||participants|||Number
155039|NCT00335452|Secondary|Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison|Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
155040|NCT00335452|Primary|First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison|"The primary endpoint is the first occurrence of any of the following events:~Cardiovascular death (any death with a clear cardiovascular or unknown cause),~Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal)~Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal)~reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC)."|30 days|The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.||participants|||Number
155041|NCT00335322|Secondary|Compare the Safety of Three Strategic Regimens of Initial ART Containing a Fixed Dose Formulation of Tenofovir and Emtricitabine, With Either Efavirenz or Ritonavir Boosted Atazanavir or Zidovudine Plus Abacavir.||144 weeks||||||
155042|NCT00335322|Primary|Time-weighted Mean Change From Baseline Plasma HIV-RNA.||48 weeks|Modified ITT; all randomised pts who started drug||log copies/mL||95% Confidence Interval|Mean
155043|NCT00335283|Secondary|Quality of Life Questionnaire (QOLRAD)|The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
155044|NCT00335283|Secondary|Sino Nasal Outcome Test (SNOT-20)|SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.|Baseline, 8 weeks and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
155045|NCT00335283|Secondary|Rhinosinusitis Outcome Measure(RSOM-31)|RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.|Baseline, 8 weeks, and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
155046|NCT00335283|Primary|Post Nasal Drainage Symptom Response|The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.|8 and 16 weeks|Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data.||Scores on a Scale||Inter-Quartile Range|Median
155047|NCT00335257|Primary|Arterial Thromboembolism (ATE), Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Arterial thromboembolism (ATE) in women using oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP. Cox regression analysis was not carried out. In accordance to the analysis plan, hazard ratios were only to be calculated if a minimum of 5 confirmed events were available in each of the comparison groups.|Within 60 months|Study participants that were not excluded due to protocol violation||participants|||Number
155048|NCT00335257|Primary|Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs|Venous thromboembolism (VTE) hazard ratio for oral contraceptives containing both drospirenone (DRSP) and ethinylestradiol (EE) in a 24-day regimen or any oral contraceptive without DRSP.|Within 60 months|Study participants that were not excluded due to protocol violation||participants|||Number
155049|NCT00335153|Primary|Number of Participants Taking at Least 1 Concomitant Medication During the Study|Concomitant medications include those started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
155276|NCT00330759|Primary|Time to the First On-Study Skeletal-Related Event (Non-Inferiority)|Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.||Days||95% Confidence Interval|Median
155050|NCT00335153|Primary|Number of Participants With Confirmed Cases of Melanoma|A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination or end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.|Screening up to Day 378|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
155051|NCT00335153|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint|The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155052|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state'.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155053|NCT00335153|Secondary|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155054|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155055|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155056|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155064|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155277|NCT00330733|Secondary|Endothelial Dysfunction||8 and 12 weeks||||||
155278|NCT00330733|Secondary|Parameters of Cardiovascular Disease Risk, Including Glucose, Triglycerides, HDL and Blood Pressure||8 and 12 weeks||09/2013||||
155057|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155058|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155059|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155060|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155061|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155062|NCT00335153|Secondary|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson’s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155063|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155065|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155066|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155067|NCT00335153|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155068|NCT00335153|Secondary|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||units on a scale||Standard Deviation|Mean
155069|NCT00335153|Secondary|"Change From Baseline in Average Daily On Time Without Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. On time without troublesome dyskinesia (involuntary muscle movement) is defined as on time without dyskinesia and on time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for on time without troublesome dyskinesia indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||hours||Standard Deviation|Mean
155070|NCT00335153|Secondary|"Change From Baseline in Average Daily Normalized On Time With Troublesome Dyskinesia at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||hours||Standard Deviation|Mean
155071|NCT00335153|Secondary|"Change From Baseline in Average Daily Off Time at Endpoint"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline, Endpoint (last post-baseline visit up to Day 378)|Full Analysis Data Set: participants who had at least 1 post-baseline safety evaluation, a baseline efficacy evaluation, and had data for at least 1 post-baseline assessment of this efficacy measurement during the Post-PEG Long-Term Treatment Period.||hours||Standard Deviation|Mean
155080|NCT00335153|Primary|Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy – With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods|Complications of the infusion device were collected during the PEG-J Surgery and Post-PEG Long-Term Treatment periods. Pump, PEG-J, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
155072|NCT00335153|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint|"The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions regarding issues with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst On time (dyskinesia [involuntary muscle movement])."|Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment at timepoint.||units on a scale||Standard Deviation|Mean
155073|NCT00335153|Primary|Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period|The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.|Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with an assessment at timepoint.||participants|||Number
155074|NCT00335153|Primary|Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded) who had an assessment.||participants|||Number
155075|NCT00335153|Primary|Number of Participants With Sleep Attacks at Baseline|To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. Those participants who reported 1 or more sleep attacks were asked to report the number of sleep attacks they experienced, whether they experienced sleepiness or drowsiness prior to the sleep attack, whether they experienced a 'bad' outcome or problem due to a sleep attack, and if so, how many 'bad' outcomes or problems they experienced.|Baseline|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
155076|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with given assessment.||participants|||Number
155077|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.|up to 56 weeks|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.||participants|||Number
155078|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include aspartate aminotransferase (AST), upper limit of normal (ULN), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), female (f), and male (m).|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.||participants|||Number
155079|NCT00335153|Primary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Potentially clinically significant values for red blood cells (RBCs), hemoglobin, and hematocrit are specified for females (f) and males (m) separately in the category rows.|Screening through Day 378|Post-PEG Safety Data Set: participants who continued to the PEG-J surgery, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded); n=number of participants with assessment.||participants|||Number
155094|NCT00334802|Secondary|Pharmacokinetics - Area Under the Concentration Curve (AUC)|Area under the concentration curve from time zero to infinity.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.||nanograms*hour per milliliter (ng*hr/mL)||Full Range|Geometric Mean
155279|NCT00330733|Secondary|Plasma Levels of a Variety of Inflammatory Proteins||8 and 12 weeks||||||
155280|NCT00330733|Secondary|Glucose Area Under the Curve in These Subjects||3 months||||||
155081|NCT00335153|Primary|Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period|Complications of the infusion device were collected during the NJ Test period. Pump, intestinal tube, NJ tube, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and post-procedural hemorrhage.|NJ Test Period (from 2 to 14 days)|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
155082|NCT00335153|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.|Screening through Day 378 + 30 days|Safety Data Set: participants who were allocated to treatment, had started placement of NJ tube, and had at least 1 post-baseline safety evaluation (only participants lost to follow-up with no post-baseline information were excluded).||participants|||Number
155083|NCT00334958|Secondary|Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase|RRATIO= 100*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase|Baseline, Days 13 to 96|ITT population||RRATIO||Standard Deviation|Mean
155084|NCT00334958|Secondary|Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase|Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.|Days 13 to 96|ITT population||Seizures per 28-days (log-transformed)||Standard Deviation|Mean
155085|NCT00334958|Secondary|Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|ITT population||Percentage of Participants|||Number
155086|NCT00334958|Primary|Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase|There are 2 major categories of seizures in epilepsy: generalized and partial (focal) seizures. The most frequent type is partial onset seizures. For inclusion in this study, participants needed to have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy Classification of Epileptic Seizures. Seizure data was collected via patient diary, which was used to record daily seizure count and type.|Baseline, Days 13 to 96|Intent-to-treat (ITT) population: All randomized subjects who had baseline Patient Seizure Diary data and had at least completed the titration period||Percentage change||Full Range|Median
155087|NCT00334893|Primary|Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From start of treatment to 24 weeks after completion of study treatment|||participants|||Number
155088|NCT00334893|Secondary|Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer|Measured by NCI CTCAE Version 4.0. The 95% confidence intervals should be provided.|From the time of their first treatment with eribulin mesylate||||||
155089|NCT00334815|Secondary|Response Rate (Confirmed or Unconfirmed Partial Response)|Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration|Only patients with measurable disease at baseline were included in the analysis of response. Among 15 patients on the Low Risk stratum, 14 had measureable disease at baseline. Among 11 patients on the High Risk stratum, 10 had measureable disease at baseline.||percentage of participants||95% Confidence Interval|Number
155090|NCT00334815|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Every week, up to 4 years|||Months||95% Confidence Interval|Median
155091|NCT00334815|Secondary|Progression-free Survival|From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.|||Months||95% Confidence Interval|Median
155092|NCT00334815|Primary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to one year|All eligible patients, both low-risk and high-risk strata combined, who received protocol therapy.||Participants|||Number
155093|NCT00334802|Secondary|Pharmacokinetics - Half Life (t½)|Apparent elimination half-life.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.||hours||Full Range|Geometric Mean
155168|NCT00333801|Secondary|Employment Outcomes (Weeks Competitively Employed)|Number of weeks employed for any time in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)||weeks||Standard Deviation|Mean
155095|NCT00334802|Secondary|Pharmacokinetics - Maximum Plasma Concentration (Cmax)|Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.|cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)|Six participants from each dose level (Dose Level 1 and Dose Level 2) were assessed for pharmacokinetic variables.||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
155096|NCT00334802|Secondary|Number of Participants Alive at One Year (1-Year Survival)||baseline to date of death from any cause, evaluated at 1 year|||participants|||Number
155097|NCT00334802|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|baseline to measured progressive disease|||days||Full Range|Median
155098|NCT00334802|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease|||months||Full Range|Median
155099|NCT00334802|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment. Responders are patients with complete response or partial response."|baseline to measured progressive disease|||participants|||Number
155100|NCT00334633|Secondary|Recurrence of BV||12 weeks||||||
155101|NCT00334633|Primary|Cure of Bacterial Vaginosis||one month|ITT||participants|||Number
155102|NCT00334542|Primary|Change in a Panel of Biomarkers (Contralateral Breast Density) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment mammograms for evaluation of breast density were available for 43 participants.||percentage of change||95% Confidence Interval|Median
155103|NCT00334542|Secondary|Prevalence of Akt and p-Akt Activation by Contralateral Core Breast Biopsies||Baseline and week 24||||||
155104|NCT00334542|Secondary|Prevalence of Breast Gene (Estrogen Receptor [ER]-α and ER-β, Cyclin D2, RAR-β, Twist, RASSF1A, and HIN-1) Hypermethylation||Baseline and week 24||||||
155105|NCT00334542|Primary|Change in a Panel of Biomarkers (High-sensitivity C-reactive Protein [hsCRP], Lipid Profile, and Circulating Estrogens) From Baseline||Baseline and week 24|Paired baseline and post-simvastatin treatment fasting lipid samples were available for 47 participants, including 45 women who completed the study and from two who discontinued the drug prior to the completion of the 24–28 weeks of drug, and are integrated in the intention-to-treat analyses||mg/dl||95% Confidence Interval|Median
155106|NCT00334295|Secondary|Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)|Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).|ICF (Baseline) up to 12 months (12 visits)|FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.||units on a scale||95% Confidence Interval|Mean
155107|NCT00334295|Secondary|Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities|number of adverse events|ICF to Last Patient Out (LPO)|||adverse events|||Number
155108|NCT00334295|Secondary|Determination (for ITT Set): Median Survival|median overall survival (OS)|ICF to the date of death|||months||95% Confidence Interval|Median
155109|NCT00334295|Secondary|Time to Progression of Disease (TTP-Time To Progression, for ITT Set)|median TTP|ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)|||months||95% Confidence Interval|Median
155110|NCT00334295|Primary|Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant|Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.|up to 1 year|||participants|||Number
155111|NCT00334282|Secondary|Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants|Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors. Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.|Baseline|Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses.||picograms per milliliter||Standard Deviation|Mean
155112|NCT00334282|Secondary|Plasma Pazopanib Concentrations Before Dosing and at 2, 4, and 8 Hours After Dosing on Day 1 and Week 3|The concentration of pazopanib in the plasma was measured.|Day 1 and Week 3|Subgroup of enrolled participants who agreed to have blood samples collected for analysis of pazopanib in plasma. Data were missing or not collected at Week 3 for 8 participants for whom data were available on Day 1. No samples were collected at Week 3 from 2 participants.||nanograms per milliliter||Full Range|Median
155113|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant’s self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.||points on a scale||Standard Deviation|Mean
155337|NCT00330421|Primary|Incidence of Adverse Events||Up to 1 month||||||
155338|NCT00330421|Primary|Clinical Benefit, Measured by Any Reduction in Tumor Dimensions on CT Scan as Measured by RECIST Criteria||Up to 1 month||||||
155114|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48|The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (<0).|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.||points on a scale||Standard Deviation|Mean
155115|NCT00334282|Secondary|Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 [very poor quality of life] to 7 [excellent quality of life]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.|Baseline and Weeks 6, 12, 18, 24, and 48|Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.||points on a scale||Standard Deviation|Mean
155116|NCT00334282|Secondary|Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator|Time to response is defined as the time from randomization until the first documented evidence of complete response (all detectable tumor has disappeared) or partial response (a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first).|Randomization until CR or PR (assessed for up to 2 years)|ITT Population. Only participants with a complete or partial response were analyzed. Only results for pazopanib are given because there were not enough placebo responders. The different number of participants analyzed is due to differences in clinical judgement, measurement, and the selection of target lesions.||weeks||95% Confidence Interval|Median
155117|NCT00334282|Secondary|Duration of Response|Duration of response is defined as the time from first observation of response until progression of disease or death.|Time from response until progression (up to 2 years)|ITT Population. Only results for pazopanib are given because there were not enough placebo responders.||weeks||95% Confidence Interval|Median
155118|NCT00334282|Secondary|Participants With Complete Response, Partial Response, or 6 Months of Stable Disease|This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a >=20% increase in target lesions. IRC, independent review committee.|Baseline until 6 months post-Baseline or progressive disease|ITT Population||participants|||Number
155119|NCT00334282|Secondary|Overall Response|Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.|Baseline until either response or progression (up to 2 years)|ITT Population||participants|||Number
155120|NCT00334282|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death. The length of this interval was estimated as the date of death minus the date of randomization plus 1 day. Participants who were still alive at the time of analysis were censored.|Randomization until death (up to 2 years)|ITT Population||months||95% Confidence Interval|Median
155121|NCT00334282|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.|Randomization until progression (up to 2 years)|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
155122|NCT00334204|Primary|Need for Blood Transfusion||12|||participants requiring PRBC Transfusion|||Number
155123|NCT00334204|Primary|Hemoglobin/Hematocrit After Biopsy||12 hours|||participants with hematuria|||Number
155124|NCT00334204|Primary|Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy||12 hours|||participants with hematoma|||Number
155125|NCT00334113|Primary|7-Day Physical Activity Recall (PAR)|A self-report measure of minutes of physical activity over the previous 7 days.|six months|Participants analyzed varies from completed participants since the completed number comes from those who stayed in the study through the 12 months (6 months post intervention). In TAU, the number who completed exceeds the number analyzed since 1 participant did not show for the 6 month assessment but did show for the 12 month follow up assessment.||minutes per week||Standard Deviation|Mean
155126|NCT00334074|Secondary|Number of Participants Who Had an Adverse Event While on Treatment With Clofarabine Plus Cytarabine|Patients will be monitored clinically and diagnostically using measures including blood test, bone marrow aspiration and MUGA. Toxicity assessment every week using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be performed.|Up to five months (includes follow up period of 30 days) from the day patient received their first dose of study drug|Intention To Treat||participants; with adverse events|||Number
155339|NCT00330421|Primary|Clinical Benefit as Measured by 50% Reduction in IFP||Baseline to surgery||||||
155340|NCT00330421|Primary|Change in Pericyte Coverage of Endothelial Cells (Alpha-SMA)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment||||||
155127|NCT00334074|Primary|Response Rate (Complete Response [CR] Plus Partial Response [PR]) of Clofarabine Plus Cytarabine in Patients With Relapsed/Refractory AML, Untreated MDS, CML in Blast Phase, or in Selected Untreated Patients With High Risk of Anthracycline Toxicity|"Based on International working group for diagnosis, standardization of response criteria, and treatment outcomes for reporting standards for therapeutic trials in Acute myeloid Leukemia:~Complete Response (CR) was defined as normalization of marrow blasts (< 5%), recovery of normal heamtopoiesis (absolute neutrophil count >1 X 10^9/l, platelet count ≥100 X10^9/l, and absence of peripheral blood blasts, independent of transfusions and growth factor support.~Partial response was defined as blood count recovery as for complete response with the exception of leukemic marrow blasts in the range of 6%-25% or a ≥50% decrease in bone marrow blasts.~Treatment failure was defined as a <25% change in marrow blasts within 30 days of starting therapy"|Proportion of confirmed responses was estimated by the number of patients who achieved a CR or PR, defined as two consecutive evaluations at least 4 weeks apart, divided by the number of eligible participants in the study.|Intent to Treat analysis; per eligible participants enrolled in the study.||participants|||Number
155128|NCT00334061|Secondary|Percentage of Participants With Symptomatic Hemorrhage|All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.|24-Hour Post-Procedure|||Percentage of Participants|||Number
155129|NCT00334061|Secondary|Percentage of Participants With All Cause Mortality||90-Days Post-Treatment|||Percentage of Participants|||Number
155130|NCT00334061|Secondary|Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment|The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.|90-Day|||Percentage of Participants|||Number
155131|NCT00334061|Secondary|Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment|"NIHSS is a 42 point scale to describe the neurological status of the patients:~0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death."|Discharge or 30-Days Post-Procedure|||Percentage of Participants|||Number
155132|NCT00334061|Primary|Percentage of Participants With Device-related and Procedure-related Serious Adverse Events||6-Month Post-Procedure|All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.||Percentage of Participants|||Number
155133|NCT00334061|Primary|Percentage of Participants With Revascularization of the Occluded Target Vessel|"Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System.~TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow."|6-Month Post-Procedure|Intention to Treat||Percentage of Participants|||Number
155134|NCT00333983|Primary|Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment|"The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, & Steglind, 1975; Gladstone, Danells, & Black, 2002).~Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.~The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome."|Baseline to Final Training (6 weeks)|The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.||units on a scale||Standard Deviation|Mean
155135|NCT00333970|Primary|Cognitive Performance|Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).|baseline and 2 months|individuals who were randomized and completed 2 month assessments||units on a scale||Standard Error|Mean
155136|NCT00333879|Secondary|Accuracy in Selecting Appropriate Time to Cross Street|"Subject is able to state when it is safe to cross the street based on traffic on the street beside him accelerating into motion after traffic on the street in front of him coming to a stop. Subject must state is it safe to cross within 5 seconds of the cars on the street beside him accelerating into motion.~The system under test will be considered efficacious if the subject is correct at least 4 out of 5 times. This counts as being efficacious for that one subject."|4 trials over 30 minutes after 30 minutes of training|||participants|||Number
155137|NCT00333879|Primary|Accuracy in Judging Direction of Traffic at Traffic Intersection|"Standing at an intersection subject indicates when traffic is moving left to right and right to left in front of him, versus traffic moving to and away on the street parallel to his path. Subject can respond in only two ways: 1) traffic is moving on the street in front of me, or 2) traffic is moving on the street beside me.~Each trial lasts 5 minutes with a 2 minute and 30 second break between trials. Traffic stops and starts 5 times over the 5 minutes, each time moving in one of two randomly selected directions: 1) left and right in front of the subject, or 2) forward and back along the street beside the subject.~The participant must correctly state the direction of traffic at least 4 out of five times for the equipment under test to be counted as efficacious for presenting accurate 3D sound information to the participant."|4 trials over 30 minutes after 30 minutes of training|Initial pilot study design called for 16 subjects to provide data of significance based on a power analysis. Study terminated at 4 subjects when none of the subjects could identify the location of traffic vehicles when using the intervention across multiple (4) trials.||participants|||Number
155341|NCT00330421|Primary|Change in White Blood Cell Count (WBC)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment||||||
155138|NCT00333866|Secondary|Total Daily Acetaminophen Dose|Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||mg/day||Standard Error|Least Squares Mean
155139|NCT00333866|Secondary|Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14|Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||mm||Standard Error|Least Squares Mean
155140|NCT00333866|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
155141|NCT00333866|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14|MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
155142|NCT00333866|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
155143|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
155144|NCT00333866|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14|FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group, respectively.||Units on a scale||Standard Error|Least Squares Mean
155145|NCT00333866|Secondary|Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n’=participants evaluable for specified category for each arm group.||Units on a scale||Standard Error|Least Squares Mean
155180|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155146|NCT00333866|Secondary|Percentage of Participants With Optimal Sleep Assessed Using MOS-SS|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Percentage of participants|||Number
155147|NCT00333866|Secondary|Change From Baseline in Weekly Mean Sleep Quality Score|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively.||Units on a scale||Standard Error|Least Squares Mean
155148|NCT00333866|Secondary|Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)|Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.|Baseline, Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
155149|NCT00333866|Primary|Patient Global Impression of Change (PGIC)|Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 14|FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
155150|NCT00333866|Primary|Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)|Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.|Baseline, Week 14|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||Units on a scale||Standard Error|Least Squares Mean
155151|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (Second-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. No participants in the imatinib to IFN-a + Ara-C arm were available for testing.||Percentage of participants|||Number
155152|NCT00333840|Secondary|Percentage of Participants With Major Molecular Response (First-line Treatment)|Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of ≤ 0.1% according to the international scale.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
155153|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.||Participants|||Number
155154|NCT00333840|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)|A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant|144 months|Safety Population included all randomized participants who received study drug.||Participants|||Number
155155|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.~Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.||Percentage of participants|||Number
155156|NCT00333840|Secondary|Percentage of Participants With Best Cytogenetic Response (First-line Treatment)|"Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.~Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= > 0 and ≤ 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated."|144 months|Intent-to-treat participants included all randomized participants.||Percentage of participants|||Number
155157|NCT00333840|Secondary|Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)|Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval||Percentage of participants|||Number
155158|NCT00333840|Secondary|Percentage of Participants With Event Free Survival Events (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:~progression to Accelerated Phase (AP) or Blast Crisis (BC)~loss of Complete Hematological Response (CHR)~loss of Major Cytogenic Response (MCyR) confirmed~loss of Major Cytogenic Response (MCyR) unconfirmed~increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)~death (due to any cause when reported as primary reason for discontinuation of treatment).~The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|144 months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
155159|NCT00333840|Secondary|Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)|"Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:~progression to Accelerated Phase (AP) or Blast Crisis (BC)~loss of Complete Hematological Response (CHR)~loss of Major Cytogenetic Response (MCyR) confirmed~loss of Major Cytogenetic Response (MCyR) unconfirmed~increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)~death (due to any cause when reported as primary reason for discontinuation of treatment).~Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment."|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval||Percentage of participants|||Number
155160|NCT00333840|Primary|Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)|Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.|12,24,36,48,60,72,84,96,108,120,132 and 144 months|Intent-to-treat population included all randomized participants. n = number of participants at risk at the beginning of the specific time interval||Percentage of participants|||Number
155161|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score|Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).|Week 8|Intent to Treat||Percentage of Patients|||Number
155162|NCT00333814|Other Pre-specified|Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)|Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Week 8|Intent to Treat||Percentage of Patients|||Number
155163|NCT00333814|Primary|Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero|Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).|Week 8|Intent to Treat||Percentage of Patients|||Number
155164|NCT00333801|Secondary|Employment Outcomes (Total Gross Income From All Sources|total gross income from all sources of work including noncompetitive and competitive jobs|one year|All randomized participants (intent-to-treat)||US dollars||Standard Deviation|Mean
155165|NCT00333801|Secondary|Employment Outcomes (Gross Income Competitive)|total gross income (US dollars) from all competitive wages, salary, commissions|one year|All randomized participants (intent-to-treat)||US dollars||Standard Deviation|Mean
155166|NCT00333801|Secondary|Employment Outcomes (Hours Competitively Employed)|hours employed in a competitive (not set-aside) job|one year|All randomized participants (intent-to-treat)||hours||Standard Deviation|Mean
155167|NCT00333801|Secondary|Employment Outcomes (Days Competitively Employed|Number of days employed in a competitive job (not set-aside job)|one year|All randomized participants (intent-to-treat)||days||Standard Deviation|Mean
155169|NCT00333801|Secondary|PTSD, Depression, Disability Outcomes|Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score – lowest possible raw score) / (possible raw score range)] x 100.|one-year|All randomized participants (intent-to-treat)||units on a scale||Standard Deviation|Mean
155170|NCT00333801|Primary|Obtain Competitive Employment|The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment.|1 calendar year|All randomized participants were included in the analysis (intent-to-treat)||participants|||Number
155171|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
155172|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
155173|NCT00333788|Secondary|Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
155174|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
155175|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
155176|NCT00333788|Secondary|Occurrence of at Least 1 General Concomitant Medication During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||participants|||Number
155177|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155178|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Follow-Up Period|"Follow-up period start the day after the last injection up to 84 days after last injection.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155179|NCT00333788|Secondary|Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn’s Disease During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.~Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155203|NCT00333619|Primary|Pittsburgh Sleep Quality Index|The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 – 21; score > 8 indicates poor sleep quality).|3-month follow-up|||units on a scale; 0-21||Standard Deviation|Mean
155181|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155182|NCT00333788|Secondary|Occurrence of at Least 1 Emergency Room Visit During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155183|NCT00333788|Secondary|Length of Hospital Stays During the Overall Period|Overall period corresponds to both treatment and follow-up periods in C87046.|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||days||Standard Deviation|Mean
155184|NCT00333788|Secondary|Length of Hospital Stays During the Follow-Up Period|Follow-up period starts the day after the last injection up to 84 days after last injection.|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||days||Standard Deviation|Mean
155185|NCT00333788|Secondary|Length of Hospital Stays During the Treatment Period|The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||days||Standard Deviation|Mean
155186|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the During the Overall Period|"Overall period corresponds to both treatment and follow-up periods in C87046.~Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155187|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Follow-Up Period|"Follow-up period starts the day after the last injection up to 84 days after last injection.~Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period."|Maximum 12 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155188|NCT00333788|Secondary|Occurrence of at Least 1 Hospital Stay During the Treatment Period|"The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.~Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period."|Maximum 152 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155189|NCT00333788|Secondary|Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study|"Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)~Loss of response = both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed)."|Maximum 154 weeks|Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581).||days||Full Range|Median
155190|NCT00333788|Secondary|Change From Baseline of Study C87042 (NCT00308581) in Crohn’s Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||score on a scale||Standard Deviation|Mean
155191|NCT00333788|Secondary|Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points~CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects in remission at Last visit."|Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155204|NCT00333437|Secondary|Mean Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)|DLCO was measured before beginning and after completion of study therapy|12 months|||Liters||Standard Deviation|Mean
155205|NCT00333437|Secondary|Mean Change in Six Minute Walk Distance|Comparison of 6-minute walk distance before beginning and after completing study therapy|12 months|||Feet||Standard Deviation|Mean
155206|NCT00333437|Secondary|Change in Shortness of Breath (Self-reported)|Participants reported frequency of shortness of breath experienced with exertion|Baseline, 12 months|||participants|||Number
155192|NCT00333788|Secondary|Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn’s Disease Activity Index (CDAI).~CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects achieving clinical response at Last visit."|Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155193|NCT00333788|Secondary|Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).|"Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).~Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response [CDAI score >150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)] at 2 consecutive visits.~A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.~Results are presented as the percentage of subjects maintaining response at Last visit."|Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]|Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155194|NCT00333788|Primary|Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)|"Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.~Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study."|Maximum 164 weeks|Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.||percentage of participants|||Number
155195|NCT00333775|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.||Months||95% Confidence Interval|Median
155196|NCT00333775|Secondary|Time to Treatment Failure|Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.||months||95% Confidence Interval|Median
155197|NCT00333775|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.|Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline who had a complete response or a partial response were included in the analysis.||Months||95% Confidence Interval|Median
155198|NCT00333775|Secondary|Percentage of Participants With a Complete Response or a Partial Response|Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
155199|NCT00333775|Primary|Progression-free Survival|Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).|Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)|Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.||Months||95% Confidence Interval|Median
155200|NCT00333762|Primary|Time to Complete Trial Wheelchair Course|Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.|Two years|No data was collected.|||||
155201|NCT00333710|Primary|Hepatitis C Virus Knowledge Questionnaire|This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge|pre-treatment, post-treatment|||units on a scale||Standard Deviation|Mean
155202|NCT00333619|Primary|Sleep Efficiency|Average sleep efficiency calculated from 7 days of actigraphy. Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.|3-month follow-up|||percentage of time asleep while in bed||Standard Deviation|Mean
155209|NCT00333359|Secondary|Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity).|Baseline and Weeks 24 and 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Results include only observed cases and do not include early termination values; as such the number of participants analyzed at each week differs from the number of participants in the Baseline characteristics summary.||points on a scale||Standard Deviation|Mean
155210|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||hours||Standard Deviation|Mean
155211|NCT00333359|Secondary|Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores|The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0.|Baseline and Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||percent change||Standard Deviation|Mean
155212|NCT00333359|Secondary|Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||points on a scale||Standard Deviation|Mean
155213|NCT00333359|Secondary|Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit.|Weeks 24 and 52|Safety Population. Results include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||hours||Full Range|Median
155214|NCT00333359|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data|In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM).|Week 52|Safety Population. Results at Week 52 include only Week 52 observed cases and do not include early termination values; as such, the number of participants with data at each time point differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
155215|NCT00333359|Secondary|Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
155216|NCT00333359|Secondary|Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC|"The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse. Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved and improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed at each week differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
155217|NCT00333359|Secondary|Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study."|Weeks 0, 1, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
155348|NCT00330382|Secondary|Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)|100% x (Posttreatment value - pretreatment value)/(pretreatment value)|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||95% Confidence Interval|Median
155218|NCT00333359|Secondary|Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms.|Weeks 0, 1, 4, 12, 24, and 36|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||points on a scale||Standard Deviation|Mean
155219|NCT00333359|Primary|Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC|"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved or improved, respectively."|Weeks 0, 1, 4, 12, 24, 36, and 52|Safety Population. Results at each week include only observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||participants|||Number
155220|NCT00333359|Primary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)|The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.|Baseline and Week 52|Safety Population: all participants who received one dose or any part of one dose of GEn. Week 52 (end of treatment) results included only Week 52 observed cases and do not include early termination values; as such, the number of participants analyzed differs from the number of participants in the Baseline Characteristics summary.||points on a scale||Standard Deviation|Mean
155221|NCT00333229|Secondary|Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months||2 years||||||
155222|NCT00333229|Secondary|Pathologic Fractures During 24 Month||2 years||||||
155223|NCT00333229|Secondary|Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)||2 years||||||
155224|NCT00333229|Secondary|Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months||2 years||||||
155225|NCT00333229|Primary|Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.||24 months|Analysis was not completed as study was not adequately powered due to premature study termination.|||||
155226|NCT00333138|Secondary|Mean Trough Blood Concentrations of FTY720|For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient’s steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.|Month 3 and 6|Pharmacokinetics population included all the patients who had sample collected and analysis was performed||ng/mL||Standard Deviation|Mean
155227|NCT00333138|Secondary|Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients|The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6,12,60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. A patient at risk are those continuing in the study without an event before the specified timepoint The n denotes number of patients at risk."||percentage of participants||95% Confidence Interval|Number
155228|NCT00333138|Secondary|Change From Baseline in Volume of Total T2-weighted Lesions|Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.|Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"||mm^3||Standard Deviation|Mean
155229|NCT00333138|Secondary|Volume of T2-weighted Lesions|Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"||mm^3||Standard Deviation|Mean
155230|NCT00333138|Secondary|Mean Number of New T2-weighted Lesions|New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The n in each category indicates participants with T2 information recorded at specific timepoints"||GD enhanced T2 lesions||Standard Deviation|Mean
155231|NCT00333138|Secondary|Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit|A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Month 6 and 12, 60, last observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during core study were included in the ITT population. The n number of patients with T2 and T1 information recorded at scan"||percentage of paticipants|||Number
155232|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Last observation (Up to 80 months in average)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
155233|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 60 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
155234|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 12 (extension)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
155235|NCT00333138|Secondary|Percentage of Participants Free of T1-weighted Lesions|A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days|Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)|"All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis. The n in each category indicates number of patients wih information recorded at scan"||percentage of participants|||Number
155236|NCT00333138|Primary|Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.|Month 6 (Core)|All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.||GD- enhanced T1 lesions||Standard Deviation|Mean
155237|NCT00332839|Secondary|Changes in Proteinuria|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months||||||
155238|NCT00332839|Secondary|Changes in Cardiovascular Risk|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months||||||
155239|NCT00332839|Secondary|Number of Participants Who Experienced Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths thorughout the prospective and follow-up phases of the study.|12 months|The safety set, which included all randomized participants, comprised the analysis population.||Participants|||Number
155240|NCT00332839|Secondary|Evolution of Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|Baseline, 12 months||||||
155241|NCT00332839|Secondary|Occurrence of Treatment Failures|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months||||||
155242|NCT00332839|Secondary|Biopsy Proven Acute Rejection, Graft Loss, and Death|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months||||||
155243|NCT00332839|Primary|Renal Function|The analysis for this outcome measure was not perfomed because the analyses could not be powered for efficacy due to low recruitment.|12 months||||||
155244|NCT00332722|Secondary|Neck Disability Index (NDI)|Neck Disability Index (range 0-50) is represented as 0-4 no disability, 5-14 mild disability, 15 - 24 moderate disability, 25 - 34 severe disability and >34 (35-50) complete disability.|2 years|||units on a scale||Standard Deviation|Mean
155245|NCT00332722|Primary|Numeric Rating Scale (NRS)|Numeric Rating Scale (range 0-10) is represented as 0 for no pain and 10 for worst pain imaginable.|over 2 years|A sample size of 60 patients for each group was chosen.||units on a scale||Standard Deviation|Mean
155246|NCT00332709|Secondary|Change in Z-Score From Baseline to Month 12|(DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis||Z-Score||Standard Deviation|Mean
155259|NCT00332696|Secondary|Number of Participants With Relief From Obstruction at Day 7 and Day 14|Relief from obstruction is defined by combining restart of stools for at least the previous 3 days, less than 2 episodes of vomiting on average for the previous 4 days and the restarting of flatus (gas generated in the stomach or bowels) for at least the previous 12 hours.|Day 7 and Day 14|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
155247|NCT00332709|Secondary|Change in T-Score From Baseline to Month 12|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline, Month 12|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in this analysis.||T-Score||Standard Deviation|Mean
155248|NCT00332709|Primary|Change in Z Score From Baseline to Month 36|Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA). The Z-Score is the number of standard deviations a patient's BMD differs from the average BMD of their age, sex and ethnicity. A Z-score of less than minus -1.5 raises concern of factors other than aging as contributing to osteoporosis.|Baseline, month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||Z-Score||Standard Deviation|Mean
155249|NCT00332709|Primary|Change in T-score From Baseline to Month 36|BMD measured by DXA (dual energy x-ray absorptiometry) at lumbar spine, L1-L4. The T-Score is a comparison of a patient's BMD to that of a healthy 30 year of the same sex and ethnicity. The criteria of the World Health Organization are Normal is a T-Score of 1.0 or higher. Osteopenia is defined as between - 1.0 and -2.5. Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and half standard deviations below the mean of a 30 year old man/woman.|Baseline and Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy.Participants with observations at both baseline and endpoint were included in the analysis.||T-Score||Standard Deviation|Mean
155250|NCT00332709|Primary|Percent Change in Bone Mineral Density (BMD) From Baseline to Month 36|"Bone Mineral Density is measured by dual energy x-ray absorptiometry (DXA) scan.~ANCOVA model was used in the analysis where: Variable = Baseline, Center, Treatment BMD = (Month 36 BMD-Baseline BMD)/Baseline BMD*100."|Baseline, Month 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||Percent Change in BMD||Standard Deviation|Mean
155251|NCT00332709|Secondary|Median Disease Free Survival (DFS)|Disease Free Survival is measured in days and represents the number of days participants were progression free. Progression free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Median disease free survival is the time when 50% of the patients had a recurrence.|36 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. The median disease free survival was not observed because patients in the combination therapy did not have any recurrences.||Months||95% Confidence Interval|Median
155252|NCT00332709|Secondary|Number of Participants With Any Kind of Fractures, by Visit.|Number of participants with fractures of any type since the last visit|Baseline, Month 6, 12, 18, 24 , 30 and 36|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations from baseline to month 36 were included in this analysis.||Participants|||Number
155253|NCT00332709|Secondary|Change in Bone Mineral Density From Baseline to 12 Months|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|Baseline, 12 months|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||g/cm^2||Standard Deviation|Mean
155254|NCT00332709|Primary|Change in Bone Mineral Density (BMD) From Baseline to Month 36|Change in bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) in lumbar spine (L1-L4). Change calculated by (Month 36 BMD-Baseline BMD)/Baseline BMD*100.|at 36 months as compared to baseline|(ITT) The study population will consist of post menopausal breast cancer patients who have completed 4 to 6 years of adjuvant Tamoxifen therapy after therapy. Participants with observations at both baseline and endpoint were included in the analysis.||Percent||Standard Deviation|Mean
155255|NCT00332696|Secondary|Participant's Quality of Life Using the Edmonton Scale|The Edmonton Scale consisted of 9 items: pain, activity, nausea, depression, anxiety, fatigue, appetite, sensation of well-being and dyspnea (difficult or labored breathing). Participants rated these items on a scale of 0 to 10, with 10 being the worse.|Day 1, Day 7, Day 14, Month 1, Month 2 and Month 3|"Intent-to-treat population consisted of all participants who received at least one dose of study drug. n in each of the categories is the number of participants who had Quality of Life data at that time point."||Scores on a scale||Standard Deviation|Mean
155256|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 3|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 3|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 3.||Participants|||Number
155257|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 2|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|Month 2|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 2.||Participants|||Number
155258|NCT00332696|Secondary|Number of Participants With Recurrence of an Episode of Bowel Obstruction at Month 1|Recurrence of bowel obstruction was confirmed by abdominal X-ray.|1 Month|Participants from the Intent-to-treat population (consisting of all randomized participants who received at least one dose of study drug) for whom data was available at Month 1.||Participants|||Number
155275|NCT00330759|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.|up to 33 months|Full Analysis Set, composed of all randomized participants.||Days||95% Confidence Interval|Median
155260|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 14|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 14.|Day 14|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 14.||Participants|||Number
155261|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 7|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 7.|Day 7|Participants from the Intent-to-treat population consisting of all randomized participants who received study drug and for whom data was available at Day 7.||Participants|||Number
155262|NCT00332696|Secondary|Number of Participants Reporting Scores 0 to 3 on the Nausea Intensity World Heath Organization (WHO) Scale at Day 1|Participants rated their nausea intensity on a scale of 0 to 3, with 3 being the worse. The number of participants with a score of 0, a score of 1, a score of 2 and a score of 3 are presented for Day 1.|Day 1|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
155263|NCT00332696|Secondary|Number of Vomiting Episodes Per Day at Day1, Day 2 and Day 14|The mean number of vomiting episodes per a 24 hour period is presented for Day 1, Day 7 and Day 14.|Day 1, Day 7 and Day 14|"Intent-to-treat population consisted of all randomized participants who received study drug. n in each of the categories is the number of participants with data at the given time point."||Vomiting episodes||Standard Deviation|Mean
155264|NCT00332696|Secondary|Number of Participants With Treatment Success From Day 5 to Day 7|Day 7 treatment success was defined as improvement of symptoms in the previous 2 days (average number of vomiting episodes less than 2 from Day 5, no Nasogastric Tube (NGT) since Day 5 and no anticholinergic agent or withdrawal from trial).|Day 5 to Day 7|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
155265|NCT00332696|Primary|Number of Participants With Treatment Success From Day 10 to Day 13|"Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 [from Day 10 to Day 13] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14.~Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause."|Day 10 to Day 13|Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.||Participants|||Number
155266|NCT00332644|Primary|7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed|Smoking status was assessed both as 7-day point-prevalence abstinence (“Have you smoked at all, even a puff, in the last 7 days?”) and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants’ self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).|6 months post quit date|||participants with<10 ppm exhaled CO|||Number
155267|NCT00332605|Primary|Penn Craving Scale|used to measure cravings to use drugs over the past week. Range of TOTAL scores is 0-30. A lower score indicates a better outcome, while a higher score indicates a worse outcome.|beginning and at each visit until the end of their participation in the study|Reported scores are Mean and standard deviation for Subjects last visit (including last-observation carried forward).||units on a scale||Standard Deviation|Mean
155268|NCT00332579|Primary|Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)|The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity).|K-YBOCS is done at each visit by the investigator.|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).||units on a scale||Standard Deviation|Mean
155269|NCT00332488|Secondary|Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)||Week 24|Intent to Treat: Subjects who stayed on original treatment||percentage of total hemoglobin||Standard Deviation|Mean
155270|NCT00332488|Secondary|Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue|(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)|Baseline to Week 12|Intention to Treat (ITT) Population for patients with available data||Percentage of total hemoglobin||Standard Deviation|Mean
155271|NCT00332488|Primary|Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue||Baseline to Week 12|Intention to Treat (ITT) Population with Last Observation Carried Forward||Percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
155272|NCT00332462|Secondary|Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation|The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.|3 or 6 months after transplantation|Intention-to-treat (ITT) population.||Participants|||Number
155273|NCT00332462|Primary|Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation|Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.|3 months|Intention to treat (ITT) population||Participants|||Number
155274|NCT00330759|Secondary|Time to the First-and-Subsequent On-Study Skeletal-Related Event|"Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE.~This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|up to 33 months|Full Analysis Set, composed of all randomized participants||Events|||Number
155281|NCT00330733|Primary|Change in Systemic Glucose Disposal- Glucose Infusion Rates|Participants were admitted to the Clinical Research Units at 06:00–08:00 hours after an overnight fast. Euglycaemic–hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm−2 min−1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions.|3 months|analysis was performed on all participants with available baseline and final clamp studies||percent change from baseline||95% Confidence Interval|Median
155282|NCT00330668|Secondary|Height SD Score||during the course of the study|||SD score||Standard Deviation|Mean
155283|NCT00330668|Secondary|Height Velocity Standard Deviation (SD) Score||during the course of the study|||SD score||Standard Deviation|Mean
155284|NCT00330668|Secondary|Height Velocities During Subsequent Years of rh IGF-1 Treatment|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after 2, 3 and 5 years of treatment|||cm/year||Standard Deviation|Mean
155285|NCT00330668|Primary|Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|after one year of treatment|||cm/year||Standard Deviation|Mean
155286|NCT00330616|Secondary|Serious Adverse Events||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.||Participants|||Number
155287|NCT00330616|Secondary|Adverse Events (>=5% Incidence)||Baseline through Week 8|Safety population - all subjects who took at least one dose of study medication.||Participants|||Number
155288|NCT00330616|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8|The CGI-S assesses the investigator's impression of the severity of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, Weeks 1, 2, 3, 4, 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
155289|NCT00330616|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Responders|||Number
155290|NCT00330616|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Week 4 and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
155291|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
155292|NCT00330616|Secondary|Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM-D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
155293|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
155294|NCT00330616|Secondary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
155375|NCT00331422|Secondary|Change in Drug Resistance After Neoadjuvant Chemotherapy|As measured by extreme drug resistance assay - Unable to report due to tissue samples being incomplete or unsatisfactory to do laboratory testing.|Day 1 to Time to Surgery (Approximately Week 18)||||||
155295|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Remitters|||Number
155296|NCT00330616|Secondary|Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Remitters are defined as subjects with a HAM D total score of </= 7.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Remitters|||Number
155297|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Responders|||Number
155298|NCT00330616|Secondary|Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill). Responders are defined as subjects that had a decrease of >/= 50% total score on the HAM D.|Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Responders|||Number
155299|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
155300|NCT00330616|Secondary|Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4|The Hamilton Rating Scale for Depression (HAM D)contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 4|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Percentage of Change||Standard Deviation|Mean
155301|NCT00330616|Primary|Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8|The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).|Baseline and Week 8|Full Analysis Set consisted of all subjects in the safety population who had baseline and at least on post-baseline efficacy data and met the objectively-measured major eligibility criteria. Last observation carried forward method for missing data.||Scores on a scale||Standard Deviation|Mean
155302|NCT00330564|Primary|Safety of Sunitinib Administration in Participants With Von Hippel-Lindau Syndrome (VHL)|Safety evaluation = Number of participants with treatment terminating toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0. Early stopping rules applied when treatment terminating toxicity occurred in the first 6 week cycle. Recurring grade 3 toxicity requires dose reduction, with no more than 2 dose reductions permitted. If no improvement after 4 weeks, patient is taken off drug and off study, and the event recorded as treatment terminating toxicity.|12 weeks|Intent to treat once the first dose was taken.||participants|||Number
155303|NCT00330564|Secondary|Number of VHL Lesion Complete + Partial Responses|Response of VHL lesions (number) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) of Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): 20% increase in LD sum and Stable Disease (SD): Insufficient shrinkage to qualify for PR nor increase to qualify for PD. Degree and timing of response in affected organs evaluated in order to determine organ specific kinetics of therapy.|Baseline to 12 months (evaluations at 6 and 12 months)|Secondary end point of efficacy showed response of renal cell carcinomas, which responded better to sunitinib therapy than other VHL related lesions using RECIST measure.||VHL lesion|Participants||Number
155304|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score|Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).||Percent change||95% Confidence Interval|Mean
156483|NCT00323479|Secondary|Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole|X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values|12 months|||Units on scale||Standard Deviation|Mean
155305|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis|Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).||Percent change||95% Confidence Interval|Mean
155306|NCT00332332|Secondary|Percent Change From Baseline to Month 12 in Patient Global Assessment|Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.|Baseline and Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).||Percent change||95% Confidence Interval|Mean
155307|NCT00332332|Primary|Participants With a Status of Mild or Better on Physician Global Assessment at Month 12|The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.|Month 12|Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.||Participants|||Number
155308|NCT00332241|Secondary|Change From Baseline in Body Weight|Adjusted mean change (Week 8 - baseline) in body weight|Week 8|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Includes all participants with weight measurement at baseline and timepoint. Data set is LOCF.||kilograms||Standard Error|Mean
155309|NCT00332241|Secondary|Summary of Safety|Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation|continuous throughout the study|Safety population=all randomized participants minus 1 patient in the placebo group lost to follow-up. Data set is LOCF.||participants|||Number
155310|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)|A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient’s improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Deviation|Mean
155311|NCT00332241|Secondary|Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores|Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units of a scale||Standard Error|Mean
155312|NCT00332241|Secondary|Mean Change (Week 8 – Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)|CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Error|Mean
155313|NCT00332241|Secondary|Number of Participants With Response at Week 8|Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||participant|||Number
155314|NCT00332241|Secondary|Mean Clinical Global Impressions Improvement Scale (CGI-I) Score|The CGI scale is a clinician-rated global assessment of a patient’s improvement over time. Baseline assessment rated a patient’s condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Error|Mean
155315|NCT00332241|Primary|Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score|The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.|Week 8|Efficacy population=all randomized participants minus 2 patients in the placebo group (1 lost to follow-up, 1 withdrew consent) and 1 participant in the aripiprazole group who discontinued due to AE on Day 2. Data set is LOCF.||units on a scale||Standard Error|Mean
155316|NCT00332189|Secondary|Following Blood Phe Levels.|There were no pre-specified efficacy analysis, blood Phe samples were taken at each visit. Blood Phe concentrations remained within levels consistent with local clinical site recommendations for blood Phe control.|Baseline through Final Visit (a Maximum of 30 months) with blood phe samples taken at months 3 and 6 then at 6 month intervals|The population includes all subjects who received at least one dose of study drug during the study and had at least one measurement of blood Phe level.||micromoles per liter||Standard Deviation|Mean
155342|NCT00330421|Primary|Change in Interstitial Fluid Pressure (IFP)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment|IFP measurements were obtained in only 6 of 15 patients at baseline. Only 2 of these 6 patients had SD at 28 and 56 days and therefore, second IFP measurements were only obtained in those 2 patients.||mm Hg||Full Range|Mean
155317|NCT00332189|Primary|Tabulation of the Incidence and Frequency of All AEs and SAEs That Occur Throughout the Study.|Safety was assessed with regards to the rate and type of AEs, clinically significant changes to vital signs and/or physical examination findings, and clinically significant changes in laboratory test results.|Baseline through Final Visit (a Maximum of 30 months) with AEs collected at month 3 and 6 then at 6 month intervals|Percentage of total population who experienced an AE or SAE presented here. For full list of SAEs, and AEs experienced with a frequency of greater than 5%, see the Reported Adverse Event section.||percentage of subjects reporting events|||Number
155318|NCT00332163|Secondary|Change From Baseline in Overall Dermatologic Quality of Life Index (DLQI) Score|Skin-related quality of life was assessed using the DLQI. The DLQI questionnaire asks participants to evaluate the degree that their skin condition has affected their quality of life in the last week. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); The DLQI score is calculated by summing the scores for all questions, resulting in a maximum of 30 and a minimum of 0; higher scores indicate a more impaired quality of life.|Baseline and Weeks 2, 3, 4, 5, 6 and 7|Patient Reported Outcomes (PRO) Analysis Set (randomized participants who signed informed consent before protocol-specified procedures, received at least 1 dose of panitumumab, with a non-missing baseline overall DLQI score and who had at least 1 post-baseline non-missing overall DLQI score) with available data at each time point.||units on a scale||Standard Deviation|Mean
155319|NCT00332163|Secondary|Progression-free Survival|Defined as the time from the date of randomization to the first date of observed disease progression or death due to any cause (whichever comes first). Participants who were alive and had not progressed while on study were censored at the date of last progression-free tumor assessment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
155320|NCT00332163|Secondary|Overall Survival|Overall Survival is defined as the time from the date of randomization to the date of death. Participants who did not die while on study or who were lost-to-follow-up were censored at their last contact date. Overall survival was analyzed using all data regardless of whether it was collected during second- or third-line treatment.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
155321|NCT00332163|Secondary|Time to Progression|"Time from the date of randomization to the date of observed disease progression or death due to disease progression. Participants who did not have documented disease progression were censored at the date of last tumor assessment; participants who died for reasons other than disease progression while on study were censored at the date of death. PD: At least a 20% increase in the size of target lesions, recorded since the treatment started, or at least a 25% increase in size of non-target lesions and the lesion(s) measure > 10 mm in one dimension, or the appearance of one or more new lesions.~Time to progression was analyzed using the Kaplan-Meier method. This analysis excludes any data collected during follow-up for participants who began third-line treatment."|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
155322|NCT00332163|Secondary|Time to Treatment Failure|Time-to-treatment failure is defined as the time from the date of randomization to the first date of any of the following events: discontinuation of study therapy due to any reason (except for complete response and curative surgery), progression of disease, or death due to any cause. Participants who did not discontinue, who were still alive, and who did not have disease progression were censored at the date of last contact. Time to treatment failure was analyzed using the Kaplan-Meier method.|From randomization until the end of study; median time on study was 31 weeks and 41 weeks in each treatment group respectively with a maximum time on study of 97 weeks.|Primary Analysis Set||months||95% Confidence Interval|Median
155323|NCT00332163|Secondary|Rate of Disease Control at First Scheduled Assessment|Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Disease control rate is defined as the percentage of participants with a CR, PR or stable disease (SD) at the Week 9/10 assessment visit and a corresponding response (CR or PR) confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. SD: Neither sufficient shrinkage or increase in target lesions to qualify for PR or PD, with no progression of non-target lesions and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who prematurely discontinued without a postbaseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13 or 14 were considered non-responders.||percentage of participants||95% Confidence Interval|Number
155324|NCT00332163|Secondary|Best Overall Response Rate|Best overall response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) while on study. Tumor response was assessed by CT scan or MRI of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified RECIST criteria. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or PD (≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Response was assessed at Weeks 9 and 13 and then every 8 weeks for the Q2W regimen, or at Weeks 10, 14, 22 and then every 9 weeks for the Q3W regimen until the end of treatment; median treatment duration was 13 and 17 weeks in each group respectively.|Primary Analysis Set; participants who prematurely discontinued without a post-baseline tumor assessment or with an observed CR or PR that was not confirmed were considered non-responders.||percentage of participants||95% Confidence Interval|Number
155343|NCT00330421|Primary|Change in Fludeoxyglucose (FDG) Uptake (Maximal Standardized Uptake Value, or SUVmax)|Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.|Baseline to up to 1 month post-treatment||||||
155344|NCT00330382|Secondary|Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months||Baseline to 6 months|The participants whose data are available and complete are included in the analysis.||percentage change||95% Confidence Interval|Median
155325|NCT00332163|Secondary|Response Rate at First Scheduled Assessment|Tumor response was assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen, pelvis, and all other sites of disease. Disease assessments were performed by central review according to the modified response evaluation criteria in solid tumors (RECIST). Response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) at the Week 9/10 assessment visit and a corresponding CR or PR confirmed at the Week 13/14 assessment visit for the Q2W/Q3W regimens. CR: Disappearance of all target and non-target lesions and no new lesions. PR: Either the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD; ≥ 25% increase in lesion size) and no new lesions, or, at least a 30% decrease in the size of target lesions with no progression of existing non-target lesions, and no new lesions.|Week 9 with confirmed response at Week 13 for the FOLFIRI and panitumumab Q2W regimen or at Week 10 with confirmed response at Week 14 for the irinotecan and panitumumab Q3W regimen.|Primary Analysis Set; participants who discontinued prematurely without a post-baseline tumor assessment or with an observed CR or PR at Week 9 or 10 that was not confirmed at Week 13/14 were considered non-responders.||percentage of participants||95% Confidence Interval|Number
155326|NCT00332163|Secondary|Percentage of Participants With Panitumumab Dose Reductions Due to the Specific Skin Toxicities of Interest||6 weeks|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
155327|NCT00332163|Secondary|Time to First Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|Time to the first most severe grade ≥ 2 of all the specific skin-related toxicities of interest was defined as the time from the first dose of panitumumab to the date of the first occurrence of the most severe specific ≥ grade 2 skin toxicity of interest during the 6-week skin treatment period. Participants who did not experience any specific skin-related toxicity of grade ≥ 2 were censored at their last skin toxicity assessment during the 6-week skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set||weeks||95% Confidence Interval|Median
155328|NCT00332163|Secondary|Most Severe Specific Grade 2 or Higher Skin Toxicities of Interest|The percentage of participants with a most severe grade of 2, 3 or 4 specific skin toxicity of interest reported during the 6-week skin treatment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
155329|NCT00332163|Secondary|Time to First Occurrence of Specific Grade 2 or Higher Skin Toxicities of Interest|The time to the first occurrence of specific grade 2 or higher skin toxicities of interest was defined as the time from the first dose of panitumumab to the date of first occurrence of specific ≥ grade 2 skin toxicities of interest. Participants who did not experience specific skin-related toxicities were censored at their last skin toxicity assessment during the skin toxicity assessment period. Skin toxicities were assessed by the study clinician and graded according to the modified CTCAE v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary Analysis Set||weeks||95% Confidence Interval|Median
155330|NCT00332163|Secondary|Percentage of Participants With Any Grade 2 or Higher Skin Toxicity of Any Type During the 6-week Skin Treatment Period|The percentage of participants who developed at least 1 incidence of ≥ grade 2 skin toxicities of any type during the 6-week skin treatment period. Analysis of this endpoint was based on adverse event data associated with the “Skin and Subcutaneous Tissue Disorders” system organ class. Adverse events were graded according to the National Cancer Institute (NCI) CTCAE version 3.0.|6 weeks|Primary Analysis Set||percentage of participants||95% Confidence Interval|Number
155331|NCT00332163|Primary|Percentage of Participants With Specific Grade 2 or Higher Skin Toxicities During the 6-week Skin Treatment Period|Skin toxicities were assessed by the study clinician and graded according to the modified Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0 Dermatology Toxicity Grading criteria, on a scale from Grade 1 (mild) to 4 (life-threatening). The specific skin toxicities of interest were pruritus, acneiform dermatitis, skin desquamation (also described as skin exfoliation), exfoliative dermatitis, paronychia, nail disorder, skin fissures, skin laceration, pruritic rash, pustular rash, skin infection, skin ulceration, and local infection.|6 weeks|Primary analysis set (all randomized participants who provided informed consent before protocol-specific procedures and who received at least 1 dose of panitumumab)||percentage of participants||95% Confidence Interval|Number
155332|NCT00330460|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
155333|NCT00330460|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
155334|NCT00330460|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
155335|NCT00330460|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
155336|NCT00330460|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Randomized subjects who have a nonmissing baseline and at least 1 nonmissing postbaseline evaluation at or prior to month 12. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
155349|NCT00330382|Secondary|Clinical Impression From Photographs|A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, “top photo shows a complete response relative to the bottom photo,” through, “the same degree of disease is shown by top photo and bottom photo,” to “bottom photo shows a complete response relative to the top photo.” Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo.|Baseline to 6 months|The participants who have complete data are analyzed in this outcome measure.||score||Standard Deviation|Mean
155350|NCT00330382|Primary|Number of Participants by Category of Clinical Response at 6 Months|Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease.|6 months|The participants who have complete data are analyzed in this outcome measure.||participants|||Number
155351|NCT00330382|Secondary|The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen|The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word ‘Normal’ on the left and ‘Malignant’ on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from ‘Malignancy’ over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period.|Baselie to 6 months|The participants who have complete data are analyzed in this outcome measure.||score||Standard Deviation|Mean
155352|NCT00330382|Primary|Relative Percent Change in Total Lesion Area After 6 Months on Study|Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.|6 months|The participants who have complete data are analyzed in this outcome measure.||percentage change||Standard Deviation|Mean
155353|NCT00331864|Primary|Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye|"Grade 3 targeted AEs included:~4+ ocular inflammation or 2–3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days~≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection~sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days~new retinal tear or detachment involving the macula~new vitreous hemorrhage >2+ severity not resolving within 14 days~new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea"|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.||Percentage of Participants|||Number
155354|NCT00331864|Secondary|Total Number of Treatments|Total number of treatments administered during the entire treatment period (Month 0 to 11).|Baseline (Month 0) to Month 11|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.||Treatments||Standard Deviation|Mean
155355|NCT00331864|Secondary|Time to the First Retreatment After Month 2|"Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.~Criteria for re-treatment:~a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)~a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)"|Month 2 to Month 11|Intent-to-Treat (ITT) population patients: All patients who received study drug at least once and had at least one post-baseline efficacy assessment. The ANCHOR patients were not included in this analysis.||Months||Inter-Quartile Range|Median
155356|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Micrometers||Standard Deviation|Mean
155357|NCT00331864|Secondary|Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3|Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Micrometers||Standard Deviation|Mean
155376|NCT00331422|Secondary|Clinical Response Based on Serum Cancer Antigen 125 (CA-125) Concentration|Ca-125 serum results compared from baseline to after patient's last treatment. This is a tumor biomarker. A decrease in results indicates a clinical response.|From Baseline to up to 12 weeks (4 courses of therapy)|||Participants|||Number
155358|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.~BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 12|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
155359|NCT00331864|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3|"BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.~BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity."|Baseline and Month 3|Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.||Letters on the ETDRS-like testing charts||Standard Deviation|Mean
155360|NCT00331864|Primary|Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye|Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.|Baseline through end of study (12 month treatment period)|For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.||Percentage of Participants|||Number
155361|NCT00331799|Primary|Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks|CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.|baseline and 8 weeks|||units on a scale||Standard Deviation|Mean
155362|NCT00331760|Secondary|Overall Survival||From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
155363|NCT00331760|Secondary|Disease-free Survival||From registration to date of failure (any tumor recurrence, development of distant metastases or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
155364|NCT00331760|Secondary|Distant Metastases||From registration to date of distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
155365|NCT00331760|Secondary|Local-regional Failure||From registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
155366|NCT00331760|Secondary|Chemotherapy Compliance for Cervical Carcinoma Patients||Chemotherapy treatment is centrally reviewed for quality assurance and compliance.||||||
155367|NCT00331760|Secondary|All Other Adverse Events||From start of treatment to the end of follow-up.||||||
155368|NCT00331760|Secondary|Grade 2+ Bowel Adverse Events (Diarrhea, Enteritis, Fistula, Ileus; Gastrointestinal (GI), Incontinence; Anal, Necrosis; GI, Obstruction; GI, Perforation; GI, Proctitis and Stricture/Stenosis (Including Anastomotic) as Graded by CTCAE v. 3.0)||From the start of treatment to 90 days.||||||
155369|NCT00331760|Primary|Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)|"Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.~For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%."|IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.|All eligible patients.||participants|||Number
155370|NCT00331682|Secondary|Overall Survival|Will be computed using Kaplan-Meier methods.|Between the start of treatment until patient death, assessed up to 2 years|||months||Full Range|Median
155371|NCT00331682|Secondary|Time to Progression|Will be computed using Kaplan-Meier methods.|Between the start of treatment until the criteria for progression are met, assessed up to 2 years|||weeks||Full Range|Median
155372|NCT00331682|Primary|Objective Response Rate as Measured by RECIST Criteria|Objective response rate as measured by RECIST criteria|Up to 2 years|||participants|||Number
155373|NCT00331422|Secondary|Quality of Life Score of Patients Receiving Neoadjuvant Chemotherapy|"Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire was used to assess the impact of treatment- and disease-related factors on the quality of life of patients with ovarian cancers undergoing chemotherapy. It is a 5 point scale (from worse to best: 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much responses). Physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns questions are asked.~Unable to evaluate; patients did not consistently complete the questionnaires."|Day 1, Week 12 (after 4th course) , Week 16 (4 weeks after last treatment)||||||
155374|NCT00331422|Secondary|Change in Thrombospondin-1 (TSP-1), p53, and Tumor Vessel Density|Unable to report due to incomplete (nonviable) or unsatisfactory tissue samples.|Week 18 (At surgery)||||||
156484|NCT00323479|Secondary|Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole|Results are based on 97 patients due to missing values|12 months|||Ng/mL||Standard Deviation|Mean
155377|NCT00331422|Secondary|Patients' Overall Tumor Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Best response recorded from start of treatment until after 4th cycle of treatment. Defined by the sum of Complete Responses (CR), Partial Responses (PR), and Stable Disease (SD) in patients neoadjuvant chemotherapy. CR=disappearance of all lesions, PR=>or=30% decrease in sumof all target lesins, Progressive Disease (PD) =>or =20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.|Week 16 (4 weeks after 4th course)|||Participants|||Number
155378|NCT00331422|Primary|Number of Patients Who Underwent Optimal Cytoreduction After Chemotherapy|These patients had their tumor(s) removed by surgery after receiving 4 cycles of chemotherapy to determine their response.|Week 18 (After 4 cycles of chemotherapy)|Includes those patients that received 4 cycles of therapy before removal of cancerous tissue. Evaluation of overall response is not possible due to low number of patients and therefore could not obtain statistical significance.||Participants|||Number
155379|NCT00331409|Secondary|Number of Participants With Adverse Events|"Toxicity assessments will be obtained as follows:~Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles~Safety assessments will consist of evaluating adverse events and serious adverse events."|Duration of study, Up to 4 years|||participants|||Number
155380|NCT00331409|Secondary|Maximum Percent Reduction of Tumor Measurement||Up to 4 years||||||
155381|NCT00331409|Secondary|Median Time to Progression||Time to progression|||months||95% Confidence Interval|Median
155382|NCT00331409|Primary|Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months||Up to 4 years|||participants|||Number
155383|NCT00331409|Primary|Progression-free Survival at 3 Months||3 months post 1st dose|||months||95% Confidence Interval|Median
155384|NCT00331006|Secondary|Proportion of Rituximab Infusions in Which a Reaction to the Infusion Was Reported|Proportion of rituximab infusions in which a reaction to the infusion was reported|Measured at Week 1 through Week 4|All rituximab infusions given to study participants||proportion of rituximab infusions|Participants|95% Confidence Interval|Number
155385|NCT00331006|Secondary|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
155386|NCT00331006|Secondary|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
155387|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
155388|NCT00331006|Secondary|Median Number of Bleeding Events Per Subject Meeting the Criteria of a Serious Adverse Event|Median number of bleeding events per subject meeting the criteria of a serious adverse event|Measured through Week 100|Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.||participants||Inter-Quartile Range|Median
155389|NCT00331006|Secondary|Percent Change in Inhibitor Titer on Challenge With Factor VIII From Baseline Challenge to Post-treatment Challenge|percent change=100%*(A-B)/B where A=inhibitor titer measured within 5-7 days following FVIII rechallenge and B=inhibitor titer measured within 5-14 days following baseline FVIII challenge. A FVIII rechallenge was performed within 10-18 days of the first monthly study visit in which an inhibitor titer result <5 BU/mL was obtained beginning 2 weeks and continuing through 18 weeks following the last rituximab infusion.|Measured within approximately 22 weeks|All subjects who received a post-treatment rechallenge and had at least a minor response.||percentage change||Inter-Quartile Range|Median
155390|NCT00331006|Secondary|Proportion of Subjects With at Least Minor Response, i.e. Inhibitor Level Falls to <5 BU/mL Between Weeks 6-22 and Either Remains <5 BU/mL 5-7 Days Following FVIII Rechallenge or Titer Following FVIII Rechallenge is 5-10 BU/mL & <50% of Original Peak|Presence or absence of at least a minor response in each participant|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab||proportion of participants||95% Confidence Interval|Number
155391|NCT00331006|Primary|Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following Re-challenge With FVIII|Presence or absence of a major response in each participant. Major response is defined as occurring when inhibitor level falls to less than 5 BU/mL between Weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with FVIII|Measured within approximately 22 weeks|All participants who received at least one dose of rituximab||proportion of participants||95% Confidence Interval|Number
155392|NCT00330967|Primary|JNK MAPK Expression With Femoral Lipid and Insulin Infusions|JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
155393|NCT00330967|Primary|Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
155394|NCT00330967|Primary|ERK MAPK Expression With Femoral Lipid and Insulin Infusions|ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
155395|NCT00330967|Primary|Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
155396|NCT00330967|Primary|p38 MAPK Expression With Femoral Lipid and Insulin Infusions|p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
155397|NCT00330967|Primary|Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions|Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions. phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.|4 h|||ratio||Standard Deviation|Mean
155398|NCT00330967|Primary|Insulin Signaling With Lipid Infusion|IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.|4 h|||ratio||Standard Deviation|Mean
155399|NCT00330928|Secondary|Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.|1 year||||||
155400|NCT00330928|Secondary|Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment|Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.|Baseline to 7 day|All patients that were enrolled, intent to treat population, were evaluated for definite or probable relation to the investigational device. This includes 7 subjects that were not exposed to the investigational device.||participants|||Number
155401|NCT00330928|Secondary|Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics||Baseline||||||
155402|NCT00330928|Secondary|Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes|This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.|Baseline||||||
155403|NCT00330928|Primary|Spectral Similarity|Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was >=67%, on a continuous range of 0%(different) to 100%(identical) similarity.|Baseline|58 Subjects were excluded from endpoint analysis for No NIRS data(17), Inadequate data per protocol(11), and Data Accessible during comparison set generation(30).A similarity success was met if >80% of the NIRS data for a subject was similar to the autopsy NIRS set.||percent similarity||95% Confidence Interval|Mean
155404|NCT00330915|Secondary|Number of Participants Receiving Sphincter Saving Surgery||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.||participants|||Number
155405|NCT00330915|Secondary|Number of Participants With Complete Tumor Resection||surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.||participants|||Number
155406|NCT00330915|Secondary|Pathological Complete Response (pCR)|Pathological complete response was defined as the absence of any tumor cells.|surgery following 3 cycles (21-day cycles) of chemotherapy|Number of participants enrolled.||participants|||Number
155407|NCT00330915|Primary|Feasibility of Pemetrexed Prior to Surgery|Feasibility was defined as the ability to receive the total planned dose of Pemetrexed administered over a period of no more than 9 weeks permitting scheduling conflict. A ±5 percent variance in the calculated total dose was allowed.|3 cycles (21-day cycles)|Number of participants enrolled.||participants|||Number
155408|NCT00330876|Secondary|Change From Baseline in Total Cholesterol|Percent change from baseline in total cholesterol (TC)|Baseline to 60 weeks|Subjects with a measurement at Week 60||percent change||Standard Deviation|Mean
155409|NCT00330876|Primary|Change From Baseline in LDL-C|percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|Baseline to 60 weeks|Subjects with measurement at Week 60||percent change||Standard Deviation|Mean
155410|NCT00330174|Secondary|Hospital Anxiety and Depression Scale|This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.|12 weeks|||units on a scale||Standard Error|Mean
155411|NCT00330174|Secondary|Liebowitz Social Anxiety Scale|The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.|12 weeks|||units on a scale||Standard Error|Mean
155412|NCT00330174|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.|12 weeks|||units on a scale||Standard Error|Mean
155413|NCT00330174|Primary|Percent Days Drinking|Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.|12 weeks|The primary outcome measure is difference in cumulative days abstinent. Based on the meta-analysis by Mann et al (2004). A total sample of 90 participants would be able to detect a difference of 11 (+/- 18) days between acamprosate and placebo groups with 80% power, and Type 1 error rate of 0.05.||percentage of days drinking||Standard Error|Mean
155414|NCT00330161|Secondary|Objective Response Rate|Percentage of participants that obtain the best objective response, stable disease.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.||percentage of participants|||Number
155415|NCT00330161|Secondary|Median Survival|Median overall survival.|Up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis. Of the 27 patients analyzed, one patient was censored with an outlying overall survival of 15.1 months.||months||Full Range|Median
155416|NCT00330161|Secondary|Progression-free Survival|Median time to progression was determined.|From the start of treatment to time of progression, assessed up to 3 years|Of the 29 patients enrolled, two patients were deemed ineligible after treatment and therefore excluded from analysis.||months||Full Range|Median
155417|NCT00330161|Secondary|Rate of PSA Decline|Rate of Prostate Specific Antigen (PSA) decline of greater than or equal to 50%.|Up to 3 years|No PSA declines of greater than or equal to 50% were observed, therefore the rate could not be determined.|||||
155418|NCT00330161|Secondary|Incidence of Toxicity|The percentage of eligible participants that experience grade 3 or 4 toxicities.|Up to 3 years|Of the 29 patients enrolled, 2 were deemed ineligible after treatment and therefore excluded from outcome analysis.||percentage of participants|||Number
155419|NCT00330161|Primary|Proportion of Patients Who do Not Demonstrate Disease Progression|Fisher’s Exact Test will be used.|At 6 months|The primary objective was to determine the number of patients wtih progression-free survival at 6 months. Unfortunately all eligible patients were off therapy before the 6 month time point. 13 (48%) were removed due to progression, 11 (41%) secondary to toxicity, and 3 (11%) for other reasons.|||||
155420|NCT00329901|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo|The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.|Throughout the study (Day 1 to Day 181)|This analysis was done on the safety population.||Participants|||Number
155421|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo|Day 1-7 after any vaccination|Analysis was done on the safety population||Participants|||Number
155422|NCT00329901|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.|Day 1-7 after any vaccination|Analysis was done on the safety population||Participants|||Number
155423|NCT00329901|Secondary|Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.~Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
155424|NCT00329901|Secondary|Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Ratios||95% Confidence Interval|Geometric Mean
155425|NCT00329901|Secondary|The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
155426|NCT00329901|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo|"The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.~The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA)."|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
155438|NCT00329836|Primary|Prevalence of Allodynia in Subjects With Cluster Headache|Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.|Allodynia was assessed at the screening visit|N/A. No lost to follow-up or missing data. All enrolled subjects were analyzed||participants|||Number
155427|NCT00329901|Secondary|Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Ratio||95% Confidence Interval|Geometric Mean
155428|NCT00329901|Secondary|Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||IU/mL||95% Confidence Interval|Geometric Mean
155429|NCT00329901|Secondary|Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo|The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.|1 month after vaccination (Day 29)|Analysis was done on per-protocol population.||Percentages of subjects||95% Confidence Interval|Number
155430|NCT00329901|Primary|Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo|"To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of~the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and~the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA)."|1 month after vaccination (Day 29)|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding||Percentages of subjects||95% Confidence Interval|Number
155431|NCT00329849|Secondary|Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS|Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 to 7 postvaccination|Analysis was performed on safety dataset. Groups were sub-divided into 2 to 5 years of age and 6 to 10 years of age.||Number of subjects|||Number
155432|NCT00329849|Secondary|The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS|Day 181|Analysis was performed on the PP dataset for persistence analysis at day 181.||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
155433|NCT00329849|Secondary|Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS|The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.|Day 181|Analysis was performed on PP dataset for persistence analysis at day 181.||Percentage of subjects||95% Confidence Interval|Number
155434|NCT00329849|Secondary|The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.||Geometric Mean Titers||95% Confidence Interval|Geometric Mean
155435|NCT00329849|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.|Day 1 and 29|Analysis was performed on the PP dataset of primary vaccination.||Percentage of subjects||95% Confidence Interval|Number
155436|NCT00329849|Primary|Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination|Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.|Day 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.||Number of subjects|||Number
155437|NCT00329849|Primary|Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine.~Seroresponse was defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8;~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|1 month after vaccination (day 29)|Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan.||Percentage of subjects||95% Confidence Interval|Number
155439|NCT00329784|Secondary|Proportion of Participants With Food Specific IgE Greater Than or Equal to 0/35 kU/L|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific food sensitivity if a blood draw showed specific IgE levels greater than or equal to 0.35 kU/L for selected ingested allergens.|60 months|Intent-to-treat with data available||percentage of participants|||Number
155440|NCT00329784|Secondary|Proportion of Participants With Specific Skin Prick Test Greater Than or Equal to 3mm|At 60 months of age, participants were assessed for potential allergy to selected food allergens. Participants were considered to have a specific sensitivity if a skin prick containing the allergen produced a wheal size measuring greater than or equal to 3 mm.|60 months|Intent-to-treat with data available||percentage of participants|||Number
155441|NCT00329784|Secondary|Proportion of Participants With Rhinitis at 60 Months|At 60 months of age, participants were assessed for rhinitis. Two types of rhinitis were assessed, perennial rhinoconjunctivitis and seasonal rhinoconjunctivitis. Participants were considered to have either type of rhinitis if they showed a sensitization to the allergen and clinical history of rhinoconjunctivitis symptoms experienced either when exposed to the relevant allergen (perennial) or during the relevant season (seasonal).|60 months|Intent-to-treat with rhinitis data available||percentage of participants|||Number
155442|NCT00329784|Secondary|Proportion of Participants With Asthma at 60 Months|At 60 months of age, participants were assessed for asthma. Participants were considered to have asthma if they had a history of cough, wheeze, or shortness of breath that (1) was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months, (2) required one visit to a physician in the previous 24 months, or (3) occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months.|60 months|Intent-to-treat with asthma data available||percentage of participants|||Number
155443|NCT00329784|Secondary|SCORAD at 60 Months|At 60 months of age, participants were assessed for eczema using a modified Scoring Atopic Dermatitis System (SCORAD). This measure was used to detect eczema in children who may not have had access to topical anti-inflammatory medications or whose parents cannot recall or report the severity of their child’s eczema. Eczema is any type of dermatitis or inflammation of the skin. Atopic dermatitis is the most severe and chronic of all types of eczema. The range of the SCORAD is 0-103. A score of 0 indicates no eczema, scores between 0 and 15 indicate mild eczema, scores between 15 and 40 indicate moderate eczema, and scores greater than 40 indicate severe eczema.|60 months|Intent-to-treat with SCORAD data available||units on a scale||Standard Deviation|Mean
155444|NCT00329784|Primary|Proportion of Participants With Peanut Allergy at 60 Months of Age – Both Strata Combined|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat||percentage of participants|||Number
155445|NCT00329784|Primary|Proportion of Participants With Peanut Allergy at 60 Months of Age – by Skin Prick Test Stratum|At 60 months of age, participants were given an oral food challenge Participants regarded as unlikely to be allergic to peanut received 5 g of peanut protein in a single dose. These participants were considered to have a peanut allergy if they experienced any type of reaction following consumption. A double-blind, placebo-controlled food challenge was offered to other participants with a total of 9.4 g of peanut protein administered in increments. These participants were considered to have a peanut allergy if at any point during the dose escalation procedure the participant had a reaction. Participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin-prick test, and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|60 months|Intent-to-treat||percentage of participants|||Number
155446|NCT00329771|Primary|Proportion of Subjects With Allodynia During a Migraine Attack|Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS).|allodynia assessed within 4 hours from onset of migraine head pain|Participants who completed allodynia test||participants|||Number
155447|NCT00329745|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the end of the primary study up to Year 3|||subjects|||Number
155448|NCT00329745|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|"Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample.~Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary."|From Year 2 up to Year 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy.||subjects|||Number
155449|NCT00329732|Secondary|Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes||||||
155450|NCT00329732|Secondary|Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.||30 minutes||||||
155451|NCT00329732|Secondary|Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;||30 minutes||||||
156501|NCT00323310|Primary|The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events||up to 72 hours post dose|Included all dosed patients (safety population).||Participants|||Number
155452|NCT00329732|Primary|Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.||30 minutes|No analysis was done. Study was terminated.|||||
155453|NCT00329719|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to estimate progression-time distributions.|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years|||months||95% Confidence Interval|Median
155454|NCT00329719|Secondary|Objective Response, as Determined by a Neurological Exam, MRI, and/or CT Measurement|The proportion of patients in each response category will be summarized and 90% confidence intervals calculated assuming that the incidence of response is binomially distributed.|Up to 5 years|||proportion of patients||90% Confidence Interval|Number
155455|NCT00329719|Secondary|Overall Survival|The overall survival distribution will be estimated using the method of Kaplan-Meier.|From start of study registration to death due to any cause or until last follow-up, up to 5 years|||months||95% Confidence Interval|Median
155456|NCT00329719|Primary|Progression-free Survival|"The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation.~If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group.~The ‘success’ probability, i.e., 6-month progression-free survival percentage, for each of group 1 and group 3 will be estimated as the number of evaluable patients still alive at 6 months divided by the total number of evaluable patients followed for at least 6 months. Ninety-five percent confidence intervals for the ‘success’ probability will be calculated according to the approach of Duffy and Santner.~Progression is defined as a 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|At 6 months|||Proportion of Successes||95% Confidence Interval|Number
155457|NCT00329641|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during the first cycle of therapy, then prior to each cycle (one cycle = 3 weeks)|Eligible patients who started therapy||Participants with a given type of AE|||Number
155458|NCT00329641|Secondary|6-month Progression-free Survival|Measured from the date of registration to the first of progression or death due to any cause with patients last known to be alive and progression-free censored at the date of last contact|Every 6 weeks for the first 8 cycles of therapy, and then every 9 weeks until disease progression for up to 3 years after registration or until death|||Percent of population||95% Confidence Interval|Number
155459|NCT00329641|Secondary|One-year Overall Survival|Measured from date of registration to study until death due to any caused with observations last known to be alive censored at the date of last contact|Every 6-9 weeks until progression, after progression every six months for first two years and annually thereafter up to 3 for up to 3 years after registration or until death|Eligible patients who received some treatment||Percentage of population||95% Confidence Interval|Number
155460|NCT00329641|Primary|Response Rate (Complete and Partial Response)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 6 weeks for the first 8 cycles of therapy, then every three cycles (9 weeks) until progression|Eligible patients who received some treatment||participants|||Number
155461|NCT00329602|Post-Hoc|Post-hoc Analysis of Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 12 and 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of CGI-I, exploring the variation in treatment effects across center groups by excluding the same two center groups as in the IRLS post-hoc analysis, was conducted. Centers were grouped into five center groups.|Weeks 12 and 26|ITT Population excluding the same two center groups as in the IRLS post-hoc analysis. Analysis is based on the observed cases for each visit.||Number of responders|||Number
155462|NCT00329602|Post-Hoc|Post-hoc Analysis of Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26, Exploring the Impact of Center Group on Treatment Effect|A post-hoc analysis of the primary outcome measure, exploring the variation in treatment effects across center groups by excluding those with the most extreme treatment effects, was conducted. Centers were grouped into five center groups.|Baseline and Weeks 12 and 26|ITT Population excluding the two center groups with the most extreme treatment effects. Analysis is based on the observed cases for each visit.||Points on a scale||Standard Error|Least Squares Mean
155463|NCT00329602|Secondary|Mean Change From Baseline in the IRLS Rating Scale Total Score at Week 67|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4, with 0 representing the absence of a problem and 4 reflecting a very severe problem. The best and worst possible scores are 0 and 40, respectively. The primary assessment was made by calculating the difference in the average score obtained at Baseline with score at Week 67.|Baseline and Week 67|Open-Label ITT Population: all participants who were enrolled into the Open-Label Phase of the study, received at least one dose of Open-Label study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Analysis is based on the observed cases for each visit.||points on a scale||Standard Deviation|Mean
155464|NCT00329602|Primary|Number of Participants With Clinically Meaningful Augmentation and Early Morning Rebound (EMR) Cases|Clinically meaningful augmentation and early morning rebound (EMR) were assessed and confirmed by an independent Adjudication Board. EMR describes the development of RLS symptoms during the early morning, following therapeutic intervention. EMR is differentiated from augmentation, in which the earlier onset of symptoms occurs in the evening.|During 15-month study duration at scheduled (Weeks 16, 20, 26, or early withdrawal for DB phase; Weeks 39, 47, 55, 63, 67, or early withdrawal for the OL phase) and unscheduled (26-week DB phase and 40-week OL phase) visits|Safety Population: all participants who received at least one dose of study medication||participants|||Number
156041|NCT00326716|Primary|Mean ATV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||Hours||95% Confidence Interval|Geometric Mean
155465|NCT00329602|Secondary|Number of Participants With a Score of Much/Very Much Improved on the CGI-I Scale at Week 67|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Week 67|Open-Label (OL) ITT Population: all participants who were enrolled into the OL Phase of the study, received at least one dose of OL study medication, and had a baseline IRLS total score and on-treatment IRLS assessment. Data are presented for participants still in the study and assessed at Week 26, which is less than those randomized at baseline.||participants|||Number
155466|NCT00329602|Secondary|Median Time to First CGI-I Response of Much/Very Much Improved During the Double-blind Phase|The median time to first CGI-I response of much/very much improved was calculated. The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available||days||95% Confidence Interval|Median
155467|NCT00329602|Secondary|Number of Participants Rated as Normal or Borderline Ill on the CGI Severity of Illness (CGI-S) Scale at Week 26|The CGI-S scale is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-S allows the investigator to rate the severity of the participant's illness considering their total clinical experience with the subject population being studied and on all information available at the time of rating. The scale is rated from 1-7 (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severly ill; 7 = among the most extremely ill participants).|Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Data are presented for the participants still in the study and assessed at Week 26, which is less than those randomised at baseline.||participants|||Number
155468|NCT00329602|Secondary|Number of Participants Withdrawing Due to Lack of Efficacy During the First 26 Weeks of the Study|Lack of efficacy is defined as up to a 10% improvement in the IRLS Rating Scale total score from the participant's Baseline value and at least 12 weeks of treatment during the double-blind phase.|Baseline to Week 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available||participants|||Number
155469|NCT00329602|Secondary|Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 1, 12 and 26|The CGI-I is a psychometric instrument that is used to measure general clinical status in a variety of disease states. The CGI-I allows the investigator to rate the participant's global improvement or worsening compared with the condition at Baseline (Day 0). The scale is rated from 1-7 (1 = very much improved; 7 = very much worse). Typically, a participant with a score of 1 or 2 (much improved) is considered a responder.|Weeks 1, 12 and 26|Intention-to-Treat (ITT) Population. Analysis is based on the observed cases for each visit.||percentage of participants|||Number
155470|NCT00329602|Secondary|Change From Baseline in the Domains of the MOS 36-item Short Form Health Survey (SF-36) at Weeks 12 and 26|The MOS SF-36 is a generic QoL instrument measuring functional status and well-being. Positive change from baseline for all domains indicates improvement. For all MOS SF-36 domains, the minimum and maximum scores are 0 and 100, respectively, for the transformed scale. Scores were adjusted for baseline domain score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
155471|NCT00329602|Secondary|Change From Baseline in the Johns Hopkins RLS Quality of Life (RLS QoL) Questionnaire Overall Life Impact Score at Weeks 12 and 26|The Johns Hopkins RLS QoL Questionnaire is a disease-specific instrument that assesses the impact of RLS on the daily life, emotional well-being, social life, and work life of participants. The overall life impact score for the John Hopkins RLS QoL scale ranges from a lowest possible score of 0 to a highest possible score of 100. Higher scores represent better quality of life. Scores were adjusted for baseline RLS Quality of Life score, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
155472|NCT00329602|Secondary|Change From Baseline in Sleep Quantity, a Domain of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale, at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population.Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||hours||Standard Error|Least Squares Mean
155490|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0||Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||ratio||Full Range|Geometric Mean
155473|NCT00329602|Secondary|Change From Baseline in the Domains of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Weeks 12 and 26|The MOS-12 Sleep Scale is a comprehensive battery, which measures specific aspects of sleep in participants that may have varying co-morbidities, and, as a result, is appropriate for a medically diverse participant population. Domain values are presented on a 0-100 scale, where a higher score means a greater degree of the attribute implied by the scale name. Scores were adjusted for baseline MOS sleep scale domain value, treatment group, visit, visit by treatment interaction, and center group.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
155474|NCT00329602|Secondary|Mean Change From Baseline in the International RLS (IRLS) Rating Scale Total Score at Weeks 1, 4, 8, 16, and 20|A 10-item, participant-reported scale covering different RLS symptoms. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. The primary assessment from this study was made by calculating the difference in the average score obtained at Baseline with scores at Weeks 1, 4, 8, 16, and 20. Scores were adjusted for baseline IRLS total score, treatment group, visit, visit by treatment group interaction, and center group.|Baseline and Weeks 1, 4, 8, 16, and 20|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
155475|NCT00329602|Primary|Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26|A 10-item, participant-reported scale covering different symptoms of the condition. Each item is scored from 0 to 4; 0 represents the absence of a problem and 4 reflects a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. A negative change from baseline indicates improvement, and a negative treatment difference indicates a benefit of Ropinirole IR over placebo. The primary assessment was made by calculating the difference in the average score obtained at Baseline with scores at Week 12 and then Week 26.|Baseline and Weeks 12 and 26|Intention-to-Treat (ITT) Population: all randomised participants who received at least one dose of study medication, and for whom at least one valid post-baseline efficacy assessment was available. Analysis is based on the observed cases for each visit.||points on a scale||Standard Error|Least Squares Mean
155476|NCT00329550|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:~an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,~use of rescue therapy, or,~subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here.||subjects|||Number
155477|NCT00329550|Secondary|Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155478|NCT00329550|Secondary|Percentage of Subjects at Week 26 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155479|NCT00329550|Secondary|Percentage of Subjects at Week 24 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155491|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155480|NCT00329550|Secondary|Percentage of Subjects at Week 20 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155481|NCT00329550|Secondary|Percentage of Subjects at Week 16 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155482|NCT00329550|Secondary|Percentage of Subjects at Week 12 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155483|NCT00329550|Secondary|Percentage of Subjects at Week 8 Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155484|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0||Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155485|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0||Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155486|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0||Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155487|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0||Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155488|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0||Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155489|NCT00329550|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0||Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155492|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 26||Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155493|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155494|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155495|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155496|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155497|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||mg/L||Full Range|Geometric Mean
155498|NCT00329550|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155499|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155500|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155501|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155502|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155503|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155504|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155505|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
155506|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155507|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155508|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155509|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155510|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155580|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 16 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155511|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155512|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
155513|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155514|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155515|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155516|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155517|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155518|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155581|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 14 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155519|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
155520|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155521|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155522|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155523|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155524|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155525|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155526|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
155582|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 12 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155527|NCT00329550|Secondary|Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155528|NCT00329550|Secondary|Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155529|NCT00329550|Secondary|Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155530|NCT00329550|Secondary|Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155531|NCT00329550|Secondary|Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155532|NCT00329550|Secondary|Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155533|NCT00329550|Secondary|Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
155534|NCT00329550|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:~time to an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,~time to use of rescue therapy, or,~time to subject withdrawal from the study."|Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 where the number of subjects with disease progression is presented.|||||
155551|NCT00329550|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155535|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155536|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 26|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155537|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 24|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155538|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 20|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155539|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 16|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155540|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 12|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155541|NCT00329550|Secondary|Percentage of Subjects Achieving Remission at Week 8|The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155542|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155595|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 8||Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155543|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155544|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155545|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155546|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155547|NCT00329550|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155548|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155549|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 26|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155550|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 24|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155552|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 16|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155553|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 12|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155554|NCT00329550|Secondary|Change From Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 8|CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].||score on a scale||Standard Deviation|Mean
155555|NCT00329550|Primary|Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 26|CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.|Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.||Percentage of subjects|||Number
155556|NCT00329524|Secondary|Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx|Rating of tinnitus loudness using a scale of 0-100 for|immediately following active and sham TMS|||analog rating||Standard Deviation|Mean
155557|NCT00329524|Secondary|Psychomotor Vigilance|Change in simple auditory reaction time after treatment|Immediately after treatment|per protocol||milliseconds||Standard Deviation|Mean
155558|NCT00329524|Primary|Change in PET Asymmetry Index|Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx|After active treatment week|||ratio||Standard Deviation|Mean
155559|NCT00329433|Secondary|The Incidence of Bleeding in Each Group.||Up to 30 days after surgery||||||
155560|NCT00329433|Secondary|The Incidence of DVTs in Each Group.||7 days after surgery||||||
155561|NCT00329433|Primary|The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.|Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.|30 days after surgery|Intent-to-treat analysis was performed according to initial group assignment.||participants|||Number
155562|NCT00329420|Post-Hoc|Number of Subjects With Disease Progression|"Disease progression is defined as:~an increase from Week 14 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,~use of rescue therapy, or,~subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87048 (NCT00329420). As it was not possible to calculate the time to disease progression (outcome measure 34) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here||subjects|||Number
155563|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155701|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|18 months|FAS||Participants|||Number
155564|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 34|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155565|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 32|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155566|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 28|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155567|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 24|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155568|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 20|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155569|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 16|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155570|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 14|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155596|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 0||Week 0 (relative to the start of the 6-week double-blind main study (N00291668)). 'Week 0' is the Baseline visit in the double-blind main study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155571|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 12|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155572|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 10|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155573|NCT00329420|Secondary|Percentage of Subjects Achieving a Reduction in Crohn’s Disease Activity Index (CDAI) Score of ≥70 Points From Week 0 at Week 8|70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|"Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of Responders to Re-induction, based on the Full Analysis Set. This explanation also details withdrawal or rescue therapy being counted as non-response from that time onwards in that study."||percentage of subjects|||Number
155574|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals) to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155575|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 34 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155576|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 32 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155577|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 28 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155578|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 24 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155579|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 20 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155583|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 10 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155584|NCT00329420|Secondary|Ratio of C-Reactive Protein (CRP) Level at Week 8 to CRP Level at Week 0|The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||ratio||Full Range|Geometric Mean
155585|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)||Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155586|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 34||Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155587|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 32||Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155588|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 28||Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155589|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 24||Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155590|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 20||Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155591|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 16||Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155592|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 14||Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155593|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 12||Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
155594|NCT00329420|Secondary|C-Reactive Protein (CRP) Level at Week 10||Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||mg/L||Full Range|Geometric Mean
156042|NCT00326716|Primary|Mean RTV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set||Hours||95% Confidence Interval|Geometric Mean
155597|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155598|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155599|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155600|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155601|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155602|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155603|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155604|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155605|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155606|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155607|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8|The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155608|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155609|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155610|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155611|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155612|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155613|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155614|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155615|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155616|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155617|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155618|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8|The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155619|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155620|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155621|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155622|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155623|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155624|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155625|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155626|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155627|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155628|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155629|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8|The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155630|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155631|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155632|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155633|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155634|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155635|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155636|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155637|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155638|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155639|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155640|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8|The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155641|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155642|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155643|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155644|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155645|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155646|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155647|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155648|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155649|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155650|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155696|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 36 Months|Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|36 months|FAS||Participants|||Number
155651|NCT00329420|Secondary|Change From Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8|The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420). Subjects who respond to re-induction in the Full Analysis Set with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.||score on a scale||Standard Deviation|Mean
155652|NCT00329420|Secondary|Time to Disease Progression|"Time to disease progression is defined as the earliest of:~time to an increase from Week 14 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI>175 points for at least 2 consecutive visits,~time to use of rescue therapy, or,~time to subject withdrawal from the study."|Week 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see outcome measure 124 where the number of subjects with disease progression is presented.|||||
155653|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155654|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155655|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155656|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155657|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155658|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155659|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155660|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155661|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155662|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155663|NCT00329420|Secondary|Percentage of Subjects Achieving Remission at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.||Percentage of subjects|||Number
155664|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155665|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 32|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155666|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 28|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155667|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155697|NCT00329238|Secondary|DVT at 18 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|18 months|FAS||Participants|||Number
155668|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155669|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155670|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 14|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155671|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155672|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155673|NCT00329420|Secondary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. This also details withdrawal or rescue therapy being counted as non-response in a study from that time onwards in that study.||Percentage of subjects|||Number
155674|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 for Completers or the Withdrawal Visit for Premature Withdrawals)|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155698|NCT00329238|Secondary|Deep Vein Thrombosis (DVT) at 36 Months|Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.|36 months|FAS||Participants|||Number
155699|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 18 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|18 months|FAS||Participants|||Number
155675|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155676|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155677|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155678|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155679|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155680|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155681|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155682|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155700|NCT00329238|Secondary|Composite of Recurrent VTE or All Cause Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.|36 months|FAS||Participants|||Number
157974|NCT00308737|Primary|Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care|Change from Baseline to End of Study in FEV1 by MMRM|Baseline to Month 24|Intention to Treat (ITT)||liters||Standard Deviation|Mean
155683|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 weeks after the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155684|NCT00329420|Secondary|Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8|Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.|Please see under the primary endpoint for explanation of entry into this extension study, C87048 (NCT00329420), and of 26 subjects being in the subgroup of “Responders to Re-induction”, based on the Full Analysis Set. All those in this subgroup with data are included in this summary.||score on a scale||Standard Deviation|Mean
155685|NCT00329420|Primary|Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 34|Crohn's disease activity index (CDAI) responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 weeks after the first visit in this extension study.|Non-responders at Week 6 of main study C87037 (NCT00291668) could enter this extension study, C87048 (NCT00329420). This summary is based on the 26 subjects in the Full Analysis Set (FAS) Population who responded to re-induction at Week 14. Subject withdrawal or use of rescue therapy is counted as non-response from that time onwards in that study.||Percentage of subjects|||Number
155686|NCT00329407|Secondary|Phonetic Portion of the Controlled Word Association Test (COWAT)|Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores|Baseline compared to Week 10|||Number of words||Standard Error|Mean
155687|NCT00329407|Primary|The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method|The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate.|70 days|An ITT approach was used in the analysis. Least squares value for the baseline and 10 week of treatment were compared using a t test with Dunnett-Hsu adjustment. Differences between these means are presented as the result.||Standard Drink (14 g alcohol)||Standard Error|Mean
155688|NCT00329238|Secondary|Number of Participants With Definite Acute Coronary Syndrome (ACS)|All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.|day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination|FAS as treated||participants|||Number
155689|NCT00329238|Secondary|Laboratory Analysis|Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).|18 months + 30 days follow up|FAS as treated||participants|||Number
155690|NCT00329238|Secondary|Number of Participants With Bleeding Events|"MBE (major bleeding event) if it fulfilled at least one of the following criteria~Fatal bleeding~Symptomatic bleeding in a critical area or organ.~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.~Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs~CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria~Spontaneous skin haematoma ≥25 cm2~Spontaneous nose bleed >5 min duration~Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h~Spontaneous rectal bleeding~Gingival bleeding >5 min~Bleeding leading to hospitalisation or requiring surgical treatment~Bleeding leading to a transfusion of <2 units of whole blood or red cells~Any other bleeding event considered clinically relevant by the investigator"|first intake of study drug until 6 days following last intake of study drug|FAS as treated||participants|||Number
155691|NCT00329238|Secondary|Deaths of All Causes at 18 Months|Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|18 months|FAS||Participants|||Number
155692|NCT00329238|Secondary|Deaths of All Causes at 36 Months|Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.|36 months|FAS||Participants|||Number
155693|NCT00329238|Secondary|Deaths Related to VTE at 18 Months|Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|18 months|FAS||Participants|||Number
155694|NCT00329238|Secondary|Deaths Related to VTE at 36 Months|Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.|36 months|FAS||Participants|||Number
155695|NCT00329238|Secondary|Symptomatic Pulmonary Embolism (PE) at 18 Months|Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.|18 months|FAS||Participants|||Number
155702|NCT00329238|Primary|Composite of Recurrent VTE or VTE Death at 36 Months|Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.|36 months|FAS||Participants|||Number
155703|NCT00329160|Secondary|Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points||Baseline - 76Weeks|||Percent change||Standard Deviation|Mean
155704|NCT00329160|Secondary|Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）||Baseline - 76Weeks|||Percent change||Standard Deviation|Mean
155705|NCT00329160|Secondary|Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion|Target Lesion indicates Coronary plaque composition of culprit lesions.|Baseline - 76Weeks|||mg/dL||Standard Deviation|Mean
155706|NCT00329160|Primary|Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)|Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.|Baseline and 76 weeks|||Percent Change||Standard Deviation|Mean
155707|NCT00329108|Secondary|Percentage of Patients With Symptomatic Relapse of Mania and/or Symptomatic Relapse of Depression During the Open Label Phase.||6 months||||||
155708|NCT00329108|Secondary|Percentage of Patients With Clinical Response After 6 Weeks of Double-blind Treatment.||6 weeks||||||
155709|NCT00329108|Secondary|Time to Symptomatic Remission in the Double Blind Phase.||up to 10 weeks||||||
155710|NCT00329108|Secondary|Percentage of Patients With Symptomatic Remission After 4, 6 and 10 Weeks of Treatment and at the End of the Double-blind Phase.||4, 6 and 10 weeks||||||
155711|NCT00329108|Secondary|Change From Baseline in Global Assessment of Functioning Scale Scores, Treatment Satisfaction Questionnaire for Medication, Quality of Life Enjoyment and Satisfaction Questionnaire in the Double Blind Phase.||6 months||||||
155712|NCT00329108|Secondary|Change From Baseline in Clinical Global Impressions Scale for Use in Bipolar Illness Scores; Montgomery Asberg Depression Scale Scores in the Double Blind Phase.||up to 10 weeks||||||
155713|NCT00329108|Primary|Mean Reduction in Young Mania Rating Scale (YMRS) Score During the Double Blind Phase.|YMRS is 11-item instrument with scales between 0 to 4 for 7 items and scales between 0 and 8 for 4 items. 0 is normal and either 4 or 8 is the highest level of abnormal, depending on the item.|4 weeks|Study was terminated due to poor recruitment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||score on scale|||Number
155714|NCT00329030|Secondary|Neutrophil Recovery|Time to neutrophil recovery will be the first of two consecutive days of > 500 neutrophils/μL following the expected nadir.|Day 28 and Day 60|||percentage of participants||95% Confidence Interval|Number
155715|NCT00329030|Secondary|Treatment-related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
155716|NCT00329030|Secondary|Immune Reconstitution of Quantitative Immunoglobulins|Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.|1 year|||mg/dL||Standard Deviation|Mean
155717|NCT00329030|Secondary|Immune Reconstitution|Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.|1 year|||cells/uL||Standard Deviation|Mean
155718|NCT00329030|Secondary|Mucositis Severity|Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.|Day 21|||scores on a scale||Full Range|Median
155719|NCT00329030|Secondary|Incidence of Infection||1 year|67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections.||participants|||Number
155720|NCT00329030|Secondary|Hematologic Function|Hematologic function will be defined as ANC > 1,500 neutrophils/μL, hemoglobin > 10 g/dL without transfusion support, and platelet count > 100,000/μL without transfusion support.|100 days, 1 year|||percentage of participants||95% Confidence Interval|Number
155721|NCT00329030|Secondary|Platelet Recovery to 20,000 Cells/μL||100 and 180 days|||percentage of participants||95% Confidence Interval|Number
155722|NCT00329030|Secondary|Complete Response (CR) and Partial Response (PR) Proportion||Day 100 and 2 years|||percentage of participants||95% Confidence Interval|Number
155723|NCT00329030|Secondary|Incidence of Relapse/Progression|The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
155724|NCT00329030|Secondary|Overall Survival|The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
155725|NCT00329030|Primary|Progression-free Survival (PFS)|Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.|1 and 2 years|||percentage of participants||95% Confidence Interval|Number
155726|NCT00328926|Secondary|Percentage of Participants With Cumulative Ovulation|Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles.|Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days])|ITT population included all participants who were treated to trial treatment.||Percentage of participants|||Number
157975|NCT00308711|Secondary|Days in Hospital for Mother and Neonate|Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.|10 days|||days||Standard Deviation|Mean
155727|NCT00328926|Secondary|Percentage of Participants With Cumulative Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles.|Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])|ITT population included all the participants who received study treatment.||Percentage of participants|||Number
155728|NCT00328926|Primary|Time to Clinical Pregnancy|Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.|Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}])|Intention-to-treat (ITT) population included all the participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.||Days||Full Range|Median
155729|NCT00328861|Secondary|Safety|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11/30/2006 - 7/31/2007|||Participants|||Number
155730|NCT00328861|Primary|Objective Response|Objective response (complete response (CR) or partial response (PR)) is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|very 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.|||Participants|||Number
155731|NCT00328783|Primary|Proportion of Patients With Reduction in Radiation||30 days|||proportion of patients||95% Confidence Interval|Number
155732|NCT00328783|Secondary|Toxicity Monitoring|To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.|30 days post-treatment||||||
155733|NCT00328783|Secondary|Improvement in Normal Tissue Irradiation|To evaluate whether potential improvement in normal tissue irradiation can be predicted from standard simulation films, without subjecting patients to free-breathing plus controlled breathingCT scans|30 days post-treatment||||||
155734|NCT00328783|Secondary|Toxicity Evaluation|To evaluate toxicity of ABC in breast cancer patients receiving adjuvant breast radiotherapy|30 days post-treatment||||||
155735|NCT00328783|Primary|Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues|"To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.~The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose."|At time of radiation|||Gy||95% Confidence Interval|Mean
155736|NCT00328770|Secondary|Sirolimus Toxicity/Intolerance|Sirolimus toxicity/intolerance requiring discontinuation of sirolimus|1 year|||participants|||Number
155737|NCT00328770|Primary|Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant|Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant|1 and 4 years|||percentage of participants|||Number
155738|NCT00328770|Primary|Percentage of Participants Surviving at One and Four Years After Liver Transplant|Percent of Patients Surviving at One & Four years after Liver Transplant was calculated|1 & 4 years|Percentage of patients surviving to 1 and 4 years after liver transplant was calculated for all patients||percentage of participants|||Number
155739|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155740|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean HDL Particle Size|The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation. Least squares means are from are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155741|NCT00328627|Secondary|Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean HDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155742|NCT00328627|Secondary|Change From Baseline to Week 26 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μmol/L||Standard Error|Least Squares Mean
155787|NCT00328627|Secondary|Change From Baseline to Week 26 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
155743|NCT00328627|Secondary|Change From Baseline to Week 12 in HDL Particles|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μmol/L||Standard Error|Least Squares Mean
155744|NCT00328627|Secondary|Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR HDL particles as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μMOL/L||Standard Error|Least Squares Mean
155745|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155746|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean LDL Particle Size|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155747|NCT00328627|Secondary|Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean LDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155748|NCT00328627|Secondary|Change From Baseline to Week 26 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155749|NCT00328627|Secondary|Change From Baseline to Week 12 in LDL Particles|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155750|NCT00328627|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR LDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155751|NCT00328627|Secondary|Change From Baseline to Week 26 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155752|NCT00328627|Secondary|Change From Baseline to Week 12 in IDL Particles|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155753|NCT00328627|Secondary|Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of IDL particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR IDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155754|NCT00328627|Secondary|Change From Baseline to Week 26 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155755|NCT00328627|Secondary|Change From Baseline to Week 12 in Mean VLDL Particle Size|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155756|NCT00328627|Secondary|Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)|"The change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline mean VLDL particle size as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nm||Standard Error|Least Squares Mean
155757|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates"|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155758|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL Particles|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155759|NCT00328627|Secondary|Change From Baseline in VLDL Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155760|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155761|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides|The change from Baseline in VLDL/chylomicron triglyceride levels was assessed by NMR lipid fractionation. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155762|NCT00328627|Secondary|Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)|"The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron triglycerides as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155763|NCT00328627|Secondary|Change From Baseline to Week 26 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155764|NCT00328627|Secondary|Change From Baseline to Week 12 in VLDL / Chylomicron Particles|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
157976|NCT00308711|Secondary|Duration of Stay in Minutes in Labor and Delivery Suite|Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care.|5760 minuts|||minutes||Standard Deviation|Mean
155765|NCT00328627|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)|"The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR VLDL/chylomicron particles as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||nmol/L||Standard Error|Least Squares Mean
155766|NCT00328627|Secondary|Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 26.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155767|NCT00328627|Secondary|Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides|"NMR lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155768|NCT00328627|Secondary|Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)|"Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline NMR total triglycerides as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155769|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155770|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein C-III|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155771|NCT00328627|Secondary|Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)|Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155772|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155773|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein B|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155774|NCT00328627|Secondary|Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein B was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155775|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155776|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A2|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
157977|NCT00308711|Secondary|Minutes to Rupture of Membranes (ROM)|Interval from study drug insertion to ROM.|2880 minutes|||minutes||95% Confidence Interval|Median
155777|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A2 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as continuous covariates.|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155778|NCT00328627|Secondary|Change From Baseline to Week 26 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155779|NCT00328627|Secondary|Change From Baseline to Week 12 in Apolipoprotein A1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155780|NCT00328627|Secondary|Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)|Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155781|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
155782|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
155783|NCT00328627|Secondary|Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)|"The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B).~HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as continuous covariates."|Baseline and Weeks 12 and 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage beta cell function||Standard Error|Least Squares Mean
155784|NCT00328627|Secondary|Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
155785|NCT00328627|Secondary|Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance|"The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater degree of insulin resistance. Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
155786|NCT00328627|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)|"HOMA IR measures insulin resistance based on fasting glucose and insulin measurements:~HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5.~A higher number indicates a greater insulin resistance. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.~Least Squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and HOMA-IR as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||insulin resistance||Standard Error|Least Squares Mean
158058|NCT00308308|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|Baseline to Week 52|Safety population||percentage of participants|||Number
155788|NCT00328627|Secondary|Change From Baseline to Week 20 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
155789|NCT00328627|Secondary|Change From Baseline to Week 12 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
155790|NCT00328627|Secondary|Change From Baseline to Week 8 in Body Weight|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
155791|NCT00328627|Secondary|Change From Baseline in Body Weight Over Time (Grouped Analysis)|Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline weight as continuous covariates.|Baseline and Weeks 8, 12, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||kg||Standard Error|Least Squares Mean
155792|NCT00328627|Secondary|Change From Baseline to Week 26 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
155793|NCT00328627|Secondary|Change From Baseline to Week 12 in Adiponectin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
155794|NCT00328627|Secondary|Change From Baseline in Adiponectin Over Time (Grouped Analysis)|Change from Baseline in adiponectin was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline adiponectin as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||μg/mL||Standard Error|Least Squares Mean
155795|NCT00328627|Secondary|Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/L||Standard Error|Least Squares Mean
155796|NCT00328627|Secondary|Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/L||Standard Error|Least Squares Mean
155797|NCT00328627|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)|"Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline hsCRP as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/L||Standard Error|Least Squares Mean
155798|NCT00328627|Secondary|Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155799|NCT00328627|Secondary|Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155800|NCT00328627|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)|"Change from Baseline in plasminogen activator inhibitor-1 (PAI-1) was assessed at Weeks 12 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as continuous covariates."|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155801|NCT00328627|Secondary|Change From Baseline to Week 26 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
155802|NCT00328627|Secondary|Change From Baseline to Week 12 in Free Fatty Acids|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
155803|NCT00328627|Secondary|Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)|Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as continuous covariates.|Baseline and Weeks 12 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mmol/L||Standard Error|Least Squares Mean
155804|NCT00328627|Secondary|Change From Baseline to Week 26 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155805|NCT00328627|Secondary|Change From Baseline to Week 20 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155806|NCT00328627|Secondary|Change From Baseline to Week 16 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155807|NCT00328627|Secondary|Change From Baseline to Week 12 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155808|NCT00328627|Secondary|Change From Baseline to Week 8 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155809|NCT00328627|Secondary|Change From Baseline to Week 4 in Triglyceride Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155810|NCT00328627|Secondary|Change From Baseline in Triglycerides Over Time (Grouped Analysis)|Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline triglycerides as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155811|NCT00328627|Secondary|Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155812|NCT00328627|Secondary|Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155813|NCT00328627|Secondary|Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155814|NCT00328627|Secondary|Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155815|NCT00328627|Secondary|Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155816|NCT00328627|Secondary|Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155817|NCT00328627|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155818|NCT00328627|Secondary|Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155819|NCT00328627|Secondary|Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155820|NCT00328627|Secondary|Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155821|NCT00328627|Secondary|Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155822|NCT00328627|Secondary|Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155823|NCT00328627|Secondary|Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155824|NCT00328627|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)|"Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155825|NCT00328627|Secondary|Change From Baseline to Week 26 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155826|NCT00328627|Secondary|Change From Baseline to Week 20 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155827|NCT00328627|Secondary|Change From Baseline to Week 16 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155828|NCT00328627|Secondary|Change From Baseline to Week 12 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155829|NCT00328627|Secondary|Change From Baseline to Week 8 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155830|NCT00328627|Secondary|Change From Baseline to Week 4 in Total Cholesterol Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155831|NCT00328627|Secondary|Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)|Change from Baseline in total cholesterol was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155832|NCT00328627|Secondary|Change From Baseline to Week 26 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155833|NCT00328627|Secondary|Change From Baseline to Week 20 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155834|NCT00328627|Secondary|Change From Baseline to Week 16 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155835|NCT00328627|Secondary|Change From Baseline to Week 12 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155836|NCT00328627|Secondary|Change From Baseline to Week 8 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155837|NCT00328627|Secondary|Change From Baseline to Week 4 in C-peptide Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155838|NCT00328627|Secondary|Change From Baseline in C-peptide Over Time (Grouped Analysis)|"C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline C-peptide as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ng/mL||Standard Error|Least Squares Mean
155839|NCT00328627|Secondary|Change From Baseline to Week 26 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
155840|NCT00328627|Secondary|Change From Baseline to Week 20 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
155841|NCT00328627|Secondary|Change From Baseline to Week 16 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
155869|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155842|NCT00328627|Secondary|Change From Baseline to Week 12 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
155843|NCT00328627|Secondary|Change From Baseline to Week 8 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
155844|NCT00328627|Secondary|Change From Baseline to Week 4 in Proinsulin/Insulin Ratio|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL).~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
155845|NCT00328627|Secondary|Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)|"The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||ratio||Standard Error|Least Squares Mean
155846|NCT00328627|Secondary|Change From Baseline to Week 26 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
155847|NCT00328627|Secondary|Change From Baseline to Week 20 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
155848|NCT00328627|Secondary|Change From Baseline to Week 16 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
155849|NCT00328627|Secondary|Change From Baseline to Week 12 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
155850|NCT00328627|Secondary|Change From Baseline to Week 8 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
155851|NCT00328627|Secondary|Change From Baseline to Week 4 in Insulin Levels|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
155852|NCT00328627|Secondary|Change From Baseline in Insulin Over Time (Grouped Analysis)|The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline insulin as continuous covariates.|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||µIU/mL||Standard Error|Least Squares Mean
155853|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
155854|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
155855|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
155856|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
155857|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
155858|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Proinsulin|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline proinsulin as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
155859|NCT00328627|Secondary|Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and proinsulin as continuous covariates."|Baseline and Weeks 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||pmol/L||Standard Error|Least Squares Mean
155860|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155861|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26.|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155862|NCT00328627|Primary|Change From Baseline to Week 26 in HbA1c|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155863|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155864|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155865|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155866|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155867|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%|Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155868|NCT00328627|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Baseline and Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
158059|NCT00308308|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%|Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%|Baseline to Week 52|participants in ITT population with available data||Participants|||Number
155870|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155871|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155872|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 7%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155873|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%|Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155874|NCT00328627|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)|"Clinical response at Week 26 was assessed by the percentage of participants with HbA1c less than or equal to 6.5%.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|Week 26|The full analysis set. Patients who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.||percentage of participants|||Number
155875|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:~After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26|Full analysis set including patients with at least 1 postbaseline visit.||percentage of participants|||Number
155876|NCT00328627|Secondary|Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)|"Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days of the first and analyzed by the central laboratory:~After the Week 1 Visit but prior to the Week 4 Visit: a single fasting plasma glucose ≥300 mg/dL;~From the Week 4 Visit but prior to the Week 8 Visit: a single fasting plasma glucose ≥275 mg/dL;~From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥250 mg/dL;~From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with Baseline HbA1c."|From Week 1 to Week 26.|Full analysis set including patients with at least 1 postbaseline visit. This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone.||percentage of participants|||Number
155877|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.||percentage of participants|||Number
155878|NCT00328627|Secondary|Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)|"Marked hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.10 mmol/L).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone."|From Week 1 to Week 26|Full analysis set including patients with at least one non-missing fasting plasma glucose result in each treatment group.||percentage of participants|||Number
155879|NCT00328627|Secondary|Change From Baseline to Week 26 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155880|NCT00328627|Secondary|Change From Baseline to Week 20 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155881|NCT00328627|Secondary|Change From Baseline to Week 16 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155882|NCT00328627|Secondary|Change From Baseline to Week 12 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
158060|NCT00308308|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52|Change from baseline in fasting plasma glucose at Week 52|Baseline to Week 52|participants in ITT population with available data||mg/dl||Standard Error|Least Squares Mean
155883|NCT00328627|Secondary|Change From Baseline to Week 8 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155884|NCT00328627|Secondary|Change From Baseline to Week 4 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155885|NCT00328627|Secondary|Change From Baseline to Week 2 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 2|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155886|NCT00328627|Secondary|Change From Baseline to Week 1 in Fasting Plasma Glucose|Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates.|Baseline and Week 1|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155887|NCT00328627|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)|"The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26.~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline fasting plasma glucose as covariates."|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||mg/dL||Standard Error|Least Squares Mean
155888|NCT00328627|Secondary|Change From Baseline to Week 20 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 20.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 20|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155889|NCT00328627|Secondary|Change From Baseline to Week 16 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 16. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 16|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward (LOCF) imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155890|NCT00328627|Secondary|Change From Baseline to Week 12 in HbA1c|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 12.~Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates."|Baseline and Week 12|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155891|NCT00328627|Secondary|Change From Baseline to Week 8 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 8. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 8|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155892|NCT00328627|Secondary|Change From Baseline to Week 4 in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at week 4. Least squares means are from an ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|Baseline and Week 4|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155893|NCT00328627|Secondary|Change From Baseline in HbA1c Over Time (Grouped Analysis)|"The change from Baseline to Weeks 4, 8, 12, 16 and 20 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~This analysis compared the groupings of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as class variables, and baseline metformin dose and HbA1c as continuous covariates."|Baseline and Weeks 4, 8, 12, 16 and 20.|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155894|NCT00328627|Primary|Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)|"The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).~The primary analysis compared the groupings (combinations of individual treatment groups) of participants who received the combination of pioglitazone with each dose of alogliptin with the grouping of participants who received pioglitazone alone (Pioglitazone Alone)."|Baseline and Week 26|Full analysis set where Baseline and at least 1 postbaseline assessment were available. Last observation carried forward imputation was utilized.||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
155895|NCT00328614|Primary|Maximum Tolerated Dose of Samarium-153|"To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT).~Dose levels:~Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV~Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose."|5 months (1 month HT, administration of drug, 4 months HT and RT)|||mCi/kg|||Number
155896|NCT00328562|Secondary|Survival From Starting Gefitinib||Baseline to date of expiration|||months||Full Range|Median
155897|NCT00328562|Secondary|Progression-free Survival||Baseline to date of progression|||months||Full Range|Median
155898|NCT00328562|Secondary|Tumor Response|"Definitions of objective tumor response~Complete response - disappearance of all target lesions~Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions~Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started"|Baseline, 1, 3, and 5 months post-treatment|||participants|||Number
155899|NCT00328562|Primary|Patients Affected by Treatment-related Morbidities|"See Adverse Events section for specific toxicities"|Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy|||participants|||Number
155900|NCT00328510|Primary|Distance From Ideal to Center of GTC Frame and BrainLab Thermoplastic Mask With Respect to Average and Variability|This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.|Measurements taken during SRT|||millimeters|Participants|Standard Deviation|Mean
155901|NCT00328263|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Patients on Antibiotics|Safety was assessed by the incidence of treatment-emerged adverse events, which were reported according to MedDRA 10.1|Up to 40 days||||||
155902|NCT00328263|Secondary|Health Outcome Evaluation Will Look at the Direct Medical Costs and Clinical Outcomes of Alternative Strategies in the Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients||Up to 40 days||||||
155903|NCT00328263|Secondary|Positive Results for Clostridium Difficile (C. Difficile) Toxin A or B in Antibiotic Associated Diarrhea Patients.|Testing for CDAD was performed at the discretion of the treating physician and according to the protocol in place at the study centers. CDAD was defined as an episode of diarrhea and positive results for C. difficile Toxin A or B.|Up to 40 days||||||
155904|NCT00328263|Primary|The Incidence of Antibiotic-associated Diarrhea.|Presence of at least one diarrhea episode within 24 hours.|Up to 40 days|||participants|||Number
155905|NCT00328198|Primary|Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.|up to 44 weeks|Full analysis set. 95% confidence interval calculated using exact binomial method.||percentage of participants||95% Confidence Interval|Number
155906|NCT00328198|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.|up to 18 weeks of treatment plus 45 days|Full analysis set||participants|||Number
155907|NCT00328198|Secondary|Participants With a Minimal Residual Disease (MRD) Status of Negative|MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.|44 weeks|Full analysis set||participants|||Number
155908|NCT00328198|Secondary|Kaplan-Meier Estimates of Overall Survival|Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.|up to 5 years|Full analysis set||months||95% Confidence Interval|Median
155909|NCT00328198|Secondary|Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)|"Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months.~Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Participants who had a complete response or a partial response||months||95% Confidence Interval|Median
155910|NCT00328198|Secondary|Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)|"Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months.~Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology."|up to 5 years|Full analysis set||months||95% Confidence Interval|Median
155911|NCT00328198|Primary|Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|up to 44 weeks|Full analysis set||participants|||Number
155912|NCT00328172|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks|An absolute efficacy response is defined as HbA1c <= 7.0% at 12 weeks. A non-response is defined as HbA1c > 7.0% at 12 weeks.|Baseline, week 12|FAS patients with baseline HbA1c > 7.0%. Non-completers were considered as failure imputation (NCF).||participants|||Number
155913|NCT00328172|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.||mg/dL||Standard Error|Least Squares Mean
155914|NCT00328172|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12|The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.||percent||Standard Error|Least Squares Mean
155915|NCT00328094|Primary|Composite (Myocardial Infarction and CHF)||hospital length of stay|||Number of patients|||Number
155916|NCT00328094|Secondary|Incidence of Wound Infections||postoperative|||participants|||Number
155917|NCT00328042|Secondary|Hepatitis C Knowledge Questionnaire|The measure consists of 15 questions covering Hepatitis C-specific information related to disease self-management. Each correct response is scored as one point, with total scores range from 0 to 15. Higher scores indicate higher levels of Hepatitis C-specific knowledge. There are no subscales.|Base Line, 6 weeks|||units on a scale||Standard Deviation|Mean
155918|NCT00328042|Primary|Quality of Well-being Scale - Self-Administered (QWB-SA)|The QWB-SA is a preference-based measure of health-related quality of life. Scores range from 0 to 1.0, with 0 representing death, and 1.0 representing asymptomatic, optimal functioning. Thus, higher scores indicate higher quality of life.|Base Line, 12 months|||units on a scale||Standard Deviation|Mean
155919|NCT00327717|Secondary|Drop - Out Rate|Number of Participants who dropped out of the study. In the Study drop-out rate is defined as number of participants.|16 weeks|FAS Population||Number of Participants|||Number
155920|NCT00327717|Secondary|Percentage of Seizure-free Participants During Fixed-dose Phase|Percentage of seizure-free participants during fixed-dose phase|16 weeks|FAS Population||Percentage of Participants|||Number
155921|NCT00327717|Secondary|Mean Time to First Seizure (Days)|Mean time to first seizure during fixed dose phase|16 weeks|FAS Population||Days||Standard Deviation|Mean
155922|NCT00327717|Secondary|Mean Percentage of Change in Seizure Free Days||16 weeks|FAS Population||Percent Change||Standard Deviation|Mean
155923|NCT00327717|Secondary|Mean Number of Seizure Free Days|Mean number of seizure free days per 28 day period during fixed dose phase|12 weeks|FAS Population||Days||Standard Deviation|Mean
155924|NCT00327717|Secondary|Responder Rate|Responder rate is defined as percentage of participants with >=50% reduction in seizure frequency from baseline.|Baseline and 16 weeks|FAS Population||Percentage of Participants|||Number
155925|NCT00327717|Secondary|The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)|The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Secondary generalization patients||Percent Change||Standard Deviation|Mean
155926|NCT00327717|Secondary|The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency|The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS Population. Simple partial seizure patients||Percent Change||Standard Deviation|Mean
155927|NCT00327717|Secondary|The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency|The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.|Baseline and 16 weeks|FAS population. Complex partial seizure patients||Percent Change||Standard Deviation|Mean
155928|NCT00327717|Primary|Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase|The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.|Baseline and 16 weeks|Full analysis set (FAS)||Percent Change||Full Range|Median
155929|NCT00327470|Secondary|Mean Change in Euro QoL Questionnaire (EQ-5D) Score|The EQ-5D is a validated, standardized QoL instrument assessing general health status based on the preference of a UK general population. It consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute (“no problem”, “some problems” and “extreme problems”). A subject’s responses to these domains were mapped to a corresponding score of the EQ-5D index.|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Scores on a scale||Standard Deviation|Mean
155939|NCT00327444|Primary|Time to Repeat Paracentesis (TRP)|"TRP was defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis.~For participants who did not undergo a postrandomization paracentesis on study, TRP was calculated from randomization to the end of the double-blind treatment period."|From Day 1 up to 6 months from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.||days||Standard Error|Least Squares Mean
155940|NCT00327392|Primary|Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures||2 hours|Number of patients requiring specified types of airway assistance||particpants|||Number
155930|NCT00327470|Secondary|Mean Change in National Eye Institute – Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score|Subject reported vision-related functioning and Quality of Life (QoL) as measured using the 25 item NEI-VFQ-25. Items are grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. A positive change represents an increase in function/health, a negative change represents a decrease in function/health.|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Scores on a scale||Standard Deviation|Mean
155931|NCT00327470|Secondary|Mean Change From Baseline in Contrast Sensitivity|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline through Week 54, Baseline through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Correctly read letters||Standard Deviation|Mean
155932|NCT00327470|Secondary|Mean Change in Reading Speed|For assessment of reading speed, subjects were asked to read a print steadily, without stopping or interruption, at a comfortable pace. On commencing reading, a timer was activated. The timer was stopped when the subject had finished reading all of the words on the chart or at 2 minutes, whichever was sooner. Only the total number of words read correctly was recorded. The time recorded for the reading speed test was the time required for the subject to finish reading all of the words on the chart in minutes and seconds (maximum 2 minutes).|Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Correctly read words per minute||Standard Deviation|Mean
155933|NCT00327470|Secondary|Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions|Near VA was measured with the modified Bailey-Lovie near-word reading charts at a distance of 25 centimeters using a +3.50 reading addition worn over the protocol refraction providing the best-corrected distance VA. The reading charts test the smallest word size identifiable from 0.0 logarithmic of the minimum angle of resolution (logMAR) to 1.6 logMAR. logMAR is the logarithm of the minimum angle of resolution. The ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values >0.00 indicate vision poorer than ideal and values <0.0 indicate vision greater than ideal.|Baseline through Week 54, Baseline through Week 102|MITT LOCF. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.||Scores on a scale||Standard Deviation|Mean
155934|NCT00327470|Secondary|Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey ETDRS charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.|Baseline through Week 102, Week 54 through Week 102|MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.||Scores on a scale||Standard Deviation|Mean
155935|NCT00327470|Primary|Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions|The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters from Baseline, gaining >=0 or >=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.|Baseline through Week 54|The modified intent-to-treat (MITT) population included all subjects in the safety population who had a Baseline distance VA measurement and at least 1 post-Baseline VA measurement. Last observation carried forward (LOCF). Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.||Scores on a scale||Standard Deviation|Mean
155936|NCT00327444|Secondary|Plasma Levels of Free and VEGF-bound Aflibercept|"Free aflibercept and VEGF-bound aflibercept plasma concentrations were measured by separate enzyme-linked immunosorbent assay (ELISA). The limit of quantitation of free aflibercept was 15.6 ng/mL, and of VEGF-bound aflibercept was 43.9 ng/mL.~Peak free aflibercept was estimated at the end of Cycle 1 (C1) administration. The median free and VEGF-bound trough concentrations were determined for each participant beyond Cycle 3 (C3), then mean values were estimated from these median values."|Following every biweekly treatment administration up to 60 days after treatment discontinuation|The analysis was performed using the safety population with evaluable blood samples. 42 participants were evaluated.||μg/mL||Standard Deviation|Mean
155937|NCT00327444|Secondary|60-Day Frequency of Paracentesis (FOP)|60-Day FOP was defined as the total number of paracenteses performed within the first 60 days after randomization during the double blind treatment period.|From Day 1 up to 60 days from randomization|The intent-to-treat (ITT) population - all participants who were randomized in the study.||paracentesis||Standard Error|Least Squares Mean
155938|NCT00327444|Secondary|Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM)|"AIM 4 symptoms (abdominal discomfort, abdominal bloating, abdominal pain, and ability to move normally) are scored from 0 to 5, where higher scores represent worst outcomes. An AIM total score ranges from 0-20.~A plot for (The AIM questionnaire total score - Baseline score) versus time were generated. AIM AUC represents the overall improvement (scored positive) if the area is below the baseline value or worsening (scored negative) if the area is above the baseline. AIM AUC for a participant is the sum of individual areas representing improvement (+) or worsening (-)."|From Day 1 up to 60 days from randomization to the first postrandomization paracentesis|The intent-to-treat (ITT) population - all participants who were randomized in the study, and had evaluable AIM scores.||(units on a 4-symptom scale)*day||Standard Error|Least Squares Mean
158061|NCT00308308|Secondary|Change From Baseline in Weight to Week 52|Change from baseline in weight at Week 52|Baseline to Week 52|participants in ITT population with available data||kilogram||Standard Error|Least Squares Mean
155941|NCT00327340|Secondary|Relationship Between Changes in Serum Clusterin Levels and Change in Serum PSA Levels When OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone is Administered as Second Line Chemotherapy.|Serum clusterin samples were collected prior to receiving OGX-011 loading dose 1, prior to study treatment on Day 1 of each cycle, and at the end of treatment. PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit, and during off-treatment follow-up. PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart.|Enrollment until disease progression (up to 13 months)|All 69 subjects were included. Data are presented for the 20 subjects who achieved a 50% decline in PSA (6 subjects who received mitoxantrone and prednisone in combination with OGX-011 and 14 subjects who received docetaxel and prednisone in combination with OGX-011)||percentage of participants|||Number
155942|NCT00327340|Secondary|Feasibility of Treatment With OGX-011 in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second Line Chemotherapy Based on Time to Pain Progression|Time to pain progression was defined as the time (months) from the first dose of OGX-011 to the first documentation of pain or analgesic progression or initiation of palliative radiation therapy. Pain response was defined as either a decrease of at least two points on the 11-point Worst Pain Scale, without an increase in analgesic level, maintained for at least two consecutive measurements approximately three weeks apart –or– a decrease in analgesic level, without an increase in pain score, maintained for at least two consecutive measurements approximately three weeks apart.|Enrollment until pain progression (up to 21 months)|Subjects were evaluable for pain response if they had a baseline Worst Pain Score ≥ 2 or were on opioid analgesics at baseline.||months||95% Confidence Interval|Number
155943|NCT00327340|Secondary|Feasibility of Treatment With Custirsen (OGX-011) in Combination With Second-line Chemotherapy Based on Prostate Specific Antigen (PSA) Response|PSA or prostate specific antigen is a marker for prostate cancer. A PSA response was defined as a decrease in PSA values of ≥ 50% relative to baseline on two or more consecutive measurements that were 4-6 weeks apart.|PSA was evaluated at screening, on Day 1 of each cycle, at the end of treatment visit and during off-treatment follow up (up to 27 months)|"Subjects were evaluable for PSA response if they had baseline PSA and at least two post baseline PSA values.~One subject was not evaluable for PSA response; he had only one post baseline PSA value. A PSA response was defined in the protocol as a decrease in PSA of ≥ 50% relative to baseline on two or more consecutive measurements 4-6 weeks apart."||percentage of participants||95% Confidence Interval|Number
155944|NCT00327340|Primary|Safety and Tolerability of Custirsen (OGX-011) in Combination With Either Docetaxel/Prednisone or Mitoxantrone/Prednisone as Second-line Chemotherapy.|"Safety and tolerability were based on Adverse Events (AE) and Serious Adverse Events (SAE) graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE).~The CTCAE has 5 grades with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1=Mild AE; Grade 2=Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling AE; and Grade 5=Death related to AE."|Subjects were followed for safety from enrollment for up to 8 months (9 three-week cycles plus 30 days after end of treatment)|The total analysis population was 69 subjects: 70 subjects were enrolled; 45 were randomly assigned to treatment (24 to OGX-011/mitoxantrone and 21 to OGX-011 /docetaxel). An additional 25 subjects were assigned to OGX-011/docetaxel. One subject in the mitoxantrone arm was ineligible and did not receive study treatment.||percentage of participants|||Number
155945|NCT00327171|Secondary|Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire|The FACT-O questionnaire consists of 38 scored questions (scored from 0-4) that address physical well-being, social/family well-being, emotional well-being, functional well-being and some additional concerns which relate specifically to ovarian cancer symptoms. For each question, higher scores reflect a better quality of life. The total FACT-O score ranges from 0-152, with 152 indicating the best outcome.|On Day 1 of Cycle 1 (baseline) , and after Day 14 of Cycle 2|All randomized participants who had evaluable FACT-O questionnaires.||score on a scale||Standard Deviation|Mean
155946|NCT00327171|Secondary|Overall Safety - Number of Participants With Adverse Events (AE)|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 30+/-5 days after treatment discontinuation, or up to recovery or stabilization of a followed-up adverse event|Safety population: All randomized participants who received at least part of one dose of study treatment.||participants|||Number
155947|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.~Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||participants|||Number
155948|NCT00327171|Secondary|Overall Survival (OS) Time|"OS was the time interval between randomization and the date of death from any cause. OS was estimated using Kaplan-Meier curves~A participant was censored for the OS analysis if the participant were alive during the study. The censoring date was either at the date that the participant was last known to be alive or the date of study cut-off, whichever was earlier."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||weeks|Participants|95% Confidence Interval|Median
158062|NCT00308308|Primary|Compare the Mean Change From Baseline to Week 52 in HbA1c||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF)||Percentage||Standard Error|Least Squares Mean
155949|NCT00327171|Secondary|Progression-free Survival (PFS) Time Based on Analysis by the IRC|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier. PFS was estimated using Kaplan-Meier curves.~For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||weeks|Participants|95% Confidence Interval|Median
155950|NCT00327171|Secondary|Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC.|"PFS was as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST or death from any cause, whichever was earlier.~The number of participants with tumor/disease progression are reported. Participants who did not reach tumor progression during study, or had no valid post-baseline tumor burden assessment due to early termination, were censored in the PFS analysis."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||participants|||Number
155951|NCT00327171|Secondary|Time to Tumor Marker (CA-125) Progression (TTMP)|"TTMP was the time interval from the date of randomization to the date of tumor marker progression as was defined by GCIG for the evaluable participants. TTMP was estimated using Kaplan-Meier curves.~For a participant who did not reach tumor marker progression (TMP) during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Participants with a valid assessment of CA-125 (requiring at least one pretreatment sample and 2 post-treatment samples).||weeks|Participants|95% Confidence Interval|Median
155952|NCT00327171|Secondary|Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC|"TTP was defined as the time interval measured from the date of randomization to the date of tumor progression as determined by RECIST. TTP was estimated from Kaplan-Meier curves.~For a participant who did not reach tumor progression during study, the censoring date was the date of the last valid tumor burden assessment or the date of study cut-off, whichever was earlier. If the participant had no valid post-baseline tumor burden assessment due to early termination, the censoring date was the date of randomization."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||weeks|Participants|95% Confidence Interval|Median
155953|NCT00327171|Secondary|Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition|TMRR was the proportion of evaluable participants achieving a cancer antigen -125 (CA-125) response based on GCIG definition. A response to CA-125 occurred if after two elevated levels before therapy there was at least a 50% decrease in a post-treatment serum sample, which was confirmed by an independent sample collected 21 days or later that was =< 110% of the post-treatment serum sample.|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Randomized participants who received at least part of one dose of aflibercept, had a baseline tumor assessment, had a valid CA-125 assessment (requiring at least two pretreatment sample and 2 post-treatment samples), did not receive mouse antibodies and had no medical or surgical interference with their peritoneum or pleura in the previous 28 days.||percentage of participants||95% Confidence Interval|Mean
155954|NCT00327171|Secondary|Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC)|"DR was defined as the time interval from the first documentation of CR or PR to the date of tumor progression (or disease progression) as determined by RECIST, or death from any cause, whichever was earlier.~Based on RECIST, progressive disease was at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, the appearance of one or more new target or non-target lesions, or the unequivocal progression of existing non-target lesions."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Efficacy evaluable population: All participants with advanced ovarian epithelial carcinoma who were randomized, underwent baseline tumor assessment, and received at least part of one dose of aflibercept.||days||Standard Deviation|Mean
155955|NCT00327171|Secondary|Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC|"CBR was defined as having a Stable disease (SD) for >= 6 months or a confirmed OR (PR or CR). Based on RECIST:~SD was neither a sufficient shrinkage of the target lesions to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), the persistence of non-target lesions or the maintenance of tumor marker level above the normal limits (for non-target lesions)~CR was the disappearance of all target or non-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.||participants|||Number
155967|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
155988|NCT00326950|Primary|Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)|DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)>/=Grade 3 febrile neutropenia, 3)>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to >/=Grade 3 neutropenia or thrombocytopenia or investigator decision.|3 weeks|||participants|||Number
155956|NCT00327171|Primary|Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort|"OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference.~Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later."|From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)|Simon's cohort: The first 67 evaluable participants, based on Simon’s two-stage design that required 67 evaluable participants per group to maintain a targeted 80% power for Objective response rate versus historical controls.||participants|||Number
155957|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.||Percentage of participants|||Number
155958|NCT00327015|Secondary|Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.||Percentage of participants|||Number
155959|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
155960|NCT00327015|Secondary|Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of Participants|||Number
155961|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
155962|NCT00327015|Primary|Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||percent||Standard Error|Mean
155963|NCT00327015|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
155964|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
155965|NCT00327015|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
155966|NCT00327015|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
158063|NCT00308230|Primary|BNP Levels|Levels of B-type naturietic peptide in the blood|1 day|||pg/ml||Standard Deviation|Mean
155968|NCT00327015|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue.||percent||Standard Error|Mean
155969|NCT00326963|Secondary|Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events|The total number and percentage of participants who discontinued the study medication (ENF) due to clinical adverse events (including clinically significant laboratory abnormalities and AIDS Clinical Trials Group (ACTG) grade≥3 laboratory toxicities) were noted and presented.|Up to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||participants|||Number
155970|NCT00326963|Secondary|Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool.|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Grades 0 through 4 are a measure of intensity, not seriousness. Thus, a grade 3 or grade 4 sign or symptom could be severe, but not necessarily serious. Only active, ongoing ISR were counted. The maximum severity grade for pain/discomfort since the last visit at any injection site was recorded whether or not the maximum severity of pain/discomfort was ongoing at the time of clinical evaluation.|Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up. Maximum number of participants available at the particular time point were analysed and reported.||participants|||Number
155971|NCT00326963|Secondary|Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||Percentage of participants|||Number
155972|NCT00326963|Secondary|Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event|Injection site reactions (ISRs) referred to any localized sign or symptom, including erythema, induration, pruritus, nodules, ecchymosis (degree of bruising/ discoloration), and pain/discomfort. Injection site reactions were monitored by trained study personnel at weeks 1, 4, 12, 16, and 24. Interruption of ENF for toxicity management of recurrent local grade 3 or 4 ISRs until the sign or symptom resolved to grade 2 was at the discretion of the investigator. Any individual injection site signs or symptoms meeting the criteria for a serious adverse event (SAE) had to be reported as an SAE. In the event of a serious ISR, the participant was to immediately discontinue ENF and withdraw from the study. If the participant was not already hospitalized, serious ISRs required a clinic visit within 72 hours of the event.|Week 1 to Week 24|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||participants|||Number
155973|NCT00326963|Secondary|Percentage of Participants Adhering to ENF|Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||Percentage of Participants|||Number
155974|NCT00326963|Secondary|Number of Participants Adhering to Enfuvirtide (ENF)|Adherence to ENF treatment regimen was calculated using the participant’s response to the query on the “Participant Adherence Questionnaire case report form (CRF)” about injections incomplete or missed in the last 4 days preceding the study visit. The percentage adherence to the ENF regimen at each study visit is given by: % Adherence = ([8 - the number of doses missed] / 8) x 100. The number and percentage of participants adhering to the ENF regimen were presented by adherence category (100%, ≥95%, ≥90% and ≥85%) at Weeks 4, 12, and 24.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population.The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||participants|||Number
155985|NCT00326963|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
155986|NCT00326950|Secondary|Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.||3 weeks||||||
155987|NCT00326950|Primary|Maximum Tolerated Dose (MTD)|MTD was the lowest dose at which a dose limiting toxicity occurred.|3 Weeks|||mg/m^2|||Number
155975|NCT00326963|Secondary|Percentage of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of participants|||Number
155976|NCT00326963|Secondary|Number of Participants Meeting Virologic Failure Criteria|The participant was considered as virologic failure at Week 12 clinic visit if patient achieved HIV-RNA <50 copies/mL at Week 4, and HIV-RNA > 50 copies/mL at Week 12, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after Week 12 or if participants failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 at Week 12 and failed to achieve a viral load decrease from baseline greater or equal to 0.5 log10 confirmed at 2 to 4 weeks after Week 12. The participant was considered as virologic failure at Week 24 clinic visit if participant achieved HIV-RNA <50 copies/mL at week 12, and HIV-RNA >50 copies/mL at week 24/early discontinuation, and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation or HIV-RNA >50 copies/mL at any time up to week 24 and HIV-RNA >50 copies/mL confirmed at 2 to 4 weeks after week 24/early discontinuation.|Weeks 12 and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
155977|NCT00326963|Secondary|Change From Baseline in CD4+ Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented . Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at Week X) – (CD4+ count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||cells/mm^3||Standard Deviation|Mean
155978|NCT00326963|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.|Up to Week 28|Analysis was performed on the Safety Population. The Safety Population included all the participants who received at least one dose of trial medication and had a safety follow-up.||participants|||Number
155979|NCT00326963|Secondary|Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load|Summary statistics for change from baseline in plasma HIV-1 RNA count were presented. Change from baseline in plasma HIV-1 RNA count was derived as follows: Change from baseline = (plasma HIV-1 RNA count at Week X) – (plasma HIV-1 RNA count at baseline).|Baseline (Day 1), Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment. Maximum number of participants available at the particular time point were analysed and reported.||copies/mL||Standard Deviation|Mean
155980|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of participants||95% Confidence Interval|Number
155981|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4, Week 12, and Week 24 clinic visit. The number of participants with HIV-1 RNA Viral Load results <400 copies/mL is reported.|Weeks 4, 12, and 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
155982|NCT00326963|Secondary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The percentage of participants with HIV-1 RNA Viral Load results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of Participants||95% Confidence Interval|Number
155983|NCT00326963|Secondary|Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 4 and Week 12 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 4 and 12|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||participants|||Number
155984|NCT00326963|Primary|Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL|Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The percentage of participants with HIV-1 RNA results <50 copies/mL is reported.|Week 24|Analysis was performed on the Intent-to-treat (ITT) Population. The ITT Population included enrolled participants who received at least one dose of study medication and had at least one post baseline efficacy assessment.||Percentage of Participants||97.5% Confidence Interval|Number
155989|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Interference, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Interference question (change from baseline) to Cycle 2 Week 4 is reported. Complete interference is scored as 10 and no interference is scored as 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
155990|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Pain Right Now, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Pain Right Now question (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
155991|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Average Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Average Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain was 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
155992|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using BPI Short Form, Least Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Least Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
155993|NCT00326911|Secondary|Change From Baseline in Assessment of Pain Using the Brief Pain Inventory (BPI) Short Form, Worst Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. Analysis of pain using the BPI was considered exploratory. The Worst Pain (change from baseline) to Cycle 2 Week 4 is reported. The worst pain is 10 and no pain is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
155994|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Legal Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Legal Concerns question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
155995|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Financial Concerns, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Financial Concerns Question question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
155996|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Support, Friends and Family, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Support, Friends and Family question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population||Scores on a scale||Standard Deviation|Mean
155997|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Fatigue, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Fatigue question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population||Scores on a scale||Standard Deviation|Mean
155998|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Severity of Pain, Average, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Severity of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A positive score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population||Scores on a scale||Standard Deviation|Mean
155999|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Frequency of Pain, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Frequency of Pain question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates improvement from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
156010|NCT00326911|Secondary|Overall Survival (OS)|This measure is defined as the time from randomization to the date of death due to any cause. Survival of living patients or those who lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected continuously every 3 months after completion of therapy and/or follow-up (range: 1-19 months).|The overall survival was based on the mITT population.||Months||95% Confidence Interval|Median
156000|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Spiritual Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Spiritual Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up while receiving study drug|mITT population||Scores on a scale||Standard Deviation|Mean
156001|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Level of Social Activity, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Level of Social Activity question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
156002|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Emotional Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Emotional Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT Population||Scores on a scale||Standard Deviation|Mean
156003|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Physical Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Physical Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
156004|NCT00326911|Secondary|Change From Baseline in QoL Assessment Using LASA, Overall Mental Well Being, at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall Mental Well Being question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
156005|NCT00326911|Secondary|Change From Baseline in Quality of Life (QoL) Assessment Using the Linear Analog Scale Assessment (LASA), Overall QoL at Cycle 2 Week 4|Accrual on the trial was stopped earlier than planned due to insufficient efficacy on both arms. The primary analysis of pancreatic cancer symptoms was conducted using the LASA QoL questionnaire and was considered exploratory. The Overall QoL question change from baseline to Cycle 2 Week 4 is reported. The best overall score is 10 and the worst is 0. A negative score indicates worsening from baseline.|Screening, and then every 8 weeks while receiving study drug to 30-day follow-up|mITT population||Scores on a scale||Standard Deviation|Mean
156006|NCT00326911|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Reported AEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for regulatory Activities dictionary. The National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An AE was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|All patients who received any quantity of study therapy were included in the safety evaluation (safety population, as treated).||Participants|||Number
156007|NCT00326911|Secondary|Time to Progression (TTP)|Time to progression was defined as the time from randomization until the date of objectively confirmed tumor progression was first reported. The censoring rule was consistent with PFS except death. Patients who died from any cause were censored at the time of death or at last tumor assessment date if the death date was missing. For patients lost to follow-up, they were censored at the last tumor assessment date.|Time from randomization until the date of objective tumor progression was first reported (range: 11 -38 months)|The TTP was based on the mITT population. For patients lost to follow-up, they were censored at the next scheduled visit.||months||95% Confidence Interval|Median
156008|NCT00326911|Secondary|Percentage of Patients With Carbohydrate Antigen 19-9 (CA19-9) Response at End of Cycle 2 in Patients With Elevated Baseline Values (Equal or Greater Than 2 x Upper Limit of Normal).|CA19-9 is a tumor marker for pancreatic cancer and the level usually increases as the disease is progressing. The CA19-9 response was the percentage of patients whose CA19-9 level was declining, stable or increasing < 10% compared with baseline, divided by the total patients with elevated baseline CA19-9 in that arm.|First day of treatment to the end of Cycle 2, Week 1|The CA19-9 response rate was calculated for at least the 15 patients in each arm of the study at the end of the first two cycles of therapy (8 weeks) in the mITT population who had elevated CA19-9 levels at baseline.||Percentage of participants|||Number
156009|NCT00326911|Secondary|The Number of Patients With a Best Overall Response of Either a Complete Response (CR) or Partial Response (PR)|The best overall response is the number of patients with a best overall response of CR or PR, as classifed by the investigator according to the RECIST guidelines. A CR is the disappearance of all target lesions and a PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor evaluations were performed every 8 weeks while on cetuximab therapy until PD or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The best overall response was based on the mITT population for those patients who either had a CR or PR.||Participants|||Number
156011|NCT00326911|Primary|Progression-free Survival (PFS)|Progression-free survival is the time from randomization until the date of progressive disease (PD) or death from any cause whichever is first reported. Patients who die without a reported prior progression were considered to have progresssed on the day of their death. Patients who did not progress were censored at the day of their last tumor assessment.|Time from randomization to disease progression or death from any cause (Range: 0 -10 months)|The PFS was based on the modified Intent-to-Treat (mITT) population, which included any patient who enrolled, was randomized, and received any quantity of study drug.||months||95% Confidence Interval|Median
156012|NCT00326898|Other Pre-specified|Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0||Assessed every 6 weeks while on treatment and for 30 days after the end of treatment||||||
156013|NCT00326898|Other Pre-specified|The Association Between Scan Frequency and Development of Congestive Heart Failure||Assessed at 3, 6 and 12 months||||||
156014|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form|PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue|Assessed at baseline, 10 weeks and 22 weeks||||||
156015|NCT00326898|Other Pre-specified|Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale||Assessed at baseline, 10 weeks and 22 weeks||||||
156016|NCT00326898|Other Pre-specified|The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
156017|NCT00326898|Other Pre-specified|The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
156018|NCT00326898|Other Pre-specified|The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
156019|NCT00326898|Other Pre-specified|The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
156020|NCT00326898|Other Pre-specified|The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
156021|NCT00326898|Other Pre-specified|The Association Between Angiogenesis Markers and Disease-free Survival||Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry||||||
156022|NCT00326898|Secondary|5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|Patients with clear cell histology were included in this analysis.||proportion of participants||97.5% Confidence Interval|Number
156023|NCT00326898|Secondary|Proportion of Patients With Cardiac Events|Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|Patients with at least 1 follow-up MUGA scan were included in this analysis.||Proportion of participants||90% Confidence Interval|Number
156024|NCT00326898|Secondary|5-year Overall Survival Rate|Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry|All randomized patients||proportion of participants||97.5% Confidence Interval|Number
156025|NCT00326898|Primary|Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients||years||97.5% Confidence Interval|Median
156026|NCT00326885|Primary|Increase of Paracentesis/Puncture-free Interval (Ratio)|The parameter to be tested is the ratio of the post-treatment puncture/paracentesis-free interval divided by the pre-treatment puncture/paracentesis-free interval. The pre-treatment interval is defined as the length of time between the patient`s most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|180 days|||fold||Full Range|Median
156027|NCT00326885|Secondary|Ascites Volume|Ascites volume measurement were to be performed at screening (= prior to baseline), at baseline (= before start of therapy with catumaxomab) and during the 6-month follow-up period when the patient had recurrence of symptomatic ascites requiring therapeutic paracentesis. At each paracentesis, drainage to dryness was to be achieved and the exact volume was to be measured and documented.|6 months|||mL||Full Range|Median
156028|NCT00326885|Secondary|Ascites Signs and Symptoms|"Patient-reported ascites symptoms were to be assessed using the patient questionnaire, Functional Assessment of Chronic Illness Therapy – Ascites Index (FACIT-AI). At 6 months following catumaxomab administration, the patient was requested to assess the severity of the following parameters during the past week using a 5-point scale with scores from 0 = not at all to 4 = very much: anorexia, insomnia, decreased mobility, dyspnea, nausea, vomiting, abdominal pain, abdominal distention, fatigue, early satiety, urinary frequency, constipation, and emotional distress. For the parameters anorexia, insomnia, and decreased mobility, high scores mean good response, for the other parameters low scores mean good response."|6 months|||units on a scale||Full Range|Median
156029|NCT00326885|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from the date of first dose to the date of death.|≥ 6 months|||months||95% Confidence Interval|Median
156030|NCT00326885|Secondary|Puncture/Paracentesis-free Survival (PuFS)|Puncture/Paracentesis-free Survival (PuFS), Defined as the Number of Days Between the Date of Last Dose and the Date of Documented End of Study (EoS) Paracentesis or Death, Whichever Occurred First|≥6 months|Full analysis set (FAS) Per protocol (PP)||weeks||Full Range|Median
156031|NCT00326885|Primary|The Proportion of Patients Who Achieved at Least a 4-fold Increase of Puncture/Paracentesis-free Interval Following Catumaxomab Relative to Their Pre-treatment Interval.|The parameter to be estimated is the proportion of patients who achieve at least a 4-fold increase in their puncture/paracentesis-free interval. The pretreatment interval is defined as the length of time between the patient’s most recent paracentesis (baseline) and the subsequent paracentesis necessitated by her increasing ascites-related symptoms. The post-treatment interval is defined as the time between the last dose of catumaxomab plus 1 day to the time of recurrence of ascites requiring therapeutic paracentesis or death, whichever occurred sooner.|6 months|||proportion of patients|||Number
156032|NCT00326872|Secondary|Reduction in Self Reported Worst Pain Per Cycle.|Reduction in self reported worst pain per cycle as measured by the Worst Pain scale from the North Central Cancer Treatment Group Brief Pain Inventory (short form). The worst pain scale is from 0-10 (10 is worst pain possible). The per-cycle average reduction in worst pain will be analyzed using generalized linear models to account for repeated measures within patients.|At baseline, prior to each subsequent course (q 28+/- 3 days), and at end of treatment up to 51 months|||units on a scale of 0-10||Standard Error|Mean
156033|NCT00326872|Secondary|Time to Treatment Failure as Assessed Using the Method of Kaplan-Meier|"Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment.~Time to treatment failure will be estimated using the method of Kaplan-Meier."|From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal up to 51 months.|||Months||95% Confidence Interval|Median
156034|NCT00326872|Secondary|Duration of Response as Assessed Using the Method of Kaplan-Meier|Duration of response is defined for all evaluable patients who have achieved a confirmed tumor objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be estimated using the method of Kaplan-Meier.|From time of confirmed tumor objective response as CR or PR to the date of progression max 51 months|There was only 1 response and due to patient confidentiality we are not reporting this endpoint.|||||
156035|NCT00326872|Secondary|Time to Disease Progression as Measured Using Kaplan-Meier Method|"Progression (PD): At least a 20% increase in the sum of volumes of target lesions taking as reference the smallest volume recorded since the treatment started or the appearance of one or more new lesions.~If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death."|From registration to documentation of disease progression up to 26 cycles (28 days/cycle).|||Months||95% Confidence Interval|Median
156036|NCT00326872|Secondary|Survival Time as Measured Using Kaplan-Meier Method|Survival time is defined as the time from registration to death due to any cause.|From registration to death (due to any cause) max 51 months|||Months||95% Confidence Interval|Median
156037|NCT00326872|Primary|Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])|"Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the volume of target lesions taking as reference the baseline volume."|Baseline to end of treatment, maximum of 26 cycles (28 days/cycle).|||Proportion of patients||95% Confidence Interval|Number
156038|NCT00326781|Secondary|Verified 7-day Point Prevalence Abstinence at End Of Treatment.|"End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey.~This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey."|End of Treatment|||participants|||Number
156039|NCT00326781|Primary|Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)|A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).|End of Treatment (8-weeks after quit date)|Analysis was intention to treat (ITT)||Participants|||Number
156040|NCT00326716|Primary|Mean RTV Time of Maximum Observed Plasma Concentration (Tmax)|Tmax = time to reach the maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, Weeks 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||Hours||95% Confidence Interval|Geometric Mean
158539|NCT00303862|Secondary|Performance of DCE_MRI|Binary (yes/no) indicator of whether a dynamic contrast-enhanced MRI (DCE-MRI)was successfully performed.|One month after initiating therapy|Because trial was closed due to poor accrual, MRI data were not collected.|||||
156043|NCT00326716|Secondary|Multicenter AIDS Cohort Study (MACS) Participant Adherence to Regimen and Drug Components for ATV 300 mg / RTV 100 mg Test Dose|The MACS was administered to evaluate participant adherence to each drug and the adherence to the regimen. The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Study Week 2, Pregnancy Weeks 20 to Weeks 28, Pregnancy Weeks 28 to Delivery, Week 2 Postpartum, Week 4 Postpartum|All treated participants were included in this evaluation.||Participants|||Number
156044|NCT00326716|Secondary|Mean Atazanavir Plasma Protein Binding|Atazanavir Plasma Protein Binding Percentage measured at specified time points.|Pregnancy Weeks 28 to Delivery at 3 Hours Postdose and 24 Hours Postdose, and Time of Delivery|||Percentage Bound||Standard Deviation|Mean
156045|NCT00326716|Secondary|Median Infant Total Bilirubin Level|Median infant total bilirubin level as measured at specified time points.|Birth (Day 1), Day 3, Day 5, and Day 7 of Life|||mg / dL||Inter-Quartile Range|Median
156046|NCT00326716|Secondary|Mean Atazanavir Maternal Plasma Concentration and Neonatal Cord Blood Concentration|Mean atazanavir maternal plasma concentration and neonatal cord blood concentration as measured at the time of delivery.|At Time of Delivery|||ng / mL||Standard Deviation|Mean
156047|NCT00326716|Primary|Mean ATV Terminal Elimination Half Life (T 1/2)|T 1/2 = terminal elimination half life of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||Hours||95% Confidence Interval|Geometric Mean
156048|NCT00326716|Primary|Mean RTV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
156049|NCT00326716|Primary|Mean ATV Trough Plasma Concentration (Cmin) 24 Hours Following the Daily Dose|Cmin = plasma concentration 24 hours post dose of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
156050|NCT00326716|Primary|Mean RTV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of ritonavir in one dosing interval.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
156051|NCT00326716|Primary|Mean ATV Area Under the Concentration Curve (AUC TAU)|AUC = area under the concentration curve (AUC [TAU]) of atazanavir in one dosing interval from time zero to 24 hours.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||ng•h / mL||95% Confidence Interval|Geometric Mean
156052|NCT00326716|Primary|Mean RTV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of ritonavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the PK concentration data set.||ng / mL||95% Confidence Interval|Geometric Mean
156053|NCT00326716|Primary|Mean ATV Maximum Plasma Concentration (Cmax) in One Dosing Interval|Cmax = maximum observed plasma concentration of atazanavir at specified time points.|Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum|Treated participants in the pharmacokinetic (PK) concentration data set.||ng / mL||95% Confidence Interval|Geometric Mean
156054|NCT00326716|Primary|Infant Race||At the time of delivery|All infants.||Participants|||Number
156055|NCT00326716|Primary|Infant Gender||At the time of delivery|All infants.||Participants|||Number
156056|NCT00326716|Primary|Infant Gestational Age at Delivery||At the time of delivery|All infants.||Weeks||Standard Error|Mean
156057|NCT00326716|Secondary|SAEs in Enrolled Infants|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|Birth Through Week 16 of Life|SAEs were recorded for all enrolled infants.||Participants|||Number
156058|NCT00326716|Secondary|SAEs in Enrolled Mothers|SAEs were evaluated for all treated and untreated participants. An SAE was defined as an untoward medical occurrence that results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event); might have caused death if it were more severe, required inpatient hospitalization or prolongation of existing hospitalization, in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, an important medical event that required intervention to prevent serious outcomes.|During Study Period and 30 Days Post-Study.|Data were analyzed for all treated and untreated mothers.||Participants|||Number
156059|NCT00326716|Secondary|Number of Participants With Grade 2 to Grade 4 AEs and SAEs|AEs and SAEs considered possibly, probably, or certainly related to study treatment, were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). Hyperbilirubinemia (Grade 1=1.1 to 1.5 upper limit of normal [ULN] [mild], Grade 2=1.6 to 2.5 ULN [moderate], Grade 3=2.6 to 5.0 ULN [severe], Grade 4= > 5.0 ULN [potentially life threatening]).|During Study Period and 30 Days Post-Study.|Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants. The number of AEs and SAEs is based on enrolled participants.||Participants|||Number
156079|NCT00326599|Secondary|Progression-free Survival Rate at 6 Months After Randomization (Phase II Patients Only)|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.|6 months|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.||percentage of participants||95% Confidence Interval|Number
156060|NCT00326716|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE =any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|During study period and 30 days post-study.|The number of SAEs is based on enrolled participants. Data were pooled from the ATV 300 mg / RTV 100 mg and ATV 400 mg / RTV 100 mg groups for all treated mothers and all infants.||Participants|||Number
156061|NCT00326716|Secondary|Infant HIV Status|The neonatal HIV-1 status are assessed by the Roche Amplicor HIV-1 DNA Assay Version 1.5 (Roche Molecular Systems).|Birth Through 6 Months on Study|All infants.||Participants|||Number
156062|NCT00326716|Secondary|Mean CD4 Cell Count at Baseline||Baseline|All treated participants.||cells / mm^3||Standard Error|Mean
156063|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal Cluster of Differentiation 4 (CD4) Cell Count|The median CD4 cell count change from baseline was calculated for all treated mothers at the time of delivery ± 2 days. Maternal CD4 cell counts were assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median CD4 Cell Count Change From Baseline was calculated based on all treated mothers. The maternal CD4 cell count at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.||cells / mm^3||Inter-Quartile Range|Median
156064|NCT00326716|Secondary|Mean HIV RNA Level at Baseline||Baseline|All treated participants.||log10 cm / mL||Standard Error|Mean
156065|NCT00326716|Secondary|Median Change From Baseline to Day of Delivery in Maternal HIV RNA Level|The maternal HIV RNA level was determined at baseline and the day of delivery ± 2 days using VR-OC. The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Baseline, Day of Delivery ± 2 Days|The median maternal HIV RNA Level Change From Baseline was calculated for all treated mothers at the time of delivery. The maternal HIV RNA level at delivery was determined as the closest to delivery and within a pre-defined visit window for delivery, which is delivery date ± 2 days.||log10 c / mL||Inter-Quartile Range|Median
156066|NCT00326716|Secondary|Maternal HIV Ribonucleic Acid (RNA) Level on Day of Delivery|The maternal HIV RNA level is assessed by the Roche Amplicor® Ultrasensitive Assay Version 1.5.|Day of Delivery ± 2 Days|The analysis for the proportion of HIV RNA < 400 and < 50 c/mL at delivery is based on the Virologic Response - Observed Cases (VR-OC). VR-OC classifies subjects who remain on study therapy as responders according to a single HIV RNA measurement < 400 c/mL (or < 50 c/mL) closest to delivery and within delivery date ± 2 days.||Participants|||Number
156067|NCT00326612|Secondary|Respiratory Depression Requiring Oxygen at Discharge From the Emergency Department.|Respiratory depression was defined as requiring oxygen at discharge from the Emergency Department.|24 hours|Analysis was per protocol||participants|||Number
156068|NCT00326612|Secondary|Number of Patients Who Had a Repeat Seizure Within 12 Hours After Their Seizure Who Used Study Medication||12 hours|||participants|||Number
156069|NCT00326612|Secondary|Number of Patients That Were Admitted to the Hospital After Their Seizure and Use of Study Medication.||24 hours|||participants|||Number
156070|NCT00326612|Secondary|Number of Patients Needed to be Seen or Treated in the Emergency Department for Their Seizure and Use of Study Medication.||24 hours|||participants|||Number
156071|NCT00326612|Secondary|Number of Patients Who Needed Additional Medication to Treat the Seizure in the Emergency Department Within 24 Hours||24 hours|||participants|||Number
156072|NCT00326612|Secondary|Respiratory Depression Requiring Intubation|Respiratory depression was defined as intubation at Emergency Department discharge.|24 hours|Analysis was per protocol||participants|||Number
156073|NCT00326612|Primary|Length of Seizure After Study Medication Administration|Length of seizure.|24 hours|Analysis was per protocol||Minutes||Inter-Quartile Range|Median
156074|NCT00326599|Secondary|Dose Limiting Toxicity (DLT) (Lead-in Phase Arm I Patients Only)|DLT was defined as an adverse event occurring in cycle 1 only, at least possibly attributed to the study treatment and meeting the following criteria: 1) Grade 4 absolute neutrophil count (ANC) >5 days or of any duration with fever >38.5 degree Celsius; 2) Grade 4 platelet count; 3) Grade 3 or higher non-hematologic toxicities (for nausea, vomiting or diarrhea, grade 3 toxicities will be DLT if they occur despite maximal use of anti-emetic support or anti-diarrhea agents, respectively); 4) Cediranib dose interruption of >14 days for drug-related toxicities.|Cycle 1|The first 6 participants treated on Arm I (lead-in phase).||participants|||Number
156075|NCT00326599|Secondary|Overall Survival (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All phase II participants who met eligibility criteria and started the treatment.||months||95% Confidence Interval|Median
156076|NCT00326599|Secondary|Overall Survival at 1 Year After Randomization (Phase II Patients Only)|Overall survival was defined as the time from study enrollment to the time of death from any cause. A patient is classified as a success if alive at 1 year.|1 year|All phase II participants who met eligibility criteria and started the treatment.||percentage of participants||95% Confidence Interval|Number
156077|NCT00326599|Secondary|Time to Treatment Failure (Phase II Patients Only)|Time to treatment failure was defined to be the time from date of registration to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 15 months|All phase II participants who met the eligibility criteria and have ended the study treatment.||months||95% Confidence Interval|Median
156078|NCT00326599|Secondary|Progression-free Survival (Phase II Patients Only)|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.||months||95% Confidence Interval|Median
156080|NCT00326599|Primary|Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II Patients Only)|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart.|Up to 5 years|All phase II participants who met eligibility criteria and have received at least one cycle of treatment.||percentage of participants||95% Confidence Interval|Number
156081|NCT00326495|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|96 months, 26 days|Although 51 patients were accrued, only 50 were on study long enough for assessment.||participants|||Number
156082|NCT00326495|Primary|Overall Rate of Response|Rate of response is defined as the percentage of participants with a complete response (CR) + partial response (PR) + stable disease (SD) for 4 months. Response is defined by the Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete response is a disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum LD since the treatment started. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|4 months|Although 51 patients were accrued, only 50 were on study long enough for assessment.||percentage of participants|||Number
156083|NCT00326417|Secondary|Overall Survival (OS)|OS is defined as alive at 1 year, the event is death from any cause. Patients alive at the time of last observation, for statistical purposes, will have a survival time which is censored.|Day 365|||percentage of participants||95% Confidence Interval|Number
156084|NCT00326417|Secondary|Chronic GVHD|Chronic GVHD is scored according to the BMT CTN MOP. The first day of chronic GVHD onset will be used to calculate cumulative incidence curves.|Day 365|||percentage of participants||95% Confidence Interval|Number
156085|NCT00326417|Secondary|Acute Graft vs Host Disease (GVHD)|All GVHD grades 2-4 will be graded according to the BMT CTN Manual of Procedures (MOP)|Day 100|||percentage of participants||95% Confidence Interval|Number
156086|NCT00326417|Secondary|Cumulative Incidence of Graft Failure|Primary and secondary graft failure are included, secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in the ANC to less than 0.5 x 10^9/L for three consecutive measurements on different days, unresponsive to growth factor.|Day 365|||percentage of participants|||Number
156087|NCT00326417|Primary|Disease-free Survival (DFS)|DFS includes graft failure, regimen-related toxicity (RRT), and early death. Graft Failure is defined by lack of neutrophil engraftment (ANC less than 0.5 x 10^9/L for 3 consecutive days on different days). Major RRT is defined as severity of grade 4 in any organ system or grade 3 for pulmonary, cardiac, renal, oral mucosal or hepatic. Early death is defined as death prior to Day 100 post-transplant.|Day 100|||participants|||Number
156088|NCT00326196|Primary|The Hypothesis Being Tested is That a Strategy of Initial Surgical Revascularization is Superior to Percutaneous Intervention in Preventing Death or Myocardial Infarction in Diabetics With Severe Ischemic Heart Disease Assessed up to 4 Years.|Participants were monitored for up to 4 years. This is the number of particiapnts who have died or had at least one myocardial infarction.|Date of Death and non-fatal MI|The number of participants for analysis was determined by intent to treat principal.||participants|||Number
156089|NCT00326183|Primary|Participants With Elevated Temperature (>=102.2F/39.0C)||Days 1 to 5 After Any Vaccination|Includes all subjects who provided body temperature follow-up data after any dose of vaccine.||participants|||Number
156090|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
156091|NCT00326183|Primary|Participants With Varicella/Zoster-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
156092|NCT00326183|Primary|Participants With Rubella-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
156093|NCT00326183|Primary|Participants With Rubella-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
156094|NCT00326183|Primary|Participants With Mumps-Like Symptoms After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.||participants|||Number
156095|NCT00326183|Primary|Participants With Mumps-Like Symptoms After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for mumps-like symptoms.||participants|||Number
156096|NCT00326183|Primary|Participants With Measles-Like Rash After Second Vaccination||Days 1 to 28 After Second Vaccination|Includes all subjects who provided safety follow-up data after the second vaccinations were administered. Only the VAQTA™ + ProQuad™ group was followed for rashes.||participants|||Number
156097|NCT00326183|Primary|Participants With Measles-Like Rash After First Vaccination||Days 1 to 28 After First Vaccination|Includes all subjects who provided safety follow-up data after the first vaccinations were administered. Only the VAQTA™ +ProQuad™ group was followed for rashes.||participants|||Number
156098|NCT00326183|Primary|Participants With 1 or More Injection-Site Adverse Experiences||Days 1 to 14 after any vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.||participants|||Number
156099|NCT00326183|Secondary|Participants With 1 or More Systemic Adverse Experiences||Days 1 to 14 After Any Vaccination|Includes all subjects who provided safety follow-up data after any dose of vaccine out of the total number of subjects enrolled.||participants|||Number
156101|NCT00326170|Primary|Number of Participants With Response|Clinical activity of combination defined as: Complete Response (CR), bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/L or more and platelet count of 100x10^9 or more; Complete response without platelets (CRp), a complete response except for a platelet count less than 100x10^9 and transfusion independent; and Bone Marrow (BM) Response, bone marrow blast of 5% or less but without meeting the peripheral blood count criteria for (CR) or (CRp).|Up to 12 cycles of treatment (28 day cycles)|||Participants|||Number
156102|NCT00326118|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|"A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.~For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually."|Throughout the entire study period (up to year 5)|Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study.||Subjects|||Number
156103|NCT00326118|Secondary|Number of Subjects Reporting Unsolicited Symptoms|Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|Within 31 days (Day 0 - Day 30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.||Subjects|||Number
156104|NCT00326118|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the injection site.~Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite."|Within 4 days (Day 0 -Day 3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.||Subjects|||Number
156105|NCT00326118|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
156106|NCT00326118|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values|Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.|Prior to, 1 month, 1 year, 2 years and 3 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
156107|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
156108|NCT00326118|Secondary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs).|Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
156109|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
156110|NCT00326118|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values|Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
156111|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||Titer||95% Confidence Interval|Geometric Mean
156126|NCT00325897|Secondary|Exacerbations/Patient Year|"Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly until 13 months|Participants with any follow-up data were analyzed.||exacerbations/patient year|||Number
156112|NCT00326118|Secondary|Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers|Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Titer||95% Confidence Interval|Geometric Mean
156113|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.|5 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
156114|NCT00326118|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values|"rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers.~Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition."|Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.||Subjects|||Number
156115|NCT00326118|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer|rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.||Subjects|||Number
156116|NCT00326118|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)|Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.|1 month after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.||Subjects|||Number
156117|NCT00326001|Secondary|Number of Patients With Charred Catheter Tips|Char or coagulum formation on the catheter tip|ablation procedure|per protocol||Patients|||Number
156118|NCT00326001|Secondary|Number of Patients With Long-term Treatment Success|No recurrence of atrial flutter after ablation|6 months after ablation|per protocol||Patients|||Number
156119|NCT00326001|Secondary|Ablation Success With the First Catheter|"Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N).~Positive final bidirectional cavotricuspid isthmus condution block test means ablation successful.~Negative final bidirectional cavotricuspid isthmus condution block test means ablation unsuccessful; ablation should be continued until success or terminated and classified as unsuccess."|ablation procedure|per protocol||Patients|||Number
156120|NCT00326001|Primary|Duration of Energy Application|Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.|ablation procedure|Per protocol||minute||Standard Deviation|Mean
156121|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from some participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|During Course of Study (either month 3, 6, 9, or 12)|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.||participants|||Number
156122|NCT00325897|Secondary|Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum|Cultures from 68% of the participants in the azithromycin group and 70% in the placebo group who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.|Baseline|Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.||Participants|||Number
156123|NCT00325897|Secondary|Change in Age-adjusted Hearing Threshold|Assessed by audiometry for four sound frequencies (1000, 2000, 3000, 4000 Hz). The maximum was computed for each threshold in each ear for all frequencies, then the differences between visits were assessed.|Baseline and 12 months|Participants with both baseline and one-year audiometry data available were analyzed.||Decibels (db)||Standard Deviation|Mean
156127|NCT00325897|Primary|Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Time until first occurrence of acute Chronic Obstructive Pulmonary Disease (COPD) exacerbation. Acute exacerbations are defined as a complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "|Measured monthly through 13 months|Participants that had any follow-up data were included in analysis.||Days||95% Confidence Interval|Median
156128|NCT00325819|Secondary|Parent Time Lost From Work|Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days.|Through the day after vaccination|Refers to the number of participants for whom parents reported that they were scheduled to work on the day of the vaccination visit or the day following the child's vaccination visit.||percentage of participants|||Number
156129|NCT00325819|Secondary|Infant Time Lost From Sleep|Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations|||percentage of participants|||Number
156130|NCT00325819|Secondary|Parent Time Lost From Sleep|Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night.|On the night following vaccinations|||percentage of participants|||Number
156131|NCT00325819|Secondary|Infant Fussiness|Parents were asked to record level of fussiness (compared with the child’s usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual.|Within 32 hours of vaccination|||percentage of participants|||Number
156132|NCT00325819|Secondary|Medical Utilization|Telephone calls to the consulting nurse or the child’s physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination.|Within 32 hours of vaccination.|||percentage of participants|||Number
156133|NCT00325819|Secondary|Study Assignment Unblinded|The need for unblinding at any time during the study|At any time during participation in the study|||percentage of participants|||Number
156134|NCT00325819|Secondary|Fever >=39C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=39C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.||percentage of participants|||Number
156135|NCT00325819|Primary|Fever >=38C Within 32 Hours of Vaccination.|Fever, defined as rectal temperature >=38C within 32 hours of vaccination.|Fever within 32 hours following vaccination|Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group.||percentage of participants|||Number
156136|NCT00325780|Secondary|Change From Baseline in Total Cholesterol|Mean percent change from baseline in total cholesterol|Baseline to 52 weeks|Patients who had an observation at Week 52||percent change||Standard Deviation|Mean
156137|NCT00325780|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)|Baseline to 52 Weeks|Patients who had an observation at Week 52||percent change||Standard Deviation|Mean
156138|NCT00325754|Secondary|Mid-day Activity Monitoring at 6 Months|Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM.|6 months|||Vector magnitude units (VMU)/min||Standard Deviation|Mean
156139|NCT00325754|Secondary|Average Mid-day Activity Monitoring at 3 Months|Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.|3 Months|||Vector magnitude units (VMU)/min||Standard Deviation|Mean
156140|NCT00325754|Primary|Stationary Oxygen Use Daily||Baseline|||Hours||Standard Deviation|Mean
156141|NCT00325754|Primary|Ambulatory/Portable Oxygen Use Daily||6 months|||Hours||Standard Deviation|Mean
156142|NCT00325754|Primary|Stationary Oxygen Use Daily||6 Months|||Hours||Standard Deviation|Mean
156143|NCT00325598|Secondary|Distant Control Rate||Up to 5 years||04/2018||||
156144|NCT00325598|Secondary|Regional Control Rate||Up to 5 years||04/2018||||
156145|NCT00325598|Secondary|Local Control Rate||Up to 5 years||04/2018||||
156146|NCT00325598|Secondary|Cosmetic Outcome||Up to 5 years||04/2018||||
156147|NCT00325598|Secondary|Incidence of Fat Necrosis||Up to 5 years||04/2018||||
156148|NCT00325598|Secondary|Incidence of Breast Fibrosis||Up to 5 years||04/2018||||
156149|NCT00325598|Secondary|Incidence and Severity of Cutaneous Toxicity||Up to 5 years||04/2018||||
156150|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity|-The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity|Within 1 year of protocol registration|||percentage of participants|||Number
156151|NCT00325598|Primary|Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan|-The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.|Within 1 year of protocol registration|||percentage of participants|||Number
156152|NCT00325468|Secondary|Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8||8 years|Subjects with nonmissing value at parent study 20010223 baseline and Year 8||percent||Inter-Quartile Range|Median
156157|NCT00325442|Secondary|Change in Symptoms of PAH From Baseline to Week 16|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.|Baseline and 16 weeks|||units on a scale||Standard Error|Mean
156158|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA and PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA and PDE5-I for 90 days or greater at the time of randomization.||meters||Inter-Quartile Range|Median
156159|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: PDE5-I||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with a PDE5-I for 90 days or greater at the time of randomization.||meters||Inter-Quartile Range|Median
156160|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Background PAH Therapy: ERA||Baseline and 16 weeks|The subjects in this subgroup were receiving treatment with an ERA for 90 days or greater at the time of randomization.||meters||Inter-Quartile Range|Median
156161|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomization: Study Drug Dose 0.25 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.25 mg for initiation of study drug dosing and dose titration.||meters||Inter-Quartile Range|Median
156162|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Study Drug Dose Strength Available at Randomizaiton: Dose Strength 0.5 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 0.5 mg for initiation of study drug dosing and dose titration.||meters||Inter-Quartile Range|Median
156163|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Lowest Dose Strength Available at Randomization: Smallest Dose Available 1 mg||Baseline and 16 weeks|The subjects in this subgroup had a minimum tablet strength of 1 mg for initiation of study drug dosing and dose titration.||meters||Inter-Quartile Range|Median
156164|NCT00325442|Post-Hoc|Change in Six Minute Walk Distance (6MWD) From Baseline in Subjects Who Received Oral Treprostinil by Last Study Drug Dose and Reason for Discontinuation|In general, the dose of study drug was increased in 0.5 mg increments every 3 days, in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.|Baseline and 16 weeks|Of 174 subjects randomized to receive oral treprostinil, 153 subjects who completed the study and 6 additional subjects who did not complete the study but discontinued the study due to adverse events were included in this analysis.||meters||Inter-Quartile Range|Median
156165|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 4 (398 - 450 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 4 (398 - 450 meters).||meters||Inter-Quartile Range|Median
156166|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 3 (363 - 397 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 3 (363 - 397 meters).||meters||Inter-Quartile Range|Median
156167|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartile: Quartile 2 (303 - 362 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 2 (303 - 362 meters).||meters||Inter-Quartile Range|Median
156168|NCT00325442|Post-Hoc|Six Minute Walk Distance (6MWD) by Baseline 6MWD Quartiles: Quartile 1 (126-302 Meters)||Baseline and 16 weeks|The study population was divided into quartiles by Baseline 6MWD. The subjects in this subgroup were in quartile 1 (126 - 302 meters).||meters||Inter-Quartile Range|Median
156169|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 4 weeks|||meters||Inter-Quartile Range|Median
156170|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 8 weeks|||meters||Inter-Quartile Range|Median
156171|NCT00325442|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 12 weeks|||meters||Full Range|Median
156172|NCT00325442|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Week 16|||participants|||Number
156173|NCT00325442|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and 16 Weeks|Five subjects in the placebo arm and three subjects in the active arm did not have a Baseline dypsnea-fatigue index score.||units on a scale||Standard Deviation|Mean
156174|NCT00325442|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening required one of the following:~Death (all causes excluding accident)~Transplantation or atrial septostomy~Clinical deterioration as defined by:~Hospitalization as a result of PAH, or~≥ 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And~Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin)."|Baseline and 16 Weeks|||participants|||Number
156175|NCT00325442|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and 16 Weeks|One subject in the placebo arm did not have a Baseline Borg score value.||units on a scale||Standard Deviation|Mean
156176|NCT00325442|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug."|Baseline and 16 Weeks|||meters||Inter-Quartile Range|Median
156177|NCT00325416|Other Pre-specified|Breast Cancer Resistance Protein (BCRP) Expression|BCRP function will be assayed in multiple myeloma patient bone marrow aspirates obtained before and during high dose chemotherapy. BCRP function is expressed as the change in relative fluorescence in topotecan versus control cells. The distribution of paired differences in BCRP, a continuous variable, will be summarized using descriptive statistics and will be correlated with response and toxicity.|Laboratory study (N/A)||||||
156178|NCT00325416|Other Pre-specified|Genomic DNA Sequence Variations and Correlate With Toxicity to Melphalan and Topotecan|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)||||||
156179|NCT00325416|Other Pre-specified|DNA Topoisomerase I Amount, Activity, or Subcellular Distribution|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (N/A)||||||
156180|NCT00325416|Other Pre-specified|Amount, Activity and Subcellular Distribution of Topoisomerase I With Clinical Response and Toxicity|Laboratory Correlates will be summarized using descriptive statistics.|Laboratory study (no specific time points)||||||
156181|NCT00325416|Other Pre-specified|Pharmacokinetic Profiles of High Dose Topotecan and Melphalan|Evaluate the pharmacokinetic profiles of high dose topotecan and melphalan and to investigate the pharmacodynamic relationships with respect to the efficacy and toxicity of this regimen in each age group. Pharmacokinetics of Topotecan: For all dose levels, topotecan levels on Day -4 will be obtained at -15 min, 20 min into 30 min infusion, and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, and 23 h after the 30 min infusion. Pharmacokinetics of Melphalan: For all dose levels, melphalan levels during the first day of cytoxan priming chemotherapy and on Day -4 will be obtained before, at the end of the infusion, and 5 minutes (min), 15 min, 30 min, 45 min, 60 min, 90 min, 120 min and 180 min after the infusion. The infusion time for the test dose of melphalan is over 5 min and for the high-dose is over 30 min.|Predetermined time points in protocol||||||
156182|NCT00325416|Secondary|Phase II Overall Survival (OS)|Time from start of treatment until death from any cause.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis||months||95% Confidence Interval|Median
156183|NCT00325416|Secondary|Phase II Event Free Survival (EFS)|Time to treatment failure, which is defined as the time from day 0 to the time of progressive disease. Progressive disease is defined by unequivocal objective evidence and constitutes any of the following: 1). an increase in the total amount of monoclonal protein (M-component from Serum Protein Electrophoresis (SPEP) and/or Urine Protein Electrophoresis (UPEP) with immunofixation) by more than 100% from the lowest level of serum myeloma protein seen after high-dose chemotherapy by serum protein electrophoresis; 2). an increase in the total amount of monoclonal protein above the remission level of the myeloma peak (i.e., an increase of >25% above the lowest level in a 24 hour urine or serum protein; 3). the reappearance of the M-protein if the patient had entered a CR: 4). definite increase in the size (> 1 cm) or number of lytic bone lesions. Compression fractures do not constitute a relapse.|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) evaluable participants at time of analysis||months||95% Confidence Interval|Median
156184|NCT00325416|Primary|Phase II Participants - Overall Response Rate|Re-evaluation of participants who had responsive disease prior to transplant. All changes in monoclonal protein and immunoglobulins will be referenced to those levels obtained immediately prior to cyclophosphamide priming chemotherapy. Complete Response (CR): A CR will be defined as the disappearance of the monoclonal protein by immunofixation studies of serum and urine (100x concentrate) and less than or equal to 5% plasma cells in a bone marrow aspirate. Partial Response (PR): 50% - 74% decrease in the measurable monoclonal protein (M-component from an SPEP and/or UPEP with immunofixation).|Phase II - Phase start at 62 months up to 120 months|Phase II (treatment at MTD) participants with responsive disease prior to transplant.||percentage of participants|||Number
156185|NCT00325416|Primary|Phase I - Maximum Tolerated Dose (MTD) Level|"MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety.~Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2"|Phase I - 5 years, 2 months|Phase I Dose Escalation participants.||mg/m^2|||Number
156194|NCT00325403|Secondary|Dyspnea-Fatigue Index|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 12|Two subjects (one in the placebo arm and one in the oral treprostinil arm) from the primary analysis population (n=228) did not have a Baseline dyspnea-fatigue index score and were not included in this analysis.||units on a scale||Standard Deviation|Mean
156186|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
156187|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
156188|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration. This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at the time of randomization.~The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
156189|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) for the Entire Study Population|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data collected from all subjects enrolled in the study, regardless of tablet strength availability at randomization.~The six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Wk 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference i"|Baseline and Week 12|This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.||meters||Inter-Quartile Range|Median
156190|NCT00325403|Post-Hoc|Six Minute Walk Distance (6MWD) by PAH Etiology: Idiopathic or Heritable PAH|"Exploratory efficacy analyses were to determine the effect of PAH etiology (idiopathic/heritable, associated with collagen vascular disease, and other etiologies) on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|||meters||Inter-Quartile Range|Median
156191|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification: I or II|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|||meters||Inter-Quartile Range|Median
156192|NCT00325403|Post-Hoc|Six Minute Walk Distance by Baseline WHO Functional Classification III or IV|"Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|||meters||Inter-Quartile Range|Median
156193|NCT00325403|Secondary|Symptoms of PAH|Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.|Baseline and Week 12|||units on a scale||Standard Deviation|Mean
156195|NCT00325403|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).|Baseline and Week 12|||units on a scale||Inter-Quartile Range|Median
156196|NCT00325403|Secondary|World Health Organization Functional Classification for PAH|"Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity."|Baseline and Week 12|Subjects with a WHO functional classification assessment at Week 12.||participants|||Number
156197|NCT00325403|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:~Death (all causes excluding accident)~Transplantation or atrial septostomy~Clinical deterioration as defined by:~Hospitalization as a result of PAH, or~greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And~Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)"|Baseline and Week 12|||participants|||Number
156198|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 4|Analyses were conducted using the modified intention to treat (mITT), which includes subjects who had access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
156199|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 8|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
156200|NCT00325403|Secondary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.~The six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 11|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
156201|NCT00325403|Primary|Six Minute Walk Distance (6MWD)|"Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.~The Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians."|Baseline and Week 12|Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).||meters||Inter-Quartile Range|Median
156202|NCT00325234|Secondary|Number of Participants With Adverse Events (AE)|A listing of adverse events is presented in the Reported Adverse Event Module.|every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)|All randomized participants who received at least one dose of study drug.||participants|||Number
158540|NCT00303862|Primary|Objective Response|Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)|Up to 6 weeks|||percentage of participants||95% Confidence Interval|Number
156203|NCT00325234|Secondary|Time to Response|Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions.|Baseline to response (up to 7.8 months)|All randomized participants with CR or PR.||Months||95% Confidence Interval|Median
156204|NCT00325234|Secondary|Time To Treatment Failure (TTTF)|TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation.|Baseline to end of treatment (up to 21.9 months)|All randomized participants||Months||95% Confidence Interval|Median
156205|NCT00325234|Secondary|Time to Progressive Disease (PD)|Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy.|Baseline to measured PD (up to 25.1 months)|All randomized participants.||Months||95% Confidence Interval|Median
156206|NCT00325234|Secondary|Duration of Response (DOR)|DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date.|Time of response to progressive disease (up to 19 months)|All randomized participants with CR or PR.||Months||95% Confidence Interval|Median
156207|NCT00325234|Primary|Tumor Response Rate|Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100.|Baseline up to 30 days of follow-up after 21 cycles of treatment|All randomized patients who qualified for tumor response analysis by the following criteria: Females with histologic or cytologic diagnosis of advanced breast cancer previously treated with anthracyclines and taxanes. No concurrent antitumor therapy. Presence of measurable disease as defined by RECIST. Treatment with at least 1 dose of study drug.||percentage of participants||95% Confidence Interval|Number
156208|NCT00325195|Secondary|Change in Patient Reported Outcomes of Pain, Physical Function and Quality of Life|Health Assessment Questionnaire(HAQ: VAS pain scale where 0 (no pain)-100 (severe pain); HAQ disability index (HAQ-DI) on a scale from 0(no disability) to 3 (completely disabled), and a unit change of > or =0.22 is considerd a mimimal clinically important difference(MCID). SF-36 Physical Component Summary Score (SF36-PCS), a composite score where 0 is the worst score and 100 the best possible, and where a change of > or =2.5 units in the PCS is considered a MCID.|Baseline to Final Visit (Month 6 or LOCF)|Number of participants analyzed was based upon the number who had baseline and at least one follow-up assessment, with the final visit for each subject included (LOCF).||Units on a scale||Standard Deviation|Mean
156209|NCT00325195|Secondary|Change in Number of Tender Joints|Change from Baseline to Month 6 (or last observation carried forward) in number of tender joints per participant|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.||Tender joints||Standard Deviation|Mean
156210|NCT00325195|Secondary|Change in Number of Swollen Joints|Change from Baseline to Month 6 (or last observation carried forward)in number of swollen joints per subject. Values were inputed using last observation carried forward analysis for subjects who did not complete the studies.|Baseline and Final Visit (Month 6 or LOCF)|All ITT participants with baseline and at least one post-baseline assessment were included in analysis. LOCF was used for participants dropping out early.||Swollen joints||Standard Deviation|Mean
156211|NCT00325195|Secondary|Percentage of Subjects With Gout Flare Per 3-month Period|Percent of participants reporting a gout flare during Months 1-3 and Months 4-6. Denominator during the respective period was based upon number of participants during that period.|Months 1-3 and Months 4-6|Number analyzed in each period was based upon number of participants remaining in study during the assessed treatment period: 85/84/43 in Months 1-3 and 69/69/43 in Months 4-6||Percent subjects reporting flares|||Number
156212|NCT00325195|Secondary|Reduction in Tophus Burden|percentage of tophaceous subjects who demonstrated a complete resolution (100 % decrease in measured area or complete disappearance)of at least one tophus in the absence of other tophus progression or new tophi, as assessed by a blinded Central Reader using standardized digital photographs and image analysis software.|Baseline and Final Visit (6 months or LOCF)|Number of participants analyzed was based upon the number of patients who had one or more tophus at Baseline, as determined by the PI, AND who had at least one follow-up assessment, with the final visit for each subject included (last observation carried forward).||Percent subjects with resolved tophus|||Number
156213|NCT00325195|Primary|Plasma Uric Acid (PUA) Responder|PUA Responder was defined as a participant who achieved and maintained plasma uric acid concentrations < 6 mg/dL for at least 80% of the time during months 3 and 6 combined. Participants who withdrew from the study before month 6 were considered non-responders.|Months 3 and 6|Modified ITT (all patients receiving at least one dose of study drug). Participants dropping out before Week 25 were imputed as Non-Responders||Participants|||Number
156214|NCT00325156|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
156215|NCT00325156|Secondary|Number of Subjects Reporting Large Injection Site Swelling|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 18, post-booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.||Subjects|||Number
156216|NCT00325156|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
156217|NCT00325156|Primary|Number of Subjects Reporting Any Solicited Local and General Symptoms|Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C )], irritability and loss of appetite. Any was defined as any report of the specified symptom irrespective of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled-in the symptom sheet.||Subjects|||Number
156218|NCT00325143|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 21)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom data were available.||Subjects|||Number
156219|NCT00325143|Secondary|Number of Subjects Reporting Any Large Swelling Reactions|A large swelling reaction was defined as swelling with a diameter greater than (>) 50 millimeters (mm), noticeable diffuse swelling or noticeable increase of limb circumference.|At Month 15, post-booster dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
156220|NCT00325143|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
156221|NCT00325143|Primary|Number of Subjects Reporting Any Solicited Local and General Symptoms|Assessed solicited local and general symptoms were pain, redness, swelling, drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||Subjects|||Number
156222|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
156223|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
156224|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
156225|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations and must have post-vaccination data."||ELISA units/mL||95% Confidence Interval|Geometric Mean
156226|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have~post-vaccination data."||mMU/mL||95% Confidence Interval|Geometric Mean
156227|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|"Per-protocol population: subjects must~have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have~post-vaccination data."||mMU/mL||95% Confidence Interval|Geometric Mean
156228|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||mMU/mL||95% Confidence Interval|Geometric Mean
156229|NCT00325130|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||mMU/mL||95% Confidence Interval|Geometric Mean
156230|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
156231|NCT00325130|Primary|Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
156232|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
156233|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
156234|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
156235|NCT00325130|Primary|Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™||7 Months|Per-protocol population: subjects must have no major protocol violations and must have post-vaccination data.||Participants|||Number
156236|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
156237|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
156238|NCT00325130|Primary|Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
156239|NCT00325130|Secondary|Acceptable Safety Profile||15 days post injection||||||
156240|NCT00325130|Primary|Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)||7 Months|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
156241|NCT00325078|Other Pre-specified|Gut Immune Cell Types and Their Cytokine Profile|Gut Immune cell types and their cytokine profile|1 year||||||
156242|NCT00325078|Primary|Efficacy of Treatment With Study Drug|Measured participant Crohn’s disease Activity Index (CDAI) values. The CDAI is a tool comprised of clinical and laboratory factors such as stool frequency, consistency, abdominal pain, general well being, weight and blood profile as an objective measure of disease activity. A higher score corresponds to greater severity of inflammatory bowel disease; severe disease conventionally defined as >450, a remission as <150, and a response to treatment as a fall of CDAI of >70 points. Infections and IBD are not expected in healthy control subjects. The greater the score, the more severe the disease, and a score of less than 5 represents clinical remission.|Baseline, 1 year|All participants in the Treatment and Observation Arms with collected CDAI data. The CDAI, a tool validated for Crohn’s disease is not applicable to healthy donors or CGD patients without IBD, and therefore not measured in the Control participants.||Crohn's disease activity Index|||Number
156243|NCT00325078|Primary|Safety of Study Drug|Number of Infections from Baseline to 1 year|Baseline to 1 year|The volunteer group includes patients with chronic granulomatous disease as well as healthy normal volunteers as controls. Infection rates only pertain to and are counted in subjects with underlying immunodeficiency (chronic granulomatous disease).||infections|||Number
156244|NCT00325039|Secondary|Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months|Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)|12 months|This is the number of participants who had complete UDI information at the 12 month visit.||units on a scale||Standard Deviation|Mean
156245|NCT00325039|Secondary|Change in Quality of Life From Baseline to 12 Months|Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).|Baseline - 12 months|These are the number of patients with available quality of life data at the 12 month visit.||units on a scale||Standard Deviation|Mean
156246|NCT00325039|Primary|Subjective Treatment Success at 12 Months|Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 in the Retropubic arm and n=292 in the transobturator arm).||percentage of participants|||Number
156247|NCT00325039|Secondary|Patient Satisfaction at 12 Months|"Patient satisfaction was assessed at the 12 month visit with the questions, how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage? Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as satisfied and neutral, most dissatisfied and completely dissatisfied as not satisfied."|Follow-Up|This is the number of women who answered the satisfaction questions at the 12 month visit (n=280 attended the 12 month visit in the retropubic arm and n=285 in the transobturator arm)||percentage of participants analyzed|||Number
156263|NCT00324870|Primary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) (Phase II)|Estimated by Kaplan-Meier method|At 6 months|Progression free survival was summarized for the entire sample (n=37). The median survival times and 6-month survival rates are estim. based on the KP curve,w/ corresp. 95% confidence intervals using the log-log method. Conducted in SAS v9.3(Cary, NC). Progr.free survival time is calc. from date of first tx until date of progres./death or last fu.||percent||95% Confidence Interval|Number
156248|NCT00325039|Primary|Objective Treatment Success at 12 Months|"Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures~A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is <15g/24 hrs."|12 months|Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 and n=292 in RMUS, TMUS, respectively).||percentage of participants|||Number
156249|NCT00324961|Secondary|Time to Protocol-defined Complete Response Over a 104-week Treatment Period|Time to response was defined as the time to participants achieving protocol-defined complete response at week 104 from baseline. Protocol-defined complete response was an HBV DNA level ≤ 300 copies/mL by Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Baseline to Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||days||Standard Deviation|Mean
156250|NCT00324961|Secondary|Number of Participants Achieving Complete Response at Week 104|Complete response was defined as an HBV DNA level ≤ 300 copies/mL by the Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
156251|NCT00324961|Secondary|Number of Participants Achieving HBV DNA ≤300 Copies/mL Over Time|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. Missing data were not included in statistical analysis.||participants|||Number
156252|NCT00324961|Secondary|Number of Participants With ADV-associated Resistance at Week 104|Week 104 serum samples from participants who reached a HBV DNA breakthrough were assessed for the development of ADV (Adefovir dipivoxil) mutations (N236T and A181V) in the HBV polymerase. HBV DNA breakthrough was defined as an increase in HBV DNA level by 1 log10 copies/mL or more from the treatment nadir during Weeks 0 to 104.|Week 104|Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once.||participants|||Number
156253|NCT00324961|Secondary|Number of Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 104|HBsAg loss and HBsAg seroconversion (HBsAg loss and HBsAb detected) were assessed for all participants who were HBeAg negative at Weeks 0 and 104. Confirmed HBsAg loss was defined as undetectable HBeAg.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once||participants|||Number
156254|NCT00324961|Secondary|Number of Participants Achieving ALT Normalization at Week 104|Serum alanine aminotransferase (ALT) normalization was defined as a serum ALT level at or below the upper limit of the normal (ULN) range after a baseline value above the ULN, as determined using central laboratory ranges.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once. A total of 435 participants had a baseline ALT value above the ULN.||participants|||Number
156255|NCT00324961|Secondary|Change From Baseline in Median Serum HBV DNA Over Time|The HBV DNA level was tested in blood serum by real-time PCR with the LLD as 300 copies/mL at baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 in a central laboratory.|Baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104|Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once.||log10 copies/mL||Full Range|Median
156256|NCT00324961|Secondary|Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks|The Knodell/histological activity index (HAI) scoring system that represents the sum of scores for periportal bridging necrosis (0–10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0–4: none=0, marked=4); portal inflammation (0–4: none=0, marked=4) and fibrosis (0–4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two independent pathologists in the HBeAg negative participants with 2 sequential liver biopsies during the period of 104 weeks.|Baseline to Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 48||Points on a scale||Standard Deviation|Mean
156257|NCT00324961|Secondary|Number of Participants Achieving Histological Improvement After the 104-week Treatment|Histological improvement (defined as ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was assessed by 2 independent pathologists in the HBeAg-negative participants who underwent 2 sequential liver biopsies at baseline and week 104/withdrawal. The Knodell/histological activity index (HAI) scoring system represents the sum of scores for periportal, bridging necrosis (0–10: none=0, multilobular necrosis=10), interlobular degeneration and focal necrosis (0–4: none=0, marked=4), portal inflammation (0–4: none=0, marked=4), and fibrosis (0–4: none=0, cirrhosis=4)|Week 104|HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 104||participants|||Number
156258|NCT00324961|Primary|Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104|Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory.|Week 104|Intent-to-Treat (ITT) Population: all HBeAg participants who actually received the study medication at least once. Participants with missing data were not included in the analysis.||participants|||Number
156259|NCT00324896|Secondary|WASO|Wake after sleep onset in minutes|6 weeks|intent to treat||minutes||Standard Deviation|Mean
156260|NCT00324896|Primary|TST|Total sleep time in hours|6 weeks|intent to treat approach||hours||Standard Deviation|Mean
156261|NCT00324870|Other Pre-specified|Clinical Response Rate of SAHA and Bevacizumab|To determine the clinical response rate of SAHA and Bevacizumab in patients with metastatic renal cell carcinoma.|7 years||||||
156262|NCT00324870|Other Pre-specified|Maximum Tolerated Dose|Determine the maximum tolerated dose of SAHA|18 months from first patient dosing||||||
156264|NCT00324857|Secondary|To Examine and Compare the Effectiveness of the Proposed Intervention Strategies to Increase AA Patient Likelihood of Receiving Knee Replacement Within 12 Months of the Intervention.||12 months||||||
156265|NCT00324857|Primary|Change in Willingness.|"Change in willingness assessed using the willingness likert scale. The primary outcome was change in patient willingness to undergo total knee replacement. The willingness rating is a 5-category ordinal response scale from definitely not willing to definitely willing which was later dichotomized for analysis. Responses definitely and probably willing were combined and compared to unsure, probably not willing, and definitely not willing combined."|Follow-Up|Study sample reflects the African American, predominantly male population of the VA health care system||participants|||Number
156266|NCT00324740|Primary|Objective Response Rate|The phase II portion of the study ended early therefore the primary outcome of the objective response rate was not assessed.|Tumor measurements every 8 weeks until disease progression||||||
156267|NCT00324740|Primary|Maximum Tolerated Dose of Vorinostat in Combination With Isotretinoin|Hematologic: Any Grade 3/4 Thrombocytopenia and/or Grade 3/4 Neutropenia Non-Hematologic: Any >/= Grade3 non-hematologic toxicity considered by the investigator to be possibly related to study drug and/or any non-hematologic toxicity that results in a dose-delay of more than three weeks.|Once 2 DLT events occur in patients, the preceding dose will be designated the maximum tolerated dose (MTD).|The recommended phase II dose is vorinostat (300 mg bid) + Isotretinoin (0.5 mg/kg PO bid) three days per week||mg/kg BID|||Number
156268|NCT00324740|Primary|Dose Limiting Toxicities Associated With Vorinostat Concurrently Administered With Isotretinoin|Defined as the occurrence of one or more of the following toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Course 1, up to 28 days|||participants|||Number
156269|NCT00324701|Secondary|SCID: Structured Clinical Interview for the DSM-IV|Structured clinical interview for the DSM-IV (SCID) administered by raters blind to subject condition. Structured interviews included psychiatric assessment for depression, PTSD, panic, generalized anxiety disorder (GAD) evaluated using the DSM-IV.|12 months|Participants completing 12 month assessment||% participants with treatment response||95% Confidence Interval|Number
156270|NCT00324701|Primary|At Least a 50% Improvement From Baseline to Post-treatment on the Geriatric Depression Scale (GDS)|The Geriatric Depression Scale (GDS) is a 30-item self-report assessment designed specifically to identify depression in the elderly. Participants are asked to respond by answering yes or no in reference to how they felt over the past week. Higher scores indicate more severe depression.|8 week & 12 months|Participants completing 8 week and 12 month assessments.||% participants with treatment response||95% Confidence Interval|Number
156271|NCT00324675|Secondary|HbA1c||at baseline and after 6 and 12 mo||||||
156272|NCT00324675|Secondary|Adverse Event||every month or at occurence||||||
156273|NCT00324675|Secondary|Renal Function||at abseline and after 6 and 12 mo||||||
156274|NCT00324675|Secondary|Renal Hemodynamic||at baseline and after 6 and 12 mo of tretament||||||
156275|NCT00324675|Primary|Proteinuria||at baseline and after 6 and 12 mo of treatment|per protocol||g/24hr||Standard Error|Mean
156276|NCT00324649|Secondary|Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.||48 weeks|Treated participants.||Percentage of participants|||Number
156277|NCT00324649|Secondary|Percentage of Participants With Any Adverse Event|"Participants with treatment-emergent adverse events were analyzed. Adverse events were defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with study treatment, and were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Version 11.~Treatment-emergent adverse events were events that met one of the following criteria:~Began or worsened in severity or relationship to study drug, on or after the date of the first dose of study drug and on or before the date of the last dose of study drug plus 30 days.~Had no recorded start date."|72 weeks|Treated participants.||Percentage of participants|||Number
156278|NCT00324649|Secondary|Change From Baseline in Waist Circumference/Hip Circumference Ratio|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded. Assessment of waist and hip circumference was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.||Ratio||Inter-Quartile Range|Median
156279|NCT00324649|Secondary|Percent Change From Baseline in Hematocrit|Change = Week 48 value minus baseline value expressed as median percent change.|Baseline to Week 48|Treated participants. Missing values were excluded.||Percent change in hematocrit||Inter-Quartile Range|Median
156280|NCT00324649|Secondary|Change From Baseline in Hemoglobin|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||g/dL||Inter-Quartile Range|Median
156281|NCT00324649|Secondary|Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
156282|NCT00324649|Secondary|Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
156283|NCT00324649|Secondary|Change From Baseline in Fasting Total Cholesterol|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
156284|NCT00324649|Secondary|Change From Baseline in Fasting Serum Triglycerides|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mg/dL||Inter-Quartile Range|Median
156285|NCT00324649|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||cells/mm^3||Inter-Quartile Range|Median
156286|NCT00324649|Secondary|Percentage of Participants With Virologic Failure|Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL.|48 weeks|Treated participants.||Percentage of participants|||Number
156287|NCT00324649|Secondary|Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL||48 weeks|Treated participants.||Percentage of participants|||Number
156288|NCT00324649|Secondary|Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL||48 weeks|Treated participants. Missing values were treated as failure (i.e., as HIV-1 RNA greater than or equal to 50 copies/mL).||Percentage of participants|||Number
156289|NCT00324649|Secondary|Percentage of Days for Which Participants Were Compliant With Study Drug|Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire (SMAQ)])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated.|Baseline to Week 72|Treated participants.||Percentage of days with compliance||Inter-Quartile Range|Median
156290|NCT00324649|Secondary|Change From Baseline in Lactate Concentration|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||mmol/L||Inter-Quartile Range|Median
156291|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
156292|NCT00324649|Secondary|Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)|Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
156293|NCT00324649|Primary|Change From Baseline in Limb Fat at Week 48|Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.|Baseline to Week 48|Treated participants. Number of participants analyzed is those with baseline and post-baseline DEXA data. Last post-baseline observation carried forward (LOCF) method was used if the Week 48 limb fat value was missing.||grams (g)||Inter-Quartile Range|Median
156294|NCT00324415|Secondary|Objective Response Rate (Complete and Partial)|Number of participants with complete and partial responses based on the RECIST criteria|3 years following treatment discontinuation|||participants|||Number
156295|NCT00324415|Secondary|Anogenital Human Papilloma Virus (HPV) Infection and Anal Cytology||6 months following treatment discontinuation||||||
156296|NCT00324415|Secondary|Incidence of Opportunistic Illnesses|Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment|1 year following treatment discontinuation|||participants|||Number
156297|NCT00324415|Secondary|Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment|Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment|1 year following treatment discontinuation|The number of participants analyzed is the number for whom absolute CD4 count data were available at baseline at at 1 year after study completion||cells/mm3||Full Range|Median
156298|NCT00324415|Secondary|Toxicity|Delayed toxicities are defined as toxicities that occur over 90 days following treatment completion|90 days following treatment discontinuation|||events|||Number
156299|NCT00324415|Secondary|Quality of Life|EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life|1 year|The number of participants analyzed is the number of participants for whom quality of life questionnaires were completed at one year.||units on a scale||Standard Deviation|Mean
156300|NCT00324415|Secondary|Overall Survival|Percentage of participants who are alive at one year|1 year|||percentage of participants||95% Confidence Interval|Number
156301|NCT00324415|Secondary|Colostomy-free Survival at 1 Year|Percentage of participants who are alive and have not had a colostomy|1 year|||percentage of participants||95% Confidence Interval|Number
156302|NCT00324415|Secondary|Relapse-free Survival|Percentage of participants who are alive and have not experienced progressive disease and have not relapsed|1 year|||percentage of participants||95% Confidence Interval|Number
156303|NCT00324415|Secondary|Progression-free Survival|Progression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions.|1 year|||percentage of participants||95% Confidence Interval|Number
156304|NCT00324415|Primary|Local Failure Rate at 3 Years|Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders|3 years following treatment discontinuation|||participants|||Number
156305|NCT00324350|Secondary|Number of Participants With > 2 cm of Height Loss|Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing >2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity|5 years|Among participants in the BONE ancillary study, 6,979 participants had at least one height measurement during follow-up and were included in these analyses.||participants|||Number
156306|NCT00324350|Primary|Number of Participants With at Least One Fall|At each annual visit starting in January 2006, participants were also asked about falling: “In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?” Those who answered “yes” were also asked how many times they had fallen in the previous 12 months.|Average follow-up of 2.0 years|These analyses include results from the annual visits that occurred before Feb 5, 2008, the close of the intensive glycemia arm. Of those in the BONE ancillary study, 6,782 participants answered at least one question about falls.||participants|||Number
156307|NCT00324350|Primary|Number of Participants With at Least One Non-vertebral Fracture|The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.|Average follow-up of 3.8 years|As per protocol, pathological fractures, confirmed as occurring secondary to neoplasm, necrosis, or sepsis, and periprosthetic fractures were excluded (N=7). These analyses are limited to confirmed fractures that occurred on or before Feb 5, 2008, when the intensive glycemia intervention was ended.||participants|||Number
156308|NCT00324272|Secondary|Death.|Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident).|From day of surgery until end of study follow-up period (1st June 2010)|||Participants.|||Number
156309|NCT00324272|Secondary|Disease Recurrence.|This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010).|From date of surgery until end of study follow-up period (1st June 2010)|||Participants.|||Number
156310|NCT00324272|Secondary|Post Operative Pain Score Measured on 1st Post-operative Day.|Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 [no pain] to 10 [very severe pain]) which the patient was asked to record.|During the immediate post-operative period.|||Units on a scale.||Inter-Quartile Range|Median
156311|NCT00324272|Secondary|Number of Patients With Post-operative Complications (Excluding Lymphoedema).|Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded.|Until wound healing complete.|||Participants|||Number
156312|NCT00324272|Secondary|Length of Time Drains Remain in Situ.|The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery until date of wound drain removal.|||Days||95% Confidence Interval|Median
156313|NCT00324272|Secondary|Length of Hospital Inpatient Stay.|The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.|From date of surgery until date of discharge from hospital.|As the length of hospital stay was affected by numerous factors other than those related to the surgery itself (e.g. the patient's social circumstances), the results for this secondary outcome measure have not been presented.||Days||Standard Deviation|Mean
156314|NCT00324272|Primary|Post-operative Wound Drainage.|The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.|From date of surgery to date of wound drain removal (typically a period of approximately one week).|||ml||95% Confidence Interval|Median
156315|NCT00324259|Post-Hoc|Metabolic Flare on FDG-PET/CT as Compared to Response||Baseline and 24 hours after administration of the first dose of estradiol|"The data was combined as the outcome was not based on comparison of the two groups but comparing the overall FDG-PET/CT metabolic flare to the overall responses.~10 participants were not evaluable because early toxicity prevented response assessment and the PET data was not considered technically adequate or not available in 8 participants."||participants|||Number
156316|NCT00324259|Secondary|Overall Survival (OS)||Until patient death|This outcome measure was not analyzed as the overall survival was not reported.|||||
156317|NCT00324259|Secondary|Frequency of Response to Re-treatment With Estradiol for Patients Who Have a Secondary Response to an Aromatase Inhibitor After the First Response to Estradiol.||Every 3 months|At the time that the study was powered there was not any information on any patients who were re-treated with estradiol after having a secondary response to a aromatase inhibitor after the first response to estradiol.|||||
156318|NCT00324259|Secondary|Frequency of Response to Re-treatment With the Same Aromatase Inhibitor That Immediately Preceded Treatment With Estradiol on Protocol.|Best overall response|12 weeks post-treatment termination|Only offered to patients experiencing clinical benefit on estradiol.||participants|||Number
156319|NCT00324259|Secondary|Quality of Life (FACT-B Mean Score)|"Surveyed using the multidimensional Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire~The FACT-B (version 4) questionnaire consists of 36 items with five-point scale, ranging from 0-4, where a total score ranges from 0-144 and higher scores indicate better QoL. The total FACT-B score is the sum of scores for five subscales including: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and specific breast cancer concerns (9 items)."|Day 28|25 out of 34 participants in Arm 1 and 23 out of 32 participants completed the FACT-B questionnaire at Day 28 (4 weeks).||units on a scale||Standard Deviation|Mean
156320|NCT00324259|Secondary|Quality of Life|"Surveyed using a 6 item estrogen adverse effect questionnaire (headaches, bloating, breast tenderness, retention of fluid, nausea, and vomiting).~Used a 5-point scale ranging from 0 (not at all) to 4 (very much).~The scores from the 6 estrogen adverse effect items were summed to produce a single score, ranging from 0-24, with higher scores indicating higher adverse effects."|Baseline and Day 28|27 out of 34 participants in Arm 1 and 22 out of 32 participants in Arm 2 completed both the baseline and Day 28 (4 week) 6 item adverse effect questionnaire.||units on a scale||Standard Deviation|Mean
156321|NCT00324259|Secondary|Progression-free Survival (PFS)|"Defined as the time from treatment initiation to disease progression or death.~Time of last observation for patients remaining in the study and the time at which dose reductions, study drug termination, and withdrawal of consent occurred were treated as censored data.~Indicated as number of participants who had not progressed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks.~Progression per RECIST 1.0 = at least a 20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Up to 48 weeks|||participants|||Number
156322|NCT00324259|Primary|Clinical Benefit Rate (CR Plus PR Plus SD)|"Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0~CR = disappearance of all target lesions~PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter~SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease~SD is defined as lack of disease progression by 24 weeks."|24 weeks after start of treatment|||participants|||Number
156323|NCT00324233|Secondary|Subjectively Measured Insertion of the Catheter||||||||
156324|NCT00324233|Secondary|Subjectively Measured Handling||||||||
156325|NCT00324233|Primary|Residual Urine Measured by Ultra Sound||2|||ml||Standard Deviation|Mean
156997|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIA|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIA||percentage of participants|||Number
156326|NCT00324168|Secondary|Subgroup Analysis Predicting Best Spectacle-corrected Visual Acuity (BSCVA) as Stratified by Categories of Infiltrate/Scar Size|Best-spectacle visual acuity (BSCVA) at 3 months from enrollment is stratified by categories of infiltrate/scar size and examined by treatment arm|3 months from enrollment|||logMAR||Standard Deviation|Mean
156327|NCT00324168|Secondary|Subgroup Analysis of Best Spectacle-corrected Visual Acuity (BSCVA) by Categories of Infiltrate Depth|BSCVA measured in logMAR will be examined by categories infiltrate depth (categorized by depth percentage) by mean and standard deviation as well as in a regression model.|3 months from enrollment|||logMAR||Standard Deviation|Mean
156328|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Visual Acuity Group|Best spectacle-corrected visual acuity (BSCVA) for this subgroup analysis was measured in logMAR and then categorized by equivalent Snellen fractions|3 months from enrollment|||logMAR||Standard Deviation|Mean
156329|NCT00324168|Secondary|Subgroup Analysis Predicting 3 Month Best Spectacle-corrected Visual Acuity (BSCVA) by Causative Organism|BSCVA measured in logMAR will be estimated by causative organism (either Nocardia spp, Streptococcus pneumoniae, Moraxella spp, or Pseudomonas aeruginosa). BSCVA will be examined for each causative organism by mean and standard deviation as well as in a regression model.|3 months after enrollment|||logMAR||Standard Deviation|Mean
156330|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR Using MIC (Minimum Inhibitory Concentration) to Moxifloxacin as a Covariate|Best spectacle-corrected visual acuity (BSCVA) for this outcome is measured in logMAR (logarithm of the Minimum Angle of Resolution) in which smaller values indicate better visual acuity. Minimum inhibitory concentration (MIC) to moxifloxacin was measured by E test and a log2-transformation of MIC was used in all analyses. In this analysis we add MIC to the model examining BSCVA at 3 months.|3 months after enrollment|The study population analyzed for this outcome includes only those study subjects for whom an MIC value was available.||logMAR||95% Confidence Interval|Mean
156331|NCT00324168|Secondary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 12 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|12 months from enrollment|||logMAR||95% Confidence Interval|Mean
156332|NCT00324168|Secondary|Ocular Perforations||At the time of perforation|||participants|||Number
156333|NCT00324168|Secondary|Time to Resolution of Epithelial Defect|This outcome measured time from enrollment to resolution of the epithelial defect in days for up to 21 days. For three weeks patients were examined every 3 days for size of epithelial defect until the defect was gone.|From enrollment up to 21 days|||days||Standard Deviation|Mean
156334|NCT00324168|Secondary|Best Hard Contact Lens Corrected Visual Acuity Measured in logMAR, Correcting for Best Spectacle Corrected Visual Acuity at Enrollment|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
156335|NCT00324168|Secondary|Infiltrate/Scar Size, Correcting for Infiltrate/Scar Size at Enrollment||3 months from enrollment|||mm||95% Confidence Interval|Mean
156336|NCT00324168|Primary|Best Spectacle-corrected Visual Acuity (BSCVA) in logMAR at 3 Months, Using Best Spectacle-corrected Enrollment Visual Acuity as a Co-variate|LogMAR (logarithm of the Minimum Angle of Resolution) is a measure of visual acuity in which the smaller values indicate better visual acuity.|3 months from enrollment|||logMAR||95% Confidence Interval|Mean
156337|NCT00324155|Secondary|Time to Resolution of Grade 2-3, Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=Moderate adverse events (AEs); minimal, local or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Time to resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to database lock for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had a specific event that resolved||Weeks||95% Confidence Interval|Median
156338|NCT00324155|Secondary|Number of Participants With Grade 2-3 and Grade 3-4 Immune-related Adverse Events (irAEs) With Resolution Resolved|irAEs included the categories: gastrointestinal (GI), diarrhea, liver, endocrine, and skin. Grade 2=moderate adverse events (AEs); minimal, local, or noninvasive intervention indicated. Grade 3=severe AEs, medically significant but not immediately life-threatening. Grade 4=life-threatening consequences; urgent intervention indicated. Resolution is defined as improvement to Grade 1 or less or to the Grade at baseline (prior to treatment).|Week 1 (first dose) to 70 days after last dose up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of study drug and had this specific event||Participants|||Number
156339|NCT00324155|Secondary|Number of Participants With Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Hypersensitivity, Immune-related AEs/SAEs, and Inflammatory AEs/SAEs|AE=any new undesirable symptom, sign, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be drug-related. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Randomization=Day 1; start of treatment (first dose)=Week 1. Summarization time frame is from first dose to 70 days after last dose of study at time of 414 deaths.|Week 1 (First Dose) to 70 days after last dose of study up to data cutoff for primary endpoint (approximately 5 years)|All participants who received at least 1 dose of randomized ipilimumab or placebo and/or dacarbazine||Participants|||Number
156395|NCT00321763|Primary|Number of Subjects With New Onset of Chronic Diseases (NOCDs).|NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
158541|NCT00303823|Primary|Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer||4 months|||participants|||Number
156340|NCT00324155|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death. Analysis of OS was to be done once 416 deaths had occurred (primary endpoint). However, analysis occurred at 414 deaths (February 7, 2011), due to operational timing of the study. Median number of months of OS and associated confidence interval calculated using the method of Brookmeyer and Crowley.|Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months|All randomized participants whose survival follow-up was current (defined as having died or last known alive date occurring on or after the data cutoff date, which was when a total of 414 deaths occurred).||Months||95% Confidence Interval|Median
156341|NCT00324155|Secondary|Percentage of Participants With Brain Metastasis-Free Survival at Time of Data Cutoff|Brain metastasis-free survival was defined as the time from randomization to the date of progression with a new lesion located in the brain. New brain lesions prior to Week 12 constituted a progression event (unlike main progression-free survival analysis). A participant who dies without documentation of a brain lesion was considered to have progressed with brain metastasis on the date of death. Participants who are free of brain metastasis were censored on the date of their last tumor assessment. An independent review committee evaluated images of participants with clinical symptoms to determine the number of those free of brain metastasis. The brain metastasis-free status was reported as a percent of participants (n/N), where n= participants with metastasis-free brains at data cutoff for the Primary Endpoint and N= randomized participants. A 2-sided Clopper and Pearson confidence interval was performed.|Date of randomization up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
156342|NCT00324155|Secondary|Duration of Stable Disease (SD): Randomized Participants With Stable Disease|Duration of SD was defined in those whose Best Overall Response (BOR) was SD, per independent review committee (IRC) as the time between Week 12 and date of progressive disease (PD) or death , whichever occurs first. For those who underwent tumor resection following Week 12 but prior to PD, duration of SD was censored on date of last evaluable tumor assessment (TA) prior to resection. For those with BOR of SD at Week 12, date of PD was used in analysis of duration of SD. For those with BOR=SD who have not subsequently progressed and who remain alive, duration of SD censored on date of last evaluable TA. Modified criteria of the World Health Organization (mWHO): SD=insufficient decrease to qualify for partial response or sufficient increase to qualify for PD; PD=an increase of 25% or more in sum of products of longest diameter and greatest perpendicular diameter of index lesions compared with smallest recorded sum, or appearance of 1 or more new lesions.|Week 12 to date of disease progression or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had SD||Months||95% Confidence Interval|Median
156343|NCT00324155|Secondary|Time to Response: All Randomized Participants With Response to Treatment|Time to response was defined as the time between the first dose of study therapy and the date when measurement criteria were met for Best Overall Response (BOR) of partial response (PR) or complete response (CR), whichever occurred first, per independent review committee. Note that if an overall response of PR occurred before confirmation of CR, the time to response endpoint was not determined by the time that the BOR of CR was shown but rather by the earlier time point showing PR. Modified criteria of the World Health Organization: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline; PD=an increase of 25% or greater in the SPD of index lesions compared with the smallest recorded sum, or the appearance of 1 or more new lesions.|First dose to date of BOR up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and who had a response of CR or PR||Months||Full Range|Median
156344|NCT00324155|Secondary|Duration of Response (DOR): Randomized Participants With Response of Complete Response (CR) or Partial Response (PR)|DOR defined in those with Best Overall Response (BOR)=CR or PR per independent review committee (IRC) as time between date of response of confirmed CR or PR, whichever occurred first, and date of PD or death. If PR assessed before CR, DOR confirmed at earlier time-point showing PR. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions;no evidence of PD; PR=50% or greater decrease in the sum of products of longest and greatest perpendicular diameters (SPD) of all index lesions compared with baseline. PD=an increase of 25% or greater in SPD of index lesions compared with the smallest recorded sum, or appearance of 1 or more new lesions. Immune-related response criteria (irRC): SD=50% decrease in total measurable tumor burden compared with peak cannot be established nor 25% increase compared with nadir, in absence of unequivocal progression of nonindex lesions. Unconfirmed immune-related (ir) CR, irPR, or irPD=irSD.|Day of CR or PR to day of PD or death up to data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group and had a response of CR, PR, irCR, or irPR. n=number of participants who responded by mWHO criteria and irRC.||Months||95% Confidence Interval|Median
156345|NCT00324155|Secondary|Best Overall Response Rate (BORR)|BORR=number with Best Overall Response (BOR) of complete response (CR) or partial response (PR), divided by total number of randomized patients. BOR=date of first dose to the last tumor assessment prior to subsequent cancer therapy (including tumor resection surgery but excluding palliative local radiotherapy for bone lesions). Independent review committee assessment. Modified criteria of the World Health Organization (mWHO): CR=disappearance of all lesions; no evidence of progressive disease; PR=50% or greater decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline. Immune-related (ir) response criteria (irRC) assess tumor response in patients on immunotherapy: irCR=disappearance of all lesions in 2 consecutive observations at least 4 weeks apart; irPR=50% or greater decrease in total measureable tumor burden compared with peak in 2 observations at least 4 weeks apart.|First dose to last tumor assessment at data cutoff for primary endpoint (approximately 5 years)|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
156355|NCT00324116|Secondary|Change From Baseline in Visual Acuity|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.|Baseline, 6 weeks, 12 weeks, 54 weeks|FAS; n=number of subjects with evaluable data.||score on scale||Standard Deviation|Mean
156346|NCT00324155|Secondary|Progression-free Survival (PFS) Rate Truncated at Week 12|PFS rate=probability patient was progression-free at Day 78, calculated as total patients receiving treatment and with an overall response of stable disease (SD), partial response (PR), or complete response (CR) at Week 12, divided by total patients. For those alive and not progressed at or before Week 12, PFS censored on date of last evaluable tumor assessment (TA) at or before Week 12. Those with an assessment of PD prior to Week 12 and subsequent assessment of SD, PR, or CR at Week 12 were called progression-free at Week 12. Those with no recorded postbaseline TA dated on or before Day 109, and who had not died on or before Day 109, were censored at randomization. PD=at least 25% increase in sum of products of all index lesions or appearance of any new lesions. Both an investigator and independent review committee (IRC) assessed radiologic imaging studies, photographs of skin lesions, and clinical data. IRC assessment was considered primary over that of the investigators.|Day 78|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
156347|NCT00324155|Secondary|Median Number of Months of Progression-free Survival (PFS)|PFS=time between randomization and date of progression or death, whichever occurs first. Participants who died without reported prior progression were considered to have progressed on date of death. For those alive and not progressed, PFS was censored on date of last evaluable tumor assessment (TA). Those who have not died and have no recorded postbaseline TA were censored at randomization. Those who died without any recorded postbaseline TA were considered to have progressed on date of death. Evaluation was conducted by both investigator and an independent review committee (IRC), who assessed radiologic imaging studies, photographs of skin lesions, and clinical data. Progressive disease defined using modified criteria of the World Health Organization: demonstration of at least a 25% increase in the sum of products of all index lesions or the appearance of any new lesions. For nonindex lesions: appearance of any new lesions or unequivocal progression of nonindex lesions.|Randomization to date of progression or death to approximately 5 years|All participants who were randomized to a treatment group||Months||95% Confidence Interval|Median
156348|NCT00324155|Secondary|Disease Control Rate (DCR)|DCR=number whose best overall response (BOR) was partial response (PR), complete response (CR) or stable disease (SD), divided by all randomized participants (unevaluable participants included). Independent review committee assessment. BOR=date of first dose to last tumor assessment prior to subsequent cancer therapy (including tumor resection, excluding palliative local radiotherapy). Modified World Health Organization criteria: CR=disappearance of all lesions; no evidence of progressive disease (PD); PR=50% or more decrease in the sum of products of the longest diameter and greatest perpendicular diameter of all index lesions compared with baseline; SD=neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD; PD=at least 25% increase in sum of products of all index lesions and/or appearance of any new lesions; nonindex lesions: appearance of any new lesions and/or unequivocal progression of nonindex lesions.|First dose to last tumor assessment prior to subsequent therapy at data cutoff for Primary Endpoint (approximately 5 years)|All participants who were randomized to a treatment group||Percentage of participants|||Number
156349|NCT00324155|Secondary|Survival Rate at 1 Year, 18 Months, 2 Years, and 3 Years|The survival rate (percentage of participants alive) was defined as the probability that a participant is alive at 1 year (or 18 months, 2 years, or 3 years) following randomization and was estimated via the Kaplan-Meier method.|Date of randomization to 3 years following randomization|All participants who were randomized to a treatment group||Percentage of participants||95% Confidence Interval|Number
156350|NCT00324116|Secondary|Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25).|Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, 54 weeks or at early termination|FAS; n=number of subjects with evaluable data.||score on scale||Standard Deviation|Mean
156351|NCT00324116|Secondary|Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200)|"Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54.~Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54."|54 weeks|FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity)||participants|||Number
156352|NCT00324116|Secondary|Number of Subjects With Severe Visual Loss|Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS||participants|||Number
156353|NCT00324116|Secondary|Number of Subjects Maintaining Vision|Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS||participants|||Number
156354|NCT00324116|Secondary|Number of Subjects Gaining Vision|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.|54 weeks or at early termination|FAS||participant|||Number
156477|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||mmol/L||Inter-Quartile Range|Median
156356|NCT00324116|Primary|Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS)|Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.|Baseline, 54 Weeks|The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score.||participants|||Number
156357|NCT00324038|Primary|Average Daily Pain Scores - BS11 Pain Scores.|The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.|every day over a 12 week study duration.|||Box Scale 11 boxes||Standard Deviation|Mean
156358|NCT00323882|Secondary|Number of Participants Positive for Human Anti-Human Antibodies (HAHA) - Treated Participants|HAHA was measured by electrochemiluminescent (ECL) immunoassay for the detection of antibodies in human heparin plasma. Testing was performed on Days 1 (prior to ipilimumab infusion), 64, 85, and at completion of treatment.|Day 1 up to 2 years|All participants in the study who received either ipilimumab or radiation and had a measurement were analyzed.||participants|||Number
156359|NCT00323882|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities at Baseline and During Treatment Period - Treated Participants|12 Lead Electrocardiograms (ECGs) were performed at screening (Day -28 to Day -1), and on Day 85 during a treatment cycle, and at the end of treatment period. Clinically significant abnormalities could include atrial fibrillation, anterior fascicular block, marked sinus bradycardia, possible lateral infarct, and T-wave abnormality (other potential abnormalities were not excluded from consideration).|Baseline up to 2 years|All participants in the study who received either ipilimumab or radiation and had an ECG were analyzed.||participants|||Number
156360|NCT00323882|Secondary|Number of Participants With On-Study Serum Chemistry Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|CTC v3.0 used. On-study serum chemistry laboratories were reported after first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Alanine Aminotransferase (ALT) Units per Liter (U/L) Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST) U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Total Bilirubin micromoles per liter (µmol/L): Gr 1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase U/L: Gr 1: > 1.0 - 2.5 * ULN; Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Amylase U/L: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN. Creatinine µmol/L: Gr1: > 1.0 - 1.5*ULN; Gr2: > 1.5 - 3.0*ULN; Gr3: > 3.0 - 6.0*ULN; Gr4: > 6.0*ULN.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.||participants|||Number
156361|NCT00323882|Secondary|Number of Participants With On-Study Hematology Laboratory Tests Worst Common Terminology Criteria (CTC) Grade - Treated Participants|NCI CTC version(v) 3.0 was used to determine Grade (Gr). Screening was Day -28 to Day -1. On-study laboratories were reported after the first dose date, every 21 days during a treatment cycle, and within 70 days of last dose of study therapy (ie, Days 1, 22, 43, 64, 85, etc). Hemoglobin grams per liter (g/L): Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. White blood cells(WBC) 10^9 cells per liter (c/L): Gr1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Lymphocytes (absolute) 10^9 c/L: Gr1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Neutrophils (absolute) 10^9 c/L: Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Platelets 10^9 c/L: Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation and had a laboratory measurement were analyzed.||participants|||Number
156362|NCT00323882|Secondary|Overall Survival at Completion of Follow Up Period - Treated Participants|Overall Survival (OS) was defined as the time from the first date of study treatment until the date of death and was measured in months. For those participants who have not died, OS was censored at the last date the participant was known to be alive. Completion of follow-up for OS was a minimum time of eligibility 54 months to a maximum of 85 months.|Day 1 to 5 years post treatment|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab were analyzed.||Months||95% Confidence Interval|Median
156363|NCT00323882|Secondary|Number of Participants Who Died by Date of Primary Analysis and by Date of Completion of Follow Up - All Treated Participants|Primary analysis was conducted on data from Day 1 up to 2 years post treatment, data available as of September 2009. Final Follow-Up analysis was conducted on data up to 5 years post treatment, data available as of September 2013 (minimum time of eligibility 54 months to a maximum of 85 months). Primary causes of deaths are listed under each timepoint.|Day 1 to 5 years post treatment|Treated participants population included all participants in the study who received either ipilimumab or radiation.||participants|||Number
156393|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
156478|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||mmol/L||Inter-Quartile Range|Median
156364|NCT00323882|Primary|Number of Participants With Best PSA Response at Day 85 by Category - PSA Evaluable Participants|Response by investigator using National Cancer Institute (NCI) PSA Working Group recommendations= PSA < 50% of PSA reference value occurring on or before Day 85; response confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. Complete response (CR)=PSA < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; Partial response (PR)=PSA ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; Stable disease(SD)=No change from PSA reference; Progressive disease (PD) defined: If PSA nadir was ≥ 100% of the reference: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 85|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.||participants|||Number
156365|NCT00323882|Secondary|PSA Response Rate at Day 85 and Overall PSA Response Rate in 10 mg/kg Monotherapy and Combination Therapy|PSA response rate was defined as the number of participants with a PSA response (PR or CR) divided by the total number of PSA evaluable participants. PSA response at Day 85, as reported by the investigator, was defined as a PSA concentration < 50% of the PSA reference value occurring on or before Day 85 and this response was confirmed at least 4 weeks after the first determination. The PSA reference value was the PSA concentration measured immediately prior to treatment. Overall Response is < 50% of the PSA reference value occurring anytime after treatment was initiated and this response was confirmed at least 4 weeks after the first determination. Complete response=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after first value; Partial response=PSA concentration ≤ 50% of PSA reference value, confirmed at least 4 weeks after first determination.|Day 85, Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.||percentage of participants||95% Confidence Interval|Number
156366|NCT00323882|Secondary|Overall Tumor Response Rate in 10 mg/kg Ipilimumab Monotherapy and Ipilimumab/XRT Combination Therapy|Tumor response rate was defined as the number of participants with a best response of partial or complete response divided by the total number of tumor evaluable participants. Overall Tumor Response was defined as participants with a tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in cohorts with 10 mg/kg ipilimumab monotherapy and with 10 mg/kg ipilimumab combination therapy with XRT who received any ipilimumab and had a baseline PSA, were analyzed.||percentage of participants||95% Confidence Interval|Number
156367|NCT00323882|Secondary|Time to PSA Response at Day 85 in Participants With Complete Response (CR) or Confirmed Partial Response (PR) at Day 85|Time to PSA response was measured in months. Time to PSA response was analyzed in those participants with CR or PR at Day 85. CR=PSA concentration < 2 ng/mL, confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value.|Day 1 to Day 85|All participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab, had a baseline PSA, and had a confirmed Complete Response (CR) or Partial Response (PR) at Day 85.||Months||Full Range|Median
156368|NCT00323882|Secondary|Number of Participants With Best Overall Tumor Response by Category - Tumor Evaluable Participants|For those with measurable disease, tumor response based upon tumor lesions (per investigator) using Response Evaluation Criteria in Solid Tumors (RECIST). Best Overall=Participants with a best tumor response of CR or PR at anytime during the study. CR=Disappearance of all target lesions; PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference, baseline sum LD. For a status of CR or PR, changes in tumor measurements were confirmed by repeat studies no less than 4 weeks after the criteria for response were first met; Unconfirmed=not confirmed by repeat measurements; SD=Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 to last day of study treatment (+70 days) up to 2 years|Tumor-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had measurable disease at baseline, were analyzed.||participants|||Number
156369|NCT00323882|Secondary|Number of Participants With Best Overall PSA Response by Category - PSA Evaluable Participants|Best Overall PSA response per investigator, using NCI PSA Working Group: PSA with CR or PR at any time after treatment initiation and was confirmed at least 4 weeks after the first measurement. PSA reference=PSA measured immediately prior to treatment. CR=PSA concentration < 2 nanograms per milliliter (ng/mL), confirmed at least 4 weeks after 1st value; PR=PSA concentration ≤ 50% of PSA reference, confirmed at least 4 weeks after 1st value; Unconfirmed=not confirmed by repeat measurements; SD=No change from PSA reference value; PD = If PSA nadir was ≥ 100% of the reference value: PSA ≥ 125% of PSA reference and with a difference of absolute value of ≥ 5 ng/mL; If PSA nadir was < 100% and ≥ 50% of the reference value: PSA ≥ 125% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL: If PSA nadir was < 50% of the reference value: PSA ≥ 150% of PSA nadir and with a difference of absolute value of ≥ 5 ng/mL.|Day 1 to last day of study treatment (+70 days) up to 2 years|PSA-evaluable participants, including all participants in cohorts with monotherapy and with radiotherapy who received any ipilimumab and had a baseline PSA, were analyzed.||participants|||Number
156394|NCT00321763|Primary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.|From Day 0 to Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
158542|NCT00303823|Primary|No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months|||participants|||Number
156370|NCT00323882|Primary|Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AE (irAE) was defined as a clinically significant AE of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism. Day 1=first day of study treatment.|Day 1 to last day of study treatment (+70 days) up to 2 years|All participants in the study who received either ipilimumab or radiation were analyzed.||participants|||Number
156371|NCT00323869|Secondary|Overall Survival (OS) at 24 Months|Number of subjects surviving 2 years after treatment initiation|24 months|Includes all subjects who initiated treatment||participants|||Number
156372|NCT00323869|Secondary|Overall Survival (OS) at 12 Months|Number of subjects surviving 1 year after treatment initiation|12 months|Includes all subjects who initiated treatment||participants|||Number
156373|NCT00323869|Secondary|Time-to-First Event|Median time-to-first event, with events defined as disease progression, death, or toxicity requiring drug discontinuation|18 months|Includes all subjects who initiated treatment||months||95% Confidence Interval|Median
156374|NCT00323869|Secondary|Stable Disease (SD)|Number of subjects with SD per RECIST criteria|6 weeks|Includes all subjects who initiated treatment||participants|||Number
156375|NCT00323869|Secondary|Complete Response (CR)|Number of subjects with CR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment||participants|||Number
156376|NCT00323869|Secondary|Partial Response (PR)|Number of subjects with PR per RECIST criteria|6 weeks|Includes all subjects who initiated treatment||participants|||Number
156377|NCT00323869|Secondary|Overall Survival (OS)|To evaluate the safety of the combination regimen.|36 months|Includes all subjects who initiated treatment||months||95% Confidence Interval|Median
156378|NCT00323869|Secondary|Response Rate (CR + PR + SD)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, by computed tomography (CT); bone scan; positron emission tomography (PET) scan; and/or magnetic resonance imaging (MRI) as necessary to assess diseasE~Response determined as the number of subjects with any clinical response (CR + PR + SD) per RECIST criteria.~Complete Response (CR) = disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, or appearance of new cancer lesions~Stable Disease (SD): No significant effect, does not meet criteria for PR or PD."|6 weeks|Includes all subjects who initiated treatment||participants|||Number
156379|NCT00323869|Primary|Progression-free Survival (PFS)|Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.|18 months|Includes all subjects who initiated treatment||months||Full Range|Median
156380|NCT00321789|Secondary|Number of Participants Prescribed Cholesterol Medication|This was assessed via electronic medical record abstraction. Results could not be modeled statistically due to missing data/small cell sizes (i.e., not all participants had a prescription for medication because this was not an inclusion criterion).|11-month follow-up|||participants|||Number
156381|NCT00321789|Secondary|Number of Participants With Goal LDL-C|Assessed via non-fasting blood test. Goal is determined by 2003 National Cholesterol Education Program guidelines. Goal could be 160mg/dL for low risk (no coronary heart disease (CHD), 0-1 risk factor); 130 mg/dL for medium risk (no CHD, at least 2 risk factors); or 100 mg/dL for high risk (CHD and risk equivalents including diabetes, atherosclerotic disease, and multiple risk factors that confer a 10-year risk for CHD >20% per Framingham score).|11-month follow-up|||participants|||Number
156382|NCT00321789|Secondary|Saturated Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||percentage of calories||Standard Deviation|Mean
156383|NCT00321789|Secondary|Total Fat (%)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||percentage of calories||Standard Deviation|Mean
156384|NCT00321789|Secondary|Duration of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up|||hours per week||Inter-Quartile Range|Median
156385|NCT00321789|Secondary|Frequency of Moderate Intensity Physical Activity|Self-reported via Community Health Activities Model Program for Seniors questionnaire.|11-month follow-up|||times per week||Inter-Quartile Range|Median
156386|NCT00321789|Secondary|Fiber Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire.|11-month follow-up|||grams per day||Standard Deviation|Mean
156387|NCT00321789|Secondary|Cholesterol Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||milligrams per day||Standard Deviation|Mean
156388|NCT00321789|Secondary|Total Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||grams per day||Standard Deviation|Mean
156389|NCT00321789|Secondary|Saturated Fat (Grams/Day)|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||grams per day||Standard Deviation|Mean
156390|NCT00321789|Secondary|Caloric Intake|Self-reported, assessed via Block Brief Food Frequency Questionnaire (FFQ).|11-month follow-up|||kcal/day||Standard Deviation|Mean
156391|NCT00321789|Primary|Low-density Lipoprotein Cholesterol|assessed with non-fasting blood test|11-month follow-up|||mg/dL||Standard Deviation|Mean
156392|NCT00321763|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||subjects|||Number
156396|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .||subjects|||Number
156397|NCT00321763|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.|During the 7-day (Days 0-6) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with a documented dose and with symptom sheets completed .||subjects|||Number
156398|NCT00321763|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||fold increase||95% Confidence Interval|Geometric Mean
156399|NCT00321763|Primary|Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
156400|NCT00321763|Primary|Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||subjects|||Number
156401|NCT00321763|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.|At Days 0 and 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.||titers||95% Confidence Interval|Geometric Mean
156402|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
156403|NCT00321737|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
156404|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.||Percentage of Subjects|||Number
156405|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
156406|NCT00321737|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
156998|NCT00319735|Secondary|Perform Exploratory Molecular Correlates.|To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy.|36 months|No data was collected or analyzed for this secondary objective.|||||
156407|NCT00321737|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.||Percentage of Subjects|||Number
156408|NCT00321711|Secondary|Platelet Transfusion|Occurrence of one or more platelet transfusions from study day 1 through the interim follow-up visit (16 weeks)|Study day 1 through the interim follow-up visit (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
156409|NCT00321711|Secondary|Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period|CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
156410|NCT00321711|Secondary|Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia|Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
156411|NCT00321711|Primary|Occurrence of a Clinically Significant Thrombocytopenic Event|Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.|Treatment period (up to 20 weeks)|Full Analysis Set, composed of all randomized participants||Participants|||Number
156412|NCT00321698|Secondary|Clinical Progression-free Rate as Determined by <0.1ng PSA Results|The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment.|3, 6, 9, 12 months and annually, up to 5 years|||percentage of participants||95% Confidence Interval|Number
156413|NCT00321698|Secondary|Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures|"Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score.~AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe.~EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL."|Baseline and 12 Months Post-Prostatectomy|Scores not available for some participants||units on a scale||95% Confidence Interval|Mean
156414|NCT00321698|Secondary|Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins)|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:~The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body."|5 weeks|For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol.||Participants|||Count of Participants
156415|NCT00321698|Secondary|Clinical Response to Treatment as Measured by Urologic Examination||Regular intervals (clinical contact)||12/2020||||
156416|NCT00321698|Secondary|Long-term Safety||Regular intervals (clinical contact)||12/2020||||
156417|NCT00321698|Secondary|Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA|"All participants were combined for this assessment as pre-specified in the protocol.~The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported.~PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years"|Baseline (pre-treatment) and 1 month after surgery (post-treatment)|Pre- and post-treatment PSA values were available in 22 of 25 patients.||percentage change||95% Confidence Interval|Mean
156418|NCT00321698|Primary|Pathologic Response Rate at the Phase II Dose|"Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system:~The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b."|4-6 weeks after study treatment|||participants|||Number
156419|NCT00321698|Primary|Maximum Tolerated Dose (MTD)|"Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel.~The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling).~MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped."|5 weeks|||mg/m^2|||Number
158543|NCT00303823|Primary|Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia||4 months|||participants|||Number
156420|NCT00321685|Secondary|5-year Recurrence-free Survival Rate|Recurrence free survival is defined as time from surgery to disease recurrence or death without recurrence (whichever occurred first) among resected patients. 5-year recurrence-free survival rate is estimated using Kaplan-Meier method, with 90% confidence interval calculated using Greenwood's formula.|recurrence follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients who underwent surgery after neoadjuvant therapy||percentage of participants||90% Confidence Interval|Number
156421|NCT00321685|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from registration to death from any cause. 5-year overall survival rate is estimated using Kaplan-Meier method.|survival follow-up began after post-operative chemotherapy, assessed every 3 months for patients 3-5 years from registration, every 6 months for patients 5-10 years from registration and every 12 months for patients 10 years from registration|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
156422|NCT00321685|Secondary|Resection Rate for T4 Rectal Cancers|Resection rate is defined as number of patients with T4 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T4 rectal cancers|Assessed at surgery time|eligible and treated patients with T4 rectal cancers||percentage of participants||90% Confidence Interval|Number
156423|NCT00321685|Secondary|Resection Rate for T3 Rectal Cancers|Resection rate is defined as number of patients with T3 rectal cancer who underwent curative surgical resection among all eligible and treated patients with T3 rectal cancers|Assessed at surgery time|eligible and treated patients with T3 rectal cancers||percentage of participants||90% Confidence Interval|Number
156424|NCT00321685|Primary|Pathologic Complete Response Rate|Pathologic complete response to preoperative therapy was determined at the time of surgical resection. Pathologic complete response (pCR) is defined as no evidence of invasive cells on pathologic examination of the primary rectal cancer (or tissue from the area where the tumor had been if there is a complete clinical response). Pathologic complete response rate is calculated as number of patients achieving pathologic complete response divided by all eligible and treated patients|Assessed at surgery time|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
156425|NCT00321672|Secondary|Proportion of Subjects Reaching 30% Decrease in Their Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12||Weeks 2-12|||Percentage of Participants|||Number
156426|NCT00321672|Secondary|Absolute Change in the Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.||Weeks 2-12.|||Numeric Pain Rating Scale (0 to 10)||Standard Error|Least Squares Mean
156427|NCT00321672|Primary|The Primary Measure of Efficacy Was the Percent Change in the “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.|"Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing average pain for the past 24 hours for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain."|Weeks 2-12|Analyses were intention to treat (ITT). A modified last observation carried forward (LOCF) approach was used to impute missing data. Each NGX-4010 group was compared with its respective control group.||Percent Change from baseline||Standard Error|Least Squares Mean
156428|NCT00323739|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months|||Months||95% Confidence Interval|Median
156429|NCT00323739|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months|||Months||95% Confidence Interval|Median
156430|NCT00323635|Primary|Relationship of Incontinence to Urge or Stress|4-grade scale|Duration of study|Study prematurely stopped|||||
156431|NCT00323635|Primary|Number of Incontinence Episodes;|Number|Duration of Study|Study prematurely stopped|||||
156432|NCT00323635|Secondary|Pads Used|Pads used|Duration of Study|Study prematurely stopped|||||
156433|NCT00323635|Secondary|Whether She Used Any Pads.|Yes/No|Duration of Study|Study prematurely stopped|||||
156434|NCT00323635|Primary|Urgency|Level of urgency for 7 days, graded 1 to 4,|Beginning after the first void on the Friday morning of week 7 and week 13 of their participation;|Study prematurely stopped|||||
156435|NCT00323635|Other Pre-specified|Sleep / Wake Pattern|Wrist actigraphy measures of total daytime and nighttime activity scored by standardized Actiwatch measures of sleep and sake.|Two weeks||||||
156436|NCT00323635|Secondary|Hyperarousal|Score on 26-item self-report Hyperarousal Scale that indicates proportion of attention allocated to visceral-somatic information vs. external sensory data.|At baseline and 8 weeks later||||||
156437|NCT00323635|Secondary|Cognitive Function|Motor speed (number of finger taps in 30 seconds); Continuous Performance (mean response time elicited by appearance of target alphabet letter presented in a series of letters on a monitor screen for 1 minute); Color-Word Stroop Test (response times to stimuli with congruent word and color)|Two 20-minute sessions during 2 months||||||
156438|NCT00323635|Secondary|Sleep Quality||2 months||||||
156439|NCT00323635|Secondary|Quality of Life, Scores on the Women's Health Questionnaire.|Self-reported vasomotor symptoms, other somatic symptoms, anxiety, depression, sleep and cognitive symptoms (memory, concentration and clumsiness problems), measured as category scores. Subjective sleep onset and total sleep times measured as 7-day averaged minutes.|2 weeks||||||
156440|NCT00323635|Secondary|Psychological Self-reports, Scores on Anxiety and Depression Rating Scales;|State and Trait scores on Spielberger State-Trait Anxiety Inventory; The score measured by the Zung Self-Rating Depression Inventory.|2 weeks||04/2013||||
156441|NCT00323635|Primary|Nocturnal Urinary Frequency, Recorded on an Event/Symptom Chart;|Subjects note: 1. Number of nocturnal and diurnal voids; 2) level of urgency for 7 days, graded 1 to 4, beginning after the first void on the Friday morning of week 7 and week 13 of their participation; 3) Number of incontinence episodes; 4) Relationship of incontinence to urge or stress (4 grade scale); 4) Whether she used any pads.|2 months|Study prematurely stopped|||||
158544|NCT00303823|Primary|Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease||4 months|||participants|||Number
156442|NCT00323622|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|At Months 33 (M33) and 45 (M45) (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||Subjects|||Number
156443|NCT00323622|Secondary|Number of Subjects With Anemia.|Anemia was indicated by a hematocrit level (HL) below (<) 25%. The numbers of subjects with HL below (<) and above or equal (≥) 25 %, and with missing HL results were tabulated. In the tabulation below, the number of subjects falling into the “HL ≥25%” category corresponds to the number of subjects with anemia as asked per outcome. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||Subjects|||Number
156444|NCT00323622|Secondary|Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI)|PFMI was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The number of PFMI episodes (EPFMI) per person-year (pyr) was tabulated, using as unit EPFMI episode per pyr. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||EPFMI episode per pyr|||Number
156445|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 3 was defined as the presence of P. falciparum asexual parasitaemia above 15000 per microliter (µL) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
156446|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 2 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films in an unwell child brought for treatment with a history of fever (axillary temperature equal or above 37.5 degrees Celsius) within 24 hours or documented fever. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
156447|NCT00323622|Secondary|Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1|PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 1 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
156479|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO)|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. LOCF method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.||mmol/L||Inter-Quartile Range|Median
156448|NCT00323622|Secondary|Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition|Malaria infection by Plasmodium falciparum was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.|From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).||n/PYAR|||Number
156449|NCT00323622|Secondary|Anti-hepatitis B (HBs) Antibody Concentrations.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). Anti-HBs antibody concentration levels were measured in blood samples from Cohort 2 only.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens,with blood sample within protocol-defined time limits and available antibody measurements.||mIU/mL||95% Confidence Interval|Geometric Mean
156450|NCT00323622|Secondary|Anti-circumsporozoite Protein (CS) Antibody Concentrations.|Concentrations for anti-CS antibodies are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 0.5 EL.U/mL. Subjects were pooled across age ranges for this outcome measure.|At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens, with blood sample within protocol-defined time limits and available antibody measurements||EL.U/mL||95% Confidence Interval|Geometric Mean
156451|NCT00323622|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period: from Month 21 to Month 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).|The analysis was performed on the Total Vaccinated cohort, which included all subjects vaccinated in the primary NCT00197041 study, and re- enrolled in this follow-up NCT 00323622 study, and for whom data were available.||Subjects|||Number
156452|NCT00323609|Secondary|VCF-related Health Care Utilization|Health care utilization assessments conducted by monthly phone call to participating patients.|Monthly for 24 months post-op|Due to the early termination of the study, sponsor will not carry out the analysis of secondary healthcare utilization endpoints.|||||
156453|NCT00323609|Secondary|Change in Global Sagittal Balance.|Change in global sagittal balance as measured by sagittal vertical axis.|Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Due to the early termination of the study and having few sites able to image using 3-foot lateral films, sponsor will not carry out the analysis of global sagittal balance in the clinic report.|||||
156454|NCT00323609|Secondary|Change in Vertebral Body Local Cobb Angle (LCA)||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Local Cobb Angle' represents number of subjects with radiographic data available for analysis.||degree|Participants|Standard Deviation|Mean
156455|NCT00323609|Secondary|Change in Vertebral Body Kyphosis Angle||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Kyphosis Angle' represents number of subjects with radiographic data available for analysis.||degree|Participants|Standard Deviation|Mean
156456|NCT00323609|Secondary|Change in Posterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Posterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.||mm|Participants|Standard Deviation|Mean
156457|NCT00323609|Secondary|Change in Middle Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Middle Vertebral Body Height' represents number of subjects with radiographic data available for analysis.||mm|Participants|Standard Deviation|Mean
156458|NCT00323609|Secondary|Change in Anterior Vertebral Body Height||Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Anterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.||mm|Participants|Standard Deviation|Mean
156480|NCT00323492|Primary|Change From Baseline to Week 12 in Fasting Triglycerides|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Last post-baseline observation carried forward (LOCF) method was used for the analysis if the Week 12 value was missing. A missing datum were replaced by the last post-baseline value.||mmol/L||Inter-Quartile Range|Median
156459|NCT00323609|Secondary|Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days|Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.||percentage of participants|||Number
156460|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months||24 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 24-months is indicated.||percentage of participants|||Number
156461|NCT00323609|Secondary|Rate of Serious Adverse Events at 30 Days|Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.|30 days post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out.||percentage of participants|||Number
156462|NCT00323609|Secondary|Quality of Life -- EQ5D Index|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
156463|NCT00323609|Secondary|Quality of Life by SF-36|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
156464|NCT00323609|Secondary|Back Function-Oswestry Disability Index|The Oswestry Disability Index (ODI) Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
156465|NCT00323609|Secondary|Back Pain|Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).|7 days, 30 days, 3 months, 12 months, 24 months post-operation|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.||units on a scale||Standard Deviation|Mean
156466|NCT00323609|Primary|Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months||12 months|Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 12-months is indicated.||percentage of participants|||Number
156467|NCT00323557|Primary|Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine|Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of >0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.|Baseline and at 1 month after vaccine.|||participants|||Number
156468|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48||48 weeks|ITT. Missing values were treated as failure.||Percentage of participants|||Number
156469|NCT00323492|Secondary|Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12||12 weeks|ITT. Missing values were excluded. Any subjects with plasma HIV-1 RNA greater than or equal to 400 copies/mL at Week 12 were to have virologic genotyping performed.||Percentage of participants|||Number
156470|NCT00323492|Secondary|Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12||12 weeks|ITT. Missing values were treated as failure.||Percentage of participants|||Number
156471|NCT00323492|Secondary|Change From Baseline to Week 48 in CD4 Cell Count|Change = Week 48 value minus baseline value.|Baseline to Week 48|ITT. Missing values were excluded.||cells/mm^3||Inter-Quartile Range|Median
156472|NCT00323492|Secondary|Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count|Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||cells/mm^3||Inter-Quartile Range|Median
156473|NCT00323492|Secondary|Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12|Centralized laboratory assessment|12 weeks|ITT. Missing values were excluded.||Percentage of participants|||Number
156474|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP)|Local laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded. Assessment of us-CRP was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.||mg/L||Inter-Quartile Range|Median
156475|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
156476|NCT00323492|Secondary|Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO|Centralized laboratory assessment. Change = Week 12 value minus baseline value.|Baseline to Week 12|ITT. Missing values were excluded.||Ratio||Inter-Quartile Range|Median
156485|NCT00323479|Secondary|Functional Index of Cochin at 12 Months in Patients Under Anastrozole.|Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.|12 months|||Units on scale||Standard Deviation|Mean
156486|NCT00323479|Primary|Number of Participants With New Events of Arthralgia||12 months|||Participants|||Number
156487|NCT00323427|Primary|Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Non-verbal Strategies subscale describe adaptive coping strategies but they describe unobtrusive, nonverbal behaviors that the individual can use to maximize communication effectiveness.~8 week change score from baseline value.~Larger values of the change score indicate more use of adaptive non-verbal behaviors.~Larger group mean change score indicates BETTER performance on this scale.~The CPHI Non-verbal strategies score ranges from 1 (worse) to 5 (better) usage of non-verbal strategies."|8-weeks post-baseline relative to baseline|Intent-to-Treat||score on a scale.||Standard Deviation|Mean
156488|NCT00323427|Primary|Communication Profile for Hearing Impaired: Verbal Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Verbal Strategies subscale describe adaptive strategies for coping with the effects of hearing impairment on communication.~8 week change score from baseline value.~Larger values of the change score indicate more use of adaptive Verbal Strategies.~Larger group mean change score indicates BETTER performance on this scale.~CPHI Verbal Strategies scores vary from 1 (worse) to 5 (best) strategy usage."|8 weeks post-baseline relative to baseline|Intent to treat||score on a scale||Standard Deviation|Mean
156489|NCT00323427|Primary|Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale|"The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others.~The Maladaptive strategies subscale describe behaviors that prevent the individual from coping effectively with communication problems.~8 week change score from baseline value. Larger values of the change score indicate less use of maladaptive behaviors. Larger group mean change score indicates BETTER performance on this scale.~CPHI Maladaptive strategies subscale ranges from 1 (better) to 5 (worse) maladaptive strategy usage."|8 weeks post-baseline relative to baseline|Intent-to-treat (ITT)||score on a scale||Standard Deviation|Mean
156490|NCT00321646|Secondary|PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy.|The rate of PSA decline by 50% compared to baseline PSA.|after 6 months of ajuvant chemotherapy.|||proportion of participants||95% Confidence Interval|Number
156491|NCT00321646|Primary|Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy|A response was defined as a decrease in tumor size of >50% for the largest lesion in the prostate by endorectal MRI.|after 6 months of neoadjuvant chemotherapy.|||proportion of participants||95% Confidence Interval|Number
156492|NCT00321620|Secondary|Time to the First-And-Subsequent On-Study SRE|"Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.~This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events."|Up to 40.5 months|Full Analysis Set, composed of all randomized participants||Events|||Number
156493|NCT00321620|Secondary|Time to the First On-Study SRE (Superiority)|Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants||Days||95% Confidence Interval|Median
156494|NCT00321620|Primary|Time to the First On-Study SRE (Non-inferiority)|Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.|Up to 40.5 months|Full Analysis Set, composed of all randomized participants||Days||95% Confidence Interval|Median
156495|NCT00321464|Secondary|Time to First and Subsequent On-Study Skeletal-Related Event|Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative number of events.|Up to 34 months|Full Analysis Set, composed of all randomized participants||Events|||Number
156496|NCT00321464|Secondary|Time to First On-Study Skeletal-Related Event (Superiority)|Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.||Participants|||Number
156497|NCT00321464|Primary|Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)|Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.|Up to 34 months|Full Analysis Set, composed of all randomized participants.||Participants|||Number
156498|NCT00323362|Secondary|1-year Survival|Accrual duration is 2 years with an additional year for assessment of 1-year survival. Outcome measure time frame is about 3 years.|3 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.||percentage of patients|||Number
156499|NCT00323362|Secondary|Time to Progression||2 years|The study was closed early due to toxicity and insufficient data were collected to analyze this outcome measure.||months||Standard Deviation|Mean
156500|NCT00323362|Primary|Percentage of Patients Who Meet Critieria for Response|"Response is considered Partial Response or Complete Response as per RECIST criteria.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years|Fourteen subjects were evaluable for response. Three subjects were not assessed.||percentage of patients who responded|||Number
156502|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156503|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156504|NCT00323310|Primary|Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156505|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156506|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156507|NCT00323310|Primary|Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose|pre-dose to immediately post dose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156508|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156509|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156510|NCT00323310|Primary|Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1|5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose|pre-dose and immediately postdose|Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.||Units on a Scale (0 to 4)|Participants|Standard Deviation|Mean
156511|NCT00323297|Secondary|One Year Survival From the Start of Sildenafil Treatment.|The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.||Participants who died|||Number
156512|NCT00323297|Secondary|One Year Survival Probability From the Start of Sildenafil Treatment.|The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil.|One year from the time of starting sildenafil|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.||Probability of death||90% Confidence Interval|Number
156513|NCT00323297|Secondary|Change From Baseline in Borg Dyspnea Score at Week 12|"Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);~(very slight);~(slight breathlessness);~(moderate); 4 (some what severe);~5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum)."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach.||Units on a scale||Standard Deviation|Mean
156514|NCT00323297|Secondary|Clinical Worsening Events|"No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead.~Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy."|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication.||Participants|||Number
156515|NCT00323297|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class.|Week 12|ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the LOCF approach.||Participants|||Number
156516|NCT00323297|Primary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12|6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.|Week 12|Intent-to-Treat (ITT) Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward (LOCF) approach. Statistical analysis was carried out on LOCF values.||Meters||Standard Deviation|Mean
156517|NCT00323284|Secondary|Efficacy|Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months|12 months|Intent to treat population using non-responder approach||percent||95% Confidence Interval|Number
156518|NCT00323284|Primary|Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds|Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months|12 months|Intent to treat analysis of all enrolled subjects using non-responder approach||percent of subjects achieving endpoint||95% Confidence Interval|Number
156519|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|Baseline to Post Treatment (12 weeks)|Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates||units on a scale||Standard Deviation|Mean
156520|NCT00323271|Primary|Pain Intensity|The Numeric Rating Scale of pain intensity (NRS-I) is an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable). Participants were asked to rate their usual, worst and least pain over the past week. The average of these numbers will serve as the primary outcome measure.|baseline|||units on a scale||Standard Deviation|Mean
156521|NCT00323258|Secondary|Death in Intervention Patients Compared to Usual Care|Number of patients who died in each treatment group prior to the 6 month follow-up time point.|6 months|||participants|||Number
156522|NCT00323258|Secondary|Percent of Patients Adherent to Statin Via Refill Records|"According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.~% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.||percentage of patients with >or=75%|||Number
156523|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker Via Refill Records|"According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account.~% adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes"|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.||percentage of patients with PDC >or=75%|||Number
156524|NCT00323258|Secondary|Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records|Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy|6 months|Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.||percentage of participants|||Number
156525|NCT00323258|Primary|Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months|Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist|6 months|Those participants alive and able to speak to pharmacist on 6 month follow up phone call. Missing (n=35)- Could not be reached: 12 intervention and 11 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Died during call period: 2 intervention and 1 usual care, refused to participate in call: 1 intervention and 5 usual care.||percentage of participants|||Number
156526|NCT00323193|Secondary|Impact of Weight on Quality of Life Survey (IWQOL)|Raw scores for this measure were converted to a range from 0 to 100, with higher scores indicating lower impact of weight on quality of life.|baseline and six months|||units on a scale||Standard Deviation|Mean
156527|NCT00323193|Primary|Weight Measurement|Weight taken at the baseline assessment and again at the 6 month assessment|baseline and six months|||pounds||Standard Deviation|Mean
156528|NCT00323115|Secondary|Radiological Response When There is Residual Enhancing Tumor at Baseline MRI||MRI post vaccine||||||
156529|NCT00323115|Secondary|Immunological Parameters With PFS vs Overall Survival||Evaluable patients for immunologic parameters are those who have completed 3 vaccines||||||
156530|NCT00323115|Secondary|Progression Free Survival (PFS)and Overall Survival (OS) Comparison to Prognostic Matched Historical Controls|PFS will be assessed for each patient as the time from surgery until the patient reaches objective disease progression by MRI, defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of contrast enhancement of any lesion or any new enhancing tumor on MRI or CT scans.|From Enrollment - March 2011|Surviving patients with no disease progression as of 3/11 - the date used for data collection for publication.||participants|||Number
156531|NCT00323115|Secondary|Feasibility and Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination||Pheresis||||||
156532|NCT00323115|Primary|Tumor-specific Cytotoxic T-cell Response|MRI & pheresis post vaccine|Day 42|All participants who received all 3 vaccine administrations were used in this data analysis.||10^9 cells/L||Full Range|Median
156533|NCT00323037|Secondary|Drug Compliance||Up to 32 weeks (titration and maintenance phases)||||||
156534|NCT00323037|Secondary|Safety and Tolerability of Coreg CR||24 weeks after entry into the maintenance phase (after unblinding)||||||
156535|NCT00323037|Secondary|Drug Dose Tolerability||Up to 32 weeks (titration and maintenance phases)||||||
156536|NCT00323037|Secondary|Hospitalizations From All Causes||Up to 32 weeks (titration and maintenance phases)||||||
156537|NCT00323037|Secondary|Incidence of Hospitalizations From Exacerbation of Heart Failure||Up to 32 weeks (titration and maintenance phases)||||||
156538|NCT00323037|Secondary|Change From Baseline in BNP Levels||24 weeks after entry into the maintenance period||||||
156539|NCT00323037|Secondary|Change From Baseline in Left Ventricular Remodeling (IVST, PWT, LVM, ESV, EDV, EDVI, ESD, EDD, Deceleration Time, and E:A Ratio)||24 weeks after entry into the maintenance period||||||
156540|NCT00323037|Secondary|Change From Baseline in Left Ventricular Ejection Fraction||24 weeks after entry into the maintenance period||||||
156541|NCT00323037|Primary|Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography|Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.|24 weeks after entry into the maintenance period|Analysis was performed on the modified intent to treat population (mITT), which were those subjects with both a Baseline and an evaluable End of Study echocardiogram.||mL/m^2||Standard Deviation|Mean
156542|NCT00322881|Primary|Therapy Completion Rate|The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.|6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
156543|NCT00322855|Primary|To Review the Outcome of Patients With Soft Tissue Sarcoma Treated With Chemotherapy From 2004 and 2005||up to one year|Study was terminated due to low accrual. This is not an applicable trial; no results to report|||||
156999|NCT00319735|Secondary|Evaluate Toxicity|To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|Grade 3 toxicities occurring in >5% of participants are reported. Safety data is presented in totality in the adverse events section.||participants|||Number
156544|NCT00322842|Secondary|Increase in Peripheral Blood (PB) CD34+ Cells From Steady-state Hematopoiesis to Pre-leukapheresis in G-CSF+Plerixafor Treated Participants Compared to Historical Controls Treated With G-CSF Alone or Chemotherapy and G-CSF|A comparison of the effectiveness in mobilizing peripheral blood CD34+ cells between this study's treatment regimen (G-CSF plus plerixafor) to other treatment options: G-CSF alone, and chemotherapy with G-CSF.|up to day 8|Analysis was not performed. Historical data was not available.|||||
156545|NCT00322842|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who had transplants and engraftment data 12 months after transplantation||participants|||Number
156546|NCT00322842|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants.||number of transplants|Participants||Number
156547|NCT00322842|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who had transplants. Fifteen participants had tandem transplants. The date of initial PMN engraftment was missing for 11 transplants, which were later shown to have durable grafts.||number of transplants|Participants||Number
156548|NCT00322842|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median total number of CD34+ cells collected during apheresis as measured by a central lab.|Days 5-8|Intent to treat population. Samples from two participants were not analyzed by the central lab.||CD34+ cells (*10^6 / kg)||Full Range|Median
156549|NCT00322842|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL After First Dose of Plerixafor|The fold increase was measured using local lab values and is the ratio of post first dose (pre-apheresis) PB CD34+ cells/µL)/pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population||ratio||Full Range|Median
156550|NCT00322842|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 step scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population - all participants who received at least 1 dose of plerixafor.||participants|||Number
156551|NCT00321373|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort which included all vaccinated subjects.||Subjects|||Number
156552|NCT00321373|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.|During the entire study period (Day 0 to Day 180)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects.||Subjects|||Number
156553|NCT00321373|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) follow up period after vaccination|The analysis was based on the Total vaccinated Cohort which included all vaccinated subjects with the symptom sheet completed.||Subjects|||Number
156554|NCT00321373|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort that included all vaccinated subjects with the symptom sheet completed.||Subjects|||Number
156555|NCT00321373|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Day 180 post-vaccination.|The analysis was based on the ATP cohort for immunogenicity at Day 180 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.||titer||95% Confidence Interval|Geometric Mean
156622|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset|At all study visits, unsolicited adverse events were recorded.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
156556|NCT00321373|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus|Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0 and 21 post-vaccination|The analysis was based on the ATP cohort for immunogenicity at Day 21 including subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at this time point.||titer||95% Confidence Interval|Geometric Mean
156557|NCT00321321|Primary|Insulin Secretion|area under the curve AUC and insulin secretion rate|0 - 90 minutes|||pmol/l * 90 minutes|||Number
156558|NCT00322777|Secondary|Remission|Remission of depression was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). Remission was based on a HAM-D score of less than 7. Remission is indicated as a percentage of participants at each time point whose scores were below 7.|baseline, 8 weeks, 16 weeks, and 24 weeks|||percentage of participants score < 7|||Number
156559|NCT00322777|Secondary|Response Rate|Response rate was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). A response was determined as a reduction in the HAM-D score by at least 50% from the baseline score. The data are presented as the percentage of participants with response at each time point as compared to baseline.|baseline, 8 weeks, 16 weeks, and 24 weeks|||percentage of participants with response|||Number
156560|NCT00322777|Primary|Hamilton Depression Rating Scale - Depression Severity|"Depression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. Total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression.~The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants’ allocation."|baseline, 8 weeks, 16 weeks, and 24 weeks|||units on a scale||Full Range|Mean
156561|NCT00322712|Primary|Time to Death|Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week.|From date of treatment until time of death|||Months||Full Range|Median
156562|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||kilograms (kg)||Standard Deviation|Mean
156563|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||mm Hg||Standard Deviation|Mean
156564|NCT00322621|Secondary|Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||mm Hg||Standard Deviation|Mean
156565|NCT00322621|Secondary|Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint||Baseline (Week 0), Week 34|All patients who received either 60 mg or 120 mg duloxetine once daily.||beats per minute||Standard Deviation|Mean
156566|NCT00322621|Secondary|Number of Participants Discontinuing in Maintenance / Rescue Phase||Baseline (Week 8) to Week 34|Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34)||participants|||Number
156567|NCT00322621|Secondary|Number of Participants Discontinuing in the Acute Phase||Baseline (Week 0) to Week 8|Participants in Acute Phase (through Week 8).||participants|||Number
156568|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156569|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint|A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156570|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156571|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint|This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).|Baseline (Week 8), Week 34|Number of responders with a baseline and ate least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156572|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156573|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156574|NCT00322621|Secondary|Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156575|NCT00322621|Secondary|Maintenance Arm: Patient’s Global Impressions of Improvement (PGI-I) at Week 34 Endpoint|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 34|Number of responders with at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156576|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156577|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint|A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156578|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156579|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156580|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156581|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156582|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156583|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156584|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156585|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156586|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156587|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156588|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156589|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156590|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156591|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint|A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156592|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156593|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156594|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156595|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156596|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156798|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
156597|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156598|NCT00322621|Secondary|Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156599|NCT00322621|Secondary|Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint|A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156600|NCT00322621|Secondary|Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||participants|||Number
156601|NCT00322621|Secondary|Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 0), Week 34|Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||participants|||Number
156602|NCT00322621|Primary|Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint|Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline (Week 8), Week 34|Patients entering maintenance phase on duloxetine 60 mg QD. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.||units on a scale||Standard Deviation|Mean
156603|NCT00322556|Primary|Number of Subjects With Clinically Significant Changes in Vital Signs.|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Before, during, and after each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.||Participants|||Number
156604|NCT00322556|Secondary|Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.|Mean IgG trough concentration. For this analysis, each subject’s values were first aggregated to their median and the median values were then analyzed.|Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.|The ITT data set comprised all subjects treated with the study drug for which serum IgG information was available.||g/L||Full Range|Mean
156605|NCT00322556|Secondary|Annualized Rate of Any Infection.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Infections were classified as all AEs with the system organ class “infections and infestations” and AEs with the preferred term “conjunctivitis”."|For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug.||Infections per subject year|Participants||Number
156606|NCT00322556|Secondary|Number of Days of Hospitalization.||For the duration of the study, up to approximately 29 months|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.||Days||Full Range|Median
156607|NCT00322556|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.||For the duration of the study, up to approximately 29 months.|The ITT data set comprised all subjects treated with the study drug. The patient diary (in which the number of days was recorded) was not available for 1 subject so the analyzed population was reduced from 55 to 54 subjects for this outcome measure.||Days||Full Range|Median
156608|NCT00322556|Secondary|Annualized Rate of Acute Serious Bacterial Infections.|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 29 months|The Intention-To-Treat (ITT) data set comprised all subjects treated with the study drug||Infections per subject year|Participants||Number
156609|NCT00322556|Primary|Rate of AEs by Severity and Relationship|"The AE rate was the number of AEs over the number of infusions administered.~Mild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.~At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs."|For the duration of the study, up to approximately 29 months|The SDS comprised all subjects treated with the study drug.||AEs per infusion|Participants||Number
156610|NCT00322556|Primary|Influence of Infusion Rate on Temporally-Associated AEs|"The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min).~AEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion."|Within 72 hours after each infusion|'New subjects’ could receive IgPro10 at up to 4 mg/kg/min. 'Old' subjects (ie, those treated with the study drug who participated in a preceding, pivotal, Phase III clinical study with intravenous IgPro10 [study number ZLB03_002CR, NCT00168025]), could receive IgPro10 at up to 12 mg/kg/min at the discretion of the Investigator.||Infusions|Participants||Number
156611|NCT00322556|Primary|The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).|AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.|During each infusion, and within 48 or 72 hours after the end of each infusion.|The Safety Data Set (SDS) comprised all subjects treated with the study drug.||Proportion of infusions|Participants||Number
156612|NCT00322491|Other Pre-specified|Number of Participants With Durable Engraftment 12 Months After Transplantation|The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.|Approximately 13 months (12 months post-transplant )|Participants who received plerixafor, underwent transplantation, and were evaluable 12 months post transplant. The one participant who did not have a durable graft at 12 months had received chemotherapy for relapse approximately 9 months after transplantation.||participants|||Number
156613|NCT00322491|Other Pre-specified|Number of Transplants in Which Participants Achieved Platelet (PLT) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for platelet (PLT) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|A total of 47 participants were transplanted. Two participants in the MM group received a second transplant using cells collected on study. One participant in the MM group did not have PLT engraftment information recorded, however did report a durable graft at month 12 post transplant.||number of transplants|Participants||Number
156614|NCT00322491|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Participants who received a transplant. Two participants in the MM group received a second transplant.||number of transplants|Participants||Number
156615|NCT00322491|Other Pre-specified|Median Cumulative Number of CD34+ Cells Collected During Apheresis|Median cumulative total number of CD34+ cells collected during apheresis.|Days 5-8|Participants who received at least one dose of plerixafor||CD34+ cells (*10^6 / kg)||Full Range|Median
156616|NCT00322491|Secondary|Number of Participants Achieving a Two-Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL Following the First Dose of Plerixafor|The number of participants mobilized with G-CSF + plerixafor injection who have a ≥ 2-fold increase in CD34+ cells. Fold increase was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL) / (pre-plerixafor dosing PB CD34+ cells/µL)|Days 4-5 (first dose of plerixafor to apheresis)|The intent-to-treat population (defined as participants who received at least 1 dose of plerixafor).||participants|||Number
156617|NCT00322491|Primary|Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)|Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy (approximately day 38). AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').|Day 1 to approximately Day 38 (before start of chemotherapy)|Safety population – all participants who received at least 1 dose of plerixafor.||participants|||Number
156618|NCT00322465|Secondary|Specimens for Future Studies to Determine the Role of Unique and Novel Pathogens in the Etiology of Non-gonococcal Urethritis|Urethral swabs and urine specimens collected at each study visit for future studies to determine the role of unique and novel pathogens in the etiology of non-gonococcal urethritis|Baseline (enrollment); First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)||||||
156619|NCT00322465|Primary|Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.~Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).~Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent to treat: all subjects randomized who received at least one dose of study drug therapy or placebo||Percentage of participants|||Number
156620|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
156621|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
156623|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Logistic multiple regression with independent variable selection based on single variable models with p<0.10. Participants positive at enrollment for Mycoplasma genitalium from urine specimen. Potential variables: discharge amount and appearance; condom use last sex; new recent partner, number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.||Participants|||Number
156624|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Trichomonas Vaginalis in Men With Non-gonococcal Urethritis|Trichomonas vaginalis was determined from urethral swab or urine specimen. Clinical, behavioral, and demographic predictors considered included discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days and last 3 months; number of times vaginal sex, oral sex, or anal sex in last 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline results.||Participants|||Number
156625|NCT00322465|Secondary|Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Clinical, behavioral, and demographic variables considered were discharge amount and appearance; condom use last sex; new recent partner; number of partners and new partners in last 30 days as well as last 3 months; number of times vaginal sex, oral sex, or anal sex in past 30 days; always/almost always used condom in last 3 months.|Baseline (enrollment visit)|All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures.||Participants|||Number
156626|NCT00322465|Secondary|Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Mycoplasma genitalium at baseline (enrollment)|Baseline (enrollment)|All study participants with evaluable baseline test results.||Percentage of participants|||Number
156627|NCT00322465|Secondary|Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Trichomonas vaginalis from a urethral swab or urine specimen at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.||Percentage of participants|||Number
156628|NCT00322465|Secondary|Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis|Percentage of men with non-gonococcal urethritis that had a positive result for Chlamydia trachomatis at baseline (enrollment)|Baseline (enrollment visit)|All study participants with evaluable baseline test results.||Percentage of participants|||Number
156629|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.||Percentage of participants|||Number
156630|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.||Percentage of participants|||Number
156631|NCT00322465|Secondary|Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole|Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline.|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Participants who were positive at baseline, returned for follow-up, and had evaluable test results.||Percentage of participants|||Number
156632|NCT00322465|Secondary|Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole)|"Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit.~Clinical Failure at first follow-up: [Persistent symptoms AND >= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs).~Clinical Failure at second follow-up: >= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs)"|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Percentage of participants|||Number
156633|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
156634|NCT00322465|Primary|Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea|At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).|First follow-up visit (Day 15-19), second follow-up visit (Day 35-45)|Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo||Participants|||Number
157000|NCT00319735|Secondary|Time to Relief of Dysphagia|To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab|36 months|No data was collected or analyzed for this secondary objective.|||||
156635|NCT00322452|Secondary|Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.||Participants|||Number
156636|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.||Participants|||Number
156637|NCT00322452|Secondary|Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire|Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit|FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.|Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.||Participants|||Number
156638|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases|Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156639|NCT00322452|Secondary|Vomiting|Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156640|NCT00322452|Secondary|Nausea|Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156641|NCT00322452|Secondary|Diarrhoea|Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156642|NCT00322452|Secondary|Rashes/Acnes|Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156643|NCT00322452|Secondary|Neurotoxicity|Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156644|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia|Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156645|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia|Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156646|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia|Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156647|NCT00322452|Secondary|Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia|Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).|Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel|Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).||Participants|||Number
156648|NCT00322452|Secondary|Objective Tumour Response Rate According to RECIST|Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.||Participants|||Number
156649|NCT00322452|Secondary|Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)|Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here.|Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.|Analysis was carried out on Intention-to-treat (ITT) population.||Months||95% Confidence Interval|Median
156650|NCT00322452|Primary|Median Progression Free Survival (PFS) in Months|PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.|Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).|Analysis was carried out on Intention-to-treat (ITT) population.||Months||95% Confidence Interval|Median
156651|NCT00322439|Secondary|Percentage of Body Surface Area Affected by Psoriasis|Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of body surface area||Standard Error|Mean
156652|NCT00322439|Secondary|Work Productivity and Activity Impairment (WPAI)|The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n), and who were employed (for the first 3 scores).||units on a scale||Standard Error|Mean
156876|NCT00320489|Secondary|Participants Discontinuing Because of an Adverse Event (AE) or Death||Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
156653|NCT00322439|Secondary|Healthcare Resource Use|"This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:~How many times have you been to any physician’s office or urgent care clinic, not including your dermatologist?~How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor?~How many times have you received care from a health professional (HP) in your home?~How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?~How many times have you had a friend or family member take time off work to provide care or transportation?"|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||times||Standard Error|Mean
156654|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||units on a scale||Standard Error|Mean
156655|NCT00322439|Secondary|Euroqol-5D (EQ-5D) Total Score|EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered ‘3’ for all questions) to 1.0 (ie, answered ‘1’ for all questions), where 1.0 represents perfect health.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||units on a scale||Standard Error|Mean
156656|NCT00322439|Secondary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.|Baseline, Year 3 and Year 5|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of participants|||Number
156657|NCT00322439|Secondary|Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1|The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of participants|||Number
156658|NCT00322439|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Baseline and at 3 and 5 years|Participants who received at least one registry dose of etanercept, excluding participants who were enrolled at sites that were closed for cause, and with available data at each time point (indicated by n).||percentage of participants|||Number
156659|NCT00322439|Secondary|Five-year Cumulative Incidence for Events of Medical Interest (EMIs)|Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.|5 years|Full analysis set||proportion of participants||95% Confidence Interval|Number
156660|NCT00322439|Primary|Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events|A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor’s opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).|5 years|||proportion of participants||95% Confidence Interval|Number
156661|NCT00322387|Secondary|Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant|Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.|2 months|Intent to treat population. Six participants with MM had 2 transplants.||transplants|Participants||Number
156662|NCT00322387|Secondary|Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL|The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).|Days 4-5 (first dose of plerixafor to apheresis)|Intent to treat population. One participant in the Non-Hodgkin's Lymphoma (NHL): Plerixafor AM treatment group and 3 participants in the Multiple Myeloma (MM): Plerixafor After Chemo treatment group did not have samples taken for PB CD34+ cell counts on Day 1 and therefore could not be included.||ratio||Standard Deviation|Mean
156663|NCT00322387|Primary|Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant|Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.|13 months|Safety population who received at least one dose of plerixafor.||participants|||Number
156664|NCT00322374|Secondary|Number Of Participants With Tumor Response by Duration of Response Category|Duration of response was defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.||participants|||Number
156665|NCT00322374|Secondary|Duration of Tumor Response|Defined as the interval measured from the time that the measurement criteria are first met for CR or PR, whichever occurs first, until the date of documented progressive disease or death. CR= disappearance of all target lesions; PR= ≥30% decrease in the sum of the longest diameter of target lesions.|Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease.|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.||months||Full Range|Median
156666|NCT00322374|Secondary|Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease|Information on all tumor lesions was obtained at baseline by radiologic techniques, or if appropriate by physical examination (e.g. subcutaneous nodules). Measurable tumors were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, wherein complete response (CR) = disappearance of all target lesions; partial response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD)= ≥20% increase in the sum of the longest diameter of target lesions, and stable disease (SD) = small changes that do not meet above criteria.|From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2|Participants with measurable disease who received any treatment, as well as response evaluable participants. Evaluations were based on tumor measurements collected on the case report form using RECIST incorporating the use of target/non-target lesions.||participants|||Number
156667|NCT00322374|Secondary|Epirubicin Vss|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||liters||Standard Deviation|Mean
156668|NCT00322374|Secondary|Epirubicin CLT|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||L/h||Standard Deviation|Mean
156669|NCT00322374|Secondary|Epirubicin T-Half|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of epirubicin administered IV dose 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||hours||Standard Deviation|Mean
156670|NCT00322374|Secondary|Epirubicin AUC(INF)|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=the area under the plasma concentration-time curve from time zero extrapolated to infinity of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng·h/mL||Standard Deviation|Mean
156671|NCT00322374|Secondary|Epirubicin Cmax|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of epirubicin administered IV 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng/ml||Standard Deviation|Mean
156672|NCT00322374|Secondary|Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Vss= Volume of distribution at steady-state of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||liters||Standard Deviation|Mean
156913|NCT00320411|Secondary|6-month Progression Free Survival|The percentage of participants without progression or deaths at 6 months (24 weeks) after the start of dosing.|Baseline to Month 6 (Week 24)|ITT Population||percentage of participants|||Number
156673|NCT00322374|Secondary|Clearance (CLT) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. CLT= Total body clearance from plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||L/h||Standard Deviation|Mean
156674|NCT00322374|Secondary|Terminal Half-life (T-Half) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=terminal-phase elimination half-life in plasma of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||hours||Standard Deviation|Mean
156675|NCT00322374|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone|PK is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng·h/mL||Standard Deviation|Mean
156676|NCT00322374|Secondary|Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone|Pharmacokinetics (PK) is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of single-dose ixabepilone administered with IV dose of epirubicin 75 mg/m^2, derived from plasma concentration versus time data.|From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion.|Participants who had received any treatment with ixabepilone and epirubicin and had adequate concentration profiles.||ng/ml||Standard Deviation|Mean
156677|NCT00322374|Secondary|Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation|AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).SAE= any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event|Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug.|All participants who received at least 1 cycle of therapy were evaluable for safety; adverse events and other symptoms were graded according to CTCAE Version 3.0.||participants|||Number
156678|NCT00322374|Primary|Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)|The MTD was the highest dose in which 0/6 or 1/6 participants experienced DLT with at least 2 out of no more than 6 participants experiencing DLT at the next higher dose level. The RP2D was based on the MTD and the assessment of any relevant chronic toxicity. To obtain further confidence in the RP2D, a total maximum of 30 evaluable participants were enrolled at the MTD.|Day 21 of Cycle 1|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and were observed for ≥21 days following the first dose or the participant experienced DLT.||mg^m2|||Number
156679|NCT00322374|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|DLT: any of the following considered related to ixabepilone, epirubicin or combination occurring in Cycle 1: Absolute neutrophil count <500 cells/mm^3 for ≥7 consecutive days or febrile neutropenia of any duration;Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 w/bleeding requiring platelet transfusion;Any other drug-related Gr3/4 non-hematologic toxicity except Gr3 injection site reaction, fatigue, transient arthralgia/myalgia;Delayed recovery to Gr≤1 or baseline (except for alopecia) from toxicity related to treatment w/ ixabepilone + epirubicin delaying initiation of next cycle ≥3 wks|From Baseline to the end of Cycle 1 (Day 21)|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥1 dose of ixabepilone and epirubicin in Cycle 1, completed adequate safety evaluations, and was observed for ≥21 days following the first dose or the participant experienced DLT.||Participants|||Number
156680|NCT00322348|Secondary|Area Under the Plasma Concentration Curve (0-12 Weeks)|Area under the plasma concentration curve (0-12 weeks) derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set||ng/mL||Full Range|Geometric Mean
156681|NCT00322348|Secondary|Time to Maximum Plasma Concentration, Tmax (Hours)|Time to maximum plasma concentration, Tmax (hours), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the PK subgroup set||hours||Full Range|Geometric Mean
156682|NCT00322348|Secondary|Maximum Plasma Concentration, Cmax (ng/mL)|Maximum plasma concentration, Cmax (ng/mL), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)|Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroup|participants in the pharmacokinetic (PK) subgroup||ng/mL||Full Range|Geometric Mean
156914|NCT00320411|Secondary|4-month Progression Free Survival|The percentage of participants without progression or deaths at 4 months (16 weeks) after the start of dosing.|Baseline to Month 4 (Week 16)|ITT Population||percentage of participants|||Number
156683|NCT00322348|Secondary|Oestradiol (E2) Serum Concentrations at Week 24|A comparison of mean E2 serum concentrations at timepoint(s) post Day 1 performed using analysis of covariance (ANCOVA), with treatment group, baseline E2 serum concentrations and country as covariates. Data analysed on the log scale; log scale mean and pooled log scale standard deviation from Analysis of Covariance (ANCOVA) presented.|Blood samples for measurement of E2 concentrations collected from all patients at scheduled visits of screening, Day 1 and Weeks 12 and 24 (+/- 7 days). Week 24 data is presented|||pmol/L||Standard Deviation|Log Mean
156684|NCT00322348|Secondary|Objective Response Rate (ORR) at Week 24|Number of participants who were objective responders at Week 24 over the number of participants evaluable for response x 100. An objective responder = a participants whose best unconfirmed response is either CR (Complete Response Disappearance of all target lesions) or PR (Partial Response At least a 30% decrease in target lesions)|Response Evaluation Criteria in Solid Tumours (RECIST) tumour assessments carried out every 12 weeks from randomisation until Week 24 in those patients with measurable disease at baseline.|||Percentage of participants|||Number
156685|NCT00322348|Primary|Percentage of Participants With Progression Free Survival (PFS) at Week 24|The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.|Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).|||Percentage of participants|||Number
156686|NCT00322335|Primary|Number of Subjects With Serious Adverse Events|Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)|Analysis was performed on the Total Cohort, which included all vaccinated subjects in the booster study (NC00323050) and who came back during the follow-up.||subjects|||Number
156687|NCT00322335|Primary|Anti-PSC Concentrations|Concentrations for anti-PSC antibody were expressed as GMCs.|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
156688|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
156689|NCT00322335|Primary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)|"The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
156690|NCT00322335|Primary|Anti-PRP Concentrations|Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||µg/mL (microgram per milliliter)||95% Confidence Interval|Geometric Mean
156691|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
156692|NCT00322335|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)|The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).|18, 30, 42, 54 and 66 months after the booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
156693|NCT00322335|Primary|rSBA-MenC Titers|"Titers are expressed as Geometric Mean Titers (GMTs).~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||titer||95% Confidence Interval|Geometric Mean
156694|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128|"The cut-off value for the rSBA-MenC titers was equal to or above 1:128.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
156695|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32|"The cut-off value for the rSBA-MenC titers was equal to or above 1:32.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
156696|NCT00322335|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8|"The cut-off value for the rSBA-MenC titers was equal to or above 1:8.~0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section."|18, 30, 42, 54 and 66 months after booster dose (day 0)|Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).||subjects|||Number
156697|NCT00322231|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|Per-protocol population||Geometric mean fold rise||95% Confidence Interval|Number
156698|NCT00322231|Secondary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination|4 weeks postvaccination|Per-protocol population||gpELISA units/mL||95% Confidence Interval|Geometric Mean
156699|NCT00322231|Primary|Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event|To Day 28 postvaccination|All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo.||Participants|||Number
156700|NCT00322153|Secondary|Change From Baseline in the 19-Item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)|The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).|Baseline to week 24|The secondary efficacy analysis was based on the ITT Population. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
156701|NCT00322153|Primary|Clinician’s Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)|The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient’s global status relative to Baseline, ranging from a score of 1, indicating “marked improvement” to a score of 4, indicating “no change” to a score of 7, indicating “marked worsening.”|Week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Mean
156702|NCT00322153|Primary|Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)|The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.|Baseline to week 24|Primary efficacy analysis was based on the Intent-to-Treat (ITT) Population. The ITT Population was consisted of all patients in the Safety Population who completed at least one post-Baseline efficacy assessment in SIB or CIBIC-Plus. The last-observation-carried-forward approach was used to impute missing post-Baseline values.||Units on a scale||Standard Error|Least Squares Mean
156703|NCT00322101|Secondary|Incidence and Severity of Acute and Chronic Graft-vs-host Disease||After transplantation|||participants|||Number
156704|NCT00322101|Secondary|Incidence of Disease Progression/Relapse|Disease progression/relapse was defined by IWG criteria|After stem cell infusion to date of last follow up.|||participants|||Number
156705|NCT00322101|Secondary|Donor Cell Engraftment|Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%.|After stem cell infusion to day 28|2 patients who were randomized to receive nonmyeloablative conditioning did not undergo transplant due to relapse and withdrawal of consent||participants|||Number
156706|NCT00322101|Secondary|Non-relapse Mortality||At 100 days|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent||participants|||Number
156707|NCT00322101|Secondary|Progression-free Survival|IWG criteria was used to determine disease progression|After stem cell infusion to date of last follow up.|2 patients in the nonmyeloablative arm did not receive a transplant due to relapse and withdrawal of consent||participants|||Number
156708|NCT00322101|Primary|Overall Survival||At 2 years|2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent||participants|||Number
156709|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Standard Deviation|Mean
156710|NCT00321984|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Inter-Quartile Range|Median
156711|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.||percentage of days||Standard Deviation|Mean
156712|NCT00321984|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.||percentage of days||Inter-Quartile Range|Median
156713|NCT00321932|Secondary|Mean Change in Total Testosterone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Testosterone affects the brain, bone and muscle mass, fat distribution, the vascular system, energy levels, genital tissues, and sexual functioning.|From Time of Transplant to 12 Months Post-Transplant|||ng/dL||Standard Deviation|Mean
156714|NCT00321932|Secondary|Mean Change in Ultrasensitive Estradiol|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics.|From Time of Transplant to 12 Months Post-Transplant|||pg/ml||Standard Deviation|Mean
156715|NCT00321932|Secondary|Mean Change in Thyroid Function Test 4|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Individuals who have hyperthyroidism will have an elevated thyroxine (FT4). Low serum thyroxine can also indicate a pituitary problem.|From Time of Transplant to 12 Months Post-Transplant|||ng/dL||Standard Deviation|Mean
156716|NCT00321932|Secondary|Mean Change in Follicle-Stimulating Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Follicle-stimulating hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant|||IU/L||Standard Deviation|Mean
156717|NCT00321932|Secondary|Mean Change in Luteinizing Hormone|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. Luteinizing hormone is a hormone produced by the anterior pituitary gland.|From Time of Transplant to 12 Months Post-Transplant|||IU/L||Standard Deviation|Mean
156718|NCT00321932|Secondary|Mean Change in Urinary N-terminal Telopeptide|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. In bone physiology, the N-terminal telopeptide is a biomarker used to measure the rate of bone turnover.|From Time of Transplant to 12 Months Post-Transplant|||nM Bone Collagen Equivalents/mM creatini||Standard Deviation|Mean
156719|NCT00321932|Secondary|Mean Change in Serum Bone Specific Alkaline Phosphate|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. The decrease in serum bone-specific alkaline phosphatase predicts bone mineral density response to hormone replacement therapy in early postmenopausal women.|From Time of Transplant to 12 Months Post-Transplant|||U/L||Standard Deviation|Mean
156720|NCT00321932|Secondary|Mean Change in Serum Osteocalcin|Change in bone resorption markers of bone metabolism measured at baseline and 12 months post transplant for all enrolled patients. As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process.|From Time of Transplant to 12 Months Post-Transplant|||ng/ml||Standard Deviation|Mean
156721|NCT00321932|Primary|Mean Change in Bone Mineral Density|"Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months.~This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline."|From Time of Transplant to 12 Months Post-Transplant|||percent||Standard Deviation|Mean
156722|NCT00321919|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Values above and below the given reference range were determined as High or Low range values of the laboratory parameter. Roche’s standard reference ranges for laboratory test parameters were used for the analysis. The laboratory parameters with marked abnormality are platelets (reference range is 150-350 10^9 cells/liter [L]), creatinine (reference range is 0-133 micromole per liter), albumin (reference range is 35.0-55 g/L), phosphate (reference range is 0.84-1.45 millimole per liter [mmol /L]) and potassium (reference range is 3.4-4.8 mmol /L).|Baseline, every 3 months up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment. The ‘’n” represents the number of participants assessed for each laboratory parameter.||participants|||Number
156723|NCT00321919|Secondary|Number of Participants on Blood Pressure/Anti-Hypertensive Treatment According to Class Of Drugs|Anti-hypertensive is defined as class of drugs that are used to treat hypertension. Numbers (No.) of participants treated with at least one hypertensive medication/Treatment (Tt) according to class of drugs were reported.|Up to 4 years|The safety analysis population included all participants who were randomized and who had received a safety follow-up whether or not they had received epoetin beta treatment.||participants|||Number
156724|NCT00321919|Secondary|Mean Change From Baseline in the Scores of Each of The Eight Health Scales of Quality of Life Based on Short Form-36 (SF-36) Questionnaire|The Quality of life was assessed on the basis of a change from baseline in the scores of each of the eight health scales in the SF-36 questionnaire. The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well-being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health (GH), vitality, mental health. The score for a section is an average of the individual question scores, which are scaled from 0 (worst level of functioning) to 100 (100=best level of functioning). The least squares mean (LSM) change from baseline was determined by Analysis of covariance (ANCOVA) model and presented for each of the eight health scale.|Baseline, Year 1, and Year 2|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||units on a scale||Standard Error|Least Squares Mean
156725|NCT00321919|Secondary|Mean Values of Body Surface Area|The body surface area (BSA) was determined by Echocardiogram. Absolute mean values of Echocardiography (ECHO) Parameter: Body surface area (BSA) at Baseline, Year 1, Year 2, Year 3 and Year 4 were calculated and presented.|Baseline, Year 1, Year 2, Year 3, and Year 4.|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for Body surface area through echocardiogram at Baseline, Year 1, Year 2, Year 3 and Year 4.||Square meter||Standard Deviation|Mean
156726|NCT00321919|Secondary|Mean Values of Echocardiography Parameters|Mean values of Echocardiography (ECHO) Parameters: Left Ventricular End Diastolic Diameter (LVEDD), Left Ventricular Posterior Wall Thickness (LVPWT), IV Septal Wall Thickness (IVSWT), LV End Systolic Diameter (LVESD), LV Relative wall thickness (LVRWT) at Baseline, Year 1, Year 2, Year 3 and Year 4 were presented.|Baseline, Year 1, Year 2, Year 3, and Year 4|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for each echocardiography parameter at Baseline, Year 1, Year 2, Year 3 and Year 4.||centimeters||Standard Deviation|Mean
156727|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Volume (LV Volume )|Left Ventricular Volume is the estimated of left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) determined by Echocardiogram. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LV Volume at Baseline, Week 12, Week 24, Week 36 and Week 48.||milliliters per meter square||Standard Deviation|Mean
156728|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) and Fractional Myocardial Shortening (FS)|LVEF is a marker of left ventricular systolic function and determined by echocardiogram. It is expressed as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage. FS is used as an estimate of myocardial contractility and determined by echocardiogram and measures as a percentage. The change for LVEF and FS was calculated as Week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVEF and FS at Baseline, Week 12, Week 24, Week 36, and Week 48.||percentage||Standard Deviation|Mean
156729|NCT00321919|Secondary|Mean Change From Baseline in Left Ventricular Mass Index (LVMI)|LVMI is determined by echocardiogram. LVMI indexed to body surface area (gram/square meter) estimated by LV cavity dimension and wall thickness at end-diastole. The change was calculated as week value minus baseline value.|Baseline, Week 12, Week 24, Week 36, and Week 48|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for LVMI at Baseline, Week 12, Week 24, Week 36, and Week 48.||gram/square meter||Standard Deviation|Mean
156730|NCT00321919|Secondary|Duration of Hospitalization for Cardiovascular Events|The duration of hospitalization was the total number of days that a participant was hospitalized due to cardiovascular events. Participants with no hospitalization were excluded from analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. Data for the participants present at the time of assessment was used for analysis.||days||Standard Deviation|Mean
156731|NCT00321919|Secondary|Median Time to First Hospitalization Due to Cardiovascular Events|Time to first hospitalization due to cardiovascular events is defined as the time determined between randomization and first hospitalization due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
156732|NCT00321919|Secondary|Total Number of Cardiovascular Intervention|Cardiovascular intervention was defined by a clinical review of all concomitant treatments. The cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation. The total number of cardiovascular intervention was determined and presented by each cohort.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||number of cardiovascular intervention|||Number
156926|NCT00320385|Secondary|Overall Survival (OS)|OS was defined as the time from randomization until death due to any cause. For participants who did not die, OS was censored at the time of last contact.|Baseline to death or 30 days after last dose for the last participant (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.||weeks||95% Confidence Interval|Median
156733|NCT00321919|Secondary|Median Time to First Cardiovascular Intervention|Time to first cardiovascular intervention is the time between randomization and first intervention determined for all cardiovascular interventions after randomization. Cardiovascular interventions considered were: angioplasty with or without stents/atherectomy, coronary artery bypass surgery, cardioverter defibrillator (CD) cardioversion/defibrillation, temporary pacemaker, permanent pacemaker and implantable cardioverter defibrillator (ICD) implantation.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
156734|NCT00321919|Secondary|Number of Participants Experiencing Worsening of New York Heart Association (NYHA) Class (CL) of Chronic Heart Failure From Baseline (BL)|The NYHA functional classification assesses the severity of symptoms of chronic heart failure and is comprised of four classes. Class I is defined as no limitation of physical activity, Class II is defined as slight limitation of physical activity, Class III is defined as marked limitation of physical activity, and Class IV is defined as unable to carry on any physical activity without discomfort. Shifts of participants from CL 0, CL I, CL II, CL III, CL IV at Baseline (Day 1) to CL 0, CL I, CL II, CL III, CL IV during the study period was determined and presented.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received. The “n” represents the number of participants assessed for shifts in NYHA class from baseline.||participants|||Number
156735|NCT00321919|Secondary|Number of Participants Who Died Due to All Causes|Number of participants who died due to all causes are presented in table below.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||participants|||Number
156736|NCT00321919|Secondary|Median Time to Death Due to All Causes|Time to death due to all causes is the time determined between randomization and death due to all causes.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
156737|NCT00321919|Secondary|Number of Participants Who Died Due to Cardiovascular Events|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||participants|||Number
156738|NCT00321919|Secondary|Median Time to Death Due to Cardiovascular Events|Time to death due to cardiovascular events is the time determined between randomization and death due to cardiovascular events.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
156739|NCT00321919|Primary|Median Time to First Cardiovascular Event|The cardiovascular event was defined as any of the following: angina pectoris leading to hospitalization for at least 24 hours or prolongation of hospitalization, acute heart failure, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, sudden death, transient cerebral ischemic attack (TIA), peripheral vascular disease (amputation, necrosis), cardiac arrhythmias leading to hospitalization for at least 24 hours or prolongation of hospitalization. The time to occurrence of a cardiovascular event was determined as the time from randomization until any of the above listed events whichever occurred first. The first event per participant was used for the analysis. Only events confirmed by the Endpoint Committee were considered for analysis.|Up to 4 years|The ITT population included all participants randomized according to their randomized treatment group, regardless of the treatment actually received.||days||Inter-Quartile Range|Median
156740|NCT00321906|Secondary|Overall Survival at 36 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 36 months.|36 mos|||percentage of participants|||Number
156741|NCT00321906|Secondary|Overall Survival at 24 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 24 months.|24 mos|||percentage of participants|||Number
156742|NCT00321906|Secondary|Overall Survival at 12 Months|Kaplan-Meier estimate of proportion of patients that survived to (i.e., had not died by) 12 months.|12 mos|||percentage of participants|||Number
156743|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 36 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 36 months.|36 mos|||percentage of participants|||Number
156744|NCT00321906|Secondary|Bronchiolitis Obliterans Syndrome (BOS) at 24 Months|Kaplan-Meier estimate of proportion of patients that had not experienced BOS by 24 months.|24 mos|||percentage of participants|||Number
156745|NCT00321906|Secondary|Severity of Acute Rejection at 12 Months|"Raw proportion of patients that experienced rejection at or above grade A2 by 12 months.~Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos|||percentage of participants|||Number
156746|NCT00321906|Secondary|Acute Rejection-free Survival at 12 Months|"Kaplan-Meier estimate of proportion of patients that had not experienced acute rejection by 12 months. Acute rejection is defined as rejection at any of the following grades.~Grade A0 - None With/Without Grade A1 - Minimal Grade A2 - Mild Grade A3 - Moderate"|12 mos|The analysis population included patients who underwent at least one transbronchial biopsy.||percentage of participants|||Number
156747|NCT00321906|Primary|Acute Rejection Rate at 12 Months|Raw proportion of patients that experienced acute rejection at or before 12 months.|12mos|||percentage of participants|||Number
156748|NCT00321893|Primary|Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months|Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the follow up Computed Tomography (CT) scan.||participants|||Number
156749|NCT00321893|Primary|Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months|For single nodules >5 mm, clinical meaningful shrinkage of 30% or > longest diameter (LD) considered treatment success after 1 year treatment; for <5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target & non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% > sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.|12 Months|Per person analysis. Excluded from analysis were three participants in Arm I: Budesonide and one participant in Arm II: Placebo who refused the Computed Tomography (CT) scan.||participants|||Number
156750|NCT00321893|Primary|Size of CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years|Baseline assessment|Per person analysis. Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.||lung nodules|Participants||Number
156751|NCT00321893|Primary|Number CT- Detected Lung Nodules by Participant|Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.|Baseline assessment|Per person analysis in overall randomized study (202 participants) using identification (baseline) CT.||lung nodules|Participants||Number
156752|NCT00321854|Secondary|Clinically Significant Abnormalities in Vital Signs||Baseline and Month 15|Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX.||percentage of participants|||Number
156753|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates||Baseline and Month 15|Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX.||percentage of participants|||Number
156754|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes||Baseline and Month 15|Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX||percentage of participants|||Number
156755|NCT00321854|Secondary|Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes||Baseline and Month 15|Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX||percentage of participants|||Number
156756|NCT00321854|Secondary|Percentage Change From Baseline in the Striatum Uptake at Month 15|The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).|Baseline and Month 15|The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.||Percentage change||Standard Error|Least Squares Mean
156757|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156758|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156759|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156760|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156761|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156762|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156763|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156764|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156765|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156766|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156767|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156768|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 12|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156769|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156770|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
156771|NCT00321854|Secondary|Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1|The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.|Month 1|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.||Participants|||Number
157024|NCT00319553|Primary|Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Geometric mean concentration of antibody to the pertussis antigens were analyzed in the per-protocol population||EU/mL||95% Confidence Interval|Geometric Mean
156772|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
156773|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15|The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
156774|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
156775|NCT00321854|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15|The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
156776|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Inter-Quartile Range|Median
156777|NCT00321854|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial.||Units on a scale||Inter-Quartile Range|Median
156778|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156779|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156780|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156781|NCT00321854|Secondary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data.||Units on a scale||Standard Error|Least Squares Mean
156782|NCT00321854|Secondary|Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15|The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data.||Participants|||Number
156783|NCT00321854|Secondary|Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.|Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data.||Participants|||Number
156784|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156785|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156786|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156787|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156788|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15|The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
156789|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156790|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156791|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156792|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156793|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15|The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
156794|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156795|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156796|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156797|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15|The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
157025|NCT00319553|Primary|Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Diphtheria antitoxin concentrations were analyzed in the per-protocol population||Percentage of Participants|||Number
156799|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156800|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156801|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156802|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156803|NCT00321854|Secondary|Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15|The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
156804|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 3|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156805|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 6|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156806|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 9|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156807|NCT00321854|Secondary|Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.||Units on a scale||Standard Error|Least Squares Mean
156808|NCT00321854|Primary|Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15|The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)|Baseline and Month 15|The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial||Units on a scale||Standard Error|Least Squares Mean
156809|NCT00321828|Secondary|Overall Survival as Measured by Death From Any Cause||Time from start of study through year 5||||||
156810|NCT00321828|Secondary|Serious Adverse Events (Grades 3, 4, and 5) as Defined by CTCAE v3.0||Time from start of study through year 5||||||
156811|NCT00321828|Secondary|Local Complications as Assessed by Other Events Related to the Intact Primary Tumor Which Require Hospitalization But Not Surgery||Time from start of study through year 5||||||
156812|NCT00321828|Secondary|Local Complications as Assessed by Fistula Formation (Self-draining Enterocutaneous Fistula and Intra-abdominal Abscess Requiring Percutaneous Drainage) Not Requiring Surgery||Time from start of study through year 5||||||
156813|NCT00321828|Secondary|Local Complications as Assessed by Gastrointestinal Bleeding Requiring Transfusion But Not Requiring Surgery||Time from start of study through year 5||||||
156814|NCT00321828|Secondary|Local Complications as Assessed by Colonic Obstruction Requiring Hospitalization (But Not Surgery) for Medical Management, Stent Placement, Laser Treatment, or Fulguration||Time from start of study through year 5||||||
157026|NCT00319553|Primary|Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.||Day 0 and 28 days post-vaccination|Tetanus antitoxin concentrations were analyzed in the per-protocol population.||Percentage of Participants|||Number
156815|NCT00321828|Primary|Major Morbidity Related to the Intact Primary Tumor|Cumulative incidence was used to compute percent probability of morbidity. Cumulative incidence at time t measures the probability of a participant having an event (i.e., Colonic bleeding, perforation, bowel obstruction, or fistula formation requiring surgery or resulting in patient death) over the given duration, t. It involves computing the probability of an event at any observed time (i.e., the number of new cases during a period divided by the number of subjects at risk) and multiplying these successive probabilities by any early computed probability to get the final estimate.|24 months|||probability of major morbidity (%)||95% Confidence Interval|Number
156816|NCT00321269|Secondary|Health-Related Quality of Life|Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.|Measured at week 1, week 8|Older Veterans with Congestive Heart Failure||units on a scale||Standard Deviation|Mean
156817|NCT00321269|Primary|Beck Depression Inventory II|Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.|Depression and psychological health will be assessed at week 1, week 8|Older Veterans with Heart Failure||units on a scale||Standard Deviation|Mean
156818|NCT00320801|Primary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).|Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)|The safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 safety assessment after the initial dose of BTDS in the study.||Participants|||Number
156819|NCT00320788|Post-Hoc|Mean Change in BCVA as Measured by ETDRS From Baseline at Week 16|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at Week 16|FAS used for analysis, LOCF||letters read||Standard Deviation|Mean
156820|NCT00320788|Post-Hoc|Mean Change of CR/LT From Baseline at Week 16|CR/LT measured in micrometers (µm); lower individual values represent better outcomes|Baseline and at Week 16|FAS used for analysis, LOCF||µm||Standard Deviation|Mean
156821|NCT00320788|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|At Week 12|FAS used for analysis, LOCF||percentage of participants|||Number
156822|NCT00320788|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12|Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning|Baseline and at week 12|FAS used for analysis, LOCF||letters read||Standard Deviation|Mean
156823|NCT00320788|Secondary|Mean Percent Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome|Baseline and at Week 12|FAS used for analysis, LOCF||percent change||Standard Deviation|Mean
156824|NCT00320788|Primary|Mean Change of CR/LT From Baseline at Week 12|CR/LT measured in micrometers (µm); lower individual values represent better outcomes.|Baseline and at Week 12|Full Analysis Set (FAS) used for analysis, Last Observation Carried Forward (LOCF)||μm||Standard Deviation|Mean
156825|NCT00320749|Secondary|Therapeutic Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks, up to 24 weeks|3 patients were non-evaluable for response or progression free survival as they withdrew consent after cycle 1 of therapy.||percent of patients|||Number
156826|NCT00320749|Secondary|Common Toxicities|The NCI Common Terminology Criteria for Adverse Events version 3.0 was used for adverse event reporting and toxicity grading.|Weekly up to 24 weeks|grade 3 and grade 4 toxicities according to National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0||percent of patients|||Number
156827|NCT00320749|Primary|Maximum Tolerated Dose (MTD)|MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).|Weekly up to 24 weeks|||mg/m^2|||Number
156828|NCT00320710|Secondary|Skeletal Morbidity Rate|An SMR for a patient was defined as the “number of occurrences” of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the “time at risk” in years. The “number of occurrences” and the “time at risk” were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as “at risk”. For example, if a patient had 1 SRE during the study, the “time at risk” was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as “time at risk”. This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).|52 weeks|This population included all participants who were in the zoledronic acid q 4 weeks and zoledronic acid q 12 weeks treatment groups.||Number of events per year||Standard Deviation|Mean
156829|NCT00320710|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase|Serum samples were collected to obtain bone specific alkaline phosphatase values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.||mcg/L||Standard Deviation|Mean
156830|NCT00320710|Secondary|Change From Baseline in Urinary N-telopeptide / Creatinine Ratio|Urine samples were collected to obtain n-telopeptide and creatinine values.|baseline, 48 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 48 values.||ratio||Standard Deviation|Mean
157074|NCT00318929|Secondary|Patient's Compliance With Once a Day Dosing.|Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.|24 weeks||||||
157075|NCT00318929|Primary|Effectiveness of Medication as Measured by Participation Through the End of the Trial.|Number of participants completing the trial|24 weeks|||participants|||Number
156831|NCT00320710|Secondary|Change From Baseline in Mean Analgesic Score|The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.||score||Standard Deviation|Mean
156832|NCT00320710|Secondary|Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score|Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.|baseline, 52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups and had both baseline and week 52 values.||scores on a scale||Standard Deviation|Mean
156833|NCT00320710|Secondary|Time to First Individual Type of SRE|Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.||Weeks||95% Confidence Interval|Median
156834|NCT00320710|Secondary|Time to First SRE|An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.||Days||95% Confidence Interval|Median
156835|NCT00320710|Primary|Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)|An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.|52 weeks|The population included participants who were in the zoledronic acid q4 weeks and zoledronic acid q12 weeks treatment groups.||Percentage of participants|||Number
156836|NCT00320671|Primary|Percentage of Participants That Responded to Treatment|Brief Psychiatric Rating Scale-Anchored (BPRS-A) 4 items on this scale were examined to determine subjects responder status: Items 4. Conceptual Disorganization 8. Grandiosity 12. Hallucinations and 15. Unusual Thought Content. Scores range from-7 (not assessed) to 7 (very severe) Subjects with scores of 3 or less on all 4 items for 2 consecutive visits are deemed responders, subjects with 4 or greater and any of the aforementioned items for 2 consecutive study visits are non responders. Additionally, the subjects response on the Clinical Global Impressions Scale. A Clinical Global Improvement CGI) rating of much or very much improved on 2 consecutive ratings were deemed a responder. Percentages and confidence intervals were used to report response outcome. Response status was assessed throughout the duration of the study; a participant can be deemed a responder any time between weeks 1-week 12. The possible range for this outcome is a score of 4 to 28|this outcome was assessed throughout the study.|BPRS-A and CGI scores for each group were analysed to determine the percentage of participants that responded to apriprazole and risperidone. The threshold for significance was p=.05||percentage of response||95% Confidence Interval|Number
156837|NCT00320606|Secondary|Changes in Renal Function, Blood Pressure, Cholesterol Level, and Glucose Control||throughout trial||02/2018||||
156838|NCT00320606|Secondary|Incidence of Adverse Events||throughout trial||02/2018||||
156839|NCT00320606|Secondary|Distribution of Histologic Severity Among Rejection Episodes||Immunosuppression to rejection||02/2018||||
156840|NCT00320606|Secondary|Time From Start of Immunosuppression to the First Episode of Acute Rejection or to Diagnosis of Chronic Rejection||Immunosuppression to first acute rejection or diagnosis of chronic rejection||02/2018||||
156841|NCT00320606|Primary|Proportion of Patients Who Suffer Graft Loss or Die Following Initiation of Immunosuppression Withdrawal||1 year||02/2018||||
156842|NCT00320606|Primary|Proportion of Subjects Successfully Withdrawn From Immunosuppression|Subjects were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function|1 year after completion of immunosuppression withdrawal|Intent-to-Treat||Participants|||Number
156843|NCT00320593|Secondary|Excellent Spectacle Compliance|Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often.|Baseline to 3 years|The analysis followed the intent-to-treat principle. Two patients had no compliance data because they had no follow-up visits (one single vision lenses, and one progressive-addition lenses).||percent of participants|||Number
156844|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 2 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 2 years|The analysis followed the intent-to-treat principle||diopters||Standard Deviation|Mean
156927|NCT00320385|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.|Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)|Intent-to-Treat (ITT) Population: all randomized participants irrespective of whether or not they actually received study treatment. Only participants with progesterone receptor status were considered for evaluation.||weeks||95% Confidence Interval|Median
156845|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 1 year, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 1 year|The analysis followed the intent-to-treat principle.||diopters||Standard Deviation|Mean
156846|NCT00320593|Secondary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.||diopters||Standard Deviation|Mean
156847|NCT00320593|Secondary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.||participants|||Number
156848|NCT00320593|Primary|Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|3 years|All analyses followed the intent-to-treat principle. The Monte Carlo Markov Chain (MCMC) method of multiple imputation was used to impute data for subjects who did not complete the 3-year visit.||diopters||Standard Deviation|Mean
156849|NCT00320593|Secondary|Mean Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.||diopters||Standard Deviation|Mean
156850|NCT00320593|Primary|Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.|Baseline to 3 years|The analysis followed the intent-to-treat principle.||participants|||Number
156851|NCT00320593|Secondary|Distribution of Spherical Equivalent Refractive Error at 3 Years|Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.|3 years|The analysis followed the intent-to-treat principle.||participants|||Number
156852|NCT00320541|Secondary|Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy|The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
156853|NCT00320541|Secondary|Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy|The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
156854|NCT00320541|Secondary|Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy|The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
156975|NCT00320112|Secondary|Number of Participants With Insulin Starts at 6 Months|the number of insulin starts at 6 months from baseline.|6 months (baseline to 6 months follow-up)|medical charts were reviewed to obtain this information and all participant charts were reviewed||participants|||Number
156855|NCT00320541|Secondary|Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy|The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
156856|NCT00320541|Secondary|Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy|The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
156857|NCT00320541|Secondary|Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy|The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
156858|NCT00320541|Secondary|Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.|Baseline through 30 days post therapy follow-up (up to 35 months)|Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment||units on a scale||Standard Deviation|Mean
156859|NCT00320541|Secondary|Overall Survival|Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.|baseline to death from any cause (up to 35 months)|Intent-To-Treat (ITT) population=all randomized participants, eligible & ineligible. Number of participants with events: PB=35; PB+G=34. Censored participants: PB=59;PB+G=59.||months||Full Range|Median
156860|NCT00320541|Secondary|Progression-free Survival (PFS)|PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.|baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)|ITT population=all randomized participants, eligible & ineligible. Participants with events: PB=74; PB+G=72. Censored participants: PB=20 PB+G=21.||months||Full Range|Median
156861|NCT00320541|Primary|Overall Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).|baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)|Per-protocol population included intent-to-treat participants who met the following criteria: histological or cytological breast cancer diagnosis; baseline presence of measurable disease per RECIST; at least 1 dose of study drug; no current systemic anti-tumor therapy except protocol-specified therapy. One PB+G participant did not qualify.||proportion of responders||95% Confidence Interval|Mean
156862|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
156863|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)|The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).|Baseline, 12 Weeks|Number of child patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||Standard Deviation|Mean
156875|NCT00320515|Primary|Objective Best Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug. One participant was excluded from analysis because of no measurable disease at baseline.||participants|||Number
156864|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)|Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).|Baseline, 12 Weeks|Number of adolescent patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||Standard Deviation|Mean
156865|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale|Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
156866|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
156867|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)|The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
156868|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||T-Score||95% Confidence Interval|Mean
156869|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
156870|NCT00320528|Secondary|Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||units on a scale||95% Confidence Interval|Mean
156871|NCT00320528|Primary|Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.|Baseline, 12 Weeks|Number of patients with baseline and at least one nonmissing post-baseline measurement.||T-Score||95% Confidence Interval|Mean
156872|NCT00320515|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measurable disease at baseline. Thirty-five participants were censored.||months||95% Confidence Interval|Median
156873|NCT00320515|Secondary|Progression Free Survival|The period from study entry until disease progression or death on study, whichever occurred first.|baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug and had measureable disease at baseline. Twenty-six participants were censored.||months||95% Confidence Interval|Median
156874|NCT00320515|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants who received at least one dose of study drug, had measureable disease at baseline, and had confirmed complete or partial responses. There were 16 patients qualified for the analysis of duration of response. Twelve participants were censored.||months||95% Confidence Interval|Median
156877|NCT00320489|Secondary|Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin|Treatment-emergent (TE) high ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to >=3 times the ULN at endpoint. TE high AST is defined as a baseline value of <5 times the ULN to >=5 times the ULN at endpoint. TE high total bilirubin is defined as a baseline value of <2 times the ULN to >=2 times the ULN at endpoint. Hy's Rule is defined as ALT >=3 times the ULN and total bilirubin >=2 times the ULN.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
156878|NCT00320489|Secondary|Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks|The prolactin reference Range is: Female: 2.0 - 29.0 nanograms per milliliter (ng/mL); Male: 2.0 - 20.0 ng/mL. A treatment-emergent abnormally high value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
156879|NCT00320489|Secondary|Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides|Normal to high fasting glucose = <100 milligrams per deciliter (mg/dL) baseline; >=126 mg/dL any time post baseline (or endpoint). Normal to high fasting total cholesterol =<200 mg/dL baseline; >=240 mg/dL any time post baseline or endpoint. Fasting triglycerides <150 mg/dL baseline; >=200 mg/dL and <500 mg/dL any time post baseline or endpoint.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
156880|NCT00320489|Secondary|Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks|PCS weight gain is defined as a >=7% increase in weight from baseline at 104 weeks.|Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
156881|NCT00320489|Secondary|Change From Baseline in Weight at 104 Weeks||Baseline, 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Kilograms||Standard Deviation|Mean
156882|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization|Number of outpatient surgeries during the study, post-baseline through 104 weeks.|Baseline through 104 Weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Surgeries||Standard Deviation|Mean
156883|NCT00320489|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks|BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. For this study, the BPRS total score was derived from 18 PANSS questions. To calculate the score, the score of the 18 questions was added then 18 was subtracted from the total. As an example, if a subject had a score=1 (absent) on all 18 items, the resulting total=zero. Responses range from 0 (absent) to 6 (extremely severe); the Total Score range is 0-108.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a scale||Standard Error|Least Squares Mean
156884|NCT00320489|Secondary|Number of Participants Experiencing Relapse|Relapse is defined as any one of the following: 1) hospitalization for symptoms related to schizophrenia; 2) an increase of 25% from baseline in the total score on the PANSS (if the baseline score was >40), or an increase of 10 points (if baseline score was <=40) and >=1-point increase from baseline score on the CGI-S score, provided that the increase results in a CGI-S score >=4; 3) deliberate self-injury or injury to others that is deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
156885|NCT00320489|Secondary|Median Time to Relapse|Relapse is defined as any 1 of the following: 1) hospitalization for symptoms related to schizophrenia; 2) increase of 25% from baseline in PANSS total score (range:30-210) (if baseline score was >40) or increase of 10 points (if baseline score was ≤40), and ≥1-point increase from baseline on CGI-S score (range:1-7), provided that increase results in CGI-S ≥4; 3) deliberate self-injury or injury to others deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis. On PANSS and CGI-S higher scores indicate greater illness.|Baseline to time of relapse (up to 104 weeks)|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Inter-Quartile Range|Median
156976|NCT00320112|Secondary|Change in Diastolic Blood Pressure|change in diastolic blood pressure was measured at 6 months|6 months from baseline|As noted earlier, for physiologic measures only 113 of the 125 peer support participants were able to provide 6 month follow-up data and 103 of 119 nurse management group provided 6 month follow-up data.||mmHg||Standard Deviation|Mean
156886|NCT00320489|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156887|NCT00320489|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156888|NCT00320489|Secondary|Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)|Number of participants who discontinued study participation for any reason (excluding sponsor decision).|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Participants|||Number
156889|NCT00320489|Secondary|Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks|Self-rated scale which measures patient's subjective feelings about taking medications. Each of 10 items is rated as true or false. For items 1, 3, 4, 6, 7, 9, and 10, true is scored as 1; false is scored as 0. For items 2, 5, and 8, true is scored as 0; false is scored as 1. Possible total scores range from 0-10. A subject who answers all 10 questions false will have a score of 3; a subject who answers all 10 questions true will have a score of 7. For 7 out of 10 questions, false is represented by 0, the other 3 questions false is represented by a value=1.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156890|NCT00320489|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items)|Self-rated scale which measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1-'very dissatisfied' to 5-'very satisfied'), preference comparing current study medication versus previous medications (scored from 1-'much prefer previous medication' to 5-'much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1-'much less side effects' to 5-'much more side effects'). Range of possible scores is 3-15.|104 weeks|All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156891|NCT00320489|Secondary|Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks|Interviewer-rated 49-item scale used to assess 4 functional domains in patients with schizophrenia : 1) living situation, 2) instrumental activities of daily living, 3) productive activities and role functioning, and 4) social/recreational functioning. Possible responses and scoring vary by item and by domain, with higher scores representing better functioning. Range of possible scores is 1-100. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156892|NCT00320489|Secondary|Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks|Self-rated scale assessing patients' level of alliance with their therapist, including agreement on goals, tasks, and emotional bond. Each of 12 items is rated from 1 ('never') to 7 ('always'), with higher scores indicating greater alliance. Total Scores range from 12-84. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156893|NCT00320489|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks|Interviewer-rated scale that assesses patients' awareness of and insight into their illness. SUMD can either be based on 4 items or 5 items. Items 1 through 4 are rated from 1 (aware) to 5 (unaware); item 5 assesses correct attribution of symptoms to a mental disorder and is rated from 1 (symptoms correctly attributed) to 5 (symptoms incorrectly attributed). Total Scores for Items (1-4) range from 4 to 20 and Total Scores for Items (1-5) range from 5 to 25. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
157076|NCT00318812|Secondary|Transferrin Saturation|Comparison of Transferrin Saturation between the Groups|6 Months|||percentage of bound iron sites||Inter-Quartile Range|Median
156894|NCT00320489|Secondary|Number of Hospitalization Days|Mean - calculated based on total number of hospitalization days per patient within reporting interval.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Standard Deviation|Mean
156895|NCT00320489|Secondary|Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study|Number of days of unpaid care, number of days of workdays missed, number of days of paid care per week during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Standard Deviation|Mean
156896|NCT00320489|Secondary|Resource Utilization: Number of Outpatient Physician Visits During the Study|Number of outpatient physician visits during the study, post-baseline through 104 weeks.|Baseline through 104 weeks|All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Outpatient physician visits||Standard Deviation|Mean
156897|NCT00320489|Secondary|Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks|"Self-rated scale completed by patient's caregiver which measures level of burden placed on the caregiver by caring for the patient. Each of 19 items is rated on a scale from 0 (no impact) to 3 (high negative impact). Total Score range is 0-57. If any of the 19 questions were answered not applicable, then a Total Score of 9 was entered. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline."|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156898|NCT00320489|Secondary|Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks|Generic, multidimensional, health-related, quality-of-life instrument. Overall health status is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156899|NCT00320489|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores|SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains. Domains and scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. There are 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.|Baseline, 104 weeks|All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.||Units on a Scale||Standard Error|Least Squares Mean
156900|NCT00320489|Secondary|Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks|Interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning). Total score range is 0-126. Least Squares Mean (LS Mean) values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.|Baseline, 104 weeks|All data were analyzed on ITT basis. ITT analysis: analysis of all randomized patients allocated to the randomized treatment even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on mixed-model repeated measures (MMRM) methodology.||Units on a Scale||Standard Error|Least Squares Mean
156901|NCT00320489|Primary|Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)||Baseline up to 104 weeks|All data was analyzed on an intent-to-treat (ITT) basis. An ITT analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Days||Inter-Quartile Range|Median
156902|NCT00320411|Secondary|Mean Terminal Deoxynucleotidyl Transferase Biotin-dUTP Nick End Labeling (TUNEL) H Score for All Participants|Intra-tumoral expression levels of TUNEL, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156995|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: III|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with Stage III disease||percentage of participants|||Number
156903|NCT00320411|Secondary|Mean Survivin H Score for All Participants|Intra-tumoral expression levels of Survivin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156904|NCT00320411|Secondary|Mean Insulin-like Growth Factor 1 Receptor (IGF1R) H Score for All Participants|Intra-tumoral expression levels of IGF1R, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156905|NCT00320411|Secondary|Mean Heregulin H Score for All Participants|Intra-tumoral expression levels of Heregulin, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156906|NCT00320411|Secondary|Mean Phosphorylated Extracellular Signal-regulated Kinase (p-ERK) H Score for All Participants|Intra-tumoral expression levels of ERK, a tumor tissue biomarker, were measured.using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156907|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 4 (ErbB4) H Score for All Participants|Intra-tumoral expression levels of ErbB4, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156908|NCT00320411|Secondary|Mean Epidermal Growth Factor Receptor 3 (ErbB3) H Score for All Participants|Intra-tumoral expression levels of ErbB3, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156909|NCT00320411|Secondary|Mean Bcl-2 H Score for All Participants|Intra-tumoral expression levels of Bcl-2, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156910|NCT00320411|Secondary|Mean p-BAD H Score for All Participants|Intra-tumoral expression levels of BAD, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation||units on a scale||Standard Deviation|Mean
156911|NCT00320411|Secondary|Mean Phosphorylated 58 kDa Serine/Threonine Protein Kinase (p-AKT) H Score for All Participants|Intra-tumoral expression levels of AKT, a tumor tissue biomarker, were measured using immunohistochemistry methods that incorporated both intensity and distribution of staining. A value designated the H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Tumor samples taken at baseline|Participants who provided enough tumor samples for this evaluation.||units on a scale||Standard Deviation|Mean
156912|NCT00320411|Secondary|Overall Survival|Overall survival was measured as the time between the start of dosing until death, regardless of cause.|Start of dosing to death; baseline and then followed every 4 weeks until death while on treatment. If alive at time of treatment termination, then followed every 12 weeks until death.|ITT Population||weeks||Inter-Quartile Range|Median
156915|NCT00320411|Secondary|Time to Response|Time to response was defined as the time from the start of treatment until first documented evidence of partial or complete tumor response (whichever status is recorded first).|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse event, then followed every 12 weeks until DP or death.|Participants in the ITT Population achieving a partial or complete response||Days||Full Range|Median
156916|NCT00320411|Secondary|Clinical Benefit|Clinical benefit was defined as the percentage of participants achieving complete response, partial response, and stable disease for more than 24 weeks.|Time at which all participants had been followed for at least 24 weeks; baseline and then followed every 4 weeks until disease progression (DP) or death. If treatment was terminated due to adverse events, then followed every 12 weeks until DP or death.|ITT Population||percentage of participants|||Number
156917|NCT00320411|Secondary|Time to Progression|Time to progression was defined as the time from the start of treatment until disease progression or death. Disease progression is defined as a 20% increase in the sum of the longest diameter of target lesions.|Baseline to disease progression or death; baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression or death.|ITT Population||weeks||Inter-Quartile Range|Median
156918|NCT00320411|Secondary|Duration of Response|Duration of response is defined as the time between the point at which efficacy was noted until disease progression or death due to breast cancer.|First noted efficacy to disease progression; baseline and followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Participants who achieved defined efficacy||weeks||Inter-Quartile Range|Median
156919|NCT00320411|Primary|Overall Tumor Response|Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.|Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.|Intent-to-Treat (ITT) Population: all participants who had been registered and received at least one dose of the investigational product||participants|||Number
156920|NCT00320385|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144.|Baseline, Week 4, Week 12, Week 16, Week 24, and conclusion or withdrawal from study (up to Week 108)|Safety Population: all randomized participants who received >=1 dose of investigational product. The Safety Population was based on the actual treatment received, if this differed from that to which the participant was randomized. Only participants whose overall item response rate was greater than 80% for the FACT-B total score were considered (n).||scores on a scale||Standard Deviation|Mean
156921|NCT00320385|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the date of randomization and the earlier of the date of disease progression or death due to breast cancer. Because this outcome measure was confounded by death due to other causes and was similar to PFS, it was not analyzed.|Baseline to disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population|||||
156922|NCT00320385|Secondary|Duration of Response (DR)|DR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the first documented evidence of CR or PR until the first documented sign of disease progression or death. Because of the low number of participants experiencing a confirmed response in both treatment arms, analysis for this outcome measure was not performed.|Time from first documented evidence of CR or PR until the first documented sign of disease progression or death or 30 days after last dose (up to 216 weeks)|ITT Population|||||
156923|NCT00320385|Secondary|Time to Response (TTR)|TTR was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). TTR could not be analyzed because too few participants experienced a confirmed CR or PR.|Baseline until first documented evidence of CR or PR or 30 days after last dose (up to 216 weeks)|ITT Population|||||
156924|NCT00320385|Secondary|Clinical Benefit Response (CBR)|CBR: percentage of participants with confirmed CR or PR or stable disease (SD) for at least 24 weeks according to RECIST criteria. CR: disappearance of all lesions (target and/or non-target). PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference baseline sum LD, with non-target lesions not increased or absent. SD: neither had sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) in target lesions, taking as reference the smallest sum LD since treatment started; persistence of 1 or more non-target lesions.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population||percentage of participants|||Number
156925|NCT00320385|Secondary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR was defined as the disappearance of all lesions (target and/or non-target). PR was defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)|ITT Population. Only participants with progesterone receptor status were considered for evaluation.||percentage of participants|||Number
156996|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Disease Stage: IIB|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB||percentage of participants|||Number
156928|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Primary Diagnosis of MDE|This assessment was completed by the physician at the screening visit. The physician decided which DSM-IV Diagnosis (as shown in outcome measure data table) best characterized the patient's primary diagnosis of MDE.|Screening|D-23 Original + TAU [(n= 330) + (n= 276)]. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
156929|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Intent of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's intent of their most recent suicidal gesture or attempt.~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
156930|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Medical Threat to Life of Most Recent Suicidal Gesture|"This assessment was completed by the physician at the baseline visit in a clinical interview. The physician decided which category (as shown in outcome measure data table) best characterized the patient's medical threat to life of their most recent suicidal gesture or attempt.~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 159 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
156931|NCT00320372|Post-Hoc|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Change From Baseline by Visit Month|The Q-LES-Q-SF is a self-report scale to assess the degree of enjoyment and satisfaction experienced by the patient during the past week. There are 2 forms of this instrument: the short form and the long form. The short form employs the 14 general activities included in the long form, as well as 2 global items. Five-point item scores (1 to 5) are aggregated, with higher scores indicative of greater enjoyment or satisfaction in each domain. The scoring of the Q-LESQ-SF involves summing only the first 14 items to yield a raw total score. The last 2 items are not included in the total score but stand alone. The raw total score ranges from 14 (worst score) to 70 (best score). Higher Q-LES-QSF score indicates more enjoyment and satisfaction (Endicott, Nee et al. 1993).|3-Month Through 60-Month (Post Baseline)|ITT Population minus D-21 Subjects: VNS Therapy Population (D-23=330) + (n= 276) TAU population. The total number of patients in each group is lower than ITT due to missing assessment data, for which a large portion is that of D-21 subjects. The Q-LES-Q-SF was not collected in the D-21 Study.||units on a scale||Standard Deviation|Mean
156932|NCT00320372|Secondary|Predictors of Suicidality Based on Montgomery Asberg Depression Rating Scale (MADRS) Item 10 Score - Baseline MADRS Item 10 Suicidal Ideation|"This assessment was completed telephonically by a third party rater (Central Rater Group). The rating was based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones, which allowed a precise rating of severity. The rater decided whether the rating lied on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5) and then checked the appropriate selection on the MADRS Item 10 Suicidal Thoughts (Ideation).~Total number of patients analyzed may be lower than ITT in a case of missing assessment data."|1 Week Pre-Baseline|D-23 Original + TAU [(n= 330) + (n= 276)] minus 2 missing assessment data. These risk factors assessed at baseline and pre-baseline were not collected with respect to treatment, therefore this information is not presented by treatment arm.||Percentage of Patients|||Number
156933|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Suicides/1000 Person Years)|The number of suicides per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Number of Suicides Per 1000 Person Years|||Number
156934|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Number of Suicides)|The number suicides on the study were collected from the baseline visit.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Number of Suicides|||Number
156935|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (All-Cause Mortality/1000 Person Years)|All cause mortality is defined as the number of deaths per calculated 1000 person years.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Deaths Per 1000 Person Years|||Number
156936|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Patient Years Exposed)|Treatment exposure time in years for all patients for all treatment groups were calculated in 1000 person year measure.|3-Month Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Exposure Per 1000 Patient Years|||Number
156937|NCT00320372|Post-Hoc|Mortality and Suicidality in Safety Population (Total Number of Deaths)|The number of deaths on the study were collected from the baseline visit.|3-Month (baseline or implantation) Through 60-Month (Post Baseline)|Safety Population (SP): VNS Therapy Population (n=494 (D-23=335 + D-21=159)) + (n= 301) TAU population||Number of Deaths|||Number
156938|NCT00320372|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)% Remitters (MADRS Total Score ≤9 at Visit Month Assessment Post-Baseline)|Remission is a binary outcome response variable (Yes/No Inremission) defined as MADRS total score < 9 at visit month assessment post-baseline. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen and in general it is accepted that a score between 0-6 is indicative of a normal/symptom-free individual; 7-19 is indicative of a patient with mild depression; 20-34 is indicative of a patient with moderate depression; and >34 is indicative of a patient with severe depression. Total number of patients in each group may be lower than ITT in a case of missing assessment data.|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population||Percentage of Participants|||Number
156939|NCT00320372|Secondary|Time Until Recurrence (TUR) for Patients That Achieved Remission, Based on Montgomery Asberg Depression Rating Scale (MADRS)|"Recurrence based on MADRS is defined as first time attained MADRS total score ≥ 20 after achieving remission. Remission is a binary outcome response variable (Yes/No in-remission) defined as MADRS total score </= 9 at visit month assessment post-baseline. Duration of remission Computed as recorded date of the first recurrence/relapse (MADRS score >/= 20) minus the recorded date of first achieved remission (MADRS score </=9). Only a subpopulation that achieved remission will be included in the summary.~Time-to-event analyses were summarized using Kaplan-Meier curves. Patients who did not achieve recurrence at the end of the study were censored on the last visit date recorded. Additionally, patients who discontinued early were censored on last date of contact. Censored observations and confidence intervals for the estimated median times were calculated."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population||Months|Participants|95% Confidence Interval|Median
156940|NCT00320372|Primary|Montgomery Asberg Depression Rating Scale (MADRS)% Responders (>/= 50% Improvement From Baseline)|"Response Rate was computed and summarized as the proportion of patients that achieved ≥ 50% reduction from baseline in MADRS total score at each post-baseline visit. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen. A patient was considered a “Responder” (Yes = 1) if achieved ≥ 50% reduction from baseline in MADRS total score at visit month assessment post-baseline. A “Non-Responder” (No = 0) was any patient who did not achieve ≥ 50% reduction from baseline in MADRS score at visit month assessment post-baseline.~Total number of patients in each group may be lower than ITT in a case of missing assessment data."|3-Month Through 60-Month (Post Baseline)|Intent-To-Treat (ITT) Population: VNS Therapy Population (n=489 (D-23=330 + D-21=159)) + (n= 276) TAU population||Percentage of Participants|||Number
156941|NCT00319644|Primary|Antibiotics Exposure Days|We hypothesize that Mini-BAL quantitative culture in place of tracheal aspirate culture will reduce the total days of antibiotics exposure|15 days|Random||days||Standard Deviation|Mean
156942|NCT00319644|Primary|Change in Antibiotic Usage or Exposure|We expect that 100-110 adult patients will have clinically suspected VAP over a 2-year period. We assume that 50 patients with suspected VAP will be randomized to mini-BAl, and 50 patients will be randomized to tracheal aspirate. We expect that patients randomized to tracheal aspirate group will receive an average of approximately 14 total days of antibiotics over their ICU stay. This study will have >80% power to detect a difference of 4 days of antibiotics (i.e. average of 10 days in mini-BAL group) with a 7-day standard deviation in both groups (alpha error level 5%).|It is theorized that patients randomized to the tracheal aspirate will receive an average of 15 days of antibiotics while patients randomized under the minibal arm will receive an average of 10 days of antibiotics|Of the 37 adult critically ill patients, 21 belonged to the tracheal aspirate (TA) group and 16 patients were classified as mini-BAL (MB) group.||days||Standard Deviation|Mean
156943|NCT00320281|Secondary|Rehabilitation Interference Scale (RIS)||2 weeks and 6 weeks post-injection||||||
156944|NCT00320281|Secondary|Respiratory Function Measures||2 weeks and 6 weeks post-injection||||||
156945|NCT00320281|Secondary|Patient Global Outcome Ratings||2 weeks, 6 weeks, and 6 months post-injection||||||
156946|NCT00320281|Secondary|Cervical Range of Motion Measurements||2 weeks and 6 weeks post-injection||||||
156947|NCT00320281|Secondary|Beck Depression Inventory||2 weeks and 6 weeks post-injection||||||
156948|NCT00320281|Secondary|Modified Leeds Neuropathic Symptoms and Signs Scale||2 weeks, 6 weeks, and 6 months post-injection||||||
156949|NCT00320281|Primary|Short-Form McGill Pain Questionnaire||2 weeks, 6 weeks, and 6 months post-injection||||||
156950|NCT00320281|Primary|Brief Pain Inventory-SF||2 weeks, 6 weeks, and 6 months post-injection||||||
156951|NCT00320281|Primary|Numerical Rating Scale-NRS|"The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the worst possible pain they have experienced and 0 being no pain."|6 weeks post-injection|||units on a scale||95% Confidence Interval|Mean
156952|NCT00320255|Primary|Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding|"Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:~A decrease in hemoglobin of 20 g/L or more or~Required transfusion of 2 or more units of packed red blood cells or whole blood, or~Occurred in a critical site~Contributed to death.~CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:~Skin hematoma~Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention~Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract~Any other bleeding type that was considered to have clinical consequences."|From first dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156953|NCT00320255|Secondary|Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants|||Number
156954|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
157077|NCT00318812|Secondary|Ferritin|Comparison of Ferritin at 6 months between the 2 Groups|6 months|||ug/L||Inter-Quartile Range|Median
156955|NCT00320255|Secondary|Number of Participants With Distal Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156956|NCT00320255|Secondary|Number of Participants With Deep Vein Thrombosis|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156957|NCT00320255|Secondary|Number of Participants With Nonfatal Pulmonary Embolism|"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|||Participants||95% Confidence Interval|Number
156958|NCT00320255|Secondary|Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)|"Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156959|NCT00320255|Secondary|Number of Participants With All-Cause Death||First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156960|NCT00320255|Secondary|Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death|"VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156961|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156962|NCT00320255|Secondary|Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death|"Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 30 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156963|NCT00320255|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death|"VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:~New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS~Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.~Any 1 of the following was considered diagnostic for PE:~Constant intraluminal filling defects in 2 or more views on pulmonary angiography~Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram~A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect)~An abnormal VQ lung scan with satisfaction of either criterion 1 or 2~Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels."|First dose to 2 days following last dose of study drug|All participants who received at least 1 dose of study drug||Participants||95% Confidence Interval|Number
156964|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement (0-72) at Week 28|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 28 for participants who were retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 28|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Participants|||Number
156965|NCT00320216|Secondary|Number of Participants Who Achieved Psoriasis Area Severity Index (PASI) 75% Improvement at Week 32|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 32 for participants who were not retreated at Week 16. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 32|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Particpants|||Number
156966|NCT00320216|Secondary|Number of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (1) or Excellent (2) at Week 12|Number of participants achieving a physician global assessment (PGA)(1 [best] to 6 [worst]) score of clear or excellent at Week 12. The PGA is used to determine the participants psoriasis lesions overall at a given time point. Overall lesions will be graded for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score.|Week 12|Participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Participants|||Number
156967|NCT00320216|Primary|Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12|Psoriasis Area and Severity Index (PASI)(0 [ best] -72 [worst]) score at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.||Participants|||Number
156968|NCT00320190|Secondary|Median Time to Progression-free Survival|Progression-free survival is defined as the time in days from randomization to progressive disease documented by the investigator or to death from any cause without prior progression. Participants without progressive disease or who do not die and complete the 12-month treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression or death (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
156969|NCT00320190|Secondary|Median Time to Treatment Failure|Time to treatment failure is defined as the time in days from randomization to progressive disease documented by the investigator, to death from any cause without prior progression, or to early treatment discontinuation for any reason, whichever occurs first. Participants without disease progression or who do not die and complete the 12-month study treatment are censored on the date of their last molecular, cytogenetic, or hematologic assessment.|Randomization to disease progression, death, or discontinuation (to 12 months)|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
156970|NCT00320190|Secondary|Percentage of Participants With Complete Cytogenetic Response|Cytogenetic response is based on the prevalence of Ph+ metaphases among cells in metaphase in a bone marrow sample.|At 6 and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
156971|NCT00320190|Secondary|Median Time to MMolR|Time to MMolR is defined as the time from first treatment dose until measurement criteria are first met for MMolR. MMolR is defined as a reduction in transcript levels of the BCR-ABL gene of at least 3 log from baseline.|At 3, 6, 9, and 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
156972|NCT00320190|Secondary|Percentage of Participants With On-study AEs of Special Interest|GI=gastrointestinal. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. Grade 1=mild; Grade 2=moderate; Grade 3=severe and undesirable; Grade 4=life-threatening or disabling; Grade 5=death. Percentages based on the number of participants with a specific grade at baseline. Participants without on-study test values for a particular laboratory analyte are not included in the reporting of that analyte.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.||Percentage of Participants|||Number
156973|NCT00320190|Secondary|Percentage of Participants With Death as Outcome, Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, persistent or significant disability/incapacity, drug dependency, or drug abuse; prolongs inpatient hospitalization; or is life-threatening, a congenital anomaly/birth defect, or an important medical event. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Months 1 to 12, continuously, and Months 12 to 24, continuously|All participants who received at least 1 dose of dasatinib or imatinib.||Percentage of participants|||Number
156974|NCT00320190|Primary|Percentage of Participants With Chronic Phase Chronic Myeloid Leukemia Who Have a Major Molecular Response (MMolR)|MMolR is defined as reduction in transcript levels of the breakpoint cluster region (BCR)-V-abl Abelson murine leukemia viral oncogene homolog 1 (ABL) gene of at least 3 log. The BCR-ABL gene has a role in the production of a mutated protein that converts bone marrow stem cells from normal to leukemic.|At 12 months from baseline|Efficacy analyses as originally described in the protocol were not conducted because of the low number of participants enrolled.|||||
157078|NCT00318812|Primary|Hemoglobin Concentration at 6 Months||6 months|||g/L||Inter-Quartile Range|Median
157079|NCT00318708|Secondary|Adverse Events||Measured during the 16-week treatment period||||||
156977|NCT00320112|Secondary|Change in Systolic Blood Pressure Measure|secondary outcome measure was change in blood pressure comparison of peer support group and nurse case management group from baseline to six months|change in blood pressure at 6 months|comparison of blood pressure measure taken at baseline and then again at 6 months among the two groups. as noted, 113 peer support participants provided physiologic measures at 6 months and 103 of 119 from the nurse management group provided physiologic measures at 6 months.||mmHg||Standard Deviation|Mean
156978|NCT00320112|Primary|Change in Glycemic Control (HbA1c)|The primary outcome was change between baseline and six-month Hemoglobin A1c (HbA1c), measured with a Bayer DCA 2000+ point-of-care analyzer.|6 months (baseline to 6 months)|Peer Support group: 117 of the 125 provided 6 month data and 113 provided physiologic measures. Nurse Case management participants: 114 of 119 provided 6 month data and 103 provided follow-up physiologic measures.||percent HbA1c||Standard Deviation|Mean
156979|NCT00319982|Secondary|Impact of Diltiazem on Systolic Blood Pressure|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits|||mmHg||Standard Error|Mean
156980|NCT00319982|Secondary|Adherence to Study Medication|Adherence to study medication was assessed by pill count|Duration of the trial|||percentage of pills taken||Standard Deviation|Median
156981|NCT00319982|Secondary|Development of Left Ventricular Hypertrophy|The number of participants who developed overt left ventricular hypertrophy during the duration of the trial was analyzed|Baseline through final study visits|||participants|||Number
156982|NCT00319982|Secondary|Left Ventricular Cavity Size|Change in Left Ventricular End-Diastolic Diameter z-score (Final Value - Baseline Value)|Baseline and final study visits|||z-score units||Standard Error|Mean
156983|NCT00319982|Secondary|Impact of Diltiazem on Heart Rate|Change in Value (Difference between Final and Baseline Visits)|Baseline and final study visits|||beats/minute||Standard Error|Mean
156984|NCT00319982|Secondary|Safety and Tolerability of Diltiazem Treatment|Adverse events were compared between participants assigned to diltiazem and those assigned to placebo|Baseline through final study visits|||Participants Reporting Adverse Events|||Number
156985|NCT00319982|Primary|Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity|The change in E' velocity (difference between final value - baseline value) was compared between participants who received diltiazem and those who received placebo to gauge treatment response. Please note that the total duration on treatment varied between study subjects to maximize time on treatment for the trial. Specifically, subjects that enrolled earliest had the longest duration of treatment; those who enrolled latest had the shortest duration of treatment with a minimum treatment duration of 1 year. All analyses examine the final study visit on treatment to the baseline visit.|Baseline and final study visits|||cm/sec (difference final-baseline)||Standard Error|Mean
156986|NCT00319748|Secondary|Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)|Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 9 patients had recorded values at 6 hours after treatment and were included in analysis.||pg/mL||95% Confidence Interval|Mean
156987|NCT00319748|Secondary|Mean Difference Values for Soluble CD40 Ligand (sCD40L)|Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have recorded value at 6 hours after treatment and cannot be included in analysis.||pg/mL||95% Confidence Interval|Mean
156988|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)|Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Two patients did not have recorded values at 6 hours after treatment so cannot be included in analysis.||pg/mL||95% Confidence Interval|Mean
156989|NCT00319748|Secondary|Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)|Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|Only 5 patients had a value reported at 6 hours after treatment.||pg/mL||95% Confidence Interval|Mean
156990|NCT00319748|Secondary|Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)|Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 Hours Post-Dose|One patient did not have a value reported at 6 hours after treatment so cannot be included in analysis.||pg/mL||95% Confidence Interval|Mean
156991|NCT00319748|Secondary|Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)|Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.|Prior to Dose 1 and 6 hours after Dose 1|One patient did not have value reported at 6 hours after treatment, so cannot be included.||pg/mL||95% Confidence Interval|Mean
156992|NCT00319748|Primary|Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.|Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.|after 12 weeks (24 doses of 852A)|Includes only patients that received all 24 doses of 852A.||Participants|||Number
156993|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Squamous Cell|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB||percentage of participants|||Number
156994|NCT00319735|Secondary|Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma|To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas|36 months|patients with IIB||percentage of participants|||Number
157080|NCT00318708|Secondary|AM Cortisol||Measured during the 16-week treatment period||||||
157001|NCT00319735|Secondary|Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas that underwent esophagectomy.~Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|Up to 36 months|Participants who underwent esophagectomy||percentage of participants||95% Confidence Interval|Number
157002|NCT00319735|Primary|Complete Pathologic Response (pCR)|"To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas.~Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction."|36 months|||percentage of participants|||Number
157003|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS)|UKFS relates to upper and lower extremity function and muscle weakness. For each item, the patient indicated the responses that best described their current ability: “able to perform in a normal manner,” “able to perform with alteration in style,” “can only manage with difficulty,” and “impossible to achieve.” Each response was given an integer from 0 (able to perform in a normal manner) to 3 (impossible to achieve), and the sum of individual responses provided an overall score of 0 to 33. Missing values were replaced with the worst value the patient reported on the other items at that visit.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 98, 93, 84, 82, and 78, respectively||score on a scale||Standard Deviation|Mean
157004|NCT00319696|Primary|Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers|Overall hand pain related to finger ulcers was assessed by the patient using a Visual Analogue Scale. Patients were instructed to score their pain by marking on the continuous 10-cm scale, where 0 (left) was no pain and 100 (right) very severe pain, in response to the question, “How much pain have you had because of your finger ulcers in the past week?” The investigator measured the distance in millimeters between 0 and the patient mark with the ruler provided and recorded the distance.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 110, 94, 89, 81, 76, and 73, respectively||mm||Standard Deviation|Mean
157005|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157006|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157007|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157008|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157009|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157010|NCT00319696|Secondary|Adverse Events Leading to Permanent Discontinuation of the Study Medication|Number of patients with an adverse event leading to permanent discontinuation of the study treatment|80 weeks|Study population||participants|||Number
157011|NCT00319696|Secondary|Serious Adverse Events up to 28 Days After Last Study Medication|Number of patients with at least one treatment-emergent serious adverse event. Adverse events that occurred after study drug initiation and up to 28 days after study drug discontinuation.|80 weeks|Study population||participants|||Number
157012|NCT00319696|Secondary|Adverse Events up to 24 Hours After Last Study Medication|Number of patients with at least one treatment-emergent adverse event. All adverse events that occurred after study drug initiation and up to 24 hours after study drug discontinuation were to be recorded.|80 weeks|Study population||participants|||Number
157013|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157014|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising|"SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: without any difficulty, with some difficulty, with much difficulty, or unable to do, equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities."|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157015|NCT00319696|Primary|Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing|SHAQ evaluates physical disability. Patients were instructed to rate their capacity to perform activities of daily living within the previous 7 days by checking one of the following descriptors: “without any difficulty”, “with some difficulty,” “with much difficulty,” or “unable to do,” equivalent to scores of 0, 1, 2, and 3, respectively. Items were categorized into 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.|80 weeks|number of participants at baseline, week 16, week 32, week 48, week 64, and week 80 was 116, 99, 93, 85, 82, and 78, respectively||scores on a scale||Standard Deviation|Mean
157016|NCT00319696|Primary|Time to Complete Healing of Each New DU||New DU occurence to healing|Complete healing of each new DU was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on DU healing originally planned time to complete healing of new DUs was not evaluated.|||||
157017|NCT00319696|Primary|Time to Complete Healing of Each Baseline DU||Baseline to healing|Complete healing of each baseline was not calculated due to the lack of effect on healing variables seen in the previous placebo-controlled study (RAPIDS 2). In consequence, the endpoint on time to complete healing of baseline DUs was not evaluated.|||||
157018|NCT00319696|Primary|Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits|The total number of new DUs per patient observed by the investigator at planned visits and new transient DUs recorded in the patient diary (a patient diary was used to record DUs that might appear and disappear between two planned visits)were assessed at each clinic visit|At planned visits up to week 80|One patient did not have a DU at baseline (number of patients assessed at Weeks 0-4,4-8,8-16,16-24,24-32,32-40,40-48,48-56,56-64,64-72, and 72-80 were 114, 107, 103, 100, 97, 94, 88, 87, 86, 86, and 83, respectively.||number of new digital ulcers|||Number
157019|NCT00319592|Primary|Number of Participants Reporting at Least One Treatment Emergent Adverse Event Following Vaccination With Either ChimeriVax™ JE or JE-VAX®|Grade 3 (severe) adverse events were defined as incapacitating with inability to work or perform usual activity.|Day 0 up to Day 6 post-vaccination|Adverse events were assessed in all participants who received at least one dose of study vaccine pr saline (Intent to Treat Population).||Participants|||Number
157020|NCT00319592|Primary|Mean Antibody Titers to the Respective Homologous JE Vaccine Strain Post Vaccination With Either ChimeriVax™-JE or JE-VAX®|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) up to month 12 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).||1/dilutions||Standard Deviation|Mean
157021|NCT00319592|Primary|Number Participants That Were Seropositive to the Respective Homologous JE Vaccine Strain Before and Post-Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine.|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined as seropositive if they had an antibody titer of ≥ 1:10. [Seropositive status can be 'Yes' or 'No']|Day 0 (Pre-vaccination) and up to Month 12 After First Dose|Seropositive status was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).||Participants|||Number
157022|NCT00319592|Primary|Mean Antibody Titers of the Respective Homologous JE Vaccine Strain After the First Active Vaccination With Either JE-Vax ® or ChimeriVax™-JE|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50).|Day 0 up to Day 56 post-vaccination|Antibody titers were assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per Protocol Population).||1/dilutions||Standard Deviation|Mean
157023|NCT00319592|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain Up to 28 Days After the First Active Vaccination With Either ChimeriVax™-JE or JE-VAX® Vaccine|Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of < 1:10.|Day 0 (pre-vaccination) and up to Day 56 post-vaccination|Seroconversion was assessed in all participants who were seronegative at baseline, received the complete vaccine regimen, and had no significant protocol deviations (Per-Protocol Population).||Participants|||Number
157081|NCT00318708|Secondary|Blood Cell Counts||Measured during the 16-week treatment period||||||
157027|NCT00319553|Primary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®|"Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities."|Day 0 to 7 post-vaccination|Solicited injection site and Systemic reactions were analyzed in the intent-to-treat safety population||Participants|||Number
157028|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Open-label Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From Visit 2 and subsequent visits in the Open-label Period to discharge or study termination|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for evaluation.||Units on a scale||Standard Deviation|Mean
157029|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Open-label Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period and who were available for participation.||Units on a scale||Standard Deviation|Mean
157030|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.||Participants|||Number
157031|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Open-label Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient’s diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself.|From 15 minutes to 12 hours after study drug administration for onset of an episode of ARS during the Open-label Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.||Participants|||Number
157032|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Open-label Period|Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode.|From 15 minutes to 12 hours after study drug administration during the Open-label Period|All randomized participants in whom an attempt (successful or not) was made to administer study drug for an ARS episode during the Open-label Period of the study.||Participants|||Number
157033|NCT00319501|Secondary|Mean Score on Physician Global Treatment Assessment During the Double-blind Period|Physician global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes. The physician global evaluation is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|At Visit 2 and subsequent visits in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.||Units on a scale||Standard Deviation|Mean
157034|NCT00319501|Secondary|Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period|Caregiver global evaluation is based on seizure frequency, severity, and overall outcome compared with previous episodes and is rated on a 10-cm visual analogue scale, where 0=much worse and 10=much better. A higher score indicates greater improvement. An episode of acute repetitive seizures (ARS) is defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|Assessments completed at the end of each treated episode of ARS in the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.||Units on a scale||Standard Deviation|Mean
157082|NCT00318708|Secondary|Exhaled Nitric Oxide (eNO)||Measured during the 16-week treatment period||||||
157083|NCT00318708|Secondary|Methacholine Provocative Concentration (PC20)||Measured during the 16-week treatment period||||||
157035|NCT00319501|Secondary|Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period|Other rescue medical care consisted of care other than rescue medication or emergency department visits. Each patient's specific criteria for seizure and an episode of acute repetitive seizure (ARS) were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.||Participants|||Number
157036|NCT00319501|Secondary|Number of Participants Requiring Emergency Department Visits During the Double-blind Period|Any use of emergency treatment (such as an emergency room visit) was recorded in the patient’s diary, along with the date, time, and reason for the emergency treatment. Emergency department visits required some type of rescue action taken, other than the visit itself. An episode of acute repetitive seizures (ARS) was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for onset of an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an episode of ARS during the Double-blind Period.||Participants|||Number
157037|NCT00319501|Secondary|Number of Participants Requiring Rescue Medication During the Double-blind Period|If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the acute repetitive seizure (ARS) episode. Each patient's specific criteria for seizure and an episode of ARS were determined by the Investigator. Patients and their caregivers were trained to use these criteria to recognize the onset of an episode of ARS and when and how to administer study drug. An episode of ARS was defined as an episode of multiple complex, partial, or generalized seizures occurring over a brief period (minutes to 12 hours) with the patient regaining consciousness between seizures, which were readily recognizable by the patient or a trained caregiver. ARS includes seizures sometimes referred to as serial, cluster, crescendo, or stuttering prolonged.|From 15 minutes to 12 hours following study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS during the Double-blind Period.||Participants|||Number
157038|NCT00319501|Primary|Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Open-label Period.||Percentage of participants|||Number
157039|NCT00319501|Primary|Time to Next Seizure or Rescue Medication During the Double-blind Period (Kaplan-Meier 50th Percentile)|An event was defined as an episode of or required rescue medication for an episode of acute repetitive seizures (ARS) within 15 minutes to 12 hours following study drug administration. Patients without an ARS event were censored at 12 hours. Diaries were provided; if no diary was returned, or the diary did not provide answers to questions about seizures and rescue during the 12-hour follow-up period, the patient was considered censored as of 15 minutes past the treatment time, unless another contact was documented. If seizure control following study drug administration was inadequate, diazepam rectal gel was provided as a rescue medication, given only in the first 4 hours after study drug administration and only if the caregiver was directed to do so by the Investigator or designee at the time of the ARS episode. Patients and their caregivers were trained to recognize the onset of an episode of ARS and when and how to administer study drug.|From 15 minutes to 12 hours after study drug administration for an episode of ARS during the Double-blind Period|All randomized participants for whom an attempt (successful or not) was made to administer study drug for an ARS event during the Double-blind Period.||Hours||95% Confidence Interval|Median
157040|NCT00319449|Secondary|High Density Lipoprotein-cholesterol (HDL-C), Total Cholesterol and Triglycerides at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants and the high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol was measured with the basic lipid panel test.|6 weeks post treatment|Participants who completed the study.||mg/dL||95% Confidence Interval|Mean
157041|NCT00319449|Secondary|Number of Participants Who Achieve the Target LDL-C Concentration of < 3.3 mmol/L (130 mg/dL)|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5] after treatment for 6 weeks.|6 weeks post treatment|Participants who completed the study.||Participants|||Number
157084|NCT00318708|Secondary|Asthma-specific Quality of Life||Measured during the 16-week treatment period||||||
157085|NCT00318708|Secondary|Forced Expiratory Volume in One Second (FEV1)||Measured during the 16-week treatment period||||||
157042|NCT00319449|Primary|Low Density Lipoprotein-cholesterol (LDL-C) at Baseline and After 6 Weeks of Treatment With Ezetimibe 10 mg Added to Atorvastatin 10 mg Versus Placebo Added to Atorvastatin 10 mg|12-hour fasting blood samples were collected in participants to measure high density lipoprotein-cholesterol (HDL-C), triglycerides and total cholesterol. LDL-C was measured using Friedewald calculation (LDL-C = Total C - [HDL-C + TG/5]) before and after treatment.|Baseline and 6 weeks|Participants who completed the study.||mg/dL||95% Confidence Interval|Mean
157043|NCT00319436|Secondary|Maternal Substance Abuse (Assessed With Urine Toxicology Screens)|Maternal substance use was monitored weekly using results from weekly urine toxicology (UTOX) screens testing for presence of opiate, cocaine, and cannabis metabolites in urine samples collected at the outpatient clinic. For each month of the mother’s participation in the study, a mother received a score of “0” if no drug metabolites were present in any of her urine toxicology screens during that month or a score of “1” if one or more of her urine toxicology screens tested positive for a drug metabolite during that month. A percentage was calculated by= number of positive substance tests/number of total test *100 for each patients during each month.|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||% positive utox screens/month||Standard Error|Mean
157044|NCT00319436|Secondary|Maternal Psychiatric Distress (Assessed With the Brief Symptom Inventory)|The Brief Symptom Inventory (BSI; Derogatis, 1993) was used to assess maternal global psychiatric distress. The BSI is a standardized, widely used, 53-item, 5-point, self-report measure of psychopathology. The composite Global Severity Index (GSI) measures current overall symptomatology across multiple domains and has demonstrated good reliability and validityT-scores have a mean of 50 and a standard deviation of 10. Scores within one standard deviation (ie. a T-score of 10) above the mean on any dimension are regarded as being within the normal range on that dimension (Derogatis, 1993). These scores were converted to T-scores using data from the scoring manual. The higher the scores are worse.T scores above 60 on the GSI indicate risk for a clinical disorder.|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
157045|NCT00319436|Secondary|Maternal Depression (Measured With the Beck Depression Inventory)|The Beck Depression Inventory (BDI; Beck, Steer, & Brown, 1996) was used to assess maternal symptoms of depression. The BDI is a widely used 21-item questionnaire rated on a 4-point scale and yields a total score ranging from 0 to 63: scores between 13 and 19 indicate mild depression; scores between 20 and 28 indicate moderate levels of depression, and scores between 29 and 63 indicate severe levels of depression (Beck et al., 1996).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
157046|NCT00319436|Secondary|Child Behavior (Assessed With the NCAST Teaching Scales)|Child behavior with the mother was assessed using the Clarity of Cues and the Responsiveness to Caregiver Subscales from the NCAST Teaching Scales. The Child Total Score is the sum of the 2 scales (23 items) with scores ranging from 0 to 23. The Child Contingency Score is the sum of 12 contingent items from the 2 scales (with scores ranging from 0 - 12). The 2 subscores are summed to arrive at the composite score. Higher scores are better. The normative means for the children of high school educated mothers reported in the scoring manual: Total Child Score = 15.44 (4.29), Clarity of Cues = 7.99 (1.49), Responsiveness to Parent = 7.45 (3.16).|post-treatment and 6-wk follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
157047|NCT00319436|Secondary|Maternal Caregiving Behavior (Assessed With the NCAST Teaching Scales)|Mothers choose a task to teach the child in a 5 minute teaching session. Maternal behavior is coded on 4 dimensions: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, & Cognitive Growth Fostering. The Total Caregiver Score is the sum of the 4 subscale scores (73 items) with scores ranging from 0 to 73. The Total Caregiver Contingency Score is the sum of 20 items from the 4 subscales that involve the caregiver’s contingent response to child cues (scores range from 0 to 20). Higher score are better and lower scores are worse. For mothers with high school education (which a majority in our sample had) here are the normative means (SDs) reported in the scoring manual: Total Caregiver Score = 40.69 (6.85), Sensitivity to Cues = 9.16 (1.62), Response to Distress = 10.04 (1.78), Social-Emotional Growth = 8.99 (1.83), Cognitive Growth = 12.51 (3).|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
157048|NCT00319436|Primary|Quality of Maternal Representations of the Child (Assessed With the Working Model of the Child Interview)|The Working Model of the Child Interview (WMCI; Zeanah & Benoit, 1993) is a 1.5 hour interview used to elicit a narrative description of the mother’s perceptions of her child and their relationship. The rater was trained to reliably code 6 qualitative subscales: Openness, Richness, Coherence, Caregiving Sensitivity and Acceptance and Involvement. On the mean of six subscales, a score of three is considered to represent average representational quality, scores of 1 and 2 are considered to represent clinical risk and scores of 4 and 5 are considered to represent optimal quality.|post-treatment, 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
157086|NCT00318708|Secondary|AM and PM Peak Expiratory Flow (PEF)||Measured during the 16-week treatment period||||||
157049|NCT00319436|Primary|Maternal Capacity for Reflective Functioning (Assessed With the Parent Development Interview)|The Parent Development Interview (PDI) was used to measure maternal capacity to mentalize about her own and her child’s behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother’s narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.|post-treatment and 6-week follow up|Data analysis was conducted for ITT sample. Baseline data was available for 47 mothers. Missing post-tx and follow up scores for mothers who left treatment early were estimated as equal to baseline scores. Post-tx and follow up scores for mothers who completed treatment but not post-tx or follow up visits were estimated as equal to tx group means.||units on a scale||Standard Deviation|Mean
157050|NCT00319254|Other Pre-specified|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 2, 7, 20 hours post-dose on Day 1 of Week 4 and pre-dose on Day 1 of Weeks 1, 8, 12, 16, and 24||||||
157051|NCT00319254|Secondary|Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment|KPS: 11 level score ranged 100 to 0, to assess functional impairment. 100:Normal; 90:Able to carry on normal activity; 80:Normal activity with effort, some signs or symptoms of disease; 70:Cares for self, unable to carry on normal activity or to do active work; 60:Requires occasional assistance but is able to care for most of needs; 50:Requires considerable assistance and frequent medical care; 40:Disabled,requires special care and assistance; 30:Severely disabled; hospitalization indicated although death is not imminent; 20:Very sick; 10:Morbibund,fatal processes progressing rapidly; 0:Death.|Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.|||||
157052|NCT00319254|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to last dose of study treatment (Week 77) as a management of an AE were to be reported.|Day 1 up to end of treatment (Week 77)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.|||||
157053|NCT00319254|Secondary|Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations|Number of participants with potentially clinically significant (PCS) vital signs and physical examinations are reported. Criteria for PCS vital signs include: respiratory rate >25 breaths/minute and PCS physical examinations include: an increase or decrease from baseline of >=7% in body weight.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."||participants|||Number
157054|NCT00319254|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG)|Number of participants with potentially clinically significant (PCS) ECG findings are reported. Criteria for PCS ECG findings include: no sinus rhythm; heart rate >=120 beats per minute (bpm) or increase >=15 bpm; QT interval corrected using Bazett's formula (QTcB) >60 milliseconds (msec) change from baseline; and overall ECG evaluation not normal.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."||participants|||Number
157055|NCT00319254|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Number of participants with potentially clinically significant (PCS) laboratory values are reported. Criteria for PCS laboratory values include: aspartate aminotransferase (AST), alanine aminotransferase (ALT) >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); total bilirubin >3*ULN micromole/L; sodium <130, magnesium <0.4 and >1.23 millimole/L; lipase >2*ULN microkats/L; neutrophils <1*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 77)|"Safety population included all enrolled participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) represents number of participants who had at least 1 on-treatment assessment."||participants|||Number
157056|NCT00319254|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as a confirmed CR or PR, or stable disease (SD) for more than (>) 24 weeks as the best response before the first evidence of progressive disease (PD). A participant demonstrating CR, PR, or SD >24 weeks at any time while on study was counted in the numerator.|Baseline up to end of treatment (Week 77)|ITT population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
157057|NCT00319254|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was based on the assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to sponsor modified Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions. Confirmed PR defined as more than or equal to (>=) 30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline up to Year 1|ITT population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
157058|NCT00319254|Secondary|Overall Survival (OS)|OS was estimated by Kaplan-Meier method. Survival was defined as the time period from the date of first dose of study treatment to the date of death, censored at the participant's last contact date. Percentage of participants who were still alive at 2 years is reported.|Baseline up to Year 2|ITT population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
157087|NCT00318708|Secondary|Asthma Rescue Medication Use||Measured during the 16-week treatment period||||||
157088|NCT00318708|Secondary|Asthma Symptoms||Measured during the 16-week treatment period||||||
157059|NCT00319254|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 30 days after last dose of study treatment|Safety population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants|||Number
157060|NCT00319254|Primary|Progression-Free Survival (PFS) Rate|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.|Baseline up to Week 16|Intent-To-Treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.||percentage of participants||95% Confidence Interval|Number
157061|NCT00319111|Secondary|Occurrence of Liver Function Test and Hemoglobin Abnormality|Number of patients with an increase in liver aminotransferases to >3 times upper limit of normal (ULN) or a decrease in hemoglobin concentration to ≤10 g/dL|Until discontinuation of study drug, up to 3.3 years|study population||participants|||Number
157062|NCT00319111|Secondary|Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation||28 days after discontinuation of study drug, up to 3.3 years|Study population||participants|||Number
157063|NCT00319111|Secondary|Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication||Until discontinuation of study drug, up to 3.3 years|Study population||participants|||Number
157064|NCT00319111|Primary|Time to Clinical Worsening up to End-of-study|An event of clinical worsening was defined as death during the treatment period, a treatment-emergent adverse event that led to permanent discontinuation of study treatment and with outcome death, hospitalization due to worsening pulmonary hypertension, or lung transplantation. Patients are censored at 1 day after the end of treatment or at day of pulmonary endarterectomy if earlier.|Until discontinuation of study drug, up to 3.3 years|Study population||participants|||Number
157065|NCT00319111|Primary|Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)|"Disease severity was assessed by WHO classification of PH criteria:~Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope.~Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.~Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope.~Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA."|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 138, 129, 123, 109, and 139 respectively||participants with improved WHO class|||Number
157066|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in Borg Dyspnea Index|Maximal dyspnea during the walk test was assessed by the patient using the Borg dyspnea index. Immediately following each walk test, patients rated perceived maximal breathlessness during the walk test on a 12-point scale (0 [nothing at all], 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 [maximum ever experienced]).|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 136, 127, 120, 105, and 136 respectively||Scores on a scale||Standard Deviation|Mean
157067|NCT00319111|Primary|Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance|Exercise capacity was assessed using the 6MWT. Area used for testing had to be a minimum of 30m in length and 2-3m in width, with 3m gradations. Areas were well ventilated with air temperature controlled. The test was administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6min period. If the test was stopped before 6 minutes, the main reason for stopping the test was recorded. The tester measured the distance walked by patients during the timed 6min period.|Until discontinuation of study drug, up to 3.3 years|Numbers of patients assessed at 6 month, month 12, month 18, month 24 and end of the treatment period were 137, 128, 121, 106, and 137 respectively||walk distance change from baseline (m)||Standard Deviation|Mean
157068|NCT00319046|Secondary|Percent Change in Spleen Volume|Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat||percentage change||Standard Deviation|Mean
157069|NCT00319046|Primary|Percent Change in Liver Volume|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|One patient was excluded from analysis as the baseline liver volume not available||percentage change||Standard Deviation|Mean
157070|NCT00319046|Secondary|Spleen Volume|Spleen volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|The analysis was performed on those non-splenectomized patients who had a post-baseline assessment of spleen volume while on treatment with miglustat||cm^3||Standard Deviation|Mean
157071|NCT00319046|Primary|Liver Volume|Liver volume was assessed at baseline and end of treatment by magnetic resonance imaging|baseline to end of treatment (month 24 or imputed value)|One patient was excluded from analysis as the baseline liver volume not available||cm^3||Standard Deviation|Mean
157072|NCT00318929|Secondary|Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)|Seizure Severity Questionnaire summary score, on a scale of 1 to 7 with one being the least severe and 7 being the most severe, components of seizures include; warning, activity and recovery|24 weeks||||||
157073|NCT00318929|Secondary|Number of Seizures Per Month|Count of seizures per month determined by seizures recorded in diaries.|24 weeks||||||
157089|NCT00318708|Primary|Juniper Asthma Control Questionnaire (ACQ) Results|The Juniper asthma control questionnaire (ACQ) consists of six questions answered by the asthma patient with respect to symptoms, rescue medication use, and night-time awakenings due to asthma. A seventh item in the ACQ is the percent predicted FEV1. Each of the seven items is scored from from 0 (best) to 6 (worst), and then the seven items are averaged to yield a number from 0 (best) to 6 (worst). Asthma patients needed to display an ACQ greater than or equal to 1.25 in order to be eligible for randomization. A reduction of 0.5 units or more in the ACQ over the 16 weeks of treatment is considered to be clinically significant.|Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome|The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).||units on a scale||Standard Error|Least Squares Mean
157090|NCT00318656|Secondary|Glycaemia According to CGMS (MAGE), mg/dL|Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
157091|NCT00318656|Secondary|Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
157092|NCT00318656|Secondary|Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
157093|NCT00318656|Secondary|Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations. The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
157094|NCT00318656|Secondary|Glycaemia According to CGMS (Dawn), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia “at dawn” measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
157095|NCT00318656|Secondary|Glycaemia According to CGMS (Diurnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
157096|NCT00318656|Secondary|Glycaemia According to CGMS (Nocturnal), mg/dL|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)||mg/dL||Standard Error|Mean
157097|NCT00318656|Secondary|8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate|8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal. The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.|Baseline and 12 weeks|ITT (randomized)||pg/mL||Standard Error|Mean
157098|NCT00318656|Secondary|HbA1c (Glycosylated Hemoglobin)|Uncontrolled HbA1c>8.5%. HbA1c and fasting blood glucose taken at hospital|Baseline and 12 weeks|ITT (randomized)||Percentage||Standard Error|Mean
157099|NCT00318656|Secondary|Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
157100|NCT00318656|Secondary|Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Hours||Standard Error|Mean
157101|NCT00318656|Secondary|Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
157102|NCT00318656|Secondary|Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Hours||Standard Error|Mean
157103|NCT00318656|Secondary|Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
157104|NCT00318656|Secondary|Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Hours||Standard Error|Mean
157105|NCT00318656|Primary|Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized)||Episodes||Standard Error|Mean
157106|NCT00318656|Primary|Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment|Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.|Baseline and 12 weeks|ITT (randomized): This Intent-to-treat (ITT) population included all subjects who had been randomised, who had received at least one dose of study medication, and for whom at least one efficacy criteria on treatment period was available. The ITT population was the primary population for the efficacy analysis.||Hours||Standard Error|Mean
157111|NCT00318591|Secondary|Nurse Evaluation of Catheters - Overall Satisfaction|Evaluation score on an 11-point scale from 0-10 (0 being lowest satisfaction)|4-6 months|Analysis were done on evaluations of the ITT-population. Evaluations were made at discharge from hospital. Since some participants discontinued the study prior to discharge and since some did not fill in the evaluation form, the total number of evaluations (132) do not add up to the total of the ITT population (219)||scores on a scale||Standard Deviation|Mean
157112|NCT00318591|Secondary|UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml|UTIs with bacteriuria >=100 Colony Forming Units (CFU)/ml. Descriptive analysis|4-6 months|Descriptive only||UTI|||Number
157113|NCT00318591|Primary|Occurrence of Symptomatic Urinary Tract Infections (UTIs)|Occurrence of symptomatic urinary tract infections (UTIs). Time to first UTI|4-6 months|ITT-population, symptomatic urinary tract infections treated with antibiotics||participants|||Number
157114|NCT00318565|Primary|Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.|The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.|7 Days|||percentage of participants||95% Confidence Interval|Mean
157115|NCT00318565|Primary|Percentage of Subjects With Complete Bidirectional Conduction Block.|Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.|During the procedure|"Per protocol analysis. Number differs from Participant Flow because only 253 subjects were considered for the efficacy cohort."||percentage of participants||95% Confidence Interval|Mean
157116|NCT00318474|Secondary|Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level||12 months||||||
157117|NCT00318474|Primary|Change in Proteinuria - Uprotein/Creatinine Ratio|Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.|Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.|||ratio||Standard Deviation|Mean
157118|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 104|Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-104|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.||episodes|||Number
157119|NCT00318461|Secondary|Hypoglycaemic Episodes at Week 26|Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.||episodes|||Number
157120|NCT00318461|Secondary|Change in Beta-cell Function at Week 104|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point (%point)||Standard Error|Least Squares Mean
157121|NCT00318461|Secondary|Change in Beta-cell Function at Week 26|"Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).~Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5)."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point (%point)||Standard Error|Least Squares Mean
157122|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
157123|NCT00318461|Secondary|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
157142|NCT00318370|Secondary|Overall Response Rate|The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, “complete response” (CR), “partial response” (PR), “stable disease” (SD), or “progressive disease” (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.|Baseline to response (up to 44 months)|||percentage of participants|||Number
157124|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
157125|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 104|Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage of total haemoglobin||Standard Error|Least Squares Mean
157126|NCT00318461|Secondary|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26|"Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.~Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three."|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/l||Standard Error|Least Squares Mean
157127|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 104|Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
157128|NCT00318461|Secondary|Change in Fasting Plasma Glucose (FPG) at Week 26|Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mmol/L||Standard Error|Least Squares Mean
157129|NCT00318461|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of treatment)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
157130|NCT00318461|Secondary|Change in Body Weight at Week 26|Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
157131|NCT00318461|Primary|Change in Glycosylated A1c (HbA1c) at Week 26|Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)|week 0, week 26|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||Percentage point of total HbA1c||Standard Error|Least Squares Mean
157132|NCT00318409|Primary|Acceptability: Proportion of Participants Discontinuing Medication in Both Arms|Proportion of participants who discontinued study medication for at least one week prior to study completion.|12 weeks|||percentage of discontinuations|||Number
157133|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report|Proportional of reported days taking study drug during the 12 weeks of study.|12 weeks|||percentage of self-reported adherence|||Number
157134|NCT00318409|Primary|Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings|Proportion of days in which the MEMS cap device was opened during of the 12 weeks on study drug.|12 weeks|||percentage adherence by MEMS|||Number
157135|NCT00318409|Primary|Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.||throughout study|||number of adverse events|||Number
157136|NCT00318409|Primary|Feasibility: Participants Who Completed the Trial||12 weeks|||participants who completed the trial|||Number
157137|NCT00318409|Primary|Feasibility: Proportion of Urine Samples Collected||12 weeks|||Urine samples collected|Participants||Number
157138|NCT00318409|Primary|Feasibility: Proportion of Scheduled Study Visits Completed||12 weeks|||Scheduled study visits completed|Participants||Number
157139|NCT00318409|Primary|Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled||At Enrollment|||Eligible persons screened who enrolled|||Number
157140|NCT00318370|Secondary|Percentage of Participants Who Had a Prolongation of Remission|Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator’s assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.||percentage of participants||95% Confidence Interval|Number
157141|NCT00318370|Secondary|Progression-free Survival (PFS)|PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 >2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.|Baseline to response (up to 44 months)|All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.||Months||95% Confidence Interval|Median
157143|NCT00318370|Secondary|Duration of Serologic Response (CA-125)|Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being >2 X ULN on two occasions.|Baseline to response (up to 44 months)|All participants enrolled to initial chemotherapy plus farletuzumab.||Months||95% Confidence Interval|Median
157144|NCT00318370|Secondary|Time to Serologic Response (Change in CA-125 Level)|Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.|Baseline to response (up to 27 weeks)|All participants enrolled to intial chemotherapy plus farletuzumab.||Weeks||95% Confidence Interval|Median
157145|NCT00318370|Primary|Serologic Response (Change in Cancer Antigen [CA-125] Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 27 weeks)|All participants enrolled to chemotherapy plus farletuzumab.||participants|||Number
157146|NCT00318370|Primary|Serologic Response (Change in CA125 Level)|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).|Baseline to response (up to 30 weeks)|All participants enrolled to initial farletuzumab only.||participants||95% Confidence Interval|Number
157147|NCT00318292|Primary|Visual Analogue Scale (VAS) Pain Score|Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.|30 minutes post-op|||points on a scale||Standard Deviation|Mean
157148|NCT00318136|Secondary|Progression-free Survival|"Progression−free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab.~Summary of PFS (median) was estimated from Kaplan−Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley."|Length of study|Enrolled patients||Months||95% Confidence Interval|Median
157149|NCT00318136|Secondary|Adverse Events That Led to Discontinuation of Bevacizumab|Any treatment-emergent adverse event leading to study treatment discontinuation|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients||Patients|||Number
157150|NCT00318136|Secondary|Selected Adverse Events|"Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions.~Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients||Patients|||Number
157151|NCT00318136|Primary|Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events|"To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."|First bevacizumab administration until 60 days after discontinuation of bevacizumab or death|Safety-evaluable patients||Percentage of patients|||Number
157152|NCT00317941|Secondary|Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants|"if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction.~An injection site is seen as developing no reaction if the patient’s score for this site is of a reaction intensity = 0."|Up to 3 months assessed every 48 hours after each injection|||Percentage of sites|Participants||Number
157153|NCT00317941|Secondary|Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants||Up to 3 months assessed every 24 hours after each injection|||Percentage of sites|Participants||Number
157154|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|24h after injection|||Scores on a scale||Full Range|Mean
157155|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|1h after injection|||Scores on a scale||Full Range|Mean
157156|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|30 min after injection|||Scores on a scale||Full Range|Mean
157157|NCT00317941|Secondary|Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection|Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).|Immediately after injection|||Scores on a scale||Full Range|Mean
157158|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection|||Percentage of injection sites|Participants||Number
157159|NCT00317941|Secondary|Percentage of Injection Sites Without Pain Reported by Physicians||Up to 3 months|||Percentage of injection sites|Participants||Number
157160|NCT00317941|Secondary|Percentage of Participants Without Pain Reported by Participants||Up to 3 months assessed 24 hours after each injection|||Percentage of participants|||Number
157161|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 48 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 48 hours after each injection|||Percentage of sites|Participants||Number
157162|NCT00317941|Secondary|Percentage of Sites Developing a Severe Reaction 24 Hours After Injection|An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis|Up to 3 months assessed every 24 hours after each injection|||Percentage of sites|Participants||Number
157166|NCT00317941|Other Pre-specified|Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months|||Scores on a scale|Participants|Standard Deviation|Mean
157167|NCT00317941|Primary|Mean Scores of Reaction After Injection Reported by Participants|Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis|Up to 3 months assessed every 24 and 48 hours after injection|||Scores on a scale|Participants|Standard Deviation|Mean
157168|NCT00317941|Primary|Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection|An injection site is seen as developing a reaction if the patient’s score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 48 hours after each injection|||Percentage of sites|Participants||Number
157169|NCT00317941|Primary|Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection|An injection site is seen as developing a reaction if the patient’s score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed|Up to 3 months assessed every 24 hours after each injection|||Percentage of sites|Participants||Number
157170|NCT00317720|Primary|Clinical Benefit Response Rate (CBR)|Efficacy measured by the clinical benefit response rate (CBR), defined as confirmed Complete Response (CR) plus Partial Response (PR) at any time plus Persistent Stable Disease (pSD). Confirmed CR is defined as disappearance of all target lesions at the time of radiographic evaluation; pSD was defined as SD lasting 24 weeks. Complete Response (CR): disappearance of all target lesions, and Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as a reference the baseline sum LD. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started.|6 weeks|||percentage of partcipants|||Number
157171|NCT00317720|Primary|Optimal Dose of RAD001 in Combination With Trastuzumab (Phase I)|"In Phase I, two dose levels of RAD001 were studied: 10 mg (dose level 1) and 5 mg (dose level -1) where each dose was evaluated after cycle 1. At MDACC, the Continual Reassessment Method (CRM) for determining Maximum Tolerated Dose (MTD) was applied to the two predefined RAD001 dose levels; and at DFCI/BIDMC, a 3 x 3 study design was utilized.~Optimal dose defined as the dose most closely associated with a toxicity rate of 0.20, and toxicity defined as any grade 3 or 4 toxicity (based on Common Terminology Criteria (CTC) version 3.0 except fatigue. Participants underwent clinical evaluation every 3 weeks (one cycle) and radiologic evaluations every 6 weeks. After the second cycle, participants underwent a radiologic evaluation using the same imaging technique used at initial evaluation (ie, computed tomography or magnetic resonance imaging)."|Following two 3 week cycles of therapy|At MDACC, sixteen participants total treated at 10 mg (dose level 1) in the Phase I portion of the study with the remainder thirty-four registered in Phase II. At DFCI/BIDMC, the first three participants were included in the Phase I portion of the study, the remaining four of seven registered were in Phase II.||mg|||Number
157172|NCT00317642|Secondary|Participants With Adverse Events (CSR 7-April-11)|"Number of participants with treatment emergent adverse events (TEAEs) or death due to related AE. Related AEs for the combination arm can be related to either clofarabine or cytarabine.~Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life Threatening AE, Grade 5 = Death"|Day 1 up to a maximum of 4 years (includes up to a maximum of 3 cycles of therapy plus 45 days follow up. Related AEs are followed to resolution.)|Safety Set - Participants in the Full Analysis Set (FAS) who received at least 1 dose of study drug.||participants|||Number
157173|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment – Overall and by Randomized Strata (CSR 9-July-12)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, that is the strata include the IVRS mistakes.||percentage of participants|||Number
157174|NCT00317642|Secondary|Four-Month Event-free Survival Per IRRP Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Four-month event-free survival (EFS) was defined as achieving an EFS of at least 122 days, where EFS is defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) to Day 122|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||percentage of participants|||Number
157175|NCT00317642|Secondary|Event-free Survival by IRRP Assessment – Overall and by Randomized Strata (CSR 9-July-12)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
157176|NCT00317642|Primary|Overall Survival - Overall and by Randomized Strata (CSR 9-July-12)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 randomized strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS) - composed of all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
157177|NCT00317642|Secondary|Event-free Survival by IRRP Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Event-free survival (EFS) was defined as the time from randomization to the date of treatment failure, first disease recurrence (for participants who achieved remission), or death due to any cause, whichever occurred first.~Treatment Failure - ≥5% leukemic blasts by bone marrow exam, with no evidence of hematologic response (ie, <30% decrease in % leukemic blasts).~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||months||95% Confidence Interval|Median
157178|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Randomized Strata (CSR 9-July-12)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.~See Outcome #3 for definition of CR and CRi.~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
157179|NCT00317642|Secondary|Disease-free Survival by IRRP Assessment - Overall and by Calculated Strata (CSR 7-April-11)|"Disease-free survival was defined as the time from first complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) until the date of first objective documentation of disease recurrence or death due to any cause, whichever occurred first.~See Outcome #3 for definition of CR and CRi.~Disease recurrence - reappearance of leukemic blasts in the peripheral blood, confirmed by ≥5% blasts in the bone marrow, and reappearance or development of pathologically proven extramedullary disease."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.||months||95% Confidence Interval|Median
157180|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Randomized Strata (CSR 9-July-12)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are as randomized by the IVRS, therefore strata include the IVRS mistakes.||months||95% Confidence Interval|Median
157181|NCT00317642|Secondary|Duration of Remission (DOR) Per IRRP Assessment-Overall and by Calculated Strata (CSR 7-April-11)|"DOR was defined as the time from first CR or CRi to the date of first objective documentation of disease recurrence, initiation of alternative antileukemic therapy [including hematopoietic stem cell transplant] while in remission, or death due to any cause, whichever occurred first.~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 to approximately 4 years|Participants in the FAS who achieved OR (CR + CRi). Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes.||months||95% Confidence Interval|Median
157182|NCT00317642|Secondary|Best Response Per Independent Response Review Panel (IRRP) Assessment – Overall and by Calculated Strata (CSR 7-April-11)|"Percentage of participants whose best response was assessed by the IRRP as complete remission (CR) or complete remission with incomplete peripheral blood count recovery (CRi) using the revised International Working Group for Response Criteria (Cheson 2003).~CR is defined on morphologic criteria at a single response assessment:~a bone marrow aspirate or biopsy of <5% blasts, with evidence of normal hematopoiesis;~absence of Auer rods in the blasts that are present;~absence of extramedullary disease;~absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping;~only rare evidence of circulating blasts. If present, evidence of a regenerating bone marrow;~recovery of peripheral counts (platelets ≥100*10^9/L and absolute neutrophil count (ANC) ≥1.0*10^9/L).~CRi met all criteria for CR except for either residual neutropenia (ANC <1.0*10^9/L) or thrombocytopenia (platelet count <100*10^9/L)."|Day 12 up to approximately 6 months|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||percentage of participants|||Number
157183|NCT00317642|Primary|Overall Survival – Overall and by Calculated Strata (CSR 7-April-11)|Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.|Day 1 (randomization) up to approximately 4 years|Full Analysis Set (FAS)-all randomized participants whose baseline AML diagnosis was centrally confirmed. Strata are calculated according to duration of the first remission based on case report forms (CRF) data and do not include the IVRS mistakes. One participant's strata (placebo group) could not be calculated so the participant was excluded.||months||95% Confidence Interval|Median
157184|NCT00317239|Primary|Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL||anytime during the study|Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73²||participants|||Number
157185|NCT00317226|Primary|Incidence of Treatment-emergent Adverse Events||44 week study duration|||each event|||Number
157186|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months|||Inhalations||Standard Error|Least Squares Mean
157187|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Day|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months|||Scores on a scale||Standard Error|Least Squares Mean
157188|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Night|Participants must have both baseline and follow up measure to be included in analysis|Baseline to 6 months|||Scores on a scale||Standard Error|Least Squares Mean
157189|NCT00317044|Secondary|Number of Severe Adverse Events||Up to 6 months|||Events|||Number
157190|NCT00317044|Secondary|Change in Symptoms of GERD as Measured by Reflux Disease Questionnaire (RDQ) From Randomization (Visit 3) to Visit 7|The RDQ questionnaire is used to assess six GI symptoms during the previous week (a burning feeling behind the breastbone, pain behind the breastbone, a burning feeling in the centre of the stomach, pain in the centre of the stomach, an acid taste in the mouth, unpleasant movement of material upwards from the stomach). Each symptom is given a frequency score on a six-point scale (from 0=did not have to 5=daily) and an intensity score on a six-point scale (from 0=did not have to 5=severe). Three domain scores are calculated by forming averages of the frequency and intensity scores of selected symptoms (heartburn: the first two symptoms; dyspepsia: the next two symptoms; regurgitation: the last two symptoms). The overall GERD score is calculated as the average of the hearburn and dyspepsia domain scores. The GERD score can thus range from 0 to 5.|Randomization (Visit 3) to Visit 7|||Scores on a scale||Standard Error|Least Squares Mean
157191|NCT00317044|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S)) Scores From Randomization (Visit 3) to Visit 7|The Asthma Quality of Life Questionnaire, Standardized Version (AQLQ(S))has been developed by and includes 32 questions in 4 domains: activity limitation, symptoms, emotional function, and exposure to environmental stimuli. It is used to measure the physical and emotional impact of the disease in the selected areas of life. Participants must have both baseline and follow up measure to be included in analysis.AQLQ(S) score based on a 7-point scale that ranged from 1 (worst quality of life) to 7 (best quality of life).|From randomization (Visit 3) to Visit 7|||Scores on a scale||Standard Error|Least Squares Mean
157192|NCT00317044|Secondary|Number of Patients With Severe Asthma Exacerbations.||Up to 6 months|||Participants|||Number
157193|NCT00317044|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Randomization to Treatment Period.|Description: Changes in forced expiratory volume in 1 second (FEV1) from randomization (Visit 3) to the treatment period considered as mean value at Visits 4-7. Participants must have both baseline and follow up measure to be included in analysis.|From randomization (Visit 3) to visit 7.|||Liters||Standard Error|Least Squares Mean
157194|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Percentage of Nights With Awakening(s) Due to Asthma|Change in percentage of nights with night-time awakening(s) due to asthma from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis.|Baseline to 6 months|||Percent of nights||Standard Error|Least Squares Mean
157195|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Number of Inhalations of Short-acting β2-agonists (SABAs) - Total From Baseline to 6 Months|This is the change in the average number of inhalations from baseline to the end of the study (6 months). Participants must have both baseline and follow up measure to be included in analysis. Treatment mean calculated using the entire treatment period.|Baseline to 6 months|||Inhalations||Standard Error|Least Squares Mean
157196|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Asthma Symptom Score - Total|Participants must have both baseline and flow up measure to be included in analysis. Each morning and evening, the patient will be asked to record his/her asthma symptoms (sx) in the diary. The asthma sx scores during night- and daytime will be assessed by the patient according to the following scoring system: 0 = no asthma sx; 1 = you are aware of your asthma sx but can easily tolerate the sx; 2 = your asthma sx are causing you enough discomfort to cause problems with normal activities (or with sleep); 3 = you are unable to do your normal activities (or sleep) because of your asthma. The total symptom score is the sum of the night- and daytime scores.|Baseline to 6 months|||Scores on a scale||Standard Error|Least Squares Mean
157197|NCT00317044|Secondary|Changes in Average Value From Baseline to Treatment Period in Evening Peak Expiratory Flow (ePEF (L/Minute))|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. No dispersion measure available.|Baseline to 6 months|||L/minute||Standard Error|Least Squares Mean
157198|NCT00317044|Primary|Mean Change in Morning Peak Expiratory Flow (mPEF (L/Minute)) From Baseline (Mean of the Last 7 Days in the run-in Period) to Treatment Period (Mean of All Available Data During the Treatment Period).|Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.|Baseline to 6 months|||L/minute||Standard Error|Least Squares Mean
157199|NCT00316914|Secondary|Change From Baseline in Quality of Life (QOL) at One Month|Quality of Life (QOL) were measured using the Symptom Experience Diary and supplemental quality of life questions. Item score range: 0 (no symptom) to 10 (worst symptom). The score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.||Units on a scale||Standard Deviation|Mean
157200|NCT00316914|Secondary|Change From Baseline in Fatigue Score at One Month|Fatigue was measured by Brief Fatigue Inventory in the scale of 0 (no fatigue) to 10 (fatigue as bad as you can imagine). The item score was reversed and transformed into 0 (low quality of life (QOL)) to 100 (best QOL) scale for analysis. Change: score at one month minus score at baseline.|Baseline and One month|Includes all patients with at least one assessment after baseline.||units on a scale||Standard Deviation|Mean
157201|NCT00316914|Secondary|Percentage of Patients Experiencing Impact on Activities of Daily Living (ADL)|Activities of daily living were measured using the Symptom Experience Diary and supplemental quality of life questions. The questionnaires' items were in the scale of 0 (no symptom) to 10 (worst symptom).|127 days|Data was collected but not analyzed for this outcome.|||||
157202|NCT00316914|Secondary|Incidence of Calcium Magnesium (CaMg)-Induced Adverse Event|Adverse Events were measured using CTCAE V3.0.|127 days|Analyses of adverse events includes all patients. Adverse event data is not available on one patient in Placebo arm, which leads to the total of 51 in Placebo arm for analysis.||Percentage of Participants|||Number
157203|NCT00316914|Secondary|Percentage of Patients With Acute Neuropathic Adverse Event|Acute neuropathic toxicities were measured using the Symptom Experience Diary and supplemental quality of life questions in the scale of 0 (no symptom) to 10 (worst symptom). The item score was reversed and transformed into 0 (low QOL) to 100 (best QOL) scale for analysis. Any score greater than 0 was considered having acute neuropathy.|127 days|Includes all patients that reported at least one value after baseline.||Percentage of participants|||Number
157204|NCT00316914|Secondary|Average Duration of Oxaliplatin-containing Treatment||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.|||||
157205|NCT00316914|Secondary|Average Cumulative Oxaliplatin Dose||127 days|Because of the early closure of this trial, no reliable data were available for this outcome.|||||
157206|NCT00316914|Secondary|Percentage of Patients Discontinuing Therapy for Chronic Neurotoxicity|Neurotoxicity were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.||Percentage of Participants|||Number
157207|NCT00316914|Secondary|Average Duration of Chronic Neuropathic Toxicity|Neuropathic adverse events were assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.||days||95% Confidence Interval|Median
157208|NCT00316914|Secondary|Time to Onset of Grade 3+ Chronic Neurotoxicity|Neurotoxicity was assessed by CTCAE v3.0.|127 days|Includes all patients that reported at least one value after baseline.||Days||95% Confidence Interval|Median
157209|NCT00316914|Secondary|Time to Onset of Grade 2+ Chronic Neurotoxicity|Neurotoxicity were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|127 days|Includes all patients that reported at least one value after baseline.||Days||95% Confidence Interval|Median
157210|NCT00316914|Primary|Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event|Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory losses that are disabling (Grade 4)|127 days|Efficacy analyses use all patients that reported at least one value after baseline.||Percentage of participants|||Number
157211|NCT00316888|Secondary|3-year Colostomy-free Survival Rate|Colostomy-free survival was defined as time from registration until time of colostomy or death without colostomy, censoring cases without colostomy at the data of last disease assessment documenting the patient was free of colostomy. Kaplan-Meier method was used to estimate the 3-year colostomy-free survival rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients who did not have permanent colostomy at study entry||proportion of participants||95% Confidence Interval|Number
157212|NCT00316888|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s).|Tumor assessments were made at baseline, within 4 weeks of the completion of protocol treatment, then every 6 months if patient was 1-4 years from registration, yearly if patient was 5-10 years from registration until progression/relapse using the RECIST|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
157213|NCT00316888|Secondary|3-year Progression-free Survival Rate|Progression-free survival (PFS) was defined as time from registration to disease progression, relapse or death (whichever occurred first), censoring cases without PFS events at the date of last disease assessment documenting the patient was free of progression/relapse. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the 3-year PFS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
157214|NCT00316888|Secondary|3-year Overall Survival Rate|Overall survival (OS) is defined as time from registration to death from any cause. Patients alive are censored at the last contact date. Kaplan-Meier method was used to estimate the 3-year OS rate.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
157215|NCT00316888|Primary|Local Failure Rate at 3 Years|Local failure was defined as progression/relapse of disease in the anal canal and/or regional organs and/or regional lymph nodes after completion of protocol therapy, or progression during protocol therapy. Lost to follow-up and death (regardless of cause of death) prior to 3 years were also considered as local failures. For the calculation of local failure rate at 3 years, patients were classified into two groups (ie, coded as binary variable): failure (patients with local failure events prior to 3 years) vs. no failure (patients who still alive and had no local failure at 3 years). The binomial proportion and its exact two-sided 80% confidence interval (CI) were used to estimate it.|assessed every 3 months for patients within 2 years of registration, then every 6 months for patients in year 3|eligible and treated patients||proportion of participants||80% Confidence Interval|Number
157216|NCT00316719|Secondary|Rate of Emergence of Resistant Virus at Week 52|Participants with resistant mutation at Week 52. LAM resistant mutation (enzyme-linked mini-sequencing assay): rtM204I/V; ADV resistant mutation (direct sequencing assay): rtN236T or rtA181T/V in HBV DNA ; rt: reverse transcriptase gene|Week 52|PPS||Percentage of participants|||Number
157217|NCT00316719|Secondary|Time to Onset of ALT Normalization|Time to onset of ALT normalization was summarized using the Kaplan-Meier method.|From Baseline to Week 52|PPS: Participants with abnormal ALT value (>ULN) at baseline||Week 52||95% Confidence Interval|Median
157218|NCT00316719|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52|ALT normalization was defined as an ALT value that was in the normal range (<= 45IU/L; upper limit of normal [ULN]) at Week 52 of the participants whose ALT values were abnormal (>45IU/L) at baseline|Week 52|PPS: Participants with an abnormal ALT value (>ULN) at baseline||Percentage of participants|||Number
157219|NCT00316719|Secondary|Mean Alanine Aminotransferase (ALT) Level at Week 52|Summary statistics were displayed for serum ALT.|Week 52|PPS||Units per Liter||Standard Deviation|Mean
157220|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) and positive for anti-Hepatitis B s antibody (HBsAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg and negative for HBsAb at baseline||percentage of participants|||Number
157221|NCT00316719|Secondary|Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52|Participants with loss of Hepatitis B s antigen (HBsAg) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBsAg at baseline||percentage of participants|||Number
157222|NCT00316719|Secondary|Time to Onset of HBeAg/Ab Seroconversion|Time to onset of HBeAg/Ab seroconversion in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52||||||
157223|NCT00316719|Secondary|Time to Onset of HBeAg Loss|Time to onset with loss of HBeAg in serum collected by blood draw was summarized using the Kaplan-Meier method.: CLIA method. Regarding the Measured Values, the median time to onset and its lower limit and its upper limit for all groups are non-estimable because they are not observed until the end of the study.|From Baseline to Week 52||||||
157224|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) and positive for anti-Hepatitis B e antibody (HBeAb) in serum collected by blood draw: CLIA method|Week 52|PPS: participants who were positive for HBeAg and negative for HBeAb at baseline||Percentage of participants|||Number
157225|NCT00316719|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52|Participants with loss of Hepatitis B e antigen (HBeAg) in serum collected by blood draw: Cheminoluminescent Immuno Assay (CLIA) method|Week 52|PPS: participants who were positive for HBeAg at baseline||percentage of participants|||Number
157226|NCT00316719|Secondary|Time to Onset of HBV DNA Loss (< 400 Copies/mL)|Time to onset of an HBV DNA level in serum of less than 400 copies/mL was summarized using the Kaplan-Meier method. Regarding the Measured Values, the median time to onset and its upper limit for the ADV group and the upper limit of the median time to onset for the LAM group are non-estimable because they are not observed until the end of the study. The lower limit of the median time to onset for the ADV and LAM groups are 36.0 and 20.0, respectively. The median time to onset for the LAM group is 28.0|From Baseline to Week 52||||||
157227|NCT00316719|Secondary|Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52|The percentages of participants with an HBV DNA level in serum of less than 400 copies/mL, which is the lower limit of detection (HBV DNA loss) at Week 52|Week 52|PPS||Percentage of participants|||Number
157228|NCT00316719|Primary|Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52|Change from baseline was the difference of the HBV DNA copy numbers (log10) in serum collected by blood draw between baseline and Week 52|Baseline and Week 52|Per Protocol Set (PPS): participants in the Full Analysis Set (all subjects who entered the study, received at least one dose of investigational product, and had at least one efficacy assessment after the treatment initiation) population with no major protocol violations||log10 copies/mL||Standard Deviation|Mean
157229|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up|"Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 24 to Month 48|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.||Subjects|||Number
157243|NCT00316693|Secondary|Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value|Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.|At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.||Subjects|||Number
157230|NCT00316706|Secondary|Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes."|From Month 18 to Month 24|Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point.||Subjects|||Number
157231|NCT00316706|Secondary|Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Month 36 and 48|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.||EL.U/mL||95% Confidence Interval|Geometric Mean
157232|NCT00316706|Secondary|Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up|Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.|At Months 18 and 24|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point.||EL.U/mL||95% Confidence Interval|Geometric Mean
157233|NCT00316706|Primary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At 18, 24, 36 and 48 months|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point.||EL.U/mL||95% Confidence Interval|Geometric Mean
157234|NCT00316693|Secondary|Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples|"Abnormalities in concentrations (expressed as milligrams per deciliter [mg/dL]) are presented categorical as follows:~Protein: <10 (-)*; 10-25 (+-)*; 25-85 (+); 85-250 (2+); 250-800 (3+).~Glucose: <30 (-)*; 30-60 (+-)*; 60-125 (+); 125-250 (2+); 250-750 (3+).~Urobilinogen: <1.5 (+-)*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+).~Bilirubin: <0.35 (-)*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+).~Occult blood: <0.015 (-)*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); >0.75 (3+).~Ketone body: <2.5 (-)*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+).~Normal ranges indicated by asterix*."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated cohort.||Subjects|||Number
157235|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters|"Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined.~Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH)."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
157236|NCT00316693|Secondary|Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters|"Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count.~Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined."|At Month 0 and Month 7|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
157237|NCT00316693|Secondary|Outcome of Any Reported Pregnancies|Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.|Throughout the study period (up to Month 24)|Analysis was performed on those subjects reporting pregnancy during the study period.||Subjects|||Number
157238|NCT00316693|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
157239|NCT00316693|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (up to Month 24)|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
157240|NCT00316693|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
157241|NCT00316693|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.|Within 7 days after each and any vaccination|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.||Subjects|||Number
157242|NCT00316693|Secondary|Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|At Months 0, 6, 7, 12, 18 and 24|||EL.U/mL||95% Confidence Interval|Geometric Mean
157323|NCT00316017|Secondary|Greater Than 10 Units PRBC in First 24 Hours|This is the total number of subjects who received greater than 10 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours|||participants|||Number
157244|NCT00316693|Secondary|Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157245|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type|"Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157246|NCT00316693|Secondary|Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6].~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157247|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types|"Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6.~Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68."|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157248|NCT00316693|Secondary|Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection|Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157249|NCT00316693|Secondary|Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection|Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157250|NCT00316693|Secondary|Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.|Up to Month 24|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157251|NCT00316693|Primary|Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)|Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6].|Throughout the study period (up to Month 24)|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.||Subjects|||Number
157252|NCT00316355|Primary|Treatment-related Total Cost Estimates|total estimated costs calculated based upon the fixed-dose schedule|Posttreatment|Treatment completers||dollars||Standard Deviation|Mean
157253|NCT00316355|Primary|Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score|The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score was used as the outcome measure. The Y-BOCS is a clinician-rated scale assessing obsession (5 items) and compulsion (5 items) symptom severity on a 0 to 4 scale. All 10 items are added for the total score, with total scores ranging from 0 to 40, and higher numbers indicating more severe symptoms.|Pretreatment, Posttreatment, and 3-month follow-up|Randomized participants||units on a scale||Standard Deviation|Mean
157254|NCT00316303|Primary|Referral for Medical Care|For participants infected with hepatitis C, their self-report of being referred for medical care.|6 Months|||participants|||Number
157255|NCT00316303|Primary|Tested for HIV|Participant self-report of being tested for HIV|6 Months|||participants|||Number
157256|NCT00316303|Primary|Tested for Hepatitis B|Participant self-report of being tested for hepatitis B|6 Months|||participants|||Number
157257|NCT00316303|Primary|Tested for Hepatitis C|Participant self-report of being tested for hepatitis C|6 Months|||participants|||Number
157258|NCT00316303|Primary|Change in Immunization Status|Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.|Measured at 6 Months relative to Baseline|||participants|||Number
157259|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment|In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence.|12 weeks in Phase 2 period (i.e., 24 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.||participants|||Number
157260|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks|||participants|||Number
157261|NCT00316277|Secondary|The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1|As a planned secondary analysis, we examined the impact of the two phase 1 stratification variables on the primary outcome.|12 weeks|Participants randomized to Phase 1 were stratified by two variables: current chronic pain and lifetime heroin use.||participants|||Number
157262|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks|||participants|||Number
157263|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition|"As a planned secondary analysis, we examined the impact of the two Phase 1 stratification variables on the primary end points. Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."|12 weeks|379 identified as having chronic pain at baseline in Phase 1.||participants|||Number
157264|NCT00316277|Secondary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up|A planned secondary outcome, successful outcome at week 24, that is, 8 weeks after completion of buprenorphine-naloxone taper, was defined the same as at week 12 of Phase 2, that is abstinent from opioids during week 24 and at least 2 of the previous 3 weeks.|24 weeks in Phase 2 period (i.e., 36 weeks into the study)|360 participants randomized to Phase 2 were included in the analysis.||participants|||Number
157265|NCT00316277|Primary|The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1|In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.|12 weeks|653 study participants randomized to Phase 1 were included in analysis.||participants|||Number
157266|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Any Time|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157267|NCT00316264|Secondary|The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final pose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157268|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 150|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157269|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 60|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157270|NCT00316264|Secondary|The Immunogenicity of Palivizumab at Day 0|Number of subjects with detected anti-palivizumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157271|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Any Time|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|At any time|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157324|NCT00316017|Secondary|1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received 1 to 9 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days|||participants|||Number
157272|NCT00316264|Secondary|The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|120 - 150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157273|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 150|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157274|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 60|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157275|NCT00316264|Secondary|The Immunogenicity of Motavizumab at Day 0|Number of subjects with detected anti-motavivumab antibodies are reported; defined as a titer with a dilution value of greater than or equal to 1:10.|Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||participants with detected antibody|||Number
157276|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157277|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157278|NCT00316264|Secondary|The Trough Serum Concentrations of Palivizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157279|NCT00316264|Secondary|The Serum Concentrations of Palivizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157280|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose||120-150 days post final dose|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157281|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 150||Day 150|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157282|NCT00316264|Secondary|The Trough Serum Concentrations of Motavizumab at Day 60||Day 60|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157283|NCT00316264|Secondary|The Serum Concentrations of Motavizumab at Day 0||Day 0|The PK/immunogenicity population included all subjects in the safety population who did not receive commercial Synagis within 120 days prior to Study Day 0. Additional subjects were excluded from individual time point summaries of the analyses if the correct number of study drug doses were not received prior to the corresponding time point.||μg/mL||Standard Deviation|Mean
157284|NCT00316264|Primary|Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs.|Serum chemistry samples were collected at Day 0, Day 60, and Day 150. Values representing changes in severity according to the AE grading table were recorded as AEs.|Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.||participants|||Number
157285|NCT00316264|Primary|Number of Subjects Reporting Adverse Events (AEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.||participants|||Number
157286|NCT00316264|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||Day 0 - Day 150|The safety population included all randomized subjects who received study drug and had any safety follow-up.||participants|||Number
157325|NCT00316017|Secondary|1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received 1 to 9 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital|||participants|||Number
157287|NCT00316225|Primary|Overview of Adverse Events|Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
157288|NCT00316225|Secondary|Discontinuations Due to Adverse Events|Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
157289|NCT00316225|Other Pre-specified|Overall Tumor Response|"Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments.~CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions.~PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions.~SD (stable disease) = small changes that do not meet above criteria."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
157290|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics: Volume of Distribution|Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.||Liters (L)||Standard Deviation|Mean
157291|NCT00316225|Secondary|Pemetrexed Population Pharmacokinetics (PK): Clearance|Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.|Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion|Patients who received at least one dose of study drug.||milliliter per minute (mL/min)||Standard Deviation|Mean
157292|NCT00316225|Secondary|Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities|"Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening.~NOS = Not otherwise specified."|baseline, up to 18 weeks|Patients who received at least one dose of study drug.||participants|||Number
157293|NCT00316199|Secondary|Overall Survival Probability|Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability.|baseline to date of death from any cause|All enrolled participants. Fifty-two participants were censored.||percent|||Number
157294|NCT00316199|Secondary|Duration of Response|Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.|time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|Enrolled participants who were considered responders (had either a complete response or partial response).||months||95% Confidence Interval|Median
157295|NCT00316199|Secondary|Progression-Free Survival|Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.|baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants. Forty-two participants were censored.||months||95% Confidence Interval|Median
157296|NCT00316199|Secondary|Time to Treatment Failure|Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.|baseline to stopping treatment|All enrolled participants. Time to treatment failure for participants who are still participating in the study without treatment failure at the time of analysis will be treated as censored at thte date of the last tumor assessment (3 participants censored).||months||95% Confidence Interval|Median
157297|NCT00316199|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)|All enrolled participants diagnosed with metastatic breast cancer, had measurable disease at baseline, and received at least one dose of study drug. Two participants were excluded from analysis because they received chemotherapy for locally advanced/metastatic breast cancer within 6 months prior to enrollment.||participants|||Number
157326|NCT00316017|Secondary|1-9 Units PRBC and Died in Field or ED|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) among the patients who died in the field or the ED.|From the time dispatch received 911 call to the time of death in the field or ED|||participants|||Number
157298|NCT00316186|Secondary|Grade 4 (Life-threatening or Disabling) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)||participants|||Number
157299|NCT00316186|Secondary|Grade 3 (Severe) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT population (i.e., participants who had at least one dose of study medication)||participants|||Number
157300|NCT00316186|Secondary|Grade 2 (Moderate) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity|ITT Population (i.e., participants who had at least one dose of study medication)||participants|||Number
157301|NCT00316186|Secondary|Grade 1 (Mild) Hematological Toxicities|Hematology evaluation included hemoglobin, hematocrit, red blood cell count, white blood cell with differential and platelet count. Differential included neutrophils, bands, lymphocytes, monocytes, eosinophils, and basophils. The intensity of each hematological toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEs). Hematological toxicities are summarized by Common Terminology Criteria (CTC) V3.0 Maximum Toxicity Grade.|Week 1 through Endpoint (variable based on disease progression or toxicity)|ITT Population (i.e., participants who had at least one dose of study medication)||participants|||Number
157302|NCT00316186|Secondary|Overall Survival, Calculated as the Number of Subjects Who Died From the Start of Treatment Until Follow-up|Overall survival is defined as the time from the start of treatment until death due to any cause. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage of the study was not conducted.|Week 1 up to maximum of Day 519||||||
157303|NCT00316186|Secondary|Time to Progression|Time to progression is defined as the time from the start of treatment until the first documented sign of disease progression or death due to any cause, if sooner. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From start of treatment to disease progression/death||||||
157304|NCT00316186|Secondary|Response Duration|Duration of response is calculated as the time from first documented partial or complete response until first documented sign of disease progression or death. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available.|From time of partial or complete response to disease progression/death||||||
157305|NCT00316186|Secondary|Time to Response|Time to response is calculated as the time from the start of treatment until first documented evidence of partial or complete response. The study was terminated after the dose-finding run-in component was completed because of slow recruitment and acknowledgement of a competing Phase II study. Data not available, as the activity stage was not done.|From start of treatment to evidence of partial or complete response||||||
157306|NCT00316186|Primary|Overall Response Rate, as Determined by Radiologic Evaluation (Utilizing the World Health Organization [WHO] Criteria), Calculated as the Number of Participants With the Indicated Response|The categories of tumor response were: complete response (complete disappearance of all known lesions determined by 2 measurements not less than 4 weeks apart), partial response (>50% decrease in measurable lesions for at least 4 weeks with no appearance of new lesions), stable disease (no change in tumor size for at least 8 weeks), progressive disease (>25% increase in measurements of lesions or appearance of new lesions), and not evaluable. The overall response rate was determined using a scan performed within the first 30 days of the first response.|Baseline until up to Day 169|ITT (Intent to Treat): participants that received at least one dose of study drug||Participants|||Number
157307|NCT00316173|Secondary|Time to Disease Progression|"Although “Time to Disease Progression” was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of “Progression-free Survival”. As such, “Progression-free Survival” was measured, not “Time to Disease Progression”. See the outcome measure entitled Progression-free Survival for data pertaining to time to disease progression."|From start of treatment to disease progression/death|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug|||||
157308|NCT00316173|Secondary|The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)|CA-125 is a “tumor marker”, found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline.|Baseline to end of study (up to 54.7 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||participants|||Number
157309|NCT00316173|Secondary|Number of Participants Who Died From the Start of Treatment to Follow-up|"The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was censored."|From start of treatment to death (up to 110.4 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||participants|||Number
157451|NCT00315146|Secondary|Lean Body Mass||Baseline visit (pre intervention) and 4month follow up (post intervention)|||kg||95% Confidence Interval|Least Squares Mean
157310|NCT00316173|Secondary|Progression-free Survival|"Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored. Although “Time to Disease Progression” was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of “PFS”. As such, “PFS” was measured, not “Time to Disease Progression”."|From start of treatment to disease progression/death (up to 67.7 weeks)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||weeks||95% Confidence Interval|Median
157311|NCT00316173|Primary|Number of Participants With the Indicated Response|Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions).|From start of treatment to evidence of CR or PR (up to 39.3 weeks).|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug||participants|||Number
157312|NCT00316173|Secondary|Duration of Response|"Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was censored."|From time of PR or CR to disease progression/death (up to 56.0 weeks)|All participants who showed a tumor response (CR or PR).||weeks||95% Confidence Interval|Median
157313|NCT00316173|Secondary|Time to Response|Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; >50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions).|From start of treatment to evidence of PR or CR (up to 39.3 weeks)|All participants who showed a tumor response (CR or PR).||weeks||95% Confidence Interval|Median
157314|NCT00316121|Primary|Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)|Success is bridging bone, slip of study level versus adjacent levels less than 3 millimeters, angulation less than 5 degrees, 15 point increase in Oswestry Disability Index (ODI) (how back/leg trouble affects activities of daily living), no new problems in motor strength in legs, presence/absence of pain on leg raise, sensation intact on thigh/leg/foot reflexes of the knees/ankles, no permanent/serious complications, no revision/removal/reoperation/supplemental fixation. The ODI is on a 6 point scale from 0 (no pain/no impact on duties) to 5 (worst pain ever/unable to perform duties).|24 months|Safety Population:All subjects treated. Full Analysis Set(FAS):Subset of Safety Pop. w/follow up. All effectiveness measures were to be assessed on FAS. FAS is intent-to-treat pop. Per Protocol: Subset of FAS who complete study, treated as randomized w/no major protocol deviations. All analyses were to be on this subset.||Subjects|||Number
157315|NCT00316082|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
157316|NCT00316082|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
157317|NCT00316082|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
157318|NCT00316082|Secondary|Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||percent||Standard Error|Mean
157319|NCT00316082|Primary|Change From Baseline in Hemoglobin A1 (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.||percent||Standard Error|Mean
157320|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received the 911 call to 28 days|||participants|||Number
157321|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received greater than 10 units of packed red blood cells (PRBC).|The first 6 hours from the time of admission to the hospital|||participants|||Number
157322|NCT00316017|Secondary|Greater Than 10 Units PRBC and Died in Field or ED|This is the total number of subjects who died in the field or the ED among the patients who received greater than 10 units of packed red blood cells (PRBC).|From the time dispatch received 911 call to the time of death in the field or ED|||participants|||Number
157327|NCT00316017|Secondary|1-9 Units PRBC in First 24 Hours|This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours|||participants|||Number
157328|NCT00316017|Secondary|Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call|This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received no units of PRBC.|From the time dispatch received the 911 call to 28 days|||participants|||Number
157329|NCT00316017|Secondary|Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital|This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received no blood products.|The first 6 hours from the time of admission to the hospital|||participants|||Number
157330|NCT00316017|Secondary|Zero Units PRBC and Died in Field or Emergency Department (ED)|This is the total number of subjects who died in the field or the ED from the set of subjects who received no blood products.|From the time dispatch received 911 call to the time of death in the field or ED|||participants|||Number
157331|NCT00316017|Secondary|Zero Units PRBC in First 24 Hours|This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.|From the time dispatch received the 911 call to the end of the first 24 hours|||participants|||Number
157332|NCT00316017|Secondary|Survival at Hospital Discharge|Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.|Duration of hospital stay through to discharge|||participants|||Number
157333|NCT00316017|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|First 28 days from the time of 911 call|||days||Standard Deviation|Mean
157334|NCT00316017|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|First 28 days from the time of 911 call|||days||Standard Deviation|Mean
157335|NCT00316017|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day O through day 28 that the patient did not require mechanical ventilation"|Duration of hospital stay through day 28|||days||Standard Deviation|Mean
157336|NCT00316017|Secondary|Total Fluids First 24 Hours|The total amount of IV fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of 911 call|First 24 hours from the time of of 911 call|||Liters||Standard Deviation|Mean
157337|NCT00316017|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The numbers of units of packed red blood cells transfused in the first 24 hours|First 24 hours from the time of 911 call|||units of packed red blood cells||Standard Deviation|Mean
157338|NCT00316017|Secondary|Presence of Nosocomial Infection Through Day 28|Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection|Within 28 days of injury, while hospitalized|||participants|||Number
157339|NCT00316017|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28|"Multiple Organ Dysfunction Score is described as:~Six organ systems were chosen, and a score of 0-4 allotted for each organ according to function (0 being normal function through to 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) in each 24-hour period is taken for calculation of the aggregate score."|28 days from time of ED arrival|||Scores on a scale||Standard Deviation|Mean
157340|NCT00316017|Secondary|Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28|Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28|28 days from time of ED arrival|||participants|||Number
157341|NCT00316017|Primary|28 Day Survival|"The day of episode is counted as Day 0. So for measures using a 28 day period, the maximum value is 29 (i.e. days 0 through 28)."|28 days from time of Emergency Department (ED) arrival|Per protocol, analysis was done on only those subjects who received the study fluid per randomization; this was defined as that the study fluid had been connected to the patient's IV.||participants|||Number
157342|NCT00316004|Secondary|Discharge Disposition|Disposition of patient at the time of discharge from the acute care hospital|Duration of hospital stay|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Participants|||Number
157343|NCT00316004|Secondary|Packed Red Blood Cells (PRBC) First 24 Hours|The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group.|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.||Unit of PRBC||Standard Deviation|Mean
157344|NCT00316004|Secondary|Total Fluids in First 24 Hours|The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call|First 24 hours from the time dispatch received 911 call|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.||Liters||Standard Deviation|Mean
157345|NCT00316004|Secondary|Presence of Nosocomial Infections|Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection|From day of injury to 28 days after injury|"An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. Percentages were based on population at risk.~Row 1 nosocomial infections; Row 2 pneumonia; Row 3 bloodstream infections; Row 4 urinary tract infections; and Row 5 wound infections"||Diagnoses|||Number
157346|NCT00316004|Secondary|Days Alive Out of the Hospital Through Day 28|The number of days the patient is alive and no longer an inpatient in the hospital through day 28|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Days||Standard Deviation|Mean
157347|NCT00316004|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|The number of days the patient is alive and not being cared for in the intensive care unit|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Days||Standard Deviation|Mean
157348|NCT00316004|Secondary|Ventilator-free Days Through Day 28|"The number of days beginning with the day of 911 call counted as Day 0 through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Days||Standard Deviation|Mean
157349|NCT00316004|Secondary|Worst Multiple Organ Dysfunction Score (MODS) Through Day 28|Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24).|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Scores on a scale||Standard Deviation|Mean
157350|NCT00316004|Secondary|Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28|The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg.|From day of injury to 28 days after injury|Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study.||Participants|||Number
157351|NCT00316004|Secondary|Survival at Hospital Discharge up to 6 Months From Date of Injury|The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury.|Date of hospital discharge up to 6 months from date of injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data.||Participants|||Number
157352|NCT00316004|Secondary|28 Day Survival|The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28.|28 days after injury|An analysis of this secondary outcome was done for all participants assigned to each of the three groups who did not refuse or were lost to follow-up prior to discharge.||Participants|||Number
157353|NCT00316004|Secondary|Disability Rating Score (DRS) Categories of Disability|The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
157354|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
157355|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
157452|NCT00315146|Primary|Appendicular Non-bone Lean Mass|Change in Appendicular Non-bone Lean Mass|Baseline visit (pre intervention) and 4month follow up (post intervention)|||kg||95% Confidence Interval|Least Squares Mean
157356|NCT00316004|Secondary|Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis|The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.|6 months after injury|To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.||Participants (with imputed values)|||Number
157357|NCT00316004|Primary|Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis|Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.|6 months after injury|The primary analysis was designed as modified intent-to-treat, with all patients who had fluid connected to intravenous (IV) tubing included regardless of how much fluid was administered. Per the a priori trial design, patients for whom the fluid bag was opened but not connected to the IV were not considered enrolled in the trial.||Participants|||Number
157358|NCT00315939|Primary|Frequency of Severe Hypoglycemia|"Severe hypoglycemia (SH) was defined to subjects as blood glucose so low that you could not treat yourself because you were stuporous or unconscious."|1 year (each level lasted 3 months)|"All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using dropout as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown."||episodes/month/person|||Number
157359|NCT00315939|Primary|Hemoglobin A1c||1 year (each level lasted 3 months)|All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using “dropout” as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.||percentage of glycated hemoglobin||Standard Deviation|Mean
157360|NCT00315731|Secondary|Overall Survival|Time to death is defined as the time from the dosimetric dose to the date of death.|Week 7 to Week 260 post treatment|ITT-E Population||months||95% Confidence Interval|Median
157361|NCT00315731|Secondary|Progression-free Survival|Progression-free survival, or time to progression, is defined as the time from the dosimetric dose to the first documented disease progression (PD) or death. PD is defined as a >= 50% increase from nadir in the SPPD for all measurable disease.|Week 7 to Week 260 post treatment|ITT-E Population||months||95% Confidence Interval|Median
157362|NCT00315731|Secondary|Duration of Response|Duration of response is defined as the time from first documented response (CR, CRu, or PR) until disease progression.|Week 7 to Week 260 post treatment|ITT-E Population. Only participants who had a response (CR, CRu, or PR) were evaluated.||months||95% Confidence Interval|Median
157363|NCT00315731|Secondary|Percentage of Participants Evaluable for Confirmed Response With Complete Response (CR), CR Unconfirmed (CRu), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD)|Evaluation based on the Int'l Workshop to Standardize Response Criteria for non-Hodgkin's Lymphoma (NHL). CR, complete disappearance of all detectable clinical/radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to NHL. CRu, complete response unconfirmed, included complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. PR, >=50% decrease in sum of perpendicular diameters (SPD) of all measurable lesions determined at baseline. SD, less than a PR but not progressive disease (>=50% increase from nadir in SPD for all measurable disease or the appearance of any new lesion that was >=1.4 cm x 1.4 cm by radiographic evaluation or >=1.0 cm by palpation per physical examination).|From Baseline up to 99 Months|ITT-E Population. The individual categories for confirmed CR, confirmed CRu, etc. counts those participants who had their response confirmed by the exact same response, not those who had their response confirmed by a better response (for example, Cru to CR; PR to CR; PR to CRU; etc.).||percentage of participants|||Number
157364|NCT00315731|Secondary|Number of Participants With Expected Distribution of Radioactivity in the Circulatory System Compared With Uptake by Other Organs.|Expected biodistribution (images): most radioactivity (RA) in blood pool, with uptake in normal liver and spleen less than the heart. Later time points, RA in blood pool decrease and uptake in normal liver and spleen decrease. Images may show uptake by the thyroid gland, kidneys, urinary bladder, and lungs. Altered biodistribution: Blood pool not visualized or diffuse, intense uptake in the liver and/or spleen, or uptake suggestive of urinary obstruction, diffuse lung uptake greater than the blood pool|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points.||participants|||Number
157365|NCT00315731|Secondary|Mean Absorbed Dose in the Source Organs and the Target Organs|The radiation absorbed dose to source organs were determined with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software using residence times directly determined by an independent reviewer for kidneys, liver, lungs, spleen, urinary bladder, and total body; the radiation absorbed dose for the remaining target organs was based on a mathematical model used to calculate source organ radiation dose estimates using the same OLINDA/EXM software. OLINDA/EXM is a registered proprietary computer program.|0 to 7 days from dosimetric dose|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).||mGy/MBq||95% Confidence Interval|Mean
157366|NCT00315731|Secondary|Mean Residence Times From Day 0 to Day 7|Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. Assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the total body residence times. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants who were considered evaluable for dosimetric assessment per protocol eligibility criteria and had gamma camera scans from at least 4 time points. Different numbers of participants were analyzed for different organs (represented by n=X, X in the category titles).||hours||95% Confidence Interval|Mean
157367|NCT00315731|Secondary|Maximum Concentration (Cmax) Values|Maximum observed concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after the dose.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID/mL||95% Confidence Interval|Geometric Mean
157368|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to Infinity (Extrapolated)|Ratio and 90% CI for AUC (0 to infinity) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose is given.|0 to infinity h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
157369|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 168 Hours|Ratio and 90% confidence interval for AUC(0-168) after dosimetric dose of fission-derived 131I-tositumomab to historical data from tellurium-derived 131I-tositumomab. AUC measures how much drug is in the blood over time after the dose.|0-168 h from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
157370|NCT00315731|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours|Area under the concentration-time curve from time 0 to 120 hours after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
157371|NCT00315731|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state of 131I-tositumomab. Volume of distribution measures how much the drug spreads through the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||milliliters (ml)||95% Confidence Interval|Geometric Mean
157372|NCT00315731|Primary|Clearance (CL) Values|Clearance of 131I-tositumomab after intravenous administration. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0 to 7 days from dosimetric dose given only once on Day 0|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||milliliters per hour (ml/hr)||95% Confidence Interval|Geometric Mean
157373|NCT00315731|Primary|Terminal Phase Half-life (t½)|The terminal phase half-life of 131 I tositumomab in hours. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||hours||95% Confidence Interval|Geometric Mean
157374|NCT00315731|Primary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed 131I-tositumomab concentration from time zero (end of the dosimetric dose infusion) to 7 days after the end of the infusion. Unit: %ID/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. Cmax is the highest drug concentration in the blood after infusion.|0 to 7 days from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID/mL||95% Confidence Interval|Geometric Mean
157375|NCT00315731|Primary|Area Under the Curve (AUC) at 0 to 120, 0 to 168, and 0 to Infinity Hours|Area under the concentration-time curve for 131I-tositumomab from time 0 to 120, 0 to 168, and time 0 to infinity hours (extrapolated), after the end of the dosimetric dose infusion. Unit: %ID.h/mL, where %ID/mL is the percentage of the injected dose per milliliter blood. AUC measures how much drug is in the system over time after infusion.|0-120, 0-168, and 0-infinity hours from dosimetric dose (given only once on Day 0)|All participants considered as evaluable for pharmacokinetic assessment per protocol criteria.||%ID.h/mL||95% Confidence Interval|Geometric Mean
157376|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
157377|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 2|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase 2 portion of study)|All participants||participants|||Number
157378|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|All phase 2 participants. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
157453|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 12)|Subjects who reported being very satisfied with back care|12 weeks|||participants||95% Confidence Interval|Number
157454|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 8)|Subjects who reported being very satisfied with back care|8 weeks|||participants||95% Confidence Interval|Number
157379|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 2 portion of study)|Phase 2 participants who achieved overall remission. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
157380|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 2|The weeks between start of intervention and remission as assessed by the investigator in Phase 2. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 2 portion of study)|Participants in phase 2 who had an overall remission.||weeks||Standard Deviation|Mean
157381|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 2|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 2 portion of study)|All phase 2 participants||participants|||Number
157382|NCT00315705|Primary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ≥75/ ≥0.75 [x 10^9/L] 2) CR in absence of plt recovery (CRp): plt ≥20 to <75 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 28-56 days (Phase 2 portion of study)|All phase 2 participants||percentage of total participants|||Number
157383|NCT00315705|Secondary|Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1|Overall survival is defined as the time from date of first administration of study interventions until date of death, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants||weeks||95% Confidence Interval|Median
157384|NCT00315705|Secondary|Number of Participants With 4-month Event Free Survival in Phase 1|Number of participants with event-free survival at four months post first dose of therapy. A participant is considered event-free if at month 4 they have not died or had a response assessment confirming a relapse.|4 months (Phase I portion of study)|All participants||participants|||Number
157385|NCT00315705|Secondary|Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1|Event-free survival (EFS) is defined as the time from date of first administration of study interventions until the earliest of the following: date of death or date of first response assessment confirming relapse or date of final response assessment which fails to confirm response, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|All phase 1 participants. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
157386|NCT00315705|Secondary|Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1|Duration of response is the time from the first objective measurement of complete response (CR) or complete response with the absence of total platelet recovery (CRp) to the date of first objective documentation of disease relapse or death due to any cause, plus one day. For summary purposes, results are presented as weeks.|Up to 2 years (Phase 1 portion of study)|Phase 1 participants who achieved overall remission. Data are censored at date of last known follow-up visit.||weeks||95% Confidence Interval|Median
157387|NCT00315705|Secondary|Time to Remission for Participants Who Had a Response in Phase 1|The weeks between start of intervention and remission as assessed by the investigator in Phase 1. Participants who had a complete remission (CR) or complete remission with the absence of total platelet recovery (CRp) are included.|up to 8 weeks (Phase 1 portion of study)|Participants in phase 1 who had an overall remission.||weeks||Standard Deviation|Mean
157388|NCT00315705|Secondary|Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1|Response categories 1) complete remission (CR): without circulating blasts or extramedullary disease, bone marrow (BM) with <5% blasts, and platelet (plt)/ANC recovery: ALL ≥75/ ≥0.75 [x 10^9/L]; AML ≥100/ ≥1.0 [x 10^9/L] 2) CR in absence of plt recovery (CRp): ALL plt ≥20 to <75 x 10^9/L; AML plt ≥20 to <100 x 10^9/L 3) partial remission (PR): no circulating blasts, appearance of normal hematopoietic progenitors, and either a BM with ≥5% and ≤25% blasts with recovery of plts/ANC or a BM with <5% blasts not meeting CR/CRp definition 4) Overall remission (OR): CR+CRp 5) Any response: CR+CRp+PR.|Approximately 2 months (Phase 1 portion of study)|All phase 1 participants||percentage of total participants|||Number
157389|NCT00315705|Secondary|Summary of Participants With Adverse Events (AEs) in Phase 1|Number of participants with AEs that occurred during treatment and follow-up period (45 days after last cycle). Drug-related AEs and SAEs were followed until resolved or mutually agreed by the investigator and Genzyme to discontinue reporting. AEs were classified by the investigator according to severity (graded using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) and relationship to study drug. The severity scale is: > Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death related to AE|Up to 9.5 months (Phase 1 portion of study)|All phase 1 participants||participants|||Number
157390|NCT00315705|Primary|Participants With Dose Limiting Toxicity in Phase 1|The number of participants in each cohort that had dose limiting toxicity is summarized. Toxicities were reviewed by an independent Data Safety Monitoring Board (DSMB) who determined if additional participants should be added to the cohort and the criteria for escalating to the next cohort.|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants||participants|||Number
157455|NCT00315120|Secondary|Satisfaction With Back Care (UST and Sham UST - Week 4)|Subjects who reported being very satisfied with back care|4 weeks|||participants||95% Confidence Interval|Number
157456|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 12)|Subjects who reported being very satisfied with back care|12 weeks|||participants||95% Confidence Interval|Number
157391|NCT00315705|Primary|Maximum Tolerated Dose (MTD) in Phase 1|"The MTD was to be the highest dose level of clofarabine in combination with etoposide and cyclophosphamide that caused <= 1 of 6 participants to experience a dose limiting toxicity (DLT) with the next higher dose level having at least 2 of 3 or 2 of 6 participants experiencing a DLT. The MTD would be used as the recommended phase 2 dose (RP2D). If the MTD could not be determined, then the target dose of clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 as taken by Cohort 5 was to become the RP2D.~The rating scale used is 0 = not the MTD, 1 = the MTD."|Up to Day 42 (Phase 1 portion of study)|All phase 1 participants||units on a scale|||Number
157392|NCT00315614|Secondary|Improvement in or Decreased Progression of Microvascular, Macrovascular and Neuropathic Complications of Diabetes.||for the duration of islet graft function||||||
157393|NCT00315614|Secondary|Elimination or Reduction in the Incidence of Hypoglycemic Coma or Unawareness;||for the duration of islet graft function||||||
157394|NCT00315614|Secondary|CGMS (Continuous Glucose Monitoring System)||for the duration of islet graft function||||||
157395|NCT00315614|Secondary|Mean Glucose Meter Readings,||for the duration of islet graft function||||||
157396|NCT00315614|Secondary|Mean Amplitude of Glycemic Excursions (MAGE),||for the duration of islet graft function||||||
157397|NCT00315614|Secondary|HbA1C (Should be < 6.5%),||for the duration of islet graft function||||||
157398|NCT00315614|Secondary|Improvement in Metabolic Control as Evidenced by Improvement in:||for the duration of islet graft function||||||
157399|NCT00315614|Secondary|Insulin Independence or Reduction in Exogenous Insulin Requirements (Partial Graft Function), as Evidenced by Basal C-peptide Greater Than 0.5 ng/ml Prior to Weaning of Immunosuppression;||for the duration of islet graft function||||||
157400|NCT00315614|Primary|The Induction of Multilineage Chimerism||for the duration of islet graft function||||||
157401|NCT00315614|Primary|A Reduction or Absence of Rejection Episodes||for the duration of islet graft function||||||
157402|NCT00315614|Primary|The Achievement of Persistent Islet Function Following Cessation of Immunosuppression.||for the duration of islet graft function|||participants|||Number
157403|NCT00315458|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.|483 days|The full analysis population consisted of all subjects who were randomized into the double-blind phase and received at least 1 dose of double-blind treatment.||participants|||Number
157404|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.”~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
157405|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
157406|NCT00315445|Post-Hoc|"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.”~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
157407|NCT00315445|Post-Hoc|"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"|"Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)."|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
157457|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 8)|Subjects who reported being very satisfied with back care|8 weeks|||participants||95% Confidence Interval|Number
157408|NCT00315445|Post-Hoc|Sensitivity Analysis: “Pain Right Now” Change From Baseline in the Maintenance Period (Days 21–84), BOCF|Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.” Primary back pain was measured.|Baseline to days 21-84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
157409|NCT00315445|Post-Hoc|Sensitivity Analysis: “Pain on the Average” Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)|Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.|Baseline to days 21 - 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
157410|NCT00315445|Secondary|The Time to Discontinuation Due to Lack of Efficacy|Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure.|Time after dosing to dropout due to lack of efficacy|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn because the informed consent was never obtained and had no efficacy data."||Days||Inter-Quartile Range|Median
157411|NCT00315445|Secondary|Time to Stable Pain Management|"For each subject, time to stable pain management is defined as the first (post-baseline) time during the titration period when his/her diary pain was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the pain on the average (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline)."|Start of study to day 21.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Days||Inter-Quartile Range|Median
157412|NCT00315445|Secondary|Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)|The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157413|NCT00315445|Secondary|Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)|The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0–2 ordinal scale from 0 = “Worse than prestudy medicine” to 2 = “Better than prestudy medicine.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157414|NCT00315445|Secondary|Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)|The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157415|NCT00315445|Secondary|Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)|The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0–3 ordinal scale from 0 = “No response” to 3 = “Marked response.”|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157416|NCT00315445|Secondary|"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Mental Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157417|NCT00315445|Secondary|"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Emotional Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157458|NCT00315120|Secondary|Satisfaction With Back Care (OMT and Sham OMT - Week 4)|Subjects who reported being very satisfied with back care|4 weeks|||participants||95% Confidence Interval|Number
157459|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
157418|NCT00315445|Secondary|"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Social Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157419|NCT00315445|Secondary|"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Vitality is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157420|NCT00315445|Secondary|"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. General Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157421|NCT00315445|Secondary|"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"|"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Bodily Pain is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157422|NCT00315445|Primary|Pain Right Now, Mean Change From Baseline, Days 21–84 (LOCF)|Subjects were asked, “Please rate your pain by circling the one number (0–10) that tells how much pain you have right now.” Subjects rated their answers on a 0–10 ordinal scale from 0 = “No pain” to 10 = “Pain as bad as you can imagine it.” Pain right now is presented as the LSmean [change from baseline] (SE).|Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Least Squares Mean
157423|NCT00315445|Secondary|"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"|"The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. Physical Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157424|NCT00315445|Secondary|"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"|"The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. Physical Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed."|Day 84, or, if applicable, at early termination|"All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained."||Units on a scale||Standard Error|Mean
157425|NCT00315445|Primary|Pain on the Average, Mean Change From Baseline Days 21–84 (Last Observation Carried Forward [LOCF])|Subjects were asked, “Please rate your pain by circling the one number (0–10) that best describes your pain on the average since your last visit.” 0 = no pain and 10 = pain as bad as you can imagine it.|On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.|All 134 subjects randomized and received study drug were included in the intent-to-treat (ITT) and safety analyses. ITT Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from study because the informed consent was never obtained. This subject had no efficacy data but was included the analysis of discontinuation due to lack of efficacy.||Units on a scale||Standard Error|Least Squares Mean
157426|NCT00315341|Primary|Hepatic Safety|"Participants were categorized according liver transaminase (ALT, AST) levels in blood comparing the baseline sample to any and all subsequent samples in the following manner:~A: both ALT and AST started at less than or equal to two times the ULN and remained at two times or less ULN throughout the study~B: either ALT or AST started at less than or equal to 2 x ULN and at any point in study exceeded 2 x ULN~C: Either ALT or AST started > 2 x ULN, decreased (both ALT and AST) to < 2 x ULN, and remained < 2 x ULN~D: Either ALT or AST started > 2 x ULN and remained above 2 x ULN throughout the study"|24 Weeks|evaluable subjects stayed in treatment for 24 weeks and gave at least 4 blood samples for liver function tests during the treatment period||participants|||Number
157460|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
157427|NCT00315328|Secondary|Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||ETDRS letter score||Standard Deviation|Mean
157428|NCT00315328|Secondary|Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||participants|||Number
157429|NCT00315328|Secondary|Mean Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||ETDRS letter score||Standard Deviation|Mean
157430|NCT00315328|Secondary|Distribution of Visual Acuity in the Fellow Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||participants|||Number
157431|NCT00315328|Primary|Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||ETDRS letter score||Standard Deviation|Mean
157432|NCT00315328|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks|"Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.~A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks."|Baseline to 17 weeks|||participants|||Number
157433|NCT00315328|Primary|Mean Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|||ETDRS letter score||Standard Deviation|Mean
157434|NCT00315328|Primary|Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks|Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|17 weeks|Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle.||participants|||Number
157435|NCT00315328|Secondary|Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)|Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.||Units on a scale||Standard Deviation|Mean
157436|NCT00315328|Secondary|Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)|Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.||Units on a scale||Standard Deviation|Mean
157437|NCT00315328|Secondary|Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)|Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.|17 weeks|Number of subjects who completed the 17wk amblyopia treatment index questionnaire evaluating the impact of treatment on the child and family.||Units on a scale||Standard Deviation|Mean
157438|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|"Stereoacuity is scored as seconds of arc with values of: <800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; <800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as within one level meaning change was -1, 0, or +1."|17 or 19 weeks|||Participants|||Number
157439|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks|||Participants|||Number
157461|NCT00315120|Secondary|Work Disability (UST and Sham UST - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
157440|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks|||Participants|||Number
157441|NCT00315328|Secondary|Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|17 or 19 weeks|||Participants|||Number
157442|NCT00315302|Secondary|Visual Acuity Distribution in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|||Participants|||Number
157443|NCT00315302|Secondary|Distribution of Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||Participants|||Number
157444|NCT00315302|Secondary|Mean Change in Visual Acuity in the Sound Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||logMAR units||Standard Deviation|Mean
157445|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia||Participants|||Number
157446|NCT00315302|Secondary|Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia|The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.|18 weeks|Not reported among subjects with severe amblyopia||Participants|||Number
157447|NCT00315302|Primary|Distribution of Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||Participants|||Number
157448|NCT00315302|Primary|Mean Change in Visual Acuity in the Amblyopic Eye|"Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.~A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline."|baseline to 18 weeks|||logMAR units||Standard Deviation|Mean
157449|NCT00315302|Primary|Visual Acuity Distribution in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|||Participants|||Number
157450|NCT00315302|Primary|Visual Acuity Mean Score in the Amblyopic Eye|"Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.~20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst"|18 weeks|Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.||logMAR units||Standard Deviation|Mean
157462|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 12)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|12 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
157463|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 8)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|8 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
157464|NCT00315120|Secondary|Work Disability (OMT and Sham OMT - Week 4)|Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.|4 weeks|Lost 1 or more days of work in past 4 weeks because of low back pain.||Participants who reported lost work days||95% Confidence Interval|Number
157465|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 Weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
157466|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 Weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
157467|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 Weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
157468|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|12 weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
157469|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|8 weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
157470|NCT00315120|Secondary|Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)|The general health scale ranges from 0 to 100, with higher scores representing better general health.|4 weeks|||SF-36 General Health Score||Inter-Quartile Range|Median
157471|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data||RMDQ Scale||Inter-Quartile Range|Median
157472|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data||RMDQ Scale||Inter-Quartile Range|Median
157473|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks|||participants|||Number
157474|NCT00315120|Secondary|Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data||RMDQ Scale||Inter-Quartile Range|Median
157475|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|12 weeks|Week 12 Data||RMDQ Scale||Inter-Quartile Range|Median
157476|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|8 weeks|Week 8 Data||RMDQ Scale||Inter-Quartile Range|Median
157477|NCT00315120|Secondary|Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)|Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.|4 weeks|Week 4 Data||RMDQ Scale||Inter-Quartile Range|Median
157478|NCT00315120|Primary|Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)|"Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a better outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a worse outcome). However, only those better outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%)."|12 weeks|||participants|||Number
157479|NCT00315055|Secondary|Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability|Day 0 to Day 7 post any dose|Solicited reactions were assessed in all participants who received at least 1 injection of study vaccine (Safety Analysis Set) according to the vaccine actually received.||Participants|||Number
157664|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157480|NCT00315055|Secondary|Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.|Day 90 (30 Days post-dose 3)|Geometric Mean Titers were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Titers||95% Confidence Interval|Geometric Mean
157481|NCT00315055|Secondary|Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).|Day 0 (pre-vaccination) and Day 30 post-dose 3|Anti-pertussis antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
157482|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.|Day 90 post first dose|Anti poliovirus antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
157483|NCT00315055|Secondary|Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.|Day 90 post first dose|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
157484|NCT00315055|Primary|Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines|Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 90 post first dose|Seroprotection against HBs was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.||Percentage of Participants|||Number
157485|NCT00314951|Other Pre-specified|Global Cure|Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.|End of Study (Day 40)|The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.||Percentage of Participants|||Number
157486|NCT00314951|Secondary|Recurrence|Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.|Study days 11-40|The mITT population for subjects who met the primary endpoint of cure subjects, were analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.||Percentage of Participants|||Number
157487|NCT00314951|Primary|Cure Rate at End of Therapy|Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.|Study day 10 (+/- 2 days)|Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by >3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.||Percentage of Participants||95% Confidence Interval|Number
157488|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- MMSE|The mean change between baseline and post-treatment in quality of life as measured by the Mini Mental Status Exam (MMSE). Change is computed as the MMSE level at month 2 minus MMSE level at baseline. MMSE is an 11-item questionnaire used to measure global cognitive status with scores ranging from 0 to 30; higher scores are an indication of greater cognitive function.|baseline and 2 months|17 patients provided both a pre- and post-treatment assessment of MMSE.||units on a scale||Standard Deviation|Mean
157489|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FLIE|The mean change from baseline in quality of life as measured by the Functional Living Index Emesis (FLIE) scale during the first 24 and 72 hours of cycle 1. Change at 24 hours was computed as the 24 hour FLIE assessment minus the baseline assessment; whereas, change at 72 hours was computed as the 72 hour FLIE assessment minus the baseline assessment. The FLIE consists of 18 items for nausea and appetite on a 7-point scale. The effect of nausea and vomiting is measured by physical activity, social, and emotional function. Higher scores indicate less difficulty and interference with nausea and vomiting. Scores for the two subscales (nausea and vomiting) range between 0 and 54.|baseline, 24 hours, and 72 hours|For cycle 1, 28 patients with a baseline and follow-up assessment are included in the analysis of change at 24 and 72 hours.||units on a scale||Standard Deviation|Mean
157490|NCT00314808|Secondary|Mean Change From Baseline in Quality of Life -- FACT-Br|The mean change between baseline and post-treatment in quality of life as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br), where change is computed as quality of life at 2 months minus quality of life at baseline. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76.|baseline and 2 months|19 patients provided both baseline and follow-up assessments; however, only 11 patients provided adequate information to compute the score for the additional brain cancer specific concerns subscale.||units on a scale||Standard Deviation|Mean
157491|NCT00314808|Primary|Unacceptable Toxicity Rate|Percentage of participants who experience one or more adverse events attributable to Dronabinol of the following types or grades: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities|2 months|All treated patients||percentage of participants||95% Confidence Interval|Number
157492|NCT00314808|Primary|Tolerability Rate|Percentage of participants where the 2 cycles of Dronabinol is tolerable. The treatment regimen is considered intolerable if (1) at least two adverse events of the following types that are attributed to Dronabinol during the 2 cycles of treatment occur: ≥Grade 3 non-hematologic, ≥Grade 2 hepatic/metabolic or ≥Grade 4 neuro toxicities, or (2) Dronabinol treatment is terminated early due to adverse events|Two months|25 of the 33 patients treated with Dronabinol completed 2 cycles of protocol treatment or terminated protocol treatment due to adverse events. The remaining 8 patients are excluded from this tabulation as they terminated Dronabinol treatment before completion of 2 cycles of treatment for reasons unrelated to adverse events.||percentage of participants||95% Confidence Interval|Number
157493|NCT00314574|Secondary|Number of Participants Assessed for Frequency and Severity of Treatment-emergent Adverse Events|This outcome is represented in the adverse event section of the database.|Week 48|Safety Population: The safety-evaluable population comprised 848 patients (428 Xolair group and 420 placebo group). Patients in the safety-evaluable population were analyzed according to the actual treatment received. One subject was assigned to receive placebo but inadvertently received at least one dose of xolair during the study.||participants|||Number
157494|NCT00314574|Secondary|Change From Baseline in Overall Asthma-related Quality of Life|Change from baseline to week 48 in overall asthma-specific health-related quality of life, as measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score. The AQLQ(S) consists of 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; the overall score is the mean of these 32 items on a scale of 1 to 7 (1 = severe impairment, 7 = no impairment). Overall outcome achieved by mean visit minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.||score on a scale||Standard Deviation|Mean
157495|NCT00314574|Secondary|Change From Baseline in the Number of Puffs Per Day of Beta Agonist Rescue Medication|Change from baseline to week 48 in mean puffs per day of albuterol. Puffs per day was achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo). Five patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.||puffs per day||Standard Deviation|Mean
157496|NCT00314574|Secondary|Change From Baseline in Total Asthma Symptom Scores|Change from baseline to week 48 in Total Asthma Symptom Score (TASS), which included a nocturnal asthma score (0 to 4 scale), morning asthma symptoms (yes or no), and a daytime asthma symptom score (0 to 4 scale, total score range 0 to 9, higher TASS scores represent worse symptoms; breathlessness, tightness in chest, wheezing and cough. Score achieved by week 48 minus baseline.|Baseline and Week 48|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug. Ten patients were missing baseline values and were excluded from the analyses. The Last Observation Carried Forward was used to impute missing values at week 48 for patients who discontinued the study early.||score on a scale||Standard Deviation|Mean
157497|NCT00314574|Primary|Rate of Asthma Exacerbations Over the 48 Week Treatment Period|A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 48 week treatment period in each treatment group.|48 weeks|Modified Intent-to-Treat population included all randomized patients who received at least 1 dose of study drug (Xolair or placebo).||exacerbation/patient-week|||Number
157498|NCT00314106|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|33 months|||Participants|||Number
157499|NCT00314106|Primary|Complete Response|"Determine if the combination of high dose aldesleukin, reinfused cells after lymphocyte depleting chemotherapy and 1200 cGy total body irradiation (TBI) is able to be associated with a modest fraction of patients with metastatic melanoma who can experience a complete response to therapy.~Complete response (CR) is a disappearance of all target lesions."|33 months|||Participants|||Number
157510|NCT00314366|Secondary|New York Heart Association (NYHA) Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.~Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|Baseline and 6 months|||NYHA Functional class||Standard Deviation|Mean
157500|NCT00314366|Secondary|Total Severity Score (Reversible)|"For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress.~Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined."|baseline and 6 months|||units on a scale||Standard Deviation|Mean
157501|NCT00314366|Secondary|Total Severity Score (Rest)|"For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest.~Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.~Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months|||units on a scale||Standard Deviation|Mean
157502|NCT00314366|Secondary|Total Severity Score (Stress)|"For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3–17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling.~Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.~Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."|baseline and 6 months|||units on a scale||Standard Deviation|Mean
157503|NCT00314366|Secondary|Echocardiography (EF) Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline and 6 months|||percentage of blood||Standard Deviation|Mean
157504|NCT00314366|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline and 6 months|data from 9 stem cell patients at 6 months, 10 at baseline||ml/kg/min||Standard Deviation|Mean
157505|NCT00314366|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 6 months|||units on a scale||Standard Deviation|Mean
157506|NCT00314366|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline and 6 months|||ml||Standard Deviation|Mean
157507|NCT00314366|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline and 6 months|||ml||Standard Deviation|Mean
157508|NCT00314366|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|Baseline and 6 months|||percentage of blood||Standard Deviation|Mean
157509|NCT00314366|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).~Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|Baseline and 6 months|||units on a scale||Standard Deviation|Mean
157620|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses'|Number of participants receiving steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Participants|||Number
157511|NCT00314366|Primary|Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events|Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|Baseline and 6 months|The data was analyzed for all participants in control and treated groups.||participants|||Number
157512|NCT00314353|Secondary|Duration of Response||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.||||||
157513|NCT00314353|Secondary|Overall Survival||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.||||||
157514|NCT00314353|Secondary|Toxicity - Adverse Events||Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab||||||
157515|NCT00314353|Secondary|Objective Response Rate||Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.||||||
157516|NCT00314353|Primary|One-year Progression-free Survival (PFS)|Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.|Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.|Primary outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.|||||Number
157517|NCT00314340|Primary|3 Scores on the Addiction Research Center Inventory (ARCI)|The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine–Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital–Chorpromazine–Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.|0, 60, 120, 180, 240, or 300 minutes|Treatment effects at baseline, 60, 120, 180, 240, and 300 min were assessed with repeated measures ANOVA. A liner mixed-effects model with inclusion of interaction terms (1) treatment and time and (2) random order visit number and time was performed.||scores on a scale||Standard Deviation|Mean
157518|NCT00314327|Secondary|Negative Symptoms||13 weeks||||||
157519|NCT00314327|Primary|Patient Acceptance of Injections||13 weeks||||||
157520|NCT00314327|Primary|Side Effects Based Upon Rating Instruments and Lab Tests||13 weeks||||||
157521|NCT00314327|Primary|Treatment Response Based Upon BPRS and CGI Ratings||13 weeks||||||
157522|NCT00314262|Primary|Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.|||participants|||Number
157523|NCT00314262|Primary|Clinical Outcome: Documented Progression|Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.|12 months from time of enrollment|||participants|||Number
157524|NCT00314262|Primary|Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4|Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design.|12 months from time of enrollment|||participants|||Number
157525|NCT00314249|Secondary|Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12|"Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains & 2 component summaries (mental and physical); assessing quality of life, health & functional status.~SF-36 PCS: weighted summary of physical function using all 8 domains.~Scores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.~SF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase, values were imputed using the Last Observation Carried Forward (LOCF) approach.||units on scale||Standard Error|Mean
157581|NCT00313703|Other Pre-specified|Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal|Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder.|3 months|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.||participants|||Number
157526|NCT00314249|Primary|Composite Pain Responder Status|"Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of very much improved or much improved."|At the end of three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).||Pain Responder Participants|||Number
157527|NCT00314249|Primary|Composite Syndrome Responder Status|"Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary [PED], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of very much improved and much improved; and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)"|At the end of the three-month stable dose treatment phase|The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of the three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).||Syndrome Responder Participants|||Number
157528|NCT00314249|Secondary|Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.|"Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.~MFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1=yes, that is true and 5=no, that is not true."|Baseline through end of week 12 (Visit TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments at the end of week 12 (Visit TX12), values were imputed using Last Observation Carried Forward (LOCF).||units on scale||Standard Error|Mean
157529|NCT00314249|Secondary|Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.|"Time-weighted average (area under the curve [AUC]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.~PGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse."|Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).||units on scale||Standard Error|Mean
157530|NCT00314249|Secondary|Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase|"Time-weighted average (area under the curve [AUC]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.~PED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain)."|Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)|The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments for weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).||units on scale||Standard Error|Mean
157531|NCT00314236|Secondary|Frequency of Adverse Events Between Study Groups||12 months|AEs will be coded and tabulated separately by system organ class (SOC) and individual preferred terms (PTs). The number and percentage of subjects who experienced AEs will be summarized in decreasing frequency by using the medical dictionary for regulatory activities (MedDRA) dictionary.||Percentage of participants|||Number
157532|NCT00314236|Secondary|Change From Baseline for Knee-related Pain, Stiffness and Function at 12 Months (WOMAC Parts A, B, C)|The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function.|12 months|Secondary efficacy was evaluated based on pain, stiffness, and function, as well as the macroscopic nature of the cartilage repair. Measurements of pain, stiffness, and function were made at 3, 6, and 12 months post-treatment using the WOMAC questionnaire and SF-36v2. WORMS scoring was conducted on 12-month post-treatment MRI scans.||Units on a scale||Standard Error|Least Squares Mean
157533|NCT00314236|Primary|Repair Cartilage T2 Relaxation Time|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the repair tissue quality of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI T2 mapping. T2 maps are created by calculating the T2 relaxation times for repair tissue and cartilage plates for every voxel (picture element of a MRI scan containing the average signal information of a specific spatial location of the imaged body).|12 months|Sample size for repair tissue quality was calculated, using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 10. Under these assumptions, the sample size per group was calculated to be 11 subjects (or 22 subjects in total)||milliseconds||Standard Error|Least Squares Mean
157582|NCT00313703|Primary|Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge|Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain|24 hours after Emergency Department (ED) discharge|A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.||Participants|||Number
157534|NCT00314236|Primary|Degree of Filling of the Lesion by Repair Tissue at 12 Months Through MRI.|Evaluate the efficacy of BST-CarGel® applied to a microfractured lesion as compared to microfracture alone on the degree of lesion filling of the study knee in subjects with symptomatic pain associated with cartilage damage using MRI scans. The MR images will be acquired using high resolution 3D cartilage imaging sequences, so-called cartilage morphology sequences.|12 months|Sample size for degree of lesion filling was calculated using a standard t test, with an anticipated relevant difference of 15% between treatments and a common SD of 15. Under these assumptions, the sample size per group was calculated to be 23 subjects (or 46 subjects in total)||Percentage of lesion fill||Standard Error|Least Squares Mean
157535|NCT00314145|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Events and Treatment Emergent Systemic Reactions Post-Vaccination With Either ChimeriVax™-JE or JE-Vax®|"Treatment emergent local adverse events: Pain, Erythema, Pruritus, Swelling, Induration, and others as reported.~Treatment emergent systemic reactions: Fatigue, Malaise, Chills, Pyrexia, Headache, Myalgia, Arthralgia, Diarrhea, Nausea, Vomiting, and Rash."|Day 0 (Pre-vaccination) up to 60 days post-first vaccination|Treatment emergent local adverse events and systemic reactions were assessed in all subjects who had at least one injection (ChimeriVax™-JE, JE-Vax®, or placebo), according to the treatment actually received (Safety Population).||Participants|||Number
157536|NCT00314145|Secondary|Number of Participants in the Japanese Encephalitis (Homologous Virus) Neutralizing Antibody Titer Categories on Day 60 Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Day 60 post-first vaccination|Antibody titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).||Participants|||Number
157537|NCT00314145|Secondary|Neutralizing Antibody Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50).|Up to Day 60 post-first vaccination|Geometric mean titers were assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).||Titers||95% Confidence Interval|Geometric Mean
157538|NCT00314145|Primary|Number of Participants With Japanese Encephalitis (Homologous Virus) Seroconversion Following Either ChimeriVax™-JE or JE-Vax® Vaccination|Antibodies to Japanese encephalitis (JE) were measured by 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a titer of ≥ 1:10.|Up to Day 60 post-first vaccination|Seroconversion was assessed in all participants who were seronegative to JE (both Nakayama and ChimeriVax™-JE strains) at baseline and had no protocol violations that would have interfered with evaluation of primary outcomes (Efficacy Population).||Participants|||Number
157539|NCT00314132|Primary|Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo|"Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.~Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported."|Day 0 up to 30 days post-vaccination|Treatment emergent local adverse reactions and systemic reactions were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).||Participants|||Number
157540|NCT00314132|Primary|Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo|"Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered actively solicited through Day 30."|Day 0 up to 30 days post-vaccination|Treatment related adverse events were assessed in all participants who received an injection of study treatment, according to the treatment they received (Safety Population).||Participants|||Number
157541|NCT00313911|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable."|Day 0 up to Day 7 Post-injection|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group.||Participants|||Number
157542|NCT00313911|Secondary|Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|"Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.~Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively."|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.||Percentage of Participants|||Number
157543|NCT00313911|Secondary|Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo|Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.|Day 30 post-dose 3|Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.||Titers||95% Confidence Interval|Geometric Mean
157544|NCT00313911|Primary|Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.|High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.|Day 0 up to Day 7 post-injection|The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group.||Participants|||Number
157545|NCT00313846|Secondary|"Daily Maximum Pain Right Now Score for the Primary Osteoarthritis (OA) Pain Site"|The daily maximum ‘pain right now’ score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. “Pain right now” scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).|7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.|Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.||units on a scale||Standard Error|Mean
157546|NCT00313846|Primary|The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.|"Inadequate analgesia:~“average pain over the last 24 hours” score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;~>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;~ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia."|"Double-blind phase ( 28 days): reaching inadequate analgesia on any 2 days of the 7-day dosing periods"|The Full Analysis Population (N = 326) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug and had at least 1 primary efficacy observation during the double-blind phase.||days||Standard Error|Mean
157547|NCT00313820|Secondary|QANeP - Pain Rating Scales|Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).|Baseline, Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12 [LOCF].||scores on scale||Standard Deviation|Mean
157548|NCT00313820|Secondary|Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold|"QANeP: assessment of sensory threshold: subject responds yes when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline)."|Baseline, Week 12|ITT; Week 12 [LOCF].||scores on scale||Standard Deviation|Mean
157549|NCT00313820|Secondary|Clinical Global Impression of Change (CGIC)|CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
157550|NCT00313820|Secondary|Patient Global Impression of Change (PGIC)|PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
157551|NCT00313820|Secondary|EQ-5D - VAS|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
157552|NCT00313820|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, “confined to bed”). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Week 12|ITT||scores on scale||Standard Error|Least Squares Mean
157553|NCT00313820|Secondary|Hospital Anxiety and Depression Scale (HADS) - ITT Population|HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Week 12|ITT; Week 12 [LOCF]||scores on scale||Standard Error|Least Squares Mean
157554|NCT00313820|Secondary|Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep|MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 12|ITT||participants|||Number
157555|NCT00313820|Secondary|Medical Outcome Study (MOS) Sleep Scale|MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
157583|NCT00313612|Secondary|Time to Disease Progression by RECIST and/or CA 125|Time to disease progression by RECIST and/or CA 125|Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks|||months||95% Confidence Interval|Median
157556|NCT00313820|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.|Week 12|ITT; (N) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12/Last observation carried forward (LOCF).||scores on scale||Standard Error|Least Squares Mean
157557|NCT00313820|Secondary|Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only|SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.|Week 12|ITT||millimeters||Standard Error|Least Squares Mean
157558|NCT00313820|Secondary|Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])|DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; endpoint = Week 12 or ET.||scores on scale||Standard Error|Least Squares Mean
157559|NCT00313820|Secondary|Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint|50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET||participants|||Number
157560|NCT00313820|Secondary|Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint|30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.|Baseline, Week 12|ITT; endpoint = Week 12 or ET||participants|||Number
157561|NCT00313820|Secondary|Pain Score as Measured by DPRS|Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12|ITT; (n) = number of participants with analyzable data at observation for pregabalin and placebo, respectively; weeks as specified in timeframe through Week 12 [ET]||scores on scale||Standard Error|Least Squares Mean
157562|NCT00313820|Primary|Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)|Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.|Up to Week 12|Intent to Treat (ITT): received at least 1 dose study medication and completed at least 1 post-baseline assessment. Endpoint = Week 12 or ET||scores on scale||Standard Error|Least Squares Mean
157563|NCT00313781|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
157564|NCT00313781|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
157565|NCT00313781|Secondary|Maximum Observed Plasma Concentration (Cmax) for CP-751,871||Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
157566|NCT00313781|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871|Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)|The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.|||||
157567|NCT00313781|Secondary|Pain Measured by the Modified Brief Pain Inventory‑Short Form (mBPI‑sf Modified Pfizer)|"The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block."|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.|||||
157621|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses'|Number of antibiotic courses (i.e. number of antibiotic prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Antibiotic courses||Standard Deviation|Mean
157568|NCT00313781|Secondary|Quality of Life Measured by the Functional Assessment of Cancer Treatment‑Prostate (FACT‑P)|The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.|Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)|The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.|||||
157569|NCT00313781|Secondary|Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs|Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.||Number of IGF-1R positive CTCs/7.5 mL||Standard Deviation|Mean
157570|NCT00313781|Secondary|Total Number of Circulation Tumor Cells (CTCs)|Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.|Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)|Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.||Number of CTCs/7.5 mL||Standard Deviation|Mean
157571|NCT00313781|Secondary|Population PK Parameters of CP-751,871|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations|Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)||||||
157572|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at the Last Follow-up Visit|Levels of HAHA in serum were detected at the last follow-up visit.|The last follow-up visit (150 days post last dose)|All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.||mg/dl||Standard Deviation|Mean
157573|NCT00313781|Secondary|Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)|Levels of HAHA in serum were detected at baseline.|Baseline (Day 1 of Cycle 1)|All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.||mg/deciliter (dl)||Standard Deviation|Mean
157574|NCT00313781|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.|Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)|Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.||Months||95% Confidence Interval|Median
157575|NCT00313781|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Best Response|Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as >= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.|Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)|Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.||Percentage of participants||90% Confidence Interval|Mean
157576|NCT00313716|Secondary|Incidence of Infection|occurrence of infection was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis||participants|||Number
157577|NCT00313716|Secondary|Incidence of Adult Respiratory Distress Syndrome (ARDS)|development of ARDS was a primary safety outcome for the transfusion threshold randomization|within 30 days after injury|Intention to treat analysis||participants|||Number
157578|NCT00313716|Secondary|Mortality Rate|mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization|up to 6 months after injury|Intention to treat analysis||participants|||Number
157579|NCT00313716|Secondary|Disability Rating Scale|Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status.|at 6 months|Intention to treat analysis||units on a scale||Inter-Quartile Range|Median
157580|NCT00313716|Primary|Glasgow Outcome Scale|Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead)|at 6 months after injury|Intention to treat. Multiple imputation for missing 6-month GOS data was performed assuming data were missing at random using chained equations (R, R Foundation for Statistical Computing).The imputation was based on a logistic regression model with baseline covariates. Results were aggregated over 20 imputed sets using variance formula by Rubin.||participants|||Number
157584|NCT00313612|Primary|Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)|Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.|Every two cycles for up to 24 weeks.|30 patients were analyzed. Eight patients discontinued treatment before 2 cycles.||participants|||Number
157585|NCT00313586|Primary|Proportion of Patients With Clinical Response|"Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria:~World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett)~Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.)~Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)"|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.|All treated patients are included in the analysis.||Proportion of patients||95% Confidence Interval|Number
157586|NCT00313443|Secondary|Presence of Any Adverse Effect Attributable to Amiodarone.|Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)|Cumulated time on amiodarone (varies in each patient)|||Patients|||Number
157587|NCT00313443|Secondary|Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations|Number of patients having complications (if any) caused by fat tissue needle aspirations|24 hours after needle aspiration|||Patients|||Number
157588|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.|Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.|Cumulated time on amiodarone (varies in each patient)|||Logistic regression OR|||Number
157589|NCT00313443|Primary|Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.|Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.|One single measure, taken just before daily administration|||Correlation coefficient R|||Number
157590|NCT00313443|Primary|Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.|Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.|One single measure|||Correlation coefficient R|||Number
157591|NCT00313313|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
157592|NCT00313313|Secondary|Percentage of Participants Achieving A1C < 7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
157593|NCT00313313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
157594|NCT00313313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.||percent||Standard Error|Mean
157595|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.||percentage of participants||95% Confidence Interval|Number
157596|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization up to high dose termination, 1-Oct-2007|Participants who were concomitantly randomized in Phase B were summarized.||participants|||Number
157597|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Phase B Adjusted Treatment Period - Treated Participants Randomized in Phase B|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events included major bleeding, clinically relevant non-major bleeding and minor bleeding. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants concomitantly randomized in Phase B who received at least one dose of placebo or apixaban were summarized.||percentage of participants||95% Confidence Interval|Number
157598|NCT00313300|Secondary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Phase B Adjusted Treatment Period- Treated Participants Randomized in Phase B|Bleeding was assessed using ISTH guidelines. Events were adjudicated by the CEC. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups and the lower duration of exposure. Phase B Adjusted Treatment Period=safety events occurring in the period from first dose through 2 days (or through 30 days for SAE tabulations) after the earliest of last dose date or 1-Oct-2007 (termination date for the 10 mg BID group).|From first dose (Day 1) to last dose, plus 2 days (plus 30 days for SAEs), up to high dose termination, 1 October 2007|Participants randomized in Phase B only who received at least one dose of placebo or apixaban were summarized.||percentage of participants||95% Confidence Interval|Number
157599|NCT00313300|Secondary|Number of Participants With Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, Non-Hemorrhagic Stroke During the Phase B Adjusted Intended Treatment Period - Participants Randomized in Phase B|Phase B Adjusted Intended Treatment Period=day of randomization and ends on termination date of high dose apixaban, 1-Oct-2007. The analyses of Phase B data across all doses of apixaban are secondary due to the premature termination of the apixaban high dose groups and the lower duration of exposure.|Day of randomization and ends on high dose termination date, 1-Oct-2007|Participants who were concomitantly randomized in Phase B only were summarized (start of Phase B, March 2007, to termination of high doses in Phase B, October 2007) .||participants|||Number
157600|NCT00313300|Secondary|Event Rate of Confirmed Adjudicated Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the ISTH guidelines. Events were adjudicated by the Clinical Events Committee. Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%).|from first dose (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban were analyzed.||percentage of participants||95% Confidence Interval|Number
157601|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated All-Cause Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia, and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B|Day of randomization to 182 days after day of randomization (183 days)|Randomized participants were summarized.||participants|||Number
157602|NCT00313300|Secondary|Event Rate for Adjudicated All Bleeding Events During the Treatment Period - Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated (%). All bleeding events includes major bleeding, clinically relevant non-major bleeding and minor bleeding. Treatment Period refers to the period from first dose through 2 days, or through 30 days for Serious Adverse Event (SAE) tabulations, after discontinuation of study drug. Data in this outcome are combined across Phase A and Phase B.|first dose (Day 1) to last dose plus 2 days (or for SAEs, plus 30 days), up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban are summarized. The analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.||percentage of participants||95% Confidence Interval|Number
157603|NCT00313300|Secondary|Number of Participants With a Composite of Adjudicated Cardiovascular Death, Non-Fatal Myocardial Infarction, Severe Recurrent Ischemia and Non-Hemorrhagic Stroke During the Intended Treatment Period - Randomized Participants|Events were adjudicated by the Clinical Events Committee (CEC). Intended Treatment Period refers to the period starting on the day of randomization and ending 182 days after the day of randomization (for a total period duration of 183 days). Data in this outcome are combined across Phase A and Phase B.|Randomization to 182 days after randomization (183 days)|Participants who randomized to placebo or low dose apixaban are summarized. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.||participants|||Number
157604|NCT00313300|Primary|Event Rate of Composite of Adjudicated Major Bleeding and Clinically Relevant Non-Major Bleeding During the Treatment Period- Treated Participants With Placebo or Apixaban Low Doses|Bleeding was assessed using the International Society on Thrombosis and Hemostasis (ISTH) guidelines. Events were adjudicated by the Clinical Events Committee (CEC). Event rate was number of participants with events divided by the number of participants treated, measured as a percentage (%). The primary outcome is based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B. The analyses of Phase B data across all doses of apixaban are secondary because of the premature termination of the apixaban high-dose groups (10mg BID, 20mg QD) and the resulting lower duration of exposure for these groups.|From first dose of study drug (Day 1) to last dose plus 2 days, up to Year 2 of the Study|Participants who received at least one dose of placebo or low dose apixaban. Due to the premature termination of the 2 apixaban high-dose groups (10 mg BID and 20 mg QD) in Phase B, the primary analyses reported are based on data for the placebo and 2 apixaban low-dose groups (2.5 mg BID and 10 mg QD) combined across Phase A and Phase B.||percentage of participants||95% Confidence Interval|Number
157605|NCT00313209|Secondary|Shortness of Breath Questionnaire (SOBQ) Total Score|"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity."|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
157606|NCT00313209|Secondary|Transition Dyspnea Index (TDI) Focal Score|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
157607|NCT00313209|Secondary|COPD Exacerbation Rate (Mild, Moderate or Severe)|Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [ATS / ERS 2005].|24 weeks treatment period|ITT analysis||exacerbations per patient per year||95% Confidence Interval|Mean
157608|NCT00313209|Secondary|Post-bronchodilator FEV1|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
157609|NCT00313209|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 24 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
157610|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes|Baseline to 12 weeks|||litres per hour||Standard Deviation|Mean
157611|NCT00313170|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|The measure of dispersion for mean population clearance is based on the estimated inter-individual variance.|Baseline to 12 weeks|Participants who had PK samples only||litres per hour||Standard Deviation|Mean
157612|NCT00313170|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD, provided that the SD was present at least 154 days from randomisation (ie. SD>=24 weeks - with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria in Solid Tumours) scan data up to the data cut-off, 13th June 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation.|||Percentage of patients|||Number
157613|NCT00313170|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response (CR) or confirmed Partial Response (PR)|RECIST tumour assessments were carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut-off on 13th June 2008||||||
157614|NCT00313170|Secondary|Time to Progression (TTP)|Median time (in days) from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation until data cut off on 13th June 2008|||Days||Full Range|Median
157615|NCT00313170|Primary|Objective Response (OR)|Number of participants who were objective responders over the number of participants evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diameters of the measurable lesions + no new lesions + no progression of non-measurable lesions)|RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomisation to until data cut off on 13th June 2008|||Percentage of patients|||Number
157616|NCT00313144|Secondary|ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening|"All IgG and IgM titers at screening were ≤ 4. A 2-dilution step increase was defined as follows:~The titer at each 6-month visit must be ≥ 4 when the screening titer = 0~Each 6-month visit titer / screening titer should be ≥ 4. 6 month window periods are: baseline to ≤6 months, >6 months to ≤12 months, >12 months to ≤18 months, and >18 months to ≤24 months"|Baseline to 24 Months|Subjects who participated in the blood draws with data available during each window period||Participants|||Number
157617|NCT00313144|Secondary|Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin) and renal (Blood urea nitrogen (BUN), creatinine) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period||mg/dL||Full Range|Median
157618|NCT00313144|Secondary|Hepatic Chemistry Parameters: Change From Baseline/Screening|Summary of changes in hepatic (total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase) parameters from screening/baseline through each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Subjects who participated in the blood draws with data available during each window period||U/L||Full Range|Median
157619|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses'|Number of steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Steroid Pulse Courses||Standard Deviation|Mean
157929|NCT00309608|Secondary|Percentage of Patients With HbA1c<=7.0% at Week 12|Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.|week 12|This population includes the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used as the imputation rule.||Percentage of Patients|||Number
157622|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics'|Number of participants taking antibiotics one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||Participants|||Number
157623|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital'|Mean LOS during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 months|Participants with data available during each window period||Days||Standard Deviation|Mean
157624|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations'|Number of participants with indicated number of hospitalizations during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period||Participants|||Number
157625|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits'|Mean number of ER visits one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|One year prior to baseline to 24 months post-baseline|Participants with data available during each window period||ER visits per time period||Standard Deviation|Mean
157626|NCT00313144|Secondary|Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits'|Number of participants with indicated number of ER visits (0, 1, 2, 3, ≥4 ER visits per participant) during each window period (Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months)|Baseline to 24 Months|Participants with data available during each window period||Participants|||Number
157627|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months|SF-36 Scores- baseline thru 24 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 24 months|Participants with baseline and participating during the period from baseline to ≤24 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157628|NCT00313144|Primary|HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤18 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157629|NCT00313144|Primary|HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months|SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Baseline to 12 months|Participants with baseline and participating during the period from baseline to ≤12 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157630|NCT00313144|Primary|HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157631|NCT00313144|Primary|HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months|SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157632|NCT00313144|Primary|HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157643|NCT00313014|Primary|Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.|"Subjects were evaluated during the double-blind phase for average pain over the last 24 hours prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)"|Last 24 hours score at weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Error|Mean
157633|NCT00313144|Primary|HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157634|NCT00313144|Primary|HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157635|NCT00313144|Primary|HRQoL 'Vitality (VT)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157636|NCT00313144|Primary|HRQoL 'General Health (GH)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157637|NCT00313144|Primary|HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157638|NCT00313144|Primary|HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157639|NCT00313144|Primary|HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months|Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.|Screening to ≤ 6 Months|Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL||Scores on a scale||Standard Deviation|Mean
157640|NCT00313014|Secondary|The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.|"The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).~Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance."|Weeks 4, 8, 12 of the double-blind phase|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Error|Mean
157641|NCT00313014|Secondary|Oswestry Disability Index (ODI) Score (V 2.0)|"The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.~The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)"|Weeks 4, 8, 12|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||units on a scale||Standard Error|Mean
157642|NCT00313014|Secondary|Mean Daily Number of Supplemental Analgesic Tablets|The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase|Double-blind phase (84 days)|Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||tablets||Standard Error|Mean
157644|NCT00312923|Secondary|Triglycerides||12 weeks|||mg/dl||Standard Deviation|Mean
157645|NCT00312923|Primary|LDL Cholesterol|Low density lipoprotein cholesterol|12 weeks|||mg/dl||Standard Deviation|Mean
157650|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
157651|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
157652|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
157653|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
157654|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
157655|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
157656|NCT00312858|Other Pre-specified|Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response|Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4|6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes contained in Prevnar™.||Participants|||Number
157657|NCT00312858|Other Pre-specified|Antibody Response to Varicella - Geometric Mean Titer|Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures||gpELISA units/mL||95% Confidence Interval|Geometric Mean
157658|NCT00312858|Other Pre-specified|Antibody Response to Hepatitis A – Geometric Mean Titer|Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures||mIU/mL||95% Confidence Interval|Geometric Mean
157659|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157660|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157661|NCT00312858|Primary|Participants With 1 or More Serious Vaccine-related Adverse Experience|Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157662|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157663|NCT00312858|Primary|Participants With Elevated Temperature (≥102.2F/ ≥39.0C)|Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157665|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157666|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157667|NCT00312858|Primary|Participants With 1 or More Injection-site Adverse Experience|Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157668|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience.|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart|6 months|Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157669|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.|4 weeks post dose 2|Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157670|NCT00312858|Primary|Participants With 1 or More Systemic Adverse Experience|Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.|6 weeks post dose 1|Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)||Participants|||Number
157671|NCT00312858|Primary|Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers|Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay|6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)|Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures||mcg/mL||95% Confidence Interval|Geometric Mean
157672|NCT00312858|Primary|Antibody Response to Varicella - Participants With a Serological Response|Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)|6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)|Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.||Participants|||Number
157673|NCT00312858|Primary|Antibody Response to Hepatitis A - Participants With a Serological Response|Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus|4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)|Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.||Participants|||Number
157674|NCT00312845|Secondary|Overall Response Rate|Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|The response-evaluable population was defined as all subjects in the ITT population who received at least 1 dose of VELCADE or rituximab, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline, and had at least 1 post-baseline disease assessment by independent radiology reviewers/IRC.||participants|||Number
157675|NCT00312845|Primary|Progression Free Survival|Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.|Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.|Intention to treat (ITT) population is defined as all patients randomized to the trial.||days||95% Confidence Interval|Median
157676|NCT00312728|Secondary|Number of Participants With Selected Adverse Events|"Number of participants with selected adverse events (all grades based on NCI CTCAE) included any grade CNS hemorrhage, any grade pulmonary hemorrhage, any grade gastrointestinal (GI) perforation, Grade ≥ 2 arterial thromboembolic event, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 non-CNS non-pulmonary hemorrhage, Grade ≥ 3 proteinuria, Grade ≥ 3 proteinuria, Grade ≥ 3 hypertension, any serious adverse event*, and any adverse event leading to study treatment discontinuation.~*For serious adverse events, please see Adverse Event Reporting Section."|From start of bevacizumab treatment to 60 days following discontinuation of bevacizumab (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.||participants|||Number
157677|NCT00312728|Secondary|Number of Participants With OS in First-line and Second-line Settings [1−Year or More Survival]|To assess the number of participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.||participants|||Number
157968|NCT00308737|Secondary|Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement|TLC Decrease of ≥ 15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data||Participants|||Number
157678|NCT00312728|Secondary|OS in First-line and Second-line Settings|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The efficacy-evaluable population consisted of all patients who received at least one dose of bevacizumab.||Months||95% Confidence Interval|Median
157679|NCT00312728|Secondary|Number of Participants With Overall Survival (OS) in First-line Setting [1−Year or More Survival]|Number of Participants with overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.||participants|||Number
157680|NCT00312728|Secondary|Overall Survival (OS) in First-line Setting|To assess overall survival in the subset of subjects treated in the first-line setting with bevacizumab plus either chemotherapy or erlotinib for non-squamous NSCLC with previously treated brain metastases.|Time from enrollment to death from any cause (up to 2 years)|The first-line efficacy-evaluable population consisted of 70 patients who received at least one dose of bevacizumab.||Months||95% Confidence Interval|Median
157681|NCT00312728|Primary|Percentage of Participants With Symptomatic National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0 (NCI CTCAE) Grade ≥2 Central Nervous System (CNS) Hemorrhage|"The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage.~Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death"|From the first administration of bevacizumab until 60 days after discontinuation of bevacizumab treatment was reported (up to 2 years)|The safety-evaluable population consisted of all patients who received at least one dose of bevacizumab.||percentage of participants||90% Confidence Interval|Number
157682|NCT00312572|Primary|The Percentage of Subjects Who Completed the 14-day Double-blind Phase.|The indicator variable was 1 = completion, and 0 = noncompletion. For the primary efficacy analysis, the percentage of subjects who completed the double-blind phase was computed with its 95% confidence interval (CI) for each treatment regimen (starting dose of BTDS 10 or BTDS 20) across and within baseline Vicodin® stratum (15 to 22.5mg/day vs >22.5 to 30 mg/day as determined by the daily average hydrocodone dose during the run-in period).|14 days|Full Analysis Population: (N = 198) consisted of all subjects who were randomized into the double-blind phase, received at least 1 dose of BTDS during the double-blind phase, and had at least 1 efficacy observation during the double-blind phase, and had no evidence of impaired liver function at screening and prerandomization.||Percentage of Participants||95% Confidence Interval|Number
157683|NCT00312494|Secondary|Anonymized Pharmacogenomic Blood Draw|Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.|Baseline|All subjects eligible (optional consent); samples were not to be analyzed as part of the current protocol and the analysis was not to be covered by the statistical analysis plan.||mg|||Number
157684|NCT00312494|Secondary|Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score|LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.||scores on scale||Standard Error|Least Squares Mean
157685|NCT00312494|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score|GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations.||scores on scale||Standard Error|Least Squares Mean
157686|NCT00312494|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score|PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).|Baseline, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
157687|NCT00312494|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Scores|CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.|Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
157688|NCT00312494|Secondary|Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score|CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
157689|NCT00312494|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).|Baseline, Week 1, Week 2, Week 3|ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
157690|NCT00312494|Secondary|Change From Baseline to Week 1 and Week 2 in YMRS|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 1, Week 2|ITT population excluding data from 2 sites that were closed to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.||scores on scale||Standard Error|Least Squares Mean
157691|NCT00312494|Primary|Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)|YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech [rate and amount], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).|Baseline, Week 3|Intent to Treat population (ITT): all randomized subjects who received at least 1 dose of double-blind medication, who had 1 baseline and at least 1 post-baseline primary efficacy evaluation; excluding data from 2 sites that were closed due to Good Clinical Practices (GCP) deviations.||scores on scale||Standard Error|Least Squares Mean
157692|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)|"The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.~Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.~A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation|||Weeks||Inter-Quartile Range|Median
157693|NCT00312377|Secondary|Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).|"The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.~Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.~A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days."|FACT-L questionnaires are to be administered every 3 weeks after randomisation|||Weeks||Inter-Quartile Range|Median
157694|NCT00312377|Secondary|Duration of Response (DoR)|Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression|||Weeks||Full Range|Median
157695|NCT00312377|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.|RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression|||Participants|||Number
157696|NCT00312377|Secondary|Objective Response Rate (ORR)|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.|Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression|||Participants|||Number
157697|NCT00312377|Secondary|Overall Survival (OS) in the Female Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||95% Confidence Interval|Median
157698|NCT00312377|Secondary|Overall Survival (OS) in the Overall Population|Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).|Time to death in months|||Months||95% Confidence Interval|Median
157699|NCT00312377|Primary|Progression-Free Survival (PFS) in the Female Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months|||Weeks||95% Confidence Interval|Median
157700|NCT00312377|Primary|Progression-Free Survival (PFS) in the Overall Population|Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.|RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months|||Weeks||95% Confidence Interval|Median
157701|NCT00312338|Primary|Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42|||Percent of resistant isolates|||Number
157702|NCT00312338|Primary|Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0, Day 42|||Percent of resistant isolates|||Number
157703|NCT00312338|Primary|Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation|"Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI).~0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic"|Day 0 and Day 42|||Percent of resistant isolates|||Number
157704|NCT00312221|Secondary|The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase|The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12 of the Double-blind Phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Units on a scale||Standard Error|Mean
157705|NCT00312221|Secondary|The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase|"The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.~The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst)."|Weeks 4, 8 and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Units on a scale||Standard Error|Mean
157706|NCT00312221|Secondary|The Mean Daily Number of Supplemental Analgesic Medication Tablets|The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.|Double-blind phase (84 days)|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Tablets||Standard Error|Mean
157707|NCT00312221|Primary|“Average Pain Over the Last 24 Hours” Scores at Weeks 4, 8, and 12 of the Double-blind Phase.|The “average pain over the last 24 hours” score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).|Weeks 4, 8, and 12 of the double-blind phase|Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.||Units on a scale||Standard Error|Mean
157708|NCT00312208|Secondary|Death From Any Cause (Overall Survival)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up of 65 months|The analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median survival time, median time-to-event was not reached in any group; therefore, number of participants who died was presented.||Participants|||Number
157709|NCT00312208|Primary|Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)|The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|Median follow-up 65 months|The primary efficacy analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median disease free survival time, median time-to-event was not reached in any group; therefore, number of participants with relapse was presented.||Participants|||Number
157969|NCT00308737|Secondary|Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement|FVC Decrease of ≥15% from Baseline Value at Last Measurement|Baseline to Month 24|participants in ITT population with available data||participants|||Number
157710|NCT00312195|Secondary|The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).|The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.||Tablets||Standard Error|Least Squares Mean
157711|NCT00312195|Secondary|The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase|"Note: The total numbers of Subjects w/ineffective treatment or who discont'd for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.||participants|||Number
157712|NCT00312195|Secondary|Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment|"The time of ineffective treatment was calculated as the earliest of the following:~The date the subject first took >1 gram of acetaminophen,~The visit date when ineffective treatment was first determined, or~The date the last patch was removed."|14 days|Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.||Days||Standard Error|Mean
157713|NCT00312195|Primary|The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.|"Ineffective treatment was defined as:~Subject took >1 gram of acetaminophen in a 24-hour period, or~Subject required a change in transdermal patch (TDS) dose, or~Subject had difficulty in keeping the TDS on, or~Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).~Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment."|Double-blind phase (14 days)|The Full Analysis Population (N = 266) for efficacy analyses included all subjects who were randomized and provided at least 1 efficacy assessment in the double-blind phase.||participants|||Number
157714|NCT00311766|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||70 days|The population for safety analysis included all patients who were randomized and received at least one dose of study medication and had at one safety parameter recorded.||Participants|||Number
157715|NCT00311766|Secondary|Number of Participants Whose Wounds Have Healed|Wound healing means that the wound has closed without any drainage|56 days|The population for efficacy analysis will be the Full Analysis (FA) population. The FA analysis included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded.||participants|||Number
157716|NCT00311584|Primary|Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)|The patient’s best overall response obtained during Reporting Periods 1 and 2 will be scored as “best response”. Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response).|up to 6 courses of therapy, or about 6 months|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.||participants|||Number
157717|NCT00311402|Post-Hoc|Number of Patients With Composite Endpoint of Stroke or Major Bleeding|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage, subarachnoid haemorrhage and major bleeding. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157718|NCT00311402|Post-Hoc|Number of Patients With Intracranial Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157719|NCT00311402|Post-Hoc|Number of Patients With Stroke|This is a composite endpoint of cerebral infarction, brain (cerebral) hemorrhage and subarachnoid haemorrhage. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157859|NCT00310466|Primary|Daily Rhinoconjunctivitis Symptom Score|A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.|Birch pollen season 2006|||Units on a scale (0-18)||Standard Deviation|Mean
157720|NCT00311402|Secondary|Number of Patients With Ischemic Vascular Event Composite Endpoint|This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157721|NCT00311402|Secondary|Number of Patients With Other Vascular Events|This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157722|NCT00311402|Secondary|Number of Patients With Acute Coronary Syndrome (ACS)|ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157723|NCT00311402|Secondary|Number of Patients With Transient Ischemic Attack (TIA)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157724|NCT00311402|Secondary|Number of Patients With Subarachnoid Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157725|NCT00311402|Secondary|Number of Patients With Brain (Cerebral) Haemorrhage|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157726|NCT00311402|Primary|Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal)|All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner.|Up to 124 weeks|All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration.||patients|||Number
157727|NCT00311376|Secondary|Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire|Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients’ lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Number on a Scale (Score)||Standard Deviation|Mean
157728|NCT00311376|Secondary|Change From Baseline in Maximum Detrusor Pressure (MDP)|Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Centimeters of water (cm H20)||Standard Deviation|Mean
157729|NCT00311376|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Millimeters (mL) of urine||Standard Deviation|Mean
157730|NCT00311376|Primary|Change From Baseline in Number of Weekly Episodes of Urinary Incontinence|Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 6|Intent-to-Treat defined as all patients who started the study (randomized)||Number of Weekly Episodes||Standard Deviation|Mean
157731|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
157732|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
157733|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
157734|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
157735|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available.||participants|||Number
157736|NCT00311363|Secondary|Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 13 had missing data||points on a scale||Standard Deviation|Mean
157737|NCT00311363|Secondary|Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description, and 12 had missing data||hours||Standard Deviation|Mean
157738|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.||points on a scale||Standard Deviation|Mean
157771|NCT00311311|Secondary|Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant|Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||milligram per deciliter (mg/dL)||Standard Deviation|Mean
157739|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. . The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.||points on a scale||Standard Deviation|Mean
157740|NCT00311363|Secondary|Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 12 had missing data.||points on a scale||Standard Deviation|Mean
157741|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0-24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description and 3 had missing data.||participants|||Number
157742|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF|The CGI-I scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.||participants|||Number
157743|NCT00311363|Secondary|Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF|The IRLS Rating scale is a measure of disease severity. The scale reflects participant-reported assessment of sensory and motor features and associated sleep problems in RLS. In addition, items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. Total score ranges from 0-40 points, with 40 being the most severe.|Days 1 to 168 (Baseline to Week 24 of SB Phase)|Single-blind Intent-to-Treat (SB ITT) Population: all participants who enrolled into the study, received at least one dose (or any portion of dose) of SB study drug, and for whom at least one SB visit (Weeks 0 through 24) IRLS total score and investigator-rated CGI-I was available. Some participants did not satisfy this description.||points on a scale||Standard Deviation|Mean
157744|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
157745|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
157772|NCT00311311|Secondary|Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant|Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||micromole/liter (µmol/L)||Standard Deviation|Mean
157746|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
157747|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
157748|NCT00311363|Secondary|Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from “excellent” to “poor” and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
157749|NCT00311363|Secondary|Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)|The 24-hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event; thus, no data are presented for the DB GEn 1200 mg arm.|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||hours||95% Confidence Interval|Median
157750|NCT00311363|Secondary|Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)|In the 24-hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hr intervals (8 AM to 12 PM, 12 to 4 PM, 4 to 8 PM, 6 to 10 PM, 8 to Midnight, Midnight to 4 AM, 4 to 8 AM)|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population Participants who were missing severity scores for more than two 30-min windows during a 4-hour period had their maximum severity rating for the 4-hour period set to missing. At Randomization (Week 24), there was one participant in each arm with missing 24-hour RLS Record data.||participants|||Number
157751|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score|The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
157752|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||hours||Standard Deviation|Mean
157773|NCT00311311|Secondary|Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant|IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||pg/mL||Standard Deviation|Mean
157753|NCT00311363|Secondary|Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
157754|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
157755|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF|The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
157756|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response on the participant-rated CGI-I was defined as a rating of very much improved (score of 1) or much improved (score of 2) compared to Baseline of the SB phase."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||percentage of participants|||Number
157757|NCT00311363|Secondary|Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse compared to baseline."|Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
157758|NCT00311363|Secondary|Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF|The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||participants|||Number
157759|NCT00311363|Secondary|Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF|The CGI-C scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline. For this endpoint, “response” on the CGI-C was defined as participants with a rating of “no change,” (score of 4) ”minimally improved,” (score of 3) “much improved,” (score of 2) or “very much improved” (score of 1) compared to Randomization (Week 24).|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||percentage of participants|||Number
157856|NCT00310466|Primary|Daily Rhinoconjunctivitis Rescue Medication Score|Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).|Birch pollen season 2006|||Units on a scale (0-30)||Standard Deviation|Mean
157760|NCT00311363|Secondary|Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. LOCF: Missing data (MD) values were imputed using the last non-missing observation prior to the visit with MD; randomization visit data could be carried forward.|Randomization (Week 24) and Week 36 (or end of DB treatment)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||points on a scale||Standard Deviation|Mean
157761|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase)|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 184 to 252 (Weeks 26 to 36)|DB ITT Population|||||
157762|NCT00311363|Secondary|Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period|Time to relapse was defined as the time until worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week Double-blind (DB) treatment period (same as primary outcome definition). Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event. The median is not estimable for this outcome.|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|DB ITT Population|||||
157763|NCT00311363|Primary|Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period|"Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 [Week 24] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of much worse or very much worse on the investigator-rated Clinical Global Impression of Change (CGI-C)."|DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)|Double-blind Intent-to-Treat (DB ITT) Population: all participants who were randomized into the study, received at least one dose (or any portion of dose) of DB study drug, and for whom at least one post-Randomization visit (Week 24) IRLS Scale total score and investigator-rated CGI-C was available. One participant did not satisfy this description.||percentage of participants|||Number
157764|NCT00311311|Secondary|Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline, and 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||mmˆ3/year||Standard Deviation|Mean
157765|NCT00311311|Secondary|Number of Participants Who Used Anti-hypertensive Medications|"Participants who reported yes for taking anti-hypertensive medications as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||participants|||Number
157766|NCT00311311|Secondary|Number of Participants Who Used Lipid Lowering Therapies|"Participants who reported yes for taking lipid lowering therapies as concomitant medication."|From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||participants|||Number
157767|NCT00311311|Secondary|Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant|Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|Two types of folate tests were used: serum folate and red blood cell (RBC) folate. The tests were not consistent across sites. Therefore, the evaluation was not analyzed.|||||
157768|NCT00311311|Secondary|Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant|Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points||µmol/L||Standard Deviation|Mean
157769|NCT00311311|Secondary|Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant|Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points||pmol/L||Standard Deviation|Mean
157770|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant|Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||gram per liter (g/L)||Standard Deviation|Mean
157860|NCT00310440|Secondary|Kyphosis|Kyphosis is evaluated in degrees.|12 months|Per protocol (PP) subjects who had images available at 12 months were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||degrees||Standard Deviation|Mean
157774|NCT00311311|Secondary|Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant|Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point||pg/mL||Standard Deviation|Mean
157775|NCT00311311|Secondary|Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant|TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||pg/mL||Standard Deviation|Mean
157776|NCT00311311|Secondary|Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.|hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||mg/L||Standard Deviation|Mean
157777|NCT00311311|Secondary|Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant|Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||microgram per milliliter (µg/mL)||Standard Deviation|Mean
157778|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant|HbA1C, change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at the specific time point||percentage of glucose||Standard Deviation|Mean
157779|NCT00311311|Secondary|Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant|Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||picomole/liter (pmol/L)||Standard Deviation|Mean
157780|NCT00311311|Secondary|Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant|Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.|Pre-conversion baseline, 12, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||mmol/L||Standard Deviation|Mean
157781|NCT00311311|Secondary|Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant|Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||millimole/liter (mmol/L)||Standard Deviation|Mean
157782|NCT00311311|Secondary|Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant|Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.|Pre-conversion baseline, 12, and 24 months post-transplant|Evaluation of carotid plaque roughness at pre-conversion baseline, and at 12 and 24 months post-transplant was planned in the study design, however during the study conduct, it was removed as a cardiovascular endpoint since it was not validated.|||||
157783|NCT00311311|Secondary|CIMT at Pre-conversion Baseline|Mean CIMT=average of left CIMT and right CIMT.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline||mm||Standard Deviation|Mean
157784|NCT00311311|Secondary|Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant|Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit – CIMT at Conversion Baseline) / Imaging interval in years.|Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant|On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point||millimeter/year (mm/year)||Standard Deviation|Mean
157785|NCT00311311|Primary|TPV at Pre-conversion Baseline|TPV is the sum of the assessment in left and right distal common carotid arteries.|Pre-conversion baseline|On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline||mmˆ3||Standard Deviation|Mean
157786|NCT00311311|Primary|Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant|Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.|Pre-conversion baseline and 12 months post-transplant|On-Therapy Population: includes all intent-to-treat (ITT) subjects who also remained on assigned therapy until 12 months post-transplant for the primary endpoint, or until 36 months post-transplant for the cardiovascular and safety endpoints; N=number of evaluable participants for the outcome measure at 12 months post-transplant||millimeter cube/year (mmˆ3/year)||Standard Deviation|Mean
157787|NCT00311181|Primary|DFT (4.5 ms Waveform)||Implant|||Volts||Standard Error|Mean
157788|NCT00311181|Primary|DFT (2.5 ms Waveform)||Implant|||Volts||Standard Error|Mean
157789|NCT00311181|Primary|Defibrillation Thresholds (DFTs) (3.5 ms Waveform)||Implant|||Volts||Standard Error|Mean
157970|NCT00308737|Secondary|Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM|Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM|Baseline to Month 24|participants in ITT population with available data||mL/min/mmHg||Standard Deviation|Mean
157790|NCT00311155|Secondary|Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||mm Hg||Standard Deviation|Mean
157791|NCT00311155|Secondary|Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment||Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||mm Hg||Standard Deviation|Mean
157792|NCT00311155|Secondary|Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Systolic responders defined as a participant who is a normaliser or has a lowering of the mean sitting systolic blood pressure of ≥20 mmHg at trough|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of Participants|||Number
157793|NCT00311155|Secondary|Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.|Diastolic responders were defined as a participant who is a normaliser or has a lowering of the mean sitting diastolic blood pressure of ≥10 mmHg at trough.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of participants|||Number
157794|NCT00311155|Secondary|Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved|Normalized blood pressure is defined as a mean sitting systolic blood (sBP) pressure at trough of <140 mmHg and mean sitting diastolic blood pressure (dBP)of <90 mmHg for non-diabetic patients or a mean sitting sBP at trough of <130 mmHg and mean sitting dBP <80 mmHg for diabetic patients.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of participants|||Number
157795|NCT00311155|Primary|The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.|For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - <130 mm Hg; Diastolic - <80 mm Hg.|Baseline to ≤20 weeks|691 = the full analysis set (FAS). FAS consists of all participants who received trial medication and who had data from at least one post-baseline visit with regard to the primary efficacy parameter, i.e., both the systolic and the diastolic blood pressure (BP) had to be measured. N is reduced for each treatment as subjects attain BP goals.||Percentage of participants|||Number
157796|NCT00310856|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination|The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination|From day 1 through day 7 after any vaccination|Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data.||Number of subjects|||Number
157797|NCT00310856|Secondary|hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
157798|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age|Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
157799|NCT00310856|Secondary|hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
157800|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age|Before and 1 month after MenACWY-CRM vaccination at 18 months|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
157971|NCT00308737|Secondary|Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM|Change from baseline to Month 24 in TLC by MMRM|Baseline to Month 24|participants in ITT population with available data||liters||Standard Deviation|Mean
157801|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
157802|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age|Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age|Before and 1 month after MenC-CRM vaccination at 12 months|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
157803|NCT00310856|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.||Percentage of subjects||95% Confidence Interval|Number
157804|NCT00310856|Secondary|Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on PP population.||Geometric mean titers||95% Confidence Interval|Geometric Mean
157805|NCT00310856|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule|Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)|Before and 1 month after 2-dose or 1-dose schedule|Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.||Percentage of subjects||95% Confidence Interval|Number
157806|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician’s visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.|28 days after first vaccination and 21 days after second vaccination|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.||Subjects|||Number
157807|NCT00310817|Secondary|Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|From day 1 through day 7 after first or second vaccination(s)|Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.||Subjects|||Number
157808|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157809|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157810|NCT00310817|Secondary|hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|12 months after second vaccination|Analysis was done on PP dataset Immunogenicity of a booster dose - subset of subjects in the MITT population who received a booster dose of either MenACWY Ad+/Ad- conjugate vaccine, and provided evaluable serum samples at day 169, 358 & had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
157857|NCT00310466|Secondary|Adverse Events|An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).|Birch pollen season 2006|||Events|||Number
157811|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157812|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157813|NCT00310817|Secondary|hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination|||titers||95% Confidence Interval|Geometric Mean
157814|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157815|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+ / Ad- conjugate vaccine who received a booster dose of either Novartis MenACWY Ad+/ Ad- conjugate vaccine, provided evaluable serum samples at day 169 and 358, had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157816|NCT00310817|Secondary|hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age|Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
157817|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
157818|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157819|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157858|NCT00310466|Secondary|Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects|The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).|Birch pollen season 2006|||Participants|||Number
157820|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157821|NCT00310817|Secondary|hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
157822|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age|Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157823|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|21 days after the second vaccination|Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157824|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY–CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-)vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157825|NCT00310817|Secondary|hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age|Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.|21 days after second vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
157826|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subjects in the MITT who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-) or MenACWY-PS vaccine at either 6 or 12 months from the 1st vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the 1st vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157827|NCT00310817|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY(Ad-) vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157828|NCT00310817|Secondary|hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.|6 months after first vaccination and 12 months after first vaccination|Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+/PS vaccine, provided evaluable serum samples at day 169 day 358 and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
157829|NCT00310817|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||titers||95% Confidence Interval|Geometric Mean
157830|NCT00310817|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination|Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157831|NCT00310817|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.|28 days after first vaccination.|Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.||percentages of subjects||95% Confidence Interval|Number
157832|NCT00310804|Secondary|Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.|Day 1 - Day 181 postvaccination|This analysis was done on safety dataset.||subjects|||Number
157833|NCT00310804|Secondary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV."|Day 1 to Day 7 postvaccination|Analysis was done on safety dataset.||subjects|||Number
157834|NCT00310804|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine|"Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after~one dose of cTIV for each of the three vaccine lots separately and~one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.~As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination."|Day 22 postvaccination|This analysis was done on PP population.||Percentages||95% Confidence Interval|Number
157835|NCT00310804|Primary|Percentage of Subjects With HI Titers ≥40|"Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%."|Day 22 postvaccination|This analysis was done on PP population.||Percentages||95% Confidence Interval|Number
157836|NCT00310804|Primary|Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following~one dose of cTIV for each of the three vaccine lots separately and~for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.~The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5."|Day 22 postvaccination|The analysis was performed as PP dataset.||Ratio||95% Confidence Interval|Geometric Mean
157837|NCT00310804|Primary|Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects|"The haemagglutinin Inhibition (HI) antibody titer response following~one dose of cTIV for each of the three lots separately and~one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).~The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|This analysis was done on per protocol (PP) population defined as all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.||Titers||95% Confidence Interval|Geometric Mean
157838|NCT00310791|Primary|Areal Bone Density by DXA||18-Months|||g/cm2||Standard Deviation|Mean
157839|NCT00309985|Secondary|QOL Change From Baseline to 3 Months|The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy – Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.|Assessed at baseline and 3 months|Patients with both baseline and 3-month QOL assessments are included in this analysis.||units on a scale||Standard Error|Mean
157972|NCT00308737|Secondary|Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM|Change from Baseline to Month 24 in FVC by MMRM|Baseline to Month 24|Intention to Treat (ITT)||liters||Standard Deviation|Mean
157840|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 12 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.|Assessed at 12 months|All randomized patients||proportion of participants||95% Confidence Interval|Number
157841|NCT00309985|Secondary|Proportion of Patients With PSA Complete Response (CR) at 6 Months|PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.|Assessed at 6 months|All randomized patients||proportion of participants||95% Confidence Interval|Number
157842|NCT00309985|Secondary|Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)|Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.||months||95% Confidence Interval|Median
157843|NCT00309985|Secondary|Time to Clinical Progression|Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients.||months||95% Confidence Interval|Median
157844|NCT00309985|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry|All randomized patients||months||95% Confidence Interval|Median
157845|NCT00309946|Secondary|Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity|Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.|Week 1 of course 1|This outcome was not measured/assessed for any of the study subjects.|||||
157846|NCT00309946|Secondary|Changes in Laboratory Correlates|Examined using paired t-test or Wilcoxon signed-ranks test.|Baseline, days 15 and 29 of course 1, and then every 28 days|This outcome was not measured/assessed for any of the study subjects.|||||
157847|NCT00309946|Primary|Objective Response Rate, Complete (CR) or Partial (PR) Response|Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.|Every 8 weeks|||percentage of participants|||Number
157848|NCT00309907|Secondary|C-reactive Protein Levels|Measurements will be summarized with mean and standard deviations for subgroups of subjects (those who respond versus non-responders). Two group comparisons of CRP (C-reactive protein) levels (responders versus non-responders) will likely be underpowered, and such comparisons will be done to generate hypotheses for future studies.|From baseline to days 7, 14, 21, and 28||||||
157849|NCT00309907|Secondary|Levels of Pro-inflammatory Cytokines, in Both BAL (Bronchoalveolar Lavage) Fluid and Serum as Assessed by Enzyme-linked Immunosorbent Assays|Measurements will be summarized with means and standard deviations for subgroups of subjects (e.g. responders versus non-responders). Two-group comparisons of cytokines (e.g. responders versus non-responders) will likely be underpowered, and such comparisons will be done only to generate hypotheses for future studies. Comparative plasma cytokine assays will be performed in a similar fashion as that of the BAL fluid.|From baseline to days 7 and 56||||||
157850|NCT00309907|Secondary|Toxicity of Etanercept Plus Corticosteroid Therapy Using the Common Terminology Criteria Version 4.0||Up to 56 days||||||
157851|NCT00309907|Secondary|Time to Discontinuation of Supplemental Oxygen Support|"The time required to discontinue supplemental oxygen will be measured in the number of days from study entry till the patient is on room air and will be estimated using the cumulative incidence estimator due to the competing risk of death."|Time from study to time on room air, assessed up to 56 days||||||
157852|NCT00309907|Secondary|Survival Rate||From the first dose of treatment with etanercept to the date of last follow up or date of death, assessed up to 56 days||||||
157853|NCT00309907|Primary|Response of IPS (Idiopathic Pneumonia Syndrome) to Etanercept Plus Corticosteroid Therapy by Day 28.|Response to therapy is defined as survival to Day 28 of study, PLUS complete discontinuation all supplemental oxygen support by Day 28 of study. Subjects must be able to remain off all supplemental oxygen support for > 72 consecutive hours. Subjects who discontinue supplemental oxygen within the last 72 hours of the observation period will be followed until they have completed 72 consecutive hours off oxygen or failed prior to assessing response.|At day 28|Analysis population includes all patients who are eligible and had sufficient data to evaluate response. Eleven ineligible patients are excluded.||participants|||Number
157854|NCT00309777|Secondary|National Cholesterol Education Program (NCEP) LDL-C Target Attainment|Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12|12 week|Full Analysis Set||Participants|||Number
157855|NCT00309777|Primary|Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks|Baseline to 12 weeks|||Percent change||Standard Deviation|Mean
159088|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52||Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.||mg/L||Full Range|Geometric Mean
157861|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score – PCS) and one for mental health (Mental Composite Score – MCS) that are comprised of eight domains. The following domains make up the MCS: vitality, social functioning, role-emotional, mental health. The MCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||score on a scale||95% Confidence Interval|Least Squares Mean
157862|NCT00310440|Secondary|Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).|The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score – PCS) and one for mental health (Mental Composite Score – MCS) that are comprised of eight domains. The following domains make up the PCS: physical functioning, role-physical, bodily pain, general health. The PCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||units on a scale||95% Confidence Interval|Least Squares Mean
157863|NCT00310440|Secondary|Success Rates Measured by Aggregated Modified Odom's Criteria|Subjects selected one of four categories: Excellent (Improvement Greater than or Equal to 80%, Deterioration Less than 10%), Good (Improvement Greater than or Equal to 70%, Deterioration Less than 15%), Fair (Improvement Greater than or Equal to 50%, Deterioration Less than 20%) or Poor (Improvement Less than 50%, Deterioration Greater than 20%).|12 months|Per protocol (PP) subjects that had data available at the 12 month visit were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||participants|||Number
157864|NCT00310440|Secondary|Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||cm||95% Confidence Interval|Mean
157865|NCT00310440|Secondary|Mean Change in Pain at Neck Visual Analog Scale (VAS).|"The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from No pain at all (0) to Worst imaginable pain (10). The change in pain is calculated by subtracting the 12 month score from the baseline score."|Baseline and 12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||cm||95% Confidence Interval|Mean
157866|NCT00310440|Primary|Complications|Any AE within 12 months of surgery.|12 months|All enrolled subjects.||participants|||Number
157867|NCT00310440|Primary|Neurologic Success|The neurological endpoint is a binary variable. Neurologic success was assessed in the motor, sensory and reflex domains specific for the cervical spine as follows: maintenance or improvement of motor function in the elbow flexors (i.e. biceps muscle), elbow extensors (i.e. triceps muscle) and wrist extensors of both arms; maintenance or improvement of sensory function of both arms; maintenance or improvement of reflexes of both arms as measured at biceps tendon, triceps tendon and brachioradialis (supinator) reflex AND absence of Babinski reflex (if not present prior to surgery). Worsening of neurological status (neurological failure) was defined as a permanent decline in the subject's neurological status based on adjudication of accumulated neurological data by an independent blinded evaluator.|12 months|The total number of observed subjects.||participants|||Number
157868|NCT00310440|Primary|Change in of the Overall Neck Disability Index (NDI) Score From Baseline.|The NDI consists of ten items addressing functional activities (personal care, lifting, reading, work, driving, sleeping, recreational activities), pain intensity, concentration and headache. For each item, there are six potential responses, describing increasing degrees of disability (no disability = 0 to total disability = 5). An overall NDI score, out of 100, is calculated by adding up the scores for each item and multiplying by two. A higher NDI score indicates greater disability.|12 months|Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.||units on a scale||95% Confidence Interval|Least Squares Mean
157869|NCT00310440|Primary|Radiologic Fusion|Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion <3mm, and angular motion <5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and bridging bone formation that crosses the interspace.|12 months|All participants that have radiological data at 12 months including imputed data.||participants|||Number
157870|NCT00310427|Primary|Craving for Alcohol Evoked by Alcohol-cue Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 4|||Units on a scale||Standard Error|Mean
157871|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 2 minus baseline|||Units on a scale||Standard Error|Mean
157872|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 3, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 3 Rating 1 minus baseline|||Units on a scale||Standard Error|Mean
157873|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 2 minus baseline|||Units on a scale||Standard Error|Mean
157874|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 2, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 2 Rating 1 minus baseline|||Units on a scale||Standard Error|Mean
157875|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the Second of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1 Rating 2 minus baseline|||Units on a scale||Standard Error|Mean
157876|NCT00310427|Primary|Change From Baseline in Spontaneous Alcohol Craving at Week 1, During the First of Two Weekly Ratings.|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Week 1/Rating 1 minus baseline|||Units on a scale||Standard Error|Mean
157877|NCT00310427|Primary|Craving for Alcohol (Spontaneous)|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). This is a self-report rating scale, with scores ranging from 8 (lowest craving value) to 56 (highest craving value).|Baseline|||Units on a scale||Standard Error|Mean
157878|NCT00310401|Secondary|Chest X-ray Findings||72 hours||||||
157879|NCT00310401|Secondary|Pulmonary Vascular Resistance||72 hours||||||
157880|NCT00310401|Secondary|Lung Compliance||72 hours||||||
157881|NCT00310401|Secondary|Donor Lung Utilization||72 hours||||||
157882|NCT00310401|Primary|Donor Oxygenation|The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement|72 hours or less|||cmH2O||Inter-Quartile Range|Median
157883|NCT00310375|Secondary|Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire|The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Assessed up to a maximum of 9 years|Safety Population||Scores on a scale||Standard Deviation|Mean
157884|NCT00310375|Secondary|Percentage of Seizure-free Days|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days|Assessed up to a maximum of 9 years|Safety Population||Percentage of days||Standard Deviation|Mean
157885|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 12 Continuous Months|Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157886|NCT00310375|Secondary|Number of Participants Who Were Seizure Free for Any 6 Continuous Months|Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157887|NCT00310375|Secondary|Number of Responders|A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157888|NCT00310375|Secondary|Percentage Change From Baseline in the 28-day Partial Seizure|Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Percent change||Standard Deviation|Mean
157889|NCT00310375|Primary|Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination|Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157890|NCT00310375|Primary|Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination|A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157891|NCT00310375|Primary|Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa|An assessment of the participant’s nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157892|NCT00310375|Primary|Number of Participants With Pigmentation of Retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157893|NCT00310375|Primary|Number of Participants With Pigmentation of Non-retinal Ocular Tissue|The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.|Assessed up to a maximum of 9 years|Safety Population||Participants|||Number
157894|NCT00310375|Primary|Number of Participants With Abnormal Results of Neurological Examination|Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Month 108|Safety Population||Participants|||Number
157895|NCT00310375|Primary|Number of Participants With Abnormal Results in Physical Examination|A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category|Up to Month 108|Safety Population||Participants|||Number
157896|NCT00310375|Primary|Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score|An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant’s urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population||Scores on a scale||Standard Deviation|Mean
157897|NCT00310375|Primary|Change From Baseline in Post-void Residual Bladder Ultrasound Volume|Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population||Milliliter (mL)||Standard Deviation|Mean
157898|NCT00310375|Primary|Change From Baseline in Urine Power of Hydrogen (pH)|Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||pH units||Standard Deviation|Mean
157899|NCT00310375|Primary|Change From Baseline in Urine Specific Gravity|Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Dimensionless unit||Standard Deviation|Mean
157900|NCT00310375|Primary|Change From Baseline in Chemistry Parameter-Total Protein|Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline and Up to Month 108|Safety Population||Grams per liter (g/L)||Standard Deviation|Mean
157901|NCT00310375|Primary|Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA)|Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Micromole per Liter (umol/L)||Standard Deviation|Mean
157911|NCT00310375|Primary|Change From Baseline in Weight|Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Kilograms||Standard Deviation|Mean
157902|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea|Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Millimole per liter (mmol/L)||Standard Deviation|Mean
157903|NCT00310375|Primary|Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)|Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||International units per litre (IU/L)||Standard Deviation|Mean
157904|NCT00310375|Primary|Change From Baseline in Haemoglobin|Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population||Grams/Liter (g/L)||Standard Deviation|Mean
157905|NCT00310375|Primary|Change From Baseline in Haematocrit|Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population||Volume/Volume (v/v)||Standard Deviation|Mean
157906|NCT00310375|Primary|Change From Baseline in Hematology Parameter-Red Blood Cell Count|Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..|Baseline and Up to Month 108|Safety Population||10^12 cells/Liter(L)||Standard Deviation|Mean
157907|NCT00310375|Primary|Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)|Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||10^9 cells/Liter||Standard Deviation|Mean
157908|NCT00310375|Primary|Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population||Degree||Standard Deviation|Mean
157909|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Up to Month 108|Safety Population||Seconds (sec)||Standard Deviation|Mean
157910|NCT00310375|Primary|Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF)|A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Milliseconds (msec)||Standard Deviation|Mean
157912|NCT00310375|Primary|Change From Baseline in Body Temperature|Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available|Baseline and Up to Month 108|Safety Population||Degree Celsius||Standard Deviation|Mean
157913|NCT00310375|Primary|Change From Baseline in Heart Rate|Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Beats per Minute||Standard Deviation|Mean
157914|NCT00310375|Primary|Change From Baseline in Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.|Baseline and Up to Month 108|Safety Population||Millimeter of mercury (mmHg)||Standard Deviation|Mean
157915|NCT00310375|Primary|Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug|The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn’t switch to commercial product were counted as “events”. Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title).|Assessed up to a maximum of 9 years|Safety Population||Percentage Probability of d/c|||Number
157916|NCT00310375|Primary|Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug|Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population||Participants.|||Number
157917|NCT00310375|Primary|Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.|Assessed up to a maximum of 9 years|Safety Population included all participants who took at least 1 dose of study medication||Participants|||Number
157918|NCT00310362|Secondary|Preparation Non-adherence-flexible Sigmoidoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the flexible sigmoidoscopy procedure.|3 months||||||
157919|NCT00310362|Secondary|Preparation Nonadherence-colonoscopy|Preparation nonadherence assessed whether patients had adequately prepared to complete the colonoscopy procedure.|3 months||||||
157920|NCT00310362|Secondary|Nonattendance-flexible Sigmoidoscopy|Nonattendance was defined as canceling the flexible sigmoidoscopy appointment or not attending the appointment|3 months||||||
157921|NCT00310362|Primary|Appointment Nonadherence-colonoscopy|Nonattendance was defined as canceling the colonoscopy appointment or not attending the appointment|3 months|||nonadherent participants|||Number
157922|NCT00310076|Secondary|Toxicity||24 months||||||
157923|NCT00310076|Primary|Progression Free Survival||60 months after treatment|||years||95% Confidence Interval|Median
157924|NCT00309751|Secondary|Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target|Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks|12 weeks|||Participants|||Number
157925|NCT00309751|Primary|Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)|Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)|12 weeks|||percent change||Standard Deviation|Mean
157926|NCT00309738|Secondary|Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)|Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)|12 weeks|Full analysis set (FAS)||participants|||Number
157927|NCT00309738|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)|12 weeks|Subjects who completed the treatment period||mg/dL||Standard Deviation|Mean
157928|NCT00309608|Secondary|Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.||mg/dL||Standard Error|Mean
157930|NCT00309608|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.||Percent||Standard Error|Mean
157931|NCT00309465|Primary|Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery|Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.|Day 1|Percentage of subjects that achieved preoperative blood glucose value of 100-179 mg/dl and 80-249 mg/dl. Analyses were by intention to treat.||Percentage of subjects|||Number
157932|NCT00309452|Secondary|Economic Measures Including Service Use, Cost of Care and Forensic Data.|Total annual cost per patient|every 6 months|||dollars||Standard Error|Mean
157933|NCT00309452|Secondary|Medication (Including Metabolic) Side Effects||every 6 months|data no collected|||||
157934|NCT00309452|Secondary|Subjects Who Committed Self-harm and Violence|The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.|12 months|This data was collected, numbers reflect actual data.||participants|||Number
157935|NCT00309452|Secondary|Substance Use||every 6 months|This was not a planned primary or secondary outcome in our analysis (though collected at baseline) and because of significant attrition we did not report on this outcome despite having phone call f/u data on other outcomes. We did not believe phone reports on this outcome would produce reliable data.|||||
157936|NCT00309452|Secondary|Adherence- in Contact With Mental Health Services|Number of participants in contact with mental health services. Collected via self-report.|1 year|Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm.||participants|||Number
157937|NCT00309452|Secondary|Treatment Satisfaction||every 6 months|Data was not collected|||||
157938|NCT00309452|Secondary|Vocationally Engaged||1 year after enrollment|20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up.||participants|||Number
157939|NCT00309452|Secondary|Quality of Life- Heinrich's Quality of Life Scale|"The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126.~The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health."|12 months|||units on a scale||Standard Deviation|Mean
157940|NCT00309452|Secondary|Overall Functioning- Global Assessment of Functioning|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning.~The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning."|12 months|||units on a scale||Standard Deviation|Mean
157941|NCT00309452|Secondary|Relapse|Data was not collected, instead Hospitalization (primary outcome) was used as a proxy|every 6 months||||||
157942|NCT00309452|Primary|Number of Patients Hospitalized||1 year after enrollment|||participants|||Number
157943|NCT00309387|Secondary|Number of Participants With a Decrease in Visual Acuity|Number of participants with a decrease in best corrected visual acuity score from baseline of > 15 letters in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat||participants|||Number
157944|NCT00309387|Secondary|Number of Participants Undergoing Cataract Surgery|number of participants undergoing cataract surgery in at least one eligible eye during follow-up|at 6 month intervals from baseline for approximately 10 yrs|intention to treat||participants|||Number
157945|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Posterior Subcapsular Opacities|Number of participants with a 5% increase in area of posterior subcapsular opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat||participants|||Number
157946|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Cortical Lens Opacities|Number of participants with a 10% increase in area of cortical opacity within a standard central 5 mm circle of the lens from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat||participants|||Number
157947|NCT00309387|Secondary|Number of Participants Showing Development or Progression of Nuclear Lens Opacities|number of participants with a 1.5 U increase in nuclear opalescence from baseline in at least one eligible eye during follow-up|at yearly intervals from baseline for approximately ten years|intention to treat||participants|||Number
157948|NCT00309387|Primary|Number of Participants Showing Development or Progression of Age-related Cataract or Undergoing Cataract Surgery During Follow-up|number of participants in whom any of the following occur in at least one eligible eye during follow-up: cataract surgery; nuclear opacity: a 1.5 U increase in opalescence from baseline; cortical opacity: a 10% increase in area within a standard 5 mm circle area of the lens from baseline; posterior subcapsular opacity: a 5% increase in area within a standard 5 mm circle area of the lens from baseline.|at yearly intervals from baseline for approximately ten years|Intention to treat analysis||participants|||Number
157949|NCT00309244|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population||Number of events/100 subject-months|||Number
157950|NCT00309244|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|52 Weeks|Safety Population||Number of events/subject-month|||Number
157973|NCT00308737|Secondary|Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care|Change from Baseline to last measurement(Month 24) in FEV1|Baseline to Month 24|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)||liters||95% Confidence Interval|Least Squares Mean
157951|NCT00309244|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|52 Weeks|Safety Population||percentage of participants|||Number
157952|NCT00309244|Secondary|Incidence of Total Hypoglycemia|Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.|52 Weeks|Safety Population||percentage of participants|||Number
157953|NCT00309244|Secondary|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%||Week 52|Intention to treat (ITT); participants with available data at baseline and Week 52.||participants|||Number
157954|NCT00309244|Secondary|Change From Baseline in Fasting Plasma Glucose to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.||milligrams per deciliter||Standard Error|Least Squares Mean
157955|NCT00309244|Secondary|Change From Baseline in Weight to Week 52||Baseline to Week 52|Intention to treat (ITT) population; participants with available data at baseline and Week 52.||kilogram||Standard Error|Least Squares Mean
157956|NCT00309244|Primary|Change From Baseline in HbA1c to Week 52||Baseline to Week 52|Intention to treat (ITT) with Last Observation Carried Forward (LOCF); participants with available data at baseline and post-baseline.||percent||Standard Error|Least Squares Mean
157957|NCT00308997|Secondary|Clinical Global Improvement (CGI)Improvement|"CGI score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The range for this score is from 1 to 7.~Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
157958|NCT00308997|Secondary|Change in Total Auditory Hall Rating Scale (AHRS) Score|"Total AHRS score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The score range is from 0-42. This is reported as a difference score and a higher score is an improvement.~Total AHRS score is measured as change relative baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
157959|NCT00308997|Secondary|Change in Hallucination Frequency|"AHRS frequency scale score assessed after 15 sessions, 16 minutes per session, of both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation (3 weeks). For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable. The hallucination frequency range is from 0-9. The scores reported are difference scores, and an improvement is a higher score.~Hallucination frequency is one of the variables incorporated into the AHRS (Auditory Hallucinations Rating Scale). The score is measured as change relative to baseline (i.e., baseline minus endpoint). Larger (positive) scores correspond to greater improvement."|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
157960|NCT00308997|Primary|Hallucination Change Score (HCS)|"HCS score assessed after 15 sessions, 16 minutes per session, delivered to both right superior temporal and left superior temporal gyrus sites using either rTMS or sham stimulation. For patients dropping out of the trial prematurely, last-observation-carried-forward data were used for this outcome variable.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 15 sessions of rTMS|Subjects who did not complete the intervention were excluded from the analysis||units on a scale||Standard Deviation|Mean
157961|NCT00308997|Primary|Hallucination Change Score - Left (HCS-left)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the left superior temporal gyrus.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not included in the analysis||units on a scale||Standard Deviation|Mean
157962|NCT00308997|Primary|Hallucination Change Score - Right (HCS-right)|"HCS score for participants assessed after 5 sessions, 16 minutes per session, who received either rTMS or sham stimulation delivered to the right superior temporal gyrus.~HCS was anchored at 0 (corresponding to no AVHs), 10 (no change in hallucination severity) and 20 (AVHs twice as severe as baseline). Lower scores correspond to greater improvement"|After 5 sessions of rTMS|Subjects who did not complete the intervention were not analyzed||units on a scale||Standard Deviation|Mean
157963|NCT00308737|Primary|FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care|FEV1 decrease of ≥ 15% from Baseline value at last measurement|Baseline to Month 24|Intention to Treat (ITT)||Participants|||Number
157964|NCT00308737|Secondary|Change in Weight From Baseline at Month 24|Change from baseline in weight at Month 24|Baseline to Month 24|Safety population at Month 24||kilograms||Standard Deviation|Mean
157965|NCT00308737|Secondary|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care|Change from baseline in HbA1c at last measurement|Baseline to Month 24|Intention to treat (ITT) with last observation carried forward (LOCF)||percentage||Standard Deviation|Mean
157966|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data||Participants|||Number
157967|NCT00308737|Secondary|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement|Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement|Baseline to Month 24|participants in ITT population with available data||Participants|||Number
157978|NCT00308711|Secondary|Minutes to Onset of Active Labor|Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.|2880 minutes|||minutes||Standard Deviation|Mean
157979|NCT00308711|Secondary|Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert|Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.|12 hours|||Percentage of Participants|||Number
157980|NCT00308711|Secondary|Percentage of Participants With Pre-Delivery Oxytocin Use|Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.|2880 minutes|This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery.||Percentage of participants|||Number
157981|NCT00308711|Secondary|Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events|"This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the Maternal/Fetal period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods."|96 hours|Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina.||Percentage of participants|||Number
157982|NCT00308711|Primary|Percentage of Participants With a Cesarean Section Delivery|Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.|2880 minutes|||Percentage of participants|||Number
157983|NCT00308711|Primary|Minutes From Drug Insertion to Vaginal Delivery|Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.|2880 minutes|This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate.||minutes||95% Confidence Interval|Median
157984|NCT00308620|Secondary|Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks|The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.|8 weeks|Analysis of Chloroquine arms is pooled.||percentage change||Full Range|Median
157985|NCT00308620|Primary|HIV Viral Load Change|HIV-1 viral load change between baseline and 8 weeks|baseline and 8 weeks|||log10 copies/mL||Standard Deviation|Log Mean
157986|NCT00308581|Secondary|CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.|Last visit on or before Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
157987|NCT00308581|Secondary|CRP Level at Week 26 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
157988|NCT00308581|Secondary|CRP Level at Week 24 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
157989|NCT00308581|Secondary|CRP Level at Week 22 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 22 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
157990|NCT00308581|Secondary|CRP Level at Week 20 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
157991|NCT00308581|Secondary|CRP Level at Week 18 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 18 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
157992|NCT00308581|Secondary|CRP Level at Week 16 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
157993|NCT00308581|Secondary|CRP Level at Week 14 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 14 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
157994|NCT00308581|Secondary|CRP Level at Week 12 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
157995|NCT00308581|Secondary|CRP Level at Week 10 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 10 (optional measurement)|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)||mg/L||Inter-Quartile Range|Median
157996|NCT00308581|Secondary|CRP Level at Week 8 in the Randomized Maintenance Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||mg/L||Inter-Quartile Range|Median
157997|NCT00308581|Secondary|CRP Level at Week 6 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
157998|NCT00308581|Secondary|CRP Level at Week 4 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
157999|NCT00308581|Secondary|CRP Level at Week 2 of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
158000|NCT00308581|Secondary|C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase|High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.|Week 0|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||mg/L||Inter-Quartile Range|Median
158001|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 26|ITTR population taking steroids at baseline||participants|||Number
158002|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 24|ITTR population taking steroids at baseline||participants|||Number
158003|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 22|ITTR population taking steroids at baseline||participants|||Number
158004|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 20|ITTR population taking steroids at baseline||participants|||Number
158005|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 18|ITTR population taking steroids at baseline||participants|||Number
158006|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 16|ITTR population taking steroids at baseline||participants|||Number
158007|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 14|ITTR population taking steroids at baseline||participants|||Number
158008|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 12|ITTR population taking steroids at baseline||participants|||Number
158009|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).|Week 10|ITTR population taking steroids at baseline||participants|||Number
158010|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 26|ITTR population taking steroids at baseline||participants|||Number
158011|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 24|ITTR population taking steroids at baseline||participants|||Number
158012|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 22|ITTR population taking steroids at baseline||participants|||Number
158013|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 20|ITTR population taking steroids at baseline||participants|||Number
158014|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 18|ITTR population taking steroids at baseline||participants|||Number
158015|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 16|ITTR population taking steroids at baseline||participants|||Number
158016|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 14|ITTR population taking steroids at baseline||participants|||Number
158017|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 12|ITTR population taking steroids at baseline||participants|||Number
158018|NCT00308581|Secondary|Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.|Remission is defined as CDAI score ≤ 150.|Week 10|ITTR population taking steroids at baseline||participants|||Number
158019|NCT00308581|Other Pre-specified|Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6|Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.|Week 6 to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||days||Full Range|Median
158020|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158021|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158022|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158023|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158024|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158025|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158026|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158027|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158028|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158185|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48|Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline.|48 Weeks|RAT Analysis Set Non-Completers=Failure||participants|||Number
158029|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158030|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
158031|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
158032|NCT00308581|Secondary|Change From Baseline in CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
158033|NCT00308581|Secondary|CDAI Score at Week 26 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158034|NCT00308581|Secondary|CDAI Score at Week 24 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 24|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158035|NCT00308581|Secondary|CDAI Score at Week 22 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 22|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158036|NCT00308581|Secondary|CDAI Score at Week 20 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 20|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158037|NCT00308581|Secondary|CDAI Score at Week 18 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 18|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158038|NCT00308581|Secondary|CDAI Score at Week 16 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 16|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158039|NCT00308581|Secondary|CDAI Score at Week 14 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 14|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158040|NCT00308581|Secondary|CDAI Score at Week 12 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 12|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158041|NCT00308581|Secondary|CDAI Score at Week 10 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 10|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158042|NCT00308581|Secondary|CDAI Score at Week 8 in the Randomized Maintenance Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 8|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)||points on a scale||Standard Deviation|Mean
158043|NCT00308581|Secondary|CDAI Score at Week 6 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
158044|NCT00308581|Secondary|CDAI Score at Week 4 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 4|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
158045|NCT00308581|Secondary|CDAI Score at Week 2 of the Induction Phase|The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 2|ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)||points on a scale||Standard Deviation|Mean
158046|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase||participants|||Number
158047|NCT00308581|Secondary|Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase|Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|ITTI population: subjects who received at least one dose of study drug in the induction phase||participants|||Number
158048|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase||participants|||Number
158049|NCT00308581|Secondary|Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase|Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 6|ITTI population: all subjects who received at least one dose of study drug in the induction phase||participants|||Number
158050|NCT00308581|Secondary|Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase|Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Week 26|Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase||participants|||Number
158051|NCT00308581|Primary|Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase|"Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.~The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity."|Baseline to Week 6|Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase||participants|||Number
158052|NCT00308555|Primary|Disposition Kinetics of Morphine and Oxycodone Before and After Cannabis Use|Pharmacokinetics are measured on Day 1, prior to cannabis use, and again on Day 5, following cannabis use on Days 2, 3, and 4.|Day 1, Day 5|The number was determined by the number of participants completing both Day 1 and Day 5 procedures.||Geometric Mean Ratio||95% Confidence Interval|Number
158053|NCT00308516|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months||||||
158054|NCT00308516|Primary|Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment|24 months|||percentage of participants||95% Confidence Interval|Number
158055|NCT00308308|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population||Number of events/subject-month|||Number
158056|NCT00308308|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 52|Safety Population||Number of events/subject-month|||Number
158057|NCT00308308|Secondary|Incidence of Severe Hypoglycemia|"Severe hypoglycemia occurs when all 3 of the following occur simultaneously:~Subject requires the assistance of another person;~Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);~Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,~Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms."|Baseline to Week 52|Safety Population||percentage of participants|||Number
158064|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and not using SU at screening.||events per subject-year||Standard Error|Mean
158065|NCT00308139|Secondary|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 364|ITT Population who participated in the 30-week assessment period and using SU at screening.||events per subject-year||Standard Error|Mean
158066|NCT00308139|Secondary|Ratio of Triglycerides at Week 364 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||95% Confidence Interval|Least Squares Mean
158067|NCT00308139|Secondary|Ratio of Triglycerides at Week 30 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||ratio||Standard Error|Least Squares Mean
158068|NCT00308139|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364|Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
158069|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
158070|NCT00308139|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30|Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
158071|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 364|Change in total cholesterol from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
158072|NCT00308139|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
158073|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 364|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364|Day -3, Week 364|7-Year Completer Population using observed data.||mmHg||Standard Deviation|Mean
158074|NCT00308139|Secondary|Change in Blood Pressure From Baseline to Week 30|Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30|Day -3, Week 30|ITT Population using observed data.||mmHg||Standard Error|Mean
158075|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 364|Change in fasting plasma glucose from baseline (Day -3) to Week 364.|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||95% Confidence Interval|Least Squares Mean
158076|NCT00308139|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 30|Change in fasting plasma glucose from baseline (Day -3) to Week 30.|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||mg/dL||Standard Error|Least Squares Mean
158077|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 364|Change in body weight from baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||95% Confidence Interval|Least Squares Mean
158078|NCT00308139|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight from baseline (Day -3) to Week 30|Day -3, Week 30|ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||kg||Standard Error|Least Squares Mean
158079|NCT00308139|Secondary|Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.|Week 22||||||
158080|NCT00308139|Secondary|Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14|Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14|Day -3, Week 14|Evaluable Meal Tolerance Cohort consisted of ITT subjects who participated in the meal tolerance test and had adequate data to allow the reliable assessment of pharmacodynamics. Only subjects with non-missing baseline and Week 14 values were included in analysis.||mg/dL||Standard Error|Least Squares Mean
158081|NCT00308139|Secondary|Exenatide LAR Steady State Concentration From Week 29 to Week 30|Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.|Week 29 to Week 30|The Pharmacokinetics Population consisted of subjects who received exenatide LAR treatment, and had adequate plasma exenatide concentration-time data to allow for reliable evaluation of exenatide LAR pharmacokinetics.||pg/mL||Inter-Quartile Range|Geometric Mean
158082|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.0%|Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
158083|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
158084|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
158085|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 364|Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
158086|NCT00308139|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentage of subjects achieving HbA1c target value of <7% at Week 30.|Week 30|ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.||percentage of subjects|||Number
158087|NCT00308139|Primary|Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)|Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval|Week 22||||||
158088|NCT00308139|Secondary|Change in HbA1c From Baseline to Week 364|Absolute change in HbA1c from Baseline (Day -3) to Week 364|Day -3, Week 364|7-Year Completer Population. Missing data up to Week 364 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||95% Confidence Interval|Least Squares Mean
158089|NCT00308139|Primary|Change in HbA1c From Baseline to Week 30|Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]|Day -3, Week 30|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.||percentage of total hemoglobin||Standard Error|Least Squares Mean
158090|NCT00308113|Secondary|Compare Side Effect Profiles of the Three Study Groups|To compare side effect profiles of the three regimens to the enhanced standard of care group, to include height, weight, weight/height ratio, body mass index, cataract formation, blood glucose, blood pressure, and behavioral changes.|12 months|No analysis was performed as the study was closed with N=3 out of 120 and side effects profile between groups could not be analyzed.|||||
158091|NCT00308113|Primary|One Year Change in Pulmonary Function (Forced Expiratory Volume, FEV1 and Forced Vital Capacity, FVC)|Comparing change from baseline levels in pulmonary function (FEV1 and FVC) in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year.|12 months|No analysis was performed as only 1 out of 3 participants completed all the pulmonary function measurements before the protocol was closed.|||||
158092|NCT00308113|Primary|One Year Change of Left Ventricular Mean Systolic Wall Stress/Rate-corrected Velocity of Fiber Shortening Relation.|Comparing change from baseline of mean systolic wall stress and rate-corrected mean velocity of circumferential shortening in the three treatment groups relative to the enhanced standard of care group and relative to each other at one year. The values are obtained via an echocardiogram read locally at each site.|12 months|No analysis was performed as only 1 out of 3 participants completed all echocardiogram measurements before the protocol was closed.|||||
158106|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
158093|NCT00308087|Secondary|Summary of Cost Effectiveness|A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.|24 months|No participants were analyzed because the study was terminated early due to low enrollment.|||||
158094|NCT00308087|Secondary|Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment|Count of days in which a participant experiences a Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.|24 months|Intent to treat population.||Days||Inter-Quartile Range|Median
158095|NCT00308087|Secondary|Kaplan-Meier Estimates of Progression-Free Survival|Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.|24 months|Intent to treat population||Days||Inter-Quartile Range|Median
158096|NCT00308087|Secondary|Participant Summary of Best Response Across All Visits|"Count of participants' best response within categories defined by the International Working Group (IWG):~> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),~> Complete Response Unconfirmed (unconfirmed complete disappearance),~> Partial Response (>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),~> Stable Disease (neither response nor disease progression),~> Progression (new lesion or increase by 50% of previously involved sites from nadir)."|up to 24 months|Intent to treat population||participants|||Number
158097|NCT00308087|Secondary|Summary of Treatment-Emergent Adverse Events (TEAE)|Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.|up to 12 weeks|Safety population||participants|||Number
158098|NCT00308087|Primary|Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12|Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.|Week 8 (confirmed at Week 12)|Intent to treat population||participants|||Number
158099|NCT00308074|Secondary|Brief Psychiatric Rating Scale for Children (BPRS-C)|"The Brief Psychiatric Rating Scale for Children is a 21-item rating scale to evaluate psychiatric problems based on the clinician’ s interview with the child/adolescent and parents. It has 7 scales: behavioral problems, depression, thought disorders, psychomotor excitation, withdrawal-retardation, anxiety, organicity. Ratings are based on a 7 point scale, from Not Present (scores 0) to Extremely Severe (scores 6 points). Total is the sum of the 21 items. The range of possible totals is 0 (no symptoms) to 126 (extremely severe).A decrease in score indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
158100|NCT00308074|Secondary|Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|10-item assessment of obsessive-compulsive symptoms in patients less than 18 years of age. There are 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale ( from 0=no symptoms/minimum severity, to 4=extreme symptoms/maximum severity). Total is the sum of 10 items. The range of possible totals is 0 (no symptoms) to 40 (severe). A decrease in value indicates improvement.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
158101|NCT00308074|Primary|Aberrant Behavior Checklist-Irritability Subscale|"Aberrant Behavior Checklist (ABC) The ABC is a 58 item symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. Items are rated on a 4-point scale (0=no problem to 3=severe problem). A decrease in score indicates improvement.~There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.This study uses the Irritability subscale for its outcome. The Irritability subscale is the sum of 15 items. Each item is rated using the scale: 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The Irritability subscale total score ranges from 0 to 45. A decrease in score over time indicates improvement."|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
158102|NCT00308074|Primary|Clinical Global Impressions-Improvement|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline, Endpoint using last observation carried forward (LOCF) at weeks 3,5,7,9,11 and 13.|||units on a scale||Standard Deviation|Mean
158103|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
158104|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
158105|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14|The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
158107|NCT00307931|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14|The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.|Baseline, and Weeks 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||Units on a scale||Standard Deviation|Mean
158108|NCT00307931|Secondary|C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14||Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||mg/L||Standard Deviation|Mean
158109|NCT00307931|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||score on a scale|||Number
158110|NCT00307931|Secondary|Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 2, 4, 6, 8, 12 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||score on a scale|||Number
158111|NCT00307931|Secondary|Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Weeks 1, 6 and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).||participants|||Number
158112|NCT00307931|Secondary|Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, 6 and 14|Due to the low number of subjects recruited only an abbreviated report was produced with limited analyses. This outcome measure was not included in the limited analyses.||participants|||Number
158113|NCT00307931|Secondary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline to Weeks 1, and 14 or Withdrawal|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).||participants|||Number
158114|NCT00307931|Primary|Number of Patients With at Least a 100-point Decrease From Baseline in Crohn’s Disease Activity Index (CDAI) Score at Week 6|The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline, Week 6|This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).||participants|||Number
158115|NCT00307801|Post-Hoc|Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||mL||Standard Deviation|Mean
158116|NCT00307801|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||Proportion of participants|||Number
158117|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 196|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
158118|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Not Have Any Medical Treatment） at Treatment Day 84|The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
158119|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 196|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
158120|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （no Out-of-pocket Expenses） at Treatment Day 84|The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
158121|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 196|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
158122|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Received Ambulatory Services） at Treatment Day 84|The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
158123|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 196|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
158124|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Additional Unscheduled Procedures） at Treatment Day 84|The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
158125|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
158126|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit to Physician） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
158127|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 196|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
158128|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Unscheduled Outpatient Visit at Hospital） at Treatment Day 84|The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
158129|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158130|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Regular Daily Activities） at Treatment Day 84|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158131|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 196.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158178|NCT00307489|Secondary|Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168|Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline.|168 weeks|Non-completer = Failure Analysis||Participants|||Number
158132|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Productivity While Working） at Treatment Day 84.|The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158133|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 196|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||days||Standard Deviation|Mean
158134|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Days Missed From Work） at Treatment Day 84|The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||days||Standard Deviation|Mean
158135|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 196.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 196|ITT, all participants with assessment at treatment day 196 for this outcome measure||Proportion of participants|||Number
158136|NCT00307801|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire （Change in the Employment Status） at Treatment Day 84.|The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed.|Treatment day 84|ITT, all participants with assessment at treatment day 84 for this outcome measure||Proportion of participants|||Number
158137|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158138|NCT00307801|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84.|"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale."|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158139|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 196|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158140|NCT00307801|Secondary|Change From Baseline in EuroQol 5 Dimensional (EQ-5D) Score at Treatment Day 84|The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158141|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158142|NCT00307801|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Score at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158143|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 196.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158179|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 168|Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline.|168 weeks|Non-completer = Failure Analysis||Percent of Participants|||Number
158144|NCT00307801|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Score at Treatment Day 84.|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||Scores on a scale||Standard Deviation|Mean
158145|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 196|Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196.|Baseline (visit 5, day 1) and treatment day 196|ITT, all participants with assessments at baseline and treatment day 196 for this outcome measure||ng/mL||Standard Deviation|Mean
158146|NCT00307801|Secondary|Change From Baseline in Ferritin Concentration at Treatment Day 84|Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84.|Baseline (visit 5, day 1) and treatment day 84|ITT, all participants with assessments at baseline and treatment day 84 for this outcome measure||ng/mL||Standard Deviation|Mean
158147|NCT00307801|Secondary|Change From Baseline in Hematocrit at Treatment Day 196.|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure||ng/mL||Standard Deviation|Mean
158148|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|Baseline (visit 5) and treatment day 196|ITT, all participants with assessments at baseline and day 196 for this outcome measure||g/dL||Standard Deviation|Mean
158149|NCT00307801|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|Baseline (visit 5) and treatment day 84|ITT, all participants with assessments at baseline and day 84 for this outcome measure||g/dL||Standard Deviation|Mean
158150|NCT00307801|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90 days before treatment (baseline) and those used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments for baseline and efficacy phase for this outcome measure||Sanitary protection products||Standard Deviation|Mean
158151|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|A bleeding day is a day on which sanitary protection is required. The number of bleeding days was determined for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure||Bleeding days||Standard Deviation|Mean
158152|NCT00307801|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode is characterized by the following: • Bleeding for at least 2 days • Bleeding days can be separated by no more than 1 bleeding-free day • An episode stops with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. negative value indicates a reduction from baseline in the number of episodes while under treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure||Bleeding episodes||Standard Deviation|Mean
158153|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.||ml||Standard Deviation|Mean
158154|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.||ml||Standard Deviation|Mean
158180|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 168|Subjects with elevated ALT at baseline that return to normal by Week 48.|168 weeks|||Percent of Participants|||Number
158181|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 168|ULN for males = 43 U/L; ULN for females = 34 U/L|168 weeks|Non-completers = failure analysis||Percent of Participants|||Number
158155|NCT00307801|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT consisted of all randomized subjects enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more, as assessed by the alkaline hematin method.||ml||Standard Deviation|Mean
158156|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment.|Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT consisted of all randomized subjects enrolled with excessive bleeding. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.||ml||Standard Deviation|Mean
158157|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 7 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure||ml||Standard Deviation|Mean
158158|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 3 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure||ml||Standard Deviation|Mean
158159|NCT00307801|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction.|Cycle 1 = 28 days (one cycle)|ITT, all participants with assessments for this outcome measure||ml||Standard Deviation|Mean
158160|NCT00307801|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss volume as assessed by the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|ITT, all participants with assessments at baseline and efficacy phase for this outcome measure||ml||Standard Deviation|Mean
158161|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient’s Overall Assessment Scale at Treatment Day 196|According to the patient´s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Patients assessed the overall improvement at day 196 compared with admission to the study condition.|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure||Proportion of participants|||Number
158162|NCT00307801|Secondary|Proportion of Participants With Improvement in the Patient’s Overall Assessment Scale at Treatment Day 84|According to the patient’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Patients assessed the overall improvement at day 84 compared with admission to the study condition.|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure||Proportion of participants|||Number
158163|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 196|According to the investigator’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 196 compared with admission to study data.|From baseline (visit 5, day 1) up to treatment day 196|ITT, all participants with assessment at day 196 for this outcome measure||Proportion of participants|||Number
158164|NCT00307801|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 84|According to the investigator’s global assessment scale “improved” was defined as being classified as ‘very much improved’, ‘much improved’, or ‘improved’ and “not improved” was defined as being classified as ‘no change’, ‘worse’, ‘much worse’, ‘very much worse’, or ‘not assessed’. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 84 compared with admission to study data.|From baseline (visit 5, day 1) up to treatment day 84|ITT, all participants with assessment at day 84 for this outcome measure||Proportion of participants|||Number
158165|NCT00307801|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall. Cure from frequent bleeding: no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and no increase from baseline in an individual patient’s total number of bleeding days occurred|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with frequent bleeding: greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall|||||
158166|NCT00307801|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding:>=2 bleeding episodes each with blood loss volume (MBL) of >=80 mL in 90-day period, assessed by alkaline hematin method. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. Cure from excessive bleeding: MBL in each episode <80 mL + blood loss volume associated with each bleeding episode is decrease of ≥50% from average of qualifying bleeding episodes (with blood loss volume ≥80 mL per episode during run-in)|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects who enrolled with excessive bleeding: 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day run-in period, as assessed by the alkaline hematin method||Proportion of participants|||Number
158167|NCT00307801|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days. Cure from prolonged bleeding: no bleeding episodes lasting more than 7 days and the decrease between maximum duration during run-in and maximum duration during the efficacy phase was at least 2 days.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|The ITT population consisted of all randomized subjects with prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days||Proportion of participants|||Number
158168|NCT00307801|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) >7 days, no >4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no >1 BE increase from baseline, no increase from baseline in individual patient’s total number of bleeding days and total number of bleeding days not >24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in.|Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7|Intent-To-Treat (ITT): all randomized subjects with ≥1 of the DUB symptoms in 90-day run-in phase: Prolonged bleeding: ≥2 bleeding episodes, each lasting ≥8 days Frequent bleeding: >5 bleeding episodes, with minimum of 20 bleeding days overall. Excessive bleeding: ≥2 bleeding episodes each with blood loss volume (=MBL) of ≥80 mL||Proportion of participants|||Number
158169|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score|Evaluation of treatment effects as rated by the subjects on the CAARS-S:S. best score: 0 worst score: 104|DB baseline, DB endpoint|||units on a scale||Standard Deviation|Mean
158170|NCT00307684|Secondary|Change From DB Baseline to DB Endpoint in CGI-S Score|evaluation of treatment effects as rated by the investigator on the CGI-S scale. CGI-S is used to rate the severity of a subject’s illness on a 7- point scale ranging from 1 (not ill) to 7 (extremely severe).|DB baseline, DB endpoint|Intent to treat: all subjects who used study medication at least once||units on a scale||Standard Deviation|Mean
158171|NCT00307684|Secondary|Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint|Quality of life measured by Q-LES-Q best score: 100 worst score: 0|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
158172|NCT00307684|Secondary|Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint|Assessment of the long term effect on overall functioning measured by CGI-S best score: 1 worst score: 7|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
158173|NCT00307684|Primary|Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint|"To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS.~CAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54~Endpoint: last available post-baseline assessment."|DB baseline, DB endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
158174|NCT00307684|Secondary|Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores|"Long term efficacy of PR OROS MPH as assessed by investigator-rated CAARS total score, hyperactivity/impulsivity subscale score and inattention subscale score.~Subscale scores: best value: 0, worst value: 27"|OL baseline, OL endpoint|intent to treat: all subjects who used trial medication at least once||units on a scale||Standard Deviation|Mean
158175|NCT00307684|Primary|Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)|To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)|Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks|intent-to-treat: all subjects who used the study medication at least once||participants|||Number
158176|NCT00307489|Secondary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168|P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|168 weeks|Non-completers = failure analysis||Percent of Participants|||Number
158177|NCT00307489|Secondary|HBsAg Loss at Week 168|Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline.|168 weeks|||Participants|||Number
158187|NCT00307489|Secondary|HBeAg Seroconversion at Week 48|Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive Baseline HBeAg. Non-Completers=Failure||participants|||Number
158188|NCT00307489|Secondary|Hepatitis B Early Antigen (HBeAg) Loss at Week 48|Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline.|48 Weeks|RAT Analysis Set with Positive HBeAg at Baseline. Non-Completers=Failure||participants|||Number
158189|NCT00307489|Secondary|Percentage of Participants With Normalized ALT at Week 48|Subjects with elevated ALT at baseline that return to normal by Week 48.|48 Weeks|RAT Analysis Set - subjects with ALT above ULN at baseline. Non-Completers=Failure||percentage of participants|||Number
158190|NCT00307489|Secondary|Percentage of Participants With Normal ALT at Week 48|ULN for males = 43 U/L; 34 U/L for females|48 Weeks|RAT Analysis Set Non-Completers=Failure||percentage of participants|||Number
158191|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48||48 Weeks|RAT Analysis Set Non-Completers=Failure||percentage of participants|||Number
158192|NCT00307489|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48||48 Weeks|RAT Analysis Set||U/mL||Standard Deviation|Mean
158193|NCT00307489|Secondary|Change From Baseline in log10 Plasma HBV DNA Levels at Week 48||48 Weeks|RAT Analysis Set||log10 copies/mL||Standard Deviation|Mean
158194|NCT00307489|Primary|Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48||48 weeks|Randomized and Treated (RAT) subjects at Week 48 - Non-Completers=Failure (ie, includes subjects who switched to open-label FTC/TDF at or after Week 24)||percentage of participants|||Number
158195|NCT00307437|Secondary|Number of Participants Visits With Psoriasis Area and Severity Index (PASI) 75 From Week 40 Through Week 52|Number of visits at which participants randomized at Week 28 achieved at least 75 percent improvement from baseline in PASI from Week 40 through Week 52 in participants randomized at Week 28. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 40 to Week 52|All participants randomized at Week 28 were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.||Participants||Inter-Quartile Range|Median
158196|NCT00307437|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the partcipant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Units on a scale||Inter-Quartile Range|Median
158197|NCT00307437|Secondary|Number of Participants With Physician Global Assessment (PGA) of Cleared or Minimal at Week 12|Number of participants achieving a physician global assessment (PGA) (0 [none] to 5 [severe]) of cleared or minimal at Week 12. The PGA is 7-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe).|Week 12|Intent to treat. All participants were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.||Participants|||Number
158198|NCT00307437|Primary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent or Above at Week 12|Number of participants achieving greater than or equal to 75 percent improvement in PASI at Week 12. PASI is a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a person's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or had missing data at Week 12.||Participants|||Number
158199|NCT00307333|Secondary|Mortality||120 days|||participants|||Number
158200|NCT00307333|Secondary|Days on Antibiotics||120 days|||days||Standard Deviation|Mean
158201|NCT00307333|Secondary|Duration of Hospital Stay||120 days|||days||Standard Deviation|Mean
158202|NCT00307333|Primary|Number of Ventilator-free Days||120 days|||days||Standard Deviation|Mean
158203|NCT00307294|Secondary|Tolerance/Safety||4 weeks||||||
158204|NCT00307294|Secondary|Overall Survival||36 months||||||
158205|NCT00307294|Secondary|Clinical Response Rate||4 weeks||||||
158206|NCT00307294|Primary|Response Rate||24 weeks|||percentage of participants||95% Confidence Interval|Number
158207|NCT00307164|Secondary|Change in Creatine Kinase From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 creatine kinase data was missing and post-baseline creatine kinase was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||IU/L||Inter-Quartile Range|Median
158208|NCT00307164|Secondary|Change in Leukocytes From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 leukocyte data was missing and post-baseline leukocyte was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||cells*10^3/L||Inter-Quartile Range|Median
158209|NCT00307164|Secondary|Change in Hemoglobin From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 hemoglobin data was missing and post-baseline hemoglobin was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||g/dL||Inter-Quartile Range|Median
158210|NCT00307164|Secondary|Change in Fasting Triglycerides From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting triglyceride data was missing and post-baseline fasting triglyceride was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
158211|NCT00307164|Secondary|Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting LDL data was missing and post-baseline fasting LDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
158212|NCT00307164|Secondary|Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting non-HDL data was missing and post-baseline fasting non-HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF or due to associated triglyceride was >400 mg/dL. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
158213|NCT00307164|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting HDL data was missing and post-baseline fasting HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
158214|NCT00307164|Secondary|Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting total cholesterol was missing and post-baseline fasting total cholesterol was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
158215|NCT00307164|Secondary|Change in Fasting Glucose From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting glucose was missing and post-baseline fasting glucose was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mg/dL||Inter-Quartile Range|Median
158216|NCT00307164|Secondary|Change in Fasting Lactate From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 fasting lactate was missing and post-baseline fasting lactate was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||mmol/L||Inter-Quartile Range|Median
158217|NCT00307164|Secondary|Change in CD4+ Count From Baseline (Week 48 - Baseline)||Baseline and Week 48|Intention to treat analysis with LOCF if week 48 CD4+ data was missing and post-baseline data was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||cells/mm3||Inter-Quartile Range|Median
158218|NCT00307164|Secondary|HIV-1 RNA Level||At Week 48|Intention to treat analysis with all randomized subjects. Reduced sample size was due to missing data at week 48.||Participants|||Number
158219|NCT00307164|Secondary|Change in Limb Fat From Baseline (Week 24 - Baseline)|Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups.|Baseline and Week 24|Intention to treat analysis with LOCF if week 24 limb fat data was missing and post-baseline before week 24 limb fat observation was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||grams||Inter-Quartile Range|Median
158220|NCT00307164|Secondary|Number of Subjects Discontinuing Study Medication|Number of eligible subjects who discontinued study medication during the study period.|Through Week 48|Intention to treat analysis based on all subjects who started study treatment.||Participants|||Number
158221|NCT00307164|Secondary|Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)|Time to safety events (grade 3 [Severe] or 4 [life-threatening] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry|Through Week 48|As-treated analysis with subjects stratified based on ART (d4T or AZT).||weeks||Inter-Quartile Range|Median
158222|NCT00307164|Primary|Change in Limb Fat (g) From Baseline|Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.|Baseline and Week 48|Intention to treat analysis with last observation carried forward (LOCF) if week 48 limb fat data was missing and post-baseline limb fat was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT).||grams||Inter-Quartile Range|Median
158223|NCT00307151|Secondary|Time From Randomization to Death|Results report 2nd percentile of time from randomization to death|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
158224|NCT00307151|Secondary|Time From Randomization to HIV-related Disease Progression or Death|HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
158225|NCT00307151|Secondary|Change in CD4 Percent From Entry to Week 48|Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.|48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort||Percent of CD4||95% Confidence Interval|Mean
158492|NCT00305162|Secondary|Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI|(a patient could have multiple procedural events)|during index PCI|mITT (excluding STEMI) and based on available data||participants|||Number
158226|NCT00307151|Secondary|Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus|Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure.||participants|||Number
158227|NCT00307151|Secondary|Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment|Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.|On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first||Weeks||95% Confidence Interval|Number
158228|NCT00307151|Secondary|Time From Randomization to Virologic Failure|Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
158229|NCT00307151|Secondary|Percent of Participants Experiencing Virologic Failure|Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population.||Percent of participants|||Number
158230|NCT00307151|Secondary|Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR a confirmed viral rebound >4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.|Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)|Analysis uses intent to treat population||Weeks||95% Confidence Interval|Number
158231|NCT00307151|Primary|Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment|Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is <1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level >400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.|Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)|Analysis uses intent to treat population||Percent of participants|||Number
158232|NCT00307125|Secondary|Number of Participants With Viral Replication of Polyomavirus (BKV)|Number of participants with viral replication of BKV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of a BKV infection. Polyomavirus BK is a significant pathogen in transplant recipients.|1 year post treatment initiation|Intent-to-treat||participants|||Number
158233|NCT00307125|Secondary|Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV)|Number of participants with positive viral replication of EBV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of EBV viral replication is indicative of active infection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
158234|NCT00307125|Secondary|Number of Participants With Viral Replication of Cytomegalovirus (CMV)|Number of participants with viral replication of CMV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of active CMV infection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
158235|NCT00307125|Secondary|Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy|Number of participants with loss of PTC C4d staining on kidney (renal) biopsy within 12 months post treatment initiation. PTC C4d staining on biopsy indicates organ rejection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
158236|NCT00307125|Secondary|Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD)|Number of participants with PTLD within 12 month post treatment initiation. Diagnosis of PTLD was made by B cell proliferation after therapeutic immunosuppression.|1 year post treatment initiation|Intent-to-treat||participants|||Number
158237|NCT00307125|Secondary|Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation|Number of participants with graft loss, defined as the need for dialysis for greater than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure within 12 month post treatment initiation|1 year post treatment initiation|Intent-to-treat||participants|||Number
158238|NCT00307125|Secondary|Number of Deaths 12 Months Post Treatment Initiation|Number of participant deaths within 12 months post treatment initiation|12 months post treatment initiation|Intent-to-treat||participants|||Number
158513|NCT00304031|Secondary|Correlation of Tumor MGMT Gene Methylation Status With Treatment Response||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
158239|NCT00307125|Primary|Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies|Number of participants with 50% decrease in circulating anti-HLA antibodies at any time within the first 12 months post kidney transplant by LuminexTM Beads Method. Luminex assays for quantitation and detection of cytokine and signal transduction proteins. Presence of circulating antibodies is indicative of the transplant recipient’s immune system responding to the transplanted organ as a foreign object or infection.|1 year post treatment initiation|Intent-to-treat||participants|||Number
158240|NCT00307125|Primary|During Screening Phase: Timing of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. Of these, 79 (12%) developed de novo HLA-antibodies (anti-HLA Ab). This outcome looks at the average length of time (interval) from post kidney transplant until development of alloantibody. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection|During screening window of 3-60 months post kidney transplant|Screening sample||Months||Standard Deviation|Mean
158241|NCT00307125|Primary|During Screening Phase: Incidence of Alloantibody Development|Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection.|During screening window of 3-60 months post kidney transplant|Screening sample||participants|||Number
158242|NCT00307086|Primary|Median Number of Months Overall Survival (OS)After First Peripheral Blood Stem Cell Transplant (PBSCT)||2 years post transplant|median overall survival from the time of first transplant||months||95% Confidence Interval|Median
158243|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|3 years|||Percentage of participants|||Number
158244|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|2 years|||Percentage of participants|||Number
158245|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|270 days|||Percentage of participants|||Number
158246|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|180 days|||Percentage of participants|||Number
158247|NCT00307047|Secondary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|30 days|||Percentage of participants|||Number
158248|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||3 years|||Percentage of participants|||Number
158249|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||2 years|||Percentage of participants|||Number
158250|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||1 year|||Percentage of participants|||Number
158251|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||270 days|||Percentage of participants|||Number
158252|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||180 days|||Percentage of participants|||Number
158253|NCT00307047|Secondary|Cardiac Death or Target Vessel MI Rate||30 days|||Percentage of participants|||Number
158254|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-1123 days|||Percentage of participants|||Number
158255|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-758 days|||Percentage of participants|||Number
158256|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-393 days|||Percentage of participants|||Number
158257|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|31-393 days|||Percentage of participants|||Number
158514|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Methylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
158258|NCT00307047|Secondary|Protocol Defined Stent Thrombosis Rate|"ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of ST~In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis."|0-30 days|||Percentage of participants|||Number
158259|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-1123 days|||Percentage of participants|||Number
158260|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including primary as well as secondary late ST; secondary late ST is after a target segment revascularization."|0-758 days|||Percentage of participants|||Number
158261|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|0 -393 days|||Percentage of participants|||Number
158262|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on ARC Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|31-393 days|||Percentage of participants|||Number
158263|NCT00307047|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|"ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post~* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.~† Including “primary” as well as “secondary” late ST; “secondary” late ST is after a target segment revascularization."|0-30 days|||Percentage of participants|||Number
158264|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||3 years|||Percentage of participants|||Number
158265|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||2 years|||Percentage of participants|||Number
158266|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||1 year|||Percentage of participants|||Number
158267|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||270 days|||Percentage of participants|||Number
158268|NCT00307047|Primary|Ischemia Driven Target Lesion Failure (TLF)|Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).|1 year|||Percentage of participants|||Number
158269|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||180 days|||Percentage of participants|||Number
158270|NCT00307047|Secondary|Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)||30 days|||Percentage of participants|||Number
158271|NCT00307047|Secondary|All Cause Mortality||3 years|||Percentage of participants|||Number
158272|NCT00307047|Secondary|All Cause Mortality||2 years|||Percentage of participants|||Number
158273|NCT00307047|Secondary|All Cause Mortality||1 year|||Percentage of participants|||Number
158274|NCT00307047|Secondary|All Cause Mortality||270 days|||Percentage of participants|||Number
158275|NCT00307047|Secondary|All Cause Mortality||180 days|||Percentage of participants|||Number
158276|NCT00307047|Secondary|All Cause Mortality||30 days|||Percentage of participants|||Number
158277|NCT00307047|Secondary|All MI||3 years|||Percentage of participants|||Number
158278|NCT00307047|Secondary|All MI||2 years|||Percentage of participants|||Number
158279|NCT00307047|Secondary|All MI||1 year|||Percentage of participants|||Number
158280|NCT00307047|Secondary|All MI||270 days|||Percentage of participants|||Number
158281|NCT00307047|Secondary|All MI||180 days|||Percentage of participants|||Number
158282|NCT00307047|Secondary|All Myocardial Infarction (MI)||30 days|||Percentage of participants|||Number
158300|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days|ITT population||percentage of participants|||Number
158283|NCT00307047|Secondary|Acute Success (Clinical Procedure)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.|Acute: At time of index procedure|Clinical procedure success is computed per subject||Percentage of success|||Number
158284|NCT00307047|Secondary|Acute Success (Clinical Device)|Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.|Acute: At time of index procedure|clinical device success is computed per lesion||Percent of success|||Number
158285|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|3 years|||Percentage of participants|||Number
158286|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|2 years|||Percentage of participants|||Number
158287|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|1 years|||Percentage of participants|||Number
158288|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|270 days|||Percentage of participants|||Number
158289|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|180 days|||Percentage of participants|||Number
158290|NCT00307047|Secondary|Ischemia Driven Major Adverse Cardiac Events (MACE)|Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR|30 days|||Percentage of participants|||Number
158291|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years|||percentage of participants|||Number
158292|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years|||percentage of participants|||Number
158293|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year|||percentage of participants|||Number
158294|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|270 days|||percentage of participants|||Number
158295|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days|||percentage of participants|||Number
158296|NCT00307047|Secondary|Ischemia Driven Target Vessel Revascularization (TVR)|"Revascularization of a lesion within the target vessel associated with any of the following:~positive functional ischemia study~ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days|||percentage of participants|||Number
158297|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|3 years|ITT population.||percentage of participants|||Number
158298|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|2 years|ITT population.||percentage of participants|||Number
158299|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|1 year|ITT population.||percentage of participants|||Number
158301|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|180 days|ITT population||percentage of participants|||Number
158302|NCT00307047|Secondary|Ischemia Driven Target Lesion Revascularization (TLR)|"Revascularization of a target lesion associated with any of the following:~positive functional ischemia study~ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)~angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study"|30 days|ITT population.||percentage of participants|||Number
158303|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|3 years|ITT, @ 3 years||percentage of participants|||Number
158304|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|2 years|ITT, @ 2 years||percentage of participants|||Number
158305|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|1 year|ITT, @ 1 yr||percentage of participants|||Number
158306|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|270 days|||percentage of participants|||Number
158307|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|180 days|||percentage of participants|||Number
158308|NCT00307047|Secondary|Ischemia Driven Target Vessel Failure (TVF)|Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR|30 days|||percentage of participants|||Number
158309|NCT00306917|Primary|Harris Hip Score (HHS)|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.|Preoperative, 6, 12, 24, 36, 48, and 60 months|Before the first interval there were five missing HHS scores for the DuoFix arm and four missing HHS scores for the Porocoat Porous Coated arm. At the final interval (60 months), there were eleven subjects in the DuoFix arm with complete HHS scores and there were fourteen subjects in the Porocoat Porous Coated arm with complete HHS scores.||Units on a scale||Standard Deviation|Mean
158310|NCT00306917|Secondary|Medical Imaging||postoperative, 6, 12, 24, 36, 48 and 60 months||||||
158311|NCT00306891|Secondary|Part B: Progression-free Survival (PFS)|"Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).~Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.~Progression (PD) Unequivocal progression of existing non-target lesions."|Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.|ITT (intention-to-treat ) patients with baseline RECIST data.One patient was randomized and had baseline RECIST assessments, but did not have any further RECIST assessments. Therefore they were censored at baseline, meaning the lowest value in the range was set to zero.||Days||Full Range|Median
158312|NCT00306891|Secondary|Part B: Best Overall Response Rate (ORR)|"Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions.~Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions"|Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.|ITT (intention-to-treat ) patients with baseline RECIST data||Participants|||Number
158313|NCT00306891|Secondary|Part A: Apparent Total Body Clearance (CL/F)|Apparent total body clearance of drug from plasma|Measurements were collected up to 168 hours (following single dosing).|||L/h||Full Range|Geometric Mean
158314|NCT00306891|Secondary|Part A: Terminal Phase Half-life (t1/2λz)|Terminal phase half-life|Measurements were collected up to 168 hours (following single dosing).|||hr||Full Range|Geometric Mean
158315|NCT00306891|Secondary|Part A: Time to Peak or Maximum Concentration (Tmax)|Time to reach peak or maximum concentration or maximum response|Measurements were collected up to 168 hours (following single dosing).|||hr||Full Range|Geometric Mean
158316|NCT00306891|Secondary|Part A: AUC (0-t)|Area under the curve from time 0 to the last measureable time point|Measurements were collected up to 168 hours (following single dosing).|||ng*h/mL||Full Range|Geometric Mean
158317|NCT00306891|Primary|Part A: Maximum Plasma (Peak) Concentration (Cmax)|Maximum plasma drug concentration|Measurements were collected up to 168 hours (following single dosing).|||ng/mL||Full Range|Geometric Mean
158318|NCT00306891|Primary|Part A: Area Under Plasma Concentration-time Curve (AUC)|Area under plasma concentration-time curve from zero to infinity|Measurements were collected up to 168 hours (following single dosing).|||ng*h/mL||Full Range|Geometric Mean
158515|NCT00304031|Secondary|Comparison of OS and PFS in Patients With Unmethylated MGMT||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
158319|NCT00306852|Secondary|Failure Rate|Failure was prospectively defined as IOP greater than 21 mm Hg or less than 20 percent reduction below baseline on 2 consecutive follow-up visits after 3 months, IOP less than or equal to 5 mm Hg on 2 consecutive follow-up visits after 3 months, re-operation for glaucoma, or loss of light perception vision.|5 years|||percentage of participants|||Number
158320|NCT00306852|Secondary|Need for Supplemental Medical Therapy|The number of supplemental glaucoma medications required in the Implant Group and Trabeculectomy Group at 5 years|5 years|||number of medications||Standard Deviation|Mean
158321|NCT00306852|Secondary|Reoperations for Glaucoma|Reoperations for glaucoma was defined as additional glaucoma surgery requiring a return to the operating room.|5 years|||participants|||Number
158322|NCT00306852|Secondary|Visual Acuity|Visual acuity was measured by the total number of letters read (correctly) using a ETDRS eye chart|5 years|Participants who complete 5 years of follow-up||Letters||Standard Deviation|Mean
158323|NCT00306852|Primary|Rate of Complications|Complications associated with both surgical procedures|5 years|||participants|||Number
158324|NCT00306852|Primary|Change in Intraocular Pressure|The data value from the Baseline visit and 5 year follow-up visit were combined. Specifically, values were calculated by subtracting the 5 Year Intraocular Pressure from the Baseline Intraocular Pressure.|Baseline to 5 years|Participants who completed 5 years of follow-up||mm Hg||Standard Deviation|Mean
158325|NCT00306787|Secondary|Time to a Second Recurrence of Genital Herpes|"Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:~From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or~From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence."|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population. Patients with missing time-to-second recurrence were not included in the calculation of the median.||days||Inter-Quartile Range|Median
158326|NCT00306787|Secondary|Number of Patients With a Second Recurrence of Genital Herpes|Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence.|Up to 6 months after investigator assessed healing of first recurrence of genital herpes|ITT population included all randomized patients who initiated treatment with (i.e. received any dose of) the study drug, with the intention of treating genital herpes recurrences.||participants|||Number
158327|NCT00306787|Secondary|Time to Resolution of Symptoms Associated With Recurrent Genital Herpes|Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms.|72 hours after initiation of study medication up to Day 20|ITT population. If the resolution of any or all symptoms was not confirmed by a subsequent visit or diary entry, the time to resolution was censored at the time of the last diary entry. If a patient dropped out before any diary entries were created, the patient was assigned a censoring time of 0. n= number of patients with symptoms.||hours||Inter-Quartile Range|Median
158328|NCT00306787|Secondary|Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method.|72 hours after initiation of study medication up to Day 20|ITT population. Median time was estimated by kaplan-Meier method by censoring the missing non-aborted times at last clinical observation. Patients with aborted lesions were assigned a time to healing of zero.||days||Inter-Quartile Range|Median
158329|NCT00306787|Secondary|Percentage of Participants With Aborted Genital Herpes Lesions|Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions.|72 hours after initiation of study medication up to Day 20|ITT population. Patients who discontinued from the study before healing of non-aborted lesions was confirmed and patients who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were assumed to have non-aborted lesions in this analysis.||Percentage of participants|||Number
158330|NCT00306787|Primary|Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions|Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.|72 hours after initiation of study medication up to Day 20|Modified Intent To Treat (mITT) population. The mITT population included all patients who initiated treatment with the study drug, with the intention of treating genital herpes recurrences who developed non-aborted genital herpes lesions during the treated recurrence except those with confirmed aborted lesions at the final clinical assessment.||days||Inter-Quartile Range|Median
158331|NCT00306670|Primary|To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.|the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated|When 25 patients have completed the study.|2 patients with acquired hemophilia A: two patients were recruited, but the sponsor terminated the study before the patients started treatment||Participants|||Count of Participants
158357|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at Baseline|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.||participants|||Number
158332|NCT00306592|Primary|Number of Participants With Antibodies to Natalizumab|‘Positive with unknown persistence’ is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. ‘Transient positive’ is defined as a positive at one timepoint but negative upon re-test at least 42 days later. ‘Persistent positive’ is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.|Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)|All participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody result after the first dose.||participants|||Number
158333|NCT00306592|Primary|Number of Participants With Hypersensitivity-related Adverse Events|For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.|Baseline through Week 48|Participants receiving at least 1 dose of study drug||participants|||Number
158334|NCT00306592|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)|AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.|Baseline through Week 48|Participants receiving at least 1 dose of study drug||participants|||Number
158335|NCT00306527|Primary|Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine|To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .|Day 1 to Day 7 postvaccination|This analysis was done on safety dataset||Participants|||Number
158336|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine.~Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer."|Day 22 postvaccination|This analysis was done on the immunogenicity subset.||Percentages of subjects||95% Confidence Interval|Number
158337|NCT00306527|Secondary|Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.|"Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine.~European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is > 70% for adults and >60% for elderly."|Day 22 postvaccination|This analysis was done on immunogenicity subset.||Percentages of subjects||95% Confidence Interval|Number
158338|NCT00306527|Secondary|Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria.~The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5 for adults and >2.0 for elderly subjects."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.||Ratio||95% Confidence Interval|Geometric Mean
158339|NCT00306527|Secondary|Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects|"The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs.~The HI GMTs were evaluated using egg-derived antigen assay."|Day 22 postvaccination|The analysis was done on the immunogenicity subset.||Titers||95% Confidence Interval|Geometric Mean
158340|NCT00306527|Secondary|Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine|To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician’s visit and/or resulting in premature subject’s withdrawal from study.|Upto 6 months postvaccination|This analysis was done on the safety dataset.||Participants|||Number
158341|NCT00306488|Secondary|The Change in Total Drusen Area From Baseline to Year 2.||2 years||||||
158342|NCT00306488|Secondary|The Change in the Number of Scotomatous Points Between Study and Fellow Eyes From Baseline to Year 2.|Scotomatous points are testing points on microperimetry examination that are centered on the macula and report a lack of retinal sensitivity within the range tested.|2 years||||||
158358|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 Ph+ ALL or AP/BP-CML|BCR-ABL = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
158516|NCT00304031|Secondary|Progression-free Survival (PFS)||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
158343|NCT00306488|Secondary|The Change in Contrast Sensitivity as Measured by the Pelli-Robson Chart From Baseline to Year 2.|The Pelli-Robson Chart is comprised of 10 groups of 3 large letters with levels of contrast ranging from 100% (black against white) to 1% (very light gray against white). Each eye is assigned a score based on the contrast of the last group in which two or three letters were correctly read. A score of 2 log units, which represents a normal sensitivity contrast, indicates that the eye was able to detect two of the three letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2).|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."||Log Units|Participants|Standard Deviation|Mean
158344|NCT00306488|Secondary|The Change in GA, as Measured on Stereoscopic Color Fundus Photography (CFP) From Baseline to Year 2.|GA was also measured using Stereoscopic Color Fundus Photography (CFP), which produces color images of the inside of the eye.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."||mm^2|Participants|Standard Deviation|Mean
158345|NCT00306488|Secondary|The Change in Geographic Atrophy (GA), as Measured on Fundus Autofluorescence Imaging Using a Confocal Scanning Ophthalmoscope (HRA FAF) From Baseline to Year 2.|Geographic Atrophy (GA), or the death of photoreceptors and surrounding cells in the retina, is a common condition in patients with Age-Related Macular Degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The amount of GA is measured from images produced via a non-invasive technique called Fundus Autofluorescence Imaging, which uses a Confocal Scanning Ophthalmoscope to detect the naturally-fluorescing lipofuscin (the waste that is left behind by dead photoreceptors and digested by surrounding cells) that is prevalent at the border of the lesion.|2 years|"Data collected from the ten participants that completed the full twenty-four months of the study were analyzed.~Ten study eyes and ten fellow eyes were analyzed."||mm^2|Participants|Standard Deviation|Mean
158346|NCT00306488|Primary|The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|2 years|"Data collected from the 10 participants that completed the 24-month follow-up visit were analyzed.~Ten study eyes and 10 fellow eyes were analyzed."||ETDRS Letters|Participants|Standard Deviation|Mean
158347|NCT00306384|Secondary|Percentage of Participants With a Clinical Response|"Clinical response was defined based on the absolute value of HbA1c meeting one of two clinical targets at any post-baseline visit:~HbA1c ≤6.5%;~HbA1c ≤7.0%."|Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.|Safety set.||percentage of participants|||Number
158348|NCT00306384|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight to the last post-baseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set for whom data was available.||kg||Standard Deviation|Mean
158349|NCT00306384|Secondary|Change From Baseline in C-peptide Level|C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002 are not included.||ng/mL||Standard Deviation|Mean
158350|NCT00306384|Secondary|Change From Baseline in Insulin Level|The change from Baseline in fasting insulin at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data was available. Does not include patients enrolled in Protocol 01-05-TL-OPI322-001 or Protocol 01-06-TL-OPI322-002.||μIU/mL||Standard Deviation|Mean
158351|NCT00306384|Secondary|Change From Baseline in Proinsulin Level|"Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.~Note: A transcription error occurred in the reporting of 1 proinsulin value for a patient in the alogliptin 25 mg completed group, for whom a partial patient ID number was mistakenly entered as an end-of-treatment proinsulin level."|Baseline and Year 4|Safety set where data were available.||pmol/L||Standard Deviation|Mean
158352|NCT00306384|Secondary|Percentage of Participants With Marked Hyperglycemia|"Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (≥11.10 mmol/L).~The Month 42 to Month 45 interval includes all marked hyperglycemic episodes occurring on or after Day 1247 (a 203-day visit window)."|Randomization up to 4 years.|Safety set where data were available.||percentage of participants|||Number
158353|NCT00306384|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in fasting plasma glucose (FPG) at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug.|Baseline and Year 4|Safety set where data were available.||mg/dL||Standard Deviation|Mean
158354|NCT00306384|Secondary|Change From Baseline Over Time in Glycosylated Hemoglobin|The change from Baseline in glycosylated hemoglobin (HbA1c; the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Endpoint was defined as the last postbaseline observation collected within 7 days after the last dose of open-label study drug.|Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.|Safety set where data were available.||percent glycosylated hemoglobin||Standard Deviation|Mean
158355|NCT00306384|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.|4 years|Safety set||percentage of participants|||Number
158356|NCT00306202|Secondary|Number of Participants With FLT3 and KIT Mutations in Stratum4 Ph- ALL/AML at End-Of-Treatment|FLT3 and KIT = These are fused genes found in participants with this type of leukemia.|At EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.||participants|||Number
158534|NCT00303901|Secondary|Correlate Procedural Parameters and Follow-up Imaging Parameters||at 3, 6, and 12 months||||||
158359|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) at Baseline by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN–8.0 mg/dL, GR2=<8.0–7.0 mg/dL, GR3=<7.0–6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN–1.2 mg/dL, GR2=<1.2–0.9 mg/dL, GR3=<0.9–0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN – 2.5 mg/dL, GR2=<2.5 – 2.0 mg/dL, GR3=<2.0 – 1.0 mg/dL, GR4=<1.0 mg/dL.|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
158360|NCT00306202|Other Pre-specified|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.~ULN=upper limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
158361|NCT00306202|Other Pre-specified|Number of Participants With Hematologic Toxicity at Baseline by NCI CTCAE Version 3.0|"GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. White Blood Cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC): GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.~LLN=lower limit of normal."|At baseline (within 1 week before initiation of study therapy)|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
158362|NCT00306202|Secondary|Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML|BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.|At baseline (within 3 weeks before initiation of study therapy)|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
158363|NCT00306202|Secondary|Concentration of Dasatinib in Cerebrospinal Fluid (CSF) by Dose Level and Age Group|"Concentration of dasatinib in CSF was assessed only in participants who had lumbar puncture during the treatment.~y=years"|4 hours after oral dose|"All treated participants with CSF samples available. n=number of PK parameters included.~Each participant could have more than 1 CSF profiles sampled, depending on the number of times the dose of dasatinib was escalated."||ng/mL||Standard Deviation|Mean
158364|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
158365|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||hour||Full Range|Median
158366|NCT00306202|Secondary|Dasatinib Metabolite (BMS-582691) Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|All treated participants with plasma samples available. n=number of PK parameters included. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.||ng/mL||Geometric Coefficient of Variation|Geometric Mean
158367|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||hour||Standard Deviation|Mean
158368|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(INF) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. n=number of PK parameters included.~Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
158535|NCT00303901|Secondary|Rate of Complications and Adverse Reactions by Occurrences of Toxicities||at 3, 6, and 12 months||||||
158369|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-T) is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
158370|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) By Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have more than 1 plasma profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||hour||Full Range|Median
158371|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Observed Maximum Plasma Concentration (Cmax) by Dose Level and Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||ng/mL||Geometric Coefficient of Variation|Geometric Mean
158372|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
158373|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-T]) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-T] is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, normalized by dasatinib dose level.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||ng.h/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
158374|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Dose Normalized Observed Maximum Plasma Concentration (Cmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Dose Normalized Cmax is the maximum observed concentration of drug substance in plasma normalized for different dasatinib dose levels.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||ng/mL/mg/m^2||Geometric Coefficient of Variation|Geometric Mean
158375|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic Parameter: Terminal Half-life (T 1/2) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||hours||Geometric Coefficient of Variation|Geometric Mean
158376|NCT00306202|Secondary|Dasatinib Plasma Pharmacokinetic (PK) Parameter: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) by Age Group|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|During Week 1 of Course 1, and any course in which dose escalation was performed (at pre-dose, and at 0.5, 1, 2, 4, 6, 8 and 24 hours).|"All treated participants with plasma samples available. Each participant could have 1, 2, or 3 plasma PK profiles sampled, depending on the number of times the dose of dasatinib was escalated.~n=number of PK parameters included."||hours||Full Range|Median
158377|NCT00306202|Secondary|Overall Survival (OS)|Defined as time in months from start of study therapy to death. The OS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median OS time was computed using the Brookmeyer and Crowley method.|From start of study therapy until death or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy. Participants lost to followup were censored on the last date the participant was known to be alive.||months||95% Confidence Interval|Median
158416|NCT00305864|Primary|Median Overall Survival (Phase II)|Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially forllowed for at least 18 months.|All eligible patients.||Months||95% Confidence Interval|Median
158378|NCT00306202|Secondary|Progression Free Survival (PFS)|"Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator.~Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment.~The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley."|From the date of randomization to date of progression, death, last tumor assessment, or 5 years after EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|"All treated participants: Participants who received at least 1 dose of study therapy.~If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported."||months||95% Confidence Interval|Median
158379|NCT00306202|Secondary|Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay.~MMR: Ratio of the BCR-ABL to ABL <10^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL <10^-3 on the international scale in participants with p210 variant.~BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
158380|NCT00306202|Secondary|Number of Participants With Molecular Responses in Stratum 1 (Ph+ CP-CML)|"Molecular response was calculated by measuring p210 variant of BCR-ABL transcripts in blood during treatment using quantitative polymerase chain reaction (qPCR) assay.~Major molecular response (MMR): Ratio of the BCR-ABL to ABL <10^-3 or 0.1% on the international scale.~Complete molecular response (CMR): Complete absence of BCR-ABL or the ratio is <10^-4.5 or 0.00316% on the international scale.~Confirmed MMR or CMR = Criteria met again >6 weeks. BCR-ABL=the fused gene found in participants with this type of CML."|At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.||participants|||Number
158381|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 2/3 (Ph+ALL or AP/BP-CML)|"A participant is said to have a confirmed HR if criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.~Confirmed HR observed in stratum 2/3 was either CHR or MaHR or overall hematologic response (OHR).~Refer to Outcome Measure 19 for criteria for CHR and MaHR. OHR is defined as MaHR or MiHR. MiHR=CHRp except blasts in BM (≥ 5% and ≤ 15% blasts in BM). The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in stratum 2/3: Participants who received at least 1 dose of dasatinib 80 mg/m^2.||percentage of participants||95% Confidence Interval|Number
158382|NCT00306202|Secondary|Percentage of Participants With Confirmed Hematologic Response (HR) at Recommended Phase II Dose: Stratum 1 (Ph+ CP-CML)|"A participant was said to have a confirmed HR if all the criteria for HR were fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.~HR observed in stratum 1 was CHR. Refer to Outcome Measure 20 for criteria for CHR.~The Clopper and Pearson method was used to compute 95% exact CIs."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1 who received at least 1 dose of dasatinib 60 mg/m^2.||percentage of participants||95% Confidence Interval|Number
158383|NCT00306202|Secondary|Duration of Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of CHR is the time (in months) from the first day criteria were met for CHR, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval until death or progression was first observed. Refer to Outcome Measure 20 for criteria for CHR (Stratum 1) and Outcome Measure 19 for CHR (Stratum 2/3).~The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed CHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 50 months).|Treated participants with CHR in strata 1 and 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.||months||95% Confidence Interval|Median
158384|NCT00306202|Secondary|Duration of Major Hematologic Response (MaHR): Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Duration of MaHR is the time (in months) from the first day criteria were met for MaHR, provided they were confirmed later at least after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval, until death or progression was first observed.~MaHR: Defined as participants having as best response a CHR or CHRp. Refer to outcome measure 20 for criteria for CHR or CHRp. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first confirmed MaHR to date of progression, death, or last tumor assessment (maximum participant duration of response of 37 months).|All treated participants with MaHR in stratum 2/3. Participants who neither discontinued due to progression nor progressed nor died were censored on the date of their last hematologic or cytogenetic assessment, whichever came last.||months||95% Confidence Interval|Median
158385|NCT00306202|Secondary|Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML)|"Time to CHR is the time (in days) from first dose of dasatinib until the first day CHR criteria were met, provided they were confirmed later after 28 days with no concomitant use of anagrelide or hydroxyurea during this interval.~Refer to Outcome Measure 16 for criteria to CHR in Stratum 1 and to Outcome Measure 15 for criteria for CHR in Stratum 2/3.~Estimated by the Kaplan-Meier method and a 2-sided 95% CI for median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days).|All treated participants with CHR in strata 1 and 2/3.||days||95% Confidence Interval|Median
158386|NCT00306202|Secondary|Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML)|"Defined as time (in days) from first dose of dasatinib until the first day MaHR criteria were met, provided they were confirmed later (after 28 days) with no concomitant use of anagrelide or hydroxyurea during this interval.~MaHR: Defined as participants having as best response a CHR or CHRp. Refer to Outcome Measure 15 for criteria for CHR and CHRp. Estimated by the Kaplan-Meier method and a 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days).|Treated participants with MaHR in stratum 2/3.||days||95% Confidence Interval|Median
158387|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML)|HR was determined by CBC, differential, and platelet count. Unable to determine = Participants without any valid hematologic assessments.|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in stratum 4: Participants who received at least 1 dose of study therapy.||participants|||Number
158388|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM.~Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
158389|NCT00306202|Secondary|Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML)|"HR: Determined by complete blood count (CBC), differential, and platelet count (PLT). Criteria for complete hematologic response (CHR):~WBC in PB: <10,000/mm^3; Immature cells in PB: No blasts or promyelocytes (myelocytes + metamyelocytes) <5%; Basophils in PB: <5%; Platelet count (untransfused): <450,000/mm^3; Extra medullary disease: No extramedullary leukemia, including no splenomegaly.~Unconfirmed HR = All criteria met. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval."|Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63])|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.||participants|||Number
158390|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks|"Defined as participants having as best response a CHR or CHRp.~Criteria:~CHR-WBC in PB:≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).~CHRp-CHR except platelet count (untransfused) and ANC:20,000/mm^3 ≤platelet <100,000/mm^3 and /or 500/mm^3 ≤ANC ≤1000/mm^3."|After completion of Week 6 and 24 (measured at weeks 7 and 25)|All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
158391|NCT00306202|Secondary|Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)|"Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp).~Criteria:~CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm^3 and ≤450,000/mm^3; ANC:≥ 1000/mm^3; Blasts in BM:<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement).~CHRp-CHR except platelet count (untransfused) & ANC:20,000/mm^3 ≤platelet <100,000/mm^3 & /or 500/mm^3 ≤ANC ≤1000/mm^3."|Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.||participants|||Number
158392|NCT00306202|Secondary|Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]|"Defined as time (in months) from the first day that all criteria were met for CCyR until the date of progression (based on the Investigator’s assessment) or death (for participants whose best response was CCyR).~CCyR = 0% Ph+ metaphases of ≥ 20 analyzed metaphases in BM aspiration. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.||months||95% Confidence Interval|Median
158393|NCT00306202|Secondary|Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML])|"Defined as the time (in months) from the first day that all criteria were met for MCyR until the date of progression (based on the Investigator’s assessment) or death (for participants whose best responses were MCyR and CCyR respectively).~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% CI for the median was computed using the Brookmeyer and Crowley method."|From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months)|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment.||months||95% Confidence Interval|Median
158489|NCT00305162|Secondary|Incidence of All-cause Mortality||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
158394|NCT00306202|Secondary|Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|Defined as time (in days) from the first dose of dasatinib until criteria were first met for MCyR. MCyR: A CyR that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM. The Kaplan-Meier plot was used. A 2-sided, 95% confidence interval (CI) for the median was computed using the Brookmeyer and Crowley method.|Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days).|All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed & the number of Ph+ metaphases smaller than the total number of metaphases [%Ph+ <100%]) were considered responders.||days||95% Confidence Interval|Median
158395|NCT00306202|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||percentage of participants||95% Confidence Interval|Number
158396|NCT00306202|Secondary|Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample.~Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:>65%-95% Ph+ cells in metaphase in BM. No CyR:>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases [%Ph+ <100%])."|Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|"All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy.~Stratum 2/3 dasatinib 80 mg/m^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study."||participants|||Number
158397|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|After completion of Week 12 and 24 (measured at Weeks 13 and 25)|All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.||participants|||Number
158398|NCT00306202|Secondary|Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML)|"Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated.~MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR).~CCyR: 0% Ph+ cells in metaphase in BM. PCyR: >0% to 35% Ph+ cells in metaphase in BM."|Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])|All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.||participants|||Number
158399|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN. Total bilirubin:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
158400|NCT00306202|Secondary|Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=<LLN–8.0 mg/dL, GR2=<8.0–7.0 mg/dL, GR3=<7.0–6.0 mg/dL, GR4=<6.0 mg/dL; Low magnesium: GR1=<LLN–1.2 mg/dL, GR2=<1.2–0.9 mg/dL, GR3=<0.9–0.7 mg/dL, GR4=<0.7 mg/dL; Low phosphate: GR1=<LLN – 2.5 mg/dL, GR2=<2.5 – 2.0 mg/dL, GR3=<2.0 – 1.0 mg/dL, GR4=<1.0 mg/dL.|Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
158401|NCT00306202|Secondary|Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0|GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. WBC: GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. ANC: GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Hemoglobin: GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL; GR4=<6.5g/dL. Platelets: GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L; GR4=<25.0*10^9/L.|Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least one dose of study therapy.||participants|||Number
158490|NCT00305162|Secondary|Incidence of All-cause Mortality or MI|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
158402|NCT00306202|Secondary|Number of Participants With Dose-limiting Toxicity (DLT)|"DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:-~Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days~GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution~Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.||participants|||Number
158403|NCT00306202|Secondary|Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.|"AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization.~Grade 3 = Severe; Grade 4 = Life-threatening or disabling."|From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy.||participants|||Number
158404|NCT00306202|Primary|Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia|The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.|From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])|All treated participants: Participants who received at least 1 dose of study therapy||mg/m^2 QD|||Number
158405|NCT00306189|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|All subjects who received >= 1 dose of investigational product and have a baseline and >= 1 post baseline measurement at the lumbar spine.||Percent Change from Baseline||95% Confidence Interval|Mean
158406|NCT00306163|Secondary|Safety and Tolerability||5 weeks||||||
158407|NCT00306163|Secondary|Δ (FVC/SVC) at PC20 (AMP)|Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.|Baseline and 5 weeks||||||
158408|NCT00306163|Primary|PC20 AMP (Post-treatment Compared to Baseline)|Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron|Baseline and 5 weeks|The analyses on treatment effects were performed on all subjects who reached a PC20<640mg/mL.||Logarithm (mg/mL)||Standard Deviation|Mean
158409|NCT00305942|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.||Months||95% Confidence Interval|Median
158410|NCT00305942|Secondary|Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.|18 months|All patients were assessed for time to progression.||Months||95% Confidence Interval|Median
158411|NCT00305942|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.~The final response category assigned represented the best response obtained during treatment."|18 months|All patients were included in the analysis.||percentage of participants||95% Confidence Interval|Number
158412|NCT00305877|Secondary|Two-year Disease-free Survival (DFS)|Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).|Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years|Eligible and treated patients.||Proportion of patients||95% Confidence Interval|Number
158413|NCT00305877|Secondary|Two-year Overall Survival Rate|Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.|Assessed every 3 months for 2 years|Eligible and treated patients are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
158414|NCT00305877|Primary|Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy|"Specific toxicities to be monitored pursuant to the primary endpoint include:~Any grade 5 toxicities~Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension~Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis~ECOG performance status decline by 2 or greater for >24 hours~Weight loss >10%"|Every 2 weeks while on treatment and for 30 days after the end of treatment|All treated patients were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
158415|NCT00305864|Secondary|Progression-free Survival (Phase II)|Progression will be defined as a > 25% increase in tumor area.|From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.||||||
158536|NCT00303901|Primary|Local Failure Rates by CT Scan||at 3, 6, and 12 months|||% of participants with local recurrence||95% Confidence Interval|Number
158417|NCT00305864|Primary|Maximum Tolerated Dose of MGd (Phase I)|"Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the MTD. The MTD would be used for the Phase II arm.~Rating scale: 0 = not the MTD, 1 = MTD"|From start of radiation therapy to 90 days,|Eligible patients who received protocol treatment.||units on a scale|||Number
158418|NCT00305773|Other Pre-specified|Time to Treatment Failure (TTF)|Time to treatment failure (TTF) was defined as the time from registration to until the date of treatment discontinuation of any reason. Patients receiving treatment at the time of analysis were considered censored. The median TTF with 95% CI was estimated using the Kaplan Meier method.|Duration of treatment (up to 17 cycles)|||days||90% Confidence Interval|Median
158419|NCT00305773|Secondary|Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events|"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Duration of study (up to 2 years)|||participants|||Number
158420|NCT00305773|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Duration of study (up to 2 years)|||days||95% Confidence Interval|Median
158421|NCT00305773|Secondary|Time to Progression (TTP)|Time to Progression (TTP) for each patient will be calculated as the number of days from date of registration to either date when disease progression was documented or date of last evaluation without disease progression. The TTP distribution will be estimated using the method of Kaplan-Meier|Duration of study (up to 2 years)|This data was not (and will never be) analyzed. In place of this outcome, time to treatment failure, analyzed and reported as a secondary outcome.|||||
158422|NCT00305773|Primary|Confirmed Complete Response (CR) Rate|"The confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants.~According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC > 1500/mL, platelets > 100000/mL, no circulating blasts, bone marrow cellularity >20% (biopsy), trilineage maturation, < 5% bone marrow blasts, no auer rods and no extramedullary disease."|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
158423|NCT00305760|Primary|Safety of Combining the Pancreatic Tumor Vaccine in Sequence With Cyclophosphamide and Erbitux. Safety is Defined as the Number of Treatment-related Grade 3 or 4 Adverse Events Observed in Greater Than 5% of the Patient Population||Continuous|||Adverse Events|||Number
158424|NCT00305643|Secondary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on WHO Criteria.|A secondary classification of palmar planter erythrodysethesia according to World Health Organization (WHO) criteria will be used for determination of the incidences of > grade 1 HFS by 16 weeks from the commencement of therapy.|At 16 Weeks|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.|||||
158425|NCT00305643|Primary|Incidence of Hand/Foot Syndrome (HFS) > Grade 1 at 16 Weeks Based on the CTC 3.0 Criteria.|The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of > grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.|At 16 Weeks, with evaluations and blood test every 3 weeks.|No analysis could be performed due to low accrual and no participants reaching the 16 week mark.|||||
158426|NCT00305604|Secondary|Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week|Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.|Week 1|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Day 7, the last observed measurement was carried forward to Day 7. Patients had the option to participate in self monitoring of glucose.||mg/dL||95% Confidence Interval|Least Squares Mean
158427|NCT00305604|Secondary|Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
158428|NCT00305604|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
158429|NCT00305604|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and >= 1 post-baseline value for this outcome. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
158430|NCT00305578|Primary|Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks)|Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.|8 weeks|||units on a scale||Standard Deviation|Mean
158431|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
158432|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
158433|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
158434|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR mean change at week 22"|From baseline to Study Week 22|||units on a scale||Standard Deviation|Mean
158435|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
158436|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
158437|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
158438|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS mean change at week 22"|From baseline to Study Week 22|||units on a scale||Standard Deviation|Mean
158439|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
158440|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
158441|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
158442|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C mean change at week 22"|From baseline to Study Week 22|||units on a scale||Standard Deviation|Mean
158443|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean percent change at week 50"|From baseline to Study Week 50|||mean percent change||Standard Deviation|Mean
158444|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean change at week 50"|From baseline to Study Week 50|||units on a scale||Standard Deviation|Mean
158445|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Percent Change From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C mean percent change at week 22"|From baseline to Study Week 22|||mean percent change||Standard Deviation|Mean
158491|NCT00305162|Secondary|Incidence of All-cause Mortality, MI or IDR|(composite incidence)|randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
158446|NCT00305565|Post-Hoc|Regression Analysis of Change in MADRS Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline MADRS score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior ECT history, total number of adequate drug trials and prior medication regimen).~The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
158447|NCT00305565|Post-Hoc|Regression Analysis of Change in IDS-C Score vs. Total Charge Delivered Per Day|"Mixed models multivariate regression model was fitted for the outcome change from baseline IDS-C score as a function of log dose, where dose is measured by millicoulombs (mC), adjusting for other important covariates (e.g., visit number, total number of major depressive episodes, prior electroconvulsive therapy (ECT) history, total number of adequate drug trials and prior medication regimen).~The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes."|50 Weeks|50 Week Completers||Units on a scale per log(mC/Day)||Standard Error|Least Squares Mean
158448|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50|||percentage of participants|||Number
158449|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
158450|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22|||percentage of participants|||Number
158451|NCT00305565|Secondary|Inventory of Depressive Symptomatology Self-Report (IDS-SR) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-SR percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
158452|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 50 of the Long-term Phase (ITT Population).|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)~In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 50|||percentage of participants|||Number
158453|NCT00305565|Secondary|Clinical Global Impressions Improvement Scale (CGI-I) Percent Response at Week 22 of the Acute Phase (ITT Population)|"Originally, the Clinical Global Impressions-Improvement (CGI-I) (Guy W 1976)was designed as a 7-item scale used to assess how much the patient's illness had improved or worsened relative to a baseline state at the beginning of the intervention.(1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)~In this study, the CGI-I was categorized into just two groups. A value of 1 (considered a response) was assigned for very much improved (at least 85% improvement) & much improved (at least 60% improvement). A value of 0 (considered non-response) was assigned for: minimally improved (at least 20-25% improvement), no change (between ±15% change), minimally worse (at least 20-55% worse), much worse (at least 60% worse), and very much worse (at least 80% worse). No score was assigned if the investigator did not provide a categorical rating at a particular follow-up visit."|At Study Week 22|||percentage of participants|||Number
158454|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of remitters at week 50. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 50|||percentage of participants|||Number
158455|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the MADRS to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From Baseline to Study Week 50|||percentage of participants|||Number
158456|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
158457|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of remitters at week 22. Remission was defined as a score of less than or equal to 9 on the MADRS."|From baseline to Study Week 22|||percentage of participants|||Number
158458|NCT00305565|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 10-item Montgomery-Asberg Scale (Montgomery and Asberg 1979) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 60. Higher values are considered to be worse outcomes.~The MADRS percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
158459|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 50|||percentage of participants|||Number
158460|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
158461|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 5 on the QIDS-C."|From baseline to Study Week 22|||percentage of participants|||Number
158462|NCT00305565|Secondary|Quick Inventory of Depressive Symptomatology-Clinician Administered (QIDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 16-item Inventory of Depressive Symptomatology (QIDS) (Rush et al. 2003) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 27. Higher values are considered to be worse outcomes.~The QIDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
158463|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of remitters at week 50. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 50|||percentage of participants|||Number
158464|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Sustained Responders at Study Week 50 (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~Sustained Response is defined as the percentage of Acute Phase responders (week 22) who were also responders at the end of the Long-term (week 50) phase. An analysis of sustained response was performed using the IDS-C to evaluate the long-term durability of the improvements in depression scores observed with adjunctive VNS Therapy."|From baseline to Study Week 50|||percentage of participants|||Number
158465|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 50 of the Long-term Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of responders at week 50. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 50|||percentage of participants|||Number
158466|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Remitters From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of remitters at week 22. Remission was defined as a score of less than or equal to 14 on the IDS-C."|From baseline to Study Week 22|||percentage of participants|||Number
158467|NCT00305565|Secondary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Percent Responders From Baseline to Week 22 of the Acute Phase (ITT Population).|"The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.~The IDS-C percent of responders at week 22. Response was defined as greater than or equal to 50% improvement from baseline."|From baseline to Study Week 22|||percentage of participants|||Number
158537|NCT00303862|Secondary|eNOS|Endothelial nitric oxide synthase gene (eNOS). Record genotype=number of minor alleles.|Baseline (prior to therapy)|Because trial was closed due to poor accrual, assays were not performed.|||||
158468|NCT00305565|Primary|Inventory of Depressive Symptomatology-Clinician Administered (IDS-C) Mean Change From Baseline to Week 22 of the Acute Phase (ITT Population).|The 30-item Inventory of Depressive Symptomatology (IDS-C/SR) (Rush et al. 1986, 1996) is designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes.|From Baseline to Study Week 22|||units on a scale|Participants|Standard Error|Least Squares Mean
158469|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes|The measure of dispersion for volume of distribution is based on the inter-individual variance estimated for the apparent volume of plasma into which Fulvestrant distributes|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy.||Vss/F (L)||Standard Deviation|Mean
158470|NCT00305448|Secondary|Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body|The measure of dispersion for mean population clearance is based on the estimated inter-individual variance|Baseline to 12 weeks|Patients who agreed to participate in the PK substudy. The results are based on 148, 122 and 140 plasma-concentration records from patients in the 250 mg, 250 mg + LD and 500 mg treatment arms respectively.||L/h||Standard Deviation|Mean
158471|NCT00305448|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of Complete response (CR), Partial Response (PR) or Stable disease (SD) provided SD (or better) was present = 154 days from randomization (ie SD = 24 weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|every 12 weeks(+/- 2 weeks) from randomization to data up to data cut-off, 19th March 2008.|||percentage of participants|||Number
158472|NCT00305448|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.|RECIST tumour assessments carried out every 12 weeks from randomisation (+/- 2 weeks) until data cut-off on19th March 2008.||||||
158473|NCT00305448|Secondary|Time to Progression (TTP)|Time (in days) from randomization until objective disease progression or death (in the absence of objective progression). RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 19th March 2008.|every 12 weeks from randomization (+/- 2 weeks) until data cut-off (19th march 2008)|||days||Full Range|Median
158474|NCT00305448|Primary|Objective Response Rate (ORR)|"An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.~Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization"|baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)|||percentage of participants|||Number
158475|NCT00305344|Primary|Children With T1D Underwent a Single Autologous UCB Transfusion|All participants were monitored for 2 years. Baseline and post-infusion mixed meal tolerance tests were performed to determine whether autologous cord blood infusion preserved endogenous insulin production. The change in median area under the curve for C-peptide (measure of insuln production) from baseline to to 2 years during a 2 hour mixed meal tolerance test was used as the primary outcome measure and was reported in ng/ml/120 minutes|Baseline to Year 2|All participants received their own autologous umbilical cord blood (UCB)||ng /ml /120 min||Inter-Quartile Range|Median
158476|NCT00305253|Secondary|Emergency Hysterectomy|incidence of emergency hysterectomy for cases of uterine atony|within 72 hours of study enrollment|Data on emergency hysterectomy are only for women with diagnosis of uterine atony.||participants|||Number
158477|NCT00305253|Secondary|Blood Loss Due to Obstetric Hemorrhage|cumulative blood loss measured hourly upon study admission by calibrated blood collection drape|within 72 hours of study enrollment|Blood loss information was missing on some patients.||mL||Standard Deviation|Mean
158478|NCT00305253|Primary|Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)||from early pregnancy to within 3 weeks postpartum|All patients enrolled in the study were used in this analysis.||participants|||Number
158479|NCT00305227|Secondary|Incidence of Vaginal Discharge||4 mo||||||
158480|NCT00305227|Primary|Incidence of Urinary Tract Infection|Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.|10 weeks|The reported analysis was by intention to treat. All study participants were used, except for 4 participants in whom the major outcome measure was unevaluable.||participants|||Number
158481|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)|excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
158482|NCT00305162|Secondary|Incidence of ACUITY Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
158483|NCT00305162|Secondary|Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
158484|NCT00305162|Secondary|Incidence of GUSTO Severe / Life-threatening Bleeding|Major bleeding (non-CABG-related) - Safety population|randomization through 48 hours after randomization|Safety Population (inclusive of STEMI patients)||participants|||Number
158485|NCT00305162|Secondary|Incidence of All Cause Mortality|(excluding STEMI)|randomization through 1 year after randomization|mITT (excluding STEMI), based on 1 year completers||participants|||Number
158486|NCT00305162|Secondary|Incidence of Stroke||randomization through 30 days after randomization|mITT (excluding STEMI), based on available data||participants|||Number
158487|NCT00305162|Secondary|Incidence of IDR||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
158488|NCT00305162|Secondary|Incidence of MI||randomization through 30 days after randomization|mITT (excluding STEMI), based on 30-day completers||participants|||Number
158493|NCT00305162|Secondary|Incidence of Stroke|"Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:~primary hemorrhagic - stroke with focal collections of intracranial blood~ischemic cerebral infarction - stroke without focal collections of intracranial blood~infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding~uncertain - no imaging or autopsy data are available."|randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
158494|NCT00305162|Secondary|Individual Incidence of IDR||randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
158495|NCT00305162|Secondary|Individual Incidence of All-cause Mortality||randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
158496|NCT00305162|Secondary|Incidence of All-cause Mortality and MI|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
158497|NCT00305162|Primary|Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)|(composite incidence)|randomization through 48 hours after randomization|mITT (excluding STEMI)||participants|||Number
158498|NCT00304954|Secondary|Changes in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) From Baseline to 24 Weeks||Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7|||Microns|||Number
158499|NCT00304954|Secondary|Changes in Best-corrected Visual Acuity (BCVA) as Measured by the Standard Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol From Baseline to 24 Weeks|"The values in the table represent the denominator for the visual acuity in feet. A value of 20 represents normal 20/20 vision while increasing values for the denominator represent worsening vision."|Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7|||Feet|||Number
158500|NCT00304954|Primary|Monthly Rates of Anti-VEGF (Vascular Endothelial Growth Factor) Injections||24 Weeks|||Injections per Month||Full Range|Median
158501|NCT00304915|Primary|Percentage of Participants With Depression Treatment Response|Depression symptom severity over the past two weeks was measured using the Hopkins Symptom Checklist (SCL-20). The SCL-20 includes the 13-item depression scale plus 7 depression-related items from the Hopkins Symptom Checklist-90-Revised. The items are scored from 0 to 4 and averaged to provide a mean depression severity score from 0 to 4. Depression treatment response at 6-months was defined as a 50% decrease in mean SCL-20 score compared to baseline.|6 months|intent to treat analysis||percent response|||Number
158502|NCT00304746|Primary|21-item Hamilton Depression Rating Scale Score (HAM-D)|The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).|9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.||units on a scale||Standard Deviation|Mean
158503|NCT00304746|Secondary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).|9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)|All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.||units on a scale||Standard Deviation|Mean
158504|NCT00304265|Primary|Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine|"Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.~Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia."|Days 0 to 14 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Participants|||Number
158505|NCT00304187|Primary|Gastric Emptying Rate||Measured at Week 7||||||
158506|NCT00304187|Primary|Binge Frequency|Binge frequency wass assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.|Measured at Week 7|Participants for analysis included 13 patients in the erythromycin and 13 patients in the placebo group who completed at least 5 weeks of drug treatment.||Binge Episodes/Week||Standard Deviation|Mean
158507|NCT00304161|Secondary|Clinical Global Impression-Improvement Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale."|Week 8|||percentage of responders|||Number
158508|NCT00304161|Primary|Inventory of Depressive Symptomatology- Clinician Rated (IDS-C) Scale|The primary measure of depression symptom severity was the Inventory for Depressive Symptomatology–Clinician Rated (IDS-C), a 30-item (scores 0–84, increasing scores indicating greater depression severity) comprehensive instrument that is increasingly used as a primary outcome measure in major depression treatment studies in the general population. An IDS-C score of greater than or equal to 22 was indicative of at least moderate depression. The IDS-C was administered at every study visit. The criteria for the primary measure of treatment response was a >50% decrease in IDS-C score from baseline.|Week 8|||percentage of improved participants|||Number
158509|NCT00304096|Secondary|The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization||Days 1-78|||participants|||Number
158510|NCT00304096|Primary|The Number of Participants Who Experienced Dose-limiting Adverse Events|Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity|30 days post administration of last vaccine|||participants|||Number
158511|NCT00304031|Secondary|Correlation of PFS With OS at 6 Months||From randomization to date of progression, death or last follow-up. Analysis occurs after 647 deaths have been reported.||||||
158512|NCT00304031|Secondary|Toxicity||From start of treatment to end of follow-up||||||
158517|NCT00304031|Primary|Overall Survival (OS)||From randomization to date of death or last follow-up. Analysis occurs after 647 deaths have been reported.|Eligible patients who were randomized to an adjuvant temozolomide arm and contributed follow-up data.||months||95% Confidence Interval|Median
158518|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 18M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort C (18 Month) will be presented.|18 Month|||Percentage|Participants|Standard Deviation|Mean
158519|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 6M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort B (6 Month) will be presented.|6 Month|||Percentage|Participants|Standard Deviation|Mean
158520|NCT00303979|Secondary|Observe the Relative Improvement From Baseline to 24M in Composite Score for the Aggregate Practices.|Performance measure improvement for Composite Score analyzed at a practice level for Cohort A (longitudinal) will be presented.|24 months|||percentage|Participants|Standard Deviation|Mean
158521|NCT00303979|Secondary|Evaluate the Proportion of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline.|The proportion of practices that achieved greater than or equal to 20% improvement in two or more of the 7 performance measures at 24 months as compared to baseline will be presented.|Study Completion|||Sites|Participants||Number
158522|NCT00303979|Primary|To Observe Over the Aggregate IMPROVE-HF Practice Sites a Relative 20% or Greater Improvement in at Least 2 of the 7 Performance Measures at 24 Months Compared With Baseline.|The percent of patients that conformed to each performance measure will be calculated at baseline and 24 months. Based on the definition of each performance measure as defined in the performance measure constructs, each performance measure’s baseline percentage and 24 month percentage will be calculated. The change in percentages from baseline is the baseline percentage subtracted from the 24 month percentage. Each performance measure will be evaluated separately to determine whether there is a relative 20% or greater improvement from baseline. The difference in percentages from baseline to 24 months and associated 95% confidence intervals on the differences will be presented. The percent improvement from baseline for each performance measure will be tested using a large sample test (z-test) on a proportion.|24 Month|167 practices contributed data to the baseline chart review. Twelve of the practices withdrew from the study prior to the next chart review milestone. 155 of those practices’ data contributed to the follow up of the longitudinal cohort time points of 12 and 24 months post educational workshop.||Num. of measures with 20%+ improvement|||Number
158523|NCT00303966|Secondary|Changes in Plasma Level of Interleukin-8 (IL-8) From Baseline to Week 25|The change (post-pretreatment) will be calculated and tested using a paired t test. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early and enrolled only 5 patients. Data wasn't collected for this outcome.|||||
158524|NCT00303966|Secondary|Changes in Vascular Endothelial Growth Factor (VEGF) From Baseline to Week 25|Changes in VEGF levels (post-pretreatment) will be assessed. A negative value indicates a decrease with treatment.|Baseline and week 25|Study terminated early after enrolling only 5 patients. Data wasn't collected for this outcome.|||||
158525|NCT00303966|Secondary|Changes in Mean Microvessel Density From Baseline to Week 25|Mean microvessel density will serve as a marker of angiogenesis (other markers includes hot spot density). Will be examined using random-effects linear models.|Baseline and week 25|Study terminated early with only 5 patients. Data wasn't collected for this outcome.|||||
158526|NCT00303966|Primary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.||months||Standard Error|Median
158527|NCT00303966|Primary|Time to Disease Progression|Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.|Up to 5.5 years|Study terminated early and only 5 patients were enrolled.||months||Standard Error|Median
158528|NCT00303966|Primary|Objective Response Rate|Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with >50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).|Up to week 25|||percentage of participants||95% Confidence Interval|Number
158529|NCT00303953|Secondary|Progression-free Survival|Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|assessed at week 8, then every 3 months for 3 years|Only eligible patients were included in the analyses.||years||95% Confidence Interval|Median
158530|NCT00303953|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|assessed every 3 months for 3 years|Only eligible patients were included in the analyses.||years||95% Confidence Interval|Median
158531|NCT00303953|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|assessed at week 8, and every 3 months for 3 years|All eligible patients who started treatment were included in assessing response estimates.||participants|||Number
158532|NCT00303901|Primary|Distant Failure Rate||at 3, 6, and 12 months|||% of participants with distant failure||95% Confidence Interval|Number
158533|NCT00303901|Secondary|Point and Exact Confidence Interval Estimates of Patients Who Undergo Multiple Cryotherapy Procedures||12 months after the last patient was enrolled||||||
158545|NCT00303667|Secondary|Incidence of Post-transplant Lymphoproliferative Disorder (PTLD)|Post-transplant lymphoproliferative disorder (PTLD) is a virally-driven cancer of the lymphoid cells caused by immunosuppressive drugs taken after allogeneic stem cell transplantation to prevent or control graft versus host disease.|1 Year|||participants|||Number
158546|NCT00303667|Primary|Disease-free Survival at 1 Year|Number of patients alive without evidence of disease at 1 year after transplant|1 Year|||participants|||Number
158547|NCT00303667|Secondary|Number of Patients With Disease Relapse|Disease relapse is the recurrence of leukemia in patients who had cleared their leukemia after treatment. Patients with persistent leukemia are not evaluable for relapse.|1 Year|On the extended schema, 16/39 patients either did not clear their leukemia or died before relapse would have been detected (day 28), and thus were not evaluable for relapse.||participants|||Number
158548|NCT00303667|Secondary|Incidence of Chronic Graft Versus Host Disease|Chronic graft versus host disease is a severe long term complication created by infusion of donor cells into a foreign host|1 Year|||participants|||Number
158549|NCT00303667|Secondary|Number of Patients With Treatment-Related Mortality|Death within the first 100 days related to treatment in patients without relapse or persistent disease.|Day 100|||participants|||Number
158550|NCT00303667|Secondary|Incidence of Grade III-IV Acute Graft Versus Host Disease|Grade III-IV acute graft versus host disease is a severe short term complication created by infusion of donor cells into a foreign host|Month 6|||participants|||Number
158551|NCT00303667|Secondary|Number of Patients With Graft Failure|Number of patients with graft failure defined as <500 donor neutrophils count by day 28 in the absence of residual or relapsed leukemia|Day 28|On the short schema, 1 of the 8 patients, and on the extended schema, 6 of the 39 patients, died prior to Day 28, the day on which engraftment was assessed. Thus, only 7 and 33 patients respectively were evaluable for that endpoint.||participants|||Number
158552|NCT00303667|Secondary|In Vivo Expansion of a Donor NK Cells NK Cell Product|Number of patients with in vivo expansion of donor NK cells. In vivo expansion of NK cell is defined as detection of >100 donor-derived NK cells per microliter of blood.|12 - 14 days after NK cell infusion|The protocol was amended to add this endpoint after the 8 subjects were enrolled on the short schema. Thus the relevant samples to determine NK expansion were not collected. On the extended schema, 3 of 39 patients died prior to the day on which in vivo donor NK cell expansion was assessed. Thus only 36 patients were evaluable for that endpoint.||participants|||Number
158553|NCT00303667|Primary|Disease-free Survival at 6 Months|Number of patients alive without evidence of disease at 6 months after transplant|Month 6|||participants|||Number
158554|NCT00303628|Other Pre-specified|Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months|Change in oxaliplatin-related neurotoxicity between baseline and 12 months was measuring the long-term symptom of oxaliplatin-related neurotoxicity among the patients. Oxaliplatin-related neurotoxicity was measured using the FACT/GOG-Ntx subscale at baseline and 12 months after randomization. The range of the total score of the scale was between 0 and 44, and lower values indicate higher neurotoxicity. Change in oxaliplatin-related neurotoxicity between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated worsened symptom. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their oxaliplatin-related neurotoxicity measured using FACT/GOG Ntx subscale at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.||scores on a scale||Standard Deviation|Mean
158555|NCT00303628|Other Pre-specified|Change in Rectal Function Between Baseline and 12 Months|Change in rectal function between baseline and 12 months was measuring the long-term rectal function among the patients. Rectal function was measured using the Bowel Function Questionnaire at baseline and 12 months after randomization. The total score of the questionnaire was calculated as the number of problems with bowel function (score range 0-11). Change in rectal function between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated improved rectal function. This change in score was calculated for each individual patient who had the data.|assessed at baseline and 12 months after randomization|Patients with data about their rectal function measured using the Bowel Function Questionnaire at both baseline and 12 months after randomization. Due to the early termination of the trial, the sample size was quite small for the endpoint. Consequently, it was considered as an exploratory endpoint.||scores on a scale||Standard Deviation|Mean
158556|NCT00303628|Secondary|Proportion of Patients Who Completed 12 Cycles of Treatment|In the study, treatment was repeated every 2 weeks for a total of 12 cycles on both arms. The total number of cycles of treatment patient received until going off treatment due to any reason was recorded. It was a measure of the tolerance of the therapy.|assessed at the end of treatment|Patients who received at least one cycle of protocol treatment||proportion of participants|||Number
158557|NCT00303628|Secondary|Patterns of Failure|Failure included recurrence, second primary cancer and death without recurrence.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|all randomized patients||participants|||Number
158558|NCT00303628|Secondary|5-year Disease-free Survival Rate|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer or death, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Kaplan-Meier method was used to estimate 5-year DFS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)||proportion of participants||95% Confidence Interval|Number
158559|NCT00303628|Primary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate.|Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization|All randomized patients (intent-to-treat population)||proportion of participants||95% Confidence Interval|Number
158560|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale|Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
158561|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale|Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
158562|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
158563|NCT00303602|Secondary|Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint|Patient meets definition of metabolic syndrome if they have >=3 risk factors: Waist circumference (men>102cm, women>88cm); triglycerides >=1.7mmol/L; HDL cholesterol (men<1.04mmol/L, women<1.30mmol/L); blood pressure >135/>=85 mmHg; Fasting glucose >=6.1mmol/L|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||participants|||Number
158564|NCT00303602|Secondary|Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)|HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward.||percent sensitivity||Standard Deviation|Mean
158565|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin||Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||percent||Standard Deviation|Mean
158566|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin|Patients should be fasting a minimum of eight hours prior to serum insulin measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||microIU/milliliter||Standard Deviation|Mean
158567|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose|Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||millimole/Liter||Standard Deviation|Mean
158568|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)|Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||millimole/Liter||Standard Deviation|Mean
158569|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Blood Pressure|Sitting blood pressure, taken from the same arm.|Visit 2 (Baseline) and Visit 7 (Week 16)|Safety population with last observation carried forward||mm Hg||Standard Deviation|Mean
158570|NCT00303602|Secondary|Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale|Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat||units on a scale||Standard Error|Least Squares Mean
158571|NCT00303602|Secondary|Number of Participants Discontinuing the Trial by Visit (Week)|The number of participants who discontinued by visit (non-cumulative).|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat||participants|||Number
158572|NCT00303602|Secondary|Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period|Percentage loss of body weight = 100*(postbaseline weight - baseline weight)/baseline weight|Visit 2 (Baseline) to Visit 7 (Week 16)|Intention to treat||participants|||Number
158573|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Waist Circumference|Waist circumference is measured on a bare abodomen just above the hip bone.|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward||centimeters||Standard Deviation|Mean
158574|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Weight|Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Intention to treat||kilograms||Standard Error|Least Squares Mean
158575|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.|Visit 2 (Baseline) and Visit 7 (16 Weeks)|Per protocol||kilograms/square meters||Standard Deviation|Mean
158576|NCT00303602|Secondary|Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)|Visit 2 (Baseline) and Visit 7 (Week 16)|Intention to treat with last observation carried forward||kilograms/square meters||Standard Deviation|Mean
158577|NCT00303602|Primary|Time Course of Change From Baseline in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.|Visit 2 (Baseline) to Visit 7 (16 Weeks)|Intention to treat||kilograms/square meters||Standard Error|Least Squares Mean
158578|NCT00303511|Primary|Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead|The ability to place a pacemaker with capture (have the pacemaker work properly) through totally thoracoscopic approach to epicardial pacing lead without requiring conversion to open procedure|30 days|||percentage of particiapants|||Number
158579|NCT00303485|Secondary|Number of Participants With Any Adverse Event or Serious Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 7 months|The Safety Analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment.||Participants|||Number
158580|NCT00303485|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 – 550 *10^9/L), white blood cell (WBC) (3.0 - 18.0 *10^9/L), alanine aminotransferase (ALT) (0 – 110 U/L), creatinine (0 – 154 µmol/L), chloride (95 – 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ). Creatinine clearance was calculated using the Cockroft-Gault formula.|Up to 7 months|The Safety analysis Population was a subset of the ITT Population consisting of participants with at least 1 post-baseline safety assessment. ‘n’ denotes the number of participants who received the indicated study drug for each arm.||Participants|||Number
158581|NCT00303485|Secondary|Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations|Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.|Day (D)7, D14, D21 and D28 of Month 6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.||Percent change||Full Range|Median
158582|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.|Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percentage of participants|||Number
158583|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL|Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percentage of participants|||Number
158584|NCT00303485|Secondary|Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent|The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percentage of participants|||Number
158585|NCT00303485|Secondary|Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments|Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL). The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) * 100. Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7|Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.||Percent change||95% Confidence Interval|Median
158586|NCT00303485|Secondary|Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time|BSAP is a biochemical marker of bone formation and measured in units per litre (U/L). The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) * 100. The greater the percent decrease from Baseline, the greater the response to therapy. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. ‘n’ denotes number of participants who received the indicated study drug for each arm.||Percent change||95% Confidence Interval|Median
158612|NCT00303459|Secondary|Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16|Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.|From baseline to Week 16|All randomized set||participants|||Number
158587|NCT00303485|Secondary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time|sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication. “n” denotes number of participants who received the indicated study drug for each arm.||Percent change||95% Confidence Interval|Median
158588|NCT00303485|Primary|Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3|Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) * 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.|Baseline (Visit 1) and Day 3|This analysis was performed on the ITT Population. The ITT Population included all randomized participants who received at least 1 dose of study medication.||Percent change||95% Confidence Interval|Median
158589|NCT00303472|Primary|Part B: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part B.|Treatment period (8 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication||Participants|||Number
158590|NCT00303472|Primary|Part A: Number of Participants With Adverse Events|The number of participants experiencing one or more adverse events during the treatment phase or extension phase of Part A.|Treatment period (4 weeks) plus treatment extension (1 year)|All participants who received at least one dose of study medication||Participants|||Number
158591|NCT00303472|Secondary|Part B: Week 7 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 7|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||Hours||Full Range|Median
158592|NCT00303472|Secondary|Part B: Week 1 Tmax|Time at which the maximum concentration of romiplostum was observed after subcutaneous administration during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||Hours||Full Range|Median
158593|NCT00303472|Secondary|Part B: Week 7 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||hr*pg/mL||Standard Deviation|Mean
158594|NCT00303472|Secondary|Part B: Week 7 Ctrough|Measured romiplostim concentration at the end of the Week 7 dosing interval (Ctrough)|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
158595|NCT00303472|Secondary|Part B: Week 7 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 7.|Week 7|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
158596|NCT00303472|Secondary|Part B: Week 1 AUC0-4|Area under the romiplostim concentration-time curve from time zero to the last time point with quantifiable concentration (AUC0-4) during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||hr*pg/mL||Standard Deviation|Mean
158597|NCT00303472|Secondary|Part B: Week 1 Ctrough|Measured romiplostim concentration at the end of the week 1 dosing interval (Ctrough)|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
158598|NCT00303472|Secondary|Part B: Week 1 Cmax|Maximum observed serum concentration (Cmax) of romiplostim during Week 1|Week 1|Safety Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||pg/mL||Standard Deviation|Mean
158599|NCT00303472|Secondary|Part B: Duration of Platelet Response|Duration of platelet response per IWG criteria (absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks).|Treatment Period (8 weeks) and extension period (52 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who had a platelet response||Weeks||Inter-Quartile Range|Median
158600|NCT00303472|Secondary|Part B: Time to First Platelet Response|Participants achieving first platelet response according to IWG criteria, by study week. Platelet response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline ≤ 20 x 10^9/L increasing the platelet count to above 20 x 10^9/L and by at least 100% for 8 consecutive weeks. Platelet counts obtained within 72 hours of platelet transfusion were not evaluable for platelet response.|Treatment Period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase||Participants|||Number
158601|NCT00303472|Secondary|Part B: Peak Platelet Count|Peak platelet count (10^9/L) during the treatment period.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.||10^9/L||Inter-Quartile Range|Median
158672|NCT00303069|Primary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 14 Postvaccination||Baseline and Day 14 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.||Participants|||Number
158602|NCT00303472|Secondary|Part B: Number of Participants With a Platelet Response Per IWG|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (8 weeks) and extension period (52 weeks).|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase||Participants|||Number
158603|NCT00303472|Secondary|Part A: Number of Participants With a Platelet Response Per IWG Criteria|The number of participants with a platelet response according to the modified International Working Group (IWG) criteria. Response was defined as an absolute increase of ≥ 30 x 10^9/L with Baseline platelet count > 20 x 10^9/L, or with a Baseline count ≤ 20 x 10^9/L, increasing to above 20 x 10^9/L and by at least 100% during the treatment or extension period and maintained for at least 8 consecutive weeks. Platelet transfusion was not considered a rescue medication but platelet counts ≤72 hours after platelet transfusion were excluded from the analysis.|Treatment period (4 weeks) and extension period (52 weeks).|Subset of Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase, who entered the treatment extension.||Participants|||Number
158604|NCT00303472|Secondary|Part B: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (8 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.||Participants|||Number
158605|NCT00303472|Secondary|Part A: Number of Participants With a Complete or Major Platelet Response|Participants with a complete or major response during the treatment phase. A complete platelet response was defined as a platelet count ≥ 100 x 10^9/L during the treatment phase. A major platelet response was defined as an increase in absolute platelet count of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L platelets, or an increase from ≤ 20 x 10^9/L to > 20 x 10^9/L and by at least 100%. Any participant receiving rescue medication was considered a non-responder. Platelet transfusions were considered rescue medication.|Treatment Period (4 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received romiplostim and completed the treatment phase.||Participants|||Number
158606|NCT00303459|Secondary|Patient Global Self Assessment (PGSA) Status at Week 16|The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question “How do you feel about your PAH today compared with your last visit?” asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse.|Week 16|All randomized set, patients who completed the assessment||participants|||Number
158607|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with ‘best imaginable health state’ set at 100 and ‘worst imaginable health state’ set at 0.|Baseline to Week 16|All randomized set||units on a scale||Standard Deviation|Mean
158608|NCT00303459|Secondary|Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score|The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome).|From baseline to Week 16|All randomized set||units on a scale||Standard Deviation|Mean
158609|NCT00303459|Secondary|Change From Baseline to Week 16 in Borg Dyspnea Index|The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 (‘Nothing at all’) to 10 (‘Very, very severe – maximal’).|Baseline to Week 16|All randomized set||units on a scale||Standard Deviation|Mean
158610|NCT00303459|Secondary|Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP)|Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory.|Baseline to Month 20|All randomized patients with a baseline and at least one post-baseline value. Assessments considered are those where at least 60% of the patients have a post-baseline value||Adjusted percentage ratio from baseline||95% Confidence Interval|Geometric Mean
158611|NCT00303459|Secondary|Time to Death of All Causes From Baseline to End of Study|Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause.|Baseline to End of Study, approximately 86 months|All randomized set||percentage of participants-Kaplan Meier|||Number
158613|NCT00303459|Secondary|Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT)|The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period.|From baseline to week 16|All randomized set||m||Standard Deviation|Mean
158614|NCT00303459|Secondary|Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation|Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee.|Baseline to end of study, approximately 86 months|All randomized set||percentage of participants-Kaplan Meier|||Number
158615|NCT00303459|Primary|Time to First Confirmed Morbidity/Mortality Event up to the End of Study|"Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as moderately or markedly worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied no change or mildly worse on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event."|From baseline to end of study, approximately 86 months|All randomized set||percentage of participants-Kaplan Meier|||Number
158616|NCT00303446|Secondary|International Index for Erectile Function (IIEF), Change From Baseline|Sexual function was rated using the International Index of Erectile Function (IIEF). The total IIEF score (5-75, worst-best) was reported as the percent maximum (0-100%).|0, 12, and 24 months|||percent of maximum score||Standard Deviation|Mean
158617|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Mental Component Summary, Percent Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their mental quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10), and percent change in the norm-based scale was calculated.|0, 12, and 24 months|||percent change||Standard Deviation|Mean
158618|NCT00303446|Secondary|Medical Outcomes Study 36-item Short Form Version 2 (SF-36v2) Physical Component Summary, Change From Baseline|Subjects completed the Medical Outcomes Study Short Form Version 2 (SF-36v2), in which they rated their physical quality of life over the preceding 4 weeks. Raw SF-36v2 scores were converted to norm-based scales and component summaries using the scoring code provided by QualityMetric (mean=50, standard deviation (SD)=10).|0, 12, and 24 months|||percent change||Standard Deviation|Mean
158619|NCT00303446|Secondary|Activities of Daily Living, Change From Baseline|Subjects rated their daily activity with a modified 9-question Activities of Daily Living (ADL) questionnaire (0-4, fully impaired to normal).|0, 12, and 24 months|||units on a scale||Standard Deviation|Mean
158620|NCT00303446|Secondary|Motor Unit Nerve Estimation, Change From Baseline|Motor unit number estimation (MUNE) was done with a statistical MUNE program, on the abductor pollicis brevis. All subjects were evaluated on the right side unless severe atrophy produced very low compound muscle action potentials; in this case, the left side was investigated or the abductor digiti minimi was substituted. A decrease in MUNE indicates a loss of motor units.|0, 12, and 24 months|||motor unit number||Standard Deviation|Mean
158621|NCT00303446|Secondary|Peroneal Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the peroneal nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months|||mVolts||Standard Deviation|Mean
158622|NCT00303446|Secondary|Median Compound Muscle Action Potential, Change From Baseline|Nerve conduction studies were done on the median motor nerve, and the compound muscle action potential amplitude was determined. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months|||mVolts||Standard Deviation|Mean
158623|NCT00303446|Secondary|Sensory Nerve Action Potential Average, Change From Baseline|Nerve conduction studies were done on four sensory nerves (median, ulnar, radial, sural), and the amplitudes of the evoked responses were averaged. Loss of amplitude indicates impairment of conduction.|0, 12, and 24 months|||microVolts||Standard Deviation|Mean
158624|NCT00303446|Secondary|Bulbar Rating Scale, Change From Baseline|The Bulbar Rating Scale includes eight domains each rated on a 1-4 scale, abnormal to normal. The original 8-32 point scale was transformed to a 0-100% scale to represent the responses as percentages.|0, 12, and 24 months|||percentage of maximum score||Standard Deviation|Mean
158625|NCT00303446|Secondary|Swallow Score Average, Change From Baseline|Modified barium swallow studies were done at 0, 12, and 24 months. Twenty-five domains were assessed, and six were chosen for final analysis based on the abnormal findings in subjects evaluated at baseline: vallecular pooling and repeated-swallow, each assessed with thin liquids, purees, and solids (rated 1-4, abnormal to normal).|0, 12, and 24 months|||units on a scale||Standard Deviation|Mean
158626|NCT00303446|Secondary|Timed 2-minute Walk, Change From Baseline|The subjects did the 2-minute walk in a 50-foot (15.2-meter) corridor three times, and the average distance was calculated. The subjects were allowed to use an assistive device and rest between the trials.|0, 12, and 24 months|||meters||Standard Deviation|Mean
158627|NCT00303446|Secondary|Adult Myopathy Assessment Tool, Change From Baseline|The Adult Myopathy Assessment Tool rates physical function and muscle endurance, with higher scores indicating better performance; it includes 7 timed functional tasks and 6 endurance tasks (0=worst, 45=best).|0, 12, and 24 months|||units on a scale||Standard Deviation|Mean
158628|NCT00303446|Secondary|Manual Muscle Testing, Change From Baseline.|Manual muscle testing was performed using a modified Medical Research Council (MRC) scale (0=worst, 5=best); the average muscle score was based on 22 muscle groups.|0, 12, and 24 months|||MRC units on a scale||Standard Deviation|Mean
158629|NCT00303446|Secondary|Creatine Kinase, Change From Baseline|Serum creatine kinase was determined in venous blood samples analyzed at the Department of Laboratory Medicine of the NIH Clinical Center.|0, 12, and 24 months|||Units/liter||Standard Deviation|Mean
158703|NCT00302211|Other Pre-specified|Safety Objective|Assessment of the safety of the addition of iloprost inhlation solution in patients on oral sildenafil compared with placebo inhalation plus oral sildenafil. Safety variables observed were adverse events (AEs), laboratory data, and vitals.|Baseline up to 48 weeks||05/2010||||
158630|NCT00303446|Primary|Muscle Strength Change From Baseline|Quantitative muscle assessment (QMA) was done with a fixed frame dynamometer, a strain gauge tensiometer, and a computer-aided acquisition system. Maximal voluntary isometric muscle contractions were measured twice, the average was calculated, and the results were summed over 22 muscle groups (11 on each side). The total force was scaled for body weight and expressed as percent change from baseline. Measurements were performed at 0, 12, and 24 months. The calculated percent changes at 12 and 24 months are shown.|0, 12, and 24 months|The participants analyzed were those who were available for analysis at 12 and 24 months.||percent change||Standard Deviation|Mean
158631|NCT00303329|Secondary|The Absolute Change in Serum Ferritin (μg/L) Levels From Baseline to the End of the Study|Serum ferritin was monitored monthly and the dose of deferasirox was increased or decreased in steps of 5 to 10 mg/kg/day up to a maximum of 40 mg/kg/day if appropriate, every 3 months. If serum ferritin fell to 500 ng/mL or lower on two consecutive study visits, an interruption of treatment until serum ferritin was more than 500 ng/mL was considered.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||μg/L||Standard Deviation|Mean
158632|NCT00303329|Secondary|The Absolute Change in Liver Iron Content (LIC) as Assessed by Superconducting Quantum Interference Device (SQUID) From Baseline to End of Study|Liver iron concentration was monitored at the end of the core study and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant. Pediatric participants or participants with a medical contraindication to liver biopsy were allowed the use of SQUID in the extension study.|Core study Baseline to end of extension study (up to 60 months)|The FAS comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||mg Fe/g dw||Standard Deviation|Mean
158633|NCT00303329|Secondary|The Change in Liver Iron Content (LIC) as Assessed by Liver Biopsy at Baseline to the End of the Study|Liver iron concentration was monitored at the start of the core study, the end of the core study, and then at the end of the extension study. High-risk participants, like participants with rare anemia, were excluded from any further potential liver biopsy, except if required and justified by the Investigator for the general care of the participant.|Core study Baseline to end of extension study (up to 60 months)|The full analysis Set (FAS) comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||mg Fe/g dw||Standard Deviation|Mean
158634|NCT00303329|Primary|The Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Core study Baseline to the end of the study (up to 60 months)|The safety analysis set comprised all participants who received at least one dose of deferasirox during either the core or extension studies.||Participants|||Number
158635|NCT00303316|Primary|Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|"Antibody titers determination:~Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay."|Day 0 (pre-booster) and Day 30 post-booster|Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).||Titers||95% Confidence Interval|Geometric Mean
158636|NCT00303316|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable."|Day 0 up to Day 30 post-booster vaccination|Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.||Participants|||Number
158637|NCT00303316|Primary|Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.|Day 30 Post-booster Vaccination|Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).||Participants|||Number
158638|NCT00303316|Primary|Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.|Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).|Day 0 (Before booster vaccination)|Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).||Participants|||Number
158670|NCT00303108|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Evaluable population||percentage of participants||95% Confidence Interval|Number
158639|NCT00303186|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158640|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
158641|NCT00303186|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158642|NCT00303186|Secondary|Health Assessment Questionnaire (HAQ)|HAQ: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158643|NCT00303186|Secondary|Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; if stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.||minutes||Standard Deviation|Mean
158644|NCT00303186|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||milligram/deciliter (mg/dL)||Standard Deviation|Mean
158645|NCT00303186|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm/hr||Standard Deviation|Mean
158646|NCT00303186|Secondary|Visual Analogue Scale for Pain (VAS-pain)|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
158647|NCT00303186|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
158648|NCT00303186|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Measured using a 100 millimeter (mm) VAS ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||mm||Standard Deviation|Mean
158649|NCT00303186|Secondary|Radiographic Score Based on Wassenberg|Radiographic score based on wassenberg consisted of 2 sub-scores, proliferation score (PS) assessing bone proliferation and destruction score (DS) assessing joint surface destruction. Score range for PS and DS was 0 to 160 (where higher score represented higher bone proliferation) and 0 to 200 (where higher score represented higher destruction), respectively. Total score = sum of PS and DS (range 0 to 360); higher score represented worse state.|Baseline, Month 12, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158650|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||percentage of participants|||Number
158651|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||percentage of participants|||Number
158652|NCT00303186|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||percentage of participants|||Number
158653|NCT00303186|Secondary|Number of Swollen and Tender Joints|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||joints||Standard Deviation|Mean
158654|NCT00303186|Secondary|Maastricht Ankylosing Spondylitis Enthesis Score (MASES)|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158655|NCT00303186|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||cm||Standard Deviation|Mean
158656|NCT00303186|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line).|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||cm||Standard Deviation|Mean
158657|NCT00303186|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bend forward, knees fully extended, with spine in full flexion.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||cm||Standard Deviation|Mean
158658|NCT00303186|Secondary|Bath Ankylosing Spondylitis Radiology Index (BASRI)|BASRI- Radiographs of participants with AS were scored using the New York criteria for the sacroiliac joints on a scale of 2 to 4, the lumbar and cervical spine on a scale of 0 to 4 (0 = normal, 1 = suspicious, 2 = mild, 3 = moderate, 4 = severe). These 3 scores were added together to produce the BASRI-spine (BASRI-s) score (range 2 to 12). Similarly, hip joints were scored on a scale of 0 to 4 to give BASRI-hip (BASRI-h). Sum of BASRI-s and BASRI-h produced BASRI-total (BASRI-t) score; total range 2 to 16, higher score represented worse health state.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|Data was not statistically analyzed because of insufficient data collected and small sample size achieved.||units on a scale||Standard Deviation|Mean
158659|NCT00303186|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158660|NCT00303186|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a Visual Analog Scale (VAS) of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions. Total possible score range: 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158661|NCT00303186|Secondary|Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||units on a scale||Standard Deviation|Mean
158662|NCT00303186|Secondary|Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)|PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||participants|||Number
158663|NCT00303186|Secondary|Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change >= 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Month 6, Month 12, Month 18, Month 24, Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'n' is signifying those participants who were evaluated for this measure at the given time points.||participants|||Number
158664|NCT00303186|Primary|Incremental Cost-effectiveness Ratio (ICER)|ICER: ratio of the incremental cost of treatment over the incremental effectiveness. Incremental cost = difference in cost between baseline and month 60. Effectiveness was defined as quality adjusted life year (QALY) gained, i.e. difference in Euro Quality of Life 5 Dimension (EQ-5D)- health state profile utility score between baseline and month 60. (EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Total score range -0.594 to 1.000; higher score indicates a better health state.)|Baseline up to Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||ratio||95% Confidence Interval|Number
158665|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 60|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 60|ITT population included all participants who received at least 1 dose of the study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.||Euro/participant-month||Standard Deviation|Mean
158666|NCT00303186|Primary|Mean Cost Per Participant Per Month at Month 12|Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.|Month 12|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.||Euro/participant-month||Standard Deviation|Mean
158667|NCT00303108|Secondary|1-year Overall Survival|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|1 year|ITT population||probability of overall survival||95% Confidence Interval|Number
158668|NCT00303108|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of “non-target” lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel."|30 months|ITT population||months||Full Range|Median
158669|NCT00303108|Secondary|Duration of Response|Duration from date of stating treatment to the date of first CR or PR.|From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.|Patients who achieved CR or PR.||months||Full Range|Median
158671|NCT00303069|Secondary|Number of Participants With ≥2-fold Rise in Antibody Titer From Baseline at Day 7 Postvaccination||Baseline and Day 7 postvaccination|The population analyzed was the per-protocol population, excluding subjects identified as protocol violators. Subjects who were found to have deviated from the protocol procedures were evaluated to determine if they should be excluded from the per-protocol analyses. These evaluations were made prior to study unblinding on a case by case basis.||Participants|||Number
158673|NCT00303069|Primary|Number of Vaccine-related Serious Adverse Experiences Following Vaccination|Participants with a serious vaccine-related adverse experiences (AE) (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|Through Day 84 postvaccination|The population analyzed included all subjects who were randomized, vaccinated, and had safety follow-up.||Participants|||Number
158674|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||fL||Standard Deviation|Mean
158675|NCT00302952|Primary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||pg||Standard Deviation|Mean
158676|NCT00302952|Primary|Change From Baseline in Red Cell Distribution Width (RDW) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||% of mean corpuscle volume||Standard Deviation|Mean
158677|NCT00302952|Primary|Change From Baseline in Hematocrit (Hct) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||% of packed red blood cells by volume||Standard Deviation|Mean
158678|NCT00302952|Primary|Change From Baseline in Counts: White Blood Cells (WBC), Neutrophils, Bands, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, and Reticulocytes at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||10^3/uL||Standard Deviation|Mean
158679|NCT00302952|Primary|Change From Baseline in CPK at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||U/L||Standard Deviation|Mean
158680|NCT00302952|Primary|Change From Baseline in Potassium, Sodium, Chloride, and Total CO2 at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||mmol/L||Standard Deviation|Mean
158681|NCT00302952|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscular Hemoglobin Concentration (MCHC) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||g/dL||Standard Deviation|Mean
158682|NCT00302952|Primary|Change From Baseline in Total Bilirubin, Creatinine, BUN, Phosphorus, Calcium, and Glucose at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||mg/dL||Standard Deviation|Mean
158683|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum Anti-cyclic Citrullinated Peptide (Anti-CCP) by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Anti-CCP antibodies are autoantibodies frequently detected in the serum of individuals with rheumatoid arthritis. In this study, a positive value for anti-CCP was 8 IU/mL or greater; a negative value for anti-CCP was <8 IU/mL. Change= subtraction of Day 0 from Day 84 anti-CCP value. In general, high levels of the antibody indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline ( Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data||IU/mL||Standard Error|Mean
158684|NCT00302952|Secondary|Adjusted Mean Change From Baseline in Serum IgM Rheumatoid Factor by ELISA (ELISA: Enzyme-linked Immunosorbent Assay)|Rheumatoid factor (RF) is an antibody often present in the blood of a person with rheumatoid arthritis. In this study, a positive value for RF was 0.5 IU/mL or greater; a negative value for RF was <0.5 IU/mL. Change= Day 84 value minus Baseline value. In general, presence of the antibody indicates aggressive rheumatoid arthritis and higher risk of joint damage. Participants with measurements for designated time points included in analysis.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with Available Data||IU/mL||Standard Error|Mean
158685|NCT00302952|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Day 84 (ACR: American College of Rheumatology)|Patients were ACR20 Responders if they had: at least 20% improvement in both tender joint count (28 examined) and swollen joint count (28 examined), and 20% improvement in at least three of the following 5 remaining ACR core measures: • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) • Patient's global assessment of disease activity (VAS 100 mm) • Physician's global assessment of disease activity (VAS 100 mm) • Patient self-assessed disability (Health Assessment Questionnaire (HAQ)) score • Acute phase reactant C-reactive protein. Participants with measurements for designated time points were included in analysis.|Day 84 (Wk 12)|Intent-to-Treat with Available Data||Percentage of participants|||Number
158686|NCT00302952|Secondary|Adjusted Mean Change From Baseline in the Disease Activity Score Using C-reactive Protein (DAS28-CRP) on Day 84|The DAS28-CRP score is on a scale of 0 to 10 and indicates current activity of rheumatoid arthritis (>5.1=high disease activity; 3.2-<=5.1=moderate disease activity; <=3.2=low disease activity; <2.6=remission). The score uses a combination of four variables: 1) the number of tender joints (of the 28 that are measured); 2) the number of swollen joints (of the 28 that are measured); 3) serum C-reactive protein (CRP) lab value in mg/L , and 4) Patient Global Assessment of Disease Activity. Using a formula, the physician determines the score. Participants with measurements for designated time points included in analysis.|Baseline (Day 0) to Day 84 (Wk 12)|Intent-to-Treat with Available Data||Scores on a scale||Standard Error|Mean
158687|NCT00302952|Primary|Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at Day 84|Blood samples were taken from participants at Baseline and Day 84. Participants with measurements for designated time points included in analysis. Change=Day 84 value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values. Reference: http://www.merckmanuals.com/professional/appendixes/normal_laboratory_values/blood_tests_normal_values.html|Baseline (Day 0), Day 84 (Wk 12)|Safety||U/L||Standard Deviation|Mean
158688|NCT00302952|Primary|Adjusted Mean Change From Baseline in Log Transformed C - Reactive Protein (CRP) at Day 84|Blood draw for CRP, an acute phase reactant used to identify the presence of nonspecific inflammation. Change=Day 84 value minus Baseline value. Normal serum CRP reference range in this study is 0-4 mg/L (log transformed: -4.2 to 1.4). Participants with measurements for designated time points were included in analysis. An increased CRP level indicates the presence of inflammation. Reduced CRP levels could mean a decrease in inflammation.|Baseline (Day 0), Day 84 (Wk 12)|Intent-to-Treat with available data||mg/L||Standard Error|Mean
158689|NCT00302848|Primary|Number of Participants With Venous Thromboembolism (VTE)||1.5 to 5 years|"The primary analysis compares the users of DRSP and LNG. Its results are presented below. The comparison of users of DRSP and OCs containing other progestins was only conducted for exploratory reasons. This secondary analysis showed similar results and is described in more detail in the publication of study results, see citations."||Participants|||Number
158690|NCT00302718|Post-Hoc|Incidence of Hypotension Among All Patients With Hypertension|Patients had at least one primary care encounter during the interval assessed. We looked four months from the encounter for evidence of hypotension, either an outpatient systolic blood pressure (BP) < 90 mm Hg, an outpatient diagnosis of hypotension, or both. We combined the intervention arms (physician-level, practice group-level, and combined physician and practice group-level incentives) into one arm due to low frequency of events and low power.|February-May 2009|All patients with hypertension from the physicians' panel who had an outpatient encounter between February and May 2009. We used data from automated processing of structured fields from electronic health records to evaluate this measure.||percentage of all hypertensive patients|Participants||Number
158691|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
158702|NCT00302211|Primary|Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) in Double-blind, Modified Intent To Treat (MITT) Population|Comparing number of Modified Intent to Treat population in double-blind who improved in the 6-minute walk distance - from baseline distance between 100-450 meters. Any increase in walk distance was considered improvement from baseline. The 6-minute walks were measured in meters using a test administrator, a stop watch, and markers to identify the course.|Day 1 to Week 16|||participants|||Number
158692|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
158693|NCT00302718|Primary|Proportion of Physicians' Patients Prescribed Guideline-recommended Antihypertensive Medications|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to evaluate use of guideline-recommended antihypertensive medications. Assessing use of guideline-recommended medications included collecting information about the patient's compelling conditions (e.g., diabetes mellitus) as well as allergies and refusals to antihypertensive medications."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
158694|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the post-washout performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|After the washout period (May-August 2011)|The number of physicians listed is those who participated in the post-washout performance period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
158695|NCT00302718|Primary|Proportion of Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the fifth and final intervention performance period. Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Final intervention period (April-July 2009)|The number of physicians listed is those who participated in the final intervention period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
158696|NCT00302718|Secondary|Colorectal Cancer (CRC) Screening, Low-density Lipoprotein (LDL) Cholesterol Levels, Hemoglobin (Hb) A1c Levels, and Beta Blocker Use||Secondary outcomes measured for baseline period, during the intervention period, and the post-washout period||||||
158697|NCT00302718|Primary|Proportion of the Physicians' Patients With Blood Pressure Control or Appropriate Response to Uncontrolled Blood Pressure|"This measure reports the unadjusted proportion of physicians' patients meeting the study outcome for the first performance period (baseline). Data are based on review of the electronic health records for 40 patients with hypertension randomly selected from each physician's panel. We used the guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) to determine if the physicians' patients achieved the recommended blood pressures thresholds and if providers appropriately responded to uncontrolled blood pressure. Appropriate responses included increasing the dosage of a guideline-recommended antihypertensive medication or recommending a lifestyle modification to patient with Stage 1 hypertension."|Baseline period (August-November 2007)|The number of physicians listed is those who participated in the baseline period. The participant flow diagram describes the final number of physicians who received at least two instances of the intervention and were included in the repeated-measures longitudinal analysis.||percentage of physicians' patients|Participants||Number
158698|NCT00302458|Primary|Peak Plasma Concentration of d-Methylphenidate|Objective measure determined from blood samples, measured 4 hours after the dose|4 hours|All subjects received each combination of medications on a separate day (total= 5 days)||mg/L||Standard Deviation|Mean
158699|NCT00302328|Secondary|Visual Field Defects|visual field defects measured on humphrey perimetry|6 months|from predetermined power analysis||participants|||Number
158700|NCT00302328|Secondary|Anatomic Success|closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)|macular hole closure at 12 months|from initial power calculation of primary end point||participants|||Number
158701|NCT00302328|Primary|Visual Acuity (ETDRS Letters)|Visual acuity measured as the number of ETDRS letters at last follow-up|Visual acuity at 12 months|Decided from initial power calculation||Visual acuity in letters||Standard Error|Mean
158704|NCT00302211|Secondary|Assess the Efficacy of the Addition of Inhaled Iloprost in Patients With PAH Receiving a Stable Dose of Oral Sildenafil|The change in 6-minute walk distance (6-MWD) measured after inhalation, following 16 weeks of combination therapy with inhaled iloprost (administered 6 times or 4 times per day) inhaled iloprost plus sildenafil during the open-label extension phase.|Baseline Week 16 up to 48 weeks||05/2010||||
158705|NCT00302159|Primary|Percentage of Participants With Overall Survival at 6, 12, and 24 Months|Percentage of participants who were alive at 6, 12, and 24 months.|6, 12, and 24 months|||percentage of participants|||Number
158706|NCT00302159|Primary|Median Overall Survival|Survival is the interval from the initiation of treatment on protocol to date of death.|up to 63.8 months|||months||95% Confidence Interval|Median
158707|NCT00302159|Primary|Number of Participants With Best Response|Best response recorded from the start of treatment until disease progression/recurrence. Complete response is complete resolution of all contrast enhancing tumor documented at initiation of treatment on protocol, with no appearance of new lesions. Partial response is a >50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Minor response is a >25%, but <50% reduction in the contrast enhancing tumor volume documented at the initiation of treatment on protocol. Stable disease is a change in tumor size less than MR but not demonstrating progressive disease. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol. Not evaluable means the participant cannot be evaluated (e.g., quality of scan).|up to 63.8 months|||participants|||Number
158708|NCT00302159|Primary|Percentage of Participants With Progression Free Survival at 6, 12, and 24 Months|Percentage of participants who were progression free by 6, 12, or 24 months. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|6, 12, and 24 months|||percentage of participants|||Number
158709|NCT00302159|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|6 years, 7 months and 27 days|||participants|||Number
158710|NCT00302159|Primary|Median Progression Free Survival.|Progression free survival is the interval from initiation of treatment on protocol to symptomatic or radiographic progression. Progressive disease is a >25% increase in contrast enhancing tumor volume documented at the initiation of treatment on protocol.|up to 51 months|||months||95% Confidence Interval|Median
158711|NCT00302133|Secondary|% Subjects Abstinent|Proportion of subjects abstinent during the last 4 weeks of the trial|12 weeks|||percentage of participants|||Number
158712|NCT00302133|Primary|Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial||12 weeks|One subject in the naltrexone group was considered an outlier and excluded from the analysis as it will disproportionally skew the results of small sample size, and one subject in the placebo group was lost to follow-up immediately after group allocation and before any first post allocation assessment.||standard drinks/drinking day||Standard Deviation|Mean
158713|NCT00302107|Primary|Structured Interview of Posttraumatic Stress Disorder (SIP)|Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).|Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.|Randomized, took at least one dose of study medication, and returned for at least one visit post-randomization||units on a scale||Standard Deviation|Mean
158714|NCT00302081|Secondary|Virologic Response Rates at the End of Therapy. Biochemical Responses as Determined by ALT and AST Levels at the End of Treatment and at the End of Follow up.|"Virologic response is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) in the serum. A blood test is used to measure the level of ALT and AST. ALT response was defined as ALT<40 IU/L (international units per liter).~This was not a prespecified key secondary outcome."|End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm.||||||
158715|NCT00302081|Primary|The Number of Participants Who Achieve a Sustained Virologic Response (SVR)|A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid [HCV-RNA] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.|24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.|Intent-to-Treat (ITT) population||participants|||Number
158716|NCT00302068|Secondary|Interleuken 6 (IL-6)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||pg/ml||Standard Deviation|Mean
158717|NCT00302068|Secondary|Baroreflex Sensitivity (BRS)||Baseline, 16 weeks|Analysis based on 92 participants with valid baseline measurement.||msec/mmHg||Standard Deviation|Mean
158718|NCT00302068|Secondary|Platelet Factor 4||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||IU/ml||Standard Deviation|Mean
158719|NCT00302068|Secondary|C-reactive Protein (CRP)||Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||ug/ml||Standard Deviation|Mean
158757|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|18 patients from Epithelian Ovarian Cancer patients were analyzed||participants|||Number
158720|NCT00302068|Secondary|Percent Change in Flow Mediated Dilation (FMD)|Endothelial function assessed by flow mediated dilation (FMD). Brachial artery FMD was assessed following overnight fasting. Longitudinal B-mode ultrasound images of the brachial artery, 4-6 cm proximal to the antecubital crease, were obtained using an Aeuson (Mountain View, California) Aspen ultrasoundplatformwith an 11MHZ linear array transducer. lmages were obtained after 10 min of supine relaxation and during reactive hyperemia, induced following in ation of a forearm pneumatic occlusion cuff to supra-systolic pressure (~200 mmHg) for 5 minutes. FMD was defined as the maximum percent change inarterial diameter relative to restingbaseline from 10-120 sec post-deflation of the occlusion cuff.|Baseline, 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||percentage change|||Number
158721|NCT00302068|Secondary|Heart Rate Variability (HRV)|HRV is the variation in the time interval between heart beats. ECG was recorded for 24 hours on a 3-channel digital compact ash Holter recorder. During the recording period, patients engaged in their normal patterns of activity. ECG data were downloaded and edited using the Pathfinder digital ambulatory ECG analyzer (DelMar Reynolds, lrvine, California) and HRV was estimated from the standard deviation of all normal R—R intervals (SDNN)|Baseline, 16 weeks|Analysis based on 93 participants with valid baseline measurements.||millisecond||Standard Deviation|Mean
158722|NCT00302068|Primary|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale ranges from 0 to 52, with lower scores reflecting lower levels of depression and higher scores greater severity of depression.|Measured at 16 weeks|All completed subjects plus 1 subject in the sertraline arm who did not complete but provided assessment data.||Raw changes in Ham-D scores||95% Confidence Interval|Mean
158723|NCT00302055|Secondary|Rate of Community Program Participation||6 months||||||
158724|NCT00302055|Secondary|Self Report Physical Activity||12 months||||||
158725|NCT00302055|Primary|Weight Loss|We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)|12 months|||kilograms||95% Confidence Interval|Mean
158726|NCT00302042|Secondary|Change in Dietary Composition||Baseline, 6 months||||||
158727|NCT00302042|Secondary|Rate of Community Program Participation||Baseline, 6 months||||||
158728|NCT00302042|Secondary|Physical Activity Level||Baseline, 6 months||||||
158729|NCT00302042|Primary|Change in Weight|6 months minus baseline|Baseline, 6 months|||percentage of change in weight||95% Confidence Interval|Mean
158730|NCT00302003|Secondary|Overall Survival|Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.|At 60 months|Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).||Probability of survival||95% Confidence Interval|Number
158731|NCT00302003|Primary|Event Free Survival (EFS)|Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).|At 60 months|Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).||Probability of survival||95% Confidence Interval|Number
158732|NCT00302003|Primary|Intensive Therapy Free Survival (ITFS).|Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).||Probability of survival||95% Confidence Interval|Number
158733|NCT00302003|Primary|Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).|Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).|At 60 months|Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).||Probability of survival||95% Confidence Interval|Number
158734|NCT00301964|Secondary|Initial Performance Status and Histological Grade||Up to 5 years||||||
158735|NCT00301964|Secondary|Overall Survival|Characterized graphically and using descriptive statistics.|From entry into the study to death or the date of last contact, assessed up to 5 years||||||
158736|NCT00301964|Secondary|Progression-free Survival|Characterized graphically and using descriptive statistics.|From study entry until disease progression, death or date of last contact, assessed up to 5 years||||||
158737|NCT00301964|Primary|Severity of Adverse Events as Assessed by CTCAE Version 3.0||Up to 5 years||||||
158738|NCT00301964|Primary|Frequency of Adverse Effects||Up to 5 years||||||
158758|NCT00301756|Secondary|Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years|||months||95% Confidence Interval|Median
158759|NCT00301756|Other Pre-specified|Relationship Between Clinical and Pharmacodynamic Effects of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors|Summarized using summary statistics, such as the mean, median, and range. Tested using one-sample t-tests or Wilcoxon rank sum tests. Logistic regression analysis will be used to test significance.|Up to 5 years||||||
158739|NCT00301964|Primary|Best Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|study entry through completion|Total number eligible and evaluable participants||participants|||Number
158740|NCT00301964|Primary|Progression-free Survival Greater Than 6 Months|Disease Progression is at least a 20% increase in the sum of longest dimension (LD) of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|6 months|Total number of eligible and evaluable participants||participants|||Number
158741|NCT00301873|Secondary|Mean Change in Bone Mass Density (BMD)|Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person’s bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.|6 & 12 months|59 patients were accrued to the study; however follow-up at 6 months was available from 27 patients and at 12 months data was available from 19 patients.||T score units||Standard Deviation|Mean
158742|NCT00301873|Secondary|Skeletal-related Complications|Number of patients who experience skeletal-related complications during the administration of Zoledronate.|1 year|All patients.||participants|||Number
158743|NCT00301873|Primary|Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.|Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person’s bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.|6 and 12 months|59 patients were accrued; however only 27 had a follow-up assessment at 6 months and 19 at 12 months.||percentage of patients|||Number
158744|NCT00301834|Secondary|Disease-free Survival With Correction of Disease at One Year Post Transplantation|"Patients deemed alive and well at follow-up timepoint later than 1-year post-transplantation"|1 year post-transplantation|||participants|||Number
158745|NCT00301834|Secondary|Cytomegalovirus (CMV) Viral Infection and Disease Symptoms|polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) > 200 cells/mm3. Median time to T-cell reconstitution was 6 months.|Up to one year post-transplant|4 participants were incapable of producing Ab or CMV testing result was indeterminate||participants|||Number
158746|NCT00301834|Secondary|Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation||1 year post-transplantation|||participants|||Number
158747|NCT00301834|Secondary|Treatment-related Mortality at 100 Days and 1 Year Post Transplantation||100 days and 1 year|||participants|||Number
158748|NCT00301834|Primary|Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation|Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences|6 weeks post-transplant|Participants evaluable for engraftment 6 weeks post-transplant; 1 patient died of transplant-related hemorrhage prior to 6 weeks and was not evaluated for this outcome||participants|||Number
158749|NCT00301821|Secondary|Overall Response Rate (ORR)|Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|Baseline to first 6 cycles of treatment|Out of the 107 patients enrolled, Twenty-five patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.||percentage of participants|||Number
158750|NCT00301821|Secondary|Progression-free Survival (PFS)|Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.|the time from study entry to 36 months|Intent To Treat (All Patients)||percentage of participants|||Number
158751|NCT00301821|Secondary|Overall Survival|Percentage of participants alive at different time points|time from study entry to 36 months|Intent To Treat (All Patients)||percentage of Participants|||Number
158752|NCT00301821|Primary|Event-free Survival After 12 Months|The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).|From Baseline to 12 months|First 76 eligible participants were included in this analysis.||percentage of participants|||Number
158753|NCT00301808|Secondary|Toxicity||72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year||||||
158754|NCT00301808|Secondary|Overall Survival||Date of registration to the date of death||||||
158755|NCT00301808|Secondary|Progression-free Survival||Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.||||||
158756|NCT00301808|Primary|Probability of Overall Survival at One Year|Using Kaplan-Meier product-limit analysis|at 1 year|||probability of overall survival||95% Confidence Interval|Number
158760|NCT00301756|Secondary|Safety and Tolerability of Belinostat in Patients With Platinum Resistant and Micropapillary/ Borderline Ovarian Tumors|Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Tabulated using counts and proportions detailing frequently occurring, serious and related events of interest.|Up to 5 years||||||
158761|NCT00301756|Secondary|Overall Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years||||||
158762|NCT00301756|Secondary|Progression-free Survival|Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Duration of time from start of treatment to time of progression, assessed up to 5 years||||||
158763|NCT00301756|Secondary|Duration of Response|Summarized using summary statistics, such as the mean, median, counts and proportion. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years|No participants had an objective response out of the 32 patients analyzed.|||||
158764|NCT00301756|Secondary|Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group)|Stable disease rate, defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive disease, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.|Up to 5 years|14 patients with Low Malignant Potential tumours or Micropapillary / borderline were analyzed||participants|||Number
158765|NCT00301756|Secondary|Time to Disease Progression (Epithelial Ovarian Cancer Group)|Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.|Up to 5 years|Eighteen patients with Epethelial Ovarian Cancer were analyzed||months||95% Confidence Interval|Median
158766|NCT00301756|Primary|Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD|Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.|Up to 5 years|||participants|||Number
158767|NCT00301418|Secondary|Overall Survival (OS)||Duration of the trial|||days||95% Confidence Interval|Median
158768|NCT00301418|Secondary|6-month Progression Free Survival (PFS)||Duration of the trial|||days||95% Confidence Interval|Median
158769|NCT00301418|Primary|Safety of Twice a Day Oral 150 mg Erlotinib Dosing|Greater than or equal to Grade 2 Adverse Event|duration of the trial|||participants|||Number
158770|NCT00301366|Primary|Treatment-emergent Adverse Events (TEAEs) Defined as Any Adverse Event (AE) Occurring During or After the Start of the First Study Drug Infusion.|An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.|24 weeks|38 subjects received study medication and one subject discontinued from the study due to an AE. Therefore, 37 subjects completed the study. 18 subjects were naive ((i.e., never having received previous Alpha-1 protease inhibitor augmentation therapy) and 19 subjects were non-naive.||Participants|||Number
158771|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections|Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158772|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4|Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158773|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4|Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158774|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3|Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158775|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2|Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158776|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1|Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158777|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0|Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158778|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158779|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4|Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158780|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3|Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158781|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2|Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158782|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1|Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <= Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158783|NCT00301262|Secondary|Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0|Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to <Week 8 and Week 8 to <=Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158784|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ3|GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.||subjects|||Number
158785|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for GEQ2|GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.||subjects|||Number
158786|NCT00301262|Secondary|Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1|GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.|Week 8 to Week 14|number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.||subjects|||Number
158787|NCT00301262|Secondary|Analog Scales- General Sexual Performance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
158788|NCT00301262|Secondary|Analog Scales- Reliability|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
158789|NCT00301262|Secondary|Analog Scales- Maintenance|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
158790|NCT00301262|Secondary|Analog Scales- Firmness|mean - scale of 0 (worst) to 10 (best)|Week 8, Week 14|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
158791|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- General Sexual Performance|mean change - scale of 0 (worst) to 10 (best)|baseline to week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
158792|NCT00301262|Secondary|Change From Baseline to Week 8 in Analog Scales- Reliability|mean change - scale of 0 (worst) to 10 (best).|baseline to Week 8|number of subjects in the FAS population with an observation||units on a scale||Standard Deviation|Mean
158795|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)|Percentage of occasions at which subjects answered yes to the question Did you ejaculate and/or have an orgasm? . Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158796|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question Did your erection last long enough to have successful intercourse? . Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Week 8 to Week 14|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158797|NCT00301262|Secondary|Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)|Percentage of occasions at which subjects answered yes to the question Did you ejaculate and/or have an orgasm? . Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation||Percentage of occasions||Standard Deviation|Mean
158798|NCT00301262|Secondary|Percentage of Occasions of Successful Intercourse (Event Log)|Percentage of occasions at which subjects answered yes to the question Did your erection last long enough to have successful intercourse? . Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of ‘Yes’ within visit interval) / (number of occasions within visit interval) x 100.|Baseline to Week 8|number of subjects in the FAS population with an observation||percentage of occasions||Standard Deviation|Mean
158799|NCT00301262|Secondary|Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.|Week 8, Week 14|number of subjects in the FAS population with an observation||percentage of subjects|||Number
158800|NCT00301262|Secondary|Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.|Week 8, Week 14|number of subjects in the FAS population with an observation||percentage of subjects|||Number
158801|NCT00301262|Secondary|Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)|GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering “Yes”. % of responders/non-responders was calculated based on subjects who attempted intercourse.|Week 8, Week 14|number of subjects in the FAS population with an observation||percentage of subjects|||Number
158802|NCT00301262|Secondary|Quality of Erection Questionnaire (QEQ) Total Score|QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8, Week 14|Full Analysis Set||scores on a scale||Standard Deviation|Mean
158803|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score|adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158804|NCT00301262|Secondary|Erectile Distress Scale (EDS) Total Score|Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158805|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score|adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158806|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158807|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158808|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158809|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158810|NCT00301262|Secondary|International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158811|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction|adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158812|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction|adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158813|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire|adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158814|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function|adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158815|NCT00301262|Secondary|Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function|adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158816|NCT00301262|Secondary|Patient Reported Erectile Function Assessment (PREFA) Total Score|PREFA Total Score: 8 = worst, 32 = best.|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158817|NCT00301262|Secondary|Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score|adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.|Week 8|number of subjects in the FAS population with an observation||scores on a scale||Standard Error|Least Squares Mean
158818|NCT00301262|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index|Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8, Week 14|number of subjects in the FAS population with an observation||scores on a scale||Standard Deviation|Mean
158819|NCT00301262|Primary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)|adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).|Week 8|number of subjects in the Full Analysis Set (FAS) population with an observation||scores on a scale||Standard Error|Least Squares Mean
158820|NCT00301080|Secondary|Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment|Record the amount of opioid medication used by patients in each arm before and after the study treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
158821|NCT00301080|Secondary|Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane|Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
158822|NCT00301080|Secondary|Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
158823|NCT00301080|Secondary|Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period|Compare individual patients' self-reported pain relief scores before and after the treatment period.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
158824|NCT00301080|Primary|Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory|Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.|From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)|No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.|||||
158825|NCT00301028|Primary|Number of Participants With Complete Response|Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.|Study period of 3 Years|||participants|||Number
158826|NCT00300885|Secondary|Patient Reported Outcome as Assessed by LCS Subscale Score. Change From Baseline in LCS Subscale at Cycles 2 Through 9 and at End of Treatment (EOT)|Lung Cancer Symptoms (LCS) subscale ranges from 0 (severe debilitation) to 28 (asymptomatic). Cycle duration defined as 21 days. Change from baseline in LCS Subscale on day 1 of cycles 2 through 9 (weeks 4,7,10,13,16,19,22 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation.|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every cycle (i.e. Cycle 2, 3, 4, 5 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of LCS Subscale based on the ITT population.||Scores on a scale||Standard Deviation|Mean
158836|NCT00300677|Primary|Brain Concentrations of N-oxide Metabolite|Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
158827|NCT00300885|Secondary|Patient Reported Outcome as Assessed by FACT-L Score. Change From Baseline in Total FACT-L at Cycles 3,5,7,9 and End of Treatment (EOT)|"Functional Assessment of Cancer Therapy - Lung cancer subscore (FACT-L). Patient reported outcome as assessed by FACT-L score. FACT-L questionnaire comprises statements about physical, social / family, emotional and functional well-being as well as additional concerns which have to be rated by the patients (0=not at all to 4=very much). Cycle duration defined as 21 days. Change from baseline in Total FACT-L on day 1 of cycles 3,5,7,9 (weeks 7,13,19 and 25) and end of treatment (EOT); cycle 1, day 1 used as baseline. EOT is determined by patient's last visit after treatment discontinuation."|Outcome measure was assessed on Day 1 of Cycle 1 and Day 1 of every other cycle (i.e. Cycle 3, 5, 7 etc.) during treatment and at end of treatment visit or up to data cutoff (10ct2007) used for planned formal interim analysis|Evaluations of Total FACT-L based on the ITT population.||Scores on a scale||Standard Deviation|Mean
158828|NCT00300885|Secondary|Duration of Response|Duration of response (PR or better) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of duration of response based on the ITT population.||days||95% Confidence Interval|Median
158829|NCT00300885|Secondary|Overall Best Response|Best overall tumor response for the ITT population was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased).|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of overall best response rate based on the ITT population.||percentage of participants|||Number
158830|NCT00300885|Secondary|Progression Free Survival (PFS)|PFS determined as time (days) from the date of randomization at start of study to disease progression (radiological or clinical) or death due to any cause, if death occurs before progression.|Tumor measurements and assessments based on RECIST criteria were performed every 6 weeks for the first 18 weeks of therapy ( week 6, 12, and 18) and every 12 weeks thereafter up to data cutoff (1Oct2007) used for planned formal interim analysis|PFS (based on the ITT population) for subjects without disease progression/death at the time of analysis were censored at the last evaluation date. PFS for surviving subjects without post-baseline tumor assessments were censored at one day. In the case of an incomplete date (missing day), day 15 (the middle of the month) will be used.||days||95% Confidence Interval|Median
158831|NCT00300885|Primary|Overall Survival (OS) in Patients Treated With Carboplatin, Paclitaxel and Sorafenib to OS in Patients Treated With Carboplatin, Paclitaxel and Placebo|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks during study treatment and every 3 months during post-treatment.|Outcome measure was assessed every 3 weeks starting from randomization, during treatment period and every 3 months during follow-up period until death was recorded or up to data cutoff (1Oct2007) used for planned formal interim analysis|Evaluations of OS based on the ITT population. Subjects alive at the time of analysis were censored at their last date of follow-up (last visit or contact or at the data cut-off date). In the case of an incomplete date, if the day is missing, day 15 (the middle of the month) will be used.||days||95% Confidence Interval|Median
158832|NCT00300755|Secondary|"Number of Patients With Healed Erosive Esophagitis (EE) at End of Study"|Healed EE was defined as a modified Hetzel-Dent (HD) score <2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).|8 weeks|The analysis population is randomized patients with erosive esophagitis at baseline.||patients|||Number
158833|NCT00300755|Secondary|Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline|Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Data were excluded if a patient answered a question <3 times in a week.||units on scale||Standard Deviation|Mean
158834|NCT00300755|Secondary|Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week|Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.|Baseline and 8 weeks|The analysis population is all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease.||units on scale||Standard Deviation|Mean
158835|NCT00300755|Primary|Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)|WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.|Baseline and 8 weeks|The primary efficacy population (mITT NERD) included all patients who were randomized and received ≥1 dose of test article and had nonerosive gastroesophageal reflux disease. Last observation carried forward (except for baseline data, which were not carried forward into the treatment period).||units on scale||Standard Deviation|Mean
158884|NCT00300235|Secondary|Descriptive Comparison of the Prevalence of Priapism in Males With Sickle Cell Anemia to That Described in Older Patients With Other Sickle Hemoglobinopathies|Descriptive comparison of the prevalence of priapism in males with sickle cell anemia to that described in older patients with other sickle hemoglobinopathies.|Cross-sectional single survey visit||||||
158837|NCT00300677|Primary|Plasma Concentrations of N-oxide Metabolite|Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
158838|NCT00300677|Primary|Brain Concentrations of Voriconazole|Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
158839|NCT00300677|Primary|Plasma Concentrations of Voriconazole|Mean plasma voriconazole concentrations (nanograms per milliliter [ng/mL]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.|Day 3: pre-dose, 2 hours post-dose|Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).||ng/mL||Standard Deviation|Mean
158840|NCT00300482|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF||percent change||Inter-Quartile Range|Median
158841|NCT00300482|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline ApoB and at least 1 postbaseline ApoB value, LOCF||percent change||Standard Error|Mean
158842|NCT00300482|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF||percent change||Standard Error|Mean
158843|NCT00300482|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF||percent change||Standard Error|Mean
158844|NCT00300482|Secondary|Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF||percent change||Standard Error|Mean
158845|NCT00300482|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward||percent change||Standard Error|Mean
158846|NCT00300482|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward||percent change||Standard Error|Mean
158847|NCT00300482|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward||percent change||Standard Error|Mean
158848|NCT00300469|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF||percent change||Inter-Quartile Range|Median
158849|NCT00300469|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF||percent change||Standard Error|Mean
158850|NCT00300469|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF||percent change||Standard Error|Mean
158851|NCT00300469|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF||percent change||Standard Error|Mean
158852|NCT00300469|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF||percent change||Standard Error|Mean
158853|NCT00300469|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)||percent change||Standard Error|Mean
158854|NCT00300469|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbasline HDL-C value, last observation carried forward (excluding 1 subject with extreme outlying value)||percent change||Standard Error|Mean
159299|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
158855|NCT00300469|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward (excluding one subject with an extreme outlying value)||percent change||Standard Error|Mean
158856|NCT00300456|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit|[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF||percent change||Inter-Quartile Range|Median
158857|NCT00300456|Secondary|Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit|[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline ApoB value and at least 1 postbaseline ApoB value, LOCF||percent change||Standard Error|Mean
158858|NCT00300456|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Final Visit|[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF||percent change||Standard Error|Mean
158859|NCT00300456|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit|[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF||percent change||Standard Error|Mean
158860|NCT00300456|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit|[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF||percent change||Standard Error|Mean
158861|NCT00300456|Primary|Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit|[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward||percent change||Standard Error|Mean
158862|NCT00300456|Primary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit|[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward||percent change||Standard Error|Mean
158863|NCT00300456|Primary|Mean Percent Change in Triglycerides From Baseline to Final Visit|[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100|Baseline to 12 Weeks (Final Visit)|All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward||percent change||Standard Error|Mean
158864|NCT00300430|Secondary|Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Full Range|Median
158865|NCT00300430|Primary|Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study||Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies or in this open-label study. All adverse events in the preceding studies or in this study occurring with exposure to combination therapy are summarized.||percentage of participants|||Number
158866|NCT00300430|Secondary|Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
158867|NCT00300430|Secondary|Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
158868|NCT00300430|Secondary|Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
158869|NCT00300430|Secondary|Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study||Baseline to Week 52 in this open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
158870|NCT00300430|Secondary|Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
158871|NCT00300430|Secondary|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Standard Deviation|Mean
158872|NCT00300430|Secondary|Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study||Baseline to Week 52 of the open-label study|Subjects who took at least 1 dose of ABT-335 plus a statin in the preceding double-blind studies. Baseline is the last value before the first dose of combination therapy in the preceding studies. Percent changes from baseline to Week 52 in this open-label study are summarized. No imputations were made for missing values.||percent change||Full Range|Median
158873|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
158874|NCT00300274|Secondary|Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R~C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|24 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.||mL/min/1.73^2||Standard Deviation|Mean
158875|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window).|24 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
158876|NCT00300274|Secondary|Percentage of Participants With Composite Efficacy Failure at 24 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.~Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment."|24 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
158877|NCT00300274|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12|"Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment."|12 Months|Intent-to-treat population includes all randomized participants.||Percentage of participants|||Number
158878|NCT00300274|Secondary|Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12|Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12.|12 Months|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers).||Percentage of participants|||Number
158879|NCT00300274|Secondary|Change From Baseline in the Average Maximum Intimal Thickness at Month 12|Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery.|Baseline, Month 12|IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers).||mm||Standard Deviation|Mean
158880|NCT00300274|Secondary|Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months|"GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where C is the serum concentration of creatinine [mg/dL] A is age [years] G=0.742 when gender is female, otherwise G=1 R=1.21 when race is black, otherwise R=1"|12 Months|Participants from the intent-to-treat population (all randomized participants) with data available for analysis.||mL/min/1.73^2||Standard Deviation|Mean
158881|NCT00300274|Secondary|Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months|Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window).|12 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
158882|NCT00300274|Primary|Percentage of Participants With Composite Efficacy Failure at 12 Months|"Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up.~Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides.~Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment."|12 Months|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
158883|NCT00300235|Secondary|Assessment of General Patient and Parent Understanding of Priapism as a Complication of Sickle Cell Disease Gained From Completion of Protocol|Assessment of general patient and parent understanding of priapism as a complication of sickle cell disease gained from completion of protocol.|Cross-sectional single survey visit||||||
158885|NCT00300235|Secondary|Characterization of Priapism in Males With Sickle Cell Anemia With Reference to Time of Onset, Duration of Events, Frequency of Episodes, Precipitating or Associated Activities, Treatment Modalities Used, and Outcome of Treatments|Characterization of priapism in males with sickle cell anemia with reference to time of onset, duration of events, frequency of episodes, precipitating or associated activities, treatment modalities used, and outcome of treatments.|Cross-sectional single survey visit||||||
158886|NCT00300235|Primary|Enumeration of the Prevalence of Priapism in Males With Sickle Cell Anemia and Sickle Beta Zero Thalassemia.|"Subject responded YES to survey Question Have you ever had priapism?. By diagnosis and age group. Enumeration of the prevalence of priapism in males with sickle cell anemia and sickle beta zero thalassemia."|At time of interview|All particpants who completed survey were analyzed.||participants|||Number
158887|NCT00299975|Secondary|Serum Glutamic Oxaloacetic Transaminase(SGOT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
158888|NCT00299975|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||U/L||Standard Deviation|Mean
158889|NCT00299975|Secondary|Blood Creatinine Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||μmol/L||Standard Deviation|Mean
158890|NCT00299975|Secondary|Blood Urea Level||Pre-treatment(Week2) & Post-treatment(Week10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||mmol/L||Standard Deviation|Mean
158891|NCT00299975|Secondary|Adverse Effects (e.g. Renal and Liver Function Tests)||pre-treatment & post-treatment||||||
158892|NCT00299975|Secondary|Passing of Gas|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
158893|NCT00299975|Secondary|Sensation of Abdominal Pain/Cramping|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
158894|NCT00299975|Secondary|Sensation of Bloating|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
158895|NCT00299975|Secondary|Incomplete of Evacuation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
158896|NCT00299975|Secondary|Sensation of Straining|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
158897|NCT00299975|Secondary|Severity of Constipation|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Week2), Within treatment(Week6), End of treatment(Week10) & End of follow-up(Week18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||Units on a scale||Standard Deviation|Mean
158898|NCT00299975|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Week6, 10 & 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
158899|NCT00299975|Secondary|Complete Spontaneous Bowel Movement (CSBM)|CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
158900|NCT00299975|Secondary|Bowel Movement||Baseline(Week1-2), Within treatment(Week3-10) & Within follow-up(Week11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||movements per week||Standard Deviation|Mean
158901|NCT00299975|Secondary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week11-18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
158902|NCT00299975|Primary|Responder for Complete Spontaneous Bowel Movement (CSBM)|Participants with a mean increase of CSBM>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|Week3-10|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.||participants|||Number
158903|NCT00299741|Secondary|Objective Responses, Defined as the Number of Participants With Complete or Partial Response|The response rate is defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by radiographic evaluation. Complete response(CR): disappearance of all target lesions; Partial response(PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall response = CR + PR.|Participants were followed until the time of disease progression, an average of 12 weeks|||participants|||Number
158904|NCT00299741|Primary|The Number of Men With Advanced Prostate Cancer Treated With Sunitinib Who Have a Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) responses, defined as the number of men who exhibit PSA decline of at least 50% that is confirmed by a second PSA value 4 or more weeks later (PSA Working Group I Criteria)|were followed until disease progression, an average of 12 weeks|All participants analyzed||participants|||Number
158905|NCT00299702|Primary|Time in Remission|Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).|Day 1 to last PANSS measurement|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.||days||Standard Deviation|Mean
158906|NCT00299702|Primary|Time to Relapse|Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.|Day 1 to relapse|explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.||days||95% Confidence Interval|Median
158907|NCT00299689|Secondary|Overall Survival||All cause mortality||||||
158908|NCT00299689|Primary|Positive Response Defined as Clinical Complete Response, Partial Response or Stable Disease (Persisting for at Least 4 Weeks) as Measure by Modified RECIST Criteria||2 weeks after completion of second cycle|||participants|||Number
158909|NCT00299546|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 24|Improvement from baseline in HAQ score at Week 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.|From Baseline to Week 24|Randomized participants (excluding 1 site). Missing scores imputed by Last Observation Carried Forward. Week 16 scores were used for participants with change in study treatment.||scores on a scale||Inter-Quartile Range|Median
158910|NCT00299546|Secondary|American College of Rheumatology (ACR) 20 at Week 24|Number of patients who achieved ACR 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale,HAQ and CRP)|From Baseline to Week 24|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components imputed by LOCF unless all components were missing; in which case considered non-responders. Wk 16 ACR response used for change in study tx.||participants|||Number
158911|NCT00299546|Secondary|Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14|DAS 28 using C-reactive protein (CRP) is an index to measure disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant’s global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing DAS 28 components imputed by Last Observation Carried Forward unless all components were missing; in which case considered non-responders.||participants|||Number
158912|NCT00299546|Secondary|American College of Rheumatology (ACR) 50 Response at Week 14|Number of patients who achieved an ACR 50 response at Week (Wk) 14. ACR 50 response is an improvement of >= 50% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessemnt of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||participants|||Number
158913|NCT00299546|Primary|American College of Rheumatology (ACR) 20 Response at Week 14.|ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)|Week 14|Randomized participants (excluding 1 site). Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||participants|||Number
158914|NCT00299416|Primary|Number of Participants With Cardiorespiratory Failure|The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.|every 30 minutes during hypothermia induction|||participants|||Number
158915|NCT00299416|Primary|Number of Participants With Catheter Related Complications During Hypothermia & Rewarming|Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.|over 36 hour period|||participants|||Number
158916|NCT00299416|Secondary|Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay.|NIHSS score of ≤ 2 24 hours after stroke onset modified Rankin Scale (mRS) < 2 at 90 day followup NIHSS score of ≤ 2 at daily duration of hospitalization and ICU stay and 90 day follow up.|90 days||||||
158917|NCT00299416|Secondary|Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.||rewarming over 12 hours until 36.5C has been achieved||||||
158918|NCT00299416|Secondary|Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,|Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.|rewarming over 12 hours until 36.5C has been achieved||||||
158919|NCT00299416|Primary|Number of Participants With Symptomatic Intracerebral Hemorrhage|Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol & hypothermia,at the end of hypothermia & rewarming, 24 hrs after stroke onset, daily during hospitalization,& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period & 12 hr rewarming period. At the end of rewarming an MRI was obtained to verify if hemorrhages or neurologic deteriorations were present.NIHSS scores severity of stroke on 11 items;more points given for greater deficiencies(range 0-42,0=normal)|from pre-dosage to 90 day followup|Number of participants were determined by intention to treat. We did not use any imputation technique.||participants|||Number
158920|NCT00299221|Secondary|Mean ISHLT Biopsy Score Over First Year Post-transplant|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|1 year|all pts, Intention to treat||units on a scale||Standard Deviation|Mean
158921|NCT00299221|Secondary|Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant|Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant|1 year|Percent of patients with allograft CAD at one year post-transplant||patients|||Number
158922|NCT00299221|Secondary|Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant|Number of patients developing cytomegalovirus disease by 1 year post-transplant|1 year|all patients||participants|||Number
158923|NCT00299221|Secondary|Percent of Patients Alive at One Year Post-transplant|Percent of patients alive at one year post-transplant. In other words, all cause mortality over time|1 year|all pts, intention to treat||percent of participants|||Number
158924|NCT00299221|Primary|Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation|Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.|6 months|all pts, intention to treat||units on a scale||Standard Deviation|Mean
158925|NCT00299156|Primary|Participants With a Complete Remission (CR)|"Complete Remission (CR): Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L).~Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment.~Hematologic Improvement: meets all criteria for CR except for platelet recovery to >100 x 109/L.~Clinical Benefit: Platelets increase by 50% and to above 30 x 109/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 109/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 109/L."|After 3 courses of treatment, up to 24 weeks.|||Participants|||Number
158926|NCT00299130|Post-Hoc|Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment|A low immunoglobulin concentration was defined as a concentration below the lower level of normal.|Baseline (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab)|"Safety follow-up population: All participants who were randomized and received any part of a rituximab infusion. Number of participants analyzed = participants with available data. N indicates the number of participants with non-missing data at each time point."||Percentage of participants|||Number
158927|NCT00299130|Post-Hoc|Time to Repletion of Peripheral CD19+ B-cells|Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower.|Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years)|Extended safety follow-up population: All participants who were randomized, received any part of a rituximab infusion, and entered the extended safety follow-up period.||Weeks||95% Confidence Interval|Median
158943|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158928|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 48|"To achieve an ACR70 required at least a 70% improvement compared with baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
158929|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 48|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 48|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
158930|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 48|Intent to treat population including participants with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.||percentage of participants|||Number
158931|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher."|Baseline and Week 48|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Patients who withdrew prior to week 48, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.||percentage of participants|||Number
158932|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 48|Intent-to-treat population including participants with available data. LOCF was used.||percentage of participants|||Number
158933|NCT00299130|Secondary|Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.~Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.~An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.~A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22."|Baseline and Week 24|Intent-to-treat population including participants with available data. LOCF was used.||percentage of participants|||Number
159015|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
158934|NCT00299130|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.~Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6."|Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing. Number of participants analyzed = participants who were evaluable for this outcome.||percentage of participants|||Number
158935|NCT00299130|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores|"The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158936|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158937|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158938|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158939|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158940|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158941|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
158942|NCT00299130|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.~A positive change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population. N indicates the number of participants with non-missing data at each time point."||scores on a scale||Standard Deviation|Mean
159016|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 168|Serologically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
158944|NCT00299130|Secondary|Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)|"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A positive percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158945|NCT00299130|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate|"Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158946|NCT00299130|Secondary|Percent Change From Baseline in C-Reactive Protein|"C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158947|NCT00299130|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158948|NCT00299130|Secondary|Percent Change From Baseline in Physician’s Global Assessment of Disease Activity|"The physician’s assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158949|NCT00299130|Secondary|Percent Change From Baseline in Patient’s Pain Assessment|"The participant’s assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as no pain and the right-hand extreme (100 mm) as unbearable pain.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158950|NCT00299130|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity|"The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity).~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158951|NCT00299130|Secondary|Percent Change From Baseline in Tender Joint Count|"Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
158952|NCT00299130|Secondary|Percent Change From Baseline in Swollen Joint Count|"Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.~The percentage change from baseline at each post-baseline visit was calculated as:~[(post-baseline value minus baseline value) divided by Baseline value]*100.~A negative percentage change from baseline score indicates an improvement."|Baseline, Week 24 and Week 48|"Intent-to-treat population, LOCF was used. N indicates the number of participants with non-missing data at each time point."||percent change||Standard Deviation|Mean
159034|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 96|Biochemically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
158953|NCT00299130|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1."|Baseline and Week 24|Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Participants who withdrew prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.||percentage of participants|||Number
158954|NCT00299130|Secondary|Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24|"The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity measured on a 100 mm visual analog scale.~The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6."|Baseline and Week 24|Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.||scores on a scale||Standard Deviation|Mean
158955|NCT00299130|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
158956|NCT00299130|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
158957|NCT00299130|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24|"To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:~Physician's global assessment of disease activity (assessed using a 100 mm Visual Analog Scale [VAS]);~Patient's global assessment of disease activity (assessed using a 100 mm VAS);~Patient's assessment of pain (assessed using a 100 mm VAS);~Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3);~Acute phase reactant: C-reactive protein (CRP) or, if CRP was missing, erythrocyte sedimentation rate (ESR).~Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders."|Baseline and Week 24|Intent to treat population included all randomized participants who received at least 1 or part of an infusion. ACR was calculated using the last observation carried forward (LOCF) values for each component. Participants who withdrew prior to week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders.||percentage of participants|||Number
158958|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 104|Participants from the Intent-to treat Population includes all randomized participants who received at least one dose of study drug with data at baseline and Week 104 available for analysis. Last observation carried forward.||Score on a scale||Standard Deviation|Mean
159300|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
158959|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104|"Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The score at baseline is compared to the score at week 104.~No progression is defined as a change from score at screening to week 104 ≤0."|Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing.||Percentage of Participants|||Number
158960|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 104|Percentage of patients without radiographic progression at Week 104, defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 104|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing||Percentage of Participants|||Number
158961|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 104|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The change from the score at baseline to week 104 is calculated.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and who had both screening and post-baseline radiographic assessments at the given time point for analyses. Linear extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
158962|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 104|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 104|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time-point for analysis. Linear extrapolation was used for missing data.||Score on a scale||Standard Deviation|Mean
158963|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Mental Health Component Score of >6.33.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.||Percentage of Participants|||Number
158964|NCT00299104|Secondary|Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52|"MCID is defined as a change from baseline in SF-36 Physical Health Component Score of >5.42.~SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Baseline, Week 52|Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.||Percentage of Participants|||Number
158965|NCT00299104|Secondary|Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52|"The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction.~Improved:HAQ-DI score change <=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score => 0.22"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward.||Percentage of participants|||Number
158966|NCT00299104|Secondary|Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Weeks 52, Week 104|"Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."||Score on a scale||Standard Deviation|Mean
159075|NCT00297778|Secondary|Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12|The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data.||units on a scale||Inter-Quartile Range|Median
158967|NCT00299104|Secondary|Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104|"The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.~Means are adjusted for baseline value, Rheumatoid Factor status and region."|Baseline, Week 52, Week 104|"Intent to treat (ITT) population includes all participants who received at least one infusion. Last observation carried forward. n in each of the categories is the number of participants with data available for analyses at the given time point."||Score on a scale||Standard Deviation|Mean
158968|NCT00299104|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 52|Intent-to treat Population includes all randomized participants who received at least one dose of study drug. Last observation carried forward.||Score on a scale||Standard Deviation|Mean
158969|NCT00299104|Secondary|Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Observed data.||Score on a scale||Standard Deviation|Mean
158970|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52|"To achieve an ACR90 response requires at least a 90% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 90% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
158971|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52|"To achieve an ACR20 response requires at least a 20% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 20% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
158972|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses.||Percentage of Participants|||Number
158973|NCT00299104|Secondary|The Percentage of Participants With Major Clinical Response at Week 52|"Major clinical response is defined as a continuous six-month period of success by the ACR70.~ACR70= 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in 3 of five additional measurements from:~the physician’s global assessment of disease activity~patient’s global assessment of disease activity~patient’s assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion.||Percentage of Participants|||Number
158974|NCT00299104|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52|European League Against Rheumatism (EULAR) criteria reflects an improvement in disease activity and an attainment of a lower degree of disease activity. A good response is defined as an improvement in the DAS28-ESR of > 1.2 compared with baseline, and attainment of a DAS28-ESR of < 3.2.|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing||Percentage of Participants|||Number
158975|NCT00299104|Secondary|Percentage of Participants With DAS28-ESR Remission at Week 52|"The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.~Remission is defined as achieving a DAS28-ESR score of less than 2.6"|Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion with data available for analyses.||Percentage of Participants|||Number
158976|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52|"To achieve an ACR70 response requires at least a 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in three of five additional measurements from:~the physician's global assessment of disease activity~patient's global assessment of disease activity~patient's assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Baseline, Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
158977|NCT00299104|Secondary|Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52|"DAS28-ESR is calculated from the following formula:~(0.56 * TJC) + (0.28 * SJC) + (0.70 * ln ESR) + (0.014 * GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient’s global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR < 2.6)."|Baseline, Week 52|Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Last observation carried forward.||Score on a scale||Standard Deviation|Mean
158978|NCT00299104|Secondary|Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52|"To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:~the physician’s global assessment of disease activity~patient’s global assessment of disease activity~patient’s assessment of pain~HAQ-DI (Health Assessment Questionnaire disability index)~an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"|Week 52|Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).||Percentage of Participants|||Number
158979|NCT00299104|Secondary|Percentage of Participants Without Radiographic Progression at Week 24|Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 24|Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing||Percentage of Participants|||Number
158980|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24|Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) with data available at Week 24 for analysis.||Score on a scale||Standard Deviation|Mean
158981|NCT00299104|Secondary|Change From Baseline in the Total Erosion Score at Week 24|Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated.|Baseline, Week 24|Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) who had data available at Week 24 for analysis.||Score on a scale||Standard Deviation|Mean
158982|NCT00299104|Secondary|Change From Baseline in the Modified Total Sharp Score at Week 24|The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline, Week 24|Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time point for analysis.||Score on a scale||Standard Deviation|Mean
158983|NCT00299104|Secondary|Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
158984|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52|No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Percentage of Participants|||Number
159017|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 144|Serologically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
158985|NCT00299104|Secondary|Percentage of Patients Without Radiographic Progression at Week 52|Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) <= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.|Baseline, Week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.||Percentage|||Number
158986|NCT00299104|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52|Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
158987|NCT00299104|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52|Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.|Baseline and week 52|Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.||Score on a scale||Standard Deviation|Mean
158988|NCT00299000|Primary|Change in Haed Circumference||52 weeks|||centimeter||Standard Deviation|Mean
158989|NCT00299000|Primary|Change in Weight||52 weeks|||kilograms||Standard Deviation|Mean
158990|NCT00299000|Primary|Change in Height||52 weeks|Intention to treat.||centimeters||Standard Deviation|Mean
158991|NCT00299000|Secondary|Change in Urinary Glycosaminoglycan Levels|Change in urinary GAG levels was calculated from baseline to week 52 of treatment.|minimum 52 weeks of dosing|Intention to treat.||ug/mg creatinine||Standard Deviation|Mean
158992|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination|Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
158993|NCT00298766|Primary|Subjects Grade 3/4/5 Treatment Emergent Adverse Events|"Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame.~Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0."|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
158994|NCT00298766|Primary|Subjects With Serious Treatment Emergent Adverse Events|Serious treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
158995|NCT00298766|Secondary|Best Confirmed Hematologic Responders|Hematologic response was determined by the investigator per the response criteria for immunoglobulin light chain amyloidosis by Gertz (2005). It include Complete and Partial Responders (CR+PR). CR requires serum and urine negative for a monoclonal protein by immunofixation and free light chain ratio normal. PR requires: 1. reduction in quantitative serum M-protein by 50% if baseline value is at least 0.5 g/dL, 2. if light chain is detected in the urine (with a consistent peak and >100 mg/ 24 hours), then 50% reduction is required, 3. if free light chain >10 mg/dL, reduction by 50% is required.|from first dose of study medication to end of study visit|Efficacy population included all treated subjects with an evaluable post baseline resposne assessment in the MTD cohorts (1.6 mg/m^2 QW and 1.3 mg/m^2 BIW).||participants responded|||Number
158996|NCT00298766|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame|from first study-related procedure to 30 days after last dose of study medication|Safety population||participants|||Number
158997|NCT00298766|Primary|Maximum Tolerated Dose|"Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts.~DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity."|5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts|Phase 1 Safety Population includes all subjects who received at least one dose of VELCADE in phase 1 dose escalation cohorts||participants with DLT|||Number
158998|NCT00298558|Primary|Changes in Everyday Speed of Processing From Baseline to Year 10|"Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the everyday speed of processing outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
158999|NCT00298558|Primary|Changes in Everyday Problem Solving From Baseline to Year 10|"Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1104 subjects who had the everyday problem solving outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
159033|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 144|Biochemically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
159000|NCT00298558|Primary|Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10|"The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 1211 subjects who had the IADL outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
159001|NCT00298558|Primary|Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10|"Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 879 subjects who had the speed outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
159002|NCT00298558|Secondary|Estimate the Effects of ACTIVE Training to General Population|To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.|10th Year||||||
159003|NCT00298558|Primary|Changes in Cognitive Abilities of Reasoning From Baseline to Year 10|"Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 938 subjects who had the reasoning outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
159004|NCT00298558|Secondary|Examine Health, Genetic and Cognitive Moderators|To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.|10th Year||||||
159005|NCT00298558|Secondary|Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use|To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.|10th Year||||||
159006|NCT00298558|Primary|Changes in Cognitive Abilities of Memory From Baseline to Year 10|"Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as 10 year minus baseline and the negative values indicate the decline from baseline."|Up to 10 years|Of the randomized subjects, 943 subjects who had the memory outcome at year 10 were used.||units on a scale||Standard Deviation|Mean
159007|NCT00298363|Secondary|In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results||Baseline to Week 168|Liver transplantation analysis set||Days|||Number
159008|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159009|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159010|NCT00298363|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96|Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159011|NCT00298363|Primary|Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL|Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation.|Baseline to Week 168|Full analysis set||percent probability (KM estimate)||95% Confidence Interval|Number
159012|NCT00298363|Other Pre-specified|Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with both ADV and LAM resistance mutations at baseline were included in this analysis.||percentage of participants|||Number
159013|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation.|Baseline to Week 168|Patients in the full analysis set with LAM resistance mutation at baseline were included in this analysis.||percentage of participants|||Number
159014|NCT00298363|Other Pre-specified|Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks|ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation.|Baseline to Week 168|Participants in the full analysis set with ADV resistance mutation at baseline were included in this analysis.||percentage of participants|||Number
159018|NCT00298363|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 96|Serologically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
159019|NCT00298363|Secondary|Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)|Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline to Week 48|Serologically evaluable analysis set (subjects in full analysis set with positive hepatitis B early antigen [HBeAg] at baseline); noncompleters/switch = failure||percentage of participants|||Number
159020|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 168|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 168|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
159021|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 144|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 144|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
159022|NCT00298363|Secondary|Median Change in MELD Score From Baseline at Week 96|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 96|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
159023|NCT00298363|Secondary|Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48|MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline to Week 48|Subjects in the full analysis set with an available score at the visit||units on a scale||Inter-Quartile Range|Median
159024|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|CPT evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
159025|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|CPT evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
159026|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|CPT evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
159027|NCT00298363|Secondary|Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|CPT evaluable analysis set (subjects with CPT scores ≥ 7 at baseline; because the minimum CPT score was 5, only these subjects were evaluable for analyses of ≥ 2-point decrease in CPT score); noncompleters/switch = failure||percentage of participants|||Number
159028|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 168|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159029|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 144|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159030|NCT00298363|Secondary|Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 96|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159031|NCT00298363|Secondary|Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48|CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline to Week 48|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159032|NCT00298363|Secondary|Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168|Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 168|Biochemically evaluable analysis set; noncompleters/switch = failure||percentage of participants|||Number
159035|NCT00298363|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48|Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|Baseline to Week 48|Biochemically evaluable analysis set (subjects in full analysis set with abnormal baseline alanine aminotransferase [ALT] values); noncompleters/switch = failure||percentage of participants|||Number
159036|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized.|Week 168|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159037|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized.|Week 144|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159038|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized.|Week 96|Full analysis set; noncompleters/switch = failure||percentage of participants|||Number
159039|NCT00298363|Secondary|Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48|The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized.|Week 48|Full analysis set; noncompleters/switch = failure analysis (participants who did not complete treatment or changed from double-blind to open-label treatment up to the time point were considered as failing to meet efficacy response criteria [defined as not achieving viral suppression of < 400 copies/mL]).||percentage of participants|||Number
159040|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 168 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 168 were excluded.||log_10 copies/mL||Inter-Quartile Range|Median
159041|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 144 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 144 were excluded.||log _10 copies/mL||Inter-Quartile Range|Median
159042|NCT00298363|Secondary|Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 96 weeks|Full analysis set; data collected for participants who underwent liver transplant prior to Week 96 were excluded.||log_10 copies/mL||Inter-Quartile Range|Median
159043|NCT00298363|Secondary|Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline|Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value.|Baseline to 48 weeks|Participants with HBV DNA measurements at Week 48 were included in this analysis.||log_10 copies/mL||Inter-Quartile Range|Median
159044|NCT00298363|Primary|Percent Probability of Tolerability Failure|Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation.|Baseline to Week 168|Full analysis set (all randomized subjects who received at least one dose of study drug)||percent probability (KM estimate)||95% Confidence Interval|Number
159045|NCT00298272|Primary|Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings|The following immunological assessments were conducted: autoantibody concentrations for RF, anti-cyclic-citrullinated peptide (CCP) antibody concentrations, quantitative immunoglobulin levels, and lymphocyte assessments of T- and B-cell populations, determined using whole blood expanded fluorescent-activated cell sorter (FACS) analysis. The following laboratory assessments were performed: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC) with differential, and platelet counts; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, total bilirubin, blood urea nitrogen (BUN), uric acid, creatinine, random glucose, potassium, sodium, chloride, calcium, and phosphorous; blood, protein, and glucose (microscopic examination, if abnormal and applicable).|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||participants|||Number
159046|NCT00298272|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24|An AE was any sign (including an abnormal laboratory result that the investigator determined to be clinically significant), symptom, or diagnosis/disease that is unfavorable or unintended, that was new, or if pre-existing, worsened in a participant and that did not necessarily have a causal relationship with the treatment. An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||participants|||Number
159047|NCT00298272|Primary|Maximum Duration of Infections Through Week 24|Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). For participants with multiple infections, only the infection with the longest duration was included in this analysis.|Week 24|Participants in the Safety Population with at least 1 infection. The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||days||Standard Deviation|Mean
159048|NCT00298272|Primary|Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24|Infections were defined as adverse events that map to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) of “infections and infestations” and also included other infectious events that do not map to this SOC (e.g., cholecystitis, pleurisy, conjunctivitis, acne, tongue ulceration). Participants with multiple infections were calculated only once. The severity of all reported adverse events, including infections, was graded and reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events. This scale defines the severity of an adverse event as follows: Grade 1 = a mild adverse event, Grade 2 = a moderate adverse event, Grade 3 = a severe adverse event, and Grade 4 = a life-threatening or disabling adverse event.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||participants|||Number
159049|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 70 (ACR70) Response at Week 24|An ACR70 response is defined as a 70% reduction in the number of both swollen and tender joints, and a 70% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.||proportion of participants|||Number
159050|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 50 (ACR50) Response at Week 24|An ACR50 response is defined as a 50% reduction in the number of both swollen and tender joints, and a 50% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.||proportion of participants|||Number
159051|NCT00298272|Secondary|Proportion of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 24|An ACR20 response is defined as a 20% reduction in the number of both swollen and tender joints, and a 20% reduction in the score or results of at least 3 of the following 5 core set measurement tools: Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo. Missing data were imputed using the nonresponder method, in which a participant with missing data at the visit being analyzed was considered a nonresponder.||proportion of participants|||Number
159052|NCT00298272|Primary|Proportion of Participants With at Least One Serious Infection Through Week 24|An infection was considered serious if it required intravenous (IV) antibiotics or met the regulatory definition of a serious adverse event (SAE). An SAE was any event that resulted in death, resulted in a congenital anomaly in a child of a participant in the study, caused or prolonged an inpatient hospitalization, resulted in significant or persistent disability, or was considered by the investigator to be an important medical event that may have required intervention to prevent any of the above-listed outcomes.|Through Week 24|The Safety Population consisted of all participants who received any part of an infusion of rituximab or placebo.||proportion of participants|||Number
159053|NCT00298233|Secondary|Median Time (Days) on Ventilation|Use of mechanical ventilation at any time for subjects with severe influenza and avian influenza.|Throughout study, 14 days|||days||95% Confidence Interval|Median
159054|NCT00298233|Secondary|Median Time (Days) in ICU||Throughout study, 14 days|||days||95% Confidence Interval|Median
159055|NCT00298233|Secondary|Median Time (Days) Receipt of Oxygen||Throughout study, 14 days|||days||95% Confidence Interval|Median
159056|NCT00298233|Secondary|In-hospital Mortality Rates|Standard therapy with oseltamivir is five days. Those patients with persistent symptoms on day five were continued on the randomized dose for an additional five days and assessments were performed up to day 10.|After up to 10 days of treatment|||participants|||Number
159057|NCT00298233|Secondary|Participants Meeting Criteria for Day 5 Clinical Failure|"Proportion of participants that have clinical failure by day 5. Subjects that meet one of the following on Day 5 will be classified as a clinical failure:~Severe tachypnea (respiratory rate ≥ 30 for ages ≥12 years, rate ≥ 40 for ages 6 to 12 years, rate ≥45 for ages 3 to 6 years, rate ≥ 50 for ages 1 to 3 years)~Severe dyspnea (unable to speak full sentences, or use of accessory respiratory muscles)~Arterial oxygen saturation ≤92% on room air by trans-cutaneous method~Need for mechanical ventilation or intensive care unit (ICU) admission For the purpose of endpoint definition, death prior to or on Day 5 will also be considered a clinical failure at Day 5."|After 5 days of treatment|For the purpose of endpoint definition, death prior to or on Day 5 was also considered as clinical failure on day 5.In the double dose cohort, only 154 subjects completed fives days of drug and 7 died (total 161). In the standard dose cohort only 149 subjects completed 5 days of drug and 9 died (total 158).||participants|||Number
159058|NCT00298233|Primary|Proportion of All Participants Negative for Viral RNA on Day 5|Proportion of all participants with no detectable viral RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) in a combined nasal and throat swab sample on day 5.|After 5 days of treatment|All randomized patients with RT-PCR proven influenza.||participants|||Number
159059|NCT00298090|Primary|Tissue Oxygen Saturation (StO2) Measurement on the Extremity With a Radial Arterial Line|Using near-infrared spectroscopy, the external device recorded raw StO2 values every 3.5 seconds for approximately 5 minutes prior to and immediately following the insertion of a radial arterial catheter on the ipsilateral side. The raw values were then compiled into one-minute averages.|up to 15 minutes|Data from 18 subjects not used due to only partial data captured resulting from logistical issues.||StO2 percent saturation||95% Confidence Interval|Mean
159060|NCT00297830|Secondary|Serum N-telopeplide Percent Change||24 months|Zero participants were analyzed because data was not collected. This was not a prespecified secondary outcome.|||||
159061|NCT00297830|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months|||percent change||95% Confidence Interval|Mean
159062|NCT00297830|Secondary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months|||percent change||95% Confidence Interval|Mean
159063|NCT00297830|Primary|Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months|BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer.|Baseline, 12 months|||percent change||95% Confidence Interval|Mean
159064|NCT00297778|Secondary|Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs||Baseline and Week 12|||participants|||Number
159065|NCT00297778|Secondary|Change From Baseline in the UPDRS Part IV Total Score at Week 12|The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
159066|NCT00297778|Secondary|Change From Baseline in the UPDRS Part I Total Score at Week 12|The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms.|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Inter-Quartile Range|Median
159067|NCT00297778|Secondary|Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12|The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 – 10 cm) line representing the patient’s degree of general pain. The two extremities of the line were taken to represent ‘no pain’ and ‘unbearable pain’, respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain).|Baseline and Week 12|FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data.||mm||Standard Error|Least Squares Mean
159068|NCT00297778|Secondary|Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12|This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)|Baseline and Week 12|FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data.||units on a scale||Inter-Quartile Range|Median
159069|NCT00297778|Secondary|Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12|The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)|Baseline and Week 12|FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data.||units on a scale||Inter-Quartile Range|Median
159070|NCT00297778|Secondary|Clinical Global Impressions of Global Improvement (CGI-I) at Week 12|The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse)|Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data.||units on a scale||Full Range|Median
159071|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II+III Total Score at Week 12|The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
159072|NCT00297778|Secondary|Change From Baseline in the UPDRS Part III Total Score at Week 12|The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms)|Baseline and Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
159073|NCT00297778|Secondary|Change From Baseline in the UPDRS Part II Total Score at Week 12|Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Standard Error|Least Squares Mean
159074|NCT00297778|Secondary|Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12|The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data.||units on a scale||Inter-Quartile Range|Median
159076|NCT00297778|Secondary|Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12|The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms)|Baseline and Week 12|FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data.||units on a scale||Standard Error|Least Squares Mean
159077|NCT00297778|Secondary|Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12|BDI clinical response was defined as a reduction of ≥50% from baseline|Week 12|FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score).||participants|||Number
159078|NCT00297778|Primary|Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12|The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)|Baseline and Week 12|The Full analysis set (FAS) made up of all randomised and treated participants with a baseline and at least one on-treatment assessment of the BDI. 9 participants from those randomised and treated were excluded due to insufficient BDI data.||Score on scale||Standard Error|Least Squares Mean
159079|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 39 had CDAI scores at Week 54 and Baseline and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
159080|NCT00297648|Secondary|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
159081|NCT00297648|Secondary|Change From Baseline in Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
159082|NCT00297648|Secondary|Change From Baseline in Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 had a CDEIS score at Week 54 and at Baseline and are included here. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
159083|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease|Week 10|Of the 89 patients in the Intent to Treat Population, 72 patients had plasma data and histological Crohn's disease score assessment at Week 10, and are included in this summary.||Pearson Correlation Coefficient||95% Confidence Interval|Number
159084|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation with a blinded assessment at Week 10. 48 patients had both CDEIS and CRP data at Week 10.||Pearson Correlation Coefficient||95% Confidence Interval|Number
159085|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data and a CDEIS score at Week 10 and are included in this summary.||Pearson Correlation Coefficient||95% Confidence Interval|Number
159086|NCT00297648|Secondary|Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|Of the 89 patients in the Intent to Treat Population, 73 patients had plasma level data and a CDAI score at Week 10 and are included in this summary.||Pearson Correlation Coefficient||95% Confidence Interval|Number
159087|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52|The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.|Baseline, Week 52|Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.||ratio||Full Range|Geometric Mean
159089|NCT00297648|Secondary|Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10|Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.||ratio||Full Range|Geometric Mean
159090|NCT00297648|Secondary|Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10||Week 10|Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.||mg/L||Full Range|Geometric Mean
159091|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159092|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159093|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 54|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159094|NCT00297648|Secondary|Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10|Crohn’s disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). CDAI is used to quantify the symptoms of Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.|Baseline, Week 10|The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159095|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
159096|NCT00297648|Secondary|Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment|The histological Crohn’s disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.||score on a scale||Standard Deviation|Mean
159097|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159098|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159099|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159100|NCT00297648|Secondary|Percentage of Patients With Endoscopic Complete Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159101|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159102|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159103|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159104|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn’s Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||Score on a scale||95% Confidence Interval|Mean
159105|NCT00297648|Secondary|Percentage of Patients With Endoscopic Remission (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score <6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159106|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100||percentage of patients||95% Confidence Interval|Number
159107|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159301|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
159108|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159109|NCT00297648|Secondary|Percentage of Patients With Endoscopic Response (Crohn’s Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159110|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159111|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 54|Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159112|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159113|NCT00297648|Secondary|Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments|Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn’s Disease Endoscopic Index of Severity) score|Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.||percentage of patients||95% Confidence Interval|Number
159114|NCT00297648|Primary|Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments|The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.|Baseline, Week 10|Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.||score on a scale||95% Confidence Interval|Mean
159115|NCT00297596|Secondary|Time to Progression||18 months||||||
159116|NCT00297596|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|18 months|||percentage of participants||95% Confidence Interval|Number
159117|NCT00297492|Primary|Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement|Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million|6 months|This was an intent-to-treat analysis. Those who were lost to follow-up were assumed to not be abstinent from smoking at the time of the 6 month follow-up.||participants|||Number
159118|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 4 weeks post true or sham acupuncture|||seconds||Standard Deviation|Mean
159119|NCT00297427|Secondary|Pelvic Floor Muscle Strength|Change in average duration of pelvic floor muscle contraction measured by electromyography. Subjects were instructed to tighten their pelvic floor muscles when prompted and hold the contraction until told to relax (up to 10 seconds). This was repeated three times and the duration of the contraction time was averaged.|Baseline and 1 week post true or sham acupuncture|||seconds||Standard Deviation|Mean
159120|NCT00297427|Secondary|Response to Booster Acupuncture if Needed|Change in the number of incontinent episodes per day following booster acupuncture|After the booster sessions|Participants who received booster acupuncture treatments during follow-up||incontinent episodes/day||Standard Deviation|Mean
159121|NCT00297427|Secondary|Need for Booster Acupuncture During Follow-up|The number of participants who were received true acupuncture (as their initial intervention or after initially receiving sham acupuncture) and were eligible to receive a booster (had a 50% or greater reduction in incontinent episodes following true acupuncture) and completed at least one month of follow-up and experienced a 30% or greater increase in incontinent episodes during follow up.|Monthly during the 6 month follow-up period|Participants who completed true acupuncture (as either their initial treatment or following sham acupuncture), had a 50% or greater reduction in incontinent episodes at 1 or 4 weeks post-true acupuncture, and completed at least one month of follow-up.||participants|||Number
159122|NCT00297427|Secondary|Burden Associated With the Acupuncture Treatment Protocol|Subjects' report of burden (difficulty) associated with the frequency, number and duration of treatment) and the position they had to remain in during the true and sham treatments. Subjects rate the difficulty associated with each of the four aspects of treatment on a 10-point scale ranging from 1 (not at all difficult) to 10 (extremely difficult). The burden score was calculated as the average of the scores on the 4 items with a possible range of 1 to 10 with higher scores indicating greater burden.|1 week post-treatment|The number of participants analyzed for this outcome was only those who completed the treatment protocol and the 1-week post-treatment visit. For this reason, the number is smaller than the number for the primary outcomes||units on a scale||Inter-Quartile Range|Median
159123|NCT00297427|Secondary|Adherence to Treatment Protocol|Percentage of acupuncture (true or sham) visits completed as scheduled|6 weeks|True and sham acupuncture subjects who completed the 6 weeks of treatment; participants who dropped out of the study during treatment were not included in this analysis||percent of visits||Standard Deviation|Mean
159124|NCT00297427|Secondary|Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years|Duration of urinary incontinence in years|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)||years||Standard Deviation|Mean
159125|NCT00297427|Secondary|Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)|Glasses/cups per day of non-caffeinated fluids (including water) at baseline|Baseline|Responders were subjects who achieved a 50% reduction in urinary incontinent episodes by 4 weeks post true acupuncture (as their initial or relayed intervention)||Glasses/cups per day||Standard Deviation|Mean
159126|NCT00297427|Secondary|Urodynamic Impression of Urge Urinary Incontinence|Documentation of a diagnostic impression of urge urinary incontinence following urodynamics|Baseline and 4 weeks post true or sham acupuncture|||participants|||Number
159127|NCT00297427|Secondary|Urodynamic Diagnostic Impression of Stress Urinary Incontinence|Documentation of a diagnostic impression of stress urinary incontinence following urodynamics|Baseline and 4 weeks post-treatment|||participants|||Number
159128|NCT00297427|Secondary|Change in Bladder Capacity|Measured by filling the bladder with sterile fluid until until the subject reported a strong urge to urinate.|Change from baseline to 4 weeks post-intervention|Subjects who agreed to have a cystometrogram at baseline and 4 weeks after completing acupuncture or sham acupuncture.||milliliters||Standard Deviation|Mean
159129|NCT00297427|Primary|Duration of Any Beneficial Effects|Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)|monthly during follow-up up to 6 months|Subjects who received true acupuncture and completed at least a 1-month follow-visit post acupuncture||Months||Standard Error|Mean
159130|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.|4-weeks post-intervention|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Mean
159131|NCT00297427|Primary|Incontinence-Specific Quality of Life|Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.|1 Week post-intervention|Intention-to-treat analysis||percentage change relative to baseline||Inter-Quartile Range|Median
159132|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.|4 weeks post true or sham acupuncture|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Median
159133|NCT00297427|Primary|Mental Health Related Quality of Life|Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.|1 week post-intervention|Intention to treat analysis||percentage change relative to baseline||Inter-Quartile Range|Median
159134|NCT00297427|Primary|Physical Health-Related Quality of Life|Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.|4-weeks post-intervention|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Median
159135|NCT00297427|Primary|Physical Health-Related Quality of Live|Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.|1 Week post-intervention|Intention-to-treat||percentage change relative to baseline||Inter-Quartile Range|Median
159136|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture|4 weeks post true or sham acupuncture|Intention-to-treat analysis||percent change in incontinent episodes||Standard Deviation|Mean
159137|NCT00297427|Primary|Percent Change in Incontinent Episodes|Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.|Baseline to 1 Week post-intervention|Intention-to-treat||percent change in incontinent episodes||Standard Deviation|Mean
159138|NCT00297258|Secondary|Overall Response|Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a >=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.|Baseline until either response or progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||participants|||Number
159139|NCT00297258|Secondary|Progression Free Survival|Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.|Start of therapy until progression (up to approximately 5 years)|Intent-to-Treat (ITT) Population: all eligible participants who had started therapy. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||years||90% Confidence Interval|Median
159140|NCT00297258|Secondary|Overall Survival|Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.|Start of therapy until death (up to approximately 5 years)|ITT Population. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||years||90% Confidence Interval|Median
159141|NCT00297258|Primary|Progression Free Survival at Week 12|Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a >=20% increase in target lesions.|Week 12|Intent-to-Treat (ITT) Population: All eligible participants entered into the study and who had taken >=1 dose of investigational product. Four participants were considered not evaluable for efficacy by the study coordinator for one of the following reasons: absence of target lesions, documented progression at trial entry, or ineligible histology.||participants|||Number
159142|NCT00297232|Primary|Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0|Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.|Up to 480 weeks|Participants with EDSS improvement (regardless of length of follow-up) sustained for 24 weeks.||weeks||Inter-Quartile Range|Median
159143|NCT00297232|Primary|Time to 48-week Confirmed EDSS Progression|Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 48 weeks.||weeks||Inter-Quartile Range|Median
159144|NCT00297232|Primary|Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression|Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.|up to 480 weeks|Participants with EDSS progression (regardless of length of follow-up) sustained for 24 weeks.||weeks||Inter-Quartile Range|Median
159145|NCT00297167|Other Pre-specified|Percentage of Stools With Blood|Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||percentage of stools with blood per day||Standard Deviation|Mean
159146|NCT00297167|Other Pre-specified|Percentage of Visible Oil or Grease in Stool|Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||percentage of visible oil or grease/day||Standard Deviation|Mean
159147|NCT00297167|Secondary|Mean Number of Abdominal Symptoms|Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||symptoms per day||Standard Deviation|Mean
159302|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159148|NCT00297167|Secondary|Percentage of Stool Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||percentage of stools||Standard Deviation|Mean
159149|NCT00297167|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.|Day 3 up to Day 6 during first and second double-blind intervention periods|Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.||stools per day||Standard Deviation|Mean
159150|NCT00297167|Secondary|Vitamin E Levels|Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||mg/L||Standard Deviation|Mean
159151|NCT00297167|Secondary|Vitamin A Levels|Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||microgram per liter (mcg/L)||Standard Deviation|Mean
159152|NCT00297167|Secondary|Lipid Levels|Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.|End of treatment (Day 6 during first and second double-blind intervention periods)|"Safety population included all participants who received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specific time point in each treatment arm."||milligram/deciliter (mg/dL)||Standard Deviation|Mean
159153|NCT00297167|Secondary|Percent Coefficient of Nitrogen Absorption (CNA%)|Percent CNA was calculated as ([nitrogen intake-nitrogen excretion]/nitrogen intake)*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||percent CNA||Standard Error|Least Squares Mean
159154|NCT00297167|Primary|Percent Coefficient of Fat Absorption (CFA%)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.|Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods|"Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure."||percent CFA||Standard Error|Least Squares Mean
159155|NCT00297115|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
159156|NCT00297115|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.||mg/L||95% Confidence Interval|Least Squares Mean
159157|NCT00297115|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.||days||Standard Deviation|Mean
159158|NCT00297115|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
159159|NCT00297115|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
159160|NCT00297115|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
159161|NCT00297102|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period|The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from –3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from –9 to +9.|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||scores on a scale||Standard Error|Least Squares Mean
159162|NCT00297102|Secondary|Natural Log-transformed C-reactive Protein (CRP)|Mean change from baseline to the last post randomization measurement in natural log-transformed CRP|Change from baseline to last post randomization measurement (52 weeks)|ITT analysis. Number of participants analyzed = number of participants with data available.||mg/L||95% Confidence Interval|Least Squares Mean
159163|NCT00297102|Secondary|Time to Mortality Due to Any Reason||52 weeks treatment period|ITT analysis. Number of participants analyzed = number of participants who died.||days||Standard Deviation|Mean
159164|NCT00297102|Secondary|Post-bronchodilator FEV1 [L]|Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
159165|NCT00297102|Primary|COPD Exacerbation Rate (Moderate or Severe)|Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].|52 weeks treatment period|ITT analysis.||exacerbations per patient per year||95% Confidence Interval|Mean
159166|NCT00297102|Primary|Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]|Change from baseline over 52 weeks of treatment|ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.||mL||Standard Error|Least Squares Mean
159167|NCT00297037|Secondary|The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters.|Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.|0, 1, 2, 4, 6 weeks|||mm||Full Range|Mean
159168|NCT00297037|Secondary|The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10).|The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks|||units on a scale||Full Range|Mean
159169|NCT00297037|Primary|The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.|The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).|0, 1, 2, 4, 6 weeks|ITT using last observation carried forward for missing data||units on a scale||Full Range|Mean
159170|NCT00296816|Secondary|Median Overall Survival Time|"Survival was the observed length of life from entry into the study to death or the date of last contact.~The median overall survival time was estimated using Kaplan-Meier Curve."|up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||days||90% Confidence Interval|Median
159171|NCT00296816|Secondary|Overall Survival Rate|"Survival was the observed length of life from entry into the study to death or the date of last contact.~The overall survival rate (percentage of participants showing survival) at 12 and 24-months is reported here."|up to up to approximately 1700 days after treatment initiation|Intent-to-treat population - All participants who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||percentage of participants||95% Confidence Interval|Number
159172|NCT00296816|Secondary|CA-125 Response Rate|"A CA-125 response was considered at least a 50% reduction in the level of the biomarker, CA-125, from a pretreatment level, which was confirmed and maintained for at least 28 days.~The overall CA-125 biomarker response rate was defined as the number of participants in the measurable disease subgroup who met the above criteria at least once within the study treatment period +21 days, divided by the number of evaluable participants in the disease subgroup."|up to 12 months after treatment initiation|All participants with non-measurable and measurable disease at baseline, and a pretreatment sample that was at least twice the ULN value for CA-125 within 2 weeks of first study treatment.||percentage of participants||95% Confidence Interval|Number
159173|NCT00296816|Secondary|Median Time to Recurrence-free Survival (RFS) in Participants With Non-measurable Disease at Baseline|"The time to RFS was programmatically defined as the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.~Participants were~censored on the last available CA 125 biomarker blood draw date if~left the study prior to disease progression or death~they received off-study anti-tumor medication~underwent debulking surgery~censored at Day 1 if they were alive had no post baseline CA 125 biomarker blood draw."|up to approximately 1500 days following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.||days||95% Confidence Interval|Median
159303|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
159174|NCT00296816|Secondary|Twelve-month Recurrence-free Survival (RFS) Rate in Participants With Non Measurable Disease at Baseline|"Participants with Recurrence-free survival (RFS) were participants with a non-measurable disease at baseline, who had not achieved disease progression nor had died.~Disease progression included the following:~the appearance of a new lesion~symptomatic deterioration~progression of non-target lesions~a predefined serum CA 125 increase.~RFS rate was the percent of participants in the non-measurable disease subgroup who achieved RFS."|up to 12 months following treatment initiation|All participants with non-measurable disease at baseline, except for those at one site that closed prematurely, as their data was not available for efficacy measures.||percentage of participants||95% Confidence Interval|Number
159175|NCT00296816|Secondary|Tumor Response Rate Based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST)|"Tumors were assessed by CT and MRI. Tumor response was evaluated by GOG RECIST in which:~Complete response (CR) was the disappearance of all target and non-target lesions, with no evidence of new lesions~Partial response (PR) was at least a 30% decrease in the sum of longest dimensions (LD) of all measurable target lesions~Participants with a response (CR or PR) were to have the initial response confirmed by tumor imaging in 4-6 weeks."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||participants|||Number
159176|NCT00296816|Secondary|Median Time to Progression-free Survival (PFS)|"Time to PFS was the interval from the date of registration to the earliest date of disease progression or death, whichever occurred first.~Time of PFS was censored~on the last available tumor assessment date for participants leaving the study prior to disease progression or death; and also for participants requiring off-study medication or additional debulking surgery (where assessment date used was the one prior to off-study medication or surgery),~at Day 1, for living participants with no post-baseline tumor assessments.~Median PFS was estimated from a Kaplan-Meier curve."|up to approximately 1300 days following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||days||95% Confidence Interval|Median
159177|NCT00296816|Secondary|Twenty Four-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).~Disease progression was recorded as any one of the following:~appearance of a new lesion~symptomatic deterioration~progression of target or nontarget lesions~death~Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 24 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||percentage of participants||95% Confidence Interval|Number
159178|NCT00296816|Primary|Twelve-month Progression-free Survival (PFS) Rate in Participants|"Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST).~Disease progression was recorded as any one of the following:~appearance of a new lesion~symptomatic deterioration~progression of target or nontarget lesions~death~Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS."|up to 12 months following treatment initiation|Intent-to-treat population with measurable disease at baseline - All participants with measurable disease at baseline who received study drugs, except for participants from one site which was closed prematurely, and for whom efficacy data was not available.||percentage of participants||95% Confidence Interval|Number
159179|NCT00296647|Primary|6 Month Self-reported Abstinence From Smoking|Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)|6 months|intent to treat||participants|||Number
159180|NCT00296517|Secondary|Safety: Adverse Events by Organ System Class, Intensity, and Frequency|Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.|Baseline to Week 12|Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.||Number of events|||Number
159181|NCT00296517|Secondary|Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12|Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).|Week 12|Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).||participants|||Number
159182|NCT00296517|Secondary|Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12|The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.|Baseline to Week 8 and Week 12|Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percentage of Responders||95% Confidence Interval|Mean
159183|NCT00296517|Secondary|Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12|The 7-point Clinical Global Impressions–Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 8, and 12|Full Analysis Set||Points on scale||Standard Deviation|Mean
159184|NCT00296517|Secondary|Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.||percent change in score||Standard Deviation|Mean
159185|NCT00296517|Secondary|Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.||points on a scale||Standard Deviation|Mean
159186|NCT00296517|Secondary|Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percentage of Remitters||95% Confidence Interval|Mean
159187|NCT00296517|Secondary|Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percentage of Responders||95% Confidence Interval|Mean
159188|NCT00296517|Secondary|Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98||Percent Change in score||Standard Deviation|Mean
159189|NCT00296517|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline to Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98||Score in a scale||Standard Deviation|Mean
159190|NCT00296517|Secondary|Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Week 8 and Week 12|Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98||Score in scale||Standard Deviation|Mean
159191|NCT00296517|Primary|Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score|The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).|Baseline and Week 12|Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160||Score in scale||Standard Deviation|Mean
159192|NCT00296504|Secondary|Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.||participants|||Number
159193|NCT00296504|Secondary|Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions|The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving FPV or NFV in Studies APV30001 and APV30002.||participants|||Number
159194|NCT00296504|Secondary|Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline|The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.||participants|||Number
159195|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Weeks 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||log 10 copies per milliliters||Full Range|Median
159196|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.||log 10 copies per milliliter||Full Range|Median
159197|NCT00296504|Secondary|Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.|Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.||log 10 copies per milliliter||Full Range|Median
159198|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 24, 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.||cells per millimeters cubed (cells/mm^3)||Full Range|Median
159199|NCT00296504|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis|Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 48, 120, 168, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.||cells per millimeters cubed (cells/mm^3)||Full Range|Median
159200|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.|Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.||percentage of participants|||Number
159201|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.|Baseline and Weeks 12, 24, 48, 60, 96, and 132|All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.||percentage of participants|||Number
159202|NCT00296504|Secondary|Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)|Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.|Baseline and Weeks 48, 120, 180, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.||percentage of participants|||Number
159203|NCT00296504|Primary|Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||units per liter (U/L)||Inter-Quartile Range|Median
159204|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.||units per liter (U/L)||Inter-Quartile Range|Median
159227|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159205|NCT00296504|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216|Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.||units per liter (U/L)||Inter-Quartile Range|Median
159206|NCT00296504|Primary|Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||ratio||Inter-Quartile Range|Median
159207|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168|Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 132, and 168|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.||ratio||Inter-Quartile Range|Median
159208|NCT00296504|Primary|Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216|blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216|All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.||ratio||Inter-Quartile Range|Median
159209|NCT00296504|Primary|Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432|Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).|Weeks 120, 180, 204, 216, and 432|All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
159210|NCT00296504|Primary|Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216|Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).|Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.||milligrams per deciliter (mg/dl)||Inter-Quartile Range|Median
159211|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Final Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Post January 2006; for up to 241 weeks|All participants who remained in the study after January 31, 2006.||participants|||Number
159212|NCT00296504|Primary|Number of Participants With Any Adverse Event (AE): Interim Analysis|"An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section."|Baseline (Day 1) up to 31 January 2006 (up to Week 264)|All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.||participants|||Number
159213|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of rescue-free days||Standard Error|Mean
159214|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of rescue-free days||Standard Error|Mean
159215|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population|Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of asthma symptom-free days||Standard Error|Mean
159216|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Percentage of asthma symptom-free days||Standard Error|Mean
159217|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||L/sec||Standard Error|Mean
159218|NCT00296491|Secondary|Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population|Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||L/sec||Standard Error|Mean
159219|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)|The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.|Baseline To 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Points on a Scale||Standard Error|Mean
159220|NCT00296491|Secondary|Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).|The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)|Baseline to 1-2 Weeks|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method.||Points on a Scale||Standard Error|Mean
159221|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol.||L/min||Standard Error|Mean
159222|NCT00296491|Primary|Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population|Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.|Baseline to Endpoint (weeks 3-4)|The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment.||L/min||Standard Error|Mean
159223|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159224|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159225|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159226|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159228|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in ApoA1 at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159229|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159230|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159231|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159232|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159233|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159234|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159235|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159236|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159237|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159238|NCT00296400|Secondary|Correlation of Change From Baseline in eGFR With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159239|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159240|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159241|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159297|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
159242|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159243|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159244|NCT00296400|Secondary|Correlation of Changes From Baseline in eGFR With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159245|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159246|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159247|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks|||Correlation coefficient|||Number
159248|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159249|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159250|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159251|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159252|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159253|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159254|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159298|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159255|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159256|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159257|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159258|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TG at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159259|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159260|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159261|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159262|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159263|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159264|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in LDL-C at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159265|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 52|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159266|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Albumin/Creatinine Ratio With Percent Change From Baseline in TC at Week 26|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159267|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159268|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB/ApoA-1 Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159269|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoB at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159270|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein B [ApoB] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159271|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in ApoA-1 at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159272|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Apolipoprotein A-1 [ApoA-1] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159273|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159274|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159275|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159276|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159277|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159278|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TC/HDL-C Ratio at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159279|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in TG at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159280|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Triglyceride [TG] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159281|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in nonHDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159282|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol [nonHDL-C] at Week 26|"Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.~)"|Baseline and 26 weeks|||Correlation coefficient|||Number
159283|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in HDL-C at Week 52|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 52 weeks|||Correlation coefficient|||Number
159284|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in High Density Lipoprotein Cholesterol [HDL-C] at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|26 weeks|||Correlation coefficient|||Number
159285|NCT00296400|Secondary|Correlation of Changes From Baseline inUrinary Protein/Creatinine Ratio With Percent Change From Baseline in LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks|||Correlation coefficient|||Number
159286|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 26|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|Baseline and 26 weeks|||Correlation coefficient|||Number
159287|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 52.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|52 weeks|||Correlation coefficient|||Number
159288|NCT00296400|Secondary|Correlation of Changes From Baseline in Urinary Protein/Creatinine Ratio With Percent Change From Baseline in Total Cholesterol [TC] at Week 26.|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26. (Correlation values range from -1 to +1. -1 indicates a perfect negative linear relationship while a +1 indicates a perfect linear positive relationship. A value of zero indicates no relationship.)|baseline and 26 weeks|||Correlation coefficient|||Number
159289|NCT00296400|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]|The change from baseline in eGFR at Week 52 [LOCF] is the Week 52 value or last observation carried forward minus baseline value.|Assessed at baseline and Week 52 [LOCF]|||mL/min||Standard Deviation|Mean
159290|NCT00296400|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26|The change from baseline in eGFR at Week 26 is the Week 26 value minus baseline value.|Assessed at baseline and Week 26|||mL/min||Standard Deviation|Mean
159291|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 52 [LOCF]|||ratio||95% Confidence Interval|Geometric Mean
159292|NCT00296400|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at baseline and Week 26|||ratio||95% Confidence Interval|Geometric Mean
159293|NCT00296400|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 26|||ratio||95% Confidence Interval|Geometric Mean
159294|NCT00296400|Primary|Urinary Protein/Creatinine Ratio at Week 52 [LOCF]|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at baseline and Week 52 (LOCF)|||ratio||95% Confidence Interval|Geometric Mean
159295|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
159296|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159304|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159305|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
159306|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159307|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
159308|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TG|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159309|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 weeks|||Correlation coefficient|||Number
159310|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159311|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159312|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159313|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159314|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159315|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159316|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: eGFR and TC|Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159317|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159318|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159319|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159320|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159321|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159322|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159323|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159324|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159325|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159326|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159327|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159328|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159329|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159330|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159331|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159332|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159333|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159334|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159335|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159336|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159337|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159338|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC|Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159339|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159340|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159341|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159342|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159343|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159344|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159345|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159346|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159347|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159348|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159349|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159350|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159351|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159352|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159353|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159354|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159355|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159356|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159357|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|52 Weeks|||Correlation coefficient|||Number
159358|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.|26 weeks|||Correlation coefficient|||Number
159359|NCT00296374|Secondary|Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52|Assessed at 52 Weeks|||Correlation coefficient|||Number
159360|NCT00296374|Secondary|Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes|Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).|52 weeks|||Correlation coefficient|||Number
159361|NCT00296374|Secondary|Change From Baseline in eGFR at Week 52 [LOCF]||Assessed at Baseline and Week 52 [LOCF]|||mL/min||Standard Deviation|Mean
159362|NCT00296374|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26||Assessed at Baseline and Week 26|||mL/min||Standard Deviation|Mean
159363|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 52 LOCF|||mg/g||95% Confidence Interval|Geometric Mean
159364|NCT00296374|Secondary|Urinary Albumin/Creatinine Ratio at Week 26|Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.|Assessed at Week 26|||mg/g||95% Confidence Interval|Geometric Mean
159365|NCT00296374|Secondary|Urinary Protein/Creatinine Ratio at Week 26.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 26|||mg/g||95% Confidence Interval|Geometric Mean
159366|NCT00296374|Primary|Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.|Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.|Assessed at Week 52, Last observation carried forward (LOCF)|||mg/g||95% Confidence Interval|Geometric Mean
159367|NCT00296335|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years|Up to 3 years|||participants|||Number
159368|NCT00296335|Secondary|Overall Survival Rate|Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.|3 years|||percentage of participants||95% Confidence Interval|Number
159369|NCT00296335|Primary|Relapse-free Survival Rate|"Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery.~Relapse was defined as any new tumor lesion."|3 years|Intention-to treat population||percentage of participants||95% Confidence Interval|Number
159370|NCT00296322|Secondary|Overall Survival||3 years|||percentage of participants||95% Confidence Interval|Number
159371|NCT00296322|Secondary|Toxicity Profile (According to NCI CTC Version 2.0)|Because safety profile in oncology study is evaluated for each toxicity, it is impossible to present the overall patient number. Instead, we presented the number of patients who declined study therapy due to adverse events or patient will.|up to 1 year|||participants|||Number
159372|NCT00296322|Primary|Relapse-free Survival||3 years|||percentage of participants||95% Confidence Interval|Number
159373|NCT00296244|Secondary|New-onset Diabetes Mellitus (NODM) as Secondary Outcome|The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups.|6 months|||Percentage of participants|||Number
159374|NCT00296244|Secondary|Incidence and Severity of HCV Recurrence Post-OLT|The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups.|6 months post-transplant|Only patients with HCV cirrhosis as the main indication for OLT were included in this analysis||Percentage of participants|||Number
159375|NCT00296244|Secondary|Infection as an Adverse Effect of Steroids|Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection|3 months post-transplant|||Percentage of participants|||Number
159376|NCT00296244|Primary|Acute Rejection Rate|Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive|6 months post-transplant|||Percentage of participants|||Number
159377|NCT00296244|Primary|Patient Survival Rate|Percentage of recipients who are still alive at the end of 1 and 2 years.|1 and 2 years|||Percentage of participants|||Number
159378|NCT00296244|Primary|Graft Survival Rate|Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.|1 and 2 years|||percentage of participants|||Number
159379|NCT00296231|Secondary|Transcutaneous CO2 Measurements as a Trend Throughout Intervention|We used a transcutaneous CO2 monitor (TCOM) as a safety device throughout the study. We analyzed the change in TCOM readings recorded every 30 minutes (5 measurements) to determine safety|2 hours|||torr||Standard Deviation|Mean
159380|NCT00296231|Primary|pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values|Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control.|2 hours|||mm Hg||Standard Deviation|Mean
159381|NCT00296192|Secondary|"Time of First Off Reversal"|"Number of minutes to first reversal of symptoms from off to on. Estimated via Kaplan-Meier estimation method. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.||minutes||95% Confidence Interval|Median
159382|NCT00296192|Secondary|"Success Rate (Percentage of Subjects Achieving Off Reversals)"|"Subjects reversing from off to on following initiation of treatment. On and off state refer to periods where Parkinson's disease symptoms are not present (on) and periods where symptoms are present (off); the on/off determination at each assessment timepoint was made by the investigator."|Up to 6 hours post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.||percentage of participants|||Number
159383|NCT00296192|Secondary|Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)|One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).|Baseline and 34 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 34 minutes post-dose timepoint were not imputed; number of observations at 34 minutes post-dose timepoint may be less than that for baseline timepoint.||taps per minute||Standard Deviation|Mean
159384|NCT00296192|Secondary|Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination|The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson’s disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value.|Baseline, and 24 minutes post-dose|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 24 minutes post-dose timepoint were not imputed; number of observations at 24 minutes post-dose timepoint may be less than that for baseline timepoint.||score on a scale||Standard Deviation|Mean
159385|NCT00296192|Primary|Number of Subjects Who Complete the Trial||15 days|Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.||participants|||Number
159386|NCT00295880|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD).|Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.|1 year post transplant|Only 7 patients were at risk for chronic GVHD||Participants|||Number
159387|NCT00295880|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)|Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.|100 days post transplant|2 patients were not yet graded for acute gvhd||Participants|||Number
159388|NCT00295880|Secondary|Number of Patients Surviving at Day 100 and 1 Year.|Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.|Day 100 and 1 year|||Participants|||Number
159389|NCT00295880|Secondary|Number of Patients With Transplant-related Mortality (TRM)|Number of patients who were deceased at days 100 and 180 from any cause other than relapse.|Day 100 and Day 180|||Participants|||Number
159390|NCT00295880|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD)|Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.|100 days post transplant|2 patients were not graded for acute GVHD due to graft failure.||Participants|||Number
159391|NCT00295880|Secondary|Number of Patients With Evidence of Engraftment.|Number of patients who received both cord blood units and achieved sustained donor engraftment|1 year|1 patient was not evaluable due to graft failure||Participants|||Number
159392|NCT00295880|Secondary|Number of Patients Achieving Neutrophil Recovery|Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.|6 months|Patients who completed treatment.||Participants|||Number
159393|NCT00295880|Primary|Median Number of Days to Neutrophil Engraftment|Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.|Daily through Day 60 post transplant|||Days||Full Range|Median
159394|NCT00295854|Primary|"Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA)"|The primary endpoint was the GRA overall change “in their condition” at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.|8 weeks|||participants|||Number
159395|NCT00295854|Secondary|Number of Responders for GRA Assessment in Their Condition at Week 4.|Responders were defined as patients who were ‘moderately improved’ or ‘markedly improved’ and non-responders were defined as patients who were ‘markedly worse’, ‘moderately worse’, ‘mildly worse’, no change, or ‘mildly improved’ on the GRA assessments.|4 weeks|||participants|||Number
159396|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|12 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.||participants|||Number
159397|NCT00295750|Secondary|The Mean Value of QTc Interval as Measured by Electrocardiogram|The QTc interval results are calculated with Fridericia’s correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.|12 months|ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.||milliseconds||Standard Deviation|Mean
159398|NCT00295750|Secondary|Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)|Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.|Baseline to Day 364|ITT population||participants|||Number
159399|NCT00295750|Secondary|Participants Grouped by Time to Prostate-specific Antigen Failure|The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.|12 months|ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.||participants|||Number
159400|NCT00295750|Secondary|Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28|Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.|Days 14 and 28|ITT population.||percent change||Inter-Quartile Range|Median
159401|NCT00295750|Secondary|Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252|Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252.|Day 252, Day 255, and Day 259|ITT population who had blood samples drawn on Day 252, Day 255, and Day 259.||participants|||Number
159402|NCT00295750|Secondary|Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3|This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.|3 days|ITT population.||percentage of patients||95% Confidence Interval|Mean
159403|NCT00295750|Secondary|Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment|A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).|2 weeks|ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.||percentage of patients||95% Confidence Interval|Mean
159404|NCT00295750|Primary|Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364|Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.|12 months|Intent-to-treat (ITT) population.||percentage of patients||95% Confidence Interval|Mean
159405|NCT00295633|Secondary|Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24|Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg*min/dL||Standard Error|Mean
159406|NCT00295633|Secondary|Percentage of Participants Achieving A1c <7% at Week 24|Percentage of participants achieving A1C < 7%, the American Diabetic Association’s defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.|Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, subjects must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||Percentage of participants|||Number
159407|NCT00295633|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline in FPG at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.||mg/dL||Standard Error|Mean
159408|NCT00295633|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline in A1C at Week 24, adjusted for baseline value.|Baseline, Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.||percent||Standard Error|Mean
159409|NCT00295503|Secondary|Overall Survival|overall survival was measured from time of initiation of treatment to death from any cause|from time of enrollment to death from any cause. Patients still alive at study end were censored with a minimum follow up of 6 months.|||months||95% Confidence Interval|Median
159410|NCT00295503|Secondary|Response Rate|response was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months|||percentage of participants|||Number
159411|NCT00295503|Primary|Progression Free Survival Rate at 6 Months|This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.|patients progression free at 6 months|||percentage of participants|||Number
159412|NCT00295490|Secondary|Adverse Event Reporting|To identify Group differences between the number of adverse event recorded by patient for both serious and non serious adverse events, as well as events considered being attributable to the study medication.|Baseline and weeks 2,4,6,8,12 and 16|Zero participants were analysed as the study was terminated prematurely||Participants||95% Confidence Interval|Number
159413|NCT00295490|Secondary|Complementary and Alternative Medicine Beliefs Inventory|Questionnaire to assess changes in attitudes and health beliefs to CAM.the questionnaire as 17 questions, each scored on a 7 point likert scale from strongly disagree to strongly agree; a higher score indicates stronger belief in the measure. Minimum score 17, maximum score 119|four monthly|Zero participants were analysed as the study was terminated prematurely||unit on scale||95% Confidence Interval|Mean
159414|NCT00295490|Secondary|Patient Global Assessment|To assess changes in the subject’s well-being based on 7 point likert scale ranging from very poor (0 point) to very good (7 point). Outcome was recorded at baseline, week 8 and end of treatment at week 16. We reported outcome as the change in patient global assessment from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely||Unit on scale (Likert from very poor to||95% Confidence Interval|Mean
159415|NCT00295490|Secondary|Short Form-36 (SF-36)|Quality of Life assessment containing 8 scales clustered into 2 summary scales: physical health and mental health. Each question is scored out from 0 (indicating worst health) to 100 (indicating best health). Mean scores for the 8 scales (total scores/no questions completed) are calculated to give a total score for each of the two summary scales between 0 (worst health) and 100 (best health). SF36 was recorded at baseline, week 8 and at the end of treatment at week 16. we reported the change from baseline to end of treatment as the outcome.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit of scale||95% Confidence Interval|Mean
159416|NCT00295490|Secondary|Stiffness Subscale on the The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on two questions addressing stiffness in osteoarthritis;a higher score indicating worse symptoms. The VAS used terminators of no stiffness (0mm) to extreme stiffness (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit on 100mm VAS scale||95% Confidence Interval|Mean
159417|NCT00295490|Secondary|Disability Subscale on The Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on twelve questions addressing disability in osteoarthritis with a higher score indicating worse symptoms. The VAS used terminators of no disability (0mm) to extreme disability (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.|baseline, 8 and 16 weeks|Zero participants were analysed as the study was terminated prematurely||unit on 100mm VAS scale||95% Confidence Interval|Mean
159418|NCT00295490|Secondary|Pain Subscale on Western Ontario and Mc Master University OA Index|Subscale assessed by 100mm VAS based on five questions addressing pain in osteoarthritis using the terminators no pain (0mm) to extreme pain (100mm). a higher score therefore indicates more severe pain. This outcome was recorded at baseline, week 8 and week 16 (end of treatment). The outcome for this study was reported as the change in WOMAC pain score from baseline to end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit on 100mm VAS scale||95% Confidence Interval|Mean
159419|NCT00295490|Primary|Western Ontario and Mc Master University OA Index (WOMAC)|WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.|Baseline, week 8 and week 16|Zero participants were analysed as the study was terminated prematurely.||Unit on 100mm scale||Standard Deviation|Mean
159420|NCT00295061|Primary|Alpha-1 MP vs. Prolastin® of Area Under the Curve (AUC) From Day 0 to Day 7|"The primary objective of this study was to demonstrate the pharmacokinetic comparability (geometric least square mean ratio of AUC between the Alpha-1 MP vs. Prolastin®, 90% confidence interval falls within 0.80-1.25, FDA Guidance as being bioequivalent between two treatments) of Alpha-1 MP to Prolastin® in subjects with alpha-1-anti-trypsin (AAT) deficiency by comparing AUC from Day 0 to Day 7 of plasma Alpha1-PI measured by the functional activity (potency) assay. AUC from Day 0 to Day 7 was calculated at steady state at the end of the first and second 8-week treatment periods during the 16-week double-blind, crossover phase."|Day 0 to Day 7|||mg*h/mL|||Number
159421|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:~ODI score improved by at least 15% from baseline;~SF-36 score improved from baseline;~Neurologic parameters maintained or improved from baseline;~No re-operations required to modify or remove the implant; and~Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.~A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:~Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|60 Months|Patients who completed all 60 month visit analyses||percentage of overall successes|||Number
159422|NCT00295009|Primary|Overall Success|"Overall success was a composite endpoint.~A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:~ODI score improved by at least 15% from baseline;~SF-36 score improved from baseline;~Neurologic parameters maintained or improved from baseline;~No re-operations to modify or remove the implant; and~Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.~A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:~Same as above~Same as above~Same as above~No re-operations to modify the fusion site or correct a complication with an implant; and~Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies"|24 Months|Patients who completed all 24 month visit analyses||percentage of overall successes|||Number
159423|NCT00294762|Secondary|Duration of Tumor Response|Median length of time that tumor showed any type of response, ie, CR, PR, or SD|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).|All patients who had any type of tumor response, ie, CR, PR, or SD||Months||Full Range|Median
159424|NCT00294762|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment||Percent of Patients|||Number
159425|NCT00294762|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 29.0 months)|All patients who received at least 1 dose of study drug||Months||Full Range|Median
159426|NCT00294762|Secondary|Overall Survival at 12 Months|Percentage of patients alive after 12 months of study treatment|12 months from 1st dose|All patients who received at least 1 dose of study drug||Percent of Patients||95% Confidence Interval|Number
159427|NCT00294762|Secondary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression, as assessed every 21 days (maximum 28.8 months)|All patients who received at least 1 dose of study drug||months||Full Range|Median
159428|NCT00294762|Primary|6-month Progression-free Survival|Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|6 months after first dose|All patients who received at least one dose of study drug.||Percentage of Patients||95% Confidence Interval|Number
159429|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 104-195|Safety analysis set is all subjects who entered the year 3 extension at week 104.||episodes|||Number
159430|NCT00294723|Secondary|Hypoglycaemic Episodes|Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.|weeks 0-104|Full safety analysis set is all subjects who had been exposed to at least one dose of the study products.||episodes|||Number
159431|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159432|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159433|NCT00294723|Secondary|Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159434|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Error|Least Squares Mean
159435|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159436|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159437|NCT00294723|Secondary|Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52|Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159438|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 156|Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159439|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 104|Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159440|NCT00294723|Secondary|Change in Fasting Plasma Glucose at Week 52|Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||mg/dL||Standard Error|Least Squares Mean
159441|NCT00294723|Secondary|Change in Body Weight at Week 156|Change in body weight from baseline (week 0) to 156 weeks|week 0, week 156|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
159442|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Error|Least Squares Mean
159443|NCT00294723|Secondary|Change in Body Weight at Week 104|Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)|week 0, week 104|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
159444|NCT00294723|Secondary|Change in Body Weight at Week 52|Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||kg||Standard Error|Least Squares Mean
159483|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Ventricular Pacing Increase Greater Than 30 Percent at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
160285|NCT00286741|Primary|Systolic Blood Pressure||12 months|||mmHg||Standard Deviation|Mean
159445|NCT00294723|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)|week 0, week 52|Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.||percentage point of total HbA1c||Standard Error|Least Squares Mean
159446|NCT00294658|Secondary|Treatment Associated Symptoms (TAS)|Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Patients were in and out by visit||Participants|||Count of Participants
159447|NCT00294658|Secondary|Treatment Associated Complications (TAC)|Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.|Month 0, 1, 2, 3, 4 then every 3 months through Month 36|Participants were in and out by each visit.||Participants|||Count of Participants
159448|NCT00294658|Secondary|Short Form-36 Standardized Mental Component|Range from 0 to 100, the higher the mental component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.||units on a scale||Full Range|Median
159449|NCT00294658|Secondary|Short Form-36 Standardized Physical Component|Range from 0 to 100, the higher the physical component value, the better the mental health.|Month 0, Month 12, Month 24 and Month 36|Participants were in and out by visit.||units on a scale||Full Range|Median
159450|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)|baseline to 3 years|||days||Standard Deviation|Mean
159451|NCT00294658|Secondary|Cumulative Days in Hospital for Myasthenia Gravis Exacerbation|Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)|baseline to 2 years|||days||Standard Deviation|Mean
159452|NCT00294658|Secondary|Minimal Manifestation (MM) Status at Month 12, 24 and 36|Number of participants who were in minimal manifestation status at month 12, 24 and 36.|Month 12, 24 and 36|Number analyzed: Thymectomy plus prednisone: n=61 (Month 12), 59 (Month 24) , and 58 (Month 36); Prednisone alone n=54 (Month 12), 53 (Month 24), and 51 (Month 36)||participants|||Number
159453|NCT00294658|Secondary|Intravenous Immunoglobulin Use||baseline to 3 years|||participants|||Number
159454|NCT00294658|Secondary|Plasma Exchange Use||baseline to 3 years|||participants|||Number
159455|NCT00294658|Secondary|Azathioprine Use||baseline to 3 years|||participants|||Number
159456|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36|MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life.|Month 12, 24, and 36|Participants were in and out at month 12, 24 and 36 visit.||units on a scale||Standard Deviation|Mean
159457|NCT00294658|Secondary|Time-Weighted Average MG Activity of Daily Living (MG-ADL)|MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.|baseline, month 4, 6 and every 3 months through 36 months|Five participants in each group did not provide the information to enable calculation of the time-weighted average MG activity of daily life over 3 years.||units on a scale||Standard Deviation|Mean
159458|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)|For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
159459|NCT00294658|Secondary|Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)|For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the penalized time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
159460|NCT00294658|Secondary|Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)|Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period.|baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average prescribed alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
159461|NCT00294658|Secondary|Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years|||events|||Number
159462|NCT00294658|Secondary|Cumulative Number of Hospital Days|Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)|baseline to 3 years|||days||Standard Deviation|Mean
159463|NCT00294658|Secondary|Hospitalization for Exacerbation of Myasthenia Gravis||baseline to 2 years and baseline to 3 years|Number of participants who had hospitalized over 2 and 3 years||participants|||Number
159464|NCT00294658|Secondary|Classification of Serious Adverse Events||baseline to 3 years|One participant might had experienced more than one serious adverse event.||participants|||Number
159465|NCT00294658|Secondary|Number of Patients With at Least One Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years|||participants|||Number
159466|NCT00294658|Secondary|Number of Serious Adverse Events|Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)|baseline to 3 years|||events|||Number
159467|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 2 in Thymectomy plus prednisone group and 4 in Prednisone alone group did not provide age at disease onset information.||mg||Standard Deviation|Mean
159468|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
159469|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of time-weighted average alternate-day prednisone dose (mg) over 3 years. Another 1 in Prednisone alone group did not provide prednisone use at enrollment information.||mg||Standard Deviation|Mean
159470|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted average Quantitative Myasthenia Gravis Weakness Score over 3 years. Another 2 participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the age at disease onset information.||units on a scale||Standard Deviation|Mean
159471|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.||units on a scale||Standard Deviation|Mean
159472|NCT00294658|Secondary|Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in Thymectomy plus prednisone and 5 in Prednisone alone group did not provide information to enable the calculation of Time-weighted average Quantitative Myasthenia Gravis Score by prednisone use at enrollment over 3 years.||units on a scale||Standard Deviation|Mean
159473|NCT00294658|Primary|Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years|Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.|baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months|Five participants in Thymectomy plus prednisone and 4 in Prednisone alone group did not provide the information to enable calculation of the time-weighted average alternate-day prednisone dose (mg) over 3 years.||mg||Standard Deviation|Mean
159474|NCT00294658|Primary|Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years|Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.|baseline, month 3, 4, 6 and every 3 months through 36 months|Four participants in each group did not provide the information to enable calculation of the time-weighted Quantitative Myasthenia Gravis Weakness Score over 3 years.||units on a scale||Standard Deviation|Mean
159475|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Elective Replacement Indicator/Battery End of Life (ERI/EOL) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
159476|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Ventricular Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
159477|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Change in Atrial Lead Impedance at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.||Percentage of participants|||Number
159478|NCT00294645|Secondary|Percentage of Participants With an Increase in Ventricular Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
159479|NCT00294645|Secondary|Percentage of Participants With an Increase in Atrial Pacing Voltage Threshold Greater Than 1 Volt (V) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.||Percentage of participants|||Number
159480|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Ventricular Capture at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|||Percentage of participants|||Number
159481|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Loss of Atrial Capture at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|Analysis used subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed.||Percentage of participants|||Number
159482|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Non-sustained Ventricular Tachycardia at 12 Months|Compare time to first diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
176013|NCT00068237|Secondary|Salivary Scan Evaluation||From start of treatment to 6 months||||||
159484|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Atrial Tachycardia/Atrial Fibrillation Greater Than 48 Hours at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment|Cohort was subset of full cohort excluding participants with single chamber devices, thus the variance in number analyzed vs other endpoint analyses.||Percentage of participants|||Number
159485|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of Sensed Ventricular Rate Greater Than 100 Beats Per Minute (BPM) During Atrial Tachycardia/Atrial Fibrillation at 12 Months|Compare time to diagnosis in Control and Remote arms|One year post-enrollment|||Percentage of participants|||Number
159486|NCT00294645|Secondary|Percentage of Participants With First Diagnosis of New Onset Atrial Tachycardia/Atrial Fibrillation (AT/AF) at 12 Months|Compare time to first diagnosis in Remote and Control arms|One year post-enrollment|Only participants without a history of Atrial Tachycardia/Atrial Fibrillation were included in analysis of this objective.||Percentage of participants|||Number
159487|NCT00294645|Secondary|Proportion of Actions Taken in Response to the Diagnosis of Clinically Actionable Events|Actions categories include: Referral, Office Visit, Medication (Med) Change, Hospitalization, Emergency Room (ER) Visit, Device Reprogrammed, System Modification, Increase Monitoring, Other|One year post-enrollment|||Total number actions/total number CAEs|||Number
159488|NCT00294645|Primary|Percentage of Participants With First Diagnosis of Clinically Actionable Events (CAE) at 12 Months|Clinically Actionable Events (CAE) are 12 events that were identified based on their relation to other comorbidities that may increase the risk of a serious cardiac event. The CAEs consist of several arrhythmias and device performance parameters such as: Atrial Tachycardia/Atrial Fibrillation (AT/AF) and loss of capture.|One year post-enrollment|||Percentage of participants|||Number
159489|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.|24 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
159490|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.|18 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
159491|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.|9 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
159492|NCT00294515|Secondary|Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.|6 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
159493|NCT00294515|Primary|Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant|Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.|12 months post-transplant|Intent-to-treat population||Percentage of patients||95% Confidence Interval|Mean
159494|NCT00294398|Secondary|Asthma-related Quality of Life|Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.|2 months|Analysis population was based on the intention to treat number at enrollment.||units on a scale||Standard Deviation|Mean
159495|NCT00294398|Primary|Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)|Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.|2 months|Analysis population was based on the intention to treat number at enrollment.||Participants|||Number
159496|NCT00294060|Primary|Multiple In-clinic Visits|Follow-up practice pattern assessed by the number of patients with a dual chamber device that had two or more routine pacemaker in-clinic visits with a device interrogation|implant to one year|Only those patients with a dual chamber device completing 12 months of follow-up were included in this analysis.||participants with 2 or more visits|||Number
159497|NCT00294060|Primary|Days Hospitalized|Healthcare utilization clinical outcome characterized by number of days hospitalized in the first year|implant to one year|Patients with a twelve-month follow-up visit were included in the analysis.||average days hospitalized||Standard Deviation|Mean
159498|NCT00294060|Primary|Number of Participants With Dual Chamber Devices|Pacemaker device choice characterized by the number of patients with dual chamber devices|at original implant|||Participants with dual chamber devices|||Number
159499|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
160286|NCT00286741|Secondary|Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).||one year||||||
159500|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159501|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159502|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159503|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159504|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159505|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159506|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen||Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159507|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159508|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159509|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
160287|NCT00286741|Primary|Hemoglobin A1c||12 months|||percentage points||Standard Deviation|Mean
159510|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159511|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159512|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159513|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if~the same HPV type was found in at least one of the two (closest) preceding cytology samples, or~none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types)"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159514|NCT00294047|Secondary|Number of Subjects With Pregnancies and Their Outcomes.|Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159515|NCT00294047|Secondary|Number of Subjects Reporting Medically Significant Conditions (MAEs).|Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159516|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).||Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159517|NCT00294047|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).|NOCDs include autoimmune disorders, asthma and type I diabetes.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159518|NCT00294047|Secondary|Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159519|NCT00294047|Secondary|Number of Subjects Reporting Related or Fatal Serious Adverse Event.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
160288|NCT00286728|Secondary|Mental Health Services Use and Costs at 6 Months, 1 Year, and 2 Years||6 months, 1 year, 2 years||||||
176014|NCT00068237|Secondary|Rate of Acute Xerostomia||From start of treatment to 90 days||||||
159520|NCT00294047|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.|Up to Month 48 and up to Month 84|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159521|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 unsolicited AE = an event that prevented normal activity.~A related AE = event assessed by the investigator as causally related to the study vaccination."|Within 30 days (Days 0 – 29) post-vaccination period.|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159522|NCT00294047|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C.|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.||Subjects|||Number
159523|NCT00294047|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.||Subjects|||Number
159524|NCT00294047|Secondary|Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.|"Titers are expressed as geometric mean antibody titers (GMTs).~Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination.~ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%"|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Titers||95% Confidence Interval|Geometric Mean
159525|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.|Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%|Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Subjects|||Number
159526|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).~Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||EL.U/mL||95% Confidence Interval|Geometric Mean
159527|NCT00294047|Secondary|Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.|"GMCs were expressed in ELISA units per milliliter (EL.U/mL).~Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||EL.U/mL||95% Confidence Interval|Geometric Mean
159537|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
161329|NCT00276094|Primary|Mean Change From Baseline in Vaginal pH||Baseline (Screening) to Week 12|||pH||Standard Deviation|Mean
159528|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Subjects|||Number
159529|NCT00294047|Secondary|Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.|"Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immuno subset=subjects from selected sites N≥1000, at least 250 per region"|At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84|The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.||Subjects|||Number
159530|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.~The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)"|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159531|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159532|NCT00294047|Secondary|Number of Subjects With First Colposcopy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159533|NCT00294047|Secondary|Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy|Detection was done on all subjects irrespective of their baseline HPV DNA status.|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159534|NCT00294047|Secondary|Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.~HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159535|NCT00294047|Secondary|Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159536|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done on all subjects irrespective of their baseline HPV DNA status."|Up to Month 48|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.||Subjects|||Number
159591|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy and CAM|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Cells per mm^3||Full Range|Mean
159538|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159539|NCT00294047|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.~Note: Results for seropositive status were not analysed."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159540|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).~Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus.~HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159541|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.|"Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.~HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159542|NCT00294047|Secondary|Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159543|NCT00294047|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in:~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159552|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159592|NCT00293293|Secondary|Average Natural Killer Cell Count Levels Before Chemotherapy Alone|Natural killer cells are identified as CD3 (-), CD56(+) and CD16 (+). Phenotypic analysis and measurement of NK cells (NK cell count in mm^3 drawn before chemotherapy) using flow cytometry and specific mAb.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Cells per mm^3||Full Range|Mean
159544|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159545|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus|Up to Month 84|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159546|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).|"CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159547|NCT00294047|Primary|Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.|"CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.~Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)~Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus"|Up to Month 48|The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.||Subjects|||Number
159548|NCT00293813|Secondary|Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
159549|NCT00293813|Primary|Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12|Cortical Thickness measured by XtremeCT.|12 months|Randomized subjects who receive at least 1 dose of investigational product and have a baseline and at least 1 post baseline evaluation before or at month 12. Last Observation Carried Forward used as imputation method. Summarised for actual treatment taken.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
159550|NCT00293722|Other Pre-specified|Change From Baseline in Patient Global Assessment of Disease Activity at Week 52|Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||millimeter||Standard Deviation|Mean
159551|NCT00293722|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants’ quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159588|NCT00293293|Secondary|Comparison of Average White Blood Cell Count in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from white blood cell counts collected during treatment phase of study; average applied.|Prior to Chemotherapy through 6th Treatment with Chemotherapy (average 6 months)|||cells/mm^3||Standard Deviation|Mean
170546|NCT00123682|Primary|7-day Point Prevalence Abstinence From Smoking||6 month|||percentage of participants|||Number
159553|NCT00293722|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159554|NCT00293722|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
159555|NCT00293722|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||participants|||Number
159556|NCT00293722|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||millimeter||Standard Deviation|Mean
159557|NCT00293722|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant’s reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159558|NCT00293722|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159559|NCT00293722|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||percentage of BSA||Standard Deviation|Mean
159560|NCT00293722|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study and had safety data available.||percentage of participants|||Number
159561|NCT00293709|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52|SF-12 questionnaire was used to determine participants’ quality of life (QoL). It comprised 12 items which covered 8 concepts : physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159589|NCT00293293|Secondary|Comparison of Number of Patients Who Were Hospitalized After Chemotherapy Alone vs. Chemotherapy Plus CAM|Count of patients who were admitted to the hospital after receiving chemotherapy treatment or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Participants|||Number
159562|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Pain at Week 52|Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159563|NCT00293709|Secondary|Change From Baseline in Patient Assessment of Itching at Week 52|Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159564|NCT00293709|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||milligram per deciliter (mg/dL)||Standard Deviation|Mean
159565|NCT00293709|Secondary|Number of Participants With Nail Involvement|Number of participants with psoriatic arthritis affecting the nails are reported.|Baseline, Week 12, 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||participants|||Number
159566|NCT00293709|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 52|Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||millimeter||Standard Deviation|Mean
159567|NCT00293709|Secondary|Change From Baseline in Ritchie Index at Week 52|Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant’s reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159568|NCT00293709|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159569|NCT00293709|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52|PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Week 52|Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||units on a scale||Standard Deviation|Mean
159570|NCT00293709|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52||Baseline, Week 52|Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were evaluable for this measure at given time point.||percentage of BSA||Standard Deviation|Mean
159590|NCT00293293|Secondary|Comparison of Number of Patients Having Infection After Chemotherapy Alone vs. Chemotherapy Plus CAM|Number of patients that had infections requiring antibiotic therapy or admission to the hospital that received either chemotherapy alone or chemotherapy plus complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Participants|||Number
159727|NCT00292370|Secondary|PANSS,HAMD,CGI,DTS, PSQI,PSQI-A, Dream/Sleep Diary,Q-LES-Q,SDS,ASEX,AIMS, BAS, SAS||Baseline to endpoint change scores||||||
171554|NCT00113425|Secondary|Change From Baseline in Cysts at Week 16||Baseline and Week 16|||cysts||95% Confidence Interval|Mean
159571|NCT00293709|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Baseline up to Week 52|Safety analysis set included all participants who were enrolled in this study.||percentage of participants|||Number
159572|NCT00293579|Secondary|Overall Survival|Overall survival was measured from the time of initial study entry to death due to any cause.|Up to 2 years|All patients were deceased at the time of terminating this study.||months||Full Range|Median
159573|NCT00293579|Secondary|Impact of Pemetrexed Chemotherapy on Quality of Life|Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).|Baseline, End of Treatment [up to 3 years]|||Units on a scale||Standard Deviation|Mean
159574|NCT00293579|Secondary|Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer|Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Up to 3 years|||percent of patients|||Number
159575|NCT00293579|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 3 years|||patients|||Number
159576|NCT00293540|Primary|Overall Survival|Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.|Up to 9 years|Analyzed all patients with followup data||years||95% Confidence Interval|Median
159577|NCT00293462|Secondary|Pain Questionnaire|Severity and quality of pain by questionnaires (0-10 with higher scores indicating more pain) at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were averages together to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.||units on a scale||Standard Deviation|Mean
159578|NCT00293462|Secondary|Functional Status by Karnofsky Performance Status Scale|Functional status by Karnofsky Performance Status Scale (0-100 with higher scores indicating better functional status) at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean.|baseline through 3 months|Of the intent to treat population, subjects who did not fill out the baseline Karnofsky functional scales were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.||units on a scale||Standard Deviation|Mean
159579|NCT00293462|Secondary|Quality of Life During Radiation Therapy|Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Quality of Life is measured with a scale that ranges from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean.|at baseline, during radiation therapy, and once a month for 3 months after radiation therapy|Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.||units on a scale||Standard Deviation|Mean
159580|NCT00293462|Primary|Treatment Phase (Begins at Onset of Mucositis): Comparison of Three Groups to Evaluate the Effectiveness of the Two Mouthwashes.|To evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring. The number of days for mucositis to heal.|From onset of mucositis to healing of mucositis. Actual time variable. Mean: 95.8 days (SD 46.8)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash||Healing Days||Standard Error|Mean
159581|NCT00293462|Primary|Prevention Phase (Prior to Onset of Mucositis): Compare GG and SS Prior to Onset of Mucositis to Evaluate the Incidence of Radiation Therapy-induced Oral Mucositis|Incidence of grade 1 or 2 oral mucositis by Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy.|Prevention Phase (prior to onset of mucositis): Baseline to onset of mucositis. Actual time variable, mean time: 16.18 days (SD 7.4)|Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash||participants|||Number
159582|NCT00293384|Secondary|Toxicity Grade 3, 4, or 5||at 0-120 hours|||participants|||Number
159583|NCT00293384|Other Pre-specified|Overall Nausea Controlled||at 0-120 hours|||participants|||Number
159584|NCT00293384|Secondary|Delayed Vomiting Controlled||at 25-120 hours|||participants|||Number
159585|NCT00293384|Primary|Proportion of Participants With Controlled Acute Vomiting|No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.|at 0-24 hours|Evaluable for response||participants|||Number
159586|NCT00293293|Secondary|Comparison of Average Salivary IgA Level in Chemotherapy Alone vs. Chemotherapy Plus CAM|Determined from collection of saliva during treatment phase of study and recorded in mg/dL units.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||mg/dL||Standard Deviation|Mean
159587|NCT00293293|Secondary|Comparison of Average T-lymphocytes and B-lymphocytes for Chemotherapy Alone vs. Chemotherapy Plus CAM|Average count determined - collected during treatment phase of study - Includes T-helper/inducer, CD4 and CD8 cells; number of CD4 and CD8 cells (in mm^3).|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||cells/mm^3||Standard Deviation|Mean
161842|NCT00267631|Primary|Diagnosis of Infectious Disease|The Children visiting the ED having an infectious disease|30 minutes|||Participants|||Number
159593|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Plus CAM|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient after receiving chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Dose (mg) per participant||Standard Deviation|Mean
159594|NCT00293293|Secondary|Average Anti-Emetic Dose Use After Chemotherapy Alone|Determined by averaging the total dose of anti-emetic medications given (in milligrams) per patient.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Dose (mg) per participant||Standard Deviation|Mean
159595|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy + CAM|Determined by averaging the total number of anti-emetic prescriptions given per patient after chemotherapy and complementary alternative medicine.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).||Prescriptions per participant||Standard Deviation|Mean
159596|NCT00293293|Secondary|Average Number of Anti-Emetic Prescriptions Used After Chemotherapy Alone|Determined by averaging the total number of anti-emetic prescriptions given per patient after receiving chemotherapy.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|Patients that received 6 cycles of chemotherapy alone.||Prescriptions per participant||Standard Deviation|Mean
159597|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Plus CAM|Number of patients who had to delay their chemotherapy treatments and or complementary alternative medicine due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||Participants|||Number
159598|NCT00293293|Secondary|Number of Patients With Delays In Receiving Chemotherapy Alone|Number of patients who had to delay their chemotherapy treatments due to side effects.|Prior to Chemotherapy (Day -2 to +1) through Cycle 6 Chemotherapy (Approx. 168-180 Days)|||participants|||Number
159599|NCT00293293|Primary|Comparison of Mental Health Inventory (MHI) Questionnaire Results - Average for Chemotherapy Alone vs. Chemotherapy Plus CAM|The MHI asks questions about how the consumer is feeling and coping with usual life activities. It provides measurable information about the consumer's wellbeing (anxiety, depression, loss of emotional control, general positive affect and emotional ties). A single score based on all items designed as high level summary index of the person's mental health status. High scores on the Mental Health Index indicate greater psychological well being and relatively less psychological distress (range is 38-240).|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy|||Scores on a scale||Full Range|Mean
159600|NCT00293293|Primary|Quality of Life Comparison - Average FACT-O Scoring in Chemotherapy Alone vs. Chemotherapy Plus Complementary Alternative Medicine (CAM)|Measured by Functional Assessment of Cancer Therapy—Ovarian (FACT-O) questionnaire was used to assess patients' quality of life before each chemotherapy cycle. It is a standardized self-administered questionnaire measuring many aspects of quality of life (0 to 4; Not at all, A little bit, Some-what, Quite a bit, Very much) as related to patients with ovarian cancers. The quality of life measures include the total FACT-O score (minimum value 0, maximum value 200). Questionnaires are recoded in the final analysis phase so that a higher score reflected more adverse effects on quality of life.|Prior to Cycle 1 (Day -2 to +1), Every 3rd cycle (1 cycle = approx 21 days) and 6 Months Post Chemotherapy|||Scores on a Scale||Full Range|Mean
159601|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
159602|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
159603|NCT00293267|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
159604|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
159605|NCT00293267|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
159606|NCT00293267|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
159607|NCT00293267|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159608|NCT00293267|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159609|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159610|NCT00293267|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL)|Baseline and Week 16|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: baseline carry-~forward for all failures/discontinued due to lack of efficacy"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159611|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants|||Number
159612|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
159613|NCT00293267|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
159614|NCT00293267|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
159615|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
159616|NCT00293267|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
159617|NCT00293267|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
159618|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)|Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3)|Baseline and Week 240|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (Cells/mm^3)||95% Confidence Interval|Mean
159619|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)|Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3)|Baseline and Week 156|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
159620|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3)|Baseline and Week 48|"Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.~Participants with virologic failure after Week 16 are treatment failures for virologic efficacy analyses."||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
159621|NCT00293254|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16|Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3)|Baseline and Week 16|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 cell count (cells/mm^3) was carried forward for participants who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm^3)||95% Confidence Interval|Mean
162171|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-2 at Baseline||Baseline (Cycle 1, Day 1)|FA Set||pg/mL||Full Range|Median
159622|NCT00293254|Secondary|Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL)|Baseline and Week 240|"Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy~Participants with virologic failure after Week 16 = treatment failures"||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159623|NCT00293254|Secondary|Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)|Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL)|Baseline and Week 156|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159624|NCT00293254|Secondary|Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48|Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL)|Baseline and Week 48|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159625|NCT00293254|Secondary|Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16|Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL)|Baseline and Week 16|Observed mean change from baseline in log10 plasma HIV RNA calculated using conventional imputation (replace <400 copies by 400 copies if signal detected; 200 copies if not detected); Missing values: Baseline carry-forward for all failures/discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
159626|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free).|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants|||Number
159627|NCT00293254|Secondary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240|240 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
159628|NCT00293254|Secondary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156|156 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
159629|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48|48 Weeks|Participants who experienced virologic failure after Week 16 are also counted as treatment failures for the subsequent virologic efficacy analyses.||Percentage of Participants||95% Confidence Interval|Number
159630|NCT00293254|Secondary|Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
159631|NCT00293254|Primary|Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240|240 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
159632|NCT00293254|Primary|Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156|156 Weeks|"The analysis population was based on a non-completer equals failure approach where missing values for participants who discontinued the study for any reason were considered treatment failures.~Participants who experienced virologic failure after Week 16 are counted also as treatment failures for the subsequent virologic efficacy analyses."||Percentage of Participants||95% Confidence Interval|Number
159633|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48|48 Weeks|||Percentage of Participants||95% Confidence Interval|Number
159634|NCT00293254|Primary|Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16|Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16|16 Weeks|||Percentage of Participants||95% Confidence Interval|Number
159635|NCT00293241|Secondary|Health State|Endpoint: Health State evaluation with the EQ-5D questionnaire (range 0-100) . A measure of 100 is better and a measure of 0 is worse.|2 years post-implant|Patients with health evaluation completed at 24 months follow-up||units on a Health State scale||Standard Deviation|Mean
159636|NCT00293241|Secondary|Atrial Pacing Percentage|Endpoint: Cumulative percentage atrial pacing documented in the device memory|2 years post-implant|||percentage atrial pacing||Inter-Quartile Range|Median
159637|NCT00293241|Secondary|Patient Symptoms|Endpoint: Symptoms evaluated at enrollment, 12 months and 24 months followup|Implant to 2 years post-implant|||participants|||Number
159638|NCT00293241|Secondary|Change in PR Interval, Change in QRS Duration and Change in P-wave Duration|Endpoint: Change in PR interval, Change in QRS duration and Change in P-wave duration evaluated at enrollment and 24 Month FU|Implant to 2 years post-implant|||milliseconds||Standard Deviation|Mean
159639|NCT00293241|Secondary|Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients|Endpoint: Patient implanted with a replacement ICD developing a class 1 pacemaker indication|Implant to 2 years post-implant|||participants|||Number
159640|NCT00293241|Secondary|Duration of Cardiovascular Related Hospitalizations|Endpoint: Duration of Cardiovascular Hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.||Days of CV hospitalizations||Inter-Quartile Range|Median
159641|NCT00293241|Secondary|Number of Cardiovascular Related Hospitalizations|Endpoint: Number of Cardiovascular hospitalizations per subject|Implant to 4 years post-implant|All participants were followed for 4 years. Those not hospitalized were excluded from the analysis.||Number of CV Hospitalizations||Inter-Quartile Range|Median
159642|NCT00293241|Secondary|Stroke|Endpoint: Stroke|Implant to 2 years post-implant|||participants|||Number
159643|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant|Time to patient death from any cause|Implant to 2 years post-implant|||participants|||Number
159644|NCT00293241|Secondary|Incidence of High Voltage Therapies|Endpoint: A high voltage therapy delivered|Implant to 2 years post-implant|||participants|||Number
159645|NCT00293241|Secondary|Change in the Use of Cardiovascular Medication Over Time|Endpoint: Use of Diuretics, ACE Inhibitors, Beta-Blockers, digitalis, calcium antagonists and antiarrhythmic drugs at enrollment, and 1month, 12 months, and 24 mnths after implant|Implant to 2 years post-implant|||participants|||Number
159646|NCT00293241|Secondary|Change in Use of Anticoagulation|Endpoint: Use of Anticoagulation at enrollment and every follow-up visit|Implant to 2 years post-implant|||participants|||Number
159647|NCT00293241|Secondary|Change in New York Heart Association (NYHA) Functional Class|"Endpoint: NYHA classification at Baseline, one year and 2 year post-implant. (Class I is considered a better category and Class IV is considered worse) I Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.~II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.~IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases."|Baseline, one year and 2 year post-implant|||Participants|||Number
159648|NCT00293241|Secondary|Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time|Endpoint: LVEF (%) difference between 2 year post implant and baseline|Implant to 2 years post-implant|||LVEF (%) difference||Standard Deviation|Mean
159649|NCT00293241|Secondary|Ventricular Pacing Percentage|Endpoint: Cumulative percentage ventricular pacing documented in the device memory|Implant to 2 years post-implant|||Percentage Ventricular Pacing||Inter-Quartile Range|Median
159650|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant|"Time to development of permanent AF fulfilling one of the following criteria:~7 days in a row with device diagnostic showing 20 or more hours in AT/AF and cardioversion failed or~7 days in a row with device diagnostic showing 20 or more hours in AT/AF and the investigator decides not to cardiovert the patient"|Implant to 2 years post-implant|||participants|||Number
159651|NCT00293241|Secondary|Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant|"Time to first event of atrial tachycardia/ atrial fibrillation (AT/AF) fulfilling one of the following criteria:~7 days in a row with device diagnostic showing 20 or more hours in AT/AF or~a cardioversion was done to terminate AT/AF or~the patient is during 2 consecutive follow-up (FU) visits in AT/AF"|Implant to 2 years post-implant|||participants|||Number
159652|NCT00293241|Secondary|Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.|Time to first event of death or cardiovascular (CV) hospitalization from implant to 2 years post-implant|Implant to 2 years post-implant|||participants|||Number
159653|NCT00293241|Primary|Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant|"Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant.~Hospitalization is defined as:~admission to hospital involving one overnight stay or~emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition~Cardiovascular is defined as new or worsening:~heart failure (HF),~angina,~myocardial infarction (MI),~any arrhythmia,~stroke,~transient ischemic attack (TIA),~acute peripheral vascular emergencies,~pulmonary embolism."|Implant to 2 years post-implant|Patients indicated for Implantable Pulse Generator (IPG) or Implantable Cardioverter Defibrillator (ICD) replacement with a history of right ventricular pacing > 40%, to be allocated to either Managed Ventricular Pacing (MVP) programming, or conventional dual chamber programming (DDD) without MVP||number of participants|||Number
159654|NCT00293059|Post-Hoc|Change in Absolute Value From Baseline MBL to end-of Study MBL|The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||mL||Standard Deviation|Mean
159655|NCT00293059|Post-Hoc|Proportion of Participants With Successful Treatment|End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.|during a time period of 28 days under treatment|Only participants with heavy menstrual bleeding were included in the analysis.||Proportion of participants|||Number
159656|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 196|Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data||g/dL||Standard Deviation|Mean
159657|NCT00293059|Secondary|Change From Baseline in Hemoglobin Concentration at Treatment Day 84|Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data||g/dL||Standard Deviation|Mean
159658|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 196|Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data||ng/mL||Standard Deviation|Mean
159659|NCT00293059|Secondary|Change From Baseline in Serum Ferritin Concentration at Treatment Day 84|Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.|baseline and treatment day 84|ITT, excluding participants with missing data||ng/mL||Standard Deviation|Mean
159660|NCT00293059|Secondary|Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196|Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.|baseline and treatment day 196|ITT, excluding participants with missing data||Percentage of blood volume||Standard Deviation|Mean
159661|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159662|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196|Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159663|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159664|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159665|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159666|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159667|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities.|treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159668|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196|Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159669|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196|Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 196|ITT, excluding participants with missing data||days||Standard Deviation|Mean
159670|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196|Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159671|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84|Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159672|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84|Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159673|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84|Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159674|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84|Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159675|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84|Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159676|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84|Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159677|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.|treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159678|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84|Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.|treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159679|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84|Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.|treatment day 84|ITT, excluding participants with missing data||day||Standard Deviation|Mean
159680|NCT00293059|Secondary|Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84|Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.|treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159681|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196|The visual analogue scale (ie, “thermometer”) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159682|NCT00293059|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84|The visual analogue scale (ie, “thermometer”) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked ‘your own health state today’ to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented.|baseline and treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159683|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159684|NCT00293059|Secondary|Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84|The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented.|baseline and treatment day 84|ITT, excluding participants with missing data||scores on a scale||Standard Deviation|Mean
159685|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196|The MFSQ was designed to measure aspects of female sexuality and asked about the participants’ sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159686|NCT00293059|Secondary|Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84|The MFSQ was designed to measure aspects of female sexuality and asked about the participants’ sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.|baseline and treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
161642|NCT00271544|Secondary|Fluoroscopy Time|Fluoroscopy time was defined as the total time the fluoroscope was imaging.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
159687|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 196|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159688|NCT00293059|Secondary|Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84|The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.|baseline and treatment day 84|ITT, excluding participants with missing data||Scores on a scale||Standard Deviation|Mean
159689|NCT00293059|Secondary|Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment|The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||Sanitary protection products||Standard Deviation|Mean
159690|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment|A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||bleeding episodes||Standard Deviation|Mean
159691|NCT00293059|Secondary|Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment|The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.|baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||bleeding days||Standard Deviation|Mean
159692|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.|28 days|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
159693|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.|28 days|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
159694|NCT00293059|Secondary|Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle.|28 days|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
159695|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment|The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.|baseline and reference period of 90 days under treatment|ITT, participants with excessive bleeding at baseline||mL||Standard Deviation|Mean
159696|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 7|Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles|28 days|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
159697|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 3|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles|28 days|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
159698|NCT00293059|Secondary|Menstrual Blood Loss Volume for All Participants at Cycle 1|Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle|28 days|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
159699|NCT00293059|Secondary|Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment|Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.|Baseline and reference period of 90 days under treatment|ITT, excluding participants with missing data||mL||Standard Deviation|Mean
159700|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant’s Overall Assessment Scale at Treatment Day 196|Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
160095|NCT00289536|Secondary|Weight-adjusted Clearance|Computed as weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||mL/kg*hour||Full Range|Median
159701|NCT00293059|Secondary|Proportion of Participants With Improvement in the Participant’s Overall Assessment Scale at Treatment Day 84|Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159702|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 196|The investigators assessed the participants’ change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 196|ITT, excluding participants with missing data||Proportion of participants|||Number
159703|NCT00293059|Secondary|Proportion of Participants With Improvement in the Investigator’s Global Assessment Scale at Treatment Day 84|The investigators assessed the participants’ change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.|from baseline up to treatment day 84|ITT, excluding participants with missing data||Proportion of participants|||Number
159704|NCT00293059|Secondary|Proportion of Participants Cured From Excessive Bleeding|Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with excessive bleeding.||Proportion of participants|||Number
159705|NCT00293059|Secondary|Proportion of Participants Cured From Frequent Bleeding|Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with frequent bleeding.||Proportion of participants|||Number
159706|NCT00293059|Secondary|Proportion of Participants Cured From Prolonged Bleeding|Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.|during a time period of 90 days under treatment|The ITT population consisted of all randomized participants who enrolled with prolonged bleeding.||Proportion of participants|||Number
159707|NCT00293059|Primary|Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms|Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant’s total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in.|during a time period of 90 days under treatment|The intent-to-treat (ITT) group consisted of all randomized participants.||Proportion of participants|||Number
159708|NCT00291876|Secondary|Number of Subjects Reporting Pregnancies After Additional Vaccination|The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.|At Months 186 and 198|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subject|||Number
159709|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.~4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
159710|NCT00291876|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint.||Subjects|||Number
159711|NCT00291876|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~4 subjects received additional vaccination at Month 186 and 1 at Month 198."|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
159712|NCT00291876|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.~4 subjects received additional vaccination at Month 186 and 1 subject at Month 198."|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
159713|NCT00291876|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.|During the 4-day (Days 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||subjects|||Number
159714|NCT00291876|Secondary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.~Please note that value 14.9 means <15."|Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||mIU/mL|||Number
159715|NCT00291876|Primary|Number of Seropositive Subjects Against Hepatitis A Virus|A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. *The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.||Subjects|||Number
159716|NCT00291876|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.|At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246|"Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.~* The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging."||mIU/mL||95% Confidence Interval|Geometric Mean
159717|NCT00293020|Primary|Percentage of Participants With Adverse Events.|After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.|Participants were followed for the duration of the study, an average of 126 days|All subjects that received at least 1 dose of study drug were included in the analysis.||percentage of participants|||Number
159718|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.||hours|Participants|95% Confidence Interval|Median
159719|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered.||hours|Participants|95% Confidence Interval|Median
159720|NCT00292981|Secondary|Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)|Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.|Up to Day 9 following an attack|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.||hours||95% Confidence Interval|Median
159721|NCT00292981|Primary|Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)|The start of symptom relief was determined by subject self-assessment.|Up to 24 h after start of study treatment|Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication.||hours||95% Confidence Interval|Median
159722|NCT00292591|Primary|25-Hydroxyvitamin D Concentration|Circulating total 25(OH)D concentration measured in serum at visit 7, one month prior to delivery|7 months|||ng/mL||Standard Deviation|Mean
159723|NCT00292461|Secondary|Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.||Baseline and 16 weeks|||percentage of participants|||Number
159724|NCT00292461|Secondary|Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period||Baseline and 16 weeks|||participants|||Number
159725|NCT00292461|Secondary|Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period||Baseline and 16 weeks|||participants|||Number
159726|NCT00292461|Primary|The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline|Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment|Baseline and 16 weeks|ITT (intent-to-treat)||percent change||Full Range|Median
159728|NCT00292370|Primary|Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.|The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.|From baseline (week 8) to endpoint (week 16 or termination)|||units on a scale||Standard Deviation|Mean
159729|NCT00292318|Secondary|Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)|Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.|The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Data were not collected due medical instruments to measure this outcome were removed by VA staff causing the study to be terminated.|||||
159730|NCT00292318|Primary|"Patient Report of Adequate Relief From FI Symptoms With a Yes Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A Responder Will be Defined as One Who Provides a Yes Answer."|Only reporting the results of participants who reported adequate relief.|The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.|Only participants that completed the full number of study visits were analyzed.||participants|||Number
159731|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159732|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159733|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159734|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159735|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159736|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159799|NCT00292162|Primary|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)|Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %|Baseline|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study||percentage of blood ejected in one beat||Standard Deviation|Mean
159737|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159738|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159739|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159740|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159741|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159742|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159743|NCT00292227|Secondary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)|Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h|Safety population within the placebo patch group; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159744|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159769|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Total Score|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
159745|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.|Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159746|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.|Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159747|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.|Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159748|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.|Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159749|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.|Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159750|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.|Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159751|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.|Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159752|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.|Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159817|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters|Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
159753|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.|Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159754|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.|Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159755|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.|Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159756|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.|Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159757|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.|Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159758|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.|Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159759|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.|Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159760|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.|Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159818|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters|Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng/mL||Standard Deviation|Mean
159761|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.|Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159762|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.|Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159763|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.|Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159764|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.|Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159765|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.|Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159766|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.|Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159767|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.|Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159768|NCT00292227|Primary|Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)|Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.|Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h|Safety population; only non-missing values were analyzed.||milliseconds [ms]||Standard Deviation|Mean
159819|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters|Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||hours||Full Range|Median
159770|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Frequency|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
159771|NCT00292188|Secondary|Davidson Trauma Scale (DTS): Severity|Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.|Baseline, Week 8|FAS, LOCF. Number of subjects with evaluable data: (n=pregabalin, placebo), respectively.||score on a scale||Standard Deviation|Mean
159772|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
159773|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
159774|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
159775|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 119, 121 for pregabalin, placebo respectively.||particpants|||Number
159776|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
159777|NCT00292188|Secondary|Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning|The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.|Baseline, Week 8|FAS, LOCF. The number of subjects that answered the question at Week 8 is 120, 121 for pregabalin, placebo respectively.||participants|||Number
159778|NCT00292188|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score|Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.|Week 8|FAS. Number of subjects with a non-missing NPSI Total Intensity Score at Baseline and Week 8 (using LOCF) is 100, 106 for pregabalin, placebo respectively.||percentage score on scale||Standard Error|Least Squares Mean
159779|NCT00292188|Secondary|Modified Brief Pain Inventory Short Form (m-BPI-sf)|Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.|Baseline, Week 8|Baseline; FAS, LOCF. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively.||score on a scale||Standard Deviation|Mean
159780|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Efficacy|Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
159781|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics|Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
159782|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on scale||Standard Deviation|Mean
159869|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159783|NCT00292188|Secondary|Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication|Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.|Screening, Week 8|FAS, LOCF. Number of subjects with evaluable data (n=pregabalin, placebo), respectively.||score on a scale||Standard Deviation|Mean
159784|NCT00292188|Secondary|Clinical Global Impression of Change (CGIC)|Clinical Global Impression of Change (CGIC): clinician’s judgment of overall change in the patient’s condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF||participants|||Number
159785|NCT00292188|Secondary|Patient Global Impression of Change (PGIC)|Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient’s overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.|Week 8|FAS, LOCF||participants|||Number
159786|NCT00292188|Secondary|Medical Outcome Study (MOS) Optimal Sleep|Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.|Week 8|FAS, LOCF.||participants|||Number
159787|NCT00292188|Secondary|Medical Outcome Study (MOS) Sleep Subscales|Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.|Week 8|FAS, LOCF. Number of subjects with evaluable data (n = pregabalin, placebo), respectively.||score on a scale||Standard Error|Least Squares Mean
159788|NCT00292188|Secondary|Weekly Mean Sleep Interference Score|11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.|Week 8|FAS, LOCF||score on scale||Standard Error|Least Squares Mean
159789|NCT00292188|Secondary|Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)|Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.|Baseline, Week 8|FAS, LOCF.||participants|||Number
159790|NCT00292188|Secondary|Weekly Mean Pain Score From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.|Baseline through Week 8|FAS. Number of subjects with evaluable data: (n = pregabalin, placebo), respectively||score on scale||Standard Error|Least Squares Mean
159791|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|Subset of subjects from the FAS who had moderate/severe baseline depression scores. LOCF.||score on scale||Standard Error|Least Squares Mean
159792|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.|Week 8|Subset of subjects from the FAS who had moderate/severe baseline anxiety scores. LOCF.||score on scale||Standard Error|Least Squares Mean
159793|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Depression Score|Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (“lowering of hedonic tone”). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|FAS LOCF||score on scale||Standard Error|Least Squares Mean
159794|NCT00292188|Secondary|Hospital Anxiety and Depression Scale (HADS) Anxiety Score|Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|Full analysis set (FAS), last observation carried forward (LOCF)||score on scale||Standard Error|Least Squares Mean
159795|NCT00292188|Primary|Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary|Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.|each day of Week 8|Full Analysis Set (FAS): all randomized subjects who received >= 1 dose study drug & have post-randomization efficacy data. Last Observation Carried Forward (LOCF).||score on a scale||Standard Error|Least Squares Mean
159796|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at 6 Months|Plasma B-type Natriuretic Peptide (BNP)|6 months|||picograms per millilitre||Standard Deviation|Mean
159797|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP) at Baseline|Plasma B-type Natriuretic Peptide (BNP) measured at basline|Baseline|||picograms per millilitre||Standard Deviation|Mean
159798|NCT00292162|Primary|Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months|Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months|6 months|||percentage of blood ejected in one beat||Standard Deviation|Mean
160895|NCT00282087|Secondary|Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)|AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only|2 years|||participants|||Number
159800|NCT00292162|Secondary|Plasma B-type Natriuretic Peptide (BNP)|venous blood taken to assess levels of the above peptide. High evels of the peptide are associated with adverse prognosis. Blood levels are taken at baseline and 6 months. The change over 6 months is assessed, thereore it is possible to have a negative number if the level falls.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate a blood test or dropped out of the study||picograms per millilitre||Standard Deviation|Mean
159801|NCT00292162|Primary|Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%|left ventricular ejection fraction (LVEF) is a measure of the % of blood ejected from the ventricle in one heart beat. It is a measure of cardiac function. We measured LVEF at baseline and at 6 months, to assess whether there had been a change in the patients cardiac function over time.|baseline and 6 months|Number of patients analyzed is different from number of patients enrolled because some of the outcomes could not be measured in some patients ie the patient did not tolerate an mri or dropped out of the study||percentage of blood ejected in one beat||Standard Deviation|Mean
159802|NCT00291694|Secondary|Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3|Change ion ratio.|baseline to 12 months|||ratio||Standard Error|Median
159803|NCT00291694|Secondary|Serum Sex Hormone Binding Globulin (SHBG) Concentration|Change in serum concentration|Baseline to 12 months|||nmol/L||Standard Error|Median
159804|NCT00291694|Secondary|Serum Estradiol Concentration|Change in serum estradiol concentration|Baseline to 12 months|||pg/ml||Standard Error|Median
159805|NCT00291694|Secondary|Mammographic Breast Density|The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.|Baseline and 12 months|Subjects completing 12 months, with baseline and 12 month mammograms suitable for density analysis, such that a change in density over time can be computed||percentage of breast area at increased d||Standard Error|Median
159806|NCT00291694|Primary|Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67|Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.|Baseline and 12 months|||percentage of cells staining positive||Full Range|Median
159807|NCT00291655|Secondary|Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months||Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months|Subjects with a discontinuation visit||kg||Standard Deviation|Mean
159808|NCT00291655|Primary|Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase|Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).|during open-label therapy phase of 18 months|Safety population that includes all subjects that have been treated once.||participants|||Number
159809|NCT00291577|Primary|Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters|Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||hours||Standard Deviation|Mean
159810|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
159811|NCT00291577|Primary|Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters|Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
159812|NCT00291577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters|Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose|Evaluable set of subjects for PK analysis||ng*hr.mL||Standard Deviation|Mean
159813|NCT00291577|Secondary|Duration of Tumor Response Based on Investigator Assessment|Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.|Start of first confirmed CR or PR to first confirmed progression or death|ITT; subgroup of subjects with objective disease response||weeks||95% Confidence Interval|Median
159814|NCT00291577|Secondary|Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment|Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study.|First dose of study treatment until at least 24 weeks on study|ITT; subjects with baseline assessments||participants|||Number
159815|NCT00291577|Secondary|Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment|Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|First dose of study treatment until at least 4 weeks after confirmed response or partial response|ITT; subjects with baseline assessments||participants|||Number
159816|NCT00291577|Secondary|Progression-Free Survival (PFS) Based on Investigator Assessment|Median time (50 percent [%]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7.|First dose of study treatment until progressive disease|ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).||weeks||95% Confidence Interval|Median
160896|NCT00282087|Secondary|Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)||2 years|||participants|||Number
159820|NCT00291577|Primary|Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.|0 hour postdose|Evaluable set of subjects for PK analysis; (n) = Number of observations above lower limit of quantification (NALQ). No participants analyzed for SU011248 C1D2 and SU012662 C1D2; standard deviation for Total drug C1D2 confirmed as 0.00 (median, minimum, and maximum = 0.20).||ng/mL||Standard Deviation|Mean
159821|NCT00291577|Primary|Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
159822|NCT00291577|Primary|Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis||ng*hr/mL||Standard Deviation|Mean
159823|NCT00291577|Primary|Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were > 5% of Cmax).|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis||ng/mL||Standard Deviation|Mean
159824|NCT00291577|Primary|Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters|Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.|1, 2, 4, 6, 8, 12, 24 hours postdose|Evaluable set of subjects for PK analysis is subjects in ITT population who completed sampling for PK profiles for both SU011248 and docetaxel; ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).||hours||Full Range|Median
159825|NCT00291551|Secondary|Number of Participants Who Died|Total number of patient deaths reported prior to study closure|Study duration|per protocol||participants|||Number
159826|NCT00291551|Secondary|Number of Adverse Events|Total adverse events reported prior to study closure|Study duration|per protocol||events|||Number
159827|NCT00291551|Secondary|Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score|The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death.|Baseline to 6 months|per protocol||score on a scale||Standard Deviation|Mean
159828|NCT00291551|Secondary|Changes in Cardiopulmonary Tests|Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months|Baseline to 6 months|per protocol||ml/kg/min||Standard Deviation|Mean
159829|NCT00291551|Secondary|Changes in 6 Minute Walk|Mean change in 6 minute walk distance (meters) between baseline and 6 months|Baseline to 6 months|per protocol||meters||Standard Deviation|Mean
159830|NCT00291551|Secondary|Change in Left Ventricular Mass|Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)|Baseline to 6 months|||grams||Standard Deviation|Mean
159831|NCT00291551|Secondary|Change in Left Ventricular Ejection Fraction|Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol||Percentage||Standard Deviation|Mean
159832|NCT00291551|Secondary|Changes in Left Ventricular Volumes|Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol||milliliters||Standard Deviation|Mean
159833|NCT00291551|Secondary|Changes in Left Ventricular Diameters|Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)|Baseline to 6 months|per protocol||centimeters||Standard Deviation|Mean
159834|NCT00291551|Secondary|Change in NYHA Functional Class|"Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remains the same as baseline. Improved means the participant's functional class has improved (become lower in number) by at least one class. Worsened means the participatn's functional class has deteriorated (become higher in number) by at least one class."|Baseline to 6 months|per protocol||participants|||Number
159835|NCT00291551|Secondary|Implant Success (Number of Participants Successfully Implanted)|"Implant success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position."|1 day|per protocol||participants|||Number
159836|NCT00291551|Primary|Death or Additional Surgical Session at 6 Months||6 months|Per protocol||participants|||Number
159837|NCT00291330|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
160897|NCT00282087|Secondary|Correlation Between Age and Tumor Response to Treatment (PFS)||2 years|||years||Full Range|Median
159838|NCT00291330|Secondary|Number of Participants With Acute Coronary Syndrome (ACS)|"Any ACS occurring during the conduct of the study (centrally adjudicated as definite).~Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|From first intake of study drug to end of study conduct|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
159839|NCT00291330|Secondary|Number of Participants With Bleeding Events|"Major bleeding events (MBE) were defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) was defined as~spontaneous skin hematoma >=25 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than spotting on toilet paper)~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug)|Treated set (TS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as treated.||participants|||Number
159840|NCT00291330|Secondary|Number of Participants Who Died (Any Cause)|Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
159841|NCT00291330|Secondary|Number of Participants Who Died Due to VTE|"VTE - related deaths which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
159842|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic Non-fatal PE|"Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
159843|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic DVT|"Symptomatic DVT which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||participants|||Number
159844|NCT00291330|Secondary|Number of Participants With Recurrent Symptomatic VTE and All Deaths|"VTE or any death which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee."|For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||Participants|||Number
159845|NCT00291330|Primary|Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE|All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.|For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)|Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.||Participants|||Number
159870|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159846|NCT00291317|Primary|Change in Bone Mineral Density Measured Via DEXA Scan|Bone mineral density (BMD) was measured with Dual X-ray Absorptiometry (DEXA) scans using a GE LUNAR system. DEXA has been used in patients with loss of ambulation due to SCI to monitor changes in body composition over time and to evaluate the effectiveness of exercise in preventing or reducing the disease-related complications of SCI. It was used in the present study to determine BMD in the right distal femur at baseline; after 3 months of intervention; after 6 months; and for children who biked for the full duration of the study, at the completion of 9 months of intervention.|At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)|||g/cm^2||Standard Deviation|Mean
159847|NCT00291317|Primary|Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.|The PedsQL™ 4.0 is a modular instrument for measuring health-related quality of life in children and adolescents. The questionnaire asks how much of a problem each item has been during the past month, using a 5-point response scale. This study used the Emotional Functioning, Social Functioning, and School Functioning modules. Scores on these three modules are combined to yield a Psychosocial Health Summary Score (range = 0-100 with 100 being the maximum positive outcome). Pre- and post-intervention scores were compared to determine improvement.|pre- and post-intervention; time frame among participants ranged from 4 to 12 months|Four of the six participants completed the PedsQL on at least 2 occasions. At minimum, each completed the PedsQL at their initial evaluation before beginning the cycling program and at or following their last cycling session.||units on a scale||Standard Deviation|Mean
159848|NCT00291226|Primary|Change in Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0–6, with 0–2 being the normal range, 3–5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Change from Baseline at 8 Weeks|||units on a scale||Standard Deviation|Mean
159849|NCT00291226|Primary|Scale of Prodromal Symptoms Total Score|Scale Of Prodromal Symptoms (SOPS) is a 19-item instrument. The SOPS is comprised of symptoms that are classified as falling into four pathology domains: positive, negative, disorganized and general. The scales identify and measure five attenuated positive psychotic symptoms, six negative symptoms, four disorganization symptoms and four general symptoms. These seven-point scales cover severity variance in the subpsychotic or attenuated range. Each item is scaled 0–6, with 0–2 being the normal range, 3–5 being the risk syndrome range, and 6 being severe and psychotic for the positive symptoms and very severe for the other symptoms. The higher the score, the more symptoms an individual has and is therefore negative in its interpretation. The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and can range from 0 to 114. Actual SOPS total scores in this study ranged from 23 to 59 across subjects at baseline.|Baseline|||units on a scale||Standard Deviation|Mean
159850|NCT00291187|Post-Hoc|Average Improvement in Latency to Non-awake (LNA)|The average improvement in latency to non-awake (length of time elapsed between lights off and first epoch of sleep determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||Minutes||Standard Error|Mean
159851|NCT00291187|Post-Hoc|Average Improvement in Total Sleep Time (TST)|The average improvement in Total sleep time (determined by PSG and defined as the number of non-wake minutes between lights off and lights on) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||Minutes||Standard Error|Mean
159852|NCT00291187|Secondary|Average Improvement of Wake After Sleep Onset (WASO)|The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||minutes||Standard Error|Mean
159853|NCT00291187|Primary|Average Improvement of Latency to Persistent Sleep (LPS)|The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.|Night 1|Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.||minutes||Standard Error|Mean
159854|NCT00291161|Primary|Veteran Outcomes|The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).|Baseline - six months|Data were collected for veterans who could be interviewed only.||units on a scale||Standard Deviation|Mean
159871|NCT00289783|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159855|NCT00291161|Primary|Caregiver Outcomes|The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)|Baseline and at six months|Data were collected for caregivers only||units on a scale||Standard Deviation|Mean
159856|NCT00291135|Primary|Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.|Proliferation assessment by immunocytochemistry using Ki-67. Expressed as percent of cells staining positive for Ki-67.|Baseline, 6 months|All subjects completed study and were used for analysis||Change in % of cells positive for Ki-67||Full Range|Median
159857|NCT00289848|Secondary|Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18|Change from baseline at Week 18 is defined as Week 18 minus Week 0.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
159858|NCT00289848|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18|Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.||mg/dL||95% Confidence Interval|Least Squares Mean
159859|NCT00289848|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18|A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Baseline and Week 18|The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.||Percent||95% Confidence Interval|Least Squares Mean
159860|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159861|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159862|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits|physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159863|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159864|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.|physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159865|NCT00289783|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159866|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159867|NCT00289783|Secondary|Number of Subjects Reporting Rash|Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.|From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159868|NCT00289783|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|From the fourth dose through the end of the 6-month safety follow-up|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
161346|NCT00275561|Secondary|Number of Participants With Complete Histologic Response|A complete histologic response was defined as >90% decrease in mean eosinophil count/high powered field|2 weeks|Analysis was run per protocol.||participants|||Number
159872|NCT00289783|Secondary|Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination|Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within 43 days (Day 0 through Day 42) after vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159873|NCT00289783|Secondary|Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)|Increased circumferential swelling defined as either swelling with a diameter of >50 mm or a >50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0 to Day 3) after fourth dose vaccination|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159874|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159875|NCT00289783|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Day 0-30) following the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159876|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C|Within the 4 days (Day 0-3) post-vaccination period following the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159877|NCT00289783|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.|Within the 4 days (Day 0-3) following the primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159878|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day0-3) follow-up period after the fourth dose|The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.||Subjects|||Number
159879|NCT00289783|Secondary|Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit|Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).|In the 4-day (Day 0-3) follow-up period after primary vaccination course|The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 & Cohort 3) in the primary phase.||Subjects|||Number
159880|NCT00289783|Secondary|Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40|"anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based."|Prior to the fourth dose vaccination and one month after the fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159881|NCT00289783|Secondary|Anti-varicella Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||Titers||95% Confidence Interval|Geometric Mean
159882|NCT00289783|Secondary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:40|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||Subjects|||Number
159883|NCT00289783|Secondary|Anti-rubella Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||IU/mL||95% Confidence Interval|Geometric Mean
162172|NCT00265317|Secondary|Plasma Concentration of VEGF-C at Baseline||Baseline (Cycle 1, Day 1)|FA Set||picograms (pg)/mL||Full Range|Median
159884|NCT00289783|Secondary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010||Subjects|||Number
159885|NCT00289783|Secondary|Anti-mumps Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Titers||95% Confidence Interval|Geometric Mean
159886|NCT00289783|Secondary|Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values|"Anti-mumps antibody cut-off values assessed were >=28 estimated dose 50 (ED50) and >=51 ED50.~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
159887|NCT00289783|Secondary|Anti-measles Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL).~The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||mIU/mL||95% Confidence Interval|Geometric Mean
159888|NCT00289783|Secondary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|42 days after fourth vaccination|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
159889|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159890|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
159891|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|Prior to the fourth dose vaccination and 42 days after fourth vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159892|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
159893|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159894|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|"hSBA-MenC and hSBA-MenY antibody cut-off values assessed were >=1:4 and >=1:8.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria ) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose||Subjects|||Number
159895|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course and prior to the fourth dose vaccination|The Fourth dose ATP cohort for safety included eligible subjects, who met inclusion criteria, who received 3 vaccine doses in the primary vaccination course, who received the fourth vaccine dose, who did not receive a vaccine not specified or forbidden and who were not excluded from from the Primary ATP cohort for immunogenicity.||µg/mL||95% Confidence Interval|Geometric Mean
159896|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value|"Anti-PRP antibody cut-off values assessed were >=0.15 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose.||Subjects|||Number
159897|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
159898|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibodies Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
159899|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159900|NCT00289783|Secondary|Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159901|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
159919|NCT00289783|Primary|Number of Subjects With Anti-varicella Titer Equal to or Above 1:5|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5.~Co-administration with Varivax vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
162224|NCT00265317|Secondary|Cmax of Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||ng/mL||Standard Deviation|Mean
159902|NCT00289783|Secondary|hSBA-MenC and hSBA-MenY Antibody Titers|"Titres are expressed as Geometric Mean Titers (GMTs).~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
159903|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159904|NCT00289783|Secondary|Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values|"hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159905|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
159906|NCT00289783|Secondary|Anti-PRP Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
159907|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and one month after fourth dose vaccination|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159908|NCT00289783|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values|"Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL.~The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis."|One month after the primary vaccination course|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159909|NCT00289783|Secondary|Anti-PSC and Anti-PSY Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||µg/mL||95% Confidence Interval|Geometric Mean
159920|NCT00289783|Primary|Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL.~Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
159910|NCT00289783|Secondary|Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values|"Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159911|NCT00289783|Secondary|Anti-poliovirus Types 1, 2 and 3 Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
159912|NCT00289783|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159913|NCT00289783|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||EL.U/mL||95% Confidence Interval|Geometric Mean
159914|NCT00289783|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159915|NCT00289783|Secondary|Anti-HBS Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL)~Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||mIU/mL||95% Confidence Interval|Geometric Mean
159916|NCT00289783|Secondary|Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)|"Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine.~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159917|NCT00289783|Secondary|Anti-D and Anti-T Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL).~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||IU/mL||95% Confidence Interval|Geometric Mean
159918|NCT00289783|Secondary|Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
160289|NCT00286728|Primary|Psychiatric Functioning at 6 Months|Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.|6 months|Explanation of Ns discrepant with patient flow: Ns with psychiatric severity scores at 6 months differ from those having completed the study at 2 years.||units on a scale||Standard Deviation|Mean
159921|NCT00289783|Primary|Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50~Co-administration with MMR-II vaccine."|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
159922|NCT00289783|Primary|Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)|"The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL.~Co-administration with MMR-II vaccine"|42 days after the fourth dose|The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.||Subjects|||Number
159923|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159924|NCT00289783|Primary|Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159925|NCT00289783|Primary|Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Subjects|||Number
159926|NCT00289783|Primary|Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)|This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Subjects|||Number
159927|NCT00289783|Primary|hSBA-MenY Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
159928|NCT00289783|Primary|hSBA-MenC Antibody Titers|"Titers are expressed as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|Prior to the fourth dose vaccination and 42 days after the fourth dose|The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.||Titers||95% Confidence Interval|Geometric Mean
159929|NCT00289783|Primary|Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers are expressen as Geometric Mean Titers (GMTs)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
159930|NCT00289783|Primary|Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers|"Titers were expressed as Geometric Mean Titers (GMTs)~This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||Titers||95% Confidence Interval|Geometric Mean
159941|NCT00289757|Primary|Number of Seropositive Subjects for Anti-HAV Antibodies.|"Seropositivity for anti-HAV antibodies defined as antibody concentrations ≥ 15 mIU/mL for Year 11 to Year 20 time points.~The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|From Year 11 to Year 20|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.||Subjects|||Number
159931|NCT00289783|Primary|Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations|"Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL)~This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis."|One month after primary vaccination|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
159932|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|up to Year 11, 12, 13, 14, 15|Analysis was performed on the long-term (LT) Total Vaccinated Cohort, this included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling time-point and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
159933|NCT00289770|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
159934|NCT00289770|Primary|Number of Subjects With Unsolicited Symptoms|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional Engerix vaccination|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
159935|NCT00289770|Primary|Number of Subjects With Solicited Local and General Symptoms Assessed|Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, fever, gastrointestinal, headache.|During the 4-day follow-up period after additional vaccination with Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
159936|NCT00289770|Primary|Number of Subjects, Receiving an Additional Vaccination of Engerix, With an Anamnestic Response|"Anamnestic response was assessed in subjects receiving an additional vaccine dose of Engerix. Two subjects were found eligible at Year 11 for this additional vaccine dose.~Anamnestic response was defined as:~post-additional vaccination anti-HBs concentration >= 10 mIU/mL in subject seronegative before additional dose.~4-fold increase post-additional dose compared to pre-additional vaccine time point."|30 days post additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||subjects|||Number
159937|NCT00289770|Primary|Anti-HBs Antibody Concentrations|"Subjects who lost seroprotective concentrations for anti-HBs (< 10 mIU/mL) at any of the LT follow-up timepoints received an additional dose of Engerix after year 15.~Two subjects were eligible for this after Year 11.~3.29 in the table means a concentration of < 3.3 mIU/mL.~As the concentration was calculated per subject no mean concentration was calculated and also no measure of dispersion."|at Year 11, pre-additional vaccine, after additional dose of Engerix|Analysis was performed on the long-term (LT) Total Vaccinated Cohort in subjects who were eligible for an additional dose. This included all subjects who had received at least one dose of the study vaccine in the primary study and who returned for the blood sampling timepoint and who had serology results for anti-HAV and anti-HBs available.||mIU/mL|||Number
159938|NCT00289770|Primary|Anti-HAV and Anti-HBs Antibody Concentrations|"Concentrations are expressed as geometric mean concentrations (GMCs) in mIU/mL.~The laboratory assay was changed from Year 13 to Year 14 to in-house ELISA and at Year 15 to CLIA for anti-HBs GMCs.Thus for the sake of bridging, blood samples corresponding to Year 14 previously tested with ELISA were re-tested with CLIA (Year 14*)."|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.||mIU/mL||95% Confidence Interval|Geometric Mean
159939|NCT00289770|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values were defined 3.3 mIU/mL for the in-house anti-HBs assay and 6.2 mIU/mL for the ChemiLuminescence ImmunoAssay, which was also considered as seropositivity, and 10 mIU/mL.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.||subjects|||Number
159940|NCT00289770|Primary|Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value|Cut-off value was defined as 15 milli-international units per milliliter (mIU/mL). This was considered as seropositivity.|Years 11, 12, 13, 14 and 15|Analysis was performed on the long-term (LT) According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who returned at a particular blood sampling timepoint, were in the ATP immunogenicity cohort in the primary study and for whom serology results were available for that particular timepoint.||subjects|||Number
159942|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the follow-up period after additional vaccination up to Year 20|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
159943|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Grade AE = produced significant impairment of functioning or incapacitation and was a definite hazard to the subject's health.~Related AE = assessed by the investigator as related to the study vaccination."|During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
159944|NCT00289757|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed included fatigue, fever, gastrointestinal symptoms, and headache.|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
159945|NCT00289757|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain = symptom that prevented normal activities. Grade 3 redness and swelling = redness or swelling above 30 mm and persisting more than 24 hours.~Any = incidence of a particular symptom regardless of intensity."|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||Subjects|||Number
159946|NCT00289757|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term Total cohort which included all subjects who returned to the follow-up study and who had received at least 1 dose of the vaccine in the primary study.||Subjects|||Number
159947|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL.|Before the additional dose, 14 days and 30 days after the additional dose|Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.||mIU/mL|||Number
159948|NCT00289757|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).~The laboratory assay was changed at Year 11, thus the blood samples were with both the old and the new assay for the sake of bridging."|At Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the 2-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint.||mIU/mL||95% Confidence Interval|Geometric Mean
159949|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
159950|NCT00289744|Primary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
159951|NCT00289744|Primary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gatrointestinal symptoms and headache.|During the 4-day follow-up period after additional dose|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
159952|NCT00289744|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy|Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|At Year 6, 7, 8, 9 and 10|The analysis was performed on the long-term (LT) total vaccinated cohort.||subjects|||Number
159971|NCT00290810|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate distributions in the B-CLL population.|From the date of registration to the date of the event (i.e., death or the date of last follow-up), up to 5 years.|||months||95% Confidence Interval|Median
161423|NCT00274287|Secondary|These Include Response Rate (RR), Overall Survival (OS), Toxicity and Safety of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), and Time to Requiring Additional Systemic Chemotherapy (TTRC)||time events happen||||||
159953|NCT00289744|Primary|Number of Subjects With Immune Response to the Additional Dose of Engerix™-B|"Immune response was defined as:~anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points~at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.||subjects|||Number
159954|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||Before and 1 month after the additional dose administration|The analysis was performed on the total vaccinated cohort for the additional dose.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
159955|NCT00289744|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration||At Year 6, 7, 8, 9 and 10|The analysis was performed on the total vaccinated cohort for the additional dose.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
159956|NCT00289744|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration||Years 6, 7, 8, 9, and 10.|The analysis was performed on the total vaccinated cohort for the additional dose.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
159957|NCT00289718|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|During the follow-up period after additional vaccination (minimum 30 days)|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
159958|NCT00289718|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 30-day follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
159959|NCT00289718|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
159960|NCT00289718|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During the 4-day (Day 0-3) follow-up period after additional vaccination|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose.||subjects|||Number
159961|NCT00289718|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above|Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|||subjects|||Number
159962|NCT00289718|Secondary|Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|"If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.~Only 1 subject was offered an additional dose and therefore the values obtained for this subject have been provided. Because only 1 subject was included it was not possible to provide a mean/median and a measure of dispersion."|Before the additional dose and 1 month after the additional dose|Analysis was performed on the Long Term Total cohort, on subjects who received an additional vaccine dose. Only 1 subject received an additional dose.||mIU/mL|||Number
159963|NCT00289718|Secondary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|"Concentrations given as GMC expressed as mIU/mL.~If a subject became seronegative (< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose."|Before the additional dose and 1 month after the additional dose||||||
159964|NCT00289718|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration|Concentrations given as GMC expressed as mIU/mL.|Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint||mIU/mL||95% Confidence Interval|Geometric Mean
159965|NCT00289718|Primary|Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration|Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).|Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination|Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity, on subjects with available data for the defined timepoint||mIU/mL||95% Confidence Interval|Geometric Mean
159966|NCT00290888|Secondary|Upper Extremity Strength Grading||24 months||||||
159967|NCT00290888|Secondary|Shoulder Range of Motion||24 months||||||
159968|NCT00290888|Primary|American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)|Calculated as a percentage with an increase in score reflecting an improvement in outcome.|24 months|||percentage of total score||Standard Deviation|Mean
159969|NCT00290888|Primary|Western Ontario Rotator Cuff Index (WORC)|Calculated as percentage with an increase in score indicating an improvement in outcome.|24 months|||percentage of total score||Standard Deviation|Mean
159970|NCT00290810|Secondary|Time to Progression|"Progression is defined as one of the following:~A ≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥2 cm) or the appearance of new palpable lymph nodes, or~A ≥50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or the appearance of hepatomegaly or splenomegaly which was not previously present, or~The transformation to a more aggressive histology (e.g. Richter’s transformation), or~A ≥ 50% increase in the absolute number of circulating lymphocytes.~The Kaplan-Meier method will be used to estimate time to progression."|From the date of registration to the date of the event (i.e., death or disease progression) or the date of last follow-up, up to 5 years|||months||95% Confidence Interval|Median
159972|NCT00290810|Secondary|Toxicity Associated With This Regimen in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).|As per NCI Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The number of participants experiencing grade 3 or higher toxicity will be reported here.|From the date of registration to the to the date of last treatment evaluation, median number of days on treatment was 56 days.|All 12 participants treated will be used to analyze this endpoint.||participants|||Number
159973|NCT00290810|Primary|Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).|"The NCI Working Group criteria will be used to assess response to therapy. A confirmed response is defined as a response documented on 2 consecutive evaluations at least 4 weeks apart.~Complete Response:~No lymphadenopathy~No hepatomegaly or splenomegaly~Absense of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets > 100,000/ul~Hemoglobin > 11.0 gm/dl~Peripheral blood lymphocytes ≤ 4000/uL.~Confirmation by Marrow Aspirate and biopsy.~Complete Clinical Response:~-CR without bone marrow biopsy confirmation.~Nodular Partial Response:~-CR with the presence of residual clonal nodules.~Partial Response requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul~Hemoglobin >11.0 gm/dl"|Up to 5 years|All 12 patients are used in this analysis||participants|||Number
159974|NCT00290771|Secondary|Number of Patients With at Least 1 Adverse Event|An adverse event (AE) is any undesirable sign, symptom, or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. Study drug refers to imatinib or hydroxyurea. The study treatment is the combination of these two study drugs.|Baseline to end of study (Month 24)|Safety population: All patients who received at least 1 dose of either of the 2 study drugs and who had at least 1 post-baseline safety assessment.||Participants|||Number
159975|NCT00290771|Secondary|Percentage of Patients Surviving at Months 6, 12, and 24|Patients not known to have died were censored at the time of last survival follow-up.|Months 6, 12, and 24|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
159976|NCT00290771|Secondary|Percentage of Patients With Progression-free Survival at Months 6 and 12|Progression-free survival (PFS) was defined as the time from the start of treatment to the date of the first documented disease progression (PD) or death due to any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, progression-free survival was censored at the time of the last overall response assessment.|Months 6 and 12|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
159977|NCT00290771|Secondary|Percentage of Patients Who Had Clinical Benefit|Patients who had clinical benefit were patients with a best response of complete response (CR), partial response (PR), or stable disease (SD) lasting for more than 6 months from the start of treatment until the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. SD was defined as insufficient tumor shrinkage to qualify for PR or CR and no increase in lesions which would qualify as PD.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
159978|NCT00290771|Secondary|Duration of Objective Overall Response (OOR)|Duration of OOR only included patients whose best overall response was complete response (CR) or partial response (PR). The start date was the date of the first documented response (CR or PR); the end date was the date of the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, the duration of OOR was censored at the time of the last OOR assessment.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Weeks||95% Confidence Interval|Median
159979|NCT00290771|Primary|Percentage of Patients With an Objective Overall Response (OOR)|Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR required at least 2 determinations of PR or better at least 4 weeks apart (and not qualifying for CR).|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs.||Percentage of participants||95% Confidence Interval|Number
159980|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): ps2|Mean change in concentration of protein ps2 measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 month - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in ps2 concentration available for 44 participants. Analysis performed by menopause and cancer status.||ng/ml||Standard Deviation|Mean
159981|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Cathepsin D|Mean change in concentration of Cathepsin D measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in Cathespin D concentration available for 44 participants. Analysis performed by menopause and cancer status.||mg/ml||Standard Deviation|Mean
159982|NCT00290758|Secondary|Plasma Concentration of Sex Hormone Binding Globulin (SHBG)||6 months - baseline|Plasma concentration of SHBG was not available for 1 patient in Arm A. Analysis performed by menopause and cancer status.||nmol/L||Standard Deviation|Mean
161643|NCT00271544|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
159983|NCT00290758|Secondary|Monitor Drug Delivery by Measuring Plasma Genistein by HPLC|Drug delivery is measured be concentration of genistein in plasma using High Performance Liquid Chromatography (HPLC). Mean change in concentration of plasma genistein is assessed from baseline to 6 month follow up.|6 months - baseline|Analysis performed by menopause and cancer status.||ng/ml||Standard Deviation|Median
159984|NCT00290758|Secondary|Breast Endocrine Environment Measured in Nipple Aspiration Fluid (NAF): Estradiol|Mean change in concentration of estradiol measured in nipple aspiration fluid assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in estradiol concentration available for 40 participants. Analysis performed by menopause and cancer status.||pg/ml||Standard Deviation|Mean
159985|NCT00290758|Secondary|Change in Cytomorphologic Assessment of Atypia and Spectral Imaging Analysis of Atypica Features in Epithelial Cells.|"Cytologic atypia evaluation was performed on Papanicolau stained Thin Prep slides using standard criteria, which were also used for spectral spatial imaging. Cell clusters were used to generate image stacks with the Nuance LCTF-based imaging system (CRI Inc). The image data was collected as percent pixels assigned as “atypical”. Mean change in the percent pixels assigned atypical is assessed from baseline to 6 month follow up."|6 months - baseline|Analysis performed by menopause and cancer status.||Percent pixels||Standard Deviation|Mean
159986|NCT00290758|Secondary|Measurement of Change in Concentration of Epidermal Growth Factor (EGF) Found in Nipple Aspirate Fluid (NAF)|Mean change in the concentration of EGF found in nipple aspirate fluid is assessed from baseline to 6 month follow up.|6 months - baseline|NAF collection was attempted on all 98 participants and was successful in 46 at both time points. Mean change in EGF concentration available for 43 participants. Analysis performed by menopause and cancer status.||ng/ml||Standard Deviation|Mean
159987|NCT00290758|Primary|Change in Breast Epithelial Cell Proliferation as Measured by Ki-67 Labeling|Breast epithelial tissue samples are used to measure the expression of the cell proliferation marker Ki-67, by counting the percentage of positive MIB-1 immunostained cells, denoted the Ki-67 labeling index. Mean change in the Ki-67 labeling index is assessed from baseline to 6 month follow up.|6 months - baseline|Participants who had more than 4,000 epithelial cells in rFNA samples at both baseline and 6 month follow up, met the criteria for compliance, and were available for evaluation of Ki-67 labeling index at both time points. Analysis performed by menopause and cancer status.||Ki-67 labeling index||Standard Deviation|Mean
159988|NCT00290732|Secondary|Concentrations of Doxorubicin in Tissue at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in tissue across all the participants in each group is reported.|Day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.||nmol/g|||Number
159989|NCT00290732|Secondary|Concentrations of Doxorubicin in Blood (Plasma) at Definitive Surgery|Due to the limited number of samples and detectable levels, the maximum concentration of doxorubicin in blood (plasma) across all the participants in each group is reported.|Baseline, 4 hrs, day2/24 hrs, day 8, day of surgery/biopsy|Participants in whom blood and/or tissue samples were collected at surgery or breast biopsy.||nM|||Number
159990|NCT00290732|Primary|Maximum Tolerated Dose (MTD)|Maximum tolerated dose (MTD) of administering pegylated liposomal doxorubicin (PLD) into one duct of women with breast cancer awaiting mastectomy. MTD reflects highest dose of drug that did not cause Dose Limiting Toxicity (DLT) in more than 30% of patients.|Until up to 30 days after PLD administration|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.||milligrams|||Number
159991|NCT00290693|Primary|Number of Participants Achieving a 50% or More Reduction in CA 19-9 Levels|Number of participants achieving a 50% or more reduction in CA 19-9 levels after receiving protocol therapy. Baseline CA-19-9 will be compared to the lowest recorded value on patients receiving therapy on protocol. A 50% drop in CA 19-9 in patients with baseline levels above 100 U/ml will be recorded as a CA 19-9 response if the > 50% drop can be confirmed with at least one more CA 19-9 level thereafter with > 50% drop compared to baseline.|1 year|||participants|||Number
159992|NCT00290693|Secondary|Toxicity as Collected Through Protocol Execution||1 year||||||
159993|NCT00290693|Secondary|Time to Progression as Measured by the Kaplan Meyer Curve||1 year||||||
159994|NCT00290693|Primary|Number of Participant Achieving Complete Response or Partial Response to Therapy.|Number of participants achieving complete response (CR) or partial response (PR) to Captere therapy according to RECIST criteria v 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|1 year|||participants|||Number
159995|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|12 months after treatment|||percentage of participants|||Number
159996|NCT00290654|Secondary|Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|6 months after treatment|||percentage of participants|||Number
159997|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|12 months after treatment|||percentage of physicians|||Number
162225|NCT00265317|Secondary|Maximum Observed Plasma Concentration (Cmax) of Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A||mcg/mL||Standard Deviation|Mean
159998|NCT00290654|Secondary|Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent|The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: “0” representing an excellent result; “1” a good result; “2” a fair result; and “3” a poor result.|6 months after treatment|||percentage of physicians|||Number
159999|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|more than 6 months after treatment, for up to 5 years|||percentage of participants|||Number
160000|NCT00290654|Secondary|Percentage of Patients Who Experienced Complications|Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.|within 6 months of treatment|||percentage of participants|||Number
160001|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|5 years after treatment|||participants|||Number
160002|NCT00290654|Primary|Number of Patients With Ipsilateral Breast Tumor Recurrence|Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.|1 year after treatment|||participants|||Number
160003|NCT00290615|Secondary|Overall Survival|Average months of survival of participants after receiving study drug.|From time of treatment until death from any cause, assesed up to 60 months.|||months||95% Confidence Interval|Median
160004|NCT00290615|Other Pre-specified|Effect on Wound Angiogenesis||After study completion||||||
160005|NCT00290615|Other Pre-specified|Effect on Angiogenesis Biomarkers||After study completion||||||
160006|NCT00290615|Secondary|Progression-free Survival|"Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~This is the average number of months participants survived without showing progressive disease."|From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.|||months||95% Confidence Interval|Median
160007|NCT00290615|Secondary|Safety and Tolerability|Number of participants with adverse events|After all participants went off study drug regimine.|||participants with adverse event|||Number
160008|NCT00290615|Primary|Response Rate (Percentage of Participants With Partial or Complete Response)|"Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression.~Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines.~The definitions were:~Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.|All subjects who received restaging scans were analyzed.||percentage of participants with response||95% Confidence Interval|Number
160009|NCT00290537|Primary|Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)|Evaluate the response rate in patients receiving monotherapy with ZD6474 compared to ZD6474 plus carboplatin plus paclitaxel. No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfil the recruitment target.|Radiologic evaluations performed after weeks 2 and 9 of treatment, then every 2 cycles or as indicated if progressive disease is suspected up to 6 cycles or 18 weeks (1 cycle = 3 weeks).|||Participants|||Number
160010|NCT00290472|Primary|Overall Survival|The overall survival was evaluated using the Kaplan-Meier estimator.|Up to 6 years|||Month||95% Confidence Interval|Median
160011|NCT00290472|Primary|Duration of Response|Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|Up to 6 years|||Month||95% Confidence Interval|Median
160012|NCT00290472|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|Up to 6 years|||percentage of participants|||Number
160013|NCT00290407|Secondary|Blood Specimens Will be Collected to Measure Immunologic Effect||at weeks 4, 8, 12, and at month 6||||||
160014|NCT00290407|Primary|CT Scan to Measure Clinical Effect (Response)|Study terminated, results data not available|3 months after starting treatment, 6 months after starting treatment, and every 6 months (after completing treatment) until disease progression||||||
160096|NCT00289536|Secondary|Total Area Under the Moment Curve|Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour^2/dL||Full Range|Median
163844|NCT00243919|Primary|Walking Speed: Measured During a 10-meter Walk||Baseline and 12 months post-stroke|||m/sec||Standard Deviation|Mean
160015|NCT00290290|Primary|The Primary Objective of This Trial is to Compare the Impact of Disinfecting the Skin With Chloraprep vs. Betadine on the Rates of Infection of Clean-contaminated Surgical Wounds.|The primary end point of the study was the occurrence of any surgical-site infection. Diagnosis of surgical-site infection was diagnosed by a blinded reviewer following criteria developed by the Center for Disease Control. The significance of difference between the two study groups in terms of patient characteristics was determined with the use of the Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables. For efficacy outcomes, we compared the proportions of patients in the two study groups who could be evaluated and who any type of surgical-site infection using Fisher's exact test and calculating the relative risk of infection and 95% confidence intervals. To determine whether the results were consistent across the 6 participating hospitals, a prespecified Breslow-Day test for homogeneity was performed.|during surgery and within the 30 days post surgery|||Percentage of Post Operative Infections|||Number
160016|NCT00290251|Secondary|Quality of Life|The short form-36 (SF-36)and Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaires were given before and at treatment end with scales of 0 - 100. SF-36 scales = mental and physical well-being. The UFS subscales are symptom severity, concern, activities, energy and mood, control, self-consciousness, sexual functioning compiled into an overall QOL score. Higher results indicate better QOL on all but symptom severity (higher = worse). The change in scores from baseline to end of treatment was calculated.|3 months (Baseline to end of treatment 1)|All completers received a questionnaire at the end of the three-month study. One woman in the placebo group did not complete the questionnaire.||units on a scale||Standard Error|Mean
160017|NCT00290251|Primary|Shrinkage of Fibroids - Size of Fibroids|The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.|3 months (baseline to end of treatment)|Per protocol, including women with two MRIs regardless of whether they took all study medication||logcm3||Standard Error|Mean
160018|NCT00290238|Secondary|Total Expenditure Per Day on All Lower Back Pain Related Interventions|Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers’ Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.|Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12|Analysis population was intention to treat (ITT).||Dollars||Full Range|Median
160019|NCT00290238|Primary|Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score|"Visual analog scale (VAS) for pain (100mm line with 0/No pain on the left and 100/Worst pain imaginable on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits."|Time-averaged from the first available observation to the last available observation (12 months for completed subjects)|Analysis population was intention to treat (ITT), excluding subjects who had no follow-up (after the initial 10-week treatment phase) data available.||mm||Standard Error|Least Squares Mean
160020|NCT00290199|Secondary|Induction to Vaginal Delivery Interval|Mean hours from time of induction to vaginal delivery interval.|time from induction to vaginal delivery, up to 24 hours|||hours||Standard Deviation|Mean
160021|NCT00290199|Secondary|Cesarean Rate|The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.|at delivery|||percentage of subjects|||Number
160022|NCT00290199|Secondary|Rate of Delivery (Vaginal or Cesarean)by 24 Hours|The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.|from start of induction to 24 hours post start of induction|||percentage of deliveries|||Number
160023|NCT00290199|Primary|Hours From Placement of Foley or Initiation of Oxytocin to Delivery (up to 24 Hours)|The outcome measure is the mean in hours of the time from induction to delivery|Time from induction to delivery|||hours||Standard Deviation|Mean
160024|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time Variability in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the variability in processing time in milliseconds that it takes to correctly respond to a target. Response time variability = the standard deviation of response times for correct responses. Lower values represent less variability and better responses. Range of response times = 0-2000 milliseconds.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||time in milliseconds||95% Confidence Interval|Mean
160025|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Response Time in Milliseconds|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the processing time in milliseconds that it takes to correctly respond to a target. Lower times represent better response times. Range = 0 - 2000 milliseconds|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||time in milliseconds||95% Confidence Interval|Mean
160097|NCT00289536|Secondary|Total Area Under the Curve|Total AUC with extrapolation using the slope of the β-phase|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour/dL||Full Range|Median
160026|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Nonresponses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly not selected (number of times a child correctly refrains from hitting a buzzer) when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct nonresponses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||Number of correct nonresponses||95% Confidence Interval|Mean
160027|NCT00290186|Secondary|The Difference Between Groups in Change in Scores (Post-treatment Minus Pre-treatment) on the Test of Variables of Attention (TOVA): Number of Correct Responses.|One of 4 parts of the TOVA, a computerized continuous performance test that measures attention and impulsivity in visual mode. Measures the number of times a target is correctly selected when it appears on a screen. Score ranges from 0-160; higher scores represent greater number of correct responses.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|The TOVA was only administered to patients who were 4-8 years old, not visually impaired, and able to complete a practice test. Analysis included all eligible participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||number of correct responses||95% Confidence Interval|Mean
160028|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Social Function|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 5 items of daily activity grouped under social function. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-25 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160029|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Mobility|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 7 items of daily activity grouped under mobilityare. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-35 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160030|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Caregiver Assistance: Self-care|Primary caregiver-reported (through structured interview) amount of caregiver assistance required by child to complete 8 items of daily activity grouped under self-care. Scores are 0 = total assistance, 1 = maximal assistance, 3 = minimal assistance, 4 = supervise/prompt/monitor, 5 = independent. Total scores range from 0-40 and are rescaled to 0-100%. Higher scores indicate greater ability to perform independently.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160031|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Social Function|Primary caregiver-reported (through structured interview) child capabilities for 65 items of functional skills grouped under social function. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-65 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160032|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Mobility|Primary caregiver-reported (through structured interview) child capabilities for 59 items of functional skills grouped under mobility. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-59 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160066|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms|Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160033|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Scores (Post-treatment Minus Pre-treatment) on Pediatric Evaluation of Disability Inventory (PEDI) Functional Skills: Self-care|Primary caregiver-reported (through structured interview) child capabilities for 73 items of functional skills grouped under self-care. Scores are 0 = unable to perform; 1 = capable of performing. Scores range from 0-73 and are rescaled to a 0-100% scale. Higher scores indicate greater abilities.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160034|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension E|Total percent score on 24 items of GMFM grouped into Dimension E) walking, running, and jumping. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension E determined by dividing score obtained by maximum possible score for that dimension (72), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. E) walking, running, and jumping: (score achieved/72)x 100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160035|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D|Total percent score on 13 items of GMFM grouped into Dimension D) standing. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension D determined by dividing score obtained by maximum possible score for that dimension (39), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. D) standing: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160036|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C|Total percent score on 14 items of GMFM grouped into Dimension C) crawling and kneeling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension C determined by dividing score obtained by maximum possible score for that dimension (42), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. C) crawling and kneeling: (score achieved/42)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160037|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B|Total percent score on 20 items of GMFM grouped into Dimension B) sitting. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension B determined by dividing score obtained by maximum possible score for that dimension (60), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. B) sitting: (score achieved/60)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160038|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A|Total percent score on 17 items of GMFM grouped into Dimension A) lying and rolling. Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score in Dimension A determined by dividing score obtained by maximum possible score for that dimension (51), and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. A) lying and rolling: (score achieved/51)x100.|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160039|NCT00290186|Secondary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure 66-Item Subscale Score (GMFM-66).|GMFM-66: total percent score on 66-item subscale of GMFM-88: Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Score determined by dividing score obtained by maximum possible score for the 66 items, and multiplying by 100. Range is 0-100%: the higher the percent score, the greater the functional ability. GMFM-66: [(total score on subset of 66 items/198)x100].|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160067|NCT00289900|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160040|NCT00290186|Primary|The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Total Score (GMFM-88).|"GMFM-88: total percent score on 88 items (I) of motor function grouped into 5 dimensions: A) lying and rolling (17 I), B) sitting (20 I), C) crawling and kneeling (14 I), D) standing (13 I), E) walking, running, jumping (24 I). Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Scores in each dimension determined by dividing score obtained by maximum possible score for that dimension, and multiplying by 100. Range is 0-100% for each: the higher the percent score, the greater the functional ability.~Dimension scores and total GMFM-88 score calculated as:~A) lying and rolling: (score achieved/51)x100 B) sitting: (score achieved/60)x100 C) crawling and kneeling: (score achieved/42)x100 D) standing: (score achieved/39)x100 E) walking, running, and jumping: (score achieved/72)x 100 GMFM-88 = (%A+%B+%C+%D+%E)/number of dimensions GMFM-66: [(total score on subset of 66 items/198)x100]"|Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)|Analysis included all participants who completed baseline assessments (within 1-week of start of treatment), 40 hyperbaric treatments, and post-treatment assessments (within 1 week of ending treatment).||units on a scale||95% Confidence Interval|Mean
160041|NCT00289991|Secondary|Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment|Percent of subjects who used other systemic antifungal agents as empirical or therapeutic treatment, defined as either empirical: subject took a systemic antifungal agent at any time after the day of first dose of medication and did not develop a breakthrough proven or probable IFI during the study or therapeutic: subject developed a breakthrough proven or probable IFI.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations. Subjects who developed a breakthrough proven or probable IFI were identified only from the study database, not the EORTC/MSG worksheet. In addition, all agents identified to be antifungals were considered to be systemic.||percent of participants|||Number
160042|NCT00289991|Secondary|Duration of Treatment|Median duration in days of treatment. Treatment is defined as the total number of days on which subjects took medication.|Day 1 up to Day 180|MITT; data from 1 site excluded due to GCP deviations.||days||Full Range|Median
160043|NCT00289991|Secondary|Survival: Percent of Subjects Who Died Within 1 Year|Percent of subjects who died within 1 year after transplant, derived from the crude death rate. All subjects in the MITT population included in this proportion. Only deaths up until and including 365 days after first dose of study medication included in the analysis.|Day 1 up to 1 year (Day 365)|MITT; data from 1 site excluded due to GCP deviations. Typically, subjects received first dose study treatment on the day of their transplant; however, some subjects started treatment up to 48 hours after transplant. Data summarized with first day of study medication defined as Day 1.||percent of participants|||Number
160044|NCT00289991|Secondary|Time to Discontinuation of Study Treatment|Time in days to discontinuation of study treatment defined as the number of days from first dose to last dose inclusive as recorded in the dosing log.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations.||days||95% Confidence Interval|Mean
160045|NCT00289991|Secondary|Survival: Percent of Subjects Who Died at or Before Day 180|Percent of subjects who died at or before Day 180, derived from the crude death rate. All subjects in the MITT population included in this proportion.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis does not include any deaths recorded in the long-term follow-up data (not available at time of analysis).||percent of participants|||Number
160046|NCT00289991|Secondary|Percent of Subjects With Occurrence of Breakthrough IFI|Percent of subjects with occurrence of breakthrough IFI (proven or probable). Included all subjects in the MITT population.|Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on EORTC/MSG worksheets (not on Case Report Forms or in the database).||percent of participants|||Number
160047|NCT00289991|Secondary|Time to Breakthrough Invasive Fungal Infection (IFI)|Summary of time (in days) from start of prophylaxis to first recorded occurrence of breakthrough proven or probable IFI.|Day 1 up to Day 180 (Visit 9)|MITT; data from 1 site excluded due to GCP deviations. Analysis excludes additional data on IFIs that were only captured on European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) worksheets (not on Case Report Forms or in the database). Times were summarized only for subjects who experienced a breakthrough IFI.||days||95% Confidence Interval|Mean
160048|NCT00289991|Secondary|Success at Day 100: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 100 days after allogeneic HSCT. Success defined as: alive at Day 100 (Visit 7), had not developed a breakthrough proven or probable IFI by Visit 7, and received full course of study drug prophylaxis without an interruption of >14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 7, imputed as failure at Visit 7 (programmatically).|Day 100 (Visit 7)|MITT; data from 1 site excluded due to GCP deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.||percent of participants|||Number
160049|NCT00289991|Primary|Success at Day 180: Percent of Responders (Randomization Strata)|Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).|Day 180 (Visit 9)|Modified Intent to Treat (MITT): primary analysis population; all randomized subjects: received at least 1 dose of randomized study drug and had allogeneic HSCT; data from 1 site excluded due to Good Clinical Practice (GCP) deviations; (n)=number of subjects with analyzable data at observation for voriconazole and itraconazole, respectively.||percent of participants|||Number
160094|NCT00289536|Secondary|Mean Residence Time|Computed as total AUMC divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||hour||Full Range|Median
163918|NCT00243061|Secondary|Stable Disease Duration||From the start of the treatment until the criteria for progression are met, assessed up to 6 years||||||
160050|NCT00289978|Secondary|Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline|The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.||T2 lesions|Participants|Standard Deviation|Mean
160051|NCT00289978|Secondary|Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.|Baseline to end of study (Month 24)|Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.||Percentage of participants||95% Confidence Interval|Number
160052|NCT00289978|Primary|Estimated Annualized Aggregate Relapse Rate (ARR)|The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.|Baseline to end of study (Month 24)|This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug.||Relapses per year||95% Confidence Interval|Number
160053|NCT00289913|Primary|Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™|"GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.~IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.~IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.~IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL."|4 weeks postvaccination with Infanrix™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.||ELISA units per mL (ELU/mL)||95% Confidence Interval|Geometric Mean
160054|NCT00289913|Primary|Number of Participants With Adverse Events (AE)|"Systemic and injection site AEs were collected from participants receiving~VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)~VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)~VAQTA™ administered alone (Stage II)~Safety data was collected on a standardized Vaccination Report Card (VRC)~following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE."|Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs|Participants administered at least one dose of vaccine, for whom follow-up was available.||Participants|||Number
160055|NCT00289913|Primary|Antibody Response Rate to Haemophilus Influenzae Type b (Hib)|"Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.~The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™."|4 weeks postvaccination with PedvaxHIB™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.||Percentage of participants||95% Confidence Interval|Number
160056|NCT00289913|Primary|Seropositivity Rate (SPR) to Hepatitis A|SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).|4 weeks after dose 2 of VAQTA™|The per-protocol population, which consisted of all Stage I participants who received vaccinations within the specified day ranges, completed appropriate follow-up, and were without any pre-specified protocol violations.||Percentage of participants||95% Confidence Interval|Number
160057|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
164317|NCT00234286|Secondary|Number of Patients Who Died in ICU|Location of death (ICU vs. other) based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
160058|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160059|NCT00289900|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160060|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Laboratory Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|up to 14 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160061|NCT00289900|Secondary|Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160062|NCT00289900|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up to 14 weeks|All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160063|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Diabetes|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and did not have diabetes at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160064|NCT00289900|Secondary|Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose|Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became ‘impaired’ during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and normal glycemic status at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160065|NCT00289900|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160068|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160069|NCT00289900|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160070|NCT00289900|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up to 12 weeks|All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled.||Percentage of Participants|||Number
160071|NCT00289900|Secondary|Percentage Change From Baseline in TC/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
160072|NCT00289900|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP)|Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Median
160073|NCT00289900|Secondary|Percentage Change From Baseline in Lipoprotein (a) (Lp[a])|Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Median
160074|NCT00289900|Secondary|Percentage Change From Baseline in Total Cholesterol (TC)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
160075|NCT00289900|Secondary|Percentage Change From Baseline in Apo A-I|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
160076|NCT00289900|Secondary|Percentage Change From Baseline in Apolipoprotein (Apo) B|Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
160077|NCT00289900|Secondary|Percentage Change From Baseline in LDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
160078|NCT00289900|Secondary|Percentage Change From Baseline in Non-HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
160079|NCT00289900|Secondary|Percentage Change From Baseline in Triglycerides (TG)|Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Median
160080|NCT00289900|Secondary|Percentage Change From Baseline in HDL-C|Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage change||95% Confidence Interval|Least Squares Mean
163596|NCT00247676|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
160081|NCT00289900|Primary|Percentage Change From Baseline in the LDL-C/HDL-C Ratio|Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.|Baseline and Week 12|All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint.||Percentage Change||95% Confidence Interval|Least Squares Mean
160082|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
160083|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
160084|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
160085|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
160086|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
160087|NCT00289887|Primary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline."|At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)|"An all patients treated approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment."||mm Hg||Standard Error|Least Squares Mean
160088|NCT00289874|Secondary|"Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period"|Percent change from baseline in average daily β-agonist use over the 3-week treatment period|Baseline and Week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).||Percent Change||Standard Deviation|Median
160089|NCT00289874|Primary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|Percent change from baseline in FEV1, a measure of airway function, at Week 3|Baseline and week 3|The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).||Percent Change||95% Confidence Interval|Least Squares Mean
160090|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Antigen (VWF:Ag)|Percentage of VWF:Ag. Relationships between baseline VWF:Ag and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s).||U/dL||Full Range|Median
160091|NCT00289536|Secondary|Pre-infusion Von Willebrand Factor Ristocetin Cofactor Activity (VWF:Rco)|Percentage of normal VWF:Rco activity. Normal is a lab standard consisting of a non-hemophilic population. Relationships between baseline VWF:Rco and pharmacokinetic parameters (initial recovery, total AUC/dose, and half-life) were evaluated statistically.|At baseline and before each pharmacokinetic evaluation|Intent to treat: participants who received at least 1 of the 3 infusions of rAHF-PFM and had pharmacokinetic evaluation(s)||Percent of normal VWF:Rco activity||Full Range|Median
160092|NCT00289536|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration after infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU/dL||Full Range|Median
160093|NCT00289536|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted CL * Mean Residence Time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||dL/kg||Full Range|Median
160098|NCT00289536|Secondary|Area Under the Curve|AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour/dL||Full Range|Median
160099|NCT00289536|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model (the slope is biphasic). Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||hour||Full Range|Median
160100|NCT00289536|Secondary|Area Under the Curve/Dose|Area under the plasma factor VIII concentration versus time curve (AUC) estimated by linear trapezoidal method per dose.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU*hour/dL per IU/kg||Full Range|Median
160101|NCT00289536|Primary|Initial Recovery|Percent increase in factor VIII concentration per dose from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Per protocol population: participants who were randomized, received all 3 doses of rAHF-PFM, and had pharmacokinetic assessments.||IU/dL per IU/kg||Full Range|Median
160102|NCT00289471|Primary|Performance Characteristics|Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment|Cross-sectional [at baseline; no longitudinal component]|||Percentage of participants||95% Confidence Interval|Number
160103|NCT00289458|Primary|Change in Dual Task Function|change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)|baseline and 11 weeks|||unit of scale (seconds)||Standard Deviation|Mean
160104|NCT00289458|Secondary|Change in Physical Activity|change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)|baseline and 11 weeks|||unit of scale||Standard Deviation|Mean
160105|NCT00289458|Primary|Change in Falls-Efficacy|change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)|baseline and 11 weeks|ITT and LOCF||unit of scale||Standard Deviation|Mean
160106|NCT00289458|Primary|Change in Walking|change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks|baseline and 11 weeks|ITT and LOCF||unit of scale (meters per 6 minutes)||Standard Deviation|Mean
160107|NCT00289458|Primary|Change in Chair Stands|change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)|baseline and 11 weeks|ITT and LOCF||number of stands per 30 seconds||Standard Deviation|Mean
160108|NCT00289458|Primary|Change in Balance|Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)|baseline and 11 weeks|ITT and LOCF||units on a scale||Standard Deviation|Mean
160109|NCT00289341|Secondary|Change in PSA Slope, Pre- vs Post-vaccination.|To model the evolution of PSA (in log-scale) during the three study phases (pre-vaccine, vaccine, and post-vaccine phases), a mixed linear spline model was used. Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase. To account for the heterogeneous treatment effect and the repeated measures structure, random effects are incorporated into the model. For the general model, random effects for the intercept, slope and the first knot were considered.|pre- vs post- vaccination PSA slopes.|23 of 24 patients were analyzed. 1 patient was not evaluable.||log₂(ng/ml)/month||95% Confidence Interval|Number
160110|NCT00289341|Primary|"Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The Number Indicated is the Median Difference of Post-Pre, of Each Antigen Group."|The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.|pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13|The Arm/Group Title is different for this outcome. In the 1st outcome analysis, AEs were being compared between placebo and tx groups. After the blinded phase, placebo pts crossover and we compare pre-vs post vaccination T cell proliferation in all pts. 22 of 24 pts'assays were analyzed. Two were excluded as they failed internal controls.||cells *10^3 per minute||95% Confidence Interval|Median
160111|NCT00289341|Primary|Adverse Event|Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.|End of blinded phase (wk 9)|All AEs occurring 5 or more times during the study were analyzed. All AEs reported are grade 1 except as noted.||Adverse Events|||Number
160112|NCT00289289|Secondary|Atrial Tachycardia/Atrial Fibrillation (AT/AF) Burden|AT/AF burden is defined as the sum of the duration of all atrial arrhythmias as recorded by the device divided by the device follow-up time during the programming period expressed as hours of atrial arrhythmia per day.|6 months (per Intervention)|Of the 256 randomized to ON-OFF or OFF-ON programming, 225 had device data necessary for computing AT/AF burden in both randomized study periods.||hours per day||Standard Deviation|Mean
160113|NCT00289289|Secondary|Time to First Cardioversion (Changing an Abnormal Heart Rhythm Into a Normal One by Using Either Medication or Electrical Shock)|The dates of cardioversions attempted for atrial fibrillation (AF) since the previous study visit were collected at the 3, 9, and 15 month follow-up visits. For each randomized subject, the months to first attempted cardioversion during each randomized study period (3-9 months and 9-15 months) was determined. A repeated measures Cox proportional hazards model was used to compare the attempted cardioversion rate during periods of time where the pacing features were programmed ON versus OFF.|6 months (per Intervention)|All randomized subjects with follow-up during intervention pacing feature programming period.||Months||Standard Deviation|Mean
160127|NCT00289185|Secondary|Number of Subjects Prevalent for Parasitemia|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.||Subjects|||Number
160114|NCT00289289|Secondary|Evaluate Subject Symptoms With the Atrial Fibrillation (AF) Symptom Checklist|The AF symptom checklist (SCL) is a 16 item questionnaire measuring the frequency of 16 arrhythmia related symptoms such as tiredness/lack of energy, heart fluttering/skipping, heart racing, lightheadedness, etc. Symptom frequency is rated as never (scored as 0), rarely (scored as 1), sometimes (scored as 2), often (scored as 3), and always (scored as 4). Scores are summed across each subject and timepoint and range from 0 (no symptoms) to 64 (always symptoms). For each subject the 9 month and 15 months scores were summed respectively and ON minus OFF differences computed.|6 months (per Intervention)|Of the 256 randomized subjects only 211 completed the AF symptom checklist at both the 9-month and 15-month visit. Since this was a crossover study, data from both visits was required for the subject to be included in the analysis||Scores on a scale||Full Range|Median
160115|NCT00289289|Primary|Rate of Symptomatic Atrial Tachycardia/Atrial Fibrillation Episodes Per Subject Per Month|The frequency of symptomatic atrial tachycardia/atrial fibrillation (AT/AF) episodes as measured by the Patient Assistant and retrieved from save-to-disk information. For each subject and programming period (3-9 month period and 9-15 month period), the rate of symptomatic AT/AF episodes was computed by summing the total number of Patient Assistant activations during device recorded AT/AF episodes divided by months of device follow-up in each study period. Within each subject, the ON minus OFF difference in rate of symptomatic AT/AF was computed|6-months (per Intervention)|Patient Assistant data which contained markers for symptomatic atrial tachycardia or atrial fibrillation episodes obtained from save-to-disk data was required from both randomized follow-up periods (3-9 months and 9-15 months) for the subject to be included in the primary ITT analysis.||Episodes per subject per month||Standard Deviation|Mean
160116|NCT00289276|Secondary|Number of Adverse Events|All adverse events were collected for this trial such as (but not limited to): Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|From enrollment to study exit (up to 36 months).|Number of participants analyzed for this outcome is limited to subjects who experienced at least one Adverse Event from enrollment to study exit.||Adverse Events|||Number
160117|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Outpatient Treatment of an Exacerbation of HF|Difference in mean thoracic impedance: post-outpatient visit minus pre-outpatient visit.|1 day pre and 1 day post-outpatient visit|All subjects with at least one heart failure outpatient treatment and with impedance data pre and post-outpatient treatment.||Ohms||Full Range|Mean
160118|NCT00289276|Secondary|Change in Thoracic Impedance Associated With Heart Failure (HF) Hospitalization for an Exacerbation of HF|Difference in mean thoracic impedance: post-hospitalization minus pre-hospitalization.|3 days pre-admission and 3 days post-discharge|All subjects with at least one heart failure hospitalization and with impedance data pre and post-hospitalization.||Ohms||Full Range|Mean
160119|NCT00289276|Primary|Number of Subjects With at Least 30 Days of Daily Impedance Measurements|Impedance measurements were presented graphically over time in relation to clinical events for all subjects with at least 30 days of follow-up and impedance data collected during the follow-up period.|Up to 36 months.|Includes all enrolled participants.||participants|||Number
160120|NCT00289211|Secondary|Complement C4 Serum Levels|Change in complement C4 serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.||mg/dL||Standard Deviation|Mean
160121|NCT00289211|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH)."|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.||percent of functional C1INH||Standard Deviation|Mean
160122|NCT00289211|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug.|Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion|ITT-E subjects (N=68) with data available.||mg/dL||Standard Deviation|Mean
160123|NCT00289211|Secondary|Time to Complete Resolution of the HAE Attack|Randomized subjects were contacted 72-96 hours (3-4 days) after discharge from the study site to determine when complete resolution of the HAE attack occurred.|72 hours|ITT Population.||hours||95% Confidence Interval|Median
160124|NCT00289211|Secondary|Number of Subjects With Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|ITT-Efficacy (ITT-E) Population (N=68; 3 of the 71 randomized [ie, ITT] subjects were excluded from the ITT-E Population, as it was later determined that they did not experience a definitive hereditary angioedema [HAE] attack).||participants|||Number
160125|NCT00289211|Primary|Time to Beginning of Substantial Relief of the Defining Symptom|Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.|Within 4 hours after initial treatment|Intent-to-treat (ITT) Population (all randomized subjects). Since less than 50% of subjects in the placebo group achieved the endpoint, median time to event was not estimable (NE). Further, the number of censored events in the C1INH-nf and placebo groups precluded estimation of the 95% confidence interval (CI) upper bound for median time to event.||hours||95% Confidence Interval|Median
160126|NCT00289185|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (Subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 7 months after administration of Dose 3 of RTS,S or HBV vaccine (Month 9). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. This outcome for solely assessed in the Engerix-B Group, as no subject in the RTS,S/AS02D was assessed as prevalent for parasitemia.|At Month 9|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.||Parasite per microliter (µL)||Full Range|Mean
160128|NCT00289185|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome variables were available.||n/PYAR|||Number
160129|NCT00289185|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study, from Week 0 to Month 20.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
160130|NCT00289185|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days (Days 0–29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subjects|||Number
160131|NCT00289185|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability, and loss of appetite. Fever was defined as axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C).|Within 7 days (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
160132|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the TETRActHib vaccine..|Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
160133|NCT00289185|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling following vaccination with the RTS,S/AS02D or Engerix-B vaccine.|Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
160134|NCT00289185|Secondary|Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of 0.5 EL.U/mL.|Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||ELISA unit per milliliter||95% Confidence Interval|Geometric Mean
160135|NCT00289185|Primary|Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
160136|NCT00289185|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subjects|||Number
160137|NCT00289185|Primary|Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subject|||Number
160138|NCT00289185|Primary|Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subject|||Number
160139|NCT00289185|Primary|Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value|The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||Subject|||Number
160140|NCT00289185|Primary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||ELISA unit per millilite||95% Confidence Interval|Geometric Mean
160141|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 9 to Month 20.|||Subject|||Number
160142|NCT00289185|Primary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||international unit per milliliter||95% Confidence Interval|Geometric Mean
160143|NCT00289185|Primary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||international unit per milliliter||95% Confidence Interval|Geometric Mean
160144|NCT00289185|Primary|Concentrations of Antibodies Against Diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||international unit per milliliter||95% Confidence Interval|Geometric Mean
160145|NCT00289185|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Week 0 to Month 9.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||Subject|||Number
160146|NCT00289185|Primary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.|Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||milli-international unit per milliliter||95% Confidence Interval|Geometric Mean
160147|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|||Number
160148|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Osteolysis (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which radiographs were analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|||Number
160149|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Tibial Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees in which the radiographs were analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|||Number
160150|NCT00289133|Secondary|Radiographic Outcomes - Percentage of Knees With Femoral Radiolucencies (>2mm)||Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||percentage of knees|||Number
160167|NCT00289094|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
160168|NCT00289094|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
160169|NCT00289094|Secondary|Complications/Revisions||On-going to end of study.||||||
164318|NCT00234286|Secondary|Do Not Resuscitate Order|Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
160151|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The max total score is 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores (points) on a scale||Standard Deviation|Mean
160152|NCT00289133|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC) Osteoarthritis Total Score|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subjects with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint. The max total score is 96. The subscales are combined (summed) to compute a total score, where a lower score indicates a better outcome.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores (points) on a scale||Standard Deviation|Mean
160153|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Minimum 5 years, up to 7.6 years|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores on a scale||Standard Deviation|Mean
160154|NCT00289133|Secondary|American Knee Society Evaluation - Total Score|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 year|The number of knees analyzed was the number available for analysis at this post-operative timepoint.||scores on a scale||Standard Deviation|Mean
160155|NCT00289133|Primary|Survivorship (Revision of Any Component for Any Reason)|Survival was estimated by Kaplan-Meier method. Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 years|Survivorship can only be calculated on knees (not participants as some study subjects had bilateral knees in the study) with post-operative follow-up. 35 knees were excluded due to post-operative follow-up not being available. 67 knees were excluded due to protocol violations.||percentage of knees|Participants|95% Confidence Interval|Number
160156|NCT00289120|Primary|The Plasma and Urine Parameters|"The Urine Parameters that were assessed at the end of cola and water (arms) phase:~Urine Parameters:~uNa (mEq per d) uK (mEq per d)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase|||mEq per d||Standard Deviation|Mean
160157|NCT00289120|Secondary|Urinary pH|"The Urine pH that were assessed at the end of cola and water (arms) phase The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase|||pH||Standard Deviation|Mean
160158|NCT00289120|Secondary|Total Urine Volume|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Urine Parameters:~Total Urine Volume (mL/day)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase|||mL/day||Standard Deviation|Mean
160159|NCT00289120|Primary|The Plasma Osmolarity|"The Plasma osmolarity that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~OSM (mOsm/L)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of cola and water phase|||mOsm/L||Standard Deviation|Mean
160160|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per L)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of 6-day intervention of Cola and water phase|||mEq/L||Standard Deviation|Mean
160161|NCT00289120|Primary|The Plasma and Urine Parameters|"The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase:~Plasma Parameters:~CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL)~Urine Parameters:~uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL)~The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).~measure of dispersion was standard deviation."|at the end of each 6-day intervention in Cola and Water Phase|||mg per dL||Standard Deviation|Mean
160162|NCT00289107|Secondary|SF-12 Patient Outcomes||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
160163|NCT00289107|Secondary|Medical Imaging||Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.||||||
160164|NCT00289107|Secondary|Revisions||On-going to end of study||||||
160165|NCT00289107|Secondary|Complications||On-going to end of study||||||
160166|NCT00289107|Primary|Knee Society Score|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||Scores on a scale||Standard Deviation|Mean
160170|NCT00289094|Primary|Knee Society Scores|The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.|Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.|||Scores on a scale||Standard Deviation|Mean
160171|NCT00289016|Secondary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).~Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days.|ITT population||participants|||Number
160172|NCT00289016|Secondary|Duration of Response|Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)||days||Full Range|Median
160173|NCT00289016|Secondary|Time to Longest Continuous Response|Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant’s last response interval.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population with an objective response (PR or CR)||days||Full Range|Median
160174|NCT00289016|Secondary|Time to Progression|"Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease.~Median time to progression was calculated using the Kaplan-Meier method."|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.|ITT population||days||Full Range|Median
160175|NCT00289016|Secondary|Overall Survival|Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method.|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|ITT population||days||Full Range|Median
160176|NCT00289016|Primary|Objective Tumor Response Rate|"Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart.~Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:~Complete response (CR): zero tumor burden~Partial response (PR): a 30% or greater decrease in tumor burden~Progressive disease (PD): a 20% or greater increase in tumor burden~Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days|Intent-to-treat (ITT) population (all participants who received at least 1 dose of talimogene laherparepvec)||percentage of participants|||Number
160177|NCT00288912|Secondary|Arthritis Self Efficacy|The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
160178|NCT00288912|Secondary|AIMS 2 Affect|The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse affect.|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
160179|NCT00288912|Secondary|AIMS 2 Physical Function|The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale (“all days” to “no days”). Scores can range from 0-10, with higher scores indicating worse function.|Baseline and 12-month follow-up|||units on a scale||Standard Deviation|Mean
160180|NCT00288912|Primary|Pain|Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale (“all days” to “no days”). The possible range of scores is 0-10, with higher scores indicating more severe pain.|Baseline and 12-month follow-up|||units on a scale||Standard Deviation|Mean
160181|NCT00288886|Secondary|Rates of Hospitalization (Across the Prior 90 Days)|Number of days hospitalized for any reason per the previous 90 days|Assessed at Baseline, 3-, 6-, and 12-months|||days||Standard Deviation|Mean
160182|NCT00288886|Secondary|Days of Substance Abuse (Across the Prior 90 Days)||Assessed at Baseline, 3-, 6-, and 12-month follow-up|||percentage of 90 days||Standard Deviation|Mean
160183|NCT00288886|Secondary|Self-help Support Group Attendance||Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year|||days||Standard Deviation|Mean
160184|NCT00288886|Secondary|Aftercare Attendance|Measures of aftercare attendance include: Percentage of participants who attended at least 1 aftercare session; percentage of participants who attended at least 2 aftercare sessions/month for at least 3, 6, 9 and 12 months; and percentage of participants who passed the VAMC's SUD continuity of care performance measure (a benchmark for retention of clients in aftercare for at least two visits each month for 3 months following initial treatment)|Assessed at 3-, 6-, 9-, and 12-months|||percentage of participants|||Number
160185|NCT00288886|Secondary|Days Until First Use of Alcohol or Drugs||Baseline to 12 months|||days||Standard Deviation|Mean
160186|NCT00288886|Secondary|Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 3 and 6 months|||participants|||Number
160187|NCT00288886|Primary|Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90|Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.|Assessed at 12 months|||participants|||Number
160188|NCT00288860|Primary|Rehospitalization|Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program|12 months post discharge|||participants|||Number
160189|NCT00288860|Secondary|Depressive Symptoms, Subjective Quality of Life|Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)|12 months post-discharge (8 months post intervention)|||units on a scale||Standard Deviation|Mean
160190|NCT00288860|Primary|Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms|"Higher scores are worse outcomes on all four measures:~Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)"|12 months post-discharge (8 months post intervention)|||Scores on a scale||Standard Deviation|Mean
160191|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Number of Disease Flare Days|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.~A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue)."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.||Number of Days||Standard Deviation|Mean
160192|NCT00288704|Other Pre-specified|Change From Baseline to Open-Label Extension Week 72 in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that FCAS/MWS affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement.~OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis."|From Baseline (Week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.||Units of a Scale||Standard Deviation|Mean
160193|NCT00288704|Other Pre-specified|Summary of Mean Change From Baseline to Open-Label Extension Week 72 in KSS|"OLE Week 72 was the last timepoint at which efficacy was measured in the study. 56 of the 101 OLE subjects were included in the analysis.~The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).~A negative change in mean values indicated improvement in symptoms."|From Baseline (week 0) to OLE Week 72|44 subjects entered from part A of the study, and 12 subjects entered directly into the OLE. No placebo subjects were in the OLE.||Units of a scale||Standard Deviation|Mean
160194|NCT00288704|Other Pre-specified|Number of Subjects With at Least 75% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)|||Participants|||Number
160195|NCT00288704|Other Pre-specified|Number of Subjects With at Least 50% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Week 6 (Part A)|||Participants|||Number
160196|NCT00288704|Other Pre-specified|Number of Subjects With at Least 30% Improvement in Key Symptoms Scores (KSS) From Baseline to Endpoint (Week 6)|The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).|Baseline to Endpoint (Week 6)|||Participants|||Number
160197|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in Serum Amyloid A (mg/L)|An abnormal value for SAA was considered > 6.4 mg/L.|Baseline to Endpoint of Part A|||Milligrams per Liter||Standard Deviation|Median
160198|NCT00288704|Other Pre-specified|Median Change From Baseline to Week 6 (Part A) Endpoint in C-Reactive Protein (mg/L)|An abnormal value for CRP was considered > 8.4 mg/L.|Baseline to Endpoint of Part A|||Milligrams per Liter||Standard Deviation|Median
160199|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Patient's Global Assessment|"The Patient's Global Assessment was a question on the Daily Health Assessment Form Considering all the ways that Familial Cold Autoinflmatory Syndrome (FCAS) /Muckle-Wells Syndrome (MWS) affects you, please rate how you are doing based on the following scale 0=very well to 10=very poor. A negative value in change in Patient's Global Assessment is indicative of an improvement."|Baseline to Week 6 (Part A)|||Visual Analog Scale||Standard Deviation|Mean
160200|NCT00288704|Other Pre-specified|Change From Baseline to Endpoint (Week 6) in Physician's Global Assessment|The Physician's Global Assessment was an evaluation at each visit on a scale of 0=no disease activity to 10=severe disease activity. A negative value in change in Physician's Global Assessment is indicative of an improvement.|Baseline to Week 6 (Part A)|||Units of a Scale||Standard Deviation|Mean
160201|NCT00288704|Other Pre-specified|Mean Change From Baseline to Endpoint (Week 6) in Number of Disease Flare Days Per Patient|"A Disease flare day was any day where the mean Key Symptom Score (KSS) was greater than 3. The KSS was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was calculated for 21 Day Periods at baseline and at the endpoint (from Weeks 3 - 6). The difference in the number of flares between the two periods was averaged for all subjects.~The DHAF was used because it is a validated instrument to collect subject's self-reported responses. It was the basis for the KSS and the flare day count."|Baseline to Week 6 (Part A)|||Days||Standard Deviation|Mean
160202|NCT00288704|Primary|Mean Change in Key Symptom Score (KSS) From Week 15 to Week 24 (During the Randomized Withdrawal Phase or Part B)|"The mean Key Symptom Score (KSS --from the validated, patient-administered DHAF) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue).~Subjects all received rilonacept 160 mg from week 6 through week 14. At week 15, subjects were re-randomized in a 1:1 ratio between Placebo and rilonacept 160 mg. Subjects baseline period was the 21-day period prior to week 15 randomization.~A positive score indicated a worsening of symptoms versus an active treatment rilonacept baseline period."|Week 15 through Week 24 (randomized withdrawal)|Subjects were re-randomized as part of the randomized withdrawal period (Part B). Subjects were not necessarily assigned the same treatment as in the first double-blind portion (Part A). Subjects were analyzed using last observation carried forward.||Units of a Scale||Standard Deviation|Mean
160203|NCT00288704|Primary|Change From Baseline to Week-6 (Part A) Endpoint in Mean Key Symptom Score (KSS)|"The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was averaged over two 21-day daily reporting periods (the 3 weeks prior to both baseline and week 6). In part A, a negative change in mean values indicated improvement under treatment with rilonacept in symptoms.~The DHAF was used because it is a validated instrument to collect subject's self-reported responses."|Baseline (Days -21 to -1) and Week 6 (Days 21-42)|Cryopyrin Associated Autoinflammatory Syndrome (CAPS) is a rare, orphan, hereditary disease. There are several hundred CAPS cases in the United States.||Units of a Scale||Standard Deviation|Mean
160204|NCT00288639|Secondary|Subjects Assessment of Optimal Sleep|Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale.|Baseline, End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).||participants|||Number
160205|NCT00288639|Secondary|Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline|Count of subjects with a weight gain of at least 7 percent relative to baseline.|Baseline, End of 21-week treatment|"Safety population (all subjects who had taken at least~1 dose of study drug)."||participants|||Number
160206|NCT00288639|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.|Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21.|Baseline, End of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."||score on scale||95% Confidence Interval|Mean
160207|NCT00288639|Secondary|Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores|Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 – 1.|Baseline, end of 21-week treatment|"Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). n is the number of subjects contributing to the mean at the specified time point."||score on scale||95% Confidence Interval|Mean
160208|NCT00288639|Secondary|Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)|The CGIC is a clinician’s judgment of the overall change in the patient’s condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).||partcipants|||Number
160209|NCT00288639|Secondary|Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)|The PGIC is a patient-rated instrument that measures change in patient’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|End of 21-week treatment|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period).||participants|||Number
160223|NCT00288587|Primary|Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.||4 consecutive hours (+/- 30 minutes)|Analysis was performed on the intent-to-treat group which consisted of all patients enrolled in this study.||hours||Standard Deviation|Mean
160210|NCT00288639|Secondary|Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency|Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline observation period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) (all subjects who received at least 1 dose of study treatment & minimum 2 partial seizures during baseline pd). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||percentage change in events||Full Range|Median
160211|NCT00288639|Secondary|Subjects Achieving Seizure Freedom During Observation Period|Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period.|Day 147 from the first dose of study drug|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period).||participants|||Number
160212|NCT00288639|Secondary|Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.|Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period.|8 week baseline observation period & last 4 weeks of observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Patients who discontinued less than 4 weeks into the observation period (after Visit 3/week 9) will be regarded as missing. No data prior to week 9 will be used.||participants|||Number
160213|NCT00288639|Secondary|Number of Subjects Seizure-free|Count of subjects seizure free during the period.|last 4 weeks & whole 12 week treatment observation period|Full analysis set(FAS)/intent-to-treat(ITT) all subjects who received >= 1 dose of study Tx & >= 2 partial seizures during baseline pd. LOCF if subjects withdrew then last 4 wks prior to last dose (but after visit 3). 12 wk subjects who withdrew were regarded as missing. n= # subjects evaluable for seizure freedom during defined observation pd.||participants|||Number
160214|NCT00288639|Post-Hoc|Change in Partial Seizure Frequency by Type Between the 8 Week Baseline Period and During the 12 Week Observation Period.|Change from baseline = 12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate.|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||change in median partial seizures||Full Range|Median
160215|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.|Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure date from patients who discontinued during any of these 4 week intervals will not be included in the summary for that interval.||percentage change of events||Full Range|Median
160216|NCT00288639|Secondary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.|Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency.|8 week baseline period and 21 week treatment period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||percentage change in events||Full Range|Median
160217|NCT00288639|Primary|Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period|Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).|8 week baseline period & 12 week treatment observation period|Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.||percentage change in events||Full Range|Median
160218|NCT00288600|Primary|Need of Exchange Transfusion|NEED OF EXCHANGE TRANSFUSION FOLLOWING GUIDELINES|10 DAYS OF LIFE|NUMBER||participants|||Number
160219|NCT00288587|Secondary|Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths|Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.|Hospital discharge to 90 days after discharge|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.||participants|||Number
160220|NCT00288587|Secondary|Volume Removal Rate.|Hours of therapy required to remove 1 liter of fluid normalized to body weight.|Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.||milliliters/hour/kilogram||Standard Deviation|Mean
160221|NCT00288587|Secondary|Total Volume Removal During the Intervention Period||Intervention start to end.|The analysis population is the intent-to-treat group which includes all patients enrolled on the study.||milliliters||Standard Deviation|Mean
160222|NCT00288587|Secondary|Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.||Time from admission to endpoint achievement|The analysis population was the intent-to-treat group, represented by all patients enrolled in this study.||Days||Standard Deviation|Mean
160224|NCT00288574|Primary|Proportion of Patients Remaining in Study at 1 Year|The primary outcome measure was the proportion of patients with AN successfully completing 1 year of treatment and maintaining > 85% Ideal Body Weight.|12 months|||percentage of patients|||Number
160225|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for pain is from 0 (no pain) to 20 (max pain). For each treatment cycle, the change in TWSTRS pain subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS pain subscale scores have been included in the pain subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS pain subscale score analyses."||points on a scale||Standard Deviation|Mean
160226|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for disability is from 0 (no disability) to 30 (max disability). For each treatment cycle, the change in TWSTRS disability subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS disability subscale scores have been included in the disability subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS disability subscale score analyses."||points on a scale||Standard Deviation|Mean
160227|NCT00288509|Secondary|Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for severity is from 0 (absence of severity) to 35 (max severity). For each treatment cycle, the change in TWSTRS severity subscale is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~All available TWSTRS severity subscale scores have been included in the severity subscale analyses. Subjects excluded from the TWSTRS total score analyses may have their available data included in the TWSTRS severity subscale score analyses."||points on a scale||Standard Deviation|Mean
160228|NCT00288509|Primary|Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. For each treatment cycle, the change in TWSTRS total score is the score at week 4 minus the score at baseline.|Week 4 follow-up visit|"The intention to treat population consisted of all 108 subjects who received Dysport.~Subjects with incomplete TWSTRS scores were not included in the TWSTRS total score analyses."||points on a scale||Standard Deviation|Mean
160229|NCT00288080|Other Pre-specified|To Collect Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses||From randomization to four years, any further data collected at time of analysis will be included.||||||
160230|NCT00288080|Secondary|Validity of PSA-defined Endpoints as a Surrogate for Overall Survival||From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.||02/2018||||
160231|NCT00288080|Secondary|The Time Interval Between Biochemical Failure and Distant Metastases With Respect to Testosterone Level||From date of biochemical failure to development of distant failure. Analysis occurs after all patients have been potentially followed for 4 years.||02/2018||||
160232|NCT00288080|Secondary|Incidence of Adverse Events|Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.|From start of treatment until the end of follow-up|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants|||Number
160233|NCT00288080|Secondary|Disease-free Survival|A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
160234|NCT00288080|Secondary|Distant Metastasis|Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.|From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
160235|NCT00288080|Secondary|Local Control|Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.|From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
160263|NCT00287716|Secondary|Change in Six-Minute Walk Test (6MWT)Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).|Baseline to Week 72|||Change in Distance Walked in Meters||Standard Deviation|Mean
161644|NCT00271544|Secondary|All Medtronic Left Ventricular Leads (Attain Family)|All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted|Implant|Subjects who underwent an implant attempt.||participants|||Number
160236|NCT00288080|Secondary|Biochemical Control|Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.|From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
160237|NCT00288080|Primary|Overall Survival|Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.|Eligible patients who did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
160238|NCT00288067|Primary|Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)|The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.|Up to 7 years|No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).||participants|||Number
160239|NCT00288067|Primary|Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)|"A group of 3 patients would start treatment ast the dose of 900mg/m^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy.~Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI:~Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses >1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD."|Number of participants that experienced a dose-limiting toxicity|7 participants were analyzed in the Rituximab Naive arm and 16 participants were analyzed in the Rituximab Pre Treated Arm.||participants|||Number
160240|NCT00288054|Secondary|Response Rate|Confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease (as defined per RECIST). A confirmed complete response (CR) is defined as disappearance of all disease, confirmed by a second determination of CR at least 4 weeks later. A confirmed partial response (PR) is defined as a >= 30% decrease from baseline in the sum of longest diameters, confirmed by a second determination of PR at least 4 weeks later. A patient is considered to have measurable disease if they have at least one lesion with a longest diameter of >= 2 cm by conventional CT, or >= 1 cm by spiral CT.|Week 10 and week 22|Eligible patients who began protocol treatment and who had measurable disease (as defined by RECIST) at baseline were included in the analysis.||percentage of participants||95% Confidence Interval|Number
160241|NCT00288054|Secondary|Progression-free Survival.|Duration from the date of enrollment until the date of progression (as defined by RECIST: >= 20% increase over baseline in the sum of longest diameters, or appearance of new lesions, or non-measurable disease that is clearly worsening in the opinion of the treating investigator, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and free of disease progression are censored at the date of last contact.|At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.|Eligible patients who began protocol treatment were included in the analysis.||months||95% Confidence Interval|Number
160242|NCT00288054|Secondary|Overall Survival|The duration form the date of enrollment until the date of death due to any cause. Patients last known to be alive are censored at the date of last contact.|weekly while patient is on protocol treatment, then monthly thereafter.|Eligible patients who began protocol treatment were included in the analysis.||months||95% Confidence Interval|Median
160243|NCT00288054|Primary|Treatment-related Esophagitis or Pneumonitis|The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.|Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.|Eligible patients who received protocol treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
160244|NCT00288054|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.|Eligible patients who received protocol treatment.||Participants|||Number
160245|NCT00287872|Secondary|Quality of Life||0-6 months||||||
160246|NCT00287872|Secondary|The Time to Response||1-6 months||||||
160247|NCT00287872|Secondary|Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation||1-6 months||||||
160248|NCT00287872|Secondary|Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)|Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).|1-6 months|||participants|||Number
160249|NCT00287872|Primary|Clinical Response to Treatment|Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria.|1-6 months|||persentage of participants||95% Confidence Interval|Number
160250|NCT00287729|Secondary|Worsening of IPF|"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.||Number of Patients Who Worsened|||Number
160284|NCT00286754|Primary|Blood Pressure Control|Blood pressure Control at 6 months|6 months|||proportion of participants|||Number
160251|NCT00287729|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5),with 0= not at all breathless, 4= severely breathless and 5= Maximally or unable to do because of breathlessness.|Baseline to Week 72|"A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.~Missing data were imputed by the SSD method if the patient was alive and imputed to a score of 120 if the patient died before the protocol-specified time point."||Change in Dyspnea Score||Standard Deviation|Mean
160252|NCT00287729|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs|The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.||Change in Percent Predicted DLco||Standard Deviation|Mean
160253|NCT00287729|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level. It is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 83% if the patient died before the protocol-specified time point.||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
160254|NCT00287729|Secondary|Change in the Six-Minute Walk Test (6MWT) Distance|The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes as measured in meters (m).|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0 meters if the patient had died before the protocol-specified time point.||Change in Distance Walked in Meters||Standard Deviation|Mean
160255|NCT00287729|Secondary|Progression-free Survival|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for efficacy and safety analyses.||Number of Patients with Progression|||Number
160256|NCT00287729|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experience Categorical Change in Percent Predicted Forced Vital Capacity.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is used as the primary population for all efficacy and safety analyses. Missing data were imputed by the SSD method if the patient was alive and imputed to 0% if the patient died before the protocol-specified time point.||Patients|||Number
160257|NCT00287729|Primary|Absolute Change in Percent Predicted Forced Vital Capacity(FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.|Baseline to week 72|A modified intent-to-treat population of all randomized patients who received any amount of study drug is the primary population for efficacy and safety analyses. Missing FVC data due to death were assigned the worst rank and missing FVC data due to reasons other than death were imputed using the SSD method.||Change in Percent Predicted FVC||Standard Deviation|Mean
160258|NCT00287716|Secondary|Worsening of Idiopathic Pulmonary Fibrosis (IPF)|"Worsening of IPF was defined by the occurrence of any of the following events:~Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization."|Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.|||Number of Patients Who Worsened|||Number
160259|NCT00287716|Secondary|Change in Dyspnea Score|The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness.|Baseline to Week 72|||Change in Dyspnea Score||Standard Deviation|Mean
160260|NCT00287716|Primary|Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.|From baseline up to 72 weeks|||Change in Percent Predicted FVC||Standard Deviation|Mean
160261|NCT00287716|Secondary|Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs||Baseline to Week 72|||Change in Percent Predicted DLco||Standard Deviation|Mean
160262|NCT00287716|Secondary|Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test|The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.|Baseline to Week 72|||Change,Worst Oxygen Saturation (Percent)||Standard Deviation|Mean
160264|NCT00287716|Secondary|Progression-free Survival (PFS)|Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.|Baseline to Week 72|||Number of Patients with Progression|||Number
160265|NCT00287716|Secondary|Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC)|Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity.|baseline up to 72 weeks|||Patients|||Number
160266|NCT00287339|Primary|Change in Cough-Specific Quality of Life Questionnaire|It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, “I cannot sleep at night” and “I cough and it makes me retch.” The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is “strongly disagree,” and 4 is “strongly agree.” The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment.|baseline and 12 weeks|||participants||Standard Deviation|Mean
160267|NCT00287222|Primary|Number of Participants Who Remained Free of Progression at the 27th Week.||27 weeks|Per protocol||participants|||Number
160268|NCT00287079|Primary|Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates|CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Two participants had negative time from stabilization and CDMS relapse and were excluded from the Kaplan-Meier analysis.||Month||Standard Error|Mean
160269|NCT00287079|Secondary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Up to Week 96|"Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Adverse events were not captured for No Treatment group."||percentage of participants|||Number
160270|NCT00287079|Secondary|Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)|CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.|Up to Week 96|Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population.||Percentage of participants|||Number
160271|NCT00287053|Secondary|Association of Change With a Behavioral Phenotype.||February 2006 to September 2006||||||
160272|NCT00287053|Secondary|Endocrine Response.||February 2006 to September 2006||||||
160273|NCT00287053|Secondary|Change in Body Weight.||February 2006 to September 2006||||||
160274|NCT00287053|Secondary|Change in Posture Allocation and Energy Expenditure.||February 2006 to September 2006||||||
160275|NCT00287053|Primary|Change in Food Intake.|Change in food intake from baseline to week 3.|February 2006 to September 2006|||kcal||Standard Error|Least Squares Mean
160276|NCT00286754|Secondary|Medication Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.|6 months|||participants|||Number
160277|NCT00286754|Secondary|Exercise Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.|6 months|||participants|||Number
160278|NCT00286754|Secondary|Diet Stage of Change|The stages of change were: precontemplation, or no plans to adhere in <6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for <6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.|6 months|||participants|||Number
160279|NCT00286754|Secondary|Change in Morisky Score From Baseline to 6 Months|Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent|baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
160280|NCT00286754|Secondary|Change in Number of Cardio Exercise Hours From Baseline to 6 Months||baseline and 6 months|||hours||95% Confidence Interval|Mean
160281|NCT00286754|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Baseline and 6 months|||mm Hg||95% Confidence Interval|Mean
160282|NCT00286754|Secondary|Change in Proportion With BP Under Control From Baseline to 6 Months||6 months|||Proportion of participants|||Number
160283|NCT00286754|Primary|Systolic Blood Pressure|Mean systolic Blood Pressure|6 months|||mm Hg||95% Confidence Interval|Mean
160290|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160291|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160292|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160293|NCT00286494|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||kg||Standard Error|Least Squares Mean
160294|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160295|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160296|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160297|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160298|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160299|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160300|NCT00286494|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160301|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160302|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160303|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160304|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160305|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
161645|NCT00271544|Secondary|All Left Ventricular Leads|All left ventricular leads successfully implanted|Implant|Subjects who underwent an implant attempt.||participants|||Number
160306|NCT00286494|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
160307|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160308|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160309|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160310|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160311|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160312|NCT00286494|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ratio||Standard Error|Least Squares Mean
160313|NCT00286494|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mcIU/mL||Standard Error|Least Squares Mean
160314|NCT00286494|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160315|NCT00286494|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160316|NCT00286494|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160317|NCT00286494|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160318|NCT00286494|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mcIU/mL||Standard Error|Least Squares Mean
160319|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160320|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160321|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160322|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160323|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pmol/L||Standard Error|Least Squares Mean
160324|NCT00286494|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pmol/L||Standard Error|Least Squares Mean
160325|NCT00286494|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and at least 1 post-baseline measurement.||participants|||Number
160326|NCT00286494|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and had at least 1 post-baseline FPG measurement.||participants|||Number
160327|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160328|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160329|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160330|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160331|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160332|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mg/dL||Standard Error|Least Squares Mean
160333|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160334|NCT00286494|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160349|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160335|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160336|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160337|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160338|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160339|NCT00286494|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160340|NCT00286494|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160341|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160342|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160343|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160344|NCT00286468|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160345|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160346|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160347|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160348|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160350|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160351|NCT00286468|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160352|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160353|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160354|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160355|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160356|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
160357|NCT00286468|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
160358|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160359|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160360|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160361|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160362|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||ratio||Standard Error|Least Squares Mean
160363|NCT00286468|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||ratio||Standard Error|Least Squares Mean
160364|NCT00286468|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160365|NCT00286468|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160366|NCT00286468|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160367|NCT00286468|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160368|NCT00286468|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mcIU/mL||Standard Error|Least Squares Mean
160369|NCT00286468|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mcIU/mL||Standard Error|Least Squares Mean
160370|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160371|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160372|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160373|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160374|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||pmol/L||Standard Error|Least Squares Mean
160375|NCT00286468|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||pmol/L||Standard Error|Least Squares Mean
160376|NCT00286468|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160377|NCT00286468|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set) and have at least 1 post-baseline measurement for fasting plasma glucose.||participants|||Number
160378|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160379|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160544|NCT00286078|Primary|Frequency of Adverse Event|Cumulative frequency of adverse events from randomization to 26 weeks|26 weeks|||events|||Number
160545|NCT00286078|Primary|Migraine Frequency at 12 Weeks|Change from baseline in migraine days/month at 12 weeks|Baseline and 12 weeks|Modified Intent to Treat||days||Standard Deviation|Mean
160380|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160381|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160382|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160383|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160384|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160385|NCT00286468|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160386|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160387|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160388|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160389|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160390|NCT00286468|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at week 4 due to unavailable prior value to carry forward."||mg/dL||Standard Error|Least Squares Mean
160391|NCT00286468|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160392|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 26).|The change between the value of glucagon collected at week 26 or final visit and glucagon collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
161702|NCT00270634|Primary|Biopsy Proven Acute Rejection (BPAR)|The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.|Six months|||percentage of participants|||Number
160393|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 20).|The change between the value of glucagon collected at week 20 and glucagon collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
160394|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 16).|The change between the value of glucagon collected at week 16 and glucagon collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
160395|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 12).|The change between the value of glucagon collected at week 12 and glucagon collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pg/mL||Standard Deviation|Mean
160396|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 8).|The change between the value of glucagon collected at week 8 and glucagon collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).) Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pg/mL||Standard Deviation|Mean
160397|NCT00286455|Secondary|Change From Baseline in Glucagon (Week 4).|The change between the value of glucagon collected at week 4 and glucagon collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pg/mL||Standard Deviation|Mean
160398|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160399|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160400|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160401|NCT00286455|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoint due to unavailable prior values to carry forward"||kg||Standard Error|Least Squares Mean
160402|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160403|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160404|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160405|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160406|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160407|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160408|NCT00286455|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
163597|NCT00247676|Secondary|Ctrough of SU-012662 (Metabolite of Sunitinib)|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
160409|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160410|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160411|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160412|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160413|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
160414|NCT00286455|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ng/mL||Standard Error|Least Squares Mean
160415|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160416|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160417|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160418|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160419|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ratio||Standard Error|Least Squares Mean
160420|NCT00286455|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||ratio||Standard Error|Least Squares Mean
160421|NCT00286455|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
160422|NCT00286455|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
160423|NCT00286455|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
160424|NCT00286455|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||ϻIU/mL||Standard Error|Least Squares Mean
160425|NCT00286455|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ϻIU/mL||Standard Error|Least Squares Mean
160426|NCT00286455|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||ϻIU/mL||Standard Error|Least Squares Mean
160427|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160428|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160429|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160430|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160431|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||pmol/L||Standard Error|Least Squares Mean
160432|NCT00286455|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||pmol/L||Standard Error|Least Squares Mean
160433|NCT00286455|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set).||participants|||Number
160434|NCT00286455|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL at any measurement time point during the 26 week study.|26 Weeks.|Randomized participants who received at least one dose of study drug (Full Analysis Set)and had at least 1 post-baseline FPG measurement.||participants|||Number
160435|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160436|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160437|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160438|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
161792|NCT00268762|Secondary|Arterial Complete Recanalization at 2 Hours Post tPA Bolus|Complete Recanalization as measured by either transcranial Doppler Ultrasound at 2 hours post tPA bolus.|2 hours complete recanalization post tPA bolus|||percent of patients|||Number
160439|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160440|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward"||mg/dL||Standard Error|Least Squares Mean
160441|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160442|NCT00286455|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||mg/dL||Standard Error|Least Squares Mean
160443|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160444|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160445|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160446|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160447|NCT00286455|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|"Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward."||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160448|NCT00286455|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the week 26 visit. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160449|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160450|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160451|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160452|NCT00286442|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had weight measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160453|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
160454|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
160455|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
160456|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
160457|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
160458|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
160459|NCT00286442|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set).||participants|||Number
160460|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160461|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160462|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160463|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160464|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160465|NCT00286442|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had C-peptide measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160466|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 26).|The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160467|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 20).|The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
165135|NCT00211237|Secondary|Study Treatment-related Adverse Events and Change in Neurological Status||Baseline, 1 Month , 3 Month, 6 Month and 12 Month||||||
160468|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 16).|The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160469|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 12).|The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160470|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 8).|The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF.||ratio||Standard Error|Least Squares Mean
160471|NCT00286442|Secondary|Change From Baseline in Proinsulin/Insulin Ratio (Week 4).|The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had insulin and proinsulin measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||ratio||Standard Error|Least Squares Mean
160472|NCT00286442|Secondary|Change From Baseline in Insulin (Week 26).|The change between the value of insulin collected at week 26 and insulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160473|NCT00286442|Secondary|Change From Baseline in Insulin (Week 20).|The change between the value of insulin collected at week 20 and insulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160474|NCT00286442|Secondary|Change From Baseline in Insulin (Week 16).|The change between the value of insulin collected at week 16 and insulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160475|NCT00286442|Secondary|Change From Baseline in Insulin (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160476|NCT00286442|Secondary|Change From Baseline in Insulin (Week 8).|The change between the value of insulin collected at week 8 and insulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a Insulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160477|NCT00286442|Secondary|Change From Baseline in Insulin (Week 4).|The change between the value of insulin collected at week 4 and insulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an insulin measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||mcIU/mL||Standard Error|Least Squares Mean
160478|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 26).|The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a PROINSULIN measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160479|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 20).|The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160480|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 16).|The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160481|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 12).|The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160482|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 8).|The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a proinsulin measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
163613|NCT00247611|Secondary|Viral Load Count|Viral load data extracted from medical records beginning 30 days prior to baseline.|Measured over 18 months|||percentage with undetectable viral load|||Number
160483|NCT00286442|Secondary|Change From Baseline in Fasting Proinsulin (Week 4).|The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||pmol/L||Standard Error|Least Squares Mean
160484|NCT00286442|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.||participants|||Number
160485|NCT00286442|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.||participants|||Number
160486|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160487|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160488|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160489|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160490|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160491|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2. Missing data imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160492|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 2.||mg/dL||Standard Error|Least Squares Mean
160493|NCT00286442|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had a fasting plasma glucose measurement at baseline and at Week 1.||mg/dL||Standard Error|Least Squares Mean
160494|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 20.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160495|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 16.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160496|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 12.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160497|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 8.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160498|NCT00286442|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160499|NCT00286442|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized participants who received at least 1 dose of study drug (Full Analysis Set), and who had an HbA1c measurement at baseline and at Week 26.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160500|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 26).|The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160501|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 20).|The change between Body Weight measured at week 20 and Body Weight measured at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160502|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 12).|The change between Body Weight measured at week 12 and Body Weight measured at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160503|NCT00286429|Secondary|Change From Baseline in Body Weight (Week 8).|The change between Body Weight measured at week 8 and Body Weight measured at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||kg||Standard Error|Least Squares Mean
160504|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.~Due to no participants in the placebo arm achieved HbA1c decrease from baseline ≥2.0%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."||participants|||Number
160505|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
160506|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
160507|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.|The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
160508|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
160509|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 HbA1c measurement after baseline.||participants|||Number
160510|NCT00286429|Secondary|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.|The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.|Baseline and Week 26.|"Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 HbA1c measurement after baseline.~Due to no participants in the placebo arm achieved HbA1c ≤ 6.5%, the odds ratio of alogliptin to placebo and 95% CI were not estimable from the logistic regression."||participants|||Number
160511|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 26).|The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160546|NCT00284739|Secondary|Duration (in Days) of Percutaneous Drainage.|The total number of days that the drainage catheter was left in place from the time of randomization until the time of catheter removal. The maximum duration of measurement for this outcome was up to 30 days.|Up to 30 days|||days||95% Confidence Interval|Mean
160512|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 20).|The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160513|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 16).|The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160514|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160515|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 8).|The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160516|NCT00286429|Secondary|Change From Baseline in C-peptide (Week 4).|The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||ng/mL||Standard Error|Least Squares Mean
160517|NCT00286429|Secondary|Number of Participants Requiring Rescue.|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who completed at least 1 study visit after baseline.||participants|||Number
160518|NCT00286429|Secondary|Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).|The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.|26 Weeks.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had at least 1 fasting plasma glucose measurement after baseline.||participants|||Number
160519|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 26).|The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160520|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160521|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160522|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160523|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160524|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160525|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 2. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160526|NCT00286429|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 1).|The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.|Baseline and Week 1.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 1. Missing data are imputed using last observation carried forward (LOCF).||mg/dL||Standard Error|Least Squares Mean
160527|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 20.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 20. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160528|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 16.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 16. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160529|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 12.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 12. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160530|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 8.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 8. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160531|NCT00286429|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 4.|Randomized participants who received at least 1 dose of study drug and who had an HbA1c measurement at baseline and at Week 4. Missing data are imputed using last observation carried forward (LOCF).||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160532|NCT00286429|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 26.|Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at Week 26. Missing data are imputed using last observation carried forward (LOCF). ANCOVA = Analysis of covariance.||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
160533|NCT00286325|Secondary|B Cell Number at Week 24|Peripheral blood B cell number at week 24 compared to B cell number at week 0|Week 0 and at 24 weeks|excluded subject with epidermolysis bullosa acquisita diagnosed after study entry||B cells per microliter||Full Range|Median
160534|NCT00286325|Secondary|IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24.|IgG antibodies against BP 180 measured in units (by ELISA) for each participant at week 0 compared to value at week 24,|Week 0 and at 24 weeks|Excluded subject with diagnosis of epidermolysis bullosa acquisita made after study entry, excluded one subject with no circulating antibodies measured at either time point.||Elisa Units||Full Range|Median
160535|NCT00286325|Secondary|Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24|Subject systemic corticosteroid dosage at week 24 was 25% of starting dose or 10 mg/day of prednisone or less|24 weeks|Excluded subject with epidermolysis bullosa acquisita diagnosed after study entry.||participants|||Number
160536|NCT00286325|Primary|Primary Safety Endpoint|The primary safety endpoint is the occurrence of treatment emergent adverse events including infections, infusion reactions and disease progression. These were determined by clinical evaluation and laboratory questions. Disease progression is defined as development of new blisters despite therapy. These are reported as the number of participants with a study related SAE.|1 year|The safety analysis was performed on all subjects||participants|||Number
160537|NCT00286325|Secondary|Number of Days to Cessation of New Blister|The first study visit in which patient reported and was confirmed to have no new blister or lesion formation .|1 year|Excluded subject with diagnosis of epidermolysis bullosa acquisita , made after study entry.||Days||Full Range|Median
160538|NCT00286182|Primary|Change in Left Ventricular End-diastolic Volume|This outcome measure is collected using a three dimensional echocardiography.|Baseline and 6 month|||mL||Standard Error|Mean
160539|NCT00286156|Secondary|Change in Total Kidney Volume as Measured by 3D-CT From Baseline to 12 Months|Total kidney volume measured by CT from baseline to 12 months|From baseline to 12 months|||ml||Standard Deviation|Mean
160540|NCT00286156|Primary|Change in GFR From Baseline to 12 Months|GFR (glomerular filtration rate) was measured by iothalamate. GFR is a key indicator of renal function.|From baseline to 12 months|||ml/min/1.73m^2||Standard Deviation|Mean
160541|NCT00286091|Secondary|Overall Survival|Time from randomization to the date of death. Participants who were still alive or lost to follow-up by the primary analysis data cut-off date were censored at their last contact date (on-study or during survival follow-up) or the primary analysis data cut-off date, whichever was first.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set||days||95% Confidence Interval|Median
160542|NCT00286091|Secondary|Time to First Bone Metastasis|Time from randomization to the date of first occurrence of bone metastasis (either symptomatic or asymptomatic), excluding death. Participants who did not develop bone metastasis were censored at their last on-study bone assessment date or the primary analysis data cut-off date, whichever was first. Median time to first bone metastasis was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set||days||95% Confidence Interval|Median
160543|NCT00286091|Primary|Bone Metastasis-free Survival|The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.|From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.|Full analysis set (all randomized participants)||days||95% Confidence Interval|Median
160547|NCT00284739|Secondary|Percentage of Loculated Abscesses Which Completely Resolve With Percutaneous Drainage Alone at the First Follow-up CT Scan Performed 3 Days After Initial Drain Placement|This is the percentage of participants in whom their loculated abscess completely resolve with percutaneous drainage at the time of the first followup CT performed at 3 days after start of the intervention and therefore do NOT require additional surgical intervention.|3 days|||percentage of patients|||Number
160548|NCT00284739|Primary|Percentage of Patients Requiring Surgical Debridement for a Persistent Abscess Within 30 Days Following Initial Drainage||30 days|||participants|||Number
160549|NCT00285818|Primary|Hamilton Depression Rating Scale Score|The Hamilton Depression Scale measures the severity of depression. There are 17 items rated 0 to 4. A total score of 0 indicates that the patient does not endorse any symptoms of depression. The maximum score (the most severe depression) is 68. The outcome measure is the difference between Visit 1 and Visit 4 Hamilton Depression Rating Scale scores of the mifepristone and placebo groups.|Screening to Final Visit|||units on a scale||Standard Deviation|Mean
160550|NCT00285779|Secondary|The Percentage of Placebo and Study-drug Patients Able to Discontinue Use of Topical Corticosteroids Through Week 24||24 weeks||||||
160551|NCT00285779|Secondary|"The Percentage of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of Clear) at 12 Weeks"||12 weeks||||||
160552|NCT00285779|Secondary|The Number and Percentage of Subjects Experiencing Serious Adverse Events (SAE) on Etanercept and Placebo||12 and 24 weeks||||||
160553|NCT00285779|Secondary|Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks||12 and 24 weeks||||||
160554|NCT00285779|Secondary|Patient Assessment of Pruritus/Itching on a Visual Analogue Scale (VAS) at 12 and 24 Weeks||12 and 24 weeks||||||
160555|NCT00285779|Secondary|Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks||12 and 24 weeks||||||
160556|NCT00285779|Secondary|The Individual and Total Cutaneous Target Lesion Scores at 12 and 24 Weeks||12 weeks and 24 weeks||||||
160557|NCT00285779|Secondary|The Physician Assessment of Surface Area of Disease, PSAD, (Mucosal Erosions and Cutaneous Disease) at 12 and 24 Weeks||24 weeks||||||
160558|NCT00285779|Secondary|The Percentage of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks||24 weeks||||||
160559|NCT00285779|Primary|The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks|This is a physician global assessment of disease (0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease). The subject have a level >=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.|12 weeks|Intention to treat analysis (all participants received at least one dose of study drug). Missing data imputed using Last Observation Carried Forward (LOCF).||percentage of participants|||Number
160560|NCT00285584|Secondary|Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.|The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment|Month 6 compared to enrollment (Month 0)|||units on a scale||Full Range|Median
160561|NCT00285584|Secondary|Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)|Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.|Enrollment to Month 6|Self-reported and laboratory identified sexually transmitted infections||participants|||Number
160562|NCT00285584|Secondary|Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.|Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.|Month 6 compared to Month 0 (enrollment)|All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6||Drug-using occasions per month||Full Range|Median
160563|NCT00285584|Primary|The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.|The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.|Enrollment to Month 6|Subjects remaining in study through 6-Month study visit.||Sexual partners||Full Range|Median
160564|NCT00285467|Secondary|Systolic Blood Pressure at 3 Months|systolic blood pressure at 3 months|3 month|||mmHg||Standard Deviation|Mean
160565|NCT00285467|Primary|Percent Reduction in PTH|Percent reduction in PTH from baseline to 3 months|3 month|The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.||% change in PTH baseline to 3 months||Standard Deviation|Mean
160566|NCT00285246|Primary|Health Care Utilization|This variable is a sum score of the self-reported number of healthcare provider visits and emergency room visits in the prior 12 months.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on the healthcare utilization measure.||number of visits in prior 12 months||Standard Deviation|Mean
160567|NCT00285246|Primary|Mental Functional Status|Mental Component Summary Score (MCS) from the Veterans-RAND (VR) 36 (Kazis, 2000). MCS is a composite score with a mean of 50 and a standard deviation of 10. Scale scores range from 0-100 with higher scores reflecting better mental function.|pre-deployment, immediate post-deployment, 3 months post-return, 1 year post-return|Not all of the 790 completers has complete data on the mental functional status measure.||units on a scale||Standard Deviation|Mean
160568|NCT00285246|Primary|Physical Functional Status|Physical Component Summary Score (PCS) from the Veterans RAND (VR) 36 measure (Kazis, 2000). Composite scores are normed to a mean of 50 and a SD of 10. Scores can range from 0-100. Higher scores indicate better physical function.|pre-deployment (Phase 1), immediate post-deployment (Phase 2), 3 months post-return (Phase 3), 1 year post-return (Phase 4)|Not all of the 790 completers has complete data on this physical functional status measure.||Units on a scale||Standard Deviation|Mean
160569|NCT00285246|Primary|Non-Specific Physical Symptoms|Severity of non-specific physical symptoms from the 15 item Patient Health Questionnaire-15 (Kroenke, Spitzer & Williams, 2002). Scale score range is 0-30. Higher scores indicate greater non-specific physical symptom severity. This scale does not contain subscales.|pre-deployment (Phase 1), immediately post-deployment (Phase 2), 3 months post-return from deployment (Phase 3), 1 year post-return from deployment (Phase 4)|Not all of the 790 completers has complete data on the non-specific physical symptoms measure.||units on a scale||Standard Deviation|Mean
160570|NCT00285207|Secondary|Immunologic Parameters B/T Cells Will be Assessed by B/T Cell Profile Collection.||over the course of the trial||||||
160571|NCT00285207|Secondary|Eradication of Human Papilloma Virus (HPV) Will be Assessed by Way of Cervical Cytology and Swab Collection.||over the course of the trial||||||
160572|NCT00285207|Secondary|Local Tolerability and Systemic Safety of A-007 Will be Assessed by Way of CTCAE 3.0.||over the course of the trial||||||
160573|NCT00285207|Primary|Pathological Response|Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.|baseline and 4 months|||participants|||Number
160574|NCT00284180|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||percentage of participants||95% Confidence Interval|Number
160575|NCT00284154|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|All patients were assessed for progression free survival.||Months||95% Confidence Interval|Median
160576|NCT00284154|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Overall survival was measured from the date of study entry until the date of death.|18 months|All patients were assessed for overall survival.||Months||95% Confidence Interval|Median
160577|NCT00284154|Secondary|Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients’ Disease|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|All patients were assessed for response. Only patients with objective response were analyzed for response duration.||Months||95% Confidence Interval|Median
160578|NCT00284154|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.|18 months|All patients were assessed for response.||percentage of participants||95% Confidence Interval|Number
160579|NCT00284141|Secondary|Number of Participants With Anti-drug Antibodies|"Anti-drug antibodies in a participant's serum sample were assayed with an anti-drug ELISA assay, with a lower limit of quantitation of 238.4 ng/mL for an undiluted human serum sample.~Serum for anti-drug antibody analysis was collected pre-dose on every fourth cycle after Cycle 1 Day 1 (at 8 week intervals), at end of treatment (EOT), and during post-treatment follow-up 60 days after the last dose."|up to 2.5 years after initial treatment|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.||participants|||Number
160580|NCT00284141|Primary|Confirmed Objective Response Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Investigator.|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).~Assessments were made by the Investigator, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.||participants|||Number
160581|NCT00284141|Secondary|Free and VEGF-bound Trough Aflibercept Concentrations (VEGF Trap)|"Median free and VEGF-bound trough concentrations were determined at the end of each cycle beyond Cycle 2 (Steady-state) for each participant.~Plasma free aflibercept levels were estimated by a validated direct ELISA, with an LOQ of 15.6 ng/mL. Plasma VEGF-bound aflibercept levels were also estimated by a separate validated direct ELISA with an LOQ of 43.9 ng/mL.~Mean ± SD (coefficient of variation [CV%]) values were estimated from the median values calculated for each participant."|At the end of each treatment cycle (up to 2.5 years)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples on Day 1 of Cycle 3 for measurement of VEGF-bound aflibercept.||micrograms/mL||Standard Deviation|Mean
160582|NCT00284141|Secondary|Peak of Free Aflibercept (VEGF Trap)|Plasma free aflibercept levels after the first aflibercept infusion were estimated by a validated direct measured by enzyme-linked immunosorbent assay (ELISA), with a limit of quantification (LOQ) of 15.6 ng/mL.|Day 1 of the first infusion of Aflibercept (cycle 1)|All participants who received at least part of 1 dose of study treatment and had evaluable blood samples.||micrograms/mL||Standard Deviation|Mean
160583|NCT00284141|Secondary|Number of Participants With Laboratory Abnormalities|"Participants with abnormal laboratory results for~Liver and renal function (Alkaline phosphatase, Alanine aminotransferase [ALT], aspartate aminotransferase [AST], Creatinine, Hyperbilirubinemia),~Electrolytes (Hypercalcemia, Hypocalcemia, Hypokalemia, Hypernatremia, Hyponatremia, Hypophosphatemia)~Metabolism (Hypoalbuminemia, Hyperglycemia, Hypoglycemia)~Hematology (Partial thromboplastin time, Anemia, Lymphopenia, Neutropenia, Thrombocytopenia, Leukopenia)"|Up to 2.5 years|All participants who received at least part of 1 dose of study treatment.||Participants|||Number
165769|NCT00197392|Secondary|Number of Days With Indwelling Catheter|Days catheter was implanted in subjects|Implant of subjects to day of explant|||Days||Standard Deviation|Mean
160584|NCT00284141|Secondary|Overall Safety - Number of Participants With Adverse Events|All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 60 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.|up to 60+/-5 days after treatment discontinuation, or or until TEAE was resolved or stabilized (Collected till 18 July 2008)|All participants who received at least part of 1 dose of study treatment.||participants|||Number
160585|NCT00284141|Secondary|Heath-related Quality of Life (QOL) Measured Via the Lung Cancer Subscale|"HRQL was assessed with the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, which was completed by the participants on Day 1 of Cycle 1 only (for baseline value), then on Day 14 of each even-numbered cycle to evaluate the participants symptoms.~The questionnaire scored 7 symptoms: shortness of breath, weight loss, clarity in thinking, coughing, appetite, chest tightness, ease of breathing, on a 0-4 scale. The total FACT-LCS score ranged from 0-28 (where 28 was related to the worst outcome). To calculate a change, the baseline score was subtracted from the score obtained after treatment. A negative value implied an improvement in HRQL."|Baseline to 2.5 years|All registered participants with available questionnaires at the timepoint assessed.||score on a scale||Standard Deviation|Mean
160586|NCT00284141|Secondary|Overall Survival (OS)|"OS was the time interval between registration to the date of death from any cause. The median time for OS was estimated from Kaplan-Meier Plots.~A participant was to be censored for the OS analysis if the participant was alive by the study cut-off date. The censoring date was either the date that the participant was last known to be alive or the date of study cut-off, whichever came earlier."|up to 2.5 years from initial treatment|All registered participants. 38 participants were censored for OS.||months|Participants|95% Confidence Interval|Median
160587|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Investigator|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors."|up to 2.5 years from initial treatment|All registered participants. 17 participants were censored.||weeks|Participants|95% Confidence Interval|Median
160588|NCT00284141|Secondary|Progression-free Survival (PFS) Time Assessed by the Independent Review Committee (IRC)|"PFS time was interval from the date of registration to the date of tumor progression (by RECIST or modified RECIST), or death from any cause, whichever was earlier. Median PFS time was estimated from Kaplan-Meier Plots.~Progression was at least a 20% increase in the sum of the longest diameter (LD) of tumors, compared to smallest sum LD recorded since treatment started, or the appearance of one or more new tumors.~If a participant did not progress or die, the date was censored to the date of last valid tumor assessment or the date of data cut-off, whichever was earlier."|up to 2.5 years from initial treatment|All registered participants. 18 participants were censored.||weeks|Participants|95% Confidence Interval|Median
160589|NCT00284141|Secondary|Duration of Response (DR)|DR was the time interval from the first complete response (CR) or partial response (PR) to the date of tumor progression or death from any cause, whichever was earlier. The duration of response was calculated only for those participants who achieved CR or PR.|up to 2.5 years from initial treatment|No modified RECIST responses, as confirmed by the IRC review, were observed. Only 2 responders were reported by the Investigators. Therefore, the analyses for duration of response was not performed.|||||
160590|NCT00284141|Primary|Confirmed Objective Response (OR) Based Upon Modified Response Evaluation Criteria in Solid Tumors (RECIST) Assessed by the Independent Review Committee (IRC).|"OR was either complete response (CR) or partial response (PR) based on RECIST or modified RECIST. CR was the disappearance of all target/nor-target lesions; and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with reference to the baseline sum LD (According to modified RECIST, to calculate LD for cavitated lesions, the longest cavitation diameters were subtracted from the LD of cavitated target lesions).~Assessments were made by the IRC, and confirmed by repeat tumor imaging 4-6 weeks after documentation of the initial response."|up to 2.5 years from initial treatment|Simon's cohort: The first 84 evaluable participants, based on Simon's two-stage study design that required 84 evaluable participants to maintain a targeted 90% power.||Participants|||Number
160591|NCT00284089|Secondary|Mean Change From Baseline in Total Retinal Volume of the Study Eye in Group B|Total retinal volume was assessed by Optical Coherence tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|OCT was performed in a total of 58 patients at selected sites. Group B Intent-to treat (ITT) population, observed data only are included. The assessed sample size was small for total retinal volume data because the central reading center judged “Can not grade” due to retinal pigment epithelium disruption associated with CNV secondary to AMD.||micrometers||Standard Deviation|Mean
160592|NCT00284089|Secondary|Mean Change From Baseline in Foveal Retinal Thickness of the Study Eye in Group B|Foveal retinal thickness was assessed by Optical Coherence Tomography (OCT) at a subset of the study sites and was analyzed by the central reading center.|Baseline, Months 3, 6, 9 and 12|The analysis includes Group B Intent-to treat (ITT) population, observed data. OCT was performed in a total of 58 patients at selected sites.||micrometers||Standard Deviation|Mean
160593|NCT00284089|Secondary|Percentage of Participants in Group B With Absence of Leakage in the Study Eye at Month 3, 6, 9 and 12.|Area of leakage was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed at the central reading center.|Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and for whom data was available. The Last Observation Carried Forward (LOCF) was used to impute missing data.||Percentage of participants|||Number
160638|NCT00283842|Primary|Change in Mean Pain Severity Score From Baseline to 13 Weeks|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.|Baseline and 13 weeks|The analysis population was the intent to treat.||units on scale||Standard Error|Mean
160594|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Leakage From CNV Plus Staining of Retinal Pigment Epithelium of the Study Eye in Group B|Area of leakage from CNV plus staining of retinal pigment epithelium was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The total area is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.||disc areas||Standard Deviation|Mean
160595|NCT00284089|Secondary|Mean Change From Baseline in Total Area of Choroidal Neovascularization of the Study Eye in Group B|Choroidal Neovascularization was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center. The area of Choroidal Neovascularization is expressed as Macular Photocoagulation Study standard Disc Areas (DA; equivalent to 2.54 mm^2 on the retina).|Baseline, Months 3, 6, 9 and 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment. The Last Observation Carried Forward (LOCF) was used to impute missing data.||disc areas||Standard Deviation|Mean
160596|NCT00284089|Secondary|Extension Phase: Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Last Visit of Extension Phase in Group B|"BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The following categories were evaluated:~Participants with a BCVA score loss of fewer than 15 letters from baseline at Last Visit~Participants with a BCVA score loss of 30 or more letters from baseline at Last Visit~Participants with a BCVA score gain of 15 or more letters from baseline at Last Visit~Participants with a BCVA score of less than 34 letters at Last Visit"|Baseline and last visit of extension phase - Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|Includes patients enrolled in the extension phase, observed data.||Participants|||Number
160597|NCT00284089|Secondary|Extension Phase: Mean Change From Month 12 (Start of Extension Phase) in Best Corrected Visual Acuity Score of the Study Eye at Last Visit of Extension Phase in Group B.|Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Month 12 (start of extension phase) and last visit of extension phase. Duration in the extension phase varied depending on the study entry. The mean duration of treatment was 1.45 years in the 0.3 mg group and 1.36 years in the 0.5 mg dose group.|The analysis population included all enrolled patients in the extension phase. For the analysis of the results of the extension phase, all data are presented as observed. Patients must have values both at Month 12 and Last Visit to be included.||Letters||Standard Deviation|Mean
160598|NCT00284089|Secondary|Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Month 6 and Month 12 in Group B|BCVA measurements were taken in a sitting position using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters.|Baseline, Month 6 and Month 12|ITT population, using LOCF.||Participants|||Number
160599|NCT00284089|Secondary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 12 in Group B|The efficacy assessment was based on Group B patients. BCVA was assessed during all study visits using best correction determined from protocol refraction and ETDRS-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 12|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the efficacy variable. The Last Observation carried Forward (LOCF) was used to impute missing data at month 12 in the ITT analysis.||Number of Letters||Standard Deviation|Mean
160600|NCT00284089|Primary|Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 6 in Group B|The efficacy assessment was based on Group B patients. Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 2 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 2 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline and Month 6|Intent-to treat (ITT) population for Group B patients consisted of all patients randomized in Group B that received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. The Last Observation Carried Forward (LOCF) was used to impute missing data at month 6 in the ITT analysis.||Number of Letters||Standard Deviation|Mean
160601|NCT00285012|Secondary|Change From Baseline in Body Weight|Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).|Baseline, Week 52|Subjects with change in body weight in the All subjects population||kg||Standard Deviation|Mean
160602|NCT00285012|Secondary|Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen|Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl).|Baseline, Week 12, Week 52|All subjects population; (n) = number of subjects with analyzable data at observation for varenicline and placebo, respectively.||mg/dl||Standard Deviation|Mean
160603|NCT00285012|Secondary|Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period|Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.|Day 1 through Day 21|All subjects population; (n) = number of subjects who smoked at least 1 cigarette at the given day for varenicline and placebo, respectively.||cigarettes per day||Standard Deviation|Mean
160639|NCT00283816|Secondary|Change in Sex Hormone Binding Globulin (SHBG)|SHBG concentration post minus pre-intervention|baseline and 24 weeks|||nmol/L||Standard Deviation|Mean
160604|NCT00285012|Secondary|Change From Baseline in Clinical COPD Questionnaire (CCQ)|Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit.|Baseline, Week, 12, Week 24, Week 52|All subjects; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively.||scores on scale||Standard Deviation|Mean
160605|NCT00285012|Secondary|Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)|Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol.|Baseline, Week 12, Week 52|All subjects population; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively. Missing data imputed by carrying the last observation forward (LOCF), including baseline values.||ml||Standard Deviation|Mean
160606|NCT00285012|Secondary|Number of Subjects With 4-Week Point Prevalence of Abstinence|Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All subjects population||particpants|||Number
160607|NCT00285012|Secondary|Number of Subjects With 7-Day Point Prevalence of Abstinence|Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit.|Week 12, Week 24, Week 52|All subjects population||participants|||Number
160608|NCT00285012|Secondary|Number of Subjects With Long Term Quit Rate (LTQR)|"Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52).~CO confirmed in-clinic visit."|Week 24, Week 52|All subjects population||participants|||Number
160609|NCT00285012|Secondary|Number of Subjects With Continuous Abstinence (CA)|Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit.|Week 9 through Week 24 and Week 52|All subjects population||participants|||Number
160610|NCT00285012|Primary|Number of Subjects With Four Week Continuous Quit Rate (CQR)|Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory [NUI]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).|Week 9 through Week 12|All subjects population: received at least 1 dose, including partial doses, of randomized study drug.||participants|||Number
160611|NCT00284934|Secondary|Number of Participants With Graft and Patient Survivals at 6 Months|Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||Participants|||Number
160612|NCT00284934|Secondary|Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months|A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|6 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||Participants|||Number
160613|NCT00284934|Secondary|Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)|Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and 3 months|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||mL/min/1.73m^2||Standard Deviation|Mean
160614|NCT00284934|Primary|Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)|Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where -C is the serum concentration of creatinine [mg/dL], -A is patient age at sample collection date [years], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.|Baseline and Month 6|Intent-to-treat (ITT) population was defined as all patients who were randomized and treated with study medication and had at least one post-treatment efficacy assessment.||mL/min/1.73m^2||Standard Deviation|Mean
160640|NCT00283816|Secondary|Total Testosterone Change|Change in total testosterone post minus pre intervention|baseline and 24 weeks|||ng/dL||Standard Deviation|Mean
160641|NCT00283816|Secondary|Change in Weight Post Minus Pre Intervention.|Body mass index change in adolescents enrolled in lifestyle intervention program|baseline and 24 weeks|||kg/m^2||Standard Deviation|Mean
160642|NCT00283816|Primary|Reduction in Abdominal Fat as Measured by Waist Circumference.|Change in waist circumference measured in cms used as a measure of abdominal adiposity, pre minus post intervention|baseline and 24 weeks|||cm||Standard Deviation|Mean
160615|NCT00284856|Secondary|Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period|PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.||Liters/minute||Standard Deviation|Mean
160616|NCT00284856|Secondary|Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period|4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score.|Baseline and 6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint.||Score on a scale||Standard Deviation|Mean
160617|NCT00284856|Primary|Percentage of Asthma-control Days Over the 6-month Treatment Period|An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.|6 months|Efficacy analysis was based on the full analysis set (FAS) population which included all participants who had at least 7 days of on-treatment data for the specific endpoint. Thirty three patients were excluded from the FAS (13 on montelukast, 7 on fluticasone and 13 on placebo). One participant in the placebo group did not take study medication.||Percentage of days||Standard Deviation|Mean
160618|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 12-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|12-months post-intervention|||Z-score||Standard Deviation|Mean
160619|NCT00284557|Secondary|"Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and Screen Time"||6- and 12-months post-intervention||||||
160620|NCT00284557|Primary|BMI Z-score(for Gender and Age)at 6-months|The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.|6-months post-intervention|||Z-score||Standard Deviation|Mean
160621|NCT00284518|Post-Hoc|Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers|The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.||Score on a scale||Standard Deviation|Mean
160622|NCT00284518|Other Pre-specified|Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain|The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||Score on a scale||Standard Deviation|Mean
160623|NCT00284518|Secondary|Change From Baseline in Post-Void Residual|Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.|Baseline, Week 2, Week 12, Week 72|Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.||milliliters (mL)||Standard Deviation|Mean
160624|NCT00284518|Secondary|Change From Baseline in Transitional Zone Prostate Volume|Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||milliliters (mL)||Standard Deviation|Mean
160625|NCT00284518|Secondary|Change From Baseline in Total Prostate Volume|Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||milliliter (mL)||Standard Deviation|Mean
160626|NCT00284518|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.|Baseline, Week 12, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||milliliters (mL)/second||Standard Deviation|Mean
165771|NCT00197392|Secondary|Intraluminal Colonization on Catheters|Number of catheters with Bacterial colonization verified using fluorescence.|Implant of subjects to post implant|||catheters|||Number
160627|NCT00284518|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 72|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||Score on a scale||Standard Deviation|Mean
160628|NCT00284518|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.||Score on a scale||Standard Deviation|Mean
160629|NCT00284050|Secondary|Mean Change From Baseline in Central Retinal Thickness (µm) of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was assessed on both eyes at every study visit. These assessments were performed by trained personnel at the sites. OCT imaging was performed using the Zeiss Humphrey System Model 2000 (or later) with version A6.1 software running under Windows 95 or Windows 98. The analysis of the OCT images were performed by the Photographic Reading Center which provided a study manual and training materials. OCT operators, systems and software were certified prior to any evaluation of study patients.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.||µm||Standard Deviation|Mean
160630|NCT00284050|Primary|Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.||Letters||Standard Deviation|Mean
160631|NCT00284050|Primary|Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters as described in the Study Operations Manual.|Baseline through the end of study (Month 12)|Full Analysis Set (FAS): All patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. A Last Observation Carried Forward (LOCF) approach was used; missing values were replaced by the mean of the last observation before and the first observation after the missing time-point.||Letters||Standard Deviation|Mean
160632|NCT00283868|Secondary|Percentage of Evaluations With Technical Observations|Technical Observations: This measure was designed to assess the percentage of evaluations where there were technical observations (difficulties with using the technology) noted by the consultant who performed the evaluation (either telemedicine evaluation or telephone evaluation) in each arm of the trial.|Time of consultation|||Percentage of Evaluations|||Number
160633|NCT00283868|Secondary|Time to Treatment Decision for Administration of Thrombolytics|time to decision (consult onset to decision). This measure was meant to assess how long it took to do the evaluation.|potentially within 3 hours of symptom onset|||Minutes||Standard Deviation|Mean
160634|NCT00283868|Secondary|Percentage of Total Thrombolytic Administrations|This measure assesses the number of total thrombolytic administrations that were given. This was to measure whether there were more participants treated with thrombolytics in one arm of the trial or the other.|potentially within 3 hours of symptom onset|||Percentage of participants|||Number
160635|NCT00283868|Secondary|Percentage of Participants With Intracerebral Hemorrhage (ICH)|Intracerebral Hemorrhage (ICH) rate at 36 hours. This was assessed by determining whether there was an intracerebral hemmorhage via telephone contact to the hospital where the patient was located. Any follow up imaging (head CT or MRI) was reported to the investigator team for presence of hemorrhage.|36 hours|||Percentage of participants|||Number
160636|NCT00283868|Primary|Appropriateness of Decision to Treat or Not Treat With Thrombolytics|"This primary measure assesses the appropriateness of decision to treat or not treat with thrombolytics for patients presenting potentially within 3 hours of symptom onset.~Appropriateness was assessed using a centralized adjudicating committee, 3 levels of data availability, and an independent medical monitor assessment. The case was presented to the adjudicating committee (blinded to randomization arm) and the committee reviewed patient records (also blinded to randomization arm) to assess whether decision was appropriate to give or not give rt-PA."|potentially within 3 hours of symptom onset|Of the original 234 patients, 11 were run in patients and were not randomized and 1 was removed from any analysis due to a protocol violation resulting in the total 222 patients analyzed. There were 7 lost to follow up in telemedicine and 8 lost to follow up in telephone resulting in 104 analyzed in telemedicine and 103 analyzed in telephone.||percentage of participants|||Number
160637|NCT00283842|Secondary|Number of Patients With ≥50% Reduction in Mean Pain Severity Score.|Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.|Baseline and 13 weeks|The analysis population is the intent to treat.||patients|||Number
168716|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48|||L||Standard Error|Mean
160643|NCT00283712|Secondary|Participant Pemphigus Vulgaris Disease Activity Score|The Pemphigus Vulgaris Disease Activity (PVDA) score was used to grade a participant’s disease activity using the SAGE II computerized burn mapping system, which calculated the total body surface area (BSA) involved. Scores were based on the number of new lesions and blisters present, old lesion history and BSA involved. Scores range from 0 to 3 (none to severe disease activity). A new disease activity score of 3 or an old lesion score of 3 indicates active disease. New disease activity scores of 3 for a 1-month duration or an old lesion score of 3 for 2 consecutive months was cause for removal from the study treatment|Baseline to Week 26|Safety Population||Participants|||Number
160644|NCT00283712|Secondary|Adverse Events Resulting in Treatment Discontinuation|Adverse events experienced by participants resulting in study treatment discontinuation and assessed by the investigators as at least possibly related to treatment (i.e., possibly, probably, definitely) were assessed.|Baseline to Week 26|Safety Population||Participants|||Number
160645|NCT00283712|Secondary|Participants Who Experienced Severe Infectious Complications|Serious and life-threatening infections of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population||Participants|||Number
160646|NCT00283712|Secondary|Participants Who Experienced Severe Infusion Reactions|Participants who experienced severe infusion reactions of Grade 3 or greater based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 were assessed.|Baseline to Week 26|Safety Population||Participants|||Number
160647|NCT00283712|Secondary|Participant Duration of Clinical Response|The primary efficacy endpoint of response to treatment at Week 18 was reassessed at study weeks 22 and 26 for participants who were responders at Week 18. Participants classified as responders had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. had no new blisters within the previous 4 weeks.|Baseline to Week 26|Participants in the Intent-to-Treat Population Who Were Responders at Week 18||Participants|||Number
160648|NCT00283712|Secondary|Participant Dermatology-Related Quality of Life Changes From Baseline to Week 18|The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire with a weighted value to each question. The DLQI score was calculated by summing the score of each question, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the greater quality of life is impaired. Change from baseline values (defined as the visit value - baseline value) were calculated. A negative change indicates better quality of life; a positive change indicates poorer quality of life.|Baseline to Week 18|Intent-to-Treat with available data||units on a scale||Standard Deviation|Mean
160649|NCT00283712|Secondary|Participant Health Related Quality of Life (Medical Outcome Study Short Form 36) Score Changes From Baseline to Week 18|The Medical Outcome Study Short Form 36 (MOS SF-36) measures health -related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from baseline is computed as the value at Week 18 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value worsening.|Baseline to Week 18|Intent-to-Treat with available data||units on a scale||Standard Deviation|Mean
160650|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve 80% Healing of Existing Erosions|Each participant’s prednisone dose was summed from the time of enrollment until the date of 80% healing of existing erosions. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Erosion Healing||mg||Standard Deviation|Mean
160651|NCT00283712|Secondary|Total Prednisone Dosage Required for Participants to Achieve Cessation of New Blisters|Each participant’s prednisone dose was summed from the time of enrollment until the date of cessation of new blisters. Actual prednisone use per day was computed as the average over all days in the week.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Cessation||mg||Standard Deviation|Mean
160652|NCT00283712|Secondary|Time to 80% Lesion Healing|Time to 80% healing of existing erosions/ulcerations at time of enrollment was assessed using the SAGE II computerized burn-mapping system. The date of 80% healing of existing erosions/ulcerations at time of enrollment was defined as follows: the first date at which the percent of total body surface area (BSA) involved is at least 80% less than the percent of total BSA calculated at the time of enrollment, where the baseline percent of total BSA must be greater than zero percent. If a participant had missing post-baseline assessments, their data was censored at their last non-missing assessment date.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Lesion Healing||Days||Standard Deviation|Mean
160653|NCT00283712|Secondary|Participant Time to Cessation of New Blisters|Time to cessation of new blisters was defined as the time from a participant's first treatment infusion date to the first date where that date and all subsequent dates had no new blisters. Participant diaries were used to assess new blister formation. To achieve cessation, participants had to be free of new blisters at least 3 weeks prior to their last assessment. In order to analyze missing or incomplete data, the data was censored at the date where a participant had no more data or on the date where 50% of the participant’s data was missing past that point.|Baseline to Week 26|Subset of Intent-to-Treat Who Experienced Cessation||Days||Standard Deviation|Mean
160654|NCT00283712|Secondary|Participant Modified Response Status at Week 18|Modified responder status was defined as participants achieving a prednisone dosage <=25% of the initial starting dose or <=10 mg/day (whichever is greater) at Week 18 regardless of status on new blister formation during the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat||Participants|||Number
160655|NCT00283712|Secondary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <=10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Per-protocol||Participants|||Number
160701|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 52|||participants|||Number
160656|NCT00283712|Primary|Treatment-Related Adverse Events >= Grade 3 On or Before Week 18|Grades were based on the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0. An adverse event (AE) was considered treatment-related if it was classified as unlikely, possibly, probably, or definitely related to study treatment. Participants who experienced at least one treatment-related, grade 3 or higher AE were counted only once. AEs of skin including rash, skin ulceration, and chelitis as defined by the NCI-CTCAE V3.0 System Organ Class of “Skin and Subcutaneous Tissues Disorders” were excluded.|Baseline to Week 18|Safety Population||Participants|||Number
160657|NCT00283712|Primary|Participant Response to Treatment at Week 18|Participants classified as responders at Week 18 had: 1. Achieved a prednisone dosage <= 25% of the initial starting dose or <= 10 mg/day (whichever is greater), and 2. Had no new blisters within the previous 4 weeks.|Baseline to Week 18|Intent-to-Treat||Participants|||Number
160658|NCT00283686|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat.||annual change in units on a scale||95% Confidence Interval|Mean
160659|NCT00283686|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)|baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Analysis using intention to treat||annual change in units on a scale||95% Confidence Interval|Mean
160660|NCT00283686|Secondary|All-Cause Hospitalizations||Up to 96 months|Intention to treat analysis: All participants who were randomized.||events|||Number
160661|NCT00283686|Secondary|Renal Blood Flow|renal blood flow (mL/min/1.73 m^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI).|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat analyses for participants with at least one valid renal blood flow measure.||annual change in mL/min/1.73 m^2||95% Confidence Interval|Mean
160662|NCT00283686|Secondary|Left Ventricular Mass Index|Left ventricular mass index (g/m^2) measured by MRI, centrally reviewed and measured|0, 24 months, 48 months, 60 months|Analyses were conducted using intention to treat for participants with at least one left ventricular mass index measure.||annual change in g/m^2||95% Confidence Interval|Mean
160663|NCT00283686|Secondary|Aldosterone|Urinary aldosterone excretion, centrally processed, 24 hour urine collection|Up to 96 months (assessed annually)|Analysis using intention to treat||annual % change micrograms per 24 hr||95% Confidence Interval|Mean
160664|NCT00283686|Secondary|Albuminuria|Urine albumin excretion, centrally processed from 24 hour urine collection|Up to 96 months (assessed annually)|Analysis by intention to treat||annual percent change in mg/24 hr||95% Confidence Interval|Mean
160665|NCT00283686|Secondary|Kidney Function (eGFR)|The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements.|Up to 96 months (6 month assessments)|Analyses were intention to treat: All participants who were randomized.||ml/min/1.73/m2/yr||95% Confidence Interval|Mean
160666|NCT00283686|Primary|Study A: Percent Annual Change in Total Kidney Volume|Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up.|Baseline and 2-, 4- and 5-year follow-up|Analyses were conducted on all participants who had at least one total kidney volume measurement using intention to treat.||percentage of Total Kidney Volume||95% Confidence Interval|Mean
160667|NCT00283595|Secondary|IGF-1 Level|Change in IGF-1 level between baseline and 12 weeks|Baseline, 12 Weeks|The analysis group consisted of individuals who completed study visits after the baseline visit. The three subjects who did not continue in the study discontinued their participation after the baseline visit.||ng/ml||Inter-Quartile Range|Median
160668|NCT00283595|Primary|Bone Metabolism|Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks|Baseline, 12 weeks|Only subjects who completed study visits after the baseline visit were included in the analysis. The three subjects who discontinued the study only completed a baseline visit and were therefore not included in the analysis.||ng/ml||Standard Error|Mean
160669|NCT00283439|Secondary|Percentage of Subjects That Received Platelet Transfusions|Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||Percentage of participants|||Number
160670|NCT00283439|Secondary|Duration of Grade 3 or 4 Thrombocytopenia|Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||Day||Standard Error|Mean
160671|NCT00283439|Secondary|Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia|Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L)|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||Percentage of participants|||Number
160672|NCT00283439|Primary|Change in Platelet Nadir|Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.|32 weeks|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol.||10^9/L||Standard Error|Mean
160673|NCT00283400|Secondary|Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1|Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1|3 months after enrollment|||participants|||Number
160674|NCT00283400|Secondary|Serious Adverse Events|"Serious adverse events included neurological and medical complications and neurological deterioration.~Neurological deterioration was defined as a decline by more than 2 points in the Glasgow Coma Scale."|within 3 months after enrollment|||participants|||Number
160889|NCT00282113|Primary|Weight Gain|Weight at five weeks minus birth weight|5 weeks|Infants left the study as they were discharged from the NICU, therefore many of the infants were not available for measurement at five weeks. The number reported is the number of infants remaining in the study at 5 weeks. Weight in grams is reported.||Grams||Standard Deviation|Mean
160675|NCT00283400|Primary|Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.|Tolerability outcome: Subject's ability to receive the full allocated human albumin dose without incurring frank congestive heart failure or experiencing anaphylactic reactions that required discontinuation of the treatment. Study would be terminated if 2 or more subjects developed severe or life-threatening heart failure considered to be related (probably, possibly, and definitely) to albumin treatment.|9 days after enrollment|Sample size consideration for this Phase I dose-escalation study was based on the feasibility of recruiting patients in a 3-year study period at 5 sites.The recruitment yield would be a maximum of 80 patients or 20 patients per dosage group. Statistical analyses were mainly descriptive.||participants|||Number
160676|NCT00283387|Primary|Urinary Oxalate Excretion|"The patients were randomly assigned oral betaine or placebo for 2 months, followed by a 2 month washout. Each patient then received the alternate study medication for 2 months.~Urinary Oxalate Excretion was measured by oxalate oxidase. Two 24 hour urine collections were obtained at baseline, and during the eighth week of each study period."|baseline, 2 months, 6 months|Per protocol analysis: 10 of 15 enrolled PHI subjects completed the study: 2 withdrew before initiation, 2 were noncompliant, in 1 symptoms led to withdrawal.||umol/mg||Standard Deviation|Mean
160677|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)|Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.|2 week in-home trial|Endeavor w/c||meters/day||Standard Deviation|Mean
160678|NCT00283296|Primary|Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)|Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.|2 week in-home trial|personal w/c||meters/day||Standard Deviation|Mean
160679|NCT00283296|Primary|Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle|Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.|immediately following course completion|||participants|||Number
160680|NCT00283075|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Dose limiting toxicity (DLT) was defined as:~any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;~any Grade ≥ 3 infection and~any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.~This definition of DLT is in accord with the NCI CTCAE v3.0."|6 months|||Participants who observed DLT|||Number
160681|NCT00283075|Other Pre-specified|Tumor Marker Response|Tumor marker response after the first implantation with RENCA macrobeads. Responders showed at least a 20% decrease from baseline in Cancer Antigen 19-9 (CA19-9) or Carcinoembryonic Antigen (CEA); Non-responders do not show at least a 20% decrease from baseline in CA19-9 or CEA.|Prior to Implantation and Day 7, Day 14, Day 21 and Day 28 after each implantation|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.||participants|||Number
160682|NCT00283075|Secondary|Overall Survival|Overall Survival (OS) was measured as date of first implantation to date of death of any cause, and was analyzed using the Kaplan-Meier method.|From date of RENCA macrobeads implantation until date of death from any cause|||months||95% Confidence Interval|Median
160683|NCT00283075|Primary|Maximum Tolerated Dose (MTD) of RENCA Macrobeads|"Dose limiting toxicity (DLT) was defined as:~any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction;~any Grade ≥ 3 infection and~any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction.~This definition of DLT is in accord with the NCI CTCAE v3.0.~Maximum tolerated dose (MTD) was to be identified if, within a cohort, > 1 subject out of the first 3, or 2 subjects out of 5 experienced DLT. In such a case, the MTD will have been exceeded, and the administration of the study agent was to cease. MTD would not be considered to have been reached if no DLTs were observed."|6 months|||RENCA Macrobeads/kg|||Number
160684|NCT00283062|Secondary|Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)|Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment.|from treatment initiation up to 19 months after treatment initiation|Safety population: all randomized participants who received any study drug||participants|||Number
160685|NCT00283062|Secondary|To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire|"The FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represents the best outcome.~Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size."|from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline)|QoL population: The subset of randomized participants who had an evaluable baseline questionnaire and at least one evaluable post-baseline questionnaire. A baseline QoL questionnaire was considered evaluable if it was filled out within 30 days prior to randomization, and no later than the date of randomization.||score on a scale||Standard Deviation|Mean
160686|NCT00283062|Secondary|Median Metastasis-free Survival (MFS)|"MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression.~Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median MFS was not to be performed as the study was underpowered.||participants|||Number
160890|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)||2 years|||participants|||Number
160687|NCT00283062|Secondary|Median Cancer-specific Survival (CSS)|"The CSS was the time from the date of surgery to the date of death due to prostate cancer.~Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated."|from the date of surgery up to 3 years after randomization of the last participant|Based on a protocol amendment, analysis for Median CSS was not to be performed as the study was underpowered.||participants|||Number
160688|NCT00283062|Secondary|Median Overall Survival (OS)|"Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause.~Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any drug.||participants|||Number
160689|NCT00283062|Primary|Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression|"PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of~first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks~date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm)~first radiological/ histological evidence of tumor progression~death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression."|from the date of surgery up to 3 years after randomization of the last participant|Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any study drug.||participants|||Number
160690|NCT00283049|Secondary|Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 Weeks from Baseline|Safety Population||events/ patient-year||Standard Deviation|Mean
160691|NCT00283049|Secondary|Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia|"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.~Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL~Severe hypoglycemia: assistance of another party is required & either:~SMBG of <36 mg/dL, or~with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.~Serious hypoglycemia:~Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."|60 weeks from Baseline|Safety Population||Participants|||Number
160692|NCT00283049|Secondary|Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||mg/dL||Standard Deviation|Mean
160693|NCT00283049|Secondary|Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||Percentage||Standard Deviation|Mean
160694|NCT00283049|Secondary|Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||Percent||Standard Deviation|Mean
160695|NCT00283049|Secondary|Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage||60 weeks from Baseline|The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.||Percentage|||Number
160696|NCT00283049|Primary|Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12||12 weeks from Baseline|Safety Population (excluding patients from Good Clinical Practice [GCP] non-compliant sites)||Percentage||Standard Deviation|Mean
160697|NCT00282984|Secondary|Number of Long-Term Quit Responders From Week 9 Through Week 24|Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 24|All Participants population||participants|||Number
160698|NCT00282984|Secondary|Cigarettes Smoked Per Day|Cigarettes smoked each day during the first 3 weeks of the treatment phase.|Day 21|All Participants population||cigarettes per day||Standard Deviation|Mean
160699|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 24|Responders: participants who remained abstinent based on ‘since the last contact’ question in Nicotine Use Inventory 1) “Has participant smoked any cigarettes (even a puff) since the last contact?” = No AND 2) “Has participant used any other tobacco products… since the last contact?” = No. Non- responder if the expired CO > 10 ppm at any given timepoint.|Week 9 through Week 24|All Participants population||participants|||Number
160700|NCT00282984|Secondary|Number of Participants With a 4 Week Point Prevalence of Smoking Cessation|Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two ‘last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.|Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])|All Participants population||participants|||Number
163676|NCT00246376|Primary|Total Cholesterol : HDL-C Ratio|Total cholesterol : HDL-C ratio: Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||ratio||Standard Error|Mean
160702|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 24|||participants|||Number
160703|NCT00282984|Secondary|Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12|Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) “Has the participant smoked any cigarettes in the last 7 days?” = No AND 2) “Has the participant used any other tobacco products in the last 7 days?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 12|All Participants population||participants|||Number
160704|NCT00282984|Secondary|Number of Long-Term Quit Responders|Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.|Week 9 through Week 52|All participants population||participants|||Number
160705|NCT00282984|Secondary|Number of Responders With Continuous Abstinence (CA) Through Week 52|Responders: participants who remained abstinent based on ‘since the last contact’ question in Nicotine Use Inventory 1) “Has participant smoked any cigarettes (even a puff) since last contact?” = No AND 2) “Has participant used any other tobacco products… since last contact?” = No. Participant a non-responder if expired CO > 10 ppm.|Week 9 through Week 52|All participants population||participants|||Number
160706|NCT00282984|Primary|Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)|Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint.|weeks 9 through 12|"Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as All Participants population in this report."||participants|||Number
160707|NCT00282971|Secondary|Change From Baseline in FEV1 at Week 24 LOCF||24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.FEV1=forced expiratory volume in 1 second;LOCF=last observation carried forward.||Liter||Standard Deviation|Mean
160708|NCT00282971|Secondary|Percentage of Participants Achieving Glycemic Control by Visit|2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. LOCF=last observation carried forward.||Percentage of participants|||Number
160709|NCT00282971|Primary|Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|[(week 24 value - baseline value)/baseline value]*100%|4, 12 and 24 weeks|Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.||percentage change||Standard Deviation|Mean
160710|NCT00282919|Secondary|Parasite Clearance Time|Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.|||||
160711|NCT00282919|Secondary|Fever Clearance Time|Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature).|Baseline up to Day 42|Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.|||||
160712|NCT00282919|Secondary|Percentage of Participants With Gametocyte Clearance|Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration. Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance. Percentage of participants with gametocyte clearance were reported.|Day 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."||percentage of participants||90% Confidence Interval|Number
160713|NCT00282919|Secondary|Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42|Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here “N” (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.|Day 7, 14, 21, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."||percentage of participants||90% Confidence Interval|Number
160714|NCT00282919|Secondary|Percentage of Participants With Clinical Cure|Clinical Cure is defined as resolution of the participant’s fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).|Day 3, 7, 28, and 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."||percentage of participants||90% Confidence Interval|Number
160738|NCT00281658|Secondary|Progression-free Survival|Progression-free survival is defined as the time from randomization until the earliest date of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause, if sooner during the randomized phase. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population||months||95% Confidence Interval|Median
160715|NCT00282919|Secondary|Percentage of Participants With Resistance to Treatment|Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia. Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack. Percentage of participants with resistance as measured by RI, RII and RIII is reported.|Days 7, 14, 21, 28, 35, 42|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point."||percentage of participants|||Number
160716|NCT00282919|Secondary|Percentage of Participants With Late Treatment Failures (LTF)|LTF included late clinical failure (LCF) and late parasitologic failure (LPF). LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF. LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."||percentage of participants||90% Confidence Interval|Number
160717|NCT00282919|Secondary|Percentage of Participants With Early Treatment Failures (ETF)|ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline).|Baseline up to Day 28|"Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure."||percentage of participants||90% Confidence Interval|Number
160718|NCT00282919|Primary|Percentage of Participants With Parasite Clearance at Day 28|Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28. Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance. Percentage of participants with clearance is reported. Here “N” (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.|Day 28|Parasitological per protocol (PP) population: Participants who had study drug for 3 days unless treatment failure, no concomitant anti-malarial unless designated treatment failure, had test of cure at Day 28, baseline smear with parasitemia between 1000-100000 parasites/microliter, rapid diagnostic test positive for P falciparum, history of fever.||percentage of participants||90% Confidence Interval|Number
160719|NCT00282867|Post-Hoc|Target Glucose Concentration|glucose in target range in first 24 hours|first 24 hours after initiation of treatment|"Per protocol no analysis of this endpoint was performed in the usual care group."||participants|||Number
160720|NCT00282867|Other Pre-specified|Symptomatic Hypoglycemia|symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period|up to 5 days|||participants|||Number
160721|NCT00282867|Primary|Hypoglycemic Events|hypoglycemic events|up to 5 days|||participants|||Number
160722|NCT00282867|Secondary|Favorable 3 Month Modified Rankin|3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.|3 months|||percentage of participants|||Number
160723|NCT00282828|Secondary|Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). We analyzed the overall change in LSAS (last Phase II LSAS minus Week 10 LSAS). Higher numbers reflect greater drops in social anxiety disorder severity. Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Change from Week 10 to Week 22|This analysis was conducted in Phase I non-responders, randomized to receive 12 weeks of continued sertraline plus the addition of clonazepam, switch to venlafaxine, or prolonged sertraline plus placebo.||units on a scale||Standard Deviation|Mean
160724|NCT00282828|Primary|Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders|The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.|Measured at Week 22 (Endpoint)|The present analysis was conducted in the modified ITT population (n=181), with remission based on week 22 LSAS for study completers (n=154, and last Phase II LSAS for the 27 patients who terminated early.||participants|||Number
160725|NCT00282815|Secondary|Barthel Index|Barthel Index score range: 0 (worst, fully dependent) - 100 (best, independent).|3 months|||units on a scale (range 0-100)||Inter-Quartile Range|Median
160726|NCT00282815|Primary|Number of Subjects Who Withdraw From Study.|Prespecified outcome.|3 months|||participants|||Number
160727|NCT00282815|Primary|Cumulative Continuous Positive Airway Pressure (CPAP)/Sham CPAP Usage Hours Over the 3 Month Period.||3 months|Data not available on one sham participant (lowering n from 11 to 10 in the shame group).||Hours/participant||Inter-Quartile Range|Median
160739|NCT00281658|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization to death (up to maximum of Month 53)|Intent-to-Treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
160728|NCT00281697|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to documented disease progression or death from any cause, whichever occurred first. Duration of objective response was only analyzed in patients who achieved an objective response.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline and achieved an objective response were included in the analysis.||Months||95% Confidence Interval|Median
160729|NCT00281697|Secondary|Objective Response|A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients who had measurable disease at baseline were included in the analysis.||Percentage of patients||95% Confidence Interval|Number
160730|NCT00281697|Secondary|One-year Survival|Percentage of patients who survived 1 year in the study.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Percentage of patients||95% Confidence Interval|Number
160731|NCT00281697|Secondary|Overall Survival|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the end of the study (up to 6 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
160732|NCT00281697|Secondary|Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)|Progression-free survival was defined as the time from randomization to first documented disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. Results are reported for each of the 4 standard chemotherapy cohorts used in the study.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
160733|NCT00281697|Primary|Progression-free Survival|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
160734|NCT00281658|Secondary|Number of Participants With a CR or PR at Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|The original outcome measure to be analyzed was time to response; however, data are presented as the number of participants with a response at each nominal visit. Responses are based on the investigator’s assessment, and only participants with a confirmed CR or PR were included in this analysis.|Weeks 8, 12, 16, 24, 32, 40, 48, 56, 64, and 72|Participants in the ITT Population with a confirmed CR or PR||participants|||Number
160735|NCT00281658|Secondary|Duration of Response|Duration of response is defined for the subset of participants with a confirmed CR or PR as the time from first documented evidence of CR or PR until the first documented sign of disease progression (radiological or clinical assessment of symptomatic progression) or death due to any cause during the randomized phase. Only participants with a confirmed CR or PR were included in this analysis. Disease progression is based on the assessments by the investigator.|Randomization to disease progression or death (up to a maximum of Month 53)|Participants in the ITT Population with a confirmed CR or PR||months||95% Confidence Interval|Median
160736|NCT00281658|Secondary|Clinical Benefit|Clinical benefit is defined as the number of participants achieving either a confirmed CR or PR or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions], taking as reference the smallest sum LD since treatment start) of >=24 weeks, based on confirmed responses from the investigator assessment of best overall response during the randomized phase.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population||participants|||Number
160737|NCT00281658|Secondary|Overall Response (OR)|OR, evaluated per Response Evaluation Criteria in Solid Tumors (RECIST), is defined as the number of participants achieving either a confirmed complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) of tumor, which were based on confirmed responses from the investigator assessment of best OR during the randomized phase. Participants with unknown or missing responses were treated as non-responders.|Randomization to disease progression or death (up to a maximum of Month 53)|ITT Population||participants|||Number
160874|NCT00282243|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
160740|NCT00281632|Secondary|Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
160741|NCT00281632|Secondary|Mean Change From Baseline to Response in Hemoglobin and Hematocrit|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided hematology measurements at both baseline and the time of response.||g/L||Standard Deviation|Mean
160742|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroid Stimulating Hormone|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||milliunits per liter (MU/L)||Standard Deviation|Mean
160743|NCT00281632|Secondary|Mean Change From Baseline to Response in Thyroxine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||nanomoles per liter (nmol/l)||Standard Deviation|Mean
160744|NCT00281632|Secondary|Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||millimoles per liter (mmol/l)||Standard Deviation|Mean
160745|NCT00281632|Secondary|Mean Change From Baseline to Response in Total Bilirubin and Creatinine|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||micromoles per liter (umol/l)||Standard Deviation|Mean
160746|NCT00281632|Secondary|Mean Change From Baseline to Response in Amylase and Lipase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||Units per liter (U/L)||Standard Deviation|Mean
160747|NCT00281632|Secondary|Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||International Units per liter (IU/L)||Standard Deviation|Mean
160748|NCT00281632|Secondary|Mean Change From Baseline to Response in Albumin|Change from baseline is calculated as the value at the time of response minus the value at Baseline.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided chemistry measurements at both baseline and the time of response.||grams per liter (g/L)||Standard Deviation|Mean
160749|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate|Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.|Baseline to response (up to 3 years)|All participants||participants|||Number
160750|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure|Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.||participants|||Number
160751|NCT00281632|Secondary|Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure|Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.|Baseline to response (up to 3 years)|All participants. Data are presented for only those participants who provided measurements at baseline and maximum shift post-baseline.||participants|||Number
160752|NCT00281632|Secondary|Overall Tumor Response|Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.|Baseline to response (up to 3 years)|All participants||participants|||Number
160753|NCT00281632|Secondary|Median Progression-free Survival (PFS)|Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes.|Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)|All participants with PFS||days||95% Confidence Interval|Median
160754|NCT00281632|Secondary|Overall Response and Stable Disease (SD)|Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.|Baseline to response (up to 3 years)|All participants||percentage of participants|||Number
160755|NCT00281632|Secondary|CA-125 Doubling Time Prior to and During Treatment With Pazopanib|CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.|Baseline to doubling of CA-125 (up to 3 years)|All participants with confirmed CA-125 50% reduction||hours||Standard Deviation|Mean
160891|NCT00282087|Secondary|Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)|Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)|2 years|||participants|||Number
160756|NCT00281632|Secondary|Duration of Biochemical Response (CA-125)|Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction||days||95% Confidence Interval|Median
160757|NCT00281632|Secondary|Time to Biochemical Response (CA-125)|Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.|Baseline to response (up to 3 years)|All participants with confirmed CA-125 50% reduction||days||Full Range|Median
160758|NCT00281632|Primary|Best Biochemical Response (Cancer Antigen [CA-125])|Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir >21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.|Baseline to response (up to 3 years)|All participants||percentage of participants|||Number
160759|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of dysplasia was calculated and all were free of dysplasia|5 years|||percentage of participants|||Number
160760|NCT00282672|Secondary|5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years.||5 years|||percentage of participants|||Number
160761|NCT00282672|Secondary|5 Year Extension: Serious Adverse Event Incidence||5 years|||participants|||Number
160762|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year||4 years|||percentage of participants|||Number
160763|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year||3 years|||percentage of participants|||Number
160764|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year||4 years|||percentage of participants|||Number
160765|NCT00282672|Secondary|5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year||5 years|||percentage of participants|||Number
160766|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year||5 years|||percentage of participants|||Number
160767|NCT00282672|Secondary|5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit||5 years|Similar analysis was performed and the result is provided for the outcome measure #14. The data were collected to answer the outcome measure #14.|||||
160768|NCT00282672|Secondary|For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years)||5 years|41 LGD patients and 21 HGD subjects completed the 5 year study and used for analysis.||percentage of participants|||Number
160769|NCT00282672|Secondary|Adverse Event Incidence|Data reported in the adverse event section|12 months for Treatment and Sham Comparison||||||
160770|NCT00282672|Secondary|Quality of Life Questionnaire (Baseline v. 12 and 24 Mos)||0, 12, and 24 months|Data had not been collected consistently to analyze the data.|||||
160771|NCT00282672|Secondary|Subject Discomfort : Chest Pain Score on Day 1|Chest pain score was measured on a visual analogue scale of 0 to 100, with higher scores indicating a greater severity of pain|Day 1 , if ablated|||Scores on a scale||Inter-Quartile Range|Median
160772|NCT00282672|Primary|Durability of Eradication With no Additional Treatments||5 year|41 LGD subjects and 32 HGD subjects completed 5 year visit||percentage of participants|||Number
160773|NCT00282672|Secondary|Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma)||5 year|||participants|||Number
160774|NCT00282672|Secondary|Histological Clearance of IM (% Biopsies)|% of patients with histological clearance of IM out of the number of participants analyzed at 12 month was calculated.|12 months|||percentage of participants|||Number
160775|NCT00282672|Secondary|Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups.||12 Month|16 HGD Sham procedure subjects crossed over to RFA treatment after one year||percentage of participants|||Number
160776|NCT00282672|Secondary|The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup||12 months|||percentage of participants|||Number
160777|NCT00282672|Primary|5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years|For patient who made it to the 5 year visit, % of patients demonstrating complete eradication of intestinal metaplasia (CE-IM) was calculated.|5 years|patient who made it to the 5 year visit||percentage of participants|||Number
160778|NCT00282672|Primary|The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months.|% of patients with complete eradication of IM out of the number of participants analyzed at 24 month was calculated.|24 Month|||percentage of participants|||Number
160779|NCT00282672|Primary|The % of Patients With Complete Eradication of Dysplasia at 12 Month|% of patients with complete eradication of Dysplasia out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-D at one year.||percentage of participants|||Number
160780|NCT00282672|Primary|The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month|% of patients with complete eradication of IM out of the number of participants analyzed at 12 month was calculated.|12 month|LGD: Radiofrequency group- 2 patients withdrew and were not analyzed, HGD: Radiofrequency Ablation: 4 patients withdrew and were not analyzed. LGD Sham procedure first then LGD Radiofrequency Ablation group and HGD Sham procedure first then HGD Radiofrequency Ablation group were not analyzed to measure the CR-IM at one year.||percentage of participants|||Number
160781|NCT00282568|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event was defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the day of last dose plus 10 days (approximately 60 months).|Modified safety analysis set||participants|||Number
160782|NCT00282568|Secondary|Number of Participants Returning to Permanent Dialysis|Permanent dialysis defined as dialysis for longer than 30 days.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
160783|NCT00282568|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis) or death. GBM = glomerular basement membrane.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||participants|||Number
160784|NCT00282568|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
160785|NCT00282568|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
160786|NCT00282568|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
160787|NCT00282568|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
160788|NCT00282568|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
160789|NCT00282568|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|"Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported."|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||participants|||Number
160790|NCT00282568|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection, the median number of days from enrollment to the date of biopsy confirmation. Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||days||Full Range|Median
160791|NCT00282568|Secondary|Time to Event for Graft Non Survival|For participants with graft loss, the median number of days from enrollment to graft loss. Graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||days||Full Range|Median
160792|NCT00282568|Secondary|Time to Event for Patient Non Survival|For participants who died on study, the median number of days from enrollment to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.||days||Full Range|Median
160793|NCT00282568|Secondary|Change From Baseline in Creatinine Clearance|Renal function was assessed using creatinine clearance levels calculated using the Cockcroft-Gault formula, over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set||mL/minute||Standard Deviation|Mean
160794|NCT00282568|Secondary|Change From Baseline in Serum Creatinine|Renal function was assessed using serum creatinine levels over the course of the study.|Baseline (the last day of tacrolimus on Day 7), Day 35 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. “N” indicates the number of participants with available data at each time point.”||mg/dL||Standard Deviation|Mean
160795|NCT00282568|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant or permanent return to dialysis (for more than 30 days)) or participants death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.||percentage of participants||95% Confidence Interval|Number
160796|NCT00282568|Primary|Patient Survival|Patient Survival defined as any participant who did not die by the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extension portion of the study.||percentage of participants||95% Confidence Interval|Number
160797|NCT00282568|Primary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|The time to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.||hours||Standard Deviation|Mean
160798|NCT00282568|Primary|Minimum Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 24-hour time point post- dose, prior to receiving the next dose.|Days 1 and 7 (tacrolimus) and Days 14 and 21 (tacrolimus MR), 24 hours post-dose.|The number of participants analyzed represents the trough evaluable set defined as all patients with replicate trough measurements for both tacrolimus and tacrolimus MR.||ng/mL||Standard Deviation|Mean
160799|NCT00282568|Primary|Maximum Observed Concentration (Cmax) of Tacrolimus|The maximum concentration was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set.||ng/mL||Standard Deviation|Mean
160800|NCT00282568|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute allograft rejection that was confirmed by biopsy results and was Banff grade ≥ IA. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||percentage of participants||95% Confidence Interval|Number
160801|NCT00282568|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the trapezoidal rule.|For tacrolimus, Days 1 and 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Days 14 and 21 pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The number of participants analyzed represents the Pharmacokinetic evaluable set, defined as patients with all five complete pharmacokinetic profiles (two tacrolimus and three tacrolimus MR).||ng*hr/mL||Standard Deviation|Mean
160802|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint|Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.|Baseline to Week 6 (endpoint)|Endpoint is Intent to Treat (ITT) Last Observation Carried Forward (LOCF). n = 140, 162; N = 180, 190||score on scale||Standard Error|Least Squares Mean
160803|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer|Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.|Baseline to week 6 (endpoint)|Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 137, 158; N = 180, 190||score on scale||Standard Error|Least Squares Mean
160804|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating|Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 97, 104; N = 180, 190||score on scale||Standard Error|Least Squares Mean
160805|NCT00282464|Secondary|Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject|Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 141, 164; N = 180, 190||score on scale||Standard Error|Least Squares Mean
160892|NCT00282087|Secondary|Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable||participants|||Number
160806|NCT00282464|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.|Baseline to week 6 (endpoint)|Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 149, 162; N = 180, 190||score on scale||Standard Error|Least Squares Mean
160807|NCT00282464|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score|Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.|Baseline to week 6 (endpoint)|Change from baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 153, 168; N = 180, 190||score on scale||Standard Error|Least Squares Mean
160808|NCT00282464|Secondary|Change in Global Assessment of Functioning (GAF)|Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.|Baseline to week 6 (Endpoint)|Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 154, 169; N = 180, 190||score on scale||Standard Error|Least Squares Mean
160809|NCT00282464|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range:0=not assessed, 1=very much improved, 7=very much worse|Baseline to Week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."||score on scale||Standard Error|Least Squares Mean
160810|NCT00282464|Secondary|Change in Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."||score on scale||Standard Error|Least Squares Mean
160811|NCT00282464|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. Overall is average response Week 1 - 6.|Baseline to week 6|"Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 – 6."||score on scale||Standard Error|Least Squares Mean
160812|NCT00282464|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
160813|NCT00282464|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"||score on scale||Standard Error|Least Squares Mean
160814|NCT00282464|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
160815|NCT00282464|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
160816|NCT00282464|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
160817|NCT00282464|Secondary|Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)|Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
160818|NCT00282464|Secondary|Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF|Baseline to Weeks 3, 6|"Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases.~Endpoint is ITT population Last Observation Carried Forward (LOCF)."||score on scale||Standard Error|Least Squares Mean
160819|NCT00282464|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Overall is Average of Weeks 1 - 6."||score on scale||Standard Error|Least Squares Mean
160820|NCT00282464|Secondary|Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7|Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"||Participants|||Number
160821|NCT00282464|Secondary|Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12|Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.|Week 1 to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"||Participants|||Number
160822|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.|Baseline to Week 3, Week 6|"Weeks 3, 6 are Intent to treat (ITT) population Observed Cases.~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"||Participants|||Number
160823|NCT00282464|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score|Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)|Baseline to Week 6|"Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases~Not all subjects responded at each week.~Endpoint is ITT population Last Observation Carried Forward (LOCF)"||participants|||Number
160824|NCT00282347|Secondary|Change From Baseline in C3 and C4 Complement Levels at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||mg/dL||Standard Deviation|Mean
160825|NCT00282347|Secondary|Change From Baseline in Anti-double-stranded DNA at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||IU/mL||Standard Deviation|Mean
160826|NCT00282347|Secondary|Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52|The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Units on a scale||Standard Deviation|Mean
160827|NCT00282347|Secondary|Time to Achieve a Complete Renal Response||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Weeks||95% Confidence Interval|Median
160828|NCT00282347|Secondary|British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks|The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Units on a scale||Standard Deviation|Mean
160829|NCT00282347|Secondary|Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo). Only those participants with a Baseline urine protein to creatinine ratio of > 3.0 were included in the analysis.||Percentage of participants|||Number
160830|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Percentage of participants|||Number
160831|NCT00282347|Secondary|Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52|A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5.|Week 24 to Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Percentage of participants|||Number
160893|NCT00282087|Secondary|Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)||2 years|Only 38 of the 47 patients were evaluable||participants|||Number
160832|NCT00282347|Primary|Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52|A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR.|Week 52|Intent-to-treat population: All randomized participants who received any amount of study drug (rituximab or placebo).||Percentage of participants|||Number
160833|NCT00282334|Primary|Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months|Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups|baseline and 6 months|Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.||mm Hg||Standard Deviation|Mean
160834|NCT00282334|Primary|Difference in Number of Patients Who Reached Target Blood Pressure||6 months||||||
160835|NCT00282308|Secondary|Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.|Week 24|Safety population: All patients who received any amount of rituximab or any vaccine. Since only limited efficacy data were collected in this study, the parameters necessary to calculate the ACR20/50/70 responses were only available for patients in Group A.||Percentage of patients|||Number
160836|NCT00282308|Secondary|Percentage of Patients Who Maintained a Positive Response to the C. Albicans Skin Test From Day 1 to Week 24 for Group A or From Day 1 to Week 12 for Group B|Patients received an intradermal injection of C. albicans on the volar surface of the forearm on Day 1 and Week 24 for Group A or on Day 1 and Week 12 for Group B. Forty-eight to 72 hours after injection, patients were evaluated for a delayed-type hypersensitivity response by measuring the diameter of induration (palpable raised, hardened area of the forearm skin). A positive response to the C. albicans skin test was defined as at least 5 mm in diameter of induration.|Day 1 to Week 24 for Group A and Day 1 to Week 12 for Group B|Skin test per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion, had Day 1 and Week 24 skin tests, and who provided complete diameter of induration readings. Group B – All patients randomized to Group B who had Day 1 and Week 12 skin tests and who provided complete diameter of induration readings.||Percentage of patients|||Number
160837|NCT00282308|Secondary|Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin|Anti-keyhole limpet hemocyanin antibody was measured immediately prior to and 4 weeks after the first administration of keyhole limpet hemocyanin. The keyhole limpet hemocyanin antibody ELISA assay used keyhole limpet hemocyanin as the plate coat and anti-human IgG-horseradish peroxidase for detection.|Week 32 to Week 36 for Group A and Week 8 to Week 12 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||IU/mL||95% Confidence Interval|Geometric Mean
160838|NCT00282308|Secondary|Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine|Anti-pneumococcal antibody was measured immediately prior to and 4 weeks after administration of a 23-valent pneumococcal polysaccharide vaccine. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||µg/mL||95% Confidence Interval|Geometric Mean
160839|NCT00282308|Secondary|Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine|Anti-tetanus antibody was measured in serum samples immediately prior to and 4 weeks after administration of a tetanus toxoid adsorbed booster vaccine. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||IU/mL||95% Confidence Interval|Geometric Mean
160875|NCT00282243|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
160840|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
160841|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to at Least 50% (≥ 6 of 12) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
160842|NCT00282308|Secondary|Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine|The immune response to each of the 12 anti-pneumococcal antibody serotypes was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The pneumococcal antibody assay was a fluoroimmunoassay that used a Luminex Multiplex platform. Purified capsular polysaccharides isolated from 12 serotypes of S. pneumonia were covalently attached to microbeads and used as a capturing reagent. Phycoerythrin conjugated anti-human IgG was used for detection. A positive immune response against a serotype was defined as a 2-fold increase or an increase of > 1 μg/mL from pre-vaccination levels.|Week 28 to Week 32 for Group A and Week 4 to Week 8 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
160843|NCT00282308|Secondary|Percentage of Patients With a 2-fold Increase in Tetanus Antibody Titers or With Tetanus Antibody Titers ≥ 0.2 IU/mL in Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
160844|NCT00282308|Primary|Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine|The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus antibody titers ≥ 0.1 IU/mL, a positive immune response to the booster immunization was defined as a 4-fold increase in antibody titer.|Week 24 to Week 28 for Group A and Day 1 to Week 4 for Group B|Immune response per-protocol population: Group A – All patients randomized to Group A who received any rituximab infusion and any vaccine and had pre-vaccination and 4-week post-vaccination blood samples. Group B – All patients randomized to Group B who received any vaccine and had pre-vaccination and 4-week post-vaccination blood samples.||Percentage of patients|||Number
160845|NCT00282282|Secondary|Disease Response.|Disease response was assessed as 2 year progression-free survival. The median follow-up time was 1.84 years. The percentage of participants with who reached this timepoint with no disease progression are reported.|2 years|||percentage of participants||95% Confidence Interval|Number
160846|NCT00282282|Secondary|Percentage of Participants With ≥90 Percent Donor-derived Hematopoeisis Around 100 Days Post Transplantation|The percentage of participants with ≥90 percent donor-derived hematopoeisis was assessed around day +100 using peripheral blood chimerism.|100 days|||percentage of participants|||Number
160847|NCT00282282|Primary|Incidence of Grade II-IV Acute GVHD (aGVHD) Developing by Day 100 Following Non-myeloablative PBSC Transplantation Using Tacrolimus and Sirolimus.|All participants received tacrolimus and sirolimus in this one arm study. There were no participants considered unevaluable for this measure (deceased prior to day 100). The total number of people who developed grade II-IV aGVHD before day 100 are reported here.|100 days|Participants who lived more than 30 days posttransplant were considered evaluable. Incidence of grade II-IV aGVHD was adjusted for participants who had aGVHD off-treatment.||participants|||Number
160888|NCT00282113|Secondary|Stool Colonization With Bifidobacteria|Using standard culture techniques, we measured how many of the first 11 infants in each arm of the study grew bifidobacteria in their feces after four weeks of treatment.|4 weeks|||Participants|||Number
167340|NCT00166205|Secondary|Changes in Total Cholesterol|Changes in Total Cholesterol, at three-years post-operative minus baseline.|3 years|||Mg/dl||Standard Deviation|Mean
160848|NCT00282256|Secondary|Safety as Assessed by Clinical Signs and Symptoms, Laboratory Parameters and Diagnostic Tests|"An adverse event (AE) is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 54 months).|Modified safety analysis set defined as all participants who took at least 1 dose of both tacrolimus and tacrolimus MR formulation during the pharmacokinetic period of the study.||participants|||Number
160849|NCT00282256|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.||participants|||Number
160850|NCT00282256|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 54 months).||||||
160851|NCT00282256|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 54 months).||||||
160852|NCT00282256|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||participants|||Number
160853|NCT00282256|Secondary|Number of Participants With Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||participants|||Number
160854|NCT00282256|Secondary|Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection|Steroid-resistant rejection episodes were treated with anti-lymphocyte antibodies. If a participant had a histologically proven Banff Grade II or III rejection, they could be initiated on anti-lymphocyte antibody treatment per institutional practice.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||participants|||Number
160855|NCT00282256|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||participants|||Number
160856|NCT00282256|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||days||Full Range|Median
160857|NCT00282256|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set with graft loss.||days||Full Range|Median
160858|NCT00282256|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 54 months).|Participants in the modified full analysis set who died on study.||days||Full Range|Median
160859|NCT00282256|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte. necrosis|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||percentage of participants|||Number
167341|NCT00166205|Secondary|Changes in Low Density Lipoproteins (LDL)|Changes in Low Density Lipoproteins (LDL), at three-years post-operative minus baseline.|3 years|||Mg/dl||Standard Deviation|Mean
160860|NCT00282256|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to reach the first observed maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.||hours||Full Range|Median
160861|NCT00282256|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 54 months).|Modified full analysis set.||percentage of participants||95% Confidence Interval|Number
160862|NCT00282256|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the end of the study.|From enrollment until the end of study (up to 54 months).|The Modified Full Analysis Set included all patients who took at least 1 dose of tacrolimus MR formulation during the extended treatment period.||percentage of participants||95% Confidence Interval|Number
160863|NCT00282256|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Day 7 at 12 hours post-dose (tacrolimus) and Day 14 at 24 hours post-dose (tacrolimus MR).|Pharmacokinetic evaluable set.||ng/mL||Standard Deviation|Mean
160864|NCT00282256|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR at steady state, without interpolation.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set.||ng/mL||Standard Deviation|Mean
160865|NCT00282256|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 and AUC 12-24 for the morning and afternoon doses.|For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose.|The pharmacokinetic evaluable set was defined as all patients who completed both pharmacokinetic profiles: one for tacrolimus, and one for tacrolimus MR. A complete pharmacokinetic profile was considered to be a profile that was adequate to determine AUC0-24, Cmax, and Cmin.||ng*hr/mL||Standard Deviation|Mean
160866|NCT00282243|Secondary|Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs|"An adverse event is defined as any reaction, side effect or other untoward medical occurrence, regardless of the relationship to study drug which occurred during the conduct of a clinical study. Clinically significant adverse changes in clinical status, routine laboratory studies or physical examinations were considered adverse events.~A serious adverse event was any adverse event occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant disability or incapacity~Congenital abnormality or birth defect~Important medical event."|From the first dose of tacrolimus MR formulation through the last dose day plus 10 days (approximately 60 months).|Modified safety analysis set.||participants|||Number
160867|NCT00282243|Secondary|Change From Baseline in Total Bilirubin|Hepatic function was assessed by measuring total bilirubin over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set. N indicates the number of participants with available data at each time point."||mg/dL||Standard Deviation|Mean
160868|NCT00282243|Secondary|Change From Baseline in Aspartate Aminotransferase (AST)|Hepatic function was assessed by measuring aspartate aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|Modified safety analysis set. “N” indicates the number of participants with available data at each time point.||U/L||Standard Deviation|Mean
160869|NCT00282243|Secondary|Change From Baseline in Alanine Aminotransferase (ALT)|Hepatic function was assessed by measuring alanine aminotransferase levels over the course of the study.|Baseline (the last day of tacrolimus on Day 14 prior to the first conversion to tacrolimus MR), Day 56 (end of the pharmacokinetic phase) and end of treatment (EOT; the last observed value during treatment, maximum time on study was 60 months).|"Modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus and at least one dose of tacrolimus MR during the pharmacokinetic portion of the study. N indicates the number of participants with available data at each time point."||U/L||Standard Deviation|Mean
160870|NCT00282243|Secondary|Primary Reason for Graft Loss|The primary reason for graft loss was recorded by the Investigator. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||participants|||Number
160871|NCT00282243|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as discontinuation of study drug for any reason. Due to discontinuation of the study by the sponsor, treatment failure was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
160872|NCT00282243|Secondary|Number of Participants With Chronic Rejection|Due to the low number of participants with biopsy-confirmed acute rejection episodes, chronic rejection was not analyzed.|From enrollment until the end of study (up to 60 months).||||||
160873|NCT00282243|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||participants|||Number
160894|NCT00282087|Secondary|Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)|Mitotic rate is measured in mitoses per 10 high-power fields|2 years|||mitoses per 10 high-power fields||Full Range|Median
160876|NCT00282243|Secondary|Grade of Biopsy-confirmed Acute Rejection Episodes|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. For participants with more than one biopsy-confirmed acute rejection episode, the worst case grade is reported.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||participants|||Number
160877|NCT00282243|Secondary|Time to First Biopsy-confirmed Acute Rejection|For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with a biopsy-confirmed acute rejection.||days||Full Range|Median
160878|NCT00282243|Secondary|Time to Event for Graft Non-survival|For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set with graft loss.||days||Full Range|Median
160879|NCT00282243|Secondary|Time to Event for Patient Non-survival|For participants who died on study, the median number of days from first dose of study drug to death due to any cause.|From enrollment until the end of study (up to 60 months).|Participants in the modified full analysis set who died on study.||days||Full Range|Median
160880|NCT00282243|Secondary|Percentage of Participants With Biopsy-confirmed Acute Rejection|Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||percentage of participants||95% Confidence Interval|Number
160881|NCT00282243|Secondary|Time to Maximum Observed Concentration of Tacrolimus (Tmax)|Time to the first occurrence to reach the maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set||hours||Standard Deviation|Mean
160882|NCT00282243|Primary|Graft Survival|Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death.|From enrollment until the end of study (up to 60 months).|Modified full analysis set||percentage of participants||95% Confidence Interval|Number
160883|NCT00282243|Primary|Patient Survival|Patient survival was defined as any participant known to be alive at the time of analysis.|From enrollment until the end of study (up to 60 months).|Modified full analysis set, defined as all patients who took at least one dose of tacrolimus MR during the extended treatment period of the study.||percentage of participants||95% Confidence Interval|Number
160884|NCT00282243|Primary|Minimum Observed Concentration of Tacrolimus (Cmin)|The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose.|Days 14 and 42 at 12 hours post-dose (tacrolimus) and Days 28 and 56 at 24 hours post-dose (for tacrolimus MR).|Pharmacokinetic evaluable set||ng/mL||Standard Deviation|Mean
160885|NCT00282243|Secondary|Maximum Observed Concentration of Tacrolimus (Cmax)|The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state, without interpolation.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set||ng/mL||Standard Deviation|Mean
160886|NCT00282243|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus|The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR treatment periods at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 for the morning (0-12 hour) and afternoon (12-24 hour) doses.|Days 14 and 42 (tacrolimus) and Days 28 and 56 (tacrolimus MR), pre-dose 0.5, 1, 2, 3, 4, 6, 8, 12 (pre-dose for tacrolimus only), 12.5, 13, 14, 15, 16, 18, 20, and 24 hours post-dose.|Pharmacokinetic evaluable set defined as all patients with four complete pharmacokinetic profiles (two tacrolimus and 2 tacrolimus MR).||ng*hr/mL||Standard Deviation|Mean
160887|NCT00282113|Secondary|Stool Short Chain Butyric Acid Content||4 weeks|||nmoles per mg stool||Standard Deviation|Mean
160898|NCT00282087|Secondary|Tolerability/Toxicity of This Regimen|Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.|Every 28 days during dosing and then every 3 months thereafter until patient comes off study|||number of major toxicity events|||Number
160899|NCT00282087|Primary|Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS||Every 3 months up to two years|||percentage of participants||95% Confidence Interval|Number
160900|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Overall Survival (OS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. OS is time in weeks from the start of study treatment to date of death due to any cause. Relationship of OS versus AUCss was determined as median OS in participants with high AUCss [AUCss >= median AUCss] or low AUCss [AUCss < median AUCss].|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and OS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.||weeks||Full Range|Median
160901|NCT00282048|Other Pre-specified|Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)|AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. PFS is median time from first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Relationship of PFS versus AUCss was determined as median PFS in participants with high AUCss [AUCss greater than or equal to (>=) median AUCss] or low AUCss [AUCss less than (<) median AUCss].|Day 1 (Pre-dose), Day 29, and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both PK and PFS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.||weeks||Full Range|Median
160902|NCT00282048|Other Pre-specified|Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)|AUCss: pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods, computed as each participant’s average total daily dose (accounting for dose reductions and any recorded missed doses) divided by population estimated posthoc individual apparent clearance (CL/F), i.e., AUCss = Daily Dose/(CL/F), where F refers to the oral bioavailability, and CL refers to the systemic clearance. PR: responses with at least 30% decrease in sum of longest dimensions of target lesions using baseline (pre-treatment) sum of longest dimensions as reference. Logistic regression with general linear model was applied to data of PR using AUCss; PR was correlated with AUCss as fold increase in odds of PR with increase in AUCss. Fold increase was calculated as exponent of product of logistic regression slope coefficient and unit change of AUCss.|Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks|Participants for whom both Pharmacokinetic (PK) and PR data were available were included in analysis.||Ratio|||Number
160903|NCT00282048|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)–Kidney Symptom Index (FKSI) Score|FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.||Units on a Scale||95% Confidence Interval|Mean
160904|NCT00282048|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks||||||
160905|NCT00282048|Secondary|Functional Assessment of Cancer Therapy (FACT)–Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score|FKSI-DRS is a subset of FKSI which is a questionnaire for FACT –Kidney Symptom Index used to assess Quality of Life (QoL)/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.|Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.||Units on a Scale||95% Confidence Interval|Mean
160906|NCT00282048|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the first dose for the last participant|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.||Days||95% Confidence Interval|Median
160919|NCT00281918|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants who died.||Days||95% Confidence Interval|Median
161793|NCT00268762|Primary|Symptomatic and Radiographic Intracerebral Hemorrhage|"Significant intracerebral hemorrhage as defined by either:~Symptomatic intracerebral hemorrhage or~Parenchymal hematoma type 2."|Within 7 days of enrollment|||percentage of patients||95% Confidence Interval|Number
160907|NCT00282048|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
160908|NCT00282048|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks|ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.||Days||95% Confidence Interval|Median
160909|NCT00282048|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.||Percentage of Participants||95% Confidence Interval|Number
160910|NCT00281957|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Weekly during first cycle, every two weeks during the second cycle, and once a cycle further cycles (one cycle = 4 weeks).|Eligible patients who had received any hydroxyurea||Participants|||Number
160911|NCT00281957|Secondary|One-year Overall Survival||One year after registration|||Percent of population||95% Confidence Interval|Number
160912|NCT00281957|Primary|4-month Progression-free Survival|Progression was defined as one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesions, death due to disease without prior documentation of progression and without symptomatic deterioration.|4 months after registration|||Percent of population||95% Confidence Interval|Number
160913|NCT00281957|Primary|Response Rate (Complete and Partial)|Complete response corresponds to complete disappearance of all measurable and non-measurable lesions with no new lesions. Partial response corresponds to greater than or equal to 30ﬁ decrease of sum of longest diameter of all target measurable lesions with no new lesion and non unequivocal progression of non-measurable disease.|Every 8 weeks until progression|||Percent of participants||95% Confidence Interval|Number
160914|NCT00281918|Secondary|Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)|The time from randomization to the start of a new treatment.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, who started a new CLL treatment.||Days||95% Confidence Interval|Median
160915|NCT00281918|Secondary|Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.|Median observation time was approximately 66.4 months|Intent-to-treat population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
160916|NCT00281918|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response or partial response who experienced an event (disease progression or death due to any cause).||Days||95% Confidence Interval|Median
160917|NCT00281918|Secondary|Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, all randomized participants, with complete response who experienced a disease free survival event (disease relapse or death).||Days||95% Confidence Interval|Median
160918|NCT00281918|Secondary|Final Analysis: Time to Event-free Survival Event|Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death.||Days||95% Confidence Interval|Median
161051|NCT00280826|Secondary|Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT).|Better eye indicates the eye with better VA.|Baseline and 16 weeks|Analysis was per protocol||microns||Standard Deviation|Mean
160920|NCT00281918|Primary|Final Analysis: Time to Progression-free Survival Event|Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 66.4 months|Participants from the Intent-to-treat population, that included all randomized participants, with PFS events.||Days||95% Confidence Interval|Median
160921|NCT00281918|Secondary|Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).|CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days to an event|||Number
160922|NCT00281918|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days|||Number
160923|NCT00281918|Secondary|Event-free Survival (EFS)|Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.|Median observation time at time of analysis was approximately 21 months|The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days||Full Range|Median
160924|NCT00281918|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.|Median observation time at time of analysis was approximately 21 months|The Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.||Days||Full Range|Median
160925|NCT00281879|Primary|Number of Participants With Disease Free Survival (DFS).|"Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies.~Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer."|Duration of the study; Up to 2 years|||Participants|||Number
160926|NCT00281840|Secondary|Response Rate|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD|5 years|Patients with evaluable tumors at the end of the study||participants|||Number
160927|NCT00281840|Primary|Time to Progression|The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained.|5 yrs after treatment|Patients who received at least one treatment on study||Months||95% Confidence Interval|Mean
160928|NCT00281827|Secondary|Number of Patients Alive at 56 Months (End of Study)|Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).|Up to 56 months|Calculated from study entry date to date of death or censored at date of last contact.||Participants|||Number
160929|NCT00281827|Secondary|Number of Patients Alive at 2 Years (Survival)|Participants who were alive at 2 years from date of enrollment.|24 Months|Calculated from date of first date of enrollment to date of death.||Participants|||Number
160930|NCT00281827|Secondary|Number of Patients Alive at 1 Year (Survival)|Participants who were alive at one year from date of enrollment .|12 Months|Calculated from date of first date of enrollment.||Participants|||Number
160931|NCT00281827|Secondary|Number of Patients Disease-free at 2 Years|Calculated from date of enrollment to date of recurrence or death, whichever came first|2 Years|||Participants|||Number
160932|NCT00281827|Secondary|Number of Patients Disease-free at 1 Year|Calculated from date of enrollment to date of recurrence or death, whichever came first|1 year|Calculated from study entry date to date of recurrence or date of death, whichever came first.||Participants|||Number
160933|NCT00281827|Primary|Number of Patients Reporting Clinical Response|Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.|At end of 3 -21 day cycles of treatment|2 of 22 patients did not receive all 3 drugs for all 3 cycles - only 20 patients achieved this and are thereby included here in the evaluable population analysis.||Participants|||Number
160934|NCT00281580|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)|Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|8 weeks|Treated set||percentage of participants|||Number
171555|NCT00113425|Secondary|Change From Baseline in Pustule Acne Lesions at Week 16||Baseline and Week 16|||pustule acne lesions||95% Confidence Interval|Mean
160935|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough pulse rate measurements included all treated patients that had at least one in-clinic pulse rate measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||bpm||Standard Deviation|Mean
160936|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
160937|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for mod-sev patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
160938|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
160939|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
160940|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
160941|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies"|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
160942|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
160943|NCT00281580|Other Pre-specified|BP Control|Responders SBP<10 mmHg and DBP<90 mmHg) for mod-sev patients - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||percentage of participants|||Number
160944|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
160945|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||percentage of participants|||Number
160946|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
160947|NCT00281580|Other Pre-specified|Change From Baseline in Seated Trough Cuff DBP|Observed results for mod-sev patients - key combination therapies|Nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
160948|NCT00281580|Secondary|Change From Baseline in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
161052|NCT00280826|Secondary|Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT).|Worse eye indicates the eye with the worst visual acuity (VA).|Baseline and 16 weeks|Analysis was per protocol||microns||Standard Deviation|Mean
160949|NCT00281580|Secondary|Change From Baseline in Seated Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
160950|NCT00281580|Secondary|Change From Baseline in Seated Trough Pulse Rate|Observed results for all patients - key combination therapies|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff Pulse Rate measurements included all treated patients that had at least one Pulse Rate measurement following treatment with target therapy (FAS-TC)||bpm||Standard Deviation|Mean
160951|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as moderate or severe hypertension at baseline (FAS-TC-MS), excluding patients treated with placebo||mmHg||Standard Error|Least Squares Mean
160952|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
160953|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Deviation|Mean
160954|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Error|Least Squares Mean
160955|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Up to 8 weeks (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)||mmHg||Standard Deviation|Mean
160956|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Error|Least Squares Mean
160957|NCT00281580|Primary|Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).||mmHg||Standard Deviation|Mean
160958|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean SBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Deviation|Mean
160959|NCT00281580|Secondary|Orthostatic Change in Trough Cuff Mean DBP|Calculated as seated minus standing for all patients - key combination therapies|Week 8|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Deviation|Mean
160960|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
160961|NCT00281580|Secondary|Change From Baseline in ABPM 24-hour Mean DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
160962|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
161083|NCT00280241|Secondary|Overall Survival Rate|The percentage of participants who are still alive.|Five years after starting rituximab, cyclophosphamide and fludarabine|||percentage of participants||95% Confidence Interval|Number
160963|NCT00281580|Secondary|Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP|Observed results - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.||mmHg||Standard Deviation|Mean
160964|NCT00281580|Secondary|BP Normality|"No: Mean seated SBP >=140 and/or mean seated DBP >=90 mmHg at trough High normal: mean seated SBP >=130 and <140 mmHg and mean seated DBP >=85 and <90 mmHg at trough Normal: mean seated SBP >=120 and <130 mmHg and mean seated DBP >=80 and <85 mmHg at trough Optimal: mean seated SBP < 120 mmHg and mean seated DBP <80 mmHg at trough~- key combination therapies"|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
160965|NCT00281580|Other Pre-specified|BP Control|Percentage of responders (SBP<140 mmHg and DBP<90 mmHg) for all patients - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy (FAS-TC).||percentage of participants|||Number
160966|NCT00281580|Secondary|SBP Response|SBP Response is defined as SBP < 140 mmHg or a reduction of SBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
160967|NCT00281580|Secondary|DBP Response|DBP response is defined as DBP < 90 mmHg or a reduction of DBP of >= 10 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
160968|NCT00281580|Secondary|DBP Control|DBP control is defined as DBP < 90 mmHg - key combination therapies|End-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||percentage of participants|||Number
160969|NCT00281580|Other Pre-specified|Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP|Observed results for key combination therapies|Baseline to nominal week over the trial|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
160970|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Error|Least Squares Mean
160971|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Error|Least Squares Mean
160972|NCT00281580|Secondary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)||mmHg||Standard Error|Least Squares Mean
160973|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC), excluding patients treated with placebo||mmHg||Standard Error|Least Squares Mean
160974|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Error|Least Squares Mean
160975|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)|Observed results|End-of-study visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
160976|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Error|Least Squares Mean
160977|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
160978|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)|Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.|Baseline to end-of-study (up to 8 weeks) visit (LOCF)|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Error|Least Squares Mean
160979|NCT00281580|Primary|Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)|Observed results|Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))|The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).||mmHg||Standard Deviation|Mean
160980|NCT00281528|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.|up to 56 months|Treated population||months||95% Confidence Interval|Median
160981|NCT00281528|Primary|The Number of Participants With a Dose Interruption of ABI-007|Number of participants who interrupted (omitted) a dose at some point in the treatment period. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population||Participants|||Number
160982|NCT00281528|Primary|The Number of Participants With at Least One Dose Delay for ABI-007|Participants with at least one dose delay for ABI-007. Treatment delays of no longer than 2 weeks allowed participants to recovery from acute toxicity. If treatment was delayed beyond 2 weeks, continuing treatment on protocol was at the physician’s discretion, based upon the best interests of the participant. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population||Participants|||Number
160983|NCT00281528|Primary|The Number of Participants With at Least One Dose Reduction for ABI-007|Participants with at least one dose reduction for ABI-007. ABI-007 (Abraxane) dose could be reduced according to protocol guidelines if the participant was experiencing toxicities. Participants were allowed two ABI-007 (Abraxane) dose reductions during the course of the trial. This outcome is considered to be both a safety and an efficacy outcome.|Up to 53 months|Treated population||Participants|||Number
160984|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Hemoglobin Levels as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) hemoglobin levels were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100g/L; Grade 2 = <100 - 80g/L; Grade 3 = <80 - 65g/L; Grade 4 = <65g/L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
160985|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Platelet Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) platelet counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
160986|NCT00281528|Primary|Participant Counts of the Most Severe Grade for White Blood Cells (WBC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) WBC counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal -3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
160987|NCT00281528|Secondary|Kaplan Meier Estimate for Participant Survival|Participant survival was summarized using Kaplan-Meier estimate of the time of first dose of study drug to the last known time that the participant was alive. Participants that were alive at the end of follow-up would be censored at the last known time that the patient was alive.|Up to 56 months|Treated population||Months||95% Confidence Interval|Median
160988|NCT00281528|Secondary|Kaplan Meier Estimate for Duration of Response|Duration of response was defined as the time from response to the time of disease progression for participants who achieve an objective confirmed complete (CR) or partial overall response (PR). Disease progression is based on the assessments by the investigator. Participants who did not have disease progression following a confirmed complete or partial target response were censored at the last known time that the participant was evaluated for response|Up to 43 months (until progressed)|Treated population who achieved a complete or partial response||Months||95% Confidence Interval|Median
160989|NCT00281528|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|Up to 43 months (until progressed)|Treated population||Months||95% Confidence Interval|Median
161084|NCT00280241|Primary|Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience any grade 3-5 toxicity.|Duration of treatment on study|||participants|||Number
160990|NCT00281528|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC) as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) ANC counts were graded using NCI CTCAE version 3:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9L; Grade 2 = <1.5 - 1.0*10^9L; Grade 3 = <1.0 - 0.5*10^9L; Grade 4 = <0.5*10^9L"|up to 54 months|Treated population who had at least one post baseline value||participants|||Number
160991|NCT00281528|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response (i.e., Total Response) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|"Using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), the percentage of participants achieving either~A complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or~A partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions or~Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for progressive disease."|Up to 43 months (until progressed)|Treated population||Percent of Total Participants|||Number
160992|NCT00281528|Primary|The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|Using the RECIST response criteria version 1.0, the percent of participants achieving either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Up to 43 months|Treated population||Percent of Total Participants|||Number
160993|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|PAPAW (.9 m/s, 10 W)||VO2 (ml/min)||Standard Deviation|Mean
160994|NCT00281463|Primary|Oxygen Consumption||in-lab visit when propelling on a computer controlled wheelchair dynamometer|personal w/c (.9 m/s, 10 W)||VO2 (ml/min)||Standard Deviation|Mean
160995|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12|dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng*h/mL/mg||Standard Deviation|Mean
160996|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12|AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng*h/mL||Standard Deviation|Mean
160997|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin|Cmin defined as pre-dose concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng/mL||Standard Deviation|Mean
160998|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax|dn-Cmax is defined as dose normalized peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng/mL/mg||Standard Deviation|Mean
160999|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax|Cmax defined as peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||ng/mL||Standard Deviation|Mean
161000|NCT00281320|Primary|Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax|Tmax defined as time to peak concentration.|Day 4 or 8|All-Subjects-Pharmacokinetically-Evaluable Group defined as all subjects for which at least one pharmacokinetic parameter could be calculated and who did not have any protocol violations interfering with pharmacokinetics.||hours||Full Range|Median
161001|NCT00281320|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).|up to 30 days after study medication stop date|Per protocol||participants|||Number
161002|NCT00281320|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).|Up to Day 42 (treatment period)|Per protocol||Participants|||Number
161003|NCT00281099|Secondary|ICD-indicated Patients With Class I Pacemaker Indication.|Number of subjects screened prior to enrollment that had Class I pacing indication at time of implant|Period of time prior to patient consent when considering patient for Implant/Enrollment|Centers kept a screening log, recording for each patient considered for new ICD implant and possible trial enrollment whether the patient had a Class I pacing indication at time of implant. The analysis consisted of descriptive statistics (counts of the 2051 screened patients).||participants|||Number
161004|NCT00281099|Secondary|All Cause Mortality|Death from any cause|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants who died|||Number
161085|NCT00279916|Secondary|Complete Normalization, Including Treatment Failures|Type A tympanogram and not taking antibiotics, oral decongestants, nasal spray or combo|6 weeks|||participants|||Number
161005|NCT00281099|Secondary|"Quality of Life (QOL) Score"|"Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life(QOL) Scores. For KCCQ, positive values mean improved QOL compared to baseline. For MLWHFQ, negative values mean improved QOL compared to baseline.~Scales: KCCQ 0-100 (0=worst, 100 best); MLWHFQ 0-105 (105=worst, 0=best)"|Baseline, 12, 24, and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Units on a scale||Standard Deviation|Mean
161006|NCT00281099|Secondary|Percent Ventricular Pacing|The percentage of a patients' ventricular beats that were paced by the device.|Enrollment, 6, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Percent pacing||Standard Deviation|Mean
161007|NCT00281099|Secondary|"Medication Usage Affecting Heart Rate and Atrioventricular (AV) Conduction"|Whether a subject is on each of a pre-specified set of drugs or classes of drugs.|Enrollment, 6 Months, 12 Months, 24 Months, 30 Months, 36 Months|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Percentage of Subjects|||Number
161008|NCT00281099|Secondary|Development of a Pacing Indication During the Study|Physician identification of a Class I Pacing Indication. A Class I Pacing Indication implies that the benefit of pacing the heart far exceeds the risk, and that the procedure to implant the pacing device should be performed. For this indication there is general agreement that pacing the heart is beneficial, useful, and effective.|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants|||Number
161009|NCT00281099|Secondary|Occurrence of Clinically Important or Persistent Atrial Tachycardia or Atrial Fibrillation (AT/AF) in Subjects With no Prior AF History|"Persistent AF was defined as any of the following:~2 consecutive visits in which the patient presents with AF~7 consecutive days of at least 22 hours per day of AT/AF~A cardioversion prior to 7 consecutive days of at least 22 hours per day of AT/AF~Clinically Important AF was defined as more than 20 hours of AT/AF in a single day"|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|1 of 1031 randomized subjects had a history of at least 6 months of chronic AF, which was an exclusion criterion. Of the remaining 1030 randomized subjects that met all inclusion criteria, only those with no history of AF were included in the analysis (445 in the VVI 40 arm and 444 in the MVP arm). An intention to treat analysis was performed.||participants|||Number
161010|NCT00281099|Secondary|"Occurrence of Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF) Episodes"|Annualized Rates of Days of True VT/VF and Inappropriately detected non-VT/VF|Enrollment to last collection of data from the implanted ICD (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Annualized Episodes per Patient Month|||Number
161011|NCT00281099|Secondary|Composite Mitral Regurgitation (MR) Severity Score|"Echocardiogram measures for this endpoint were obtained at multiple time points. Composite MR Severity was measured on a scale of None to Trivial to Grade IV, with Grade IV being the worst possible score and None to Trivial being the best possible score."|Baseline, 12, and 24 month visits|||participants|||Number
161012|NCT00281099|Secondary|Left Atrial (LA) and Mitral Regurgitation (MR) Areas|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||centimeters squared (cm2)||Standard Deviation|Mean
161013|NCT00281099|Secondary|Hemodynamic Deceleration Time|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||milliseconds (ms)||Standard Deviation|Mean
161014|NCT00281099|Secondary|Hemodynamic Velocity Measures|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||meters per second (m/s)||Standard Deviation|Mean
161015|NCT00281099|Secondary|Left Ventricular (LV) Sphericity Index|"Echocardiogram measures for each endpoint were obtained at multiple time points.~LV Sphericity Index is a ratio of LV long axis dimension to the LV short axis dimension. Healthy hearts have an elliptical LV cross-sectional shape. A value of 1 denotes a circular or more globular shape, while larger values denote healthier hearts with more elliptical cross sections. Literature has shown that when the ratio used is short axis/long axis, normal hearts have a median LV sphericity index of 0.56, with a range of (0.51-0.60). This translates to median=1.79,range=(1.67,1.96) for long/short axis."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||Ratio||Standard Deviation|Mean
161086|NCT00279916|Primary|Complete Normalization|Type A tympanogram in both ears|6 weeks|Number of participants based on those who completed the study ands who had a follow-up tympanogram||participants|||Number
171556|NCT00113425|Secondary|Change From Baseline in Papule Acne Lesions at Week 16||Baseline and Week 16|||papule acne lesions||95% Confidence Interval|Mean
161016|NCT00281099|Secondary|Left Ventricular (LV) and Left Atrial (LA) Volumes|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||milliliters (mL)||Standard Deviation|Mean
161017|NCT00281099|Secondary|Left Ventricular (LV) Ejection Fraction and Fractional Shortening|"Echocardiogram measures for each endpoint were obtained at multiple time points.~LV Ejection Fraction is the percentage of a patient's blood moved out of the left venricle when the heart pumps. The measure is recorded as a percentage(0-100%) and the normal range is 50-85%.~LV Fractional Shortening is the percent change in a patient's LV internal dimensions between systole (when the ventricles contract and expel blood) and diastole (when the ventricles expand and receive blood). The measure is recorded as a percentage(0-100%) and the normal range is 30-45%."|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||percentage of LV unit||Standard Deviation|Mean
161018|NCT00281099|Secondary|Heart Chamber Dimensions and Wall Thicknesses|Echocardiogram measures for each endpoint were obtained at multiple time points.|Baseline, 12, and 24 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||centimeters (cm)||Standard Deviation|Mean
161019|NCT00281099|Secondary|Distribution of Patients by NYHA (New York Heart Association) Functional Class Over Time|NYHA Classification at each scheduled Follow-up visit. The scale for this measure is as follows: NYHA I= best, NYHA IV= worst.|Baseline, 12, 24 and 36 month visits|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants|||Number
161020|NCT00281099|Secondary|Occurrence of Worsening Heart Failure-related Adverse Events|HF event meeting primary endpoint definition, or adverse events associated with, but not limited to, any of the following: symptoms or physical signs compatible with worsening HF, laboratory evidence of HF, any modification of oral heart failure therapy|Enrollment to last visit (up to 45 months post-randomization)|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||participants/events|||Number
161021|NCT00281099|Primary|"All Cause Mortality and Heart Failure-related Urgent Care Visits and Heart Failure (HF) Hospitalizations."|A composite endpoint of all cause mortality and HF hospitalizations or urgent care. (Emergency Department, Urgent Clinic visits, or hospitalizations wiht intravenous medications for HF)|Enrollment to last visit (up to 45 months post-randomization) or death|"1 of 1031 randomized subjects had a history of at least 6 months of chronic atrial fibrillation (AF), which was an exclusion criterion. The remaining 1030 randomized subjects met all inclusion criteria and made up the analysis cohort. An intention to treat analysis was performed for this objective."||events|||Number
161022|NCT00281021|Primary|Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen.||Measured every 6 weeks after baseline until disease progression, an average of 3 months|||participants|||Number
161023|NCT00280917|Secondary|Safety|Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs|12 weeks||||||
161024|NCT00280917|Secondary|ACR Criteria Components|ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness.|12 weeks||||||
161025|NCT00280917|Primary|ACR Efficacy Criteria|ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population|12 weeks|||participants|||Number
161026|NCT00280904|Primary|Number of Subjects With Shunt Infections|Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.|Implantation to Explant|||participants|||Number
161027|NCT00280904|Secondary|Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures||April 2008|||participants|||Number
161028|NCT00280059|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale|MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.|Week 8, Week 32, and Week 56|FAS||participants|||Number
161105|NCT00279214|Secondary|Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|Baseline, 96 hours|Number of per-protocol participants with values at baseline and 96 hours.||units on a scale||Standard Deviation|Mean
161029|NCT00280059|Secondary|Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)|Participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items; range: 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of symptoms. Scores relative to start of randomized treatment.|Baseline to Week 56|FAS; N = number of participants with a HADS measurement at baseline and Week 56.||scores on scale||Standard Error|Least Squares Mean
161030|NCT00280059|Secondary|Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group|Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.|Week 5 up to Week 56|FAS; N = number of participants with analyzable data.||percentage of participants|||Number
161031|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||28-day seizure rate||Standard Deviation|Mean
161032|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
161033|NCT00280059|Secondary|Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||28-day seizure rate||Standard Deviation|Mean
161034|NCT00280059|Secondary|Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.|Month 1 through Month 9 (after 6 months seizure freedom achieved)|FAS. N = number of responders; n = number of responders with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
161035|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Mean
161036|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Seizures|Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
161037|NCT00280059|Secondary|Mean Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Mean
161038|NCT00280059|Secondary|Median Monthy Seizure Frequency: All Partial Seizures|All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).|Baseline up to Week 60|FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.||seizures/28 days||Standard Deviation|Median
161039|NCT00280059|Secondary|Time to First Seizure After the 4-Week Dose Escalation Phase|Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.||days||95% Confidence Interval|Median
161107|NCT00279201|Secondary|ADDENDUM: HbA1c at Specified Visits and Endpoint||Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percent glycosylated hemoglobin||Standard Deviation|Mean
161040|NCT00280059|Secondary|Exit Due to Any Reason After 4-week Dose Escalation Phase|Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit for any reason after the 4-week dose escalation phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.||participants|||Number
161041|NCT00280059|Secondary|Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase|Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to lack of efficacy after 4-week dose escalation phase was inestimable as survival estimate at end of maintenance phase was below 0.500.||participants|||Number
161042|NCT00280059|Secondary|Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data Time to exit for any reason during the double-blind treatment phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.||participants|||Number
161043|NCT00280059|Secondary|Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)|Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.|Week 0 to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to adverse events was inestimable as survival estimate at end of maintenance phase was below 0.500.||participants|||Number
161044|NCT00280059|Secondary|Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures|Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.|Week 4 up to Week 56|FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.||days||95% Confidence Interval|Median
161045|NCT00280059|Primary|Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase|Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.|Week 5 up to Week 56|Full analysis set (FAS) (intent to treat population): randomized participants who took at least 1 dose of study medication. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data. Analysis excludes participants who did not enter maintenance phase of study.||percentage of participants|||Number
161046|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)|Number of participates with HF related pulmonary congestion event will be reported. Time to the first HF related pulmonary cogestion event in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups to see if there is significant difference. A HF related pulmonary congestion event is defined as hospitalization with signs and/or symptoms of pulmonary congestion, or outpatient treatment with IV diuretics due to exacerbation of HF with signs and/or symptoms of pulmonary congestion.|6 month to the 12 month visit|||participants|||Number
161047|NCT00279955|Secondary|Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)|Number of participates with HF realted healthcare utilization will be reported. Time to the first HF-related healthcare utilization in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related healthcare utilization between two groups. A heart failure related (HF-related) healthcare utilization is defined as unscheduled office visits, hospitalizations, urgent care visits, and emergency room visits which is resulted by heart failure related adverse event.|6 month to the 12 month visit|||participants|||Number
161048|NCT00279955|Primary|Occurrence of Heart Failure (HF) Related Adverse Event (AE)|Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the “Follow-up Period” from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject’s worsening HF or related to the heart’s inability to meet the metabolic demands of the body.|From 6 month to the 12 month visit|Of the 1001 subjects meeting inclusion and exclusion criteria, 643 subjects had been followed longer than 6 months and had the OptiVolTM feature save-to-disk data available. Those 643 subjects were included in this analysis.||participants|||Number
161049|NCT00280826|Secondary|Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks|||ETDRS letters||Standard Deviation|Mean
161050|NCT00280826|Secondary|Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|Baseline and 16 weeks|Analysis was per protocol||ETDRS letters||Standard Deviation|Mean
161053|NCT00280826|Primary|Number of Participants With Systemic Toxicities, Adverse Events, or Infections|Safety outcomes were recorded by observing and tabulating the nature, severity and frequency of systemic toxicities, adverse events and infections throughout the study. Safety assessments were made by the investigators continuously during the study, with a review of the previous visit interval performed at each scheduled visit. Each participant was also encouraged to report any apparent adverse events between scheduled visits and could return for additional evaluations or treatment between scheduled visits if needed.|16 weeks|Analysis was per protocol||Participants|||Number
161054|NCT00280683|Secondary|L-arginine Serum Concentration||90 days|||pmol/100ul||Standard Error|Mean
161055|NCT00280683|Primary|Number of Asthma Exacerbations in Three Months|Asthma exacerbation is a composite endpoint. An asthma exacerbation is defined as any of the following: a) a drop in the morning peak expiratory flow rate (PEF) >30% from baseline on 2 consecutive days, b) a need for initiation of or increased dose of inhaled corticosteroids, or the c) doubling of short-acting rescue β-agonist drug use (e.g.Albuterol) on two consecutive days. Any one of these three counts as one asthma exacerbation.|3 months|Our original power analysis was based on an expected minor exacerbation rate of 3-4 per month.||exacerbations|||Number
161056|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
161057|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
161058|NCT00280566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)|Period 2: Weeks 4 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
161059|NCT00280566|Secondary|Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
161060|NCT00280566|Secondary|Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period|Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.|Period 2: Weeks 1 - 24 or time of early termination|Intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
161061|NCT00280566|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period|Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.|Period 2: Weeks 1 - 24 or time of early termination|intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
161062|NCT00280566|Secondary|Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period|Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.|Period 2: Weeks 1 - 24 or time of early termination|Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.||scores on scale||Standard Deviation|Mean
161063|NCT00280566|Secondary|Modified Time to Intervention for a Mood Episode (TIME)|Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: Week 24 or time of early termination|Intent to Treat (ITT). 29 out of 127 ziprasidone subjects and 38 out of 111 placebo subjects met the modified criteria for an intervention for a mood episode||Days||Standard Error|Mean
161064|NCT00280566|Secondary|Time to Discontinuation for Any Reason During Double Blind Period 2|Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT). Number of participants who discontinued was 43 and 57 for ziprasidone and placebo, respectively.||days||Standard Error|Mean
161106|NCT00279214|Primary|Cumulative Vasopressor Index (CVI)|CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.|baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.||units on a scale||Standard Deviation|Mean
167342|NCT00166205|Secondary|Changes in High Density Lipoproteins (HDL)|Changes in High Density Lipoproteins (HDL), at three-years post-operative minus baseline.|3 year|||Mg/dl||Standard Deviation|Mean
161065|NCT00280566|Primary|Time to Intervention for a Mood Episode During Double Blind Period|Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.|Period 2: 24 weeks or time of early termination|Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode.||Days||Standard Error|Mean
161066|NCT00280397|Secondary|To Make Exploratory Analyses of Pharmacodynamic Markers||Every 3 weeks||||||
161067|NCT00280397|Secondary|Evaluate the Anti-tumor Activity of E7080||Every 3 weeks||||||
161068|NCT00280397|Secondary|Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile||Every 3 weeks||||||
161069|NCT00280397|Primary|DLT of E7080 Repeatedly Administered Twice a Day|DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.||Participants with DLT|||Number
161070|NCT00280397|Secondary|Number of Participants With Adverse Events / Serious Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.|All participants who received at least one E7080 dose and had evaluable data were included in the safety analyses.||Participants|||Number
161071|NCT00280397|Primary|Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day|The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.|up to 4 weeks|Registered participants were included in the tolerability analysis set with the exception of the ineligible participants, participants with a treatment compliance rate of less than 75%, and participants who discontinued the study for reasons other than occurrence of DLT. However, cases of DLT shall be included in analyses.||mg BID|||Number
161072|NCT00280397|Secondary|To Elucidate the Pharmacokinetic Profile of E7080||Every 3 weeks||||||
161073|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Area At Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline).|Baseline|||EDB M-Wave Area at Baseline (mVms)||Standard Deviation|Mean
161074|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Area Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave area induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave area (mVms) was measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave area reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave area reduction from baseline were presented as a percentage.|Baseline and Up to 12 Weeks|||Percentage of Reduction||Standard Deviation|Mean
161075|NCT00280384|Primary|Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude at Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline).|Baseline|||EDB M-Wave Amplitude at Baseline (mV)||Standard Deviation|Mean
161076|NCT00280384|Primary|Maximum Rates of Extensor Digitorum Brevis (EDB) Muscle M-Wave Amplitude Reduction From Baseline|The pharmacodynamic effect of botulinum toxin type B (E2014) was evaluated based on the inhibition of EDB M-wave amplitude induced by stimulation of the deep peroneal nerve in the left ankles of the study participants. EDB M-wave amplitudes (mV) were measured at screening (baseline), and Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 14, Week 4, and Week 12. Rates of EDB M-wave amplitude reduction from baseline were then calculated at each time point. The maximum rates of EDB M-wave amplitude reduction from baseline were presented as a percentage.|Baseline and Up to Week 12|||Percentage of Reduction||Standard Deviation|Mean
161077|NCT00280293|Primary|Positive Urine Drug Screens|Percentage of participants with a positive urine drug screen for cocaine at the week 10 visit or at last assessment if participant withdrew early.|10 weeks|||percentage of participants|||Number
161078|NCT00280293|Secondary|Dollars Spent|Dollars spent on cocaine during the 7 days of week 10, or at last assessment if participant withdrew early, based on self report.|10 weeks|||Dollars||Standard Deviation|Mean
161079|NCT00280293|Secondary|Depression Score on the Hamilton Rating Scale For Depression|Total score on the Hamilton Rating Scale for Depression at week 10 visit or at last assessment if participant withdrew early(total score values range 0 - 52. A higher score indicates more severe depression.|10 weeks|||units on a scale||Standard Deviation|Mean
161080|NCT00280293|Primary|Days of Cocaine Use|Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.|10 weeks|||days||Standard Deviation|Mean
161081|NCT00280241|Secondary|Duration of Response|The length of time for which the complete response is maintained.|From complete response to the time of progressive disease, death or last clinical examination|||Months||Full Range|Median
161082|NCT00280241|Primary|Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL|The number of patients who experience a complete clinical response.|Three months after the sixth cycle (9 months)|||participants|||Number
161087|NCT00279708|Secondary|Pulmonary Sarcoidosis Flares|Flare rates and relative risk: Flares (relapses) were defined as the physiological deterioration in pulmonary function due to worsened pulmonary inflammation. The criteria used for a pulmonary flare included: > 15% decline in static function (FEV1 post, FVC post); or (> 20% DLCO adj); or a > 15% decline in walk distance as measured by the six minute walk test, or via a decline in oxygen consumption collected during a cardiopulmonary exercise test (CPET). Additional factors considered included an increase in dyspnea (>15% increase in the dyspnea scale (TDI); and/or significant radiographic worsening. Clinical assessment of the patient’s status may have been factored into the criteria for flare determination as well.|1 year||09/2016||||
161088|NCT00279708|Primary|The Steroid Sparing Period|The duration of steroid sparing was defined as the date when the target dose of prednisone was reached until the date at which the dose was increased and/or met the relapse (flare) criteria; or until the 12 month study phase ended if no prednisone dose increase was required. The steroid sparing period was measured in units of days. The prednisone target dose was defined as a 90% reduction of the baseline dose or an absolute prednisone dose of 4 mg/day or less.|1 year|||days||Inter-Quartile Range|Mean
161089|NCT00279591|Secondary|Amount of Intravenous Fluid Resuscitation||At start of inter-facility transport, then every 15 minutes until arrival.|||ml/kg||Standard Deviation|Mean
161090|NCT00279591|Secondary|Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.|The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness.|Up to two weeks|This is the total number of participants analyzed for the intervention group and the control group and the total number of days analyzed overall for the intervention group and the control group.||units on a scale|Participants|Standard Deviation|Mean
161091|NCT00279591|Secondary|Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure.|Total number of organ failure days is for each group as a whole.|Up to two weeks|ITT||Days|Participants||Number
161092|NCT00279591|Secondary|Intensive Care Unit (ICU) Length of Stay||Up to two weeks|||days||Standard Deviation|Mean
161093|NCT00279591|Primary|The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care|This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall.|Up to two weeks|Intention to Treat||days||Standard Deviation|Mean
161094|NCT00279305|Primary|Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year|"The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.~The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."|When all participants complete the 1 year visit|||pmol per mL||95% Confidence Interval|Mean
161095|NCT00279214|Secondary|Mixed Venous Oxygen Saturation|Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.||percent saturation mixed venous oxygen||Standard Deviation|Mean
161096|NCT00279214|Other Pre-specified|Number of Participants With Bleeding Events|Serious bleeding event resulted in one of following outcomes, or was significant for any reason: initial/ prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly/birth defect. Intracranial hemorrhage was also considered serious bleeding event.|baseline to 7 days|All enrolled patients||participants|||Number
161097|NCT00279214|Secondary|Endogenous Protein C Level||Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.||percentage of Protein C activity||Standard Deviation|Mean
161098|NCT00279214|Secondary|7 Day All-cause In-hospital Mortality||baseline to 7 days|All enrolled patients||partipants|||Number
161099|NCT00279214|Secondary|Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours|CrCl = (urine creatinine*urine volume)/(plasma creatinine*time period of urine collection). Corrected CrCl = CrCl*1.73/body surface area. Change in CrCl = Endpoint minus baseline.|Baseline and 24 hours|Number of per-protocol participants with values at baseline and 24 hours.||milliliter per minute||Standard Deviation|Mean
161100|NCT00279214|Secondary|Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours|The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction).|Baseline and 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.||units on a scale||Standard Deviation|Mean
161101|NCT00279214|Secondary|Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)|Per vessel category (and per quadrant), scored flow as follows: no flow=0, intermediate flow=1, sluggish flow=2, continuous flow=3. The MFI per vessel category calculated with formula (Q1+Q2+Q3+Q4)/4. Scores could range from 0 (sluggish flow) to 3 (continuous flow).|Baseline to 24 Hours|Number of per-protocol participants with values at baseline, 12, and 24 hours.||units on a scale||Standard Deviation|Mean
161102|NCT00279214|Secondary|Lactate Level|Measures of global tissue perfusion and oxygenation were assessed via lactate levels.|Baseline to 6 Hours|Number of per-protocol participants with values at baseline and 6 hours.||millimoles per Liter||Standard Deviation|Mean
161103|NCT00279214|Secondary|Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index|Cardiac Index = cardiac output divided by body surface area.|Baseline to 24 Hours|Number of per-protocol participants with values at baseline and 24 hours.||liters/minute/meters squared||Standard Deviation|Mean
161104|NCT00279214|Secondary|Mean Arterial Pressure||baseline to 24 hours|Number of per-protocol participants with values at baseline and 24 hours.||mm Hg||Standard Deviation|Mean
161108|NCT00279201|Secondary|ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24||Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||ug/mL||Standard Deviation|Mean
161109|NCT00279201|Secondary|ADDENDUM: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||episodes/participant/year||Standard Deviation|Mean
161110|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percentage of participants|||Number
161111|NCT00279201|Secondary|ADDENDUM: Insulin Dose||Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||units/kg/day||Standard Deviation|Mean
161112|NCT00279201|Secondary|ADDENDUM: Body Weight||Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||kilograms||Standard Deviation|Mean
161113|NCT00279201|Secondary|ADDENDUM: Incremental Change From Baseline in Body Weight||Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||kilograms||Standard Deviation|Mean
161114|NCT00279201|Secondary|ADDENDUM: 7-point SMPG Profiles|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||mg/dL||Standard Deviation|Mean
161115|NCT00279201|Secondary|ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%||Endpoint (Addendum: 24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percent of participants|||Number
161116|NCT00279201|Secondary|ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint||Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.||percent||Standard Deviation|Mean
161117|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||mg/dL||Standard Deviation|Mean
161118|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose|Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||mg/dL||Standard Deviation|Mean
161119|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||ug/ml||Standard Deviation|Mean
161144|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG|Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
161120|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG|Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||ug/mL||Standard Deviation|Mean
161121|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
161122|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline|Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
161123|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
161124|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group|Comparison of baseline HbA1c group (<8.5,>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
161125|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
161126|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c|Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
161127|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
161128|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group|Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||participants|||Number
161129|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||years||Standard Deviation|Mean
161130|NCT00279201|Secondary|MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes|Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.|Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||years||Standard Deviation|Mean
161131|NCT00279201|Secondary|MAINTENANCE: Change From Baseline to Endpoint in HbA1c||Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
161132|NCT00279201|Secondary|MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol||Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||ug/dL||Standard Deviation|Mean
161133|NCT00279201|Secondary|MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||episodes/participant/year||Standard Deviation|Mean
161134|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percentage of participants|||Number
161135|NCT00279201|Secondary|MAINTENANCE: Insulin Dose||Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||units/kg/day||Standard Deviation|Mean
161136|NCT00279201|Secondary|MAINTENANCE: Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||kilograms||Standard Deviation|Mean
161137|NCT00279201|Secondary|MAINTENANCE: Incremental Change From Baseline in Body Weight||Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||kilograms||Standard Deviation|Mean
161138|NCT00279201|Secondary|MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%||Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percentage of participants|||Number
161139|NCT00279201|Secondary|MAINTENANCE: Rate of Increase in HbA1c|Rate of increase: HbA1c change/time period (month).|Endpoint (LOCF) (Maintenance: up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||HbA1c percent increase per month||Standard Deviation|Mean
161140|NCT00279201|Secondary|MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||mg/dL||Standard Deviation|Mean
161141|NCT00279201|Secondary|MAINTENANCE: HbA1c at Specified Visits and Endpoint||Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||percent glycosylated hemoglobin||Standard Deviation|Mean
161142|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline|Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||participants|||Number
161143|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose|Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
161145|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group|Comparison of baseline HbA1c percentage group (<8.5,>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||participants|||Number
161146|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c|Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
161147|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||units on a scale||Standard Deviation|Mean
161148|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin|Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||participants|||Number
161149|NCT00279201|Secondary|INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age|Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).|Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||years||Standard Deviation|Mean
161150|NCT00279201|Secondary|INITIATION: Insulin Dose||Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||units/kg/day||Standard Deviation|Mean
161151|NCT00279201|Secondary|INITIATION: Rate of Self-reported Hypoglycemic Episodes|Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||Episodes/participant/year||Standard Deviation|Mean
161152|NCT00279201|Secondary|INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes|Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.|Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percentage of participants|||Number
161153|NCT00279201|Secondary|INITIATION: Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||kilograms||Standard Deviation|Mean
161154|NCT00279201|Secondary|INITIATION: Incremental Change From Baseline in Body Weight||Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||kilograms (kg)||Standard Deviation|Mean
161155|NCT00279201|Secondary|INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)||Baseline (Initiation), Endpoint (Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
161156|NCT00279201|Secondary|INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions|Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.|Endpoint (LOCF) (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||milligrams per 100 Milliliters (mg/dL)||Standard Deviation|Mean
161157|NCT00279201|Secondary|INITIATION: HbA1c||Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
161158|NCT00279201|Secondary|INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percentage of participants|||Number
161159|NCT00279201|Secondary|INITIATION: Change in HbA1c From Baseline to 24 Weeks||Baseline (Initiation) to Endpoint (LOCF, Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
161160|NCT00279201|Primary|ADDENDUM: 24-Week Endpoint HbA1c|HbA1c at 24-week endpoint in Intensification Addendum of the trial.|Endpoint (Addendum) (24 weeks: Week 48)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: Week 24: 48 weeks.||percent glycosylated hemoglobin||Standard Deviation|Mean
161161|NCT00279201|Primary|MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)|HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%|Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)|Last observation carried forward method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.||months||95% Confidence Interval|Median
161162|NCT00279201|Primary|INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)||Endpoint (Initiation: Week 24)|Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment in the initiation phase. Initiation baseline: Week 0.||percent glycosylated hemoglobin||Standard Deviation|Mean
161163|NCT00278993|Secondary|Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|12 months|Per Protocol Population||Percentage of Participants|||Number
161164|NCT00278993|Secondary|Overall Survival||12 months|Intent to Treat Population||Days||Full Range|Median
161165|NCT00278993|Secondary|Progression Free Survival|From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.|12 months|Per Protocol Population||Days||Full Range|Median
161166|NCT00278993|Secondary|Duration of Prostate Specific Antigen Response Based on Bubley Criteria|Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir.|12 months.|Per Protocol Population||Days||Full Range|Median
161167|NCT00278993|Primary|Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from >50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.|12 months|Per Protocol Population||Percentage of Participants|||Number
161168|NCT00278954|Secondary|The Pharmacokinetic (PK) Mean Residence Time (MRT) for Inmuunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|||Days||Standard Deviation|Mean
161169|NCT00278954|Secondary|The Pharmacokinetic (PK) Volume of Distribution (Vz)of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.||dL/kg||Standard Deviation|Mean
161170|NCT00278954|Secondary|The Pharmacokinetic (PK) Clearance of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 min, 24, 48 hrs, 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.||mL/day/kg||Standard Deviation|Mean
161171|NCT00278954|Secondary|The Pharmacokinetic (PK) Half-Life of Immunoglobulin G (IgG)|Blood samples for PK analysis were obtained and analysed at 10 different time points, i.e. -5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days, at an infusion visit following 6 months of treatment.|-5, 0, 60 minutes (min), 24, 48 hours (hrs), 4, 7, 14, 21 and 28 days|Only 24 of the 45 evaluable subjects participated in the Pharmacokinetic part of the protocol. No data imputation.||Days||Standard Deviation|Mean
161172|NCT00278954|Primary|Number of Serious, Acute, Bacterial Infections (SABIs) Per Subject Per Year in Subjects With Primary Immunodeficiency Disease.|By assessing the number of serious, acute, bacterial infections per subject per year in subjects with Primary Immunodeficiency disease.|12 months|Intent to Treat (ITT).||SABIs/subject/year|||Number
161173|NCT00278915|Secondary|Percentage of Patients With Gsα Mutation.|McCune-Albright Syndrome(MAS) is caused by an activating mutation in the gene coding for the stimulatory subunit of the G protein, Gsα. The altered Gsα causes autonomous activation of G-protein stimulated cAMP formation, which in the gonads, results in episodic uncontrolled sex steroid production and subsequent pubertal development. For patients who provided separate specific informed consent, the percentage of patients with a Gsα mutation at screening was assessed by molecular analysis.|Screening assessment (baseline)|||Percentage of participants|||Number
161174|NCT00278915|Secondary|Change in Predicted Adult Height (PAH) From Baseline to Month 12.|Change in PAH from baseline to Month 12/final visit for patients equal to or over 6 years of age.|6 month pre-treatment observation period (result at Screening considered as baseline) followed by 12 month treatment period (on treatment period).|||cm||Standard Deviation|Mean
161175|NCT00278915|Secondary|Change in Pubic Tanner Stage From Baseline to Month 12.|Change in pubic Tanner stage from baseline to Month 12/last visit. Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).|||units on a scale||Full Range|Median
161176|NCT00278915|Secondary|Change in Breast Tanner Stage From Baseline to Month 12.|Change in breast Tanner stage from baseline to Month 12/last visit. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast|6 month pre-treatment observation period (result at Month 0 considered as baseline) followed by 12 month treatment period (on treatment period).|||units on a scale||Full Range|Median
161177|NCT00278915|Secondary|PK: Mean Volume of Distribution (V2/F) .|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V2/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.|||Litres||Standard Error|Mean
161178|NCT00278915|Secondary|PK: Mean Volume of Distribution (V1/F)|Total apparent volume of distribution (Vss/F) is the total apparent volume in the body into which Fulvestrant distributes at equilibrium. Vss/F = V1/F + V2/F. V1/F is the volume of the 1st compartment and V2/F is the volume of the second compartment. V1/F only is presented here. The measure of variability presented is the inter-individual error.|Throughout the 12 month treatment period.|||Litres||Standard Error|Mean
161179|NCT00278915|Secondary|PK: Mean Clearance.|Mean clearance is the average amount of Fulvestrant which is eliminated|Throughout the 12 month treatment period.|||Litres/hour||Standard Deviation|Mean
161180|NCT00278915|Secondary|Hormone Assays: Testosterone.|Hormone assays: testosterone at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.|||nmol/Litres||Standard Deviation|Mean
161181|NCT00278915|Secondary|Hormone Assays: Follicle-stimulating Hormone (FSH).|Hormone assays: follicle-stimulating hormone (FSH)at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period..|Month 12 of the treatment period.|||IU/Litres||Standard Deviation|Mean
161182|NCT00278915|Secondary|Hormone Assays: Luteinizing Hormone (LH).|Hormone assays: Luteinizing hormone (LH) at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.|||IU/Litres||Standard Deviation|Mean
161183|NCT00278915|Secondary|Hormone Assays: Serum Oestradiol.|Hormone assays: serum oestradiol at Screening visit (baseline), Month 12 of the treatment period. Results presented relate to Month 12 of the treatment period.|Month 12 of the treatment period.|||pmol/Litres||Standard Deviation|Mean
161184|NCT00278915|Secondary|Change in Ovarian Volume From Month 6 to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.|||cm^3||Full Range|Median
161185|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 6 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.|||cm^3||Full Range|Median
161186|NCT00278915|Secondary|Change in Ovarian Volume From Baseline to Month 12 by Ultrasound.||Screening visit (baseline), Months 6 and 12 during the treatment period.|||cm^3||Full Range|Median
161187|NCT00278915|Secondary|Change in Uterine Volume From Month 6 to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Month 6 and Month 12 during the treatment period.|||cm^3||Full Range|Median
161188|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 6 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 6 during the treatment period.|||cm^3||Full Range|Median
161189|NCT00278915|Secondary|Change in Uterine Volume From Baseline to Month 12 by Ultrasound.|Uterine volume was calculated via ultrasound using the formula: 0.5(longitudinal multiplied by anteroposterior multiplied by transverse), if all 3 linear dimensions were recorded. If all 3 linear dimensions were not recorded, uterine volume was not calculated.|Screening visit (baseline) and Month 12 during the treatment period.|||cm^3||Full Range|Median
161190|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Whole 12 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the full 12 month treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||Z-Score||Standard Deviation|Mean
161191|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the Second 6 Month Trial Period.|Change in growth velocity (Z-Score) from pre-treatment to the second 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||Z-score||Standard Deviation|Mean
161192|NCT00278915|Secondary|Change in Growth Velocity (Z-Score) Over the First 6 Month Trial Period.|Change from pre-treatment period to the first 6 months of the treatment period. Z-score is [(growth velocity from the previous visit to the current visit – mean) / standard deviation(SD)], where the mean and SD are from the National Center for Health Statistics, Fels study.|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)|||Z-Score||Standard Deviation|Mean
161193|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Whole 12 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the full 12 month treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
161194|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Second 6 Month Trial Period.|Change in growth velocity (annualised growth velocity i.e. cm/y) from the pre treatment period to the second 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
161195|NCT00278915|Secondary|Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the First 6 Month Trial Period.|Change in growth velocity (annualised growth velocity.i.e. cm/y) from the pre treatment period to the first 6 months of the treatment period. Growth velocity for a particular time period was calculated as the increase in height over that time period divided by the length of that time period (expressed in cm/year)|6 month pre-treatment observation period (baseline) followed by 6 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
161196|NCT00278915|Secondary|Change in Bone Age Advancement Over the Whole 12 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the full 12 month treatment period. (Using last value carried forward method for the one patient who withdrew soon after their month 6 bone scan) Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||cm/year||Standard Deviation|Mean
161197|NCT00278915|Secondary|Change in Bone Age Advancement Over the Second 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the second 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to second 6 months of the treatment period.|||cm/year||Standard Deviation|Mean
161198|NCT00278915|Secondary|Change in Bone Age Advancement Over the First 6 Month Trial Period.|Change in the rate of increase in bone age from pre treatment (based on the 6 month retrospective visit) to the first 6 months of the treatment period. Bone age advancement for a particular time period was calculated as the increase in bone age over that time period adjusted (ie, normalized) for the length of that time period.|baseline to first 6 months of the treatment period|||cm/year||Standard Deviation|Mean
161199|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding .|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for the full 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||Percentage of Participants|||Number
161200|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6 Month Trial Period.|Percentage of participants with baseline vaginal bleeding who experienced cessation of vaginal bleeding for at least 180 consecutive days during the 12 month treatment period, based on a worst-case approach i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|This particular protocolled endpoint does not relate to all patients but only those who had baseline vaginal bleeding - N=23 rather than N=30.||Percentage of Participants|||Number
161201|NCT00278915|Secondary|Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥50% Reduction in the Number of Vaginal Bleeding Days|Percentage of participants with baseline vaginal bleeding who experienced ≥50% reduction in the number of vaginal bleeding days during the 12 month treatment period compared to the 6 month baseline period.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|Number of participants (23) = number of eligible participants who have had bleeding during the 6 month baseline period||Percentage of Participants|||Number
161202|NCT00278915|Primary|Change in the Frequency of Annualised Days of Vaginal Bleeding|Change in the frequency of annualised days of vaginal bleeding during the 12 month treatment period compared to the 6 month baseline period, based on a worst-case scenario calculation .i.e. missing diary card days counted as bleeding days.|6 month pre-treatment observation period (baseline) followed by 12 month treatment period (on treatment period)|||days per year||Full Range|Median
161203|NCT00278889|Secondary|QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
161204|NCT00278889|Secondary|QOL: Time to Worsening of Clear Cell Sarcoma (CCS)|Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
161205|NCT00278889|Secondary|QOL: Time to Worsening of Treatment-free Survival (TFS)|Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
161206|NCT00278889|Secondary|Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)|Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires|Randomisation to data cut-off date of November 2007|||Days||Inter-Quartile Range|Median
161207|NCT00278889|Secondary|Overall Survival|Number of months from randomisation to the date of death from any cause|Randomisation to data cut-off date of 30 January 2009|||Months||Inter-Quartile Range|Median
161208|NCT00278889|Secondary|Objective Response Rate|"Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST."|Randomisation to data cut-off date of November 2007|||Participants|||Number
161209|NCT00278889|Primary|Progression Free Survival|Number of months from randomisation to the earlier date of objective progression or death|Randomisation to data cut-off date of November 2007|||Months||Inter-Quartile Range|Median
161210|NCT00278876|Secondary|Toxicity Profile|Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib|Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 3 years.|||participants|||Number
161211|NCT00278876|Secondary|2-year Overall Survival Rate||2 years|||percentage of participants|||Number
161212|NCT00278876|Primary|2-year Relapse Free Survival Rate||2 years|||percentage of participants|||Number
161213|NCT00278863|Secondary|Number of Patients With Adverse Events|Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years|Up to 2 years|||participants|||Number
161214|NCT00278863|Primary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD~Response rate is defined as the proportion of patients who showed OR."|Up to 2 years|||percentage of participants||95% Confidence Interval|Number
161215|NCT00278655|Secondary|Survival|"Data are reporting the number of participants who survived three years after the transplant~Survival of 21 participants was evaluated at three years after the transplant"|three years|||participants|||Number
161216|NCT00278655|Primary|Disease Progression|Data are reporting number of participants with disease progression. Disease progression is defined as a 1 point increase in the Expanded Disability Status Scale (EDSS) on consecutive evaluations at least 3 months apart.|3 years after transplant|||participants|||Number
161217|NCT00278525|Primary|Disease Improvement|"Data are reporting number of participants that were classified as disease improvement.~Definition of disease improvement:~Disease improvement defined by at least 25% improvement in skin score (Rodnan), or 10% improvement in pulmonary function tests [diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA), or forced vital capacity (FVC)], or in cardiac tests [pulmonary artery (PA) systolic pressure by right heart cath] that persists > 6 months or ability to wean off total parenteral nutrition (TPN)"|12 months|||participants|||Number
161218|NCT00278525|Primary|Time to Treatment Failure|"-Data are reporting number of participants that were classified as treatment failures~Time to Treatment Failure Definition-Treatment failure will not occur until a minimum of 12 months after enrollment at which time failure is defined as:~Failure of skin score (if > 14 on enrollment) to improve or increase in skin score by a 25% above lowest post treatment value and must be documented on 2 occasion 6 months apart~Deterioration in diffusing capacity of the lung for carbon monoxide (DLCO), diffusing capacity divided by the alveolar volume (DLCO/VA) or forced vital capacity (FVC) by 10% below enrollment level or 10% below best post treatment value, due to systemic sclerosis, and documented on 2 occasion 6 months apart~Renal failure due to systemic sclerosis and defined as chronic dialysis for more than 12 months~Gastrointestinal failure due to systemic sclerosis and defined as initiation of total parenteral nutrition(TPN) for more than 12 months"|12 months|All participants were included||participants|||Number
161219|NCT00278395|Secondary|Safety and Tolerability||1 year||||||
161220|NCT00278395|Secondary|Overall Survival (OS) and Median OS||1 year||||||
161221|NCT00278395|Secondary|Progression-free Survival||1 year||||||
161222|NCT00278395|Primary|Objective Response|"Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria.~Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1 year|The overall duration of response will be estimated using the Kaplan-Meier method for all patients who presented with an objective response.||participants|||Number
161223|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Measurements|"ICD/CRT-D baseline programming measurements, detection interval. Implanted Cardioverter/Defibrillator paces a patient's heart in a tachyarrhythmia prevention-pacing mode.~Detection intervals are used to detect atrial tachyarrhythmia. Detection Intervals are programmable heart rate thresholds. R-R intervals that are less than the VT or VF detection intervals (in ms) are considered evidence of VT or VF, respectively. R-R intervals that are between the FVT and the VF detection intervals are considered evidence of FVT. Thus, these detection interval thresholds demarcate rate zones of detection. The rate zones are used to determine the type of therapy applied once detection occurs."|Baseline|||ms||Standard Deviation|Mean
161224|NCT00277524|Secondary|Frequencies of Subjects With OptiVol Trends and Disease Progression.|"Estimate the correlation between OptiVol trends and disease progression.~A subject’s disease status was said to have progressed if:~The NYHA classification number increases (example: I to II), or~The LVEF decreases by at least 20% (relative difference) and by at least a 5% absolute difference, or~The subject expires~A subject who crossed OptiVol threshold since last visit was regarded as 'crossed threshold'."|4 years post implant|||participants|||Number
161225|NCT00277524|Secondary|"Compare First Shock Rate Between Medtronic PainFREE Programming and SCD-HeFT Programming in Primary Prevention Study Participants."|"First shock rate for VF and FVT zones was estimated using Kaplan-Meier method.~OMNI “PainFREE” definition: programming combinations that result in ATP therapy for ventricular tachycardia (VT) at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.~OMNI “SCD-HeFT” definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms."|4 years post implant|||rate||Standard Deviation|Mean
161226|NCT00277524|Secondary|Summary of ATP Episodes Within All Treated Episodes|Evaluate the utility of the Antitachycardia Pacing (ATP) During Charging feature of the device.|4 years post enrollment|||Episodes|||Number
161227|NCT00277524|Secondary|AV Block Status by Severity of Historical AV Block|Frequencies of Subjects with AV Block Over Time by Severity of Historical AV Block|4 years post implant|||participants|||Number
161228|NCT00277524|Secondary|AV Block Status by Device Type at 6 and 12 Months.|Frequencies of subject with AV block over time between ICD and Implantable Pulse Generator(IPG) study participants.|12 months post enrollment|||participants|||Number
161268|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio|Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|||Percent Change||95% Confidence Interval|Least Squares Mean
161269|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)|Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
161229|NCT00277524|Primary|ICD/CRT-D Device Baseline Programming Frequencies|ICD/CRT-D baseline programming, pacing mode and detection. Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline|||participants|Participants||Number
161230|NCT00277524|Primary|Implantable Pulse Generator (IPG) Device Baseline Programming Frequencies.|Pacing mode is based on the NASPE/BPEG Generic (NBG) Pacemake coding which includes: I, the chambers paced (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); II, the chambers sensed (V= Ventricle, A=Atrium, D=Dual (A&V), O=None); III, the mode of response (T=Triggered, I=Inhibited, D=Dual Triggered/Inhibited, O=None); IV, the programmable functions(R=Rate Modulated, C=Communicating, M=Multiprogrammable, P=Simple Programmable, O=None); V, the antitachycardia functions (O=None, P=Paced, S=Shocks, D=Dual (P&S)). In addition, MVP (managed ventricular pacing) is a mode that promotes AV conduction by reducing or eliminating unnecessary RV pacing but maintains dual chamber ventricular support in the event that AV conduction is lost.|Baseline|||participants|||Number
161231|NCT00277524|Primary|Implanted Systems Frequencies|Frequencies of implanted systems were measured among patients who were implanted with a device (IPT, ICD or CRT-D).|Baseline|||participants|||Number
161232|NCT00277446|Secondary|Forced Expiratory Volume in One Second (FEV1)|Forced expiratory volume in one second (FEV1) measured as liters/second|0 and 4 weeks|||liters/sec||Standard Deviation|Mean
161233|NCT00277446|Secondary|Eosinophil LTC4 Synthesis|Peripheral blood eosinophils were isolated before and after treatment with Novasoy, stimulated with calcium ionophore, and the amount of leukotriene C4 (LTC4) produced was measured by EIA.|0 and 4 weeks|||ng/ml||Standard Deviation|Mean
161234|NCT00277446|Primary|Exhaled Nitric Oxide|Exhaled nitric oxide at baseline (week 0) and at 4 weeks|0 and 4 weeks|Per protocol||parts per billion (ppb)||Standard Deviation|Mean
161235|NCT00277394|Secondary|Number of Patients With Major Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses||Patients|||Number
161236|NCT00277394|Secondary|Number of Patients With Recurrence of Venous Thromboembolism||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses||Patients|||Number
161237|NCT00277394|Primary|Number of Patients With Clinically Relevant Bleeding Events||prior to day 90 +/- 5|2 patients randomised to the Heparin group withdrew their consent just after randomisation and before taking any study treatment. No data were collected after visit 1, and due to the nature of the withdrawal, no further information was possible to collect. These patients were excluded from all analyses||Patients|||Number
161238|NCT00277355|Secondary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [Regression Based Multiple Imputation Method]|TFC consists of five ordinally scaled items assessing a person’s capacity with: (1) occupation; (2) financial affairs; (3) domestic responsibilities; (4) activities of daily living; and (5) independent living. Total score ranges from zero (worst) to 13 (best). Regression based imputation was used to impute missing values.|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.||units on a scale||Standard Deviation|Mean
161239|NCT00277355|Primary|Change From Baseline to Month 18 in the Total Functional Capacity (TFC) Scale [LOCF Imputation Method]|Establish preliminary estimate of minocycline's impact on progression of HD (measured by the change in Total Functional Capacity (TFC) score of Unified Huntington's Disease Rating Scale [UHDRS] between baseline & Month 18), and to assess futility of further study of minocycline. TFC consists of five ordinally scaled items assessing a person's capacity with: 1. occupation 2. financial affairs 3. domestic responsibilities 4. activities of daily living and 5. independent living. Total score ranges from zero (worst) to 13 (best).|Baseline to 18 months|The primary analyses were performed according to the intent to treat principle and included all randomized subjects. Two strategies were used to address missing data: 1. Last observation carried forward (LOCF) was used to impute missing values and 2. A secondary method of regression-based multiple imputation was also used.||units on a scale||Standard Deviation|Mean
161240|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.||units on a scale||Standard Error|Mean
161270|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)|Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
161271|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Triglycerides (TG)|Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
167432|NCT00167206|Secondary|Number of Patients Alive at 1 Year|Calculated from Day 1 of hematopoietic cell transplant to 1 year post-transplant.|1 year after transplant|||Participants|||Number
161241|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.||units on a scale||Standard Error|Mean
161242|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement.|Baseline, Weeks 8, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit). n=number of participants analyzed at timepoint.||units on a scale||Standard Error|Mean
161243|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 2||Phase 2 (52 Week Double-blind Relapse Assessment Phase)|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).||participants|||Number
161244|NCT00277212|Secondary|Summary of Concomitant Medications, Phase 1||Phase 1 (9 to 24 Week Single-blind Stabilization Phase)|Phase 1 Safety Sample (all patients who take at least one dose of singleblind aripiprazole in Phase 1, as indicated on the study therapy form).||participants|||Number
161245|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)|Chemistry, hematology, and urinalysis abnormalities.Abbreviations used: alanine aminotransferase (ALT), institutional upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), baseline (BL)|Throughout Phase 2 of the study, up to Week 52|Phase 2 safety sample||particiapnts|||Number
161246|NCT00277212|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment|In order to be identified as clinically relevant abnormal, an on-drug value must meet the Criterion Value (CV) and also represent a change from the patient’s pretreatment value of at least the Change Relative to Baseline (CRB) magnitude. Heart Rate CV: 120 beats per minute (bpm), CRB: increase of ≥15 / CV: 50 bpm, CRB: decrease of ≥15. Systolic BP CV: 180 mmHg, CRB: increase of ≥20 / CV: 90 mmHg, CRB: decrease of ≥20. Diastolic BP CV: 105 mmHg, CRB: increase of ≥15 / CV: 50 mmHg, CRB: decrease of ≥15.|Up to 52 Weeks|Phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form).||participants|||Number
161247|NCT00277212|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment|Abbreviations and further description used in table: Sinus tachycardia, ≥120 beats per minute (bpm) and ↑ ≥15 bpm & no current diagnosis of supraventricular or ventricular tachycardia/atrial fibrillation (AF)/atrial flutter/ other rhythm abnormality. Sinus bradycardia, ≤ 50 bpm and ↓ 15 bpm & no current diagnosis of AF/atrial flutter/other rhythm abnormality. Supraventricular premature beat (SPB), Ventricular premature beat (VPB), Atroventricular (A-V). Other intraventricular block, QRS ≥0.12 sec and ↑ ≥0.02 sec & no current diagnosis of left or right bundle branch block.|Throughout the study, up to Week 52|Participants with ECG evaluation from the phase 2 Safety Sample (all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.)||particiapnts|||Number
161248|NCT00277212|Secondary|Adjusted Mean Change From Baseline in BMI by Study Week|Adjusted for index mood episode and baseline assessment.|Baseline, Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.||kg/m2||Standard Error|Mean
161249|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Gain by Study Week|Weight gain of at least a 7% increase from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.||Participants|||Number
161250|NCT00277212|Secondary|Number of Participants Showing Clinically Relevant Weight Loss by Study Week|Weight Loss of at least a 7% decrease from Baseline.|Weeks 12, 24, 36, 52|Observed cases (OC) data set (actual observation at each visit), Last observation carried forward (LOCF) data set (data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit), and Overall, Phase 2 Safety Sample; n=number assessed at given time point.||Participants|||Number
161251|NCT00277212|Secondary|Adjusted Mean Change From Baseline in Body Weight, Phase 2|Adjusted for index mood episode and baseline assessment|Baseline, Week 52|Participants from the phase 2 Safety Sample who had body weight evaluation at baseline and week 52 LOCF.||kg||Standard Error|Mean
161272|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Total-Cholesterol|Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
161273|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)|Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
163677|NCT00246376|Primary|Total Cholesterol|Total cholesterol (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dL||Standard Error|Mean
161252|NCT00277212|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Throughout Phase 2 (up to 52 weeks)|The Phase 2 Safety Sample comprises all patients who are randomized into Phase 2 and take at least one dose of double-blind medication in Phase 2, as indicated on the study therapy form.||participants|||Number
161253|NCT00277212|Secondary|Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Discontinuation Through Week 52(Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
161254|NCT00277212|Secondary|Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
161255|NCT00277212|Secondary|Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2|Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
161256|NCT00277212|Primary|Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)|Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).|Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Randomized Participants (comprises all patients who are randomized in Phase 2). n= number of randomized participants evaluated at given time point.||Proportion of Participants|||Number
161257|NCT00277095|Primary|Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.|The percentage of participants with 50% reduction in pad weight.|18 month follow-up|As followed analysis of all patients who were treated and reached the 18 month follow-up visit||percentage of patients||95% Confidence Interval|Number
161258|NCT00276861|Secondary|Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment|Number of months from time of enrollment to the date of first documented progression or date of death.|6 months|||months||95% Confidence Interval|Number
161259|NCT00276861|Primary|Response Rate as Measured by RECIST Criteria|Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.|4 - 6 months|||percentage of particpants||95% Confidence Interval|Number
161260|NCT00276614|Primary|Objective Response Rate as Measured by RECIST Criteria After Every 2 Courses of Treatment for up to 6 Courses||2 months|2 subjects were excluded from analysis as they completed less than 2 cycles of study therapy.||participants|||Number
161261|NCT00276549|Primary|Number of Patients With Measurable Soft Tissue Disease Will be Assessed Per Solid Tumor Response Criteria (RECIST).|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, patients who do not meet the criteria for response or progressive disease for at least 90 days will be categorized as stable disease.|at 4 weeks after treatment completion|25 patients had RECIST defined measurable disease at study entry. Confirmed response required 2 consecutive measurements at least 1 week later.Three patients did not have follow up measurements therefore were not evaluable.||participants|||Number
161262|NCT00276549|Primary|Objective PSA Response Rate (Number of Patients With a PSA Response)|Decline from a baseline value by ≥ 50% or normalization of PSA (< 0.03) confirmed by a second measurement at least 1 week or more weeks later. Patients must not demonstrate clinical or radiographic evidence of disease progression during this time period. The date of response will be defined as the first date at which the PSA declined from baseline by ≥ 50% or normalized.|every 4 weeks|All patients that received treatment.||participants|||Number
161263|NCT00276484|Secondary|Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6||6 Weeks|Full Analysis Set||Participants|||Number
161264|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)|Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
161265|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio|Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
161266|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio|Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
161267|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio|Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%|Baseline and 6 Weeks|Full Analysis Set||Percent change||95% Confidence Interval|Least Squares Mean
161274|NCT00276484|Secondary|Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)|Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set||Percent Change||95% Confidence Interval|Least Squares Mean
161275|NCT00276484|Primary|Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C|Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%|Baseline and 6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent Change||95% Confidence Interval|Least Squares Mean
161276|NCT00276458|Secondary|Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6||6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Participants|||Number
161277|NCT00276458|Post-Hoc|Percent Change in C-Reactive Protein (CRP) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161278|NCT00276458|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||percent||95% Confidence Interval|Least Squares Mean
161279|NCT00276458|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161280|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161281|NCT00276458|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161282|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161283|NCT00276458|Post-Hoc|Percent Change in Apolipoprotein A-I at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161284|NCT00276458|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161285|NCT00276458|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161286|NCT00276458|Secondary|Percent Change From Baseline in Total-Cholesterol at Week 6|([6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||percent||95% Confidence Interval|Least Squares Mean
161287|NCT00276458|Secondary|Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 Weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161288|NCT00276458|Secondary|Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161328|NCT00276094|Primary|Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12|||percentage of parabasal cells||Standard Deviation|Mean
161289|NCT00276458|Primary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6|[(6 week value – baseline value)/baseline value]*100%.|6 weeks|Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.||Percent||95% Confidence Interval|Least Squares Mean
161290|NCT00276419|Secondary|Mean Days of Pain During the 10 Week Treatment Periods|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. Mean number of days with pain during each 10 week treatment period will be calculated.|Approximately 12 weeks and at 24 weeks after randomization||||||
161291|NCT00276419|Primary|Severity of Breast Pain|Severity will measured using a 100 mm visual analog scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain severity VAS, 0 means no pain and 100 means extreme pain. The investigator measures the written mark of the participant in mm, and records this for the value of pain severity. The severity of breast pain will be determined by the mean of breast pain scores (determined for all days and for days for which pain is greater than 0) at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks||||||
161292|NCT00276419|Primary|Frequency of Breast Pain|Participants will complete a breast pain diary indicating the sensation of pain on a daily basis. The frequency of breast pain will be determined by the number of days per week that the subject recorded experiencing pain at 4 weeks and 10 weeks of each treatment.|4 weeks, 10 weeks||||||
161293|NCT00276406|Secondary|QTc Interval Before and After Treatment|The corrected QT interval (QTc) is a measurement of time (seconds) between the Q and T waves of an heart beat as recorded during an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)|||Milliseconds||Standard Error|Mean
161294|NCT00276406|Secondary|Heart Rate Before and After Treatment|Heart rate is the number of beats per minute, as recording on an Electrocardiogram (ECG).|Baseline period (9 days), Treatment period (7 days)|||beats per minute||Standard Error|Mean
161295|NCT00276406|Secondary|Stool Frequency Per Week|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Complete spontaneous bowel movements per week are reported. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||Number complete bowel movements per week||Standard Error|Mean
161296|NCT00276406|Secondary|Sense of Completely Emptying Bowels|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record whether or not they felt they had completely emptied their bowels(1= Yes; 0= No). Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||percentage of bowel movements||Standard Error|Mean
161297|NCT00276406|Secondary|Stool Ease of Passage|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool ease of passage of stool, according to the Bristol Stool Form Scale (ranging from 1 (manual disimpaction) to 7 (incontinence)). Only the 7 days at highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||units on a scale||Standard Error|Mean
161298|NCT00276406|Secondary|Stool Form/Consistency|"During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool consistency according to the Bristol Stool Form Scale (ranging from 1 (hard lumps) to 7 (watery)). The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|Daily during baseline period (9 days), Treatment period (7 days)|||units on a scale||Standard Error|Mean
161299|NCT00276406|Secondary|Stool Frequency Per Day|During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Only the 7 days of highest treatment dose will be used for comparison purposes.|Daily during baseline period (9 days), Treatment period (7 days)|||Number of bowel movements||Standard Error|Mean
161300|NCT00276406|Secondary|Colonic Geometric Center at 48 Hours (GC48) as Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC48 is the measurement taken at 48 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)|||units on a scale||Standard Error|Mean
161301|NCT00276406|Secondary|Colonic Filling at 6 Hours|The proportion of a radio-labeled meal in the colon at 6 hours (identifiable by radio-labelled tracer to capsule eaten with meal), measured by scintigraphy. This is an indirect measurement of small-bowel transit time.|Baseline period (9 days), Treatment period (7 days)|||percentage of meal||Standard Error|Mean
161302|NCT00276406|Secondary|Gastric Emptying Half-time (GE t1/2)|The measure of time for 50 percent of a radio-labeled meal to empty from the stomach.|Baseline period (9 days), Treatment period (7 days)|||minutes||Standard Error|Mean
161303|NCT00276406|Primary|Ascending Colon Emptying Half-time (AC t1/2) Measured in Hours|Calculated by linear interpolation of values on the AC emptying curve.|Baseline period (days 7-9 ), Treatment period (days 14-17)|||hours||Standard Error|Mean
161304|NCT00276406|Primary|Colonic Geometric Center at 24 Hours (GC24) Measured by Scintigraphy|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images of the abdomen are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC24 is the measurement taken at 24 hours after the radio-labeled meal.|Baseline period (days 7-9 ), Treatment period (days 14-17)|||units on a scale||Standard Error|Mean
161305|NCT00276250|Secondary|Number of Subjects With Normal Renal Function, as Measured by Serum Creatinine Levels|Renal function was assessed by measuring levels of serum creatinine. Normal values range from 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women.|24 months after transplant|One subject in the Efalizumab followed by abatacept regimen arm withdrew from the the study at 18 months post-transplantation and therefore did not have the 24-month assessments.||participants|||Number
161306|NCT00276250|Secondary|The Number of Study Participants Exhibiting a Successful Response to a Standard Mixed Meal Test, Measured by Stimulated C-peptide Levels After Islet Transplant.|The number of study participants who have detectable C-peptide levels after stimulation from a Mixed Meal Test. An increase of C-peptide indicates that insulin is being released normally in response to food consumption.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm for 18 and 24 months post-transplant||participants|||Number
161307|NCT00276250|Secondary|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels|The number of subjects exhibiting C-peptide levels ≥ 0.5 ng/mL was recorded.|1, 3, 6, 9,12,18 and 24 months post-transplantation|C-Peptide values were not obtained for 2 participants in the Efalizumab followed by abatacept arm at the 18 and 24 months post-transplant timepoints.||participants|||Number
161308|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 36 months after transplantation and the number of subjects with values < 6.5% was recorded which indicated better control of blood glucose levels.|36 months post-transplantation|Two participants in the Efalizumab followed by abatacept regimen arm were terminated prior to this time point due to islet graft failure; another one withdrew as they did not want to change to abatacept. The single participant in the Abatacept arm withdrew after graft failure which occurred at 6months post-transplantation.||participants|||Number
161309|NCT00276250|Secondary|Number of Subjects With HbA1C < 6.5%|HbA1C was assessed in the subjects 24 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|24 months post-transplant|One participant in the Efalizumab followed by abatacept regimen arm had partial graft function and withdrew from the study at 18 months post-transplantation (prior to this time point of assessment).||participants|||Number
161310|NCT00276250|Secondary|Number of Subjects With HbA1C Levels < 6.5%|HbA1C was assessed in the subjects 12 months after transplantation and the number of subjects with levels < 6.5% was recorded which indicated better control of blood glucose levels.|12 months post-transplantation|||participants|||Number
161311|NCT00276250|Secondary|Number of Subjects With HbA1C Less Than 6.5%|HbA1C was assessed in the subjects 6 months after transplantation and the number of subjects with values less than 6.5% was recorded which indicated better control of blood glucose levels.|6 months post-transplantation|The HbA1C for the subject in the abatacept arm was above the threshold (6.5%) for this measure.||participants|||Number
161312|NCT00276250|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 9, 12, 18, and 24 months following islet transplantation|1, 3, 6, 9,12,18 and 24 months post-transplantation|||participants|||Number
161313|NCT00276250|Primary|The Number of Insulin-independent Subjects at Day 75 (± 5 Days) Following the First Islet Cell Transplantation||75 days post-transplantation|||participants|||Number
161314|NCT00276159|Secondary|Peak Concentrations of 852A|Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.|Up to Week 12|Not able to analysis due to sale of agent - unable to perform.||ng/mL||Full Range|Mean
161315|NCT00276159|Secondary|Measure of Immune Activation With Correlative Laboratory Studies||Up to Week 12|Analysis not done to sale of agent - unable to perform.||IU/mL||Full Range|Mean
161316|NCT00276159|Secondary|Number of Patients Who Received Steroids|Number of patients who received steroids allowing successful continuation of therapy.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.||Participants|||Number
161317|NCT00276159|Primary|Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors|Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.|Up to Week 12|Includes patients receiving at least 12 doses of 852A study drug.||Participants|||Number
161318|NCT00276094|Secondary|Change From Baseline in Urinary Symptoms||Baseline (Randomization) to Week 12|||Participants|||Number
161319|NCT00276094|Secondary|Change From Baseline in Testosterone (Total) Levels||Baseline (Screening) to Week 12|||ng/dL||Standard Deviation|Mean
161320|NCT00276094|Secondary|Change From Baseline in Testosterone (Free) Levels||Baseline (Screening) to Week 12|||ng/dL||Standard Deviation|Mean
161321|NCT00276094|Secondary|Change From Baseline in Sex Hormone Binding Globulin Levels||Baseline (Screening) to Week 12|||nmol/L||Standard Deviation|Mean
161322|NCT00276094|Secondary|Change From Baseline in Luteinizing Hormone Levels||Baseline (Screening) to Week 12|||IU/L||Standard Deviation|Mean
161323|NCT00276094|Secondary|Change From Baseline in Follicle Stimulating Hormone Levels||Baseline (Screening) to Week 12|||IU/L||Standard Deviation|Mean
161324|NCT00276094|Primary|Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear||Baseline (Screening) to Week 12|||percentage of superficial cells||Standard Deviation|Mean
161325|NCT00276094|Secondary|Change From Baseline in Estradiol Levels||Baseline (Screening) to Week 12|"Analysis populations for each hormone:~Ospemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178"||pg/mL||Standard Deviation|Mean
161326|NCT00276094|Secondary|Change From Baseline in Severity of VVA Symptoms|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12|||Units on a scale||Standard Deviation|Mean
161327|NCT00276094|Secondary|Change From Baseline in Visual Evaluation of the Vagina|Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Screening) to Week 12|||Units on a scale||Standard Deviation|Mean
161330|NCT00276094|Primary|Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity|This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12|||Units on a scale||Standard Deviation|Mean
161331|NCT00276094|Primary|Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness|This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe|Baseline (Randomization) to Week 12|||Units on a scale||Standard Deviation|Mean
161332|NCT00276016|Secondary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.|"To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo~The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)|||Units on a scale||Standard Deviation|Mean
161333|NCT00276016|Primary|The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo|"To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing.~The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results."|Baseline to endpoint (6 hour period)|||Units on a scale||Standard Deviation|Mean
161334|NCT00275834|Secondary|Change in Blood Pressure||Baseline, 1 year|||mm Hg||95% Confidence Interval|Least Squares Mean
161335|NCT00275834|Secondary|Quality of Life as Measured by HADS_D|Hospital Anxiety and Depression Scale - Depression (HADS-D) The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|1 year|||units on a scale||95% Confidence Interval|Least Squares Mean
161336|NCT00275834|Secondary|Change in Lipids||baseline, 1 year|||mg/dL||95% Confidence Interval|Least Squares Mean
161337|NCT00275834|Secondary|Inflammatory Markers (CRP)|C reactive Protein (CRP)|1 year|Participants who had CRP testing completed||mg/L||Standard Error|Mean
161338|NCT00275834|Secondary|Waist Circumference|Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.|1 year|intent-to-treat||cm||95% Confidence Interval|Mean
161339|NCT00275834|Secondary|Proportions of Patients With 10% Weight Loss|This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.|1 year|||participants|||Number
161340|NCT00275834|Secondary|Proportions of Patients With 5% Weight Loss|These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.|1 year|||participants|||Number
161341|NCT00275834|Primary|Change in Body Weight|The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.|1 year|intent-to-treat||kg||95% Confidence Interval|Mean
161342|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.||Micrometers||Standard Deviation|Mean
161343|NCT00275821|Secondary|Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12|Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.|Baseline to Month 12|Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.||micrometers||Standard Deviation|Mean
161344|NCT00275821|Secondary|Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12|Fluorescein angiography was conducted in conjunction with color fundus photography at screening and at Months 6 and 12. Investigators used digital fluorescein angiograms to determine presence or absence of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).|Baseline to Month 12|The intent to treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.||mm^2||Standard Deviation|Mean
161345|NCT00275821|Primary|Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12|Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline to Month 12|Per-Protocol (PP) population includes a subset of patients from the Intent to Treat (ITT) population who completed Month 12/Visit 15, had an assessment of Best Corrected Visual Acuity in the study eye at Month 12/Visit 15 and did not have any major study protocol deviations.||letters||Standard Deviation|Mean
161347|NCT00275561|Secondary|Number of Participants With Partial or Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)? A partial symptom response was defined as an answer of yes to the above question and a decrease in severity of at least 2 levels, or a decrease in frequency of at least 1 level."|2 weeks|Analysis was run per protocol.||participants|||Number
161348|NCT00275561|Primary|Number of Participants With Complete Response to Dysphagia|"Measured by the Mayo Dysphagia Questionnaire, a validated 28 item instrument; 0=no dysphagia, higher levels indicate greater dysphagia severity. A complete symptom response was defined as an answer of no to the question In the past 2 weeks, have you had trouble swallowing, not associated with other cold symptoms (such as strep throat or mono)?"|2 weeks|Analysis was run per protocol.||participants|||Number
161349|NCT00275392|Secondary|Dynamic Visual Acuity|Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.|6 weeks|||LogMAR||Standard Deviation|Mean
161350|NCT00275392|Primary|Dynamic Gait Index|Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of < 20 indicates risk for falling.|6 weeks|Per-protocol analyses (i.e., only subjects who completed the intervention were included).||units on a scale||Standard Deviation|Mean
161351|NCT00275340|Secondary|Depressive Symptoms (Center for Epidemiologic Studies Depression Scale)||9 weeks||09/2009||||
161352|NCT00275340|Secondary|Function (Human Activity Profile)||9 weeks||09/2009||||
161353|NCT00275340|Secondary|Interference With Activities (Brief Pain Inventory-Interference Subscale)||9 weeks||09/2009||||
161354|NCT00275340|Secondary|Pain (McGill Pain Questionnaire-Short Form)||9 weeks||09/2009||||
161355|NCT00275340|Primary|Health-related Quality of Life (SF-36v2-acute Form)|The SF-36v2 yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.|9 weeks|||units on a scale||Standard Deviation|Mean
161356|NCT00275275|Secondary|Number of Dose Adjustments|Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.|Week 4|||number of adjustments||Standard Deviation|Mean
161357|NCT00275275|Primary|Adverse Effects Experienced|Number of adverse effect experienced by participants in the different conversion ratio groups.|Week 4|||number of events|||Number
161358|NCT00275262|Primary|Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||spots/1 million cells||Standard Deviation|Mean
161359|NCT00275262|Primary|Mean Change From Baseline in IgG1 Response (Mcg/mL) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgG1 antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgG1 concentration before the KLH vaccination. Change from baseline was calculated as the IgG1 value postvaccination minus the IgG1 value at baseline.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgG1. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||mcg/mL||Standard Deviation|Mean
161360|NCT00275262|Secondary|Mean Change From Baseline in TREC Per 100,000 CD8+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD8+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD8+ cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010~The change from baseline is defined as posttransplant TREC/100,000 CD8+ cells minus pretransplant TREC /100,000 CD8+ cells."|Pretransplant and posttransplant (Month 12)|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD8+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||TREC /100,000 CD8+ cells||Standard Deviation|Mean
161361|NCT00275262|Secondary|Mean Change From Baseline in T Cell Excision Circles (TREC) Per 100,000 CD4+ Cells to Final Visit in Patients Treated With LAD (11.25 mg) or Placebo After Transplant|"CD4+ cells are a type of T cell. T cells are produced in the thymus and thymic function can be determined by TREC. By counting the number of TRECs present (only 1 copy per cell) within a population of CD4 cells, an assessment of T cell recovery and immune response is obtained. Mayo Medical Clinic. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/87959. Accessed 17 MARCH 2010~The change from baseline is defined as posttransplant TREC/100,000 CD4+ cells minus pretransplant TREC /100,000 CD4+ cells."|Pretransplant and posttransplant (Month 12)|Nine subjects from the LAD-treated arm and 7 subjects from the placebo-treated arm were assessed for TREC per 100,000 CD4+ cells. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||TREC /100,000 CD4+ cells||Standard Deviation|Mean
161362|NCT00275262|Primary|Mean Change From Baseline in IgM Response (Mcg/mL) Before Keyhole Limpet Hemocyanin (KLH) Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo|Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Serum immunoglobulin IgM antibodies were determined by enzyme-linked immunosorbent assay (ELISA). Baseline is defined as the IgM concentration before the KLH vaccination. Change from baseline was calculated as the IgM value postvaccination minus the IgM value at prevaccination.|Month 6 prevaccination (baseline) and Month 7 postvaccination|Eight subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for IgM. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.||mcg/mL||Standard Deviation|Mean
161363|NCT00275028|Secondary|Progression-free Survival||Up to 2 years|||weeks||Standard Error|Mean
161364|NCT00275028|Primary|Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST)~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|Up to 12 months|||participants|||Number
161365|NCT00275002|Secondary|Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide|Clinical and laboratory studies to assess adverse events are obtained at least every four weeks (prior to each course) with some laboratory studies obtained every 2 weeks. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Attribution of each adverse event to the treatment regimen is determined by the participant's attending physician at the enrolling institution and verified by the study chair.|From day 1 of therapy up to 49 months|Participants who received at least one day of the treatment regimen were included in the analysis of this objective.||Participants|||Number
161366|NCT00275002|Primary|Percentage of Participants With an Objective Response (Complete Response or Partial Response)|The primary endpoint is to assess the percentage of participants with a sustained objective response (complete response (CR) or partial response (PR)). Response is assessed by magnetic resonance imaging (MRI) per the following criteria: CR - disappearance of tumor and PR - ≥50% reduction in tumor based on the maximal cross-sectional measurements. The response must be sustained for at least 8 weeks, and the date of the confirmed sustained response is the date at which the response was first noted by MRI.|Week 8, 16, 24, 32, and 40 after starting therapy|Participants included in assessing objective response were those who completed two courses of therapy or those who died or experienced progressive disease prior to completing the second course.||Percent of Participants||95% Confidence Interval|Number
161367|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.|Weight of unstimulated saliva production in grams|At study enrollment|Twenty-nine patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of unstimulated saliva production||Grams of saliva||Standard Deviation|Mean
161368|NCT00274937|Secondary|Protective Effects of Amifostine Assessed Primarily by Sialometry|Weight of stimulated saliva production in grams.|At study enrollment|Twenty-six patients in stratum 2 were evaluated at both study enrollment and at the end of consolidation for the weight of stimulated saliva production||Grams of saliva||Standard Deviation|Mean
161369|NCT00274937|Secondary|Predictive Value of the Detection of EBV DNA in the Peripheral Blood|The prognostic value of the presence of EBV DNA will be assessed using the log-rank test, adjusted by initial stage of disease, if appropriate. The proposed analysis will take place at the analytic endpoint of the clinical trial.|Up to 6 years|Samples have been collected and funding is being sought to perform the necessary laboratory evaluations.|||||
161370|NCT00274937|Secondary|Prognostic Significance of EBV Viral Load|Viral load in blood.|At study enrollment|Samples have been collected and funding is being sought to perform the necessary laboratory evaluations.|||||
161371|NCT00274937|Secondary|Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment|Presence of EBV DNA in serum.|At study enrollment|Samples have been collected and funding is being sought to perform the necessary laboratory evaluations|||||
161372|NCT00274937|Primary|Two Year Event-free Survival (EFS)|The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.|Up to two year after enrollment|||Estimated probability||95% Confidence Interval|Number
161373|NCT00274924|Secondary|5-year Overall Survival|5-year overall survival is defined as the probability of patients who remain alive at 5 years from study entry. The method of Kaplan and Meier (1958) was used to estimate overall survival.|Every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.|||probability||90% Confidence Interval|Number
161374|NCT00274924|Primary|2-year Progression-Free Survival (PFS)|2-year progression-free survival is defined as the probability of patients who remain alive and progression free at 2 years from study entry. The method of Kaplan and Meier (1958) was used to estimate PFS.|Assessed every 4 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then every 12 months if patient is 5-10 years from study entry.|||probability||90% Confidence Interval|Number
161375|NCT00274846|Secondary|Number of Patients With Complete Remission and Natural Killer Cell Expansion|Includes patients who had both a complete remission of disease and an expansion of natural killer cells.|Day 14|Unable to evaluate due to low complete remission rate.|||||
161376|NCT00274846|Secondary|Overall Survival Time of Patients With Complete Remission|Median number of months patients were alive after NK cell infusion.|From Day 1 of Treatment until death or patient received bone marrow transplant.|||Months||Full Range|Median
161377|NCT00274846|Secondary|Median Time to Disease Relapse (Months)|Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood.|From 1st Day of treatment until death or receipt of bone marrow transplant.|Only 2 of 20 patients that received adequate Natural Killer Cells achieved complete remission, and were therefore evaluable for the time to relapse endpoint.||Months||Full Range|Median
161378|NCT00274846|Secondary|Number of Patients With Complete Remission|Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery).|Day 28-35|||Participant|||Number
161379|NCT00274846|Primary|Number of Patients With Natural Killer (NK) Cell Expansion|Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).|Study Day 14|||Participants|||Number
161380|NCT00274781|Secondary|Tolerability|Tolerability of Therapy was assessed through use of the National Cancer Institute Common Toxicity Criteria (version 3.0). Treatment tolerability was determined based upon whether or not the physician determined therapy was in the patient's best interest, whether the patient wanted to continue therapy or not, whether patients discontinued treatment due to progressive disease, or whether patients discontinued treatment due to toxicity.|12 Weeks|||participants|||Number
161381|NCT00274781|Secondary|Overall Survival|Patient's Overall Survival from date of enrollment to a minimum of three years for survival.|From date of enrollment to a minimum of three years for survival|||months||Full Range|Median
161382|NCT00274781|Primary|Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)|The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is <10%. A total of >/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses.|at 12 weeks post treatment|Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12)||percentage of patients|||Number
161383|NCT00274768|Secondary|Adherence and Compliance to Oral Medication Using Electronic Monitoring||Every 3 weeks||||||
161384|NCT00274768|Secondary|Pharmacokinetic and Pharmacodynamic Effects||Time to progression||||||
161385|NCT00274768|Secondary|Clinical Benefit, Time to Treatment Failure, Safety and Toxicity||Time to progression||||||
161386|NCT00274768|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Participants were followed to progression, evaluated every 12 weeks|Any participant who completed at least one (1) cycle of capecitabine administration was evaluable for response.||participants|||Number
161387|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (With Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Minimal response was treated as a separate response category in this analysis. Best clinical response was defined as the best response achieved during the course of the study, whereby the following order was applied: Complete Response, Complete Response Unconfirmed, Partial Response, Minimal Response, Stable Disease, and Progressive Disease.~If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab||participants|||Number
161388|NCT00274742|Secondary|Objective Tumor Response According to the Cheson Criteria (Without Minimal Response)|"Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration).~Best clinical response is defined as the best response achieved during the course of the study, with response defined as: Complete Response, Complete Response Unconfirmed, Partial Response, Stable Disease, and Progressive Disease. In this analysis minimal response is set to stable disease as intended in the response categories according to the Cheson criteria. An independent external review by a radiologist (computed tomography scans) and a pathologist (biopsies) was performed to confirm response status.~If no post-baseline tumor assessment was available, the overall clinical response was set to not available."|Assessed after 4 and 8 weeks of treatment|All participants who received at least one infusion of blinatumomab||participants|||Number
161389|NCT00274742|Secondary|Serum Concentration of Blinatumomab|The steady state serum concentration (Css), summarized as the observed concentrations collected at least 10 hours after the start of continuous intravenous infusion or within the sampling window at the end of infusion. Concentrations below the lower limit of quantitation (100 pg/mL) were excluded from analysis.|Up to 24 hours after the end of infusion.|Participants who received blinatumomab and had available pharmacokinetic data||pg/mL||Standard Deviation|Mean
161390|NCT00274742|Primary|Number of Participants With Adverse Events|Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events|From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days.|All participants who received at least one infusion of blinatumomab||participants|||Number
161424|NCT00274287|Primary|Time to Disease Progression (TTP)|The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically.|time to disease progression (up to 6 months)|Per protocol.||months||Full Range|Median
171562|NCT00113425|Primary|Change From Baseline in Pustule Acne Lesions at Week 10||Baseline and Week 10|||pustule acne lesions||95% Confidence Interval|Mean
161391|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
161392|NCT00274716|Primary|Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
161393|NCT00274716|Primary|Number of Participants Who Reported a Laboratory Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
161394|NCT00274716|Primary|Number of Participants Who Reported a Clinical Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.|24 weeks|All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.||Participants|||Number
161395|NCT00274716|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)|TG measured at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||Percent change||Standard Deviation|Mean
161396|NCT00274716|Secondary|Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI|HDL-C measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||Percent change||Standard Deviation|Mean
161397|NCT00274716|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)|LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||percentage change||Standard Deviation|Mean
161398|NCT00274716|Secondary|Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI|Waist circumference measured in cm at baseline and after 12 weeks of study drug administration|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||cm||Standard Deviation|Mean
161399|NCT00274716|Secondary|Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI|Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||kg||Standard Deviation|Mean
161400|NCT00274716|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||mm Hg||Standard Deviation|Mean
161425|NCT00274261|Secondary|Incidence of Adverse Events.|Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.|The DSMB will review safety data at 3 months following 200 subjects enrolled, 3 months following 400 subject enrolled, as well as additional meetings as needed.||||||
163678|NCT00246376|Primary|HDL-C|HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dl||Standard Error|Mean
161401|NCT00274716|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)|Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.|Baseline and Week 12 (end of Phase A)|Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.||mm Hg||Standard Deviation|Mean
161402|NCT00274651|Post-Hoc|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals||participants|||Number
161403|NCT00274651|Secondary|Duration of Response|Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.|throughout the study, or for a maximum of 2 years|Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days||Days||Full Range|Median
161404|NCT00274651|Secondary|Time to Response|Time to response was defined as the interval between the first date of treatment and the first notation of response.|throughout the study, or for a maximum of 2 years|Time to response (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. For 4 patients with CTCL and 6 patients with PTCL, response was recorded. The median time to response and the full range (days) are presented.||Days||Full Range|Median
161405|NCT00274651|Secondary|Time to Progression|Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.|throughout the study, or for a maximum of 2 years|Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.||Days||Full Range|Median
161406|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))|Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.|throughout the study, or for a maximum of 2 years|Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama & Chen (2008) are presented||percentage of patients with OR|||Number
161407|NCT00274651|Primary|Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)|Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.|throughout the study, or for a maximum of 2 years|At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals|||||
161408|NCT00274625|Primary|Incisional Hernia|An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.|2 years|14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.||participants|||Number
161409|NCT00274469|Secondary|Duration of Clinical Benefit|Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.Time from randomization until earlier of disease progression or death measured only in those patients who achieved clinical benefit.|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|143 of the 205 patients on the study had clinical benefit. Of those 143 patients, 23 subsequently progressed.||Number of CB patients progressed|||Number
161410|NCT00274469|Secondary|Duration of Response|Time from randomization until earlier of progression or death measured only in those patients who achieved a confirmed Complete Response or confirmed Partial Response.|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|65 of the 205 patients on the study had confirmed RECIST response. Of those 65 responding patients, 14 subsequently progressed.||Number of responders who progres|||Number
161411|NCT00274469|Secondary|Time to Progression|Time from randomization until earlier of disease progression or death|RECIST tumour assessments carried out every 12 weeks from randomization (+/- 2 weeks) until data cut-off on 10th January 2008.|73 of the 205 patients on the study had progressed at the time of data cut-off.||Number of patients who progressed|||Number
161412|NCT00274469|Secondary|Objective Response Rate|An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CRif she had overall response of CR or PR on one visit and met the confirmation criteria perRECIST. ORR is defined as percentage of patients with objective response.|Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.|||Percentaage||Standard Deviation|Mean
161509|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 48|Mean change from baseline in BMI at Week 48 was determined.|Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||kg/m^2||Standard Error|Mean
161413|NCT00274469|Primary|Clinical Benefit Rate|A Clinical Benefit (CB) responder is defined as a patient having a best overall response ofCR, PR or SD provided SD (or better) was present ≥ 154 days from randomization (ie SD ≥ 24weeks with the 2 week RECIST assessment time window allowed). The Clinical Benefit Rate is the percentage of patients with CB.|Each patient was assessed for Clinical Benefit from the sequence of RECIST (Response Evaluation Criteria In Solid Tumours) scan data up to data cut-off, 10th Jan 2008. RECIST scans were performed every 12 weeks (+/- 2 weeks) from randomization.|||Percentage||Standard Deviation|Mean
161414|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Hemoglobin (Hb) Counts|Maximal degree of myelosuppression is represented by the nadir in hemoglobin (Hb) measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.||g/L||Standard Deviation|Mean
161415|NCT00274456|Secondary|Participants With Treatment-Emergent, Treatment-Related Adverse Events|Summary of participants who had treatment-emergent that were treatment-related in the opinion of the investigator, and summarized in a variety of categories. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||participants|||Number
161416|NCT00274456|Other Pre-specified|Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts|Maximal degree of myelosuppression is represented by the nadir in absolute neutrophil (ANC), white blood cell (WBC), and platelet measurements over all treatment cycles.|Day 1 up to 125 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug, and had blood tests performed following treatment. Three participants dropped out after a single dose so have no post-treatment lab values.||10^9/L||Standard Deviation|Mean
161417|NCT00274456|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Participant survival was defined as the date of randomization to the date of death. Participants that were alive at the time of analysis were censored at the last known time that the participant was alive. The final analysis of mature overall survival was conducted after 2 years of follow-up (data cutoff date 31 Jan 2010).|Day 1 to 221 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||months||95% Confidence Interval|Median
161418|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The investigator assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.||months||95% Confidence Interval|Median
161419|NCT00274456|Secondary|Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression|Duration of response was measured as the progression-free survival on patients with confirmed response. The independent radiology assessment is offered here. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000) and is defined in outcome #1. Progression-free survival is defined in outcome #3.|Day 1 - 95 weeks|Patients with a confirmed CR or PR were included in this analysis. Patients who did not progress or die were censored at the last known time when patient was progression free. Patients who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.||months||95% Confidence Interval|Median
161420|NCT00274456|Secondary|Kaplan-Meier Estimates for Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the start of disease progression (PD) or patient death (any cause), whichever occurred first. Patients without disease progression were censored at the last time the patient was known to be progression-free. Patients who initiated new anticancer therapy prior to documented progression or death were censored at the start of new therapy. Disease progression was assessed separately by investigators and by an independent radiologist. Both assessments are offered. Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (Therasse, 2000). PD for target lesions is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||months||95% Confidence Interval|Median
161421|NCT00274456|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response|Known as the disease control rate, this outcome measures the percentage of participants with stable disease for 16 weeks or more, or had a confirmed complete or partial response (see outcome #1 for confirmed response definitions). Assessments made by independent radiology and by investigators are reported separately|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||percentage of participants||95% Confidence Interval|Number
161422|NCT00274456|Primary|Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator|Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is >= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.|Day 1 up to 95 weeks|The treated population consisted of all randomized participants who received at least one dose of study drug||percentage of participants||95% Confidence Interval|Number
167625|NCT00162266|Primary|Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
161426|NCT00274261|Primary|The Cumulative Probability of Typical-use 6 Month (183 Days) Pregnancy.|Number of pregnancies in women using C31G gel for 6 months (183 days) compared to women using Conceptrol gel for the same time frame.|6 months|Modified Intent-To-Treat (MITT): ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as “Typical-Use”) and for whom there is at least one report of pregnancy status.||6 month probability of pregnancy||95% Confidence Interval|Number
161427|NCT00273910|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|48 months|||Participants|||Number
161428|NCT00273910|Primary|Immunologic Response Rate|Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.|48 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.||Participants|||Number
161429|NCT00273858|Secondary|Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month|PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.||mm|||Number
161430|NCT00273858|Secondary|Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month|PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.|Baseline, Month 24|Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.||Millimetre (mm)|||Number
161431|NCT00273858|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.|Baseline, Month 24|Data was not analyzed as the usage of the questionnaire was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.||Units on a Scale|||Number
161432|NCT00273858|Primary|Number of Participants by Reasons for Discontinuation of Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.||Participants|||Number
161433|NCT00273858|Primary|Number of Participants Who Discontinued Treatment||Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.||Participants|||Number
161434|NCT00273858|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 24|Safety population included all participants who received at least one dose of etanercept.||Participants|||Number
161435|NCT00273793|Secondary|Average Number Cigarettes Reported Smoked Each Day in the Past Week Measured at Follow-up Six Months After Entry Into the Study|average number cigarettes reported smoked each day in the past week at follow up six months after study entry|past week at follow-up six months after study entry|||cigarettes per day||Standard Deviation|Mean
161436|NCT00273793|Primary|Breath Carbon Monoxide Levels Indicating Smoking Abstinence During the Study, i.e., the Number of Breath Samples With Carbon Monoxide (CO) Levels Less Than 3 Parts Per Million (Ppm)||daily for breath CO|all subjects randomized to condition||number breath samples < 3 ppm CO||Inter-Quartile Range|Median
161437|NCT00273754|Secondary|Hospital Discharge Time|Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.|Total time from end anesthesia to discharge home|||Minutes||Standard Deviation|Mean
161438|NCT00273754|Secondary|Post Anesthesia Care Unit (PACU) Duration||Time spent in PACU following surgical procedure prior to discharge home or hospital admission.|||minutes||Standard Deviation|Mean
161439|NCT00273754|Secondary|Awakening Time|A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.|Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.|||Minutes||Standard Deviation|Mean
161440|NCT00273754|Secondary|Extubation Time.|Time from end of anesthesia until extubation.|Duration from anesthesia end until extubation time.|||minutes||Standard Deviation|Mean
161441|NCT00273754|Secondary|Occurence of Post Extubatory Respiratory Adverse Events.|The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|Per protocol||Participants|||Number
161442|NCT00273754|Primary|Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.|The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.|Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.|The analysis was per protocol.||Participants|||Number
161443|NCT00273182|Secondary|Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant|"A left ventricular lead related complication is defined as an adverse event that requires invasive intervention or leads to loss of significant device function resulting from the presence or performance of the LV lead.~Kaplan-Meier method was used to estimate complication-free rate during the three years of follow-up. Time to the first post-implant LV lead related complication was used for the calculation. Confidence intervals were calculated on a log-log scale."|36 months follow-up|The analysis included data from all subjects enrolled in the InSync Registry study.||participants|||Number
161444|NCT00273182|Secondary|Left Ventricular (LV) Lead Pacing Voltage Threshold|Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up|36 months follow-up|||Volts||95% Confidence Interval|Mean
161445|NCT00273182|Secondary|Left Ventricular (LV) Lead Impedance|Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.|36 months follow-up|||ohms||95% Confidence Interval|Mean
161446|NCT00273182|Secondary|Left Ventricular (LV) Lead R-wave Amplitude|Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.|36 month follow-up|1999 subjects successfully implanted with a left ventricular lead as part of a Medtronic CRT/CRT-D system.||mV||95% Confidence Interval|Mean
161447|NCT00273182|Primary|Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.|Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules|36 month follow-up|The analysis included data from all subjects enrolled in the InSync Registry study and successfully implanted with the InSync or InSync III system.||participants|||Number
161448|NCT00273052|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
161449|NCT00273052|Secondary|Change From Baseline in Homeostasis Model Assessment (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||Percent Change|||Number
161450|NCT00273052|Secondary|Change From Baseline in c-Peptide (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||ng/mL|||Number
161451|NCT00273052|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||Percent Change|||Number
161452|NCT00273052|Secondary|Change From Baseline in Fasting Insulin (Glycemic Parameter) by Treatment Group at Maintenance Month 6|Blood draw for glycemia levels. Full beta Quant test performed. Test for Fasting plasma glucose, HbA1c, fasting insulin. Homeostasis model Assessment (HOMA) is a computer-generated model consisting of non-linear empirical equations solved numerically to predict glucose, Insulin and C-peptide concentrations in fasting subjects for insulin sensitivity (%S). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||uIU/mL|||Number
161453|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of g/L at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||g/L|||Number
161795|NCT00268463|Secondary|Scales Specific to Social/Family, Emotional, and Functional Well-being, Perceived Convenience of Care, and Self-reported Symptoms||Prior to randomization, 4-6 weeks after surgery, 18 weeks after starting chemotherapy and after completion of chemotherapy||||||
161454|NCT00273052|Secondary|Change From Baseline in Additional Lipid Parameters by Treatment Group With Unit of Measures of mg/dL at Maintenance Month 6|Blood draw for lipid levels. Full beta Quant test performed with HDL subclasses and IDL. IDL=Intermediate density lipoproteins, LDL=Low-density lipoprotein, VLDL=Very Low density lipoprotein, HDL=High-density lipoprotein. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
161455|NCT00273052|Secondary|Change From Baseline in Weight by Treatment Group at Maintenance Month|Manual physical examination. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||kg|||Number
161456|NCT00273052|Secondary|Change From Baseline in Heart Rate by Treatment Group at Maintenance Month 6|Manual physical examination. Change = Month 6 value minus Baseline value. (BPM=beats per minute)|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||bpm|||Number
161457|NCT00273052|Secondary|Change From Baseline in Blood Pressure by Treatment Group at Maintenance Month 6|Manual physical examination (cuff blood pressure). Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mm Hg|||Number
161458|NCT00273052|Secondary|Change From Baseline in Log Transformed Lipoprotein-associated Phospholipase A2 (LpPLA2) by Treatment Group at Maintenance Month 6|Blood draw for LpPLA2 activity. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mcmol/min/L|||Number
161459|NCT00273052|Secondary|Change From Baseline in Log Transformed High Sensitivity C-reactive Protein (Hs-CRP) by Treatment Group at Maintenance Month 6|Blood draw for hs-CRP. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
161460|NCT00273052|Primary|Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) Levels by Treatment Group at Maintenance Month 6|Blood draw for HDL-C levels. Full beta Quant test performed with HDL subclasses. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
161461|NCT00273052|Primary|Change From Baseline in Triglycerides Levels by Treatment Group at Maintenance Month 6|Blood draw for triglyceride levels. Full beta quantification test performed which uses ultracentrifugation to partially separate lipoprotein classes and is the basis for the reference methods. Change = Month 6 value minus Baseline value.|Baseline and Month 6|The Intent to Treat (ITT-E) Population was used for analysis of the efficacy results and consisted of all subjects who randomized, received at least one dose of study medication, and had both a baseline and at least one on-therapy value for an efficacy parameter during the maintenance phase(number of participants will vary between measures).||mg/dL|||Number
161462|NCT00272987|Secondary|Progression-free Survival as Assessed by the Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who do not progress, or die, progression-free survival was censored at the time of the last investigator assessed radiological scan preceding the initiation of any alternative anti-cancer therapy. Progression-free survival was summarized using Kaplan-Meier curves.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 164)|Safety Population||Weeks||95% Confidence Interval|Median
161463|NCT00272987|Secondary|Number of Participants With Clinical Benefit (CR, PR, and Stable Disease [SD] for at Least 24 Weeks) as Assessed by Investigator|Clinical benefit is defined as the numer of participants achieving either a CR or PR or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions), taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR or SD until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population||Participants|||Number
161510|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 96|Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||ratio||Standard Error|Mean
161796|NCT00268463|Secondary|Survival as Measured by Time to Death From Any Cause.||Time from randomization through year 5||||||
161797|NCT00268463|Secondary|Liver PFI as Measured by Time to Hepatic Progression.||Time from randomization through year 5||||||
161464|NCT00272987|Primary|Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST). The best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 164)|Safety Population||Percentage of participants|||Number
161465|NCT00272987|Secondary|Duration of Response (DoR), as Assessed by the Investigator|DoR is defined for the subset of participants who had a confirmed CR (disappearance of all TLs and non-TLs) or PR (>=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs. For participants who did not progress or die, DoR was censored on the date of the last radiological scan. If a participant had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.||Weeks||Inter-Quartile Range|Median
161466|NCT00272987|Secondary|Time to Response as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 164)|Safety Population. Only those participants with CR or PR were analyzed.||Participants|||Number
161467|NCT00272987|Primary|Number of Participants Who Received Any Concomitant Medications During the Study Period|Number of participants who received any concomitant medication along with study drugs (lapatinib, trastuzumab and paclitaxel) were counted during the treatment period.|withdrawal/study completion (up to Study Week 164)|Safety Population||Participants|||Number
161468|NCT00272987|Primary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value|The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
161469|NCT00272987|Primary|Number of Events of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics|Events of left ventricular ejection fraction (LVEF) decrease were characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. A participant could have been counted in more than one category.|Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only the participants with at least one of event of LVEF decrease were analyzed.||Events|||Number
161470|NCT00272987|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Degree Celsius||Standard Deviation|Mean
161511|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 48|Mean change from baseline in waist circumference at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||cm||Standard Error|Mean
161798|NCT00268463|Primary|Progression-free Interval (PFI)|Time to first recurrence of colon cancer at any site|Time from randomization through year 5||||||
161471|NCT00272987|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate was measured at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Beats per minute (BPM)||Standard Deviation|Mean
161472|NCT00272987|Primary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and every 4 weeks thereafter up to withdrawal/study completion and at the 30 day follow-up visit. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Millimeter of mercury (mmHg)||Standard Deviation|Mean
161473|NCT00272987|Primary|Number of Events of Hepatotoxicity With the Indicated Characteristics|Events of hepatotoxicity are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one of event of hepatotoxicity were analyzed.||Events of hepatotoxicity|||Number
161474|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Clinical chemistry parameters included values > upper limit of normal (ULN)=Hyper; values < lower limit of normal (LLN)=Hypo of sodium (Hypernatraemia and Hyponatraemia), potassium (Hyperkalaemia and Hypokalaemia), calcium (Hypercalcaemia and Hypocalcaemia), glucose (Hyperglycaemia and Hyperglycaemia), creatinine (if >2 milligram per deciliter [mg/dL]), aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phophatase, total bilirubin (if available bilirubin fractionation is recommended if the total bilirubin is > twice of ULN), and albumin. Clinical chemistry data was summarized by National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the safety population.||Participants|||Number
161475|NCT00272987|Primary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters|Blood samples for clinical laboratory evaluation were taken at Baseline prior to the administration of investigational product and thereafter at each scheduled visit. Haematology parameters included haemoglobin, total white blood cell count (WBC), neutrophils, lymphocytes and platelets. Hematology data was summarized by the National Cancer Institute's Common toxicity criteria for adverse events (NCI CTCAE) toxicity grade (Version 3.0). Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death.|Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up (up to Study Week 164)|Safety Population||Participants|||Number
161476|NCT00272987|Primary|Number of Events of Diarrhea With the Indicated Characteristics|Events of diarrhea are characterized as serious, related to investigational product, leading to withdrawal from the study and fatal. Participants could have been counted in more than one category.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population. Only the participants with at least one event of diarrhea were analyzed.||Events of diarrhea|||Number
161477|NCT00272987|Primary|Number of Participants Who Died Due to Any Cause|Number of participants who died due to any cause during the study or after completion of study were reported.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population||Participants|||Number
161478|NCT00272987|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to Study Week 164)|Safety Population||Participants|||Number
161479|NCT00272987|Primary|Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the investigational product up to withdrawal/study completion (up to Study Week 164)|Safety Population: all participants who were randomized and received at least one dose of investigational product.||Weeks||Standard Deviation|Mean
161512|NCT00272779|Secondary|Mean Change From Baseline in Waist Circumference at Week 96|Mean change From baseline in waist circumference at Week 96 was determined.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||cm||Standard Error|Mean
161513|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96||Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.||kg/m^2||Standard Error|Mean
161480|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
161481|NCT00272961|Secondary|Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
161482|NCT00272961|Secondary|Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
161483|NCT00272961|Secondary|Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.|Pre-Dose and 2 hours Post-Dose on Week 10|FAS:all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure.||mmHg||Standard Error|Least Squares Mean
161484|NCT00272961|Secondary|Standing Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
161485|NCT00272961|Secondary|Sitting Diastolic Blood Pressure (DBP)|DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
161486|NCT00272961|Secondary|Standing Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|FAS: all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. Here “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
161487|NCT00272961|Secondary|Sitting Systolic Blood Pressure (SBP)|SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant’s non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.|Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10|Full analysis set (FAS):all randomized participants who received study treatment at least twice after Placebo Run-in Phase, but not necessarily at 2 consecutive visits. “N” (number of participants analyzed): participants evaluable for this measure, n: participants with non-missing value for specified time-point for each treatment arm, respectively.||mmHg||Standard Error|Mean
161488|NCT00272961|Primary|Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change|AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set: all participants who received at least 1 dose of study treatment. “N”(number of participants analyzed): participants evaluable for this measure and n: participants with non-missing baseline and at least 2 non-missing values in treatment phase or in follow-up for specified category for each treatment arm, respectively.||mmHg||Standard Error|Least Squares Mean
161489|NCT00272961|Primary|Maximum Blood Pressure (BP) Increase|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.|Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12|Safety analysis set included all participants who received at least 1 dose of study treatment. Here “n” signifies participants evaluable for specified category for each treatment arm, respectively.||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
161490|NCT00272792|Secondary|Change in Phenylalanine Levels From Baseline to Week 3||Baseline to Week 3|||umol/L||Standard Error|Mean
161491|NCT00272792|Primary|Amount of Dietary Supplemented Phenylalanine (Phe)Tolerated in Children With Phenylketonuria||at Week 10|||mg/kg/day||Standard Deviation|Mean
161492|NCT00272779|Primary|Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
161493|NCT00272779|Primary|Mean Change From Baseline in VAT Associated With RETN_730|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
161494|NCT00272779|Primary|Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
161495|NCT00272779|Primary|Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||cm^2||Standard Error|Mean
161496|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||pg/mL||Standard Error|Mean
161497|NCT00272779|Primary|Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||pg/mL||Standard Error|Mean
161498|NCT00272779|Primary|Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||ng/dL||Standard Error|Mean
161499|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
161500|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
161501|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
161502|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
161503|NCT00272779|Primary|Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
161504|NCT00272779|Primary|Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097|The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.|Baseline (Day 1), Week 48, and Week 96.|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.||mg/dL||Standard Error|Mean
161505|NCT00272779|Secondary|Mean Change From Baseline in BMI at Week 96|Mean change From baseline in BMI at Week 96 was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and with values for this parameter.||kg/m^2||Standard Error|Mean
161506|NCT00272779|Secondary|Mean Changes From Baseline in Body Weight at Week 96|Mean change in body weight from baseline was determined.|Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||kg||Standard Error|Mean
161507|NCT00272779|Secondary|Percentage of Participants With Lipoatrophy at Week 96|Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||percentage of participants|||Number
161508|NCT00272779|Secondary|Mean Change From Baseline in Waist-to-hip-ratio at Week 48|Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||ratio||Standard Error|Mean
161514|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 48|Mean change from baseline in body weight at Week 48 was determined.|Baseline (Day 1) and Week 48|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.||kg||Standard Error|Mean
161515|NCT00272779|Secondary|Mean Change From Baseline in Body Weight at Week 96|Mean change from baseline in weight at Week 96|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.||kg||Standard Error|Mean
161516|NCT00272779|Secondary|Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|Baseline (Day 1) and Week 96|As-treated participants in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.||g/cm^2||95% Confidence Interval|Mean
161517|NCT00272779|Secondary|Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48|Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.|DEXA scans were taken at Baseline (Day 1) and Week 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||grams/ centimeters ^2 (g/cm^2)||95% Confidence Interval|Mean
161518|NCT00272779|Secondary|Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA||Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Ratio||95% Confidence Interval|Mean
161519|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Percentage||95% Confidence Interval|Mean
161520|NCT00272779|Secondary|Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48|The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.|DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Percentage||95% Confidence Interval|Mean
161521|NCT00272779|Secondary|Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.|DEXA scans were taken at Baseline (Day 1) and at Weeks 48.|As-treated participants (with values for this parameter)in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.||Ratio||Standard Error|Mean
161522|NCT00272779|Secondary|Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96|Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 96.|"Resistance analysis are based on randomized population. 2 subjects with baseline phenotypic resistance to ATV/RTV are excluded. Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. n signifies the number of participants evaluable for each parameter."||Participants|||Number
161523|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161524|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161525|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96|Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161562|NCT00272779|Secondary|Mean Change in Fasting Lipid at Week 48|Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population.||milligrams/deciliter (mg/dL)||Standard Error|Mean
161526|NCT00272779|Primary|Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis|19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].|Baseline visit|Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. The Hardy-Weinberg Equilibrium test was used to check for the genotype quality. All SNPs passed the quality check.||participants|||Number
161527|NCT00272779|Primary|Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.|Baseline (Day 1) and Week 96.|As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.||Ratio||Standard Error|Mean
161528|NCT00272779|Primary|AUC (TAU) of Tenofovir at Week 4|AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng*h/mL||Full Range|Geometric Mean
161529|NCT00272779|Primary|Cmin of Tenofovir at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
161530|NCT00272779|Primary|Cmax of Tenofovir at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
161531|NCT00272779|Primary|Cmin of RTV at Week 4|Cmin was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
161532|NCT00272779|Primary|AUC (0-24) of RTV at Week 4|AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng*h/mL||Full Range|Geometric Mean
161533|NCT00272779|Primary|Cmax of RTV at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
161534|NCT00272779|Primary|Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4|IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
161535|NCT00272779|Primary|Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4|EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
161536|NCT00272779|Primary|Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|T-half was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||Hr||Standard Deviation|Mean
161537|NCT00272779|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Tmax was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||Hr||Full Range|Median
161538|NCT00272779|Primary|Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|Cmin was derived from the plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng/mL||Full Range|Geometric Mean
161539|NCT00272779|Primary|Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4|AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.|All participants who completed the intensive PK study.||ng*h/mL||Full Range|Geometric Mean
161540|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161541|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161542|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161543|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 – 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161544|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96|Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161545|NCT00272779|Secondary|Mean Changes in Fasting Insulin at Week 96|Mean change from baseline in fasting insulin at Week 96.|Baseline (Day 1) and Week 96.|Safety analyses of the treatment period are based on treated population with values for this parameter.||µU/mL||Standard Error|Mean
161546|NCT00272779|Secondary|Mean Changes in Fasting Glucose at Week 96|Mean change from baseline in fasting glucose at Week 96 was determined.|Baseline (Day 1) and Week 96|Safety analyses of the treatment period are based on treated population with values for this parameter.||mg/dL||Standard Error|Mean
161547|NCT00272779|Primary|Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4|Cmax was derived from plasma concentration versus time data.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.|All participants who completed the intensive pharmacokinetic (PK) study.||nanogram(ng)/mL||Full Range|Geometric Mean
161548|NCT00272779|Secondary|Mean Changes in Fasting Lipids at Week 96|Mean change from baseline in fasting lipids at Week 96 was determined.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.|Safety analyses of the treatment period are based on treated population.||mg/dL||Standard Error|Mean
161549|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From Day 1 through Week 96|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161550|NCT00272779|Secondary|Mean Change From Baseline in CD4 Cell Count at Week 96|Mean change from baseline in CD4 count among treated participants was determined.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter.||cells/mm^3||Standard Error|Mean
161551|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline at Week 96|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter. log10 HIV RNA changes from baseline were summarized at Week 96 using observed values.||c/mL||Standard Error|Mean
161563|NCT00272779|Secondary|Mean Change in Body Mass Index (BMI) in Participants at Week 48|Mean change in BMI from baseline at Week 48 was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.||kg/m^2||Standard Error|Mean
161552|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL) at Week 96|HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.||Participants|||Number
161553|NCT00272779|Secondary|Number of Participants With HIV RNA < 50 c/mL) at Week 96|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.|Baseline (Day 1) and Week 96|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.||Participants|||Number
161554|NCT00272779|Secondary|Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Week 48|The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161555|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|Baseline (Day 1) and Week 24|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.||Units on a scale||Standard Error|Mean
161556|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 12.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
161557|NCT00272779|Secondary|Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)|The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.|IBS-QoL is administered at baseline (Day 1) and Week 4.|As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
161558|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48|MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 48|Participants analyzed are as-treated participants with evaluable baseline MOS-HIV. The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
161559|NCT00272779|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24|Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.|Baseline (Day 1) and Week 24.|As-treated participants with evaluable baseline MOS-HIV . The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.||Units on Scale||Standard Error|Mean
161560|NCT00272779|Secondary|Mean Change in Fasting Insulin at Week 48|Mean change from baseline in fasting insulin at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.||micro units (µU)/mL||Standard Error|Mean
161561|NCT00272779|Secondary|Mean Change in Fasting Glucose at Week 48|Mean change from baseline in fasting glucose at Week 48.|Baseline (Day 1) and Week 48.|Safety analyses of the treatment period are based on treated population with values for this parameter.||mg/dL||Standard Error|Mean
161564|NCT00272779|Secondary|Mean Change in Weight From Baseline at Week 48|Mean change in body weight from baseline was determined.|Baseline (Day 1) and Week 48|Safety analyses of the treatment period are based on treated population, who had values for this parameter.||kg||Standard Error|Mean
161565|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161566|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48|Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161567|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48|Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161568|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48|Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161569|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48|Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.|At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161570|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48|Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161571|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48|Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 – 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161572|NCT00272779|Secondary|Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)|Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.|At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.|Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161590|NCT00272168|Secondary|Psychiatric Symptoms|Psychiatric Symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS), a widely used instrument for assessing the positive, negative, and affective symptoms of individuals who have mental illnesses. The BPRS consists of 20 symptom constructs scored from 1 (not present) to 7 (extremely severe). BPRS total score could range from 0 (not present) to 140 (extremely severe).|Post-Treatment|||scores on a scale||Standard Deviation|Mean
161573|NCT00272779|Secondary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48|AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.|From baseline (Day 1) to Week 48.|Safety analyses of the treatment period are based on treated population.||Participants|||Number
161574|NCT00272779|Secondary|Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48|Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change|Baseline (Day 1) and Week 48|Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||Participants|||Number
161575|NCT00272779|Secondary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|Mean change from baseline in CD4 cell counts was determined.|Baseline (Day 1) and Week 48.|All treated participants with data for this parameter.||c/mm^3||Standard Error|Mean
161576|NCT00272779|Secondary|Reduction of log10 HIV RNA Levels From Baseline to Week 48|Changes from baseline in log10 HIV RNA levels were calculated.|Baseline (Day 1) and Week 48|All treated participants with data for this parameter.||c/mL||Standard Error|Mean
161577|NCT00272779|Secondary|Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)|TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population.||Participants|||Number
161578|NCT00272779|Secondary|Number of Participants With HIV RNA < 400 c/mL at Week 48|HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under Non-completers.||Participants|||Number
161579|NCT00272779|Primary|Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48|HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.|Baseline (Day 1) and Week 48|Intent-to-treat (ITT) analysis. Participants received treatment assignment from the central randomization center. In this analysis, participants who did not complete the study were counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under non-completers.||Participants|||Number
161580|NCT00272337|Secondary|Chagne in Endothelial Function From Baseline to 3 Months||Baseline to 3 Months (90-97 days)||||||
161581|NCT00272337|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months.|Heme oxygenase a downstream target of nitric oxide formation|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data||ng/mL||Standard Deviation|Mean
161582|NCT00272337|Primary|Change in Platelet Biomarkers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)||||||
161583|NCT00272337|Primary|Change in Inflammatory Markers From Baseline to 3 Months.||Baseline to 3 Months (90-97 days)||||||
161584|NCT00272311|Primary|Change in Nitric Oxide Formation From Baseline to 3 Months|Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.|Baseline to 3 Months (90-97 days)|Complete baseline and follow-up data||ng/mL||Standard Deviation|Mean
161585|NCT00272311|Primary|Change in Platelet Biomarkers From Baseline to 3 Months||Baseline to 3 Months (90-97 days)||||||
161586|NCT00272311|Primary|Change in Inflammatory Markers From Baseline to 3 Months||Baseline to 3 Months (90-97 days)||||||
161587|NCT00272168|Primary|Employment Status|Data collected included from participants: weekly wages earned|Post Treatment (approximately 3 months after completion of the baseline assessment)|||dollars/week||Standard Deviation|Mean
161588|NCT00272168|Primary|Social Functioning|"This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score.~Very Poor~Poor~Neither good nor poor~Somewhat good~Very good"|Post Treatment|||units on a scale||Standard Deviation|Mean
161589|NCT00272168|Primary|Work Performance (Work Behavior Inventory)|"This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5:~Consistently an area Needing Improvement~Occasionally an area Needing Improvement~Performance Adequate in this area~Occasionally an area of Superior Performance~Consistently an area of Superior Performance.~The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study."|Post Treatment|||rating on a scale||Standard Deviation|Mean
161799|NCT00268437|Secondary|Overall Survival|Time from registration to death due to any cause.|From baseline to 4 years|||months||95% Confidence Interval|Median
161591|NCT00272168|Secondary|Cognitive Insight|"Cognitive insight was assessed using the Beck Cognitive Insight Scale, a 15-item questionnaire developed to evaluate patients' self-reflectiveness and their overconfidence in their interpretations of their experiences. Participant responses to each of these items were as follows:~Do not agree at all~Agree slightly~Agree a lot~Agree completely~Total score for the self-certainty scale could range from 6 to 24. Total score for the self-reflectiveness scale could range from 9 to 36. Total score for the composite score was calculated by subtracting the summed score for the self-certainty scale from the summed score of the self-reflectiveness scale and could range from 3 to 12, lower composite scores are an indicator of lower psychiatric functioning."|Post Treatment|||units on a scale||Standard Deviation|Mean
161592|NCT00272168|Primary|Employment Status|Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.|Post Treatment (approximately 3 months after completion of the baseline assessment)|||Hours worked per week||Standard Deviation|Mean
161593|NCT00272038|Secondary|Toxicity||during study||||||
161594|NCT00272038|Secondary|Overall Survival|One year survival rate.|during study|||percentage of partcipants|||Number
161595|NCT00272038|Secondary|Time to Disease Progression (TTP)|Progression is defined using response evaluation criteria in solid tumors criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a meausrable increase in a non-target lesion, or the appearance of new lesions or the appearance of two new bone lesions.|five years|||months||Full Range|Mean
161596|NCT00272038|Primary|Overall Clinical Benefit of Tarceva in CRPC.|Overall Clinical Benefit= percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0).|5 years|||percentage of pts w/clinical benefit|||Number
161597|NCT00271947|Primary|Number of Participants With Remission or Clinical Improvement as Assessed by Crohn's Disease Activity Index (CDAI) Scores|Clinical remission defined as a CDAI less than 150 and clinical improvement defined as decline in CDI> or = 70 one year following entry. The participant was not assessed according to the criteria of the outcome measure, because the participant was lost for follow-up.|baseline||||||
161598|NCT00271856|Primary|Change in Depression as Measured by the Patient Health Questionnaire-9 (PHQ-9)|We used the Patient Health Questionnaire (PHQ-9) as a measure of depressive symptom severity. The PHQ-9 is the depression module of the self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument. Participants rate the frequency of 9 depression symptoms over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores reflecting greater severity of depressive symptoms.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
161599|NCT00271856|Primary|Change in Positive and Negative Affect Scale (PANAS) Negative Affect (NA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS\). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Negative Affect (NA) score is derived from summing the scores on the 10 negative emotions. Scores on the NA subscale range from 0-40, with higher scores reflecting more negative affect over the past week.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
161600|NCT00271856|Primary|Change in Positive and Negative Affect (PANAS) Positive Affect (PA) Score|Emotion was assessed with the Positive and Negative Affect Schedule (PANAS). The PANAS measures intensity of positive and negative emotions over the past week. The scale consists of 20 items--10 positive and 10 negative emotions. Respondents are asked to indicate how strongly they felt each emotion on a scale from 0 to 4 (not at all to extremely). The Positive Affect (PA) score is derived from summing the scores on the 10 positive emotions. Scores on the PA subscale range from 0-40, with higher scores reflecting more positive affect over the past week.|baseline to 12 months|ITT analyses||scores on the scale||95% Confidence Interval|Mean
161601|NCT00271856|Primary|Change in Perceived Stress as Measured by Perceived Stress Scale (PSS)|Perception of stress was measured with the 10-item version of the Perceived Stress Scale. This widely used measure of perceived stress was designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate how often they felt or thought a certain way over the past month on a 4-point scale (0 = Never, 4 = Very Often). Scores range from 0-40, with higher scores reflecting greater perceived stress.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
161602|NCT00271856|Primary|Change in Depression as Measured by Beck Depression Inventory (BDI)|The BDI is a widely used outcome measure for studies of depression. The BDI consists of 21 items that are rated on a 4-point scale according to how severely they are experienced. Scores range from 0-63, with higher scores reflecting greater depression.|baseline to 12 months|ITT analyses.||scores on the scale||95% Confidence Interval|Mean
161603|NCT00271856|Primary|Change in CD4 T-cell Count||baseline to 12 months|Intent to treat (ITT) analyses. Multiple imputation method used for those who started antiretroviral therapy (ART) between 0 and 12 months.||cells/µl||95% Confidence Interval|Mean
161604|NCT00271856|Secondary|Quality of Life (Short Form Health Survey; SF-36); Cortisol (Basal a.m. and Diurnal Change); T-cell Activation (i.e. CD38-cell Surface Marker) and NK Cell Number and Function; Autonomic Nervous System Activity ; Cell Aging||3, 6, and 12 months||||||
161605|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
161637|NCT00271544|Secondary|Electrical Performance - Tip Electrode: LV Voltage Threshold|Model 4196 lead tip electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.||Volts||Standard Deviation|Mean
171563|NCT00113425|Primary|Change From Baseline in Papule Acne Lesions at Week 10||Baseline and Week 10|||papule acne lesions||95% Confidence Interval|Mean
161606|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
161607|NCT00271817|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
161608|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
161609|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Deviation|Median
161610|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline|Baseline and 64 weeks|The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24.||Percent change||Standard Error|Mean
161611|NCT00271817|Secondary|Percent Change From Baseline in Triglycerides (TG)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline|baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Deviation|Median
161612|NCT00271817|Secondary|Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
161613|NCT00271817|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline|Baseline and 24 weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
161614|NCT00271817|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline|Baseline and 24 Weeks|The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.||Percent change||Standard Error|Mean
161615|NCT00271739|Primary|Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol||5 years|||mg/dL||Standard Error|Mean
161616|NCT00271739|Primary|Blood Pressure Levels||5 years|||mmHg||Standard Error|Mean
161617|NCT00271739|Primary|Hemoglobin A1c Levels||5 years|||A1c percentage||Standard Error|Mean
161618|NCT00271609|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years|||Participants|||Number
161619|NCT00271609|Primary|Percentage of Participants With Progression Free Survival at 6 Months.|Percentage of participants surviving without progression of disease after six months of study entry. Progression is defined as a 25% increase in lesions, clear worsening of any evaluable disease, or appearance of any new lesion/site (e.g. by computed tomography, magnetic resonance imaging), or failure to return for evaluation due to death or deteriorating condition.|6 months|at the time of data cutoff for this endpoint, 31 patients in the AG arm and 48 patients in the GBM arm were evaluable for PFS.||Percentage of participants||95% Confidence Interval|Number
161638|NCT00271544|Secondary|Electrical Performance - Tip Electrode: Sensing|Model 4196 lead tip electrode R-wave amplitude|12-month|Subjects with Model 4196 lead implanted and an intrinsic R-wave available at 12-month visit.||millivolt (mV)||Standard Deviation|Mean
161639|NCT00271544|Secondary|Assessment of Lead Handling Characteristics|"Lead handling characteristics assessed as acceptable by physicians"|Implant|All available assessments from physicians.||participants|||Number
173474|NCT00096265|Secondary|Change in Steroid Dependence|Compared between two treatment arms using a two-group chi-squared test.|From randomization to six months.||||||
161620|NCT00271596|Secondary|Subgroup Analysis of the Hamilton Depression Rating Scale Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.||units on a scale||Standard Error|Least Squares Mean
161621|NCT00271596|Secondary|Total Functional Capacity Score Comparing Baseline (Week -4) to Visits 4 (Week 6) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Total Functional Capacity (TFC) subscale from the Unified Huntington’s Disease Rating Scale (UHDRS). Definition: The TFC is a score that classifies five stages of Huntington's Disease and five levels of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care. Construct Measured: Activities of Daily Living. Scale Range: The TFC score ranges from 0 to 13, where lower scores indicate poorer performance in activities of daily living. Change Calculation Details: Compares change in TFC performance from Baseline (week -4) to the weighted average of visits 4 (week 6) and 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing baseline (week -4) to the weighted average of Visits 4 (week 6) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161622|NCT00271596|Secondary|Hamilton Rating Scale for Depression Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: Compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model comparing screening (intake visit) to Visit 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161623|NCT00271596|Secondary|Trails B Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Trail Making Test Part B (TMT-B). Definition: The TMT-B test requires participants to “connect-the-dots” of 25 consecutive targets on a sheet of paper where the subject alternates between numbers and letters, going in both numerical and alphabetical order. Constructs Measured: Attention, set shifting, and processing speed. Scale range: The TMT-B score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161624|NCT00271596|Secondary|Stroop Interference Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|"Full Scale Name: Stroop Interference subtest from The Stroop Color and Word Test. Definition: Participants are asked to name the ink color in which a word is printed when the word itself (which is irrelevant to the task) is the name of a different color rather than the same color. For example, participants may be asked to say red to the word blue printed in red ink. Constructs Measured: Selective attention, response inhibition, cognitive flexibility, and processing speed. Scale Range: The Stroop Interference score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort."|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161625|NCT00271596|Secondary|Verbal Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Verbal Fluency Score (VFC). Definition: The VFC is the number of words a person can produce given a letter, including (1) Naming words that start with F, A, and S; (2) naming words that start with K, W, and R; (3) naming words that start with V, I, and P; (4) naming words that start with O, G, and B; (5) naming words that start with E, N, and T; and (6) naming words that start with J, C, and S. Construct Measured: Verbal initiation and flexibility. Scale Range: The Verbal Fluency Composite Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in verbal initiation and flexibility from visit 2 (week 0) where patients named words starting with O, G, and B to the weighted average of visits 5 (week 12) and 6 (week 15) where patients named words starting with E, N, and T, and J, C, and S respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161640|NCT00271544|Secondary|Total Implant Time|Total implant time was defined as time from initial incision to final closure.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
161641|NCT00271544|Secondary|Model 4196 Lead Placement Time|Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.|Implant|Subjects successfully implanted with a Model 4196 lead.||minutes||Standard Deviation|Mean
161626|NCT00271596|Secondary|Symbol-Digit Modalities Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: The Symbol Digit Modalities Test (SDMT). Definition: The SDMT screens for organic cerebral dysfunction by having the examinee use a reference key to pair specific numbers with given geometric figures in 90 seconds. Construct Measured: Attention, processing speed, and working memory. SDMT Scale Range: Raw scores may range from 0 to 110, where lower scores indicate poorer performance. Change Calculation Details: Compares change in performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161627|NCT00271596|Secondary|Semantic Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Semantic Fluency Score. Definition: The Semantic Fluency Score is the number of words a person can produce given a category, including naming (1) Animal names, (2) Fruit names, (3) Boy names, (4) Girl names, and (5) Vegetable names. Construct Measured: Working memory and verbal initiation. Scale Range: The Semantic Fluency Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on working memory tasks. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) where patients named fruit names to the weighted average of visits 5 (week 12) & 6 (week 15) where patients named girl names and vegetable names respectively for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161628|NCT00271596|Secondary|Letter Number Sequencing Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort|Full Scale Name: Letter Number Sequencing (LNS) subtest from the Wechsler Adult Intelligence Scale (WAIS) third edition. Definition: LNS is a task that requires the reordering of an initially unordered set of letters and numbers. Construct Measured: Working memory. LNS Score Range: Raw scores may range from 0 to 21, where lower scores indicate poorer performance in working memory. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161629|NCT00271596|Primary|Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort.|Full Scale Name: The Executive Composite Score (ECS). Definition: Subscales were averaged to compute this composite total score. The ECS is the weighted average of performance on 6 subtests of executive function, including (1) the Controlled Oral Word Association Test, (2) Symbol Digit Modalities test; (3) Stroop Color Word Test (Interference Trial), (4) Trail Making test (Part B), (5) Letter-Number Sequencing, and (6) Animal Naming. Construct Measured: Thinking tasks involving planning, working memory, attention, problem solving, verbal reasoning, inhibition, mental flexibility, and task switching. ECS Scale Range: The ECS score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on executive functioning tasks. Change Calculation Details: Compares change in executive functioning performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.|after 15 weeks of treatment|Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort||units on a scale||Standard Error|Least Squares Mean
161630|NCT00271570|Primary|Area Under the Curve of Infliximab Concentration Before Infliximab Infusion and Then 2 and 24 Hours, 1 Week (5 to 9 Days), 2 Weeks (12 to 16 Days), and 4 Weeks (26 to 30 Days) After Infliximab Infusion)|The area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last) was estimated using the trapezoidal rule up to the last measurable concentration.Samples were collected before infliximab infusion and then at 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. Subjects with detectable infliximab concentrations at week 4 had another sample drawn at week 10 (68 to 72 days).|before infliximab infusion and then 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion.|||micogram*day/ml||Inter-Quartile Range|Median
161631|NCT00271570|Primary|Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)|The safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.|2 weeks|||events|||Number
161632|NCT00271544|Secondary|Summarize All Adverse Events|All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu|Up to 18 months|All subjects enrolled into the 4196 study.||adverse events|||Number
161633|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Pacing Impedance|Model 4196 lead ring electrode pacing impedance|12-Month|Subjects with Model 4196 lead implanted and completed 12-month visit.||Ohms||Standard Deviation|Mean
161634|NCT00271544|Secondary|Electrical Performance - Ring Electrode: LV Voltage Threshold|Model 4196 lead ring electrode LV voltage threshold|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.||Volts||Standard Deviation|Mean
161635|NCT00271544|Secondary|Electrical Performance -Ring Electrode: Sensing|Model 4196 lead ring electrode R-wave amplitude|Implant|Subjects with Model 4196 lead implanted and with intrinsic R-wave amplitude at implant.||mV||Standard Deviation|Mean
161636|NCT00271544|Secondary|Electrical Performance -Tip Electrode: Pacing Impedance|Model 4196 lead tip electrode pacing impedance|12-month|Subjects with Model 4196 lead implanted and 12-month visit completed.||Ohms||Standard Deviation|Mean
161646|NCT00271544|Secondary|Subjects Successfully Implanted After Cannulation|A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects with successful CS cannulation after an incision was made (implant attempt)||participants|||Number
161647|NCT00271544|Primary|Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)|Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|Three Months|Subjects with pacing threshold at ring electrode captured at 0.5 milliseconds (ms) at 3-month visit.||volts||Standard Deviation|Mean
161648|NCT00271544|Primary|Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)|Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])|One Month|Subjects with pacing threshold at tip electrode captured at 0.5 milliseconds (ms) at 1-month visit.||volts||Standard Deviation|Mean
161649|NCT00271544|Secondary|Subjects Successfully Implanted With Model 4196 Lead|A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.|Implant|Subjects who underwent Model 4196 lead implant attempt.||participants|||Number
161650|NCT00271544|Primary|Safety (Subjects Without a Model 4196 Lead Related Complication)|A subject who was free of a Model 4196 lead related complication by one month visit.|One Month|Subjects who underwent a Model 4196 left ventricular (LV) lead implant attempt and completed 1-month visit; or experienced Model 4196 lead related complications by 1-month visit.||participants|||Number
161651|NCT00271375|Secondary|Perceived Social Support|Caregiver Perceived Social Support was assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS) a 19-item scale that taps perceived emotional/informational, tangible, and affectionate support, and positive social interaction based on a 5-point likert scale with (1 = None of the time and 5= All of the time) with total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161652|NCT00271375|Secondary|Personal Mastery|Caregiver Personal Mastery was assessed using the Personal Mastery Scale which afforded a general measure of self-perceived ability to manage stressors and effect change in one's life through a 7-item question based on a 5-point likert scale with (5 = Agree A lot and 1= Disagree A lot) and a total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161653|NCT00271375|Secondary|Caregiver Efficacy|Caregiver Efficacy was assessed using the RIS Eldercare Self Efficacy Scale (RIS) a 10-item inventory addressing family caregiver's perception of their own ability to manage care provision challenges in the areas of relationship with the care recipient, instrumental care provision, and self-soothing (managing the strains of care provision) based on a 5-point likert scale with (1 = Im certain I CANNOT Do This and 5= Im certain I CAN Do This) with a total score range between1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161654|NCT00271375|Secondary|Caregiver Mastery|Caregiver Mastery was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through a 4-item question assessing a sense of doing a good job of care provision based on a 5-point likert scale with (5= Agree A lot and 1= Disagree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 5 to 20 were calculated, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Median
161655|NCT00271375|Secondary|Caregiver Satisfaction|Caregiver Satisfaction was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 6-items based on a 5-point likert scale with (1 = Disagree A lot and 5= Agree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 6 to 30 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161656|NCT00271375|Secondary|Caregiver Burden|Caregiver Burden was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 9-items based on a 5-point likert scale with (1 = Never and 5= Nearly always). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 9 to 45 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161657|NCT00271375|Secondary|Depressive Symptoms|Depression symptoms were assessed using the Center for Epidemiological Studies Depression Scale (CES-D Short Form). The CES-D is a 10 Question Scale with total scores ranging from 0-30. Mean scores were calculated by finding the total sum divided by the total number of participants. Any score equal to or above 10 is considered depressed. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161673|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 4-weeks following quit date (Study week 7). Participants rated side effects experienced by None, Mild, or Severe.|4-Weeks Post Quit Date (Study Week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.||Participants|||Number
163679|NCT00246376|Primary|Non-HDL-C|non-HDL-C (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dl||Standard Error|Mean
161658|NCT00271375|Secondary|Physical Function|Physical function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which is represented by 10 items tapping basic functional abilities of the caregiver (Does their health limit them in the following activities). 10 items were scored on a 3-Point Likert Scale with 1= Limited A lot and 3= Not Limited and total scale range between 1 and 3. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161659|NCT00271375|Secondary|Physical Role Function|Physical Role Function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at how emotional or physical issues interfered with everyday social roles of the caregiver. 4 items were scored on a 5-point Likert scale (1 = All of the time and 5= None of the time) with total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161660|NCT00271375|Secondary|Subjective Health|Subjective Health was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at the how the respondent (caregiver) perceived their own health currently and compared to a year ago. Two items were based on a 5-point Likert scale (1 =Excellent and 5= Poor) with a total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total number of items, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).|Baseline, 6 Month Follow-up, 12 Month Follow-up|||units on a scale||Standard Deviation|Mean
161661|NCT00271375|Primary|"To Evaluate User Satisfaction With and Perceived Utility of the Caring for You, Caring for Me Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program"|This question addresses user satisfaction, in terms of caregiving perceived utility of the education program, as well as their actual use of knowledge and skills gained in their caregiving situation.|18 Months|"User evaluation of the Caring for you, Caring for me education program. Data for participants in the Caring for you, Caring for me education program only and Caring for you, Caring for me education program+ Social Work were combined during data collection. Only 71 participants provided results. No data was collected from control group."||participants|||Number
161662|NCT00271219|Secondary|Mother's Psychosocial Functioning at Delivery as Measured by the Addiction Severity Index Psychosocial Index Score|The Addiction Severity Index is a structured clinical interview that assesses problem severity in 7 areas of functioning: alcohol use, drug use, medical, legal, employment, psychosocial, and psychiatric status. Each area of functioning yields a composite scale score between 0 and 1, with higher scores indicating greater problem severity in that area. Only the psychosocial index was examined in this study.|at delivery|||Score on the scale||95% Confidence Interval|Mean
161663|NCT00271219|Secondary|Mother's Measures of Dose Adequacy and Acceptance Over Time (Measured Weekly by Dose Adequacy Measure)|Pregnant women maintained on an opioid agonist medication may require upward adjustment to their medication during the course of pregnant. The Dose Adequacy Measure represented a recordation of dosing adjustments during the course of the study.|from study entry until discontinuation or delivery (min=29 days, max=239 days)|intra-subject variability in dosing (typically 1 dose) over course of the trial was too small to estimate the parameter of interest with sufficient accuracy||dose increase per trimester|||Number
161664|NCT00271219|Secondary|Mother's HIV Risk Behaviors (Measured Monthly by Risk Behavior Assessment)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of occurrence too low to be estimated with accuracy||percentage of HIV risk behaviors|||Number
161665|NCT00271219|Secondary|Mother's Self-report of Drug Use (Measured Monthly by Time Line Follow Back)||monthly from study entry until discontinuation or delivery (min=29 days, max=239 days)|frequency of use during the course of the study was too low to estimate the parameter with sufficient accuracy||percentage of drug use|||Number
161666|NCT00271219|Primary|Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS|Total amount in mg|Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days)|||mg||95% Confidence Interval|Mean
161667|NCT00271219|Primary|Child's Peak Daily Total NAS Score|NAS was measured with the MOTHER NAS scale, which includes 28 items, 19 of which are used for scoring and medication decisions. Scores can range from 0 to 42, with higher scores indicating more severe withdrawal.|minimum twice daily from birth until NAS no longer measured (min=10 days)|||Score on the scale||95% Confidence Interval|Mean
161668|NCT00271219|Primary|Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS)|Neonatal abstinence syndrome (NAS) characterized by hyperirritability of the central nervous system and dysfunction in the autonomic nervous system, gastrointestinal tract, and respiratory system.11 When left untreated, NAS can result in serious illness (e.g., diarrhea, feeding difficulties, weight loss, and seizures) and death.|From birth until hospital discharge (min=4 days, max=10, depending on site)|||participants|||Number
161669|NCT00271219|Primary|Child's Length of Hospital Stay||delivery until hospital discharge (min=2 days, max=79 days)|||days||95% Confidence Interval|Mean
161670|NCT00271219|Primary|Child's Head Circumference Measurement (Measured at Birth)||birth|||cm||95% Confidence Interval|Mean
161671|NCT00271154|Primary|Percentage of Patients Worsened for Clinical Composite Response|Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.|12 Months|All randomized patients were included using Intent to Treat (ITT).||Percentage of participants worsened|||Number
161672|NCT00271154|Secondary|Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)|The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.|Baseline to 12 months|||milliliters per meters squared||Standard Deviation|Mean
161674|NCT00271024|Secondary|Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date|Participants reporting side effects during the previous week by pill type and sex, 1-week following quit date (Study week 4). Participants rated side effects experienced by None, Mild, or Severe.|1-Week Post Quit Date (Study Week 4)|All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.||Participants|||Number
161675|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|52 Weeks Following Smoking Quit Date (Study week 55)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
161676|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|26 Weeks Following Smoking Quit Date (Study week 29)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
161677|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
161678|NCT00271024|Secondary|Weight Change at End of Treatment (Regardless of Quit Status)|Weight change at 12 weeks post quit date (study week 15) for the whole sample regardless of quit status. All data is Mean(SEM) and represents a positive change unless otherwise noted.|Weight change at 12 weeks post quit date (study week 15) from smoking quit date|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome, regardless of their abstinence status at 12 weeks post quit date (study week 15)||Pounds||Standard Error|Mean
161679|NCT00271024|Primary|7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date|7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
161680|NCT00271024|Primary|Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date|Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|12 Weeks Following Smoking Quit Date (Study week 15)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
161681|NCT00271024|Secondary|Weight Change at End of Treatment (Smoking Abstinent Only)|Weight change in lbs at 12 weeks post smoking quit date (study week 15) for only those reporting continued smoking abstinence at the end of treatment. All data are Mean(SEM) and represent positive change, unless otherwise noted. Smoking abstinent for this measure defined as no smoking even 1 puff of a cigarette since the smoking quit date (study week 3), allowing for a 1-week grace period.|Weight change at 12 weeks post smoking quit date (study week 15)|All participants completing through smoking quit date (study week 3) and who were smoking abstinent at end of treatment (study week 15)||Pounds||Standard Error|Mean
161682|NCT00271024|Primary|Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date|Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.|4 Weeks Following Smoking Quit Date (Study week 7)|All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.||Participants|||Number
161683|NCT00271011|Secondary|Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events|The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution. Since accrual was not completed the proportion of patients experiencing toxicities could not be statistically determined.|||||
161684|NCT00271011|Primary|Percentage of Patients With an Objective Response|The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions.|2 months|The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution.|||||
161685|NCT00270894|Secondary|Overall Survival (OS)|Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.|Measured from day 1 of treatment until time of death, assessed up to 48 months.|||Months||95% Confidence Interval|Median
161686|NCT00270894|Secondary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.|||Months||95% Confidence Interval|Median
161701|NCT00270634|Secondary|To Demonstrate a 5% Improvement in Renal Function as Measured by Iothalamate Glomerular Filtration Rate (GFR)|ANOVAs to test for differences in GFR at Month 6.|Six months|Standard deviation around Iothalamate GFR made results uninterpretable, therefore Nankivell GFR was reported as it was collected a priori.||mL/min||Standard Deviation|Mean
173475|NCT00096265|Secondary|Change in Performance Status|Compared between two treatment arms using a two-group chi-squared test.|From randomization to six months.||||||
161687|NCT00270894|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up.|At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36|Note that the number of participants analyzed changes with the study interval. At Screening n=30, after Epirubicin/Cyclophosphamide n=30, Pre-surgery n=28, Follow-up Month 6 n=28, Follow-up Month 12 n=20, Follow-up Month 24 n=9, and Follow-up Month 36 n=1.||LVEF percent||Standard Deviation|Mean
161688|NCT00270894|Secondary|Clinical Response Prior to Surgery|Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters.|Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.|Clinical response assessment was available for 27 patients at the time of surgery.||Participants|||Number
161689|NCT00270894|Secondary|Pathologic Response|Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters.|At completion of neoadjuvant treatment period, up to 24 weeks.|28 patients went to surgery, so 28 patients were included in the surgery sample. Note that 4 patients in the pathologic complete response (pCR) group had residual ductal carcinoma in situ (DCIS).||Participants|||Number
161690|NCT00270894|Primary|Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities|Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.|Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.|||Events|Participants||Number
161691|NCT00270894|Primary|Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule|Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.|From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)|||percentage of participants|||Number
161692|NCT00270842|Secondary|Fall Self Efficacy|Fall Self Efficacy is operationalized as perceived self efficacy (i.e. self confidence) for avoiding a fall during 10 global, relatively non-hazardous activities of daily living (getting dressed and undressed, for example). Fall self efficacy manifests itself with different degrees of fear of falling, each with a unique associated risk level. The MFES is simple, quick, easy-to-administer scale that assesses a patient’s self-reported ability to perform, without falling, each of 14 common activities of daily living in a Likert scale format. Total scale ranges from 0 to 140, the higher score indicated more confidence in ability to manage a fall.|10 weeks|||units on a scale||Standard Deviation|Mean
161693|NCT00270842|Primary|Gait and Balance Measures|The Berg Balance Scale is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community dwelling and institutionalized older adults. The scale consists of 14 common daily balance tasks. Administration requires only minimal basic equipment and takes approximately 15 minutes. All 14 sub-tests are scored on a 5-point ordinal scale based on the subject’s ability to perform the requested task safely and in a timely manner. Sub-test scores are summed to achieve a total score ranging from 0 to 56 with higher scores indicating better performance.|10 weeks|||units on a scale||Standard Deviation|Mean
161694|NCT00270790|Secondary|Response Rates Based on the Study Regimen|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.||participants|||Number
161695|NCT00270790|Primary|Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine|Blood work (CMP was collected and evaluated for neutropenia, leukopenia and anemia) is taken prior to chemotherapy administration. The toxicity levels were measured using Common Terminology Criteria for Adverse Events (CTCAE 3.0) and monitored based on the dose of Amifostine given.|3 years|21 patients enrolled, however only 16 patients were analyzed due to 5 patients withdrawals.||participants|||Number
161696|NCT00270634|Secondary|A Composite of Biopsy-proven Chronic Rejection Graft Loss, Death, or Lost to Follow up.||Six months|Per Protocol Dataset||Percentage of patients|||Number
161697|NCT00270634|Secondary|Hypertension, Hyperlipidemia, or Hyperglycemia||Six months|Endpoint||Percentage of patients|||Number
161698|NCT00270634|Secondary|Graft Survival||Six months|||Percentage of patients|||Number
161699|NCT00270634|Secondary|Patient Survival||Six months|||Percentage of patients|||Number
161700|NCT00270634|Secondary|The Pharmacokinetic-pharmacodynamic Relationship Between Voclosporin and Calcineurin Inhibition (CNi), or Tacrolimus and Calcineurin Inhibition|"A sparse sampling protocol of whole blood samples obtained on Day 180 at time points immediately prior to drug administration and at 1, 2, and 4 hours post‐dose were utilized.~Standard non‐compartmental analysis (NCA) was performed on whole blood concentration data for voclosporin and its metabolites, tacrolimus, MPA (mycophenolic acid) and MPAG (mycophenolic acid glucuronide). Tmax and Cmax were obtained directly from the concentration‐time profiles without interpolation. AUC(0‐4)[area under the curve] was calculated using log‐linear trapezoidal rule. Cmax, AUC(0‐4), C0 and C2 were summarized using descriptive statistics."|Six months|For subjects participating in the PK/PD portion of the study, a calcineurin sample was drawn prior to drug administration in order to assess baseline calcineurin levels. Blood samples were taken at Month 6 for the assessment of pharmacokinetics and pharmacodynamics. Participation by subjects was optional.||% Calcineurin (CNi) compared to baseline||Standard Deviation|Mean
161703|NCT00270257|Secondary|Incident Hepatitis B Infections|Serum samples were tested at baseline and between 26-52 weeks later for Hepatitis B surface antigen (HBsAg) using a commercial enzyme immunoassay (EIA) (Abbott Murex HBsAg version 3.0). If the HBsAg test was initially non-reactive, then the participant was considered to be negative for HBsAg. If the HBsAg test was initially reactive, then it was repeated in duplicate. If at least two of 3 tests were reactive, then the participant was considered to be positive for HBsAg.|Measured through week 52|||participants with HBsAg|||Number
161704|NCT00270257|Secondary|Incident Hepatitis C Infections for Thailand and China|"HCV antibody using two different HCV EIA assays (Ortho HCV antibody version 3.0 and Wantai HCV antibody assay) at baseline and between 26-156 weeks later.~If both HCV EIA antibody assays were nonreactive, then the participant was considered not to be HCV infected. If either assay was reactive, then the Ortho HCV assay was repeated in duplicate. If two of 3 Ortho HCV assays were reactive, then the participant was considered to be HCV infected. Samples that were repeatedly reactive for HCV antibody at a follow-up visit were tested for HCV RNA by the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV assay. Not all participants had follow-up testing performed in China due to early closure of the study by the Data Safety Monitoring Board on account of futility due to a low HIV incidence (the primary study endpoint).~Analysis was done separately for both countries"|Measured through week 156 in Thailand and 104 weeks in China|Baseline HCV antibody negative participants.||participants with HCV antibody|||Number
161705|NCT00270257|Secondary|Self-reported Number of Injections in the Last Month||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.||injections||Inter-Quartile Range|Median
161706|NCT00270257|Secondary|Number of Participants Reported Using Injection Equipment (Needles, Syringes, Cookers, Cottons, and Rinse Water) in the Prior 6 Months||Measured through Week 104|Number of participants presented here applies to whom data available at week 104.||participants|||Number
161707|NCT00270257|Secondary|Self-report of Continued Injection Opiate Use in the Last 30 Days|All participants completed interviewer-administered assessments of injection and non-injection drug use at baseline and at semi-annual visits.|Measured through Week 104|Number of participants presented here applies to whom data available at week 104.||participants|||Number
161708|NCT00270257|Secondary|Number of Participants With Urinalysis Results Positive for Opiates|Urine drug screen were assessed monthly and semiannually.|Measured through Week 104|Number of participants presented here applies to visit 104 for whom data available.||participants|||Number
161709|NCT00270257|Primary|Evidence of HIV-1 Infection or Death for Visits up to 104 Weeks|The primary endpoint for the study was cumulative HIV infection or death after a second year of follow-up (i.e. at week 104), one year after completion of the treatment phase, designed to test a durable intervention effect.|For visits up to week 104|Data Safety Monitoring Board (DSMB) halted the study on October 4, 2011 due to futility as a result of lower than anticipated HIV incidence rates. See participant flow section for the number of participants who completed visit up to 104 by July 31, 2012.||participants|||Number
161710|NCT00270231|Primary|Number of Nicotine Cigarette Choices Taken During the Cigarette Choice Procedure.|"On day 4 of each study medication period, participants completed a cigarette choice procedure where the subject is asked to take 4 puffs from a nicotinized (nicotine-containing) or a denicotinized (no nicotine) cigarette every 30 minutes for 2 hours (maximum of 24 puffs). The outcome variable is the number of nicotine cigarette choices or puffs out of 24 total puffs during these cigarette choice procedures.~Subjects who had the A/A genotype took an average of 18.5 puffs from the nicotine-containing cigarettes. Subjects with the A/G or G/G genotypes took an average of 16.2 puffs from the nicotine-containing cigarettes."|2 hours|Participants were analyzed with respect to genotype regardless of intervention.||Number of Nicotine Cigarette Puffs Taken||Standard Deviation|Mean
161711|NCT00270205|Secondary|Breadth of HIV-1-specific Immune Response, as Determined by the Number of Overlapping HIV-1 Peptides for Which the ELISPOT Assay for IFN-gamma Production is Observed to Have Five or More Spot-forming Cells/ 10^5 PBMCs|Results for this outcome will never be posted. Additional endpoint for supportive exploratory analysis, if ever the necessary assay is performed, will be defined in more detail in a separate analysis plan.|Throughout study||||||
161712|NCT00270205|Secondary|Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens|Results for this outcome will never be posted. There is no plan to run the assay for this outcome measure.|Throughout study||||||
161713|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
161714|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161715|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
161794|NCT00268463|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy Trial Outcome Index at Baseline, at 4-6 Weeks Following Surgery (Before Initiation of Chemotherapy), and Periodically During Study||Prior to randomization, 4-6 weeks after surgery, 18 weeks after the start of chemotherapy and after completion of chemotherapy||||||
161716|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161717|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
161718|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161719|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
161720|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161721|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||percent||Inter-Quartile Range|Median
161722|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||percent||Inter-Quartile Range|Median
161723|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161724|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161725|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
161726|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
161727|NCT00270205|Secondary|Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||percent||Inter-Quartile Range|Median
161728|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to anti-CD3 antigen were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161729|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to whole HIV-1 antigen were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161730|NCT00270205|Secondary|Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev|Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 24|Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.||cells/mm3||Inter-Quartile Range|Median
161731|NCT00270205|Secondary|Anti-dsDNA Antibody Response|Results report the number of participants who had negative anti-dsDNA antibody result at baseline and at week 17 or 61.|From start of study vaccination to week 61|All participants who started study vaccination and who have anti-ds DNA results at baseline and week 17 or 61 were included in the analysis.||participants|||Number
161732|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
161733|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs across gag p17, gag p24, gag 15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
161734|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen as detected by the PHPC assay. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
161735|NCT00270205|Secondary|Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.|At each week, the mean spot-forming cells/10^6 PBMCs detected by the PHPC (precursors with high proliferative capacity) assay across gag p17, gag p24, gag p15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.|From start of study vaccination to week 37|Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.||spot-forming cells/10^6 PBMC||Inter-Quartile Range|Median
161736|NCT00270205|Secondary|Time-averaged AUC of CD8+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD8+ T-cell count responses was used to characterize each participant's overall CD8+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD8+ T-cell count responses at all study visits were included in the analysis.||cells/mm^3||Inter-Quartile Range|Median
161753|NCT00269633|Primary|Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD); Weekly for Three Weeks|Outcome for Structured Interview Guide for the Hamilton Depression Scale - Seasonal Affective Disorder Version (SIGH-SAD) reported is the average over 3 weeks. Lower values represent less depressive symptoms. Range is 0-53.|Averaged over Three Weeks During Treatment|||units on a scale||Standard Deviation|Mean
161737|NCT00270205|Secondary|Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs|Area under the curve (AUC) using linear trapezoidal method, of CD4+ T-cell count responses was used to characterize each participant's overall CD4+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.|From start of study vaccination to week 61|Only those participants who started study vaccination and who have complete and non-missing CD4+ T-cell count responses at all study visits were included in the analysis.||cells/mm3||Inter-Quartile Range|Median
161738|NCT00270205|Primary|Percent of Participants With Primary Safety Endpoint|Primary safety endpoint is defined as occurrence of at least one grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment. Event's relationship to the study treatment was determined by the protocol core team, including site clinicians on the team, blinded to the treatment arm. Adverse events solely attributed to an allergic reaction to the adhesive of the tape used to adhere the vaccination patch to the skin and not the vaccine itself were not used in determination of the primary safety endpoint.|From start of study vaccination to 28 days after the last study vaccination|Only those participants who started study treatment/vaccination were included in the analysis.||percentage of participants||95% Confidence Interval|Number
161739|NCT00269919|Secondary|Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of risperidone long acting injection (RLAI). Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.||Units on a scale||Standard Deviation|Mean
161740|NCT00269919|Secondary|Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of medication and 2) attitudes and beliefs toward neuroleptics which may influence medication compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score for each person at each time is the positive score minus the negative score.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
161741|NCT00269919|Secondary|Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score|"The LUNSERS is a self-report measure of antipsychotic side effects. It consists of 51 questions, 41 questions on side effects and 10 questions are of red herrings to validate the results. Each question is rated on a 4-point scale, where 0=not at all; and 4=very much. The total neuroleptic side effect score is the sum of the scores for the side effects items (i.e. all items excluding the red herrings). Total side effects score ranges from 0 to 164, where 0 to 40=low side effect rating, 41 to 80=medium side effect rating and greater than 81=high side effect rating."|Baseline and Week 96|The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of RLAI. Here, ‘N'=the participants who were evaluated for this outcome measure and ‘n'=the participants who were evaluated for this outcome measure at given time point.||Unit on a scale||Standard Deviation|Mean
161742|NCT00269919|Secondary|Change From Baseline in NCFT: TMT-Error at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the the number of errors.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."||Errors||Standard Deviation|Mean
161743|NCT00269919|Secondary|Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96|TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the response time.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."||Seconds||Standard Deviation|Mean
161744|NCT00269919|Secondary|Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96|MQ was obtained by adding up the results of verbal memory and visual memory test. The memory quotient will include learning curve, memory retention, retrieval efficiency, drawing/memory consistency, verbal/visual memory consistency and intelligence/memory consistency. The highest MQ is 160, which indicates excellent memory.|Baseline and Week 96|"The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, N is the number of participants evaluated for this outcome measure."||MQ||Standard Deviation|Mean
161752|NCT00269919|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96|The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.|Baseline and Week 96|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 efficacy measurement post-baseline. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
161745|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96|The RCFT is a neuropsychological assessment designed to evaluate visual memory in participants. The RCFT is useful in evaluating the spatial perception and visual memory. The RCFT consists of 3 test conditions: Copy, Immediate Recall and Delayed Recall. At the first step, participants are given the RCFT stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered. Then, after a delay of 30 min, they are required to draw the same figure once again, a score of 2 points for each drawn element (a complete straight line or a circle) remembered correctly. The total score is the sum of points scored for each correctly drawn element and it ranges from 0 to 36. The maximum score indicates excellent visual memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.||Units on a scale||Standard Deviation|Mean
161746|NCT00269919|Secondary|Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96|The KAVLT is a neuropsychological assessment designed to evaluate verbal memory in participants. The KAVLT is useful in evaluating the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the participants hears a list of 15 words, and are asked to recall as many words from the list as possible. This procedure is carried out a total of 5 times. Then a second list of 15 words is presented, allowing the participants only 1 attempt to recall. Immediately following this, the participants are asked to remember as many words as possible from the first list. KAVLT consists of 2 test conditions: Delayed Recall and Delayed Recognition. The upper limit for ‘words recalled’ is 15, which represents better episodic memory.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.||Words recalled||Standard Deviation|Mean
161747|NCT00269919|Secondary|Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96|The Controlled Oral Word Associated Test is a measure of verbal fluency, which requires participants to generate words orally that begin with a given letter of the alphabet. Participants are given 1 min to name as many words as possible. Performance was calculated by the number of words generated in the 1-min period. This measure, requiring rapid and organized word retrieval, is a sensitive indicator of brain dysfunction.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure.||Words generated per min||Standard Deviation|Mean
161748|NCT00269919|Secondary|Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96|The K-WAIS is a Korean version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R). It is an intelligence test that assess 3 general areas of intelligence quotients (IQ): verbal IQ, performance IQ and full-scale IQ (FSIQ). The verbal IQ includes: Digit Span, Vocabulary, and Arithmetic; performance IQ includes: Picture Arrangement and Block Design; and FSIQ is an IQ assessed by measuring an individual's overall level of general cognitive and intellectual functioning. The highest FSIQ is 160. The greater the quotient, higher the level of intelligence.|Baseline and Week 96|The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here ‘N'=participants who were evaluated for this outcome measure and ‘n'=participants who were evaluated for this outcome measure at given time point.||Intelligence quotient (IQ)||Standard Deviation|Mean
161749|NCT00269919|Secondary|Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96|The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
161750|NCT00269919|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96|GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. Lower scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
161751|NCT00269919|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96|The CGI-S rating scale is used to rate the severity of a participant's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and Week 96|The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, ‘N'=the participants who were evaluated for this outcome measure.||Units on a scale||Standard Deviation|Mean
161777|NCT00268983|Secondary|Hematologic Nadir for Hemoglobin|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||Grams per deciliter (G/dL)||Full Range|Median
161754|NCT00269477|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions|Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population||Participants|||Number
161755|NCT00269477|Primary|Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination.~Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination."|28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)|SBA-BR titer for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Participants|||Number
161756|NCT00269152|Secondary|Overall Survival at 6 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|Baseline to date of death from any cause assessed at 6 years|All randomized participants. Intent to treat population.||percent probability of survival (%)||95% Confidence Interval|Number
161757|NCT00269152|Secondary|3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.|length of time disease free, assessed at 3 years|All randomized participants. Intent to Treat population.||probability of disease-free survival (%)||95% Confidence Interval|Number
161758|NCT00269152|Secondary|Overall Survival at 3 Years|For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.|baseline to date of death from any cause, assessed at 3 years|All randomized participants. Intent to treat population.||percent probability of survival (%)||95% Confidence Interval|Number
161759|NCT00269152|Secondary|Grade III/IV Adverse Events|Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.|every 21-day cycle for 4 cycles|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).||participants|||Number
161760|NCT00269152|Primary|The Feasibility of Post-Surgery Chemotherapy|Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.|every 21-day cycle for 4 cycles up to 30 days after last infusion|Number of participants in safety population, that is, number of participants enrolled, randomized and treated with at least one dose of study drug (presented by treatment received arm).||participants|||Number
161761|NCT00269113|Secondary|Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months|Time to next treatment was defined as the interval from randomization date to the time when new treatment was needed. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
161762|NCT00269113|Secondary|Response Duration - Percentage of Participants Event Free at 24 Months|Response duration defined as interval from first assessment of CR/PR to PD. PD is an increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
161763|NCT00269113|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months|DFS was defined as the interval from first assessment of CR to PD. PD is an increase in the frequency and severity of disease symptoms, the occurrence of new nodal or extranodal lymphoma manifestations, the volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
161764|NCT00269113|Secondary|Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months|EFS was defined as the interval from randomization date to therapy failure. Therapy failure was defined after 2 cycles as no change (NC) or progression of disease (PD); after 6 cycles as minimal response [MR], NC, or PD); or death from any cause. NC is defined as tumor regression of <25%, stable disease and progression ≤25%. PD was defined as the increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, and increase of splenomegaly by more than 25%. MR was defined as tumor regression between 50% (<50%) and 25% (≥25%) for at least 4 weeks without occurrence of new manifestations. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
161765|NCT00269113|Secondary|Overall Survival (OS) - Percentage of Participants Alive at 24 Months|OS was defined as interval from randomization to date of death of any cause. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.|Month 24|ITTcbcc/FL Population||percentage of participants|||Number
161778|NCT00268983|Secondary|Hematologic Nadir for Absolute Neutrophil Count|Hematologic toxicity includes the analysis of hematologic nadir, which is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population excluding participants that did not have data within the 120 days of study drug administration.||10^3/cubic millimeter (mm^3)||Full Range|Median
161766|NCT00269113|Secondary|Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months|PFS was defined as the interval from randomization date to progression of disease or death from non-Hodgkin's Lymphoma (NHL). Progression of disease was defined as: increase in the frequency and severity of disease symptoms; occurrence of new nodal or extranodal lymphoma manifestations; volume increase of pre-existing lymphoma manifestations by more than 25%; or increase of splenomegaly by more than 25%. Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha equals (=) 5% for difference between the treatment groups.|24 months|ITTcbcc/FL Population||percentage of participants|||Number
161767|NCT00269113|Primary|Percentage of Participants Achieving CR or PR at the End of Therapy|CR was defined as a complete remission of all objective medical findings at the time of restaging, with complete resolution of pre-existing swelling of the lymph nodes, as well as a pre-existing hepatomegaly and splenomegaly, for at least 4 weeks. This was in exclusion of persistent lymphoma infiltration of the bone marrow by means of bone marrow biopsy; normalization of blood counts with granulocytes greater than (>)1.5 giga particles per liter (Gpt/L) (which is the equivalent of 10^9/L), hemoglobin (Hb) >7.5 millimoles per liter (mmol/L), and platelets less than (<) 100 Gpt/L. PR was defined as greater than or equal to (≥)50 percent (%) reduction of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest perpendicular diameters) for at least 4 weeks without occurrence of new manifestations and normalization of blood counts.|Following completion of 6 cycles (24 weeks)|The ITT centroblastic-centrocytic (cbcc)/Follicular Lymphoma (FL) (collectively, ITTcbcc/FL) population included all participants in the ITT population with cbcc lymphoma (target population).||percentage of participants||95% Confidence Interval|Number
161768|NCT00268983|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a Grade 4 (life threatening or disabling) non-hematologic laboratory abnormality assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|From randomization through Week 26|ITT-Exposed Population||Participants|||Number
161769|NCT00268983|Secondary|Number of Participants With Myelodysplasia/Leukemia|The cumulative incidence of myelodysplasia/leukemia was estimated.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||Participants|||Number
161770|NCT00268983|Secondary|Number of Hospitalizations|The frequency of hospitalizations within 90 days of treatment was summarized. Because too few evaluable participants were enrolled/treated, analysis of the number of hospitalizations was not conducted as planned.|Time of treatment until 90 days post-treatment|ITT-Exposed Population|||||
161771|NCT00268983|Secondary|Number of Participants With an Infusion Reaction|An infusion reaction is defined as any adverse event that occured within 24 hours of an infusion. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|First 24 hours of study drug administration.|ITT-Exposed Population||participants|||Number
161772|NCT00268983|Secondary|Number of Participants That Developed Hypothyroidism|Hypothyroidism is defined as elevated Thyroid-Stimulating Hormone (TSH) or current history of using thyroid medication. The frequency of hypothyroidism at study enrollment will be determined, and participants with hypothyroidism at Baseline were excluded from analysis.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||Participants|||Number
161773|NCT00268983|Secondary|Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters|Duration of Grade 3/4 toxicity is defined as the time between the date of the first Grade 3/4 lab result to the first lab date with a Grade of 0, 1, or 2 result. Laboratory abnormalities will be recorded as AEs using NCI CTCAE, Version 3, if they are associated with clinical squeal and/or require an intervention. Specific AEs not listed in the NCI criteria will be graded as follows: 1. Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities, 2. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities, 3. Severe: An event that prevents normal everyday activities, 4. Life-threatening or debilitating, and 5. Death|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population. Participants with a Grade 3/4 toxicity level for the indicated hematological parameters were analyzed (reflected by n=X, X). Different participants may have been analyzed for different parameters; thus, the overall number analyzed reflects everyone in the ITT-Exposed Population.||Days||Full Range|Median
161774|NCT00268983|Secondary|Time to Recovery to Baseline Grade for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to recovery to Baseline grade is defined as the number of days from the last administration of study drug to a post-nadir hematology value of unmaintained Baseline grade or lower.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||Days||95% Confidence Interval|Median
161775|NCT00268983|Secondary|Time to Nadir Values for the Indicated Hematological Parameters|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to nadir is defined as the number of days from the last administration of study drug to nadir.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||Days||Standard Deviation|Mean
161776|NCT00268983|Secondary|Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count|Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population||10^3/microliter (µL)||Full Range|Median
163680|NCT00246376|Secondary|Body Composition|"Body cell mass (kg)~Fat mass (kg)"|Measured at 24 weeks|The number corresponds to the number of subjects who completed the study (see Participant flow)||kg||Standard Error|Mean
161779|NCT00268983|Secondary|Time to Next Treatment|Time to next treatment is defined as time from the date of randomization until the new treatment is needed for NHL. Because too few evaluable participants were enrolled/treated, analysis of the time to next treatment was not conducted as planned.|Time from study randomization to 120 days after study drug administration|ITT-Exposed Population|||||
161780|NCT00268983|Secondary|Number of Participants Who Had Died by the Month Indicated|The median time to death could not be calculated for participants in either treatment group; thus, data are shown as the number of participants who had died by the month indicated.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||participants|||Number
161781|NCT00268983|Secondary|Time to Death|"Time to death is defined as the time from treatment start to the date of death. As a median time to death is not presented for either group, see the outcome measure entitled Number of Participants Who Had Died by the Month Indicated for data regarding time to death."|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||months||95% Confidence Interval|Median
161782|NCT00268983|Secondary|Duration of Response|Response duration is defined as the time from the first documented response (complete response, complete response unconfirmed, or partial response) until disease progression. Partial response is defined as at least a 50% decrease in the product of two perpendicular diameters of all measurable lesions; no increase in the size of other nodes, liver, or spleen; and no new disease sites.|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population. Only those participants with confirmed or unconfirmed complete response or partial response were analyzed for duration of response.||months||95% Confidence Interval|Median
161783|NCT00268983|Secondary|Number of Participants Achieving Response|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms (by the IWSRC) if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Confirmation of response was carried out by an independent reviewer|Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually|ITT-Exposed Population||Participants|||Number
161784|NCT00268983|Primary|Progression-free Survival|Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|ITT-Exposed Population||months||95% Confidence Interval|Median
161785|NCT00268983|Primary|Event-free Survival (EFS)|Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.|From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)|Intent-to-Treat (ITT)-Exposed Population: all participants who received at least one dose of treatment||Months||95% Confidence Interval|Median
161786|NCT00268905|Secondary|Percent of Subjects With Best Overall Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD).|From start of eribulin treatment until disease progression or death|Efficacy Evaluable Population||percentage of subjects|||Number
161787|NCT00268905|Secondary|Safety of Eribulin Mesylate in Combination With Carboplatin as Measured by the Number of Subjects With Treatment Emergent Adverse Events.|Adverse events were considered treatment emergent if they started on or after the date of administration of the first dose of study drug, or if they were present prior to the administration of the first dose of study drug and increased in severity during the study.|Throughout the entire study|Safety Evaluable Population||participants|||Number
161788|NCT00268905|Primary|Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.|MTD was established by summarizing the number and percent of subject with dose- limiting toxicities (DLTs) for the first cycle.|21 days (first cycle)|||mg/m^2|||Number
161789|NCT00268892|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|4.5 years|||participants|||Number
161790|NCT00268892|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.|Baseline and up to 4.5 years|The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A.||participants|||Number
161791|NCT00268762|Secondary|Arterial Complete Recanalization at 24 Hours Post tPA Bolus|Complete recanalization at 24 hours post tPA bolus as measured by either transcranial Doppler ultrasound or CT-Angiography.|24 hours from tPA bolus|||percent of patients|||Number
161800|NCT00268437|Primary|Pathologic Complete Response Rate|The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.|Baseline to time of surgery (around 10 – 18 weeks post-baseline)|||percentage of participants||95% Confidence Interval|Number
161801|NCT00268346|Primary|The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.|The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.|at 8 weeks after initiation of treatment|All patients enrolled were analyzed||participants|||Number
161802|NCT00268242|Secondary|Percentage of Patients Making it to Bone Marrow Transplant.|Assessing the number of patients who were able to have protocol treatment and have a bone marrow transplant after treatment.|After completion of protocol therapy|||percentage of Patients completed a BMT|||Number
161803|NCT00268242|Primary|Duration of the First Complete Response||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|Only 5 patients had a complete response, therefore on 5 patients were analyzed for this measure.||months||Full Range|Median
161804|NCT00268242|Secondary|White Blood Cell Count at Time of Relapse||After a CR is achieved, patient will be followed at 3 month intervals for disease progression, typically for up to 5 years.|||cells per microliter||Full Range|Median
161805|NCT00268242|Secondary|Laboratory Correlates: Immunohistochemistry|"Percentage of patients who had a moderate-strong (2-3+) expression of multidrug resistance (MDR) genes by immunohistochemistry.~Multidrug resistance gene 1 (MDR1)~Equilibrative nucleoside transporter 2(SLC29A2)"|Baseline|23 of 24 patients had available blocks for Immunohistochemical (IHC) analysis; Participants with the SLC29A2 Gene Expression (n=22)||percentage of participants|||Number
161806|NCT00268242|Secondary|Disease-free and Overall Survival||After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years.|1 patient died on day 1 of protocol therapy (secondary to complications from AML).||participants|||Number
161807|NCT00268242|Primary|Complete Response Rate|Assumptions/ hypothesis: A Complete Response (CR) rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Four weeks is anticipated for observation for response. Only 5 patients (21%) achieved a CR and therefore, the study was terminated. Since response was assessed using the International Working Group criteria, a complete response was determined by Morphologic complete remission: A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL, a cytogenic CR and a morphologic CR with incomplete blood count recovery (CRi).|4 Weeks|A total of 5 patients (21%) achieved a complete response.||participants|||Number
161808|NCT00268203|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal.|From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)|ITT Population. Participants who did not experience treatment failure were censored at the date of their last contact.||Months||95% Confidence Interval|Median
161809|NCT00268203|Primary|Time to Progression or Death|Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD.|From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)|ITT Population. Participants who did not have disease progression or death were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
161810|NCT00268203|Primary|Duration of Response (DOR) in Confirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented CR until PD (up to 161 months)|ITT Population. Only those participants with a confirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
161839|NCT00267670|Primary|The Number of Participants With a 30% Reduction in Alanine Aminotransferase (ALT) Treated With Pentoxifylline (PTX) or Placebo for 12 Months.|The primary goal of the study was to determine whether pentoxifylline (PTX) therapy improved serum ALT (> or = 30% change from baseline to month 12) compared to placebo.|baseline and 12 months|The primary analysis was done as intention to treat. A secondary analysis was performed per protocol and there were no differences between the two analyses. Intention to treat results are reported.||participants|||Number
161811|NCT00268203|Primary|Duration of Response (DOR) in Unconfirmed Complete Responders|DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented unconfirmed CR until PD (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
161812|NCT00268203|Primary|Duration of Response for Participants With Confirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with a confirmed CR or PR were analyzed for duration of confirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
161813|NCT00268203|Primary|Duration of Response for Participants With Unconfirmed Response (CR+PR)|Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From the time of the first documented response (CR or PR) until disease progression (up to 161 months)|ITT Population. Only those participants with an unconfirmed CR or PR were analyzed for duration of unconfirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact.||Months||95% Confidence Interval|Median
161814|NCT00268203|Primary|Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for confirmed response (those with at least one response assessment) were analyzed.||Participants|||Number
161815|NCT00268203|Primary|Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter [SPPD] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma.|From randomization until the first documented complete response or partial response (up to 161 months)|Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for unconfirmed response (those with at least one response assessment) were analyzed.||Participants|||Number
161816|NCT00267969|Secondary|Psoriasis Area and Severity Index (PASI) 75 Responders at Week 52|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 52 in participants randomly assigned to a treatment group at Week 40. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 52|Patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||participants|||Number
161817|NCT00267969|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12|Change from baseline in Dermatology Life Quality Index (DLQI) from baseline at Week 12. This DLQI is a 10-item questionnaire, that in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Baseline (Week 0), Week 12|Patients were included in the analysis according to the assigned treatment groups. Zero change is imputed if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Scores on a scale||Inter-Quartile Range|Median
161840|NCT00267644|Secondary|Minimum IVC Diameter|Minimum Inferior Vena Cava Diameter in mm|10 minutes|||mm||Full Range|Median
161841|NCT00267644|Primary|Maximum IVC Diameter|Maximum Inferior Vena Cava diameter in mm|10 minutes|||mm||Full Range|Median
161818|NCT00267969|Secondary|Number of Participants Who Achieved a Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA is used to determine the participant’s psoriasis lesions overall at a given time point. Overall lesions will be graded as : (0) = cleared, (1) = minimal, (2) = mild, (3) = moderate, (4) = marked, and (5) = severe for induration, erythema, and scaling. The sum of the 3 scales will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|Intent to treat. All patients were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.||participants|||Number
161819|NCT00267969|Primary|Psoriasis Area-and-severity Index (PASI) 75% Improvement From Baseline at Week 12.|The number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]) at Week 12. This is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|Week 12|Intent to treat. All patients randomized were included in the analysis according to the assigned treatment groups. Patient is considered a non- responder if the patient has used any pre-specified prohibited medications or discontinued due to lack of efficacy, or an AE of worsening of psoriasis, or had missing data at Week 12.||Participants|||Number
161820|NCT00267956|Secondary|Change in Dermatology Life Quality Index (DLQI) at Week 12|Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10 item questionnaire, is designed to assess the impact of the disease on a participant’s quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The score ranges from 0 (better quality of life) to 30 (worse quality of life).|Week 0 to Week 12|All participants randomized with baseline ≥ 3% body surface area psoriatic involvement were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Scores on scale||Inter-Quartile Range|Median
161821|NCT00267956|Secondary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12|Number of participants achieving greater than or equal to 75 perccentage mprovement PASI at Week 12. PASI is widely used tool for the measurement of severity of psoriasis. This is a test of how bad person's psoriasis is. The combine redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 12|All participants randomized with baseline ≥ 3% body surface area (BSA) psoriatic involvement and with evaluable measurement are included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.||Participants|||Number
161822|NCT00267956|Secondary|Change in Health Assessment Questionnaire (HAQ) at Week 12|The HAQ is a 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Week 0 to Week 12|Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.||Scores on scale||Inter-Quartile Range|Median
161823|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12|ACR 70 response is an improvement of greater than or equal to 70 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participant randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.||Participants|||Number
161824|NCT00267956|Secondary|Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12|ACR 50 response is an improvement of greater than or equal to 50 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.||Participants|||Number
161825|NCT00267956|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 0 to Week 12|Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.||Participants|||Number
161826|NCT00267774|Secondary|Cost Effectiveness||Index procedure||||||
161827|NCT00267774|Primary|Major Adverse Cardiac Events||1 year|||participants|||Number
161828|NCT00267748|Other Pre-specified|FACT–Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)|"FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy –Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.~The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS."|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Units on scale||Standard Deviation|Mean
161829|NCT00267748|Other Pre-specified|Functional Assessment of Cancer Therapy-General (FACT-G)|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Units on a scale||Standard Deviation|Mean
161830|NCT00267748|Secondary|Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date –start of treatment date + 1)/30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Months||95% Confidence Interval|Median
161831|NCT00267748|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR.||Months||Full Range|Median
161832|NCT00267748|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|ITT population included all participants who were randomized into the study regardless of whether they received study medication.||Percentage of participants||95% Confidence Interval|Number
161833|NCT00267748|Primary|Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model|MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.|From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years|The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.||Months||95% Confidence Interval|Median
161834|NCT00267696|Secondary|Overall Survival for Patients Treated With the Regimen.|The period of time from study entry until disease progression or date of last contact.|To progression of Disease|||months||95% Confidence Interval|Median
161835|NCT00267696|Primary|Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.|Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.|up to 6 months|||months||95% Confidence Interval|Median
161836|NCT00267670|Secondary|Change in Serum Adiponectin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months||one year|||ug/mL||Standard Error|Mean
161837|NCT00267670|Secondary|Change in Serum Leptin Levels in Patients Treated With Pentoxifylline or Placebo for 12 Months|Values represent changes in leptin from baseline to 12 months in patients treated with pentoxifylline or placebo.|baseline and one year|||ng/mL||Standard Error|Mean
161838|NCT00267670|Secondary|The Effect of Pentoxifylline on Change in Tumor Necrosis Factor [TNF]-α Levels in Patients With NASH|The mean change from baseline to month 12 in proinflammatory cytokines (such as TNF-α) and gene expresssion were the secondary endpoints and were analyzed with the same analysis of covariance model and summary statistics specified for the primary endpoint. Differences were regarded as statistically significant when P < 0.05. The results for TNF-α are reported here. Interleukin-6 [IL-6], IL-10) and expression of TNF-alpha Receptors (p55 and p75) had insufficient data for statistical analysis.|one year|Intention to Treat with last observation carried forward||pg/dL||Standard Error|Mean
161843|NCT00267488|Secondary|Safety and Tolerability as Summarized Through Adverse Event Reporting|AE = Adverse Event reported at a frequency of greater than or equal to 16%. SAE = Serious Adverse Events where all were reported at 0% frequency.|Week 0 to week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Number of Events|||Number
161844|NCT00267488|Secondary|Time to Response|The time from start of treatment until the first documented response. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98|||Hours||95% Confidence Interval|Mean
161845|NCT00267488|Secondary|Response Duration|The time from initial documented response to the first documented sign of progression or death due to progressive disease. Not calculated due to no Complete response and only 1 partial response.|Week 0 to week 98|||Weeks||95% Confidence Interval|Mean
161846|NCT00267488|Secondary|Overall Survival|Kaplan-Meier Estimate. Overall survival is defined as time from start of treatment until death due to any cause. Subjects who are alive at the time of analysis will be censored at the time of last contact.|Week 0 to Week 98|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Weeks||95% Confidence Interval|Mean
161847|NCT00267488|Secondary|Time to Progression|Kaplan-Meier Estimate. Time to progression is defined as time from start of treatment until the first documented sign of disease progression or death due to progressive disease. Subjects who have not progressed or died at the time of analysis will be censored at the time of initiation of alternative anti-cancer therapy or time of last contact. Percentiles represent a set of points on a scale arrived at by dividing a group into parts in order of magnitude.|Week 0 to Week 19 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Weeks||95% Confidence Interval|Mean
161848|NCT00267488|Primary|Best Overall Response|Tumor response based on GOG (Gynecological Oncology Group) modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. A 4-point scale used specifying tumor response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions; (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; (PD): At least a 20% increase in the sum of the LD of target lesions|Week 0 to Week 98 when endpoints were met|Intent To Treat (ITT) Population - All subjects who received at least one dose of study medication.||Participants|||Number
161849|NCT00264875|Primary|Mean Visual Analogue Scale (VAS) Pain Scores|"Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.~Endpoint = last non-missing observation carried forward after Baseline visit."|Baseline, Week 4, Week 8, Week 12, and Endpoint|The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.||score on scale||Standard Deviation|Mean
161850|NCT00267293|Primary|Child Temperature (Degrees C)Over 6 Hours|Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.|6 hours|Analysis was ITT per sample size calculation at 80% power.||degrees Celcius||Standard Deviation|Mean
161851|NCT00267202|Secondary|Number of Participants Requiring 0 to >=5 Doses of Rescue Medications for Systemic Allergic Reactions (SARs) to Specific Immunotherapy (SIT)|Epinephrine for injection, antihistamines, corticosteroids for injection, inhaled beta-agonists, and oral corticosteroids, as well as other drugs used for managing acute allergic reactions to SIT, were available during all study visits. One dose of rescue medication for SAR reactions was equivalent to 1 entry of the CRF page 'concomitant medications/significant non-drug therapies associated with immunotherapy' in response to the question 'Was this medication given in response to a SAR?'|Up to 26 Weeks|Efficacy population: Consisted of all randomized participants who completed the omalizumab or placebo treatment period, received at least one dose of immunotherapy and received rescue therapy.||participants|||Number
161852|NCT00267202|Secondary|Number of Participants Requiring 8 to 20 Visits to Complete Cluster Specific Immunotherapy (SIT) Dosing Regimen|During period 3, a cluster dosing protocol was utilized to initiate the allergen immunotherapy (IT). Participants received escalating doses of IT according to a cluster dosing titration regimen. Visits 5 through 13 were cluster visits for this study. The number of visits needed for completion of the cluster SIT dosing regimen was defined as the number of planned visits plus the number of unplanned visits needed to reach maintenance IT dose.|Up to 26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
161853|NCT00267202|Secondary|Number of Participants Who Achieved Target Maintenance Specific Immunotherapy (SIT) Dose|Achievement of target maintenance IT dose is defined as answering 'Yes' to the question, 'Was the target maintenance SIT dose achieved?' on Visit 13, Week 16.|16 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
161854|NCT00267202|Secondary|Severity of First Systemic Allergic Reaction (SAR)|Systemic reactions associated with immunotherapy (IT), defined as occurring within 1 hour following injection of SIT, were graded on a four-point scale: Grade 1: Skin symptoms (generalized urticaria, itching, or erythema), Grade 2: Gastrointestinal symptoms (stomach pain, nausea, or vomiting), Grade 3: Respiratory symptoms (clinically significant nasal symptoms and/or dyspnea, wheezing, persistent cough, etc.), Grade 4: Cardiovascular symptoms (cyanosis, hypotension, collapse, arrhythmias, or angina pectoris).|26 Weeks|Efficacy population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
161855|NCT00267202|Primary|Number of Participants With Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT)|The number of participants with Systemic Allergic Reactions (SAR) to Specific Immunotherapy (SIT). A SAR was captured and recorded as an outcome, not as adverse events (AEs) or SAEs. The primary analysis time point was the end of Period 4 (maintenance immunotherapy). Participants were observed for 1 hour after each immunotherapy (IT) injection visit. Allergic reactions were graded on a 4-point scale from Grade 1 to Grade 4. Grade 1: Skin symptoms, Grade 2: Gastrointestinal symptoms, Grade 3: Respiratory symptoms and Grade 4: Cardiovascular symptoms.|26 Weeks|Efficacy Population: Consisted of all randomized patients who completed the omalizumab or placebo treatment period and received at least one dose of immunotherapy.||participants|||Number
163681|NCT00246376|Secondary|Insulin Sensitivity|Adiponectin (micrograms/ml)|Measured at 24 weeks|All subjects who completed 24 weeks.||micrograms/ml||Standard Error|Mean
161856|NCT00267189|Secondary|Number of Patients With Discontinuation of Study Medication||6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.||Patients|||Number
161857|NCT00267189|Secondary|Percentage of Patients With Efficacy Failure (Biopsy Proven Acute Rejection [BPAR], Graft Loss or Death)|The composite efficacy failure endpoint encompasses at least one of: biopsy proven acute rejection, graft loss, or death for the patient. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy. Acute rejection episodes were recorded as Liver Allograft Rejection. The allograft was presumed to be lost if a patient had a liver retransplant or died.|6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication.||Percentage of patients|||Number
161858|NCT00267189|Primary|Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)|"The primary variable was renal function assessed by calculated creatinine clearance using the Cockcroft-Gault formula, and was assessed at all visits.~CrCl[mL/min] = (140 – A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|From baseline to 6 months|Intention to treat (ITT) population includes all patients who were randomized to one of the treatment groups and received at least one dose of study medication. Patients with baseline and 6 month creatinine clearance were included in analysis. Missing values at 6 months were imputed using the last observation carried forward (LOCF) approach.||mL/min||Standard Deviation|Mean
161859|NCT00267150|Secondary|Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy|Assessed by GI complications at baseline.|week 0|Baseline population||Participants|||Number
161860|NCT00267150|Primary|Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium|The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.|weeks 6-8|||Change in Score of GSRS||Standard Deviation|Mean
161861|NCT00267111|Secondary|Visual Analogue Scale|Parents and nurses were asked to assess the infant’s pain response during the procedure using Visual analogue scale (VAS) on an unmarked horizontal 10 cm continuous line where 0=“no pain” on the left side and 10=“worst possible pain” on the right side. Parents and nurses were trained to use the VAS prior to the IM injection.|During the entire procedure|Intention to treat analysis||Cms||Standard Deviation|Mean
161862|NCT00267111|Primary|Pain Scores Assessed by Neonatal Facial Action|The presence or absence of 3 facial actions (brow bulge, eyes squeeze and deepening of the nasolabial furrow) were scored in 2 second intervals for the first 20 seconds (or less if the phase lasted < 20 seconds) of each procedure phase from the videotapes by a trained research assistant. The data were then collapsed for each facial action into the percentage of time the infant expressed the action. An overall pain score was computed by summing the percentage scores for the three facial actions and then dividing by three. The score ranged from 0% to 100% with higher values suggesting more pain.|For the purpose of analysis IM injection procedure was divided into 4 phases: baseline , cleansing, injection and recovery phases.. For each phase facial actions were scored for the first 20 seconds or less if the phase lasted < 20 seconds.|Intention to treat analysis||Percentage of time||Standard Deviation|Mean
161863|NCT00267098|Secondary|Incidence of Ventricular Tachyarrhythmias|Among subjects implanted with a Cardiac Resynchronization Therapy with Defibrillation device (CRT-D) and randomized, the endpoint was the time from randomization until the subject experienced a ventricular tachyarrhythmia. For each randomization arm, the number of CRT-D subjects who experienced at least one ventricular tachyarrhythmia post-randomization is reported, as well as the number of CRT-D subjects who did not experience one or more ventricular tachyarrhythmias post-randomization.|Participants were followed for the duration of the study, an average of 37.9 months post-randomization among CRT-D subjects.|"Only randomized subjects in the CRT-D device group were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data recorded by CRT-D devices. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-D: Not Randomized, and all CRT-P subgroups were excluded."||participants|||Number
161864|NCT00267098|Secondary|CRT-P and CRT-D System Implant Success|The endpoint will be whether each subject who underwent an implant attempt of a Cardiac Resynchronization Therapy device, be it a pacing only device (CRT-P) or a pacing device with defibrillation capability (CRT-D), had a successful procedure (i.e. the generator, left ventricular lead, and right ventricular lead were successfully implanted). Only one implant attempt was allowed.|Initial Implant Procedure|"For this outcome measure, only subjects in the No Implant Attempt subgroup were excluded."||participants|||Number
161865|NCT00267098|Secondary|Clinical Composite Score at 24 Months|The endpoint will be a subject's Clinical Composite Score at 24 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 24 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161879|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 12 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit value.|Randomization to 12 Months|||liters per minute per squared meter||Standard Deviation|Mean
162126|NCT00265512|Primary|Rates of Substance Use|Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).|Rates of substance use measured at 3 months|||percentage of days||Standard Error|Mean
161866|NCT00267098|Secondary|Clinical Composite Score at 18 Months|The endpoint will be a subject's Clinical Composite Score at 18 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 18 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161867|NCT00267098|Secondary|Clinical Composite Score at 12 Months|The endpoint will be a subject's Clinical Composite Score at 12 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 12 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161868|NCT00267098|Secondary|Clinical Composite Score at 6 Months|The endpoint will be a subject's Clinical Composite Score at 6 months. The Clinical Composite Score is a 3 point score (Worsened, Unchanged, and Improved) based on a number of factors including: whether the subject has died, whether the subject has experienced a heart failure-related hospitalization, whether the subject has discontinued their therapy due to worsening heart failure, whether their New York Heart Association classification has improved or worsened since randomization, and whether they feel moderately or markedly better since randomization.|Randomization to 6 Months|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161869|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 24 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 24 Months|||ratio||Standard Deviation|Mean
161870|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 18 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 18 Months|||ratio||Standard Deviation|Mean
161871|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 12 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 12 months. The measure for each subject will be the 12 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 12 Months|||ratio||Standard Deviation|Mean
161872|NCT00267098|Secondary|Change in E Wave/A Wave Ratio (E:A Ratio) From Randomization to 6 Months|The endpoint will be a subject's change in E:A ratio (a measure of diastolic function) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit difference in E:A ratio. Typical values for the E:A ratio at a single time point are 1.04 in men and 1.03 in women.|Randomization to 6 Months|||ratio||Standard Deviation|Mean
161873|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 24 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 24 month visit. The measure will be the 24 month - randomization visit difference in IVMD.|Randomization to 24 Months|||ms||Standard Deviation|Mean
161874|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 18 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 18 month visit. The measure will be the 18 month - randomization visit difference in IVMD.|Randomization to 18 Months|||ms||Standard Deviation|Mean
161875|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 12 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 12 month visit. The measure will be the 12 month - randomization visit difference in IVMD.|Randomization to 12 Months|||ms||Standard Deviation|Mean
161876|NCT00267098|Secondary|Change in Interventricular Mechanical Delay (IVMD) From Randomization to 6 Months|The endpoint will be a subject's change in interventricular mechanical delay (a measure of dyssynchrony between ventricles, measured in ms) from randomization to the 6 month visit. The measure will be the 6 month - randomization visit difference in IVMD.|Randomization to 6 Months|||ms||Standard Deviation|Mean
161877|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 24 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 24 months. The measure for each subject will be the 24 month - randomization visit value.|Randomization to 24 Months|||liters per minute per squared meter||Standard Deviation|Mean
161878|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 18 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 18 months. The measure for each subject will be the 18 month - randomization visit value.|Randomization to 18 Months|||liters per minute per squared meter||Standard Deviation|Mean
162127|NCT00265473|Secondary|Insulin Independent Multiple-donor Subjects.|Proportion of insulin independent multiple-donor subjects at one year after final transplant. Participant received more than one islet transplant.|At one year after final transplant|||participants|||Number
161880|NCT00267098|Secondary|Change in Cardiac Index From Randomization to 6 Months|The endpoint will be a subject's change in cardiac index (a measure of how much blood the left ventricle ejects in one minute, normalized over body surface area) from randomization to 6 months. The measure for each subject will be the 6 month - randomization visit value.|Randomization to 6 Months|||liters per minute per squared meter||Standard Deviation|Mean
161881|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 24 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 24 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 24 Months|||percentage of left atrial area||Standard Deviation|Mean
161882|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 18 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 18 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 18 Months|||percentage of left atrial area||Standard Deviation|Mean
161883|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 12 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 12 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 12 Months|||percentage of left atrial area||Standard Deviation|Mean
161884|NCT00267098|Secondary|Change in Mitral Regurgitation From Randomization to 6 Months|The endpoint will be a subject's change in mitral regurgitation (a measure of how much blood flows backwards into the heart due to the mitral valve not closing properly). The measure for each subject will be the 6 month - randomization visit difference in mitral regurgitation. Negative values reflect reductions in mitral regurgitation over time.|Randomization to 6 Months|||percentage of left atrial area||Standard Deviation|Mean
161885|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 24 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 24 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 24 Months|||cm||Standard Deviation|Mean
161886|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 18 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 18 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 18 Months|||cm||Standard Deviation|Mean
161887|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 12 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 12 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 12 Months|||cm||Standard Deviation|Mean
161888|NCT00267098|Secondary|Change in Left Ventricular End Systolic Dimension (LVESD) From Randomization to 6 Months|The endpoint will be a subject's change in LVESD (a measure of the dimension of the left ventricle at the end of systole). For each subject the measure was the 6 month - randomization visit difference in LVESD value. Negative values correspond to reductions in LVESD.|Randomization to 6 Months|||cm||Standard Deviation|Mean
161889|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 24 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 24 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 24 Months|||cm||Standard Deviation|Mean
161890|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 18 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 18 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 18 Months|||cm||Standard Deviation|Mean
161891|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 12 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 12 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 12 Months|||cm||Standard Deviation|Mean
161892|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Dimension (LVEDD) From Randomization to 6 Months|The endpoint will be a subject's change in LVEDD (a measure of the dimension of the left ventricle at the end of diastole). For each subject the measure was the 6 month - randomization visit difference in LVEDD value. Negative values correspond to reductions in LVEDD.|Randomization to 6 Months|||cm||Standard Deviation|Mean
161893|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 24 months. For each subject the measurement was calculated as 24 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 24 Months|||grams||Standard Deviation|Mean
161894|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 18 months. For each subject the measurement was calculated as 18 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 18 Months|||grams||Standard Deviation|Mean
161895|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 12 months. For each subject the measurement was calculated as 12 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 12 Months|||grams||Standard Deviation|Mean
161896|NCT00267098|Secondary|Change in Left Ventricular Mass (LV Mass) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular Mass ( a measure of the size of the left ventricle) from randomization to 6 months. For each subject the measurement was calculated as 6 month - randomization visit difference in LV mass measurement. Negative values correspond to a reduction in LV mass over time.|Randomization to 6 Months|||grams||Standard Deviation|Mean
161897|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 24 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161898|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 18 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161899|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 12 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161900|NCT00267098|Secondary|Change in Left Ventricular End Diastolic Volume Index (LVEDVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Diastolic Volume Index (a measure of the volume of blood in the left ventricle at the end of diastole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVEDVI. Negative values correspond to reductions in LVEDVI over time.|Randomization to 6 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161901|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 24 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 24 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 24 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161902|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 18 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 18 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 18 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161903|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 12 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 12 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 12 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161904|NCT00267098|Secondary|Change in Left Ventricular End Systolic Volume Index (LVESVI) From Randomization to 6 Months|The endpoint will be a subject's change in Left Ventricular End Systolic Volume Index (a measure of the volume of blood in the left ventricle at the end of systole, normalized over body surface area). In other words, a measure of the size of the left ventricle. For each subject the measure is the 6 month - randomization visit difference in LVESVI. Negative values correspond to reductions in LVESVI over time.|Randomization to 6 Months|||ml/square meter of body surface area||Standard Deviation|Mean
161905|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 24 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 24 month - randomization visit difference in LVEF value.|Randomization to 24 Months|||percentage||Standard Deviation|Mean
161906|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 18 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 18 month - randomization visit difference in LVEF value.|Randomization to 18 Months|||percentage||Standard Deviation|Mean
161907|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 12 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 12 month - randomization visit difference in LVEF value.|Randomization to 12 Months|||percentage||Standard Deviation|Mean
161908|NCT00267098|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) From Randomization to 6 Months|The endpoint will be a subject's change in LV Ejection Fraction (a measure of the percentage of blood ejected from the left ventricle of the heart with each contraction). A normal range is 55% to 70%. For each subject the measure will be the 6 month - randomization visit difference in LVEF value.|Randomization to 6 Months|||percentage||Standard Deviation|Mean
162128|NCT00265473|Secondary|Insulin Independent Single-donor Subjects.|Proportion of insulin independent single-donor subjects at day 75 after transplant|At 75 days after transplant|||Participants|||Number
161909|NCT00267098|Secondary|Change in Quality of Life at 24 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 24 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 24 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 24 Months|||units on a scale||Standard Deviation|Mean
161910|NCT00267098|Secondary|Change in Quality of Life at 18 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 18 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 18 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 18 Months|||units on a scale||Standard Deviation|Mean
161911|NCT00267098|Secondary|Change in Quality of Life at 12 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 12 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 12 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 12 months|||units on a scale||Standard Deviation|Mean
161912|NCT00267098|Secondary|Change in Quality of Life at 6 Months|"The endpoint will be a subject's change in Quality of Life score from randomization to 6 months. The Quality of Life score at a time point is calculated using the Minnesota Living with Heart Failure Questionnaire, which consists of 21 questions each on a 6 point scale from 0 to 5. The 21 scores are added up and the final score, ranging from 0 (best) to 105 (worst) is the subject's quality of life score. For each subject the measure will be the randomization visit - 6 month difference in QOL score, with positive values denoting a reduction in score and improvement in Quality of Life.~Subjects with missing QOL scores at one or both time points were excluded from analysis, and so the number of subjects analyzed for this outcome was a subset of the number of randomized subjects."|Randomization to 6 Months|||units on a scale||Standard Deviation|Mean
161913|NCT00267098|Secondary|Cardiovascular-related Healthcare Utilizations|Cardiovascular-related healthcare utilizations (HCUs), such as hospitalizations, Emergency Department visits, urgent care visits, and clinic visits that subjects experienced after being randomized were summarized for each randomization arm|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|||participants|||Number
161914|NCT00267098|Secondary|Frequency of Adverse Events Post-randomization|Adverse events that subjects experienced after they were randomized were compared between arms with regard to several categories such as heart failure (HF)-relatedness, relatedness to the implant procedure, and relatedness to the implanted system, including individual components such as the left ventricular (LV) lead and the CRT-P or CRT-D generator.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|||participants|||Number
161915|NCT00267098|Secondary|Change in Cardiovascular Medications|The endpoints are what classes of drugs (e.g. Beta blockers, Diuretics, Nitrates, etc.) each subject was on at the time of scheduled visits (e.g Randomization, 6 months, 12 months, etc.)|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Because indications for defibrillation devices like CRT-Ds are defined by characteristics that relate to medication guidelines, medication results are presented separately for each device group. Medications were assessed only for subjects who completed visits (denoted as Subjects with Medications Assessed)."||participants|||Number
161916|NCT00267098|Secondary|Change in Heart Failure Stage|The endpoint is a subject's change in Heart Failure Stage (a measure of the degree of heart failure a subject has on a 4 stage scale (A, B, C, D), with Class A being the healthiest score and Class D being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with HF Stage assessed at randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or HF Stage not assessed) are listed under the Comparative data not available category for that time point."||participants|||Number
161917|NCT00267098|Secondary|Change in New York Heart Association Classification|The endpoint is a subject's change in New York Heart Association Classification (a measure of the degree of heart failure a subject has on a 4 class scale, with NYHA I being the healthiest score and NYHA IV being the sickest score) from randomization to each of four time points: 6 months, 12 months, 18 months, and 24 months post-randomization. The change categories listed will be relative to randomization.|Randomization to 24 Months|"For each time point(e.g. 6 months), only subjects with NYHA assessed at both randomization and that time point were included in the analysis. Those who could not be analyzed at a time point(for reasons such as death, exit,missed visit,or NYHA not assessed at visit) are listed under the Comparative data not available category for that time point."||participants|||Number
161959|NCT00266656|Secondary|Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years|Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.||years||Standard Error|Mean
161918|NCT00267098|Secondary|Days Hospitalized for Heart Failure|For each subject the endpoint was the days hospitalized for heart failure per patient year, calculated as the total number of days the subject was hospitalized for heart failure divided by the subject's total follow-up time. Only post-randomization data were used.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||Days hospitalized per patient year||Standard Deviation|Mean
161919|NCT00267098|Secondary|First Heart Failure Hospitalization|The endpoint is the time from randomization to a subject's first heart failure (HF)-related hospitalization. For each randomization arm, the number of subjects who met the endpoint, experiencing at least one heart failure-related hospitalization post-randomization, are reported, as well as the number of randomized subjects who did not experience any HF hospitalizations post-randomization.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161920|NCT00267098|Secondary|All-Cause Mortality or Significant Increase in Left Ventricular End Systolic Volume Index|"The endpoint will be the time from randomization to either death or a visit (6, 12, 18, 24 month or interim visit) in which the subject undergoes an echocardiogram and the measured left ventricular end systolic volume index (a measure of the size of the subject's left ventricle normalized over their body surface area) is at least 15% greater than the corresponding measured value at randomization.~Only LVESVI endpoints/deaths and follow-up data occurring before a subject missed an LVESVI measurement (due to missed visit, echo not performed, etc.) were used in the analysis and included in the table below. The counts reflect the number of subjects meeting each endpoint, and are not mutually exclusive."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161921|NCT00267098|Secondary|All-Cause Mortality or Heart Failure-related Hospitalization|The endpoint will be a subject's time from randomization to either their first heart failure-related hospitalization, or death.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161922|NCT00267098|Secondary|All-Cause Mortality|"The endpoint is the time to death from any cause. The rate of mortality, as measure by the hazard rate, in each randomization arm will be compared.~This outcome includes all post-randomization deaths, whereas the reporting of the primary outcome excluded primary endpoints (including deaths) that occurred after the subject had missed a study-required echocardiogram (used to determine if the LVESVI primary endpoint was met)."|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161923|NCT00267098|Primary|Mortality, Heart Failure-related Urgent Care Visits, or Significant Increase in Left Ventricular End Systolic Volume Index (LVESVI)|Events include all-cause mortality, heart failure(HF)-related urgent care (a healthcare utilization visit involving intravenous(IV) therapy for heart failure) or significant increase(at least 15%) in LVESVI (a measure of the volume of a patient's left ventricle) from randomization to a later time point. Time from randomization until the subject experienced one of these events served as the outcome measure. LVESVI endpoints occurred primarily at those visits in which LVESVI measurements were required (6, 12, 18, 24 months). Because endpoints such as death or HF urgent care could occur at any time during follow-up, the subject's outcome measure could range from less than 1 month to 105 months (maximum follow-up duration). Primary endpoints and follow-up data occurring after a subject missed a required LVESVI measurement were excluded from the analysis and the table below. The counts reflect the number of subjects meeting each endpoint, and are not necessarily mutually exclusive.|Participants were followed for the duration of the study, an average of 39.8 months post-randomization.|"Only randomized subjects in both device groups were included in the analysis of this endpoint, as the analysis was restricted to post-randomization data. Subjects in the No Implant Attempt, Unsuccessful Implants, CRT-P: Not Randomized, and CRT-D: Not Randomized subgroups were excluded."||participants|||Number
161924|NCT00267085|Primary|Response: One Log Decrease in BCR-ABL|Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.|12 months|All 10 participants on study received treatment and were included in analysis.||Participants|||Number
161925|NCT00267059|Primary|Number of Patients in Overall Response Categories|Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.|Evaluated after three 28-day cycles of lenalidomide.|Analysis was intention to treat (ITT): Forty four patients received treatment.||Participants|||Number
161926|NCT00267046|Primary|Median Maximum Score for Patient Reported Outcomes in 2 Blinded Cycles|Median maximum score (0 to 10, with 10 being the worst) for participant-reported outcomes in the first 2 blinded cycles for Mouth Pain, Overall Mouth and Throat Soreness, and Rectal Soreness while median maximum score for Swallowing, Drinking and Eating Difficulty (0 to 4, with 4 being the difficult).|Within the first 2 blinded cycles (3-week cycles), up to 6 weeks.|Intention to treat (ITT).||Units on a scale||Full Range|Median
161927|NCT00267046|Primary|Cumulative Incidence Rate of Oral Mucositis|"Cumulative incidence of World Health Organization (WHO) grade 2 or > mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or > divided by total number of participants who completed up to 6 blinded cycles.~WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive) erythema; swallow liquid, not solid diet. Grade 4: mucositis to extent alimentation not possible."|Within 6 blinded cycles (3-week cycles), up to 18 weeks.|Intention to treat (ITT).||Percentage of Participants||95% Confidence Interval|Mean
161928|NCT00267007|Secondary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 2) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|baseline to Day 128|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.||participants|||Number
161929|NCT00267007|Primary|The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.|NCI CTC neuropathy: a descriptive terminology used to grade the severity of AEs in cancer subjects on a 0-5 scale. A higher score indicates worse peripheral neuropathy.|Baseline to Week 12|MITT(Modified intent to treat)all randomized subjects that received at least one dose and had at least one post-baseline neuropathy assessment.||participants|||Number
161930|NCT00266864|Secondary|Resting Energy Expenditure|Resting Energy Expenditure was obtained by the measurement of exhaled air from fractions of mixed expired oxygen and carbon dioxide by a process known as indirect calorimetry. Data was collected under steady state conditions. Participants arrived at the laboratory for testing between the hours of 8:00 and 10:00 in the morning, following a 12-h fast, with a minimum of 24 h free from any type of exercise.|12 months|||kcal/day||Standard Deviation|Mean
161931|NCT00266864|Primary|Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)|Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the “on-and-off -the-table” method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM.|12 months|||kilograms||Standard Deviation|Mean
161932|NCT00266825|Secondary|Preterm Births|Percentage of births occurring at less than 37 weeks of gestation.|births before week 37 of gestation|||percentage of births|||Number
161933|NCT00266825|Secondary|Head Circumference|Measure of circumference of baby's head in centimeters at time of birth.|at time of birth|||centimeters||Standard Deviation|Mean
161934|NCT00266825|Secondary|Cord RBC-phospholipid-DHA|Percentage of total fatty acids by weight in cord RBC|at time of birth|||percentage of cord RBC||Standard Deviation|Mean
161935|NCT00266825|Secondary|Gender of Babies||at time of birth|||percentage of babies|||Number
161936|NCT00266825|Primary|Birth Length|Length of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||centimeters||Standard Deviation|Mean
161937|NCT00266825|Primary|Birth Weight|Weight of baby at birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||grams||Standard Deviation|Mean
161938|NCT00266825|Primary|Gestational Age|Gestational age of babies at time of birth in days|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||days||Standard Deviation|Mean
161939|NCT00266825|Secondary|Ponderal Index|Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.|at time of birth|||units on a scale||Standard Deviation|Mean
161940|NCT00266825|Primary|Percentage of Total Fatty Acids by Weight|Measure of RBC-phospholipid-DHA at Birth|at time of birth|The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.||percentage of fatty acid||Standard Deviation|Mean
161941|NCT00266812|Primary|Number of Participants With Progression-free Survival (6 Month)|The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as <25% increase in tumor size on CT or MRI.|6 months|Intent to treat (ITT) population (31 of the 35 patients enrolled; 4 participants discontinued prior to start of treatment) was analyzed.||Participants|||Number
161960|NCT00266656|Secondary|Age at Attainment of Tanner 2 Breast Development|The Tanner 2 breast development is the age at first evidence of breast development.|Baseline through End of Study (10 years)|All participants who had a baseline visit and at least one post-baseline visit.||years||Standard Error|Mean
162035|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
161942|NCT00266799|Secondary|Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ))|QoL questionnaire was an EORTC QLQ-C30 & SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle & rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose.|From Screening to Day 1 of every Treatment Cycle up to 12 Cycles|ITT: included all randomized participants. There were only a few participants who completed more than 12 cycles due to the longer duration of each cycle.||Percentage of Participants|||Number
161943|NCT00266799|Secondary|Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups|Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason.|From Day 1 (Cycle 1) until End of Treatment|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.||Months||95% Confidence Interval|Median
161944|NCT00266799|Secondary|Overall Survival Time in the PLD and Capecitabine Treatment Groups|Survival time was defined as duration time from onset of treatment with the study drug until death.|From Day 1 (Cycle 1) until Death|ITT: 7 in PLD group and 3 participants in Capecitabine group were missing response assessments and therefore were not included in the analysis.||Months||95% Confidence Interval|Median
161945|NCT00266799|Secondary|Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups|Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT) population included all randomized participants.||Participants|||Number
161946|NCT00266799|Primary|Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)|TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or – in the absence of any diagnosis of progressive disease – until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.|From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death|Intent-to-treat (ITT): 7 in PLD group & 3 participants in Capecitabine group were missing response assessments. TTP Population: included participants in view of major protocol violations/deviations, i.e. tumor-relevant inclusion/exclusion criteria, treatment compliance, tumor assessments by RECIST with maximum 4 month interval between assessments.||Months||95% Confidence Interval|Median
161947|NCT00266695|Secondary|Number of Participants Receiving Treatment With Panretinal Photocoagulation||Baseline up to Month 24|All enrolled participants.||participants|||Number
161948|NCT00266695|Secondary|Number of Participants Receiving Treatment With Focal/Grid Photocoagulation||Baseline up to Month 24|All enrolled participants.||participants|||Number
161949|NCT00266695|Secondary|Visual Acuity|Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). A higher score represented better VA.|Month 24|All enrolled participants. Last observation carried forward (LOCF).||letters read correctly||Standard Deviation|Mean
161950|NCT00266695|Secondary|Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval|An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed.|Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months|All enrolled participants (pts) at risk during the specified intervals. Pts who did not experience an event during the interval were censored to the last time point in the interval. Number of pts censored: 0 to 6 months = 2 pts, 6 to 12 months = 4 pts, 12 to 18 months = 9 pts, 18 to 24 months = 82 pts, and 24 to 30 months = 90 pts.||participants|||Number
161961|NCT00266656|Secondary|Height SDS at Various Ages|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Age 10, Age 13, Age 16|All participants who had a baseline visit and at least one post-baseline visit.||Standard deviation score||Standard Deviation|Mean
162124|NCT00265512|Secondary|Quality of Life||Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study.||||||
161951|NCT00266695|Secondary|Sustained Moderate Vision Loss (SMVL), Long Term|The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term)|Participants who were treated with 32 milligram (mg) ruboxistaurin once daily in Study MBCM and had at least 1 DR study eye, who were also enrolled in Study MBDV.||participants|||Number
161952|NCT00266695|Secondary|Vision Loss|The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months|All enrolled participants.||participants|||Number
161953|NCT00266695|Primary|Sustained Moderate Visual Loss (SMVL)|The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline, 18 months up to 24 months|All enrolled participants.||participants|||Number
161954|NCT00266656|Secondary|Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
161955|NCT00266656|Secondary|Percentage of Participants With Prevalence of Abnormal Audiometry Results|Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
161956|NCT00266656|Secondary|Percentage of Participants With Abnormal Tympanometry Results|Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint.|Baseline, Age 10, Age 16, End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
161957|NCT00266656|Secondary|Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events|Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||percentage of participants|||Number
161958|NCT00266656|Secondary|Reports of Serious Adverse Events|"Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria).~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Baseline through End of Study (10 years)|All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.||events|||Number
161972|NCT00266630|Secondary|Number of Participants Who Switched to Syndromic Depression|As defined as a shift from a Manic Episode at baseline to a Major Depressive Episode, at any post baseline visit, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.|baseline through 18 weeks|Analyzed were all participants who had a manic episode at baseline.||participants|||Number
161962|NCT00266656|Primary|Most Mature Height Standard Deviation Score (SDS)|SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.|Baseline through End of Study (10 years)|All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.||standard deviation score||Standard Deviation|Mean
161963|NCT00266630|Secondary|Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values|High density lipoprotein: males low 40 milligram/deciliter (mg/dL), high 80 mg/dL; females low 40 mg/dL, high 90 mg/dL. Low density lipoprotein (LDL): males and females low 70 mg/dL, high 139 mg/dL. Hemoglobin A1C (HBA1C): males and females low 4.3%, high 5.8%.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
161964|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)|High QTcF: more than or equal to 450 milliseconds (msec) for males; more than or equal to 470 milliseconds (msec) for females|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements and no abnormal values in the direction at baseline (e.g. participants with an abnormally low value for a given parameter at baseline who showed an abnormally low value for the same parameter at a later visit were not included). Last observation carried forward.||participants|||Number
161965|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight|Low systolic blood pressure (SBP): <=90 millimeter mercury (mmHg) and decrease of >=20 mmHg; High SBP: >=180 mmHg and increase of >=20 mmHg; Low diastolic blood pressure (DBP): <=50 mmHg and decrease of >=15 mmHg; High DBP: >=105 mmHg and increase of >=15 mmHg; Low pulse: <50 beats per minute (bpm) and decrease of >=15 bpm; High pulse: >120 bpm and an increase of >=15 bpm; Low weight: decrease of >=7%; High weight: increase of >=7%;|baseline through 18 weeks|Analyzed were all study participants.||participants|||Number
161966|NCT00266630|Secondary|Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes|Triglycerides: high limit equal to or more than 500 milligram/deciliter (mg/dL); Glucose (non-fasting): low limit 2.4975 mmol/liter (L); high limit 13.875 mmol/L; Glucose (fasting): low limit 2.4975 mmol/L; high limit 6.993 mmol/L.|baseline through 18 weeks|Analyzed were all participants without an abnormal value in the direction at baseline (for example, participants with an abnormally low value at baseline who experienced an abnormally low value at any time post baseline were not included, but were included if they experienced an abnormally high value at any time post baseline).||participants|||Number
161967|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dyskenisia was defined as a score of equal or more than 2 or an increase of equal to or more than 2 points from baseline on the dyskenisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
161968|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dystonia was defined as a score equal or more than 2 or an increase of equal or more than 2 points from baseline on the dystonia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
161969|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent akathisia was defined as a score of equal or more than 2 or an increase of equal or more than 2 points from baseline on the akathisia item (total score possible 0 to 4 points).|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
161970|NCT00266630|Secondary|Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores|DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). Parkinsonism is assessed by the total points of items 1 to 5 (total score of 0 to 20). Treatment-emergent parkinsonism was defined as a score of equal or greater than 3 on 1 item, equal or greater than 2 on 2 items, or an increase of equal or greater than 3 from baseline on the parkinsonism total.|baseline through 18 weeks|Included were all participants who did not have an abnormal value at baseline.||participants|||Number
161971|NCT00266630|Secondary|Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score|A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by the total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by the points given to the corresponding items.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
161973|NCT00266630|Secondary|Positive and Negative Syndrome Scale Positive Scores - Visit Data|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For the analysis, the score was converted to 0 to 6 for each item range; hence, the total score ranges from 0 to 42.|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
161974|NCT00266630|Secondary|Number of Participants Who Experienced Remission of Bipolar Disorder|Participants who had equal to or less than 12 points in YMRS total score and equal to or less than 7 points in HAMD-17 total score at 18 weeks. YMRS: 11-item scale, measures the severity of manic episodes. 4 items are rated from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total: 0 to 60. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale or a 5-point scale. HAMD-17 total score: 0 (normal) to 52 (severe).|Week 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
161975|NCT00266630|Secondary|Number of Participants With Relapse of Depressive Symptoms|Assessed were participants meeting remission criteria for bipolar disorder in Study BMAC and have a HAMD-17 total score greater than or equal to 13 at any time. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who had 12 points or less in the YMRS total score and 7 points or less in the HAMD-17 total score at baseline.||participants|||Number
161976|NCT00266630|Secondary|Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)|Incidence of depressive symptoms was defined as a score of equal to or more than 13 points on the HAMD-17. The 17-item HAMD measures depression severity. Each item was evaluated and scored a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|baseline through 18 weeks|Analyzed were all participants who had equal to or less than 7 points on the HAMD-17 total score at baseline.||participants|||Number
161977|NCT00266630|Secondary|Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data|Measures severity of the patient's overall severity of bipolar symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, Weeks 1, 2, 4, 6, 10, 14, 18|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
161978|NCT00266630|Secondary|Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|baseline through 18 weeks|Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
161979|NCT00266630|Primary|Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only|Patients achieved remission in Study BMAC (defined as YMRS total score <=12 and HAMD-17 total score <=7) and obtained YMRS total score of >=15 at any time during Study BMEX. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy group who were in remission at baseline (end of Study BMAC) with 12 points or less in YMRS total score and 7 points or less in the 17-item Hamilton Depression Rating Scale total score.||participants|||Number
161980|NCT00266630|Primary|Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only|Remission of Mania was defined as a YMRS total score of less than or equal to 12 at endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
161981|NCT00266630|Primary|Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only|Defined by a 50% or more reduction in YMRS total score from baseline in Study BMAC to endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.||participants|||Number
161982|NCT00266630|Primary|Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.|baseline through 18 weeks|The primary objective was only interested in the effects in the olanzapine monotherapy arm, thus the results for the olanzapine + mood stabilizer arm are presented as secondary outcomes. Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.||units on a scale||Standard Deviation|Mean
162125|NCT00265512|Secondary|Psychiatric Symptoms||Psychiatric symptoms and quality of life are measured at baseline, 3 months, 6 months and 12 months after enrollment into the study.||||||
161983|NCT00264849|Secondary|Changes From Baseline to Week 31 in the Percent Activity Impairment Due to Asthma Problems|The Work Productivity and Activity Impairment - Allergic Asthma (WPAI-AA) questionnaire measures time missed from work, impairment of work and regular activities within the last 7 days. Questionnaires were administered via phone 1 week prior to the study visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Activity impairment due to asthma problems is derived from the patients assessment of the degree to which asthma problems affected regular activities. A negative change from baseline indicates improvement.|Baseline and Week 31|Modified Intent-to-Treat. Only patients with a value at both baseline and Week 31 visit were included. Sensitivity analysis excluded questionnaires which were answered after the clinic visit.||percent impairment||Standard Deviation|Mean
161984|NCT00264849|Secondary|Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems|The Work Productivity and Activity Impairment-Allergic Asthma (WPAI-AA) questionnaire measures time missed from work, impairment of work and regular activities within the last 7 days. Questionnaires were administered via phone 1 week prior to the study visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Overall work impairment due to asthma problems is derived from the proportion of hours missed from work due to asthma and the degree to which asthma problems affected productivity while working.|Baseline and Week 31|Modified Intent-to-Treat. Only patients only who worked and with values at both baseline and Week 31 visit were included. Sensitivity analysis excluded questionnaires which were answered after the clinic visit.||percent impairment||Standard Deviation|Mean
161985|NCT00264849|Secondary|Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31|"The utility-based EQ-5D questionnaire is in two parts and provides a generic measure of health for clinical and economic appraisal. The first health state classification part has 5 questions each with 3 categories (no problem, moderate problem, severe problems). The second visual analogue scale was measured from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline, Week 15, Week 31|Modified Intent-to-Treat with N count as noted in category description.||units on a scale||95% Confidence Interval|Least Squares Mean
161986|NCT00264849|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit|There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1–totally limited/problems all the time, 7–not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|Baseline, Week 15, Week 31|mITT at Week 15 for OAT + Omalizumab is 214 patients and for OAT is 92 patients; at Week 31 for OAT + Omalizumab is 224 patients and for OAT is 97 patients except as noted in the category description. To be included in this table patients must have a AQLQ measurement for the specified timepoint.||units on a scale||95% Confidence Interval|Least Squares Mean
161987|NCT00264849|Secondary|Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32|The type of change for the dose of maintenance systemic steroids could be presented as removal (no more maintenance systemic steroids used), decreased, or maintained.|Weeks 16 and 32|mITT patients with systemic steroids at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6).||participants|||Number
161988|NCT00264849|Secondary|Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32|For the subgroup of patients requiring maintenance oral (systemic) corticosteroids throughout the screening period the dose of oral steroid (expressed as prednisolone equivalent dose) at baseline, Week 16 and Week 32 was presented by treatment group, as well as the absolute and percent change from baseline to Weeks 16 and 32. It should be noted that the dose of oral steroid at Weeks 16 and 32 was the dose the patient was maintained on and not the dose to treat an exacerbation if one occurred at that time.|Weeks 16 and 32|mITT patients with systemic steriods at baseline (defined as those patient who used systemic steroids throughout the entire run-in period from Visit 1 to Visit 6). N counts as noted in the category description.||percent change||Standard Deviation|Mean
161989|NCT00264849|Secondary|Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period|A combined total of unscheduled visits due to asthma exacerbations was calculated for each patient as the total number of hospital admissions, ER visits and unscheduled outpatient clinical visits due to asthma exacerbation. Where more than one type of visit was required on a single day for an asthma exacerbation only the most serious type was included. Where there was more than one visit for a single asthma exacerbation but the visits occurred on different dates, then all were counted.|32 Weeks|Modified Intent-to-Treat (mITT)||participants|||Number
161990|NCT00264849|Secondary|Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period|A clinically significant exacerbation episode was defined as a worsening of asthma requiring treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the rescue systemic corticosteroids marked the start of a clinically significant asthma exacerbation episode and cessation of the rescue systemic corticosteroids regimen marked the end of a clinically significant exacerbation episode. If an exacerbation episode was duplicated, overlapped by at least one day with another episode, or nested within another exacerbation episode, only one exacerbation was counted.|32 Weeks|mITT||participants|||Number
161991|NCT00264849|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ has six questions to be answered by the patient, each with a 7 point scale (0–good control, 6–poor control), and one question where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms.|Baseline, Week 16, Week 32|mITT with N counts as noted in the category description. To be included in this table patients must have a ACQ measurement for the specified timepoint.||units on a scale||95% Confidence Interval|Least Squares Mean
161992|NCT00264849|Secondary|Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)|Predicted FEV1 was calculated using the Crapo formula for data at Visit 6 (time of randomization), (MALES: Predicted FEV1 (L) = 0.0414*height - 0.0244*age -2.190 and Females: Predicted FEV1 (L) = 0.0342*height - 0.0255*age - 1.578, where height is in cm).|Weeks 16 and 32|Modified Intent-to-Treat (mITT), for Week 16 N=258/106 for OAT+Omalizumab/OAT and for Week 32 N=266/121 for OAT+Omalizumab/OAT, respectively.||percent predicted FEV1||95% Confidence Interval|Least Squares Mean
161993|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE|Responders were defined as excellent or good based on the patient's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|mITT population and patients who were assessed for persistency of response or non-response at Week 16 and had a GETE obtained >= 4 weeks after the Week 16 assessment or discontinued prematurely or unsatisfactory therapeutic effect >= 4 weeks after the Week 16 assessment. N=187/28 for OAT+Omalizumab/OAT for responders and N=71/63 for non-responders.||percentage of participants||95% Confidence Interval|Number
161994|NCT00264849|Secondary|Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32|Number of participants with persistent response, based on the patient's GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)||participants|||Number
161995|NCT00264849|Secondary|Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE|Responders were defined as excellent or good based on the investigator's Global Evaluation of Treatment Effectiveness (GETE) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)||percentage of participants||95% Confidence Interval|Number
161996|NCT00264849|Secondary|Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32|Number of participants with persistent response, based on the investigator’s GETE, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. Persistency was defined as the proportion of responders at 16 weeks who were still responders at 32 weeks. GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.|Weeks 16 and 32|Modified Intent-to-Treat (mITT)||participants|||Number
161997|NCT00264849|Primary|Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)|Persistency of response, based on GETE, was dichotomized into responders (excellent or good) and non-responders (moderate, poor or worsening). Persistent responders were patients who were responders at 16 weeks and still at 32 weeks. Persistent non-responders were patients who were non-responders at 16 weeks and still at 32 weeks. Patients were assessed for persistency of response if they were responders at Week 16 and had a second GETE obtained ≥ 4 weeks after the Week 16 assessment or discontinued prematurely for unsatisfactory therapeutic effect ≥ 4 weeks after the Week 16 assessment.|Weeks 16 and 32|Modified Intent-to-Treat (mITT) was defined for efficacy analyses which included all randomized patients who had at least one post-baseline efficacy assessment.||participants|||Number
161998|NCT00264810|Primary|Change in Frequency of Disabling Seizures|"The outcome measure is met when a significantly greater reduction in the frequency of total disabling seizures in seen in the Treatment group when compared to the Sham group, during the Blinded Evaluation Period (BEP) relative to the Pre-Implant Period (Baseline).~The outcome measure is the group-by-time interaction term in a generalized estimating equation (GEE), longitudinal regression model, where group refers to therapy allocation (Treatment or Sham), time refers to study period (Baseline or BEP), and the dependent variable is seizure frequency. The outcome measure was a statistically significant group-by-time interaction term, which would demonstrate a significantly greater reduction in seizure frequency in the Treatment group than the Sham group during BEP compared to Baseline Period.~Primary Effectiveness Outcome Measure was met.~(Note: Disabling seizures = motor simple partial seizures or complex partial seizures with or without secondarily generalized seizures.)"|3 months pre-implant (Baseline Period) compared to months 3, 4 and 5 post-implant (Blinded Evaluation Period)|||Seizure frequency % change from Baseline||95% Confidence Interval|Number
161999|NCT00264810|Primary|Short-term Chronic SAE Rate|"RNS® System Short-term Chronic SAE rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 42%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Oh et al., 2002; SSED, Activa Tremor Control System P960009; Beric et al., 2001; Behrens et al., 1997; Hariz, 2002; Joint et al., 2002; Koller et al., 2001).~Primary Safety Outcome Measure was met."|Initial implant through 5 months post-implant|||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
162000|NCT00264810|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 15%; upper CI = 20%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable. Referenced literature are listed within the citation section (Tanriverdi et al., 2009; Wong et al., 2009; Fountas and Smith, 2007; Hamer et al., 2002; Behrens et al., 1997).~Primary Safety Outcome Measure was met."|Initial implant through 1 month post-implant|||percentage of subjects with ≥ 1 SAE||95% Confidence Interval|Number
162001|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Per Protocol Population (subjects of ITT population who have no major protocol violations)||cumulative percent of responders|||Number
162002|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period|Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
162003|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks||8 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162004|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks||7 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162005|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks||6 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162006|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks||5 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162007|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks||4 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162008|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks||3 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162009|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks||2 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162010|NCT00266409|Secondary|Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week||1 week|ITT population, but only patients with non-missing assessments were included||participants|||Number
162011|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
162012|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162013|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162014|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162015|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162016|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162017|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162018|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162019|NCT00266409|Secondary|Change From Baseline in HAM-A-somatic Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
163682|NCT00246376|Primary|Triglycerides|Triglycerides (mg/dL): Fasting lipid levels|Measured at 24 weeks|All those who underwent the 2-week (first follow-up) measurement and continued in the study.||mg/dL||Standard Error|Mean
162020|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
162021|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162022|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162023|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162024|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162025|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162026|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 3 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162027|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162028|NCT00266409|Secondary|Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162029|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
162030|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162031|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 7 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162032|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 6 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162033|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 5 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162034|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162036|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 2 weeks|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162037|NCT00266409|Secondary|Change From Baseline in HAM-A-insomnia Subscore After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.|Baseline and 1 week|ITT population, but only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162038|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
162039|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|8 weeks|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
162040|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|7 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162041|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|6 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162042|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|5 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162043|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|4 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162044|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|3 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162045|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.|2 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162046|NCT00266409|Secondary|Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week|The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).|1 week|ITT population, but only patients with non-missing values are included in the analysis||participants|||Number
162047|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, but only subjects with non-missing values have been included||participants|||Number
162048|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 8 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162049|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 4 weeks|ITT population, but only subjects with non-missing values have been included||participants|||Number
162050|NCT00266409|Secondary|Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks|The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).|Baseline and 2 weeks|ITT population, but only patients with non-missing values were included||Participants|||Number
162129|NCT00265473|Secondary|Subjects With Partial Islet Function and no Episodes of Severe Hypoglycemia;|Proportion of subjects with partial islet function and no episodes of severe hypoglycemia at one year after initial islet transplant.|At one year after initial transplant|||Participants|||Number
162051|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.|at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||participants|||Number
162052|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|8 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162053|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|7 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162054|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|6 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162055|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|5 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162056|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|4 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162057|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|3 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162058|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|2 weeks|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162059|NCT00266409|Secondary|Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|1 week|ITT population, but only patients with a non-missing value at timepoint are included in the analysis||participants|||Number
162060|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.|Baseline and at endpoint during the 8 week treatment period|ITT population, Last Observation Carried Forward imputation was applied||Units on a scale||Standard Deviation|Mean
162061|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 8 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 8 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162062|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 7 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 7 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162063|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 6 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 6 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162064|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 5 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 5 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162065|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 4 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 4 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162066|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 3 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 3 weeks|ITT population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
168569|NCT00145626|Secondary|Number of Incidences of Chronic GVHD.|The estimate of the incidence of chronic GVHD will be obtained using Binomial distribution.|Up to 5 years after transplant||||||
162067|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 2 Weeks|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 2 Weeks|ITT Population, only subjects with non-missing values have been included||Units on a scale||Standard Deviation|Mean
162068|NCT00266409|Secondary|Change From Baseline in the Total HAM-A Score After 1 Week|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.|Baseline and 1 week|ITT population, but only subjects with values at baseline and time point are included in the analysis||Units on a scale||Standard Deviation|Mean
162069|NCT00266409|Primary|Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)|The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.|10 weeks|Intent-to-treat population||cumulative percent of responders|||Number
162070|NCT00266279|Secondary|Qualitative and Quantitative Toxicity|The most common toxicities were grades 1 or 2 fatigue and anemia .|Every two 28 day treatment cycles||12/2018||||
162071|NCT00266279|Primary|Response Rate||Every two 28 day treatment cycles|||Participants|||Number
162072|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Low Disease at Week 48|The DAS28-ESR score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-ESR scores range from 0 - 10. Low disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2.|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
162073|NCT00266227|Secondary|Percentage of Retreated Subjects Achieving DAS28-ESR Remission at Week 48|DAS28-ESR remission was defined as a DAS28-ESR < 2.6|Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
162074|NCT00266227|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) at Week 48 in Retreated Subjects|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all randomized participants, with data available for analyses.||Score on a scale||Full Range|Median
162075|NCT00266227|Secondary|Change From Baseline in SF-36 Health Summary Scores at Week 48 in Retreated Subjects|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Score on a scale||Standard Deviation|Mean
162076|NCT00266227|Secondary|ACRn in Retreated Subjects at Week 48|The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). A positive ACRn Score indicates an improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Score on a scale||Standard Deviation|Mean
162077|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.3 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
162078|NCT00266227|Secondary|Percentage of Retreated Subjects With a Change ≥ 0.22 From Baseline in HAQ-DI at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Percentage of participants|||Number
162079|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Erythrocyte Sedimentation (ESR) at Week 48|Blood was collected for Erythrocyte Sedimentation Rate, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||millimeter/hour (mm/hr)||Standard Deviation|Mean
162080|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48|Blood was collected for C-Reactive Protein, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat Population includes all participants randomized to Retreatment.||mg/dL||Standard Deviation|Mean
162081|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Assessment of Pain at Week 48|Patients rated their pain at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (none) to 100 (unbearable pain). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment with data available for analyses.||millimeter (mm)||Standard Deviation|Mean
162082|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Physician's Global Assessment of Disease Activity at Week 48|A Rheumatologist or a skilled Arthritis assessor rated the patient's disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||millimeter (mm)||Standard Deviation|Mean
162083|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Subject's Global Assessment of Disease Activity at Week 48|Participants rated their disease activity at baseline and Week 48 using the Visual Analog Scale (VAS) on a scale of 0 (best) to 100 (worse). A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||millimeter (mm)||Standard Deviation|Mean
162084|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 48|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Score on a scale||Standard Deviation|Mean
162085|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Tender Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 68 joints at baseline and at Week 48. A negative change from baseline in the Tender Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Joint Count||Standard Deviation|Mean
162086|NCT00266227|Secondary|Change From Baseline in American College of Rheumatology (ACR) Core Set Component: Swollen Joint Count at Week 48|A Rheumatologist or an skilled arthritis assessor evaluated 66 joints at baseline and at Week 48. A negative change from baseline in Swollen Joint Count indicates improvement.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Joint Count||Standard Deviation|Mean
162087|NCT00266227|Secondary|Percentage of Retreated Subjects With a European League Against Rheumatism (EULAR) Response at Week 48|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Percentage of participants|||Number
162088|NCT00266227|Secondary|Change From Baseline in Disease Activity Score (DAS28-CRP) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline, Week 48|Participants from the Intent-to-treat population that includes all participants randomized to Retreatment with data available for analyses.||Units on a scale||Standard Deviation|Mean
162089|NCT00266227|Secondary|Change From Baseline in the Disease Activity Score Using 28 Joint Counts (DAS28-ESR) at Week 48|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|48 weeks|Participants from the Intent-to-treat population, that includes all participants randomized to Retreatment, with data available for analyses.||Units on a scale||Standard Deviation|Mean
162090|NCT00266227|Secondary|Retreated Subjects With American College of Rheumatology 50% (ACR50) Response and American College of Rheumatology 70% (ACR70) Response at Week 48 Relative to Baseline|ACR50 or ACR70 response was defined as a ≥ 50% or 70% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 50% or 70% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|Baseline, Week 48|Intent-to-treat population includes all participants randomized to Retreatment.||Participants|||Number
162091|NCT00266227|Primary|Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline|ACR20 response was defined as a ≥ 20% improvement compared with baseline in both tender joint count (TJC) [68 joints] and swollen joint count (SJC) [66 joints] as well as a ≥ 20% improvement in three of five additional measurements: 1) Physician's Global Assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [visual analog scale: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [visual analog scale: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) erythrocyte sedimentation rate.|48 Weeks|Intent-to-treat population includes all participants randomized to Retreatment.||Participants|||Number
162092|NCT00264797|Secondary|Substance Use Outcomes|The mean number of negative urine drug screens (UDS).|20 weeks|All randomized participants.||negative UDS||Standard Deviation|Mean
162093|NCT00264797|Secondary|OROS-MPH Abuse Liability|Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.|20 weeks|All randomized participants.||pills||Standard Deviation|Mean
162094|NCT00264797|Primary|Substance Use|The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures.|20 weeks|All randomized participants.||days||95% Confidence Interval|Mean
162095|NCT00264797|Primary|ADHD Severity|DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time.|baseline and 20 weeks|All randomized participants.||units on a scale||Standard Deviation|Mean
162096|NCT00266032|Post-Hoc|Pearl Index (FDA Criteria)|Following an FDA request another PI evaluation was done for the first year of treatment only and taking into consideration also pregnancies with a conception date within 14 days after end of the study medication. Restricting the analysis to the required first year of treatment, it results in this PI estimation.|Up to one year|FAS||Pregnancies per 100 woman years||95% Confidence Interval|Mean
162097|NCT00266032|Post-Hoc|Number of Unintended Pregnancies Including Pregnancies Occuring Within 14 Days After End of Study Medication.|Pregnancies with conception date during treatment and within 14 days after end of study medication were included.|Up to one year|FAS||Pregnancies|||Number
162098|NCT00266032|Secondary|Days With Scheduled Versus Unscheduled Bleeding|Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation||Days||Standard Deviation|Mean
162099|NCT00266032|Secondary|Number of Bleeding / Spotting Episodes in 90 Day Reference Period|The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.|Up to one year|FAS (reflecting ITT), all treated subjects, no imputation||Episodes||Standard Deviation|Mean
162100|NCT00266032|Secondary|Number of Bleeding / Spotting Days by 90-day Reference Period|The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.|up to 1 year|FAS (reflecting ITT), all treated subjects, no imputation||Days||Standard Deviation|Mean
162101|NCT00266032|Secondary|Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days|For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.|up to 1 year|FAS (reflecting ITT population), all treated subjects, no imputation||Days||Standard Deviation|Mean
162102|NCT00266032|Secondary|Number of Days With Bleeding Excluding Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.|up to 1 year|FAS||Days||Standard Deviation|Mean
162103|NCT00266032|Primary|Adjusted Pearl Index|The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||Pregnancies per 100 woman years||95% Confidence Interval|Mean
162104|NCT00266032|Primary|Number of Unintended Pregnancies Due to Method Failure|Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||Pregnancies|||Number
162105|NCT00266032|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.|Up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||Pregnancies per 100 woman years||95% Confidence Interval|Mean
162106|NCT00266032|Primary|Number of Unintended Pregnancies in Yaz Flexible Arm|Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.|up to 2 years|Full Analysis Set (reflecting ITT population), all treated subjects, no imputation, including switchers to flexible treatment in second year||pregnancies|||Number
162130|NCT00265473|Primary|Serious Adverse Events Related to Immunosuppressive Therapy.|Number of serious adverse events related to immunosuppressive therapy.|Day 0 - Day 365|||Serious Adverse Events|||Number
162107|NCT00266032|Primary|Number of Days With Bleeding Including Spotting|The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.|up to 1 year|Full Analysis Set (FAS) (reflecting Intention To Treat (ITT) population), all treated subjects with data available, no imputation||days||Standard Deviation|Mean
162108|NCT00265889|Primary|Number of Patients That Experience Pulmonary Toxicity|Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.|One year after second transplant|Analysis is per protocol, so includes patients who received treatment||participants|||Number
162109|NCT00265889|Primary|Response Rate|Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|One year after second transplant|Analysis is per protocol, so includes patients who received both transplants||participants|||Number
162110|NCT00265889|Primary|Progression-free Survival|Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.|one year after second transplant|Analysis is per protocol, so includes patients who received both transplants||participants|||Number
162111|NCT00265798|Secondary|Overall Survival|Overall survival will be defined as time from the start of treatment until death from any cause.|Up to 5 years|||months||95% Confidence Interval|Median
162112|NCT00265798|Secondary|Progression-free Survival|"Progression-free survival will be defined as time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death, whichever comes first.~CT scans for disease reassessment will be obtained pre-therapy and every 8 weeks."|Up to 5 years|||months||95% Confidence Interval|Median
162113|NCT00265798|Primary|Objective Response Rate|"Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response."|Up to 5 years|||percentage of partcipants||95% Confidence Interval|Number
162114|NCT00265785|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
162115|NCT00265785|Secondary|Response (Confirmed and Unconfirmed, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.|Eligible and analyzable patients with measurable disease at baseline are included in this measure.||percentage of participants||95% Confidence Interval|Number
162116|NCT00265785|Primary|Overall Survival|Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.||months||95% Confidence Interval|Median
162117|NCT00265785|Secondary|Progression-free Survival|Progression is defined as any one or more of the following: 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is defined as globabl deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Progression-free survival is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|Eligible and analyzable patients were included in this measure.||months||95% Confidence Interval|Median
162118|NCT00265616|Secondary|Intubation Time in Survivors||Up to 3 months|||days||Full Range|Median
162119|NCT00265616|Primary|Refractory Status Epilepticus Controlled With First Course of Study Drug|Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)|after return of continuous EEG activity (typically after 36 hours - 5 days)|Number of patients fulfilling primary outcome criteria||participants|||Number
162120|NCT00265616|Secondary|Patients With Propofol Infusion Syndrome|Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.|10 days|||participants|||Number
162121|NCT00265616|Secondary|Patients With Hypotension Requiring Specific Treatment||10 days|||participants|||Number
162122|NCT00265616|Secondary|Patients With Infectious Complications Requiring Specific Treatment||10 days|||participants|||Number
162123|NCT00265616|Secondary|Clinical Outcome at Day 21|Return to baseline clinical conditions (i.e.: no new handicap, no death)|21 days|||participants|||Number
162131|NCT00265473|Primary|Subjects With Full Islet Function.|Proportion of subjects with full islet function (i.e. insulin independent) at one year after initial islet transplant.|At one year after initial transplant.|The number of participants was based on the participants that were actually transplanted.||Participants|||Number
162132|NCT00265395|Primary|Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.|LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)|48 or 72 weeks of treatment plus 24 weeks of follow-up.|According to the protocol, the efficacy analysis was carried out on all slow responders (ie, patients who had at least 2 log drop in HCV-RNA level at treatment week 12, and undetectable HCV-RNA at treatment week 24).||Participants|||Number
162133|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||participants|||Number
162134|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||participants|||Number
162135|NCT00265382|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||participants|||Number
162136|NCT00265382|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162137|NCT00265382|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|"CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the normal range; lower score indicates need for increased supervision."|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162138|NCT00265382|Secondary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162146|NCT00265382|Secondary|Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment|Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 26, Early Termination (ET)|Safety Analysis Set. N=number of subjects with analyzable data at baseline. Baseline data from Study A1281134 (NCT00257192) served as the baseline for A1281135.||participants|||Number
162139|NCT00265382|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162140|NCT00265382|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162141|NCT00265382|Secondary|Change From Baseline in Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162142|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162143|NCT00265382|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Weeks 6 and 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162144|NCT00265382|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162145|NCT00265382|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Weeks 2, 6, 18, 26, ET|Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point.||scores on a scale||Standard Deviation|Mean
162147|NCT00265382|Primary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|26 weeks|Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0% AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold.||participants|||Number
162148|NCT00265343|Secondary|Change in Quality of Life Measured by Quality of Life Scale (QLS)|Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population||Units on a Scale||Standard Error|Least Squares Mean
162149|NCT00265343|Primary|Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale|Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].|Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)|Intent-to-treat population||Units on a Scale||Standard Error|Least Squares Mean
162150|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF - All Subjects|QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)|||participants|||Number
162151|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Females|QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)|||participants|||Number
162152|NCT00265330|Primary|Frequency of Largest Categorical Increases in QTcF for Males|QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.|Week 26 (end of study)|||participants|||Number
162153|NCT00265330|Primary|Mean Change From Baseline for QTcF Intervals|QT intervals (observed in an electrocardiogram)corrected using Fridericia’s formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.|Baseline to Week 26 (end of study)|||millisecond||Standard Deviation|Mean
162154|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 26|||participants|||Number
162155|NCT00265330|Primary|Body Mass Index (BMI) Z-score Frequency|change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6|||participants|||Number
162156|NCT00265330|Primary|Mean Change From Baseline for Body Mass Index (BMI) Z-Score|mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change|Week 6, 26, early termination|||score on scale||Standard Deviation|Mean
162157|NCT00265330|Primary|Mean Change From Baseline for Body Weight|Mean change; body weight value at observation minus body weight value at baseline.|Week 6, Week 26|||kilogram||Standard Deviation|Mean
162158|NCT00265330|Primary|Mean Change From Baseline in Standing Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||beats per minute||Standard Deviation|Mean
162159|NCT00265330|Primary|Mean Change From Baseline in Standing Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||mm Hg||Standard Deviation|Mean
162160|NCT00265330|Primary|Mean Change From Baseline in Standing Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||mm Hg||Standard Deviation|Mean
162161|NCT00265330|Primary|Mean Change From Baseline in Supine Pulse Rates|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||beats per minute||Standard Deviation|Mean
162162|NCT00265330|Primary|Mean Change From Baseline in Supine Diastolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||millimeters mercury (mm Hg)||Standard Deviation|Mean
162163|NCT00265330|Primary|Mean Change From Baseline in Supine Systolic Blood Pressure|Mean Change: vital sign value at observation minus vital sign value at baseline|Week 1 through Week 26|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
162164|NCT00265330|Primary|Change in Hormones|Mean Change: lab value at observation minus lab value at baseline|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)||nanogram/deciliter (ng/dL)||Standard Deviation|Mean
162165|NCT00265330|Primary|Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol|Mean Change: lab value at observation minus lab value at baseline.|Week 6, Week 26|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)||milligram /deciliter (mg/dL)||Standard Deviation|Mean
162166|NCT00265330|Primary|Incidence of Lab Abnormalities|number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.|Week 26|Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115)||participants|||Number
162167|NCT00265330|Primary|Clinical Global Impression of Severity (CGI-S) Change From Baseline|CGI-S Scale:standardized assessment tool to rate severity of subject’s illness; assesses investigator’s impression of subject’s current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).|baseline and 26 Weeks; 26 Weeks LOCF|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)||score on scale||Standard Deviation|Mean
162168|NCT00265330|Primary|Young Mania Rating Scale (YMRS) Total Score Change From Baseline|YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.|baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)|The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)||score on scale||Standard Deviation|Mean
162169|NCT00265317|Secondary|Plasma Concentration of Soluble KIT (sKIT) at Baseline||Baseline (Cycle 1, Day 1)|FA Set||pg/mL||Full Range|Median
162170|NCT00265317|Secondary|Plasma Concentration of Soluble VEGFR-3 at Baseline||Baseline (Cycle 1, Day 1)|FA Set||pg/mL||Full Range|Median
162173|NCT00265317|Secondary|Number of Participants on Anti-hypertensive Medications|Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.|Randomization to Day 28 of Cycle 18|Per Protocol Set; data were not analyzed|||||
162174|NCT00265317|Secondary|Number of Participants With BP Greater Than 200/110 mmHg|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set||Participants|||Number
162175|NCT00265317|Secondary|Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)|Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.|Randomization up until Month 17|Per-Protocol Set: all participants in the Phase 2 portion (randomized) who received at least 1 dose of study medication (either erlotinib or blinded medication) with treatment assignments designated according to actual study medication received||Participants|||Number
162176|NCT00265317|Secondary|EORTC-QLQ-C30 Lung Cancer Module (LC13) Score|The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)|PRO Analysis Set; n is number of participants with an assessment at the specific time point||score on a scale||95% Confidence Interval|Mean
162177|NCT00265317|Other Pre-specified|sKIT Ratio to Baseline at Each Timepoint|Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
162178|NCT00265317|Secondary|Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score|EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1|Patient-Reported Outcome (PRO) Analysis Set: participants from the FA Set who had at least 1 EORTC QLQ-C30 or EORTC QLQ Lung cancer (QLQ-LC13) module questionnaire assessment while on treatment; n is number of participants with an assessment at the specified time point.||score on a scale||95% Confidence Interval|Mean
162179|NCT00265317|Other Pre-specified|VEGFR-3 Ratio to Baseline at Each Timepoint|Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
162180|NCT00265317|Secondary|PFS in Subgroups That Were Defined by RNA Expression Profile|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162181|NCT00265317|Other Pre-specified|VEGFR-2 Ratio to Baseline at Each Timepoint|Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
162182|NCT00265317|Secondary|Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile|Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
162183|NCT00265317|Other Pre-specified|VEGF-C Ratio to Baseline at Each Timepoint|Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)|Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)|FA Set; n equals number of participants with evaluable data at specified cycle||Ratio||Full Range|Median
162184|NCT00265317|Secondary|Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts|A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.|Baseline (Day 1, Cycle 1)|Blood samples were collected; however, because of the small sample size that resulted in a lack of power for statistical testing, no formal statistical analyses were performed.|||||
163919|NCT00243061|Secondary|Response Duration||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 years|||months|||Number
162185|NCT00265317|Secondary|Percentage of Participants by Tumor VEGFR Mutation|Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|Full Analysis - All Population; data were not analyzed|||||
162186|NCT00265317|Secondary|OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population||Months||95% Confidence Interval|Median
162187|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population||Weeks||95% Confidence Interval|Median
162188|NCT00265317|Secondary|Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms|Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.|Baseline|Full Analysis - All Population||Percentage of Participants||95% Confidence Interval|Number
162189|NCT00265317|Secondary|Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.|From randomization until death (up to Month 17)|Per Protocol Caucasian Population||Months||95% Confidence Interval|Median
162190|NCT00265317|Secondary|PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Per Protocol Caucasian Population: all Caucasian participants in randomized phase who received at least 1 dose of study medication (either erlotinib or blinded medication), with treatment assignments designated according to actual study medication received||Weeks||95% Confidence Interval|Median
162191|NCT00265317|Secondary|Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms|Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.|Baseline|Full Analysis - All Population: all participants from lead-in period and Phase 2 (randomized phase)||Percentage of Participants||95% Confidence Interval|Number
162192|NCT00265317|Secondary|PFS in Subgroups That Were Defined by KRAS Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162193|NCT00265317|Secondary|Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations|Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set||Percentage of Participants|||Number
162194|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Mutation|PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162195|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Mutation|Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.|Baseline|FA Set||Percentage of Participants|||Number
162196|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Amplification|PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162197|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Amplification|The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
162198|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase|PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162199|NCT00265317|Secondary|Percentage of Participants With EGFR Gene Copy Number Increase|The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.|Baseline|FA Set||Percentage of Participants|||Number
162200|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162201|NCT00265317|Secondary|Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)|Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
162202|NCT00265317|Secondary|PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)|PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162203|NCT00265317|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff|Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.|Baseline|FA Set||Percentage of Participants|||Number
162204|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
162205|NCT00265317|Secondary|Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
162206|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
162221|NCT00265317|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib|AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf])|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, AUC(0-inf) could not be accurately estimated.|||||
162207|NCT00265317|Secondary|Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||ng/mL||Standard Deviation|Mean
162208|NCT00265317|Secondary|Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||mcg/mL||Standard Deviation|Mean
162209|NCT00265317|Secondary|Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)|Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.|predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)|Number of participants analyzed (N)=participants with observations above lower limit of quantification (LLOQ) in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle||mcg/mL||Standard Deviation|Mean
162210|NCT00265317|Secondary|Tmax for Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||Hours||Full Range|Median
162211|NCT00265317|Secondary|Tmax for SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||Hours||Full Range|Median
162212|NCT00265317|Secondary|Tmax for Sunitinib||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||Hours||Full Range|Median
162213|NCT00265317|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib||Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A||Hours||Full Range|Median
162214|NCT00265317|Secondary|Sunitinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Number of participants with calculable data in Original Lead-In Cohort; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 48 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm B.||L/hr||Standard Deviation|Mean
162215|NCT00265317|Secondary|Erlotinib Clearance at Steady State After Oral Administration (CL/F)||Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Number of participants with calculable data in Original Lead-In; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 24 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm A.||Liters (L)/hr||Standard Deviation|Mean
162216|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Sunitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, t1/2 could not be accurately estimated.|||||
162217|NCT00265317|Secondary|Plasma Decay Half-life (t1/2) of Erlotinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, t1/2 could not be accurately estimated.|||||
162218|NCT00265317|Secondary|AUC(0-inf) for Total Drug (Sunitinib + SU-012662)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.|||||
162219|NCT00265317|Secondary|AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)|AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.|||||
162220|NCT00265317|Secondary|AUC(0-inf) for Sunitinib|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)|Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.|||||
162222|NCT00265317|Secondary|Cmax of Total Drug (Sunitinib + SU-012662)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||ng/mL||Standard Deviation|Mean
162223|NCT00265317|Secondary|Cmax of SU-012662 (Metabolite of Sunitinib)||Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose|Amended Lead-In Cohort Arm B||ng/mL||Standard Deviation|Mean
162226|NCT00265317|Secondary|AUC(0-24) of Total Drug (Sunitinib + SU-012662)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B||ng*hr/mL||Standard Deviation|Mean
162227|NCT00265317|Secondary|AUC(0-24) of SU-012662 (Metabolite of Sunitinib)|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B||ng*hr/mL||Standard Deviation|Mean
162228|NCT00265317|Secondary|AUC(0-24) of Sunitinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib|Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-In Cohort Arm B: participants received sunitinib for 28 days each cycle (13 days in Cycle 1) and erlotinib QD for 28 days each cycle (26 days in Cycle 1).||nanograms (ng)*hr/mL||Standard Deviation|Mean
162229|NCT00265317|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib|AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib|Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose|Amended Lead-in Cohort Arm A: participants received sunitinib QD for 28 days each cycle (27 days in Cycle 1) and erlotinib QD for 28 days each cycle (7 days in Cycle 1)||micrograms (mcg)*hour(hr)/milliliter (mL||Standard Deviation|Mean
162230|NCT00265317|Secondary|Percentage of Participants Surviving at 1 Year|Percentage of participants alive at 1 year after date of first administration of study medication.|From randomization until death (up until Month 17)|FA Set||Percentage of Participants|||Number
162231|NCT00265317|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.|From randomization until death (up to Month 17)|FA Set||Months||95% Confidence Interval|Median
162232|NCT00265317|Secondary|Duration of Response (DR)|DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA subset of participants with a confirmed objective response were to be analyzed. As only 3 and 2 responses were observed, duration of response was not analyzed.|||||
162233|NCT00265317|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Weeks||95% Confidence Interval|Median
162234|NCT00265317|Secondary|Percentage of Participants With Objective Response|Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|FA Set||Percentage of Participants||95% Confidence Interval|Number
162235|NCT00265317|Primary|Progression-Free Survival (PFS)|PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to [≥]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.|From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)|Full Analysis Set (FA):all participants in randomized phase randomized with study medication assignment designated according to initial randomization, regardless of whether participants actually received study medication or received different medication from what they were randomized.||Weeks||95% Confidence Interval|Median
162236|NCT00265239|Primary|Nonfatal Ischemic Stroke|number of nonfatal ischemic stroke|415days|||events|||Number
162237|NCT00265239|Primary|Refractory Angina Pectoris|number of refractory angina pectoris|415days|||events|||Number
162238|NCT00265239|Primary|Nonfatal Myocardial Reinfarction|number of nonfatal myocardial reinfarction|415days|||events|||Number
162239|NCT00265239|Primary|Cardiac Death|number of cardiac death|415±32 days|||events|||Number
162240|NCT00265122|Secondary|Number of Participants in Population 1 With Clinical Remission at Week 8|The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score < 150 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.||participants|||Number
162241|NCT00265122|Secondary|Number of Participants in Population 2 With a Clinical Response at Week 8|The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.||participants|||Number
162242|NCT00265122|Primary|Number of Participants in Population 1 With a Clinical Response at Week 8|The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn’s disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being. The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.|Week 8|The analysis included all randomized patients (ITT), regardless of whether they had any protocol deviations.||participants|||Number
162243|NCT00265109|Secondary|Body Dysmorphic Disorder Clinical Global Impressions Scale; Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory;||Past week||||||
162244|NCT00265109|Primary|Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)|The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0–48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.|Baseline to end week 12|Analyses of the primary outcome measure were intention to treat (ITT) analyses.||Participants|||Number
162245|NCT00265096|Secondary|American College of Rheumatology 20 at Week 24|"Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24.~ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])"|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|ITT. Patients considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. Wk 16 ACR response was used for patients with change in study treatment.||P a r t i c ip an t s|||Number
162246|NCT00265096|Primary|Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24|Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage.|Baseline and Week 24|Intent-to-treat analysis.||Scores on a scale||Standard Deviation|Mean
162247|NCT00265096|Secondary|Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14|The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.|Baseline and Week 14|Intention to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF).||scores on a scale||Standard Deviation|Mean
162248|NCT00265096|Secondary|Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24|Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.|Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24|Intention to treat (ITT). Missing scores were imputed by LOCF. Week (Wk) 16 scores were used for patients with change in study treatment. Week 16 HAQ scores were used for patients with change in study treatment.||scores on a scale||Inter-Quartile Range|Median
162249|NCT00265096|Secondary|Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline|Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14.|Baseline, Week 4, Week 8 and Week 14|In a subset of patients with ≥ 3 percent body surface area (BSA) psoriasis skin involvement at baseline. Missing scores were imputed by Last Observation Carried Forward (LOCF).||Participants|||Number
162250|NCT00265096|Primary|American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP])|Baseline (Week 0), Week 4, Week 8 and Week 14|Intention to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
162343|NCT00263328|Secondary|Trough Levels of Tacrolimus (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ng/mL||Standard Deviation|Mean
162251|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14|The Bath Ankylosing Spondylitis Metrology Index (BASMI) is the sum of scores comprised of 5 measures (0=mild, 1=moderate & 2=severe): Tragus-to-wall; Lumbar flexion; Cervical rotation; Lumbar side flexion; Intermalleolar distance. BASMI ranges from 0 to 10. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASMI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASMI at Week 14 was imputed by Last Observation Carried Forward (LOCF).||Change from baseline in BASMI Index||Standard Deviation|Mean
162252|NCT00265083|Secondary|Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14|The Bath Ankylosing Spondylitis Functional Index (BASFI) is calculated as the mean of 10 VAS, each of length 0 to 10 cm. Eight of the scales relate to functional capacity of patients while the other 2 relate to a patient’s ability to cope with everyday life. Change from baseline is Wk 14 value minus baseline value.|From Baseline to Week 14|Intent to treat (ITT). Patients considered non-change from baseline in BASFI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASFI at Week 14 was imputed by Last Observation Carried Forward (LOCF).||Change from baseline in BASFI Index||Inter-Quartile Range|Median
162253|NCT00265083|Secondary|Assessment in Ankylosing Spondylitis 20 Responders at Week 24|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 24 at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 24|ITT. Patients (pts) considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ASAS components were imputed by LOCF unless all ASAS components are missing in which case considered non-responders. Wk 16 ASAS response was used for pts with change in study treatment.||P a r t i c ip an t s|||Number
162254|NCT00265083|Primary|Assessment in Ankylosing Spondylitis 20 Responders at Week 14|Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.|Week 14|Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ASAS components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ASAS components are missing in which case considered non-responders.||Participants|||Number
162255|NCT00264576|Secondary|Number of Subjects Reporting Local and Systemic Reactions|"Safety and tolerability of cTIV and eTIV_f postvaccination.~Difference between demography and safety numbers was due to one misrandomization."|7 days postvaccination|Analysis was done on safety set||Subjects|||Number
162256|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
162257|NCT00264576|Secondary|Percentages of Subjects With Seroconversion.|As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is >40%.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages||95% Confidence Interval|Number
162258|NCT00264576|Secondary|Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.|"Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay.~This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Percentages||95% Confidence Interval|Number
162259|NCT00264576|Secondary|Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method|Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
162260|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Ratio||95% Confidence Interval|Geometric Mean
162261|NCT00264576|Secondary|Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|"Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.~The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5."|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Ratio||95% Confidence Interval|Geometric Mean
162262|NCT00264576|Primary|Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.|Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.|3 weeks postvaccination (Day 22)|Analysis was done on per protocol set||Titer||95% Confidence Interval|Geometric Mean
162263|NCT00264550|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24|The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group||Units on a scale||Inter-Quartile Range|Median
162264|NCT00264550|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 14|All participants randomly assigned to each treatment group||Units on a scale||Inter-Quartile Range|Median
162265|NCT00264550|Secondary|Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).|Week 24|All participants randomly assigned to each treatment group||Participants|||Number
162266|NCT00264550|Primary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24|HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).|Baseline (Week 0) and Week 24|All participants randomly assigned to each treatment group||Units on a scale||Inter-Quartile Range|Median
162267|NCT00264550|Secondary|Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14|DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant’s global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).|Week 14|All participants randomly assigned to each treatment group||Participants|||Number
162268|NCT00264550|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 14|All participants randomly assigned to each treatment group||Participants|||Number
162269|NCT00264537|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group who had C-reactive protein > 1.0 mg/dl at baseline.||Scores on a scale||Standard Deviation|Mean
162270|NCT00264537|Primary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52|The vdH-S score is the sum of the joint erosion score and the joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.|Baseline and Week 52|All participants randomly assigned to each treatment group.||Scores on a scale||Standard Deviation|Mean
162271|NCT00264537|Secondary|Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Randomized participants with abnormal baseline CRP. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||Participants|||Number
162272|NCT00264537|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24|ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 20 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||Participants|||Number
162375|NCT00263328|Secondary|Total Cholesterol Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
162273|NCT00264537|Primary|Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|All participants randomly assigned to each treatment group. Participants considered non-responders if used any prohibited medications or discontinued subcutaneous study agent due to lack of efficacy. Missing ACR components imputed by Last Observation Carried Forward unless all ACR components were missing; in which case considered non-responders.||Participants|||Number
162274|NCT00264498|Primary|Progression Free Survival (PFS)|Interval between date of randomization and earliest date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression|Date of randomization to earliest date of objective disease progression|||Days||95% Confidence Interval|Mean
162275|NCT00264381|Secondary|Change From Baseline to Day 14 in Pain Assessment|Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain|Day 1, Day 14|Participants available at follow up||units on a scale||Standard Deviation|Mean
162276|NCT00264381|Primary|Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months|Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.|3 months|Participants available for follow up||participants|||Number
162277|NCT00264381|Primary|Thrombosis Progression and Venous Thromboembolism (VTE)|Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing|Day 14|Total number available for follow up||participants|||Number
162278|NCT00264381|Secondary|Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.|Number of participants with bleeding events related to treatment|3 months|||participants|||Number
162279|NCT00264303|Primary|Mean Pruritus Severity Score Over the First Week of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.|over the first week of treatment|ITT population||Units on a scale||Standard Error|Least Squares Mean
162280|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the Four Weeks of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
162281|NCT00264303|Secondary|Mean Score for Pruritus Duration Over the First Week of Treatment|The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.|over the first week of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
162282|NCT00264303|Secondary|Mean Pruritus Severity Score Over the Four Weeks of Treatment|Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
162283|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment|CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.|over the four weeks of treatment|Intent to treat (ITT) Population||Units on a scale||Standard Error|Least Squares Mean
162284|NCT00264303|Secondary|Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment|CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment.|over the first week of treatment|Intent to treat (ITT) population||Units on a scale||Standard Error|Least Squares Mean
162285|NCT00264290|Secondary|Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period||Week 12||||||
162286|NCT00264290|Secondary|Change in CMV DNA Shedding After a 4-week Washout Period||Week 12||||||
162287|NCT00264290|Secondary|%CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period||Week 12||||||
162288|NCT00264290|Secondary|Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8.||week 8||||||
162289|NCT00264290|Secondary|Change in CMV DNA Shedding From Baseline to Week 8.|Change in percentage of participants with detectable CMV DNA. Herpesvirus DNA levels were assessed by polymerase chain reaction (lower limit of detection, 150 copies/mL) on saliva and seminal plasma.|week 8||||||
162290|NCT00264290|Primary|Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.|The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.|Baseline, 8 weeks|||percentage of activated T cells||95% Confidence Interval|Mean
162291|NCT00264147|Secondary|Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treated Population||Units on a Scale||Standard Deviation|Mean
162292|NCT00264147|Secondary|Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0 indicates very well, 4 indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population||Units on a Scale||Standard Deviation|Mean
162410|NCT00262873|Primary|Number of Participants Who Experienced Cytopenias||21 Days/course for up to 12 courses|This data was not collected.|||||
162293|NCT00264147|Secondary|Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)|0-mm indicates very well, 100-mm indicates very poor.|Time-weighted average change from baseline across Weeks 2, 7, and 12|All Patients-Treated Population||Units on a Scale||Standard Deviation|Mean
162294|NCT00264147|Secondary|Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population||Swollen Joint Count||Standard Deviation|Mean
162295|NCT00264147|Secondary|Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)||Time-weighted average change from baseline across Weeks 2, 7, and 12|All-Patients-Treatment Population||Tender Joint Count||Standard Deviation|Mean
162296|NCT00264147|Primary|Proportion of Patients Who Met the ACR20 Responder Index Criteria|Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)|12 weeks|All-Patients-Treated Population||Proportion of Patients|||Number
162297|NCT00264004|Secondary|Best Percentage Change in Tumour Size|Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.|Randomisation until end of treatment period|||percentage of tumor size||90% Confidence Interval|Geometric Mean
162298|NCT00264004|Secondary|Objective Response Rate|Number of patients with complete or partial response (CR/PR), based on RECIST|12 week treatment period|||Participants|||Number
162299|NCT00264004|Secondary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171||First 6 weeks of 12 week treatment period|||Participants|||Number
162300|NCT00264004|Primary|Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171|Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)|12 week treatment period|||Poportion of Planned Dose||90% Confidence Interval|Median
162301|NCT00264004|Primary|Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171||12 week treatment period|||Participants|||Number
162302|NCT00263887|Secondary|Quality of Life With a Disease Specific Instrument, the St. George's Respiratory Questionnaire||24 or 30 months||||||
162303|NCT00263887|Secondary|Mortality||24 or 30 months||||||
162304|NCT00263887|Secondary|Duration and Severity of the Exacerbations||24 or 30 months||||||
162305|NCT00263887|Secondary|The Deterioration of the Lung Function Will be Assessed by Measurement of the Change in Forced Expiratory Volume at One Second (FEV1) and Transfer Factor of Carbon Monoxide (KCO)||24 or 30 months||||||
162306|NCT00263887|Secondary|The Frequency of Exacerbations as Determined by Patient Diary.||24 or 30 months||||||
162307|NCT00263887|Secondary|Change in Lung Density at Each Visit as Measured by Computed Tomography||24 or 30 months||||||
162308|NCT00263887|Primary|The Progression Rate of Emphysema Determined by Change in 15th Percentile of Lung Density Measured by Annual CT Scan of the Whole Lung||24 or 30 months|The modified Intent-To-Treat Population was defined as all subjects in the Intent-To-Treat (ITT) Population (all randomized subjects) who had a valid baseline CT scan and at least one valid post-baseline CT scan measurement.||g/L||Standard Deviation|Mean
162309|NCT00263757|Secondary|Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a disease-specific quality of life questionnaire to determine functional status in adults. The measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living. There are 30 items on the questionnaire consisting of 5 factor subscales. The subject rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty). A higher score indicates greater difficulty or impact of sleepiness on daily living. FOSQ total score ranges from 0 (no difficulty) to 120 (extreme difficulty).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, some due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the FOSQ, and at the 12 month visit 4 participants completed the FOSQ, due to withdrawals."||units on a scale||Standard Deviation|Mean
162310|NCT00263757|Secondary|Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit|The ESS is a measure of general level of sleepiness. The ESS asks subjects to rate their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily live, although not necessarily every day. The questionnaire has 8 questions, with responses ranging from 0 (would never dose) to 3 (high chance of dozing). Therefore the total score could range from 0 (no sleepiness) to 24 (high chance of dozing).|baseline, 12 months|"Usual Care Arm: At the baseline visit 13 participants completed the ESS, and at the 12 month visit 6 participants completed the ESS, due to withdrawals.~Therapeutic Positive Airway Pressure Arm: At the baseline visit 12 participants completed the ESS, and at the 12 month visit 5 participants completed the ESS, due to withdrawals."||units on a scale||Standard Deviation|Mean
162311|NCT00263757|Primary|Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year||1 year|||participants|||Number
162312|NCT00263666|Secondary|Number of Subjects With the RV in Stool Samples|Number of subjects with presence of RV in stool samples (shedding) collected at pre-determined time points by RV type (Yes, No, Mixed type and results not available [NA]).|From Dose 1 until post Dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available||Subjects|||Number
162313|NCT00263666|Secondary|Enteric Pathogens Identification.|Number of gastroenteritis (GE) episodes classified by enteric pathogen tests results.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the subjects from the Total Vaccinated Cohort with gastroenteritis episodes reported between the first dose and the last visit and for whom stools were collected||number of GE episodes|||Number
162314|NCT00263666|Secondary|Rotavirus Vaccine Strain Identification.|"Number of gastroenteritis (GE) episodes classified by rotavirus vaccine strain/serotype.~Unknown: These samples were typed post hoc and found “G1P8” vaccine type for one subject in HRV group, “G3P8” and “G2P4” for subjects in placebo group."|From dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort.||Number of episodes|||Number
162315|NCT00263666|Secondary|Rotavirus in Diarrheal Stool Samples|Number of subjects reporting at least one rotavirus (vaccine strain or wild type rotavirus) gastroenteritis episode.|From Dose 1 until 2 months after dose 3 or until end of RV shedding|Analysis was performed on the Total Vaccinated Cohort||Number of episodes|||Number
162316|NCT00263666|Secondary|Rotavirus Antigen Excretion in Stool Samples|Number of subjects with rotavirus detected by Enzyme Linked Immunosorbent Assay (ELISA) in stool samples collected from Dose 1 until study end|At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding|The analysis was performed on the According to Protocol Cohort for immunogenicity.||subjects|||Number
162317|NCT00263666|Secondary|Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.||Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity||titer||95% Confidence Interval|Geometric Mean
162318|NCT00263666|Secondary|Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value|The cut-off value was ≥ 1:8. The lowest dilution at which serum samples were tested was 1:8, from which a test was considered positive.|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
162319|NCT00263666|Secondary|Geometric Mean Concentration for Anti-BPT Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||ELISA-Units/milliliter||95% Confidence Interval|Geometric Mean
162320|NCT00263666|Secondary|Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 15 Enzyme Linked Immunosorbent Assay Unit/milliliter(EL.U/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
162321|NCT00263666|Secondary|Geometric Mean Concentration for Anti-HBs Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||Milli International Units/milliliter||95% Confidence Interval|Geometric Mean
162322|NCT00263666|Secondary|Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 10 milli international units/milliliter (mIU/mL).|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
162323|NCT00263666|Secondary|Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||International Units / milliliter||95% Confidence Interval|Geometric Mean
162324|NCT00263666|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value|The cut-off value was ≥ 0.1 International Units/milliliter (IU/mL)|Two months after dose 3|The analysis was performed on the According To Protocol cohort for immunogenicity.||subjects|||Number
162325|NCT00263666|Secondary|Geometric Mean Concentration for Anti-PRP Antibodies.||Two months after dose 3|The analysis was performed on the According to Protocol cohort for immunogenicity.||microgram/milliliter||95% Confidence Interval|Geometric Mean
162326|NCT00263666|Secondary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.|Cut-off values for anti-PRP antibody concentrations were ≥ 0.15 and ≥ 1.0 microgram/milliliter (µg/mL).|Two months after dose 3|The analysis was performed on the According To Protocol Cohort for immunogenicity||subjects|||Number
162327|NCT00263666|Secondary|Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations are given as geometric mean concentrations (GMC) for anti-rotavirus IgA antibodies.|Two months after dose 3|"The analysis was performed on the According To Protocol Cohort for immunogenicity for whom data were available.~In the placebo group, GMCs were all < 20 U/ml, hence values were not computed."||Units/milliliter||95% Confidence Interval|Geometric Mean
162328|NCT00263666|Secondary|Number of Subjects With Vaccine Take.|Vaccine take: appearance of serum IgA to rotavirus at a concentration of ≥ 20 U/ml or rotavirus shedding in any stool sample collected from the Screening Visit to 2 months after dose 3 for subjects initially negative for rotavirus.|Two months after the dose 3|Analysis was performed on subjects from the According To Protocol Cohort for immunogenicity for whom data were available||subjects|||Number
162329|NCT00263666|Secondary|Number of Subjects Who Seroconverted Against Rotavirus|A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.|Two months after dose 3|Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available||subjects|||Number
162330|NCT00263666|Secondary|Human Immunodeficiency Virus (HIV) Viral Load|Mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).|At the screening visit and 2 months after dose 3.|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.||base-10 logarithm of copies/milliliter||Standard Deviation|Mean
162331|NCT00263666|Secondary|The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.|Severe suppression: CD4+ cells/microliter (μl) < 750 and CD4+ percent < 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.|At the screening visit and 2 months after dose 3 (Visit 4).|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.||subjects|||Number
162332|NCT00263666|Secondary|Number of Subjects Reporting Each Type of Solicited Symptom.|Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.|Within the 15-day solicited follow-up period after each dose|Analysis was performed on the Total Vaccinated Cohort, which included vaccinated subjects for whom data were available.||subjects|||Number
162411|NCT00262873|Primary|Number of Participants Who Experienced an Adverse Event||For 21 days/course for up to 12 courses|patients enrolled to receive study drug||participants|||Number
162333|NCT00263666|Secondary|Number of Subjects Reporting Any Serious Adverse Events.|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3).|Analysis was performed on the Total Vaccinated Cohort||subjects|||Number
162334|NCT00263666|Secondary|Number of Subjects Reporting Any Unsolicited Symptoms.|An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 30 days after each dose|Analysis was performed on the Total Vaccinated Cohort||subjects|||Number
162335|NCT00263666|Primary|Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.|"Symptoms reported in the table include:~Fever: temperature (axillary route) > 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day."|Within the 15-day solicited follow-up period after any dose.|The analysis was performed on the Total Vaccinated Cohort which included the vaccinated subjects for whom data were available.||subjects|||Number
162336|NCT00263328|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire|HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||events||Standard Deviation|Mean
162337|NCT00263328|Secondary|Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
162338|NCT00263328|Secondary|End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale|"ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
162339|NCT00263328|Secondary|Change From Baseline in SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
162340|NCT00263328|Secondary|SF-36 v2 Subscale Scores by Visit|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
162341|NCT00263328|Secondary|Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement."|Baseline, Months 12, 18, and 24|Safety population; n=number of participants in Safety population per visit with non-missing value.||scores on a scale||Standard Deviation|Mean
162342|NCT00263328|Secondary|Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale|"The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."|Months 12, 18, and 24|Safety population; n=number of participants in Safety Population per visit with non-missing value.||score on a scale||Standard Deviation|Mean
162344|NCT00263328|Secondary|Tofacitinib Concentrations in Plasma (ng/mL) by Visit||Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ng/mL||Standard Deviation|Mean
162345|NCT00263328|Secondary|Fasting Serum Glucose Levels (mg/dL) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
162346|NCT00263328|Secondary|HOMA Insulin Resistance (IR) by Visit|HOMA-IR=fasting serum insulin*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.||HOMA-IR||Standard Deviation|Mean
162347|NCT00263328|Secondary|AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit|The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population: n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.||microU*h/mL||Standard Deviation|Mean
162348|NCT00263328|Secondary|Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit|Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT with data (non-missing) at that particular visit.||mg*h/dL||Standard Deviation|Mean
162349|NCT00263328|Secondary|Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit|Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.|Months 12 and 24|Safety population; n=number of participants eligible for OGTT and had data (non-missing) at that particular visit.||ratio of serum proinsulin to insulin||Standard Deviation|Mean
162350|NCT00263328|Secondary|Homeostatic Model Assessment (HOMA)-%B by Visit|HOMA-%B = (20 times [*] fasting serum insulin) divided by (/) (fasting serum glucose minus [-] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.|Months 12 and 24|Safety population; n=number of participants who were eligible for OGTT and had data (non-missing) at that particular visit.||%B||Standard Deviation|Mean
162351|NCT00263328|Secondary|Hemoglobin A1c (HbA1c) Levels by Visit||Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||% HbA1c||Standard Deviation|Mean
162352|NCT00263328|Secondary|Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit||Months 12 and 24|Safety population||cells/uL||Standard Deviation|Mean
162353|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit|Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162354|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit|Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162355|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit|Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for â‰¥6 consecutive weeks, or death.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162356|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit|Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162357|NCT00263328|Secondary|Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Months 12, 18, 24, 36, 48, 60, 72, 84, and 96|FAS||percentage of participants|||Number
162449|NCT00262314|Primary|Severe Neutropenia (Annual Follow-Up Phase)|Number of infections associated with severe neutropenia at onset during the annual follow-up phase|up to 5 years|participants with annual follow up data||number of infections|||Number
162358|NCT00263328|Secondary|Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR|Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.|Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98)|FAS||percentage of participants|||Number
162359|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit|Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|FAS; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162360|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit|Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162361|NCT00263328|Secondary|Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162362|NCT00263328|Secondary|BK Virus (BKV) DNA Levels Determined Using PCR by Visit|Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||number of copies/PCR||Standard Deviation|Mean
162363|NCT00263328|Secondary|Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit|EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and >1000 copies/PCR.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162364|NCT00263328|Secondary|Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit|Calculated as number of copies per 500 mg DNA.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||number of copies/500 mg DNA||Standard Deviation|Mean
162365|NCT00263328|Secondary|Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162366|NCT00263328|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162367|NCT00263328|Secondary|Percentage of Participants Requiring Lipid-Lowering Agents by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162368|NCT00263328|Secondary|Serum Triglyceride Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
162369|NCT00263328|Secondary|Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162370|NCT00263328|Secondary|Ratio of Serum LDL Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ratio||Standard Deviation|Mean
162371|NCT00263328|Secondary|Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162372|NCT00263328|Secondary|Ratio of Total Serum Cholesterol Level to HDL Level by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||ratio||Standard Deviation|Mean
162373|NCT00263328|Secondary|High-Density Lipoprotein (HDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
162374|NCT00263328|Secondary|Low-Density Lipoprotein (LDL) Levels by Visit||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
162376|NCT00263328|Secondary|Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit|Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels â‰¥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose â‰¥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose â‰¥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. Participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis.||percentage of participants|||Number
162377|NCT00263328|Secondary|Reciprocal of Serum Creatinine||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||dL/mg||Standard Deviation|Mean
162378|NCT00263328|Secondary|Calculated GFR Using Cockcroft-Gault Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)*(140 minus age in years) divided by (72*serum creatinine [mg/dL]). For females value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
162379|NCT00263328|Secondary|Calculated GFR Using the Nankivell Equation (mL/Min)|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine [in millimoles per liter (mmol/L)]) plus (0.25*body weight [in kilograms (kg)]) minus (0.5*serum urea [mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea]) minus (100 per height [in meters] square) plus (35 for male/25 for female). A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mL/min||Standard Deviation|Mean
162380|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit|Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Full Analysis Set (FAS): all participants who received at least 1 dose of study medication. n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162381|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit|Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162382|NCT00263328|Primary|Percentage of Participants With Hypertriglyceridemia by Visit|Hypertriglyceridemia was defined as triglyceride levels of >200 mg/dL or 2.3 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162383|NCT00263328|Primary|Percentage of Participants With Hypercholesterolemia|Hypercholesterolemia was defined as cholesterol levels >240 mg/dL or 6.2 mmol/L.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||percentage of participants|||Number
162384|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit|Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (â‰¥)30 days.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162450|NCT00262314|Primary|Severe Neutropenia (Treatment Phase)|Number of infections associated with severe neutropenia at onset during the treatment phase|up to 36 months|||number of infections|||Number
163920|NCT00243061|Secondary|Survival Rate||At 1 year|||percentage of participants||95% Confidence Interval|Number
163921|NCT00243061|Secondary|Median Survival Time||Up to 6 years|||months||95% Confidence Interval|Median
162385|NCT00263328|Primary|Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit|Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.|Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96|Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.||percentage of participants|||Number
162386|NCT00263328|Primary|Serum Creatinine Levels||Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mg/dL||Standard Deviation|Mean
162387|NCT00263328|Primary|Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation|GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 * (serum creatinine [in milligrams per deciliter (mg/dL)])^(-0.999) * (age in years)^(-0.176) * (0.762 if female) * (1.18 if black) * (blood urea nitrogen [BUN] concentration [mg/dL])^(-0.170) * (serum albumin concentration [in grams per dL (g/dL)])^(0.318). A normal GFR is >90 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min/1.73 m^2 indicated kidney failure.|Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)|Safety population; n=number of participants assessed for the specified parameter at a given visit.||mL/min/1.73 m^2||Standard Deviation|Mean
162388|NCT00262964|Primary|Change From Baseline in Hepatic Insulin Sensitivity Index|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index (HISI) is measured as the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
162389|NCT00262964|Primary|Change From Baseline in Skeletal Muscle Insulin Sensitivity|Changes in skeletal muscle insulin sensitivity (SMIS). SMIS was measured as the increase in skeletal muscle glucose uptake from time zero to the end of a nine hour euglycemic clamp and insulin infusion study. This increase is the percentage change from time zero to end of insulin infusion at nine hours.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||percent increase||Standard Error|Mean
162390|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity in Fenofibrate and Niacin Groups|The baseline and post-treatment measures of adipose tissue insulin sensitivity (ATIS) were compared. ATIS at both timepoints is the suppression from fasting levels of free fatty acid release from adipose tissue (lipolysis) during an insulin infusion as part of a euglycemic clamp study. It is the percent decrease from time zero to the end of the nine hour euglycemic hyperinsulinemic clamp|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|||percent decrease||Standard Error|Mean
162391|NCT00262964|Secondary|Change From Baseline in Very Low-density Lipoprotein Triglyceride Concentration|Change from baseline in very low-density lipoprotein triglyceride concentration (VLDL-Tg)|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||mmol/l||Standard Error|Mean
162392|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Production Rate|VLDL-TG production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||(μmol/L/min)||Standard Error|Mean
162393|NCT00262964|Secondary|Change From Baseline in VLDL-Tg Clearance Rate|Very low density lipoprotein triglyceride (VLDL-Tg) clearance rate, a measure of VLDL-triglyceride removal from plasma per minute.|baseline to end of treatment: 8 weeks (fenofibrate), 16 weeks (niacin)|||(ml/min)||Standard Error|Mean
162394|NCT00262964|Secondary|Change From Baseline in Very Low Density Lipoprotein Apolipoprotein B Production Rate|VLDL-apolipoprotein B (apoB) concentrations were measured as part of a VLDL metabolism study utilizing stable isotope tracers. VLDL apoB production rate, a measure of hepatic secretion of VLDL-apolipoproteinB-100 per liter of plasma per minute.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|||nmol/l/min||Standard Error|Mean
162395|NCT00262964|Primary|Hepatic Fat Content for Fenofibrate and Niacin Groups|Hepatic fat content as measured by magnetic resonance spectroscopy. A PRESS sequence was used. The results from three 10 cubic centimeter voxels positioned within the liver were averaged. The measure is a ratio of triglyceride signal to total signal.|baseline to post intervention: 8 weeks (fenofibrate), 16 weeks (niacin)|10 (or more) subjects in each group would be sufficient for detecting changes in IHTG.||ratio||Standard Deviation|Mean
162396|NCT00262964|Primary|Adipose Tissue Insulin Sensitivity|The ability of insulin to suppress the release of fatty acids from adipose tissue: Adipose tissue insulin sensitivity, measured as the suppression from baseline of free fatty acid release from adipose tissue (lipolysis) during insulin infusion as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp|||percent decrease||Standard Error|Mean
162397|NCT00262964|Primary|Percent Increase in Skeletal Muscle Insulin Sensitivity During Insulin Infusion.|A precise measure of the ability of insulin to stimulate glucose uptake by skeletal muscle. Skeletal muscle insulin sensitivity, measured as the increase from baseline in skeletal muscle glucose uptake during insulin infusion(percentage)as part of a nine hour euglycemic hyperinsulinemic clamp study.|baseline cross-sectional data pre and post nine hour euglycemic clamp|||percent increase||Standard Error|Mean
162398|NCT00262964|Secondary|Very Low Density Lipoprotein - Triglyceride Production Rate|Very low density lipoprotein triglyceride (VLDL-TG) production rate, a measure of hepatic secretion of VLDL-triglyceride per liter of plasma per minute (μmol/L/min).|baseline cross-sectional data|||μmol/L/min||Standard Error|Mean
162451|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase|up to 5 years|participants with annual follow up data||participants|||Number
163922|NCT00243061|Primary|Prolonged Stable Disease According to RECIST||Up to 6 months|||participants|||Number
162399|NCT00262964|Primary|Hepatic Insulin Sensitivity Index (HISI)|Hepatic insulin sensitivity, assessed as a function of glucose production rate and plasma insulin concentration. The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance [10000/(μmol/min)] multiplied by insulin concentration[mU/L]. The 10000 in the formula is a conventional adjustment so that insulin sensitivity measures are more readable. As yet there is no normal range for HISI, since is a surrogate marker for hepatic insulin sensitivity that has not yet been validated.|baseline cross-sectional data|number of subjects determined by power calculations. Analysis was per protocol. Intrahepatic triglyceride was determined by magnetic resonance spectroscopy.||[10000/(μmol/min)x(mU/L)]||Standard Error|Mean
162400|NCT00262951|Secondary|Overall Survival|In all patients, measured from the date of the patient’s registration in this study, until the date of the patient’s death or date last known alive (if observation was censored).|Up to 5 Years or Date of Death, Whichever Occurred First|||Months||95% Confidence Interval|Median
162401|NCT00262951|Primary|Number of Patients in Whom Tumor Was Resectable|Tumor response is measured in terms of resectability, as measured by CT scan at 2 weeks after completion of each course. A CT scan of the chest abdomen and pelvis will be performed in order to evaluate for the presence of metastatic disease. If no metastatic disease, emphasis will be paid to the local tumor. Evaluation of the growth/regression of the tumor will be made as it relates to resectability. If potential for resection then surgery will be recommended. This protocol will be followed after each cycle.|Up to 5 Years or Until Disease Progression|||Participants|||Number
162402|NCT00262925|Secondary|Overall Survival|Time from registration to death from any cause. Patients alive were censored at follow up.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|||months||95% Confidence Interval|Median
162403|NCT00262925|Primary|Complete Response Rate|"Complete response requires that all of the following be present for at least four weeks.~1. Peripheral Blood Counts: Neutrophil count >= 1.0 x 109/L, Platelet count >= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood.~2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines, <= 5% blasts.~3. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present."|assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry|all enrolled patients||percentage of participants||95% Confidence Interval|Number
162404|NCT00262873|Secondary|Average Number of Leukemia Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline bone marrow was only available on 5 participants||number of colonies per 50000 cell plated||Standard Deviation|Mean
162405|NCT00262873|Secondary|Average Number of Erthroid Burst Forming Units in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|analysis was performed on only four participants||number of colonies per 50000 cell plated||Standard Deviation|Mean
162406|NCT00262873|Secondary|Average Number of Colony Forming Unit-granulocyte-macrophages in Bone Marrow|Colony forming unit-granulocyte-macrophage (CFU-GM) progenitors, erythroid burst forming units (BFU-E), and leukemia colony forming units (CFU-L) were measured at day 0 and day 14 of cycle 1. Five × 10(4) light density cell for granulocyte-macrophage colony forming unit (CFU-GM) or erythroid burst forming unit (BFU-E) assays were plated in 0.9% methylcellulose, 30% FCS, 2 mmol/L L-glutamine, 10−4 mol/L β-mercaptoethanol, and 1% BSA with 3U/ml human erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, and 50 ng/ml stem cell factor (SCF) (c-kit ligand). For leukemia colony forming units (CFU-Ls), the plating mixture was comparable with the exception that the cytokines utilized were 4 U/ml erythropoietin, 10 ng/ml GM-CSF, 10 ng/ml IL-3, 100 ng/ml c-kit ligand, and 100 ng/ml Flt3 ligand. The methylcellulose mixture and associated reagents were purchased from Stem Cell Technologies (Vancouver, BC). Colonies were scored at Day 14 and were defined as > 20 grouped cells.|day 14|baseline marrow samples were available only 5 participants||number of colonies per 50000 cell plated||Standard Deviation|Mean
162407|NCT00262873|Secondary|Average Percentage of Light Density Cells in Apoptosis|The CD34+ fraction of light density marrow obtained from patients at baseline and while receiving bortezomib were assessed through measurement of Annexin V (assay obtained form R&D Systems) and by flow cytometry analysis.|day 14|marrow samples were not available on all participants at baseline||percentage of apoptotic cells||Standard Deviation|Mean
162408|NCT00262873|Secondary|Vascular Endothelial Growth Factor (VEGF) Levels in Serum|VEGF levels were measured by ELISA (R&DSystems) in serum from participants exposed to bortezomib. Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial.|day 14|data was only available on 5 participants||pg/ml||Standard Deviation|Mean
162409|NCT00262873|Secondary|Interleukin 6 Levels in Serum|"interleukin-6 levels were measured by enzyme-linked immunosorbant assay ELISA in serum from participants exposed to bortezomib.~Levels were measured at Day 0 and Day 14 of cycle 1 of the clinical trial."|day 14|data was only available on 5 participants||pg/ml||Standard Deviation|Mean
162412|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 2)|Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline and 1-2 weeks after cycle 2, day 11|Samples were not collected on one patient, so only 17 patients were analyzed.||percentage of change in proteosome activ||Full Range|Median
162413|NCT00262860|Secondary|Change in Proteasome Activity Compared to Baseline (Cycle 1)|Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.|baseline to 2 hours|Samples were not collected on one patient, so only 17 patients were analyzed.||Percentage of change in proteosome activ||Full Range|Median
162414|NCT00262860|Primary|Response Rate After 2 Courses of Therapy|Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG–PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG–PET images) to below three on posttreatment FDG–PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).|21 Days/course for up to 2 courses|||participants|||Number
162415|NCT00262847|Secondary|Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)|Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.|At baseline, 9, 18, 36, 60, and 84 weeks|Number of valid QOL assessments do not total number of patients randomized in study.||units on a scale||Standard Deviation|Least Squares Mean
162416|NCT00262847|Secondary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Up to 5 years||||||
162417|NCT00262847|Secondary|Overall Survival|Median overall survival (OS)|From study entry to death or last contact, up to 6 years|||months||95% Confidence Interval|Median
162418|NCT00262847|Primary|Progression-free Survival|Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).|From study entry until first disease progression, death or date of last contact, up to 6 years|||months||95% Confidence Interval|Median
162419|NCT00262834|Primary|Change in Tissue Apoptosis After 3 Days of Treatment|Change in cleaved caspase-3 (a marker of tissue apoptosis) by IHC compared to baseline in the treated (19 evaluable samples) or untreated patients (12 evaluable samples) were analyzed between groups. Cleaved caspase-3 is a protein in cells involved in apoptosis (cell death).|Baseline and after 3 day of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for cleaved caspase-3 by IHC were available from 19 (71%) treated and from 12 (48%) controls.||percentage of change|Participants|Full Range|Mean
162420|NCT00262834|Secondary|Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment||Baseline and after 3 day of Vorinostat||||||
162421|NCT00262834|Secondary|Change in Tissue Histone Acetylation After 3 Days of Treatment||Baseline and after 3 day of Vorinostat||||||
162422|NCT00262834|Primary|Change in Tissue Proliferation After 3 Days of Treatment|Change in Ki-67 (a marker of tissue proliferation) by IHC compared to baseline in the treated (22 evaluable samples) or untreated patients (15 evaluable samples) were analyzed between groups. Ki-67 is a protein in cells that increases as cellsprepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. The more positive cells there are, the more quickly they are dividing and forming new cells.|After 3 days of vorinostat|Matched samples (ie, diagnostic biopsy and surgical tissues) for Ki-67 by IHC were available from 22 (92%) treated and from 15 (60%) controls.||percentage of change|Participants|Full Range|Mean
162423|NCT00262834|Primary|Number of Participants With Adverse Events|Participants were evaluated for adverse events due to vorinostat to assess if it was safe to give the drug prior to surgery. 17 of 25 participants who received vorinostat experienced at least 1 adverse event believed to be related to the study drug; no adverse events were severe, and the treatment was considered safe.|After 3 days of vorinostat|Participants who received at least one dose of vorinostat.||participants|||Number
162424|NCT00262743|Other Pre-specified|24 Month Treatment Free Survival Rate|Percentage of participants who were alive and treatment (for progressive CLL) free at 24 months. The 24 month treatment free survival, with 95% CI, was estimated using the Kaplan-Meier method.|24 months (from registration)|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||percentage of participants||95% Confidence Interval|Number
162425|NCT00262743|Secondary|Number of Participants With a Confirmed Complete Response (CR)|A confirmed complete response is a CR which is reported on 2 consecutive cycles at least 4 weeks apart. CR is defined in Primary Outcome Measure #1.|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||participants|||Number
162426|NCT00262743|Primary|Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart|Bio-R: A reduction in the absolute lymphocyte count (ALC) of more than 20% from the pretreatment level for at least 2 months or a >= 30% reduction in all palpable lymphadenopathy without meeting the NCIWG criteria for PR was required|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||participants|||Number
162427|NCT00262743|Primary|Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart|"National Cancer Institute working group criteria (NCIWG) was used to assess response.~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|6 months|Phase II participants who satisfied all eligibility criteria, signed the consent form and started therapy were evaluated for this endpoint.||participants|||Number
162428|NCT00262730|Primary|Survival|survival time is defined from time of histological diagnosis to death occurrence.|30 months|all patients who were treated were analyzed (intent to treat)||months||95% Confidence Interval|Mean
162429|NCT00262639|Secondary|Regional Brain Activity on fMRI||Week 2||||||
162430|NCT00262639|Secondary|Acoustic Startle Response||Day 1, Day 3, Week 1||||||
162431|NCT00262639|Secondary|Sleep||Weeks 1 to 6, 10 and 14||||||
162432|NCT00262639|Primary|Percent Days Abstinent|percent days abstinent during treatment|Weeks 1 to 6, 10 and 14|||percent days||Standard Deviation|Mean
162433|NCT00262639|Primary|Alcohol Withdrawal Scores (CIWAar)||Day 1 Day 2 Week 1||||||
162434|NCT00262639|Primary|Percent Subjects Completely Abstinent|percent of subects completely abstinent during the study|16 week trial|||percent of participants|||Number
162435|NCT00262600|Secondary|Abnormal Liver Function Test|Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN|36 months|Safety set - all subjects who were randomized and received at least 1 dose of study drug||participants|||Number
162436|NCT00262600|Secondary|Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)|Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)]|||Number
162437|NCT00262600|Secondary|Bleeding Events (Major and Minor)|"Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25~Major bleeds are adjudicated, whereas minor bleeds are investigator reported."|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
162438|NCT00262600|Secondary|Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death|Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
162439|NCT00262600|Secondary|Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death|Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
162440|NCT00262600|Primary|Yearly Event Rate for Composite Endpoint of Stroke/SEE|Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25|36 months|Randomized set - The randomized set includes all randomized subjects in the treatment groups to which they were randomized, regardless of whether the subjects took randomized study medication or not.||yearly event rate (percentage)|||Number
162441|NCT00262522|Secondary|Mean Change From Baseline to Week 96 in CD4+ T Cell Counts||Week 96 (End of Study)|All randomized subjects who received at least 1 dose of study drug and who had CD4+ T cell counts available at both the Baseline Visit and Week 96.||cells/microliter||Standard Error|Mean
162442|NCT00262522|Secondary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96||Week 96 (End of Study)|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.||Percentage of Subjects|||Number
162443|NCT00262522|Primary|Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48||Week 48|Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.||Percentage of Subjects|||Number
162444|NCT00262522|Primary|Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks||Week 8|All randomized subjects who received at least 1 dose of study drug.||Percentage of Subjects|||Number
162445|NCT00262509|Primary|Time to Exit Building|Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.|30 minutes total, 15 minutes for each of two timed trials|Total number of participants completing study||seconds|Participants|Standard Deviation|Mean
162446|NCT00262314|Primary|Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses|Outcomes are presented separately above apart from adverse events which are presented in the adverse event section|up to 5 years||||||
162447|NCT00262314|Primary|Clinical Relapses (Annual Follow-Up Phase)|Number of clinical relapses reported during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||number of relapses|||Number
162448|NCT00262314|Primary|Clinical Relapses (Treatment Phase)|Number of clinical relapses reported during the treatment phase of the trial|up to 36 months|||number of relapses|||Number
162452|NCT00262314|Primary|IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)|Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase|up to 36 months|||participants|||Number
162453|NCT00262314|Primary|Serious Infections (Annual Follow-Up Phase)|Number of serious infections during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||number of infections|||Number
162454|NCT00262314|Primary|Serious Infections (Treatment Phase)|Number of serious infections during the treatment phase of the trial|up to 36 months|||number of infections|||Number
162455|NCT00262314|Primary|Left Ventricular Ejection Fraction (Annual Follow-Up Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||participants|||Number
162456|NCT00262314|Primary|Left Ventricular Ejection Fraction (Treatment Phase)|Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial|up to 36 months|||participants|||Number
162457|NCT00262314|Primary|Congestive Heart Failure (Annual Follow-Up Phase)|Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial|up to 5 years|participants with annual follow up data||participants|||Number
162458|NCT00262314|Primary|Congestive Heart Failure (Treatment Phase)|Number of patients experiencing congestive heart failure during the treatment phase of the trial|up to 36 months|||participants|||Number
162459|NCT00262301|Secondary|Time to Minimal Symptoms|"the time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment time-points were: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to minimal symptoms has been calculated by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of study drug administration."||minutes||Full Range|Median
162460|NCT00262301|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms has been assessed by using a patient-reported visual analogue scale (VAS) ranging from 0 mm (no symptoms at all) to 100 mm (extremely disabling). Time to beginning of relief of symptoms at the location that showed first VAS score decrease of at least 20 mm from baseline score (t= 0 min) to the next assessment time-point). Assessment time-points were taken on pre-scheduled time-points after drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to beginning of relief has been calculated as median time, by using the exact time-points on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."||minutes||Full Range|Median
162461|NCT00262223|Secondary|Global Psychiatric Severity||1 year||||||
162462|NCT00262223|Secondary|Retention Rates in Alcohol Treatment||1 year||||||
162463|NCT00262223|Secondary|Trajectory and Trends of Changes in Substance Use and PTSD Symptoms||1 year||||||
162464|NCT00262223|Secondary|Alcohol Subtypes Based on Pre-morbid Risk Factors||1 year||||||
162465|NCT00262223|Primary|PTSD Symptom Severity / Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item, semi-structured interview of PTSD symptoms. Range of scores is 0-136. Five rationally derived severity score ranges for interpreting CAPS total score have been proposed: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology (Weathers et. al., 2001). A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change (Weathers et. al., 2001).|Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up|||units on a scale||Standard Deviation|Mean
162466|NCT00262223|Primary|Heavy Drinking Days||Baseline, End-of-treatment, 6-month follow-up and 12-month follow-up|||Days||Standard Deviation|Mean
162467|NCT00262119|Primary|Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years|The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.|2 years|Analysis was intention to treat therefore all randomized patients were considered in the analyses||percentage of participants||95% Confidence Interval|Number
162468|NCT00262119|Secondary|Frequency, Type, and Associated Cost of Health Care Utilization and Utility||2 years||||||
162469|NCT00262119|Secondary|Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients||2 years||||||
162470|NCT00262119|Secondary|Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay||2 years||||||
162471|NCT00262119|Secondary|Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation||2 years||||||
162472|NCT00262119|Secondary|Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism||2 years||||||
162473|NCT00262119|Secondary|Development of Atrioventricular (AV) Block and Pacemaker Dependency||2 years||||||
162474|NCT00262119|Secondary|Adverse Events||2 years||||||
162475|NCT00262119|Secondary|Persistent Atrial Fibrillation (AF)||2 years||||||
162476|NCT00262119|Secondary|Atrial Fibrillation Burden||2 years||||||
162477|NCT00262119|Secondary|Any Hospitalization||2 years||||||
162478|NCT00262119|Secondary|Cardiovascular Death||2 years||||||
162479|NCT00262119|Secondary|Cumulative Percentage of Ventricular Pacing||2 years||||||
162480|NCT00262119|Secondary|Heart Failure Medications||2 years||||||
162481|NCT00262119|Secondary|Subjects' Symptoms||2 years||||||
162482|NCT00262119|Secondary|Burden of Composite Clinical Endpoint||2 years||||||
162483|NCT00262119|Secondary|Incidence of Cardiovascular Hospitalizations at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years|2 years|Analysis was intention to treat therefore all randomized patients were analysed||percentage of participants||95% Confidence Interval|Number
162484|NCT00262119|Secondary|Incidence of Permanent Atrial Fibrillation at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were analysed||percentage of participants||95% Confidence Interval|Number
162485|NCT00262119|Secondary|Death for All Causes at 2 Years|Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years|2 years|The analysis was intention to treat therefore all randomized patients were included in the analysis||percentage of participants||95% Confidence Interval|Number
162486|NCT00262080|Other Pre-specified|Time to Significant Improvement in Overall Response Over Multiple Treatment Episodes|The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline (ie,immediately before treatment) using the following 5-category scale from significant improvement (Score = 100)to significant worsening (Score = -100)|4 hours post-dose (REPEAT-DOSING PART)|Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the interquartile range (IQR) was not reached by 4 hours for most episodes.||participants|||Number
162487|NCT00262080|Secondary|Time to Significant Improvement in Overall Response|"The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline. Patients were asked overall how are you feeling compared to how they felt before study drug. Answer options were a lot worse, a little worse, same, a little better or a lot better or resolved. Significant improvement was the first time that the patient responded to the assessment as a little better or resolved."|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated. Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the median time for placebo was not reached by 4 hours.||participant|||Number
162488|NCT00262080|Other Pre-specified|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose Over Multiple Treatment Episodes|The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.||units on a scale||Standard Deviation|Mean
162489|NCT00262080|Other Pre-specified|Treatment Outcome Score at 4 Hours Post-Dose Over Multiple Treatment Episodes|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (REPEAT-DOSING PART)|Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention.||units on a scale||Standard Deviation|Mean
162490|NCT00262080|Other Pre-specified|Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART)|Patient-reported severity of symptom complexes at baseline, by symptom complex and treatment group. Patients were to have at least one symptom complex that was moderate or severe. Patients could present with multiple symptom complexes, some of which could be mild. Mild=noticeable but do not impact daily living activities; Moderate=treatment or intervention is highly desirable and activities of daily living are impacted; Severe=require treatment or intervention due to inability to perform activities of daily living. The results are for number of patients with symptom complexes including mild, moderate and severe, provided the patients have at least one symptom complex that was moderate or severe|Baseline|||participants|||Number
162491|NCT00262080|Secondary|Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose|Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement (minimally important difference) was indicated by a reduction in the score of 0.30 or more.|baseline, 4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same center were administered treatment opposite to their randomized treatment assignments. Data were analyzed based on their actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 0.0; worst possible score = 3.0.||units on a scale||Standard Deviation|Mean
162501|NCT00262041|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.|12 months after vaccination|Analysis was done on PP population.||Percentages Of Subjects||95% Confidence Interval|Number
162736|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
162492|NCT00262080|Primary|Treatment Outcome Score at 4 Hours Post-Dose|Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100] to significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher.|4 hours post-dose (DOUBLE-BLIND PART)|ITT as treated: two patients randomized on the same day at the same study center were administered treatment opposite to their randomized treatment assignment. Data were analyzed based on actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 100; worst possible score = -100.||units on a scale||Standard Deviation|Mean
162493|NCT00262067|Secondary|Progression-free Survival (PFS) as Determined by the Independent Review Committee Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the Independent Review Committee using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
162494|NCT00262067|Secondary|1-year Survival|"1-year survival was defined as the percentage of patients who were alive 1 year after randomization.~The percentage of patients alive at 1 year was determined using Kaplan-Meier analyses and the 95% confidence intervals were computed using the Brookmeyer-Crowley method."|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Percentage of participants||95% Confidence Interval|Number
162495|NCT00262067|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
162496|NCT00262067|Secondary|Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from the first tumor assessment that led to a determination of an objective response to the time of disease progression or death due to any cause, whichever occurred first.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline and who had an objective response were included in the analysis.||Months||95% Confidence Interval|Median
162497|NCT00262067|Secondary|Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment. Only patients with measurable disease at baseline were included in the analysis.||Percentage of participants||95% Confidence Interval|Number
162498|NCT00262067|Primary|Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months)|Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.||Months||95% Confidence Interval|Median
162499|NCT00262041|Secondary|Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination|Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.|Day 1 to Day 7|Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data.||Subjects|||Number
162500|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.|12 months after vaccination|Analysis was done on PP population.||Titers||95% Confidence Interval|Geometric Mean
162502|NCT00262041|Secondary|hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.|1 month after vaccination|Analysis was done on per-protocol population.||Titers||95% Confidence Interval|Geometric Mean
162503|NCT00262041|Primary|Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine|Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y|1 month after vaccination|Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation.||Percentages Of Subjects||95% Confidence Interval|Number
162504|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1- Day 360 (Throughout the study)|Analysis was done on safety population.||Subjects|||Number
162505|NCT00262028|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1- Day 360 (throughout the study)|Analysis was done on safety population.||Subjects|||Number
162506|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.|Day 1 to 7 post vaccination|Analysis was done on safety population.||Subjects|||Number
162507|NCT00262028|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years|Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.|Day 1 to 7 post vaccination|Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.||Subjects|||Number
162508|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.||Titer||95% Confidence Interval|Geometric Mean
162509|NCT00262028|Secondary|Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|12 months post vaccination (Day 360)|Analysis was done on per protocol population.||Subjects|||Number
162510|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Titer||95% Confidence Interval|Geometric Mean
162511|NCT00262028|Secondary|hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Titer||95% Confidence Interval|Geometric Mean
162512|NCT00262028|Secondary|hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine|hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Titers||95% Confidence Interval|Geometric Mean
162513|NCT00262028|Secondary|Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine|Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population.||Percentages of subjects||95% Confidence Interval|Number
162514|NCT00262028|Secondary|Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).||Percentages of subjects||95% Confidence Interval|Number
162515|NCT00262028|Primary|Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine|Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.|1 month post vaccination (Day 29)|Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.||Subjects|||Number
162516|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age|The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.|7 days after vaccination at 12 months of age|"Analysis was done on safety dataset n population."||subjects|||Number
162517|NCT00262002|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-|Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.|7 days after each vaccination|"Analysis was done on safety dataset n population - subjects who received at least one study dose and had Post baseline safety data."||subjects|||Number
162518|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)|The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population after second vaccination."||percentages of subjects||95% Confidence Interval|Number
162519|NCT00262002|Secondary|ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B|To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||titers||95% Confidence Interval|Geometric Mean
162520|NCT00262002|Secondary|Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
162521|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine|The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.|at 12 months of age and 1 month after PS challenge|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
162522|NCT00262002|Secondary|Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine|The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.|Baseline and 1 month after the 2 or 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
162523|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
162524|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine|The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.|Before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
162525|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
162526|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.|before challenge at 12 months of age and 1 month after PS challenge.|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
162737|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
162527|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||Titers||95% Confidence Interval|Geometric Mean
162528|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine|The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.|at 12 months of age|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
162529|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.|The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
162530|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine|The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.|at 12 months of age|"The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
162531|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||titers||95% Confidence Interval|Geometric Mean
162532|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine|Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.|at 12 months of age and 1 month after booster vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response."||percentages of subjects||95% Confidence Interval|Number
162533|NCT00262002|Secondary|Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population"||titers||95% Confidence Interval|Geometric Mean
162534|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines|Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.|Baseline and 1 month after second vaccination|"The analysis was performed on the MenACWY per-protocol (PP) n population."||percentages of subjects||95% Confidence Interval|Number
162535|NCT00262002|Secondary|Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||titers||95% Confidence Interval|Geometric Mean
162536|NCT00262002|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine|Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.|Baseline and 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
162537|NCT00262002|Primary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine|Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.|Baseline and at 1 month after the 3 dose primary vaccination series|"The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination."||percentages of subjects||95% Confidence Interval|Number
162538|NCT00261950|Secondary|Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52||Baseline to week 52|Enrolled subjects with TRAP at week 52||percent change||Standard Error|Mean
162539|NCT00261950|Secondary|Percent Change From Baseline in Osteocalcin (OC) at Week 52||Baseline to week 52|Enrolled subjects with osteocalcin (OC) at week 52||Percent change||Standard Error|Mean
162540|NCT00261950|Secondary|Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter|"Eroded Perimeter/Bone Perimeter was calculated as Eroded Perimeter/Bone Perimeter * 100"|Baseline to week 52|Enrolled subjects with eroded perimeter/bone perimeter at week 52||percentage of bone perimeter||Standard Error|Mean
162541|NCT00261950|Secondary|Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area|Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)|Baseline to week 52|Enrolled subjects with Fibrosis Area/Tissue Area at week 52||participants|||Number
162542|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)|"Osteoclast Perimeter was calculated as Osteoclast Perimeter/Eroded Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoclast Perimeter at week 52||percentage of eroded perimeter||Standard Error|Mean
162543|NCT00261950|Secondary|Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)|"Osteoblast Perimeter was calculated as Osteoblast Perimeter/Osteoid Perimeter * 100"|Baseline to week 52|Enrolled subjects with Osteoblast Perimeter at week 52||percentage of osteoid perimeter||Standard Error|Mean
162544|NCT00261950|Primary|Change From Baseline to End of Study in Bone Formation Rate (BFR)||Baseline to week 52|Enrolled subjects with bone biopsy at week 52||μm^2/mm^2/day||Standard Error|Mean
162545|NCT00261950|Secondary|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with PTH during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
162546|NCT00261950|Secondary|Percent Change From Baseline in N – Telopeptide (NTx) at Week 52||Baseline to week 52|Enrolled subjects with NTx at week 52||percent change||Standard Error|Mean
162547|NCT00261950|Secondary|Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52||Baseline to week 52|Enrolled subjects with BALP at week 52||percent change||Standard Error|Mean
162548|NCT00261950|Secondary|Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with Ca x P during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
162549|NCT00261950|Secondary|Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum phosphorus during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
162550|NCT00261950|Secondary|Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)||Baseline to weeks 40-52|Enrolled subjects with serum calcium during the Efficacy Assessment Phase (EAP)||percent change||Standard Error|Mean
162551|NCT00261846|Secondary|Number of Participants With Change From Baseline in Physical Examinations and Vital Signs|Number of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, respiratory rate of <10 or >50 breaths/minute and criteria for PCI change in physical examination: >=10% increase or decrease of body weight (Wt) in kilogram (kg).|Baseline up to end of treatment (Year 5)|Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||participants|||Number
162552|NCT00261846|Secondary|Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group Performance Status (ECOG-PS)|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.|Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Safety population included all participants who receive at least one dose of study medication.||participants|||Number
162553|NCT00261846|Secondary|Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported.|Baseline up to end of treatment (Year 5)|Safety population included all participants who receive at least one dose of study medication.||participants|||Number
162554|NCT00261846|Secondary|Number of Participants With Change From Baseline in Findings of Chest X-ray||Baseline, Week 8, and end of treatment|Data for this outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.|||||
162555|NCT00261846|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings|Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval >=220 msec and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) >500 msec or increase of >60 msec; heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit|Safety population included all participants who receive at least one dose of study medication. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure.||participants|||Number
162556|NCT00261846|Secondary|Number of Participants With Change From Baseline in Laboratory Tests Results|Laboratory values included urinalysis, complete blood count (CBC), prothrombin time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Potentially clinically important (PCI) changes in laboratory assessments were reported. Any laboratory value that was identified as clinically significant was reported as an AE. PCI laboratory values were defined as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher.|Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Safety population included all participants who receive at least one dose of study medication.||participants|||Number
162557|NCT00261846|Secondary|Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. PCI-AEs included hepatotoxicity, gastrointestinal toxicity: diarrhea, nausea, vomiting, hypersensitivity reactions, rash, edema, effusion, myelosuppression, hemorrhage, infection, cardiac events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates.|Baseline up to follow up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.||days||Full Range|Median
162558|NCT00261846|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to follow up visit (30 days after last dose of study treatment)|Safety population included all participants who receive at least one dose of study medication.||percentage of participants|||Number
162559|NCT00261846|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2|OHR included CHR, no evidence of leukemia (NEL), minor hematologic response (MiHR) or return to chronic phase (RCP), participants had to meet at least 1 of this criterion. Criteria for RCP: disappearance of features defining AP/BP, but still in CP and persistence of clonal evolution. Criteria for MiHR: <15% blasts in blood and BM, <30% blasts+promyelocytes in blood and BM, <20% basophils in blood, no extramedullary disease other than liver/spleen. Criteria for CHR and NEL: <20% basophils in blood, no extramedullary involvement including liver/spleen, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, <5% (NEL) and <=5% (CHR) marrow blasts, 0.5*10^9 <= Absolute neutrophil count (ANC) <1.0*10^9/L (NEL) and ANC>=1.0*10^9/L (CHR), 20*10^9 <=platelets<100 *10^9/L (NEL) and platelets>=100 but <450x10^9/L (CHR), white blood cells <=institutional upper limit of the normal range.|Week 48|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.||percentage of participants||95% Confidence Interval|Number
162560|NCT00261846|Secondary|Percentage of Participants With Complete Hematologic Response (CHR) in Advanced Leukemia Population - Part 2|Hematologic response was considered to be achieved if participants met all of the following criteria of CHR: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >= 1.0*10^9 per liter (/L), platelets >=100*10^9/L but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.|Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.||percentage of participants||95% Confidence Interval|Number
162561|NCT00261846|Secondary|Overall Survival (OS) Rate - Part 2|OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death, censored at the participant's last contact date.|Baseline up to Year 2|All-treated population included all enrolled participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
162562|NCT00261846|Secondary|Progression Free Survival (PFS) Rate - Part 2|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to treatment discontinuation due to disease progression as assessed by the investigator. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs).|Baseline up to Year 1, Year 2|All-treated population included all enrolled participants who received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
162563|NCT00261846|Secondary|Time to Achieve Complete Hematologic Response (CHR) - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant. Hematologic response was considered to be achieved if participants met all of the following criteria of CHR: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >= 1.0*10^9 per liter (/L), platelets >=100*10^9/L but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.|Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.||weeks||95% Confidence Interval|Median
162564|NCT00261846|Secondary|Duration of Complete Hematologic Response (CHR) - Part 2|The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7. CHR response was considered to be achieved if participants met all of the following criteria: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >=1.0*10^9 per liter (/L), platelets >=100 but <450*10^9/L unless related to therapy, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.|Baseline, Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Subgroup of participants from evaluable population who had confirmed complete hematologic response.||weeks||95% Confidence Interval|Median
162565|NCT00261846|Secondary|Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2|"Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.~Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last cytogenetic assessment date of a participants. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM."|Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.||weeks||95% Confidence Interval|Median
162566|NCT00261846|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2|"Duration of MCyR was defined as the interval from the date of the earliest demonstration of a response, until the earliest date of loss of that response.~Duration of response in weeks = (date of confirmed loss of first attained response minus date of first attained response)/7 days. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM."|Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Subgroup of participants from evaluable population who had confirmed major cytogenic response.||weeks||95% Confidence Interval|Median
162567|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML and Chronic Phase Third-line CML - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from Bone Marrow (BM) sample. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0% Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM.|Baseline, Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.||percentage of participants||95% Confidence Interval|Number
162568|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line Imatinib Intolerant CML and Chronic Phase Third-line CML Population - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from Bone Marrow (BM) sample. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells in metaphase in BM and PCyR was achieved when 1 to 35% Ph+ cells in metaphase in BM.|Week 24 for second line, Baseline through Week 24 for third line|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.||percentage of participants||90% Confidence Interval|Number
162569|NCT00261846|Secondary|Percent Change From Baseline in Phosphorylated Cancer-testis 10 (CT10) Regulator of Kinase Like (p-CrkL) Protein Level in Blood at Day 1, 8 and 15 - Part 1|CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells by using FACS flow cytometry. Percent change in p-CrkL protein at different time points give measure of phosphorylation inhibition from baseline.|6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' signifies number of participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time points for each arm group respectively.||percent change||Standard Deviation|Mean
162570|NCT00261846|Secondary|Phosphorylated Cancer-Testis 10 (CT10) Regulator of Kinase Like (p-CrkL) Protein Level in Blood at Baseline – Part 1|CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells by using fluorescent activated cell sorter (FACS) flow cytometry. Amount of CrkL protein phosphorylated (in moles) per 100 blood cells was reported.|0 (pre-dose) on Day 1 (Baseline)|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||moles/100 blood cells||Standard Deviation|Mean
162571|NCT00261846|Secondary|Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1|bcr-Abl is a protein resulting from the transcription of the Philadelphia chromosome following 9:22 chromosomal translocation, and phosphorylation inhibition of which correlates with inhibition of tumor cell growth.|Baseline, Week 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Data was not summarized since inadequate data included the issue that molecular transcript analyses could not be performed, because of potential sample quality issues due to time required to transport the specimens from the few investigational sites to the central laboratory.|||||
162572|NCT00261846|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Baseline, thereafter assessed every 12 weeks up to 2 years then every 24 weeks up to Year 5|Cytogenetic evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline cytogenetic assessment.||percentage of participants||95% Confidence Interval|Number
162573|NCT00261846|Primary|Population Pharmacokinetics - Part 2|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|0 (pre-dose), 2, 4, 6 hours on Day 1, Day 21, 20-23 hours post-dose on Day 21, 0 (pre-dose) hours on Day 84, 168, 252||||||
162574|NCT00261846|Primary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.||percentage of participants||90% Confidence Interval|Number
162617|NCT00261495|Secondary|Amount of add-on Pain Medication|Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24.|24 weeks|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||mg||Standard Deviation|Mean
162575|NCT00261846|Primary|Accumulation Ratio (R)|R=accumulation ratio (AUCss on Day 15/AUC[0-24] on Day 1)|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ratio||Standard Deviation|Mean
162576|NCT00261846|Primary|Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral clearance over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||L/hr||Standard Deviation|Mean
162577|NCT00261846|Primary|Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
162578|NCT00261846|Primary|Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life over 24 hours at steady state (ss), on Day 15 was calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||hrs||Standard Deviation|Mean
162579|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1|Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||hrs||Full Range|Median
162580|NCT00261846|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1|Maximum plasma concentration over 24 hours at steady state (ss), on Day 15.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
162581|NCT00261846|Primary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||liter||Standard Deviation|Mean
162582|NCT00261846|Primary|Apparent Oral Clearance (CL/F) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||liter per hour (L/hr)||Standard Deviation|Mean
162583|NCT00261846|Primary|Area Under the Concentration-Time Curve (AUC) - Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. There were fewer participants evaluable for AUC values than participants evaluable for AUClast because terminal half-life of some participants was not accurately estimated and therefore AUC in these participants was not calculated.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||ng*hr/mL||Standard Deviation|Mean
162584|NCT00261846|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.||ng*hr/mL||Standard Deviation|Mean
162585|NCT00261846|Primary|Plasma Decay Half-Life (t1/2) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.||hrs||Standard Deviation|Mean
162586|NCT00261846|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment.||hours (hrs)||Full Range|Median
162587|NCT00261846|Primary|Maximum Observed Plasma Concentration (Cmax) - Part 1||0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1|Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
162588|NCT00261846|Primary|Maximum Tolerated Dose (MTD)|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication.||mg|||Number
162589|NCT00261846|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Part 1 Baseline up to Day 28|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
162590|NCT00261833|Other Pre-specified|Baseline Lung Density at Total Lung Capacity (TLC) and Forced Residual Capacity (FRC)||Baseline|||g/L||Standard Deviation|Mean
162591|NCT00261833|Secondary|Severity of Pulmonary Exacerbations|"Defined as the number of participants requiring 1) antibiotic treatment for exacerbations, and 2) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.~Antibiotic treatment usage was reported by quarterly interval."|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||participants|||Number
162592|NCT00261833|Secondary|Duration of Pulmonary Exacerbations Relative to Treatment Duration|Defined as the percentage of total treatment duration across participants for 1) exacerbations overall, 2) antibiotic treatment for exacerbations, and 3) hospitalization for exacerbations. Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||percentage of total treatment duration||Standard Deviation|Mean
162593|NCT00261833|Secondary|Percent Change in DLCO|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
162594|NCT00261833|Secondary|Percent Change in FEV1 Divided by Forced Vital Capacity|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
162595|NCT00261833|Secondary|Percent Change in Percent Predicted FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
162596|NCT00261833|Secondary|Frequency and Intensity of Adverse Events (AEs)|Number of participants with at least one AE, and the number of participants with mild, moderate or severe AEs. AE intensity was defined as mild (does not interfere with routine activities), moderate (interferes with routine activities), or severe (impossible to perform routine activities).|Over a 2-year period|All participants receiving at least 1 infusion of either Zemaira® or placebo.||participants|||Number
162597|NCT00261833|Secondary|Change in Patient-reported Symptoms|Patient-reported symptoms were measured using the symptoms score component of the St George's Respiratory Questionnaire (SGRQ). SGRQ scores range from 0 to 100, with higher scores indicating more limitations and negative values for change indicating improvement. Change from baseline to end of treatment (2 years) in SGRQ was analysed using an ANCOVA.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||units on a scale||Standard Error|Least Squares Mean
162598|NCT00261833|Secondary|Change in Exercise Capacity|Exercise capacity was measured as distance walked, using the incremental shuttle walk test. Change from baseline to end of treatment (2 years) in exercise capacity was analysed using an analysis of covariance (ANCOVA).|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||metre||Standard Error|Least Squares Mean
162599|NCT00261833|Secondary|Change in Lung Density|Change from baseline to Month 24 as measured by centralized, standardized CT lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least 1 endpoint assessment available.||g/L||Standard Error|Least Squares Mean
162600|NCT00261833|Secondary|Time to First Pulmonary Exacerbation|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||Years||95% Confidence Interval|Median
162601|NCT00261833|Secondary|Percent Change in FEV1|Percent change from baseline to Month 24.|From baseline to 2 years|All participants with A1-PI deficiency who were included in the study, randomized, and had a baseline and at least one endpoint assessment available.||percent change||Standard Error|Least Squares Mean
162616|NCT00261495|Secondary|Mode and Convenience of Drug Intake.|Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162602|NCT00261833|Secondary|Annual Rate of Pulmonary Exacerbations|Primary diagnostic criteria for exacerbations were increased dyspnea, increased sputum volume, and increased sputum purulence. Supporting diagnostic criteria were upper respiratory tract infection, fever without other apparent cause, increased wheezing, and increased cough. For diagnosis, participants had to meet 2 of the 3 primary criteria or 1 primary criterion and 1 supporting criterion. The annual rate was based on the total number of exacerbations and the total number of participant study days for all participants in the specified analysis population and adjusted to 365.25 days.|Over a 2-year period|All participants with A1-PI deficiency who were included in the study and randomized.||exacerbations per participant year||95% Confidence Interval|Number
162603|NCT00261833|Primary|Annual Rate of Change in Lung Density|As measured by centralized, standardized computer tomographic (CT) lung densitometry. CT scans were acquired at 2 inspiration states: TLC (ie, full inspiration) and FRC (ie, full expiration). Results were adjusted for total lung volume and are presented as point estimates for the average rate of decline in each treatment group.|Over a 2-year period|All randomized participants with at least 1 valid CT scan.||g/L per year||Standard Error|Least Squares Mean
162604|NCT00261716|Secondary|Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)|Employment status at each major follow-up assessment period and overall adjustment as rated on the Social Adjustment Scale II (Schooler, N., G. Hogarty, and M. Weissman, Social Adjustment Scale II (SAS-II), in Resource Materials for Community Mental Health Program Evaluations, W.A. Hargreaves, C.C. Atkisson, and J.E. Sorenson, Editors. 1979, NIMH: Rockville, MD. p. 290-303), on a 1 (excellent adjustment ) to 7 (severe maladjustment) scale.|6, 12, and 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=25 analyzed at 6 months; total n= 16 analyzed at 12 months; total n = 17 analyzed at 18 months||units on a scale||Standard Deviation|Mean
162605|NCT00261716|Secondary|Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)|Employment status at each major follow-up assessment period and self-reported Life Satisfaction (range from 1 (terrible) to 7 (delighted)) on the Quality of Life Scale (Lehman A, Kernan E, and Postrado L, Toolkit for Evaluating Quality of Life for Persons with Severe Mental Illness. 1995, Baltimore, MD: The Evaluation Center at HSRI).|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=26 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 17 analyzed at 18 months||units on a scale||Standard Deviation|Mean
162606|NCT00261716|Secondary|Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale|Employment status at each major follow-up assessment period and psychiatric symptomatology as reflected in the Total Brief Psychiatric Rating Scale Score (Ventura J, et al., Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Research, 1998. 79(2): p. 163-173) with scale range from 24 to 168, with higher scores indicating greater symptomatology|6,12, 18 months|Number of individuals working within one month of assessment point varies by follow up point; total n=38 at baseline; total n=23 analyzed at 6 months; total n= 19 analyzed at 12 months; total n = 16 analyzed at 18 months||units on a scale||Standard Deviation|Mean
162607|NCT00261716|Secondary|Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program|Number of participants who obtained a second or third job if lost his/her first job but still had at least 2 months in the study|18 months of the study|Includes only participants who obtained at least one job and had at least 2 months left if they lost/left that job; 2 individuals in each condition held the same job for almost the whole program and thus could not contribute data here||participants|||Number
162608|NCT00261716|Primary|Average Number of Hours Worked Per Week For Those Who Worked|Average number of hours worked per week among participants who obtained a job|18 months of study|Only included hours worked for participants who obtained a job (n=19 in the entire study)||hours/worked per week||Standard Deviation|Mean
162609|NCT00261716|Primary|Average Number of Days Worked|Average number of total days each participant worked in the study|18 months of study|||days||Standard Deviation|Mean
162610|NCT00261716|Primary|Obtained Employment|Number of participants who obtained a competitive job|18 months of study|||participants|||Number
162611|NCT00261495|Primary|Equi-analgesic Dose at Steady State (ITT Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||mg per day||Standard Deviation|Mean
162612|NCT00261495|Primary|Equi-analgesic Dose at Steady-state (PP Population)|Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.|week 4 to week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)||mg per day||Standard Deviation|Mean
162613|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||mg per day||Standard Deviation|Mean
162614|NCT00261495|Primary|Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)|If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.|week 24|PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)||mg per day||Standard Deviation|Mean
162615|NCT00261495|Secondary|Resource Utilization of Pain Management|Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Additional visits||Standard Deviation|Mean
162618|NCT00261495|Secondary|Number of Days With add-on Pain Medication|Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Days||Standard Deviation|Mean
162619|NCT00261495|Secondary|Number of Drop-outs|Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52.|baseline to week 24 (core); week 24 to week 52 (extension)|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162620|NCT00261495|Secondary|Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)|Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24.|weeks 4 and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162621|NCT00261495|Secondary|Change in Dose of Study Treatment|Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162622|NCT00261495|Secondary|Clinical Global Assessment of Efficacy|Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52.|weeks 4, 24, and 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162623|NCT00261495|Secondary|Change From Baseline in QoL at Week 52|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162624|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162625|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162626|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162627|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 24"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162628|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162629|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162630|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162631|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162711|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
162632|NCT00261495|Secondary|"Change From Baseline in QoL Bodily Pain at Week 24"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162633|NCT00261495|Secondary|"Change From Baseline in QoL Vitality at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162634|NCT00261495|Secondary|"Change From Baseline in QoL Social Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162635|NCT00261495|Secondary|"Change From Baseline in QoL Role Physical at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162636|NCT00261495|Secondary|"Change From Baseline in QoL Role Emotional at Week 4"|"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162637|NCT00261495|Secondary|"Change From Baseline in QoL Physical Functioning at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162638|NCT00261495|Secondary|"Change From Baseline in QoL Mental Health at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162639|NCT00261495|Secondary|"Change From Baseline in QoL Health Transition at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162640|NCT00261495|Secondary|"Change From Baseline in QoL General Health Perceptions at Week 4"|Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162641|NCT00261495|Secondary|"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"|Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162642|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 24 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 24.|week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162643|NCT00261495|Secondary|Number of Subjects With Dose Escalation at Week 4 (ITT Population)|The number of subjects with dose increase in study medication was assessed at week 4.|week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162644|NCT00261495|Secondary|"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"|"Change from baseline in subject diary mean pain score pain at its worst from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score pain at its worst."|baseline and weeks 4, 8, 12, 16, 20, and 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162712|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
162645|NCT00261495|Secondary|Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24|Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162646|NCT00261495|Secondary|Number of Subjects Indicating Optimal Sleep at Week 52|Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.|week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162647|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 52|Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162648|NCT00261495|Secondary|Number of Subjects Indicating That They Had Optimal Sleep at Week 24|Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162649|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Quantity at Week 24|Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162650|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24|Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162651|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24|Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162652|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24|Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162653|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Snoring at Week 24|Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162654|NCT00261495|Secondary|Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24|Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162655|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 24|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162656|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index II) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162713|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
162657|NCT00261495|Secondary|Change From Baseline in Sleep Quality (MOS Index I) at Week 4|Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162658|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)|Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 52|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162659|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162660|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162661|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162662|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162663|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162664|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162665|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162666|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162714|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
164319|NCT00234286|Primary|Presence of Order for Opioid Pain Medication|Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
162667|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162668|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"|"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162669|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162670|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162671|NCT00261495|Secondary|"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"|"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162672|NCT00261495|Secondary|"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"|"Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162673|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24|Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162674|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162675|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162676|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162677|NCT00261495|Secondary|Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4|Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162734|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162678|NCT00261495|Secondary|Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4|Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162679|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162680|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its worst (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162681|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162682|NCT00261495|Secondary|"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"|"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain right now (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 4|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162683|NCT00261495|Secondary|Number of Subjects With Dose Escalation|Number of subjects with dose increase in study medication.|week 4 and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Subjects|||Number
162684|NCT00261495|Secondary|"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary morning mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162685|NCT00261495|Secondary|"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"|"Change from baseline to week 24 in subject diary evening mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162686|NCT00261495|Secondary|Change From Baseline in Sleep Quality at Week 24|Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162687|NCT00261495|Primary|"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162688|NCT00261495|Secondary|"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"|"Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst."|baseline and week 24|ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)||Units on a scale||Standard Deviation|Mean
162689|NCT00261495|Primary|"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"|"Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now."|baseline and week 24|PP population (all randomized subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)||Units on a scale||Standard Deviation|Mean
162690|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities|ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--> present post-baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with ECG evaluation||Participants|||Number
162691|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities|Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with laboratory evaluation||Participants|||Number
162692|NCT00261443|Secondary|Extension Phase: Adverse Events (AEs), by Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Participants in Extension Phase Safety Sample with AEs||Participants|||Number
162693|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities|Vital sign abnormalities considered by the investigator as clinically relevant.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample||Participants|||Number
162694|NCT00261443|Secondary|Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase|Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.)|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of Participants Analyzed=Participants in Extension Phase Safety Sample; n=number of participants with evaluation||Participants|||Number
162695|NCT00261443|Secondary|Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Extension Phase Safety Sample||Participants|||Number
162696|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
162697|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point||units on a scale||Standard Error|Mean
162698|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point||units on a scale||Standard Error|Mean
162699|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
162735|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162700|NCT00261443|Secondary|Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|extension phase participants, last observation carried forward (LOCF)||units on a scale||Standard Error|Mean
162701|NCT00261443|Secondary|Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point||units on a scale||Standard Error|Mean
162702|NCT00261443|Secondary|Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample||participants|||Number
162703|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162704|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162705|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162706|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162707|NCT00261443|Secondary|Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162708|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||bpm||Full Range|Median
162709|NCT00261443|Secondary|Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement.|Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)|Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162710|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||msecs||Full Range|Median
164361|NCT00233324|Primary|Survival Without Bronchopulmonary Dysplasia (BPD)||36 weeks|||Participants|||Number
162715|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample||Participants|||Number
162716|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement||x 10^3 c/uL||Full Range|Median
162717|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162718|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162719|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162720|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||ng/mL||Full Range|Median
162721|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)|Phase 3 Safety Sample, participants with measurement||x10^9 c/L||Full Range|Median
162722|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||percent of total white blood cell count||Full Range|Median
162723|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162724|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
162725|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement||proportion of 'normal function'||Full Range|Median
162726|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value|Phase 3 Safety Sample, participants with measurement||percentage of 'normal function'||Full Range|Median
162727|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162728|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement||percentage of total blood volume||Full Range|Median
162729|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)|Phase 3 Safety Sample, participants with measurement||g/dL||Full Range|Median
162730|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162731|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample|The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count).|Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||percent of total white blood cell count||Full Range|Median
162732|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||mg/dL||Full Range|Median
162733|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
162738|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample||Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)|Phase 3 Safety Sample, participants with measurement||U/L||Full Range|Median
162739|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3|ULN=upper limit of normal; Hb=hemoglobin|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n=number of participants with measurement||participants|||Number
162740|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3||Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)|Phase 3 Safety Sample; n=number of participants with measurement at time point||kg/m^2||Inter-Quartile Range|Median
162741|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Loss During Phase 3|Relevant weight loss: >=7% decrease from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point||Participants|||Number
162742|NCT00261443|Secondary|Number of Participants Showing Relevant Weight Gain During Phase 3|Relevant weight gain: >=7% increase from baseline|Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)|Phase 3 Safety Sample; n=number of participants with measurement at time point||Participants|||Number
162743|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Weight||Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)|Observed Cases Data Set, Week 52 LOCF; n= number of participants with value at time point||kg||Standard Error|Mean
162744|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||beats per minute||Full Range|Median
162745|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
162746|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
162747|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||beats per minute ?||Full Range|Median
162748|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
162749|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF||mm Hg||Full Range|Median
162750|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)||beats per minute (bpm)||Full Range|Median
162751|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)||mm Hg||Full Range|Median
162752|NCT00261443|Secondary|Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3||Baseline, During Phase 3 (for highest/lowest values), Week 52|Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)||mm Hg||Full Range|Median
162753|NCT00261443|Secondary|Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; n= number of participants with measurement||Participants|||Number
162754|NCT00261443|Secondary|Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample; (n=number of participants in sample for each category)||Participants|||Number
162755|NCT00261443|Secondary|Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Phase 3 Safety Sample||Participants|||Number
162783|NCT00261443|Secondary|Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.||kg/m^2||Full Range|Median
168717|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42|Estimated FEV1 after bronchodilator at Month 42|Month 42|||L||Standard Error|Mean
162756|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162757|NCT00261443|Secondary|Baseline in Barnes Akathisia Global Clinical Assessment|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162758|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162759|NCT00261443|Secondary|Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162760|NCT00261443|Secondary|Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with evaluation at time point||units on a scale||Standard Error|Mean
162761|NCT00261443|Secondary|Baseline Abnormal Involuntary Movement Scale (AIMS)|The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.|Baseline|Phase 2 Safety Sample, participants with evaluation at time point||units on a scale||Standard Error|Mean
162762|NCT00261443|Secondary|Median Change From Baseline in Leukocytes at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^3 c/L||Full Range|Median
162763|NCT00261443|Secondary|Median Baseline Leukocytes||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^3 c/L||Full Range|Median
162764|NCT00261443|Secondary|Median Change From Baseline in Prolactin at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||ng/dL||Full Range|Median
162765|NCT00261443|Secondary|Median Baseline Prolactin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||ng/dL||Full Range|Median
162766|NCT00261443|Secondary|Median Change From Baseline in Platelet Count at Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^9 c/L||Full Range|Median
162767|NCT00261443|Secondary|Median Baseline Platelet Count||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||x10^9 c/L||Full Range|Median
162784|NCT00261443|Secondary|Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, participants with measurement at time point.||kg||Full Range|Median
163031|NCT00257556|Secondary|Participants With Varying Numbers of Pronuclear Stage Oocytes|Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.|Approximately study day 15|All patients treated population||participants|||Number
162768|NCT00261443|Secondary|Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||proportion of 'normal function'||Full Range|Median
162769|NCT00261443|Secondary|Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of 'normal function'||Full Range|Median
162770|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of ‘normal function.’|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||proportion of 'normal function'||Full Range|Median
162771|NCT00261443|Secondary|Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta|HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of ‘normal function.’|Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of 'normal function'||Full Range|Median
162772|NCT00261443|Secondary|Median Change From Baseline in Hematocrit||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of total blood volume||Full Range|Median
162773|NCT00261443|Secondary|Median Baseline Hematocrit||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||percentage of total blood volume||Full Range|Median
162774|NCT00261443|Secondary|Median Change From Baseline in Hemoglobin||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample, number of participants with evaluation at time point||g/dL||Full Range|Median
162775|NCT00261443|Secondary|Median Baseline Hemoglobin||Baseline|Phase 2 Safety Sample, number of participants with evaluation at time point||g/dL||Full Range|Median
162776|NCT00261443|Secondary|Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)||Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||percent of total white blood cell count||Full Range|Median
162777|NCT00261443|Secondary|Median Baseline Eosinophils (Relative) and Neutrophils (Relative)||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point||percent of total white blood cell count||Full Range|Median
162778|NCT00261443|Secondary|Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
162779|NCT00261443|Secondary|Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
162780|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||msecs||Full Range|Median
162781|NCT00261443|Secondary|Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2||Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
162782|NCT00261443|Secondary|Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample||Baseline|Phase 2 Safety Sample; n=number of participants with evaluation at time point||U/L||Full Range|Median
162785|NCT00261443|Secondary|Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||mmHg||Full Range|Median
162786|NCT00261443|Secondary|Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||beats per minute||Full Range|Median
162787|NCT00261443|Secondary|Median Baseline and Change From Baseline in ECG Measurements During Phase 2||Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n= participants with measurement at time point.||msecs||Full Range|Median
162788|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2|ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample; n=number of participants with evaluation at time point||Participants|||Number
162789|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2|Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
162790|NCT00261443|Secondary|Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2|Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate <100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.|Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
162791|NCT00261443|Secondary|Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).|During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
162792|NCT00261443|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2|Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)|Phase 2 Safety Sample||Participants|||Number
162793|NCT00261443|Secondary|Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)||Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample||Proportion of Participants|||Number
162794|NCT00261443|Secondary|Number of Participants Maintaining Remission During Phase 3|Remission is defined as Y-MRS Total Score <=12 and MADRS Total Score <=12.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Observed cases data set, Phase 3 Efficacy Sample||participants|||Number
162795|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
162796|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
168718|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42||Month 42|||L||Standard Error|Mean
162797|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
162798|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162799|NCT00261443|Secondary|Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
162800|NCT00261443|Secondary|Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162801|NCT00261443|Secondary|Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale [1 to 7], with 1 being very much improved and 7 being very much worse).|Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162802|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
162803|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162804|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
162805|NCT00261443|Secondary|Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
164525|NCT00230802|Secondary|the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State||9 months|||participants|||Number
162806|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; N=number of participants evaluated at time point; 4 participants in the Week 4 placebo group were not evaluated.||units on a scale||Standard Error|Mean
162807|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.|Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point||units on a scale||Standard Error|Mean
162808|NCT00261443|Secondary|Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3|The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the “best” rating and 4 or 8 is the “worst” rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).|Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|LOCF data set, phase 3 efficacy sample; n=number of participants with measurement at time point||units on a scale||Standard Error|Mean
162809|NCT00261443|Secondary|Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2|"The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst)."|Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)|Observed Cases (OC) data set; n=number of participants with measurement at given time point.||units on a scale||Standard Error|Mean
162810|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3|Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS > 16 and/or a MADRS > 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score > 16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point||proportion of participants|||Number
162811|NCT00261443|Secondary|Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) >16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) >16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score >16.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3|Randomized sample, n=number of participants at risk at given time point||proportion of participants|||Number
162812|NCT00261443|Secondary|Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3|Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale [1 to 7], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.|Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|LOCF data set, phase 3 efficacy sample; n=number of participants evaluated at given time point||units on a scale||Standard Error|Mean
162813|NCT00261443|Primary|Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3|Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS > 16 and/or a MADRS > 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS > 16 and/or a MADRS > 16.|Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])|Randomized Sample; n=number of participants at risk at each time point||proportion of participants|||Number
162814|NCT00260832|Secondary|Comparison of Complete Remission Rates Between Arm A and Arm B|Morphologic complete remission (CR) plus CR without platelet recovery (CRp) rate|Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available. No stated duration of response required for complete remission classification||||||
168719|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36|||L||Standard Error|Mean
162815|NCT00260832|Primary|Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.|The primary population for all efficacy analyses was the Intent-to-treat (ITT) population defined as all subjects randomly allocated to a treatment arm.||months||Full Range|Median
162816|NCT00260533|Primary|Clinical Global Impression (Change Version, Also Known as Improvement Version)|"This is a commonly used, clinician-rated measure of clinical improvement.~The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.~For purposes of analysis, subjects rated as (1) Very Much Improved or (2) Much Improved were considered responders."|10 weeks (end of study)|||participants|||Number
162817|NCT00260429|Secondary|Change From Baseline Range of Motion After the First Injection||30 days after first treatment to the primary joint||||||
162818|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the First Injection||30 days after first treatment to the primary joint||||||
162819|NCT00260429|Secondary|Clinical Success After the First Injection||30 days after first treatment to the primary joint||||||
162820|NCT00260429|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection||First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint||||||
162821|NCT00260429|Secondary|Percent Change From Baseline Range of Motion After the Last Injection||30 days after last treatment to the primary joint||||||
162822|NCT00260429|Secondary|Percent Reduction From Baseline Contracture After the Last Injection||30 days after last treatment to the primary joint||||||
162823|NCT00260429|Primary|Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.|"The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less.~The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where successfully treated was defined as reduction in contracture to 5° or less."|30 days after the last injection|||% Joints|||Number
162824|NCT00260208|Secondary|Mean Fibrosis Score|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. The mean score was equivalent to mean of IK at 1 and 2 years (evolution over time).|At 1and 2 years and its evolution over time|This outcome was not analyzed because of premature termination of study.||units on a scale||Standard Deviation|Mean
162825|NCT00260208|Secondary|Percentage of Participants With an Increase of at Least 1 Stage in Fibrosis|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. An increase of at least 1 stage demonstrated a worsening of the disease, i.e. the transition from one score to the next higher one.|Between 1 and 2 years|The outcome measure was not analyzed because of premature termination of study.||Percentage of participants|||Number
162826|NCT00260208|Secondary|Log-transformed Hepatitis C Virus Ribonucleic Acid (HCV RNA) Values up to 1 Year Post Transplant|HCV RNA was measured (IU/µL)centrally pre-transplant (Day 1) and at 48 hours (Day 3), Day 8 and 29, Month 6 and 12 post-transplant and concomitantly to any additional biopsies performed.|Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n in each of the categories is the number of participants with data at the given time point."||IU/µL||Standard Deviation|Mean
162827|NCT00260208|Secondary|Mean Value of Liver Function Tests at 1 Year Post-transplantation|"The mean value (in Units per liter, IU/L) of following tests were calculated at 1 year post-transplant:~Serum glutamic pyruvic transaminase (SGPT)~Serum Glutamic Oxaloacetic Transaminase (SGOT)~Bilirubin~Alkaline Phosphate~γ-Glutamyltransferase (GGT)"|1 year post-transplant|"Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. n is number participants with assessable data in each category."||IU/L||Standard Deviation|Mean
162828|NCT00260208|Secondary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant (Intent to Treat Population)|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|The Intent-To-Treat (ITT) population consisted of all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
162829|NCT00260208|Secondary|Number of Participants With Death or Re-transplantation Due to Recurrence of Hepatitis C Cirrhosis|Cirrhosis was resulted due to the recurrence of the hepatitis C virus infection in the transplanted liver.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
162969|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162830|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Biopsy Proven Acute Rejection (BPAR)|BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
162831|NCT00260208|Secondary|Number of Participants With Treated Acute Rejection, Biopsy Proven Acute Rejection (BPAR), and Sub-clinical Rejection|Treated acute rejection is defined as an acute rejection, clinically suspected, whether biopsy-proven or not, which has been treated and confirmed by the investigator according to the response to therapy. BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. A sub-clinical rejection was defined as a rejection identified by center driven biopsy, i.e. a biopsy performed routinely at some pre-defined time points after transplantation as per center practice in the absence of any clinical signs of rejection.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
162832|NCT00260208|Secondary|Number of Participants With Death, Graft Loss, Death or Graft Loss, Graft Loss With Re-transplantation|Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
162833|NCT00260208|Secondary|Number of Participants With Fibrosing Cholestatic Hepatitis|Fibrosing cholestatic hepatitis (FCH) is characterized by progressive jaundice with a rapid decline in liver function leading to liver failure, most often associated with markedly elevated viral levels detected in the bloodstream (e.g. more than 20 times pre-liver transplantation levels) and in the liver tissue as well. The presence of FCH was reported based on the diagnosis given by the investigator.|1 year post-transplantation|Intent-to-treat population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
162834|NCT00260208|Secondary|Number of Participants With Combined Endpoint of Death or Graft Loss or Fibrosis Score (FS) ≥ 2|The number of participants with combined end point of death or graft loss or presented with a Ishak-Knodell fibrosis score (FS) ≥2 was calculated. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had liver retransplant or died. Assessment of hepatic fibrosis was performed with liver biopsies read centrally. Ishak-Knodell FS was used to stage liver disease; 0=none; 1=portal fibrosis (some); 2=portal fibrosis (most); 3=bridging fibrosis (few); 4=bridging fibrosis (many); 5=Incomplete cirrhosis; 6=cirrhosis. Higher score indicates greater fibrosis.|1 year post-transplant|Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.||Participants|||Number
162835|NCT00260208|Primary|Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant|Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. Logistic regression on the presence of IK>=2 was applied based on central biopsy readings only.|1 year post-transplant|The modified intent-to-treat population (mITT) included patients treated with study drug at least up to 30 days before Month 12 visit and a liver biopsy had to be performed at this visit. Also included were patients with an earlier biopsy that showed an Ishak-Knodell fibrosis score ≥2 and treated at least up to 30 days before that biopsy was taken.||Participants|||Number
162836|NCT00260195|Primary|Teacher Report of Behavior Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicates more problems, with total problem area scores ranging from 0 to 40.|Problems over the month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
162837|NCT00260195|Primary|Parent Report of Behavioral Problems|Strengths and Difficulties Questionnaire—Parent Report, and Teacher Report (SDQ, Goodman, 1997; Goodman, Meltzer, & Bailey, 1998) This questionnaire contains 25 items, 20 assessing problem areas (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems), 5 assessing prosocial behavior, and items that tap functional impairment related to these problems (Goodman, 1999). Higher scores indicate more problems, with total scores for problem areas ranging from 0 to 40.|Problems over the prior month were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
162838|NCT00260195|Primary|Depressive Symptoms|Children’s Depression Inventory (CDI; Kovacs, 1981) This 27-item measure assesses children’s cognitive, affective, and behavioral depressive symptoms. The scale has high internal consistency, moderate test-retest reliability, and correlates in the expected direction with measures of related constructs (e.g., self-esteem, negative attributions, and hopelessness; Kendall, Cantwell, & Kazdin, 1989). Normative data are available (Finch, Saylor, & Edwards, 1985). We used a 26-item version of the scale that omits an item about suicidal ideation. Higher scores indicate more symptoms, and total scores can range from 0 to 52.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
162893|NCT00259012|Primary|Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration|Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.|7 days|All patients for whom at least 2 PK samples were obtained after 5 consecutive doses. Low dose population was 19 for both 2 and 4 hours. High dose population was 17 and 18 for 2 and 4 hours respectively.||ng/mL||Standard Deviation|Mean
162839|NCT00260195|Primary|Post-traumatic Stress Disorder Symptoms|We used the Child PTSD Symptom Scale (CPSS; Foa,Treadwell, Johnson, & Feeny, 2001), to assess PTSD symptoms for both screening into the program and for use in examining child outcomes over time. This scale has been used in school aged children as young as 8 and has shown good convergent and discriminant validity and high reliability (Foa et al., 2001). In our earlier work, scale internal consistency was high (Cronbach’s alpha = 0.89; Jaycox et al., 2002). In this study, we use it as a continuous scale as designed, and also use cut-points to determine eligibility for the study as in prior work (Kataoka et al., 2003; Stein et al., 2003), requiring a total score of 11 or greater, indicating moderate levels of current PTSD symptoms. A high score indicates more symptoms, and total scores can range from 0 to 51.|Symptoms over the past two weeks were assessed at baseline, after intervention for the SSET group (10 weeks), and after all receive intervention (20 weeks).|||units on a scale||Standard Deviation|Mean
162840|NCT00260065|Secondary|Best Response and Overall Improvement|Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)|1 year|Intent-to-treat (ITT)||Participants|||Number
162841|NCT00260065|Primary|Number of Participants Who Achieved Overall Response|Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)|1 year|Intent-to-treat (ITT)||participants|||Number
162842|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of participants with fractures at the completion of therapy.|24 months|Number of participants with fractures at study completion.||participants|||Number
162843|NCT00259857|Secondary|Participants With Atraumatic Fractures|Number of Participants with Atraumatic fractures before therapy.|0 months|Number of participants with fractures before therapy.||participants|||Number
162844|NCT00259857|Secondary|Number of Participants With Improvement in BMD of Hip|Analysis was done per protocol and intention to treat.|24 months of therapy|Analysis was done per protocol and intention to treat.||participants|||Number
162845|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.|24 months therapy|Analysis was done per protocol and intention to treat.||participants|||Number
162846|NCT00259857|Secondary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy||12 months of therapy|Analysis was done per protocol and intention to treat.||participants|||Number
162847|NCT00259857|Primary|Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy|Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.|12 months therapy|Analysis was done per protocol and intention to treat.||participants|||Number
162848|NCT00259740|Secondary|Complete Response Based on M-Protein Assessments Only|Complete response based on M-protein assessments, as defined for the primary outcome measure.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab||Participants|||Number
162849|NCT00259740|Secondary|Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only|Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab||Participants|||Number
162850|NCT00259740|Primary|Complete Response or Partial Response Based on M-Protein Assessments Only|Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.|Up to 18 months|All participants who completed the first cycle of treatment with denosumab||Participants|||Number
162851|NCT00259649|Primary|Change in Mean Headache Index Score Among Patients|Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy|baseline to approximately three months|||headache index score||Standard Error|Mean
162852|NCT00259610|Secondary|Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.|Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24.|Year 2, Week 102|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.||Scores on a scale||Standard Deviation|Mean
162853|NCT00259610|Primary|Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)|"Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The ESR is the rate at which red blood cells sediment in a period of one hour.~The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity."|Change of the Mean of DAS28-ESR between weeks 48 - 102.|The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.||Scores on a scale||Standard Deviation|Mean
163025|NCT00257556|Secondary|Mean Estradiol Level|Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.|Day 7 or 9 or 11 or 13|All patient treated population||picomoles / liter||Standard Deviation|Mean
162854|NCT00259298|Primary|Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).|baseline, 18 months|All participants with a baseline observation and at least 1 post-baseline observation.||percentage of change of plasma clearance||Inter-Quartile Range|Median
162855|NCT00259298|Secondary|Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton|Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.|baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||participants|||Number
162856|NCT00259298|Secondary|Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton|Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting <1% of skeleton; 2=focal areas affecting >=5% of skeleton; 3=focal areas affecting >=20% of skeleton; 4=focal areas affecting >=50% of skeleton.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||units on a scale||Standard Deviation|Mean
162857|NCT00259298|Secondary|Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||percentage of change of skeletal uptake||Inter-Quartile Range|Median
162858|NCT00259298|Secondary|Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities|Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.|Baseline, 3 months, 18 months, 24 months|All participants with a baseline observation and at least 1 post-baseline observation.||percentage of change of plasma clearance||Inter-Quartile Range|Median
162859|NCT00259285|Secondary|Relapse-free Survival|Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.|Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter|||months||Standard Deviation|Mean
162860|NCT00259285|Secondary|Pathologic Remissions After Surgery|The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.|surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)|7 out of the 10 patients had surgery.||participants|||Number
162861|NCT00259285|Primary|Treatment Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 21 day cycle (3 cycles) and 3-4 weeks after last cycle|||participants|||Number
162862|NCT00259272|Primary|Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix|This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.|Baseline|Matrix based on data from all 141 participants.||value|||Number
162863|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink|To assess emotional reactivity with the physiological measure of startle reflex response - by measuring the amplitude of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||microvolts||Standard Deviation|Mean
162864|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink|To assess emotional reactivity with the physiological measure of startle reflex response by measuring the latency of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||seconds||Standard Deviation|Mean
162865|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Skin Conductance|To assess emotional reactivity with the physiological measure of skin conductance, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||microvolts||Standard Deviation|Mean
162866|NCT00259272|Secondary|Emotional Reactivity With the Physiological Measure of Heart Rate|to assess emotional reactivity with the physiological measure of heart rate, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients|12 weeks|Measures were to be collected at only one site. Not enough data to analyze.||beats per minute||Standard Deviation|Mean
168720|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36||Month 36|||L||Standard Error|Mean
162867|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162868|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162869|NCT00259272|Secondary|Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162870|NCT00259272|Secondary|MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment|A visual analogic scale consisting of 20 items. Items scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18, which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162871|NCT00259272|Secondary|Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)||24 weeks|Subgroup of patients who gained more than 7% of body weight.||participants|||Number
162872|NCT00259272|Secondary|Weight Gain Compared to Baseline|Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline|over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.||participants|||Number
162873|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Weight||Baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.||kilograms||Standard Deviation|Mean
162874|NCT00259272|Secondary|Increases and Decreases in Lipid Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.||participants|||Number
162875|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Lipids|Baseline, change from baseline, and percent change for the following lipids are presented: Total Cholesterol (TC), High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), and Triglycerides (TG).|Baseline and 24 Weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.||milligrams per deciliter||Standard Deviation|Mean
162876|NCT00259272|Secondary|Increases and Decreases in Fasting Glucose Levels||over 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug.||participants|||Number
162877|NCT00259272|Secondary|Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)||baseline and 24 weeks|Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.||milligrams per deciliter||Standard Deviation|Mean
162878|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162879|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score|The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162880|NCT00259272|Secondary|Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).|Baseline, 6 Weeks, 24 Weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162881|NCT00259272|Primary|Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score|A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.|Baseline, 6 Weeks, 24 weeks|Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.||units on a scale||Standard Deviation|Mean
162917|NCT00258830|Primary|Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination||Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects intent-to-treat safety population with available reaction data.||Participants|||Number
162882|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index.|For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|||Percentage change from baseline||Standard Error|Mean
162883|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score.|For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|nine patients with PgR=0 at baseline were excluded from analysis of PgR because the question of medical interest was the effect of treatment on PgR positive patients.||Percentage change from baseline||Standard Error|Mean
162884|NCT00259090|Primary|Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.|For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100|Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)|||Percentage change from baseline||Standard Error|Mean
162885|NCT00259012|Primary|Normalized Area of Esophageal Hydrogen Ion Activity Over Time|Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||H*mmol/L||Standard Deviation|Mean
162886|NCT00259012|Primary|Normalized Area of Gastric Hydrogen Ion Activity Over Time|Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||H*mmol/L||Standard Deviation|Mean
162887|NCT00259012|Primary|Percentage of Time That Intraesophageal pH Was <4|Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||percentage of time||Standard Deviation|Mean
162888|NCT00259012|Primary|Median Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
162889|NCT00259012|Primary|Mean Intraesophageal pH|Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
162890|NCT00259012|Primary|Percentage of Time Intragastric pH Was >4|Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||percentage of time||Standard Deviation|Mean
162891|NCT00259012|Primary|Median Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
162892|NCT00259012|Primary|Intragastric pH|Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH <4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).|7 days|Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed.||units on scale||Standard Deviation|Mean
163026|NCT00257556|Secondary|Mean Endometrial Thickness|Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.|Day 7 or 9 or 11 or 13|All patients treated population||millimeters||Standard Deviation|Mean
162894|NCT00259012|Primary|Apparent Oral Clearance (CL/F)|Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||L/hr/kg||Standard Deviation|Mean
162895|NCT00259012|Primary|Area Under the Concentration-time Curve (AUC)|Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||ng*hr/mL||Standard Deviation|Mean
162896|NCT00259012|Primary|Disposition Half-life|Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||hr||Standard Deviation|Mean
162897|NCT00259012|Primary|Time to Peak Concentration (Tmax) Profile|Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||hr||Full Range|Median
162898|NCT00259012|Primary|Peak Concentration (Cmax)|Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole|1 day|All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated.||ng/mL||Standard Deviation|Mean
162899|NCT00258908|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination|The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose|Within 8 days of vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population.||Percentage of Participants|||Number
162900|NCT00258908|Primary|Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination|GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 post-vaccination|Geometric Mean Titers were evaluated in the per-protocol immunogenicity population.||Titers||95% Confidence Interval|Geometric Mean
162901|NCT00258908|Primary|Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination|Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.|Day 0 and Day 28 Post-vaccination|Seroprotection to each vaccine antigen was evaluated in the per-protocol immunogenicity population||Percentage of participants|||Number
162902|NCT00258895|Primary|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination||Day 0 and between Days 28-48 post-dose 5|GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.||All units||95% Confidence Interval|Geometric Mean
162903|NCT00258895|Primary|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.||Day 0 and between Days 28-48 Post-dose 5|Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.||Percentage of Participants|||Number
162904|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination|Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.|Day 28 to 48 Post-Dose 5|The anti-pertussis booster response was assessed in the per-protocol immunogenicity population.||Percentage of Participants|||Number
162905|NCT00258895|Primary|Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination|Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.|Day 28 to 48 Post-dose 5|The anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.||Percentage of Participants|||Number
162906|NCT00258895|Primary|Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination||0 to 7 days Post-Dose 5|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.||Percentage of Participants|||Number
162907|NCT00258882|Primary|Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls.|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.||Infants|||Number
162908|NCT00258882|Primary|Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls|Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.|Pregnancy to Delivery, up to 9 months|All persons in the database searches as being vaccinated with Adacel vaccine during pregnancy or within 28 days prior to becoming pregnant and age-matched pregnant controls who did not receive Adacel vaccine.||Participants|||Number
162909|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.|Days 0 to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events per 1000 Person-months|||Number
162910|NCT00258882|Primary|All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.|Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events Per 1000 Person-months|||Number
162911|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.~Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study."|Days 0 up to 180 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events Per 1000 Person-months|||Number
162912|NCT00258882|Primary|Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database|"The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.~Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination."|Days 0 to 60 and Day 61 to 120 following vaccination|Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.||Events Per 1000 Person-months|||Number
162913|NCT00258856|Primary|Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.|"Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.~Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination."|7 or 14 days post-vaccination|Serum bactericidal assay performed using baby rabbit complement (SBA-BR) titers for each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.||Percentage of participants|||Number
162914|NCT00258830|Other Pre-specified|Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination|Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the per-protocol population.||Percentage of participants|||Number
162915|NCT00258830|Other Pre-specified|Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.|Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.|21 Days post-vaccination|Seroprotection was assessed in the per-protocol population||Percentage of participants|||Number
162916|NCT00258830|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination|GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005–2006 Formulation)|21 days post-vaccination|GMT results were assessed on the per-protocol population.||Titer||95% Confidence Interval|Geometric Mean
162918|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2|"Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting~Note: Influenza vaccine-primed group received only dose 1"|0 to 3 days post-vaccination 2|Safety analysis post vaccination 2 was on all enrolled and vaccinated subjects, Intend-to-treat population.||Participants|||Number
162919|NCT00258817|Other Pre-specified|Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1|Solicited local reactions: injection site erythema, injection site swelling, injection site tenderness; Solicited systemic reactions: fever (temperature), irritability, abnormal crying, drowsiness, lost appetite, and vomiting.|0 to 3 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated subjects, Intend-to-treat population.||Participants|||Number
162920|NCT00258817|Primary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination|"GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation.~Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)"|Day 14 post-vaccination|Geometric Mean Titers were assessed on the per-protocol population.||Titer||95% Confidence Interval|Geometric Mean
162921|NCT00258674|Secondary|"Change Score for Semiannual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for a semi-annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
162922|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
162923|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
162924|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medicare Claims Data)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
162925|NCT00258674|Secondary|"Change Score for Annual Renal Function Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual renal function assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
162926|NCT00258674|Secondary|"Change Score for Annual Eye Exam (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual eye exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were not available at either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
162927|NCT00258674|Secondary|"Change Score for Annual Foot Exam (as Determined by Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual foot exam in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom baseline or follow-up records were not available were excluded.||units on a scale||Standard Deviation|Mean
162928|NCT00258674|Secondary|"Change Score for Annual Blood Pressure Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual blood pressure assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.||units on a scale||Standard Deviation|Mean
163027|NCT00257556|Secondary|Pregnancy Outcomes|Long term follow-up to determine the outcome of the pregnancy.|Approximately 10 months|All patients treated population||participants|||Number
168721|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30|||L||Standard Error|Mean
162929|NCT00258674|Secondary|"Change Score for Annual Lipid Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual lipid assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom either baseline or follow-up records were missing were excluded.||units on a scale||Standard Deviation|Mean
162930|NCT00258674|Secondary|"Change Score for Annual HbA1c Assessment (as Determined From Medical Record Review)"|Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient who was non-compliant with the guideline recommendation for an annual HbA1c assessment in the baseline period was compliant in the follow-up period. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients for whom records were missing for either baseline or follow-up were excluded.||units on a scale||Standard Deviation|Mean
162931|NCT00258674|Secondary|"Change Score for Systolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.||mmHg||Standard Deviation|Mean
162932|NCT00258674|Secondary|"Change Score for LDL Level"|Change score was calculated by subtracting the follow-up LDL value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.||mg/dL||Standard Deviation|Mean
162933|NCT00258674|Secondary|"Change Score for Diastolic Blood Pressure"|Change score was calculated by subtracting the follow-up value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up blood pressure measurement were excluded.||mmHg||Standard Deviation|Mean
162934|NCT00258674|Secondary|"Change Score for HbA1c Level"|Change score was calculated by subtracting the follow-up HbA1c value from the baseline value for each patient. Patients missing either a baseline or follow-up value were excluded. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (1/1/2000-12/31/2000) to follow-up (1/1/2001-12/31/2001)|Patients missing either a baseline or follow-up HbA1c value were excluded.||change in percentage of glycosolated-Hb||Standard Deviation|Mean
162935|NCT00258674|Primary|"Change Score for Blood Pressure (b.p.) <130/80 mmHg"|Each patient was assigned a change score of -1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of blood pressure <130/80 mmHg at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm.|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/200112/31/2001)|Patients missing either a baseline or follow-up blood pressure value were excluded.||units on a scale||Standard Deviation|Mean
162936|NCT00258674|Primary|"Change Score for LDL <100 mg/dL"|"Each patient was assigned a change score of –1, 0, or 1. A positive value indicated that a patient non-adherent to the guideline recommendation of LDL <100 mg/dL at baseline had achieved adherence at follow-up. Patient-level change scores were then summed and averaged over each study arm."|change from baseline (01/01/2000-12/31/2000) to follow-up (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up LDL values were excluded.||units on a scale||Standard Deviation|Mean
162937|NCT00258674|Primary|"Change Score for HbA1c <9 Percent"|"Each patient was assigned a change score of –1, 0, or 1. A positive value indicated a patient non-adherent to the guideline recommendation for HbA1c <9 percent at baseline had achieved such a level at follow up. Patient-level change scores were then summed and averaged over each study arm."|This measure compared baseline values (01/01/2000-12/31/2000) to follow-up values (01/01/2001-12/31/2001)|Patients missing either baseline or follow-up values for HbA1c were excluded.||units on a scale||Standard Deviation|Mean
162938|NCT00258440|Secondary|Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.||On study, averaging 3 to 6 months.|||events|||Number
162939|NCT00258440|Secondary|Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28||weeks 4,8,16,24 and 28||||||
162940|NCT00258440|Secondary|Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.||every other week||||||
162941|NCT00258440|Primary|Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks||12 weeks|Due to low accrual numbers and the discontinuation of the study early a full analysis was not completed.||participants|||Number
162942|NCT00258362|Secondary|Percent of Patients Estimated to be Alive|This estimate of overall survival was determined by using the statistical method (Kaplan-Meier) of analysis.|1 Year, 2 Years, 3 Years|All 41 patients were included in this analysis.||Percentage of Patients|||Number
162943|NCT00258362|Primary|Percent of Patients Estimated to be Progression-Free and Alive|This estimate was determined by using a statistical method of analysis (Kaplan-Meier).|1 Year, 2 Years, 3 Years|Two patients with recurrent disease at study entry were excluded from this analysis.||Percentage of Patients|||Number
162944|NCT00258349|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients who were alive were censored as the last date of known alive.|Survival was assessed every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|10 eligible HER2-positive (by central review) patients||months||95% Confidence Interval|Median
162968|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen|GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
168722|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30||Month 30|||L||Standard Error|Mean
162945|NCT00258349|Secondary|Time to Progression|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Disease progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). Time to progression is defined as time from registration to disease progression.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients||months||95% Confidence Interval|Median
162946|NCT00258349|Primary|Response Rate|Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy|10 eligible HER2-positive (by central review) patients||percentage of participants||95% Confidence Interval|Number
162947|NCT00258310|Secondary|Incidence of Second Primary Tumor Occurrence||Every 12 months||||||
162948|NCT00258310|Secondary|Survival Rate||from time of study entry until death||||||
162949|NCT00258310|Secondary|Local-regional Control Rate Occurrence||within 365 days||||||
162950|NCT00258310|Secondary|Time to Recurrence||assessed from time of study entry until documented||||||
162951|NCT00258310|Primary|Feasibility of Treatment as Assessed.|Compliance was taking at least 80% of the prescribed dose for one year.|within 365 days|||percentage of participants||95% Confidence Interval|Number
162952|NCT00258206|Secondary|Overall Survival||5 years||||||
162953|NCT00258206|Secondary|Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited||2, 3, 6, 9, and 12 months||||||
162954|NCT00258206|Secondary|Complete Response (CR) Rate and Partial Response (PR) Rate||1 year||||||
162955|NCT00258206|Secondary|Safety and Toxicity||2, 3, 6, 9, and 12 months||||||
162956|NCT00258206|Primary|Safety of Maintenance Rituximab Following High Dose Cyclophosphamide||2, 3, 6, 9, and 12 months||||||
162957|NCT00258206|Primary|Event-free Survival|Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)|1 year|||percentage of participants|||Number
162958|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162959|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162960|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162961|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162962|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162963|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162964|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162965|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1|GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162966|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
162967|NCT00258154|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1|GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||GMT||95% Confidence Interval|Geometric Mean
163634|NCT00247273|Secondary|Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population|ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT||ug / L||95% Confidence Interval|Least Squares Mean
162970|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
162971|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
162972|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
162973|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
162974|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis||EU/mL||95% Confidence Interval|Least Squares Mean
162975|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1|GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis||EU/mL||95% Confidence Interval|Geometric Mean
162976|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation numbers||Dilution Unit||95% Confidence Interval|Geometric Mean
162977|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation numbers)||IU/mL||95% Confidence Interval|Geometric Mean
162978|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset B (subjects with odd allocation number)||IU/mL||95% Confidence Interval|Geometric Mean
162979|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1|GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset B (subjects with odd allocation number)||IU/mL||95% Confidence Interval|Geometric Mean
162980|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
162981|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
162982|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen|42 days after in a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
162983|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Pre-dose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
163028|NCT00257556|Secondary|Mean Number of Days Stimulated With Gonadotrophins|Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.|study days 1 - 13|All patients treated population||days||Standard Deviation|Mean
162984|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa , 42 days after a 3-dose regimen|42 days after a 3-dose regimen|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
162985|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen|42 days after a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||ng/mL||95% Confidence Interval|Geometric Mean
162986|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1|GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen|Day 1 of 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||ng/mL||95% Confidence Interval|Geometric Mean
162987|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen|GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen|42 days after 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||mIU/mL||95% Confidence Interval|Geometric Mean
162988|NCT00258154|Secondary|Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1|GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen|Predose (Day 1 of a 3-dose regimen)|Per Protocol Analysis on Subset A (subjects with even allocation numbers)||Dilution Unit||95% Confidence Interval|Geometric Mean
162989|NCT00258154|Primary|Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1|Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen|Day 1 of a 3-dose regimen|All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.||mIU/mL||95% Confidence Interval|Geometric Mean
162990|NCT00258011|Secondary|Urinary Glycosaminoglycan (GAG) Excretion|Percentage change in the concentration of GAG relative to creatinine in urine (ug GAG/mg creatinine) from baseline to last study visit. Greater decrease indicates greater response.|Up to 73 Weeks|"The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat. >~* 1 patient final visit = Week 73; 1 patient final visit = Week 32; 1 patient final visit = Week 10"||percent change in concentration of GAG||Standard Deviation|Mean
162991|NCT00258011|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|Up to 73 Weeks|The study enrolled eligible MPS I patients prior to marketing authorization in Japan. The analysis was intention to treat.||participants|||Number
162992|NCT00257933|Secondary|Rate of Relapse Between Treatment Groups||2 weeks after hospitalization||||||
162993|NCT00257933|Secondary|Differences in Clinical Asthma Symptom Scores During Hospitalization Between Treatment Groups||Every 4 hours during hospitalization||||||
162994|NCT00257933|Secondary|The Rate and Degree of Change in Forced Expiratory Volume (FEV1) and Peak Expiratory Flow (PEF) Between Treatment Groups||Every 4 hours during hospitalization||||||
162995|NCT00257933|Secondary|Time Spent in Each Severity Level of the Asthma Care Pathway||Time spent in each severity level of pathway||||||
162996|NCT00257933|Secondary|Time Measured From the Writing of the Admission Order Until the Writing of the Discharge Order||Mean time from writing admit order until discharge order||||||
162997|NCT00257933|Primary|Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered||Median time from loading dose to home dose of albuterol|||Hours||Inter-Quartile Range|Median
162998|NCT00257920|Primary|Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|Per-Protocol Population - all subjects who completed both Period 1 and 2 and did not have major protocol violations.||Fractions||Standard Error|Least Squares Mean
162999|NCT00257920|Secondary|Calcium Absorption Fractions Analyzed by Mixed Model|Calcium Absorption Fraction obtained at the end of Period 1 & Period 2|42 Days|ITT Population -all randomized subjects who received at least one dose of study drug and were analyzed by the randomized treatment sequence assigned to each subject.||Fractions||Standard Error|Least Squares Mean
163000|NCT00257894|Primary|Minnesota Nicotine Withdrawal Questionnaire|"Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal).~These data are only available on the subset of participants who participated through Day 10."|Day 10|||units on a scale||Standard Deviation|Mean
163001|NCT00257894|Secondary|Cigarette Choice Task|"At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed).~These data are only available on the subset of participants who participated through Day 10."|Tenth day of medication titration|||choices||Standard Deviation|Mean
163002|NCT00257894|Secondary|Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.|"Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse).~These data are only available on the subset of participants who participated through Day 10.."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.|||units on a scale||Standard Deviation|Mean
163003|NCT00257894|Primary|Total Score on Questionnaire of Smoking Urges|"Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge).~These data are only available on the subset of participants who participated through Day 10."|Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.|||units on a scale||Standard Deviation|Mean
163004|NCT00257686|Secondary|Percent Change From Baseline in TC|Percent change from baseline in total cholesterol (TC)|Baseline to 12 weeks|||Percent change||Standard Deviation|Mean
163005|NCT00257686|Primary|Percent Change From Baseline in LDL-C|Percent change from baseline in low density cholesterol (LDL-C)|Baseline to 12 weeks|||Percent change||Standard Deviation|Mean
163006|NCT00257660|Secondary|Number of Participants Considered by the Investigator to be Overall Treatment Successes|The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.|Week 12|Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo.||participants|||Number
163007|NCT00257660|Secondary|SF-36 Physical Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
163008|NCT00257660|Secondary|SF-36 Mental Health Summary Score|SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).|Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
163009|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.||points on a scale||Standard Deviation|Mean
163010|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 12|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline, Week 4 and Week 8 values.||points on a scale||Standard Deviation|Mean
163011|NCT00257660|Secondary|Investigator's VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values.||points on a scale||Standard Deviation|Mean
163012|NCT00257660|Secondary|Subject VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).|Baseline and Week 8|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline and Week 4 values.||points on a scale||Standard Deviation|Mean
163013|NCT00257660|Secondary|Investigator VAS for CD Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
163014|NCT00257660|Secondary|Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment|The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).|Baseline and Week 4|Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4. There was no imputation of missing VAS scores, so these 13 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
163029|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Frozen|Number of participants with different categories of number of embryos frozen.|Approximately study day 17|All patients treated population||participants|||Number
163030|NCT00257556|Secondary|Participants With Varying Numbers of Embryos Transferred|Number of participants with various categories of numbers of embryos transferred.|Approximately study day 17|All patients treated population||participants|||Number
168723|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24|||L||Standard Error|Mean
163015|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 12|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
163016|NCT00257660|Secondary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 8|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
163017|NCT00257660|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.|Baseline and Week 4|The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.||points on a scale||Standard Deviation|Mean
163018|NCT00257608|Secondary|Overall Survival|Overall survival was defined as the length of time from randomization to death.|Approximately 3.5 years|Intent-to-treat population included all participants who were randomized during the post-chemotherapy phase.||months||95% Confidence Interval|Median
163019|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation|Participants in post-chemotherapy phase were discontinued from the study for the reasons other than disease progression. Data presented Up to data cutoff 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.. N= Number of participants analyzed.||participants|||Number
163020|NCT00257608|Secondary|Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase|Participants who experienced disease progression were discontinued from the study. Data presented up to data cutoff (18 July 2008).|Approximately 3 years|Enrolled participants: All participants who were enrolled in the study. N= Number of participants analyzed.||participants|||Number
163021|NCT00257608|Secondary|Number of Participants With Any Adverse Events During Post-Chemotherapy Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. Data presented up to data cutoff 19 June 2009.|Approximately 3.5 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed. At the time of the 28 January 2009 data cutoff, an additional 25 patients had been randomized.||participants|||Number
163022|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase|Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. Pulmonary hemorrhage, GI perforation, ATE events, proteinuria, CHF, and hypertension were prospectively identified TEAEs of grade >=3. Data presented until cut-off date 28 January 2009.|Approximately 3 years|Safety-evaluable randomized Participants: All randomized Participants who received at least one complete or partial dose of Bevacizumab + Erlotinib or Bevacizumab + Placebo. N= Number of participants analyzed.||participants|||Number
163023|NCT00257608|Secondary|Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase|Treatment-emergent adverse events were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.. Number of participants who had Grade >=3TEAEs of pulmonary hemorrhage, gastrointestinal (GI) perforation, arterial thromboembolic (ATE) events, proteinuria, congestive heart failure (CHF), and hypertension were presented. Data presented up to data cutoff 18 July 2008.|Approximately 3 years|Safety-evaluable enrolled participants: All participants who enrolled and received at least one dose of chemotherapy or Bevacizumab. N= Number of participants analyzed.||participants|||Number
163024|NCT00257608|Primary|Progression-free Survival (PFS)|PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.|Approximately 3 years|Intent to treat (ITT) population included all participants who were randomized during the post-chemotherapy phase.||months||95% Confidence Interval|Median
163032|NCT00257556|Secondary|Participants With Varying Numbers of Oocytes Retrieved|Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter.|Approximately study day 15|All treated patients population.||participants|||Number
163033|NCT00257556|Secondary|Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters|The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.|Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)|All treated patients population||participants|||Number
163034|NCT00257556|Primary|Percentage of Participants With an Ongoing Pregnancy|Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.|Approx week 13; 9 weeks or more after the first positive pregnancy test|"All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as YES for ongoing pregnancy."||percentage of participants|||Number
163035|NCT00257556|Primary|Number of Participants With an Ongoing Pregnancy|Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.|Approx week 13; 9 weeks or more after the 1st positive pregnancy test|All patients treated population||participants|||Number
163036|NCT00257322|Primary|Participants Exhibiting Immune Response|Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.|24 Months|||Participants|||Number
163037|NCT00257322|Secondary|Response Rates and Overall Survival.|Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted.|24 Months|||Participant|||Number
163038|NCT00257309|Primary|Death/Reinfarction/Disabling Stroke at 30 Days|Incidence of Death or Reinfarction or Disabling Stroke at 30 days|30 days|||Participants|||Count of Participants
163039|NCT00257309|Primary|Incidence of Death or Reinfarction or Disabling Stroke|Incidence of all-cause death or myocardial reinfarction or disabling stroke|30 days|||participants|||Number
163040|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||participants|||Number
163041|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Attendance|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||participants|||Number
163042|NCT00257192|Secondary|Number of Subjects Per Response on the School Placement Questionnaire: School Situation|School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.|Baseline, Week 2, Week 6, ET|ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||participants|||Number
163043|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score|AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163515|NCT00249249|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|percent change from baseline in high density lipoprotein-cholesterol (HDL-C)|Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||percent change||Standard Deviation|Mean
163044|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item|BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163045|NCT00257192|Secondary|Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)|SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163046|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).||scores on a scale||Standard Deviation|Mean
163047|NCT00257192|Secondary|Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales|A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).|Baseline, Week 6, ET|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).||scores on a scale||Standard Deviation|Mean
163048|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 2, Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163049|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163050|NCT00257192|Secondary|Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score|CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163051|NCT00257192|Secondary|Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score|CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.|Baseline, Week 1 through Week 6|ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163052|NCT00257192|Secondary|Change From Baseline in Child Health Questionnaire (CHQ)|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child’s physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Week 6, ET|ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163053|NCT00257192|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the “normal” range; lower score indicates need for increased supervision.|Baseline, Week 2, Week 4, Week 6, Early termination (ET)|ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward [LOCF] imputation used for Week 6 LOCF timepoint.||scores on a scale||Standard Deviation|Mean
163054|NCT00257192|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Week 6|CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
163055|NCT00257192|Secondary|Change From Baseline in PANSS: Positive and Negative Subscales at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
163056|NCT00257192|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6|PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
163057|NCT00257192|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6|CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.|Baseline, Week 6|ITT; N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
163058|NCT00257192|Primary|Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline, Week 6|Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.||scores on a scale||Standard Error|Least Squares Mean
163059|NCT00257166|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Week 1, 2, 3, 4|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
163060|NCT00257166|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).|Baseline, Week 1, 2, 3, 4|ITT population. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
163061|NCT00257166|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 1, 2, 3|ITT population. ‘N’ (number of participants analyzed) signifies those participants who were available for this measure. ‘n’ signifies those participants who were available for this measure at given time points for each group respectively.||units on a scale||Standard Deviation|Mean
163062|NCT00257166|Primary|Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4|YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.|Baseline, Week 4|Intent-to-treat (ITT): all randomized participants who had baseline measurements, took at least (>=) 1 dose of study medication (ziprasidone or placebo) and had >=1 post-baseline visit. Here, ‘n’ signifies those participants who were available for this measure at given time points for each group.||units on a scale||Standard Deviation|Mean
163063|NCT00257010|Secondary|Number of Headaches With Vomiting|Occurrence and intensity of vomiting post-dose of study medication. Vomiting is an act or instance of disgorging the contents of the stomach through the mouth also called emesis.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with vomiting|Participants||Number
163064|NCT00257010|Secondary|Number of Headaches With Nausea|Occurrence and intensity of nausea post-dose of study medication. Nausea is a feeling of sickness characterized by gastrointestinal distress and an urge to vomit.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with nausea|Participants||Number
163065|NCT00257010|Secondary|Number of Headaches With Phonophobia|Occurrence and intensity of phonophobia post-dose of study medication. Phonophobia is an abnormal sensitivity to or intolerance of noise.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with phonophobia|Participants||Number
163066|NCT00257010|Secondary|Number of Headaches With Photophobia|Occurrence and intensity of photophobia post-dose of study medication. Photophobia is an abnormal sensitivity to or intolerance of light, especially by the eyes.|Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches with photophobia|Participants||Number
163067|NCT00257010|Secondary|Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose|Headache pain relief is defined as a decrease in baseline pain intensity from either severe or moderate intensity to mild or no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain relief is defined as pain relief at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches|Participants||Number
163068|NCT00257010|Primary|Number of Pain Free Headaches at 2 and 24 Hours Post-Dose|Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.|2 hours and 24 hours post-dose|Intent-to-Treat (ITT) population is defined as all enrolled participants who took at least one dose of study medication and for whom at least one post-dose efficacy assessment was available.||Number of headaches|Participants||Number
163069|NCT00256997|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and End of Study (Month 24 or Early Termination [ET])|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Units on a scale||Standard Error|Mean
163070|NCT00256997|Secondary|Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24|"AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the value of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)”."|Baseline and Month 24|ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Units on a scale||Standard Deviation|Mean
163071|NCT00256997|Secondary|Number of Participants With Response to Resource Utilization Questionnaire (RUQ)|This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study [Visit 6, Month 24]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Participants|||Number
163635|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
163072|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Change (CGI-C)|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|End of Study (Month 24 or Early Withdrawal [EW])|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Participants|||Number
163073|NCT00256997|Secondary|Number of Participants With Clinical Global Impression of Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline and End of Study (Month 24 or Early Withdrawal [EW])|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||participants|||Number
163074|NCT00256997|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Month 24|ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Units on a scale||Standard Deviation|Mean
163075|NCT00256997|Secondary|Time in Symptomatic (Having Symptoms) Remission|Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration.|Baseline up to Month 24|Data for this outcome was not computed as it was not defined in terms of the formula for calculation and thus was not included in analysis plan.|||||
163076|NCT00256997|Secondary|Time to First Clinical Exacerbation|Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant’s schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Months||Standard Error|Mean
163077|NCT00256997|Secondary|Percentage of Participants Who Experienced a Clinical Exacerbation|Clinical exacerbation is defined as hospitalization because of participant’s schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Baseline up to Month 24|ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Percentage of participants|||Number
163078|NCT00256997|Primary|Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization|Clinical exacerbation is defined as hospitalization because of participant’s schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.|Month 3 up to Month 24|Intent-to-treat (ITT) population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data.||Percentage of participants|||Number
163079|NCT00256984|Secondary|SF-12 QOL Change (Mental Component) at 12 Months From Baseline|SF 12 change from baseline, mental component. The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-36 scores range from 0 (maximum impairment) to 100 (no impairment), the SF-12 scores range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 months|||units on a scale||Standard Deviation|Mean
163080|NCT00256984|Secondary|SF-12 QOL Change From Baseline (Physical Component)at 12 Months|The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in two six-item subscales, PCS (physical functioning) and MCS (emotional functioning). The SF-12 scores can range from 10 (maximum impairment) to 70 (no impairment). For this study, the endpoint is the percentage of change from baseline over 12 months post procedure.|Baseline, 12 Months|||units on a scale||Standard Deviation|Mean
163143|NCT00256204|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to Last Observed Value in the Placebo Phase|Subjects were assessed according to the United Parkinson's Disease Rating Scale UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|36 weeks|||Scores on a scale||Standard Deviation|Mean
163081|NCT00256984|Secondary|PAC QOL Patient Assessment of Constipation (Overall)|PAC-QOL is Patient Assessment of Constipation, Quality of Life. The instrument consists of 28 questions on a 0-4 scale. A lower score indicates better quality of life. The score is a number without units.Change from baseline in patient assessment of constipation in quality of life as measured by the PAC QOL instrument score. The questions are designed to measure the impact constipation has had on daily life during the week prior to the subject visit. Sizing was consistent with the primary outcome; analysis was per-protocol|Baseline, 12 months|Sizing consistent with primary outcome; analysis was Intent-to-Treat||units on a scale||Standard Deviation|Mean
163082|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 6 Months (0 is Worst Score, 24 is Best Score)|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|Baseline, 6 months post procedure|||percentage of change||Standard Deviation|Mean
163083|NCT00256984|Secondary|Maximum Change in Subject-reported Assessment of Symptom Severity and Frequency (PAC SYM).|Assessed as patient-reported assessment of symptom severity and frequency (PAC-SYM)associated with constipation. Patient response options are absent, mild, moderate, severe, and very severe.12 questions relate to severity, 8 questions relate to frequency of symptoms. The lower the score, the less severe the symptoms. Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 6 months|||units on a scale||Standard Deviation|Mean
163084|NCT00256984|Secondary|Percentage of Change in ODS Symptom Composite Score From Baseline at 1 Month Post Procedure|Percentage of change in Obstructive Defecation Syndrome (ODS) symptom composite score from baseline at 1 month post procedure. This score is based on a series of questions designed to understand the extent ODS effects an individual's daily lifestyle (0 is worst score, 24 is best score). Sizing consistent with primary outcome; analysis was per-protocol.|Baseline, 1 month post procedure|||percentage of change||Standard Deviation|Mean
163085|NCT00256984|Primary|Percentage of Change (Reduction) in Total ODS Symptom Composite Score From Baseline to One Year Post Procedure|The primary endpoint used to assess effectiveness of STARR for treatment of ODS was the percentage of change in total ODS symptom composite score (0=worst, 24=best) 1 year after completion of the procedure.|one year from Baseline|Per protocol||percentage of change||Standard Deviation|Mean
163086|NCT00256750|Secondary|Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
163087|NCT00256750|Secondary|Percent of Participants Surviving With a Functioning Graft|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Months 24, 36|All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N>=5. Otherwise exact method is used.||percentage of participants||95% Confidence Interval|Number
163088|NCT00256750|Secondary|Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24, and 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Error|Mean
163089|NCT00256750|Secondary|Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Baseline to Months 6, 12, 24,and 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Deviation|Mean
163110|NCT00256750|Secondary|Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12|The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163090|NCT00256750|Secondary|Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)|The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population.||Ridit score||Standard Error|Mean
163091|NCT00256750|Secondary|Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Deviation|Mean
163092|NCT00256750|Secondary|Mean Value of Physical and Mental Components Using SF-36 Questionnaire|SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.|Months 6, 12, 24, 36|All randomized and transplanted participants, intent to treat (ITT) population||units on a scale||Standard Deviation|Mean
163093|NCT00256750|Secondary|Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36|Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||participants|||Number
163094|NCT00256750|Secondary|Percent of Participants With Subclinical Rejection at Month 12|Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163095|NCT00256750|Secondary|Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12|Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine [SCr] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12||participants|||Number
163636|NCT00247273|Secondary|Change From Baseline in Serum CTX at Month 24, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 24|ITT||ng / mL||95% Confidence Interval|Least Squares Mean
163096|NCT00256750|Secondary|Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36|Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants|||Number
163097|NCT00256750|Secondary|Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36|The use of LDT (thymoglobulin or antithymocyte gamma globulin [ATGAM]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants|||Number
163098|NCT00256750|Secondary|Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12|A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met >= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output < 250 mL/12 hours, no significant improvement (< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.|Randomization to Month 12|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
163099|NCT00256750|Secondary|Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||participants|||Number
163100|NCT00256750|Secondary|Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36|Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.|Randomization to Month 36|All randomized and transplanted participants, intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
163101|NCT00256750|Secondary|Mean Value of Lipid Parameters|Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).|Months 12, 24, 36|All randomized and transplanted participants, intent-to-treat (ITT) population||mg/dL||Standard Deviation|Mean
163102|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hyperlipidemic Medication|This analysis is based on all participants who were followed up at least 1092 days after transplantation.|Month 36|All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.||percentage of participants||95% Confidence Interval|Number
163141|NCT00256243|Secondary|Microscopic Pathological Response Rate|pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.||Percent|||Number
163637|NCT00247273|Secondary|Percent Change From Baseline in Serum CTX at Month 6, ITT Population|Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
163103|NCT00256750|Secondary|Number of Participants With Antihyperlipidemic Medication by Intensity Level|An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.|Month 36|All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.||participants|||Number
163104|NCT00256750|Secondary|Percent of Participants With Controlled Dyslipidemia at Month 12|Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized and transplanted participants, intent-to-treat (ITT) population||percentage of participants||95% Confidence Interval|Number
163105|NCT00256750|Secondary|Percent of Participants With Prevalence of Dyslipidemia at Month 12|The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163106|NCT00256750|Secondary|Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12|Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs >= 500 milligrams/deciliter (mg/dL) [5.65 mmol/L]), hypercholesterolemia (LDL >= 100 mg/dL [2.59 mmol/L]), or elevated non-HDL (non-HDL >= 130 mg/dL [3.36 mmol/L]) in the presence of high TGs (TGs >= 200 mg/dL [2.26 mmol/L]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N >=5. Otherwise exact method is used.|Randomization to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163107|NCT00256750|Secondary|Percent of Participants With Prevalence of Controlled Hypertension at Month 12|The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163108|NCT00256750|Secondary|Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12|Controlled hypertension was defined as a SBP < 130 mm Hg and a DBP < 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP < 130 mm Hg and a DBP < 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension||percentage of participants||95% Confidence Interval|Number
163109|NCT00256750|Secondary|Mean Systolic Blood Pressure and Diastolic Blood Pressure|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Months 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mmHg||Standard Deviation|Mean
163142|NCT00256243|Primary|Clinical Response Rate|Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d’orange.|5 years|Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.||Percent by best modality|||Number
168724|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24||Month 24|||L||Standard Error|Mean
163111|NCT00256750|Secondary|Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12|The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163112|NCT00256750|Secondary|Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36|This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP < 130 mm Hg and a DBP < 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP|Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163113|NCT00256750|Secondary|Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36|The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is >=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)|Week 4 post-transplantation to Month 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163114|NCT00256750|Secondary|Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m^2|Month 6 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/Min/1.73 m^2||Standard Deviation|Mean
163115|NCT00256750|Secondary|Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation|Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant is female] x [1.180 if participant is black] x [BUN]^(-0.170) x [Alb]^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2|Months 6, 12, 24, 36|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/min/1.73 m^2||Standard Deviation|Mean
163116|NCT00256750|Secondary|Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163117|NCT00256750|Secondary|Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline|Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163118|NCT00256750|Secondary|Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Month 3 to Month 12; Month 3 to Month 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/min/1.73m^2||Standard Deviation|Mean
163177|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Total Bilirubin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
163119|NCT00256750|Secondary|Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84|Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.|Randomization to Month 84|All randomized, transplanted, and treated participants; intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
163120|NCT00256750|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36|"Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L).~Hemoglobin (low): <8.0 g/dL; Platelet count: <50*10^9 c/L; Leukocytes: <2*10^3 c/µL; Alkaline phosphatase (ALP): >5.0*ULN U/L; Alanine aminotransferase (ALT): >5.0*ULN U/L; Asparate aminotransferase (AST): >5.0*ULN U/L; Bilirubin Total: >3.0*ULN mg/dL; Creatinine: >3.0*ULN mg/dL; Calcium Total: low if <7.0 mg/dL or high if >12.5 mg/dL; Bicarbonate: <11.0 mEq/L; Potassium serum: low if <3.0 mEq/L or high if >6.0 mEq/L; Magnesium serum: low is <0.8 mEq/L or high if >2.46 mEq/L; Sodium serum: low if <130.0 mEq/L or high if >155.0 mEq/L; Phosphorus inorganic: <2.0 mg/dL; Albumin: <2 g/dL; Uric acid: >10 mg/dL; Protein urine: >=3+"|Baseline to Month 36|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population||participants|||Number
163121|NCT00256750|Secondary|Mean Blood Pressure at Month 84|Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.|Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).||mmHg||Standard Deviation|Mean
163122|NCT00256750|Secondary|Number of Participants With Adverse Events of Special Interest by Month 84|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)||participants|||Number
163123|NCT00256750|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to Month 84|All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)||participants|||Number
163124|NCT00256750|Secondary|Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12|Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.|Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.||percentage of participants||95% Confidence Interval|Number
163125|NCT00256750|Secondary|Mean Value of the Measured Glomerular Filtration Rate (mGFR)|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m^2.|Months 3, 12, 24|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||mL/min/1.73m^2||Standard Deviation|Mean
163178|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
163126|NCT00256750|Primary|Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12|Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
163127|NCT00256750|Primary|Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12|Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.|Month 12; Month 3 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component||percentage of participants||95% Confidence Interval|Number
163128|NCT00256750|Primary|Percent of Participants Surviving With a Functioning Graft by Month 12|Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.|Day 1 to Month 12|All randomized, transplanted, and treated participants; intent to treat (ITT) population||percentage of participants||95% Confidence Interval|Number
163129|NCT00256724|Secondary|Quantity of Fluid Administration||during 10 minutes of device use|||mL||Standard Deviation|Mean
163130|NCT00256724|Primary|Rise in Systolic Blood Pressure Over the First 10 Minutes of Use Compared to Baseline||every 2 minutes during 10 minutes of device use|||mm Hg||Standard Deviation|Mean
163131|NCT00256698|Secondary|Overall Survival (OS)|Overall survival is equivalent to time to death. Time from randomisation until the date of death|All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.|||months||Full Range|Median
163132|NCT00256698|Secondary|Time to Treatment Failure (TTF)|Time from randomisation until the date of discontinuation of randomised treatment for any reason|From randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
163133|NCT00256698|Secondary|Duration of Clinical Benefit (DoCB)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
163134|NCT00256698|Secondary|Duration of Response (DoR)|Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
163135|NCT00256698|Secondary|Percentage of Clinical Benefit Rate (CBR) Responders|No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||Percentage of participants|||Number
163136|NCT00256698|Secondary|Percentage of Evaluable Participants With Objective Response Rate (ORR)|No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)|RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||Percentage of evaluable participants|||Number
163137|NCT00256698|Primary|Time to Progression (TTP)|"RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve respond, stay the same stableor worsen progression during treatments."|RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009|||months||Full Range|Median
163138|NCT00256295|Secondary|Overall Survival and Time to Treatment Failure||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.|||||
163139|NCT00256295|Secondary|Frequency and Severity of Toxicities||5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.|||||
163140|NCT00256295|Primary|Overall Response Rate (Complete and Partial Response)|"Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline.~Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline."|5 years|No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.|||||
163144|NCT00256204|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline|The primary efficacy endpoint was defined as the change in Total UPDRS from Baseline. Subjects were assessed according to the United Parkinson's Disease Rating Scale (UPDRS,(version 3;) Parts I and II are historical data and are designed to rate mentation, behavior and mood; Part III is done as a motor examination at the time of a visit. The UPDRS measures patient status on a scale 0, which is normal or none, to 4, which is severe or the worst scenario.|12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w|||Scores on a scale||Standard Deviation|Mean
163145|NCT00255970|Secondary|Mobility Index|"Tooth mobility was recorded using Miller's Index:~— up to 1 mm of movement in a horizontal direction~— greater than 1 mm of movement in a horizontal direction~— excessive horizontal movement and vertical movement. Manual evaluation of mobility was carried out clinically using the handles of two instruments to move the teeth buccally and lingually and note their movement."|6 months|A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study. The power analysis had been computed for a threshold of 0.05 with a power of 0.8.||Units on a scale||Standard Deviation|Mean
163146|NCT00255970|Secondary|Bleeding on Probing|"The variable measured the presence of bleeding when the osseus defect was probed. The presence and character of gingival bleeding will be determined by gently probing to the base of the pockets.~0 - No bleeding.~1 - Bleeding when probing."|6 months|The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||Units on a scale||Standard Deviation|Mean
163147|NCT00255970|Secondary|Plaque Index|"0- No plaque~A film of plaque adhering to gingival margin & adjacent area of tooth~Moderate accumulation of soft deposits, visible with the naked eye~Abundance of soft matter Each gingival region of the individual tooth will be scored 0-3 The scores from the 6 areas of the tooth are averaged to give the plaque index for the tooth."|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm||Categorical index score||Standard Deviation|Mean
163148|NCT00255970|Secondary|Gingival Index|"Scores:~0 Normal gingiva~Mild inflammation~Moderate inflammation~Severe inflammation Gingival units (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of each tooth were scored 0-3. Scores from the 6 areas of the tooth were added and divided by 6 to give the gingival index for the entire tooth."|6 months|As stated in the protocol, the power analysis (threshold=0.05, power>0.8) noted 18 subjects would be needed per group.||Units on a scale||Standard Deviation|Mean
163149|NCT00255970|Primary|Recession|CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.|6 months|The number of participants to be analyzed was based on a power analysis, using a threshold of 0.05 with a power of 0.8. The power analysis indicated 18 participants were needed in each arm||mm||Standard Deviation|Mean
163150|NCT00255970|Primary|Clinical Attachment Level|The amount of space between attached periodontal tissues and a fixed point, usually the cementoenamel junction. A measurement used to assess the stability of attachment as part of a periodontal maintenance program.|6 months|||mm||Standard Deviation|Mean
163151|NCT00255970|Primary|Change in Probing Depth|This is the distance, measured in millimeters (mm) from the gingival margin to the maximal penetration of the probe tip. The measures were made at baseline and then at 6 months after treatment.|baseline and then at 6 months|||mm||Standard Deviation|Mean
163152|NCT00255840|Primary|Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).|Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.|96 weeks|The primary analysis was an intention-to-treat analysis of any treatment failure with use of Cox proportional hazards regression.||Percentage of participants||95% Confidence Interval|Number
163153|NCT00255840|Secondary|To Estimate the Total and Incremental Costs, From the Provider and Societal Perspectives, of the Two Approaches (the Primary Health Care Sister and Doctor) to the Provision of Antiretrovirals in Primary Health Care Services in Each Study Site.||Throughout study||||||
163154|NCT00255840|Secondary|To Compare the Overall Clinical Safety of Antiretroviral Therapy, as Measured by the Occurrence of Clinical and Laboratory Grade 3 and 4 Adverse Events, Between Primary Health Care Monitoring Arms.||Throughout study||||||
163155|NCT00255840|Secondary|Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure||Throughout the study||||||
163156|NCT00255840|Secondary|To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.||Throughout study||||||
163157|NCT00255723|Primary|Overall Objective Response|"Overall objective response to therapy Complete remission/unconfirmed (CRu)~This includes patients who meet criteria for CR with the following exceptions:~1. A residual lymph node mass > 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR)~Any decrease in lymph nodes and nodal-based masses~Any decrease in PET avidity (however, residual FDG uptake is present)~Involving organs involved prior to therapy must have diminished in size.~No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease~1. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy"|3 years|||participants|||Number
163158|NCT00255684|Secondary|Number of Participants Who Developed Acute Graft Versus Host Disease||3 months|||participants|||Number
163159|NCT00255684|Primary|Number of Participants Who Survived 100 Days or Longer||100 days|||participants|||Number
163160|NCT00255190|Primary|Changes From Baseline to Final Visit in Fundus Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit fundus biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days postdosing.||subjects|||Number
163161|NCT00255190|Primary|Changes From Baseline to Final Visit in Antrum Biopsy Results|Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.|Baseline and Final Visit (up to 12 months)|All subjects with Final Visit antrum biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days post-dosing.||subjects|||Number
163162|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163163|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163164|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163165|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163166|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-SYM Total Score|Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163167|NCT00255190|Secondary|Mean Change From Baseline to Month 12 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 12|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163168|NCT00255190|Secondary|Mean Change From Baseline to Month 9 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 9|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163169|NCT00255190|Secondary|Mean Change From Baseline to Month 6 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 6|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163170|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Pulse Rate||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||beats per minute||Standard Deviation|Mean
163171|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Diastolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mm Hg||Standard Deviation|Mean
163172|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Systolic Blood Pressure||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mm Hg||Standard Deviation|Mean
163173|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Serum Gastrin Levels||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||pg/mL||Standard Deviation|Mean
163174|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||U/L||Standard Deviation|Mean
163175|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||U/L||Standard Deviation|Mean
163176|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||U/L||Standard Deviation|Mean
163179|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Calcium Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
163180|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Creatinine Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
163181|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||mg/dL||Standard Deviation|Mean
163182|NCT00255190|Primary|Mean Change From Baseline to Month 12 for White Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||White Blood Cell count x10 to the 3/mcL||Standard Deviation|Mean
163183|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Platelet Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||Platelet Count x10 to the 3/mcL||Standard Deviation|Mean
163184|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||g/dL||Standard Deviation|Mean
163185|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Red Blood Cell Count Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||Red Blood Cell count x10 to the 6/μL||Standard Deviation|Mean
163186|NCT00255190|Secondary|Mean Change From Baseline to Month 3 for PAGI-QOL Total Score|Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 3|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.||score on a scale||Standard Deviation|Mean
163187|NCT00255190|Secondary|Mean Change From Baseline to Month 1 for PAGI-QOL Total Score|Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.|Baseline and Month 1|All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the Patient Assessment of Upper Gastrointestinal Disorders (PAGI) analyses.||score on a scale||Standard Deviation|Mean
163188|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hematocrit Values|Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.|Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||percentage||Standard Deviation|Mean
163189|NCT00255190|Primary|Mean Change From Baseline to Month 12 for Hemoglobin Values||Baseline and Month 12|All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.||g/dL||Standard Deviation|Mean
163190|NCT00255177|Primary|Mean Log Change in Viral Load From Baseline (Day 1) to Day 28|Mean log change in HCV RNA viral load (significant reduction is considered >0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint|Baseline (Day 1) to Day 28|||copies/mL on log scale||Standard Deviation|Log Mean
163191|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
163192|NCT00255164|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
163193|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.||Percentage of Subjects|||Number
163194|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
163195|NCT00255164|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
163196|NCT00255164|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.||Percentage of Subjects|||Number
163197|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
163198|NCT00255151|Secondary|Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|6 months|The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
163199|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method|Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.|6 months|Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.||Percentage of Subjects|||Number
163200|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Standard Deviation|Mean
163201|NCT00255151|Secondary|Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.|6 months|The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.||Percentage of Days||Inter-Quartile Range|Median
163202|NCT00255151|Primary|Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.|Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.|6 months|The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of >7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.||Percentage of Subjects|||Number
163203|NCT00255125|Secondary|Molecular Effects of Soy Supplementation Compared to Placebo.|Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm.|One year||||||
163204|NCT00255125|Secondary|2.Effect of Soy Isoflavones on Estrogen Receptor Status.|Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results.|One year||||||
163205|NCT00255125|Primary|1.Effect of Soy Isoflavones on Serum Testosterone Levels.|Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.|Two weeks|||ng/ml||80% Confidence Interval|Mean
163206|NCT00255047|Primary|Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.||30 Days post-dose 3 vaccination.|Geometric mean titers were evaluated in the per-protocol immunogenicity population||Titers||95% Confidence Interval|Geometric Mean
163207|NCT00255047|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3|Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.|7 days post-vaccination 3|Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population||Participants|||Number
163208|NCT00255047|Primary|Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)||30 Days post-dose 3 vaccination|Four-fold rise titers (seroconversion) were evaluated in the per-protocol population||Percentage of participants|||Number
163209|NCT00255047|Primary|Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.|Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.|30 Days post-dose 3 vaccination|The vaccine response to pertussis antigens were determined in the per-protocol population.||Percentage of Participants|||Number
163210|NCT00255034|Primary|Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy|No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.|24 weeks after completion of either up to 24 or 48 weeks of therapy|"Data were missing for 1 subject in the 48 weeks of therapy treatment arm."||Participants|||Number
164940|NCT00218335|Primary|Any Sex Risk||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
163211|NCT00255008|Primary|Number of Subjects Who Achieved a Sustained Virologic Response (SVR)|SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed.|24 weeks after completion of either up to 24 or 48 weeks of therapy|The study was terminated early due to slow enrollment. The primary outcome measure should be assessed with caution. No data was available at 24 weeks after therapy for the Genotype 1 Caucasian treatment group.||Participants|||Number
163212|NCT00254995|Other Pre-specified|Summary of Reported Pregnancy Outcomes in Menactra Vaccine Recipients Pregnant at or Within 28 Days After Vaccination|Only persons who received Menactra vaccine during the study period were included in this outcome.|Day 0 up to Determination of Pregnancy Outcome|Only persons who received Menactra vaccine during the study period were included in the analysis. There were no control group analysis because the threshold of 25 pregnancies with known were not achieved at the time the surveillance was concluded.||Paticipants|||Number
163213|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination – Hospital Setting – All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 doses|||Number
163214|NCT00254995|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination – ER Setting – All Ages Combined.|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only all persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 doses|||Number
163215|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
163216|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Reduced Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
163217|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – By Age Categories – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as (C) for pre-specified adverse events, (H) for hospital, (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine and their age-matched controls during the study period were included in the analysis.||Events per 1,000 person-months|||Number
163218|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons – By Age Categories – Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months for each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
163219|NCT00254995|Other Pre-specified|Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls – All Ages Combined – Long-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in the 6-month surveillance period. For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in age-matched controls. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
163293|NCT00253435|Secondary|Engraftment DLT|"• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:~neutrophils (ANC) < 500/μL by day 28 post transplant, or~platelets < 20,000 /μL by day 56 post transplant, or~if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets."|From treatment start until 60 days post stem cell infusion|All patients who began treatment||participants|||Number
163220|NCT00254995|Primary|Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined – Short-Term Passive Surveillance|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.|Day 0 up to Day 60 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.||Events per 1,000 person-months|||Number
163221|NCT00254982|Primary|Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score|PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).|Baseline and Week 22|Per Protocol Population - All participants in the intent to treat population who completed the study without major protocol violations. For missing data, the last observation carried forward (LOCF) was applied.||Proportion of participants|||Number
163222|NCT00253747|Secondary|Point-prevalence Abstinence|A logistic regression including site and treatment group will be used to model rates of achieving point prevalence abstinence as assessed at the final visit of the O-MPH/P-Stnd Smoking Tx phase. Point prevalence abstinence was defined as not smoking in the previous seven days based on self-report using the TLFB method and confirmed with a Carbon Monoxide (CO) level <8 ppm.|Week 11|Evaluable population determined as for primary outcome.||participants|||Number
163223|NCT00253747|Secondary|Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale|A Generalized Estimating Equations(GEE)model which included treatment group, week, site, and treatment by week and site by week interaction effects was used to compare the groups on the DSM-IV ADHD total severity score (18 domains score at severity levels of 0[none]-3[severe]; maximum score 54) as measured at screening/baseline and study weeks 1-4 using the the interviewer-administered DSM-IV checklist and by the severity portion of the National Institute of Mental Health Clinical Global Impression (CGI) scale to rate the severity of the participant’s ADHD symptoms. A single severity score ranging from 1 to 7 is yielded by the CGI severity scale.|Baseline and Study weeks 1,4,7,9,11|Evaluable participants determined using criteria for same in the primary outcome.||DSM IV ADHD Score||Standard Deviation|Mean
163224|NCT00253747|Primary|Prolonged Abstinence|The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. “Smoking days” were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports.|Weeks 7-10|Randomized participants who complete at least two visits during the first four weeks following randomization, who reach the full dose of OROS-MPH /Placebo, who have a OROS-MPH /placebo medication compliance rate of at least 75% each week for study weeks 4 through 10, and who attend at least one meeting after initiating the nicotine patch.||participants|||Number
163225|NCT00253643|Primary|Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention|Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.|End of study|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.||%age of cells & nuclei stained||Full Range|Median
163226|NCT00253643|Primary|Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)|Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.|Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)|Number of participants for recruitment was based on power calculations. All participants consented and randomized were included in analyses. Analysis was intention to treat. No imputations for missing data were conducted.||units on a scale||Standard Deviation|Mean
163227|NCT00254592|Primary|Overall Clinical Response to the Dose Dense Regimen||3 years|||participants|||Number
163228|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score|1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at TOC will be imputed by carrying forward the last post-baseline observation; Domain score is calculated by deriving the simple average of the relevant items, both mental state items must be non-missing to derive a mental state score||Score on Scale||Standard Error|Least Squares Mean
163229|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score|1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF-missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score||Score on Scale||Standard Error|Least Squares Mean
163516|NCT00249249|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change in total cholesterol from baseline to Week 12|Baseline to 12 Weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||percent change||Standard Deviation|Mean
163230|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score|1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale – 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, LOCF - missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score||Score on Scale||Standard Error|Least Squares Mean
163231|NCT00254566|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score|CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline|Test of Cure (TOC) Visit (Day 12-19)|Analysis on Full Analysis Set, Last Observation Carried Forward (LOCF)-missing values at TOC visit will be imputed by carrying forward the last post-baseline observation; total score calculated by deriving the simple average of relevant items, total score is set to missing if 1 or more domain scales cannot be derived.||Score on Scale||Standard Error|Least Squares Mean
163232|NCT00254566|Secondary|Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence|Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.|Number of Days|Time to AECB recurrence will be analyzed for the FAS using survival analysis methods to account for censored observations. Subjects are censored at the date last known to have not experienced a recurrence. Median time to recurrence will be estimated using the Kaplan-Meier method.||Days|||Number
163233|NCT00254566|Secondary|Percentage of Bacteriologic Response at Test of Cure Visit|Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline|Test of Cure (TOC) Visit (Day 12-19)|Bacteriologic per protocol set is compromised of subjects from the Clinical Per Protocol set with a baseline bacterial pathogen. The number of participants is the number of unique pathogens identified at baseline.||Percent|||Number
163234|NCT00254566|Secondary|Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)|Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinically eligible compromised of subjects from FAS with diagnosis of chronic bronchitis, clinical evidence of AECB based on S&S, & a neg chest radiograph for pneumonia based on radiologist opinion||Percent|||Number
163235|NCT00254566|Secondary|Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)|Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Full Analysis Set (FAS) is all randomized subjects who received at least 1 dose of study medication.||Percent|||Number
163236|NCT00254566|Primary|Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)|Cure=Signs&symptoms(S&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S&S of acute infection persisted/worsened,new clinical S&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub|Test of Cure (TOC) Visit (Day 12-19)|Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.||percent|||Number
163237|NCT00254540|Secondary|Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.~n=Number of subjects with analyzable data."||pg/mL||Full Range|Median
163238|NCT00254540|Secondary|Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)|Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis.~n=Number of subjects with analyzable data."||pg/mL||Full Range|Median
163239|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.~n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
163240|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population|"SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.~The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject."|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
163241|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3.~n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
163242|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population|SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
163243|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data.~Descriptive statistics on Cycle 2 Day 1 and Cycle 3 Day 28 were not calculated because number of subjects with analyzable data was less than 3."||ng/mL||Full Range|Median
163244|NCT00254540|Secondary|Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population|Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration|Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3|"All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis.~n=Number of subjects with analyzable data."||ng/mL||Full Range|Median
163245|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)|"Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline.~The VAS is a self-completed scale designed to rate the subject’s current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n=Number of subjects with analyzable data."||Scores on a scale||Standard Deviation|Mean
163246|NCT00254540|Secondary|Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score|Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.|Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4|"Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.~n=Number of subjects with analyzable data."||Scores on a scale||Standard Deviation|Mean
163247|NCT00254540|Secondary|Overall Survival Time|Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.|once year. Up to 3 years after the completion of subject registration.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||Full Range|Median
163248|NCT00254540|Secondary|Time to Tumor Response (TTR)|Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.||Weeks||Full Range|Median
163249|NCT00254540|Secondary|Duration of Response (DR)|Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.||Weeks||Full Range|Median
163250|NCT00254540|Secondary|Time To Tumor Progression (TTP)|Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||Full Range|Median
163251|NCT00254540|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.|Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||Weeks||Full Range|Median
163517|NCT00249249|Primary|Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12||Baseline to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||percent change||Standard Deviation|Mean
163252|NCT00254540|Primary|Number of Subjects With Objective Response|Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycles 1-4|Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.||participants|||Number
163253|NCT00254501|Secondary|Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months|"Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):~Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment~Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers.~Changes from baseline to 12 months for understanding of diabetes. This is a single question: How would you rate your understanding of diabetes and its treatment? which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent)."|From baseline to 12 months|The number of participants reported for each outcome reflects those participants who completed both baseline and 12-month surveys.||units on a scale||95% Confidence Interval|Mean
163254|NCT00254501|Secondary|Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months|"Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:~Total cost of care~Costs of diabetes medications~Costs of diabetes supplies"|baseline to 12 months|Changes in claims-based data from baseline to 12 months among patients with at least one diabetes-related claim at baseline.||US dollars||95% Confidence Interval|Mean
163255|NCT00254501|Secondary|Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides|"Changes from baseline in LDL, HDL, total cholesterol, triglycerides.~Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):~LDL~HDL~Total cholesterol~Triglycerides"|baseline and 12 months|The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.||mg/dl||95% Confidence Interval|Mean
163256|NCT00254501|Primary|Change in Hemoglobin A-1C From Baseline|Compare changes in Hemoglobin A-1C from baseline between the two groups.|baseline and 12 months|Specific employers were recruited and offered waiver of out-of-pocket costs for diabetes-related care to their employees to participate in the study. The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.||percentage of glycolsylated hemoglobin||Standard Deviation|Mean
163257|NCT00254462|Secondary|Change in Total ADHD-IV Teacher|Measures 18 symptoms of ADHD. Each symptom rated 0-3, for a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.|Measured at baseline and at Week 8. Later time point is subtracted from earlier time point.|||units on a scale||Standard Error|Mean
163258|NCT00254462|Primary|Change in ADHD-IV Rating Scale Total Score|"Measures 18 symptoms of attention deficit hyperactivity disorder (ADHD). Each symptom rated 0-3, for a minimum total score of 0, and a maximum total score of 54 for the scale. A higher score reflects more severe symptomatology.~The inattentive subscale and the hyperactive/impulsive subscale each has a minimum score of 0 and maximum score of 27."|Measured at baseline and at Week 8. These are the only two timepoints calculated, later timepoint subtracted from earlier timepoint.|||units on a scale||Standard Error|Mean
163259|NCT00254293|Secondary|Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies|Assessment of positive antibody response based upon analysis using a validated enzyme-linked immunosorbent assay (ELISA) with a cut-off value. CTLA4 is a protein receptor that downregulates the immune system. Short Term (ST) period was initial 12 Weeks of the study. Overall LTE includes both the variable and fixed abatacept dosing periods and was from the end of the ST period (Day 85) up to 168 days post last dose (treatment in LTE ranged from 4.4 to 74.2 months. Data in the ST period are summarized by the treatment the participants actually received, while the LT period data are summarized by treatment the participant was randomized to receive.|ST: Day 1 to Day 85; LTE: Day 85 to 168 days post last dose|In the ST period, only subjects treated with abatacept (51) were evaluated for antibodies. In LTE, 61 participants were analyzed for anti-abatacept antibodies, and 62 participants were analyzed for CTLA4-T antibodies. Participants were analyzed during treatment and post-treatment (28, 56, 85, and 168 days post-treatment).||participants|||Number
163260|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)|On Day 85 participants rolled over into the LTE with variable dose phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight. This summary includes AEs reported during entire LTE treatment plus 56 days post last dose; includes all deaths reported during the LTE including those that occurred greater than 56 days after last dose. MedDRA version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 533 to 56 Days Post last dose|total number of participants in the Long Term Extension Period.||participants|||Number
163294|NCT00253435|Secondary|Event-free Survival (EFS) at 3 Years|EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.|3 years since start of treatment|Estimated probability of 3-year progression free survival for all patients enrolled in each risk group.||Estimated probability|||Number
163261|NCT00254293|Secondary|Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. Heart Rate was reported in beats per minute (bpm). In no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 65 had results at screening and 53 had results at Discharge (Day 85) for Heart Rate.||bpm||Standard Deviation|Mean
163262|NCT00254293|Primary|Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)|LTE period with variable abatacept dosing starting on Day 85 and continuing until Day 533 when LTE fixed dosing started. AEs of special interest: infection and/or infestation; neoplasms (malignant); pre-specified autoimmune disorder; infusional AEs (peri-infusional: pre-specified AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: pre-specified AEs occurring during the first hour after the start of the IV loading dose; systemic injection site reactions (SIR): pre-specified AEs for SIR; local injection site reaction: pre-specified AEs for local site reaction. Data are presented by treatment the participant was randomized to and not what they actually received.|Day 85 to Day 533|All 63 participants who completed the ST period enrolled into the LTE variable dosing period and were analyzed.||participants|||Number
163263|NCT00254293|Secondary|Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. QT interval, PR interval and QRW Width were reported in milliseconds (msec). If no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Screening to Day 85 (or early termination)|A total of 68 participants were treated with abatacept or placebo: 66 had results at screening and 52 had results at Discharge (Day 85) for QT interval and QRS Width; 65 and 51 participants had PR interval results at Screening and Discharge (Day 85), respectively.||msec||Standard Deviation|Mean
163264|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Pulse rate was taken while participant was seated. Pulse rate was recorded during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, vital signs were recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Pulse rate measured in beats/min (bpm). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28, 6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively||bpm||Standard Deviation|Mean
163265|NCT00254293|Secondary|Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS|Blood pressure (systolic and diastolic) was recorded while the participant was seated during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, blood pressure was recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Blood pressure was measured in millimeters of mercury (mm Hg). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28,6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively||mm Hg||Standard Deviation|Mean
163266|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85|Screening, BL, Days 15, 29, 57, 85 or discharge. Upper limit of normal (ULN). CTC grade (Gr): Alanine transaminase Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase Gr 1: >ULN to 2.5*ULN; Gr 2:>2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. G-Glutamyl Transferase (U/L) Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Alkaline phosphatase (U/L) Gr 1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4: >20.0*ULN; creatinine (mg/dL) Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 6.0*ULN; Gr 4: >10.0*ULN. Albumin (g/dL) Gr 1:<LLN to 3.0; Gr 2:<3.0 to 2.0; Gr 3: <2.0. Uric Acid (mg/dL)Gr 1: >1.0 x ULN to 10.0; Gr 4: >10.0. Sodium (mEq/L) Gr 1: >ULN to 150; Gr 2: >150 to 155; Gr 3: >155 to 160; Gr 4: > 160. Potassium (mEq/L) Gr 1: >ULN to 5.5; Gr 2: >5.5 to 6.0; Gr 3: >6.0 to 7.0; Gr 4: >7.0. Data presented by treatment participant actually received.|Day 1 to Day 85 (or early termination)|All participants treated with abatacept or placebo in the short term period. Participant is counted once in total but could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)||participants|||Number
163292|NCT00253435|Secondary|Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS|"Dose limiting veno-occlusive disease (VOD) defined as:~the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin > grade 1, PLUS~the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution"|Between start of MIBG treatment and 60 days post stem cell infusion|All patients who began treatment||participants|||Number
163534|NCT00248807|Primary|Systolic Blood Pressure|Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention|acute testing|convenience sample||mmHg||Standard Deviation|Mean
163267|NCT00254293|Secondary|Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)|Blood samples were obtained: At screening, within 24 hours prior to study drug administration on Day 1, on Days 15, 29, 57 and at study discharge. Baseline (BL) defined as Day 1 prior to treatment. Common toxicity criteria (CTC), Version 3 used to assess parameters. lower limit of normal (LLN). ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Lymphocytes Gr 1: <LLN to 3.0, Gr 2: 2.0 < 3.0, Gr 3: 1.0 to < 2.0, Gr 4; < 1.0. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Hematocrit (%): <0.75*pre-treatment. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All participants treated with either abatacept or placebo. Participant counted once in total for each arm but participant could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)||participants|||Number
163268|NCT00254293|Secondary|Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration|Serum samples were obtained on Days 1, 8, 15, 29, 57 and day of discharge (Day 85 or earlier) for determination of presence of rheumatoid factor (RF). Baseline was defined as Day 1 to calculate percent change. Lower limit of quantitation (LLQ) was 5 Units/milliliter (U/mL). Values below LLQ were set to 2.5 U/mL. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|Analysis set included all available data from participants who received abatacept or placebo. For RF analysis in Group 1 Day 1/Day 85 number of participants = 7/7; Group 2 = 3/3; Group 3 = 29/29; Group 4 = 6/6; Group 5 = 5/5; Placebo = 17/15 participants.||percentage of change from baseline||Standard Deviation|Mean
163269|NCT00254293|Secondary|Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks|AEs of special interest: infection and/or infestation; neoplasms (benign, malignant, unspecified; autoimmune disorder; infusional AEs (peri-infusional: AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: AEs occurring during the first hour after the start of the IV loading dose; injection site AEs: AEs occurring at the site of the SC injection. Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|All subjects treated were analyzed for safety.||participants|||Number
163270|NCT00254293|Secondary|Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo|Number of Participants with Adverse events (AEs), Serious AEs, discontinuations due to AEs, or Deaths occurring while participant was on treatment from Day 1 (treatment) to Day 85 or early termination from the study. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 1 to Day 85 (or early termination)|||participants|||Number
163271|NCT00254293|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)|AEs during variable dose phase of LTE + 56 days post last dose in the variable dose phase or start of the fixed dose phase, which ever came first; includes deaths reported during the variable dose phase including those that occurred greater than 56 days after last dose. Medical Dictionary for Regulatory Activities (MedDRA) version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug. Data presented by treatment the participant was randomized to and not what they actually received.|Day 85 to 56 days post last dose|Participants included those that rolled over into the LTE, receiving variable SC dosing of abatacept in the Variable Dose Period.||participants|||Number
163272|NCT00254293|Secondary|Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS|The steady-state pharmacokinetic parameter AUC(TAU) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78 (TAU=7 days). Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001; Upper limit of quantification (ULOQ) was 0.030. AUC(TAU) measured in in micrograms*hours per milliliter (µg*h/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available.||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
163273|NCT00254293|Secondary|Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS|Peak serum concentration (Cmax) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78. Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001, Upper limit of quantification (ULOQ) was 0.030. Cmax measured in micrograms per milliliter(µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Day 71 to Day 78|Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available||µg/mL||Geometric Coefficient of Variation|Geometric Mean
163553|NCT00248651|Primary|Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment|The first two weeks of treatment were excluded to allow for establishment of steady state drug levels.|3 weeks through 12 weeks|The intent-to-treat analysis included all randomized subjects.||percentage of participants|||Number
163274|NCT00254293|Primary|Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)|Participants received abatacept while also receiving DMARDS over a short term (ST) 12 Week period. To eliminate contribution from the IV loading dose of abatacept during the short term study period, Cmin values were selected from Days 71 to 85, when contribution from IV was negligible. Minimum trough serum concentration of abatacept (Cmin) was measured in micrograms/milliliter (µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.|Days 71 to 85|50 of the 51 abatacept-treated subjects were included. One subject who discontinued after receiving only Day 1 dosing was not included in this analysis.||µg/mL||Geometric Coefficient of Variation|Geometric Mean
163275|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 2-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|24 months after registered.|Per protocol population||Probability of Progression-free Survival||95% Confidence Interval|Number
163276|NCT00254163|Secondary|Progression-free Survival (PFS) Rate at 1-year|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date|12 months after registered.|Per protocol population||probability of Progression-free Survival||95% Confidence Interval|Number
163277|NCT00254163|Secondary|Objective Remission Rate (ORR)|"Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.~≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.~≥50% reduction in lymphadenopathy.~≥50% reduction in the size of the liver and/or spleen.~Polymorphonuclear leukocytes ≥ 1,500/mm^3 or 50% improvement over baseline.~Platelets >100,000/mm^3 or 50% improvement over baseline.~Hemoglobin >11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants||95% Confidence Interval|Number
163278|NCT00254163|Secondary|Complete Remission (CR)|"Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.~Complete remission (CR) requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be <1 cm.~No evidence of hepatomegaly or splenomegaly.~Absence of constitutional symptoms.~Normal CBC as exhibited by:~Polymorphonuclear leukocytes ≥ 1,500/mm^3~Platelets > 100,000/mm^3~Hemoglobin > 11.0 g/dL (untransfused)~Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.~Lymphoid nodules should be absent."|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants||95% Confidence Interval|Number
163279|NCT00254163|Secondary|Mean Absolute Neutrophil Count (ANC) at Post-treatment|mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment|2 months post-treatment|Per protocol population||10^3 cells/mm^3||Standard Deviation|Mean
163280|NCT00254163|Secondary|Hematologic Recovery|defined as Hb >11g/dL and a platelet count >100 × 10^3/mm^3|2 months post-treatment|Per protocol population||percentage of participants||95% Confidence Interval|Number
163281|NCT00254163|Secondary|Percentage of Patients Hospitalized|Percentage of patients who were hospitalized due to any reasons during the study period.|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants|||Number
163282|NCT00254163|Secondary|Infective Event Rate|infective events=temperature >101 without symptoms or temp <101 with symptoms|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of infective events|||Number
163283|NCT00254163|Primary|Infection Rate|infection=febrile events requiring treatment|6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity|Per protocol population||percentage of participants||95% Confidence Interval|Number
163284|NCT00254072|Primary|Number of Participants With Postoperative Gastrointestinal Hemorrhage||30 days|||participants|||Number
163285|NCT00253981|Primary|Visual Analog Scale|Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.|4 weeks||||||
163286|NCT00253890|Primary|Sleep Quality, as Measured by Total Sleep Time|Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.|Baseline to 1-month|Intent to Treat||minutes||Standard Deviation|Mean
163287|NCT00253513|Secondary|Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival.||One year|||participants|||Number
163288|NCT00253513|Primary|Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)|NRM (Non relapse mortality) - death not attributed to the primary cancer.|200 days|||percent of participants||95% Confidence Interval|Number
163289|NCT00253513|Primary|Number of Patients Experiencing Graft Failure|Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither.|42 days|For graft failure 2 of the 60 patients were not evaluable because they exeperienced another event (relapsed) before they could be evaluable for graft failure.||participants|||Number
163290|NCT00253513|Primary|Number of Patients Experiencing Regimen-related Toxicity Events in Study Population|Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal|34 days and 2 years|||participants|||Number
163291|NCT00253448|Primary|Overall Survival After Treatment|Followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter for at least 5 years|Minimum of 5 years.|||months||95% Confidence Interval|Median
163295|NCT00253435|Primary|Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion|Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).|Response assessed 60 days post stem cell infusion|One patient in the Poor Risk Cohort underwent surgery for resection (of his only measureable lesion) prior to post-treatment assessment and is not evaluable for response.||participants|||Number
163296|NCT00253370|Secondary|Overall Survival (OS)|Overall survival was defined as the time from registration to death from any cause.|Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry.|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.||Months||90% Confidence Interval|Median
163297|NCT00253370|Secondary|Progression-free Survival (PFS)|"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions."|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.||Months||90% Confidence Interval|Median
163298|NCT00253370|Primary|The Proportion of Patients With Objective Response (Complete Response or Partial Response)|Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 6 weeks until disease progression or up to 3 years|All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.||Proportion of patients||90% Confidence Interval|Number
163299|NCT00253019|Primary|Continuation Rates|We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.|3 months|It was a convenience sample.||participants|||Number
163300|NCT00252967|Secondary|Comparison of Tumor Necrosis Factor Alpha Values||Baseline and 30 days|||ng/mL||Inter-Quartile Range|Median
163301|NCT00252967|Secondary|Comparison of High Sensitivity C-reactive Protein||Baseline and 30 days|||mg/L||Inter-Quartile Range|Median
163302|NCT00252967|Secondary|Comparison of Interleukin-1 Values||Baseline and 30 days|||ng/mL||Inter-Quartile Range|Median
163303|NCT00252967|Secondary|Comparison of Interleukin-6 Values||Baseline and 30 days|||ng/mL||Inter-Quartile Range|Median
163304|NCT00252967|Secondary|Comparison of Isoprostanes Values||Baseline and 30 days|||pg/mL||Inter-Quartile Range|Median
163305|NCT00252967|Secondary|Comparison of Derivatives of Reactive Oxygen Metabolites Values||Baseline and 30 days|||Carr||Inter-Quartile Range|Median
163306|NCT00252967|Secondary|Comparison of Redox Potential for Glutathione Values||Baseline and 30 days|||mV||Inter-Quartile Range|Median
163307|NCT00252967|Secondary|Comparison of Redox Potential for Cysteine Values||Baseline and 30 days|||mV||Inter-Quartile Range|Median
163308|NCT00252967|Primary|Time of Atrial Fibrillation Recurrence||Upon recurrence, up to 12 months|||days||Inter-Quartile Range|Median
163309|NCT00252733|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
163310|NCT00252733|Primary|Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.|Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
163311|NCT00252720|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log (UAER) over time (post-randimisation, yearly assessments) for each patient|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randimized patients with any post-randomization data.||log (µg/min)/year||95% Confidence Interval|Least Squares Mean
163312|NCT00252720|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population whick includes all randomized patients with any post-randomization data.||Participants|||Number
163313|NCT00252720|Secondary|Number of Participants With a Regression of Diabetic Retinopathy.|Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to the end of the study, i.e., 5 years|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
163554|NCT00248638|Secondary|Heat Shock Proteins Levels||28 days||||||
163555|NCT00248638|Secondary|Gluthatione Levels||28 days||||||
163314|NCT00252720|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention to Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
163315|NCT00252694|Secondary|Rate of Change in Urinary Albumin Excretion Rate (UAER).|An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.|From Baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||log (µg/min)/1000 year||95% Confidence Interval|Least Squares Mean
163316|NCT00252694|Secondary|Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).|Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
163317|NCT00252694|Secondary|Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).|From baseline to end of study, i.e. 5 years.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
163318|NCT00252694|Primary|Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale|3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.|From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.|The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.||Participants|||Number
163319|NCT00252629|Primary|The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.|"IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans.~We expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans."|On a full night polysomnogram|||percentage of flow limited breaths||Standard Deviation|Mean
163320|NCT00252629|Secondary|Change of Cognitive Dysfunction|Cognition dysfunction- increasing difficulty with memory, ability to think, and ability to concentrate was rated 0-10 daily by visual analogue scale, where 0 no problem and 10=severe problems.|3 weeks treatment with either therapeutic or sham CPAP|||units on a scale||Standard Deviation|Mean
163321|NCT00252629|Secondary|Change of Pain Complaint|"Pain- increased level were rated 0-10 by visual analogue scale, where 0= no pain and 10= severe pain.~We compared the change of pain symptom before and after treatment of either 3 weeks on therapeutic nasal CPAP or sham nasal CPAP"|3 weeks of treatment on either therapeutic or sham nasal CPAP|||units on a scale||Standard Deviation|Mean
163322|NCT00252629|Primary|Change of Fatigue Symptom|Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.|3 weeks treatment with either therapeutic or sham CPAP|||units on a scale||Standard Error|Mean
163323|NCT00252590|Secondary|Percentage of Days Abstinent From All Substances|Percentage of days abstinent from both alcohol and drugs|4 months|||percentage of days abstinent||Standard Deviation|Mean
163324|NCT00252590|Primary|Percentage of Days Abstinent From Alcohol||4 months|||percentage of days abstinent alcohol||Standard Deviation|Mean
163325|NCT00252564|Secondary|Overall Response Rate|Percentage of patients with tumor response (by RECIST criteria, including complete response, or CR, i.e. disappearance of all target lesions; and partial response, or PR, i.e. at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of the longest diameters) among all “per-protocol population” patients.|(during the whole treatment period)|This analysis included all eligible and treated patients, i.e. per-protocol population. A patient will be considered in the arm he/she is actually treated, not randomized.||%||95% Confidence Interval|Number
163326|NCT00252564|Secondary|Overall Survival (OS)|"From randomization to death (event); or last follow-up date if alive (censoring).~Kaplan-Meier OS median time."|(no predetermined maximum time)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.||Month||95% Confidence Interval|Median
163327|NCT00252564|Primary|Progression-free Survival (PFS)|"From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).~Kaplan-Meier median PFS time and PFS rate at 12 months."|(no pre-determined maximum time. PFS rate at 12 months)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.||%||95% Confidence Interval|Number
163328|NCT00252564|Primary|Progression-Free Survival (PFS)|"From randomization to first progression or death, whichever comes first (event); or first new anti-cancer treatment if before or without progression / death (censoring); or last follow-up date otherwise (censoring).~Kaplan-Meier median PFS time and PFS rate (at 12 months)"|(no pre-determined maximum time)|This analysis included all registered (or randomized) patients, i.e. intent-to-treat (ITT) population, regardless of patient’s treatment status.||month||95% Confidence Interval|Median
163372|NCT00251862|Secondary|Screening Intentions|Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for “not at all sure” to 5 for “completely sure”.|Immediate post-intervention study visit|||units on a scale||Standard Deviation|Mean
163329|NCT00252538|Primary|Phenotype and Genotype Based on Presence of Interferon Induced MDD.|"Structured psychiatric interviews and symptom rating scales for depression were used as primary outcome measures to determine the association between phenotype (interferon-induced depression) and genotype (genes that confer risk of interferon-induced depression). Genes of interest related to development of depression and antiviral treatment response that may confer risk for interferon induced depression were examined. this was a multi-site study and included participants from several hospital settings.~Three polymorphisms of the interleukin (IL)-28b gene were examined - the c/c, c/t and t/t - and the relationship to MDD was examined. P-values above 0.05 are considered statistically insignificant in this study.~In a subsequent analysis of only VA participants proinflammatory cytokines and serotonin levels were examined relative to symptoms of depression."|The proposed enrollment began after funding notification and enrollment will last for a period of 40 months and until end of study.|This is an observational study that segregates patients with HCV and on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD. total sample from multiple sites.||participants|||Number
163330|NCT00252512|Secondary|Employment, Housing, Legal, and Psychiatric Status at Two, Six, and 12 Month Follow-up Interviews; Administrative Data on VA Service Utilization at Six and 12 Month Follow-ups.||8 weeks, 6 months, 12 months||||||
163331|NCT00252512|Primary|Number of Negative Breath Alcohol and Urine Drug Screens Out of Possible 16||8 weeks|||negative alcohol and drug screens||Standard Deviation|Mean
163332|NCT00252499|Secondary|Change in Hepatic Insulin Sensitivity From Baseline to 6 Months|Hepatic insulin sensitivity was determined as the percent suppression of endogenous glucose production (EGP) at the end of the low dose insulin clamp.|6 months|||percent of baseline EGP||Standard Error|Mean
163333|NCT00252499|Secondary|Changes in Intra-abdominal Fat Area From Baseline to 6 Months|Unenhanced CT scan images were obtained on a General Electric Discovery HD750 CT scanner. Intra-abdominal (IAF) areas were measured at the top of the iliac crest and quantified using the Tomovision program (SliceOMatic V4.3) by one trained technologist.|6 months|||mm2||Standard Error|Mean
163334|NCT00252499|Secondary|Change in Peripheral Insulin Sensitivity From Baseline to 6 Months|A two-step stable isotope labeled, hyperinsulinemic-euglycemic clamp procedure was performed with a low dose insulin infusion (20 mU/m2/min) for 3 hours followed by a primed high dose insulin infusion (160 mU/m2/min x 5 minutes then 80 mU/m2/min) for two hours. D20 was infused and adjusted to maintain the blood glucose at 90 mg/dl. Samples for glucose, insulin and 6,6 2d glucose were drawn every 15 minutes during the final half hour of the basal, low dose and high dose insulin periods. Whole body insulin sensitivity was calculated as the rate of glucose disposal (Rd)/lean body mass during the high dose insulin infusion.|6 months|One person in Arm 1 dropped out and thus is lacking 6 month data. The 6 month isotope data to calculate the rate of glucose disposal was not available for one subject in Arm 3.||mg/min/kg||Standard Error|Mean
163335|NCT00252499|Secondary|Change in the Liver Spleen Ratio by CT Scan From Baseline to 6 Months as a Measure of Fat in the Liver||6 months|||ratio||Standard Error|Mean
163336|NCT00252499|Secondary|Change in Alanine Aminotransferase (ALT) Levels From Baseline to 6 Months||6 months|||U/L||Standard Error|Mean
163337|NCT00252499|Primary|Liver/Spleen Ratio at 6 Months|Liver fat was estimated by non-contrast CT scan measuring the density ratio between the liver and spleen by Hounsfield units (liver/spleen ratio), which has been previously correlated with liver fat quantification by magnetic resonance spectroscopy.Ten separate measurements equally distributed throughout the liver and spleen were obtained and the Hounsfield units averaged. In subjects with more than one slice through the liver and spleen, the values for all slices were averaged.|6 months|||ratio||Standard Error|Mean
163338|NCT00252239|Primary|Functional Handicap (Modified Rankin Score)|The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported.|3 months|||percentage of participants|||Number
163339|NCT00252187|Secondary|Change in Left Ventricular Ejection Fraction at 8 Weeks|Left Ventricle Ejection Fraction (LVEF)is a clinical parameter used by cardiologists to describe how well the heart is pumping. LVEF is a measure of the amount of blood pumped out of the lower chamber (ventricle) of the heart during a heartbeat, measured by Magnetic Resonance Imaging (MRI).|Baseline and 8 weeks|Per protocol population||percentage||Standard Deviation|Mean
163340|NCT00252187|Secondary|Change in Blood Pressure at 8 Weeks|Blood pressure was measured during the MRI|Baseline and 8 weeks|Per protocol population||mmHg||Standard Deviation|Mean
163341|NCT00252187|Secondary|Change in Heart Rate at 8 Weeks|Heart rate was measured when MRI was performed|Baseline and 8 weeks|Per protocol population||beats per minute||Standard Deviation|Mean
163342|NCT00252187|Primary|Change in Left Ventricular (LV) Mass Index at 8 Weeks||Baseline and 8 weeks|Per protocol population||mg/m^2||Standard Deviation|Mean
163343|NCT00252187|Secondary|Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks|Kidney function was measured by GFR determined by iothalamate clearance. Glomerular filtration rate describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body-surface area. A lower GFR means the kidney is not filtering normally.|Baseline and 8 weeks|Per protocol population||ml/min/1.73 m^2 of body-surface area||Standard Deviation|Mean
163344|NCT00252187|Secondary|Change in Plasma Renin Activity at 8 Weeks|Plasma renin is synthesized within circulation or at tissue sites, causing vasoconstriction or vasodilation.|Baseline and 8 weeks|Per protocol population||nanograms per milliliter per hour||Standard Deviation|Mean
163345|NCT00252187|Secondary|Change in Left Ventricular (LV) Filling Pressure at 8 Weeks|Filling pressure determined by ratio of E/e' [Echocardiograph Doppler mitral inflow velocity (E) to mitral annulus tissue Doppler velocity (e') ratio]|Baseline and 8 weeks|Per protocol population||E/e'||Standard Deviation|Mean
163346|NCT00252187|Primary|Change in Left Ventricular (LV) Volume Index at 8 Weeks|LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.|Baseline and 8 weeks|Per protocol population||ml/m^2||Standard Deviation|Mean
163422|NCT00251316|Primary|The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.||1 year|||Participants|||Number
168725|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18|||L||Standard Error|Mean
163347|NCT00252057|Primary|Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge.|The total number of rehospitalizations (emergency department visits plus hospital admissions) in the 30 days after discharge, compared across study arms. Participants could have more than one rehospitalization in this period; all rehospitalizations for each were counted, making the unit of measure the rehospitalizations and not the participants.|30 days after discharge|||Total number of rehospitalizations|||Number
163348|NCT00251979|Secondary|Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period||Within 30 days|||days|||Number
163349|NCT00251979|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days|||blood units|||Number
163350|NCT00251979|Secondary|Number of Blood Units Transfused Within 72 Hours||Within 72 hours|||blood units|||Number
163351|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 30 Days||Within 30 days|||Participants|||Number
163352|NCT00251979|Secondary|Requirement for Endoscopic Re-treatment Within 72 Hours||Within 72 hours|||Participants|||Number
163353|NCT00251979|Secondary|Requirement for Surgery Within 30 Days||Within 30 days|||Participants|||Number
163354|NCT00251979|Secondary|Requirement for Surgery Within 72 Hours||Within 72 hours|||Participants|||Number
163355|NCT00251979|Secondary|Death Related to Rebleeding Within 30 Days as Judged by the EpC||Within 30 days|||Participants|||Number
163356|NCT00251979|Secondary|Death Within 30 Days||Within 30 days|||Participants|||Number
163357|NCT00251979|Secondary|Death Within 72 Hours||Within 72 hours|||Participants|||Number
163358|NCT00251979|Secondary|Clinically Significant Rebleeding Within 30 Days||Within 30 days|||Participants|||Number
163359|NCT00251979|Secondary|Clinically Significant Rebleeding Within 7 Days||Within 7 days|||Participants|||Number
163360|NCT00251979|Primary|Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo||Within 72 hours|||Participants|||Number
163361|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn|At 5 year visit|||participants|||Number
163362|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn|At 5 year visit|||participants|||Number
163363|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn|At 5 year visit|||participants|||Number
163364|NCT00251927|Secondary|Los Angeles (LA) Grade C at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
163365|NCT00251927|Secondary|Los Angeles (LA) Grade 'B' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
163366|NCT00251927|Secondary|Los Angeles (LA) Grade 'A' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
163367|NCT00251927|Secondary|Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit|Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included|At 5 year visit|||percentage of time recorded||Standard Deviation|Mean
163368|NCT00251927|Secondary|Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit|The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included|At 5 year visit|||units on a scale||Standard Error|Mean
163369|NCT00251927|Secondary|Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn|Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn|At 5 year visit|||participants|||Number
163370|NCT00251927|Secondary|Los Angeles (LA) Grade 'Normal' at 5 Year Visit|"Endoscopic findings classified according to the Los Angeles classification:~Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference"|At 5 year visit|||participants|||Number
163371|NCT00251927|Primary|Number of Participants With Treatment Failure at 5 Years|Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.|During 5 years|||participants|||Number
163423|NCT00251303|Primary|Children's Yale-Brown Obsessive-Compulsive Scale Scores (CY-BOCS)|CY-BOCS is a 0-40 point scale of obsessive-compulsive symptom severity, higher number indicates more severe obsessive-compulsive symptoms. Comparison of 12 weeks scores for placebo and riluzole groups.|12 weeks|||units on a scale||Standard Deviation|Mean
163373|NCT00251862|Secondary|Patient Satisfaction With Decision Making Process|Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for “strongly disagree” (or “poor”) to 5 for “strongly agree” (or “excellent”). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.|Immediate post-intervention primary care provider (PCP) visit|||units on a scale||Standard Deviation|Mean
163374|NCT00251862|Secondary|Patient Knowledge|Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don’t know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.|Immediate post-intervention study visit|||units on a scale||Standard Deviation|Mean
163375|NCT00251862|Primary|Patient Adherence (Test Completion)|Completion of a screening test within 12 months of the study visit.|12 months post-intervention|Intention to treat||participants|||Number
163376|NCT00251004|Secondary|Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula|"Modification of Diet in Renal Disease (MDRD) formula is:~GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R where~C is the serum concentration of creatinine [mg/dL],~A is patient age at sample collection date [years],~G=0.742 when gender is female, otherwise G=1,~R=1.21 when race is black, otherwise R=1"|at 12 months|Intention to treat (ITT) population.||mL/min/1.73m^2|||Number
163377|NCT00251004|Primary|Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.|12 months|Intention-to-treat population||Percentage of Participants|||Number
163378|NCT00251004|Secondary|Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation|"Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant.~A loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316."|12 months|Intention-to-treat (ITT) population.||Percentage of participants|||Number
163379|NCT00251004|Primary|Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis|The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.|12 months|Intention-to-treat (ITT) population||Participants|||Number
163380|NCT00250926|Primary|Time to Progression|Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).|42 months|The median time to progression was not achieved as follow-up ended before half the participants had a PD event.||months||Full Range|Median
163381|NCT00250926|Primary|Time to Best Response||33.2 months|||Months||Full Range|Median
163382|NCT00250926|Primary|Response Rate|"This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows.~A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed."|33.2 months|all enrolled patients||participants|||Number
163383|NCT00250926|Primary|Number of Participants With Adverse Events|This outcome measure was to assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia.|33.2 months|All enrolled patients||participants|||Number
163384|NCT00250835|Secondary|Pelvic Local Control Rate|Pelvic local control rate is defined as the proportion of subjects who have no evidence of pelvic recurrence (by standard clinical assessment, including CT scan and clinical examination) at the final follow-up evaluation, out of all evaluable patients|Up to 3 years after surgery|||percentage of evaluable participants|||Number
163385|NCT00250835|Secondary|Surgical Downstaging Rate|Downstaging rate after neoadjuvant treatment with combination oxaliplatin, capecitabine, celecoxib and concurrent radiation is defined as the proportion of patients whose pathological stage (stage at surgery) is different from their clinical stage (stage at baseline)|At surgery (up to 6 weeks after treatment)|||percentage of evaluable participants||95% Confidence Interval|Number
163386|NCT00250835|Secondary|Incidence of Sphincter-sparing Surgery|Incidence of sphincter-saving surgery is defined as the proportion of subjects who do not have permanent colostomy at the final follow-up out of all evaluable patients.|At surgery (up to 6 weeks after end of treatment)|||percentage of evaluable participants||95% Confidence Interval|Number
163424|NCT00251303|Primary|Much/Very Much Improved on Clinical Global Impressions - Improvement Score (CGI-I)||12 weeks|||participants|||Number
163425|NCT00250718|Secondary|Toxicity||End of 2 cycles (cycle = 28 days)|Trial was terminated early due to low accrual; no data to report. Adverse event data for enrolled patients is reported in the adverse event results section.|||||
163387|NCT00250835|Secondary|Progression-free Survival (PFS)|"The Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (Version 1.0) will be used to determine tumor response and progression. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions. Time to progression will be measured from the time of surgery or clinically documented down staging if surgery for whatever reason is not carried in the subject until there is evidence of PD.~Progression-free survival is reported as the percentage of patients who have not experienced progression of disease at three years post-surgery"|3 years after surgery|||percentage of evaluable participants||95% Confidence Interval|Number
163388|NCT00250835|Secondary|Toxicity|"All toxicities encountered during the study will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0.~Toxicity will be reported as the proportion of subjects experiencing Grades 3,4, and 5 adverse events (AEs) out of all evaluable patients"|Up to 3 years|||percentage of participants|||Number
163389|NCT00250835|Primary|Pathologic Complete Response (PCR)|The pathologic complete response (PCR) rate will be calculated as the proportion of patients who achieve complete response out of all evaluable patients. PCR is defined as the total absence of residual tumor cells by microscopic examination of the resected surgical specimen, including all of the sampled lymph nodes.|At surgery (up to 6 weeks after end of treatment)|Patients who continue on at least two of the three drugs for a minimum of 14 days are considered evaluable for the primary objective||percentage of evaluable participants||95% Confidence Interval|Number
163390|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Standard Deviation|Mean
163391|NCT00251758|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Inter-Quartile Range|Median
163392|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Standard Deviation|Mean
163393|NCT00251758|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Inter-Quartile Range|Median
163394|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Standard Deviation|Mean
163395|NCT00251745|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.|4 weeks|Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.||percentage of days||Inter-Quartile Range|Median
163396|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Standard Deviation|Mean
163397|NCT00251745|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median|The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.|4 weeks|Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.||percentage of days||Inter-Quartile Range|Median
163556|NCT00248638|Primary|Percent of Patients Who do Not Develop Hospital Infections After Entry|Subjects remaining infection-free during the hospitalization.|While the patient is admitted during the current hospitalization up to 6 months|||percentage of participants|||Number
163557|NCT00248638|Primary|Hospital Mortality|Mortality during the current hospitalization|Mortality during the current hospitalization up to 6 months|||participants|||Number
163398|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
163399|NCT00251719|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||percentage of subjects|||Number
163400|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
163401|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
163402|NCT00251719|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|Week 8|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||percentage of subjects|||Number
163403|NCT00251719|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analysis were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment that was performed within 7 days of the last day of study drug.||percentage of subjects|||Number
163404|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||Percentage of subjects|||Number
163405|NCT00251693|Secondary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|4 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||Percentage of subjects|||Number
163406|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||Percentage of subjects|||Number
163407|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.||percentage of subjects|||Number
163444|NCT00250679|Secondary|Transitional (Relative Change in) Dyspnea Index|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A Transitional Dyspnea Index score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
163408|NCT00251693|Secondary|Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn’t meet the A criterion, it’s counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||percentage of subjects|||Number
163409|NCT00251693|Primary|Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.|Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.|8 Weeks|Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.||Percentage of subjects|||Number
163410|NCT00251641|Secondary|Proportion of Participants Who Achieved a PGA Score of Cleared or Minimal at Week 26|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|26 weeks|ITT||Proportion of participants|||Number
163411|NCT00251641|Secondary|Proportion of Participants Who Achieved a Physician's Global Assessment (PGA) Score of Cleared or Minimal at Week 16|PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).|16 weeks|ITT||Proportion of participants|||Number
163412|NCT00251641|Secondary|PASI75 Response at Week 26|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|26 weeks|Intent-to-treat||Proportion of participants|||Number
163413|NCT00251641|Primary|Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16.|PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.|16 weeks|All subjects who were randomized were included in the efficacy analysis (intent-to-treat [ITT]).||Proportion of participants|||Number
163414|NCT00251589|Secondary|Progression-free Survival|Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded).|Day 1 to disease progression or death|"All patients as treated population with post-baseline data available to determine progression free survival.~Cohort A, Dose Level 1 (Amended), Cohort B, Dose Level 2 and Cohort A, Dose Level 1 (Original) are not represented in the below table as post-baseline data were not available to determine progression free survival."||Days||Full Range|Mean
163415|NCT00251589|Secondary|Disease Progression After Week 8 Based on Response Criteria in Solid Tumors (RECIST)|First documentation of Progressive Disease (PD) occurring > 8 weeks on study.|Every 57 days beginning with Cycle 3 (Week 8), or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Disease Progression After Week 8.||Participants|||Number
163416|NCT00251589|Secondary|Progressive Disease (PD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Progressive disease is defined as a ≥20% increase in the sum of the longest diameter, the appearance of one or more new lesions and/or unequivocal progression of non-target lesions by conventional or spiral CT or MRI|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Progressive Disease as Best Response.||Participants|||Number
163417|NCT00251589|Secondary|Stable Disease (SD) as Best Response Based on Response Criteria in Solid Tumors (RECIST)|Stable disease is defined as less than a radiographic partial response, but not progressive disease|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients treated population with post-baseline data available to determine Stable Disease as Best Response.||Participants|||Number
163418|NCT00251589|Post-Hoc|Dose Limiting Toxicity Occurring in Cycles 2 and Beyond of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycles 2 and beyond of the Phase II portion of the study.|After day 28 in the Phase II portion of the study|All patients as treated population in Cycles 2 and beyond of the Phase II portion of the study.||Participants|||Number
163419|NCT00251589|Primary|Dose Limiting Toxicity Occurring in Cycle 1 of the Phase II Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase II portion of the study.|Day 1 to 28 in the Phase II portion of the study|All patients as treated population in Cycle 1 of the Phase II portion of the study.||Participants|||Number
163420|NCT00251589|Secondary|Unconfirmed Partial Response (UPR) Based on Response Criteria in Solid Tumors (RECIST)|An unconfirmed partial response is defined as a partial response that has not been confirmed by a follow up CT scan (or MRI) at least 4 weeks after the criteria for response are first met. (A partial response is defined as an at least 30% reduction in the sum of the longest diameter of the target lesions. Non-target lesions must be at least stable)|Every 57 days beginning with Cycle 3, or more frequently if appropriate|All patients as treated population with post-baseline data available to determine Unconfirmed Partial Response as Best Response.||Participants|||Number
163421|NCT00251589|Primary|Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study|Adverse event(s) that determined the treatment dose level was not tolerable for that patient in Cycle 1 of the Phase I portion of the study.|Day 1 to 28 in the Phase I portion of the study|All patients as treated population in Cycle 1 of the Phase I portion of the study.||Participants|||Number
163426|NCT00250718|Primary|Overall Response Rate (ORR), the Sum of Complete and Partial Responses|"Solid tumor response is per Response Evaluation Criteria in Solid Tumors (RECIST) (ver 1.0).~For CLL: complete remission (CR) requires the following for>=2 months 1) no symptoms attributable to CLL, 2) normal physical examination, 3) absolute lymphocyte count<4,000/µL, 4) ANC>1,500/µL, 5) platelets>100,000/µL, 6) hemoglobin>11 g/dL, 7) bone marrow lymphocytosis<30%, 8) no nodules in bone marrow. Partial response (PR) requires the following for >=2 months 1) decrease in previously enlarged nodes, spleen, and liver by >=50%, 2) ANC>=1,500/µL or platelets>=100,000/µL, 3) hemoglobin>=11 g/dL, 4) 50% improvement over pre-therapy reductions in hemoglobin and/or platelets.~For MM, CR is no monoclonal protein (M-protein) in blood and urine and <5% plasma cells in bone marrow on >=2 determinations >=6 wk apart & stable bone disease & calcium levels. PR is>50% and >90% decreases in serum & urine M-protein, respectively, on >=2 occasions for >=6 wk, stable bone disease & calcium."|Up to 6 months after first on-study treatment|Trial was terminated due to low accrual; no data to report. An insufficient number of subjects were accrued to report data accurately.|||||
163427|NCT00250679|Secondary|Mean Values for Forced Expiratory Volume in One Second (FEV1)|Forced Expiratory Volume in one second|Baseline (Visit 2), weeks 3, 13, 26|||Liters||Standard Deviation|Mean
163428|NCT00250679|Secondary|Mean Values for Inspiratory Capacity|Inspiratory capacity is the maximum volume that can be inhaled.|Baseline (Visit 2), Weeks 3, 13, 26|||Liters||Standard Deviation|Mean
163429|NCT00250679|Secondary|Mean Values for Subject Global Evaluations|The subject global evaluation is reported by study subjects/participants. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), weeks 13, 26|ITT Population||units on a scale||Standard Deviation|Mean
163430|NCT00250679|Secondary|Mean Values for St. George's Respiratory Questionnaire|A questionnaire to assess respiratory health. Scores are expressed as a percentage of overall impairment (total score), where 100 represents the worst possible health status and 0 indicates best possible health status.|Baseline (Visit 2), weeks 13, 26|ITT population||units on a scale||Standard Deviation|Mean
163431|NCT00250679|Secondary|Mean Values for Investigator Global Evaluations|The investigator global evaluation is reported by the study investigator. It is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse.|Baseline (Visit 2), Weeks 13, 26|ITT population||units on a scale||Standard Deviation|Mean
163432|NCT00250679|Secondary|Mean Values for the 6-Minute Walk Test: Distance Walked in Meters|This test measures the participants' level of fitness. It is a measure of the distance the participant can walk in 6 minutes.|Baseline (Visit 2), week 13, week 26|ITT population||meters||Standard Deviation|Mean
163433|NCT00250679|Secondary|Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire|Percent of participants with a >=4 unit improvement in the overall impairment (total score) of the St. George's Respiratory Questionaire. This questionaire uses a 100 - 0 scale, where 100 represents the worst possible health status and 0 indicates the best possible health status.|visit 4 (week 13), visit 5 (week 26)|ITT population||percent of participants|||Number
163434|NCT00250679|Secondary|Percent (%) of Participants With an Improved Transitional Dyspnea Index|The percentage of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score is the sum of the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|visits 4 (week 13), visit 5 (week 26)|"ITT population. Percentages were based on the number of subjects with non-missing data.~Visit 4 n=115, 113, 114 Visit 5 n=108, 102, 103"||percent of participants|||Number
163435|NCT00250679|Secondary|Modified Medical Research Council Dyspnea Questionaire|Scores range from 0 to 4, with a score of 4 indicating that a subject is too breathless to leave the house or becomes breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.|Baseline (visit 2), weeks 13, 26|ITT Population||units on a scale||Standard Deviation|Mean
163436|NCT00250679|Secondary|Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire|Scores are expressed as the number of participants with >= 4 unit improvement in overall impairment (total score), where 100 represents worst possible health status and 0 indicates best possible health status.|Visit 4 (week 13) , Visit 5 (week 26)|ITT Population||Participants|||Number
163437|NCT00250679|Secondary|Mean Change From Baseline in St. George's Respiratory Questionnaire|Scores are expressed as a mean change from baseline of overall impairment (total score). The questionnaire has a scale of 100 which represents worst possible health status to 0 which indicates best possible health status.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
163438|NCT00250679|Secondary|6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes|Mean change from baseline in distance walked (meters)|Post-Dose weeks 0, 13, 26|ITT Population||meters||95% Confidence Interval|Mean
163439|NCT00250679|Secondary|BODE Index|The BODE index (0=relative health and 10=severe chronic obstructive pulmonary disease) is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the 6-minute walk test. Scores were derived using pre-dose assessments from each visit.|Baseline (visit 2), weeks 13, 26|ITT Population||units on a scale||Standard Deviation|Mean
163440|NCT00250679|Secondary|Investigator Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1 = much better and 7 = much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
163441|NCT00250679|Secondary|Subject Global Evaluations Change From Baseline|The global evaluation is a COPD symptoms rating ranging from 1 to 7, with 1=much better and 7=much worse. Ratings were assessed relative to the subject's initial entry into the study.|weeks 13, 26|ITT Population||units on a scale||95% Confidence Interval|Mean
163442|NCT00250679|Secondary|Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)|The 24 hour trough is the FEV1 value obtained 24 hours post first dose. This value is compared to the baseline FEV1 value.|weeks 0,3,13,26|ITT Population||Liters||95% Confidence Interval|Mean
163443|NCT00250679|Secondary|Number of Participants With an Improved Transitional Dyspnea Index|The number of participants with a transitional focal score (range -9 to 9) of >=1 improvement. Transitional focal score compares current health against baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores. A score of -9 is maximum worsening and 9 is maximum improvement.|weeks 13, 26|ITT Population. Visit 4 n=115,113,114 Visit 5 n=108,102,103||Participants|||Number
163445|NCT00250679|Secondary|Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline|Area under the change from baseline curve from 0 to 6 hours. Time-normalized AUC (0-6 hrs) was derived using the linear trapezoidal method.|weeks 0,3,13,26|ITT Population. Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.||Liter||95% Confidence Interval|Mean
163446|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Rescue medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Actuations/Day||95% Confidence Interval|Mean
163447|NCT00250679|Secondary|Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Rescue medication usage during the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Days Used / Week||95% Confidence Interval|Mean
163448|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day|Supplemental medication usage during the study. MDI stands for metered dose inhaler. An actuation is one depression of the device that releases medication.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Actuations / Day||95% Confidence Interval|Mean
163449|NCT00250679|Secondary|Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week|Supplemental medication usage is recorded throughout the study. MDI stands for metered dose inhaler.|Screening (day-14 to 0) and Treatment (week 0 - 26)|ITT Population||Days Used / Week||95% Confidence Interval|Mean
163450|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Heart Rate|Number of subjects with a heart rate that was lower/higher than a set limit and increased/decreased from set baseline limit in beats per minute (bpm)|visit 6 (week 27)|||Participants|||Number
163451|NCT00250679|Secondary|6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)|The 6 hour peak change from baseline is the maximum of the post-dose change values through 6 hours at each visit.|weeks 0,3,13,26|ITT population. An available cases analysis was performed with no imputation for missing data.||Liter||95% Confidence Interval|Mean
163452|NCT00250679|Secondary|Inspiratory Capacity Changes From Baseline|Mean Change in Inspiratory Capacity values from baseline (baseline assessment obtained at Visit 2, pre-dose). Spirometry measurements collected within 6 hours following in-clinic rescue/supplemental medications use were excluded from analysis.|weeks 0,3,13,26|ITT Population This outcome was added as an amendment after the study was initiated; therefore approximately half of the ITT population had these assessments at baseline. An available cases analysis was performed with no imputation for missing data.||Liter||95% Confidence Interval|Mean
163453|NCT00250679|Secondary|Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts|New Electrocardiogram (ECG) alerts are defined as those alerts that occurred post-treatment and were not present at baseline.|visit 6 (week 27)|ITT Population||Participants|||Number
163454|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Potassium Evaluations|Patients with potassium values that met low (<=3 mEq/L) or high (>=6 mEq/L) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population||Participants|||Number
163455|NCT00250679|Secondary|Number of Participants With Potentially Clinically Significant Glucose Evaluations|Patients with glucose values that met low (<=40 mg/dL) or high (>=175 mg/dL) criteria were considered potentially clinically significant.|visit 6 (week 27)|ITT Population||Participants|||Number
163456|NCT00250679|Secondary|Number of Participants With New 24-Hour Holter Monitoring Alerts|New holter monitoring alerts are defined as those alerts that occurred post-randomization and were not present at baseline.|Visit 6 (week 27)|ITT Population||Participants|||Number
163457|NCT00250679|Primary|Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations|"Percent of participants with the adverse event specified.~SOC = system organ class."|Six months|ITT Population||percent of participants|||Number
163458|NCT00250588|Secondary|Asthma Symptoms|Asthma symptom frequency was measured via the number of days and nights with asthma symptoms over the past two weeks. Night time asthma symptoms were converted to number of subjects experiencing night time asthma symptoms more than 1 time per week.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.||participants|||Number
163459|NCT00250588|Secondary|Counts of Patients With One or More Asthma-related Emergency Department Visits.|Utilization was measured by parent recall of emergency room visits for asthma over the last 6 months (at T1), 3 months (at T2), and 6 months (at T3).|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3.||participants|||Number
163460|NCT00250588|Primary|Parent Proxy-Reported Health-related Quality of Life (Pediatric Quality of Life Inventory)|The PedsQL™ 4.0 Generic Core Scales Total Scale Score (PedsQL™), which has been shown to be internally consistent, valid, and responsive to indicators of clinical change for children with asthma (Chan, Mangione-Smith, Burwinkle, Rosen, & Varni, 2005; Seid et al., in press; Varni et al., 2004). The 23-item PedsQL™ asks respondents how often various issues have been a ‘problem’ in the past month, yields a score of 0 to 100 (higher scores are better), and includes parallel child self-report (ages 5-18 years) and parent proxy-report (ages 2-18 years) forms. We measured both self- and proxy-report, although our a priori primary outcome was parent proxy-report.|Baseline (T1), Post Intervention (3mo, T2), 6-month follow up (9mo post baseline, T3)|All analyses were intent-to-treat and carried out according to a pre-established plan using SAS 9.1.3. All subjects with data at T2 or T3 were included in the analyses.||units on a scale||Standard Error|Mean
163461|NCT00250497|Secondary|Body Satisfaction|Ten questions assessing satisfaction with weight, height, and specific parts of the body; six Likert response categories.Body Satisfaction Scale Range=10-60 with higher values indicating increased body satisfaction.|One year|||units on a scale||Standard Deviation|Mean
163513|NCT00249249|Secondary|Triglycerides (TG)|mean triglycerides at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/dL||Standard Deviation|Mean
163514|NCT00249249|Secondary|TC:HDL-C Ratio|Ratio of mean total cholesterol to mean HDL-C at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||ratio||Standard Deviation|Mean
163462|NCT00250497|Secondary|Unhealthy Weight Control Behaviors|Ten questions assessing use of unhealthy weight control behaviors in the past month (yes/no). Behavior categories included fasted, ate very little, took diet pills, made myself vomit, used laxatives, used diuretics, used food substitutes, skipped meals, smoked more cigarettes, and went on a diet. If a respondent reported doing any of these behaviors, they were classified as having used unhealthy weight control behaviors.|One Year|||percentage of participants|||Number
163463|NCT00250497|Secondary|Sedentary Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of sedentary activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of sedentary activity per day|One Year|||average number of 30-minute blocks/day||Standard Deviation|Mean
163464|NCT00250497|Secondary|Fruits and Vegetables||One year|||Servings/day||Standard Deviation|Mean
163465|NCT00250497|Secondary|Level of Physical Activity|The 3DPAR assessed the sedentary behaviors and physical activities that study participants engaged in during each half hour time block between 6 AM and midnight on the three days previous to the day of data collection. In order to complete the 3DPAR, participants were provided with a list of 65 common sedentary behaviors and physical activities and were asked to select the activity that they participated in for the majority of every 30-minute block. The number of blocks of physical activity were summed for each day and then averaged over the 3 days. Outcomes was the average # of 30 minute blocks of physical activity.|One year|||average number of 30-minute blocks/day||Standard Deviation|Mean
163466|NCT00250497|Primary|Percent Body Fat|Measured with DEX-A at baseline and 1 year follow-up|One year|||% body fat (DXA)||Standard Deviation|Mean
163467|NCT00250484|Secondary|Medication Use (Medication Diary)|Data was not collected or recorded because this outcome measure was no longer considered useful or relevant in the study.|1 year||||||
163468|NCT00250484|Secondary|Cognitive Assessment - Neuropsychological Battery|"Beck Depression Inventory (BDI), and Visual Analog Scale (VAS) for anxiety were assessed in subjects both as a baseline score before treatment was initiated as and upon conclusion of treatment.~BDI is a 0-63 scale increasing with depression severity. A score from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 28-63 indicates severe depression. Higher values represent a worse outcome.~VAS is a pain assessment ranging from 0-10 increasing with pain severity. High values represent a worse outcome."|1 year|||units on a scale||Standard Deviation|Mean
163469|NCT00250484|Primary|Pain (Visual Analog Scale, CGI, PGA)|Pain intensity and therefore changes in pain intensity were assessed using a 0-10 Visual Analog Scale where 0 represents the least amount of pain and 10 is the most pain imaginable. The pain evaluation was carried out by a blinded rater based off 1) baseline evaluation: 3 week long pain logs and a diary of pain medication intake, 2) treatment evaluations: participants were also asked to fill out daily pain logs following each TMS session and to keep a diary of pain medications during the CRC stay for the TMS course and 3)follow-up evaluation: finally, there was a follow up measurement 3 weeks after treatment.|1 year|||number of participants w/ reduced pain|||Number
163470|NCT00250458|Secondary|Participants With Pain Relief at 2 Hours Postdose|Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.|2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
163471|NCT00250458|Primary|Participants With Elimination of Nausea at 2 Hours Postdose|Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.|At 2 hours after treatment|Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).||Participants|||Number
163472|NCT00250432|Secondary|Number of Patients With a Favorable Overall Response.|"Number of patients with a favorable overall response, defined as a clinical response of cure or apparent cure along with a microbiological response of eradication or presumptive eradication at the End of Caspofungin Therapy."|90 Days|Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol.||Participants|||Number
163473|NCT00250432|Primary|Number of Patients Who Develop Significant Drug-related Adverse Events.|Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.|90 Days|All patients as treated population||Participants|||Number
163474|NCT00249873|Secondary|Adjudicated Major Bleedings|The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug).|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
163475|NCT00249873|Secondary|Death From Any Cause (Cardiovascular and Noncardiovascular)|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
163476|NCT00249873|Secondary|Occurrence of Stroke|The event is the occurence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) after validation of the Event Adjudication Committee . The analysis is performed on the time from randomization to the occurrence of this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group.|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
163558|NCT00248625|Secondary|Infectious Complication||Within 7 days of randomization|||Participants|||Number
163477|NCT00249873|Primary|First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication|"The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :~stroke (nonfatal or fatal)~myocardial infarction (nonfatal or fatal)~non-CNS systemic embolism~vascular death~The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group."|expected median follow-up of approximately 3 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient’s compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.||participants|||Number
163478|NCT00249821|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse Events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the Investigational Medicinal Product (IMP).|Baseline (randomization) until Month 12|The safety population included all the participants who received at least 1 dose of study medication.||participants|||Number
163479|NCT00249821|Secondary|Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."||milligram/L (mg/L)||Standard Deviation|Mean
163480|NCT00249821|Secondary|Insulin Like Growth Factor-1 (IGF-1) Levels||Baseline (randomization), Month 6 and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."||microgram/liter (mcg/L)||Standard Deviation|Mean
163481|NCT00249821|Secondary|Change From Baseline in Bone Age at Month 12|Bone age was assessed by a left wrist X-Ray and evaluated by the investigator according to the Greulich and Pyle method.|Baseline (randomization) and Month 12|"FA set included all participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure and n = number of participants analyzed at that particular time point for each arm group respectively."||years||Standard Deviation|Mean
163482|NCT00249821|Secondary|Change From Baseline in Height at Month 6||Baseline (randomization) and Month 6|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.||cm||Standard Deviation|Mean
163483|NCT00249821|Secondary|Height Velocity-Standard Deviation Score (HV-SDS)|Height Velocity-Standard Deviation Score (HV-SDS) was calculated as height velocity minus reference mean height velocity divided by SD of the reference mean height velocity. Greater HV-SDS indicates greater height velocity.|Month 6 and Month 12|"FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Here n signifies number of participants analyzed at that particular time point for each arm group respectively. LOCF was used to impute missing values."||standard deviation score||Standard Deviation|Mean
163484|NCT00249821|Secondary|Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12|Height-Standard Deviation Score (H-SDS) was calculated as height minus mean (age-and sex-matched reference) divided by standard deviation (SD) [age and sex-matched reference]. Greater H-SDS indicates greater height.|Baseline (randomization), Month 6 and Month 12|FA set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. LOCF was used to impute missing values.||standard deviation score||Standard Deviation|Mean
163485|NCT00249821|Primary|Height Velocity|"Height Velocity (HV) is the change in height since the previous year´s measurement and more precisely:~HV = {(h-hp)/(d-dp)} * 365.25 [centimeter (cm)/year] where h is current height in cm, hp is previous height in cm, closest to 1 year previous, d is the current date and dp is the date of measurement of previous height, closest to 1 year previous. Additionally, d and dp have to be within 0.6 years and 1.5 years.~HV is the mean height velocity over the interval between d and dp but is displayed as HV at d."|Month 12|Full Analysis (FA) set included all the participants who received at least 1 dose of study medication and had at least 1 height evaluation post randomization. Last observation carried forward (LOCF) was used to impute missing values.||centimeter (cm)/year||Standard Deviation|Mean
163486|NCT00249795|Secondary|First Hospitalisation for Other Cardiovascular (CV) Cause|The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
163487|NCT00249795|Secondary|First Hospitalisation for Heart Failure (HF)|The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
163488|NCT00249795|Secondary|First Occurrence of Any Heart Failure (HF) Episode|The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
163489|NCT00249795|Secondary|Death From Any Cause|The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for the analysis.||participants|||Number
163490|NCT00249795|Secondary|First Occurrence of Stroke|The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
163491|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication|The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for this analysis.||participants|||Number
163492|NCT00249795|Primary|First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication|The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).|Median follow-up of 4.5 years|The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient's compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.||participants|||Number
163493|NCT00249613|Primary|Any Substance Use Past 30 Days|Substance use in past 30 days at 12 months post intake|12 Months|||Odds ratio||95% Confidence Interval|Number
163494|NCT00249613|Secondary|Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model|Predictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models|12 month post intake|||Beta coefficient||95% Confidence Interval|Number
163495|NCT00249613|Primary|Predictors of Criminal Activity at 12 Months Post Intake||12 Months|||Odds ratio||95% Confidence Interval|Number
163496|NCT00249613|Primary|Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment||baseline and 1-year follow-up|Intention to treat (ITT)||Percentage reporting criminal activity|||Number
163497|NCT00249496|Primary|Percentage of Monthly Urine Samples That Are Negative for Cocaine|The percentage of urine samples collected at monthly assessments that are negative for cocaine.|1 year|||percentage of negative urine samples||Full Range|Mean
163498|NCT00249470|Primary|Cocaine Abstinence|Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine|6 months|||percentage of cocaine negative||Full Range|Mean
163499|NCT00249379|Secondary|Recidivism Rates|Number of participants returning to jail during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
163500|NCT00249379|Secondary|Retention in Drug Court|Number of participants remaining in drug treatment court program during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
163501|NCT00249379|Primary|Level of Acceptance|Number of participants taking study medication during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
163502|NCT00249379|Primary|Drinking and Other Drug Use|Number of participants using alcohol and other drugs during 12 weeks|12 weeks|"Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study.~No data were collected for the Control Arm because funding ran out for the study."||participants|||Number
163503|NCT00249288|Primary|Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS|The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score).|Baseline score vs. week 12 score|||Units on a scale||Standard Deviation|Mean
163504|NCT00249288|Secondary|Correlations Between Red Blood Cell Folate Concentrations and Clinical Ratings of Negative Symptoms and by Comparing Folate Concentrations in Deficit Syndrome Versus Non-deficit Syndrome Patients||12 weeks||||||
163505|NCT00249288|Primary|Correlation Between Baseline Blood Folate, Homocysteine or B12 Levels and Dietary Intake or Cigarette Smoking||12 weeks||||||
163506|NCT00249249|Secondary|National Cholesterol Education Program [NCEP]LDL-C Target Attainment|Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)|up to 12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||Patients|||Number
163507|NCT00249249|Secondary|Oxidized LDL at 12 Weeks|oxidized low density lipoprotein at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||U/L||Standard Deviation|Mean
163508|NCT00249249|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks|high sensitivity C-reactive protein (hs-CRP) at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/L||Standard Deviation|Mean
163509|NCT00249249|Secondary|Apo-B:Apo-A1 Ratio|Ratio of Apo-B to Apo-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||ratio||Standard Deviation|Mean
163510|NCT00249249|Secondary|Apolipoprotein-A1 (Apo-A1)|Apolipoprotein-A1 at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/dL||Standard Deviation|Mean
163511|NCT00249249|Secondary|Apolipoprotein B (Apo B)|Apolipoprotein B at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||mg/dL||Standard Deviation|Mean
163512|NCT00249249|Secondary|Non-HDL:HDL Ratio|Ratio of non-HDL to HDL at 12 weeks|12 weeks|All patients, irrespective of protocol violations, who had Week 12 measurements, whether on drug or not.||||Standard Deviation|Mean
163518|NCT00247962|Secondary|Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline|ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a “Yes” (scored as 1) or “No” (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).|Baseline and 16 Weeks|The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.||units on a scale||Standard Deviation|Mean
163519|NCT00247962|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|16 weeks|All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations.||participants|||Number
163520|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 months|Treated population of participants with a non-index lesion.||percentage of stenosis|||Number
163521|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Month 9|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|9 months|Treated population of participants with a non-index lesion.||percentage of stenosis||Standard Deviation|Mean
163522|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 24|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|24 weeks|Treated population of participants with a non-index lesion.||percentage of stenosis||Standard Deviation|Mean
163523|NCT00249002|Primary|Stenosis (%) of a Non-index Lesion Using Angiography at Week 12|Non-indexed lesion with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the non-index lesion is measured by angiography. Three non-index lesions are reported: central vein, intragraft and arterial anastomosis.|12 weeks|Treated population of participants with a non-index lesion.||percentage of stenosis||Standard Deviation|Mean
163524|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 months|Treated population of participants with an index lesion at this site.||percentage of stenosis|||Number
163525|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Month 9|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|9 months|Treated population of participants with an index lesion at this site.||percentage of stenosis||Standard Deviation|Mean
163526|NCT00249002|Secondary|Percentage of Participants With Patency of Index and Non-Index Lesions at 24 Weeks|The patency (unblocking) for index lesions is defined as <50% of stenosis and no PFTE graft thrombosis at 24 weeks. The patency for non-index lesions is defined as <50% of stenosis and no new non-index lesions at 24 weeks.|24 weeks|Treated Population of evaluable participants||percentage of participants|||Number
163527|NCT00249002|Secondary|Kaplan Meier Estimates for Time to Graft Failure or Intervention|The time to graft failure or intervention was defined as the time from first dose of study drug to the first time graft failure or intervention. Participants who did not have graft failure or intervention at the end of the study were censored at the last known time that the participant had angiography.|up to 12 months|Treated population||weeks||95% Confidence Interval|Median
163528|NCT00249002|Secondary|Participants With Arthrosclerotic Cardiovascular Complications|Counts of participants who had treatment-emergent arthrosclerotic cardiovascular complications, specifically myocardial infarction, arterial thromboses, or cerebrovascular events.|up to week 25|Treated population||participants|||Number
163529|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 24|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|24 weeks|Treated population of participants with an index lesion at this site.||percentage of stenosis||Standard Deviation|Mean
163530|NCT00249002|Primary|Stenosis (%) of the Index Lesion at Venous Anastomosis Using Angiography at Week 12|Indexed lesion must be located in the arm and is a polytetrafluoroethylene (PTFE) thrombosed graft or a patent but dysfunctional PTFE graft with a residual stenosis of less than 30% after the pre-dose angioplasty. The percent of stenosis (narrowing) of the index lesion is measured by angiography.|12 weeks|Treated population of participants with an index lesion at this site.||percentage of stenosis||Standard Deviation|Mean
163531|NCT00249002|Primary|Percentage of Participants Without Graft Failure or Need for Intervention|Graft failure is defined as graft thrombosis, loss of vascular access function, or >50% stenosis of the index lesion at the time of a regularly scheduled angiographic assessment.|24 weeks|Evaluable participants who were treated||percentage of participants|||Number
163532|NCT00249002|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 21|Treated population||percentage of participants|||Number
163533|NCT00248807|Secondary|Cerebral Blood Flow|Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt|acute testing|||cm/sec||Standard Deviation|Mean
163535|NCT00248794|Primary|Independent Living Skills Survey|"Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as washes hair twice a week, and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning."|16 weeks after intake|||units on a scale||Standard Error|Mean
163536|NCT00248794|Primary|Hopkins Verbal Learning Test- Total Recall Variable|This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning.|16 weeks post intake assessment|||units on a scale (T-scores)||Standard Deviation|Mean
163537|NCT00248794|Primary|Continuous Performance Task X/A Version|CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance.|16 weeks after intake assessment|||units on a scale (standardized units)||Standard Deviation|Mean
163538|NCT00248794|Primary|Bell Lysaker Emotion Recognition Test|21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance.|16 weeks from intake|Two way ANOVA using baseline and completion of intervention data||total correct||Standard Deviation|Mean
163539|NCT00248794|Primary|Wisconsin Card Sort Percent Perseverative Errors (Standard Score)|"This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects density of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance."|16 weeks after intake|||standard score units||Standard Deviation|Mean
163540|NCT00248781|Secondary|Six-minute Walk (Durability)|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|12 months|||m||Standard Deviation|Mean
163541|NCT00248781|Secondary|Tandem Stance (Durability)|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|12 months|||s||Standard Deviation|Mean
163542|NCT00248781|Secondary|Single Leg Stance With Eyes Open (Durability)|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|12 months|||s||Standard Deviation|Mean
163543|NCT00248781|Secondary|Knee Flexion Strength (Durability)|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|12 months|||kg||Standard Deviation|Mean
163544|NCT00248781|Primary|Six-minute Walk|Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.|6 months|The number of subjects completing 6 month evaluations||m||Standard Deviation|Mean
163545|NCT00248781|Primary|Tandem Stance|Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.|6 months|The number of subjects completing 6 month evaluations||s||Standard Deviation|Mean
163546|NCT00248781|Primary|Single Leg Stance With Eyes Open|Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.|6 months|The number of subjects completing 6 month evaluations||s||Standard Deviation|Mean
163547|NCT00248781|Primary|Knee Flexion Strength|The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system|6 months|Number of subjects completing 6 month evaluations||kg||Standard Deviation|Mean
163548|NCT00248781|Secondary|Knee Extension Strength (Durability)|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|12 months|||kg||Standard Deviation|Mean
163549|NCT00248781|Primary|Knee Extension Strength|The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system|6 months|number of subjects completing 6 month evaluations||kg||Standard Deviation|Mean
163550|NCT00248651|Secondary|Dyspepsia-Specific Quality of Life|The Nepean Dyspepsia Index (NDI) assessed quality of life. NDI scores are summarized into overall quality of life and 5 subscales: Interference, Knowledge/Control, Eating/Drinking, Sleep Disturbance, Work/Study. The scale consists of 25 items, yielding 5 sub-scales. Range 0-100, higher numbers indicate a greater quality of life.|12 Weeks|The intent-to-treat analysis included all randomized subjects.||units on a scale||95% Confidence Interval|Mean
163551|NCT00248651|Secondary|Maximum Tolerated Volume by Nutrient Drink Test|The nutrient drink test for meal-induced satiety had subjects drink 120 ml of ENSURE every four minutes. Satiety scores were measured on a scale graded 0-5 (1, no symptoms; 5, maximum satiety). When a score of 5 was reached, the maximum tolerated volume intake was measured. Abnormal satiety was defined as inability to consume > 800 ml of Ensure.|12 weeks|The intent-to-treat analysis included all randomized subjects.||ml||Standard Deviation|Mean
163552|NCT00248651|Secondary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|12 weeks|The intent-to-treat analysis included all randomized subjects.||minutes||Standard Deviation|Mean
163638|NCT00247273|Secondary|Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population|ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.|Baseline to Month 6|ITT||ng / mL||95% Confidence Interval|Least Squares Mean
163559|NCT00248625|Secondary|Highest Coma Grade of Hepatic Encephalopathy|West Haven Criteria for hepatic encephalopathy (Grade 0 - IV ) is used for participants > 3 year of age. Coma grade IV indicates a participant who is comatose , with no reflexes, is decerebrate and has abnormal EEG changes with very slow delta activity. For participants less than 3 years the Whittington Scale was used. The Whittington scale does not use EEG changes and has only 3 levels, early (grades I and II), Mid (III) with somnolence, stupor, combativeness and Late (IV) for participants who are comatose with absent reflexes and decerebrate or decorticate posturing.|Within 7 days of randomization|All enrolled participants where coma grade could be assessed. Four participants (two in each randomization arm) could not have coma grade assessed during the 7 days after randomization.||participants|||Number
163560|NCT00248625|Secondary|Number of Organ Systems Failing||Within 7 days of randomization|||participants|||Number
163561|NCT00248625|Secondary|Categorized Length of ICU Stay|The length of ICU stay was categorized as number of days in ICU within 7 days of randomization, unless participant either died or received an LTx within this time period. Special categories were created for these cases.|Within 7 days of randomization|||participants|||Number
163562|NCT00248625|Secondary|Length of Hospital Stay||Randomization to hospital discharge|All participants enrolled in study with hospital stay information, 2 participants (1 in each arm) did not have hospital discharge information.||days||Inter-Quartile Range|Median
163563|NCT00248625|Secondary|Cumulative Percent Incidence of Transplantation by 1 Year||Within 1 year of randomization|||percentage of participants|||Number
163564|NCT00248625|Secondary|Spontaneous Recovery|Survival without liver transplantation|One year following randomization|All participants enrolled in study||participants|||Number
163565|NCT00248625|Primary|Survival|Spontaneous survival without transplant plus survival following transplantation|One year following randomization|All participants who were enrolled in the study were included in the survival analysis||Participants|||Number
163566|NCT00248560|Secondary|Toxicity as Measured by Number and Grade of Adverse Events||Every 2 weeks||||||
163567|NCT00248560|Secondary|Survival||Every 8 weeks||||||
163568|NCT00248560|Secondary|Response Duration||Every 8 weeks||||||
163569|NCT00248560|Primary|Response (Complete Response [CR] + Partial Response [PR])|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks until off study|||participants|||Number
163570|NCT00248547|Secondary|Pharmacokinetic Interaction|To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.|Up to three weeks||||||
163571|NCT00248547|Secondary|Effects on Nausea, Appetite and Taste Changes|To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.|Up to three weeks||||||
163572|NCT00248547|Secondary|Safety in Transplant Population|To assess the safety of aprepitant in the bone marrow transplant population|Up to three weeks||||||
163573|NCT00248547|Primary|Number of Emesis Free Participants During the Study Period.|To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period|Up to three weeks|||Participants|||Number
163574|NCT00248287|Secondary|Median Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population||months||95% Confidence Interval|Median
163575|NCT00248287|Secondary|Median Time of Progression-free Survival (PFS)|PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.|2 years|ITT population||months||95% Confidence Interval|Median
163576|NCT00248287|Secondary|Duration of Response|"The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.||months||Full Range|Median
163577|NCT00248287|Primary|Objective Response Rates (ORR)|To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|Evaluable population||Percentage of Participants||95% Confidence Interval|Number
163578|NCT00248170|Secondary|Percentage of Participants Who Experienced Cardiovascular Events|The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.||Percentage of participants|||Number
163579|NCT00248170|Secondary|Percentage of Participants Who Experienced Clinical Fracture Events|The incidence of clinical fractures was analyzed.|84 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.||Percentage of participants|||Number
163580|NCT00248170|Secondary|Change From Baseline in Serum Lipid Profiles|Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.|baseline, 6, 12, 24, 36, 48 and 60 months|Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.||mg/dL||95% Confidence Interval|Mean
163595|NCT00247676|Secondary|Dose-Corrected Ctrough of Sunitinib|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
163581|NCT00248170|Secondary|Distant Disease-free Survival|Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
163582|NCT00248170|Secondary|Time to Development of Contra Lateral Breast Cancer|Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
163583|NCT00248170|Secondary|Time to Development of Distant Metastases|Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
163584|NCT00248170|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
163585|NCT00248170|Primary|Disease Free Survival|Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.|84 months|Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.||Months||95% Confidence Interval|Median
163586|NCT00247676|Secondary|Plasma Concentration of Soluble KIT (sKIT)|Plasma concentrations of sKIT that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
163587|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
163588|NCT00247676|Secondary|Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline). Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
163589|NCT00247676|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by ELISA. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||pg/mL||Full Range|Median
163590|NCT00247676|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor (VEGF)|Plasma concentrations of VEGF that may be associated with tumor proliferation or angiogenesis were collected from a subset of subjects and analyzed by e nzyme-linked immunosorbent assay (ELISA). Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio to Baseline = plasma concentration of soluble protein at timepoint / concentration of soluble protein at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28)|ITT||picograms (pg)/mL||Full Range|Median
163591|NCT00247676|Secondary|Tissue Tumor Markers Assessed by Tumor Biopsy|Provision of previously collected tumor paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block) for correlative laboratory analysis was optional. For all subjects showing OR on study, it was highly recommended to provide previously collected paraffin blocks (or at least 5-10 4-micron slides prepared from the paraffin block). These samples were to be analyzed for markers that may be associated with tumor proliferation or angiogenesis.|Day 28 of Cycle 1 (optional)|ITT. Tumor biopsy results were collected optionally in 5 subjects; however, no evaluations were performed.||intensity score||Standard Deviation|Mean
163592|NCT00247676|Secondary|Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs)|Blood samples for the assessment of CECs and circulating CEPs were planned to be obtained for subjects in Part 1 of the study, and for a subset of subjects in Part 2 of the study to complete the angiogenic profile of unresectable hepatocellular carcinoma, in addition to the soluble protein evaluation.|Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1)|ITT. Blood samples for CECs and CEP cells were collected during the study, but evaluations of these samples were not performed.||cells/mL||Standard Deviation|Mean
163593|NCT00247676|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
163594|NCT00247676|Secondary|Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib)|Data was dose-corrected to the starting dose (dose-corrected Ctrough = observed Ctrough x [starting dose/actual dose]).|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|PK||ng/mL||Standard Deviation|Mean
165203|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 6 months|||percentage of participants|||Number
163598|NCT00247676|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration.|Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28)|Pharmacokinetic (PK) = All subjects enrolled in the study who at least 1 PK sample collected.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
163599|NCT00247676|Secondary|1-Year Survival Probability|Probability of survival 1 year after the first dose of study treatment.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year.|ITT||Probability|||Number
163600|NCT00247676|Secondary|Overall Survival (ITT Child Pugh Class A Subject Population)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT Child Pugh Class A (assessment of liver function) subject population||Weeks||95% Confidence Interval|Median
163601|NCT00247676|Secondary|Overall Survival (Overall ITT)|Time from the date of first dose of study medication to the date of death due to any cause.|From start of study treatment until death.|ITT||Weeks||95% Confidence Interval|Median
163602|NCT00247676|Secondary|Time to Tumor Progression (ITT Child Pugh Class A Subject Population)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT Child Pugh Class A (assessment of liver function) subject population||Weeks||95% Confidence Interval|Median
163603|NCT00247676|Primary|Objective Response (CR or PR)|Number of patients with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in patients with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT||participants|||Number
163604|NCT00247676|Secondary|Time to Tumor Progression (Overall ITT)|Time from the start of study treatment to the first documentation of objective tumor progression.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT||Weeks||95% Confidence Interval|Median
163605|NCT00247676|Secondary|Progression-Free Survival (ITT Child Pugh Class A Subject Population)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT Child Pugh Class A (assessment of liver function) subject population = subjects enrolled in the study with Child-Pugh Class A that received at least 1 dose of study medication.||Weeks||95% Confidence Interval|Median
163606|NCT00247676|Secondary|Progression-Free Survival (Overall ITT)|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT||Weeks||95% Confidence Interval|Median
163607|NCT00247676|Secondary|Best Overall Response of PR or SD With Duration ≥12 Weeks|Number of patients with best overall response of PR or SD with duration ≥ 12 weeks. Best overall response was defined as the time from the first documentation of tumor response that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks or death due to cancer|ITT||participants|||Number
163608|NCT00247676|Secondary|Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks)|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR, or SD for at least 12 weeks on study according to RECIST. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. SD=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks on study|ITT||participants|||Number
163609|NCT00247676|Primary|Best Overall Response|Number of subjects with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ≥ 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of ≥ 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.||participants|||Number
163610|NCT00247676|Secondary|Duration of Objective Response (CR or PR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression or to death due to any cause. CR=disappearance of all target lesions. PR= ≥30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.|From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer|From the Overall ITT population, only 1 subject had Objective Response for evaluation of duration of objective response.||Weeks|||Number
163611|NCT00247611|Post-Hoc|Percentage of Participants Unemployed and on Disability||Data collected at Baseline|||percentage of participant|||Number
163612|NCT00247611|Primary|Visual Analog Scale Measure of Adherence to ART|"This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one’s regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated.~See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77"|Measured at each clinical visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparisons replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.||percent with 100% adherence|||Number
163614|NCT00247611|Primary|AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken|"This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained.~See: Chesney MA, Ickovics JR, Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient care committee & adherence working group of the outcomes committee of the adult AIDS clinical trials group (AACTG). AIDS Care. 2000;12(3):255-266."|Measured at each clinical care visit over 18 months of participation|Intent to treat included all participants with >=2 adherence assessments; OP sample further restricted this sample to those with >=6 assessments and no treatment interruptions over 18-months of participation. Multiple pairwise comparison replaced missing values. HLM was used for over-time analyses on proportion reporting perfect adherence.||percent with 100% adherence|||Number
163615|NCT00247416|Secondary|Progression-free Survival|progression-free survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, and every 3 months, an average of 471 days|||days||95% Confidence Interval|Median
163616|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Overall Survival.|Overall survival|Pre-treatment, pre-cycles 3 & 5,4 weeks after last treatment, every 3 months, an average of 471 days|||days||95% Confidence Interval|Median
163617|NCT00247416|Primary|Percentage of Participants With Reduction in Grade 3/4 Neutropenia|Reduction grade 3/4 neutropenia|continuous throughout treatment, up to 25 weeks|||percentage of participants|||Number
163618|NCT00247416|Secondary|Effect of Dexamethasone Pre-treatment on Response Rate.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Pre-treatment, pre-cycles 3 & 5, and up to 4 weeks after last treatment|||percentage of responders out of total||95% Confidence Interval|Number
163619|NCT00247377|Secondary|Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation|change in quality of life survey response for mental health using the SF-36 questionnaire where 0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163620|NCT00247377|Secondary|Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for the emotional role using the SF-36 questionnaire where 0 corresponds to no emotional role and 100 corresponds to full emotional role|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163621|NCT00247377|Secondary|Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for social functioning as measured using the SF-36 questionnaire where 0 corresponds to no social functioning and 100 corresponds to full social functioning|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163622|NCT00247377|Secondary|Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for vitality as measured using the SF-36 questionnaire with worst score being 0 and best score being 100 on a 1-100 point scale.|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163623|NCT00247377|Secondary|Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for general health using the SF-36 questionnaire where 0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163624|NCT00247377|Secondary|Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for bodily pain using the SF-36 questionnaire where 0 corresponds to no bodily pain and 100 corresponds to complete bodily pain|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163625|NCT00247377|Secondary|Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response for physical aspects of life using the SF-36 questionnaire where 0 corresponds to no Role-Physical and 100 corresponds to full Role-Physical|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163626|NCT00247377|Secondary|Cost of Procedure to the Medical Facility on Date of Procedure|operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point: date of surgery.|date of surgery|||dollars per patient||Standard Deviation|Mean
163627|NCT00247377|Primary|Excess Weight Loss From Pre-operation to 5 Years Post-operation|weight loss as measured by change in percent of excess body weight|Baseline to 5 years|Availability of subjects and protocol design||percent change||Standard Deviation|Mean
163628|NCT00247377|Secondary|Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation|change in quality of life survey response where 0 is non-functioning and 100 is fully functioning|Baseline to 12 months|||units on a scale||Standard Deviation|Mean
163629|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 24, ITT Population|At least 1 new fractured vertebra|Baseline to Month 24|ITT||Participants|||Number
163630|NCT00247273|Secondary|Number of Participants With New Vertebral Fracture at Month 12, ITT Population|At least 1 new fractured vertebra|Baseline to Month 12|ITT||Participants|||Number
163631|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
163632|NCT00247273|Secondary|Change From Baseline in Serum BAP at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 24|ITT||ug / L||95% Confidence Interval|Least Squares Mean
163633|NCT00247273|Secondary|Percent Change From Baseline in Serum BAP at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay)|Baseline to Month 6|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
163639|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
163640|NCT00247273|Secondary|Change From Baseline in Urine NTX/Cr at Month 24, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 24|ITT||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
163641|NCT00247273|Secondary|Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24.|Baseline to Month 6|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
163642|NCT00247273|Secondary|Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population|Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine|Baseline to Month 6|ITT||nmol BCE / mmol Creatinine||95% Confidence Interval|Least Squares Mean
163643|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT||g/cm^2||95% Confidence Interval|Least Squares Mean
163644|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 24|ITT||Percent Change||95% Confidence Interval|Least Squares Mean
163645|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).|Baseline to Month 24 - Endpoint|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
163646|NCT00247273|Secondary|Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT||g/cm^2||95% Confidence Interval|Least Squares Mean
163647|NCT00247273|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.|Baseline to Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
163648|NCT00247273|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population|BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).|Baseline to Month 12 - Endpoint|ITT (intent to treat) Population||Percent Change||95% Confidence Interval|Least Squares Mean
163649|NCT00246805|Primary|Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)|Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.|June 2009|||participants|||Number
163650|NCT00246805|Secondary|Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization||January 2009||||||
163651|NCT00246805|Secondary|Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate||January 2009||||||
163652|NCT00246805|Secondary|Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation||January 2009||||||
163653|NCT00246805|Secondary|Evaluation of Rate Irregularity Indicators and Patient's Symptoms||January 2009||||||
163654|NCT00246571|Secondary|Circulating Tumor Cells (CTC)|Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.||cells/7.5 mL||Standard Deviation|Mean
163655|NCT00246571|Secondary|Circulating Endothelial Cells (CEC)|Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.|Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal|ITT population. n = participants with available data at that time point.||cells/mL||Standard Deviation|Mean
163656|NCT00246571|Secondary|Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor|Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
163657|NCT00246571|Secondary|Plasma Concentration of Soluble Placental Growth Factor (sPlGF)|Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
163658|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)|Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
163659|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)|Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. n = participants with available data at that time point.||pg/mL||Standard Deviation|Mean
163660|NCT00246571|Secondary|Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)|Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker|Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal|ITT population. This outcome measure was not analyzed.||pg/mL||Standard Deviation|Mean
163661|NCT00246571|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)|Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
163662|NCT00246571|Secondary|Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)|Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
163663|NCT00246571|Secondary|Dose-corrected Ctrough of Sunitinib|Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.|Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
163664|NCT00246571|Secondary|Ctrough of Total Drug (Sunitinib + SU012662)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
163665|NCT00246571|Secondary|Ctrough of SU012662 (Metabolite of Sunitinib)||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
163666|NCT00246571|Secondary|Observed Plasma Trough Concentrations (Ctrough) of Sunitinib||Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3|ITT population. n = number of participants with available data for those time points.||ng/mL||Standard Deviation|Mean
163667|NCT00246571|Secondary|HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score|BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.||score on a scale|||Number
163668|NCT00246571|Secondary|Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.|Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal|This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.||score on a scale|||Number
163669|NCT00246571|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to 3 years after first dose of study medication)|ITT population||months||95% Confidence Interval|Median
163670|NCT00246571|Secondary|Survival Probability at 1 Year|Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.|Baseline until death (up to 3 years after first dose of study medication)|ITT population||ratio||95% Confidence Interval|Number
163671|NCT00246571|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Time from first response to disease progression up to 3 years from first dose|ITT population||months||95% Confidence Interval|Median
163672|NCT00246571|Secondary|Proportion of Participants With Objective Response|Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.|Baseline until response or disease progression (up to 3 years from first dose)|ITT population||percentage of participants||95% Confidence Interval|Number
163673|NCT00246571|Primary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)|Intent-to-Treat (ITT) population: all participants who were randomized.||Months||95% Confidence Interval|Median
163674|NCT00246519|Secondary|Adverse Metabolic Responses||9-18 weeks of treatment||||||
163675|NCT00246519|Primary|Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)).||baseline to 18 weeks of treatment|A total 768 patients had at least monotherapy response data. Of the 386 patients assigned to the atenolol arm, 357 completed both drugs. Of the 382 assigned to the HCTZ arm, 355 completed both drugs. The delta blood pressure below is for patients who completed both drugs.||mmHg||Standard Deviation|Mean
163683|NCT00246337|Secondary|Sustained Pain Freedom|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."||Participants|||Number
163684|NCT00246337|Secondary|Sustained Pain Relief|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.|2-24 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing"||Participants|||Number
163685|NCT00246337|Secondary|Pain Freedom at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."||Participants|||Number
163686|NCT00246337|Primary|Pain Relief at 2 Hours|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.|2 hours post dose|"All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized.~One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing."||Participants|||Number
163687|NCT00246324|Secondary|Determine Pre- and On-treatment Cytokine ELISA, MMP ELISA and Bioassay||8 months||||||
163688|NCT00246324|Secondary|Determine Safety and Tolerability of Combination Therapy With Avonex Plus Doxycycline||8 months||||||
163689|NCT00246324|Secondary|Relapse Rates, Serum Matrix Metalloproteinase 9 Levels, Transendothelial Migration of Monocytes|Only 1 patient relapsed. Correlations between decrease serum metalloproteinase 9 levels and enhancing lesion activity reduction. Transendothelial migration of monocytes was suppressed. Adverse effects were mild. No adverse synergistic effects of combination therapy.|8 months|||participants|||Number
163690|NCT00246324|Primary|Gadolinium-enhancing (Gd+)Lesion Number Change.|Before treatment is the number of lesions per image from months -3, -2, -1, and 0. During treatment is the number of lesions from months 1,2, and 3. The mean number of Gd+ lesions during each treatment period was calculated for each patient as the total number of Gd+ lesions observed across all images divided by the number of images. Hence, the mean number of Gd+ lesions per patient represents the number of lesions per MRI.|8 months|||Gd+ lesions||95% Confidence Interval|Median
163691|NCT00246259|Other Pre-specified|Abnormal Involuntary Movement Scale (AIMS)|The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none, 4=severe). Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dental status. Total scores range from 0 to 42 with higher values indicating more severity.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Units on a scale||Standard Deviation|Mean
163692|NCT00246259|Other Pre-specified|Simpson Angus Scale (SAS)|The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The 10 items are rated on a 5-point scale (0=complete absence, 4=extreme presence) after a brief neurological examination and observation of the participants’ gait (slow, shuffling walk). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Units on a scale||Standard Deviation|Mean
163693|NCT00246259|Other Pre-specified|Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment|The BARS evaluates akathisia (feeling of restlessness) associated with the use of antipsychotic medications, including an objective and a subjective component plus a global impression. Components are rated on a scale of 0 (normal or absence of restlessness)-3 (intense restlessness) and 0 (absent)-5 (severe akathisia) for the global clinical assessment. Number of participants in each global clinical assessment scale are reported.|Baseline, Week 104 or LRV|Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Participants|||Number
163702|NCT00246259|Secondary|Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV|Co-morbid depressive symptoms are evaluated by change in CDSS Score which was developed to assess symptoms of depression in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). It consists of 9 items, each scored from 0 (absent) to 3 (severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
163694|NCT00246259|Secondary|Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV|The SF-36 is a survey of participant health. It calculates two standardized scales: the standardized mental component scale and the standardized physical component scale. The standardized scales are calculated as weighted sums of the 8 scores, which are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range; and standardized mental component scale score is calculated as weighted average of individual item scores on a 0-100 range, where 100 signify highest level of functioning. The change from baseline in mental component scale score was reported.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
163695|NCT00246259|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV|The DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Units on a scale||Standard Deviation|Mean
163696|NCT00246259|Secondary|Total Words Score Over Time|Controlled Word Association Test (COWAT) was used to assess verbal fluency. Participants are given 3 different letters of the alphabet and asked to say as many words beginning with each letter within a controlled time. Participants are then asked to identify as many words as possible in 3 different categories (animals, fruits and vegetables) within a specified period of time. The total score is a sum of all three categories scores. The total score ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline, Week 104 or LRV|The ITT population:all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' signifies participants evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.||Units on a scale||Standard Deviation|Mean
163697|NCT00246259|Secondary|Number of Participants With Cognitive Assessments Using Trail B|Cognitive assessments were done using Trail test B, which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. In Trail B, 2 sets of circles contain numbers and letters, and the participant must connect them in alternating order. Trail B is also a measure of executive functions as it requires planning and decision-making.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.||Participants|||Number
163698|NCT00246259|Secondary|Number of Participants With Cognitive Assessment Using Trail A|Cognitive assessments were done using Trail test A which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. Participants must connect numbered circles in a variety of orders.|Week -2, 104 or LRV|The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.||Participants|||Number
163699|NCT00246259|Secondary|Percentage of Participants With Relapse|"Relapse was defined according to Csernansky: “Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as CGI-C score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) = participants evaluable for this measure.||Percentage of participants|||Number
163700|NCT00246259|Secondary|Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV|The HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. Total score ranges from 0 to 56. Lower score indicates less affected.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
163701|NCT00246259|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV|Co-morbid symptoms of mania are evaluated by change in YMRS Score which is an 11-item scale to assess symptoms of mania, Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (the least) to 60 (the worst).|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
163703|NCT00246259|Primary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV|The SOFAS focused exclusively on participants’ level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.|Baseline, Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
163704|NCT00246259|Primary|Time to Relapse|"Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: “Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse)."|Week 10 (post-stability) up to Week 104 or LRV|The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment.||Weeks||Standard Deviation|Mean
163705|NCT00246259|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 104 or LRV|Intent-to-treat (ITT) analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. One participant was missing as reported in oral antipsychotic arm. 'n' = participants evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
163706|NCT00246090|Secondary|Duration of Response|Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.|From first documented complete or partial response until disease progression or death|Eligible Population||Days||Full Range|Median
163707|NCT00246090|Primary|Objective Response Rate|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Every two cycles|Eligible Population||Percentage of Participants|||Number
163708|NCT00246025|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|||participants|||Number
163709|NCT00246025|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 0|Safety set||mL||Standard Deviation|Mean
163710|NCT00246025|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 0|Safety set||participants|||Number
163711|NCT00246025|Secondary|Number of Participants With Bleeding Events During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|2 weeks|Safety set - Safety set includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.||participants|||Number
163712|NCT00246025|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee.|2 weeks|FAS−op||percentage of participants|||Number
163713|NCT00246025|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.|2 weeks|FAS−op||percentage of participants|||Number
163714|NCT00246025|Secondary|Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Total DVT during treatment period|2 weeks|FAS−tDVT - FAS−tDVT includes all patients who were randomised, treated, operated, and had evaluable venogram or confirmed symptomatic DVT.||percentage of participants|||Number
163715|NCT00246025|Secondary|Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)|Number of Participants expressing DVT with symptoms|2 weeks|FAS−op - FAS−op includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.||Percentage of participants|||Number
163716|NCT00246025|Secondary|Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period|Number of participants who have Proximal DVT during treatment period|2 weeks|FAS−pDVT - FAS−pDVT includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT.||percentage of participants|||Number
163717|NCT00246025|Secondary|Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality|Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality|2 weeks|FAS-major - FAS-major includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT, PE, or VTE-related death.||percentage of participants|||Number
163718|NCT00246025|Primary|Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.|number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality|2 weeks study medication|Full analysis set (FAS) - Full analysis set includes all patients who were randomly assigned to the treatment, received at least one oral dose, went through surgery, had an evaluable venogram for distal and proximal DVT, or had confirmed symptomatic DVT or PE, or died.||percentage of participants|||Number
163885|NCT00243386|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||dL/kg||Standard Deviation|Mean
163719|NCT00246012|Other Pre-specified|Percentage of Participants Who Achieved a Best Overall Response as CR, PR, or SD - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50% or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure.|Within 28 days of first infusion of study medication, within 1 week of the end of Cycles 2, 4, 6, 8; 3 months and 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
163720|NCT00246012|Other Pre-specified|Area Under the Concentration Versus Time Curve Between Zero to Infinite Time (AUCinf) of Intetumumab - Phase 1 (Part 1)|The AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg*day/mL||Standard Deviation|Mean
163721|NCT00246012|Secondary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 2)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.|||||
163722|NCT00246012|Secondary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/kg||Standard Deviation|Mean
163723|NCT00246012|Secondary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/day/kg||Standard Deviation|Mean
163724|NCT00246012|Secondary|Half-life of Intetumumab - Phase 1 (Part 2)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Days||Standard Deviation|Mean
163725|NCT00246012|Secondary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg*day/mL||Standard Deviation|Mean
163726|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
163727|NCT00246012|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2|The BPI questionnaire is used to evaluate heath related quality of life. BPI allows participants to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
163728|NCT00246012|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2|The FACT-MS subscale is used to evaluate health related quality of life. It consists of 16 items: 12 items related to physical well-being, 3 to emotional well-being and 1 to social well-being. Scores for all items will range from 0 to 4. Total score ranges from 0-64; higher score indicates a more positive quality of life.|Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)|The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.||Units on a scale||Standard Deviation|Mean
163729|NCT00246012|Secondary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.||mcg/mL||Standard Deviation|Mean
163793|NCT00244881|Primary|Fraction of Patients With Increased Levels of Circulating Endothelial Cells|An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).|After 3 weeks of treatment|||percentage of participants|||Number
163730|NCT00246012|Secondary|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2|Eastern Cooperative Oncology (ECOG) performance status: Participants will be graded from 0 (Fully active, able to carry on all pre-disease activities without restriction) to 4 (Completely disabled, cannot carry on any self-care, totally confined to bed or chair). Worsening in ECOG score was defined as ≥ 1 point increase in ECOG score from baseline.|Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.||Days||95% Confidence Interval|Median
163731|NCT00246012|Secondary|Duration of Response - Phase 2|Time duration required to achieve a CR or PR.|From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication|The response-evaluable population included all the participants who were evaluable for response. The results were reported as individual participant’s listings, but not statistically summarized.|||||
163732|NCT00246012|Secondary|Overall Survival (OS) - Phase 2|The OS is defined as the time from the date of randomization to the date of death due to any cause and was to be censored at the date that the subject is last known to be alive.|Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication|The ITT population included all the participants who were randomly assigned to treatment.||Days||95% Confidence Interval|Median
163733|NCT00246012|Secondary|Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2|The SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as a reference the smallest sum longest diameter since the treatment started. The participants who achieved SD as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
163734|NCT00246012|Secondary|Percentage of Participants Who Achieved CR - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
163735|NCT00246012|Secondary|Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2|The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported.|Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)|The response-evaluable population included all the participants who were evaluable for response.||Percentage of Participants|||Number
163736|NCT00246012|Primary|Progression-Free Survival (PFS) - Phase 2|The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions.|From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication|The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment.||Days||95% Confidence Interval|Median
163737|NCT00246012|Primary|Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1)|The R is obtained by dividing AUC at two different time points.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.|||||
163738|NCT00246012|Primary|Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/kg||Standard Deviation|Mean
163739|NCT00246012|Primary|Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mL/day/kg||Standard Deviation|Mean
163740|NCT00246012|Primary|Half-life of Intetumumab - Phase 1 (Part 1)|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Days||Standard Deviation|Mean
163845|NCT00243919|Primary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|12 months post-stroke|Intention to treat analysis. Missing data were imputed using the LOCF method.||percent of participants|||Number
163741|NCT00246012|Primary|Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1)|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||mcg*day/mL||Standard Deviation|Mean
163742|NCT00246012|Primary|Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1)|The maximum observed analyte concentration in serum was reported.|Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose|The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
163743|NCT00246012|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1|The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.|Up to 21 days post-first infusion from the last treated participant in Phase 1|Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine.||Participants|||Number
163744|NCT00245960|Secondary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease.|Efficacy measured by the number of subjects achieving Psoriatic Arthritis response criteria at 24 weeks last observed carried forward (LOCF).|24 weeks|The analysis population was the Modified Intent to Treat (mITT).||participants|||Number
163745|NCT00245960|Primary|Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis.|Efficacy measured by the number of subjects with a Physician Global Assessment of Psoriasis of clear or almost clear at 12 weeks last observation carried forward (LOCF).|12 weeks|The analysis population was the Modified Intent to Treat (mITT) population.||participants|||Number
163746|NCT00245856|Secondary|Bleeding Events|Total major bleeding rate|3 months|All DVT treated patients analyzed together||participants||95% Confidence Interval|Number
163747|NCT00245856|Primary|New Venous Thromboembolism at 3 Months|New DVT or PE at 3 months confirmed by diagnostic testing|3 months|All DVT treated patients analyzed together||participants||95% Confidence Interval|Number
163748|NCT00245856|Primary|Percentage of Participants That Died at 3 Months||3 months|All DVT treated patients analyzed together||percentage of participants||95% Confidence Interval|Number
163749|NCT00245635|Primary|Change in Total Score on the BDD-Y-BOCS Scale|To assess the change in total score on the Body Dysmorphic Disorder-Yale-Brown Obsessive Compulsive Scale (BDD-Y-BOCS) from baseline (visit 0) to endpoint (week 12). This is a 12-item scale that assesses obsessions and compulsions related to the patient's BDD. Each item's score ranges from 0 to 4, with a total possible score of 48 on the full assessment. Scores of 0 indicate no impairment, while scores of 4 indicate maximum impairment. Thus higher scores are considered to be a worse outcome.|Baseline compared to the study endpoint (week 12) [two time points]|||units on a scale||Standard Deviation|Mean
163750|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
163751|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose|"The time to recovery from maximum percent fall is the~duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the~time when FEV1 returns to within 5% of the preexercise baseline for the first time."|Exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
163752|NCT00245570|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
163753|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||Percent * minutes||Standard Deviation|Mean
163754|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose|The measure included only the area below the pre-exercise baseline|0-60 minutes after the exercise challenge at 8.5 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||Percent * minutes||Standard Deviation|Mean
163795|NCT00244764|Secondary|Duration of Response|Using RECIST criteria: date of first confirmed tumor response (CR or PR) to date of tumor progression or to death. Participants who did not progress or die were censored at their last radiologic assessment. Only participants who had a response were analyzed.|First response until progression of disease (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All participants in the Enrolled Population who had a CR or PR||weeks||95% Confidence Interval|Median
163755|NCT00245570|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|"The measure included only the area below the pre-exercise~baseline"|0-60 minutes after the exercise challenge at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||Percent * minutes||Standard Deviation|Mean
163756|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change from Baseline||Standard Deviation|Mean
163757|NCT00245570|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose|The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change from Baseline||Standard Deviation|Mean
163758|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
163759|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose||0-90 minutes after the exercise challenge performed at 8.5 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
163760|NCT00245570|Secondary|Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
163761|NCT00245570|Primary|Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change from Baseline||Standard Deviation|Mean
163762|NCT00245557|Primary|MRS (Magnetic Resonance Spectroscopy)||at week 13||12/2015||||
163763|NCT00245557|Primary|Geriatric Depression Scale|This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms).|baseline at study entry week 0||12/2015||||
163764|NCT00245557|Primary|HAM-D 17 (Hamilton Depression Rating Scale)|"This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness.~Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms)."|baseline at study entry week 0|||Units on a scale||Standard Deviation|Mean
163765|NCT00245466|Secondary|Serum Levels of Testosterone After 1, 2, and 3 Years||3 years|||nanogram per milliliter||Full Range|Median
163766|NCT00245466|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS02) and the extension study (FE200486 CS02A).||participants|||Number
163767|NCT00245466|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS02) and the extension study FE200486 CS02A.||participants|||Number
163768|NCT00245219|Primary|Depressive Symptoms (as Measured With the CES-D) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 29 (high levels of depressives symptoms) in the present sample. For the sake of analyses, CES-D scores were dichotomized (cutoff score of 8), because scores exhibited marked positive skew in the present sample.|Baseline, Time 2 (2 Weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.||units on a scale||Standard Deviation|Mean
163794|NCT00244764|Secondary|Progression-free Survival|Progression-free Survival is defined as the interval between the first day of treatment and the earliest date of disease progression or death due to any cause, whichever occurred first. Progressive disease is defined as a >=20% increase in target lesions.|From the first day of treatment to the earliest date of disease progression or death due to any cause (up to 2.40 years)|All Enrolled Population. Participants who did not progress or die were censored at their last radiologic assessment.||weeks||95% Confidence Interval|Median
163769|NCT00245219|Primary|Perceived Physical Health (as Measured With the SF36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Physical Functioning, Bodily Pain, Role Limitations due to Physical Problems and General Health. In the present study, scores ranged from a maximum of 70 (high levels of perceived health) to a minimum of 12 (low levels of perceived health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.||units on a scale||Standard Deviation|Mean
163770|NCT00245219|Primary|Mental Health (as Measured With the SF-36) at Baseline, Time 2 (2 Weeks Post-intervention) and Time 3 (6 Months Post-intervention)|The Mental Health Component Scale of the Medical Outcomes Study Short Form 36(SF-36) consists of a norm-based weighted average of the following subscales: Vitality, Social Functioning, Role Limitations due to Emotional Problems and Mental health. In the present study, scores ranged from a maximum of 72 (high levels of mental health) to a minimum of 12 (low levels of mental health).|Baseline, Time 2 (2 weeks post-intervention) and Time 3 (6 months post-intervention)|The intention-to-treat principle was followed, all participants were included in the analyses regardless of number of meetings attended.||units on a scale||Standard Deviation|Mean
163771|NCT00245128|Secondary|Reduction in Marrow Fibrosis and Decrease in Spleen Size||After 6 and 12 months of therapy||||||
163772|NCT00245128|Primary|Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy|"A major response = transfusion independent or a>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks.~Minor response= > 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period."|At 3,6, and 12 months of therapy|||percentage of participants|||Number
163773|NCT00245102|Primary|Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST|A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.|Up to 4 weeks|||participants|||Number
163774|NCT00245063|Primary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 weeks|||percentage of responding patients|||Number
163775|NCT00245050|Secondary|Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)|QOL was measured with the FACT-G questionnaire following the third course of doxorubicin HCl liposome before the patient was seen by the treating physician and before chemotherapy was administered. The FACT-G, version 4, is a 27-item core questionnaire evaluating the domains of physical, functional, family-social, and emotional well-being (PWB, FWB, SWB, EWB). Total score ranges from 0-108 and higher scores indicate better QOL.|After Cycle 3 of chemotherapy (on average at 3 months)|||Total scores on FACT-G scale||Standard Deviation|Mean
163776|NCT00245050|Primary|Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)|Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific doxorubicin HCl liposome related toxicities using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.|Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.|Patients were evaluable for PPE/HFS(Hand-Foot Syndrome) incidence and toxicity assessment if they received at least one course of chemotherapy. Intention to treat analysis was used.||participants|||Number
163777|NCT00245011|Secondary|Correlative Dose of Radiation by Low Dose and High Dose Samarium-153||completion of treatment||||||
163778|NCT00245011|Secondary|Long Term Side Effects of Infusional Samarium-153 After Study Treatment||Continual||||||
163779|NCT00245011|Secondary|Toxicity at End of Study Treatment||Continual and at End of Study||||||
163780|NCT00245011|Secondary|Overall and Progression-free Survival After Study Treatment||Continual||||||
163781|NCT00245011|Secondary|Predictive Value of Imaging Studies||At Time of Tumor Resection||||||
163782|NCT00245011|Primary|Tumor Response|WHO (World Health Organization) tumor measurement criteria used to determine response.|1 week after study treatment|11 subjects, heavily treated with chemotherapy with osteosarcoma metastatic to bone were enrolled; 10 evaluable for response. Mean age: 18 years. Age range was14-30 years.||participants|||Number
163783|NCT00244933|Secondary|In Vivo Effects of Genistein in Breast Cancer Tissue Biomarkers (Ki67, TUNEL Assay, p-Akt, NF-kB, Immunohistochemistry and cDNA Microarray Analysis)||At baseline (pre-genistein treatment) and 7 days following genistein treatment||||||
163784|NCT00244933|Secondary|Correlate Responses With Plasma Genistein Levels||At course 1 day -7, course 1 day -1 (before and 4 hours after dose), course 2 day 1 (before and 4 hours after dose)||||||
163785|NCT00244933|Secondary|Qualitative and Quantitative Toxicities||30 days following treatment||||||
163786|NCT00244933|Secondary|Duration of Survival||At 1 year following study treatment||||||
163787|NCT00244933|Secondary|Time to Disease Progression||From the time that treatment is initiated until the time restaging indicates progressive disease.||||||
163788|NCT00244933|Secondary|Overall Survival||From the time the last patient comes off study treatment for one year to monitor survival||||||
163789|NCT00244933|Secondary|Duration of Response||From the time the last patient comes off study treatment for one year||||||
163790|NCT00244933|Primary|Objective Response Rate by RECIST Criteria Following|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 2 courses until disease progression or death, up to 24 weeks|||participants|||Number
163791|NCT00244881|Secondary|Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD||12 weeks|||percentage of participants|||Number
163792|NCT00244881|Primary|Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria|RECIST 1.0 Criteria|Up to 7 years|||percentage of participants||95% Confidence Interval|Number
163796|NCT00244764|Primary|Stable Disease at 12 Weeks - Interim Analysis of First 60 Participants|The protocol called for an interim analysis of the first 60 participants to determine their status at Week 12, and to determine the number of participants with stable disease, although all categories were reported. Stable disease is defined as a disease that has not grown enough to be called progressive disease and has not shrunk enough to be called partial/complete response.|Week 12|Subset of the All Enrolled Population including only the first 60 participants||participants|||Number
163797|NCT00244764|Primary|Overall Response by RECIST Criteria|The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a >=20% increase in target lesions, Stable Disease = small changes that do not meet previously given criteria.|Baseline to Response (up to 2.40 years). Assessments occurred at Week 12 and every 8 weeks thereafter.|All Enrolled: all participants who received at least one dose of pazopanib||participants|||Number
163798|NCT00244712|Secondary|Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction|The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.|Baseline through 96 weeks|The Safety population which included all randomized participants who received at least one dose of study medication.||participants|||Number
163799|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.||participants|||Number
163800|NCT00244712|Secondary|Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks|A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|Baseline and time of virologic failure (up to Week 96)|Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations||participants|||Number
163801|NCT00244712|Secondary|Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96|The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.|Baseline to Week 96|The Intent-To-Treat-Exposed (ITT-E) population||participants|||Number
163802|NCT00244712|Secondary|Median Change From Baseline in CD4+ Cells at Weeks 48 and 96|A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.||cells per cmm||Full Range|Median
163803|NCT00244712|Secondary|Median Change From Baseline in HIV-1 RNA at Week 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.||log10 copies/mL||Full Range|Median
163804|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
163805|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
163806|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
163807|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
163842|NCT00243919|Secondary|6 Month Outcome: Walking Speed: Measured During a 10-meter Walk||Baseline and 6 months post-stroke|||m/sec||Standard Deviation|Mean
163917|NCT00243061|Secondary|Toxicity as Assessed by NCI CTCAE Version 3.0||Up to 6 years after completion of treatment||||||
163808|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.|Weeks 48 and 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F||percentage of participants|||Number
163809|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 96|The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.||percentage of participants|||Number
163810|NCT00244712|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.||percentage of participants|||Number
163811|NCT00244712|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).|Week 48|The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA >=50 copies/mL.||percentage of participants|||Number
163812|NCT00244621|Secondary|Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28|||Percent change||Inter-Quartile Range|Median
163813|NCT00244621|Secondary|Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28||From randomisation to day 28|||Percent change||Inter-Quartile Range|Median
163814|NCT00244621|Secondary|Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)||From randomisation to end of double-blind treatment (4 weeks)|||mm Hg||Standard Deviation|Mean
163815|NCT00244621|Primary|Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)||From randomisation to end of double-blind treatment (4 weeks)|||mm Hg||Standard Deviation|Mean
163816|NCT00244374|Secondary|HIV Vaccine Trial Knowledge|"Participants were asked if they agreed or disagreed with or were unsure of each of eight statements about HIV vaccine trial concepts from the HIV Network for Prevention Trials (HIVNET).~Preventive HIV vaccine studies enroll people who are HIV-positive and HIV-negative.~Some participants in HIV vaccine studies will get a real vaccine, and some will get a placebo (an inactive substance).~Only vaccines known to be at least 50% effective at preventing HIV are tested in HIV vaccine studies.~Once a large scale HIV vaccine study begins, we can be sure the vaccine is completely safe.~Participants are told whether they got the HIV vaccine or the placebo at the end of HIV vaccine studies.~HIV vaccines will never affect a person's HIV test results.~An HIV vaccine can infect a person with HIV disease.~People in vaccine studies know whether or not they got the placebo because only the vaccines cause side effects."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data||Participants|||Number
163817|NCT00244374|Secondary|HIV Vaccine Trial Willingness|"We assessed knowledge about vaccine trials and willingness to participate in preventive HIV vaccine trials by asking the question: How willing would you be to join a study of a vaccine to prevent HIV infection, if the study were to start tomorrow?. Willingness was measured on a 4-point response scale, ranging from 1 (Definitely not willing) to 4 (Definitely willing)."|Baseline|Per the Participant Flow, 409 participants in the cross-sectional study had complete and valid baseline data||Participants|||Number
163818|NCT00244374|Secondary|Viral Transmission Risk Behavior Association With Travel|In a cross-sectional analysis of 355 subjects enrolled between 2004 and 2006, we estimate the associations between travel in the 3 months prior to baseline and behaviors occurring in the 30 days prior to baseline, such as drug and alcohol and sexual behaviors, that may facilitate the spread of viral infections.|Baseline|Cross-sectional analysis of 355 subjects enrolled between 2004 and 2006||percentage of participants|||Number
163819|NCT00244374|Secondary|Hepatitis B Surface Antibody Seroconversion After 3 Vaccine Doses|To examine the effect of hepatitis C virus (HCV) infection on vaccine effectiveness, we compared anti-HBs (antibody to the hepatitis B surface antigen) seroconversion after three vaccine doses between anti-HCV (antibody to the hepatitis C virus) positive and anti-HCV negative participants.|12 months|139 participants who completed 3 vaccine doses were included in the analysis. Enrollment for this aim continued after enrollment into the 12-month vaccine adherence trial closed; an additional 51 persons were found eligible and enrolled.||Participants|||Number
163820|NCT00244374|Primary|Vaccine Series Completion|The primary outcome was the completion of the four-dose vaccine series in a 12 month period.|12 months|||participants|||Number
163821|NCT00244140|Secondary|The Ability of the Blinded Readers to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the 3 blinded readers.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of diagnostic CECTs|||Number
163843|NCT00243919|Secondary|Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke|Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.|Baseline and 6 months post-stroke|Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.||percent of participants|||Number
163822|NCT00244140|Secondary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Investigators' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by the investigators. QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of participants in QOI grade|||Number
163823|NCT00244140|Secondary|The Ability of the Investigator to Make a Diagnosis Based on the CECT Images|The number of participants with diagnostic CECTs as assessed by the investigators.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of diagnostic CECTs|||Number
163824|NCT00244140|Primary|The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment.|A subjective assessment of the 'Quality of Image' (QOI) by 3 blinded readers (BR). QOI-Grades used: Excellent - Good - Poor.|post administration assessment of study images|The primary efficacy analysis used the Full Analysis Set (FAS), which consisted of the subjects who received any amount of iopromide regardless of any protocol deviation, excluding the sample subjects and subjects who did not have CT images. In the FAS, 402 subjects were included.||Number of participants in QOI grade|||Number
163825|NCT00244101|Secondary|Parental Questionnaire for Health Status||at 24 months of age||||||
163826|NCT00244101|Secondary|Days in Hospital||prior to hospital discharge||||||
163827|NCT00244101|Secondary|Days of Ventilator Support||prior to hospital discharge||||||
163828|NCT00244101|Secondary|Complications of Prematurity||prior to hospital discharge||||||
163829|NCT00244101|Primary|Death||36 weeks adjusted age||||||
163830|NCT00244101|Primary|Death or Chronic Lung Disease||at 36 weeks postmenstrual age|intention to treat analysis||participants|||Number
163831|NCT00244010|Primary|Treatment Failures|The primary objective of this study is to evaluate the safety of HAPLO HSCT for patients with refractory severe aplastic anemia (SAA) or refractory cytopenias. The treatment plan would be considered unsafe if we can demonstrate that it is associated with a significantly higher treatment failure rate. The treatment failure is defined as any occurrence of the following events, overall grade III-IV acute GVHD, graft failure or death due to any cause within 100 days post HSCT or after the last cellular product infusion, if required.|100 days post transplant|Enrollment was terminated due to the PI leaving the institution. Insufficient data was generated to answer the objective.||Participants|||Number
163832|NCT00243932|Primary|Change in the ALS Functional Rating Scale-revised (ALSFRSr) Score.|The ALSFRSr, a questionnaire-based scale assessing daily living function ranging from 48 (best score) to 0 (worst), was administered to the patient, or to a proxy if the patient could not communicate effectively. Decline was defined as ALSFRSr at baseline minus ALSFRSr at month 9. Thus a positive value indicates worsening.|9 months|||units on a scale||Standard Deviation|Mean
163833|NCT00243932|Secondary|The Change Over 9 Months in Forced Vital Capacity; Fatigue Severity Scale; Short Form-36; and 8OH2dG (a Biomarker of Oxidative Stress Measured in a Blood Sample).||9 months||||||
163834|NCT00243919|Secondary|Activities Specific Balance Confidence (ABC) Score|Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
163835|NCT00243919|Secondary|Berg Balance Score|Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
163836|NCT00243919|Secondary|Fugl-Meyer Lower Extremity Score|Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
163837|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Mobility|Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
163838|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)|Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
163839|NCT00243919|Secondary|Stroke Impact Scale (SIS) - Participation|Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL–IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities.|Baseline, 6 months and 12 months post-stroke|||units on a scale||Standard Deviation|Mean
163840|NCT00243919|Secondary|Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day|As measured with a step activity monitor averaged over 2 days.|Baseline, 6 months and 12 months post-stroke|||steps||Inter-Quartile Range|Median
163841|NCT00243919|Secondary|6 Minute Walking Distance (Meters)|Distance walked in 6 minutes.|Baseline, 6 months and 12 months post-stroke|||meters||Standard Deviation|Mean
163846|NCT00243659|Secondary|Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge|Assessment of hemostatic efficacy by the investigator at the day of discharge from the hospital using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit five.||patients|||Number
163847|NCT00243659|Primary|Number of Patients Who Achieved Hemostatic Efficacy After Surgery|Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.|6 weeks|The analysis population is the efficacy evaluable at visit three.||patients|||Number
163848|NCT00243503|Secondary|Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.||ng/mL||Standard Deviation|Mean
163849|NCT00243503|Secondary|Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The PK population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.||ng/mL||Standard Deviation|Mean
163850|NCT00243503|Secondary|Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib|Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.|Predose on Day 1 of Cycle 3 and 5|The Pharmacokinetic (PK) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib) and collected plasma values.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
163851|NCT00243503|Secondary|EORTC QLQ (BR23)|BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||scores on a scale||Standard Deviation|Mean
163852|NCT00243503|Secondary|EORTC QLQ-C30|EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||scores on a scale||Standard Deviation|Mean
163853|NCT00243503|Secondary|Probability of Survival at One Year|One- year survival probability was estimated using the Kaplan-Meier method.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||percentage of 1-year survival||95% Confidence Interval|Number
163854|NCT00243503|Secondary|Overall Survival (OS)|Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.|From start of study treatment until death or 2 years from first study treatment|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||months||95% Confidence Interval|Median
163855|NCT00243503|Secondary|Time to Progression (TTP)|Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||weeks||95% Confidence Interval|Median
163856|NCT00243503|Secondary|Progression Free Survival (PFS)|Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||Weeks||95% Confidence Interval|Median
163857|NCT00243503|Secondary|Percentage of Participants With Clinical Benefit|Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.|From start of treatment through 18 months|The ITT population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||Percentage of Participants||95% Confidence Interval|Number
163858|NCT00243503|Secondary|Duration of Response (DR)|Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.|From start of treatment through 18 months|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response.||weeks||95% Confidence Interval|Median
163859|NCT00243503|Primary|Percentage of Participants With Overall Confirmed Objective Disease Response|Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.|From start of treatment through 18 months|The intent-to-treat (ITT) population included all enrolled participants who were treated with the combination (trastuzumab and sunitinib).||percentage of participants||95% Confidence Interval|Number
163860|NCT00243412|Secondary|Change From Baseline in Cyclic Citrullinated Peptide (CCP) Antibodies/Cytokines|Because of the different laboratory methods that were used to measure anti-CCP antibody levels, no summary statistics were calculated.|Baseline, 24 Months|||units|||Number
163861|NCT00243412|Secondary|Change From Baseline in Rheumatoid Factor (RF)|Serum levels of rheumatoid factor at baseline, month 24 and change from baseline to month 24.|Baseline, 24 Months|Participants from the Safety-Evaluable population for whom data was available at baseline and month 24.||IU/mL||Standard Deviation|Mean
163862|NCT00243412|Secondary|DAS28-4 Erythrocyte Sedimentation Rate(ESR)|The DAS28-4(ESR) score is a measure of the subject’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease In this trial, CRP rather than ESR was used, unless the CRP value was missing at both Day 1 and screening, in which case ESR value was used.|24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
163863|NCT00243412|Secondary|Change From Baseline in Functional Assessment for Chronic Illness Therapy–Fatigue (FACIT-F)|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient’s response to the questions (with the exception of 2 negatively stated), the greater the patient’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient’s health status.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
163864|NCT00243412|Secondary|Change From Baseline in Health Assessment Questionnaire–Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in a certified translation of the local languages at the participating sites and was scored based on the instructions from the Stanford University Medical Center.The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
163865|NCT00243412|Secondary|Change From Baseline in Short Form 36 (SF 36) Summary and Subscale Scores|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning (PF), Role Physical (RP), Bodily Pain(BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE),Mental Health (MH). Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score.|Baseline, 24 Months|Participants from the Intent−to−Treat (ITT) for whom data was available at baseline and month 24.||Units on a Scale||Standard Deviation|Mean
163866|NCT00243412|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response and Remission Using Disease Activity Score 28–4 (DAS28-4)C-reactive Protein (CRP)|"EULAR remission = DAS28-4(CRP) < 2.6 (Fransen et al. 2004.~EULAR response categories (van Gestel et al. 1999):~Good response = final DAS28-4(CRP) < 3.2 and decreased > 1.2 points from baseline Moderate response = final DAS28-4(CRP) ≥ 3.2 but ≤ 5.1 and decreased > 0.6 points from baseline or final DAS28-4(CRP) > 5.1 and decreased > 1.2 from baseline."|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Participants|||Number
163867|NCT00243412|Secondary|Number of Participants With American College of Rheumatology (ACR) Major Clinical Response and/or Remission|"Major clinical response is an ACR70 response defined as improvement from baseline: ≥70% in tender joint count; ≥70% in swollen joint count; ≥70% in 3 of the following: Patient Pain Assessment, Patient Global Assessment, Physician Global Assessment, Patient Self-Assessed Disability, ESR or CRP for ≥169 consecutive days.~Remission: ≥5 requirements fulfilled for ≥2 consecutive months: Duration of morning stiffness <15 minutes, No fatigue, No joint pain, No joint tenderness or pain on motion, No soft tissue swelling in joints or tendon sheaths, ESR <30 mm/hour for women and <20 mm/hour for men."|24 months|Intent−to−Treat (ITT)||Participants|||Number
163868|NCT00243412|Secondary|Number of Participants With American College of Rheumatology Responses (ACR20, ACR50, and ACR70)|"ACR20 response was defined as satisfying the following 3 criteria improvement from baseline: ≥ 20% in tender joint count; ≥ 20% in swollen joint count; ≥ 20% improvement from baseline in 3 of the following 5 criteria:~Subject’s Global Assessment of Pain Subject’s Global Assessment of Disease Activity Physician’s Global Assessment Subject’s Self-Assessment Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) Note: The definitions of ACR50 and ACR70 are the same as ACR20, except that the 20% value in the above definition is replaced by 50% and 70% values, respectively."|Baseline, 24 months|Intent−to−Treat (ITT)||Participants|||Number
163882|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to Investigational Product (IP)|Number of treated participants with 1 or more AE regardless of relatedness to IP|Throughout study period (4 years and 5 months)|Safety Analysis Set||Participants|||Number
163883|NCT00243386|Secondary|Number of Participants With AEs Related to Investigational Product (IP)|Number of treated participants with AEs judged to be possibly or probably related to treatment with IP|Throughout study period (4 years and 5 months)|Safety Analysis Set||Participants|||Number
163869|NCT00243412|Secondary|Change From Baseline in Disease Activity Score 28-4 C-reactive Protein (DAS28-4(CRP))|The DAS28-4(CRP) score is a measure of the subject’s disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient’s global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity. Change from baseline at 24 months was analyzed for DAS28-4 (CRP).|Baseline, 24 months|Participants from the Intent−to−Treat (ITT) population for whom data was available at baseline and month 24.||Scores on a scale||Standard Deviation|Mean
163870|NCT00243412|Primary|Number of Participants With Either an Infection or a Grade III or IV Adverse Event (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE], Version 3.0)|"A Grade III Adverse Event (AE) is severe; defined as considerable interference with the subject’s daily activities, medical intervention/therapy required and hospitalization possible.~A Grade IV AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, hospitalization probable.~Because of the small sample size and the small number of subjects who completed Week 104, the analysis were limited to descriptive statistics only."|24 months|Safety−Evaluable Population||Participants|||Number
163871|NCT00243386|Post-Hoc|Median (IQR) Annualized Bleed Rates|Bleed rates (number of bleeding episodes per subject) were annualized to account for the varying number of days a subject may have actually been on each regimen.|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Per-Protocol Efficacy Analysis Set||Bleeding episodes||Inter-Quartile Range|Median
163872|NCT00243386|Secondary|Physical Component Scores (PCS) HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) – (End of prophylaxis regimen) A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age||Scores on a scale||Full Range|Median
163873|NCT00243386|Secondary|Bodily Pain HRQoL Scores Change From On-Demand Period Through Prophylaxis Period|"Change = (End of on-demand treatment) – (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen.~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic analysis set for participants ≥14 years of age||Scores on a scale||Full Range|Median
163874|NCT00243386|Primary|Median Annualized Bleed Rate Estimates From Each of the 1 Year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):~Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.~PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat||Bleeds per year||Full Range|Median
163875|NCT00243386|Secondary|HRQoL Scores Change From On-Demand Treatment Regimen Period Through Prophylaxis Period|"Differences in health domain scores = (End of on-demand treatment) – (End of prophylaxis regimen). A negative value for the median difference equates to a larger domain score for the prophylaxis regimen~Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS).~Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores."|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set ≥14 Years and Older||Scores on a scale||Full Range|Median
163876|NCT00243386|Secondary|Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS at the End of Treatment Regimens|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|End of on-demand treatment period (6 months) and at study termination (approximately 18 months)|Pharmacoeconomic Analysis Set||Scores on a scale||Full Range|Median
163877|NCT00243386|Secondary|Baseline Health-related Quality of Life (HRQoL) Scores: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Baseline SF-36v1 Scores, where data available. Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline|Safety Analysis Set||Scores on a scale||Full Range|Median
163878|NCT00243386|Secondary|Number of Participants With Severe SAEs and Severe Non-SAEs by Preferred MedDRA Term and Treatment Regimen|This outcome is focused only on SEVERE SAEs and SEVERE non-SAEs|Throughout the study period (4 years and 5 months)|Safety Analysis Set||participants|||Number
163879|NCT00243386|Secondary|AEs With Onset ≤1 Hour Following the End of an Infusion, Regardless of Relatedness||Throughout study period (4 years and 5 months)|Safety Analysis Set||Events|||Number
163880|NCT00243386|Secondary|Number of Participants With SAEs by Preferred MedDRA Term and Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set||participants|||Number
163881|NCT00243386|Secondary|Number of Participants Who Reported ≥1 AE Regardless of Relatedness to IP by Treatment Regimen||Throughout the study period (4 years and 5 months)|Safety Analysis Set||participants|||Number
163884|NCT00243386|Secondary|Factor VIII Inhibitor Development|Number of treated participants who developed factor VIII inhibitors|Throughout study period (4 years and 5 months)|Safety Analysis Set||Participants|||Number
163886|NCT00243386|Secondary|Mean Residence Time|Computed as total Area Under the Moment Curve (AUMC) divided by the total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
163887|NCT00243386|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||mL/(kg*h)||Standard Deviation|Mean
163888|NCT00243386|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||hours||Standard Deviation|Mean
163889|NCT00243386|Secondary|Adjusted Incremental Recovery (IR)|"Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.~Adjusted IR defined as:~[Cmax (IU/dL) – pre-infusion FVIII (IU/dL)]/dose (IU/kg)"|30 minutes pre-infusion to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU/dL per IU/kg||Standard Deviation|Geometric Mean
163890|NCT00243386|Secondary|Maximum Plasma Concentration (C-max)|Maximal Factor VIII Concentration After Infusion|Within 1 hour post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU/dL||Standard Deviation|Geometric Mean
163891|NCT00243386|Secondary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU*h/dL||Standard Deviation|Geometric Mean
163892|NCT00243386|Secondary|Total Area Under the Curve (AUC)|Total AUC estimated by AUC 0-48h plus an area extrapolated from the log-linear regression model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Intent to Treat Pharmacokinetic Analysis Set||IU*h/dL||Standard Deviation|Geometric Mean
163893|NCT00243386|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~8 hrs after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Hemostatic Efficacy Rating Analysis Set (Participants with bleeding episodes that were rated)||bleeding episodes|||Number
163894|NCT00243386|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Throughout the study period (4 years and 5 months)|Intent to Treat Efficacy Set||Bleeding episodes|||Number
163895|NCT00243386|Secondary|Total Weight-Adjusted Dose of rAHF-PFM Used Per Year for Each Prophylaxis Arm|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Part 2 of the study):~Standard prophylaxis- infusions every 48 ±6 hours, dosed at 20 to 40 IU/kg.~PK-driven prophylaxis- infusions every 72 ±6 hours dosed at 20 to 80 IU/kg."|12 months ±2 weeks|Intent to treat||IU/kg||Inter-Quartile Range|Median
163896|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Any Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Any Prophylaxis Treatment TABR).~Any Prophylaxis = Standard or PK-Driven Prophylaxis~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); Prophylaxis 12 months (± 2 weeks)|Intent to treat||(bleeds/year)^(1/2)||Standard Deviation|Mean
163897|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and PK-Driven Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (PK-Driven Prophylaxis Treatment TABR)~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat||(bleeds/year)^(1/2)||Standard Deviation|Mean
163898|NCT00243386|Secondary|Mean Difference of Transformed Annualized Bleeding Rate Between On-Demand and Standard Prophylaxis Treatment Regimens|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the paired t-test.~Mean Difference of Transformed Annualized Bleeding Rate (TABR) = (On-Demand Treatment TABR) - (Standard Prophylaxis Treatment TABR).~Participants from the On-Demand portion of the study were subsequently randomized to either Standard Prophylaxis or PK-Driven Prophylaxis, (i.e the same participants were analyzed across the two measurement time periods)."|On-demand 6 months (± 2 weeks); followed by Prophylaxis 12 months (± 2 weeks)|Intent to treat||(bleeds/year)^(1/2)||Standard Deviation|Mean
163899|NCT00243386|Primary|Mean Transformed Annualized Bleed Rate Estimates From Each of the 1-year Prophylaxis Regimens|"Participants were Randomized to Receive 1 of the 2 Following Prophylaxis Regimens (Study Part 2):~Standard prophylaxis (20-40 IU/kg (every 48 ±6 hour), exact regimen determined by investigator)~PK-driven prophylaxis (20-80 IU/kg (every 72 ±6 hour), exact regimen determined by sponsor)~Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X = bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test."|12 months ±2 weeks|Per Protocol||(bleeds/year)^(1/2)||Standard Deviation|Mean
163900|NCT00243347|Secondary|Change From Baseline in Mean Arterial Blood Pressure (MAP)|Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 – MAP value at baseline).|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.||mmHg||95% Confidence Interval|Mean
163901|NCT00243347|Primary|Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)|Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value – baseline SUVmax value)/baseline SUVmax value)*100|Randomisation until Day 22|Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.||Percentage change in SUVmax||95% Confidence Interval|Geometric Mean
163902|NCT00243269|Secondary|Health Related Quality of Life|Health-Related Quality of Life was assessed using the Functional Assessment of Cancer Therapy Scale – General (FACT–G). The FACT–G is a 28-item scale developed specifically for use in cancer clinical trials. Possible scores range from a low of 0 to a high of 112. Along with a total score representing HRQL, there are psychometrically validated subscales of physical, functional, social, and cognitive-emotional status. It has become one of the most commonly used measures in oncology, and we have used this scale in our previous studies.|5 days|||Units on scale||Standard Deviation|Mean
163903|NCT00243269|Primary|Five-day Nausea Diary|"Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was assessed on a 7-point rating scale, anchored at one end by 1 = “Not at all nauseated and at the other end by 7 = Extremely nauseated. The description “Moderately nauseated” was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods."|Five days|All patients who did not have protocol violations who provided evaluable data were included in the analyses. No data imputation was used.||Units on scale||Standard Deviation|Mean
163904|NCT00243243|Primary|Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively||24 hours|||units of blood components|||Number
163905|NCT00243191|Primary|To Collect Matched Tumor Tissue of Trial Participants With Dermatofibrosarcoma Protuberans Before and After Treatment With Imatinib for Future Use in cDNA Microarray and Tissue Array Studies.|To obtain matched tumor tissue samples of trial participants dermatofibrosarcoma protuberans (DFSP)for the purpose of determining whether imatinib mesylate affects autocrine/paracrine stimulated signal transduction through the platelet-derived growth factor receptor pathway in DFSP by comparing the level of phosphorylated platelet-derived growth factor receptor beta (PDGFRB) in DFSP after up to 2 weeks of treatment with imatinib to the level of phosphorylated PDGFRB pre-treatment.|Prior to and after 2-weeks of imatinib therapy|Population of paired tissue samples collected from patients with confirmed diagnosis of dermatofibrosarcoma protuberans. Tissue sample will be considered evaluable if there is adequate pre-treatment and on-treatment tumor tissue available for the proposed molecular studies, and resection of DFSP was completed after receiving imatinib.||paired tumor tissue samples|||Number
163906|NCT00243074|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of protocol treatment with AZD2171 (cediranib maleate)||Participants|||Number
163907|NCT00243074|Secondary|Adverse Event Rates|Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment.|Daily during protocol treatment||||||
163908|NCT00243074|Secondary|Objective Response Rate Per Modified RECIST for Pleural Tumors|The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.|Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171||percentage of participants||95% Confidence Interval|Number
163909|NCT00243074|Secondary|Disease Control Rate|The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.|Every 8 weeks until disease progression progression, up to 5 years.|Eligible patients who received AZD2171||percentage of participants||95% Confidence Interval|Number
163910|NCT00243074|Secondary|Progression-free Survival|From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 8 weeks until disease progression or death, up to 5 years.|Eligible patients who received AZD2171||months||95% Confidence Interval|Median
163911|NCT00243074|Secondary|Overall Survival|From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.|Eligible patients who received AZD2171||months||95% Confidence Interval|Median
163912|NCT00243074|Primary|Overall Response Rate|"confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.."|Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Eligible patients who received any amount of AZD2171||percentage of participants||95% Confidence Interval|Number
163913|NCT00243061|Secondary|Change in Vessel Permeability and Blood Flow by DCE-MRI||From baseline to up to 28 days after starting daily oral dosing||||||
163914|NCT00243061|Secondary|Changes in Levels of Soluble Angiogenic Factors||From baseline to up to 6 years||||||
163915|NCT00243061|Secondary|Clinical Benefit Response||Up to 6 years||||||
163916|NCT00243061|Secondary|Time to Disease Progression||Up to 6 years|9 patients developed progressive disease||months||95% Confidence Interval|Median
163923|NCT00243061|Primary|Objective Tumor Response (Partial or Complete Response) According to RECIST|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [J Nat Cancer Inst 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions, assessed by CT or MRI; Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 6 years|Out of 24 patients analyzed, 0 patients had objective response of PR or CR as defined by RECIST||participants|||Number
163924|NCT00243022|Secondary|Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record|The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.|At 2, 4, 6, 12, and 24 months||||||
163925|NCT00243022|Secondary|Overall Survival: Percentage of Patients That Were Alive at 1 Year|Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.|1 year.|All 12 patients followed to death or censored at last visit when known alive||percentage of particpants||95% Confidence Interval|Number
163926|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|1 year|All 12 patients followed to progression or death, or censored at last visit when known alive||percentage of participants||95% Confidence Interval|Number
163927|NCT00243022|Secondary|Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months|Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.|6 months|All 12 patients followed to progression or death, or censored at last visit when known alive||percentage of participants||95% Confidence Interval|Number
163928|NCT00243022|Secondary|Quality of Life at 6 Months|Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)|At 2, 4, 6, 12, and 24 months|At baseline and the most recent post treatment point in time, the QOL data for group 1 consist of n=3 patients and for group 2, n=2. Because of low patient numbers, no analysis was done.|||||
163929|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up – baseline edema.|at 6 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.||cm^3||Standard Deviation|Mean
163930|NCT00243022|Primary|Change From Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up – baseline edema.|at 4 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.||cm^3||Standard Deviation|Mean
163931|NCT00243022|Primary|Change From Pooled Baseline in Peritumoral Brain Edema|The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up – baseline edema|at 2 months|Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used.||cm^3||Standard Deviation|Mean
163932|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24|BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of total hip: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.||percent change||Standard Error|Least Squares Mean
163933|NCT00242710|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 24|MITT population for BMD of lumber spine: all participants who took at least 1 dose of test article, participated in study extension, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 2. Missing values imputed using LOCF method.||percent change||Standard Error|Least Squares Mean
163934|NCT00242710|Secondary|Percentage of Participants With Hyperplasia at Month 24|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 24|EE analysis population for Year 2 included all randomized participants who took at least 1 dose of test article, participated in study extension, had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had biopsy during Month 24, or had hyperplasia diagnosed before Month 24 and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
164526|NCT00230802|Primary|Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation|The proportion of patients in each treatment arm euthyroid through gestation|9 months|proportion of patients in each treatment arm euthyroid through gestation||participants|||Number
163935|NCT00242710|Secondary|Percentage of Participants With Uterine Bleeding or Spotting|Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for uterine bleeding or spotting included all randomized participants who had received at least 1 dose of test article and had at least 1 day of on-therapy bleeding data. Imputation=LOCF. n=participants evaluable for this measure at specified time periods for each arm, respectively.||percentage of participants|||Number
163936|NCT00242710|Secondary|Percentage of Days With Breast Pain|Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.|Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52|MITT population for breast pain: all randomized participants who took at least 1 dose of test article, and had data available at least for 5 of 7 days at screening and 20 days for at least 1 post-baseline interval. n=participants evaluable at specified time periods for each arm, respectively.||percentage of days||Standard Error|Mean
163937|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12|BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.||percent change||Standard Error|Least Squares Mean
163938|NCT00242710|Primary|Bone Mineral Density (BMD) of Total Hip at Screening|BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|MITT population for BMD of total hip included all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1. Missing values were imputed using LOCF method.||g/cm^2||Standard Deviation|Mean
163939|NCT00242710|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12|BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Baseline, Month 12|MITT population for BMD of lumber spine: all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after test article administration was stopped were excluded) at Year 1. Missing values imputed using last observation carried forward (LOCF).||percent change||Standard Error|Least Squares Mean
163940|NCT00242710|Primary|Bone Mineral Density (BMD) of Lumbar Spine at Screening|BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.|Screening|Modified intent-to-treat (MITT) population for BMD of lumber spine included all randomized participants took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1.||grams per square centimeter (g/cm^2)||Standard Deviation|Mean
163941|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Month 12|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Month 12|Efficacy evaluable (EE) analysis population for Year 1: all participants who were randomized and took at least 1 dose of test article, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.||percentage of participants||95% Confidence Interval|Number
163942|NCT00242710|Primary|Percentage of Participants With Hyperplasia at Screening|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.|Screening|Endometrial hyperplasia at screening was an exclusion criterion and participants who had hyperplasia were not included in the analysis. Therefore this data is not available.|||||
163943|NCT00242684|Post-Hoc|Percentage of Subjects With Average Daily Nutrient Intake <90% of Predicted Needs||While hospitalized on TCU, for up to 40 days|||percentage of subjects|||Number
163944|NCT00242684|Primary|Percentage of Subjects With Average Daily Nutrient Intake <70% of Predicted Needs||While hospitalized on TCU, for up to 40 days|||percentage of subjects|||Number
164527|NCT00230282|Secondary|Duration of Response||105 months|||months||Full Range|Median
163945|NCT00242658|Secondary|Change in Behavioral Processes of Change Between Baseline and 6 Months|"Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never."|Baseline and 6 months|||Scores on a Scale||95% Confidence Interval|Mean
163946|NCT00242658|Primary|7-Day Physical Activity Recall (7-Day PAR)|Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months.|6 months|||minutes||95% Confidence Interval|Mean
163947|NCT00242619|Primary|Clinical Global Impression-Severity Scale (CGI-S)|The Clinical Global Impression-Severity Scale (CGI-S) assesses depression severity. It is a 7-point scale, where 1 is the lowest level of depression severity and 7 is the highest level of depression severity.|12 weeks|||units on a scale||Standard Deviation|Mean
163948|NCT00242619|Primary|Hamilton Depression Rating Scale (HDRS-21)|The Hamilton Depression Rating Scale (HDRS-21) measures depression severity on a scale from 0 to 21, with 0 being the lowest level of depression severity and 21 being the highest level of depression severity.|12 weeks|||units on a scale||Standard Deviation|Mean
163949|NCT00242580|Secondary|Mean Change From Baseline in Total Area of Lesion at 12 Months|Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||mm^2||Standard Deviation|Mean
163950|NCT00242580|Secondary|Number of Participants Requiring Verteporfin Treatment Throughout the Study|Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.|Baseline to Month 12|Observed data.||Participants|||Number
163951|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Efficacy variable analyses were performed on the intent-to-treat (ITT) data set. The ITT set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
163952|NCT00242580|Secondary|Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
163953|NCT00242580|Secondary|Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
163954|NCT00242580|Primary|Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.|Baseline to Month 12|Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.||Percentage of Participants|||Number
163955|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|36 Months|The ITT Population consisted of all patients randomized to treatment.||Days||95% Confidence Interval|Median
163956|NCT00242567|Secondary|Skeletal-related Event(SRE)-Free Survival|Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.|36 months|The ITT Population consisted of all patients randomized to treatment.||Days||95% Confidence Interval|Median
163957|NCT00242567|Secondary|Time to Occurrence of Skeletal Related Event or Death|Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.|18 Months|The ITT Population consisted of all patients randomized to treatment.||Days||95% Confidence Interval|Median
163958|NCT00242567|Secondary|Overall Survival at 18 Months and 3 Years|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.|month 18, year 3|The ITT Population will consist of all patients randomized to treatment.||participants|||Number
163959|NCT00242567|Primary|Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer|Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.|18 months|The ITT Population will consist of all patients randomized to treatment.||participants|||Number
163960|NCT00242502|Primary|Progression-free Survival (PFS) Rate|Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to 16 weeks|Six participants were not evaluable.||percentage of participants|||Number
163961|NCT00242385|Secondary|Adverse Events (AEs)|"Investigators assessed severity of AEs (occurring during or after infusions) based on:~MILD: Transient discomfort, does not interfere in a significant manner with participant’s normal functioning level; Resolves spontaneously or may require minimal therapeutic intervention MODERATE: AE produces limited impairment of function, can require therapeutic intervention; AE produces no sequelae; SEVERE: AE results in marked impairment of function, can lead to temporary inability to resume usual life pattern; AE produces sequelae, which require prolonged therapeutic intervention"|Throughout study period (7 months)|Safety Analysis Data Set - all study subjects who had evidence of receiving at least one dose of study medication regardless of any protocol violation.||Events|||Number
163962|NCT00242385|Secondary|Incremental Recovery|Computed from Cmax (mg/ml) divided by dose per kg body weight (mg/kg).|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||(mg/mL) / (mg/kg)||Full Range|Median
163963|NCT00242385|Secondary|Time to Maximum α1-PI Concentration Post-infusion (Tmax)|Time to reach C-max. Tmax is the number of days from infusion to maximum concentration. Samples drawn at the end of infusion are considered to be time zero.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days||Full Range|Median
163964|NCT00242385|Secondary|Maximum Plasma Concentration (Cmax)|Maximum α1-PI concentration following infusion|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||mg/mL||Full Range|Median
163965|NCT00242385|Secondary|Terminal Half-life|Computed from the terminal or disposition rate constant obtained from log_e -linear fitting using the least squares deviation to the last five quantifiable concentrations above pre-infusion level.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days||Full Range|Median
163966|NCT00242385|Secondary|Apparent Volume of Distribution at Steady State|Computed as weight-adjusted CL * MRT|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||mL||Full Range|Median
163967|NCT00242385|Secondary|Mean Residence Time (MRT)|Computed as total area under the moment curve (AUMC) divided by total AUC|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days||Standard Deviation|Mean
163968|NCT00242385|Secondary|Systemic Clearance (CL)|Computed as dose divided by AUC 0-infinity (AUC 0-infinity was calculated as the sum of AUC from time 0 to the time of last quantifiable concentration plus a tail area correction)|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||mL/day||Full Range|Median
163969|NCT00242385|Secondary|Total Area Under the Curve Per Dose|Total area under the α1-PI concentration vs. time curve from pharmacokinetic day 0 to time infinity (AUC 0-infinity) per dose|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|Full Analysis Data Set - all study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days*kg/mL||Full Range|Median
163970|NCT00242385|Primary|Area Under the Curve/Dose|Area under the plasma alpha1-proteinase inhibitor (α1-PI) concentration versus time curve (AUC) calculated by linear trapezoidal method per dose.|Pharmacokinetic evaluation: 30 minutes pre-infusion up to 35 days post-infusion|All study subjects who received at least 1 dose of study product, and provided data suitable for pharmacokinetic analysis||days*kg/mL||Full Range|Median
163971|NCT00242216|Secondary|CD4 Cell Count Change From Baseline During Treatment.||24 weeks.|||cell/mm3||Standard Deviation|Mean
163972|NCT00242216|Primary|Proportion of Patient With Viral Load Less Than 400 Copies/mL||24 weeks|||percentage|||Number
163973|NCT00241839|Secondary|Change in Uric Acid (UA) Levels: Baseline Less End of Treatment|Subjects on allopurinol are expected to lower their uric acid levels relative to placebo.|Baseline UA levels compared to end of treatment levels (8-10 weeks on allopurinol / placebo)|Change in uric acid from baseline to end of treatment.||mg/dl||Standard Deviation|Mean
163974|NCT00241839|Secondary|Change in Overall Mean BP From Those Obtained by 24 Hour Ambulatory Blood Pressure Measurements (ABPM) 8-10 Weeks Minus Baseline.|Subjects had 24 hr blood pressure monitoring (ABPM) at baseline and treatment end. The readings were averaged and the changes from baseline to treatment end were compared.|Baseline and end of treatment (8-10 weeks on allopurinol / placebo)|We obtained over 90% of those with cuff measures on the 24 hour BP measures (ABPM).||mm Hg||Standard Deviation|Mean
163975|NCT00241839|Primary|Change in Systolic Blood Pressure by Cuff After 8-10 Weeks Minus Baseline|"The systolic BP was taken at Baseline and after 8-10 weeks of treatment on placebo, while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.~The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.~Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol or placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).||mm Hg||Standard Deviation|Mean
163976|NCT00241839|Primary|Change in Diastolic Blood Pressure by Cuff 8-10 Weeks Minus Baseline|"The Diastolic BP was taken at Baseline and after 8-10 weeks of treatment or placebo while on chlorthalidone and potassium chloride. The blood pressure was measured according to Shared Care protocol: 15 minutes of quiet, undisturbed rest with three BP measurements obtained subsequently at 5 minute intervals.~The mean of the second and third reading was the value used for analysis for both the Baseline measurement and the measurement after 8 - 10 weeks of treatment. The dependent variable is baseline value minus ending value.~Measures are in millimeters of mercury (mm hg)"|Measured at 8-10 weeks on allopurinol / placebo|Participants were individuals with essential hypertension (BP 140/90-160/100) on none or up 2 antihypertensive drugs without any other chronic condition or illness. For their data to be included in analysis they had to complete the study (includes baseline to last visit).||mm Hg||Standard Deviation|Mean
163977|NCT00241644|Secondary|Number of Seropositive Subjects|Seropositive subjects are defined as subjects with anti-rotavirus IgA antibody concentration ≥ 20 U/mL.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.||subjects|||Number
163978|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies|Geometric mean concentrations are given as Units per milliliter (U/mL).|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity.||U/mL||95% Confidence Interval|Geometric Mean
163979|NCT00241644|Secondary|Number of Seroconverted Subjects|Seroconverted subjects are defined as subjects with appearance of anti-rotavirus IgA antibody concentration ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of vaccine or placebo) seronegative for rotavirus.|One month after the last vaccine or placebo dose|Analysis was performed on the ATP cohort for immunogenicity, only for inititally seronegative subjects.||subjects|||Number
163980|NCT00241644|Secondary|Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects|An initially seronegative subject is a subject whose IgA antibody concentration was below the assay cut-off value of 20 Units per milliliter (U/mL) before administration of the first vaccine dose.|One month after the last vaccine dose|Analysis was performed on the ATP cohort for immunogenicity, only for initially seronegative subjects.||Units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
163981|NCT00241644|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the first dose of vaccine or placebo up to end of the study|||subjects|||Number
163982|NCT00241644|Secondary|Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From the first dose of vaccine or placebo up to end of the study|||subjects|||Number
163983|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.||subjects|||Number
163984|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.||subjects|||Number
163985|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 1 year of age to study end|The analysis was performed on the ATP cohort for efficacy of the second efficacy period.||subjects|||Number
163986|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the ATP cohort for efficacy of the combined efficacy follow-up periods.||subjects|||Number
163987|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 1 year of age to study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the second efficacy period.||subjects|||Number
163988|NCT00241644|Secondary|For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|During the period from 2 weeks after the last dose of vaccine or placebo until study end|The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy of the combined efficacy follow-up periods.||subjects|||Number
163989|NCT00241644|Secondary|Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|RV GE caused by the circulating wild-type rotavirus strain: three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample collected as soon as possible after the symptoms begin.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy||subjects|||Number
163990|NCT00241644|Secondary|Number of Subjects Reporting Severe Gastroenteritis of Any Cause|Number of subjects with gastroenteritis (three or more looser than normal stools or watery stools within a day) that scored ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy.||subjects|||Number
163991|NCT00241644|Secondary|In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the third dose of vaccine or placebo up to 1 year of age|"Analysis was performed on the ATP cohort for efficacy, only for the subset of subjects in South Africa who were fully vaccinated before the beginning of the rotavirus season.~For this analysis, data from Rotarix 2-dose Group and Rotarix 3-dose Group were pooled into one group (Rotarix pooled Group)."||subjects|||Number
163992|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From the first vaccine or placebo dose up to 1 year of age|||subjects|||Number
163993|NCT00241644|Secondary|Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy||subjects|||Number
163994|NCT00241644|Secondary|Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type|"Number of subjects presenting with three or more looser than normal stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.~Rotavirus types were G1 wild type (WT) and non-G1."|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the ATP cohort for efficacy||subjects|||Number
163995|NCT00241644|Primary|Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain|Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.|From 2 weeks after the last vaccine or placebo dose up to 1 year of age|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy||subjects|||Number
163996|NCT00241280|Primary|Rate of Contact Lens Related Serious and Significant Events (SSE)|The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.|Throughout the duration of the study (1 Year)|All subjects that were dispensed a study lens.||percentage of Subjects|||Number
163997|NCT00241280|Primary|Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40|Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.|Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks|The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes.||Percentage of Subjects Eyes|Participants||Number
163998|NCT00241176|Secondary|Clinical Global Impression Severity Scores|The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects)|24 Months|||units on a scale||Standard Deviation|Mean
163999|NCT00241176|Primary|Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)|The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics.|8 Weeks|||units on a scale||Standard Deviation|Mean
164559|NCT00229957|Secondary|Use of Hospital Services|self report use of hospital service|baseline, 15 months||07/2009||||
164000|NCT00240994|Primary|The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation|Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.|Up to one year post kidney transplantation procedure|Intent-to-treat||Proportion of participants|||Number
164001|NCT00240539|Primary|Number of Subjects With Chronic and With Clinical HBV Infection|"Chronic HBV infection: HBsAg+ and anti-HBc+ at more than 2 consecutive time points.~Clinical HBV infection: Serologically confirmed, symptomatic HBV infection, and all HBV markers negative at consecutive time point."|From year 16 through to year 20|||subjects|||Number
164002|NCT00240539|Primary|Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus|Tested markers were hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), hepatitis B envelope antigen (HBeAg) and antibody to hepatitis B envelope antigen (anti-HBe).|At Years 16, 17, 18,19 and 20 after primary vaccination|The analyses were performed on the ATP cohort for immunogenicity. Only subjects positive for HBsAg or anti-HBc markers were tested for HBeAg and anti-HBe markers for Year 17 to Year 20.||subjects|||Number
164003|NCT00240539|Primary|Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies|Seropositive subjects are subjects with anti-HBs antibody concentration ≥ 3.3 mIU/mL.|At Years 16, 17, 18, 19 and 20 after primary vaccination|The analyses were performed on the Long-Term According to protocol (ATP) cohort for immunogenicity. Due to subjects being lost to follow up or eliminated from the ATP cohort for immunogenicity, no data from subjects in HBsAg(+) & HBeAg(-) 4-dose Group and HBsAg(-) & HBeAg(-) 4-dose Group were analyzed.||subjects|||Number
164004|NCT00240526|Primary|Number of Subjects With Different Hepatitis B Infection Statuses|"Categories hepatitis B (HB) infection:~Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples~False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg.~Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples.~Isolated natural booster: >4-fold increase of anti-HBs concentrations if <100 mIU/mL at previous sample OR >2- fold increase of anti-HBs concentrations if >=100 mIU/mL at previous sample + other markers neg"|Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)|Analysis was performed on the Long Term Total Cohort (LT total cohort). The maximum amount of subjects who have participated in any of the time points in this study has been given as number of participants analyzed.||subjects|||Number
164005|NCT00240526|Primary|Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection|Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on the Long Term Total Cohort (LT total cohort) on subjects with available data for the specified marker.||subjects|||Number
164006|NCT00240526|Primary|Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA)|"Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.~Note: Missing CLIA anti-HBs concentrations, for subjects with ELISA results available, are estimated by multiple imputations and GMCs and number of subjects were adjusted for these imputations."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||Subjects|||Number
164007|NCT00240526|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).|Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||subjects|||Number
164008|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).~Note: There was a change of assay kit at Year 19 time-point, thus for the sake of bridging, blood samples corresponding to Year 19 were re-tested with new CLIA. At Year 19 and 20, anti-HBs antibody concentrations tested with the CLIA with cut-off 6.2 mIU/mL."|At Years 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||mIU/mL||95% Confidence Interval|Geometric Mean
164009|NCT00240526|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|"Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).~Note: At Year 15 and 16, a commercial ELISA was used. From Year 17 to Year 20, anti-HBs antibody concentrations were tested with a validated in-house assay with cut-off 3.3mIU/mL."|At Years 15, 16, 17, 18, 19 and 20|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points||mIU/mL||95% Confidence Interval|Geometric Mean
164010|NCT00240500|Primary|Clinical Review for Hepatitis B Infection Status|Chronic hepatitis B (HB) carrier is defined as positive for anti-HBc AND HBsAg at two or more consecutive time points|Over the entire 4 year follow up period (17 - 20 years)|||participants|||Number
164011|NCT00240500|Primary|Prevalence of Serological Markers for Hepatitis B Infection|It was initially planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Only the subjects positive for HBsAg or anti Hepatitis B core antigen (anti-HBc) were tested for HBeAg & anti-HBe|Years 17, 18, 19 and 20.|||Percentage of participants (%)|||Number
164012|NCT00240500|Primary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations|During this follow-up study, it was planned to collect data from Year 16 through to Year 20 after primary vaccination. By the time the study protocol was approved, it was too late to collect data on Year 16. Therefore, the table presents mean concentrations expressed in milli-international units/milliliter (mIU/mL) at years 17, 18, 19 and 20.|Years 17, 18, 19 and 20.|||mIU/mL||95% Confidence Interval|Mean
164560|NCT00229957|Primary|SF-36 Physical Component|health related quality of life. Minimum: 0; Maximum 100.|15 months|||units on a scale||Standard Deviation|Mean
164561|NCT00229723|Secondary|Safety and Tolerability||Assessed over two years||||||
164013|NCT00240487|Primary|Mean PaO2/FiO2 Ratio|Arterial blood gas measurements with cooximetry to evaluate arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio. The mean PaO2/FiO2 ratio for each group after completion 8 hour of study participation was compared|8 hours|||mmHg||Standard Deviation|Mean
164014|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Coronary or Peripheral Revascularisation (Including Above Ankle Limb Amputations).||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
164015|NCT00240331|Secondary|Number of Randomised Participants That Experienced a Procedure as a Result of Stenosis or Thrombosis of the Vascular Access (Arteriovenous (AV) Fistulas and Grafts Only) for Haemodialysis.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
164016|NCT00240331|Secondary|Number of Randomised Participants With an Atherosclerotic Cardiac Event (Non-fatal Myocardial Infarction or Coronary Heart Disease (CHD) Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
164017|NCT00240331|Secondary|Number of Randomised Participants That Died From Non Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years||||||
164018|NCT00240331|Secondary|Number of Randomised Participants That Died From Cardiovascular Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
164019|NCT00240331|Secondary|Number of Randomised Participants With a Major Cardiovascular Event or That Died From Any Known Cause||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
164020|NCT00240331|Secondary|Number of Randomised Participants That Died From Any Cause.||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
164021|NCT00240331|Primary|Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death)||Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years|||Participants|||Number
164022|NCT00240227|Secondary|Change in Urine Drug Analysis Results Between Study Medication and Placebo Periods||4 weeks||||||
164023|NCT00240227|Secondary|Change in Self-reports of Substance Use Between Study Medication and Placebo Periods||4 weeks||||||
164024|NCT00240227|Secondary|Change in Subjective Experience of Craving in Response to Provocative Visual Cues Designed to Elicit Craving, as Measured by the Within Session Rating for Cocaine/Alcohol Craving||During lab session||||||
164025|NCT00240227|Secondary|Change in Blood Pressure Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session||||||
164026|NCT00240227|Secondary|Change in Heart Rate Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session||||||
164027|NCT00240227|Primary|Change in Skin Conductance Response in Response to Provocative Visual Cues Designed to Elicit Craving, Compared to Placebo Group||During lab session|Study was terminated early. No final analyses completed.|||||
164028|NCT00240162|Secondary|Disease Free Survival||Until the patient expires|This secondary outcome was not analyzed.|||||
164029|NCT00240162|Secondary|Safety and Tolerability of PTK787/ZK 222584|Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.|30 days after treatment ends [median of 15 cycles (11-32)]|Only 13 out of the 21 participants experienced a grade 3 or 4 adverse event.||adverse events|||Number
164030|NCT00240162|Secondary|Time to Progression|"Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met.~25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation.~25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation.~35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.~Increase in the size of existing bone lesions or soft tissue plasmacytomas~New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression).~Hypercalcemia - corrected serum calcium > 11.5 mg/dL"|Until the patient progresses or expires (up to 457 days)|Participants were evaluable for time to progression if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.||days||Full Range|Median
164031|NCT00240162|Primary|Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug||Day 90|Participants were evaluable for response if they completed 3 cycles of treatment. 10 out of 21 participants completed 3 cycles of treatment.||participants|||Number
164032|NCT00240110|Secondary|Change From Baseline in Percentage of Money Spent on Cocaine|Change from baseline in percentage of the amount of money spent on cocaine|week 12|All subjects with available data after assignment to study medications||Percentage of Money Spent on Cocaine||Standard Deviation|Mean
164033|NCT00240110|Primary|Change From Baseline in Percentage of Cocaine-abstinent Days|Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)|Week 12|All subjects with available data after assignment to study medications||percentage of days cocaine abstinent||Standard Deviation|Mean
164034|NCT00240097|Primary|Response Rate After Relapse|The objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) – IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|3 weeks after 3rd cycle of starting therapy after relapse or refractory disease|All subjects dropped out or died prior to experiencing relapse|||||
164035|NCT00240097|Secondary|Overall Survival (Part I)|Length of subject survival after starting study treatment|baseline to 2 years|||months||95% Confidence Interval|Median
164036|NCT00240097|Primary|Objective Response Rate (Part I)|The primary objective is to determine the objective tumor response rate of sequential topoisomerase targeting with irinotecan/oxaliplatin followed by etoposide/carboplatin in chemotherapy-naïve patients with extensive SCLC and Stage IIIb (wet) – IV Large Cell Carcinoma of the Lung with neuroendocrine markers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable response means did not meet criteria for progressive or partical response. 20% progressive disease.|baseline to 18 months|||Participants|||Number
164037|NCT00240097|Secondary|Progression Free Survival (Part I)|Time to progressive disease|baseline to five years|||months||95% Confidence Interval|Median
164038|NCT00240071|Secondary|The Secondary Efficacy Outcome Will be Objective Response Rate (Defined as the Rate of Complete and Partial Responses.||Determined on two consecutive occasions at least 4 weeks apart.||||||
164039|NCT00240071|Primary|Progression Free Survival (PFS)|Progression free survival is defined as time from date of randomization until the date of first documented disease progression or date of death from any cause, whichever occurs first.|Every 6 weeks until disease progression|All participants entered onto study (intention to treat) (ITT) were analyzed.||days|Participants|95% Confidence Interval|Median
164040|NCT00239928|Primary|Summary of Adverse Events|Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events|Week 54 (initiation of A5751015 study) up to Week 198|Intent-to-treat||participants|||Number
164041|NCT00239928|Secondary|Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)|Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"||participants|||Number
164042|NCT00239928|Secondary|Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)|Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT 00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"||participants|||Number
164043|NCT00239928|Secondary|Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)|Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat.~Last Observation Carried Forward"||participants|||Number
164044|NCT00239928|Secondary|Number of Responders|Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward"||participants|||Number
164045|NCT00239928|Secondary|Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point|"Value at each observation time point minus value at Week 54 (initiation of current study).~Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Weeks 54, every 18 weeks from Week 54 up to Week 198|"Intent-to-treat, Among 61 subjects, for efficacy analyses, 1 subject had missing data at Week 72.~Last Observation Carried Forward"||letters||Standard Deviation|Mean
164046|NCT00239928|Secondary|Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point|"Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202).~Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0."|Week 0 (baseline), every 18 weeks from Week 54 up to Week 198|"Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat.~Last Observation Carried Forward"||letters||Standard Deviation|Mean
164047|NCT00239837|Secondary|Decision Making|“Cups” task (Weller et al., 2007). On each trial, participants see 2 arrays with equal number of X cups (2, 3, or 5) each. On gain trials, participants informed that under each cup in one array is 1 quarter, and the other array includes 1 cup with Y quarters (either 2, 3, or 5), but the other cups have 0 quarters. Choosing from the riskless side leads to a sure gain of 1 quarter while choosing the risky side can lead to gain of Y quarters or no quarters. On loss trials, participants shown that choosing cup from 1 array will lead to 1 quarter taken away while choosing cup from other array will lead to no quarters or Y quarters taken. Cups task consists of 54 trials of 3 trials each of all combinations of 2 levels of domain (gain, loss). Expected Value Sensitivity (EV) calculated by subtracting proportion of risky choices made when EV actually favored the sure choice from proportion of risky choices made on trials where EV favored risky option. Score can range from -1.0 to -1.0.|Measured at age 15-17|||units on a scale||Standard Deviation|Mean
164048|NCT00239837|Primary|Marijuana Use|The girls were asked how many times in the past year they had used marijuana. The response scale ranged from 1 (never) through 9 (daily). Units on a scale. Log transformed.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||log(units on a scale)||Standard Deviation|Mean
164049|NCT00239837|Primary|Tobacco Use|The girls were asked how many times in the past year they had smoked cigarettes or chewed tobacco. The response scale ranged from 1 (never) through 9 (daily). Units on a scale.|Measured at Month 36|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||log(units on a scale)||Standard Deviation|Mean
168726|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18||Month 18|||L||Standard Error|Mean
164050|NCT00239837|Secondary|Placement Changes|Child welfare system records were collected at each assessment to determine the girls’ placement changes (including the number and type of changes). Placement changes since the start of the study through 12 months were summed for each girl. The number of placement changes ranged from 0 to 7 during this period. Units on a scale. Higher scores indicate more placement changes.|Measured at Months 6 and 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||placement changes||Standard Deviation|Mean
164051|NCT00239837|Secondary|Social Competence|Prosocial behavior was measured with a subscale from the Parent Daily Report (PDR; Chamberlain & Reid, 1987). The PDR was administered individually by telephone to foster parents on 3 consecutive or closely spaced days (1–3 days apart) at each assessment. A trained interviewer asked the foster parent whether a list of prosocial behaviors took place during the previous 24 hr (yes/no format). The prosocial scale was computed based on nine items, such as “cleans up after herself” and “do a favor for someone.” The PDR was designed to avoid the potential bias of aggregate recall of frequency estimates. Studies have reported concurrent and predictive validity of the PDR checklist. The scores were averaged (mean) across calls from 3 days. Scores on prosocial behavior at 6 and 12 months were averaged and the mean across both time points was used in analysis. Units on a scale. Range = 0-9. Higher scores indicate more prosocial behavior.|Measured at Months 6, 12|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||units on a scale||Standard Deviation|Mean
164052|NCT00239837|Secondary|Participation in Risky Sexual Behaviors|Eight items from the girls’ in-person interviews were used to assess health risking sexual behavior at the 36-month followup. The girls reported on items such as touching a boy’s body above or below the waist, having sexual intercourse, having sex with someone who they just met, or having sex with someone using drugs in the past 12 months. Positive answers to these items were totaled to represent the cumulative number of health-risking sexual behaviors. The frequency of the cumulative number of risky sexual acts ranged from 0 to 7. Units on a scale. Higher scores indicate more health-risking sexual behaviors.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present||units on a scale||Standard Deviation|Mean
164053|NCT00239837|Secondary|Mental Health Problems|Internalizing and externalizing symptoms at 12 and 24 months were measured with caregiver report on the Achenbach System of Empirically Based Assessment (ASEBA). This widely used checklist for psychopathological behaviors includes scales for behaviors such as Anxious/Depressed; Withdrawn; Somatic Complaints; Thought Problems; Attention Problems; Aggressive Behavior; Rule-Breaking Behavior; and Intrusive. The ASEBA has been shown to have both construct and content validity in the literature. For the present study, raw scores for the internalizing and externalizing symptoms subscales were used. Scores at 12 and 24 months were combined and averaged (mean). Units on a scale. Range = 0-66. Higher scores indicate higher levels of internalizing or externalizing problems.|Measured at Months 12 and 24|Full information maximum likelihood (FIML) analysis includes estimation of all cases even when missing data are present||units on a scale||Standard Deviation|Mean
164054|NCT00239837|Primary|Delinquency|36 items from the general delinquency scale from the Self-Report Delinquency Scale (SRD; Elliott, Huizinga, & Ageton, 1985). Units on a scale. Girls were asked to rate how many times they had committed various delinquent acts (e.g., damaging or destroying properties, and stealing) in the past year, using an open-ended format. The mean of frequencies across these items was used to represent the level of delinquency for girls. The general delinquency scale scores ranged from 0 to 24 (full scale) and from 0 to 13 (log transformed). Higher scores indicate higher levels of delinquency.|Measured at Month 36|FIML analysis includes estimation of all cases even when missing data are present||log(units on a scale)||Standard Deviation|Mean
164055|NCT00239720|Primary|Proportion of Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months|"Participants who improve by at least 1 unit from baseline in either the physician or participant global assessment and have at least 30% improvement from baseline in either tender or swollen joint scores[1] at 6 months from start of treatment and received at least 2 cycles of treatment~The tender and swollen joint scores assess 68 and 66 joints, respectively, with each joint rated from 0 to 3. Total scores range from 0-204 for tenderness and 0-198 for swelling, with higher scores indicating more severe symptoms[2].~Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20."|6 Months|Intent-to-treat||Participants|||Number
164056|NCT00239681|Secondary|Time to Bone Fracture|Days from randomization until bone fracture. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|Up to 5 years|Intention to treat population||Days||Standard Error|Mean
164057|NCT00239681|Secondary|Time to Venous Thromboembolic Event|Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
164058|NCT00239681|Secondary|Time to Development of Diabetes Mellitus|Days from randomization until development of diabetes. If no diabetes was developed censoring occurred at termination date. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
164059|NCT00239681|Secondary|Time to Non-cardiovascular Death|Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
164060|NCT00239681|Secondary|Time to Death Due to Any Cause|Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 30 Mar 2008. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||days||Standard Error|Mean
164061|NCT00239681|Primary|Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization)|Days from randomization to the first of CV death, stroke, MI, hospitalization for unstable angina or arterial revascularization. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 30 Mar 2008. Events were adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean|up to 5 years|Intention to treat population||Days||Standard Error|Mean
164062|NCT00239642|Secondary|Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
164063|NCT00239642|Secondary|Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline|Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline|anytime during the 12 week post-baseline period|mITT subjects||participants|||Number
164064|NCT00239642|Secondary|Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive|Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
164065|NCT00239642|Secondary|Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive|Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive|anytime during the 12 week post-baseline period|mITT subjects||participants|||Number
164066|NCT00239642|Secondary|Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
164067|NCT00239642|Secondary|Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive|Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive|anytime during the 12-week post-baseline period|mITT subjects||participants|||Number
164068|NCT00239642|Secondary|Percentage (%) of Subjects Achieving Clinical Success|Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects||percentage of subjects|||Number
164069|NCT00239642|Secondary|Number of Subjects Achieving Clinical Success|Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)|anytime during the 12 week post-baseline period|mITT subjects||participants|||Number
164070|NCT00239642|Primary|Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event|Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm|baseline through week 12|Safety Population - Subjects who received at least 1 dose of study drug.||participants|||Number
164071|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant ECG Abnormalities During Treatment - Safety Population|Potentially clinically relevant abnormality or change relative to baseline: sinus tachycardia: >= 120 beats per minute (bpm) and increased >= 15 bpm; sinus bradycardia: <= 50 bpm and decrease >= 15 bpm; supraventricular tachycardia, ventricular tachycardia, atrial fibrillation, atrial flutter: not present to present. First degree atrioventricular (A-V) block: PR interval(beginner of P wave to beginning of complex of Q, R, and S waves) >= 0.20 seconds (sec) and increase >= 0.05 sec; second and third degree A-V block, right bundle branch block (RBB) block, left bundle branch block (LBB) block: not present to present; other intraventricular block: QRS (complex of Q, R and S waves) >= 0.12 sec and increase >= 0.02 sec. Myocardial ischemia not present to present. QT interval with Bazett's correction (QTcB) or Fridericia's correction (QTcF) >= 450 milliseconds (msec) and elevation of 10% over baseline.|Baseline to end of study (Week 348|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each ECG parameter and includes those treated participants with ECG measurements.||participants|||Number
164072|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Vital Sign Abnormality During Treatment - Safety Population|Vital signs include standing, sitting and supine systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg) and standing, sitting and supine heart rate, measured in beats per minute. Baseline (BL) is Day 1 of the study, prior to study drug administration. Criteria for identifying vital sign values as clinically relevant: Systolic blood pressure (criterion value=90-180 mmHg) change relative to baseline: increase of greater than, equal to (>=) 20; decrease of >= 20 mmHg. Diastolic blood pressure (criterion value=50 - 105 mmHg) change relative to baseline: increase of >= 15; decrease of >= 15 mmHg. Heart rate (criterion value=50-120bpm) change relative to baseline: increase >=15; decreased >= 15 mmHg. To be clinically significantly abnormal: value must meet the criterion value and also represent a change from the participant's pre-treatment value of at least the magnitude shown in the change relative to baseline.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participants analyzed is given as N in each vital sign parameter and includes those treated participants with vital sign measurements.||participants|||Number
164073|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Hematology Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant laboratory abnormality: Hemoglobin male <= 11.5 g/dL; female <= 9.5 g/dL. Hematocrit male <= 37 and 3 point decrease from baseline (BL); female <=32 and 3 point decrease from BL. Leukocytes <= 2800 mm^3 or >= 16000 mm^3; eosinophils >=10%. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.||participants|||Number
164074|NCT00239356|Secondary|Number of Participants With Potentially Clinically Relevant Chemistry Laboratory Abnormalities During Treatment - Safety Population|Clinically relevant abnormalities: greater than, equal to (>=); less than, equal to (<=). Upper limits of normal (ULN). milligram per deciliter (mg/dL); milliequivalent per liter (mEq/L); nanograms per milliliter (ng/mL);outside of normal range inclusive (): alanine transaminase (ALT>= 3*ULN; aspartate aminotransferase (AST >=3*ULN; alkaline phosphatase >=3*ULN; total bilirubin >= 2.0 mg/dL; blood urea nitrogen >= 30mg/dL; calcium (8.40 - 9.90 mg/dL); chloride (85.00 - 108.00 mEq/L); total cholesterol (140.0 - 200.0 mg/dL); cholesterol high density (HDL) and low density (LDL) lipoprotein (39.0 - 116.0 mg/dL); creatine kinase (15.0 - 170.0 U/L); creatinine >=2.0 mg/dL; prolactin (3.00 - 29.00 ng/mL); sodium (136.0 - 144.0 mEq/L); Glucose fasting (70.0 - 110.0 mg/dL); triglycerides (58.0 - 164.0 mg/dL; uric acid male >= 10.5, female >= 8.5mg/dL. Baseline is Day 1 of the study, prior to study drug administration.|Baseline to end of study (Week 348)|Safety Population: all participants with at least 1 dose of study drug. Number of participant analyzed is given as N in each category of laboratory test.||participants|||Number
164075|NCT00239356|Secondary|Mean Exposure to Aripiprazole at Days 541 to 630, Days 721 to 810 and Days 1081 to 1170 - Safety Population|Mean exposure is mean number of milligrams per day (mg/day) of aripiprazole administered to the participants.|Day 1 to Day 1170|N=number of participants receiving drug at Days indicated.||mg/day||Full Range|Mean
164076|NCT00239356|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to an AE - Safety Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Baseline to Week 348|Safety Population: all participants with at least 1 dose of study drug.||participants|||Number
164077|NCT00239356|Primary|Mean Clinical Global Impression Severity Score (CGI-S) From Baseline Through End of Study- - Safety Population.|Baseline is Day 1 of the study, prior to first dose. CGI-S is a questionnaire completed by the clinician which evaluates the severity of mental illness of a participant at a specific point in time. It consists of 7 categories with the lower categories indicating less illness and the higher numbered categories indicating greater severity of illness: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3= mildly ill; 4=moderately ill; 5= markedly ill; 6=severely ill; 7=among the most extremely ill.|Baseline to Week 348|Safety Population - all participants who received at least one dose of drug. N=number of participants who were analyzed at each specific time point. Baseline N=97, 20 for first and second arms, respectively.||units on a scale||Standard Deviation|Mean
164078|NCT00239226|Secondary|Ventricular Pacing Percentage||January 2009||||||
164079|NCT00239226|Secondary|AF Burden||January 2009||||||
164080|NCT00239226|Secondary|Number of Episodes/Day||January 2009||||||
164081|NCT00239226|Secondary|Time to First Persistent Episode of Atrial Fibrillation (AF)||January 2009||||||
164082|NCT00239226|Secondary|Heart Failure: Comparison Between All Groups||January 2009||||||
164083|NCT00239226|Secondary|Number of Cardioversion: Comparison Between All Groups||January 2009||||||
164084|NCT00239226|Secondary|Symptom Scale Questionnaire: Comparison Between All Groups||January 2009||||||
164085|NCT00239226|Secondary|Number of Patients With Permanent Atrial Fibrillation (AF)||January 2009||||||
164086|NCT00239226|Secondary|Number of Persistent Atrial Fibrillation (AF) Episodes: Comparison Between All Groups||January 2009||||||
164087|NCT00239226|Primary|Number of Patients With Persistent Atrial Fibrillation (AF) After a Mean Follow-up of 15±7 Months: Comparison Between IAS and RAA Pacing in the Study Group|Persistent Atrial Fibrillation (AF) incidence|1 year|97 pts completed the study after a mean fu period of 15±7 months.||Number of patients with persistent AF|||Number
164088|NCT00239005|Secondary|Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).|Health-related quality of life (HRQoL)was assessed by the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI also has five different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) producing a total score of the 36 items. Lower scores represent more dysfunction. A higher score represents a better quality of life (range from 0 to 144).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GIQLI questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.||Units on a scale||Standard Error|Least Squares Mean
164089|NCT00239005|Secondary|Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).|The GSRS is a 15-item instrument designed to assess the impact of upper and lower GI symptoms. There are five subscales: reflux, diarrhea, constipation, abdominal pain, and indigestion—each of which produces a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). A higher score represents greater impairment of quality of life due to GI symptoms (range from 1 to 7).|At week 3 and week 13 (last visit)|Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GSRS questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.||Units on a scale||Standard Error|Least Squares Mean
164090|NCT00239005|Primary|Mycophenolic Acid (MPA) Maintenance Treatment|The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.|at week 13 (last visit)|The intent-to-treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable.||Percentage of Patients||95% Confidence Interval|Number
164091|NCT00238615|Primary|2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.|Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.|Two years|All patients alive and not censored at 2 years||participants|||Number
164092|NCT00238615|Other Pre-specified|Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen|This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.|Specimen collected at time of surgery|Plan was to analyze all patients with adequate tissue for this analysis, but was not done. We did not have sufficient funds for this analysis.|||||
164106|NCT00238238|Primary|Time to Progression|Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.||years||95% Confidence Interval|Median
164151|NCT00237458|Primary|Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||participants|||Number
164093|NCT00238615|Secondary|Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival|The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.|baseline, 5 weeks after combined chemo-radiation|All enrolled patients were analyzed in the published manuscript||standardized uptake value (SUV)max||Standard Deviation|Mean
164094|NCT00238420|Secondary|Five-year Overall Survival|Calculated using the Kaplan-Meier method.|From the date of treatment started to the date of the failure event, assessed up to at least 5 years||||||
164095|NCT00238420|Secondary|Five-year Disease-free Survival|Calculated using the Kaplan-Meier method.|From the date of treatment started to the date of documentation of progression or until the date of death, assessed up to at least 5 years||||||
164096|NCT00238420|Secondary|Complete Response to Treatment|The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment.|At 12 weeks from treatment start|All eligible patients who started treatment and had an evaluation to assess response by 12 weeks||percentage of participants||95% Confidence Interval|Number
164097|NCT00238420|Secondary|Treatment Completion|The number of patients within each group who completed all elements of protocol treatment are reported.|From registration to end of treatment; up to 64 days.”|All eligible patients who started study treatment||participants|||Number
164098|NCT00238420|Primary|Acute Treatment-related Toxicity|In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: ≥ gr4 neutropenia, ≥ gr4 febrile neutropenia, ≥ gr3 diarrhea, ≥ gr3 nausea/vomiting, ≥ gr3 thrombocytopenia, ≥ gr3 renal, pulmonary, hepatic, or neurologic toxicity, ≥ gr3 rectal or genitourinary bleeding, ≥ gr3 left ventricular failure, or ≥ gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis.|From start of protocol treatment to 90 days|All eligible patients who started study treatment||participants|||Number
164099|NCT00238355|Secondary|Safety||duration of study||||||
164100|NCT00238355|Secondary|Duration of Survival up to 12 Weeks||up to 12 weeks||||||
164101|NCT00238355|Primary|Number of Participants With a Complete or Partial Response Rate to the Combination of Voriconazole and Caspofungin at 12 Weeks.|Patients will be followed through day 84 (12 weeks), regardless of continuation of study drugs. Complete response: Resolution of all clinical signs and symptoms and more than 90 percent of the lesions due to invasive fungus that were visible by radiology. Partial response: Clinical improvement and greater than 50 percent improvement in the lesions due to invasive fungus that were visible by radiology.|12 weeks after starting treatment|||Participants|||Number
164102|NCT00238303|Secondary|Time to Progression|"Estimated using Kaplan-Meier survival curve.~Definition of progression:~Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|From registration to disease progression (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was progression-free at last follow-up.||months||Full Range|Median
164103|NCT00238303|Secondary|Confirmed Tumor Response|"A confirmed tumor response will be defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations, which include neuroimaging, lasting during a period of at least 6 weeks. Confidence intervals for the true proportion will be calculated using the exact binomial method.~Bidimensionally measurable disease:≥50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Assessed up to 5 years|"Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.~Stratum 2: Since the patients underwent surgery, response is not applicable and hence 0 patients analyzed."||percentage of participants||95% Confidence Interval|Number
164104|NCT00238303|Secondary|Survival|Estimated using Kaplan-Meier survival curve.|From study registration to date of death due to any cause or last follow-up (up to 5 years)|Stratum 1: 68 patients were enrolled. 2 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed. The patient that survived 28 months was alive at last follow-up.||months||Full Range|Median
164105|NCT00238303|Primary|Proportion of Successes (Patients Alive and Progression-free)|"Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 95% confidence interval estimated by the exact method.~Definition of progression:~Bidimensionally measurable disease: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.~Evaluable disease (i.e., contrast enhancing mass on MRI and/or CT that is not bidimensionally measurable but clearly evaluable for response to therapy): unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions."|At 6 months|68 Stratum 1 patients were enrolled. 2 stratum 1 patients did not receive treatment. Therefore, the remaining 66 patients were analyzed.||percentage of participants||95% Confidence Interval|Number
164107|NCT00238238|Primary|Overall Response Rate|Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.|Duration of treatment (12 cycles)|Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.||percentage of participants||95% Confidence Interval|Number
164108|NCT00238121|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the RECIST: Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; progressive disease(PD), at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years|||Month||Full Range|Mean
164109|NCT00238121|Secondary|Progression Free Survival|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to RECIST, progressive disease(PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions.|Up to 5 years|||Month||95% Confidence Interval|Median
164110|NCT00238121|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|Up to 5 years|||Month||95% Confidence Interval|Median
164111|NCT00238121|Primary|Objective Overall Response Rate|Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.|Up to 5 years|||participants|||Number
164112|NCT00238108|Secondary|Change in Blood Pressure||measured before, during, and after each inpatient phase||||||
164113|NCT00238108|Primary|Sleep Quality|Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)|Measurement after 3 weeks of supplementation|One subject was removed from analysis because of an unstable dose of prescription medication.||% (% asleep during 8 hour opportunity)||Standard Error|Mean
164114|NCT00237796|Secondary|Beck Anxiety Inventory (BAI)|The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions. Scores from individual items are summed to yield a total score. The total score ranges from 0-63. Higher scores represent greater severity of anxiety.|baseline, mid-treatment, end of treatment, mid follow-up, and follow up|||units on a scale||Standard Deviation|Mean
164115|NCT00237796|Secondary|Beck Depression Inventory-II (BDI-II)|The BDI-II is a self-report measure of depression that consists of 21 questions. The total scale ranges from 0-63. Scores from individual questions are summed to yield a total score. Higher scores represent greater severity of depression.|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up|||units on a scale||Standard Deviation|Mean
164116|NCT00237796|Secondary|The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).|baseline, mid-treatment, end of treatment, mid follow-up, and follow-up|||units on a scale||Standard Deviation|Mean
164117|NCT00237796|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression|The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).|baseline, mid treatment, end of treatment, mid follow-up, and follow up|||units on a scale||Standard Deviation|Mean
164118|NCT00237796|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility. Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.|baseline, mid-treatment, end of treatment, mid follow-up, and followup|||units on a scale||Standard Deviation|Mean
164119|NCT00237796|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up|||units on a scale||Standard Deviation|Mean
164120|NCT00237796|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.|baseline, mid-treatment, end of treatment, mid-follow up, and follow up|||units on a scale||Standard Deviation|Mean
164121|NCT00237770|Primary|Systolic Blood Pressure During Head-up Tilt|Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.|Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo.|||mmHg||Standard Deviation|Mean
164150|NCT00237458|Primary|Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.||From Baseline Visit to Final Week of Treatment (approximately 10 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||participants|||Number
164122|NCT00237744|Primary|M1 Activation Absolute Change Score|A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659.|at baseline and following 3 months of treatment|This is a sub sample of subjects eligible to undergo fMRI testing. A total of 23 subjects were eligible (5 subjects in the wrist/hand FES+ whole arm motor learning group; 8 subjects in the shoulder/elbow robotics+whole arm motor learning group and 10 subjects in the Whole arm motor learning group).||voxels||Standard Deviation|Mean
164123|NCT00237744|Primary|AMAT|The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test.|prior to treatment and following 3 months of treatment|||seconds||Standard Deviation|Mean
164124|NCT00237718|Secondary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.||pg/ml||Standard Deviation|Mean
164125|NCT00237718|Primary|F2-isoprostane (F2-iso)|F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.|month 6|The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.||ng/ml||Standard Deviation|Mean
164126|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at 12 month.~BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|12-month|||mmHg||Standard Deviation|Mean
164127|NCT00237692|Primary|Blood Pressure Averages Systolic & Diastolic|"Blood pressure measured at Baseline.~BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model."|Baseline|||mmHg||Standard Deviation|Mean
164128|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 18 Months|When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|18 month|||% of particpants with controlled SBP|||Number
164129|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 12 Months|When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|12 month|||% of particpants with controlled SBP|||Number
164130|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at 6 Months|When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|6month|||% of particpants with controlled SBP|||Number
164131|NCT00237692|Primary|Estimated Percentage of Participants in Blood Pressure Control at Baseline|When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients|Baseline|||% of particpants w/ controlled BP|||Number
164132|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)|Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
164133|NCT00237666|Secondary|Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
164134|NCT00237666|Secondary|Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint|Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Score on a scale||Standard Deviation|Mean
164135|NCT00237666|Secondary|Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2|"Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.~18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial."|Week 8|||percentage of subjects with CGI-I </=2||95% Confidence Interval|Number
164136|NCT00237666|Secondary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale|Montgomery–Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
165204|NCT00209339|Secondary|Other Secondary Safety Events|Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major).|Through 30 days|||percentage of participants|||Number
164137|NCT00237666|Secondary|Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)|Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
164138|NCT00237666|Primary|The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores|Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.|Week 8|Per protocol, the number of participants for analysis was 30 randomized subjects; data analyzed at Week 8 or Last Observation Carried Forward for the 6 subjects who dropped out before completion.||Scores on a scale||Standard Deviation|Mean
164139|NCT00237458|Secondary|"Percentage of Days With Concomitant Pain (Rescue) Medications Taken During Titration and Treatment Phases."|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|From Titration Phase through Treatment Phase (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 5 are included in this analysis.||percentage of days||Standard Deviation|Mean
164140|NCT00237458|Secondary|Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Titration Phase.|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|Titration Period (approximately 6 weeks)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.||percentage of days||Standard Deviation|Mean
164141|NCT00237458|Secondary|Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Baseline Phase.|"The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).~The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.~Summary statistics include mean and standard deviation."|Baseline Period (approximately 1 week)|Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.||percentage of days||Standard Deviation|Mean
164142|NCT00237458|Secondary|Investigator's Global Impression of Change In Pain During The Treatment Period.|"The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:~Much better~Moderately better~Mildly better~No change~Mildly worse~Moderately worse~Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||percentage of participants|||Number
164143|NCT00237458|Secondary|Subject's Global Impression of Change In Pain During The Treatment Period.|"The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:~Much better~Moderately better~Mildly better~No change~Mildly worse~Moderately worse~Much worse"|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||percentage of participants|||Number
164144|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.|"Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).~Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful."|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
164145|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
164146|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
164147|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
164148|NCT00237458|Secondary|Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.|Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
164149|NCT00237458|Secondary|Within-Subject Change In Average Daily Pain Score During the Treatment Period.|The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).|From Baseline Visit to Final Week of Treatment (approximately 9 years)|Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.||units on a scale||Standard Deviation|Mean
164152|NCT00237185|Secondary|Time to Progression (Core + Extension)|Time to progression was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of progression or death due to disease indication or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
164153|NCT00237185|Secondary|Time to Onset of Response (Core + Extension)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
164154|NCT00237185|Secondary|Time to Onset of Response (Core)|Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment.|Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||weeks||95% Confidence Interval|Median
164155|NCT00237185|Secondary|Time to Treatment Failure (Core + Extension)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||months||95% Confidence Interval|Median
164156|NCT00237185|Secondary|Time to Treatment Failure (Core)|Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis ate the time of their last tumor assessment.|Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months.|Treatment population: the treatment population included all participants who received at least one dose of study medication.||weeks||95% Confidence Interval|Median
164157|NCT00237185|Secondary|Progression Free Survival (PFS) (Core + Extension)|Progression free survival was analyzed as a time to event for each participant. If a participant had no event, then the PFS was censored at the last tumor assessment.|Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.||months||95% Confidence Interval|Median
164158|NCT00237185|Secondary|Duration of Response (Core + Extension)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.||months||95% Confidence Interval|Median
164159|NCT00237185|Secondary|Duration of Response (Core)|Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD.|Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR.||weeks||95% Confidence Interval|Median
164160|NCT00237185|Secondary|Overall Survival (Core + Extension)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.||months||95% Confidence Interval|Median
164161|NCT00237185|Secondary|Overall Survival (Core)|Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact.|Date of first imatinib dose to the date of death during the core period, up to 36 months.|Treatment population: the treatment population included all participants who had at least one dose of study medication.||months||95% Confidence Interval|Median
164179|NCT00236938|Primary|Mean Change From Baseline to the Highest Hemoglobin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement.||g/dL||Standard Deviation|Mean
164180|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.||participants|||Number
164162|NCT00237185|Primary|Best Tumor Response (Core + Extension)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 156|Treatment population: the treatment population included all participants who had at least one dose of study medication.||participants|||Number
164163|NCT00237185|Primary|Best Tumor Response (Core)|Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response.|Month 36|Treatment population: The treatment population included all randomized participants who received at least one dose of study medication.||participants|||Number
164164|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|12 months|Participants with 12 month follow up data. Intention to treat analysis.||participants|||Number
164165|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|12 months|Participants with 12 month follow up data. Intention to treat analysis.||Units on a scale||Standard Deviation|Mean
164166|NCT00237042|Secondary|Number of Participants With Pain-Related Activity Interference|Degree to which pain interferes with: daily activities, work and household activities, recreational activities (mean of 3 0-10 ratings); dichotomized as presence/absence of pain-related activity interference|6 Months|Participants with 6 month follow up data. Intention to treat analysis.||participants|||Number
164167|NCT00237042|Primary|Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)|Average of 0-10 ratings of current facial pain, average facial pain in the last month and worst facial pain in the last month, where 0 is no pain and 10 is pain as bad as could be. For the combined outcome, the minimum score is 0 and maximum is 10, with 0 being better (no pain) and 10 being the worst outcome.|6 months|Participants with 6 month follow up data. Intention to treat analysis.||units on a scale||Standard Deviation|Mean
164168|NCT00236977|Secondary|Mean Change From Baseline in Hemoglobin (g/dL) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||g/dL||Standard Deviation|Mean
164169|NCT00236977|Secondary|Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56||Change from Baseline at Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||percentage of change||Standard Deviation|Mean
164170|NCT00236977|Secondary|Mean Change in Ferritin (ng/mL) From Baseline to Day 56||Change from Baseline at Day 56|||ng/mL||Standard Deviation|Mean
164171|NCT00236977|Secondary|Highest Change From Baseline in Ferritin (ng/mL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.||ng/mL||Standard Deviation|Mean
164172|NCT00236977|Secondary|Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56||Change from Baseline up to Day 56|Only subjects who completed the study from the Intent to Treat (ITT) population.||g/dL||Standard Deviation|Mean
164173|NCT00236977|Secondary|Number of Subjects With a Clinical Response|Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml)|Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||participants|||Number
164174|NCT00236977|Primary|Patients With an Increase in Hemoglobin >= 1gm/dL.||Change from Baseline up to Day 56|Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.||participants|||Number
164175|NCT00236951|Primary|Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).|The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).|During Stage 2 (week 9 through week 21)|intention to treat (ITT)||g/dL||Standard Deviation|Mean
164176|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)||percentage of change||Standard Deviation|Mean
164177|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Ferritin up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)||ng/mL||Standard Deviation|Mean
164178|NCT00236938|Secondary|The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71||Change from Baseline up to Day 71|Intent-to-Treat Population (ITT)||percentage of change||Standard Deviation|Mean
168727|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12|||L||Standard Error|Mean
164181|NCT00236899|Secondary|Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle|RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as all randomized participants.||participants|||Number
164182|NCT00236899|Secondary|Number of Participants With Serious and Nonserious Adverse Events (AEs)|Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.|Baseline up to 51.64 months|Intent to treat (ITT) population defined as the population of all randomized participants.||participants|||Number
164183|NCT00236899|Secondary|Overall Response Rate(ORR) by Treatment Drug|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized participants treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population.||percentage of responses|||Number
164184|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Drug|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.||months||95% Confidence Interval|Median
164185|NCT00236899|Secondary|Overall Response Rate (ORR) by Treatment Schedule|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response≥30% decrease in sum of longest diameter of target lesions; Progressive Disease≥20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.|Baseline up to 49.84 months|All randomized patients treated with at least 1 dose of Docetaxel, Paclitaxel or Gemcitabine. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population.||percentage of responses|||Number
164186|NCT00236899|Secondary|Overall Survival (OS) by Treatment Drug|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 109 participants were censored with 55 (46.61%) in the Docetaxel+Gemcitabine arm and 54 (43.90%) in the Paclitaxel+Gemcitabine arm.||months||95% Confidence Interval|Median
164187|NCT00236899|Secondary|Overall Survival (OS) by Treatment Schedule|OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).|Baseline up to 51.64 months|Intention to treat (ITT) population defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 109 (45.2%) participants were censored with 53 (45.3%) in the Weekly arm and 56 (45.2%) participants in the 3 Weekly arm.||months||95% Confidence Interval|Mean
164188|NCT00236899|Primary|Time to Progressive Disease (TTPD) by Treatment Schedule|"TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions."|Baseline up to 49.84 months|Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.||months||95% Confidence Interval|Median
164189|NCT00236197|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period||||||
164190|NCT00236197|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole||14 day randomized treatment period||||||
164191|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Nighttimes||14-day randomized treatment period||||||
164192|NCT00236197|Secondary|Summary of Percentage of Heartburn-Free Daytimes|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
164263|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)|Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164193|NCT00236197|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population|The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.|First 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.||Participants|||Number
164194|NCT00236184|Primary|Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.|"Subject was considered complete relief if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity."|first 24 hours|The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.||participants|||Number
164195|NCT00236184|Secondary|Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
164196|NCT00236184|Secondary|Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
164197|NCT00236184|Secondary|Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
164198|NCT00236184|Secondary|Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population|comparison between placebo and treatment will be analyzed using two-sample t-test.|14-day treatment period.||||||
164199|NCT00236080|Primary|Psychomotor Vigilance Task (PVT)|The computer-based PVT took 10 minutes to complete and measured reaction time stimulus in milliseconds. The reaction time consisted of the digits 000 initially appearing in a window on the PVT device, after which the 3-digit numbers increased in milliseconds until the response button was pressed by the patient. The resulting number at the button press was the reaction time in milliseconds. There was a variable 1- to 10-second interstimulus interval. After pressing the button in response to each stimulus, the button was released and the patient awaited the next stimulus.|Endpoint (Visit 4) change from baseline (Visit 2)|Of the patients who completed the study, 1 patient in the PROVIGIL 200 mg/day treatment group and 1 patient in the Armodafinil 150 mg/day treatment group did not complete their PVT assessment.||Milliseconds||Standard Deviation|Mean
164200|NCT00236080|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the likelihood of falling asleep. Five 20-minute (maximum) MSLT naps were performed (at 2300, 0100, 0300, 0500, and 0700) at both the screening/baseline assessment visit (Visit 2) and at endpoint (Visit 4). Each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights out to the first epoch scored as sleep.|Endpoint (Visit 4) change from baseline (Visit 2)|"1 Placebo Patient did not have an MSLT but did complete the other Primary Measure (PVT) and other requirements. This patient was termed a Completer.~1 Patient in the Armodafinil 200 mg/day group had an MSLT performed but then discontinued the study drug before reaching the study endpoint and was termed a Non-Completer for the Study."||Minutes||Standard Deviation|Mean
164201|NCT00235989|Secondary|Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b|Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).|At End of Study Visit (week 234)|For the NAb analyses data were provided for 40 patients instead of 61 for week 234. Twenty-one patients had no data at this visit.The entries in the table are the number of patients with positive titer in the extension treatment cohorts for the three cutoff titer values. The analyses provide frequencies of positive titers.||participants|||Number
164202|NCT00235989|Primary|Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities|Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.|At End of Study Visit (week 234)|The statistical analysis was descriptive. For Liver Function Toxicity grading, the total number of patients for 250 micrograms (mcg) - 500 mcg group was 19 instead of 20 for all analyses.||participants|||Number
164203|NCT00235872|Secondary|Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit|Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||IU/mL||Standard Deviation|Mean
164204|NCT00235872|Secondary|Presence of Rheumatoid Factor (RF)|The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||participants|||Number
168728|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12||Month 12|||L||Standard Error|Mean
164205|NCT00235872|Secondary|Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit|Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||minutes||Standard Deviation|Mean
164206|NCT00235872|Secondary|Presence of Morning Stiffness|The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||participants|||Number
164207|NCT00235872|Secondary|Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mg/dL||Standard Deviation|Mean
164208|NCT00235872|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit|Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on a scale||Standard Deviation|Mean
164209|NCT00235872|Secondary|Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on unit scale||Standard Deviation|Mean
164210|NCT00235872|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit|Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on unit scale||Standard Deviation|Mean
164211|NCT00235872|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit|Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||mm on a scale||Standard Deviation|Mean
164212|NCT00235872|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||SJC||Standard Deviation|Mean
165519|NCT00203424|Primary|Time to Tumor Recurrence||Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment|||days||Full Range|Mean
164213|NCT00235872|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit|Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||TJC||Standard Deviation|Mean
164214|NCT00235872|Primary|Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)|Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.|Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)|Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.||participants|||Number
164215|NCT00235833|Secondary|Number of Subjects With Morning Stiffness at Each Visit|The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Subjects analyzed (as-observed) include only those who had morning stiffness at baseline.||participants|||Number
164216|NCT00235833|Secondary|Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)|Sum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts [TJC or SJC, respectively] and 20% improvement in 3 of the following 5 criteria: [1] Physician's global assessment (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein (CRP)|Every 6 weeks up to Week 24 and every 12 weeks thereafter|||Weeks||Standard Deviation|Mean
164217|NCT00235833|Secondary|Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein [CRP; mg/dL], a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mg/dL||Standard Deviation|Mean
164218|NCT00235833|Secondary|Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire [HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).], a component the of ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||units on a scale||Standard Deviation|Mean
164219|NCT00235833|Secondary|Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mm on scale||Standard Deviation|Mean
164220|NCT00235833|Secondary|Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mm on scale||Standard Deviation|Mean
164221|NCT00235833|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||mm on scale||Standard Deviation|Mean
164222|NCT00235833|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit|Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||SJC||Standard Deviation|Mean
164223|NCT00235833|Secondary|Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit|Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|||TJC||Standard Deviation|Mean
164314|NCT00234286|Secondary|Number of Individuals Who Died in Restraints|Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
164224|NCT00235833|Primary|Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)|Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts [TJC or SJC, respectively] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: [1] physician's global assessment of disease activity [PGA], [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of functional disability via a health assessment questionnaire [HAQ], and [5] C-reactive protein [CRP]) at each visit|Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)|Analysis was based on observed data.||participants|||Number
164225|NCT00235755|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.||participants|||Number
164226|NCT00235755|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline.|Baseline (Week -7 through 0), Weeks 8 and 16|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.||milliliters||Full Range|Median
164227|NCT00235755|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 16|Safety Population||participants|||Number
164228|NCT00235755|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 16|Safety Population||participants|||Number
164229|NCT00235755|Secondary|Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 4, 8, and 16|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Only participants with QOLIE-31-P data were included in the analysis.||scores on a scale||Standard Deviation|Mean
164230|NCT00235755|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population. Only participants with post-baseline PGI scores were included in the analysis.||scores on a scale||Standard Deviation|Mean
164231|NCT00235755|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 16/end of treatment phase|ITT EMEA Population||scores on a scale||Standard Deviation|Mean
164232|NCT00235755|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%.|Week 5 through Week 16|ITT EMEA Population||percentage of days||Full Range|Median
164233|NCT00235755|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 16|ITT FDA Population. Only participants who had post-baseline seizure data were included in the analysis.||percentage of days||Full Range|Median
164234|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 5 through Week 16|ITT EMEA Population||participants|||Number
164261|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)|Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164235|NCT00235755|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 16|ITT FDA Population. Only participants with post-baseline seizure data were included in the analysis.||participants|||Number
164236|NCT00235755|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population||participants|||Number
164237|NCT00235755|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population||participants|||Number
164238|NCT00235755|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population||participants|||Number
164239|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population||participants|||Number
164240|NCT00235755|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the No reduction category."|Baseline (Week -7 through Week 0), Week 1 through Week 16|ITT FDA Population||participants|||Number
164241|NCT00235755|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 5 through Week 16|ITT EMEA Population||Percent change in seizure frequency||Full Range|Median
164242|NCT00235755|Secondary|Number of Participants Who Were Responders and Non-responders During the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 16|ITT FDA Population||participants|||Number
164243|NCT00235755|Primary|Number of Participants Classified as Responders and Non-responders During the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 5 through Week 16|ITT European Medicines Evaluation Agency (EMEA) Population: all randomized participants who had received at least 1 dose of study drug in the Maintenance Phase and had at least 1 seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase.||participants|||Number
164244|NCT00235755|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)|Intent-to-Treat Food and Drug Administration (ITT FDA) Population: all randomized participants (P) who received at least 1 dose of study drug. Only participants with post-BL seizure data are included in this analysis.||percent change in seizure frequency||Full Range|Median
164245|NCT00235716|Other Pre-specified|All-cause Mortality|Survival analysis of death from any cause.|up to 4 years|Intention-to-treat analysis that includes all randomized participants.||participants|||Number
164262|NCT00235443|Secondary|Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)|Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.|Baseline to end of entire treatment phase visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164315|NCT00234286|Secondary|Individuals With an Intravenous Line|Presence of intravenous line infusing at time of death based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
164246|NCT00235716|Primary|Caregiver Activity Survey Change From Baseline|The Caregiver Activity Survey (CAS) was developed to measure the time caregivers spend aiding Alzheimer patients with their day-to-day activities. The CAS consists of six items that ask for an estimate in hours and minutes of the time that the caregiver spent during the previous 24 hours performing these particular activities. The six CAS items are as follows: 1) communication with the person, 2) using transportation, 3) dressing, 4) eating, 5) looking after one's appearance, and 6) supervising the person. The more caregiving hours the worse the patient's functioning level. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||hours per day||Standard Error|Least Squares Mean
164247|NCT00235716|Primary|Neuropsychiatric Inventory Change From Baseline|The Neuropsychiatric Inventory (NPI) assesses psychological and behavioral problems in patients with dementia. For each of twelve domains, there are four scores: frequency, severity, total frequency x severity, and caregiver distress. The frequency x severity total scores from each domain are summed for an overall total score that ranges from 0 to 144. The total caregiver distress scores are also summed for an overall total caregiver distress score that ranges from 0 to 60. The secondary endpoint for the trial will be the overall frequency times severity total score. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
164248|NCT00235716|Primary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline|The Alzheimer's Disease Assessment Scale (ADAS) is a 21-item scale designed to assess the severity of cognitive and non-cognitive behavioral impairments in patients with Alzheimer's disease. The cognitive portion of the scale (ADAS-cog) consists of 11 items to assess memory, language, and praxis functions. The ADAS-cog total score ranges from 0 (no errors) to 70 (severe cognitive impairment). Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
164249|NCT00235716|Primary|Mini-Mental State Examination Change From Baseline|The Mini-Mental State Examination (MMSE) briefly and objectively assess cognitive status in psychiatric patients with cognitive impairment. The MMSE questions are grouped into seven categories, each representing a different cognitive domain. The MMSE yields a total score that ranges from 0 for a patient who gives no correct response to a score of 30 for a patient who makes no errors. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
164250|NCT00235716|Secondary|Dependence Scale: Time to Event Analysis (Increase of of One Dependence Level)|The Dependence Scale assesses the level of assistance needed by patients with Alzheimer's disease for activities of daily living. The scale yields six levels of dependence: no assistance required (Level 0); requires occasional reminders (Level 1); requires frequent reminders and/or help with household chores (Level 2); needs daily supervision (Level 3); needs to be dressed, toileted or fed (Level 4); needs to be transferred, diapered or tube fed (Level 5).|Every 6 months to a maximum of 4 years|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||participants|||Number
164251|NCT00235716|Primary|Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline|The primary outcome of the study was the Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory. The ADCS/ADL Inventory is designed to assess functional abilities to perform activities of daily living in Alzheimer patients with a broad range of dementia severity. The total score ranges from 0 to 78 with higher scores indicating greater abilities. Outcome analysis is average least square means change from baseline.|6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline|Intention-to-treat analysis that includes all participants with baseline and at least one follow-up measurement.||units on a scale||Standard Error|Least Squares Mean
164252|NCT00235573|Secondary|Total Transcobalamin Measured at Intervals From Baseline to 48 Hours.||Baseline through 48 hours at intervals of 0, 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6, 7, 8, 9, 10, 11, 11.5, 12.5, 24, 48||||||
164253|NCT00235573|Primary|Change in Holo-transcobalamin|Holo-TC is a vitamin B12 carrier protein. Only vitamin B12 bound to holo-TC can be taken up by cells. Changes in holo-TC after an oral dose of vitamin B12 may provide a clinical test to assess vitamin B12 absorption. The change in holo-transcobalamin (holo-TC) from baseline was measured at timed intervals in response to supplemental vitamin B12 and compared to baseline. The purpose was to ascertain the time point at which holo-TC reaches the maximum concentration in the blood following a dose of vitamin B12 in subjects without defects in vitamin B12 absorption.|Holo-transcobalamin measured at 24 hours after baseline|The number of participants for analysis was per protocol.||pmol/L||Standard Deviation|Mean
164254|NCT00235456|Secondary|Hospital Length of Stay|The number of days patient stayed in the hospital after surgery.|time to hospital discharge after surgery|||days||Standard Deviation|Mean
164255|NCT00235456|Secondary|Staples Removed|Time to staples removed, measured in days|time to event after surgery|||days||Standard Deviation|Mean
164256|NCT00235456|Secondary|First Solid Food Intake|Time to restarting feeding after surgery, measured in days.|time to event after surgery|||days||Standard Deviation|Mean
164257|NCT00235456|Secondary|Return to Ambulation|time to return to ambulation after surgery, measured in days|time to event after surgery|||days||Standard Deviation|Mean
164258|NCT00235456|Secondary|Return of Bowel Function|Time to return of bowel function, measured in days.|time to event after surgery to discharge from hospital|||days||Standard Deviation|Mean
164259|NCT00235456|Primary|Incisional Surgical Wound Infection|Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.|0 to 14 days after surgery|||participants|||Number
164260|NCT00235443|Secondary|Change From Baseline in Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS)|Change from Baseline in quality of life using the SF-36 Health Survey – Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164264|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164265|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164266|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable (intolerable)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164267|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable (like poison oak)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164268|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable (raw skin)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164269|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable (freezing)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164270|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164271|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable (on fire)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164272|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness|"Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable (like a knife)."|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164273|NCT00235443|Secondary|Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity.|Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164274|NCT00235443|Secondary|Patient’s Global Impression of Change (PGIC) From Baseline in Pain.|Patient’s Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).|Baseline to Termination Visit|Safety population are subjects who took at least one dose of lacosamide (LCM).||Participants|||Number
164275|NCT00235443|Secondary|Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).|Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164276|NCT00235443|Secondary|Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).|Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.|Baseline to end of entire treatment phase (maximum study period of 2.8 years).|Safety population are subjects who took at least one dose of lacosamide (LCM).||Units on a scale||Standard Deviation|Mean
164277|NCT00235443|Primary|Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.|Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).|Throughout the study up to a maximum study period of 2.8 years|Safety population are subjects who took at least one dose of lacosamide (LCM).||Participants|||Number
164278|NCT00235391|Secondary|The Change in Serum Ferritin Values From Baseline Through Completion of the Study|The number of participants with Improvement, No Change or Worsening in Serum ferritin category levels at the end of the study compared to baseline. Serum ferritin levels in µg/L were divided into to 6 categories: (<1000), (1000-<2500), (2500-<4000), (4000-<5500), (5500-<7000) and (>=7000). Improvement was defined as a shift to a lower category at the end of study compared to the category at baseline. Worsening was defined as a shift to a higher category at the end of the study compared to the category at baseline. No change was no change in category at end of study from baseline.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|Safety population defined as all participants who received at least one dose of study drug. This analysis did not include participants with unknown status at baseline and/or at the end of the study.||Participants|||Number
165611|NCT00201409|Secondary|Days Without Organ Failure|Non-respiratory|Measured at Day 28|||days||Standard Deviation|Mean
164279|NCT00235391|Primary|Safety Profile of Deferasirox Based Upon Drug Administration and Reporting of Serious Adverse Events|Safety as assessed by the number of participants with death, serious adverse events (SAE), and/or Adverse Events (AEs) leading to study drug interruption or discontinuation. Note: only treatment emergent AEs are summarized.|Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks)|The safety population, comprising all participants who received at least one dose of deferasirox during the study, was used in the analyses.||Participants|||Number
164280|NCT00235326|Primary|Number of Participants With Post Infectious Irritable Bowel Syndrome||8 years|||participants|||Number
164281|NCT00234884|Primary|Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||units on a scale||Standard Deviation|Mean
164282|NCT00234884|Primary|American College of Rheumatology 70% (ACR70) Response Rate|ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||participants|||Number
164283|NCT00234884|Primary|American College of Rheumatology 50% (ACR50) Response Rate|ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||percentage of participants|||Number
164284|NCT00234884|Primary|American College of Rheumatology 20% (ACR20) Response Rate|ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||percentage of participants|||Number
164285|NCT00234884|Primary|Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)|DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.|Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value|Results are presented as observed. The number of participants evaluated is indicated for each time point below.||units on a scale||Standard Deviation|Mean
164286|NCT00234832|Secondary|Risk of Experiencing Cardiovascular Death Included in the POE|For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
164287|NCT00234832|Secondary|Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE|For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
164288|NCT00234832|Secondary|Risk of Experiencing a Nonfatal Stroke Included in the POE|For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
164289|NCT00234832|Secondary|Risk of Experiencing a Nonfatal MI Included in the POE|For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
164290|NCT00234832|Secondary|Risk of Experiencing a POE or a Revascularization Procedure|This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
164316|NCT00234286|Secondary|Individuals With a Nasogastric Tube|Presence of nasogastric tube based on abstraction of electronic medical record|Pre and Post Intervention|||participants|||Number
164291|NCT00234832|Secondary|Risk of Death From Any Cause (All-cause Mortality)|For each subject who died, the time to death was evaluated using time-to-event analysis.|From randomization up to 6 years|Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.||Participants|||Number
164292|NCT00234832|Primary|Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)|For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.|From randomization up to 6 years|Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.||Participants|||Number
164293|NCT00234494|Secondary|Duration of Response for Responding Patients|To estimate duration of response for responding patients.|36 months|Data for this secondary outcome measure was not collected or analyzed.|||||
164294|NCT00234494|Secondary|Estimate Response Rates|To estimate rate of partial response (PR), complete response (CR) and overall response (PR plus CR).|36 months|||percentage of participants|||Number
164295|NCT00234494|Secondary|Overall Survival Time|To estimate overall survival time in months.|36 months|||months||95% Confidence Interval|Median
164296|NCT00234494|Primary|Progression Free Survival|- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.|36 months|||months||95% Confidence Interval|Median
164297|NCT00233519|Primary|The Number of Study Participants Who Safely Tolerated Somatokine|Safety and tolerability was measured via interval laboratory studies,electrocardiograms, echocardiograms, ultrasounds of the abdomen and pelvis, dual energy x-ray absorptiometry (DEXA) studies, chest and neck x-rays, and serial physical examinations. The participants had six inpatient evaluations at the University of Rochester General Clinical Research Center (Weeks 0, 8, 16, 24, 28, and 40) and nine outpatient evaluations. Patients also completed side effects diaries to record any adverse events in the interval time between inpatient and outpatient evaluations.|24 weeks|||participants|||Number
164298|NCT00233454|Secondary|Overall Survival (OS)|Overall survival will be assessed after 12 cycles of treatment, with each cycle being 28 days (4 weeks) in length. 12 cycles of treatment is considered to be about 11 months.|11 months|||participants|||Number
164299|NCT00233454|Primary|Subjects With Clinical Response [Partial Response (PR) + Complete Response (CR)]|"Clinical Response [PR + CR] will be assessed after 2 cycles of treatment, with each cycle being 28 days (4 weeks) in length.~Except as otherwise noted, the minimum criteria for PR is improvement by at least 50% from the baseline value towards the indicated value for one or more of the criteria below:~BONE MARROW & BLOOD~ANC <1000/uL~Hb <10 g/dL~Platelets >100,000/uL LIVER~If hepatomegaly with ascites, decrease in frequency of paracenteses by 50%~Elevated enzyme levels > upper limit of normal (ULN)~Hypoalbuminemia < ULN~Portal hypertension > ULN SPLEEN~If palpable splenomegaly with hypersplenism/thrombocytopenia, hypersplenism markers improved GI TRACT~If malabsorption with hypoalbuminemia and/or weight loss, albumin improved BONES~If huge osteolyses or/and severe osteoporosis with pathologic fractures, partial resolution of osteolyses~Subjects with PR or greater continue, those without response discontinue."|2 months|||participants|||Number
164300|NCT00233402|Secondary|Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.||Day 0|||percentage of participants||95% Confidence Interval|Number
164301|NCT00233402|Secondary|Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.|"The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).~The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately."|Day 0|||Percetange of lesion||95% Confidence Interval|Number
164302|NCT00233402|Primary|Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.||9 months|ITT population||percentage of participants|||Number
164303|NCT00233402|Primary|Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light||Day 0|Analysis was based on ITT population||percentage of participants||95% Confidence Interval|Number
164304|NCT00234286|Secondary|Individuals With a Palliative Care Consultation|Palliative Care Consultation based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164305|NCT00234286|Secondary|Individuals With an Advance Directive|Presence of advance directive based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164306|NCT00234286|Secondary|Individuals With Pastoral Care Visit|Pastoral Care Visit based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164307|NCT00234286|Secondary|Sublingual Administration|Sublingual administration of medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164308|NCT00234286|Secondary|Individuals Who Received Scopolamine|Administration of scopolamine (for death rattle) based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164309|NCT00234286|Secondary|Individuals Who Received Benzodiazepine Medication|Administration of benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164310|NCT00234286|Secondary|Individuals With an Order for Benzodiazepine Medication|Order for benzodiazepine medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164311|NCT00234286|Secondary|Individuals Administered Antipsychotic Medication|Administration of antipsychotic medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164312|NCT00234286|Secondary|Individuals With an Order for Antipsychotic Medication|Order for antipsychotic medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164313|NCT00234286|Secondary|Individuals Administered of Opioid Medication|Administration of opioid medication based on abstraction of medical record|Pre and Post Intervention|||participants|||Number
164320|NCT00234104|Primary|Body Weight|The body weight change from baseline following final trial drug administration|Baseline, at the time of final trial drug administration|1 Subject of Placebo arm who experienced a serious adverse event was excluded from efficacy analysis set because the emergency code was broken.||Kg||Standard Deviation|Mean
164321|NCT00234078|Post-Hoc|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Week 12|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. The CFB in the LGCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett’s t-test.|Baseline, 12weeks|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis||scores on a scale||Standard Deviation|Mean
164322|NCT00234078|Post-Hoc|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Week 12|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The CFB in the FCS scores were compared between the 0.5, 1 and 2% rebamipide group and the placebo group using a Dunnett’s t-test|Baseline, 12week|From the FAS of 290 patients, 218 patients who had no punctal plug insertion or punctal occlusion and who had a baseline schirmer test value of equal to or less than 5 mm for the eye evaluated for efficacy were selected and subjected to exploratory data analysis||scores on a scale||Standard Deviation|Mean
164323|NCT00234078|Primary|Change in Primary Ocular Discomfort (POD) Score From Baseline to Last Observation Carried Forward (LOCF)|POD indicates the ocular symptom most bothersome to the patient. POD selected by each patient from among the following ocular symptoms; Foreign body sensation, Dryness, Photophobia, Eye pain and Blurred vision. POD was scored from 0 through 4; a score of 0 indicated no symptoms and a score of 4 indicated very severe symptoms. 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|Baseline, 12 weeks|||scores on a scale||Standard Deviation|Mean
164324|NCT00234078|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. The change from baseline (CFB) to LOCF at the end of instillation (LOCF endpoint) was used to analyze dose-response. A general linear model was used to examine if slope parameters were not equal to zero.|baseline, 12 weeks|||scores on a scale||Standard Deviation|Mean
164325|NCT00234065|Other Pre-specified|Number of Patients With First Occurrence of Haemorrhagic Event|The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
164326|NCT00234065|Secondary|Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
164327|NCT00234065|Secondary|Number of Deaths From Any Cause|Number of deaths from any cause. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
164328|NCT00234065|Secondary|Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||participants|||Number
164329|NCT00234065|Secondary|Number of Patients With First Recurrence of Cerebral Infarction||From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])|||participants|||Number
164330|NCT00234065|Primary|Numbers of Patients With First Occurence of Stroke|The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients’ treatment assignment, adjudicated all trial endpoints.|From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])|Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||participants|||Number
164331|NCT00234039|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
168729|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6||Month 6|||L||Standard Deviation|Mean
164332|NCT00234039|Secondary|Recurrence-free Survival (RFS)|Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.|1 year|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
164333|NCT00234039|Primary|Complete Response Rate at the End of Induction|Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy|Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
164334|NCT00234039|Secondary|Overall Survival (OS)|Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.|1 year|All eligible patients who started treatment were included in the analysis||percentage of participants|||Number
164335|NCT00233987|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
164336|NCT00233987|Secondary|Overall Survival|Measured from date of registration to date of death due to any cause or last contact|At day 60, then every 6 months for 2 years, then annually for a total of 7 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
164337|NCT00233987|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis. Five patients with no evidence of disease at baseline were excluded.||participants|||Number
164338|NCT00233987|Primary|2-year Progression-free Survival|Measured from date of randomization to date of first observation of progressive disease, or death due to any cause|At day 60, then every 6 months for 2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
164339|NCT00233948|Primary|Overall Response Rate (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|After 3 cycles of treatment, up to 2 years.|Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.||participants|||Number
164340|NCT00233948|Primary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. If PK analysis of 3 patients treated at 4250 mg bid and 3 patients at 3000 mg bid confirms that the first dose area under the curve and Cmax of nelfinavir does not increase appreciably at doses greater than 1875 mg BID then 3000 mg BID will be deemed the MTD.|4 weeks from start of treatment, up to 2 years|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.||mg|||Number
164341|NCT00233948|Primary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.||participants with DLTs|||Number
164342|NCT00233324|Secondary|Cerebral Palsy||18-22 months||||||
164343|NCT00233324|Secondary|Necrotizing Enterocolitis (NEC)||120 days||||||
164344|NCT00233324|Secondary|Received Postnatal Steroids||120 days||||||
164345|NCT00233324|Secondary|Blindness in at Least One Eye||18-22 months||||||
164346|NCT00233324|Secondary|Pulse Oximetry Values > 90%||120 days||||||
164347|NCT00233324|Secondary|Duration of Oxygen Supplementation||120 days||||||
164348|NCT00233324|Secondary|Endotracheal Intubation||Before 10 minutes of age||||||
164349|NCT00233324|Secondary|Threshold ROP Requiring Surgery||120 days||||||
164350|NCT00233324|Secondary|Periventricular Leukomalacia (PVL)||120 days||||||
164351|NCT00233324|Secondary|Severe Intraventricular Hemorrhage (IVH)||120 days||||||
164352|NCT00233324|Secondary|Death||18-22 months||||||
164353|NCT00233324|Secondary|Bronchopulmonary Disease (Using the Physiologic Definition of BPD)||36 weeks||||||
164354|NCT00233324|Secondary|Incidence of Air Leaks||120 days||||||
164355|NCT00233324|Secondary|Received Surfactant Treatment||120 days||||||
164356|NCT00233324|Secondary|Survival Without Ventilation||By day 7||||||
164357|NCT00233324|Secondary|Duration of Mechanical Ventilation||During entire NICU stay||||||
164358|NCT00233324|Secondary|Death or Neurodevelopmental Impairment||18-22 months|||participants|||Number
164359|NCT00233324|Other Pre-specified|Apgar Score||5 minutes||||||
164360|NCT00233324|Primary|Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)||55 weeks|49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome||participants|||Number
164362|NCT00233103|Primary|Depression at End of Treatment|"Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention.~The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression."|end of treatment, average of 10 weeks|||units on a scale||Standard Deviation|Mean
164363|NCT00233103|Secondary|Life-3|Life-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7.|Immediately post-intervention at 10 weeks|||units on a scale||Standard Deviation|Mean
164364|NCT00233103|Secondary|BAI|The Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression|Immediately post-intervention|||units on a scale||Standard Deviation|Mean
164365|NCT00233103|Primary|Depression at Baseline|"The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.~Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline."|baseline|||units on a scale||Standard Deviation|Mean
164366|NCT00233090|Secondary|Quality of Life|quality of life|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164367|NCT00233090|Secondary|Participation|participation|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164368|NCT00233090|Secondary|Health Status|health status|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164369|NCT00233090|Secondary|Sleep Quality|sleep quality|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164370|NCT00233090|Secondary|Pain|pain|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164371|NCT00233090|Secondary|Mood|mood|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164372|NCT00233090|Secondary|Cognitive Performance|Cognitive performance|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164373|NCT00233090|Primary|Fatigue|Self-report of fatigue|comparison pre and post treatment|Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.|||||
164374|NCT00233064|Primary|Number and Percentage of Participants With Immune Reactivity|Presence of anti-palivizumab antibodies|Day 240-300 follow up|Participants who received at least 2 doses of study drug and had at least 1 blood sample collected (at baseline or Study Day 240-300) were included in the analysis. This included 206 subjects in Arm 1 and 200 subjects in Arm 2. Of these subjects, 191 (Arm 1) and 188 (Arm 2) had adequate blood samples for analysis. This analysis was per protocol.||Participants|||Number
164375|NCT00232739|Secondary|Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge|Procedure success defined as achievement of a final diameter stenosis of less than 50 percent (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay|From post-procedure to hospital discharge|Number of participants without missing procedure success data||Percentage of participants||95% Confidence Interval|Mean
164376|NCT00232739|Secondary|Percentage of Participants Who Achieved Device Success at Post-procedure|Device success was defined as achievement of a final residual diameter stenosis of less than 50 percent as measured by QCA, using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used|At post-procedure|All participants||Percentage of participants||95% Confidence Interval|Mean
164377|NCT00232739|Secondary|Percentage of Participants Who Achieved Lesion Success at Post-procedure|Lesion success defined as the attainment of <50 percent residual stenosis (by QCA) using any percutaneous method|At post-procedure|Number of Participants without missing lesion success data||Percentage of participants||95% Confidence Interval|Mean
164378|NCT00232739|Secondary|Average Stent Obstruction Volume at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants with Stent Obstruction Volume data at 6 months post-procedure||mm3||Standard Deviation|Mean
164379|NCT00232739|Secondary|Average Lumen Volume (mm3) at 6 Months Post-procedure||From post-procedure to 6 months|The number of participants who had Lumen Volume data at 6 months post-procedure||mm3||Standard Deviation|Mean
164380|NCT00232739|Secondary|Average Stent Obstruction Volume at Post-procedure|Stent obstruction Volume equals 100 * [1-(lumen volume/baseline stent volume)]; usually this is equal to zero at baseline, since the stent is freshly implanted and no obstruction is expected|At post-procedure|Number of participants who had Stent Obstruction Volume data at post-procedure||mm3||Standard Deviation|Mean
164381|NCT00232739|Secondary|Average Lumen Volume (mm3) at Post-procedure||At Post-procedure|The number of participants who had lumen volume data at post-procedure||mm3||Standard Deviation|Mean
164562|NCT00229723|Secondary|Overall Survival|Percentage of participants who are alive at 2 years (calculated using the Kaplan-Meier method, which allows for patients who do not have complete follow-up (censored observations)).|Overall survival assessed at 2 years|||Percentage of participants|||Number
164382|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure|TVF was defined as any Target vessel revascularization, Q wave or non-Q wave MI, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.||Percentage of participants||95% Confidence Interval|Mean
164383|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.|TVR was defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations were those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis being greater than or equal to 50 percent measured by QCA.|From post-procedure to 6 months and 9 months follow-up|The number of participants who had sufficient 9 months post-procedure follow-up or had the event prior to 9 months.||Percentage of participants||95% Confidence Interval|Mean
164384|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.|TLR was defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel.|From post-procedure to 6 months and 9 months|The number of participants who had sufficient follow-up or who had an event prior to the end of follow-up.||Percentage of participants||95% Confidence Interval|Mean
164385|NCT00232739|Secondary|Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.||From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.||mm||Standard Deviation|Mean
164386|NCT00232739|Secondary|Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.|In-stent restenosis was defined as greater than or equal 50 percent diameter stenosis within the stented segment at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis results.||Percentage of participants||95% Confidence Interval|Mean
164387|NCT00232739|Secondary|Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up|The percentages are cumulative up to each of the scheduled post-procedure follow-up: 30 days, 6, 9, and 12 months, and 2, 3, 4 and 5 years. Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure to 4 years|The number of participants who had four years post-procedure follow up or who had at least one event prior to the end of follow-up.||Percentage of participants||95% Confidence Interval|Mean
164388|NCT00232739|Primary|Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure|In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.|From post-procedure to 6 months|The number of participants with six months follow up and non-missing six months binary angiographic restenosis (BAR) results.||Percentage of participants||95% Confidence Interval|Mean
164389|NCT00232596|Secondary|Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase|The number of participants with recorded weight gain of >=7% over their baseline weight was measured.|Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase|Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed.||participants|||Number
164390|NCT00232596|Secondary|Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase|Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 18 minus the value at Baseline.|Baseline (Week -7 through Week 0), Weeks 10 and 18|Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed.||milliliters||Full Range|Median
164391|NCT00232596|Secondary|Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)|A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.|Week 1 through Week 24|Safety Population||participants|||Number
164392|NCT00232596|Secondary|Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)|Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.|Week 1 through Week 24|Safety Population||participants|||Number
164393|NCT00232596|Secondary|Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.|End of Baseline (Week 0), Weeks 6, 10, and 18|Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Participants who were cognitively impaired and could not complete the QOLIE-31-P assessment were not analyzed. The number of participants analyzed differs by week because not all participants completed the questionnaire at the indicated weeks.||scores on a scale||Standard Deviation|Mean
164394|NCT00232596|Secondary|Patient Global Impression (PGI) Score at the End of the Maintenance Phase|PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had a PGI score were analyzed.||scores on a scale||Standard Deviation|Mean
164395|NCT00232596|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase|Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Week 18/end of treatment phase|ITT Population for EMEA review. Only participants who had CGI-I scores were analyzed.||scores on a scale||Standard Deviation|Mean
164396|NCT00232596|Secondary|Percentage of Seizure-free Days During the Maintenance Phase|A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in the DB period x 100%.|Week 7 through Week 18|ITT Population for EMEA review||percentage of days||Full Range|Median
164397|NCT00232596|Secondary|Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)|A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.||percentage of days||Full Range|Median
164398|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the Maintenance Phase|Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.|Week 7 through Week 18|ITT Population for EMEA review||participants|||Number
164399|NCT00232596|Secondary|Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)|Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.|Week 1 through Week 18|ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis.||participants|||Number
164400|NCT00232596|Secondary|Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline|New seizure types included those seizures which were not reported by any participant at Baseline.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review||participants|||Number
164401|NCT00232596|Secondary|Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase|Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review.||participants|||Number
164402|NCT00232596|Secondary|Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review||participants|||Number
164403|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the 0-10% increase category.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review||participants|||Number
164404|NCT00232596|Secondary|Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories|Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data were included in the “No reduction” category.|Baseline (Week -7 through Week 0), Week 1 through Week 18|ITT Population for FDA review||participants|||Number
164405|NCT00232596|Secondary|Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase|28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 7 through Week 18|ITT Population for EMEA review||percent change in seizure frequency||Full Range|Median
164406|NCT00232596|Secondary|Number of Participants Who Were Responders and Non-responders in the DB Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.|Week 1 through Week 18|ITT Population for FDA review||participants|||Number
164407|NCT00232596|Primary|Number of Participants Who Were Responders and Non-responders in the Maintenance Phase|Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.|Week 7 through Week 18|Intent-to-Treat (ITT) Population for European Medicines Agency (EMEA) review: all randomized participants who received at least one dose of study drug in the Maintenance Phase and had at least one seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase||participants|||Number
164408|NCT00232596|Primary|Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)|28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.|Baseline (Week -7 through Week 0), Week 1 through Week 18|Intent-to-Treat (ITT) Population for Food and Drug Administration (FDA) review: all randomized participants (par.) who received at least one dose of the study drug. Only par. with baseline and post-baseline measures were analyzed. Two par. in each treatment arm did not have post-baseline measures and were thus not included in this analysis.||percent change in seizure frequency||Full Range|Median
164409|NCT00232583|Secondary|Quality of Life, Treatment Satisfaction, and Treatment Compliance||72months||||||
164410|NCT00232583|Secondary|Inflammatory Markers||72 months||||||
164411|NCT00232583|Secondary|Weight Change||72 months||||||
164412|NCT00232583|Secondary|Glycemic Control||72 months||||||
164413|NCT00232583|Secondary|Insulin Resistance (HOMA)||72 months||||||
164414|NCT00232583|Primary|Beta-cell Function|C-peptide AUC during a 3-HR MMCT|Change from 0 to 72 months|||ng*min/ml||Standard Deviation|Mean
164415|NCT00232557|Secondary|Participants With Oral Corticosteroid Use|Number of participants found to have any use of oral corticosteroids related to asthma during one year|1 year|||participants|||Number
164416|NCT00232557|Primary|Participants With Unscheduled Asthma-related Visits|Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.|1 year|||participants|||Number
164417|NCT00232544|Secondary|Daytime Vigilance|A measure of behavioral alertness. Specifically the metric we used was the mean reaction time, the time it took for a subject to respond to a visual stimulus (light displayed on a screen at random intervals) by hitting a button.|12 months|||ms||95% Confidence Interval|Mean
164418|NCT00232544|Primary|Objective CPAP Use|Mean nightly hours of CPAP use over 12 months|12 months|||log(hours/night)||95% Confidence Interval|Mean
164419|NCT00232479|Secondary|Safety and Tolerability|the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability|from the first dose of chemotherapy until surgery which was approximately 16 weeks.|48 patients signed an initial informed consent. 2 withdrew consent before treatment. 2 withdrew after starting treatment. Only 44 are evaluable for primary endpoint because 2 did not go for surgery.||participants|||Number
164420|NCT00232479|Primary|Number of Patients With Pathologic Complete Response (pCR)|pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.|determined at the time of surgery which is approximately 16 weeks from the beginning of treatment|48 patients signed consent but only 44 were evaluable. To be evaluable the patient must have received at least one dose of chemo and then had surgery. Two patients withdrew consent before treatment and two patients did not have surgery. So 44 are evaluable for the primary endpoint||participants|||Number
164421|NCT00232180|Secondary|Number of Participants With New Onset Diabetes Mellitus (DM)|The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of diabetes mellitus at baseline and “n” signifies participants evaluated at that time point.||participants|||Number
164422|NCT00232180|Secondary|Number of Participants With New Onset Atrial Fibrillation or Flutter|New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: Here 'N' (Number of Participants Analyzed) signifies those who did not report a history of atrial fibrillation at baseline and “n” signifies participants evaluated at that time point.||participants|||Number
164423|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)|First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164605|NCT00228384|Secondary|Target Lesion Revascularization (TLR)|This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study.|3 years|||percentage of participants|||Number
164424|NCT00232180|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)|First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164425|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)|First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164426|NCT00232180|Secondary|Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)|First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164427|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164428|NCT00232180|Secondary|Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)||Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164429|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)|First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164430|NCT00232180|Secondary|Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164431|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)|Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164432|NCT00232180|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)|First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164433|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)|Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164434|NCT00232180|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism).|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164435|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)|Death due to any cause.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164436|NCT00232180|Secondary|Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)|Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol. Here “n” signifies participants evaluated at that time point.||participants|||Number
164437|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)|FAS using ITT principle: All randomized participants, followed for mortality and other major endpoints for the duration of the double blind treatment period, regardless of compliance with the study drug and the protocol.||participants|||Number
164438|NCT00232180|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date|CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.|Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)|Full analysis set (FAS) using intent-to-treat (ITT) principle: All randomized participants, followed for mortality, other major endpoints for duration of double blind treatment period, regardless of compliance with study drug and protocol. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.||participants|||Number
164439|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table|Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).|Baseline-Week 14 (Endpoint)|ITT Population||participants|||Number
164440|NCT00232141|Secondary|Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table|Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)|Baseline-Week 14 (Endpoint)|ITT Population; Pregabalin weight range- 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived. Placebo weight range- 2.83, 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived||participants|||Number
164441|NCT00232141|Secondary|Gracely Pain Scale Score|The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.|Week 14|ITT Population||score on scale||Standard Deviation|Mean
164442|NCT00232141|Secondary|Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population||participants|||Number
164443|NCT00232141|Secondary|Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)|Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline, Week 14|ITT Population||participants|||Number
164444|NCT00232141|Secondary|Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks|Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population||participants|||Number
164445|NCT00232141|Secondary|Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain|Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.|Baseline-Week 14 (Endpoint)|ITT Population||participants|||Number
164446|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164447|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164448|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164449|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164450|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164451|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164452|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164453|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164454|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14 and Endpoint|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164455|NCT00232141|Secondary|Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164456|NCT00232141|Secondary|Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)|Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.|Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF|ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164457|NCT00232141|Secondary|Shift in Hospital Anxiety and Depression (HADS) Subscales|Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.|Baseline, Week 14|ITT Population||participants|||Number
164458|NCT00232141|Secondary|Change in NRS-Sleep Interference Scores|Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.|Baseline, Weeks 1-14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164459|NCT00232141|Other Pre-specified|Duration Adjusted Average Change From Baseline in NRS Pain Scores|Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation – mean at baseline)x(proportion of planned study duration that the subject completed).|Weekly: Week 1 - Week 14|ITT Population||score on scale||Standard Error|Least Squares Mean
164460|NCT00232141|Secondary|Change in Quantitative Assessment of Neuropathic Pain (QANeP)|Change in a quantitative assessment of the participants’ neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164461|NCT00232141|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164462|NCT00232141|Secondary|Patient Global Impression of Change (PGIC) Rating|PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Baseline, Week 14, Endpoint-LOCF|ITT Population||participants|||Number
164463|NCT00232141|Secondary|Categorized Patient Global Impression of Change (PGIC)|The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).|Baseline, Week 14|ITT Population||participants|||Number
164464|NCT00232141|Secondary|Change From Baseline for NRS-Sleep Interference Scores|11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain])|Baseline, Week 14|ITT Population||score on scale||Standard Error|Least Squares Mean
164465|NCT00232141|Secondary|Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores|Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from “no pain” (0) to “pain as bad as you can imagine” (10)|Baseline, Week 14|ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164466|NCT00232141|Secondary|Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales|Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).|Baseline, Week 14|ITT population||score on scale||Standard Error|Least Squares Mean
164467|NCT00232141|Secondary|Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices|Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 – 100 and higher scores reflect more impairment. Subscales “sleep adequacy”, “quantity of sleep” and “optimal sleep” low scores reflect impairment.|Baseline, Week 14|ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164468|NCT00232141|Other Pre-specified|Responders - Decreases of at Least 30% in Mean Weekly Pain Score|Number of subjects that experienced at least 30% decrease in mean weekly pain.|Weeks 1-14 endpoint BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward||participants|||Number
164469|NCT00232141|Other Pre-specified|Responders- Decreases of at Least 50% in Mean Weekly Pain Score|Number of subjects that experienced at least a 50% decrease in mean weekly pain.|Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward||participants|||Number
164470|NCT00232141|Other Pre-specified|Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)|Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR)|Baseline, Weeks 1 - 14 and Endpoint-BOCF|ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
164485|NCT00231465|Secondary|Overall Survival (OS) Rate|OS was calculated from the date of enrollment to the date of death. All 44 treated were assessed for OS, with a minimum follow-up of 19 months.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005||Months||95% Confidence Interval|Median
170547|NCT00123643|Primary|Flow Mediated Dilation|Measure of endothelial function|change from baseline to 6 months|All completers were analyzed||percent change||Standard Deviation|Mean
164471|NCT00232141|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 14|ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose & had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99).||score on scale||Standard Error|Least Squares Mean
164472|NCT00231816|Other Pre-specified|GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP||titers||95% Confidence Interval|Geometric Mean
164473|NCT00231816|Other Pre-specified|GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.||titers||95% Confidence Interval|Geometric Mean
164474|NCT00231816|Other Pre-specified|Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination|GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly|4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.||titers||95% Confidence Interval|Geometric Mean
164475|NCT00231816|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination|"GMFR of the VZV gpELISA antibody titers from prevaccination~to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine"|prevaccination to 4 weeks postvaccination|The analysis was based on the per protocol population defined as participants who had valid GMFR results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)||ratio||95% Confidence Interval|Geometric Mean
164476|NCT00231816|Primary|Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses|The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.|4 weeks|The primary analysis was based on the per protocol population defined as participants who had valid GMT results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP).||gpELISA units/mL||95% Confidence Interval|Geometric Mean
164477|NCT00231777|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.||Participants|||Number
164478|NCT00231777|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.||Participants|||Number
164479|NCT00231777|Primary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline and 24 hours|"All patients as treated (APaT) which included all patients who received active study therapy.~patients in the MK0517 40 mg treatment group were randomized but did not have at least one post-baseline laboratory test and therefore were not counted as part of the N analyzed."||Participants|||Number
164480|NCT00231777|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Baseline and 24 hours|All patients as treated (APaT) which included all patients who received active study therapy.||Participants|||Number
164481|NCT00231478|Secondary|Adverse Experiences|The adverse events are captured in the AE and SAE section of this database|infusion to 15 days post treatment|Eight of the 157 treated subjects (six and two in the 20- and 40-μg/kg dose groups,respectively) experienced a treatment-emergent serious adverse event up to 15 days after the treatment evaluation period.||number of participants|||Number
164482|NCT00231478|Secondary|Time to First Vomiting Episode|Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up.|0-24h after time of extubation|Evaluable Patients||hours||Standard Error|Mean
164483|NCT00231478|Secondary|Number of Patients With no Vomiting|No vomiting describes no emesis during the first 24 hours|0-24h after time of extubation|Evaluable Patients||participants|||Number
164484|NCT00231478|Primary|Number of Patients With no Vomiting|Number of patients with no vomiting is described as no emesis up to 2 hours after surgery|0-2h after end of surgery (time of extubation)|Evaluable Patients||participants|||Number
164486|NCT00231465|Secondary|Progression Free Survival (PFS) Rate|PFS was calculated from the date of enrollment to the date of progression. All 44 treated were assessed for PFS, with a minimum follow-up of 19 months. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Duration of time on study, an average of 19 months|All participants who initiated therapy between March 2003 and May 2005||Months||95% Confidence Interval|Median
164487|NCT00231465|Primary|Overall Response Rate (ORR)|Response Rate: Complete Response (CR) + Partial Response (PR). To determine the response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With MPE) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): * Complete Response (CR)- Disappearance of all target lesions; * Partial Response (PR)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; * Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; * Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Duration of time on study, an average of 19 months|Response was evaluable in 42 of the 44 patients.||percentage of participants||95% Confidence Interval|Mean
164488|NCT00231309|Secondary|Hospital Length of Stay|hospital length of stay of each patient enrolled, an average of 5 weeks.|inpatient hospital stay|||average days||Standard Deviation|Median
164489|NCT00231309|Primary|Numbers of Participants With Disease-free Survival.|Evaluate the numbers of participants with disease-free survival|260 days|||participants|||Number
164490|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 12 months|Patients who had at least 330 days clinical follow-up.||Percentage of participants|||Number
164491|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge||Percentage of participants|||Number
164492|NCT00231283|Secondary|Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later|Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).|From post-procedure up to 30 days|Patients who had 30 days clinical follow-up.||Percentage of Participants|||Number
164493|NCT00231283|Primary|Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge|Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion|From post-procedure up to hospital discharge|Patients who were followed up to hospital discharge||Percentage of Participants|||Number
164494|NCT00231179|Primary|Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|child age 5 years (plus or minus 1 month)|||Percentage of participants|||Number
164495|NCT00231179|Primary|Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)|||Percentage of participants|||Number
164496|NCT00231179|Primary|Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)|||percentage of participants|||Number
164497|NCT00231179|Primary|Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants|Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems. Respondents are asked to rate 99 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on the past two months. The range of possible values is 0-100. Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).|at child age of 5 years (plus or minus 1 month)|Number of mothers/caregivers evaluated at 60 month visit.||percentage of participants|||Number
171564|NCT00113399|Primary|Overall Survival||Date of death or last follow-up|This study terminated early with 15 subjects out of 240 subjects accrued, therefore no analyses were performed.|||||
164498|NCT00231179|Primary|Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)|Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III). The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age. The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score. These scores have a mean of 100 and a standard deviation of 15. The range of possible values is 50 (worst value) to 150 (best value).|5 years of age (plus or minus 1 month)|Number of children evaluated at 60 month visit.||Scores on a scale||Standard Deviation|Mean
164499|NCT00231153|Secondary|Catheter Colonization (CC)|CC was defined as a positive culture of any catheter segment >= 15 CFU (roll-plate method) or >999 CFU/ml (sonication method) or a positive blood culture drawn via the catheter where the time-to-positivity difference of catheter line vs. peripheral blood >120 minutes (catheter positive first).|study completion|MITT Among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for catheter colonization prior to death (as determined EC adjudication).||Events|||Number
164500|NCT00231153|Secondary|Microbiologically-confirmed LCSI|MCLCSI is a subset of EC-adjudicated LCSI for any catheter where there is (1) growth of a recognized pathogen from a culture or any purulence or exudate from the same insertion site, or (2) a positive culture of the subcutaneous segment of the catheter meeting criteria for significant colonization.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for MCLCSI prior to death (as determined by EC adjudication).||Events|||Number
164501|NCT00231153|Primary|Local Catheter Site Infection (LCSI)|LCSI was defined as a study catheter showing any 2 of the following criteria: erythema >= 2; edema >= 2; presence of purulence, pain, or abnormal study catheter site warmth. In addition, an action must have been taken that indicated a LCSI was present.|study completion|MITT among Survivors: patients from the MITT population (all ITT patients who did not have a baseline BSI) who did not die on study, or who died and were positive (indeterminate or failure) for LCSI prior to death (as determined by EC adjudication).||Events|||Number
164502|NCT00231114|Other Pre-specified|Hospitalizations for Respiratory Symptoms||12 Months|||Events/Subject/Year|||Number
164503|NCT00231114|Other Pre-specified|Emergency Room Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Events/Subject/Year||Standard Deviation|Mean
164504|NCT00231114|Other Pre-specified|Unscheduled Physician Office Visits for Respiratory Symptoms||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Events/Subject/Year||Standard Deviation|Mean
164505|NCT00231114|Other Pre-specified|Days Lost From Work/School/Other Activities Due to Asthma||12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Days/Subject/Year||Standard Deviation|Mean
164506|NCT00231114|Other Pre-specified|Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids|Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent of Subjects|||Number
164507|NCT00231114|Other Pre-specified|Rate of Severe Exacerbations Requiring Systemic Corticosteroids|Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Events/Subject/Year||Standard Deviation|Mean
164508|NCT00231114|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
164509|NCT00231114|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
164510|NCT00231114|Secondary|Morning Peak Expiratory Flow (amPEF) (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||L/Min||Standard Deviation|Mean
164511|NCT00231114|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient’s FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Units on a scale||Standard Deviation|Mean
164512|NCT00231114|Secondary|Percent Days Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
164524|NCT00230802|Secondary|Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.||9 months|||participants|||Number
164513|NCT00231114|Secondary|Number of Puffs of Rescue Medication Used (Change From Baseline)|Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Puffs/7 Days||Standard Deviation|Mean
164514|NCT00231114|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Units on a scale||Standard Deviation|Mean
164515|NCT00231114|Secondary|Percent Symptom-Free Days (Change From Baseline)|Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Percent Change||Standard Deviation|Mean
164516|NCT00231114|Primary|Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|"Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the “Integrated AQLQ Score."|Baseline, 12 Months|Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.||Units on a scale||Standard Deviation|Mean
164517|NCT00231062|Secondary|Number of Participants Experiencing Relief of Sinus Symptoms|To gain general insight into the ability of balloon catheter sinus ostial dilation to relieve sinus symptoms, scores from the pre-operative SNOT-20 evaluations were compared to scores from the post-procedure SNOT-20 evaluations at 24 weeks following the procedure. The number of participants who showed aggregate symptom relief are recorded here as having been successfully treated.|Week 24|All patients treated per protocol; includes all subjects not lost to follow-up at 24 weeks and who completed symptom questionnaire||Participants|||Number
164518|NCT00231062|Primary|Number of Participants With Adverse Events Following Sinuplasty Procedure|Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).|24 weeks|Analysis per protocol; based on subjects not lost to follow-up at 24 weeks||Participants|||Number
164519|NCT00231062|Primary|Number of Sinuses With Patency of Sinus Ostium After Sinuplasty|Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.|24 weeks|Analysis per Protocol; based on all sinuses of subjects not lost to follow-up at 24 weeks||Sinuses|Participants||Number
164520|NCT00230971|Secondary|Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure|Healthcare resource utilization assessment included days of overall inpatient hospitalization, days of primary inpatient hospitalization, days of Intensive Care Unit (ICU) treatment and days of non-ICU inpatient hospitalization|up to 6 weeks|All patients who received at least 1 dose of study drug.||days||Standard Deviation|Mean
164521|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response was assessed at patient level was the combined responses for all baseline isolates identified in intra-abdominal and blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=No sample for culture, clinical response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=No sample available for culture, clinical response was failure; Superinfection=culture from primary infection site with new isolate not identified at baseline, clinical response was failure.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
164522|NCT00230971|Secondary|Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit|ME population were subjects who were clinically evaluable and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|up to 6 weeks|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
164523|NCT00230971|Primary|Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit|CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.|up to 6 weeks|All patients who received at least 1 dose of study drug who had clinical evidence of a complicated intra-abdominal infection (cIAI) and completed the test-of-cure (TOC) assessment of cure or failure within 8 to 44 days after the last administration of study article. Patients with an indeterminate assessment were excluded.||participants|||Number
164528|NCT00230282|Primary|Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR)|"Response criteria as per the NCI-WG Revised Guidelines for B-CLL~Complete remission:~No lymphadenopathy by physical exam No hepatomegaly or splenomegaly Absence of constitutional symptoms Polymorphonuclear leukocytes > 1,500/uL, Platelets > 100,000/uL, Hemoglobin > 11.0 g/dL Bone marrow aspirate and biopsy normocellular with < 30% lymphocytes Absent lymphoid nodules~Partial remission:~50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value~50% reduction in lymphadenopathy and/or ≥ 50% reduction in the size of the liver and/or spleen AND one or more of the following Polymorphonuclear leukocytes > 1,500/uL or 50% improvement over baseline Platelets > 100,000/uL or 50% improvement over baseline Hemoglobin > 11.0 g/dL or 50% improvement over baseline"|24 weeks|||participants|||Number
164529|NCT00230178|Secondary|Time to Uric Acid Control|Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion.|Day 1 to Day 7|The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug.||Hours||95% Confidence Interval|Median
164530|NCT00230178|Secondary|Plasma Uric Acid|Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values|Day 1 to Day 7|The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC.||mg*h/dL||Standard Deviation|Mean
164531|NCT00230178|Primary|Plasma Uric Acid Responder|Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl.|Day 3 through Day 7|||Participants|||Number
164532|NCT00230126|Primary|1-year Survival Rate||12 months|||percentage of patients|||Number
164533|NCT00230126|Primary|Time to Progression||Every 12 weeks|||months||95% Confidence Interval|Median
164534|NCT00230126|Primary|Disease Control Rate at 12 Weeks|no progression of disease at 12 weeks from starting treatment|12 weeks|||participants|||Number
164535|NCT00230100|Other Pre-specified|Baseline Addiction Severity Index Alcohol Composite Score for Women|The data reflect baseline characteristics of the participants with respect to ASI alcohol composite score. Scores range between 0 and 1. Higher scores reflect higher addiction severity. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status.|Baseline|Only women were included in this analysis.||units on a scale||Standard Error|Mean
164536|NCT00230100|Other Pre-specified|Baseline Drinks Per Drinking Day for Women|The data reflect baseline characteristics of the women participants with respect to the number of drinks per drinking day in the 60 days prior to baseline intake. This was measured using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.||Drinks per drinking day||Standard Error|Mean
164537|NCT00230100|Other Pre-specified|Baseline Substance Use Data for Women|The data reflect baseline characteristics of women participants with respect to (1) days of any substance use (i.e. drugs or alcohol), and (2) the number of drinking days, in the 60 days prior to baseline intake.This data was collected using the Timeline Follow-Back.|Baseline|Only women were included in this analysis.||Days||Standard Error|Mean
164538|NCT00230100|Post-Hoc|Client Satisfaction for Women|"Participant satisfaction with the groups was assessed using the Client Satisfaction Questionnaire (CSQ-8) plus four additional questions about the helpfulness of the therapist, group content, and group composition. Questions were answered on a 4-point scale where 1 reflected negative feelings and 4 reflected positive feelings. Participants' scores are calculated by adding up the numbers assigned to their chosen answers. Therefore, scores can range between 12 and 48, with higher scores reflecting greater satisfaction.~The CSQ was administered at week 3, 6, 9, and 12 while participants were in treatment. Scores represent calculated averages of the group averages for week 3, week 6, week 9, and week 12."|In treatment phase (week 1-12)|Only women were included in this analysis.||units on a scale||Full Range|Mean
164539|NCT00230100|Secondary|Change in Mean Addiction Severity Index Alcohol Composite Score for Women|"This represents the change from baseline in mean composite scores of the Addiction Severity Index (ASI) alcohol section. The ASI was administered at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.~The ASI is a widely employed multidimensional assessment of substance-related problems. Scores range from 0-1 where higher scores reflect higher addiction severity."|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||units on a scale||Standard Error|Mean
164540|NCT00230100|Secondary|Change in Mean Number of Drinks Per Drinking Day for Women|This represents the change from baseline in the mean number of drinks per drinking day for women. The number of drinks per drinking day was measured using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||Drinks per drinking day||Standard Error|Mean
164541|NCT00230100|Primary|Change in Mean Number of Drinking Days for Women|This represents the change from baseline in the mean number of drinking days for women. Number drinking days was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||Drinking days||Standard Error|Mean
164542|NCT00230100|Primary|Change in Mean Days of Any Substance Use for Women|This represents the change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol). Days of substance use was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data.|In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9)|Only women were included in this analysis.||Days of any substance use per month||Standard Error|Mean
164543|NCT00230048|Primary|Treatment Engagement|Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.|3 months|ITT, treating all participants lost to follow up as failures (i.e., not receiving any treatment services)||participants|||Number
164544|NCT00230048|Primary|Number of Participants With Drug Use at 3 Months|The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.|3 months|Intent to treat, treating participants lost to follow-up as positive.||participants|||Number
164545|NCT00230022|Primary|Motivation to Change Substance Use|An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.|One month|A total of 30 participants were included in this pilot trial, based primarily on convenience and timeframe. The primary goal was effect-size estimation, so power was not a primary concern. Last Observation Carried Forward(LOCF) was utilized for 8 participants lost to follow-up.||units on a scale||Standard Deviation|Mean
164546|NCT00230009|Primary|Treatment Engagement|The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).|at 3 month follow-up|||participants|||Number
164547|NCT00230009|Secondary|Depression|Depression was measured by using the Center for Epidemiologic Studies Depression Scale (CES-D) at the 3 month follow-up. CES-D total scores can range from 0 to 60. Scores at 16 or higher indicate clinical significance. Higher scores represent higher risk for depression.|at 3 month follow-up|||units on a scale||Standard Deviation|Mean
164548|NCT00230009|Primary|Child Abuse Potential|Change score was calculated by taking the follow-up scores on the Brief Child Abuse Potential Inventory (BCAP) and subtracting the baseline score. The possible total score for the BCAP ranges from 0 to 24. Therefore, the possible range of scores for the change calculation (reported below) is -24 to +24. Higher scores indicate higher risk at the follow-up visit (worse outcome).|baseline and 3 month follow-up|||units on a scale||Standard Deviation|Mean
164549|NCT00230009|Primary|Drug Use|Drug use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported about marijuana use at the 3 month follow-up. The mean of each the assessment only and intervention group was used. Scores ranged from 0 to 13 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.||units on a scale||Standard Deviation|Mean
164550|NCT00230009|Primary|Alcohol Use|Alcohol use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported at the 3 month follow-up. The mean of each the control and intervention group was used. Frequency of use ranged from 0 to 5 for the follow-up sample. Higher scores mean more frequent use of the substance.|3 month follow-up|A total of 43 participants returned for follow-up and were the only participants analyzed on this outcome.||units on a scale||Standard Deviation|Mean
164551|NCT00229970|Primary|The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)|The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor|baseline over the first 60 minutes|Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)||Liter||95% Confidence Interval|Least Squares Mean
164552|NCT00229957|Secondary|Patient Satisfaction Questionnaire - 18 (Modified)|Patient satisfaction with the care they received. (Score range 0-5)|15 months||||||
164553|NCT00229957|Secondary|Physical Abilities (Strength, Balance)|Grip strength was measured using a JAMAR hand grip dynamometer (in kilograms). The Lower Extremity Function test is a battery of three tests used to measure lower extremity function and balance: a balance test, 8 foot walk test, and repetitive standing from a chair. A performance summary score is created by adding the number of seconds achieved on the balance test, the number of seconds to walk 8 feet and the number of seconds it takes the person to stand up from a chair five times consecutively (no maximum score exists on this measure).|baseline, 15 months||08/2009||||
164554|NCT00229957|Secondary|Self-management and Self-efficacy|Individual's self-reported ability to carry out behaviours to self-manage their health condition, and their confidence level in being able to carry out these behaviours. (Score range 0= not confident at all, 10= totally confident).|baseline, 15 months||08/2009||||
164555|NCT00229957|Secondary|HOME Falls and Accident Screening Tool (FAST)|This is a home assessment of safety hazards for falls present in the individual's home. This tool helps to identify seniors at risk of falls. Score 0-25.|baseline, 15 months||08/2009||||
164556|NCT00229957|Secondary|Falls and Injuries|self-reported number of falls in last 6 months|baseline, 15 months||08/2009||||
164557|NCT00229957|Secondary|Functional Limitations|Late Life Function and Disability Instrument: A measure of functional limitations and disability in older adults.|baseline, 15 months||08/2009||||
164558|NCT00229957|Secondary|Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)|Late Life Function and Disability Instrument: A measure of disability and functional limitations in older adults. (Score range 0-100 with 100 representing better ability and less disability/functional limitation)|baseline, 15 months||08/2009||||
164563|NCT00229723|Secondary|Progression Free Survival|Percentage of participants who are progression free at 2 years (calculated using the Kaplan-Meier method, which allows for censored observations for example those lost to follow-up). A patient is said to have progressed if they have progression of target or non-target lesions or evidence of any new lesions (as defined by RECIST).|Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression (as defined by RECIST)|||Percentage of participants|||Number
164564|NCT00229723|Secondary|Tumour Response (Complete Response + Partial Response)|A patient was deemed to be have a tumour response if the RECIST criteria for complete response or partial response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression|||Participants|||Number
164565|NCT00229723|Secondary|Complete Response|A patient was deemed to be a complete responder if the RECIST criteria for complete response were satisfied at any time during the study.|Assessed at 2 years. Clinical tumour assessments and tumour assessment by CT/MRI were carried out during screening and regularly throughout the study until disease progression.|||Participants|||Number
164566|NCT00229723|Secondary|Local Disease Control Rate at 1 Year|A patient demonstrated local disease control at 1 year if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed after 1 year. Tumour assessments (clinical and by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by RECIST).|||Participants|||Number
164567|NCT00229723|Primary|Local Disease Control Rate at 2 Years|A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.|Assessed at 2 yrs. Tumour assessments (clinical & by CT/MRI) were carried out during screening & regularly throughout the study until disease progression (as defined by Response evaluation criteria in solid tumours (RECIST)).|||Participants|||Number
164568|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 6|Mean change in body weight from baseline at month 6|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||kg||Standard Error|Mean
164569|NCT00229658|Secondary|Change in Body Weight From Baseline at Month 3|Mean change in body weight from baseline at month 3|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||kg||Standard Error|Mean
164570|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 6|Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|6 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||percent||Standard Error|Mean
164571|NCT00229658|Secondary|Change in HbA1c From Baseline at Month 3|Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood.|3 months|Intent-to-Treat, patients who discontinue SYMLIN 7 or more days prior to a site visit are not included in the analyses||percent||Standard Error|Mean
164572|NCT00229658|Secondary|Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Events per patient year|||Number
164573|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Incidence (%)|||Number
164574|NCT00229658|Secondary|The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.~MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH."|0-3 months|Intent-to-Treat||Events per patient year|||Number
164575|NCT00229658|Secondary|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period|MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat.||Incidence (%)|||Number
164576|NCT00229658|Secondary|The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Events per patient year|||Number
164606|NCT00228384|Secondary|Target Vessel Revascularization (TVR)|This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.|3 years|||percentage of participants|||Number
164577|NCT00229658|Secondary|The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period|"The steady state period represents the >3-6 months of pramlintide treatment following the adjustment period.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|>3-6 months|Intent-to-Treat, number analyzed includes patients still enrolled in the study during the steady-state period (3-6 months)||Incidence (%)|||Number
164578|NCT00229658|Primary|Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|"The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment.~PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention."|0-3 months|Intent-to-Treat||Events per patient year|||Number
164579|NCT00229658|Primary|Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period|PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment|0-3 months|Intent-to-Treat||Incidence (%)|||Number
164580|NCT00229619|Secondary|Relapse, Disease Progression, Survival, Change in Transfusion Requirements, Response to Second Cycle of Rituximab and Compare the Efficacy and Safety Profile With a Similar Patient Population Who Are Participating on the Daclizumab Trial||6 months||||||
164581|NCT00229619|Secondary|Response Rates at 3 Months (After the First Dose of Study Med)||3 months||||||
164582|NCT00229619|Secondary|Secondary Endpoints Include Response at 3 Months, Durability of Response, Disease Progression, Survival and the Response to a Second Course of Therapy When Indicated.||3 months||||||
164583|NCT00229619|Primary|Response to Rituximab|"Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.~Primary endpoint will determine immune response by evaluating changes in peripheral blood counts (platelets, absolute neutrophil count, reticulocyte count, hemoglobin) and transfusion requirements at 6 months. The response wil be will be categorized as complete, partial or no response. Subjects will be categorized as complete responders if their blood counts return to normal. Subjects will categorized as partial responders if there is an improvement in 2 or 3 of the depressed baseline blood counts."|6 months|||participants|||Number
164584|NCT00228813|Primary|Incidence of Chronic Graft-versus-host Disease|The number of participants diagnosed with chronic graft-versus-host disease (GVHD).|Duration of Study (Up to two years)|Participants who survived beyond Day 100 post bone marrow transplant.||participants|||Number
164585|NCT00228813|Primary|Incidence of Acute Graft-versus-host Disease|The number of participants diagnosed with new acute graft-versus-host disease (GVHD).|Day 100|Participants who who developed acute GVHD was measured at Day 100 post bone marrow transplant.||participants|||Number
164586|NCT00228813|Primary|Engraftment Rate|The number of participants who received in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donor who reached engraftment by Day 45.|Day 45|||particpants|||Number
164587|NCT00228566|Primary|Number of Responders to the Patient Global Impression of Change (PGI-C) Ratings|A subjective measure (PGI-C rating) of the patient’s global health, ie, a patient’s rating of disease severity, as compared with a pretreatment (baseline) evaluation assessment by the patient using the Patient Global Impression of Severity of illness (PGI-S). Responders at each visit were defined as having at least minimal improvement in the severity of excessive sleepiness as compared with a pretreatment evaluation made using the PGI-S.|Weeks 4, 8, and 12, at 3 month intervals thereafter, and at a Final Visit (or last postbaseline observation). Evaluation continues until the Final Visit, which occurs when the product is commercially available or the marketing application is withdrawn.|||Participants|||Number
164588|NCT00228553|Primary|Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)|An adverse event is any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of a clinical study. Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|End of months 1, 3, 6, 9, and 12 and every 3 months for up to an additional year|Safety Analysis set of 731 total patients: 12 participants (3 female ; 9 male) withdrew after randomization but prior to receiving study drug.||Participants|||Number
164589|NCT00229203|Secondary|Number of Patients With Overall Survival (OS)|Overall Survival (OS): time from the date of first infusion to the date of documented death|Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.||percentage patients|||Number
164590|NCT00229203|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death|Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.|Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)||months||Full Range|Median
164591|NCT00229203|Secondary|Time to Progression (TTP)|Time to Progression (TTP):date of first infusion to the date of documented progressive disease which can be defined as >25 percentage increase in level of serum monoclonal paraprotein.|Every 2 weeks until progression or death due to progression occurs. Median TTP and TTP rates at 3 months and 6 months were assessed.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)||months||Full Range|Median
164592|NCT00229203|Primary|Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response|"Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: >25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.~Treatmen failure: Reappearance of serum or urinary paraprotein"|Every 2 weeks until progression or death occurs.|Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)||percentage patients|||Number
164593|NCT00228943|Primary|Objective Subject Hot Flash Frequency|Mean of the 24 hour monitoring sessions for each patient based on one 24 hour monitoring session after each intervention using an electronic monitor.|One 24 hour monitoring session per week for 8 weeks|Subjects with completed hot flash data during both arms of study.||frequency of hot flashes||Standard Deviation|Mean
164594|NCT00228943|Primary|Serum Tryptophan Levels|Mean serum tryptophan levels (blood draw) at the end of the nadir period.|baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours|The number of subjects with complete serum data for both arms of the study were analyzed.||nmol/ml||Standard Deviation|Mean
164595|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment.||percentage of participants|||Number
164596|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.|2 years|The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment.||percentage of participants|||Number
164597|NCT00228384|Secondary|Occurrence of Stent Fracture|The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.|1 year|The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment.||percentage of particpants|||Number
164598|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0.|3 years|||percentage of subjects||95% Confidence Interval|Number
164599|NCT00228384|Secondary|Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)|The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5.|3 years|||percentage of subjects||95% Confidence Interval|Number
164600|NCT00228384|Secondary|Change in Ankle-Brachial Index (ABI)|"This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.~A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal.~An outcome of a higher mean ABI is considered a success."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded.||ABI Value||Standard Deviation|Mean
164601|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.~The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.||Score||Standard Deviation|Mean
164602|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)|"The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.~The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline."|3 years|The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment.||Score||Standard Deviation|Mean
164603|NCT00228384|Secondary|Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)|"The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire.~Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline."|3 years|Number of subjects that returned for 3yr follow-up appointment and completed the ICQ.||Score||Standard Deviation|Mean
164604|NCT00228384|Secondary|Improvement in Rutherford Classification (Clinical Success)|"The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|3 years|The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data.||percentage of participants|||Number
164607|NCT00228384|Secondary|Technical Success at Initial Procedure|"Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow.~The results show the percentage of study subjects that had technical success."|Time of implant procedure|The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success.||percentage of subjects|||Number
164608|NCT00228384|Secondary|Secondary Patency|Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.|3 years|||percentage of subjects||95% Confidence Interval|Number
164609|NCT00228384|Secondary|Primary Assisted Patency|Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion.|3 years|||percentage of subjects||95% Confidence Interval|Number
164610|NCT00228384|Primary|Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)|Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.|30 days|||percentage of subjects|||Number
164611|NCT00228384|Primary|Efficacy: Primary Patency at Three Years|"Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention.~The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years)."|3 years|||percentage of subjects||95% Confidence Interval|Number
164612|NCT00227994|Secondary|Medication Tolerability|Withdrawal due to side effects|Measured throughout the study|||participants|||Number
164613|NCT00227994|Primary|Physical Function (Measured by the FIM-motor)|Score on Functional Independence Measure (FIM) motor score, where 7 indicates total assistance/complete dependence and 91 is complete independence|Measured at weeks 0 and 12|||units on a scale||Standard Deviation|Mean
164614|NCT00227903|Other Pre-specified|Attendance of Treatment Outside the Study|The number of patients who attended outside treatment in the 30 days prior to each assessment.|30 days prior to assessment|all randomized participants with data availabe at time frames||participants|||Number
164615|NCT00227903|Other Pre-specified|Adequacy of Received Services|Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.|After prenatal care initiation|All randomized participants, 6 women had unkown attendance.||participants|||Number
164616|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.||proportion of participants|||Number
164617|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.||proportion of participants|||Number
164618|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.||proportion of participants|||Number
164619|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.||proportion of participants|||Number
164620|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.||proportion of participants|||Number
164621|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.||proportion of participants|||Number
164622|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.||proportion of participants|||Number
164623|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.||proportion of participants|||Number
164624|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.||proportion of participants|||Number
164625|NCT00227903|Secondary|Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis of drug abuse or dependence.||proportion of participants|||Number
164626|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.||proportion of participants|||Number
164627|NCT00227903|Secondary|Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug abuse or dependence.||proportion of participants|||Number
164628|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine, or opioids.|Delivery to 3 months post-delivery|All randomized participants with both self-report and urine data available during the time frame.||proportion of participants|||Number
164629|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.||percentage of days||Standard Deviation|Mean
164630|NCT00227903|Primary|Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants with a baseline diagnosis for drug abuse or dependence.||percentage of days||Standard Deviation|Mean
164631|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||Delivery to 3 months post-delivery|All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.||percentage of days||Standard Deviation|Mean
164632|NCT00227903|Primary|Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|All randomized participants without a baseline diagnosis of drug use or dependence.||percentage of days||Standard Deviation|Mean
164633|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine|Based on urine tests for marijuana, cocaine or opioids.|intake to delivery, an average of 21 weeks|All randomized participants with both self-report and urine data available.||proportion of participants|||Number
164634|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs According to Urine|Based on urine tests for marijuana, cocaine, or opioids|Delivery to 3 months post-delivery|All randomized participants for whom urine data was available during the time frame.||proportion of participants|||Number
164635|NCT00227903|Secondary|Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine||intake to delivery, an average of 21 weeks|All randomized participants for whom urine test data was available.||proportion of participants|||Number
164636|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||Delivery to 3 months post-delivery|All randomized participants with data available from the time frame.||proportion of participants|||Number
164637|NCT00227903|Secondary|Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report||intake to delivery, an average of 21 weeks|All randomized participants||proportion of participants|||Number
164638|NCT00227903|Secondary|Incidence of Low Birth Weight||At delivery|Only singleton live births, which occurred in 163 subjects, were analyzed. Three of the women in the MI-CBT group had an infant of unknown birth weight, and were not included in analysis.||low weight births|||Number
164639|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||delivery to 3 months post-delivery|all randomized participants with data from delivery and 3 months post-delivery||percentage of days||Standard Deviation|Mean
164640|NCT00227903|Secondary|Incidence of Preterm Births||At delivery|A singleton live birth occurred in 163 subjects, and 5 had twins. Data was collected from the 84 women of the Brief Advice category and the 79 women of the MI-CBT category who had singleton live births.||preterm births|||Number
164641|NCT00227903|Primary|Percentage of Days Used Drugs or Alcohol||intake to delivery, an average of 21 weeks|all randomized participants||percentage of days||Standard Deviation|Mean
164642|NCT00227760|Secondary|Progression Free Survival||Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years|Total patients||months||95% Confidence Interval|Median
164643|NCT00227760|Primary|Objective Response, Evaluated Using RECIST|Partial response as assessed by RECIST criteria|4 weeks|Evaluable patients||participants|||Number
164644|NCT00227760|Primary|Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)|Stable disease for a clinical benefit rate, evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)|4 weeks|Evaluable patients||particip[ants|||Number
164645|NCT00227721|Secondary|Progression-free Survival||Every two cycles||||||
164646|NCT00227721|Primary|Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer.||Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first).|||percentage of participants with CR or PR||90% Confidence Interval|Number
164665|NCT00227305|Primary|Change From Baseline in Supine Pulse|Change from OL baseline to week 26 in supine pulse (bpm)|OL baseline to week 26|Number of participants with OL baseline and post treatment visits||bpm||Standard Deviation|Mean
164666|NCT00227305|Primary|Change From Baseline in Weight|Number with 7% or more increase (without adjustment for normal growth)|26 weeks of treatment|Number of participants is based on patients with both baseline values and post-baseline values.||Participants|||Number
167215|NCT00168844|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^12/Litre (L)||Standard Deviation|Mean
164647|NCT00227591|Primary|Overall Response Rate|"Response was evaluated for Anemia and Spleen:~Major anemia response: hemoglobin increase to within normal limits in the absence of transfusion. Minor anemia response: hemoglobin improvement of at least 2 grams per deciliter independent of transfusion support, or achievement of transfusion independence in transfusion-dependent patients. Major spleen response: normalization of spleen size to the range of 12-14 centimeters by ultrasound. Minor spleen response: a 50% or more decrease in excess spleen size by ultrasound. Complete remission (CR): complete resolution of disease-related symptoms, splenomegaly, normalization of peripheral blood count, white cell differential and smear, and normalization of bone marrow histology. Partial remission (PR): a major or minor response in anemia or splenomegaly. Overall Response (OR)=CR + PR, assessed among eligible, treated patients."|Assessed at the end of cycle 3|6 ineligible patients were excluded from the analysis.||Proportion of participants||95% Confidence Interval|Number
164648|NCT00227370|Secondary|Ganciclovir Resistance|UL97 genotyping was done on all positive samples for CMV DNA at 1000 copies/mL, with resistance defined by the presence of 1 or more mutations shown by marker transfer to confer phenotypic ganciclovir resistance|over the course of 300 days post randomization|intention to treat||participants|||Number
164649|NCT00227370|Secondary|Severity of Viremia|upon diagnosis of cmv disease, the number of CMV DNA copies/mL as measured by PCR|over the course of 300 days after randomization|intention to treat||CMV copies/mL||Inter-Quartile Range|Median
164650|NCT00227370|Secondary|Non-CMV Infection|non cmv opportunistic infections|over the course of 300 days after randomization|intention to treat||participants|||Number
164651|NCT00227370|Secondary|Biopsy Proven Acute Lung Rejection||over the course of 300 days of randomization|intention to treat||participants|||Number
164652|NCT00227370|Secondary|Any CMV Infection|Inclusive of CMV syndrome, disease, or infection not meeting primary end point.|over the course of 300 days post randomization|intention to treat||participants|||Number
164653|NCT00227370|Primary|Incidence of CMV Syndrome|CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)|over the course of 300 days after randomization|intention to treat analysis||participants|||Number
164654|NCT00227370|Primary|Incidence of CMV End Organ Disease|The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.|over the course of 300 days after randomization|Intention to treat analysis was conducted.||participants|||Number
164655|NCT00227344|Secondary|Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor||at each patients last follow-up visit|Intention to Treat (ITT)analysis of sinus rhythm was performed for subjects with available Holter Monitor data.||percentage of participants|||Number
164656|NCT00227344|Secondary|Health-economics Parameters (Days of Hospitalization)||at 26 months and at each patients last follow-up visit|Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.|||||
164657|NCT00227344|Secondary|Quality of Life||at 14, 26 and 38 months|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."|||||
164658|NCT00227344|Secondary|Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs||at 26 months and at each patients last follow-up visit|"Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The 0 below represents not available."|||||
164659|NCT00227344|Secondary|Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase||day 61 through 790|"Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data. The upper bound of the confidence interval for the drug treatment group could not be calculated because of the high censoring rate. Therefore, NA is more appropriate in place of the maximum duration of follow-up (790.0) as the upper bound."||days||95% Confidence Interval|Median
164660|NCT00227344|Secondary|Percentage of Procedural Success|"Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following:~“Has a validation of the lesions been performed by taking 3 points inside each circular lesion?”~“If YES to #1, did you observe that none of them exceed 0.1 mV?”~“Did you observe any adverse event during the procedure?”~If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success."|The day of the procedure|"Procedural success was only calculated for the catheter ablation group. Intention to Treat (ITT) analysis of procedural success for the catheter ablation group was performed using available data. The 0 below the Antiarrhythmic Drug treatment group represents not available."||percentage of participants|||Number
164661|NCT00227344|Secondary|Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)||within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.||percentage of participants|||Number
164662|NCT00227344|Primary|Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).|Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.|within first 24 months after a 2-month run-in phase|Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.||percentage of participants|||Number
164663|NCT00227305|Primary|Change From OL Baseline in Supine Diastolic BP.|Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits||mmHg||Standard Deviation|Mean
164664|NCT00227305|Primary|Change From OL Baseline in Supine Systolic BP.|Changes from OL baseline to the final visits in Supine systolic BP (mmHg)|OL baseline to Week 26|Number of participants with OL baseline and post treatment visits||mmHg||Standard Deviation|Mean
164667|NCT00227305|Primary|Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score|"Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.~Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score."|26 weeks of treatment|Number of patients with BARS score at OL baseline and week 26.||Participants|||Number
164668|NCT00227305|Primary|Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score|"Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).~Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score."|OL baseline to week 26|Number of patients with SAS score at OL baseline and week 26.||Participants|||Number
164669|NCT00227305|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS) Score|Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).|OL Baseline to Week 26|Number of patients with CGAS score at OL baseline and week 26.||units on a scale||Standard Deviation|Mean
164670|NCT00227305|Secondary|Changes in Tanner Stage|"Category shift in Tanner stage. Number of subjects who experienced the change is presented.~Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger."|Change from OL baseline to week 26 in the Tanner stage|Number of patients with Tanner stagging data at OL baseline and week 26 (final visit)||Participants|||Number
164671|NCT00227305|Primary|Changes in Laboratory Test Results (Prolactin)|"Clinical important shift to high prolactin from open-label (OL) baseline to week 26.~High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male."|Duration of study participation|||Participants|||Number
164672|NCT00227305|Primary|Number of Patients Withdrawn Due to AEs.|Number of subjects who withdrew from the study due to AEs.|during 26 weeks of treatment|||Participants|||Number
164673|NCT00227305|Primary|Incidence and Nature of Adverse Events (AEs)|Number of participants that had AE which occurred from first dose date to last dose date + 30 days.|from open label to week 26+ 30 days|||Participants|||Number
164674|NCT00227266|Secondary|Max CMAP Area (Median)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mVms||Full Range|Median
164675|NCT00227266|Secondary|Max CMAP Area (Mean)|The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mVms||Standard Deviation|Mean
164676|NCT00227266|Secondary|DEXA||0, 6mo, 12mo||||||
164677|NCT00227266|Primary|Modified Hammersmith Change From Baseline to 6 Months|Comparison of Modified Hammersmith Change from baseline to 6 months. Scores range from 0 to 40. A higher score indicates a better outcome. This scale is used to assess gross motor abilities of non-ambulant children with SMA in multiple research trials as well as in clinical settings.|0 months, 6 months|Analysis only pertains to cohort 1a and 1b.||Score||Standard Deviation|Mean
164678|NCT00227266|Post-Hoc|Modified Hammersmith Extend Baseline|"Baseline Modified Hammersmith Extend testing. The baseline test is the score they receive during their screening visits. This scale ranges from 0 to 56. A higher score indicates a better outcome.~This scale is used to assess gross motor abilities of children with SMA in multiple research trials as well as in clinical settings."|1 month prior to enrollment, at enrollment (0 months)|Analysis was determined per protocol||Score||Full Range|Mean
164679|NCT00227266|Secondary|Nutritional Status||-4 wks, 0, 3mo, 6mo, 12mo||||||
164680|NCT00227266|Secondary|Growth and Vital Sign Parameters||-4 wks, 0, 3mo, 6mo, 12mo||||||
164681|NCT00227266|Secondary|Ulnar MUNE||-4 wks, 0, 3 mo, 6 mo, 12 mo||||||
164682|NCT00227266|Secondary|Max CMAP Amplitude Median|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mV||Full Range|Median
164683|NCT00227266|Secondary|Max CMAP Amplitude (Mean)|The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed.|1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)|||mV||Standard Deviation|Mean
164684|NCT00227266|Secondary|Peds QL™ Assessment: Parental Version (All), Child Versions (> 5yrs)||-4wks, 0, 3mo, 6mo, 12mo||||||
164685|NCT00227266|Secondary|Quantitative Assessment of SMN mRNA From Blood Samples||-4wks or 0, 3 mo, 6 mo, 12 mo||||||
164686|NCT00227266|Primary|Efficacy, Measured Through Motor Function Assessments||-4wks, 0, 3 mo, 6 mo, 12 mo||||||
164687|NCT00227266|Primary|Safety Labs|Participants will have labs drawn regularly to maintain appropriate dosing and monitor liver function|-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs||||||
164688|NCT00226811|Primary|Objective Response (Complete Response (CR) or Partial Response (PR))|Number of patients with Objective Response (OR): confirmed CR or confirmed PR according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population||participants|||Number
164689|NCT00226811|Secondary|Overall Survival|Time from the date of first dose of study medication to the date of death due to any cause. OS was calculated as (date of death minus the date of first dose date plus 1) divided by 7.|From start of study treatment until death|ITT population||weeks||95% Confidence Interval|Median
164690|NCT00226811|Secondary|Time to Tumor Progression (TTP)|Time from the start of study treatment to the first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|ITT population||weeks||95% Confidence Interval|Median
164691|NCT00226811|Secondary|Progression-Free Survival|Time from start of study treatment to first documentation of objective tumor progression, or to death due to any cause. PFS was calculated as (first event date minus the date of first dose plus 1) divided by 7.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death|ITT population||weeks||95% Confidence Interval|Median
164692|NCT00226811|Secondary|Duration of Response (CR or PR)|Time from the first documentation of confirmed objective response (CR or PR) to the first documentation of disease progression or to death due to any cause. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer|ITT population||weeks||Full Range|Mean
164693|NCT00226811|Secondary|Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks|Number of patients with Clinical Benefit Response: confirmed CR, confirmed PR or stable disease (SD) for at least 24 weeks on study according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progessive disease (PD) taking as a reference the smallest sum of the longest dimensions since the treatment started.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study|ITT population||participants|||Number
164694|NCT00226811|Primary|Best Overall Response|Number of patients with best overall response = complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter|Intent-to-treat (ITT) population includes all patients enrolled in the study that received at least 1 dose of study medication.||participants|||Number
164695|NCT00226655|Primary|Long Term Safety and Tolerability of hCRF|Number of patients reporting adverse events|Prospective|Intent to Treat||Participants|||Number
164696|NCT00226590|Secondary|Treatment Completion|The number of participants who completed all treatment on schedule without dose reductions or delays.|Ranging from 2 weeks up to 4 years, 9 months|per protocol||participants|||Number
164697|NCT00226590|Secondary|Overall Survival|To determine median Overall Survival rate|Ranging from 2 weeks up to 4 years, 9 months|||months||95% Confidence Interval|Median
164698|NCT00226590|Secondary|Progression Free Survival|To determine median Progression Free Survival rate. Progression-free survival (PFS) is defined as the interval between the date of the first chemotherapy administration and the date of objective progression or death. Progression was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|per protocol||months||95% Confidence Interval|Median
164699|NCT00226590|Primary|Number of Participants Whose Response Allowed Them to Proceed to Chemoradiation|Response Rates - Complete Response (CR) + Partial Response (PR): We determined the number of participants whose response (both CT and PET assessment) to two cycles of induction chemotherapy with gemcitabine and carboplatin allowed them to proceed to chemoradiation. Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.|Ranging from 2 weeks up to 4 years, 9 months|Per Protocol||participants|||Number
164700|NCT00226577|Secondary|Toxicity|Number of participants with toxicity ≥ Grade 3 after gemcitabine plus pemetrexed induction chemotherapy.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A total of 52 eligible patients, 26 men and 26 women, between the ages of 41 and 83 years received at least one dose of chemotherapy. Only 49 patients were evaluable because 3 patients had only the first cycle.||participants|||Number
164701|NCT00226577|Secondary|Survival - Overall|Median range of number of participants with Overall Survival. Overall survival (OS) will be defined as the period of time from the first day of drug treatment to the date of death of the patient. Patients taken off study will be followed quarterly until death for survival data.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|All patients||months||Full Range|Median
164702|NCT00226577|Secondary|Survival - Disease Free|Disease-free survival (DFS) is defined as the period of time from surgery to the time when disease recurrence is clearly documented. A histologic confirmation is required in equivalent cases.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|40 patients with complete tumor resection.||months||Full Range|Median
164703|NCT00226577|Secondary|Disease Response - Pathologic|Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen, which consists of equal to or more than 95% fibrosis and necrosis.|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A pathologic response evaluation was possible in 43 of 52 patients.||participants|||Number
164738|NCT00224874|Secondary|Proportion of Treatment Failure||Measured at Day 56|||percentage of participants||95% Confidence Interval|Number
164704|NCT00226577|Primary|Disease Response - Radiographic|"Number of participants with partial or Complete Response. Complete response (CR) is defined as the total disappearance of all malignant and evaluable clinical evidence of cancer without the development of any new malignant lesions documented on the post chemotherapy chest CT and PET scan.~Partial response (PR) (measurable disease only): When compared with pre-treatment measurements, a reduction of >30% in the sum of the largest diameters of all measurable lesions and absence of new lesions."|06/20/2008 Index date for patients enrolled between 04/2004 and 04/2006|A radiographic response evaluation was possible in 49 of 52 patients.||participants|||Number
164705|NCT00225784|Secondary|Pattern of Failure After Therapy|Local recurrence, distant recurrence, or both.|Five years post treatment|All participants who completed treatment and underwent resection||participants|||Number
164706|NCT00225784|Secondary|Overall Length of Survival After Therapy|Length of survival after therapy in all participants enrolled.|Five years post treatment|All participants enrolled regardless of evaluability for primary outcome measure.||months||Full Range|Median
164707|NCT00225784|Secondary|Disease-Free Survival After Therapy|Time to disease progression after therapy.|Five years post treatment|All evaluable participants who completed treatment, and had confirmed progression of disease.||months||Full Range|Median
164708|NCT00225784|Secondary|Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.|Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.|One month post-therapy|All EGFR (-) subjects who completed therapy were evaluated.||percent|||Number
164709|NCT00225784|Secondary|Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy|Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).|1 month after completion of treatment|Surviving participants who completed therapy and were determined to be resectable.||participants|||Number
164710|NCT00225784|Secondary|Number of Participants Assessed for Adverse Events|Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0|Participants were followed during treatment and for 30 days after completion of treatment|All participants were evaluated for toxicity.||participants|||Number
164711|NCT00225784|Primary|Objective Response of Tumor by RECIST 1.0 Criteria|Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.|one month post-therapy|Completion of treatment||participants|||Number
164712|NCT00225732|Primary|Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery|Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery|24 Hours|||milligrams||Standard Error|Least Squares Mean
164713|NCT00225498|Primary|Working Memory|"California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome.~The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner."|3 months|The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.||units on a scale||Standard Deviation|Mean
164714|NCT00225277|Other Pre-specified|Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee|The incidence of cardiovascular events and composite endpoints occurring within 30 days of last dose as adjudicated by the Clinical Endpoint Committee. Abbreviations: PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure.|Up to 72 weeks|Safety Population||Number of Events|||Number
164715|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint C cardiovascular events is being reported instead of time to first occurrence. Endpoint C conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.||participants|||Number
164716|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint B cardiovascular events is being reported instead of time to first occurrence. Endpoint B conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.||Participants|||Number
164717|NCT00225277|Secondary|Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events|Due to low event rates, number of subjects experiencing any of the composite endpoint A cardiovascular events is being reported instead of time to first occurrence. Endpoint A conditions listed in Limitations and Caveats section.|Up to 72 weeks|Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.||Participants|||Number
164756|NCT00224107|Secondary|Maximum Urine Flow Rate (Qmax)|Change from baseline in maximum urine flow rate (Qmax)at Week 12|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||mL/sec||Standard Deviation|Mean
164718|NCT00225277|Secondary|Nominal Change From Baseline in Normalized Total Atheroma Volume|The nominal change in normalized total atheroma volume as measured by the average of plaque areas for all slices of anatomically comparable segments of the target coronary artery multiplied by the mean number of matched slices in the population. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.||Percent volume||Standard Error|Least Squares Mean
164719|NCT00225277|Primary|Nominal Change From Baseline in Percent Atheroma Volume|The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.|Baseline and Final Visit (up to 72 weeks)|N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.||Percent volume||Standard Error|Least Squares Mean
164720|NCT00225251|Secondary|Global Assessment of Functioning Scale (GAFS)|A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)|10 weeks|||units on a scale||Standard Deviation|Mean
164721|NCT00225251|Secondary|Clinical Global Improvement (CGI)|A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)|10 weeks|||units on a scale||Standard Deviation|Mean
164722|NCT00225251|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|10 weeks|||units on a scale||Standard Deviation|Mean
164723|NCT00225251|Secondary|Cornell Dysthymia Rating Scale (CDRS)|A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression|10 weeks|||units on a scale||Standard Deviation|Mean
164724|NCT00225251|Primary|Hamilton Depression Rating Scale, 24 Items (HDRS)|"Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.~This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)"|10 weeks|||units on a scale||Standard Deviation|Mean
164725|NCT00225212|Secondary|Overall Survival (OS)||24 months|||percentage of subjects remaining alive||95% Confidence Interval|Number
164726|NCT00225212|Primary|Event-free Survival (EFS)|"Events for EFS were defined as the earlier of post-ASCT relapse or death."|24 months|||percentage of not experiencing EFS event||95% Confidence Interval|Number
164727|NCT00225147|Secondary|Time to Minimal Symptoms|"The time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale (VAS) score. Symptoms were said to be minimal when the VAS score at all locations was below 20 mm. Assessment timepoints were: baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to minimal symtoms has been calculated by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."||minutes||Full Range|Median
164728|NCT00225147|Primary|Time to Beginning of Relief of Symptoms|"The time to beginning of relief of symptoms at the location that showed the first visual analogue scale (VAS) score decrease of at least 20 mm from baseline score with persistence to the next timepoint, assessment timepoints were taken on pre-scheduled time-points after study drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to beginning of relief has been calculated as median time, by using the exact timepoints on which each assessment was performed."|up to 48 hours after study drug administration|"The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration."||minutes||Full Range|Median
164729|NCT00225017|Secondary|Changes in LDL Particle Number From Baseline to Week 24|Change in LDL particle number|Baseline to 24 weeks|||nmol/l||Inter-Quartile Range|Median
164730|NCT00225017|Secondary|Change in Total Cholesterol Levels From Baseline to Week 24|Total cholesterol level changes within and between arms|Baseline to 24 weeks|||mg/dL||Inter-Quartile Range|Median
164731|NCT00225017|Primary|Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24|Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen|Baseline to week 24|||percentage change||Inter-Quartile Range|Median
164732|NCT00224874|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||Measured at 9 months|No data collected|||||
164733|NCT00224874|Secondary|Cumulative Incidence of Systemic Infections||Measured at Day 270|||percentage of participants||95% Confidence Interval|Number
164734|NCT00224874|Secondary|Number of Patients Surviving at 6 and 9 Months Post Randomization||Measured at 6 and 9 months|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
164735|NCT00224874|Secondary|Number of Patients With Chronic Graft-versus-host Disease (GVHD)|Number of patients with limited and extensive chronic GVHD at 9 months|Measured at 9 months|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
164736|NCT00224874|Secondary|Number of Patients Discontinuing Immune Suppression Without Flare|Immunosuppression discontinuation was defined as the discontinuation of corticosteroids and all additional immunosuppressives, except cyclosporine or tacrolimus, for treatment of acute GVHD without subsequent flare by Day 90 post-initiation of therapy and later by discontinuation of all immunosuppressive medications, including cyclosporine or tacrolimus.|Measured at Days 90, 180, and 270 post-treatment|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
164737|NCT00224874|Secondary|Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90|Flares were defined as any increase in symptoms of or therapy for acute GVHD after an initial response (i.e., progression from an earlier CR or PR).|Measured at Day 90|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
164739|NCT00224874|Secondary|Number of Partial Response (PR), Mixed Response (MR), and Progression|Partial response, mixed response, and progression at Day 28 after randomization. Partial response was defined as improvement in one or more organs involved with Graft-Versus-Host Disease (GVHD) symptoms without progression in others. Mixed response was defined as improvement in one or more organs with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ. Progression was defined as deterioration in at least one organ without any improvement in others.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
164740|NCT00224874|Primary|Number of Complete Response (CR) at Day 28 of Therapy|Complete response at day 28 after randomization. CR was defined as resolution of all signs and symptoms of Graft-Versus-Host Disease (GVHD) in all evaluable organs in comparison to Day 1 scoring.|Measured at Day 28|All patients randomized were included in the analysis on an intent-to-treat basis||participants|||Number
164741|NCT00224770|Primary|Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180|Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead|180 days from randomization|||percentage of participants||90% Confidence Interval|Number
164742|NCT00224770|Secondary|Post-operative Clot Size Reduction|The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients.|Time from post-operation until end of treatment, up to 10 days|Analysis population only includes surgical patients.||percentage of blood clot resolved||Inter-Quartile Range|Median
164743|NCT00224770|Secondary|Clot Size Reduction by End of Treatment|The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan.|Time from randomization until end of treatment, up to 10 days|||percentage of blood clot resolved||Inter-Quartile Range|Median
164744|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 365|Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|365 days from randomization|||units on a scale||Inter-Quartile Range|Median
164745|NCT00224770|Secondary|Ordinal Modified Rankin Scale (mRS) at Day 180|Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.|180 days from randomization|||units on a scale||Inter-Quartile Range|Median
164746|NCT00224770|Primary|Safety Outcome Number 4: Rate of Symptomatic Rebleeding|The difference in the rate of symptomatic rebleeding 72 hours post last dose.|72 hours post last dose|||percentage of participants||90% Confidence Interval|Number
164747|NCT00224770|Primary|Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis|Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.|30 days from randomization|||percentage of participants||90% Confidence Interval|Number
164748|NCT00224770|Primary|Safety Outcome Number 2: Rate of Procedure-related Mortality|Percentage of participants who died during the first 7 days after randomization.|7 days from randomization|||percentage of participants||90% Confidence Interval|Number
164749|NCT00224770|Primary|Safety Outcome Number 1: Rate of Mortality|Percentage of participants who died during the first 30 days after randomization.|30 days from randomization|||percentage of participants||90% Confidence Interval|Number
164750|NCT00224289|Primary|Post-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|8 Weeks|||mm Hg||Standard Deviation|Mean
164751|NCT00224289|Primary|Pre-Treatment IOP (Intraocular Pressure)|Subjects applied topical latanoprost at bedtime for 8 weeks|At baseline (before treatment)|||mm Hg||Standard Deviation|Mean
164752|NCT00224133|Secondary|International Prostate Symptom Score (IPSS)|The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.|9 months||03/2010||||
164753|NCT00224133|Primary|Adverse Events|All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.|9 months|Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.||participants|||Number
164754|NCT00224120|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks||Baseline and 12 weeks|||mL/min||Standard Deviation|Mean
164755|NCT00224120|Primary|Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms|Baseline and 12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||Units on a scale||Standard Deviation|Mean
164829|NCT00220727|Secondary|Number of Subjects With Infusion Related Adverse Events||48 hours after treatment|||participants|||Number
164757|NCT00224107|Primary|International Prostate Symptom Score (IPSS)|Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).||Units on a 0 to 35 scale||Standard Deviation|Mean
164758|NCT00224055|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||ng/mL||Standard Deviation|Mean
164759|NCT00224055|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||g/dL||Standard Deviation|Mean
164760|NCT00224042|Secondary|Change in Serum Ferritin|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||ng/mL||Standard Deviation|Mean
164761|NCT00224042|Primary|Change in Hemoglobin (Hgb)|Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.|Baseline to 10 weeks|Modified ITT with LOCF imputation||g/dL||Standard Deviation|Mean
164762|NCT00224042|Secondary|Baseline Serum Ferritin Concentration||Baseline|||ng/mL||Standard Deviation|Mean
164763|NCT00224042|Primary|Baseline Hemoglobin Concentration||Baseline|||g/dL||Standard Deviation|Mean
164764|NCT00224029|Secondary|Urinary Leakage and Catheterization Data||8 weeks||||||
164765|NCT00224029|Secondary|Urodynamic Measurements||8 weeks||||||
164766|NCT00224029|Secondary|Patch Adhesion||8 weeks||||||
164767|NCT00224029|Primary|Average Number of Catheterizations Without Leaking Per Day|Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.|8 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF.||Number of Dry Catheterizations per Day||Standard Deviation|Mean
164768|NCT00224016|Secondary|Urine Volume After First Awakening|Change from baseline in average volume of urine collected after first morning awakening|14 weeks||||||
164769|NCT00224016|Secondary|Catheterizations Without Leakage|Percentage of catherizations without leakage|14 weeks|mITT, LOCF||% of participants||Standard Deviation|Mean
164770|NCT00224016|Primary|Average Catheterization Urine Volume|Change from baseline in average volume of urine collected by catheterization|14 weeks|Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation||mL||Standard Deviation|Mean
164771|NCT00224003|Primary|Transferrin Saturation|Change from baseline to 2 weeks after last dose|14 weeks|Per protocol (completer) population||%||Standard Deviation|Mean
164772|NCT00224003|Secondary|Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.||14 weeks||||||
164773|NCT00224003|Primary|Serum Ferritin|Change from baseline to 2 weeks after last Fe dose|14 weeks|Per protocol (completer) population||ng/mL||Standard Deviation|Mean
164774|NCT00223977|Secondary|Responders by Treatment Group|Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.|Baseline to 5 weeks and 9 weeks|||participants|||Number
164775|NCT00223977|Secondary|Change From Baseline in Serum Ferritin.|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|||ng/mL||Standard Deviation|Mean
164776|NCT00223977|Secondary|Change From Baseline in Transferrin Saturation (TSAT).|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|||percent||Standard Deviation|Mean
164777|NCT00223977|Secondary|Change From Baseline in Hematocrit (Hct)|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|||percent||Standard Deviation|Mean
164778|NCT00223977|Primary|Hemoglobin|Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection|Baseline to 5 weeks and 9 weeks|modified intent to treat (mITT) with last observation carried forward (LOCF) imputation||ng/mL||Standard Deviation|Mean
164779|NCT00223821|Secondary|Change in Incontinent Episodes at 12-month Follow-up|Percent change from baseline in weekly frequency of incontinent episodes at 12-months post-treatment, derived from baseline and 12-month seven-day bladder diaries|Baseline and 12 months post-treatment|Intention to treat||percent change||Standard Deviation|Mean
164780|NCT00223821|Primary|Change in Incontinent Episodes Immediately Post-treatment|Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.|Baseline and immediately post-treatment - week 8|Intention to treat||percentage change||Standard Deviation|Mean
164781|NCT00223808|Secondary|Change in FIM Score at 6-months|Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63|Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.||units on a scale||Standard Error|Mean
164782|NCT00223808|Secondary|Change in FIM Score Immediately Following Study Intervention.|Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.|After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.|||units on a scale||Standard Error|Mean
164830|NCT00220727|Primary|Free Hemoglobin|Free hemoglobin as a measure to assess hemolysis.|24 hours after treatment|||g/dL||Standard Deviation|Mean
164783|NCT00223808|Primary|Fugl-Meyer Score Change at 6 Months|Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.|FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.|A total of 37 subjects returned for the 6-month follow-up evaluations.||units on a scale||Standard Error|Mean
164784|NCT00223808|Primary|Fugl-Meyer Score Change Immediately Following Study Intervention.|Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.|After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.|||units on a scale||Standard Error|Mean
164785|NCT00223795|Primary|Peak Vertical Force on Affected Limb|An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).|Baseline and end of first intervention period (2 months)|||N/kg||Standard Deviation|Mean
164786|NCT00223704|Secondary|Fibrinolytic Response as Measured by D-dimer|D-dimer concentrations were measured at baseline, 30min and 60min of bypass, post-bypass and postoperative day 1|Patients were followed from the start of surgery until postoperative day 1|||ng/ml||Standard Error|Mean
164787|NCT00223704|Secondary|Inflammatory Response as Measured by Interleukin-6|Interleukin-6 was measured at baseline, post-bypass and on postoperative day 1 and 2.|Patients were followed from the start of surgery until postoperative day 2|||pg/ml||Standard Error|Mean
164788|NCT00223704|Secondary|Units of Plasma Transfused During Hospitalization|Units of plasma transfused|Patients were followed for the duration of hospital stay, an average of 6 days|||units||Standard Error|Mean
164789|NCT00223704|Secondary|Units of Packed Red Blood Cells Transfused During Hospitalization|Units of Packed Red Blood Cells Transfused|Patients were followed for the duration of hospital stay, an average of 6 days|||units||Standard Error|Mean
164790|NCT00223704|Primary|Allogenic Blood Product Transfusion Risk|Blood product transfusion during hospitalization that included packed red blood cells, plasma, platelets and cryoprecipitate.|Patients were followed for the duration of hospital stay, an average of 6 days|||percentage of participants|||Number
164791|NCT00223652|Secondary|Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up|"Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE).~A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up."|6-month follow up at week 44 post treatment|||participants|||Number
164792|NCT00223652|Secondary|Maintenance of Treatment Effect|"6-month post treatment follow-up on outcome measure of the Patient Health Questionnaire-9 (PHQ-9).~Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9.~PHQ-9 score ranges from 0-27, higher values indicate more severe depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively."|6-month post treatment follow-up|||units on a scale||Standard Deviation|Mean
164793|NCT00223652|Primary|Number of Participants Meeting Criteria for Major Depressive Disorder|Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder [PTSD] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.|Baseline to week 12, and week 20|||participants|||Number
164794|NCT00223652|Primary|Change in Severity of Depression Using the Patient Health Questionnaire-9|"Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9).~Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.~PHQ-9 score ranges from 0-27, higher values indicate more severe depression."|Baseline, Week 12, Week 20|||units on a scale||Standard Deviation|Mean
164795|NCT00223652|Secondary|Maintenance of Treatment Effect|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(post treatment), and 6-month follow-up using the Ham-D.Data was analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.~Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|6 month follow-up (week 44)|||units on a scale||Standard Deviation|Mean
164831|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Week 12|||units on a scale||Standard Deviation|Mean
164796|NCT00223652|Primary|Change in Severity of Depression Using Hamilton Depression Rating Scale|"Evaluators administered the Hamilton Depression Rating Scale(Ham-D).~Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D).~Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D.~Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression."|Baseline, 12 weeks, 20 weeks|||units on a scale||Standard Deviation|Mean
164797|NCT00223496|Primary|Primary Measure:Reduction in Depression Symptoms|Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).|up to 12 weeks|||participants|||Number
164798|NCT00223236|Secondary|Rey Auditory Verbal Learning Test(RAVLT)|The RAVLT consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. The total score is the total number of words recalled through the five trials. Normative RAVLT T-scores was used. the higher T score, the better memory. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in RAVLT T scores between baseline and exit (exit - baseline).|Change in T scores between baseline and exit (exitT score - baseline T score).|number of participants are calculated based on those who completed baseline and at least one treatment visit.||T score||Standard Deviation|Mean
164799|NCT00223236|Secondary|Young Mania Rating Scale(YMRS).|The YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal and and 4 or 8 =most abnormal. The total possible score is 0 to 60, 0 being no symptom and 60 the worst symptom. The higher the score, the worse the mania symptoms are. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Baseline to exit (exit score - baseline score)|Numbers of participants are those who completed baseline assessment and at least one treatment visit.||units on a scale||Standard Deviation|Mean
164800|NCT00223236|Secondary|Inventory of Depressive Symptomatology Self Report (IDS-SR).|The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. The each item has a 4-likert scale, 0 to 3, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the tudy period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).|Change in scores between baseline and exit (exit - baseline).|Number of participants reported are those who completed baseline assessment and at least one treatment visit.||units on scale||Standard Deviation|Mean
164801|NCT00223236|Primary|Cocaine Use Determined by Urine Analysis|Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.|Biweekly (visit) urine drug screens|Number of participants are those who completed baseline assessment and at least one treatment visit followed by baseline.||percentage of participants no cocaine|||Number
164802|NCT00222729|Secondary|Overall Survival (OS)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg||months||90% Confidence Interval|Median
164803|NCT00222729|Secondary|Disease Control Rate (DCR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg||percentage||90% Confidence Interval|Median
164804|NCT00222729|Secondary|Objective Response Rate (ORR)||Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2||percentage||90% Confidence Interval|Median
164805|NCT00222729|Primary|Time-to-progression (TTP)|TTP was calculated from treatment initiation to disease progression or last follow-up.|Up to 36 months|Evaluable patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2||months||90% Confidence Interval|Median
164806|NCT00221299|Primary|Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.|In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.|BMD changes from year 1 to year 2|Per protocol||percent change||Standard Deviation|Mean
164807|NCT00221195|Primary|Reduction in the Number of Bleeds||6 months|||bleeds||Standard Deviation|Mean
164808|NCT00220961|Secondary|Change in Atherosclerosis|carotid intima thickness|Baseline versus 2.4 years|||percentage of intima||Standard Deviation|Mean
164832|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Baseline|||units on a scale||Standard Deviation|Mean
164809|NCT00220961|Secondary|Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)|Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.|Baseline versus 2.4 years|||matsuda index||Standard Deviation|Mean
164810|NCT00220961|Secondary|Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test|Insulin secretion|Baseline versus 2.4 years|||nmol||Standard Deviation|Mean
164811|NCT00220961|Secondary|Change From Baseline in Fasting Plasma Glucose of 2.4 Years|Fasting Plasma Glucose|Baseline versus 2.4 years|||mg/dl||Standard Deviation|Mean
164812|NCT00220961|Primary|Prevention of Type 2 Diabetes|Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization|2.4 years|||percentage of participants|||Number
164813|NCT00220805|Secondary|Mean Change From Baseline to Endpoint in Size of Lesion (Largest Dimension Relative to Disk Diameter) Assessed by Central Fluorescein Angiogram Reading Center||At end of treatment (12 weeks)|Intent to Treat||Disk Diameter||Standard Deviation|Mean
164814|NCT00220805|Secondary|Presence of Fibrosis and Location Assessed by Slit-lamp||Last measurement at or later than Week 8|Intent to Treat||participants|||Number
164815|NCT00220805|Secondary|Proportion of Subjects With an Increase ≥ 2 or More Points in Lens Opacity Classification System (LOCS III) for Nuclear Opalescence, Nuclear Color, Cortical Cataract or Posterior Subcapsular Cataract Categories|The LOCS III scale for cortical cataract and posterior subcapsular cataract opacity ranged from 1.0 to 5.0. The LOCS III scale for nuclear opalescence and for nuclear color was 1.0 to 6.0. For all scales, higher values indicate higher opacity, opalescence, or color.|Last measurement at or later than Week 8|Intent to Treat subjects with cataract||participants|||Number
164816|NCT00220805|Secondary|Mean Change in LogRAD Score From Baseline to Endpoint (RADNER Test)|The RADNER test gives not only information about the subject's reading performance, but also about the reading speed (life quality) and the faults while reading. The RADNER reading charts (1, 2, and 3) contain sentences in paragraphs having a range of print sizes starting with the largest print at the top.The subject was randomly assigned one of the RADNER charts, and the charts were different between consecutive visits. The reading distance was 25 cm. The subject's score was corrected for reading speed and errors. The range of possible logRAD scores was from 2.0 (could not read the first paragraph) to -0.2, with higher scores indicating lower reading acuity and lower scores indicating higher reading acuity.|Last measurement at or later than Week 8|Intent to Treat||LogRAD||Standard Deviation|Mean
164817|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.2 LogMAR||Last measurement at or later than Week 8|Intent to Treat||percentage of participants|||Number
164818|NCT00220805|Secondary|Proportion of Subjects Who Improve Visual Acuity From Baseline to Endpoint by ≥ 0.1 LogMAR||Last measurement at or later than Week 8|Intent to Treat||percentage of participants|||Number
164819|NCT00220805|Primary|Mean Change in Visual Acuity (Logarithm of the Minimum Angle of Resolution [LogMAR]) Score From Baseline for IGIV-C, 10% Compared to Placebo at Week 12 or at Last LogMAR Assessment (Conducted at or After Week 8 of the Treatment Period)|Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.|At Week 12 or, if the Week 12 assessment is not available, at the last LogMAR assessment conducted at or after Week 8 of the Treatment Period|The Intent-to-Treat (ITT) Population consisted of all randomized subjects who received any amount of study medication and had at least one evaluation of the primary efficacy variable (LogMAR score) at Week 8 or later and at Baseline.||LogMAR||Standard Deviation|Mean
164820|NCT00220779|Primary|Percentage of Relapse Free Subjects (no Relapse)|A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.|12 months|Intent-to-Treat (ITT) Population was all randomized subjects. This was the primary analysis population.||percentage of participants|||Number
164821|NCT00220779|Secondary|Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)||1 year||||||
164822|NCT00220740|Secondary|Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period||6 months|In the Randomized Withdrawal Period, 43 subjects were randomized to IGIV-C, but only 31 out of the 41 subjects were prior IGIV-C responders or rescue successes. Similarly, 31 subjects were randomized to Placebo, but only 26 out of the 31 subjects were prior IGIV-C responders or rescue successes.||weeks||Standard Deviation|Mean
164823|NCT00220740|Secondary|Mean Change in Grip Strength During the Efficacy Period||6 months|Intent-to-treat||kilopascal||Standard Deviation|Mean
164824|NCT00220740|Secondary|Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period|Mean changes in amplitude [mV] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)|6 months|Intent-to-treat||Millivolts||Standard Deviation|Mean
164825|NCT00220740|Primary|Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period|"The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period.~Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.~INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.~INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help"|6 months|The Intent-to-Treat Population was defined as all randomized subjects. This population was the primary efficacy population to be analyzed.||percentage of responders|||Number
164826|NCT00220727|Primary|Change From Baseline in Platelet Levels||24 hours Post infusion and Day 7|||Giga/L||Standard Deviation|Mean
164827|NCT00220727|Primary|Red Blood Cells|Red blood cells as a measure to assess hemolysis|24 hrs after treatment|||10^12 cells/L||Standard Deviation|Mean
164828|NCT00220727|Primary|Hematocrit|Hematocrit as a measure to assess hemolysis|24 hrs after treatment|||percentage of blood||Standard Deviation|Mean
164833|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Baseline|||units on a scale||Standard Deviation|Mean
164834|NCT00220701|Secondary|Beck Depression Inventory (BDI)|21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.|Baseline|||units on a scale||Standard Deviation|Mean
164835|NCT00220701|Secondary|Clinical Global Impressions - Severity (CGI-S)|Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)|Week 12|||units on a scale||Standard Deviation|Mean
164836|NCT00220701|Primary|Hamilton-Depression Rating Scale (HDRS-24 Items)|Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)|Week 12|||units on a scale||Standard Deviation|Mean
164837|NCT00220636|Secondary|Change in Beck Depression Inventory (BDI) Score|"21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.~Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment."|baseline and 12 weeks|Number of participants for whom data was available after starting aripiprazole augmentation||points on BDI scale||Standard Deviation|Mean
164838|NCT00220636|Secondary|Change in Global Assessment of Functioning Scale (GAFS)|Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.|baseline and 12 weeks|All subjects (14/15) for whom data was available after starting aripiprazole augmentation||points on GAFS scale||Standard Deviation|Mean
164839|NCT00220636|Secondary|Clinical Global Impressions Improvement Scale (CGI)|clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)|12 weeks|all subjects for whom data was available after beginning aripiprazole augmentation (14 of 15 subjects)||units on CGI scale||Standard Deviation|Mean
164840|NCT00220636|Primary|Hamilton Depression Rating Scale (HDRS)|"Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression responded after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12."|12 weeks|Adults with treatment resistant depression, all subjects with data after baseline (14 of 15 subjects).||participants|||Number
164841|NCT00219557|Secondary|Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study|QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms.|Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.||units on a scale||Standard Deviation|Mean
164842|NCT00219557|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).|Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.||units on a scale||Standard Deviation|Mean
164843|NCT00219557|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.|Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Percent chance of survival||95% Confidence Interval|Number
164844|NCT00219557|Secondary|Progression-free Survival (PFS)|"Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Days||95% Confidence Interval|Number
164939|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164845|NCT00219557|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks|Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
164846|NCT00219557|Secondary|Percentage of Participants With Overall Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.|Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks|Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Percentage of Participants||95% Confidence Interval|Number
164847|NCT00219557|Secondary|Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks||||||
164848|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Gemcitabine|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||hr||Standard Deviation|Mean
164849|NCT00219557|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng*hr/mL||Standard Deviation|Mean
164850|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) of Gemcitabine||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
164851|NCT00219557|Secondary|Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.||hr||Standard Deviation|Mean
164852|NCT00219557|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)|Tmax was based on the actual time points when the samples were collected.|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.||hr||Full Range|Median
164853|NCT00219557|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)|AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).|0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Pase 1 Cycle 1|Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.||ng*hr/mL||Standard Deviation|Mean
164854|NCT00219557|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)||0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1|Phase 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
164855|NCT00219557|Secondary|Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 Baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
164856|NCT00219557|Secondary|Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)|Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.|Phase 1 baseline up to Week 4|Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.||participants|||Number
164857|NCT00219557|Primary|Overall Survival (OS)|Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant|Phase 2 intent to treat (ITT) population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.||Days||95% Confidence Interval|Median
164858|NCT00219544|Secondary|Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components|two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)|Week 9|||score on scale||Standard Error|Least Squares Mean
164859|NCT00219544|Secondary|Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.|Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.|Week 9|FAS population||score on scale||Standard Error|Least Squares Mean
164860|NCT00219544|Secondary|Patient Global Impression of Change (PGIC) Categories by Number of Subjects|"Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject’s overall status on a 7-point scale. Scores range from~1 (very much improved) to 7 (very much worse)."|Week 9|FAS Population||participants|||Number
164861|NCT00219544|Secondary|Change in Pain Treatment Satisfaction Scale (PTSS)|"Mean Change: score from observation minus score from randomization: PTSS “Impact” module of 8-items & “Satisfaction” module of 6-items; item scores 1-5.~Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100~=best possible response: Score =[(5 – mean non-missing items)*100]/4."|Week 9|||score on scale||Standard Error|Least Squares Mean
164862|NCT00219544|Secondary|Change in Hospital Anxiety and Depression Scale Responses|Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.|Week 9|FAS population||score on scale||Standard Error|Least Squares Mean
164863|NCT00219544|Secondary|Intensity of Neuropathic Pain –Visual Analog Scale (NeP – VAS)|Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain –Visual Analog Scale (NeP – VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 4, Week 9|||scores on a scale||Standard Error|Least Squares Mean
164864|NCT00219544|Secondary|Change in Sleep Interference Scores During Double Blind Treatment Phase|"Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep."|9 weeks|Full Analysis Set (FAS)||score on scale||Standard Error|Least Squares Mean
164865|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase|Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|Week 9|||score on scale||Standard Deviation|Mean
164866|NCT00219544|Secondary|Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase|Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|0 and 4 weeks|Last observation carried forward (LOCF) approach for patients who do not complete the study will be adopted. This is defined as the mean of the last 7 diary scores while on Double-Blind study drug, up to and including the day after the last day on drug (excluding the taper phase).||score on scale||Standard Deviation|Mean
164867|NCT00219544|Secondary|Mean Sleep Interference Score|Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means “pain does not interfere with sleep” and 10 means “pain completely interferes with sleep.”|Week 9|FAS population.||score on scale||Standard Error|Least Squares Mean
164868|NCT00219544|Secondary|Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)|Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .|Week 9|||participants|||Number
164869|NCT00219544|Secondary|Categorized Daily Pain Score|Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)|Week 9|Number of subjects analyzed for each pain category.||days||Standard Deviation|Mean
164870|NCT00219544|Secondary|Mean Pain Score for Non-responders at End of Single-blind Treatment Phase|Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 (“no pain”) to 10 (“worst possible pain”). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.||score on scale||Standard Deviation|Mean
164871|NCT00219544|Secondary|Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.|Daily Pain Rating Score:11-point numerical scale 0 (“no pain”) to 10 (“worst possible pain”). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.|Week 4|number of subjects that can be analyzed for Change from Baseline at End of Single Blind.||score on scale||Standard Deviation|Mean
164872|NCT00219544|Secondary|Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment|Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|Week 4 (end of single-blind treatment phase)|256 subjects entered the single-blind treatment phase, one subject did not have enough DPRS assessments for calculation.||participants|||Number
164873|NCT00219544|Secondary|Change in Pain Scores During Double Blind Treatment Phase|Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|9 weeks|Full Analysis Set (FAS)||score on scale||Standard Error|Least Squares Mean
164874|NCT00219544|Secondary|Weekly Mean Pain Scores During the Double Blind Treatment Phase|Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|Week 4 - 9|FAS population.||score on scale||Standard Deviation|Mean
164875|NCT00219544|Secondary|Weekly Mean Pain Scores During the Single-blind Treatment Phase|Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|0 and 4 weeks|Full Analysis Set (FAS)||score on scale||Standard Deviation|Mean
164876|NCT00219544|Primary|Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase|Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (“no pain”) to 10 (“worst possible pain”).|9 weeks|Full Analysis Set (FAS) = Intent-to-Treat (ITT) population, defined as all subjects who are randomized into the Double-Blind treatment phase, who receive at least one dose of Double-Blind study medication and complete at least one postrandomization efficacy assessment.||score on scale||Standard Error|Least Squares Mean
164877|NCT00219349|Secondary|Beck Depression Inventory-II||week 14 to week 26||||||
164878|NCT00219349|Secondary|Hamilton Rating Scale for Depression||week 14 to week 26||||||
164879|NCT00219349|Primary|Change in Hamilton Anxiety Scale Score||week 14 to week 26||||||
164880|NCT00219349|Primary|State-Trait Anxiety Inventory||week 14 to week 26||||||
164881|NCT00219349|Primary|Penn State Worry Questionnaire||week 14 to week 26||||||
164882|NCT00219349|Primary|GAD Severity Scale||week 14 to week 26||||||
164883|NCT00219349|Primary|Clinical Global Impressions-Severity Index||week 14 to week 26||||||
164884|NCT00219349|Primary|Clinical Global Impressions-Improvement Index||week 26||||||
164885|NCT00219349|Primary|Change in Hamilton Anxiety Rating Scale Score|The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.|week 14 to week 26|see above: Patients who completed the CBT phase and started escitalopram treatment||units on a scale||Standard Deviation|Mean
164886|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to End of Treatment|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQ-39 scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164887|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to End of Treatment|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment PDQUALIF scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164888|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to end of treatment (Week 16 in the Immediate Switch group, Week 20 in the Delayed Switch group)|ITT population - For each patient, the last post-baseline measurement during the treatment phase was used as the end-of-treatment measurement. Only patients with baseline and end-of-treatment UPDRS part III scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164898|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Stroke Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mL||Standard Deviation|Mean
164889|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 8|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQ-39 scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164890|NCT00219284|Secondary|Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Week 4|The PDQ-39 is another instrument used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 156. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQ-39 scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164891|NCT00219284|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 8|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5-point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 UPDRS part III scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164892|NCT00219284|Secondary|Change in Parkinson's Disease Quality of Life Score From Baseline to Week 8|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 8 PDQUALIF scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164893|NCT00219284|Secondary|Change in Parkinson’s Disease Quality of Life Score From Baseline to Week 4|Quality of life was assessed with the Parkinson’s Disease Quality of Life Instrument (PDQUALIF), a 33-item self-reported questionnaire which includes seven domains: Social/role function, self-imaging/sexuality, sleep, outlook, physical function, independence, and urinary function. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The 1 to 5 range was recoded to 0 to 4 for the analysis. The total score can range from 0 to 132. A lower score indicates better quality of life. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 PDQUALIF scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164894|NCT00219284|Primary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score From Baseline to Week 4|Motor function was assessed with the UPDRS part III. There are 14 items in the instrument, each measured on a 5 point scale (0-4): Speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. The sum of scores can range from 0 to 56; a higher score indicates greater disability. A negative change score indicates improvement.|Baseline to Week 4|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable. Only patients with baseline and Week 4 UPDRS part III scores were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
164895|NCT00219141|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic and Systolic Blood Pressure From Baseline to the End of the Study (Week 36)|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, blood pressure was measured at study specified intervals.|Baseline the end of study (Week 36)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.||mm Hg||Standard Error|Least Squares Mean
164896|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Cornell Voltage Duration Product as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.||mm * ms||Standard Deviation|Mean
164897|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Sokolow-Lyon Voltage as Measured by Electrocardiogram From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Intent-to-treat population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement.||mm||Standard Deviation|Mean
164899|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Ejection Fraction as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||percent||Standard Deviation|Mean
164900|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Mass as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||g||Standard Deviation|Mean
164901|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Diameter of Ascending Aorta as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mm||Standard Deviation|Mean
164902|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Inferolateral Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mm||Standard Deviation|Mean
164903|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Anteroseptal Wall Thickness as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mm||Standard Deviation|Mean
164904|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Systolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mL||Standard Deviation|Mean
164905|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular End Diastolic Volume as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||mL||Standard Deviation|Mean
164906|NCT00219141|Secondary|Change in the Left Ventricular Hypertrophy (LVH) Parameter Left Ventricular Mass Index as Measured by MRI From Baseline to End of Study (Week 36)||Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||g/m^2||Standard Deviation|Mean
164907|NCT00219141|Primary|Change in Left Ventricular Mass Index (LVMI) From Baseline to End of Study (Week 36)|Left ventricular mass index (LVMI) was measured by magnetic resonance imaging (MRI). An increase in LVMI indicates hypertrophy of the left ventricle. This could be a normal reversible response to cardiovascular conditioning (athletic heart) or an abnormal irreversible response to chronically increased volume load (preload) or increased pressure load (afterload). Thickening of the ventricular muscle results in increased left ventricular pressure, increased end-systolic volume, and decreased end-diastolic volume, causing an overall reduction in cardiac output.|Baseline to end of study (Week 36)|Efficacy population: All patients who had a baseline measurement and at least one post-baseline efficacy variable measurement patients and who had been treated for at least 28 weeks and had evaluable MRI assessments both at baseline and at the end of the study.||g/m^2||Standard Error|Least Squares Mean
164908|NCT00218634|Secondary|CD4+ Lymphocyte Count at 3-month Follow-up Assessment.|CD4+ lymphocyte cell count at 3-month follow-up assessment.|3-month assessment|We used intent to treat for all analysis.||cells/mm3||Standard Deviation|Mean
164909|NCT00218634|Secondary|HIV Viral Load at 3-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.|3-month assessment|We used intent to treat for all data analysis.||"log10 copies/mL"||Standard Deviation|Mean
164910|NCT00218634|Secondary|Clinician-assessed Depression at 12-month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|12-month follow-up assessment|We used intent to treat for all data analysis.||Units on scale||Standard Deviation|Mean
164911|NCT00218634|Primary|Percent Medication Adherence at 12-month Follow-up Assessment|Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|12-month follow-up assessment|We used intent to treat for all data analysis.||percent (doses taken/doses prescribed)||Standard Deviation|Mean
164912|NCT00218634|Secondary|CD4+ Lymphocyte Count at 12-month Follow-up Assessment.|CD4+ lymphocyte cell count at 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.||cells/mm3||Standard Deviation|Mean
164913|NCT00218634|Secondary|HIV Viral Load at 12-month Follow-up Assessment|HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.|12-month follow-up assessment|We used intent to treat for all data analysis.||"log10 copies/mL"||Standard Deviation|Log Mean
164914|NCT00218634|Secondary|Clinician-assessed Depression Rating at 3 Month Follow-up Assessment|Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.|3 month follow-up|We used intent to treat for all data analysis.||Units on scale||Standard Deviation|Mean
164915|NCT00218634|Primary|Percent Medication Adherence at 3-month Follow-up Assessment|Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.|3-month assessment|We used hierarchical linear modeling (HLM) methods and intent to treat for all randomized participants.||percent (doses taken/doses prescribed)||Standard Deviation|Mean
164916|NCT00218543|Primary|ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)|Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.|measured during 12 weeks or length of study participation|Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed||scores on a scale||Standard Deviation|Mean
164917|NCT00218543|Primary|the Adult ADHD Rating Scale (AARS) (30% Reduction)|AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.|baseline compared to rating at week 12 or last rating during study participation|All participants||percent of participants|||Number
164918|NCT00218465|Primary|Days to Relapse Within the 60 Days Following Randomization||60 days|||days||Standard Deviation|Mean
164919|NCT00218465|Primary|Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial||5 weeks|||participants|||Number
164920|NCT00218465|Primary|Time to Relapse to Smoking in the 5-week Relapse Prevention Phase.||5 weeks|||days||Standard Deviation|Mean
164921|NCT00218439|Other Pre-specified|Plasma Norepinephrine Concentration Response to Stress|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||pg / ml||Standard Error|Mean
164922|NCT00218439|Other Pre-specified|Plasma Epinephrine Concentration Response to Stress|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||pg / ml||Standard Error|Mean
164923|NCT00218439|Other Pre-specified|Heart Rate Response to Stress|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||beats/minute||Standard Error|Mean
164924|NCT00218439|Other Pre-specified|Diastolic Blood Pressure Response to Stress|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||mm Hg||Standard Error|Mean
164925|NCT00218439|Primary|Systolic Blood Pressure Response to Stress|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette|After 4 weeks of paroxetine / placebo|||mmHg||Standard Error|Mean
164926|NCT00218335|Primary|Talked About Hepatitis to Drug Buddies||18 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164927|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164928|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in Past Month)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164929|NCT00218335|Primary|Injecting Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164930|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164931|NCT00218335|Primary|Shared Cooker When Preparing Drugs||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164932|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||18 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164933|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164934|NCT00218335|Primary|Talked About HIV-related Topics With Drug Buddies (in the Past Month)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164935|NCT00218335|Primary|Number of Needle or Cooker Sharers (2 or More Versus None)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164936|NCT00218335|Primary|Any Injection Risk (Monthly Versus Never)||12 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164937|NCT00218335|Primary|Talked About Responding to Overdose to Drug Buddies||6 months|Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164938|NCT00218335|Primary|Showed a Needleless Syringe to Drug Buddies||6 months|The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.||participants|||Number
164941|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 32|Continuous Abstinence from quit date through Week 32 (Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks|||percentage of randomized|||Number
164942|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).|32 Weeks|||percentage of randomized|||Number
164943|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 26|Continuous Abstinence from quit date through Week 26 (Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).|26 weeks|Intent to treat||percentage of randomized|||Number
164944|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)|Abstinence from tobacco 7 days prior to Week 26 (Assessed 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)|26 week|||percentage of randomized|||Number
164945|NCT00218296|Primary|Percent Prolonged Abstinence From Tobacco at Week 12|Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks|||percentage of randomized|||Number
164946|NCT00218296|Primary|Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)|No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)|12 weeks|Intent to treat||percentage of randomized|||Number
164947|NCT00217971|Primary|Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial|Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.|weeks 7 and 8|||participants|||Number
164948|NCT00217724|Secondary|Number of Participants With Attenuation of Myalgias or Arthralgias Not Receiving Glutamine as Measured by Pain Scale Diaries on Days 1 and 3 of Courses 1 and 2||Duration of participation on study (up to one year)||||||
164949|NCT00217724|Primary|Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy|Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by > 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by >25% from baseline scores|2 courses of chemotherapy (6 weeks)|Fourteen of the 18 patients enrolled received both cycles of therapy and were thus evaluable for the primary endpoint||participants|||Number
164950|NCT00217672|Secondary|Comparison of Safety and Toxicity|Evaluated using adverse event (AE) information. Detailed AE information is provided in the AE section.|When adverse events occur, up to 30 days after last dose for each subject, up to 3 years from start of study|||subjects|||Number
164951|NCT00217672|Secondary|Comparison of Response Rates, Duration of Response, and Overall Survival||Time of death, up to 3 years|Response rate – the percentage of patients assigned to a treatment arm who experience a CR or PR. Duration of response – the interval from date of initial documented response (CR or PR) to the first documented date of disease progression. Overall survival – the interval from the date of registration and the date of death.||months||95% Confidence Interval|Median
164952|NCT00217672|Primary|Antitumor Activity Based on Time to Tumor Progression (TTP).||From randomization until tumor progression|76 participants were registered to the Treatment, 7 to arm A and 69 to arm B. 6 participants randomized to arm A elected to cross over to arm B once Avastin became available. 2 out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. Thus, the efficacy analysis performed on 67 patients.||months||95% Confidence Interval|Median
164953|NCT00217620|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 – Severe, Grade 4 – Life-threatening, Grade 5 – Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
164954|NCT00217620|Primary|Objective Response (Confirmed, Complete and Partial)|Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.|Assessment performed every eight weeks until progression.|Eligible patients who had received any treatment were included in this analysis.||participants|||Number
164955|NCT00217620|Secondary|Four-month Progression-free Survival Rate||0 - 4 months|Eligible patients who had received any treatment were included in this analysis.||percentage of participants||95% Confidence Interval|Number
164956|NCT00217581|Secondary|Quality of Life by EORTC Quality of Life Questionnaire (QLQ) and QLQ-STO22 for Gastric Cancer||at baseline and every 14-17 days after day 1 cycle 1 until the completion of the study or until week 26||||||
164957|NCT00217581|Secondary|Overall Survival||Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years||||||
164958|NCT00217581|Secondary|Time to Treatment Failure||Every 21 days||||||
164959|NCT00217581|Secondary|Toxicity Profile||At 21 days following completion of study treatment||||||
164960|NCT00217581|Secondary|Response Rate by RECIST Criteria Until Progression||After every 2 cycles (1 cycle =21 days)||||||
164961|NCT00217581|Primary|Time to Progression||After every 2 cycles (1 cycle =21 days)|||months||95% Confidence Interval|Median
164962|NCT00217464|Secondary|Number of Participants With Progressive Disease at Day +90|Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients||participants|||Number
164963|NCT00217464|Primary|Proportion of Patients Who Respond to Treatment.|Response is defined to be the clear slowing of the rate of increase of PSA levels with time|90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
164964|NCT00217438|Secondary|Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2|Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.|Up to day 56 after transplant|Patients who were treated per protocol.||Grade 3-4 adverse events|||Number
164965|NCT00217438|Primary|CR and Near CR Rates|"Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. Near Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey."|Up to 120 days after transplant|Per protocol, patients who completed the day 80-120 evaluation assessments.||percentage of participants|||Number
164966|NCT00217425|Secondary|3-Year Overall Survival|3-year overall survival is defined as the probability of patients surviving at 3 years from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
164967|NCT00217425|Secondary|Overall Response Rate|Overall response rate is defined as proportion of patients who achieve complete remission [CR, unconfirmed CR (CRu) or Functional CR] or partial remission. Response is assessed using the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Chesen, 1999).|Assessed after cycle 3, cycle 6, and cycle 8 (if given).|Eligible and treated||proportion||95% Confidence Interval|Number
164968|NCT00217425|Primary|12-Month Progression-Free Survival (PFS)|12-month progression-free survival is defined as the probability of patients remaining alive and progression-free at 12 months from study entry.|Assessed every 3 months the first 2 years from study entry and every 6 months 3-5 years from study entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
164969|NCT00217399|Secondary|Tumor Marker Analysis|Number of participants with significant change in the following circulating tumor biomarkers, measured by flow cytometry: cluster designation (CD)146, CD133. Values were normalized by CD45 values(ie CD146+/CD45- and CD133+/CD45-).|1 year|14 subjects had blood specimens available for analysis||participants|||Number
164970|NCT00217399|Secondary|Number of Participants With Adverse Events|Number of patients treated with the sorafenib / anastrozole combination who experienced Grade 1-4 adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0|1 year|All 35 patients enrolled in the study were assessed for adverse events according to NCI common terminology criteria for adverse events (CTCAE) version 3.0.||participants|||Number
164971|NCT00217399|Primary|Complete Response + Partial Response + Stable Disease > 24 Weeks|"Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking.~A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks."|24 weeks|Female patients with advanced or metastatic breast cancer. The protocol was initiated with intention to treat every patient enrolled with a sorafenib and anastrozole combination.||participants|||Number
164972|NCT00217087|Primary|Change in Quality of Life|Quality of life in both groups (EMR and EMR with photodynamic therapy) SF36|end of study|25 patients did not return completed SF36 at 12 month of follow up their results were not used in final analysis.||participants|||Number
164973|NCT00217087|Primary|Fluorescence In Situ Hybridization (FISH) Markers at 12 Months.|"Whether or not positive fish markers measured by polysomy were associated with outcomes.~Markers in this study include: 9q21 /017q (her2) / 8q24/ 20q / CEP17 / 17p. Polysomy and Trisomy were documented."|12 months post therapy|4 participants in the PDT group completed at least 3 months of follow up but not 12 months||participants|||Number
164974|NCT00217087|Primary|Level of Dysplasia on Histology at 12 Months|All specimens were reviewed by two expert GI pathologists for presence of and/or level of dysplasia in Barrett's Esophagus|12 months post therapy|4 participants in the photodynamic therapy group completed at least 3 but less than 12 months follow up post therapy, so they were not included in this analysis.||paricipants|||Number
164975|NCT00217022|Secondary|Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies|The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale (“normal” (0), “mildly increased” (1), “moderately increased” (2), “severely increased” (3)).|Baseline (day 1 of study) and at eight weeks (approximately)|Only 8 of the subjects on the budesonide arm returned for the biopsy, so only those subjects on that arm were analyzed for this outcome measure.||participants|||Number
164976|NCT00217022|Primary|Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks|"Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of satisfactory control of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks."|Three out of last four weeks that the subject was on the study|||participants|||Number
165205|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 6 Months|||percentage of participants|||Number
164977|NCT00216736|Post-Hoc|Proportion of Patients With Recurrent Headache Within 48 Hours for Patient Subgroup With Duration of Migraine Less Than 24 Hours|Proportion of patients who report recurrent headache within 48 hours for the patient subgroup with duration of migraine less than 24 hours|48 hours|||Participants|||Number
164978|NCT00216736|Secondary|Proportion of Patients Requiring Additional Analgesia Within 48 Hours for Headache.|Proportion of patients reporting a requirement for additional analgesia within 48 hours of treatment for headache, by telephone followup.|48 hours|||Participants|||Number
164979|NCT00216736|Primary|Proportion of Patients With Recurrent Headache Within 48 Hours.|Proportion of patients who report recurrent headache within 48 hours, on telephone followup.|48 hours|||Partcipants|||Number
164980|NCT00216736|Primary|Proportion of Patients Who Were Discharged Pain Free That Have a Recurrence of Headache Within 48 Hours.|Proportion of patients who were discharged pain free who report recurrence of headache within 48 hours, on telephone followup.|48 hours|||Participants|||Number
164981|NCT00216671|Secondary|Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12|Short Form Health Survey: A generic dual–ie, mental and physical health–scale measure of quality of life. This is a 12-item subset of the SF-36 survey that measures the same 8 domains of health. As a brief, reliable measure of overall health status, the SF-12 is the instrument of choice in large population health surveys and has been used extensively as a screening tool. SF-12 will be filled in by the patient. The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.An additional 9 and 11 patients in the respective groups had missing SF-12 data.||scores on a scale||Standard Deviation|Mean
164982|NCT00216671|Secondary|Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)|Overall psychological, social, and occupational functioning is rated on a scale of mental health-illness from 1 being the worst functioning to 100 being the best. Impairment in functioning due to physical (or environmental) limitations must not be included in the rating.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initation group has missing GAF data.||scores on a scale||Standard Deviation|Mean
164983|NCT00216671|Secondary|Change From Baseline to Endpoint in Clinical Global Impression – Severity (CGI-S)|The CGI-S rating scale is used to rate the severity of a subject’s psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the subject’s condition at a given time.|at baseline and endpoint (week 26 or at premature discontinuation).|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initiation group has missing CGI-S data.||scores on a scale||Standard Deviation|Mean
164984|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 12|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 12.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 9 and 23 patients in the respective groups had missing PANSS data.||scores on a scale||Standard Deviation|Mean
164985|NCT00216671|Secondary|Change From Baseline in PANSS Total Score at Week 6|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210.|at baseline and Week 6.|Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 3 and 5 patients in the respective groups had missing PANSS data at week 6.||scores on a scale||Standard Deviation|Mean
164986|NCT00216671|Primary|Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint|The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210.|at baseline and Week 26 or at premature discontinuation|Per Protocol analysis: all randomized patients who had no violation on eligibility criteria or no major protocol violation. This excluded 42 patients in the early and 34 in the late initiation group. 1 patient in the early initiation group had no PANSS at endpoint. The endpoint is the last post-baseline value of the patient.||scores on a scale||Standard Deviation|Mean
164987|NCT00216476|Secondary|Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores|Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL.|Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. An additional 32, 32, and 2 subjects in the respective arms did not have SF-12 data.||units on a scale||Standard Deviation|Mean
164988|NCT00216476|Secondary|Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score|The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject’s psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects).|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm, 11 of the quetipaine arm, and 1 of the aripiprazole arm. One additional subject in the risperidone LAI arm did not have CGI data.||units on a scale||Standard Deviation|Mean
165127|NCT00211692|Secondary|Participants Achieving SVR Categorized by Time of Response|rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks|24 weeks after end of treatment|participants with analyzable data for this outcome||participants|||Number
164989|NCT00216476|Secondary|Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score|"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).~Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme)."|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. One additional subject in each the risperidone LAI and quetiapine arm did not have PANSS data.||units on a scale||Standard Deviation|Mean
164990|NCT00216476|Secondary|Mean Relapse Free Period (Exploratory/Aripiprazole)|As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 1 subject of the aripiprazole arm.||days||Standard Error|Mean
164991|NCT00216476|Primary|Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)|Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.|Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)|Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm and 11 of the quetiapine arm.||days||Standard Deviation|Mean
164992|NCT00216320|Primary|10 Meter Walking Speed Before and After Intervention.|Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks|||meters/second||Standard Deviation|Mean
164993|NCT00216320|Primary|Physiological Cost Index Before and After Intervention.|PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks|||beats/minute||Standard Deviation|Mean
164994|NCT00216320|Primary|Figure 8 Walking Speed Before and After Intervention.|Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks|baseline, 6, 6.2 and 12 weeks|||meters/second||Standard Deviation|Mean
164995|NCT00216320|Secondary|Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO|Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference|12 weeks|per protocol (completers) analysis||participants|||Number
164996|NCT00216203|Secondary|Clinical Benefit Rate|Clinical Benefit Rate (CR + PR + SD lasting more than 90 days)|12 months|Data was not collected or analyzed for this secondary objective.|||||
164997|NCT00216203|Secondary|Toxicity and Safety Profile||12 months|||percentage of particpants|||Number
164998|NCT00216203|Secondary|Median Survival Time||24 Months|27 participants had data sufficient to complete Median Survival Time analysis||weeks||95% Confidence Interval|Median
164999|NCT00216203|Primary|Time To Progression (TTP)|The primary objective of the phase II portion is to estimate the time to progression of this combination, evaluated per RECIST criteria where PD= at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 Months|27 participants had enough data to complete TTP analysis||Weeks||95% Confidence Interval|Median
165000|NCT00216203|Primary|Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cetuximab|The primary objective of the phase I portion of this study is to define the maximum tolerated dose (MTD) of the combination of pemetrexed and cetuximab|12 months|12 participants participated in the phase I portion of the trial.||mg/m^2 every 21 days|||Number
165001|NCT00216125|Secondary|Progression Free Survival|"A comparison of progression free survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median PFS time and a log rank test were used to analyze the hypothesized improvement in progression free survival.~Progression is defined by RECIST as a 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion."|Participants were monitored from treatment initiation until disease progression per RECIST or death|||months||95% Confidence Interval|Median
165002|NCT00216125|Primary|Overall Survival|A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.|Participants were measured from treatment initiation to death|The analysis cohort for the results reported below are based on a planned interim DSMB evaluation conducted in 2006. This evaluation concluded that further accrual was futile and the study should be terminated. The 203 subjects included in this analysis had data sufficiently mature at the time of the DSMB analysis.||Months||95% Confidence Interval|Median
165003|NCT00216099|Secondary|Time to Prostate-Specific Antigen (PSA)/Serological Progression|Serological Progression (sPD) – increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline|From study enrollment to progression per PSA criteria (for life)|||months||95% Confidence Interval|Median
165004|NCT00216099|Secondary|Time to Progression|Progression per Response Evaluation Criteria in Solid Tumors (RECIST) or Prostate-Specific Antigen (PSA) Progression RECIST PD=at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions PSA progression=increase in PSA to >50% above lowest level recorded on study. Two consecutive increases required at least 4 weeks apart, but time to progression will be determined at time of first PSA showing increase > 50% above baseline *Note, upper confidence interval was not reached*|Study enrollment until progression per RECIST or PSA (for life)|||months||95% Confidence Interval|Median
165005|NCT00216099|Secondary|RFC1 G80A Genotype|Samples for RFC1 G80A pharmacogenetic analysis were collected at screening|Screening|Samples were available from 46 patients||participants|||Number
165006|NCT00216099|Secondary|Safety and Tolerability|Safety and Tolerability was evaluated by reporting the percentage of patient who experienced grade 3 or 4 toxicities using Common Terminology Criteria for Adverse Events CTCAE v3.0 criteria. CTCAE grades the severity of an adverse event from 1-5 where 1=least severe and 5=death.|18 months|||percentage of participants||95% Confidence Interval|Number
165007|NCT00216099|Secondary|Rate of Clinical Benefit|"A clinical benefit is defined as an improvement for at least 3 consecutive weeks in at least one of the following parameters without any sustained worsening in any other:~> 50% reduction in analgesic consumption or > 50% reduction in pain intensity or > 20 point gain in performance status."|Any time among evaluable subjects (for life)|||percentage of participants||95% Confidence Interval|Number
165008|NCT00216099|Secondary|OBJECTIVE Overall Response Rate|"Response Evaluation Criteria in Solid Tumors (RECIST). Objective overall response rate is defined as Complete Response (CR) + Partial Response (PR)~Per RECIST:~CR= Disappearance of all target and non-target lesions and normalization of tumor marker level PR= Disappearance of all target lesions and persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits OR at least a 30% decrease in the sum of the longest diameter, taking as reference the baseline sum longest diameter and disappearance of all non-target lesions or persistence of non-target lesion(s) or maintenance of tumor marker level above normal limits"|Start of treatment until disease progression/recurrence (for life)|Patients who had measurable disease per RECIST 1.1 at baseline. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >20 mm using conventional techniques or >10 mm with spiral CT scan.||percentage of participants||95% Confidence Interval|Number
165009|NCT00216099|Secondary|Overall Survival||From study enrollment until death (for life)|||months||95% Confidence Interval|Median
165010|NCT00216099|Primary|Best Overall PSA Response|"Best overall Prostate-Specific Antigen (PSA) response~PSA response is defined by a greater than or equal to 50% decline in PSA confirmed by a second PSA value at least 4 weeks after the first PSA response timepoint PSA Stable Disease is defined as less than a 50% decline in PSA and less than a 50% increase in PSA from baseline PSA progression is defined as greater than or equal to a 50% increase in PSA compared to baseline"|Start of treatment until disease progression/recurrence (for life)|||percentage of participatns||95% Confidence Interval|Number
165011|NCT00216086|Secondary|Disease-Free Survival|The three year rate of Disease-Free Survival|36 months|||percentage||95% Confidence Interval|Number
165012|NCT00216086|Secondary|Rate of Clinical Response|To determine the rate of clinical response following induction chemotherapy with capecitabine and irinotecan, and also the overall clinical response after the completion of chemoradiation with capecitabine.|36 months|Data for this secondary objective was not captured or analyzed due to the withdrawal of funding and subsequent termination of the study.|||||
165013|NCT00216086|Secondary|Local and Distant Disease Recurrence Rates|To determine the rates of local and distant disease recurrence after treatment.|36 months|||percentage of particpants|||Number
165014|NCT00216086|Primary|Pathological Complete Response (pCR) Rate|"· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer.~Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients."|36 months|||percentage of patients||95% Confidence Interval|Number
165015|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum Osteocalcin (OC)|Serum Osteocalcin (OC) medians between baseline and 24 weeks areperformed with the Elecsys 2010 automated analyzer, which uses an electrochemiluminescence immunoassay technique for the in vitro quantitative determination of serum total osteocalcin in humanserum. The assay uses a sandwich test principle in which afirst biotinylated monoclonal antibody recognizing N-MID osteocalcin and a second monoclonal antibody against N-MID osteocalcin labeled with ruthenium are incubated with 20mL of serum. After a first incubation, streptavidin-coated microparticles are added for a second incubation, and the complex becomes bound to the solid phase by interaction of biotin and streptavidin.These microparticles are then magnetically captured onto the surface of an electrode. Application of a voltage on this electrode induces chemiluminescent emission, which is measured by a photomultiplierand compared with a calibration curve that is generated in aninstrument-specific manner by 2-point calibration.|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.||ug/L||Standard Deviation|Median
165016|NCT00216060|Secondary|Bone Turnover Marker Changes-- Serum BAP|Serum BAP median changes between baseline and week 24. The Ostase assays are performed with an access immunoassay system, which is an assay of serum samples that provides a quantitative measurement of bone alkaline phosphatase (BAP). A mouse monoclonal antibody specific to BAP is added to a re-action vessel with paramagnetic particles coated with goat antimouse polyclonalantibody.Calibrators,controls,andsamplescontainingBAP are added to the coated particles and bind to the anti-BAP monoclonal antibody. After the formation of a solid phase/capture antibody/BAP complex, separation in a magnetic field and washing remove materials not bound to the solid phase. A chemiluminescent substrate, LumiPhos 530, is added to the reaction vessel, and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BAP in the sample. The amount of analyte in thesample is determined from a stored multipoint calibration curve|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.||ng/mL||Standard Deviation|Median
165128|NCT00211692|Secondary|Number of Participants Discontinuing Early From Study Treatment||through end of study up to 72 weeks|||participants|||Number
165017|NCT00216060|Secondary|Bone Turnover Marker Changes-- Urine N-telopeptide (NTX) Median|"Urine N-telopeptide (NTX) median changes between baseline and week 24. The assays are performed with the NTx Reagent Pack kit from Ortho-Clinical Diagnostics (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK), which is a kit designed for the quantitative determination of N-terminal telopeptide (NTx) in human urine on the automated Vitros Immunodiagnostic System ECi (Ortho-Clinical Diagnostics/Johnson & Johnson, Amersham, UK). A competitive immunoassay technique is used. This depends on competition between NTx present in the sample and a synthetic NTx peptide coated on the wells for binding by a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-NTx). The conjugate is captured by the peptide coated on the wells; unbound materials are removed by washing.~The bound HRP conjugate is measured by a luminescent reaction."|24 week|Number of Participants Analyzed reflects participants who had data available prior to study termination.||nmol BCE/mmol creatinine||Standard Deviation|Median
165018|NCT00216060|Secondary|Three- Year Survival Rate||36 months|||percentage of participants||95% Confidence Interval|Number
165019|NCT00216060|Secondary|Bone Turnover Marker Changes -- Urine Total Deoxypyridinoline (DPD)|"Urine total DPD median in response to treatment on both study arms at week 24. compare median from baseline and week 24.~Deoxypyridinoline (DPD) is measured in hydrolyzed urine samples using high-performance liquid chromatography technique. After extraction of the cross-links and elimination of the urine impurities by a Bio-Rad SPE cartridge (Bio-Rad Laboratories, Hercules, CA), total DPD is eluted from reverse-phase high-performance liquid chromatography by ion pair chromatography with isocratic elution.~The compounds are detected as a result of their natural fluorescence with a fluorescence detector"|24 weeks|Number of Participants Analyzed reflects participants who had data available prior to study termination.||nmol/mmol creatinine||Standard Deviation|Median
165020|NCT00216060|Secondary|Time to Development of Hormone Refractory Disease||36 months|No data were collected for this Outcome Measure due to low accrual and subsequent study termination.|||||
165021|NCT00216060|Secondary|Rate of Patients Archiving a PSA (Prostate Specific Antigen) Nadir < 0.2 ng/mL||36 months|||percentage of participants|||Number
165022|NCT00216060|Primary|Numbers of SRE or Death Occurred Cumulatively|Number of participants experiencing a SRE(skeletal-related event) or death occurred, cumulative from each arm ( a daily oral dose of 30 mg risedronate, or placebo)|36 months|||participants|||Number
165023|NCT00215943|Secondary|Overall Survival (OS), by Treatment Arm|"Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive.~Investigators had planned to accrue 176 participants to calculate median overall survival."|Up to 10 Years|All participants with evaluable follow-up data.||months||Full Range|Median
165024|NCT00215943|Secondary|Number of Participants With Progression Free Survival (PFS), by Treatment Arm|"Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; > 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.~> 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation.~>25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium > 11.5 mg/dL not attributable to other causes)."|4 Months|All evaluable participants||participants|||Number
165025|NCT00215943|Secondary|Number of Participants With Adverse Events, by Group|Number of participants with toxicities of Thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed multiple myeloma (MM).|4 Years, 7 Months|All evaluable participants||participants|||Number
165026|NCT00215943|Primary|Response Rates of VAD vs. Thalidomide/Dexamethasone|Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart.|End of Cycle 4 - 4 Months per Participant|All evaluable participants||participants|||Number
165027|NCT00215930|Secondary|Progression Free Survival (PFS)|PFS was recorded as the time elapsed from the date of first treatment to the date of first evidence for disease progression or death. OS and PFS probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants for Number at risk, Number of events, Number censored.||Months||Full Range|Median
165028|NCT00215930|Secondary|Overall Survival (OS)|Median Overall Survival of Participants. OS and Progression Free Survival (PFS) probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes.|24 Months|Review of all participants per protocol for Number at risk, Number of events, Number censored.||Months||Full Range|Median
165029|NCT00215930|Primary|Best Disease Response After a Maximum of Six Cycles.|Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy.|24 Months|All participants were analyzed according to Response Evaluation Criteria in Solid Tumors (RECIST).||Participants|||Number
165030|NCT00215787|Primary|Presence of Reflux in Patients With Polyposis|Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.|one year|||participants|||Number
165031|NCT00215683|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.||participants|||Number
165032|NCT00215683|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS12) and the extension study FE200486 CS12A.||participants|||Number
165033|NCT00215657|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).||participants|||Number
165034|NCT00215657|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A||participants|||Number
165035|NCT00215553|Secondary|Days in ICU|Number of days in ICU|Day 28|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."||days||Standard Deviation|Mean
165036|NCT00215553|Secondary|Mortality||Day 28|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."||participants|||Number
165037|NCT00215553|Primary|Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.||28 days|"In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen.~In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve.~Analyses conducted on Intent-to-Treat population (all enrolled subjects)."||participants|||Number
165038|NCT00215540|Secondary|Days in Hospital|The number of days spent in the hospital through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||days||Standard Deviation|Mean
165039|NCT00215540|Secondary|Incidence of Death or BPD at 28 Days|Death or BPD, defined as oxygen requirement at 28 days of life|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
165040|NCT00215540|Secondary|Area Under the Curve for Mean Arterial Pressure (MAP)|AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||arterial pressure (mm Hg)*hour||Standard Deviation|Mean
165041|NCT00215540|Secondary|Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||Percent O₂*hour||Standard Deviation|Mean
165042|NCT00215540|Secondary|Duration of Supplemental Oxygen|Number of days receiving supplemental oxygen through 36 weeks PMA|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||days||Standard Deviation|Mean
165043|NCT00215540|Secondary|Days Receiving Mechanical Ventilation (MV)|Number of days receiving mechanical ventilation|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||days||Standard Deviation|Mean
165044|NCT00215540|Secondary|BPD at 36 Weeks|BPD at 36 weeks PMA as determined by the need for supplemental oxygen|36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
165045|NCT00215540|Secondary|BPD at 28 Days|BPD at 28 days of life, as determined by the need for supplemental oxygen|28 days of life|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
165046|NCT00215540|Primary|All-cause Mortality||36 weeks PMA|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
165047|NCT00215540|Primary|Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks|Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age|36 weeks post-menstrual age (PMA)|A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)||participants|||Number
165129|NCT00211692|Primary|The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.|Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study|24 weeks after the end of treatment|Convenience sample for pilot trial. Analysis is intention to treat.||participants|||Number
165048|NCT00215150|Primary|Brief Social Phobia Scale(BSPS)|An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.|Baseline, 8 and 16 weeks|The number of participants evaluated in either phase is based on a last observation carried forward analysis requiring at least one visit completed in addition to the first timepoint.||units on a scale||Standard Deviation|Mean
165049|NCT00215137|Primary|Yale Brown Obsessive Compulsive Scale|The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.|Open Label Phase Baseline,Randomization Phase Baseline or Beginning|||units on a scale||Standard Deviation|Mean
165050|NCT00214201|Other Pre-specified|WBC|White Blood Cell count|36 months +/- 60 days|||K/ul||Standard Deviation|Mean
165051|NCT00214201|Secondary|Serum Creatinine at 36 Months (End of Study)||36 months +/- 60 days|||mg/dl||Standard Deviation|Mean
165052|NCT00214201|Primary|Number of Participants With Biopsy Proven Rejection||3 years|||participants|||Number
165053|NCT00214903|Primary|Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke)|Arterial thromboembolism (ATE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
165054|NCT00214903|Primary|Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism)|Venous thromboembolism (VTE) linked to the use of continuous combined HRT containing both drospirenone (DRSP) and estradiol (E2) or to other oral continuous combined HRT preparations.|within 8.5 years|The number of participants refers to the ITT study population. During the course of the study, women could for example stop hormonal treatment at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.||participants|Participants||Number
165055|NCT00214786|Secondary|The Quality of Life of the Recipients Measured With the RAND 36-item Short Form Health Survey|Averaged score in subscales of 'physical functioning', 'Role limitations due to emotional problems', 'energy/fatigue', 'emotional well-being', 'social functioning', 'pain' and 'general health' in the RAND 36-item short form health survey (SF-36). Full scale range is 0-100 for all subscales with 100 as the best outcome and 0 as the worst outcome.|12 months after transplantation|||Scores on a scale||Full Range|Median
165056|NCT00214786|Secondary|Morbidity Related to the Islet Cell Infusion|Number of participants who experienced serious adverse events related to islet cell infusion|12months after transplantation|||participant|||Number
165057|NCT00214786|Secondary|Morbidity Related to the Immunosuppression Regimen|Number of participants who experienced serious adverse events related to immunosuppression regimen|12 months after transplantation|||participant|||Number
165058|NCT00214786|Secondary|Renal Function|Glomerular filtration rate measured by sodium iothalamate I-125 injection (GLOFIL)|12 months after transplantation|||ml/min||Standard Error|Mean
165059|NCT00214786|Secondary|The Number of Islet Cell Infusions Needed to Achieve Insulin Independence||12 months after transplantation|||number of infusion||Standard Error|Mean
165060|NCT00214786|Secondary|Islet Cell Mass Obtained After Remote Site Processing|The sum of Islet mass obtained after transport using the two-layer preservation method, remote site processing and islet culture. Islet mass as defined by Islet Equivalent per kilogram recipient body weight.|At transplantation|||Islet Equivalent per kilogram||Standard Error|Mean
165061|NCT00214786|Secondary|Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent|Percentage of insulin requirement at month 12 against that at baseline in the patients who did not achieve insulin independence. The percentage less than 100% indicates that subjects reduced insulin requirements 12 months after islet transplantation when compared with those at pre-transplant, while the parentage more than 100% represents that patients needed higher amount of exogenous insulin 12 months after islet transplantation.|12 months after transplantation|||Percent decrease compared to baseline||Standard Error|Mean
165062|NCT00214786|Secondary|Incidence of Hypoglycemic Episodes|Blood glucose <70 mg/dl, number of times reported per month|12 months after transplantation|||episodes per month||Standard Error|Mean
165063|NCT00214786|Secondary|Presence or Absence of Hypoglycemic Unawareness|Number of patients who achieved absence of hypoglycemic unawareness|12 months after transplantation|||participants|||Number
165064|NCT00214786|Primary|Achievement of Insulin Independence at 12-month Post Transplant|To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation|12 months post transplant|||participant|||Number
165065|NCT00214539|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Quality of Life Questionnaire (AQLQ) score. The AQLQ is a self-administered patient questionnaire that assesses four aspects or domains of daily life for patients with asthma: symptoms, emotional function, activity limitations, and environmental stimuli. The AQLQ is based on a 2-week recall period and consists of 32 questions, each scored from 1 (Worse) to 7 (Better). An increase in the AQLQ score indicates a better quality of life.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
165066|NCT00214539|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Control Questionnaire (ACQ) score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). The ACQ is based on a one-week recall period. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
165130|NCT00211237|Secondary|Radiographic: Rate of Subsequent Vertebral Body Fractures (as Assessed by Independent Radiologists at the Core Laboratory)||Baseline, Pre-op, Post-Op, 1 Month and 12 Month||||||
165067|NCT00214539|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
165068|NCT00214539|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
165069|NCT00214539|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Total Symptom Score. The Total Symptom Score comprises the sum of six asthma symptom measurements recorded in a Daily Diary. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom Score represents better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
165070|NCT00214539|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in use of rescue medications. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.|Baseline, 12 Months|||Puffs/7 Days||Standard Deviation|Mean
165071|NCT00214539|Secondary|Use of Maintenance Medications (Change From Baseline)|Percent Change from Baseline at 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visit in dose of inhaled and/or oral corticosteroids.|Baseline, 12 Months|||Percent||Standard Deviation|Mean
165072|NCT00214539|Primary|Respiratory Adverse Events Per Subject|Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.|Baseline, 12 Months|||Respiratory Adverse Events/Subject|||Number
165073|NCT00214526|Secondary|Total Symptom Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
165074|NCT00214526|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID).|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
165075|NCT00214526|Secondary|Use of Maintenance Medications (Change From Baseline)|Change from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists).|Baseline, 12 Months|||Subjects|||Number
165076|NCT00214526|Secondary|Use of Rescue Medications (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study.|Baseline, 12 Months|||Puffs/7 Days||Standard Deviation|Mean
165077|NCT00214526|Secondary|Asthma Control Questionnaire (ACQ) Score (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient’s asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control.|Baseline, 12 Months|||Units on a scale||Standard Deviation|Mean
165078|NCT00214526|Secondary|Peak Expiratory Flow (Morning and Evening) (Change From Baseline)|Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air.|Baseline, 12 Months|||L/min||Standard Deviation|Mean
165079|NCT00214526|Secondary|Methacholine PC20 (Change From Baseline)|"Change from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in PC20 - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more “responsive” or “hyperresponsive” the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive."|Baseline, 12 Months|||mg/mL||95% Confidence Interval|Geometric Mean
165080|NCT00214526|Secondary|Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
165081|NCT00214526|Secondary|Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)|Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).|Baseline, 12 Months|||Percent Change||Standard Deviation|Mean
165131|NCT00211237|Secondary|Radiographic: Change in Spinal Deformity, Defined as the Degree of Spine Angulation (as Assessed by an Independent Radiologist at the Core Laboratory)||Baseline, Pre-op, Post-Op, 1 Month and 12 Month||||||
165082|NCT00214526|Primary|Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)|Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.|Baseline, 12 Months|||Exacerbations/Subject/Week||Standard Deviation|Mean
165083|NCT00214487|Secondary|Changes in Axial Length at One Year.||One year||||||
165084|NCT00214487|Secondary|Changes in Cycloplegic Subjective Refraction in One Year||One year||||||
165085|NCT00214487|Secondary|Relationship Between Residual Fixation Disparity and Myopia Progression.||One year||||||
165086|NCT00214487|Secondary|Changes in Manifest Refraction at One Year.||One year||||||
165087|NCT00214487|Secondary|Keratometric Changes at One Year.||One year||||||
165088|NCT00214487|Primary|Changes in Cycloplegic Autorefraction in One Year.||One year|||Diopters||Standard Deviation|Mean
165089|NCT00214461|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post first vaccination|Safety assessments were on the safety population.||Participants|||Number
165090|NCT00214461|Secondary|Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.|Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject’s specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).|Day up to Day 236 post first vaccination|Serum anti-toxin levels were assessed in the fully evaluable (Per-Protocol) population.||Participants|||Number
165091|NCT00214383|Secondary|Improvement in Asthma Control|A six item survey on a seven point Likert scale measuring daytime and nocturnal asthma symptoms, missed school days and rescue medication use in the previous seven days. Lower scores signal better asthma control.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.||Likert scale||95% Confidence Interval|Mean
165092|NCT00214383|Primary|Number of Symptom-free Days|A comparison in the average number of days that a child goes without asthma symptoms between experimental and control groups are shown below.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.||Days||95% Confidence Interval|Mean
165093|NCT00214383|Primary|Percentage Changed in Adherence Score|A baseline number of participants less dropouts was gauged against the weighted average of the number of participants in study period. The percentage change in adherence from baseline through the study was measured and is reported below, together with confidence intervals.|Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores|Forty two dyads dropped out after randomization. Of these, 16 were from the experimental group and 26 from the control group.||Percent change||95% Confidence Interval|Mean
165094|NCT00214019|Primary|Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge|Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.|Eosinophils are measured 24 hours after the subject has an antigen challenge|Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases.||Eosinophil percentage||Standard Deviation|Mean
165095|NCT00213135|Secondary|Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan|Mean Number of CU lesions, active T2 lesions, and active T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all participants who were randomized in the study.||lesions||Standard Error|Least Squares Mean
165096|NCT00213135|Secondary|Time to Disability Progression|Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Tenth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.|Baseline up to Week 96|The ITT population included all participants who were randomized in the study.||months|||Number
165097|NCT00213135|Secondary|Percentage of Relapse-free Participants|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the EDSS or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Week 96|The ITT population included all participants who were randomized in the study.||percentage of participants|||Number
165098|NCT00213135|Primary|Annualized Qualifying Relapse Rate|A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.|Week 96|The intention-to-treat (ITT) population included all participants who were randomized in the study.||relapses per year||95% Confidence Interval|Number
165132|NCT00211237|Secondary|Change in Back Pain (as Measured by a 10-point Numerical Rating Scale)||Baseline, 7-10 Day Phone Call, 1 Month, 3 Month, 6 Month and 12 Month||||||
165099|NCT00211536|Secondary|Low Blood Glucose Index (LBGI);|4 to 10 daily blood glucose readings (BG) were required for this measure. LBGI was calculated from BG values collected for 30 days prior to Visit 2 and 30 days following Visits 5 and 7. The continuous measure was compared between the two treatment groups for the three periods with a repeated measures ANOVA using proc mixed. Type 3 least square means for each group were assessed and estimate statements used to make comparisons among the LS means and create confidence intervals on the contrasts.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||mg/dL||95% Confidence Interval|Mean
165100|NCT00211536|Secondary|Mean Amplitude of Glycemic Excursions (MAGE)|MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||mg/dL||95% Confidence Interval|Mean
165101|NCT00211536|Secondary|Average Daily Blood Glucose|For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.|average from baseline to 12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||mg/dL||95% Confidence Interval|Mean
165102|NCT00211536|Primary|Incidence of Severe Hypoglycemia Events|The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months.|12 months|The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.||events|||Number
165103|NCT00211536|Primary|Change in HbA1c and Compared Between Groups|To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts.|Baseline and 12 months|The primary efficacy analysis set is the As treated data set and includes all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values.||percent HbA1c||Standard Deviation|Mean
165104|NCT00211510|Secondary|Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups|Questionnaire evaluating subjects'potential fear of hypoglycemia events. Change assessed at Baseline and Week 26 and compared between groups. Likert scale scored with 4 being the worst and 0 being no problem.|Baseline and 26 weeks|||Scores on a scale||Standard Deviation|Mean
165105|NCT00211510|Secondary|Glucose Sensor Accuracy as Measured in the 722 Group|Percent comparative sensor glucose reading to blood glucose meter in agreement within +/- 20% (Clark Error Grid zone A + zone B).|Baseline and 26 weeks|||percent of agreement|||Number
165106|NCT00211510|Secondary|Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks|||mmol/dl*min||Standard Deviation|Mean
165107|NCT00211510|Secondary|Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26|Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 26|Baseline and 26 weeks|||mmol/dl*min||Standard Deviation|Mean
165108|NCT00211510|Secondary|Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26|Severe Hypoglycemia as defined by hypoglycemic events requiring the assistance of another person to actively administer carbohydrates, glucagon or other resuscitative actions, as reported by subject. The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 26.|Baseline and 26 weeks|||hypoglycemic events|||Number
165109|NCT00211510|Primary|Change in A1c From Baseline to 26 Weeks|Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.|Baseline and 26 weeks|||Percent glycated hemoglobin||Standard Deviation|Mean
165110|NCT00212758|Secondary|Change in Height at 56 Weeks||week 1, week 56|||cm||Standard Deviation|Mean
165111|NCT00212758|Primary|The Change in Amount of Insulin Like Growth Factor (IGF-I) Generated (Day 8-day 1)|We will measure the amount of serum IGF-I generated after 7 days of growth hormone therapy (Day8-Day1).|Day 1 & Day 8|||mcg/L||Standard Deviation|Mean
165112|NCT00212355|Primary|Safety|No of patients who have at least one adverse events.|During study period (up to 96W )|The analysis was performed based on FAS population||participants|||Number
165133|NCT00211237|Secondary|Change in Quality of Life (as Assessed by the SF-36v2™ Health Survey)||Baseline, 1 Month, 3 Month, 6 Month and 12 Month||||||
165113|NCT00212264|Primary|Percent Change in Incontinence Episodes Per Week on Bladder Diary|[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%|1 year|This outcome was to measure treatment durability. The no-treatment control group completed the study after the primary outcome was collected at 2 months. At that time, they were offered treatment for this burdensome condition outside the study. Only the 2 active treatment groups continued in the study for 1 full year.||% change in episodes per week||95% Confidence Interval|Mean
165114|NCT00212264|Primary|Percent Change in Incontinence Episodes on Bladder Diary|[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%|2 months|||% change in episodes per week||95% Confidence Interval|Mean
165115|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252|Phase 1 - Age 12 Months|All those who completed the PSI 3 months after surgery and the PSI at age 12 months||units on a scale||Standard Deviation|Mean
165116|NCT00212134|Secondary|Adherence to Occlusion Therapy|Parental report of the number of hours children wore an patch to occlude the fellow eye.|Phase 1 - 12 months follow-up|Analysis is limited to those with at least 3 reports of adherence before 12 months of age.||Hours patched per day||Standard Deviation|Mean
165117|NCT00212134|Secondary|Parenting Stress|The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.|Phase 1 - 3 months post surgery|All those who completed the PSI 3 months after surgery.||units on a scale||Standard Deviation|Mean
165118|NCT00212134|Secondary|Percent of Patients With 1 or More Adverse Events||Study enrollment to age 5 years|||percentage of patients||95% Confidence Interval|Number
165119|NCT00212134|Primary|Visual Acuity - Subjective Assessment at Age 4.5 Years.|Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.|Phase 2 - Age 4.5 Years|One patient in the intraocular lens group was lost to follow-up.at age 18 months. A second patient in that group had developmental delay and the visual acuity could not be assessed. Therefore, the visual acuity measurements at 4.5 years of age are reported for 55 of the 57 patients randomized to the intraocular lens group.||logMAR units||Inter-Quartile Range|Median
165120|NCT00212134|Secondary|Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery||Cataract surgery immediately after enrollment|||percentage of patients||95% Confidence Interval|Number
165121|NCT00212134|Primary|Visual Acuity|Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.|Phase 1 - Age 12 months|The number of participants was determined by the sample size estimate necessary to detect a 0.2 logMAR difference (2 lines on the Snellen chart) in the visual acuity between the two groups.||logMAR units||Inter-Quartile Range|Median
165122|NCT00211887|Secondary|Change in MRI Composite Score|MRI composite score (Z4 score) - the unweighted sum of the individual Z scores for enhanced tissue volume, T2 lesion burden, equivalence of the T1 hypointense lesion burden, normalized CSF (an inverse measure of atrophy with the appropriate sign so that all scores are directionally compatible – larger is worse) MRI enhancement status at baseline (0, 1-4, and 5 or more enhancing lesions)|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.||z score||Standard Deviation|Mean
165123|NCT00211887|Secondary|Change in the Multiple Sclerosis Functional Composite|"positive indicates improvement~The Multiple Sclerosis Functional Composite (MSFC) is a scale measuring pyramidal functions, sensory functions, cerebellar functions, bowel & bladder functions,brain stem functions, mental functions, and visual functions from 0 to 6.~0= normal 6= severe loss"|Baseline to month 36|Due to participant dropouts, there were less participants analyzed for this particular outcome measure.||units on a scale||Full Range|Median
165124|NCT00211887|Secondary|Confirmed Progression on the Expanded Disability Status Scale|"% with EDSS progression~Confirmed progression in a participant was defined as a 1.0 increase in the EDSS from baseline, when baseline <=5.0; or an increase of 0.5 from baseline, when baseline >=5.5, sustained for 6 months (2 successive quarterly visits), as assessed by the blinded EDSS examiner and confirmed centrally."|Baseline to Month 36|||percentage of participants|||Number
165125|NCT00211887|Primary|ARR - PDEs|Annualized relapse rate of protocol-defined exacerbations Protocol defined relapse – an relapse seen within 7 days of onset, verified by the treating physician and independently observed as a change in EDSS by the examining physician. This relapse is defined as: the appearance of a new symptom or worsening of an old symptom, attributable to MS; accompanied by a change in the neurologic examination (defined as a 0.5 or greater increase in the EDSS over the last scheduled or unscheduled visit or a 2 point change in one functional system or a 1 point change in two functional systems, except bladder and cognitive changes); lasting at least 24 hours in the absence of fever; and preceded by stability or improvement for at least 30 days.|Baseline to Month 36|||relapses per year|||Number
165126|NCT00211692|Secondary|Overall Number of Serious Adverse Events||through end of study up to 72 weeks|||participants|||Number
165134|NCT00211237|Secondary|Clinical: Change in Functional Status (as Assessed With the Roland-Morris Disability Questionnaire and the Karnofsky Performance Scale)||Baseline, 1 Month , 3 Month, 6 Month and 12 Month||||||
165136|NCT00211237|Primary|The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month|"The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain.~The best score is 0 (no disability) and worst is 24 (maximum disability)"|Baseline and 1 Month|||score on a scale||95% Confidence Interval|Mean
165137|NCT00211172|Primary|Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date|The primary outcome measure adherence to B-blocker therapy post intervention. Adherence was measured by the degree of prescription filling in an interval derived from pharmacy prescription records by constructing a proportion-of-days-covered per-month measure, using the quantity dispensed and days supplied from each prescription|9 months|||Adjusted monthly % of days covered||Standard Deviation|Mean
165138|NCT00211081|Primary|Change in Flow Mediated Dilation|Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.|Baseline, 4 weeks|||Percentage of brachial artery diameter||Standard Deviation|Mean
165139|NCT00211081|Secondary|Drawn and Conducted at Baseline and 4-5 Weeks After Initial Study.||baseline and 4-5 weeks after initial study||||||
165140|NCT00211081|Secondary|Change in 6 Minute Walk Test||performed at first and last visit to determine toleration of daily activity||||||
165141|NCT00211081|Secondary|Change in Cytotkine Panels||drawn at baseline and 4-5 week visit||||||
165142|NCT00211081|Secondary|Change in TNF Alpha||drawn at baseline and 4-5 week visit||||||
165143|NCT00211081|Secondary|Change in Form Assay||drawn at baseline and 4-5 week visit||||||
165144|NCT00211081|Secondary|Change in BNP||drawn at baseline and 4-5 week visit||||||
165145|NCT00210639|Primary|Musculoskeletal Adverse Events During the Musculoskeletal Disorder Follow-up Phase|The criteria used to assess Musculoskeletal Adverse Event is based on system organ class “Musculoskeletal and connective tissue disorders” of MedDRA 13.0.|Musculoskeletal Disorder (MSD) Follow-Up phase (ie, up to 5 years after their first dose of antimicrobial therapy, yearly visits for 4 additional years)|Participants (207) who were followed up during the MSD Follow-Up Phase.||Participants|||Number
165146|NCT00210626|Secondary|Return to Usual Activity (RTUA)|Number of Subjects with Week 24 SF-36 PF Score greater than or equal to their pre-trauma SF-36 PF score. The pre-trauma SF-36 PF score was collected at hosptital discharge and reflects a subjects physical function before they were injured and hospitalized.|Hospital Discharge to Post-Hospital Discharge Week 24|Intention to Treat(ITT)population and completed Week 24 Post-Hospital discharge.||Participants|||Number
165147|NCT00210626|Primary|SF-36 PF Score|Average SF-36 (Medical Outcome Survey Short Form) PF (Physical Function) Score post hospital discharge for each subject. Each subjects SF-36 score is the average of all the post hospital discharge scores. The SF-36 score is a patient reported questionaire related to Physical Function base the score can range from 0 to 100. The worst score is 0 and the best possible score is 100.|Hospital Discharge to Post-Hospital Discharge Week 24|ITT (Intent to Treat), The number of subjects analyzed includes all ITT subjects that did not withdraw from the study prior to hospital discharge.||Units on a scale.||Standard Deviation|Mean
165148|NCT00210470|Secondary|Correlation of Tumor Response or Immune Competence (Lymphocyte Infiltration) With Disease-Free Survival or Overall Survival|Investigate whether clinical or histological tumor response or improvement in immune competence correlate with DFS and OS|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||09/2012||||
165149|NCT00210470|Secondary|Overall Survival|Estimate overall survival (OS) in patients receiving the IRX-2 regimen|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||09/2012||||
165150|NCT00210470|Secondary|Disease-free Survival|Estimate disease-free survival (DFS) (defined as time from cyclophosphamide administration and time from surgery to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy; margins of resection positive for tumor will not be considered disease recurrence)|Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease||09/2012||||
165151|NCT00210470|Secondary|Immune Competence as Measured by Lymphocyte Infiltration|To assess measures of immune competence following administration of the IRX-2 regimen, including total lymphocyte count, peripheral T-cell count and subpopulation studies, and skin test reactivity|At approx. 21 days, prior to surgery||09/2012||||
165152|NCT00210470|Secondary|Evaluate Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;||Following surgery and post-operative therapy||09/2012||||
165153|NCT00210470|Secondary|Clinical and Histological Tumor Responses||At approx. 21 days, prior to surgery||09/2012||||
165154|NCT00210470|Primary|Number of Participants With Adverse Events and Serious Adverse Events|The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described. The number of deaths during study and their relatedness (or not) to treatment, as well as changes in laboratory measures, were published (see referenced publication for details: Wolf, 2011).|Enrollment through 30 days post-surgery|"27 participants were entered into study and treated. All participants were included in the safety analysis.~Based on safety results, the treatment regimen was tolerated. Further clinical study was recommended to evaluate efficacy."||participants|||Number
165155|NCT00209560|Secondary|Time to Fully Alert From the End of the Procedure|Time to Fully Alert, defined as the time to the first of 3 consecutive Modified OAA/S scores of 5 from the end of the surgical procedure, was summarized.|At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status|The primary analysis for the secondary efficacy endpoint was based on the mITT population. Missing values or incomplete data were not imputed.||minutes||Standard Deviation|Mean
165169|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
165170|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
165390|NCT00205881|Secondary|HINT Sentences in Noise|20 sentences presented in noise at fixed levels|8 months of bilateral cochlear implant use||||||
165156|NCT00209560|Primary|Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation|"The Modified OAA/S (MOAA/S) scale is based on a validated, 6-point rating scale. Scores are not combined.~Score 5 (alert) -- responds readily to name spoken in normal tone Score 4 -- Lethargic response to name spoken in normal tone Score 3 -- Responds only after name is called loudly and/or repeatedly Score 2 -- Responds only after mild prodding or shaking Score 1 -- Responds only after painful trapezius squeeze Score 0 -- Does not respond to painful trapezius squeeze"|Sedation success was assessed at 2 minute intervals until the end of the procedure|The pP1 and mITT population included all subjects randomized,received either fospropofol disodium or midazolam, had at least 1 postdose clinical assessment, and were not terminated due to the Investigator’s decision for nonstudy drug related findings. A 95% confidence interval for the sedation success rate was calculated for each treatment group.||participants||95% Confidence Interval|Number
165157|NCT00209417|Secondary|Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.|"Overall Image Quality rated as Excellent, Good, Sufficient or Insufficient Poor by radiologists blinded to the contrast administration."|Within 2, 3 and 7 days post contrast administration.|||Number of images|Participants||Number
165158|NCT00209417|Primary|Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.|"The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL).~Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction."|From baseline up to 3 days post contrast administration.|To calculate the incidence rate of CIN, divide the number of subjects affected by the total number of subjects dosed in each treatment group.||percentage of subjects||95% Confidence Interval|Number
165159|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|60 months|"NYHA functional class was evaluated in 15 patients at the 48-month follow-up visit. NYHA assessment is missing in 40 patients due to:~30 withdrawals~4 deaths~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165160|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|48 months|"NYHA functional class was evaluated in 19 patients at the 48-month follow-up visit. NYHA assessment is missing in 36 patients due to:~23 withdrawals~3 deaths~1 missed visit~3 NYHA assessments not done~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165161|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 months|"NYHA functional class was evaluated in 21 patients at the 36-month follow-up visit. NYHA assessment is missing in 34 patients due to:~19 withdrawals~2 deaths~3 missed visits~4 NYHA assessments not done~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165171|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
165172|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
165173|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
165162|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|"NYHA functional class was evaluated in 28 patients at the 24-month follow-up visit. NYHA assessment is missing in 27 patients due to:~18 withdrawals~2 deaths~1 missed visit~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165163|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|18 months|"NYHA functional class was evaluated in 27 patients at the 18-month follow-up visit. NYHA assessment is missing in 28 patients due to:~15 withdrawals~2 deaths~5 missed visits~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165164|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|"NYHA functional class was evaluated in 39 patients at the 12-month follow-up visit. NYHA assessment is missing in 16 patients due to:~8 withdrawals~1 death~NYHA assessment not done in 1 patient~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165165|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|"NYHA functional class was evaluated in 47 patients at the 30-day follow-up visit. NYHA assessment is missing in 8 patients due to:~2 withdrawals~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165166|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months|"NYHA functional class was evaluated in 41 patients at the 6-month follow-up visit. NYHA assessment is missing in 14 patients due to:~7 withdrawals~1 death~As per the protocol, the 6 patients not implanted with the MitraClip were not required to attend follow-up visits."||participants|||Number
165167|NCT00209339|Secondary|New York Heart Association (NYHA) Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|Baseline|||participants|||Number
165168|NCT00209339|Secondary|Cardiac Index|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min/m^2||95% Confidence Interval|Mean
165174|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
165175|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
165176|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
165177|NCT00209339|Secondary|Cardiac Output|Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||L/min||95% Confidence Interval|Mean
165178|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
165179|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
165180|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
165181|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
165182|NCT00209339|Secondary|Mitral Valve Gradient|Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||mmHg||95% Confidence Interval|Mean
165183|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165184|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165185|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165186|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT~PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165187|NCT00209339|Secondary|Mitral Valve Area (MVA) by Pressure Half-Time|"The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method.~The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography."|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165188|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165189|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165190|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165191|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165192|NCT00209339|Secondary|Mitral Valve Area - Single Orifice|Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||cm^2||95% Confidence Interval|Mean
165193|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165194|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165195|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165196|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165197|NCT00209339|Secondary|Left Ventricular End Systolic Volume|Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165198|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|60 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165199|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|24 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165200|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|12 months|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165201|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|During the hospital stay with a maximum of 3 days post index procedure (Discharge)|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165202|NCT00209339|Secondary|Left Ventricular End Diastolic Volume|Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|Baseline|Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done.||Milliliter||95% Confidence Interval|Mean
165206|NCT00209339|Secondary|Major Vascular and Bleeding Complications|Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure|Through 30 days|||percentage of participants|||Number
165207|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 5 years|||Percentage of participants||95% Confidence Interval|Number
165208|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 4 years|||Percentage of participants||95% Confidence Interval|Number
165209|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 3 years|||Percentage of participants||95% Confidence Interval|Number
165210|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 24 months|||Percentage of participants||95% Confidence Interval|Number
165211|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||At 12 months|||Percentage of participants||95% Confidence Interval|Number
165212|NCT00209339|Secondary|Death (Kaplan-Meier Freedom From Death)||Within 30 days of the procedure|||Percentage of participants|||Number
165213|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 5 Years|||Percentage of participants||95% Confidence Interval|Number
165214|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 4 Years|||Percentage of participants||95% Confidence Interval|Number
165215|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 3 Years|||Percentage of participants||95% Confidence Interval|Number
165216|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 24 months|||Percentage of participants||95% Confidence Interval|Number
165217|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At 12 months|||Percentage of participants||95% Confidence Interval|Number
165218|NCT00209339|Secondary|Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)|Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure.|At baseline|||Percentage of participants|||Number
165219|NCT00209339|Secondary|MitraClip Device Embolizations and Single Leaflet Device Attachment|MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device.|Post index procedure through 5 years|Of the 55 patients enrolled in the EVEREST I study, 6 patients did not have a MitraClip device implanted.||Participants|||Number
165220|NCT00209339|Secondary|Second Intervention to Place a Second MitraClip Device||Post index procedure through 5 years|||Participants|||Number
165221|NCT00209339|Secondary|Post-procedure Hospital Stay||Post-index procedure until hospital discharge (1 to 19 days)|||Days||Standard Deviation|Mean
165222|NCT00209339|Secondary|Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration||Post index procedure within 30 days|||Hours||Standard Deviation|Mean
165223|NCT00209339|Secondary|Intra-procedural Major Adverse Events|Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure|At day 0 (on the day of index procedure)|||percentage of participants|||Number
165224|NCT00209339|Secondary|Number of Mitraclip Devices Implanted||At day 0 (on the day of index procedure)|||Percentage of participants|||Number
165225|NCT00209339|Secondary|Fluoroscopy Duration|Mean fluoroscopy duration during the MitraClip procedure.|At day 0 (on the day of index procedure)|Mean fluoroscopy duration was not recorded in one patient. Therefore, mean fluoroscopy data is available for 54 of the 55 patients.||Minutes||Standard Deviation|Mean
165226|NCT00209339|Secondary|Contrast Volume|Mean contrast volume utilized during the MitraClip procedure.|At day 0 (on the day of index procedure)|Contrast volume was not recorded in one patient. Therefore, contrast volume data is available for 54 of the 55 patients.||Milliliters||Standard Deviation|Mean
165227|NCT00209339|Secondary|Device Time|Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC.|At day 0 (on the day of index procedure)|||Minutes||Standard Deviation|Mean
165228|NCT00209339|Secondary|Procedure Time|"Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours.~The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device."|At day 0 (on the day of index procedure)|||Minutes||Standard Deviation|Mean
165229|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 6 Months|||Percentage of participants|||Number
165230|NCT00209339|Primary|Major Adverse Events (MAE)|Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia.|Through 30 days|||Percentage of participants|||Number
165231|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 5 years|Of total 55 patients population 15 patients were analysed, as 40 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
165232|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 4 years|Of total 55 patients population 19 patients were analysed, as for 4 patients Echocardiogram was not performed and 32 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
165233|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 3 years|Of total 55 patients population 23 patients were analysed, as for 5 patients Echocardiogram was not performed and 27 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
165234|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 24 months|Of total 55 patients population 28 patients were analysed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
165235|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At 12 months|Of total 55 patients population 39 patients were analyzed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up.||Percentage of participants|||Number
165236|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At discharge or within 30 days of the procedure|Based on the number of patients who have not died or withdrawn, and have reached the scheduled visit window||Percentage of participants|||Number
165237|NCT00209339|Primary|Mitral Regurgitation Severity|All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL).|At baseline|Of total 55 patients,for 1 patient Echocardiogram was not evaluable.||Percentage of participants|||Number
165238|NCT00209170|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24|"The 21-item HDRS measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60, where higher scores indicate greater severity. The HDRS at week 24 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder =< 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, week 24|Last Observation Carried Forward||participants|||Number
165239|NCT00209131|Secondary|Medical Evaluation|Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures.|2 weeks and 3 months||||||
165240|NCT00209131|Primary|Time to Passage of Stone Fragments|Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging.|2 weeks and 3 months|No analysis was conducted.|||||
165241|NCT00209092|Secondary|Long Term Follow up Data on Recurrence and Survival|Number of Patients remained alive and relapse free|2 years|||participants|||Number
165242|NCT00209092|Primary|Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.|"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.~Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%)~Stable disease (SD): No decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions.~Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site."|1 year|||participants|||Number
165243|NCT00209027|Primary|BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task|fMRI BOLD activation during a reward task will be compared between schizophrenia subjects and controls at Baseline. Schizophrenia subjects will switch their baseline medication to aripiprazole and their BOLD activation during the reward task at Baseline will be compared to the endpoint scan.|Baseline and 12 weeks|Prespecified data not collected because the study was terminated before subjects received aripiprazole.|||||
165244|NCT00208975|Primary|Number of Patients's Who Had Complete Response and Partial Response to the Treatment of Fludarabine and Cyclophosphamide Followed by GM-CSF and Rituximab.|"Complete Response (CR): Disappearance of all clinical evidence of active tumor for a minimum of eight weeks and absence of any symptoms related to the tumor.~Partial Response (PR):50% decrease in the sum of the product diameters of all lesions that persist for at least four weeks. No lesion can increase in size and no new lesion can appear during this period.~Stable disease (SD):A tumor that is neither growing nor shrinking.No new tumors have developed"|6 months|||participants|||Number
165245|NCT00208949|Secondary|Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.|Median overall survival|5 years|||months||Full Range|Median
165246|NCT00208949|Primary|Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft||at transplant (1 day)|Sample size determinations for this randomized trial were based on a baseline frequency of mDCs(myeloid dendritic cells) and pDCs( plasmacytoid dendritic cells)within the peripheral blood of 0.5% with a SD equal to the mean (0.5%).||x10 ^ 6 cells/kg||Standard Error|Median
165247|NCT00208767|Primary|Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years|The PI will measure carotid artery thickening with magnetic resonance imaging.|Baseline, 2 years|||mm2||Standard Deviation|Mean
165248|NCT00208507|Secondary|Complication Rates||On-going to end of study||||||
165249|NCT00208507|Primary|Harris Hip Total Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.|6 weeks, 6, 12 months and last follow up at 24 months or greater|||Units on a scale||Standard Deviation|Mean
165250|NCT00208494|Primary|Composite Success/Failure|The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.|At 24 months|Out of the 390 subjects, 84 subjects were removed from the analysis for the following reasons: 2 deaths (1 in each arm); 3 protocol violations (2 COM, 1 MOM); 28 bilateral (12 COM, 16 MOM); 39 subjects had no 24-month Harris Hip score (22 COM, 17 MOM); and 12 subjects had no 24-month x-ray (4 COM, 8 MOM).||Participants|||Number
165251|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 62 subjects in the PFC Sigma Fixed Bearing and 60 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165252|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 60 subjects in the PFC Sigma Fixed Bearing and 62 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165253|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 77 subjects in the PFC Sigma Fixed Bearing and 70 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165254|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 75 subjects in the PFC Sigma Fixed Bearing and 71 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165255|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165256|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165257|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165258|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165259|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165260|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165261|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165262|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165263|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants||95% Confidence Interval|Number
165264|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants||95% Confidence Interval|Number
165265|NCT00208325|Secondary|To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.|2 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants||95% Confidence Interval|Number
165479|NCT00205504|Secondary|Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women|The lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).|Baseline and 6 months|||mg/dL||Standard Deviation|Mean
165266|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165267|NCT00208325|Secondary|To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.|Operative|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165268|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165269|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165270|NCT00208325|Secondary|To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165271|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 122 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165272|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 153 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165273|NCT00208325|Secondary|To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 141 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165274|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165275|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165276|NCT00208325|Secondary|To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165277|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165278|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165279|NCT00208325|Secondary|To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165280|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165281|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165282|NCT00208325|Secondary|To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165283|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|5 Years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165284|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165285|NCT00208325|Secondary|To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.|2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||percentage of participants|||Number
165286|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 124 subjects in the PFC Sigma Fixed Bearing and 125 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165287|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 146 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165288|NCT00208325|Secondary|To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 155 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165289|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 120 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165290|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165391|NCT00205881|Primary|Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.|Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.|8 months of bilateral cochlear implant use|Adults with severe-to-profound hearing loss who received bilateral cochlear implants in the same operation.||percent of words correct||Standard Deviation|Mean
165291|NCT00208325|Secondary|To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165292|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 114 subjects in the PFC Sigma Fixed Bearing and 111 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165293|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 134 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165294|NCT00208325|Secondary|To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 145 subjects in the PFC Sigma Fixed Bearing and 138 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||units on a scale||Standard Deviation|Mean
165295|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 5 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 123 subjects in the PFC Sigma Fixed Bearing and 124 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
165296|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
165297|NCT00208325|Secondary|To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 2 years|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 156 subjects in the PFC Sigma Fixed Bearing and 148 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
165298|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 153 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
165299|NCT00208325|Primary|To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|Change from pre-op to 1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 164 subjects in the PFC Sigma Fixed Bearing and 164 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
165480|NCT00205504|Primary|Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women|Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).|Baseline and 6 months|||mIU/L||Standard Deviation|Mean
165481|NCT00205049|Primary|Survival at 28 Days||28 days|Study was terminated before any data was gathered/analyzed.|||||
165300|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 155 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
165301|NCT00208325|Primary|To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 168 subjects in the PFC Sigma Fixed Bearing and 167 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.||degrees||Standard Deviation|Mean
165302|NCT00208091|Secondary|Subjective Assessment Ratings of Change|Each subject assessed his or her music playing performance change subjectively from -100 percent (fully worse) to 100 percent (fully better).|Baseline to 6 weeks after injection|||percentage change||Standard Deviation|Mean
165303|NCT00208091|Primary|Note Errors (Related to Errors in Loudness)|Note errors (related to errors in loudness) were obtained as a measure of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note loudness data (decibels) from four musical sequences of 8 to 16 notes. It was calculated by averaging sequences for each hand and taking the square root of the mean of the square of the differences (root mean square error, in decibels) in MIDI notes.|Baseline and 6 weeks post-injection|||decibels||Standard Error|Median
165304|NCT00208091|Primary|Note Errors (Related to Errors in Duration)|Note errors (related to errors in duration in msec) were obtained as measures of difference between the affected and unaffected hands--taking the musical instrument digital interface (MIDI) note output from four musical sequences of 8 to 16 notes played. It was calculated by averaging the sequences for each hand, and deriving the square root of the mean of the square of the differences (root mean square error, in msec) in MIDI.|Baseline and 6 weeks post-injection|||msec||Standard Error|Median
165305|NCT00208026|Secondary|Liver Function Tests||Each visit||||||
165306|NCT00208026|Secondary|Blood Urea Nitrogen and Creatinine||Each visit||||||
165307|NCT00208026|Secondary|Blood Electrolytes and Fasting Glucose||Each visit||||||
165308|NCT00208026|Secondary|Complete Blood Count With Differential||Each visit||||||
165309|NCT00208026|Primary|Transepidermal Water Loss||Each visit||||||
165310|NCT00208026|Primary|Pruritus Severity Assessment||Each visit||||||
165311|NCT00208026|Primary|Investigator's Global Evaluation of Disease (IGED)||Each visit||||||
165312|NCT00208026|Primary|Netherton Area and Severity Assessment (NASA)||Each visit||||||
165313|NCT00208026|Primary|Eczema Area and Severity Index (EASI)||Each visit||||||
165314|NCT00208026|Primary|Highest Peak Blood Concentration of Pimecrolimus Over All Study Visits|At each scheduled visit, blood concentration of pimecrolimus were obtained. This value reflects the amount of pimecrolimus in the blood. This is measured directly from the blood and provides an estimate of the degree of absorption of the treatment medication through the skin into the blood. Analysis was performed as intent-to-treat with last value carried forward, but no data points were missing.|Each visit up to 18 months|Only the highest peak level documented for the group is reported||ng/mL|||Number
165315|NCT00207740|Secondary|Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects|The endpoint is the change from baseline in domiciliary morning PEFR at Week 24. PEFR— Peak Expiratory Flow Rate (PEFR): A measure of the speed of exhalation. The data were collected in the eDiary which was issued to each participant at screening. PEFR was collected morning and evening each day of the study.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward (LOCF).||L/min||Standard Deviation|Mean
165316|NCT00207740|Secondary|Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline|The endpoint is the change from baseline at Week (Wk) 52 in oral corticosteroids (OCS) dose for the randomized patients who received OCS at baseline.|Baseline and Week 52|Analysis of this endpoint includes only pts who received OCS at baseline.Wk 52 OCS dose is the daily OCS dose in the last period, defined as between 2 consecutive visits, in which no change in total daily dose of OCS occurred, prior to Wk 52 visit.Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various timepoints.||mg/day P. Eq.||Inter-Quartile Range|Median
165317|NCT00207740|Secondary|Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24|The endpoint is the average number of severe asthma exacerbations per patient from Week (Wk) 24 through Wk 52 for the patients who did not discontinue study participation prior to Wk 24|Week 24 to Week 52|Analysis of this endpoint only includes patients (pts) who did not discontinue study participation prior to Wk 24. For the dropouts during the period between Wks 24- 52, worst case in similar pts was used as the number of severe exacerbations. Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various study timepoints||Events per patient from Wk 24 thru Wk 52||Standard Deviation|Mean
165318|NCT00207740|Secondary|Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients|The endpoint is change from baseline in rescue medication use at Wk 24 where the rescue medication use was based on the average over 7 days prior to visit.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.||Puffs/day||Inter-Quartile Range|Median
165319|NCT00207740|Primary|Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months|The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. For the dropouts, the worst case in similar patients was used as the number of severe exacerbations.||Events per patient through week (Wk) 24||Standard Deviation|Mean
165482|NCT00204932|Primary|Fat Mass|loss of fat mass, kg|6 months|||kg||Standard Deviation|Mean
165320|NCT00207740|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients|The endpoint is the change from baseline in the overall Asthma Quality of Life Questionnaire (AQLQ) score at 6 months. The AQLQ is a validated and self-administered questionnaire to evaluate symptoms and Quality of Life (QOL) in subjects with asthma and it has 32 questions in 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to score the importance of each of the positively identified problems on a 7-point scale (7 = not impaired at all - 1 = severely impaired).|Baseline to Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.||Points on scale||Inter-Quartile Range|Median
165321|NCT00207740|Primary|Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second|The endpoint is change from baseline in prebronchodilator clinic-measured percent predicted Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) with Last Observation Carried Forward (LOCF) at 6 months. The baseline visit starts at the end of 2 weeks run in phase.|Baseline and Week 24|The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using Last Observation Carried Forward (LOCF).||Percent predicted||95% Confidence Interval|Least Squares Mean
165322|NCT00207727|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|The EDSS is based on an independent neurologist’s examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10.|Baseline, Week 23|Intent to treat. Missing data was imputed. Missing EDSS scores was replaced with the last non-missing EDSS value observed (last observation carried forward).||Units on a scale||Inter-Quartile Range|Median
165323|NCT00207727|Secondary|Relapses of Multiple Sclerosis (MS) Through Week 23|Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS.|Week 23|Missing data remained missing. No treatment failure rule was implemented.||Relapses||Inter-Quartile Range|Median
165324|NCT00207727|Primary|The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.|A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.|Week 23|Intent to treat. Missing data was imputed. The average number of newly Gd enhancing T1-weighted lesions from all valid visits for the patient will be used when prohibited medications are initiated.||Lesions||Inter-Quartile Range|Median
165325|NCT00207714|Secondary|Summary of ACR-N, Index of Improvement at Week 16|The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient’s assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient’s global assessment of disease activity (VAS 0-10); c. Physician’s global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.|Week 16|Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied.||Scores on scale||Inter-Quartile Range|Median
165326|NCT00207714|Primary|Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 16|Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders.||Participants|||Number
165327|NCT00206440|Secondary|Safety of Esomeprazole When Used to Decrease the Incidence,Severity and Duration of Nausea/Vomiting/Retching in Breast Cancer Patients Who Are Receiving Anthracycline-based Chemotherapy.||10 years||||||
165328|NCT00206440|Primary|Number of Times a Subject Felt Sick to Her Stomach and Number of Times a Subject Required Rescue Medication|Proportion of patients who exhibit no more than one emetic episode and who do not require rescue medication for nausea from 2-7 days following chemotherapy.|2-7 days following chemotheraphy|||Proportion of patients who exhibit no mo|||Number
165329|NCT00206427|Primary|Clinical Response|Clinical efficacy was assessed by bidimensional tumor measurements of the primary cancer at baseline, and at the end of week 6. Clinical complete response (cCR) was defined as complete disappearance of the primary tumor. Clinical partial response (cPR) was defined as a decrease by at least 50% of the sum of the products of the largest perpendicular diameters. An increase of more than 25% was defined as clinical progressive disease (cPD). Any response that does not meet the definition of cCR, cPR, or cPD was defined as stable disease (cSD).|at the end of week 6.|All patients finished 6-week therapy were included. Two patients dropped off therapy early were excluded.||participants|||Number
165330|NCT00206427|Secondary|If GW572016 Inhibits HER1 and HER2 Signaling in Situ.||5 years||||||
165331|NCT00207142|Secondary|Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase|Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds.|Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase). Analysis used last observation carried forward (LOCF) to replace missing values.||percent change||95% Confidence Interval|Mean
165332|NCT00207142|Secondary|Summary of Adverse Events During Rescue Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.|Participants who received at least 1 dose of Rescue Phase study therapy||Participants|||Number
165333|NCT00207142|Secondary|Summary of Adverse Events During Maintenance Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.|Participants who received at least 1 dose of Maintenance Phase study therapy. As-treated population (as-treated refers to the actual treatment received during the Maintenance Phase).||Participants|||Number
165334|NCT00207142|Secondary|Summary of Adverse Events During Induction Phase|Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).|Participants who received at least 1 dose of Induction Phase study therapy.||Participants|||Number
165335|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase|Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 30-32|||Participants|||Number
165336|NCT00207142|Secondary|Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase|Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL. Time to suppression was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.|Week 16-18, Week 24-26, Week 38-40, Week 64-66|||Participants|||Number
165337|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound.|Baseline, Week 48 of Rescue Phase|||Participants|||Number
165338|NCT00207142|Secondary|Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase|Treatment outcome is based on the first reason of failure. These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound.|Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.|||Participants|||Number
165339|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase|Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement.|\Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 48 of Rescue Phase)||log10 c/mL||Standard Error|Mean
165340|NCT00207142|Secondary|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase|Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with HIV-1 RNA measurements at baseline and at Week 24 of Induction Phase).||log10 c/mL||Standard Error|Mean
165341|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase|Change From Baseline in CD4 Count at Week 48 of Rescue Phase. Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 48 of Rescue Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and Week 48 of Rescue Phase).||cells/mm3||Standard Error|Mean
165342|NCT00207142|Secondary|Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase|Change From Baseline in CD4 Count at Week 24 of Induction Phase. Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.|Baseline, Week 24 of Induction Phase|Analyses use observed values (participants included are those with CD4 measurements at Baseline and at the end of Induction Phase).||cells/mm3||Standard Error|Mean
165343|NCT00207142|Secondary|Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase|Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase. Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening.|End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization). Analysis uses observed values (participants included are those with CD4 measurements at end of Induction Phase and at Week 48 of Maintenance Phase).||cells/mm3||Standard Error|Mean
165483|NCT00204932|Secondary|Total Fat Oxidation|Blood chemistries and general well being|6 months||||||
165484|NCT00204373|Secondary|The Median Survival From the Time of Diagnosis.|The median survival from the time of diagnosis|survival or up to 240 months|||years||Standard Deviation|Median
165344|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)||Proportion of participants|||Number
165345|NCT00207142|Secondary|Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase|Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason. Time to treatment failure was analyzed using life tables. Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.|Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).||Proportion of participants|||Number
165346|NCT00207142|Secondary|Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population. (As-randomized refers to the treatment regimen assigned at randomization.)||Percentage of participants|||Number
165347|NCT00207142|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase|Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.|From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase|As-randomized population (as-randomized refers to the treatment regimen assigned at randomization).||Percentage of participants|||Number
165348|NCT00207090|Secondary|Number of Participants With Identified ECG Abnormalities|Triplicate 12-lead serial ECGs were performed pre-dose (just prior to infusion), 1.5, 3 (just prior to end of the infusion even if infusion lasted for less than or more than planned 3 hrs), 4, 6, 8 and 24 hrs after start of ixabepilone infusion. Triplicate 12-lead serial ECGs were also to be performed on the date prior to dosing at times approximating post-dose schedule (pre-dose triplicate set of ECGs also qualified as the 24-hr baseline ECGs). Normal ranges for ECG are as follows: heart rate: 40 - 125 bpm; PR: 0.1 - 0.2 msec; QRS: 0.06 - 0.12 msec; QTC: 0.3 - 0.45 msec; QT: 0.3 - 0.5 msec.|Data collected at screening, Day -1 and Day 1 (at 0, 1.5, 3, 4, 6, 8 and 24 hours) after start of infusion.|All participants treated with ixabepilone.||Participants|||Number
165349|NCT00207090|Secondary|QT Interval Corrected for Heart Rate (QTcF)|QT interval corrected for heart rate (QTcF) was assessed using triplicate 12-lead serial electrocardiograms (ECGs) that were performed at selected times after the first dose of ixabepilone without rifampin and at matched times prior to the first dose of ixabepilone. Abnormalities occurring at any time during the study were recorded.|Data collected at 0, 1.5, 3, 4, 6, 8 and 24 hours after start of infusion.|All participants treated with ixabepilone. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.||millisecond||90% Confidence Interval|Mean
165350|NCT00207090|Secondary|Number of Participants With Abnormal Physical Examination Findings|"Physical examination included height (screening only),weight,BSA,Eastern Cooperative Oncology Group Performance Status (ECOG PS),tendon reflexes,sensory function,motor strength. ECOG PS used to assess disease severity:score of 0 is fully active;1 is restricted physically strenuous activity;2 is ambulatory but unable to work;3 is capable of only limited self care;4 is completely disabled;5 is dead. Normal ranges:height:137-200cm or 54-79 inches;weight:40-135kg or 88-298 pounds (lbs);ECOG Scale:0-4. Abnormalities displayed here are those considered clinically significant by the investigator."|From screening to the off treatment visit.|All treated participants.||participants|||Number
165351|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day 22 (0-8 hours and 8-24 hours) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Ratio||Standard Deviation|Median
165352|NCT00207090|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|"Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. Normal ranges for the above are as follows: heart rate: 40 - 125 beats per minute (bpm); systolic BP: 65 - 200 millimeters of mercury (mmHg); diastolic BP: 40 - 120 mmHg; respiratory rate: 10 - 25 breaths per minute; temperature: 95 - 105F or 35 - 40.5C. The abnormalities displayed here are those considered clinically significant by the investigator and include abnormalities recorded at any time during study."|From screening to the off treatment visit.|All treated participants.||participants|||Number
165353|NCT00207090|Primary|Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1|The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.|Day -1 (0-8 hours and 8-24 hours), 24 hours before starting of ixabepilone administration.|All treated participants who were evaluable for PK analysis.||Ratio||Standard Deviation|Mean
165354|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T])|AUC (0-T) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||nanogram (ng)*hr/mL||Standard Deviation|Mean
165355|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid.|Abnormalities occurring at any time during the study were graded per NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows:Calcium: Grade 3: 6-<7 or >12.5-13.5mg/dL, Grade 4:<6 or >13.5mg/dL. Magnesium: Grade 3:0.6-<0.8 or >2.46-6.6mEq/L, Grade 4:<0.6 or >6.6mEq/L. Potassium: Grade 3:2.5-<3 or >6-7mmol/L, Grade 4:<2.5 or >7.0 mmol/L. Sodium: Grade 3:120-<130 or >155-160 mEq/L, Grade 4:<120 or >160mEq/L. Glucose: Grade 3:30-<40 or >250-500mg/dL, Grade 4:<30 or >500mg/dL. Uric acid: Grade 3:>ULN-10mg/dL with physiologic consequences, Grade 4:>10mg/dL.|Screening, Days 2 and 22.|All treated participants.||Participants|||Number
165356|NCT00207090|Primary|Time to Reach Maximum Observed Concentration (T Max)|T max was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Hrs||Full Range|Median
165357|NCT00207090|Primary|Volume of Distribution at Steady-state (Vss)|Vss was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||L||Standard Deviation|Mean
165358|NCT00207090|Primary|Total Body Clearance (CLT)|CLT was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Litres(L)/hr||Standard Deviation|Mean
165359|NCT00207090|Primary|Mean Residence Time Adjusted for Infusion Time (MRT [INF])|(MRT [INF]) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Hrs||Standard Deviation|Mean
165360|NCT00207090|Primary|Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half)|T half was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||Hrs||Standard Deviation|Mean
165361|NCT00207090|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous|Abnormalities occurring at any time during the study were graded per the NCI CTC (1=mild, 2=moderate, 3=severe, 4=life threatening). Grade 3 and 4 criteria were as follows: Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase: Grade 3: >5-20 x upper limit of normal (ULN), Grade 4: >20 x ULN. Bilirubin: Grade 3: >3-10 x ULN, Grade 4: >10 x ULN. Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC). Creatinine: Grade 3: >3-6 x ULN, Grade 4: >6 x ULN. Phosphorous: Grade 3: 1-<2mg/dL, Grade 4: <1mg/dL.|Screening, Days 1 and 22.|All treated participants.||participants|||Number
165362|NCT00207090|Secondary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities occurring at any time during the study were graded per NCI CTC, v3.0 criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are given below. Neutrophils: Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Leukocytes: Grade 3: 1.0 - <2.0x10^9/L, Grade 4: <1.0x10^9/L. Neutrophils + bands (absolute): Grade 3: 0.5 - <1.0x10^9/L, Grade 4: <0.5x10^9/L. Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Lymphocytes: Grade 3: 0.2 - <0.5x10^9/L, Grade 4: <0.2x10^9/L. Platelets: Grade 3: 25.0 - <50.0x10^9/L, Grade 4: <25.0x10.|Screening, Day 1, Day 8, Day 15, Day 22 and Day 29-36.|All treated participants.||participants|||Number
165363|NCT00207090|Secondary|Number of Participants Who Died and Who Experienced Other Serious AEs (SAEs), Grade 3-4 AEs, Drug-related AEs and AEs Leading to Study Drug Discontinuation|AEs:new untoward medical occurrences/worsening of pre-existing medical condition,whether or not related to study drug.SAE:AE resulting in death;life threatening;resulted in persistent/significant disability/incapacity;resulted in/prolonged existing hospitalization;a congenital anomaly/birth defect;overdose.Drug-related AEs: relationship to drug of certain;probable;possible;or missing.Participants who discontinued study due to AE were also recorded.AEs graded using National Cancer Institute (NCI) Common Toxicity Criteria (CTC),v3:Grade 1=mild,2=moderate, 3=severe,4=life threatening,5=death.|From Day 1 to 30 days after the last dose of study drug.|All treated participants.||participants|||Number
165364|NCT00207090|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF])|AUC (INF) was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|All treated participants who were evaluable for PK analysis.||nanogram (ng)*hour(hr)/mL||90% Confidence Interval|Geometric Mean
165365|NCT00207090|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.|Of the 15 patients in each group, only those with evaluable pharmacokinetic (PK) results are presented.||nanogram (ng)/millilter(mL)||90% Confidence Interval|Geometric Mean
165366|NCT00206726|Secondary|Number of Participants With Minimal Residual Disease (MRD)|Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.|When CR is confirmed|All participants for whom CR was confirmed||participants|||Number
165469|NCT00205712|Secondary|Visual Analog Scale (VAS) Pain Intensity|Pain intensity was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.||Scale of 1-10||Standard Deviation|Mean
165367|NCT00206726|Secondary|Percentage of Participants With Overall Response at Different Observation Times|Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier|Subjects who achieved Overall Response (OR) defined as number of subjects who achieved CR + number of subjects who achieved PR||percentage of participants in response|||Number
165368|NCT00206726|Secondary|Progression-free Survival (PFS)|Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|ITT population (all subjects enrolled and registered). As three subjects never received study medication, they were to be censored at day 1 for all time-to-event analyses. Thus, the Kaplan-Meier estimates beyond day one are the same for both, the ITT and the safety population.||percentage alive without progression|||Number
165369|NCT00206726|Secondary|Overall Survival (OS)|Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year|1 year after start of treatment|Safety Population (all subjects treated)||Percentage of participants alive|||Number
165370|NCT00206726|Secondary|Overall Response (OR)|Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.|28 days after last cycle with confirmation 2 months later|ITT Population (all subjects enrolled and registered).||Percentage of participants with CR or PR|||Number
165371|NCT00206726|Primary|Complete Response (CR)|Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes <30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.|28 days after last cycle with confirmation 2 months later|ITT population (all enrolled and registered subjects).||Percentage of participants with CR|||Number
165372|NCT00206102|Secondary|Number of Participants With Potential Extrapyramidal Symptoms (EPS)|Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor|From start of the study treatment to last dose plus 30 days|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||Participants|||Number
165373|NCT00206102|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||units on scale||Standard Deviation|Mean
165374|NCT00206102|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||units of scale||Standard Deviation|Mean
165375|NCT00206102|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Month 24|The Safety analysis set included all randomized participants who received at least 1 dose of study medication||units on scale||Standard Deviation|Mean
165376|NCT00206102|Secondary|Number of Relapses of Schizophrenia or Schizoaffective Disorder|Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects.|At Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||Relapses|||Number
165377|NCT00206102|Secondary|Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score|PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
165470|NCT00205712|Primary|Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score|Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)|Before Ketamine, During Ketamine|Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.||Scale of 0-6||Standard Deviation|Mean
165378|NCT00206102|Secondary|Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score|Q-LES-Q total score is the sum of the 16 times of Q-LES-Q SF(range:16-80).Each item has a 5 point satisfaction level scale:from 1=very poor(worst value) to 5=very good(best).Larger values indicate a higher perceived quality of life enjoyment and satisfaction.Change in Q-LES-Q total score:total score at month 24 minus total score at randomization|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
165379|NCT00206102|Secondary|Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score|CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization.|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score (not related to CGI-S), and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
165380|NCT00206102|Secondary|Change in the PANSS Psychopathology Subscale Score|"PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= absent psychosis symptom, 7= extreme symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
165381|NCT00206102|Secondary|Change in the PANSS Negative Subscale Score|"PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
165382|NCT00206102|Secondary|Change in the PANSS Positive Subscale Score|"PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
165383|NCT00206102|Secondary|Change in the Positive and Negative Syndrome Scale (PANSS) Total Score|"PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score."|Randomization to Month 24|The intention-to-treat for psychiatric assessments (ITTP) analysis included all randomized participants who had a valid baseline and at least 1 post baseline assessment of PANSS total score, and received at least 1 dose of study medication.||units on scale||Standard Deviation|Mean
165384|NCT00206102|Primary|Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.||Participants with P type event|||Number
165385|NCT00206102|Primary|Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale|Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.||Participants with N type event|||Number
165386|NCT00206102|Primary|Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale|Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst.|Randomization to Month 24|The 2-year eye per protocol (E2PP) analysis included all randomized participants who met eye eligibility, had a valid baseline LOCS II evaluation, had reached the study endpoint of either a LOCS II identified cataractogenic potential event or dosed for 21 months without a LOCS II event, and had no major protocol deviations.||Participants with C type event|||Number
165387|NCT00206076|Secondary|Number of Participants With Adverse Events Including Infections at 12 Months||12 months|everyone enrolled who completed the study||participants|||Number
165388|NCT00206076|Secondary|Patient and Graft Survival at 12 Months||12 months|everyone enrolled who completed the study||participants|||Number
165389|NCT00206076|Primary|Number of Biopsy Proven Rejections at 12 Months|assessed by liver biopsy using Banff International Consensus Schema|12 months|||participants|||Number
165392|NCT00205855|Primary|Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.|"The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal tono pain and 10 is equal to worst pain imaginable. This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS."|2 weeks post initial fitting|||participants with > 50% VAS improvement|||Number
165393|NCT00205803|Secondary|Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the Toddler Dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinant antibody titer for the specified serotype.||titer||95% Confidence Interval|Geometric Mean
165394|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were assessed. Results are reported for the serotypes with a determinate antibody titer.|One month after the toddler dose (13 to 16 months of age)|All-available (per protocol) population consisting of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)= number of participants with determinant posttoddler dose antibody titer to the given serotype.||Percentage of participants||95% Confidence Interval|Number
165395|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody titer to the given serotype.||Percentage of participants||95% Confidence Interval|Number
165396|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||EU/mL||95% Confidence Interval|Geometric Mean
165397|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a postinfant series blood sample.||titer||95% Confidence Interval|Geometric Mean
165398|NCT00205803|Secondary|Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||IU/mL||95% Confidence Interval|Geometric Mean
165399|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.|one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)=number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||milli International Units (mIU)/mL||95% Confidence Interval|Geometric Mean
165400|NCT00205803|Secondary|Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series||one month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of participants with a determinate antibody concentration for the specified concomitant vaccine component.||μg/mL||95% Confidence Interval|Geometric Mean
165401|NCT00205803|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series|Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.|One month after the infant series (7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate postinfant series antibody level to the given concomitant vaccine component.||Percentage of participants||95% Confidence Interval|Number
165485|NCT00204373|Primary|Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.|number of participants with control of gastric acid production|up to 240 months from study enrollment|||participants|||Number
165402|NCT00205803|Secondary|Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 7 common pneumococcal serotypes (Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.|Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)|All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to proposed analysis;(n)= number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
165403|NCT00205803|Secondary|Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.|One month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n)=number of participants with a determinate antibody concentration for the specified serotype.||μg/mL||95% Confidence Interval|Geometric Mean
165404|NCT00205803|Secondary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose|Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|One month after the toddler dose (at 13 to 16 months of age)|The All-Available Toddler Immunogenicity population consisted of eligible participants who had at least 1 valid and determinate assay result related to the proposed analysis; (n)=number of participants with a determinate posttoddler dose IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
165405|NCT00205803|Primary|Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series|Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|one month after 3-dose infant series (at 7 months of age)|Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.||percentage of participants||95% Confidence Interval|Number
165406|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events|Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values.||percentage of participants|||Number
165407|NCT00205803|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions|Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category.|Within 15 days after each dose|The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.||percentage of participants|||Number
165408|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
165409|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points."|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
165515|NCT00203476|Secondary|Incidents of Rhabdomyolysis||12 weeks|||participants|||Number
165410|NCT00205777|Secondary|Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||mm||Standard Error|Least Squares Mean
165411|NCT00205777|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||millimeter (mm)||Standard Deviation|Mean
165412|NCT00205777|Secondary|Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Error|Least Squares Mean
165413|NCT00205777|Secondary|European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)|QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
165414|NCT00205777|Secondary|Change From Baseline in Women’s Health Questionnaire (WHQ) at Month 12, 24 and 36|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline, Months 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Error|Least Squares Mean
165415|NCT00205777|Secondary|Women’s Health Questionnaire (WHQ)|WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.|Baseline|ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’=participants who were evaluable for this measure at the specified time point for each arm group.||Units on a scale||Standard Deviation|Mean
165471|NCT00205504|Secondary|Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|These inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).|Baseline and 6 months|||ng/mL||Standard Deviation|Mean
165472|NCT00205504|Secondary|Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months|||cm||Standard Deviation|Mean
165416|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
165417|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRBV|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimetre/square millimetre/year||Standard Error|Least Squares Mean
165418|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||ratio/mm||Standard Error|Least Squares Mean
165419|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TbN|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||ratio/millimeter (ratio/mm)||Standard Error|Least Squares Mean
165420|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mcm/d||Standard Error|Least Squares Mean
165421|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: MAR|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mcm/days (mcm/d)||Standard Error|Least Squares Mean
165422|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||days||Standard Error|Least Squares Mean
165423|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Mlt|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||days||Standard Error|Least Squares Mean
165473|NCT00205504|Secondary|Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Body Mass Index is a calculation of height and weight: kg/m²|Baseline and 6 months|||kg/m²||Standard Deviation|Mean
165474|NCT00205504|Secondary|Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months|||mm Hg||Standard Deviation|Mean
165516|NCT00203476|Secondary|LFT Elevation||12 weeks|||participants|||Number
165424|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||Activation of bone formation/year||Standard Error|Least Squares Mean
165425|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: ACF|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||Activation of bone formation/year||Standard Error|Least Squares Mean
165426|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
165427|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFRTS|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||cubic millimetre/square millimetre/year||Standard Error|Least Squares Mean
165428|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
165429|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: SuD|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||square millimeter per cubic millimeter||Standard Error|Least Squares Mean
165430|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||yrs||Standard Error|Least Squares Mean
165431|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BFP, RP and RmP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||years (yrs)||Standard Error|Least Squares Mean
165475|NCT00205504|Secondary|Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).|Baseline and 6 months|||pg/mL||Standard Deviation|Mean
165432|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mm^2||Standard Error|Least Squares Mean
165433|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: TtAr|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||Square millimeter (mm^2)||Standard Error|Least Squares Mean
165434|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: TSG|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||mm||Standard Error|Least Squares Mean
165435|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) [TSG]. All specimens were demineralized and subjected to staining procedures (Goldner`s staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm^2 and expressed as percent (%) of the total surface.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.||millimeter (mm)||Standard Error|Least Squares Mean
165436|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||mcm||Standard Error|Least Squares Mean
165437|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||micrometer (mcm)||Standard Error|Least Squares Mean
165438|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 60|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||Percentage of indices||Standard Error|Least Squares Mean
165476|NCT00205504|Secondary|Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Waist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.|Baseline and 6 months|||ratio||Standard Deviation|Mean
165477|NCT00205504|Secondary|Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women||Baseline and 6 months|||pg/mL||Standard Deviation|Mean
165517|NCT00203476|Primary|LDL Goal Attainment|Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.|12 weeks|intention to treat||participants|||Number
165439|NCT00205777|Secondary|Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP|Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).|Month 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.||Percentage of indices||Standard Error|Least Squares Mean
165440|NCT00205777|Secondary|Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36|Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).|Baseline, Months 6, 12, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
165441|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Percent change||Inter-Quartile Range|Median
165442|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
165443|NCT00205777|Secondary|Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12|C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
165444|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 72 and 84|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 72, 84|mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Percent change||Inter-Quartile Range|Median
165445|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Months 36 and 60|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 36, 60|mITT of SP1 population included all randomized participants who took at least 1 dose of test article.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
165446|NCT00205777|Secondary|Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12|Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.|Baseline, Months 3, 6, 12|ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.||Percent change||Inter-Quartile Range|Median
165447|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 72, 84|Modified ITT(mITT) population of SP1 population:randomized participants who took at least 1 dose of test article;had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.||Percent change||Standard Deviation|Mean
165448|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Month 48, 60|mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percent change||Standard Error|Least Squares Mean
165478|NCT00205504|Secondary|Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women|Inflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.|Baseline and 6 months|||ng/mL||Standard Deviation|Mean
165518|NCT00203424|Secondary|Overall Survival||Survival status was assessed every 3 months after completion of study treatment for a maximum of 3 years after administration of first study treatment|||participants|||Number
165449|NCT00205777|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36|BMD of lumbar spine (Lu Sp) and hip (total hip [Tl Hp], femoral neck [Fe Ne] and femur trochanter [Fe Tr]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.|Baseline, Months 6, 12, 18, 24, 36|ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percent change||Standard Error|Least Squares Mean
165450|NCT00205777|Secondary|Change From Baseline in Height at Month 84|Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||mm||Standard Deviation|Mean
165451|NCT00205777|Secondary|Change From Baseline in Height at Month 60|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.||mm||Standard Error|Least Squares Mean
165452|NCT00205777|Secondary|Change From Baseline in Height at Month 36|Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).|Baseline, Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.||millimeter (mm)||Standard Error|Least Squares Mean
165453|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 84|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 84|mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.||Percentage of participants||95% Confidence Interval|Number
165454|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 60|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.||Percentage of participants||95% Confidence Interval|Number
165455|NCT00205777|Secondary|Percentage of Participants With Non-vertebral Fractures Through Month 36|Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.||Percentage of participants||95% Confidence Interval|Number
165456|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 84|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
165457|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 60|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
165458|NCT00205777|Secondary|Number of Participants With Worsening Vertebral Fractures Through Month 36|A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
165459|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 84|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 84|mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
165460|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 60|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
165461|NCT00205777|Secondary|Percentage of Participants With New Clinical Vertebral Fractures Through Month 36|A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.|Baseline through Month 36|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||Percentage of participants||95% Confidence Interval|Number
165462|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 84|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 84|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Breast cancer per 1000-women years|||Number
165463|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 60|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 60|SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Breast cancer per 1000-women years|||Number
165464|NCT00205777|Secondary|Incidence of Breast Cancer Through Month 36|Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).|Baseline through Month 36|Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.||Breast cancer per 1000-women years|||Number
165465|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 84|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 84|Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.||Percentage of participants||95% Confidence Interval|Number
165466|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 60|New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 60|ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percentage of participants||95% Confidence Interval|Number
165467|NCT00205777|Primary|Percentage of Participants With New Vertebral Fractures Through Month 36|New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.|Baseline through Month 36|Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.||Percentage of participants||95% Confidence Interval|Number
165468|NCT00205712|Secondary|Visual Analog Scale (VAS) Anxiety Rating|Anxiety was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.|Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up|||Scale of 1-10||Standard Deviation|Mean
165486|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|3 nights|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.||mU/(liter x min)||Standard Error|Mean
165487|NCT00203996|Primary|Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|Baseline|Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.||mU/(liter x min)||Standard Error|Mean
165488|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||nanogram/milliliter||Standard Error|Mean
165489|NCT00203996|Secondary|Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.|15 minutes over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||nanogram/milliliter||Standard Error|Mean
165490|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||microgram/deciliter||Standard Error|Mean
165491|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
165492|NCT00203996|Primary|Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline]|Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
165493|NCT00203996|Secondary|Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline]|This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.|10 minutes, over a period of 24 hours|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||microgram/deciliter||Standard Error|Mean
165494|NCT00203996|Secondary|Aim 1: Visceral Adiposity [After Treatment]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.|||||
165495|NCT00203996|Secondary|Aim 1: Visceral Adiposity [Baseline]|Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.|up to half of an hour|No participants were randomized to this arm.|||||
165496|NCT00203996|Secondary|Aim 1: Blood Pressure [After Treatment]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|8 weeks|No participants were randomized to these study arms.|||||
165497|NCT00203996|Secondary|Aim 1: Blood Pressure [Baseline]|Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.|baseline (0 weeks)|No participants were randomized to these study arms.|||||
165498|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|8 weeks|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
165499|NCT00203996|Primary|Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]|Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.|baseline (0 weeks)|The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.||mU/(liter x min)||Standard Error|Mean
165500|NCT00203996|Primary|Aim 1: Apnea-hypopnea Index (AHI) [After Treatment]|Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|8 weeks|No participants were randomized to these study arms.|||||
165501|NCT00203996|Primary|Aim 1: Apnea–Hypopnea Index (AHI) [Baseline]|Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.|baseline|No participants were randomized to these study arms.|||||
165502|NCT00203931|Secondary|Progression-free Survival Based on Serum Biomarker Status|Progression-free survival in this analysis looking at the association between a serum proteomic biomarker and progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 10 patients did not have a pre-treatment/baseline serum marker classification and thus were excluded from this analysis.||months||95% Confidence Interval|Median
165503|NCT00203931|Secondary|Overall Survival|Overall survival will be defined as the time from the start of treatment until death from any cause.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)||months||95% Confidence Interval|Median
165504|NCT00203931|Secondary|Objective Response Rate|Objective response (complete response [CR] + partial response [PR]) will be evaluated using RECIST criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter of target lesions.|up to 2 years|Includes evaluable patients (those that received at least 3 doses of cetuximab).||percentage of participants||95% Confidence Interval|Number
165505|NCT00203931|Secondary|Progression-free Survival Based on Rash Development|Progression-free survival in this landmark analysis looking at the utility of early rash in predicting progression-free survival will be defined as the time from day 22 of study therapy until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first. Patients last known to be alive and progression-free were censored at the date of the last scan without evidence of progression.|up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 2 patients died or progressed prior to day 22 of cetuximab therapy and thus were excluded from this analysis.||months||Standard Error|Median
165506|NCT00203931|Primary|Progression-free Survival|Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.|Up to 5 years|Includes evaluable patients (those that received at least 3 doses of cetuximab)||months||95% Confidence Interval|Median
165507|NCT00203892|Secondary|Evidence of Dose Limiting Toxicities of Immunization With Modified CEA (Carcinoembryonic Antigen) Peptide.|Dose-limited toxicity included Grade 2 or higher hemorrhage or allergic reaction or clinical evidence of autoimmune disease. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v2.0.|participants were followed while they were on study treatment, a median of 8 weeks|||participants|||Number
165508|NCT00203892|Primary|Maximum T Cell Response From Baseline|"T cell frequency (spots per 10^4 CD8+ cells) was measured by ELISPOT (Enzyme-linked immunosorbent spot) assay. Blood was collected for this assay at baseline and every 4 weeks for the first 8 cycles. After the eighth cycle, a blood sample was collected at the time of disease progression. The maximum T cell response was calculated as: peak value on treatment - baseline value.~A positive value indicates an increase from baseline."|baseline and every 4 weeks on treatment|The analysis population for the primary outcome included the 14 patients who received at least 3 doses of the CEA vaccine and had a ELISPOT at least at baseline and after the 3rd cycle.||spots per 10^4 CD8+ cells||Full Range|Median
165509|NCT00203502|Secondary|Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer|pCR rate for triple negative patients--percent|at surgery, one day|Patients with triple negative breast cancer||% pCR among triple negative pts||90% Confidence Interval|Number
165510|NCT00203502|Secondary|To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline|Absolute change in LVEF, where LVEF values are measured in percentage units|Immediately before treatment and 1 year after start of treatment|||Percentage of LVEF||Standard Deviation|Mean
165511|NCT00203502|Secondary|Percentage of Participants With Grade 3 or 4 Adverse Events|Percent of participants who had at least one grade 3 or 4 adverse event|After each chemotherapy infusion, approximately one hour|||percentage of pts w/ grade 3/4 AE||90% Confidence Interval|Number
165512|NCT00203502|Secondary|Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.|Clinical complete response was defined using RECIST response categories as the clinical response to chemotherapy|At completion of chemotherapy treatment, an average of one hour|All participants evaluated surgically||percentage of pts w/ cCR||90% Confidence Interval|Number
165513|NCT00203502|Primary|Percentage of Participants With Pathological Complete Response.|Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.|Participants were assessed during surgery, an average of one hour|||percentage of evaluable patients||90% Confidence Interval|Number
165514|NCT00203476|Secondary|Change in HDL From Baseline to 12 Weeks.||baseline and 12 weeks|Change in HDL||mg/dl||Standard Deviation|Mean
165520|NCT00203424|Secondary|Time to Tumor Progression.|Measured once for participants who experienced tumor recurrence per protocol. Imaging done to measure tumor progression only after documented tumor recurrence|Tumor progression assessed every 3 months during Follow-up Period for a maximum of 3 years after administration of first study treatment|||days|||Number
165521|NCT00203424|Primary|To Evaluate the Efficacy of Bevacizumab Plus Erlotinib||Determined by time to tumor recurrence, as measured by rising prostate specific antigen (PSA) after radical prostatectomy.|Of the 23 subjects registered for treatment, 19 were analysed for efficacy, 4 subjects were excluded from analysis because of withdrawal of subjects prior to first tumor assessment.||participants|||Number
165522|NCT00203411|Secondary|Quality of Life of Patients|"Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Trial Outcome Index (TOI) – a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. Questions address Physical, Emotional and Functional Well-Being. Scale: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), and very much (4). Higher numbers indicate a better state of well being. Scale 0 -136. Higher numbers indicating a better state of well-being.~The Overall scores for the FACT-C Composite scale range between 0-100 with higher scores indicating a better state of well being.~The EQ VAS= Euro Quality of Life 5 Dimension Self Reported Healthstate. It records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labeled 0 ‘Best imaginable health state’ and 100 ‘Worst imaginable health state’."|Baseline, Cycle 2, and End of Study|||score on a scale||Standard Deviation|Mean
165523|NCT00203411|Secondary|Response Rates|Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|every 21 days up to 12 months|||participants|||Number
165524|NCT00203411|Primary|Number of Subjects Requiring Dose Modifications|Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.|3 months|all subjects that received chemotherapy||participants|||Number
165525|NCT00203411|Primary|Time to Disease Progression|Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date|12 months|||months||95% Confidence Interval|Median
165526|NCT00203307|Secondary|Reduction in Days Using an Acute Headache Treatment During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.||84 day period on olanzapine compared to 84 day period on placebo||||||
165527|NCT00203307|Secondary|Reduction of Migraine Attack Frequency During Each 28-day Interval of the Active Treatment Period as Compared to Each 28-day Interval of the Placebo Treatment Period, Per Subject. Individual Migraine Attacks Are Separated by 48-hours Pain Free Time. A||each 28 day interval of active treatment c ompared to placebo||||||
165528|NCT00203307|Primary|Difference in Migraine Headache Periods During the Active Treatment Period as Compared to the Placebo Treatment Period, Per Subject.|"Definition of migraine headache period: One migraine period is defined as a 24-hour period starting at the time of onset of the migraine headache, during which the migraine headache is present*.~Definition of time frames: First treatment period: Day 1 to 84. Second treatment period: day 113-196. Washout phase is day 85-112."|84 day period on placebo compared to 84 day period on olanzapine|||headache periods||Standard Deviation|Mean
165529|NCT00203294|Secondary|To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes||||||
165530|NCT00203294|Secondary|To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.||20 minutes||||||
165531|NCT00203294|Primary|Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups.||20 minutes||||||
165532|NCT00203294|Primary|Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain|Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment|20 minutes|There were 15 patients in group A (no steroids injected) and 14 in group B (steroids injected).||units on a scale||Standard Deviation|Mean
165533|NCT00203268|Primary|Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.|Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.|2 hours post treatment and 4 hours post treatment|||participants|||Number
165534|NCT00203242|Secondary|Use of Acute and Rescue Medications During Loading (2 Days) and Maintenance Phases as Compared to Subject-reported Baseline. This Will be Calculated Using the Total Number of Doses of Acute Medications Per 24-hour Period Calendar Days.||Baseline compared to maintenance (up to 47 days)||||||
165535|NCT00203242|Secondary|Change in Frequency of Attacks Per 24 Hour Period, Duration of Individual Attacks (in Minutes), or Severity of Attacks Compared to the Subject-reported Baseline Values.||Compare Baseline through 47 days||||||
165536|NCT00203242|Primary|Time Required to Achieve a Greater Than or Equal to 50% Reduction in Frequency or Severity of Individual Cluster Attacks Compared to Subject-reported Baseline.|Severity: measured on an 11 point scale, where 0 = no pain and 10= excruciating pain. Outcome is time to 50% reduction in severity (or frequency) compared to baseline (prior to treatment).Frequency: Number of attacks per day.The Time to significant response was measured 2 ways: significant initial response and significant maintained response. For initial response, the time to significant response was: Mean of 2.1(1.5) days for severity and 1.9 (1.6) days for frequency. The time to significant response maintained was 29.7 (13.8) for severity and 29.0 (14.3) for frequency.|baseline (day 0) through 47 days after first infusion|||days||Standard Deviation|Mean
165537|NCT00203229|Primary|Average Number of Pain Attacks|The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose.|Day 150 Visit #7|||Pain attacks||Standard Deviation|Mean
165538|NCT00203216|Secondary|Change in Use of Acute Agents Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.||Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.||||||
165539|NCT00203216|Secondary|Change in Average Severity if Migraine Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period||Baseline period compared to 28 day interval prior to Visit 4-7.||||||
165540|NCT00203216|Secondary|Change in Number of Migraine Days Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:~visit_4 = first follow-up interval (0 to 28 days after starting study drug)~visit_5 = second follow-up interval (28 to 56 days)~visit_6 = third follow-up interval (56 to 84 days)~visit_7 = fourth follow-up interval (84 to 126 days)"|Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.||||||
165541|NCT00203216|Primary|The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.|"Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals:~visit_4 = first follow-up interval (0 to 28 days after starting study drug)~visit_5 = second follow-up interval (28 to 56 days)~visit_6 = third follow-up interval (56 to 84 days)~visit_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI"|Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).|||migraine attacks per month||Standard Deviation|Mean
165542|NCT00203203|Secondary|Linear Local Shortening (LLS)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.|baseline and 6 months|||percentage of linear local shortening||Standard Deviation|Mean
165543|NCT00203203|Secondary|Endocardial Unipolar Voltages (UPV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV.|baseline and 6 months|The data was analyzed for all participants in control and treated groups.||Unipolar voltage (mV)||Standard Deviation|Mean
165544|NCT00203203|Secondary|Left Ventricular End-Systolic Volume (LVESV) (ml)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||ml||Standard Deviation|Mean
165545|NCT00203203|Secondary|Left Ventricular End-Diastolic Volume (LVEDV)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.|baseline, 3 months and 6 months|||Volume in left ventricle (milliliters)||Standard Deviation|Mean
165546|NCT00203203|Secondary|Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%)|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the gold standard."|baseline and 6 months|The data was analyzed for all participants in control and treated groups.||Angiography LVEF (%)||Standard Deviation|Mean
165547|NCT00203203|Secondary|Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||Left Ventricular Ejection Fraction (%)||Standard Deviation|Mean
165548|NCT00203203|Secondary|Echocardiography Wall Motion Score Index (WMSI)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.||Wall Motion Score Index||Standard Deviation|Mean
165711|NCT00198081|Primary|Concentration of PGE2 in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
165549|NCT00203203|Secondary|Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.|baseline and 3 months|The data was analyzed for all participants in control and treated groups.||VE/VCO2 slope||Standard Deviation|Mean
165550|NCT00203203|Secondary|Echocardiography (EF)Percent (%)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||Ejection Fraction %||Standard Deviation|Mean
165551|NCT00203203|Secondary|Myocardial Oxygen Consumption (MVO2)|Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||Percentage of Oxygen Saturation||Standard Deviation|Mean
165552|NCT00203203|Secondary|New York Heart Association (NYHA)Classification|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.~Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||NYHA Functional Class||Standard Deviation|Mean
165553|NCT00203203|Secondary|Canadian Cardiovascular (CCS) Angina Score|"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).~Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"|baseline, 3 months and 6 months|The data was analyzed for all participants in control and treated groups.||units on a scale||Standard Deviation|Mean
165554|NCT00203203|Primary|Safety of Autologous-bone-marrow Injections|Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).|up to 2 weeks post-procedure, 3 months and 6 months|Adverse events which occurred in all participants.||participants|||Number
165555|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions|"Results represent the database as of January 29, 2009.~The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage."|Day 0, Month 36 or early termination visit|Treated population of participants with an MRI at the stated time frames.||cm^3||Standard Deviation|Mean
165556|NCT00203047|Secondary|Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions|"Results represent the database as of January 29, 2009.~The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden."|Day 0, Month 36 or the early termination visit|Treated population of participants with an MRI at the stated time frames.||cm^3||Standard Deviation|Mean
165557|NCT00203047|Secondary|Cumulative Number of Enhancing Lesions at Months 12, 24 and 36|"Results represent the database as of January 29, 2009.~Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered."|Months 12, 24, and 36|Treated population who had at least a 12 month MRI||lesions||Standard Deviation|Mean
165558|NCT00203047|Primary|Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method|"Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change.~Adjusted (least square) mean values are presented."|Day 0, latest scan at month 24, 36 or early termination visit|Treated population of participants who had both a baseline MRI and an MRI at least one of the three during study time frames. The latest MRI was used if more than one during study MRI was available.||percent change of baseline brain volume||Standard Error|Least Squares Mean
165559|NCT00202878|Secondary|Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, non-fatal MI, documented UA that requires admission into a hospital, all revascularization (including non-coronary) occurring at least 30 days after randomization, and non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, non-fatal MI, unstable angina with hospitalization, all revascularization occurring ≥ 30 days after randomization, and non-fatal stroke within 7 Years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
165560|NCT00202878|Secondary|Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
165561|NCT00202878|Secondary|Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
165562|NCT00202878|Primary|Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)|The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction [MI], documented unstable angina [UA] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization.|Up to approximately 9 years|All participants who were randomly assigned to a treatment arm.||Percentage of Participants||95% Confidence Interval|Number
165563|NCT00202839|Secondary|The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.|Virologic response was defined as undetectable HCV-RNA level in the blood.|48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)|Intention to treat [ITT] population||Percentage of Participants|||Number
165564|NCT00202839|Primary|The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy|24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy|Intention to treat [ITT] population defined as participants who received at least one dose of study medication.||Percentage of participants|||Number
165565|NCT00202722|Secondary|Patient Satisfaction|Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied.|From start of remifentanil treatment until delivery|||Participants|||Number
165566|NCT00202722|Primary|Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)|Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints.|From start with remifentanil treatment until delivery, up to 8 hours.|Per protocol||millimeters||Standard Deviation|Mean
165567|NCT00202449|Secondary|Study Days Completed as an Indicator of Medication Tolerability at Weeks 6 & 12||6 and 12 weeks||||||
165568|NCT00202449|Secondary|Change in Quality of Life Will be Assessed by the Quality of Life Inventory at Weeks 6 & 12||6 and 12 weeks||||||
165569|NCT00202449|Secondary|Change in Depressive Symptoms Will be Assessed by the Hamilton Depression Rating Scale at Weeks 6 & 12||6 and 12 weeks||||||
165570|NCT00202449|Secondary|Additional Data on Change in Nightmares Will be Assessed by the PTSD Dream Rating Scale and Nightmare Frequency Questionnaire at Weeks 6 & 12||6 and 12 weeks||||||
165571|NCT00202449|Primary|Change in Global Trauma-related Symptom Severity and Functioning Will be Assessed by the Clinical Global Impression of Change at Week 12|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from baseline to Week 12.|12 weeks|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).||scale points||Standard Deviation|Mean
165572|NCT00202449|Primary|Change in Sleep Will be Assessed by the Pittsburgh Sleep Quality Index at Week 12|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 12.|12 weeks|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at Week 12 (e.g., completed the study).||scale points||Standard Deviation|Mean
165573|NCT00202449|Primary|Change in Combat Trauma-related Nightmares Will be Assessed by the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 12."|Baseline and Week 12|Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).||scale points||Standard Deviation|Mean
165574|NCT00201877|Secondary|Correlative Studies||During induction (weeks 1-15); PK every 2 months during maintenance.||||||
165575|NCT00201877|Secondary|Progression-free Survival(PFS)||2 years|||percentage of patients||95% Confidence Interval|Number
165576|NCT00201877|Primary|Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma.|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.|Day 1 of each cycle|grade 3 neurotoxicity which consisted of constipation/ileus, sensory or motor neuropathy, or orthostatic hypotension||patients|||Number
165577|NCT00201877|Primary|Overall Response Rate||Every 3 months|||percentage of patients|||Number
165578|NCT00201864|Secondary|Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels||Prestudy, Day 7 and Day 120|Increase in mean levels from baseline to day 120. Not all patients had the IGF-1 and IGFBP-3 levels present.||ng/mL||Standard Deviation|Mean
165579|NCT00201864|Secondary|Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant|5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points.|Day 7 and Day 120|Only 9 patients had evaluable PK data collected and analyzed||ng/ml||Standard Deviation|Mean
165580|NCT00201864|Secondary|Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)|"Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria.~Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR"|Every 2 cycles, up to 1 year|||patients|||Number
165581|NCT00201864|Primary|Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.|TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Every 2 cycles up to 2 years|||months||95% Confidence Interval|Median
165582|NCT00201851|Primary|Disease-free Survival|5-year disease-free survival|two- to three-year accrual and initial two or more years of follow-up period|||percentage of participants|||Number
165583|NCT00201838|Secondary|Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines||up to 6 months|Compare CBR with responders and non responders with available blood samples.||delta Ct values||Standard Deviation|Mean
165584|NCT00201838|Secondary|Median Overall Survival Rates for Patients|Median survival is defined as the time of initiation of the first dose of intervention to the date of death|up to 1 year|all evaluable patients||months||95% Confidence Interval|Median
165585|NCT00201838|Secondary|Percentage of Patients With Clinical Benefit Response|A clinical benefit was defined by the improvement of at least one parameter over at least 4 weeks, without worsening of any other parameter (change in weight, ECOG performance status, Quality of life).|Up to 12 months|All evaluable patients||percentage of patients|||Number
165586|NCT00201838|Secondary|Number of Patients With Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 months|"2 patients in the control group were non evaluable for disease response due to patient withdrawal and another no baseline imaging for comparison.~5 patients in experimental group were non evaluable for response."||percentage of patients|||Number
165587|NCT00201838|Primary|Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Percentages were calculated by a Kaplan Meier analysis.|up to 6 months|5 patients of the experimental group were non evaluable and 2 patients in the control group were non evaluable for disease progression.||percent of patients with PFS|||Number
165588|NCT00201825|Secondary|Pharmacokinetics||Cycle 2|No Pharmacokinetics were conducted for this trial.|||||
165589|NCT00201825|Secondary|One Year Survival||one year|||months||95% Confidence Interval|Median
165590|NCT00201825|Secondary|Time to Tumor Progression||Every 35 days|||months||95% Confidence Interval|Median
165591|NCT00201825|Primary|Determine Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 35 days|One patient was not evaluable for response because the patient was removed from study afer an adverse event.||patients|||Number
165770|NCT00197392|Secondary|Device Related Adverse Events|Number of Device Related Adverse Events|Implanted subjects to time of explant|There were 8 device-related events, 7 of which were in subjects that received a standard catheter. None of the 8 subjects were proven infections.||events|||Number
165592|NCT00201773|Secondary|Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, <30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 16 weeks|Clinical Response was determined by physical exam and breast Ultrasound at baseline and repeated at 8 weeks and 16 weeks, and pathological response by histopathological examination of primary tumor and axillary nodes after definitive breast cancer surgery.||patients|||Number
165593|NCT00201773|Primary|Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane|Collected from postmenopausal women that receive neoadjuvant exemestane.|up to 16 weeks|Comparison of immunohistochemistry (IHC) Allred Differences with Neoadjuvant Therapy||patients|||Number
165594|NCT00201734|Secondary|Time to Tumor Progression for Patients|For patients enrolled on the Phase II portion of the trial the time to progression was measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression or the date of death if the patient dies due to causes other than disease progression.|Up to 6 years|||months||95% Confidence Interval|Median
165595|NCT00201734|Secondary|One Year Survival for Patients|For patients enrolled on the Phase II portion of the trial the One-year survival was measured as the percentage of patients alive 1 year after their treatment in the trial.|Up to 1 year|||percent of patients||95% Confidence Interval|Number
165596|NCT00201734|Secondary|Progression-Free Survival at 6 Months for Patients|For patients enrolled on the Phase II portion of the trial Progression Free Survival (PFS) was measured from the percentage of patients that were still alive, without evidence of disease progression for 6 months following the initiation of treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 6 years|||percent of patients||95% Confidence Interval|Number
165597|NCT00201734|Secondary|Phase I: To Determine Side Effects|The common clinically significant grade 3 and 4 toxicities graded using the National Cancer Institutes Common Toxicity Criteria version 3.0|Every 3 weeks, for up to 24 weeks|Three patients enrolled on Phase I portion of trial were not evaluable for toxicity.||percent of patients|||Number
165598|NCT00201734|Primary|Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 3 weeks, for up to 24 weeks|The Phase II study was prematurely terminated at 25 patients due to cessation of funding||percent of patients||95% Confidence Interval|Number
165599|NCT00201734|Primary|Maximum Tolerated Dose in Phase I Portion of Study|Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin.|Every 3 weeks, for up to 24 weeks|||mg/m2|||Number
165600|NCT00201643|Secondary|Maternal Infectious Morbidity.|Total number of Mothers having Maternal infectious morbidity (e.g. endometritis & maternal sepsis) noted from birth through 28 days after birth|Up to 28 days after giving birth|ITT||participants|||Number
165601|NCT00201643|Secondary|Number of Neonates With Pneumothorax|Total number of neonates with pneumothorax diagnosed postpartum.|birth to 28 days of life|ITT||participants|||Number
165602|NCT00201643|Secondary|Number of Neonates Who Required Surfactant Therapy After Birth.|The Number of neonates who required surfactant therapy within the first 28 days after birth.|Birth to 28 days of life|ITT||participant|||Number
165603|NCT00201643|Secondary|Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.|The number of babies who required ventilatory support within the first 28 days of life. Equal to or great than 12 hours was considered one day.|birth to 28 days of life|Intent to treat (ITT)||participants|||Number
165604|NCT00201643|Secondary|Neonatal Head Circumference Taken at Time of Birth.|Reported as the average of all neonatal head circumferences (HC) taken at time of birth in each group.|Birth|Intent to treat||centemeters (cm)||Standard Deviation|Mean
165605|NCT00201643|Secondary|Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.|Noted as the total number of Neonates delivering at < 34 weeks gestation for which their weights fell within the 10th percentile at time of birth.|Measured at birth.|Intent to Treat||paticipants|||Number
165606|NCT00201643|Secondary|Neonatal Birth Weight Reported in Grams|Measured mean Birth weights of Neonates in each arm as reported in grams on the birth record.|At time of Birth|Intent to treat protocol||grams||Standard Deviation|Mean
165607|NCT00201643|Secondary|Gestational Age at (@) Delivery|Reported the average/mean Neonatal gestational age (GA) (reported in weeks of pregnancy) at the time of birth for both groups (ACS vs. Placebo).|gestational age at delivery in weeks of gestation|Modified intent to treat||Weeks||Standard Deviation|Mean
165608|NCT00201643|Primary|Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.|This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at < 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death|From birth to 28 days of life|This was an intent to treat protocol. In patients delivering before 34 weeks we estimated that the sample size of at least 217 subjects in each arm would be needed to have 80% power to detect a 40% reduction in neonatal morbidity (to 16.8%).||participants|||Number
165609|NCT00201448|Primary|Immunology Response|The primary objective of the study is to evaluate safety and immune responses induced by the Towne vaccine in in seronegative women with children in daycare|Urine, saliva, will be collected every 2 months for 12 months and serum will be collected 1,2,4,6, 9, 12, 18, 24, 30 and 36 months after vaccination.|Study was terminated (suspended due to lack of funding). PI is no longer with the institution; data and results cannot be accessed, analyzed, and reported.|||||
165610|NCT00201448|Primary|Participants With Adverse Events||One year|per protocol and randomized||participants|||Number
165612|NCT00201409|Secondary|Oxygenation Index Change at Day 15 From Day 1|The oxygenation index is a calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body. It is calculated as the fraction of inspired oxygen times Mean airway pressure)/Partial pressure of oxygen in arterial blood Day 15 minus first day drug or placebo administered (Day 1).|Day 1, Day 15|||oxygenation index||Standard Deviation|Mean
165613|NCT00201409|Primary|Ventilator-free Days During Days 1-28||Measured at Day 28|||Days||Standard Deviation|Mean
165614|NCT00201240|Secondary|Post-transplant Lymphoproliferative Disorder (PTLD)|PTLD is defined as increased Epstein Barr Virus viremia requiring clinical intervention.|Year 2|||participants|||Number
165615|NCT00201240|Secondary|CD34+ and CD3+ Cell Doses|Total CD34+ and CD3+ cell doses will be calculated based on results of flow cytometric analysis.|Day 0|||cells per kilogram||Full Range|Median
165616|NCT00201240|Secondary|Overall Survival|Overall survival is defined as time from transplant to death or last follow-up.|Months 12 and 36|||percentage of participants||95% Confidence Interval|Number
165617|NCT00201240|Secondary|Disease-free Survival (DFS)|DFS is defined as the minimum time interval of times to relapse/recurrence, to death or to the last follow-up, from the time of transplant.|Months 6, 12, and 36|||percentage of participants||95% Confidence Interval|Number
165618|NCT00201240|Secondary|Determination of Infusional Toxicity||28 day|No data collected|||||
165619|NCT00201240|Secondary|Transplant Related Mortality|Death occurring in a patient in continuing complete remission.|Months 12, 24, and 36|||percentage of participants||95% Confidence Interval|Number
165620|NCT00201240|Secondary|Chronic Graft Versus Host Disease (GVHD)|Incidence and severity of chronic GVHD will be scored according to the BMT CTN MOP.|Year 2|||percentage of participants||95% Confidence Interval|Number
165621|NCT00201240|Secondary|Acute Graft Versus Host Disease (GVHD)|Incidence and severity of acute GVHD will be graded according to the BMT CTN MOP.|Day 100|||percentage of participants||95% Confidence Interval|Number
165622|NCT00201240|Secondary|Graft Failure|Primary graft failure is defined as the failure to achieve an ANC > 500 cells/µL by Day +30. Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in neutrophil counts < 500 cells/µL, unresponsive to growth factor therapy.|Day 100|||participants|||Number
165623|NCT00201240|Secondary|Platelet Engraftment|Time to platelet engraftment is measured by determining the first of three consecutive measurements of platelet count ≥ 20,000/uL without platelet transfusion support for seven days, starting from Day 0.|6 Months|||days||Full Range|Median
165624|NCT00201240|Secondary|Neutrophil Engraftment|Time to neutrophil engraftment is measured by determining the first of three consecutive measurements of absolute neutrophil count ≥ 500/uL following conditioning regimen induced nadir, starting from Day 0.|28 day|||days||Full Range|Median
165625|NCT00201240|Secondary|Leukemia Relapse|To assess the incidence of acute leukemia relapse from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval. Death prior to relapse will be considered as a competing risk.|Months 12 and 36|||percentage of participants||95% Confidence Interval|Number
165626|NCT00201240|Primary|Probability of Disease-free Survival (DFS) at 6 Months Post-transplant (Death or Relapse Will be Considered Events for This Endpoint)|The primary analysis will consist of estimating the 6-month DFS (from day of enrollment) probability based on the Kaplan-Meier product limit estimator. The 6-month DFS probability and confidence interval will be calculated. All registered patients will be considered for this analysis.|6 months|All transplanted patients||percentage of patients||95% Confidence Interval|Number
165627|NCT00201201|Secondary|Satisfaction With the APRN Provider Relationship|The Healthcare Relationships Scale assesses the perceived communication relationship with a provider. The 5-item instrument, based on two qualitative studies addresses patient-provider communication (2 questions), trust, decision-making related to care, and satisfaction with care. The scale was modified for use with older adults by changing the visual analog 10 cm response format to 5-point Likert-type responses with two extremes (e.g., 1:“not at all easy” to 5: “very easy”).|Measured at 0, 12 weeks on visit 1 and 4|There 69 participants in the control group and 82 participants in the education intervention group who chose to complete the satisfaction with the APRN provider on visit one and 65 in the control group and 75 in the education intervention group who chose to complete the survey on visit 4.||units on a scale of 1-5||Standard Deviation|Mean
165628|NCT00201201|Secondary|Satisfaction With the PEP-NG|"The PEP-NG user Satisfaction scale is a 14-item instrument – with eight items addressing the ease of program use, program content, and suitability of program content – and another six items addressing the intent to change behavior following program use. Ratings reflected by the 5-point Likert-type scale (ranging from 1, strongly disagree to 5, strongly agree) were summed and divided by the number of items answered to ensure that the overall Satisfaction scale was not affected by omitted items and was cast in the original 5-point metric. The higher the score on the instrument, the higher the degree of satisfaction with the PEP-NG."|Measured at 12 weeks|||units on a scale||Standard Deviation|Mean
165629|NCT00201201|Secondary|Prescription/Over the Counter (Rx-OTC) Knowledge|The OTC-Rx Knowledge scale has 14 multiple-choice items and the score is the percent of the items with correct response (range: 0-100%; these items test both knowledge and application concerning potential adverse effects of self-medication with OTC agents, supplements, or alcohol in persons with hypertension. The higher the score, the higher the knowledge of the potential adverse effects from self-medication.|Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4|||percentage of questions correct||Standard Deviation|Mean
165630|NCT00201201|Secondary|Self-efficacy for Avoiding Adverse Self-medication Behaviors|"The Self-efficacy scale is a 12-item instrument with statements reflecting patient confidence in selecting appropriate OTC agents and supplements, aside from avoiding adverse effects arising from self-medication behaviors. This scale has 5-point self-report response categories (ranging from 1, Not Sure to 5, Totally Sure). Responses were summed and divided by the number of items answered, so that the overall score would not be affected by omitted items and was reported based on the original 5-point metric. The higher the score on the instrument, the higher the degree of self-efficacy for avoiding adverse self-medication behaviors."|Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4|||units on a scale||Standard Deviation|Mean
165631|NCT00201201|Primary|Blood Pressure (BP) Readings: Systolic Blood Pressure|BP measurements were taken by the APRN at each of 4 visits – at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.|Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4|||mm Hg||Standard Deviation|Mean
165632|NCT00201201|Primary|Behaviors Risk Score|"Using a five-point scale from 1, very unlikely to 5, very likely, a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors."|Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4|||units on a scale||Standard Deviation|Mean
165633|NCT00201123|Secondary|Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.||cells/mL||Inter-Quartile Range|Median
165634|NCT00201123|Secondary|Chest Cavity Size||16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.||millimeters||Standard Deviation|Mean
165635|NCT00201123|Primary|Sputum Conversion||Measured at 16 Weeks|Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.||percentage of participants|||Number
165636|NCT00201006|Primary|Change in Body Weight.|Change in body weight during the 12-month period following completion of a 6-month lifestyle treatment for obesity.|one year|Data from all randomized participants were analyzed according to the Intent to Treatment principle. Missing data (6%) were completed based on known pattern of weight regain (i.e., 0.3 kg per month).||kg||Standard Error|Mean
165637|NCT00200967|Secondary|Asthma Control Questionnaire (ACQ)|Change between placebo salmeterol and active salmeterol for ACQ, where ACQ ranges from 0 (best asthma control) to 6 (worst asthma control).|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||units on a scale||95% Confidence Interval|Least Squares Mean
165638|NCT00200967|Secondary|Methacholine Provocative Concentration 20 (PC20)|Change between placebo salmeterol and active salmeterol for methacholine PC20|Clinic visits at weeks 0 and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||milligrams per milliliter||95% Confidence Interval|Geometric Mean
165639|NCT00200967|Secondary|Exhaled Breath Condensate (EBC)|Change between placebo salmeterol and active salmeterol for EBC|Clinic visits at weeks 0, 10, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||pH||95% Confidence Interval|Least Squares Mean
165640|NCT00200967|Secondary|Exhaled Nitric Oxide (eNO)|Change between placebo salmeterol and active salmeterol for eNO|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||parts per billion||95% Confidence Interval|Geometric Mean
165641|NCT00200967|Secondary|Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters per minute||95% Confidence Interval|Least Squares Mean
165642|NCT00200967|Secondary|Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters||95% Confidence Interval|Least Squares Mean
165643|NCT00200967|Secondary|Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator|Change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator|Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters||95% Confidence Interval|Least Squares Mean
165644|NCT00200967|Secondary|Rescue Medication (Ipratropium and Albuterol) Use|Change between placebo salmeterol and active salmeterol for rescue medication use|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||puffs per day||95% Confidence Interval|Mean
165645|NCT00200967|Secondary|Asthma Symptoms|Change between placebo salmeterol and active salmeterol for asthma symptoms (0=absent, 1=mild, 2=moderate, 3=severe).|Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||units on a scale||95% Confidence Interval|Mean
165646|NCT00200967|Secondary|Peak Expiratory Flow (PEF) Variability|Change between placebo salmeterol and active salmeterol for PEF variability, where PEF variability is defined as 100% x (PM PEF - AM PEF)/(PM PEF)|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||percentage||95% Confidence Interval|Least Squares Mean
165647|NCT00200967|Secondary|Evening (PM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for PM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An ITT paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters per minute||95% Confidence Interval|Least Squares Mean
165712|NCT00198081|Secondary|Number of Participants With Clinical Changes in IPMN Progression.|Examine the short term effect of celecoxib on clinical progression of IPMN in the surgical arm; Examine the long term effect of celecoxib on clinical progression of IPMN in the medical arm.|Baseline, 6 months, 1 year|Data never collected for surgical arm; medical arm of study never initiated.|||||
165648|NCT00200967|Primary|Morning (AM) Peak Expiratory Flow (PEF) Rate|Change between placebo salmeterol and active salmeterol for AM PEF rate|Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period|An intention-to-treat (ITT) paradigm was invoked in which the available data (without any imputation for missing data) on all randomized participants were included.||liters per minute||95% Confidence Interval|Least Squares Mean
165649|NCT00200785|Secondary|Electrical Impedance in Ohms|Electrical impedance (ohms) was measured using 0.5 mL of whole blood plus 0.5 mL saline in a Chronolog Whole Blood aggregometer. Ten mL of whole blood were collected and tested every week. There is no mathematical correlation between impedance (ohms) and percent aggregation.|4 weeks|"Nine persons participated in the high allicin test. Six of the same persons participated in the no allicin test."||ohms||Standard Deviation|Mean
165650|NCT00200785|Primary|Percent Platelet Aggregation|percent platelet aggregation in collagen-induced platelet aggregation in platelet rich plasma (PRP)|4 weeks|||percent platelet aggregation||Standard Deviation|Mean
165651|NCT00200356|Secondary|Modified Rankin Scale Score|The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|6 months|||participants|||Number
165652|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 3 Months|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation.|3 months|||units on a scale||Standard Deviation|Mean
165653|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 1 Month|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation.|1 month|||units on a scale||Standard Deviation|Mean
165654|NCT00200356|Secondary|Japan Stroke Scale (Motor Function) Score at 14 Days|The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation.|14 days|||units on a scale||Standard Deviation|Mean
165655|NCT00200356|Secondary|NIH Stroke Scale Score at 3 Months|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation.|3 months|||participants|||Number
165656|NCT00200356|Primary|the Rate of Patients With a Modified Rankin Scale Score of 0-1|The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|3 months|||participants|||Number
165657|NCT00200356|Secondary|NIH Stroke Scale Score at 1 Month|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation.|1 month|||participants|||Number
165658|NCT00200356|Secondary|NIH Stroke Scale Score at 14 Days|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation.|14 days|||participants|||Number
165659|NCT00200356|Secondary|Baseline NIH Stroke Scale Score|The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead).|Before treatment initiation|||scores on a scale||Standard Deviation|Mean
165660|NCT00200356|Secondary|Barthel Index Score|"The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.~The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation."|3 months|||participants|||Number
165661|NCT00200343|Secondary|Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100||Percentage of change||Full Range|Median
165662|NCT00200343|Primary|Percentage Change of Alanine Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100||Percentage of change||Full Range|Median
165663|NCT00200343|Secondary|Gamma-glutamyl Transpeptidase at Baseline||0 week|||IU/L||Standard Deviation|Mean
165664|NCT00200343|Secondary|Percentage Change of Aspartate Aminotransferase From Baseline at Week 24|Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100|24 weeks (from baseline to Week 24)|||Percentage of change||Full Range|Median
165665|NCT00200343|Secondary|Aspartate Aminotransferase at Baseline||0 week|||IU/L||Standard Deviation|Mean
165666|NCT00200343|Primary|Alanine Aminotransferase at Baseline||0 week|10 patients were excluded from analysis population due to luck of sufficient data.||IU/L||Standard Deviation|Mean
165713|NCT00198081|Primary|Concentration of PGE2 in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
165667|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of urgent incontinent episodes per week from baseline to 12 months."|Baseline and 12 months|All subjects who were successfully implanted were included in this analysis. The modified worst-case analysis for missing data was used, so that all subjects with missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.||proportion of subjects||95% Confidence Interval|Mean
165668|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
165669|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
165670|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 Months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
165671|NCT00200057|Secondary|Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle|This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.||units on a scale||Standard Deviation|Mean
165672|NCT00200057|Secondary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week|"This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent days per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.||proportion of subjects||95% Confidence Interval|Mean
165673|NCT00200057|Primary|Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week|"The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered successes.~The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months."|Baseline and 12 months|All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.||proportion of subjects||95% Confidence Interval|Mean
165674|NCT00199914|Secondary|Adverse Events||3 weeks||||||
165675|NCT00199914|Secondary|Patient's Satisfaction to the Treatment||3 weeks||||||
165676|NCT00199914|Secondary|Global Improvement||3 weeks||||||
165677|NCT00199914|Secondary|Gait Speed (Calculated From the Time Spending for 100-meter Walk)||3 weeks||||||
165697|NCT00197106|Secondary|Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26|PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. From this population, only participants who had measurements at both baseline and Week 26 have been used for analysis.||ratio||95% Confidence Interval|Log Mean
165678|NCT00199914|Primary|The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index|The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale [11, 23]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The higher score reflects worse pain and stiffness and poorer physical function.|3 weeks|Statistical analyses to test the superiority were based on the intention-to-treat (ITT) population, and those chosen to demonstrate the equivalence were based on the per protocol population. The “worst –case-scenario” was applied to the dropouts in the ITT analyses.||units on a scale||95% Confidence Interval|Mean
165679|NCT00199381|Primary|Safety as Measured by Adverse Events|Investigation of the long-term tolerability and safety of istradefylline|Every 2 months up to 32 months|Safety analysis set - all subjects who took at least one dose of study drug. 1 subject of the 504 enrolled did not take study drug and is not included in the safety analysis set.||participants|||Number
165680|NCT00198822|Secondary|Plasma Retinol at the Third Trimester of Pregnancy (Nutritional Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gestation)|||micromoles per liter||Standard Deviation|Mean
165681|NCT00198822|Primary|All-cause, Pregnancy-related Mortality|Mortality evaluated on intent-to-treat basis|Deaths during pregnancy through 12 weeks postpartum|As the study ended on the advice of the Data and Safety Monitoring Board, based on evidence of no difference, all enrolled women who had a chance of being followed through 84 days after the end of their pregnancy were included in the trial. The cohort included pregnancies identified between August 17, 2001 and January 5, 2006.||Participants|||Number
165682|NCT00198822|Secondary|Plasma Beta-carotene in the Third Trimester of Pregnancy(Nutritonal Status of the Mother)||Third trimester of pregnancy (about the 32nd week of gesatation)|||Plasma beta-carotene micromoles / liter||Standard Deviation|Mean
165683|NCT00198822|Secondary|Infant Morbidity Through 3 Months of Age||within 24 weeks after birth||||||
165684|NCT00198822|Secondary|Fetal Growth and Postnatal Infant Growth Through Three Months of Age||through the 1st 12 weeks after birth||||||
165685|NCT00198822|Secondary|Gestational Age at Birth||within 24 weeks after birth||||||
165686|NCT00198822|Secondary|Maternal Morbidity, Including Obstetric Complications||through the 1st 24 weeks following termination of pregnancy||||||
165687|NCT00198822|Secondary|All-cause 3-month Infant Mortality||Deaths through the 1st 12 weeks of life|Mortality evaluated on intent-to-treat basis||participants|||Number
165688|NCT00197119|Primary|Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From Year 6 through to Year 10|||subjects|||Number
165689|NCT00197119|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value|Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the ATP cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.||subjects|||Number
165690|NCT00197119|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value|Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).|Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination|Analysis was performed on the Long Term According To Protocol (ATP) cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.||subjects|||Number
165691|NCT00197106|Secondary|Time to Asthma Control, Defined as the Time to First ‘Good Controlled Week’ or ‘Maximum Controlled Week'|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||days||Standard Deviation|Mean
165692|NCT00197106|Secondary|Weekly Percentage of Participants With ‘Good Controlled Weeks’ and ‘Maximal Controlled Weeks’|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||percentage of participants|||Number
165693|NCT00197106|Secondary|Cumulative Number of Symptom-free Weeks Until the End of Treatment|This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.|26 weeks|||number of symptom-free weeks|||Number
165694|NCT00197106|Secondary|Frequency of Asthma Exacerbations (Discriminated on Severity)|The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.|26 weeks|||number of exacerbations|||Number
165695|NCT00197106|Secondary|Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)|Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.|26 weeks|||liters/second||Standard Deviation|Mean
165696|NCT00197106|Secondary|Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres|Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.|26 weeks|||number of exacerbations|||Number
165698|NCT00197106|Secondary|Number of Asthma Exacerbations Per Treatment Group at Week 26|An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.|Week 26|Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication)||number of exacerbations|||Number
165699|NCT00197106|Secondary|Percent Change From Baseline in RINT Measurements at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.|Baseline and Week 26|PP Population: Intent-to-Treat (ITT) Population participants who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26). For some participants, the data for the RINT measurement are missing, either at Baseline or at Week 26. As a result, fewer subjects have been included in the analysis.||percent|||Number
165700|NCT00197106|Secondary|Geometric Means of Nitric Oxide (NO) at Week 26|Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26)||parts per billion||Full Range|Geometric Mean
165701|NCT00197106|Secondary|Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. For some participants, the data for the MEF 50 measurements are missing, resulting in a smaller number of participants analyzed.||liters/second||Standard Deviation|Mean
165702|NCT00197106|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.||liters||Standard Deviation|Mean
165703|NCT00197106|Secondary|Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26|Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.|Baseline and Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.||percent predicted change||Standard Deviation|Mean
165704|NCT00197106|Secondary|Percentage of Symptom-free Days During the Entire Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary|Baseline to Week 26|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations||percentage of days||Standard Deviation|Mean
165705|NCT00197106|Primary|Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period|Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary.|Last 10 weeks of the treatment period (Weeks 16-26)|Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations||percentage of days||Standard Deviation|Mean
165706|NCT00198133|Secondary|Grade 3/4 Treatment Related Adverse Events|To determine the toxicity of premetrexed in this patient population, the number of patients who experienced grade 3 or 4 adverse events will be reported that were treatment related (possibly, probably, definitely).|Up to 3 years|All patients enrolled and received treatment||participants|||Number
165707|NCT00198133|Secondary|Duration of Remission|Will be examined using Kaplan-Meier estimates. Time from earliest confirmed remission criteria until death or progression will be calculated. If a patient continued to be in remission at the end of the study, they will be censored at their last evaluation in the analysis.|Time from the date of remission until progression or death, assessed up to 3 years|All patients with at least one post baseline measurement who had a response of CR or PR||months||95% Confidence Interval|Median
165708|NCT00198133|Primary|Objective Response Rate (Complete and Partial Response)|The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.|Up to 3 years|All patients with at least one post baseline measurement. (26 evaluable – 15 T and 11 TC patients)||percentage of participants||95% Confidence Interval|Number
165709|NCT00198081|Primary|Concentration of PGEM in Serum at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
165710|NCT00198081|Primary|Concentration of PGEM in Urine at Baseline, Surgery, 1 wk, 4wks, and 6 Months|Measured by Elisa at participant level - only participant level data available; not summarized across group|Baseline, surgery, 1 wk, 4 wks, and 6 months|||pg/ml|||Number
165714|NCT00198029|Secondary|Visual Analog Scale for Pain|The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.|26 weeks (6 months)|||mm||Standard Deviation|Mean
165715|NCT00198029|Primary|The Disabilities of the Arm, Shoulder and Hand Outcome Measure|The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.|26 weeks (6 months)|||units on a scale||Standard Deviation|Mean
165716|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
165717|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
165718|NCT00197028|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
165719|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
165720|NCT00197028|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
165721|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
165722|NCT00197028|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain and swelling at injection site.|During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.||subjects|||Number
165723|NCT00197028|Secondary|Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia|The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.||Parasites per µL||Full Range|Mean
165724|NCT00197028|Secondary|Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum)|Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.|At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.||subjects|||Number
165735|NCT00197015|Secondary|Number of Subjects Reporting New Chronic Illnesses|New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).||subjects|||Number
165725|NCT00197028|Secondary|Time to First Malaria Infection|Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.|Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6)|The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.||n/PYAR|||Number
165726|NCT00197028|Secondary|Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||µg/mL||95% Confidence Interval|Geometric Mean
165727|NCT00197028|Secondary|Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 15 EL.U/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
165728|NCT00197028|Secondary|Concentrations of Antibodies Against Tetanus (Anti-T)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||IU/mL||95% Confidence Interval|Geometric Mean
165729|NCT00197028|Secondary|Concentrations of Antibodies Against Anti-diphtheria (Anti-D)|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||IU/mL||95% Confidence Interval|Geometric Mean
165730|NCT00197028|Secondary|Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 EL.U/mL.|Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
165731|NCT00197028|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HB)|Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/mL.|Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.||mIU/mL||95% Confidence Interval|Geometric Mean
165732|NCT00197028|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|Throughout the entire study period (from Month 0 to Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
165733|NCT00197028|Primary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
165734|NCT00197015|Secondary|Number of Subjects Reporting Medically Significant Events|Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination).|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort (for the Active Phase) and the Extended Safety Follow-up cohort (for the Extended Safety Follow-up Phase).||subjects|||Number
165736|NCT00197015|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)|Analysis was performed on the Total Vaccinated cohort.||subjects|||Number
165737|NCT00197015|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|During the 31-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort.||subjects|||Number
165738|NCT00197015|Primary|Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).|42 days following administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.||subjects|||Number
165739|NCT00197015|Primary|Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups|Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.||subjects|||Number
165740|NCT00197015|Secondary|Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events|Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures.|During the 43-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects from MMR+V→HAV and HAV+MMR+V groups.||subjects|||Number
165741|NCT00197015|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.||subjects|||Number
165742|NCT00197015|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, rash (local), redness and swelling.|During the 4-day period following each dose of vaccine|Analysis was performed on the Total Vaccinated cohort, on subjects with available data.||subjects|||Number
165743|NCT00197015|Secondary|Number of Subjects With Vaccine Response to Havrix®|Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive.|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.||subjects|||Number
165744|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.||subjects|||Number
165745|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group|Concentrations are given as geometric mean concentrations (GMCs).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from MMR+V→HAV Group.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
165746|NCT00197015|Secondary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.||subjects|||Number
165747|NCT00197015|Secondary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups|Concentrations are given as geometric mean concentrations (GMCs).|42 days following the first dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
165748|NCT00197015|Secondary|Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups|Titers are given as geometric mean titers (GMTs).|42 days following the administration of M-M-R®II and VARIVAX®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV+MMR+V and MMR+V→HAV groups.||titers||95% Confidence Interval|Geometric Mean
165749|NCT00197015|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups|Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V groups.||subjects|||Number
165750|NCT00197015|Primary|Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.|Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).|31 days following the second dose of Havrix®|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results from HAV and HAV+MMR+V Groups.||mIU/mL||95% Confidence Interval|Geometric Mean
165751|NCT00196937|Secondary|Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSAEs)|NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.|During the entire study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).||subjects|||Number
165752|NCT00196937|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period (up to Month 48)|Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).||subjects|||Number
165753|NCT00196937|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day (Days 0-29) period following each vaccination|||subjects|||Number
165754|NCT00196937|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.||subjects|||Number
165755|NCT00196937|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) period following each vaccination|Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.||subjects|||Number
165756|NCT00196937|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After 2 Vaccine Doses and 6 Months Following the Complete Vaccination Course|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Seroconversion results at Month 7 (1 month after the complete vaccination course) are already presented above as primary outcome measure #1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and as secondary outcome measure #6 for Cervarix (46-55 Years) Group."|At Month 2 and Month 12|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity.||subjects|||Number
165757|NCT00196937|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Seroconversion results at Month 7 for the other 2 groups are already presented in the primary outcome measure #1."|At Month 7|Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity with available data.||subjects|||Number
165758|NCT00196937|Secondary|Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion)|Seropositivity is defined as total IgG above or equal to 0 microgram per milliliter (µg/mL).|At Months 18 and 24|Analysis was performed on the Cervicovaginal samples subset cohort, including subjects for whom cervicovaginal secretion samples with less than 80 erythrocytes per milliliter were collected and results were available for Months 18 and/or 24.||subjects|||Number
165759|NCT00196937|Secondary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervical Samples|Titer given as GMT.|At Months 18 and 24|Analysis was performed on subjects from the Total vaccinated for whom cervical secretions results were available for Months 18 and/or 24.||EL.U/mL||95% Confidence Interval|Geometric Mean
165760|NCT00196937|Primary|Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies|"Titer given as geometric mean titer (GMT).~Primary outcome measure assessed at Month 18, 24, 36, and 48."|Before vaccination (PRE) and at Months 2, 7, 12, 18, 24, 36 and 48|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data at the defined timepoint.||EL.U/mL||95% Confidence Interval|Geometric Mean
165761|NCT00196937|Primary|Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age|"Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.~Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Seroconversion at Month 7 was a secondary outcome measure as per protocol for Cervarix (46-55 Years) Group."|At Month 7|Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data for the Cervarix (46-55 Years) Group are presented in the Outcome #6.||subjects|||Number
165762|NCT00197392|Secondary|Number of Catheter Insertion Attempts|Number of insertions needed to place catheter|Implantation of subject|||insertions|||Number
165763|NCT00197392|Secondary|Length of Catheter Tunneling Into the Brain|Length of tunneling of EVD catheter in the brain for each analysis population.|Implant of subject|||cm||Standard Deviation|Mean
165764|NCT00197392|Secondary|Hospital Locations for EVD Catheter Placement|Number of subjects in each analysis population where the EVD catheter placement occurred; either in the Intensive Care Unit (ICU)or the Operating Room (OR).|Implantation of subject|||Participants|||Number
165765|NCT00197392|Secondary|Time Point of Introduction of Systemic Antibiotic Therapy|Time points of then patients received systemic antibiotic therapy|Within 48 hours of implant of subjects to explant|||Paticipants|||Number
165766|NCT00197392|Secondary|Non-infectious Catheter Failure in the MITT Population|Reasons for non-infectious catheter malfunctions in the Modified intent to treat population.|Implant of subject to explant|||Participants|||Number
165767|NCT00197392|Secondary|Diagnosis Requiring EVD Implantation|Primary diagnosis for implantation of EVD system|Implantation of EVD system|Analysis consisted of combining both Arm/Group (Bactiseal and Standard)||Participants|||Number
165768|NCT00197392|Secondary|Average Subject Age|The average subject age|Implant to subject|||Years||Standard Deviation|Mean
165772|NCT00197392|Secondary|Class of Bacterial Agent Causing Proven Infection|Type of bacterial agent related to proven infection in Bactiseal EVD and Standard EVD|Implantation of subject to post implant|All subjects included in the MITT, Evaluable and Per-Protocol population.||participants|||Number
165773|NCT00197392|Secondary|Days to Proven Infection|Number of days to proven infection.|Implantation of EVD System to explant of EVD catheter, an average of ten days|||Days||Standard Deviation|Mean
165774|NCT00197392|Primary|Number of Infections|The number of infections for the Codman Bactiseal EVD Catheter and the number of infections for a Standard EVD Catheter (ventriculostomy-related infections).|Duration of implanted EVD system to 2 week post implant|||Infections|||Number
165775|NCT00197236|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events|Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.|Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.|The analyses were performed on the Total Vaccinated Cohort for the active phase of the study and on the Extended safety follow-up cohort for the 6-month extended follow-up (ESFU) phase.||subjects|||Number
165776|NCT00197236|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|31-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort||subjects|||Number
165777|NCT00197236|Secondary|Number of Subjects Reporting Solicited General Adverse Events (AEs)|Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
165778|NCT00197236|Primary|Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)|Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||subjects|||Number
165779|NCT00197236|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs)|Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.|4-day period following each dose of study vaccine(s)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.||subjects|||Number
165780|NCT00197236|Secondary|Number of Subjects With Vaccine Response to Havrix™.|Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.|31 days following the second dose|Analysis was performed on the According-to-Protocol cohort for immunogenicity||subjects|||Number
165781|NCT00197236|Secondary|Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity.||mIU/mL||95% Confidence Interval|Geometric Mean
165782|NCT00197236|Secondary|Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix|Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.||mIU/mL||95% Confidence Interval|Geometric Mean
165783|NCT00197236|Secondary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the first dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.||subjects|||Number
165784|NCT00197236|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)|Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||subjects|||Number
165785|NCT00197236|Secondary|Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as microgram/milliliter (µg/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||µg/mL||95% Confidence Interval|Geometric Mean
165786|NCT00197236|Secondary|Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)|GMCs are expressed as International Units per milliliter (IU/mL).|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||IU/mL||95% Confidence Interval|Geometric Mean
165798|NCT00196716|Secondary|Urine Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24 and Week 96. Urine GL-3 is often elevated in the urine of patients diagnosed with Fabry disease. This outcome measure evaluated the mean urine GL-3 in first morning void urine for all patients to see if it decreased while on Fabrazyme. Normal Urine GL-3 threshold was < 8.8 μg/mg.|Throughout study, 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||μg/mg||Standard Deviation|Mean
165787|NCT00197236|Primary|Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects|Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.|31 days following the administration of Infanrix™ and ActHIB|Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.||subjects|||Number
165788|NCT00197236|Primary|Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix|Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).|31 days following the second dose of Havrix™|Analysis was performed on the According-to-Protocol cohort for immunogenicity including subjects who had at least one study vaccine administered and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.||subjects|||Number
165789|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|At least one month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
165790|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30-day follow-up period after additional vaccination.|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
165791|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.|"Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.~Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination"|During the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
165792|NCT00197184|Secondary|Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.~Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful"|during the 4-day follow-up period after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||subjects|||Number
165793|NCT00197184|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.|"A serious adverse event (SAE) is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|From last study visit of the primary study up to Year 5 long term follow-up|The analysis was performed on the Long term Total vaccinated cohort wich included all subjects who returned at a specified follow-up study||subjects|||Number
165794|NCT00197184|Primary|Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix™ challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).|Before and One month after additional vaccination|Analysis was performed on the Total vaccinated cohort for the challenge dose, including all subjects who received an additional vaccine dose between 6 to 12 months after year 5.||mIU/mL||95% Confidence Interval|Geometric Mean
165795|NCT00197184|Primary|Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.|Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.|Before and one month after additional vaccination|None of the subjects became seronegative for anti-HAV antibodies during the Year 2 to Year 5 long term follow-up. Hence none of the subjects received an additional Havrix dose.|||||
165796|NCT00197184|Primary|Anti-hepatitis B (HBs) Antibody Concentrations|Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.||mIU/mL||95% Confidence Interval|Geometric Mean
165797|NCT00197184|Primary|Anti-hepatitis A (HAV) Antibody Concentrations|Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)|Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)|Analysis was performed on the Long Term According to Protocol cohort for analysis of immunogenicity (LT ATP immunogenicity cohort) which included all subjects that complied with the protocol and for whom data concerning immunogenicity endpoint measures were available for the particular time point measured.||mIU/mL||95% Confidence Interval|Geometric Mean
165881|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 70 (CR-70)|A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases||Percentage of participants|||Number
175709|NCT00073073|Secondary|Effect of This Drug on Serum Hormones, Insulin-like Growth Factor Pathway Components, and Leptin at 3 Months and 1 Year||3 months and 1 year|Data were not collected|||||
165799|NCT00196716|Secondary|Plasma Globotriaosylceramide (GL-3)|Evaluated at Baseline, Week 24, Week 48, Week 72 and Week 96. Plasma GL-3 is often elevated in the plasma of patients diagnosed with Fabry disease. This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level was <= 7.03 µg/mL.|Throughout study; 96 weeks|ITT population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||μg/mL||Standard Deviation|Mean
165800|NCT00196716|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Evaluated at Baseline, Week 24 and Week 96. eGFR is an estimation of the glomerular filtration rate of the kidneys (how much blood the kidneys are filtering). For this study, normal eGFR was defined as greater than 90 mL/min/1.73 m2|Throughout study; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||ml/min/1.73 m2||Standard Deviation|Mean
165801|NCT00196716|Secondary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 24, Week 48, Week 72, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study ; 96 weeks|ITT Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||Participants|||Number
165802|NCT00196716|Primary|Globotriaosylceramide (GL-3) Clearance in Kidney Interstitial Capillary Endothelium|Kidney biopsies were taken at Baseline, Week 24, and Week 96 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Throughout study; 96 weeks|Intent-to-Treat (ITT) Population. One patient switched back to 1.0 mg/kg Fabrazyme treatment at Week 76 and therefore assessments at Week 76 and thereafter for this patient were excluded from the analysis.||Participants|||Number
165803|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.~The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication.~Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication.~Three denominators are reported;~excluding cycles where other birth control methods (BCMs) was used~all complete cycles~compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.||pregnancies per 100 woman years exposure|||Number
165804|NCT00196326|Secondary|Participants With Treatment-Emergent Adverse Events|Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.|Day 1 up to one year|The safety cohort consisted of all patient who took at least one dose of study medication||participants|||Number
165805|NCT00196326|Primary|"Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining On Drug Pregnancy"|"Pearl Index= ((100)*(number of pregnancies)*(4 cycles/year))/number of 91-day cycles completed.~The pregnancy rate included on-drug pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication.~Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication.~Three denominators are reported;~excluding cycles where other birth control methods (BCMs) was used~all complete cycles~compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)"|up to one year|The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.||pregnancies per 100 woman years exposure|||Number
165806|NCT00196313|Secondary|Analgesic Use|number of days analgesic (pain) medication was used over the 13 week treatment period|13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||Days Analgesic was used over 13 weeks||Standard Deviation|Mean
165807|NCT00196313|Secondary|Number of Days Missed From School/Work or Other Activities||13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||Days||Standard Deviation|Mean
165808|NCT00196313|Secondary|Incidence of Menstrual Bleeding and /or Spotting||Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||Days of bleeding/spotting over 13 weeks||Standard Deviation|Mean
165809|NCT00196313|Secondary|Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain|"Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.~The severity of the pain was assessed using a 4-points scale (0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”)"|Baseline to end of Week 13|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||units on a scale||Standard Error|Least Squares Mean
175710|NCT00073073|Secondary|Change in Breast Density at 2 Years||2 years|||percent change from baseline||95% Confidence Interval|Mean
165810|NCT00196313|Primary|Mean Change in Average Severity for Abdominal/Pelvic Pain|Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = “None”, 1 = “Mild”, 2 = “Moderate”, 3 = “Severe”)|Baseline to end of 13-week treatment period|Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.||units on a scale||Standard Error|Least Squares Mean
165811|NCT00196196|Secondary|Percentage of Agreement Between the Codman Valve Position Verification (VPV) System and Consensus X-rays Using Various Thresholds|Percentage of agreement between consensus X-ray readings and the intended setting programmed by the Codman Valve Position Verification (VPV) system. This was assessed at various steps (intervals of mmH20) as increments allow on the Codman Hakim Programmable Valve. (1 step = 10 mmH20, 2 steps = 20 mmH20, +2 steps = >20 mmH20)|Day 1|||Percentage of agreement|||Number
165812|NCT00196196|Primary|"Percentage of Participants Who Achieved Adjustment Complete and a Consensus X-ray Reading"|"Up to 5 attempts to achieve Adjustment Complete using the Codman Valve Position Verification (VPV) system for each Subject. Agreement in 2 of 3 valve X-ray readings by independent radiologists for each Subject was considered consensus X-ray. All participants included achieved Adjustment Complete and a consensus X-ray reading."|Day 1|||Percentage of participants|||Number
165813|NCT00196105|Primary|Time to Death|Overall Survival|up to 32 months|||Days||Inter-Quartile Range|Median
165814|NCT00196105|Primary|Number of Deaths||up to 32 months|||Participants|||Number
165815|NCT00196105|Primary|Number of Days to Occlusion||up to 32 months|||Days||Full Range|Median
165816|NCT00196105|Primary|Closure or Blockage of the Stent (Occlusion)|"Biliary stents may become closed or blocked. This is also termed Occlusion. Data for this outcome measure involve stent occlusions that required re-intervention."|up to 32 months|||Stent Occlusions|||Number
165817|NCT00196105|Primary|Patency|Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).|up to 32 months|||Days||Full Range|Median
165818|NCT00195819|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Baseline and Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.||score on a scale||Standard Error|Mean
165819|NCT00195819|Secondary|Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Weeks 12 and 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.||score on a scale||Standard Error|Mean
165820|NCT00195819|Secondary|Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure|The S.P.A.R.C.C. MRI index is a tool for scoring inflammation and structural damage in both the spine and sacroiliac (SI) joints. The spinal SPARCC index score consists of 3 subscales (edema, intense edema, and deep edema). Edema was defined as the presence of increased STIR signal in each of 4 Discovertebral unit (DVU) quadrants and was assigned a score (0 = normal signal, 1 = increased signal). The scoring of edema was repeated for each of 3 consecutive sagittal slices with a maximum score of 12 per DVU (range for edema, 0-72). The total spinal SPARCC index score is 0 to 108.|Week 12 and Week 52|Intent-to-treat (ITT) - analysis of all subjects with at least one Baseline MRI were included in the ITT population.||score on a scale||Standard Error|Mean
165821|NCT00195819|Secondary|Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage degradation and bone resorption were assessed by evaluating changes in NTx. A decrease in NTx represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||NM BCE||Standard Deviation|Mean
165822|NCT00195819|Secondary|Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in CTX-II. A decrease in CTX-II represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||ng/mmolcr||Standard Deviation|Mean
165882|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Response 100 (CR-100)|A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Observed Cases||Percentage of participants|||Number
165823|NCT00195819|Secondary|Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure|Cartilage and bone degradation were assessed by evaluating changes in MMP-3. A decrease in MMP-3 represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||ng/mL||Standard Deviation|Mean
165824|NCT00195819|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The MCIS was a patient reported outcome where the subjects were expected to respond (yes/no) to the following question:~Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory? An increase in PASS indicates improvement.~During earlier weeks of the study PASS was measured/reported as minimal clinically important state (MCIS)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165825|NCT00195819|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life comprised of 18 questions to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are subjects with MCID <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165826|NCT00195819|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
165827|NCT00195819|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|Change from baseline in Health Utility Index Mark 3 (HUI-3) was reported. The HUI-3 is a generic approach to the measurement of health status and assessment of HRQL. The HUI-3 was comprised of two complementary components. The first component was a multi-attribute health status classification system that was used to describe health status. The second component was a multi-attribute utility function that was used to value health status as measured within the corresponding multi-attribute health status classification system. An increase in the HUI-3 score represents improvement.|Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
165828|NCT00195819|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey completed by Subject, evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Responders are subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165829|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). Change from Baseline in the SF-36 Health Survey Index was completed by Subject. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
167216|NCT00168844|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
165830|NCT00195819|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning)to 100 (highest level of functioning).~Responders were subjects with MCID > 3 points. Minimal clinically important difference (MCID) for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165831|NCT00195819|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure|Change from Baseline in the SF-36 Health Survey Index completed by Subject to help subject keep track of how he/she was feeling and how well he/she was able to do usual activities. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicate improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
165832|NCT00195819|Secondary|Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260|The FACIT-Fatigue scale: overall score of 13 general questions divided into four primary Quality of Life (QoL) domains: 1) Physical Well-Being, 2) Social/Family Well-Being, 3) Emotional Well-Being, and 4) Functional Well-Being. For each question subject rates his/her condition for the past week on a 5-point scale ranging from 0 (not at all) to 4 (very much). The score ranges from 0 (highest level of fatigue) to 52 with 52 being the lowest level of fatigue.|Baseline and at Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||unit on a scale||Standard Deviation|Mean
165833|NCT00195819|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
165834|NCT00195819|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a VAS scale with 0 being very good and 100 being very bad.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
165835|NCT00195819|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
165836|NCT00195819|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||score on scale||Standard Deviation|Mean
165837|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G consisted of two questions that asked the subject to indicate, on a 10 cm VAS, the effect the disease had on their well being over 1) last week, and 2) last 6 months. BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported. The mean of the two scores give a BAS-G score of 0-10.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
165838|NCT00195819|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||Units on a scale||Standard Deviation|Mean
165839|NCT00195819|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.~An increase in chest expansion represents improvement"|Weeks 12, 24, 52,104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
165840|NCT00195819|Secondary|Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260|The EDASMI is a composite spinal mobility index comprised of 4 measures: 1) cervical rotation, 2) lumbar side flexion, 3) chest expansion, and 4) hip internal rotation spread. A grade of 0-4 scoring system was developed for each of the measures. The sum of 4 items (range 0 to 16) provide the EDASMI score. Decrease in EDASMI represents improvement. All EDASMI measures were done with a simple tape measure and recorded in centimeters (cm) by a rheumatologist and a clinician nurse.|Weeks 12, 24, 52, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
165841|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
165842|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in BASDAI in subjects with adalimumab exposure from Baseline through 5 years for the effect of adalimumab on structural damage. Partial remission was calculated as follows: A value below 20 on a 0 - 100-point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165843|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.~ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 16, 20, 24, 30, 36, 42, 48, 52, 64, 76, 88, 104, 116, 128, 140, 156, 168, 180, 192, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165844|NCT00195819|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responder: improvement of >= 40% and absolute improvement of >= 20 units (on a scale of 0 to 100) in >= 3 of the 4 domains: Patient global assessment (VAS score [0-100 scale]); Pain (Total Back Pain VAS score 0-100 scale); Function (BASFI score 0-100 scale); Inflammation (the mean of the two morning stiffness-related BASDAI VAS scores (i.e. the average of items 5 and 6 of the BASDAI. Applied to each scale. In addition, absence of deterioration in the potential remaining domain, where deterioration is defined as a net worsening of > 0 units (on a scale of 0 to 100).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244 and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
167272|NCT00168831|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/Litre (L)||Standard Deviation|Mean
165845|NCT00195819|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicate reduction in inflammation. A decrease in CRP indicates improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mg/dL||Standard Deviation|Mean
165846|NCT00195819|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
165847|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165848|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165849|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 100(very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10)~BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||Participants|||Number
165850|NCT00195819|Secondary|Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe].|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||particpants|||Number
165851|NCT00195819|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI) of 0 (none) to 10 (very severe). A decrease in inflammation represents improvement.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
165883|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 204|Intent-to-treat, Observed Cases||Percentage of participants|||Number
165852|NCT00195819|Secondary|Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 128, 152, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165853|NCT00195819|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
165854|NCT00195819|Secondary|BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165855|NCT00195819|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 10 cm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 10 (impossible).|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
165856|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mmg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165857|NCT00195819|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Weeks 12, 24, 36, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
165858|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100[severe]) Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; 1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165859|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units (0-100) from Baseline in visual analog scale (VAS) for >=3 of the 4 domains; Patient's Global Assessment of disease activity; (0[none]-100[severe]) VAS scale; Total Back Pain VAS; (0 [no pain]-100 [severe]); BASFI VAS; (0 [easy ]-100[impossible]) and Inflammation VAS; (1 [no pain] to 10 [severe pain]). In addition, absence of deterioration in the potential remaining domain. Applied to each scale and not overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
167273|NCT00168831|Secondary|Change From Baseline in Red Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^12/Litre (L)||Standard Deviation|Mean
165860|NCT00195819|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all subjects who received at least one injection of adalimumab during the Study, in either the double-blind or the open label portion. 38 randomized to 40 mg adalimumab every other week (eow) and 44 randomized to placebo. The Any Adalimumab Set will be analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
165861|NCT00195819|Primary|Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) 0 [no disease activity]-100 [high disease activity]) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 [easy ]-100[impossible]); and Inflammation VAS; (1 [no pain] to 10 [severe pain]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Week 12|Full analysis set - includes all subjects who were randomized and received at least one injection of study medication. The full analysis set was analyzed by treatment group.||participants|||Number
165862|NCT00195715|Secondary|Percentage of Subjects With Fatal Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165863|NCT00195715|Secondary|Percentage of Subjects With Hematologic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165864|NCT00195715|Secondary|Percentage of Subjects With Lupus-like Syndrome||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165865|NCT00195715|Secondary|Percentage of Subjects With Allergic Reaction-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165866|NCT00195715|Secondary|Percentage of Subjects With Hepatic-related Adverse Event||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165867|NCT00195715|Secondary|Percentage of Subjects With Demyelinating Disease||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165868|NCT00195715|Secondary|Percentage of Subjects With Congestive Heart Failure||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of subjects|||Number
165869|NCT00195715|Secondary|Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165870|NCT00195715|Secondary|Percentage of Subjects With Injection Site Reaction-related Adverse Event|"An injection site reaction is any adverse event corresponding to a preferred term beginning with injection site excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration."|Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165871|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165872|NCT00195715|Secondary|Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165873|NCT00195715|Secondary|Percentage of Subjects With Nonmelanoma Skin Cancer||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165874|NCT00195715|Secondary|Percentage of Subjects With Lymphoma||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165875|NCT00195715|Secondary|Percentage of Subjects With Malignancy||Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165876|NCT00195715|Secondary|Percentage of Subjects With Serious Infection|Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.|Up to 262 weeks of adalimumab treatment|Safety population||Percentage of participants|||Number
165877|NCT00195715|Secondary|Percentage of Subjects With Infection||Up to 262 weeks of adalimumab treatment|Safety population, defined as all subjects who received at least 1 dose of study drug||Percentage of participants|||Number
165878|NCT00195715|Secondary|Percentage of Subjects With Fistula Remission|Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.|Week 156|Intent-to-treat, Subjects with fistulas present at baseline of the preceding study, Observed Cases||Percentage of participants|||Number
165879|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free CR-100|Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with corticosteroid use at baseline of preceding study, Observed Cases||Percentage of participants|||Number
165880|NCT00195715|Secondary|Percentage of Subjects Achieving Steroid-free Clinical Remission|Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, Subjects with steroid use at baseline of preceding study, Observed Cases||Percentage of participants|||Number
167274|NCT00168831|Secondary|Change From Baseline in Haemoglobin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
165884|NCT00195715|Primary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 156|Intent-to-treat, defined as all subjects who received at least 1 dose of study drug; Observed Cases||Percentage of participants|||Number
165885|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 108|Intent-to-treat, Observed Cases||Percentage of participants|||Number
165886|NCT00195715|Secondary|Percentage of Subjects Achieving Clinical Remission|Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.|Week 48|Intent-to-treat, Observed Cases||Percentage of participants|||Number
165887|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 520|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 520|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
165888|NCT00195702|Other Pre-specified|Change From Baseline in Modified Total Sharp X-ray Score at Week 416|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 416|Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
165889|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 520|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
165890|NCT00195702|Other Pre-specified|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 260|Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||units on a scale||Standard Deviation|Mean
165891|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||participants|||Number
165892|NCT00195702|Other Pre-specified|Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260|The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.|Week 260|Participants analyzed were intent-to-treat with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).||participants|||Number
166049|NCT00194025|Secondary|Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
165893|NCT00195702|Other Pre-specified|Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10|Patients were responders if they had: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Baseline through Week 520|Participants analyzed were intent-to-treat subjects with non-missing response. Analyses were performed using data as observed (no imputation).||participants|||Number
165894|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
165895|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
165896|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
165897|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).||participants|||Number
165898|NCT00195702|Other Pre-specified|Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 520|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (without imputation).||participants|||Number
165899|NCT00195702|Other Pre-specified|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.|Week 260|Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed as observed (without imputation).||Participants|||Number
165900|NCT00195702|Other Pre-specified|Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.||participants|||Number
165901|NCT00195702|Other Pre-specified|Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)|Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.|Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group|Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.||participants|||Number
165902|NCT00195702|Secondary|Estimated Yearly Progression of Rheumatoid Arthritis|Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline.||Units on a scale||Standard Deviation|Mean
165903|NCT00195702|Secondary|Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR70 response criteria for the first time at each time point is presented.||Participants|||Number
165904|NCT00195702|Secondary|Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR50 response criteria for the first time at each time point is presented.||Participants|||Number
165905|NCT00195702|Secondary|Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR20 response criteria for the first time at each time point is presented.||Participants|||Number
165906|NCT00195702|Secondary|Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment|Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Baseline through Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.||Participants|||Number
165907|NCT00195702|Secondary|Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were ACR20 responders at Week 24 were evaluated to determine whether the response was maintained. Observed data were analyzed.||Participants|||Number
165908|NCT00195702|Secondary|Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were responders at Week 12 or 24 were evaluated to determine whether the response was maintained. LOCF data analysis was used for missing values.||Participants|||Number
165909|NCT00195702|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Last observation carried forward (LOCF) data analysis was used for missing values.||Units on a scale||Standard Deviation|Mean
165948|NCT00195663|Secondary|Change From Baseline in the Mental Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
165910|NCT00195702|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24|Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. LOCF data analysis was used for missing values.||Units on a scale||Standard Deviation|Mean
165911|NCT00195702|Secondary|Change From Baseline in Modified Total Sharp X-ray Score at Week 24|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 52.||Units on a scale||Standard Deviation|Mean
165912|NCT00195702|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.||Participants|||Number
165913|NCT00195702|Primary|Change From Baseline in Modified Total Sharp X-ray Score at Week 52|Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.|Baseline and Week 52|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 24 or early termination.||Units on a scale||Standard Deviation|Mean
165914|NCT00195702|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24|Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.|Week 24|Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.||Participants|||Number
165915|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who did not relapse (did not have a PGA greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.||percentage of participants|||Number
165916|NCT00195676|Other Pre-specified|Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|Participants in the Period R mITT population who had relapsed (had a PGA of greater than or equal to 3) with adalimumab treatment withdrawal during Period W. Results were analyzed using non-responder imputation (NRI) for missing values.||percentage of participants|||Number
165917|NCT00195676|Other Pre-specified|Time to Relapse in Period W|Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe).|Period W|Participants in the Period W Modified Intent-to-Treat Population who had relapsed (defined by a PGA of greater than or equal to 3) during Period W and had at least one post-baseline PGA assessment in Period W.||days||95% Confidence Interval|Median
165940|NCT00195663|Secondary|Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase|ACR-N is a composite, continuous variable which measures the percentage of improvement from Baseline in individual participants based on the 7 core set variables of the ACR. ACR-N is defined as the smallest percent change from Baseline of 3 measures: tender joint counts (TJC), swollen joint counts (SJC), and the median percent improvement in the 5 remaining measures (Patient's Assessment of Pain, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Health Assessment Questionnaire - Disability Index [HAQ-DI], and C-Reactive Protein). A positive ACR-N value indicates improvement; a negative ACR-N value indicates worsening; ACR-N of 0 indicates no change.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.||percent change||Standard Deviation|Mean
165918|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 120|A subset of the the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
165919|NCT00195676|Other Pre-specified|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60|Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
165920|NCT00195676|Primary|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 16 of Period R|The Period R Modified Intent-to-Treat population included 178 participants who relapsed and 107 participants who did not relapse in Period W when therapy was withdrawn; all received Period R adalimumab 40 mg every other week (after an 80 mg initial dose). Results were analyzed using non-responder imputation (NRI) for missing values.||percentage of participants|||Number
165921|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 120|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
165922|NCT00195676|Other Pre-specified|Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60|The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.|Week 60|A subset of the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study. Results were analyzed using Last Observation Carried Forward (LOCF) imputation for missing values.||percentage of participants|||Number
165923|NCT00195663|Secondary|Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A decrease in the HAQ-DI score represents an improvement in physical function; a clinically significant improvement is defined as a decrease of least 0.22 from Baseline in the HAQ-DI score. The number of participants with improvement in HAQ-DI of at least 0.22 and 0.5 units from Baseline is reported.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing HAQ-DI scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."||participants|||Number
165924|NCT00195663|Secondary|Number of Participants With a Major Clinical Response Over 10 Years by Adalimumab Exposure|"A major clinical response was defined as maintenance of an ACR70 response for at least a 6-month continuous period at any time during the study following the first dose of adalimumab. A participant was a responder if the following criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein)."|From the first dose of adalimumab (at Week 1 or Week 106 for patients initially randomized to methotrexate in the DB phase) to Year 10|ITT Analysis Set for participants with non-missing ACR data.||participants|||Number
165925|NCT00195663|Secondary|Composite Score of ACR50 Plus No Change in Modified Total Sharp Score||Year 10|This outcome measure was not analyzed due to a protocol amendment.|||||
166051|NCT00194025|Secondary|Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)|The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
165926|NCT00195663|Secondary|Number of Participants With No Radiographic Progression Over 10 Years|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement. The number of participants with change from Baseline ≤ 0.5 and ≤ 0 is reported as a measure of no disease progression.|Baseline (prior to first study drug treatment) and Years 2 and 10.|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."||participants|||Number
165927|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) Over 10 Years|The modified TSS (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (prior to first study drug treatment) and Years 2 and 10|"ITT Analysis Set, with available data. N indicates patients with non-missing radiographic data at each time point."||units on a scale||Standard Deviation|Mean
165928|NCT00195663|Secondary|Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|After 1, 2, 5, and 10 years of adalimumab exposure|"ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing DAS28 scores at any post-baseline time point; N indicates patients with non-missing data at each specified time point."||participants|||Number
165929|NCT00195663|Secondary|Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at Baseline and the specified time point."||units on a scale||Standard Deviation|Mean
165930|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.|"ITT Analysis Set, with available data. N indicates patients with non-missing data at each time point."||units on a scale||Standard Deviation|Mean
165931|NCT00195663|Secondary|Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available data. N indicates patients with non-missing data at each time point."||participants|||Number
165932|NCT00195663|Secondary|Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"ITT Analysis Set with available ACR data. N indicates patients with non-missing data at each time point."||participants|||Number
165933|NCT00195663|Secondary|Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Baseline is the last value prior to the first dose of adalimumab. For participants randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase."|Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.|"Intent-to-treat (ITT) Analysis Set (all patients who received at least 1 dose of adalimumab during the study, including patients who received their first dose during the DB phase and those who received MTX during the DB phase and adalimumab in the OL phase) with available ACR data. N indicates patients with non-missing data at each time point."||participants|||Number
165934|NCT00195663|Secondary|Number of Participants With Non-Involved Joints at Baseline and No Newly Involved Joints at Weeks 52 and 104|"Number of participants with non-involved joints at Baseline and no newly involved joints at Weeks 52 and 104, where involved joints or no newly involved joints are defined as modified Total Sharp Score (mTSS) = 0.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease])."|Baseline and Weeks 52 and 104|Full analysis set participants with non-involved joints at Baseline and non-missing data.||participants|||Number
165935|NCT00195663|Secondary|Number of Participants With No Erosions at Baseline and No New Erosions at Weeks 52 and 104|"The number of participants with no erosions at Baseline and no erosions at Weeks 52 and 104, where no erosions and no new erosions are defined as an erosion score = 0.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21–40% joint involvement; 3 = 3 separate quadrants with erosion or 41–60% joint involvement; 4 = all 4 quadrants with erosion or 61–80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 230 (worst)."|Baseline and Weeks 52 and 104|Full analysis set participants with no erosions at Baseline and non-missing data.||participants|||Number
165936|NCT00195663|Secondary|Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase|"The number of participants with no worsening in the modified Total Sharp Score (mTSS) and in erosion and joint space narrowing (JSN) scores, where no worsening is defined as a change from Baseline of ≤ 0 in mTSS, erosion score and JSN score, at Weeks 52 and 104.~Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement."|Baseline and Weeks 52 and 104|Full analysis set. Participants with missing data or who withdrew early were considered non-responders.||participants|||Number
165937|NCT00195663|Secondary|Change From Baseline in Joint Space Narrowing Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (16 joints) and each forefoot (5 joints) on a 5-point scale (0 = no narrowing; 1 = up to 25% narrowing; 2 = 26–65% narrowing; 3 = 66–99% narrowing; and 4 = complete narrowing). Scores were summed to calculate the total score ranging from 0 (no narrowing) to 168 (maximum narrowing). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.||units on a scale||Standard Deviation|Mean
165938|NCT00195663|Secondary|Change From Baseline in Joint Erosion Score During the Double-blind Treatment Period|Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21–40% joint involvement; 3 = 3 separate quadrants with erosion or 41–60% joint involvement; 4 = all 4 quadrants with erosion or 61–80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion)to 230 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion.|Baseline and Weeks 52 and 104|Full analysis set. Missing values were imputed.||units on a scale||Standard Deviation|Mean
165939|NCT00195663|Secondary|Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase|"The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:~28 tender joint counts,~28 swollen joint counts,~C-reactive protein, and~Patient's global assessment of disease activity.~Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
166050|NCT00194025|Secondary|Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)|The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|The number of participants for analysis was based on available data. Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
165941|NCT00195663|Secondary|Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component and items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Weeks 26 and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
165942|NCT00195663|Secondary|Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase|"The HUI 2/3 is an assessment of various aspects of participants’ health and ability to perform various tasks on a day-to-day basis, including reading, seeing, hearing, speaking, general outlook on life, pain/discomfort, ability to walk, use of hands, memory, ability to think/solve, and ability to perform basic activities such as eating, bathing, and dressing. The HUI 2/3 is a combined 15-item questionnaire based on a recall period of the previous 4 weeks. HUI-2 and HUI-3 scores are calculated independently. The HUI-2 score includes 6 attributes: Sensation, Mobility, Emotion, Cognition, Self-Care, and Pain. The HUI-3 score is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition, and Pain.~The range of each score is from 0 (dead) to 1 (perfect health). An increase from Baseline indicates improvement."|Baseline and Weeks 26, 52, and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
165943|NCT00195663|Secondary|Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Missing values were considered to be < 0.3.||participants|||Number
165944|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Weeks 12, 26, 76, and 104|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
165945|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR70 or who withdrew early were considered non-responders.||participants|||Number
165946|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26, 52, 76, and 104|Full analysis set. Participants with insufficient data to calculate ACR20 or who withdrew early were considered non-responders.||participants|||Number
165947|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Weeks 26 and 76|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Weeks 26 and 76|Full analysis set. Participants with insufficient data to calculate ACR50 or who withdrew early were considered non-responders.||participants|||Number
165976|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Handling of ReFacto|Subjective assessment by the participant on handling (preparation and administration) of ReFacto. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
165949|NCT00195663|Secondary|Number of Participants With Major Clinical Response After 104 Weeks of Treatment|"Major clinical response was defined as an American College of Rheumatology 70% (ACR70) response for any six continuous months, over 104 weeks of treatment. A participant was a responder if the following criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were non-responders."|Any 6 continuous months from Baseline to Week 104|Full analysis set.||participants|||Number
165950|NCT00195663|Secondary|Change From Baseline in the Physical Component of the Short Form-36 Health Status Survey (SF-36) at Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.|Baseline and Week 52|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
165951|NCT00195663|Secondary|Number of Participants Who Achieved Clinical Remission, Defined as a Disease Activity 28 (DAS28) Score < 2.6 at Week 52|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 52|Full analysis set. Participants with insufficient data to calculate DAS28 at Week 52 or who withdrew early were considered non-responders.||participants|||Number
165952|NCT00195663|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 104|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 104 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 104|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.||units on a scale||Standard Deviation|Mean
165953|NCT00195663|Secondary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 104|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-Reactive Protein).~Participants withdrawing early were considered non-responders."|Baseline and Week 104|Full analysis set. Participants with insufficient data to calculate ACR50 at Week 104 or who withdrew early were considered non-responders.||participants|||Number
165954|NCT00195663|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 52|Full analysis set with available data.||units on a scale||Standard Deviation|Mean
165955|NCT00195663|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 52 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 52|Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.||units on a scale||Standard Deviation|Mean
165956|NCT00195663|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~Acute phase reactant value (C-Reactive Protein).~Participants who withdrew early were considered non-responders."|Baseline and 52 Weeks|The Full Analysis Set consisted of all patients who were randomized and who received at least one dose of double-blinded study medication. Participants with insufficient data to calculate ACR50 at Week 52 or who withdrew early were considered non-responders.||participants|||Number
165957|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260|All participants who received at least 1 dose of open-label adalimumab (Full Analysis Set) in the continuation study and had a Week 260 visit. Analysis used observed data (no imputation).||units on a scale||Standard Deviation|Mean
165958|NCT00195650|Primary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520|The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.|Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||units on a scale||Standard Deviation|Mean
165959|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
165960|NCT00195650|Primary|Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520|Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
165961|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
165962|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520|ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
165963|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
165964|NCT00195650|Secondary|Reported Adverse Events|Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.|Duration of study (up to 520 weeks [10 years])|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set).||participants|||Number
167275|NCT00168831|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)||Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Percentage of erythrocytes||Standard Deviation|Mean
165965|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520|ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
165966|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 260|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).||participants|||Number
165967|NCT00195650|Primary|Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520|ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.|Week 520|All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).||participants|||Number
165968|NCT00195507|Secondary|Number of Patients With Survey Response of “Somewhat Satisfied” or Better|Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation.||participants|||Number
165969|NCT00195507|Secondary|Time to Achieve a Physician Global Assessment of Psoriasis Score of “Clear” or “Almost Clear”|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.|54 weeks|The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug, had at least 1 post-baseline evaluation and who achieved a PGA status of 0 or 1 by the last visit (Observed cases).||days||95% Confidence Interval|Median
165970|NCT00195507|Secondary|Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline|Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).||percentage improvement|||Number
165971|NCT00195507|Primary|Physician Global Assessment of Psoriasis (PGA) Score – Mean Value Over 54 Weeks|Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).|54 weeks|The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).||units on scale||Standard Deviation|Mean
165972|NCT00195494|Secondary|Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death|Safety report for entire trial where participants reported a serious adverse event that led to death.|12 and 24 months|The analysis population is the modified intent to treat for year 1 (542 overall baseline participants) and year 2 (411 overall baseline participants).||participants|||Number
165973|NCT00195494|Primary|Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.|The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.||participants|||Number
165974|NCT00195494|Primary|The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.|Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.|12 months|The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.||participants|||Number
165975|NCT00195442|Secondary|Number of Participants for Days of Sick Leave Per Month|Days of sick leave (missing work or school) per month categorized as No days of absence, Number of days of absence, Long-term inability to work or study, Not employed or at school, or No specification.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
166044|NCT00194077|Primary|Time in Weeks to Discontinuation|Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.|up to 72 weeks|||time in weeks to discontinuation||95% Confidence Interval|Mean
165977|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Handling of ReFacto|Subjective assessment by the physician to evaluate the participants’ handling (preparation and administration) of ReFacto. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
165978|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Tolerance|Subjective assessment by the participant to evaluate tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
165979|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Tolerance|Subjective assessment by the physician to evaluate the participants’ tolerance of treatment with ReFacto (i.e., dose, administration method, or adverse effects). Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
165980|NCT00195442|Secondary|Number of Participants for Patients' Assessment of Efficacy|Subjective assessment by the participant to evaluate control of bleeding. Patient rated assessment could be categorized as Very good, Good, Moderate, Poor, or No specification; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
165981|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Efficacy|Subjective assessment by the physician to evaluate control of bleeding. Physician rated assessment could be categorized as Very good, Good, Moderate, or Poor; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
165982|NCT00195442|Secondary|Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success|Subjective assessment by the physician to evaluate treatment success (i.e., control of bleeding, Factor VIII consumption, treatment efficacy and tolerance, handling of preparation, and days missing from work or school). Physician rated assessment could be categorized as Very satisfied, Satisfied, Unsatisfied, or Very unsatisfied; no criteria was pre-specified for the assessment categories in this observational study.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit. N=participants with evaluable data; last measurement available.||participants|||Number
165983|NCT00195442|Secondary|Mean Annual ReFacto Consumption Per Patient Year|ReFacto administered as International Units (IU) according to the physician's decision following the drug's summary of product characteristics (SPC) and according to usual care principles.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||International units per year||Standard Deviation|Mean
165984|NCT00195442|Secondary|Number of Participants With de Novo Inhibitor Formation|The applied criteria of clinical relevance for de novo inhibitor formation was defined as normal Factor VIII dosage was ineffective to control a bleeding, control of bleeding episodes required increasing Factor VIII dosage, change of concentrate type (administration of activated Prothrombin-Complex Concentrate [aPCC] or recombinant Factor VII [rFVII ]) was needed to stop a bleeding, or change of therapy strategy (intensive prophylaxis or Immune Tolerance Induction [ITI]) was required.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit.||participants|||Number
165985|NCT00195442|Secondary|Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any undesired side effect which occurred in a participant undergoing study treatment independent of whether a correlation with study treatment was suspected or not. SAEs are undesired events which were lethal or life-threatening, made hospitalization or extension of hospital stay necessary, lead to permanent damage with handicap (inability to work), as well as congenital anomalies, malignant disease, or overdosing. Also presence of inhibitors, thrombotic events, erythrocyte agglutination, allergic reactions, less than therapeutic effect, and inhibitor development were considered SAEs.|Baseline up to a mean duration of 54 months|Safety population includes all subjects with a baseline visit; (n)=number of participants with events.||events|||Number
165986|NCT00195442|Primary|Mean Number of Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||days per year||Standard Deviation|Mean
165987|NCT00195442|Primary|Mean Number of Bleeding-related Exposure Days Per Patient Year|Exposure days are the number of days of treatment with ReFacto.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||days per year||Standard Deviation|Mean
165988|NCT00195442|Primary|Mean Number of Bleeding Episodes Per Patient Year|Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study.|Baseline up to a mean duration of 54 months|Total population for efficacy analysis included all participants with submitted diary cards and severe haemophilia.||episodes per year||Standard Deviation|Mean
166045|NCT00194025|Secondary|Tolerability as Measured by Mean Serum Level at Study Endpoint||Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||ug/mL||Standard Deviation|Mean
166046|NCT00194025|Secondary|Tolerability as Assessed by Weight Change||Baseline to 12 weeks|All available data was used implementing LOCF.||kilograms||Standard Deviation|Mean
165989|NCT00195429|Secondary|Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|12 months|The population that was used for this analysis was patients who completed 12 months.||ml/min||Standard Deviation|Mean
165990|NCT00195429|Primary|Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.|Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).|12 months|The population that was used for this analysis was the transplantation recipient population, which included all randomized patients.||participants|||Number
165991|NCT00195403|Secondary|Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9|Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Month 3, 9|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. 'N' (number of participants analyzed) = participants who were evaluable for this measure. Data for Month 9 was not analyzed because there were not enough participants for analysis.||joints||Standard Deviation|Mean
165992|NCT00195403|Primary|Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3|PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.|Baseline, Month 3|Efficacy population included all participants who received >=1 dose of study medication and had the efficacy assessment within 14 days after the final administration.||cm||Standard Deviation|Mean
165993|NCT00195403|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.|Baseline up to Day 832|Safety population included all participants who received >= 1 dose of study medication and had the safety assessment through appropriate follow-up.||participants|||Number
165994|NCT00195351|Secondary|Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.|Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
165995|NCT00195351|Secondary|Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.||participants|||Number
165996|NCT00195351|Primary|Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.|The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.|10-21 days after the last dose of test article|All patients who received ≥1 dose of study drug, who had clinical evidence of complicated intra-abdominal infection, met all inclusion and exclusion criteria, and completed TOC assessment within 8-44 days after last dose of study drug. Patients with an indeterminate assessment were excluded.||participants|||Number
165997|NCT00195338|Secondary|Mean Dose of Concomitant Methotrexate (MTX) and Steroids||Baseline up to Month 66|Data was not analyzed due to low number of participants.||milligram (mg)||Standard Deviation|Mean
165998|NCT00195338|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty = 0), 'adequate' (some difficulty = 1), 'limited' (much difficulty = 2), and 'unable to do' (= 3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total possible score ranged from 0 (no difficulty) to 60 (unable to do).|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.||units on a scale||Standard Deviation|Mean
166047|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)|The best and worst possible overall scores are 40 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
165999|NCT00195338|Secondary|Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66|Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.|Baseline, Months 6, 12, 18, 30, 42, 54 and 66|FAS included all recruited participants who were either initiated or were already receiving etanercept. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.||joints||Standard Deviation|Mean
166000|NCT00195338|Secondary|Percentage of Participants With Completion of Study Treatment||Month 12 through Month 72|FAS included all recruited participants who were either initiated or were already receiving etanercept.||percentage of participants|||Number
166001|NCT00195338|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 66|Full analysis set (FAS) included all recruited participants who were either initiated or were already receiving etanercept.||percentage of participants|||Number
166002|NCT00195273|Secondary|Mean Creatinine Clearance Rate - 3 Months|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|3 months|All patients who completed 3 months of study drug.||ml/min||Standard Deviation|Mean
166003|NCT00195273|Secondary|Patient and Graft Survival|Graft survival is measured by graft loss which is defined as removal of the transplant.|12 months|All patients who received at least one dose of study drug.||patients|||Number
166004|NCT00195273|Secondary|Number of Patients With Acute Rejection|The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.|3 and 12 months|All patients who received at least one dose of study drug.||patients|||Number
166005|NCT00195273|Primary|Mean Creatinine Clearance Rate|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.|12 months|All patients who completed 12 months of study drug.||ml/min||Standard Deviation|Mean
166006|NCT00195260|Other Pre-specified|Gene Expression at Baseline|Gene expression profile was evaluated by measuring transcript levels of messenger RNA (mRNA) in peripheral blood samples. Expression profiling of mRNA: done to measure the expressed genome of mRNA transcripts or done in a gene-specific targeted manner.|Baseline|Data was not analyzed as the analysis was cancelled due to lack of samples provided from sites.|||||
166007|NCT00195260|Secondary|Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Steady state concentration was achieved at Day 15.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||ng*hour/mL||Standard Deviation|Mean
166008|NCT00195260|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||hours||Standard Deviation|Mean
166009|NCT00195260|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||hours||Full Range|Median
166010|NCT00195260|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14|Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
166011|NCT00195260|Secondary|Progression Free Survival (PFS) in Part 2|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD, or from death CRFs).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||weeks||95% Confidence Interval|Median
166048|NCT00194025|Secondary|Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)|The best and worst possible overall scores are 0 and 28 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
166012|NCT00195260|Secondary|Overall Survival (OS) in Part 2|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from death case report forms (CRFs) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||weeks||95% Confidence Interval|Median
166013|NCT00195260|Secondary|Number of Participants With Change From Baseline in Opthalmologic Examination|Ophthalmologic evaluation included visual acuity, funduscopic examination, and any clinically-significant abnormality.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
166014|NCT00195260|Secondary|Number of Participants With Change From Baseline in Physical Examination|Physical examinations included body weight, height and vital signs and only finding that exceeded the criterion for PCS was weight. Criteria for weight was: an increase or decrease of >=10% from baseline.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure for each group respectively.||participants|||Number
166015|NCT00195260|Secondary|Change From Baseline in Karnofsky Performance Score|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (complete healthy status). Higher score means higher ability to perform daily tasks.|Baseline up to end of treatment (Week 95)|Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.|||||
166016|NCT00195260|Secondary|Concomitant Medications Used for Management of Adverse Events (AEs)|Number of participants taking any non-study medications which were administered from Day 1 up to end of treatment (Week 95) as a management of an AE was to be reported.|Day 1 up to end of treatment (Week 95)|Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.|||||
166017|NCT00195260|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG) and Chest X-ray|Number of participants with PCS ECG findings is reported on-therapy (OT) and at final visit (FV). Criteria for PCS ECG findings: heart rate (HR) =<45 beats/minute (bpm) and decrease (Dec) >15/>=120 bpm and decrease of >15 bpm; PR interval (Int) >=220 millisecond (msec), increase (Inc) >=20 msec, QRS Int >=120 msec, corrected QT (QTc) and QTc using fridericia formula(QTcF) Int >500 msec, increase >60 msec; no sinus rhythm; overall ECG abnormal. Participants with at least 1 measurement exceeding the criteria for PCS are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure and 'n' represents participants evaluable under each category for each group respectively.||participants|||Number
166018|NCT00195260|Secondary|Number of Participants With Change From Baseline in Laboratory Test Results|Criteria for potentially clinically significant (PCS) laboratory values: albumin <20, hemoglobin <80 gram/liter(g/L); alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); bilirubin total, creatinine>3*ULN micromole/L; calcium <1.75 and >3.1,potassium <3 and >6, sodium <130, glucose <2.2,phosphorous <0.6 millimole/L; international normalized ratio >2*ULN, partial thromboplastin time, prothrombin time >2*ULN seconds; platelet count <50*10^9/L. Participants meeting at least 1 PCS criteria are reported.|Baseline up to end of treatment (Week 95)|Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy laboratory assessment) for this measure for each group respectively.||participants|||Number
166019|NCT00195260|Secondary|Maximum Tolerated Dose (MTD) for Prolonged Use|MTD for prolonged use was the highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1) and was selected as recommended dose in Phase 2, due to substantial number of Grade 2 gastrointestinal toxicities observed in the MTD lead-in cohort (500 mg).|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.||mg|||Number
166020|NCT00195260|Primary|Maximum Tolerated Dose (MTD) in Part 1|MTD: highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Day 1 up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.||mg|||Number
166021|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 2|BOR: investigator assessment by modified RECIST, recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 2 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||participants|||Number
167481|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin/Osteocalcin (UCOC/OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of UCOC/OC||Inter-Quartile Range|Median
166022|NCT00195260|Primary|Number of Participants With Best Overall Response (BOR) in Part 1|BOR:investigator assessment by modified Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response:disappearance of all lesions. Partial Response (PR):>=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Part 1 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose|Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.||participants|||Number
166023|NCT00195260|Primary|Duration of Most Frequently Observed Adverse Events (AEs)|The most frequently observed treatment-emergent AEs were gastrointestinal disorders which included diarrhea, nausea and vomiting. Duration of AE per event is calculated as AE stop date minus AE start date plus 1.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.||days||Full Range|Median
166024|NCT00195260|Primary|Number of Participants With Adverse Events (AEs) by Seriousness|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 30 days after last dose|Safety population included all participants who had taken at least 1 dose of study medication.||participants|||Number
166025|NCT00195260|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Part 1|DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to less than or equal to [=<] grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.|Part 1 Baseline up to Day 28|Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.||participants|||Number
166026|NCT00194896|Secondary|Patients Positive for T Cell Responses to Islet Proteins at 36 Months.|Number of participants positive for T cell reactivity to islet proteins at 36 months.|36 months|||participants|||Number
166027|NCT00194896|Primary|Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.|Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.|36 months|Analysis per protocol||ng per ml||Standard Deviation|Mean
166028|NCT00194675|Secondary|Serum Hormone Levels: Total Testosterone, Free Testosterone, and Dihydrotestosterone(DHT), Dehydroepiandrosterone(DHEA), and Androstenedione.||Baseline, 3-months, 6-months|per protocol||ng/ dL||Standard Deviation|Mean
166029|NCT00194675|Secondary|Signs and Symptoms Benign Prostatic Hyperplasia (BPH): Post-voiding Residual (PVR) Urinary Volume||Baseline, 3-months, 6-months|||cc||Standard Deviation|Mean
166030|NCT00194675|Secondary|Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men (Uroflow)||Baseline, 3-months, 6-months|per protocol||cc/sec||Standard Deviation|Mean
166031|NCT00194675|Secondary|The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)|International Prostate Symptom Score to assess lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Minimum score = 0, maximum score = 35; mildly symptomatic score = 0-7; moderately symptomatic score = 8-19; severely symptomatic score = 20-35; no subscales.|Baseline, Month 3, Month 6|per protocol||score||Standard Deviation|Mean
166032|NCT00194675|Secondary|Androgen-responsive Gene Expression and Proliferation in the Stromal and Epithelial Compartments of the Prostate||6-months||||||
166033|NCT00194675|Secondary|Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)||Baseline, Month 6|per protocol||ng/ ml||Standard Deviation|Mean
166034|NCT00194675|Primary|Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.||Baseline, Month 6|per protocol||cubic centimeters||Standard Deviation|Mean
166035|NCT00194610|Primary|Chronic Prostatitis Symptom Index (CPSI-F)|CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.|3 months|Total number of subjects was based on clinical volume, and subjects were randomized into each of two arms.||Total CPSI-F||Standard Deviation|Mean
166036|NCT00194532|Secondary|Microbiologic Cure|Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up|1-15 days post therapy|Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up.||participants|||Number
166037|NCT00194532|Primary|Clinical Cure|Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin|28-30 days post therapy|modified ITT||participants|||Number
166038|NCT00194129|Secondary|Change in Rate of Cocaine Use Disorders After Open-label Treatment With Lithium and Divalproex||Baseline to Month 6||||||
166039|NCT00194129|Secondary|Change in Rate of Cannabis Use Disorders After Open-label Treatment With Lithium and Divalproex||Baseline to Month 6||||||
166040|NCT00194129|Secondary|Change in Rate of Alcohol Use Disorders After Open-label Treatment With Lithium and Divalproex||Baseline to Month 6||||||
166041|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Depressive Episode||Up to 6 months||||||
166042|NCT00194129|Secondary|Time to Treatment for Emerging Symptoms of a Manic/Hypomanic/Mixed Episode||Up to 6 months||||||
166043|NCT00194129|Primary|Time to Treatment for Emerging Symptoms of a Mood Relapse||Up to 6 months|||weeks||95% Confidence Interval|Median
166052|NCT00194025|Secondary|Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)|The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
166053|NCT00194025|Secondary|Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)|The best and worst possible overall scores are 31 and 0 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
166054|NCT00194025|Primary|Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)|The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.|Baseline to 12 weeks|Last Observation Carried Forward (LOCF) was used as the imputation technique.||scores on a scale||Standard Deviation|Mean
166055|NCT00194012|Primary|Youth Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient’s subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.|12 weeks|||Scores on a scale||95% Confidence Interval|Mean
166056|NCT00193609|Secondary|Overall Survival|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|18 months|||months||95% Confidence Interval|Median
166057|NCT00193609|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|18 months|||months||95% Confidence Interval|Median
166058|NCT00193596|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|12 months|||months||95% Confidence Interval|Median
166059|NCT00193596|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|24 months|||months||95% Confidence Interval|Median
166060|NCT00193492|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death or Disease Progression from NHL. Progression is defined using International Workshop Response Criteria for Non-Hodgkin’s Lymphoma as - enlargment of liver/spleen, new sites, new or increased malignancy in lymph nodes, new or increased lymph node masses or reappearance of disease in bone marrow.|18 months|||months||95% Confidence Interval|Median
166061|NCT00193492|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|||percentage of participants||95% Confidence Interval|Number
166062|NCT00193479|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months|||percentage of patients|||Number
166063|NCT00193453|Secondary|Response Duration|The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.||Months||95% Confidence Interval|Median
166064|NCT00193453|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.|18 months|All patients were assessed for progression-free survival.||Months||95% Confidence Interval|Median
166065|NCT00193453|Primary|Overall Clinical Response Rate|Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.|18 months|Patients with at least one restaging were assessed for overall clinical response. Patients who died prior to the first restaging or were not assessed due to physician/patient discretion were not included in the analysis.||Percentage of participants||95% Confidence Interval|Number
166066|NCT00193427|Secondary|Overall Survival (OS)|Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.|18 months|All patients were assessed for overall survival after a median follow-up of 19 months.||Months||95% Confidence Interval|Median
166067|NCT00193427|Secondary|Overall Response Rate (ORR)|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|Patients who were assessable after completion of 9 weeks of treatment were evaluated and assigned a response category.||Percent of patients with CR or PR|||Number
166068|NCT00193427|Secondary|Progression Free Survival (PFS)|Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.|19 months|All patients were assessed for progression free survival after a median follow up of 19 months.||Months||95% Confidence Interval|Median
175711|NCT00073073|Secondary|Effect of This Drug on Bone Mineral Density||1 year|||percent change from baseline||95% Confidence Interval|Mean
166069|NCT00193427|Primary|Pathologic Complete Response Rate|A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.|18 months|All patients who underwent a thoracotomy were assigned a pathologic response category.||Percent of participants with pCR|||Number
166070|NCT00193414|Secondary|Overall Survival (OS)|OS was measured from the date of study entry until the date of death.|18 months|All patients were assessed for OS.||Months||95% Confidence Interval|Median
166071|NCT00193414|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months|All patients were assessed for PFS.||Months||95% Confidence Interval|Median
166072|NCT00193414|Primary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 months|All patients were assessed for response.||Percentage of participants with CR/PR||95% Confidence Interval|Number
166073|NCT00193375|Primary|Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)|Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.|18 months|Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities.||Grade 3/4 Toxicity Events|||Number
166074|NCT00193375|Secondary|Overall Response Rate|Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.|18 month|All patients were evaluated for response by RECIST v. 1 criteria. All patients with major responses had confirmation of response on repeat scans by the same technique(s) 4 weeks (or longer) later.||percentage of participants||95% Confidence Interval|Number
166075|NCT00193375|Secondary|2-Year Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.|24 months|All patients were assessed for progression free survival.||percentage of participants|||Number
166076|NCT00193258|Primary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||24 months|All patients enrolled in the study||months||95% Confidence Interval|Median
166077|NCT00193258|Primary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease||18 months|All patients enrolled in the trial||months||95% Confidence Interval|Median
166078|NCT00193258|Primary|Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Eighty-seven of 94 patients (93%) received ≥ 2 months of treatment and were fully evaluable for response. Seven patients discontinued treatment during the first 8 weeks. One of these 7 patients had evidence of rapid tumor progression, whereas the remaining 6 patients discontinued treatment because of toxicity or for personal reasons.||percentage of participants||95% Confidence Interval|Number
166079|NCT00193219|Secondary|Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab||18 months||||||
166080|NCT00193219|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Measured from the date of first treatment until the date of death from any cause|36 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.||months||95% Confidence Interval|Median
166081|NCT00193219|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.||months||95% Confidence Interval|Median
166082|NCT00193219|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|This study was originally designed as a randomized study with patients receiving FOLFOX and bevacizumab with or without cetuximab. Following an amendment, all patients received cetuximab, FOLFOX and bevacizumab. The 5 patients randomized prior to the amendment that did not receive cetuximab are excluded from the analysis.||percentage of patients||95% Confidence Interval|Number
166083|NCT00193206|Secondary|Rates of Breast Preservation||18 months||||||
166084|NCT00193206|Secondary|Time to Disease Progression||18 months||||||
166085|NCT00193206|Secondary|Clinical Response Rates||18 months||||||
166086|NCT00193206|Primary|Pathologic Complete Response||18 months|||participants|||Number
166087|NCT00193180|Secondary|Overall Survival (OS)|Defined as the time from first protocol treatment to date of death due to any cause.|18 months|||months||95% Confidence Interval|Median
166088|NCT00193180|Secondary|Progression Free Survival (PFS)|PFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|18 months|||Months||95% Confidence Interval|Median
166089|NCT00193180|Primary|Overall Response Rate (ORR)|Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.|18 months|||percentage of participants||95% Confidence Interval|Number
166090|NCT00193128|Secondary|Overall Survival (OS)|Length of time, in months, that patients were alive from their first date of protocol treatment until death.|36 months||||||
166091|NCT00193128|Secondary|Disease-Free Survival (DFS)|Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.|18 months||||||
166092|NCT00193128|Primary|Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery|The absence of any residual tumor cells in a histologic evaluation of a tumor specimen is defined as a complete pathologic response|18 months|Analysis was conducted on the 49 patients in Cohort 2 who received triplet chemotherapy||percentage of participants|||Number
166093|NCT00193063|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|24 months|||months||95% Confidence Interval|Median
166094|NCT00193063|Secondary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|21 Months|||months||95% Confidence Interval|Median
166095|NCT00193063|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 Months|||percentage of participants||95% Confidence Interval|Number
166096|NCT00193050|Secondary|Overall Survival (OS)||48 months||||||
166097|NCT00193050|Secondary|Time to Treatment Failure (TTF)||69 months||||||
166098|NCT00193050|Primary|Pathologic Complete Response (pCR)||18 Months|||percentage of participants||95% Confidence Interval|Number
166099|NCT00193037|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.|PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.|18 Months|||months||95% Confidence Interval|Median
166100|NCT00193037|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.|18 Months|Patients who were removed from treatment before evaluation were not included in analysis||percentage of patients||95% Confidence Interval|Number
166101|NCT00192296|Secondary|Terminal Phase Elimination Rate (Vz)|Vz of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Liters||Geometric Coefficient of Variation|Geometric Mean
166102|NCT00192296|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Hours||Geometric Coefficient of Variation|Geometric Mean
166103|NCT00192296|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Milliter per day||Geometric Coefficient of Variation|Geometric Mean
166104|NCT00192296|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Percentage of Projected AUC||Geometric Coefficient of Variation|Geometric Mean
166105|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]|AUC(0-infinity) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Microgram times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
166106|NCT00192296|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
166107|NCT00192296|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
166108|NCT00192296|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528||Hours||Full Range|Median
166109|NCT00192296|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants who had ADA detected at each time point|Days 14, 28, 42, and 84|All subjects who received MEDI-528||Participants|||Number
166110|NCT00192296|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528||Participants|||Number
166111|NCT00192296|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)|Days 0, 7, 14, 21, and 28|All subjects who received MEDI-528||Participants|||Number
166112|NCT00192296|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528||Participants|||Number
166113|NCT00192647|Secondary|Change From Baseline in Log10 HCV RNA Values|The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.|Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)|ITT analysis population; Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.||Log 10 IU/mL||Standard Deviation|Mean
166114|NCT00192647|Secondary|Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response|The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.|Weeks 4, 12, and 72|ITT analysis population; participants who did not have an HCV RNA measurement at Week 4 or 12 and at Week 72 were excluded from the analysis. Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.||percentage of participants|||Number
166115|NCT00192647|Secondary|Percentage of Participants With Relapse of End-of-treatment Virological Response|Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.|Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)|ITT analysis population. Here, number of participants analyzed signifies participants who had end of treatment virologic response and had HCV RNA measurement available during follow-up.||percentage of participants|||Number
166116|NCT00192647|Secondary|Percentage of Participants With Virological Responses Over Time|Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.|Weeks 4, 8, 12, and 24|ITT analysis population||percentage of participants|||Number
166117|NCT00192647|Secondary|Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period|Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.|Weeks 48|ITT analysis population||percentage of participants|||Number
166118|NCT00192647|Primary|Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period|Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.|Week 72|ITT analysis population||percentage of participants|||Number
166119|NCT00192075|Other Pre-specified|Duration of Response - A+FOLFOX4 - Avastin Subgroup|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup.||months||95% Confidence Interval|Median
166120|NCT00192075|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
166121|NCT00192075|Other Pre-specified|Toxicity - Avastin Subgroup|Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events|every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.||participants|||Number
166122|NCT00192075|Other Pre-specified|Survival at 12 Months and 24 Months - Avastin Subgroup|Percentage of participants who were alive at 12 months and 24 months.|randomization to the date of death from any cause (up to 24 months)|The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.||percentage of participants alive||95% Confidence Interval|Number
166806|NCT00177970|Secondary|2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea|The quantity of anti-C. difficile antibodies with improve in relationship with recovery|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166123|NCT00192075|Other Pre-specified|Progression-Free Survival - Avastin Subgroup|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored.||months||95% Confidence Interval|Median
166124|NCT00192075|Other Pre-specified|Time to Progressive Disease - Avastin Subgroup|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored.||months||95% Confidence Interval|Median
166125|NCT00192075|Other Pre-specified|Tumor Response - Avastin Subgroup|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.||participants|||Number
166126|NCT00192075|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
166127|NCT00192075|Secondary|Progression-Free Survival|Defined as the time from randomization to the first observation of disease progression, or death due to any cause.|randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
166128|NCT00192075|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored.||months||95% Confidence Interval|Median
166129|NCT00192075|Primary|Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)|Intent-to-Treat Population||participants|||Number
166130|NCT00192036|Secondary|Safety of Chemo-radiotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy|All enrolled participants receiving chemo-radiotherapy (Cycle 4).||participants|||Number
166131|NCT00192036|Secondary|Safety of Induction Chemotherapy|A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.|every cycle (21 days) for 3 cycles (up to 10 weeks)|All enrolled participants.||participants|||Number
166132|NCT00192036|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)|All enrolled participants.||months||Full Range|Median
166133|NCT00192036|Secondary|Time to Progressive Disease|Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.|Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);|All enrolled participants.||months||Full Range|Median
166134|NCT00192036|Primary|Tumor Response at End of Treatment|Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)|All enrolled participants.||participants|||Number
166135|NCT00192023|Other Pre-specified|Open-Label Phase Nonserious Adverse Events|Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.||participants|||Number
166136|NCT00192023|Other Pre-specified|Open-Label Phase Serious Adverse Events|Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.|Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval|Number of patients who entered this optional open-label phase. All of the patients were dispensed drug.||participants|||Number
166137|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores|A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||units on a scale||Standard Deviation|Mean
166138|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(score-4.2382)*10/0.32835] + 50. Higher scores mean improvement.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||standard deviation units||Standard Deviation|Mean
166139|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||units on a scale||Standard Deviation|Mean
166140|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised|Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
166141|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score|The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints.||units on a scale||Standard Deviation|Mean
166142|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale|Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
166143|NCT00192023|Secondary|Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
166144|NCT00192023|Primary|Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale|Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.|Visit 8 (baseline) and Visit 14 (8 weeks)|Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied.||units on a scale||Standard Deviation|Mean
166145|NCT00191984|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||days||95% Confidence Interval|Median
166146|NCT00191984|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|baseline to stopping treatment (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||days||95% Confidence Interval|Median
166147|NCT00191984|Secondary|Progression-Free Survival (PFS)|Defined as the time from study enrollment to the first date of disease progression or death as a result of any cause. PFS was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed.|baseline to measured progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||days||95% Confidence Interval|Median
166148|NCT00191984|Secondary|Duration of Response|"The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.~Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions."|time of response to progressive disease or death (up to 2 years follow-up)|All enrolled participants with at least completed cycle and who had a complete or partial response.||days||95% Confidence Interval|Median
166149|NCT00191984|Primary|Best Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment.~Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions.~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria."|baseline to measured progressive disease (up to 2 years follow-up)|All enrolled participants with at least one completed cycle.||participants|||Number
166150|NCT00191945|Secondary|Vital Signs - Weight||Baseline and 12 weeks|All randomized participants.||kilograms||Standard Deviation|Mean
166151|NCT00191945|Secondary|Vital Signs - Pulse||Baseline and 12 weeks|All randomized participants.||beats per minute||Standard Deviation|Mean
166152|NCT00191945|Secondary|Vital Signs - Diastolic Blood Pressure||Baseline and 12 weeks|All randomized participants.||mmHg||Standard Deviation|Mean
166153|NCT00191945|Secondary|Vital Signs - Systolic Blood Pressure||Baseline and 12 weeks|All randomized participants.||mmHg||Standard Deviation|Mean
166154|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 107|Intention to Treat analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
166155|NCT00191945|Secondary|Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL)|The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.|Baseline|Intention to Treat analysis. All randomized participants who took at least one dose of study drug.||participants|||Number
166156|NCT00191945|Secondary|Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks)|Parent-rated assessment of a child’s health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, ‘how good is your child at making friends?’ 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement.|Baseline to 12 weeks|Intention to Treat analysis. Last observation carried forward.||standard deviation units||Standard Deviation|Mean
166157|NCT00191945|Secondary|Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12)|The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81.|Baseline and Week 12|Intention to Treat analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
166158|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and Open-Label Endpoint (107 weeks)|Intention to Treat analysis. Last observation carried forward.||units on a scale||Standard Deviation|Mean
166159|NCT00191945|Secondary|Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks)|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline and 12 weeks|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
166160|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|week 6 and week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
166874|NCT00176488|Secondary|Biological Response to Epirubicin and Vinorelbine Administered in Patients With Breast Cancer in Sequential Tumor Biopsies and Peripheral Blood Mononuclear Cells.||10 years|Study was closed prematurely and insufficient data was collected.|||||
166161|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 4|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
166162|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 6|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
166163|NCT00191945|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Week 9|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
166164|NCT00191945|Primary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total Scores range from 0 to 54.|Week 12|Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.||units on a scale||Standard Deviation|Mean
166165|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
166166|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
166167|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
166168|NCT00191906|Secondary|Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones|Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
166169|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
166170|NCT00191906|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale|Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).|4 week therapy endpoint|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
166171|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||T-Score of units on a scale||Standard Error|Least Squares Mean
166875|NCT00176488|Primary|Efficacy of the Sequential Use of a DNA Damaging Drug (Epirubicin) Followed by a Vinca Alkaloid (Vinorelbine) in the Treatment of Breast Cancer.||10 years|Study was closed prematurely and insufficient data was collected.|||||
166172|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale|Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
166173|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale|Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
166174|NCT00191906|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score|Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is the sum of the scores on the 18 items and range from 0 to 54.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||units on a scale||Standard Error|Least Squares Mean
166175|NCT00191906|Secondary|Working Memory by Corsi Block Tapping Test (CBTT)|Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||blocks correctly sequenced||Standard Error|Least Squares Mean
166176|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Pseudo Words|Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
166177|NCT00191906|Secondary|Lexical Decision Task Mean Reaction Time: Correct Words|Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Error|Least Squares Mean
166178|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
166179|NCT00191906|Secondary|Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and 4 weeks of therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds||Standard Deviation|Mean
166180|NCT00191906|Primary|Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm|SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.|Baseline and Week 4 of initial therapy and Week 4 of crossover therapy|All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.||milliseconds (msec)||Standard Error|Least Squares Mean
166181|NCT00191854|Secondary|Overall Survival|Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up.|baseline to date of death from any cause (up to 34 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 23; Gemcitabine + Carboplatin = 24; Gemcitabine + Cisplatin = 22.||months||Full Range|Median
166182|NCT00191854|Secondary|Duration of Response|Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression.|time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Randomized patients who had either a complete response or partial response. Censored patients: Gemcitabine + Paclitaxel = 4; Gemcitabine + Carboplatin = 4; Gemcitabine + Cisplatin = 14.||months||95% Confidence Interval|Median
166183|NCT00191854|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment.|baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 20; Gemcitabine + Carboplatin = 18; Gemcitabine + Cisplatin = 28.||months||95% Confidence Interval|Median
166184|NCT00191854|Secondary|Number of Participants With a Time to Treatment Failure (TTTF) Event|TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation.|randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)|Number of randomized patients. Censored patients: Gemcitabine + Paclitaxel = 34; Gemcitabine + Carboplatin = 26; Gemcitabine + Cisplatin = 30.||participants|||Number
166185|NCT00191854|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)|Number of all randomized participants.||participants|||Number
166186|NCT00191815|Secondary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through eight 21-day cycles|Safety Population: all enrolled participants who received study drug.||participants|||Number
166187|NCT00191815|Secondary|Number of Deaths||Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|All enrolled participants.||participants|||Number
166188|NCT00191815|Secondary|Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades|Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.||participants|||Number
166189|NCT00191815|Secondary|Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination|The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)|Safety Population: all enrolled participants who received study drug.||participants|||Number
166190|NCT00191815|Secondary|Survival Time|Overall survival is the duration from enrollment to death due to any cause.|first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||weeks||95% Confidence Interval|Median
166191|NCT00191815|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.|first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||weeks||95% Confidence Interval|Median
166192|NCT00191815|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression.|first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||weeks||95% Confidence Interval|Median
175712|NCT00073073|Primary|Percent Change in Mammographic Density at 1 Year on Exemestane||1 year|||percent change from baseline||95% Confidence Interval|Mean
166193|NCT00191815|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)|Response population: all enrolled participants who had either a complete or partial response.||weeks||95% Confidence Interval|Median
166194|NCT00191815|Primary|Objective Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)|Efficacy Population: all enrolled participants who received study drug; did not have more than one neoadjuvant/adjuvant chemotherapy; had measurable disease; had prior neoadjuvant/adjuvant chemotherapy; and did not have prior chemotherapy for metastatic disease.||participants|||Number
166195|NCT00191789|Post-Hoc|Number of Participants With Time to Treatment Failure at Various Time Points|This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point.|baseline to stopping treatment (up to 68 months)|Intent to treat population.||participants|||Number
166196|NCT00191789|Post-Hoc|Number of Participants Who Died From Any Cause at Various Time Points|The cumulative number of participants with an event (death from any cause) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.||participants|||Number
166197|NCT00191789|Post-Hoc|Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study|The cumulative number of participants with an event (either progressive disease or death) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without progressive disease or still alive at the beginning of each time point.|baseline up to 68 months|Intent to treat population.||participants|||Number
166198|NCT00191789|Secondary|Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery|The extent and type of surgery was guided by the tumor size, physician and/or patient decision. It was either conservation surgery or mastectomy with axillary lymph node dissection. Results are reported on the number of patients who underwent breast conservation surgery.|baseline, after eight 21-day cycles of study drug|||participiants|||Number
166199|NCT00191789|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed. Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints.|baseline to stopping treatment (up to 68 months)|Upper limit of 95% Confidence Interval of median survival was not calculable.||weeks||95% Confidence Interval|Median
166200|NCT00191789|Secondary|Overall Survival|Overall survival was defined as the date of enrollment to the date of death from any cause. Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints.|baseline to date of death from any cause up to 68 months|Median was not reached||months||95% Confidence Interval|Median
166201|NCT00191789|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause. Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints.|baseline to measured progressive disease or death from any cause (up to 68 months)|Median was not reached.||months||95% Confidence Interval|Median
166202|NCT00191789|Secondary|Summary of Deaths During Study||baseline through last cycle on study drug (eight 21-day cycles)|Intent to treat population.||participants|||Number
166203|NCT00191789|Primary|Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)|Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.|tumor assessment at baseline and during surgery after eight 21-day treatment cycles|Intent to treat population.||participants|||Number
166204|NCT00191724|Secondary|Difference in Pulmonary Artery (PA) Pressure|Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.|baseline, day 6, day 90|Data were not collected.||mm Hg||Standard Deviation|Mean
166205|NCT00191724|Secondary|Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)|Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).|baseline and day 90 (follow-up)|Population was all randomized patients who received any study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline assessment were excluded from the analyses.||units on a scale||Standard Deviation|Mean
166251|NCT00191282|Secondary|Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166206|NCT00191724|Secondary|Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios|Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography|baseline, day 6, day 90|Population is all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo]. Patients who had no postbaseline measure at Day 6 or Day 90 were excluded from the analysis of change from baseline to day 6 or day 90, respectively.||ratio||Standard Deviation|Mean
166207|NCT00191724|Primary|Number of Participants With Major Bleeding Events|Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.|baseline through day 6|The population analyzed was all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo].||participants|||Number
166208|NCT00191646|Secondary|Overall Survival|Overall survival is defined as the duration from baseline to death. For participants who are still alive at the data cut-off date, survival will be censored at the last contact date. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to death from any cause up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 194 events, 220 censored. P/C Arm: 159 events, 254 censored.||months||95% Confidence Interval|Median
166209|NCT00191646|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the duration from date of randomization to the date of the first of the following events: early discontinuation of study therapy; progression of disease, or death due to any cause. Time to treatment failure will be censored at the date of the last follow-up visit for participants who did not discontinue early, who are still alive, and who have not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to stopping treatment up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 336 events, 78 censored. P/C Arm: 330 events, 83 censored.||months||95% Confidence Interval|Median
166210|NCT00191646|Secondary|Proportion of Participants With Response (Response Rate)|Response rate (RR) = proportion of participants with best overall Complete Response (CR: disappearance of all target lesions [TL]) or Partial Response (PR: 30% decrease in sum of longest diameter of TL). Induction therapy RR = number of participants with CR or PR during induction divided by number of participants with measurable disease at baseline (TL measurement during screening). Crossover therapy RR = number of participants with CR or PR during crossover divided by number of participants with measurable disease at baseline (latest TL measurement by first dose date of crossover therapy).|Baseline to measured progressive disease up to 82 months|All ITT participants with measurable disease at baseline (screening) for induction period; all ITT participants who crossed over to single agent therapy and had measurable disease before or at crossover for crossover period. Participants in consolidation therapy achieved CR during induction therapy and were not included in analysis.||proportion of responders||95% Confidence Interval|Mean
166211|NCT00191646|Primary|Progression Free Survival (PFS)|Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.|Baseline to measured progressive disease or death up to 82 months|Intent to treat (ITT) population, which includes all randomized participants. 3 participants in the Gemcitabine/Carboplatin treatment sequence were excluded due to missing data, and 1 participant in the Paclitaxel/Carboplatin treatment sequence was excluded for missing data. G/C Arm: 292 events, 122 censored. P/C Arm: 279 events, 134 censored.||Months||95% Confidence Interval|Median
166212|NCT00191477|Secondary|Tumor Recurrence Type|Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition).|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.||participants|||Number
166213|NCT00191477|Secondary|Recurrence-Free Survival (RFS) in Subgroups|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time for RFS was not reached in all subgroups, patients (%) with RFS are reported as post-hoc outcome #6. There was no statistically significant difference between treatment arms in any subgroup. Population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.||months||Full Range|Median
166248|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized participants who self-reported hypoglycemia during Month 1.||episodes of hypoglycemia|||Number
166214|NCT00191477|Secondary|Time to Recurrence|Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Because median time to recurrence was not reached in placebo arm, percentages of participants without recurrence are reported as post-hoc outcome measure (see #5. Post-hoc Outcome Measure). Efficacy Eligible population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.||months||Full Range|Median
166215|NCT00191477|Post-Hoc|Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months|RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population consists of the Full Analysis Set (randomized) participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.||percentage of participants|||Number
166216|NCT00191477|Post-Hoc|Percentage of Participants Without Tumor Recurrence|Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.|Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|Efficacy Eligible population contains the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.||percentage of participants|||Number
166217|NCT00191477|Primary|Recurrence-Free Survival (RFS)|Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.|Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)|This is the Full Analysis Set population and contains all randomized participants who received the single instillation of Gemcitabine or Placebo.||Months||Full Range|Median
166218|NCT00191451|Secondary|Percentage of Patients With Overall Survival at 1 Year and 2 Years|Kaplan-Meier estimates of overall survival (percentage of patients surviving) at 1 year and 2 years.|1 Year, 2 Years|Intent to treat population: all randomized patients. Censored patients: 31 HER2+; 19 HER2- (Taxane-); 9 HER2- (Taxane+).||percentage of participants|||Number
166219|NCT00191451|Secondary|Time to Disease Progression (TTP)|If a patient is lost to follow-up, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient died due to reason other than study disease, and patient has not progressed or received any new treatment, TTP is censored at the date of death.|randomization date to the earliest date of the first documented disease progression date or the date of death if the patient dies due to study disease (up to 3.5 years)|Intent to treat population: all randomized patients. Censored patients: 10 in HER2+, 20 in HER2- (Taxane-), and 12 in HER2- (Taxane+).||months||95% Confidence Interval|Median
166220|NCT00191451|Secondary|Number of Patients Who Experienced Alopecia||Baseline to 3.5 years|Number of patients who received at least one dose of study drug.||participants|||Number
166221|NCT00191451|Secondary|Duration of Response|Among tumor responders, the duration of tumor response is measured from the date of response (complete response [CR] or partial response [PR]) until the first date of documented progression or death from any cause. Duration of tumor response will be censored at the date of the last follow-up visit for tumor responders who are still alive and who have not progressed.|date of response (CR or PR) until the first date of documented progression or death from any cause (up to 3.5 years)|Number of patients with complete or partial response. Censored patients: 6 in HER2+, 6 in HER2- (Taxane-), and 5 in HER2- (Taxane+).||months||Full Range|Median
166222|NCT00191451|Primary|Overall Tumor Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to disease progression/recurrence (up to 3.5 years)|Efficacy evaluable subjects include all subjects who received at least 2 cycles of treatment with at least 1 follow-up tumor assessment, and did not violate the protocol in any fundamental manner related to the evaluation of efficacy.||participants|||Number
166223|NCT00191386|Secondary|Cytochrome P450 2D6 (CYP2D6) Phenotype Status|Participants were categorized as either extensive metabolizers (EM) or poor metabolizers (PM). CYP2D6 is the primary atomoxetine metabolizing enzyme. The CYP2D6 genotype were analysed by testing the *2, *3, *4, *5, *6, *7, *8, and *10 alleles. Metabolizer status was determined by focusing on the normal(wild type, *2), decreased(*10), and defective allele(*3, *4, *5, *6, *7, or *8). PM were assigned to the patients had two defective alleles in any combination of *3, *4, *5, *6, *7, or *8 alleles. EM was all except for PM.|Over 1 year|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.||Participants|||Number
166520|NCT00185692|Primary|Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning|number achieving donor cell engraftment (>95%) by day 90 after transplant.|100 days|||Participants|||Count of Participants
166224|NCT00191386|Secondary|Change From Baseline at Various Timepoints in the Clinical Global Impressions-Attention Deficit Hyperactivity Disorder-Severity (CGI-ADHD-S)|Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.||Units on a scale||Standard Deviation|Mean
166225|NCT00191386|Secondary|Change From Baseline at Various Timepoints in Attention Deficit Hyperactivity Disorder Rating Scale-IV-Translated in Japanese Parent Version: Investigator Administered and Scored (ADHDRS-IV-J:I) Total Score|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.|Baseline, 6 Months, 12 Months, 2 Years, 3 Years, 4 Years|Full Analysis Set: Participants who met Study LYBC criteria, took 1 dose of drug, had a baseline/post-baseline measurement. Changes from baseline used LOCF approach. Baseline was the last non-missing measurement before taking atomoxetine (either LYDA Week 0 or LYBC Week 2). Endpoint was the last non-missing measurement in each assessment period.||Units on a scale||Standard Deviation|Mean
166226|NCT00191386|Primary|Number of Participants With Adverse Events for Long Term Safety and Tolerability|Details on the actual adverse events are presented in the Reported Adverse Events Section.|Baseline through 4 years|All patients who took at least one dose of study medication were included in the analyses of safety data.||Participants|||Number
166227|NCT00191334|Secondary|Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade|Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).|every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||participants|||Number
166228|NCT00191334|Secondary|Time to Treatment Failure|Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||weeks||95% Confidence Interval|Median
166229|NCT00191334|Secondary|Time to Progressive Disease|Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||weeks||95% Confidence Interval|Median
166230|NCT00191334|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up|||weeks||95% Confidence Interval|Median
166231|NCT00191334|Primary|Best Overall Tumor Response|Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up|||participants|||Number
166232|NCT00191308|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.|Treatment start to death from any cause (up to 47.6 months)|OS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
166233|NCT00191308|Secondary|Disease Free Survival (DFS)|DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.|Treatment start to disease progression or death from any cause (up to 45.5 months)|DFS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.||months||95% Confidence Interval|Median
166234|NCT00191308|Secondary|Duration of Response|The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions.|Time of response to disease progression (up to 44.4 months)|Duration of response was analyzed on responders treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy; responder.||months||95% Confidence Interval|Median
166235|NCT00191308|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate)|Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.|Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)|Tumor response rate and 95% confidence interval (CI) of best CR or PR were evaluated on all qualified enrolled participants treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.||percentage of participants||95% Confidence Interval|Number
166249|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 1|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 3 (Month 1)|All randomized patients who took at least one dose of study drug.||participants|||Number
166236|NCT00191308|Primary|High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood|Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.|Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)|Due to lack of eligible participants, enrollment was stopped early when 30 participants were enrolled. Tumor samples were collected in only 19 of these 30 participants. Results obtained from analyses of a small number of available samples were considered to be of little scientific and medical relevance, and tumor-tissue analyses were not conducted.||participants|||Number
166237|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized participants with self-reported hypoglycemia during Month 18.||episodes of hypoglycemia|||Number
166238|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 18|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 8 (Month 18)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
166239|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized participants with self-reported hypoglycemia during Month 12.||episodes of hypoglycemia|||Number
166240|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 12|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 7 (Month 12)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
166241|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized participants with self-reported hypoglycemia during Month 9.||episodes of hypoglycemia|||Number
166242|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 9|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 6 (Month 9)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
166243|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized participants with self-reported hypoglycemia during Month 6.||episodes of hypoglycemia|||Number
166244|NCT00191282|Other Pre-specified|Summary of Reasons for Deaths||Randomization (Day 0) to death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166245|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 6|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 5 (Month 6)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
166246|NCT00191282|Secondary|Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized participants who self-reported hypoglycemia during Month 3.||episodes of hypoglycemia|||Number
166247|NCT00191282|Secondary|Number of Participants With Self-Reported Hypoglycemia During Month 3|Hypoglycemia was defined as any time a patient feels, or another person observes, that the patient is experiencing a sign/symptom which he/she would associate with hypoglycemia (for example, tremors, headache, sweating, disorientation, weakness, etc) or a blood glucose measurement less than 3.5 mmol/L (63 mg/dL).|Visit 4 (Month 3)|All randomized patients who took at least one dose of study drug and who were still in the study.||participants|||Number
166250|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Angiography Planned After Randomization||Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166252|NCT00191282|Secondary|Number of Participants Who Experienced Congestive Heart Failure|Occurrence of congestive heart failure (newly diagnosed after Visit 2).|Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166253|NCT00191282|Secondary|Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization||Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166254|NCT00191282|Secondary|Number of Participants Who Experienced Coronary Revascularization Procedures|Occurrence of all coronary revascularization procedures (angioplasty or coronary artery by-pass surgery) planned after randomization.|Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166255|NCT00191282|Secondary|Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)||Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166256|NCT00191282|Secondary|Number of Participants Who Experienced Stroke|Occurrence of stroke (fatal, nonfatal, any).|Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166257|NCT00191282|Secondary|Number of Participants Who Experienced Myocardial Infarction (MI)|Occurrence of myocardial infarction (MI) (fatal, nonfatal, any).|Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166258|NCT00191282|Secondary|Number of Participants Who Experienced Cardiovascular (CV) Death||Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166259|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause||Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166260|NCT00191282|Secondary|Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors|Primary outcomes adjusted for major cardiovascular (CV) risk factors (blood pressure, cholesterol [total, high density lipoprotein (HDL), and low density lipoprotein (LDL)], triglycerides, smoking, albuminuria, age, gender, and body mass index (BMI).|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166261|NCT00191282|Secondary|Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control|Indicators of metabolic control included glycosylated hemoglobin (HbA1c) and fasting blood glucose concentrations.|Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166262|NCT00191282|Secondary|Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes|Primary outcomes in this study consisted of: cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedure planned after randomization.|Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug.||participants|||Number
166263|NCT00191282|Primary|Number of Participants Who Experienced a Primary Combined Outcome|The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.|Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)|All randomized patients who took at least one dose of study drug||participants|||Number
166264|NCT00191269|Secondary|Pharmacokinetics - Normalized Area Under the Curve|Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.|cycle 1|Pharmacokinetic data were available on 12 participants.||nanograms times hour per milliliter||Full Range|Geometric Mean
166265|NCT00191269|Secondary|Pharmacokinetics - Normalized Cmax|maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.|cycle 1|Pharmacokinetic data were available from 12 patients.||nanograms per milliliter (ng/mL)||Full Range|Geometric Mean
166266|NCT00191269|Secondary|Survival at 1 Year|Results are reported as number of participants alive at one year.|baseline to date of death from any cause, evaluate at 1 year|||participants|||Number
166267|NCT00191269|Secondary|Time to Progressive Disease|Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|baseline to measured progressive disease|||days||95% Confidence Interval|Median
166268|NCT00191269|Secondary|Duration of Response|For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.|time of response to progressive disease|The 5 responding participants (complete response and partial response) at Dose Level 2.||months||95% Confidence Interval|Median
166269|NCT00191269|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease|||participants|||Number
166270|NCT00191191|Secondary|Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)|FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||units on a scale||Standard Deviation|Mean
166271|NCT00191191|Secondary|Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)|20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.|Baseline (pre-dose), 3 Months after first dose of Cycle 1|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||units on a scale||Standard Deviation|Mean
166272|NCT00191191|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||months||95% Confidence Interval|Median
166273|NCT00191191|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.|time of response to progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||months||95% Confidence Interval|Median
166274|NCT00191191|Primary|Best Overall Response|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.|baseline to measured progressive disease (up to 3.2 years)|Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.||participants|||Number
166275|NCT00191165|Secondary|Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient’s height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|24 Months|All enrolled participants with at least one post-baseline height velocity measurement, using the last observation available prior to the 24-month visit if the 24-month height velocity was not available.||standard deviation score||Standard Deviation|Mean
166276|NCT00191165|Secondary|Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS)|This was derived by subtracting the age-and-gender-matched population 50th percentile height from the patient’s height and then dividing this value by the age-and-gender-matched population height SD.|Baseline, 12-Months, 24-Months|All enrolled participants with at least one post-baseline height measurement, using last observation available prior to 12-month and 24-month visits respectively, if 12-month or 24-month height was not available.||standard deviation score||Standard Error|Least Squares Mean
166277|NCT00191165|Primary|Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint|Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient’s height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.|12-Months|All enrolled participants with baseline and 12-month height measurements.||standard deviation score||Standard Deviation|Mean
166278|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)|Participants with RSCL at baseline (conclusion of initial treatment)and end of crossover treatment||units on a scale||Standard Deviation|Mean
166279|NCT00191152|Secondary|Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)|RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].|Baseline until crossover treatment began (up to 82 months)|Participants with RSCL at baseline and end of initial treatment.||units on a scale||Standard Deviation|Mean
166280|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)|Participants with KPS at baseline (conclusion of initial treatment) and end of crossover treatment||units on a scale||Standard Deviation|Mean
166281|NCT00191152|Secondary|Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)|KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).|Baseline until crossover treatment began (up to 82 months)|Intent-to-treat population, initial treatment, participants with KPS at baseline and end of initial treatment.||units on a scale||Standard Deviation|Mean
166282|NCT00191152|Secondary|Best Overall Response (Crossover Treatment)|Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using RECIST criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|Only included participants who crossed over from initial treatment to crossover treatment.||participants|||Number
166283|NCT00191152|Secondary|Best Overall Response (Initial Treatment)|Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.|Best response from start of treatment until disease progression/recurrence (up to 82 months)|ITT population.||participants|||Number
166284|NCT00191152|Secondary|Overall Survival|Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.|Date of randomization to date of death from any cause (up to 82 months)|Intent to treat population: all randomized participant. Censored participants: 75 in gemcitabine/docetaxel arm; 72 in docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
166285|NCT00191152|Secondary|Duration of Response (Crossover Treatment)|At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over & achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.|Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)|ITT population: participants with CR or PR as best overall response at crossover treatment. Censored participants: 4 in capecitabine arm; 2 in gemcitabine arm.||months||95% Confidence Interval|Median
166286|NCT00191152|Secondary|Duration of Response (Initial Treatment)|Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.|Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)|ITT population: participants with CR or PR as best overall response (initial treatment). Censored participants: 16 in gemcitabine/docetaxel arm; 30 in docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
166287|NCT00191152|Primary|Time to Disease Progression (Initial Treatment)|Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.|Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)|Intent-to-treat (ITT) population: all randomized participants. Censored participants in initial treatment: 68 gemcitabine/docetaxel arm; 83 docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
166288|NCT00191152|Secondary|Progression-Free Survival (Crossover Treatment)|For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.|First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants, crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.||months||95% Confidence Interval|Median
166289|NCT00191152|Secondary|Progression-Free Survival (Initial Treatment)|For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.|Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)|ITT: all randomized participants. Censored participants (initial treatment): 64 in gemcitabine/docetaxel arm; 80 in docetaxel/capecitabine arm.||months||95% Confidence Interval|Median
166364|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
166290|NCT00191152|Secondary|Time to Disease Progression (Crossover Treatment)|For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.|Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)|ITT population: all randomized participants. Censored participants in crossover treatment: 13 in capecitabine arm; 10 in gemcitabine arm.||months||95% Confidence Interval|Median
166291|NCT00191139|Secondary|Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization|LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met.|baseline to 3 months after last dose of study treatment (three 21-day cycles)|as-treated population||participants|||Number
166292|NCT00191139|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact.|baseline to date of death from any cause up to 2057 days|ITT population||days||95% Confidence Interval|Median
166293|NCT00191139|Secondary|Progression-Free Survival|Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed.|baseline to measured progressive disease up to 2057 days|ITT population||days||95% Confidence Interval|Median
166294|NCT00191139|Secondary|Number of Patients With Overall Tumor Response|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR).|randomization and every 3 months up to 2 years of post-study followup|ITT population||participants|||Number
166295|NCT00191139|Primary|2-Year Survival|Percentage of participants alive at 2 years.|2 years|Intention to treat (ITT) population||percentage of participants|||Number
166296|NCT00191113|Secondary|Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data.||participants|||Number
166297|NCT00191113|Secondary|Maximum Glycosylated Hemoglobin|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||percent (%)||Standard Deviation|Mean
166298|NCT00191113|Secondary|Glycosylated Hemoglobin, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.||percent (%)||Standard Error|Least Squares Mean
166299|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value|Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data. Calculated only for patients with fasting blood <100 mg/dL.||participants|||Number
166300|NCT00191113|Secondary|Minimum Fasting Glucose/Insulin Ratio Values|Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||milligrams per 10^-4 Units (mg/[10^-4]U)||Standard Deviation|Mean
166301|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Insulin Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data||participants|||Number
166302|NCT00191113|Secondary|Maximum Fasting Insulin Values|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||micro International Units per milliliter||Standard Deviation|Mean
166303|NCT00191113|Secondary|Number of Participants With Any Abnormal Fasting Glucose Value|Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL).|At start and through end of 4-year addendum|Patients with any Addendum 2 glucose metabolism data||participants|||Number
166304|NCT00191113|Secondary|Maximum Fasting Glucose Value|Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.|At start and through end of 4-year addendum (up to an additional 2 years)|Patients with addendum data who were followed for at least 4 years without growth hormone treatment (and never received growth hormone) or who received growth hormone for at least 4 years.||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
166305|NCT00191113|Secondary|Fasting Glucose, Change From Baseline|Change from core study baseline to addendum 2 maximum.|At core study baseline, and at end of 4-year addendum|Patients who were followed for at least 4 years without growth hormone treatment or who received growth hormone for at least 4 years, and who were treated as randomized and had core study baseline and addendum glucose metabolism data.||mg / dL||Standard Error|Least Squares Mean
166306|NCT00191113|Secondary|Number of Participants With Hearing Loss, Audiologist Assessment|Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.|at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination for whom Audiologist responded to Hearing Loss question||participants|||Number
166307|NCT00191113|Secondary|Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination||participants|||Number
166308|NCT00191113|Secondary|Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination||participants|||Number
166309|NCT00191113|Secondary|Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment||at completion of core study or beginning of addendum|All Randomized Patients with Hearing Examination||participants|||Number
166310|NCT00191113|Secondary|Height (Centimeters [cm])|Most mature measurement available, at or after attainment of Final Height.|every 3 months during core study, and at start and end of 4-year addendum|||centimeters (cm)||Standard Error|Least Squares Mean
166311|NCT00191113|Secondary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|every 3 months during core study, and at start and end of 4-year addendum|||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
166312|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height|SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.|at completion of core study, or at end of 4-year addendum|Population of patients for whom Final Height measurements are available. Efficacy analysis with as-treated treatment groups, at most mature measurement available at or after attainment of Final Height.||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
166313|NCT00191113|Primary|Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population|Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.|Baseline, and end of 4-year addendum|Population of all randomized patients. Intent to treat analysis with as-randomized treatment groups, at most mature measurement available.||Standard Deviation Score (SDS) [NCHS]||Standard Error|Least Squares Mean
166314|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points|Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.||participants|||Number
166315|NCT00191100|Secondary|Number of Participants Who Died From Any Cause at Various Time Points|Original outcome was Overall Survival, which was defined as time from baseline to death from any cause.|baseline to date of death from any cause (includes 60 month follow-up period)|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.||participants|||Number
166316|NCT00191100|Secondary|Tumor Response|Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned.||participants|||Number
166317|NCT00191100|Secondary|Local Failure Rate|Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b).|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received.||proportion of participants with PD|||Number
166318|NCT00191100|Secondary|Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points|Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented.|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.||participants|||Number
166319|NCT00191100|Primary|Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years|"Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted Measure Type, so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented."|Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively|Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned.||participants|||Number
166320|NCT00190983|Secondary|Overall Survival|Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.|baseline until death from any cause (up to 5 years)|||months||Full Range|Median
166321|NCT00190983|Secondary|Progression-Free Survival|The period from study entry until disease progression, death or date of last contact.|baseline until documented tumor progression (up to 5 years)|All enrolled participants who experienced disease progression.||months||Full Range|Median
166322|NCT00190983|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.|time of initial response until documented tumor progression (up to 5 years)|All enrolled participants who had either a complete response (n=0) or partial response (n=4).||months||Full Range|Median
166323|NCT00190983|Primary|Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|baseline to measured progressive disease (up to 5 years)|||participants|||Number
166324|NCT00190775|Secondary|Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, after 2-week titration period beginning at Week 24|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166325|NCT00190775|Secondary|Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 2 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166326|NCT00190775|Secondary|Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 1 week|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166327|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)|Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant reports how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166408|NCT00190671|Primary|Best Tumor Response|Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.|baseline to measured progressive disease|Number of randomized participants.||participants|||Number
166328|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)|The MADRS is an investigator administered rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166329|NCT00190775|Secondary|Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the severity of ADHD symptoms in relation to the clinician’s total experience with ADHD subjects. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). The scale was administered by a physician or PhD at the investigative site.|Baseline, 8 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166330|NCT00190775|Secondary|Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores|18-item scale that captures the 18-item DSM-IV symptoms of ADHD. 9 inattentive items alternate with 9 hyperactive/impulsive items. Each item is scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score range is 0-54 (0-27 for each subscale). Higher scores indicate more impaired participants. The scale was administered by a physician or PhD at the investigative site.|Baseline, 12 weeks, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166331|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166332|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale|16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166333|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags|Items 19-26 of the CDBRS assess the presence of Oppositional Defiant Disorder (ODD) (yes if participant answers >=4 items as 2 [often] or 3 [very often]). Items 1-26 are rated on a 0-3 scale (0=never/rarely, 1=sometimes, 2=often, 3=very often). 15 yes/no items assess the presence of Conduct Disorder (yes if >3 items answered yes). Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Participants|||Number
166334|NCT00190775|Secondary|Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form|Contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscale). Higher scores indicate greater impairment. Participants with a child 6-12 years old living in the home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166335|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 24 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166336|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.|Baseline, 12 Weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166443|NCT00189137|Secondary|The Percentage of Patients Alive Without Disease at 2 Years|Disease-free survival|2 years|||percentage of patients|||Number
166337|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166338|NCT00190775|Secondary|Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form|42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.|Baseline, 12 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166339|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166340|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166341|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166342|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166343|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains|120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166344|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress|The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||Units on a scale||Standard Deviation|Mean
166345|NCT00190775|Primary|Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 12 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included. The protocol was amended to extend the open-label portion of the study from 8 weeks to 12 weeks, and the primary objective was modified to include the CAARS-IV:SV at 12 weeks.||Units on a scale||Standard Error|Least Squares Mean
166346|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166347|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other|32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166348|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166349|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant|32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166350|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166351|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166381|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166521|NCT00185679|Secondary|Platelet Recovery|Number of subjects recovering platelets to > 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions|40 days|||participants|||Number
166352|NCT00190775|Secondary|Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 24 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166353|NCT00190775|Secondary|Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant|FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.|Baseline, 8 weeks|Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.||T-scores of units on a scale||Standard Deviation|Mean
166354|NCT00190775|Primary|Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score|30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.|Baseline, 24 weeks|Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included.||Units on a scale||Standard Error|Least Squares Mean
166355|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses|Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.|baseline and 12 weeks.|Mean change from baseline, all randomized patients, double-blind treatment period||nanomoles per Liter (nmol/L)||Standard Deviation|Mean
166356|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides|Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
166357|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)|Fasting lipid parameters including HDL change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
166358|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)|Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
166359|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol|Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.|baseline and 12 weeks|Change from baseline to last observation, all randomized patients, double-blind treatment period||millimoles per Liter (mmol/L)||Standard Deviation|Mean
166360|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores|Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
166361|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores|Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
166362|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores|The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
166363|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores|A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.|baseline and 12 weeks|Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
166444|NCT00189137|Primary|Percentage of Patients Hospitalized in Each Arm.|To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma.|12 weeks|||percentage of patients hospitalized|||Number
166365|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores|Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.|baseline and 12 weeks|BPRS Total and Subscale Scores-Change from Baseline to Last Observation Carried Forward, all randomized patients, double-blind treatment period||units on a scale||Standard Deviation|Mean
166366|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area|Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation of randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||ratio in square centimeters (cm2)||Standard Deviation|Mean
166367|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area|Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan change from baseline to last observation for randomized patients who completed baseline and endpoint clamps with both diet stabilizations||square centimeters (cm2)||Standard Deviation|Mean
166368|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Visceral Fat Area|Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period|baseline and 12 weeks|Abdominal CT scan of changes from baseline to last observation of randomized patients who completed baseline and endpoint clamps with both diet stabilizations||square centimeters (cm2)||Standard Deviation|Mean
166369|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Waist Circumference|Waist circumference change from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||centimeters||Standard Deviation|Mean
166370|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Weight change from baseline to last visit (last observation carried forward)|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||kilograms||Standard Deviation|Mean
166371|NCT00190749|Secondary|Change From Baseline to 12 Week Endpoint in Body Mass Index|Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.|baseline and 12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||kilograms per square meter (kg/m2)||Standard Deviation|Mean
166372|NCT00190749|Secondary|Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166373|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166374|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||correlation|||Number
166375|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations||correlation|||Number
166376|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166377|NCT00190749|Secondary|Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166378|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Abnormal Involuntary Movement Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166379|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Clinical Global Impression-Severity of Illness scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166380|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.|Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Brief Psychiatric Rating Scale scores|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166382|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166383|NCT00190749|Secondary|Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.|Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight|12 weeks|Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.||correlation|||Number
166384|NCT00190749|Primary|Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate|Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:[(mg glucose)*min*mL] / [(kg fat free body mass)*(micro IU insulin)]|baseline and 12 weeks|N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight.||Mffm/I||Standard Deviation|Mean
166385|NCT00190684|Primary|Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group|"Tanner Stage:~I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs~Age Groups:~age<11.0 (female) and age<12 (male)~11=<age<12 (female) or 12<=age<13 (male)~12=<age<15 (female) or 13=<age<15 (male)~age>=15 (female and male)"|1 year through 5 years|The analysis population is defined as patients with at least two Tanner measurements.||participants|||Number
166386|NCT00190684|Primary|Number of Participants With Abnormal Laboratory Analytes During the Study|Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10^12 units/liter; Giga/liter (GI/L)or 10^9 units/liter; femtoliters (fL); urinalysis (UA)|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||participants|||Number
166387|NCT00190684|Primary|Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is <430 ms, Borderline is >=430 ms and <450 ms, Prolonged is >=450 ms. For Females: Normal is <450 ms, Borderline is >=450 ms and <470 ms, Prolonged is >=470 ms.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||participants|||Number
166388|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test|Only patients who took the Stroop Color Word Test in a previous atomoxetine study were required to complete the Stroop in this study. Stroop measures inhibition of dominant response and interference control. Patients were given tasks of recognition (colors), reading (where a word represents a color), and interference (reading words written in different colors). There were 100 items for each of the three categories and if they made it through 100 words with time remaining, they would repeat the list. Only a small number of patients had Stroop tests in this study, so no analysis was done.|baseline, 5 years|There were not enough participants with prior Stroop Word Color tests to analyze the data.||number of correct answers||Standard Deviation|Mean
166389|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores|A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||units on a scale||Standard Deviation|Mean
166390|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score|Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||units on a scale||Standard Deviation|Mean
166391|NCT00190684|Secondary|Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Hyperactive/Impulsive and Inattention Subscales consisted of 9 items each, for total subscale score range of 0 to 27. ADHD Index Subscale consisted of 12 items, for total score range of 0 to 36.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||units on a scale||Standard Deviation|Mean
166407|NCT00190671|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from the date of the first treatment dose to the first date of progressive disease or death from study disease.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). Time to disease progression was censored for 26 (42.6%) participants.||months||95% Confidence Interval|Median
166392|NCT00190684|Primary|Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)|QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.|baseline through 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||participants|||Number
166393|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Heart Rate|Patients were assessed for changes in heart rate using electrocardiogram.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||beats per minute (bpm)||Standard Deviation|Mean
166394|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)|Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||milliseconds (msec)||Standard Deviation|Mean
166395|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile|Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.|baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and 5 year endpoint measurement.||percentiles||Standard Deviation|Mean
166396|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Height||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||centimeters (cm)||Standard Deviation|Mean
166397|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Body Weight||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||kilograms (kg)||Standard Deviation|Mean
166398|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in Pulse||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||beats per minute (bpm)||Standard Deviation|Mean
166399|NCT00190684|Primary|Change From Baseline to 5 Year Endpoint in BP||baseline, 5 years|The number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug.||millimeters of Mercury (mmHg)||Standard Deviation|Mean
166400|NCT00190684|Primary|Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study|Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.|Baseline through 5 years|For each vital sign, the number of participants analyzed was defined as all patients with a baseline and post-baseline measurement, except patients reported as not taking any study drug. Number of subject analyzed for each vital sign is provided.||participants|||Number
166401|NCT00190671|Secondary|Pharmacokinetics - Half-Life (t½)|The half-life associated with the terminal elimination rate constant.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||hours||Full Range|Geometric Mean
166402|NCT00190671|Secondary|Pharmacokinetics - Volume of Distribution|Central volume (V1) and peripheral volume (V2) of distribution.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||Liters||Full Range|Geometric Mean
166403|NCT00190671|Secondary|Pharmacokinetics - Clearance (CL)|Total body clearance of drug calculated after intravenous administration.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||milliliters per minute||Full Range|Geometric Mean
166404|NCT00190671|Secondary|Pharmacokinetics - Area Under the Curve (AUC)|Area under the gemcitabine concentration-time curve from zero to last quantifiable concentration [AUC(0-t)] was calculated by combination of linear and logarithmic trapezoidal methods. Linear trapezoidal method was employed up to tmax (time to reach maximal concentration), and then log trapezoidal method was used for those data after tmax.|cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||hour times microgram per milliliter||Full Range|Geometric Mean
166405|NCT00190671|Secondary|Pharmacokinetics - Maximum Observed Drug Concentration (Cmax)||cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion)|Number of participants included in the pharmacokinetic analyses.||micrograms per milliliters||Full Range|Geometric Mean
166406|NCT00190671|Secondary|Progression Free Survival|Defined as date of first treatment dose to first date of progressive disease or death from any cause. For patients not known to have died as of data cutoff date and who did not have progressive disease, the progression free survival date was censored at last contact date.|baseline to measured progressive disease|All randomized participants in the Phase 2 portion of the trial (enrollment in 600mg/m2 arm stopped during Phase 1 and was not continued in Phase 2). The Progression Free Survival date was censored for 22 (35.07%) participants.||months||95% Confidence Interval|Median
166409|NCT00187720|Primary|Renal Clearance of Metformin|To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.|0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours|Analysis was per protocol. The sample size of 23 subjects will enable us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the renal clearance of metformin between individuals who are homozygous for the reference OCT2 and those who carry the OCT2 variant A270S allele.||mL/min||Standard Deviation|Mean
166410|NCT00187681|Primary|Glucose Lowering Response to Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered glucose lowering response to metformin we will measure the difference in area under the glucose concentrations-time curve (Glucose AUC) following oral glucose tolerance test.|0 to 180 minutes|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacodynamics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.||min * mg/dL||Standard Deviation|Mean
166411|NCT00187681|Primary|Area Under the Curve (AUC) of Blood Concentration-time of Metformin|To test whether individuals with genetic variants of human organic cation transporter, OCT1, exhibit altered pharmacokinetics of metformin, the difference in AUC of blood concentration-time of metformin between reference and variant groups will be measured.|0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours|20 participants were analyzed as per protocol. The sample size of 20 subjects enabled us to detect a significant difference (at the p < 0.05 level; α = 0.05, β = 0.80) in the pharmacokinetics of metformin between individuals who are homozygous for the reference OCT1 and those who carry an OCT1-R61C, OCT1-G401S or OCT1-G465R allele.||hour * µg/L||Standard Deviation|Mean
166412|NCT00187655|Primary|Effect of OAT3 on Renal Secretion of Cefotaxime IV Based on Genotype|Participants were stratified by their OCT3 genotype, heterozygous vs homozygous. The renal clearance of cefotaxime was measured by urine content of cefotaxime metabolites in participants after the single IV push administration of 2 grams of cefotaxime.|post dose up to 24 hours|The OAT3 Ile305Phe variant was determined to be heterozygous or homozygous for each healthy participant.||mL/min||Standard Deviation|Mean
166413|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Toe Brachial Index (TBI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)||mm Hg / mm Hg||Standard Error|Mean
166414|NCT00189540|Secondary|Change in Hemodynamic Measurements - Mean Change in Ankle Brachial Index (ABI)||Baseline, Month 3, Month 6|Population is per protocol - Efficacy Evaluable (EE)||mm Hg / mm Hg||Standard Error|Mean
166415|NCT00189540|Secondary|Number of Subjects Who Undergo a Major Amputation||Month 3 and Month 6|||participants|||Number
166416|NCT00189540|Secondary|Change in Pain at Rest as Measured on the Visual Analog Scale (VAS)|The mean VAS score where 0 = no pain; 10 = worst possible pain.|Baseline, Month 3 and Month 6|"Per protocol population or Efficacy Evaluable EE"||cm||Standard Error|Mean
166417|NCT00189540|Secondary|Percentage of Participants Where All Ulcers Healed|This outcome is a percentage of participants where all of their baseline ulcers healed.|Month 3 and Month 6|"Per protocol population Efficacy Evaluable EE"||Percentage of Participants|||Number
166418|NCT00189540|Primary|Wound Healing (Change in Total Wound Area of All Ischemic Ulcers)|Wound healing measured by change in mean total wound area of all ischemic ulcers at Month 3 and Month 6|Baseline, Month 3, Month 6|Per protocol population - Efficacy Evaluable or EE||total wound area (cm^2)||Standard Error|Mean
166419|NCT00189488|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The modified Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS.~The modified OMDQ was completed once daily beginning with the first day of study drug administration through day 28.~The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness)."|The first day of study drug administration through Day 28.|Primary analysis set||MTS score * days||Standard Deviation|Mean
166420|NCT00189488|Secondary|Duration of Hospitalization|Duration of hospitalization was defined as the number of days a participant stayed in hospital (hospitalized) during the period starting from the day of the transplant (Day 0) to the 100th day following the transplant.|From transplant (Day 0) until Day 100|Primary analysis set||days||Standard Deviation|Mean
166421|NCT00189488|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|From transplant (Day 0) until Day 100|Primary Analysis Set||Participants|||Number
166422|NCT00189488|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis was calculated as the number of days from the onset of severe mucositis (first time a WHO grade of 3 or 4 was observed) to the last day when severe mucositis was observed. If oral mucositis assessments were recorded as missed visits immediately prior to or immediately after severe mucositis was recorded, the missed visits were considered to be severe oral mucositis.|From transplant (Day 0) until Day 100|Primary Analysis Set||days||Standard Deviation|Mean
166423|NCT00189488|Secondary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|"Oral cavity assessments were performed by a trained assessor using the World Health Organization (WHO) oral toxicity scale. Daily oral mucositis assessments were performed:~while participants were hospitalized, including the day of discharge (maximum until day 28);~after discharge until the oral mucositis grade returns to a WHO grade ≤ 2.~The WHO oral toxicity criteria are: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|From transplant (Day 0) until Day 100|Primary Analysis Set||Participants|||Number
166424|NCT00189488|Secondary|Number of Participants With Day 11 Methotrexate Graft Versus Host Disease Prophylaxis Administration|Low dose methotrexate is widely used in regimens to prophylax against acute GVHD. Methotrexate was administered on days 1, 3, 6 and 11 (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2, respectively.|Day 11|Primary Analysis Set||Participants|||Number
167482|NCT00165698|Secondary|Bone Biomarker Undercarboxylated Osteocalcin (UCOC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of UCOC||Inter-Quartile Range|Median
166425|NCT00189488|Primary|Number of Participants With Severe (Grade 3 and 4) Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.~Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.~Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.~Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments. Efficacy analyses were according to randomized treatment assignment.||Participants|||Number
166426|NCT00189488|Secondary|Number of Participants With Grade 2 to 4 Acute Graft Versus Host Disease (GVHD)|"GVHD was graded using the modified Keystone Criteria weekly during the first 2 months after stem cell infusion, then every other week until Day 100.~Severity was determined clinically (based on physical exam and laboratory serum values) and from biopsies of affected organs whenever possible. The degree of GVHD in individual organs was scored by at least 2 assessors.~Grade 2 GVHD = > 50% skin involvement or total bilirubin 2.0 - 3.0 mg/dL or 500 - 999 mL/day diarrhea, or persistent nausea with histologic evidence.~Grade 3 GVHD = total bilirubin 3.1 - 15.0 mg/dL or ≥ 1000 mL/day diarrhea or severe abdominal pain with/without ileus.~Grade 4 GVHD = skin involvement with bullous formation or total bilirubin > 15.0 mg/dL."|From transplant (Day 0) until Day 100|Primary Analysis Set (consisting of all randomized participants) with GVHD assessments.||Participants|||Number
166427|NCT00189475|Primary|Nasal Secretion Weights||6 days after naturally acquiring an upper respiratory infection|||grams||Standard Error|Mean
166428|NCT00189462|Primary|Incidence of Acute Otitis Media||16 weeks|||participants with AOM|||Number
166429|NCT00189436|Secondary|Spirometry Readings||3 weeks||||||
166430|NCT00189436|Secondary|Urinary Cortisol||3 weeks||||||
166431|NCT00189436|Primary|Wheezing/Asthma/Bronchospasm Relapse Rate|Asthma relapse rate was 6.5% and 4% in the nebulized budesonide and standard care groups, respectively|3 weeks|||percentage of cases of asthma relapse|||Number
166432|NCT00189423|Secondary|Neurological Recovery at Hospital Discharge, 30 Days, 90 Days, and 1 Year [Measured by Cerebral Performance Category (CPC), Overall Performance Category (OPC), and Health Utilities Index Mark 3 (HUI3); Cognitive Abilities Screening Instrument (CASI)]||Various: hospital discharge through 1-year survival||||||
166433|NCT00189423|Secondary|Survival to 365 Days|Number of patients who are alive 365 days after the index cardiac arrest.|365 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met initial and final inclusion criteria.||patients|||Number
166434|NCT00189423|Secondary|Survival to 90 Days|Number of patients who are known to be alive 90 days after the index cardiac arrest.|90 days following cardiac arrest|Population is a modified Intent to Treat (mITT) population that met initial and final inclusion criteria.||patients|||Number
166435|NCT00189423|Secondary|Survival to Hospital Discharge||cardiac arrest to hospital discharge|||patients|||Number
166436|NCT00189423|Secondary|Survival to 24 Hours|Number of patients who were alive 24 hours after the initial cardiac arrest.|24 hours following cardiac arrest|Population is a modified Intent to Treat (mITT) population who met ititial inclusion criteria and final inclusion criteria.||patients|||Number
166437|NCT00189423|Secondary|Survival to Hospital (e.g., Intensive Care Unit) Admission|Number of patients who survived to hospital or ICU admission after being transported to the emergency department (ED) after out-of-hospital cardiac arrest.|Time of hospital admission, up to 1 day after cardiac arrest|Population is a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and also met final inclusion criteria.||patients|||Number
166438|NCT00189423|Secondary|Return of Spontaneous Circulation (ROSC)|Number of subjects who had ROSC, defined as any return of spontaneous circulation for any duration, reported during resuscitation in the field by EMS.|Time of cardiac arrest until discontinuation of efforts|Population was a modified Intent to Treat (mITT) population that consisted of patients who met all initial and final inclusion criteria.||patients|||Number
166439|NCT00189423|Secondary|Major Adverse Event Rate as Measured by Number of Patients With One or More Adverse Events|Number of patients with one or more major adverse events, through hospital discharge. Major adverse events included: death, rearrest, pulmonary edema, seizure, bleeding requiring intervention, rib/sterna fracture, pneumothorax, hemothorax, cardiac tamponade, cerebral bleeding, aspiration, internal organ injury.|Time from cardiac arrest through hospital discharge (an average of 12 days for subjects surviving to hospital discharge|Population is a modified Intent to Treat (mITT) population consisting of patients who met all initial and final inclusion criteria.||patients|||Number
166440|NCT00189423|Primary|Number of Patients Who Survived to Hospital Discharge With Favorable Neurologic Function Defined as MRS Score <=3|favorable neurologic function is defined as modified Rankin Scale (MRS) score <= 3. Modified Rankin Scale measures functional outcome in stroke. It is a scale of 0-5 where 0=no symptoms at all and 5=severe disability: bedridden, incontinent, and requiring constant nursing care and attention.|When the subject is discharged from the hospital; an average of 12 days after cardiac arrest for subjects surviving to hospital discharge|The population was a modified Intent to Treat (mITT) population who received EMS CPR per study protocol after meeting initial inclusion criteria and who were finally included in the final analysis population after meeting final inclusion criteria.||patients|||Number
166441|NCT00189306|Secondary|Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks|Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)|12 week posttreatment visit|Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen.||participants|||Number
166442|NCT00189306|Primary|Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)|Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.|5 years|2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required||participants|||Number
166445|NCT00189098|Secondary|Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.|After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|between 12 weeks and 1 year follow-up|||participants|||Number
166446|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 12 weeks and 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.||participants|||Number
166447|NCT00189098|Secondary|Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.|between 6 and 12 weeks follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.||participants|||Number
166448|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits.|between 12 weeks to 1 year follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.||participants|||Number
166449|NCT00189098|Secondary|Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits.|Between 6 to12 week follow up|Parents kept a diary of study medication and additional medication used for their child’s’ ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.||participants|||Number
166450|NCT00189098|Primary|Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear|The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope.|6, 12 weeks and 1 year follow-up.|intention to treat||participants|||Number
166451|NCT00187889|Secondary|Microvascular Coronary Flow Reserve(Adjusted) at Week 16 Adjusted for Baseline Coronary Flow Reserve Comparing the Eplerenone Group to the Placebo Group|Coronary flow reserve is a ratio of coronary blood flow velocity before and after adenosine. The outcome measure is the difference between the coronary flow reserve at 16 weeks adjusted for coronary flow reserve at baseline.|16 weeks|See Primary Outcome. The studied was only powered for the primary outcome. All completers are included per protocol analysis.||difference of ratios (unitless)||Standard Deviation|Mean
166452|NCT00187889|Primary|Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group|The primary measure was the relative change in coronary diameter to acetylcholinem (ACH) at 16 weeks adjusted for baseline reactivity to acetylcholine. Change in coronary artery diameter after ACH was measured in mm at baseline and 16 weeks. Percent change at 16 weeks - percent change at baseline was the outcome.|16 weeks|power analysis: Study planned to detect a 12% difference in change from baseline to 16 weeks between treatment groups (SD=14%), in the primary outcome leading to a planned sample size of 22 per group (44 total) for 80% power, P=0.05 2-sided. Study allowed for 6 dropouts, leading to a final N=50 planned (25 per group). Per protocol analysis used.||% change wk16-%change wk0- unitless||Standard Deviation|Mean
166453|NCT00187876|Primary|International Knee Documentation Committee (IKDC) Form|The IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.|24 month period|||score||95% Confidence Interval|Mean
166454|NCT00187486|Secondary|Progression Free Survival|Progression based on MR imaging using the Modified McDonnald Criteria defined as 25% increase in sum of products of all measured lesions or any new lesion|every 2 months measure by MR imaging, up to 39 months|||months||Full Range|Median
166455|NCT00187486|Primary|Overall Survival|Patients were monitored until death|assessment of survival was every 2 months, up to 181 weeks|The analysis was per protocol, and intention to treat. Median overall survival measured from the date of registration was the primary endpoint.||months||Full Range|Median
166456|NCT00187226|Primary|Local Tumor Control|Local tumor control was determined by Magnetic Resonance Imaging (MRI) of the brain and spine performed after radiation therapy. Imaging studies were performed every 3-4 months during the first three years and then every 6 months through five years. Imaging studies demonstrating tumor progression were electronically registered to the imaging data used to plan therapy. Local failure included tumor progression within the volume that received the prescribed dose of irradiation.|12 months after the enrollment of the last therapeutic patient|Patients with Ependymoma, Craniopharyngioma, Low-grade Glioma, and High-grade Glioma were analyzed by diagnosis.||Proportion of patients||95% Confidence Interval|Log Mean
166522|NCT00185679|Secondary|Acute GvHD (Grade II-IV)|Number of subjects with acute GvHD (grade II-IV) within 100 days post-transplant, per the Consensus Conference on Acute GvHD Grading (Przepiorka D, et al. Bone Marrow Transplantation. 1995. 15:825-828).|within 100 days post-transplant|||participants|||Number
166457|NCT00187200|Secondary|Left Ventricular Ejection Fraction (LVEF)|Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The left ventricle is the heart's main pumping chamber, so ejection fraction is usually measured only in the left ventricle (LV).|Randomization and 9 months|||percentage||Standard Deviation|Mean
166458|NCT00187200|Secondary|6 Minute Hall Walk Distance Test (6-MHWD)|Patients were considered non-responders if the 6-MHWD had not improved by greater than or equal to 10% compared to baseline. This statement is accurate and appropriate.|6 months|||participants|||Number
166459|NCT00187200|Secondary|NYHA Class Progression|New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.|6 months|Per protocol analysis||participants|||Number
166460|NCT00187200|Primary|CRT Responder Rate|Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.|6 months|Per protocol analysis.||participants|||Number
166461|NCT00187135|Secondary|Movement|Movement (yes/no) measured during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
166462|NCT00187135|Secondary|20% or Greater Change in Blood Pressure|Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
166463|NCT00187135|Secondary|20% or Greater Change in Respiratory Rate|Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
166464|NCT00187135|Secondary|20% or Greater Change in Heart Rate|Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo.||Participants|||Number
166465|NCT00187135|Primary|Pain (Yes/No)|During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 – 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded “pain”, and score of 0 was coded “no pain”, yielding one score for each participant’s procedure.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.||Participants|||Number
166466|NCT00187135|Primary|Pain(Yes/No)|During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 – 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded “pain”, and score of 0 was coded “no pain”, yielding one score for each participant’s procedure.|The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care.|Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow.||Participants|||Number
166467|NCT00187096|Secondary|Overall Survival|"Overall survival is defined as the time relapse from on study date to death with those alive at last follow up date censored. The Kaplan-Meier method was used to compute survival probability estimates and confidence interval was determined by binomial distribution (for no events or all events) or by log hazard method. The binomial interval is based on the number of patients at risk.~The confidence intervals for Arm 1 and Arm 2a were determined by binomial distribution.~The confidence interval for Arm 2b was determined by log hazard method."|Up to 2 years post NK cell transplantation|||Percent probability||95% Confidence Interval|Number
166468|NCT00187096|Secondary|Relapse-free Survival|For Arm 1, the efficacy of NK cell transplantation will be reported as the proportion of participants who achieve complete or partial remission. Kaplan-Meier estimates of relapse-free survival and confidence interval was determined by binomial distribution because no events were observed. The binomial interval is based on the number of patients at risk.|Up to 2 years post NK cell transplantation|||Percent probability||95% Confidence Interval|Number
166469|NCT00187096|Secondary|Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562)|NK cells in recipient achieving ability to lyse target cell line (K562) within normal range established by donor NK cells.|Days 2, 7, 14, 21, and 28 after NK cell transplantation|All 10 participants received NK donor cells; 9 of the 10 participants received KIR-mismatched NK donor cells.||participants|||Number
166470|NCT00187096|Secondary|Number of KIR-mismatched NK Cells|Number of KIR-mismatched donor NK cells in recipients’ blood at day 2 and day 14 post NK cell infusion.|Day 2 and day 14 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.||cells/µl||Full Range|Median
166471|NCT00187096|Secondary|Day That Maximum NK Cell Engraftment Was Reached|The time elapsed after transplantation in days until peak KIR-mismatched donor NK cell expansion was reached in recipients|Day 0 through Day 28 post NK cell transplantation|Nine of the 10 participants in Arm 1 received KIR-mismatched NK donor cells.||number of days||Full Range|Median
166472|NCT00187096|Secondary|Percent of Detectable Donor NK Cells at Day 28|The percent of detectable donor NK cells in recipients at 28 days after NK cell infusion. Three of 10 participants had detectable donor cells at week 4. The results report the percent of detectable cells in the 3 participants.|At 28 days|Three of 10 participants continued to have detectable donor NK cells at week 4.||percent of donor NK cells||Full Range|Median
166473|NCT00187096|Secondary|Percent of Peak NK Cell Chimerism|The maximum percent of donor NK cell in recipients during a four-week period after NK cell infusion.|Days 2, 7, 14, 21 and 28 after NK cell transplantation|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.||percent of NK cells||Full Range|Median
166474|NCT00187096|Secondary|Duration of Engraftment of Natural Killer (NK) Cells|NK cell engraftment defined as NK cell chimerism in recipients.|Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated|Arm 2 participants were not analyzed for this outcome as many of these patients proceeded to allogeneic stem cell transplantation following NK cell transplantation.||Days||Full Range|Median
166475|NCT00187096|Primary|Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the proportion of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.||proportion of patients|||Number
166476|NCT00187096|Primary|Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant|Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.|Beginning at on therapy through 100 days post-transplant|Grade 3 and 4 toxicities were assessed using Common Toxicity Criteria V.3.0 The assessment period was from the date on therapy through 100 days post-transplant.||participants|||Number
166477|NCT00186901|Secondary|To Investigate Possible Risk Factors (Bsm1 Vitamin D Receptor) for the Development of Diminished BMD in Patients Treated With Contemporary Protocol-based Therapy for Childhood ALL|The Bsm1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Bsm 1 vitamin D receptor, only 41 had the BB genotype, 65 had the Bb genotype, and 77 had the bb genotype.||QCT Z-Score||Standard Deviation|Mean
166478|NCT00186901|Secondary|To Investigate Possible Risk Factors (Apa1 Vitamin D Receptor) for the Development of Diminished BMD in Patients Treated With Contemporary Protocol-based Therapy for Childhood ALL|The Apa1 Vitamin D Receptor has been associated with bone mineral density and bone turnover markers in various patient cohorts but has not been investigated I survivors of childhood|At enrollment|Of the 424 patients screened, 417 participants consented for genetic testing. Of the 417 patients screened for the Apa 1 vitamin D receptor, only 68 had the AA genotype, 104 had the Aa genotype, and 49 had the aa genotype.||QCT Z-Score||Standard Deviation|Mean
166479|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 180 patients were assessed at 36 months by the QCT method and 89 were evaluated using the DXA methods to assess Bone Mineral Density. 89 patients received both scans.|36 months|180 patients were assessed at the 36 months interval and received a QCT Scan. 89 patients were also assessed using the DEXA Scan. Comparison of the two methods produced 89 paired studies to arrive at a correlation.||Z-score||Standard Deviation|Median
166480|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 188 patients were assessed at 24 months by the QCT method and 90 were evaluated using the DXA methods to assess Bone Mineral Density. 90 patients received both scans.|24 months|188 patients were assessed at the 24 months interval and received a QCT Scan. 90 patients were also assessed using the DXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation.||Z-score||Standard Deviation|Mean
166481|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 218 patients were assessed at 12 months for QCT. 94 were evaluated using DXA. 94 patients received both scans.|12 months|218 patients were assessed at the 12 months interval and received a QCT Scan. 94 patients were also assessed using the DXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation.||Z-score||Standard Deviation|Mean
166482|NCT00186901|Secondary|Quantitative Computed Tomography (QCT) and Dual Energy X-ray Absorptiometry (DXA) Scan Scores for Bone Mineral Density.|To compare the bone mineral density scores determined by Quantitative Computed Tomography (QCT) with those determined by dual energy x-ray absorptiometry (DXA) scan. 121 patients at baseline were assessed by both method the QCT and DXA methods to assess Bone Mineral Density.|Baseline|275 patients were assessed at baseline and received a QCT Scan. 121 patients were also assessed using the DEXA Scan. Comparison of the two methods used 121 paired studies to arrive at a correlation coefficient.||Z-score||Standard Deviation|Mean
166483|NCT00186901|Primary|Bone Mineral Density by Age Group of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (age groups) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether age was a contributing factor in bone mineral density.||Z-score||Standard Error|Median
166484|NCT00186901|Primary|Bone Mineral Density by Race of ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (race) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Assess baseline participants to determine whether race contributed to bone mineral density.||Z-score||Standard Error|Median
166485|NCT00186901|Primary|Bone Mineral Density in Male and Female ALL Survivors|Using bone mineral density Z-score, assess relationship between predisposing factors (gender) and bone mineral density; a negative value indicates a deficit in bone mineral density.|Baseline|Baseline participants were assessed to determine whether gender was a pre-disposing factor for bone mineral density.||Z-score||Standard Error|Median
166486|NCT00186901|Primary|Effect of Taking Calcium and Vitamin D Supplements on Bone Mineral Density (BMD)|The effect of taking calcium and vitamin D supplements was measured using Quantitative Computed Tomography (QCT) to calculate a QTC Z score. A standardized Z-score was calculated to indicate the difference between the patient’s Bone Mineral Density (BMD) and the mean value for age and gender-appropriate controls. Z-scores from 0 to +2 are considered normal, above +2 are considered to be elevated, from 0 to -1 are considered to represent a mild BMD deficit, between -1 and -2 are considered to represent moderate deficits, and below -2 are considered to represent severe deficits.|Baseline|275 pts were identified with BMD z-scores < 0. 134 were randomized to the placebo group and 141 to the supplement group. Bone Mineral Density QCT Z-scores were calculated at baseline, 12 months, 24 months, and at 36 months or study end.||Z-Score||Full Range|Median
166487|NCT00186888|Secondary|Assessment of School Readiness|The Bracken Basic Concepts Scale was used to assess school readiness. It is an examiner-administered measure that assesses per-academic skills including letter and number recognition, shapes, colors, and understanding of sizes and comparisons. Raw scores are converted into age-normed scaled scores (normative mean = 10, SD = 3) for the School Readiness Composite. Higher scores are indicative of stronger pre-academic skills, with scores from 7 to 13 within the Average range.|Patients were assessed at 5 years of age|All patients were included, regardless of treatment strata.||units on a scale||Standard Deviation|Mean
166488|NCT00186888|Secondary|Change in Parenting Stress Index (PSI)|The PSI is a commonly used measure of parenting stress. In 101 questions, the PSI delineates between stress as a function of child characteristics (e.g., adaptability, demandingness, mood; Child Domain) and stress as a function of parent characteristics (e.g., depression, sense of competence, social isolation; Parent Domain), as well as an overall stress score (Total Stress). Raw scores are calculated (normative means: Child Doman = 98.4; Parent Domain = 122.7; Total Stress Score = 221.1). This measure was given at all time points. Scores range from 131-320 for Total Stress, 69-188 for Parent Domain, and 50-145 for Child Domain, with higher scores indicative of greater stress (Total: >260; Parent: >153, Child: >122).|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
166489|NCT00186888|Secondary|Change in Parent Report of Social-Emotional Factors|This outcome was measured using the Ages and Stages Questionnaire which is a parent-completed measure of a child's social-emotional functioning. Raw scores are calculated and compared to cut-off points by age (6 months = 45; 1 year = 48; 2 years = 50; 3 years = 59; 5 years =70). Higher scores are indicative of more problems with scores above the cut-off indicating significant concerns warranting additional follow-up. Possible scores range from 0 to 200+, depending on the number of items administered, which varies by the age of the child (19 to 33 items). However, the primary use of this tool is as a screener. Thus, typically, scores are interpreted as they compare to the identified cut-offs, with children who score above the cut-off referred for further evaluation. This measure was given at all time points.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
166490|NCT00186888|Post-Hoc|Number of Patients Recommended for and Utilizing Rehabilitation Services|"Participants were evaluated by Occupational Therapy at diagnosis, and at 3, 6, 9, and 12 months from diagnosis with a battery of standardized and non-standardized measures. Assessments including the Battelle Developmental Inventory, the Sensory Profile, the Oregon Project for Visually Impaired Preschoolers, Pediatric Evaluation of Disability Inventory, and the Greenspan Social Emotional Growth Scale were utilized for developing the participants plan of care and making referrals for services in the home community. Recommendations for rehabilitation services in the home community were made based on the results of the occupational therapists evaluation.~A subsequent review of February 2013 subgroup definitions resulted in the reclassification of evaluable participants and subgroups in May 2015. This reclassification applies to the data for this outcome only."|At diagnosis, and at 3, 6, 9, and 12 months from diagnosis|Objective was added after the protocol started. Due to the late start, 33 of the 105 overall participants were eligible. Of the 33, 1 family declined to participate; 1 was removed from the protocol, 5 were lost to follow-up, and 4 patients were unable to complete the developmental assessment. In total, 22 have complete data sets.||participants|||Number
166519|NCT00185692|Secondary|Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant|GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant.|90 days|||Participants|||Count of Participants
166491|NCT00186888|Secondary|Change in Relevant Daily Living Skills|The Adaptive Behavior composite was measured using the Vineland Scales of Adaptive Behavior (VABS) which is an examiner-administered semi-structured interview that assesses adaptive functioning from birth through adulthood. Subscales including motor skills, communication, socialization, and daily living skills combine into an overall adaptive behavior composite which is an age-normed standard score (normative mean = 100, SD = 15). This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
166492|NCT00186888|Secondary|Change in Cognitive Functioning|The Early Learning Composite was assessed with Mullen Scales of Early Learning, a measure of developmental functioning appropriate for use with children from birth through age 5. It is an examiner-administered instrument that uses toys, games, pictures, and other objects to elicit information about a child's language, fine and gross motor skills, and overall early learning capabilities. Raw scores are converted to an age-normed standard score (normative mean = 100, SD = 15) for the overall Early Learning Composite. This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range.|Baseline (at study entry) and at ages 6 months, 1 year, 2 years, 3 years and 5 years|Data was collected from 94 unique patients. All patients were included, regardless of treatment strata. If the patient age at study entry (baseline) was within the window of an identified time point, their information was included with that time point.||units on a scale||Standard Deviation|Mean
166493|NCT00186888|Secondary|Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma . The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.||probability|Participants|95% Confidence Interval|Number
166494|NCT00186888|Secondary|Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification|"To describe the 5-year event-free survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately"|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. Participants with bilateral disease may have one eye in each category.||probability|Participants|95% Confidence Interval|Number
166495|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed.For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.||probability|Participants|95% Confidence Interval|Number
166496|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification|"To describe the 5-year event-free survival of the eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability."|From date on-study to an event or last follow-up|For the 23 stratum A patients, 35 eyes (12 bilateral patients, 11 unilateral patients) with IC grouping were analyzed. For 26 Stratum B patients, 1 eye with up-front surgery was excluded from analysis. 51 eyes with IC grouping were analyzed. Participants with bilateral disease may have one eye in each category.||probability|Participants|95% Confidence Interval|Number
166497|NCT00186888|Secondary|Ocular Survival of Eyes of Stratum B Patients|"To estimate the 5-year ocular survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).||probability|Participants|95% Confidence Interval|Number
166523|NCT00185679|Primary|Neutrophil Engraftment|Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC > 0.5x10e9/L|30 days post-transplant|||participants|||Number
166498|NCT00186888|Secondary|Event-free Survival of Eyes of Stratum B Patients|"To estimate the 5-year event-free survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|The criteria considered eyes of all stratum B patients with R-E I-III (11 eyes in 11 patients).||probability|Participants|95% Confidence Interval|Number
166499|NCT00186888|Secondary|Ocular Survival of Stratum A Patients|"To estimate the 5-year ocular survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.||probability||95% Confidence Interval|Number
166500|NCT00186888|Secondary|Event-free Survival of Stratum A Patients|"To estimate the 5-year event-free survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|All 23 stratum A patients received VC treatment and focal therapy.||probability||95% Confidence Interval|Number
166501|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
166502|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of the eye of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
166503|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year ocular survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
166504|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Not Responding to Window Treatment|To estimate the 5-year event free survival of patients with advanced intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan window, with a combination of vincristine, carboplatin, etoposide, and periocular carboplatin, with intensive focal treatments.|From date on-study to an event or last follow-up|The study closed to enrollment early due to poor accrual, but it remains open to follow-up. Both patients who developed new lesions in one eye during window therapy had a good response in the contralateral eye, and they continued on protocol therapy with vincristine/topotecan. Therefore, no patients were treated with this combination therapy.|||||
166505|NCT00186888|Secondary|Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival of eye will be defined per eye as the time interval from date on study to date of enucleation or date of last follow-up. Ocular survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.||probability|Participants|95% Confidence Interval|Number
166514|NCT00186875|Primary|Response Rate|"The response rate is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology."|End of re-induction Block C (approximately 1 month after the start of therapy)|Response is defined as morphological complete remission after re-induction Block C. Participants who begin re-induction phase but fail to reach the end of Block C for whatever reason will be regarded as an induction failure.||proportion of participants|||Number
166515|NCT00186537|Primary|Pre- and Post-Intervention HDL Cholesterol Levels|Compare the change in mean HDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|HDL Cholesterol||mg/dL||Standard Deviation|Mean
166516|NCT00186537|Primary|Pre- and Post-Intervention LDL Cholesterol Levels|Compare the change in mean LDL Cholesterol levels between groups after the interventions|Baseline, 12 weeks|LDL cholesterol||mg/dL||Standard Deviation|Mean
166506|NCT00186888|Secondary|Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free survival (EFS) of eyes of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year EFS."|From date on-study to an event or last follow-up|Of the 52 eyes (26 evaluable patients), 2 eyes (2 patients) were removed from analysis as they were not responsive to window therapy. In both cases, the contralateral eye was included in the analysis. One patient with upfront enucleation had only one eye for analysis. Eleven eyes were R-E Group I-III and were excluded. Total: 38 eyes for analysis.||probability|Participants|95% Confidence Interval|Number
166507|NCT00186888|Secondary|Ocular Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year ocular survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival"|From date on-study to an event or last follow-up|From the total of 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Thus, the Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.||probability||95% Confidence Interval|Number
166508|NCT00186888|Secondary|Event-free Survival of Stratum B Patients Responding to Window Treatment|"To estimate the 5-year event-free (EFS) survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier."|From date on-study to an event or last follow-up|Of the total 27 eligible patients in stratum B, 3 patients were not responding to the window therapy; 1 withdrew the consent and was taken off the study, and 2 developed disease progression. Kaplan and Meier estimate of ocular survival was calculated for the remaining 24 patients.||probability||95% Confidence Interval|Number
166509|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.~Only wild-type was present in BCRP 15994, therefore, statistical analysis was not done for these alleles."||Liters/hour/m^2||95% Confidence Interval|Median
166510|NCT00186888|Secondary|Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants.|Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol.|Courses 1, 2, 5, and 8|"Of the 107 participants enrolled in the overall study, analysis was performed for 19 participants who were enrolled on Stratum B AND who had results for both topotecan clearance and pharmacogenetic studies.~Only wild-type was present in CYP3A5*6, therefore, statistical analysis was not done for these alleles."||Liters/hour/m^2||95% Confidence Interval|Median
166511|NCT00186888|Secondary|Stratum B Response Rate of Early Stage Eyes to Window Therapy|To estimate the proportion of early stage eyes defined as Reese-Ellsworth Group I, II, or III eyes, that responded to 2 courses of window therapy which consisted of vincristine and topotecan|Six weeks post window therapy.|Among the 27 stratum B patients with 54 eyes with retinoblastoma, 12 eyes were early stage (Reese-Ellsworth group I, II, or III). The remaining 42 eyes were advanced stage and were not included in this analysis.||Participants|||Number
166512|NCT00186888|Primary|Stratum B Response to Window Therapy|The primary outcome is to estimate the proportion of stratum B patients responding to 2 courses of window therapy consisting of vincristine and topotecan. Complete Response is the complete regression of all apparent tumor masses in the funduscopic examination and by MRI and ultrasound (US). Partial Response is defined as greater than 50% (but less than 100%) reduction of the tumor masses in the funduscopic examination and by US and MRI, without the appearance of any new lesions. The response must persist for at least 4 weeks. Stratum A and C did not receive window therapy.|Six weeks post window therapy|The primary objective related to stratum B patients only, as these were the patients who were given window therapy consisting of 2 courses of vincristine and topotecan. Of the 27 stratum B patients enrolled, all were included in the analysis of the primary objective.||Participants|||Number
166513|NCT00186875|Primary|Overall Survival (OS)|OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate.|2 years after last patient completes therapy (approximately 4 years after enrollment)||||||
166517|NCT00186537|Primary|Pre- and Post-Intervention Triglyceride Levels|Compare the change in mean triglyceride levels between groups after the interventions|Baseline, 12 weeks|Triglycerides||mg/dL||Standard Deviation|Mean
166518|NCT00185965|Primary|Objective Response Rate (ORR)|Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)|12 weeks|||percentage of treated subjects|||Number
166524|NCT00185588|Secondary|Time-to-Progression, Evaluable Patients|Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.|12 months|"Evaluable subset of subjects that terminated from the study due to disease progression (endpoint).~No participants were analyzed in the Stage 1 Dose Exploration 2 - Gemcitabine 850 + Vatalanib 2 x 250 / 2 x 500 group because no evaluable participants progressed within 12 months."||months||Full Range|Median
166525|NCT00185588|Primary|Time-to-Treatment Failure (Intent-To-Treat Analysis)|"For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death.~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)."|12 months|||months||Full Range|Median
166526|NCT00185458|Secondary|Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166527|NCT00185458|Secondary|Progestogenic Symptom 7: Hair Loss (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166528|NCT00185458|Secondary|Climacteric Symptom 6: Breast Tension (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166529|NCT00185458|Secondary|Climacteric Symptom 5: Irritability (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166530|NCT00185458|Secondary|Climacteric Symptom 4: Sleep Problems (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166531|NCT00185458|Secondary|Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166532|NCT00185458|Secondary|Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166533|NCT00185458|Secondary|Climacteric Symptom 1: Hot Flushes (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166534|NCT00185458|Secondary|Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166535|NCT00185458|Secondary|Progestogenic Symptom 5: Edema (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166536|NCT00185458|Secondary|Progestogenic Symptom 4: Nausea (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166537|NCT00185458|Secondary|Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166538|NCT00185458|Secondary|Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS)|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166539|NCT00185458|Secondary|Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS))|Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166540|NCT00185458|Secondary|Continuation Rates|Percentage of subjects continuing in the study at the given time points.|At entry, at 2 years, at 4 years|ITT. Kaplan-Meier estimator given.||Percentage of participants continuing|||Number
166541|NCT00185458|Secondary|Assessment of QOL as Measured by Women's Health Questionnaire|Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced.|Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase|ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||score on a scale||Standard Deviation|Mean
166542|NCT00185458|Primary|Percentage of Participants With Successful Treatment|"Definition of successful treatment:~Completion of HRT phase, and~Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and~The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT"|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects eligible for the HRT||Percentage of participants with success|||Number
166543|NCT00185458|Primary|Number of Spotting Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in HRT Phase|ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||Spotting days||Inter-Quartile Range|Median
166544|NCT00185458|Primary|Number of Bleeding Days|Measured by using Subject Diaries (Subject Reported Data)|Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase|Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase.||Bleeding days||Inter-Quartile Range|Median
166545|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 12|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 991 to day 1080|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
166546|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 4|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 271 to day 360|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
166547|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 3|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 181 to day 270|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
166548|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 2|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 91 to day 180|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
166549|NCT00185380|Secondary|Bleeding Pattern by 90-day Reference Periods - Reference Period 1|Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.|day 1 to day 90|The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.||days||Standard Deviation|Mean
166550|NCT00185380|Secondary|Number of Subjects With Total or Partial Expulsions|The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.|Up to 3 years|The analysis was performed on the FAS (all subjects who had an IUS inserted).||participants|||Number
166551|NCT00185380|Primary|Pearl Index|The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.|Up to 3 years|All randomized women with a successful insertion were analyzed according to the treatment actually received and were included in the FAS, which was the set used for all safety and efficacy analyses. The PPS was identical to the FAS.||Number per 100 women years||95% Confidence Interval|Median
166552|NCT00185211|Secondary|MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60|Two-timepoint percentage brain volume change was estimated with Structural Image Evaluation, using Normalisation, of Atrophy (SIENA) software. The measurements describe the percentage change from screening in brain volume at month 60.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available. There were several missing values in both treatment arms regarding the percentage brain volume change.||Percentage of brain volume||Inter-Quartile Range|Median
166553|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60|Absolute change of volume of black holes from screening MRI to month 60 was calculated as volume of black holes at month 60 minus volume of black holes at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.||cubic millimeter||Inter-Quartile Range|Median
166554|NCT00185211|Secondary|MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60|Absolute change of T2 lesion volume from screening MRI to month 60 was calculated as T2 lesion volume at month 60 minus T2 lesion volume at screening.|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MRI scan readings at month 60 available.||cubic millimeter||Inter-Quartile Range|Median
166555|NCT00185211|Secondary|MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60|Newly active lesions are defined as displaying either new Gadolinium (Gd)-enhancement on T1-weighted scans or non-enhancement on T1-weighted scan but new on T2-weighted scan. The numbers of newly active lesions on yearly MRI scans were summed up to the cumulative number.|up to 60 months after start of treatment|The analysis followed the ITT principle. Not all patients in the full analysis set completed the follow-up study or had MRI scan readings at month 60 available.||cumulative number of lesions||Inter-Quartile Range|Median
166556|NCT00185211|Secondary|Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60|"The MSFC score consists of three sub-tests (Timed-25-Foot-Walk, 9-Hole-Peg-Test, 3 Paced Auditory Serial Addition Test [PASAT]). Standardized results (Z-scores) of the sub-tests and the overall MSFC Z-score as an average of the three Z-scores were derived using baseline data pooled over both treatment arms as reference population. Higher Z-scores reflect a better neurological status."|60 months after start of treatment|The analysis followed the ITT principle. Not all FAS patients completed the follow-up study or had MSFC results at month 60 available.||Z-scores||Inter-Quartile Range|Median
166557|NCT00185211|Secondary|Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate|The annualized relapse rate is defined as total number of relapses up to month 60 divided by the total observation time (last clinical visit minus first day of study treatment administration plus 1 of all participants) in years.|up to 60 months after start of treatment|The analysis followed the ITT principle. For each treatment arm, the relapse rate is defined as total number of relapses up to month 60 divided by the total observation time in years.||number of relapses per patient and year||95% Confidence Interval|Mean
166558|NCT00185211|Secondary|Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses|A relapse was defined as the appearance of a new neurological abnormality or the reappearance of a neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The time to the onset of recurrent relapses was determined for each subject according to the counting process representation for recurrent events. Time to a relapse was right-censored if a relapse-risk period ended without relapse. Based on the Andersen-Gill model the hazard ratio for recurrent relapses was estimated. Annualized relapse rates are provided as another outcome measure.|up to 60 months after start of treatment|The analysis followed the Intention-To-Treat (ITT) principle. The hazard for recurrent relapses was modelled by an extension of the Cox Proportional Hazards (PH) regression model (Andersen-Gill Model).||Ratio|||Number
166559|NCT00185211|Secondary|Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria|MS according to the criteria by McDonald was reached if, in addition to the single clinical demyelinating event, both dissemination in space and dissemination in time were established by MRI-criteria or a new relapse. Time to McDonald MS is the difference of date of McDonald MS to the date of Day 1 + 1. For subjects without McDonald MS, time to McDonald MS is the difference from the maximum (date of last magnetic resonance imaging scan, date of last clinical visit) to the date of Day 1 + 1 (right-censored observation).|up to 60 months after start of treatment|The analysis followed the ITT principle. After five years, in the initial placebo arm 151 participants and in the initial IFNB-1b arm 224 participants had reached McDonald MS diagnosis.||months||95% Confidence Interval|Median
166560|NCT00185211|Primary|Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60|As an index of health related quality of life in people diagnosed with MS, the FAMS Trial Outcome Index covers overall physical health (sum of sub-scale scores Mobility, Symptoms, Thinking/Fatigue, Additional Concerns) with a score range from 0 to 148. A higher score reflects a higher overall physical health as reported by patients.|60 months after start of treatment|The analysis followed the ITT principle. Not all patients who completed the follow-up study could be included at month 60 as subject to copyright constraints and to the availability of validated language versions, FAMS assessments could not be conducted in all patients.||units on a scale||Inter-Quartile Range|Median
166561|NCT00185211|Primary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time|"EDSS progression was defined as an increase in the expanded disability status scale (EDSS) of 1.0 point compared to the lowest EDSS score obtained during the screening or baseline visit, if this score was &lt;= 5.5. A confirmed EDSS progression status was defined as an EDSS progression observed at two consecutive scheduled visits at least 140 days apart from each other. The EDSS scale is a method of quantifying disability in multiple sclerosis in eight functional systems and values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on a scale."|up to 60 months after start of treatment|The analysis followed the ITT principle. The 25%-percentile for time to confirmed EDSS progression was 908 days in the initial placebo arm but was not estimable in the initial IFNB-1b arm. After five years, in the initial placebo arm 47 participants and in the initial IFNB-1b arm 65 participants had reached confirmed EDSS progression.||percentage of particip. with EDSS progr.|||Number
166594|NCT00184054|Primary|Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi)|Complete Remission (CR): ANC >=1000/mcl, Platelet count >=100,000/mcl, Bone marrow <5% blasts. Complete Remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Patients who failed to achieve CR or CRi after two cycles were considered treatment failures. Patients who did not complete at least two cycles were not evaluated for response.|Up to 1 year|All subjects who received at least 2 cycles of treatment as part of this study are included in the analysis of response.||participants|||Number
166562|NCT00185211|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time|"CDMS could be reached due to a qualifying relapse or sustained progression of 1.5 points on the expanded disability status scale (EDSS) as compared to the lowest EDSS obtained during screening or Day 1. The validity of CDMS diagnoses was confirmed by a central committee. The EDSS scale quantifies disability in MS in 8 functional systems, values vary between 0=normal neurological examination and 10=death due to MS measured in half-points on an ordinal scale. Time to CDMS = date of CDMS - date of Day 1 + 1 or time to CDMS = date of last clinical visit - date of Day 1 + 1 (right-censored)"|up to 60 months after start of treatment|The analysis followed the intention to treat (ITT) principle. After five years, in the initial placebo arm 94 participants and in the initial IFNB-1b arm 124 participants had reached CDMS diagnosis.||cum. percentage of particip. with CDMS|||Number
166563|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 4 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-208|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Subjects|||Number
166564|NCT00184717|Secondary|Adverse Events - Subjects Received NN220 Treatment for 5 Years|Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly|Weeks 0-260|Safety analysis set consisted of all subjects who received at least one dose of NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Subjects|||Number
166565|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52*i weeks – Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||years||Standard Deviation|Mean
166566|NCT00184717|Secondary|Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52*i weeks – Bone age at 52*(i-1) weeks, i=1, 2, ….|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||years||Standard Deviation|Mean
166567|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Deviation|Mean
166568|NCT00184717|Secondary|Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years|Yearly Height velocity SDS for chronological age were summarised and graphically presented|Weeks 0-260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Deviation|Mean
166569|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years|Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 208|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
166570|NCT00184717|Primary|Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years|Height SDS for chronological age were derived as follow; {Height – mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit|Week 0, week 260|Endpoint Analysis Set (EAS) consisted of subjects who participated in GHLIQUID-1517 in the Full Analysis Set (FAS). FAS consisted of subjects who were randomised in each group and have any available efficacy data after receiving NN-220 in GHLIQUID-1516 or GHLIQUID-1517, except subjects with GCP (Good Clinical Practice) nonconformity||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
166571|NCT00184600|Secondary|Number of Participants Having an 'Other' Adverse Event||Up to month 37 (36 months of treatment plus 1 month follow-up)|Safety population consisting of all randomised participants exposed to at least one dose of trial drug(s).||participants|||Number
167483|NCT00165698|Secondary|Bone Biomarker Osteocalcin (OC) Percentage Change After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of OC||Inter-Quartile Range|Median
166572|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||units on a scale||95% Confidence Interval|Mean
166573|NCT00184600|Secondary|Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months|The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||units on a scale||95% Confidence Interval|Mean
166574|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||mg/dL||Standard Deviation|Mean
166575|NCT00184600|Secondary|Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months|For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.|Baseline, month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||mg/dL||Standard Deviation|Mean
166576|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 36||Week 0 (baseline), month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||kilograms||Standard Deviation|Mean
166577|NCT00184600|Secondary|Change From Baseline in Body Weight at Month 12||Week 0 (baseline), month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||kilogram||Standard Deviation|Mean
166578|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 36|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
166579|NCT00184600|Secondary|Percentage of Participants Who Required A Second Insulin Therapy by Month 12|Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
166580|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
166595|NCT00184028|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|At end of every cycle|All participants who started treatment||Participants|||Number
166581|NCT00184600|Secondary|Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%|Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||hypoglycaemic events/participant/year||Inter-Quartile Range|Median
166582|NCT00184600|Secondary|Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%|Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36|Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
166583|NCT00184600|Secondary|Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%|Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.|Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage of participants|||Number
166584|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 36|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 36|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage (%) of total haemoglobin||Standard Deviation|Mean
166585|NCT00184600|Primary|HbA1c (Glycosylated Haemoglobin) at Month 12|HbA1c values offer evidence of the efficacy and durability of the insulin regimens.|Baseline, Month 12|Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.||percentage (%) of total haemoglobin||Standard Deviation|Mean
166586|NCT00184548|Secondary|Number of Units of All Allogeneic Transfusions From Time of First Dose|The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set, including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.||Units of allogeneic transfusions||Standard Deviation|Mean
166587|NCT00184548|Secondary|Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury|The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.||Participants|||Number
166588|NCT00184548|Secondary|Number of Units of Transfused Red Blood Cells From Time of First Dose|The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.|from hour 0 to 24|Blunt trauma patient population: Intention-to-treat (ITT) analysis set including patients who discontinued before day 30. Penetrating Trauma patient population: No analysis done due to low statistical power.||Units of transfused red blood cells||Standard Deviation|Mean
166589|NCT00184548|Secondary|Time to Death From Time of First Dose|The time of first dose refers to the time of the first dose of rFVIIa or placebo.|from day 0 to day 30|There is no measure summary for time to event type of endpoint as this would be a Kaplan-Meier graph.|||||
166590|NCT00184548|Secondary|Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention|The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.|from day 0 to day 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Penetrating Trauma patient population: No analysis done due to low statistical power.||Days||Standard Deviation|Mean
166591|NCT00184548|Primary|Morbidity|Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.|from day 0 to day 30|Blunt trauma patient population: According to protocol, morbidity is not part of the primary endpoint since non-inferiority test of mortality was not passed. Penetrating Trauma patient population: No analysis done due to low statistical power.|||||
166592|NCT00184548|Primary|Mortality|Number of participants to die from day 0 to day 30 from all causes.|from day 0 to 30|Blunt trauma patient population: Intention-to-treat (ITT) analysis set. Patients who discontinued (withdrawn or lost to follow up) before day 30 were excluded from analyses. Penetrating Trauma patient population: No analysis done due to low statistical power.||Participants|||Number
166593|NCT00184054|Secondary|Number of Participants With Severe (Grades 3-5) Adverse Events|Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses.|Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy)|||Participants|||Number
166596|NCT00184028|Primary|Tumor Response|"All eligible patients who received the first dose of Taxotere will be included in the analysis.~Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease.~Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 months after the last subject enrolled has gone off study|||Participants|||Number
166597|NCT00183963|Secondary|Number of Participants With Changes in Mammographic Density|The mammograms will be scanned and a validated computer based threshold method will be used to determine the mammographic densities.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject accrued on to each of the treatment arms.|||||
166598|NCT00183963|Primary|Number of Participants With Molecular Changes in Markers of Cell Proliferation and Apoptosis Associated With Treatment|Molecular measures of effect will be measured in tissue obtained at baseline biopsy (paraffin specimen) and on surgical specimen obtained at end of 3 weeks of treatment.|6 months after treatment of last patient enrolled|Analysis was not conducted since there was only 1 subject randomized on to each of the treatment arms.|||||
166599|NCT00183794|Secondary|Median Time to Progression (Months)|Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression based on RECIST v1.0 criteria for measurable disease, and on CA-125 for patients with an elevated CA-125 as the only evidence of disease (Rustin et al. JCO 14:1545-51, 1996)|6 months after enrollment of last patient|All participants who receive the first course of treatment are included in the summary of PFS.||Months||Full Range|Median
166600|NCT00183794|Primary|Tumor Response Type: CR, PR, SD or PD|Tumor response will be based on the RECIST v1.0 criteria. CR (complete response)= disappearance of all target lesions, PR (partial response)= greater or equal to 30% decrease in sum of longest diameter of target lesions, SD (stable disease)= <30% decrease or <20% increase, PD (progressive disease)= greater or equal to 20% increase in longest diameter of target lesions. For patients with an elevated CA-125 as the only evidence of disease, a PR was defined as a decrease of 50% or more lasting at least 8 weeks (Rustin et al. JCO 14:1545-51, 1996). Disease assessment performed every 2 cycles (1 cycle = 21 days). Responders included CR and PR.|6 months after enrollment of last participant|Participants with evaluable or measurable tumor, who complete 2 courses of treatment will be included in analysis of tumor response.||Participants|||Number
166601|NCT00183729|Secondary|Functional Recovery||Measured at Week 12||||||
166602|NCT00183729|Secondary|Incidence of Major Depressive Disorder||Measured at Week 12||||||
166603|NCT00183729|Primary|Depressive Symptoms|Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)|Measured at Week 12|||units on a scale||Standard Deviation|Mean
166604|NCT00183677|Primary|Responder and Remission Status (%), Based on the Depression Rating Scale Score|The Hamilton Depression Rating Scale, 17 items (HAMD-17, range 0-52) was used to measure changes in depression severity from baseline to endpoint. Clinical Responder status was defined as > 50% improvement (i.e., reduction) in HAMD-17 score from baseline to endpoint. Clinical Remission status was defined as HAMD-17 score < 8 at endpoint (week 12 visit).|Measured at Week 12|97 patients with MDD (42 Female) enrolled in the 12 week study, 53 patients (27 Female) completed. Only completers were included in the primary outcome measure.||participants|||Number
166605|NCT00183625|Secondary|Body Mass Index|Intent was to compare medication and not work group conditions. This was initially assessed at baseline and includes total time on either risperidone or olanzapine up to 18 months.|First 18 months of study|||kg/m^2||Standard Error|Least Squares Mean
166606|NCT00183625|Primary|Total Weeks Worked||24 months|Data were analyzed for work condition (IPS with or without WIPS) and not for medication (risperidone or olanzapine)||Weeks||Standard Deviation|Mean
166607|NCT00183469|Primary|Mania Rating Scale|Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.|up to 8 months|all randomized subjects||units on a scale||Standard Error|Mean
166608|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||18 months|||participants|||Number
166609|NCT00183456|Primary|Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)||18 months|||participants|||Number
166610|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)||18 months|||participants|||Number
166611|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)||18 months|||participants|||Number
166612|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)||18 months|||participants|||Number
166613|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)||18 month|||participants|||Number
166614|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||12 months|||participants|||Number
166615|NCT00183456|Primary|Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)||12 months|||participants|||Number
166616|NCT00183456|Secondary|HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)||6 months|||participants|||Number
166617|NCT00183456|Primary|Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)|Number of participants that had 2 or more sex partners in the past 90 days.|6 months|||participants|||Number
166618|NCT00183430|Secondary|Measures of Nightmare Frequency, Depressive Signs and Symptoms, Quality of Life, and Number of Study Days Completed||Measured at Weeks 4 and 8 post-treatment||||||
166619|NCT00183430|Secondary|"CAPS Subscale Scores (Reexperiencing/Intrusions, Avoidance/Numbing, and Hyperarousal)"||Measured at Weeks 4 and 8 post-treatment||||||
166620|NCT00183430|Secondary|Total CAPS Score||Measured at Weeks 4 and 8 post-treatment||||||
166681|NCT00181155|Secondary|Cardiac PCr/ATP Post Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.||ratio||Standard Deviation|Mean
166621|NCT00183430|Primary|Change in Sleep Assessed by the Pittsburgh Sleep Quality Index|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.||Units on a Scale||Standard Deviation|Mean
166622|NCT00183430|Primary|Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS|"Item B-2 recurrent distressing dreams of the event is a single item from teh Clinician Administered PTSD Scale (CAPS). The rating consists of two parts: Frequency plus Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. The total minimum score = zero. The total maximum score = 8. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 8."|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 4.||Units on a Scale||Standard Deviation|Mean
166623|NCT00183430|Primary|Clinical Global Impression of Change|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The Clinical Global Impression of Change is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from Baseline to Week 8.|Baseline to Week 8|Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.||Units on a Scale||Standard Deviation|Mean
166624|NCT00183339|Secondary|Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)|The Aberrant Behavior Checklist (ABC) is a caregiver completed rating scale that assesses problem behaviors frequently seen in individuals with developmental disabilities. There are a total of 58 items on 5 subscales that are rated from 0 - not at all a problem to 3 - problem is severe in degree. The ABC-I consists of 15 items that reflect mood swings, self-injury and aggression. The subscale score is the sum of the score on each of the 15 items. The minimum score on the ABC-I is 0 and the maximum score is 45. Higher scores reflect more severe behavioral problems. A score > or = to 18 is generally considered clinically significant.|12 months|||units on a scale||Standard Deviation|Mean
166625|NCT00183339|Secondary|Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire|This is a caregiver completed measure that assesses the extent to which the caregiver feels care of the participant influences the caregiver's and other family members' emotional states and/or activities. There are a total of 22 items rated from 1 - not at all to 5 - very much (with one item reverse scored). Total score is the sum of all the items (with one item reverse scored). There are three subscales objective strain -12 items, internalized subjective strain 6 items, externalized subjective 4 items. The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.|12 months|||units on a scale||Standard Deviation|Mean
166626|NCT00183339|Secondary|Rate of Attrition|The percentage of participants who discontinued treatment prior to completion of the 12 month study|Measured at Month 12|||percent of group that discontinued early|||Number
166627|NCT00183339|Primary|Rate of Recruitment|In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment* 2sites ) /[ # participants randomized ] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.|19 months|||months/participant at 1 site|||Number
166628|NCT00183274|Secondary|Clinical Global Impressions, Severity of Illness|"The CGI provides an overall clinician-determined summary measure that takes into account a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.~The CGI is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~Results of the Placebo After Placebo group in Phase 3 were not entered due to sample size limitations."|Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse)|The primary efficacy analytic method was time to relapse analyses estimated using a discrete time Cox proportional hazards model.Chisquare analyses were used to contrast relapse or responder rates. In the case of small cell sizes, Fisher exact test replaced chisquare analysis.||Severity Score||Standard Deviation|Mean
166629|NCT00183274|Primary|Hamilton Rating Scale for Anxiety|"Hamilton Rating Scale for Anxiety - The assessment of anxiety states by rating~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)|The primary efficacy analytic method was time-to-relapse analyses estimated using a discrete-time Cox proportional hazards model.||HAM-A Rating Score||Standard Deviation|Mean
166630|NCT00183248|Secondary|Number of Graft-versus-host Disease (GVHD) Events|A disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. Also called graft-versus-host disease.|Three years post kidney transplant|Intent-to-Treat||GVHD Events|||Number
166631|NCT00183248|Secondary|Number of Chronic Allograft Nephropathies|"Number of chronic allograft nephropathies[1,2,3] at 3 years post kidney transplant.~Chronic allograft nephropathy is defined as renal biopsies with Banff 97 Grade I or greater[2] with higher numeric scores indicating more severe nephropathy~The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification[3]~Reference: Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced nephropathies||Nephropathy Events|||Number
166876|NCT00176462|Secondary|To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis||5 years|We did not analyze this outcome measure. The laboratory analysis was not performed. The Principal Investigator left the institution.|||||
166632|NCT00183248|Secondary|Number of Kidney Biopsy-proven Acute Rejection|"Biopsy-proven acute renal (kidney) rejection[1,2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Three years post kidney transplant|Participants who experienced an acute rejection||Rejection Events|||Number
166633|NCT00183248|Secondary|Graft Survival at Three Years Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at three years post-transplant~[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|Three years post kidney transplant|Intent-to-Treat||participants|||Number
166634|NCT00183248|Secondary|Participant Survival at Three Years Post Kidney Transplant||Three years post kidney transplant|Intent-to-Treat||participants|||Number
166635|NCT00183248|Primary|Overall Kidney Graft Survival at One Year Post-Transplant|"Number of participants that did not experience kidney graft failure[1] at one year post-transplant~[1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation."|One year post kidney transplant|Intent-to-treat||participants|||Number
166636|NCT00183248|Primary|Overall Participant Survival at One Year Post Kidney Transplant||One year post kidney transplant|Intent-to-Treat||participants|||Number
166637|NCT00183196|Primary|Time to Relapse to Drinking|Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol.|16 weeks|||days||Standard Error|Mean
166638|NCT00183092|Secondary|Change in Semantic Verbal Fluency (Naming Animals)|Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (naming animals) is semantic. Higher scores indicate better cognition.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at month 2 visit.||number of words generated||Full Range|Mean
166639|NCT00183092|Secondary|"Change in Phonemic Fluency (Words Beginning With Letter D)"|"Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (words beginning with letter D) is phonemic. Higher scores indicate better cognition."|Baseline, 2 months|Subject still alive and able to tolerate cognitive testing at month 2 visit||number of words generated||Full Range|Mean
166640|NCT00183092|Secondary|ADAS-Cog Change After 2 Months Among Survivors|ADAS-cog measures cognitive performance by combining ratings of 11 components (word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering instruction, spoken language, word finding, comprehension) representing six areas of cognition: memory; language; orientation to time, place and person; construction of simple designs and planning; and performing simple behaviors in pursuit of a basic, predefined goal. Seven components are scored as the ‘number incorrect’. For example, in the commands component, the number of five commands performed incorrectly (range: 0-5). Four components are scored from 0 (no limitations) to 5 (max limitations) as the examiner's perception of remembering instructions, spoken language ability, word finding and comprehension. Component scores are summed into a total ADAS-cog score ranging from 0-75, with low scores indicating better cognitive performance.|Baseline, 2 months|Subjects still alive and able to tolerate cognitive testing at Month 2 visit.||units on a scale||Full Range|Mean
166641|NCT00183092|Secondary|Change in Rankin Score After 2 Months|"The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead. For subjects unable to return for the 2-month visit, Rankin score was assessed via telephone."|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone||units on a scale||Full Range|Mean
166642|NCT00183092|Secondary|Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months|Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB). The CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The global CDR score is computed via an algorithm. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. A higher value and/or positive change is worse. For subjects unable to return for month-2 visit, CDRS-SB was performed via telephone.|Baseline, 2 months|For subjects still alive at month 2 and assessed at the 2-month visit or via telephone||units on a scale||Full Range|Mean
166643|NCT00183092|Secondary|Barthel Score Change After 2 Months|An ordinal scale used to measure performance in activities of daily living. Scores range from 0 (worst, fully dependent) to 100 (best, independent); higher score associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. 10 individual items are scored and summed to derive the overall Barthel index score. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The amount of time and physical assistance required to perform each item are considered in scoring each item. For subjects unable to return for month-2 visit, Barthel Index was performed via telephone.|baseline, 2 months|One surviving subject in the quinacrine arm did not attend the 2-month visit and was lost-to-followup; for a second surviving subject in the quinacrine arm, the Barthel Index was inadvertently not performed at the 2-month visit.||units on a scale||Full Range|Mean
166682|NCT00181155|Primary|Myocardial CK Flux Post Intravenous Allopurinol Infusion.|The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.|acute (within 15 minutes of single infusion)|Data were analyzed for all participants who completed the MRS per protocol.||umol/g/sec||Standard Deviation|Mean
166644|NCT00183092|Secondary|Change in Mini–Mental State Examination (MMSE) After 2 Months|The mini–mental state examination (MMSE) is a brief 30-point questionnaire that is used to screen for cognitive impairment. In about 10 minutes it samples functions including arithmetic, memory and orientation. A score greater than or equal to 25 points (out of 30) indicates a normal cognition. Lower scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment. Low to very low scores correlate closely with the presence of dementia, although other mental disorders can also lead to abnormal findings on MMSE testing.|Baseline to Month-2|Subjects still alive, who attended the month-2 visit and were willing and able to tolerate cognitive testing. 1 subject in each arm did attend the 2-month visit but did not cooperate fully with the MMSE, which was therefore not scored.||units on a scale||Full Range|Mean
166645|NCT00183092|Primary|Primary Survival|Participants alive after 2 months on study treatment|Randomization to Month-2|||participants|||Number
166646|NCT00182767|Primary|Maximum Tolerated Dose|The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details|Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD).|The phase I component of the study included 30 patients with breast and ovarian cancer.||mg/m2|||Number
166647|NCT00182767|Secondary|Progression-free Survival|We will summarize progression-free survival by Kaplan-Meier survival analysis.|The time from start of treatment to time of progression or death, assessed up to 2 years|||months||95% Confidence Interval|Median
166648|NCT00182767|Secondary|Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II)||Up to 2 years|||participants|||Number
166649|NCT00182767|Primary|Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I)|Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities|28 days|||participants|||Number
166650|NCT00182689|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0 - 2 years|||months||95% Confidence Interval|Median
166651|NCT00182689|Primary|Objective Response (Confirmed and Unconfirmed, Complete and Partial Responses Per RECIST)|Complete Response (CR) is a complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|8 weeks to 2 years|All eligible patients who received treatment were included in this measure.||percentage of participants||95% Confidence Interval|Number
166652|NCT00182689|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after completion of every 28-day cycle.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
166653|NCT00182637|Secondary|Toxicity||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.|||||
166654|NCT00182637|Secondary|Time to Progression||2 years|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.|||||
166655|NCT00182637|Primary|Overall Response Rate After 2 Courses of Treatment||2 months|Only two subjects completed the trial. Study closed early due to lack of enrollment. No analysis performed.|||||
166656|NCT00182091|Secondary|Change in Visceral Abdominal Adipose Tissue|Change in visceral abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||millimeters squared||Standard Deviation|Mean
166657|NCT00182091|Secondary|Change in Total Abdominal Adipose Tissue|Change in total abdominal adipose tissue in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||millimeters squared||Standard Deviation|Mean
166658|NCT00182091|Secondary|Change in Total Fat Mass|Change in total fat mass in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||kilograms||Standard Deviation|Mean
166683|NCT00181155|Secondary|Cardiac PCr/ATP Pre Intravenous Infusion|The mean ratio of creatine phosphate (PCr) to ATP in the heart. This measure, as a ratio, is unitless.|Onset of image acquisition.|Data were analyzed for all participants who completed the MRS per protocol.||ratio||Standard Deviation|Mean
166659|NCT00182091|Primary|Change in High-sensitivity C-reactive Protein|Change in high-sensitivity C-reactive protein in the AcroGHD randomized to Growth Hormone and AcroGHD randomized to Placebo arms. Note that the AcroGHS and Active Acromegaly arms were not interventional arms and thus do not have outcome results.|baseline and 6 months|In the Growth Hormone group, 1 study participant did not complete the study due to discomfort at injection sites. In the Placebo group, data from one study participant was excluded from analysis due to initiation of appetite suppressants to induce weight loss during the study, as prescribed by a physician at a bariatric clinic.||mg/liter||Standard Deviation|Mean
166660|NCT00182078|Primary|Diagnostic Interview for Children and Adolescents (DICA) - Child|The DICA is a semi-structured interview, and was used to measure Post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to children who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.||units on a scale||Standard Deviation|Mean
166661|NCT00182078|Secondary|The Child Depression Inventory (CDI)|The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined.|Baseline to Week 12|Intention to treat (ITT). Analysis was conducted on participants with available data.||units on a scale||Standard Deviation|Mean
166662|NCT00182078|Primary|Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent|The DICA is a semi-structured interview, and was used to measure post Traumatic Stress Disorder (PTSD) symptoms in children. The DICA was administered to parents who were English-speaking. A minimum total score of 7 and a maximum total score of 18 is required to meet criteria for PTSD. A higher score is indicative of increased PTSD symptoms. Changes in scores from Baseline to Week 24 were examined.|Baseline to Week 24|Intention to treat (ITT). Analysis was conducted on participants with available data.||units on a scale||Standard Deviation|Mean
166663|NCT00182000|Secondary|Disability Inventory||Post-treatment (week 5)||||||
166664|NCT00182000|Secondary|Short-Form Health Survey (SF-36)||Post-treatment (week 5)||||||
166665|NCT00182000|Secondary|Obsessional Beliefs Questionnaire (OBQ)||Post-treatment (week 5)||||||
166666|NCT00182000|Secondary|Beck Anxiety Inventory (BAI)||Post-treatment (week 5)||||||
166667|NCT00182000|Secondary|Beck Depression Inventory (BDI)||Post-treatment (week 5)||||||
166668|NCT00182000|Secondary|Clinical Global Impressions Scale (CGI)||Post-treatment (week 5)||||||
166669|NCT00182000|Primary|Yale-Brown Obsessive Compulsive Scale (YBOCS)|A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).|Post-treatment (week 5)|Thirty-three participants were enrolled. Four participants decided not to participate in between enrolling and beginning treatment. Six participants withdrew from the study before the mid-treatment evaluation; 1 participant withdrew from the study after the mid-treatment evaluation, and this participant's data was carried forward.||units on a scale||Standard Deviation|Mean
166670|NCT00181883|Primary|Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score|The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60.|Baseline to 8 weeks|||Units on a scale||Standard Deviation|Mean
166671|NCT00181844|Primary|Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)|Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.|baseline to 12 weeks|||Units on a scale||Standard Deviation|Mean
166672|NCT00181766|Primary|The Adult AISRS|The Adult AISRS was used to assess each of the 18 individual criteria symptoms (both inattentive and hyperactive) of ADHD in DSMIV on a severity grid (0=not present; 3=severe; minimum score=0; maximum score=54). Results are given as average change (reduction) in AISRS symptoms from baseline to Week 6.|baseline and 6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule. Baseline and endpoint AISRS scores were compared used paired t-tests. Statistical significance was determined at alpha level 0.05.||scores on a scale||Standard Deviation|Mean
166673|NCT00181766|Primary|ADHD-Clinical Global Impression|The CGI includes Global Severity (1=not ill; 7=extremely ill) and the Global Improvement (1=very much improved; 7=very much worse) Scales. Overall severity and change in severity of ADHD was assessed with the Clinical Global Impression Scale (CGI). Improvement was defined by CGI-I ≤2, much or very much improved, at study endpoint. Results are given as number of subjects who improved according to the CGI-I using the definition above.|6 Weeks|All analyses were intention to treat (ITT) with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule.||subjects|||Number
166674|NCT00181714|Primary|Cigarette Smoking|Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)|24 months|Clinical trial subjects included in this analysis included those adolescents who took at least one dose of OROS MPH following baseline assessment (N=154), with the last observation carried forward (LOCF) for subjects who did not complete the full study schedule of 24 months||percent|||Number
166675|NCT00181623|Secondary|Breast Milk Prolactin Levels and Content|Treatment group|28 days||||||
166676|NCT00181623|Secondary|Breast Milk Volume|Treatment group|28 days||||||
166677|NCT00181623|Primary|Breast Milk Production|Treatment group|28 days|One subject did not qualify after screening.||mL/day||Standard Error|Mean
166678|NCT00181610|Secondary|Breast Milk Prolactin Levels and Content||7 days||||||
166679|NCT00181610|Secondary|Breast Milk Volume||7 days||||||
166680|NCT00181610|Primary|Breast Milk Production||7 days|||% change from baseline||Standard Error|Mean
166775|NCT00178711|Other Pre-specified|Controlled Oral Word Association Test||0-12 months||||||
166776|NCT00178711|Other Pre-specified|Grooved Pegboard||0-12 months||||||
166684|NCT00181155|Primary|Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion|Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion|Onset of imaging acquisition.|Data were analyzed for all participants who completed the MRS per protocol.||umol/g/sec||Standard Deviation|Mean
166685|NCT00180687|Secondary|Postoperative Morphine Use|The reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events|24 Hoiurs|||mg||Full Range|Mean
166686|NCT00180687|Secondary|Hours Needed for Safe Mobilization|Drowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.|24 Hours|||Hours needed for safe mobilization||Full Range|Mean
166687|NCT00180687|Secondary|Number of Vomiting / Nausea Episodes|Nausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.|24 hours|||Number of vomitting / Nausea episodes||Full Range|Mean
166688|NCT00180687|Primary|Reduction in Postoperative Pain|Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.|0 hours, 6 hours, 12 hours, 24 hours|||units on a scale||Full Range|Mean
166689|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166690|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166691|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166692|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|5 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166693|NCT00180479|Secondary|In-segment % Diameter Stenosis (% DS)|Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 – in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percent of in-segment diameter stenosis||Standard Deviation|Mean
166694|NCT00180479|Secondary|In-stent % Diameter Stenosis (% DS)|In-stent: Within the margins of the stent, the value calculated as 100 * (1 – in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percent diameter stenosis||Standard Deviation|Mean
166695|NCT00180479|Secondary|% Volume Obstruction (% VO)|Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percent of volume obstruction||Standard Deviation|Mean
166696|NCT00180479|Secondary|In-stent Late Loss|In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||millimeters||Standard Deviation|Mean
166777|NCT00178711|Other Pre-specified|Verbal Selective Reminding Test Trails B||0-12 months||||||
166697|NCT00180479|Secondary|Distal Late Loss|Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||millimeters||Standard Deviation|Mean
166698|NCT00180479|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||millimeters||Standard Deviation|Mean
166699|NCT00180479|Secondary|Acute Success: Clinical Procedure|Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital|||percentage of participants|||Number
166700|NCT00180479|Secondary|Acute Success: Clinical Device|Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.|In-hospital|||percentage of participants|||Number
166701|NCT00180479|Secondary|Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection|"Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.~Persisting dissection @ follow-up, present post-procedure."|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percentage of participants|||Number
166702|NCT00180479|Secondary|In-segment % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA|240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percentage of participants|||Number
166703|NCT00180479|Secondary|In-stent % Angiographic Binary Restenosis (% ABR) Rate|Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)|at 240 days|Only a certain number of patients were required to have angiographic or IVUS follow-up. The analysis population for these follow-ups may have changed due to patient's not completing an angiographic or IVUS follow-up procedure. Patients may also have missed the follow-up visits due to early termination from the study.||percentage of participants|||Number
166704|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166705|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166706|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event(MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166707|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166708|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166709|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166778|NCT00178711|Other Pre-specified|Rey Osterrieth Complex Figure||0-12 months||||||
166779|NCT00178711|Other Pre-specified|Symbol Digit Modalities Test||0-12 months||||||
166780|NCT00178711|Other Pre-specified|Neurological Outcome Scale for Traumatic Brain Injury||0-12 months||||||
166781|NCT00178711|Other Pre-specified|Neurobehavioral Rating Scale – Revised||0-12 months||||||
166710|NCT00180479|Secondary|Ischemia Driven Major Adverse Cardiac Event (MACE)|"The composite endpoint comprised of:~Cardiac death~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166711|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|4 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166712|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|3 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166713|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166714|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166715|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166716|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166717|NCT00180479|Secondary|Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization at the target vessel associated with any of the following~Positive functional ischemia study~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study~Derived from Non-Hierarchical Subject Counts of Adverse Events"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166718|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166719|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166782|NCT00178711|Other Pre-specified|Disability Rating Scale||assessed 0-12 months||||||
166720|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|2 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166721|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|1 years|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166722|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|270 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166723|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166724|NCT00180479|Secondary|Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization @ target lesion associated w/ any of following:~(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166725|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|4 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166726|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|3 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166727|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|2 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166728|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|1 year|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166729|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|180 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166730|NCT00180479|Secondary|Target Vessel Failure (TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|30 days|All patients in the study underwent clinical follow up to provide the information needed for the secondary endpoints. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.||percentage of participants|||Number
166731|NCT00180479|Secondary|Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)|"The composite endpoint comprised of:~Cardiac death (death in which a cardiac cause cannot be excluded)~Myocardial infarction (MI, classified as Q-wave and non-Q wave)~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI~Ischemia-driven target vessel revascularization (TVR) by CABG or PCI"|270 days|All patients in the study underwent clinical follow up to provide the information needed for this endpoint.||percentage of participants|||Number
166732|NCT00180479|Primary|Primary Endpoint: In-segment Late Loss (LL)|In-segment minimal lumen diameter (MLD) post-procedure minus (–) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.|240 days|Only a certain number of patients were required to have angiographic follow-up to provide this endpoint information.||millimeters||Standard Deviation|Mean
166733|NCT00180323|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up|implant (baseline), 3 Months, 6 Months|||% of cardiac volume||Standard Deviation|Mean
166734|NCT00180323|Secondary|6 Minute Walk Test|6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.|implant (baseline), 3 months and 6 months Follow-up|||meter||Standard Error|Mean
166735|NCT00180323|Primary|Optimal AV-Delay (AVD)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.|Implant (baseline), 3 months and 6 months Follow-up|||ms||Standard Deviation|Mean
166736|NCT00180323|Primary|Aortic Velocity Time Integral (VTI)|Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).|At implant (baseline), 3 months and 6 months Follow-up|||cm||Standard Deviation|Mean
166737|NCT00180271|Secondary|Recurrent Heart Failure Events||Time of event, DSMB review||||||
166738|NCT00180271|Primary|Mortality From Any Cause or First Heart Failure (HF) Event|"MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:~administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician’s office, etc.), or~administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay."|Outcome measured at average follow-up duration of 2.4 years.|Analysis was performed on an intention-to-treat basis.||Participants|||Number
166739|NCT00179959|Primary|Change in Eczema Area and Severity Index (EASI)Scores According to Location|The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician’s Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician’s Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).|Baseline and 3 months|Analysis was per protocol.||Change in EASI Score||Standard Deviation|Mean
166740|NCT00179673|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.~The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:~Grade 1 = Mild~Grade 2 = Moderate~Grade 3 = Severe~Grade 4 = Life threatening~Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.|Safety Population, which includes all participants who received at least one dose of study drug.||participants|||Number
166741|NCT00179673|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent to treat population||months||95% Confidence Interval|Median
166742|NCT00179673|Secondary|The Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Includes participants with a response to treatment||months||95% Confidence Interval|Median
166783|NCT00178711|Other Pre-specified|Glasgow Outcome Scale - Extended||0-12 months||||||
166784|NCT00178711|Primary|The Dichotomized Glasgow Outcome Scale|The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.|6 months with a window of plus or minus one month|Intention to Treat||participants with a poor outcome|||Number
166807|NCT00177970|Secondary|1) 75% Reduction in Abdominal Pain/Tenderness|During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166743|NCT00179673|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).~PD was defined as~≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.~Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders||percentage of participants||95% Confidence Interval|Number
166744|NCT00179673|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).~PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.||percentage of participants||95% Confidence Interval|Number
166745|NCT00179660|Secondary|Number of Participants With Adverse Events (AEs)|"The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event.~The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale:~Grade 1 = Mild~Grade 2 = Moderate~Grade 3 = Severe~Grade 4 = Life threatening~Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 15.2 months.|Safety Population, which includes all participants who received at least one dose of study drug.||participants|||Number
166746|NCT00179660|Secondary|Progression-free Survival|"Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.~Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population||months||95% Confidence Interval|Median
166747|NCT00179660|Secondary|Duration of Tumor Control|The duration of tumor control was calculated as the time from the first response assessment demonstrating at least stable disease to the first documentation of progressive disease or death due to NHL. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with tumor control (CR, CRu, PR or SD).||months||95% Confidence Interval|Median
166748|NCT00179660|Secondary|Duration of Response|The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent to treat population with a response = CR, CRu or PR.||months||95% Confidence Interval|Median
166749|NCT00179660|Secondary|Percentage of Participants With Tumor Control|"Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~SD was defined as a response less than a PR (see above) but not Progressive Disease (PD).~PD was defined as~≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders.~Appearance of any new lesion during or at the end of therapy."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.||percentage of participants||95% Confidence Interval|Number
166785|NCT00178685|Secondary|7 Day Point Prevelence (7DPP)|Seven-day point prevalence abstinence (7DPP) was assessed by asking: “Have you smoked a cigarette, even a puff, in the last 7 days?”16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users.|12 months after the intervention|820 individuals were randomized to condition, of those, 12 died during the course of the study (all deaths were found to be unrelated to the study). Final analysis number included all those randomized and excluded those who died during the study.||participants|||Number
166750|NCT00179660|Primary|Percentage of Participants With Response|"Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator.~CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD)~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).~PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD."|From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months.|Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.||percentage of participants||95% Confidence Interval|Number
166751|NCT00179647|Primary|Overall Incidence of Adverse Events|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks|Subjects who received study drug||Participants|||Number
166752|NCT00179647|Primary|Incidence of Adverse Events Summarized by System Organ Class, Preferred Term, Severity, Seriousness, and Relationship to Treatment.|Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.|Median time-on-study=18.3 weeks||||||
166753|NCT00179621|Secondary|Summary of Participants Who Had Adverse Events (AE) During the Double-blind Period|"Counts of study participants who had adverse events (AEs) during the double-blind period by MedDRA System Organ Class (SOC) and preferred term. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to week 52|Safety population.||participants|||Number
166754|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Fatigue (TOI-F) Endpoints at Week 12|The Trial Outcome Index-Fatigue(TOI-F) composed of the physical and functional subscales of the FACT-G along with the fatigue items from the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-F is 0-108. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-F data.||units on a scale||Standard Deviation|Mean
166755|NCT00179621|Secondary|Change From Baseline in the Trial Outcome Index-Anemia (TOI-An) Endpoints at Week 12|The Trial Outcome Index-Anemia (TOI-An) composed of the physical and functional subscales of the FACT-G along with the Anemia subscale was used to assess health-related quality of life (HRQoL). The overall score range for the TOI-An is 0-136. Higher scores indicate better HRQoL.|Baseline, Week 12|Participants who had both Baseline and Week 12 TOI-An data.||units on a scale||Standard Deviation|Mean
166756|NCT00179621|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Week 12|"The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire (Yellen, 1997) was used to assess health-related quality of life (HRQoL).~In addition to general HRQoL, the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning. The overall score range for the FACT-An is 0-188. Higher scores indicate better HRQoL."|Baseline, Week 12|Participants who had both Baseline and Week 12 FACT-An data.||units on a scale||Standard Deviation|Mean
166757|NCT00179621|Secondary|Participant Count of Deaths During Double-blind and Open-label by Randomized Group|Count of participant deaths throughout the entire study and reported by the original treatment assignment.|up to 3 years|Safety Population||Participants|||Number
166758|NCT00179621|Secondary|Kaplan Meier Estimates of Overall Survival by Randomized Group|Kaplan Meier estimate for median length of survival for study participants as they were randomized at the start of the study.|up to 3 years|Safety population: All randomized participants who received any Lenalidomide or placebo.||Months||95% Confidence Interval|Median
166759|NCT00179621|Secondary|Participants Who Progressed to Acute Myeloid Leukemia (AML) During the Study|Number of participants who progressed to acute myeloid leukemia during the study, summarized at three different timepoints: first 16 weeks of the double-blind study, week 52 of the double-blind study, and up to 36 months which includes the double-blind and open-label periods of the study. The counts are cumulative by timeframe.|up to 3 years|Intent to treat population. Participants represented in the treatment groups to which they were randomized.||Participants|||Number
166760|NCT00179621|Secondary|Participants Showing Cytogenetic Response by the International MDS Working Group (IWG 2000) During Double-blind Period as Evaluated by Central Review|The IWG criteria for evaluating cytogenetic response require a minimum of 20 baseline and post-baseline analyzable metaphases using conventional cytogenetic techniques. A major cytogenetic response is defined as no detectable cytogenetic abnormality if preexisting abnormality was present whereas a minor response requires ≥50% reduction in abnormal metaphases. Progression could be concluded based on as few as 3 metaphases if there were additional abnormalities. The best response is represented.|up to 52 weeks|Modified intent to treat population, which is defined as participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Participants had to have had more than 1 post-baseline assessment in order to be evaluable for cytogenetic response.||Participants|||Number
166761|NCT00179621|Secondary|Participants' Response Based on Bone Marrow Samples by the International MDS Working Group (IWG 2000) During Double-blind Period|The IWG criteria for bone marrow improvement: a complete remission is bone marrow sampling showing less than 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. A partial remission is ≥ 50% decrease in blasts over pre-treatment. Bone marrow progression is a ≥ 50% increase in blasts that exceed the top range of the pretreatment percentile range: a) <5% blasts b) 5-10% blasts c) 10-20% blasts d) 20-30% blasts. For example, a participant with <5% blasts pretreatment with an on study blast increase of 50% which is now >5% showed bone marrow progression.|up to 52 weeks|Intent to treat population. Participants represented in the treatment groups to which they were randomized. Placebo response is limited to the double-blind phase. There were 10 responders in the placebo group who achieved their response under lenalidomide treatment after crossover to open-label.||Participants|||Number
166762|NCT00179621|Secondary|Participants' Response in Absolute Neutrophil Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|A major neutrophil response is defined by the International MDS Working Group (IWG) criteria as at least a 100% increase, or an absolute increase of ≥500/mm^3 for participants with absolute neutrophil counts (ANC) of less than 1,500/mm^3 before therapy, whichever is greater. A minor response for such participants is defined as an ANC increase of at least 100%, but absolute increase <500/mm^3.|up to week 52|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline absolute neutrophil counts (ANC) < 1,000/mm^3.||Participants|||Number
166763|NCT00179621|Secondary|Participants' Response in Platelet Counts as Defined by the International MDS Working Group (IWG 2000) During Double-blind Period|The International MDS Working Group (IWG) defines a major platelet response for participants with a pre-treatment platelet count of <100,000/mm^3 as an absolute increase of ≥30,000/mm^3 whereas a minor response is defined as a ≥50% increase in platelet count with a net increase greater than 10,000/mm^3 but less than 30,000/mm^3.|up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. Additionally, the participant must have had a baseline platelet count of <100,000/mm^3 to be included in the analysis.||Participants|||Number
166764|NCT00179621|Secondary|Maximum Change From Baseline in Hemoglobin During the Double-blind Period for Participants Who Became Red Blood Cell (RBC) Transfusion Independent for at Least 182 Days|For participants who became RBC transfusion independent for at least 182 days during the double-blind study period, the mean maximum change from baseline in hemoglobin is summarized.|Baseline, up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug. MITT participants who were transfusion independent for >= 182 study days are included.||g/dL||Standard Deviation|Mean
166765|NCT00179621|Secondary|Duration of Red Blood Cell (RBC) Transfusion Independence for Participants Who Became RBC Transfusion Independent for at Least 182 Days|Mean number of weeks that participants who achieved RBC transfusion independence for at least 182 days were able to maintain RBC transfusion independence. Both double-blind and open-label periods are included.|up to 3 years|The modified intent-to-treat (mITT) population included all participants who achieved RBC transfusion independence for at least 182 days.||Weeks||Standard Deviation|Mean
166766|NCT00179621|Secondary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for 56 Days|Count of study participants who had no RBC transfusions during any 56 or more consecutive study days during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.||Participants|||Number
166767|NCT00179621|Primary|Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for >= 26 Weeks (182 Days)|The count of study participants who had no RBC transfusions for 26 consecutive weeks or more during the double-blind period.|Up to 52 weeks|The modified intent-to-treat (mITT) population included all participants with centrally-confirmed Low- or Int-1-risk MDS with del 5q[31] and documented RBC transfusion dependence who had received ≥ 1 dose of study drug.||Participants|||Number
166768|NCT00179309|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|80 months|||Participants|||Number
166769|NCT00179309|Primary|Progression-free Survival (PFS)|Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.|19.7 months|||Months||95% Confidence Interval|Median
166770|NCT00178919|Primary|Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition|Systolic blood pressure at the highest tolerated dose of IV infusion of L-NMMA during autonomic nervous system blockade with trimethaphan. Trimethaphan, infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|End of 15 minutes of infusion of L-NMMA at the highest tolerated dose|||mm Hg||Standard Deviation|Mean
166771|NCT00178919|Primary|Change in Systolic Blood Pressure|L-NMMA (nitric oxide synthase inhibitor) was infused intravenously at different doses for 15 minutes each, after blocking the autonomic nervous system with trimethaphan. The change in systolic blood pressure at the end of the highest tolerated dose is the main outcome. Trimethaphan infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.|At the end of the highest tolerated dose of IV infusion of L-NMMA|||mm Hg||Standard Error|Mean
166772|NCT00178841|Secondary|Pruritus Score|10-cm visual analog scale, 10= worst, 1=best|16 weeks|||units on a scale||Full Range|Mean
166773|NCT00178841|Secondary|Quality of Life Evaluations|FACT-G, Functional Assessment of Cancer Therapy-General (quality-of-life scale) 0= worst 108=best|baseline and every 4 weeks|||units on a scale||Full Range|Mean
166774|NCT00178841|Primary|Number of Participants With a 50% Improvement in Baseline Skin Score|mSWAT scoring. Range 0 to 400. Measured every 4 weeks.|16 weeks|||participants|||Number
166786|NCT00178685|Primary|12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.|The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.|12 months after subject completes intervention.|A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.||participants|||Number
166787|NCT00178633|Secondary|Change in Left Ventricular Mass|Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.|0-9 Months|broken out into 0-3months and 3-9months below||g/m^2.7||95% Confidence Interval|Mean
166788|NCT00178633|Secondary|Change in Tissue Doppler Diastolic Velocity|Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.|0-9 Months|Analysis broken down into 0-3 months and 3-9 months||cm/s||95% Confidence Interval|Mean
166789|NCT00178633|Secondary|Change in Glucose|Change in glucose. Negative values represent a decrease in glucose levels.|0-9 Months|broken out into 0-3months and 3-9months below||mg/dL||95% Confidence Interval|Mean
166790|NCT00178633|Primary|Change in Weight|Change in weight. Negative values represent weight loss.|0 to 9 months|broken out into 0-3months and 3-9months below||kg||95% Confidence Interval|Mean
166791|NCT00178503|Secondary|Mean Conners' Parent ADHD Index T Score by Week|The ADHD Index of the Conners' Parent Rating Scale-Revised (CPRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|||Units on a scale (T-scores)||Standard Deviation|Mean
166792|NCT00178503|Primary|Mean Continuous Performance Test (CPT)-Commission Errors by Dose|CPT is a measure of sustained attention using nonverbal stimuli (pictures). Participants are asked to click on the witch (target), which appears for 25% of the trials. Commission errors are measured by number of times they click for the non-target items.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|||Total Errors||Standard Deviation|Mean
166793|NCT00178503|Primary|Mean Conners' Teacher ADHD Index T Score by Dose|The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.|Measured at each dosing week of the drug trial (placebo, low, medium, high)|Although there were 24 participants who completed the trial, teacher ratings were only available for 18 participants due to 6 children being seen during the summer months.||Units on a scale (T-scores)||Standard Deviation|Mean
166794|NCT00178477|Primary|Tumor Motion Related to Breathing as Determined From MRI Images|"Determine the typical and maximal tumor 3D displacements over the respiratory cycle and how these values vary depending on the tumor location~Determine the reproducibility of target position over multiple breath-holds~Determine the variability across patients in respiratory-derived lesion motion and target position reproducibility over multiple breath-holds"|20 - 30 seconds|Data were not analyzed due to study termination.|||||
166795|NCT00178464|Primary|Number of Adverse Events|Occurrence of individual adverse events and relationship to aspirin|12 months|Intention to treat||events|||Number
166796|NCT00178464|Secondary|# of Subjects Recruited Over Time, Screening Failures, Withdrawal Rates;Compliance (Pill Counts & Labs);Changes in Performance on Neurocognitive Tests; Changes in MRI/MRA; Changes in TCD;Incidences of Stroke, Acute Chest Crises, and Pain Crises||12 months||||||
166797|NCT00178464|Primary|Number of Serious Adverse Events|Occurrence of individual serious adverse events and relationship to aspirin|12 months|Intention to treat||events|||Number
166798|NCT00178256|Secondary|Median Survival|This is median survival for all subjects enrolled.|86 months|||months||Full Range|Median
166799|NCT00178256|Primary|Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.||5 years|||Percentage subj w dose limiting toxicity|||Number
166800|NCT00178191|Primary|Episodes/Day|number of incontinence episodes/day|9 months|||number||Standard Error|Mean
166801|NCT00178178|Primary|Pain|Pain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.|3 day|||participants that experienced pain|||Number
166802|NCT00177970|Secondary|6) Patients' Length of Hospital Stay|During the course of the study, we expect the IVIG group compared to the placebo group will have a decrease in length of hospital stay.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166803|NCT00177970|Secondary|5) Normalization of Body Temperature During a 24 Hour Period|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal body temperature of 98.6 F.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166804|NCT00177970|Secondary|4) Normalization of Neutrophil Count on CBC With Diff.|During the course of the study, we expect the IVIG group compared to the placebo group will have normalization of neutrophil count (1.6-6.7)on CBC with diff.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166805|NCT00177970|Secondary|3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea|A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166808|NCT00177970|Primary|2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment|During the course of the study, we expect the IVIG group compared to the placebo group will have fewer number of stools per day (<3 per day).|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166809|NCT00177970|Primary|1) Normalization of WBC's|During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM|during the course of the study|No results available record destroyed due to age of study. no publications|||||
166810|NCT00177866|Secondary|Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment|No results or publication, data destroyed due to age of study.|completion of all study participants||||||
166811|NCT00177866|Primary|Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment|Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment|completion of all study participants|No results or publication, data destroyed due to age of study.|||||
166812|NCT00177671|Post-Hoc|Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.|Conversion to dementia was ascertained by the University of Pittsburgh Alzheimer Disease Research Center (ADRC), using data on neuropsychological performance and IADL functioning, as well as other relevant clinical data. Diagnoses were made according to National Alzheimer Coordinating Center criteria.|2 year|This is the percent of participants with mild cognitive impairment (MCI) in each arm of the study.||Percent of Participants|||Number
166813|NCT00177671|Primary|Number of Participants With Recurrence of Major Depression|Recurrence of major depressive episodes as determined by SCID/DSM IV: two weeks of low mood and/or anhedonia, together with at least five of the following symptoms: suicidal ideation, low energy, sleep disturbance, appetite disturbance, psychic anxiety or somatic anxiety. In addition, a diagnosis of major depression requires evidence of distress or impairment.|2 years|||participants||95% Confidence Interval|Number
166814|NCT00177671|Primary|Cognitive Instrumental Activities of Daily Living (IADL)|The PASS (a performance-based assessment of instrumental activities of daily living)generates a composite measure of 13 cognitive IADL items capturing performance on activities such as shopping, bill paying, medication management, and home safety. We report the percentage of subjects at each assessment point adjudged to have independent functioning. This was determined by a clinician rater observing subjects perform each task and rating them according to predetermined criteria on a 4 point scale, ranging from 0 (unable) to 3 (independent).|baseline, year 1 and year 2|Some participants refused this testing.||Percentage of participants|||Number
166815|NCT00177671|Primary|Global Cognitive Performance|Cognitive performance was assessed with 17 well established and validated individual tests measuring multiple domains. We transformed raw scores for individual tests into Z-scores using the baseline distribution of a non-depressed, cognitively normal, older adult comparison group (N=36)of similar age, education, and medical health recruited concurrently with the depressed participants. These Z-scores were averaged within each neuropsychological area to produce domain scores and then averaged over all 17 tests to calculate a global cognition performance score.|Measured at baseline and Years 1 and 2 in maintenance|||Z-score||Standard Deviation|Mean
166816|NCT00177307|Secondary|1-, 2-, and 3-year Overall Survival|Probability of being alive at 1-, 2-, and 3-years from start of protocol therapy|Up to 40 months|||percent chance|||Number
166817|NCT00177307|Secondary|Overall Survival|time from start of protocol therapy until death from any cause|Up to 40 months|||Months||95% Confidence Interval|Median
166818|NCT00177307|Secondary|Response Rate (RR)|Percentage of partial responses (PR) + complete responses (CR).|Up to 27 months|||percentage of participants|||Number
166819|NCT00177307|Primary|Progression Free Survival (PFS)|time from start of protocol therapy until objective tumor progression or death|Up to 27 Months|||Months||95% Confidence Interval|Median
166820|NCT00177294|Primary|Remission|Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression.|Measured at Week 6 or 22|||Percentage of participants||95% Confidence Interval|Number
166821|NCT00177255|Secondary|Overall Response Rate|The number of responders (complete responders + partial responders) divided by the number of evaluable patients.|Every 2 cycles (6 weeks)|||percentage of participants||95% Confidence Interval|Number
166822|NCT00177255|Primary|Overall Survival|The time interval between the date on which a patient first received protocol treatment and the documented date of death.|2 years|||Months||95% Confidence Interval|Median
166823|NCT00177216|Primary|Change in Diary Sleep Efficiency|The change in self-report sleep efficiency calculated from 7-day sleep diary (DSE): Sleep efficiency is the percent of (time spent asleep divided by the amount of time between good night time and final awakening). It ranges from 0 (no sleep at all) to 100 (asleep the second your head hits the pillow until you wake up in the morning and get out of bed). Participants report the time they go to bed, how long they think it takes them to fall asleep, how many minutes they are awake during the night, and then what time they finally wake up in the morning. These values are used to calculate the diary sleep efficiency for each night and then we averaged these across the 7 days of diary collected pre and post treatment. The values below are post treatment DSE minus pre treatment DSE. A positive number means that the DSE was higher (better) post treatment.|post treatment minus baseline. This averaged 69 days.|The number of subjects with sleep diaries at baseline and after at least 5 weeks of treatment. Not all of these participants 'completed' the protocol||diff score of diary Sleep Efficiency||Standard Deviation|Mean
166824|NCT00177216|Primary|Change in Pittsburgh Sleep Quality Index|Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved.|post treatment minus baseline assessment battery. This averaged 100 days.|Number of subjects who had total PSQI scores after at least 5 weeks of treatment. The PSQI requires that all questions be answered for a total score to be calculated. This analysis includes participants who did not complete the protocol and also omits those who has missing total scores due to missing items on the PSQI||difference score of PSQI total||Standard Deviation|Mean
167484|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMC||Full Range|Median
166825|NCT00177216|Secondary|Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint|Change in PSG Sleep Efficiency (SE) between post-treatment and baseline: Sleep efficiency is the percent of time spent asleep divided by the total sleep recording period in the sleep lab. This value is calculated using the results of the polysomnographic sleep study. It ranges from 0 (no sleep at all) to 100 (asleep the second the sleep recording starts (GNT) until the sleep recording ends (GMT) in the morning). The values below are post treatment SE minus pre treatment SE. A positive number means that the SE was higher (better) post treatment.|post treatment minus baseline PSG sleep studies. This averaged 70 days|Number of subjects who had polysomnography at Week 9 and at pretreatment. Some of the participants who 'completed' the protocol did not have follow up sleep studies.||difference score for SE||Standard Deviation|Mean
166826|NCT00177164|Secondary|Number of Participants With Treatment Emergent Hyperlipidemia|Number of participants with Hyperlipidemia as determined by safety labs|from baseline to end of 15 months|patients with bipolar disorder||participants|||Number
166827|NCT00177164|Secondary|Number of Participants With Treatment - Emergent Hyperglycemia|Number of participants with hyperglycemia based on safety labs|from baseline to end of 15 months|patients with bipolar disorder||participants|||Number
166828|NCT00177164|Secondary|BMI|BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups|baseline to end of 15 months|Patients with bipolar disorder||kg / m^2||Standard Deviation|Mean
166829|NCT00177164|Primary|Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.||Upto 15 months|2 patients in the risperidone LAI group were not included in the ITT (intention to treat) analyses as they did not receive assessment after the baseline assessment. Therefore, outcomes were assessed for only 23 of 25 patients in the risperidone LAI group.||Number of clinical events||Standard Deviation|Mean
166830|NCT00176917|Secondary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (aGVHD).|Toxicity (undesireable effect) of this stem cell transplant preparative regimen due to acute graft-versus-host disease.|Day 100 Post Transplant|||Participants|||Number
166831|NCT00176917|Secondary|Number of Patients Who Failed Engraftment.|Toxicity (undesireable effect) of hematologic donor cell engraftment is determined by failure to engraft at Day 42.|Day 42 Post Transplant|1 patient of 41 failed engraftment - per protocol.||Participants|||Number
166832|NCT00176917|Secondary|Number of Patients Surviving on Study|Number of patients surviving (alive) at specified timepoints.|at 100 days, 1 year, and 3 years post transplant|Day 100 and 1 Year timepoints include all 41 patients. Year 3 includes 36 patients (5 pts not yet at followup timepoint.)||Participants|||Number
166833|NCT00176917|Primary|Mean Percentage of Donor Cells in Study Population (Chimerism).|Donor-derived engraftment determined by restriction fragment length polymorphism (RFLP).|at 21 days, 42 days, 60 days, 100 days, 6 months, and 1 year|Day 21 (24 patients included), Day 42 (15 pts), Day 60 (29 pts), Day 100 (25 pts), 6 Months (18 pts), 1 Year (16 pts).||Percentage||Standard Deviation|Mean
166834|NCT00176904|Secondary|Number of Patients With Chronic Graft-Versus-Host Disease|Number of patients who exhibited chronic graft-versus-host disease by 1 Year post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Chronic GVHD is an extension of this syndrome.|1 Year Post Transplant|||Participants|||Number
166835|NCT00176904|Secondary|Number of Patients With Grade III-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100|||Participants|||Number
166836|NCT00176904|Secondary|Number of Patients With Grade II-IV Acute Graft-Versus-Host Disease|Number of patients who exhibited acute graft-versus-host disease by Day 100 post transplant. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Grade I=mild, Grade II=moderate, Grade III=severe, Grade IV=life threatening.|Day 100|||Participants|||Number
166837|NCT00176904|Secondary|Overall Donor Engraftment|Number of patients with full donor chimerism (state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease) by Day 100 post-transplant of at least 90%.|Day 100|1 Patient not included due to early death (before day 40).||Participants|||Number
166838|NCT00176904|Primary|Overall Survival|Number of patients alive at designated timepoints after transplant.|100 Days, 1 Year and 3 Years|||Participants|||Number
166839|NCT00176878|Secondary|Number of Patients With Disease Recurrence|Number of patients who exhibited disease recurrence at 2 years.|2 years|||Participants|||Number
166840|NCT00176878|Secondary|Number of Patients With Chronic Graft Versus Host Disease|Number of patients who exhibited chronic (normally occurs after 100 days) Graft Versus Host Disease at 2 years post transplant. Chronic graft-versus-host-disease, over its long-term course, can also cause damage to the connective tissue and exocrine glands.|2 years|||Participants|||Number
166841|NCT00176878|Secondary|Number of Patients With Grade 2-4 Acute Graft Versus Host Disease|Number of patients with Grade 2, 3 and 4 Acute (normally observed within the first 100 days) Graft Versus Host Disease. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of 1 to a high of 4. Patients with grade IV GVHD usually have a poor prognosis. Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening.|100 Days|||Participants|||Number
166842|NCT00176878|Secondary|Number of Patients With Succcessful Engraftment After Transplantation|"Number of patients who received non-genotypic identical marrow or cord blood cells using a non-myeloablative preparative regimen and exhibited engraftment at Day 42."|42 Days|||Participants|||Number
166843|NCT00176878|Secondary|Number of Patients Alive at Three Years (Survival)|Number of subjects who survived 3 years post-transplant.|3 years|||Participants|||Number
166844|NCT00176878|Primary|Number of Patients Alive (Survival) at 2 Years|Calculated from day 1 of transplant to last contact.|2 years|||Participants|||Number
166845|NCT00176839|Secondary|Incidence of Relapse|Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year|||participants|||Number
166846|NCT00176839|Secondary|Incidence of Regimen-related Toxicity 100 Days Post Transplant|Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant|||participants|||Number
166847|NCT00176839|Secondary|Incidence Chronic Graft-versus-host Disease (GVHD)|Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year|||participants|||Number
166848|NCT00176839|Secondary|Incidence of Acute Graft-versus-host Disease (GVHD)|Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|100 days post-transplant|||participants|||Number
166849|NCT00176839|Secondary|Probability of Engraftment|Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies..|1 year|||participants|||Number
166850|NCT00176839|Primary|Probability of Long-term Disease-free Survival (DFS)|Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.|1 year|||participants|||Number
166851|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||3 years|||participants|||Number
166852|NCT00176826|Secondary|Number of Patients With III-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||participants|||Number
166853|NCT00176826|Secondary|Number of Patients With Graft Failure||Day 100 Post transplant|||participants|||Number
166854|NCT00176826|Secondary|Number of Patients With Grade II-IV Graft-Versus-Host Disease (GVHD)||Day 100 Post Transplant|||participants|||Number
166855|NCT00176826|Secondary|Number of Patients Surviving (Disease-free)||1 year|||participants|||Number
166856|NCT00176826|Secondary|Number of Patients With Treatment Related Mortality.||Day 100 Post Transplant|||participants|||Number
166857|NCT00176826|Primary|Time to Transplant Engraftment||Day 100 Post Transplant|||days||Standard Deviation|Mean
166858|NCT00176800|Secondary|Percentage of Patients That Require Dose Modification Due to Toxicity||8 years|||percentage of patients|||Number
166859|NCT00176800|Secondary|Median Overall Survival Time|To measure the survival time in patients treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years|||months||95% Confidence Interval|Median
166860|NCT00176800|Primary|Median Recurrence Free Survival Time|To measure the time recurrence in patients with esophageal cancer treated with preoperative chemoradiation, surgery, and post-operative tetrathiomolybdate.|8 years|||months||95% Confidence Interval|Median
166861|NCT00176644|Secondary|To Assess the Plateau Level of Estradiol That is Attained With the Dose of 0.4mg/Day Given Via Transdermal Estradiol Patch and in Addition, Assess the Response on Testosterone in the Androgen Resistant Population.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
166862|NCT00176644|Secondary|To Evaluate Time to Progression.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
166863|NCT00176644|Secondary|To Evaluate Measurable Disease Response in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
166864|NCT00176644|Secondary|To Measure Quality of Life of Patients Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).||4 years|Analysis was not conducted as therapy was determined to be ineffective (response rate < 20%).|||||
166865|NCT00176644|Primary|To Evaluate the Antitumor Activity, as Measured by PSA Response Rate in Patients With Hormone and Chemotherapy Refractory Prostate Cancer.||4 years|||Response rate (percentage)|||Number
166866|NCT00176631|Secondary|Proportion of Patients With a Decrease in BCL-2 Levels in PBMC and in the Degree of Plasma ER Receptor, Between Patients Who Responded to Treatment and Patients Who Did Not||7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
166867|NCT00176631|Primary|Percentage of Patients With PSA Response|Decline from baseline value by > 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.|7 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.|||||
166868|NCT00176605|Secondary|Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.|All patients who receive one dose of protocol therapy will be evaluable for toxicity. A total of 15 patients received at least one dose of protocol therapy. Adverse events are described in Adverse Event section.|5 years|No subjects experienced serious adverse events related to the intervention.||participants|||Number
166869|NCT00176605|Primary|PSA Response Rate|The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.|5 years|||percentage of participants|||Number
166870|NCT00176501|Secondary|Rate of Graft-vs-host Disease||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.|||||
166871|NCT00176501|Secondary|Rate and Kinetics of Clinical/Radiological Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.|||||
166872|NCT00176501|Primary|Response Rate|With regard to responses, this trial will use a two-stage Simon’s design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.|5 years|The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.|||||
166873|NCT00176488|Secondary|Correlate Tumor Response With Changes in the Gene Expression of Microtubule Associated Protein 4 (MAP4).||10 years|Study was closed prematurely and insufficient data was collected.|||||
166877|NCT00176462|Primary|Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years|This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.|5 years|Number of high risk ALL patients treated.||percentage of participants|||Number
166878|NCT00176436|Secondary|Chemistry Panel||baseline, 10 weeks and 24 weeks||||||
166879|NCT00176436|Secondary|Vital Signs||Weekly for 24 weeks||||||
166880|NCT00176436|Secondary|Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.||24 weeks||||||
166881|NCT00176436|Primary|Change From Baseline in Weight|Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.|Weekly for 24 weeks|||kilograms||Standard Deviation|Mean
166882|NCT00176306|Primary|Area Under the Curve|The objective of this study is to determine if therapeutic concentrations are likely after giving a standard dose of levofloxacin to critically ill obese individuals|24 hours|pilot study||mg/L*hr||Standard Deviation|Mean
166883|NCT00176254|Secondary|5 Year Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years|||participants|||Number
166884|NCT00176254|Secondary|5 Year Disease-specific Survival|Outcome is calculated from the time of enrollment to the time of death due to disease under study or survival to 5 years without death from disease under study, whichever occurs first.The 5-year rates of disease-specific survival were calculated using the Kaplan-Meier method.|5 years|||participants|||Number
166885|NCT00176254|Secondary|5 Year Overall Survival Rates||5 years post study|||participants|||Number
166886|NCT00176254|Secondary|Frequency of Severe (>/= Grade 3) Toxicities||assessed starting on day 1 through study day 58 or until toxicity resolves|Intent to Treat||adverse events|||Number
166887|NCT00176254|Primary|Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|assessed pre-study and once between days 36-57|||participants|||Number
166888|NCT00176228|Secondary|Child Depression Rating Scale (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children’s Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|weekly at baseline and each week during osing (8 weeks) and dose stabilized phase (6 weeks)|||units on a scale||Standard Deviation|Mean
166889|NCT00176228|Primary|Young Mania Rating Scale (YMRS),|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient’s subjective report of his or her condition over the previous forty-eight hours and the clinician’s behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.|Weekly during the 8 week lamotrigine dose titration and 6 week full dose phase.|||units on a scale||Standard Deviation|Mean
166890|NCT00176202|Secondary|Clinical Global Improvement in Bipolar Disorder Overall (CGI-BP Overall)|Severity of Illness and Global Improvement are rated on a 7-point scale by the clinician. In addition to rating the overall illness with the CGI-BP, severity and improvement are considered on various other dimensions such as mania, depression, attention deficit/hyperactivity, psychosis, aggression and sleep difficulties. Score of 1, 2 and 3 would mean there is clinically observed symptom improvement where 1 is the best outcome than 2 or 3. The point 4 is the point where the subject presents at baseline of that specific individual. If they become worse on clinical symptoms, they are rated as 5, 6 or 7 where 7 is worse than 5.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|||units on a scale||Standard Deviation|Mean
166891|NCT00176202|Secondary|Child Mania Rating Scale (CMRS)|Child Mania rating scale is a parent rated measure to screen for symptoms of mania. It includes 21 items reflecting the DSM-IV criteria for a manic episode. Each item is answered on a four-point Likert type scale anchored by 0 (Never/Rare), 1 (Sometimes), 2 (Often), and 3 (Very Often). Maximum score possible is 63. Score higher than 20 is considered clinically significant, and this is a dimensional score of manic severity.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|||units on scale||Standard Deviation|Mean
166892|NCT00176202|Secondary|Child Depression Rating Scale- Revised (CDRS-R)|Response for depressive symptoms was defined as a score less than 40 on the CDRS-R. Range is 18 to 120. Score 18 is normal and higher score signifies depression. The Children’s Depression Rating Scale (CDRS) is a 16-item measure used to determine the severity of depression in children 6-18 years of age. Items are measured on 3-, 4-, 5-, and 6-point scales. The mean and standard deviation are measured in this study to illustrate outcome at baseline and when the subject ended the study.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|||units on a scale||Standard Deviation|Mean
167241|NCT00168831|Secondary|Weekly Mean Morning Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
166893|NCT00176202|Primary|Young Mania Rating Scale (YMRS)|This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. We show the mean and standard deviation at week 0 and 6.|Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).|Inclusion criteria were a DSM-IV diagnosis of bipolar disorder Type I (mixed or manic episode); 8 to 18 years old; and medication free or currently clinically unstable on medication, justifying termination of the ineffective regimen.||units on a scale||Standard Deviation|Mean
166894|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.||units on a scale||Standard Deviation|Mean
166895|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 777 are included in this analysis. Data not available for 69 subjects.||units on a scale||Standard Deviation|Mean
166896|NCT00175877|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.||percentage of participants|||Number
166897|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 834 are included in this analysis. Data not available for 12 subjects.||units on a scale||Standard Deviation|Mean
166898|NCT00175877|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 838 are included in this analysis. Data not available for 8 subjects.||hours||Standard Deviation|Mean
166899|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire – Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 824 are included in this analysis. Data not available for 22 subjects.||units on a scale||Standard Deviation|Mean
166900|NCT00175877|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 661 are included in this analysis. Data not available for 185 subjects.||units on a scale||Standard Deviation|Mean
166924|NCT00175019|Secondary|Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit.|The number of tophi were counted at baseline and final visits. The percent change from baseline in the number of tophi to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline who also had their tophi counted while receiving their final stable treatment were included in the analysis.||percent change from baseline||Standard Deviation|Mean
166901|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.||percentage of participants||95% Confidence Interval|Number
166902|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240|The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.||percentage of participants||95% Confidence Interval|Number
166903|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192|The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.||percentage of participants||95% Confidence Interval|Number
166904|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144|The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.||percentage of participants||95% Confidence Interval|Number
166905|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96|The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.||percentage of participants||95% Confidence Interval|Number
166906|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48|The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.||percentage of participants||95% Confidence Interval|Number
166907|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.||percentage of participants||95% Confidence Interval|Number
166938|NCT00174967|Secondary|Maximum Percent Change in Serum Urate Level From Baseline During the Entire Treatment Period.|Serum urate values were obtained at the Day 7, 14, 21,and 28 visits. The maximum percent change in serum urate levels obtained at any visit was summarized.|Baseline and Any visit (Day 7, 14, 21,or 28)|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL.||percent change from baseline||Standard Deviation|Mean
166908|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240|The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.||percentage of participants||95% Confidence Interval|Number
166909|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192|The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.||percentage of participants||95% Confidence Interval|Number
166910|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144|The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.||percentage of participants||95% Confidence Interval|Number
166911|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96|The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.||percentage of participants||95% Confidence Interval|Number
166912|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48|The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.||percentage of participants||95% Confidence Interval|Number
166913|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)|Of the 846 subjects in the Safety Set (SS), 841 are included in this analysis. Data not available for 5 subjects.||percentage of participants||95% Confidence Interval|Number
166914|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240|The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 240 of the open-label study|Of the 846 subjects in the Safety Set (SS), 183 are included in this analysis. Data not available for 663 subjects.||percentage of participants||95% Confidence Interval|Number
166925|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized.|Final Visit (up to 40 months).|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured while receiving their final stable treatment were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
166915|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192|The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 192 of the open-label study|Of the 846 subjects in the Safety Set (SS), 537 are included in this analysis. Data not available for 309 subjects.||percentage of participants||95% Confidence Interval|Number
166916|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144|The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 144 of the open-label study|Of the 846 subjects in the Safety Set (SS), 602 are included in this analysis. Data not available for 244 subjects.||percentage of participants||95% Confidence Interval|Number
166917|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96|The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 96 of the open-label study|Of the 846 subjects in the Safety Set (SS), 668 are included in this analysis. Data not available for 178 subjects.||percentage of participants||95% Confidence Interval|Number
166918|NCT00175877|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48|The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 48 of the open-label study|Of the 846 subjects in the Safety Set (SS), 733 are included in this analysis. Data not available for 113 subjects.||percentage of participants||95% Confidence Interval|Number
166919|NCT00175877|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.|From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)|Safety Set||percentage of participants|||Number
166920|NCT00175877|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"A SAE is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalisation or prolongation of existing hospitalisation~Results in persistent or significant disability/incapacity, or~Is a congenital anomaly or birth defect~Is as infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above~First dose of CZP was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set||percentage of participants|||Number
166921|NCT00175877|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study [NCT00152386] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 7 years)|Safety Set||percentage of participants|||Number
166922|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare After Month 12.|The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized.|After Month 12 to Final Visit|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.||percentage of subjects|||Number
166923|NCT00175019|Secondary|Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12.|The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once.||percentage of subjects|||Number
167217|NCT00168844|Secondary|Change From Baseline in Haematocrit, Packed Cell Volume (PCV)|Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Percentage of erythrocytes||Standard Deviation|Mean
166926|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized.|Month 36|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 36 visit were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
166927|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized.|Month 24|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 24 visit were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
166928|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment.|The percentage of subjects whose serum urate was <6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.||percentage of subjects|||Number
166929|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 36 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
166930|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 24 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
166931|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 12 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
166932|NCT00175019|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.|Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 1 visit was summarized.|Month 1|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 1 visit and who had not changed from their initial treatment were included in the analysis.||percentage of subjects|||Number
166933|NCT00175019|Secondary|Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline.|The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized.|Month 12|Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 12 visit were included in the analysis.||percent change from baseline||Inter-Quartile Range|Median
166934|NCT00175019|Secondary|Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment.|The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment.|Last Visit on treatment (up to 40 months).|Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis.||percent change from baseline||Standard Deviation|Mean
166935|NCT00175006|Primary|Average Percent Difference in Area Between Raters|Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.|Visit 1 (Day 1 ) and Visit 2 (Day 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled.||mm²||Standard Deviation|Mean
166936|NCT00175006|Primary|Average Percent Difference in Area Between Visits|The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. Change in tophus size over 10 days was not expected.||mm²||Standard Deviation|Mean
166937|NCT00174967|Secondary|Percent Change in 24-hour Urine Uric Acid Level From Baseline to Day 28.|24-hour urine uric acid levels were obtained at the Day 28 visit. The percent change in 24-hour urine uric acid level from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. Missing data was not imputed||percent change from baseline||Standard Deviation|Mean
166939|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percent change in serum urate from baseline to the Day 28 visit was summarized.|Baseline and Day 28.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
166940|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 21 Visit|Serum urate values were obtained at the Day 21 visit. The percent change in serum urate from baseline to the Day 21 visit was summarized.|Baseline and Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
166941|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percent change in serum urate from baseline to the Day 14 visit was summarized.|Baseline and Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
166942|NCT00174967|Secondary|Percent Change in Serum Urate Levels From Baseline to the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percent change in serum urate from baseline to the Day 7 visit was summarized.|Baseline and Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percent change from baseline||Standard Deviation|Mean
166943|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 21 Visit.|Serum urate values were obtained at the Day 21 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 21 visit was summarized.|Day 21.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percentage of subjects|||Number
166944|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 14 Visit.|Serum urate values were obtained at the Day 14 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 14 visit was summarized.|Day 14.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percentage of subjects|||Number
166945|NCT00174967|Secondary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 mg/dL at the Day 7 Visit.|Serum urate values were obtained at the Day 7 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 7 visit was summarized.|Day 7.|The analysis was performed on ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥ 8.0 mg/dL. The LOCF method was used to impute missing data. The baseline value was carried forward if no post-baseline visits were available.||percentage of subjects|||Number
166946|NCT00174967|Primary|Percentage of Subjects Whose Serum Urate Level Decreased to <6.0 Milligram Per Deciliter (mg/dL) at the Day 28 Visit.|Serum urate values were obtained at the Day 28 visit. The percentage of subjects whose serum urate decreased to <6.0 mg/dL at the Day 28 visit was summarized.|Day 28.|Analysis performed on intent-to-treat (ITT) subjects, defined as all randomized subjects who took at least 1 dose of study drug and who had baseline serum urate ≥8.0 mg/dL. The last observation carried forward (LOCF) method was used to impute missing data. The baseline value was carried forward if no postbaseline visits were available.||percentage of subjects|||Number
166947|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volume Between Readers|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in Reader 2 volume and Reader 1 volume for the same tophus were pooled across visits.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements from both readers at the same visit.||cm³||Standard Deviation|Mean
166948|NCT00174954|Primary|Measurement of Tophi by MRI - Difference in Volument Between Visits|Two independent readers determined volume of the same tophus by MRI at 2 separate visits scheduled no more than 10 days apart. Difference in volume between Visit 1 and 2 for the same tophus was pooled across readers.|Visit 1 (Day 1) and Visit 2 (Days 6-11)|Analysis was performed on the subjects with MRI tophus volume measurements at both visits from the same reader. Change in tophus size over 10 days was not expected.||centimeters³ (cm³)||Standard Deviation|Mean
166949|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Final Visit.|The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Baseline and Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
166950|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 60 Visit.|The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation.|Baseline and Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
167485|NCT00165698|Secondary|Bone Mineral Content BMC (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMC||Full Range|Median
166951|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized.|Baseline and Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
166952|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized.|Baseline and Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
166953|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized.|Baseline and Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
166954|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized.|Baseline and Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
166955|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized.|Baseline and Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects||Standard Deviation|Mean
166956|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Final Visit.|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected.|Last Visit on treatment (up to 66 months).|Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166957|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit.|Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized.|Month 60|Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166958|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit.|Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.|Month 48|Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166959|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit.|Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized.|Month 36|Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166960|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit.|Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized.|Month 24|Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166961|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit.|Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized.|Month 18|Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166962|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit.|Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized.|Month 12|Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166963|NCT00174941|Secondary|Percent Change in Serum Urate Levels From Baseline at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.|Baseline and Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percent change from baseline||Standard Deviation|Mean
166964|NCT00174941|Primary|Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit.|Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.|Month 6|Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit.||percentage of subjects|||Number
166965|NCT00174915|Secondary|Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.|Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 28|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 28.||percentage of subjects|||Number
166966|NCT00174915|Secondary|Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit|Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
166967|NCT00174915|Secondary|Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
166968|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
166969|NCT00174915|Secondary|Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
166970|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as [(Final visit - baseline levels)/baseline]*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 28 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percent change||Standard Deviation|Mean
166971|NCT00174915|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(Week 28 - baseline levels)/baseline]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percent change||Standard Deviation|Mean
166972|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected and may have differed by subject.|Final Visit (up to 28 weeks).|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
166973|NCT00174915|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on intend to treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
166974|NCT00174915|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).|Each subject’s serum urate at the last 3 visits determined the subject’s response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 visits (any last 3 visits up to week 28)|Analysis was performed on all randomized subjects who took at least 1 dose of study drug and had a baseline serum urate ≥8.0 mg/dL. If subject prematurely discontinued from study before at least 3 serum urate levels were obtained, subject was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used.||Percentage of subjects|||Number
166975|NCT00174785|Other Pre-specified|Adjudicated Cardiovascular Death|The considered event is cardiovascular death, as assessed by the blinded adjudication of the Steering Committee. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
166976|NCT00174785|Secondary|Cardiovascular Death|The considered event is cardiovascular death, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
166977|NCT00174785|Secondary|First Hospitalization for Cardiovascular Reason|The considered event is the first hospitalization for cardiovascular reason, as assessed by the Investigator. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
166978|NCT00174785|Secondary|Death From Any Cause|The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|«All randomized patients» population||participants|||Number
166979|NCT00174785|Primary|First Hospitalization for Cardiovascular Reason or Death From Any Cause|The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.|minimum follow-up duration: 1 year ; maximum: 2.5 years|"All efficacy analyses were performed on the all randomized patients population including all patients randomized irrespective of whether the patient actually received any drug or complied with the study protocol."||participants|||Number
166980|NCT00174460|Secondary|Growth Curve Comparison Based on Height: Control Arm|Growth curve comparison with height in centimeters as the dependent variable.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.||centimeters||Standard Error|Least Squares Mean
166981|NCT00174460|Secondary|Growth Curve Comparison Based on Height|Growth curve comparison with height in centimeters as the dependent variable.|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.||centimeters||Standard Error|Least Squares Mean
166982|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS: Control Arm|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.|Month 36|FAS; Control group received Somatropin from Month 12 onwards. N=number of subjects with evaluable data at observation. Month 36 visit not applicable to Somatropin treatment group.||centimeters||Standard Error|Least Squares Mean
166983|NCT00174460|Secondary|Growth Curve Comparison Based on Height SDS|Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Data for Month 36 (applicable only to the Control Arm) is reported in a separate outcome measure.||centimeters||Standard Error|Least Squares Mean
166984|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Control Arm|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 36|FAS; Control group received Somatropin from Month 12 onwards.||participants|||Number
166985|NCT00174460|Secondary|Number of Participants With Change in Insulin Sensitivity: Somatropin|Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.|Baseline, Month 24|FAS||participants|||Number
166986|NCT00174460|Secondary|Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years|Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants ≥6 years of age with evaluable data at observation for Somatropin and Control Arm, respectively. SDS reference values used were for the right hand but the hand grip strength measured for this study was for the dominant hand (may not have been the right hand).||z-score||Standard Error|Least Squares Mean
166987|NCT00174460|Secondary|Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)|Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
166988|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)|Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Marrow Area was not analyzed as planned.||z-score||Standard Error|Least Squares Mean
166989|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)|Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. Cortical thickness was not analyzed as planned.||z-score||Standard Error|Least Squares Mean
166990|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)|Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
166991|NCT00174460|Secondary|Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)|Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
166992|NCT00174460|Secondary|Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)|Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
166993|NCT00174460|Primary|Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year|Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|FAS; Control group received Somatropin from Month 12 onwards.||centimeters per year||Standard Error|Least Squares Mean
166994|NCT00174460|Secondary|Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years|Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant’s age and sex; negative values are below the average.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards; (n)=number of participants from FAS with evaluable pQCT data for somatropin and control arm groups, respectively.||z-score||Standard Error|Least Squares Mean
166995|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac|Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.||millimeters||Standard Error|Least Squares Mean
166996|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular|Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.||millimeters||Standard Error|Least Squares Mean
166997|NCT00174460|Secondary|Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps|Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards. N=number of participants with evaluable data at observation.||millimeters||Standard Error|Least Squares Mean
167486|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Trochiter After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMD||Full Range|Median
166998|NCT00174460|Secondary|Change From Baseline in Height SDS After 2 Years|Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters||Standard Error|Least Squares Mean
166999|NCT00174460|Secondary|Change From Baseline in Height After 1 Year and After 2 Years||Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters||Standard Error|Least Squares Mean
167000|NCT00174460|Secondary|Change From Baseline in Growth Velocity SDS After 2 Years|Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters per year||Standard Error|Least Squares Mean
167001|NCT00174460|Secondary|Change From Baseline in Growth Velocity After 1 Year and After 2 Years|Growth velocity measured as centimeters per year.|Baseline, Month 12, Month 24|FAS; Control group received Somatropin from Month 12 onwards.||centimeters per year||Standard Error|Least Squares Mean
167002|NCT00174460|Primary|Change in Height Standard Deviation Score (SDS) After 1 Year|Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).|Baseline to 1 year (Month 12)|Full Analysis Set (FAS; all randomized subjects who had at least 1 post-baseline efficacy measurement); Control group received Somatropin from Month 12 onwards.||centimeters||Standard Error|Least Squares Mean
167003|NCT00174447|Primary|Change From Baseline in CGI-S at End of Study (up to 5 Years)|CGI-S Scale: standardized assessment tool to rate severity of subject’s illness; assesses investigator’s impression of subject’s current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.||score on a scale||Standard Deviation|Mean
167004|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S Scale: standardized assessment tool to rate severity of subject’s illness; assessed investigator’s impression of subject’s current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|ITT. LOCF.||participants|||Number
167005|NCT00174447|Secondary|Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)|DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Baseline, up to 5 years (End of Study)|ITT. n= number of participants with analyzable data.||score on a scale||Standard Deviation|Mean
167006|NCT00174447|Secondary|Number of Participants With Scores on Patient Preference Scale (PPS)|Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.|Baseline, up to 5 years (End of Study)|ITT||participants|||Number
167007|NCT00174447|Primary|Change From Baseline in CGI-I at End of Study (up to 5 Years)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Change from baseline is score at observation minus score at baseline.|Baseline, up to 5 years (End of Study [LOCF])|ITT. LOCF.||score on a scale||Standard Deviation|Mean
167008|NCT00174447|Primary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I consists of a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]|Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).||participants|||Number
167009|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I) Dichotomized Response|Scale measures subject’s (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more|Baseline, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy. LOCF = Last Observation Carried Forward. Week 24 n=116; Week 24 LOCF n=136||Particpants|||Number
167010|NCT00174382|Secondary|Clinical Global Impressions Improvement (CGI-I)|Scale measures subject’s clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Week (wk) 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with value (Week 24 n=116; Week 24 LOCF n=136)||Participants|||Number
167011|NCT00174382|Secondary|Clinical Global Impressions Severity (CGI-S)|Scale measures subject’s clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).|Baseline|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. n=number of subjects with a value||Participants|||Number
167012|NCT00174382|Secondary|Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)|Scale measures subject’s clinical condition at baseline for severity (CGI-S) & for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline|Baseline, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. Subjects with Baseline = 136; week 24 n = 116; week 24 LOCF n = 136||Score on a scale||Standard Deviation|Mean
167013|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)|The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF n=137; weeks 12, 24 n = 124, 114||Score on a scale||Standard Deviation|Mean
167014|NCT00174382|Secondary|Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)|NPI-Q measures severity of behavioural manifestations of dementia & the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores & ranges from 0 to 36|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=137; weeks 12, 24 n = 124, 114||Score on scale||Standard Deviation|Mean
167015|NCT00174382|Secondary|Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)|The number of words a particpant can generate in 1 minute.|Baseline, 12 weeks, week 24|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF n=136; weeks 12, 24 n = 123, 113||score on scale||Standard Deviation|Mean
167016|NCT00174382|Secondary|CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)|CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF N=131; weeks 12, 24 n = 117, 106||Score on a scale||Standard Deviation|Mean
167017|NCT00174382|Secondary|Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)|The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. LOCF N=131; weeks 12, 24 n = 117, 106||Score on scale||Standard Deviation|Mean
167018|NCT00174382|Secondary|Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)|The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; weeks 12, 24 n = 123, 111||Score on a scale||Standard Deviation|Mean
167019|NCT00174382|Secondary|Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)|DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n = 124, 114||score on a scale||Standard Deviation|Mean
167020|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.|IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance & correspondence, medications, leisure & housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered|Baseline, 12 weeks, 24 weeks|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124,114||score on a scale||Standard Deviation|Mean
167021|NCT00174382|Secondary|Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.|The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.|Baseline, week 12, week 24|Full Analysis Set (FAS): all subjects who received at least one dose of donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.N=137; Weeks 12, 24 n= 124, 114.||score on a scale||Standard Deviation|Mean
167022|NCT00174382|Primary|Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set|Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.|Baseline, week 12, week 24|Full Analysis Set (FAS):all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward. N=137; Weeks 12, 24 n=124, 114||Score on a scale||Standard Deviation|Mean
167023|NCT00174291|Secondary|Change From Baseline in Corticosteroid Dose at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||mg||Full Range|Median
167048|NCT00174252|Other Pre-specified|Summary of Body Mass Index (BMI) at 12 and 24 Months|BMI was calculated at 12 months and 24 months as: (Weight at 12 or 24 months divided by Height at 12 or 24 months) squared|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BMI data at 12 and 24 months.||kg/meters squared (m2)||Standard Deviation|Mean
167218|NCT00168844|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
167024|NCT00174291|Secondary|Change From Baseline in Weight Standard Deviation Score (SDS) at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender- appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||SDS||Full Range|Median
167025|NCT00174291|Secondary|Change From Baseline in Bone Mineralization at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Bone mineralization, an estimate of the amount of mineral (such as calcium) in the bone, was assessed using DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||grams||Full Range|Median
167026|NCT00174291|Secondary|Change From Baseline in Lean Mass and Fat Mass at Year 1, 2, 3, 4, 5, 6, 7, 8 and 9|Lean mass and fat mass: measurements of body composition assessed using Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.|||||
167027|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor Binding Protein 3 (IGFBP3) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|Data were collected and reported in individual participant listing but not statistically summarized due to early termination of the study.|||||
167028|NCT00174291|Secondary|Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Concentration at Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5 and 9||Baseline, Year 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.||milligram per deciliter (mg/dL)||Full Range|Median
167029|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Final Height|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
167030|NCT00174291|Primary|Change From Baseline in Predicted Height Standard Deviation Score (SDS) at Year 3|Predicted height was calculated according to Greulich and Pyle using Bayley Pinneau method. Predicted height SDS was obtained by calculating the predicted height, subtracting chronological age- and gender-appropriate mean predicted height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
167031|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
167032|NCT00174291|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|FAS included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
167033|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Final Height|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, final height (assessed up to Year 9.5)|Data was not analyzed because of change in planned analysis after early termination of the study.|||||
167487|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Collum Femoris After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMD||Full Range|Median
167034|NCT00174291|Primary|Change From Baseline in Annual Rate of Growth Standard Deviation Score (SDS) at Year 3|Annual rate of growth SDS was obtained by measuring the annual growth rate, subtracting chronological age- and gender-appropriate mean annual growth rate and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) included all participants who received at least 1 dose of study treatment and had at least 1 post-baseline height measurement. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Full Range|Median
167035|NCT00174265|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.|Baseline of A7501013 to Day 365|ITT population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the MMRM model.||Units on a Scale||Standard Error|Least Squares Mean
167036|NCT00174265|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.|Baseline of A7501013 to Day 365|Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model.||Units on a Scale||Standard Error|Least Squares Mean
167037|NCT00174252|Secondary|IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.||ratio||Standard Deviation|Mean
167038|NCT00174252|Secondary|IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months||12 and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1/IGFBP-3 data at 12 and 24 months.||ratio||Standard Deviation|Mean
167039|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 – reference mean) / reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.||SD||Standard Deviation|Mean
167040|NCT00174252|Secondary|Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD|6, 9, 12, 15, 18, 21, and 24 months|SAS. Number of Participants Analyzed = Number of children treated. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable IGF-1 SD data at 6, 9, 12, 15, 18, 21, and 24 months.||SD||Standard Deviation|Mean
167041|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable BA/CA data at 12 and 24 months.||ratio||Standard Deviation|Mean
167042|NCT00174252|Other Pre-specified|BA/CA at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|The BA/CA ratio was calculated at Screening, 12 and 24 months. The CA was the age on the date that the corresponding BA X-ray was performed.|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable BA/CA data at 12 and 24 months.||ratio||Standard Deviation|Mean
167043|NCT00174252|Other Pre-specified|Change in BA From Baseline at 12 and 24 Months|Change in BA was calculated as: (12 or 24 months minus Screening)|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable BA data at 12 and 24 months.||year||Standard Deviation|Mean
167044|NCT00174252|Secondary|ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (BA) at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 24 months.||SD for BA||Standard Error|Mean
167045|NCT00174252|Secondary|ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (BA) was calculated as:~Height SD (BA) at 12 months minus Height SD (BA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD BA data at 12 months.||SD for BA||Standard Error|Mean
167046|NCT00174252|Secondary|ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|Height SD (CA) at 24 months.|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 24 months.||SD for CA||Standard Error|Mean
167047|NCT00174252|Secondary|Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months|"Change in Height SD (CA) was calculated as:~Height SD (CA) at 12 months minus Height SD (CA) at Baseline"|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months or with IGF-1 > 2 SD at 9 and 12 months and with evaluable height SD CA data at 12 months.||SD for CA||Standard Error|Mean
167219|NCT00168844|Secondary|Change From Baseline in VPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
167049|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 12 months. n = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD BA data at 24 months.||SD for BA||Standard Deviation|Mean
167050|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 24 months.||SD for BA||Standard Deviation|Mean
167051|NCT00174252|Secondary|Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD BA data at 12 months.||SD for CA||Standard Deviation|Mean
167052|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable growth rate SD CA data at 12 and 24 months.||SD for CA||Standard Deviation|Mean
167053|NCT00174252|Secondary|Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months~Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 12 months. n = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable growth rate SD CA data at 24 months.||SD for CA||Standard Deviation|Mean
167054|NCT00174252|Other Pre-specified|Growth Rate at 12 and 24 Months|"Growth Rate was calculated at 12 months as:~(Height at 12 months minus Height at Day 0) divided by {(Date of 12 months minus Date of Day 0) divided by 365.25}~Growth Rate was calculated at 24 months as:~(Height at 24 months minus Height at 12 months) divided by {(Date of 24 months minus Date of 12 months) divided by 365.25}"|12 and 24 months|FAS. Number of Participants Analyzed = Number of children treated. n = Number of children with evaluable growth rate data at 12 and 24 months.||cm/year||Standard Deviation|Mean
167055|NCT00174252|Secondary|Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 or 24 months” minus height in SD at “Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 or 12 months with evaluable height SD BA data at 12 and 12 months.||SD for BA||Standard Deviation|Mean
167056|NCT00174252|Secondary|Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “24 months” minus height in SD at “Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 24 months.||Height in SD||Standard Deviation|Mean
167057|NCT00174252|Secondary|Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 months” minus height in SD at Baseline."|Baseline, 12 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD BA data at 12 months.||SD for BA||Standard Deviation|Mean
167058|NCT00174252|Secondary|Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “12 or 24 months” minus height in SD at “Baseline."|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 > 2 SD at 9 and 12 months with evaluable Height SD CA data at 12 and 24 months.||SD for BA||Standard Deviation|Mean
167059|NCT00174252|Secondary|Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at “24 months” minus height in SD at Baseline."|Baseline, 24 months|FAS. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 24 months.||SD for CA||Standard Deviation|Mean
167060|NCT00174252|Secondary|Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months|"The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at 12 months” minus height in SD at Baseline."|Baseline, 12 months|The full analysis set (FAS) included all patients who received at least one dose of assigned treatment and had at least one subsequent rating of IGF-1. Number of Participants Analyzed = Number of children with IGF-1 < = 2 SD at 9 or 12 months with evaluable height SD CA data at 12 months.||SD for CA||Standard Deviation|Mean
167061|NCT00174252|Primary|Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months|Percentage of children with serum IGF-1 > 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.|9 and 12 months|The safety analysis set (SAS) was defined as all patients who received at least one dose of GH treatment. Number of Participants Analyzed = Number of children treated.||percentage of participants|||Number
167062|NCT00174252|Other Pre-specified|Change in Height From Baseline|The standing height measurements were performed at the same time of the day by using a wallmounted device (e.g. Harpenden Stadiometer) at each study visit. The pre-specified clinical outcomes were analyzed at 12 and 24 months.|Baseline, 12 and 24 months|FAS. Number of Participants Analyzed = Number of children with evaluable height data at 12 and 24 months.||centimeters (cm)||Standard Deviation|Mean
167063|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration After Year 3||Year 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10; 0.5 and 1 year after somatropin discontinuation, Final Height (assessed up to Year 11)|FAS After year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.||milligram per deciliter (mg/dL)||Full Range|Median
167064|NCT00174187|Other Pre-specified|Insulin-like Growth Factor-1 (IGF-1) Concentration up to Year 3||Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||nanogram per milliliter (ng/mL)||Full Range|Median
167065|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Bone Age (GV [SDS/BA])|GV measures the annual rate of increase in height. GV (SDS/BA) was obtained by measuring GV, subtracting the bone age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from bone age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167066|NCT00174187|Other Pre-specified|Growth Velocity Standard Deviation Score According to Chronological Age (GV [SDS/CA])|GV measures the annual rate of increase in height. GV (SDS/CA) was obtained by measuring GV, subtracting the chronological age- and gender-appropriate mean GV and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167067|NCT00174187|Other Pre-specified|Growth Velocity (GV)|Growth velocity measures the annual rate of increase in height.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||cm/year||Inter-Quartile Range|Median
167068|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Tanner Puberty Stage (BMC [TB] [SDS/Tanner Puberty Stage])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/Tanner Puberty Stage) was obtained by measuring BMC (TB), subtracting the Tanner puberty stage- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167069|NCT00174187|Secondary|Bone Mineral Content Standard Deviation Score of Total Body According to Chronological Age (BMC [TB] [SDS/CA])|BMC (TB) was measured by DEXA scan. BMC (TB) (SDS/CA) was obtained by measuring BMC (TB), subtracting the chronological age- and gender-appropriate mean BMC (TB) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167070|NCT00174187|Secondary|Percent Change From Baseline in Bone Mineral Content of Total Body (BMC [TB]) at Year 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Percent change: (BMC [TB] at Year 3 minus BMC [TB] at baseline) divided by BMC [TB] at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Inter-Quartile Range|Median
167071|NCT00174187|Secondary|Annual Percent Change in Bone Mineral Content of Total Body (BMC [TB]) at Year 1, 2 and 3|BMC is an estimate of the amount of mineral (such as calcium) in the bone. Annual percent change: (BMC [TB] at current year minus BMC [TB] at previous year) divided by BMC [TB] at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percent change||Inter-Quartile Range|Median
167220|NCT00168844|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
167072|NCT00174187|Secondary|Bone Mineral Content of Total Body (BMC [TB])|DEXA scan of BMC was used to evaluate potential bone effects of treatment. BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||gram||Inter-Quartile Range|Median
167073|NCT00174187|Secondary|Bone Mineral Density of Lumbar Spine (BMD [LS])|BMD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||g/cm^2||Inter-Quartile Range|Median
167074|NCT00174187|Secondary|Bone Mineral Density of Total Body (BMD [TB])|BMD (TB) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||gram per square centimeter (g/cm^2)||Inter-Quartile Range|Median
167075|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumber Spine According to Tanner Puberty Stage (BMAD [LS] [SDS/Tanner Puberty Stage])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/Tanner Puberty Stage) was obtained by measuring BMAD (LS), subtracting Tanner puberty stage- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from Tanner puberty stage- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167076|NCT00174187|Secondary|Apparent Bone Mineral Density Standard Deviation Score of Lumbar Spine According to Chronological Age (BMAD [LS] [SDS/CA])|BMAD (LS) was assessed by DEXA scan. BMAD (LS) (SDS/CA) was obtained by measuring the BMAD (LS), subtracting chronological age- and gender-appropriate mean BMAD (LS) and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167077|NCT00174187|Secondary|Apparent Bone Mineral Density of Lumbar Spine (BMAD [LS])|BMAD (LS) was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||gram per cubic centimeter (g/cm^3)||Inter-Quartile Range|Median
167078|NCT00174187|Secondary|Fat Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Fat mass was assessed by DEXA scan. Fat mass SDS/CA was obtained by measuring fat mass, subtracting chronological age- and gender-appropriate mean fat mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167079|NCT00174187|Secondary|Fat Mass as Percentage of Total Weight|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percentage of total weight||Inter-Quartile Range|Median
167080|NCT00174187|Secondary|Percent Change From Baseline in Fat Mass at Year 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Fat mass at Year 3 minus fat mass at baseline) divided by fat mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Inter-Quartile Range|Median
167081|NCT00174187|Secondary|Annual Percent Change in Fat Mass at Year 1, 2 and 3|Fat mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Fat mass at current year minus fat mass at previous year) divided by fat mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percent change||Inter-Quartile Range|Median
167082|NCT00174187|Secondary|Fat Mass|Fat mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||kg||Inter-Quartile Range|Median
167242|NCT00168831|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
167083|NCT00174187|Secondary|Lean Body Mass Standard Deviation Score According to Chronological Age (SDS/CA)|Lean body mass was assessed by DEXA scan. Lean body mass SDS/CA was obtained by measuring lean body mass, subtracting the chronological age- and gender-appropriate mean lean body mass and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||SDS||Inter-Quartile Range|Median
167084|NCT00174187|Secondary|Lean Body Mass as Percentage of Total Weight|Lean body mass, a measurement of body composition, was assessed by DEXA scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percentage of total weight||Inter-Quartile Range|Median
167085|NCT00174187|Secondary|Percent Change From Baseline in Lean Body Mass at Year 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Percent change: (Lean body mass at Year 3 minus lean body mass at baseline) divided by lean body mass at baseline, multiplied by 100.|Baseline, Year 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||percent change||Inter-Quartile Range|Median
167086|NCT00174187|Secondary|Annual Percent Change in Lean Body Mass at Year 1, 2 and 3|Lean body mass, a measurement of body composition, was assessed by DEXA scan. Annual percent change: (Lean body mass at current year minus lean body mass at previous year) divided by lean body mass at previous year, multiplied by 100.|Baseline, Year 1, 2, 3|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||percent change||Inter-Quartile Range|Median
167087|NCT00174187|Secondary|Lean Body Mass|Lean body mass, a measurement of body composition, was assessed by Dual Energy X-ray Absorptiometry (DEXA) scan.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at the given time point for each group respectively.||kilogram (kg)||Inter-Quartile Range|Median
167088|NCT00174187|Secondary|Bone Age|Bone age was determined by the Greulich and Pyle method using left wrist and hand X-ray.|Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS up to Year 3: included all participants who had at least one post-baseline height measurement and were treated with the study drug for at least 1 year. Here, 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.||years||Inter-Quartile Range|Median
167089|NCT00174187|Primary|Puberty Stage at Final Height|Pubertal stage (graded from I to V for breast development and pubic hair development) according to the Tanner's method was collected. A low stage (Stage I) corresponds to a pre-pubertal stage and a high stage (Stage V) to an adult stage.|When final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of study treatment and who had at least one post-baseline height measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants who were evaluable for given components of puberty assessment.||participants|||Number
167090|NCT00174187|Primary|Change From Baseline in Weight Standard Deviation Score (SDS) at Final Height|Body weight was measured using a balance scale. Weight SDS was obtained by measuring the weight, subtracting age- and gender-appropriate mean weight and dividing the result by standard deviation of that mean (as obtained from age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least one dose of the study treatment and who had at least one post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time point.||SDS||Full Range|Median
167091|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Final Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, when final height was reached (assessed up to Year 11)|FAS- after Year 3: included all participants who received at least 1 dose of the study treatment and who had at least 1 post-baseline height measurement. Here, 'n' signifies those participants who were evaluable for this measure at given time points.||SDS||Full Range|Median
167092|NCT00174187|Primary|Change From Baseline in Height Standard Deviation Score According to Chronological Age (SDS/CA) at Year 3|Height was measured using a wall mounted device (example, Harpenden stadiometer). Height SDS/CA was obtained by measuring the height, subtracting chronological age- and gender-appropriate mean height and dividing the result by standard deviation of that mean (as obtained from chronological age- and gender-specific population reference data). SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) participant’s value was relative to the mean of the reference population.|Baseline, Year 3|Full Analysis Set (FAS) up to Year 3: included all participants who had at least 1 post-baseline height measurement and were treated with the study drug for at least 1 year.||Standard Deviation Score (SDS)||Inter-Quartile Range|Median
167221|NCT00168844|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
167093|NCT00172042|Primary|Percentage of Participants With Progression-Free Survival Events|Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants|||Number
167094|NCT00172042|Primary|Kaplan-Meier Estimates for Progression-free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants||95% Confidence Interval|Number
167095|NCT00172042|Secondary|Kaplan-Meier Estimates for Overall Survival||Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants||95% Confidence Interval|Number
167096|NCT00172042|Secondary|Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)|Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event|Months 6,12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant in whom no SRE had been observed during the study was to be censored at the date of the last visit or the date of death whichever was the earlier.||Percentage of participants||95% Confidence Interval|Number
167097|NCT00172042|Secondary|Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry|Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.|Months 12 and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants|||Number
167098|NCT00172042|Secondary|Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases|Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18, and 24|Intent-to-Treat Population consisting of all randomized participants. Any participant without documented bone metastases at the date of analysis was to be censored at the date of the last bone scan.||Percentage of participants||95% Confidence Interval|Number
167099|NCT00172042|Secondary|Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months|Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).|Months 6, 12, 18 and 24|Intent-to-Treat Population consisting of all randomized participants.||Percentage of participants|||Number
167100|NCT00172042|Primary|Progression-Free Survival|Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.|Up to 24 months|Intent-to-Treat Population consisting of all randomized participants.||Months||95% Confidence Interval|Median
167101|NCT00171925|Secondary|The Number of Participants With the Development of Skeletal Complications|"Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline~Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography~Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression~Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression~Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl"|48 months|Intent to treat population||Participants|||Number
167102|NCT00171925|Secondary|Number of Patients With Progression by Individual Criteria|Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon & Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.|48 months|Intent to Treat Population||Participants|||Number
167103|NCT00171925|Primary|Days of Progression Free Survival|"Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events:~progression to stage II or III according to Salmon & Durie classification~skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia)~unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically."|48 months|Intent to Treat Population||Days||Standard Error|Mean
167104|NCT00171873|Secondary|Survival||at least on a monthly basis||12/2014||||
167105|NCT00171873|Secondary|Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study||at three-month intervals||12/2014||||
167106|NCT00171873|Secondary|Symptom Control at 3 Month Intervals||at 3 month intervals up to 18 moths||12/2014||||
167107|NCT00171873|Secondary|Biochemical Response at 3 Month Intervals||at 3 month intervals up to 18 moths||12/2014||||
167108|NCT00171873|Secondary|Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals||at 3 month intervals||12/2014||||
167109|NCT00171873|Primary|Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)|Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.|Up to 7 years|Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.||Months||95% Confidence Interval|Median
167110|NCT00171834|Secondary|Duration of Overall Response -Phase I and Phase II|Duration of overall response (CR or PR) measured by RECIST was measured from the first documented CR or PR to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Duration of response according to RECIST from start of study until study discontinuation. Duration of response was assessed every second cycle ( i.e. approximately every 6 weeks) until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
167111|NCT00171834|Secondary|Time to Overall Response -Phase I and Phase II|Time to overall response (CR or PR) measured by RECIST was the time between study start until date of first documented response (CR or PR).|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
167112|NCT00171834|Secondary|Duration of Stable Disease-Phase I and Phase II|Duration of stable disease (CR, PR, or SD) by RECIST was defined as the time from start of study drug to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.|Imaging was assessed every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from treatment . Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
167113|NCT00171834|Primary|Phase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Overall response is the number of participants who had a complete response (CR) or a partial response (PR) based on local investigator’s assessment of RECIST criteria. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|At baseline, then every second cycle (approximately every 6 weeks), until disease progression or discontinuation. Average 18 weeks.|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Participants|||Number
167114|NCT00171834|Primary|Phase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of patupilone administered every three weeks (q3w) where not more than one out of six patients experienced a DLT using a standard 3+3 design. Dose escalation started at 6.5 mg/m^2 until MTD in steps of 0.5 mg/m^2 until 12 mg/m^2, then in steps of 1 mg/m^2 till 13.0 mg/m^2. DLTs were assessed during cycle 1. During this time frame, no more than one DLT occurred in any of the explored dose levels up to 13 mg/m^2, thus, the MTD as defined by the protocol was not reached in this study.|Cycle 1 (21 days)|Maximum tolerated dose (MTD) determining population.included all patients who completed the first treatment cycle (Cycle 1) according to protocol or discontinued due to a DLT. The first cycle data from this patient population were used to determine the MTD in the Phase I part of the study.||Dose Limiting Toxicity (DLT)|||Number
167115|NCT00171834|Secondary|Time to Progression (TTP)-Phase I and Phase II|Time to progression was measured from the start of study drug to the date of first documented disease progression by RECIST, discontinuation due to disease progression, or death from underlying cancer, whichever event occurred first. If a patient had not progressed by RECIST, discontinued due to disease progression, or died from underlying cancer, TTP was censored at the time of last adequate tumor assessment. However, if a patient took any new cancer therapy prior to PD or death, then TTP was censored at the date of last adequate tumor assessment prior to the start date of new cancer therapy.|From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
167116|NCT00171834|Secondary|Overall Survival Time-Phase I and Phase II|Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Data was collected post treatment every 3 months until approximately 70% of patients have reached the survival endpoint (Phase I + Phase II).|From start of study drug to date of death due to any cause. Follow-up after treatment discontinuation approximately every 3 months until approximately 70% of participants have reached the survival endpoint. Average 9.75 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Months||95% Confidence Interval|Median
167139|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level Measured From Core Study Baseline (BL) to End of Extension Study|Serum Levels were assessed at core study baseline (BL), 1 year, 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study) in monthly intervals. Serum Ferritin is reported in micrograms per Liter (µg/L).|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study.||µg/L||Standard Deviation|Mean
167117|NCT00171834|Secondary|Number of Participants With Best Overall Response-Phase I|This was defined as the number of participants whose best overall response was CR or PR by RECIST. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.|Best achieved overall response according to RECIST from start of study until study discontinuation. Imaging was assessed every second cycle (ie. approximately every 6 weeks) until disease progression or discontinuation. Average 18 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of patupilone. Analysis of the primary and all secondary efficacy endpoints was performed based on this population. According to the Intention to Treat (ITT) principle, patients were analyzed based on the treatment to which they were assigned at study entry.||Participants|||Number
167118|NCT00171704|Secondary|Time to Overall Survival Events|Overall survival was measured from date of randomization to date of death.|60 Months|All randomized patients constituted the ITT Population, unless withdrawal of consent occurred after randomization but before the start of study treatment assigned.||days||Inter-Quartile Range|Median
167119|NCT00171704|Secondary|Time to Disease Recurrence or Death|Disease-free survival was defined as the interval between randomization and earliest confirmed event of loco-regional recurrence, distant metastases, invasive contralateral breast cancer, or death from any cause.|60 months|Analysis of disease-free survival was based on the ITT principle, with all enrolled (and randomized) patients included. The Kaplan-Meier product-limit approach was used.||Days||Inter-Quartile Range|Median
167120|NCT00171704|Secondary|Number of Participants With Clinically Relevant Changes From Baseline in Cholesterol|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. Numbers are not additive, as patients could be included in multiple rows.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients with pre-defined clinically relevant changes in serum lipids over the course of 5 years in each treatment arm is presented.||Participants|||Number
167121|NCT00171704|Secondary|Percentage Change From Baseline in Serum Lipids at 5 Years|Serum lipid profile (fasting serum cholesterol [total, HDL and calculated LDL], triglycerides, and lipoprotein [a]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of serum lipids was on the treatment group median percent change from baseline (and range) at 5 years.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis.||Percent Change||Full Range|Median
167122|NCT00171704|Secondary|Median Percent Change From Baseline of Serum Markers of Bone Turnover|Bone turnover markers (fasting serum procollagen-I extension peptide [P1NP], C-telopeptide [CTX], skeletal bone-specific alkaline phosphatase [BSAP, N-telopeptide [NTX]) were measured at baseline/screening and at each visit thereafter. A central laboratory was used to analyze the samples. The analysis of bone markers was based on analysis of variance of the regression slopes calculated for each individual patient and each bone marker over time. In the following summary, only the median treatment group percent change from baseline (and range) at 5 years is presented for each bone marker.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. During different time points, participants with observations at that time point were included in the analysis. The analysis of bone markers over time consisted of patients with measurements of specific markers at each time point.||Percent Change||Full Range|Median
167123|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density (BMD) of Total Hip|Total hip BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis of BMD at 5 years included all patients enrolled with centrally assessed measurements of total hip BMD.||Percent Change||Full Range|Median
167124|NCT00171704|Secondary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine|Lumbar spine (L2-L4)BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 60 months|The safety population consisted of only patients who took randomized therapy for at least one day. The analysis at 5 years included all patients enrolled and who had centrally assessed measurements of lumbar spine and/or total hip BMD.||Percent change||Full Range|Median
167125|NCT00171704|Primary|Percent Change From Baseline of Bone Mineral Density of the Lumbar Spine (L2-l4)|Lumbar spine (L2-L4) BMD measurements by dual energy X-ray absorptiometry (DXA) were performed after surgery and within 2 weeks prior to randomization and repeated every 6 months for the first 2 years and annually thereafter until 5 years after enrollment. The primary scanning site was the lumbar spine (L2 to L4) and the secondary scanning site was the total hip. All DXA scans were evaluated by a central reader.|Baseline, 24 months|The safety population consisted of only patients who took randomized therapy for at least one day. The number of patients in each treatment arm who had completed 2 years of the study and had centrally assessed measurements of lumbar spine or total hip BMD.||Percent Change||Full Range|Median
167126|NCT00172185|Secondary|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use|Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)|6 months|Response Status is Yes or No||participants|||Number
167181|NCT00168844|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.~Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
167127|NCT00172185|Primary|Number of Subjects Achieving a 20% Reduction at Week 28|"For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use.~For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use."|28 weeks|Number of participants for analysis was determined based on completing all of the prerequisite visits in Study 005. Subjects who dropped out of the study were considered failures.||Participants|||Number
167128|NCT00171340|Secondary|Percentage of Participants With Clinical Fractures at 3 Years of Therapy Which Were Not Present at Baseline|At 3 years of therapy the percentage of participants with fractures as detected by X-ray and/ or bone scan.|Baseline,3 years|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.||Percentage of Participants|||Number
167129|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Total Hip at 12 Months, 2 Years, 3 Years, 4 Years and 5 Years After Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 12 months. Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.||Percentage change in BMD||Standard Deviation|Mean
167130|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD)of the Lumbar Spine (L1-L4) Over 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L1-L4)as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.||Percentage change in BMD||Standard Deviation|Mean
167131|NCT00171340|Secondary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 2, 3, 4 and 5 Years of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by dual energy x-ray absorptiometry (DXA)|Baseline, 2 years. Baseline, 3 years. Baseline, 4 years. Baseline, 5 years.|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication. n in each of the categories is the number of participants who had safety data at baseline and the given time point.||Percentage change in BMD||Standard Deviation|Mean
167132|NCT00171340|Primary|Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.|Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).|Baseline, 12 months|The Safety Population consists of all Randomized Patients who received at least 1 dose of study medication.||Percentage change in BMD||Standard Deviation|Mean
167133|NCT00171314|Secondary|Percentage of Participants With Radiological (Vertebra) Fractures Which Were Not Present at Baseline But Were Present at Year 3|Radiological Fracture at 36 months which was not present at baseline = (new fracture/number participant analyzed)*100. Evaluation of radiological fractures were based on central lab X-ray data. A subject with multiple fractures at the same time or multiple fractures with the same grade is counted only once for that treatment.|Year 3|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at Year 3 were included in this analysis.||Percentage of Participants|||Number
167134|NCT00171314|Secondary|Percent Change in Total Hip BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. During different time points, participants with observations at that time point were included in the analysis.||Percent Change||Standard Deviation|Mean
167135|NCT00171314|Secondary|Percent Change in Lumbar Spine (L1-L4) BMD at Year 1, Year 2, Year 3, Year 4 and Year 5|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 1, Year 2, Year 3, Year 4, Year 5|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization.||Percent Change||Standard Deviation|Mean
167136|NCT00171314|Secondary|Percent Change in Lumbar Spine (L2-L4) BMD at 2 Years, 3 Years, 4 Years and 5 Years|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline to Year 2, Year 3, Year 4, Year 5|"Analysis of safety:safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. n in each category indicates participants with data at baseline and each corresponding timepoint."||Percent Change||Standard Deviation|Mean
167137|NCT00171314|Primary|Percent Change in Lumbar Spine (L2-L4) BMD After 12 Months of Letrozole Therapy|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|From Baseline - 12 months|For the analysis of safety, the safety population for treatment arms were defined by the actual treatment received, rather than the treatment arm assigned by randomization. Participants with observations at baseline and 12 months were included in this analysis.||Percent Change||Standard Deviation|Mean
167138|NCT00171301|Secondary|Absolute Change in Serum Ferritin Level for All Participants Measured From Core Study Baseline (BL) to End of Extension Study, by Baseline Liver Iron Content (LIC)|Serum Levels were assessed at core study baseline (BL) and then 1 year and 2 years in core study, baseline of extension study and time of discontinuation from the extension visit (end of study). Serum Ferritin is reported in micrograms per Liter. Absolute change in Serum Ferritin from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw.|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom Serum Ferritin data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.||µg/L||Standard Deviation|Mean
167271|NCT00168831|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167140|NCT00171301|Primary|Absolute Change in Liver Iron Concentration (LIC)Measured by Liver MRI or Liver Biopsy From Core Study Baseline (BL) to End of Extension Study, by LIC Category|"Liver MRI or Liver Biopsy was performed at the core study baseline (BL) and then 1 year and 2 years in the core study, baseline of the extension study and time of discontinuation from the extension visit (end of study). Liver iron content (LIC) is reported in milligram Iron per gram dry weight (mg Fe/g dw).~Absolute change in LIC from core study baseline to the end of the extension study is presented for participants with the following two core study baseline LIC levels: 1-<7 mg Fe/g dw and ≥7 mg Fe/g dw."|From Baseline of Core Study to End of Extension Study, up to 3 years|Participants from the Intent-to-Treat (ITT) population for whom LIC data was available at Core Study baseline and at the End of Extension Study. “n” is the number of participants analyzed in each category.||mg Fe/g dw||Standard Deviation|Mean
167141|NCT00171301|Primary|Percentage of Participants With Treatment Success From Core Baseline (BL) to Extension End of Study, by Baseline LIC Level and Age|Success was defined as the percentage of participants with decreased liver iron content (LIC) at the end of extension study compared to core baseline (BL) LIC. Success Criteria: For participants with Baseline LIC from 1 - <7 mg Fe/g dw, success was achieved if LIC level maintained at 1 - <7 mg Fe/g dw. For participants with Baseline LIC ≥7 - <10 mg Fe/g dw, success was achieved if LIC dropped to between 1 and < 7 mg Fe/g dw. For participants with Baseline LIC ≥10 mg Fe/g dw, success was achieved if LIC dropped by at least 3 mg Fe/g dw. LIC was measured by biopsy or magnetic resonance imaging.|From Core Study Baseline, to Extension End of Study, Up to 3 Years|The primary analysis will be on the intent-to-treat (ITT) population. ITT population includes all participants who performed the core end of study (EOS) visit evaluation and assessments and were included in the extension study. “n” is the number of participants analyzed in each category.||percentage of participants||95% Confidence Interval|Mean
167142|NCT00171210|Secondary|Change of Total Body Iron Excretion Rate (TBIE) From Start of ICL670 Treatment to the End of Study|Median change in TBIE (mg/kg/day) from start of treatment with Deferasirox (ICL670) to end of study.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||mg/kg/day||Full Range|Median
167143|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study as Measured by SQUID|Relative change in liver iron content (LIC) measured by Superconducting Quantum Interfering Device (SQUID), calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.||percent of start value||Full Range|Median
167144|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID|Measurement of the median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through Superconducting Quantum Interfering Device (SQUID). Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Full Range|Median
167145|NCT00171210|Secondary|Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Relative change in liver iron content (LIC) as measured by biopsy and calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.||percent of start value||Full Range|Median
167146|NCT00171210|Secondary|Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy|Measurement of median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through biopsy. Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Full Range|Median
167147|NCT00171210|Secondary|Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate marker: Transferrin Saturation (Percent) from start of treatment with Deferasirox (ICL670) to end of study.~(Transferrin Saturation at the End of Study-Tranferrin Saturation at Start of ICL670)/Transferrin Saturation at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Percent change||Standard Deviation|Mean
167182|NCT00168844|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Puffs||Standard Error|Mean
167488|NCT00165698|Primary|Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months||Baseline and 12 months|Per Protocol Set (PPS)||percentage of BMD||Full Range|Median
167148|NCT00171210|Secondary|Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change of potential surrogate markers: Serum Iron (µmol/L) from start of treatment with Deferasirox (ICL670) to end of study.~(Serum Iron at the End of Study-Serum Iron at Start of ICL670)/Serum Iron at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Percent change||Standard Deviation|Mean
167149|NCT00171210|Secondary|Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study|"Measurement of the relative change in percent of potential surrogate marker: Serum Transferrin (g/L) from start of treatment with Deferasirox (ICL670) to end of study.~(Serum Transferrin at the End of Study-Serum Transferrin at Start of ICL670)/Serum Transferrin at Start of ICL670*100."|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Percent change||Standard Deviation|Mean
167150|NCT00171210|Secondary|Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study|Mean Absolute Change in serum ferritin (ug/L) from start of treatment with Deferasirox (ICL670) to end of study taking into account the therapeutic goal which will either be to maintain iron balance or to induce negative iron balance. End of study taken as the mean of, at most, the last three available results after start of treatment with ICL670.|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||μg/L||Standard Deviation|Mean
167151|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID|Mean absolute change in LIC from start of Deferasirox (ICL670) treatment to the end of the study assessed by Superconducting Quantum Interfering Device (SQUID) measurement used as a non-invasive alternative to Biopsy for pediatric participants. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Standard Deviation|Mean
167152|NCT00171210|Secondary|Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy|Mean absolute change of LIC from start of Deferasirox (ICL670) treatment to the end of study assessed by liver biopsy. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw).|Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years)|Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study.||mg Fe/g dw||Standard Deviation|Mean
167153|NCT00171210|Primary|Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event|Adverse events results are based on preferred terms with at least 7% of participants in any group.|up to 5 years|All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension.||Participants|||Number
167154|NCT00171054|Secondary|Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38|Central Blood Pressure was measured via applanation tonometry recordings of the common carotid artery and from brachial oscillometric recordings. The Simultaneously obtained carotid artery pressure and standard brachial artery blood pressure are computed to obtain the central systolic pressure.|Baseline, Week 12 and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||mm Hg||Standard Error|Least Squares Mean
167155|NCT00171054|Secondary|Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38||Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
167156|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||EP||Standard Error|Least Squares Mean
167183|NCT00168844|Secondary|Weekly Mean Evening PEFRs|Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
167184|NCT00168844|Secondary|Weekly Mean Morning Pre-dose PEFRs|Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Litres/minute||Standard Error|Mean
167157|NCT00171054|Secondary|Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12|The calculation of spontaneous baroflex sensitivity was obtained by the sequence method. Baroflex sequences are defined by at least three consecutive beats in which the systolic blood pressure and the RR interval of the following beat either both increased or decreased. The slope of each individual sequence is computed and the mean slope is determined as the average of all slopes within a given period of time and taken as the gain of the cardiac baroflex (BRSs).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||EP||Standard Error|Least Squares Mean
167158|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
167159|NCT00171054|Secondary|Changes in Mean Right Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
167160|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 38|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
167161|NCT00171054|Secondary|Changes in Mean Left Carotid Distensibility at Week 12|For carotid distensibility, the left and right bulbs and common carotid arteries are measured using tissue Doppler imaging with the linear array probe. Absolute diameter and diameter changes over the cardiac cycles will be recorded. Distensibility of each bulb will be calculated for three consecutive heart cycles and averaged and corrected for blood pressure.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
167162|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
167163|NCT00171054|Secondary|Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12|Endothelial function will be assessed using high-resolution duplex ultrasound with wall tracking to measure FMD of the brachial artery during reactive hyperemia. FMD of the brachial artery in response to reactive hyperemia in the distal forearm (and glyceryl trinitrate as a non-endothelium dependent control) will be measured from B-mode ultrasound images using a standard 7 MHz linear array transducer and HDI 5000 system with edge detection.|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||percent||Standard Error|Least Squares Mean
167164|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||Perfusion units||Standard Error|Least Squares Mean
167165|NCT00171054|Secondary|Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12|Cutaneous blood flow was continuously recorded by a laser Doppler flowmeter. The laser Doppler flow probe was applied on the volar part of the right forearm with a plastic holder 10 cm proximal to the wrist. All measurements were made with a pressure cuff on the arm and inflated 20 mmHg above systolic BP and maintained for 2 min then rapidly deflated. All measurements were made in a quiet room with a patient in the supine position. The maximal reactive hyperemia was measured after cuff deflation, which allows measurement of the right forearm postischemic skin reactive hyperemia (SRH).|Baseline and Week 12|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||Perfusion units||Standard Error|Least Squares Mean
167213|NCT00168844|Secondary|Change From Baseline in Platelets|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167214|NCT00168844|Secondary|Change From Baseline in White Blood Cell Count|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/Litre (L)||Standard Deviation|Mean
167166|NCT00171054|Primary|Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)|PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t.|Baseline and Week 38|Intent-to-treat. The intent to treat population is defined as those who provide a baseline measure and at least one post-baseline measurement (not necessarily an endpoint measure)||m/s||Standard Error|Least Squares Mean
167167|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke|CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes.|For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group||Percentage of Patients with an Event|||Number
167168|NCT00170950|Secondary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event|Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).|For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]|Intent-to-treat population: All randomized patients by assigned treatment group||Percentage of Patients with an Event|||Number
167169|NCT00170950|Primary|Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event|CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes.|For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])|Intent-to-treat population: All randomized patients by assigned treatment group||Percentage of Patients with an event|||Number
167170|NCT00170846|Secondary|Number of Participants With Safety Parameters|The selected safety parameters (such as hypertension, hyperlipidemia, diabetes mellitus, anemia, malignancies ) were derived based on adverse events preferred terms defined in the analysis plan.|24 months|Safety Population. The Safety Population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment.||Participants|||Number
167171|NCT00170846|Post-Hoc|Change in mGFR by Baseline Calculated Creatinine Clearance (Cockcroft-Gault Formula)|"Cockcroft-Gault formula (CrCl):~Creatinine Clearance [mL/min] = CrCl (males) = (140 – A) * W / (72 * C) (males), CrCl (females) = CrCl (males) * 0.85,~Where:~A is age [years]~W is body weight [kg]~C is the serum concentration of creatinine [mg/dL]"|Baseline and 24 months|Per Protocol Population. The per-protocol (PP) population consisted of the ITT patients excluding those patients with major protocol deviations and those patients who were not able to initiate their randomized regimens as scheduled.||mL/min||Standard Deviation|Mean
167172|NCT00170846|Primary|Renal Function Assessed by Measured GFR (mGFR)|The acceptable methods for GFR measurement were Chromium 51-Ethylenediaminetetra acetic acid (Cr-EDTA), Technetium 99-Diethylenetriaminepentacetic acid (Tc-DTPA), Iohexol clearance Inuline clearance and Iothalamate clearance. The method should have been consistent for a given patient at every time point.|24 months|The modified ITT population included all ITT patients who had mGFR or calculated GFR (cGFR) at Month 24 based on all values including those collected after discontinuation of study medication.||mL/min/1.73m^2||Standard Deviation|Mean
167173|NCT00170625|Secondary|Progression-free Survival|progression-free survival according to kaplan-meier-estimator|after every third cycle, for up to one year|||months||95% Confidence Interval|Median
167174|NCT00170625|Primary|Toxicity|hematological adverse events and non-hematological adverse events grade 3/4|after each cycle for up to one year|||participants|||Number
167175|NCT00170157|Secondary|Number of Participants With an Initial Prostate-specific Antigen (PSA) Response|Initial PSA response is defined as the response to the initially assigned treatment (prior to crossing over). A response is defined as a decrease in PSA 50% or greater that is confirmed 2 consecutive measurements taken at least 2 weeks apart.|Duration of study (up to 18 months)|Data has not been and will never be analyzed. Results will not be posted.|||||
167176|NCT00170157|Primary|Number of Participants Progression-free at 18 Months|PSA progression is defined as a rise in PSA to >4.0 ng/mL demonstrated twice in measurements taken two weeks apart.|18 months from the start of AA therapy|||participants|||Number
167177|NCT00168844|Secondary|PGR Score|"Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)||Points on a scale||Standard Error|Mean
167178|NCT00168844|Secondary|PGE Scores|"Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)||Points on a scale||Standard Error|Mean
167179|NCT00168844|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)||Points on a scale||Standard Error|Mean
167180|NCT00168844|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
167185|NCT00168844|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167186|NCT00168844|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167187|NCT00168844|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167188|NCT00168844|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167189|NCT00168844|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||g/L||Standard Deviation|Mean
167190|NCT00168844|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
167191|NCT00168844|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
167192|NCT00168844|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
167193|NCT00168844|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||micromoles per litre (umol/L)||Standard Deviation|Mean
167194|NCT00168844|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
167195|NCT00168844|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
167196|NCT00168844|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
167197|NCT00168844|Secondary|Change From Baseline in Lactic Dehydrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
167198|NCT00168844|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
167199|NCT00168844|Secondary|Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
167200|NCT00168844|Secondary|Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Units per litre (U/L)||Standard Deviation|Mean
167201|NCT00168844|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
167202|NCT00168844|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||millimoles per litre (mmol/L)||Standard Deviation|Mean
167203|NCT00168844|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167204|NCT00168844|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167205|NCT00168844|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167206|NCT00168844|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167207|NCT00168844|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167208|NCT00168844|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167209|NCT00168844|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167210|NCT00168844|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167211|NCT00168844|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167212|NCT00168844|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167222|NCT00168844|Secondary|Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
167223|NCT00168844|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
167224|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||bpm||Standard Deviation|Mean
167225|NCT00168844|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167226|NCT00168844|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167227|NCT00168844|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167228|NCT00168844|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167229|NCT00168844|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||milliseconds (msec)||Standard Deviation|Mean
167230|NCT00168844|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)||beats per minute (bpm)||Standard Deviation|Mean
167231|NCT00168844|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year.~For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.||Number of exacerbations per patient year||Standard Deviation|Mean
167232|NCT00168844|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9~For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
167233|NCT00168844|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
167234|NCT00168844|Primary|Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)|Trough Forced Expiratory Volume in 1 second (FEV1)|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167235|NCT00168831|Secondary|PGR Scores|Patient's Global rating (PGR) scores over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Patient's Global Rating (FAS-PGR)||Points on a scale||Standard Error|Mean
167236|NCT00168831|Secondary|PGE Scores|Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1−2 = Poor, 3−4 = Fair, 5−6 = Good, 7−8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.|Week 48|Full Analysis Set - Physician's Global Evaluation (FAS-PGE)||Points on a scale||Standard Error|Mean
167237|NCT00168831|Secondary|COPD Symptoms Scores|"COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period.~Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - COPD symptoms (FAS-SYM)||Points on a scale||Standard Error|Mean
167238|NCT00168831|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Scores|"Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0.~The means are adjusted for centre, smoking status at entry and baseline value."|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
167239|NCT00168831|Secondary|Mahler TDI Scores|"Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value.~Worst score = -3, best score = +3"|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
167240|NCT00168831|Secondary|Weekly Mean Number of Puffs of Rescue Medication Per Day|Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.|Weeks 2, 8, 16, 24, 32, 40, 48|Full Analysis Set - Diary (FAS-DRY)||Puffs||Standard Error|Mean
167243|NCT00168831|Secondary|Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167244|NCT00168831|Secondary|Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks|FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167245|NCT00168831|Secondary|Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks|Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167246|NCT00168831|Secondary|Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167247|NCT00168831|Secondary|Change From Baseline in Albumin|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||g/L||Standard Deviation|Mean
167248|NCT00168831|Secondary|Change From Baseline in Protein, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||grams per litre (g/L)||Standard Deviation|Mean
167249|NCT00168831|Secondary|Change From Baseline in Uric Acid|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
167250|NCT00168831|Secondary|Change From Baseline in Bilirubin, Total|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||umol/L||Standard Deviation|Mean
167251|NCT00168831|Secondary|Change From Baseline in Creatinine|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||micromoles per litre (umol/L)||Standard Deviation|Mean
167252|NCT00168831|Secondary|Change From Baseline in Blood Urea Nitrogen|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||milligrams per decilitre (mg/dL)||Standard Deviation|Mean
167253|NCT00168831|Secondary|Change From Baseline in Urea|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
167254|NCT00168831|Secondary|Change From Baseline in Glucose|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
167255|NCT00168831|Secondary|Change From Baseline in Lactic Dehyrogenase (LDH)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
167256|NCT00168831|Secondary|Change From Baseline in Alkaline Phosphatase|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
167257|NCT00168831|Secondary|Change From Baseline in Alanine Transaminase/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (SGPT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||U/L||Standard Deviation|Mean
167258|NCT00168831|Secondary|Change From Baseline in Aspartate Transaminase/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||Units per litre (U/L)||Standard Deviation|Mean
167259|NCT00168831|Secondary|Change From Baseline in Phosphate|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||mmol/L||Standard Deviation|Mean
167260|NCT00168831|Secondary|Change From Baseline in Calcium|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||millimoles per litre (mmol/L)||Standard Deviation|Mean
167261|NCT00168831|Secondary|Change From Baseline in Monocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167262|NCT00168831|Secondary|Change From Baseline in Lymphocytes (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167263|NCT00168831|Secondary|Change From Baseline in Basophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167264|NCT00168831|Secondary|Change From Baseline in Eosinophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167265|NCT00168831|Secondary|Change From Baseline in Neutrophils (Absolute)|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||10^9/L||Standard Deviation|Mean
167266|NCT00168831|Secondary|Change From Baseline in Monocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167267|NCT00168831|Secondary|Change From Baseline in Lymphocytes|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167268|NCT00168831|Secondary|Change From Baseline in Basophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167269|NCT00168831|Secondary|Change From Baseline in Eosinophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167270|NCT00168831|Secondary|Change From Baseline in Neutrophils|Week 48 - baseline|Baseline to Week 48 or at premature discontinuation if before Week 48|Safety Set||percentage of white blood cell count||Standard Deviation|Mean
167276|NCT00168831|Secondary|Change From Baseline in VPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
167277|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
167278|NCT00168831|Secondary|Change From Baseline in Ventricular Premature Beat (VPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
167279|NCT00168831|Secondary|Change From Baseline in SVPB Pairs|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||pairs per 24 hours||Standard Deviation|Mean
167280|NCT00168831|Secondary|Change From Baseline in SVPB Run Events|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||events per 24 hours||Standard Deviation|Mean
167281|NCT00168831|Secondary|Change From Baseline in Supraventricular Premature Beat (SVPB) Total|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||premature beats per 24 hours||Standard Deviation|Mean
167282|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 - baseline|Baseline to Week 40|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||bpm||Standard Deviation|Mean
167283|NCT00168831|Secondary|Change From Baseline in QT Interval (Fridericia)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167284|NCT00168831|Secondary|Change From Baseline in QT Interval (Bazett)|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167285|NCT00168831|Secondary|Change From Baseline in QT Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167286|NCT00168831|Secondary|Change From Baseline in QRS Interval|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead ECG and 24-hour Holter monitoring performed (see protocol and clinical trial report)||msec||Standard Deviation|Mean
167287|NCT00168831|Secondary|Change From Baseline in PR Interval||Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)||milliseconds (msec)||Standard Deviation|Mean
167288|NCT00168831|Secondary|Change From Baseline in Heart Rate|Week 40 pre-dose - baseline|Baseline to Week 40 pre-dose|Combined analysis of studies NCT00168844 and NCT00168831 in subset of patients who had additional 12-lead electrocardiogram (ECG) and 24-hour Holter monitoring performed (see protocol and clinical trial report)||beats per minute (bpm)||Standard Deviation|Mean
167289|NCT00168831|Primary|COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)|"Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year~For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined."|48 weeks|Safety Set. Combined analysis of studies NCT00168844 and NCT00168831. 670 patients analysed in total comprises 338 patients from NCT00168831 and 332 patients from study NCT00168844, 667 patients - 335 and 332, 653 patients - 334 and 319 respectively.||Number of exacerbations per patient year||Standard Deviation|Mean
167290|NCT00168831|Primary|TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)|"Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9~For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined."|Week 48|Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI)||Points on a scale||Standard Error|Mean
167291|NCT00168831|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)|Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0|Week 48|Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)||Points on a scale||Standard Error|Mean
167292|NCT00168831|Primary|Change From Baseline in Trough FEV1 After 48 Weeks|Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks|10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication|Full Analysis Set - Clinic Spirometry (FAS-PFT)||Litres||Standard Error|Mean
167293|NCT00168818|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients||participants|||Number
167294|NCT00168818|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|||mL||Standard Deviation|Mean
167295|NCT00168818|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1|||participants|||Number
167311|NCT00168805|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op||Participants|||Number
167296|NCT00168818|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 31-38 days|Treated set||Participants|||Number
167297|NCT00168818|Secondary|Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|end of treatment to day 91±7|Patients with any data available during follow-up||Participants|||Number
167298|NCT00168818|Secondary|Death During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
167299|NCT00168818|Secondary|Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
167300|NCT00168818|Secondary|Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
167301|NCT00168818|Secondary|Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
167302|NCT00168818|Secondary|Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
167303|NCT00168818|Secondary|Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 31-38 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)||Participants|||Number
167304|NCT00168818|Primary|Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 31-38 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)||Participants|||Number
167305|NCT00168805|Secondary|Laboratory Analyses|Frequency of patients with possible clinically significant abnormalities.|First administration to end of study|Treated patients||participants|||Number
167306|NCT00168805|Secondary|Volume of Blood Loss|Volume of blood loss for treated and operated patients during surgery.|Day 1|||mL||Standard Deviation|Mean
167307|NCT00168805|Secondary|Blood Transfusion|Blood transfusion for treated and operated patients on Day of surgery.|Day 1|||participants|||Number
167308|NCT00168805|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 6-10 days|Treated set||Participants|||Number
167309|NCT00168805|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up||Participants|||Number
167310|NCT00168805|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op||Participants|||Number
167312|NCT00168805|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
167313|NCT00168805|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
167314|NCT00168805|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
167315|NCT00168805|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 6-10 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)||Participants|||Number
167316|NCT00168805|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 6-10 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)||Participants|||Number
167317|NCT00168454|Post-Hoc|Percentage of Patients With 100% Reduction From Baseline of Urinary Urge Incontinence Episodes|Measured by the 7 day diary preceding each visit. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36|Intent to Treat||Percentage of patients|||Number
167318|NCT00168454|Secondary|Incontinence Quality of Life Instrument (I-QOL)|Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.|Baseline, Week 2, Week 6, Week 12|Intent to Treat||Units on a scale|||Number
167319|NCT00168454|Secondary|Maximum Cystometric Capacity (MCC) by Urodynamic Measurements|Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters|Baseline, Week 12|Intent to Treat||milliliters|||Number
167320|NCT00168454|Secondary|Change in Number of Nocturia Episodes|Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.|Baseline, Week 12|Intent to Treat||episodes|||Number
167321|NCT00168454|Secondary|Change in Number of Micturitions|Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.|Baseline, Week 2, Week 6, Week 12|Intent to Treat||micturitions|||Number
167322|NCT00168454|Primary|Change in Number of Urinary Urge Incontinence Episodes|Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.|Baseline, Week 2, Week 6, Week 12|Intent to Treat||episodes|||Number
167323|NCT00168428|Secondary|Percentage of Patients With Severe HIT-6 Impact Category Scores|Percentage of patients with a severe (60-78) score on the Headache Impact Test (HIT-6) Questionnaire during the 28 day period, ending with Week 24. The HIT-6 consisted of 6 questions about headache and impact on the patient's health and well-being. Answers for each question ranged from 6=Never, 8=Rarely, 10=Sometimes, 11=Very Often, and 13=Always. The total scores ranged from 36-49 (Little or No Impact), 50-55 (Some Impact), 56-59 (Substantial Impact) and 60-78 (Severe Impact).|Week 24|Intent to Treat||Percentage of Patients|||Number
167324|NCT00168428|Secondary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat||Headache Episodes||Standard Deviation|Mean
167325|NCT00168428|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting the ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
167326|NCT00168428|Secondary|Change in Frequency of Moderate/Severe Headache Days|Mean change from baseline in frequency (number) of moderate/severe headache days during the 28 day period ending with Week 24. Those calendar days with >= 4 continuous hours of headache were selected. As per the patient diary, all headache episodes occurring during those days with a maximum severity of moderate or severe were counted.|Baseline, Week 24|Intent to Treat||Moderate/Severe Headache Days||Standard Deviation|Mean
167327|NCT00168428|Secondary|Change in Total Cumulative Hours of Headache Occurring on Headache Days|Mean change from baseline in total cumulative hours of headache occurring on headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] when the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat||Hours||Standard Deviation|Mean
167328|NCT00168428|Primary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache.|Baseline, Week 24|Intent to Treat||Headache Days||Standard Deviation|Mean
167329|NCT00168389|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
167330|NCT00168389|Secondary|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients||Days|||Number
167331|NCT00168389|Secondary|Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. The average OCT retinal thickness is calculated across study visits for each patient. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients with data at the time point||Microns||Standard Deviation|Mean
167332|NCT00168389|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
167333|NCT00168389|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
167334|NCT00168389|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
167335|NCT00168389|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
167336|NCT00166296|Secondary|Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.|"The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale.~We present data of de depression subscale. The seven-item Depression subscale yields a score of 0–21, with higher scores meaning higher levels of depressive symptoms."|12 weeks after interferon treatment onset|||Scores on a Scale||Standard Error|Mean
167337|NCT00166296|Secondary|Total Score in the Montgomery-Asberg Depression Rating Scale|"The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires.~Items are rated on a scale of 0–6. Scores range from 0 to 60, higher scores meaning higher levels of depression."|12 weeks after interferon treatment onset|||Scores on a scale||Standard Error|Mean
167338|NCT00166296|Primary|Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).|"Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response).~Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction."|Six months after the end of interferon treatment|Patients with available data for viral response 6 months after completion of interferon treatment were compared between treatment groups.||Participants|||Number
167339|NCT00166296|Primary|Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.|"At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death.~At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation."|First three months of interferon treatment.|One of 67 patients allocated to the escitalopram group and 3 of 66 in placebo did not receive the first dose of study medications. Consequently, 66 patients treated with escitalopram and 63 with placebo were included in the intention to treat analysis, with a procedure of last observation carried forward (LOCF).||Participants|||Number
167343|NCT00166205|Primary|Percent Excess Weight Loss|Percent Excess Weight Loss (%EWL) with the SAGB at three years post operatively minus baseline.|3 Years Post Operative|Intent to Treat (ITT), Last Observation Carried Forward (LOCF)||Percent Excess Weight Loss||95% Confidence Interval|Mean
167344|NCT00166205|Secondary|Number of All Adverse Events of Subjects Implanted With the SAGB|The evaluation of all Adverse Events of subjects implanted with the Swedish Adjustable Gastric Band throughout the three-year post-operative period (related to device and unrelated to device).|3 Years|||Total Number of Adverse Events|||Number
167345|NCT00166205|Secondary|Changes in Glycosylated Hemoglobin (HbA1c)|Changes in glycosylated hemoglobin (HbA1c), from baseline to three-years post-operative.|3 years|||Percent of total hemogloobin||Standard Deviation|Mean
167346|NCT00166205|Secondary|Changes in Quality of Life (QOL) Measures|Changes in QOL measures at three-years post-operative minus baseline. SF-36 scores from 0-100 with higher scores representing better QOL.|3 years|||Units on a scale||Standard Deviation|Mean
167347|NCT00166205|Secondary|Change in Absolute Weight|Absolute weight loss as measured on a standardized Tanita Scale (used at all sites) at three-years post-operative minus baseline.|3 years|||Pounds||Standard Deviation|Mean
167348|NCT00166205|Secondary|Changes in Body Mass Index (BMI)|Changes in Body Mass Index (BMI) at three-years post-operative minus baseline.|3 years|||kg/m2||Standard Deviation|Mean
167349|NCT00166205|Secondary|Changes in Excess Body Weight (EBW)|Changes in excess body weight at 3-years post-operative minus baseline excess weight. Excess weight is computed as baseline weight minus Ideal weight. Ideal weight as provided in the 1983 Metropolitan Life Height and Weight Table using the upper limit of the midpoint range.|3 years|||Pounds||Standard Deviation|Mean
167350|NCT00166205|Primary|Percent of Subjects Who Had Adverse Events With the Swedish Adjustable Gastric Band (SAGB)|Percent of device-related adverse events (AEs) and device malfunctions occurring in subjects implanted with the Swedish Adjustable Gastric Band from baseline throughout the three-year post-operative period.|3 years|Intent to Treat (ITT)||Percent of Subjects|||Number
167351|NCT00168337|Post-Hoc|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
167352|NCT00168337|Post-Hoc|10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.|Baseline, 39 Months|Intent to Treat: all randomized patients||Days|||Number
167353|NCT00168337|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Microns||Standard Deviation|Mean
167354|NCT00168337|Secondary|Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
167355|NCT00168337|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
167356|NCT00168337|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 39 Months|Intent to Treat: all randomized patients||Letters||Standard Deviation|Mean
167357|NCT00168337|Primary|Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 39/Final Visit|Intent to Treat: all randomized patients||Percentage of Patients|||Number
167358|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
167359|NCT00168324|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
167360|NCT00168324|Primary|Cumulative Response Rate of 15 or More Letter Improvement|The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.|Up to 180 Days|Intent-to-Treat: all randomized patients||Kaplan-Meier Estimate|||Number
167361|NCT00168324|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients||Microns (µm)||Standard Deviation|Mean
167362|NCT00168324|Secondary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.|Day 90, Day 180|Intent-to-Treat: all randomized patients||Number of Participants|||Number
167363|NCT00168311|Primary|Scale for the Asessment of Negative Symptoms (SANS)|Scale for Assessment of Negative Symptoms [SANS]. This is a semi structured interview. Assessments are conducted on a six-point scale (0=not at all to 5=severe)with a total score range of 0-70. A score of >50 is considered to be a moderate-severe intensity.|3 weeks|||Scores on a scale||Standard Deviation|Mean
167364|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 180|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
167365|NCT00168298|Secondary|Percentage of Patients With a Change From Baseline in BCVA by Category|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.|Baseline, Day 90|Intent-to-Treat: all randomized patients||Percentage of Patients|||Number
167366|NCT00168298|Secondary|Change From Baseline in Retinal Thickness in the Study Eye|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Day 90, Day 180|Intent-to-Treat: all randomized patients||Microns (µm)||Standard Deviation|Mean
167367|NCT00168298|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Day 180|Intent-to-Treat: all randomized patients||Number of Participants|||Number
167368|NCT00168103|Secondary|Number of Vomiting Episodes||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Episodes per subject||Full Range|Median
167369|NCT00168103|Other Pre-specified|Number of Subjects Receiving Rescue Study Medication||Within 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Subjects|||Number
167370|NCT00168103|Other Pre-specified|Time to Complete Resolution of All HAE Symptoms, Including Pain|Complete resolution of symptoms was determined by subject self-assessment.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Hours||Full Range|Median
167371|NCT00168103|Secondary|Number of Subjects With Worsened Intensity of Clinical HAE Symptoms|Includes any worsening of intensity of at least 1 of the HAE symptoms present at baseline. Routinely checked symptoms included pain, nausea, vomiting, cramps, and diarrhea.|Baseline and between 2 and 4 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Subjects|||Number
167372|NCT00168103|Primary|Time to Start of Relief of Symptoms From HAE Attack|The start of symptom relief was determined by subject self-assessment. Time to start of symptom relief was set to 24 hours if the subject received rescue medication (blinded study medication, narcotic analgesics, antiemetics, open-label C1-INH, or fresh frozen plasma) at any time point after the start of study treatment but before start of relief.|Up to 24 h after start of study treatment|Analysis was based on the ITT population which included all subjects receiving any portion of the randomized study medication.||Hours||Full Range|Median
175892|NCT00069823|Secondary|Pulmonary Function: Change in PC20|Mean Change in the dose of methacholine that results in a 20% drop in FEV1|Baseline to 24 Weeks|||mg/ml||95% Confidence Interval|Mean
167373|NCT00168064|Secondary|Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)|Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart.|Baseline to end of therapy|||Percent of participants|||Number
167374|NCT00168064|Secondary|Severity-weighted Assessment Tool (SWAT) Within up to 12 Months by 2 or More Consecutive Observations Over at Least 4 Weeks||Assessment made at Day 1 and every subsequent visit during treatment||||||
167375|NCT00168064|Primary|Ratio of Response Rates Based on CAILS|The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment|Assessment made at Day 1 and every subsequent visit during treatment|ITT||percentage of participants|||Number
167376|NCT00168038|Secondary|Maximum Platelet Level|Maximum absolute platelet count achieved over the duration of the study.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.||10^9/L||Full Range|Median
167377|NCT00168038|Secondary|Duration of Platelet Response|The number of days the platelet count remained ≥ 50 x 10^9/L.|up to 29 days|Analyzed for responders in the ITT population, i.e., only subjects with at least one platelet measurement ≥ 50 x 10^9/L after start of treatment||days|Participants|Inter-Quartile Range|Median
167378|NCT00168038|Secondary|Time to Platelet Response|Median time to reach a platelet count ≥ 50 x 10^9/L.|29 days|ITT analysis. The ITT population comprised all subjects who received at least once study medication.||days||Inter-Quartile Range|Median
167379|NCT00168038|Secondary|Regression of Hemorrhage (Internal)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with internal bleeding at baseline and respective post-baseline assessment.||participants|||Number
167380|NCT00168038|Secondary|Regression of Hemorrhage (Nose)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with nose bleeding at baseline and respective post-baseline assessment.||participants|||Number
167381|NCT00168038|Secondary|Regression of Hemorrhage (Genitourinary Tract)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with genitourinary tract bleeding at baseline and respective post-baseline assessment.||participants|||Number
167382|NCT00168038|Secondary|Regression of Hemorrhage (Oral Cavity)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|29 days|The number of participants analyzed represents the number of subjects in the ITT population with oral cavity bleeding at baseline and respective post-baseline assessment.||participants|||Number
167383|NCT00168038|Secondary|Regression of Hemorrhage (Skin)|Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.|up to 29 days|The number of participants analyzed represents the number of subjects in the ITT population with skin bleeding at baseline and respective post-baseline assessment.||participants|||Number
167384|NCT00168038|Primary|Platelet Response|The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.|7 days|Intention to treat (ITT) analysis. The ITT population comprised all subjects who received at least once study medication.||Percent of participants||95% Confidence Interval|Number
167385|NCT00167778|Secondary|How Bothersome Was Your Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
167386|NCT00167778|Secondary|Pain Interference With Activities?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
167387|NCT00167778|Secondary|Least Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
167388|NCT00167778|Secondary|Worst Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
167389|NCT00167778|Secondary|Average Residual Limb Pain?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks.|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
167390|NCT00167778|Secondary|Residual Limb Pain at Present?|The residual limb pain grade scores ranged from 0 “No Pain/ Interference” to 10 “Severe Pain/Interference.”|Measurements were taken after wearing the study prostheses for four weeks|10 participants wore both study prostheses but only 7 participants presented with pain.||units on a scale||Standard Error|Mean
167391|NCT00167778|Secondary|Six-minute Walk Distance|Participants are asked to walk alone as far as possible without running for six minutes. This test is performed indoors along a long, flat straight hallway of approximately 30 meters in length with two orange cones marking the 180 degree turnaround points at each end of the corridor. Approximately 40 straight steps were taken for every four turning steps.|Six minutes after wearing the study prostheses for four weeks.|Each participant wore both study prostheses.||m||Standard Error|Mean
167392|NCT00167778|Secondary|Activity Level|Average number of steps per day over a 1 week period ending in the fourth week of each study prosthesis (Rigid and Torsion adapter)|One week|Each participant wore both study prostheses.||Steps/day||Standard Error|Mean
167393|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
167394|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
167395|NCT00167778|Secondary|Peak External Rotation Moment of the Inside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
167396|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Ankle While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
167397|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Knee While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
167398|NCT00167778|Secondary|Peak External Rotation Moment of the Outside Hip While Turning||Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||N*mm/kg||Standard Deviation|Mean
167399|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167400|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167401|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167402|NCT00167778|Primary|Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167403|NCT00167778|Primary|Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167433|NCT00167206|Secondary|Immune Reconstitution - Mean Value (2 Years)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 2 years post-transplant.|at 2 years after transplant|||Number of CD4 cells per microliter||Standard Deviation|Mean
167404|NCT00167778|Primary|Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167405|NCT00167778|Primary|Local Dynamic Stability (Ankle During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167406|NCT00167778|Primary|Local Dynamic Stability (Knee During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167407|NCT00167778|Primary|Local Dynamic Stability (Hip During Straight Walking)|Maximum finite-time Lyapunov exponents were used to estimate the local dynamic stability of the amputee’s sagittal plane hip, knee and ankle angles for their prosthetic limb with and without the torsion adapter while walking straight, while turning with the prosthesis on the inside of the turn, and while turning with the prosthesis on the outside of the turn. Maximum finite-time Lyapunov exponents measure the rate of kinematic separation of a gait cycle trajectory perturbed by naturally occurring disturbances and neuromuscular control errors. A positive exponent indicates divergence of a system, with increasing values indicating a les stable system.|Measurements were taken after wearing the study prostheses for three weeks.|Each participant wore both study prostheses.||dimensionless||Standard Deviation|Mean
167408|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole, Tetraethylammonium (TEA), and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|60 minutes, 90 minutes|Only 10 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
167409|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Fluconazole and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after fluconazole and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 11 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
167410|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release After Tetraethylammonium (TEA) and Bradykinin Administration|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA after Tetraethylammonium (TEA) and t-PA after bradykinin 400 ng/min|30 minutes, 60 minutes|Only 18 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
167411|NCT00166166|Secondary|Change in Tissue Plasminogen Activator (t-PA) Release|Individual net t-PA release at each time point were calculated by the following formula: net release = (Cv-CA) x {FBF x [101-hematocrit/100]}, where Cv and CA represent the concentration of t-PA in the brachial vein and artery, respectively. Change is the difference of t-PA at baseline and t-PA after bradykinin 400 ng/min|Baseline, 30 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.||ng/mL||Standard Error|Mean
167412|NCT00166166|Secondary|Forearm Blood Flow (FBF) After Sodium Nitroprusside Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of sodium nitroprusside. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed.|5 minutes|Only 80 of the original 174 subjects were treated for this portion of the study.||mL min^-1 * 100 mL^-1||Standard Error|Mean
167413|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole and Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of fluconazole and Tetraethylammonium (TEA) administration. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from FBF after fluconazole administration and after Tetraethylammonium (TEA) administration.|5 minutes, 10 minutes|Only 19 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
167434|NCT00167206|Secondary|Immune Reconstitution - Mean Value (1 Year)|Calculated mean value of patient CD4 values collected at intervals from Day 30 through 1 year post-transplant.|1 year post-transplant.|||Number of CD4 cells per microliter||Standard Deviation|Mean
167414|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After L-NG-monomethyl Arginine (L-NMMA) and Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after L-NMMA administration and administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF after L-NMMA administration and then fluconazole administration.|5 minutes, 10 minutes|Only 15 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
167415|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Fluconazole Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of fluconazole. Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after fluconazole administration.|Baseline, 5 minutes|Only 33 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
167416|NCT00166166|Secondary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA) and Tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from after L-NMMA administration and after TEA administration.|5 minutes, 10 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
167417|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Administration of L-NG-monomethyl Arginine (L-NMMA)|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph after administration of L-NG-monomethyl Arginine (L-NMMA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference in FBF from baseline and after L-NMMA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
167418|NCT00166166|Primary|Percent Change in Forearm Blood Flow (FBF) After Tetraethylammonium (TEA) Administration|Simultaneous forearm blood flow (FBF) measurements were obtained in both arms using a dual-channel venous occlusion strain gauge plethysmograph at rest and after administration of tetraethylammonium (TEA). Flow measurements were recorded for approximately 7 seconds, every 15 seconds up to eight times and a mean FBF value was computed. Percent change is the difference from baseline FBF and after TEA administration.|Baseline, 5 minutes|Only 62 of the original 174 subjects were treated for this portion of the study.||percent change||Standard Error|Mean
167419|NCT00166114|Primary|Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8|"Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.~The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder = < 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score"|Baseline, Week 8|||participants|||Number
167420|NCT00167544|Secondary|Survival Without Severe Bronchopulmonary Dysplasia (BPD)|Using the NIH Consensus definition (Jobe A, 2001)|36 weeks postmenstrual age|||participants|||Number
167421|NCT00167544|Secondary|Duration of Oxygen Requirement||Up to 36 weeks PMA|||days||95% Confidence Interval|Mean
167422|NCT00167544|Secondary|Duration of Positive Pressure Support (Mechanical Ventilation or Continuous Positive Airway Pressure)||Up to 36 weeks PMA|||days||95% Confidence Interval|Mean
167423|NCT00167544|Secondary|Regional Brain Volumes|Cerebral white matter volume|38-weeks postmenstrual age|In addition to the reasons cited for the primary outcome, one infant in the hydrocortisone group and two in the placebo group had artifacts on brain MRI precluding cerebral white matter segmentation and volume determination.||cm^3||Standard Deviation|Mean
167424|NCT00167544|Primary|Total Cerebral Volume as Measured by Volumetric Brain MRI|Total cerebral volume included all brain gray matter and white matter, including cerebellum.|38 weeks postmenstrual age (PMA)|Eight infants died in each group prior to term MRI precluding a determination of brain volumes. Additionally, four infants had poor quality MRI scans that could not be analyzed for brain volumes.||cm^3||Standard Deviation|Mean
167425|NCT00167245|Secondary|The Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale During the Medication Treatment Phase, Compared to Placebo-treated Subjects.||13 weeks||||||
167426|NCT00167245|Secondary|Days Abstinent From Drinking, Frequency of Heavy Drinking Days, and Cocaine Use (Confirmed by Urine Drug Screen) as Measured by the Time Line Follow-Back During the Treatment Phase, Compared to Less Topiramate-adherent (<80% Pills Taken).||13 weeks||||||
167427|NCT00167245|Secondary|Fewer Days of Cocaine Use as Measured by the Time Line Follow Back in the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks||||||
167428|NCT00167245|Secondary|Days Abstinent From Drinking and Frequency of Heavy Drinking Days as Measured by the Time Line Follow-Back During the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.||12 weeks||||||
167429|NCT00167245|Primary|Number of Heavy Drinking Days|Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women|13 weeks|||number of heavy drinking days||Standard Error|Mean
167430|NCT00167245|Primary|Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial|Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.|Last 3 weeks of 13 week trial|||Percent of participants|||Number
167431|NCT00167206|Secondary|Number of Patients Alive at 2 Years|Calculated from Day 1 of hematopoietic cell transplant to 2 years post-transplant.|2 years after transplant|||Participants|||Number
167435|NCT00167206|Secondary|Number of Patients Who Exhibited Regimen-related Toxicity (RRT)|Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. Regimen-related toxicity involves harmful effects in an organism through exposure to the treatment given.|1 year after hematopoietic cell transplant|||Participants|||Number
167436|NCT00167206|Secondary|Number of Patients With Chronic Graft Versus-Host Disease (GVHD)|"Calculated from Day 1 of hematopoietic cell transplant to 1 year after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|1 year after hematopoietic cell transplant|||Participants|||Number
167437|NCT00167206|Secondary|Number of Patients With Acute Graft Versus-Host Disease (aGVHD)|"Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. GVHD is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack."|Day 100 after hematopoietic cell transplant|||Participants|||Number
167438|NCT00167206|Secondary|Number of Patients Who Exhibited Secondary Graft Failure|Calculated from Day 1 of hematopoietic cell transplant to Day 100 after transplant. A complication after Bone Marrow Transplant in which the transplanted stem cells do not grow in the recipient’s bone marrow and thus do not produce new blood cells.|Day 100 after hematopoietic cell transplant|||Participants|||Number
167439|NCT00167206|Primary|Number of Patients Who Exhibited Hematopoietic Recovery and Engraftment|Calculated from Day 1 of hematopoietic cell transplant to Day 42 post-transplant. Hematopoietic recovery and engraftment is defined as the first of three consecutive days the patient's absolute neutrophil count is greater than or equal to 0.5X10^9/Liter.|Day 42 after hematopoietic cell transplant|||Participants|||Number
167440|NCT00167102|Primary|Number of Adverse Events|Number of any adverse event reported throughout the study, regardless of relation to study drug|24 weeks|||adverse events|||Number
167441|NCT00167102|Secondary|To Qualitatively Assess the Subjects Perception of Their Scalp Disease With Treatment, and Upon Withdrawal of Treatment, in Relation to Baseline.||12 weeks||||||
167442|NCT00167102|Secondary|In Those Who Respond to Treatment, the Durability of the Response Will be Assessed Over a 12-week Post-treatment Period of Observation.||12 weeks||||||
167443|NCT00167102|Primary|The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values|Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept in subjects with chronic severe scalp alopecia|12 weeks|||percentage of participants|||Number
167444|NCT00166036|Secondary|Change in Flow-mediated Dilatation (FMD)|Flow-mediated dilatation (FMD) of the brachial artery was used to asses Endothelial Function. The endothelium, by releasing nitric oxide (NO), promotes vasodilation and inhibits inflammation, thrombosis, and vascular smooth muscle cell proliferation.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline & 12 Weeks|||Percentage of brachial artery diameter||Standard Error|Mean
167445|NCT00166036|Primary|Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels|Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.|Baseline &12 Weeks|||nmol/mL||Standard Error|Mean
167446|NCT00165984|Primary|Survival|Follow-up study designed to determine the impact of genetic factors on survival in single ventricle patients|7 yr mean follow-up|All patients enrolled were genotyped||percentage of patients alive/nontrans|||Number
167447|NCT00165984|Primary|To Evaluate the Incidence of the Pre-proendothelin SNP at Nucleotide 5665||7 years|165 enrolled patients were analyzed for this polymorphism||participants|||Number
167448|NCT00165958|Primary|Number of Participants With Cyst Recurrence|Recurrence of cyst after removal|16 months|||participants|||Number
167449|NCT00165841|Secondary|The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month|6-month maintenance phase||||||
167450|NCT00165841|Secondary|The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase|The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase|6-month maintenance phase||||||
167451|NCT00165841|Primary|The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).|The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.|6 months double-blind maintenance phase|Intent-to-treat (ITT) population, total 187 subjects, was used for efficacy analyses. Safety population (total 200 subjects) was used for safety analysis and participant flow.||Percentage of Days||Standard Deviation|Mean
167452|NCT00166712|Secondary|Patient and Graft Survival Rates at 6 and 12 Months Post-transplant||At 6 & 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.|||||
167453|NCT00166712|Secondary|Incidence of Donor Specific Hyporesponsiveness Allowing for the Conversion to Monotherapy|The proportion of subjects for both groups determine this measure: 1) Patients in tacrolimus arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesonsiveness at 9 months post-transplant (those staying on TAC+MMF) or 3 months post-convertion (converted from TAC+MMF to Sirolimus+MMF) will be weaned to MMF monotherapy; 2) Those in the sirolimus+MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.|At 6 & 9 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.|||||
167454|NCT00166712|Secondary|Renal Function at 12 Months Post-transplant|Laboratory tests for renal function include creatinine or iothalamate glomerular filtration rate (GFR).|At 12 months post-transplant|Study was stopped due to efficacy and no data was collected for this outcome measure.|||||
167455|NCT00166712|Secondary|Severity of Acute Rejection During the First 6 and 12 Months Post-transplant|The diagnosis of rejection will be based on clinical symptoms and signs, laboratory tests, and confirmed by core renal allograft biopsy.|Months 6-12 post-transplant|Study was terminated due to efficacy and there is no data was collected for this outcome measure.|||||
167456|NCT00166712|Primary|The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant.|The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant.|Within 12 months post kidney transplant|33 total subjects reached the 12 month participation mark.||Participants|||Number
167457|NCT00166517|Secondary|Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in~SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population||Participants|||Number
167458|NCT00166517|Primary|Serum Anti-Rotavirus IgA Response|"Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in~Serum IgA 14 days Postdose 3"|Baseline and 14 days Postdose 3|Per Protocol Population||Participants|||Number
167459|NCT00166504|Primary|LDL-C Lowering Efficacy|LDL-C = low density lipoprotein cholesterol, measured in mg/dl.|6 weeks|Included patients with LDL-C data at both baseline and at the 6-week post-randomization time point.||Percent Change from Baseline||Standard Deviation|Least Squares Mean
167460|NCT00166361|Primary|Mean Stent Dwell Time|Stent dwell time is defined as the amount of time a stent can remain in the body after it placed, before it needs to be removed due to failure.|baseline to 59 months after placement of stent|||months||Full Range|Mean
167461|NCT00165789|Primary|Number of Participants With Any TEAE|Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section.|Through end of study|Safety Population was the primary population for analysis defined as all subjects who completed the Baseline Phase and who received at least 1 dose of double-blind study medication.||Participants|||Number
167462|NCT00165789|Secondary|Duration of Dyskinesia From UPDRS at Baseline and Day 70|The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population||Participants|||Number
167463|NCT00165789|Secondary|Disability of Dyskinesia From UPDRS at Baseline and Day 70|The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning.|Baseline and Day 70|Safety Population||Participants|||Number
167464|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Percentage of the Day||Standard Deviation|Mean
167465|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent on Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Percentage of the Day||Standard Deviation|Mean
167466|NCT00165789|Secondary|"Change From Baseline to Day 70 in Percent Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Percentage of the Day||Standard Deviation|Mean
167467|NCT00165789|Secondary|Change From Baseline to Day 70 in Goetz/Rush Score|The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks.|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Scores on a Scale||Standard Deviation|Mean
167480|NCT00165698|Secondary|New Fracture and Fall||12 months|Per Protocol Set (PPS)||participants|||Number
167468|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Hours||Standard Deviation|Mean
167469|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute on Time With Non-troublesome Dyskinesias"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Hours||Standard Deviation|Mean
167470|NCT00165789|Secondary|"Change From Baseline to Day 70 in Absolute Off Time"|"Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the on state experiencing troubling dyskinesias or off state. The on state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the off state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the on state and which interfered with activities or caused discomfort to any extent."|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Hour||Standard Deviation|Mean
167471|NCT00165789|Secondary|"Change From Baseline to Day 70 in on State of UPDRS Scores"|The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the “on” and “off” state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the “on” fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease).|Baseline and Day 70|Safety Population. Change from Baseline only reflect participants who completed the assessment at Baseline and Day 70.||Scores on a Scale||Standard Deviation|Mean
167472|NCT00165776|Secondary|Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment|Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline, Week 4|FAS||Millimeters||Standard Error|Mean
167473|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment|TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS||Points on a Scale||Standard Error|Mean
167474|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment|TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS||Points on a Scale||Standard Error|Mean
167475|NCT00165776|Secondary|Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment|TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.|Baseline, Week 4|FAS||Points on a Scale||Standard Error|Mean
167476|NCT00165776|Primary|Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment|"The TWSTRS-Total score is the sum of scores of the three components of the scale:~TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity)~TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain)~TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability).~The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score."|Baseline, Week 4|Full Analysis Set (FAS) population: All subjects who received study treatment||Points on a Scale||Standard Error|Mean
167477|NCT00165776|Secondary|Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment|Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Week 4|FAS||Millimeters||Standard Error|Mean
167478|NCT00165776|Secondary|Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment|"Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: Considering all the ways your cervical dystonia affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 4|FAS||Millimeters||Standard Error|Mean
167479|NCT00165698|Secondary|Height (Meter)||Baseline and 12 months|Per Protocol Set (PPS)||meters||Standard Deviation|Mean
167489|NCT00165672|Primary|The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).|Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring.|Baseline and 4 weeks|The major endpoint of this study was analysed in the population for clinical pharmacology data (observation period and treatment period)||Percent Time||Standard Deviation|Mean
167490|NCT00165646|Primary|Percentage of Participants With Complete Relief of Heartburn at Final Evaluation|“Heartburn diary” will be given to each subject and ask him/her to keep the diary every day throughout the study period. The subject will be requested to record the occurrence of heartburn during the daytime and the nighttime in the diary. Primary End Point is the rate of complete disappearance of heartburn. The rate of heartburn do not occur in the past week will be calculated based on the diary. Participants were evaluated at week 4 about episodes of heartburn in the last 7 days|4 weeks|The major endpoint of this study was between-group comparison of the complete relief of heartburn (at the completion of the treatment period) in the full analysis set (FAS).||Percentage of participants|||Number
167491|NCT00165503|Primary|Adjuvant Chemotherapy Completion Rate|Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.|Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.|None of the enrolled participants were evaluated for the primary endpoint since none received the experimental adjuvant chemotherapy per protocol.|||||
167492|NCT00163293|Primary|Exacerbations (Post-hoc Analysis of Annual Rates)|A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age [yrs] and race were identified to be important beside treatment. The parameters centre and age [yrs] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution.|12 months|||number of events per year||Standard Error|Least Squares Mean
167493|NCT00163293|Secondary|Laboratory Work-up.||12 months||||||
167494|NCT00163293|Secondary|Physical Examination and Vital Signs||12 months||||||
167495|NCT00163293|Secondary|Quality of Life Assessments as Per Pediatric Asthma Quality of Life Questionnaires PAQLQ(S) and PACQLQ||12 months||||||
167496|NCT00163293|Secondary|Number of Symptom Free Days by Diary Entries||12 months||||||
167497|NCT00163293|Secondary|Number of Rescue Medication Free Days by Diary Entries|The number of rescue medication free days is the number of days during which the total puffs of rescue medication (salbutamol) use is 0. Assessment during baseline period at visit B2, B3 and B4 and during treatment period at visit T1, T2, T4, T6, T8, T10 and T12/Tend.|12 months||||||
167498|NCT00163293|Secondary|Rescue Medication Use by Diary Entries||12 months||||||
167499|NCT00163293|Secondary|Percent Nights With Nocturnal Awakenings Due to Asthma Symptoms||12 months||||||
167500|NCT00163293|Secondary|Total Symptom Score by Diary Entries||12 months||||||
167501|NCT00163293|Secondary|Diurnal PEF Fluctuation||12 months||||||
167502|NCT00163293|Secondary|Variation in PEF by Diary Entries||12 months||||||
167503|NCT00163293|Secondary|Morning and Evening PEF Measurements by Diary Entries||12 months||||||
167504|NCT00163293|Secondary|Change in FEV1 as Percent Predicted and Absolute Values||12 months||||||
167505|NCT00163293|Secondary|Drop-out Rate Due to Asthma Exacerbation||12 months||||||
167506|NCT00163293|Secondary|Number of Exacerbations||12 months||||||
167507|NCT00163293|Secondary|Duration of Exacerbations||12 months||||||
167508|NCT00163293|Secondary|Mean Rate of Asthma Exacerbations Per Year||12 months||||||
167509|NCT00163293|Secondary|Growth Velocity as Assessed by Stadiometric Height Measurement|Standing height measured in millimeters with a wall-mounted stadiometer|12 months|||mm/year||Standard Deviation|Mean
167510|NCT00163293|Primary|Time to First Exacerbation|Basis was the Intention to Treat Population (ITT). Time to first exacerbation is defined as the time until the first asthma exacerbation, or to end of T12 visit (=last visit).|12 months|Basis is the Intention to Treat (ITT) population. The ITT-analysis is based on those patients of the full analysis set having at least one post-baseline measurement of the primary efficacy outcome.||days||Standard Error|Mean
167511|NCT00163657|Primary|Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure|Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence|12 month post transplant|||participants|||Number
167512|NCT00163657|Primary|Freedom From Acute Rejection or HCV Recurrence or Treatment Failure|"Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"|12 months|||participants|||Number
167513|NCT00163215|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray – Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies those participants evaluated at that time point.||ratio||Standard Deviation|Mean
167514|NCT00163215|Secondary|Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||years||Standard Deviation|Mean
167515|NCT00163215|Secondary|Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||kg/m^2||Standard Deviation|Mean
167516|NCT00163215|Secondary|Body Mass Index (BMI)|BMI was used to measure body fat based on height and weight. It was calculated as body weight (kilogram) divided by the height (meter) squared.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
167517|NCT00163215|Secondary|Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25). GR in SDS was calculated using Sempe reference means and SD for growth. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
167518|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Standard Deviation|Mean
167519|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population|Change in AGR SDS for CA derived by subtracting AGR SDS CA at baseline from Yx value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 12, Month 24|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure.||SDS||Standard Deviation|Mean
167520|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36|Change in height SDS BA was derived by subtracting height SDS BA at baseline from Yx value. Height SDS BA (for both baseline and Yx) = (height–reference mean for BA)/reference SD for BA. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
167521|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
167522|NCT00163215|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36|Change in height SDS CA was derived by subtracting height SDS CA at baseline from Yx value. Height SDS CA (for both baseline and Yx) = (height – reference mean for CA)/reference SD for CA. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement – Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
167534|NCT00163189|Other Pre-specified|Number of Participants With Significant Changes in Physical Examinations|Number of participants with clinically significant physical examinations changes since previous visit were reported. Physical examination including estimation of pubertal stage and blood pressure measurement;|Baseline, Month 12, 24, 36, 48, 60, End of Treatment (EOT)|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
167626|NCT00162266|Primary|Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
167523|NCT00163215|Secondary|Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12. SDS indicates how similar the participant was to the reference population.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here “n” signifies those participants evaluated at that time point.||SDS||Standard Deviation|Mean
167524|NCT00163215|Secondary|Change From Baseline in Height at Month 12, Month 24 and Month 36|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||cm||Standard Deviation|Mean
167525|NCT00163215|Secondary|Height|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, Month 24, Month 36|"ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here n signifies those participants evaluated at that time point."||cm||Standard Deviation|Mean
167526|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|PP analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||cm/year||Standard Deviation|Mean
167527|NCT00163215|Secondary|Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population|Change in AGR at Yx was derived by subtracting AGR at baseline from Yx value. Annual growth rate was calculated each year and rescaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25).|Baseline, Month 12, Month 24, Month 36|ITT set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||centimeter per year (cm/year)||Standard Deviation|Mean
167528|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Per Protocol (PP) analysis set included all participants in the ITT set without a major protocol violation. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
167529|NCT00163215|Primary|Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population|Change in annual growth rate (AGR) standard deviation score (SDS) for chronological age (CA) derived by subtracting AGR SDS CA at baseline from each time point (Yx) value. AGR at Yx= (height Yx–height Y[x-1])/([date of Yx–date of Y{x-1}]/365.25). AGR as SDS calculated using Sempe reference means and standard deviations (SD) for growth rate. AGR SDS CA (for both baseline and Yx)= (AGR-reference mean for growth rate CA)/reference SD for growth rate CA. CA calculated as integer (Date of height measurement-Date of birth)/365.25*12. SDS indicates how similar participant was to reference population.|Baseline, Month 36|Intent to Treat (ITT) set included all participants who received at least 1 dose of study medication and had at least 1 evaluation of height after start of study medication. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and “n” signifies participants evaluated at that time point.||SDS||Standard Deviation|Mean
167530|NCT00163189|Other Pre-specified|Fasting and Postprandial Plasma Glucose Levels at Month 12, 24, 36, 48 and 60|Fasting and 2 hours plasma glucose levels were assessed using standard oral glucose tolerance test (OGTT).|Screening, Month 12, 24, 36, 48, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||milli mole per liter (mmol/L)||Standard Deviation|Mean
167531|NCT00163189|Other Pre-specified|Fasting Serum Insulin Like Growth Factor-1 (IGF-1) Levels||Screening, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
167532|NCT00163189|Other Pre-specified|Number of Participants Who Received Concomitant Medications||Baseline up to Month 60|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
167533|NCT00163189|Other Pre-specified|Number of Participants With at Least 1 Medical or Surgical History||Screening|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
167535|NCT00163189|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs include both SAEs and non-SAEs.|Baseline up to 28 days after last study treatment|Safety analysis set included all participants (including a site with GCP issues) who had received at least 1 study dose of GH.||participants|||Number
167536|NCT00163189|Secondary|Ratio of Bone Age (BA) to Chronological Age (CA)|BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray – Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||ratio||Standard Deviation|Mean
167537|NCT00163189|Secondary|Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60|BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||months||Standard Deviation|Mean
167538|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
167539|NCT00163189|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 12, 24, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
167540|NCT00163189|Secondary|Change From Baseline in Height at Month 12, 24, 36, 48 and 60|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||cm||Standard Deviation|Mean
167541|NCT00163189|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||kg/m^2||Standard Deviation|Mean
167542|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)|GR SDS CA Yx = (GR Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
167543|NCT00163189|Secondary|Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)|GR SDS BA Yx = (GR Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.|Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
167544|NCT00163189|Secondary|Annual Growth Rate (AGR)|AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y[x-1] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y[x-1]) and height recorded at Yx (AGR Yx = [height Yx–height Y{x-1}] / ([date of Yx – date of Y{x-1}] /365.25). Yx refers to the value at particular timepoint x.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||cm/year||Standard Deviation|Mean
167623|NCT00162266|Primary|Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
167627|NCT00162266|Primary|Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period||Day 360 to Day 3060|All treated OL participants.||Participants|||Number
167545|NCT00163189|Secondary|Mean Height Standard Deviation Score (SDS) for Bone Age (BA)|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx – reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||SDS||Standard Deviation|Mean
167546|NCT00163189|Secondary|Mean Height|The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.|Baseline, Month 12, 24, 36, 48, 60|"FAS included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||centimeters (cm)||Standard Deviation|Mean
167547|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 36|"PP analysis set included all participants (excluding a site with GCP issues) who received at least 1 dose of GH, had at least 1 subsequent rating of height, no major protocol violation till first 3 years post initiation of treatment and total GH treatment duration of 36 months or more. n=participants evaluable at the specified time point."||SDS||Standard Deviation|Mean
167548|NCT00163189|Primary|Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population|Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx – reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement–Date of birth)/365.25*12.|Baseline, Month 36|"Full analysis set (FAS) included all participants (excluding a site with GCP issues) who had received at least 1 injection of GH and had at least 1 post-Baseline measurement of height. Here n signifies those participants who were evaluable for the specified time point."||Standard Deviation Score (SDS)||Standard Deviation|Mean
167549|NCT00163020|Primary|Perinatal Death|Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.|measured from randomization to 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(156))||Twins|||Number
167550|NCT00163020|Secondary|Participant Side Effects Requiring Cessation of Therapy|Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy.|anytime from initial injection to final injection at 34 weeks.|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)||participants|||Number
167551|NCT00163020|Secondary|Participant Drop-out Rates|Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy).|any time from randomization to completion of final dose of study medication|Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)||participants|||Number
167552|NCT00163020|Secondary|Newborn Birthweight|Newborn Birthweight within the twins group was measure following delivery and noted in grams.|measure following delivery|Population analysed were twins from twin pregnancies (ie. active group 160 and placebo group 80)||grams||Standard Deviation|Mean
167553|NCT00163020|Secondary|Newborn Gestational Age (GA) at Delivery|Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth.|determined at the time of birth|Population analysed were total pregnant mothers with twin gestations (ie. active group 160 and placebo group 80)||weeks of age for twin pregnancy||Standard Deviation|Mean
167554|NCT00163020|Secondary|Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks|Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks)|noted at delivery|Population analysed were total pregnant mothers with triplet gestations (ie. active group 160 and placebo group 80)||Triplet Pregnancies|||Number
167555|NCT00163020|Secondary|Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks|Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks)|Gestational age noted at time of birth|Population analysed were total pregnancies of mothers with twin gestation (ie. active group 160 and placebo group 80)||Twin Pregnancies|||Number
167556|NCT00163020|Secondary|Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)|Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death).|measured as any event noted in the first 28 day following birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(155))||Twins - Components of Neonatal Morbidity|||Number
167557|NCT00163020|Primary|Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver|Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).|measured during the first 28 days after delivery|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (274) vs. babies born to mothers in placebo arm(130))||Twins|||Number
167558|NCT00163020|Primary|Newborn Retinopathy of Prematurity (ROP)|Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.|measured during the first 28 day after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(145))||Twins|||Number
167559|NCT00163020|Primary|Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery|Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.|measured in the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (315) vs. babies born to mothers in placebo arm(152))||Twins|||Number
167560|NCT00163020|Primary|Newborn Periventricular Leukomalacia (PVL)|Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.|measured in the first 28 days after birth.|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participants for analysis was determined using an intention to treat protocol.||participants|||Number
167561|NCT00163020|Primary|Newborn Intraventricular Hemorrhage Grade 3 or 4|"Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation.~Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension."|measured during the first 28 days after birth|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (316) vs. babies born to mothers in placebo arm(152))||Twins|||Number
167562|NCT00163020|Primary|Newborn Pneumonia|Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia|measure during the first 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(154))||Twins|||Number
167563|NCT00163020|Primary|Newborn Sepsis|Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.|measured during the first week following birth|The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participated included were based on an intent to treat protocol.||participants|||Number
167564|NCT00163020|Primary|Use of Oxygen Therapy at 28 Days of Newborn Life|Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.|Measured at 28 days after birth.|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(150))||Twins|||Number
167565|NCT00163020|Primary|Newborn Respiratory Distress Syndrome (RDS)|"Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support.~Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher’s Exact Test was used.~Morbidity measures were based on live births with data available for the outcomes."|Measured from delivery until 30 days after baby was discharged from the hospital|Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (319) vs. babies born to mothers in placebo arm(153))||Twins|||Number
167566|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 7|MITT population, baseline evaluations compared to Week 7 evaluations.||participants|||Number
167567|NCT00162981|Primary|A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and the 4-week maintenance period|MITT population||Percent Reduction||Full Range|Median
167568|NCT00162981|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.|"The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Week 3|MITT population, baseline evaluations compared to Week 3 evaluations.||participants|||Number
167569|NCT00162981|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period|||Percent of participants|||Number
167570|NCT00162981|Primary|Percent Reduction in Number of Drop Seizures.|Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.|4-week baseline period and 4-week maintenance period|Modified Intention-to-Treat (MITT) populations consist of all randomized patients who received study medication and who have both a baseline and post-baseline measurement and have at least one measurement during the maintenance period.||Percent Reduction||Standard Deviation|Mean
168730|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6|Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6|Month 6|||L||Standard Error|Mean
167571|NCT00162942|Post-Hoc|Clinical Response Based on no Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who did not use 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
167572|NCT00162942|Post-Hoc|Clinical Response Based on Use of 5-Aminosylisalates During the Study|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who used 5-aminosylisalates during the study were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medication were considered a treatment failure.||percentage of participants|||Number
167573|NCT00162942|Post-Hoc|Clinical Response Based on No Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and who have not used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
167574|NCT00162942|Post-Hoc|Clinical Response Based on Previous Use of Tumor Necrosis Factor-Alpha (TNF-a) Inhibitors|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and previously used TNFa-inhibitors were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
167575|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Less Than or Equal to 300|A clinical response is defined as a 70-point decrease in CDAI score|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score less than or equal to 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
167576|NCT00162942|Post-Hoc|Clinical Response in Subjects With a CDAI Score Greater Than 300|A clinical response is defined as a 70-point decrease in CDAI score.|Baseline to Week 12|All subjects who received at least one apheresis treatment session and had a CDAI score greater than 300 at baseline were included in the analysis population. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
167577|NCT00162942|Secondary|Mean Change in C-Reactive Protein||Baseline to week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 value or Last Observation Carried Forward was used for the analysis.||milligrams/liter||Standard Deviation|Mean
167578|NCT00162942|Secondary|Mean Change in Subject Global Rating|7-point,ordinal scale that measures the subject's state of Crohn's Disease from 0 (totally inactive) to 7 (as bad as it gets), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167579|NCT00162942|Secondary|Mean Change in Crohn's Disease Endoscopic Index of Severity|26-point,ordinal scale that assesses the severity of Crohn's Disease from 0 (least severe) to 26 (most severe), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|Endoscopic evaluations were to be performed at baseline and Week 12 on a subset of study subjects.||units on a scale||Standard Deviation|Mean
167580|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (WLQ Index)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167581|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Output Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167582|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167583|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Physical Demands)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
168936|NCT00142818|Primary|Number of Days of Abstinence From Drinking and Number of Days of Clinically Significant Drinking (Measured by Timeline Follow Back at Week 14 and the 6-month Evaluation)||4+13 weeks||||||
167584|NCT00162942|Secondary|Mean Change in Work Limitations Questionnaire (Time Management)|101-point, ordinal scale which measures the degree to which health problems interfere with certain aspects of job performance and productivity from 0 (limited none of the time) to 100 (limited all the time), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167585|NCT00162942|Secondary|Mean Change in EuroQol Score (Visual Analog Scale)|101-point, ordinal scale which measures non-disease specific health-related quality of life from 0 (Worst imaginable health state) to 100 (best imaginable health state)|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167586|NCT00162942|Secondary|Mean Change in EuroQol Score (Single Index)|A continuous scale that is a cardinal index of health from 0 (no impairment) to 1 (most impairment), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167587|NCT00162942|Secondary|Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)|193-point, ordinal scale measuring disease-specific quality of life from 32 (low quality of life) to 224 (high quality of life). Mean change= Week 12 Mean-Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167588|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167589|NCT00162942|Secondary|Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score|101-point, ordinal scale measuring general health of patients from 0 (low quality of life) to 100 (high quality of life), Mean change=Week 12 Mean -Baseline Mean|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score or Last Observation Carried Forward was used for the analysis.||units on a scale||Standard Deviation|Mean
167590|NCT00162942|Secondary|Clinical Response|Clinical Response is defined as a ≥ 100-point reduction in the CDAI scores at Week 12|Baseline to Week 12|All subjects who received at least one apheresis session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 CDAI score or Last Observation Carried Forward was used for the analysis. Subjects with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
167591|NCT00162942|Secondary|CDAI Score Change From Baseline|601-point, ordinal scale which quantifies the symptoms of patients with Crohn's Disease from 0 (complete remission) to 600 (most severe active disease). Mean change=Week 12 Mean CDAI-Baseline Mean CDAI|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis. The week 12 score was used for the analysis. If no week 12 score, then the week 9 score was be used. If no week 9 score, the subject was considered a treatment failure.||units on a scale||Standard Deviation|Mean
167592|NCT00162942|Primary|Frequency and Severity of Adverse Events Through Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.|Baseline through Week 12 Visit|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.||percentage of participants|||Number
167593|NCT00162942|Primary|Clinical Remission|Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12|Baseline to Week 12|All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT was used for effectiveness analysis. The week 12 CDAI score was used for the analysis. Subjects without a week 12 CDAI score or with a major violation on prohibited medications were considered a treatment failure.||percentage of participants|||Number
167594|NCT00162370|Secondary|Determine the Cost-effectiveness of Using Stress Echocardiography in Screening Peri- and Post-menopausal Women at Intermediate Risk for Coronary Artery Disease.||End of Study||||||
167595|NCT00162370|Secondary|Determine the Relative Values of Exercise Echocardiography, Exercise ECG Testing, Cardiac Peptides and Brachial Artery Reactivity for Identifying Patients at Risk of Cardiac Events.||End of Study||||||
167596|NCT00162370|Secondary|Determine the Value of Brachial Artery Reactivity for Identifying Patients With Cardiac Events During Follow-up.||End of Study||||||
167597|NCT00162370|Secondary|Determine the Value of Exercise Induced Changes in Levels of Cardiac Peptides; Brain Natriuretic Peptide (BNP) in Identifying Patients With Cardiac Events During Follow-up.||2 year or 5 year follow up||||||
167598|NCT00162370|Secondary|Percent of Subjects With Abnormal Stress ECG Testing for Identifying Patients With Major Adverse Cardiac Events (MACE)|Stress ECG test interpretation will be summarized using number and percentage of patients with normal and abnormal ECG with and without MACE|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up||percent of MACE|||Number
168130|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.|56 months|FAS of the ONTARGET trial||participants|||Number
167599|NCT00162370|Primary|Percentage of Low to Intermediate Risk Patients Experiencing Future Major Adverse Cardiac Events (MACE)|Determine the prognostic value of stress echocardiography as a screening examination in peri- or post-meopausal female patients with an intermediate pre-test likelihood of coronary artery disease (CAD) to identify patients at higer risk of experiencing future cardiac events.|2 or 5 year follow up|Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up||% of subjects with MACE|||Number
167600|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167601|NCT00162266|Secondary|Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167602|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167603|NCT00162266|Secondary|Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167604|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167605|NCT00162266|Secondary|Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167606|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167607|NCT00162266|Secondary|Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167608|NCT00162266|Secondary|Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167609|NCT00162266|Secondary|Mean BL General Health Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167610|NCT00162266|Secondary|Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.|BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167611|NCT00162266|Secondary|Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167612|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167613|NCT00162266|Secondary|Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167624|NCT00162266|Secondary|Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||pg/mL||Standard Deviation|Mean
167614|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167615|NCT00162266|Secondary|Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167616|NCT00162266|Secondary|Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.|Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167617|NCT00162266|Secondary|Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period|SF-36=PCS, MCS, & 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, & mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values & post-baseline (BL) values are presented for each post-BL visit & represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167618|NCT00162266|Secondary|Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period|The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
167619|NCT00162266|Secondary|Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period|SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
167620|NCT00162266|Secondary|Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period|Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
167621|NCT00162266|Secondary|Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period|Serum evaluations were carried out to evaluate participant serum CRP concentrations at baseline. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
167622|NCT00162266|Secondary|Mean Change From Baseline in sIL2-r Over Time in OL Period|Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||pg/mL||Standard Error|Mean
167628|NCT00162266|Primary|Mean Change From Baseline (BL) in IgM in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
167629|NCT00162266|Secondary|Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period|Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||IU/mL||Standard Error|Mean
167630|NCT00162266|Secondary|Baseline Level of Serum Rheumatoid Factor Over Time in OL Period|Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.|Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point.||IU/mL||Standard Deviation|Mean
167631|NCT00162266|Secondary|Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period|The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.|Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N =number of participants analyzed; n=the number of participants with measurements for that time point.||Participants|||Number
167632|NCT00162266|Secondary|Number of ACR 70 Responders in the OL Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.||Participants|||Number
167633|NCT00162266|Secondary|Number of ACR 50 Responders in the OL Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point.||Participants|||Number
167634|NCT00162266|Secondary|Number of ACR 20 Responders in OL Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060|All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
167635|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||ng/mL||95% Confidence Interval|Mean
167636|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||ng/mL||95% Confidence Interval|Mean
167637|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||ng/mL||95% Confidence Interval|Mean
167638|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||pg/mL||95% Confidence Interval|Mean
167639|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||pg/mL||95% Confidence Interval|Mean
167640|NCT00162266|Secondary|Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360||Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||IU/mL||95% Confidence Interval|Mean
167641|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||participants|||Number
167642|NCT00162266|Primary|Baseline Immunoglobulin M (IgM) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10.|Baseline (Day 0) and Days 360, 720,1080,1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
167643|NCT00162266|Primary|Mean Change From Baseline (BL) in IgG Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
167644|NCT00162266|Primary|Baseline Immunoglobulin G (IgG) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8.|Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
167645|NCT00162266|Secondary|Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)|Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.|Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||participants|||Number
167646|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||titers||Standard Deviation|Geometric Mean
167647|NCT00162266|Secondary|Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region||Baseline, Days 30, 90, 180, 270, 360|Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint.||titers||Standard Deviation|Geometric Mean
167648|NCT00162266|Secondary|Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods||Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period)|Treated Participants||participants|||Number
167649|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.||Participants|||Number
167650|NCT00162266|Primary|Mean Change From Baseline (BL) in IgA Over Time in OL Period|Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5.|Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
167651|NCT00162266|Primary|Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period|Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6.|Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800|All treated OL participants. Participants were grouped according to the treatment they received in DB study. n=the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
167652|NCT00162266|Primary|Number of Participants With AEs of Special Interest in OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest were those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion.|Day 360 to Day 3060|All treated OL participants.||Participants|||Number
167653|NCT00162266|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug.|Day 360 to Day 3060|All treated OL participants.||Participants|||Number
167654|NCT00162266|Primary|Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period|The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics.|Day 360 to Day 3,060|All treated participants.||Participants|||Number
167655|NCT00162266|Secondary|Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy||From the start of study up to 60 days post the end of the 12-month double-blind period|Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement.||Participants|||Number
167656|NCT00162266|Secondary|Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.|From the start of study through the end of the double-blind period (at 12 months)|All treated participants||Participants|||Number
167657|NCT00162266|Secondary|Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360||Day 180, Day 360|All treated participants||participants|||Number
167658|NCT00162266|Secondary|Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360|A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||Percentage of Change on mHAQ scale||Standard Error|Mean
167659|NCT00162266|Secondary|Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.|Baseline, Day 180, Day 360|Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint.||units on a scale||Standard Error|Mean
167660|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360|Percentage change = 100*(Baseline value – value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 360|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.||percentage change||Standard Error|Mean
167661|NCT00162266|Secondary|Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180|Percentage change = 100*(Baseline value – value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])|Baseline, Day 180|Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points.||percentage change||Standard Error|Mean
167662|NCT00162266|Secondary|ACR-N Area Under The Curve (AUC) on Day 180 and Day 360|The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.|Baseline and Day 180; Baseline and Day 360|||percentage*days||Standard Error|Mean
167663|NCT00162266|Secondary|ACR Numeric Values (ACR-N)|The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication||units on a scale||Standard Deviation|Mean
167664|NCT00162266|Secondary|Number of ACR 70 Responders in DB Period|ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication||Participants|||Number
167665|NCT00162266|Secondary|Number of ACR 50 Responders in DB Period|ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360|Participants who received at least 1 infusion of study medication||Participants|||Number
167666|NCT00162266|Secondary|Number of ACR 20 Responders in DB Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360|Participants who received at least 1 infusion of study medication||Participants|||Number
167667|NCT00162266|Primary|Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 180|Intent-to-treat population. Participants who discontinued the study due to lack of efficacy (ie, worsening rheumatoid arthritis) were considered ACR 20 nonresponders at all subsequent time points. For all subjects who discontinued for other reasons, their last ACR 20 response was carried forward.||Participants|||Number
167668|NCT00162136|Secondary|Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.|At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.|||Participants|||Number
167669|NCT00162136|Secondary|Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level|Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)|through 72 hours after start of infusion|All participants treated at the 40 mg/m2 dose level.||ng/mL||Standard Deviation|Mean
167670|NCT00162136|Secondary|Hematology Results - Worst On-Study Grade|Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.|||Participants|||Number
167671|NCT00162136|Secondary|Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).|From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.|||Participants|||Number
167672|NCT00162136|Primary|Number of Participants With Dose Limiting Toxicities at Dose Level|Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.|Measures taken at Cycle 01 (21-day cycle)|All treated participants||participants|||Number
167673|NCT00162123|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.|From day of first reinduction in current study to date of progression or death, whichever occurred first.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study||Months||95% Confidence Interval|Median
167674|NCT00162123|Secondary|Number of Participants With On-study Immune-related Adverse Events (irAEs)|irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.|From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study 10 mg/kg current study||Participants|||Number
167675|NCT00162123|Secondary|Percentage of Participants Surviving at 1, 1.5, and 2 Years|Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.|From first dose of study drug in parent study to up to 2 years after reinduction|All participants who received study drug as reinduction or extended maintenance from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study and those patients who were followed-up.||Percentage of participants|||Number
167676|NCT00162123|Secondary|Overall Survival (OS)|OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.|From first dose of study drug in parent study to death or date of last censoring.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study||Months||95% Confidence Interval|Median
167688|NCT00162097|Primary|Minimum Plasma Concentration (Cmin)|Cmin was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||mcg/mL||Full Range|Geometric Mean
167677|NCT00162123|Primary|Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.|All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study||Participants|||Number
167678|NCT00162097|Secondary|Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1)|The physical examination included an evaluation of the participant's height and body mass index (BMI) (at screening only), and weight. Abnormal physical examination are findings that are clinically meaningful by the judgment of the investigator|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis. Physical examination findings were not analysed at discharge.||participants|||Number
167679|NCT00162097|Secondary|Number of Participants With Clinically Meaningful Vital Signs Measures|Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. The investigator used his/her clinical judgement to decide whether or not abnormalities in vital signs were clinically meaningful.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
167680|NCT00162097|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||hours||Full Range|Median
167681|NCT00162097|Secondary|Number of Participants With Identified Electrocardiogram (ECG) Abnormalities|ECG abnormalities are findings that are clinically meaningful by the judgment of the investigator. A 12-lead ECG was performed and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
167682|NCT00162097|Secondary|Number of Participants With Urinalysis MAs|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following urinalysis MA definitions specify the criteria for MAs in the data presented. The presence of white blood cells (WBCs) and red blood cells (RBCs) in the urine was graded on a scale: 0 = no cells present (negative); trace =a small number of cells present; then 1+, 2+, 3+ and 4+, denoting increasingly “positive” urine results (ie, WBCs/RBCs present in the urine). The MA for both WBCs and RBCs was >= 2+ (or, if pre-treatment value >=2+, then >= 4+).|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.||participants|||Number
167683|NCT00162097|Secondary|Number of Participants With Serum Chemistry MAs|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify the criteria for MAs in the data presented. High bilirubin (total): >1.1 x ULN (or if pre-treatment value >ULN, then >1.25 x pre-treatment value). High creatinine: >1.33 x pre-treatment value. Low albumin: <0.9 x LLN (or if pre-treatment value <LLN, then <0.9 x pre-treatment value). High amylase (total): >2 x pre-treatment value.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 were included in the analysis. The 'n' signifies those participants who received study drug and were evaluated for this measure, for each group respectively.||participants|||Number
167684|NCT00162097|Secondary|Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Low platelet count: <0.85 x lower limit of normal (LLN) (or if pre-treatment value <LLN, then <0.85 x pre-treatment value). Low leukocytes: <0.9 x LLN (or if pre-treatment value <LLN, then <0.85 x pre-treatment value. If pre-treatment value >upper limit of normal [ULN], then <LLN). Low neutrophils+bands (absolute): <=1.500 10^3 cells/microliter (uL). Low lymphocytes (absolute): <0.750 10^3 cells/uL.|Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.|All participants who received study drug on Day 1 and were evaluated for these measures.||participants|||Number
167685|NCT00162097|Secondary|Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product. Participants who discontinued the study due to an AE were recorded.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
167686|NCT00162097|Secondary|Number of Participants Who Experienced AEs|AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).|All participants who received study drug on Day 1 were included in the analysis.||participants|||Number
167687|NCT00162097|Primary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])|The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||mcg*h/mL||Full Range|Geometric Mean
167689|NCT00162097|Secondary|Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)|An SAE was defined as any adverse event (AE) occurring at any dose that; resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose.|From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.|All data from participants who signed the informed consent and enrolled in the study is included in the data set used for evaluating SAEs.||Participants|||Number
167690|NCT00162097|Primary|Maximum Plasma Concentration (Cmax)|Cmax was obtained directly from the concentration-time data.|Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.|The analysis was performed per protocol.||micrograms (mcg)/mL||Full Range|Geometric Mean
167691|NCT00162032|Secondary|In Addition, a Determination of the Safety of Sestamibi Will be Evaluated at the End of the Study Through Adverse and Serious Adverse Events Reported and Evaluating Vital Signs, ECGs, Physical Exams and Laboratory Tests for Each Subject.||3 year follow up||||||
167692|NCT00162032|Secondary|Concordance Will be Determined Between the Presence of Perfusion Abnormalities Detected on Sestamibi Images and the Classification of Ischemic Heart Disease.||3 year follow up||||||
167693|NCT00162032|Primary|Kawasaki Disease Population at High and Low Risk of Developing Cardiac Events Though Three Years Follow-up.|The proportion of all patients who experienced cardiac events among patients with abnormal (SSS >=4, high risk) and normal (SSS <4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.|3 years|Had SPECT Myocardial perfusion imaging tests and experienced a cardiac event||proportion of participants||95% Confidence Interval|Number
167694|NCT00161616|Secondary|Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)|Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, “healed” (see primary outcome), and radiographically united by independent, blinded radiology panel, “united.” Patients deemed “not healed” or “not united” were assessed as failures.|1 year|All patients randomized were analyzed.||patients|||Number
167695|NCT00161616|Primary|Number of Patients With Healed Fractures|Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed.|13 and 20 weeks|All patients randomized were analyzed.||patients|||Number
167696|NCT00161473|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation|"The Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates psychiatric symptoms. Each item ranges from 1 to 7. Therefore, the Brief Psychiatric Rating Scale total score ranges from a minimum of 0 to a maximum of 126, where 126 indicates higher levels of behavioral symptoms.~A change Brief Psychiatric Rating Scale score that is a negative number (that is, a Brief Psychiatric Rating Scale score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.~The mean group change was determined by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."||units on a scale||Standard Deviation|Mean
167697|NCT00161473|Secondary|Number of Behavioral Assessment Visits Completed|This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.|Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)|||number of visits||Standard Deviation|Mean
167698|NCT00161473|Primary|Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation|"The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms.~A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement."|Weeks 2, 4, 6, and 8 (change from Baseline)|"Participants with at least one follow-up behavioral assessment visit were included in this analysis.~The mean group change was calculated by calculating the mean of each participant's follow-up measures, subtracting this mean from the baseline value, and then from these values, calculating group means and standard deviations."||units on a scale||Standard Deviation|Mean
167699|NCT00161473|Primary|Mean Clinical Global Impression of Change (CGIC) at Last Observation|"The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates markedly improved, 4 indicates no change, and 7 indicates markedly worse."|Week 8|Participants with at least one follow-up behavioral assessment visit were included in this analysis||units on a scale||Standard Deviation|Mean
167700|NCT00161382|Secondary|Proportion of Students That Are Sexually Active||Measured over a period of 30 days||||||
167701|NCT00161382|Secondary|Communication With Parents||Measured throughout the study||||||
167702|NCT00161382|Secondary|Barriers||Measured throughout the study||||||
167703|NCT00161382|Secondary|Perceived Norms||Measured throughout the study||||||
167704|NCT00161382|Secondary|Attitudes||Measured throughout the study||||||
167705|NCT00161382|Secondary|Self-efficacy||Measured throughout the study||||||
167706|NCT00161382|Secondary|Knowledge||Measured throughout the study||||||
167797|NCT00159965|Secondary|Oxford Handicap Scale (OHS)|"The OHS is a brief clinician scored assessment of symptoms and lifestyle interference and the 6 grades of disability are based on the modified Rankin Scale, ranging from 0 (no symptoms) to 5 (severe handicap). A higher score relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
167707|NCT00161382|Primary|Initiation of Sexual Intercourse|The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.|Measured throughout the study, and at 2006/2007 school year|||participants|||Number
167708|NCT00161213|Secondary|Overall Survival||5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.||months||95% Confidence Interval|Median
167709|NCT00161213|Secondary|1-year Survival Rate|Percentage of subjects who survive up to 1 year|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.||percentage of total evaluable subjects||95% Confidence Interval|Number
167710|NCT00161213|Secondary|Response Rate|"Response rate as defined by a best response of Stable Disease or better."|5 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response. Seven subjects were not assessed for response as they discontinued therapy treatment before response was assessed.||percentage of total evaluable subjects||95% Confidence Interval|Number
167711|NCT00161213|Primary|Progression-free Survival|Progression-free survival in months.|4 years|A total of 44 patients were enrolled. One patient withdrew consent before starting treatment. One patient was determined, after initiating treatment, to have an ampullary cancer and was evaluable for toxicity but not for response.||months||95% Confidence Interval|Median
167712|NCT00160706|Secondary|Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256||Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 280 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||µg/g stool||95% Confidence Interval|Geometric Mean
167713|NCT00160706|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||mg/L||95% Confidence Interval|Geometric Mean
167714|NCT00160706|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)|Of the 310 subjects in the Safety Population, 309 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
167715|NCT00160706|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|Of the 310 subjects in the Safety Population, 307 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||µg/mL||95% Confidence Interval|Geometric Mean
167716|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 299 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
167717|NCT00160706|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change ≥ 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)|Of the 309 subjects in the Intention-To-Treat (ITT) Population, 307 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
167798|NCT00159965|Secondary|Symptom Checklist 90 (SCL-90)|"The SCL-90 is a 90 item self-report clinical rating scale oriented toward symptomatic behavior of outpatients, assessing from 0 (not at all bothered) to 4 (extremely bothered). The highest possible overall score is 360 and relates to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
167718|NCT00160706|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 362) / (Early) Withdrawal Visit|All 309 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
167719|NCT00160706|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
167720|NCT00160706|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)|All 310 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
167721|NCT00160693|Secondary|Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years|This Secondary Outcome Measure shows additional arthritis medications received by at least 20% of subjects during the 8-year study.|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).||percentage of subjects|||Number
167722|NCT00160693|Secondary|Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years||From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).||percentage of subjects|||Number
167723|NCT00160693|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Of the 402 subjects in the Safety Set (SS), 400 subjects are included in this analysis, because they had available data at Baseline and Completion or early Withdrawal Visit.||units on a scale||Standard Deviation|Mean
167724|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 70% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 70% or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).||percentage of subjects||95% Confidence Interval|Number
167725|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 50% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 50% or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).||percentage of subjects||95% Confidence Interval|Number
167726|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit|The assessments are based on a 20% or greater improvement from Baseline to the Completion Visit or early Withdrawal Visit in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years|Safety Set (SS).||percentage of subjects||95% Confidence Interval|Number
167735|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.||units on a scale||Standard Deviation|Mean
167727|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316|"The assessments are based on a 20% or greater improvement from Baseline to Week 316 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 316|Of the 402 subjects in the Safety Set (SS), 140 subjects are included in this analysis, because they had available data at Baseline and Week 316.||percentage of subjects||95% Confidence Interval|Number
167728|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256|"The assessments are based on a 20% or greater improvement from Baseline to Week 256 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 256|Of the 402 subjects in the Safety Set (SS), 211 subjects are included in this analysis, because they had available data at Baseline and Week 256.||percentage of subjects||95% Confidence Interval|Number
167729|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208|"The assessments are based on a 20% or greater improvement from Baseline to Week 208 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 208|Of the 402 subjects in the Safety Set (SS), 223 subjects are included in this analysis, because they had available data at Baseline and Week 208.||percentage of subjects||95% Confidence Interval|Number
167730|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160|"The assessments are based on a 20% or greater improvement from Baseline to Week 160 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 160|Of the 402 subjects in the Safety Set (SS), 247 subjects are included in this analysis, because they had available data at Baseline and Week 160.||percentage of subjects||95% Confidence Interval|Number
167731|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100|"The assessments are based on a 20% or greater improvement from Baseline to Week 100 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 100|Of the 402 subjects in the Safety Set (SS), 275 subjects are included in this analysis, because they had available data at Baseline and Week 100.||percentage of subjects||95% Confidence Interval|Number
167732|NCT00160693|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52|"The assessments are based on a 20% or greater improvement from Baseline to Week 52 in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient’s Global Assessment of Disease Activity (PtGADA), Physician’s Global Assessment of Disease Activity (PhGADA), Patient’s Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire – Disability Index (HAQ-DI) and C-Reactive Protein (CRP).~Baseline is Baseline of the respective feeder study."|From Baseline to Week 52|Of the 402 subjects in the Safety Set (SS), 370 subjects are included in this analysis, because they had available data at Baseline and Week 52.||percentage of subjects||95% Confidence Interval|Number
167733|NCT00160693|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From First Visit (Week 0 in this study) up to 8 years|Safety Set (SS).||percentage of subjects|||Number
167734|NCT00160693|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.~First dose of CZP was at Baseline of one of the feeder studies C87011 [NCT00548834] or C87014 [NCT00544154] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP up to 8 years|Safety Set (SS).||percentage of subjects|||Number
167799|NCT00159965|Secondary|Dissociative Experiences Scale (DES)|The DES is a 28 item self-report questionnaire designed to quantify dissociative experiences which identifies disturbances in memory, identity, cognition, derealization, depersonalization, absorption and imagination. A visual analogue scale is used ranging from 0% (“This never happens to you”) to 100% (“This always happens to you”). The score is divided by 28 items to yield a range of 0 to 100%, with a higher score relating to a higher degree of dissociation.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||units on a scale||Standard Deviation|Mean
167736|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score|The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 527 are included in this analysis. Data not available for 40 subjects.||units on a scale||Standard Deviation|Mean
167737|NCT00160641|Secondary|Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit|Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.||percentage of participants|||Number
167738|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/ hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 556 are included in this analysis. Data not available for 11 subjects.||units on a scale||Standard Deviation|Mean
167739|NCT00160641|Secondary|Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness|Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 563 are included in this analysis. Data not available for 4 subjects.||hours||Standard Deviation|Mean
167740|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score|The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 560 are included in this analysis. Data not available for 7 subjects.||units on a scale||Standard Deviation|Mean
167741|NCT00160641|Secondary|Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline of the preceding double-blind study to Week 104 of the open-label study|Of the 567 subjects in the Safety Set (SS), 423 are included in this analysis. Data not available for 144 subjects.||units on a scale||Standard Deviation|Mean
167742|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal|The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.||percentage of participants||95% Confidence Interval|Number
167743|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244|The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.||percentage of participants||95% Confidence Interval|Number
167779|NCT00160251|Secondary|Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period|"All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.~The dosing interval of 8 hours is represented as the hr in the unit of measure."|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.||ng*hr/mL||Standard Error|Mean
167744|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196|The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.||percentage of participants||95% Confidence Interval|Number
167745|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148|The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.||percentage of participants||95% Confidence Interval|Number
167746|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100|The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.||percentage of participants||95% Confidence Interval|Number
167747|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.||percentage of participants||95% Confidence Interval|Number
167748|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal|The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.||percentage of participants||95% Confidence Interval|Number
167749|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244|The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.||percentage of participants||95% Confidence Interval|Number
167750|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196|The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.||percentage of participants||95% Confidence Interval|Number
167780|NCT00160251|Secondary|Peak Plasma Concentration of Boceprevir (BOC)|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.||ng/mL||Standard Error|Mean
167751|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148|The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.||percentage of participants||95% Confidence Interval|Number
167752|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100|The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.||percentage of participants||95% Confidence Interval|Number
167753|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.||percentage of participants||95% Confidence Interval|Number
167754|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal|The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)|Of the 567 subjects in the Safety Set (SS), 565 are included in this analysis. Data not available for 2 subjects.||percentage of participants||95% Confidence Interval|Number
167755|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244|The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 244 of the open-label study|Of the 567 subjects in the Safety Set (SS), 72 are included in this analysis. Data not available for 495 subjects.||percentage of participants||95% Confidence Interval|Number
167756|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196|The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 196 of the open-label study|Of the 567 subjects in the Safety Set (SS), 367 are included in this analysis. Data not available for 200 subjects.||percentage of participants||95% Confidence Interval|Number
167757|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148|The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 148 of the open-label study|Of the 567 subjects in the Safety Set (SS), 410 are included in this analysis. Data not available for 157 subjects.||percentage of participants||95% Confidence Interval|Number
167781|NCT00160251|Secondary|Percent of Participants With Virologic Response Prior to Amendment 2|Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.|Week 3, Week 5, Week 13|||Percent of participants|||Number
168021|NCT00153920|Secondary|Any Grade Sensory Neuropathy Events|Any grade sensory neuropathy events based on CTCAEv3 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||adverse events|||Number
167758|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100|The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 100 of the open-label study|Of the 567 subjects in the Safety Set (SS), 442 are included in this analysis. Data not available for 125 subjects.||percentage of participants||95% Confidence Interval|Number
167759|NCT00160641|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.|From Baseline of the preceding double-blind study to Week 52 of the open-label study|Of the 567 subjects in the Safety Set (SS), 493 are included in this analysis. Data not available for 74 subjects.||percentage of participants||95% Confidence Interval|Number
167760|NCT00160641|Primary|Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study|"An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device.~The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms."|From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)|Safety Set||percentage of participants|||Number
167761|NCT00160641|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|"A SAE is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalisation or prolongation of existing hospitalisation~Results in persistent or significant disability/incapacity, or~Is a congenital anomaly or birth defect~Is as infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above~First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo."|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set||percentage of participants|||Number
167762|NCT00160641|Primary|Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years|An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.|From first dose of CZP to the end of the open-label study (approximately 6.8 years)|Safety Set||percentage of participants|||Number
167763|NCT00160563|Secondary|Time to Onset of Asthma in the Subset of Subjects Still Asthma Free After First 18 Months.||18 months (from the end of the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.|||||
167764|NCT00160563|Primary|Time to Onset of Asthma||36 months (from the randomization visit to the preceding A00309 - NCT00152464 trial onwards.)|Analysis was not performed due to premature discontinuation of the study.|||||
167765|NCT00160524|Secondary|Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258||Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||μg/g stool||95% Confidence Interval|Geometric Mean
167766|NCT00160524|Secondary|C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit||Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||mg/L||95% Confidence Interval|Geometric Mean
167767|NCT00160524|Secondary|Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033|Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)|Of the 595 subjects in the Safety Population, 593 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
167768|NCT00160524|Secondary|Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit|Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 595 subjects in the Safety Population, 590 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||μg/mL||95% Confidence Interval|Geometric Mean
168731|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1|Month 1|||L||Standard Error|Mean
167769|NCT00160524|Secondary|Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032|Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.|From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit|All 594 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
167770|NCT00160524|Secondary|Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit|HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.|Study Completion Visit (Week 364) / (Early) Withdrawal Visit|Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.||percentage of subjects||95% Confidence Interval|Number
167771|NCT00160524|Primary|Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)|An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
167772|NCT00160524|Primary|Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)|All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 [NCT00152490] or C87032 [NCT00152425].||percentage of subjects|||Number
167773|NCT00160251|Primary|Percent of Participants Who Achieved Sustained Virologic Response (SVR)|"SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed."|Baseline up to Week 73 [24 weeks after end of treatment (EoT)]|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.||Percent of participants|||Number
167774|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73) (up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.||Participants|||Number
167775|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.||Participants|||Number
167776|NCT00160251|Secondary|Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])|Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).|From dosing change to end of follow-up (Week 73)(up to 48 weeks)|All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV_RNA ≤ 10,000 IU) switched to continuing triple therapy.||Participants|||Number
167777|NCT00160251|Secondary|Change in Alanine Aminotransferase (ALT) Levels|Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.|Baseline up to dosing change (> 25 weeks)|Only participants with at least one value for the laboratory test were included.||Participants|||Number
167778|NCT00160251|Secondary|Trough Plasma Concentration Level|All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.|All visits during treatment (baseline to Week 49) except Day 1 of Week 1|Participants were only included in the analysis if the recorded previous dose of boceprevir was taken < 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.||ng/mL||Standard Error|Mean
167796|NCT00159965|Secondary|Clinical Global Impressions - Severity (CGI-S)|"The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal (1) to among the most extremely ill patients (7). A higher score relates to a higher severity of illness."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
167782|NCT00160251|Secondary|Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop|"For each log drop category (<0, 0 to 0.5, 0.5 to <1, 1 to <1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:~Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).~Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group."|Week 1 and Week 49|N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).||Percent of participants|||Number
167783|NCT00160251|Secondary|Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA|Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.|Baseline up to Week 73 [24 weeks after EoT]|Number of participants across all treatment arms who achieved negative HCV-RNA||Percent of participants|||Number
167784|NCT00160251|Primary|Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)|"Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.~All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.~For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.~Arm 1A was not analyzed."|Baseline up to Week 49|For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.||Percent of participants|||Number
167785|NCT00160199|Secondary|Time to Withdrawal Bleeding After Second Treatment Cycle|The number of days between the second cycle of treatment and the withdrawal bleeding|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
167786|NCT00160199|Secondary|Time to Withdrawal Bleeding After First Treatment Cycle|The number of days between the first cycle of treatment and the withdrawal bleeding.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
167787|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After Second Treatment Cycle|The numbers of days the subjects actually bled after the end of the second treatment cycle|End of the second cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
167788|NCT00160199|Secondary|The Duration of Withdrawal Bleeding After the First Treatment Cycle|The numbers of days the subjects actually bled after the end of the first treatment cycle.|End of the first cycle of treatment (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||Days||Standard Deviation|Mean
167789|NCT00160199|Secondary|Maximum Intensity of Withdrawal Bleeding After Any Cycle|The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy|Duration of withdrawal bleed|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||participants|||Number
167790|NCT00160199|Primary|Number of Subjects With Withdrawal Bleeding|This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.|After first and second cycle (cycle=28 days)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||participants|||Number
167791|NCT00160199|Primary|Secretory Conversion of the Endometrium|Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.|End of the study (Days 85)|The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated.||participants|||Number
167792|NCT00159965|Secondary|Quality of Life in Epilepsy-31 (QOLIE-31)|This is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
167793|NCT00159965|Secondary|Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|"The LIFE-RIFT interview is a brief semi-structured interview, which measures functional impairment, targeting four domains: work, interpersonal relations, recreation and global satisfaction. Work, recreation and global satisfaction are rated on a 1 (very good/ no impairment) to 5 (very poor/ severe impairment) scale, and interpersonal relations is rated on a 1 (very good) to 7 (variable) scale. The highest score possible is 20 and relates to a more severe impairment. The lowest possible score is 3."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
167794|NCT00159965|Secondary|Family Assessment Device (FAD)|"The FAD is a 60 item self-report questionnaire designed to assess the six dimensions of the McMaster Model of Family Functioning, as well as overall level of family functioning through the General Functioning Scale. Each question is scored on a 1 to 4 scale, with a higher mean score relating to a worse general functioning."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||General Functioning Subscale Score||Standard Deviation|Mean
167795|NCT00159965|Secondary|Clinical Global Impressions - Improvement (CGI-I)|"The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved (1) to very much worse (7). A lower score represents a higher improvement."|Weeks 2, 6, 10|||Units on a scale||Standard Deviation|Mean
167800|NCT00159965|Secondary|Barratt Impulsivity Scale (BIS)|"The BIS is a 30 item self-report measure that characterizes four aspects of impulsiveness, and ranges from rarely/ never to almost always with a score of 1 to 4 possible on each question, giving a maximum possible score of 120 and minimum possible score of 30. Selected questions are reversed scored. Higher scores relate to a worse outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
167801|NCT00159965|Secondary|Davidson Trauma Scale (DTS)|The DTS is a 17-item self-report scale measuring each Diagnostic and Stastical Manual of Mental Disorders-4th Edition (DSM-IV) symptom of post-traumatic stress disorder (PTSD) on 5-point frequency (0-not at all to 4-everyday) and severity (0-not at all distressing to 4-extremely distressing) scales. The highest possible score is 136 and relates to the worst outcome.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||units on a scale||Standard Deviation|Mean
167802|NCT00159965|Secondary|Global Assessment of Functioning (GAF)|This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning of a subject during a specified time period on a continuum from psychological or psychiatric sickness to health.|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||Units on a scale||Standard Deviation|Mean
167803|NCT00159965|Secondary|Modified Hamilton Depression Scale (MHRS)|"The MHRS assesses the severity of Depression-related symptoms from 0 (not present) to 2, 3 or 4 (severe) on each question. The highest possible score is 72, relating to the worst outcome."|Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)|||units on a scale||Standard Deviation|Mean
167804|NCT00159965|Secondary|Beck Depression Inventory-II (BDI-II)|"The BDI-II assesses depression severity from 0 (no Depression-related symptom) to 3 (severe) on each question. The highest possible score is 51, relating to the worst outcome."|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12|||Units on a scale||Standard Deviation|Mean
167805|NCT00159965|Primary|Number of Nonepileptic Seizures (NES)|psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.|bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12|||seizures||Standard Deviation|Median
167806|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|Per Protocol Population||percent change||Standard Deviation|Mean
167807|NCT00159913|Secondary|Change From Baseline to Week 16 in World Health Organization (WHO) Pulmonary Hypertension (PH) Functional Class|WHO PH functional class definitions adapted from New York Heart Association Criteria for Functional Capacity and Therapeutic Class Definitions. Class I = PH without resulting limitation of physical activity, Class II = PH resulting in slight limitation of physical activity, Class III = PH resulting in marked limitation of physical activity, Class IV = PH with inability to carry out any physical activity without symptoms. Improved by 1 class = Class 4 to 3, Class 3 to 2, Class 2 to 1. Improved by 2 classes = Class 4 to 2, Class 3 to 1. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF||units|||Number
167808|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Psychosocial Scales|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5years with a valid questionnaire available in the subject's first language.||score on scale||Standard Deviation|Mean
167809|NCT00159913|Secondary|Change From Baseline to Week 16 in Child Health Questionnaire Parent Form (CHQ-PF28), Physical Scale|CHQ-PF28: validated generic Quality of Life (QoL) questionnaire for subjects >= 5 years. Includes 12 domain scores of QoL concepts including physical functioning, social & school activities, mental health, parent/family concepts. Scores range 0-100: lower scores = lower QoL. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, includes subjects >= 5 years with a valid questionnaire available in the subject's first language.||score on scale||Standard Deviation|Mean
167810|NCT00159913|Secondary|Change From Baseline to Week 16 in Right Atrial Pressure (RAP)|RAP was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for missing data.||mm Hg||Standard Deviation|Mean
167811|NCT00159913|Secondary|Change From Baseline to Week 16 in Cardiac Index (CI)|CI is observed value at Week 16 minus Baseline value. Calculated as cardiac output in systemic circulation (COsys) / body surface area (BSA).|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data.||liters/minute/meters squared||Standard Deviation|Mean
167812|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)|Change calculated as (mean PAP - PCWP)/COpulm in PVR is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using LOCF (end of treatment) approach for handling missing data||wood units||Standard Deviation|Mean
167813|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in Time to Maximum Volume of Oxygen Consumed (VO2)|Time to maximum VO2 was assessed on the subset of subjects who are developmentally able to perform the exercise test. Percent change is [(value at Week 16 minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.||percent change||Standard Deviation|Mean
167814|NCT00159913|Secondary|Percent Change From Baseline to Week 16 in: Respiratory Exchange Ratio (RER)|RER is the ratio of carbon dioxide produced to oxygen consumed [VCO2/VO2]). Percent change is [(Week 16 value minus Baseline value)/Baseline value] * 100%|Baseline, Week 16|ITT population, LOCF (end-of-treatment) approach for handling missing values.||percent change||Standard Deviation|Mean
167815|NCT00159913|Secondary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance Index (PVRI)|PVRI equals Pulmonary Vascular Resistance (PVR) times Body Surface Area (BSA). Wood unit = 80dyn•s/cm5. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, LOCF||wood units. m2||Standard Deviation|Mean
168732|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1|Estimated FEV1 before bronchodilator at Month 1|Month 1|||L||Standard Error|Mean
167816|NCT00159913|Secondary|Change From Baseline to Week 16 in Mean Pulmonary Artery Pressure (mPAP)|mPAP, a hemodynamic parameter, was measured using a pressure transducer positioned at the mid-axillary line with the patient in the supine position. Change is observed value at Week 16 minus Baseline value.|Baseline, Week 16|ITT population, using a LOCF (end-of-treatment) approach for handling missing data.||mm Hg||Standard Deviation|Mean
167817|NCT00159913|Primary|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population|Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = [(week 16 value minus baseline mean)/mean at baseline]*100%.|Baseline, Week 16|ITT population included all subjects randomised and who received at least one dose of study medication. All subjects developmentally able to perform the exercise test. Subjects assumed developmentally able if they had a CPX exercise assessment at any visit during study using a LOCF (end-of-treatment)approach for handling missing data.||percent change||Standard Deviation|Mean
167818|NCT00159874|Secondary|Physician Global Assessment at Year 1|The physician global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants with markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
167819|NCT00159874|Secondary|Participant (Parent) Global Assessment at Year 1|The participant (parent) global assessment of disease severity was assessed at Year 1 in this extension study. The number and percentage of participants markedly improved, moderately improved, mild improvement, no change, slightly worse, moderately worse, markedly worse were evaluated. Participants who withdrew from study treatment after at least 10 weeks of treatment were requested to perform the global assessments.|Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
167820|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Physical Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.||Units on a scale||Standard Deviation|Mean
167821|NCT00159874|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF28) as Assessed by the Psychosocial Scale at Year 1.|CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Year 1|ITT population included all randomized participants who took at least 1 dose of study drug in base study; certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4, 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Participants >= 5 years at baseline with questionnaire translated were included.||Units on a scale||Standard Deviation|Mean
167822|NCT00159874|Secondary|Additions From Baseline in Background Therapy up to the End of Study|This was defined as an addition or discontinuation in the class(es) of drugs used as background medication (e.g., anticoagulants, oxygen, diuretics, calcium channel blockers, and digoxin) compared to baseline of Study A1481131 (NCT00159913).|Up to the end of study|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
167823|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 4.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 4|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
167838|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 16.|Participant's cognitive development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
168799|NCT00144170|Secondary|Virologic Response at Week 24|Viral Load < 50 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
167824|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 3.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 (NCT00159913) baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 3|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
167825|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in WHO PH Functional Class by A1481156 Treatment Group at Year 2.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarised at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 2|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
167826|NCT00159874|Secondary|Summary of Shift in Changes From Start of Sildenafil in World Health Organization Pulmonary Hypertension (WHO PH) Functional Class by A1481156 Treatment Group at Year 1.|The WHO PH functional classification was as follows: Class I : Participants with PH but without resulting limitation of physical activity. Class II : Participants with PH resulting in slight limitation of physical activity. Class III : Participants with PH resulting in marked limitation of physical activity. Class IV : Participants with PH with inability to carry out any physical activity without symptoms. Changes from baseline in functional class were summarized at Years 1, 2, 3, and 4. Numbers of participants improving by 3 classes, improving by 2 classes, improving by 1 class, not changing, worsening by 1 class, worsening by 2 classes or worsening by 3 classes from A1481131 baseline at Years 1, 2, 3 and 4 were evaluated.|Baseline, Year 1|An ITT population included all randomly assigned participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline.||Participants|||Number
167827|NCT00159874|Secondary|Percentage Change From Baseline in Anaerobic Threshold at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the anaerobic threshold at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
167828|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Carbon Dioxide (CO2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal CO2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
167829|NCT00159874|Secondary|Percentage Change From Baseline in End Tidal Oxygen (O2) at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the End Tidal O2 at Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
167884|NCT00158743|Primary|Change in Creatinine Clearance|change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab|Baseline to 24-48 hours.|||milliliters/minute||Standard Deviation|Mean
168937|NCT00142818|Primary|Cocaine Use (Measured by Timeline Follow Back and Urine Screen at Week 14)||13 weeks|||number of cocaine negative urine samples||Standard Deviation|Mean
167830|NCT00159874|Secondary|Percent Change From Start of Sildenafil in Total Ventilation (VE) to Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the total ventilation. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
167831|NCT00159874|Secondary|Percent Change From Baseline in Respiratory Exchange Ratio at Year 1|This is the ratio of carbon dioxide (CO2) produced to O2 consumed [VCO2/VO2]. Exercise Tolerance Test was performed on developmentally able participants to determine the respiratory exchange ratio on week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913).|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
167832|NCT00159874|Secondary|Percent Change From Baseline in Time to Maximum VO2 at Year 1|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the time to maximum VO2. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
167833|NCT00159874|Secondary|Percentage Change From Baseline in Percent Predicted Peak VO2 at Year 1.|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to measure the percent predicted peak VO2 at Week 16 and Year 1. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant.|Baseline, Year 1|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||Percent||Standard Deviation|Mean
167834|NCT00159874|Secondary|Peak Volume of Oxygen (VO2) Consumed at Year 1 Using a Bicycle Ergometry Cardiopulmonary Exercise Test (CPX)|Exercise Tolerance Test (CPX test) was performed on developmentally able participants to determine the peak volume of VO2 consumed. Participants were assumed to be developmentally able if they had a CPX exercise assessment at any visit during study A1481131 (NCT00159913). The CPX tests were performed as close to trough plasma levels of sildenafil as possible, i.e., prior to dosing and at least 4 hours after the previous dose. If participants were able to perform the CPX test in Study A1481131 (NCT00159913), they were expected to be able to perform the exercise paradigm in the extension study (A1481156) unless their clinical condition had deteriorated and the investigator considered this was unsafe for the participant|1 year|An ITT population included all randomized participants who took at least 1 dose of study medication in base study and certain analyses were conducted at pre-specified time points: 1, 2 years and 3, 4 and 5 years (where data quantity allowed) from A1481131 (NCT00159913) baseline. Only developmentally able participants were used for this analysis.||mL/kg/min||Standard Deviation|Mean
167835|NCT00159874|Primary|Pediatric Motor Development Status at Week 52|Participant's motor development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
167836|NCT00159874|Primary|Pediatric Motor Development Status at Week 16.|Participant's motor development status was assessed at A1481156 baseline (Week 16 in A1481131; NCT00159913) using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s motor development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 16|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
167837|NCT00159874|Primary|Pediatric Cognitive Development Status at Week 52.|Participant's cognitive development status was assessed at Week 52 using the physician assessment questions. Assessment question (i.e., compared to other children the participant’s age group is this participant’s cognitive development limited?) included the following criteria : severely limited, moderately limited, mildly limited and not limited.|Week 52|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913). Participants with observed data were included in table.||Participants|||Number
167839|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Color Vision Monitoring Safety Tests.|Colour vision was measured where appropriate via the Farnsworth-Munsell D-15 Hue test. This test was performed in both eyes simultaneously or just in a single specific eye. If using a single eye the same eye was used throughout the study. In case of young participants an age-and-ability-appropriate evaluation such as the Ishihara Test for Unlettered Persons were conducted.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
167840|NCT00159874|Primary|Number of Participants With Deterioration Post Baseline in Visual Acuity Safety Tests|Visual Acuity is measured either using the reduced Snellen test or via Teller cards, and was assessed in the left and right eyes separately. There were 9 lines on the reduced Snellen chart which were coded as 6/60, 6/36, 6/24, 6/18, 6/12, 6/9, 6/6, 6/5, 6/4 (where 6/60 was the easiest to read and 6/4 was the most difficult to read). If a participant experienced a visual adverse event the investigator was asked to perform additional ocular assessments either at the visit when the participant reported the visual adverse event or at an unplanned visit.|Week 36|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
167841|NCT00159874|Primary|Downtitration in Dose Due to Intolerability.|Based on review of the survival data, DMC concluded that the high dose of sildenafil was associated with a harmful effect on survival when compared to the low dose. The DMC also expressed concern as to the potential dose-response relationship between increasing dose and mortality. Therefore, on 04 August 2011, the DMC recommended discontinuation of the 40 mg and 80 mg three times a day (TID) doses, as well as the 20 mg TID dose in children with body weight ≤20 kg. The protocol was amended per DMC recommendations.|Pre-DMC recomendation (04 August 2011)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
167842|NCT00159874|Primary|Discontinuation Due to Intolerability|Participant who experienced drug-related intolerance, the participant’s dose was reduced by 50%. If, after a dose reduction, the participant continued to appear intolerant, they were discontinued from study treatment.|Throughout the treatment duration (median treatment duration 1689 to 1744 days)|Safety population included all randomly assigned participants who took at least 1 dose of study medication in Study A1481131 (NCT00159913).||Participants|||Number
167843|NCT00159874|Primary|Number of Deaths Reported During This Study|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Last follow-up visit or 30 days after the last administration of study drug|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
167844|NCT00159874|Primary|Number of Deaths Reported in the Study Prior to the Data Monitoring Committee (DMC) Recommendation of Dose Down Titration|Deaths were reported immediately independent of the circumstances or suspected cause at any time during the study through the last follow-up visit or 30 days after the last administration of study drug, whichever comes later.|Pre-DMC Recommendation dose down titration (04 August 2011)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
167845|NCT00159874|Primary|Number of Participants Reporting Treatment-related Serious Adverse Events|All serious adverse events regardless of treatment group or suspected relationship to study drug were reported. Investigators were to provide independent determination of possible causality of any serious adverse event.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
167846|NCT00159874|Primary|Number of Participants Reporting at Least One Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the serious adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
167847|NCT00159874|Primary|Number of Participants Reporting Treatment-related Adverse Events|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
167848|NCT00159874|Primary|Number of Participants Reporting at Least One Adverse Event|Safety was measured according to standard adverse event collection as described in the adverse event section of the results. Complete tables of the adverse events according to the A1481156 treatment groups are provided in the reported adverse event section.|Up to Follow-Up visit (30 to 40 days after study completion or treatment discontinuation)|The safety population consisted of all participants who had taken at least one dose of study medication in A1481131 (NCT00159913).||Participants|||Number
167849|NCT00159861|Secondary|Change From Baseline in BORG Dyspnea Score|BORG Dyspnea score: change from core study Baseline. Subject rating of maximum degree of dyspnea experienced at any time during the 6-Minute Walk Test. Range: 0 (no breathlessness at all) to 10 (maximum breathlessness).|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.||scores on scale||Full Range|Median
167898|NCT00158223|Secondary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression-improvement (CGI-improvement) scale is a research rating tool, developed for use in NIMH-sponsored clinical trials provides a brief assessment of the clinician's view of the patient's overall clinical improvement prior to and after initiating a study medication. The CGI-change is rated on a seven point scale ranging from 1= very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment. Therefore, a lower score indicates more improvement in symptoms over time.|variable change from baseline to week 12|||units on a scale||Standard Deviation|Mean
167850|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score|Subject-rated measure of health status (36 items): 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, mental health), 2 summary scores (physical component, mental component), and a self-evaluated change in health status. Change from Baseline in SF-36 Health Transition score at each visit. I=much better than 1 year ago; II=somewhat better than 1 year ago; III=about the same as 1 year ago; IV=somewhat worse than 1 year ago; V=much worse than 1 year ago|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study. BL=Baseline.||participants|||Number
167851|NCT00159861|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those continued into the extension study.||scores on scale||95% Confidence Interval|Mean
167852|NCT00159861|Secondary|Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with evaluable data at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study.||scores on scale||95% Confidence Interval|Mean
167853|NCT00159861|Secondary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Month 15, Month 27, Month 39|FAS. N=number of subjects with evaluable data at core study Baseline; n=number of subjects with SF-36 score at observation, Placebo, Sildenafil, respectively. Treatment groups shown by core study randomization; includes subjects who who were only treated in the core study and those who continued into the extension study. Phys = physical.||scores on scale||95% Confidence Interval|Mean
167854|NCT00159861|Secondary|Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class|Pulmonary hypertension (PH) criteria: Class I: PH without limitation of physical activity (PA) (no undue dyspnea, fatigue, chest pain, near syncope); Class II: PH with slight limitation in PA, comfortable at rest, ordinary PA causes undue dyspnea, fatigue, chest pain, near syncope; Class III: PH with marked limitation in PA, comfortable at rest, less than ordinary activity causes undue dyspnea, fatigue, chest pain or syncope; Class IV: PH with inability to carry out PA without symptoms, signs of right heart failure, dyspnea or fatigue may be present at rest, discomfort increased by any PA.|1 Year, 2 Year, 3 Year|FAS; N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects in core study and in extension study. Scores for categorized changes for missing visits imputed as worse score of its non-missing neighbors; missing visits with no subsequent score: score coded to missing.||participants|||Number
167855|NCT00159861|Primary|Categorized Change From Baseline in 6-Minute Walking Distance|Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.|1 Year, 2 Year, 3 Year|FAS. m = meters. N=number of subjects with evaluable data at core study Baseline. Treatment groups shown by core study randomization; includes subjects who were only treated in the core study and those who continued into the extension study.||participants|||Number
167856|NCT00159861|Secondary|Survival Status|Yearly survival status: number of subjects who survived, discontinued, and died. Analysis includes post-treatment visit data from subjects who discontinued study treatment. Time to death was taken relative to the first dose of study treatment in A1481141, and was censored on the last day the subject was known to be alive in A1481141 or A1481153.|1, 2, 3, 4, and 5 years|Full analysis set: all randomized and treated subjects recruited into core study. N=number of subjects with evaluable data at core study Baseline.||participants|||Number
167857|NCT00159861|Other Pre-specified|Change in Epoprostenol Dose From Baseline Maintained for 6 Months|Number of subjects with changes in Epoprostenol dose from baseline maintained continuously for 6 months. Increased = Epoprostenol dose continuously more than 20% greater than core study Baseline for at least 6 months. Decrease = Epoprostenol dose continuously more than 20% less than core study Baseline for at least 6 months. No change = Epoprostenol dose change met neither Increase or Decrease criteria. Stopped = Epoprostenol dose stopped for at least 6 months.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, and at 3-month intervals through Month 69|Safety population: all subjects who took at least one dose of study medication in core study. N=number of subjects with evaluable data at core study Baseline. Includes subjects who were only treated in the core study and those who continued into the extension study.||participants|||Number
167858|NCT00159822|Secondary|Number of Subjects With Complete or Partial Serological Response|Serological response: normalization (complete response) defined as return to normal values (≤ 1 arc); partial response defined as significant decrease but not complete (decrease of 2 or more arcs compared to baseline). Complete or partial response summarized as Improvement; based on arc values at visit compared to arc values at baseline (inclusion).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT (with serology at inclusion); 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available. Data summarized as Worsening (failure), No change (stabilization), or Improvement (complete or partial response) due to large number of missing results values.||participants|||Number
167859|NCT00159822|Secondary|Number of Subjects With Mycological Response of Eradication|Mycological response: eradication: absence of aspergillus species (spp) in bronchopulmonary samples: sputum, bronchial aspirate or bronchoalveolar lavage (BAL) (negative direct examination [exam] and negative culture), and negative histological exam when available; persistence (no eradication): presence of aspergillus spp in any relevant bronchopulmonary samples. Not done (presumed eradication): case reviewed by DRC for any mycological exams not performed to assess if case should constitute presumed eradication (no sputum due to clinical improvement).|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available.||participants|||Number
167860|NCT00159822|Secondary|Number of Subjects With Complete or Partial Radiological Response|Radiological response: based on chest TDM except for tracheo-bronchialaspergillosis which was assessed by bronchoscopy. Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|Month 3, and Month 6, Month 9, or Month 12 [EOT]|mITT; End of treatment (EOT) or at last visit available [LVA](EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months).||participants|||Number
167861|NCT00159822|Secondary|Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire|Subject administered questionnaire to measure improvement in QOL; 50 questions exploring 3 different areas: symptoms, impact on activity profile (activity), and impact on daily life (impacts). Each item in an area is weighted based on empirical data; scores range from lowest possible weight 0 to highest possible weight 100. Scores for each section and total score calculated using score calculation algorithms with higher scores indicating poor health. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and EOS (EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation.||scores on scale||95% Confidence Interval|Mean
167862|NCT00159822|Secondary|Global Survival: Number of Subjects With an Outcome of Death|Number of subjects with an outcome of death (adverse event with a fatal outcome) through end of study.|Baseline through EOS (EOT + 6 months)|Safety population (SAF): all subjects who took at least 1 dose of voriconazole.||participants|||Number
167863|NCT00159822|Secondary|Time to Relapse After EOT|Time (months) to relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.||months|||Number
167864|NCT00159822|Secondary|Number of Subjects With Relapse|Relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).|During the 6 months following EOT (EOT + 3 months, EOT + 6 months)|mITT; due to the small number of radiological reappearance (4 subjects), no formal analysis of this endpoint was performed.||participants|||Number
167865|NCT00159822|Secondary|Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)|Subject assessment of improvement of respiratory clinical signs and symptoms as indicated by the subject placing a mark on a 10 cm VAS scored 0 (better state of health) to 100 (poor state of health) for cough, dyspnea, sputum, hemoptysis, chest tightness, and nocturnal awakening. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).|Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months)|mITT; 6, 9 or 12 months (in case of extension of the treatment period beyond 6 months) as EOT or last visit available; (n) = number of subjects with analyzable data at observation. Subject may be represented in >1 category.||scores on scale||95% Confidence Interval|Mean
167866|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT||paticipants|||Number
167867|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|mITT||participants|||Number
168133|NCT00153101|Secondary|ONTARGET. New Macroalbuminuria|ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <300 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial||participants|||Number
167868|NCT00159822|Secondary|Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete (resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline) or partial (reduction in diameter ≥ 50 percent on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion) radiological response and mycological eradication after 3 months of treatment and after 9 or 12 months (in case of extension of treatment period beyond 6 months); no success=criteria not met. Assessment determined by DRC.|Month 3 and End of Treatment (Month 9 or Month 12)|mITT; End of treatment (EOT) or at last visit available [LVA] (EOT or LVA includes data from 6, 9 or 12 months in case of extension of the treatment period beyond 6 months). Month 6 analysis is reported in the primary outcome measure.||participants|||Number
167869|NCT00159822|Primary|Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis|Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.|at 6 months of treatment|Modified Intent to Treat (mITT): all subjects in ITT population (took at least 1 dose of voriconazole and had at least 1 post-inclusion efficacy assessment) who had diagnosis of chronic bronchopulmonary aspergillosis confirmed by the Data Review Committee (DRC); 5 subjects excluded from mITT population due to unproven diagnosis.||participants|||Number
167870|NCT00159783|Primary|Number of Participants With Laboratory Values Outside Normal Range|"Normal ranges were provided by the central laboratory.~Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin~Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin~Endocrinology/miscellaneous = insulin, prolactin~Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils"|Week 40 or endpoint|"Number at risk = participants with either normal or abnormal baseline value and a non-missing value at endpoint.~Actual at risk: 20-32 for placebo/asenapine arm; 50-78 for asenapine arm; 63-106 in olanzapine arm."||Participants|||Number
167871|NCT00159783|Primary|Number of Participants With Markedly Abnormal Vital Sign Changes|"Vital signs measured: sitting blood pressure, heart rate.~Definitions:~Markedly abnormal decreases: heart rate (HR) – if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) – if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) – if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.~Markedly abnormal increases: HR – if ≥110 bpm and increase from baseline of ≥15 bpm; SBP – if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP – if ≥105 mm Hg and increase from baseline of ≥15 mm Hg."|Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)|||Participants|||Number
167872|NCT00159783|Primary|Abdominal Girth|Change in abdominal girth from baseline|Baseline to Week 40 or endpoint|||Centimeters (cm)||Standard Deviation|Mean
167873|NCT00159783|Primary|Concomitant Medications|"Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of~last dose of double-blind study drug."|Up to 40 weeks|||Participants|||Number
167874|NCT00159783|Primary|Extrapyramidal Symptoms [EPS]|"EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS.~AIMS score range 0-4; higher scores indicate greater symptom severity.~BARS score rang 0-9; higher scores indicate greater severity of akathisia.~SARS score range 0-40; higher scores indicate greater degree of Parkinsonism."|Week 40 or endpoint|||Units on a scale||Standard Deviation|Mean
167875|NCT00159783|Primary|Body Weight|Weight change from baseline|Baseline to Week 40 or endpoint|||Kilograms||Standard Deviation|Mean
167876|NCT00159783|Primary|Number of Participants With Abnormal Electrocardiogram|This is the number of participants with electrocardiogram (ECG) adverse events.|Week 40 or endpoint|||Participants|||Number
167877|NCT00159783|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm & rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Week 40 or endpoint|||Participants|||Number
167878|NCT00159783|Primary|Participants Who Experienced Adverse Event(s)|"Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug.~An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment.~An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect."|Up to 40 weeks|||Participants|||Number
167879|NCT00159432|Secondary|Number of Participants With Grade 3 or Higher Toxicity|Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.|Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.||Participants|||Number
167880|NCT00159432|Primary|Median Time for Progression Free Survival|Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.|Up to 6 years|All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.||Months||95% Confidence Interval|Median
167881|NCT00159419|Secondary|Bone Turnover Assessments||6 years||||||
167882|NCT00159419|Secondary|Pain Assessments||6 years||||||
167883|NCT00159419|Primary|Bone Mineral Density|By DXA|2 years|||z-score||Standard Deviation|Mean
167885|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax)|Time to maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.||hours||Standard Deviation|Mean
167886|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax)|Maximum plasma concentration observed in blood samples taken at the following time points: 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12, 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.||ng/mL||Standard Deviation|Mean
167887|NCT00158600|Primary|Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 16 hours after the end of infusion. Blood sample time points were 0 (before the start of the infusion), 1 and 2 hours after the start of infusion, end of the infusion, and then 0.25, 0.5, 1, 2, 3, 4, 8, 12,and 16 hours after the end of the infusion (with a 5-minute window for time-points after the start of infusion). Pooled figures combine the values for the three timeframes.|weeks 0, 12 and 52|The subgroup of patients for whom pharmacokinetic samples were obtained was based on those study sites that could accommodate pharmacokinetic sampling needs.||ug*h/mL||Standard Deviation|Mean
167888|NCT00158600|Secondary|Health-related Quality of Life Survey Values Related to Physical Components as Measured by the Medical Outcomes Study (MOS) Short Form-36 Health Survey|The Medical Outcomes Study Short Form (MOS SF)-36 questionnaire consists of 36 items grouped into 8 domains designed to assess generic health-related quality of life in healthy and ill adult populations. Physical Component Scores (PCS) report the four domains of physical functioning, role-physical, bodily pain, and general health. Higher scores are associated with better quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The PCS scores are reported.|weeks 0, 78|ITT population. Last observation carried forward.||Units on a scale||Standard Deviation|Mean
167889|NCT00158600|Secondary|Percent Predicted Proximal Muscle Strength of the Lower Limbs as Measured by Quantitative Muscle Testing (QMT)|Quantitative muscle testing (QMT) is a standardized system to measure muscle force production during maximal voluntary isometric contraction. QMT data were collected directly from sensors into laptop computers. Predicted normal values for QMT are based on a formula using sex, age and body mass index of a person, and is an estimate of healthy muscle force. Percent of predicted QMT = (observed value)/(predicted value) * 100%. The QMT Leg Score is the average of the bilateral means for percent predicted knee flexors and extensors. A value of 100% indicates 'normal' muscle strength.|weeks 0, 78|ITT population. Last observation carried forward.||percent predicted QMT||Standard Deviation|Mean
167890|NCT00158600|Primary|Percent of Predicted Forced Vital Capacity (FVC)|Forced vital capacity is a standard pulmonary function test used to quantify respiratory muscle weakness. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|weeks 0, 78|ITT population. Last observation carried forward.||percent predicted FVC||Standard Deviation|Mean
167891|NCT00158600|Primary|Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline|Mean distance walked gives an indication of functional endurance. The greater the distance, the greater the endurance. Mean values of distance walked in a six-minute walk test are offered for baseline, week 78 (or last available observation), and the mean change from baseline (at week 78 or last available post-baseline observation).|weeks 0, 78|Intent-to-Treat (ITT) population. Last observation carried forward. The last available distance walked for one patient was the Baseline visit; therefore, this patient was excluded from the change from baseline calculation.||meters||Standard Deviation|Mean
167892|NCT00158600|Primary|Summary of Patients Reporting Treatment-Emergent Adverse Events|Overall safety summary of patients experiencing Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, and Infusion Associated Reactions (IARs). Summary is based on Treatment-emergent AEs (TEAEs), defined as AEs that occurred following the initiation of study treatment, i.e., alglucosidase alfa or placebo.|weeks 0-78|"All patients who received any amount of study treatment comprise the safety population. Patients were considered, for safety analysis, to be in the treatment group of the treatment they actually received.~Missing or invalid safety or resource utilization data were not replaced."||participants|||Number
167893|NCT00158379|Secondary|Toxicity|defined as hematological and non-hematological adverse events of grade >= grade 1|after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years|||participants|||Number
167894|NCT00158379|Primary|Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%|Time to progression|every 3 months for up to 3 years|||months||95% Confidence Interval|Median
167895|NCT00158249|Secondary|Neurocognitive Function|Multiple Source Interference Test (MSIT)|Before and after 8 weeks of treatment|||Accuracy percent improvement||Standard Error|Mean
167896|NCT00158249|Primary|Marijuana Use||Measured for 8 weeks of treatment|||Reported uses per day||Standard Error|Mean
167897|NCT00158223|Primary|Negative Syndrome Scale (PANSS) Total Score|Severity of negative schizophrenic symptoms, The Negative Syndrome scale is compromised of seven items, each scored on severity with numeric assignments ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The items which comprise the Negative Syndrome Scale of the PANSS measure things such as emotional withdrawal, apathy, difficulty in abstract thinking, etc. The seven items which comprise the PANSS Negative Subscale has an aggregate range of 7 (absent) to 49 (extreme psychopathology), a higher score indicating more severe symptoms.|Variable change from baseline to week 12|||units on a scale||Standard Deviation|Mean
167899|NCT00158223|Primary|Positive Syndrome Scale (PANSS) Total Score|Severity of positive schizophrenic symptoms The Positive Syndrome Scale of the PANSS is comprised of seven items measuring positive such symptoms such as hallucinations, delusions, grandiosity, etc. Each item is scored on a 7 point scale of that particular symptom's severity, ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The PANSS Positive Subscale seven items has a range of a summed score from 7 (absent) to 49 (extreme psychopathology). Therefore, the higher the score, the more severe the symtpoms.|Variable change from baseline to week 12|||units on a scale||Standard Deviation|Mean
167900|NCT00158197|Primary|Methamphetamine Use, Follow-Up|Drug use measured by urine toxicology conducted by on site EMIT assay over time|1x/month for 4 months|||percentage of negative urine samples|Participants||Number
167901|NCT00158197|Primary|Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence|Drug use measured by urine toxicology conducted by on site EMIT assay and added up to obtain how many days of consecutive abstinence were observed for each individual|16 Weeks|||days||Standard Deviation|Mean
167902|NCT00158197|Primary|Methamphetamine Use During Intervention|Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.|3x/week for 16 weeks|All individuals randomized were included in the analysis (i.e., intention to treat).||percentage of negative urine samples|Participants||Number
167903|NCT00158054|Secondary|All-cause Mortality|All- cause mortality|18 months|||participants|||Number
167904|NCT00158054|Secondary|Number of Participants Experiencing Major Adverse Cardiovascular Events|The table represents the number of participants experiencing major adverse cardiovascular events|6 months|||participants|||Number
167905|NCT00158054|Secondary|Level of Depressive Symptoms|Depressive symptoms were measured using the Beck Depression Inventory (BDI), which is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst symptoms).|6 months|||units on a scale||95% Confidence Interval|Mean
167906|NCT00158054|Primary|Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms.|Number of participants who rated their depression care as excellent or very good as a percentage.|6 months|||percentage of participants|||Number
167907|NCT00157950|Secondary|Number of Participants With Adverse Experiences|Number of participants who reported 1 or more adverse experience.|Overall study including 14 calendar days after the last vaccination visit.|All participants who received at least 1 dose of injection.||Participants|||Number
167908|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 18.|Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
167909|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 16.|Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
167910|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 11.|Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
167911|NCT00157950|Primary|Number of Participants Who Seroconvert to HPV 6.|Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.||Participants|||Number
167912|NCT00157820|Secondary|Number of Each of the Components of the CSAE|"The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.~Number of each of the components of CSAE, counts the number of events for each pre-determined level."|17 months|||events|||Number
167913|NCT00157820|Primary|CSAE-score Rate(Clinical Significant Adverse Events Score Rate)|Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate.|17 months|ITT||score/month|Participants||Number
167914|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (4 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 4-hour GET is calculated as % of gastric retention at 4 hours at baseline - % of gastric retention at 4 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percent retention||Inter-Quartile Range|Median
168800|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<50 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
167915|NCT00157755|Other Pre-specified|Change in Gastric Emptying Results at 12 Months Compared to Baseline (2 Hours)|Gastric emptying was evaluated using a standardized scintigraphy method and a low fat egg substitute test meal. After standard meal and marker preparation, the subsequent images were taken at 2 hours and 4 hours and percentage of gastric retention was evaluated. Change in 2-hour GET is calculated as % of gastric retention at 2 hours at baseline - % of gastric retention at 2 hours at 12 months. A positive change represents an improvement in gastric emptying at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percent retention||Inter-Quartile Range|Median
167916|NCT00157755|Other Pre-specified|Change in Quality of Life at 12 Months Compared to Baseline (Mental Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The mental component summary (MCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on mental health. The change in MCS is calculated as MCS at baseline - MCS at 12 months. A negative change in MCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.||Scores on a scale||Standard Deviation|Mean
167917|NCT00157755|Other Pre-specified|Change in Quality of Life (QOL) at 12 Months Compared to Baseline (Physical Component Summary)|The QOL scores were collected using the SF-36 questionnaire, which included the scores in the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The physical component summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health. The change in PCS is calculated as PCS at baseline - PCS at 12 months. A negative change in PCS represents an improvement in QOL.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.||Scores on a scale||Standard Deviation|Mean
167918|NCT00157755|Other Pre-specified|Change in Symptom Score at 12 Months Compared to Baseline.|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The change is calculated as TSS at baseline - TSS at 12 months. A positive change represents an improvement in TSS at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized and completed the study at 12 months.||Scores on a scale||Standard Deviation|Mean
167919|NCT00157755|Other Pre-specified|Percentage of Responders at 12 Months|Responders were defined as having a 50% or greater reduction of WVF from baseline to 12 months. The percentage of responders was estimated as the proportion of the responders among all subjects who finished the 12-month visit. The percentage of responders was tested to determine if it was statistically greater than 50%.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percentage of responders|||Number
167920|NCT00157755|Secondary|Percent Reduction in the Frequency of Weekly Vomiting Episodes at 12 Months Compared to Baseline|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF at baseline - WVF at 12 months)/ (WVF at baseline))*100%. A positive reduction represents an improvement in WVF at 12 months.|baseline and 12 months|The analysis population included subjects who were randomized, completed the study at 12 months and provided evaluable measurements.||Percent reduction in WVF||Full Range|Median
167921|NCT00157755|Secondary|Percent Reduction in Symptom Score When the Device is Turned ON, Relative to When the Device is Turned OFF|A symptom interview was conducted at each visit to assess vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain and epigastric burning. The scale for each symptom ranges from 0 to 4, with 0 being absence of symptoms and 4 being extremely frequent (≥ 7 episodes per week). Total symptom score (TSS) is the sum of the individual frequency symptom scores. The percent reduction is calculated as ((TSS during OFF - TSS during ON)/ (TSS during OFF))*100%. A positive reduction represents an improvement in TSS when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.||Percent reduction in symptom score||Full Range|Median
167922|NCT00157755|Primary|Percent Reduction in Frequency of Weekly Vomiting Episodes When the Device is Turned ON, Relative to When the Device is Turned OFF|Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))*100%. A positive reduction represents an improvement in WVF when the device was ON.|4.5 months and 7.5 months|The analysis population included subjects who were randomized, completed the study through the end of the blinded crossover period and provided evaluable measurements.||percent reduction in WVF||Full Range|Median
167923|NCT00157248|Secondary|Laboratory Analyses|"Frequency of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Alanine aminotransferase (ALT): 5-45 [U/L]~Aspartate aminotransferase (AST): 10-40 [U/L]~Bilirubin, total: 0.2-1.0 [mg/dL]"|5 years|All treated patients.||participants|||Number
167934|NCT00157248|Secondary|Yearly Event Rate for Transient Ischaemic Attacks|Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
168801|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<50 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
167924|NCT00157248|Primary|Yearly Event Rate for Minor Bleeding|"Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds.~Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed >5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding >5 min, leading to hospitalization, leading to a transfusion of <2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167925|NCT00157248|Secondary|Severe Adverse Event|Frequency of patients with severe adverse events.|5 years|All treated patients.||participants|||Number
167926|NCT00157248|Secondary|Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality|"Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167927|NCT00157248|Primary|Yearly Event Rate for Any Bleeding|Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167928|NCT00157248|Primary|Yearly Event Rate for Major + Minor/Relevant Bleeding|Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167929|NCT00157248|Primary|Yearly Event Rate for Major Bleeding|"Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167930|NCT00157248|Secondary|Yearly Event Rate of Death|Time to death of any cause. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167931|NCT00157248|Secondary|Yearly Event Rate of Other Major Adverse Cardiac Events|Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167932|NCT00157248|Secondary|Yearly Event Rate of Myocardial Infarction|Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167933|NCT00157248|Secondary|Yearly Event Rate for Systemic Thromboembolism|"Time to first occurrence of any non-central nervous system systemic thromboembolism.~Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25"|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167935|NCT00157248|Secondary|Yearly Event Rate of Haemorrhagic Stroke|Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167936|NCT00157248|Secondary|Yearly Event Rate of Ischaemic Stroke|Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167937|NCT00157248|Secondary|Yearly Event Rate for Stroke|Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167938|NCT00157248|Primary|Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.|Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25|5 years|All treated patients. In this non-randomized follow-up study, most patients changed treatment regimens per amendment during conduct and treatment exposure was not comparable between regimens. Events were assigned to the regimen a patient received prior to the event, and patients may be counted in multiple regimens. No statistical analysis was done.||yearly event rate (percentage)|||Number
167939|NCT00157209|Secondary|Number of Participants With Elevated CA27-29 Antigen Levels|CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.|Study entry, Week 8|"Analysis population included all randomized participants. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."||participants|||Number
167940|NCT00157209|Secondary|Number of Participants With Positive T-cell Proliferation|T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.|Time from randomization until cut-off date (15 March 2006)|"Analysis population included all randomized participants. N signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment."||participants|||Number
167941|NCT00157209|Secondary|Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score|Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items. Each item uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL.|At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.|"Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively."||Units on a scale||Standard Deviation|Mean
167942|NCT00157209|Primary|Overall Survival Time|Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)|Analysis population included all randomized participants.||months||95% Confidence Interval|Median
167943|NCT00157209|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.|From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)|Analysis population included all participants randomized in the study.||participants|||Number
168131|NCT00153101|Secondary|ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial||participants|||Number
167944|NCT00157196|Secondary|Progression Free Survival (PFS) Time|PFS was defined as duration from first administration of trial treatment until progressive disease [PD] (radiological or clinical, if radiological progression is not available) or death due to any cause. Participants without event were censored on the date of last tumor assessment. Clinical assessments were performed 4 weekly in primary treatment and 6 weekly in maintenance treatment.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.||months||95% Confidence Interval|Median
167945|NCT00157196|Secondary|Survival Time|Survival time was to be measured from study entry (date of cyclophosphamide administration) to date of death. For subjects alive or lost to follow-up at time of analysis, the time between date of cyclophosphamide administration and date on which the subject was last known alive was to be calculated and used as a censored observation in the analysis.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.||months||95% Confidence Interval|Median
167946|NCT00157196|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.|Up to data cut-off date (17 September 2007)|Safety analysis set included all the enrolled participants who received at least one dose of the trial treatment.||participants|||Number
167947|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Number of Participants With Intensive Treatment and High Dose (≤20 Exposure Days (EDs))|Immunogenicity Analysis Set- Participants with 5 consecutive study days of a mean infusion dose of FVIII >50 IU/kg within ≤20 EDs who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM||Participants|||Number
167948|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Race|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM||Participants|||Number
167949|NCT00157157|Post-Hoc|Factor VIII Inhibitor Risk Factor: Genetic Risk Factor- Family History of Inhibitors|Number of treated participants who developed an inhibitor|Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)|Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM||Participants|||Number
167950|NCT00157157|Secondary|Development of Antibodies to Heterologous Proteins|Percentage of treated participants who developed antibodies to heterologous proteins (ie, Chinese Hamster Ovary Cell Protein, Murine IgG, or Recombinant Human VWF)|Assessed at baseline, throughout the duration of the study, which was to be at least 75 exposure days or 3 years (whichever came first), and at the termination visit.|Participants who received at least 1 infusion of rAHF-PFM and had assessments of heterologous antibodies||Percentage of Participants|||Number
167951|NCT00157157|Secondary|Adverse Events Deemed Related to Treatment|Percentage of participants who reported AEs deemed related to treatment with rAHF-PFM|Reported during the study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM||Percentage of Participants|||Number
167952|NCT00157157|Secondary|Assessment of Blood Loss During Surgical Procedures|Percentage of actual intraoperative blood loss compared to preoperatively predicted average and maximal blood loss in hemostatically normal matched individuals (from institutional blood bank records)|Predicted volumes preoperatively estimated and actual volumes intraoperatively recorded|Number of participants who underwent a surgical procedure with blood loss assessments||Percentage Blood Loss||Full Range|Median
167953|NCT00157157|Secondary|Assessment of Postoperative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with investigator's assessment of hemostasis based on a 4-point ordinal scale:~Excellent: hemostasis was as good as or better than other licensed factor VIII products for matched procedure~Good: hemostasis was probably as good as other licensed factor VIII products for matched procedure~Fair: hemostasis was clearly < optimal for matched procedure, without need to change regimen~None: bleeding from inadequate response with proper dosing, necessitating a change in regimen"|Assessed at the time of discharge from hospital or clinic|Number of participants who underwent a surgical procedure with a postoperative assessment of hemostatic efficacy||Procedures|||Number
167954|NCT00157157|Secondary|Assessment of Intra-operative Hemostasis|"Number of surgical procedures managed with rAHF-PFM and with surgeon's assessment of hemostasis based on a 4-point ordinal scale:~Excellent: ≤ average predicted blood loss for matched procedures in healthy individuals~Good: > average predicted blood loss, but ≤ maximal predicted blood loss for matched procedures in healthy individuals~Fair: > maximal predicted blood loss for matched procedures in healthy individuals, and hemostasis was achieved~None: uncontrolled hemostasis with proper dosing, necessitating a change in treatment regimen"|Assessed at the time of discharge from recovery room|Number of participants who underwent a surgical procedure with an intraoperative assessment of hemostatic efficacy||Procedures|||Number
167955|NCT00157157|Secondary|In Vivo Incremental Recovery|Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.|30 minutes pre-infusion to 30 minutes post-infusion|Participants who received pharmacokinetic rAHF-PFM infusions, did not develop inhibitors, and had assessments||IU/dL per IU/kg||Full Range|Median
167967|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria (Pediatric Population)|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one rejection episode."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
167956|NCT00157157|Secondary|Weekly rAHF-PFM Utilization|"Weight-Adjusted Weekly Dose for Prophylaxis, On-Demand Treatment, and Perioperative Management.~rAHF-PFM dose determined by the investigator (ie: standard regimen [25-50 IU/kg body weight, 3-4 times per week]; modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). Dosing to treat BEs was at investigator's discretion and in accordance with institution’s standard of care.~rAHF-PFM was administered I.V. via bolus infusion, except for perioperative management when it was given either by continuous or bolus infusion."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period||IU/kg||Full Range|Median
167957|NCT00157157|Secondary|Annualized Rate of Bleeding Episodes|Number of bleeding episodes per subject annualized over 1 year for all etiologies|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period||bleeding episodes per subject per year||Full Range|Median
167958|NCT00157157|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes|"Number of rAHF-PFM-treated bleeding episodes with treater assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within ~8 hrs after infusion. Requires >1 infusion for complete resolution; or~None: No improvement or condition worsens."|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|"Participants who received at least 1 infusion of rAHF-PFM and had at least 1 treated bleeding episode. The 1 rating of none was for the first 2 infusions, the last infusion was rated as good."||bleeding episodes|||Number
167959|NCT00157157|Secondary|Bleeding Episodes Treated With 1 to ≥4 Infusions|The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis|Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM for the treatment of bleeding episodes||Bleeding episodes|||Number
167960|NCT00157157|Primary|Factor VIII Inhibitor Development|Percentage of treated participants who developed factor VIII inhibitors|Assessed during study period which was to be at least 75 exposure days or 3 years (whichever came first)|Participants who received at least 1 infusion of rAHF-PFM||percentage||95% Confidence Interval|Number
167961|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure (Pediatric Population)|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
167962|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52 (Pediatric Population)|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
167963|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient (Pediatric Population)|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||MCAR per patient||Standard Deviation|Mean
167964|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment (Pediatric Population)|A summary of rejection episodes requiring treatment regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
167965|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection (Pediatric Population)|Severe Acute Rejection was defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
167966|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant (Pediatric Population)|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.||Days||Standard Deviation|Mean
167968|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Cystatin-C (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||mg/L||Standard Deviation|Mean
167969|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: hsCRP (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||mg/L||Standard Deviation|Mean
167970|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: Nitrotyrosine (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population - defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||nM||Standard Deviation|Mean
167971|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation and Oxidation: F2 Isoprostanes (Pediatric Population)|Change is defined as Week 52 assessment - Pre-Transplant assessment|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||pg/mL||Standard Deviation|Mean
167972|NCT00157014|Secondary|Number of Patients With Treatment Failure and Crossover for Treatment Failure|"Treatment failure was defined as death, re-transplantation, withdrawal due to an Adverse Event, or a switch of main immunosuppressant medication, whichever came first.~Crossover was defined as a switch from originally administered primary immunosuppressant (tacrolimus or cyclosporine) to the alternate primary immunosuppressant."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
167973|NCT00157014|Secondary|Number of Patients With Successful Steroid Taper or Withdrawal at Weeks 26 and 52|A successful steroid taper or withdrawal was defined as steroids (prednisone) being discontinued or tapered to the suggested dose level after week 26.|26 Weeks and 52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
167974|NCT00157014|Secondary|Mean Cases of Acute Rejection (MCAR) Per Patient|"MCAR represents the average number of acute rejections among all patients in each treatment group. Results were based on rejection episodes with endomyocardial biopsies.~Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||MCAR per patient||Standard Deviation|Mean
167975|NCT00157014|Secondary|Number of Cardiac Rejection Episodes Requiring Treatment|The number of rejection episodes requiring treatment (medications started/ stopped, non-medication treatment, or both) regardless of biopsy grade or presence of hemodynamic compromise.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
167976|NCT00157014|Secondary|Number of Patients Requiring Antilymphocyte Antibodies or Steroids for Treatment of Severe Acute Rejection|Severe Acute Rejection is defined as rejection with ISHLT Grade 4.|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Patients|||Number
167977|NCT00157014|Secondary|Time to First Acute Rejection Episode Following de Novo Cardiac Transplant|"Acute Rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Time to first acute rejection is defined as: date of onset - date of transplant."|52 Weeks|The population analyzed represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. Only participants who experienced acute rejection were included in the analysis.||Days||Standard Deviation|Mean
167978|NCT00157014|Secondary|Number of Acute Rejection Episodes by International Society of Heart and Lung Transplantation (ISHLT) Criteria|"Acute rejection was defined as a rejection with ISHLT Grade ≥3A or by the presence of hemodynamic compromise.~ISHLT Grades ≥3A include: Multifocal Moderate Rejection; Diffuse, Borderline Severe Acute Rejection; and Severe Acute Rejection.~Patients may report more than one acute rejection."|52 Weeks|The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation.||Rejection Episodes|||Number
167979|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Cystatin-C|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||mg/L||Standard Deviation|Mean
167980|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-18|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||pg/mL||Standard Deviation|Mean
167981|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: IL-6|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~IL= Interleukin"|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||pg/mL||Standard Deviation|Mean
167982|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Fibrinogen|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||g/L||Standard Deviation|Mean
167983|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Osteopontin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||ng/mL||Standard Deviation|Mean
167984|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Troponin T|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||ug/L||Standard Deviation|Mean
167985|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: BNP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~BNP= Brain Natriuretic Peptide"|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||ng/L||Standard Deviation|Mean
167986|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: GSH/GSSG|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~GSH/GSSG= ratio of reduced to oxidised glutathione"|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||Ratio||Standard Deviation|Mean
167987|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Nitrotyrosine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||nM||Standard Deviation|Mean
167988|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: T-bars|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~T-bars = thiobarbituric acid reactive substances"|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||nmol/mL||Standard Deviation|Mean
167989|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: F2 Isoprostanes|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||pg/mL||Standard Deviation|Mean
167990|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: hsCRP|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~hsCRP= high-sensitivity C Reactive Protein"|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||mg/L||Standard Deviation|Mean
167991|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: Homocysteine|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||μmol/L||Standard Deviation|Mean
167992|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: E-selectin|Change is defined as Week 52 assessment - Pre-Transplant assessment.|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||ng/mL||Standard Deviation|Mean
167993|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: s-ICAM|"Change is defined as Week 52 assessment - Pre-Transplant assessment.~s-ICAM= soluble-intracellular adhesion molecule"|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||ng/mL||Standard Deviation|Mean
167994|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies (Pediatric Population)|"The markers assessed were p-ERK ½, p-JNK and p-p38 MAPK.~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each marker is noted in the category titles, as N."||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
167995|NCT00157014|Secondary|Changes in Circulating Markers of Inflammation, Oxidation, Growth, Apoptosis, Differentiation and Survival: MCP-1|"Change is defined as Week 52 assessment – Pre-Transplant assessment.~MCP-1= monocyte chemoattractant protein-1"|Pre-Transplant and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each row is noted in the category titles, as N."||pg/mL||Standard Deviation|Mean
167996|NCT00157014|Primary|The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies|"The markers assessed were p-ERK ½ (phosphorylated extracellular signal-regulated kinase), p-JNK (phosphorylated jun N-terminal kinase) and p-p38 MAPK (phosphorylated mitogen-activated protein kinase).~The data for each biopsy marker were expressed as a ratio of its densitometry / densitometry of glyceraldehyde-3-phosphate dehydrogenase (GAPDH).~Change is defined as Week 52 assessment- Week 2 assessment."|2 Weeks and 52 Weeks|"The number of participants analyzed per arm represents Treatment Exposure Population- defined as all patients receiving at least 1 dose of study medication summarized according to treatment received regardless of randomization allocation. The number of participants included in the calculation for each marker is noted in the category titles, as N."||Densitometry / Densitometry of GAPDH||Standard Deviation|Mean
167997|NCT00156936|Primary|Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 3 years|Safety population includes all enrolled subjects who received at least 1 dose of study drug (VIVITROL 380 mg) in this extension study.||Participants|||Number
167998|NCT00156923|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).|Up to 3.5 years of monthly treatment|Subjects who received at least 1 injection of study drug were included in the safety analyses||Participants|||Number
167999|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Episodes|Mean change from baseline in frequency (number) of migraine/probable migraine headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours and met ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat||Migraine/Prob Migraine Headache Episodes||Standard Deviation|Mean
168000|NCT00156910|Secondary|Change in Frequency of Migraine/Probable Migraine Headache Days|Mean change from baseline in frequency (number) of migraine/probable migraine headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day with >= 4 continuous hours of headache meeting ICHD-II criteria for migraine or probable migraine.|Baseline, Week 24|Intent to Treat||Migraine/Probable Migraine Headache Days||Standard Deviation|Mean
168001|NCT00156910|Secondary|Change in Frequency of Acute Headache Pain Medication Intakes|Mean change from baseline in frequency (number) of acute headache pain medication intakes during the 28 day period ending with Week 24. Medication intakes defined as the number of times a patient took acute headache pain medication regardless of dose or type/number of medications taken at the same time.|Baseline, Week 24|Intent to Treat||Medication Intakes||Standard Deviation|Mean
168002|NCT00156910|Secondary|Change in Frequency of Headache Days|Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day [00:00 to 23:59] for which the patient reported >= 4 continuous hours of headache|Baseline, Week 24|Intent to Treat||Headache Days||Standard Deviation|Mean
168003|NCT00156910|Primary|Change in Frequency of Headache Episodes|Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted >= 4 continuous hours.|Baseline, Week 24|Intent to Treat||Headache Episodes||Standard Deviation|Mean
168004|NCT00156819|Primary|Treatment Failure|The primary outcome measure was treatment failure, defined as the occurrence of any one of the following events: hospitalization or an urgent medical visit for asthma initiated by the patient or physician; use of systemic corticosteroids for asthma or need for open-label use of inhaled corticosteroids for asthma, as determined by the study physician or an asthma care provider; a decrease in prebronchodilator forced expiratory volume in 1 second (FEV1) to more than 20% below the baseline value measured at randomization; a decrease in the morning peak expiratory flow rate to more than 35% below the baseline value (the mean over the final 2 weeks of the run-in period) on 2 consecutive days; use of 10 puffs or more per day of rescue beta-agonist for 2 consecutive days (except as medication before exercise); refusal of the patient to continue because of lack of satisfaction with treatment; or judgment by a physician that the patient should stop treatment for reasons of safety.|16 weeks|||participants|||Number
168005|NCT00156715|Secondary|Clinical Symptoms|The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in this analysis. Participants from Site 2 were all admitted to the study directly from the hospital, which could have affected their behavior.||Units on a scale||Standard Deviation|Mean
168006|NCT00156715|Primary|Mean Number of Drinking Days Per Week|Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.|12 Weeks|Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in the analysis. Participants from Site 2 were all admitted to the study directly from the hospital which could have affected their alcohol consumption.||Drinking Days per Week||Standard Deviation|Mean
168007|NCT00156533|Secondary|Wake After Sleep Onset (WASO)|Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-Treatment (12 weeks)|Completers||participants|||Number
168008|NCT00156533|Primary|Sleep Latency (SL)|Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.|Baseline and Post-treatment (12wks)|Completers Only||participants|||Number
168009|NCT00156390|Secondary|Echocardiographic Improvement||1 year||||||
168010|NCT00156390|Primary|Minnesota For Living With Heart Failure Questionnaire|"Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = no heart failure did not prevent one from living as they want and 5= yesheart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life."|1 year|||units on a scale||Standard Deviation|Mean
168011|NCT00156247|Secondary|Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving a clear (0) or almost clear (1) status on the Physician Global Assessment (PGA) at 6 months. This index evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|6 months|||percent|||Number
168012|NCT00156247|Secondary|Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months|||percent|||Number
168013|NCT00156247|Primary|Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at 6 months. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|6 months|||percent|||Number
168014|NCT00156065|Primary|Median Survival Time of Effect|"Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension.~PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.~Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|52 Weeks|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.||Days||95% Confidence Interval|Median
168015|NCT00156065|Primary|Loss of Effect Over Time|"Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension.~PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.~Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy."|Throughout the 52 weeks of the trial.|These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score >= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.||Participants|||Number
168016|NCT00156013|Secondary|Toxicity||5 years||||||
168017|NCT00156013|Secondary|Time to Treatment Failure||5 years||||||
168018|NCT00156013|Primary|Phase II Overall Response||5 years||||||
168019|NCT00156013|Primary|Phase I Maximum Tolerated Dose|Maximum Tolerated Dose for Clofarabine. Cohorts of 3 patients each will receive doses of clofarabine increased in increments as follows: 4, 6, 8, 10, 12,…etc mg/m2/day for 5 days. The dose level immediately below the MTD will be used to treat patients in the Phase II part of the study. Starting dose of 4 mg/m2.|days 1 -28, maximum 6 cycles|Per protocol guidelines for accrual to the cohorts.||mg/m^2|||Number
168020|NCT00153920|Secondary|Any Grade Neuropathic Pain Events|Any grade neuropathic pain events based on CTCAEv2 as reported on case report forms.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||adverse events|||Number
168022|NCT00153920|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing soft tissue plasmacytomas and/or lytic lesions or new; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months as of the data analysis.|The analysis population is comprised of eligible and treated participants.||months||95% Confidence Interval|Median
168023|NCT00153920|Secondary|Time to Progression (TTP)|TTP based on the Kaplan-Meier method is defined as the time from start of treatment to documentation of disease progression (PD). Participants without evidence of PD were censored at the latest date of last disease assessment or date of initiation of non-protocol therapy. PD was established based European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). PD required 1 or more of the following: >25% increase in serum monoclonal protein with absolute minimum of 0.5 g/dL (confirmed on repeat investigation); >25% increase in 24-hour urinary light chain excretion with minimum absolute increase of 200 mg/24 hrs (confirmed on repeat investigation); >25% increase in bone marrow plasma cells with minimum absolute increase of 10%; Definite increase in size of existing or new soft tissue plasmacytomas and/or lytic lesions; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL not attributable to other cause).|Disease was assessed every two cycles on treatment and every 6 weeks in long-term follow-up. Median follow-up was 29 months.|The analysis population is comprised of eligible and treated participants.||months||95% Confidence Interval|Median
168024|NCT00153920|Secondary|Very Good Partial Response (VGPR) Rate|Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; >=90% reduction in serum M-component plus urine M-component <100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a >90% decrease in the difference between involved and uninvolved FLC levels.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||proportion of participants||95% Confidence Interval|Number
168025|NCT00153920|Primary|Objective Response (OR) Rate|Objective response was defined as complete response (CR) or partial response (PR) according to European Group for Blood and Marrow Transplantation criteria (Blade J et al Br J Haematol 1998). CR required all of the following: Negative immunofixation on the serum and urine at two consecutive times for minimum 6 weeks; Disappearance of soft tissue plasmacytomas for at least 6 weeks; <5% plasma cells in bone marrow on 2 determinations for a minimum of 6 weeks; No increase in the size or number of lytic bone lesions. PR required all the following: ≥50% reduction in the level of the serum monoclonal protein on 2 determinations for minimum 6 weeks; If present, reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg on 2 determinations for minimum 6 weeks; ≥50% reduction size of soft tissue plasmacytomas for minimum 6 weeks; No increase in the number or size of lytic bone lesions. Development of a compression fracture does not exclude response in either category.|Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).|The analysis population is comprised of eligible and treated participants.||proportion of participants||95% Confidence Interval|Number
168026|NCT00153816|Secondary|Advanced Colorectal Lesions|Includes: adenomas >=1 cm, adenomas with high grade dysplasia, adenomas with villous features, or cancer.|1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and sufficient histology available to ascertain the endpoint.||percentage of subjects||95% Confidence Interval|Number
168027|NCT00153816|Primary|Colorectal Adenomas||1 to 10 years|Subjects are included if they had a follow-up exam at least one year after randomization and had sufficient histology available to ascertain the endpoint.||percentage of subjects||95% Confidence Interval|Number
168028|NCT00154466|Secondary|Angiogenic Cytokines at Baseline and 3-month Follow-up|Angiogenic cytokines such as vascular endothelial growth factor (VEGF), stromal-derived factor-1 (SDF-1) and stem cell factor (SCF) are known to increase the formation of new vessels at ischaemic sites and thus enhance myocardial perfusion. To rule out any effect of short-term exercise on cytokines levels, blood samples were always taken after at least 72 h of physical inactivity and overnight fasting when the subject had rested in the sitting position for at least 10 min. The plasma samples were immediately frozen and stored at −70°C. High-sensitivity ELISA (Bender MedSystems, R&D) were used to measure plasma levels of SCF, SDF-1 and VEGF according to the manufacturer’s protocols.|3 months|We calculated that we would need 18 patients in each group to achieve a power of at least 80% to detect a 20% difference in MBF change between study groups, with a two-sided significance level of p<0.05, and a 20% increase for the stress MBF change from baseline to 3 months' follow-up. The analysis was intention-to-treat.||pg/ml||Standard Deviation|Mean
168029|NCT00154466|Primary|Myocardial Blood Flow at Baseline and 3-month Follow-up|First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.|3 months|Eligible patients were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. Healthy controls underwent the test of myocardial perfusion only at baseline. The analysis was intention-to-treat.||ml/min/g||Standard Deviation|Mean
168030|NCT00154375|Secondary|Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations|National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each AE term. Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|6 months - 1 year|The safety population consisted of randomized patients with at least one dose of randomized medication.||Participants|||Number
168031|NCT00154375|Primary|Percentage of Participants With Progression Free Survival (PFS) During the Study Duration|PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).|6 months -1 year|The ITT population consists of all randomized patients, analyzed according to their randomized treatment.||Percentage of Participants||95% Confidence Interval|Number
168032|NCT00154310|Secondary|Number of Participants Who Experienced an Adverse Event or Serious Adverse Event|Additional information about the number of participants who experienced Adverse Events (greater than 5%) or Serious Adverse Events can be found in the Adverse Event section.|Aes from end of core study period (month 12) to end of follow-up period (month 60)|Safety Population consisted of all participants in whom transplantation was performed and who were treated with at least one dose of any immunosuppressive medication.||Participants|||Number
168033|NCT00154310|Secondary|Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12|An updated 1991 Framingham coronary prediction algorithm was used to estimate the total risk of developing coronary heart diseases (CHD) over the course of 10 years. Risk was calculated separately for male and females. To calculate risk, points were assigned for each of the following risk factors: age, levels of LDL cholesterol, HDL cholesterol, blood pressure, cigarette smoking, and diabetes mellitus. The sum of the individual risk factor points gives a total point score, which ranges from -5 to 18 for men and -16 to 24 for women. Higher points indicate a higher risk for CHD.|Month 4.5 and Month 12|Safety Population for whom data was available at Month 4.5 and end of treatment.||Points||Standard Deviation|Mean
168034|NCT00154310|Secondary|Number of Participants With Occurrence of Treatment Failures|Treatment failures defined as a composite endpoint of biopsy proven acute rejection, graft loss, death, loss to follow up and discontinuations due to lack of efficacy or toxicity, or conversion to another regimen (at least one condition must be present).|up to or at Month 12|Intention to treat (ITT) population (Randomized Patients).||Participants|||Number
168035|NCT00154310|Secondary|Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death|The number of participants with occurrence of biopsy proven acute rejection (BPAR), graft loss, or death up to Month 12 during the randomized treatment period. BPAR was defined as a biopsy graded IA, IB, IIA, IIB or III according to Banff 97 classification. A graft core biopsy was performed prior to 24 hours following initiation of graft rejection therapy. The allograft is presumed to be lost on the day the patient starts dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|Up to Month 12|Intent to Treat Population (Randomized Patients)||Participants|||Number
168036|NCT00154310|Primary|Renal Function (Nankivell Formula) at Month 12 Post Transplantation.|Renal function at the end of the trial assessed as mean absolute values of the glomerular filtration rate (GFR) calculated by Nankivell formula 12 months after renal transplantation. The Nankivell formula: GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)^2 + C ; where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. Estimated GFR is expressed in mL/min per 1.73m^2.|at Month 12 post transplantation|Intent to Treat Population (randomized patients); Last Observation Carried Forward (LOCF). One patient in||mL/min /1.73m^2||Standard Deviation|Mean
168037|NCT00154297|Secondary|Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period|A wound was considered healed if all the suture material and staples were removed and the wound was intact by 3 weeks. Any wound opened beyond this point, infected, drained fluid or herniated was considered not healed.|Month 12|Intention to treat (ITT) population.||Participants|||Number
168038|NCT00154297|Secondary|Duration of Dialysis|The mean duration in days of any dialysis session that occurred within the 12 month treatment period.|12 months|The number of patients analyzed includes those with any dialysis in the 12 month period||Days||Standard Deviation|Mean
168039|NCT00154297|Secondary|Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period|The number of patients who underwent any dialysis within the 12-month treatment period.|Month 12|Intention to treat (ITT) population.||Participants|||Number
168040|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.|"The primary efficacy variable was the “primary failure endpoint” at 12 months defined as the occurrence of one or more of the following events within the first 12 months:~delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation~efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)~wound healing disorder related to initial transplant surgery"|at 12 Month post-transplantation|Intention to treat (ITT) population.||Participants|||Number
168041|NCT00154297|Secondary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.|"The primary efficacy variable was the “primary failure endpoint” at 6 months defined as the occurrence of one or more of the following events within the first 6 months:~delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-transplantation excluding the first day post-transplantation~efficacy failure (biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up)~wound healing disorder related to initial transplant surgery"|at 6 Month post-transplantation|Intention to treat (ITT) population.||Participants|||Number
168042|NCT00154297|Primary|Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months|“In Failure”, is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).|Month 3|Intention to treat (ITT) population.||Participants|||Number
168043|NCT00154284|Secondary|Safety Based on Adverse Event (AE) Reporting||12 month||||||
168044|NCT00154284|Secondary|Calculated Creatinine Clearance at 6 Month and 12 Month|"Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl[mL/min]) is shown below:~CrCl[mL/min] = (140 – A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit [kg], C is the serum concentration of creatinine [mg/dL], R = 1 if the patient is male and = 0.85 if female."|6 month and 12 months|Intention to treat (ITT) population.||mL/min||Standard Deviation|Mean
168045|NCT00154284|Secondary|Serum Creatinine at Month 6 and 12|serum creatinine summarized by mean and standard deviation|6 month and 12 months|Intention to treat (ITT) population.||µmol/L||Standard Deviation|Mean
168046|NCT00154284|Secondary|Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up|Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.|Month 12|Intention to treat (ITT) population.||Participants|||Number
168047|NCT00154284|Primary|Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)|"Nankivell’s formula for calculated GFR is shown below:~GFR [mL/min] = 6.7/C + W/4 – UREA/2 – 100/H2+ 35 (25 for females). Where W is body weight at specific visit [kg], H is height at specific visit [m], C is the serum concentration of creatinine [mmol/L], and UREA is the serum concentration of urea [mmol/L]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441*BUN. If a GFR value from Nankivell formula was less than 10 [mL/min], then the value was assigned as 10 [mL/min]."|At Month 3 and Month 12|Intention to treat (ITT) population.||mL/min per 1.73 m^2||Standard Deviation|Mean
168048|NCT00154102|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|Safety Population||participants|||Number
168049|NCT00154102|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 in the Cetuximab + FOLFIRI arm and 559 in the FOLFIRI alone arm) completed at least one evaluable QLQ-C30 questionnaire and were thus included in the Evaluable for QLQ-C30 population||scores on a scale||Standard Error|Least Squares Mean
168050|NCT00154102|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|1125 subjects (566 Cetuximab + FOLFIRI; 559 FOLFIRI alone) completed at least 1 evaluable questionnaire & were included in the Evaluable for QLQ-C30 population. Numbers at each timepoint were (Cetuximab + FOLFORI/FOLFORI alone, respectively): baseline 430/423; Week 8 421/390; Week 16 312/309; Week 24 255/244; Week 32 164/154; Week 40 122/96||scores on a scale||Standard Error|Least Squares Mean
168051|NCT00154102|Secondary|Participants With No Residual Tumor After Metastatic Surgery|Participants with no residual tumor after on-study surgery for metastases|time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007|ITT population (allocation to treatment groups as randomized and treated)||Participants|||Number
168052|NCT00154102|Secondary|Duration of Response - Independent Review Committee (IRC) Assessments|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)||months||95% Confidence Interval|Median
168053|NCT00154102|Secondary|Disease Control Rate - Independent Review Committee (IRC) Assessments|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)||percentage of participants||95% Confidence Interval|Number
168065|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 1 , the number of missed work or school because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
168054|NCT00154102|Secondary|Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009||percentage of participants||95% Confidence Interval|Number
168055|NCT00154102|Secondary|Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009||percentage participants||95% Confidence Interval|Number
168056|NCT00154102|Secondary|Best Overall Response Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|ITT population (allocation to treatment groups as randomized and treated)||percentage of participants||95% Confidence Interval|Number
168057|NCT00154102|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
168058|NCT00154102|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
168059|NCT00154102|Secondary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009|ITT population (allocation to treatment groups as randomized and treated)||months||95% Confidence Interval|Median
168060|NCT00154102|Primary|Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
168061|NCT00154102|Primary|Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Intent to Treat (ITT) population with KRAS Wild Type tumor status as collected until 28 August 2009||months||95% Confidence Interval|Median
168062|NCT00154102|Primary|Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006|Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
168063|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. The data is presented as percentage of participants.|Week 5 to Week 19|ITT Population||Percentage of Participants|||Number
168064|NCT00154063|Secondary|Percentage of Participants With a Greater Than or Equal to 50% Decrease in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Week 5 to Week 19|ITT Population||Percentage of Participants|||Number
168066|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Non-Work Activities|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 5, the number of days when participant miss leisure or social activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
168067|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Missed Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 3, the number of days when participant skipped performing household chores or regular household activities because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
168068|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Work or School|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 2, the number of days with reduced productivity by at least half at school or work because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
168069|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Less Housework|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 4, the number of days when productivity in household work reduced by half of more because of a headache was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
168070|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headaches|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 6, the number of days with headache (Headache which lasted more than one day was counted as each day) was assessed. The data is presented as mean days +/- standard deviation.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||Days||Standard Deviation|Mean
168071|NCT00154063|Secondary|Change From Baseline of Migraine Disability Assessment Questionnaire Score (MIDAS) at Week 23: Headache Pain Score|The MIDAS questionnaire was a participant assessed 7-item questionnaire designed to measure the impact of headache in the last 3 months. Based on question 7, pain due to headache was assessed on a scale of 0-10 with 0 being no pain and 10 being the most painful.|Baseline, Week 23|ITT Population. Only patients with non-missing baseline data are summarized.||units on a scale||Standard Deviation|Mean
168072|NCT00154063|Secondary|Change From Baseline in Number of Participants With Patient Global Impression of Change (PGIC) of Migraine (LOCF)|"The PGIC was a self-evaluation scale for each patient to assess his or her status compared to baseline in migraine headache frequency and intensity, the occurrence of adverse events, and overall functional status, measured on a 7-point scale. The scale ranges from very much improved with a score of 1 to very much worse with a score of 7. A responder is defined as being very much improved or much improved. The data is presented as number of participants. LOCF = last observation carried forward (ie, observation from last phase with active treatment)"|Baseline to Week 23|ITT Population||Participants|||Number
168073|NCT00154063|Secondary|Change From Baseline in Number of Days With Migraine Attack Per 28 Days in Treatment Phase (LOCF)|A migraine attack day was defined as a calendar day (from 0 hours to 24 hours) during which at least one migraine attack took place. If the migraine attack continues through midnight, each day will be counted separately. Efficacy analyses were performed using both the 24-hour and 48-hour rule. Data is presented as mean number of days with migraine attack per 28 days +/- standard error.|Baseline to Week 19|ITT Population||Days||Standard Error|Mean
168074|NCT00154063|Secondary|Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF)|The number of days requiring symptomatic rescue medication was calculated as the number of calender days during the migraine attack when the patient took one or more migraine rescue medications as recorded on the participant's diary. The calendar date(s) during which medication was taken will be used for calculations. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean days +/- standard error.|Baseline to Week 19|ITT Population||Days||Standard Error|Mean
168075|NCT00154063|Primary|Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment)|Baseline to Week 19|The efficacy analysis was performed on the Intention to treat (ITT) Population, which was defined as all randomized subjects who received at least 1 dose of double-blind study medication, and had baseline and postbaseline migraine assessments in at least 1 phase.||Migraine period||Standard Error|Mean
168076|NCT00154063|Secondary|Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase|A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline.|Baseline, Week 11 to Week 19|ITT Population||Migraine period||Standard Error|Mean
168132|NCT00153101|Secondary|ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria|ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria|56 months|FAS of the ONTARGET trial||participants|||Number
168077|NCT00154063|Secondary|Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)|Qualified migraine headache was defined as two major subtypes: migraine without aura(headache that lasted 4-72 hours with at least two characteristics: unilateral location, pulsating quality, moderate/ severe pain intensity or aggravation by/ causing avoidance of routine physical activity and either nausea/ vomiting or photophobia,phonophobia); migraine with aura (attack with reversible focal neurological symptoms that usually precede or sometimes accompany the headache) per Migraine Criteria of the Headache Classification Committee of the International Headache Society. All of the qualified headaches, which occur after the initial qualified migraine headache, but within 24 hours of previous qualified migraine headache, were collapsed into one qualified migraine attack. Two qualified migraine attacks were considered to be distinct when the end of previous and the beginning of the next migraine attack were separated by at least 24/48 hours per 24/48 hour rule.|Baseline to Week 19|ITT Population||Migraine attack||Standard Error|Mean
168078|NCT00154063|Secondary|Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF)|The average migraine attack severity in each treatment phase was calculated using the sum of the severity of migraine attacks during the treatment phase, divided by the number of qualified migraine attacks. The scale of severity for each migraine attack ranges from 0 to 100, with higher scores indicating increased migraine severity. Efficacy analyses were performed using both the 24-hour and 48-hour rule.|Baseline to Week 19|ITT Population||Units on a Scale||Standard Error|Mean
168079|NCT00154063|Secondary|Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF)|The duration of a migraine attack was the sum of the duration (in hours) of each migraine headache that was collapsed to form the migraine attack. The time between the offset of first migraine headache and the onset of the next migraine headache was not counted in the duration of migraine attack. The average duration of the migraine attacks in each phase was calculated as the total duration (in hours) of the migraine attacks during each phase, divided by the number of migraine attacks in the corresponding treatment phase. Efficacy analyses were performed using both the 24-hour and 48-hour rule. The data is presented as mean hours +/- standard error.|Baseline to Week 19|ITT Population||Hours||Standard Error|Mean
168080|NCT00153985|Secondary|The Incidence of Grade II-IV Acute Graft vs. Host Disease.|Outcome was measured by incidence and severity of acute and chronic GVHD following donor stem cell infusion.|3 years|All patients enrolled.||participants|||Number
168081|NCT00153985|Secondary|Solid Organ Toxicity Related to the Conditioning Regimen.|Outcome was measured by the assessment of organ toxicity related to Busulfex, fludarabine and alemtuzumab.|3 years|All patients enrolled.||participants|||Number
168082|NCT00153985|Primary|Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy.|Outcome was measured by ANC >500 for three consecutive days prior to day 30 after PBSC infusion, >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods prior to day 45 after PBSC infusion and >25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods after day 180 after PBSC infusion.|3 years|All patients enrolled.||participants|||Number
168083|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.||Number of subjects|||Number
168084|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 5 (week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.||Number of subjects|||Number
168085|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 7 (week 48)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 7 (week 48) assessment had to be present.||Number of subjects|||Number
168097|NCT00152516|Secondary|Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase|"The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.~Note: Rates were reported as percentages."|Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.||Percentage of Participants|||Number
168086|NCT00152516|Secondary|Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)|This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where ‘Improved’ is any positive category change, ‘Stable’ is no category change, and ‘Worsened’ is any negative category change, from baseline.|Visit 5 (Week 24)|The Bayley Scale of Infant Development (BSID) II assessment was performed only at selected sites where a neuropsychologist was available. Both a valid baseline and Visit 5 (week 24) assessment had to be present.||Number of subjects|||Number
168087|NCT00152516|Secondary|Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)|The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.|Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)|At baseline there were 98 subjects with valid Memory Screen composite scores (mean=85.5, standard deviation=18.7). Of these 98 subjects, 87 had valid scores at Visit 5 (week 24) and 80 at Visit 7 (week 48).||Score on a scale||Standard Deviation|Mean
168088|NCT00152516|Secondary|Subject (>=8 Years Old) Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects >= 8 years old for whom the assessment was performed||Percentage of Participants|||Number
168089|NCT00152516|Secondary|Parent/Guardian Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed||Percentage of Participants|||Number
168090|NCT00152516|Secondary|Investigator Global Evaluation Scale|There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).|End of Evaluation period (week 48 or at point of early discontinuation)|Intention to Treat (ITT) subjects for whom the assessment was performed||Percentage of Participants|||Number
168091|NCT00152516|Secondary|Percent of Subjects With Each Seizure Type During the Evaluation Period|"Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).~Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).~Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).~A subject could experience more than one seizure type."|Evaluation period (48 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data.||Percentage of Participants|||Number
168092|NCT00152516|Secondary|Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period|"The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.~The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks."|greater than or equal to 24 weeks, greater than or equal to 40 weeks|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.||Percentage of Participants|||Number
168093|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) subjects with > 24 weeks of exposure and treatment period seizure data||Percentage of Days||Inter-Quartile Range|Median
168094|NCT00152516|Secondary|Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) Subjects with <= 24 Weeks of Exposure and treatment period seizure data||Percentage of Days||Inter-Quartile Range|Median
168095|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with greater than 24 weeks of exposure|Intention to Treat (ITT) Subjects with > 24 Weeks of Exposure and treatment period seizure data||Percentage of days||Inter-Quartile Range|Median
168096|NCT00152516|Secondary|Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)|For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.|Subjects with up to 24 weeks of exposure|Intention to Treat (ITT) subjects with <= 24 Weeks of Exposure and treatment period seizure data||Percentage of Days||Inter-Quartile Range|Median
168111|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Diabetes|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only for patients of TRANSCEND trial treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline.||participants|||Number
168098|NCT00152516|Secondary|Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
168099|NCT00152516|Secondary|Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline and 1 was missing treatment period seizure data. The result was a sample size of 250. Of these 250 subjects 229 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
168100|NCT00152516|Secondary|Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
168101|NCT00152516|Secondary|Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.||Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 1 was missing treatment period seizure data leaving a sample size of 254. Of these 254 subjects 233 continued into the maintenance period.||Seizures Per Week||Inter-Quartile Range|Median
168102|NCT00152516|Secondary|Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 2 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 248. Of these 248 subjects 227 continued into the maintenance period.||Percent Reduction in Seizures per Week||Inter-Quartile Range|Median
168103|NCT00152516|Primary|Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.|Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.|Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)|255 subjects were Intention to Treat (ITT), i.e. all subjects with at least 1 dose of study medication. Of these 255 ITT subjects 4 were missing a baseline, 3 had a baseline of 0, and 1 was missing treatment period seizure data. The result was a sample size of 247. Of these 247 subjects 226 continued into the maintenance period.||percent reduction in seizures Per Week||Inter-Quartile Range|Median
168104|NCT00153179|Primary|Difference in Insulin-mediated Skeletal Muscle Glucose Utilization Between Test Agent and Placebo||7 days||||||
168105|NCT00153179|Primary|Difference in Flow-mediated, Endothelium-dependent Brachial Artery Vasodilation Between Test Agent and Placebo||7 days||||||
168106|NCT00153179|Primary|Flow-mediated Dilation After Placebo or Acipimox Treatment Between Healthy Controls and Those With Metabolic Syndrome|Flow mediated dilation is calculated as follows: A resting arterial diameter measurement is obtained using the average of 10 EKG-gated ultrasound images. Next, an occlusive pressure is applied (using a blood pressure cuff inflated to a suprasystolic pressure)for a period of 5 minutes. After 5 minutes, the cuff is rapidly deflated. This produces a reactive hyperemic response which is captured via ultrasound at 1 minute post cuff deflation (also 10 EKG-gated images averaged). The diameter of the artery following reactive hyperemia is calculated and compared to the resting diameter to obtain a percent dilation. This is flow-mediated dilation.|7 days|||Flow mediated dilation||Standard Deviation|Mean
168107|NCT00153166|Secondary|'M' = Whole Body Insulin Sensitivity|A hyperinsulinemic-euglycemic clamp was performed prior to and during FDG-PET imaging to measure insulin sensitivity and to standardize metabolic conditions. Subjects were required to fast for 8 hours prior to the study. Patients were given a primed insulin infusion of 2 mU/kg/min. Serum glucose measurements were made at five-minute intervals from an arterialized venous sample achieved by placing the hand in a warming box at 50°C. Blood glucose levels are checked every 5 minutes and 20% dextrose infusion is adjusted to maintain a serum glucose level of approximately 80 mg/dL. Subjects were considered to have achieved steady state when the dextrose infusion rate required to maintain a serum glucose level of 80 mg/dL varied by no greater than 5%. To compute the steady-state glucose disposal rate, we averaged the glucose infusion rates over the last 20 minutes of the clamp and applied a “space correction” to account for small changes in serum glucose levels over that time period.|every 5 minutes for 20 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.||mg/kg/min||Inter-Quartile Range|Median
168108|NCT00153166|Primary|Lower Extremity Skeletal Muscle Glucose Uptake|Net calf skeletal muscle glucose uptake determined by Patlak modeling.|60 minutes|Baseline Characteristics were collected according to the clinical diagnosis of the patients and not according to randomization. Participants were grouped at Baseline and are presented here irrespective of randomization because the primary intention was to compare the different types of patients regardless of interventions received.||umol/kg/min||Standard Deviation|Mean
168109|NCT00153101|Secondary|TRANSCEND. Newly Diagnosed Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
168110|NCT00153101|Secondary|TRANSCEND. Cardiovascular Revascularization Procedure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
168112|NCT00153101|Secondary|TRANSCEND. Cognitive Decline|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the TRANSCEND trial treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.||participants|||Number
168113|NCT00153101|Secondary|TRANSCEND. New Onset of Atrial Fibrillation|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
168114|NCT00153101|Secondary|TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria|TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR <30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.|56 months|FAS of the TRANSCEND trial||participants|||Number
168115|NCT00153101|Secondary|TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria|56 months|FAS of the TRANSCEND trial||participants|||Number
168116|NCT00153101|Secondary|TRANSCEND. New Macroalbuminuria|TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine [Crea] in patients with a UACR <300 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial||participants|||Number
168117|NCT00153101|Secondary|TRANSCEND. New Microalbuminuria|TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine [Crea] in patients with a UACR <30 mg/g Crea at baseline|56 months|FAS of the TRANSCEND trial||participants|||Number
168118|NCT00153101|Secondary|TRANSCEND. Progression to ESRD|TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73m²|56 months|FAS of the TRANSCEND trial||participants|||Number
168119|NCT00153101|Secondary|TRANSCEND. Doubling of Serum Creatinine|TRANSCEND. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the TRANSCEND trial||participants|||Number
168120|NCT00153101|Secondary|TRANSCEND. Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
168121|NCT00153101|Secondary|TRANSCEND. Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).|56 months|FAS of the TRANSCEND trial||participants|||Number
168122|NCT00153101|Secondary|TRANSCEND. Non-fatal Myocardial Infarction|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the TRANSCEND trial||participants|||Number
168123|NCT00153101|Secondary|TRANSCEND. Cardiovascular Death|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the TRANSCEND trial||participants|||Number
168124|NCT00153101|Primary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial||participants|||Number
168125|NCT00153101|Secondary|TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the TRANSCEND trial||participants|||Number
168126|NCT00153101|Secondary|ONTARGET. New Onset of Atrial Fibrillation|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline.||participants|||Number
168127|NCT00153101|Secondary|ONTARGET. Cognitive Decline|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.||participants|||Number
168128|NCT00153101|Secondary|ONTARGET. Newly Diagnosed Diabetes|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.|56 months|Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes.||participants|||Number
168129|NCT00153101|Secondary|ONTARGET. Cardiovascular Revascularization Procedure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).|56 months|FAS of the ONTARGET trial||participants|||Number
169525|NCT00135330|Secondary|Hypoglycemia Rate Per 30 Days Per Patient|Average number of episodes of hypoglycemia per 30 days per patient|20 weeks|Full Analysis Set||hypoglycemia events / 30 days / patient||Standard Deviation|Mean
168134|NCT00153101|Secondary|ONTARGET. New Microalbuminuria|ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio <30 mg/g Crea at baseline.|56 months|FAS of the ONTARGET trial||participants|||Number
168135|NCT00153101|Primary|ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients|"ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.~These renal outcomes were not adjudicated (apart from death)."|56 months|Subset of the Full Analysis Set (FAS [DN]) consisting of all randomised patients with diabetic nephropathy (UACR ≥300 mg/g Crea) of the ONTARGET trial.||participants|||Number
168136|NCT00153101|Secondary|ONTARGET. Progression to ESRD|ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m².|56 months|FAS of the ONTARGET trial||participants|||Number
168137|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine|ONTARGET. Nephropathy subcategory: doubling of serum creatinine|56 months|FAS of the ONTARGET trial||participants|||Number
168138|NCT00153101|Secondary|ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial||participants|||Number
168139|NCT00153101|Secondary|ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients|ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR <15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial||participants|||Number
168140|NCT00153101|Secondary|ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients|Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.|56 months|FAS [DN] of the ONTARGET trial||participants|||Number
168141|NCT00153101|Secondary|ONTARGET. Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial||participants|||Number
168142|NCT00153101|Secondary|ONTARGET. Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.|56 months|FAS of the ONTARGET trial||participants|||Number
168143|NCT00153101|Secondary|ONTARGET. Non-fatal Myocardial Infarction|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction.|56 months|FAS of the ONTARGET trial||participants|||Number
168144|NCT00153101|Secondary|ONTARGET. Cardiovascular Death|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.|56 months|FAS of the ONTARGET trial||participants|||Number
168145|NCT00153101|Secondary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke|56 months|FAS of the ONTARGET trial||participants|||Number
168146|NCT00153101|Primary|ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure|The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|56 months|FAS of the ONTARGET trial||participants|||Number
168147|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)||time since randomization; follow-up period is 1.5 to 4.4 years|||Participants|||Number
168148|NCT00153062|Secondary|Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)||Randomization to final patient contact|Patients who did not have diabetes mellitus at baseline were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
168149|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)|Number of patients with any of stroke, myocardial infarction, vascular death, or new or worsening congestive heart failure|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
168150|NCT00153062|Secondary|Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)|Number of patients with any of stroke, myocardial infarction, vascular death|time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
168151|NCT00153062|Primary|Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)||time since randomization; follow-up period is 1.5 to 4.4 years|Patients were analyzed as randomized and were included in the analysis until final patient contact regardless of whether they were still on treatment.||Participants|||Number
168169|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
168170|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at Baseline|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
168152|NCT00152971|Secondary|Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period|"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma greater than or equal to 25 cm²~wound hematoma greater than or equal to 100 cm²~spontaneous nose bleed lasting longer than 5 min~macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention~spontaneous rectal bleeding (more than a spot on toilet paper)~gingival bleeding lasting longer than 5 min~any other bleeding event considered clinically relevant by the investigator~Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above."|First administration until 12-15 days|Treated set||Participants|||Number
168153|NCT00152971|Secondary|Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period|Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).|3 months|Patients with any data available during follow-up||Participants|||Number
168154|NCT00152971|Secondary|Number of Participants Who Died During Treatment Period|All cause death, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op||Participants|||Number
168155|NCT00152971|Secondary|Number of Participants With Pulmonary Embolism During Treatment Period|Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op||Participants|||Number
168156|NCT00152971|Secondary|Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period|Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - op (all patients who are treated and operated)||Participants|||Number
168157|NCT00152971|Secondary|Number of Participants With Total Deep Vein Thrombosis During Treatment Period|Total Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
168158|NCT00152971|Secondary|Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period|Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - pDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)||Participants|||Number
168159|NCT00152971|Secondary|Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period|Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee|First administration until 12-15 days|Full Analysis Set - major (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)||Participants|||Number
168160|NCT00152971|Primary|Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period|"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients."|First administration until 12-15 days|Full Analysis Set (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)||Participants|||Number
168161|NCT00152763|Secondary|Percentage of Participants Who Received ICD Therapies|Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.|12-months follow-up|||Percentage of participants|||Number
168162|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 12-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
168163|NCT00152763|Secondary|SF-36 Physical Component Summary Score at 6-months Follow-up|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
168164|NCT00152763|Secondary|SF-36 Physical Component Summary Score at Baseline|Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.|Baseline|||units on a scale||Standard Deviation|Mean
168165|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
168166|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
168167|NCT00152763|Primary|Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline|Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
168168|NCT00152763|Primary|Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
168171|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Twelve-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis||units on a scale||Standard Deviation|Mean
168172|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Six-months follow-up|Intention to treat analysis although data from participants who died were omitted from analysis||units on a scale||Standard Deviation|Mean
168173|NCT00152763|Primary|Impact of Events Scale-Revised - Avoidance Scale at Baseline|Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.|Baseline|Intention to treat analysis although data from participants who died were omitted from analysis||units on a scale||Standard Deviation|Mean
168174|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
168175|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
168176|NCT00152763|Primary|Impact of Events Scale-Revised - Intrusiveness Scale at Baseline|Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
168177|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 12-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Twelve-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168178|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at 6-months Follow-up|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Six-months follow-up|Intention to treat analysis although data for participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168179|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 12-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Twelve-months follow-up|||units on a scale||Standard Deviation|Mean
168180|NCT00152763|Primary|Impact of Events Scale-Revised - Total Score at Baseline|Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.|Baseline|Intention to treat analysis although data for participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168181|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168182|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168183|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline|Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168184|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Twelve-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168185|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at 6-months Follow-up|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Six-months follow-up|||units on a scale||Standard Deviation|Mean
168186|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Six-months follow-up|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168187|NCT00152763|Secondary|SF-36 Mental Component Summary Scale at Baseline|Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.|Baseline|||units on a scale||Standard Deviation|Mean
168188|NCT00152763|Primary|Hospital Anxiety and Depression Scale - Depression Scale at Baseline|Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.|Baseline|Intention to treat analyses but data on participants who died over follow-up were omitted.||units on a scale||Standard Deviation|Mean
168189|NCT00152009|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 5 weeks|ITT||Units on a scale||Standard Error|Least Squares Mean
168190|NCT00152009|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT||Participants|||Number
168191|NCT00152009|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 5 weeks|ITT||Participants|||Number
168192|NCT00152009|Secondary|Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks|The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT||Units on a Scale||Standard Error|Least Squares Mean
168193|NCT00152009|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 5 weeks|ITT||Units on a Scale||Standard Error|Least Squares Mean
168194|NCT00152009|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 5 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the baseline and at least one post-randomization primary efficacy measurement.||Units on a Scale||Standard Error|Least Squares Mean
168195|NCT00151996|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100 for each. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|FAS||Units on a scale||Standard Deviation|Mean
168196|NCT00151996|Secondary|Number of Participants With Improvement on Parent Global Assessment (PGA) Scores|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). The PGA is designed to capture parent's opinions of their child's disease (ADHD) severity and improvement. Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Participants|||Number
168197|NCT00151996|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks|The Conner's Parent Rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|FAS||Units on a Scale||Standard Deviation|Mean
168198|NCT00151996|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Participants|||Number
168199|NCT00151996|Primary|Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects with a baseline and at least one post-baseline efficacy measurement.||Units on a Scale||Standard Deviation|Mean
168200|NCT00151892|Secondary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score|Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.|6 Months|Intent to treat (ITT) population defined as all randomized subjects who received at least 1 dose of investigational product. Analysis includes patients who completed an SIBDQ questionnaire at 6 months.||Units on a scale||Standard Deviation|Mean
168201|NCT00151892|Secondary|Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months|The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.|Baseline and 6 months|PP||Units on a scale||Standard Deviation|Mean
168202|NCT00151892|Secondary|Endoscopic Remission of UC With No or Mild Symptoms at 6 Months|Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).|6 Months|PP||percent of participants|||Number
168203|NCT00151892|Secondary|Withdrawal Due to Relapse of UC|Relapse is defined as withdrawal from the study due to lack of efficacy.|Over 6 Months|PP||percent of participants|||Number
168204|NCT00151892|Primary|Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months|Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].|6 Months|Per Protocol Population (PP) defined as all subjects who either completed the study or withdrew for reasons related to efficacy or AEs and who were deemed to be protocol-compliant.||percent of participants|||Number
168205|NCT00151814|Primary|For Olmesartan, the Apparent Oral Volume of Distribution||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||L||Standard Deviation|Mean
168206|NCT00151814|Primary|For Olmesartan, the Apparent Oral Clearance||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||L/hr||Standard Deviation|Mean
168207|NCT00151814|Primary|For Olmesartan, the Elimination Half-life of the Drug in Plasma||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||hr||Standard Deviation|Mean
168208|NCT00151814|Primary|Foe Olmesartan, the Time of Maximum Plasma Concentration||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||hr||Standard Deviation|Mean
168209|NCT00151814|Primary|For Olmesartan, the Maximum Plasma Concentration Over the Entire Sampling Phase||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||ng/mL||Standard Deviation|Mean
168210|NCT00151814|Primary|For Olmesartan, the Elimination Constant Rate||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||L/hr||Standard Deviation|Mean
168211|NCT00151814|Primary|For Olmesartan, Area Under the Concentration-time Curve From the Time of the Dose to Infinity||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||ng/mL*hr||Standard Deviation|Mean
168212|NCT00151814|Primary|For Olmesartan, the Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC 0-t)||PK samples were collected pre-dose and at 1,2,4,8,12,24,48 hours after dosing|24 participants were enrolled; however, the data for the four 2-5 years old participants were not analyzed.||ng/mL*hr||Standard Deviation|Mean
168213|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.|Day 0 to week 51 week (end of study)|57=the number of participants who received medication in Period 4||mm Hg||Standard Deviation|Mean
168214|NCT00151775|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)|Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 to week 51 (end of study)|Intent to treat population includes participants with at least one visit in Period 4.||mm Hg||Standard Deviation|Mean
168215|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.||mm Hg||Standard Deviation|Mean
168216|NCT00151775|Secondary|Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3|Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Week 3 (period 3 baseline) to week 5 (end of Period 3)|Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.||mm Hg||Standard Deviation|Mean
168217|NCT00151775|Primary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)|Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.|Day 0 (baseline) to 3 weeks|The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used||mm Hg||Standard Deviation|Mean
168218|NCT00151775|Primary|Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)|The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.|Day 0 to 3 weeks|The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.||mm Hg||Standard Error|Least Squares Mean
168307|NCT00149890|Secondary|Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation|Graft loss is defined as being listed for a re-transplantation.|3 months and 6 months|safety/Intent to Treat (ITT) population||Percentage of participants|||Number
168219|NCT00151476|Secondary|Rectal or Pouch Adenoma Burden Based on Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline).|Baseline, 6 to 14 months post-baseline, EOS|All subjects; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.||particpants|||Number
168220|NCT00151476|Secondary|Duodenal Adenoma Burden as Measured by Spigelman Stage|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: Spigelman stage provides index of disease severity based on number of polyps, polyp size, histology, and dysplasia; range is Stage 0 (none) to Stage IV (severe). EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Spigelman Stage not completed as staging data largely missing; see measure: Duodenal adenoma burden as measured by polyp counts.|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing.||participants|||Number
168221|NCT00151476|Post-Hoc|Duodenal Adenoma Burden as Measured by Polyp Counts|Number of subjects with polyp burden as assessed in most recent prior polyps evaluation: attenuated: <100 polyps, mild: between 100 to 1000 polyps, severe: >1000 polyps. EOS: endoscopic examination closest to end of on-study celecoxib or index period (within 6 months of end of celecoxib or index period and prior to intake of any exclusionary medications after baseline). Post-hoc analysis of duodenal polyp burden in terms of severity categories and based on polyp numbers; Spigelman Stage not completed as staging data largely missing (see: Duodenal adenoma burden as measured by Spigelman Stage)|Baseline, 6 to 14 months post-baseline, End of study (EOS)|All subjects; Spigelman Stage not completed as staging data largely missing; duodenal polyp burden analyzed in terms of severity categories and based on polyp numbers.||participants|||Number
168222|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had IPAA prior to start of study follow-up); data censored (n=5) for control group subjects (no data).||months||Full Range|Median
168223|NCT00151476|Secondary|Time From Post IRA to Time of Conversion From IRA to IPAA|Time (months): [date of IPAA minus date of prior IRA plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; data censored (n=5) for control group subjects (no data).||months||Full Range|Median
168224|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of the most recent prior FAP-related surgery, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left-censored subjects (had any FAP-related adverse event between the date of most recent FAP-related surgical event performed prior to start of study follow-up, or onset of FAP phenotype (no prior FAP-related surgery), and start of study follow-up.||months||Full Range|Median
168225|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First FAP-related Adverse Event|Time (months): [date of first FAP-related adverse event, occurring after the date of most recent prior FAP-related surgery, or date of FAP diagnosis minus date of most recent prior FAP-related surgery, or date of FAP diagnosis plus 1] divided by 30.44. FAP-related adverse event defined as any FAP related cancers, desmoid tumors requiring procedural intervention, hospitalizations or procedural interventions, or death related to FAP (i.e., as a consequence of FAP, FAP complications, or a procedure or drug used to treat FAP-related medical problems).|Up to 15 years prior to baseline|All eligible subjects; first FAP-related adverse event (FAP-related cancers, desmoid tumors requiring procedural intervention, hospitalizations, procedural interventions, or death related to FAP) after subject's most recent FAP-related surgical event performed prior to start of study follow-up, onset of FAP phenotype (no prior FAP-related surgery).||months||Full Range|Median
168226|NCT00151476|Secondary|Time From Start of Study Follow-up to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas, occurring after date of most recent prior FAP-related surgical event, or date of FAP diagnosis minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects included, except left censored subjects (had any excisional or ablational event for rectal, colonic, pouch, or duodenal adenomas between date of most recent FAP-related surgical event performed prior to the start of study follow-up, or onset of FAP phenotype [with no prior FAP-related surgery], and start of study follow-up).||months||Standard Deviation|Mean
168227|NCT00151476|Secondary|Time From Most Recent Prior FAP-related Surgical Event or Onset of FAP Phenotype to Time of First Excisional or Ablational Event for Rectal, Colonic, Pouch, or Duodenal Adenomas (Duodenal Adenomatous Polyps)|Time (months): [date of first excisional or ablational event for colonic, pouch, or duodenal adenomas occuring after date of most recent prior FAP-related surgical event or date of FAP diagnosis minus date of most recent prior FAP-related surgical event or date of FAP diagnosis plus 1] divided by 30.44.|Up to 15 years prior to baseline|All eligible subjects; first excisional or ablational event for rectal adenomas that does not qualify for primary efficacy endpoint; after most recent FAP-related surgical event prior to start of study follow-up or onset of FAP phenotype for subjects with no prior FAP-related surgery.||months||Standard Deviation|Mean
168228|NCT00151476|Primary|Time From Start of Study Follow-up to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of rectal polyp post IPAA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IPAA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy post IPAA prior to start of study follow-up). No control group subjects (n=7) had a post-IPAA polypectomy (no data).||months||Standard Deviation|Mean
168229|NCT00151476|Primary|Time From Ileopouch Anal Anastomosis (IPAA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IPAA|Time (months): [date of first excisional polypectomy of a rectal polyp post IPAA minus date of prior IPAA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.|Up to 15 years prior to baseline|All eligible subjects with IPAA performed prior to start of study follow-up included and with first excisional polypectomy of a rectal polyp post IPAA. No control group subjects (n=7) had a post-IPAA polypectomy (no data).||months||Standard Deviation|Mean
168230|NCT00151476|Primary|Time From Start of Study Follow-up to the Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of start of study follow-up plus 1] divided by 30.44.|Baseline, Up to 60 months post-baseline|All eligible subjects with IRA performed prior to start of study follow-up included, except left-censored subjects (had first excisional polypectomy of rectal polyp post IRA prior to start of study follow-up). No control group subjects (n=3) had a post-IRA polypectomy (no data).||months||Full Range|Median
168231|NCT00151476|Primary|Time From Ileorectal Anastomosis (IRA) to Time of First Excisional Polypectomy of a Rectal Polyp Post IRA|Time(months): [date of first excisional polypectomy of rectal polyp post IRA minus date of prior IRA plus 1] divided by 30.44. Baseline = start of study follow-up: start of on-study celecoxib treatment period for celecoxib-treated subjects and comparable to index date for control subjects. Index date calculated as Matched Celecoxib-treated patients: number of days from most recent FAP-related surgery (IRA or IPAA) to start of study follow-up; add this number of days to matched control patient’s most recent FAP-related surgery date=index date for Matched Control.|Up to 8 years prior to baseline|All eligible subjects with IRA performed prior to start of study follow-up; first excisional polypectomy of rectal polyp post IRA. Polyp size unavailable for many subjects; not considered in analysis.||months||Standard Deviation|Mean
168232|NCT00151411|Secondary|The Investigators Hypothesize That Combination Therapy Will Result in a Greater Improvement in Ovulatory Frequency and Insulin Sensitivity That Single Agent Therapy.||baseline and monthly, up to six months post-randomization||||||
168233|NCT00151411|Primary|Change in Testosterone After 6 Months of Treatment|The investigators hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia than single agent therapy.|baseline and 6 months|||ng/dL||95% Confidence Interval|Mean
168234|NCT00151372|Secondary|Hamilton Depression Rating Scale|The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."||points on a scale||Standard Deviation|Mean
168235|NCT00151372|Primary|Composite Antidepressant Score Scale (CAD)|The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.|28 Weeks|"Analysis was conducted on subjects actively participating in the study at the 28-week assessment. The number corresponds to Completed in the Participant Flow section."||Participants|||Number
168236|NCT00150969|Secondary|Difference in Number of New Clinical Fractures by Treatment Arm.|these included fragility fractures|up to 48 months|||events|||Number
168237|NCT00150969|Secondary|Difference in Number of New Cancers by Treatment Arm.||up to 48 months|||events|||Number
168238|NCT00150969|Secondary|Difference in Serious Adverse Events|These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.|up to 48 months|||events|||Number
168239|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
168240|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
168241|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
168242|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
168243|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 48 months|||percentage change in BMD||Standard Deviation|Mean
168244|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin|measured by osteocalcin hydroxyapatite binding assay|0 to 24 months|||percentage of undercarboxylated OC||Standard Deviation|Mean
168245|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)|measured by CTX Elisa assay on elecsys platform|0-24 months|||ng/ml||Standard Deviation|Mean
168246|NCT00150969|Secondary|Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker|measured by osteocalcin on elecsys platform|0-24 months|||ng/ml||Standard Deviation|Mean
168247|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
169526|NCT00135330|Secondary|Incidence of Hypoglycemia Events|Number of subjects experiencing hypoglycemia at any point during the study|20 weeks|Full Analysis Set||participants|||Number
168248|NCT00150969|Secondary|Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
168249|NCT00150969|Primary|Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.|BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer|0 to 24 months|For our 2 year BMD anlayses we included all 440 women based on intention to treat using last observation carried forward for missing data.||percentage change in BMD||Standard Deviation|Mean
168250|NCT00150618|Secondary|Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks|The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total scoring ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents.|Baseline and 6 weeks|ITT||units on a scale||Standard Error|Least Squares Mean
168251|NCT00150618|Secondary|Number of Participants With Improvement in Parent Global Assessment (PGA)|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT||Participants|||Number
168252|NCT00150618|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|ITT||Participants|||Number
168253|NCT00150618|Secondary|Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and 6 weeks|ITT||Units on a Scale||Standard Error|Least Squares Mean
168254|NCT00150618|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the Baseline and at least one post-randomization primary efficacy measurement.||Units on a Scale||Standard Error|Least Squares Mean
168255|NCT00150592|Secondary|Change From Baseline in Pictorial Sleepiness Scale (PSS) Scores at 6 Weeks|The Pictorial Sleepiness Scale (PSS) scores range from 1 (far left wide awake face) to 5 (far right very sleepy face). Increasing score reflects greater sleepiness.|Baseline and 6 weeks|FAS||Units on a Scale||Standard Deviation|Mean
168256|NCT00150592|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Scores at 6 Weeks|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and 6 weeks|FAS||Units on a Scale||Standard Deviation|Mean
168257|NCT00150592|Secondary|Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS||Participants|||Number
168258|NCT00150592|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks|Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who received at least one dose of investigational product.||Units on a Scale||Standard Deviation|Mean
168259|NCT00150592|Secondary|Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks|"The Spatial Working Memory (SWM) Test is a computerized assessment of working memory and strategy performance. The subject is required to find blue tokens in various displayed boxes and use the tokens to fill a column on the right side of the screen. Subjects can only find tokens in new boxes, therefore they must remember where previous tokens were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance."|Baseline and 6 weeks|PP||Units on a scale||Standard Deviation|Mean
168260|NCT00150592|Secondary|Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP||Units on a scale||Standard Deviation|Mean
168261|NCT00150592|Secondary|Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years|The Digital Symbol Substitution Task/Coding Test (DSST/Coding) assesses relative contributions of speed, memory, and visual scanning. Subjects are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time. Scores range from 0-65 in age category 6-7 years and 0-199 in age category 8-17 years. Higher scores indicate better performance.|Baseline and 6 weeks|PP||Units on a scale||Standard Deviation|Mean
168262|NCT00150592|Primary|Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks|Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.|Baseline and 6 weeks|Per protocol (PP) defined as all subjects who completed the study and were deemed to be protocol-compliant.||msec||Standard Deviation|Mean
168263|NCT00150462|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUCinf was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||ng*minute/mL||Standard Deviation|Mean
168264|NCT00150462|Primary|Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. AUClast was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2–8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||ng*minute/mL||Standard Deviation|Mean
168265|NCT00150462|Primary|Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Tmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||minutes||Standard Deviation|Mean
168266|NCT00150462|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population||days||Full Range|Median
168267|NCT00150462|Secondary|Time to Progression|"Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment.~Median time to progression was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable population||days||Full Range|Median
168268|NCT00150462|Secondary|Duration of Response|"Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment.~Median duration of response was calculated using the Kaplan-Meier method."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable participants with an objective response||days||Full Range|Median
168269|NCT00150462|Secondary|Best Clinical Response to Treatment|"Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin’s Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström’s Macroglobulinemia. The disease response criteria for Hodgkin’s Lymphoma are defined as follows:~Complete response: total resolution of measurable disease parameters.~Partial response: a ≥ 50% resolution without the appearance of new disease.~Stable disease: between < 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease.~Progressive disease: an increase of > 25% in measurable disease parameters.~Best clinical response is the best response observed from the start of study treatment until disease progression or death."|From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.|Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.||participants|||Number
168270|NCT00150462|Primary|Maximum Observed Plasma Concentration of Carfilzomib (Cmax)||Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.|Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.||ng/mL||Standard Deviation|Mean
168271|NCT00150462|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"A DLT was defined as any of the following occurring in the first 28 days of study participation:~Nonhematologic:~> Grade 2 neuropathy with pain~≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)~≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy~Hematologic:~Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support~Febrile neutropenia (ANC < 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)~Grade 4 thrombocytopenia (platelets < 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.~Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0."|28 days|Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib||participants|||Number
168272|NCT00150345|Secondary|Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned||Day 28|MITT; data not summarized as planned; data insufficient for analysis due to missing data.||participants|||Number
168273|NCT00150345|Secondary|Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned||Day 28|MITT||participants|||Number
168375|NCT00148109|Primary|Number of Patients With Sarcoma Who Are Tumor Progression Free and Alive at Four Months From Start of Treatment With Single-agent Cetuximab.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months after starting cetuximab therapy|4 months|per protocol all patients that received drug were evaluated for the primary endpoint||participants|||Number
168274|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Died). A participant must have died before Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR: no participants met this criteria within the category Died."||percent of positive PCR assessments|||Number
168275|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)|Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Alive). A participant must be evaluable until Day 28 (final visit).|Day 2 through Day 28|"MITT; participants who completed the study and had a non-missing value for percent of positive panfungal PCR. N=number of participants for category Alive."||percent of positive PCR assessments||Standard Deviation|Mean
168276|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168277|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168278|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence|Percent of positive panfungal PCR assessments during treatment phase of study in association with time to defervescence. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with time to defervescence was not summarized as planned.||percent of positive PCR assessments||Standard Deviation|Mean
168279|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
168280|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
168281|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 5 (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 5 (96 hours through 120 hours after start of study treatment)|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168282|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28|Percent of positive panfungal PCR assessments during treatment phase of study in association with proven or probable IFI (complete cases) between Day 2 and Day 28 (Yes or No). Complete case analysis: participant must be evaluable until Day 28 (final visit) or have developed a proven or probable IFI by the final visit. Participant considered evaluable until Day 28 if participant completed the study and completed an assessment of IFI at Day 28 or final visit. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168283|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
168654|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Pneumonia)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168284|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified|Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168285|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)|Percent of positive panfungal PCR assessments during treatment phase of study in association with c-reactive protein level (measured in milligrams per liter [mg/L]) >1.25 x ULN (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with c-reactive protein level was not summarized as planned.||percent of positive PCR assessments||Standard Deviation|Mean
168286|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL|Percent of positive panfungal PCR assessments during treatment phase of study in association with neutrophil count >500 uL (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168287|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole|Percent positive panfungal PCR assessments during treatment phase of study in association with use of concomitant (prophylaxis) fluconazole (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168288|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants|Percent of positive panfungal PCR assessments during treatment phase of study in association with allogeneic bone marrow transplant or allogeneic peripheral stem cell transplant (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168289|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease|Percent of positive panfungal PCR assessments during treatment phase of study in association with primary underlying neoplastic disease. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168290|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender|Percent of positive panfungal PCR assessments during treatment phase of study in association with gender (Female or Male). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; (n)=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR for immediate voriconazole and deferred voriconazole treatment, respectively.||percent of positive PCR assessments||Standard Deviation|Mean
168291|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age|Percent of positive panfungal PCR assessments during treatment phase of study in association with age for participants who completed the study and have a non-missing value for percent of positive panfungal PCR.|Day 2 through Day 28|MITT. Correlation of positive panfungal PCR assessments with age was not summarized as planned.||percent of positive PCR assessments||Standard Deviation|Mean
168292|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=No). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
168293|NCT00150345|Secondary|Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)|Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=Yes). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.|Day 2 through Day 28|MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR.||percent of positive PCR assessments||Standard Deviation|Mean
168308|NCT00149890|Secondary|Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months|To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months.|3 and 6 months|safety/Intent to Treat (ITT) population||Participants|||Number
168294|NCT00150345|Secondary|Time to Negative Panfungal Polymerase Chain Reaction (PCR)|Time (in days) from start of study medication to negative panfungal PCR; assessed for participants whose most recent panfungal PCR result prior to start of study medication was positive. Defined as negative if at least 2 successive and all following panfungal PCR assessments from start of study medication until 24 hours after end of treatment are negative. Measured as first quartile of time (point in time measurement; no median or measure of dispersion calculated); median time was not estimable for deferred voriconazole treatment group.|Day 2 through Day 28|MITT; N=number of participants whose most recent panfungal PCR result prior to start of study medication was positive.||days|||Number
168295|NCT00150345|Secondary|Number of Participants That Died on or Before Day 28 (Mortality)|Number of participants that died on or before Day 28 after start of study treatment. A participant must be evaluable until Day 28 (final visit) or have died before the final visit.|Day 2 through Day 28|MITT; N=number of participants evaluable until Day 28 (final visit) or died before the final visit.||participants|||Number
168296|NCT00150345|Secondary|Number of Participants Per Reason for Lack of Defervescence||Day 2 through Day 28|MITT||participants|||Number
168297|NCT00150345|Secondary|Time to Continuous Defervescence|Time (in days) from start of study medication to continuous defervescence. Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours.|Day 2 through Day 28|MITT||days||95% Confidence Interval|Median
168298|NCT00150345|Secondary|Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participant's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 9 (192 hours through 216 hours after start of study treatment)|MITT||particpants|||Number
168299|NCT00150345|Secondary|Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)|Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participants's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).|Day 5 (96 hours through 120 hours after start of study treatment)|MITT||participants|||Number
168300|NCT00150345|Primary|Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis|Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion [fever, body temperature <36 or >38 degrees Celsius, graft-versus-host disease, use of corticosteroids]; and 1 microbiological criterion [fungal or yeasts]; or clinical criteria [abnormal site consistent with infection]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.|Day 2 through Day 28|Modified Intent-to-Treat population (MITT): participants in ITT population (at least 1 dose of study treatment) with valid post-baseline proven or probable IFI, did not have fungemia or other IFI at screening or randomization, no antipyretic analgesics on Day 5 (or Day 9 of open-label voriconazole). N=number of complete case evaluable participants.||participants|||Number
168301|NCT00150176|Secondary|Time to Early Discontinuation for Any Reason|The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).|time of discontinuation up to Day 182 (double blind phase)|Intent to treat (ITT) population, additionally excluding subjects not treated and excluding subjects with past enrollment in an asenapine trial.||participants|||Number
168302|NCT00150176|Primary|Time to Relapse or an Impending Relapse|"A relapse or impending relapse was declared if a subject meets 1 of 3 symptomatic relapse criteria which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary."|time of first relapse up to Day 182 (double blind phase)|ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed & subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing >3 days after last dose also excluded.||relapses|||Number
168303|NCT00149994|Primary|Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation.|A BPAR is defined when the investigator had a suspicion of an acute rejection, where the final clinical diagnosis confirmed the occurrence of an acute rejection, where a biopsy was performed that confirmed the presence of an acute rejection, and where anti-rejection treatment intervention was initiated. The efficacy measured the first rejections (clinically and biopsy proven rejections) at 3 months.|Month 3|Intention to treat (ITT) population.||Percentage of Participants|||Number
168304|NCT00149890|Secondary|Percentage of Participants With Treatment Failure Within Three and Six Months|To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months.|3 and 6 months|Intention to treat population||Percentage of participants||95% Confidence Interval|Number
168305|NCT00149890|Secondary|Time of Onset of a First Biopsy Proven Acute Rejection|Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension|6 months|safety/Intent to Treat (ITT) population||Months||95% Confidence Interval|Median
168306|NCT00149890|Secondary|Number of Participants With Bacterial, Viral and Fungal Infections During Six Months|To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months.|6 months|Safety Population||Participants|||Number
168309|NCT00149890|Secondary|Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months|At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension.|3 months|safety/Intent to Treat (ITT) population||Participants|||Number
168310|NCT00149890|Primary|Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation|Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.|3 months after treatment|safety/Intent to Treat (ITT) population||Participants|||Number
168311|NCT00149825|Secondary|Remission of Insomnia|Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.|After 12 weeks or at the last available time point|Included in the analysis were all participants who attended at least one post randomization visit.||percent|||Number
168312|NCT00149825|Primary|Remission of Depression (%)|"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.~The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.~The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains)."|After 12 weeks or at the last available time point|||percent of participants|||Number
168313|NCT00149799|Secondary|Depressive Symptoms (as Measured by the HAM-D)||Measured biweekly for six months after randomization||||||
168314|NCT00149799|Secondary|Psychosocial Functioning (as Measured by the LIFE-RIFT)||Measured four times throughout study (Weeks 0, 14, 28, and 40)||||||
168315|NCT00149799|Secondary|Q-LES-Q Short Form||Measured four times throughout study (Weeks 0, 14, 28, and 40)||||||
168316|NCT00149799|Secondary|Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)|We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.|Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14|||percentage of subjects who responded|||Number
168317|NCT00149799|Primary|Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)|We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.|Phase II: Biweekly for six months after randomization|Intent-to-treat analysis of all 58 patients randomized to Phase II.||percentage of subjects who relapsed|||Number
168318|NCT00149747|Secondary|Peak Exercise Oxygen Consumption|Peak oxygen consumption measured during symptom limited treadmill exercise stress test|12 months|||mL of 02 per Kg per minute||Standard Deviation|Mean
168319|NCT00149747|Secondary|Sleep Disturbances|"Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance.~All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances."|12 months|Intent to treat||units on a scale||Standard Deviation|Mean
168320|NCT00149747|Primary|% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline|Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).|baseline, 12 months|Intent to Treat||percentage of sleep time||Standard Deviation|Mean
168321|NCT00149643|Secondary|Number of Cannabis Use Disorder Criterion Met at a Particular Time Point.|Criterion used in this study was the number of DSM-IV cannabis use disorder symptoms (criteria) that were met.|12 Weeks|||Number of DSM-IV criterion||Standard Deviation|Mean
168322|NCT00149643|Primary|Depression Symptoms at Week 12|Average of Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10 and 12. The BDI is a subject reported measure that has a minimim score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scare (63). Each DSM-IV criteron asses a different depressive symptom.|12 Weeks|||BDI Total||Standard Deviation|Mean
168323|NCT00149643|Primary|Days Per Week of Cannabis Use.|The number days out of the last seven days that cannabis was used.|12 Weeks|||Days of cannabis use per week||Standard Deviation|Mean
168324|NCT00149630|Secondary|Retention by Treatment Condition.|Treatment retention for full 12 weeks of study.|12 weeks|74 cocaine and opioid-codependent(DSM-V)subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250 mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduced DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.||% of subjects who complete 12 wks study|||Number
168325|NCT00149630|Primary|Urine Toxicology for Cocaine.||Thrice weekly, baseline through week 14.|74 cocaine and opioid-codependent (DSM-V) subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduces DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.||% cocaine + urines over 2 week blocks||Standard Error|Mean
168326|NCT00149227|Secondary|Uncontrolled Blood Pressure, Etc.||five years||||||
168353|NCT00148798|Secondary|Disease Control Rate|The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT||percentage of participants||95% Confidence Interval|Number
168710|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12|||L||Standard Error|Mean
168327|NCT00149227|Secondary|New Onset or Worsening of Diabetes Mellitus or IGT|"Diabetes mellitus was defined as fasting plasma glucose >=126 mg/dl, causal blood glucose >= 200 mg /dl, HbA1C >= 6.5%, and/or plasma glucose 2hr after 75g glucose load >= 200 mg/dl. The first of these events, new onset diabetes or worsening diabetes following IGT, occurring in a specific patient was classified as an event to be counted in the secondary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years|||event number|||Number
168328|NCT00149227|Secondary|New Onset or Worsening of Arrhythmias||five years||||||
168329|NCT00149227|Secondary|Worsening of Cardiac Function||five years||||||
168330|NCT00149227|Secondary|All Cause Mortality||five years|||patients|||Number
168331|NCT00149227|Primary|Transition to Dialysis, Doubling of Plasma Cr Levels|"The first of any events, transition to dialysis or doubling of plasma Cr levels compared to the entry, occurring in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level."|five years|||event number|||Number
168332|NCT00149227|Primary|New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans|Arteriosclerosis obliterans (ASO) event was diagnosed with symptoms and CT / MRI imaging. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
168333|NCT00149227|Primary|New Onset of Acute Dissecting Aneurysm of the Aorta|Dissecting aneurysm of the aorta required hospitalization and was diagnosed by imaging technique, CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
168334|NCT00149227|Primary|Operation of PCI or Bypass Operation||five years||||||
168335|NCT00149227|Primary|Hospitalization Due to the New Onset, Occurrence or Worsening of Angina Pectoris and Additional Concomitant Use of Other Anti-anginal Agents or Increase of Dosage|Angina pectoris event required hospitalization and was diagnosed by both ECG changes corresponding with chest symptoms and coronary angiography showing 75% stenosis according to AHA/ACC guidelines. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
168336|NCT00149227|Primary|Hospitalization Due to the New Onset, Recurrence or Worsening of Heart Failure and Additional Concomitant Use of Other Anti-heart Failure Agents or Increase of Dosage|Heart failure event was defined as requiring hospitalization and clinical symptoms together with left ventricular dysfunction by echocardiography according to the guidelines of the AHA/ACC. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
168337|NCT00149227|Primary|New Onset or Recurrence of Acute Myocardial Infarction|Acute myocardial infarction was diagnosed with hospitalization, ECG- change, and biomarkers for myocardial infarction. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
168338|NCT00149227|Primary|New Onset or Recurrence of Transient Ischemic Attack|Transient ischemic attack (TIA) was defined as hospitalization with sudden onset of neurological deficit persisting for less than 24 hrs, and without abnormal findings using by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|||event number|||Number
168339|NCT00149227|Primary|New Onset or Recurrence of Stroke|Stroke events included brain hemorrhage, infarction, and TIA. They required hospitalization with neurological symptoms and were diagnosed by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.|five years|Analyses were made by the independent Statistical Analysis Organization based on the intention-to-treat principle.||event number|||Number
168374|NCT00148109|Secondary|Progression Free Survival.|Time of cetuximab administration to clinically documented progression of disease or death assessed for four months|survival|||months||95% Confidence Interval|Median
168340|NCT00149214|Secondary|Disease-free Survival|Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.|baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)|All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored.||months||95% Confidence Interval|Median
168341|NCT00149214|Secondary|Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery|Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy~Specimen for evaluation of pathological response obtained upon surgery~Treatment with at least one dose of study drug of the assigned study regimen."||participants|||Number
168342|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.|Cycles 5-8 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy up to surgery~Presence of measurable disease as defined by RECIST.~Treatment with at least one dose of study drug of assigned study regimen."||participants|||Number
168343|NCT00149214|Secondary|Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy|The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.|Cycles 1-4 (21-day cycles)|"Participants meeting following criteria qualify for clinical tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy up to surgery~Presence of measurable disease as defined by RECIST.~Treatment with at least one dose of study drug of assigned study regimen."||participants|||Number
168344|NCT00149214|Primary|Number of Participants With a Pathological Complete Response|pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy|surgery after eight 21-day cycles of chemotherapy|"Participants meeting the following criteria qualify for pathological tumor response:~Histologic diagnosis of primary operable breast cancer~No concurrent antitumor therapy~Specimen for evaluation of pathological response obtained upon surgery~Treatment with at least one dose of study drug of the assigned study regimen."||participants|||Number
168345|NCT00148954|Secondary|Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode||Time of event||||||
168346|NCT00148954|Secondary|Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)||Time of event||||||
168347|NCT00148954|Secondary|Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)||Time of event||||||
168348|NCT00148954|Primary|Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit|An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.|From date of pre-discharge until a minimum of 12 months follow-up until study closure|||Participants|||Number
168349|NCT00148798|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|Safety Population||participants|||Number
168350|NCT00148798|Secondary|A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations|Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.|Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.|||ug/mL||Standard Deviation|Mean
168351|NCT00148798|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 280/275; cycle 3 185/153; 6 month 101/97||scores on a scale||Standard Error|Least Squares Mean
168352|NCT00148798|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96||scores on a scale||Standard Error|Least Squares Mean
168354|NCT00148798|Secondary|Best Overall Response Rate|The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|||percentage of participants||95% Confidence Interval|Number
168355|NCT00148798|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT||months||95% Confidence Interval|Median
168356|NCT00148798|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007|ITT||months||95% Confidence Interval|Median
168357|NCT00148759|Primary|24-hr LPV AUC|Steady state(2 weeks after therapy change)|24 hours|||ng*hr/mL||Inter-Quartile Range|Geometric Mean
168358|NCT00148759|Secondary|24-hr LPV Cmax|LPV Cmax at Steady State|24 hours|||ng/mL||Inter-Quartile Range|Geometric Mean
168359|NCT00148733|Secondary|Folate, Cobalamin and Vitamin D Status of the Enrolled Children|And whether or not these vitamins predict treatment failure and duration of illness.|14 days||10/2016||||
168360|NCT00148733|Secondary|Will Presence of a RNA Virus Modify the Effect of Zinc|We will compare the efficacy of zinc according to virus detected in nasopharyngeal secretions|14 days||10/2016||||
168361|NCT00148733|Secondary|The Efficacy of Zinc in Malnourished and Non-malnourished Children|We will compare the efficacy of zinc in those that are stunted, wasted or underweight with those who are not.|Within 2 weeks after enrollment||10/2016||||
168362|NCT00148733|Secondary|The Efficacy of Zinc According to Breast Feeding Status and in Different Age Categories|We will measure to what extent breastfeeding status modifies the effect of zinc on pneumonia|Within 2 weeks after enrollment||10/2016||||
168363|NCT00148733|Secondary|Effect Modifiers for the Effect of Zinc Given During Pneumonia|We will also measure of there are factors at baseline that modifies the effect of zinc. Whether the following are modifiers for the above-mentioned effect of zinc given during pneumonia: i.severe inflammation, reflected in: high fever and/or elevated plasma C-reactive protein (CRP) concentration|Within 2 weeks after enrollment||10/2016||||
168364|NCT00148733|Primary|Adverse Effects|Vomiting, regurgitation, pain in abdomen for 15 minutes after zinc or placebo administration.|14 days||10/2016||||
168365|NCT00148733|Primary|Difference in Growth and Thymic Size Between the Treatment Groups Measured at Three and Six Months After the Zinc Supplementation|Thymus size will be measured using ultrasonography and compared between the two groups. at two occasions 2.5 and 6 months after end of supplementation|six months||10/2016||||
168366|NCT00148733|Primary|Active and Passive Morbidity Surveillance for Six Months After the 14-day Supplementation Period is Completed|We will measure to what extent short term zinc administration has an impact on growth and morbidity for up to 6 months after end of supplementation|six months||10/2016||||
168367|NCT00148733|Primary|Non-injury Clinic Visits and Hospital Admissions After Treatment Has Been Initiated|We will measure to what extent the intervention can reduce the number of severe events.|Within 2 weeks after enrollment||10/2016||||
168368|NCT00148733|Primary|Risk of Treatment Failure.|Enrolled children will be followed and given zinc or placebo for 14 days. We will compare the proportion with treatment failure (i.e. lack of improvement within 3 days) between the two groups|Within 2 weeks after enrollment|||participants|||Number
168369|NCT00148668|Primary|Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer|Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery|12 weeks|Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable.||percentage of participants|||Number
168370|NCT00148122|Secondary|Probability of Progression Free Survival|The estimated 1 year progression free survival. Progression was defined, using RECIST (Response Evaluation Criteria In Solid Tumors Criteria), as a 20% increase in the sum of the longest diameter of target lesions, the development of any new lesion, or the significant clinical deterioration related to the progression of patient's disease. The probability of progression-free survival was presented in a Kaplan-Meier curve to illustrate the distribution of progression time. The median time to progression was determined with a 95% CI (Confidence Interval).|1 year post treatment|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.||percentage of patients||95% Confidence Interval|Number
168371|NCT00148122|Secondary|Frequency of Grade III/IV Toxicities Experienced by Participants|The frequency of grade 3 and grade 4 adverse events experienced by all treated participants.|30 days post treatment|40 patients were enrolled. 2 patients withdrew consent, therefore only 38 were included in the toxicity analysis.||participants|||Number
168372|NCT00148122|Primary|Overall Response Rate at 4 Months|Disease was assessed by radiologic imaging and RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|4 months|40 patients were enrolled. 2 patients withdrew consent and 2 patients were not evaluable per protocol criteria: A patient will be considered evaluable for response if they received at least 2 cycles of chemotherapy, OR if they have obvious clinical signs of disease progression on physical examination after one cycle of chemotherapy.||percentage of participants|||Number
168373|NCT00148109|Secondary|Overall Survival|Time of cetuximab administration to clinically documented death assessed for four months|months|||months||95% Confidence Interval|Median
168376|NCT00147966|Primary|American College of Rheumatology (ACR) 20 at Week 12|ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).|0 and 12 weeks|||participants|||Number
168377|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Weeks|Bone trabeculation through the bone lesion compared at 6 weeks were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
168378|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Weeks|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 weeks. Participants were seen 6 week follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 weeks|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
168379|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 3 Months|Bone trabeculation through the bone lesion compared at 3 months were reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
168380|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 3 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 3 months. Participants were seen 3 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|3 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
168381|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 6 Months|Bone trabeculation through the bone lesion at 6 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
168382|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 6 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 6 months. Participants were seen 6 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|6 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
168383|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 12 Months|Bone trabeculation through the bone lesion at 12 months was reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
168384|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 12 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 12months. Participants were seen 12 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|12 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
168385|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 18 Months|Bone trabeculation through the bone lesion at 18 months with reviewed with radiographs. There were several participants with incomplete follow up or incomplete radiographs.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of trabeculation||Full Range|Mean
168386|NCT00147823|Other Pre-specified|Resorption of Graft Material (GR) Compared at 18 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation at 18 months. Participants were seen 18 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|18 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this time point.||percentage of resorption||Full Range|Mean
168387|NCT00147823|Other Pre-specified|Bone Trabeculation Through the Defect (BT) Compared at 24 Months|Bone trabeculation through the bone lesion at 24 months as determined with radiographs. There were several participants with incomplete follow up or incomplete radiographs. .|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs at this time point.||percentage of trabeculation||Full Range|Mean
168388|NCT00147823|Primary|Resorption of Graft Material (GR) Compared at 24 Months|Percentage of graft material that is resorbed (disappears) from area of incorporation, at 24 months .Participants were seen 24 month follow with radiographs to review resorption of graft material. There a several that had incomplete follow up or radiographs not taken.|24 months|Number of participants analyzed, refers to the number of participants who completed follow up or had radiographs taken at this timepoint.||percentage of resorption||Full Range|Mean
168389|NCT00147745|Primary|Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose|Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect.|Baseline (Day -4) to first dose (Day 1)|The entire study population was included in this analysis||mg*hr/dL||Standard Deviation|Mean
168592|NCT00145574|Secondary|Percent Change in Apolipoprotein B From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein B from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168390|NCT00147745|Secondary|Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks|The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control.|Baseline to 12 weeks|"One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.~The least squares mean is adjusted for baseline values. This corrects for differences in baseline values between treatment groups."||percent||Standard Error|Least Squares Mean
168391|NCT00147745|Secondary|The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks|The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption.|Baseline to 12 weeks|One participant in the colesevelam 3.8g group discontinued. Therefore, 15 participants were included in this analysis.||mg*hr/dL||Standard Error|Least Squares Mean
168392|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12.|The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.||mg/kg/min||Standard Error|Least Squares Mean
168393|NCT00147745|Primary|Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment.|The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin.|Baseline to 12 weeks|The population analyzed was all randomized subjects who received medication and had a baseline and at least 1 post-randomization assessment of an efficacy variable. One placebo participant did not have a valid post-randomization insulin clamp study. Therefore, the number included in the placebo group for this analysis was 13.||mg/kg/min||Standard Error|Least Squares Mean
168394|NCT00147537|Secondary|Duration of Response (DR) in Phase 2|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, duration of response was not analyzed.|||||
168395|NCT00147537|Secondary|Time to Progression (TTP) in Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|Due to the status of the program, time to progression was not was not analyzed.|||||
168396|NCT00147537|Secondary|Progression-Free Survival (PFS): Phase 2|Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from radiological image (where data meet the criteria for progressive disease [PD]).|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments.||months||90% Confidence Interval|Median
168397|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 2|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Cmax was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.|||||
168398|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 2|Concentration at 504 hours post dose|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|C504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.|||||
168399|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 2|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|AUC504 was not calculated for Cycle 4 in Phase 2 based on the status of the program and the limited value this further PK analyses would provide.|||||
168400|NCT00147537|Secondary|Clearance (CL) of CP-751,871 for Cycle 4 in Phase 2|Systemic clearance.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|Clearance (CL) were not calculated based on the status of the program and the limited value this further PK analyses would provide.|||||
168401|NCT00147537|Secondary|Apparent Volume of CP-751,871 Distribution (Vd) for Cycle 4 in Phase 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|Volume of distribution (Vd) was not calculated based on the status of the program and the limited value this further pharmacokinetic analyses would provide.|||||
168608|NCT00145509|Primary|Number of Participants Who Discontinued Because of an Adverse Event|Participants who discontinued study medication due to adverse events.|40 weeks|||participants|||Number
168711|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6|||L||Standard Error|Mean
168402|NCT00147537|Secondary|The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC-QLQ-C30/-LC13) in Phase 2|The QLQ-C30/-LC13 is a 43 item, self-administered questionnaire designed to assess health outcomes in clinical trials. In addition to global quality of life, the measure assesses 5 functional domains (physical, role, cognitive, emotional and social functioning) and specific symptoms (eg, nausea, pain). Each item is rated on a 1-4 scale with ‘1’ representing “not at all” and ‘4’ “very much”. Within domains, items are scored to obtain a total score with higher scores representative of poorer HRQoL. Scale score range: 0 to 100.|Day 1 pre-dose of Cycle 1, monthly prior to each cycle (up to 17 cycles, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for EORTC-QLQ-C30/-LC13 in phase 2.|||||
168403|NCT00147537|Secondary|M.D. Anderson Symptom Assessment Inventory (MDASI) in Phase 2|The MDASI is a 19-item questionnaire that assesses the severity of 13 symptoms over the past 24 hours, as well as how much the symptoms interfered with 6 areas of function (eg, walking, work, mood), when the symptom was “at its worst”. Each item is scored from 0 to 10, with ‘0’ indicating that the symptom was either not present or did not interfere with their activities, and ‘10’ indicating that the symptom was “as bad as you can imagine” or “interfered completely” with their life. Total average score range: 0 to 10.|Day 1 pre-dose of Cycle 1, weekly for Cycle 1 and 2, monthly prior to each subsequent cycle (Cycle 3 up to Cycle 17, each cycle was 21 day), and follow up (one year post last study dose)|Due to the status of the program, no participants were analyzed for MDASI in phase 2.|||||
168404|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 2|HAHA are indicators of immunogenicity to CP-751,871|Day 1 pre-infusion of each Cycle (each cycle was 21 day) up to Cycle 17 and 150 days after the last CP-751,871 infusion|All participants who received any of the study treatments. N=number of participants who were analyzed for HAHA||number of participants|||Number
168405|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 4 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is then end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
168406|NCT00147537|Secondary|Maximum Observed Plasma CP-751,871 Concentration (Cmax) for Cycle 1 in Phase 1b|Maximum Observed Plasma Concentration|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
168407|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871 (AUClast) for Cycle 4 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
168408|NCT00147537|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of CP-751,871(AUClast) for Cycle 1 in Phase 1b|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
168409|NCT00147537|Secondary|Accumulation of CP-751,871 Ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac) in Phase 1b|Accumulation ratio (Cycle 4 AUC504 / Cycle 1 AUC504) (Rac)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1). Cycle 4 pre-infusion, 1 and 24 hour and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4).|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||ratio||Standard Deviation|Mean
168410|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose(C504) for Cycle 4 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
168411|NCT00147537|Secondary|CP-751,871 Concentration at 504 Hours Post Dose (C504) for Cycle 1 (End of the 21-day Cycle) in Phase 1b|Concentration at 504 hours post dose|Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
168412|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 4 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||Day||Standard Deviation|Median
168413|NCT00147537|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 for Cycle 1 in Phase 1b|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||Day||Standard Deviation|Mean
168414|NCT00147537|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUCinf] for CP-751,871 for Cycle 1 in Phase 1b|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
168415|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 4 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg.hr/L||Standard Deviation|Mean
168416|NCT00147537|Secondary|Area Under the Curve From Time Zero to 504 Hours [AUC (0-504)] Post Infusion of CP-751,871 for Cycle 1 in Phase 1b|AUC (0-504)= Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the 21-day cycle, 504 hours(0-504)|Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||milligram.hour/Liter (mg.hr/L)||Standard Deviation|Mean
168417|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 4 in Phase 1b||Cycle 4 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 5 pre-infusion (which is the end of Cycle 4)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||mg/L||Standard Deviation|Mean
168418|NCT00147537|Secondary|Plasma Concentration of CP-751,871 at the End of Infusion (Cendinf) for Cycle 1 in Phase 1b||Cycle 1 pre-infusion, 1 and 24 hours and 4 and 8 days post infusion, Cycle 2 pre-infusion (which is the end of Cycle 1)|All participants who received at least one dose of each agent. N=number of participants contributing to the summary statistics||milligram/liter (mg/L)||Standard Deviation|Mean
168419|NCT00147537|Secondary|Number of Circulating Tumor-Related Cells (CTCs) and CTC Insulin-Like Growth Factor 1 Receptor (IGF-IR) Expression: Phase 1b|Blood samples were collected to enumerate the number of total CTCs and CTC insulin-like growth factor 1 receptor (IGF-IR) expression|Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CTCs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.|||||
168420|NCT00147537|Secondary|Number of Circulating Endothelial Cells (CECs): Phase 1b||Day 1 pre-dose and Days 15 to 21 of Cycle 4|Per protocol amendment 6, blood samples for the rapid quantification of CECs were no longer collected from participants enrolled in the study. Insufficient data were available to evaluate for correlation.|||||
168421|NCT00147537|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Values: Phase 1b|HAHA are indicators of immunogenicity to CP-751,871.|Day 1 pre-infusion of each cycle up to Cycle 17 (each cycle was 21 day), 150 days after the last CP-751,871 infusion, and last follow up visit (one year post last study dose)|All participants who received at least one dose of any agent. N=number of participants who were analyzed for HAHA||number of participants|||Number
168422|NCT00147537|Secondary|Objective Response Rate: Phase 1b|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received at least one dose of any agent. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment||percentage of participants|||Number
168423|NCT00147537|Primary|Objective Response Rate in Non-Adenocarcinoma Participants: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment||percentage of participants||90% Confidence Interval|Number
168424|NCT00147537|Primary|Objective Response Rate: Phase 2|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Every 2 cycles (7 to 10 days prior to the planned start of the next cycle, each cycle was 21 days) from start of treatment until either death or a total of 2 years from the date of randomization|All participants who received any of the study treatments. N=number of participants who had measurable disease at baseline and an adequate baseline tumor assessment||percentage of participants||90% Confidence Interval|Number
168425|NCT00147537|Primary|Recommended Phase 2 Dose (RP2D): Phase 1b||Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.||mg/kg|||Number
168426|NCT00147537|Primary|Maximum Tolerated Dose (MTD)of CP-751,871 in Combination With Paclitaxel and Carboplatin: Phase 1b|The maximum tolerated dose of CP-751,871 in combination with paclitaxel and carboplatin is the highest dose level below the Maximum Administered Dose (the dose level at which 2 or more out of 3 to 6 patients experience a Dose Limiting Toxicity at a dose level in Cycle 1) at which none or one out of 6 patients experience a Cycle 1 Dose Limiting Toxicity.|Start of treatment (baseline) up to the end of Cycle 1 (Day 21)|All participants who received at least one dose of any agent.||mg/kg|||Number
168427|NCT00146328|Secondary|Change From Baseline in CD4 Cell Count (LOCF)|Change from baseline in CD4 cell count with last observation carried forward(LOCF).|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4,1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed.||cells/mm3||Standard Deviation|Mean
168609|NCT00145509|Primary|Number of Participants Who Experienced an Adverse Event|Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).|up to 52 weeks|||Participants|||Number
168428|NCT00146328|Secondary|Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)|Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with last observation carried forward (LOCF)|Baseline to 192-240 week time interval|FAS17 with last observation carried forward (LOCF, missing were replaced by the previous non-missing value), Group 1: TPV/r patients from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48; Group 2: Patients from 1182.51; Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and rolled into 1182.17||Log 10 copies/mL||Inter-Quartile Range|Median
168429|NCT00146328|Primary|Number of Patients With Adverse Events Leading to Death|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168430|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168431|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168432|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168433|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168434|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168435|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168436|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168437|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17||participants|||Number
168438|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168439|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168440|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168441|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168442|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168443|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168444|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168445|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168446|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168447|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168448|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168449|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168450|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168451|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168452|NCT00146328|Primary|Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin|NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|End of Trial (>288 weeks)|FAS17 - Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48 Group 2: Patients from 1182.51 who rolled over into 1182.17 Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.||participants|||Number
168462|NCT00147498|Secondary|Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
168453|NCT00147498|Secondary|Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)|Disease improvement was classified as good, moderate, and no change based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate improvement. Scores of good and moderate were considered to have therapeutic response.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||participants|||Number
168454|NCT00147498|Secondary|Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and <2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all participants who were randomized to study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable for a particular time-point for each treatment arm, respectively.||units on a scale||Standard Deviation|Mean
168455|NCT00147498|Secondary|Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score ranging 0 to 9.4; higher scores indicated greater affectation due to disease activity. DAS 28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Deviation|Mean
168456|NCT00147498|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
168457|NCT00147498|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mg/L||Standard Deviation|Mean
168458|NCT00147498|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Mean
168459|NCT00147498|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||units on a scale||Standard Error|Mean
168460|NCT00147498|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
168461|NCT00147498|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
168506|NCT00147030|Secondary|Bayley Psychomotor Developmental Index Score (PDI)|Bayley Psychomotor Developmental Index score (PDI) <70|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
168463|NCT00147498|Secondary|Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
168464|NCT00147498|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
168465|NCT00147498|Secondary|Patient Global Assessment (PtGA) of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 millimeter (mm) Visual Analog Scale (VAS) where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||mm||Standard Error|Mean
168466|NCT00147498|Secondary|Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Error|Mean
168467|NCT00147498|Secondary|Swollen Joints Count (SJC)|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||swollen joints||Standard Error|Mean
168468|NCT00147498|Secondary|Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Error|Mean
168469|NCT00147498|Secondary|Tender Joints Count (TJC)|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.|Baseline, Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||tender joints||Standard Error|Mean
168470|NCT00147498|Secondary|Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve|ACR-n: calculated by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant’s assessment of disease activity; participant’s global assessment of pain; physician’s assessment of disease activity; participant’s assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the AUC of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.|Baseline up to Week 6|FAS included all randomized participants who received at least 1 dose of study treatment. Here ‘N’ (Number of Participants Analyzed) signifies participants who were evaluable for this measure.||units on a scale*weeks||Standard Deviation|Mean
168471|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
168472|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, 6, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, 4, and 6. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
168549|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [6 Months]||6 months|||percent apoptosis||Standard Deviation|Mean
168550|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD8+ Cell Population [3 Months]||3 months|||percent apoptosis||Standard Deviation|Mean
168473|NCT00147498|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 2, 4, and 8|FAS included all randomized participants who received at least 1 dose of study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF) at Week 1, 2, and 4. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.||percentage of participants|||Number
168474|NCT00147498|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment.||percentage of participants|||Number
168475|NCT00147446|Secondary|No.of New or Enlarged T2 Lesions From Week 8 to Week 24|T2-weighted MRI is commonly used in phase II trials to identify more permanent lesions. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24|||participants|||Number
168476|NCT00147446|Primary|No.of Gd+ Lesions From Week 8 to Week 24|Gd+ is Gadolinium-enhancing MRI brain lesion, A marker of the opening of the blood-brain barrier and is typically used as a primary endpoints in phase II trials because of its high sensitivity to ongoing MS disease activity and its association with clinical exacerbation. The single value was calculated by summing up the lesions from week 8 to week 24.|week 8 to week 24|A total of 121 patients with relapsing forms of MS were randomized to SMT-MS or WLC. Participants were enrolled at MS specialty clinics at 3 sites in the United States (UCSF; Evergreen Hospital Medical Center, and the Feinberg School of Medicine at Northwestern University, Chicago, Illinois) and through local chapters of the National MS Society.||participants|||Number
168477|NCT00147316|Primary|Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours|The number of patients with sICH|within 36 hours|||participants|||Number
168478|NCT00147316|Primary|Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months|The number of patients with a mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.|at 3 months|||participants|||Number
168479|NCT00147290|Secondary|Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF||one year||||||
168480|NCT00147290|Secondary|Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT||one year||||||
168481|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT||one year||||||
168482|NCT00147290|Secondary|Compare Efficacy of the First BiV and RV ATP to Terminate FVT||one year||||||
168483|NCT00147290|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with GEE method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year|||Percent of VT episodes terminated|||Number
168484|NCT00147277|Secondary|Evaluate Different Possible Predictors of ATP Success||one year||||||
168485|NCT00147277|Secondary|Compare Likelihood of Syncopal Events Associated With FVT||one year||||||
168486|NCT00147277|Secondary|Percent Reduction in Shocks Delivered Per Patient for Treating FVT||one year||||||
168487|NCT00147277|Secondary|Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms||one year||||||
168488|NCT00147277|Secondary|Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention||one year||||||
168489|NCT00147277|Primary|Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)|Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.|one year|934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method.||Percentage of FVT episodes terminated|||Number
168490|NCT00147238|Primary|Sensitivity of MRI Per Patient|Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).|MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI|Primary outcome measure was not assessed due to early study termination (e.g. patients did not receive assigned treatment).|||||
168491|NCT00147225|Primary|Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.||participants|||Number
168551|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [6 Months]||6 months|||percent apoptosis||Standard Deviation|Mean
168492|NCT00147225|Primary|Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy|Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.|Toxicity assessments with each dose level/cycle (21-28 day cycle) up to 6 cycles|All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.||participants|||Number
168493|NCT00147212|Primary|The Number of Men With Advanced Prostate Cancer Treated With Trabectedin Who Have a PSA Response|Prostate specific antigen (PSA) response rate, as defined by the PSA Working Group Criteria (see Bubley et al, J Clin Oncol. 1999 Nov;17(11):3461-7)|Participants were followed until disease progression, an average of 6 months|Intent to treat||participants|||Number
168494|NCT00147199|Secondary|N-terminal Pro-B-Type Natriuretic Peptide (NT Pro-BNP)|Change in NT pro-BNP from Baseline to Week 12. Plasma samples were collected from patients at Baseline and Week 12 in order to measure any change over time in circulating plasma levels of this biomarker.|12 weeks|Per protocol||pg/mL||Inter-Quartile Range|Median
168495|NCT00147199|Secondary|Change in Signs and Symptoms of PAH|Signs and symptoms of PAH (Loud P2 sound, Ascites, Right ventricular S3 sound, Dyspnea, Right ventricular S4 sound, Orthopnea, Right ventricular heave, Dizziness, Murmur of tricuspid insufficiency, Syncope, Murmur of pulmonic insufficiency, Chest pain, Hepatomegaly, Palpitations, Jugular venous distension at 45 degrees, Fatigue, Edema) were assessed at Baseline and Week 12. The status of each sign and symptom (“absent” or “present”) was assessed at each visit. To assess overall change from baseline in signs and symptoms, a “1” was assigned for each sign and symptom that was “present” at the Week 12 but was “absent” at baseline, a “-1” was assigned for each sign and symptom that was “absent” at Week 12 but was “present” at baseline, and a “0” was assigned for no change. An overall change score at each post-baseline assessment was then calculated by summing these values for all signs and symptoms. The overall change score had the potential to range from -17 to 17.|12 weeks|Intention to treat population.||units on a scale||Full Range|Median
168496|NCT00147199|Secondary|Quality of Life (Minnesota Living With Heart Failure)|Quality of life as measured by the Minnesota Living With Heart Failure (MLWHF) questionnaire was evaluated at baseline and at Week 12. The MLWHF questionnaire consists of 21 questions assessing how the patient’s heart failure has prevented them from living the way they wanted during the defined time period. Each question was graded by the patient with a numeric value between 0 (No/none) and 5 (very much). These scores were then summed across the 21 questions for a Global Score. Global scores ranged from 0 to 105. These questions were further grouped into Physical (8 of the questions) and Emotional (5 of the questions) dimensions to further characterize the effect of heart failure on the patient’s life. Physical scores ranged from 0 to 40, and emotional scores ranged from 0 to 25. For all 3 categories, the lower the score, the better the outcome. Values presented as change from Baseline.|12 weeks|Intention to treat population.||units on a scale||Inter-Quartile Range|Median
168497|NCT00147199|Secondary|Peak 6MWD at Week 6|Change in peak 6MWD between Baseline and Week 6.|6 weeks|Intention to treat||meters||Inter-Quartile Range|Median
168498|NCT00147199|Secondary|Trough 6MWD at Week 12|Change in 6MWD from Baseline to trough 6MWD at Week 12. Trough was defined as a 6MWT conducted at least 4 hours following study drug inhalation.|12 Weeks|Intention to treat population||meters||Inter-Quartile Range|Median
168499|NCT00147199|Secondary|New York Heart Association (NYHA) Functional Classification|"Change in NYHA functional class at Week 12. NYHA classifications:~Class I – Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope.~Class II – Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III – Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class IV – Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|12 weeks|Intention to treat population||participants|||Number
168500|NCT00147199|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a patient reported number between 0 (no perceived shortness of breath) and 10 (maximum perceived shortness of breath), obtained at the completion of each 6MWT.|12 weeks|Intention to treat population. A Week 12 observation was not present for one subject and that data point is not included in the analysis.||score||Standard Deviation|Mean
168501|NCT00147199|Secondary|Clinical Worsening Events|Clinical worsening was defined as the first incidence of clinical worsening from randomization to the first occurrence of death, transplantation, hospitalization for PAH, or initiation of additional approved PAH therapy.|12 weeks|Intention to treat population||clinical worsening events|||Number
168502|NCT00147199|Primary|Peak 6-minute Walk Distance|Change in peak 6-minute walk distance from baseline to Week 12. Peak 6MWD was defined as a 6-minute walk test (6MWT) within 10 to 60 minutes after study drug inhalation|12 weeks|Intention to treat analysis||meters||Inter-Quartile Range|Median
168503|NCT00147030|Secondary|Microcephaly|Head circumference at follow-up >2 standard deviations below the mean|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
168504|NCT00147030|Secondary|Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment)||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
168505|NCT00147030|Secondary|Sensorineural Hearing Loss|Normal or near normal hearing, no sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
168507|NCT00147030|Secondary|Multiple Handicap|defined as the presence of any two of the following in an infant; neuromotor disability (Level 3-5 on Gross Motor Function classification), mental delay (Bayley Mental Developmental Index (MDI) score < 70), epilepsy, cortical visual impairment, sensorineural hearing loss|18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
168508|NCT00147030|Secondary|Severe Neurodevelopmental Disability||18 months|Number of participants analyzed is reduced due to deaths prior to assessment and not all survivors could complete all elements of the examination. Number analyzed represents the participants on whom the relevant data for this outcome could be documented.||participants|||Number
168509|NCT00147030|Secondary|Mortality||18 months|||participants|||Number
168510|NCT00147030|Secondary|Duration of Hospitalisation|Total duration of hospital care|Duration of hospital stay, on average 22 days|||days||Inter-Quartile Range|Median
168511|NCT00147030|Secondary|Pulmonary Airleak||Duration of hospital stay, on average 22 days|||participants|||Number
168512|NCT00147030|Secondary|Pneumonia||Before discharge from hospital|||participants|||Number
168513|NCT00147030|Secondary|Renal Failure Treated With Dialysis||Duration of hospital stay, on average 22 days|||participants|||Number
168514|NCT00147030|Secondary|Major Venous Thrombosis||Duration of hospital stay, on average 22 days|||participants|||Number
168515|NCT00147030|Secondary|Thrombocytopenia||Duration of hospital stay, on average 22 days|||participants|||Number
168516|NCT00147030|Secondary|Cardiac Arrhythmia|Arrhythmia identified on electrocardiogram (ECG), e.g. sinus bradycardia <80 beats per minute, ventricular arrhythmia.|Duration of hospital stay, on average 22 days|||participants|||Number
168517|NCT00147030|Secondary|Necrotising Enterocolitis||Duration of hospital stay, on average 22 days|||participants|||Number
168518|NCT00147030|Secondary|Culture Proven Sepsis||Duration of hospital stay, on average 22 days|||participants|||Number
168519|NCT00147030|Secondary|Prolonged Blood Coagulation Time||Duration of hospital stay, on average 22 days|||participants|||Number
168520|NCT00147030|Secondary|Pulmonary Hypertension||Duration of hospital stay, on average 22 days|||participants|||Number
168521|NCT00147030|Secondary|Pulmonary Haemorrhage||Duration of hospital stay, on average 22 days|||participants|||Number
168522|NCT00147030|Secondary|Persistent Hypotension|Hypotension was defined as a mean blood pressure of 40 mm Hg or less and was persistent if causes of hypotension had been sought and appropriate treatment provided, without success.|Duration of hospital stay, on average 22 days|||participants|||Number
168523|NCT00147030|Secondary|Intracranial Haemorrhage|Intracranial hemorrhage was identified on magnetic resonance imaging (MRI).|Duration of hospital stay, on average 22 days|||participants|||Number
168524|NCT00147030|Primary|Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors|Severe neurodevelopmental disability was defined as a score of less than 70 on the Mental Developmental Index of the Bayley Scales of Infant Development II (BSID-II) (on which the standardization mean [± standard deviation (SD)] is 100±15 and higher scores indicate better performance), a score of 3 to 5 on the Gross Motor Function Classification System (GMFCS) (on which scores can range from 1 to 5, with higher scores indicating greater impairment), or bilateral cortical visual impairment with no useful vision.|18 months|||participants|||Number
168525|NCT00146848|Secondary|Change in Self Assessed Physical Activity|Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.|From randomization (6-weeks) through 12-month visit|Physical activity was assessed using the Physical Activity Scale for the Elderly and was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups. Postive values for changes denote improvements.||units on a scale||Standard Deviation|Mean
168526|NCT00146848|Primary|Clinical Composite Score|The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.|From randomization (6-weeks) through 12-month visit|This analysis is intention to treat (ITT) in terms of patient's being analyzed according to their randomized group. Last observation carried forward (LOCF) method was used for missing NYHA and global assessment measures at 12 months.||participants|||Number
168527|NCT00146848|Secondary|Change in Quality of Life|Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.|From randomization (6-weeks) through 12-month visit|Quality of Life was analyzed for those patients with paired data available at the 6 week and 12 month visit. Patients were analyzed in their randomized groups.||units on a scale||Standard Deviation|Mean
168528|NCT00146770|Other Pre-specified|Change From Baseline to Week 182 in Urinary GAG Level|Urinary Glycosaminoglycan (GAG) Levels: >> Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||ug GAG/mg Creatinine||Standard Deviation|Mean
168529|NCT00146770|Secondary|Change From Baseline to Week 182 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one’s arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Degrees||Standard Deviation|Mean
168552|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [6 Months]||6 months|||percent apoptosis||Standard Deviation|Mean
168530|NCT00146770|Secondary|Change From Baseline to Week 182 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Units on a scale||Standard Deviation|Mean
168531|NCT00146770|Secondary|Change From Baseline to Week 182 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Cubic centimeters (cm3)||Standard Deviation|Mean
168532|NCT00146770|Secondary|Change From Baseline to Week 182 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat.||Events per Hour||Standard Deviation|Mean
168533|NCT00146770|Primary|Change From Baseline to Week 182 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 182|The study enrolled patients who completed the Phase 3 double-blind study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.||Meters||Standard Deviation|Mean
168534|NCT00146770|Primary|Change From Baseline to Week 182 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity: the maximal exhaled breath volume following a maximal inhaled breath. Overall change from Baseline to Week 182 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 182|This study enrolled patients who completed the Phase 3 Double-Blind Study and wished to receive open-label treatment with Aldurazyme. The analysis method was intention to treat with last value carried forward.||percent predicted FVC||Standard Deviation|Mean
168535|NCT00146757|Other Pre-specified|Investigator’s Clinical Assessment at Week 52 Compared With Baseline|The Investigator’s impression of the patient’s overall clinical status at Week 52 compared with Baseline.|Baseline to 52 weeks|The analysis was intent-to-treat.||participants|||Number
168536|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Height|Change in Z-scores for standing height/lying-length-for-age from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Units on a scale||Standard Deviation|Mean
168537|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Left Ventricular Mass (LVM) Z-Score|Change in LVM Z-scores as measured by echocardiography from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Units on a scale||Standard Deviation|Mean
168538|NCT00146757|Other Pre-specified|Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline|Independent experts provided a global assessment for each sleep study visit as well as the degree of clinically meaningful change over the course of the study. Assessment was based on AHI, severity and frequency of oxygen desaturations and sleep quality.|Baseline to 52 weeks|The analysis was intent-to-treat.||participants|||Number
168539|NCT00146757|Other Pre-specified|Change From Baseline to Week 52 in Apnea/Hypopnea Index (AHI)|Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events per hour indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Events per hour||Standard Deviation|Mean
168540|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Liver Size (Hepatomegaly)|Percent change in extent of Liver Edge Below Right Costal Margin (BRCM) measured in centimeters from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Percentage of change||Standard Deviation|Mean
168541|NCT00146757|Other Pre-specified|Percent Change From Baseline to Week 52 in Urinary Glycosaminoglycan (uGAG) Level|Percentage change in the concentration of GAG relative to creatinine (ug GAG/mg creatinine) in urine from Baseline to Week 52; A greater decrease in percent change indicates a greater response.|Baseline to 52 weeks|The analysis was intent-to-treat.||Percentage of change||Standard Deviation|Mean
168542|NCT00146757|Primary|Pharmacokinetics - Volume of Distribution (Vz)|Vz is the volume that relates the amount of drug in the body after absorption is complete to the concentration of drug in the plasma.|52 weeks|The analysis was intent-to-treat.||liters/kilograms||Standard Deviation|Mean
168543|NCT00146757|Primary|Pharmacokinetics - Total Plasma Clearance (CL)|CL is volume of the body fluid cleared of the drug per unit of time.|52 weeks|The analysis was intent-to-treat.||(milliliters/minute)/kilograms||Standard Deviation|Mean
168544|NCT00146757|Primary|Pharmacokinetics - Elimination Half Life (t1/2)|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|52 weeks|The analysis was intent-to-treat.||hours||Standard Deviation|Mean
168545|NCT00146757|Primary|Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)|AUC∞ is a measure of the total exposure to a drug.|52 weeks|The analysis was intent-to-treat.||hours units/milliliters||Standard Deviation|Mean
168546|NCT00146757|Primary|Safety Evaluation|Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.|52 weeks|The number of participants was determined as adequate to assess the safety of Aldurazyme in young children with mucopolysaccharidosis I (MPS I). The analysis was intent-to-treat.||participants|||Number
168547|NCT00145795|Secondary|Rates of Virologic Failure|Virologic failure defined as HIV RNA > 2,000 copies/mL|6 months|||percentage of randomized subjects|||Number
168548|NCT00145795|Secondary|Clinical HIV-related Events|"Number of participants experiencing clinical HIV-related events as defined by category A, category B, and Appendix B in the 1993 Revised Classification System for HIV Infection and Expanded Surveillance Case Definition for AIDS Among Adolescents and Adults (http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm)."|6 months|||number of participants with event(s)|||Number
168553|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ naïve Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months|||percent apoptosis||Standard Deviation|Mean
168554|NCT00145795|Secondary|Rates of ex Vivo T Cell Apoptosis: CD4+ Memory Cell Population [3 Months]|Ex vivo T cell apoptosis can be assessed many different ways. The use of propidium iodide staining to determine the proportion of isolated cells that have undergone apoptosis after ex vivo incubation is a standard method that has been used by many investigators. Apoptotic cells intercalate less PI into their DNA, and on flow cytometry, this cell population is identified by a decrease in mean fluorescence (shift to the left). We have experience with this assay, and we have published on the use of method for determining rates of ex vivo apoptosis for different immune effector cells.|3 months|||percent apoptosis||Standard Deviation|Mean
168555|NCT00145795|Primary|Immune Reconstitution [6 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 6 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|6 months|||cells per cubic millimeter||Standard Deviation|Mean
168556|NCT00145795|Primary|Immune Reconstitution [3 Months]|Immune reconstitution is defined as the absolute CD4+ lymphocyte count after 3 months of therapy. Absolute CD4+ T cell count, our measure of immune recovery, was assessed in the clinical laboratory using fluorescent labeled monoclonal antibodies to the CD4 on lymphocytes. This is the main target cell for HIV infection. The absolute CD4+ T cell count is also the only clinically validated surrogate marker of immune dysfunction in HIV. CD4+ count is also our best predictor of morbidity and mortality outcomes.|3 months|||cells per cubic millimeter||Standard Deviation|Mean
168557|NCT00145704|Primary|Change in Total Body Bone Mineral Density During an 18 Month Period|For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.|18 months|Data analyis halted, due to low enrollment,no outcomes to report|||||
168558|NCT00145626|Secondary|The Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation|The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately. Their effect on overall survival will be evaluated using logistic regression and Cox's proportional hazard model if there is censoring.|Baseline and up to 5 years after transplant||||||
168559|NCT00145626|Secondary|The Incidence of and Risk Factors for Long-term Neurocognitive Deficit.|The long-term neurocognitive deficit will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant||||||
168560|NCT00145626|Secondary|The Incidence of and Risk Factors for Organ Dysfunction.|The organ dysfunction will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.|Up to 5 Years after transplant||||||
168561|NCT00145626|Secondary|The Kinetics of Lymphohematopoietic Reconstitution.|The lymphohematopoietic reconstitution will be assessed in a longitudinal manner and analyzed accordingly.|Up to 5 years after transplant||||||
168562|NCT00145626|Secondary|Factors Affecting One-year Survival: Minimal Residual Disease (MRD)|Detection of leukemia blasts in bone marrow by flow cytometry|Up to one year after transplant|Only four of the 14 participants had MRD measured at the one-year time point.||participants|||Number
168563|NCT00145626|Secondary|Factors Affecting One-year Survival: Match N/6 HLA Loci|HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||participants|||Number
168564|NCT00145626|Secondary|Factors Affecting One-year Survival: Donor Type|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||participants|||Number
168565|NCT00145626|Secondary|Factors Affecting One-year Survival: Disease Status at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||participants|||Number
168566|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of NK Cells|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||NKcells X 10^6/kg||Full Range|Median
168567|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Dose of CD34|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||CD34 X 10^6/kg||Full Range|Median
168568|NCT00145626|Secondary|Factors Affecting One-year Survival: Median Age of Donor at HSCT|Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).|Up to one year after transplant|||Years||Full Range|Median
168570|NCT00145626|Secondary|Number of Transplant-related Adverse Outcomes|"Adverse outcomes include regimen-related mortality, engraftment failure, and fatal acute graft-versus-host-disease (GVHD).~The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice. The estimate of the incidence of engraftment failure and fatal acute GVHD will be obtained using Binomial distribution. Engraftment failure is defined as <10% donor cell chimerism at any time-point between 28–100 days after transplant with no evidence of disease relapse, or anyone requiring stem cell boost."|5 Years||||||
168571|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD)|The cumulative incidence estimate for occurrence of fatal acute GVHD by the end of the first 100 days post-transplant was calculated using method of Kalbfleisch and Prentice.|100 days post-transplantation|||Number of Deaths|||Number
168572|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Engraftment Failure|Engraftment failure is defined as <10% donor cell chimerism at any time point between 28 and 100 days after transplant with no evidence of disease relapse or requiring stem cell boost.|100 days post-transplantation|||proportion of engraftment failures||95% Confidence Interval|Number
168573|NCT00145626|Secondary|Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality|The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice.|100 days post-transplantation|||participants|||Number
168574|NCT00145626|Primary|One-year Survival|"The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system.~The Kaplan-Meier estimate for one-year survival is reported."|One year after transplant|||percentage of participants|||Number
168575|NCT00145600|Secondary|Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy PedsQL3 (composite) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168576|NCT00145600|Secondary|Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy communication quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168577|NCT00145600|Secondary|Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy perceived physical appearance quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168578|NCT00145600|Secondary|Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy cognitive problems (child + teen) quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168610|NCT00145496|Secondary|Change From Baseline in Body Weight||Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.||kg||Standard Error|Mean
168579|NCT00145600|Secondary|Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy worry quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168580|NCT00145600|Secondary|Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy treatment anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168581|NCT00145600|Secondary|Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy procedural anxiety quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168582|NCT00145600|Secondary|Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy nausea quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5)|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168583|NCT00145600|Secondary|Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy pain and hurt quality of life across multiple time points using the Peds Quality of Life version 3. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Of 296 eligible, 178 participated in QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy. Peds QL3 is not completed at T1 for newly diagnosed patients, because it measures symptoms over the prior month.||units on a scale||Standard Deviation|Mean
168584|NCT00145600|Secondary|Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy Peds QL4 (composite) quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
168712|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6||Month 6|||L||Standard Error|Mean
168585|NCT00145600|Secondary|Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy psychosocial quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
168586|NCT00145600|Secondary|Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy school quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
168587|NCT00145600|Secondary|Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy social quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
168588|NCT00145600|Secondary|Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy emotional quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
168589|NCT00145600|Secondary|Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.|Assess and compare the patient reported and parent proxy physical quality of life across multiple time points using the Peds Quality of Life version 4. Assessment was performed across all risk groups. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. The higher the score, the better the quality of life.|At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5).|Each participating institution made the decision to complete or not complete the QoL secondary aim. Of 296 eligible participants, 178 participated in the QoL assessment. For each time point, a matching participant and parent were required to evaluate each QoL question. We had some missing data and those over 18 years did not have parent proxy.||units on a scale||Standard Deviation|Mean
168590|NCT00145600|Primary|Event-free Survival Probability by Risk Group|Event-free survival (EFS) is based on the time from protocol enrollment to the occurrence of first event (relapse or progressive disease, subsequent malignancy, or death from any cause). Patients not experiencing an event are censored at their last follow-up date. Event-free Survival Probability will be estimated by Kaplan-Meier method with a 95% confidence interval.|Median 6.4 year follow-up|Nine patients were ineligible for analysis.||probability of 5 yr. event free survival||95% Confidence Interval|Number
168591|NCT00145587|Primary|Engraftment|To determine the need for blood or platelet transfusions and the presence of donor cells being present in the transplant recipient’s bone marrow or peripheral blood by 100 day after transplantation for children with malignant infantile osteopetrosis who have received a haploidentical stem cell graft.|100 days post-transplant|From September 2004 to March 2009, 5 consecutive MIOP patients were treated using mismatched family member donors. Favorable engraftment refers to the transplant patient not requiring blood or platelet transfusions and the presence of donor cells being present in the transplant recipient’s bone marrow or peripheral blood.||Participants|||Number
168713|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1|||L||Standard Error|Mean
168593|NCT00145574|Secondary|Percent Change in Apolipoprotein A-I From Study Baseline (Day 1) to Week 26.|Percent change in apolipoprotein A-I from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168594|NCT00145574|Secondary|Percent Change in Non-high-density Lipoprotein Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in non-high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168595|NCT00145574|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in high-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168596|NCT00145574|Secondary|Percent Change in Triglycerides From Study Baseline (Day 1) to Week 26.|Percent change in triglycerides from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168597|NCT00145574|Secondary|Percent Change in Total Cholesterol From Study Baseline (Day 1) to Week 26.|Percent change in total cholesterol (TC) from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent to treat population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168598|NCT00145574|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Study Baseline (Day 1) to Week 26.|Percent change in low-density lipoprotein cholesterol from baseline to Week 26 was calculated for subpopulations representing each assigned treatment group during the Double blind Period, and for the overall population in the Open Label Extension Period.|26 weeks (week 26 - day 1)|Intent-to-Treat (ITT) Population. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168599|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotein B (Apo B) From Day 1 (Study Baseline) to Week 8.|Percent change in Apo B (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168600|NCT00145574|Secondary|Percent Change in Plasma Apolipoprotien A-I (Apo A-1) From Day 1 (Study Baseline) to Week 8.|Percent change in Apolipoprotien A-I (Apo A-1) (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat (ITT) Population in Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168601|NCT00145574|Secondary|Percent Change in Plasma Non-high Density Lipoprotein-cholesterol (Non-HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in non-HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168602|NCT00145574|Secondary|Percent Change in Plasma High-density Lipoprotein-cholesterol (HDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in HDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168603|NCT00145574|Secondary|Percent Change in Plasma Triglycerides (TG) From Day 1 (Study Baseline) to Week 8.|Percent change in triglycerides (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168604|NCT00145574|Secondary|Percent Change in Plasma Total Cholesterol (TC) From Day 1 (Study Baseline) to Week 8.|Percent change in total cholesterol (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline) to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168605|NCT00145574|Primary|Percent Change in Plasma Low Density Lipoprotein-cholesterol (LDL-C) From Day 1 (Study Baseline) to Week 8.|Percent change in LDL-C (mg/dL) and standard deviation (SD) from Day 1 (Study Baseline)to Week 8 (last observation carried forward - LOCF)- Intent-to-Treat ITT population.|8 weeks (week 8 - day 1)|Intent-to-Treat Population for Double blind Period. Last Observation Carried Forward.||percent change from baseline||Standard Deviation|Mean
168606|NCT00145509|Primary|Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score|The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.||Score on a scale||Standard Deviation|Mean
168607|NCT00145509|Primary|Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score|The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.|Baseline and 52 Weeks|Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study.||Score on a Scale||Standard Deviation|Mean
168714|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1||Month 1|||L||Standard Error|Mean
168611|NCT00145496|Secondary|Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score|The Quality of Life Scale is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 to 126, with greater values indicating better quality of life.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.||Units on a Scale||Standard Error|Mean
168612|NCT00145496|Primary|Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score|The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.|Day 182|Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.||Units on a Scale||Standard Error|Mean
168613|NCT00145418|Secondary|Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.|Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.|day one of cycle one until participant removed from trial|all participants had adverse events||participants|||Number
168614|NCT00145418|Secondary|Duration of Response|Duration of response is a measure of how long the participants response to therapy was maintained.|0 -12 months|||months||Full Range|Median
168615|NCT00145418|Secondary|Time to Progression|Progression is measured from each participants start of study until removal from treatment.|<1 cycle to 6 cycles of treatment|||months||Full Range|Median
168616|NCT00145418|Primary|Response Rate|Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.|Response is measured every 2 cycles until disease progression|||Participants|||Number
168617|NCT00145327|Secondary|The Number of Participants With Clinically Significant Laboratory Parameters|Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||Participants|||Number
168618|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||μmol/L||Standard Deviation|Mean
168619|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||μmol/L||Standard Deviation|Mean
168620|NCT00145327|Secondary|Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion|Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.|Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion|Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.||μmol/L||Standard Deviation|Mean
168621|NCT00145327|Secondary|Qualitative Bone Biopsy Parameters|Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).|End of Study Visit at Year 6|Bone Biopsy sub-population.||Participants|||Number
168622|NCT00145327|Secondary|Number of Participants With Incidence of Clinical Fracture|Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.|Extension Baseline (Year 3; Month 36) to Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. n = the number of patients with measurements at Year 6 as determined by the analysis window.||Participants|||Number
168623|NCT00145327|Secondary|Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures|Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 as determined by the analysis window.||Percentage of patients|||Number
168635|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 42|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 42|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
168624|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
168625|NCT00145327|Secondary|Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
168626|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
168627|NCT00145327|Secondary|Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
168628|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 6 and Year 3 as determined by the analysis window.||Percentage change in BMD||Standard Error|Mean
168629|NCT00145327|Secondary|Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3|The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 and Year 3 as determined by the analysis window.||Percentage Change in BMD||Standard Error|Mean
168630|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 6: P1NP|The amount of serum P1NP as determined by the central laboratory|Year 6|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The Number of patients analyzed = the number of patients with measurements in Year 6 as determined by the analysis window.||ng/mL||Standard Error|Mean
168631|NCT00145327|Secondary|Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP|The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.|Year 4.5|Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 as determined by the analysis window.||ng/mL||Standard Error|Mean
168632|NCT00145327|Primary|Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3|The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 − femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).|Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)|Modified intent-to-treat (MITT) population. The MITT population included all patients in the ITT population who had DXA measurements of the femoral neck at Year 3 and Year 6. This was the primary population for primary efficacy parameter.||Percentage Change in BMD||Standard Error|Mean
168633|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 168|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 168|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
168634|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 70|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 70|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
168653|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Respiratory Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168636|NCT00145249|Secondary|Mean Change in Neurological Exam Score From Baseline - Day 14|Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.|Baseline and Day 14|The number of subjects tested in the modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm & receive any dose of study drug, who provide any outcome data, & who are determined to have met 2 key criteria for inclusion in the primary analysis: diagnosis of cryptococcal meningitis & HIV infection.||Scores on a scale||Standard Deviation|Mean
168637|NCT00145249|Secondary|Number of Cryptococcal Isolates With Antifungal Susceptibility|Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.|Days 14 and 70|The study team has since determined that the assay that was to be utilized did not have sufficient sensitivity/specificity for its intended purpose and therefore these results will not be generated.||Isolates|||Number
168638|NCT00145249|Secondary|Mean Days of Hospitalization|Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.|7, 14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.||Days||Standard Deviation|Mean
168639|NCT00145249|Secondary|Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)|"Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment.~Day = Day relative to first dose of study drug"|14, 42, and 70 days|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data||Subjects|||Number
168640|NCT00145249|Secondary|Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success|Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive|14, 42, and 70 days|The mITT population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.||Subjects|||Number
168641|NCT00145249|Secondary|Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points|Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.|Baseline, 14, 42, and 70 days|The modified Intent to Treat (mITT) population includes all subjects who are randomized to a treatment arm and receive any dose of study drug, who provide any outcome data, and who are determined to have met 2 key criteria for inclusion in the primary analysis - diagnosis of culture-proven cryptococcal meningitis and proven HIV infection.||Subjects|||Number
168642|NCT00145249|Secondary|Number of Deaths|"Number of deaths occurring on study.~Day = Day relative to the first dose of study drug."|14, 42, and 70 days|The Regulatory Safety Population was used in this analysis, which includes all subjects who were randomized, who received at least 1 dose of study drug, and who have any on-study data.||Subjects|||Number
168643|NCT00145249|Primary|Number of Dose-limiting Toxicities Attributed to Treatment Regimens|"Events are reported by MedDRA Preferred Term.~Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.||Events|||Number
168644|NCT00145249|Primary|Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug|"Events are reported by MedDRA Preferred Term.~Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention.~Grade 4 - Life-threatening. AE is life-threatening.~Grade 5 - Death. AE causes death."|Day 100|The Regulatory Safety population includes all subjects who were randomized, who receive at least 1 dose of study drug, and who have any on-study data.||Events|||Number
168645|NCT00145119|Primary|ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)|ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)|2 year|||participants|||Number
168646|NCT00145041|Primary|Volume of Distribution|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour|cycle 1 day 1|all patients enrolled||mL/m2||Standard Deviation|Mean
168647|NCT00145041|Primary|Clearance|The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2|Day 1 of Cycle 1|All subjects enrolled||ml/h/m2||Standard Deviation|Mean
168648|NCT00145041|Primary|T 1/2|The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.|cycle 1 day 1|all patients enrolled||hr||Standard Deviation|Mean
168649|NCT00144963|Primary|MTD of VSLI|Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.|6 weeks|This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.||mg/m2|||Number
168650|NCT00144781|Secondary|Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test: Distance walked (measured in Meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.||meters||95% Confidence Interval|Mean
168651|NCT00144781|Secondary|Percent Change From Baseline to Week 26 in Liver Organ Volume|A greater decrease in liver volume indicates a greater response.|Baseline to 26 Weeks|The analysis was intention to treat.||Percentage of Change in Liver Volume||95% Confidence Interval|Mean
168652|NCT00144781|Primary|Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Level|Urinary GAG Level - Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to 26 Weeks|Based on the changes in urinary GAG levels observed in the Phase 3 double-blind study, a sample size of 8 patients per group would have sufficient power to detect a 29 percentage point difference between groups in the mean change in urinary GAG levels as being statistically significant. The analysis was intention to treat.||Percentage of Change in GAG Level||95% Confidence Interval|Mean
168655|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Dyspnoea)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168656|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Chronic Obstructive Pulmonary Disease (COPD) Exacerbation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168657|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Bronchitis)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168658|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Lower Respiratory System Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168659|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Myocardial Infarction)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168660|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Coronary Artery Disease)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168661|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure Congestive)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168662|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Cardiac Failure)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168663|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Atrial Fibrillation)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168664|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (Preferred Term = Angina)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168665|NCT00144339|Other Pre-specified|Incidence Rate of Serious Adverse Event (System Organ Class = Cardiac Disorders)|Descriptive statistics show the number of patients with event, central tendency shows incidence rate. Incidence rate calculated as number of patients with event divided by at-risk years * 100.|Day 1 to completion of double blinded treatment plus 30 days|||Number of patients with event|||Number
168666|NCT00144339|Secondary|Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)|The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used|Day 1 to day 1470|||Participants|||Number
168667|NCT00144339|Secondary|Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)|The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days|||Participants|||Number
168668|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)|All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.|Day 1 to day 1470|||Participants|||Number
168669|NCT00144339|Post-Hoc|Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1440 Days)||Day 1 to day 1440|||Participants|||Number
168670|NCT00144339|Secondary|Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)|On-treatment defined as day 1 to completion of double blinded treatment plus 30 days|Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days|||Participants|||Number
168671|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 48|||Units on a scale||Standard Error|Mean
168672|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 42|||Units on a scale||Standard Error|Mean
168715|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48||Month 48|||L||Standard Error|Mean
168673|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 36|||Units on a scale||Standard Error|Mean
168674|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 30|||Units on a scale||Standard Error|Mean
168675|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 24|||Units on a scale||Standard Error|Mean
168676|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 18|||Units on a scale||Standard Error|Mean
168677|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 12|||Units on a scale||Standard Error|Mean
168678|NCT00144339|Secondary|Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6|"SGRQ total score summarizes the impact of COPD on overall patient's health status.~Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.~The scale is continuous.~Rate of decline shows the yearly change of SGRQ total score."|Month 6|||Units on a scale||Standard Error|Mean
168679|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48|||L||Standard Error|Mean
168680|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48||Month 48|||L||Standard Error|Mean
168681|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42|||L||Standard Error|Mean
168682|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42||Month 42|||L||Standard Error|Mean
168683|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36|||L||Standard Error|Mean
168684|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36||Month 36|||L||Standard Error|Mean
168685|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30|||L||Standard Error|Mean
168686|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30||Month 30|||L||Standard Error|Mean
168687|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24|||L||Standard Error|Mean
168688|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24||Month 24|||L||Standard Error|Mean
168689|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18|||L||Standard Error|Mean
168690|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18||Month 18|||L||Standard Error|Mean
168691|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12|||L||Standard Error|Mean
168692|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12||Month 12|||L||Standard Error|Mean
168693|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6|||L||Standard Error|Mean
168694|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6||Month 6|||L||Standard Error|Mean
168695|NCT00144339|Secondary|Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1|||L||Standard Error|Mean
168696|NCT00144339|Secondary|Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1||Month 1|||L||Standard Error|Mean
168697|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48|||L||Standard Error|Mean
168698|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48||Month 48|||L||Standard Error|Mean
168699|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42|||L||Standard Error|Mean
168700|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42||Month 42|||L||Standard Error|Mean
168701|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36|||L||Standard Error|Mean
168702|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36||Month 36|||L||Standard Error|Mean
168703|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30|||L||Standard Error|Mean
168704|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30||Month 30|||L||Standard Error|Mean
168705|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24|||L||Standard Error|Mean
168706|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24||Month 24|||L||Standard Error|Mean
168707|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18|||L||Standard Error|Mean
168708|NCT00144339|Secondary|Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18||Month 18|||L||Standard Error|Mean
168709|NCT00144339|Secondary|Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12||Month 12|||L||Standard Error|Mean
168733|NCT00144339|Secondary|Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)|From Day 1 to 4 years|||days/patient year||Standard Error|Mean
168734|NCT00144339|Secondary|Number of Exacerbation Leading to Hospitalization|Estimated number of exacerbations leading to hospitalizations per patient year|From Day 1 to 4 years|||Number per patient year|||Number
168735|NCT00144339|Secondary|Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization||From Day 1 to 4 years|||Participants|||Number
168736|NCT00144339|Secondary|Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)||Day 1 to 4 years|||months||95% Confidence Interval|Median
168737|NCT00144339|Secondary|Number of Exacerbation Days Per Patient Year|Number of exacerbation days normalized by treatment exposure|Day 1 to 4 years|||days/patient year||Standard Error|Mean
168738|NCT00144339|Secondary|Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation||Day 1 to 4 years|||Participants|||Number
168739|NCT00144339|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year||Day 1 to 4 years|||number per patient year||Standard Error|Mean
168740|NCT00144339|Secondary|Time to First Exacerbation|Chronic obstructive pulmonary disease (COPD) exacerbation|From Day 1 to 4 years|||months||95% Confidence Interval|Median
168741|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
168742|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
168743|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
168744|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.|||ml/year||Standard Error|Median
168745|NCT00144339|Secondary|Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).|From month 6 to 4 years|||Score on scale per year||Standard Error|Mean
168746|NCT00144339|Secondary|Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
168747|NCT00144339|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
168748|NCT00144339|Secondary|Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
168749|NCT00144339|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC|From day 30 to 4 years|||ml/year||Standard Error|Mean
168750|NCT00144339|Secondary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days|||ml/year||Standard Error|Median
168751|NCT00144339|Secondary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1|Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.|||ml/year||Standard Error|Median
168752|NCT00144339|Primary|Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years|||ml/year||Standard Error|Mean
168753|NCT00144339|Primary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years|Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.|From day 30 to 4 years|||ml/year||Standard Error|Mean
168754|NCT00144300|Secondary|Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs|Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.|Screen (Baseline) and final visit (24 months)|TSlab - treated set with non-missing laboratory evaluations||participants|||Number
168755|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 2 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168756|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|2 years|TS - treated set||Score on a scale||Standard Deviation|Mean
168757|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline, 1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168758|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168759|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline|This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).|Baseline|TS - treated set||Score on a scale||Standard Deviation|Mean
168760|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 2 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168761|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|2 years|TS - treated set||Score on a scale||Standard Deviation|Mean
168762|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline, 1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168763|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168764|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline|Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.|Baseline|TS - treated set||Score on a scale||Standard Deviation|Mean
168765|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 2 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168766|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|2 years|TS - treated set||Score on a scale||Standard Deviation|Mean
168767|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline, 1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168768|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|1 year|TS - treated set||Score on a scale||Standard Deviation|Mean
168769|NCT00144300|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline|Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.|Baseline|TS - treated set||Score on a scale||Standard Deviation|Mean
168770|NCT00144300|Secondary|Hoehn and Yahr Scale at 2 Years|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 2 years|TS - treated set||Participants|||Number
168771|NCT00144300|Secondary|Hoehn and Yahr Scale at 1 Year|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Up to 1 year|TS - treated set||Participants|||Number
168772|NCT00144300|Secondary|Hoehn and Yahr Scale at Baseline|This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)|Baseline|TS - treated set||Participants|||Number
168773|NCT00144300|Secondary|Expert Panel Overall Assessment Following 1 Year on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 1 years|FAS LOCF - full analysis set with last observation carry forward||Participants|||Number
168774|NCT00144300|Primary|Expert Panel Overall Assessment Following 2 Years on Drug|Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments|up to 2 years|FAS LOCF - full analysis set with last observation carry forward||Participants|||Number
168775|NCT00144170|Secondary|Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.|"Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.~The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time."|up to 75 weeks of treatment|Safety Set (SAF), included all patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
168776|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 96)||Baseline to Week 96|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168777|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 88)||Baseline to Week 88|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168778|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 80)||Baseline to Week 80|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168779|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 72)||Baseline to Week 72|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168780|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 64)||Baseline to Week 64|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168781|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 56)||Baseline to Week 56|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168782|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 48)||Baseline to Week 48|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168783|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 40)||Baseline to Week 40|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168784|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 32)||Baseline to Week 32|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168785|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 24)||Baseline to Week 24|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168786|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 16)||Baseline to Week 16|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168787|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 8)||Baseline to Week 8|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168788|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 4)||Baseline to Week 4|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168789|NCT00144170|Secondary|Mean Change From Baseline in CD4+ Cell Count (Week 2)||Baseline to Week 2|Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count||Cells/mm3||Standard Deviation|Mean
168790|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<50 copies/mL|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168791|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<50 copies/mL|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168792|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<50 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168793|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<50 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168794|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<50 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168795|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<50 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168796|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<50 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168797|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<50 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168798|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<50 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
171390|NCT00115063|Primary|Percent Change From Baseline Weight||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||Percent change||Standard Error|Mean
168802|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<50 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168803|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<50 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168804|NCT00144170|Secondary|Virologic Response|Virologic response defined as Viral Load<50 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168805|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response defined as Viral Load<400 copies/mL|week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168806|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response defined as Viral Load<400 copies/mL|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168807|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response defined as Viral Load<400 copies/mL|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168808|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response defined as Viral Load<400 copies/mL|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168809|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response defined as Viral Load<400 copies/mL|Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168810|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response defined as Viral Load<400 copies/mL|Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168811|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response defined as Viral Load<400 copies/mL|Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168812|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response defined as Viral Load<400 copies/mL|Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168813|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response defined as Viral Load<400 copies/mL|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168814|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response defined as Viral Load<400 copies/mL|Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168815|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response defined as Viral Load<400 copies/mL|Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168816|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response defined as Viral Load<400 copies/mL|Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168817|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response defined as Viral Load<400 copies/mL|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168818|NCT00144170|Secondary|Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks|Virologic response defined as Viral Load<400 copies/mL|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168819|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response defined as Viral Load<400 copies/mL|Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168820|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 96)||Baseline to Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168821|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 88)||Baseline to Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168822|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 80)||Baseline to Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168823|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 72)||Baseline to Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168824|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 64)||Baseline to Week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168825|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 56)||Baseline to Week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168826|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 48)||Baseline to Week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168827|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 40)||Baseline to Week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168828|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 32)||Baseline to Week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168829|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 24)||Baseline to Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168830|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 16)||Baseline to Week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168831|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 8)||Baseline to Week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168832|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 4)||Baseline to Week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168833|NCT00144170|Secondary|Median Change From Baseline in Viral Load (Week 2)||Baseline to Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
168834|NCT00144170|Secondary|Virologic Response at Week 96|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 96|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168835|NCT00144170|Secondary|Virologic Response at Week 88|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168836|NCT00144170|Secondary|Virologic Response at Week 80|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168837|NCT00144170|Secondary|Virologic Response at Week 72|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168838|NCT00144170|Secondary|Virologic Response at Week 64|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168839|NCT00144170|Secondary|Virologic Response at Week 56|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168840|NCT00144170|Secondary|Virologic Response at Week 48|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 48|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168841|NCT00144170|Secondary|Virologic Response at Week 40|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168842|NCT00144170|Secondary|Virologic Response at Week 32|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168843|NCT00144170|Secondary|Virologic Response at Week 24|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168844|NCT00144170|Secondary|Virologic Response at Week 16|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168845|NCT00144170|Secondary|Virologic Response at Week 8|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168846|NCT00144170|Secondary|Virologic Response at Week 4|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168847|NCT00144170|Secondary|Virologic Response at Week 2|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168848|NCT00144170|Secondary|Virologic Response|Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1|Week 2 through Week 96 (at any point during trial)|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168849|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
168850|NCT00144170|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
168938|NCT00142597|Primary|Change in Mu-opioid Receptor Occupancy|Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.|measured from baseline to week 5|||Unitless: binding potential is Bmax/Kd||Standard Deviation|Mean
168851|NCT00144170|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
168852|NCT00144170|Secondary|Treatment Response at Week 96|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 96 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168853|NCT00144170|Secondary|Treatment Response at Week 88|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 88|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168854|NCT00144170|Secondary|Treatment Response at Week 80|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 80|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168855|NCT00144170|Secondary|Treatment Response at Week 72|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 72|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168856|NCT00144170|Secondary|Treatment Response at Week 64|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168857|NCT00144170|Secondary|Treatment Response at Week 56|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168858|NCT00144170|Secondary|Treatment Response at Week 40|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 40|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168859|NCT00144170|Secondary|Treatment Response at Week 32|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 32|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168860|NCT00144170|Secondary|Treatment Response at Week 24|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168861|NCT00144170|Secondary|Treatment Response at Week 16|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168862|NCT00144170|Secondary|Treatment Response at Week 8|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
168863|NCT00144170|Secondary|Treatment Response at Week 4|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168864|NCT00144170|Secondary|Treatment Response at Week 2|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168865|NCT00144170|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
168866|NCT00144170|Primary|Treatment Response at Week 48|Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|after 48 weeks of treatment|Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
168948|NCT00142298|Secondary|To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
168867|NCT00144027|Primary|Antipsychotic Medication Adherence|The self-report adherence measure asked patients to think about the past four weeks and report to what extent they took their medication for mental, emotional, or nervous problems and report the result on a 5-point Likert scale ranging from ‘I never missed taking my medicine’ to ‘I stopped taking the medicine altogether’. Patients who received depot injections were asked to think about the past six months. Self-report adherence was defined as 1=I never missed taking my medicine’ and 0=any other response to the medication adherence question.|6-months|"Percent of participants who reported never missed taking my medication at 6-months"||percentage of participants|||Number
168868|NCT00143845|Secondary|To Evaluate Surrogate Markers of GVHD and Correlate These With Clinical Outcomes During the Above Trial||one year||||||
168869|NCT00143845|Primary|Percentage of Participants With Progression Free Survival|"The second primary objective was to determine the percentage of participants with progression free survival following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.~We define disease progression as disease recurrence within 180 days of transplant."|two years|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.||percentage of participants|||Number
168870|NCT00143845|Primary|Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grades 2-4|"The primary objective of this study was to establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies. Glucksberg staging was used for organ grading of GVHD. Clinical GVHD was assessed as follows:~Grade 0: No stage 1-4 of any organ Grade 1: Stage 1-2 rash and no liver or gut involvement Grade 2: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 GI Grade 3: Stage 0-3 skin with Stage 2-3 liver, or Stage 2-4 GI Grade 4: Stage 4 skin rash, or Stage 4 liver involvement"|100 days|54 patients were enrolled however 9 patients did not receive planned donor lymphocyte infusion. 45 patients were analyzed.||percentage of participants|||Number
168871|NCT00142935|Secondary|Non-fatal Overdose|Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews|||participants|||Number
168872|NCT00142935|Secondary|Fatal Overdose|Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records.|Within six months from release of incarceration|||participants|||Number
168873|NCT00142935|Secondary|Drug Use|Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews|||participants|||Number
168874|NCT00142935|Primary|HIV Risk Behaviors - Self Report|Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview.|6 month follow-up interviews|||participants|||Number
168875|NCT00142935|Primary|Time to MMT Initiation Post Release Based on Clinic Chart Review|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review.|within 30 days post release from incarceration|Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis.||days||Standard Deviation|Mean
168876|NCT00142935|Primary|Treatment Engagement|Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review.|within 30 days post release of incarceration|We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review.||participants|||Number
168877|NCT00142909|Secondary|Diastolic Blood Pressure||12 weeks|||mm Hg||Standard Deviation|Mean
168878|NCT00142909|Secondary|Diastolic Blood Pressure||1 Week|||mm Hg||Standard Deviation|Mean
168879|NCT00142909|Secondary|Systolic Blood Pressure||12 weeks|||mm Hg||Standard Deviation|Mean
168880|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|12 weeks|||units on a scale||Standard Deviation|Mean
168881|NCT00142909|Secondary|Systolic Blood Pressure||1 Week|||mm Hg||Standard Deviation|Mean
168882|NCT00142909|Primary|SOWS: the Subjective Opiate Withdrawal Scale|The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5‐point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: http://www.ncbi.nlm.nih.gov/books/NBK64244/|1 Week|||units on a scale||Standard Deviation|Mean
168920|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up|6 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).||participants|||Number
168883|NCT00143598|Secondary|Quality of Life|"The SF-36 is a well-validated generic quality-of-life (QOL) instrument. It includes questions on both physical and mental health. Higher scores indicate a better QOL. The VEINES-QOL is a venous-disease specific QOL measure that consists of 25 items that quantify venous disease effect on QOL, and an embedded symptom sub-questionnaire (VEINES-Sym) with 10 items that measures venous symptoms. Higher scores are associated with better QOL.~The VEINES-QOL/Sym and SF-36 use the standard method for scoring questionnaires with items with different response scales that is now routinely used. Raw scores are first transformed to z score equivalents (mean, 0; standard deviation, 1), which then are transformed to T scores (mean, 50; standard deviation, 10) to give an easily understood range of scores. A person-specific estimate is imputed for any missing item in cases where the patient answered at least 50% of the items in the scale."|24 months|Patients who completed the SF-36 and VEINES-QOL at 24 months follow-up.||Scores on a scale||Standard Deviation|Mean
168884|NCT00143598|Secondary|Incidence of Objectively Confirmed Recurrent Venous Thromboembolism (VTE), Death From VTE and Major Bleeding||During 2-year follow up|||participants|||Number
168885|NCT00143598|Secondary|Severity of PTS, Including Incidence of Venous Ulcer|"Highest Villalta at or after 6 month visit~The Villalta Scale for assessment of the post-thrombotic syndrome The Villalta scale has a range of 0-33. A Villalta scale score >4 indicates post-thrombotic syndrome (severity of post-thrombotic syndrome is categorized as 5-9 points, mild; 10-14 points, moderate; >14 points or presence of an ulcer, severe).~Higher values signify worse outcome. Points on each item in the scale are simply summed to a total score."|6-24 months.|Highest Villalta score at or after 6 month visit (missing for 48 patients in each group).||participants|||Number
168886|NCT00143598|Primary|Incidence of Post-thrombotic Syndrome (PTS)||During 2-year follow up|Intention to treat.||participants|||Number
168887|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.|||participants|||Number
168888|NCT00143507|Secondary|Cardiovascular Death, or Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
168889|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, New Onset or Worsening Heart Failure or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
168890|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome, or Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
168891|NCT00143507|Secondary|Hospitalisation for Acute Coronary Syndrome (Unstable Angina or Acute Myocardial Infarction)||From the date of randomisation to the date of first occurrence of the first event, up to 3 years.|||participants|||Number
168892|NCT00143507|Secondary|Hospitalisation for Unstable Angina||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||participants|||Number
168893|NCT00143507|Secondary|Hospitalisation for Coronary Revascularisation||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||participants|||Number
168894|NCT00143507|Secondary|Coronary Artery Disease Death|Death due to heart failure, acute myocardial infarction or cardiac procedure|From the date of randomisation to death, up to 3 years.|||participants|||Number
168895|NCT00143507|Secondary|All-cause of Mortality||From the date of randomisation to death, up to 3 years.|||participants|||Number
168896|NCT00143507|Secondary|Hospitalisation for New Onset or Worsening Heart Failure||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||participants|||Number
168897|NCT00143507|Secondary|Hospitalisation for Acute Myocardial Infarction||From the date of randomisation to the date of first occurrence of the event, up to 3 years.|||Participants|||Number
168898|NCT00143507|Secondary|Cardiovascular Death|Cardiovascular death including sudden death of unknown cause|From the date of randomisation to death, up to 3 years.|||participants|||Number
168899|NCT00143507|Primary|Primary Composite Endpoint|First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).|From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.|||participants|||Number
168900|NCT00143455|Secondary|Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)|Improvement of ≥ 1 tumor related symptom = clinical benefit responder. Pain improvement = decrease of ≥ 1 National Cancer Institute (NCI) grade from baseline of ≥ 1 symptom of NCI pain category, without pain symptom worsening. Cough, dyspnea and hemoptysis improvement = decrease of ≥ 1 NCI grade from baseline. Positive weight change ≥ 5 percent gain from baseline. Positive analgesic consumption = change from baseline from opioid to non-opioid category.|Every 3 weeks for up to 6 months on study treatment|Data were not analyzed.||participants|||Number
168901|NCT00143455|Secondary|European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)|The EORTC QLQ-C30 scales include 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/QL scale and 9 symptom scales: nausea and vomiting, pain, fatigue, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QL represents a high QL (better patient state), and for a symptom scale/item represents a high level of symptomatology/problems (worse patient state).|Baseline, at every cycle (Day -1, Day 1 of cycle before treatment), at the end of the treatment, and every 2 months during follow-up|Data were not analyzed.||scores on a scale||Standard Deviation|Mean
168921|NCT00143312|Primary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up|12 months|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).||participants|||Number
168949|NCT00142298|Secondary|To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
168902|NCT00143455|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from date of randomization to the date of the first documentation of tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.||months||95% Confidence Interval|Median
168903|NCT00143455|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients) of Cohort 2 (after the 29 September 2003 protocol amendment), analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer.||months||95% Confidence Interval|Median
168904|NCT00143455|Primary|Overall Survival for the Per Protocol (PP) Population|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|PP population = a subset of the Cohort 2 FAP. The subjects had to be eligible (subject had no major protocol deviations from inclusion and noninclusion criteria), evaluable for response, without any major protocol deviations during the study.||months||95% Confidence Interval|Median
168905|NCT00143455|Secondary|Number of Subjects With Overall Confirmed Response|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.||participants|||Number
168906|NCT00143455|Primary|Overall Survival (OS) for the Full Analysis Population (FAP)|OS was defined as the time from date of randomization to date of death due to any cause. For a subject not expiring, the OS time was censored on the last date of contact that they were known to be alive. The Kaplan-Meier method was used to analyze variables of duration and event associated with possible censoring and estimate the medians survival by treatment groups. The confidence intervals for the medians were calculated using the Brookmeyer and Crowley’s method.|Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment)|FAP = Full analysis population (all treated patients)analyzed in the arm they were assigned by randomization, assuming they had a confirmed small cell lung cancer. The enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory.||months||95% Confidence Interval|Median
168907|NCT00143403|Secondary|Overall Survival Rates|Probability of being alive was calculated in a yearly increment.|Median follow-up time (42 months)|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).||survival rate|||Number
168908|NCT00143403|Primary|Disease Free Survival (DFS)|time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.|last tumor assessment date or cut-off date, whichever is earlier.|Full analysis set = all treated subjects according to randomization: n=153, 153 for 5-FU/FA & Irinotecan + 5-FU/FA, respectively. Safety analysis set (for Adverse Events) = all treated subjects according to treatment actually received (1 subject randomized to 5-FU/FA actually received treatment from Irinotecan + 5-FU/FA). n=152, 154 as above).||months||95% Confidence Interval|Median
168909|NCT00143390|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||95% Confidence Interval|Median
168910|NCT00143390|Secondary|Overall Survival (OS)|OS is defined as time from the date of randomization to the date of death.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as subjects who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||95% Confidence Interval|Median
168933|NCT00142818|Secondary|Naltrexone/Modafinil-treated Subjects Will Have Fewer Days of Cocaine Use, More Abstinent Days From Alcohol, and Fewer Heavy Drinking Days During the Follow up Period Compared to Placebo-treated Subjects.||4+13 weeks||||||
168934|NCT00142818|Secondary|Modafinil-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks||||||
168911|NCT00143390|Secondary|Number of Participants With Clinical Benefit - Investigator Assessment|Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.||participants|||Number
168912|NCT00143390|Secondary|Number of Participants With Objective Response - Investigators Assessment|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol. Further more, participants with bone metastasis alone or not evaluable based on RECIST were excluded from this analysis.||participants|||Number
168913|NCT00143390|Secondary|Time to Progression (TTP) - Investigators Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||90% Confidence Interval|Median
168914|NCT00143390|Primary|Time to Progression (TTP) - Expert Evaluation Committee Assessment|Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).|Up to 2008 days of the treatment|Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.||months||95% Confidence Interval|Median
168915|NCT00143312|Secondary|Survival Without Proven or Probable Invasive Fungal Infection (IFI)|Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits|6 months, 12 months|Complete case analysis using MITT population (ie, all subjects who had at least 1 dose of study medication & at least 1 post-enrollment efficacy assessment & a previous diagnosis of proven or probable IFI, confirmed by Data Review Committee) & either provided an IFI assessment at follow-up visit, died or experienced an IFI before that visit.||participants|||Number
168916|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)|Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Two subjects experienced a recurrent proven or probable IFI.||days|||Number
168917|NCT00143312|Secondary|Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. One subject in the MITT population experienced a new IFI.||days|||Number
168918|NCT00143312|Secondary|Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)|Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.|12 months|Modified intent-to-treat (MITT) population (considered evaluable for efficacy) consisted of all subjects who had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & had a previous diagnosis of proven or probable IFI, confirmed by the Data Review Committee. Three subjects in the MITT population experienced an IFI.||days|||Number
168919|NCT00143312|Secondary|Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit|Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit|150 days|Complete case analysis (ie, outcome must be observed and/or subject must be evaluable for entire period of interest) using modified intent-to-treat (MITT) population (ie, subjects had at least 1 dose of voriconazole & at least 1 post-enrollment efficacy assessment & previous diagnosis of proven or probable IFI, confirmed by Data Review Committee).||participants|||Number
168935|NCT00142818|Secondary|Naltrexone-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.||4+13 weeks||||||
168922|NCT00143247|Primary|Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||mL/min/mm Hg||Standard Deviation|Mean
168923|NCT00143247|Secondary|Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.|6 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||participants|||Number
168924|NCT00143247|Secondary|Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment|Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||participants|||Number
168925|NCT00143247|Secondary|Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment|Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.|3 to >=108 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||participants|||Number
168926|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)|Observed values by duration of treatment.|6 to 120 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent binding||Full Range|Median
168927|NCT00143247|Primary|Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment|Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||liters||Standard Deviation|Mean
168928|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment – Subjects With Type 2 Diabetes (Using Insulin at Study Entry)|observed values by duration of treatment.|36 to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent binding||Full Range|Median
168929|NCT00143247|Secondary|Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes|Observed values by duration of treatment.|36 months to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent binding||Full Range|Median
168930|NCT00143247|Secondary|Severe Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.|0-132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||severe events / 100 subject-months|||Number
168931|NCT00143247|Secondary|Hypoglycemic Event Rates by Interval of Exubera Treatment|Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.|0 to 132 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||events / subject-month|||Number
168932|NCT00143247|Secondary|Change in Glycosylated Hemoglobin by Duration of Exubera Treatment|Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.|Baseline to 126 months|173 subjects received at least one treatment. The safety analysis set (subjects who received at least one dose of EXU treatment) were included in analysis. n = subjects who had outcome measure data available at particular time points. There was no imputation for missing data.||percent HbA1C||Standard Deviation|Mean
168939|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]|"The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up.~Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated."|52 weeks,104 weeks|"In Group C: other feeder study reporting group, there were only 13 patients; hence, no summary statistics were performed. Only listings were generated."|||||
168940|NCT00142298|Primary|Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]|The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA < 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks,104 weeks|The per protocol population. n= is the number of HBeAg-positive/HBeAg-negative patients from per protocol population who achieved maintained response at the end of treatment and had off-treatment assessment to determine the sustained response at that time point or lost sustained response before the off-treatment timepoint.||Percentage of Participants||95% Confidence Interval|Number
168941|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient’s baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|52 weeks,104 weeks|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.||Percentage of Participants||95% Confidence Interval|Number
168942|NCT00142298|Primary|Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]|Maintained clinical response is defined as achievement of serum HBV DNA < 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient’s baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.||Percentage of Participants||95% Confidence Interval|Number
168943|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done on the PP population, separately for the HBeAg-positive and HBeAg-negative subpopulation (status as feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.||Percentage of Participants||95% Confidence Interval|Number
168944|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|52 weeks, 104 weeks|Per protocol (PP) population. The PP analysis was done separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.||Percentage of Participants||95% Confidence Interval|Number
168945|NCT00142298|Primary|Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]|The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA < 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.|156 weeks, 208 weeks (from feeder study baseline)|Per protocol (PP) population. The PP analysis was done on separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.||Percentage of participants||95% Confidence Interval|Number
168946|NCT00142298|Secondary|To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
168947|NCT00142298|Secondary|To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients||52 weeks, 104 weeks, 156 weeks, 208 weeks||||||
168950|NCT00142168|Secondary|Minor Response Rate|A minor response is defined as having achieved >25% but less than 50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.||participants|||Number
168951|NCT00142168|Secondary|Major Response Rate|Major response rate is the number of participants who achieve at a PR or better. A PR or better will be defined as achieving a >50% reduction in serum IgM levels.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.||participants|||Number
168952|NCT00142168|Primary|Overall Response|Overall response is the total number of participants who respond to therapy. Patients achieving a complete response (CR) will be defined as having achieved resolution of all symptoms, normalization of their serum IgM levels with complete disappearance of their IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly during any point while in this study and normal bone marrow biopsy. Patients achieving a partial response (PR) and a minor response (MR) will be defined as achieving a > 50% and > 25% reduction in serum IgM levels, respectively, during any point while in this study. Patients with stable disease (SD) will be defined as having < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WMduring any point while in this study.|34.3 months|Evaluable patients. 4 participants were withdrawn for adverse events and were unevaluable.||participants|||Number
168953|NCT00142168|Primary|Time to Progression|Time to progression is measured as the length in time in months from starting therapy until progression, defined as 25% increase in serum IgM from nadir.|34.3 months|All enrolled patients||months||Full Range|Median
168954|NCT00142116|Primary|Time to Progression|Time to disease progression (TTP) was calculated from the start of therapy using the Kaplan-Meier method.|49.1 months|||months||Full Range|Median
168955|NCT00142116|Secondary|To Identify the Mechanism(s) of Action for Combined Thalidomide and Rituximab Activity.||3 years||||||
168956|NCT00142116|Primary|Objective Response Rate|Response determinations were made using modified consensus panel criteria from the Third International Workshop on WM, and response rates were determined on an evaluable basis. A complete response was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. Patients achieving a partial response and a minor response were defined as achieving a more than or equal to 50% and more than or equal to 25% reduction in serum IgM levels, respectively. Patients with stable disease were defined as having less than 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM. Progressive disease was defined as a greater than 25% increase in serum IgM level occurred from the lowest attained response value or progression of clinically significant disease-related symptom(s).|3 years|Intent-to-treat basis||participants|||Number
168957|NCT00141921|Secondary|Improvement From Study 20030211 Baseline in Joint Pain|"Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10).~Improvement from baseline = (Baseline Value – Post-baseline Value)."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264|Participants who received at least one dose of investigational product and who completed the joint pain assessment at Study 20030211 baseline, and with available data at each time point.||units on a scale||Standard Deviation|Mean
168958|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
168959|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
168960|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
168983|NCT00141817|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population: Randomized participants who took 1 dose of pantoprazole and had at least 4 single-dose blood samples for pharmacokinetic (PK) analyses.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
170897|NCT00120042|Primary|Placental Retention Rate|If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.|3 years|||participants|||Number
168961|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
168962|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
168963|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (not at all) to 3 (Very much). The CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data and with available data at each time point.||percent improvement||Standard Deviation|Mean
168964|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in Children’s Dermatology Life Quality Index (CDLQI) Total Score|"The Children’s Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were ≥ 13 years old, the text instrument was completed by the participants themselves. Participants ≥ 8 but < 13 years old used the cartoon version of the instrument and participants ≤ 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264|Participants who received at least one dose of investigational product with baseline data, and with available data at each time point.||percent improvement||Standard Deviation|Mean
168965|NCT00141921|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Clear (0) or Almost Clear (1)|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percentage of participants|||Number
168966|NCT00141921|Secondary|Percent Improvement From Study 20030211 Baseline in PASI Score|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100."|Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percent improvement||Standard Deviation|Mean
168967|NCT00141921|Secondary|Percentage of Participants With a PASI 90 Response|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percentage of participants|||Number
168968|NCT00141921|Secondary|Percentage of Participants With a PASI 75 Response|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product with available data at each time point.||percentage of participants|||Number
168984|NCT00141778|Secondary|Perioperative C-reactive Protein (CRP) Concentrations|C-reactive protein was measured at several time points (see table) over the course of the study.|Perioperative period|CRP was measured in all subjects from the intention-to-treat analysis for which plasma was available at those time points.||ug/mL||Standard Deviation|Mean
169527|NCT00135330|Secondary|Change in Waist-to-hip Ratio|Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set||ratio (cm/cm)||Standard Error|Least Squares Mean
168969|NCT00141921|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)|"A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and weeks 12, 48, 96, 144, 192, 240 and 264|Participants who received at least one dose of investigational product and with available data at each time point.||percentage of participants|||Number
168970|NCT00141921|Secondary|Number of Participants Who Developed Anti-etanercept Antibodies|"Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay.~Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline."|264 weeks|Participants who received at least one dose of investigational product and had a post-baseline antibody result.||participants|||Number
168971|NCT00141921|Secondary|Number of Participants With Grade 3 and 4 Laboratory Toxicities|The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.|264 weeks|Participants who received at least one dose of investigational product.||participants|||Number
168972|NCT00141921|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs||264 weeks|Participants who received at least one dose of investigational product.||participants|||Number
168973|NCT00141921|Secondary|Exposure-adjusted Adverse Event Rates|"The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period.~Exposure-adjusted event rate per 100 patient years = total number of events / patient years * 100.~Multiple occurrences of the same event for a participant were counted as multiple events."|264 weeks|Participants who received at least one dose of investigational product.||events per 100 patient years|||Number
168974|NCT00141921|Secondary|Number of Participants With Injection Site Reactions|An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.|264 weeks|Participants who received at least one dose of investigational product.||participants|||Number
168975|NCT00141921|Primary|Number of Participants With Adverse Events|"A serious adverse events is any AE that~is fatal~is life threatening~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity).~An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer."|264 Weeks|Participants who received at least one dose of investigational product.||participants|||Number
168976|NCT00141817|Primary|Plasma Concentrations After Multiple Doses||Hours 2 and 4 on Day 7|Multiple-Dose Valid-for-Evaluation Population: Randomized participants who had concentration evaluations of pantoprazole either at 2 hours or at 4 hours after single dose and after at least 5 consecutive doses. n=participants who had data available at that specific time point.||ng/mL||Standard Deviation|Mean
168977|NCT00141817|Primary|Terminal-Phase Volume of Distribution (Vz/F)|Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||liter per kilogram (L/kg)||Standard Deviation|Mean
168978|NCT00141817|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||liter per hour per kilogram (L/h/kg)||Standard Deviation|Mean
168979|NCT00141817|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||hours||Standard Deviation|Mean
168980|NCT00141817|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||ng*h/mL||Standard Deviation|Mean
168981|NCT00141817|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).|Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population.||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
168982|NCT00141817|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose|Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.||hours||Standard Deviation|Mean
168985|NCT00141778|Secondary|Perioperative Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations|Plasminogen activator inhibitor-1 (PAI-1) was measured at several time points (see table) over the course of the study.|Perioperative period|PAI-1 was measured in all subjects in the intention-to-treat analysis for which plasma was available.||ng/mL||Standard Deviation|Mean
168986|NCT00141778|Secondary|Perioperative Interleukin(IL)-6 Concentrations|Interleukin-6 was measured at several time points (see time points in table) over the course of the study|Perioperative period|All participants included in the intention-to-treat analysis who had available plasma samples.||pg/ml||Standard Deviation|Mean
168987|NCT00141778|Secondary|Stroke|Percentage of patients in each study group who experience a cerebrovascular event, confirmed by CT.|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average depending on the study arm.|The intention-to-treat analysis included all those who received any study drug.||percentage of patients|||Number
168988|NCT00141778|Secondary|Death|The percentage of patients in each study arm who died.|Measured until the time of hospital discharge|The intention-to-treat analysis included all patients who received any study medication.||percentage of patients|||Number
168989|NCT00141778|Secondary|Length of Hospital Stay (Days)||Measured from the day of surgery until the time of hospital discharge|The intention-to-treat analysis included anyone who had received any study medication.||days||Standard Deviation|Mean
168990|NCT00141778|Secondary|Time to Tracheal Extubation|It is the time in minutes that it took to extubate the patient after surgery.|It is the time (in minutes) from admission to the ICU until tracheal extubation|The intention-to-treat analysis included all patients who received any study medication.||minutes||Standard Deviation|Mean
168991|NCT00141778|Secondary|Hypokalemia|Percentage of patients who had a serum potassium concentrations <3.5 milliequivalents (mEq)/L|Measured until the time of hospital discharge, which was an average of 5.7 to 6.8 days depending on the treatment arm.|||percentage of patients|||Number
168992|NCT00141778|Secondary|Hypotension|Percentage of patients with hypotension defined as a systolic blood pressure <90 mmHg and/or prolonged requirement for vasopressor use.|Measured during and after surgery, until discharge, from 5.7 to 6.8 days on average.|The intention-to-treat analysis included anyone who had received any medication.||percentage of patients|||Number
168993|NCT00141778|Secondary|Acute Renal Failure|Percentage of patients with a creatinine concentrations >2.5mg/dl|Measured until the time of hospital discharge, from 5.7 to 6.8 days on average, depending on the study group.|The intention-to-treat analysis included anyone who had received any study medication.||percentage of patients|||Number
168994|NCT00141778|Primary|Postoperative Atrial Fibrillation|The primary endpoint of the study was the percentage of patients with electrocardiographically confirmed AF of at least 10 secs duration at any time following the end of surgery until hospital discharge, an average from 5.7 days in the ramipril group to 6.8 days in the placebo group. Patients were monitored continuously on telemetry throughout the postoperative period until discharge. Electrocardiograms were obtained for any rhythm changes detected on telemetry monitoring, and in addition, electrocardiograms were performed preoperatively, at admission to the intensive care unit, and daily starting on postoperative day 1. All electrocardiograms and rhythm strips were reviewed in a blinded fashion by a single cardiac electrophysiologist.|Measured from admission to the ICU until discharge from hospital|Four hundred fifty-eight patients were randomized. Of these 445 took study medication and were included in the intention-to-treat analysis.||percentage of patients|||Number
168995|NCT00141765|Primary|Percent of Participants With Progression Free Survival at 1 Year|The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.|1 year post transplant|||percentage of participants|||Number
168996|NCT00141739|Secondary|The Impact of Tumor Necrosis Factor (TNF) Polymorphisms on Response to Therapy.||100 days|This was not analyzed in the population and there are no plans to analyze this in the future. The study is complete and the principal investigator has left the institution.|||||
168997|NCT00141739|Secondary|Day +7 TNFR1 Ratio in TBI-Treated Patients vs. Non-TBI-Treated Patients|The effect of etanercept on plasma cytokine levels after Hematopoietic Stem Cell Transplantation (HSCT) was analyzed. Tumor Necrosis Factor Receptor 1 (TNFR1) ratios (TNFR1 posttransplantation day+7 / TNFR1pretransplantation baseline were calculated. Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|Day+7, post transplant|TBI versus non-TBI transplant conditioning||TNFR1 Ratio||Full Range|Mean
168998|NCT00141739|Secondary|The Number of Patients That Experience Idiopathic Pulmonary Syndrome (IPS)|The Effect of etanercept on the incidence of idiopathic pulmonary syndrome (IPS). Patients who received Total Body Irradiation (TBI) transplant conditioning were compared to those who received another form of transplant conditioning.|100 days|TBI versus Non-TBI transplant conditioning||Participants|||Count of Participants
168999|NCT00141739|Secondary|Number of Patients Experiencing Etanercept Toxicity|Toxicity of etanercept was evaluated by the following: the number of patients experiencing allergic reactions, the number of patients that discontinued etanercept early, the number of patients experiencing bacteremia, and the number of patients experiencing viral reactivations.|100 days|||participants|||Number
169000|NCT00141739|Primary|The Percentage of Participants Experiencing Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|"In order to determine whether etanercept, given prophylactically along with a standard Graft Versus Host Disease (GVHD) prevention regimen, will decrease the 100-day mortality and the rate of acute GVHD after allogeneic hematopoietic stem cell transplantation(HSCT), the incidence of grades 2-4 and grades 3-4 GVHD were calculated.~GVHD can be clinically graded as 0, I, II, III, or IV. Definition of grades are:~Grade 0 - No stage 1-4 of any organ Grade I - Stage 1-2 rash and no liver or gut involvement Grade II - Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gastrointestinal involvement Grade III - Stage 0-3 skin, with STage 2-3 liver, or Stage 2-3 gastrointestinal involvement Grade IV - Stage 4 skin, liver, or gastrointestinal involvement"|100 days|To provide Sufficient power||percentage of participants|||Number
169001|NCT00141726|Secondary|Percentage of Participants That Experience Grade 3 to 4 Adverse Events|To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.|continuously (and week 4, week 8 and week 12, week 20)|34 subjects were enrolled and evaluated for adverse events.||percentage of participants|||Number
169002|NCT00141726|Primary|Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO|Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .|week 12 post therapy|34 subjects were enrolled. Thirty-one of 34 subjects were evaluable for response, with three subjects completing <50% of scheduled dosing.||percent evaluable participants|||Number
169003|NCT00141518|Other Pre-specified|EQ-5D Visual Analog Scale (VAS) Score, up to Month 36|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169004|NCT00141518|Other Pre-specified|EQ-5D Descriptive Systems Summary Index Score, up to Month 36|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169005|NCT00141518|Other Pre-specified|UPDRS Part IV Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169006|NCT00141518|Other Pre-specified|UPDRS Part III Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169007|NCT00141518|Other Pre-specified|UPDRS Part II Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169008|NCT00141518|Other Pre-specified|UPDRS Part I Score, up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169009|NCT00141518|Other Pre-specified|UPDRS Total Score up to Month 36|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169010|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169011|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed’ is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. ‘Tapping random chase – accuracy’ is the percentage of accurate random chase taps.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of accurate taps||Standard Deviation|Mean
169012|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed’ is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||taps/20 seconds||Standard Deviation|Mean
169013|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Tapping at increased speed - accuracy’ is the percentage of accurate taps per all taps on computer-generated fields.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of accurate taps||Standard Deviation|Mean
169014|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Free tapping’ is defined as ____. ‘Free tapping accuracy’ is the percentage of accurate free taps per 20 seconds(?).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of tapping accuracy||Standard Deviation|Mean
169015|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed’ is a count of the number of taps per 20 seconds.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||taps/20 seconds||Standard Deviation|Mean
169123|NCT00141271|Secondary|Change in Verbal Fluency Controlled Word Association at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
169016|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Self-assessment’ scores were -3 (Off) to +3 (dyskinetic). ‘Off’ time is when PD symptoms are not adequately controlled by the drug. ‘Dyskinetic’ time is time with involuntary muscle movement. “0” is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to “0” means improvement, everything more away from “0” means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169017|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Satisfied with function’ scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169018|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Cramps’ scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169019|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Dyskinetic time’ is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169020|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Off time’ is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169021|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. ‘Dyskinetic time’ is time with involuntary muscle movement, and is represented as a percentage of total time of the last __ hours.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of 'dyskinetic' time||Standard Deviation|Mean
169124|NCT00141271|Secondary|Change in Verbal Fluency in Naming Categories at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
169022|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. On time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last __ hours."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of 'on' time||Standard Deviation|Mean
169023|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36|"The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Off time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage of 'off' time||Standard Deviation|Mean
169024|NCT00141518|Secondary|Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36|The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: ‘walking’, ‘satisfied’, ‘dyskinesia’, and ‘off’ and two objectively-measured: ‘tapping’ and ‘spiral’. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169025|NCT00141518|Secondary|PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169026|NCT00141518|Secondary|PDQ-39 Communication Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169027|NCT00141518|Secondary|PDQ-39 Cognition Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169528|NCT00135330|Secondary|Change in Hip Circumference|Change in hip circumference form baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set||cm||Standard Error|Least Squares Mean
169028|NCT00141518|Secondary|PDQ-39 Social Support Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169029|NCT00141518|Secondary|PDQ-39 Stigma Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169030|NCT00141518|Secondary|PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169031|NCT00141518|Secondary|PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169032|NCT00141518|Secondary|PDQ-39 Mobility Subscale Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169033|NCT00141518|Secondary|Parkinson’s Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169034|NCT00141518|Secondary|MADRS Suicidal Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169035|NCT00141518|Secondary|MADRS Pessimistic Thoughts Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169036|NCT00141518|Secondary|MADRS Inability to Feel Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169037|NCT00141518|Secondary|MADRS Lassitude Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169038|NCT00141518|Secondary|MADRS Concentration Difficulties Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169039|NCT00141518|Secondary|MADRS Reduced Appetite Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169040|NCT00141518|Secondary|MADRS Reduced Sleep Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169041|NCT00141518|Secondary|MADRS Inner Tension Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169218|NCT00140426|Secondary|Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. This was measured weekly from 0-18 weeks.|weekly|||weeks||Standard Error|Mean
169042|NCT00141518|Secondary|MADRS Apparent Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169043|NCT00141518|Secondary|MADRS Reported Sadness Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169044|NCT00141518|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36|MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169045|NCT00141518|Secondary|MMSE Language Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169046|NCT00141518|Secondary|MMSE Recall Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169047|NCT00141518|Secondary|MMSE Attention and Calculation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169048|NCT00141518|Secondary|MMSE Registration Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169049|NCT00141518|Secondary|MMSE Orientation Subscale Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169125|NCT00141271|Secondary|Change in Token Motor Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number of Tokens||Standard Error|Least Squares Mean
169050|NCT00141518|Secondary|Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36|The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.||units on a scale||Standard Deviation|Mean
169051|NCT00141518|Secondary|"Schwab and England Scale: Best On Period Stage From Baseline to Month 36"|"The Schwab and England scale was used to rate the subject’s best “on” period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). On time is when PD symptoms are well controlled by the drug."|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||percentage score on a scale||Standard Deviation|Mean
169052|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36|The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169053|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36|The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169054|NCT00141518|Secondary|Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36|The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.|Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169055|NCT00141518|Primary|Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010|Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability – is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36|All participants; n=fraction of number of participants younger than 65 years with indirect costs / number of participants assessed at given time point.||SEK 2010||Standard Deviation|Mean
169056|NCT00141518|Primary|Direct Monthly Non-medical Costs Per Participant, SEK 2010|Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
169057|NCT00141518|Primary|Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010|Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
169058|NCT00141518|Primary|Monthly Drug Costs Per Participant, SEK 2010|Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
169529|NCT00135330|Secondary|Change in Waist Circumference|Change in waist circumference from baseline to week 20|20 weeks|All Patients Who Have Both Baseline and At Least One Post Baseline Value in Full Analysis Set||cm||Standard Error|Least Squares Mean
169059|NCT00141518|Primary|Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010|"Total monthly costs include~Direct medical costs (inpatient care, outpatient care, and drug costs [including Duodopa cost and cost of concomitant anti-PD medication]).~Direct non-medical costs (nursing home, home help, personal assistance, informal care [from family member or friend] and transportation to inpatient, outpatient visits and nursing home).~Indirect costs (sick-leave and early retirement due to PD [applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden]).~The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK."|Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants|||SEK 2010|Participants|Standard Deviation|Mean
169060|NCT00141518|Primary|EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.||units on a scale||Standard Deviation|Mean
169061|NCT00141518|Primary|Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169062|NCT00141518|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.|Baseline (Month -3), Month 12|Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.||units on a scale||Standard Deviation|Mean
169063|NCT00141453|Secondary|Reciprocal (1/Serum Creatinine) of Serum Creatinine|The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.|Randomization to 5 years|Full analysis set=566||dL/mg/year||Inter-Quartile Range|Median
169064|NCT00141453|Secondary|The Change in Proteinuria|The median percentage change from baseline value in urinary protein:creatinine ratio|Randomization to 5 years|Full analysis set=566||Median percentage change in ratio|||Number
169065|NCT00141453|Secondary|Number of Participants Experiencing Cardiovascular Composite Outcomes|Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.|Within 5 years|Full analysis set=566||participants|||Number
169066|NCT00141453|Primary|Renal Composite Outcomes|first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease|Randomization to 5 years|Full analysis set=566||participants|||Number
169067|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Tumor Response|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with tumor response.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
169068|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With Exposure|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with PD 0322991 exposure.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
169189|NCT00141102|Secondary|Number of Subjects With Moderate to Severe Abdominal Symptoms|"Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to “Gastrointestinal Signs and Symptoms."|6 month treatment duration|ITT||participants|||Number
169069|NCT00141297|Primary|Correlation of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) With PD 0322991 Dose|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue, in correlation with respect to PD 0322991 dose.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
169070|NCT00141297|Primary|Inhibition of Cyclin-dependent Kinases 4 and 6 (Cdk4/6) Based on Phosphorylated Retinoblastoma (p-Rb) in Tumor Tissue|Phosphorylation of the retinoblastoma (Rb) protein by Cdk4/6 is typically required for human cancer cell proliferation. Tumor biopsies were to be performed, to demonstrate inhibition of Cdk4/6 based on reduction in phosphorylated Rb (p-Rb) in tumor tissue and p-Rb levels (fold decrease) were to be reported.|Baseline, C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Data was reported in individual participant listings and not summarized due to change in planned analysis, where baseline and post-baseline tumor biopsies for biomarkers were no longer required and were not obtained for all participants.|||||
169071|NCT00141297|Primary|Number of Participants With Best Response|Number of participants with best response. Complete response (CR): disappearance of all target and non-target lesions. Partial Response (PR): >=30% decrease in sum of longest diameter (LD) of lesions taking as reference baseline sum LD and no unequivocal progression in non-target lesions. Progressive disease (PD): >=20% increase in sum of LD of lesions taking as a reference smallest sum of the LD since treatment start, or the appearance of >=1 new lesion or unequivocal progression of existing non-target lesions. Stable disease (SD): neither shrinkage for PR nor increase for PD taking as reference smallest sum of LD since treatment start. SD was assessed following the first 2 cycles of treatment (>=2 cycles), 4 cycles of treatment (>=4 cycles), and 10 cycles of treatment (>=10 cycles). Participants may be reported in more than 1 category of SD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline up to end of treatment, assessed at C1D1, C1D8, C1D15, C1D22, thereafter Day 1, 8, 15, and 22 of every other cycle up to end of treatment (up to Cycle 93)|Modified Full Analysis Set included all enrolled participants who received at least 1 dose of study medication in Cycle 1 and completed a post-treatment response assessment.||participants|||Number
169072|NCT00141297|Primary|Percent Dose Recovered Unchanged (Percent Ae) in Urine: Food Effect|The percent Ae is defined in Outcome Measure 44. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.|||||
169073|NCT00141297|Primary|Percent Dose Recovered Unchanged in Urine (Percent Ae): Single Dose|Percent of dose recovered unchanged in urine over the 10 hour collection interval=100*(Ae divided by dose). Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||percentage of dose||Standard Deviation|Mean
169074|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Food Effect|The Ae is defined in Outcome Measure 42. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|Data was not collected because urine PK was not planned to be analyzed by food effect, as per protocol.|||||
169075|NCT00141297|Primary|Cumulative Amount of Drug Recovered Unchanged in the Urine (Ae): Single Dose|Ae is the cumulative amount of drug recovered unchanged in urine over the 10 hour collection interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Urine PK analysis was performed only in the MTD/RP2D groups (125 mg [21/28 Days] and 200 mg [14/21 Days]).|Hour 0 (pre-dose) to 10 hours post-dose on C1D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||microgram (mcg)||Standard Deviation|Mean
169084|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 8: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.|||||
169530|NCT00135330|Secondary|Change in Lean Body Mass During a Meal Challenge Test (MCT)|Change in lean body mass from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements||kg||Standard Error|Least Squares Mean
169076|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Food Effect|Terminal phase rate constant: absolute value of slope of a linear regression during terminal phase of natural-logarithm transformed concentration-time profile. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.|||||
169077|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile. The mean lambda (z) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||1/hour||Standard Deviation|Mean
169078|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 8: Multiple Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm transformed concentration-time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate the data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase.|||||
169079|NCT00141297|Primary|Terminal Phase Rate Constant [Lambda (z)] on Day 1: Single Dose|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural­-logarithm transformed concentration-­time profile.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase|||||
169080|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Rac at Day 14/21 = AUC (0-tau) at Day 14/21 divided by AUC (0-tau) at Day 1. The mean Rac for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ratio||Standard Deviation|Mean
169081|NCT00141297|Primary|Accumulation Ratio (Rac) on Day 8: Multiple Dose|Rac at Day 8 = AUC (0-tau) at Day 8 divided by AUC (0-tau) at Day 1.|Hour 0 (pre-dose), 1, 2, 4, 7, 10, and 24 hours post-dose on C1D1 and C1D8|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Rac.|||||
169082|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Food Effect|Volume of distribution: theoretical volume in which total amount of drug would need to be uniformly distributed to produce desired plasma concentration. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.|||||
169083|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. The mean Vz/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||liter||Standard Deviation|Mean
169531|NCT00135330|Secondary|Change in Body Fat Mass During a Meal Challenge Test (MCT)|Change in body fat mass form baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurements||kg||Standard Error|Least Squares Mean
169085|NCT00141297|Primary|Apparent Volume of Distribution (Vz/F) on Day 1: Single Dose|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the Vz/F.|||||
169086|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Food Effect|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.|||||
169087|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. The mean CL/F for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||liter/hour||Standard Deviation|Mean
169088|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 8: Multiple Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.|||||
169089|NCT00141297|Primary|Apparent Oral Clearance (CL/F) on Day 1: Single Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the CL/F.|||||
169090|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Food Effect|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).|||||
169091|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 8: Multiple Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).|||||
169101|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Single Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.|||||
169092|NCT00141297|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] on Day 1: Single Dose|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|It was not possible to calculate data for this outcome measure because calculation was dependent on the linear regression of data points collected during the terminal phase and the PK sampling was insufficient to characterize the terminal phase, which is needed for the calculation of the AUC (0 - ∞).|||||
169093|NCT00141297|Primary|Area Under the Curve From Time Zero to End of the Dosing Interval [AUC(0 to Tau)] on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the curve from time zero to end of the dosing interval (24 hours) [AUC (0-tau)]. The mean AUC (0-tau) for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
169094|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Food Effect|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
169095|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). The mean AUClast for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
169096|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 8: Multiple Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng*hour/mL||Standard Deviation|Mean
169097|NCT00141297|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) on Day 1: Single Dose|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.||nanogram*hour/milliliter (ng*hour/mL)||Standard Deviation|Mean
169098|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results were to be reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.|||||
169099|NCT00141297|Primary|Terminal Half-life (t½) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half. The mean t1/2 for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Standard Deviation|Mean
169100|NCT00141297|Primary|Terminal Half-life (t½ ) on Day 8: Multiple Dose|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|It was not possible to calculate data for t½ as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the t½.|||||
169102|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Food Effect|To determine impact of food (specifically high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. First 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. High-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Full Range|Median
169103|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The median Tmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Full Range|Median
169104|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||hours||Full Range|Median
169105|NCT00141297|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day.||hours||Full Range|Median
169106|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Food Effect|To determine the impact of food (specifically a high-fat meal) on PD 0332991 PK, participants were tested under fed and fasted conditions in crossover fashion. Each participant served as their own control. In this crossover fashion first dose was administered under either fed (high-fat meal) or fasted (10-hour fast) condition on Day 1 of Cycle 1 and 2. The first 6 participants were tested under fed (on C1D1) followed by fasted (on C2D1) conditions, the next 6 participants were tested under fasted (on C1D1) followed by fed (on C2D1) conditions. Only participants in PD 0332991 200 mg (14/21 days) and 125 mg (21/28 days) groups participated in food effect crossover and results are reported as per fed and fasted conditions. The high-fat meal was composed of around 800 to 1000 calories total, with fat composing around 50% of the total caloric content.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D1, C2D1|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
169107|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 14/21 Dose-Corrected to 125 mg: Multiple Dose|The mean Cmax for 200 mg dose group (dose corrected to 125 mg) on Cycle 1 Day 14 (C1D14) and 125 mg dose group on Cycle 1 Day 21 (C1D21) was calculated. Only participants from 125 mg and 200 mg dose groups were reported.|Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D21 for participants receiving 125 mg (21/28 Days) and Hour 0 (pre-dose), 1, 2, 4, 7, 10 and 24 hours post-dose on C1D14 for participants receiving 200 mg (14/21 Days)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
169108|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 8: Multiple Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 8 of Cycle 1 (C1D8)|PK analysis set included all participants from FAS who had completed PK blood sampling for at least one day. Here “N” (number of participants analyzed) signifies participant who were evaluable for this outcome measure.||ng/mL||Standard Deviation|Mean
169109|NCT00141297|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1: Single Dose||Hour 0 (pre-dose), 1, 2, 4, 7, and 10 hours post-dose on Day 1 of Cycle 1 (C1D1)|Pharmacokinetic (PK) analysis set included all participants from FAS who had completed PK blood sampling for at least one day.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
169110|NCT00141297|Primary|Number of Participants Who Died Due to Adverse Event on the Basis of Relatedness to Study Drug|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness [to study drug] was assessed by the investigator (Yes/No).|Baseline up to 30 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
169111|NCT00141297|Primary|Number of Participants With Treatment-Related Treatment Emergent Adverse Events|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
169229|NCT00140140|Primary|Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population||10^9/L||Standard Deviation|Mean
169112|NCT00141297|Primary|Number of Participants With Treatment Emergent Adverse Events Categorized by Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. For clinical description of nature (severity) of AEs, AEs were grades as: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; and Grade 5: death related to AE. AEs during Cycle 1 and AEs post Cycle 1 are reported separately.|Cycle 1, Cycle 2 up to 28 days after end of treatment (up to Cycle 93)|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
169113|NCT00141297|Primary|Number of Dose-Limiting Toxicities (DLTs) Categorized as Per the Nature|DLT is defined in Outcome Measure 1. Hematologic (Grade 4 [life-threatening or disabling]) and non-hematologic (Grade 3 [severe], 4 [life-threatening and disabling], 5 [resulting in death]) DLTs are reported separately. A single participant may experience more than one DLT. Both treatment-related and treatment-unrelated DLT events were reported for this outcome measure.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||DLTs|||Number
169114|NCT00141297|Primary|Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose Level (RP2D)|MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was <33%. Once MTD was determined, it was defined as RP2D. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||milligram|||Number
169115|NCT00141297|Primary|Maximum Administered Dose (MAD)|Three new evaluable participants were to be assessed at each new dose level. The minimum time that these participants were to be followed after starting treatment was 1 cycle (28 or 21 days) before a new dose level could be opened. If none of these 3 participants experienced a DLT, the next higher dose level was to be opened on that schedule. If 1 participant developed a DLT, 3 more evaluable participants were to be enrolled at that dose level; if none of these additional 3 participants developed a DLT, the next higher dose level was to be opened on that schedule. If >=2 participants experienced a first cycle DLT at the same dose level and schedule, that dose level was to be defined as the MAD for that schedule. No additional participants were to be entered at the MAD for that dosing schedule. DLT is defined in Outcome Measure 1.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||milligram|||Number
169116|NCT00141297|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|DLT: an adverse event occurring after initiation of PD 0332991 that met any following criteria: 1) Grade 4 hematologic toxicity (platelets less than [<] 25000 per microliter (mcL), absolute neutrophil count [ANC] <500/mcL, hemoglobin [Hb] <6.5 gram per deciliter [g/dL]; 2) ANC <1000/mcL associated with documented infection or fever greater than or equal to (>=) 38.5 degrees Celsius; 3) >=Grade 3 non-hematologic treatment-related toxicity. In an asymptomatic participant, Grade 3 corrected QT (QTc) prolongation (>500 millisecond) (only if persisted with repeat testing and after correction of reversible causes [electrolyte abnormalities or hypoxia]); and 4) Inability to receive next dose of PD 0332991 within 1 week (+/-1 day) of last dose due to lack of hematologic recovery (platelets <50000/mcL, ANC <1000/mcL, and Hb <8.0 g/dL) or due to prolonged non-hematologic toxicities of >=Grade 3 severity. Occurrence of a DLT necessitated immediate interruption of scheduled study treatment.|Baseline up to 28 days|FAS included all enrolled participants who received at least one dose of study medication.||participants|||Number
169117|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
169118|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
169119|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
169120|NCT00141271|Secondary|Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6||Words||Standard Error|Least Squares Mean
169121|NCT00141271|Secondary|Change in Tower of London Test at Endpoint|Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Number Correct||Standard Error|Least Squares Mean
169122|NCT00141271|Secondary|Change in Symbol Coding at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||Total Correct||Standard Error|Least Squares Mean
169126|NCT00141271|Secondary|Change in Digit Sequencing Task at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases||Number Correct||Standard Error|Least Squares Mean
169127|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
169128|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
169129|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases||words||Standard Error|Least Squares Mean
169130|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall|Baseline to Week 6 LOCF|Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
169131|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
169132|NCT00141271|Secondary|Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
169133|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases||words||Standard Error|Least Squares Mean
169134|NCT00141271|Secondary|Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.|Baseline to 6 Weeks LOCF|Intent to treat (ITT) population observed cases||words||Standard Error|Least Squares Mean
169135|NCT00141271|Secondary|Change in Verbal Memory Trial Performance Total Score at Endpoint|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall.|Baseline to 6 Weeks LOCF|Intent to Treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||words||Standard Error|Least Squares Mean
169136|NCT00141271|Secondary|Change in Sleep Disturbance Factor Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12.|Baseline to 6 weeks|ITT Population Observed cases||score on scale||Standard Error|Least Squares Mean
169137|NCT00141271|Secondary|Change in Retardation Factor Scores|Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16.|Baseline to 6 Weeks|||score on scale||Standard Error|Least Squares Mean
169138|NCT00141271|Secondary|Change in Anxiety/Somatizations Factor Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed Cases||score on scale||Standard Error|Least Squares Mean
169139|NCT00141271|Secondary|Change in Bech Melancholia Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.|Baseline to 6 Weeks|ITT Population Observed cases||score on scale||Standard Error|Least Squares Mean
169252|NCT00139737|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Baseline up to 72 months|Safety Analysis Set = All subjects who took at least 1 dose of study drug||Participants|||Number
169140|NCT00141271|Secondary|Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint|Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80|Baseline to 6 Weeks|ITT Population Observed Cases.n= 142, 137, 139; number of subjects who responded to the scale. Endpoint is LOCF endpoint among Week 1 through Week 6.||score on scale||Standard Error|Least Squares Mean
169141|NCT00141271|Secondary|Change in Sheehan Disability Scale (SDS) Total Score at Endpoint|Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30.|Baseline to Week 6|ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 - 6; n= 128, 126, 128; number of subjects who responded to the scale.||score on scale||Standard Error|Least Squares Mean
169142|NCT00141271|Secondary|Response as Measured by CGI-I Score Less Than or Equal to 2|Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Week 1 through Week 6 (endpoint)|"ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.~Not all subjects answered each week."||Participants|||Number
169143|NCT00141271|Secondary|Change in Total Score in Hamilton Depression (HAM-D 25)|Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.|Baseline to 6 Weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||score on scale||Standard Error|Least Squares Mean
169144|NCT00141271|Secondary|Change in Global Clinical Improvement of Symptoms (CGI -I)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse|Baseline to 6 weeks|ITT population Observed Cases||score on scale||Standard Error|Least Squares Mean
169145|NCT00141271|Secondary|Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill|Baseline to 6 weeks|ITT population Observed Cases||score on scale||Standard Error|Least Squares Mean
169146|NCT00141271|Secondary|Change in Total Score of Young Mania Rating Scale (YMRS)|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 0 to 4 for 7 items and 0 to 8 for 4 items; 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.|Baseline to 6 weeks|ITT Population||score on scale||Standard Error|Least Squares Mean
169147|NCT00141271|Secondary|Change in Hamilton Anxiety Rating (HAM-A)|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56.|Baseline to 6 weeks|ITT population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6||score on scale||Standard Error|Least Squares Mean
169148|NCT00141271|Secondary|Change in Hamilton Depression (HAM-D 17) Total Score|Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52.|Baseline to 6 weeks|ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.||score on scale||Standard Error|Least Squares Mean
169149|NCT00141271|Secondary|Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7|Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each week."||Participants|||Number
169150|NCT00141271|Secondary|Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12|Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)|Baseline to 6 weeks|"ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6;~Not all subjects answered each week."||participants|||Number
169151|NCT00141271|Secondary|Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)|Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality|Baseline, 6 Weeks LOCF|Intent to treat (ITT) population observed cases, Last Observation Carried Forward (LOCF).||score on scale||Standard Error|Least Squares Mean
169152|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score|Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each Week."||participants|||Number
169342|NCT00138424|Secondary|Percentage Change of Viral Load in Urine and Plasma BK Virus by Quantitative PCR Between Baseline and Each Visit|The percent change in viral load from baseline to day 7, day 21 and day 49 as measured in the urine and measured in the blood. A drop is identified by use of '-', an increase in viral load has no sign in front of the number.|Baseline, and each visit: day 7, 21, 35 and 49.|||Percent Change||Full Range|Median
169153|NCT00141271|Secondary|Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60|Baseline to 6 weeks|"Intent to treat (ITT) population observed cases.~Not all subjects answered at each Week"||Participants|||Number
169154|NCT00141271|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score|Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.|Baseline to 6 weeks|Intent to treat (ITT) population observed cases||score on scale||Standard Error|Least Squares Mean
169155|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 observations while on study medication were carried forward (LOCF).||score on scale||Standard Deviation|Mean
169156|NCT00141219|Secondary|Clinical Global Impression of Change (CGIC)|CGIC is a clinician-rated instrument that assesses the subject’s overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. CGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||participants|||Number
169157|NCT00141219|Secondary|Patient Global Impression of Change (PGIC)|PGIC is a subject-rated instrument that measured change in subject’s overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. PGIC was measured at Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||participants|||Number
169158|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Depression (HADS-D) Score|HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (“lowering of hedonic tone”). Score range = 0 to 21; higher scores indicate a greater intensity of depression|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169159|NCT00141219|Secondary|Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score|HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. HADS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169160|NCT00141219|Secondary|Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS)|EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) & Visual Analog Scale (VAS)). The VAS is designed to rate the subject’s current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169161|NCT00141219|Secondary|Euro Quality of Life (QOL) (EQ-5D) Utility Score|EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject’s level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. EQ-5D was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169162|NCT00141219|Secondary|Medical Outcome Study (MOS) Overall Sleep Problems Index|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169532|NCT00135330|Secondary|Change in Percent Body Fat During a Meal Challenge Test (MCT)|Change in percent body fat from baseline to week 20, as assessed during an MCT|20 weeks|All Patients in Full Analysis Set Who Have Both Baseline and Endpoint Measurement||percentage||Standard Error|Least Squares Mean
169163|NCT00141219|Secondary|Medical Outcome Study (MOS) Somnolence|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169164|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Adequacy|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169165|NCT00141219|Secondary|Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||participants|||Number
169166|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Quantity|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169167|NCT00141219|Secondary|Medical Outcome Study (MOS) Awaken Short of Breath or Headache|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from the analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169168|NCT00141219|Secondary|Medical Outcome Study (MOS) Snoring Score|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169169|NCT00141219|Secondary|Medical Outcome Study (MOS) Sleep Disturbance|MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.|Week 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. MOS was measured at baseline and Week 8. For subjects not completing the study, their final data were considered Week 8 data; those without final data were excluded from analysis.||score on scale||95% Confidence Interval|Least Squares Mean
169170|NCT00141219|Secondary|Mean Sleep Score as Computed by DSIS.|DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.|Weeks 1 to 8|ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n = (pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
169171|NCT00141219|Secondary|Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).|DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily sleep interference scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||score on scale||95% Confidence Interval|Least Squares Mean
169172|NCT00141219|Secondary|Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score|DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Subjects without any post-baseline daily pain scores would have no DAAC; missing DAACs were not imputed.||score on scale||95% Confidence Interval|Least Squares Mean
169533|NCT00135330|Secondary|Change in Fasting Triglycerides|Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set||mmol/L||Standard Error|Geometric Mean
169173|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score|DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.|Weeks 1 to 8|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. Missing Weekly mean scores were not imputed. Number of subjects analyzed differed by week; noted as n= (pregabalin, placebo).||score on scale||Standard Error|Least Squares Mean
169174|NCT00141219|Other Pre-specified|Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|"Evaluable (EVAL) Population: Subset of ITT subjects with ≥4 daily pain diaries in the 7 days before Visit 2 (randomization) with average score ≥4; ≥14 days of treatment; ≥14 days of DB daily pain diaries; not withdrawn due to Protocol violation or Did not meet entrance criteria; not previously participated in the study."||score on scale||95% Confidence Interval|Least Squares Mean
169175|NCT00141219|Primary|Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)|DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||score on scale||95% Confidence Interval|Least Squares Mean
169176|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.|Endpoint- Week 8 or Early Discontination|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||participants|||Number
169177|NCT00141219|Secondary|Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)|DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline|Endpoint- Week 8 or Early Discontinuation|The ITT population consisted of subjects who received ≥1 dose of study medication and had contributed to the analysis of any efficacy parameter. For subjects who did not complete the study, the last 7 available daily pain scores while on study medication were carried forward (LOCF) to calculate the endpoint mean score.||participants|||Number
169178|NCT00141102|Other Pre-specified|Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.||participants|||Number
169179|NCT00141102|Other Pre-specified|Number of Subjects Alive at the Post Trial Interview|Interview occurred via telephone to obtain follow-up mortality and hospitalization information.|6 months following last dose|Safety population. Number of participants analyzed = number of subjects with follow-up information available.||participants|||Number
169180|NCT00141102|Secondary|Change From Baseline in C-Reactive Protein to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||mg/dL||Standard Error|Least Squares Mean
169181|NCT00141102|Secondary|Change From Baseline in Ferretin to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||ug/dL||Standard Error|Least Squares Mean
169182|NCT00141102|Secondary|Change From Baseline in Iron Binding Capacity to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||microgram (ug)/dL||Standard Error|Least Squares Mean
169183|NCT00141102|Secondary|Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET||Month 6/ET|Safety population. Number of participants analyzed = number of subjects with analyzable data.||IU/L||Standard Error|Least Squares Mean
169184|NCT00141102|Secondary|Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)|GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.|6 month treatment duration|Safety population. Number of participants analyzed = number of subjects with analyzable data.||participants|||Number
169185|NCT00141102|Secondary|Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin|A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.|6 month treatment duration|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.||participants|||Number
169186|NCT00141102|Secondary|Change From Baseline in Hematocrit at Month 6/ET||Month 6/ET|Safety population. Number of Participants Analyzed = number of subjects with analyzable data.||percent||Standard Error|Least Squares Mean
169187|NCT00141102|Secondary|Change From Baseline in Hemoglobin at Month 6/ET||Month 6/ET|Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data.||grams (g)/deciliter (dL)||Standard Error|Least Squares Mean
169188|NCT00141102|Secondary|Number of Subjects Withdrawn Due to GI Adverse Events (AEs)|GI AEs were defined using MedDRA SOC “Gastrointestinal Disorders” but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.|6 month treatment duration|ITT||participants|||Number
169190|NCT00141102|Secondary|Number of Subjects With CSULGIEs by History of GD Ulceration|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|ITT. n = number of subjects who had history or no history of GD ulceration.||participants|||Number
169191|NCT00141102|Secondary|Number of Subjects With SUs|Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT.||participants|||Number
169192|NCT00141102|Secondary|Change From Baseline in Patient’s Global Arthritis Assessment at Month 6/Early Termination (ET)|Subjects rated response to question: “Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?” using a 1 to 5 grading scale where 1=very good and 5=very poor.|Month 6/Early Termination (ET)|ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used.||scores on a scale||Standard Error|Least Squares Mean
169193|NCT00141102|Secondary|Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)|CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.|6 month treatment duration|ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee.||participants|||Number
169194|NCT00141102|Primary|Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)|CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.|6 month treatment duration|Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.||participants|||Number
169195|NCT00141037|Primary|Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation|"Biopsy-proven acute renal (kidney) rejection [1, 2].~Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection[2]~Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999"|Up to one year post kidney transplantation procedure|All Enrolled Subjects||Rejection Events||95% Confidence Interval|Number
169196|NCT00141037|Primary|The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation|Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free|One year post kidney transplantation procedure|All Enrolled Subjects||Standard Deviation Score (SDS)||Standard Deviation|Mean
169197|NCT00140842|Secondary|Visceral Adipose Tissue|Visceral adipose tissue was measured using magnetic resonance imaging at the level of the fourth lumbar vertebra (L4)|Baseline|The analysis was completed on the 30 participants as per protocol||grams||Standard Deviation|Mean
169198|NCT00140842|Primary|Peak Growth Hormone (GH) on the GH Stimulation Test|Peak growth hormone (GH) on the GH stimulation test is a measure of the adequacy of GH secretion.|Baseline|This was a cross-sectional study to compare differences in growth hormone (GH) secretory status in relation to body composition in obese versus normal-weight girls. This was a pilot study and the analysis was performed using a Student t-test to compare means across groups||ng/ml||Standard Deviation|Mean
169199|NCT00140621|Primary|Change From Baseline in LVM at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.||gm||95% Confidence Interval|Least Squares Mean
169200|NCT00140621|Primary|Percent Change From Baseline in Left Ventricular Mass (LVM) at Week 156|Left ventricular mass was assessed by echocardiogram.|Baseline to Week 156|EEP.||percent change||95% Confidence Interval|Least Squares Mean
169201|NCT00140621|Secondary|Change From Baseline in Short Form (36) Health Survey (SF-36) Scores at Week 156|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 156|EEP.||units on a scale||Standard Deviation|Mean
169202|NCT00140621|Secondary|Percent Change From Baseline in GL-3 Plasma Levels at Week 156||Baseline to Week 156|EEP.||percent change||95% Confidence Interval|Least Squares Mean
169217|NCT00140426|Secondary|Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC)|"The Multidimensional Anxiety Scale for Children (MASC) is a self report measure completed by the subject that measures anxiety symptoms.~Higher scores indicate greater anxiety. A score of over 50 is significant for anxiety~Change in MASC scores was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly to study end point|||units on a scale||Standard Deviation|Mean
169203|NCT00140621|Secondary|Number of Participants in Overall Cardiac Function Assessment and Clinical Symptoms at Week 156: Change From Baseline in Cardiac Function Test|Overall cardiac function assessment was assessed by tests (echocardiogram,cardiac catheterization (optional),electrocardiogram,B-type natriuretic peptide [BNP]), clinical symptoms (subjective symptoms) and the New York Heart Association (NYHA) cardiac functional classification.Overall assessment of cardiac function was assessed based on the evaluation items including interventricular septum thickness, left ventricular posterior wall thickness, left ventricular mass, clinical function tests and clinical symptoms. A subject was considered to be Improved: if Improved in 2 items or more, Unchanged: Improved in one item and unchanged in 2 items or unchanged in all 3 items, Aggravated: Aggravated in one item or more.|Baseline to Week 156|EEP.||participants|||Number
169204|NCT00140621|Primary|Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.||mm||95% Confidence Interval|Least Squares Mean
169205|NCT00140621|Primary|Percent Change From Baseline in Interventricular Septum and Left Ventricular Posterior Wall Thickness at Week 156|Interventricular septum and left ventricular posterior wall thickness was assessed by echocardiogram.|Baseline to Week 156|EEP.||percent change||95% Confidence Interval|Least Squares Mean
169206|NCT00140556|Secondary|Failure Free Survival||3 yrs||||||
169207|NCT00140556|Secondary|Local Regional Control||1 yr following chemoradiation||||||
169208|NCT00140556|Primary|Tumor Resolution|Complete response (resolution) of tumor on clinical exam.|Within 30 days of completing RT|2 participants had occult primaries, thus were not included in clinical complete response||Participants|||Number
169209|NCT00140426|Primary|Body Image Software (BIS) - Difference Limen (DL)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS-DL was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. Interpreting the DL occurs by referencing it to DL= 0, which would reflect a total inability to detect size differences, which has never occurred in studies using the BIS program."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.||units on a scale||Standard Deviation|Mean
169210|NCT00140426|Primary|Body Image Software (BIS) - Point of Subjective Equality (PSE)|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS -PSE was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. Interpreting the PSE is how it compares to a PSE = 0, which is no distortion in body size."|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.||units on a scale||Standard Deviation|Mean
169211|NCT00140426|Primary|Body Image Software (BIS): Average Desired Thinness|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image. The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent their desired image. Accuracy is measured by a smaller score between desired image and actual image.~Change in BIS - Average Desired Thinness score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. . There are no subscales."|monthly|Many patients did not complete this outcome measurement. Change from baseline to end of study were compared between arms.||units on a scale||Standard Deviation|Mean
169212|NCT00140426|Primary|Body Image Software (BIS): Average Distortion|"Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer using the direction to adjust their image to how they see themselves right now, this determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.~Change in the BIS Average Distortion score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.~There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. The BIS program calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of how they see themselves right now"|monthly|Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.||units on a scale||Standard Deviation|Mean
169213|NCT00140426|Primary|Color A Person Test (CAPT)|"Color A Person Test (CAPT) - Subjects color an outlined image of a body to indicate body dissatisfaction (red (5)= very dissatisfied, Yellow, dissatisfied, black, neutral, green satisfied, blue very satisfied (1). The outline is divided into16 sections for scoring. The CAPT was completed at baseline and monthly during study participation.~Total CAPT scores were calculated by adding the total score and dividing by 16. Score range is 1-5. Lower scores indicate less body dissatisfaction.~Change in the CAPT score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly|||units on a scale||Standard Deviation|Mean
169214|NCT00140426|Secondary|Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study|The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities.|0 - 18 weeks|||weeks||Standard Error|Mean
169215|NCT00140426|Secondary|Change in Prolactin Levels|Prolactin serum blood levels, measured in nanograms / ml|week 0 and week 7|||ng/ml||Standard Deviation|Mean
169216|NCT00140426|Secondary|Change in Leptin Levels|Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml).|Week 0 and week 7|||ng/ml||Standard Deviation|Mean
169534|NCT00135330|Secondary|Change in Fasting LDL Cholesterol|Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
169219|NCT00140426|Primary|Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior)|"The Ease of Eating Scale (EOES) is a 14 item scale which measures Food avoidance behaviors (FABs). The scale is rated by staff observing a subject eating a meal or snack. 0 = normal eating behavior, maximum score 28.~Higher scores indicate more food avoidance behaviors, such as taking small bites, taking > 30 seconds between bites (slow eating), etc.~EOE was completed for each meal a subject ate in the program and scores were averaged for each week in the study and entered in the data base.~Change in EOES score was calculated by evaluating change over time. This measure was only used in Phase 1 of the study, for days the subjects were in the treatment program."|weekly up to study endpoint: reaching target weight and maintaining for 1 month|2 patients in the placebo group were treated as inpatients and had no EOE data.||hazard ratio||95% Confidence Interval|Number
169220|NCT00140426|Primary|Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD)|"change in Eating Disorder Inventory (EDI) 2-score for Body Dissatisfaction (BD).~Lower scores are better on this scale. Higher scores indicate the subject has greater body dissatisfaction. BD is one of the 8 subscales of the EDI-2. 9 of the 91 questions in the EDI-2 scale constitute this subscale. The score range is 0-27. Subjects completed the EDI-2 at baseline and monthly during study participation (range 0 to 18 weeks). Change in the BD subscale score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|monthly|1 risperidone subject was missing data for BD at this data point.||units on a scale||Standard Deviation|Mean
169221|NCT00140426|Primary|Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT)|"Eating Disorder Inventory -2 - Subscale : Drive for Thinness Subscale (DT). Lower scores are better on this scale and indicate less cognitive focus on drive for thinness.~The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). The DT subscale was used for this outcome. Respondents rate each item as usually , often, sometimes, rarely or never. Subscale scores are computed by summing all item scores for each subscale. There are 7 items in the DT subscale (questions 1,7,11,16,25,32 and 49). the subscale score range is 0-21. The EDI-2 was completed by subjects at baseline and then monthly during study participation (range 0 -18 weeks). Change in the DT subscale score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points."|month|||units on a scale||Standard Deviation|Mean
169222|NCT00140413|Primary|Change in Anthropometric Measures Over Time|Primary outcome measures included change in stature, weight, BMI, and weight-for-stature z-scores over the course of the study. Z-score indicates how many standard deviations an element is from the mean. It is calculated as z = (x – µ) σ, where µ is the mean of the population, and σ is the standard deviation of the population. A positive z-score indicates a datum above the mean, while a negative z-score indicates a datum below the mean. All z-scores were obtained using Epi Info ™ 3.5.4. (Centers for Disease Control, Atlanta, GA).|Baseline and 36 months|||Z-score||Inter-Quartile Range|Median
169223|NCT00140140|Secondary|Kaplan-Meier Estimates for Participant Survival|Participant survival is the time from the first dose of study drug to participant death from any cause. Participants that did not die were censored at the last known time the participant was alive.|up to 39 months|Treated population||months||95% Confidence Interval|Median
169224|NCT00140140|Secondary|Kaplan Meier Estimate for Progression-Free Survival (PFS)|"PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Because no patients died as a result of a non-disease progression event, the analysis of PFS was identical to the analysis for TTP."|up to month 30|Treated population of participants who had disease progression or who died||months||95% Confidence Interval|Median
169225|NCT00140140|Secondary|Kaplan-Meier Estimate for Duration of Response|"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Complete response (CR) and partial response (PR) are defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated participants who had a response||months||95% Confidence Interval|Median
169226|NCT00140140|Secondary|Kaplan Meier Estimate for Time to Disease Progression (TTP)|"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion."|up to month 30|Treated population of participants with disease progression||months||95% Confidence Interval|Median
169227|NCT00140140|Secondary|Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #1 for definitions of CR and PR.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|up to month 30|Treated population||percentage of participants|||Number
169228|NCT00140140|Primary|Nadir Measurement for Hemoglobin (Hgb)|Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment.|up to week 129 (longest treatment)|Treated population||g/L||Standard Deviation|Mean
171565|NCT00113386|Primary|Comparison of Overall Survival||Date of death or date of last follow-up|This study terminated early with 19 out of 574 subjects accrued. Therefore no analysis was performed.|||||
169230|NCT00140140|Primary|Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)|"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) blood counts were graded using NCI CTCAE version 3.~ANC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal – 1.5*10^9/L; Grade 2 = <1.5 - 1.0*10^9/L; Grade 3 = <1.0 - 0.5*10^9/L; Grade 4 = <0.5*10^9/L~WBC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 – 1.0*10^9/L; Grade 4 = <1.0*10^9/L~Platelets:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 – 25.0*10^9/L; Grade 4 = <25.0*10^9/L~Hemoglobin:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal – 100 g/L ; Grade 2 = <100 – 80 g/L; Grade 3 = <80 – 65 g/L; Grade 4 = <65 g/L"|up to week 129 (longest treatment)|Treated population||participants|||Number
169231|NCT00140140|Primary|Percentage of Participants With Discontinued, Delayed or Interrupted Therapy|Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events.|up to week 129|Treated population||percentage of participants|||Number
169232|NCT00140140|Primary|Participants With Dose Limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Any drug-related toxicities CTC Grade 3 or higher were considered dose limiting. Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death. Other conditions considered dose-limiting toxicities include:~requirement of a dose adjustment during the first 4 weeks~a dose delay of >3 weeks during the first 4 weeks Grade 3 or greater toxicities attributed to the use of Herceptin were not considered dose-limiting toxicities.~The optimal tolerated dose of ABI-007 and vinorelbine given concurrently was defined as the dose administered in the absence of DLTs."|up to month 1|Treated population||participants|||Number
169233|NCT00140140|Primary|Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|"Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation.~Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|up to month 30|Treated population||percentage of participants||95% Confidence Interval|Number
169234|NCT00139997|Secondary|SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly following randomization|These participants are analyzed ITT- last observation carried forward.||units on a scale||Standard Deviation|Mean
169235|NCT00139997|Primary|Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.~Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization"|Week 4|These participants are analyzed ITT- last observation carried forward.||Percentage of SIGH SAD||Standard Deviation|Mean
169236|NCT00139776|Other Pre-specified|Serious Adverse Events in Open Label run-in Period|Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily|2 weeks prior to double blind dosing|1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.||participants|||Number
169237|NCT00139776|Other Pre-specified|Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments|SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)"||scores on a scale||Standard Deviation|Mean
169238|NCT00139776|Other Pre-specified|Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep|Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||participants|||Number
169343|NCT00138424|Secondary|The Effect of Cidofovir on BK Virus Determined by Percentage of Subjects Achieving an Undetectable BK Virus in Urine and Plasma PCR|The outcome measure is the percent of subjects that achieved non-detectable BK virus in the urine and plasma polymerase chain reaction (PCR) at day 35 after staring study drug. Undetectable is a PCR viral load of less than 200.|Day 35.|Percentage of subjects||percentage of subjects|||Number
169239|NCT00139776|Secondary|Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424"||scores on a scale * weeks||Standard Deviation|Mean
169240|NCT00139776|Other Pre-specified|Change in Medical Outcomes Study Sleep Scale - All Assessments|Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.|Period III|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)||scores on a scale||Standard Deviation|Mean
169241|NCT00139776|Secondary|Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores|Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424||scores on a scale||Standard Error|Least Squares Mean
169242|NCT00139776|Secondary|Days on Flare Medication|Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects who did not take flare medication were calculated as 0 and included in the analysis.~Number of subjects taking flare medication: continuous use n=282; intermittent use n=339."||days on medication per month per subject||Standard Deviation|Mean
169243|NCT00139776|Secondary|Proportion of Days on Rescue Medication|Days on rescue medication divided by number of days on study medication in Period III|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.~Subjects who did not take rescue medication were calculated as 0 and included in the analysis."||proportion of days||Standard Deviation|Mean
169244|NCT00139776|Secondary|Total Rescue Medication Taken (Mean)|Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant|Period III (22 weeks)|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~Subjects who did not take rescue medication were assumed to have taken 0mg and were included in the analysis.~Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239."||mg taken per month per participant||Standard Deviation|Mean
169245|NCT00139776|Secondary|Physician's Global Assessment of Arthritis at Final Visit|Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||participants|||Number
169246|NCT00139776|Secondary|Patient's Global Assessment of Arthritis|"Participant's response to question Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today? on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III."|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."||scores on a scale * weeks||Standard Error|Least Squares Mean
169247|NCT00139776|Secondary|Arthritis Pain Numerical Rating Scale (NRS)|Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.|Period III|"Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.~These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II."||scores on a scale * weeks||Standard Error|Least Squares Mean
169248|NCT00139776|Secondary|Proportion of Days in Osteoarthritis (OA) Flare|Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|||proportion of days in OA flare||Standard Deviation|Mean
169249|NCT00139776|Secondary|Proportion of Days Free From Osteoarthritis (OA) Flare|Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||proportion of days free from OA flare||Standard Deviation|Mean
169250|NCT00139776|Secondary|Time to Occurrence of First Osteoarthritis (OA) Flare|Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.||days||95% Confidence Interval|Median
169251|NCT00139776|Primary|Number of Flare Events Per Time of Exposure to Study Medication|Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.|Period III (22 weeks)|Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication||flare events per month||Standard Deviation|Mean
169253|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||mL/min/mmHg||Standard Deviation|Mean
169254|NCT00139659|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.|Baseline through Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS): all subjects who were randomized, had a baseline post-albuterol pulmonary function test (PFT) measurement, and had at least two post-baseline, post-albuterol PFT measurements. LOCF: last observation carried forward.||liters||Standard Deviation|Mean
169255|NCT00139659|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); blood glucose measurement was ≤ 49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Crude event rate = number of events divided by 100 subject-months. Subject months = elapsed number of months subject was in study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS). Due the small number of events severe hypoglycemic event rates were assessed per 100 months.||Number of events/100 subject-months.|||Number
169256|NCT00139659|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate = total events divided by subject months. Subject months = elapsed number of months a subject was in the study in each time interval.|0 to 1 month to 11 to 12 months, and Overall|Full analysis set (FAS)||events / subject-months|||Number
169257|NCT00139659|Secondary|Lipids: Median Change From Baseline to Last Observation|Lipids: median changes (milligrams per deciliter [mg/dL]) from Baseline median to last observation in cholesterol (random), triglycerides (random), high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. Normalized data was used in the computations. Last observation = last observation while on study drug or during the lag. Measures of dispersion for median changes in lipids were not determined.|Baseline to Last Observation|Primary analysis set (PAS); median change from Baseline to last observation. Last observation was defined as last observation while on study drug or during the lag. Full range (-999 to 999) was not calculated.||mg/dL|||Number
169258|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (units divided by kg). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg/kg, units/kg||Standard Deviation|Mean
169259|NCT00139659|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Average Total Daily Insulin Dose: short-acting insulin (milligrams [mg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg, units||Standard Deviation|Mean
169260|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|"Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg/kg. Subcutaneous Insulin reported in units/kg."|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg/kg, units/kg||Standard Deviation|Mean
169261|NCT00139659|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|"Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight: long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.~Inhaled Insulin reported in mg. Subcutaneous Insulin reported in units."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52|Primary analysis set (PAS)||mg, units||Standard Deviation|Mean
169262|NCT00139659|Secondary|Body Weight: Mean Baseline and Change From Baseline|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus baseline value.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS)||kilograms||Standard Deviation|Mean
169263|NCT00139659|Secondary|Fasting Plasma Glucose|Fasting plasma glucose (milligrams per deciliter [mg/dL]) at Baseline, and change from Baseline. Change from baseline: mean of value of fasting plasma glucose in mg/dL at observation minus baseline value.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Primary analysis set (PAS); Last Observation Carried Forward: if the end of study value was missing the last available observation for that subject was used..||mg/dL||Standard Deviation|Mean
169264|NCT00139659|Secondary|Glycosylated Hemoglobin (HbA1c)|Glycosylated Hemoglobin (HbA1c): observed mean values at Baseline and each observation, and change from Baseline. Change from Baseline = mean HbA1c at observation minus mean HbA1c at Baseline.|Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS)||percent||Standard Deviation|Mean
169344|NCT00138424|Primary|Safety and Tolerability of Cidofovir Assessed by Enumeration of Adverse Events Per Subject|The measure is the number of adverse events (ie: events that are change from baseline)experienced by subjects. The median or average number of events and the range of events across all subjects is reported.|Baseline through day 49|||Event||Full Range|Median
169265|NCT00139659|Secondary|Transition Dyspnea Index (TDI): Change in Total Score|Transition Dyspnea Index total score = sum of the numeric grades from the three dyspnea index questions: Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort. Rating scale: -3 (major deterioration), -2 (moderate deterioration), -1 (minor deterioration, 0 (no change), +1 (minor improvement), +2 (moderate improvement), +3 (major improvement).|Week 4, Week 12, Week 26, Week 39, Week 52|Full analysis set (FAS)||scores on scale||Standard Deviation|Mean
169266|NCT00139659|Secondary|Baseline Dyspnea Index (BDI)|Total score = the sum of the numeric grades from the three dyspnea index questions. Functional Impairment rating scale: Grade 4 (no impairment) to Grade 0 (very severe impairment); Magnitude of Task rating scale: Grade 4 (extraordinary) to Grade 0 (no task); and Magnitude of Effort rating scale: Grade 4 (extraordinary) to grade 0 (no effort).|run-in period|Full analysis set (FAS)||scores on scale||Standard Deviation|Mean
169267|NCT00139659|Secondary|Asthma Control as Measured by the Asthma Control Questionnaire©|Asthma Control Questionnaire©: 6 self-administered questions that assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; 7-point ordinal rating scale from 0 (good control) to 6 (poor control). A seventh question was completed by a health professional on forced expiratory volume in 1 second (FEV1) % predicted using a one-week recall period; scale: 0 (>95% predicted) to 6 (<50% predicted). Overall score = mean of questions 1 - 7.|Baseline, Weeks 4, 12, 26, 39, 52|FAS; abbreviations: Eval = evaluations, BL = Baseline.||scores on scale||Standard Deviation|Mean
169268|NCT00139659|Primary|Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS).||ml/min/mmHg/yr||Standard Error|Mean
169269|NCT00139659|Secondary|Number of Systemic Corticosteroid Rescues|Number of subjects who used a systemic corticosteroid at any time during the study, and the total number of systemic corticosteroid rescues. New rescue event = >=2 consecutive days between the end of one event and the start of another event.|Baseline through Week 52|Full analysis set (FAS); number of subjects with systemic corticosteroid rescues = inhaled insulin: 12, and subcutaneous insulin: 14. Due to inconsistencies in data entry, the numbers of systemic corticosteroid rescues were not considered entirely accurate.||systemic corticosteriod rescues|||Number
169270|NCT00139659|Secondary|Incidence of Severe Asthma Exacerbations|Severe asthma exacerbation was defined as one of the following: subject received oral (systemic) corticosteriods for the treatment of asthma; or subject had an unscheduled visit to a physician, emergency room, or hospital for the treatment of asthma. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months * 100.|0 to 1 Week to > 12 Months|Full analysis set (FAS); due to inconsistencies in data entry for systemic steroids, the protocol definition for severe asthma exacerbations, which was based on systemic corticosteroid use for asthma, could not be accurately assessed. Due the small number of events the incidence of severe asthma exacerbations was assessed per 100 months.||events/subject months*100|||Number
169271|NCT00139659|Secondary|Incidence of Non-severe Asthma Exacerbations|Non-severe asthma exacerbation = one of the following: any home monitored morning (4:45 am - 10:15 am) forced expiratory volume in 1 second (FEV1) <80% of the morning baseline for 2 or more consecutive days; or home monitored FEV1 <60% of Baseline at any time. Percent of Baseline = 100*(daily FEV1)/Baseline weekly FEV1. Subject-months=elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject-months.|0 to 1 week to > 12 months|FAS; review of source data for this endpoint showed excessive data variability for home-monitored FEV1 with outliers ranging from 0.01 to >100, and many subjects with random peaks and dips of 100% or more of their baseline. It is unlikely that the protocol definition is robust enough to provide real information about exacerbation frequencies.||events/subject-months|||Number
169272|NCT00139659|Secondary|Mean Weekly Asthma Symptom Scores|Mean weekly asthma symptom scores: subjects recorded their asthma symptom scores in an electronic symptom diary twice daily throughout the study, immediately upon awakening (5-10 AM) and in the evening or at bedtime (7-12 PM). Questions included extent of albuterol use, symptoms of wheezing, coughing, activity limitations and sleep; scale 0 (none/fine) to 3 (severe/ continuous/bad night).|Baseline through end of study|Data for mean weekly asthma symptom scores were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.||scores on scale||Standard Deviation|Mean
169273|NCT00139659|Secondary|Step Classification of Asthma Severity by Medication Usage|Step classification of asthma severity by medication usage. Subjects were classified at each visit according to the medication used on the day of the particular time-point; Step 1: intermittent asthma, Step 2: mild persistent asthma, Step 3: moderate persistent asthma, Step 4: severe persistent asthma. The number (%) of subjects in each step classification were provided at each assessment timepoint with a shift table indicating the number (%) of subjects moving from each step classification at each time-point.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for step classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.||subjects|||Number
169274|NCT00139659|Secondary|Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage|All asthma medication changes during the study were classified as step-up or step-down according to treatment guidelines. Step 1: Intermittant Asthma; Step 2: Mild Persistent Asthma; Step 3: Moderate Persistent Asthma; Step 4: Severe Persistent Asthma. The number of subjects in each step classification of asthma severity were provided at each assessment timepoint for each treatment group, with a shift table indicating the number of subjects moving from each step classification at each timepoint.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58|Data for the number of step-up and step-down changes in classification of asthma severity by medication usage were not tabulated or analyzed as accurate dose information data for all concomitant medications were not available due to inconsistencies in the way concomitant medication data were collected.||subjects|||Number
169345|NCT00138203|Secondary|Toxicity||From first dose of treatment until 30 days from the last dose of treatment||||||
169275|NCT00139659|Secondary|Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)|All subjects used an electronic symptom diary to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol) daily, immediately upon arising, and again in the evening or before bed.|Daily: Baseline to end of study|Mean weekly number of puffs of albuterol was not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.||number of puffs||Standard Deviation|Mean
169276|NCT00139659|Secondary|Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)|Subjects measured peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) twice daily and entered the results in an electronic diary. Daily data were used to calculate the mean PEFR and FEV1 for each week (observed weekly mean and change from baseline in weekly mean). For each subject, the mean weekly morning (and evening) PEFR and FEV1 was defined as the sum of the daily morning (and evening) PEFR (and FEV1) measurements during the week divided by the number of non-missing PEFR (and FEV1) measurements during the week.|Week -3 through Week 52|Mean weekly morning and evening peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1) were not presented due to lack of resource resulting from scaling down of Exubera® (inhaled insulin) development.||liters||Standard Deviation|Mean
169277|NCT00139659|Secondary|Methacholine Challenge|Methacholine Challange: performed on a subset of subjects using the 5-breath dosimeter method. Subjects were challenged with ascending doses of nebulized methacholine; dosing schedule: 0.03, 0.06, 0.12, 0.25, 0.5, 1.0, 2.0, 4.0, 8.0, 16.0, 32.0 milligrams per milliliter (mg/ml) administered in 5-minute intervals. Forced expiratory volume in 1 second (FEV1) was measured 1-3 minutes after each inhalation of methacholine solution. Testing continued until highest FEV1 decreased by ≥20% from the challenge (post-diluent) reference, or until completion all doses.|1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5)|There were no methacholine challenges performed in subjects using inhaled insulin due to protocol-defined exclusion criteria for methacholine challenge testing, and methacholine provocative concentration [of methacholine] causing a 20% fall in FEV1 (PC20) data were not analyzed.||liters||Standard Deviation|Mean
169278|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Carbon Monoxide Diffusing Capacity (DLco) dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin was defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value.|Baseline, Week 9, Week 51|Full analysis set (FAS)||ml/min/mmHg||Standard Deviation|Mean
169279|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in 10 Minute and 60 Minute post-insulin forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in FEV1 measured in liters (L) 10 and 60 Minutes post-insulin. Percent change = (value at observation minus Baseline value) divided by Baseline value *100%.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||percent||Standard Deviation|Mean
169280|NCT00139659|Secondary|Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin|Change from Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in one second (FEV1) measured 10 and 60 minutes after the first daily dose of insulin. Insulin dose responsiveness = the difference between FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post dose FEV1 value minus predose FEV1 value.|Baseline, Week 9, Week 51|Full analysis set (FAS)||liters||Standard Deviation|Mean
169281|NCT00139659|Secondary|Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)|Percent predicted change from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1) measured in liters (L): National Health and Nutrition Examination Survey (NHANES III) reference standard. Percent change from Baseline in post-bronchdilator FEV1 measured in liters (L): (observed value minus Baseline value) divided by Baseline value *100%.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||percentage of FEV1||Standard Deviation|Mean
169282|NCT00139659|Secondary|Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol|Responsiveness was the percent change from the forced expiratory volume in 1 second (FEV1) value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52|Full analysis set (FAS)||percent change in FEV1||Standard Deviation|Mean
169283|NCT00139659|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Change from baseline in Post-bronchodilator Forced Vital Capacity (FVC) measured in liters (L) 30 minutes following the administration of albuterol: change = FVC at observation minus FVC at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||liters||Standard Deviation|Mean
169284|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||ml/min/mmHg||Standard Deviation|Mean
169285|NCT00139659|Secondary|Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Insulin Forced Expiratory Volume in one second (FEV1) measured in liters (L): change = FEV1 at observation minus FEV1 at Baseline.|Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward|Full analysis set (FAS); LOCF: last observation carried forward.||liters||Standard Deviation|Mean
171933|NCT00110812|Primary|Mean Change in CD4+ T Lymphocyte Count|Change in CD4 count from baseline to week 32.|Week 32|patients for whom the week-32 CD4+ cell count was measured||cell/mm^3||Standard Deviation|Mean
169286|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)|Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg): change = DLco at observation minus DLco at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||ml/min/mmHg||Standard Deviation|Mean
169287|NCT00139659|Secondary|Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)|Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at each visit. FEV1 was measured in liters (L) before the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus mean baseline value.|Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)|Full analysis set (FAS); LOCF: last observation carried forward.||liters||Standard Error|Mean
169288|NCT00139659|Primary|Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)|Annualized rates of change (slope throughout time from baseline to end of study[visit]) for forced expiratory volume in 1 second (FEV1) (liters per year [L/yr]) measured 30 minutes following the administration of albuterol.|Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52|Primary analysis set (PAS): all subjects who were randomized, had no significant protocol violations, had baseline (BL) post-albuterol pulmonary function test (PFT) measurement, had at least 2 post-BL, post-albuterol PFT measurements with 1 measurement at least 6 months post-BL, and received study drug for at least 50% (154 days) of study duration.||L/yr||Standard Error|Mean
169289|NCT00139477|Primary|Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at 6 Months|Value at 6 months minus value at baseline. PAI-1 is the primary physiological inhibitor of fibrinolysis and proteolysis. High PAI-1 levels have been linked to thrombosis and fibrosis, insulin resistance and obesity. PAI-1 was measured by ELISA (American Diagnostica, Stamford, CT, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group and 1 Subject in the Diet/Exercise, then Diet/Exercise plus Metformin (Pubertal) Group did not have a PAI-1 level available for analysis."||ng/ML||Inter-Quartile Range|Median
169290|NCT00139477|Primary|Change From Baseline in Interleukin 6 (IL-6) at 6 Months|Value at 6 months minus value at baseline. IL-6 is a pro-inflammatory cytokine thought to produce a state of low-grade inflammation in obese individuals. IL-6 stimulates hepatic production of C-reactive protein (CRP), an acute phase protein which is a sensitive marker for systemic inflammation. IL-6 was measured by enzyme-linked immunosorbent assay (ELISA; R&D Systems, Minneapolis, MN, USA).|Baseline and 6 months|||pg/mL||Inter-Quartile Range|Median
169291|NCT00139477|Primary|Change From Baseline in Fibrinogen at 6 Months|Value at 6 months minus value at baseline. Fibrinogen is a hepatic-derived factor directly involved in clotting and in the viscosity characteristics of blood flow. It binds to platelets and contributes to their aggregation, promotes fibrin formation and is also an acute phase reactant that is increased in inflammatory states. Fibrinogen concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA).|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have a Fibrinogen level available for analysis."||mg/dL||Inter-Quartile Range|Median
169292|NCT00139477|Primary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at 6 Months|Value at 6 months minus value at baseline. HsCRP is an acute phase protein which is a sensitive marker for systemic inflammation. HsCRP concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA), with an hsCRP lower sensitivity of 0.156 mg/L.|Baseline and 6 months|"1 Subject in the Diet/Exercise plus Metformin, then Diet/Exercise (Pubertal) Group did not have an hsCRP level available for analysis."||mg/dL||Inter-Quartile Range|Median
169293|NCT00139477|Primary|Protocol #1: Serum Marker Levels Between Obese and Lean Children|This outcome measure is from Protocol #1 (a cross-sectional study); results are not posted.|Screening Visit||||||
169294|NCT00138671|Secondary|Severe Hypoglcyemic Event Rates|An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL or the blood glucose was not measured, but the clinical manifestations were reversed by oral carbohydrates, subcutaneous glucagon, or intravenous glucose. Crude event rate=total events/100 subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events / 100 subject-months|||Number
169295|NCT00138671|Secondary|Hypoglycemic Event Rates|A hypoglycemic event was identified by characteristic symptoms; blood glucose levels at 59 mg/dL (3.2 mmol/L) or less with a glucose check; or any glucose measurement 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Crude event rate=total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to1 month to > 11 months|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events / subject-month|||Number
169296|NCT00138671|Secondary|Lipids|Lipids collected: Total cholesterol, high-density lipoprotein, low-density lipoptrotein, and triglycerides. Lipids data were collected, but not analyzed.|Duration of the study|||mg/dL|||Number
169297|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Adjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin. Dose was adjusted for body weight (mg divided by kg or units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mg/kg, Units/kg||Standard Deviation|Mean
169346|NCT00138203|Secondary|Overall Survial|Overall survial of subjects from the start of treatment to the time of death|From treatment start to time of death|All subjects who were considered evaulable (received more than one treatment cycle) were included in this evaluation||months||Full Range|Median
169298|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Adjusted for Body Weight)|Intermediate/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups. Dose was adjusted for body weight (units divided by kg).|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||Units/kg||Standard Deviation|Mean
169299|NCT00138671|Secondary|Mean Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mg, Units||Standard Deviation|Mean
169300|NCT00138671|Secondary|Mean Total Daily Intermediate-/Long-Acting Insulin Dose (Unadjusted for Body Weight)|Intermediate-/long-acting insulin included Insulin NPH, Ultralente, and Insulin Glargine for both groups.|Weeks 1, 2, 3, 4, 6, 9, 12, 18, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||Units||Standard Deviation|Mean
169301|NCT00138671|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight in kilograms (kg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 9, 11, 12, 18, 26, 39, 50, 51, 52|FAS, HbA1c=randomized subjects with >=1 study drug dose, baseline and >=1 post-baseline HbA1c measurement. Last Observation Carried Forward (LOCF) method used. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin. Week 11 and 50 visits were part of the methacholine substudy and were not required visits for all subjects.||kg||Standard Deviation|Mean
169302|NCT00138671|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline: mean of (value of observed fasting plasma glucose in milligrams/deciliters (mg/dL) at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mg/dL||Standard Deviation|Mean
169303|NCT00138671|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c at treatment duration minus baseline value).|Baseline, Weeks 6, 12, 26, 39, and 52|FAS, HbA1c=all randomized subjects who received at least 1 dose of study treatment, had a baseline HbA1c measurement, and had at least 1 HbA1c post-baseline measurement. Week 52 Last Observation Carried Forward (LOCF)=subjects' last measurement carried forward. Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||percent||Standard Deviation|Mean
169304|NCT00138671|Secondary|Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) Questionnaires|The BDI and TDI measured or quantitated the severity of breathlessness (shortness of breath) in symptomatic subjects. BDI and TDI data were collected, but not analyzed.|Duration of the study|||grade|||Number
169305|NCT00138671|Secondary|Incidence of Severe COPD Exacerbations|Severe COPD exacerbation = a COPD-related hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events/subject-month (crude event rate)|||Number
169306|NCT00138671|Secondary|Incidence of Non-Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Non-severe COPD exacerbation = additional therapy (systemic corticosteroids, antibiotics, oxygen) needed for worsening respiratory symptoms and/or lung function, not needing hospitalization > 24 hours. Crude event rate = total events divided by subject-months. Subject-months=elapsed number of months a subject was in the study in each time interval.|0 to 1 week to > 9 months|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||events/subject-month (crude event rate)|||Number
169307|NCT00138671|Secondary|Mean Weekly Number of Puffs of Short-Acting Bronchodilator Used|All subjects used diary cards to record their daily use of short-acting bronchodilators. Subjects recorded the sum of their short-acting bronchodilator use (puffs of albuterol plus ipratropium plus Combivent®, as applicable) daily, immediately upon arising, and again in the evening or before bed. Mean weekly number of puffs of short-acting bronchodilator used data were collected, but not analyzed.|Duration of the study|||puffs|||Number
169308|NCT00138671|Secondary|Methacholine PC20|Methacholine challenge testing was conducted at selected sites at visits which did not occur at other sites (Weeks -2.9, -0.9, 11, 50 and 52+5). Methacholine challenge was not analyzed as there was only 1 test performed, which was a baseline test, and no methacholine tests performed in subjects using inhaled insulin.|Duration of the study|||mg/mL|||Number
169309|NCT00138671|Secondary|Insulin Dose Responsiveness for DLco|DLco dose responsivness 10 and 60 minutes after insulin. DLco dose-responsiveness to insulin (defined as the difference between the DLco value following a dose of insulin and DLco value before a dose of insulin, operationally defined as the post-dose DLco value minus pre-dose DLco value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had a FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mL/min/mmHg||Standard Deviation|Mean
169347|NCT00138203|Secondary|Time to Progression|Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|From start of treatment to progression (average was 3.7 months)|Subjects who were considered evaluable (received more than one treatment cycle) were included in these results.||months||Full Range|Median
169310|NCT00138671|Secondary|Insulin Dose Responsiveness for FEV1|FEV1 dose responsiveness 10 and 60 minutes after insulin. FEV1 dose-responsiveness to insulin (defined as the difference between the FEV1 value following a dose of insulin and FEV1 value before a dose of insulin, operationally defined as the post-dose FEV1 value minus pre-dose FEV1 value).|Baseline, Week 9, Week 51|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||L||Standard Deviation|Mean
169311|NCT00138671|Secondary|Bronchodilator Responsiveness as Determined by the Change in FEV1|Responsiveness was the percent change from the FEV1 value before bronchodilator use to the FEV1 value 30 minutes after bronchodilator use, operationally defined as [(post-bronchodilator FEV1 minus pre-bronchodilator FEV1 divided by pre-bronchodilator FEV1] multiplied by 100.|Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||percent change||Standard Deviation|Mean
169312|NCT00138671|Secondary|Other PFTs (Besides FEV1 and DLco)|Other PFTs (besides FEV1 and DLco) were measured 30 minutes following the administration of ipratropium. Other PFTs included forced vital capacity (FVC), peak expiratory flow rate (maximal forced expiratory flow) (PEFR[FEFmax]), and forced expiratory flow from 25% to 75% of vital capacity (FEF25%-75%). Other PFT data were collected, but not analyzed.|Duration of the study|||mL|||Number
169313|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusion Capacity (DLco)|DLco measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed DLco (mL/min/mmHg) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|FAS, FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||mL/min/mmHg||Standard Deviation|Mean
169314|NCT00138671|Secondary|Full PFTs (DLco, Pre-Ipratropium and Pre- Insulin PFTs)|Full PFTs included DLco pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study|||mL/min/mmHg|||Number
169315|NCT00138671|Secondary|Full Pulmonary Function Tests (PFTs) (Spirometry, Pre-Ipratropium and Pre-Insulin PFTs)|Full PFTs included spirometry pre- and 30-minutes post-ipratropium and were completed between the hours of 6 AM and 10 AM with subjects in the fasting state. Full PFT data were collected, but not analyzed.|Duration of the study|||L|||Number
169316|NCT00138671|Primary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was measured in liters (L) 30 minutes following the administration of ipratropium. Change from baseline: mean of (value of observed FEV1 (L) at treatment duration minus baseline value).|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18, 26, 39, 52|Full Analysis Set (FAS), FEV1=all randomized subjects who received at least 1 dose of study treatment, had a baseline FEV1 measurement (post-bronchodilator), and had at least 1 FEV1 post-baseline measurement (post-bronchodilator). Number of subjects with evaluable data: n=Inhaled Insulin, Subcutaneous Insulin.||L||Standard Deviation|Mean
169317|NCT00138658|Secondary|AUC-0-last|AUC-0-last is the area under the plasma concentration time curve from time 0 to the last last time point (23.5 hrs)|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011||ng*h/mL||Standard Deviation|Mean
169318|NCT00138658|Secondary|t1/2 of OGX-011|Plasma half life of OGX-011|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011||hours||Standard Deviation|Mean
169319|NCT00138658|Primary|Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen|"Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR).~The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles.~CR: disappearance of clinical/radiological evidence of tumor.~PR: >= 30% decrease in the sum of the longest diameter of target lesions.~SD: did not fulfill the criteria for CR or PR but not progressive disease."|Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.|The efficacy analysis included all 81 subjects that received at least one dose of OGX-011. Of the 25 subjects with CR or PR, 21 subjects had a confirmed response. The other 4 patients did not have confirmatory scans (n=3) or discontinued treatment (N=1).||percentage of participants|||Number
169320|NCT00138658|Secondary|Cmax of OGX-011|Cmax is a plasma pharmacokinetic parameter that is defined as the maximum observed concentration of drug substance in plasma.|Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.|Data are reported for the 6 subjects who received 640 mg OGX-011. This is the dose to be used in additional Phase 3 studies of OGX-011||ng/mL||Standard Deviation|Mean
169321|NCT00138658|Secondary|Effect of OGX-011 on Serum Clusterin Levels|To measure the effect of OGX-011 on serum clusterin levels. The drug substance, OGX-011, is an antisense product designed to bind to clusterin mRNA, resulting in the inhibition of the production of human clusterin protein. Therefore, serum clusterin levels were expected to decrease.|Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1|55 evaluable subjects had baseline value and at least one post-baseline serum clusterin assessment.||µg/mL||Standard Deviation|Mean
169322|NCT00138658|Secondary|Overall Survival|Overall survival was defined as time from date of first treatment with OGX-011 to the date of death from any cause. Overall survival was censored at date of last contact for subjects who were still alive at end of study.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of subjects who died (n=70); n=11 subjects were censored at end of study (10 were alive and 1 was lost to follow up)||months||95% Confidence Interval|Median
169323|NCT00138658|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as time from first treatment with OGX-011 to documented evidence of disease progression or date of death. For subjects without disease progression based on RECIST who initiated subsequent anti-cancer therapy, date of progression was defined as date of initiating new cancer treatment. PFS was censored as of the date of first OGX-011 dose for subjects who failed to return for assessments after screening. For subjects who were still alive and without progressive disease at the time of data cut-off, PFS was censored at date of last disease assessment.|All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.|Number of patients who progressed or died (n=75); data for 6 patients were censored. (PFS was censored at the date of the first dose of OGX-011 for subjects who failed to return for any disease assessments after screening.)||months||95% Confidence Interval|Median
169324|NCT00138645|Primary|Percent Change in Body Weight (Completers).|Percent change in body weight from baseline to week 24(completers).|24 weeks|||change in percent:baseline body weight||Standard Error|Least Squares Mean
169325|NCT00138645|Secondary|Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6||April 2005 to May 2006||||||
169326|NCT00138645|Secondary|Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6||April 2005 to May 2006||||||
169327|NCT00138645|Secondary|Change in Body Composition at Months 3 and 6||April 2005 to May 2006||||||
169328|NCT00138645|Primary|Body Weight Loss (kg and Percent) at Months 3 and 6||April 2005 to May 2006||||||
169329|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline and Day 35|PK parameter change from baseline to day 35 for AUC4 and AUC12|Baseline through day 35|||hr*mg/L||Full Range|Median
169330|NCT00138424|Secondary|The Pharmacodynamics of Cidofovir Will be Assessed by Correlating the Percent Change in BK Virus DNA in Urine and Plasma With Pharmacokinetic Changes Between Baseline Through Day 35|PK parameter change from baseline to day 35 for Cmax.|Baseline through day 35|||ng/mL||Full Range|Median
169331|NCT00138424|Primary|Number of Subjects Experiencing at Least One Laboratory Abnormality|The following lab values assessed during the 49 days of subject involvement were the following: hemoglobin, hematocrit, platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), serum creatinine, calcium, phosphorous, serum albumin, glucose, uric acid, magnesium, total protein, total bilirubin, alanine aminotransferase (ALT), asparate aminotransferase (AST) and alkaline phosphate. The outcome measure is the number of subjects experiencing at least 1 grade 1 (mild) or higher event.|Baseline through day 49|||Participants|||Number
169332|NCT00138424|Primary|Changes Observed in the Physical Examination: Heart Rate (Per Minute)|The heart rate is the number of heart beats per minute. The outcome measure is the change from baseline heart rate to day 49 heart rate.|Baseline through day 49.|Subject's whose heart rate was measured at baseline and day 49 visit||Change in Beats per Minute||Full Range|Median
169333|NCT00138424|Primary|Changes Observed in the Physical Examination: Body Temperature (Fahrenheit)|The temperature is a measure of body temperature in fahrenheit (F). The measure is a change between baseline temperature and day 49 temperature.|Baseline through day 49.|Subject's last visit minus baseline visit||Temperature (F)||Full Range|Median
169334|NCT00138424|Secondary|Allograft Rejection.|Allograft rejection is the number of subjects that rejected their kidney by the end of the study.|Day 49.|Number of rejections||Participants|||Number
169335|NCT00138424|Secondary|Allograft Function at the Completion of the Study|"Glomerular filtration rate (GFR) is a test used to check how well the kidneys are working. Specifically, it estimates how much blood passes through the tiny filters in the kidneys, called glomeruli, each minute. The normal health GFR is about 90 - 120 mL/min/1.73 m2. Older people will have lower normal GFR levels, because GFR decreases with age.~Abnormal Results are expected to be below 60 mL/min/1.73 m2 for 3 or more months are a sign of chronic kidney disease. A GFR result below 15 mL/min/1.73 m2 may be a sign of kidney failure."|Day 49.|subjects that had GFR at each visit last visit||mL/min/1.73 m2||Full Range|Median
169336|NCT00138424|Primary|Changes Observed in the Physical Examination: Blood Pressure (mm/hg)|"Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. Blood pressure usually refers to the arterial pressure of the systemic circulation. During each heartbeat, blood pressure varies between a maximum (systolic) and a minimum (diastolic) pressure. The measure is the difference between the baseline systolic and baseline diastolic value with the day 49 systolic and day 49 diastolic value."|Baseline through day 49.|||mm Hg||Full Range|Median
169337|NCT00138424|Primary|Changes Observed in the Physical Examination : Respiratory Rate (Per Minute)|Respiratory rate is the number of breaths per minute.|Baseline through day 49.|subjects whose respiratory rate was measured at baseline visit and at day 49 visit.||Change in Breaths per Minute||Full Range|Median
169338|NCT00138424|Primary|Number of Related Adverse Events|"The investigator’s assessment of an AE's relationship to study drug is part of the documentation process. All adverse events had their relationship to study product assessed using the following terms: associated (related)or not associated (not related). To help assess, the following guidelines were used.~Associated – There was a known temporal relationship and/or, if re-challenge was done, the event abates with de-challenge and reappears with re-challenge and/or the event was known to occur in association study product or with a product in a similar class of study products~Not Associated -the AE was completely independent of study product administration; and/or evidence existed that the event was definitely related to another etiology."|Baseline through day 49.|Number of Related Events||Events|||Number
169339|NCT00138424|Primary|Number of Adverse Events by Grade of Event|"Adverse events are reported as grades:~Toxicity Grade I: a mild event (an event that requires minimal or no treatment and does not interfere with the subject's daily activities.~Toxicity Grade II: a moderate event (an event that results in a low level of inconvenience or concern with the therapeutic measures and may cause some interference with functioning.~Toxicity Grade III: a severe event (an event that interrupts a subject's usual daily activity and may require systemic drug therapy or other treatment and may be incapacitating.~Toxicity Grade IV: Life threatening (any adverse drug experience that places the patient or subject at immediate risk of death from the reaction as it occurred)"|Baseline through day 49.|||Events|||Number
169340|NCT00138424|Secondary|Number of Days to at Least 50% Reduction of Viral Load in Plasma and Urine||Baseline through day 49.|||Days||Full Range|Median
169341|NCT00138424|Secondary|Subjects Achieving 50% Reduction Viral Load in Plasma and Urine||Baseline through day 49.|||Participants|||Number
169348|NCT00138203|Primary|Response Per RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.|Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)|Only 14 subjects were evaulated for response. 2 of the total 16 subjects enrolled were not evaluable due to progression after only 1 cycle of treatment.||participants|||Number
169349|NCT00138151|Secondary|The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.|||||
169350|NCT00138151|Secondary|The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.||8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.|||||
169351|NCT00138151|Primary|Response Rate (Complete and Partial)|All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.|8 years|Study was closed prematurely due to slow accrual and lack of study drug. Insufficient accrual to evaluate response rate.|||||
169352|NCT00138125|Secondary|Clinical Benefit (CR + PR + SD > 6 Months)||5 years||||||
169353|NCT00138125|Secondary|Overall Survival||5 years||||||
169354|NCT00138125|Secondary|Duration of Response||5 years||||||
169355|NCT00138125|Secondary|Time to Tumor Progression||5 years||||||
169356|NCT00138125|Secondary|Overall Objective Response Rate||5 years||||||
169357|NCT00138125|Primary|Progression-free Survival|Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.|5 years|||participants|||Number
169358|NCT00138073|Secondary|Individual and Collective Frequency of Use and Usage Patterns of the Web-based Waveform Interpretation Guide|The study was terminated before the secondary outcome could be measured. Usage data was not collected over the following year.|1 year||||||
169359|NCT00138073|Primary|Score on a Computer-based Test on Pulmonary Artery Catheter Waveform Interpretation|The study was terminated before the primary outcome could be measured. None of the participants took the post-intervention test.|1 month||||||
169360|NCT00138034|Secondary|Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography|The occurence of any one of the above mentioned outcome measures. Only the first event per patient is counted.|6 months|||participants|||Number
169361|NCT00138034|Primary|6-month Reocclusion|Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography|6 months|||participants|||Number
169362|NCT00137969|Secondary|Number of Participants Who Achieved an MCR in The ITT Population|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From Weeks 24 to 52|ITT population||participants|||Number
169363|NCT00137969|Secondary|Change in SLE Expanded Health Survey Physical Function Score From Baseline|Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved.|From baseline to 52 weeks|ITT population||score on a scale||Standard Deviation|Mean
169364|NCT00137969|Secondary|Time to First Moderate or Severe Flare|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state.|52 weeks|Number of participants who ever reached C/D/E for all 8 BILAG domains before Day 364 visit. If a participant reached C/D/E at the last visit, then this participant was excluded from the analysis.||days||95% Confidence Interval|Median
169365|NCT00137969|Secondary|Number of Participants Who Achieved a BILAG C or Better in All Domains|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains.|24 weeks|ITT population||participants|||Number
169366|NCT00137969|Secondary|Number of Participants Who Achieved a PCR (Including MCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24.|From baseline to 52 Weeks|ITT population||participants|||Number
169381|NCT00137449|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
169367|NCT00137969|Secondary|Number of Participants Who Achieved an MCR (Excluding PCR)|The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|ITT population||participants|||Number
169368|NCT00137969|Secondary|Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period|"The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as:~Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks.~Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study.~Minus the Time-Adjusted AUC by the baseline BILAG global score"|From baseline to 52 weeks|ITT population||BILAG score unit||Standard Deviation|Mean
169369|NCT00137969|Primary|Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period|The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6.|From baseline to 52 weeks|Intent-to-treat (ITT) population||Participants|||Number
169370|NCT00137631|Primary|Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months|||number of episodes||Standard Deviation|Mean
169371|NCT00137631|Primary|Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners||6 months|||number of episodes||Standard Deviation|Mean
169372|NCT00137631|Primary|Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior||6 months|||participants|||Number
169373|NCT00137631|Primary|Number of Participants Reporting HIV Testing Behavior||6 months|||participants|||Number
169374|NCT00137631|Primary|Any Unprotected Anal Intercourse (UAI) With Casual Partners|Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)|6 months|||Number of episodes||Standard Deviation|Mean
169375|NCT00137449|Secondary|Score of EQ-5D (Euro Quality of Life-5 Dimension) Weighted Health Index|EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where 0.0 = death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline (includes data available for >=10 subjects).|Baseline, Day 1 & 15 of each treatment cycle up to 1 year on study|ITT population||score on scale||Full Range|Median
169376|NCT00137449|Secondary|Score of EQ-VAS (Euro Quality of Life -Visual Analog Scale)|EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (Increase or Decrease from baseline) included data available for >=10 subjects.|Baseline, Day 1 &15 of each treatment cycle up to 1 year on study|ITT population.||score on scale||Full Range|Median
169377|NCT00137449|Secondary|Score of FACIT-Fatigue Scale|FACIT-Fatigue Scale: Overall score from 13-question questionnaire (measures fatigue/asthenia for patients with chronic, life-threatening illnesses). For each question, patient rates condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Maximum, minimum mean included data available for >=10 subjects.|Baseline, Day 1 & 15 of each treatment cycle|ITT population||score on scale||Standard Deviation|Mean
169378|NCT00137449|Secondary|Overall Survival (OS) and One-year Survival [Descriptive Statistics]|Overall survival is defined as time from the date of first dose of study medication to the date of death due to any cause. One year survival rate defined as the probability that a patient is alive 1 year after the date of first study medication.|Survival status was collected by telephone contact every 2 months for up to 2 years from study entry.|ITT population (all subjects enrolled that received at least 1 dose of study medication).||participants|||Number
169379|NCT00137449|Secondary|Duration of Tumor Response (DR) [Descriptive Statistics]|DR was defined as the time from the date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the date of the first documentation of objective tumor progression or to death due to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. Number of responders (AM=3, PM=5, Total=8)||weeks||Full Range|Median
169380|NCT00137449|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of first documentation of objective tumor progression that occurred on treatment including within 28 days after the last dose of study medication.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
169382|NCT00137449|Secondary|Duration of Stable Disease|Duration of SD is the time from the date of first documentation of stable disease to the date of first documentation of objective tumor progression or death due to any cause that occurred within 28 days after last dose of study medication, whichever occurred first.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||Participants|||Number
169383|NCT00137449|Secondary|Number of Participants With Overall Confirmed Objective Disease Response (ORR)|Overall confirmed objective disease response is defined as a confirmed CR, or confirmed PR according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
169384|NCT00137449|Secondary|Number of Participants by Best Confirmed Response Category According to RECIST|Best confirmed response (BCR) defined as best response [confirmed CR, confirmed PR, SD, PD(progressive disease), not evaluable (NE)] recorded from start of treatment until disease progression / recurrence. Best response of SD must have met SD criteria at least once after first dose at minimum interval of 6 weeks.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type.||participants|||Number
169385|NCT00137449|Primary|Number of Participants With Clinical Benefit Response (CBR) According to RECIST|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.|Planned duration on this protocol of up to 1 year|ITT population (all subjects enrolled that received at least 1 dose of study medication) with measurable disease at baseline and correct histological cancer type. CR+PR+(SD for >=24 weeks)||participants|||Number
169386|NCT00137436|Secondary|Preliminary Assessment of PSA Modulation by SU011248|PSA modulation analyzed by the mean change in PSA response measured as ng/mL.|Baseline to Day 28|ITT population; PSA modulation was listed as a secondary endpoint for Phase 2, however, modulation was planned for analysis only for Phase 1 portion of the study. No formal analysis was completed to determine modulation.||ng/mL||95% Confidence Interval|Mean
169387|NCT00137436|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)|Assesses health related quality of life and advanced prostate cancer specific symptoms. FACT-General (FACT-G) assesses 4 domains: physical, social and family, emotional, and functional well-being. The prostate cancer subscale assesses prostate cancer symptoms focusing on pain, urination problems, and sexual functions. Individual scores range from 0 (not at all) to 4 (very much). Scores for some of the individual questions are reverse-coded in order for higher scores to correspond to better health status. FACT-P overall score range is 0 to 156; higher scores indicate better health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.||scores on a scale||95% Confidence Interval|Mean
169388|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain interference index score (to measure how much pain had interfered with daily activities) was derived from Questions 7A-7G with a range from 0 (no interference) to 10 (completely interferes); higher scores indicate more interference.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|PRO evaluable population; (n)=number of participants with evaluable data at observation.||scores on a scale||95% Confidence Interval|Mean
169389|NCT00137436|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)|The questionnaire assesses pain intensity (worst, least, average, and right now), level of relief in the last 24 hours, and the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). The pain intensity index score was derived from Questions 2-5 with range from 0 to 10 (0: no pain; 1-4: mild pain; 5-6: moderate pain; 7-10: severe pain); higher scores indicate worse health status.|Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study)|Patient reported outcomes (PRO) evaluable population defined as participants in the ITT population who received at least 1 dose of study medication (sunitinib or docetaxel) and had baseline data; (n)=number of participants with evaluable data at observation.||scores on a scale||95% Confidence Interval|Mean
169390|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3|Soluble protein biomarker VEGFR3 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT||pg/mL||Full Range|Median
169391|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2|Soluble protein biomarker VEGFR2 measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT||pg/mL||Full Range|Median
169392|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC|Soluble protein biomarker VEGFC measured as pg/mL. CBR defined as confirmed CR (disappearance of all target lesions) or confirmed PR (≥30% decrease in sum of longest dimensions [LD] of target lesions taking as reference the baseline sum LD) or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) ≥3 months versus PD (≥20% increase in sum LD of target lesions taking as reference the smallest sum LD recorded since treatment started, unequivocal progression of existing non-target lesions, or appearance of ≥1 new lesions) or SD <3 months.|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14|ITT||pg/mL||Full Range|Median
169393|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3|Soluble protein biomarker Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT||pg/mL||Full Range|Median
169394|NCT00137436|Secondary|Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2|Soluble protein biomarker Vascular Endothelial Growth Factor receptor 2 (VEGFR2) measured as pg/mL. PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT||pg/mL||Full Range|Median
169395|NCT00137436|Secondary|Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC|Soluble protein biomarker Vascular Endothelial Growth Factor C (VEGFC) measured as picograms per milliliter (pg/mL). PSA responders are participants with a confirmed PSA response as per the Working Group criteria (>50% decrease from baseline) and non-responders are those not meeting the definition of responder. Ratio=value of soluble protein biomarkers at each time point to the value at baseline (C1D14 : C1D1).|Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14|ITT||pg/mL||Full Range|Median
169396|NCT00137436|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Defined as confirmed complete response (CR: disappearance of all target lesions) or confirmed partial response (PR: ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; N=participants with measurable disease at baseline, received at least 1 dose of study medication, and had correct histological cancer type.||percentage of participants||95% Confidence Interval|Number
169397|NCT00137436|Secondary|Duration of PSA Response (DPR)|Defined as time from first documentation of PSA response (≥50% decrease in PSA from baseline that is subsequently confirmed) to first documentation of PSA progression (defined for patients with a PSA response as a 50% increase over nadir [lowest] and increase in absolute-value PSA level by at least 5 ng/mL [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir / lowest] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value). Calculated as (end date for DPR – first PSA response + 1)/7.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT; DPR only calculated for the subgroup of patients with PSA response rate.||weeks||Full Range|Median
169398|NCT00137436|Secondary|Time to PSA Progression|Defined as the time from start of study treatment to first documentation of PSA progression using the PSA Working Group criteria calculated as (first event date – first dose date + 1)/7. PSA progression is defined for patients with a PSA response, as a 50% increase over nadir (lowest) and increase in absolute-value PSA level by at least 5 nanograms per milliliter (ng/mL) [or back to baseline] and for patients without a PSA response as a 25% increase over baseline [or nadir (lowest)] and increase in absolute-value PSA level by at least 5 ng/mL, both confirmed by a second value.|Baseline to first documentation of PSA progression up to 28 days after date of last dose|ITT||weeks||Full Range|Median
169399|NCT00137436|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.|Baseline, Day 1 of each 21-day cycle|The intent-to-treat (ITT) population was defined as all patients enrolled in the study that receive at least 1 dose of study medication (SU011248 or docetaxel)||percentage of participants||95% Confidence Interval|Median
169400|NCT00137423|Secondary|Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score|EQ-VAS score on the self-rated “thermometer” indicated the patient’s own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT||score on scale||Full Range|Median
169401|NCT00137423|Secondary|Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index|EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT||score on scale||Full Range|Median
169411|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization|The number of participants with one or more weight service appointments in the one year during implementation (implementation sites versus control sites) for those participants who were overweight at the baseline interview (e.g., eligible for weight services). This only includes participants who were overweight at the baseline interview (e.g., eligible for weight services).|1 year|||participants|||Number
169412|NCT00137267|Secondary|Number of Days Engaged|Number of days veteran was involved with the program, from initial consent to last day of contact|8 weeks|||Days engaged in program||Standard Deviation|Mean
169402|NCT00137423|Secondary|Summary of FACIT Fatigue Scale Overall Score|FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.|Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.|ITT; Results summarized by cohort & time point through Cycle 13 (the last cycle for which more than 3 subjects completed the questionnaire on either arm). If more than 50% of the items in the scale were answered, then missing items were imputed with the mean of the non-missing items scored at that visit. Outcome based on completed questionnaires.||score on scale||Standard Deviation|Mean
169403|NCT00137423|Secondary|Overall Survival|Overall survival is time from the date of first dose of medication to the date of death due to any cause|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Patients who are alive at the time of analysis or who are lost to follow up are censored on the last date they were known to be alive. Estimates are based on the Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley method. n=54,53(AM,PM).||weeks||95% Confidence Interval|Median
169404|NCT00137423|Secondary|Progression Free Survival (PFS)|Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; Calculation based on subgroup of patients with baseline disease assessment, measurable disease at baseline, correct histological type and are refractory to cytokine. Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. N=53,52(AM,PM).||weeks||95% Confidence Interval|Median
169405|NCT00137423|Secondary|Time to Tumor Progression (TTP)|Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT;TTP calculated based on subgroup with baseline disease assessment, measurable disease at baseline, correct histological type and refractory to cytokine.Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. n=53,52(AM,PM).||weeks||95% Confidence Interval|Median
169406|NCT00137423|Secondary|Duration of Tumor Response|Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; DR time from start of 1st documentation of objective tumor response to 1st documentation of objective tumor progression or death & calculated for the subgroup of subjects with a confirmed objective tumor response. Descriptive statistics for responders who had an event. Total number responders n= 15,6(AM,PM). Response duration n=7,3(AM,PM).||weeks||Full Range|Median
169407|NCT00137423|Primary|Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects|Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were > 4 weeks apart. CR=disappearance of all target lesions. PR is a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up|ITT; CR,PR calculated from patients with measurable disease at baseline+correct histological cancer type+ refractory to prior cytokine-based therapy n= 53,52 (AM,PM)||participants|||Number
169408|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes|Chi-square analysis was used to examine competitive employment gained during treatment in implementation versus control groups. The dependent variable was competitive employment. Individuals included were only those who expressed interest in returning to work at both the baseline and follow-up interview time-points.|1 year|||competitive employment|||Number
169409|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization|The number of participants with one or more Supported Employment appointments in the one year during implementation (implementation sites versus control sites) for those participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services). This only includes participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services).|1 year|||participants|||Number
169410|NCT00137280|Primary|The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes|Analysis of Covariance (ANCOVA) was used to examine weight gained during treatment in implementation versus control groups. The dependent variable was final weight. Baseline weight, weight 6 months prior to baseline, and baseline psychotic and negative symptom subscales were included as covariates. The inclusion of weight 6 months prior to baseline served to control for subjects’ weight gain/loss trajectories prior to entering the study. The two-way interactions of group by covariates were also included in the model.|1 year|||pounds||Standard Error|Least Squares Mean
169413|NCT00137267|Primary|Treatment Engagement|Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period|8 weeks|||number of treatment sessions attended||Standard Deviation|Mean
169414|NCT00137111|Other Pre-specified|Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and NLRP3 expression in RNA by MTT assay||arbitrary units||Inter-Quartile Range|Median
169415|NCT00137111|Other Pre-specified|Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells|Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.|Pre-treatment|One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.||arbitrary units||Inter-Quartile Range|Median
169416|NCT00137111|Secondary|Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)|"White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count~Measurement: Percentage change of leukemia cells from baseline"|Immediately before the methotrexate infusion and three days after subsequent infusion|Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate’s antileukemic effects.||Percent change||Standard Deviation|Mean
169417|NCT00137111|Secondary|Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).|Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.|42 hours after start of high dose methotrexate infusion (HDMTX)|The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .||pmol/1,000,000,000 cells||Standard Deviation|Mean
169418|NCT00137111|Secondary|Minimal Residual Disease (MRD)|Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%).|End of Induction (Day 46 MRD measurement)|Patients who completed induction and had successful MRD studies on day 46.||participants|||Number
169419|NCT00137111|Primary|Continuous Complete Remission Since Week 56 Therapy.|CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.|Median follow up time (range) 4.5 (1 to 7.8) years|Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.||Percentage of participants|||Number
169420|NCT00137111|Primary|Overall Event-free Survival (EFS)|EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.|Median follow-up time (range) 5.6 (1.3 to 8.9) years|498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.||Percentage of Participants|||Number
169421|NCT00137046|Secondary|Insulin Antibodies|Median insulin antibodies at each visit measured in micro units per milliliter (microU/mL).|Baseline through Extension Month 39|FAS; (n)= number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.||microU/mL||Full Range|Median
169422|NCT00137046|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of hemoglobin per year (ml/min/mmHg/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the annual rate of change in DLco were not summarized as planned.||ml/min/mmHg/yr||Standard Deviation|Mean
169423|NCT00137046|Primary|Annual Rate of Change in Forced Expiratory Volume in 1 Second (FEV1)|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through Extension Follow-up Month 6 or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Annual Rate of Change in FEV1 were not summarized as planned.||liters per year||Standard Deviation|Mean
169424|NCT00137046|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and TLC results were not summarized as planned.||liters||Standard Deviation|Mean
169425|NCT00137046|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through Extension Follow-up Month 6 or End of Study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and FVC results were not summarized as planned.||liters||Standard Deviation|Mean
169426|NCT00137046|Primary|Summary of ≥ 20% Decliners in Carbon Monoxide Diffusing Capacity (DLco).|Number of subjects with a post-baseline Carbon Monoxide Diffusing Capacity (DLco) decrease of ≥ 20% [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat DLco was performed.|Month 3 through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
169462|NCT00136916|Secondary|Change From Baseline in Body Weight|Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||kg||Standard Deviation|Mean
169427|NCT00137046|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from Baseline: mean of (value of Carbon Monoxide Diffusing Capacity [DLco] measured in milliters/minutes/millimeters of mercury [mL/min/mmHg] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Due to study termination, originally planned inferential analysis change from Month 3 to extension Month 60 was not done.||mL/min/mmHg||Standard Deviation|Mean
169428|NCT00137046|Secondary|Cough Questionnaire|Subject completed cough questionnaire with reference to the past 4 weeks. Six question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (subcutaneous [SC] or inhaled), and productivity of cough; range 0 (no symptoms) to 4 (severe symptoms). Questionnaire was administered at Week 0 and then at subsequent visits only if cough was identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through Extension Follow up Month 3|FAS. Due to early termination of the study a limited set of analyses were undertaken and results of the Cough Questionnaire were not summarized as planned.||scores on scale||Standard Deviation|Mean
169429|NCT00137046|Secondary|Lipids|Total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|Full Analysis Set (FAS): received at least 1 dose of study treatment. Due to early termination of the study a limited set of analyses were undertaken and lipid results were not summarized as planned.||mg/dL||Standard Deviation|Mean
169430|NCT00137046|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through ,Extension Follow-up Month 6 and every 6 months thereafter or end of study|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Transition Dyspnea Index were not summarized as planned.||scores on scale||Standard Deviation|Mean
169431|NCT00137046|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment.|Week - 1|FAS FEV1. Due to early termination of the study a limited set of analyses were undertaken and results of the Baseline Dyspnea Index were not summarized as planned.||scores on scale||Standard Deviation|Mean
169432|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose Adjusted for Body Weight|Total Daily Short-Acting Insulin Dose adjusted for body weight (milligrams [mg] or units divided by kilograms [kg]). Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/kg, units/kg||Standard Deviation|Mean
169433|NCT00137046|Secondary|Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (mg) for the Inhaled Insulin group was Inhaled Insulin. Short-acting insulin (unit) for the Subcutaneous Insulin group included Insulin Lispro, Insulin Aspart, and Regular Insulin.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg, units||Standard Deviation|Mean
169434|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose Adjusted for Body Weight|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units/kg||Standard Deviation|Mean
169435|NCT00137046|Secondary|Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)|Total Daily Long-Acting Insulin Dose Unadjusted for Body Weight; long-acting insulin included NPH Insulin, Ultralente, and Insulin Glargine for both groups.|Month 3 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units||Standard Deviation|Mean
169436|NCT00137046|Secondary|Change From Baseline Body Weight|Body weight: mean Baseline and change from Baseline in kilograms (kg). Change from baseline = mean body weight in kilograms (kg) at observation minus mean baseline body weight.|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||kilograms||Standard Deviation|Mean
169437|NCT00137046|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from Baseline: mean of (value of fasting plasma glucose [milligrams per deciliter (mg/dL)] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/dL||Standard Deviation|Mean
169438|NCT00137046|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event = all 3 of the following criteria were met: subject unable to treat self, exhbited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, loss of consciousness); and blood glucose measurement was ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, subcutaneous glucagon, or i.v. glucose. Subject months = elapsed number of months subject was in study in each time interval. Crude event rate = total events divided by subject months * 100.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||events / subject months * 100|||Number
169463|NCT00136916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/dL||Standard Deviation|Mean
169439|NCT00137046|Secondary|Hypoglycemic Event Rates|A Hypoglycemic event was identified by characteristic symptoms of hypoglycemia with no blood glucose check with prompt resolution with food intake, subcutaneous glucagon, or intravenouus glucose; characteristic symptoms with blood glucose of 59 milligrams per deciliter (mg/dL) (3.2 mmol/L) or less with blood glucose check; or any glucose measurement of 49 mg/dL (2.7 mmol/L) or less, with or without symptoms. Subject months = elapsed number of months a subject was in the study in each time interval. Crude event rate = total events divided by subject month of treatment.|Month 1 through Extension Month 39|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||total events/subject months|||Number
169440|NCT00137046|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from Baseline: mean of (value of Glycosylated Hemoglobin [HbA1c] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||percent||Standard Deviation|Mean
169441|NCT00137046|Primary|Summary of ≥ 15% Decliners in Forced Expiratory Volume in One Second (FEV1)|Number of subjects with a post-baseline Forced Expiratory Volume in One Second (FEV1) decrease of ≥ 15 % [(baseline observed value minus visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrent illness, a repeat FEV1 was performed.|Month 3 through Extension Follow-up 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
169442|NCT00137046|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Change from Baseline: mean of (value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value).|Baseline through Extension Follow-up Month 3|Full Analysis Set (FAS) FEV1: received at least 1 dose of study drug, had a Baseline FEV1, and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.||liters||Standard Deviation|Mean
169443|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (ITT Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.||days||95% Confidence Interval|Median
169444|NCT00136955|Primary|Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Intent-to-treat (ITT) population: All included subjects who received at least one drop of study medication will be included in the ITT population.||participant|||Number
169445|NCT00136955|Secondary|Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)|TTP is date of first infusion to first date of documented progression or date of death due to progressive disease or date of further anti-tumor therapy, whichever occurs first. OS is time from date of first infusion to date of death due to any cause or last date patient is known to be alive at date of data cutoff for final analysis.|Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks.|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.||days||95% Confidence Interval|Median
169446|NCT00136955|Primary|Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)|Tumor response according to RECIST.|At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment)|Evaluable population: 1) Patient received at least two complete cycles of treatment (8 weeks on study). If progression occurred before end of second cycle, patient considered evaluable (early progression); 2) all baseline lesions assessed at least once after second cycle with same method of measurement as baseline; 3) no major protocol violation.||participant|||Number
169447|NCT00136916|Secondary|Insulin Antibodies|Observed values for insulin antibodies measured as micro units per milliliter (microU/mL).|Baseline through extension Month 36|FAS; (n)=number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint.||microU/mL||Full Range|Median
169448|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits|"Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. No response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn)."|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.||participants|||Number
169449|NCT00136916|Secondary|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits|Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline.|Baseline, M12, M24, Ext M6, Ext M18, Ext M36|All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete.||participants|||Number
169450|NCT00136916|Secondary|Transition Dyspnea Index (TDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (–9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement.|Week 4 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TDI were not summarized as planned.||scores on scale|||Number
169451|NCT00136916|Secondary|Baseline Dyspnea Index (BDI)|Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0–12). Lower score indicates greater impairment.|Week -1|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of BDI were not summarized as planned.||scores on scale|||Number
169452|NCT00136916|Secondary|Cough Questionnaire|Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection.|Week 0 and if indicated through extension follow up Month 3|FAS. Due to early termination of study a limited set of analyses were undertaken and results of Cough Questionnaire were not summarized as planned.||scores on scale|||Number
169453|NCT00136916|Secondary|Severe Hypoglycemic Event Rates|Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval.|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||event rate (events/subject months*100)|||Number
169454|NCT00136916|Secondary|Hypoglycemic Event Rates|Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval).|Month 1 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||event rate (events/subject months)|||Number
169455|NCT00136916|Primary|Summary of ≥ 20 % Decliners in DLco|Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
169456|NCT00136916|Primary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco)|Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension M36 LOCF based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure Annual rate of change in Carbon Monoxide Diffusion Capacity (DLco).||ml/min/mmHg||Standard Deviation|Mean
169457|NCT00136916|Secondary|Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides|Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL).|Week -4 through Month 24|FAS: received at least 1 dose of study treatment. Due to early termination of study a limited set of analyses were undertaken and results of Lipids were not summarized as planned.||mg/dL||Standard Deviation|Mean
169458|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Adjusted for Body Weight)|Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg).|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg/kg, units/kg||Standard Deviation|Mean
169459|NCT00136916|Secondary|Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight)|Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||mg, units||Standard Deviation|Mean
169460|NCT00136916|Secondary|Total Daily Long-acting Insulin (Adjusted for Body Weight)|Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units/kg||Standard Deviation|Mean
169461|NCT00136916|Secondary|Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight)|Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine.|Month 3 through extension Month 36|FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||units||Standard Deviation|Mean
169464|NCT00136916|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||percent||Standard Deviation|Mean
169465|NCT00136916|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity measured in liters (L).|Baseline through extension follow up Month 3|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TLC were not summarized as planned.||L||Standard Deviation|Mean
169466|NCT00136916|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) measured in liters (L).|Week -3 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of FVC were not summarized as planned.||L||Standard Deviation|Mean
169467|NCT00136916|Primary|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco)|Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in DLco were not summarized as planned. Cross reference outcome measure: change from baseline in Carbon Monoxide Diffusion Capacity (DLco).||ml/min/mmHg/yr||Standard Deviation|Mean
169468|NCT00136916|Primary|Summary of ≥ 15 % Decliners in FEV1|Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed.|Month 3 through extension follow up Month 3|FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively.||participants|||Number
169469|NCT00136916|Primary|Annual Rate of Change in FEV1|Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr).|Week -2 through extension follow up Month 3 or end of study|FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned.||L/yr||Standard Deviation|Mean
169470|NCT00136916|Primary|Change From Baseline in FEV1|Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value).|Baseline through extension follow up Month 3|FAS FEV1; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second.||L||Standard Deviation|Mean
169471|NCT00136916|Primary|Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1)|Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value).|Month 3 through extension Month 60|Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1.||L||Standard Deviation|Mean
169472|NCT00136838|Other Pre-specified|Craving|Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).|immediately following cue expose|||units on a scale (0-70)||Standard Error|Mean
169473|NCT00136838|Primary|Cigarette Choice After 3 Day Abstinence|Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices|During Day 4 experimental session|||number of cigarette choices (0-6)||Standard Error|Mean
169474|NCT00136812|Primary|7 Day Point Prevalence of Cigarette Abstinence||3 mo, 6 mo, 12 mo, and 18 mo post-baseline|||% quit||95% Confidence Interval|Number
169475|NCT00136760|Secondary|Cigarettes Smoked Per Day||3 weeks|||cigarettes per day||Standard Deviation|Mean
169476|NCT00136760|Primary|Urinary Cotinine|Urinary Cotinine levels at Week 4 (average of last 3 study visits)|3 weeks|||ng/ml||Standard Deviation|Mean
169477|NCT00136695|Primary|Lean Body Mass||1 year|||grams||Standard Deviation|Mean
169478|NCT00136357|Primary|Harvard Trauma Questionnaire|The Harvard Trauma Questionnaire measures PTSD Symptoms. This scale has 16 items and is rated on a Likert scale from 1-4. The total score is sum of the scores divided by the number of items. Higher scores indicated higher levels of PTSD symptoms.|Baseline, 12 weeks, 3 months|||units on a scale||Standard Deviation|Mean
169479|NCT00136318|Secondary|Safety||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment||||||
169480|NCT00136318|Secondary|Tolerability||assessed 2,4,12,24 and for genotype 1 and 4, 48 weeks of antiviral treatment||||||
169481|NCT00136318|Secondary|Sustained Virologic Response|(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment)|assessed 24 weeks after end of antiviral treatment|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.||percentage of participants||95% Confidence Interval|Number
169482|NCT00136318|Secondary|Health Related Quality of Life (HRQOL) Measured by the Short Form 36 (SF-36)||assessed 2,4,12,24 and 48 weeks of antiviral treatment||||||
169483|NCT00136318|Secondary|Severe Depression Defined as a MADRS Score of 25 or Higher||severe depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.||percentage of participants||95% Confidence Interval|Number
169484|NCT00136318|Secondary|Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria||major depression during 24 or 48 weeks of antiviral therapy|The final analysis included only patients who received at least 1 dose of escitalopram or placebo. Between-group differences for the secondary outcome parameters were calculated with a chi-square test.||percentage of participants||95% Confidence Interval|Number
169497|NCT00135798|Primary|Patients Who Are Negative for Hepatitis C Virus (HCV) RNA at 3 Months Post-transplant: Intent-to-Treat Analysis (ITT)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation.|3 months post-transplant|Intent-to-Treat (ITT) analyses of Transplanted patients assigned to treatment. Outcome is pTVR (post-transplant viral response)||participants|||Number
169485|NCT00136318|Secondary|Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)|Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression|Patients free of depression during 24 or 48 weeks of antiviral therapy|Number of patients per group who did not develop any depressive episode during 48 weeks of antiviral therapy.||participants|||Number
169486|NCT00136318|Primary|Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher|"Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as percentage of participants with MADRS scores > 13 (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)"|50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3|The final analysis included only patients who received at least one of escitalopram or placebo. Between group differences for the primary outcome parameters were calculated with a chi-square test. For the primary end point (MADRS score of 13 or higher), we treated missing MADRS assessments by multiple imputation.||percentage of participants||95% Confidence Interval|Number
169487|NCT00136084|Secondary|Relationship of Inhibition of DNA Synthesis and Clinical Response|Clinical response is defined as MRD (minimal residual disease) measured by flow cytometry at day 22. The MRD at day 22 is classified as positive (with MRD) or negative (no detectable MRD). The relation between inhibition of DNA synthesis and MRD was performed by logistic regression. In the model, logit of probability of MRD positive was regressed on inhibition of DNA synthesis.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. 17 of the 21 patients had evaluable day 22 MRD.||Percent inhibition of DNA Synthesis||Standard Error|Mean
169488|NCT00136084|Secondary|To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy|Inhibition of DNA synthesis is defined as the percentage of DNA synthesis rate at 24-hour post-araC treatment over DNA synthesis rate pre-araC treatment.|Measurements were assessed in Induction I chemotherapy|Of 232 eligible patients, 49 had DNA synthesis rate performed prior to araC treatment. Of the 49 patients, 23 had no 24-hr samples and 3 did not have enough cells in 24-hr samples. 21 patients with both pre and post araC samples were included in the DNA inhibition study. Of the 21 patients, 9 were treated on HDAC and 12 were treated on LDAC.||Percent Inhibition of DNA Synthesis||Standard Error|Mean
169489|NCT00136084|Secondary|To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy|Overall event-free survival (EFS) was defined as the time from study enrollment to induction failure, relapse, secondary malignancy, death, or study withdrawal for any reason, with event-free patients censored on the date of the last follow-up|Five Year|238 patients were enrolled on the study. Out of 238, 6 were determined to be ineligible and 2 were not randomized. Of the 230 patients, 14 bi-phenotypic leukemia patients were excluded. 216 AML patients were included to estimate EFS.||Percentage of Participants|||Number
169490|NCT00136084|Secondary|Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.|To estimate proportion of patients experiencing CTC Grade 3 or 4 toxicity during Induction II (Cytarabine + Daunomycin + Etoposide (ADE) + GO), who had no response to first course of induction therapy|Induction II|30 patients received ADE + GO during induction II and were analyzed. Out of the 30 patients, 11 patients were treated on HDAC arm, and 19 patients were treated on LDAC arm.||Participants|||Number
169491|NCT00136084|Secondary|Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO|To estimate proportion of patients with MRD reduction after one course of Induction II (cytarabine + daunomycin + etoposide (ADE) + GO), who had no response to first course of induction therapy.|Induction II|Out of the 30 patients received ADE + GO treatment, one patient had inevaluable MRD prior to and after the treatment. 29 patients were analyzed. Out of the 29 patients, 10 patients were treated on HDAC arm and 19 patients were treated on LDAC arm.||Participants|||Number
169492|NCT00136084|Secondary|Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)|To estimate the proportion of minimal residual disease (MRD)+ patients who become MRD- after one course of gemtuzumab ozogamicin (GO)|Consolidation I|Sixteen patients received GO treatment during consolidation I. One patient with negative MRD received GO treatment, which was not consistent with the protocol definition. 15 patients were analyzed. Out of the 15 patients, 7 patients were treated on HDAC arm and 8 patients were treated on LDAC arm.||Participants|||Number
169493|NCT00136084|Primary|Minimal Residual Disease (MRD).|Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (>=0.1%).|Day 22 MRD measurement|Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.||participants|||Number
169494|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Per-Protocol Analysis (PP)|Per-Protocol (PP) analyses of all patients. Combined Virologic Response (CVR)includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR), analysed among patients who received treatment.|Pre-transplant and 3 months post-transplant|All study patients||participants|||Number
169495|NCT00135798|Primary|Patients Who Are Negative for HCV RNA at 3 Months Post-transplant: Per-Protocol Analysis (PP)|Post-transplant virologic response (pTVR) defined as undetectable HCV RNA at week 12 after liver transplantation, analysed among patients who received treatment.|3 months post-transplant|Per-Protocol (PP) analyses of Transplanted patients who received treatment. Outcome is pTVR (post-transplant viral response)||participants|||Number
169496|NCT00135798|Secondary|Patients With Combined Virologic Response (CVR): Intent-to-Treat Analyses (ITT)|Intent-to-Treat (ITT) analyses of all patients. Combined Virologic Response (CVR), which includes both sustained virologic response pre-transplant (SVR) and post-transplant virologic response (pTVR)|Pre-transplant and 3 months post-transplant|All study patients||participants|||Number
169535|NCT00135330|Secondary|Change in Fasting HDL Cholesterol|Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
169498|NCT00135694|Secondary|Total Burden of Immunosuppression From Random Assignment to Month 24|Total immunosuppression score in units taken as the sum of units per day over the 2-year period from randomization to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.).|Randomization to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.||units||Full Range|Mean
169499|NCT00135694|Secondary|Total Immunosuppression From Month 21 to Month 24 Post-randomization|Daily immunosuppression score in units per day averaged over the 3-month period from Month 21 to Month 24 post-randomization. Daily doses were assigned a score of 1 unit as follows: tacrolimus 1 mg, cyclosporine 100 mg, Sirolimus 1 mg, mycophenolate mofetil 1000 mg, Mycophenolic acid 720 mg, azathioprine 50 mg, and prednisone 5 mg. Any antibody use equaled 20 units. Unit scores based on Vasudev (Vasudev B, Hariharan S, Hussain SA, Zhu YR, Bresnahan BA et al. BK virus nephritis: risk factors, timing, and outcome in renal transplant recipients. Kidney Int. 2005; 8(4):1834-1839.)|Month 21 to Month 24 post-randomization|Randomized participants still being followed 24 months post-randomization.||units per day||Full Range|Mean
169500|NCT00135694|Secondary|Number of Participants Experiencing Graft Loss or Death|Number of participants with graft loss or death. Graft loss is defined as subject death or re-transplantation.|Randomization to 2 years post-randomization.|Randomized participants (intent-to-treat sample)||participants|||Number
169501|NCT00135694|Secondary|Number of Hepatitis C Infected Participants With Progression of Hepatitis C Related Liver Disease, Defined as Stage 4 or Higher Fibrosis on the Ishak Scale|Number of subjects with a biopsy showing stage 4 fibrosis or higher on the Ishak scale. Stage 4 represents at least 13.7% fibrosis measurement with a description of fibrous expansion of portal areas with marked bridging (P-P) as well as portal to central (P-C). Stage 5 is marked bridging (P-P and/or P-C), with occasional nodules (incomplete cirrhosis) and stage 6 is cirrhosis, probable or definite.|Randomization to 2 years post-randomization.|Hepatitis C infected participants randomized.||participants|||Number
169502|NCT00135694|Secondary|Immunosuppression-free Duration|Time (in days) from withdrawing off of all immunosuppressive drugs to re-starting immunosuppression or study termination/completion.|Discontinuation of all immunosuppression to end of trial participation or to time of restarting immunosuppression, whichever came first, assessed up to two years|Participants randomized to immunosuppression withdrawal who completed withdrawal and discontinued all immunosuppression||Days||Full Range|Mean
169503|NCT00135694|Secondary|Number of Participants Who Successfully Stop Taking Immunosuppression for at Least 6 Months||Randomization until study completion or participant termination (up to six years post-transplant)|Participants randomized to immunosuppression withdrawal||participants|||Number
169504|NCT00135694|Secondary|Number of Participants Who Qualify for Random Assignment||One to two years post-transplantation|All subjects transplanted||participants|||Number
169505|NCT00135694|Primary|Number of Participants With Clinical Complications Usually Attributed to Immunosuppression|This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events [CTCAE] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) using creatinine obtained prior to and closest to randomization will be considered the baseline and will be compared to the eGFR using creatinine obtained at 24 months +/- 3 months after randomization; b) for those with a baseline eGFR 30-90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR; c) for those with a baseline eGFR greater than 90 ml per min per 1.73 meter-squared, a 25% decrease in eGFR and a decrease in eGFR to less than 90 ml per min per 1.73 meter-squared.|Randomization to 2 years post-randomization|Evaluable randomized subjects having a targeted event and/or having available data for calculation of eGFR||participants|||Number
169506|NCT00135356|Secondary|Mean Change From Baseline in CD4 Count|Mean change from baseline in CD4 count among treated subjects|Baseline, Week 48, Week 96|Observed Cases (OC)||cells/mm3||Standard Error|Mean
169507|NCT00135356|Secondary|Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline|Virologic rebound was measured from the first dose of study therapy to the first of the 2 consecutive measurements ≥400 c/mL. Time to virologic rebound was analyzed using life tables. Measured Values show the Kaplan-Meier cumulative proportion of participants without virologic rebound up to the end of the respective interval.|Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96|Treated subjects with HIV RNA <400 c/mL at baseline.||Proportion of participants|||Number
169508|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation|Percentage of Participants with AEs leading to discontinuation of study therapy. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. All events listed in this table were SAEs, except for renal impairment and hypertriglycerideamia, which were an AEs (and did not meet the 5 percent threshold reported in Adverse Event module of this record).|Through Week 96|Treated subjects||Percent of Participants|||Number
169509|NCT00135356|Secondary|Percentage of Participants With Abnormal Liver Function Tests|Percentage of participants with Abnormal Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBILI) measurements. Values for liver tests are graded using the modified World Health Organization (WHO) criteria. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life threatening or disabling.|Week 48, Week 96|All treated participants||Percentage of Participants|||Number
169524|NCT00135330|Secondary|Pedal Edema Score|"Pedal edema scores experienced by each patient throughout the study (1+ indicates a patient experienced a pedal edema score of 1 , 2, or 3; 2+ indicates a patient experienced a pedal edema score of 2 or 3, etc.)~Scale:~Slight pitting, no visible distortion, disappears rapidly~A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 – 15 seconds~The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen~The pit is very deep, lasts as long as 2 – 5 minutes, and the dependent extremity is grossly distorted"|20 weeks|Full Analysis Set||participants|||Number
169510|NCT00135356|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Percentage of Participants with AEs, Serious AEs (SAEs), Deaths, and AEs leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Through Week 96 of study therapy|Treated participants||Percentage of Participants|||Number
169511|NCT00135356|Secondary|Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96|Mean changes from baseline in proportion of waist to hip measurements.|Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||ratio||Standard Error|Mean
169512|NCT00135356|Secondary|Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||kg/m2||Standard Error|Mean
169513|NCT00135356|Secondary|Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||cm||Standard Error|Mean
169514|NCT00135356|Secondary|Mean Changes From Baseline in Body Weight at Week 48 and Week 96||Baseline, Week 48, Week 96|LOCF; n=number of participants with baseline value and value at or before analysis timepoint||kg||Standard Error|Mean
169515|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is an index used in evaluation of obese patients at risk for type 2 diabetes which requires fasting glucose and insulin concentrations. It is a mathematical model based on the theory of a negative feedback loop between the liver and β-cells that regulates both fasting glucose and insulin concentrations and can be used to estimate pancreatic β-cell function and degree of insulin resistance. HOMA-IR normal values are between 2 and 2.5. HOMA-IR ≥ 2.5 indicates insulin-resistance.|Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.||mg/dL x uU/mL||Standard Error|Mean
169516|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.||microunits per milliliter||Standard Error|Mean
169517|NCT00135356|Secondary|Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96||Baseline, Week 48, Week 96|Treated participants (LOCF); n=number of participants with baseline value at or before analysis timepoint.||mg/dL||Standard Error|Mean
169518|NCT00135356|Secondary|Mean Percent Changes From Baseline in Fasting Lipids|Mean percent changes from baseline in fasting total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and non-HDL cholesterol, triglycerides, and apolipoprotein B|Baseline, Week 48, Week 96|Treated Subjects (LOCF). n=56 for LDL cholesterol in the PI/RTV arm at both timepoints||Percent change|||Number
169519|NCT00135356|Secondary|Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans|The mean percent change from baseline in total body fat by DEXA and in total adipose tissue (TAT) area by CT scans. Total body fat and TAT are both associated many factors (trunk fat + limb fat + other [weight, etc]), and thus clinical improvement cannot be predicted based solely an increase or decrease of these values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|TAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint||percent change||Inter-Quartile Range|Mean
169520|NCT00135356|Secondary|Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans|The mean percent change from baseline in physical signs of lipoatrophy, as assessed objectively by changes in peripheral adipose tissue (ie, limb fat (kg) by DEXA and in subcutaneous adipose tissue (SAT) area by CT scans. Clinical improvement is associated with stable values, or an increase in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|SAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before analysis timepoint.||percent change||Inter-Quartile Range|Mean
169521|NCT00135356|Secondary|Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.|The mean percent change from baseline in physical signs of lipohypertrophy, as assessed objectively by changes in visceral adipose tissue (VAT) area (cm2) by computed tomography (CT) scans and by changes in trunk fat (kg) by DEXA. Clinical improvement is associated with a decrease in values. (Baseline values can be found in the Baseline Characteristics section.)|Baseline, Week 48, Week 96|VAT analysis population=treated subjects with adipose tissue pairs (LOCF); trunk fat analysis population=treated subjects with fat pairs (LOCF); n=number of subjects with measurement at baseline and at or before the analysis timepoint.||Percent change||Inter-Quartile Range|Mean
169522|NCT00135356|Secondary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96|Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.(Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 96|Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.||ratio||Standard Error|Mean
169523|NCT00135356|Primary|Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48|Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)|Baseline, Week 48|Treated participants. Observed case (OC) analysis: n=participants with fat measurement at baseline and at the analysis timepoint. Last observation carried forward (LOCF): n=participants with fat measurement at baseline and at or before the analysis timepoint.||ratio||Standard Error|Mean
169536|NCT00135330|Secondary|Change in Fasting Total Cholesterol.|Change in fasting total cholestrol from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
169537|NCT00135330|Secondary|Change in Body Weight|Change in body weight from baseline to week 20.|Week 20|All patients who aave both baseline and at least one post baseline value in full analysis set.||kg||Standard Error|Least Squares Mean
169538|NCT00135330|Secondary|Change in Fasting Proinsulin|Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||pmol/L||Standard Error|Geometric Mean
169539|NCT00135330|Secondary|Change in Fasting Insulin|Change in fasting insulin from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||uIU/ml||Standard Error|Geometric Mean
169540|NCT00135330|Secondary|Change in Fasting C-peptide|Change in fasting C-peptide from baseline to week 20.|Week 20|Fasting C-peptide was initially identified as an outcome measure, but data for this measure were not subsequently collected at baseline or endpoint.|||||
169541|NCT00135330|Secondary|Change in Fasting Serum Glucose Concentration.|Change in fasting serum glucose concentration from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||mmol/L||Standard Error|Least Squares Mean
169542|NCT00135330|Secondary|Change in HbA1c|Change in HbA1c from baseline to week 20.|Week 20|All patients who have both baseline and at least one post baseline value in full analysis set.||Percentage||Standard Error|Least Squares Mean
169543|NCT00135330|Secondary|Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).|Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.|Week 20|All patients in full analysis set who have baseline and endpoint measurement.||mmol/L||Standard Error|Least Squares Mean
169544|NCT00135330|Secondary|Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).|Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||mmol/L||Standard Error|Least Squares Mean
169545|NCT00135330|Secondary|Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).|Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||mmol/L||Standard Error|Least Squares Mean
169546|NCT00135330|Secondary|Change in AUC for C-peptide During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||nmol-min/L||Standard Error|Geometric Mean
169547|NCT00135330|Secondary|Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).|Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||uIU-min/ml||Standard Error|Geometric Mean
169548|NCT00135330|Secondary|Change in Insulin iAUC From Baseline to Endpoint.|"Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint.||uIU-min/ml||Standard Error|Least Squares Mean
169549|NCT00135330|Secondary|Change in Insulin AUC in the First Stage From Baseline to Endpoint.|"Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. First stage represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test."|Week 20|All patients in full analysis set who participated in clamp tests and have both baseline and endpoint||uIU-min/ml||Standard Error|Least Squares Mean
169550|NCT00135330|Secondary|Change in Insulin Sensitivity Index as Measured by M-value.|Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.|Week 20|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurements.||mg/kg-min||Standard Error|Least Squares Mean
169551|NCT00135330|Secondary|Change in AUC for Glucose During a Meal Challenge Test (MCT).|Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.|Week 20|All patients in full analysis set who have both baseline and endpoint measurement.||mmol-min/L||Standard Error|Least Squares Mean
169552|NCT00135330|Primary|Change in ASIiAUC During a Hyperglycemic Clamp Test.|Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.|20 weeks|All patients in full analysis set who participated in clamp test and have both baseline and endpoint measurement.||uIU-min/ml||Standard Error|Least Squares Mean
169553|NCT00135200|Secondary|Incidence of Toxicities|Determination of the safety and tolerability of consolidation therapy with Bexxar, as determined by the incidence of toxicities|3 months||||||
169554|NCT00135200|Secondary|Time to Treatment Failure||3-6 months||||||
169555|NCT00135200|Secondary|Progression Free Survival Time||3-6 months||||||
169556|NCT00135200|Secondary|Duration of Response||3-6 months||||||
169557|NCT00135200|Secondary|Number of Participants With Complete Response (CR)|Determine the rate of conversion to complete response (CR)|6 months|||participants|||Number
169558|NCT00135200|Primary|Percentage of Patients With an Objective Response|"The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level.~An objective response may be:~Minimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations.~Partial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations.~Complete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation."|3 months|||percentage of patients||95% Confidence Interval|Number
169559|NCT00134901|Primary|Weekly Cocaine Use|Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.|weekly use during length of study participation|||days||Standard Deviation|Mean
169560|NCT00134901|Secondary|Cocaine Abstinence Based on Daily Self Reported Cocaine Use|A binary indicator of sustained abstinence, defined as three consecutive weeks of no cocaine use, obtained by self-report and verified using negative urine toxicology results, at any point of the trial;|reported weekly cocaine use for 12 weeks/ or study participation|All analyses were performed on an intent-to-treat basis||participants|||Number
169561|NCT00134784|Primary|Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images|The use of SPECT to measure striatal dopamine-transporter density with the use of [123I]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.|40 weeks|Per protocol||percent change of B-CIT Uptake|Participants|Standard Deviation|Mean
169562|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age|Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase.||Subjects|||Number
169563|NCT00134719|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.|From enrolment through the day preceding the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.||Subjects|||Number
169564|NCT00134719|Secondary|Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine|Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.|During a 43-day (Day 0-42) after the fourth dose|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.||Subjects|||Number
169565|NCT00134719|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period|Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.||Subjects|||Number
169566|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after the fourth dose vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase.||Subjects|||Number
169567|NCT00134719|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase|Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.|During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase|Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.||Subjects|||Number
169568|NCT00134719|Secondary|Anti-varicella Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
169569|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169570|NCT00134719|Secondary|Anti-mumps Titers in Initially Seronegative Subjects|Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
169802|NCT00130039|Secondary|Number of Patients With Ipsilateral Ischemic Stroke Rate|ischemic stroke event which occured in the vascular territory of initial symptomatic stenosis|upto 7 months after randomization|this outcome analysis was done ITT method||participants|||Number
169571|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169572|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|42 days after the fourth dose|Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169573|NCT00134719|Secondary|Anti-rubella Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
169574|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169575|NCT00134719|Secondary|Anti-measles Concentrations in Initially Seronegative Subjects|Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
169576|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects|The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.|42 days after the fourth dose|Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169577|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenY|Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169578|NCT00134719|Secondary|Number of Subjects With a Fourth Dose Response for hSBA-MenC|Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.|42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169579|NCT00134719|Secondary|Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5|The cut-off value assessed was a titer of 1:5.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point||Subjects|||Number
169580|NCT00134719|Secondary|Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL|The cut-off value assessed was 4 IU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169581|NCT00134719|Secondary|Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50|ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169582|NCT00134719|Secondary|Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL|The cut-off value assessed was 150 mIU/mL.|Just prior to the fourth dose and 42 days after the fourth dose|Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169610|NCT00134004|Secondary|Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation|Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.|1 year|||percentage of participants|||Number
169803|NCT00130039|Secondary|Number of Participants With Overall Cardiovascular Events|including nonfatal stroke, nonfatal myocardial infarction and vascular death.|upto 7 months after randomization|this outcome analysis was done intention to treat method||participants|||Number
169583|NCT00134719|Secondary|Anti-PRP Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
169584|NCT00134719|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169585|NCT00134719|Secondary|Anti-PSY Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
169586|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169587|NCT00134719|Secondary|Anti-PSC Concentrations|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
169588|NCT00134719|Secondary|Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169589|NCT00134719|Secondary|hSBA-MenY Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
169590|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169591|NCT00134719|Secondary|hSBA-MenC Titers|The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
169630|NCT00133809|Secondary|Number of Insulin-independent Subjects Following Islet Transplantation|Participants who did not need to take insulin at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months following islet transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation|||participants|||Number
169592|NCT00134719|Secondary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values|The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169593|NCT00134719|Secondary|rSBA-MenY Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Titer||95% Confidence Interval|Geometric Mean
169594|NCT00134719|Secondary|Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169595|NCT00134719|Secondary|rSBA-MenC Titers|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||titer||95% Confidence Interval|Geometric Mean
169596|NCT00134719|Secondary|Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values|The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.|After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)|Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169597|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-varicella Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
169598|NCT00134719|Primary|Number of Subjects With an Anti-rubella Seroresponse|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
169599|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-mumps Antibodies|"The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination.~ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent."|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
169600|NCT00134719|Primary|Number of Subjects Seroconverted for Anti-measles Antibodies|The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.|42 days after the fourth dose vaccination|Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.||Subjects|||Number
169631|NCT00133809|Primary|The Number of Insulin-Independent Subjects at One Year Following Islet Cell Transplantation|Independence from insulin injections is measured by the actual use of insulin by the study participants.|one year after transplant|||participants|||Number
169632|NCT00133705|Primary|Uterine Volume|Uterine volume is measured in mLs|6 months|||mL||Standard Deviation|Mean
169601|NCT00134719|Primary|Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169602|NCT00134719|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)|The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.|One month after the 3-dose primary vaccination course|Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.||Subjects|||Number
169603|NCT00134563|Secondary|Changes From Baseline in Fatigue Impact Scale [FIS] Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||units on a scale||Standard Error|Least Squares Mean
169604|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||mililiters (mL)||Standard Deviation|Mean
169605|NCT00134563|Other Pre-specified|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, baseline EDSS stratum and baseline number of Gd-enhancing T1-lesions as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||lesions per scan||95% Confidence Interval|Number
169606|NCT00134563|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.|baseline (before randomization) and 108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||mililiters (mL)||Standard Deviation|Mean
169607|NCT00134563|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.~Probability of disability progression at 24, 48 and 108 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||percent probability||95% Confidence Interval|Number
169608|NCT00134563|Primary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in EDSS score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|108 weeks|All randomized and treated participants; Participants were included in the treatment group to which they were originally assigned (intent-to-treat analysis).||relapses per year||95% Confidence Interval|Number
169609|NCT00134043|Primary|Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate."|Up to 3 years|Per RECIST (Response Evaluation Criteria in Solid Tumors)||percentage of participants|||Number
169675|NCT00132691|Secondary|Hyperlipidemia - Incident|LDL greater than or equal to 160 mg/mL|24 months|Number of participants at risk were included in the analysis||percentage of participants at risk||95% Confidence Interval|Number
169611|NCT00134004|Secondary|Graft Failure Rate|Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as <5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.|Cumulative incidence for the entire study, up to 11 years|||percentage of participants|||Number
169612|NCT00134004|Primary|Progression-free Survival|Percentage of participants who do not experience disease relapse, disease progression, or death.|2 years|||percentage of participants|||Number
169613|NCT00134004|Primary|Relapse Rate|Percentage of participants who experience disease relapse.|Cumulative incidence for the entire study, up to 11 years|||percentage of participants|||Number
169614|NCT00134004|Primary|Transplant-related Mortality|Percentage of participants who die for any reason other than recurrence of disease.|Cumulative incidence for the entire study, up to 11 years|||percentage of participants|||Number
169615|NCT00133978|Secondary|Hospital Length of Stay|Measure of the duration of the participant's hospital stay|6 months (from ICU admission)|||days||Inter-Quartile Range|Median
169616|NCT00133978|Secondary|ICU Acquired Infection|We have made some modifications the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) to operationalize the adjudication of infections in this trial. We grade the certainty of the diagnosis of infection using definitions for ‘Definite’, ‘Probable’, and ‘Possible’ for each category of infection. The categories of infection are: Deep surgical wound infection, Incisional (or superficial) surgical wound infection, Skin and soft-tissue infection (non-surgical) (SSTS), Catheter-related blood stream infections (CRI), Primary blood stream infections (BSI), Lower urinary tract infection, Upper urinary tract infection, Intra abdominal infection, Sinusitis, Lower respiratory tract infection (excluding pneumonia), ICU Acquired Pneumonia and Other.|Day 28|||participants|||Number
169617|NCT00133978|Secondary|ICU Length of Stay|Measure of the duration of participant stay in the ICU|Day 28|||days||Inter-Quartile Range|Median
169618|NCT00133978|Primary|28-day Mortality|28-day mortality/status: at 28 days after randomization;|Day 28|||participants|||Number
169619|NCT00133952|Secondary|Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24|Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||participants|||Number
169620|NCT00133952|Secondary|Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||participants|||Number
169621|NCT00133952|Secondary|Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24||Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||participants|||Number
169622|NCT00133952|Secondary|Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula||Baseline, up to 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements, last observation carried forward (LOCF).||micrometer (µm)||Standard Deviation|Mean
169623|NCT00133952|Secondary|Change From Baseline to Month 24 in Contrast Sensitivity|Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline contrast sensitivity measurements.||letters read correctly||Standard Error|Least Squares Mean
169624|NCT00133952|Secondary|Time to Focal Photocoagulation||Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline determination of focal photocoagulation treatment.||months||95% Confidence Interval|Median
169625|NCT00133952|Secondary|Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24|Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).|Baseline through 24 months|All randomized participants who took at least 1 dose of study drug and had post-baseline macular edema measurements.||Eyes|Participants||Number
169626|NCT00133952|Secondary|Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula|Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.|Baseline, 24 months|All randomized participants who took at least 1 dose of study drug and had both baseline and post-baseline retinal thickness measurements.||micrometer (µm)||Standard Error|Least Squares Mean
169627|NCT00133952|Primary|Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48|SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).|Baseline through 48 months|All randomized participants who took at least 1 dose of study drug and had post-baseline SMVL measurements.||percent of participants|||Number
169628|NCT00133809|Secondary|The Number of Subjects Exhibiting Fasting C-peptide Levels ≥ 0.5 ng/mL|Number of Participants With Endogenous Insulin Production Post-transplant, Assessed by Fasting C-peptide Levels at 1, 3, 6, 9,12,18, 24, 36, 48 and 60 months after islet cell transplantation|1, 3, 6, 9,12,18, 24, 36, 48 and 60 months post-transplantation|||participants|||Number
169629|NCT00133809|Secondary|Number of Subjects With HbA1C ≤ 6.5%|HbA1C was assessed in subjects 1, 3, 6, 9,12,18,24, 36, 48 and 60 months after transplantation and the number of subjects with values ≤ 6.5% was recorded which indicated better control of blood glucose levels.|1, 3, 6, 9,12,18,24, 36, 48 and 60 months post-transplantation|||participants|||Number
173476|NCT00096265|Secondary|Change in Functional Assessment of Cancer Therapy-Brain Subscale Questionnaire|Compared between two treatment arms using a two-group chi-squared test.|From randomization to three months.||||||
169633|NCT00133575|Secondary|Assessment of Dryvax Take Category|"Restricted to participants who received Dryvax 6-15 months after MVA. A take is a vesicle surrounded by a red areola which becomes umbilicated and then pustular before scabbing. Category 0=No take; Category 1=Significant modified take skin reaction; Category 2=Modified take skin reaction; Category 3=Primary take skin reaction"|3 weeks after Dryvax challenge|||Participants|||Number
169634|NCT00133575|Secondary|Peak Titer of Viral Shedding Post Dryvax Challenge|Median Dryvax virus titers as assessed from swabs of the vaccination site lesion taken at intervals until the vaccination site is scabbed. The maximum titer recovered during the sampling period for each participant is utilized in determining the median for the group.|Until vaccination site lesion has scabbed|||Titers||Full Range|Median
169635|NCT00133575|Secondary|Peak T-cell Gamma Interferon Responses (ELISPOT)|Median T-cell gamma interferon responses against the vaccinia virus as the assay antigen, as assessed by ELISPOT from sera collected 2 weeks after receipt of 2 doses. Responses are expressed as the number of spot forming units per 10^6 peripheral blood mononuclear cells (SFU/10^6 PBMC).|Approximately Day 42 after first vaccination|||SFU/10^6 PBMC||Inter-Quartile Range|Median
169636|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to Vaccinia|Median binding antibody titers against vaccinia virus as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
169637|NCT00133575|Secondary|Peak Binding Antibodies (ELISA) to ACAM3000 MVA|Median binding antibody titers against ACAM3000 MVA as the ELISA assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
169638|NCT00133575|Secondary|Peak Neutralizing Antibodies to Vaccinia|Median neutralizing antibody titers against vaccinia virus as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
169639|NCT00133575|Secondary|Peak Neutralizing Antibodies to ACAM3000 MVA|Median neutralizing antibody titers against ACAM3000 MVA as the assay antigen, as assessed from sera collected 2 weeks after receipt of 2 doses.|Approximately Day 42 after first vaccination|||Titers||Inter-Quartile Range|Median
169640|NCT00133575|Primary|Number of Participants With Signs of Possible Myopericarditis|Number of participants with signs of possible myopericarditis, either by clinical or laboratory (EKG, troponin) evaluation, at any time after vaccination for the during of the study|Within 360 days after vaccination|||Participants|||Number
169641|NCT00133575|Primary|Number of Participants With Urinalysis Laboratory Abnormalies After Vaccination|Number of participants with urinalysis laboratory abnormalies after vaccination, including proteinuria and hematuria by dipstick. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination|||Participants|||Number
169642|NCT00133575|Primary|Number of Participants With Enzymatic Clinical Laboratory Abnormalities After Vaccination|Number of participants with enzymatic clinical laboratory abnormalities after vaccination, including AST, ALT and alkaline phosphatase. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions|28 days after vaccination|||Participants|||Number
169643|NCT00133575|Primary|Number of Participants With Clinical Chemistry Laboratory Abnormalities After Vaccination|Number of participants with clinical chemistry laboratory abnormalities after vaccination, including total bilirubin and serum creatinine. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination|||Participants|||Number
169644|NCT00133575|Primary|Number of Participants With Hematologic Laboratory Abnormalities After Vaccination|Number of participants with hematologic laboratory abnormalities after vaccination, including hemoglobin, white blood cell count, neutrophil count and platelet count. Participants are counted only once for each parameter but may have experienced an abnormality of that parameter on multiple occasions.|28 days after vaccination|||Participants|||Number
169645|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Systemic Reactions|Number of participants reporting moderate or greater systemic reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination|||Participants|||Number
169646|NCT00133575|Primary|Number of Participants Reporting Moderate or Greater Solicited Local Reactions|Number of participants reporting moderate or greater local reactions solicited on the memory aid as well as by study personnel at follow up visits after either vaccination. Participants are counted only once but may have experienced symptoms on multiple occasions.|15 days after vaccination|||Participants|||Number
169647|NCT00132873|Primary|Vital Signs|Average Respiratory Rate at 1 year.|At 1 year|||Breaths per minute||Standard Deviation|Mean
169648|NCT00132873|Primary|Adverse Experiences|Number of Subjects with treatment-emergent adverse events.|continuous|||participants|||Number
169649|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum|Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.||ng/mL||Standard Deviation|Mean
169650|NCT00132808|Secondary|Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum|Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.||ng/mL||Standard Deviation|Mean
169651|NCT00132808|Secondary|Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum|Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.|Months 6, 12, 18 and 24|Intent to treat population with available data.||ng/mL||Standard Deviation|Mean
169652|NCT00132808|Secondary|Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.||Percentage change in BMD||Standard Error|Least Squares Mean
169653|NCT00132808|Secondary|Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.|The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).|Baseline, Month 24|Intent to treat population with available data.||Percentage change in BMD||Standard Error|Least Squares Mean
169654|NCT00132808|Primary|Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum|The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month – lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).|Baseline, Month 24|Intent to treat population. Last observation carried forward (LOCF) was utilized to impute missing data.||Percentage change in BMD||Standard Error|Least Squares Mean
169655|NCT00132769|Secondary|Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein|C-reactive protein levels rise in response to inflammation in the body. The ratio of On-treatment serum C-reative protein:Baseline serum C-reactive protein was calculated to determine a treatment effect. On-treatment C-reactive protein = the mean of serum C-reactive protein levels for Treatment Weeks 8, 10 and 12. A ratio of less than 1.0 is consistent with lower inflammation and was to be considered an improvement.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.||ratio||95% Confidence Interval|Least Squares Mean
169656|NCT00132769|Secondary|Patient's Assessment of Pain|"At each clinic visit, participants were to assess their amount of pain due to arthritis during the previous 48 hours on a 100 mm visual analog scale (VAS) that ranged from No pain (0) to Extreme pain (100). A lower score indicates less pain."|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
169657|NCT00132769|Secondary|Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index assesses participant functional ability based on 20 questions in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Responses range from 0=No disability to 3=Completely disabled. The score for each category subscale is the single response within the category with the highest score (greatest difficulty). The overall score for the Disability Index is the mean of the 8 category scores and also ranges from 0-3, with a lower score indicating less disability.|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
169658|NCT00132769|Secondary|Patient Global Assessment of Response to Therapy|Participants were to rate their overall response to the study drug on a 5-point Likert scale with grading as follows: 0=None, 1=Poor, 2=Fair, 3=Good, or 4=Excellent (scale range: 0-4). A higher score indicates a more positive response to study drug.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
169659|NCT00132769|Secondary|Investigator Global Assessment of Disease Activity|At each clinic visit, the Investigator was to make a global assessment of participant disease activity on a 5-point Likert scale with grading as follows: 1=Very well, 2=Well, 3=Fair, 4=Poor, or 5=Very poor (scale range: 1-5). A lower score indicates a more positive assessment of participant disease activity.|Treatment Week 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
169660|NCT00132769|Secondary|Patient Global Assessment of Disease Activity|"At each clinic visit, participants were to assess disease activity using a 100 mm visual analog scale (VAS) in reponse to the question: “Considering all the ways your arthritis affects you, mark an (X) through the line for how well you are doing.” The VAS ranges from Very Well (0) to Very Poor (100). The mean score at Treatment Weeks 8, 10 and 12 was calculated. A lower score indicates a better disease activity."|The average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
169661|NCT00132769|Secondary|Change From Baseline in Tender Joint Count|Tender joint count (TJC) was to be determined by assessing 68 joints (34 right side, 34 left side) for pain using the following grading system: 0=No pain, 1=Patient states that there is pain, 2=Patient states that there is pain and winces, or 3=Patient states that there is pain, winces, and withdraws. The total number of joints graded 1, 2, or 3 were then to be counted to yield the TJC. TJC ranges from 1-68, with increasing score indicating greater number of tender joints. TJC was to be averaged over weeks 8, 10, and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean TJC - Baseline TJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|No additional analyses were performed if the primary (Swollen Joint Count) and major secondary (ACR20) outcome measures resulted in a p-value of >0.05.|||||
169662|NCT00132769|Secondary|Percentage of Participants With American College of Rheumatology 20% Response [ACR20]|Participants were categorized as meeting ACR20 criteria when they had at least 20% improvement from Baseline in tender and swollen joint counts, and improvement from Baseline in at least 3 of 5 of the following domains: Pain Visual Analog Scale (VAS), Patient Global Assessement, Physician Global Assessment, Patient Physical Function (Disability) Score and acute-phase reactant (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]). The average percentage of participants that met the ACR20 responder criteria over Treatment Weeks 8, 10 and 12 was calculated.|Baseline and the average of Treatment Weeks 8, 10 and 12|The APT population consisted of all participants with a baseline and at least one postbaseline observation.||percentage of participants|||Number
169663|NCT00132769|Primary|Change From Baseline in Swollen Joint Count|Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.|Baseline and the average of Treatment Weeks 8, 10 and 12|The All Patients Treated (APT) population consisted of all participants with a baseline and at least one postbaseline observation.||score on a scale||95% Confidence Interval|Least Squares Mean
169740|NCT00131664|Primary|Mean Change From Baseline in A1C at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with a value at baseline and at Month 6 were analyzed.||percent||Standard Error|Mean
169664|NCT00132730|Secondary|Change From Baseline in Predose (Trough) Forced Vital Capacity (FVC)|FVC is a measure, in liters and using a spirometer, of the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. The values averaged during the placebo run-in period were used for the baseline measurement and the values averaged over Treatment Weeks 8, 10 and 12 were used for the on-treatment measurement. A higher value indicates greater lung exiratory function.|Predose at Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||liters||95% Confidence Interval|Least Squares Mean
169665|NCT00132730|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any change in symptoms or functional status that leads to administration (at investigator's discretion) of systemic corticosteroids (above participant's usual dose) and/or antibiotics, or an unscheduled COPD-related hospitalization, emergency room visit, or doctor visit. The number of participants who experienced at least one COPD exacerbation during the 12-week treatment period is reported.|Baseline through Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||participants|||Number
169666|NCT00132730|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response|The SOBQ is a validated 24-item measure of dyspnea associated with activities of daily living in patients with moderate to severe chronic lung disease. Twenty-one items ask patients about how frequently they experience shortness of breath (SOB) on a 6-point scale of 0 (never) to 5 (activity given up due to dyspnea) when performing various tasks. Three additional questions about limitations due to SOB, fear of harm from overexertion and fear of SOB are included for a total of 24 items. If patients do not routinely perform the activity indicated in the questionnaire, they are asked to estimate the degree of SOB anticipated. The SOBQ total score is calculated by summing responses across all 24 items. The total score ranges from 0 to 120, with a higher score indicating greater frequency of and limitations due to SOB. The score assessed at the baseline visit was used for the baseline score and the mean score assessed at Treatment Weeks 8 and 12 was used as the on-treatment score.|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
169667|NCT00132730|Secondary|Transition Dyspnea Index (TDI) Focal Score|The baseline dyspnea index (BDI) was measured at the randomization visit as a 3-domain score with a scale of 0 to 4 in each domain, with a total focal score of 12 indicating no dyspnea limitation and 0 indicating severe dyspnea. After 12 weeks of treatment, the investigator-administered TDI was completed, with a change in each of the 3 domains being rated from -3 (major deterioration) to +3 (major improvement), so that the TDI focal score could range from -9 to +9. A higher TDI focal score indicates improvement.|Baseline and Treatment Week 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
169668|NCT00132730|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response|"The SGRQ consists of 76 items in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impacts (social functioning, psychological disturbances resulting from airways disease). Scores for each domain and a total score are calculated; each questionnaire response has a unique empirically dervied weight. Scores range from 0 to 100, with higher scores indicating poor health. Each domain of the questionnaire is scored separately in 2 steps: 1) The weights for all items with a positive response are summed; 2) The score is calculated by dividing the summed weights by the maximum possible weight for that domain and expressing the results as a percentage. The mean SGRQ scores were calculated during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
169669|NCT00132730|Secondary|Change From Baseline in Total Daily Beta-agonist Use|The total daily beta-agonist use was measured in puffs per day and was recorded on daily diary cards by participants. It is defined as the sum of beta-agonist use between when participants arose from and went to bed. The total daily beta-agonist use values were the recorded mean during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment.|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||Puffs per day of beta-agonist||95% Confidence Interval|Least Squares Mean
169670|NCT00132730|Secondary|Change From Baseline in Overall Daytime Symptoms Score|"On a daily diary card, participants rated their responses to the question Overall, how much of the time did you have symptoms from your lung disease today? (0=none of the time; 5=all of the time). Scores range from 0 to 5, with higher scores indicating more time with symptoms. The overall daytime symptoms score value was the mean daily diary score during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment."|Baseline and Treatment Weeks 8, 10 and 12|The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.||score on a scale||95% Confidence Interval|Least Squares Mean
169671|NCT00132730|Primary|Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure, in liters, of the amount of air expired in 1 second. Measured values were averaged during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment. For participants who did not have any measurements over the last 4 weeks of the 12-week treatment period, the last available on-treatment measurement was carried forward.|Pre-dose at Baseline and Treatment Weeks 8, 10 and 12|The modified intention-to-treat (ITT) population includes all participants who had a baseline and at least one posttreatment measurement.||liters||95% Confidence Interval|Least Squares Mean
169672|NCT00132691|Secondary|Mortality||24 months|||percentage of participants||95% Confidence Interval|Number
169673|NCT00132691|Secondary|Diabetes Mellitus||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.||percentage of participants||95% Confidence Interval|Number
169674|NCT00132691|Secondary|Hypertension Diagnosis Requiring Treatment||24 months|Participants with prevalent complications or missing data at enrollment were excluded from the risk set.||percentage of participants||95% Confidence Interval|Number
169741|NCT00131573|Primary|Freedom From Major Complications||5 years|||Number of Adverse Events|||Number
169676|NCT00132691|Secondary|Change in SF-36 Physical Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The physical component score for the SF 36 is a summary measure of physical health primarily based on the physical functioning, role physical, bodily pain and general health domains of the survey. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group. A 3 to 5 point difference is considered to be clinically meaningful.|24 months|||units on a scale||Standard Error|Mean
169677|NCT00132691|Secondary|Change in SF-36 Mental Component Score From Baseline to 24 Months|Self-reported health related QoL was measured with the SF 36 survey. The mental component score for the SF 36 is a summary measure of mental health primarily based on the social functioning, role emotional, mental health and vitality domains. The score is scaled to a population norm with a mean of 50 and standard deviation of 10. Higher scores represent better outcomes. The mean change in scores between baseline and 24 months was calculated for each treatment group.|24 months|||units on a scale||Standard Error|Mean
169678|NCT00132691|Secondary|Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months|The NEI-VFQ 25 measures the effect of visual disability/symptoms with generic health and task-oriented domains. The range for the composite score is 0 to 100; higher scores are associated with better visual function. A change of 4 to 6 points is considered to be a clinically meaningful difference.|24 months|||units on a scale (composite score)||Standard Error|Mean
169679|NCT00132691|Secondary|Cataract - Incident Cataract||24 months|Eyes with uveitis, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
169680|NCT00132691|Secondary|Intraocular Pressure - IOP-lowering Surgery||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
169681|NCT00132691|Secondary|Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.|The percentage of subjects who used topical or systemic treatment for elevated IOP at any time during the 2 year follow-up and were not on IOP-lowering therapy at baseline is reported.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
169682|NCT00132691|Secondary|Glaucoma - Incident|Glaucoma was diagnosed by a glaucoma specialist through review of visual fields, clinical data, and fundus images.|24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
169683|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
169684|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
169685|NCT00132691|Secondary|Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg||24 months|Eyes, not participants, were analyzed. Eyes with prevalent complications or missing data at enrollment were were excluded from the risk set.||percentage of eyes with uveitis at risk|Participants|95% Confidence Interval|Number
169686|NCT00132691|Secondary|Uveitis Activity|Uveitis activity was determined by clinician assessment at each study visit. The study ophthalmologist evaluated each eye as active, inactive/never had uveitis or cannot assess.|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy).||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
169687|NCT00132691|Secondary|Macular Edema|center point macular thickness >= 240 micrometers assessed on OCT (Stratus OCT-3 [Carl Zeiss Meditec, Dublin, CA]) as graded by Central Reading Center|24 months|All eyes with uveitis were included in the analysis (245 eyes of the 129 participants randomized to implant therapy and 234 eyes of the 126 participants randomized to systemic therapy)..||percentage of eyes with uveitis|Participants|95% Confidence Interval|Number
169688|NCT00132691|Primary|Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis|Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.|24 months|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 255 randomized participants were used in the analytic model. 232 of the 255 completed the 2 year outcome visit."||letters||Standard Error|Mean
169689|NCT00132678|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS)|Measure of depression; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)||units on a scale||Standard Deviation|Mean
169690|NCT00132678|Secondary|Change in Young Mania Rating Scale (YMRS) Scores.|Measure of mania; score range 0 to 60 (lower score = less severity)|Baseline and Endpoint (last observation carried forward) of 24 month Double-Blind Period IV|Restricted to subjects with paired baseline and visit endpoint (Period IV) data only. Endpoint is the patient’s last nonmissing, postbaseline value in Period IV (last observation carried forward technique)||units on a scale||Standard Deviation|Mean
169691|NCT00132678|Primary|Number of Participants Who Had a Mood Relapse.|"Mood Relapse was defined as:~The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score >12 or a CGI-S score >4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator."|24 months|Intention to treat. 28 subjects from a Good Clinical Practice noncompliant site and 1 site with alleged research misconduct were excluded from efficacy analyses. The median (interquartile range) for time to relapse (d): Risperdal Consta: NA (173, NA) & Placebo: 219 (82, NA) [NA = not available; Risperdal Consta relapse percent < 50% & Placebo <75%]||Participants|||Number
169692|NCT00132496|Primary|Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group|Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.|8 weeks from randomization and end of treatment|Safety population (all patients who received at least one dose of study treatment) was the primary analysis population.||Participants|||Number
169693|NCT00132314|Primary|Hazard Ratio for Hospitalization|Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.|24 months|||participants|||Number
169694|NCT00132314|Primary|Hospitalization-free Survival - Time to Event|A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.|From randomization until date of first re-hospitalization, assessed up to 24 months|||years||95% Confidence Interval|Median
169695|NCT00132132|Primary|Percentage of Participants With BMI Reduction||Baseline, 12-15 months|Per protocol||percentage of participants|||Number
169696|NCT00132132|Primary|Change in BMI (Body Mass Index)||Baseline, 12-15 months|Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment||kg/m^2||95% Confidence Interval|Mean
169697|NCT00132028|Secondary|Overall Survival|Measured from date of registration to death, or last contact date|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing overall survival.||months||95% Confidence Interval|Median
169698|NCT00132028|Secondary|Progression-Free Survival|Measured from date of registration to date of first observation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.|after every 3 cycles on treatment, then every 6 months for 2 years, then annually for a total of 5 years.|All eligible patients who started treatment were included in assessing progression-free survival.||months||95% Confidence Interval|Median
169699|NCT00132028|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|after every 3 cycles on treatment|All patients who started treatment were included in assessing response estimates.||participants|||Number
169700|NCT00132002|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment to the time of documented progression, assessed up to 5 years|||Months||95% Confidence Interval|Median
169701|NCT00132002|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From the initial date of treatment to time of death, up to 5 years.|||Months||95% Confidence Interval|Median
169702|NCT00132002|Primary|Objective Tumor Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 8 weeks|||percentage of participants|||Number
169703|NCT00131937|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.|||months||90% Confidence Interval|Median
169704|NCT00131937|Secondary|Progression-Free Survival (PFS)|"PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as:~Appearances of any new lesions/sites during or after therapy~Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site~Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node >1.0 cm in its short axis"|Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years|||months||90% Confidence Interval|Median
169742|NCT00131573|Primary|Average Number of Voids Per Day||12 months|||Average Number of Voids||Standard Deviation|Median
169804|NCT00130039|Secondary|Number of Participants With Stroke Events|including nonfatal ischemic stroke, nonfatal hemorrhagic stroke and fatal stroke|upto 7 months after randomization|this outcome analysis performed on the intention to treat (ITT) method||participants|||Number
169705|NCT00131937|Primary|Overall Response (OR) Rate|"Response was assessed using the criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999). OR=complete response(CR)+complete response/uncertain(CRu)+partial response(PR) CR: 1)Disappearance of clinical/radiographic evidence of disease (dz) and all dz-related B-symptoms; normalization of biochemical abnormalities attributed to NHL; 2)Lymph nodes and nodal masses regress to normal size; 3)Spleen, if enlarged before therapy, has decreased in size and is not palpable; 4)Complete resolution of lymphoma in bone marrow biopsy CRu: Meet criteria 1 and 3 above but with ≥1 of the followings. Residual dominant nodal mass >1.5 cm in greatest diameter that has decreased by >75%. Indeterminate bone marrow.~PR: ≥50% decrease in SPD (sum of products of diameters) of 6 largest dominant nodes or nodal masses. No increase in size of liver or spleen. No unequivocal progression in nonmeasurable or nondominant sites. Splenic/hepatic nodules regress ≥50% in SPD. No new dz sites."|Assessed at the end of Cycle 2 and Cycle 6 (1 cycle = 28 days). Then every 3 months beginning Cycle 9 if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years.|||Proportion of participants||90% Confidence Interval|Number
169706|NCT00131911|Secondary|Duration of Response|Duration of response (DOR) was defined as the time from attaining a response (PR or CR) to the date of progression. Participants without progression were censored at the date of their most recent disease assessment. The median DOR was estimated using simple summary statistics.|Time from response to progression (up to 2 years)|There were 4 confirmed responses in Group A and 5 confirmed responses in Group B used in analyzing this endpoint.||months||Full Range|Median
169707|NCT00131911|Secondary|Progression Free Survival|Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST) as a 20% increase in the su of longest diameter of target lesions. Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Participants who were progression free were censored at the date of their most recent disease assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to progression or death (up to 2 years)|||months||95% Confidence Interval|Median
169708|NCT00131911|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|From registration to death (up to 2 years)|||months||95% Confidence Interval|Median
169709|NCT00131911|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of participants reporting a grade 3 or higher toxicity are reported.|Up to 2 years|||participants|||Number
169710|NCT00131911|Primary|Confirmed Response Rate|"Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients. > > Complete Response (CR) is defined as the disappearance of all target lesions. > Partial Response (PR) is defined as a 30% decrease in sum of longest diameter of target lesions; >~> We report the percentage of patients with a confirmed response and a 95% confidence interval estimated by the Duffy and Santner method."|Duration of Treatment (Up to 2 years)|Nine of the 50 carcinoid patients and 6 of the 42 Islet cell patients did not continue treatment past cycle 1. Therefore, these patients were not evaluated on consecutive cycles and were excluded from this endpoint.||percentage of participants||95% Confidence Interval|Number
169711|NCT00131885|Secondary|Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||IU/mL||Standard Deviation|Mean
169712|NCT00131885|Secondary|Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||pg/mL||Standard Deviation|Mean
169713|NCT00131885|Primary|Clearance (L/hr) of Levonorgestrel Over 24 Hours for Each Dosage Group and Each Study Session.|Average and standard deviation for Clearance (L/hr) of Levonorgestrel study for each dosage group and each study session.|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||L/hr||Standard Deviation|Mean
169714|NCT00131885|Secondary|Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses|"Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH).~Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo).~Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study)."|Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)|||IU/mL||Standard Deviation|Mean
169715|NCT00131885|Primary|Number of Participants With Progesterone Levels Above 3.0 ng/ml at Time 1 (Baseline) and Time 2 (After Intervention With St John's Wort or Placebo).|"Serum progesterone levels were drawn at the time of dosing with levonorgestrel and then at weekly intervals until menses occurred. This was done at Time 1 (baseline), and again at Time 2 (after 5 weeks of dosing with St. John's Wort or placebo).~Possible ovulation was defined as a serum progesterone >3ng/ml within 2 weeks of Days 9-12 of the menstrual cycle."|Progesterone levels drawn at weekly intervals after dosing with levonorgestrel between Days 9 and 12 of the menstrual cycle, at each time point until menses|||Participants|||Number
169716|NCT00131885|Primary|Area Under the Concentration Versus Time Curve for 0 to 24 Hours After Drug Administration, Done Between Days 9 and 12 of the Menstrual Cycle at Time 1 (Before) and Time 2 (During Treatment With St. John's Wort or Placebo)|"Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Serum samples drawn at 0, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, and 24 hours, following oral administration of a dose of levonorgestrel.~Treatment between the two time periods was with St. John's Wort or placebo herb, beginning after the Time 1 (baseline) and continued for 5 weeks until Time 2.~Estimates of levonorgestrel clearance were made using a two stage non-compartmental approach to determine individual and group parameters."|Area Under the Concentration versus Time curve for 0 to 24 hours after drug administration, between Days 9 and 12 of the menstrual cycle, done at Time 1 and at Time 2|||ng*hr/mL||Standard Deviation|Mean
169717|NCT00131677|Other Pre-specified|>5% Bone Mineral Density Decline at Femoral Neck|Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck.|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug. In addition, this analysis population includes only those participants for whom bone density analyses were performed.||percentage of participants|||Number
169718|NCT00131677|Primary|Clinical Safety--Hypophosphatemia|Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm), 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.||participants|||Number
169719|NCT00131677|Secondary|Behavioral Safety--Unprotected Anal Sex (UAS)|Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.|Nine months|||percentage of ppts reporting UAS|||Number
169720|NCT00131677|Secondary|Adherence to Study Drug|Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.|24 months (immediate arm) and 15 months (delayed arm)|||percentage of doses|||Number
169721|NCT00131677|Secondary|Number of Breakthrough HIV Infections|Number of participants with HIV seroconversions occuring while on study drug|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined which included only those participants who received study drug.||participants|||Number
169722|NCT00131677|Primary|Clinical Safety--Creatinine Elevations|Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)|24 months (immediate arm) and 15 months (delayed arm)|For biomedical outcomes, a treatment emergent cohort was defined. Participants entered the TE cohort with first dispense and exited with the first occurrence of: (1) completion of follow-up, (2) 30 days after permanent drug interruption, or (3) 30 days after last visit. For delayed arm participants,time before initiation of drug was excluded.||Participants|||Number
169723|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||µg/mL||Standard Error|Mean
169724|NCT00131664|Secondary|Mean Change From Baseline in Adiponectin at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. Adiponectin was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||microgram per millilitre (µg/mL)||Standard Error|Mean
169725|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 6. CRP was only done at baseline, months 6 and 12. The test was optional and performed only by participating sites.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||mg/dL||Standard Deviation|Mean
169726|NCT00131664|Secondary|Mean Change From Baseline in C-reactive Protein (CRP) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value. LOCF was not used for this analysis. CRP was only done at baseline, months 6 and 8. The test was optional and performed only by participating sites.|Baseline and Month 6|All Primary and secondary endpoints were calculated on the Intent to Treat (ITT) population where each patient had at least one dose of the medication and at least one valid observation. Missing values were carried forward (using Last Observation Carried Forward method) except for the calculation of the composite variables.||milligram per decilitre (mg/dL)||Standard Error|Mean
169727|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12|"Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2. The UKPDS (U.K. Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to HDL ratio at a specified visit.~The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||percent||Standard Error|Mean
171166|NCT00117598|Other Pre-specified|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to 5 years|ITT||months||95% Confidence Interval|Median
169728|NCT00131664|Secondary|Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6|"Change from baseline was calculated as the Month 6 value minus the baseline value, with LOCF from Month 2. The UKPDS (United Kingdom Prospective Diabetes Study) risk engine calculated was based on 5 years risk using gender, race, age at diagnosis of diabetes, duration of diabetes, smoking status, A1C, systolic blood pressure and total cholesterol to high-density lipoprotein (HDL) ratio at a specified visit.~The UKPDS cardiovascular disease (CVD) risk engine is used to estimate the risk of having coronary heart disease in type II diabetes according to the UKPDS model. The possible risk scores can range from 0 to 100% and hence lower scores would predict a person is less likely to have an event."|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||percent||Standard Error|Mean
169729|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 12|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||participants|||Number
169730|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 6|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 6 with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||participants|||Number
169731|NCT00131664|Secondary|Number of Subjects Achieving FPG Target at Month 4|FPG responders were described as subjects having achieved FPG less than 7 mmol/L at Month 4 with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||participants|||Number
169732|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with LOCF from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||millimoles per litre (mmol/L)||Standard Error|Mean
169733|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6|Change from baseline was calculated as the Month 6 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 6 were analyzed.||millimoles per litre (mmol/L)||Standard Error|Mean
169734|NCT00131664|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||millimoles per litre (mmol/L)||Standard Error|Mean
169735|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 12|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 12 with LOCF from Month 2.|Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||participants|||Number
169736|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 6|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 6, with LOCF from Month 2.|Month 6|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline Month 6 were analyzed.||participants|||Number
169737|NCT00131664|Secondary|Number of Subjects Achieving A1C Target at Month 4|A1C responders were described as subjects having achieved A1C less than 7 percent at Month 4, with LOCF from Month 2.|Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||participants|||Number
169738|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 12|Change from baseline was calculated as the Month 12 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 12|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 12 were analyzed.||percent||Standard Error|Mean
169739|NCT00131664|Secondary|Mean Change From Baseline in A1C at Month 4|Change from baseline was calculated as the Month 4 value minus the baseline value, with last on-treatment observation carried forward (LOCF) from Month 2 for withdrawn subjects or missing values.|Baseline and Month 4|Intent-to-Treat (ITT) population: all randomized subjects who took at least one dose of study medication and had at least one valid observation. For withdrawn subjects or missing values, the last on-treatment observation was carried forward (LOCF). Only subjects with values at baseline and Month 4 were analyzed.||percent||Standard Error|Mean
169743|NCT00131508|Secondary|Change in Hand Grip From Baseline to 12 Months.|"To investigate the clinical effects of oral glutamine and placebo on hand grip in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.~Hand grip strength is a measure of muscle strength.Units are measured in Kg.Muscle strength is measured using a hydraulic hand-held dynamometer.Change was defined as 12 Month measure minus baseline.Muscle strength is measured using the hand grip strength via a hydraulic hand-held dynamometer (Kg)."|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||kg||Full Range|Median
169744|NCT00131508|Secondary|Change in Pulse Rate From Baseline to 12 Months|To investigate the clinical effects of oral glutamine and placebo on pulse rate in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Beats per minute (BPM)||Full Range|Median
169745|NCT00131508|Secondary|Change in Weight Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on weight in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Basline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Percentile||Full Range|Median
169746|NCT00131508|Secondary|Change in Height Percentile From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height percentile in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Percentile||Full Range|Median
169747|NCT00131508|Secondary|Change in Height Z-score From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on height Z-score in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.|Baseline and 12 months|Analyzed patients had a height measurement at both baseline and 12 months.||Z-score||Full Range|Median
169748|NCT00131508|Secondary|Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports.|Evaluation of quality of life at baseline and 12 months in the glutamine versus placebo group using the PedsQL Version 4.0 inventory. This instrument measures individual well being across physical, emotional, social, and school function categories using patient self-reports and/or parent reports. The tool contains a 15-question, age-specific, self-report inventory (for children age 5-7 years, 8-12 years, and 13-18 years) and a corresponding parent inventory. Lower scores indicate a better quality of life.|Baseline and 12 Months|||Units on a scale||Full Range|Median
169749|NCT00131508|Secondary|Change in Red Blood Cell Glutamine From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo in children with Sickle Cell Anemia (SCA) by comparing the difference in the levels of red blood cell glutamine between baseline and 12 months of treatment in the two groups.|Baseline and 12 months|||nmol/mg creatinine||Full Range|Median
169750|NCT00131508|Secondary|Change in Body Mass Index From Baseline to 12 Months|To investigate the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes (BMI) between baseline and 12 months of treatment in the two groups.|Baseline and 12 months|||kg/m2||Full Range|Median
169751|NCT00131508|Primary|Change in Resting Energy Expenditure From Baseline to 12 Months|To compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months. REE was measured by indirect calorimetry, using a metabolic cart.REE Ratio =(REE Measured/REE Predicted)x 100).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.The REE Ratio was evaluated at baseline and 12 months.The REE Ratio is calculated as (REE Measured / REE Predicted) x 100).REE units are measured as (Kcal / day).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.|Baseline and 12 months|||REE ratio||Full Range|Median
169752|NCT00131456|Primary|Two Consecutive Weeks of Marijuana Abstinence|The primary outcome measure for marijuana use was a dichotomous abstinence response,defined as at least two consecutive urine-confirmed abstinent weeks. Each week during the study, subjects were scored as urine-confirmed abstinent if both self-reported marijuana use for that week was negative, according to the quantitative substance use daily inventory (Timeline FollowBack), and all urines collected for that week were negative for THC. Patients who achieved the two consecutive abstinent weeks were classified as abstinent whether or not they subsequently dropped out of the study. Patients who dropped out of the study without achieving two continuous weeks of abstinence were classified as not abstinent.|measured daily by self report for 12 weeks of the trial or length of study participation|All analyses were conducted based on the intent-to-treat principle.||participants|||Number
169753|NCT00131378|Primary|Abdominal Fat|6 month change in visceral abdominal fat (primary body composition endpoint)|Measured at baseline and month 6|||cm^2||Standard Error|Mean
169754|NCT00131378|Primary|Total Abdominal Fat|6 month change in total abdominal fat (primary body composition endpoint)|Measured at baseline and month 6|||cm^2||Standard Error|Mean
169755|NCT00131378|Secondary|Insulin-like Growth Factor-1 (IGF-1) Levels|6-month change in IGF-1 levels|Measured at baseline and month 6|||ng/mL||Standard Error|Mean
169756|NCT00131378|Secondary|Measure of Insulin Resistance|6 month change in 2-hour glucose (primary insulin resistance endpoint)|Measured at baseline and month 6|||mg/dL||Standard Error|Mean
169757|NCT00131378|Primary|HsCRP|6 month change in HsCRP (primary cardiovascular risk endpoint)|Measured at baseline and month 6|ITT||mg/L||Standard Error|Mean
169758|NCT00131352|Secondary|Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26|"Participants were classified as a positive responder if at least one of the following two conditions were met:~A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR~Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU"|Week 26|Intent-To-Treat (ITT) population.||participants|||Number
169759|NCT00131352|Secondary|Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26|The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population||participants|||Number
169760|NCT00131352|Secondary|Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26|The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.|Week 26|Intent-To-Treat (ITT) population||participants|||Number
169761|NCT00131352|Secondary|Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, Week 26|Intent-To-Treat (ITT) population.||units on a scale||Standard Error|Mean
169762|NCT00131352|Secondary|Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0–4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.|Day 0, up to week 26|Intent-To-Treat (ITT) population.||units on a scale||Standard Error|Mean
169763|NCT00131352|Secondary|Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale|Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.|Week 26|Intent-To-Treat (ITT) population||participants|||Number
169764|NCT00131352|Secondary|Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.|Day 0, Week 26|Intent-To-Treat (ITT) population.||units on a scale||Standard Error|Mean
169765|NCT00131352|Primary|Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale|The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0–4, where 0=no pain and 4=extreme pain.|Day 0, up to week 26|Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.||units on a scale||Standard Error|Mean
169766|NCT00131248|Primary|Bradycardia Episodes/Day||7 days|18 participants originally enrolled, 1 withdrew, leaving 17 participants analyzed.||episodes per day||Standard Deviation|Mean
169767|NCT00130923|Secondary|Clinical Symptoms, Global Functioning, Cognition, and Extrapyramidal System Effects||6 months||||||
169768|NCT00130923|Secondary|Other Substance Use as Assessed by the Timeline Followback Scale||6 months||||||
169769|NCT00130923|Primary|Mean Heavy Drinking Days Per Week||6 months|||Drinking days per week||Standard Deviation|Mean
169770|NCT00130832|Primary|Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered|Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|"Per Protocol Population~For serotype G4 the RotaTeq and Oral Poliovirus (OPV) concomitantly group N = 350"||GMT||95% Confidence Interval|Geometric Mean
169771|NCT00130832|Primary|GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered|Approximately 42 days Postdose 3|Per Protocol Population||GMT||95% Confidence Interval|Geometric Mean
169772|NCT00130832|Primary|Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3|GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.|Approximately 42 days Postdose 3|The primary immunogenicity analyses were based on evaluable per-protocol subjects who received all scheduled doses, were not protocol violators, and had valid assay values.||Geometric Mean Titer (GMT)||95% Confidence Interval|Geometric Mean
169773|NCT00130793|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination|GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination|From prevaccination (baseline) to 4 weeks postvaccination|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.||gpELISA units/mL||95% Confidence Interval|Geometric Mean
169774|NCT00130793|Secondary|Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination|Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|4 weeks|All vaccinated subjects with safety follow-up are included.||Participants|||Number
169775|NCT00130793|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination|The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.|4 weeks|The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)||gpELISA units/mL||95% Confidence Interval|Geometric Mean
169776|NCT00130780|Primary|The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment.|These criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A > 25% and < 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas|2 years|||participants|||Number
169777|NCT00130728|Secondary|Duration of Objective Response|Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.|Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)|Patients with an objective response||months||95% Confidence Interval|Median
169778|NCT00130728|Secondary|Percentage of Participants With Objective Response|Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.|The median duration of Objective response was up to 9.7 months|Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.||Percentage of participants||95% Confidence Interval|Number
169779|NCT00130728|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.|From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)|Randomized patients||months||95% Confidence Interval|Median
169780|NCT00130728|Primary|Overall Survival (OS) Among All Randomized Patients|Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.|From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)|Randomized patients||months||95% Confidence Interval|Median
169781|NCT00130689|Primary|Overall Response Rate|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 weeks (range 1-23 weeks).|Responses were determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.||proportion of paticipants||90% Confidence Interval|Number
169782|NCT00130637|Primary|Number of Participants Reporting a Serious Adverse Event (SAE)|Safety of acute daclizumab use in JIA-associated uveitis was assessed through serious adverse events (SAE).|52 weeks|||participant|||Number
169783|NCT00130637|Primary|Number of Participants With a Two-step Reduction in Inflammation|Number of participants with a two-step reduction (or down to 0 out of a scale of 0 to 4+) of anterior chamber (AC) inflammation according to Standardization of Uveitis Nomenclature (SUN) criteria, while on a topical corticosteroid schedule of less than 3 times a day. Grade 0 is the best score on this scale with <1 cell in the field and 4+ is the worst score on this scale with >50 cells in the field.|12 weeks|||participants|||Number
169784|NCT00130520|Primary|Median Response Duration (Weeks)|Response duration=time (in weeks) between date of measurable response and date of progression (progression=20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in opinion of treating physician, any new lesion/site, death due to disease)if known or the date the subject went off protocol if they were still considered responders (ie do not qualify as progression) or are stable (Does not qualify for CR, PR, progression or Symptomatic Deterioration)|1 week to 96 weeks|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.||weeks||Full Range|Median
169785|NCT00130520|Secondary|Progression Free Survival(PFS)|PFS was defined as the time from the start of therapy to the time of the first documentation of progression(progression=20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, Death due to disease), symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause;|June 2005 to October 5, 2009|The population analyzed included all participants receiving at least 1 dose of study intervention and at least one assessment post-baseline. One subject was not evaluable. Analysis was per protocol||months||Full Range|Median
169801|NCT00130039|Secondary|Numbers of Fatal or Major Bleeding Complications|life-threatening or fatal bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood|upto 7 months after randomization|this outcome analysis was done ITT method||events|||Number
169786|NCT00130520|Primary|Objective Response (Complete Partial, Stable and Progression)|Objective response was defined using standard RECIST criteria. CR(complete response)= disappearance of all target lesions PR(partial response)=30% decrease in the sum of the longest diameter of target lesions PD(progressive disease)=20% increase in the sum of the longest diameter of target lesions SD(stable disease)= small changes that do not meet above criteria|06.16.2005 to 10.05.2009|Population=subjects receiving 1 dose of intervention and one assessment post-baseline. One subject=not evaluable. Analysis-Enroll 40, initial accrual of 20. If ≤1 confirmed responses observed in 20=closure. If ≥2 responses=20 additional.||Participants|||Number
169787|NCT00130286|Secondary|Change in Subcutaneous Adipose Tissue Volume|"Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI~Data are presented only for subjects who had MRI scans done at both time points."|12 weeks|||L||Standard Deviation|Mean
169788|NCT00130286|Secondary|Change in Visceral Adipose Tissue Volume|"Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI~Data are presented only for subjects who had MRI scans done at both time points."|12 weeks|||L||Standard Deviation|Mean
169789|NCT00130286|Primary|Change in Insulin Sensitivity|"Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test~This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points."|12 weeks|||uU*10^-4*min*ml^-1||Inter-Quartile Range|Median
169790|NCT00130247|Secondary|Microbiologic: Time After Inoculation Until Culture Positive in BACTEC 460 or MGIT 960 Enriched Liquid Media After 2 Months in Treatment - Results Are Pending||Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 24, and 30||||||
169791|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.||Participants|||Number
169792|NCT00130247|Secondary|Microbiologic: Changes in Sputum Mycobacterial mRNA - Results Are Pending||At 1 and 2 months of anti-TB treatment, and upon relapse||||||
169793|NCT00130247|Secondary|Immunologic: Changes in Sputum Cytokine Levels - Results Are Pending||After 1 and 2 months of anti-TB treatment||||||
169794|NCT00130247|Secondary|Immunologic: Store Peripheral Blood Mononuclear Cells (PBMC) - Results Are Pending||Pre-treatment and serum pre-treatment after 2 and 6 months of anti-TB treatment, and at the time of relapse for future immunologic analysis||||||
169795|NCT00130247|Secondary|Immunologic: Changes in Cytokine Levels in Mycobacterium Tubercolosis (MTB) Antigen-stimulated Whole Blood Culture Supernatants - Results Are Pending||After 2 and 6 months of anti-TB treatment and upon relapse||||||
169796|NCT00130247|Secondary|Acquired Drug Resistance in Patients Who Relapsed||2 years|This analysis was per protocol and looked for acquired drug resistance among the 13 patients in the 4-Month Arm who relapsed and the 3 patients in the 6-Month Arm who relapsed.||Participants|||Number
169797|NCT00130247|Secondary|Relapses at 1 and 2 Years||1 and 2 years after successful completion of initial anti-TB treatment|Analysis includes the 386 patients who received the intervention, completed treatment, and started post-treatment follow-up (193 patients in each treatment arm). Two subjects were lost after completing treatment and contributed no follow-up time, and 6 subjects did not receive the intervention so were not included in the analysis.||Participants|||Number
169798|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.||Participants|||Number
169799|NCT00130247|Secondary|Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat|A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.|2 years|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.||Participants|||Number
169800|NCT00130247|Primary|Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat|Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.|30 months|The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.||Participants|||Number
169805|NCT00130039|Secondary|Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI|number of patients with new ischemic lesions on FLAIR (Fluid attenuation inversion recovery) images of follow-up MRI, which were determined by slice to slice comparison with baseline MRI.|7 months after treatment|this analysis included the patients who had performed follow-up FLAIR imaging||pariticipants|||Number
169806|NCT00130039|Primary|Number of Participants With Progression of Symptomatic Intracranial Stenosis|"Blind reviewers classified the presence and severity of stenosis on middle cerebral arteries and basilar artery on magnetic resonance angiogram (MRA) into 5 grades; normal, mild, moderate, severe and occlusion. Progression was defined as worsening of stenosis by 1 or more grades on final MRA as compared with the baseline MRA.~The progression of symptomatic stenosis is defined as 1 or more grade worsening of the stenosis on the symptomatic artery on MRA."|7 months after treatment|||participants|||Number
169807|NCT00129961|Secondary|Spot Urine Protein:Creatinine Ratio|Subjects’ urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. Available data, no imputations.||ratio (mg/mg)||Full Range|Median
169808|NCT00129961|Secondary|Number of Subjects With Biopsy-Confirmed Acute Rejection||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||subjects|||Number
169809|NCT00129961|Secondary|Graft Survival Measured by Graft Loss|Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||graft loss|||Number
169810|NCT00129961|Secondary|Number of Participants That Died||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
169811|NCT00129961|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass.|At 24 months (Week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. All available data, no imputations.||μmol/L||Standard Deviation|Mean
169812|NCT00129961|Secondary|Nankivell-Calculated Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.|At 24 months (week 104)|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. For the intention to treat analysis, a GFR of 0 was imputed for graft loss or death, and last observation carried forward (LOCF) for missing values.||units on scale||Standard Deviation|Mean
169813|NCT00129961|Secondary|Number of Subjects Who Discontinue Assigned Therapy||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
169814|NCT00129961|Secondary|Death Due to NMSC||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
169815|NCT00129961|Secondary|Subjects Reporting Incidence of Metastatic Disease Related to NMSC.|The number of subjects with metastatic disease related to NMSC.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
169816|NCT00129961|Secondary|Number of Recurrent NMSC Lesions Per Subject-year|Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||lesions per participant year|||Number
169817|NCT00129961|Secondary|Grade Distribution of NMSC Lesions|Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
169818|NCT00129961|Secondary|Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)||up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||Percentage of Participants|||Number
169819|NCT00129961|Secondary|Number of Lesion Free Subjects|The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||participants|||Number
169820|NCT00129961|Secondary|Time to First Biopsy Confirmed New NMSC Lesion.|The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||number of days||95% Confidence Interval|Median
169821|NCT00129961|Primary|New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year|The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.|up to 24 months|Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up.||Standardized Yearly Rate of NMSC|||Number
169822|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4|Mean serum concentrations of motavizumab at 30 days post Dose 4|30 days post Dose 4|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements||ug/mL||Standard Deviation|Mean
169823|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3|Mean serum concentrations of motavizumab at 30 days post Dose 3|30 days post Dose 3|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements||ug/mL||Standard Deviation|Mean
169824|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2|Mean serum concentrations of motavizumab at 30 days post Dose 2|30 days post Dose 2|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements||ug/mL||Standard Deviation|Mean
169825|NCT00129766|Secondary|The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1|Mean serum concentrations of motavizumab at 30 days post Dose 1|30 days post Dose 1|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements||ug/mL||Standard Deviation|Mean
169826|NCT00129766|Secondary|The Serum Concentrations of Motavizumab at Day 0|Mean serum concentrations of motavizumab at Day 0|Day 0|The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug.||ug/mL||Standard Deviation|Mean
169827|NCT00129766|Secondary|The Number of Participants With Anti-motavizumab Antibodies|Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10.|Day 0 - 120|N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217||participants|||Number
169828|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended OM Infections|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||number of prescriptions||Standard Deviation|Mean
169829|NCT00129766|Secondary|The Frequency of Prescribed Antibiotics for Medically-attended LRI|The average number of presciptions per event per subject was summarized for each treatment group.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Number of prescriptions||Standard Deviation|Mean
169830|NCT00129766|Secondary|The Incidence of Medically-attended Otitis Media (OM) Infections|Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event.|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Participants|||Number
169831|NCT00129766|Secondary|The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups|The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization.|Days 0 - 150|Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint.||Participants|||Number
169832|NCT00129766|Secondary|The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI)|LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms.|Day 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Participant|||Number
169833|NCT00129766|Primary|Number of Participants Reporting Changes in Vital Signs From Baseline|Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169834|NCT00129766|Primary|Number of Participants Who Died||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169835|NCT00129766|Primary|Number of Participants Who Discontinued Study Drug Due to AEs||Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169836|NCT00129766|Primary|Number of Participants Reporting AEs by Highest Severity Grade|Adverse events events were graded by severity; Level 1, 2, 3, or 4|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169837|NCT00129766|Primary|Number of Participants Reporting Any Related SAEs|Number of participants reporting one or more SAEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169838|NCT00129766|Primary|Number of Participants Reporting Any Serious Adverse Events (SAEs)|Number of participants reporting one or more SAEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169839|NCT00129766|Primary|Number of Participants Reporting Any Related AEs|Number of participants reporting one or more AEs considered related to study drug by the investigator|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169840|NCT00129766|Primary|Number of Participants Reporting Any Adverse Events (AEs)|Number of participants reporting one or more AEs|Days 0 - 150|The Safety Population included all patients who received any study drug and had any safety follow-up.||participants|||Number
169841|NCT00129766|Primary|Incidence of RSV Hospitalization (Includes Deaths by RSV)|RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence).|Days 0 - 150|The Intent-to-Treat (ITT) Population included all patients randomized into the study.||Participants|||Number
169842|NCT00129727|Secondary|Toxicity|Per CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study|60 months|||Participants|||Number
169843|NCT00129727|Secondary|Response Rate (RECIST-1)|To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.|5 years|||Percentage of Participants||95% Confidence Interval|Number
169844|NCT00129727|Primary|PFS|Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer|Median PFS in months - up to 5 years|||Months||95% Confidence Interval|Median
169845|NCT00129623|Secondary|Number of Participants With Marked Laboratory Abnormalities|Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].|Screening up to 12 months|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.||participants|||Number
169846|NCT00129623|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 15 days after end of study treatment (Approximately 2 years)|The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.||participants|||Number
169847|NCT00129623|Secondary|Percentage of Responders|Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.|Up to 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||Percentage|||Number
169848|NCT00129623|Secondary|Absolute Change From Baseline in sCTX|Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6, 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.||ng/ml||95% Confidence Interval|Median
169849|NCT00129623|Secondary|Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)|Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.|Baseline and 3, 6 and 12 months|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.||Percentage||95% Confidence Interval|Median
169850|NCT00129623|Secondary|Absolute Change From Baseline in BMD of the Proximal Femur at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||g/cm^2||Standard Deviation|Mean
169851|NCT00129623|Secondary|Relative Change From Baseline in Mean Proximal Femur BMD at Month 12|BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||Percentage||Standard Deviation|Mean
170549|NCT00123604|Primary|Flow Mediated Dilation|Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.|change from baseline to 5 months|||percentage of change in dilation||Standard Deviation|Mean
169852|NCT00129623|Secondary|Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||g/cm^2||Standard Deviation|Mean
169853|NCT00129623|Primary|Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12|BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)|Baseline and Month 12|The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.||Percentage||Standard Error|Least Squares Mean
169854|NCT00129545|Secondary|Procedure Success|Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.|Initial implant procedure|14 subjects did not have an implant procedure attempted||percentage of implant attempts|||Number
169855|NCT00129545|Primary|The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events|Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.|5 years|"Event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics~Roll-in subjects were not included in the primary outcome analysis per study design."||Events per 100 pt-yrs||95% Confidence Interval|Number
169856|NCT00129545|Primary|Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death|A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)|5 years|"event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years) total patient years 2717, 95% Credible Intervals per predefined Bayesian Statistics~Roll-in subjects were not included in the primary outcome analysis per study design."||events per 100 pt yrs||95% Confidence Interval|Number
169857|NCT00129480|Secondary|Depression Severity (Patient Health Questionnaire-depression Rating Scale at 6 and 12 Months); Clinician Adherence to Clinical Guidelines for Chronic Pain (Chart Review Conducted at 12 Months); Patient and Provider Satisfaction Questionnaires Completed||baseline, 3 month, 6 month, 12 month||||||
169858|NCT00129480|Primary|Pain-related Function (Roland Disability Score) at 12 Months|The Roland Morris Disability Questionnaire has 24 yes or no items. Each item is scored as 0 or 1. Item scores or summed to create total score with range 0 to 24. Higher scores represent greater disability. the Roland Morris has been widely used, has content and construct validity, internal consistency, and responsiveness to change among patients with chronic pain.|12 months|||Adjusted percent change||95% Confidence Interval|Mean
169859|NCT00129467|Primary|Days to Remission of Depression|Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.|18 Days|The number of participants analyzed is the number of who received the intervention||Days||Standard Error|Mean
169860|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex|"The Delayed Memory Index consists of verbal and nonverbal recall tasks (words, drawings) that the subject views early in the evaluation and without warning, is asked to recall ~1/2 hr later. Scores are expressed as standardized scores normalized to a population mean of 100, with a standard deviation of 15 (possible scores between 40-135). Higher scores reflect better performance. Subjects received the A form at baseline and wk-4 visit and the B form at the wk-2 visit (A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.||Standard Score||Standard Deviation|Mean
169861|NCT00129441|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score|"Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. All subjects received the A form at baseline and the wk-4 visit and the B form at the wk-2 visit (the A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects)."|Week 4|One subject dropped out before completing the study.||Standard Score||Standard Deviation|Mean
169862|NCT00129441|Secondary|Brief Psychiatric Rating Scale Total Score|The Brief Psychiatric Rating Scale-anchored (BPRS; Overall and Gorham, 1962; Woerner, Mannuzza, Kane, 1988) is an 18-item scale that is among the most widely used measure of psychopathology. Scores range from 1-7, with higher scores reflecting greater pathology. A total score is derived from the sum of all 18 items (possible scores range from 18-126). It relies on clinical judgment in the assessment of key areas of psychopathology (depression, anxiety, psychosis).|Week 4|One subject dropped out prior to completing study||Scores on a scale||Standard Deviation|Mean
169863|NCT00129441|Primary|Preparing to Overcome Prepotency Task - Error Rate|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4|||proportion of errors||Standard Deviation|Mean
169864|NCT00129441|Primary|Preparing to Overcome Prepotency (POP) Task - Reaction Time|The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.|Week 4|||msec||Standard Deviation|Mean
169865|NCT00129441|Primary|AX Continuous Performance Test Task D-prime|For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.|Week 4|Four subjects did not complete a sufficient number of trials for the AXCPT task at both testing periods, therefore 7 L-830982 and 4 placebo subjects data were analyzed.||d-prime||Standard Deviation|Mean
169866|NCT00129441|Primary|N-back Task - Error Rate|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.||proportion of errors||Standard Deviation|Mean
169867|NCT00129441|Primary|N-back Task - Reaction Time|The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.|Week 4|Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.||msec||Standard Deviation|Mean
169868|NCT00129402|Secondary|Percent Change From Baseline in HDL-C||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
169869|NCT00129402|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
169870|NCT00129402|Secondary|Percent Change From Baseline in Triglycerides (TG)||baseline to 6 weeks|ITT||percent change||Standard Deviation|Median
169871|NCT00129402|Secondary|Percent Change From Baseline in Non High-density Lipoprotein Cholesterol (Non HDL-C)||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
169872|NCT00129402|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||baseline to 6 weeks|ITT||percent change||Standard Error|Least Squares Mean
169873|NCT00129402|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Least squares mean percent change from Baseline in LDL-C at the end of Step 1 (Week 6) in the pooled groups who received ezetimibe plus simvastatin compared with pooled groups who received simvastatin monotherapy|baseline to 6 weeks|The analysis was performed on the intent to treat (ITT) population. Although 248 subjects received randomized treatment, two of the subjects did not have at least one baseline and at least one postbaseline lipid determination and thus could not be analyzed in the ITT population. Therefore, the actual ITT population consisted of 246 subjects.||percent change||Standard Error|Least Squares Mean
169874|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||Week 8|||participants|||Number
169875|NCT00129311|Primary|7 Day Point Prevalence of Cigarette Abstinence||6-month follow up|||participants|||Number
169876|NCT00129259|Secondary|Change in Average Total Insulin Dose Per Body Weight|This measure is computed using the average amount of exogenous insulin taken per day for the 3 days prior to the visit. The average insulin use is divided by the subject's weight in kilograms (kg). The need for lower dose(s) of prescribed exogenous insulin while maintaining optimal control of a subject's diabetes reflects improved management of the underlying disease.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data||Units of Insulin/kilogram/day (U/kg/day)||Standard Deviation|Mean
169877|NCT00129259|Secondary|Change in HbA1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time and measures the level of optimal management of underlying disease. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).A decline in HbA1c from baseline to month 24 signifies an improvement in diabetic control. The goal of treatment: to maintain the HgA1c level as close to normal as possible without frequent occurrence of hypoglycemia.|Baseline (Pre-treatment), Month 24|Intent-to-treat with available data||Percentage (%)||Standard Deviation|Mean
169878|NCT00129259|Primary|Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)|C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results are imputed using a conservative scenario.|Baseline (Pre-treatment), Month 24|Intent-to-treat||pmol/mL||95% Confidence Interval|Least Squares Mean
169879|NCT00129246|Primary|Weight Gain|Weight gain for for the entire sample in pounds at 6 weeks.|Week 6|Per protocol analysis||lbs||Standard Deviation|Mean
169880|NCT00129246|Secondary|Weight Gain Abstinent Participants|Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.|Week 6|Per protocol analysis||lbs||Standard Deviation|Mean
169881|NCT00129246|Primary|Point Prevalence Abstinence|Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.|Week 6|Per protocol analysis||participants|||Number
169882|NCT00129246|Primary|Smoking Cessation|Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.|Week 6|Per protocol analysis||participants|||Number
169883|NCT00129220|Secondary|Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score|Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).|Baseline to 6 weeks|Participants in the Safety Analysis Set (participants who had baseline and post-baseline measurements). Participants were included in the treatment group for which they actually received treatment.||units on a scale||Standard Deviation|Mean
169884|NCT00129220|Secondary|Percentage of Participants Who Switched to Syndromic Depression|Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had manic (not mixed) episode at baseline.||percentage of participants|||Number
169885|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)|Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
169886|NCT00129220|Secondary|Percentage of Participants Who Switched to Symptomatic Depression|Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|3 weeks, 6 weeks|Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had HAMD-17 total scores ≤7 at baseline.||percentage of participants|||Number
169887|NCT00129220|Secondary|Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||percentage of participants|||Number
169888|NCT00129220|Secondary|Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks|Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||percentage of participants|||Number
169889|NCT00129220|Secondary|Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 3 weeks, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
169890|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness|A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
169891|NCT00129220|Secondary|Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)|Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.|6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||percentage of participants|||Number
169892|NCT00129220|Secondary|Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 6 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
169893|NCT00129220|Primary|Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline, 3 weeks|Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.||units on a scale||Standard Deviation|Mean
169894|NCT00129129|Secondary|Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)|Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).|Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169895|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169896|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169897|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169898|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169899|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period following the fourth dose|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169900|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. “Any”= any report of the specified symptom irrespective of intensity and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; “Grade 3” for Drowsiness, Irritability/Fussiness = prevented normal activity; “Grade 3” Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); “Grade 2 or 3” for fever = T >39.0°C; “Grade 3” for fever = T >40.0°C|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169901|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. “Any”= any report of the specified symptom irrespective of intensity and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; “Grade 3” for Drowsiness, Irritability/Fussiness = prevented normal activity; “Grade 3” Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); “Grade 2 or 3” for fever = T >39.0°C; “Grade 3” for fever = T >40.0°C|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169902|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. “Any”= any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling >10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling >30 mm; “Grade 2” limb circumference (LC) = LC >20 mm; “Grade 3” LC = LC >40 mm|Within 8 days (Day 0-7) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.||Subjects|||Number
169903|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. “Any”= any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling >10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling >30 mm; “Grade 2” limb circumference (LC) = LC >20 mm; “Grade 3” LC = LC >40 mm|Within 4 days (Day 0-3) after fourth dose vaccination|The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase||Subjects|||Number
169904|NCT00129129|Secondary|Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||IU/mL||95% Confidence Interval|Geometric Mean
169905|NCT00129129|Secondary|Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)||Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
171391|NCT00114972|Secondary|The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)||5 Years||||||
169906|NCT00129129|Secondary|Anti-PSY Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
169907|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169908|NCT00129129|Secondary|Anti-PSC Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
169909|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169910|NCT00129129|Secondary|hSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
169911|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169912|NCT00129129|Secondary|hSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
169913|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169914|NCT00129129|Secondary|rSBA-MenY Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
169915|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169916|NCT00129129|Secondary|rSBA-MenC Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Titers||95% Confidence Interval|Geometric Mean
170002|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||µg/mL||95% Confidence Interval|Geometric Mean
169917|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values|rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169918|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
169919|NCT00129129|Secondary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.|Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169920|NCT00129129|Secondary|Concentration of Antibodies Against Streptococcus Pneumonia Serotypes|"Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||µg/mL||95% Confidence Interval|Geometric Mean
169921|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169922|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169923|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)|"Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine.~Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F."|One month after fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169924|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2):~Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8),~At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8,~At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169925|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)|"Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1):~Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16),~Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
171392|NCT00114972|Secondary|Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation||1 year, 3 and 5 years post allocation||||||
169926|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2):~Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8),~At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128,~At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169927|NCT00129129|Secondary|Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)|"Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1):~Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32),~Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose."|One month post fourth dose vaccination (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.||Subjects|||Number
169928|NCT00129129|Secondary|Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians’ Office, Related or Not to Common Illnesses|Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169929|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169930|NCT00129129|Secondary|Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169931|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169932|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169933|NCT00129129|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169934|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. “Any” = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; “Grade 3” for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; “Grade 3” Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); “Grade 2 or 3” fever = rectal temperature higher than (>) 39°C; “Grade 3” fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
170064|NCT00128492|Primary|Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||mg/dL||Standard Deviation|Mean
169935|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms|Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. “Any” = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. “Grade 2” for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; “Grade 3” for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; “Grade 3” Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); “Grade 2 or 3” fever = rectal temperature higher than (>) 39°C; “Grade 3” fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169936|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling at injection site. “Any” = any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 8 days (Day 0-7) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169937|NCT00129129|Secondary|Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms|Solicited local symptoms were pain, redness and swelling at injection site. “Any” = any report of the specified symptom irrespective of intensity grade; “Grade 2 pain” = cried/protested on touch; “Grade 3 pain” = cried when limb was moved/spontaneously painful; “Grade 2 or 3” redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); “Grade 3” redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Within 4 days (Day 0-3) after the 3-dose primary vaccination|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169938|NCT00129129|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169939|NCT00129129|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Titers||95% Confidence Interval|Geometric Mean
169940|NCT00129129|Secondary|Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169941|NCT00129129|Secondary|Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to the primary vaccination course (at Day 0)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||EL.U/mL||95% Confidence Interval|Geometric Mean
169942|NCT00129129|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169943|NCT00129129|Secondary|Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||mIU/mL||95% Confidence Interval|Geometric Mean
170065|NCT00128492|Primary|Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||U/L||Standard Deviation|Mean
169944|NCT00129129|Secondary|Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)|This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169945|NCT00129129|Secondary|Anti-diphtheria and Anti-tetanus Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||IU/mL||95% Confidence Interval|Geometric Mean
169946|NCT00129129|Secondary|Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)|The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169947|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169948|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169949|NCT00129129|Secondary|Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off|The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169950|NCT00129129|Secondary|Anti-PRP Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
169951|NCT00129129|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values|Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|Prior to and one month after the primary vaccination course (at Day 0 and Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169952|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .|One month after the fourth dose (at Month 11-14)|The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose.||Subjects|||Number
169953|NCT00129129|Primary|Number of Subjects Reporting Any Grade 3 Symptoms|“Symptoms” were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A “Grade 3” symptom was defined as any symptom that prevented normal everyday activity. “Any” was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|During the 4-day follow-up period after each primary vaccine dose|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169954|NCT00129129|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||EL.U/mL||95% Confidence Interval|Geometric Mean
169955|NCT00129129|Primary|Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
169956|NCT00129129|Primary|Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.|The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .|One month after the 3-dose primary vaccination course (at Month 5)|The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase||Subjects|||Number
169957|NCT00129129|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169958|NCT00129129|Secondary|Number of Subjects Reporting Rash|An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169959|NCT00129129|Secondary|Number of Subjects Reporting Medically Attended Visits|A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.|During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0|The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.||Subjects|||Number
169960|NCT00129129|Secondary|Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
169961|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values|Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169962|NCT00129129|Secondary|Anti-polysaccharide C (Anti-PSC) Antibody Concentrations|Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||µg/mL||95% Confidence Interval|Geometric Mean
169963|NCT00129129|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values|Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
170066|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||g/dL||Standard Deviation|Mean
169964|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169965|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4|A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.|One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169966|NCT00129129|Secondary|Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Titers||95% Confidence Interval|Geometric Mean
169967|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values|rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169968|NCT00129129|Secondary|Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers|Titers are presented as geometric mean titers (GMTs).|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Titers||95% Confidence Interval|Geometric Mean
169969|NCT00129129|Secondary|Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values|rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.|Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)|The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.||Subjects|||Number
169970|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the booster phase (up to study Month 1 – booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
169971|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
169972|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
169973|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the booster phase)|The Booster Total Vaccinated Cohort included all subjects who received the booster dose.||Subjects|||Number
169974|NCT00129116|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Over the full course of the primary phase (up to study Month 3 – primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
169975|NCT00129116|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
169976|NCT00129116|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
169977|NCT00129116|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 8-day (Day 0-7) follow-up period (during the primary phase)|The Total Vaccinated Cohort included all subjects with study vaccine administered for whom data were available.||Subjects|||Number
169978|NCT00129116|Secondary|Number of Subjects With Vaccine Response to PT, FHA and PRN|Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
169979|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
169980|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-hepatitis B Antibodies|Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
169981|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-diphtheria Antibodies|Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
169982|NCT00129116|Secondary|Anti-poliovirus Types 1, 2, 3 Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Titers||95% Confidence Interval|Geometric Mean
169983|NCT00129116|Secondary|Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||mIU/mL||95% Confidence Interval|Geometric Mean
169984|NCT00129116|Secondary|Anti-diphtheria Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.|One month after the third dose (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||IU/mL||95% Confidence Interval|Geometric Mean
169985|NCT00129116|Secondary|Anti-T Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||IU/mL||95% Confidence Interval|Geometric Mean
169986|NCT00129116|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).|Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
169987|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
169988|NCT00129116|Secondary|Anti-PSC Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
170067|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Hemoglobin (MCH)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||pg||Standard Deviation|Mean
169989|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
169990|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
169991|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Titres||95% Confidence Interval|Geometric Mean
169992|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Titers||95% Confidence Interval|Geometric Mean
169993|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128|rSBA-MenY antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
169994|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128|rSBA-MenC antibody titre cut-off value assessed was ≥1:128|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
169995|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||µg/mL||95% Confidence Interval|Geometric Mean
169996|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to and one month post booster vaccination (at study Months 0 and 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
169997|NCT00129116|Secondary|Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)|Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
169998|NCT00129116|Secondary|Number of Seroprotected Subjects for Anti-tetanus Antibodies|Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
169999|NCT00129116|Secondary|Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||EL.U/mL||95% Confidence Interval|Least Squares Mean
170000|NCT00129116|Secondary|Anti-tetanus Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||IU/mL||95% Confidence Interval|Geometric Mean
170001|NCT00129116|Secondary|Anti-PSY Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||µg/mL||95% Confidence Interval|Geometric Mean
170068|NCT00128492|Primary|Serum Hematology - Mean Corpuscular Volume (MCV)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||fL||Standard Deviation|Mean
171393|NCT00114972|Secondary|Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation||1 month after procedure and 6 months, 1, 3 and 5 years post allocation||||||
170003|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170004|NCT00129116|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)|Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170005|NCT00129116|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||µg/mL||95% Confidence Interval|Geometric Mean
170006|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170007|NCT00129116|Secondary|rSBA-MenY Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Titers||95% Confidence Interval|Geometric Mean
170008|NCT00129116|Secondary|rSBA-MenC Antibody Titres|Titres are expressed as geometric mean titres (GMTs)|Prior to the first dose and one month after the third dose (at study Months 0 and 3 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Titers||95% Confidence Interval|Geometric Mean
170009|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
170010|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
170011|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Prior to the booster vaccination (at study Month 0 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
170012|NCT00129116|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170013|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170014|NCT00129116|Secondary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|Before the administration of the first dose (at pre-vaccination = study Month 0 – primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170015|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
170069|NCT00128492|Primary|Serum Hematology - Hemoglobin||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||g/dL||Standard Deviation|Mean
171394|NCT00114972|Secondary|Freedom From MACCE and Its Components at 5 Years Post-allocation||5 years post allocation||||||
170016|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
170017|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after the booster vaccination (at study Month 1 – booster phase)|The Booster According-To-Protocol cohort for immunogenicity included all vaccinated subjects who complied with the procedures defined in the protocol and for whom immunogenicity data were available.||Subjects|||Number
170018|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8|rSBA-MenY antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170019|NCT00129116|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8|rSBA-MenC antibody titre cut-off value assessed was ≥1:8|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170020|NCT00129116|Primary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).|Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)|One month after dose 3 (at study Month 3 - primary phase)|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample.||Subjects|||Number
170021|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.|Phosphate: any Phosphate increase would refer to a positive response.|6 months|||participants|||Number
170022|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium|Magnesium: Any Magnesium increase would refer to a positive response.|6 months|||participants|||Number
170023|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase|Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response|6 months|||participants|||Number
170024|NCT00128921|Secondary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin|Osteocalcin: Any Osteocalcin increase means positive response.|6 months|||participants|||Number
170025|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium|Calcium: any Calcium increase would refer to a positive response.|6 months|||participants|||Number
170026|NCT00128921|Primary|Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone|Parathyroid hormone: Any increase in PTH was considered response|6 months|||participants|||Number
170027|NCT00128830|Primary|Number of Participants With Adverse Events|Number of participants who reported at least 1 of the adverse events.|Up to 3 years|Intent-to-treat population: Participants who received at least 1 dose of study medication were included||Participants|||Number
170028|NCT00128830|Secondary|Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)|Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant).|Baseline and Endpoint (ie, the last available time point during the treatment period)|Intent-to-treat population: Participants who received at least 1 dose of study medication were included||Participants|||Number
170029|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192||x 1000000 cells/mL||Full Range|Median
170030|NCT00128830|Secondary|Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||x 1000000 cells/mL||Full Range|Median
170031|NCT00128830|Secondary|Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||x 1000000 cells/L||Full Range|Median
170032|NCT00128830|Secondary|Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48|The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48||x 100000 cells/L||Full Range|Median
170070|NCT00128492|Primary|Serum Hematology - Hematocrit||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||percent||Standard Deviation|Mean
171395|NCT00114972|Primary|Repeat Revascularization (PCI and/or CABG).|Number of participants with repeat revascularization (PCI and/or CABG).|12 Months post enrollment|||Participants|||Number
170033|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 192|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192||Participants|||Number
170034|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96|Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||Participants|||Number
170035|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 96|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96||Participants|||Number
170036|NCT00128830|Secondary|Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48|Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.|Week 48|Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48||Participants|||Number
170037|NCT00128713|Secondary|Highest Grade of Bleeding While on Study|Highest grade of bleeding during time on study using Platelet Dose Trial modification of World Health Organization Bleeding Scale. Grades 0-1 (no or minimal bleeding), 2 (moderate bleeding), 3 (bleeding generally requiring red cell transfusion), 4 (severe bleeding)|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|The analysis was done as intention to treat. Subjects for which highest grade of bleeding could not be determined (non-evaluable) were excluded.||participants|||Number
170038|NCT00128713|Secondary|Bleeding Severity, if a Suitable Scale is Validated and Published by the Time the Trial Ends|No suitable scale was identified, so no analyses for this outcome were carried out|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Analysis not performed; no applicable bleeding severity scale validated and published by end of PLADO Study|||||
170039|NCT00128713|Secondary|Number of Platelet Transfusion Episodes|Number of platelet transfusion episodes among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.||Number of platelet transfusion episodes||Full Range|Median
170040|NCT00128713|Secondary|Platelet Utilization|Total number of platelets transfused, based on attempted dose, among subjects who have at least one platelet transfusion and no missing data on attempted doses.|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|Subjects with missing information and those that did not receive at least one platelet transfusion were excluded from the analysis.||Number of platelets (x10^11)||Full Range|Median
170041|NCT00128713|Primary|At Least One Day With Grade 2 or Higher Bleeding|Any Grade 2 (moderate) or higher grade bleeding, as determined by daily hemostatic assessment and documentation of any red blood cell transfusions to treat bleeding|From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first)|These analyses were done on an intention-to-treat basis. That is, patients were counted in the treatment arm to which they were randomly assigned, even if they actually received transfusions that were not according to their assigned dosing strategy.||participants|||Number
170042|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 30 days (Days 0-29) after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
170043|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From the fourth year follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170044|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the third year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170045|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the second year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170046|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|During the first year of follow-up period|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170047|NCT00128661|Secondary|Number of Subjects With All Possible Pregnancy Outcomes|The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.|During the entire study period (From Month 0 up to Month 48).|The analysis was performed on the Total Vaccinated Cohort, on all pregnant subjects.||subjects|||Number
170048|NCT00128661|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
170049|NCT00128661|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (From Month 0 up to Month 48).|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
170050|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
170051|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|From Day 3 to Day 6 after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
170052|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature > 39.0°C.|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
170053|NCT00128661|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|Within 60 minutes after vaccination|The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.||Subjects|||Number
170054|NCT00128661|Secondary|HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).~Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination.~Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination.~Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
170071|NCT00128492|Primary|Serum Hematology - Number of Red Blood Cells (RBC)||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||number x10^6/µL||Standard Deviation|Mean
171396|NCT00114972|Secondary|Freedom From MACCE and Its Components at 3 Years Post-allocation||3 years post allocation||||||
170055|NCT00128661|Secondary|HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs).~Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination.~Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination.~Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
170056|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).~Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination.~Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination.~Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)."|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
170057|NCT00128661|Secondary|Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.|"Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs).~Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination.~Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination.~Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)"|Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48|The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.||Titers||95% Confidence Interval|Geometric Mean
170058|NCT00128661|Secondary|Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases|"Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type.~Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months.~Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type."|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170059|NCT00128661|Secondary|Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type|"Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen.~Note: The assay did not distinguish between HPV types 68 and 73.~CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer~Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type"|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170060|NCT00128661|Secondary|Number of Cervical Infection With HPV16 or HPV18.|Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170061|NCT00128661|Primary|Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.|"CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer.~Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained.~Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type."|From Month 6 up to Month 48|The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).||Events|||Number
170062|NCT00128492|Primary|Serum Chemistry - Concentration of Total Protein||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||g/dL||Standard Deviation|Mean
170063|NCT00128492|Primary|Serum Chemistry - Concentration of Chloride, Potassium, and Sodium||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||mEq/L||Standard Deviation|Mean
170072|NCT00128492|Primary|Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils||Baseline and end of treatment Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||percent of differential||Standard Deviation|Mean
170073|NCT00128492|Primary|Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets||Baseline and end of Course 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI. Results obtained at the end of a 28-day treatment period are presented for selected timepoints.||number of cells x10^3/µL||Standard Deviation|Mean
170074|NCT00128492|Primary|Change in Respiratory Rate (RR)|"RR was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||breaths/minute||Standard Deviation|Mean
170075|NCT00128492|Primary|Change in Temperature|"Temperature was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||degrees Celsius||Standard Deviation|Mean
170076|NCT00128492|Secondary|Time to Intravenous (IV) Antipseudomonal Antibiotics|Use of IV antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. The time to first IV antipseudomonal antibiotic use was the number of days from baseline (Visit 1) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit) /or early withdrawal if censored.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Days||95% Confidence Interval|Median
170077|NCT00128492|Secondary|Missed School/Work Days Due to CF Symptoms|"Participants were provided with a diary card at each visit to record days of work and/or school missed due to their CF symptoms.~The percentage of school/work days missed was calculated as the total number of school/work days missed divided by the total number of on-study days multiplied by 100 across all participants in a treatment group."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Percentage of days missed||Standard Deviation|Mean
170078|NCT00128492|Secondary|Change in Body Weight|Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Percent change from baseline||Standard Error|Mean
170079|NCT00128492|Secondary|Time to First Hospitalization Due to a Respiratory Event|"Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) electronic case report form (eCRF).~Time to first hospitalization was the number of days from baseline (Visit 1) to the date of first hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Days||Full Range|Median
170080|NCT00128492|Secondary|Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS)|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). The minimal clinically important difference (MCID) corresponds to the smallest change in symptoms that a patient can detect and is a change in score of 4 points.|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Units on a scale||Standard Deviation|Mean
170081|NCT00128492|Secondary|Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75)|"Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines.~FEV1 = the volume of air exhaled in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudson equation, based upon participant age, gender, and height. FVC = (forced vital capacity) the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC.~The percent change from baseline is presented for each endpoint."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Percent change from baseline||Standard Deviation|Mean
170082|NCT00128492|Secondary|Minimum Inhibitory Concentration (MIC) of Aztreonam|"The aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||µg/mL|||Number
170083|NCT00128492|Secondary|Number of Participants With Other Pathogens|"Sputum samples were collected at all study visits for qualitative and quantitative culture for Burkholderia cepacia complex (BCC), Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus (including methicillin-sensitive [MSSA] and methicillin-resistant [MRSA] S.aureus), and fungal organisms.~Number of participants with other pathogens at baseline and end of AZLI treatment Courses 1, 3, and 9 are reported."|Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Participants|||Number
170548|NCT00123630|Primary|Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups||16 weeks|The analysis was per protocol. There were no subjects who were withdrawn or lost to follow-up in this study.||perecentage of eos per high power field|||Number
170084|NCT00128492|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum|"Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype).~Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero."|Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Log10 PA CFUs/g||Standard Deviation|Mean
170085|NCT00128492|Primary|Change in Systolic and Diastolic Blood Pressure (BP)|"BP was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||mm Hg||Standard Deviation|Mean
170086|NCT00128492|Primary|Change in Heart Rate (HR)|"HR was recorded at all visits.~Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined."|Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||beats/minute||Standard Deviation|Mean
170087|NCT00128492|Primary|Number of Subjects With <15% or ≥15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI|Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of ≥15% at any visit in which they received AZLI.|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||Participants|||Number
170088|NCT00128492|Primary|Number of Participants Reporting Adverse Events (AEs)|"Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death.~Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period."|Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug|The analysis population consisted of all enrolled participants who received one or more doses of AZLI.||participants|||Number
170089|NCT00128401|Secondary|Liebowitz Social Anxiety Scale (LSAS)|"Social anxiety symptoms were assessed using the Liebowitz Social Anxiety Scale (LSAS). It is a 24-item self-report instrument that measures overall social anxiety fear and avoidance symptoms. This is the baseline assessment. The 24 items are each rated twice, from a 0 to 3 scale, with 0 indicated no level of symptom and 3 indicating a high level of the system. One rating is for anxiety, and the other is for avoidance. Thus, the lowest possible score is 0, and the highest possible score is 144. The total score represents the simple sum of all 48 ratings."|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo||units on a scale||Standard Deviation|Mean
170090|NCT00128401|Primary|Clinical Global Improvement (CGI-S) Scale|Symptom severity and improvement was assessed using the Clinical Global Impressions scale (CGI). It is a 2-item clinician-administered instrument that measures the patients' illness severity and global improvement. The minimum value for the CGI is 1=Normal, not at all ill and the maximum value is 7=Among the most extremely ill patients.|12 weeks post baseline|The analyses included only those subjects who were assigned to the DCS condition and placebo||units on a scale||Standard Deviation|Mean
170091|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 18|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 18. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170092|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 16|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 16. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170093|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 14|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 14. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170154|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170094|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 12|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 12. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170095|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 10|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 10. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170096|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 8|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 8. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170097|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 6|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 6. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170098|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 4|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 4. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170099|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 2|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 2. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170100|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 1|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 1. Density at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170101|NCT00128219|Secondary|The Density of Type III GBS Cultured From Vaginal Swabs at Month 0|The density of type III GBS is an ordinal response with six Density Levels: negative (lowest density, Score 0); broth only (Score 1); 1+ (Score 2); 2+ (Score 3); 3+ (Score 4); and 4+ (highest density, Score 5). The number of swabs with each score was tabulated from swabs collected at Month 0 prior to vaccination.|Month 0|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Swabs|||Number
170102|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Persistently Type III GBS Culture Positive for Three or More Consecutive Visits|Number of vaginal GBS III culture positive for 3+ consecutive visits was calculated from the post-vaccination visits over the 18 month follow-up. Status at missed visits prior to loss to follow-up/final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
170103|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Were Type III GBS Culture Positive.|Number of participants whose vaginal swabs were type III GBS culture positive was calculated using data from the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up/final visit was imputed from the previous visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
170104|NCT00128219|Secondary|Number of Participants Whose Vaginal Cultures Are Type III GBS Culture Negative Throughout the Study.|Number of participants who were vaginal type III GBS negative was calculated throughout the the eighteen month post-vaccination follow-up period. Status at missed visits prior to loss to follow-up /final visit was imputed from the subsequent visit.|Every 2 months from time of vaccination up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
170105|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 18 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 18|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170106|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 16 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 16|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170107|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 14 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 14|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170108|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 12 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 12|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170109|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 10 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 10|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170110|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 8 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 8|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170111|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 6 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 6|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170112|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 4 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 4|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170113|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 2 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 2|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170114|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 1 Post Vaccination|Blood samples were collected from participants at each scheduled clinic visit and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 1|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
174120|NCT00093756|Secondary|Confirmed Tumor Response, Defined as a Complete or Partial Response Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart||Up to 5 years||||||
170115|NCT00128219|Secondary|Number of Participants With a Serum IgG Antibody to Type III GBS Post-Vaccination of 5 µg/mL or Greater at Month 0|Blood samples were collected from participants at each scheduled clinic visit beginning with Month 0 prior to vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The threshold for being considered seropositive was 5 µg/mL.|Month 0 prior to vaccination|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170116|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 18 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 18 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 18 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170117|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 16 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 16 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 16 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170118|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 14 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 14 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 14 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170119|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 12 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 12 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 12 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170120|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 10 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 10 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 10 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170121|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 8 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 8 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 8 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170122|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 6 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 6 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 6 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170123|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 4 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 4 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 4 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170124|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 2 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 2 months post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 2 months following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170125|NCT00128219|Secondary|Number of Participants With a Four-Fold or Greater Rise in Serum IgG Antibody to Type III GBS at Month 1 Post-Vaccination|Blood samples were collected from participants prior to vaccination and at 1 month post vaccination, and serum was assayed with an ELISA to measure IgG antibody levels to Type III GBS. The lower detection limit for the assay was 0.08 micrograms/milliliter (µg/mL), and antibody levels below this limit were recorded as 0.04 µg/mL by the laboratory. Fold rises compare IgG antibody levels at the post-vaccination visit to that obtained just prior to vaccination. Participants are considered a responder if the antibody increase was four-fold or greater.|Prior to and 1 month following vaccination|All enrolled participants with blood collected at both time points were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||participants|||Number
170126|NCT00128219|Secondary|Mean Fold-Rise in Serum IgG Antibody Levels to Type III GBS Post-Vaccination|Fold-rises compare the IgG antibody level at post-vaccination to that obtained just prior to vaccination, for each visit during the 18-month follow-up period. Assay results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Ratio||95% Confidence Interval|Mean
170127|NCT00128219|Secondary|Number of Participants With Any Solicited Local and Systemic Symptoms.|Participants maintained a diary card to report the occurrence of solicited local and systemic symptoms for 7 days after vaccination. Participants are counted if they indicated experiencing the symptom at any severity during the reporting period.|Safety surveillance during the 1st 7 days.|The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment. Due to vaccination errors, the number of participants in the Td group for the Safety Analysis Cohort (n=337) exceeds the number randomized to this group (n=334).||Participants|||Number
170128|NCT00128219|Secondary|Geometric Mean Concentration (GMC) of Serum Immunoglobulin G (IgG) Antibody Levels to Type III GBS Post-Vaccination.|The GMC was calculated from IgG antibody to type III GBS assay results on serum specimens obtained at clinic visits during the 18 month post-vaccination follow-up period. Results at missed visits prior to loss to follow-up/final visit were not imputed.|Prior to and at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 18 months following vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the ITT Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||µg/ml||95% Confidence Interval|Geometric Mean
170129|NCT00128219|Primary|The Time to First Vaginal Swab That is Type III GBS Culture Positive, With All Previous Cultures Negative for Type III GBS, Not Just the Immediately Preceding Culture.|Time to first acquisition of vaginal type III GBS was calculated as time from vaccination to the mid-point of the interval of ascertainment, censored by either the end of the follow-up period, or the first of 2 or more consecutive missed visits. Vaginal type III GBS status at missed visits prior to censoring was imputed from the subsequent visit.|Time from vaccination to acquisition of vaginal type III GBS, up to 18 months post-vaccination.|All enrolled participants with at least one post-enrollment efficacy assessment were included in the intention to treat (ITT) Efficacy Analysis Cohort. Women were included without regard to protocol adherence, and classified by treatment randomized rather than received.||Participants|||Number
170130|NCT00128206|Secondary|Cost Effectiveness||course of treatment||||||
170131|NCT00128206|Secondary|Completion of Therapy||course of treatment||||||
170132|NCT00128206|Primary|Number of Participants With Laboratory Test or Clinical Judgment Resulting in the Need to Stop Study Medication|Liver function tests were taken at regular intervals and clinical symptoms were reviewed at regular intervals in both study groups. On the basis of these tests and examinations, physicians determined whether the study drug needed to be stopped.|up to one year|The number of participants was determined by power calculations using estimates of toxicity from the literature. The analysis was intention to treat.||participants|||Number
170155|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
173119|NCT00100802|Primary|One Year Overall Survival|Estimated one year survival using the Kaplan-Meier methodology.|One year|Population is based on 106 eligible patients out of 118 patients enrolled.||Estimated probability||95% Confidence Interval|Number
170133|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen PPD|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1 and C1b who received the antigen are included in the analysis population.||Participants|||Number
170134|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
170135|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
170136|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
170137|NCT00128193|Primary|Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram|Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.|Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
170138|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Groups C1 and C1b who received the antigen are included in the analysis population.||Participants|||Number
170139|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
170140|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
170141|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All participants in Group C1 who received the antigen are included in the analysis population.||Participants|||Number
170142|NCT00128193|Primary|Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram.|Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.|Day 0 for QuantiFERON; Days 3, 7, and 28 for induration|All evaluable participants in Group C1b who received the antigen are included in the analysis population.||Participants|||Number
170143|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 28|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170144|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1, B2, C1 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170145|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170146|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Groups A1 and A2 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170147|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170148|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170149|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 2|The analysis population is restricted to participants in Group A2 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170150|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B2 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170151|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A2, B2 and C1b who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170152|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 7|The analysis population is restricted to participants in Groups B1 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170153|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants in Groups A1, B1 and C1 who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170156|NCT00128193|Primary|Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).|Day 3|The analysis population is restricted to participants who had measurable induration at the time of assessment.||Millimeters||Standard Deviation|Mean
170157|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170158|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170159|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170160|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170161|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170162|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170163|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170164|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170165|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 7|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170166|NCT00128193|Primary|Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms|If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.|Day 3|The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.||Millimeters||Standard Deviation|Mean
170167|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
170168|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
170169|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
170170|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
170171|NCT00128193|Primary|Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|||Participants|||Number
170172|NCT00128193|Primary|Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
170173|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
170174|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
170175|NCT00128193|Primary|Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.|Up to 28 Days|All participants in Groups B and C who received the antigen are included in the analysis population.||Participants|||Number
170176|NCT00128193|Primary|Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram|Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable erythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.|Up to 28 Days|All participants who received the antigen are included in the analysis population.||Participants|||Number
170177|NCT00128180|Secondary|Development of Serum Creatinine Greater Than or Equal to 3.0 mg/dL After Study Entry||6 months|Per protocol, this efficay analysis was limited to participants with confirmed hantavirus infection who did not have a serum creatinine equal or greater to 3.0 mg/dL at entry.||participants|||Number
170178|NCT00128180|Secondary|Length of Time on a Ventilator||6 months|Per protocol this efficacy analysis was limited to participants with confirmed hantavirus infection who were intubated and on a ventillator.||days||Standard Deviation|Mean
170179|NCT00128180|Secondary|Number of Participants Who Developed Refractory Shock Despite Fluid Resuscitation After Study Entry|Refractory shock refers to shock that persists despite fluid resucitation. Fluid resusitation refers to administration of intravenous fluids to maintain blood pressure and cardiac output.|6 months|Per protocol, this efficacy analysis was limited to participants with confirmed hantavirus infection who were not already in shock at study entry.||participants|||Number
170180|NCT00128180|Secondary|Number of Participants Intubated and Placed on a Ventilator After Study Entry.|Participants|6 months|This efficacy this analysis was limited to participants with confirmed hantavirus infection who were not already intubated at study entry.||participants|||Number
170181|NCT00128180|Secondary|Duration of Shock and/or Pressor/Inotropic Support|Pressor/inotropic support refers to the use of adrenaline-like medications to maintain blood pressure and cardiac output.|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.||days||Standard Deviation|Mean
170182|NCT00128180|Secondary|Duration of Hospital Stay in Days|Days|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantairus infection.||days||Standard Deviation|Mean
170183|NCT00128180|Secondary|Duration of ICU Stays||6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection, and this analysis was limited to those who were admitted to ICU. Four subjects with confirmed hantavirus infection were not admitted to ICU.||days||Standard Deviation|Mean
170184|NCT00128180|Secondary|Number of Participants on Extracorporeal Membrane Oxygenation (ECMO)|number of participants|6 months|Per protocol, efficacy analysis was limited to participants with confirmed hantavirus infection.||participants|||Number
170185|NCT00128180|Primary|Number of Participants With SAEs|The Number of participants with SAEs|6 months|Per protocol, safety analysis inluded all participants, including those where hantavirus infection was not confirmed.||participants|||Number
170186|NCT00128180|Primary|The Proportion of Subjects Who Develop Death, PaO2/FiO2 Ratio Less Than or Equal to 55, Cardiac Index Less Than or Equal to 2.2, Pulseless Electrical Activity, Ventricular Tachycardia or Fibrillation||28 days|Per protocol, the efficacy analysis was limited to participants with confirmed hantavirus infection.||proportion of paticipants|||Number
170187|NCT00127933|Secondary|Participants With Overall Survival|Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.|22 - 1191 days|The analysis was done on the post-operative Response Evaluable Population.||participants|||Number
170188|NCT00127933|Secondary|Participants With Disease-Free Survival|Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.|30 - 1102 days|The analysis was done on the Postoperative Response Evaluable Population.||participants|||Number
170189|NCT00127933|Secondary|Percentage of Participants With Local Recurrence|Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.|30 - 1102 days|Postoperative Response Evaluable Population||percentage of participants||95% Confidence Interval|Number
170190|NCT00127933|Secondary|Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))|The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.|post 2 and 4, 3-week cycles of treatment|Evaluable Population||percentage of participants||95% Confidence Interval|Number
170191|NCT00127933|Secondary|Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population||percentage of participants||95% Confidence Interval|Number
170192|NCT00127933|Primary|Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery|Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.|at the time of definitive surgery; after four 3-week cycles (3-4 months)|Pathological Response Evaluable Population||percentage of participants||95% Confidence Interval|Number
170193|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month following administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the Booster Total Vaccinated Cohort.||Subjects|||Number
170194|NCT00127855|Secondary|Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course|Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to one month after the 3-dose primary vaccination course (Month 5)|The analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
170195|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort.||Subjects|||Number
170196|NCT00127855|Secondary|Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course|Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort.||Subjects|||Number
170197|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose|The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.||Subjects|||Number
170198|NCT00127855|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).|During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course|The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.||Subjects|||Number
170199|NCT00127855|Secondary|Anti-pneumococcal Antibody Concentrations|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
170200|NCT00127855|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values|Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170201|NCT00127855|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||Titer||95% Confidence Interval|Geometric Mean
170202|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies|Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170203|NCT00127855|Secondary|Anti- HBs Antibody Concentrations|Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||Milli-International Units per Milliliter||95% Confidence Interval|Geometric Mean
170204|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies|Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170205|NCT00127855|Secondary|Anti- PT Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
170206|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies|Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170207|NCT00127855|Secondary|Anti-PRN Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
170208|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies|Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170209|NCT00127855|Secondary|Anti- FHA Antibody Concentrations|Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.||ELISA Units per Milliliter (EL.U/mL)||95% Confidence Interval|Geometric Mean
173197|NCT00099359|Primary|Infant HIV Infection Status|Intrapartum HIV infection at 3 Months|3 months|All infants with HIV-1 test results except infants infected at birth (i.e. in utero infections) were included in these analysis.||participants|||Number
170210|NCT00127855|Secondary|Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies|Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170211|NCT00127855|Secondary|Anti-tetanus Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
170212|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-tetanus Antibodies|Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170213|NCT00127855|Secondary|Anti-diphtheria Antibody Concentrations|Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||International Units per Milliliter||95% Confidence Interval|Geometric Mean
170214|NCT00127855|Secondary|Number of Subjects Seroprotected for Anti-diphtheria Antibodies|Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.||Subjects|||Number
170215|NCT00127855|Secondary|Anti-PRP Antibody Concentration|Concentrations are presented as GMCs and expressed as µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
170216|NCT00127855|Secondary|Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values|The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
170217|NCT00127855|Secondary|Anti-polysaccharide Y (PSY) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
170218|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
170219|NCT00127855|Secondary|Anti-polysaccharide C (PSC) Antibody Concentration|Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||microgram per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
170220|NCT00127855|Secondary|Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)|The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
170221|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Titer||95% Confidence Interval|Geometric Mean
170222|NCT00127855|Secondary|Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
170223|NCT00127855|Secondary|Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers|Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Titer||95% Confidence Interval|Geometric Mean
170224|NCT00127855|Secondary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.||Subjects|||Number
170225|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.||Subjects|||Number
170226|NCT00127855|Primary|Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8|The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.||Subjects|||Number
170227|NCT00127855|Primary|Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter|The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).|One month after primary vaccination (Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.||Subjects|||Number
170228|NCT00127842|Secondary|Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24|Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||percentage of participants||95% Confidence Interval|Number
170229|NCT00127842|Secondary|Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)|The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||percentage of participants||95% Confidence Interval|Number
170255|NCT00127192|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.||mg/dL||95% Confidence Interval|Least Squares Mean
170230|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied. Change was based on paired data.||Percentage change||Full Range|Mean
170231|NCT00127842|Secondary|Change From Baseline to Month 24 in Patient Global Assessment|The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||Units on a scale||Standard Deviation|Mean
170232|NCT00127842|Secondary|Percent Change From Baseline to Month 24 in Physician Global Assessment|"The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites).~Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement."|Baseline and Month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||Percentage change||Full Range|Mean
170233|NCT00127842|Secondary|Change From Baseline to Month 24 in the Physician Global Assessment|The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.|Baseline and month 24|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||Units on a scale||Standard Deviation|Mean
170234|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module|"In the HLQ impediments to paid and unpaid labor module participants were asked Were you hindered by health problems at your paid work over the past two weeks? and answered according to the following: 'no not at all = 0', ‘yes, a little = 1’, ‘yes, very = 2’. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points.||Units on a scale||Standard Deviation|Mean
170235|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and month 24|"Full Analysis Set participants who completed the HLQ at Baseline and Month 24 and who performed any unpaid work at both time points (71 participants). n indicates the number of participants who had unpaid or paid help with their unpaid work."||Hours||Standard Deviation|Mean
170236|NCT00127842|Secondary|Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module|"The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks.~Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement."|Baseline and Month 24|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, were employed, and indicated they had some production losses due to health problems at work (participants with no production losses were not included).||Hours||Standard Deviation|Mean
170256|NCT00127192|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.||Percent||95% Confidence Interval|Least Squares Mean
174362|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question How satisfied are you with your progress?"|8 months|Number of participants who completed the 8 months satisfaction questions||participants|||Number
170237|NCT00127842|Secondary|Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module|The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.|Baseline and 24 months|Full Analysis Set participants who completed the HLQ at Baseline and Month 24, and were employed.||days||Standard Deviation|Mean
170238|NCT00127842|Primary|Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI|The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and 24 months|Full Analysis Set, composed of all participants who received at least one dose of study medication and had at least one baseline and at least one post-baseline measurement for the endpoint of interest. Imputation by last observation carried forward (LOCF) was applied.||percentage of participants||95% Confidence Interval|Number
170239|NCT00127803|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.||Day 0 to up to 70 days post-first vaccination|Safety assessments were on the safety population.||Participants|||Number
170240|NCT00127803|Primary|Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.||Day 0 and up to 7 days post each vaccination|Safety assessments were on the safety population.||Participants|||Number
170241|NCT00127803|Secondary|Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.|"Seroconversion was defined as a ≥4-fold increase in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used.~Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA)."|Days 28, 56, 70, and 236 Post First Vaccination|Serum anti-toxin levels were assessed in the Fully Evaluable (Per-Protocol) Population.||Participants|||Number
170242|NCT00127790|Secondary|Depression Severity|Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.|Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)|participants who completed intervention and pre and post treatment assessments||units on a scale||Standard Error|Mean
170243|NCT00127790|Primary|IL-6|Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|Subjects completing blood draws to obtain plasma. One subject in the CBT-I&P condition did not complete blood draws.||pg/mL||Standard Error|Mean
170244|NCT00127790|Primary|Pain Severity|Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|||units on a scale||Standard Error|Mean
170245|NCT00127790|Primary|Insomnia Severity|Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.|Pre to Post Treatment Change (Over an average of approximately 10 weeks)|completed the intervention and self report instruments||units on a scale||Standard Error|Mean
170246|NCT00127712|Secondary|Length of Hospital Stay||Duration of hospitalization|||Days||Full Range|Median
170247|NCT00127712|Primary|Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds||7 days|||Participants|||Number
170248|NCT00127712|Secondary|Length of Intensive Care Unit Stay||Duration of hospitalization|||Hours||Full Range|Median
170249|NCT00127712|Primary|Incidence of Atrial Fibrillation Requiring Treatment||7 days|||participants|||Number
170250|NCT00127530|Secondary|Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity||Days 14, 42, 70, 98||||||
170251|NCT00127530|Primary|Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)|Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.|Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.|ITT Population||Participants|||Number
170252|NCT00127413|Primary|Clinician Administered Assessment of PTSD|This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, & Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD.|Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up|||units on a scale||Standard Deviation|Mean
170253|NCT00127218|Secondary|Time to Multiple Combined Events ( Cardiovascular and Cerebrovascular Events, Myocardial Revascularization as Well as All Cause and Cardiovascular Death)||18 months||||||
170254|NCT00127218|Primary|Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries|The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.|18 months|||percentage of internal carotid artery||Standard Error|Mean
170257|NCT00127192|Secondary|Change From Baseline in Glycosylated Albumin at Week 12|Change from baseline at Week 12 is defined as Week 12 minus Week 0.|Baseline and Week 12|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. For FAS patients with no data at Week 12, the last non-baseline observed measurement was carried forward to Week 12.||Percent||95% Confidence Interval|Least Squares Mean
170258|NCT00127166|Secondary|Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent change from baseline||95% Confidence Interval|Least Squares Mean
170259|NCT00127166|Secondary|Time to Recovery to Within 5% of Baseline FEV1|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||minutes||Inter-Quartile Range|Median
170260|NCT00127166|Secondary|Maximum FEV1 % Predicted Following First Beta-agonist Use|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent of predicted value||95% Confidence Interval|Least Squares Mean
170261|NCT00127166|Secondary|Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))|The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent times Minutes||95% Confidence Interval|Least Squares Mean
170262|NCT00127166|Primary|Maximum Post-exercise Percent (%) Fall in FEV1|The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.|4 weeks (Weeks 0 to 4 or Weeks 6 to 10)|The primary efficacy analysis was based on the full analysis set (FAS) population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.||Percent change from baseline||95% Confidence Interval|Least Squares Mean
170263|NCT00127101|Secondary|Number of Participants Who Responded to Treatment|"Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score.~SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400"|Every 28 days for up to 6 Months of Treatment|All patients treated||Participants|||Number
170264|NCT00127101|Primary|Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities|Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1.|Day 1 to day 28|All Patients treated||Participants|||Number
170265|NCT00127036|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella’s method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%.|30 Days After End of Treatment - Average of 6 Months|All participants.||participants|||Number
170266|NCT00127036|Secondary|Number of Participants Per Treatment Arm, With Overall Survival (OS)|Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.|||||
170267|NCT00127036|Primary|Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier|Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).|30 Days After End of Treatment - Average of 6 Months|Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.|||||
170268|NCT00126776|Primary|Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)||1 yr|||events per year||95% Confidence Interval|Mean
170269|NCT00126776|Secondary|All Cause Mortality||1 year||||||
170270|NCT00126776|Secondary|COPD Exacerbations Requiring Antibiotics or Corticosteroids||1 year||||||
170271|NCT00126776|Secondary|Quality of Life||1 year||||||
170272|NCT00126776|Secondary|All Cause Hospitalizations||1 year||||||
170273|NCT00126776|Primary|Hospitalization or Emergency Department Visit for COPD||1 yr||||||
170274|NCT00126750|Primary|Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators|The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level < previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level < previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (<8%).|1/1/02 - 12/31/08|||percentage of provider's patients|||Number
170275|NCT00126737|Secondary|Stair Total (Climb, Descend)|Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.|Between Base-line and 24 Weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 1 in Weight Control Nutritional Program, 1 in Home-based exercise Program and 1 in Usual Care.||Change in Steps||95% Confidence Interval|Mean
170276|NCT00126737|Secondary|Walking Distance|Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 2 in Weight Control Nutritional Program.||Change in Distance (m)||95% Confidence Interval|Mean
170277|NCT00126737|Primary|Mental Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program and 3 in Usual Care||Change in Score||95% Confidence Interval|Mean
170278|NCT00126737|Primary|Physical Scale SF-36v|The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 3 in the Usual Care.||Change in score||95% Confidence Interval|Mean
170279|NCT00126737|Primary|WOMAC Function|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.|Between Base-line and 24 weeks|There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 1 in Home-based exercise program and 1 in Usual Care.||Change in Score||95% Confidence Interval|Mean
170280|NCT00126659|Secondary|Overall Survival|The number of participants surviving from baseline (treatment) to death due to any cause measured in days.|Up to 2 years||||||
170281|NCT00126659|Secondary|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), measured in days.|Following 10 weeks of treatment, followed every 2 weeks or until disease progression||||||
170282|NCT00126659|Secondary|Time to Progression|Time, in weeks, after treatment until disease progresses. Repeat radiologic studies to evaluate disease progression or response after 10 weeks of BAY 43 9006 therapy.|Following 10 weeks of treatment or until disease progression||||||
170283|NCT00126659|Primary|Efficacy of BAY 43-9006 by Evaluating Response Rate|"Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: Disappearance all target lesions; Partial Response (PR): > 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): > 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or > new lesions; Stable Disease:~Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started."|Every 2 weeks during 4 week cycle|Unable to assess response due to small sample size.|||||
170295|NCT00126581|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Duration of study (up to 3 years)|||participants|||Number
174369|NCT00090545|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|49 months|||participants|||Number
170284|NCT00126594|Post-Hoc|Best Overall Response for Participants|Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria as defined by RECIST: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|From the date response is confirmed to the date of disease progression, first assessed 2 months (8 weeks) following start of treatment and reassessed up to 36 months (on average reassessed 12 months or less).|All participants were included per intent to treat analysis.||participants|||Number
170285|NCT00126594|Secondary|Duration of Response for Participants With Stable Disease (N=37) Following Treatment|Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.|From the date response is confirmed to the date of disease progression, up to 12 months|"Combined analysis reflects overall stable disease duration e.g. duration of benefit for stable disease cases without being affected by the median duration not attainable for the separate arms; 37 participants in the two arms met Stable Disease criteria: 17 in Sorafenib alone (Arm I) and 20 in the Sorafenib Plus Interferon group (Arm II)."||Months||95% Confidence Interval|Median
170286|NCT00126594|Secondary|Median Overall Survival (OS)|Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.|From the start of protocol therapy to death or date of last follow-up, up to 36 months|Participants who die of unrelated cause during therapy or are lost to follow-up were censored. Median OS was not reached in Arm 1: Sorafenib as subjects experienced different events that made further follow-up impossible i.e. disease complications, death or lost to follow-up so overall survival data was not attainable.||Months||95% Confidence Interval|Median
170287|NCT00126594|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months|All participants were included per intent to treat analysis.||Months||95% Confidence Interval|Median
170288|NCT00126594|Secondary|Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.|Up to 12 months of treatment|All participants were included in adverse event reporting per intent to treat analysis.||participants|||Number
170289|NCT00126594|Primary|Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)|ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.|Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.|Analysis performed for the intent-to-treat population.||percentage of participants||95% Confidence Interval|Number
170290|NCT00126581|Other Pre-specified|Overall Response Rate With KRAS Mutational Status|Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms.|Duration of study (up to 3 years)|||percentage of participants||95% Confidence Interval|Number
170291|NCT00126581|Other Pre-specified|Progression Free Survival With KRAS Mutation Status|Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms.|Duration of study (up to 3 years)|||months||95% Confidence Interval|Median
170292|NCT00126581|Other Pre-specified|Overall Response Rate by EGFR Mutation Status|Response and EGFR mutation status are defined in previous outcome measures.|Duration of study (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.||percentage of participants|||Number
170293|NCT00126581|Other Pre-specified|Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status|"PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.~EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome."|Duration of treatment (up to 3 years)|EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.||months||95% Confidence Interval|Median
170294|NCT00126581|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 3 years)|||months||95% Confidence Interval|Median
170296|NCT00126581|Secondary|Overall Response Rate|"The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions"|Duration of Study (up to 3 years)|||percentage of participants||95% Confidence Interval|Number
170297|NCT00126581|Primary|18 Weeks Progression Free Survival (PFS) Rate|"The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm.~The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated."|At 18 weeks|||percentage of participants||95% Confidence Interval|Number
170298|NCT00126568|Secondary|To Further Characterize the Safety Profile of BAY 43-9006 When Given to Patients With Advanced Anaplastic Carcinoma of the Thyroid.|The safety and toxicity profile of BAY 43-9006 as measured by toxicity grades of adverse events.|weekly||||||
170299|NCT00126568|Secondary|Overall Survival Was Measured From the Date of Outset of Treatment to the Date of Death.||27 months|All patients on study.||months||95% Confidence Interval|Median
170300|NCT00126568|Secondary|Progression Free Survival Was Measured From the Date of Outset of Treatment to the Date of Disease Progression.||27 months|All patients on study||months||95% Confidence Interval|Median
170301|NCT00126568|Primary|Number of Patients With Response to Treatment Measured by RECIST Criteria|Response evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The patient's best response depends on the achievement of measurement and confirmation criteria of Complete Response (CR), Stable Disease (SD), Partial Response (PR) or Progressive Disease (PD). Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, x-ray) or as >10 mm with spiral CT scan.|at 6 months after treatment|All patients that received at least one cycle of treatment||participants|||Number
170302|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: UnExpected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.||participants|||Number
170303|NCT00126555|Post-Hoc|Participant Treatment Following Induction Therapy|Treatment received following two 30-day cycles (60 days) of 250 mg gefitinib given by mouth daily. Participant treatment reported as percentage of total treated participants out of total treated.|Following 60 days of Gefitinib induction treatment|||percentage of participants|||Number
170304|NCT00126555|Secondary|Change in Epidermal Growth Factor Receptor (EGFR) and Phospho-Akt Expression||From baseline to up to 30 days||||||
170305|NCT00126555|Secondary|Frequency and Timing of Local and Distant Failures||From study entry to first documented local recurrence or last patient contact, assessed up to 5 years||||||
170306|NCT00126555|Secondary|Clinical Response According to Response Evaluation Criteria In Solid Tumors (RECIST)|Number participants with response defined by RECIST: Complete Response (CR): Disappearance all disease; No new lesions/non-evaluable disease; Responders on none/only maintenance doses of corticosteroids. Partial Response (PR): >/= 50% decrease under baseline in sum products perpendicular diameters of measurable lesions; No progression evaluable disease/new lesions; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Stable/No Response (SD): Not qualify for CR, PR, or progression; requires minimum 12 weeks duration; Responders on same/decreasing doses dexamethasone & stable/improved neurological exams. Progression (PD): 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), OR clear worsening any evaluable disease, OR appearance any new lesion/site, OR failure to return due to death/deteriorating condition. All measurable/evaluable sites assessed using same baseline techniques.|Up to 5 years|One participant of 23 enrolled withdrew prior to treatment.||participants|||Number
170307|NCT00126555|Primary|Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Associated With Gefitinib Therapy: Expected Toxicities (Grade 1 - 3)|Severity and timing of toxicities evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3. Occurrences of late (post-radiation) toxicities that are radiation-related monitored and included.|Up to 5 years|Of 23 enrolled, 1 withdrew, 2 went off study during induction for adverse events and 3 had progressive disease. Of 17 continuing to clinical response assessment (11 on 250 mg/day Induction dose & 6 to 500 mg/day dose escalation), 12 were resectable (2 refused), 2 unresectable and 3 had disease progression leaving only 6 for maintenance.||participants|||Number
170308|NCT00126555|Primary|Feasibility Rate|Determined by the surgical healing time (resectable patients) and of concomitant gefitinib by treatment interruption during radiotherapy.|Up to 7 weeks||||||
170309|NCT00126555|Primary|Early Progression Rate|Number of participants out of total participants with progression following two 30 day courses of Gefitinib. Tumor response evaluated by Response Evaluation Criteria in Solid Tumors by physical exam, computed tomography (CT) or Magnetic Resonance Imaging (MRI). Progressive disease defined as determined as response to Gefitinib induction therapy: Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants restaged on days 15 and 60 of treatment.|Baseline to 60 days, up to 2 courses of induction therapy|||percentage of participants|||Number
174363|NCT00090584|Secondary|Satisfaction|"Number of women who responded completely satisfied to question, How satisfied are you with your progress?"|10 weeks|Number of women who completed satisfaction question at 10 weeks.||participants|||Number
170310|NCT00126503|Primary|Objective Response|Objective response as determined by RECIST v. 1.0 (measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions)or last date known alive|Every 8 weeks to date of progression|Patients available for measurement of response to treatment with regimen. 7 Phase I and 4 Phase II patients were not available for measurement of response, respectively: disease progression (5, 2), complicating disease (1, 0), death on-study (1, 0), toxicity (0, 1), and alternative treatment (0, 1). All were counted as clinical progression.||participants|||Number
170311|NCT00126503|Primary|Maximum Tolerated Dose of Bevacizumab in Combination With BAY 43-9006 (Sorafenib)(Phase I)|The highest dose in milligrams (mg) of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab||mg/kg|||Number
170312|NCT00126503|Secondary|Progression-free Survival|Duration of months of progression-free survival (PFS). Determined by months to progressive disease or to last date known alive without progressive disease.|on-study to date of progression or last date known alive without progression|All patients who underwent treatment. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.||months||Full Range|Median
170313|NCT00126503|Secondary|Overall Survival|Months from date on-study to expired or last date known alive|on-study to date of expired or last date known alive|All treated patients available for determination of overall survival. No patients in the Phase I cohort moved to the Phase II cohort. No Phase II patients were in the Phase I cohort.||months||Full Range|Median
170314|NCT00126503|Primary|Maximum Tolerated Dose (MTD) of BAY 43-9006 (Sorafenib)in Combination With Bevacizumab (Phase I)|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. Cohorts of 3-6 patients received escalating doses of sorafenib and bevacizumab until the maximum tolerated dose (MTD) was achieved. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity during the initial cycle of therapy. DLTs include absolute neutrophil count (ANC) < 500/mm3 for > 7 days, ANC < 1000/mm3 with fever > 101 degrees Fahrenheit, platelet count < 50,000 mm3, and non-hematologic toxicity Common Toxicity Criteria (CTC) >= Grade 3.|at 28 days|Patients enrolled to determine the safety of BAY 43-9006 (Sorafenib) in combination with Bevacizumab||mg|||Number
170315|NCT00126490|Secondary|Number of Participants With Possibly Related Serious Adverse Events (SAEs)|Number of Participants with Serious Adverse Events (SAEs) Possibly Related to Study Treatment. Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Up to 30 days after completion of treatment|All Participants who received at least one treatment||participants|||Number
170316|NCT00126490|Secondary|Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function|Dendritic cell (DC) phenotype or functionality. Pearson correlation coefficients of DC:ImC ratio with DC function were to be computed and tested for departure from zero. Those with major responses were to be compared to those without major responses with respect to baseline DC:ImC ratio, baseline DC functional assay, post-treatment DC:ImC ratio and post-treatment DC functional assay using pooled t tests.|At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment|This was not evaluable because there were not enough samples.|||||
170317|NCT00126490|Secondary|Number of Evaluable Participants With Progression Free Survival (PFS)|Progression Free Survival tabulation at 1 year and at 2 years. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 2 years|Evaluable participants||participants|||Number
170318|NCT00126490|Secondary|Number of Evaluable Participants With Overall Survival (OS) at 2 Years|Overall Survival tabulation at 2 years from start of treatment.|2 years from start of treatment|Evaluable participants||participants|||Number
170319|NCT00126490|Primary|Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year|Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|1 year|All Participants who received at least one treatment||participants|||Number
170320|NCT00126425|Primary|Relationship Between the Occurrence of Adverse Cardiac Event and 123I-mIBG Uptake on Planar Scintigraphy Categorized as High or Low Heart to Mediastinum (H/M) Ratio|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Assessments were done by 3 independent readers. H/M ratios were categorized as ‘Low’ and ‘High’ based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data collected relative to time to adverse cardiac events.|Approximately 24 months from the date of administration of 123I-mIBG|Primary efficacy population was 520 participants in HF group who received IMP and had a diagnostic (optimal or sub-optimal) 3 hour 50 minute planar image. Images from 2 HF participants were inadvertently not submitted and not presented to blinded readers. Here, N=efficacy population and n=number of participants assessed by specific readers.||number of adverse cardiac events|||Number
170321|NCT00126191|Secondary|Disease Free Survival|Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.|Until disease progression up to 120 months|One low-risk participant was lost to follow-up after 48 months of disease free survival.||Months||Full Range|Mean
170334|NCT00125619|Secondary|Short Physical Performance Battery|Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.|4 weeks|||units on a scale||Standard Deviation|Mean
170322|NCT00126191|Primary|Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt|"Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed.~Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable.~Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment."|3 years|||participants|||Number
170323|NCT00126126|Secondary|Six-minute Walk Test|The six-minute walk test (6MWT) is a measure of overall functional mobility, and cardiopulmonary and musculoskeletal endurance. It assesses the distance ambulated in 6 minutes. The 6MWT has excellent reliability for lower limb amputees and can differentiate between amputee Medicare Functional Classification Levels (MFCL).Lower limb amputees functioning at the K2 level ambulate a mean distance of 200 meters. Those at the K3 level ambulate a mean distance of 300 meters. Those at the K4 level ambulate a mean distance of 400 meters. Service Members with traumatic lower limb loss ambulate a distance of 600 meters. The minimal detectable change for the 6MWT is 45 meters.|8 weeks for intervention and wait list control group|Repeated Measures ANOVA||meters||Standard Deviation|Mean
170324|NCT00126126|Primary|Amputee Mobility Predictor|The Amputee Mobility Predictor is a reliable and valid performance-based outcome measure of prosthetic mobility. The AMP is scored from 0-47, higher scores indicating greater prosthetic mobility. The AMP can help clinicians differentiate between different functional K-levels based on as defined by the Medicare Functional Classification Level (MFCL) system. Lower limb amputees functioning at the K2 level score between 27-36 on the AMP and are classified as limited community ambulators. Those at the K3 level score between 37-42 and are typical community ambulators who have the ability to traverse environmental barriers and performing activities that are beyond simple locomotion. Individuals at the K4 level score between 43-47 which is typical of prosthetic demands of an active adult or regular athlete. The minimal detectable change for the AMP is 3.4 points.|8 weeks for intervention and for wait-list control|Repeated Measures ANOVA||Points||Standard Deviation|Mean
170325|NCT00126113|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome).|Day 70 (end of study)|||units on a scale||Standard Deviation|Mean
170326|NCT00126113|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ‘ Always ’ to ‘ Never ’ with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability).|Day 70 (end of study)|||units on a scale||Standard Deviation|Mean
170327|NCT00126113|Secondary|Hearing Handicap Inventory (HHI)|HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap).|Day 70 (end of study)|||units on a scale||Standard Deviation|Mean
170328|NCT00126113|Primary|Psychosocial Impact of Assistive Devices Scale (PIADS)|PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being.|Day 70 (end of study) only|||units on a scale||Standard Deviation|Mean
170329|NCT00125957|Primary|Hamilton Depression Rating Scale (HAM-D)|Median total depression ratings at baseline and follow-up using the HAM-D. The scale consists of 21 questions that assess depression symptoms. Questions 1-3, 7-11, 15, and 19 are rated on a scale of 0-4, with 0 being not present to and 4 being severe. Questions 4, 5, 12 - 14, 16-18 and 21 are rated from 0-2 with a score of 0 signifying the symptom is absent and a score of 2 as most severe. Item 20 is score on a scale of 0-3 with the same pattern of severity as all other questions. The total score for the HAM-D ranges from 0-63.|Baseline and follow-up|||units on a scale||Full Range|Median
170330|NCT00125957|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Median total depression symptoms rating at baseline and follow-up visits. The MADRS consists o 10 questions assessing depression symptoms. All questions are scored on a 0-6 severity scale, with 0 being absent and 4 being most severe. Total scores can range from 0-60.|Baseline and follow-up|||units on a scale||Full Range|Mean
170331|NCT00125931|Secondary|YMRS Scores|Assessment of current mania symptoms using YMRS. All questions have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean YMRS scores were reported, with the total ranging from 0-44. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|Each morning of the three-day study|||units on a scale||Standard Deviation|Mean
170332|NCT00125931|Primary|Mania Symptoms Using MACS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity.|hourly for 6 hours after first dose of pentazocine; hour 0 is the baseline score and also when first dose of pentazocine was administered|||units on a scale||Full Range|Mean
170333|NCT00125619|Secondary|Berg Balance Scale|Clinical measure of balance|4 weeks|||units on a scale||Standard Deviation|Mean
170335|NCT00125619|Secondary|Lower Extremity Fugl-Meyer Motor Assessment|Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.|4 weeks|||units on a scale||Standard Deviation|Mean
170336|NCT00125619|Secondary|Step Length Ratio (Abs)|measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]|4 weeks|||ratio||Standard Deviation|Mean
170337|NCT00125619|Secondary|Six Minute Walk|distance, in meters, walked overground over a six minute interval.|4 weeks|||meters||Standard Deviation|Mean
170338|NCT00125619|Secondary|Fast Walking Speed|Fastest comfortable walking speed measured while walking overground|4 weeks (s/p 12 training sessions)|||meters/s||Standard Deviation|Mean
170339|NCT00125619|Primary|Self-selected Overground Walking Speed|Overground walking speed determined as rate of walking over a 10 meter distance.|4 weeks (s/p 12 sessions of locomotor training)|||meters/s||Standard Deviation|Mean
170340|NCT00125593|Secondary|End-stage Renal Disease Among All Patients Not on Dialysis at the Time of Randomization to Simvastatin Plus Ezetimibe Versus Placebo|End-stage renal disease was defined as initiation of maintenance dialysis or renal transplantation. Temporary dialysis was excluded. All potential dialysis and transplant events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
170341|NCT00125593|Secondary|Coronary or Non-coronary Revascularization Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Revascularization included any arterial revascularization procedure, whether surgical or percutaneous, but excluded revascularization performed for hemodialysis vascular access (e.g. fistuloplasty) or to the donor kidney transplant artery. Revascularization included amputations for vascular disease (rather than for trauma or infection). All potential revascularization events (including angiography) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
170342|NCT00125593|Secondary|Non-hemorrhagic Stroke Among All of Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Stroke was defined as rapid onset of focal or global neurological deficit, with duration greater than 24 hours. Clinical notes and brain imaging were sought to determine the stroke etiology, and if the stroke was fatal and post-mortem examination findings were available, this information was also assessed. All potential stroke events (including transient ischemic attack and intracerebral hemorrhage) were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
170343|NCT00125593|Secondary|Major Coronary Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major coronary events defined as coronary death or non-fatal myocardial infarction. Myocardial infarction adjudicated based on the presence of serial changes in cardiac biomarkers (e.g. troponin, creatine kinase), typical ECG changes and typical cardiac symptoms. If myocardial infarction was fatal and post-mortem examination findings were available, this information was also assessed. All potential coronary events were adjudicated, using pre-specified objective criteria, by clinicians blinded to study treatment allocation and lipid levels. Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
170344|NCT00125593|Secondary|Major Vascular Events Analyzed Amongst Patients Initially Randomized to Simvastatin Plus Ezetimibe Versus Placebo (Original Protocol-defined Primary Outcome)|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|Includes only those patients initially randomized to simvastatin plus ezetimibe versus placebo (as opposed to all patients ever randomized to simvastatin plus ezetimibe versus all patients allocated placebo)||participants|||Number
170345|NCT00125593|Secondary|Major Vascular Events Analyzed Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major vascular events defined as non-fatal myocardial infarction or cardiac death, any stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
170346|NCT00125593|Primary|Key Outcome as Per Statistical Analysis Plan = Major Atherosclerotic Events Among All Patients Ever Randomized to Simvastatin Plus Ezetimibe Versus All Patients Allocated to Placebo|Major atherosclerotic events defined as non-fatal myocardial infarction or coronary death, non-hemorrhagic stroke, or any arterial revascularization procedure (excluding dialysis access procedures). Numbers provided = number of patients with events.|Median follow-up 4.9 years|||participants|||Number
170347|NCT00125528|Secondary|McGill Pain Questionnaire (MPQ)|Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.|6 weeks|||units on a scale||Standard Deviation|Mean
170348|NCT00125528|Primary|Change in Numeric Rating Scale (NRS-11)|Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.|6 weeks|||units on a scale||Standard Deviation|Mean
170349|NCT00125515|Primary|Retention in Treatment|The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.|Number of participants who complete 12 weeks of treatment|All analysis were conducted based on intent-to-treat principle.||participants|||Number
170350|NCT00125268|Secondary|Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment|The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.|baseline, 4 weeks||||||
170351|NCT00125268|Secondary|Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment|The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.|baseline, 4 weeks||||||
170352|NCT00125268|Primary|Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment|Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.|baseline, 4 weeks||||||
170353|NCT00125242|Primary|Word Retrieval Accuracy|"Accuracy of naming of pictured treated and untreated items was assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to follow-up (6 weeks following treatment). All naming responses were scored using a 0-10 scale reflecting promptness and presence of errors; scores of 8-10 received an accuate score and scores of 0-7 received an inaccurate score. A percentage accuracy score was calculated for each experimental set of items for every probe session. Baseline probe scores were compared to end of treatment and follow-up probe scores to obtain individual effect sizes for each experimental list of items for each participant (i.e., several effect sizes were calculated for each participant). All effect sizes were utlized to obtain an average effect size for each participant; these averages were then utlized to obtain a group average."|End of treatment and at 6 weeks post treatment|SFA Treatment Participants were stroke-survivors with chronic aphasia who had significant word retrieval difficulties. Non Treatment Stimuli Development Participants were only enrolled in the study to provide data for the development of treatment stimuli. As such, they were not assessed for the outcome measure.||d-index (effect size)|Participants|Standard Deviation|Mean
170354|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 34 - 86 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 86 were included in the analysis.||cm/yr||Standard Deviation|Mean
170355|NCT00125190|Post-Hoc|Increase in Height Velocity Over the Study Period 0 - 34 Weeks [Completers]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 0 -34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects completing Week 34 were included in the analysis.||cm/yr||Standard Deviation|Mean
170356|NCT00125190|Secondary|rhIGF-1 Doses Required to Achieve the Serum IGF-1 Targets With Measures Taken at Each Study Visit||34, 52 and 86 weeks||||||
170357|NCT00125190|Secondary|Percent Changes in Serum Concentration of Acid Labile Subunit (ALS) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of Serum Concentration of Acid Labile Subunit (ALS).|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.||percent||Full Range|Median
170358|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-3 (IGFBP-3) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.||percent||Full Range|Median
170359|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-2 (IGFBP-2) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-2 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 86 measurements were included in the analysis.||percent||Full Range|Median
170360|NCT00125190|Secondary|Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-1 (IGFBP-1) From Baseline to Week 86|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-1 in the growth factor panel.|86 weeks|Subjects who had both baseline and week 34 measurements were included in the analysis.||percent||Full Range|Median
170361|NCT00125190|Primary|Height Velocity Over the Study Period 34 - 86 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Weeks 34 to 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.||cm/yr||Standard Deviation|Mean
170362|NCT00125190|Secondary|Bone Age - Change From Pretreatment Minus Change in Chronological Age Over the Study Period 0 - 86 Weeks [Intent to Treat Population]|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Weeks 0 - 86|Subjects who had both baseline and week 86 measurements were included in the analysis.||years||Standard Deviation|Mean
170363|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 34 - 86 Weeks|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 34 - 86|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score. Only subjects continuing past Week 34 were included in the analysis.||SDs||Standard Deviation|Mean
170387|NCT00125034|Secondary|Progression-free Survival Time (KRAS Wild-Type Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Wild-Type population||months||95% Confidence Interval|Median
170364|NCT00125190|Secondary|Changes in Height Standard Deviation (SD) Score Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Weeks 0 - 34|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.||SDs||Standard Deviation|Mean
170365|NCT00125190|Primary|Height Velocity Over the Study Period 0 - 34 Weeks [Intent to Treat Population]|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|34 weeks|The ITT principle was used for the primary analysis, with imputation of missing height velocity and missing height SD score.||cm/yr||Standard Deviation|Mean
170366|NCT00125164|Post-Hoc|Change From Baseline in Height Standard Deviation (SD) Score at One Year - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||SD/year||Standard Deviation|Mean
170367|NCT00125164|Post-Hoc|Height Velocity During the First Year for Subjects - Completers|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|One Year|All randomized subjects who completed 12 months of treatment in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||cm/year||Standard Deviation|Mean
170368|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGFBP-3 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||mg/dL||Standard Deviation|Mean
170369|NCT00125164|Secondary|IGF Generation Test: Change of Serum IGF-1 After 7 Days Exposure to Recombinant Human Growth Hormone (rhGH)|Blood drawn at Study Day 1, followed by 7 days of rhGH daily dosing at 0.05 mg/kg of body weight. Additional blood draw at Study Day 7.|Study Day 1 and Day 7|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with measurements both pre and post exposure to rhGH. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||ng/mL||Standard Deviation|Mean
170370|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
170371|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2) at One Year|Blood sample was collected for measuring the level of insulin-like growth factor binding protein-2 (IGFBP-2) in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
170372|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-2 at One Year|Blood sample was collected for measuring the level of IGF-2 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
170373|NCT00125164|Secondary|Percent Changes From Baseline in Serum Concentrations of IGF-1 at One Year|Blood sample was collected while subject is in a fasting state for measuring the level of IGF-1 in the growth factor panel.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Percent change||Standard Deviation|Mean
170374|NCT00125164|Secondary|Changes in Bone Age From Baseline to One Year|Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.|Measured at baseline and at one year|All randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with baseline measurement and Month 12 measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||Year||Standard Deviation|Mean
170388|NCT00125034|Secondary|Progression-free Survival Time|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
170375|NCT00125164|Secondary|Change From Baseline in Height Standard Deviation (SD) Score at One Year - ITT Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.|Measured at baseline and at one year|A modified intention-to-treat population that consists of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||SD/year||Standard Deviation|Mean
170376|NCT00125164|Primary|Height Velocity During the First Year - Intent to Treat (ITT)Population|Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.|Measured at baseline and at one year|A modified intention-to-treat population consisting of all randomized subjects in the untreated control, 80 and 120 µg/kg BID groups with a baseline height measurement and at least one on-treatment height measurement. Subjects assigned to 40 μg/kg BID arm were excluded from the analysis due to the dose change to 120 μg/kg BID.||cm/yr||Standard Deviation|Mean
170377|NCT00125138|Secondary|Investigator/Caregiver Evaluations of Motor Function|The change in the motor section of the Unified Parkinson’s Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.||Scores on a scale||Standard Deviation|Mean
170378|NCT00125138|Primary|Patient Evaluation of Symptoms of Psychosis.|The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.|6 weeks (from Baseline to end of Maintenance Period)|All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.||Scores on a scale||Standard Error|Least Squares Mean
170379|NCT00125034|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first patient dose of study treatment, 27 Jul 2005, until cut-off date 30 Nov 2008|Safety Population||participants|||Number
170380|NCT00125034|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|Time from first assessment of Complete Response or Partial Response to disease progression,death or last tumor assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
170381|NCT00125034|Secondary|Disease Control Rate (Cut Off Date 4 August 2006)|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments as assessed by IRC (based on modified WHO criteria).|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||percentage of participants||95% Confidence Interval|Number
170382|NCT00125034|Secondary|Participants With No Residual Tumor After Metastatic Surgery|No residual tumor after on-study surgery for metastases.|Time from first dose up to 30 days after the last dose of study treatment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||participants|||Number
170383|NCT00125034|Secondary|Overall Survival Time (KRAS Mutant Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Mutant population||months||95% Confidence Interval|Median
170384|NCT00125034|Secondary|Overall Survival Time (KRAS Wild-Type Population)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 November 2008|KRAS Wild-Type population||months||95% Confidence Interval|Median
170385|NCT00125034|Secondary|Overall Survival Time|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|Primary analysis on ITT population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||months||95% Confidence Interval|Median
170386|NCT00125034|Secondary|Progression-free Survival Time (KRAS Mutant Population)|"Duration from randomization until radiological progression as assessed by an IRC (based on modified WHO criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008|KRAS Mutant population||months||95% Confidence Interval|Median
175307|NCT00078559|Secondary|Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||adverse events|||Number
170389|NCT00125034|Secondary|Best Overall Response Rate (KRAS Mutant Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Mutant population||percentage of participants||95% Confidence Interval|Number
170390|NCT00125034|Secondary|Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007|KRAS Wild-Type population||percentage of participants||95% Confidence Interval|Number
170391|NCT00125034|Primary|Best Overall Response Rate - Independent Review Committee (IRC)|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.|Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006|Primary analysis on the Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).||percentage of participants||95% Confidence Interval|Number
170392|NCT00124982|Secondary|LT; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-813|Treated participants with available serum samples for assay||participants|||Number
170393|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-baseline visit.|BL (Day 0), Days 365, 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
170394|NCT00124982|Secondary|Long-term Period: Mean SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Post-baseline Visits Over the Long Term|SF-36 measures health-related quality of life and has 36 questions with 8 subscale scores and 2 summary scores (1)physical component summary=physical functioning,role-physical,bodily pain,and general health; (2)mental component summary=vitality,social functioning,role-emotional,and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0=worst score and 100=best score. Post-BL values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365 and 729|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
170395|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|SF-36 has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health;(2) mental component summary=vitality,social functioning,role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score and 100=best score. Time-matched BL (Day 0) values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
170396|NCT00124982|Secondary|Long-term Period: Number of Participants Achieving Clinically Meaningful HAQ Response Over Time|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements.||participants|||Number
170404|NCT00124982|Secondary|Long-term Period: Mean Time-Matched Change From Baseline (Day 0) in Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||swollen joints||Standard Error|Mean
170397|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in HAQ-DI and HAQ-DI Components For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions assessing physical functions in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Domain questions evaluated on 4-point scale: 0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=sum of worst scores in each domain ÷ number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched mean change from BL= Post-BL value - time-matched BL value. Time-matched BL value=mean BL (Day 0)value for only that cohort with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
170398|NCT00124982|Secondary|Long-term Period: Mean HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Post-baseline Visits Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0(no difficulty), max overall score=3(unable to do). Post-BL values presented for each visit represent only that cohort of participants with measurements available at that post-BL visit.|Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean post-baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
170399|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) HAQ-DI and HAQ-DI Component Scores For Participant Cohorts at Each Corresponding Post-baseline Visit Over the Long Term|HAQ-DI includes 20 questions to assess physical functions in 8 domains:dressing, arising,eating,walking, hygiene, reach, grip and common activities. Domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. HAQ-DI= sum of worst scores in each domain divided by number of domains answered. HAQ-DI minimum=0 (no difficulty), max overall score=3(unable to do). Time-matched BL(Day 0)values presented for each post-BL visit represent only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0)|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
170400|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in VAS Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched mean change from BL = Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with data available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
170401|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Visual Analog Scale (VAS) and VAS for Post-Baseline Visits Over the Long Term|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
170402|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Hs-CRP Level Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||mg/dL||Standard Error|Mean
170403|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Hs-CRP Levels and Hs-CRP Levels for Post-Baseline Over the Long Term|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||mg/dL||Standard Deviation|Mean
170405|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Swollen Joints And Post-Baseline Number of Swollen Joints Over the Long Term|The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 66 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||swollen joints||Standard Deviation|Mean
170406|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in Number of Tender Joints Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline (Day 0) value for only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||tender joints||Standard Error|Mean
170407|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) Number of Tender Joints and Number of Tender Joints for Post-Baseline Visits Over the Long Term|The mean number of tender joints was evaluated based on the number of tender joints in a standard 68 joint count. Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||tender joints||Standard Deviation|Mean
170408|NCT00124982|Secondary|Long-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Over The Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL(Day 0)value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Error|Mean
170409|NCT00124982|Secondary|Long-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Over the Long Term|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0)values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Days 365, 449, 533, 617, 729, 813|All treated participants analyzed in the LT. N=the total number of participants analyzed, n=the number of participants at that time point with available measurements. Mean time-matched baseline values reflect changing n-values over time||units on a scale||Standard Deviation|Mean
170410|NCT00124982|Secondary|Long-term Period: Number of Participants With Clinically Meaningful Improvement in DAS 28, Low Disease Activity, or Remission Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Days 365, 449, 533, 617, 729, 813|All treated participants. n=number of evaluable participants.||participants|||Number
170411|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL, Day 169|All treated participants||units on a scale||Standard Deviation|Mean
170412|NCT00124982|Secondary|Short-term Period: Mean Baseline Fatigue Visual Analog Scale (VAS)|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|BL|All treated participants||units on a scale||Standard Deviation|Mean
170413|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL, Day 169|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
170414|NCT00124982|Primary|Long-term Period: Mean Temperature (T) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable temperature readings.||degrees Celsius||Standard Deviation|Mean
170415|NCT00124982|Primary|Long-term Period: Mean Heart Rate (HR) Over Time||From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable heart rate readings.||beats per minute||Standard Deviation|Mean
170416|NCT00124982|Primary|Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure readings.||mm Hg||Standard Deviation|Mean
170504|NCT00124579|Secondary|Toxicity|To evaluate the qualitative and quantitative toxicities associated with this regimen.|From date of protocol therapy start to date of protocol therapy end.|All participants receiving at least one dose of induction therapy||Participants|||Number
170417|NCT00124982|Primary|Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time|Measurements were taken in a seated position before and after abatacept infusion.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable blood pressure measurements.||mm Hg||Standard Deviation|Mean
170418|NCT00124982|Primary|LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time|Na NR=132 – 147 mEq/L, MA is 95* LLN/ >1.05* ULN, or if BL<LLN then use 0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN. K NR=3.3 – 5.5 mEq/L, MA is <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN. Cl NR=94 – 111 mEq/L, MA is <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||mEq/L||Standard Deviation|Mean
170419|NCT00124982|Primary|Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time|Bilirubin NR=0.2–1.2 mg/dL, MA: >2* ULN, or if BL>ULN then use >4* BL. BUN NR=4.0–24.0 mg/dL, MA: >2*BL. Creatinine NR=0.4–1.2 mg/dL, MA: >1.5*BL. Ca NR=8.8–10.2 mg/dL, MA: <0.8*LLN/>1.2*ULN, or if BL<LLN then use 0.75*BL or >ULN, or if BL>ULN then use>1.25*BL or <LLN. P NR=2.8–4.0 mg/dL, MA: <0.75*LLN/ >1.25*ULN, or if BL<LLN then use 0.67*BL or >ULN, or if BL>ULN then use>1.33*BL or <LLN. Glu MA: <65 mg/dL/ >220 mg/dL. Uric acid MA: >1.5*ULN, or if BL>ULN then use >2*BL.|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||mg/dL||Standard Deviation|Mean
170420|NCT00124982|Primary|Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time|HGB normal range (NR)=11.6 - 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 - 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 - 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||U/L||Standard Deviation|Mean
170421|NCT00124982|Primary|Long-term Period: Change From Baseline in White Blood Cells Over Time|Leukocytes NR=4.1 - 12.3*10^3 c/uL, MA is <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN. Neutrophils+bands MA is <1.0 * 10^3 c/uL. Eosinophils MA is >0.750 * 10^3 c/uL. Basophils MA is > 400 mm^3. Monocytes MA is >2000 mm^3. Lymphocytes MA is <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||10^3 c/uL||Standard Deviation|Mean
170422|NCT00124982|Primary|Long-term Period: Change From Baseline in Platelets (PLT) Over Time|Erythrocytes NR= 3.80 - 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||10^9 c/L||Standard Deviation|Mean
170423|NCT00124982|Primary|Long-term Period: Change From Baseline in Erythrocytes Over Time|Erythrocytes NR= 3.80 – 5.50 *10^6 c/uL, MA is <0.75 * BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||10^6 c/uL||Standard Deviation|Mean
170424|NCT00124982|Primary|Long-term Period: Change From Baseline in Hematocrit Over Time|The hematocrit value refers to the percentage of blood volume that is occupied by red blood cells. Hematocrit values for participants were expressed as percentages and were averaged to yield a group mean value (percentage) at a particular time point. The mean change from baseline in hematocrit value (expressed as a percent)= mean post-baseline value (expressed as a percent) - mean baseline value (expressed as a percent).|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||percentage change||Standard Deviation|Mean
170425|NCT00124982|Primary|Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time|HGB normal range (NR)=11.6 – 16.2 g/dL, marked abnormality (MA) is >3 g/dL decrease from BL. Total protein NR=6.0 – 8.4 g/dL, MA is <0.9* LLN/>1.1* ULN; Albumin NR=3.5 – 5.3 g/dL, MA is <0.9* LLN, or if BL<LLN then use <0.75 BL|BL, Day 365, Day 729|All treated participants in the OL. n=number of participants with evaluable laboratory results.||g/dL||Standard Deviation|Mean
170426|NCT00124982|Primary|Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
170427|NCT00124982|Primary|Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
170428|NCT00124982|Primary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2*ULN, or if BL>ULN, use >3*BL; aspartate aminotransferase (AST): >3*ULN, or if BL>ULN,use >4*BL; alanine aminotransferase (ALT): >3*ULN, or if BL>ULN, use >4*BL; G-Glutamyl transferase (GGT): >2*ULN, or if BL>ULN, use >3*BL; bilirubin: >2*ULN, or if BL>ULN, use >4*BL; blood urea nitrogen (BUN): >2*BL; creatinine: >1.5*BL|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
173477|NCT00096265|Secondary|Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument|Compared between two treatment arms using a two-group t-test.|From randomization to date of death or last follow-up. Analysis occurs after the primary outcome analysis.||||||
170429|NCT00124982|Primary|Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Marked abnormality criteria=Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes:<0.75*BL; Platelets: <0.67*LLN/>1.5 * ULN, or if BL<LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/>1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN,use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/>7.50*10^3 c/uL.|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|Participants who received at least 1 infusion of abatacept during the long-term treatment period. n=number of participants with evaluable laboratory results.||participants|||Number
170430|NCT00124982|Primary|Long-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants||participants|||Number
170431|NCT00124982|Primary|Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept|All treated participants||participants|||Number
170432|NCT00124982|Secondary|Short-term Period: Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|BL|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
170433|NCT00124982|Secondary|Short-term Period: Number of Participants Achieving a Clinically Meaningful HAQ Response|HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do). Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|BL, Day 169|All treated participants||participants|||Number
170434|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. HAQ-DI= sum of worst scores in each domain divided by the number of domains answered. HAQ-DI ranges from a minimum of 0 (no difficulty) to a maximum overall score of 3(unable to do).|BL, Day 169|All treated participants||units on a scale||Standard Deviation|Mean
170435|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF)|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process.|BL, Day 169|All treated participants||IU/mL||Standard Deviation|Mean
170436|NCT00124982|Secondary|Short-term Period: Mean Change From Baseline to Day 169 in High Sensitivity C-Reactive Protein (Hs-CRP)|hs-CRP is a acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Levels of hs-CRP can be used to determine DAS28.|BL, Day 169|All treated participants||mg/dL||Standard Deviation|Mean
170437|NCT00124982|Secondary|Short-term Period: Mean Time-matched Change From Baseline (Day 0) in DAS 28 Through 6 Month Open-Label|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from BL= Post-BL value - time-matched BL value, where the time-matched BL value represents the mean BL (Day 0) value for only that cohort of participants with measurements available at that post-BL visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
170438|NCT00124982|Secondary|Short-term Period: Mean Time-matched Baseline (Day 0) DAS 28 and DAS 28 for Post-Baseline Visits Through 6 Month Open-Label|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit, and represent only that cohort of participants with measurements available at that post-baseline visit.|BL (Day 0), Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|All treated participants. n=number of evaluable participants.||units on a scale||Standard Deviation|Mean
170439|NCT00124982|Primary|Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1-169|Treated participants with available serum samples for assay||participants|||Number
170440|NCT00124982|Primary|Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure||Day 1 (Baseline) -Day 169|Although mean values for systolic and diastolic blood pressure were recorded, mean changes from baseline were not summarized for these data.||mm Hg||Standard Deviation|Mean
170441|NCT00124982|Primary|Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria|Marked abnormality criteria: serum glucose (Glu):<65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8* LLN/>1.5* ULN, or if BL<LLN then use 0.8* BL or >ULN, or if BL>ULN then use >2.0* BL or <LLN; total protein: <0.9* LLN/>1.1* ULN; albumin: <0.9* LLN,or if BL<LLN then use <0.75 BL; uric acid: >1.5* ULN, or if BL>ULN then use >2* BL. Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or value ≥4,or when pre-dose=0 or 0.5. Use ≥3 when pre-dose=1. Use ≥4 when pre-dose=2 or 3|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
170442|NCT00124982|Primary|Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria|Marked abnormality criteria:Sodium (Na): <0.95* LLN/ >1.05* ULN,or if BL<LLN then use 0.95* BL or >ULN,or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1* ULN,or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; chloride: <0.9* LLN/>1.1* ULN, or if BL<LLN then use 0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use 0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
170443|NCT00124982|Primary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Days 1-169|All treated participants. n=number of participants with evaluable laboratory results.||participants|||Number
170444|NCT00124982|Primary|Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Days 1-169|Participants who received at least 1 infusion of abatacept during the short-term treatment period||participants|||Number
170445|NCT00124982|Secondary|Short-term Period: Number of Participants With Clinically Meaningful Improvement (CMI) in Disease Activity Score (DAS 28), Low Disease Activity (LDAS), or Remission at Day 169|The DAS 28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|BL, Day 169|All treated participants.||participants|||Number
170446|NCT00124982|Primary|Short-term Period: Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Days 1-169|All treated participants||participants|||Number
170447|NCT00124982|Primary|Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|Days 1-169|All treated participants||participants|||Number
170448|NCT00124943|Secondary|Percentage of In-Stent Volume Obstruction at 6 Months|In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume * 100.|6 months|Treated population for whom data was available.||Percentage of obstruction||Standard Deviation|Mean
170449|NCT00124943|Secondary|Late Lumen Loss|"Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography.~Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up."|Day 0 (post-procedure baseline) and 6 months.|"Treated population for whom data was available (indicated by n)."||mm||Standard Deviation|Mean
170450|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to Month 6.|Treated population.||participants|||Number
170451|NCT00124943|Primary|Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month|Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.|From the day of Percutaneous Coronary Intervention to 1 Month.|Treated population.||participants|||Number
170452|NCT00124943|Secondary|Percentage of Participants With Binary Restenosis|Binary restenosis was assessed by quantitative coronary angiography and defined as >50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.|6 months|Treated Population.||percentage of participants|||Number
170453|NCT00124943|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|"An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.~An SAE is any event that:~is fatal or life threatening~results in persistent or significant disability or or incapacity;~requires or prolongs existing hospitalization;~is a congenital anomaly/birth defect in the offspring of a patient who received medication;~conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above."|Up to 6 months.|Treated population.||participants|||Number
170454|NCT00124943|Primary|Number of Participants With Procedural Complications|"Procedural complications include the following:~Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes;~Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia;~Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema;~Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow;~Clinical changes: chest pain."|From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).|Treated population.||participants|||Number
170455|NCT00124943|Primary|Phase I: Number of Participants With Dose-limiting Toxicities|"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting.~The maximum tolerated dose was defined as the lesser of 45 mg/m^2 or the dose at which any drug related toxicities were observed."|Up to 1 week following percutaneous coronary intervention.|Phase I treated population.||participants|||Number
170456|NCT00124748|Secondary|Number of Participants With the Effect of Imatinib on the Diabetic Participants With Known Concomitant Type II Diabetes||12 months|Due to the small number of diabetic patients enrolled into the study, the analysis was never done.||Participants|||Number
170457|NCT00124748|Secondary|Time to First Complete Molecular Response (CMR)]|Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene.|48 months overall|This analysis was not done because no major molecular improvement was observed in the 800mg dose compared to 400mg dose. Hence, analysis for complete molecular response was not necessary.||Months||95% Confidence Interval|Median
170458|NCT00124748|Secondary|Estimated Rates of Progression Free Survival (PFS) on Treatment by Major Molecular Response (MMR)|A Landmark Kaplan-Meier analysis was performed for PFS at 42 months by MMR status at 6, 12, and 18 months to investigate their prognostic value.|42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment. Patients without a valid polymerase chain reaction (PCR) assessment or those who had experienced an event before the landmark were excluded from analysis||Percent probability||95% Confidence Interval|Number
170459|NCT00124748|Secondary|Imatinib Pharmacokinetic Trough Plasma Concentration (Cmin) at Month 12|Imatinib PK trough plasma concentration (Cmin) was defined as any pre-dose Imatinib plasma concentration|Month 12|Pharmakokinetic (PK) population consisted of number of patients with a pre-dose PK sample at Month 12||mg/mL||Standard Deviation|Mean
170460|NCT00124748|Secondary|Mean Actual Dose Intensity Per Day|The mean actual dose intensity per day from start of treatment up to last dose or discontinuation was evaluated up to Month 36. Actual dose intensity (mg/day) = total dose/time on treatment (periods of zero dose are included)|start of treatment to Month 36|Safety analysis population (SAP): consisted of all patients who received at least one dose of study medication.Subjects are summarized according to the safety treatment allocation (the dose they actually received).||mg/day||Standard Deviation|Mean
170461|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Complete Cytogenetic Response (CCyR)|Duration of CCyR was defined as the time between date of CCyR and the earliest of either (1) loss of CCyR OR (2) (Chronic Myeloid Leukemia) CML-related death or progression to (Accelerated Phase/Blast Crisis) AP/BC during study treatment. Estimated rate of duration of first CCyR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From first complete cytogenetic response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
170462|NCT00124748|Secondary|Kaplan-Meier Estimates of Duration of First Major Molecular Response Until Confirmed Loss|Duration of MMR (months) = (date of first confirmed loss or censoring - date of MMR + 1 ) / 30.4375. Estimated rate of duration of first MMR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|From First major molecular response to first confirmed loss or censoring|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
170463|NCT00124748|Secondary|Estimated Rate of Overall Survival (OS) in Two Treatment Arms|OS was defined as time between randomization and death due to any cause during study treatment or during follow-up after discontinuation of treatment. Estimated rate of OS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
170464|NCT00124748|Secondary|Estimated Rate of Progression to Accelerated Phase (AC)/Blast Crisis (BC) in Two Treatment Arms|(Accelerated Phase/Blast Crisis) AP/BC was defined as time between randomization and either (1) (Chronic Myeloid Leukemia) CML-related death (if death was primary reason for discontinuation) or (2) progression to AP or BC (during treatment). Estimated rate of AC/BC was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
170465|NCT00124748|Secondary|Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms|PFS on study which was defined as time between randomization and either (1) death due to any cause on treatment of during follow-up after discontinuation of treatment or (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment during follow-up after discontinuation of study treatment. Estimated rate of PFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all and follow up period|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
170466|NCT00124748|Secondary|Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms|EFS on treatment was defined as time between randomization and either (1) death due to any cause during study treatment, (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment, (3) loss of complete hematological response (CHR), or (4) loss of major cytogenic response (MCyR) while on treatment. Estimated rate of EFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).|60 months over all|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percent probability||95% Confidence Interval|Number
170467|NCT00124748|Secondary|Time to First Complete Hematological Response (CHR)]|Complete Hematological Response (CHR) is defined is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement. Time to CHR (months) = (date of first CHR or censoring - date of randomization + 1) / 30.4375. Time to first CHR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Months||95% Confidence Interval|Median
170468|NCT00124748|Secondary|Time to First Complete Cytogenetic Response|Cytogenetic response (CyR) is the percentage of Philadelphia positive metaphases (among at least 20 metaphase cells in Bone Marrow) with Complete Cytogenetic Response (CCyR) being 0 percent. Time to CCyR (months) = (date of first CCyR or censoring - date of randomization + 1) / 30.4375. Time to first CCyR was evaluated using the Kaplan-Meier method.|60 months overall|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Months||95% Confidence Interval|Median
170469|NCT00124748|Secondary|Time to First Major Molecular Response|"MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).~Time to MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375. Time to first MMR was evaluated using the Kaplan-Meier method"|42 months overall|Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment.||Months||95% Confidence Interval|Median
170470|NCT00124748|Secondary|Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts|"Undetectable levels or Complete molecular response is defined as Bcr-Abl ratio (%) on international scale (IS) <= 0.0032% (≥ 4.5 log reduction of BCR-Abl transcripts from a standardized baseline)."|12 , 24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who were randomized into the study.||Percentage of Partcipants|||Number
170471|NCT00124748|Secondary|Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months|Complete Hematologic Response (CHR) is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement.|12, 24, 36, and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of participants|||Number
170472|NCT00124748|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months|Cytogenetic response (CyR)is the percentage of Philadelphia chromosome positive metaphases (among at least 20 metaphase cells in bone marrow (BM)) with Complete Cytogenetic Response (CCyR) being 0 percent.|12, 24, 36, 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of Participants|||Number
170473|NCT00124748|Secondary|Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|24, 36 and 42 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of participants|||Number
170474|NCT00124748|Primary|Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months|MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).|12 months|Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.||Percentage of participants|||Number
170475|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%|The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population||minutes||Standard Deviation|Mean
170476|NCT00124735|Secondary|Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%|The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population||minutes||Standard Deviation|Mean
170477|NCT00124735|Secondary|Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%|The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).|after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)|per-protocol population||minutes||Standard Deviation|Mean
170478|NCT00124735|Primary|Total Dose of Zemuron (Rocuronium) Administered|Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set)|during surgery|Per protocol population||mg/kg||Standard Deviation|Mean
170479|NCT00124709|Secondary|Patient/Caregiver Quality of Life|Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.|From Baseline to Visit 5 , 6, 8, 10, 12, and 14|Intent-to-Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.||Scores on PIQoL-AD Scale||Standard Deviation|Mean
170480|NCT00124709|Secondary|Atopic Dermatitis (AD) Remission Time|"Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response (yes) to the question No or almost no eczema? and a response of no treatment except emollients to the question Medication used."|36 month Double-Blind Phase|Intent-to-Treat population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.||Days||Standard Deviation|Mean
170481|NCT00124709|Secondary|Corticosteroid and Pimecrolimus Drug Use|"Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase.~Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months."|48 months|Safety population: all randomized patients who were dispensed study medication.||Days of Exposure||Standard Deviation|Mean
170482|NCT00124709|Secondary|Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies|"Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.~Note: The results at six years are not reported due to early termination of the study."|6 years (36 month Double-Blind Phase)|Intent to Treat Population defined as all randomized patients who were dispensed study medication and had at least one post-baseline efficacy measurement.||Percentage of Participants|||Number
170483|NCT00124709|Secondary|Long Term Safety in Infants and Young Children|Note: The results of this secondary outcome is not reported due to early termination of the study.|6 years||||||
170484|NCT00124709|Primary|Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age|Note: The results for this efficacy variable are not reported due to early termination of the study.|6 years||||||
170485|NCT00124709|Primary|Atopic Dermatitis (AD) Disease Control Over 36 Months|Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.|36 months|Intent to Treat Population: all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.||Proportion of disease free days||Standard Deviation|Mean
170486|NCT00124657|Secondary|Number of Participants Experiencing Grade 3 or 4 Toxicity Events|Adverse events were collected systematically for each of the 44 Phase II participants from the time of enrollment to the completion of therapy (approximately 2 years from start of therapy).|From start of therapy through 2 years.|All 44 Phase II participants were evaluated. Eight of 16 participants with lymphopenia received dexamethasone within 4 weeks of the recorded toxicity. In both participants with headache, there was a documented progressive disease within 3 days of the recorded headache.||Participants|||Number
170487|NCT00124657|Secondary|Plasma and CSF Levels of VEGF, bFGF, and SDF1|This objective was to determine the plasma and CSF levels of the VEGF, bFGF, and SDF1 at diagnosis, and the plasma levels of these factors at regular intervals during therapy, and to analyze the association of these results with tumor response.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.|||||
170488|NCT00124657|Secondary|To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity||5 Years|This objective became obsolete over the course of the protocol, and data was not collected.|||||
170489|NCT00124657|Secondary|Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment|This objective was to prospectively investigate the correlation between standard magnetic resonance imaging (MRI) and investigational radiologic techniques (MR spectroscopy, perfusion/diffusion, PET scan, DEMRI/BLAST) in assessing tumor response to this treatment.|at diagnosis and regular intervals during therapy (up to 2 years after start of therapy)|This objective became obsolete over the course of the protocol, and data was not collected.|||||
170490|NCT00124657|Secondary|Ability of Erlotinib to Inhibit EGFR Signaling|"The objective was to test the ability of erlotinib to inhibit the EGFR signaling in patients with high-grade glioma who required a second surgery.~This outcome was not assessed due to insufficient availability of tumor and control samples for analysis."|5 Years|This outcome was not assessed due to insufficient availability of tumor and control samples for analysis.|||||
170491|NCT00124657|Primary|Progression Free Survival (PFS)|"Progression-free survival (PFS) distributions for the Phase II participants with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were calculated using Kaplan-Meier estimates (n=41). PFS was defined as the interval between treatment start and initial failure, including clinical or radiologic progression or death from any cause.~PFS was not calculated for the other disease types."|1 and 2 years after end of therapy|Per protocol, 41 participants with either anaplastic astrocytoma or glioblastoma multiforme were analyzed for this outcome.||years||Standard Deviation|Mean
170492|NCT00124657|Primary|Maximum Tolerated Dose (MTD) of Erlotinib|MTD was defined as the highest dosage level in which no more than one of six assessable participants experienced dose-limiting toxicities (DLT). The dosage of erlotinib was increased by approximately 30% in each dosage level starting at 80% of the MTD in adults with solid tumors. A traditional 3+3 dose escalation scheme was used to estimate the MTD.|During the first 8 weeks of therapy.|22 participants were analyzed for MTD over 4 dose levels. One of 23 enrolled participants was not evaluable due to early disease progression.||mg/m^2|||Number
170493|NCT00124657|Secondary|Number of Positive Mutations of EGFR and Downstream Pathways|"Statistical analyses of genomic changes, expression profiles and validation studies should be considered in an exploratory and hypothesis-generating context.~Fresh frozen tumor tissue was obtained at the time of tumor resection and diagnosis. DNA was extracted from formalin-fixed, paraffin-embedded tissue. The entire PTEN coding sequence (exons 1-9), exons 1, 9 and 20 of PIK3CA, and exons 17-24 of EGFR were evaluated using exon-specific PCR amplification, and immunohistochemistry was done. Tumor lesions were considered positive if >25% cells were immunoreactive."|Once at tumor resection and diagnosis|Unstained slides were available for immunohistochemistry analysis in 21 of the 23 Phase I participants.||participants|||Number
170494|NCT00124657|Secondary|AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.||mg*h/mL||Full Range|Median
170495|NCT00124657|Secondary|Erlotinib Tmax|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.||hours||Full Range|Median
170496|NCT00124657|Secondary|Cmax of Erlotinib and Its Metabolite OSI-420|Although the calculated dose of erlotinib was rounded to the nearest 25 mg, the actual dosage administered to patients was within 12% of the prescribed dosage in all but 1 patient. The latter patient received erlotinib at the lowest dosage level and the actual dosage was 19% higher than the calculated dose.|After first dose of therapy, and Day 8 of therapy|Pharmacokinetic variables were obtained in 17 patients enrolled on the Phase I portion of the study.||mg/mL||Full Range|Median
170497|NCT00124657|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0.|During the first 8 weeks of therapy|23 participants were enrolled on Phase I component; 22 were analyzed for DLT over 4 dose levels. 1 treated at dose level 120mg/m^2 was not assessable for DLT due to early tumor progression. 4 were treated before and 19 after the study was amended to exclude grade 3 and 4 electrolyte abnormalities that resolved to ≤ grade 2 within 7 days.||participants|||Number
170498|NCT00124618|Secondary|Tumor Response (Complete and Partial)|A confirmed tumor response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 3 months apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|Baseline, 1 month and 4 months after completion of treatment and then every 3 months until Progressive Disease (PD) or up to a maximum of 3 years from registration|||participants|||Number
170499|NCT00124618|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|From Baseline to up to 3 years|||months||95% Confidence Interval|Median
170500|NCT00124618|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From baseline to up to 3 years|||months||95% Confidence Interval|Median
170501|NCT00124618|Primary|11-month Survival Rate|Eleven-month survival was chosen as the survival endpoint in this trial because it represents an improvement over the median survival that is observed with radiation alone. 11-month survival will be considered synonymous with “success”, unless specified otherwise. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. All evaluable patients will be followed from the time of protocol enrollment until death or a minimum of 11 months.|From baseline to 11 months.|This study enrolled a total of 58 patients. All patients received study treatment, and one patient was deemed ineligible during an NCCTG audit. This analysis includes all 57 patients. Forty of 57 patients (70%) reached the 11-month survival primary point.||percentage of participants|||Number
170502|NCT00124579|Secondary|Progression-Free Survival|From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years|about 12-18 months|With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.||Months||95% Confidence Interval|Median
170503|NCT00124579|Primary|Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).|"Responses are defined as follows:~Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.~Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein < 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.~Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level."|1 year|Ninety patients is sufficient to distinguish between the null hypothesis that the response rate is 45% versus the alternative of a response rate of 60% with 89% power, using a one-sided test based on the binomial distribution with a significance level of 5%.||percentage of participants|||Number
170505|NCT00124449|Secondary|Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies|Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of > 400 and for tip assessment was ≥25.|Up to 12 months|||participants|||Number
170506|NCT00124449|Secondary|Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths|AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely|Throughout the treatment period (6 months)|All subjects who received at least 1 dose of study medication||Participants|||Number
170507|NCT00124449|Secondary|Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response|This questionnaire includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. Higher scores indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).||Participants|||Number
170508|NCT00124449|Secondary|Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)|The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (< 2.6).|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).||Participants|||Number
170509|NCT00124449|Secondary|DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline|The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=the number of participants with baseline and postbaseline measurements).||units on a scale||Standard Error|Mean
170510|NCT00124449|Secondary|Frequency of Human Leukocyte Antigen (HLA) Typing|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).|Day 1|All randomized and treated participants||participants|||Number
170511|NCT00124449|Secondary|Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time|To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive|Day 1, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with measure at timepoint).||Participants|||Number
170512|NCT00124449|Secondary|Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months|To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], tumor necrosis factor Alpha [TNF-Alpha], Matrix Metalloproteinase 3T [MMP3T], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.|Baseline, 6 Months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements).||laboratory values||Standard Error|Mean
170513|NCT00124449|Secondary|Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline|SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.|6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements)||units on a scale||Standard Error|Mean
170514|NCT00124449|Secondary|Number of Participants With Persistent Symptomatic Clinical Synovitis|Synovitis, assessed by clinical signs and symptoms|6, 12, and 24 months|All randomized and treated participants (n=number of participants with assessment at baseline and timepoint)||Participants|||Number
170515|NCT00124449|Secondary|Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months|Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.|Baseline, 6 months, 12 months, 24 months|All randomized and treated participants (n=number of participants with baseline and postbaseline measurements). MRIs were done only in participants at European Union sites.||units on a scale||Standard Error|Mean
170516|NCT00124449|Secondary|Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months|Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.|Baseline, 6 months, 12 months, 24 months|n=participants with a score at baseline and at timepoint||units on a scale||Standard Error|Mean
170542|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Suspected Recurrent DVT in Whom Disease Recurrence Has Been Excluded||May 2007|Number of participants with suspected recurrent DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
170543|NCT00123734|Primary|To Provide Estimates of the Specificity of [99mTc] ThromboView® in Patients With Excluded Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
170517|NCT00124449|Secondary|Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease|Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|12 months, 24 months|n=Randomized and treated participants who were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in the 1- or 2-year window were excluded from the analysis).1 participant in Placebo group was excluded due to the presence of RA at baseline.||Participants|||Number
170518|NCT00124449|Secondary|Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.|24 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 2-year window were excluded from the analysis). 1 subject in the Placebo group is excluded due to presence of RA at baseline.||Participants|||Number
170519|NCT00124449|Primary|Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy|ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.|12 months|Randomized and treated participants were included in analysis if they were RA positive and/or were discontinued due to lack of efficacy. (Those who discontinued due to reasons other than lack of efficacy in 1-year window were excluded from the analysis). 1 participant in Placebo group was excluded due to presence of RA at baseline.||Participants|||Number
170520|NCT00124176|Secondary|Serum Albuterol S Isomer Levels||After 6 hours of continuous albuterol|||ng/mL||Standard Deviation|Mean
170521|NCT00124176|Secondary|Serum Potassium Levels||After 12 hours of continuous nebulization|||mg/dL||Standard Deviation|Mean
170522|NCT00124176|Secondary|Heart Rate||After 12 hours of continuous nebulization|||beats per minute||Standard Deviation|Mean
170523|NCT00124176|Secondary|Change in Pediatric Asthma Severity Score|"Change in Pediatric Asthma Severity Score. Range 0 (best) - 6 (worst)~Score at each time point is calculated by adding 3 elements:~Wheeze (0= None/Mild, 1=Moderate, 2=Severe) Prolonged expiration (0= None/Mild, 1=Moderate, 2=Severe) Work of breathing (0= None/Mild, 1=Moderate, 2=Severe)"|After 12 hours of continuous nebulization|||units on a scale||Standard Deviation|Mean
170524|NCT00124176|Primary|Duration of Continuous Therapy|standard intention to treat (ITT) analysis|During hospitalization|||Hours||Inter-Quartile Range|Median
170525|NCT00124072|Secondary|Total Strokes||6.7 years median follow-up||||||
170526|NCT00124072|Secondary|Major Coronary Events|Non-fatal MI, coronary death or coronary revascularisation|6.7 years median follow-up||||||
170527|NCT00124072|Secondary|MVEs in Presence and Absence of the Other Factorial Treatment||6.7 years median follow-up||||||
170528|NCT00124072|Secondary|MVEs in Patients Subdivided Into 3 Groups by Baseline Low-density Lipoprotein (LDL)||6.7 years median follow-up||||||
170529|NCT00124072|Secondary|MVEs Separately in Year 1 and in Later Years||6.7 years median follow-up||||||
170530|NCT00124072|Primary|Major Vascular Events (MVE)|Major vascular events (MVE) defined as major coronary events (MCE [non-fatal MI, coronary death or coronary revascularisation]), non-fatal or fatal stroke, or peripheral revascularization (peripheral artery angioplasty or arterial surgery, including amputations), during the scheduled study treatment period.|6.7 years median follow-up|||Participants|||Number
170531|NCT00124020|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)~Failure - at least one of the following:~Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy~Termination of study med due to “lack of efficacy”~Death on or after Day 3 attributable to primary infection~Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.~Indeterminate: Inability to determine outcome"|7-14 days following end of antibiotic treatment|||participants|||Number
170532|NCT00123955|Secondary|Left Ventricular Diastolic Stiffness||Baseline, 4 and 9 months||||||
170533|NCT00123955|Secondary|Concentric Left Ventricular Remodeling||Baseline, 4 and 9 months||||||
170534|NCT00123955|Primary|Quality of Life||Baseline, 4 and 9 months||||||
170535|NCT00123955|Primary|Exercise Intolerance|Peak exercise VO2|Baseline, 4 and 9 months|The outcome measure data uses data from all participants with 4 and/or 9 month follow-up. Thirty-seven participants randomized to spironolactone and 35 participants randomized to placebo completed 4 months of follow-up, and 37 participants randomized to spironolactone and 34 participants randomized to placebo completed 9 months of follow-up.||ml/kg/min||Standard Deviation|Mean
170536|NCT00123734|Secondary|To Provide Estimates of the Sensitivity and Specificity of [99mTc] ThromboView® for DVT at the 1-hour and 3-hour Imaging Time Points||May 2007||||||
170537|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Sensitivity||95% Confidence Interval|Mean
170538|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Distal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
170539|NCT00123734|Primary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® in Patients With Confirmed Initial DVT.||September 2005|||% Sensitivity||95% Confidence Interval|Mean
170540|NCT00123734|Secondary|To Provide Estimates of the Sensitivity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Sensitivity||95% Confidence Interval|Mean
170541|NCT00123734|Secondary|To Provide Estimates of the Specificity of [99mTc] ThromboView® for Imaging Suspected Proximal Initial DVT||May 2007|Number of participants with suspected initial DVT with evaluable images||% Specificity||95% Confidence Interval|Mean
170544|NCT00123682|Secondary|Self-reported Quit Attempt||6 months|||percentage of participants|||Number
170545|NCT00123682|Secondary|Use of Cessation Medications||6 months|||percentage of participants|||Number
170550|NCT00123487|Secondary|Number of Participants With Maximal QTcF Intervals up to Year 2 in Treated Participants|A12-lead ECG was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Day 8 and 29. Additional ECGs were done at the Investigator’s discretion. ECGs were read centrally. QT Interval corrected with Fridericia formula was measured in msec.|Baseline up to Year 2|All participants who received at least one dose of study drug and had appropriate ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
170551|NCT00123487|Secondary|Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants|A12-lead electrocardiogram (ECG) was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Days 8 and 29. Additional ECGs were done at the Investigator’s discretion. ECGs were read centrally. The QT interval corrected with Fridericia formula is presented with categories of changes from baseline (BL) in milliseconds (msec).|Baseline to Year 2|All participants who received at least one dose of study drug and had appropriate baseline and on-study ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
170552|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Biochemistry Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the NCI CTC version 3.0. Grade 3 and 4 criteria were defined as follows: Upper limit of normal (ULN). Alanine transaminase (ALT) Grade (Gr) 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase (AST) Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. Serum creatinine (H) Gr 3: >3.0 to 6.0*ULN; Gr 4: >6.0*ULN. Calcium (L) Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; Phosphorus (L): Gr 3: <2.0 – 1.0 mg/dL , Gr 4: <1.0 mg/dL. Non-hematologic laboratory results were not collected beyond Year 2. Baseline values were obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Participants who did not have a parameter reported at baseline are indicated.||participants|||Number
170553|NCT00123487|Secondary|Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0. Grade 4 hematology evaluations used to determine myelosuppression included: WBC: <1.0*10^9/L. ANC: <0.5*10^9/L. Platelet count <25.0 to 10^9/L.|Day 1 up to Year 7|All participants who received at least one dose of study drug and had laboratory evaluations available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
170554|NCT00123487|Secondary|Number of Participants With Normal Baseline Versus Worst Grade 3/4 Hematology Laboratory Abnormalities up to Year 2 in Treated Participants|Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) version 3.0. CTC Grade 3 and 4 criteria are defined as follows: White blood cells (WBC): Grade (Gr) 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Baseline was laboratory value obtained within 2 weeks prior to randomization.|Baseline to Year 2|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive. Those participants who did not have a parameter reported at baseline are indicated.||participants|||Number
170555|NCT00123487|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants|With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.|Day 1 to Year 7|All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.||participants|||Number
170556|NCT00123487|Secondary|Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population|PFS was defined as time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. OS was defined as time from randomization until date of death. Participants who had not died or were lost to follow-up were censored on the last date they were known to be alive. Median duration was measured in months.|24 months, 36 months, 48 months, 60 months|Participants were analyzed based on the treatment they were randomized to receive. Kaplan-Meir estimates of PFS or OS (95% Confidence Interval) are provided below.||percentage of participants||95% Confidence Interval|Number
170557|NCT00123487|Secondary|Median Overall Survival (OS) - Randomized Population|OS was defined as time from randomization until date of death. Participants who had not died or who were lost to follow-up were censored on the last date on which the participant was known to be alive. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.||Months||95% Confidence Interval|Median
170619|NCT00122681|Secondary|HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)|Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).|Month 0, 7, 12, 24|The analyses was performed on the Total Vaccinated cohort on subjects with available results.||EL.U/mL||95% Confidence Interval|Geometric Mean
170558|NCT00123487|Secondary|Median Progression Free Survival (PFS) - Randomized Population|PFS was defined as: Time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. Median duration was measured in months.|Randomization up to 5 Years|Participants were analyzed based on the treatment they were randomized to receive.||Months||95% Confidence Interval|Median
170559|NCT00123487|Secondary|Number of Participants With Best Cytogenic Response (CyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.||participants|||Number
170560|NCT00123487|Secondary|Percent of Participants With Major Cytogenetic Response (MCyR) - Randomized Population|Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM; Major cytogenetic response (MCyR) was defined as CCyR or PCyR. Percentage: number of participants with MCyR and denominator is number of randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
170561|NCT00123487|Secondary|Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population|Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and <100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Minor Hematologic Response (MiHR): <15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR.|Randomization up to 6 months, 2 years|Participants were analyzed based on the treatment they were randomized to receive.||participants|||Number
170562|NCT00123487|Secondary|Percent of Participants With Overall Hematologic Response - Randomized Population|Overall Hematologic Response (OHR) was defined as CHR, NEL or minor hematologic response (MiHR). CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. MiHR defined as: < 15% blasts in BM and in PB; < 30% blasts + promyelocytes in BM and PB; < 20% basophils in PB; No extra-medullary disease other than spleen and liver. Percentage: participants with OHR/ randomized participants.|Randomization up to 6 Months, 2 Years|Participants were analyzed based on the treatment they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
170563|NCT00123487|Secondary|Median Duration of a Major Hematologic Response (MaHR) in Those Participants Who Achieved a MaHR During the Study|MaHR was defined by either CHR or no evidence of leukemia NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. Median duration was measured in months.|Day 1 up to 5 years|Participants who achieved a MaHR during the study.||Months||95% Confidence Interval|Median
170564|NCT00123487|Secondary|Median Time to Major Hematologic Response (MaHR) - Randomized Population|A participants' time to MaHR was defined as the time from the first dosing date until criteria are first met for CHR or NEL, whichever occurred first. Non-responders were censored at the maximum of the date of last hematologic or cytogenetic assessment. Median time was measured in months.|Day 1 up to 6 months (time of primary endpoint), 2 years|Participants were analyzed based on the treatment they were randomized to receive.||Months||95% Confidence Interval|Median
170565|NCT00123487|Secondary|Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population|MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.||percentage of participants||95% Confidence Interval|Number
170566|NCT00123487|Secondary|Percent of Participants With Major Hematological Response (MaHR) With 2 Years of Follow-up From Date of Last Enrollment - Randomized Population|A MaHR was defined as a participant having either CHR or NEL. CHR was defined as: WBC ≤ ULN; ANC ≥ 1,000/mm^3; - platelets ≥ 100,000/mm^3; - no blasts or promyelocytes in PB; BM blasts ≤ 5%; < 5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by the same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percent: number of participants with MaHR /number of participants randomized.|Randomization up to 2 years|Participants were analyzed based on the treatment they were randomized to receive.||percentage of participants||95% Confidence Interval|Number
170567|NCT00123487|Primary|Percent of Participants With Major Hematologic Response (MaHR) With 6 Months of Follow-up From Date of Last Enrollment - Randomized Population|MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm^3; platelets ≥ 100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; <5% myelocytes plus metamyelocytes in PB; basophils in PB < 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm^3 and < 100,000/mm^3; ANC > 500/mm^3 and <1,000/mm^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule. Percentage: number of participants with MaHR/number of randomized participants.|Randomization up to 6 months|Participants were analyzed based on the treatment they were randomized to receive (not what they actually received). 95% exact confidence interval (CI) presented.||percentage of participants||95% Confidence Interval|Number
170568|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led toTreatment Discontinuation After 7 Year Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants. After the 2-year analysis and Protocol Amendment 02, those on a BID dosing schedule were allowed to switch to a QD dosing schedule. Due to the large number of participants switching from BID dosing to QD dosing, the abbreviated dosing data collection method incorporated in Amendment 03, the overall safety data are presented for the 100 mg QD group and combined for the other treatment groups.|Baseline to 30 days post last dose, up to 7 years (study closure July 2014)|All randomized participants who received at least one dose of study drug were summarized.||participants|||Number
170569|NCT00123474|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Treatment Discontinuation at 24 Months of Follow-up|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Baseline=closest to, but no later than, the first day of study drug for treated participants.|Baseline to 30 days post last dose, up to 24 months|All randomized participants who received at least one dose of study drug were summarized.||participants|||Number
170570|NCT00123474|Secondary|Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.||percentage of participants||95% Confidence Interval|Number
170571|NCT00123474|Secondary|Percent of Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up by Dose Schedule and Total Daily Dose - All Randomized Participants|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All participants who were randomized to a treatment arm were summarized.||percentage of participants||95% Confidence Interval|Number
170572|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 24 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date. No cytogenic assessments were made after 2 years of follow-up.|24 months|All randomized participants were summarized.||percentage of participants||95% Confidence Interval|Number
170573|NCT00123474|Secondary|Percent of All Randomized Participants With Cytogenic and Hematologic Response by Dosing Schedule (QD or BID) and by Total Daily Dose (100 mg or 140 mg) at 6 Months Follow-Up|Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM. Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM. MCyR: best cytogenetic response of CCyR or PCyR. A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months|All randomized participants were summarized.||percentage of participants||95% Confidence Interval|Number
170574|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants were summarized.||percentage of participants||95% Confidence Interval|Number
170575|NCT00123474|Secondary|Percent of Imatinib Intolerant Participants With Progression Free Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-intolerant participants with available data were summarized||percentage of participants||95% Confidence Interval|Number
170576|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With CHR at 6 Months and at 24 Months Follow-Up|A CHR was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-intolerant participants were summarized.||percentage of participants|||Number
170577|NCT00123474|Secondary|Percent of Participants Intolerant to Imatinib With MCyR at 6 Months and at 24 Months Follow-Up, by QD and BID Schedules and by Total Daily Dose|CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR.|6 months, 24 months|All randomized imatinib-intolerant participants with available data were summarized.||percentage of participants||95% Confidence Interval|Number
170578|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.||percentage of participants||95% Confidence Interval|Number
170579|NCT00123474|Secondary|Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up|PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to > 20,000/mm^3 or an increase by > 50,000/mm^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.|24, 36, 48, 60, 72, and 84 months|All randomized imatinib-resistant participants were summarized.||percentage of participants||95% Confidence Interval|Number
170580|NCT00123474|Secondary|Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants|BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).|Baseline up to 24 months|All randomized, treated participants with available mutation data were summarized.||participants|||Number
170590|NCT00123422|Secondary|Inspiratory Capacity|Inspiratory capacity measured during exercise is a measure of air-trapping (dynamic hyperinflation). Inspiratory capacity was measured at an isotime (same time) during the constant workrate treadmill test at baseline and 14 weeks.|14 weeks|Intent-to-treat analysis was used so data on all randomized patients were analyzed.||Liters||Standard Deviation|Mean
170773|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
170581|NCT00123474|Secondary|Number of Participants With CHR Whose Disease Progressed by 24 Months|Progression in a participant=achieved a CHR and subsequently no longer met the criteria consistently over a consecutive 2-week period after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; met the criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of CHR, medium duration of CHR could not be estimated because the majority of participants with CHR continued to respond, or could not be reliably estimated because of the large number of censored participants.|24 months|All imatinib-resistant participants who achieved CHR and then experienced disease progression were summarized.||participants|||Number
170582|NCT00123474|Secondary|Number of Participants With MCyR Whose Disease Progressed by 24 Months|Progression in a participant=participant achieved a CHR and no longer met the criteria consistently over consecutive 2-weeks after starting their maximum dose; had no CHR after receiving their maximum dose and had an increase in white blood count (WBC) defined as a doubling of the count from the lowest value to >20,000/mm^3 or an increase by > 50,000/mm^3 on two assessments performed at least 2 weeks apart; participant met criteria of accelerated or blast phase CML at any time; had a MCyR and subsequently no longer met the criteria for MCyR after starting their maximum dose; had a ≥ 30% absolute increase in the number of Ph+ metaphases. Although a related secondary endpoint was estimated duration of MCyR, medium duration of MCyR could not be estimated because the majority of participants with MCyR continued to respond, or could not be reliably estimated because of the large number of censored participants. Cytogenetic assessments were not done after the 24 month follow-up.|24 months|All imatinib-resistant participants who had achieved MCyR and experienced disease progression were summarized.||participants|||Number
170583|NCT00123474|Secondary|Time to CHR in Participants With CHR At 24 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with CHR were summarized.||Months||95% Confidence Interval|Median
170584|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 24 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.|24 months|Randomized imatinib-resistant participants with MCyR were summarized.||Months||95% Confidence Interval|Median
170585|NCT00123474|Secondary|Time to CHR in Participants With CHR at 6 Months Follow-Up|Time to CHR was defined as the time from the first dosing date until criteria are first met for the response. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to CHR response for responders and time to last hematologic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with CHR and available data were summarized.||Months||95% Confidence Interval|Median
170586|NCT00123474|Secondary|Time to MCyR in Participants With MCyR at 6 Months Follow-Up|Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders).|6 months|Randomized imatinib-resistant participants with MCyR and available data were summarized.||Months||95% Confidence Interval|Median
170587|NCT00123474|Secondary|Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up|A complete hematologic response (CHR) was obtained when all the following criteria were met: White Blood Cells (WBC) ≤ institutional upper limit of normal (ULN); Platelets < 450,000/mm³; No blasts or promyelocytes in peripheral blood (PB); < 5% myelocytes plus metamyelocytes in PB; Basophils in PB < 20%; No extramedullary involvement (including no splenomegaly or hepatomegaly). Hematologic responses were counted anytime following 14 days after the dosing start date.|6 months, 24 months|All randomized imatinib-resistant participants with available data were summarized.||percentage of participants||95% Confidence Interval|Number
170588|NCT00123474|Secondary|Percent of Participants With MCyR At or Prior to 24 Months Follow-Up|CyR was based on the number of Ph+ metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: CCyR: 0% Ph+ cells in metaphase in BM; PCyR: >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of CCyR or PCyR. Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|24 months|All randomized imatinib-resistant participants with available data were summarized.||percentage of Participants||95% Confidence Interval|Number
170589|NCT00123474|Primary|Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up|Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): >0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: >35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: >65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: >95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.|6 months|All randomized imatinib-resistant participants with available data were summarized.||percentage of Participants||95% Confidence Interval|Number
170591|NCT00123422|Primary|Exercise Endurance|Exercise endurance on a constant workrate treadmill test was measured at 14 weeks. The workload on the constant workrate treadmill test corresponded to the grade and speed that the participate had reached on a symptom-limited treadmill test when they reached 85% of their peak oxygen uptake value.|14 weeks|We used an intent-to treat analysis using the last value carried forward. All participants were included in the final analysis.||minutes||Standard Deviation|Mean
170592|NCT00123409|Secondary|Reduced Problems Related to Alcohol|The Short Inventory of Problmes was used to measure the number of alcohol related problems encountered in the prior 3 months. The scale has a minimum of 0 with lower as better. The max score is 15 with each problem rated as present or absent.|12 months|||# of alcohol problems||Standard Deviation|Mean
170593|NCT00123409|Primary|Reduced Alcohol Use|Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.|12 months|||Days drinking||Standard Deviation|Mean
170594|NCT00123162|Secondary|Improvement in Pain Severity Determined by Visual Analog Scale (VAS).|"The Visual Analog Scale (VAS) assesses pain intensity. The scale is 100 mm long; the extremes of the scale are to the left, no pain and to the right, worst pain I have ever felt. The VAS score is determined by measuring the distance (in mm) from the left side of the scale to the point that the patient marked. The score ranges from 0 to 100, with higher values indicating greater pain."|Each hour of the study (0, 1, 2, 3, 4).|||mm||Standard Deviation|Mean
170595|NCT00123162|Primary|The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo.|The Total Pain Relief (TOPAR) Scale rates the level of pain relief on a scale of 0=None, 1=Mild, 2=Moderate, 3=Excellent, 4=Complete. The TOPAR scale was completed each hour after administration of study drug for a total of 4 hours. The 4 hourly scores were summed for a final TOPAR4 score that ranged between 0 and 16, with higher values indicating greater pain relief over time. Missing TOPAR scores after the first hour were imputed using the last-observation-carried-forward approach.|Hours 1, 2, 3 and 4.|||units on a scale||Standard Deviation|Mean
170596|NCT00123123|Secondary|Clinical Pulmonary Infection Score (CPIS) at 48 Hours|"The CPIS score was calculated as follows: 1) Fever: 0 (36.5 to 38.4°C), 1 (38.5 to 39), 2 (<36.0 OR >39.0); 2) Leukocytosis: 0 (4000 to 11,000 white blood cells per mm3 of blood), 1 (11,000 to 17,000), 2 (>17,000); 3) New infiltrate:~0 = None, 1 = Patchy, 2 = Localized; 4) Secretions: 0 = None to minimal, 1 = moderate, 2 = large amount; and 5) PaO2/ FiO2: 0 = more than 330 and 2 = less than 330. Total scores for the subscales can range from 0-10, with lower scores indicating better outcome."|48 hours|||units on a scale||Standard Deviation|Mean
170597|NCT00123123|Primary|Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours|Samples were diluted and plated on sheep's blood agar (to isolate S. aureus), and MacConkey agar (for isolation of Gram-negative bacilli) and incubated for 72 hours at 37°C in 5% carbon dioxide. Plates were assessed for growth for the following target bacteria: S. aureus, P. aeruginosa, Acinetobacter species, and enteric organisms (Klebsiella pneumoniae, Serratia marcescens, Enterobacter species, Proteus mirabilis, Escherichia coli). Results of quantitative cultures were expressed as colony forming units (cfu) per ml of sample.|Every 48 hours until discharge|All tests were carried out using intent-to-treat analysis, with two-sided tests with a significance level of 0.05. Baseline comparisons between groups were made by analysis of variance (ANOVA) and/or the chi-squared test, as appropriate.||CFU/mL||Standard Deviation|Mean
170598|NCT00122980|Secondary|Growth and Development - Weight (Change From Baseline to Endpoint)||baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data||kg||Standard Deviation|Mean
170599|NCT00122980|Secondary|Growth and Development - Height (Change From Baseline to Endpoint)||Baseline to end of study participation (up to 136 weeks)|Intent-to-Treat with endpoint data||cm||Standard Deviation|Mean
170600|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)- Verbal Ability|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Higher scores mean better abilities/achievements. Scaled scores range from 0-100.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
170601|NCT00122980|Secondary|Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)-Excluding Verbal|This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Scaled scores range from 0-100. Higher scores mean better abilities/achievements.|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat. Because the study was terminated, it was not possible to schedule the full battery of neurological assessments on all subjects. Only subjects with both baseline and end of study assessments were included in the analysis.||units on a scale||Standard Deviation|Mean
170602|NCT00122980|Secondary|Barthel Index (Change From Baseline)|The Barthel Index is a measure of activities of daily living (ADL) and assesses the degree of disability in a particular participant. The index records indicators of independence in terms of the disability caused by impairments, such as those that may be sequelae of stroke. The index was used as a record of what the participant did, not as a record of what the participant could do. Barthel scores range from 0 to 100, with higher scores indicating greater independence in daily living activities (caring for oneself).|Baseline and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat||units on a scale||Standard Deviation|Mean
170603|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Child Report (Change From Baseline)|The PedsQLTM Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, midpoint (week 64), and study exit (up to 30 months of treatment)|Intent-to-Treat||units on a scale||Standard Deviation|Mean
170604|NCT00122980|Secondary|Pediatric Quality of Life (PedsQL) - Parent Report (Change From Baseline)|The PedsQL(TM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.|Baseline, mid-point (week 64), and study exit after up to 30-month treatment period (due to study termination)|Intent-to-Treat||units on a scale||Standard Deviation|Mean
170605|NCT00122980|Primary|Liver Iron Content (LIC) Change-from-baseline|LIC change-from-baseline is the second component of the composite primary endpoint. LIC was measured by quantitative liver biopsy at baseline and at 30 months or exit from the study.LIC values were transformed into Log10 values prior to computing the change from baseline.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|Intent-to-treat AND both baseline and 30-month post-treatment LICs.||mg ferritin/gram dry weight liver||Standard Deviation|Log Mean
170606|NCT00122980|Primary|Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period|Secondary stroke is the first component of the composite primary endpoint and considers the number of participants with recurrent secondary stroke events during 30 months of treatment. Stroke was defined as any clinical event with brain injury due to vascular disease. All neurological events underwent formal stroke adjudication.|Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)|The Intent-to-Treat population included all subjects who were randomized and who received any on-study treatment.||participants|||Number
170607|NCT00122954|Secondary|Quality of Life (SF-36)||3 months||||||
170608|NCT00122954|Primary|Fifty Percent Improvement in Montgomery Asberg Depression Rating Scale After 3 Months of Treatment Was Used as the Primary Outcome Measure as This Would be Considered a Clinically Significant Change in Depression|Montgomery Asberg Depression Rating Scale is a structured interview assessment of depression, designed to be especially sensitive to changes in patients’ depression symptoms after antidepressant therapy and is more oriented towards psychic rather than somatic symptoms of depression|3 months|The study was powered to enroll twenty six subjects (13/group), the number needed to see a difference in HDRS over 3 months. The MADRS has good validation with the HDRS and is more sensitive to emotional change than the HDRS.||percentage of subjects|||Number
170609|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
170610|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
170611|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection|Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
170612|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection|GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
170613|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
170614|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection|GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
170615|NCT00122681|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection|Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||Subjects|||Number
170616|NCT00122681|Secondary|Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection|GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.|At Month 7|The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
170617|NCT00122681|Secondary|Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|Titers were expressed as GMTs.|At month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.||titer||95% Confidence Interval|Geometric Mean
170618|NCT00122681|Secondary|Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)|"Seropositivity was defined as subjects with a titer equal to or greater than 40.~Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination."|At Month 0, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity which included subjects for whom immunogenicity data were available.||subjects|||Number
170620|NCT00122681|Secondary|HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)|"HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination.~HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL."|Month 0, 7, 12 and 24|Analyses was performed on the Total Vaccinated Cohort on subjects with available results.||subjects|||Number
170621|NCT00122681|Secondary|Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset|"Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).~GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA [seronegative (sero-) or seropositive (sero+)]."|At Months 6, 7, 12, 24, 36 and 48|The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.||EL.U/mL||95% Confidence Interval|Geometric Mean
170622|NCT00122681|Secondary|Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus|"Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.~Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)"|At Months 6, 7, 12, 24, 36 & 48|The analyses were performed on the ATP cohort for immunogenicity on evaluable subjects for whom immunogenicity data were available.||subjects|||Number
170623|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
170624|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
170625|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
170626|NCT00122681|Secondary|Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen|"Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||Subjects|||Number
170627|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12.||subjects|||Number
170635|NCT00122681|Secondary|Number of Subjects Reporting Medically Significant Conditions|Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||subjects|||Number
175308|NCT00078559|Secondary|Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||adverse events|||Number
170628|NCT00122681|Secondary|Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals).~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12||subjects|||Number
170629|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
170630|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.~HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12||subjects|||Number
170631|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types|"Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.~Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.~HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.||subjects|||Number
170632|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12||subjects|||Number
170633|NCT00122681|Secondary|Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18|"Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12||subjects|||Number
170634|NCT00122681|Secondary|Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus|Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||subjects|||Number
170636|NCT00122681|Secondary|Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the entire study (Month 0 to 48)|Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||Subjects|||Number
170806|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
170637|NCT00122681|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the entire study period (Month 0 to Month 48)|Analysis was performed on the Total Vaccinated Cohort. The data are presented stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus (by ELISA).||subjects|||Number
170638|NCT00122681|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30 days after any vaccination|Analysis was performed on the Safety Subset of the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.||subjects|||Number
170639|NCT00122681|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria.~Data are presented across the 3 doses."|Within 7 days after any vaccination|Analysis was performed on a safety subset of the Total vaccinated cohort, which included vaccinated subjects from certain sites. Data are presented for the total subset (total), then stratified subject HPV-16/18 DNA & serostatus at baseline: DNA positive (DNA+) or negative (DNA-), ELISA seropositive (sero+) or seronegative (sero-).||subjects|||Number
170640|NCT00122681|Secondary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen|"CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline"|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.||subjects|||Number
170641|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in subjects:~DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)~Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|at Month 48|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.||subjects|||Number
170642|NCT00122681|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)|"CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.~Detection was done in:~DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).~Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline."|Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3|Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.||subjects|||Number
170643|NCT00122460|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007|Safety population||participants|||Number
170644|NCT00122460|Secondary|Quality of Life Assessment (EORTC QLQ-C30) Social Functioning|Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23||scores on a scale||Standard Error|Least Squares Mean
170701|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|50 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170702|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|40 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170645|NCT00122460|Secondary|Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status|Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.|at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007|Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab+chemotherapy/chemotherapy alone): Baseline: 121/106; Cycle3:87/67; Month6:48/22||scores on a scale||Standard Error|Least Squares Mean
170646|NCT00122460|Secondary|Duration of Response|"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria."|time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||months||95% Confidence Interval|Median
170647|NCT00122460|Secondary|Time to Treatment Failure|"Time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 60 days of last tumor assessment).~Patients without event are censored on the date of last tumor assessment."|Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||months||95% Confidence Interval|Median
170648|NCT00122460|Secondary|Disease Control|The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||percentage of participants||95% Confidence Interval|Number
170649|NCT00122460|Secondary|Best Overall Response|The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments according to investigator (based on modified WHO criteria).|evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||percentage of participants||95% Confidence Interval|Number
170650|NCT00122460|Secondary|Progression-free Survival Time (PFS)|"Duration from randomization until radiological progression according to investigator (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment."|time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.||months||95% Confidence Interval|Median
170651|NCT00122460|Primary|Overall Survival Time (OS)|Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007|"Primary analysis on Intent to Treat (ITT) population (allocation to treatment groups as randomized).~Analysis performed after the required number of 340 deaths had been reported (expected effect: 36% increase in median survival time, power = 80%, alpha=5% (two-sided)). The Clinical cut-off date was 12 Mar 2007."||months||95% Confidence Interval|Median
170652|NCT00122447|Other Pre-specified|AIM 2: Difference in FMD (Measure of Endothelial Function)|"Comparison of FMD (measure of endothelial function) between NGT, IGT and diabetes at baseline. FMD is a surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression.~No analysis was conducted due to under-recruitment."|Cross-sectional||||||
170653|NCT00122447|Primary|AIM 1: Change in Flow Mediated Dilation (FMD) (%)|Surrogate measure of endothelial function defined as the percent change in dilation of the brachial artery after cuff compression of arm compared to before cuff compression|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing||percentage of arterial dilation change||Standard Deviation|Mean
170654|NCT00122447|Secondary|AIM 1: Change in hsCRP (High Sensitivity C-reactive Peptide) Level|Inflammatory marker|12 months of intervention|Based on the number of subjects who completed 12 months of intervention and testing||mg/L||Standard Error|Mean
170655|NCT00122382|Secondary|Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period|Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated in the DB period. n=Number of participants evaluated for this measure.||participants|||Number
170703|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|30 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170704|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|20 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170656|NCT00122382|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.|All treated participants in the Double-Blind period||participants|||Number
170657|NCT00122382|Secondary|Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)|Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12, Month 24|Analysis includes all treated participants in the open-label period originally randomized to abatacept. Analysis includes all participants with observed assessments collected at Baseline (Day 1), Day 365 (Month 12), and Day 729 (Month 24)||units on a scale||Standard Error|Mean
170658|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12|Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Month 12, Month 24|Number of Participants Analyzed=All treated participants in the open-label period. (Treatment groups represent treatment received in the double-blind period.) n=the number of subjects with observed data included in the analysis.||Participants|||Number
170659|NCT00122382|Secondary|Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24|Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 24|All treated participants in the open-label period. Treatment groups represent treatment received in the double-blind period.||Participants|||Number
170660|NCT00122382|Primary|Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL|Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All participants treated during the open-label period; n= number of participants evaluated for this measure.||participants|||Number
170661|NCT00122382|Primary|Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period|Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All Treated participants in the Open-label Period; n=number of participants evaluated for this measure.||participants|||Number
170662|NCT00122382|Primary|Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period|There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.|Open-Label Period (Month 12 to Month 24)|All participants treated during the Open-Label period.||Participants|||Number
170663|NCT00122382|Primary|Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants|The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.||number of patients/100 patient-years|||Number
170705|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|10 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170807|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).||mg/dL||Standard Error|Mean
170664|NCT00122382|Primary|Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants|The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.||Number of patients/100 patient-years|||Number
170665|NCT00122382|Primary|Incidence Rates of Autoimmune Disorders in ABA-Treated Participants|The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.|Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).|All subjects who received at least 1 dose of abatacept. Double-blind (DB) period: all treated in DB period; Open-label (OL) Period: all treated in OL period.||Number of participants/100 patient-years|||Number
170666|NCT00122382|Primary|Number of Participants With SAEs With an Outcome of Death During the Open-label Period|Any untoward medical occurrence (SAE) that resulted in death|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.||participants|||Number
170667|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.|Baseline, Month 24|All treated participants in the open-label period. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied. Treatment groups represent treatment received in the double-blind period.||units on a scale||Standard Deviation|Mean
170668|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Baseline, Month 24|All treated participants in the Open-label period. Treatment groups represent treatment received in the Double Blind Period.||participants|||Number
170669|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|Treated participants in the open-label period were evaluated for anti-abatacept or anti-CTLA4-T responses||participants|||Number
170670|NCT00122382|Primary|Number of Participants With Serious Adverse Events Reported During the Open-Label Period|SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.||participants|||Number
170671|NCT00122382|Primary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.|All subjects who received at least 1 dose of ABA in the open-label period were included in the safety analyses.||participants|||Number
170672|NCT00122382|Primary|Mean Change From Baseline in Radiographic Total Score to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.|Baseline, Month 12|The analysis was intent-to-treat. Because the analysis was change from baseline, only those with baseline and post-baseline were included. Linear extrapolation imputation was applied.||units on a scale||Standard Deviation|Mean
170837|NCT00121225|Secondary|Effect of Vorinostat on Serum Levels of VEGF and b-FGF||Baseline, day 8 and day 15||||||
170673|NCT00122382|Primary|Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12|Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.|Month 12|Intent to treat = all randomized and treated subjects. Those with missing data post-discontinuation were considered non-responders.||participants|||Number
170674|NCT00122382|Secondary|Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)|Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).|includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.|Treated participants in the double-blind period who were evaluated for anti-abatacept or anti-CTLA4-T responses||Participants|||Number
170675|NCT00122382|Secondary|Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value|Baseline, Month 12|Intention-to-Treat - linear extrapolation imputation. Analysis of change from baseline restricts subjects included in to the analysis to those with baseline and post-baseline.||units on a scale||Standard Deviation|Mean
170676|NCT00122382|Secondary|Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12|The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.||units on a scale||Standard Error|Mean
170677|NCT00122382|Secondary|Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12|Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.||participants|||Number
170678|NCT00122382|Secondary|Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12|DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.|Baseline, Month 12|Last Observation Carried Forward (LOCF) Intent to Treat population = all randomized and treated. As change from baseline analysis, only those with baseline and post-baseline included.||units in a scale||Standard Error|Mean
170679|NCT00122382|Secondary|Number of Participants With Major Clinical Response (MCR) at Month 12|MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.||participants|||Number
170680|NCT00122382|Secondary|Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12|ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].|Month 12|Intention-to-Treat=All randomized and treated; all missing data subsequent to discontinuation are considered non-responders.||participants|||Number
170706|NCT00122369|Secondary|Impact of Event Scale (IES-15)|"The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75.~≥26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy"|Patients were followed for up to 3 weeks after their biopsy until the time of their surgery|These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy.||Scores on a Scale||Standard Deviation|Mean
170681|NCT00122369|Primary|Time Trends of Pain Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy||logit slopes|||Number
170682|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|110 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170683|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|100 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170684|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|90 min|Patients remaining on procedure table. (Please note that the data in the hypnosis group encompass 4 data points since one patient did not indicate her anxiety level at that time point).||units on a scale||Inter-Quartile Range|Median
170685|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|80 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170686|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|70 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170687|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|60 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170688|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|50 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170689|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|40 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170690|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|30 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170691|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|20 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170692|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|10 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170693|NCT00122369|Primary|Pain Ratings at Specified Time Point During the Procedure|Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain|0 min|Intent to Treat; patients on procedure table. (Please note that the data in the empathy group encompass 81 data points since one patient did not indicate her pain level at that time point).||units on a scale||Inter-Quartile Range|Median
170694|NCT00122369|Primary|Time Trends of Anxiety Experience|Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.|0-110 min|Intent to Treat; patients undergoing breast biopsy||logit slopes|||Number
170695|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|110 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170696|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|100 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170697|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|90 min|Patients remaining on procedure table (please note that the data in the hypnosis group encompass only 4 patients since the 5th patient did not indicate her anxiety level at that time point)||units on a scale||Inter-Quartile Range|Median
170698|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|80 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170699|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|70 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170700|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety|60 min|Patients remaining on procedure table||units on a scale||Inter-Quartile Range|Median
170707|NCT00122369|Secondary|Salivary Cortisol Secretion|Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.|Patients were followed for the 5 days following their breast biopsy|Women learned their diagnosis between Day 1 and 6 (mean day 2.4). Analysis was truncated at day 5 when sufficient numbers of patients for meaningful analysis were available in each group: 16 in the “known malignant” group, 37 in the “known benign” group, and 73 in the “uncertain group” totaling 126 patients.||ln (microgram/dL)/hr||95% Confidence Interval|Mean
170708|NCT00122369|Primary|Anxiety Ratings at Specified Time Point During the Procedure|Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.|0 min|Intention to Treat; patients on procedure table||units on a scale||Inter-Quartile Range|Median
170709|NCT00122187|Primary|Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results|Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis||percent patients with GI consult+workup|||Number
170710|NCT00122187|Primary|Percent of Patients Receiving GI Consult for FOBT+ Results|Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results|6 months|Sites that completed the intervention and post-intervention data collection were included in the analysis||percent patients receiving GI consult|||Number
170711|NCT00122135|Primary|Presence of Discussions About End of Life Care Goals/Wishes|Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes|immediate|||participants|||Number
170712|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Post-treatment (2 weeks following last treatment session)|||units on a scale||Standard Deviation|Mean
170713|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|6-Month Follow Up|||units on a scale||Standard Deviation|Mean
170714|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|3-Month Follow Up|||units on a scale||Standard Deviation|Mean
170715|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Post-treatment (2 weeks following last treatment session)|||units on a scale||Standard Deviation|Mean
170716|NCT00122109|Primary|Novaco Anger Scale (NAS)|Anger disposition was assessed using the total scale score from the Novaco Anger Scale. This 60-item measure (range = 60 - 180) is a well validated self-report instrument designed to measure cognitive, arousal, and behavioral aspects of anger in both clinical and non-patient populations. Higher scores indicate more anger-related symptoms.|Baseline|||units on a scale||Standard Deviation|Mean
170717|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|6-month Follow Up|||units on a scale||Standard Deviation|Mean
170718|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|3-month Follow Up|||units on a scale||Standard Deviation|Mean
170719|NCT00122109|Secondary|PTSD Checklist-military Version (PCL-M)|Self report that measures severity of PTSD symptoms. The PCL-M measures the 17 cardinal symptoms of PTSD as described in the DSM-IV-TR. The scale ranges from 0 - 85 with higher scores indicating worse PTSD symptoms. PTSD symptoms were measured at baseline and post-treatment only.|Baseline|||units on a scale||Standard Deviation|Mean
170720|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Post-treatment (2 weeks following last treatment session)|||units on a scale||Standard Deviation|Mean
170754|NCT00121667|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
170721|NCT00122109|Primary|State-Trait Anger Inventory (STAXI-2) Anger Expression Index|Anger expression was measured using the STAXI-2’s 32-item Anger Expression Index (range 0 - 96). The STAXI-2 subscale have robust psychometric properties including high internal consistency, external validity, and construct validity. The Anger Expression Index provides a general measure of anger expression; assessing one's experience, expression and efforts to control anger. Higher scores indicate more problematic levels of anger and its expression.|Baseline|||units on a scale||Standard Deviation|Mean
170722|NCT00121836|Secondary|Number of Participants With Marked Laboratory Abnormalities|The secondary outcome measure was to evaluate the safety profile, including a summary of marked laboratory abnormalities in >= 5% of patients. n=number of participants with the laboratory measure,Number=number of participants with the abnormality. Laboratory values were flagged as Low(L) or High(H) if they were below the lower limit or above the upper limit of Roche standard reference range, respectively. Marked laboratory abnormalities (flagged as HH and LL) were defined as those values that were outside the Roche marked reference range and showed a clinically relevant change from baseline.|until progressive disease or for up to 3 years|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Participants|||Number
170723|NCT00121836|Secondary|Premature Withdrawal From Study Due to Adverse Events|The secondary outcome measure was to evaluate the safety profile, including a summary of premature withdrawals due to adverse events occurring in more than 1 patient in either study group, by system organ class.|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Participants|||Number
170724|NCT00121836|Secondary|Number of Subjects With Adverse Events|"The secondary outcome measure was to evaluate the safety profile, including a summary of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Intensity of AEs were graded according to NCI CTCAE version 3.0 on a 5-point scale: Grade 1=Mild Discomfort, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life Threatening/Disabling and Grade 5=Death. An SAE was defined as any experience that suggested a significant hazard,contraindication, side effect, or precaution."|Throughout study|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Participants|||Number
170725|NCT00121836|Primary|Overall Survival|Overall survival was defined as the time from date of first treatment dose (Day 1) to date of death, across the study phases regardless of the cause of death|approximately 505 days (Median Time to Death)|109 patients (pts) received study drug in the First Study Treatment Phase. 54 pts withdrew prematurely, and 54 pts proceeded to the Second Study Treatment Phase. All 54 pts who proceeded to the Second Study Treatment Phase withdrew during that phase. 1 pt continued treatment in the First Study Treatment Phase and completed 3 years of follow-up.||Days||95% Confidence Interval|Median
170726|NCT00121810|Secondary|Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)|"Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.||percent change||Standard Deviation|Mean
170727|NCT00121810|Secondary|Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization"|baseline 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.||percent change||Standard Deviation|Mean
170728|NCT00121810|Secondary|Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24|"Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.~percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization."|baseline, 6, 12, and 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.||percent change||Standard Deviation|Mean
170729|NCT00121810|Secondary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24|"A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.~percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|Baseline to 24 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 24: MMF+sirolimus = 115, MMF+CNI = 105.||percent change||Standard Deviation|Mean
170838|NCT00121225|Secondary|Incidence of p53 Allelic Variations (72R or 72P)|Compared using Fisher’s exact test with response.|Baseline||||||
170839|NCT00121225|Secondary|Effect of Vorinostat on HP1 and macroH2A Nuclear Foci|Compared with Fisher’s exact test to determine utility as biomarkers of response.|Baseline and day 15||||||
170730|NCT00121810|Primary|Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12|"The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.~percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent."|baseline to 12 months|Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 12: MMF+sirolimus = 120, MMF+CNI = 111.||percent change||Standard Deviation|Mean
170731|NCT00121719|Other Pre-specified|Pharmacodynamic (PD) Biomarkers of Lenvatinib in Peripheral Blood Mononuclear Cells (PBMCs) and Tumor Samples|Blood samples were collected for isolation of Peripheral Blood Mononuclear Cells (PBMCs) immediately prior to the first dose and at 3 and 24 hours following the first dose of lenvatinib. The same collection schedule was repeated following the administration of lenvatinib on Day 29 (Cycle 2 Day 1). For participants in the food-effect pilot study blood samples were collected pre-dose, plus 3 hour and 24 hours PD samples were collected on Day 15 or Day 22. These participants were not required to give PD samples on Cycle 2 Day 1. Tumor tissue samples were collected from participants with tumors accessible to biopsy (optional study). Tissue samples were formalin-fixed then paraffin embedded according to a standard protocol. Once preclinical studies have identified possible PD biomarkers for the biological effect of lenvatinib in vivo, the samples taken from participants in this study are planned to be analyzed. No data was provided at this time.|Blood: Cycle 1 Day 1, Day 15, or Day 22, Cycle 2 Day 1 Tumor tissue: Screening and after at least one 28-day Cycle of study treatment||||||
170732|NCT00121719|Secondary|Effect of Food on Time to Maximum Concentration (Tmax) of Lenvatinib|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1, Day 15, and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.||Hours||Full Range|Median
170733|NCT00121719|Secondary|Effect of Food on the Maximum Plasma Concentration (Cmax) of Lenvatinib|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed in nanograms/milliliter (ng/mL).|Cycle 1 Day 1, Day 15 and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.||ng/mL||Standard Deviation|Mean
170734|NCT00121719|Secondary|Effect of Food on the Area Under the Curve From Zero to 24 Hours (AUC(0-24))|Blood samples for PK analysis were collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib and 24 hours after the first dose of lenvatinib on Day 15 and Day 22 of Cycle 1. Blood samples were not collected on Day 29, except for the pre-dose sample. The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-24), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms*hours/milliliter (ng*hr/mL).|Cycle 1 Day 15 and Day 22|The Food Effect Population consisted of all subjects who agreed to participate in this part of the study, have received both the Day 15 and Day 22 doses, with PK sampling during 24 hours following those doses and consumed at least half (approximately) of the high fat breakfast when in the fed period.||ng*hr/mL||Standard Deviation|Mean
170735|NCT00121719|Secondary|Renal Clearance (CLr) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Renal clearance was calculated as: Ae(0-24)/AUC(0-24) where Ae(0-24) is amount of unchanged lenvatinib recovered in 24 hours. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CLr, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||L/hour||Standard Deviation|Mean
170736|NCT00121719|Secondary|Fraction of Unchanged Lenvatinib Excreted in the Urine (fe)|Urine aliquots were collected at 0 to 8, 8 to 16, and 16 to 24 hour intervals after administration of lenvatinib on Day 1 of Cycle 1 and Cycle 2, and then analyzed for the amount of lenvatinib using approved standardized methods. The samples were analyzed for the amount of lenvatinib in the urine using liquid chromatography-tandem mass spectrometry method of analysis. Urine PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of fe, which was then summarized as the mean and standard deviation for all participants and expressed in percentage of lenvatinib.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||Percentage of lenvatinib||Standard Deviation|Mean
170840|NCT00121225|Secondary|Time to Progression Assessed by RECIST||Up to 5 years||||||
170841|NCT00121225|Primary|Objective Response Rate Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)||Up to 5 years|||participants|||Number
170737|NCT00121719|Secondary|Apparent Volume of Distribution (Vz/F)|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The apparent volume of distribution gives information about the amount of lenvatinib distributed in body tissue rather than the blood/plasma. Vz/F for parent lenvatinib only was calculated as Dose /[( λz)*( AUC0-inf)]. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Vz/F, which was then summarized as the mean and standard deviation for all participants and expressed in liters (L).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||L||Standard Deviation|Mean
170738|NCT00121719|Secondary|Clearance Corrected for the Fraction of Lenvatinib Absorbed (CL/F)|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. CL/F is the clearance for parent lenvatinib only and was calculated as Dose/[AUC0-inf]. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CL/F, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||L/hr||Standard Deviation|Mean
170739|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC(0-24))|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The area under the plasma concentration-time curve from time 0 to 24 hours, was calculated using the linear trapezoidal rule. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-24), which was then summarized as the mean and standard deviation for all participants and expressed in ng*hr/mL.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||ng*hr/mL||Standard Deviation|Mean
170740|NCT00121719|Secondary|Area Under the Plasma Concentration Curve From Time 0 to Infinity (AUC(0-inf))|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) was calculated as AUC(0-t) + Ct / λz where Ct is the last measurable concentration. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms*hours/milliliter (ng*hr/mL).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||ng*hr/mL||Standard Deviation|Mean
170741|NCT00121719|Secondary|Apparent Plasma Half-life (t1/2) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. The apparent plasma half-life was calculated as t1/2 = 0.693/λz where the apparent first order elimination rate constant (λz) was determined by the slope of the terminal log-linear phase of the plasma concentration-time curve. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||Hours||Standard Deviation|Mean
170742|NCT00121719|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||Hours||Standard Deviation|Mean
170755|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
173544|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 1|Laboratory hematology white blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
170743|NCT00121719|Secondary|Maximum Plasma Concentration (Cmax) of Lenvatinib|Blood samples were drawn immediately prior to the first dose of study drug, and at 15 and 30 minutes and at 1, 1.5, 2, 2.5, 3, 5, 8, and 24 hours after the first dose of lenvatinib. For participants who were not enrolled in the food-effect part of the study, the collection of blood samples was repeated following administration of lenvatinib on Day 29 (Cycle 2 Day 1). The samples were analyzed for the amount of lenvatinib in the plasma using liquid chromatography-tandem mass spectrometry method of analysis. Plasma pharmacokinetics (PK) data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed as nanograms/milliliter (ng/mL).|Cycle 1 Day 1 (C1D1), Cycle 2 Day 1 (C2D1)|Pharmacokinetic population included all participants in the ITT/Safety population that had evaluable PK data in at least one treatment cycle.||ng/mL||Standard Deviation|Mean
170744|NCT00121719|Secondary|Best Overall Response (BOR)|BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of lenvatinib until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at 7 weeks or later after starting lenvatinib.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to approximately 4 years|Intent-to-treat population included all participants who received at least one dose of lenvatinib.||Percentage of participants|||Number
170745|NCT00121719|Secondary|Treatment-Related Adverse Events (All Grades) With an Overall Incidence Greater Than or Equal to 10%|Treatment-related AEs were untoward medical events that were considered by the investigator to be possibly or probably related to lenvatinib.|First date of study treatment to date of withdrawal from study or last dose of study treatment, up to approximately 4 years|Safety population (ITT population) included all participants who took at least one dose of lenvatinib.||Percentage of participants|||Number
170746|NCT00121719|Secondary|Dose-limiting Toxicities (DLTs)|A DLT was defined as any grade 3 or higher hematological or non-hematological toxicity directly related to lenvatinib, any repeated National Cancer Institute Common Toxicity Criteria (NCI CTC) grade 2 hematological or non-hematological toxicity considered to be directly related to lenvatinib and required dose reduction, or failure to administer greater than or equal to 75% of the planned dosage of lenvatinib during Cycle 1 as a result of treatment-related failure.|Cycle 1 (4 weeks) of each dose level|Intention to Treat (ITT)/Safety population included all subjects who received at least one dose of lenvatinib.||Participants|||Number
170747|NCT00121719|Secondary|Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs were collected from the signing of the informed consent form until the date the participant was withdrawn from the study. All AEs were graded on a 5-point scale according to the National Cancer Institute's Common Toxicity Criteria (NCI CTC) grading system, version 3.0. Safety was assessed using the occurrence of DLTs, AEs, SAEs, clinical laboratory test results, vital signs measurements, physical examination findings, and electrocardiograms (ECGs) readings. An AE was defined as any untoward medical occurrence in a participant administered lenvatinib and did not necessarily have a causal relationship to lenvatinib. An SAE was defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect. Treatment-related AEs and SAEs are AEs considered probably or possibly related to lenvatinib.|First date of study treatment to date of last dose of study treatment, up to approximately 4 years|Safety population (ITT population) included all participants who received at least one dose of lenvatinib.||Percentage of participants|||Number
170748|NCT00121719|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level at which no more than one out of six participants experienced dose-limiting toxicity (DLT). DLT was assessed during the first 4 weeks of therapy (Cycle 1) for dose escalation purposes. Participants enrolled into the MTD cohort were given the option to also participate in the food-effect pilot study. The food-effect pilot study was initiated once the MTD had been established.|Cycle 1 (4 weeks)|Intent-to-treat population included all participants who received at least one dose of lenvatinib.||mg|||Number
170749|NCT00121667|Other Pre-specified|Confirmed Hypoglycemia During the ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants||participants|||Number
170750|NCT00121667|Other Pre-specified|All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Treated participants||participants|||Number
170751|NCT00121667|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206,|Number of Participants Analyzed=Treated Participants; BL n=normal or abnormal ECG status at baseline of the cohort of participants with measure at given time point||participants|||Number
170752|NCT00121667|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||beats/min||Standard Error|Mean
170753|NCT00121667|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
170756|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
170757|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
170758|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
170759|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
170760|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^3 c/µL||Standard Error|Mean
170761|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^9 c/L||Standard Error|Mean
170762|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||10^6 c/µL||Standard Error|Mean
170763|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||percentage red blood cells||Standard Error|Mean
170764|NCT00121667|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||g/dL||Standard Error|Mean
170765|NCT00121667|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period||participants|||Number
170766|NCT00121667|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|All treated participants||participants|||Number
170767|NCT00121667|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).||mg*min/dL||Standard Error|Mean
170768|NCT00121667|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24||Week 24|Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
170769|NCT00121667|Secondary|Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized Participants with measurement at timepoint. Last Observation Carried Forward (LOCF).||mg/dL||Standard Error|Mean
170770|NCT00121667|Primary|Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24|Mean change from baseline is adjusted for baseline value.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24)||percentage of glycosylated hemoglobins||Standard Error|Mean
170771|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point||beats per minute||Standard Error|Mean
170772|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
175309|NCT00078559|Secondary|Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status||Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||adverse events|||Number
170774|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline||participants|||Number
170775|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants||participants|||Number
170776|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|Treated participants||participants|||Number
170777|NCT00121641|Other Pre-specified|Confirmed Hypoglycemia During ST + LT Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants||participants|||Number
170778|NCT00121641|Other Pre-specified|All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Treated participants||participants|||Number
170779|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period||participants|||Number
170780|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.|All treated participants||participants|||Number
170781|NCT00121641|Other Pre-specified|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period|The normality/abnormality of the ECG tracing was determined by the investigator.|Baseline, Weeks 12, 24, 76, 102, 154, 206|Treated participants; BL n=number of participants at baseline||participants|||Number
170782|NCT00121641|Other Pre-specified|Changes From Baseline in Heart Rate During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||beats per minute||Standard Error|Mean
170783|NCT00121641|Other Pre-specified|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
170784|NCT00121641|Other Pre-specified|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period||Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||mmHg||Standard Error|Mean
170785|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
170786|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
170787|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
170788|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
174399|NCT00090259|Primary|Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
170789|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
170790|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^3 c/µL||Standard Error|Mean
170791|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^9 c/L||Standard Error|Mean
170792|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||x 10^6 c/µL||Standard Error|Mean
170793|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||percentage red blood cells||Standard Error|Mean
170794|NCT00121641|Other Pre-specified|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period||Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Treated participants; n=number of treated participants with measurement at time point||g/dL||Standard Error|Mean
170795|NCT00121641|Other Pre-specified|Marked Laboratory Abnormalities - During ST + LT Treatment Period|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.|Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period||participants|||Number
170796|NCT00121641|Other Pre-specified|Overall Summary of Adverse Events During ST+LT Treatment Period|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.|AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.|All treated participants||participants|||Number
170797|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||kg/m^2||Standard Deviation|Mean
170798|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||kg||Standard Deviation|Mean
170799|NCT00121641|Other Pre-specified|Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||participants|||Number
170800|NCT00121641|Other Pre-specified|Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort|This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.|Baseline|||years||Standard Deviation|Mean
170801|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort||Baseline, Week 24|Open Label participants with measure at given time points, Last Observation Carried Forward (LOCF).||mg*min/dL||Standard Error|Mean
170802|NCT00121641|Primary|A1C Changes From Baseline at Week 24 - Open Label Cohort|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Open-label participants with both a baseline and a post-baseline (up to Week 24)||Percentage of glycosylated hemoglobins||Standard Error|Mean
170803|NCT00121641|Secondary|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort||Week 24|Open Label Participants with measurement at time point, Last Observation Carried Forward (LOCF)||percentage of participants|||Number
170804|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort||Baseline, Week 24|Open Label Subjects with Measurement at Timepoint; Last Observation Carried Forward (LOCF)||mg/dL||Standard Error|Mean
170805|NCT00121641|Secondary|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)||Baseline, Week 24|Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).||mg*min/dL||Standard Error|Mean
175453|NCT00076752|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|18 months|||participants|||Number
170808|NCT00121641|Primary|Hemoglobin A1c (A1C) Changes From Baseline at Week 24|To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.|Baseline, Week 24|Randomized participants with both a baseline and post-baseline value (up to Week 24).||Percentage of glycosylated hemoglobins||Standard Error|Mean
170809|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making B|This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||Units measured in seconds||Full Range|Median
170810|NCT00121485|Secondary|Neurocognitive Assessments, Trail Making A|This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||Units measured in seconds||Full Range|Median
170811|NCT00121485|Secondary|Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)|The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
170812|NCT00121485|Secondary|Neurocognitive Assessments, Boston Naming Test|Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
170813|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)|The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
170814|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)|The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
170815|NCT00121485|Secondary|Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)|The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
170816|NCT00121485|Secondary|Neurocognitive Assessments, Clock Drawing|Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score.|Baseline (1 month), 6 months|Patients enrolled at 12 representative study sites participated in the neurocognitive testing. These study sites were selected based on their historic implant rates to represent high, medium and low enrolling centers.||units on a scale||Full Range|Median
170817|NCT00121485|Secondary|Reoperations|The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons|Patients were followed until outcome or up to 2 years post-implant, whichever came first|||percentage of participants|||Number
170818|NCT00121485|Secondary|Functional Status (Patient Activity Score)|Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)||percentage of participants|||Number
170819|NCT00121485|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)||Distance (meters)||Standard Deviation|Mean
170820|NCT00121485|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|Baseline, Months 1, 6, 12|Primary Study Cohort (As Treated)||percentage of participants in each class|||Number
173545|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 12|Laboratory hematology red blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
170821|NCT00121485|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life.|Baseline, Months 1, 3, 6, 12|Primary Study Cohort (As Treated)||Units on a KCCQ score scale||Standard Deviation|Mean
170822|NCT00121485|Secondary|Minnesota Living With Heart Failure Questionnaire(MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.|Baseline, Months 1,3,6,12|Primary Study Cohort (As Treated)||Units on a MLWHF Score scale||Standard Deviation|Mean
170823|NCT00121485|Primary|Composite Endpoint|Survival at two (2) years free of stroke, or reoperation to repair or replace the device|Patients' status at 2 years post-implant|Primary Study Cohort (Intent to Treat)||percentage of participants||95% Confidence Interval|Number
170824|NCT00121472|Secondary|Post-transplant Survival|30 day and 1 year post transplant survival|30 days, 1 year|Patients (n=112) who recieved a cardiac transplant were followed at 30 day and 1 year post-transplant to determine if the device influenced post-transplant survival.||percentage of participants|||Number
170825|NCT00121472|Secondary|Reoperations|Additional surgery after the initial implant operation|continuous|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).||Number of Events|||Number
170826|NCT00121472|Secondary|Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|baseline to 6 months|Mean change from baseline in 6MWT distance at Month 1, 3, and 6. Only patients alive, capable and willing to perform test are included.||meters||Standard Error|Mean
170827|NCT00121472|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHF)|MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.|Baseline to 6 months|Patients alive and capable of performing the test at 6 months||units on a MLWHF Score scale||Standard Error|Mean
170828|NCT00121472|Secondary|New York Heart Association (NYHA) Classification|NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|baseline, 1 month, 3 months, 6 months|All patients who survived to interval are included.||units on NYHA scale||Full Range|Mean
170829|NCT00121472|Secondary|Kansas City Cardiomyopathy Questionaire (KCCQ)|KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.|baseline to 6 months|Patients alive and capable of performing the test at 6 months||Units on a KCCQ Score scale||Standard Error|Mean
170830|NCT00121472|Secondary|Clinical Reliability (Malfunctions/Failures)|Confirmed malfunctions/Serious Adverse Events|continuous|||Number of Serious Events|||Number
170831|NCT00121472|Primary|Survival|Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).|180 days|The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).||participants|||Number
170832|NCT00121238|Secondary|Mean Time to Progression of Prostate Cancer|Kaplan-Meier estimates of time to progression will be reported.|Up to 5 years|Patients were eligible if they had a histologic or cytologic diagnosis of prostate cancer with no evidence of metastatic disease or local progression on radiologic imaging and had 3 consecutive rising levels of prostate specific antigen (psa). Eligible patients who were treated on this trial were analyzed for survival||months||95% Confidence Interval|Mean
170833|NCT00121238|Secondary|Median Survival Time|6 of 13 patients were alive at five years. The Median survival time was calculated for all patients.|Up to 5 years|||months||95% Confidence Interval|Median
170834|NCT00121238|Secondary|The Number of Participants With at Least One Incident of Toxicity|Toxicity was evaluated by NCI-CTCAE (ver. 3) criteria in all 15 treated patients (16 patients were enrolled however one progressed prior to treatment) including the two ineligible patients.|Up to 5 years|All treated patients, including 2 patients who were deemed ineligible for the study's endpoints to measure efficacy.||participants|||Number
170835|NCT00121238|Secondary|Median PSA Slope Difference|Median PSA slope difference was calculated between baseline and 6 months.|Baseline to 6 months|||ng/mL/month||Inter-Quartile Range|Median
170836|NCT00121238|Primary|The Number of Patients With a PSA Decline of ≥50%|"To assess the rate of Prostate Specific Antigen response associated with EMD121974 therapy in patients with non-metastatic androgen-independent prostate cancer.~This measure defined as a drop in PSA of at least 50% from the final pre-treatment value."|Up to 5 years|Per protocol: of the 16 patients registered for this arm, 13 were analyzed. 1 patient lost eligibility due to disease progression, 2 others were censored from efficacy analysis because it was determined they were ineligible based on PSA requirements.||participants|||Number
170842|NCT00121199|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
170843|NCT00121199|Primary|Progression-free Survival at 2 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
170844|NCT00121199|Primary|Progression-free Survival at 1 Year|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-1 year|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
170845|NCT00121199|Secondary|Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years.|All patients who started treatment were included in the analysis||participants|||Number
170846|NCT00121186|Primary|Overall Survival|OS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration|||participants|||Number
170847|NCT00121186|Primary|Progression-free Survival|PFS rate at 1 year.|1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration|||participants|||Number
170848|NCT00121134|Primary|The Completion Rate of 1 Year of Bevacizumab Therapy for All Four Cohorts||1 year|||percentage of participants|||Number
170849|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170850|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170851|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
170852|NCT00120874|Secondary|Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency|"The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or bothered their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96."|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
170853|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). The higher the score the worse the outcome.|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170854|NCT00120874|Secondary|Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)|The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). Global rating was not analyzed for this study. The higher the score the worse the outcome.|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
173546|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 6|Laboratory hematology red blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
170855|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.~The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170856|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170857|NCT00120874|Primary|Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)|The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
170858|NCT00120874|Secondary|Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)|"The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.~The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)"|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
170859|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170860|NCT00120874|Secondary|Change From Baseline of the Mini-Mental State Examination (MMSE)|The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
170861|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170862|NCT00120874|Secondary|Change From Baseline of the Severe Impairment Battery (SIB)|The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
170863|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 52 weeks|||units on a scale||Standard Deviation|Mean
170864|NCT00120874|Primary|Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)|CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse|Baseline to 28 weeks|||units on a scale||Standard Deviation|Mean
170865|NCT00120627|Post-Hoc|Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text Revision|Hyper-arousal Subscale (Criterion D) assesses symptoms of difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance, and exaggerated startle response. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Scores are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment|||units on a scale||Standard Deviation|Mean
170866|NCT00120627|Post-Hoc|Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text Revision|Avoidance (Criterion C) Subscale assesses symptoms of feeling detached and estranged from others; markedly diminished interest in significant activities; efforts to avoid thoughts, feelings, or conversations associated with the trauma; and efforts to avoid activities, places, or people that arouse recollections of the trauma. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 56, higher scores indicating greater levels of symptoms.|Pre-treatment and Post-treatment|||units on a scale||Standard Deviation|Mean
170876|NCT00120523|Primary|Potential Effect on the Developing Immune System|number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.|throughout the 5-year study|Immune system function data analyses were performed on the immunology set (774 patients). Varicella titers were assessed for USA patients only (n= 104, n=108).||% of patients with positive ab titer|||Number
170867|NCT00120627|Post-Hoc|Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text Revision|Re-experiencing Subscale (Criterion B) assesses symptoms of persistent re-experiencing of the traumatic event. This may include recurrent, intrusive recollections of the traumatic event; recurring dreams of the event; acting or feeling as if the traumatic event were occuring; and intense psychological distress at exposure to internal or external cues that symbolize or represent the event. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.|Pre-treatment to Post-treatment|||units on a scale||Standard Deviation|Mean
170868|NCT00120627|Secondary|Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization|The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.|Pre-treatment and Post-treatment|||units on a scale||Standard Deviation|Mean
170869|NCT00120627|Primary|PTST Checklist (PCL) Civilian Version|"The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0=not at all to 5=extremely. Higher scores indicate greater severity and scores range from 17-85."|Pre-treatment and Post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
170870|NCT00120627|Secondary|Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities|Quality of Life Enjoyment & Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing data, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
170871|NCT00120627|Secondary|Mindfulness Attention Awareness Scale (MAAS)|The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.|Baseline, Post-Intervention|||units on a scale||Standard Deviation|Mean
170872|NCT00120627|Secondary|Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]|"FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of feeling peaceful, having meaning and purpose in life and finding comfort in faith or spiritual beliefs. Items are rated on a 5-point Likert scale: 0 = not at all and 4 = very much. Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being."|Pre- & Post-Intervention|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
170873|NCT00120627|Secondary|Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)|"Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include feeling calm and peaceful, having alot of energy, feeling downhearted and blue -- all rated on a frequency scale from 1= all of the time to 6=none of the time. Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) accomplishing less than you like and (2) not doing work or activies as carefully as usual (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing values; a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
170874|NCT00120627|Primary|Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR|"The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0=never to 4=daily or almost everyday. The items for intensity are rated from 0=none to 4=extreme. Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis.~The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms."|Pre-treatment and post-treatment|Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS for missing data; this is a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||units on a scale||Standard Deviation|Mean
170875|NCT00120523|Secondary|Vital Signs and Physical Examinations: Pulse|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.||bpm||Standard Deviation|Mean
170896|NCT00120042|Secondary|Post-Delivery Blood Loss|Blood loss was assessed by weighing of pads and sheets in addition to clot|3 years|||mls||Inter-Quartile Range|Median
170877|NCT00120523|Secondary|Vital Signs and Physical Examinations: Blood Pressure (BP)|Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patients who do not have baseline value are excluded from analysis.||mmHg||Standard Deviation|Mean
170878|NCT00120523|Secondary|Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)|"PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.~For the purposes of data presentation, a “Not True” response was coded a value of zero and a “True” a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient’s total score at the time point was set to missing."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication. Patients who do not have baseline value are excluded from the analysis.||units on a scale||Standard Deviation|Mean
170879|NCT00120523|Secondary|Body Surface Area Involved With Atopic Dermatitis|TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.||percentage of TBSA affected||Standard Deviation|Mean
170880|NCT00120523|Secondary|Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate|"IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.~Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success."|throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.||percentage of participants||95% Confidence Interval|Number
170881|NCT00120523|Primary|Growth Velocity (Weight)||throughout the 5-year study|Safety/intent-to-treat (ITT) - all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.||kg||Standard Deviation|Mean
170882|NCT00120523|Primary|Growth Velocity (Height)||throughout the 5-year study|Safety/intent-to-treat (ITT) – all randomized patients who received at least one application of study medication.Patient who do not have a baseline value are excluded from the analysis.||cm||Standard Deviation|Mean
170883|NCT00120523|Primary|Safety Assessed by Adverse Events|crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period|throughout the 5-year study|complete safety/ITT population of experimental and control||percentage of participants|||Number
170884|NCT00120406|Primary|Primary Patency|Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.|12 months|||Percentage of participants|Participants||Number
170885|NCT00120406|Primary|Event-free Survival Rate|"Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6.~Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted."|12 months|||Percentage of participants|||Number
170886|NCT00120289|Secondary|Cardiovascular Mortality||Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months.|Intention to treat||participants|||Number
170887|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months|Intention to treat||participants|||Number
170888|NCT00120289|Secondary|Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months|||participants|||Number
170889|NCT00120289|Primary|Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization||Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.|Intention-to-treat||participants|||Number
170890|NCT00120250|Secondary|Clinician-Administered PTSD Scale (CAPS)|"The CAPS is a highly detailed measure of the presence and severity of the DSM-IV PTSD criteria. The severity score was calculated by adding up the frequency score (scale 0 = none of the time to 4 = most or all of the time) and an intensity score (scale 0 = none to 4 = extreme), which can then be summed for all 17 symptom questions and/or for the three symptom clusters. Scores range from 0 to 136, where greater than or equal to 80 represents extreme PTSD symptomatology. In this case, the total score for all 17 symptom questions, which is also the sum of the three symptom clusters, is used."|Week 3|||units on a scale||Standard Deviation|Mean
170891|NCT00120250|Secondary|Total Sleep Time|Total Sleep Time was derived from a subject-completed daily sleep diary.|8 weeks|||Minutes||Standard Deviation|Mean
170892|NCT00120250|Secondary|Sleep Latency|Sleep Latency was derived from a subject-completed daily sleep diary.|8 weeks|||Minutes||Standard Deviation|Mean
170893|NCT00120250|Primary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.|8 weeks|||units on a scale||Standard Deviation|Mean
170894|NCT00120250|Primary|Short PTSD Rating Interview (SPRINT)|The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.|8 weeks|||units on a scale||Standard Deviation|Mean
170895|NCT00120042|Secondary|Endometrial Appearances Postpartum||3 years||||||
170898|NCT00119678|Secondary|OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept.|After the first dose of open-label period|Immunogenicity analysis population: participants who received abatacept and for whom baseline and at least one additional measurement during the open-label period were available.||participants|||Number
170899|NCT00119678|Secondary|OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent|Total exposure to glucocorticosteroid was measured by the total prednisone or prednisone equivalent AUC. Based on the recommendation of the Data Monitoring Committee, the open-label, long-term extension period was terminated by the sponsor, for failure to meet the primary outcome measure for the double-blind period and because of an increase in SAEs in the abatacept treatment group. As such, these data were not analyzed.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
170900|NCT00119678|Secondary|OL; Total Number of BILAG A Flares Each Participant Experienced|Total number of BILAG A flares in any organ system after steroid tapering = new BILAG A features in any organ system. Scores defined as follows: None: participants with no BILAG A flare; 1: participants with 1 BILAG A flare or participants who discontinued without a new BILAG A flare were imputed as having one event. 2: participants with 2 BILAG A flares; 3 or >3: participants with 3 or more BILAG A flares.Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
170901|NCT00119678|Secondary|OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline|SLICC/ACR damage index:measure of cumulative damage due to SLE.Damage=non-reversible change occurring since onset of lupus,ascertained by clinical assessment & present for =>6 months.Scores of SLICC/ACR index:1:single episode;2:repeated episodes at least 6 months apart.Change in score from baseline to 1 year presented as:no change,increase 1 (an increase in score of 1),increase >1 (an increase in score of >1).Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365) and on Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
170902|NCT00119678|Secondary|OL; Number of Participants With a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious lupus features;B:more moderate features;C:mild symptomatic features;D:prior activity with no current symptoms due to active lupus;E:an organ that has never been involved.BILAG scores based on degrees of change in clinical features (1=improving,2=staying the same,3=worsening,4=new).New SLE flare means new BILAG A/B features in any organ system.Based on the recommendation of the Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.|From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.|||||
170903|NCT00119678|Secondary|DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment|Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept.|From Day 1 to Day 365|Participants who received abatacept and for whom baseline and at least one additional measurement during double-blind period were available.||participants|||Number
170904|NCT00119678|Primary|OL; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, red blood cells (RBC), white blood cells (WBC): >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; Glomerular filtration rate (GFR): <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: all treated participants who entered the OL period and received at least 1 dose of study medication. Where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high(GFR) values and presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
170905|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for either low (cholesterol, triglycerides) or high (albumin) has been presented as 0. n = number of participants with evaluable results (each arm respectively)."||participants|||Number
170928|NCT00119262|Primary|Congestive Heart Failure Rate|Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.|assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry|223 treated patients||percentage of participants||95% Confidence Interval|Number
170906|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95x LLN or >1.05x ULN (if pre-Rx<LLN, then <0.95x pre-Rx or >ULN. If pre-Rx >ULN, then >1.05x pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9x LLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN; Calcium (total): <0.8xLLN or >1.2xULN (if pre-Rx <LLN, then <0.75x pre-Rx or >ULN. If pre-Rx >ULN, then >1.25x pre-Rx or <LLN.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||participants|||Number
170907|NCT00119678|Primary|OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for low values (ALP, AST, ALT, GGT, bilirubin, BUN, creatinine) and has been presented as 0."||participants|||Number
170908|NCT00119678|Primary|OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MMAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where not evaluable was recorded for either low(monocytes, basophils, eosinophils) or high(neutrophils) has been presented as 0."||participants|||Number
170909|NCT00119678|Primary|OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* lower limit of normal (LLN) or >1.5* upper limit of normal (ULN) (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|"As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where not evaluable was recorded for high values (hemoglobin, hematocrit, erythrocytes) and has been presented as 0. n = number of participants with evaluable results (each arm respectively)."||participants|||Number
170910|NCT00119678|Primary|OL; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs of particular importance were associated with the use of immunomodulatory agents. Number of participants with infections, malignant Neoplasms, pre-specified autoimmune disorders, acute-infusional AEs and peri-infusional AEs were recorded.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||participants|||Number
170911|NCT00119678|Primary|Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs or SAEs: events with a relationship to the study therapy of certain; probable; possible; or missing.|From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period|As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.||participants|||Number
170912|NCT00119678|Secondary|DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings|Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). Significant vital signs and physical examination findings are reported in the AE tables. Symptoms related to lupus were collected in British Isles Lupus Assessment Group (BILAG) assessments."|||||
170929|NCT00119158|Secondary|Change From Baseline in Patients' Self Assessment of Disease Severity (PSA) of Target Areas|"The patient or caregiver assessment of eczema severity (PSA) was recorded daily in a diary using a 0–4 scale similar to that of the IGA.(0 = clear,~1 = almost clear, 2 = mild disease, 3 = moderate disease,4 = severe disease).~Difference in value of PSA from baseline to end of study"|30 days||||||
170913|NCT00119678|Secondary|DB; Number of Participants With MAs in Urinalysis|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, RBC, WBC: >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* pre-Rx, or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; GFR: <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low (protein, glucose, blood, leukocyte esterase, RBC, WBC) or high (GFR) values has been presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
170914|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dl or >220 mg/dl; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low or high values (albumin, cholesterol, triglycerides) has been presented as 0.n=number of participants with evaluable results (each arm respectively)."||participants|||Number
170915|NCT00119678|Secondary|DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)|MAs are laboratory measurements marked as abnormal as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95* LLN or >1.05* ULN (if pre-Rx <LLN, then <0.95* pre-Rx or >ULN. If pre-Rx >ULN, then >1.05* pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9* LLN or >1.1* ULN (if pre-Rx <LLN, then <0.9* pre-Rx or >ULN. If pre-Rx >ULN, then >1.1* pre-Rx or <LLN; Calcium (total): <0.8* LLN or >1.2* ULN (if pre-Rx <LLN, then <0.75* pre-Rx or >ULN. If pre-Rx >ULN, then >1.25* pre-Rx or <LLN.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).n=number of participants with evaluable results (each arm respectively)."||participants|||Number
170916|NCT00119678|Secondary|DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for low values (all parameters) and has been presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
170917|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for either low(monocytes, basophils and eosinophils) or high values(neutrophils)has been presented as 0.n=number of participants with evaluable results (each arm respectively)."||participants|||Number
170918|NCT00119678|Secondary|DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count|MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* LLN or >1.5* ULN (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated) where not evaluable was recorded for high values (hemoglobin, hematocrit and erythrocytes)has been presented as 0. n=number of participants with evaluable results (each arm respectively)."||participants|||Number
170930|NCT00119158|Secondary|The Percentage of Target Areas Reaching a m-EASI (Modifed-Eczema Area Severity Index) Score of 2 or Less|"The EASI is a measure of Atopic Dermatitis (AD) severity. A m-EASI score (0–12) was also calculated as the sum of severity (0 = mild to 3 = severe) for four separate AD symptoms: erythema, infiltration ⁄population, excoriation and lichenification.~The percentage of participants whose eczema reaches almost clear"|up to one week||||||
170931|NCT00119158|Secondary|The Percentage of Target Areas Improved (i.e., Decrease in Localized Investigator Global Assessmet (l-IGA) Score From Baseline)|"The percentage of eczema areas that show improvement in l-IGA score.~The l-IGA were graded on a scale of 0–4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease)."|up to 15 days||||||
170919|NCT00119678|Secondary|DB; Number of Participants With Significant AEs of Special Interest|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of special interest were associated with the use of immunomodulatory agents. Number of participants with infections, malignant neoplasms, pre-specified autoimmune disorders, acute infusional AEs and peri-infusional AEs were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated).Participants grouped for randomized treatments, except where different treatment taken for entire double-blind period (which will instead be presented by first treatment actually received)."||participants|||Number
170920|NCT00119678|Secondary|DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs: events with a certain; probable; possible; or missing relationship to the study therapy. Participants who discontinued the study due to an AE were recorded.|Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier|"All participants given study drug during the double-blind period (As Treated). The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match."||participants|||Number
170921|NCT00119678|Secondary|DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.|From start of study drug treatment to Day 365|All randomized and treated participants who were available for analysis, grouped by the treatment randomized to (ITT).||participants|||Number
170922|NCT00119678|Secondary|DB; Median Number of Days to the First Occurrence of a New SLE Flare|Elapsed days between start of corticosteroid taper & first day of flare.Scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of corticosteroid taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period|All randomized and treated participants, grouped by the treatment randomized to (ITT).||Days||95% Confidence Interval|Median
170923|NCT00119678|Secondary|DB; Total Number of New SLE Flares Each Participant Experienced|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (ITT).||Participants|||Number
170924|NCT00119678|Secondary|DB; Number of Participants With a New SLE Flare During the Initial 6 Months|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to 6 months.|All randomized and treated participants, grouped by the treatment randomized to (ITT).||Participants|||Number
170925|NCT00119678|Primary|Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare|SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG ‘A’ or ‘B’ event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).|From start of corticosteroid taper to Day 365|All randomized and treated participants, grouped by the treatment randomized to (Intent to Treat [ITT]). Participants who were inception treatment failures were treated as having 1 new flare; participants who discontinued early without any new flares were treated as having 1 new flare.||Participants|||Number
170926|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post bevacizumab (the end of treatment). 158 patients who were treated and had baseline and end of treatment LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment|||percentage of participants||95% Confidence Interval|Number
170927|NCT00119262|Secondary|Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)|The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post doxorubicin and cyclophosphamide (AC) Day 1 Cycle 5 (DIC5). 207 patients who were treated and had baseline and DIC5 LVEF values were included in the analysis.|assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment|Patients who were treated and had baseline and DIC5 LVEF values||percentage of participants||95% Confidence Interval|Number
170932|NCT00119158|Secondary|The Percentage of Target Areas Reaching a l-IGA (Localized Investigator Global Assessment (l-IGA) or 0 or 1)|The Investigator Global Assessment (IGA) and l-IGA were graded on a scale of 0–4 (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe). The percentage of eczema lesions from the total population that reach almost clear|up to 15 days||||||
170933|NCT00119158|Secondary|The Time to the First Day When m-EASI is Scored by the Investigator as 2 or Less|Time to partial clearance of the localized eczema lesion assessed by the investigator is measured in days|up to one week||||||
170934|NCT00119158|Secondary|The Time to Clearance of the Disease|The time to clearance of eczema measured in days|assessed up to 30 days following drug application|||days||Standard Error|Mean
170935|NCT00119158|Primary|Change From Baseline in the m-EASI (Eczema Area Severity Index) Score.|"Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification.~Total score 0-12"|up to 15 days|Analysis was per protocol, last observation carried forward||units of a 0-12 scale||Standard Deviation|Mean
170936|NCT00119041|Primary|A1c|Hemoglobin A1c is a measure of glycemic control|baseline and 18 months|||percentage of Hb that is glycosylated||Full Range|Mean
170937|NCT00119041|Secondary|Patient Satisfaction|Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.|Base line and at18 months.|The number subjects was determined on the size of the CBOC.||units on a scale||Full Range|Mean
170938|NCT00119015|Secondary|Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
170939|NCT00119015|Secondary|Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
170940|NCT00119015|Secondary|Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
170941|NCT00119015|Secondary|Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.~The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
170942|NCT00119015|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|"Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24.~The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.~The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.~A negative value indicates an improvement in symptoms."|Baseline and 2 weeks|||units on a scale||Full Range|Median
170955|NCT00118898|Secondary|Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
170943|NCT00118911|Secondary|Maintenance of Gains in CBT Condition|maintenance of gains in CBT condition for those who responded or partially responded as measured by the ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|12 month follow-up (12 months after baseline assessment)|||units on a scale of symptom severity||Standard Deviation|Mean
170944|NCT00118911|Primary|Post-treatment ADHD Symptoms|ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity.|post-treatment (after receiving 12 sessions of treatment)|Analysis was based on intent to treat. We used mixed-effect modeling which automatically imputes data using the slope up to the point of discontinuation.||units on a scale of symptom severity||Standard Deviation|Mean
170945|NCT00118898|Secondary|Change in Fasting Triglyceride Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
170946|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Regimen Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||percentage of participants||95% Confidence Interval|Number
170947|NCT00118898|Other Pre-specified|Number of Participants With Regimen Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||participants|||Number
170948|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Treatment Modification|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|At week 48 and 96|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||percentage of participants||95% Confidence Interval|Number
170949|NCT00118898|Other Pre-specified|Number of Participants With Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||participants|||Number
170950|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|At week 48 and 96|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.||percentage of participants||95% Confidence Interval|Number
170951|NCT00118898|Other Pre-specified|Number of Participants With a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.|Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.||participants|||Number
170952|NCT00118898|Primary|Time From Treatment Dispensation to Treatment Modification|Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||Weeks||95% Confidence Interval|Number
170953|NCT00118898|Other Pre-specified|Cumulative Probability of Not Experiencing Virologic Failure|Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|At week 48 and 96|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||percentage of participants||95% Confidence Interval|Number
170954|NCT00118898|Primary|Time From Treatment Dispensation to a Grade 3/4 Safety Event|Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.|As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.||Weeks||95% Confidence Interval|Number
174942|NCT00085293|Secondary|Change in Fludeoxyglucose (FDG) Uptake Measured by Positron Emission Tomography (PET) in Metastatic Tumor Sites Before and After DNA-methyltransferase Inhibitor Therapy (Optional)||Baseline to 3 weeks||||||
170956|NCT00118898|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
170957|NCT00118898|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. The protocol did not require that samples be collected fasting.|At Weeks 48 and 96|Intention to treat: All participants with fasting lipids data were included, complete-case approach.||mg/dL||Inter-Quartile Range|Median
170958|NCT00118898|Secondary|Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.|"AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.~http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm"|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||Participants|||Number
170959|NCT00118898|Secondary|Number of Participants With Virologic Failure and Emergence of Major Resistance|Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.||participants|||Number
170960|NCT00118898|Secondary|Change in CD4 Count (Cells/mm3) From Baseline|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).|At Weeks 48 and 96|Intention to treat: All participants with CD4 data were included, complete-case approach.||Cells/mm3||Inter-Quartile Range|Median
170961|NCT00118898|Secondary|Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.||Participants|||Number
170962|NCT00118898|Secondary|The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||At Weeks 48 and 96|Intention to treat: All participants with RNA data were included, complete-case approach.||Participants|||Number
170963|NCT00118898|Secondary|Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.||Weeks||95% Confidence Interval|Number
170964|NCT00118898|Other Pre-specified|Number of Participants With Virologic Failure|Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.|Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||participants|||Number
170965|NCT00118898|Other Pre-specified|Amount of Study Follow-up|Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.|Follow-up time was variable, median follow-up was 138 weeks|Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.||Weeks||Inter-Quartile Range|Median
170966|NCT00118898|Primary|Time From Randomization to Virologic Failure|Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.|Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details|Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.||Weeks||95% Confidence Interval|Number
170967|NCT00118755|Secondary|Duration of Overall Clinical Response (CR or PR)|Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.|Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days|Intent-to-treat population||Days to event||95% Confidence Interval|Median
170968|NCT00118755|Secondary|Best Overall Clinical Response|"Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient’s overall best response was complete response (CR), partial response (PR) (CR and PR considered responders), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met."|Through follow-up phase: Approximate Median of 318 days|Intent-to-treat population||Patients|||Number
170969|NCT00118755|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death, for any cause.|Time to death (through follow-up phase): Approximate Median of 718 days|Intent-to-treat population||Days||95% Confidence Interval|Median
170970|NCT00118755|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).|Time to disease progression or death (through follow-up phase)|Intent-to-treat population||Days||95% Confidence Interval|Median
170971|NCT00118742|Secondary|Change From Baseline in Creatinine Clearance|Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation|6, 12, and 24 months posttransplantation|intent-to-treat population||Percent change in creatinine CL (mL/min)||Standard Deviation|Mean
170972|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|24 months posttransplant|intent-to-treat population||Mean percent change in GFR (mL/min)||Standard Deviation|Mean
170973|NCT00118742|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant|Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|6 months posttransplant|intent-to-treat population||Percent change in GFR (mL/min)||Standard Deviation|Mean
170974|NCT00118742|Primary|Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant|Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.|12 months posttransplant|intent-to-treat population||Percent change in GFR (mL/min)||Standard Deviation|Mean
170975|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months|||participants||95% Confidence Interval|Number
170976|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months|||participants||95% Confidence Interval|Number
170977|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months|||participants||95% Confidence Interval|Number
170978|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months|||participants||95% Confidence Interval|Number
170979|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months|||participants||95% Confidence Interval|Number
171003|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
170980|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months|||participants||95% Confidence Interval|Number
170981|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months|||participants||95% Confidence Interval|Number
170982|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months|||participants||95% Confidence Interval|Number
170983|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months|||participants||95% Confidence Interval|Number
170984|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months|||participants||95% Confidence Interval|Number
170985|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months|||participants||95% Confidence Interval|Number
170986|NCT00118534|Secondary|30-day Point Prevalence Abstinence – Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months|||participants||95% Confidence Interval|Number
170987|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|18 months|||participants||95% Confidence Interval|Number
170988|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|15 months|||participants||95% Confidence Interval|Number
170989|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|12 months|||participants||95% Confidence Interval|Number
171004|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months|||units on a scale||95% Confidence Interval|Mean
171005|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months|||units on a scale||95% Confidence Interval|Mean
170990|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|9 months|||participants||95% Confidence Interval|Number
170991|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|6 months|||participants||95% Confidence Interval|Number
170992|NCT00118534|Secondary|7-day Point Prevalence Abstinence – Bio-Verified|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.|3 months|||participants||95% Confidence Interval|Number
170993|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|18 months|||participants||95% Confidence Interval|Number
170994|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|15 months|||participants||95% Confidence Interval|Number
170995|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|12 months|||participants||90% Confidence Interval|Number
170996|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|9 months|||participants||95% Confidence Interval|Number
170997|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|6 months|||participants||95% Confidence Interval|Number
170998|NCT00118534|Secondary|7-day Point Prevalence Abstinence - Self Reported|Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.|3 months|||participants||95% Confidence Interval|Number
170999|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.|Baseline and 18 months|||units on a scale||95% Confidence Interval|Mean
171000|NCT00118534|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months|||units on a scale||95% Confidence Interval|Mean
171001|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
171002|NCT00118534|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months|||units on a scale||95% Confidence Interval|Mean
171006|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.|Baseline and 15 months|||units on a scale||95% Confidence Interval|Mean
171007|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.|Baseline and 12 months|||units on a scale||95% Confidence Interval|Mean
171008|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.|Baseline and 9 months|||units on a scale||95% Confidence Interval|Mean
171009|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.|Baseline and 6 months|||units on a scale||95% Confidence Interval|Mean
171010|NCT00118534|Secondary|PTSD Checklist|Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.|Baseline and 3 months|||units on a scale||95% Confidence Interval|Mean
171011|NCT00118534|Secondary|Clinician Administered PTSD Scale (CAPS)|"Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was CAPS at 18 months. The range is 0-136; five rationally derived severity score ranges for interpreting CAPS total score have been proposed and are as follows: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology. A rationally derived 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. The above severity ranges and 15-point marker are preliminary (Frank W. Weathers et. al., Clinician-administered PTSD Scale: A Review of the First Ten Years of Research, Depression and Anxiety 13: 132-156 (2001)). The results are reported in mean change from baseline."|Baseline and 18 months|||Units on a scale||95% Confidence Interval|Mean
171012|NCT00118534|Secondary|Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months|A secondary outcome was self-reported 1-year prolonged abstinence between 6 and 18 months post-randomization. Prolonged abstinence excluded tobacco use prior to 6 months post-randomization to allow for initial treatment episode completion and recovery from early relapses. Prolonged abstinence defined non-abstinence as: 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks.|between 6 and 18 months|||participants|||Number
171013|NCT00118534|Primary|Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization|The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine <100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.|between 6 and 18 months|||participants|||Number
171014|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 2 (Week 12) and Phase 3 (Week 24)|||Points on a scale||Standard Deviation|Mean
171015|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured after Phase 1 (Week 6) and Phase 2 (Week 12)|||Points on a scale||Standard Deviation|Mean
171016|NCT00118417|Primary|Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)|This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.|Measured at baseline and after Phase 1 (6 weeks)|Analyses in each study phase were for a modified intent to treat (ITT) sample, defined as all participants who had at least one on-treatment assessment during that phase.||Points on a scale||Standard Deviation|Mean
171017|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)."|Measured at month 32|Intention to treat analysis||% patients who relapsed/recurred|||Number
171044|NCT00118365|Primary|Detection of Any Adenoma at the End of the Study|Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done.||participants|||Number
171018|NCT00118404|Primary|Depressive Relapse/Recurrence or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring MDD) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~Relapse/recurrence rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 20|Intention to treat analysis||% patients who relapsed/recurred|||Number
171019|NCT00118404|Primary|Depressive Relapse or MDD|"Longitudinal Interval Follow-up Evaluation - Psychiatric Status Rating (LIFE-PSR) of 5 or more (on a scale from 1 to 6 measuring major depressive disorder) for 2 consecutive weeks according to evaluator blinded to randomized assignment~LIFE-PSR Scale:~= No residual symptoms, no current evidence of the disorder.~= Mild symptoms~= Considerably less psychopathology than full criteria with no more than moderate impairment~= Does not meet full criteria but has major symptoms of impairment~= Meets criteria without extreme impairment in functioning~= Meets criteria with extreme impairment in functioning~The relapse rate was estimated using Kaplan-Meier estimates (Kaplan, Meier J Am Stat, 1958, pp.457-481)"|Measured at month 8|Intention to treat analysis||% patients who relapsed|||Number
171020|NCT00118378|Secondary|HIV RNA Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Log10 copies/mL||Standard Deviation|Mean
171021|NCT00118378|Secondary|CD4 Cell Count|CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.||Cells/mcL||Standard Deviation|Mean
171022|NCT00118378|Primary|Role Function Scale Outcome|The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.||units on a scale||Standard Deviation|Mean
171023|NCT00118378|Primary|Fatigue Severity Scale (FSS)|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.|Measured at baseline and Week 4|The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.||units on a scale||Standard Deviation|Mean
171024|NCT00118365|Secondary|Biomarker in Adenoma: Bcl-2|bcl-2 is the anti-apoptotic protein BCL2|At the end of the study, up to 3 years|The analysis cohort is based on the participants whose data are available.||Adenoma|Participants||Number
171025|NCT00118365|Secondary|Biomarker in Adenoma - p53|"Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates.~Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene."|At the end of the study|The analysis cohort is based on the participants whose data are available.||percentage of cells that are positive||95% Confidence Interval|Mean
171026|NCT00118365|Secondary|Biomarker in Adenoma: Sialyl-TN (B72.3)|sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.||Adenoma|Participants||Number
171027|NCT00118365|Secondary|Biomarker in Adenoma: CEA|carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.|At the end of the study|The analysis cohort is based on the participants whose data are available.||Adenoma|Participants||Number
171028|NCT00118365|Secondary|Biomarker in Adenoma - Ki-67|Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates|At the end of the study|The analysis cohort is based on the participants whose data are available.||percentage of cells that are positive||95% Confidence Interval|Mean
171029|NCT00118365|Secondary|Biomarker in Adenoma: Apoptosis|Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.|At the end of the study|The analysis cohort is based on the participants whose data are available.||adenoma|Participants||Number
171030|NCT00118365|Secondary|Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171031|NCT00118365|Secondary|At the End of the Study - Spermine Response by ODC Genotype|"Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171032|NCT00118365|Secondary|At the End of the Study - Spermidine Response by ODC Genotype|"Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171033|NCT00118365|Secondary|At the End of the Study - Putrescine Response by ODC Genotype|"Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete."|At the end of the study|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171034|NCT00118365|Secondary|Baseline Spermine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.||nmol/mg protein||Full Range|Median
171035|NCT00118365|Secondary|Baseline Spermidine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.||nmol/mg protein||Full Range|Median
171036|NCT00118365|Secondary|Baseline Putrescine by ODC Genotype|ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.|Baseline|The analysis cohort is based on the participants whose data are available and complete.||nmol/mg protein||Full Range|Median
171037|NCT00118365|Secondary|Adverse Events With a Grade of 3 and Above|"Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other.~Per protocol, not all grade 3 events are considered as serious events."|Up to 36 months|||participants|||Number
171038|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment|Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171039|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment|Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171040|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment|PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.|Up to 36 months|The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171041|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment|"The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort.~In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset.~The analysis cohort is based on the participants whose data are available and complete."|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171042|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment|The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.|Up 36 months|In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.||participants|||Number
171043|NCT00118365|Secondary|Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.|Up to 36 months|This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.||participants|||Number
171045|NCT00118248|Secondary|Toxicity|Defined as the number of participants reporting grade 3 or higher adverse events that are classified as either possibly, probably, or definitely related to study treatment. Determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles)|All participants were evaluable for this endpoint.||participants|||Number
171046|NCT00118248|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the Kaplan-Meier method.|Every 3 months until progression, and then every 6 months up to 3 years|All patients were evaluable for this endpoint.||years||95% Confidence Interval|Median
171047|NCT00118248|Secondary|Progression-Free Survival|Defined as the time from registration to the date of progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free. Estimated using the Kaplan-Meier method.|Every 3 months for up to 3 years|All participants were evaluable for this endpoint.||months||95% Confidence Interval|Median
171048|NCT00118248|Secondary|Overall Response|"The number of responses were categorized and summarized independently within each of the patient groups. Participants were evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.0.~Complete Response (CR): Disappearance of all lesions.~Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Baseline, every 3 courses, and at the end of treatment study|All participants were evaluated for response.||participants|||Number
171049|NCT00118248|Primary|Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)|"The one-year treatment failure free rate is 100% times the proportion of eligible patients who remain on treatment and are progression-free at least one year after treatment start. A 90% confidence interval for the one year treatment failure free rate was constructed using the properties of the binomial confidence interval.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are not classified as having a progression are termed progression-free."|1 year|All patients were evaluable for this endpoint in this group.||percentage of participants||90% Confidence Interval|Number
171050|NCT00118157|Secondary|Changes in Phosphorylation in Tumor Tissue of Epidermal Growth Factor Receptor (EGFR), HER2, AKT Kinase, MAPK, ER-Ser118, and ER-SER167||Baseline and at 21 days||||||
171051|NCT00118157|Primary|Tumor Response Rate (Complete and Partial) Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)||4 weeks|||participants||95% Confidence Interval|Number
171052|NCT00118144|Secondary|Overall Survival|Overall Suvival using the product-limit method of Kaplan and Meier.|Up to 5 years|||Months||95% Confidence Interval|Mean
171053|NCT00118144|Secondary|Progression-free Survival|Progression Free Survival using the product-limit method of Kaplan and Meier|Up to 5 years|||Months||95% Confidence Interval|Median
171054|NCT00118144|Primary|Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.|A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.|Up to 5 years|||percentage of responders|||Number
171055|NCT00118131|Secondary|Median Survival Time||10 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||months||95% Confidence Interval|Median
171056|NCT00118131|Secondary|1-year Survival Rate||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||1-year survival rate (percentage)|||Number
171057|NCT00118131|Secondary|Time to Progressive Disease||8 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||months||95% Confidence Interval|Median
171058|NCT00118131|Primary|Overall Tumor Response Rate|Patients experiencing complete or partial response|7 years|Analysis was performed on the first 47 patients only as it was too early to collect data for the last 2 patients.||Response rate (percentage)|||Number
171059|NCT00118053|Secondary|Pathologic and Molecular Markers for Predicting Efficacy||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
171060|NCT00118053|Secondary|Disease-free Survival||10 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
171061|NCT00118053|Secondary|Pathological Complete Response||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
171062|NCT00118053|Primary|Antitumor Activity as Measured by Response Rate||5 years|Study was terminated early and insufficient data were collected to evaluate this outcome measure.|||||
171063|NCT00118040|Secondary|pMAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, pMAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of pMAP Kinase strength signa|||Number
171064|NCT00118040|Secondary|MAP Kinase in Tumor Tissue|"Detecting the signal of the biomarker, MAP Kinase, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of MAP Kinase strength signal|||Number
171196|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Triglycerides (TG)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171065|NCT00118040|Secondary|pAKT in Tumor Tissue|"Detecting the signal of the biomarker, pAKT, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of pAKT strength signal|||Number
171066|NCT00118040|Secondary|AKT in Tumor Tissue|"Detecting the signal of the biomarker, AKT, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of AKT strength signal|||Number
171067|NCT00118040|Secondary|COX2 in Tumor Tissue|"Detecting the signal of the biomarker, COX2, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of COX2 strength signal|||Number
171068|NCT00118040|Secondary|Activated Caspase 3 in Tumor Tissue|"Detecting the signal of the biomarker, Activated Caspase 3, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of Caspase 3 strength signal|||Number
171069|NCT00118040|Secondary|Ki-67 in Tumor Tissue|"Detecting the signal of the biomarker, Ki-67, in the tumor tissue after being on study drug for between 14-21 days as a way to measuring the effects G-2535 have on it with regards to proliferation, apoptosis, and other processes relevant to bladder cancer.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of Ki-67 strength signal|||Number
171070|NCT00118040|Secondary|EGFR in Benign Tissue|"Detecting the signal of the biomarker, EGFR, in the benign tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.||percentage of EGFR strength signal|||Number
171071|NCT00118040|Primary|pEGFR in Benign Tissue|"Detecting the signal of the biomarker, pEGFR, in the benign tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV.||percentage of pEGFR strength signal|||Number
171072|NCT00118040|Secondary|EGFR Mutations in Tumor Tissue|"Detecting the signal of EGFR mutations in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of EGFR strength signal|||Number
171073|NCT00118040|Secondary|Survivin in Tumor Tissue|"Detecting the signal of the biomarker, Survivin, in the tumor tissue after being on study drug for between 14-21 days.~Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms."|up to 21 days on Study Drug|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of Survivin strength signal|||Number
171074|NCT00118040|Secondary|Survivin in Urine by Visit (pg/ml)|Detecting the mean amount of the biomarker Survivin in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 16 for this outcome.||pg/ml||Standard Deviation|Mean
171075|NCT00118040|Secondary|BLCA-4 in Urine by Visit|Detecting the mean amount of the biomarker BLCA-4 in the urine of patients prior to starting study agent, at Day 8 and pre-surgery time (when they have been on study agent between 14-21 days). This is measured by urine analysis at each of the time points to serve as a surrogate tumor marker.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 17 for this outcome.||pg/ml||Standard Deviation|Mean
171076|NCT00118040|Primary|Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment|Strong, Moderate, Weak, and Negative are categorized based on the signal. The measurements display the strength of the signal between the different Arms.|up to 21 days|For this outcome Arm 1 and Arm II were analyzed together which lead to Arm IV. Also for Arm III although 14 participants successfully completed the study for this group they were able to analyzed 15 for this outcome.||percentage of pEGFR strength signal|||Number
171077|NCT00117988|Primary|Number of Patients With Response|Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses.|Baseline to time to best response; Every 6 weeks|Analysis was intention to treat (ITT). All participants with baseline and at least one post baseline target lesion measurement were included.||participants|||Number
171078|NCT00117962|Other Pre-specified|Overall Survival|Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Time from randomization to death (up to 4 years)|||months||95% Confidence Interval|Median
171079|NCT00117962|Secondary|Number of Participants With Overall Tumor Response|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Overall tumor response is the total number of CR and PRs."|Duration of study until progression (up to 4 years)|||participants|||Number
171080|NCT00117962|Secondary|Failure-free Survival|Failure-free survival (FFS) is the time from randomization to a failure event, defined as disease progression or death from any cause (which ever occurred first). The median FFS with 95% CI was estimated using the Kaplan-Meier method,|Time from randomization to failure (up to 4 years)|||months||95% Confidence Interval|Median
171081|NCT00117962|Primary|18 Month Survival|Percentage of participants who were alive at 18 months. The 18 month survival, with 95% CI, was estimated using the Kaplan-Meier method.|18 months (from randomization)|||percentage of participants||95% Confidence Interval|Number
171082|NCT00117949|Secondary|Liver Function Tests|The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months|||participants|||Number
171083|NCT00117949|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only one participant reached a 90% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).||days||Full Range|Median
171084|NCT00117949|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation. In the 40 mg group only two participants reached a 50% reduction in PSA and the Kaplan-Meier estimate could not be calculated (ie no statistical analysis is presented for this group).||days||Full Range|Median
171085|NCT00117949|Primary|Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days|"The number of participants suppressed for at least 28 days was defined as the estimated survival probability at time=Day 28."|28 days|||participants|||Number
171086|NCT00117949|Secondary|Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days|Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months|||participants|||Number
171087|NCT00117949|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.|1, 3, 7, 14, 21, 28, 42 days|Half participants in the 40 mg group were not castrated and the median was not calculated (no statistical anaylsis was made). Two participants out of 24 in the 80 mg, 1/24 in the 120 mg, and 3/24 in the 160 mg groups were not castrated. For the 160 mg group the 95% CI was non-estimable and no statistical anaylsis was made.||days|||Number
171088|NCT00117949|Primary|Time to Meet Insufficient Testosterone Response|Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.|3 months|Patients who withdrew without meeting the insufficient testosterone (T) suppression criteria were censored as of the time for last available T measurement prior to discontinuation. For the 40 mg group the 95% confidence interval around the time estimate was non-estimable and no statistical analysis is presented (the estimate was 14 days).||days||Full Range|Median
171089|NCT00117845|Secondary|Safety|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|72 months|||Participants|||Number
171090|NCT00117845|Primary|Response Rate|Response rate is based on the number of patients who achieve either a complete response (CR) or partial response (PR) to therapy. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Partial response is reduction by >=50% of leukemia cell count or >=50% reduction is the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.|up to 12 months|||Participants|||Number
171091|NCT00117806|Primary|Competitive Employment-Percentage of Participants With Competitive Employment|Employment outcomes during year 1 among those subjects obtaining competitive employment.|12 months|||percentage of participants||95% Confidence Interval|Number
171092|NCT00117806|Primary|Competitive Employment-Participants With Competitive Employment|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months|||Participants with competitive employment|||Number
171093|NCT00117806|Primary|Competitive Employment-Total Jobs|Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.|12 months|||Total Competitive Employments|||Number
171094|NCT00117793|Secondary|Frustration (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. Frustration was assessed by frequency of occurrence and rating. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., least frustrating).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||units on a scale||Standard Deviation|Mean
171095|NCT00117793|Secondary|Ambulation (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Ambulation scale queries the ability to walk in general, in close spaces, on stairs and ramps, in urban environments, and on slippery surfaces. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., easiest to walk on).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||units on a scale||Standard Deviation|Mean
171096|NCT00117793|Secondary|Residual Limb Health (PEQ Scale)|Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Residual Limb Health scale examines: sweat, smell, volume changes, rashes, ingrown hairs, and blisters. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., most healthful).|Measurements were taken after wearing the study prosthesis for four weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||units on a scale||Standard Deviation|Mean
171097|NCT00117793|Primary|Limb Pistoning|Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place.|Measurements were taken after wearing the study prosthesis for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||mm||Standard Deviation|Mean
171098|NCT00117793|Primary|Activity Level|Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS).|Two weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||steps (in thousands)||Standard Deviation|Mean
171099|NCT00117793|Primary|Limb Volume||Measurements were taken after wearing the study prostheses for three weeks|The number of participants for analysis is equal to the number of participants who completed the study protocol.||liters||Standard Deviation|Mean
171100|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171101|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171102|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171103|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171104|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171105|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171106|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 95|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171107|NCT00117676|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 48, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171108|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, and 384|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
171109|NCT00117676|Secondary|Percentage of Participants With HBsAg Loss and/or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 96. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 96.|Baseline; Week 96|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
171110|NCT00117676|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion Antibody to HBs (Anti-HBs) at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with available data were analyzed.||percentage of participants|||Number
171111|NCT00117676|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, and 384||Week 48; Weeks 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units per liter||Standard Deviation|Mean
171112|NCT00117676|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units per liter||Standard Deviation|Mean
171113|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171114|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Weeks 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171115|NCT00117676|Secondary|Percentage of Participants With ALT Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171197|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171116|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171117|NCT00117676|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171118|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units on a scale||Standard Deviation|Mean
171119|NCT00117676|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.||units on a scale||Standard Deviation|Mean
171120|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171121|NCT00117676|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171122|NCT00117676|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, and 384||Week 48; Weeks 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 copies/mL||Standard Deviation|Mean
171123|NCT00117676|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 copies/mL||Standard Deviation|Mean
171124|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
171125|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
171126|NCT00117676|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171198|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-3|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171127|NCT00117676|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171128|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the Second Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 45 subjects in Sorafenib 400/600 mg bid group and 58 in Interferon/Sorafenib 400 mg bid group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)||participant s|||Number
171129|NCT00117637|Secondary|Analysis of the Eastern Co-operative Oncology Group (ECOG) Status at the End of the First Intervention Period|Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst).|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|At the time of the analysis, only 95 subjects in Sorafenib 400 mg bid group and 89 in Interferon group were documented by study investigators due to various reasons (drop-out of patients by AEs, death etc.)||participants|||Number
171130|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the Second Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation) was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|||months||Full Range|Median
171131|NCT00117637|Secondary|Time to Response According to the Investigator Assessment for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 3 years and 9 months later, assessed every 4 weeks|||months||Full Range|Median
171132|NCT00117637|Secondary|Time to Response According to the Independent Radiological Review for the First Intervention Period|Time to Response (TTR) for subjects who achieved a response (Complete Response (CR) or Partial Response (PR) with confirmation was defined as the time from date of randomization to the earliest date that the response was first documented|From randomization of the first subject until 15 months later, assessed every 8 weeks|||months||Full Range|Median
171133|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the Second Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||Full Range|Median
171134|NCT00117637|Secondary|Duration of Response According to the Investigator Assessment for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||Full Range|Median
171135|NCT00117637|Secondary|Duration of Response According to the Independent Radiological Review for the First Intervention Period|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 15 months later, assessed every 8 weeks|||months||Full Range|Median
171136|NCT00117637|Secondary|Average of All Trough Plasma Concentrations|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID).|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg or 600 mg BID) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.||100*mg/L||95% Confidence Interval|Geometric Mean
171137|NCT00117637|Secondary|Slope - Change in Trough Concentration/Cycle|Plasma samples were collected prior to dosing every 4 weeks after the patient reached steady-state (at least 10 days at 400 mg BID (bis in die, twice daily)) to assess any potential trends in trough concentration over time.|From start of treatment of the first subject until 15 months later assessed every 4 weeks.|Patients who started on Sorafenib, not Interferon, and had been at the same dose (400 mg) for at least 10 days were considered valid for the analysis. Concentrations collected between 10-14 hours from the last dose were included in the analysis.||100*(mg/L/cycle)||95% Confidence Interval|Mean
171138|NCT00117637|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
175454|NCT00076752|Primary|Relapse-free Complete Clinical Response||60 months|Ninth participant was taken off study before proceeding with transplant per principal investigator due to decision to put study on hold.||Months||Full Range|Median
171139|NCT00117637|Secondary|Progression Free Survival According to the Investigator Assessment (Second Intervention Period)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
171140|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the Second Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
171141|NCT00117637|Secondary|Tumor Response According to the Investigator Assessment for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
171142|NCT00117637|Secondary|Tumor Response According to the Independent Radiological Review for the First Intervention Period|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks|||participants|||Number
171143|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171144|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171145|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171146|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the Second Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171163|NCT00117598|Other Pre-specified|Time to Failure (TTF)|TTF is defined as the time from randomization to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death (any cause).|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT||months||95% Confidence Interval|Median
175505|NCT00076050|Primary|Change From Baseline in Bone Mineral Density||baseline and 2 years|||g/cm2||Standard Deviation|Mean
171147|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Global Satisfaction) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171148|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Convenience) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171149|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Side Effects) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171150|NCT00117637|Secondary|Analysis of the Treatment Tolerability (Effectiveness) by Use of Treatment Satisfaction Questionnaire for Medication (TSQM) for the First Intervention Period|The TSQM comprises 14 questions dispatched within 4 domains (effectiveness, side effects, convenience, and global satisfaction). Each question was answered on either a 5-point or 7-point scale. Each domain score can vary from 0 to 100 with higher scores indicating subject reported higher effectiveness of treatment, less bothered by side-effects, more convenient use of medication and overall greater satisfaction with the treatment. No total score is calculated.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171151|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the Second Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171152|NCT00117637|Secondary|Analysis of the Quality of Life (QoL) by Use of Functional Assessment of Cancer Therapy-Biologic-response Modifiers (FACT-BRM) for the First Intervention Period|The FACT-BRM comprises 40 questions within 6 domains (physical well being, social/family well being, emotional well being, additional concern: physical, and additional concern: emotional). Each question was answered on a five point scale from 0 (not at all) to 4 (very much). The total score range is from 0 to 160 with higher scores indicating better QoL.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171153|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171164|NCT00117598|Other Pre-specified|Duration of Response|Time from the first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented; censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants who had a response||months||95% Confidence Interval|Median
171199|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in HDL-2|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171154|NCT00117637|Secondary|Analysis of the Quality of Life by Use of Total Score of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the First Intervention Period|The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns.|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171155|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) for the Second Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171156|NCT00117637|Secondary|Analysis of the Quality of Life by Use of the Respiratory Domain of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) After Intervention for the First Intervention Period|"The FKSI questionnaire comprises 15 questions dispatched within 4 domains (respiratory, pain, general symptoms and overall Quality of Life (QoL)) plus 2 individual items. Each question was answered on a five point scale from 0 (not at all) to 4 (very much) indicating the severity of symptoms. The total score range was from 0 to 60 with higher scores indicating subjects reported fewer kidney cancer related symptoms and concerns. The respiratory domain of the FKSI comprises 2 questions: I have been short in breath and I have been coughing; its score ranges from 0 to 8."|From randomization of the first subject until 15 months later, assessed every 8 weeks|The number of analyzed patients regarding quality of life parameters varied considerably due to missing questionnaires which had not been filled in by patients or invalidity of these questionnaires according to the protocol.||scores on a scale||95% Confidence Interval|Least Squares Mean
171157|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the Second Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
171158|NCT00117637|Secondary|Disease Control (DC) According to the Investigator Assessment for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||participants|||Number
171159|NCT00117637|Secondary|Disease Control (DC) According to Independent Central Review for the First Intervention Period|Disease Control (DC) was defined as the total number of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating). CR: disappearance of tumor lesions (TL); PR: a decrease of at least 30% in the sum of TL sizes; SD: steady state of disease; PD: an increase of at least 20% in the sum of TL sizes.|From randomization of the first subject until 15 months later, assessed every 8 weeks|||participants|||Number
171160|NCT00117637|Secondary|Progression-free Survival (PFS) Based on Investigator Assessment for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
171161|NCT00117637|Primary|Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation|From randomization of the first subject until 15 months later, assessed every 8 weeks|||months||95% Confidence Interval|Median
171162|NCT00117598|Other Pre-specified|Time to Tumor Progression (TTP)|TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT||months||95% Confidence Interval|Median
171165|NCT00117598|Other Pre-specified|Time to Response|Time between the date of randomization and the first date of objective response for participants with a confirmed objective response.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT subset of participants with a confirmed objective response||months||95% Confidence Interval|Median
171167|NCT00117598|Secondary|Percentage of Participants With Objective Response|Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|ITT||percentage of participants||95% Confidence Interval|Number
171168|NCT00117598|Primary|Progression-Free Survival (PFS)|The period from randomization until disease progression, death or date of last contact.|Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)|Intent-to-Treat (ITT) Population: All randomized participants at time of primary analysis||months||95% Confidence Interval|Median
171169|NCT00117585|Primary|Orthostatic Hypotension at Discharge|Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.|Last three blood pressures prior to discharge|||participants|||Number
171170|NCT00117559|Primary|BDI|"Beck Depression Inventory - measures depression. Range for Total score = 0 to 63 Higher scores are indicative of increased depression~The Beck Depression Inventory (BDI; Beck & Steer, 1988) is a widely used 21-item self-report instrument designed to assess depressive mood and symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater severity of depressive symptoms for the past two weeks. A sample item is “I do not feel sad.” The BDI has demonstrated reliability (split-half reliability coefficient of .93) and validity (correlations with clinician ratings of depression range from .62 to .75; Beck, Steer, & Garbing, 1988). Cronbach’s alpha was high for the present sample at both time points (a = .91 and .90)."|8 weeks|||units on a scale||Standard Deviation|Mean
171171|NCT00117338|Secondary|Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration|Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.|120 minutes|At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of total doses of Beta-Agonist (mg) endpoint.||mg||Inter-Quartile Range|Median
171172|NCT00117338|Secondary|Change in FEV1 After 15 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value|Baseline and 15 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
171173|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighted average over) 30 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
171174|NCT00117338|Secondary|Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration|Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time-weighed average over) 45 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
171175|NCT00117338|Secondary|Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)|Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration.|120 minutes|Full Analysis Set (FAS). At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of treatment failure endpoint. Baseline FEV1 measurement was also required to assess this endpoint since it was included in the model.||Participants|||Number
171176|NCT00117338|Secondary|Change From Baseline in Modified Pulmonary Index [mPI] Score|"Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12.~The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use."|Baseline and 60 minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Score on a scale||95% Confidence Interval|Least Squares Mean
171177|NCT00117338|Primary|Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration|Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.|Baseline and (time weighted average over) 60 Minutes|Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.||Liters||95% Confidence Interval|Least Squares Mean
175795|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
171178|NCT00117312|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 years|These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).||participants|||Number
171179|NCT00117312|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 years|The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.||participants|||Number
171180|NCT00117286|Primary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.||participants|||Number
171181|NCT00117286|Primary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|5 years|The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.||participants|||Number
171182|NCT00117156|Post-Hoc|Delayed Pneumonia Toxicity Rate|Delayed pneumonia toxicity rate is the proportion of patients who experienced significant pneumonia toxicity defined as nocardia or pneumocystis jiroveci after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.||proportion of patients||95% Confidence Interval|Number
171183|NCT00117156|Post-Hoc|Delayed Bone Marrow Toxicity Rate|Delayed bone marrow toxicity rate is the proportion of patients who experienced significant bone marrow toxicity defined as aplastic anemia or myelodysplastic syndromes (MDS) after completing therapy.|Assessed after therapy completion incidentally or at a minimum every 6 months for 2 years and then annually up to 4 years.|The analysis dataset is comprised of all treated patients.||proportion of patients||95% Confidence Interval|Number
171184|NCT00117156|Secondary|3.1-Year Overall Survival|3.1-year overall survival is the probability of patients remaining alive 3.1 years from study entry.|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.||probability||95% Confidence Interval|Number
171185|NCT00117156|Secondary|3.1-Year Progression-Free Survival|3.1-year progression-free survival is the probability of patients remaining alive and progression-free at 3.1 years from study entry estimated using Kaplan-Meier methods. Disease progression was assessed per Cheson criteria (1999).|Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years|The analysis dataset is comprised of all treated patients.||probability||95% Confidence Interval|Number
171186|NCT00117156|Primary|Objective Response Rate|Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).|Assessed after three- and six-cycles of therapy.|The analysis dataset is comprised of all treated patients.||proportion of patients||95% Confidence Interval|Number
171187|NCT00116857|Primary|Beck Depression Inventory-II|Beck Depression Inventory-II scores on a scale of 0 to 63, minimum score equals 0 maximum score equals 63. Higher value represents a worse outcome. Baseline scores are compared to scores after treatment.|Measured at Baseline and 10 weeks|||units on a scale||Standard Deviation|Mean
171188|NCT00116831|Secondary|Number of Other Cardiovascular Events|This was one of the secondary endpoints of the study.|Baseline to Month 21|Safety Population||Number of events|||Number
171189|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population||Participants|||Number
171190|NCT00116831|Secondary|Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)|This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.|Baseline to Month 21|Safety Population||Participants|||Number
171191|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||ratio||Standard Error|Mean
171192|NCT00116831|Secondary|Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||ratio||Standard Error|Mean
171193|NCT00116831|Secondary|Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation|From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||Ratio||Standard Error|Mean
171194|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Apoprotein B (apoB)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171195|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171200|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171201|NCT00116831|Secondary|Percent Change From Baseline to Month 18 in Total Cholesterol (TC)|Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171202|NCT00116831|Secondary|Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure.|Baseline to Month 18|ITT Population with LOCF||percent change|||Number
171203|NCT00116831|Secondary|Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18|It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups.|Baseline to Month 18|ITT Population with LOCF||percent change|||Number
171204|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171205|NCT00116831|Secondary|Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18|Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||percent change|||Number
171206|NCT00116831|Secondary|Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.|Baseline to Month 18|ITT Population without LOCF||millimole/Liter (mmol/L)||Standard Error|Mean
171207|NCT00116831|Secondary|Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18|From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit.|Baseline to Month 18|Intent-to-Treat (ITT) Population without Last Observation Carried Forward (LOCF). ITT population was defined as all participants in the study who were randomized and have at least one on-therapy value for an efficacy assessment.||Percentage||Standard Error|Mean
171208|NCT00116831|Secondary|Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters squared (mm2)||Standard Error|Mean
171209|NCT00116831|Secondary|Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters squared (mm2)||Standard Deviation|Mean
171210|NCT00116831|Secondary|Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters cubed (mm3)||Standard Error|Mean
171211|NCT00116831|Secondary|Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline|IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area|Baseline to Month 18|IVUS Evaluable Population with last observation carried forward (LOCF)||millimeters cubed (mm3)||Standard Deviation|Mean
171212|NCT00116831|Secondary|Model Adjusted Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
171213|NCT00116831|Primary|Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)||percent (absolute change)||Standard Error|Mean
171214|NCT00116831|Primary|Change From Baseline in Percent Atheroma Volume (PAV) to Month 18|The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.|Baseline to Month 18|IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit [≥ 9 months] IVUS imaging assessment.)||percent (absolute change)||Standard Deviation|Mean
171215|NCT00116831|Secondary|Change From Baseline in Normalized Atheroma Volume|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Deviation|Mean
171216|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters square (mm2)||Standard Error|Mean
171217|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters square (mm2)||Standard Error|Mean
171218|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters square (mm2)||Standard Error|Mean
171219|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population||millimeters squared (mm2)||Standard Deviation|Mean
171220|NCT00116831|Secondary|Model Adjusted Change From Baseline in Vessel Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
171221|NCT00116831|Secondary|Model Adjusted Change From Baseline in Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
171222|NCT00116831|Secondary|Model Adjusted Change From Baseline in Atheroma Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Error|Mean
171223|NCT00116831|Secondary|Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18|IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18|Baseline to Month 18|IVUS Evaluable Population||millimeters cubed (mm3)||Standard Deviation|Mean
171224|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 384 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 337 to 384|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 336 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171225|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 336 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 289 to 336|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 288 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171226|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 288 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 241 to 288|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 240 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171227|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 240 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 193 to 240|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 192 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171228|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 192 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 145 to 192|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 144 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171229|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 144 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 97 to 144|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 96 with available data were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171230|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 96 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition.|Baseline; Weeks 49 to 95|Participants in the Randomized and Treated Analysis Set who continued on the study after Week 48 (ie, entered the open-label phase) were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171231|NCT00116805|Secondary|Number of Participants With HBV Genotypic Changes From Baseline at Week 48 (Resistance Surveillance)|Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set were analyzed to determine if they qualified for protocol criteria for resistance surveillance, and those meeting the criteria were evaluated.||participants|||Number
171232|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Weeks 144, 192, 240, 288, 336, and 384|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
171233|NCT00116805|Secondary|Percentage of Participants With HBsAg Loss or Seroconversion to Anti-HBs at Week 96|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point.|Baseline; Weeks 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data is included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
171234|NCT00116805|Secondary|Percentage of Participants With Hepatitis B S-Antigen (HBsAg) Loss or Seroconversion at Week 48|HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48.|Week 48|Participants in the Randomized and Treated Analysis Set with available data were analyzed.||percentage of participants|||Number
171235|NCT00116805|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion to Anti-HBe at Week 96|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 96. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 96.|Baseline to Week 96|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
171236|NCT00116805|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss/Seroconversion at Week 48|HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 48. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 48.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set who were HBeAg-positive at baseline and with available data were analyzed.||percentage of participants|||Number
171237|NCT00116805|Secondary|Change From Week 48 in ALT at Weeks 96, 144, 192, 240, 288, 336, and 384||Week 48; Weeks 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||U/L||Standard Deviation|Mean
171238|NCT00116805|Secondary|Change From Baseline in ALT at Weeks 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||U/L||Standard Deviation|Mean
171239|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Weeks 144, 192, 240, 288, 336, and 384|ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Weeks 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171250|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 144, 192, 240, 288, 336, and 384||Weeks 144, 192, 240, 288, 336, and 384|Randomized and Treated Analysis Set. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria. Participants with missing values related to protocol criteria or who added FTC to their open-label TDF regimen were considered to have failed to reach the endpoint.||percentage of participants|||Number
171240|NCT00116805|Secondary|Percentage of Participants With ALT Normalization at Week 96|ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 96|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline. Data included for participants who had discontinued unless the reason for discontinuation was unrelated to protocol criteria; data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171241|NCT00116805|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48|ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with ALT > ULN at baseline and available data were analyzed; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171242|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 240|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171243|NCT00116805|Secondary|Ranked Assessment of Necroinflammation and Fibrosis at Week 48|Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171244|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 240|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||units on a scale||Standard Deviation|Mean
171245|NCT00116805|Secondary|Change From Baseline in Knodell and Ishak Necroinflammatory Scores at Week 48|The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst).|Baseline; Week 48|Participants in the Randomized and Treated Analysis Set with measurements at Baseline and Week 48 were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis.||units on a scale||Standard Deviation|Mean
171246|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 240|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 240|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||percentage of participants|||Number
171247|NCT00116805|Secondary|Percentage of Participants With Histological Response at Week 48|Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.|Baseline; Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171248|NCT00116805|Secondary|Change From Week 48 in HBV DNA at Weeks 96, 144, 192, 240, 288, 336, and 384||Week 48; Weeks 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 IU/mL||Standard Deviation|Mean
171249|NCT00116805|Secondary|Change From Baseline in HBV DNA at Weeks 48, 96, 144, 192, 240, 288, 336, and 384||Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, and 384|Participants in the Randomized and Treated Analysis Set with observed data were analyzed; the missing-equals-excluded approach was used where participants with missing data were excluded from the analysis. Data for participants who added FTC to their open-label TDF regimen were included in the analysis.||log10 IU/mL||Standard Deviation|Mean
171301|NCT00116272|Secondary|Birth Weight Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available||g||Standard Deviation|Mean
171251|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Participants in the Randomized and Treated Analysis Set with available data were analyzed. Data included for participants who discontinued study unless the discontinuation was unrelated to protocol criteria.||percentage of participants|||Number
171252|NCT00116805|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 48||Week 48|Randomized and Treated Analysis Set; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171253|NCT00116805|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL and Histological Improvement (2-point Reduction in Knodell Necroinflammatory Score Without Worsening in Knodell Fibrosis Score) at Week 48|"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40."|Baseline; Week 48|Randomized and Treated Analysis Set: all participants who were randomized and received at least one dose of study medication; the missing-equals-failure approach was used where participants with missing data were considered to have failed to reach the endpoint.||percentage of participants|||Number
171254|NCT00116779|Secondary|Participants With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61||participants|||Number
171255|NCT00116779|Secondary|Number of Participants With Abnormal Total Bilirubin Values|Participants with abnormal total bilirubin values|Day 1 - 364|ITT population||participants|||Number
171256|NCT00116779|Secondary|Number of Participants With Abnormal Aspartate Aminotransferase Values|Participants with aspartate aminotransferase values that were above the normal range.|Day 1 - 364|ITT population||participants|||Number
171257|NCT00116779|Secondary|Number of Participants With Abnormal Alanine Aminotransferase Values|Participants whose alanine aminotransferase values were at levels above the normal range.|Day 1 through day 364|ITT population||participants|||Number
171258|NCT00116779|Secondary|Median Testosterone Levels at Various Days During the Study|Testosterone levels at baseline and days 1, 3, 7, 14 and 364|Baseline, Days 1,3,7,14,364|ITT population||nanograms / milliliter||Full Range|Median
171259|NCT00116779|Secondary|Median Luteinizing Hormone Levels at Various Study Timeframes|Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.|Baseline, Days 1, 3, 7, 14|ITT population||international units / liter||Full Range|Median
171260|NCT00116779|Secondary|Median Prostate-Specific Antigen Values at Various Study Timepoints|Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.|Baseline, Days 3, 14, 28, 84, 364|ITT population||nanogram / milliliter||Full Range|Median
171261|NCT00116779|Secondary|Median Di-Hydrotestosterone Levels At Various Study Timepoints|Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14|Baseline, Days 1, 3, 7, 14|ITT population||picogram / milliliter||Full Range|Median
171262|NCT00116779|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.|Day 0 (post dose) to Day 364|ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.||days||Full Range|Median
171263|NCT00116779|Secondary|Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population||days||Full Range|Median
171264|NCT00116779|Primary|Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28|Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.|Day 28 - Day 364|ITT population of participants who completed the study and had a testosterone level of <=0.5 nanogram per milliliter at Day 28.||participants|||Number
171265|NCT00116779|Secondary|Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.|Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.|Day 3|ITT population||participants|||Number
171266|NCT00116779|Primary|Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364|Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364|Day 28 to Day 364|ITT population of patients who completed the study and had testosterone <=0.5 nanogram per milliliter at Day 28.||participants|||Number
171267|NCT00116753|Secondary|Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|12 or 13 months|ITT population.||participants|||Number
171268|NCT00116753|Secondary|Liver Function Tests|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|12 or 13 months|ITT population.||participants|||Number
171269|NCT00116753|Secondary|Number of Participants With Testosterone <=0.5 ng/mL at Day 28|Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.|28 Days|Observed Cases in ITT population.||participants|||Number
171270|NCT00116753|Secondary|Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study|Figures in the table give the number of participants with all testosterone values <=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.|From after Day 28 to 12 or 13 months|Observed Cases in ITT population.||participants|||Number
171271|NCT00116753|Primary|Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study|Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.|From Day 28 to 12 or 13 months|Observed Cases in ITT population.||participants|||Number
171272|NCT00116688|Secondary|Patient Global Assessment|The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.|Week 1 and Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
171273|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent’s self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
171274|NCT00116688|Secondary|Change From Baseline in Euroqol-5D (EQ-5D) Index Score|The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
171275|NCT00116688|Secondary|Change From Baseline in Short Form 36 (SF-36)|The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
171276|NCT00116688|Secondary|Change From Baseline in ITP Patient Assessment Questionnaire|The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women’s Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.|Baseline to Week 48|Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.||scores on a scale||Standard Deviation|Mean
171277|NCT00116688|Secondary|Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies|The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.|Duration of treatment (up to 277 weeks)|Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.||Participants|||Number
171278|NCT00116688|Secondary|Number of Participants With a Platelet Response|Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications.|Duration of treatment (up to 277 weeks)|Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim||Participants|||Number
171279|NCT00116688|Primary|Number of Participants With Adverse Events|Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.|Duration of treatment plus 8 weeks (up to 285 weeks)|Safety Analysis Set, composed of all participants who received at least one dose of romiplostim||Participants|||Number
171280|NCT00116649|Secondary|Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count|Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count|At Month 18|The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit||percent reduction||Standard Deviation|Mean
171281|NCT00116649|Primary|Number of Participants Who Experienced an Adverse Event|Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.|from first dose up to 18 months|There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.||participants|||Number
171282|NCT00116428|Secondary|Percentage of Subjects Responded to Each of the Four Health Status Categories.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed the two-year health survey.||Percentage of Participants|||Number
171283|NCT00116428|Secondary|Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.|At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.|During the two years of post procedure|Subjects who completed two years follow up||Percentage of Participants|||Number
171302|NCT00116272|Secondary|Gestational Age at Delivery (GAD) of Live Births||At birth|Live births in women enrolled and exposed to etanercept prior to 37 weeks’ gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), excluding multiple births.||weeks||Standard Deviation|Mean
171284|NCT00116428|Secondary|The Percentage of Subjects Who Achieved Acute Success.|Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.|90 days post study procedure|This analysis population is based on the first study ablation procedure.||Percentage of participants|||Number
171285|NCT00116428|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis,diaphragmatic paralysis, atrio-esophageal fistula,transient ischemic attack,stroke,cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade,pericardial effusion,pneumothorax,atrial perforation,vascular access complications,pulmonary edema,hospitalization (initial and prolonged), and heart block.|Within 7 Days of Ablation Procedure|Analysis population includes those enrolled subjects undergoing a study ablation procedure. A total of 139 underwent the procedure, including 36 AAD (control) group subjects who underwent the procedure after failing the effectiveness endpoint. The remaining 25 AAD (control) subjects didn't have the ablation procedure.||Percentage of Participants|||Number
171286|NCT00116428|Primary|The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)|Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.|The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.|||Percentage of participants|||Number
171287|NCT00116272|Secondary|Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)|"The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: Yes,” “Sometimes,” “Not Yet,” with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported."|1 year after birth|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, where data were available.||Percentage of infants|||Number
171288|NCT00116272|Secondary|Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).||Percentage of infants|||Number
171289|NCT00116272|Secondary|Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year||From birth to 1 year|Live-born infants, including singletons and 1 randomly selected twin from multiple pregnancies, born to enrolled women exposed to etanercept at any time during pregnancy (Etanercept-Exposed).||Percentage of infants|||Number
171290|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
171291|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Length|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
171292|NCT00116272|Secondary|Percentage of Infants at One Year of Age With Small for Gestational Age Weight|Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement.|1 year after birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
171293|NCT00116272|Secondary|Postnatal Head Circumference Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available||percentile||Standard Deviation|Mean
171294|NCT00116272|Secondary|Postnatal Length Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available||percentile||Standard Deviation|Mean
171295|NCT00116272|Secondary|Postnatal Weight Percentile at One Year||1 year after birth|Live-born infants, excluding multiple births, where 1-year data were available||percentile||Standard Deviation|Mean
171296|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Head Circumference|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
171297|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Length|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
171298|NCT00116272|Secondary|Percentage of Infants With Small for Gestational Age Birth Weight|Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves.|At birth|Live-born infants, excluding multiple births, where data were available.||percentage of infants|||Number
171299|NCT00116272|Secondary|Birth Head Circumference Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available||cm||Standard Deviation|Mean
171300|NCT00116272|Secondary|Birth Length Among Full Term Infants||At birth|Live birth full-term infants, excluding multiple births, where data were available||cm||Standard Deviation|Mean
171303|NCT00116272|Secondary|Percentage of Participants With Pre-term Delivery|A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks’ gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded.|9 months|Participants enrolled and exposed to etanercept prior to 37 weeks gestation (Etanercept-Exposed) or enrolled prior to 37 weeks gestation (Diseased Controls), and excluding multiple births.||percentage of participants||95% Confidence Interval|Number
171304|NCT00116272|Secondary|Percentage of Pregnancies Ending in Spontaneous Abortion|Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event.|9 months|Participants enrolled and exposed to etanercept prior to 20 weeks gestation (Etanercept-Exposed) or enrolled prior to 20 weeks gestation (Diseased Controls).||percentage of pregnancies||95% Confidence Interval|Number
171305|NCT00116272|Secondary|Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group.|From birth through 1 year of age|Children born to enrolled participants who received the dysmorphological exam. Includes multiples who received the exam for consideration of pattern; co-twins with the same 3 or more minor defects could not constitute a pattern on their own. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.||percentage of infants|||Number
171306|NCT00116272|Secondary|Percentage of Infants With Any 3 or More Minor Birth Defects|A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Children born to enrolled participants during the study who received the dysmorphological exam. Includes singletons and 1 randomly selected twin from twin pairs. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.||percentage of infants|||Number
171307|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in All Pregnancies|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies counted as 1 outcome; any 1 or more malformed infant counted as 1 major malformation in the numerator and 1 outcome in the denominator. Excludes 9 lost-to-follow-up in Etanercept-Exposed and 6 in Diseased Controls cohort. Only women exposed to etanercept in 1st trimester are included in the Etanercept-Exposed cohort.||percentage of participants|||Number
171308|NCT00116272|Primary|Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants|A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.|From birth through 1 year of age|Includes multiple pregnancies ending in at least 1 live-born infant; any 1 or more malformed live-born infants counted as 1 major malformation outcome in the numerator, and 1 pregnancy outcome in the denominator. Only women exposed to etanercept in the 1st trimester are included in the Etanercept-Exposed cohort.||percentage of participants|||Number
171309|NCT00116207|Secondary|Inflammation|High Sensitivity CRP (nmol/L)|24 months|||nmol/L||Standard Deviation|Mean
171310|NCT00116207|Secondary|Systemic Oxidative Stress|ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection|24 months|||ng/G creatinine||Standard Deviation|Mean
171311|NCT00116207|Secondary|Global Coronary Flow Reserve as a Measure of Endothelial Function|global myocardial blood flow reserve as a measure of endothelial function. Measured by PET using [13N]ammonia at rest and during adenosine stimulated coronary vasodilation.|Baseline, 24 months|||ratio (rest:stress)||Standard Deviation|Mean
171312|NCT00116207|Primary|Global [11C]HED Retention Index (RI)|"Distal defects in [11C]meta-hydroxyephedrine ([11C]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as [11C]HEDblood min -1[ml tissue]-1~PET Data of Randomized Subjects at Baseline and 24-Months~The primary outcome was the change in the global [11C]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with those on placebo."|Baseline, 24 months|||Retention index||Standard Deviation|Mean
171313|NCT00116168|Secondary|Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F)|Vz/F of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Liters||Standard Deviation|Mean
171314|NCT00116168|Secondary|Half-life (T1/2)|T1/2 of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Days||Standard Deviation|Mean
171315|NCT00116168|Secondary|Total Body Clearance (CL)|CL of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Liter per day||Standard Deviation|Mean
171316|NCT00116168|Secondary|Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]|AUC(ext) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Percent||Standard Deviation|Mean
171317|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528|AUC(0-infinity) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Microgram times day per milliliter||Standard Deviation|Mean
171318|NCT00116168|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]|AUC(0-t) of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Micrograms times day per milliliter||Standard Deviation|Mean
171319|NCT00116168|Secondary|Observed Maximum Serum Concentration (Cmax)|Cmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Micrograms per milliliter||Standard Deviation|Mean
171320|NCT00116168|Secondary|Time to Observed Maximum Serum Concentration (Tmax)|Tmax of MEDI-528|Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis.||Days||Standard Deviation|Mean
171321|NCT00116168|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI-528|Number of participants with ADA to MEDI-528|Days 0, 14, 28, 42, and 84|All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0)||Participants|||Number
171322|NCT00116168|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
171323|NCT00116168|Primary|Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain|Number of participants with changes from baseline in the Day 28 MRI of the brain|Days 0 and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
171324|NCT00116168|Primary|Incidence of Clinically Significant Changes From Baseline in Neurologic Exam|Number of participants with clinically significant changes from baseline in neurologic exam|Days 0, 7, 14, 21, 28, 42, and 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
171325|NCT00116168|Primary|Incidence of Abnormal Troponin Levels|Number of participants with troponin levels greater than upper limit of normal|Days 0, 1, 7, 14, and 28|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
171326|NCT00116168|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 0 - 84|All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina)||Participants|||Number
171327|NCT00115349|Secondary|Adverse Events||continous||||||
171328|NCT00115349|Secondary|Initiation of or Increase in Cardiac Medications||continuous||||||
171329|NCT00115349|Secondary|Change in Holter Monitor Scores From Baseline to One Year.||one year||||||
171330|NCT00115349|Secondary|Change in ECHO LV Volume, Ejection Fraction, Shortening Fraction, and VCFc/Wall Stress Z-score From Baseline to One Year.||one year||||||
171331|NCT00115349|Secondary|Change in Left Ventricular (LV) Volume From Screening to One Year.||one year||||||
171332|NCT00115349|Secondary|Evaluate Whether L1/DFO Combination Therapy is Superior to DFO Monotherapy in Lowering Myocardial Iron Burden Estimated by Myocardial T2*.||one year||||||
171333|NCT00115349|Primary|Change in Left Ventricular Ejection Fraction (LVEF).|The primary outcome variable is change in left ventricular ejection fraction (blood ejected from the heart into the body) as measured by MRI from baseline to one year. The unit of primary outcome (left ventricular ejection fraction) is the percent of the blood in left ventricle.|Baseline to one year|||Percent of the blood in left ventricle||Standard Error|Least Squares Mean
171334|NCT00115297|Secondary|Rescue Beta Agonist Use||Measured during the daytime|||participants|||Number
171335|NCT00115297|Secondary|Wheezing at Day 7||Study day 7|||participants|||Number
171336|NCT00115297|Primary|Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)||First 56 days of study|||Days||Inter-Quartile Range|Median
171337|NCT00115934|Secondary|Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Stage II Discharge to 14 Months of Age, an average of 8.9 months|These numbers reflect the number of patients who were discharged from the hospital after the Stage 2 procedure and were transplant-free.||complications|||Number
171338|NCT00115934|Secondary|Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|From Norwood Discharge to Stage II discharge, an average of 4.2 months|These numbers reflect those patients who were discharged from the hospital after the Norwood procedure and were transplant free.||complications|||Number
171339|NCT00115934|Secondary|Complications: Total Number Experienced During Norwood Hospitalization|Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.|Norwood Hospitalization, an average of 36 days|||complications|||Number
171340|NCT00115934|Secondary|Unintended Cardiovascular Interventional Procedures|Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.|From Randomization to 12 months|||procedures|||Number
171341|NCT00115934|Secondary|Angiographic Findings: Right Pulmonary Artery Size|Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.||mm||Standard Deviation|Mean
171342|NCT00115934|Secondary|Angiographic Findings: Left Pulmonary Artery Size|Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).|Measured pre-stage II surgery, on average 26 days prior to stage II palliation|These patients had pre-stage II palliation visits with acceptable cardiac catheterizations.||mm||Standard Deviation|Mean
171343|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||Percentage of RV end-diastolic volume||Standard Deviation|Mean
171344|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||Percentage of RV end-diastolic volume||Standard Deviation|Mean
171345|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction|Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes used to calculate the ejection fraction.||Percentage of RV end-diastolic volume||Standard Deviation|Mean
171346|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
171347|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
171348|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA|Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
171349|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured at 14 months of age|184 and 179 patients remained in the MBTS and RVPAS groups at the 14-months of age echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
171368|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Wild-type KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with irinotecan||Participant|||Number
171350|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured pre-stage II surgery, an average of 15 days pre-stage II surgery|181 and 214 patients remained in the MBTS and RVPAS groups at the time of the pre-Stage II echo. Of these, some patients did not have acceptable echos or not all measures were able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
171351|NCT00115934|Secondary|Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)|Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.|Measured post-Norwood, an average of 17 days post-Norwood|241 and 239 patients remained in the MBTS and RVPAS groups at the time of the post-Norwood echo. Of these, some patients did not have acceptable echos or measures were not able to be obtained to calculate the volumes.||ml/m^2.6||Inter-Quartile Range|Median
171352|NCT00115934|Secondary|Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial|This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.|From Randomization to the End of the Trial, an average of 32 months|||Participants|||Number
171353|NCT00115934|Primary|Proportion of Patients Who Died or Received a Heart Transplant|The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.|Measured at 12 months|555 subjects were enrolled in the study; 5 of these subjects were excluded from analyses because a Norwood procedure was not performed; 1 subject was excluded because the subject withdrew before the 12-month follow-up, 12-month status was unknown. The data were analyzed on an intention to treat basis, subjects were analyzed as randomized.||Participants|||Number
171354|NCT00115869|Primary|Whether or Not Smoking Daily at 2 Years After High School|"Response (from the 2-years-after-high school questionnaire) Daily: 1 to 10 cigarettes a day, Daily: 11 to 20 cigarettes a day, Daily: more than a pack a day to the Item How often do you currently smoke cigarettes?"|2 years after high school|||participants|||Number
171355|NCT00115869|Primary|Number of Participants Smoking Daily at 12th Grade|"Response 1 to 3 cigarettes per day, 4 to 10 cigarettes per day, 11 to 20 cigarettes per day, or More than 20 cigarettes per day to the Item How often do you currently smoke cigarettes?"|12th grade|||participants|||Number
171356|NCT00115804|Secondary|Fibromyalgia Impact Questionnaire Modified for Children|A 19 item self-report instrument that measures overall impact of fibromyalgia including assessments of function, pain, fatigue, sleep quality, stiffness, anxiety and depression. Score range from 0 (no impact) to 100 (severe impact).|Over the past week.|||units on a scale||Standard Deviation|Mean
171357|NCT00115804|Secondary|Multidimensional Anxiety Scale for Children|A 39-item self-report inventory that assesses four areas of anxiety symptoms (emotional, cognitive, physical, and behavioral). Score ranges from 0 (no anxiety symptoms) to 117 (severe anxiety symptoms).|Over the past week.|||units on a scale||Standard Deviation|Mean
171358|NCT00115804|Secondary|Children's Depression Inventory|A 27-item, self-report measure of depressive symptoms with a score range of 0 (no depressive symptoms) to 54 (severe depressive symptoms.|Over the past 2 weeks.|||units on a scale||Standard Deviation|Mean
171359|NCT00115804|Secondary|The Functional Disability Inventory-parent Version|Consists of the same 15 items as the child version but allows the parent to provide their perception of the child's difficulty in performing daily physical, social, and recreational activities. The score ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."|||units on a scale||Standard Deviation|Mean
171360|NCT00115804|Secondary|The Functional Disability Inventory-child Version|A self-report inventory that assesses patients' ability to perform a variety of daily physical, social, and recreational activities. The scale ranges from 0 (no disability) to 60 (severe disability).|"Over the last few days."|||units on a scale||Standard Deviation|Mean
171361|NCT00115804|Secondary|The Patient Global Impression of Improvement|Measures the patient's impression of improvement since baseline on a scale of 1 (very much better) to 7 (very much worse).|since baseline, at the time of the assessment|||units on a scale||Standard Deviation|Mean
171362|NCT00115804|Secondary|The Clinical Global Impression of Severity|Measures severity of illness at the time of the assessment on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill).|at the time of the assessment|||units on a scale||Standard Deviation|Mean
171363|NCT00115804|Primary|Average Pain Severity Score|"The primary outcome measure was average pain severity on the Pediatric Pain Questionnaire’s 100-mm visual analog scale.~(0=no pain and 100 = severe pain )"|Daily on average in the past week.|6 participants out of 10 screened met entry criteria. Two were terminated due to serious adverse events (SAEs).||mm||Standard Deviation|Mean
171364|NCT00115765|Secondary|Time to Treatment Failure (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the irinotecan stratum|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
171365|NCT00115765|Secondary|Time to Progression (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
171366|NCT00115765|Secondary|Objective Tumor Response Rate (Irinotecan)|Best overall response of complete or partial response within irinotecan stratum|Overall Study|Intention-to-Treat||Participant|||Number
171367|NCT00115765|Post-Hoc|Objective Tumor Response Rate (Mutant KRAS)|Best overall response of complete or partial response in participants treated with irinotecan and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with irinotecan||Participant|||Number
171388|NCT00115063|Secondary|Change in Blood Pressure||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||millimeter of mercury (mm Hg)||Standard Error|Mean
171389|NCT00115063|Secondary|Change in Weight From Baseline in Kilograms (kg)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||kg||Standard Error|Mean
171369|NCT00115765|Post-Hoc|Overall Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median.|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin||Participant|||Number
171370|NCT00115765|Post-Hoc|Overall Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS). Since the measure of dispersion could not be estimated for at least one treatment arm, participant incidence is provided in lieu of the median|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin||Participant|||Number
171371|NCT00115765|Post-Hoc|Progression-free Survival (Mutant KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin||Month||95% Confidence Interval|Median
171372|NCT00115765|Post-Hoc|Progression-free Survival (Wild-type KRAS)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression in groups treated with oxaliplatin and having a wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS)|Overall Study|Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin||Month||95% Confidence Interval|Median
171373|NCT00115765|Secondary|Progression-free Survival (Irinotecan)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
171374|NCT00115765|Secondary|Overall Survival (Irinotecan)|Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm.|Overall study|Intention-to-Treat||Participant|||Number
171375|NCT00115765|Primary|Objective Tumor Response Through Week 12 (Irinotecan)|Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum|Overall Study|Intention-to-Treat||Participant|||Number
171376|NCT00115765|Secondary|Time to Treatment Failure (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum.|Overall study|Intention-to-Treat||Month||95% Confidence Interval|Median
171377|NCT00115765|Secondary|Time to Progression (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum|Overall Study|Intention-to-Treat||Month||95% Confidence Interval|Median
171378|NCT00115765|Secondary|Objective Tumor Response Rate (Oxaliplatin)|Best overall response of complete or partial response within oxaliplatin stratum|Overall study|Intention-to-Treat||Participant|||Number
171379|NCT00115765|Secondary|Overall Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin|Overall study|Intention-to-Treat||Month||95% Confidence Interval|Median
171380|NCT00115765|Primary|Progression-Free Survival (Oxaliplatin)|Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression|Overall study|Intention-to-Treat||Month||95% Confidence Interval|Median
171381|NCT00115739|Secondary|6 Month Survival Rate|The percentage of patients still alive at 6 months was estimated.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.||percentage of patients||95% Confidence Interval|Number
171382|NCT00115739|Secondary|6 Month Progression Free Survival Rate|The percentage of patients with 6 months progression-free survival was estimated. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, the appearance of new lesions, or the significant clinical deterioration related to progression of patient's disease.|6 months|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.||percentage of patients||95% Confidence Interval|Number
171383|NCT00115739|Secondary|Rate of Grade 3, Grade 4 and Grade 5 Toxicities Experienced by Patients With Anaplastic Thyroid Cancer Who Are Treated With Gleevec|Number of grade 3, grade 4 and grade 5 toxicities experienced by patients with anaplastic thyroid cancer who are treated with Gleevec.|Up to 30 days post treatment|Patients receiving at least one dose of imatinib were included in toxicity analysis.||events|||Number
171384|NCT00115739|Primary|Overall Response (Complete and Partial Response) Rate at 8 Weeks|The number of patients with Complete Response (CR), Partial Response (PR) and Stable Disease (SD) were determined at 8 weeks.|8 weeks|Eight patients completed 8 weeks of imatinib and were considered evaluable for response.||participants|||Number
171385|NCT00115063|Secondary|Change in Duke Activity Status Index (DASI) Questionnaire Score|The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions.|Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||units on a scale||Standard Error|Mean
171386|NCT00115063|Secondary|Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||mg/dL||Standard Error|Mean
171387|NCT00115063|Secondary|Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid||Baseline, 2 years|This analysis was done on the completers, those that completed the 2 year study visit.||Percent change||Standard Error|Mean
171397|NCT00114972|Secondary|Freedom From MACCE and Its Components at 1 Year Post-allocation.|Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).|1 year post allocation|||participants|||Number
171398|NCT00114972|Secondary|Individual Components of MACCE at 1 Year Post-allocation.|Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 year post allocation|ITT analysis||participants|||Number
171399|NCT00114972|Secondary|Individual Components of MACCE at 6 Months Post-allocation.|Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|6 months post allocation|ITT analysis||Participants|||Number
171400|NCT00114972|Secondary|Individual Components of MACCE at 1 Month Post-procedure.|Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.|1 month after procedure|ITT analysis||participants|||Number
171401|NCT00114972|Secondary|Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.|Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.|1 month after procedure and 6 months, 3 years, and 5 years post allocation|||participants|||Number
171402|NCT00114972|Primary|12-month Composite Safety Endpoint.|Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.|12 months after enrollment|||participants|||Number
171403|NCT00114972|Primary|Primary Clinical Endpoint of 12-Month Binary MACCE.|Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).|12 months post enrollment|ITT analysis. Number of participants analyzed equals number of subjects who completed Overall Study, as listed in Participant Flow.||participants|||Number
171404|NCT00114959|Secondary|Participants With Complete Hematologic Remission Suppression of the Philadelphia Chromosome|"Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as:~No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%"|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.|||||
171405|NCT00114959|Primary|Number of Participants With Adverse Experiences (AEs)|"Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments.~A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:~Results in death;~Is life threatening;~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Is medically important.~The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related."|up to 3 years|All treated participants||participants|||Number
171406|NCT00114959|Primary|Proportion of Participants With Chronic Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics.~A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells < 10*10^9/L, absolute neutrophil count >=1*10^9/L, platelets >=100*10^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.|||||
171407|NCT00114959|Primary|Proportion of Participants With Accelerated Phase or Blast Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response|"Participants in accelerated or blast phase who converted to at least CML-chronic phase.~CML in accelerated phase meets one or more of the following criteria: >=15% - <30% blasts in peripheral blood or bone marrow, >=30% blasts + promyelocytes in peripheral blood or bone marrow, >=20% basophils in peripheral blood; platelet count <100*10^9/L unrelated to therapy or clonal evolution. CML in blast phase have >=30% blasts in the bone marrow or presence of extramedullary disease.~Meaningful responses include (in descending order of health)~Complete Hematologic Remission (CHR)~Partial Hematologic Remission (PHR)~Hematologic Improvement (HI)~Partial Response (PR)~Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts <15%, peripheral blasts and promyelocytes <30%, peripheral basophils <20%, and platelets >100*10^9/L."|up to month 4|No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.|||||
171408|NCT00114634|Secondary|ABC Total Score|ABC total score includes all the questions from subscales, with range of 0 to 174. Higher the score , the greater the problem.|2 weeks|||units on a scale||Standard Error|Mean
171409|NCT00114634|Secondary|ABC Inappropriate Behavior Sub-scale|ABC Subscale V (Inappropriate speech) has 4 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 12.|2 weeks|||units on a scale||Standard Error|Mean
171410|NCT00114634|Secondary|ABC Stereotypy Sub-scale|ABC Subscale III (Stereotypy) has 7 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 21.|2 weeks|||units on a scale||Standard Error|Mean
175796|NCT00071760|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
171411|NCT00114634|Secondary|ABC Lethargy Sub-scale|ABC Subscale II (Lethargy) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, 1 the problem is the behavior but slight in degree,2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48.|2 weeks|||units on a scale||Standard Error|Mean
171412|NCT00114634|Secondary|ABC Irritability Sub-scale|ABC Subscale I (Irritability) has 15 items, each can be rated from 0 to 3, with 0 equal to not at all a problem, 1 the problem is the behavior but slight in degree, 2 the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 45|2 weeks|||units on a scale||Standard Error|Mean
171413|NCT00114634|Primary|Hyperactivity Sub-scale of the Aberrant Behavior Checklist-Community (ABC-C).|The Aberrant Behavior Checklist-Community (ABC-C) is a measure used to identify treatment efficacy among intellectually impaired individuals. ABC Subscale IV (Hyperactivity) has 16 items, each can be rated from 0 to 3, with 0 equal to not at all a problems, one the problem is the behavior but slight in degree, to the problem is moderately serious, 3 the problem is severe in degree. For this subscale, score can go from 0 - 48. The higher the score, the worse the hyperactivity. The comparison in this study was made between the blinded phases when patients received either egg yolk (treated, +cholesterol) or egg substitute (untreated, -cholesterol). Order was randomized.|2 weeks|||units on a scale||Standard Error|Mean
171414|NCT00114504|Secondary|Circulating Inflammation Marker|Change in circulating hsCRP levels|Baseline, 3 months|||mg/dL||Standard Deviation|Mean
171415|NCT00114504|Primary|Plaque Inflammation|Change in plaque inflammation was assessed by changes in the plaque SUV.|Baseline, 3 months|||SUV||Standard Deviation|Mean
171416|NCT00114244|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier by arm. The probability of progression-free survival at 3 months and overall survival at 6 months, and their Greenwood’s standard errors will be summarized by arm.|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 3 months|||Months||95% Confidence Interval|Median
171417|NCT00114244|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier by arm.|From first day of treatment to time of death due to any cause, assessed up to 6 months|||Months||95% Confidence Interval|Median
171418|NCT00114244|Primary|Objective Response (OR = CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan, MRI, X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 6 weeks.|||participants|||Number
171419|NCT00114166|Secondary|Reason Off Study Therapy||study entry through end of study treatment|Total number of eligible and evaluable participants||participants|||Number
171420|NCT00114166|Primary|Frequency and Severity of Observed Adverse Effects||Study entry through disease progression or study withdrawal||||||
171421|NCT00114166|Primary|Objective Tumor Response|"Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal|Total number eligible and evaluable participants||participants|||Number
171422|NCT00114127|Secondary|CGI-S|"The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).~Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6."|6 months|||Scores on a scale||Standard Error|Mean
171423|NCT00114127|Primary|Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale|The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.|6 months|||Scores on a scale||Standard Error|Mean
171424|NCT00114101|Post-Hoc|Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy|Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.|Duration of study (up to 10 years)|||participants|||Number
171425|NCT00114101|Other Pre-specified|Overall Survival|Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|||months||95% Confidence Interval|Median
171426|NCT00114101|Secondary|Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100|"Response was defined according to International Myeloma Working Group criteria (2006)~Complete Response: Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Partial Response: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels~Marginal Response: 25-49% reduction in serum M-component & urine M-component by 50-89% which still exceeds 200mg/24hour~Progressive Disease: Defined in primary outcome measure~Stable Disease: Not meeting any of the criteria above"|Day 100|||participants|||Number
171546|NCT00113490|Secondary|Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations|Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.||participants|||Number
175797|NCT00071760|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
171427|NCT00114101|Primary|Time to Progression|"Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.~Progression was defined per the International Myeloma Working Group definition as one more of the following:~25% increase in serum M-component (absolute increase >= 0.5g/dl)~25% increase in urine M-component (absolute increase >= 200mg/24hour~25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~25 % increase in bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas~Development of hypercalcemia"|Duration of study (up to 10years)|||months||95% Confidence Interval|Median
171428|NCT00113022|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a measure of depression severity examined on a weekly basis. The minimum score on the 10 item scale is 0 indicating no depression. The maximum score is 60 indicating a very severe depression. Scores of 18 and above are generally considered to suggest significant levels of depression.|8 weeks|||Scores on a scale||Standard Error|Least Squares Mean
171429|NCT00113919|Secondary|Response Rate (CR, NCR) and Overall Survival of Patients on Busulfex Treatment|Response rate (CR, NCR) and overall survival of patients on Busulfex treatment compared to patients with similar characteristics on other regimens.|three years||||||
171430|NCT00113919|Primary|Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients|maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are > or = 65 years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine clearance < 30 ml/min|three years||||||
171431|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 14 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age||Percentage of FluMist recipients|||Number
171432|NCT00113880|Secondary|Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)||Within 2-3 days of vaccination|Subsets of FluMist recipients 5-8, 9-17, and 18-49 years of age||Percentage of FluMist recipients|||Number
171433|NCT00113880|Secondary|Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls|Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.|180 days|Analyses were performed by period (180 days) and age group (5-8, 9-17, 18-49 years of age), post Dose 1. recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance was observed for any hospitalization or death, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
171434|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
171435|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to Unvaccinated Controls. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to Unvaccinated Controls.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
171436|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in TIV recipients within 42 days. There was no significant decreased risk in comparison to unvaccinated controls within the 42-day timeframe.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
171437|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls|Incident rate comparisons of MAEs with an identified increased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in unvaccinated recipients. There was no increased risk at 3 or 21 days and there was no increased risk compared to the Within Cohort or TIV control groups.|42 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
171547|NCT00113490|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|Assessments of SAEs were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.||participants|||Number
171438|NCT00113880|Secondary|Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls|Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.|21 days|Analyses performed by period (3, 21, and 42 days), age group (5-8, 9-17, 18-49 years of age), and setting (clinic, hospital, or ED), post Doe 1. FluMist recipients who were part of the main analysis and received FluMist in both the current and the immediate prior season(s) were included in this analysis. Significance observed across all settings.||Cases per 1,000 person-months|Participants||Number
171439|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospital/death setting 180 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
171440|NCT00113880|Primary|Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls|Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.|180 days|Analyses were performed by period (180 days), age group (5-8, 9-17, 18-49 years of age), and number of doses (one or two for ages 5-8 years). Significance was observed in the hospitalization/death setting, 180 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
171441|NCT00113880|Primary|Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
171442|NCT00113880|Primary|Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group|Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the any/death setting, 21 and 42 days post Dose 1, for all ages and 18-49.||Cases per 1,000 person-months|Participants||Number
171443|NCT00113880|Primary|Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). significance was observed for encephalitis/encephalopathy, for all age groups, across all settings within 42 days, PD1.||Cases per 1,000 person-months|Participants||Number
171444|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/RAD, wheezing/shortness of breath (SOB), and any ashtma or wheezing event across all settings, PD1 (all age groups) and PD2.||Cases per 1,000 person-months|Participants||Number
171445|NCT00113880|Primary|Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.|180 days|Analyses performed by period (180 days), age group (5-8, 9-17, 18-49 yrs), setting (clinic, hospital, or ED), and number of doses (1 or 2 for 5-8 yrs). Significance was observed for asthma/reactive airway disease (RAD) and any ashtma or wheezing event across all settings, PD1 (all ages and 9-17 yrs) and PD2 (5-8 yrs).||Cases per 1,000 person-months|Participants||Number
171446|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days and 42 days (all age groups) and post Dose 2 (PD2) within 42 days (5-8 yrs).||Cases per 1,000 person-months|Participants||Number
171548|NCT00113490|Secondary|Number of Subjects Reporting Adverse Events (AEs)|Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol.|Day 0 through 30 days post final dose|All subjects who received any study drug were included in all summaries of safety.||participants|||Number
171447|NCT00113880|Primary|Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups|Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed across all settings, post Dose 1 within 21 days for within cohort and within 42 days for unvaccinated.||Cases per 1,000 person-months|Participants||Number
171448|NCT00113880|Primary|Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.|There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).||Cases per 1,000 person-months|Participants||Number
171449|NCT00113880|Primary|Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.|3 days|Analyses were performed by period (3 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years).||Cases per 1,000 person-months|Participants||Number
171450|NCT00113880|Primary|Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.|21 and 42 days|Analyses performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (1 or 2 for ages 5-8 years). Significance observed in the clinic, 21 days post Dose 1 in 1 subj. (heart murmur, all ages combined); 18 and 19 subj.(pregnancy exam, 18-49 and all ages combined).||Cases per 1,000 person-months|Participants||Number
171451|NCT00113880|Primary|Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups|An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.|21 and 42 days|Analyses were performed by period (21 and 42 days), age group (5-8, 9-17, 18-49 years of age), setting (clinic, hospital, or ED), and number of doses (one or two for ages 5-8 years). Significance was observed in the clinic setting, 21 days post Dose 1 in 7 subjects (breast lump/cyst, 9-17 yrs) and in 22 subjects (mastitis, 18-49 yrs).||Cases per 1,000 person-months|Participants||Number
171452|NCT00113841|Primary|Percent Change of NF-kB Protein Expression in Peripheral Blood Mononuclear Cells From Baseline Through 4 Weeks of Treatment|Percent change of NF-kB =[(expression at 4 weeks- expression at baseline)/expression at baseline]*100%. Bone marrow aspirate/biopsy for expression of NF-kB and related genes/proteins markers at baseline and after 4 weeks.|Baseline through 4 weeks of treatment|All participants in the two arms (Curcumin versus Curcumin plus Bioperine) who received at least 4 weeks of treatment were eligible for outcome evaluation.||Percent reduction||Standard Deviation|Mean
171453|NCT00113763|Post-Hoc|Progression-free Survival Time (Mutant KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with mutant KRAS was 24.4 weeks in the panitumumab plus BSC group and 23.9 weeks in the BSC alone group.|Mutant KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||weeks||95% Confidence Interval|Median
171454|NCT00113763|Post-Hoc|Progression-free Survival Time (Wild-type KRAS)|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression among participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time in patients with wild-type KRAS was 36.8 weeks in the panitumumab plus BSC group and 35.7 weeks in the BSC alone group.|Wild-type KRAS Efficacy Analysis Set, a subset of the Intention-to-Treat set with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) status.||weeks||95% Confidence Interval|Median
171557|NCT00113425|Primary|Change From Baseline in Acne Severity at Week 10|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 10|||units on a scale||95% Confidence Interval|Mean
171558|NCT00113425|Primary|Change From Baseline in Erythematous Macules at Week 10||Baseline and Week 10|||erythematous macules||95% Confidence Interval|Mean
171455|NCT00113763|Secondary|Duration of Stable Disease|Kaplan-Meier estimate of the median time from randomization to date of first observed progression of disease or death due to progression of disease (whichever comes first) for those participants with a best response of stable disease. Stable disease defined as neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir longest diameter since the treatment started, no unequivocal progression of existing non-target lesions, and no new lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Participants who had a best overall response of stable disease||weeks||95% Confidence Interval|Median
171456|NCT00113763|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of the median time from randomization to the date the decision was made to end treatment for any reason.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)||weeks||95% Confidence Interval|Median
171457|NCT00113763|Secondary|Time to Disease Progression|Kaplan-Meier estimates of median time from randomization to disease progression or death due to disease progression (whichever occurs first)|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat||weeks||95% Confidence Interval|Median
171458|NCT00113763|Secondary|Time to Response|Time to response was defined as the time from randomization to first partial or complete response, subsequently confirmed ≥ 4 weeks after the criteria for response were first met.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT) participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.||weeks||Inter-Quartile Range|Median
171459|NCT00113763|Secondary|Duration of Response|Kaplan-Meier estimate of the median time from first confirmed objective tumor response to first observed progression of disease or death due to progression of disease (whichever comes first).|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat participants who had a confirmed objective tumor response. No objective tumor responses were observed in the BSC alone treatment arm.||weeks||95% Confidence Interval|Median
171460|NCT00113763|Secondary|Objective Tumor Response|Defined as the number of participants with a confirmed complete or partial tumor response, confirmed by a scan no less than 4 weeks after the criteria for response were first met. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): disappearance of all target lesions, and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, with no progressive disease of non-target lesions.|From randomization until the data cutoff of 15 March 2007. The median follow-up time was 29.6 weeks in the panitumumab plus BSC group and 31.8 weeks in the BSC alone group.|Intention-to-treat (ITT)||participants|||Number
171461|NCT00113763|Secondary|Overall Survival|Kaplan-Meier estimates of median time from randomization to death.|From randomization until the data cut-off date for overall survival of 15 March 2006. The median actual follow-up time was 30 weeks for the panitumumab plus BSC group and 31 weeks for the BSC alone group.|Intention-to-treat (ITT)||months||95% Confidence Interval|Median
171462|NCT00113763|Primary|Progression-free Survival Time|Kaplan-Meier estimates of median time from randomization to either death or first observed disease progression, whichever occurred first. Participants were evaluated for tumor response according to modified Response Evaluation Criteria in Solid Tumors (RECIST) based on the response assessment from a blinded review of radiographic scans by the Independent Review Committee. Progressive disease defined as least a 20% increase in the sum of the longest diameters (SLD) of target lesions, taking as reference the nadir SLD recorded since the treatment started or the appearance of one or more new lesions, or the unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.|Intention-to-treat (ITT)||weeks||95% Confidence Interval|Median
171463|NCT00113607|Secondary|Median Maximum Plasma Concentration (Cmax) of Trabectedin.|Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.||pg/mL|||Number
171464|NCT00113607|Secondary|Median Area Under Curve (AUC) of Trabectedin.|Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.|Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2|Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.||ng*h/mL|||Number
171559|NCT00113425|Primary|Change From Baseline in Open Comedones at Week 10||Baseline and Week 10|||open comedones||95% Confidence Interval|Mean
171560|NCT00113425|Primary|Change From Baseline in Closed Comedones at Week 10||Baseline and Week 10|||closed comedones||95% Confidence Interval|Mean
171561|NCT00113425|Primary|Change From Baseline in Cysts at Week 10||Baseline and Week 10|||cysts||95% Confidence Interval|Mean
171465|NCT00113607|Secondary|Duration of Response: Independent Radiologist Review|Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.|From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years|All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study.||Months||95% Confidence Interval|Median
171466|NCT00113607|Secondary|Objective Response Rate (ORR) - Independent Radiologist Review|Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not.||Percentage of participants|||Number
171467|NCT00113607|Secondary|Overall Survival|Overall survival was defined as the time between the randomization and death|From the date of randomization until the date of death, as assessed for approximately 3 years|All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not||Months||95% Confidence Interval|Median
171468|NCT00113607|Primary|Progression-Free Survival (PFS): Independent Radiologist Review|PFS is defined as the time between randomization and disease progression or death.|From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years|All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan.||Months||95% Confidence Interval|Median
171469|NCT00113568|Primary|Number of Subjects Who Died During the Study|Number of subjects who died, for any reason, during the study|Up to 27 menstrual cycles|||participants|||Number
171470|NCT00113568|Primary|Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study|Examples include deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, central retinal artery and vein obstruction.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
171471|NCT00113568|Primary|Number of Subjects With Adverse Events That Led to Discontinuation From the Study|The total number of subjects who withdrew from the study due to an adverse event irrespective of the causal relation between the AE and the study drug as determined by the investigator|Up to 27 menstrual cycles|||participants|||Number
171472|NCT00113568|Primary|Number of Subjects With at Least One Life-Threatening Adverse Event During the Study|A life-threatening AE is any AE that places the subject at immediate risk of death from the event as it occurred.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
171473|NCT00113568|Primary|Number of Subjects With at Least One Serious Adverse Event During the Study|A serious adverse event (SAE) is any adverse event (AE) occurring at any dose that meets 1 or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity; results in cancer; results in a congenital anomaly or birth defect. Important medical events not described above may be considered SAEs when based on appropriate medical judgment.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
171474|NCT00113568|Primary|Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A definitely treatment-related adverse event is an event that can be fully explained by administration of the study drug.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
171475|NCT00113568|Primary|Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
171476|NCT00113568|Primary|Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study|The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
171477|NCT00113568|Primary|Number of Subjects With at Least One Adverse Event During the Study|An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.|Up to 27 menstrual cycles|intent to treat population||participants|||Number
171478|NCT00113529|Secondary|Ctrough of Gefitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.||ng/mL||Standard Deviation|Mean
171479|NCT00113529|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|PK = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.||ng/mL||Standard Deviation|Mean
171480|NCT00113529|Secondary|Trough Plasma Concentrations (Ctrough) of Sunitinib||prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)|Pharmacokinetic (PK) = the ITT population of subjects who had completed PK blood sampling for at least one day. n=number of subjects with trough plasma concentrations at the specified time point.||ng/mL||Standard Deviation|Mean
171481|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171482|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171483|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171484|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median|Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for TTP (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171485|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171486|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171487|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171488|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median|Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects evaluable for PFS (ie, those who died or had tumor progression) with baseline biomarker values. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171489|NCT00113529|Secondary|Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171490|NCT00113529|Secondary|Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171491|NCT00113529|Secondary|Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171492|NCT00113529|Secondary|Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)|Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||pg/mL|||Number
171493|NCT00113529|Secondary|sVEGFR3 Ratio to Baseline at Each Time Point|sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
171494|NCT00113529|Secondary|Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline|Concentration of sVEGFR3 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
171495|NCT00113529|Secondary|sVEGFR2 Ratio to Baseline at Each Time Point|sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
171496|NCT00113529|Secondary|Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline|Concentration of sVEGFR2 at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
171497|NCT00113529|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
171498|NCT00113529|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
171499|NCT00113529|Secondary|VEGF Ratio to Baseline at Each Time Point|VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).|Baseline to Cycle 3, Day 28 inclusive|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
171500|NCT00113529|Secondary|VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline|Concentration of VEGF at baseline.|Baseline (Cycle 1, Day 1)|ITT. Number of participants analyzed = number of subjects with soluble protein biomarkers at baseline.||pg/mL||Standard Deviation|Mean
171501|NCT00113529|Secondary|Probability of Survival at One Year|Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year|ITT||probability|||Number
171502|NCT00113529|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death|ITT. Number of participants analyzed = those who progressed or died due to any cause while on study.||weeks||95% Confidence Interval|Median
171503|NCT00113529|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used.|From start of study treatment until death|ITT. Number of participants analyzed = subjects who died.||weeks||Full Range|Median
171504|NCT00113529|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who progressed on study.||weeks||95% Confidence Interval|Median
171505|NCT00113529|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer|ITT. Number of participants analyzed = those who had a response and subsequent progression or death due to any cause while on study.||weeks||Full Range|Median
171506|NCT00113529|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|ITT. Number of participants analyzed = those who had a confirmed response on study.||weeks||95% Confidence Interval|Median
171507|NCT00113529|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter|Intent-to-treat (ITT) = all subjects enrolled in the study that received at least 1 dose of study medication (sunitinib or gefitinib).||participants|||Number
171508|NCT00113516|Secondary|Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)|QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.||scores on a scale||Standard Error|Mean
171509|NCT00113516|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)|EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.|Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2|ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.||scores on a scale||Standard Error|Mean
171510|NCT00113516|Secondary|Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib|A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized.|Within 7 days of Day 1|c-Kit, Flt-3 and c-Fms to safety of Sunitinib samples were collected and analyzed. However, there was no statistics performed since power was insufficient.||pg/mL|||Number
171511|NCT00113516|Secondary|Immunohistochemical Staining of Paraffin Embedded Tumor Tissue|Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.|Screening|Samples were collected and stained from a subset of subjects. Due to the small sample size, no correlative analyses with clinical outcome were conducted.||samples|||Number
171512|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), Cycle 4, Day 28 (< median cutpoint, > = median cutpoint)and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.||months||95% Confidence Interval|Median
171513|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.||months||95% Confidence Interval|Median
171549|NCT00113490|Primary|Number of Subjects Exhibiting Anti-motavizumab Antibodies|Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.|Day 0 through 120 days post final dose|All subjects who received any study drug were included in all summaries of immunogenicity. Day 0 n=66 mota, n=70 pali; Day 25-30 n=65 mota, n=69 pali; Day 120 n=64 mota, n=67 pali; 30 days post final dose n=65 mota, n=67 pali; 90-120 days post final dose n=64 mota, n=67 pali; at any time n=66 mota, n=70 pali.||participants|||Number
171514|NCT00113516|Secondary|Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline|OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (< median cutpoint), median and/or CI were not able to be estimated.||months||95% Confidence Interval|Median
171515|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
171516|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint), and Cycle 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
171517|NCT00113516|Secondary|Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
171518|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.|[Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (> = median cutpoint), Cycle 3, Day 28 (< median cutpoint), and Cycles 4 and 5, Day 28 (< median cutpoint, > = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
171519|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (< median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
171520|NCT00113516|Secondary|Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline|PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point.|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (< median cutpoint) and Cycle 5, Day 28 (> = median cutpoint), median and/or CI were not able to be estimated.||weeks||95% Confidence Interval|Median
171550|NCT00113425|Secondary|Change From Baseline in Acne Severity at Week 16|The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.|Baseline and Week 16|||units on a scale||95% Confidence Interval|Mean
171521|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 4, Day 28 and Cycle 5, Day 28.||ratio|||Number
171522|NCT00113516|Secondary|Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL|||Number
171523|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.||ratio|||Number
171524|NCT00113516|Secondary|VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL|||Number
171525|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.||ratio|||Number
171526|NCT00113516|Secondary|VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)|Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).|Baseline (Cycle 1, Day 1) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.||pg/mL|||Number
171527|NCT00113516|Secondary|Soluble E-Selectin Ratio to Baseline at Each Time Point|Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. At Cycle 4, Day 28, median and/or standard deviation were not able to be estimated.||ratio||Standard Deviation|Mean
171528|NCT00113516|Secondary|Soluble E-Selectin at Baseline|Concentration of soluble E-Selectin at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with soluble E-Selectin data at Baseline.||nanograms (ng)/mL||Standard Deviation|Mean
171529|NCT00113516|Secondary|VEGF-C Ratio to Baseline at Each Time Point|VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
171530|NCT00113516|Secondary|VEGF-C Concentration at Baseline|Concentration of VEGF-C at baseline.|Baseline (Cycle 1, Day 1) of Part 2|MITT. Number of participants analyzed = number of subjects with VEGF-C data at Baseline.||pg/mL||Standard Deviation|Mean
171531|NCT00113516|Secondary|VEGFR3 Ratio to Baseline at Each Time Point|VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).|Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2|MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.||ratio||Standard Deviation|Mean
171532|NCT00113516|Secondary|Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline|Concentration of VEGFR3 at baseline.|Baseline (Cycle 1, Day 1) of Part 2|Modified ITT population (MITT) = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin and at least 1 dose of Sunitinib.||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
171533|NCT00113516|Secondary|Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
171551|NCT00113425|Secondary|Change From Baseline in Erythematous Macules at Week 16||Baseline and Week 16|||erythematous macules||95% Confidence Interval|Mean
171552|NCT00113425|Secondary|Change From Baseline in Open Comedones at Week 16||Baseline and Week 16|||open comedones||95% Confidence Interval|Mean
171534|NCT00113516|Secondary|Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
171535|NCT00113516|Secondary|Dose-Corrected Ctrough of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
171536|NCT00113516|Secondary|Ctrough of Total Drug (Sunitinib + SU-012662)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
171537|NCT00113516|Secondary|Ctrough of SU-012662 (Sunitinib's Metabolite)|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|PK. Subjects with plasma values below limit of quantification were excluded.||ng/mL||Standard Deviation|Mean
171538|NCT00113516|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib|Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.|predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2|Pharmacokinetic (PK) = all subjects enrolled in the study who received at least 1 dose of carboplatin/paclitaxel or sunitinib. Subjects with plasma values below limit of quantification were excluded.||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
171539|NCT00113516|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death − date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.|From start of study treatment until death|ITT||months||95% Confidence Interval|Median
171540|NCT00113516|Secondary|Number of Subjects With Overall Confirmed Objective Disease Response|Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT||participants|||Number
171541|NCT00113516|Secondary|Duration of Response (DR)|DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR – first CR or PR that was subsequently confirmed +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT. DR was calculated for the subgroup of subjects with objective response. 23 subjects reported CR or PR response and were analyzed for DR.||weeks||95% Confidence Interval|Median
171542|NCT00113516|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date – first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)|ITT||weeks||95% Confidence Interval|Median
171543|NCT00113516|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.|From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death|ITT||weeks||95% Confidence Interval|Median
171544|NCT00113516|Primary|Proportion of Subjects Surviving at One Year|Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.|From start of treatment until 1 year or death|Intent-to-treat (ITT) population = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin.||proportion|||Number
171545|NCT00113490|Secondary|Motavizumab Serum Concentrations at Each Data Collection Visit|Mean serum concentration.|Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose|All subjects who received any study drug were included in all summaries. Day 0 n= 66; Day 25-30 n=65; Day 120 n=63; 30 days post final dose n=63; 90-120 days post final dose n=62||ug/mL||Standard Deviation|Mean
171553|NCT00113425|Secondary|Change From Baseline in Closed Comedones at Week 16||Baseline and Week 16|||closed comedones||95% Confidence Interval|Mean
171566|NCT00113373|Secondary|Prognostic Variables: Platinum Sensitivity, Performance Status, and Cellular Histology (Clear Cell or Mucinous Type)|An analysis of any potential treatment effect on PFS or overall survival may be conducted against historical controls using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.|Up to 5 years||||||
171567|NCT00113373|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|Eligible and Treated Patients||months||95% Confidence Interval|Median
171568|NCT00113373|Secondary|Duration of Progression-free Survival|An analysis of any potential treatment effect on PFS or overall survival may be conducted against historical controls using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.|From study entry until disease progression, death or date of last contact, assessed up to 5 years||||||
171569|NCT00113373|Secondary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
171570|NCT00113373|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0||Up to 5 years||||||
171571|NCT00113373|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
171572|NCT00113360|Primary|Progression Free Survival (PFS)|PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.|PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicated|Per protocol||Weeks||95% Confidence Interval|Median
171573|NCT00113334|Primary|Response Rate|Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): >20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon’s optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.|Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.|Three (3) patients were inevaluable for response.||participants|||Number
171574|NCT00113321|Primary|Overall Response|Participants with Overall Response, categorized as 'Complete Response' to represent remission or 'No Complete Response' for lack of remission. Response evaluation after completing one course of therapy (8-12 weeks), then bone marrow aspiration to document remission every 1-3 courses.|Blood tests baseline and after completing 8-12 weeks of therapy|Treated population (16 patients); No further analysis done since study terminated early due to low accrual.||Participants|||Number
171575|NCT00113295|Secondary|The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).|The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is used to assess quality of life changes with treatment. Total scores range from 14-70, with higher levels of satisfaction yielding higher scores.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)|||units on a scale||Standard Deviation|Mean
171576|NCT00113295|Secondary|Depressive Symptoms, Montgomery–Asberg Depression Rating Scale (MADRS)|Depressive symptoms were measured at a secondary outcome using the Montgomery–Asberg Depression Rating Scale (MADRS). Each item is scored on a scale of 1-6; The total score range is 0-60, with higher scores indicated higher levels of depression severity.|Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)|||units on a scale||Standard Deviation|Mean
171577|NCT00113295|Secondary|Response, Clinical Global Impression of Improvement (CGI-I)|Response was measured as a secondary outcome using the Clinical Global Impression of Improvement (CGI-I). Response was defined as a score of 1 [“very much improved”] or 2 [“much improved”] at study endpoint.|Week 18 (Phase 2 Endpoint)|||participants|||Number
171578|NCT00113295|Primary|Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.|"Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint.~The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD."|Baseline and Week 18|Twenty-two patients were randomized, 11 to quetiapine and 11 to placebo augmentation, and all had at least one assessment postrandomization and were included in the phase 2 efficacy analyses; of this group, six randomized to quetiapine (54.5%) and ten to placebo (90.1%) completed the trial.||units on a scale||Standard Deviation|Mean
171579|NCT00113295|Secondary|Remission (HAM-A ≤ 7)|Remission was measured as a secondary outcome using a score of less than or equal to 7 on the Hamilton Anxiety Scale (HAM-A).|Week 18 (Study Endpoint)|||participants|||Number
171580|NCT00113269|Secondary|Renal Function Abnormalities Based on Serum Creatinine|"Decrease in serum creatinine usually indicates an improvement.~Change in creatinine clearance from month 1 was calculated.~Change from 1 month is calculated by month 36 – month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.||mcmol/L||Standard Deviation|Mean
171581|NCT00113269|Secondary|Renal Function Abnormalities Based on Creatinine Clearance|"Increases in creatinine clearance usually indicates an improvement.~Change in creatinine clearance from month 1 was calculated.~Change from 1 month is calculated by month 36 – month 1."|1 month and End of Study (36 months)|The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as “N”.||mL/s||Standard Deviation|Mean
171582|NCT00113269|Secondary|Overall Patient Survival|"Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
171583|NCT00113269|Secondary|Patient Survival at 12 Months|"Patient survival is defined as not dead within 12 months after skin closure.~Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
171584|NCT00113269|Secondary|Overall Graft Survival|"Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
171585|NCT00113269|Secondary|Graft Survival at 12 Months|"Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.~Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first."|12 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
171586|NCT00113269|Secondary|Time to First BCAR|"Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|"The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.~Only patients who experienced BCAR were included in the analysis."||Days||Full Range|Median
171587|NCT00113269|Secondary|Clinically Treated Acute Rejection|"Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
171588|NCT00113269|Secondary|Efficacy Failure|"Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
171589|NCT00113269|Secondary|Overall Patient Incidence of BCAR|"Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).~End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months."|End of Study (36 months)|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients|||Number
171590|NCT00113269|Primary|Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months|"A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).~Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st."|6 months|The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.||Percentage of Patients||95% Confidence Interval|Number
172032|NCT00109876|Primary|Overall Survival at 2 Years|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration|All enrolled participants who met the eligibility criteria.||percentage of participants||95% Confidence Interval|Number
171591|NCT00113230|Primary|Pathologic Local Tumor Response|At follow-up evaluation after completion of neoadjuvant and surgical therapy, resected primary tumor classified based on routine pathology staining in the following manner: Pathologic Complete Response (no evidence of residual cancer); Microscopic Residual (no grossly detected disease, but evidence of microscopic residual disease); and Gross Residual Disease.|Baseline to approximately 5 Months (Following 28 days of treatment, chemotherapy and surgical resection of tumor)|Intention to treat analysis method. Data examination conducted upon enrollment and evaluability of 25 patients.||Participants|||Number
171592|NCT00113217|Secondary|Safety of Treatment|Safety measured by participant toxicities in therapy with bevacizumab for Renal Cell Carcinoma (RCC).|Following 56 days treatment||||||
171593|NCT00113217|Primary|Progression Free Survival (PFS)|Time to progression calculated from the start of the study drug to the first evidence of disease progression. Time to progression reported as PFS measured in months. Progression (or progressive disease) defined by Response Evaluation Criteria in Solid Tumors (RECIST) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 3 years (or until disease progression)|||months||95% Confidence Interval|Median
171594|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with moderate to severe AV valve regurgitation.|at age 14 months|ITT, no imputation||participants|||Number
171595|NCT00113087|Secondary|Number of Participants With Moderate to Severe AV Valve Regurgitation|Number of participants with Moderate to severe AV valve regurgitation.|just before the pre-Glenn surgery|ITT, no imputation||participants|||Number
171596|NCT00113087|Secondary|Ventricular Filling Pressure|Ventricular filling pressure measured by catherization|just before the Glenn surgery|ITT, no imputation||mmHg||Standard Deviation|Mean
171597|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)||g/ml||Standard Deviation|Mean
171598|NCT00113087|Secondary|Ventricular Mass to Volume Ratio|Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.|Measured just before the Glenn surgery|Intention-to-treat analysis of participants completing the pre-Glenn visit||g/ml||Standard Deviation|Mean
171599|NCT00113087|Secondary|End-diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
171600|NCT00113087|Secondary|End Diastolic Volume Z-score|Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||standard deviation||Standard Deviation|Mean
171601|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|at 14 months of age|ITT, no imputation||ml||Standard Deviation|Mean
171602|NCT00113087|Secondary|End-diastolic Volume|Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||ml||Standard Deviation|Mean
171603|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
171604|NCT00113087|Secondary|Ventricular Mass Z-score|Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||standard deviation||Standard Deviation|Mean
171605|NCT00113087|Secondary|Ventricular Mass|Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40|At 14 months of age|ITT, no imputation||g||Standard Deviation|Mean
171606|NCT00113087|Secondary|Ventricular Mass|Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment.|just before the Glenn surgery|ITT, no imputation||g||Standard Deviation|Mean
171607|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction (%) is defined as percentage of stroke volume of a ventricle (i.e. the difference between end diastolic and end systolic volumes)relative to end diastolic volume.|at 14 months of age|ITT, no imputation||percent (of end diastolic volume)||Standard Deviation|Mean
171608|NCT00113087|Secondary|Ejection Fraction (%)|Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction % is defined as the percentage of the stroke volume (i.e. difference between end-diastolic and end-systolic volumes) in a ventricle relative to end-diastolic volume.|just before the Glenn surgery|ITT, no imputation||percent (of end diastolic volume)||Standard Deviation|Mean
171609|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Produced|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score.|at 14 months of age|ITT, no imputation||standard deviation||Inter-Quartile Range|Median
171610|NCT00113087|Secondary|MacArthur-Bates Inventory -Total Gestures|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
171611|NCT00113087|Secondary|MacArthur-Bates Inventory -Words Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
171612|NCT00113087|Secondary|MacArthur-Bates Inventory -Phrases Understood|MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score.|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
171613|NCT00113087|Secondary|Neurodevelopmental Status (FSII)|Functional status II (Revised) Total Score. Scale ranges up to 100.00, the higher the better. The score presents an instrument for assessing health status for children surviving long term with chronic physcial disorders.|at 14 months of age|ITT, no imputation||units on a scale||Inter-Quartile Range|Median
171614|NCT00113087|Secondary|Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score|Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score .|at 14 months of age|ITT, not imputation||standard deviation||Standard Deviation|Mean
171615|NCT00113087|Secondary|Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score|"Neurodevelopmental status (PDI):~the Bayley Scales of Infant Development: Psychomotor Development index z-score ."|at 14 months of age|ITT, no imputation||standard deviation||Standard Deviation|Mean
171616|NCT00113087|Secondary|B-type Natriuretic Peptide Level|B-type natriuretic peptide (BNP) level.|at the time of the 14 month visit|ITT, no imputation||pg/ml||Inter-Quartile Range|Median
171617|NCT00113087|Secondary|B-Type Natriuretic Peptide|B-Type Natriuretic Peptide (BNP) level.|Measured just prior to the Glenn surgery|ITT analysis, no imputation||pg/ml||Inter-Quartile Range|Median
171618|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Measured at 14 months of age|Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months)||participants|||Number
171619|NCT00113087|Secondary|Number of Participants With Ross Heart Failure Class I|Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.|Just prior to the pre-Glenn surgery|Intention-to-treat analysis of participants measured just prior to the Glenn surgery||Participants|||Number
171620|NCT00113087|Secondary|Head Circumference-for-age Z-score|Head circumference-for-age z-score at 14 months of age.In primary analysis outcome is defined as predicted mean of Head circumference z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation||standard deviation||Standard Error|Least Squares Mean
171621|NCT00113087|Secondary|Height-for-age Z-score|Height-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of height z-score at age 14 months based on longitudinal modeling (adjusted bor baseline value)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|||standard deviation||Standard Error|Least Squares Mean
171622|NCT00113087|Primary|Weight-for-age Z-score at 14 Months of Age|Weight-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of weight z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)|Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age|ITT, no imputation||standard deviation||Standard Error|Least Squares Mean
171623|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis|An overall survival event was death due to any cause.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.||participants|||Number
171624|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the clinical cut-off date (30 June 2012) were censored at the date they were last known to be alive.|From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized).|ITT patients with Stage III disease.||months||95% Confidence Interval|Median
171625|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Number of Events|An overall survival event was death due to any cause.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.||participants|||Number
171626|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Number of Events|A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.||participants|||Number
171627|NCT00112918|Secondary|Overall Survival in Stage III Cancer Patients - Time to Event|Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.|From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).|ITT patients with Stage III disease.||months||95% Confidence Interval|Median
171628|NCT00112918|Primary|Disease-free Survival in Stage III Cancer Patients - Time to Event|Disease-free survival (DFS) was defined as the time from the date of randomization to the time of a recurrence, a new occurrence of colorectal cancer or death due to any cause, whichever occurred first. Patients without an event were censored at the last date the patient was known to be disease-free. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Patients with no tumor assessments after baseline but still alive at the time of the clinical cut-off were censored at day 1.|From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).|The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.||months||95% Confidence Interval|Median
171638|NCT00112736|Primary|Progression-free Survival at 6 Months (Phase II)|"Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).~Responses had to be present on 2 consecutive scans and were centrally reviewed."|Evaluated at baseline and every other cycle, till Month 6|Primary endpoint PFS6 date of registration; Sample size chosen to discriminate between 15% & 35% PFS6 rates for GBM patients. With accrual 32 GBM patients, trial would be considered successful if 8 achieved PFS6. This yields 0.92 power to detect a 35% PFS6 rate, with 0.90 probability of rejecting the treatment regimen if the PFS6 rate is only 15%.||participants|||Number
171629|NCT00112905|Secondary|Best Overall Response by RECIST|"This outcome measure reports the best response a patient has ever experienced.~<Target Lesions>~Complete Response (CR):~The disappearance of all target lesions, confirmed by assessments >=4 weeks (wks) later.~Partial Response:~>=30% decrease in the sum of the longest diameters of target lesions from baseline, confirmed by assessments >=4 wks later.~Progressive Disease (PD):~>=20% increase in the sum of the longest diameters of target lesions from the smallest sum longest diameter since baseline, or the appearance of new lesions.~Stable Disease (SD):~Neither response criteria nor progressive disease criteria are met for >=8 wks.~<Nontarget Lesions>~CR:~The disappearance of all nontarget lesions and normalization of tumor marker levels, confirmed by assessments >=4 wks later.~SD:~Persistence of nontarget lesions or maintenance of tumor marker levels above the normal limits for >=8 wks.~PD:~The appearance of new lesions or unequivocal progression of existing lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in the analysis.||Participants|||Number
171630|NCT00112905|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.||Months||90% Confidence Interval|Median
171631|NCT00112905|Secondary|Progression-free Survival|"Time from registration to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Only eligible and treated patients are included in this analysis.||Months||90% Confidence Interval|Median
171632|NCT00112905|Primary|Kaplan-Meier Estimate of Progression-free Survival at 4 Months|"Survival estimate from the Kaplan-Meier curve of the proportion of patients alive and progression-free at 4 months.~Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 1 year.|Per protocol, the primary analysis included eligible patients who started protocol treatment.||Percentage of Participants||90% Confidence Interval|Number
171633|NCT00112840|Secondary|Overall Survival (Phase I and II)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants were used for this endpoint.||months||95% Confidence Interval|Median
171634|NCT00112840|Secondary|Time to Progression (Phase II)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Up to 3 years from study registration|All eligible participants in Phase II were used for this endpoint.||months||95% Confidence Interval|Median
171635|NCT00112840|Secondary|Clinical Best Response Rate of CCI-779 and Bevacizumab in Patients With Metastatic Renal Cell (Phase II)|"The number of participants with clinical tumor response to treatment will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 3 years from study registration|All eligible Phase II patients were used to assess this endpoint.||percentage of participants|||Number
171636|NCT00112840|Primary|Proportion of Progression-free Patients at 6 Months (Phase II)|Determination of progression will be made according to Response Evaluation Criteria in Solid Tumors (RECIST). A progression (PD) is defined as having at least a 20% increase in the sum of the longest dimension of target lesions taking as reference the smallest sum of the largest dimension recorded at baseline.The proportion of progression-free patients will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the success proportion will be calculated. All patients meeting the eligibility criteria who have signed a consent form and begun treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|6 months after study entry|Only Phase II participants were analyzed for this endpoint. Forty participants from Phase II were evaluable for this endpoint.||percentage of participants||95% Confidence Interval|Number
171637|NCT00112840|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria:~Grade 4 Absolute neutrophil count (ANC) for 5+ days.~Grade 4 anemia or thrombocytopenia of any duration.~Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal.~Any other non-hematologic grade 3 or higher as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, except fatigue and grade 3 Hypertension that is will be controlled with oral medication.~Grade 3 triglycerides will be a DLT for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.~The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose where 1 or 0 out of 6 patients experience DLT with the next higher dose."|Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles.|||participants|||Number
171639|NCT00112736|Primary|Pharmacokinetics (Phase I)|"Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels~blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1~Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration"|Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration|per protocol||ng/mL||Standard Deviation|Mean
171640|NCT00112736|Primary|Efficacy - Response Phase 1|"pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan.~Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): >= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer)."|at least 8 weeks of treatment|Response was reviewed only in those patients treated at the MTD (15mg temsirolimus)||participants|||Number
171641|NCT00112736|Primary|Safety/Dose Limiting Toxities Phase I|"Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade >/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy.~MTD defined as dose at which fewer than one-third of patients experienced a DLT~Outcome measure defines number of participants who had a defined dose limiting toxicity."|first 4 weeks of treatment|||participants|||Number
171642|NCT00112736|Primary|Maximum Tolerated Dose (Phase I)|"Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed.~3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg"|based on first 4 weeks of treatment - cycle 1|Per protocol -||mg|||Number
171643|NCT00112723|Secondary|Pharmacokinetics (Cmax) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1|||μM||Standard Deviation|Mean
171644|NCT00112723|Secondary|Pharmacodynamic Effects of Flavopiridol on Normal Peripheral Blood Mononuclear Cells (PBMCs).|The correlation of the pharmacodynamic effects of flavopiridol on normal peripheral blood mononuclear cells (PBMCs)|Day 1|Data not available due to studies were not conducted by collaborating laboratory Investigator|||||
171645|NCT00112723|Secondary|Induced Response in Patients Independent of p53 Mutational Status|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years|Data not available due to studies were not conducted by collaborating laboratory Investigator|||||
171646|NCT00112723|Secondary|Number of Patients Reporting Acute Infusion Toxicity (e.g., Fever, Hypotension, Tumor Pain, and Dyspnea)||Up to 30 days after completion of study treatment|||patients|||Number
171647|NCT00112723|Secondary|Pharmacokinetics (Area Under the Curve; AUC) of Flavopiridol|Whole blood samples were collected for pharmacokinetics analysis during the first (Day 1) and fourth (Day 22) treatments during cycle 1. Samples were collected on both occasions prior to dosing and at 0.5, 1, 3, 4.5, 6, 8 and 24 hour after the start of the bolus infusion.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 22 of Cycle 1|total of 71 PK (Pharmacokinetic) profiles comprising 484 plasma concentration were determined for 45 of 46 patients following treatment||hr×μM||Standard Deviation|Mean
171648|NCT00112723|Primary|Lymphoid/Plasma Cell Malignancies|Identify subsets, based on levels of response (PR and SD), of lymphoid / plasma cell malignancies that are suitable for larger phase II studies designed to further evaluate the efficacy and toxicity of flavopiridol.|Up to 2 years|Response indicated for Indolent B-cell NHL, Mantle cell NHL and T-cell NHL||patients|||Number
171649|NCT00112723|Primary|Qualitative and Quantitative Toxicities in Regard to Organ Specificity|The NCI Common Toxicity Criteria for Adverse Events (version 3.0) were used to define and grade toxicity for patients.|Up to 30 days after completion of study treatment|Grade 3 and 4 toxicities.||percentage of patients|||Number
171650|NCT00112723|Primary|Complete and Partial Response Rate (Phase II)|Patients were assessed for clinical response after two , four and six cycle with laboratory studies, physical exam, and CT scans. Response was evaluated using the modified NCI-sponsored Working Group Lymphoma Response Criteria.|Up to 2 years|Includes patients enrolled with Indolent B-cell NHL, Intermediate Grade B NHL, Mantle cell NHL and T/NK-cell NHL||patients|||Number
171651|NCT00112723|Primary|Maximum Tolerated Dose (MTD)|The maximum tolerated dose (MTD) is defined as that dose level beneath the dose at which 2 or more of 6 patients experience DLT.|28 days|||mg/m2|||Number
171652|NCT00112723|Primary|Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)|Dose limiting toxicity (DLT) for an individual disease group is defined as 1) any grade 3-4 non-hematologic toxicity (except leukopenia or neutropenia) that does not resolve or decrease to grade 1-2 within 2 weeks, or 2) any grade 4 hematologic toxicity that causes more than a 1 week delay in administration of therapy.|28 days|||patients|||Number
171653|NCT00112671|Secondary|Frequency and Severity of Adverse Events|Will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 5 years||||||
171654|NCT00112671|Secondary|Progression-free Survival|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Survival estimates will be computed using the Kaplan-Meier method. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated.|From start of treatment to progression or death, assessed up to 1 year||||||
171776|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 14-28|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171655|NCT00112671|Secondary|Time to Progression|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years|||months||95% Confidence Interval|Median
171656|NCT00112671|Secondary|Rate and Duration of Stable Disease|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated using figures and plots.|From the start of the treatment until the criteria for progression are met, up to 5 years|Stable disease for more than 3 months||participants|||Number
171657|NCT00112671|Primary|Antitumor Activity of BAY 43-9006 Using Objective Tumor Response Rate Defined as Partial or Complete Response by the RECIST Criteria|Summary statistics, such as the mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon tests may be substituted if necessary. 95% confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 5 years|||participants|||Number
171658|NCT00112489|Primary|Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response|"Primary outcome measured according to RECIST v1.0 Best Response:~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (q 6 weeks) until disease progression is documented.|Total eligible and treated participants||participants|||Number
171659|NCT00112489|Primary|Nature and Degree of Toxicity|Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0|During study treatment and up to 30 days after stopping study treatment||||||
171660|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Geometric mean Percentage change from baseline, in Biochemical Marker of bone turnover (serum Cross-Linked Carboxyterminal Telopeptides of Type I Collagen [1-CTP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
171661|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b) [TRAP 5-b]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum Bone tartrate-resistant acid phosphatase isoform 5b [TRAP 5-b]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
171662|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen [s-P1NP]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen [s-P1NP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
171663|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase [s-BSAP]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase [s-BSAP]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
171664|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines [u-DPyr]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines [u-DPyr]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
171665|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen [s-CTx]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen [s-CTx]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
171666|NCT00112437|Secondary|Geometric Mean Percentage Change From Baseline, in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen [u-NTx]) at 36 Months|Geometric Mean Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen [u-NTx]) at 36 Months|Baseline and 36 months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 36 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric Mean Percent Change||95% Confidence Interval|Least Squares Mean
171667|NCT00112437|Secondary|Percentage Change From Baseline in Distal Forearm Bone Mineral Density at 36 Months|Percentage change in Distal Forearm Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
171668|NCT00112437|Secondary|Percentage Change From Baseline in Total Body Bone Mineral Density at 36 Months|Percentage change in Total Body Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
171669|NCT00112437|Secondary|Percentage Change From Baseline in Trochanter Bone Mineral Density at 36 Months|Percentage change in Trochanter Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
171670|NCT00112437|Secondary|Percentage Change From Baseline in Femoral Neck Bone Mineral Density at 36 Months|Percentage change in Femoral Neck Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
171671|NCT00112437|Secondary|Percentage Change From Baseline in Total Hip Bone Mineral Density at 36 Months|Percentage change in Total Hip Bone Mineral Density (relative to baseline) at 36 Months|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
171672|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 36 Months|Percentage change in lumbar spine Bone Mineral Density (relative to baseline) at 36 Months.|Baseline and 36 months|This analysis was performed at Month 36 using the Per-protocol approach which includes patients who took at least one dose of extension study medication and had the necessary follow-up information. Missing values were not imputed. No data were carried forward from month 30 to 36.||Percent Change||95% Confidence Interval|Least Squares Mean
171673|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171674|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171675|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
172717|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
171676|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171677|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 24 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u- NTx)) (relative to baseline) at 24 Months|Baseline and 24 months|Analysis used a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 24 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171678|NCT00112437|Secondary|Percentage Change in Distal Forearm Bone Mineral Density at 24 Months|Percentage change in Distal Forearm Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
171679|NCT00112437|Secondary|Percentage Change in Total Body Bone Mineral Density at 24 Months|Percentage change in total body Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward. No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
171680|NCT00112437|Secondary|Percentage Change in Tronchanter Bone Mineral Density at 24 Months|Percentage change in trochanter Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percent Change||95% Confidence Interval|Least Squares Mean
171681|NCT00112437|Secondary|Percentage Change in Femoral Neck Bone Mineral Density at 24 Months|Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
171682|NCT00112437|Secondary|Percentage Change in Total Hip Bone Mineral Density at 24 Months|Percentage change in total hip Bone Mineral Density (relative to baseline) at 24 Months|Baseline and 24 months|This analysis was performed at Month 24 using Full-Analysis-Set Population with Last Observation Carried Forward (from extension data). No data was carried forward from the core to the extension period.||Percentage change||95% Confidence Interval|Least Squares Mean
171683|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (serum N-terminal propeptide of Type 1 collagen (s-P1NP) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171684|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum Bone-specific Alkaline Phosphatase (s-BSAP)) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (serum bone-specific alkaline phosphatase (s-BSAP)), at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171685|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary Total Deoxypyridinolines (u-DPyr)) at 12 Months|Back-transformation (geometric mean) of the Least Squares Mean of the log-values Percentage change in Biochemical Marker of Bone turnover (urinary total deoxypyridinolines (u-DPyr)) (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was a geometric mean percent change from baseline (back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171686|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Serum C-telopeptides of Type 1 Collagen (s-CTx)) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline in Biochemical Marker of Bone turnover (serum C-telopeptides of Type 1 collagen (s-CTx)) at 12 Months.|Baseline and 12 Months|This analysis was a geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach, where patients with important protocol deviations and major protocol violators were excluded from the analyses The per-protocol approach did not estimate missing data||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171777|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171687|NCT00112437|Secondary|Percentage Change in Biochemical Marker of Bone Turnover (Urinary N-telopeptides of Type I Collagen (u-NTx)) at 12 Months|Back-transformation (geometric mean) of the Least Squares (LS) Mean of the log-values Percentage change from baseline, in Biochemical Marker of Bone turnover (urinary N-telopeptides of Type I collagen (u-NTx)) at 12 Months|Baseline and 12 Months|This analysis was geometric mean percent change from baseline (which is a back-transformation of a log-transformed fraction from baseline) at Month 12 using a Per-Protocol approach where patients with important protocol deviations and major protocol violators were excluded from the analyses. The per-protocol approach did not estimate missing data.||Geometric LS Mean percent change||95% Confidence Interval|Least Squares Mean
171688|NCT00112437|Secondary|Percentage Change in Distal Forearm Bone Mineral Density at 12 Months|Percentage change in Distal Forearm Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward||Percentage change||95% Confidence Interval|Least Squares Mean
171689|NCT00112437|Secondary|Percentage Change in Total Body Bone Mineral Density at 12 Months|Percentage change in total body Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set Population with Last Observation Carried Forward.||Percentage change||95% Confidence Interval|Least Squares Mean
171690|NCT00112437|Secondary|Percentage Change in Trochanter Bone Mineral Density at 12 Months|Percentage change in Trochanter Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 Months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.||Percentage change||95% Confidence Interval|Least Squares Mean
171691|NCT00112437|Secondary|Percentage Change in Femoral Neck Bone Mineral Density at 12 Months|Percentage change in femoral neck Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.||Percentage change||95% Confidence Interval|Least Squares Mean
171692|NCT00112437|Secondary|Percentage Change in Total Hip Bone Mineral Density at 12 Months|Percentage change in total hip Bone Mineral Density (relative to baseline) at 12 Months|Baseline and 12 months|This analysis was performed at Month 12 using Full-Analysis-Set approach with Last Observation Carried Forward.||Percent Change||95% Confidence Interval|Least Squares Mean
171693|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 24 Months|Percentage change in lumbar spine Bone Mineral Density (relative to baseline) at 24 Months.|Baseline and 24 months|Analysis on Lumbar Spine Bone Mineral Density (g/cm2) at Month 24 used the Full-Analysis-Set Population with Last Observation Carried Forward from Month 18 to 24. No data were carried forward from the core to the extension period. Only patients who took at least one dose of extension medication were included. 17 patients were excluded from FAS.||Percent Change||95% Confidence Interval|Least Squares Mean
171694|NCT00112437|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density at 12 Months|Percentage change in lumbar spine Bone Mineral Density (relative to baseline) at 12 Months.|Baseline and 12 months|Analysis at Month 12 used Full-Analysis-Set Population of patients who took at least one dose of study medication and had necessary follow-up information, in their randomization treatment group, with last observation data carried forward. Seven patients had a baseline value, but no value at Month 12 for lumbar spine Bone Mineral Density.||Percent Change||95% Confidence Interval|Least Squares Mean
171695|NCT00112385|Secondary|Average Daily Dose of Prednisone From Baseline to Week 52|The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.|Baseline through Week 52|||mg||Standard Deviation|Mean
171696|NCT00112385|Primary|Average Cumulative Dosage of Prednisone Over the One Year Study Period|The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.|Baseline until week 52|||mg||Standard Deviation|Mean
171697|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52."|Screening visit, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171698|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52."|At Screening, Week 12, 24, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171719|NCT00112385|Primary|Average Change in Oral Temperature From Baseline to Week 52|"The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week 0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||degrees Celsius||Standard Deviation|Mean
171699|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit."|Screening visit and Week 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171700|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171701|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171702|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171703|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171704|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171758|NCT00112294|Secondary|Median Number of Months of Survival|The median number of months of survival was defined as the time from randomization to the date of death. For participants who did not die, the date of last contact was used.|From randomization to death or date of last contact (up to 41 months).|All randomized participants (intention to treat population).||Months||95% Confidence Interval|Median
172718|NCT00105157|Secondary|Number of Patients That Died by 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
171705|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171706|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171707|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171708|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171709|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171710|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171774|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
173547|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 3|Laboratory hematology red blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
171711|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171712|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline.~Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171713|NCT00112385|Primary|Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52|"The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not.~A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52."|At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52|"Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error."||participants|||Number
171714|NCT00112385|Primary|Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.|"The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Kilograms||Standard Deviation|Mean
171715|NCT00112385|Primary|Average Change in Pulse Comparing Baseline to Week 52|"The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||beats per minute||Standard Deviation|Mean
171716|NCT00112385|Primary|Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.|"The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||mmHg||Standard Deviation|Mean
171717|NCT00112385|Primary|Average Change in Systolic Blood Pressure From Baseline to Week 52|"The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||mmHg||Standard Deviation|Mean
171718|NCT00112385|Primary|Average Change in Respiration Rate From Baseline to Week 52|"The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)).~This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40."|At Baseline (Week0) and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||breaths per minute||Standard Deviation|Mean
171720|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52|"Average change in percent predicted Diffusion Capacity (DLCO)from the Screening Visit to Week 52 was calculate. The average change was determined by subtracting the Screening test results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed during the Week 24 visit."|Screening visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Percent predicted||Standard Deviation|Mean
171721|NCT00112385|Other Pre-specified|Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52|"The average change in percent predicted Forced Expiratory Volume in 1 second (FEV1) from Screening to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed during the Week 24 visit."|Screening Visit and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Percent predicted||Standard Deviation|Mean
171722|NCT00112385|Other Pre-specified|Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52.|"The average change in percent predicted Forced Vital Capacity (FVC) from the Screening Visit to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.~This assessment was also completed at the Week 24 visit."|Screening Visit and Week 52.|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Percent predicted||Standard Deviation|Mean
171723|NCT00112385|Other Pre-specified|Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52|"The Health Assessment Questionnaire (HAQ)was completed by subjects to assess the affects of their illness on the ability to function in daily life. The HAQ consists of 8 sections. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).The 8 scores of the 8 sections are summed and divided by 8. A higher score indicates more impairment.~The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Units on a scale||Standard Deviation|Mean
171724|NCT00112385|Other Pre-specified|Change in Pruritis Rating From Baseline to Week 52|"This is the average change in pruritis score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived level of pruritis (itchiness). A score of 0 cm indicated Not itchy at all. A score of 10.0 cm indicated Extremely itchy.~This assessment was also completed at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0), and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||cm||Standard Deviation|Mean
171725|NCT00112385|Other Pre-specified|Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline|"Average change in Cutaneous Disease Activity and Severity Index (CDASI) score from Baseline to Week 52. The assessment graded the severity of the subject's rash. The rash was rated using a a 4-point scale with a score of 0 indicating no rash. The score was added together using all 13 anatomical locations included on the assessment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Units on a scale||Standard Deviation|Mean
171726|NCT00112385|Other Pre-specified|Average Change in Patient Global Activity Assessment Score From Baseline to Week 52|"Average change in Patient Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease.~This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||cm||Standard Deviation|Mean
171727|NCT00112385|Other Pre-specified|Average Change in Physician Global Activity Assessment From Baseline to Week 52|"Average change in Physician Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||cm||Standard Deviation|Mean
171775|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171728|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52|The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the lumbar spine was calculated comparing the results from the Screening visit to Week 52. The average change was determined by subtracting the Screening Visit (Week <8)test results from the Week 52 results (Week 52- screening Visit). The Screening visit occurred within 8 weeks of the Baseline visit.|Screening visit and Week 52.|Data for all subjects enrolled in the trial are not available for this assessment. One subject left the study early and one subject was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.||Z-Score||Standard Deviation|Mean
171729|NCT00112385|Other Pre-specified|Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52|"The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the femur from the Screening visit to the Week 52 visit was calculated. The average change was determined by subtracting the Screening Visit test results from the Week 52 results (Week 52- Screening visit).~The Screening visit was conducted within 8 weeks of the Baseline visit."|Screening and Week 52|"Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error."||Z-score||Standard Deviation|Mean
171730|NCT00112385|Other Pre-specified|Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52|"Average change in time to walk 30 feet comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Seconds||Standard Deviation|Mean
171731|NCT00112385|Other Pre-specified|Average Change in Time to Rise From a Chair From Baseline to Week 52|"The Average change in time to rise from a chair comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).~This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40."|At Baseline (Week0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Seconds||Standard Deviation|Mean
171732|NCT00112385|Primary|Tolerability|The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.|At any point between Baseline (week 0) and the end of the study (Week 52)|||Participants|||Number
171733|NCT00112385|Other Pre-specified|Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52|"The Manual Muscle Test (MMT) assesses 26 muscle groups. The muscle strength of each muscle group is graded. The score for each muscle group ranges from 0 (No contraction palpable) to 5 (normal strength). The minimum total MMT score is a 0. The maximum total MMT score is a 130.~The average change in the average Manual Muscle Testing (MMT)from Baseline to Week 52 was calculated. The average score is composed of 26 muscle groups that were tested. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline)."|At Baseline (Week 0) and Week 52|Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.||Units on a scale||Standard Deviation|Mean
171734|NCT00112385|Secondary|Average Prednisone Dosage After Week 24|We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52).|from week 24 to 52|||mg||Inter-Quartile Range|Median
171735|NCT00112385|Other Pre-specified|The Number of Participants Who Were Classified as Treatment Failures|Treatment failures were determined based on criteria from the study protocol using objective and subjective ratings from the study physician. If the study physician felt that the rate of prednisone taper needed to be reduced, the prednisone dose needed to be increased or restarted, or a second-line agent added, the patient will be considered to be a treatment failure.|At any point during the 52 week study|||participants|||Number
171736|NCT00112385|Primary|Occurrence of at Least One Adverse Event|"Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of mild, moderate or severe matches with the descriptions from the CTCAE dictionary.~In general, a Mild AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated.~A Moderate AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living.~A Severe AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling;"|at each visit during the 12 month study|Intention- to -Treat (ITT)||participants|||Number
171737|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||μg/mL|Participants||Number
171738|NCT00112359|Secondary|Number of Participants Hospitalized at Least Once Between Day 0 and Day 42|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||participants|||Number
171739|NCT00112359|Primary|Change in CFQ-R Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R respiratory symptoms scale (RSS; range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||units on a scale||Standard Error|Least Squares Mean
171740|NCT00112359|Secondary|Number of Participants Receiving Intravenous (IV) or Inhaled Antipseudomonal Antibiotics Other Than Trial Drug|Use of IV and inhaled antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF.|Day 0 to Day 42|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received.||participants|||Number
171741|NCT00112359|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of 1 dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
171742|NCT00112359|Secondary|Percent Change in FEV1 (L)|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. The percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was determined at Day 28.|Day 0 to Day 28|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
171743|NCT00112359|Other Pre-specified|Minimum Inhibitory Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"PA isolates from sputum samples (collected at all visits) were assessed for their susceptibility to aztreonam.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||μg/mL|Participants||Number
171744|NCT00112359|Other Pre-specified|Number of Participants With Other Pathogens Present|Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.||participants|||Number
171745|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 42|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||units on a scale||Standard Error|Least Squares Mean
171746|NCT00112359|Secondary|Change in CFQ-R RSS Score|The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 14|ITT population: participants randomized to treatment who received at least part of 1 dose of study drug. Participants summarized by actual treatment received. Missing baseline data not imputed. Missing post-baseline data imputed using worst-case value for withdrawals due to AE or study drug intolerance. All other missing data: LOCF method used.||units on a scale||Standard Error|Least Squares Mean
171747|NCT00112294|Secondary|Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures|Participants were to complete log to collect information on unscheduled visits to physicians,clinics,hospitals & other unscheduled major procedures.If asked, participants were to complete and return log to site upon routinely scheduled visits.The purpose of this exploratory analysis was to understand the economical implications as a secondary objective.This was not a pivotal study & therefore not needed to support any arguments with regulatory authorities concerning cost-benefit,hence,it was not necessary to conduct this analysis. There is no intent on conducting this analysis in the future.|Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).|This analysis was not performed.|||||
171748|NCT00112294|Secondary|Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the NCI CTC, version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Hyperglycemia (non-fasting): Grade 3, serum glucose >13.9 – 27.8 mmol/L; Grade 4 >27.8 mmol/L or acidosis. Hypomagnesemia: Grade 3, serum magnesium >1.23 – 3.30 mmol/L; Grade 4 >3.30 mmol/L. Hyponatremia: Grade 3, serum sodium <130 – 120 mmol/L; Grade 4 <120 mmol/L. Low albumin: Grade 3, serum albumin <20 g/L; Grade 4 not applicable.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
171749|NCT00112294|Other Pre-specified|Median Change From Baseline in Symptoms, by Time Point|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). The median change from baseline score was calculated at 3-weekly intervals. See also Outcome Measure 8.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization). n = number of participants with a score at both the baseline and at the specified time point (each arm respectively).||Units on a scale||Inter-Quartile Range|Median
171750|NCT00112294|Secondary|Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants|Abnormalities were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The scale is graded from 1 (least severe) to 4 (life threatening). Grade 3 and 4 criteria are defined as follows: Neutropenia: Grade 3, neutrophils <1.0 - 0.5 x 10^9/L; Grade 4, <0.5 x 10^9/L. Leukopenia: Grade 3, leukocytes <2.0 – 1.0 x 10^9/L; Grade 4, <1.0 x 10^9/L. Thrombocytopenia: Grade 3, platelets <50.0 – 25.0 x 10^9/L; Grade 4, <25.0 x 10^9/L. Anemia: Grade 3, hemoglobin <4.9 – 4.0 millimoles (mmol)/L, Grade 4, <4.0 mmol/L.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
171751|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Cardiac AEs|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term “cardiac AE” were of particular importance. These AEs, coded as preferred or other level Medical Dictionary for Regulatory Activities [MedDRA] terms were: coronary artery disorders, cardiac arrhythmias, heart failures not elsewhere classified, left ventricular failures, sudden cardiac death, cardiac death and sudden death.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
171752|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Infusion Reaction|"AE=any new untoward medical occurrence or worsening of pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term infusion reaction were of particular importance. These AEs were: infusion-related reaction, hypersensitivity, anaphylactic reaction, anaphylactic shock, and anaphylactoid reaction regardless of when they occurred. The terms dyspnea, pyrexia and chills were also grouped under infusion reaction, provided the onset date of these toxicities occurred on the first day of study treatment."|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
171753|NCT00112294|Secondary|Number of Participants Experiencing Other Significant AEs: Acneform Rash|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs that were categorized under the composite term “acneform rash” were of particular importance. These AEs were: rash, rash pustular, rash erythematous, dermatitis acneiform, dermatitis exfoliative, rash papular, rash pruritic, rash generalised, rash macular, rash maculo-papular, acne, acne pustular, skin desquamation and dry skin.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||Participants|||Number
171754|NCT00112294|Secondary|Number of Participants Experiencing AEs Leading to Study Drug Discontinuation|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). The results presented are stratified according to which drug was discontinued.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants.||participants|||Number
171755|NCT00112294|Secondary|Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). An SAE was defined as an AE that resulted in death, was life-threatening, required hospitalization (or prolongation of existing hospitalization), or was an important medical event.|From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).|All treated participants. The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.||Participants|||Number
171756|NCT00112294|Secondary|Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)|Symptoms were assessed using the FACT-LCS questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic) to 28 (symptom-free). Symptomatic progression was defined as >= 2-point decrease from baseline in score (maintained for 2 consecutive assessments at least 3 weeks apart). Time to symptomatic progression was defined as the time from randomization to date of symptoms worsening. For participants with no symptom progression, the date of the last symptom assessment was used. See also Outcome Measure 15.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed baseline FACT-LCS questionnaire (ie, completed questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score greater than or equal to 2. As the median was not reached, no data are presented here (see Outcome Measure 15).|||||
171757|NCT00112294|Secondary|Number of Participants With Improvement of Symptoms|Symptoms were assessed using the Functional Assessment of Cancer Therapy – Lung Cancer Subscale (FACT-LCS) questionnaire. This 7-item scale has scores ranging from 0 (severely symptomatic in all symptoms assessed) to 28 (symptom-free on all symptoms assessed). Symptom response (improvement) was defined as >= 2-point increase from baseline in score (maintained for 2 consecutive assessments, at least 3 weeks apart). Participants with a baseline score of >= 27 were not evaluable, as it would not have been possible to show an improvement. Participants with no baseline data were also not evaluable.|From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).|All randomized participants who completed a baseline FACT-LCS questionnaire (ie, who completed a questionnaire <=14 days prior to treatment, or if they were never treated, <=14 days prior to randomization) and who had a baseline score of 26 or less.||Participants|||Number
172594|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 24, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
171759|NCT00112294|Secondary|Median Number of Months to Response|The median number of months to response was calculated for participants whose best response was CR or PR. It was defined as the time from the first dose of study therapy to the first date that criteria for PR or CR (whichever occurred first)were met. Response was assessed by the IRRC, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).|All randomized participants with a best response of CR or PR.||Months||Full Range|Median
171760|NCT00112294|Secondary|Median Number of Months of Response|Median number of months of response (time from first occurrence of CR/PR to date of PD/death, [per IRRC assessment,using modified WHO criteria]) calculated for participants whose best response=CR/PR.For participants who did not progress/die, date of last tumor assessment used.CR:disappearance of all index/non-index lesions;PR:>= 50% reduction in SOPD of index lesions compared with baseline, no evidence of progression.No new lesions present.PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion.|Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).|All randomized participants with a best response of CR or PR.||Months||95% Confidence Interval|Median
171761|NCT00112294|Secondary|Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)|Disease control was defined as the number of participants whose best response was CR, PR, or SD, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR:>= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression (to qualify as CR or PR, no new lesions could be present); SD: participants who did not meet the criteria for CR, PR, or PD (PD:>=25% increase in SOPD of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion).|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).||Participants|||Number
171762|NCT00112294|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|Tumor response was defined as the number of participants whose best response was CR or PR, per the IRRC assessment, using the modified WHO criteria: CR: disappearance of all index/non-index lesions; PR: >= 50% reduction in the SOPD of index lesions compared with the baseline SOPD, with no evidence of progression. To qualify as CR or PR, no new lesions could be present.|From randomization to end of study drug therapy (up to 174 weeks).|All randomized participants (intention to treat population).||Participants|||Number
171763|NCT00112294|Primary|Median Number of Months of Progression-free Survival (PFS)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).|All randomized participants (intention to treat population).||Months||95% Confidence Interval|Median
171764|NCT00112151|Secondary|Fat Free Mass (kg)|Total change in Fat free mass (kg) as evaluated by DXA|Baseline and 12 months|||kg||Standard Deviation|Mean
171765|NCT00112151|Secondary|Fat Mass (kg)|Total change in Fat mass (kg) as evaluated by DXA|Baseline and 12 months|||kg||Standard Deviation|Mean
171766|NCT00112151|Secondary|Power (Power Rig, Watts)|Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).|Baseline and 12 months|||Watts||Standard Deviation|Mean
171767|NCT00112151|Secondary|Lower Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.|Baseline and 12 months|||kg||Standard Deviation|Mean
171768|NCT00112151|Secondary|Upper Body Muscle Strength (1-RM, kg)|The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.|Baseline and 12 months|||kg||Standard Deviation|Mean
171769|NCT00112151|Primary|Physical Function (CS-PFP Total Score)|Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.|Baseline and 12 months|||units on a scale||Standard Deviation|Mean
171770|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171771|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 14-28|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171772|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171773|NCT00112112|Secondary|Influenza B IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 3-5|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
175893|NCT00069823|Secondary|Pulmonary Function: Change in Peak Flow Rate|Mean change from baseline to 24 weeks in the peak flow rate - how forceful patient can blow out air|Baseline to 24 Weeks|||liters/min||95% Confidence Interval|Mean
171778|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 3-5|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171779|NCT00112112|Secondary|Influenza A/H3N2 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171780|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171781|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 14-28|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171782|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171783|NCT00112112|Secondary|Influenza A/H1N1 IgA|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|Day 3-5|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171784|NCT00112112|Secondary|Influenza A/H1N1 Immunoglobulin A (IgA)|Mean of influenza-specific IgA from nasal swab. Titers of < 1 were assigned the value of 0.5.|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||titer||Standard Deviation|Mean
171785|NCT00112112|Secondary|Number of Participants Who Experienced a ≥ 4-fold Rise in Influenza B Microneutralization Titers|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers ≥ 4 from baseline|Baseline to Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||participants|||Number
171786|NCT00112112|Secondary|Number of Participants Who Experienced a ≥ 4-fold Rise in Influenza A/H3N2 Microneutralization Titers|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers ≥ 4 from baseline|Baseline to Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||participants|||Number
171787|NCT00112112|Secondary|Number of Participants Who Experienced a ≥ 4-fold Rise in Influenza A/H1N1 Microneutralization Titers|Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers ≥ 4 from baseline|Baseline to Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||participants|||Number
171788|NCT00112112|Secondary|Number of Participants Who Experienced a ≥ 4-fold Rise in Serum Influenza B HAI Titers|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers ≥ 4 from baseline|Baseline to Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||participants|||Number
171789|NCT00112112|Secondary|Number of Participants Who Experienced a ≥ 4-fold Rise in Serum Influenza A/H3N2 HAI Titers|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers ≥ 4 from baseline|Baseline to Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||participants|||Number
171790|NCT00112112|Secondary|Number of Participants Who Experienced a ≥ 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers|Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers ≥ 4 from baseline|Baseline to Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no significant protocol deviations.||participants|||Number
171791|NCT00112112|Secondary|HLA Matched Tetramers CD8+||Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||% of lymphocytes||Standard Deviation|Mean
171792|NCT00112112|Secondary|HLA Matched Tetramers CD8+||Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||% of lymphocytes||Standard Deviation|Mean
171793|NCT00112112|Secondary|Human Leukocyte Antigen (HLA) Matched Tetramers CD8+||pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||% of lymphocytes||Standard Deviation|Mean
171794|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells|Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||cells per 10^5 T cells||Standard Deviation|Mean
171795|NCT00112112|Secondary|IL-4|Mean and standard deviation spots-forming cells per 10^5 T cells|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||cells per 10^5 T cells||Standard Deviation|Mean
173548|NCT00095498|Secondary|Change From Baseline in Red Blood Cells at Month 1|Laboratory hematology red blood cells|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
171796|NCT00112112|Secondary|Interleukin (IL)-4|Mean and standard deviation spots-forming cells per 10^5 T cells|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||cells per 10^5 T cells||Standard Deviation|Mean
171797|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells|Day 35-42|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||cells per 10^5 T cells||Standard Deviation|Mean
171798|NCT00112112|Secondary|INF-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||cells per 10^5 T cells||Standard Deviation|Mean
171799|NCT00112112|Secondary|Interferon (INF)-Gamma|Mean and standard deviation spots-forming cells per 10^5 T cells|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations. Participants must have had a pre-dose and any post-dose measurement.||cells per 10^5 T cells||Standard Deviation|Mean
171800|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171801|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171802|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171803|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|Day 7-10|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171804|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD8|Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171805|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD4|Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171806|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD3|Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171807|NCT00112112|Secondary|T- and B-lymphocyte Subsets by Flow Cytometry - CD19|Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.|pre-dosing (Day 0)|All participants randomized who received a full dose of study vaccine, had any valid results in the evaluation of immune response, and had no protocol deviations.||percent of lymphocytes||Standard Deviation|Mean
171808|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus.|Unscheduled visits occurring during days 0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs during unscheduled illness visits.||participants|Participants||Number
171809|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.|35-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
171810|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus.|14-28 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
171811|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus.|7-10 days after study vaccination|||participants|||Number
171812|NCT00112112|Secondary|Number of Participants Shedding Vaccine-like Virus|Number of participants with nasal swab samples that contained vaccine-like virus.|3-5 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
171813|NCT00112112|Primary|Number of Significant New Medical Conditions (SNMCs)|A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.|43-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs. Subjects were analyzed based on study drug actually received.||events|||Number
171861|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48|Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 48|As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||Log10 c/mL||Standard Deviation|Mean
171814|NCT00112112|Primary|Number of Participants Who Had Adverse Events (AEs)|An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
171815|NCT00112112|Primary|Number of Serious Adverse Events (SAEs)|An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.|0-180 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||events|||Number
171816|NCT00112112|Primary|Number of Participants Who Had Reactogenicity Events (REs)|Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. For the participants enrolled in this study REs include fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.|0-42 days after study vaccination|Participants who received any study vaccine and had any follow-up for REs and/or AEs.||participants|||Number
171817|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Composite Score||Standard Deviation|Mean
171818|NCT00112047|Secondary|Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population).|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Composite Score||Standard Deviation|Mean
171819|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
171820|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
171821|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
171822|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
171862|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set||Percentage of participants|||Number
176255|NCT00062738|Primary|Hamilton Depression Scale|total score on HDRS (0-54 higher score is worse)|8 weeks|intent to treat - total patients in the arm||units on a scale||Standard Deviation|Least Squares Mean
171823|NCT00112047|Secondary|Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.|"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)."|Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)|Atripla Efficacy Analysis Set||Participants|||Number
171824|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||total body fat (kg)||Standard Deviation|Mean
171825|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||trunk fat (kg)||Standard Deviation|Mean
171826|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||limb fat (kg)||Standard Deviation|Mean
171827|NCT00112047|Secondary|Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)|Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value|Study/Atripla baseline to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||CD4 Cell count (Cells/mm^3)||Standard Deviation|Mean
171828|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"||Percentage of Participants|||Number
171829|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 240 (Atripla Week 96)|"MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).~Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)"||Percentage of Participants|||Number
171830|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
171831|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
171832|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
171833|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
171834|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set||Percentage of Participants|||Number
171863|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Baseline to 48 Weeks|ITT analysis set||Percentage of Participants|||Number
171835|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit.|Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)|Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set.||Percentage of Participants|||Number
171836|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)||total body fat (kg)||Standard Deviation|Mean
171837|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)||trunk fat (kg)||Standard Deviation|Mean
171838|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 144|Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value|Week 48 to Week 144|ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)||limb fat (kg)||Standard Deviation|Mean
171839|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144|Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 144|AT analysis set||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
171840|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144|Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 144|AT analysis set||Log10 c/mL||Standard Deviation|Mean
171841|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT||Percentage of Participants|||Number
171842|NCT00112047|Secondary|Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 144|MITT||Percentage of participants|||Number
171843|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144|MITT||Percentage of Participants|||Number
171844|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 144|MITT||Percentage of Participants|||Number
171845|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set (Missing Observation or Switch in ART=Failure)||Percentage of Participants|||Number
171846|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|Week 144|ITT Analysis set||Percentage of Participants|||Number
171847|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit.|Week 144|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 458).||Percentage of participants|||Number
171864|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Baseline to 48 Weeks|ITT analysis set||Percentage of Participants|||Number
171848|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit.|144 weeks|Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 456).||Percentage of Participants|||Number
171849|NCT00112047|Secondary|Change in Total Body Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value|48 weeks to 96 weeks|ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93)||total body fat (kg)||Standard Deviation|Mean
171850|NCT00112047|Secondary|Change in Trunk Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value|Week 48 to Week 96|ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)||trunk fat (kg)||Standard Deviation|Mean
171851|NCT00112047|Secondary|Change in Limb Fat (kg) From Week 48 to Week 96|Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value.|Week 48 to Week 96|ITT (whole body dual-energy X-ray absorptiometry [DEXA] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)||limb fat (kg)||Standard Deviation|Mean
171852|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96|Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value|Baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
171853|NCT00112047|Secondary|Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96|Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).|Study baseline to Week 96|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||Log10 c/mL||Standard Deviation|Mean
171854|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT||Percentage of Participants|||Number
171855|NCT00112047|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96|Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.|Week 96|MITT||Percentage of Participants|||Number
171856|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Week 96|MITT||Percentage of Participants|||Number
171857|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96|TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1.|Week 96|MITT||Percentage of Participants|||Number
171858|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit.|Week 96|Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [465])||Percentage of Participants|||Number
171859|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit.|96 Weeks|Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [463])||Percentage of Participants|||Number
171860|NCT00112047|Secondary|Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48|Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value|Study baseline to Week 48|AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.||CD4 Cell Count (cells/mm^3)||Standard Deviation|Mean
171865|NCT00112047|Secondary|Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48|TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.|Baseline to 48 weeks|ITT analysis set||Percentage of Participants|||Number
171866|NCT00112047|Secondary|Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).|48 Weeks|ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).||Percentage of Participants|||Number
171867|NCT00112047|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.|The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).|48 weeks|Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).||Percentage of Participants|||Number
171868|NCT00112047|Secondary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)|Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit.|Week 48|MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])||Percentage of Participants|||Number
171869|NCT00112047|Primary|Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm|Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit.|48 weeks|Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])||Percentage of participants|||Number
171870|NCT00111917|Post-Hoc|BAL % Lymphocytes|% of WBCs that are lymphocytes in bronchoalveolar lavage|after 28 week infusion|||percentage of lymphocytes in BAL||Standard Deviation|Median
171871|NCT00111917|Post-Hoc|BAL WBC/cc|WBC * 10^6/cc in bronchalveolar lavage|after 28 weeks|||absolute WBC*10^6/cc||Standard Deviation|Median
171872|NCT00111917|Primary|A-a Gradient at End Exercise|change in end-exercise A-a gradient|after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen|Accurate measures were not obtained on all patients at both timepoints.||mmHg||Standard Error|Median
171873|NCT00111917|Post-Hoc|Absolute Numbers of Lymphocytes|Absolute number of lymphocytes*10^6/cc in blood|after 28 week follow-up|||absolute number*10^6/cc||Standard Error|Median
171874|NCT00111813|Secondary|Laboratory AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.~A lab (S)AE was any lab value considered clinically significant in the investigator's judgment."|Day 1 up to disease progression, toxicity, or death, assessed up to 29 months|||Participants|||Number
171875|NCT00111813|Secondary|Clinical AE Summary|"An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.~A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose."|Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)|||Participants|||Number
171876|NCT00111813|Secondary|Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months|||Days||Standard Deviation|Mean
172033|NCT00109850|Secondary|Progression Free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 5 years|All eligible patients who started treatment were included in the analysis.||months||95% Confidence Interval|Median
171877|NCT00111813|Secondary|Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug|An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.|Day 1 to disease progression, toxicity, or death, assessed up to 29 months|||Participants|||Number
171878|NCT00111813|Primary|Mean Duration of Treatment With Vorinostat|"Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity.~Progressive disease was defined as:~>25% increase in the level of serum monoclonal paraprotein.~25% increase in 24-hour urinary light chain excretion.~>25% increase in plasma cells in a bone marrow aspirate or on trephine~biopsy.~Development of new bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia.~Intolerable toxicity was based on the clinical judgment of the investigator."|Day 1 to an event causing discontinuation from the study, assessed up to 29 months|||Days||Full Range|Mean
171879|NCT00111761|Secondary|Time to Initial Objective Tumor Response (Part 1)|Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subset of Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy, who had an objective tumor response.||weeks||Inter-Quartile Range|Median
171880|NCT00111761|Secondary|Time to Treatment Failure (Part 1)|Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||Weeks||95% Confidence Interval|Median
171881|NCT00111761|Secondary|Survival Time (Part 1)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
171882|NCT00111761|Secondary|Time to Disease Progression (Part 1)|Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
171883|NCT00111761|Secondary|Progression-free Survival Time (Part 1)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 25 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
171884|NCT00111761|Secondary|Number of Participants With Objective Tumor Response (Part 1)|Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||Participants|||Number
171885|NCT00111761|Secondary|Number of Participants Who Died (Part 2)|The number of participants in Part 2 who died during the study.|From enrollment until last contact. Maximum follow-up was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||participants|||Number
171886|NCT00111761|Secondary|Survival Time (Part 2)|Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.|From enrollment until death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||weeks||95% Confidence Interval|Median
171887|NCT00111761|Secondary|Progression-free Survival Time (Part 2)|Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.|From enrollment until disease progression or death. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||weeks||95% Confidence Interval|Median
171888|NCT00111761|Secondary|Time to Disease Progression (Part 2)|Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.|From enrollment until death or diease progression. Maximum follow-up time was 16 months.|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||weeks||95% Confidence Interval|Median
171889|NCT00111761|Secondary|Number of Participants With an Objective Tumor Response (Part 2)|Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy||Participants|||Number
171890|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)|The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first|Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.||Participants|||Number
171891|NCT00111761|Primary|Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)|The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).|Until disease progression (median 47 weeks)|Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy.||Participants|||Number
171892|NCT00111657|Secondary|Infusion 1: Minimum Concentration (Cmin)|The lowest drug concentration in the blood after the first infusion of study drug.|21 days after the infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.||mU/mL||Standard Deviation|Mean
171893|NCT00111657|Secondary|Infusion 1: Maximum Concentration (Cmax) Value|The highest drug concentration in the blood after the first infusion of study drug.|2 hours|One subject withdrew prior to completing the first infusion and is not included in this analysis.||mU/mL||Standard Deviation|Mean
171894|NCT00111657|Secondary|Development of Antibodies to PEG-uricase|Number of patients who developed antibodies to PEG-uricase|baseline, then prior to infusions and 7 wks after last infusion|One subject withdrew prior to completing the first infusion and is not included in this analysis.||participants|||Number
171895|NCT00111657|Secondary|Reduction of the Ratio of Uric Acid:Creatinine in Urine||baseline then weekly|These data were not calculated because the effect size of serum irate reduction in plasma was so robust that there was no utility in this assessment.|||||
171896|NCT00111657|Secondary|In a Subset of Subjects Who Volunteer Separately, Change in Uric Acid Pool Size Will be Assessed by a Method That Involves Infusion of Uric Acid Labeled With N15, a Stable (Nonradioactive) Isotope of Nitrogen.||baseline and 7 weeks after last infusion|Data was not collected for this outcome as a result of a separate pilot study demonstrating that the measure was not useful.|||||
171897|NCT00111657|Secondary|Clinical Response: Number of Swollen and Tender Joints|Count of tenderness and swelling of 68 joints|Basline and day 134|30 subject assesed at baseline. 21 subjects who completed study were assesed at day 134||joints||Inter-Quartile Range|Median
171898|NCT00111657|Primary|Reduction in Plasma Uric Acid to Less Than 6 mg/dL.||Baseline to Day 105|||Participants|||Number
171899|NCT00111007|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)|Change in ECOG PS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||participants|||Number
171900|NCT00111007|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 197 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||Full Range|Median
171901|NCT00111007|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 126 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||95% Confidence Interval|Median
171902|NCT00111007|Secondary|Overall Survival (OS)|Overall survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (median time of 294 days)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||95% Confidence Interval|Median
171911|NCT00110994|Secondary|Number of Participants in Tumor Response Categories|Tumor response was defined as the best response (confirmed complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST). PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD. CR: Disappearance of all target lesions. SD: Does not qualify for CR or PR. PD: at least a 20% increase in SLD taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions.|Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Tumor response was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||participants|||Number
171903|NCT00111007|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (median time of 124 days)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.||days||95% Confidence Interval|Median
171904|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents’ self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
171905|NCT00110994|Secondary|Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
171906|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
171907|NCT00110994|Secondary|Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted|European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ‑5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health.|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||scores on a scale||Standard Deviation|Mean
171908|NCT00110994|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted|Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started).|Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days|Change in ECOG performance status was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||participants|||Number
171909|NCT00110994|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment.|Time from initial response to documented tumor progression or death (median time of 188 days)|DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
171910|NCT00110994|Secondary|Time to Progression (TTP)|TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day.|Time from randomization to documented tumor progression (median time of 148 days)|TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
171912|NCT00110994|Secondary|Overall Survival (OS)|Overall Survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date.|Time from randomization to death (the maximum treatment duration of 71.1 weeks)|OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
171913|NCT00110994|Primary|Progression Free Survival (PFS)|PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day.|Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)|PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.||days||95% Confidence Interval|Median
171914|NCT00110890|Secondary|Number of Participants With Mean Serum P < 5.5 mg/dL|Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
171915|NCT00110890|Secondary|Number of Participants With Mean Serum Ca < 9.5 mg/dL|Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
171916|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
171917|NCT00110890|Secondary|Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL|Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assesment Phase (weeks 17-23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
171918|NCT00110890|Primary|Number of Participants With Mean PTH ≤ 300 pg/mL|Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase|Efficacy Assessment Phase (weeks 17 to 23)|Full Analysis Set, composed of all randomized participants with imputation using modified last value carried forward (mLVCF)||Participants|||Number
171919|NCT00110812|Post-Hoc|Commencement of Continuous Antiretroviral Treatment|Number of patients commencing continuous antiretroviral treatment.|from randomization through February 28, 2011, the end of the extension phase|All randomized patients are counted. Patients who did not consent to the extension phase are censored at the end of the main study (Feb 28, 2009). Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||participants|||Number
171920|NCT00110812|Post-Hoc|Undetectable HIV-RNA|Patients with undetectable HIV-RNA levels measured at 24 months after the close of the main study, at the end of the extension phase.|24 months post-trial|All patients for whom an HIV-RNA measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||participants|||Number
171921|NCT00110812|Post-Hoc|CD4+ Cell Count 2 Years Post-study||two years following close of main study|All patients for whom a CD4 count measurement was available during the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||cell/mm^3||Standard Deviation|Mean
171922|NCT00110812|Post-Hoc|Opportunistic Disease or Death During the Trial Extension Phase|Incidence of an opportunistic event (AIDS-defining infection or malignancy) or death between February 28, 2009, when the main study ended, and February 28, 2011, when the extended phase was completed.|two years following close of main study|All patients who were alive at the end of the main study and who consented to be followed for an additional 2 years in the extension phase. Because the focus of the extension was on the safety of patients exposed to IL-2, the outcomes were summarized for the two groups exposed to IL-2 vs. the group that did not take IL-2.||participants|||Number
171923|NCT00110812|Secondary|SGOT|Number of participants with aspartate aminotransferase (SGOT) greater than 5 times the upper limit of normal|week 32|all patients with SGOT measured at week 32||participants|||Number
171924|NCT00110812|Secondary|Thyroid Stimulating Hormone|Number of participants with thyroid stimulating hormone greater than the upper limit of normal|week 32|all patients with TSH measured at 32 weeks||participants|||Number
171925|NCT00110812|Secondary|Change in HIV-RNA Copies/ml (log10) From Baseline to Month 12||month 12|patients for whom HIV-RNA measurement was available at baseline and month 12.||copies/ml (log 10)||Standard Deviation|Mean
171926|NCT00110812|Secondary|Initiation of Continuous ART|While patients were not taking ART at baseline or while undergoing IL-2 cycles (other than use of pericycle ART in one of the three groups), some chose to start an ART regimen during the study.|from randomization through February 28, 2009|all patients randomized||participants|||Number
171927|NCT00110812|Secondary|Disease Progression or Death|occurrence of an opportunistic event (AIDS-defining infection or malignancy) or death|throughout study, through Feb 28 2009 (median followup of 19 months)|all randomized patients||participants|||Number
171928|NCT00110812|Secondary|Fasting Lipid Profile|total fasting cholesterol|week 32|all patients with laboratory data at week 32 who reported fasting||mg/dl||Standard Deviation|Mean
171929|NCT00110812|Secondary|HIV-1 Genotype Changes|Patients who developed mutations associated with antiretroviral drugs.|after 3rd cycle of IL-2|Per protocol, the analysis of genotypic changes associated with antiretroviral resistance was restricted patients in one arm, namely, patients assigned to take pericycle HAART who completed 3 cycles of IL-2 and who had successful genotypes.||participants|||Number
171930|NCT00110812|Secondary|Change in CD4 T Lymphocyte Count|change from baseline to month 12 in CD4 T lymphocyte count|At Month 12|patients for whom the month 12 CD4 count was available||cell/mm^3||Standard Deviation|Mean
171931|NCT00110812|Secondary|Plasma HIV RNA|change from baseline in HIV-RNA copies/ml (log10)|At Week 32|Patients for whom HIV-RNA was available at week 32||copies/ml (log 10)||Standard Deviation|Mean
171932|NCT00110812|Secondary|Discontinuation of IL-2|Patients receiving fewer than 3 cycles of IL-2 by week 32|week 32|all patients randomized to a study arm containing IL-2||participants|||Number
171934|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 104|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 104 for the Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 104 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had assessment of serum ferritin at Start of ICL670 treatment and at 104 weeks.||mg/mL||95% Confidence Interval|Least Squares Mean
171935|NCT00110617|Primary|The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment|The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks.|24 Weeks|Safety-1 set: All participants, except participants enrolled in Center 512, who received at least one dose of study medication during the first 24 weeks.||participants|||Number
171936|NCT00110617|Secondary|Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 24 and to Week 52|Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 24 and the absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 52 for the Deferasirox treatment group and the Deferoxamine then Deferasirox treatment group. Means were adjusted for the amount of transfused blood.|Start of Deferasirox (ICL670) treatment, 24 Weeks, 52 Weeks|Per Protocol- 2 set defined as all participants who received study drug and had an assessment of serum ferritin at Start of ICL670 treatment and at 24 weeks or 52 weeks.||mg/mL||95% Confidence Interval|Least Squares Mean
171937|NCT00110617|Secondary|Absolute Change in Serum Ferritin From Baseline to Week 24|Absolute change from baseline serum ferritin after 24 weeks of treatment with Deferasirox (ICL670) and absolute change from baseline serum ferritin after 24 weeks of treatment with Deferoxamine. Means were adjusted for the amount of transfused blood.|Baseline, 24 Weeks|Per protocol- 1 defined as all participants who had study drug and had an assessment of serum ferritin at Baseline and at Week 24.||mg/mL||95% Confidence Interval|Least Squares Mean
171938|NCT00110513|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT)|To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.|During treatment and follow up period of 7 days|Intent to treat population||Participants|||Number
171939|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171940|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171941|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous week, only randomized subjects who had both previous week and at least next week were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171942|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171976|NCT00110357|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan|MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)|Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.|As-treated population||mg/m2|||Number
171943|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 30|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171944|NCT00110461|Secondary|Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse)."|Baseline and Week 4|Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171945|NCT00110461|Secondary|Subject Response to Treatment at Week 30|"Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.||percentage of participants|||Number
171946|NCT00110461|Secondary|Subject Response to Treatment at Week 4|"Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.||percentage of participants|||Number
171947|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30|"Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171948|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171949|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4|Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171977|NCT00110357|Secondary|Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)|Toxicity assessments performed at least weekly from the 1st dose of study drug until at least 30 days after the final dose of study drug and thereafter every 4 weeks until all study-related toxicities resolved, returned to baseline, or were deemed irreversible, whichever was longer. Grade 3=severe AE; grade 4=disabling or life threatening.|Weekly throughout the study and every 4 weeks thereafter|All treated patients||Participants|||Number
176677|NCT00050622|Primary|Classroom Behavior|Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.|Daily for 45 days|||Percentage of Work Completed||Standard Deviation|Mean
171950|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30|Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171951|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171952|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171953|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171954|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30|Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171955|NCT00110461|Secondary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30|Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171956|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171979|NCT00110357|Secondary|Tumor Response|"Non-central nervous system (CNS) tumors evaluated using Response Evaluation Criteria In Solid Tumors (RECIST), criteria to define when cancer patients improve (respond), stay the same (stable), or worsen (progression). CNS tumors evaluated based on measurements by investigator, dependence on corticosteroids, and neurologic exam."|Every other 21-day cycle|All treated subjects||Participants|||Number
171957|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171958|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30|"Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171959|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4|"Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171960|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30|"Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171961|NCT00110461|Secondary|Change in Children's Global Assessment (CGAS) Total Score at Week 30|"Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 30|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171962|NCT00110461|Secondary|Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4|Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171963|NCT00110461|Secondary|Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4|Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171978|NCT00110357|Secondary|Human Anti-cetuximab Antibody (HACA) Response|In order to be considered positive for anti-cetuximab a sample had to: 1) be evaluable (i.e., have a pre and at least one post-treatment timepoint), 2) have an anti-cetuximab value > 7 ng/mL and 3) have a post-treatment sample at least twice the pre-treatment level.|Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle|Cohort comprises all enrolled participants who were tested for HACA. Evaluable participants had normal baseline HACA (≤ 7 ng/dL) and ≥1 postbaseline HACA levels; unevaluable participants either did not have enough sample for analysis or did not have a pre- and postinfusion sample for immunogenicity.||Participants|||Number
171964|NCT00110461|Secondary|Change in Children’s Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4|Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171965|NCT00110461|Secondary|Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4|"Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject’s severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171966|NCT00110461|Secondary|Change in Children’s Global Assessment Scale (CGAS) Total Score at Week 4|"Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)~The CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Week 4|Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171967|NCT00110461|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30|"Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 30|Since the endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171968|NCT00110461|Primary|Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4|"Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.~Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 4|Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects be different number subjects included in the efficacy analysis.||points||Standard Deviation|Mean
171969|NCT00110396|Secondary|Number of Participants With Binding Antibodies (BAb) at Week 96|Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).|96 weeks|ITT (One participant did not have any post-baseline NAb assessments) LOCF imputation||Participants|||Number
171970|NCT00110396|Secondary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation||participants|||Number
171971|NCT00110396|Primary|Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.|The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.|96 weeks|ITT (One participant did not have any post-baseline NAb assessments). LOCF imputation||participants|||Number
171972|NCT00110357|Secondary|Grade 3/4 Laboratory Abnormalities - Hypomagnesemia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
171973|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Thrombocytopenia|Blood samples collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
171974|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Neutropenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe and undesirable AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
171975|NCT00110357|Secondary|Grade 3-4 Laboratory Abnormalities - Leukopenia|Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE|pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment|||Participants|||Number
171980|NCT00110357|Secondary|Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; VSS/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||L/m2||Standard Deviation|Mean
171981|NCT00110357|Secondary|Clearance Corrected for Body Surface Area (CL/BSA)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; CL/BSA was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||L/h/m2||Standard Deviation|Mean
171982|NCT00110357|Secondary|Terminal Half-Life (T-Half)|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; T-half was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||hours||Standard Deviation|Mean
171983|NCT00110357|Secondary|Area Under the Curve, Extrapolated to Infinity (AUC[INF])|The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; AUC(INF) was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||µg•h/mL||Standard Deviation|Geometric Mean
171984|NCT00110357|Secondary|Maximum Plasma Concentration (Cmax)|The single dose pharmacokinetics (PK) of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; Cmax was evaluated based on concentration-time profile.|up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study|||µg/mL||Standard Deviation|Geometric Mean
171985|NCT00110357|Secondary|Number of Participants With a Dose-Limiting Toxicity|Dose-limiting toxicities (DLTs)=serious drug side effects preventing further dose escalation. If 1 of the first 3 subjects developed a DLT during cycle 1 up to 3 additional subjects were enrolled at that dose level. The maximum dose level at which DLTs occurred in fewer than 2 out of 3 to 6 subjects was defined as the Maximum Tolerated Dose (MTD).|Prior to each 21-day cycle until dose-limiting toxicities|All treated subjects||Participants|||Number
171986|NCT00110305|Secondary|Number of Participants With Virologic Response (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm, by Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) Quartiles|Quartile 1, 2, 3 and 4 of AUC24h means the quartile with the lowest 25%, 26-50%, 51-75% and the highest 25% of AUC24h values, respectively, irrespective of the different doses of TMC278. For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96. Virologic response was calculated by time to loss of virologic response (TLOVR) algorithm.|Up to Week 96|Analysis included participants who received TMC278 with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter. Participants who discontinued treatment for reasons other than virological failure were excluded from this analysis.||Participants|||Number
171987|NCT00110305|Secondary|Trough Plasma Concentration (Ctrough) for TMC278|For each participant, a single value for trough (i.e. predose) plasma concentration (Ctrough) of TMC278 was estimated from a population pharmacokinetic model, based on samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharnacokintetic samples in order to derive population pharmacokinetic parameter.||ng/mL||Standard Deviation|Mean
171988|NCT00110305|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours (AUC24h) for TMC278|For each participant, a single value for area under the plasma concentration-time curve from time of administration up to 24 hours post dosing (AUC24h) of TMC278 was estimated from a population pharmacokinetic model, based on all samples collected throughout the trial up to Week 96.|Up to Week 96|Analysis included participants with sufficient number of pharmacokinetic samples in order to derive population pharmacokinetic parameter.||ng*h/mL||Standard Deviation|Mean
171989|NCT00110305|Secondary|Number of Participants With Virologic Failure for the Resistance Determinations by Developing Mutations: First Available On-Treatment Genotypic Data After Failure|Virologic failure for the resistance determinations was defined as a viral load greater than 0.5 log10 copies /mL above the nadir with a minimum of 500 copies/mL. For this study, treatment-emergent mutations (for at least one treatment) are presented as Resistance associated mutation (RAMs): i) Non-nucleotide reverse transcriptase inhibitor (NNRTI) RAMs, ii) Nucleoside/tide reverse transcriptase inhibitor (N[t]RTI RAMs).|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
171990|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Percentage of CD4+ cells||Standard Deviation|Mean
171991|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 240|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 240|ITT population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Cells per microliter||Standard Deviation|Mean
172003|NCT00110214|Primary|Overall Survival|Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
171992|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Relative) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat (ITT) population: Participants who received at least 1 dose of study medication. Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.||Percentage of CD4+ Cells||Standard Deviation|Mean
171993|NCT00110305|Secondary|Change From Baseline in CD4+ Cell Count (Absolute) at Week 96|Change from baseline in CD4+ cell count was imputed in case of missing values: in case of premature discontinuation, data were imputed with the baseline value after discontinuation (i.e. change=0, Non-Completer [NC] = Failure); otherwise last observation carried forward was applied.|Baseline (Day 1 of Week 0) to Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.Efavirenz group, 1 participant was excluded due to missing baseline CD4+ cell count.||Cells per microliter||Standard Deviation|Mean
171994|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 400 Copies/mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
171995|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 240 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
171996|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 240 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 240|Intent to treat population: Participants who received at least 1 dose of study medication. This was measured at Week 240 for the combined TMC278 and Efavirenz groups, as all TMC278 participants were switched after Week 96 initially to 75 mg and subsequently to 25 mg dose.||Participants|||Number
171997|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - Snapshot Analysis|The analysis is based on the last observed viral load data within the Week 96 window. Virologic response is defined as a viral load less than 50 copies/mL. Missing viral load was considered as non-response.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.||Participants|||Number
171998|NCT00110305|Secondary|Number of Participants With Virologic Response at Week 96 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 96|Intent to treat population: Participants who received at least 1 dose of study medication.||Participants|||Number
171999|NCT00110305|Primary|Number of Participants With Virologic Response at Week 48 (Viral Load Less Than 50 Copies Per mL) - as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 48|Intent to treat population: Participants who received at least 1 dose of study medication.||Participants|||Number
172000|NCT00110214|Secondary|Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities|"The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death"|During treatment (up to 2 years)|Participants who did not received allocated intervention were excluded from toxicity analysis.||percentage of participants|||Number
172001|NCT00110214|Secondary|Progression-free Survival (PFS)|"PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
172002|NCT00110214|Secondary|Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline|PSA decline will be reported on all patients and will be defined as a decrease in PSA value by >= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy.|Duration of study (up to 5 years)|||percentage of participants|||Number
172004|NCT00110136|Secondary|Mood is Measured by the POMS Short Form.|"POMS stands for the Profile of Mood States This is a short version of the POMS (17 questions).~Each question is scored on a 0 to 4 scale. The POMS score is the sum of the responses to the 17 questions. Responses to some questions have been reversed to make higher responses better.~The range is 0 to 68.~Higher scores represent better overall mood."|Baseline and four weeks|All registered participants.||units on a scale||Standard Deviation|Mean
172005|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (PCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). Now we'll summarize the PCS.~SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.~PCS is the physical health component of the SF-12. Normal population has a mean of 50 and a SD of 10. Higher scores reflect better physical health.~The range is 0 to 100.~Higher scores represent better mental health."|Baseline and four weeks|All registered participants.||units on a scale||Standard Deviation|Mean
172006|NCT00110136|Secondary|Effect of St. John's Wort on Quality of Life (MCS)|"Quality of life was measured by the SF12 (MCS and PCS subscales). First we'll summarize the MCS.~SF-12 is the short form Health Survey (a short version of the SF-36) developed for the Medical Outcomes Study. It is managed by QualityMetric.~MCS is the mental health component of the SF-12. A normal population has a mean of 50 and a SD of 10. Higher numbers represent better mental health.~The range is 0 to 100.~Higher scores represent better mental health."|Baseline and four weeks|All registered participants.||units on a scale||Standard Deviation|Mean
172007|NCT00110136|Secondary|Estimation of Toxicities While on St. John's Wort|Toxicities are quantified using the standard NCI toxicity criteria. The outcome is the percentage of participants who experience one or more toxicities. More detailed information on toxicities is found in the adverse events section.|Six weeks following baseline (four weeks of active treatment and two weeks of follow-up)|All registered participants||percentage of participants||95% Confidence Interval|Number
172008|NCT00110136|Secondary|Effect of St. John's Wort on Hot Flash Score as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|"The hot flash score is calculated as the frequency of hot flashes times the severity of the hot flashes averaged over a week.~Frequency is the number of hot flashes in a day. Severity is coded 0=None, 1=Mild, 2=Moderate, and 3=Severe. Score for each day is frequency times severity. Weekly score is averaged over seven days.~Score ranges from 0 to infinity~Lower scores are better."|Baseline and four weeks|All registered participants||frequency times severity||Standard Deviation|Mean
172009|NCT00110136|Primary|Effect of St. John's Wort on Hot Flash Frequency as Recorded in a Daily Hot Flash Diary From Baseline to 4 Weeks|Primary objective was to assess the change in hot flashes over a four week period in patients given St. John's Wort|Baseline and four weeks|All registered participants||number of occurrences||Standard Deviation|Mean
172010|NCT00110084|Secondary|Adverse Event|Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0|Every 6 weeks|||participants|||Number
172011|NCT00110084|Secondary|Overall Survival|Overall survival time was defined as the number of days from registration to the date of death or last follow-up|Death or last follow-up (up to 5 years)|Median survival time from Kaplan-meir estimate has not been attained.||months||95% Confidence Interval|Median
172012|NCT00110084|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.|Time from registration to progression or death (up to 5 years)|||months||95% Confidence Interval|Median
172013|NCT00110084|Primary|Proportion of Patients With Confirmed Responses|"Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.~Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."|Two consecutive evaluations at least 6 weeks apart|per protocol||participants|||Number
172014|NCT00110019|Secondary|Objective Response (Complete and Partial Response) Rate|Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.|Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.|Intention-to-treat population, n=823||proportion||95% Confidence Interval|Number
172015|NCT00110019|Secondary|Progression-free Survival|Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.|Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.|Intention-to-treat population, n=821, two patients had no information about date of progression, and were excluded from the analysis||months||95% Confidence Interval|Median
172016|NCT00110019|Primary|Overall Survival|Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.|Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.|Intention-to-treat population, n=823||months||95% Confidence Interval|Median
172017|NCT00109967|Secondary|Overall Survival|Overall survival (OS) was defined as the time from registration to death resulting from any cause. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed for survival status for up to 5 years.|||months||95% Confidence Interval|Median
172018|NCT00109967|Secondary|Toxicity|"As per the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) Version 3, toxicity was defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment by the treating physician.~In this section, we report the number of participants that experienced at least one Grade 3 or higher adverse event."|Assessed during treatment (up to 12, 28-day cycles)|||patients|||Number
172019|NCT00109967|Secondary|Duration of Response|Duration of response was defined as the time from the date of documented response to the date of progression. Patients who went off treatment due to other reasons (eg, adverse reactions, refusal of further treatment) were censored at that time. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Response duration is followed up to 5 years from registration.|Of the 48 Rituximab Sensitive patients, 30 patients had a response. Of the 21 Rituximab Refractory patients, 11 patients had a response. Therefore, this endpoint uses 30 patients from the Rituximab Sensitive group and 11 patients from the Rituximab Refractory group in the analysis.||months||95% Confidence Interval|Median
172020|NCT00109967|Secondary|Time to Progression|Time to progression was defined as the time from registration to the date of progression. Patients who died without disease progression were censored at the date of their last evaluation. Patients who were still receiving treatment at the time of these analyses were censored at the date of their last evaluation. The distribution of this time-to-event end point was estimated using the Kaplan-Meier method.|Patients were followed up to five years after registration.|||months||95% Confidence Interval|Median
172021|NCT00109967|Primary|Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria|"Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.~Partial Response (PR) requires a >=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses.~Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients.~We report the Overall Response Rate here."|Up to 12, 28-day cycles.|||percentage of patients||95% Confidence Interval|Number
172022|NCT00109928|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 18 weeks of protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
172023|NCT00109928|Secondary|Response Rate|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|up to 3 years or time of disease progression|All eligible patients who started protocol treatment were included in the analysis.||participants|||Number
172024|NCT00109928|Secondary|2-year Progression-free Survival Rate|Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.|0-2 years|All eligible patients who started protocol treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
172025|NCT00109928|Primary|2-year Overall Survival Rate|The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.|0-2 years|All eligible patients who started protocol treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
172026|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 24|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.|Baseline and Month 24|All enrolled participants who met the eligibility criteria.||Participants|||Count of Participants
172027|NCT00109876|Secondary|Change in Pulmonary Function From Baseline at Month 3|Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.|Baseline and Month 3|All enrolled participants who met the eligibility criteria.||Participants|||Count of Participants
172028|NCT00109876|Secondary|Incidence of Adverse Events|The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event. > Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.|Up to 2 years|All enrolled participants who met the eligibility criteria.||Participants|||Count of Participants
172029|NCT00109876|Secondary|Proportion of Technical Success|The proportion of technical success was estimated by the number of patients with a RFA > procedures deemed a technical success divided by the total number of RFA procedures > attempted from the qualified sites. The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.|Up to 2 years|All enrolled participants who met the eligibility criteria.||percentage of participants|||Number
172030|NCT00109876|Secondary|Overall Time to Recurrence|The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.|Up to 2 years|All enrolled participants who met the eligibility criteria.||years||95% Confidence Interval|Median
172031|NCT00109876|Secondary|Overall Time to Local Failure|The overall time to local failure was defined as the time from registration to documentation of > local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.|Up to 2 years|All enrolled participants who met the eligibility criteria.||years||95% Confidence Interval|Median
172034|NCT00109850|Secondary|Objective Response (Confirmed and Unconfined, Complete and Partial)|Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|at week 16, then every 3 months until progression|All eligible patients who started treatment and were evaluable for response were included in assessing response estimates.||percentage of participants||95% Confidence Interval|Number
172035|NCT00109850|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after every two cycles of chemotherapy.|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
172036|NCT00109850|Primary|Overall Survival at 2 Years|Measured from time of registration to date of death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis.||percentage of participants||95% Confidence Interval|Number
172037|NCT00109837|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events after the induction cycle|Eligible patients who started therapy||Participants with a given type of AE|||Number
172038|NCT00109837|Primary|Continuous Complete Remission at 1 Year|A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.|After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year|Eligible, Ph-, treated, and evaluable patients||participants|||Number
172039|NCT00109772|Secondary|Participants With Treatment-Emergent Adverse Events in the Double-Blind Period or the Extension Period|"Counts of study participants who had adverse events (AEs) while treated in either the Double-blind or Extension Periods. The NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 was used by the investigator to grade the severity of the AEs: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.~AEs are also summarized by whether they were serious, related to treatment and whether the AE caused treatment to be altered.~A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above."|Day 1 up to week 158|Safety population||participants|||Number
172040|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Sensory Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal sensory nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.||meters/second||Standard Deviation|Mean
172041|NCT00109772|Secondary|Change From Baseline in the Maximal Composite Motor Nerve Conduction Velocity at Week 12|An electrophysiological evaluation using standard electrophysiological and electromyography to measure the speed and extent of nerve conduction. Week 12 values are compared to baseline values for maximal motor nerve conduct velocity.|Day 0, week 12|Intent to treat population. Fifty participants did not have week 12 values.||meters/second||Standard Deviation|Mean
172042|NCT00109772|Secondary|Participants Who Had a Change to CRPS Pain Medication During the Treatment Period|Participants who had any change in CRPS medication during the double-blind treatment period (up to week 12) are summarized. Changes include additions, discontinuations or dosage change of CRPS medication(s).|Day 1 to week 12|Intent to treat population||participants|||Number
172043|NCT00109772|Secondary|Patient Global Impression of Change (PGIC) at Week 12|The Patient Global Impression of Change asks the question: Overall, how would you rate your CRPS condition since the start of study drug? Answers are represented on a seven-point scale with -3=much worst and +3=much better.|Week 12|Intent to treat. Forty-five participants had no week 12 values.||units on a scale||Standard Deviation|Mean
172044|NCT00109772|Secondary|Change From Baseline in the Profile of Mood States (POMS) at Week 12|Participants completed the Profile of Mood States questionnaire that asks participants to rate how each of 65 words reflected their mood in the past week on a 5-point scale with 0=not at all and 4=extremely for a total scale of 0-260. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Six participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172045|NCT00109772|Secondary|Change From Baseline in the Brief Pain Inventory (BPI) Total Score at Week 12|Participants completed the Brief Pain Inventory which asks twelve questions that are rated on an eleven-point scale in which 0=most positive outcome and 10=the most negative outcome for a total scale of 0-120. BPI contains questions that concern the level of pain over the last week and the level of pain right now, the extent to which pain interfered with sleep, normal activities, ability to work, relationships, walking etc. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172046|NCT00109772|Secondary|Difference in Allodynia Rating Between the CRPS-affected Limb and the Normal Limb at Week 12|The investigator rated the degree of allodynia on both the CRPS-affected limb and the normal (or less-affected) limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the values for the CRPS affected-limb to the normal limb at week 12.|Week 12|Intent to treat population. Last observation carried forward. Fifteen participants were missing values.||units on a scale||Standard Deviation|Mean
172047|NCT00109772|Secondary|Change From Baseline in “Mechanically Evoked” (Allodynia) Numeric Rating Scale (NRS) Score at Week 12|The investigator rated the degree of allodynia on both the CRPS-affected limb on an eleven-point scale where 0=no pain and 10=worst pain imaginable. This outcome compares the baseline values for the CRPS affected-limb to the values at week 12. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Sixteen participants had either no baseline or post-treatment values.||units on a scale||Standard Deviation|Mean
172048|NCT00109772|Secondary|Change From Baseline in Participant Assessment of CRPS Symptoms Total Score at Week 12|Participants rated twelve CRPS symptoms using a four-point rating scale in which 1=the most positive outcome and 4= the most negative outcome for a total scale of 12-48. Week 12 values are compared to baseline values. Negative change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Thirty-three participants had either no baseline or post-treatment values.||units on a scale||Standard Deviation|Mean
172049|NCT00109772|Secondary|Change From Baseline in Activity Level Rating Using a Numeric Rating Scale (NRS) at Week 12|Participants rated how the activity level on a given day compares with their activity level prior to the start of treatment. A seven-point scale is used with -3=much worse and +3=much better. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172050|NCT00109772|Secondary|Change From Baseline in Daily Sleep Assessment Average Score at Week 12|Participants rated how much CRPS pain interfered with their sleep each day in a diary. The Sleep Assessment uses an eleven point scale for four questions. Questions concern ability to fall asleep, ability to stay asleep, how refreshed the participant feels upon waking and how alert the participant is during the day. All use a scale of 0-10, where the higher number is the positive response (e.g. 0=Pain completely interferes with sleep and 10=Pain does not interfere). The mean of all four responses was calculated if at least 3 of the 4 questions had a value. Week 12 values are compared to baseline values. Positive change values indicate improvement.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172051|NCT00109772|Secondary|Change From Baseline in the Evening Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The evening pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172052|NCT00109772|Secondary|Change From Baseline in the Morning Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. The morning pain ratings at baseline and Week 12 are compared. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172053|NCT00109772|Secondary|Change From Baseline in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score Using Averaged Morning and Evening Readings at Week 12|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. Morning and evening scores are averaged. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat population. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172054|NCT00109772|Secondary|Change From Baseline in the Total Score of the Short Form McGill Pain Questionnaire (SF-MPQ) at Week 12|Short Form McGill Pain Questionnaire (SF-MPQ) is comprised of 15 pain qualities that are rated by the participant on a 4 point scale with 0=none and 3=severe. The scale for the Total Score is 0-45. Week 12 values are compared to baseline values. Negative changes indicate improvement in level of pain.|Day 0, week 12|Intent to treat. Last observation carried forward. Three participants had no post-treatment values.||units on a scale||Standard Deviation|Mean
172055|NCT00109772|Primary|Percentage of Participants Who Have a >= 30% Reduction (Improvement) in the Complex Regional Pain Syndrome (CRPS) Pain Intensity Numeric Rating Scale (PI-NRS) Score From Baseline to the Last Assessment|Participants rated the intensity of pain in the CRPS-affected limb twice each day in a diary. The PI-NRS is an eleven point scale with 0=no pain and 10=worst pain imaginable. Responders are participants who completed 12 weeks of treatment and their week 12 PI-NRS score showed at least a 30% improvement from baseline. Participants who did not complete 12 weeks of treatment are considered non-responders.|Day 0, Week 12|Intent to treat||percentage of participants|||Number
172056|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Trunk to Limb Fat Ratio||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
172057|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Limb Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
172058|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Total Body Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
172059|NCT00109733|Secondary|Percent Change From Baseline to Week 24 in Lean Body Mass||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
172060|NCT00109733|Primary|Percent Change From Baseline to Week 24 in Trunk Fat||Baseline to Week 24|Intention To Treat, Last Observation Carried Forward||percent change||Standard Deviation|Mean
172088|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 14 – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
172061|NCT00109590|Primary|Four (4) Hour Concentration Pharmacokinetic Outcome for LPV/r (C4hour ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug/mL||Full Range|Median
172062|NCT00109590|Primary|Pre-dose Concentration Pharmacokinetic Outcome for LPV/r (Cpredose ug/mL).|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug/mL||Full Range|Median
172063|NCT00109590|Primary|Maximum Concentration Pharmacokinetic Outcome for LPV/r (Cmax ug/mL) .|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug/mL||Full Range|Median
172064|NCT00109590|Secondary|Median Viral Load (log10 Copies/ml) at 24 Weeks Postpartum in Women||at 24 weeks postpartum|The number of particpants included in this analyses were for those for whom viral loads were available at 24 weeeks postpartum.||participants||Full Range|Median
172065|NCT00109590|Secondary|Resistance Mutations in HIV Infected Infants|Resistance mutations as identified by consensus sequencing or OLA|24 weeks postpartum|Amongst the infants who became HIV-infected.||participants|||Number
172066|NCT00109590|Secondary|Proportion of Women With New NVP Resistance Mutation Within 8 Weeks Postpartum Who Had a NVP Resistance Mutation Detected at 72 Weeks Postpartum.|Resistance mutations as identified by OLA in plasma samples or PBMC at 72 weeks postpartum amongst women who had new NVP resistance mutations within 8 weeks postpatrum. These results were based on the 13 women who developed a new NVP resistance mutation in the first 8 weeks postpartum. For the primary outcome measure 1, one particpant in arm A was unavailable for follow-up after week 5 and was conservatively imputed to have developed resistance mutation.|within 72 weeks postpartum|amongst the participants who developed resistance within 8 weeks postpartum||participants|||Number
172067|NCT00109590|Secondary|Number of Women With Grade >=3 Events After Start of Study Treatment|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading > the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities (and events of any grade that led to a change in study treatment) were included.|After start of study Treatment (postpartum)|All women who started treatment were included in an intention-to-treat analysis.||participants|||Number
172068|NCT00109590|Secondary|The Proportion of Women With Any New ZDV, ddI, or LPV/r Resistance Mutations.||At Week 5 postpartum (ZDV) and at the first timepoint with viral load >=500 copies/ml after treatment discontinuation (ddI and LPV/r).|All women who started treatment were included in an intention-to-treat analysis||percent of participants|||Number
172069|NCT00109590|Secondary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations for the Subgroup of Women With Plasma HIV RNA >= 500 Copies/ml At Entry|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|Includes only the Subgroup of women with Plasma HIV RNA >= 500 copies/ml at Entry and who started treatment; analyzed using the intention-to-treat principle (according to assigned treatment, regardless of compliance with the protocol).||percent of participants||95% Confidence Interval|Number
172070|NCT00109590|Primary|Area Under the Curve Pharmacokinetic Outcome for LPV/r. (AUC ug*hr/mL)|Data was analyzed with WinNonLin (Version 5.2, Pharsight, USA) using non-compartmental methods. The pharmacokinetic parameters were calculated using the linear-trapezoidal rule. Cpredose and C4hour at the two measurement times were compared within-subject using the Wilcoxon signed-rank test.|Within 72 hours postpartum and during the first 30 days postpartum|18 women were enrolled in this sub study,PK sampling was not performed in 2 women. Of the remaining 16 women, all completed the LPV/r PK sampling within 72 hours after delivery and at day 30 postpartum and had evaluable PK within 72 hours delivery but only 14 women had evaluable PK results at day 30 postpartum due to suspected poor drug adherence.||ug*hr/mL||Full Range|Median
172071|NCT00109590|Primary|The Proportion of Women in Each Randomized Arm Who Have One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay (OLA) in Plasma|The incidence of new NVP resistance mutations at day 10 or week 6 postpartum in each randomized arm. Samples with viral load <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml it was conservatively imputed as resistant in the primary analysis.|at Day 10 or Week 6 postpartum.|All women who started treatment were included in an intention-to-treat analysis (according to randomized treatment assignment, regardless of compliance with the protocol)||percent of participants||95% Confidence Interval|Number
172089|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 9V – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
172072|NCT00109590|Primary|The Proportion of Women Who Develop One or More New NVP Resistance Mutations as Identified by Consensus Sequencing or Oligonucleotide Ligation Assay in Plasma (Sampling Was Done at Days 10,21,30, and Weeks 5,6, and 8 Postpartum).|The incidence of new NVP resistance mutation in plasma HIV within 8 weeks postpartum in each randomized arm was estimated using an exact binomial confidence interval. If a resistance mutation was detected at any of the timepoints then an endpoint was met. Samples with VL <500 copies/mL were considered free of mutations. If a resistance result was missing for reasons other than VL <500 copies/ml (e.g.missed visit), it was conservatively imputed as resistant in the primary analysis.|within 8 weeks postpartum.|All women who started treatment were included in an intention-to-treat analysis.||percent of participants||95% Confidence Interval|Number
172073|NCT00109577|Secondary|Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)||Baseline to 8 weeks||||||
172074|NCT00109577|Secondary|Outcome Questionnaire --- a Self-report Questionnaire||Baseline to 8 weeks||||||
172075|NCT00109577|Secondary|Global Clinical Impressions||Baseline to 8 weeks||||||
172076|NCT00109577|Primary|Mood as Evaluated by the Overall Bipolarity Index (Composite of the Hamilton Depression Scale and the Young Mania Rating Scale)|Change in mood from baseline to final visit, as evaluated by the Overall Bipolarity Index (composite of the Hamilton Depression Scale and the Young Mania Rating Scale); minimum possible score is 0 and maximum possible score is 103; higher scores mean worse symptomatology|Baseline to 8 weeks|All participants were included, since the analysis was intent-to-treat with last observation carried forward||units on a scale||Standard Deviation|Mean
172077|NCT00109473|Secondary|Fecal Calprotectin|Fecal calprotectin is a previously validated stool marker of intestinal inflammation in Crohn's Disease.|At 24 and 64 weeks|||micrograms per gram (microg/g)||95% Confidence Interval|Mean
172078|NCT00109473|Secondary|Height Velocity|"Height velocity was computed every 12 weeks up to week 64 and then yearly during the Maintenance study. Since 40 to 80% of children with Crohn's disease have significant growth failure at diagnosis, height velocity is used to track for changes in height.~It is calculated by measuring height at two points of time and then dividing the change by the amount of time."|Baseline, week 12, 24 and 48|||cm/year||Standard Error|Mean
172079|NCT00109473|Secondary|Crohn's Disease Endoscopic Index of Severity (CDEIS)|Measure of mucosal disease at baseline and week 12 obtained during colonoscopy. The CDEIS score generally ranges from 0–30. A higher score indicates more severe mucosal inflammation.|Baseline and 12 weeks|||Scores on a scale||95% Confidence Interval|Mean
172080|NCT00109473|Secondary|Total Corticosteroid Use||12 weeks, 24 weeks||||||
172081|NCT00109473|Secondary|Pediatric Crohn's Disease Activity Index (PCDAI)|The PCDAI is a previously validated measure of clinical disease activity for children with CD. It contains three self-report items which reflect patient abdominal pain, diarrhea, and general well being; three laboratory values; height and weight velocity; and three physical examination parameters reflecting abdominal tenderness, perirectal disease, and extra-intestinal manifestations. Scores may range from 0-100. Remission is defined as 0-10, mild disease as 10-30, and moderate to severe disease as greater than 30.|Baseline, 12 and 24 weeks|||Scores on a scale||95% Confidence Interval|Mean
172082|NCT00109473|Secondary|IMPACT III Score|Health-related quality of life (QOL)was assessed using the IMPACT 111 questionnnaire. It is a self-administered 35 item questionnaire which typically takes 10-15 minutes to complete. Scores range from 0-350, with higher scores reflecting better perceived quality of life.|Baseline, 12 weeks, 24 weeks|||Scores on a scale||95% Confidence Interval|Mean
172083|NCT00109473|Secondary|Serum IGF-1 (Insulin-like Growth Factor 1)z Score|"Elevated serum IGF-1 levels have been implicated in the development of colorectal cancer, both in the general population and in patients with an excess of growth hormone production. The serum IGF-1 levels were monitored to maintain them in the physiologic range during growth hormone therapy to reduce the risk of tumorigenesis.~The levels are reported as a z score, a statistical way of standardizing data. The standard deviation is the unit of measurement of the z-score. Each z score corresponds to a point in a normal distribution, describing how much a point deviates from a mean."|Baseline, 12 weeks, 24 weeks|||Z score||Standard Error|Mean
172084|NCT00109473|Primary|Crohn's Disease Histologic Index of Severity (CDHIS)|The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16|Baseline and 12 weeks|||scores on a scale||95% Confidence Interval|Number
172085|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 23F – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
172086|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 19F – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
172087|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 18C – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
172104|NCT00107900|Secondary|Change From Baseline for International Normalized Ratio (INR) Results|Intent to Treat (ITT) population|end of treatment|ITT population||INR ratio||Standard Deviation|Mean
172105|NCT00107900|Secondary|Change From Baseline for Prothrombin Time (PT) Results|Intent to Treat (ITT) population|end of treatment|ITT population||seconds||Standard Deviation|Mean
172090|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 6B – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone.|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
172091|NCT00109343|Primary|Antibody Response to S. Pneumoniae Serotype 4 – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||mcg/mL||95% Confidence Interval|Geometric Mean
172092|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
172093|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
172094|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
172095|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
172096|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
172097|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
172098|NCT00109343|Other Pre-specified|Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4||6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges and followed protocol procedures.||Participants|||Number
172099|NCT00109343|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.||Participants|||Number
172100|NCT00109343|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.||Participants|||Number
172101|NCT00109343|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 ELISA Ab units/mL) to Mumps at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.||Participants|||Number
172102|NCT00109343|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <255 mIU/mL) to 